id|nct_id|outcome_id|non_inferiority_type|non_inferiority_description|param_type|param_value|dispersion_type|dispersion_value|p_value_modifier|p_value|ci_n_sides|ci_percent|ci_lower_limit|ci_upper_limit|ci_upper_limit_na_comment|p_value_description|method|method_description|estimate_description|groups_description|other_analysis_description|ci_upper_limit_raw|ci_lower_limit_raw|p_value_raw
72622146|NCT04003142|144774326|SUPERIORITY||Odds Ratio (OR)|0.798||||0.741||95.0|0.194|3.079||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 3||3.079|0.194|0.741
72370733|NCT05475483|144251666|OTHER||Mean Difference (Final Values)|-1.27|||=|0.045|TWO_SIDED|95.0|-2.51|-0.03|||Mixed Models Analysis|||||-0.03|-2.51|= 0.045
72370734|NCT05475483|144251667|OTHER||Odds Ratio (OR)|2.22|||=|0.078|TWO_SIDED|95.0|0.91|5.37|||Regression, Logistic|||||5.37|0.91|= 0.078
72370735|NCT05475483|144251668|OTHER||Odds Ratio (OR)|1.95||||0.143|TWO_SIDED|95.0|0.8|4.76|||Regression, Logistic|||||4.76|0.80|0.143
72370736|NCT05475483|144251669|OTHER||Mean Difference (Final Values)|-1.78|||=|0.032|TWO_SIDED|95.0|-3.4|-0.16|||Mixed Models Analysis|||||-0.16|-3.40|= 0.032
72370737|NCT02923921|144251695|SUPERIORITY||Hazard Ratio (HR)|1.045||||0.6565|TWO_SIDED|95.0|0.863|1.265|||Log Rank|||The primary test to compare overall survival between treatment arms was the two-sided log-rank test, stratified by region and prior therapy. The estimate of the hazard ration (HR) - (Pegilodecakin + FOLFOX Arm / FOLFOX Arm) and the corresponding 95% CI was computed using a Cox proportional hazards model stratified by randomization stratification factors. Randomization stratification factors were based on the data recorded in interactive voice response system (IVRS).||1.265|0.863|0.6565
72370738|NCT02923921|144251696|SUPERIORITY||Hazard Ratio (HR)|0.981||||0.8144|TWO_SIDED|95.0|0.808|1.19|||Log Rank|||The estimate of hazard ratio (HR) was stratified by region and prior therapy.||1.190|0.808|0.8144
72370739|NCT02923921|144251697|SUPERIORITY||Odds Ratio (OR)|0.8||||0.7044|TWO_SIDED|95.0|0.4|1.7||P-value is calculated by Exact Cochran-Mantel-Haenszel test stratified by the randomization strata Prior Therapy - interactive voice response system (IVRS), Geographic Region - IVRS.|Cochran-Mantel-Haenszel|||||1.7|0.4|0.7044
72370740|NCT02923921|144251698|SUPERIORITY||Odds Ratio (OR)|1.3||||0.1463|TWO_SIDED|95.0|0.9|1.8||P-value is calculated by Exact Cochran-Mantel-Haenszel test stratified by the randomization strata Prior Therapy - interactive voice response system (IVRS), Geographic Region - IVRS.|Cochran-Mantel-Haenszel|||||1.8|0.9|0.1463
72370741|NCT02923921|144251699|SUPERIORITY||Hazard Ratio (HR)|1.008||||0.9952|TWO_SIDED|95.0|0.37|2.741|||Log Rank|||The estimate of hazard ratio (HR) was stratified by region and prior therapy.||2.741|0.370|0.9952
72370742|NCT02923921|144251700|SUPERIORITY||Mean Difference (Final Values)|-4.4||||0.2298|TWO_SIDED|95.0|-11.6|2.8|||Log Rank|||||2.8|-11.6|0.2298
72370743|NCT00479687|144251701|SUPERIORITY|||||||0.038||||||There was a single primary variable and the a-prior threshold for statistical significance was 0.05.|Mixed Models Analysis|mixed effects repeated measure model with baseline VAS, treatment, and week as fixed effects and subject nested within site as a random effect.||||||0.0380
72370744|NCT01474239|144251710|SUPERIORITY_OR_OTHER|||||||0.4291|TWO_SIDED|||||Statistical significance was assessed with a one-sided alpha error of 10 percent (%).|Exact Binomial Test|||The 6-month OS rate (OS-6) for bevacizumab was compared to the expected proportion of 0.60 under null hypothesis (ineffective treatment) with the application of the exact binomial test. The one-tailed statistical hypotheses was p0 less than or equal to (≤) 0.60 (null hypothesis) versus pA greater than or equal to (≥) 0.77 (alternative hypothesis), where p is the estimated probability of survival at 6 months.||||0.4291
72370745|NCT00459732|144251732|SUPERIORITY_OR_OTHER_LEGACY|||||||0.13|TWO_SIDED|95.0|||||ANOVA|||||||0.13
72370746|NCT00459732|144251733|SUPERIORITY_OR_OTHER_LEGACY|||||||0.44|TWO_SIDED|95.0|||||ANOVA|Repeated measures||||||0.44
72370747|NCT00459732|144251734|SUPERIORITY_OR_OTHER_LEGACY|||||||0.16|TWO_SIDED|95.0|||||ANCOVA|Repeated measures analysis of variance adjusted for baseline osteocalcin level.||||||0.16
72370748|NCT03983317|144251766|OTHER|We tested if the average drinks consumed was statistically different in Week 2 of the Treatment Phase vs. the Baseline Phase. This was evaluated via a paired t-test.||||||0.026|||||||t-test, 2 sided|Paired t-test||||||0.026
72370749|NCT03983317|144251768|OTHER|We tested if the average craving intensity was statistically different in Week 2 of the Treatment Phase vs. the Baseline Phase. This was evaluated via a paired t-test.||||||0.001|||||||t-test, 2 sided|Paired t-test||||||0.001
72370750|NCT02785770|144251825|SUPERIORITY_OR_OTHER||LS mean difference|0.96||||0.454|TWO_SIDED|90.0|-1.15|3.07|||Repeated Measures Model|||Moxifloxacin 400 mg versus Placebo, 0.5 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||3.07|-1.15|0.4540
72622147|NCT04003142|144774326|SUPERIORITY||Odds Ratio (OR)|2.292||||0.134||95.0|0.809|7.443||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 3||7.443|0.809|0.134
72370751|NCT02785770|144251825|SUPERIORITY_OR_OTHER||LS mean difference|7.88|||<|0.0001|TWO_SIDED|90.0|5.77|9.99|||Repeated Measures Model|||Moxifloxacin 400 mg versus Placebo, 1 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||9.99|5.77|< 0.0001
72370752|NCT02785770|144251825|SUPERIORITY_OR_OTHER||LS mean difference|11.33|||<|0.0001|TWO_SIDED|90.0|9.22|13.44|||Repeated Measures Model|||Moxifloxacin 400 mg versus Placebo, 2 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||13.44|9.22|< 0.0001
72370753|NCT02785770|144251825|SUPERIORITY_OR_OTHER||LS mean difference|8.59|||<|0.0001|TWO_SIDED|90.0|6.48|10.7|||Repeated Measures Model|||Moxifloxacin 400 mg versus Placebo, 3 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||10.70|6.48|< 0.0001
72370754|NCT02785770|144251825|SUPERIORITY_OR_OTHER||LS mean difference|8.96|||<|0.0001|TWO_SIDED|90.0|6.85|11.07|||Repeated Measures Model|||Moxifloxacin 400 mg versus Placebo, 4 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||11.07|6.85|< 0.0001
72370755|NCT02785770|144251825|SUPERIORITY_OR_OTHER||LS mean difference|8.07|||<|0.0001|TWO_SIDED|90.0|5.96|10.18|||Repeated Measures Model|||Moxifloxacin 400 mg versus Placebo, 8 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||10.18|5.96|< 0.0001
72431805|NCT01955382|144375664|SUPERIORITY||||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||||||>0.05
72431806|NCT01195675|144375707|NON_INFERIORITY_OR_EQUIVALENCE|Empa vs placebo|Mean Difference (Final Values)|0.59|STANDARD_ERROR_OF_MEAN|0.76|||TWO_SIDED|90.0|-0.69|1.87|||ANCOVA|Based on ANCOVA with terms for sequence, subjects within sequence, period, treatment and baseline.|Mean difference = Empa minus placebo|Non-inferiority margin: 10ms||1.87|-0.69|
72614672|NCT01035788|144759407|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.39|STANDARD_ERROR_OF_MEAN|7.24||0.849|TWO_SIDED|95.0|-1.39|13.2|||Mixed Models Analysis|p value was obtained from the contrast of the linear mixed model||We sought to obtain a sample size of 18 per group to provide 80% power to detect a .97 standard deviation difference in mean change in CAPS between MB-CBCT and the CBCT-Communication Skills at treatment end based on a two-tailed t-test at 5% significance. Linear mixed models with repeated measures were performed to address the primary hypotheses that MB-CBCT would result in a greater improvement for Veterans and their partners than CBCT-Communication Skills at the end of treatment.||13.2|-1.39|.849
72614673|NCT01001104|144759409|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||This is the p-value for the linear trend test at 12 weeks.|Mixed Models Analysis|||||||<.001
72614674|NCT01001104|144759409|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.72|||<|0.001||95.0|||||Mixed Models Analysis|||||||<0.001
72614675|NCT01001104|144759409|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.97|||<|0.001||95.0|||||Mixed Models Analysis|||||||<0.001
72614676|NCT01001104|144759409|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-1.17|||<|0.001||95.0|||||Mixed Models Analysis|||||||<0.001
72431807|NCT01195675|144375708|NON_INFERIORITY_OR_EQUIVALENCE|Empa vs placebo. Non-confirmatory testing.|Mean Difference (Final Values)|0.66|STANDARD_ERROR_OF_MEAN|0.62|||TWO_SIDED|90.0|-0.38|1.71|||ANCOVA|Based on ANCOVA with terms for sequence, subjects within sequence, period, treatment and baseline.|Mean difference = Empa minus placebo|Non-inferiority margin: 10ms||1.71|-0.38|
72431808|NCT01195675|144375709|NON_INFERIORITY_OR_EQUIVALENCE|Empa vs placebo. Non-confirmatory testing.|Mean Difference (Final Values)|-0.15|STANDARD_ERROR_OF_MEAN|0.65|||TWO_SIDED|90.0|-1.23|0.93|||ANCOVA|Based on ANCOVA with terms for sequence, subjects within sequence, period, treatment and baseline.|Mean difference = Empa minus placebo|Non-inferiority margin: 10ms||0.93|-1.23|
72431809|NCT01195675|144375710|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.42|STANDARD_ERROR_OF_MEAN|1.01|<|0.0001|TWO_SIDED|90.0|10.73|14.11|||ANCOVA|Based on ANCOVA with terms for treatment, period, treatment sequence, baseline and subject within sequence.|Non-confirmatory testing. Mean difference = Moxifloxacin minus placebo.|||14.11|10.73|<0.0001
72469363|NCT03721172|144462400|SUPERIORITY||Adjusted difference|38.0|||<|0.0001|TWO_SIDED|95.0|29.7|46.3|||Cochran-Mantel-Haenszel|Stratification were based on baseline sPGA (2 \[mild\] vs 3 \[moderate\]).|2-sided 95% CIs based on the stratified Newcombe method. Stratification were based on baseline sPGA (2 \[mild\] vs 3 \[moderate\]).|||46.3|29.7|<0.0001
72614677|NCT01001104|144759410|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||This is the p-value from the Cochran-Armitage trend test.|Cochran-Armitage|||||||<0.001
72614678|NCT01001104|144759410|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Fisher Exact|||||||<0.001
72614679|NCT01001104|144759410|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Fisher Exact|||||||<0.001
72614680|NCT01001104|144759410|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Fisher Exact|||||||<0.001
72614681|NCT01001104|144759411|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||This is the p-value from the Cochran-Armitage trend test.|Cochran-Armitage|||||||<0.001
72614682|NCT01001104|144759411|SUPERIORITY_OR_OTHER|||||||0.358||95.0|||||Fisher Exact|||||||0.358
72614683|NCT01001104|144759411|SUPERIORITY_OR_OTHER|||||||0.014||95.0|||||Fisher Exact|||||||0.014
72614684|NCT01001104|144759411|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Fisher Exact|||||||<0.001
72614685|NCT01001104|144759412|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||This is the p-value for the linear trend test at week 12.|Mixed Models Analysis|||||||<0.001
72614686|NCT01001104|144759412|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-20.2||||0.003||95.0||||Primary comparisons are based on the MMRM Least Squares (LS) Mean Value at week 12.|Mixed Models Analysis|||||||0.003
72614687|NCT01001104|144759412|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-19.54||||0.003||95.0||||Primary comparisons are based on the MMRM LS Mean Value at week 12.|Mixed Models Analysis|||||||0.003
72614688|NCT01001104|144759412|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-28.48|||<|0.001||95.0||||Primary comparisons are based on the MMRM LS Mean Value at week 12.|Mixed Models Analysis|||||||<0.001
72614689|NCT01001104|144759413|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||This is the p-value for the linear trend test at week 12.|Mixed Models Analysis|||||||<0.001
72614690|NCT01001104|144759413|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-33.2|||<|0.001||95.0||||Primary comparisons are based on the MMRM Least Squares (LS) Mean Value at week 12.|Mixed Models Analysis|||||||<0.001
72614691|NCT01001104|144759413|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-45.63|||<|0.001||95.0||||Primary comparisons are based on the MMRM LS Mean Value at week 12.|Mixed Models Analysis|||||||<0.001
72614692|NCT01001104|144759413|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-41.49|||<|0.001||95.0||||Primary comparisons are based on the MMRM LS Mean Value at week 12.|Mixed Models Analysis|||||||<0.001
72614693|NCT01001104|144759414|SUPERIORITY_OR_OTHER|||||||0.987||95.0||||This is the p-value for the linear trend test at week 12.|Mixed Models Analysis|||||||0.987
72614694|NCT01001104|144759414|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|1.26||||0.005||95.0||||Primary comparisons are based on the MMRM Least Squares (LS) Mean Value at week 12.|Mixed Models Analysis|||||||0.005
72614695|NCT01001104|144759414|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.45||||0.311||95.0||||Primary comparisons are based on the MMRM LS Mean Value at week 12.|Mixed Models Analysis|||||||0.311
72614696|NCT01001104|144759414|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.26||||0.556||95.0||||Primary comparisons are based on the MMRM LS Mean Value at week 12.|Mixed Models Analysis|||||||0.556
72614697|NCT01001104|144759415|SUPERIORITY_OR_OTHER|||||||0.202||95.0||||This is the p-value from the linear trend test at week 12.|Mixed Models Analysis|||||||0.202
72614698|NCT01001104|144759415|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.91||||0.917||95.0||||Primary comparisons are based on the MMRM Least Squares (LS) Mean Value at week 12.|Mixed Models Analysis|||||||0.917
72614699|NCT01001104|144759415|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-9.81||||0.264||95.0||||Primary comparisons are based on the MMRM LS Mean Value at week 12.|Mixed Models Analysis|||||||0.264
72614700|NCT01001104|144759415|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-8.4||||0.346||95.0||||Primary comparisons are based on the MMRM LS Mean Value at week 12.|Mixed Models Analysis|||||||0.346
72614701|NCT01001104|144759416|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||This is the p-value for the linear trend test at week 12.|Mixed Models Analysis|||||||<0.001
72614702|NCT01001104|144759416|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|13.1||||0.036||95.0||||Primary comparisons are based on the MMRM Least Squares (LS) Mean Value at week 12.|Mixed Models Analysis|||||||0.036
72614703|NCT01001104|144759416|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|19.73||||0.002||95.0||||Primary comparisons are based on the MMRM LS Mean Value at week 12.|Mixed Models Analysis|||||||0.002
72614704|NCT01001104|144759416|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|31.68|||<|0.001||95.0||||Primary comparisons are based on the MMRM LS Mean Value at week 12.|Mixed Models Analysis|||||||<0.001
72614705|NCT01001104|144759418|SUPERIORITY_OR_OTHER|||||||0.073||95.0||||This is the p-value from the Cochran-Armitage trend test (dose-effect).|Cochran-Armitage|||||||0.073
72614706|NCT01001104|144759418|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|||||||1.00
72370756|NCT02785770|144251825|SUPERIORITY_OR_OTHER||LS mean difference|5.53|||<|0.0001|TWO_SIDED|90.0|3.42|7.64|||Repeated Measures Model|||Moxifloxacin 400 mg versus Placebo, 12 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||7.64|3.42|< 0.0001
72492987|NCT03036293|144514786|SUPERIORITY||Mean Difference (Final Values)|1.56||||0.0055|TWO_SIDED|98.33|0.217|2.91|||ANCOVA|Baseline score used as covariate||Mean score differences (begin-end) were compared||2.91|0.217|0.0055
72614707|NCT01001104|144759418|SUPERIORITY_OR_OTHER|||||||0.233||95.0|||||Fisher Exact|||||||0.233
72614708|NCT02397837|144759419|OTHER|||||||0.38|||||||t-test, 2 sided|||||||0.38
72614709|NCT02397837|144759420|OTHER|||||||0.22|||||||t-test, 2 sided|||||||0.22
72614710|NCT02397837|144759421|OTHER|||||||0.17|||||||t-test, 2 sided|||||||0.17
72614711|NCT02397837|144759422|OTHER|||||||0.55|||||||t-test, 2 sided|||||||0.55
72614712|NCT02397837|144759423|OTHER|||||||0.99|||||||t-test, 2 sided|||||||0.99
72614713|NCT02397837|144759424|OTHER|||||||0.98|||||||t-test, 2 sided|||||||0.98
72614714|NCT02397837|144759425|OTHER||||||||||||||||||Tabulation of participants with suicidal acknowledgements over 12-week study|||
72614715|NCT02397837|144759426|OTHER|||||||0.09|||||||t-test, 2 sided|||||||0.09
72614716|NCT02397837|144759427|OTHER|||||||1|||||||t-test, 2 sided|||||||1.00
72614717|NCT02397837|144759428|OTHER|||||||0.17|||||||t-test, 2 sided|||||||0.17
72614718|NCT00817063|144759455|SUPERIORITY||Odds Ratio (OR)|3.78|||<|0.001|TWO_SIDED|95.0|2.55|5.62|||Chi-squared, Corrected|||||5.62|2.55|<0.001
72614719|NCT00817063|144759455|SUPERIORITY||Difference in Percentage|24.8|||<|0.001|TWO_SIDED|95.0|18.0|31.7|||Chi-squared, Corrected|||||31.7|18.0|<0.001
72614720|NCT00817063|144759456|SUPERIORITY||Mean Difference (Net)|-24.13|||<|0.001|TWO_SIDED|95.0|-30.4|-17.85|||Kruskal-Wallis|||||-17.85|-30.40|<0.001
72614721|NCT00817063|144759457|SUPERIORITY||Odds Ratio (OR)|4.05|||<|0.001|TWO_SIDED|95.0|2.71|6.07|||Chi-squared, Corrected|||||6.07|2.71|<0.001
72614722|NCT00817063|144759457|SUPERIORITY||Difference in Percentage|25.5|||<|0.001|TWO_SIDED|95.0|18.7|32.3|||Chi-squared, Corrected|||||32.3|18.7|<0.001
72614723|NCT00817063|144759458|SUPERIORITY||Mean Difference (Net)|-22.36|||<|0.001|TWO_SIDED|95.0|-31.0|-13.73|||Kruskal-Wallis|||||-13.73|-31.00|<0.001
72614724|NCT00817063|144759459|SUPERIORITY|||||||0.047|||||||Log Rank|||||||0.047
72614725|NCT00817063|144759460|SUPERIORITY|||||||0.068|||||||Log Rank|||||||0.068
72614726|NCT00817063|144759461|SUPERIORITY||||||<|0.001|||||||Log Rank|||||||<0.001
72614727|NCT00817063|144759470|SUPERIORITY||Mean Difference (Net)|0.489||||0.179|TWO_SIDED|95.0|-0.226|1.204||The analysis of covariance model includes treatment, age at Baseline, gender, menopausal status of females, baseline BMD score and duration of treatment exposure (\<12weeks, \>=12 weeks) as covariates.|ANCOVA|||Lumbar Spine BMD||1.204|-0.226|0.179
72614728|NCT00817063|144759470|SUPERIORITY||Mean Difference (Net)|0.497||||0.089|TWO_SIDED|95.0|-0.077|1.071||The analysis of covariance model includes treatment, age at Baseline, gender, menopausal status of females, baseline BMD score and duration of treatment exposure (\<12weeks, \>=12 weeks) as covariates.|ANCOVA|||Femur BMD||1.071|-0.077|0.089
72614729|NCT01496456|144759474|SUPERIORITY_OR_OTHER|||||||0.002|||||||Regression, Logistic|Ordinal logistic regression, controlled for baseline lesion size and for correlation among pairs of teeth using the GEE method.||||||0.002
72614730|NCT01496456|144759475|SUPERIORITY_OR_OTHER|||||||0.045|||||||Regression, Logistic|Ordinal logistic regression, controlled for correlation among pairs of teeth using the GEE method.||||||0.045
72614731|NCT01496456|144759476|SUPERIORITY_OR_OTHER|||||||0.0077|||||||Discreet Time Survival Analysis|Controlled for correlation among tooth pairs (GEE model).||||||0.0077
72614732|NCT04919161|144759477|SUPERIORITY||||||<|0.0001||||||The a priori threshold for statistical significance was p\<0.05. The p-value reported above was the calculated and resultant P-value for this analysis.|Kruskal-Wallis|Due sample size differences and pairwise nature of the data, a Kruskal-Wallis was conducted.||Null hypothesis for this analysis is that there will be no differences between pre-scores and post-scores across the different treatment arms. Prior to hypothesis testing, datasets were tested for normality using a Shapiro-Wilk test to inform if parametric or non-parametric testing was required.||||<0.0001
72614733|NCT04919161|144759477|SUPERIORITY||||||=|0.0025||||||The a priori threshold for statistical significance was p\<0.05. The p-value reported above was the calculated and resultant P-value for this analysis. The reported P-value is adjusted for multiple comparisons.|Dunn's Multiple Comparison Test|||Null hypothesis for this comparison is that there would be no significant difference in the pre-score measurements between groups.||||=0.0025
72614734|NCT04919161|144759477|SUPERIORITY||||||=|0.0001||||||The a priori threshold for statistical significance was p\<0.05. The p-value reported above was the calculated and resultant P-value for this analysis. The reported P-value is adjusted for multiple comparisons.|Dunn's Multiple Comparison Test|||Null hypothesis for this comparison is that there would be no significant difference in the pre-score measurements between groups.||||=0.0001
72492988|NCT03036293|144514786|SUPERIORITY||Mean Difference (Final Values)|2.56|||<|0.0001|TWO_SIDED|98.33|1.1|3.96|||ANCOVA|Baseline score used as covariate. Yeo-Johnson transformation with λ=1,09 was applied. Statistical inference performed for transformed values.|estimate and CL are backtransformed|Mean score differences (begin-end) were compared||3.96|1.1|<0.0001
72614735|NCT04919161|144759477|SUPERIORITY||||||>|0.9999||||||The a priori threshold for statistical significance was p\<0.05. The p-value reported above was the calculated and resultant P-value for this analysis. The reported P-value is adjusted for multiple comparisons.|Dunn's Multiple Comparison Test|||Null hypothesis for this comparison is that there would be no significant difference in the pre-score measurements between groups.||||>0.9999
72614736|NCT04919161|144759477|SUPERIORITY||||||>|0.9999||||||The a priori threshold for statistical significance was p\<0.05. The p-value reported above was the calculated and resultant P-value for this analysis. The reported P-value is adjusted for multiple comparisons.|Dunn's Multiple Comparison Test|||Null hypothesis for this comparison would be that there would be no significant difference between post-scores of the two treatment groups.||||>0.9999
72614737|NCT04919161|144759478|SUPERIORITY|Prior to analysis, the score change or difference between post-test and pre-test were calculated for each participant as: ScoreChange=(PostTest) - (PreTest). These changes in score were then compared.|||||=|0.3045||||||The a priori threshold for statistical significance was p\<0.05. The p-value reported above was the calculated and resultant P-value for this analysis.|t-test, 2 sided|||Null hypothesis is that there are no differences between groups. Prior to hypothesis testing, datasets were tested for normality using a Shapiro-Wilk test to inform if parametric or non-parametric testing was required.||||=0.3045
72614738|NCT04919161|144759479|SUPERIORITY|Prior to analysis, the score change or difference between post-test and pre-test were calculated for each participant as: PercentScoreChange = (\[(PostTest)-(PreTest)\]/\[PreTest\]) x 100%|||||=|3152||||||The a priori threshold for statistical significance was p\<0.05. The p-value reported above was the calculated and resultant P-value for this analysis.|Two-Tailed Welch t test|Due to unequal standard deviation, a two-tailed Welch's t test was used.||Null hypothesis is that there are no differences between groups. Prior to hypothesis testing, datasets were tested for normality using a Shapiro-Wilk test to inform if parametric or non-parametric testing was required.||||=3152
72614739|NCT04919161|144759480|SUPERIORITY||||||=|0.9568||||||Prior to analysis, the score change between post assessment and pre-assessment was calculated. The threshold for significance was p\<0.05.|t-test, 2 sided|An unpaired T-test was used. Normality and F-test for Variances were conducted and found to be normal.||Null hypothesis is that there are no differences between groups. Prior to hypothesis testing, datasets were tested for normality using a Shapiro-Wilk test to inform if parametric or non-parametric testing was required.||||=0.9568
72614740|NCT04919161|144759481|SUPERIORITY||||||<|0.0001||||||The a priori threshold for statistical significance was p\<0.05. The p-value reported above was the calculated and resultant P-value for this analysis.|Kruskal-Wallis|Due to the pairwise nature and abnormal distribution of the pre- and post-scores, a Kruskal Wallis test was completed.||Null Hypothesis, there would be no difference between the pre-score and post-score of each treatment group. Prior to hypothesis testing, datasets were tested for normality using a Shapiro-Wilk test to inform if parametric or non-parametric testing was required.||||<0.0001
72370757|NCT02785770|144251825|SUPERIORITY_OR_OTHER||LS mean difference|3.74||||0.0036|TWO_SIDED|90.0|1.64|5.85|||Repeated Measures Model|||Moxifloxacin 400 mg versus Placebo, 24 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||5.85|1.64|0.0036
72492989|NCT03036293|144514786|EQUIVALENCE|equivalence limits were prespecified as \[-2.763; 2.763\]|Mean Difference (Net)|0.89||||0.0008|TWO_SIDED|98.33|-0.64|2.33|||ANCOVA|Baseline score used as covariate||Mean score differences (begin-end) were compared||2.33|-0.64|0.0008
72492990|NCT03036293|144514787|SUPERIORITY||Mean Difference (Net)|0.6||||0.08|TWO_SIDED|95.0|-0.08|1.54|||ANCOVA|Baseline score used as covariate||Mean score differences (begin-end) were compared||1.54|-0.08|0.08
72614741|NCT04919161|144759481|SUPERIORITY||||||<|0.0001||||||The a priori threshold for statistical significance was p\<0.05. The p-value reported above was the calculated and resultant P-value for this analysis. The reported P-value is adjusted for multiple comparisons.|Dunn's Multiple Comparison Test|||Null hypothesis for this comparison is that there would be no significant difference in the pre-score measurements between groups.||||<0.0001
72614742|NCT04919161|144759481|SUPERIORITY||||||<|0.0001||||||The a priori threshold for statistical significance was p\<0.05. The p-value reported above was the calculated and resultant P-value for this analysis. The reported P-value is adjusted for multiple comparisons.|Dunn's Multiple Comparison Test|||Null hypothesis for this comparison is that there would be no significant difference in the pre-score measurements between groups.||||<0.0001
72614743|NCT04919161|144759481|SUPERIORITY||||||>|0.9999||||||The a priori threshold for statistical significance was p\<0.05. The p-value reported above was the calculated and resultant P-value for this analysis. The reported P-value is adjusted for multiple comparisons.|Dunn's Multiple Comparison Test|||Null hypothesis for this comparison is that there would be no significant difference in the pre-score measurements between groups.||||>0.9999
72492991|NCT03036293|144514787|SUPERIORITY||Mean Difference (Net)|0.76||||0.044|TWO_SIDED|95.0|0.02|1.66|||ANCOVA|Baseline score used as covariate||Mean score differences (begin-end) were compared||1.66|0.02|0.044
72614744|NCT04919161|144759481|SUPERIORITY||||||>|0.9999||||||The a priori threshold for statistical significance was p\<0.05. The p-value reported above was the calculated and resultant P-value for this analysis. The reported P-value is adjusted for multiple comparisons.|Dunn's Multiple Comparison Test|||Null hypothesis for this comparison is that there would be no significant difference in the pre-score measurements between groups.||||>0.9999
72614745|NCT04919161|144759482|SUPERIORITY||||||<|0.0001||||||The a priori threshold for statistical significance was p\<0.05. The p-value reported above was the calculated and resultant P-value for this analysis.|Kruskal-Wallis|Due to missing measurements and the pairwise nature of the pre- and post-scores, a Kruskal Wallis test was completed.||Null hypothesis is that there are no differences between groups. Prior to hypothesis testing, datasets were tested for normality using a Shapiro-Wilk test to inform if parametric or non-parametric testing was required.||||<0.0001
72492992|NCT03036293|144514788|SUPERIORITY||Mean Difference (Net)|0.69||||0.21|TWO_SIDED|95.0|-0.4|1.78|||ANCOVA|Baseline score used as covariate||Mean score differences (begin-end) were compared||1.78|-0.4|0.21
72492993|NCT03036293|144514788|SUPERIORITY||Mean Difference (Net)|1.19||||0.027|TWO_SIDED|95.0|0.14|2.26|||ANCOVA|Baseline score used as covariate||Mean score differences (begin-end) were compared||2.26|0.14|0.027
72370758|NCT02785770|144251826|SUPERIORITY_OR_OTHER||Least Square (LS) Mean Difference|-0.29||||0.8195|TWO_SIDED|90.0|-2.38|1.8|||Repeated Measures Model|||PF-04447943 25 mg versus Placebo: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||1.80|-2.38|0.8195
72431810|NCT01195675|144375711|NON_INFERIORITY_OR_EQUIVALENCE|Empa vs placebo. Non-confirmatory testing.|Mean Difference (Final Values)|2.16|STANDARD_ERROR_OF_MEAN|1.5|||TWO_SIDED|90.0|-0.34|4.67|||Repeated measures analysis|Based on repeated measured analysis with terms for subject, baseline, period, treatment, time, baseline by time, period by time and treatment by time.|Mean difference = Empa minus placebo|Non-inferiority margin: 10ms||4.67|-0.34|
72492994|NCT03036293|144514789|SUPERIORITY||Odds Ratio (OR)|1.36||||0.065|TWO_SIDED|95.0|0.98|1.89|||Cochran-Mantel-Haenszel||Bigger OR is better|Common OR of event analysis||1.89|0.98|0.065
72370759|NCT02785770|144251826|SUPERIORITY_OR_OTHER||LS Mean Difference|4.54||||0.0004|TWO_SIDED|90.0|2.44|6.64|||Repeated Measures Model|||PF-04447943 100 mg versus Placebo: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||6.64|2.44|0.0004
72370760|NCT02785770|144251827|SUPERIORITY_OR_OTHER||LS mean difference|0.14||||0.9146|TWO_SIDED|90.0|-1.95|2.22|||Repeated Measures Model|||PF-04447943 25 mg versus Placebo: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||2.22|-1.95|0.9146
72370761|NCT02785770|144251827|SUPERIORITY_OR_OTHER||LS mean difference|5.04|||<|0.0001|TWO_SIDED|90.0|2.95|7.14|||Repeated Measures Model|||PF-04447943 100 mg versus Placebo: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||7.14|2.95|<0.0001
72370762|NCT02785770|144251828|SUPERIORITY_OR_OTHER||LS mean difference|1.24||||0.3272|TWO_SIDED|90.0|-0.84|3.33|||Repeated Measures Model|||PF-04447943 25 mg versus Placebo: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||3.33|-0.84|0.3272
72370763|NCT02785770|144251828|SUPERIORITY_OR_OTHER||LS mean difference|4.26||||0.0009|TWO_SIDED|90.0|2.16|6.36|||Repeated Measures Model|||PF-04447943 100 mg versus Placebo: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||6.36|2.16|0.0009
72370764|NCT02785770|144251829|SUPERIORITY_OR_OTHER||LS mean difference|-0.48||||0.7024|TWO_SIDED|90.0|-2.57|1.6|||Repeated Measures Model|||PF-04447943 25 mg versus Placebo: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||1.60|-2.57|0.7024
72370765|NCT02785770|144251829|SUPERIORITY_OR_OTHER||LS mean difference|2.26||||0.0768|TWO_SIDED|90.0|0.16|4.36|||Repeated Measures Model|||PF-04447943 100 mg versus Placebo: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||4.36|0.16|0.0768
72370766|NCT02785770|144251830|SUPERIORITY_OR_OTHER||LS mean difference|-1.97||||0.1201|TWO_SIDED|90.0|-4.06|0.12|||Repeated Measures Model|||PF-04447943 25 mg versus Placebo: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||0.12|-4.06|0.1201
72370767|NCT02785770|144251830|SUPERIORITY_OR_OTHER||LS mean difference|1.21||||0.3424|TWO_SIDED|90.0|-0.89|3.31|||Repeated Measures Model|||PF-04447943 100 mg versus Placebo: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||3.31|-0.89|0.3424
72370768|NCT02785770|144251831|SUPERIORITY_OR_OTHER||LS mean difference|-1.35||||0.287|TWO_SIDED|90.0|-3.44|0.74|||Repeated Measures Model|||PF-04447943 25 mg versus Placebo: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||0.74|-3.44|0.2870
72431811|NCT01195675|144375712|NON_INFERIORITY_OR_EQUIVALENCE|Empa vs placebo. Non-confirmatory testing.|Mean Difference (Final Values)|1.59|STANDARD_ERROR_OF_MEAN|1.16|||TWO_SIDED|90.0|-0.35|3.53|||Repeated measures analysis|Based on repeated measured analysis with terms for subject, baseline, period, treatment, time, baseline by time, period by time and treatment by time.|Mean difference = Empa minus placebo|Non-inferiority margin: 10ms||3.53|-0.35|
72431812|NCT01195675|144375713|NON_INFERIORITY_OR_EQUIVALENCE|Empa vs placebo|Mean Difference (Final Values)|-0.22|STANDARD_ERROR_OF_MEAN|0.69|||TWO_SIDED|90.0|-1.39|0.94|||ANCOVA|Based on ANCOVA with terms for sequence, subjects within sequence, period, treatment and baseline.|Mean difference = Empa minus placebo|Non-inferiority margin: 10ms||0.94|-1.39|
72431813|NCT05153174|144375722|EQUIVALENCE|p \< 0.05 to reject null hypothesis of equivalence||||||0.931|||||||t-test, 2 sided|||||||0.931
72431814|NCT05153174|144375723|EQUIVALENCE|p \< 0.05 to reject null hypothesis of equivalence||||||0.224|||||||t-test, 2 sided|||||||0.224
72431815|NCT01450943|144375725|SUPERIORITY||Odds Ratio (OR)|2.712595||||0.0517|TWO_SIDED|95.0|0.9141|8.4839|||Fisher Exact|||||8.4839|0.9141|0.0517
72370769|NCT02785770|144251831|SUPERIORITY_OR_OTHER||LS mean difference|-0.11||||0.9334|TWO_SIDED|90.0|-2.21|1.99|||Repeated Measures Model|||PF-04447943 100 mg versus Placebo: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||1.99|-2.21|0.9334
72370770|NCT02785770|144251832|SUPERIORITY_OR_OTHER||LS mean difference|-2.16||||0.0893|TWO_SIDED|90.0|-4.24|-0.07|||Repeated Measures Model|||PF-04447943 25 mg versus Placebo: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||-0.07|-4.24|0.0893
72370771|NCT02785770|144251832|SUPERIORITY_OR_OTHER||LS mean difference|-2.61||||0.0412|TWO_SIDED|90.0|-4.71|-0.51|||Repeated Measures Model|||PF-04447943 100 mg versus Placebo: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||-0.51|-4.71|0.0412
72431816|NCT01450943|144375726|SUPERIORITY||Odds Ratio (OR)|0.812339||||0.7974|TWO_SIDED|95.0|0.2543|2.5224|||Fisher Exact|||||2.5224|0.2543|0.7974
72492995|NCT03036293|144514789|SUPERIORITY||Odds Ratio (OR)|1.68||||0.0015|TWO_SIDED|95.0|1.22|2.33|||Cochran-Mantel-Haenszel||Bigger OR is better|Common OR of event analysis||2.33|1.22|0.0015
72370772|NCT02785770|144251833|SUPERIORITY_OR_OTHER||LS mean difference|-1.34||||0.2892|TWO_SIDED|90.0|-3.43|0.74|||Repeated Measures Model|||PF-04447943 25 mg versus Placebo: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||0.74|-3.43|0.2892
72370773|NCT02785770|144251833|SUPERIORITY_OR_OTHER||LS mean difference|-2.78||||0.0294|TWO_SIDED|90.0|-4.88|-0.68|||Repeated Measures Model|||PF-04447943 100 mg versus Placebo: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||-0.68|-4.88|0.0294
72370774|NCT02785770|144251834|SUPERIORITY_OR_OTHER||LS mean difference|1.28||||0.16|TWO_SIDED|90.0|-0.22|2.78|||Repeated Measures Model|||PF-04447943 25 mg versus Placebo, 0.5 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||2.78|-0.22|0.1600
72370775|NCT02785770|144251834|SUPERIORITY_OR_OTHER||LS mean difference|2.38||||0.0092|TWO_SIDED|90.0|0.88|3.87|||Repeated Measures Model|||PF-04447943 25 mg versus Placebo, 1 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||3.87|0.88|0.0092
72370776|NCT02785770|144251834|SUPERIORITY_OR_OTHER||LS mean difference|0.91||||0.3174|TWO_SIDED|90.0|-0.59|2.41|||Repeated Measures Model|||PF-04447943 25 mg versus Placebo, 2 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||2.41|-0.59|0.3174
72370777|NCT02785770|144251834|SUPERIORITY_OR_OTHER||LS mean difference|-0.31||||0.7344|TWO_SIDED|90.0|-1.81|1.19|||Repeated Measures Model|||PF-04447943 25 mg versus Placebo, 3 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||1.19|-1.81|0.7344
72431817|NCT05176353|144375728|SUPERIORITY|||||||0.86|||||||Z-score test for person-time rates|||||||0.86
72492996|NCT03036293|144514789|SUPERIORITY|||||||0.7|||||||Fisher Exact|||Week 4 frequencies comparison||||0.7
72370778|NCT02785770|144251834|SUPERIORITY_OR_OTHER||LS mean difference|0.49||||0.5881|TWO_SIDED|90.0|-1.0|1.99|||Repeated Measures Model|||PF-04447943 25 mg versus Placebo, 4 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||1.99|-1.00|0.5881
72370779|NCT02785770|144251834|SUPERIORITY_OR_OTHER||LS mean difference|-0.82||||0.368|TWO_SIDED|90.0|-2.32|0.68|||Repeated Measures Model|||PF-04447943 25 mg versus Placebo, 8 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||0.68|-2.32|0.3680
72492997|NCT03036293|144514789|SUPERIORITY|||||||1|||||||Fisher Exact|||Week 8 frequencies comparison||||1
72370780|NCT02785770|144251834|SUPERIORITY_OR_OTHER||LS mean difference|-0.73||||0.42|TWO_SIDED|90.0|-2.23|0.76|||Repeated Measures Model|||PF-04447943 25 mg versus Placebo, 12 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||0.76|-2.23|0.4200
72370781|NCT02785770|144251834|SUPERIORITY_OR_OTHER||LS mean difference|-3.03||||0.0009|TWO_SIDED|90.0|-4.53|-1.53|||Repeated Measures Model|||PF-04447943 25 mg versus Placebo, 24 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||-1.53|-4.53|0.0009
72370782|NCT02785770|144251834|SUPERIORITY_OR_OTHER||LS mean difference|4.46|||<|0.0001|TWO_SIDED|90.0|2.96|5.97|||Repeated Measures Model|||PF-04447943 100 mg versus Placebo, 0.5 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||5.97|2.96|< 0.0001
72370783|NCT02785770|144251834|SUPERIORITY_OR_OTHER||LS mean difference|5.83|||<|0.0001|TWO_SIDED|90.0|4.32|7.33|||Repeated Measures Model|||PF-04447943 100 mg versus Placebo, 1 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||7.33|4.32|< 0.0001
72370784|NCT02785770|144251834|SUPERIORITY_OR_OTHER||LS mean difference|4.09|||<|0.0001|TWO_SIDED|90.0|2.58|5.59|||Repeated Measures Model|||PF-04447943 100 mg versus Placebo, 2 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||5.59|2.58|< 0.0001
72370785|NCT02785770|144251834|SUPERIORITY_OR_OTHER||LS mean difference|2.53||||0.0059|TWO_SIDED|90.0|1.02|4.03|||Repeated Measures Model|||PF-04447943 100 mg versus Placebo, 3 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||4.03|1.02|0.0059
72370786|NCT02785770|144251834|SUPERIORITY_OR_OTHER||LS mean difference|2.5||||0.0063|TWO_SIDED|90.0|1.0|4.01|||Repeated Measures Model|||PF-04447943 100 mg versus Placebo, 4 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||4.01|1.00|0.0063
72370787|NCT02785770|144251834|SUPERIORITY_OR_OTHER||LS mean difference|1.45||||0.1138|TWO_SIDED|90.0|-0.06|2.95|||Repeated Measures Model|||PF-04447943 100 mg versus Placebo, 8 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||2.95|-0.06|0.1138
72431818|NCT05176353|144375729|SUPERIORITY|||||||0.05|||||||Z-score test for person-time rates|||||||0.05
72553918|NCT03653507|144639951|SUPERIORITY||Hazard Ratio (HR)|0.689||||0.0005|TWO_SIDED|95.0|0.552|0.86|||Log Rank||Log-rank test stratified by:\* Region (Asia vs Non-Asia), \* Number of organs with metastatic sites (0 to 2 vs \>= 3), \* Prior gastrectomy (Yes or No)|||0.860|0.552|0.0005
72431819|NCT05176353|144375730|SUPERIORITY|||||||0.59|||||||Kruskal-Wallis|||||||0.59
72492998|NCT03036293|144514789|SUPERIORITY|||||||0.01|||||||Fisher Exact|||Week 12 frequencies comparison||||0.01
72492999|NCT03036293|144514789|SUPERIORITY|||||||0.57|||||||Fisher Exact|||Week 4 frequencies comparison||||0.57
72493000|NCT03036293|144514789|SUPERIORITY|||||||0.25|||||||Fisher Exact|||Week 8 frequencies comparison||||0.25
72493001|NCT03036293|144514789|SUPERIORITY|||||||0.001|||||||Fisher Exact|||Week 12 frequencies comparison||||0.001
72614746|NCT04919161|144759482|SUPERIORITY||||||<|0.0001||||||The a priori threshold for statistical significance was p\<0.05. The p-value reported above was the calculated and resultant P-value for this analysis.|Dunn's Multiple Comparison Test|||||||<0.0001
72493002|NCT03036293|144514790|SUPERIORITY||Odds Ratio (OR)|0.88||||0.46|TWO_SIDED|95.0|0.64|1.23|||Cochran-Mantel-Haenszel||Bigger OR is better|Common OR of event analysis||1.23|0.64|0.46
72614747|NCT04919161|144759482|SUPERIORITY||||||<|0.0001||||||The a priori threshold for statistical significance was p\<0.05. The p-value reported above was the calculated and resultant P-value for this analysis.|Dunn's Multiple Comparison Test|||||||<0.0001
72614748|NCT04919161|144759482|SUPERIORITY||||||>|0.9999||||||The a priori threshold for statistical significance was p\<0.05. The p-value reported above was the calculated and resultant P-value for this analysis.|Dunn's Multiple Comparison Test|||||||>0.9999
72614749|NCT04919161|144759482|SUPERIORITY||||||>|0.9999||||||The a priori threshold for statistical significance was p\<0.05. The p-value reported above was the calculated and resultant P-value for this analysis.|Dunn's Multiple Comparison Test|||||||>0.9999
72614750|NCT04919161|144759483|SUPERIORITY||||||<|0.0001||||||The threshold for statistical significance was p\<0.05.|Kruskal-Wallis|Due to the missing measurement and the pairwise nature of the perturbation levels between participants, a Kruskal Wallis test was completed.||Null hypothesis is there are no differences between groups. Prior to hypothesis testing, normality testing was conducted using a Shapiro-Wild test to inform if parametric or non-parametric testing was required.||||<0.0001
72614751|NCT04919161|144759483|SUPERIORITY||||||>|0.9999||||||Reported p-value is adjusted for multiple comparisons. The a priori threshold for statistical significance was established as p\<0.05.|Dunn's Multiple Comparison Test|||Null hypothesis for any comparisons would be that there is no significant mean perturbation level between sessions.|The p-value reported above was the result for 15 comparisons of the recorded perturbation levels in sessions: 1 vs 2, 2 vs 3, 3 vs 4, 3 vs 5, 3 vs 6, 4 vs 5, 4 vs 6, 4 vs 7, 4 vs 8, 5 vs 6, 5 vs 7, 5 vs 8, 6 vs 7, 6 vs 8, and 7 vs 8.|||>0.9999
72614752|NCT04919161|144759483|SUPERIORITY||||||=|0.0629|||||||Dunn's Multiple Comparison Test|||||||=0.0629
72614753|NCT04919161|144759483|SUPERIORITY||||||=|0.0069|||||||Dunn's Multiple Comparison Test|||||||=0.0069
72614754|NCT04919161|144759483|SUPERIORITY||||||=|0.0003|||||||Dunn's Multiple Comparison Test|||||||=0.0003
72614755|NCT04919161|144759483|SUPERIORITY||||||<|0.0001|||||||Dunn's Multiple Comparison Test|||||||<0.0001
72614756|NCT04919161|144759483|SUPERIORITY||||||<|0.0001|||||||Dunn's Multiple Comparison Test|||||||<0.0001
72614757|NCT04919161|144759483|SUPERIORITY||||||<|0.0001|||||||Dunn's Multiple Comparison Test|||||||<0.0001
72370788|NCT02785770|144251834|SUPERIORITY_OR_OTHER||LS mean difference|-0.36||||0.6976|TWO_SIDED|90.0|-1.86|1.15|||Repeated Measures Model|||PF-04447943 100 mg versus Placebo, 12 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||1.15|-1.86|0.6976
72431820|NCT05176353|144375731|SUPERIORITY||||||<|0.01|||||||Z-score test for person-time rates|||||||<0.01
72614758|NCT04919161|144759483|SUPERIORITY||||||=|0.6497|||||||Dunn's Multiple Comparison Test|||||||=0.6497
72614759|NCT04919161|144759483|SUPERIORITY||||||=|0.0743|||||||Dunn's Multiple Comparison Test|||||||=0.0743
72614760|NCT04919161|144759483|SUPERIORITY||||||=|0.0198|||||||Dunn's Multiple Comparison Test|||||||=0.0198
72614761|NCT04919161|144759483|SUPERIORITY||||||=|0.0017|||||||Dunn's Multiple Comparison Test|||||||=0.0017
72614762|NCT04919161|144759483|SUPERIORITY||||||=|0.0006|||||||Dunn's Multiple Comparison Test|||||||=0.0006
72614763|NCT04919161|144759483|SUPERIORITY||||||=|0.5297|||||||Dunn's Multiple Comparison Test|||||||=0.5297
72614764|NCT04919161|144759483|SUPERIORITY||||||=|0.2595|||||||Dunn's Multiple Comparison Test|||||||=0.2595
72614765|NCT04919161|144759484|OTHER|This is a descriptive analysis.|Odds Ratio (OR)|2.6|||=|0.3898|TWO_SIDED|95.0|0.4671|15.3||Threshold for statistical significance was p\<0.05|Fisher Exact|||Null hypothesis was that there would be no difference in the proportion of males and females between treatment arms.||15.300|0.4671|=0.3898
72614766|NCT02489773|144759485|OTHER|Calculate the pearson correlation within whole subjects (across Group 1 and Group 2)|pearson correlation coefficient|0.6342|||||TWO_SIDED|||||||||||||
72614767|NCT02489773|144759485|OTHER|Diffenrence between Pearson correlations within whole subjects (accross Group 1 and Group 2) and PG, 0.8.|Difference with PG 0.8|-0.1658|||>|0.9999|TWO_SIDED|95.0|-0.2204|-0.1113|||t-test, 2 sided|||||-0.1113|-0.2204|>0.9999
72614768|NCT02489773|144759486|OTHER|The difference in Spearman correlation coefficient between GA and MBG vs HbA1c and MBG in the first 3-month period in Group 1.|Difference in correlation coefficients|0.249|||<|0.0001|TWO_SIDED|95.0|0.13|0.364|||t-test, 2 sided|||||0.364|0.130|<0.0001
72614769|NCT02489773|144759487|OTHER|The difference in Kendall correlation coefficient between GA and MBG vs HbA1c and MBG in the first 3-month period in Group 1.|Difference in correlation coefficient|0.181|||<|0.0001|TWO_SIDED|95.0|0.096|0.265|||t-test, 2 sided|||||0.265|0.096|<0.0001
72614770|NCT00712920|144759488|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9||||0.03||95.0|-1.7|-0.1|||ANCOVA|ANCOVA is being used due to a covariate being included in the model. The covariate is baseline TNSS score.||||-0.10|-1.70|0.03
72614771|NCT00712920|144759488|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7||||0.08||95.0|-1.5|0.1|||ANCOVA|ANCOVA is being used due to a covariate being included in the model. The covariate is baseline TNSS score.||||0.1|-1.5|0.08
72614772|NCT00712920|144759489|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6419|STANDARD_DEVIATION|0.3924||0.102||95.0|-1.41|0.13|||ANCOVA|ANCOVA is being used due to a covariate being included in the model. The covariate is baseline TNSS score.||||0.13|-1.41|0.102
72614773|NCT00712920|144759489|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7925|STANDARD_DEVIATION|0.3935||0.044||95.0|-1.56|-0.02|||ANCOVA|ANCOVA is being used due to a covariate being included in the model. The covariate is baseline TNSS score.||||-0.02|-1.56|0.044
72614774|NCT00712920|144759490|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4394|STANDARD_DEVIATION|0.3631||0.226||95.0|-1.15|0.27|||ANCOVA|ANCOVA is being used due to a covariate being included in the model. The covariate is baseline TNSS score.||Change in baseline to Day 28||0.27|-1.15|0.226
72614775|NCT00712920|144759490|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.1252|STANDARD_DEVIATION|0.3649||0.002||95.0|-1.84|-0.41|||ANCOVA|ANCOVA is being used due to a covariate being included in the model. The covariate is baseline TNSS score.||Change in baseline to Day 28||-0.41|-1.84|0.002
72370789|NCT02785770|144251834|SUPERIORITY_OR_OTHER||LS mean difference|-2.12||||0.0208|TWO_SIDED|90.0|-3.62|-0.61|||Repeated Measures Model|||PF-04447943 100 mg versus Placebo, 24 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||-0.61|-3.62|0.0208
72370790|NCT02785770|144251835|SUPERIORITY_OR_OTHER||LS mean difference|-0.64||||0.576|TWO_SIDED|90.0|-2.53|1.25|||Repeated Measures Model|||PF-04447943 25 mg versus Placebo, 0.5 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||1.25|-2.53|0.5760
72370791|NCT02785770|144251835|SUPERIORITY_OR_OTHER||LS mean difference|-0.94||||0.4126|TWO_SIDED|90.0|-2.83|0.95|||Repeated Measures Model|||PF-04447943 25 mg versus Placebo, 1 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||0.95|-2.83|0.4126
72370792|NCT02785770|144251835|SUPERIORITY_OR_OTHER||LS mean difference|-1.17||||0.3085|TWO_SIDED|90.0|-3.06|0.72|||Repeated Measures Model|||PF-04447943 25 mg versus Placebo, 2 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||0.72|-3.06|0.3085
72370793|NCT02785770|144251835|SUPERIORITY_OR_OTHER||LS mean difference|-0.99||||0.3889|TWO_SIDED|90.0|-2.88|0.9|||Repeated Measures Model|||PF-04447943 25 mg versus Placebo, 3 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||0.90|-2.88|0.3889
72370794|NCT02785770|144251835|SUPERIORITY_OR_OTHER||LS mean difference|-0.57||||0.6192|TWO_SIDED|90.0|-2.46|1.32|||Repeated Measures Model|||PF-04447943 25 mg versus Placebo, 4 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||1.32|-2.46|0.6192
72370795|NCT02785770|144251835|SUPERIORITY_OR_OTHER||LS mean difference|-2.45||||0.0332|TWO_SIDED|90.0|-4.34|-0.56|||Repeated Measures Model|||PF-04447943 25 mg versus Placebo, 8 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||-0.56|-4.34|0.0332
72370796|NCT02785770|144251835|SUPERIORITY_OR_OTHER||LS mean difference|-0.41||||0.7224|TWO_SIDED|90.0|-2.3|1.48|||Repeated Measures Model|||PF-04447943 25 mg versus Placebo, 12 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||1.48|-2.30|0.7224
72431821|NCT05176353|144375732|SUPERIORITY|||||||0.2|||||||Z-score test for person-time rates|||||||0.20
72493003|NCT03036293|144514790|SUPERIORITY||Odds Ratio (OR)|1.27||||0.17|TWO_SIDED|95.0|0.9|1.79|||Cochran-Mantel-Haenszel||Bigger OR is better|Common OR of event analysis||1.79|0.9|0.17
72431822|NCT05176353|144375733|SUPERIORITY|||||||0.03|||||||Z-score test for person-time rates|||||||0.03
72431823|NCT05176353|144375734|SUPERIORITY||||||<|0.01|||||||Z-score test for person-time rates|||||||<0.01
72493004|NCT03036293|144514790|SUPERIORITY|||||||0.38|||||||Fisher Exact|||Week 4 frequencies comparison||||0.38
72370797|NCT02785770|144251835|SUPERIORITY_OR_OTHER||LS mean difference|0.52||||0.6507|TWO_SIDED|90.0|-1.37|2.41|||Repeated Measures Model|||PF-04447943 25 mg versus Placebo, 24 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||2.41|-1.37|0.6507
72370798|NCT02785770|144251835|SUPERIORITY_OR_OTHER||LS mean difference|-1.72||||0.1366|TWO_SIDED|90.0|-3.62|0.18|||Repeated Measures Model|||PF-04447943 100 mg versus Placebo, 0.5 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||0.18|-3.62|0.1366
72370799|NCT02785770|144251835|SUPERIORITY_OR_OTHER||LS mean difference|-2.81||||0.0153|TWO_SIDED|90.0|-4.71|-0.91|||Repeated Measures Model|||PF-04447943 100 mg versus Placebo, 1 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||-0.91|-4.71|0.0153
72370800|NCT02785770|144251835|SUPERIORITY_OR_OTHER||LS mean difference|-1.88||||0.104|TWO_SIDED|90.0|-3.78|0.02|||Repeated Measures Model|||PF-04447943 100 mg versus Placebo, 2 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||0.02|-3.78|0.1040
72431824|NCT05176353|144375735|SUPERIORITY|||||||0.05|||||||Chi-squared|||||||.05
72431825|NCT03815916|144375741|SUPERIORITY||Mean Difference (Final Values)|0.3865||||0.1077|TWO_SIDED||||||t-test, 2 sided|||The primary efficacy endpoint is the mean change in the average NAD+/NADH brain ratio from baseline to Week 12 using a partial volume coil 31P-MRS data on the Per Protocol Treatment Population. A paired t-test will be used to analyze the mean change from baseline.||||0.1077
72431826|NCT03566680|144375812|EQUIVALENCE||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
72431827|NCT03566680|144375813|EQUIVALENCE||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
72431828|NCT03566680|144375814|EQUIVALENCE||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
72431829|NCT03566680|144375815|EQUIVALENCE|||||||0.73|||||||t-test, 2 sided|||||||0.73
72431830|NCT03566680|144375816|EQUIVALENCE|||||||0.08|||||||t-test, 2 sided|||||||0.08
72431831|NCT03566680|144375817|EQUIVALENCE|||||||0.72|||||||t-test, 2 sided|||||||0.72
72431832|NCT02374957|144375823|SUPERIORITY|||||||0.26|||||||t-test, 2 sided|||"Null hypothesis: six-week change in EQ5D sum score is the same between the two arms.~Alternate hypothesis: one arm experiences more change in EQ5D than the other over initial six weeks (two-sided test)."||||0.26
72431833|NCT02374957|144375824|SUPERIORITY|||||||0.17|||||||t-test, 2 sided|||"Null hypothesis: three-month change in EQ5D sum score is the same between the two arms.~Alternate hypothesis: one arm experiences more change in EQ5D than the other over three months (two-sided test)."||||0.17
72493005|NCT03036293|144514790|SUPERIORITY|||||||0.67|||||||Fisher Exact|||Week 8 frequencies comparison||||0.67
72493006|NCT03036293|144514790|SUPERIORITY|||||||0.85|||||||Fisher Exact|||Week 12 frequencies comparison||||0.85
72493007|NCT03036293|144514790|SUPERIORITY|||||||0.71|||||||Fisher Exact|||Week 4 frequencies comparison||||0.71
72493008|NCT03036293|144514790|SUPERIORITY|||||||0.29|||||||Fisher Exact|||Week 8 frequencies comparison||||0.29
72431834|NCT02374957|144375825|SUPERIORITY|||||||0.027|||||||t-test, 2 sided|||"Null hypothesis: six-week change in EQ5D visual analog score is the same between the two arms.~Alternate hypothesis: one arm experiences more change in EQ5D visual analog score than the other over initial six weeks (two-sided test)."||||0.027
72431835|NCT02374957|144375826|SUPERIORITY|||||||0.014|||||||t-test, 2 sided|||"Null hypothesis: three-month change in EQ5D visual analog score is the same between the two arms.~Alternate hypothesis: one arm experiences more change in EQ5D visual analog score than the other over three months (two-sided test)."||||0.014
72431836|NCT02374957|144375827|SUPERIORITY|||||||0.82|||||||t-test, 2 sided|||"Null hypothesis: six-week change in EACH Q sum score is the same between the two arms.~Alternate hypothesis: one arm experiences more change in EACH Q sum score than the other over initial six weeks (two-sided test)."||||0.82
72431837|NCT02374957|144375828|SUPERIORITY|||||||0.61|||||||t-test, 2 sided|||"Null hypothesis: three-month change in EACH Q sum score is the same between the two arms.~Alternate hypothesis: one arm experiences more change in EACH Q sum score than the other over three months (two-sided test)."||||0.61
72614776|NCT00712920|144759491|SUPERIORITY_OR_OTHER|||||||0.292||95.0|||||ANCOVA|ANCOVA was used as a model containing treatment group and site as fixed effects with the baseline value used as covariate||||||0.292
72614777|NCT00712920|144759491|SUPERIORITY_OR_OTHER|||||||0.04||95.0|||||ANCOVA|ANCOVA was used as a model containing treatment group and site as fixed effects with the baseline value used as covariate||||||0.040
72614778|NCT02111980|144759504|SUPERIORITY_OR_OTHER_LEGACY|||||||1|||||||t-test, 2 sided|||||||1.0
72614779|NCT01922011|144759514|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was concluded if the lower bound of the 2-sided 95% CI is greater than -15%|Common Difference|-6.1||||0.421|TWO_SIDED|95.0|-19.4|7.4|||Wald||Daptomycin - Comparator|95% confidence interval of the common difference was based on stratified Newcombe confidence interval (CI) with minimum risk weights, with age cohort as the stratification factor.||7.4|-19.4|0.421
72614780|NCT01922011|144759515|SUPERIORITY_OR_OTHER||Common difference|-7.1||||0.467|TWO_SIDED|95.0|-21.6|7.9|||Wald||95% confidence interval of the common difference ( Daptomycin minus Vancomycin or Nafcillin) is based on stratified Newcombe confidence interval (CI) with minimum risk weights, with age cohort as the stratification factor.|||7.9|-21.6|0.467
72614781|NCT01922011|144759516|SUPERIORITY_OR_OTHER||Common difference|-6.2||||0.313|TWO_SIDED|95.0|-17.5|5.0|||Wald||95% confidence interval of the common difference ( Daptomycin minus Vancomycin or Nafcillin) is based on stratified Newcombe confidence interval (CI) with minimum risk weights, with age cohort as the stratification factor.|At EOIV visit||5.0|-17.5|0.313
72614782|NCT01922011|144759516|SUPERIORITY_OR_OTHER||Common difference|-7.9||||0.239|TWO_SIDED|95.0|-19.8|4.0|||Wald||95% confidence interval of the common difference ( Daptomycin minus Vancomycin or Nafcillin) is based on stratified Newcombe confidence interval (CI) with minimum risk weights, with age cohort as the stratification factor.|At EOT visit||4.0|-19.8|0.239
72614783|NCT01922011|144759516|SUPERIORITY_OR_OTHER||Common difference|-6.7||||0.37|TWO_SIDED|95.0|-19.1|5.8|||Wald||95% confidence interval of the common difference ( Daptomycin minus Vancomycin or Nafcillin) is based on stratified Newcombe confidence interval (CI) with minimum risk weights, with age cohort as the stratification factor.|At TOC visit||5.8|-19.1|0.370
72614784|NCT01922011|144759517|SUPERIORITY_OR_OTHER||Common difference|-10.5||||0.23|TWO_SIDED|95.0|-26.3|5.4|||Wald||95% confidence interval of the common difference ( Daptomycin minus Vancomycin or Nafcillin) is based on stratified Newcombe confidence interval (CI) with minimum risk weights, with age cohort as the stratification factor.|Overall Baseline Infecting Pathogen||5.4|-26.3|0.230
72614785|NCT01922011|144759517|SUPERIORITY_OR_OTHER||Common difference|-12.3||||0.164|TWO_SIDED|95.0|-28.5|4.4|||Wald||95% confidence interval of the common difference ( Daptomycin minus Vancomycin or Nafcillin) is based on stratified Newcombe confidence interval (CI) with minimum risk weights, with age cohort as the stratification factor.|SA||4.4|-28.5|0.164
72614786|NCT01922011|144759517|SUPERIORITY_OR_OTHER||Common difference|-15.5||||0.043|TWO_SIDED|95.0|-31.2|1.1|||Wald||95% confidence interval of the common difference ( Daptomycin minus Vancomycin or Nafcillin) is based on stratified Newcombe confidence interval (CI) with minimum risk weights, with age cohort as the stratification factor.|MSSA||1.1|-31.2|0.043
72614787|NCT01922011|144759517|SUPERIORITY_OR_OTHER|||||||0.45|||||||Wald|||MRSA||||0.450
72553919|NCT03653507|144639952|SUPERIORITY||Hazard Ratio (HR)|0.763||||0.0047|TWO_SIDED|95.0|0.622|0.936|||Log Rank||Log-rank test stratified by:\* Region (Asia vs Non-Asia), \* Number of organs with metastatic sites (0 to 2 vs \>= 3), \* Prior gastrectomy (Yes or No)|||0.936|0.622|0.0047
72370801|NCT02785770|144251835|SUPERIORITY_OR_OTHER||LS mean difference|-1.51||||0.1924|TWO_SIDED|90.0|-3.41|0.4|||Repeated Measures Model|||PF-04447943 100 mg versus Placebo, 3 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||0.40|-3.41|0.1924
72431838|NCT02374957|144375829|SUPERIORITY|||||||0.26|||||||Log Rank|||"Null hypothesis: time to patency-failure (graft occlusion) is the same between treatment arms.~Alternate hypothesis: one arm differs from the other in durability of graft patency (two-sided test)."||||0.26
72493009|NCT03036293|144514790|SUPERIORITY|||||||0.007|||||||Fisher Exact|||Week 12 frequencies comparison||||0.007
72614788|NCT01922011|144759517|SUPERIORITY_OR_OTHER|||||||0.28|||||||Wald|||Other Pathogen||||0.280
72614789|NCT01922011|144759518|SUPERIORITY_OR_OTHER||Common difference|-6.3||||0.272|TWO_SIDED|95.0|-18.2|5.5|||Wald||95% confidence interval of the common difference ( Daptomycin minus Vancomycin or Nafcillin) is based on stratified Newcombe confidence interval (CI) with minimum risk weights, with age cohort as the stratification factor.|EOT||5.5|-18.2|0.272
72614790|NCT01922011|144759518|SUPERIORITY_OR_OTHER||Common difference|-4.8||||0.48|TWO_SIDED|95.0|-17.6|7.9|||Wald||95% confidence interval of the common difference ( Daptomycin minus Vancomycin or Nafcillin) is based on stratified Newcombe confidence interval (CI) with minimum risk weights, with age cohort as the stratification factor.|TOC||7.9|-17.6|0.480
72614791|NCT01922011|144759519|SUPERIORITY_OR_OTHER||Common difference|-10.1|||||TWO_SIDED|95.0|-24.8|4.2|||||95% confidence interval of the common difference ( Daptomycin minus Vancomycin or Nafcillin) is based on stratified Newcombe confidence interval (CI) with minimum risk weights, with age cohort as the stratification factor.|Overall Baseline Infecting Pathogen||4.2|-24.8|
72370802|NCT02785770|144251835|SUPERIORITY_OR_OTHER||LS mean difference|-1.94||||0.0928|TWO_SIDED|90.0|-3.84|-0.04|||Repeated Measures Model|||PF-04447943 100 mg versus Placebo, 4 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||-0.04|-3.84|0.0928
72370803|NCT02785770|144251835|SUPERIORITY_OR_OTHER||LS mean difference|-2.06||||0.0745|TWO_SIDED|90.0|-3.96|-0.16|||Repeated Measures Model|||PF-04447943 100 mg versus Placebo, 8 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||-0.16|-3.96|0.0745
72370804|NCT02785770|144251835|SUPERIORITY_OR_OTHER||LS mean difference|-1.01||||0.3836|TWO_SIDED|90.0|-2.91|0.9|||Repeated Measures Model|||PF-04447943 100 mg versus Placebo, 12 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||0.90|-2.91|0.3836
72370805|NCT02785770|144251835|SUPERIORITY_OR_OTHER||LS mean difference|-2.07||||0.0734|TWO_SIDED|90.0|-3.97|-0.17|||Repeated Measures Model|||PF-04447943 100 mg versus Placebo, 24 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||-0.17|-3.97|0.0734
72370806|NCT02785770|144251836|SUPERIORITY_OR_OTHER||LS mean difference|0.8||||0.2588|TWO_SIDED|90.0|-0.36|1.96|||Repeated Measures Model|||PF-04447943 25 mg versus Placebo, 0.5 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||1.96|-0.36|0.2588
72370807|NCT02785770|144251836|SUPERIORITY_OR_OTHER||LS mean difference|0.14||||0.8465|TWO_SIDED|90.0|-1.03|1.3|||Repeated Measures Model|||PF-04447943 25 mg versus Placebo, 1 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||1.30|-1.03|0.8465
72431839|NCT05349084|144375841|EQUIVALENCE|A Fisher's exact test was performed to determine the association between coronary artery stenosis and PET myocardial blood flow (MBF) values during stress. The following myocardial segments were analyzed: left anterior descending (LAD), left circumflex (LCx), and right coronary artery (RCA). Coronary arteries were categorized as coronary arteries with a diameter stenosis ≥50% or \<50%. The MBF values during stress were categorized as normal or abnormal. Normal MBF is defined as \>1.8 mL/g/min.||||||0.2522||||||The threshold for statistical significance was p = 0.05.|Fisher Exact|||||||0.2522
72431840|NCT05349084|144375842|OTHER|A Pearson's Correlation test was performed between PET MFR during stress and CT-FFR by territory.||||||0.028||||||The threshold for statistical significance was p = 0.05.|Pearson's correlation test|A Pearson's Correlation test was performed between PET MFR during stress and CT-FFR by territory.||||||0.028
72370808|NCT02785770|144251836|SUPERIORITY_OR_OTHER||LS mean difference|1.02||||0.1502|TWO_SIDED|90.0|-0.15|2.18|||Repeated Measures Model|||PF-04447943 25 mg versus Placebo, 2 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||2.18|-0.15|0.1502
72370809|NCT02785770|144251836|SUPERIORITY_OR_OTHER||LS mean difference|-0.03||||0.97|TWO_SIDED|90.0|-1.19|1.14|||Repeated Measures Model|||PF-04447943 25 mg versus Placebo, 3 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||1.14|-1.19|0.9700
72370810|NCT02785770|144251836|SUPERIORITY_OR_OTHER||LS mean difference|-1.18||||0.0947|TWO_SIDED|90.0|-2.34|-0.02|||Repeated Measures Model|||PF-04447943 25 mg versus Placebo, 4 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||-0.02|-2.34|0.0947
72370811|NCT02785770|144251836|SUPERIORITY_OR_OTHER||LS mean difference|0.2||||0.7759|TWO_SIDED|90.0|-0.96|1.36|||Repeated Measures Model|||PF-04447943 25 mg versus Placebo, 8 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||1.36|-0.96|0.7759
72370812|NCT02785770|144251836|SUPERIORITY_OR_OTHER||LS mean difference|0.03||||0.9649|TWO_SIDED|90.0|-1.13|1.19|||Repeated Measures Model|||PF-04447943 25 mg versus Placebo, 12 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||1.19|-1.13|0.9649
72370813|NCT02785770|144251836|SUPERIORITY_OR_OTHER||LS mean difference|0.09||||0.9034|TWO_SIDED|90.0|-1.08|1.25|||Repeated Measures Model|||PF-04447943 25 mg versus Placebo, 24 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||1.25|-1.08|0.9034
72370814|NCT02785770|144251836|SUPERIORITY_OR_OTHER||LS mean difference|-0.68||||0.3391|TWO_SIDED|90.0|-1.85|0.49|||Repeated Measures Model|||PF-04447943 100 mg versus Placebo, 0.5 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||0.49|-1.85|0.3391
72370815|NCT02785770|144251836|SUPERIORITY_OR_OTHER||LS mean difference|-1.19||||0.0948|TWO_SIDED|90.0|-2.35|-0.02|||Repeated Measures Model|||PF-04447943 100 mg versus Placebo, 1 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||-0.02|-2.35|0.0948
72370816|NCT02785770|144251836|SUPERIORITY_OR_OTHER||LS mean difference|-0.74||||0.2959|TWO_SIDED|90.0|-1.91|0.43|||Repeated Measures Model|||PF-04447943 100 mg versus Placebo, 2 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||0.43|-1.91|0.2959
72370817|NCT02785770|144251836|SUPERIORITY_OR_OTHER||LS mean difference|-0.07||||0.9161|TWO_SIDED|90.0|-1.24|1.09|||Repeated Measures Model|||PF-04447943 100 mg versus Placebo, 3 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||1.09|-1.24|0.9161
72431841|NCT01072929|144375868|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.8||||0.0097|TWO_SIDED|95.0|-6.58|-0.92||All statistical tests were 2-tailed at the 0.05 level of significance.|mixed-model repeated measures (MMRM)|Treatment, visit, treatment-by-visit interaction, concurrent mood-stabilizing medication, and region of the world used as fixed factors.||||-0.92|-6.58|0.0097
72370818|NCT02785770|144251836|SUPERIORITY_OR_OTHER||LS mean difference|-2.07||||0.0036|TWO_SIDED|90.0|-3.24|-0.91|||Repeated Measures Model|||PF-04447943 100 mg versus Placebo, 4 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||-0.91|-3.24|0.0036
72370819|NCT02785770|144251836|SUPERIORITY_OR_OTHER||LS mean difference|-0.73||||0.3063|TWO_SIDED|90.0|-1.89|0.44|||Repeated Measures Model|||PF-04447943 100 mg versus Placebo, 8 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||0.44|-1.89|0.3063
72370820|NCT02785770|144251836|SUPERIORITY_OR_OTHER||LS mean difference|-0.49||||0.4918|TWO_SIDED|90.0|-1.65|0.68|||Repeated Measures Model|||PF-04447943 100 mg versus Placebo, 12 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||0.68|-1.65|0.4918
72370821|NCT02785770|144251836|SUPERIORITY_OR_OTHER||LS mean difference|-0.61||||0.3862|TWO_SIDED|90.0|-1.78|0.55|||Repeated Measures Model|||PF-04447943 100 mg versus Placebo, 24 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||0.55|-1.78|0.3862
72370822|NCT04518995|144251845|SUPERIORITY||Risk Difference (RD)|0.28|STANDARD_ERROR_OF_MEAN|0.026|<|0.0001|TWO_SIDED|95.0|0.23|0.33||P-value was calculated by Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||||0.33|0.23|<0.0001
72370823|NCT04518995|144251845|SUPERIORITY||Risk Difference (RD)|0.39|STANDARD_ERROR_OF_MEAN|0.034|<|0.0001|TWO_SIDED|95.0|0.32|0.46||P-value was calculated by Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||||0.46|0.32|<0.0001
72370824|NCT04518995|144251846|SUPERIORITY||Risk Difference (RD)|0.25|STANDARD_ERROR_OF_MEAN|0.038|<|0.0001|TWO_SIDED|95.0|0.17|0.32||P-value was calculated by Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||Week 12||0.32|0.17|<0.0001
72431842|NCT01072929|144375868|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.9||||0.0385|TWO_SIDED|95.0|-5.71|-0.16||All statistical tests were 2-tailed at the 0.05 level of significance.|mixed-model repeated measures (MMRM)|Treatment, visit, treatment-by-visit interaction, concurrent mood-stabilizing medication, and region of the world used as fixed factors.||||-0.16|-5.71|0.0385
72370825|NCT04518995|144251846|SUPERIORITY||Risk Difference (RD)|0.35|STANDARD_ERROR_OF_MEAN|0.044|<|0.0001|TWO_SIDED|95.0|0.26|0.43||P-value was calculated by Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||Week 12||0.43|0.26|<0.0001
72370826|NCT04518995|144251846|SUPERIORITY||Risk Difference (RD)|0.31|STANDARD_ERROR_OF_MEAN|0.035|<|0.0001|TWO_SIDED|95.0|0.24|0.38||P-value was calculated by Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||Week 16||0.38|0.24|<0.0001
72370827|NCT04518995|144251846|SUPERIORITY||Risk Difference (RD)|0.43|STANDARD_ERROR_OF_MEAN|0.041|<|0.0001|TWO_SIDED|95.0|0.35|0.51||P-value was calculated by Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||Week 16||0.51|0.35|<0.0001
72370828|NCT04518995|144251846|SUPERIORITY||Risk Difference (RD)|0.32|STANDARD_ERROR_OF_MEAN|0.033|<|0.0001|TWO_SIDED|95.0|0.26|0.39||P-value was calculated by Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||Week 20||0.39|0.26|<0.0001
72370829|NCT04518995|144251846|SUPERIORITY||Risk Difference (RD)|0.47|STANDARD_ERROR_OF_MEAN|0.04|<|0.0001|TWO_SIDED|95.0|0.39|0.55||P-value was calculated by Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||Week 20||0.55|0.39|<0.0001
72370830|NCT04518995|144251846|SUPERIORITY||Risk Difference (RD)|0.38|STANDARD_ERROR_OF_MEAN|0.033|<|0.0001|TWO_SIDED|95.0|0.31|0.44||P-value was calculated by Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||Week 24||0.44|0.31|<0.0001
72370831|NCT04518995|144251846|SUPERIORITY||Risk Difference (RD)|0.47|STANDARD_ERROR_OF_MEAN|0.039|<|0.0001|TWO_SIDED|95.0|0.39|0.55||P-value was calculated by Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||Week 24||0.55|0.39|<0.0001
72370832|NCT04518995|144251847|SUPERIORITY||Risk Difference (RD)|0.01|STANDARD_ERROR_OF_MEAN|0.005||0.0816|TWO_SIDED|95.0|0.0|0.02||P-value was calculated by Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||Week 4||0.02|-0.00|0.0816
72370833|NCT04518995|144251847|SUPERIORITY||Risk Difference (RD)|0.03|STANDARD_ERROR_OF_MEAN|0.01||0.0005|TWO_SIDED|95.0|0.01|0.05||P-value was calculated by Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||Week 8||0.05|0.01|0.0005
72370834|NCT04518995|144251847|SUPERIORITY||Risk Difference (RD)|0.06|STANDARD_ERROR_OF_MEAN|0.016||0.0002|TWO_SIDED|95.0|0.03|0.09||P-value was calculated by Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||Week 8||0.09|0.03|0.0002
72370835|NCT04518995|144251847|SUPERIORITY||Risk Difference (RD)|0.1|STANDARD_ERROR_OF_MEAN|0.018|<|0.0001|TWO_SIDED|95.0|0.06|0.14||P-value was calculated by Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||Week 12||0.14|0.06|<0.0001
72370836|NCT04518995|144251847|SUPERIORITY||Risk Difference (RD)|0.17|STANDARD_ERROR_OF_MEAN|0.027|<|0.0001|TWO_SIDED|95.0|0.12|0.22||P-value was calculated by Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||Week 12||0.22|0.12|<0.0001
72431843|NCT01016353|144375930|SUPERIORITY|||||||0.06|||||||Log Rank|||||||0.06
72493010|NCT03036293|144514791|SUPERIORITY||Median Difference (Net)|0.00002||||0.314|TWO_SIDED|95.0|-0.00002|0.33|||Wilcoxon (Mann-Whitney)||Hodges-Lehmann estimator for location difference provided|Median changes (begin-end) within groups are compared||0.33|-0.00002|0.314
72370837|NCT04518995|144251847|SUPERIORITY||Risk Difference (RD)|0.14|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001|TWO_SIDED|95.0|0.1|0.19||P-value was calculated by Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||Week 16||0.19|0.10|<0.0001
72370838|NCT04518995|144251847|SUPERIORITY||Risk Difference (RD)|0.27|STANDARD_ERROR_OF_MEAN|0.033|<|0.0001|TWO_SIDED|95.0|0.2|0.33||P-value was calculated by Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||Week 16||0.33|0.20|<0.0001
72431844|NCT02487446|144375931|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was demonstrated if the lower limit (LL) of the 97.5% one -sided confidence interval (CI) \> -20 mL.|Mean Difference (Net)|-0.0115|STANDARD_ERROR_OF_MEAN|0.00778||0.139|TWO_SIDED|95.0|-0.0269|0.0038||p-value unadjusted|Linear Mixed Model|||Ho: QVA149 27.5/12.5 μg b.i.d. is inferior to umeclidinium/vilanterol 62.5/25 μg q.d; Ha: QVA149 27.5/12.5 μg b.i.d. is non-inferior to umeclidinium/vilanterol 62.5/25 μg q.d.||0.0038|-0.0269|0.139
72431845|NCT02487446|144375932|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.0115|STANDARD_ERROR_OF_MEAN|0.00778|||TWO_SIDED|95.0|-0.0269|0.0038||||||Ho: QVA149 27.5/12.5 μg b.i.d. is inferior to umeclidinium/vilanterol 62.5/25 μg q.d; Ha: QVA149 27.5/12.5 μg b.i.d. is non-inferior to umeclidinium/vilanterol 62.5/25 μg q.d.||0.0038|-0.0269|
72553920|NCT03653507|144639953|SUPERIORITY||Hazard Ratio (HR)|1.012||||0.4654|TWO_SIDED|95.0|0.772|1.328|||Log Rank||Log-rank test stratified by:\* Region (Asia vs Non-Asia), \* Number of organs with metastatic sites (0 to 2 vs \>= 3), \* Prior gastrectomy (Yes or No)|||1.328|0.772|0.4654
72370839|NCT04518995|144251847|SUPERIORITY||Risk Difference (RD)|0.23|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001|TWO_SIDED|95.0|0.19|0.28||P-value was calculated by Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||Week 20||0.28|0.19|<0.0001
72370840|NCT04518995|144251847|SUPERIORITY||Risk Difference (RD)|0.35|STANDARD_ERROR_OF_MEAN|0.034|<|0.0001|TWO_SIDED|95.0|0.28|0.41||P-value was calculated by Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||Week 20||0.41|0.28|<0.0001
72370841|NCT04518995|144251848|SUPERIORITY||Least Square (LS) Mean Difference|-2.2|STANDARD_ERROR_OF_MEAN|1.13||0.0564|TWO_SIDED|95.0|-4.4|0.1||P-value was calculated by mixed model repeated measures (MMRM) analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value.|MMRM|||Week 4||0.1|-4.4|0.0564
72370842|NCT04518995|144251848|SUPERIORITY||LS Mean Difference|-3.4|STANDARD_ERROR_OF_MEAN|1.23||0.0054|TWO_SIDED|95.0|-5.9|-1.0||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value.|MMRM|||Week 4||-1.0|-5.9|0.0054
72370843|NCT04518995|144251848|SUPERIORITY||LS Mean Difference|-8.5|STANDARD_ERROR_OF_MEAN|2.16|<|0.0001|TWO_SIDED|95.0|-12.7|-4.3||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value.|MMRM|||Week 8||-4.3|-12.7|<0.0001
72370844|NCT04518995|144251848|SUPERIORITY||LS Mean Difference|-14.9|STANDARD_ERROR_OF_MEAN|2.34|<|0.0001|TWO_SIDED|95.0|-19.5|-10.3||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value.|MMRM|||Week 8||-10.3|-19.5|<0.0001
72370845|NCT04518995|144251848|SUPERIORITY||LS Mean Difference|-21.7|STANDARD_ERROR_OF_MEAN|2.94|<|0.0001|TWO_SIDED|95.0|-27.5|-16.0||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value.|MMRM|||Week 12||-16.0|-27.5|<0.0001
72370846|NCT04518995|144251848|SUPERIORITY||LS Mean Difference|-30.0|STANDARD_ERROR_OF_MEAN|3.19|<|0.0001|TWO_SIDED|95.0|-36.3|-23.8||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value.|MMRM|||Week 12||-23.8|-36.3|<0.0001
72370847|NCT04518995|144251848|SUPERIORITY||LS Mean Difference|-28.4|STANDARD_ERROR_OF_MEAN|3.38|<|0.0001|TWO_SIDED|95.0|-35.1|-21.8||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value.|MMRM|||Week 16||-21.8|-35.1|<0.0001
72370848|NCT04518995|144251848|SUPERIORITY||LS Mean Difference|-38.5|STANDARD_ERROR_OF_MEAN|3.66|<|0.0001|TWO_SIDED|95.0|-45.7|-31.3||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value.|MMRM|||Week 16||-31.3|-45.7|<0.0001
72370849|NCT04518995|144251848|SUPERIORITY||LS Mean Difference|-34.9|STANDARD_ERROR_OF_MEAN|3.66|<|0.0001|TWO_SIDED|95.0|-42.1|-27.7||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value.|MMRM|||Week 20||-27.7|-42.1|<0.0001
72370850|NCT04518995|144251848|SUPERIORITY||LS Mean Difference|-44.6|STANDARD_ERROR_OF_MEAN|3.96|<|0.0001|TWO_SIDED|95.0|-52.3|-36.8||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value.|MMRM|||Week 20||-36.8|-52.3|<0.0001
72370851|NCT04518995|144251848|SUPERIORITY||LS Mean Difference|-39.3|STANDARD_ERROR_OF_MEAN|3.79|<|0.0001|TWO_SIDED|95.0|-46.7|-31.8||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value.|MMRM|||Week 24||-31.8|-46.7|<0.0001
72431846|NCT02487446|144375933|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.0153|STANDARD_ERROR_OF_MEAN|0.01062|||TWO_SIDED|95.0|-0.0361|0.0056||||||||0.0056|-0.0361|
72431847|NCT02487446|144375934|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0051|STANDARD_ERROR_OF_MEAN|0.00806|||TWO_SIDED|95.0|-0.0108|0.0209||||||||0.0209|-0.0108|
72553921|NCT03653507|144639954|SUPERIORITY||Hazard Ratio (HR)|1.03||||0.4478|TWO_SIDED|95.0|0.673|1.577|||Log Rank||Log-rank test stratified by:\* Region (Asia vs Non-Asia), \* Number of organs with metastatic sites (0 to 2 vs \>= 3), \* Prior gastrectomy (Yes or No)|||1.577|0.673|0.4478
72370852|NCT04518995|144251848|SUPERIORITY||LS Mean Difference|-47.0|STANDARD_ERROR_OF_MEAN|4.1|<|0.0001|TWO_SIDED|95.0|-55.1|-39.0||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value.|MMRM|||Week 24||-39.0|-55.1|<0.0001
72370853|NCT04518995|144251849|SUPERIORITY||||||<|0.0001||||||P-value was calculated by cochran mantel haenszel (CMH) test stratified by baseline scalp hair loss (partial vs complete/near-complete) for responders in each treatment group compared to placebo.|Cochran-Mantel-Haenszel|||Week 12||||<0.0001
72370854|NCT04518995|144251849|SUPERIORITY||||||<|0.0001||||||P-value was calculated by CMH test stratified by baseline scalp hair loss (partial vs complete/near-complete) for responders in each treatment group compared to placebo.|Cochran-Mantel-Haenszel|||Week 12||||<0.0001
72370855|NCT04518995|144251849|SUPERIORITY||||||<|0.0001||||||P-value was calculated by CMH test stratified by baseline scalp hair loss (partial vs complete/near-complete) for responders in each treatment group compared to placebo.|Cochran-Mantel-Haenszel|||Week 16||||<0.0001
72370856|NCT04518995|144251849|SUPERIORITY||||||<|0.0001||||||P-value was calculated by CMH test stratified by baseline scalp hair loss (partial vs complete/near-complete) for responders in each treatment group compared to placebo.|Cochran-Mantel-Haenszel|||Week 16||||<0.0001
72370857|NCT04518995|144251849|SUPERIORITY||||||<|0.0001||||||P-value was calculated by CMH test stratified by baseline scalp hair loss (partial vs complete/near-complete) for responders in each treatment group compared to placebo.|Cochran-Mantel-Haenszel|||Week 20||||<0.0001
72370858|NCT04518995|144251849|SUPERIORITY||||||<|0.0001||||||P-value was calculated by CMH test stratified by baseline scalp hair loss (partial vs complete/near-complete) for responders in each treatment group compared to placebo.|Cochran-Mantel-Haenszel|||Week 20||||<0.0001
72370859|NCT04518995|144251849|SUPERIORITY||||||<|0.0001||||||P-value was calculated by CMH test stratified by baseline scalp hair loss (partial vs complete/near-complete) for responders in each treatment group compared to placebo.|Cochran-Mantel-Haenszel|||Week 24||||<0.0001
72370860|NCT04518995|144251849|SUPERIORITY||||||<|0.0001||||||P-value was calculated by CMH test stratified by baseline scalp hair loss (partial vs complete/near-complete) for responders in each treatment group compared to placebo.|Cochran-Mantel-Haenszel|||Week 24||||<0.0001
72370861|NCT04518995|144251850|SUPERIORITY||||||<|0.0001||||||P-value was calculated by CMH test stratified by baseline scalp hair loss (partial vs complete/near-complete) for responders in each treatment group compared to placebo.|Cochran-Mantel-Haenszel|||Week 12||||<0.0001
72370862|NCT04518995|144251850|SUPERIORITY||||||<|0.0001||||||P-value was calculated by CMH test stratified by baseline scalp hair loss (partial vs complete/near-complete) for responders in each treatment group compared to placebo.|Cochran-Mantel-Haenszel|||Week 12||||<0.0001
72370863|NCT04518995|144251850|SUPERIORITY||||||<|0.0001||||||P-value was calculated by CMH test stratified by baseline scalp hair loss (partial vs complete/near-complete) for responders in each treatment group compared to placebo.|Cochran-Mantel-Haenszel|||Week 16||||<0.0001
72431848|NCT01822821|144375940|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was tested using a noninferiority margin of 1.15.|ratio of geometric means|0.89||||0.08|ONE_SIDED|90.0||1.06|||Regression, Linear||Ratio of geometric means (CI) for IV acetaminophen versus placebo was estimated as the exponentiated treatment effect parameter from a multivariable linear regression model on log opioid consumption adjusting for age and diabetes.|||1.06||0.08
72431849|NCT01822821|144375940|SUPERIORITY_OR_OTHER||ratio of geometric means|0.89||||0.28|ONE_SIDED|95.0||1.1|||Regression, Linear||Ratio of geometric means (CI) for IV acetaminophen versus placebo was estimated as the exponentiated treatment effect parameter from a multivariable linear regression model on log opioid consumption adjusting for age and diabetes.|||1.10||0.28
72431850|NCT01822821|144375941|NON_INFERIORITY_OR_EQUIVALENCE|We assessed whether IV acetaminophen is noninferior to placebo using a noninferiority margin of 1.0.|Median Difference (Final Values)|-0.9|||<|0.001|ONE_SIDED|90.0||-0.5|||Regression, Linear||Difference in overall postoperative pain score means based on a repeated measures linear regression model with an autoregressive correlation structure, adjusting for age, time, and diabetes.|||-0.5||< 0.001
72431851|NCT01822821|144375941|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9|||<|0.001|ONE_SIDED|95.0||-0.42|||Regression, Linear||Difference in overall postoperative pain score means based on a repeated measures linear regression model with an autoregressive correlation structure, adjusting for age, time, and diabetes.|||-0.42||< 0.001
72370864|NCT04518995|144251850|SUPERIORITY||||||<|0.0001||||||P-value was calculated by CMH test stratified by baseline scalp hair loss (partial vs complete/near-complete) for responders in each treatment group compared to placebo.|Cochran-Mantel-Haenszel|||Week 16||||<0.0001
72553922|NCT03653507|144639955|SUPERIORITY||Hazard Ratio (HR)|0.869||||0.167|TWO_SIDED|95.0|0.655|1.153|||Log Rank||Log-rank test stratified by:\* Region (Asia vs Non-Asia), \* Number of organs with metastatic sites (0 to 2 vs \>= 3), \* Prior gastrectomy (Yes or No)|||1.153|0.655|0.1670
72370865|NCT04518995|144251850|SUPERIORITY||||||<|0.0001||||||P-value was calculated by CMH test stratified by baseline scalp hair loss (partial vs complete/near-complete) for responders in each treatment group compared to placebo.|Cochran-Mantel-Haenszel|||Week 20||||<0.0001
72370866|NCT04518995|144251850|SUPERIORITY||||||<|0.0001||||||P-value was calculated by CMH test stratified by baseline scalp hair loss (partial vs complete/near-complete) for responders in each treatment group compared to placebo.|Cochran-Mantel-Haenszel|||Week 20||||<0.0001
72370867|NCT04518995|144251850|SUPERIORITY||||||<|0.0001||||||P-value was calculated by CMH test stratified by baseline scalp hair loss (partial vs complete/near-complete) for responders in each treatment group compared to placebo.|Cochran-Mantel-Haenszel|||Week 24||||<0.0001
72370868|NCT04518995|144251850|SUPERIORITY||||||<|0.0001||||||P-value was calculated by CMH test stratified by baseline scalp hair loss (partial vs complete/near-complete) for responders in each treatment group compared to placebo.|Cochran-Mantel-Haenszel|||Week 24||||<0.0001
72370869|NCT04518995|144251851|SUPERIORITY||LS Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-1.2|-0.7||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Week 12||-0.7|-1.2|<0.0001
72370870|NCT04518995|144251851|SUPERIORITY||LS Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-1.5|-0.9||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Week 12||-0.9|-1.5|<0.0001
72431852|NCT01822821|144375942|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.76||||0.35|TWO_SIDED|99.4|0.34|1.7|||Regression, Logistic||Relative risk of PONV in IV acetaminophen versus placebo patients estimated from a multivariable logistic regression model using the log link and adjusting for age and diabetes.|||1.7|0.34|0.35
72431853|NCT01822821|144375943|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.13|TWO_SIDED|99.8|0.0|0.0|||Wilcoxon (Mann-Whitney)||Difference in medians of IV acetaminophen versus placebo patients based on Wilcoxon rank sum test and Hodges-Lehmann estimation of location shift.|Analysis at 8 hours after surgery.||0|0|0.13
72431854|NCT01822821|144375943|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.44|TWO_SIDED|99.8|0.0|0.0|||Wilcoxon (Mann-Whitney)||Difference in medians of IV acetaminophen versus placebo patients based on Wilcoxon rank sum test and Hodges-Lehmann estimation of location shift.|Analysis at 16 hours after surgery.||0|0|0.44
72370871|NCT04518995|144251851|SUPERIORITY||LS Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|0.15|<|0.0001|TWO_SIDED|95.0|-1.4|-0.9||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Week 16||-0.9|-1.4|<0.0001
72370872|NCT04518995|144251851|SUPERIORITY||LS Mean Difference|-1.6|STANDARD_ERROR_OF_MEAN|0.16|<|0.0001|TWO_SIDED|95.0|-1.9|-1.3||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Week 16||-1.3|-1.9|<0.0001
72370873|NCT04518995|144251851|SUPERIORITY||LS Mean Difference|-1.5|STANDARD_ERROR_OF_MEAN|0.16|<|0.0001|TWO_SIDED|95.0|-1.8|-1.2||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Week 20||-1.2|-1.8|<0.0001
72370874|NCT04518995|144251851|SUPERIORITY||LS Mean Difference|-1.9|STANDARD_ERROR_OF_MEAN|0.18|<|0.0001|TWO_SIDED|95.0|-2.3|-1.6||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Week 20||-1.6|-2.3|<0.0001
72370875|NCT04518995|144251851|SUPERIORITY||LS Mean Difference|-1.7|STANDARD_ERROR_OF_MEAN|0.18|<|0.0001|TWO_SIDED|95.0|-2.0|-1.3||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Week 24||-1.3|-2.0|<0.0001
72370876|NCT04518995|144251851|SUPERIORITY||LS Mean Difference|-2.1|STANDARD_ERROR_OF_MEAN|0.19|<|0.0001|TWO_SIDED|95.0|-2.5|-1.7||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Week 24||-1.7|-2.5|<0.0001
72370877|NCT04518995|144251852|SUPERIORITY||LS Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.16|<|0.0001|TWO_SIDED|95.0|-0.9|-0.3||P-value was calculated by MMRM with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Week 12||-0.3|-0.9|<0.0001
72370878|NCT04518995|144251852|SUPERIORITY||LS Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.17|<|0.0001|TWO_SIDED|95.0|-1.3|-0.6||P-value was calculated by MMRM with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Week 12||-0.6|-1.3|<0.0001
72370879|NCT04518995|144251852|SUPERIORITY||LS Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|0.17|<|0.0001|TWO_SIDED|95.0|-1.6|-0.9||P-value was calculated by MMRM with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Week 16||-0.9|-1.6|<0.0001
72370880|NCT04518995|144251852|SUPERIORITY||LS Mean Difference|-1.7|STANDARD_ERROR_OF_MEAN|0.18|<|0.0001|TWO_SIDED|95.0|-2.1|-1.4||P-value was calculated by MMRM with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Week 16||-1.4|-2.1|<0.0001
72370881|NCT04518995|144251852|SUPERIORITY||LS Mean Difference|-1.4|STANDARD_ERROR_OF_MEAN|0.18|<|0.0001|TWO_SIDED|95.0|-1.7|-1.0||P-value was calculated by MMRM with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Week 20||-1.0|-1.7|<0.0001
72370882|NCT04518995|144251852|SUPERIORITY||LS Mean Difference|-1.9|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001|TWO_SIDED|95.0|-2.3|-1.5||P-value was calculated by MMRM with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Week 20||-1.5|-2.3|<0.0001
72370883|NCT04518995|144251852|SUPERIORITY||LS Mean Difference|-1.7|STANDARD_ERROR_OF_MEAN|0.19|<|0.0001|TWO_SIDED|95.0|-2.0|-1.3||P-value was calculated by MMRM with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Week 24||-1.3|-2.0|<0.0001
72370884|NCT04518995|144251852|SUPERIORITY||LS Mean Difference|-2.2|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001|TWO_SIDED|95.0|-2.6|-1.8||P-value was calculated by MMRM with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Week 24||-1.8|-2.6|<0.0001
72370885|NCT04518995|144251853|SUPERIORITY||Risk Difference (RD)|0.09|STANDARD_ERROR_OF_MEAN|0.016|<|0.0001|TWO_SIDED|95.0|0.06|0.12||P-value was calculated by mantel-haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||75% Relative Reduction: Week 12||0.12|0.06|<0.0001
72370886|NCT04518995|144251853|SUPERIORITY||Risk Difference (RD)|0.17|STANDARD_ERROR_OF_MEAN|0.026|<|0.0001|TWO_SIDED|95.0|0.12|0.22||P-value was calculated by mantel-haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||75% Relative Reduction: Week 12||0.22|0.12|<0.0001
72370887|NCT04518995|144251853|SUPERIORITY||Risk Difference (RD)|0.28|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.23|0.33||P-value was calculated by mantel-haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||75% Relative Reduction: Week 24||0.33|0.23|<0.0001
72370888|NCT04518995|144251853|SUPERIORITY||Risk Difference (RD)|0.38|STANDARD_ERROR_OF_MEAN|0.033|<|0.0001|TWO_SIDED|95.0|0.32|0.45||P-value was calculated by mantel-haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||75% Relative Reduction: Week 24||0.45|0.32|<0.0001
72370889|NCT04518995|144251853|SUPERIORITY||Risk Difference (RD)|0.04|STANDARD_ERROR_OF_MEAN|0.01||0.0006|TWO_SIDED|95.0|0.02|0.06||P-value was calculated by mantel-haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||90% Relative Reduction: Week 12||0.06|0.02|0.0006
72370890|NCT04518995|144251853|SUPERIORITY||Risk Difference (RD)|0.1|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001|TWO_SIDED|95.0|0.06|0.14||P-value was calculated by mantel-haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||90% Relative Reduction: Week 12||0.14|0.06|<0.0001
72370891|NCT04518995|144251853|SUPERIORITY||Risk Difference (RD)|0.19|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001|TWO_SIDED|95.0|0.15|0.23||P-value was calculated by mantel-haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||90% Relative Reduction: Week 24||0.23|0.15|<0.0001
72370892|NCT04518995|144251853|SUPERIORITY||Risk Difference (RD)|0.3|STANDARD_ERROR_OF_MEAN|0.032|<|0.0001|TWO_SIDED|95.0|0.24|0.37||P-value was calculated by mantel-haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||90% Relative Reduction: Week 24||0.37|0.24|<0.0001
72370893|NCT04518995|144251854|SUPERIORITY||LS Mean Difference|0.7|STANDARD_ERROR_OF_MEAN|0.22||0.001|TWO_SIDED|95.0|0.3|1.2||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Week 12||1.2|0.3|0.0010
72370894|NCT04518995|144251854|SUPERIORITY||LS Mean Difference|1.1|STANDARD_ERROR_OF_MEAN|0.23|<|0.0001|TWO_SIDED|95.0|0.6|1.6||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Week 12||1.6|0.6|<0.0001
72431855|NCT01822821|144375943|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.38|TWO_SIDED|99.8|0.0|0.0|||Wilcoxon (Mann-Whitney)||Difference in medians of IV acetaminophen versus placebo patients based on Wilcoxon rank sum test and Hodges-Lehmann estimation of location shift.|Analysis at 24 hours after surgery||0|0|0.38
72431856|NCT01822821|144375944|SUPERIORITY_OR_OTHER||ratio of geometric means|1.3||||0.46|TWO_SIDED|99.4|0.52|3.2|||Regression, Linear||Outcome log-transformed to meet model assumptions. The treatment effect on duration of mechanical ventilation was assessed by use of the ratio of geometric means from a multivariable logistic regression models adjusting for age and diabetes.|||3.20|0.52|0.46
72614792|NCT01922011|144759519|SUPERIORITY_OR_OTHER||Common difference|-12.2|||||TWO_SIDED|95.0|-27.2|2.8|||||95% confidence interval of the common difference ( Daptomycin minus Vancomycin or Nafcillin) is based on stratified Newcombe confidence interval (CI) with minimum risk weights, with age cohort as the stratification factor.|SA||2.8|-27.2|
72370895|NCT04518995|144251854|SUPERIORITY||LS Mean Difference|1.7|STANDARD_ERROR_OF_MEAN|0.24|<|0.0001|TWO_SIDED|95.0|1.2|2.2||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Week 24||2.2|1.2|<0.0001
72370896|NCT04518995|144251854|SUPERIORITY||LS Mean Difference|1.9|STANDARD_ERROR_OF_MEAN|0.26|<|0.0001|TWO_SIDED|95.0|1.4|2.4||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Week 24||2.4|1.4|<0.0001
72370897|NCT04518995|144251855|SUPERIORITY||LS Mean Difference|0.9|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001|TWO_SIDED|95.0|0.5|1.3||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Week 12||1.3|0.5|<0.0001
72370898|NCT04518995|144251855|SUPERIORITY||LS Mean Difference|1.4|STANDARD_ERROR_OF_MEAN|0.22|<|0.0001|TWO_SIDED|95.0|1.0|1.8||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Week 12||1.8|1.0|<0.0001
72370899|NCT04518995|144251855|SUPERIORITY||LS Mean Difference|1.5|STANDARD_ERROR_OF_MEAN|0.24|<|0.0001|TWO_SIDED|95.0|1.0|2.0||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Week 24||2.0|1.0|<0.0001
72370900|NCT04518995|144251855|SUPERIORITY||LS Mean Difference|1.9|STANDARD_ERROR_OF_MEAN|0.26|<|0.0001|TWO_SIDED|95.0|1.4|2.4||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Week 24||2.4|1.4|<0.0001
72370901|NCT04518995|144251856|SUPERIORITY||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-1.0|-0.5||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value.|MMRM|||Week 12||-0.5|-1.0|< 0.0001
72370902|NCT04518995|144251856|SUPERIORITY||LS Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-1.3|-0.8||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value.|MMRM|||Week 12||-0.8|-1.3|< 0.0001
72370903|NCT04518995|144251856|SUPERIORITY||LS Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-1.2|-0.8||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value.|MMRM|||Week 16||-0.8|-1.2|< 0.0001
72370904|NCT04518995|144251856|SUPERIORITY||LS Mean Difference|-1.4|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-1.6|-1.1||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value.|MMRM|||Week 16||-1.1|-1.6|< 0.0001
72614793|NCT01922011|144759519|SUPERIORITY_OR_OTHER||Common difference|-10.4|||||TWO_SIDED|95.0|-25.4|5.2|||||95% confidence interval of the common difference ( Daptomycin minus Vancomycin or Nafcillin) is based on stratified Newcombe confidence interval (CI) with minimum risk weights, with age cohort as the stratification factor.|MSSA||5.2|-25.4|
72370905|NCT04518995|144251856|SUPERIORITY||LS Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-1.3|-0.8||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value.|MMRM|||Week 20||-0.8|-1.3|< 0.0001
72370906|NCT04518995|144251856|SUPERIORITY||LS Mean Difference|-1.5|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-1.7|-1.2||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value.|MMRM|||Week 20||-1.2|-1.7|< 0.0001
72370907|NCT04518995|144251856|SUPERIORITY||LS Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-1.5|-1.0||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value.|MMRM|||Week 24||-1.0|-1.5|< 0.0001
72370908|NCT04518995|144251856|SUPERIORITY||LS Mean Difference|-1.6|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-1.8|-1.3||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value.|MMRM|||Week 24||-1.3|-1.8|< 0.0001
72370909|NCT04518995|144251857|SUPERIORITY||Risk Difference (RD)|0.25|STANDARD_ERROR_OF_MEAN|0.044|<|0.0001|TWO_SIDED|95.0|0.17|0.34||P-value was calculated by the Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||Week 12||0.34|0.17|< 0.0001
72370910|NCT04518995|144251857|SUPERIORITY||Risk Difference (RD)|0.32|STANDARD_ERROR_OF_MEAN|0.049|<|0.0001|TWO_SIDED|95.0|0.23|0.42||P-value was calculated by the Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||Week 12||0.42|0.23|< 0.0001
72622148|NCT04003142|144774326|SUPERIORITY||Odds Ratio (OR)|3.474||||0.062||95.0|1.039|15.712||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 4||15.712|1.039|0.062
72431857|NCT01822821|144375945|SUPERIORITY_OR_OTHER||ratio of geometric means|0.93||||0.38|TWO_SIDED|99.4|0.74|1.2|||Regression, Linear||Outcome log-transformed to meet model assumptions. The treatment effect on duration of ICU stay was assessed by use of the ratio of geometric means from a multivariable logistic regression models adjusting for age and diabetes.|||1.20|0.74|0.38
72431858|NCT01822821|144375946|SUPERIORITY_OR_OTHER||ratio of geometric means|1.1||||0.12|TWO_SIDED|99.4|0.94|1.2|||Regression, Linear||Outcome log-transformed to meet model assumptions. The treatment effect on duration of mechanical ventilation was assessed by use of the ratio of geometric means from a multivariable logistic regression models adjusting for age and diabetes.|||1.20|0.94|0.12
72431859|NCT01822821|144375947|SUPERIORITY_OR_OTHER||ratio of geometric means|1.1||||0.31|TWO_SIDED|99.4|0.9|1.2|||Regression, Linear||Outcome log-transformed to meet model assumptions. The treatment effect on ALT was assessed by use of the ratio of geometric means from a repeated measures multivariable logistic regression models adjusting for age and diabetes.|||1.2|0.9|0.31
72431860|NCT01822821|144375948|SUPERIORITY_OR_OTHER||ratio of geometric means|1.0||||0.98|TWO_SIDED|99.4|0.8|1.2|||Regression, Linear||Outcome log-transformed to meet model assumptions. The treatment effect on AST was assessed by use of the ratio of geometric means from a repeated measures multivariable logistic regression models adjusting for age and diabetes.|||1.2|0.8|0.98
72431861|NCT01822821|144375949|SUPERIORITY_OR_OTHER||ratio of geometric means|1.1||||0.4|TWO_SIDED|99.4|0.87|1.3|||Regression, Linear||Outcome log-transformed to meet model assumptions. The treatment effect on bilirubin was assessed by use of the ratio of geometric means from a repeated measures multivariable logistic regression models adjusting for age and diabetes.|||1.3|0.87|0.40
72431862|NCT05780047|144375950|OTHER||||||<|0.05|||||||t-test, 1 sided|||||||<0.05
72370911|NCT04518995|144251857|SUPERIORITY||Risk Difference (RD)|0.35|STANDARD_ERROR_OF_MEAN|0.04|<|0.0001|TWO_SIDED|95.0|0.27|0.42||P-value was calculated by the Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||Week 16||0.42|0.27|< 0.0001
72431863|NCT05780047|144375951|OTHER||||||<|0.05|||||||paired samples t-test|||Paired samples t-tests were run to compare whether EHL knowledge, attitudes and behavior changed after the intervention. EHL scores were expected to increase between pre and post testing.||||<0.05
72370912|NCT04518995|144251857|SUPERIORITY||Risk Difference (RD)|0.39|STANDARD_ERROR_OF_MEAN|0.045|<|0.0001|TWO_SIDED|95.0|0.3|0.48||P-value was calculated by the Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||Week 16||0.48|0.30|< 0.0001
72370913|NCT04518995|144251857|SUPERIORITY||Risk Difference (RD)|0.34|STANDARD_ERROR_OF_MEAN|0.04|<|0.0001|TWO_SIDED|95.0|0.26|0.42||P-value was calculated by the Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||Week 20||0.42|0.26|< 0.0001
72370914|NCT04518995|144251857|SUPERIORITY||Risk Difference (RD)|0.42|STANDARD_ERROR_OF_MEAN|0.045|<|0.0001|TWO_SIDED|95.0|0.34|0.51||P-value was calculated by the Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||Week 20||0.51|0.34|< 0.0001
72431864|NCT04438785|144375963|SUPERIORITY||Mean Difference (Final Values)|2.58|||<|0.001|TWO_SIDED||||||t-test, 2 sided|||Evaluate if the Apnea Hypopnea Index from Baseline and after three months in the Intervention Group showed statistical significant difference p\<0.05 .||||<0.001
72370915|NCT04518995|144251857|SUPERIORITY||Risk Difference (RD)|0.37|STANDARD_ERROR_OF_MEAN|0.039|<|0.0001|TWO_SIDED|95.0|0.29|0.44||P-value was calculated by the Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||Week 24||0.44|0.29|< 0.0001
72370916|NCT04518995|144251857|SUPERIORITY||Risk Difference (RD)|0.44|STANDARD_ERROR_OF_MEAN|0.045|<|0.0001|TWO_SIDED|95.0|0.35|0.53||P-value was calculated by the Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||Week 24||0.53|0.35|< 0.0001
72431865|NCT04438785|144375964|SUPERIORITY||Median Difference (Final Values)|-0.971||||0.003|TWO_SIDED||||||t-test, 2 sided|||Evaluate if the O2 desaturation index (ODI) from Baseline and after three months in the Intervention Group showed statistical significant difference p\<0.05 .||||0.003
72622149|NCT04003142|144774326|SUPERIORITY||Odds Ratio (OR)|6.184||||0.004||95.0|2.025|26.875||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 4||26.875|2.025|0.004
72370917|NCT04518995|144251858|SUPERIORITY||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001|TWO_SIDED|95.0|-0.9|-0.5||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Satisfied Thickness Hair Coverage: Week 12||-0.5|-0.9|<0.0001
72370918|NCT04518995|144251858|SUPERIORITY||LS Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-1.2|-0.7||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score|MMRM|||Satisfied Thickness Hair Coverage: Week 12||-0.7|-1.2|<0.0001
72431866|NCT04438785|144375965|SUPERIORITY||Mean Difference (Net)|-0.364||||0.001|ONE_SIDED||||||t-test, 2 sided|||Evaluate if the IOPI tongue score from baseline and after three months in the Intervention Group showed statistical significant difference p\<0.05 .||||0.001
72431867|NCT04438785|144375966|SUPERIORITY||Median Difference (Final Values)|-1.131||||0.001|ONE_SIDED|95.0|||||t-test, 2 sided|||Evaluate if the IOPI lip score from the baseline and after three months in the Intervention Group showed statistical significant difference p\<0.05 .||||0.001
72431868|NCT04438785|144375967|SUPERIORITY||Mean Difference (Final Values)|0.98||||0.92|ONE_SIDED|95.0|||||t-test, 2 sided|||Evaluate if the neck circumference from Baseline and after three months in the Intervention Group showed statistical significant difference p\<0.05 .||||0.92
72431869|NCT04438785|144375968|SUPERIORITY||Mean Difference (Final Values)|0.98||||0.92|ONE_SIDED||||||t-test, 2 sided|||Evaluate if the waist circumference from baseline and after three months in the Intervention Group showed statistical significant difference p\<0.05 .||||0.92
72431870|NCT04438785|144375969|SUPERIORITY||Mean Difference (Final Values)|0.97||||0.98|ONE_SIDED|95.0|||||t-test, 2 sided|||Evaluate if the BMI from Baseline and after three months in the Intervention Group showed statistical significant difference p\<0.05 .||||0.98
72431871|NCT04438785|144375970|SUPERIORITY||Median Difference (Final Values)|-1.23||||0.001|ONE_SIDED|95.0|||||t-test, 2 sided|||Evaluate if the Epworth Sleepiness Scale from Baseline and after three months in the Intervention Group showed statistical significant difference p\<0.05 .||||0.001
72431872|NCT04438785|144375971|SUPERIORITY||Mean Difference (Net)|0.98||||0.22|ONE_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||Evaluate if the Pittsburgh sleep quality index from Baseline and after three months in the Intervention Group showed statistical significant difference p\<0.05 .||||0.22
72431873|NCT04011033|144375972|OTHER||Hazard Ratio (HR)|0.32|||<|0.001|TWO_SIDED|95.0|0.16|0.63|||Log Rank|||||0.63|0.16|<0.001
72431874|NCT04011033|144375974|OTHER||||||=|0.003|||||||Fisher Exact|||||||=0.003
72431875|NCT04011033|144375975|OTHER||||||<|0.001|||||||Fisher Exact|||||||<0.001
72614794|NCT00063622|144759536|SUPERIORITY_OR_OTHER|||||||0.001||||||Given the fact that there were two planned primary comparisons, Bonferroni-adjusted P values of less than 0.025 were considered to indicate statistical significance.|Mantel Haenszel|||The proportions in each active-treatment group (pioglitazone and vitamin E) in whom there was improvement in non-alcoholic steatohepatitis were compared with the proportion of subjects in the placebo group in whom there was improvement.||||0.001
72370919|NCT04518995|144251858|SUPERIORITY||LS Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-1.1|-0.6||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score|MMRM|||Satisfied Thickness Hair Coverage: Week 16||-0.6|-1.1|<0.0001
72370920|NCT04518995|144251858|SUPERIORITY||LS Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-1.4|-1.0||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score|MMRM|||Satisfied Thickness Hair Coverage: Week 16||-1.0|-1.4|<0.0001
72370921|NCT04518995|144251858|SUPERIORITY||LS Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-1.2|-0.8||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Satisfied Thickness Hair Coverage: Week 20||-0.8|-1.2|<0.0001
72370922|NCT04518995|144251858|SUPERIORITY||LS Mean Difference|-1.3|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-1.6|-1.1||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Satisfied Thickness Hair Coverage: Week 20||-1.1|-1.6|<0.0001
72370923|NCT04518995|144251858|SUPERIORITY||LS Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-1.3|-0.8||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Satisfied Thickness Hair Coverage: Week 24||-0.8|-1.3|<0.0001
72370924|NCT04518995|144251858|SUPERIORITY||LS Mean Difference|-1.4|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-1.7|-1.2||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Satisfied Thickness Hair Coverage: Week 24||-1.2|-1.7|<0.0001
72370925|NCT04518995|144251858|SUPERIORITY||LS Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001|TWO_SIDED|95.0|-0.8|-0.4||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Satisfied Evenness Hair Coverage: Week 12||-0.4|-0.8|<0.0001
72370926|NCT04518995|144251858|SUPERIORITY||LS Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001|TWO_SIDED|95.0|-1.1|-0.7||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Satisfied Evenness Hair Coverage: Week 12||-0.7|-1.1|<0.0001
72431876|NCT04011033|144375977|OTHER||Hazard Ratio (HR)|0.37|||=|0.001|TWO_SIDED|95.0|0.19|0.71|||Log Rank|||||0.71|0.19|=0.001
72493011|NCT03036293|144514791|SUPERIORITY||Median Difference (Net)|0.0||||0.031|TWO_SIDED|95.0|0.0|1.0|||Wilcoxon (Mann-Whitney)||Hodges-Lehmann estimator for location difference provided|Median changes (begin-end) within groups are compared||1|0|0.031
72370927|NCT04518995|144251858|SUPERIORITY||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001|TWO_SIDED|95.0|-0.9|-0.5||P-value was calculated by MMRM mixed model repeated measures analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Satisfied Evenness Hair Coverage: Week 16||-0.5|-0.9|<0.0001
72370928|NCT04518995|144251858|SUPERIORITY||LS Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-1.3|-0.8||P-value was calculated by MMRM mixed model repeated measures analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Satisfied Evenness Hair Coverage: Week 16||-0.8|-1.3|<0.0001
72431877|NCT00689104|144375980|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.41||||0.003|TWO_SIDED|95.0|-0.72|-0.09||The response variable for the stratified rank ANCOVA was standardized ranks on change from baseline to Final Visit value with baseline standardized ranks and gender as covariates and geographic region as a stratum.|Stratified rank ANCOVA|LS mean difference was derived from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.||Since there were 2 coprimary efficacy endpoints and 3 key secondary efficacy endpoints, the multiplicity among the endpoints was controlled at a type I error rate at the alpha = 0.05 level using a stepwise parallel gatekeeping procedure (5 stages). In addition, since two mirabegron treatment groups were compared with placebo per endpoint, the Hochberg procedure was used to adjust for multiplicity. A stratified rank ANCOVA model was utilized for hypothesis testing.||-0.09|-0.72|0.003
72469364|NCT03721172|144462401|SUPERIORITY||Adjusted difference|24.7|||<|0.0001|TWO_SIDED|95.0|16.5|32.8|||Cochran-Mantel-Haenszel|Stratification were based on baseline sPGA (2 \[mild\] vs 3 \[moderate\]).|2-sided 95% CIs based on the stratified Newcombe method. Stratification were based on baseline sPGA (2 \[mild\] vs 3 \[moderate\]).|||32.8|16.5|<0.0001
72469365|NCT03721172|144462402|SUPERIORITY||Adjusted difference|27.4|||<|0.0001|TWO_SIDED|95.0|18.6|36.3|||Cochran-Mantel-Haenszel|Stratification were based on baseline sPGA (2 \[mild\] vs 3 \[moderate\]).|2-sided 95% CIs based on the stratified Newcombe method. Stratification were based on baseline sPGA (2 \[mild\] vs 3 \[moderate\]).|||36.3|18.6|<0.0001
72493012|NCT03036293|144514792|SUPERIORITY||Median Difference (Net)|-0.00001||||0.0021|TWO_SIDED|95.0|-3.0|-0.00001|||Wilcoxon (Mann-Whitney)||Lower is better|||-0.00001|-3|0.0021
72493013|NCT03036293|144514792|SUPERIORITY||Median Difference (Net)|-0.00002||||0.0056|TWO_SIDED|95.0|-1.0|-0.00002|||Wilcoxon (Mann-Whitney)||Lower is better|||-0.00002|-1|0.0056
72614795|NCT00063622|144759536|SUPERIORITY_OR_OTHER|||||||0.04||||||Given the fact that there were two planned primary comparisons, Bonferroni-adjusted P values of less than 0.025 were considered to indicate statistical significance.|Mantel Haenszel|||The proportions in each active-treatment group (pioglitazone and vitamin E) in whom there was improvement in non-alcoholic steatohepatitis were compared with the proportion of subjects in the placebo group in whom there was improvement.||||0.04
72370929|NCT04518995|144251858|SUPERIORITY||LS Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-1.1|-0.7||P-value was calculated by MMRM mixed model repeated measures analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Satisfied Evenness Hair Coverage: Week 20||-0.7|-1.1|<0.0001
72370930|NCT04518995|144251858|SUPERIORITY||LS Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-1.5|-1.0||P-value was calculated by MMRM mixed model repeated measures analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Satisfied Evenness Hair Coverage: Week 20||-1.0|-1.5|<0.0001
72370931|NCT04518995|144251858|SUPERIORITY||LS Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-1.2|-0.7||P-value was calculated by MMRM mixed model repeated measures analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Satisfied Evenness Hair Coverage: Week 24||-0.7|-1.2|<0.0001
72614796|NCT00063622|144759537|SUPERIORITY_OR_OTHER|||||||0.005||95.0|||||Fisher Exact|||||||0.005
72614797|NCT00063622|144759537|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Fisher Exact|||||||<0.001
72614798|NCT00063622|144759538|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||Fisher Exact|||||||0.02
72614799|NCT00063622|144759538|SUPERIORITY_OR_OTHER|||||||0.004||95.0|||||Fisher Exact|||||||0.004
72614800|NCT00063622|144759539|SUPERIORITY_OR_OTHER|||||||0.01||95.0|||||Fisher Exact|||||||0.01
72614801|NCT00063622|144759539|SUPERIORITY_OR_OTHER|||||||0.08||95.0|||||Fisher Exact|||||||0.08
72614802|NCT00063622|144759540|SUPERIORITY_OR_OTHER|||||||0.24||95.0|||||Fisher Exact|||||||0.24
72614803|NCT00063622|144759540|SUPERIORITY_OR_OTHER|||||||0.12||95.0|||||Fisher Exact|||||||0.12
72614804|NCT00063622|144759541|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||Fisher Exact|||||||0.05
72614805|NCT00063622|144759541|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||Fisher Exact|||||||0.001
72614806|NCT04615507|144759553|SUPERIORITY|The superiority of the Test lens will be concluded if the upper confidence limit of the mean is below the predefined threshold +0.00 logMAR for Distance.|Mean estimate|-0.132|STANDARD_ERROR_OF_MEAN|0.0201|||TWO_SIDED|95.0|-0.18|-0.083|||Linear Mixed Model|Kenward and Roger Method was used for denominator degrees of freedom.||||-0.083|-0.180|
72614807|NCT04615507|144759553|SUPERIORITY|The superiority of the Test lens will be concluded if the upper confidence limit of the mean is below the predefined threshold +0.17 logMAR for Intermediate.|Mean estimate|-0.066|STANDARD_ERROR_OF_MEAN|0.0202|||TWO_SIDED|95.0|-0.115|-0.017|||Linear Mixed Model|Kenward and Roger Method was used for denominator degrees of freedom.||||-0.017|-0.115|
72370932|NCT04518995|144251858|SUPERIORITY||LS Mean Difference|-1.3|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-1.5|-1.0||P-value was calculated by MMRM mixed model repeated measures analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Satisfied Evenness Hair Coverage: Week 24||-1.0|-1.5|<0.0001
72370933|NCT04518995|144251858|SUPERIORITY||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001|TWO_SIDED|95.0|-0.9|-0.5||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||How Satisfied With Your Eyebrows: Week 12||-0.5|-0.9|< 0.0001
72370934|NCT04518995|144251858|SUPERIORITY||LS Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-1.1|-0.6||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||How Satisfied With Your Eyebrows: Week 12||-0.6|-1.1|< 0.0001
72614808|NCT04615507|144759553|SUPERIORITY|The superiority of the Test lens will be concluded if the upper confidence limit of the mean is below the predefined threshold +0.17 logMAR for Near.|Mean estimate|0.072|STANDARD_ERROR_OF_MEAN|0.0217|||TWO_SIDED|95.0|0.022|0.121|||Linear Mixed Model|Kenward and Roger Method was used for denominator degrees of freedom.||||0.121|0.022|
72614809|NCT04615507|144759554|SUPERIORITY|The superiority of the Test lens will be concluded if the lower confidence limit of the LSM is above the predefined threshold 32 points.|Least-square mean|59.6|STANDARD_ERROR_OF_MEAN|3.05|||TWO_SIDED|95.0|52.3|66.8|||Linear Mixed Model|Kenward and Roger Method was used for the denominator degrees of freedom||||66.8|52.3|
72614810|NCT04615507|144759554|NON_INFERIORITY|The non-Inferiority of the Test lens relative to the Control will be concluded if the lower confidence limit of LSM difference is above -5 points.|Least-square mean difference|5.5|STANDARD_ERROR_OF_MEAN|2.36|||TWO_SIDED|95.0|0.9|10.2|||Linear Mixed Model|Kenward and Roger Method was used for the denominator degrees of freedom|LSM difference was calculated as Test minus Control|||10.2|0.9|
72469366|NCT03721172|144462403|SUPERIORITY||Least squares mean difference|-2.9|STANDARD_ERROR_OF_MEAN|0.4|<|0.0001|TWO_SIDED|95.0|-3.7|-2.1|||Mixed-effect model for repeated measures|||||-2.1|-3.7|<0.0001
72553923|NCT03653507|144639956|SUPERIORITY|||||||0.2219||||||Based on 1-sided Cochran-Mantel-Haenszel (CMH) test. Stratification factors were Region, Number of Metastatic Sites and Prior Gastrectomy.|Cochran-Mantel-Haenszel|||||||0.2219
72614811|NCT02583269|144759624|OTHER|||||||0.76|||||||ANOVA|||Overall FACT G score p value baseline to week 8||||0.76
72614812|NCT02583269|144759624|OTHER|||||||0.25|||||||ANOVA|||Fact G functional well being p value baseline to week 8||||0.25
72614813|NCT02583269|144759624|OTHER|||||||0.18|||||||ANOVA|||FACT G emotional well being p value baseline to week 8||||0.18
72614814|NCT02583269|144759624|OTHER|||||||0.87|||||||ANOVA|||Fact G physical well being p value baseline to week 8||||0.87
72614815|NCT02583269|144759624|OTHER|||||||0.22|||||||ANOVA|||Fact G social well being p value baseline to week 8||||0.22
72614816|NCT02583269|144759632|OTHER|||||||0.67|||||||ANOVA|||||||0.67
72614817|NCT02583269|144759633|OTHER|||||||0.119|||||||ANOVA|||Baseline v. 4 weeks log IL-8||||0.119
72614818|NCT02583269|144759633|OTHER|||||||0.414|||||||ANOVA|||Baseline v. 8 weeks log IL-8||||0.414
72614819|NCT02583269|144759634|OTHER|||||||0.851|||||||ANOVA|||Baseline v. 4 weeks p value log VEGF||||0.851
72614820|NCT02583269|144759634|OTHER|||||||0.688|||||||ANOVA|||Baseline vs. 8 weeks p value log VEGF||||0.688
72614821|NCT00876395|144759702|SUPERIORITY||Hazard Ratio (HR)|0.89||||0.1166|TWO_SIDED|95.0|0.73|1.08|||Log Rank|||||1.08|0.73|0.1166
72370935|NCT04518995|144251858|SUPERIORITY||LS Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001|TWO_SIDED|95.0|-1.1|-0.7||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||How Satisfied With Your Eyebrows: Week 16||-0.7|-1.1|< 0.0001
72370936|NCT04518995|144251858|SUPERIORITY||LS Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-1.4|-0.9||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||How Satisfied With Your Eyebrows: Week 16||-0.9|-1.4|< 0.0001
72370937|NCT04518995|144251858|SUPERIORITY||LS Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001|TWO_SIDED|95.0|-1.1|-0.7||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||How Satisfied With Your Eyebrows: Week 20||-0.7|-1.1|< 0.0001
72370938|NCT04518995|144251858|SUPERIORITY||LS Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-1.3|-0.9||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||How Satisfied With Your Eyebrows: Week 20||-0.9|-1.3|< 0.0001
72370939|NCT04518995|144251858|SUPERIORITY||LS Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001|TWO_SIDED|95.0|-1.2|-0.8||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||How Satisfied With Your Eyebrows: Week 24||-0.8|-1.2|< 0.0001
72370940|NCT04518995|144251858|SUPERIORITY||LS Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-1.4|-0.9||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||How Satisfied With Your Eyebrows: Week 24||-0.9|-1.4|< 0.0001
72370941|NCT04518995|144251858|SUPERIORITY||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001|TWO_SIDED|95.0|-0.7|-0.3||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||How Satisfied With Your Eyelashes: Week 12||-0.3|-0.7|< 0.0001
72370942|NCT04518995|144251858|SUPERIORITY||LS Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001|TWO_SIDED|95.0|-0.8|-0.4||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||How Satisfied With Your Eyelashes: Week 12||-0.4|-0.8|< 0.0001
72370943|NCT04518995|144251858|SUPERIORITY||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001|TWO_SIDED|95.0|-0.9|-0.5||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||How Satisfied With Your Eyelashes: Week 16||-0.5|-0.9|< 0.0001
72370944|NCT04518995|144251858|SUPERIORITY||LS Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-1.1|-0.7||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||How Satisfied With Your Eyelashes: Week 16||-0.7|-1.1|< 0.0001
72370945|NCT04518995|144251858|SUPERIORITY||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001|TWO_SIDED|95.0|-0.9|-0.5||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||How Satisfied With Your Eyelashes: Week 20||-0.5|-0.9|< 0.0001
72370946|NCT04518995|144251858|SUPERIORITY||LS Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-1.0|-0.5||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||How Satisfied With Your Eyelashes: Week 20||-0.5|-1.0|< 0.0001
72370947|NCT04518995|144251858|SUPERIORITY||LS Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-1.1|-0.6||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||How Satisfied With Your Eyelashes: Week 24||-0.6|-1.1|< 0.0001
72431878|NCT00689104|144375980|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.29||||0.01|TWO_SIDED|95.0|-0.61|0.03||The response variable for the stratified rank ANCOVA was standardized ranks on change from baseline to Final Visit value with baseline standardized ranks and gender as covariates and geographic region as a stratum.|Stratified rank ANCOVA|LS mean difference was derived from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.||Since there were 2 coprimary efficacy endpoints and 3 key secondary efficacy endpoints, the multiplicity among the endpoints was controlled at a type I error rate at the alpha = 0.05 level using a stepwise parallel gatekeeping procedure (5 stages). In addition, since two mirabegron treatment groups were compared with placebo per endpoint, the Hochberg procedure was used to adjust for multiplicity. A stratified rank ANCOVA model was utilized for hypothesis testing.||0.03|-0.61|0.010
72431879|NCT00689104|144375980|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.1||||0.11|TWO_SIDED|95.0|-0.42|0.21||The response variable for the stratified rank ANCOVA was standardized ranks on change from baseline to Final Visit value with baseline standardized ranks and gender as covariates and geographic region as a stratum.|Stratified rank ANCOVA|LS mean difference was derived from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate||Since the comparison between tolterodine and placebo was a secondary analysis, no adjustment for multiplicity was necessary.||0.21|-0.42|0.11
72553924|NCT03653507|144639957|SUPERIORITY||Hazard Ratio (HR)|0.781||||0.0826|TWO_SIDED|95.0|0.552|1.105|||Log Rank||Log-rank test stratified by:\* Region (Asia vs Non-Asia), \* Number of organs with metastatic sites (0 to 2 vs \>= 3), \* Prior gastrectomy (Yes or No)|||1.105|0.552|0.0826
72370948|NCT04518995|144251858|SUPERIORITY||LS Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-1.2|-0.7||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||How Satisfied With Your Eyelashes: Week 24||-0.7|-1.2|< 0.0001
72370949|NCT04518995|144251859|SUPERIORITY||LS Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|0.3||0.2489|TWO_SIDED|95.0|-0.2|0.9||P-value was calculated by analysis of covariance (ANCOVA) analysis with effects for treatment, visit, baseline SALT score, and baseline HADS value.|ANCOVA|||Anxiety||0.9|-0.2|0.2489
72370950|NCT04518995|144251859|SUPERIORITY||LS Mean Difference|0.5|STANDARD_ERROR_OF_MEAN|0.32||0.1235|TWO_SIDED|95.0|-0.1|1.1||P-value was calculated by ANCOVA analysis with effects for treatment, visit, baseline SALT score, and baseline HADS value.|ANCOVA|||Anxiety||1.1|-0.1|0.1235
72370951|NCT04518995|144251859|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.25||0.9765|TWO_SIDED|95.0|-0.5|0.5||P-value was calculated by ANCOVA analysis with effects for treatment, visit, baseline SALT score, and baseline HADS value.|ANCOVA|||Depression||0.5|-0.5|0.9765
72370952|NCT04518995|144251859|SUPERIORITY||LS Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|0.27||0.3559|TWO_SIDED|95.0|-0.3|0.8||P-value was calculated by ANCOVA analysis with effects for treatment, visit, baseline SALT score, and baseline HADS value.|ANCOVA|||Depression||0.8|-0.3|0.3559
72370953|NCT04518995|144251860|SUPERIORITY||Risk Difference (RD)|0.21|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001|TWO_SIDED|95.0|0.16|0.25||P-value was calculated by the Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||||0.25|0.16|<0.0001
72370954|NCT04518995|144251860|SUPERIORITY||Risk Difference (RD)|0.33|STANDARD_ERROR_OF_MEAN|0.032|<|0.0001|TWO_SIDED|95.0|0.27|0.39||P-value was calculated by the Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||||0.39|0.27|<0.0001
72370955|NCT04491604|144251872|EQUIVALENCE|The Hypothesis was tested by exact McNemar's test on the paired primary wound healing data.|responder rate difference|45.8||||0.00192|TWO_SIDED|95.0|23.6|68.0|||McNemar|The Hypothesis was tested by exact McNemar's test on the paired primary wound healing data. A multiple imputation approach was used for missing data.|The difference is the treatment/discordance difference in percentage of responders (primary wounds with complete healing), which is the same as the difference in the percentage of treatment responders and the percentage of placebo responders.|The null hypothesis of interest was the absence of a treatment effect on wound healing and the alternative hypothesis is the presence of a treatment effect on wound healing. The Hypothesis was tested by exact McNemar's test on the paired primary wound healing data. For subjects with missing primary wound healing data, a multiple imputation approach was used.||68.0|23.6|0.00192
72431880|NCT00689104|144375981|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.6|||<|0.001|TWO_SIDED|95.0|-0.9|-0.29||LS mean difference and p-value were derived from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|ANCOVA|||Since there were 2 coprimary efficacy endpoints and 3 key secondary efficacy endpoints, the multiplicity among the endpoints was controlled at a type I error rate at the alpha = 0.05 level using a stepwise parallel gatekeeping procedure (5 stages). In addition, since two mirabegron treatment groups were compared with placebo per endpoint, the Hochberg procedure was used to adjust for multiplicity. An ANCOVA model was used for hypothesis testing.||-0.29|-0.90|<0.001
72469367|NCT02402322|144462412|NON_INFERIORITY_OR_EQUIVALENCE|In the preliminary analysis, we studied the possible group differences in demographic data and pretreatment measures with chi-square tests and analysis of variance (ANOVA).||||||0.05|TWO_SIDED||||||ANOVA|||The participants' pre- and posttreatment scores were studied with repeated measures ANOVA. Within- and between-group effect sizes were calculated using the pooled standard deviation, Cohen's d.||||0.05
72493014|NCT01662440|144514793|NON_INFERIORITY_OR_EQUIVALENCE|The immune response of accelerated schedule of the Rabies vaccine considered non-inferior to the conventional schedule if the lower bound of the two-sided 97.5% Confidence Intervals (CI) of the difference in the percentages of subjects with RVNA titer ≥0.5 IU/mL measured 7 days after last active vaccination is greater than -5.|Difference in percentages of subjects|0.0|||||TWO_SIDED|97.5|-2.8|2.8||||||To establish non-inferiority of the immune response of Rabies vaccine (administered concomitantly with JE vaccine) accelerated schedule as compared to conventional schedule at 7 days after last active vaccination.||2.8|-2.8|
72493015|NCT01662440|144514794|NON_INFERIORITY_OR_EQUIVALENCE|The immune response of accelerated schedule of the JE vaccine is considered non-inferior to the conventional schedule if the lower bound of the two-sided 97.5% CI of the difference in the percentages of subjects with PRNT50 titer ≥1:10 measured 28 days after last active vaccination is greater than -10.|Difference in percentages of subjects|-1.0|||||TWO_SIDED|97.5|-4.8|7.9||||||Non-inferiority of the immune response of JE vaccine (administered concomitantly with Rabies vaccine) accelerated schedule as compared to conventional schedule at 28 day after last active vaccination||7.9|-4.8|
72553925|NCT02869867|144640003|SUPERIORITY||Mean Difference (Final Values)|3.2|||<|0.001|TWO_SIDED|95.0|2.09|4.31|||Mixed Models Analysis|||||4.31|2.09|<0.001
72553926|NCT04516967|144640007|SUPERIORITY|||||||0.0077|||||||Fisher Exact|||||||0.0077
72553927|NCT04516967|144640008|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||||||<0.0001
72370956|NCT04491604|144251873|EQUIVALENCE|The Hypothesis was tested by exact McNemar's test on the paired primary wound healing data.|responder rate difference|51.0||||0.00047|TWO_SIDED|95.0|29.3|72.6||There is no multiplicity adjustment needed since the hypothesis testing are hierarchical.|McNemar|The Hypothesis was tested by exact McNemar's test on the paired primary wound healing data. A multiple imputation approach was used for missing data.|The difference is the treatment/discordance difference in percentage of responders (complete wound healing), which is the same as the difference in the percentage of treatment responders and the percentage of placebo responders.|The null hypothesis of interest was the absence of a treatment effect on wound healing and the alternative hypothesis is the presence of a treatment effect on wound healing. The Hypothesis was tested by exact McNemar's test on the paired primary wound healing data. For subjects with missing primary wound healing data, a multiple imputation approach was used.||72.6|29.3|0.00047
72370957|NCT00373113|144251875|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.47||||0.002|TWO_SIDED|95.0|1.156|1.869||2-sided log-rank test with the same set of stratification factors. The set of stratification factors included those used in the randomization except study sites.|Log Rank||Hazard ratio was calculated by the stratified Cox proportional hazards model.|Null hypothesis is that PFS (median=4.2 months) for sunitinib arm equals PFS for capecitabine arm. The study was designed to have 90% power to detect statistical difference in PFS between two treatment groups assuming the hazard ratio (sunitinib/capecitabine) is 0.75 and both arms follow exponential distribution.||1.869|1.156|0.002
72370958|NCT00373113|144251876|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.516|||<|0.001|TWO_SIDED|95.0|1.188|1.933||2-sided log-rank test with the same set of stratification factors that was used in the randomization except study sites.|Log Rank||Hazard ratio was calculated by the stratified Cox proportional hazards model.|||1.933|1.188|<0.001
72370959|NCT00373113|144251877|SUPERIORITY_OR_OTHER||Objective Response Rate (ORR) (percent)|11.3|||||TWO_SIDED|95.0|7.6|16.1||||||||16.1|7.6|
72370960|NCT00373113|144251877|SUPERIORITY_OR_OTHER||Objective Response Rate (ORR) (percent)|16.4|||||TWO_SIDED|95.0|12.0|21.6||||||||21.6|12.0|
72370961|NCT00373113|144251877|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.049||||0.109|TWO_SIDED|95.0|-11.2|1.1|||Pearson Chi-Square Test|||||1.1|-11.2|0.109
72370962|NCT00373113|144251878|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.788||||0.037|TWO_SIDED|95.0|1.042|7.459|||Log Rank|||||7.459|1.042|0.037
72370963|NCT00373113|144251880|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.202||||0.219|TWO_SIDED|95.0|0.896|1.611||2-sided log-rank test with the same set of stratification factors that were used in the randomization except study sites.|Log Rank|||||1.611|0.896|0.219
72370964|NCT01305577|144251932|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.73|||<|0.001|TWO_SIDED|95.0|2.7|8.28|||Regression, Logistic|Logistic regression analysis with treatment and Baseline CR-SMFRS value in the model.|The odds ratio was based on a logistic regression model adjusted for the Baseline score. Odds ratios \>1 indicate a positive treatment effect.|"The null hypothesis was there was no difference between deoxycholic acid 1 mg/cm² and placebo.~An adjustment for multiplicity was performed for the two co-primary endpoints. This was accounted for by using the larger of the two P-values in the Bonferroni-Holm scheme."||8.28|2.70|<0.001
72370965|NCT01305577|144251932|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.21|||<|0.001|TWO_SIDED|95.0|3.52|10.94|||Regression, Logistic|Logistic regression analysis with treatment and Baseline CR-SMFRS value in the model.|The odds ratio was based on a logistic regression model adjusted for the Baseline score. Odds ratios \>1 indicate a positive treatment effect.|The null hypothesis was there was no difference between deoxycholic acid 2 mg/cm² and placebo. An adjustment for multiplicity was performed for the two co-primary endpoints. This was accounted for by using the larger of the two P-values in the Bonferroni-Holm scheme.||10.94|3.52|<0.001
72370966|NCT01305577|144251933|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.58||||0.028|TWO_SIDED|95.0|1.2|25.87|||Regression, Logistic|Logistic regression analysis with treatment and Baseline CR-SMFRS value in the model.|Odds ratio was based on a logistic regression model adjusted for the Baseline score. Odds ratios \>1 indicate a positive treatment effect.|||25.87|1.20|0.028
72504967|NCT01462292|144541155|SUPERIORITY_OR_OTHER||Mean Difference (Net)|27.099||||0.069|TWO_SIDED|95.0|-2.21|56.408||Due to the two comparisons for the two different doses, the type 1 error rate (5% overall) was preserved by utilising a hierarchical approach, testing the 6mg/kg GSK2402968 dose first|Mixed Model Repeated Measures|Model included terms for treatment, visit, treatment by visit, centre grouping, baseline and baseline by visit||Treatment difference: Placebo Vs GSK2402968 6 mg||56.408|-2.210|0.069
72614822|NCT00876395|144759703|SUPERIORITY||Hazard Ratio (HR)|0.66||||0.0049|TWO_SIDED|95.0|0.48|0.91|||Log Rank|||||0.91|0.48|0.0049
72614823|NCT00876395|144759706|SUPERIORITY|||||||0.7276|||||||Exact Cochran-Mantel-Haenzel chi-square|||||||0.7276
72614824|NCT00876395|144759707|SUPERIORITY|||||||0.4085|||||||Exact Cochran-Mantel-Haenzel chi-square|||||||0.4085
72370967|NCT01305577|144251933|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|12.05|||<|0.001|TWO_SIDED|95.0|2.75|52.9|||Regression, Logistic|Logistic regression analysis with treatment and Baseline CR-SMFRS value in the model.|Odds ratio was based on a logistic regression model adjusted for the Baseline score. Odds ratios \>1 indicate a positive treatment effect.|||52.90|2.75|<0.001
72370968|NCT01305577|144251934|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.99|||<|0.001|TWO_SIDED|95.0|1.74|5.14|||Regression, Logistic|Logistic regression analysis with treatment and Baseline SSRS value in the model|Odds ratio was based on a logistic regression model adjusted for Baseline score. Odds ratios \>1 indicate a positive treatment effect.|"The null hypothesis was there was no difference between deoxycholic acid 1 mg/cm² and placebo.~An adjustment for multiplicity was performed for the two co-primary endpoints. This was accounted for by using the larger of the two P-values in the Bonferroni-Holm scheme."||5.14|1.74|<0.001
72370969|NCT01305577|144251934|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.22|||<|0.001|TWO_SIDED|95.0|2.99|9.11|||Regression, Logistic|Logistic regression analysis with treatment and baseline SSRS value in the model|Odds ratio was based on a logistic regression model adjusted for Baseline score. Odds ratios \>1 indicate a positive treatment effect.|"The null hypothesis was there was no difference between deoxycholic acid 2 mg/cm² and placebo.~An adjustment for multiplicity was performed for the two co-primary endpoints. This was accounted for by using the larger of the two P-values in the Bonferroni-Holm scheme."||9.11|2.99|<0.001
72370970|NCT01305577|144251935|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.51|||<|0.001|TWO_SIDED|95.0|-0.68|-0.35|||Mixed Models Repeated Measures|The model included the fixed effect factors visit and treatment, the visit\*treatment interaction, and the baseline CR-SMFRS values as covariate.||||-0.35|-0.68|<0.001
72370971|NCT01305577|144251935|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.67|||<|0.001|TWO_SIDED|95.0|-0.84|-0.5|||Mixed Models Repeated Measures|The model included the fixed effect factors visit and treatment, the visit\*treatment interaction, and the baseline CR-SMFRS values as covariate.||||-0.50|-0.84|<0.001
72370972|NCT01305577|144251936|SUPERIORITY_OR_OTHER||LS Mean Difference|1.04|||<|0.001|TWO_SIDED|95.0|0.61|1.47|||ANCOVA|The model includes the fixed effect factor treatment and the Baseline values as covariate.||||1.47|0.61|<0.001
72370973|NCT01305577|144251936|SUPERIORITY_OR_OTHER||LS Mean Difference|1.41|||<|0.001|TWO_SIDED|95.0|0.99|1.84|||ANCOVA|The model includes the fixed effect factor treatment and the Baseline values as covariate.||||1.84|0.99|<0.001
72370974|NCT01305577|144251937|SUPERIORITY_OR_OTHER||LS mean Difference|-1.68|||<|0.001|TWO_SIDED|95.0|-2.5|-0.87|||Mixed Models Repeated Measures|The model includes the fixed effect factors visit and treatment, the visit\*treatment interaction, and the Baseline values as covariate.||||-0.87|-2.50|<0.001
72469368|NCT04593823|144462421|SUPERIORITY||Win Ratio|1.11|||||TWO_SIDED|95.0|0.48|2.5|||||A win ratio parameter signifies the percentage of wins that a treatment group has achieved when compared against a comparator.|||2.50|0.48|
72469369|NCT04593823|144462422|SUPERIORITY||Mean Difference (Final Values)|2.9|||>|0.999|TWO_SIDED|95.0|-17.0|15.9|||Chi-squared|||||15.9|-17.0|>0.999
72469370|NCT04593823|144462423|SUPERIORITY||Median Difference (Final Values)|-8.8||||0.459|TWO_SIDED|95.0|-36.4|13.6|||Chi-squared|||||13.6|-36.4|0.459
72469371|NCT04593823|144462425|SUPERIORITY||Least Squares Mean Difference|8.887||||0.547|TWO_SIDED|95.0|-20.01|37.784|||ANOVA|Repeated measures analysis||||37.784|-20.010|0.547
72469372|NCT04593823|144462426|SUPERIORITY|||||||0.336|||||||Wilcoxon (Mann-Whitney)|||||||0.336
72469373|NCT02472145|144462437|SUPERIORITY||Odds Ratio (OR)|1.5||||0.4747|TWO_SIDED|95.0|0.8|2.8|||Chi-squared|||Statistical Analysis 1||2.8|0.8|0.4747
72469374|NCT02472145|144462438|SUPERIORITY||Hazard Ratio (HR)|1.04||||0.7817|TWO_SIDED|95.0|0.79|1.37|||Log Rank|||Statistical Analysis 1||1.37|0.79|0.7817
72370975|NCT01305577|144251937|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.97|||<|0.001|TWO_SIDED|95.0|-2.79|-1.15|||Mixed Models Repeated Measures|The model includes the fixed effect factors visit and treatment, the visit\*treatment interaction, and the baseline values as covariate.||||-1.15|-2.79|<0.001
72370976|NCT01305577|144251938|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Pearson's chi-square test|||||||<0.001
72370977|NCT01305577|144251938|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Pearson's chi-square test|||||||<0.001
72370978|NCT02136069|144251958|SUPERIORITY||Adjusted Difference in Remission Rates|-0.9||||0.8114||95.0|-8.7|6.83|||Cochran-Mantel-Haenszel|||||6.83|-8.70|0.8114
72370979|NCT02136069|144251959|NON_INFERIORITY|with margin -12.5%|Adjusted Difference in Remission Rates|-12.0||||0.1293|TWO_SIDED|95.0|-20.5|-3.26||p-values are not multiplicity adjusted|Cochran-Mantel-Haenszel|A Farrington-Manning non-inferiority test was used to determine the nominal p-value.||||-3.26|-20.50|0.1293
72370980|NCT02136069|144251960|SUPERIORITY||Adjusted Difference in Remission Rates|-3.4||||0.4056|TWO_SIDED|95.0|-11.53|4.74||p-values are not multiplicity adjusted|Cochran-Mantel-Haenszel|||||4.74|-11.53|0.4056
72370981|NCT02136069|144251961|SUPERIORITY||Adjusted Difference in Remission Rates|-2.4||||0.4591|TWO_SIDED|95.0|-8.88|4.14||p-value has not been adjusted for multiplicity|Cochran-Mantel-Haenszel|||||4.14|-8.88|0.4591
72370982|NCT02136069|144251962|SUPERIORITY||Adjusted Difference in Remission Rates|5.3||||0.4196|TWO_SIDED|95.0|-7.54|18.13||p-value has not been adjusted for multiplicity|Cochran-Mantel-Haenszel|||||18.13|-7.54|0.4196
72553928|NCT04516967|144640009|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
72553929|NCT04516967|144640010|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||||||<0.0001
72370983|NCT02136069|144251963|SUPERIORITY||Adjusted Difference in Response Rates|-12.4||||0.0118|TWO_SIDED|95.0|-21.84|-2.66||p-value has not been adjusted for multiplicity|Cochran-Mantel-Haenszel|||||-2.66|-21.84|0.0118
72370984|NCT02136069|144251964|SUPERIORITY||Adjusted Difference in Response Rates|-4.9||||0.2845|TWO_SIDED|95.0|-13.76|4.12||p-value has not been adjusted for multiplicity|Cochran-Mantel-Haenszel|||||4.12|-13.76|0.2845
72370985|NCT02136069|144251965|SUPERIORITY||Adjusted Difference in Response Rates|-6.3||||0.1234|TWO_SIDED|95.0|-14.3|1.84||p-value has not been adjusted for multiplicity|Cochran-Mantel-Haenszel|||||1.84|-14.30|0.1234
72370986|NCT02136069|144251966|SUPERIORITY||Adjusted Difference in Remission Rates|-5.0||||0.2168|TWO_SIDED|95.0|-12.84|2.94||p-value has not been adjusted for multiplicity|Cochran-Mantel-Haenszel|||||2.94|-12.84|0.2168
72370987|NCT02136069|144251967|SUPERIORITY||Adjusted Difference in Response Rates|-9.5||||0.0564|TWO_SIDED|95.0|-19.06|0.29||p-value has not been adjusted for multiplicity|Cochran-Mantel-Haenszel|||||0.29|-19.06|0.0564
72370988|NCT02136069|144251968|SUPERIORITY||Adjusted Difference in Response Rates|-6.0||||0.1729|TWO_SIDED|95.0|-14.51|2.7||p-value has not been adjusted for multiplicity|Cochran-Mantel-Haenszel|||||2.70|-14.51|0.1729
72370989|NCT02136069|144251969|SUPERIORITY||Adjusted Difference in Remission Rates|-0.8||||0.8941|TWO_SIDED|95.0|-12.01|10.68||p-value has not been adjusted for multiplicity|Cochran-Mantel-Haenszel|||||10.68|-12.01|0.8941
72370990|NCT02136069|144251978|SUPERIORITY|Week 10|Difference in Adjusted Means|-3.1||||0.4106|TWO_SIDED|95.0|-10.6|4.3||p-value has not been adjusted for multiplicity|ANCOVA|||||4.3|-10.6|0.4106
72370991|NCT02136069|144251978|SUPERIORITY|Week 30|Difference in Adjusted Means|-5.7||||0.1434|TWO_SIDED|95.0|-13.3|1.9||p-value has not been adjusted for multiplicity|ANCOVA|||||1.9|-13.3|0.1434
72370992|NCT02136069|144251978|SUPERIORITY|Week 54|Difference in Adjusted Means|-6.1||||0.1103|TWO_SIDED|95.0|-13.6|1.4||p-value has not been adjusted for multiplicity|ANCOVA|||||1.4|-13.6|0.1103
72370993|NCT03328208|144251991|SUPERIORITY||Mean Difference (Final Values)|0.724|||<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<0.05
72370994|NCT03328208|144251992|SUPERIORITY||Mean Difference (Final Values)|0.038|||<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<0.05
72370995|NCT01247272|144252005|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|113.36|||||TWO_SIDED|90.0|108.03|118.96|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||118.96|108.03|
72370996|NCT01247272|144252006|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|107.78|||||TWO_SIDED|90.0|102.18|113.69|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||113.69|102.18|
72370997|NCT01247272|144252007|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|106.99|||||TWO_SIDED|90.0|102.09|112.12|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||112.12|102.09|
72469375|NCT01827046|144462460|SUPERIORITY||Risk Difference (RD)|2.0||||0.73|TWO_SIDED|95.0|-6.8|10.7|||Chi-squared|||||10.7|-6.8|0.73
72469376|NCT01827046|144462460|SUPERIORITY||Risk Difference (RD)|4.0||||0.33|TWO_SIDED|95.0|-4.0|12.0|||Multivariate logit model|||Adjusted for age, GCS, stability ICH volume, stability IVH volume, ICH deep location||12|-4|0.33
72469377|NCT01827046|144462461|SUPERIORITY||Risk Difference (RD)|0.03||||0.55|TWO_SIDED|95.0|-0.06|0.11|||Chi-squared|||||0.11|-0.06|0.55
72469378|NCT01827046|144462461|SUPERIORITY||Risk Difference (RD)|1.26||||0.27|TWO_SIDED|95.0|0.82|1.97|||Multivariate logit model|Adjusted for age, GCS, stability ICH volume, stability IVH volume and ICH deep location||||1.97|0.82|0.27
72469379|NCT01827046|144462462|SUPERIORITY|||||||0.08|TWO_SIDED|95.0|||||Log Rank|||||||0.08
72370998|NCT01247272|144252008|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|103.57|||||TWO_SIDED|90.0|99.54|107.76|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||107.76|99.54|
72370999|NCT01247272|144252009|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|105.8|||||TWO_SIDED|90.0|101.66|110.12|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||110.12|101.66|
72371000|NCT01247272|144252010|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|105.83|||||TWO_SIDED|90.0|101.27|110.61|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||110.61|101.27|
72371001|NCT00947882|144252013|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.3||||0.0911||||||P-value based on Williams' extended trend test of comparison vs. placebo at Month 3. No adjustment for multiple comparisons was made.|Step-down, Williams' extended trend test|Step-down procedure (starting with 30 mg vs. placebo) to identify the minimum effective dose. The step-down testing protects the type I error rate.|"Treatment difference between Degarelix 30 mg and Placebo at Month 3."|Analysis of Covariance (ANCOVA) of the change from baseline in IPSS at Month 3 in the FAS population using the Last Observation Carried Forward (LOCF) method, including the baseline IPSS as adjusting covariate and treatment group, prostate volume stratum (\<30 mL and ≥30 mL), and region (North America and Europe) as factors.||||0.0911
72371002|NCT00947882|144252013|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.44||||0.0865|TWO_SIDED|||||P-value based on Williams' extended trend test of comparison vs. placebo at Month 3. No adjustment for multiple comparisons was made.|Step-down, Williams' extended trend test|Step-down procedure (starting with 30 mg vs. placebo) to identify the minimum effective dose. The step-down testing protects the type I error rate.|"Treatment difference between Degarelix 20 mg and Placebo at Month 3."|Analysis of Covariance (ANCOVA) of the change from baseline in IPSS at Month 3 in the FAS population using the Last Observation Carried Forward (LOCF) method, including the baseline IPSS as adjusting covariate and treatment group, prostate volume stratum (\<30 mL and ≥30 mL), and region (North America and Europe) as factors.||||0.0865
72371003|NCT00947882|144252013|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.92||||0.2342||||||P-value based on Williams' extended trend test of comparison vs. placebo at Month 3. No adjustment for multiple comparisons was made.|Step-down, Williams' extended trend test|Step-down procedure (starting with 30 mg vs. placebo) to identify the minimum effective dose. The step-down testing protects the type I error rate.|"Treatment difference between Degarelix 10 mg and Placebo at Month 3."|Analysis of Covariance (ANCOVA) of the change from baseline in IPSS at Month 3 in the FAS population using the Last Observation Carried Forward (LOCF) method, including the baseline IPSS as adjusting covariate and treatment group, prostate volume stratum (\<30 mL and ≥30 mL), and region (North America and Europe) as factors.||||0.2342
72371004|NCT00947882|144252014|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.62||||0.0367||||||P-values based on Williams' extended trend test of comparison vs. placebo at Month 4. No adjustment for multiple comparisons was made.|Step-down, Williams' extended trend test|Step-down procedure (starting with 30 mg vs. placebo) to identify the minimum effective dose. The step-down testing protects the type I error rate.|"Treatment difference between Degarelix 30 mg and Placebo at Month 4."|ANCOVA of the change from baseline in IPSS at Months 4 in the FAS population using the LOCF method, including the baseline IPSS as adjusting covariate and treatment group, prostate volume stratum (\<30 mL and ≥30 mL), and region (North America and Europe) as factors.||||0.0367
72371005|NCT00947882|144252014|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.97||||0.0231||||||P-value based on Williams' extended trend test of comparison vs. placebo at Month 4. No adjustment for multiple comparisons was made.|Step-down, Williams' extended trend test|Step-down procedure (starting with 30 mg vs. placebo) to identify the minimum effective dose. The step-down testing protects the type I error rate.|"Treatment difference between Degarelix 20 mg and Placebo at Month 4."|ANCOVA of the change from baseline in IPSS at Month 4 in the FAS population using the LOCF method, including the baseline IPSS as adjusting covariate and treatment group, prostate volume stratum (\<30 mL and ≥30 mL), and region (North America and Europe) as factors.||||0.0231
72395046|NCT02700815|144296595|SUPERIORITY||Mean Difference (Net)|0.2|STANDARD_ERROR_OF_MEAN|0.223||0.3726|TWO_SIDED|95.0|-0.24|0.64|||Mixed Models Analysis||The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|A Mixed Model Repeat Measures (MMRM) analysis was used to compare change in POMwp from baseline between capsaicin and combination therapy diclofenac + capsaicin. MMRM model included fixed effects of treatment, country, application site (back/neck), time and fixed covariates of baseline POMwp and baseline POMwp by time interaction.||0.64|-0.24|0.3726
72469380|NCT01827046|144462462|SUPERIORITY||Cox Proportional Hazard|0.67||||0.037|TWO_SIDED|95.0|0.45|0.98|||Adjusted Cox proportional Hazard|Adjusted for age, GCS, Stability ICH volume, Stability IVH volume, ICH deep location, diabetes, cardiovascular disease and race.||||0.98|0.45|0.037
72469381|NCT01827046|144462463|SUPERIORITY||Odds Ratio (OR)|0.7|||<|0.001|TWO_SIDED|95.0|0.62|0.8|||Logit model|||||0.80|0.62|<0.001
72553930|NCT04516967|144640011|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
72614825|NCT00876395|144759708|SUPERIORITY|||||||0.9573|||||||Exact Cochran-Mantel-Haenzel chi-square|||||||0.9573
72553931|NCT04516967|144640012|SUPERIORITY|||||||0.0008|||||||Fisher Exact|||||||0.0008
72614826|NCT00876395|144759709|SUPERIORITY|||||||0.6382|||||||Exact Cochran-Mantel-Haenzel chi-square|||||||0.6382
72371006|NCT00947882|144252014|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.11||||0.1638||||||P-value based on Williams' extended trend test of comparison vs. placebo at Month 4. No adjustment for multiple comparisons was made.|Step-down, Williams' extended trend test|Step-down procedure (starting with 30 mg vs. placebo) to identify the minimum effective dose. The step-down testing protects the type I error rate.|"Treatment difference between Degarelix 10 mg and Placebo at Month 4."|ANCOVA of the change from baseline in IPSS at Month 4 in the FAS population using the LOCF method, including the baseline IPSS as adjusting covariate and treatment group, prostate volume stratum (\<30 mL and ≥30 mL), and region (North America and Europe) as factors.||||0.1638
72371007|NCT00947882|144252014|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.14||||0.1941||||||P-values based on Williams' extended trend test of comparisons vs. placebo at Month 5. No adjustment for multiple comparison was made.|Step-down, Williams' extended trend test|Step-down procedure (starting with 30 mg vs. placebo) to identify the minimum effective dose. The step-down testing protects the type I error rate.|"Treatment difference between Degarelix 30 mg and Placebo at Month 5."|ANCOVA of the change from baseline in IPSS at Month 5 in the FAS population using the LOCF method, including the baseline IPSS as adjusting covariate and treatment group, prostate volume stratum (\<30 mL and ≥30 mL), and region (North America and Europe) as factors.||||0.1941
72371008|NCT00947882|144252014|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.54||||0.1083||||||P-value based on Williams' extended trend test of comparison vs. placebo at Month 5. No adjustment for multiple comparisons was made.|Step-down, Williams' extended trend test|Step-down procedure (starting with 30 mg vs. placebo) to identify the minimum effective dose. The step-down testing protects the type I error rate.|"Treatment difference between Degarelix 20 mg and Placebo at Month 5."|ANCOVA of the change from baseline in IPSS at Month 5 in the FAS population using the LOCF method, including the baseline IPSS as adjusting covariate and treatment group, prostate volume stratum (\<30 mL and ≥30 mL), and region (North America and Europe) as factors.||||0.1083
72371009|NCT00947882|144252014|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.95||||0.2782||||||P-value based on Williams' extended trend test of comparison vs. placebo at Month 5. No adjustment for multiple comparisons was made.|Step-down, Williams' extended trend test|Step-down procedure (starting with 30 mg vs. placebo) to identify the minimum effective dose. The step-down testing protects the type I error rate.|"Treatment difference between Degarelix 10 mg and Placebo at Month 5."|ANCOVA of the change from baseline in IPSS at Month 5 in the FAS population using the LOCF method, including the baseline IPSS as adjusting covariate and treatment group, prostate volume stratum (\<30 mL and ≥30 mL), and region (North America and Europe) as factors.||||0.2782
72371010|NCT00947882|144252014|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.15||||0.1562||||||P-values based on Williams' extended trend test of comparison vs. placebo at Month 6. No adjustment for multiple comparisons was made.|Step-down, Williams' extended trend test|Step-down procedure (starting with 30 mg vs. placebo) to identify the minimum effective dose. The step-down testing protects the type I error rate.|"Treatment difference between Degarelix 30 mg and Placebo at Month 6."|ANCOVA of the change from baseline in IPSS at Month 6 in the FAS population using the LOCF method, including the baseline IPSS as adjusting covariate and treatment group, prostate volume stratum (\<30 mL and ≥30 mL), and region (North America and Europe) as factors.||||0.1562
72371011|NCT00947882|144252014|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.24||||0.1736||||||P-value based on Williams' extended trend test of comparison vs. placebo at Month 6. No adjustment for multiple comparisons was made.|Step-down, Williams' extended trend test|Step-down procedure (starting with 30 mg vs. placebo) to identify the minimum effective dose. The step-down testing protects the type I error rate.|"Treatment difference between Degarelix 20 mg and Placebo at Month 6."|ANCOVA of the change from baseline in IPSS at Month 6 in the FAS population using the LOCF method, including the baseline IPSS as adjusting covariate and treatment group, prostate volume stratum (\<30 mL and ≥30 mL), and region (North America and Europe) as factors.||||0.1736
72431881|NCT00689104|144375981|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.44||||0.005|TWO_SIDED|95.0|-0.74|-0.13||LS mean difference and p-value were derived from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|ANCOVA|||Since there were 2 coprimary efficacy endpoints and 3 key secondary efficacy endpoints, the multiplicity among the endpoints was controlled at a type I error rate at the alpha = 0.05 level using a stepwise parallel gatekeeping procedure (5 stages). In addition, since two mirabegron treatment groups were compared with placebo per endpoint, the Hochberg procedure was used to adjust for multiplicity. An ANCOVA model was used for hypothesis testing.||-0.13|-0.74|0.005
72431882|NCT00689104|144375981|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.25||||0.11|TWO_SIDED|95.0|-0.55|0.06||LS mean difference and p-value were derived from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|ANCOVA|||Since the comparison between tolterodine and placebo was a secondary analysis, no adjustment for multiplicity was necessary.||0.06|-0.55|0.11
72431883|NCT00689104|144375982|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|11.9|||<|0.001|TWO_SIDED|95.0|6.3|17.4||LS mean difference and p-value were derived from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|ANCOVA|||Since there were 2 coprimary efficacy endpoints and 3 key secondary efficacy endpoints, the multiplicity among the endpoints was controlled at a type I error rate at the alpha = 0.05 level using a stepwise parallel gatekeeping procedure (5 stages). In addition, since two mirabegron treatment groups were compared with placebo per endpoint, the Hochberg procedure was used to adjust for multiplicity. An ANCOVA model was used for hypothesis testing.||17.4|6.3|<0.001
72431884|NCT00689104|144375982|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|13.2|||<|0.001|TWO_SIDED|95.0|7.7|18.7||LS mean difference and p-value were derived from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate|ANCOVA|||Since there were 2 coprimary efficacy endpoints and 3 key secondary efficacy endpoints, the multiplicity among the endpoints was controlled at a type I error rate at the alpha = 0.05 level using a stepwise parallel gatekeeping procedure (5 stages). In addition, since two mirabegron treatment groups were compared with placebo per endpoint, the Hochberg procedure was used to adjust for multiplicity. An ANCOVA model was used for hypothesis testing.||18.7|7.7|<0.001
72469382|NCT01827046|144462463|SUPERIORITY||Odds Ratio (OR)|0.68|||<|0.001|TWO_SIDED|95.0|0.59|0.78|||Multivariate logit model|Adjusted for age, GCS, stability IVH volume, and ICH deep location||||0.78|0.59|<0.001
72469383|NCT01827046|144462464|SUPERIORITY|||||||0.78|||||||Wilcoxon (Mann-Whitney)|||||||0.78
72431885|NCT00689104|144375982|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|12.6|||<|0.001|TWO_SIDED|95.0|7.1|18.2||LS mean difference and p-value were derived from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|ANCOVA|||Since the comparison between tolterodine and placebo was a secondary analysis, no adjustment for multiplicity was necessary.||18.2|7.1|<0.001
72371012|NCT00947882|144252014|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.84||||0.3132||||||P-value based on Williams' extended trend test of comparison vs. placebo at Month 6. No adjustment for multiple comparisons was made.|Step-down, Williams' extended trend test|Step-down procedure (starting with 30 mg vs. placebo) to identify the minimum effective dose. The step-down testing protects the type I error rate.|"Treatment difference between Degarelix 10 mg and Placebo at Month 6."|ANCOVA of the change from baseline in IPSS at Month 6 in the FAS population using the LOCF method, including the baseline IPSS as adjusting covariate and treatment group, prostate volume stratum (\<30 mL and ≥30 mL), and region (North America and Europe) as factors.||||0.3132
72371013|NCT00947882|144252015|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.46||||0.2034|TWO_SIDED|95.0|0.814|2.628||"Adjustments were made for treatment group, baseline IPSS, graphical region (North America and Europe) and baseline prostate size (\<30 mL and ≥30 mL).~Unadjusted p-value of comparison vs. placebo at Month 3."|Regression, Logistic|No adjustment for multiple comparisons was made. LOCF.|"Odds ratio of treatment response between Degarelix 30 mg and Placebo at Month 3."|||2.628|0.814|0.2034
72371014|NCT00947882|144252015|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.5||||0.1748|TWO_SIDED|95.0|0.834|2.71||"Adjustments were made for treatment group, baseline IPSS, graphical region (North America and Europe) and baseline prostate size (\<30 mL and ≥30 mL).~Unadjusted p-value of comparison vs. placebo at Month 3."|Regression, Logistic|No adjustment for multiple comparisons was made. LOCF.|"Odds ratio of treatment response between Degarelix 20 mg and Placebo at Month 3."|||2.710|0.834|0.1748
72371015|NCT00947882|144252015|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.75||||0.0658|TWO_SIDED|95.0|0.964|3.195||"Adjustments were made for treatment group, baseline IPSS, graphical region (North America and Europe) and baseline prostate size (\<30 mL and ≥30 mL).~Unadjusted p-value of comparison vs. placebo at Month 3."|Regression, Logistic|No adjustment for multiple comparisons was made. LOCF.|"Odds ratio of treatment response between Degarelix 10 mg and Placebo at Month 3."|||3.195|0.964|0.0658
72371016|NCT00947882|144252015|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.77||||0.0587|TWO_SIDED|95.0|0.979|3.184||"Adjustments were made for treatment group, baseline IPSS, graphical region (North America and Europe) and baseline prostate size (\<30 mL and ≥30 mL).~Unadjusted p-value of comparison vs. placebo at Month 4."|Regression, Logistic|No adjustment for multiple comparisons was made. LOCF.|"Odds ratio of treatment response between Degarelix 30 mg and Placebo at Month 4."|||3.184|0.979|0.0587
72371017|NCT00947882|144252015|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.81||||0.049|TWO_SIDED|95.0|1.003|3.283||"Adjustments were made for treatment group, baseline IPSS, graphical region (North America and Europe) and baseline prostate size (\<30 mL and ≥30 mL).~Unadjusted p-value of comparison vs. placebo at Month 4."|Regression, Logistic|No adjustment for multiple comparisons was made. LOCF.|"Odds ratio of treatment response between Degarelix 20 mg and Placebo at Month 4."|||3.283|1.003|0.0490
72371018|NCT00947882|144252015|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.38||||0.2742|TWO_SIDED|95.0|0.774|2.464||"Adjustments were made for treatment group, baseline IPSS, graphical region (North America and Europe) and baseline prostate size (\<30 mL and ≥30 mL).~Unadjusted p-value of comparison vs. placebo at Month 4."|Regression, Logistic|No adjustment for multiple comparisons was made. LOCF.|"Odds ratio of treatment response between Degarelix 10 mg and Placebo at Month 4."|||2.464|0.774|0.2742
72371019|NCT00947882|144252015|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.28||||0.4206|TWO_SIDED|95.0|0.706|2.304||"Adjustments were made for treatment group, baseline IPSS, graphical region (North America and Europe) and baseline prostate size (\<30 mL and ≥30 mL).~Unadjusted p-value of comparison vs. placebo at Month 5."|Regression, Logistic|No adjustment for multiple comparisons was made. LOCF.|"Odds ratio of treatment response between Degarelix 30 mg and Placebo at Month 5."|||2.304|0.706|0.4206
72371020|NCT00947882|144252015|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.2||||0.5494|TWO_SIDED|95.0|0.664|2.16||"Adjustments were made for treatment group, baseline IPSS, graphical region (North America and Europe) and baseline prostate size (\<30 mL and ≥30 mL).~Unadjusted p-value of comparison vs. placebo at Month 5."|Regression, Logistic|No adjustment for multiple comparisons was made. LOCF.|"Odds ratio of treatment response between Degarelix 20 mg and Placebo at Month 5."|||2.160|0.664|0.5494
72371021|NCT00947882|144252015|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.1||||0.7586|TWO_SIDED|95.0|0.609|1.975||"Adjustments were made for treatment group, baseline IPSS, graphical region (North America and Europe) and baseline prostate size (\<30 mL and ≥30 mL).~Unadjusted p-value of comparison vs. placebo at Month 5."|Regression, Logistic|No adjustment for multiple comparisons was made. LOCF.|"Odds ratio of treatment response between Degarelix 10 mg and Placebo at Month 5."|||1.975|0.609|0.7586
72371022|NCT00947882|144252015|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.49||||0.1946|TWO_SIDED|95.0|0.816|2.717||"Adjustments were made for treatment group, baseline IPSS, graphical region (North America and Europe) and baseline prostate size (\<30 mL and ≥30 mL).~Unadjusted p-value of comparison vs. placebo at Month 6."|Regression, Logistic|No adjustment for multiple comparisons was made. LOCF.|"Odds ratio of treatment response between Degarelix 30 mg and Placebo at Month 6."|||2.717|0.816|0.1946
72371023|NCT00947882|144252015|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.2||||0.538|TWO_SIDED|95.0|0.667|2.174||"Adjustments were made for treatment group, baseline IPSS, graphical region (North America and Europe) and baseline prostate size (\<30 mL and ≥30 mL).~Unadjusted p-value of comparison vs. placebo at Month 6."|Regression, Logistic|No adjustment for multiple comparisons was made. LOCF.|"Odds ratio of treatment response between Degarelix 20 mg and Placebo at Month 6."|||2.174|0.667|0.5380
72469384|NCT01827046|144462465|SUPERIORITY||Risk Difference (RD)|0.04||||0.34|TWO_SIDED|95.0|-0.04|0.11|||Chi-squared|||||0.11|-0.04|0.34
72469385|NCT01827046|144462466|SUPERIORITY||Risk Difference (RD)|-0.01||||0.76|TWO_SIDED|95.0|-0.1|0.07|||Chi-squared|||||0.07|-0.10|0.76
72504415|NCT01855789|144539435|SUPERIORITY||DAS28 Worsening Rate Difference|7.5||||0.2371|TWO_SIDED|95.0|-2.4|17.3|||Cochran-Mantel-Haenszel||TCZ + PBO minus TCZ + MTX|Week 40: Analysis of association between treatment group and worsening in DAS28, stratified by the randomization stratification factors: DAS28 remission status at Week 24 (\<2.6, \>=2.6 to \<=3.2), baseline weight-by-dosing group (\<80 kg q2w, \<80 kg qw, 80-\<100 kg q2w, 80-\<100 kg qw, \>=100 kg qw), participant anti-TNF exposure (Yes/No).||17.3|-2.4|0.2371
72431886|NCT00689104|144375983|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.39||||0.002|TWO_SIDED|95.0|-0.71|-0.06||The response variable for the stratified rank ANCOVA was standardized ranks on change from baseline to Final Visit value with baseline standardized ranks and gender as covariates and geographic region as a stratum.|Stratified rank ANCOVA|LS mean difference was derived from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.||Since there were 2 coprimary efficacy endpoints and 3 key secondary efficacy endpoints, the multiplicity among the endpoints was controlled at a type I error rate at the alpha = 0.05 level using a stepwise parallel gatekeeping procedure (5 stages). In addition, since two mirabegron treatment groups were compared with placebo per endpoint, the Hochberg procedure was used to adjust for multiplicity. A stratified rank ANCOVA model was utilized for hypothesis testing.||-0.06|-0.71|0.002
72614827|NCT03807843|144759720|OTHER||V184 GMFR/Placebo GMFR Ratio|1.6||||0.004|TWO_SIDED|95.0|1.2|2.1|||Mixed Effects Model|||"Day 28 V184 GMFR/Placebo GMFR Ratio~The ratio of V184 GMFR/Placebo GMFR at Day 28 was derived from the mixed effects model used to determine GMFR."||2.1|1.2|0.004
72371024|NCT00947882|144252015|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.27||||0.4263|TWO_SIDED|95.0|0.702|2.308||"Adjustments were made for treatment group, baseline IPSS, graphical region (North America and Europe) and baseline prostate size (\<30 mL and ≥30 mL).~Unadjusted p-value of comparison vs. placebo at Month 6."|Regression, Logistic|No adjustment for multiple comparisons was made. LOCF.|"Odds ratio of treatment response between Degarelix 10 mg and Placebo at Month 6."|||2.308|0.702|0.4263
72371025|NCT00947882|144252016|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.76||||0.4607|TWO_SIDED|95.0|-10.113|4.59||No adjustment for multiple comparisons was made. Unadjusted p-value of comparison vs. placebo at Month 3.|ANCOVA|ANCOVA with baseline TPV as covariate and treatment group, region (North America,Europe) and prostate volume stratum (\<30 mL,≥30 mL) as factors. LOCF.|"Treatment difference between Degarelix 30 mg and Placebo at Month 3."|||4.590|-10.113|0.4607
72371026|NCT00947882|144252016|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.24||||0.3876|TWO_SIDED|95.0|-10.614|4.128||No adjustment for multiple comparisons was made. Unadjusted p-value of comparison vs. placebo at Month 3.|ANCOVA|ANCOVA with baseline TPV as covariate and treatment group, region (North America,Europe) and prostate volume stratum (\<30 mL,≥30 mL) as factors. LOCF.|"Treatment difference between Degarelix 20 mg and Placebo at Month 3."|||4.128|-10.614|0.3876
72371027|NCT00947882|144252016|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.28||||0.2548|TWO_SIDED|95.0|-11.65|3.096||No adjustment for multiple comparisons was made. Unadjusted p-value of comparison vs. placebo at Month 3.|ANCOVA|ANCOVA with baseline TPV as covariate and treatment group, region (North America,Europe) and prostate volume stratum (\<30 mL,≥30 mL) as factors. LOCF.|"Treatment difference between Degarelix 10 mg and Placebo at Month 3."|||3.096|-11.650|0.2548
72371028|NCT00947882|144252016|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.2||||0.5652|TWO_SIDED|95.0|-9.729|5.322||No adjustment for multiple comparisons was made. Unadjusted p-value of comparison vs. placebo at Month 6.|ANCOVA|ANCOVA with baseline TPV as covariate and treatment group, region (North America,Europe) and prostate volume stratum (\<30 mL,≥30 mL) as factors. LOCF.|"Treatment difference between Degarelix 30 mg and Placebo at Month 6."|||5.322|-9.729|0.5652
72371029|NCT00947882|144252016|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.22||||0.7502|TWO_SIDED|95.0|-8.768|6.322||No adjustment for multiple comparisons was made. Unadjusted p-value of comparison vs. placebo at Month 6.|ANCOVA|ANCOVA with baseline TPV as covariate and treatment group, region (North America,Europe) and prostate volume stratum (\<30 mL,≥30 mL) as factors. LOCF.|"Treatment difference between Degarelix 20 mg and Placebo at Month 6."|||6.322|-8.768|0.7502
72371030|NCT00947882|144252016|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.97||||0.6089|TWO_SIDED|95.0|-9.513|5.581||No adjustment for multiple comparisons was made. Unadjusted p-value of comparison vs. placebo at Month 6.|ANCOVA|ANCOVA with baseline TPV as covariate and treatment group, region (North America,Europe) and prostate volume stratum (\<30 mL,≥30 mL) as factors. LOCF.|"Treatment difference between Degarelix 10 mg and Placebo at Month 6."|||5.581|-9.513|0.6089
72371031|NCT00947882|144252017|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.11||||0.8511|TWO_SIDED|95.0|-1.068|1.294||No adjustment for multiple comparisons was made. Unadjusted p-value of comparison vs. placebo at Month 3.|ANCOVA|ANCOVA with baseline Qmax as covariate and treatment group, region (North America,Europe) and prostate volume stratum (\<30 mL,≥30 mL) as factors.LOCF.|"Treatment difference between Degarelix 30 mg and Placebo at Month 3."|||1.294|-1.068|0.8511
72371032|NCT00947882|144252017|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.29||||0.6331|TWO_SIDED|95.0|-0.9|1.477||No adjustment for multiple comparisons was made. Unadjusted p-value of comparison vs. placebo at Month 3.|ANCOVA|ANCOVA with baseline Qmax as covariate and treatment group, region (North America,Europe) and prostate volume stratum (\<30 mL,≥30 mL) as factors.LOCF.|"Treatment difference between Degarelix 20 mg and Placebo at Month 3."|||1.477|-0.900|0.6331
72371033|NCT00947882|144252017|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.07||||0.909|TWO_SIDED|95.0|-1.113|1.25||No adjustment for multiple comparisons was made. Unadjusted p-value of comparison vs. placebo at Month 3.|ANCOVA|ANCOVA with baseline Qmax as covariate and treatment group, region (North America,Europe) and prostate volume stratum (\<30 mL,≥30 mL) as factors.LOCF.|"Treatment difference between Degarelix 10 mg and Placebo at Month 3."|||1.250|-1.113|0.9090
72469386|NCT01827046|144462466|SUPERIORITY||Odds Ratio (OR)|1.25||||0.31|TWO_SIDED|95.0|0.81|1.94|||Multivariate logit model|Adjusted for age, GCS, Stability ICH volume, Stability IVH volume, ICH deep location||||1.94|0.81|0.31
72371034|NCT00947882|144252017|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.42||||0.5469|TWO_SIDED|95.0|-0.956|1.802||No adjustment for multiple comparisons was made. Unadjusted p-value of comparison vs. placebo at Month 6.|ANCOVA|ANCOVA with baseline Qmax as covariate and treatment group, region (North America,Europe) and prostate volume stratum (\<30 mL,≥30 mL) as factors.LOCF.|"Treatment difference between Degarelix 30 mg and Placebo at Month 6."|||1.802|-0.956|0.5469
72469387|NCT01827046|144462467|SUPERIORITY||Risk Difference (RD)|0.01||||0.79|TWO_SIDED|95.0|-0.07|0.09|||Chi-squared|||||0.09|-0.07|0.79
72469388|NCT01827046|144462467|SUPERIORITY||Odds Ratio (OR)|1.24||||0.35|TWO_SIDED|95.0|0.79|1.97|||Multivariate logit model|Adjusted for age, GCS, Stability ICH volume, Stability IVH volume, ICH deep location||||1.97|0.79|0.35
72469389|NCT01827046|144462468|SUPERIORITY|||||||0.46|||||||Median test|||||||0.46
72493016|NCT01662440|144514795|NON_INFERIORITY_OR_EQUIVALENCE|The conventional schedule of Rabies vaccine co-administered with JE vaccine considered non inferior to the conventional schedule of Rabies vaccine administered alone if the lower bound of the two-sided 95% CI of the ratio of GMCs measured 28 days after last active vaccination is greater than 0.667.|Between groups ratio of GMCs|1.07|||||TWO_SIDED|95.0|0.86|1.32||||||Non-inferiority of the immune response of Rabies vaccine (administered concomitantly with JE vaccine) as compared to Rabies vaccines (administered alone) as given according to conventional schedule at 28day after last active vaccination||1.32|0.86|
72493017|NCT01662440|144514796|NON_INFERIORITY_OR_EQUIVALENCE|The conventional schedule of JE vaccine co-administered with Rabies vaccine considered non inferior to the conventional schedule of JE vaccine administered alone if the lower bound of the two-sided 95% CI of the ratio of GMTs measured 28 days after last active vaccination is greater than 0.5.|Ratio of GMTs|0.88|||||TWO_SIDED|95.0|0.68|1.13||||||Non-inferiority of the immune response of JE vaccine (administered concomitantly with Rabies vaccine) as compared to JE vaccine (administered alone) as given according to conventional schedule at day 28 after last active vaccination.||1.13|0.68|
72493018|NCT01662440|144514797|NON_INFERIORITY_OR_EQUIVALENCE|The immune response of accelerated schedule of the Rabies vaccine is considered non-inferior to the Rabies vaccine conventional schedule if the lower bound of the two-sided 95% CI of the difference in the percentages of subjects with RVNA titer ≥0.5 IU/mL measured 28 days after last active vaccine administration is greater than -5.|Difference in percentages of subjects|-1.0|||||TWO_SIDED|95.0|-3.8|1.4||||||Non-inferiority of the Rabies immune response (administered concomitantly with JE vaccine) as given according to an accelerated schedule as compared Rabies vaccine (administered alone) as given to a conventional schedule at day 28 after last active vaccination||1.4|-3.8|
72371035|NCT00947882|144252017|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.19||||0.7906|TWO_SIDED|95.0|-1.576|1.2||No adjustment for multiple comparisons was made. Unadjusted p-value of comparison vs. placebo at Month 6.|ANCOVA|ANCOVA with baseline Qmax as covariate and treatment group, region (North America,Europe) and prostate volume stratum (\<30 mL,≥30 mL) as factors.LOCF.|"Treatment difference between Degarelix 20 mg and Placebo at Month 6."|||1.200|-1.576|0.7906
72371036|NCT00947882|144252017|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.39||||0.5757|TWO_SIDED|95.0|-1.773|0.987||No adjustment for multiple comparisons was made. Unadjusted p-value of comparison vs. placebo at Month 6.|ANCOVA|ANCOVA with baseline Qmax as covariate and treatment group, region (North America,Europe) and prostate volume stratum (\<30 mL,≥30 mL) as factors.LOCF.|"Treatment difference between Degarelix 10 mg and Placebo at Month 6."|||0.987|-1.773|0.5757
72493019|NCT01662440|144514798|NON_INFERIORITY_OR_EQUIVALENCE|The immune response of accelerated schedule of the JE vaccine considered non-inferior to the conventional schedule if the lower bound of the two-sided 95% CI of the difference in the percentages of subjects with PRNT50 titer ≥1:10 measured 7 days after last active vaccine administration is greater than -10.|Difference in percentages of subjects|-1.0|||||TWO_SIDED|95.0|-4.1|6.2||||||Non-inferiority of the immune response of JE vaccine (administered concomitantly with Rabies vaccine) as given according to an accelerated schedule as compared to JE vaccine (administered alone) as given according to a conventional schedule at 7day after last active vaccine administration.||6.2|-4.1|
72493020|NCT00691483|144514813|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.03|||<|0.0001|TWO_SIDED|95.0|3.8|9.56||To preserve the type I family-wise error rate of 0.05, a step-down procedure to be used for the analysis of CA for Week 9 through Week 12 and the CA for Week 9 through Week 24.|Regression, Logistic|Model to include the main effects of treatment and pooled center.||Sample size to be based on a continuity-corrected Chi-square 2-sided test with a 0.05 significance level and a 3:1 randomization ratio of Varenicline to placebo. 652 subjects to provide \>=90% power to detect Varenicline versus placebo differences in primary and key secondary efficacy endpoints (assuming placebo CA rates of 0.24 \[Weeks 9-12\] and 0.18 \[Weeks 9-24\] and Varenicline CA rates of 0.46 \[Weeks 9-12\] and 0.31 \[Weeks 9-24\]) (odds ratio of \>=2.67 \[Weeks 9-12\] and \>=2.10 \[Weeks 9-24\]).||9.56|3.80|<0.0001
72371037|NCT00329797|144252018|SUPERIORITY|||||||0.95|||||||Log Rank|||The study is designed to show a 40% relative reduction in the yearly ABF hazard rate, equivalent to an improvement in a 3-year FABF rate from 88% to 92.6%. A sample size of 1030 analyzable patients with a one-sided log-rank test at α = 0.05, was calculated to provide 80% statistical power, with one interim analysis and a final analysis for efficacy using Haybittle-Peto boundaries.||||0.95
72504416|NCT01855789|144539435|SUPERIORITY||DAS28 Worsening Rate Difference|3.4||||0.4811|TWO_SIDED|95.0|-6.9|13.7|||Cochran-Mantel-Haenszel||TCZ + PBO minus TCZ + MTX|Week 52: Analysis of association between treatment group and worsening in DAS28, stratified by the randomization stratification factors: DAS28 remission status at Week 24 (\<2.6, \>=2.6 to \<=3.2), baseline weight-by-dosing group (\<80 kg q2w, \<80 kg qw, 80-\<100 kg q2w, 80-\<100 kg qw, \>=100 kg qw), participant anti-TNF exposure (Yes/No).||13.7|-6.9|0.4811
72614828|NCT03807843|144759720|OTHER||V184 GMFR/Placebo GMFR Ratio|2.1|||<|0.001|TWO_SIDED|95.0|1.5|2.8|||Mixed Effects Model|||"Day 56 V184 GMFR/Placebo GMFR Ratio~The ratio of V184 GMFR/Placebo GMFR at Day 56 was derived from the mixed effects model used to determine GMFR."||2.8|1.5|<0.001
72371038|NCT00329797|144252019|SUPERIORITY||||||<|0.0001||||||significance level = 0.05|t-test, 2 sided|||Lumbar||||<0.0001
72371039|NCT00329797|144252019|SUPERIORITY|||||||0.47||||||significance level = 0.05|t-test, 2 sided|||Hip - right||||0.47
72469390|NCT01827046|144462469|SUPERIORITY|||||||0.75|||||||Median test|||||||0.75
72371040|NCT00329797|144252019|SUPERIORITY|||||||0.0002||||||significance level = 0.05|t-test, 2 sided|||Hip - left||||0.0002
72371041|NCT00329797|144252019|SUPERIORITY|||||||0.076||||||significance level = 0.05|t-test, 2 sided|||Femoral - right||||0.076
72469391|NCT01827046|144462470|SUPERIORITY|||||||0.66|||||||Wilcoxon (Mann-Whitney)|||||||0.66
72469392|NCT01827046|144462471|SUPERIORITY|||||||0.87|||||||Chi-squared|||||||0.87
72469393|NCT01827046|144462472|SUPERIORITY|||||||0.02|||||||Chi-squared|||||||0.02
72371042|NCT00329797|144252019|SUPERIORITY|||||||0.0007||||||significance level = 0.05|t-test, 2 sided|||Femoral - left||||0.0007
72469394|NCT01827046|144462473|SUPERIORITY|||||||0.05|||||||Chi-squared|||||||0.05
72469395|NCT01827046|144462474|SUPERIORITY|||||||0.32|||||||Chi-squared|||||||0.32
72469396|NCT01827046|144462475|SUPERIORITY|||||||0.16|||||||Chi-squared|||||||0.16
72504968|NCT01462292|144541156|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.387||||0.699|TWO_SIDED|95.0|-1.618|2.392||No adjustment for multiplicity was made, so p-values should not be used to make conclusions with regards to statistical significance|ANCOVA|Model included terms for treatment, centre grouping and baseline||Treatment difference: Placebo Vs GSK2402968 3 mg||2.392|-1.618|0.699
72614829|NCT03807843|144759720|OTHER||V184 GMFR/Placebo GMFR Ratio|1.3||||0.121|TWO_SIDED|95.0|0.9|1.7|||Mixed Effects Model|||"Day 196 V184 GMFR/Placebo GMFR Ratio~The ratio of V184 GMFR/Placebo GMFR at Day 196 was derived from the mixed effects model used to determine GMFR."||1.7|0.9|0.121
72371043|NCT00329797|144252020|SUPERIORITY|||||||0.33||||||significance level = 0.01|t-test, 2 sided|||Physical subscale||||0.33
72371044|NCT00329797|144252020|SUPERIORITY|||||||0.82||||||significance level = 0.01|t-test, 2 sided|||Social subscale||||0.82
72371045|NCT00329797|144252020|SUPERIORITY|||||||0.51||||||significance level = 0.01|t-test, 2 sided|||Emotional subscale||||0.51
72371046|NCT00329797|144252020|SUPERIORITY|||||||0.25||||||significance level = 0.01|t-test, 2 sided|||Functional subscale||||0.25
72371047|NCT00329797|144252020|SUPERIORITY|||||||0.63||||||significance level = 0.01|t-test, 2 sided|||Total||||0.63
72371048|NCT00800254|144252039|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||||||<0.001
72371049|NCT00800254|144252041|SUPERIORITY_OR_OTHER||||||<|0.003|TWO_SIDED||||||ANCOVA|||||||<0.003
72371050|NCT02758184|144252051|OTHER||Mean Difference (Final Values)|1031.2|STANDARD_ERROR_OF_MEAN|681.7||0.15|TWO_SIDED||||||ANOVA|||||||0.15
72371051|NCT01253577|144252076|SUPERIORITY_OR_OTHER|||||||0.028||95.0|||||McNemar|||||||0.0280
72371052|NCT01253577|144252077|SUPERIORITY_OR_OTHER||||||<|0.0001|ONE_SIDED|95.0|||||Fisher Exact|||||||<0.0001
72371053|NCT01253577|144252078|SUPERIORITY_OR_OTHER|||||||0.0023|TWO_SIDED|95.0|||||McNemar|||||||0.0023
72371054|NCT01303224|144252270|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0||||Multiplicity was adjusted by using the Hochberg Procedure.|Mantel Haenszel|||Mantel-Haenszel-Test was used to compare separately each of the 3 active treatment groups with placebo using a two-sided overall significance level of 5%. The proportion of responders was tested with the following hypotheses: H0 (placebo) vs H1(Ibodutant:1mg/3mg/10mg). Approximately 80% power based on the assumptions: rate placebo 40%, expected mean therapeutic gain over placebo 15% for at least one dose of Ibodutant.||||<0.05
72371055|NCT01303224|144252271|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0||||Multiplicity was adjusted using the Hochberg procedure.|Mantel Haenszel|||||||<0.05
72371056|NCT02834793|144252278|SUPERIORITY||Median Difference (Net)|-19.3|||=|0.107|TWO_SIDED|95.0|-49.2|4.8||The p-value was based on a rank analysis of covariance (ANCOVA) with treatment, region, and age-group as factors, and prerandomization drop seizure frequency as a covariate.|ANCOVA||The median difference to placebo and the 95 percent (%) confidence interval (CI) were based on the Hodges-Lehmann method.|||4.8|-49.2|= 0.107
72371057|NCT00622440|144252299|OTHER||Wilcoxon Rank Sum Effect Size|0.275||||0.042|TWO_SIDED|95.0|||||Wilcoxon rank sum||The wilcoxon rank sum effect size ranges in strength of effect from small (0.10 - \< 0.30), to medium (0.30 - \< 0.50), to large (\>=0.50) with a total range of 0 to 1|Estimated Effect Size for Phase 3 Trial||||.042
72371058|NCT01667419|144252306|SUPERIORITY||Hazard Ratio (HR)|0.54||||0.001|TWO_SIDED|95.0|0.37|0.78|||Log Rank|||||0.78|0.37|0.0010
72469397|NCT01827046|144462476|SUPERIORITY|||||||0.01|||||||Chi-squared|||||||0.01
72469398|NCT01018732|144462514|SUPERIORITY_OR_OTHER||ratio of titer|2.39|||||TWO_SIDED|95.0|1.39|4.1|||ANOVA|||Day 1, Men A, Pairwise comparison of geometric mean titer||4.1|1.39|
72469399|NCT01018732|144462514|SUPERIORITY_OR_OTHER||ratio of titer|0.71|||||TWO_SIDED|95.0|0.42|1.2|||ANOVA|||Day 1, Men A, Pairwise comparison of geometric mean titer||1.2|0.42|
72469400|NCT01018732|144462514|SUPERIORITY_OR_OTHER||ratio of titer|1.68|||||TWO_SIDED|95.0|0.98|2.9|||ANOVA|||Day 1, Men A, Pairwise comparison of geometric mean titer||2.9|0.98|
72469401|NCT01018732|144462514|SUPERIORITY_OR_OTHER||ratio of titer|1.31|||||TWO_SIDED|95.0|0.59|2.91|||ANOVA|||Day 8, Men A, Pairwise comparison of geometric mean titer||2.91|0.59|
72553932|NCT04516967|144640013|SUPERIORITY|||||||0.7175|||||||Fisher Exact|||||||0.7175
72371059|NCT01667419|144252306|SUPERIORITY||Hazard Ratio (HR)|0.8||||0.2598|TWO_SIDED|95.0|0.54|1.18|||Log Rank|||||1.18|0.54|0.2598
72371060|NCT01667419|144252307|SUPERIORITY||Hazard Ratio (HR)|0.58||||0.0133|TWO_SIDED|95.0|0.37|0.9|||Log Rank|||||0.90|0.37|0.0133
72371061|NCT01667419|144252307|SUPERIORITY||Hazard Ratio (HR)|0.91||||0.6815|TWO_SIDED|95.0|0.57|1.44|||Log Rank|||||1.44|0.57|0.6815
72371062|NCT01667419|144252308|SUPERIORITY||Hazard Ratio (HR)|0.53||||0.0274|TWO_SIDED|95.0|0.3|0.94|||Log Rank|||||.94|0.30|0.0274
72371063|NCT01667419|144252308|SUPERIORITY||Hazard Ratio (HR)|0.95||||0.8597|TWO_SIDED|95.0|0.55|1.66|||Log Rank|||||1.66|0.55|0.8597
72371064|NCT06026124|144252338|SUPERIORITY||||||<|1e-05|||||||LSD test|||||||<0.00001
72371065|NCT06026124|144252338|SUPERIORITY||||||<|1e-05|||||||LSD test|||||||<0.00001
72371066|NCT06026124|144252339|SUPERIORITY||||||<|1e-05|||||||LSD test|||||||<0.00001
72371067|NCT06026124|144252339|SUPERIORITY||||||<|1e-05|||||||LSD test|||||||<0.00001
72371068|NCT06026124|144252340|SUPERIORITY||||||<|1e-05|||||||LSD test|||||||<0.00001
72371069|NCT06026124|144252340|SUPERIORITY||||||<|1e-05|||||||LSD test|||||||<0.00001
72371070|NCT06026124|144252341|SUPERIORITY||||||<|0.0001|||||||LSD test|||||||<0.0001
72371071|NCT06026124|144252341|SUPERIORITY||||||<|1e-05|||||||LSD test|||||||<0.00001
72371072|NCT06026124|144252342|SUPERIORITY||||||=|0.17|||||||LSD test|||||||=0.17
72371073|NCT06026124|144252342|SUPERIORITY||||||=|1|||||||LSD test|||||||=1.00
72371074|NCT06026124|144252343|SUPERIORITY||||||<|0.0001|||||||LSD test|||||||<0.0001
72371075|NCT06026124|144252344|SUPERIORITY||||||=|0.51|||||||LSD test|||||||=0.51
72371076|NCT03023813|144252348|OTHER|||||||0.5|||||||t-test, 2 sided|||||||0.50
72371077|NCT03023813|144252349|OTHER|||||||0.25|||||||t-test, 2 sided|||||||.25
72371078|NCT03023813|144252350|OTHER|||||||0.39|||||||t-test, 2 sided|||||||.39
72371079|NCT03023813|144252351|OTHER|||||||0.59|||||||t-test, 2 sided|||||||0.59
72371080|NCT03023813|144252352|OTHER|||||||0.53|||||||t-test, 2 sided|||||||0.53
72371081|NCT03023813|144252353|OTHER|||||||0.91|||||||t-test, 2 sided|||||||0.91
72614830|NCT01312129|144759723|SUPERIORITY_OR_OTHER||||||=|0.05|TWO_SIDED|||||=0.05 is the actual computed p-value via the ANOVA.|ANOVA|The ANOVA is comparing the % increase in BOLD response above baseline during cue presentation (Alcohol vs. Control) b/w placebo \& Sulfasalazine .||||||=.05
72493021|NCT00691483|144514814|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.45|||<|0.0001|TWO_SIDED|95.0|2.62|7.55||To preserve the type I family-wise error rate of 0.05, a step-down procedure to be used for the analysis of CA for Week 9 through Week 12 and the CA for Week 9 through Week 24.|Regression, Logistic|Model to include the main effects of treatment and pooled center.||Sample size to be based on a continuity-corrected Chi-square 2-sided test with a 0.05 significance level and a 3:1 randomization ratio of Varenicline to placebo. 652 subjects to provide \>=90% power to detect Varenicline versus placebo differences in primary and key secondary efficacy endpoints (assuming placebo CA rates of 0.24 \[Weeks 9-12\] and 0.18 \[Weeks 9-24\] and Varenicline CA rates of 0.46 \[Weeks 9-12\] and 0.31 \[Weeks 9-24\]) (odds ratio of \>=2.67 \[Weeks 9-12\] and \>=2.10 \[Weeks 9-24\]).||7.55|2.62|<0.0001
72493022|NCT00691483|144514815|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.91|||<|0.0001|TWO_SIDED|95.0|2.96|8.13||A 0.05 level of significance without adjustment for multiplicity.|Regression, Logistic|Model to include the main effects of treatment and pooled center.||Statistical testing to be 2-sided and use a 0.05 level of significance. Confidence intervals to have a 95% confidence level. Statistical significance to be declared unless a p-value \>0.05 was obtained.||8.13|2.96|<0.0001
72493023|NCT00691483|144514816|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.66|||<|0.0001|TWO_SIDED|95.0|3.66|8.75||A 0.05 level of significance without adjustment for multiplicity.|Regression, Logistic|Model to include the main effects of treatment and pooled center.||Week 12. Statistical testing to be 2-sided and use a 0.05 level of significance. Confidence intervals to have a 95% confidence level. Statistical significance to be declared unless a p-value \>0.05 was obtained.||8.75|3.66|<0.0001
72493024|NCT00691483|144514816|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.12|||<|0.0001|TWO_SIDED|95.0|2.58|6.58||A 0.05 level of significance without adjustment for multiplicity.|Regression, Logistic|Model to include the main effects of treatment and pooled center.||Week 24. Statistical testing to be 2-sided and use a 0.05 level of significance. Confidence intervals to have a 95% confidence level. Statistical significance to be declared unless a p-value \>0.05 was obtained.||6.58|2.58|<0.0001
72493025|NCT00691483|144514817|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.14|||<|0.0001|TWO_SIDED|95.0|2.58|6.67||A 0.05 level of significance without adjustment for multiplicity.|Regression, Logistic|Model to include the main effects of treatment and pooled center.||Statistical testing to be 2-sided and use a 0.05 level of significance. Confidence intervals to have a 95% confidence level. Statistical significance to be declared unless a p-value \>0.05 was obtained.||6.67|2.58|<0.0001
72493026|NCT00439946|144514819|SUPERIORITY_OR_OTHER_LEGACY|||||||0.84||95.0|||||Wilcoxon signed rank|||Changes between Baseline and Week 8 were assessed using the Wilcoxon signed rank test, comparing the values at Baseline to values at Week 8. A two-sided p value of \< 0.05 was considered statistically significant. No imputation was used for missing values.||||0.84
72371082|NCT03023813|144252354|OTHER|Percent change in weight (lbs.) since the baseline encounter|Mean Difference (Net)|-2.96||||0.27|TWO_SIDED|95.0|-8.18|2.26|||Mixed Models Analysis||Result for intervention arm minus control arm|Among participants whose individualized preventive care recommendations included weight loss||2.26|-8.18|0.27
72493027|NCT00439946|144514820|SUPERIORITY_OR_OTHER_LEGACY|||||||1||95.0|||||Wilcoxon signed rank|||Changes between Baseline and Week 8 were assessed using the Wilcoxon signed rank test, comparing the values at Baseline to values at Week 8. A two-sided p value of \< 0.05 was considered statistically significant. No imputation was used for missing values.||||1.00
72614831|NCT00924651|144759727|OTHER||Mean Difference (Final Values)|-0.01916|STANDARD_ERROR_OF_MEAN|0.1791||0.9148|TWO_SIDED|95.0|-0.371|0.3327|||ANCOVA|||||0.3327|-0.3710|0.9148
72371083|NCT03023813|144252354|OTHER|Change in systolic blood pressure since the baseline encounter (mmHg)|Mean Difference (Net)|-6.42||||0.19|TWO_SIDED|95.0|-16.12|3.27|||Mixed Models Analysis||Result for intervention arm minus control arm|Among participants whose individualized preventive care recommendations included blood pressure control||3.27|-16.12|0.19
72493028|NCT00439946|144514821|SUPERIORITY_OR_OTHER_LEGACY|||||||1||95.0|||||Wilcoxon signed rank|||Changes between Baseline and Week 8 were assessed using the Wilcoxon signed rank test, comparing the values at Baseline to values at Week 8. A two-sided p value of \< 0.05 was considered statistically significant. No imputation was used for missing values.||||1.00
72493029|NCT00439946|144514822|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5||95.0|||||Wilcoxon signed rank|||Changes between Baseline and Week 8 were assessed using the Wilcoxon signed rank test, comparing the values at Baseline to values at Week 8. A two-sided p value of \< 0.05 was considered statistically significant. No imputation was used for missing values||||0.50
72493030|NCT00439946|144514823|SUPERIORITY_OR_OTHER_LEGACY|||||||1||95.0|||||Wilcoxon signed rank|||Changes between Baseline and Week 8 were assessed using the Wilcoxon signed rank test, comparing the values at Baseline to values at Week 8. A two-sided p value of \< 0.05 was considered statistically significant. No imputation was used for missing values||||1.00
72371084|NCT03023813|144252354|OTHER|Percentage point change in HbA1c (%) since the baseline encounter|Mean Difference (Net)|-0.68||||0.24|TWO_SIDED|95.0|-1.82|0.45|||Mixed Models Analysis||Result for intervention arm minus control arm|Among participants whose individualized preventive care recommendations included glycemic control||0.45|-1.82|0.24
72469402|NCT01018732|144462514|SUPERIORITY_OR_OTHER||ratio of titer|24.0|||||TWO_SIDED|95.0|11.0|52.0|||ANOVA|||Day 8, Men A, Pairwise comparison of geometric mean titer||52|11|
72469403|NCT01018732|144462514|SUPERIORITY_OR_OTHER||ratio of titer|31.0|||||TWO_SIDED|95.0|14.0|69.0|||ANOVA|||Day 8, Men A, Pairwise comparison of geometric mean titer||69|14|
72493031|NCT00439946|144514824|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5||95.0|||||Wilcoxon signed rank|||Changes between Baseline and Week 8 were assessed using the Wilcoxon signed rank test, comparing the values at Baseline to values at Week 8. A two-sided p value of \< 0.05 was considered statistically significant. No imputation was used for missing values||||0.50
72493032|NCT00439946|144514825|SUPERIORITY_OR_OTHER_LEGACY|||||||1||95.0|||||Wilcoxon signed rank|||Changes between Baseline and Week 8 were assessed using the Wilcoxon signed rank test, comparing the values at Baseline to values at Week 8. A two-sided p value of \< 0.05 was considered statistically significant. No imputation was used for missing values||||1.0
72614832|NCT02034591|144759740|SUPERIORITY_OR_OTHER||Ratio of Adjusted Geometric Means|0.682|||||TWO_SIDED|90.0|0.621|0.748||||||||0.748|0.621|
72614833|NCT02034591|144759741|SUPERIORITY_OR_OTHER||Ratio of Adjusted Geometric Means|0.813|||||TWO_SIDED|90.0|0.766|0.863||||||||0.863|0.766|
72614834|NCT02034591|144759742|SUPERIORITY_OR_OTHER||Ratio of Adjusted Geometric Means|0.81|||||TWO_SIDED|90.0|0.764|0.86||||||||0.860|0.764|
72493033|NCT00439946|144514826|SUPERIORITY_OR_OTHER_LEGACY|||||||0.75||95.0|||||Wilcoxon signed rank|||Changes between Baseline and Week 8 were assessed using the Wilcoxon signed rank test, comparing the values at Baseline to values at Week 8. A two-sided p value of \< 0.05 was considered statistically significant. No imputation was used for missing values||||0.75
72493034|NCT00439946|144514827|SUPERIORITY_OR_OTHER_LEGACY|||||||1||95.0|||||Wilcoxon signed rank|||Changes between Baseline and Week 8 were assessed using the Wilcoxon signed rank test, comparing the values at Baseline to values at Week 8. A two-sided p value of \< 0.05 was considered statistically significant. No imputation was used for missing values||||1.0
72493035|NCT00439946|144514828|SUPERIORITY_OR_OTHER_LEGACY|||||||1||95.0|||||Wilcoxon signed rank|||Changes between Baseline and Week 8 were assessed using the Wilcoxon signed rank test, comparing the values at Baseline to values at Week 8. A two-sided p value of \< 0.05 was considered statistically significant. No imputation was used for missing values||||1.00
72493036|NCT00439946|144514829|SUPERIORITY_OR_OTHER_LEGACY|||||||0.95||95.0||||p-value for: Gather/set-up|Wilcoxon signed rank|||Changes in mean times between Baseline and Week 8 were assessed using the Wilcoxon signed rank test, comparing the values at Baseline to values at Week 8. A two-sided p value of \< 0.05 was considered statistically significant. No imputation was used for missing values.||||0.95
72493037|NCT00439946|144514829|SUPERIORITY_OR_OTHER_LEGACY|||||||0.02||95.0||||p-value for: Prepare drug|Wilcoxon signed rank|||Changes in mean times between Baseline and Week 8 were assessed using the Wilcoxon signed rank test, comparing the values at Baseline to values at Week 8. A two-sided p value of \< 0.05 was considered statistically significant. No imputation was used for missing values.||||0.02
72493038|NCT00439946|144514829|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2||95.0||||p-value for: Connect drug|Wilcoxon signed rank|||Changes in mean times between Baseline and Week 8 were assessed using the Wilcoxon signed rank test, comparing the values at Baseline to values at Week 8. A two-sided p value of \< 0.05 was considered statistically significant. No imputation was used for missing values.||||0.20
72493039|NCT00439946|144514829|SUPERIORITY_OR_OTHER_LEGACY|||||||0.48||95.0||||p-value for: Change dressing|Wilcoxon signed rank|||Changes in mean times between Baseline and Week 8 were assessed using the Wilcoxon signed rank test, comparing the values at Baseline to values at Week 8. A two-sided p value of \< 0.05 was considered statistically significant. No imputation was used for missing values.||||0.48
72493040|NCT00439946|144514829|SUPERIORITY_OR_OTHER_LEGACY|||||||0.11||95.0||||p-value for: Total time|Wilcoxon signed rank|||Changes in mean times between Baseline and Week 8 were assessed using the Wilcoxon signed rank test, comparing the values at Baseline to values at Week 8. A two-sided p value of \< 0.05 was considered statistically significant. No imputation was used for missing values.||||0.11
72493041|NCT00439946|144514830|SUPERIORITY_OR_OTHER_LEGACY|||||||0.31||95.0||||p-value for: CAMPHOR Symptom Score|Wilcoxon signed rank|||Changes in mean TSQM and CAMPHOR scores between Baseline and Week 8 were assessed using the Wilcoxon signed rank test, comparing the values at Baseline to values at Week 8. A two-sided p value of \< 0.05 was considered statistically significant. No imputation was used for missing values.||||0.31
72493042|NCT00439946|144514830|SUPERIORITY_OR_OTHER_LEGACY|||||||0.84||95.0||||p-value for CAMPHOR Activity Score|Wilcoxon signed rank|||Changes in mean TSQM and CAMPHOR scores between Baseline and Week 8 were assessed using the Wilcoxon signed rank test, comparing the values at Baseline to values at Week 8. A two-sided p value of \< 0.05 was considered statistically significant. No imputation was used for missing values.||||0.84
72493043|NCT00439946|144514830|SUPERIORITY_OR_OTHER_LEGACY|||||||0.03||95.0||||p-value for CAMPHOR Quality of Life Score|Wilcoxon signed rank|||Changes in mean TSQM and CAMPHOR scores between Baseline and Week 8 were assessed using the Wilcoxon signed rank test, comparing the values at Baseline to values at Week 8. A two-sided p value of \< 0.05 was considered statistically significant. No imputation was used for missing values.||||0.03
72493044|NCT00439946|144514830|SUPERIORITY_OR_OTHER_LEGACY|||||||0.22||95.0||||p-value for CAMPHOR Total Score|Wilcoxon signed rank|||Changes in mean TSQM and CAMPHOR scores between Baseline and Week 8 were assessed using the Wilcoxon signed rank test, comparing the values at Baseline to values at Week 8. A two-sided p value of \< 0.05 was considered statistically significant. No imputation was used for missing values.||||0.22
72614835|NCT02034591|144759743|SUPERIORITY_OR_OTHER||Ratio of Adjusted Geometric Means|0.884|||||TWO_SIDED|90.0|0.83|0.942||||||||0.942|0.830|
72614836|NCT02034591|144759744|SUPERIORITY_OR_OTHER||Ratio of Adjusted Geometric Means|0.95|||||TWO_SIDED|90.0|0.905|0.997||||||||0.997|0.905|
72493045|NCT00439946|144514831|SUPERIORITY_OR_OTHER_LEGACY|||||||0.55||95.0||||p-value for TSQM Effectiveness Score|Wilcoxon signed rank|||Changes in mean TSQM and CAMPHOR scores between Baseline and Week 8 were assessed using the Wilcoxon signed rank test, comparing the values at Baseline to values at Week 8. A two-sided p value of \< 0.05 was considered statistically significant. No imputation was used for missing values.||||0.55
72493046|NCT00439946|144514831|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5||95.0||||p-value for TSQM Side-Effects Score|Wilcoxon signed rank|||Changes in mean TSQM and CAMPHOR scores between Baseline and Week 8 were assessed using the Wilcoxon signed rank test, comparing the values at Baseline to values at Week 8. A two-sided p value of \< 0.05 was considered statistically significant. No imputation was used for missing values.||||0.50
72493047|NCT00439946|144514831|SUPERIORITY_OR_OTHER_LEGACY|||||||0.01||95.0||||p-value for TSQM Convenience Score|Wilcoxon signed rank|||Changes in mean TSQM and CAMPHOR scores between Baseline and Week 8 were assessed using the Wilcoxon signed rank test, comparing the values at Baseline to values at Week 8. A two-sided p value of \< 0.05 was considered statistically significant. No imputation was used for missing values.||||0.01
72614837|NCT02034591|144759745|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|0.947|||||TWO_SIDED|90.0|0.903|0.994||||||||0.994|0.903|
72614838|NCT01121926|144759753|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence is established when the ratio of geometric Least Squares means (LSmeans) and confidence interval calculated from the exponential of the difference between the Test and Reference product for the ln-transformed parameter Cmax,ss is between 80% and 125%.|Mean ratio|56.53|||||TWO_SIDED|90.0|49.99|63.94|||||Test/reference (%)|||63.94|49.99|
72469404|NCT01018732|144462514|SUPERIORITY_OR_OTHER||ratio of titer|1.3|||||TWO_SIDED|95.0|0.7|2.42|||ANOVA|||Day 29, Men A, Pairwise comparison of geometric mean titer||2.42|0.7|
72469405|NCT01018732|144462514|SUPERIORITY_OR_OTHER||ratio of titer|5.56|||||TWO_SIDED|95.0|3.01|10.0|||ANOVA|||Day 29, Men A, Pairwise comparison of geometric mean titer||10|3.01|
72493048|NCT00439946|144514831|SUPERIORITY_OR_OTHER_LEGACY|||||||0.52||95.0||||p-value for TSQM Global Satisfaction Score|Wilcoxon signed rank|||Changes in mean TSQM and CAMPHOR scores between Baseline and Week 8 were assessed using the Wilcoxon signed rank test, comparing the values at Baseline to values at Week 8. A two-sided p value of \< 0.05 was considered statistically significant. No imputation was used for missing values.||||0.52
72493049|NCT00049673|144514833|SUPERIORITY||Hazard Ratio (HR)|0.77||||0.18|TWO_SIDED|95.0|0.53|1.14|||Log Rank|||||1.14|0.53|0.18
72493050|NCT00049673|144514834|SUPERIORITY||Hazard Ratio (HR)|0.56||||0.0001|TWO_SIDED|95.0|0.43|0.73|||Log Rank|||||0.73|0.43|0.0001
72493051|NCT02475681|144514835|SUPERIORITY||Hazard Ratio (HR)|0.1|||<|0.0001|TWO_SIDED|95.0|0.06|0.17|||Log Rank|Stratified by randomization stratification factors as recorded in IXRS||The primary test to compare PFS between treatment arms was the two-sided log-rank test, stratified by randomization stratification factors. The estimate of the HR (Arm B/Arm A) and the corresponding 95% CI was computed using a Cox proportional hazards model stratified by randomization stratification factors. Randomization stratification factors were based on the data recorded in IXRS.||0.17|0.06|<0.0001
72493052|NCT02475681|144514836|SUPERIORITY||Hazard Ratio (HR)|0.2|||<|0.0001|TWO_SIDED|95.0|0.13|0.3|||Log Rank|Stratified by randomization stratification factors as recorded in IXRS||The test to compare PFS between treatment Arms A and C was the two-sided log-rank test, stratified by randomization stratification factors. The estimate of the HR and the corresponding 95% CI was computed using a Cox proportional hazards model stratified by randomization stratification factors. Randomization stratification factors were based on the data recorded in IXRS.||0.30|0.13|<0.0001
72493053|NCT02475681|144514837|SUPERIORITY||Risk Difference (RD)|15.3|||<|0.0001|TWO_SIDED|95.0|8.3|22.3|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenzel test with adjustment for randomization stratification factors as recorded in IXRS||||22.3|8.3|<0.0001
72493054|NCT02475681|144514837|SUPERIORITY||Risk Difference (RD)|6.9||||0.0763|TWO_SIDED|95.0|-1.0|14.9|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenzel test with adjustment for randomization stratification factors as recorded in IXRS.||||14.9|-1.0|0.0763
72493055|NCT02475681|144514838|SUPERIORITY||Hazard Ratio (HR)|0.14|||<|0.0001|TWO_SIDED|95.0|0.08|0.26|||Log Rank|Stratified by randomization stratification factors as recorded in IXRS||The test to compare TTNT between treatment Arms A versus B and Arms A versus C was the two-sided log-rank test, stratified by randomization stratification factors. The estimate of the HR and the corresponding 95% CI was computed using a Cox proportional hazards model stratified by randomization stratification factors. Randomization stratification factors were based on the data recorded in IXRS.||0.26|0.08|<0.0001
72493056|NCT02475681|144514838|SUPERIORITY||Hazard Ratio (HR)|0.24|||<|0.0001|TWO_SIDED|95.0|0.15|0.4||P-value based on stratified by randomization stratification factors as recorded in IXRS|Log Rank|Stratified by randomization stratification factors as recorded in IXRS||||0.40|0.15|<0.0001
72493057|NCT02475681|144514839|SUPERIORITY||Hazard Ratio (HR)|0.47||||0.0577|TWO_SIDED|95.0|0.21|1.06|||Log Rank|Stratified by randomization stratification factors as recorded in IXRS||The test to compare overall survival between treatment Arms A versus B and Arms A versus C was the two-sided log-rank test, stratified by randomization stratification factors. The estimate of the HR and the corresponding 95% CI was computed using a Cox proportional hazards model stratified by randomization stratification factors. Randomization stratification factors were based on the data recorded in IXRS.||1.06|0.21|0.0577
72614839|NCT01121926|144759754|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence is established when the ratio of geometric Least Squares means (LSmeans) and confidence interval calculated from the exponential of the difference between the Test and Reference product for the ln-transformed parameter AUCss is between 80% and 125%.|Mean ratio|85.72|||||TWO_SIDED|90.0|81.05|90.67|||||Test/reference (%)|||90.67|81.05|
72371085|NCT03023813|144252354|OTHER|Percentage point change in 10-year atherosclerotic cardiovascular disease risk (%), as estimated by the American College of Cardiology Pooled Cohort Equations, since the baseline encounter|Mean Difference (Net)|-1.2||||0.34|TWO_SIDED|95.0|-3.65|1.26|||Generalized linear mixed regression||Result for intervention arm minus control arm|Among participants whose individualized preventive care recommendations included lipids control||1.26|-3.65|0.34
72371086|NCT03023813|144252354|OTHER|Change in low-density lipoprotein (LDL) cholesterol (mg/dL) since the baseline encounter|Mean Difference (Net)|-8.46||||0.36|TWO_SIDED|95.0|-26.63|9.7|||Mixed Models Analysis||Result for intervention arm minus control arm|Among participants whose individualized preventive care recommendations included lipids control||9.70|-26.63|0.36
72431887|NCT00689104|144375983|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.38||||0.002|TWO_SIDED|95.0|-0.71|-0.05||The response variable for the stratified rank ANCOVA was standardized ranks on change from baseline to Final Visit value with baseline standardized ranks and gender as covariates and geographic region as a stratum.|Stratified rank ANCOVA|LS mean difference was derived from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.||Since there were 2 coprimary efficacy endpoints and 3 key secondary efficacy endpoints, the multiplicity among the endpoints was controlled at a type I error rate at the alpha = 0.05 level using a stepwise parallel gatekeeping procedure (5 stages). In addition, since two mirabegron treatment groups were compared with placebo per endpoint, the Hochberg procedure was used to adjust for multiplicity. A stratified rank ANCOVA model was utilized for hypothesis testing.||-0.05|-0.71|0.002
72493058|NCT02475681|144514839|SUPERIORITY||Hazard Ratio (HR)|0.6||||0.1556|TWO_SIDED|95.0|0.28|1.27|||Log Rank|Stratified by randomization stratification factors as recorded in IXRS||||1.27|0.28|0.1556
72493059|NCT01535729|144514841|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.949|STANDARD_ERROR_OF_MEAN|0.167||0.756|TWO_SIDED|95.0|0.684|1.318|||Wald Chi-Squares|||Comparison between 70-74 years and 65-69 years was reported. Parameter estimates, standard errors, Wald Chi-Squares, p-values, hazard ratios and confidence limits were based on a univariate Cox regression with factor age.||1.318|0.684|0.756
72493060|NCT01535729|144514841|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.744|STANDARD_ERROR_OF_MEAN|0.185||0.11|TWO_SIDED|95.0|0.518|1.07|||Wald Chi-Squares|||Comparison between 75-79 years and 65-69 years was reported. Parameter estimates, standard errors, Wald Chi-Squares, p-values, hazard ratios and confidence limits were based on a univariate Cox regression with factor age.||1.070|0.518|0.110
72553933|NCT03570749|144640014|SUPERIORITY||Odds Ratio (OR)|5.75|||<|0.001|TWO_SIDED|95.0|2.75|12.02|||Regression, Logistic|||||12.02|2.75|<0.001
72431888|NCT00689104|144375983|SUPERIORITY_OR_OTHER_LEGACY||LS mean Difference|-0.35||||0.019|TWO_SIDED|95.0|-0.68|-0.03||The response variable for the stratified rank ANCOVA was standardized ranks on change from baseline to Final Visit value with baseline standardized ranks and gender as covariates and geographic region as a stratum.|Stratified rank ANCOVA|LS mean difference was derived from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.||Since the comparison between tolterodine and placebo was a secondary analysis, no adjustment for multiplicity was necessary.||-0.03|-0.68|0.019
72431889|NCT00689104|144375984|SUPERIORITY_OR_OTHER_LEGACY||LS mean Difference|-0.4||||0.004|TWO_SIDED|95.0|-0.66|-0.13||LS mean difference and p-value were derived from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|ANCOVA|||Since there were 2 coprimary efficacy endpoints and 3 key secondary efficacy endpoints, the multiplicity among the endpoints was controlled at a type I error rate at the alpha = 0.05 level using a stepwise parallel gatekeeping procedure (5 stages). In addition, since two mirabegron treatment groups were compared with placebo per endpoint, the Hochberg procedure was used to adjust for multiplicity. An ANCOVA model was used for hypothesis testing.||-0.13|-0.66|0.004
72469406|NCT01018732|144462514|SUPERIORITY_OR_OTHER||ratio of titer|7.22|||||TWO_SIDED|95.0|3.86|13.0|||ANOVA|||Day 29, Men A, Pairwise comparison of geometric mean titer||13|3.86|
72371087|NCT03023813|144252354|OTHER|Change in smoking intensity (defined as a change in smoking status from Current Every Day to either Current Some Days or Quit; or from Current Some Days to Quit) since the baseline encounter.|Odds Ratio (OR)|1.2||||0.92|TWO_SIDED|95.0|0.03|45.56|||Mixed Models Analysis|Generalized linear mixed regression with logit link|Result for intervention arm relative to control arm. OR \<1 indicates reduction in smoking intensity; OR \>1 indicates increase in smoking intensity.|Among participants whose individualized preventive care recommendations included tobacco cessation||45.56|0.03|0.92
72371088|NCT03023813|144252354|OTHER|Receipt of colorectal cancer screening since the baseline encounter|Odds Ratio (OR)|2.52||||0.99|TWO_SIDED|95.0|0.001|1000.0|||Mixed Models Analysis|Generalized linear mixed regression with logit link|Result for intervention arm relative to control arm. Lower limit estimate was \<0.001 and upper limit estimate was \>1000 (ClinicalTrials.gov does not allow \< or \> to be entered into the confidence interval lower limit or upper limit fields).|Among participants whose individualized preventive care recommendations included colorectal cancer screening||1000|0.001|0.99
72371089|NCT00312195|144252361|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.79|STANDARD_ERROR_OF_MEAN|0.2544||0.0217|TWO_SIDED|95.0|1.09|2.95||P value is from a logistic regression analysis with terms for treatment effect, country and pain site (hip, knee, back and other).|Regression, Logistic||Primary variable was defined as: ratio of the probability of having ineffective treatment divided by the probability of having effective treatment.|H0: the odds of ineffective treatment is the same for subjects receiving placebo as for those receiving BTDS versus the alternative H1: the odds of ineffective treatment is different for subjects receiving placebo from those receiving BTDS.||2.95|1.09|.0217
72371090|NCT02511106|144252365|SUPERIORITY||Hazard Ratio (HR)|0.23|||<|0.0001|TWO_SIDED|95.0|0.18|0.3|||Log Rank|Determined using a log rank test stratified by stage, race and mutation type.|A hazard ratio \<1 favours AZD9291.|||0.30|0.18|<0.0001
72371091|NCT02511106|144252366|SUPERIORITY||Hazard Ratio (HR)|0.27|||<|0.0001|TWO_SIDED|95.0|0.21|0.34|||Log Rank|Determined using a log rank test stratified by stage, race and mutation type.|A hazard ratio \<1 favours AZD9291.|||0.34|0.21|<0.0001
72371092|NCT02511106|144252369|SUPERIORITY||Hazard Ratio (HR)|0.4913||||0.0004|TWO_SIDED|95.03|0.3307|0.7299|||Log Rank|Determined using a log rank test stratified by stage, race and mutation type.|A hazard ratio \<1 favours AZD9291.|||0.7299|0.3307|0.0004
72371093|NCT02511106|144252370|SUPERIORITY||Hazard Ratio (HR)|0.4912|||<|0.0001|TWO_SIDED|95.03|0.3439|0.7017|||Log Rank|Determined using a log rank test stratified by stage, race and mutation type.|A hazard ratio \<1 favours AZD9291.|||0.7017|0.3439|<0.0001
72371094|NCT00104520|144252454|SUPERIORITY_OR_OTHER|||||||0.007||0.0||||Analysis based on 2-sided test with 0.05 a priori threshold for statistical significance. No adjustments were made for multiple comparisons.|Log Rank|||H0: no difference between AZLI and placebo (pooled treatment groups) in time to need for inhaled or IV antibiotics. Assuming 2-sided significance level of 0.05, \~210 subjects (70 in each AZLI group, 35 in each placebo group) provided \>90% power to reject null hypothesis based on Lakatos normal approximation method with weights being one. Therefore, 250 subjects were to be randomized at Visit 2 (Day -28) to ensure at least 210 participants entered double-blind treatment period at Day 0.||||0.0070
72371095|NCT00104520|144252455|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.01||||0.0196|TWO_SIDED|95.0|0.81|9.21||No adjustments were made for multiple comparisons.|ANCOVA|ANCOVA model included terms for treatment and baseline value.||Null hypothesis was there is no difference between 75 mg AZLI and placebo (pooled treatment groups) in change from baseline in CFQ-R RSS scores.||9.21|0.81|0.0196
72614840|NCT01149785|144759819|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|316.36|||||TWO_SIDED|90.0|286.17|349.73||||||Natural log transformed AUC (0-∞) of crizotinib was analyzed using a mixed effect model with treatment as fixed effect and subject as a random effect. The adjusted mean differences and 90% confidence intervals (CIs) for the differences was exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||349.73|286.17|
72371096|NCT00104520|144252456|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.28||||0.0012|TWO_SIDED|95.0|2.5|10.06||No adjustments were made for multiple comparisons.|ANCOVA|ANCOVA model included terms for treatment and baseline value.||Null hypothesis was there is no difference between 75 mg AZLI and placebo (pooled treatment groups) in percent change from baseline in FEV1 (L).||10.060|2.500|0.0012
72371097|NCT00104520|144252458|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.659||||0.0059|TWO_SIDED|95.0|-1.125|-0.193|||ANCOVA|ANCOVA model included terms for treatment and baseline highest MIC of aztreonam for PA (\<=2, 4-8, 16-128 or \>=256 μg/mL) value.||Null hypothesis was there is no difference between 75 mg AZLI and placebo (pooled treatment groups) in mean change from baseline in log10 PA CFUs in sputum.||-0.193|-1.125|0.0059
72469407|NCT01018732|144462514|SUPERIORITY_OR_OTHER||ratio of titer|2.64|||||TWO_SIDED|95.0|1.4|4.99|||ANOVA|||Day 1, Men C, Pairwise comparison of geometric mean titer||4.99|1.4|
72469408|NCT01018732|144462514|SUPERIORITY_OR_OTHER||ratio of titer|1.05|||||TWO_SIDED|95.0|0.56|1.97|||ANOVA|||Day 1, Men C, Pairwise comparison of geometric mean titer||1.97|0.56|
72431890|NCT00689104|144375984|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.52|||<|0.001|TWO_SIDED|95.0|-0.79|-0.26||LS mean difference and p-value were derived from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|ANCOVA|||Since there were 2 coprimary efficacy endpoints and 3 key secondary efficacy endpoints, the multiplicity among the endpoints was controlled at a type I error rate at the alpha = 0.05 level using a stepwise parallel gatekeeping procedure (5 stages). In addition, since two mirabegron treatment groups were compared with placebo per endpoint, the Hochberg procedure was used to adjust for multiplicity. An ANCOVA model was used for hypothesis testing.||-0.26|-0.79|<0.001
72431891|NCT00689104|144375984|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.33||||0.016|TWO_SIDED|95.0|-0.6|-0.06||LS mean difference and p-value were derived from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|ANCOVA|||Since the comparison between tolterodine and placebo was a secondary analysis, no adjustment for multiplicity was necessary.||-0.06|-0.60|0.016
72614841|NCT01149785|144759820|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|328.31|||||TWO_SIDED|90.0|296.42|363.63||||||Natural log transformed AUClast of crizotinib was analyzed using a mixed effect model with treatment as fixed effect and subject as a random effect. The adjusted mean differences and 90% CIs for the differences was exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||363.63|296.42|
72371098|NCT05188053|144252467|OTHER|"Sample size calculations were performed to estimate the number of subjects needed to detect a 30% difference in NRS pain AUC scores between the study groups.~30% reduction in pain was considered the minimal clinically important difference in pain control based off previous pain research.~A 30% reduction in pain would correspond with a difference of approximately 136 in area under the curve of mean pain over time."||||||0.17||||||a priori threshold p \<0.05|t-test, 2 sided|assuming unequal variance||Two-sample t-test with unequal variance. The null hypothesis is that there was no statistically significant difference between the two treatment groups based on a standard alpha value of 0.05.||||0.170
72371099|NCT02447302|144252473|SUPERIORITY||Difference in least square mean|-0.99|STANDARD_ERROR_OF_MEAN|0.42|=|0.0091|TWO_SIDED|90.0|-1.68|-0.3||The analysis was performed using an analysis of covariance (ANCOVA) model that incorporated treatment, current oral corticosteroid use, prior exposure to tumor necrosis factor alpha (TNFα) antagonists, and baseline value as covariate.|ANCOVA|The analysis compared the adapted MCS change from baseline between treatment groups using a 1-sided test at the 0.05 level of significance.|Estimated least square mean difference in etrasimod 2 mg from placebo|The primary comparison in the study was between etrasimod 2 mg versus placebo.||-0.30|-1.68|= 0.0091
72371100|NCT02447302|144252473|SUPERIORITY||Difference in least square mean|-0.43|STANDARD_ERROR_OF_MEAN|0.41|=|0.1457|TWO_SIDED|90.0|-1.11|0.24||The analysis was performed using an ANCOVA model that incorporated treatment, current oral corticosteroid use, prior exposure to TNFα antagonists, and baseline value as covariate.|ANCOVA|The analysis compared the adapted MCS change from baseline between treatment groups using a 1-sided test at the 0.05 level of significance.|Estimated least square mean difference in etrasimod 1 mg from placebo|||0.24|-1.11|= 0.1457
72371101|NCT02447302|144252474|SUPERIORITY||MH estimate for difference in percentage|24.4|STANDARD_ERROR_OF_MEAN|8.87|=|0.003|TWO_SIDED|90.0|9.8|39.0||Mantel-Haenszel (MH) estimated common risk difference adjusted for current oral corticosteroid therapy at baseline and previous exposure to TNFα antagonists.|Mantel Haenszel|The analysis compared the difference in proportions between treatment groups using a 1-sided test at the 0.05 level of significance.|MH estimated difference in etrasimod 2 mg from Placebo|The primary comparison in the study was between etrasimod 2 mg versus placebo.||39.0|9.8|= 0.003
72371102|NCT02447302|144252474|SUPERIORITY||MH estimate for difference in percentage|4.1|STANDARD_ERROR_OF_MEAN|7.98|=|0.3059|TWO_SIDED|90.0|-9.1|17.2||MH estimated common risk difference adjusted for current oral corticosteroid therapy at baseline and previous exposure to TNFα antagonists.|Mantel Haenszel|The analysis compared the difference in proportions between treatment groups using a 1-sided test at the 0.05 level of significance.|MH estimated difference in etrasimod 1 mg from Placebo|||17.2|-9.1|= 0.3059
72371103|NCT02447302|144252475|SUPERIORITY||Difference in least square mean|-0.84|STANDARD_ERROR_OF_MEAN|0.29|=|0.002|TWO_SIDED|90.0|-1.32|-0.36||The analysis was performed using an ANCOVA model that incorporated treatment, current oral corticosteroid use, prior exposure to TNFα antagonists, and baseline value as covariate.|ANCOVA|The analysis compared the 2-component MCS change from baseline between treatment groups using a 1-sided test at the 0.05 level of significance.|Estimated least square mean difference in etrasimod 2 mg from placebo|The primary comparison in the study was between etrasimod 2 mg versus placebo.||-0.36|-1.32|= 0.0020
72371104|NCT02447302|144252475|SUPERIORITY||Difference in least square mean|-0.39|STANDARD_ERROR_OF_MEAN|0.28|=|0.0858|TWO_SIDED|90.0|-0.85|0.08||The analysis was performed using an ANCOVA model that incorporated treatment, current oral corticosteroid use, prior exposure to TNFα antagonists, and baseline value as covariate.|ANCOVA|The analysis compared the 2-component MCS change from baseline between treatment groups using a 1-sided test at the 0.05 level of significance.|Estimated least square mean difference in etrasimod 1 mg from placebo|||0.08|-0.85|= 0.0858
72371105|NCT02447302|144252476|SUPERIORITY||Difference in least square mean|-1.27|STANDARD_ERROR_OF_MEAN|0.55|=|0.01|TWO_SIDED|90.0|-2.17|-0.37||The analysis was performed using an ANCOVA model that incorporated treatment, current oral corticosteroid use, prior exposure to TNFα antagonists, and baseline value as covariate.|ANCOVA|The analysis compared the TMS change from baseline between treatment groups using a 1-sided test at the 0.05 level of significance.|Estimated least square mean difference in etrasimod 2 mg from placebo|The primary comparison in the study was between etrasimod 2 mg versus placebo.||-0.37|-2.17|= 0.0100
72371106|NCT02447302|144252476|SUPERIORITY||Difference in least square mean|-0.6|STANDARD_ERROR_OF_MEAN|0.53|=|0.1277|TWO_SIDED|90.0|-1.48|0.27||The analysis was performed using an ANCOVA model that incorporated treatment, current oral corticosteroid use, prior exposure to TNFα antagonists, and baseline value as covariate.|ANCOVA|The analysis compared the TMS change from baseline between treatment groups using a 1-sided test at the 0.05 level of significance.|Estimated least square mean difference in etrasimod 1 mg from placebo|||0.27|-1.48|= 0.1277
72431892|NCT04873817|144376011|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||||||< 0.0001
72431893|NCT00665561|144376015|SUPERIORITY||Risk Ratio (RR)|0.53|||||TWO_SIDED|95.0|0.42|0.67||||||Poisson regressions were fit to the categorical events with only treatment in the model to obtain the crude risk ratio (RR) and CI.||0.67|0.42|
72431894|NCT00665561|144376016|SUPERIORITY||Risk Ratio (RR)|0.83|||||TWO_SIDED|95.0|0.12|5.88||||||Poisson regressions were fit to the categorical events with only treatment in the model to obtain the crude RR and CI.||5.88|0.12|
72431895|NCT00665561|144376017|SUPERIORITY||Risk Ratio (RR)|0.94|||||TWO_SIDED|95.0|0.66|1.33||||||All Malignancies: Poisson regressions were fit to the categorical events with only treatment in the model to obtain the crude RR and CI.||1.33|0.66|
72431896|NCT00665561|144376017|SUPERIORITY||Risk Ratio (RR)|0.62|||||TWO_SIDED|95.0|0.29|1.31||||||AIDS defining Malignancies: Poisson regressions were fit to the categorical events with only treatment in the model to obtain the crude RR and CI.||1.31|0.29|
72431897|NCT00665561|144376017|SUPERIORITY||Risk Ratio (RR)|1.06|||||TWO_SIDED|95.0|0.71|1.58||||||Non-AIDS defining Malignancies: Poisson regressions were fit to the categorical events with only treatment in the model to obtain the crude RR and CI.||1.58|0.71|
72431898|NCT00665561|144376018|SUPERIORITY||Risk Ratio (RR)|0.98|||||TWO_SIDED|95.0|0.44|2.18||||||Poisson regressions were fit to the categorical events with only treatment in the model to obtain the crude RR and CI.||2.18|0.44|
72431899|NCT00665561|144376019|SUPERIORITY||Risk Ratio (RR)|0.9|||||TWO_SIDED|95.0|0.51|1.59||||||Poisson regressions were fit to the categorical events with only treatment in the model to obtain the crude RR and CI.||1.59|0.51|
72431900|NCT00665561|144376020|SUPERIORITY||Risk Ratio (RR)|1.11|||||TWO_SIDED|95.0|0.7|1.76||||||Poisson regressions were fit to the categorical events with only treatment in the model to obtain the crude RR and CI.||1.76|0.70|
72431901|NCT00665561|144376021|SUPERIORITY||Risk Ratio (RR)|1.1|||||TWO_SIDED|95.0|0.25|4.93||||||Poisson regressions were fit to the categorical events with only treatment in the model to obtain the crude RR and CI.||4.93|0.25|
72431902|NCT00665561|144376022|SUPERIORITY||Risk Ratio (RR)|0.66|||||TWO_SIDED|95.0|0.18|2.47||||||Poisson regressions were fit to the categorical events with only treatment in the model to obtain the crude RR and CI.||2.47|0.18|
72614842|NCT01149785|144759823|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|144.13|||||TWO_SIDED|90.0|126.42|164.33||||||Natural log transformed Cmax of crizotinib was analyzed using a mixed effect model with treatment as fixed effect and subject as a random effect. The adjusted mean differences and 90% CIs for the differences was exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||164.33|126.42|
72614843|NCT01149785|144759826|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|519.65|||||TWO_SIDED|90.0|460.42|586.5||||||Natural log transformed AUClast of crizotinib metabolite (PF-06260182) was analyzed using a mixed effect model with treatment as fixed effect and subject as a random effect. The adjusted mean differences and 90% CIs for the differences was exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||586.50|460.42|
72614844|NCT01149785|144759827|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|516.98|||||TWO_SIDED|90.0|457.88|583.72||||||Natural log transformed AUC (0-∞) of crizotinib metabolite (PF-06260182) was analyzed using a mixed effect model with treatment as fixed effect and subject as a random effect. The adjusted mean differences and 90% CIs for the differences was exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||583.72|457.88|
72371107|NCT02447302|144252477|SUPERIORITY||Odds Ratio (OR)|2.78|||=|0.0071|TWO_SIDED|90.0|1.4|5.51||The analysis was performed using an ordered logistic regression model with terms for treatment, current oral corticosteroid use, and prior exposure to TNFα antagonists.|ANCOVA|The analysis compared the odds of achieving higher trichotomous composite score between the groups using 1-sided test at 0.05 level of significance.||The primary comparison in the study was between etrasimod 2 mg versus placebo.||5.51|1.40|= 0.0071
72431903|NCT00665561|144376023|SUPERIORITY||Risk Ratio (RR)|0.79|||||TWO_SIDED|95.0|0.57|1.08||||||Poisson regressions were fit to the categorical events with only treatment in the model to obtain the crude RR and CI.||1.08|0.57|
72431904|NCT00665561|144376024|SUPERIORITY||Risk Ratio (RR)|0.78|||||TWO_SIDED|95.0|0.61|0.99||||||Poisson regressions were fit to the categorical events with treatment as the main effect, PS quartile and imputed FS as covariates in the model to obtain the adjusted RR and CI.||0.99|0.61|
72431905|NCT00665561|144376025|SUPERIORITY||Risk Ratio (RR)|0.92|||||TWO_SIDED|95.0|0.64|1.33||||||All malignancies: Poisson regressions were fit to the categorical events with treatment as the main effect, PS quartile and imputed FS as covariates in the model to obtain the adjusted RR and CI.||1.33|0.64|
72431906|NCT00665561|144376025|SUPERIORITY||Risk Ratio (RR)|0.7|||||TWO_SIDED|95.0|0.32|1.52||||||AIDS defining malignancies: Poisson regressions were fit to the categorical events with treatment as the main effect, PS quartile and imputed FS as covariates in the model to obtain the adjusted RR and CI.||1.52|0.32|
72431907|NCT00665561|144376025|SUPERIORITY||Risk Ratio (RR)|1.0|||||TWO_SIDED|95.0|0.66|1.52||||||Non-AIDS defining malignancies: Poisson regressions were fit to the categorical events with treatment as the main effect, PS quartile and imputed FS as covariates in the model to obtain the adjusted RR and CI.||1.52|0.66|
72431908|NCT00665561|144376026|SUPERIORITY||Risk Ratio (RR)|0.62|||||TWO_SIDED|95.0|0.35|1.1||||||Poisson regressions were fit to the categorical events with treatment as the main effect, PS quartile and imputed FS as covariates in the model to obtain the adjusted RR and CI.||1.10|0.35|
72493061|NCT01535729|144514841|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.054|STANDARD_ERROR_OF_MEAN|0.242||0.829|TWO_SIDED|95.0|0.656|1.692|||Wald Chi-Squares|||Comparison between ≥ 80 years and 65-69 years was reported. Parameter estimates, standard errors, Wald Chi-Squares, p-values, hazard ratios and confidence limits were based on a univariate Cox regression with factor age.||1.692|0.656|0.829
72431909|NCT00665561|144376027|SUPERIORITY||Risk Ratio (RR)|0.94|||||TWO_SIDED|95.0|0.59|1.52||||||Poisson regressions were fit to the categorical events with treatment as the main effect, PS quartile and imputed FS as covariates in the model to obtain the adjusted RR and CI.||1.52|0.59|
72431910|NCT00665561|144376028|SUPERIORITY||Risk Ratio (RR)|0.92|||||TWO_SIDED|95.0|0.66|1.28||||||Poisson regressions were fit to the categorical events with treatment as the main effect, PS quartile and imputed FS as covariates in the model to obtain the adjusted RR and CI.||1.28|0.66|
72431911|NCT00665561|144376029|SUPERIORITY||Hazard Ratio (HR)|0.92||||0.6225|TWO_SIDED|95.0|0.66|1.28|||Regression, Cox|||||1.28|0.66|0.6225
72469409|NCT01018732|144462514|SUPERIORITY_OR_OTHER||ratio of titer|2.78|||||TWO_SIDED|95.0|1.47|5.27|||ANOVA|||Day 1, Men C, Pairwise comparison of geometric mean titer||5.27|1.47|
72431912|NCT01394991|144376030|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.018||||0.248|TWO_SIDED|95.0|-0.051|0.016|||Chi-squared|||The primary hypothesis was that the group of participants receiving epoetin alfa QW and the group of participants receiving epoetin alfa TIW would have similar incidence rate of participants with at least 1 clinically relevant and objectively confirmed TVE from randomization through Week 16.||0.016|-0.051|0.248
72431913|NCT01394991|144376030|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.53||||0.254||95.0|0.18|1.58|||Regression, Logistic|||||1.58|0.18|0.254
72431914|NCT01394991|144376031|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.029||||0.08|TWO_SIDED|95.0|-0.065|0.007|||Chi-squared|||||0.007|-0.065|0.08
72431915|NCT01394991|144376032|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.4||||0.073|TWO_SIDED|95.0|0.14|1.13|||Log Rank|The stratified log-rank test accounting for ECOG performance status (0 or 1 versus 2) was used to compare the difference between treatment groups.|The Cox regression model with covariates for treatment group and Eastern Cooperative Oncology Group (ECOG) performance status (0 or 1 versus 2) was used for estimates of hazard ratio and its 95% confidence interval.|||1.13|0.14|0.073
72493062|NCT01535729|144514856|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.981|STANDARD_ERROR_OF_MEAN|0.143||0.895|TWO_SIDED|95.0|0.741|1.299|||Wald Chi-Squares|||Comparison between 70-74 years and 65-69 years was reported. Parameter estimates, standard errors, Wald Chi-Squares, p-values, hazard ratios and confidence limits were based on a univariate Cox regression with factor age.||1.299|0.741|0.895
72493063|NCT01535729|144514856|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.689|STANDARD_ERROR_OF_MEAN|0.162||0.022|TWO_SIDED|95.0|0.501|0.947|||Wald Chi-Squares|||Comparison between 75-79 years and 65-69 years was reported. Parameter estimates, standard errors, Wald Chi-Squares, p-values, hazard ratios and confidence limits were based on a univariate Cox regression with factor age.||0.947|0.501|0.022
72493064|NCT01535729|144514856|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.162|STANDARD_ERROR_OF_MEAN|0.212||0.479|TWO_SIDED|95.0|0.767|1.759|||Wald Chi-Squares|||Comparison between ≥ 80 years and 65-69 years was reported. Parameter estimates, standard errors, Wald Chi-Squares, p-values, hazard ratios and confidence limits were based on a univariate Cox regression with factor age.||1.759|0.767|0.479
72614845|NCT01149785|144759829|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|161.42|||||TWO_SIDED|90.0|143.09|182.09||||||Natural log transformed Cmax of crizotinib was analyzed using a mixed effect model with treatment as fixed effect and subject as a random effect. The adjusted mean differences and 90% CIs for the differences was exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||182.09|143.09|
72493065|NCT01535729|144514857|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.732|STANDARD_ERROR_OF_MEAN|0.129||0.015|TWO_SIDED|95.0|0.569|0.941|||Wald Chi-Squares|||Comparison between female and male was reported. Parameter estimates, standard errors, Wald Chi-Squares, p-values, hazard ratios and confidence limits were based on a univariate Cox regression with factor gender.||0.941|0.569|0.015
72493066|NCT01535729|144514858|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.902|STANDARD_ERROR_OF_MEAN|0.156||0|TWO_SIDED|95.0|1.402|2.582|||Wald Chi-Squares|||Comparison between ex-smoker and non-smoker was reported. Parameter estimates, standard errors, Wald Chi-Squares, p-values, hazard ratios and confidence limits were based on a univariate Cox regression with factor smoking.||2.582|1.402|0.000
72493067|NCT01535729|144514858|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.786|STANDARD_ERROR_OF_MEAN|0.183||0.002|TWO_SIDED|95.0|1.248|2.557|||Wald Chi-Squares|||Comparison between smoker and non-smoker was reported. Parameter estimates, standard errors, Wald Chi-Squares, p-values, hazard ratios and confidence limits were based on a univariate Cox regression with factor smoking.||2.557|1.248|0.002
72493068|NCT01535729|144514861|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.717|STANDARD_ERROR_OF_MEAN|0.15||0.027|TWO_SIDED|95.0|0.535|0.962|||Wald Chi-Squares|||Comparison between female and male was reported. Parameter estimates, standard errors, Wald Chi-Squares, p-values, hazard ratios and confidence limits were based on a univariate Cox regression with factor gender.||0.962|0.535|0.027
72431916|NCT01394991|144376033|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.039||||0.059||95.0|-0.083|0.005|||Chi-squared|||||0.005|-0.083|0.059
72493069|NCT01535729|144514862|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.935|STANDARD_ERROR_OF_MEAN|0.179||0|TWO_SIDED|95.0|1.362|2.749|||Wald Chi-Squares|||Comparison between ex-smoker and non-smoker was reported. Parameter estimates, standard errors, Wald Chi-Squares, p-values, hazard ratios and confidence limits were based on a univariate Cox regression with factor smoking.||2.749|1.362|0.000
72431917|NCT01394991|144376034|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.47||||0.054|TWO_SIDED|95.0|0.21|1.03|||Log Rank|The stratified log-rank test accounting for ECOG score status (0 or 1 versus 2) was used to compare the difference between treatment groups.|The Cox regression model including covariates for treatment group and the Eastern Cooperative Oncology Group (ECOG) score status (0 or 1 versus 2) was used for estimates of a hazard ratio and its 95% confidence interval.|||1.03|0.21|0.054
72431918|NCT01394991|144376035|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.0041||||0.88||95.0|-0.0526|0.0608|||Chi-squared|||||0.0608|-0.0526|0.88
72431919|NCT01394991|144376036|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.026||||0.514|TWO_SIDED|95.0|-0.056|0.108|||Chi-squared|||||0.108|-0.056|0.514
72431920|NCT01394991|144376037|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.003||||0.92|TWO_SIDED|95.0|-0.071|0.065|||Chi-squared|||||0.065|-0.071|0.920
72431921|NCT02081365|144376038|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.2|||<|0.05|TWO_SIDED|95.0|0.74|3.55|||ANCOVA|||Comparison of two groups at 1 month follow up with baseline value as the covariate||3.55|.74|<0.05
72431922|NCT02081365|144376039|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.98|||<|0.05|TWO_SIDED|95.0|0.39|1.57|||ANCOVA|||Comparison of two groups at 1 month follow up with baseline value as the covariate||1.57|.39|<0.05
72431923|NCT02081365|144376040|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.23|||<|0.05|TWO_SIDED|95.0|0.61|1.85|||ANCOVA|||Comparison of two groups at 1 month follow up with baseline value as the covariate||1.85|.61|<0.05
72431924|NCT02081365|144376041|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.82|||<|0.05|TWO_SIDED|95.0|0.01|1.64|||ANCOVA|||Comparison of two groups at 1 month follow up with baseline value as the covariate||1.64|.01|<0.05
72431925|NCT01324882|144376060|OTHER|||||||1|||||||Fisher Exact|||||||1.00
72553934|NCT03570749|144640014|SUPERIORITY||Odds Ratio (OR)|11.8|||<|0.001|TWO_SIDED|95.0|5.89|23.62|||Regression, Logistic|||||23.62|5.89|<0.001
72493070|NCT01535729|144514862|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.882|STANDARD_ERROR_OF_MEAN|0.213||0.003|TWO_SIDED|95.0|1.239|2.859|||Wald Chi-Squares|||Comparison between smoker and non-smoker was reported. Parameter estimates, standard errors, Wald Chi-Squares, p-values, hazard ratios and confidence limits were based on a univariate Cox regression with factor smoking.||2.859|1.239|0.003
72493071|NCT01262365|144514864|SUPERIORITY||Odds Ratio (OR)|1.307|||=|0.175|TWO_SIDED|95.0|0.888|1.923|||Regression, Logistic|p-values have been calculated using logistic regression with factors for treatment, region, and baseline disease status.||Odds Ratio: Epratuzumab/Placebo calculated using logistic regression with factors for treatment, region, and baseline disease status.||1.923|0.888|=0.175
72493072|NCT01262365|144514864|SUPERIORITY||Odds Ratio (OR)|1.164|||=|0.442|TWO_SIDED|95.0|0.79|1.714|||Regression, Logistic|p-values have been calculated using logistic regression with factors for treatment, region, and baseline disease status.||Odds Ratio: Epratuzumab/Placebo calculated using logistic regression with factors for treatment, region, and baseline disease status.||1.714|0.790|=0.442
72493073|NCT00326898|144514870|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.02||||0.8|TWO_SIDED|97.5|0.85|1.23|||Stratified logrank test|Stratified logrank test was performed. Stratification factors include basis of risk group, histologic subtype, performance status and type of surgery.||||1.23|0.85|0.80
72493074|NCT00326898|144514870|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.97||||0.72|TWO_SIDED|97.5|0.8|1.17|||Stratified logrank test|Stratified logrank test was performed. Stratification factors include basis of risk group, histologic subtype, performance status and type of surgery.||||1.17|0.80|0.72
72493075|NCT00326898|144514871|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.17|||||TWO_SIDED|97.5|0.9|1.52|||||Hazard ratio was estimated using stratified proportional hazards model with Arm C (placebo arm) as the reference group.|||1.52|0.90|
72371108|NCT02447302|144252477|SUPERIORITY||Odds Ratio (OR)|1.61|||=|0.1192|TWO_SIDED|90.0|0.83|3.14||The analysis was performed using an ordered logistic regression model with terms for treatment, current oral corticosteroid use, and prior exposure to TNFα antagonists.|ANCOVA|The analysis compared the odds of achieving higher trichotomous composite score between the groups using 1-sided test at 0.05 level of significance.||||3.14|0.83|= 0.1192
72371109|NCT02447302|144252478|SUPERIORITY||MH estimate for difference in percentage|25.8|STANDARD_ERROR_OF_MEAN|7.47|=|0.0003|TWO_SIDED|90.0|13.5|38.1||The analysis was performed using MH method that was adjusted for current oral corticosteroid therapy at baseline and previous exposure to TNFα antagonists.|Mantel Haenszel|The analysis compared the difference in proportions between treatment groups using a 1-sided test at the 0.05 level of significance.|MH estimated difference in etrasimod 2 mg from Placebo|The primary comparison in the study was between etrasimod 2 mg versus placebo.||38.1|13.5|= 0.0003
72493076|NCT00326898|144514871|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.98|||||TWO_SIDED|97.5|0.75|1.28|||||Hazard ratio was estimated using stratified proportional hazards model with Arm C (placebo arm) as the reference group.|||1.28|0.75|
72371110|NCT02447302|144252478|SUPERIORITY||MH estimate for difference in percentage|7.1|STANDARD_ERROR_OF_MEAN|6.46|=|0.136|TWO_SIDED|90.0|-3.5|17.7||The analysis was performed using MH method that was adjusted for current oral corticosteroid therapy at baseline and previous exposure to TNFα antagonists.|Mantel Haenszel|The analysis compared the difference in proportions between treatment groups using a 1-sided test at the 0.05 level of significance.|MH estimated difference in etrasimod 1 mg from Placebo|||17.7|-3.5|= 0.1360
72431926|NCT03230006|144376074|SUPERIORITY||Partial eta squared|0.152||||0.002|TWO_SIDED|95.0|||||ANOVA||A two-way mixed ANOVA was conducted to investigate treatment group differences in change in mean number of drinks consumed from baseline to post-treatment, as indicated by the Time by Treatment Condition interaction effect.|||||0.002
72493077|NCT01166230|144514911|SUPERIORITY_OR_OTHER|||||||0.141|||||||Fisher Exact|||||||0.141
72493078|NCT01166230|144514912|SUPERIORITY_OR_OTHER|||||||0.041|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.041
72493079|NCT01166230|144514913|SUPERIORITY_OR_OTHER|||||||0.056|TWO_SIDED|99.0|||||Wilcoxon (Mann-Whitney)|||||||0.056
72493080|NCT04986202|144514972|SUPERIORITY||Mean Difference (Final Values)|-0.92||||0.537|TWO_SIDED|95.0|-3.86|2.02||Two-sided test.|ANCOVA|Treatment group, neutrophil count stratification factor and the baseline value are included in the model as explanatory variables.|Difference in adjusted mean change from baseline between AZD4831 and placebo.|||2.02|-3.86|0.537
72493081|NCT04986202|144514972|SUPERIORITY||Mean Difference (Final Values)|-1.81||||0.221|TWO_SIDED|95.0|-4.71|1.09||Two-sided test.|ANCOVA|Treatment group, neutrophil count stratification factor and the baseline value are included in the model as explanatory variables.|Difference in adjusted mean change from baseline between AZD4831 and placebo.|||1.09|-4.71|0.221
72493082|NCT04986202|144514973|SUPERIORITY||Mean Difference (Final Values)|2.4||||0.559|TWO_SIDED|95.0|-5.7|10.5||Two-sided test.|ANCOVA|Treatment group, neutrophil count stratification factor and the baseline value are included in the model as explanatory variables.|Difference in adjusted mean change from baseline between AZD4831 and placebo.|||10.5|-5.7|0.559
72493083|NCT04986202|144514973|SUPERIORITY||Mean Difference (Final Values)|5.3||||0.195|TWO_SIDED|95.0|-2.7|13.3||Two-sided test.|ANCOVA|Treatment group, neutrophil count stratification factor and the baseline value are included in the model as explanatory variables.|Difference in adjusted mean change from baseline between AZD4831 and placebo.|||13.3|-2.7|0.195
72493084|NCT04986202|144514974|SUPERIORITY||Mean Difference (Final Values)|-1.65||||0.289|TWO_SIDED|95.0|-4.71|1.41||Two-sided test.|ANCOVA|Treatment group, neutrophil count stratification factor and the baseline value are included in the model as explanatory variables.|Difference in adjusted mean change from baseline between AZD4831 and placebo.|Change from baseline at 24 weeks||1.41|-4.71|0.289
72493085|NCT04986202|144514974|SUPERIORITY||Mean Difference (Final Values)|-0.87||||0.571|TWO_SIDED|95.0|-3.86|2.13||Two-sided test.|ANCOVA|Treatment group, neutrophil count stratification factor and the baseline value are included in the model as explanatory variables.|Difference in adjusted mean change from baseline between AZD4831 and placebo.|Change from baseline at 24 weeks||2.13|-3.86|0.571
72493086|NCT04986202|144514974|SUPERIORITY||Mean Difference (Final Values)|-0.25||||0.89|TWO_SIDED|95.0|-3.8|3.3||Two-sided test.|ANCOVA|Treatment group, neutrophil count stratification factor and the baseline value are included in the model as explanatory variables.|Difference in adjusted mean change from baseline between AZD4831 and placebo.|Change from baseline at 48 weeks||3.30|-3.80|0.890
72553935|NCT03570749|144640015|SUPERIORITY||Odds Ratio (OR)|3.92|||<|0.001|TWO_SIDED|95.0|1.81|8.51|||Regression, Logistic|||||8.51|1.81|<0.001
72371111|NCT02447302|144252479|SUPERIORITY||MH estimate for difference in percentage|18.9|STANDARD_ERROR_OF_MEAN|9.92|=|0.0282|TWO_SIDED|90.0|2.6|35.3||The analysis was performed using MH method that was adjusted for current oral corticosteroid therapy at baseline and previous exposure to TNFα antagonists.|Mantel Haenszel|The analysis compared the difference in proportions between treatment groups using a 1-sided test at the 0.05 level of significance.|MH estimated difference in etrasimod 2 mg from Placebo|The primary comparison in the study was between etrasimod 2 mg versus placebo.||35.3|2.6|= 0.0282
72371112|NCT02447302|144252479|SUPERIORITY||MH estimate for difference in percentage|11.4|STANDARD_ERROR_OF_MEAN|10.14|=|0.1309|TWO_SIDED|90.0|-5.3|28.1||The analysis was performed using MH method that was adjusted for current oral corticosteroid therapy at baseline and previous exposure to TNFα antagonists.|Mantel Haenszel|The analysis compared the difference in proportions between treatment groups using a 1-sided test at the 0.05 level of significance.|MH estimated difference in etrasimod 1 mg from Placebo|||28.1|-5.3|= 0.1309
72371113|NCT01901250|144252480|SUPERIORITY_OR_OTHER|||||||0.25|||||||Permutation test|Adjusted for child's gender, caries burden at study entry, surface-years at risk, and study cohort.||||||0.25
72371114|NCT01400880|144252507|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.98|STANDARD_DEVIATION|3.28|||TWO_SIDED|95.0|1.7|4.27||||||All subjects were monitored with the electrode sensor, TOCO and IUPC. Measurements were taken with the electrode sensor vs. IUPC and were also taken with TOCO vs. IUPC and those measurements were compared to each other. These results are for TOCO and IUPC. Agreement between TOCO and IUPC. Null hypothesis: the mean peak difference between TOCO and IUPC is equal to 0. Alternative hypothesis: the mean peak difference is not equal to 0.||4.27|1.70|
72371115|NCT01400880|144252507|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.95|STANDARD_DEVIATION|2.65|||TWO_SIDED|95.0|2.98|4.92||||||All subjects were monitored with the electrode sensor, TOCO and IUPC. Measurements were taken with the electrode sensor vs. IUPC and were also taken with TOCO vs. IUPC and those measurements were compared to each other. These results are for the electrode sensor and IUPC. Agreement between electrode sensor and IUPC. Null hypothesis: the mean peak difference between TOCO and IUPC is equal to 0. Alternative hypothesis: the mean peak difference is not equal to 0.||4.92|2.98|
72431927|NCT03230006|144376074|SUPERIORITY||Partial eta squared|0.342|||<|0.001|TWO_SIDED|95.0||||The threshold for significance is p \<.05.|ANOVA||This is the partial eta squared for the main effect of time.|||||<.001
72493087|NCT04986202|144514974|SUPERIORITY||Mean Difference (Final Values)|-1.04||||0.558|TWO_SIDED|95.0|-4.55|2.46||Two-sided test.|ANCOVA|Treatment group, neutrophil count stratification factor and the baseline value are included in the model as explanatory variables.|Difference in adjusted mean change from baseline between AZD4831 and placebo.|Change from baseline at 48 weeks||2.46|-4.55|0.558
72493088|NCT04986202|144514975|SUPERIORITY||Mean Difference (Final Values)|-2.2||||0.619|TWO_SIDED|95.0|-11.1|6.6||Two-sided test.|ANCOVA|Treatment group, neutrophil count stratification factor and the baseline value are included in the model as explanatory variables.|Difference in adjusted mean change from baseline between AZD4831 and placebo.|Change from baseline at 24 weeks||6.6|-11.1|0.619
72431928|NCT03230006|144376074|SUPERIORITY||Partial eta squared|0.018||||0.309|TWO_SIDED|95.0|||||ANOVA||This is the partial eta squared for the main effect of treatment condition.|||||.309
72431929|NCT03230006|144376074|OTHER||F|38.92|||<|0.001|TWO_SIDED|95.0||||The threshold for significance is p \<.05.|ANOVA|||After conducting the initial two-way mixed ANOVA, follow-up testing was conducted to determine the simple main effects of time (pre to post) on mean number of drinks per week within each treatment condition, which was examined using one-way repeated measures ANOVAs.||||<.001
72431930|NCT03230006|144376074|OTHER||F|5.43||||0.03|TWO_SIDED|95.0|||||ANOVA|||After conducting the initial two-way mixed ANOVA, follow-up testing was conducted to determine the simple main effects of time (pre to post) on mean number of drinks per week within each treatment condition, which was examined using one-way repeated measures ANOVAs.||||.030
72431931|NCT03230006|144376074|OTHER||F|1.15||||0.016|TWO_SIDED|95.0|||||ANOVA||This is the simple main effect of treatment condition on mean number of drinks consumed per week at baseline. For the UP, n=51; for the TC, n=24.|After conducting the initial two-way mixed ANOVA, the simple main effects for treatment condition on mean number of drinks consumed per week at each timepoint (pre and post) were examined using one-way ANOVAs.||||.016
72493089|NCT04986202|144514975|SUPERIORITY||Mean Difference (Final Values)|2.8||||0.522|TWO_SIDED|95.0|-5.8|11.4||Two-sided test.|ANCOVA|Treatment group, neutrophil count stratification factor and the baseline value are included in the model as explanatory variables.|Difference in adjusted mean change from baseline between AZD4831 and placebo.|Change from baseline at 24 weeks||11.4|-5.8|0.522
72493090|NCT04986202|144514975|SUPERIORITY||Mean Difference (Final Values)|5.7||||0.267|TWO_SIDED|95.0|-4.4|15.8||Two-sided test.|ANCOVA|Treatment group, neutrophil count stratification factor and the baseline value are included in the model as explanatory variables.|Difference in adjusted mean change from baseline between AZD4831 and placebo.|Change from baseline at 48 weeks||15.8|-4.4|0.267
72553936|NCT03570749|144640015|SUPERIORITY||Odds Ratio (OR)|10.26|||<|0.001|TWO_SIDED|95.0|5.05|20.87|||Regression, Logistic|||||20.87|5.05|<0.001
72553937|NCT03570749|144640016|SUPERIORITY||Odds Ratio (OR)|5.58||||0.001|TWO_SIDED|95.0|1.97|15.83|||Regression, Logistic|||||15.83|1.97|0.001
72553938|NCT03570749|144640016|SUPERIORITY||Odds Ratio (OR)|14.34|||<|0.001|TWO_SIDED|95.0|5.3|38.83|||Regression, Logistic|||||38.83|5.30|<0.001
72553939|NCT03570749|144640017|SUPERIORITY||Odds Ratio (OR)|10.34|||<|0.001|TWO_SIDED|95.0|2.72|39.3|||Regression, Logistic|||||39.30|2.72|<0.001
72431932|NCT03230006|144376074|OTHER||F|7.78||||0.007|TWO_SIDED|95.0|||||ANOVA||This is the simple main effect of treatment condition on mean number of drinks consumed per week at post-treatment. For the UP, n=38; for the TC, n=21.|After conducting the initial two-way mixed ANOVA, the simple main effects for treatment condition on mean number of drinks consumed per week at each timepoint (pre and post) were examined using one-way ANOVAs.||||.007
72431933|NCT04949399|144376076|SUPERIORITY||Difference (%)|30.4|||<|0.0001|TWO_SIDED|95.0|23.5|37.2||P-value derived from Cochran-Mantel-Haenszel (CMH) model stratified by investigator site and baseline C-APPS.|Cochran-Mantel-Haenszel|||||37.2|23.5|<.0001
72431934|NCT04949399|144376077|SUPERIORITY||Difference (%)|39.8|||<|0.0001|TWO_SIDED|95.0|32.0|47.7||P-value derived from Cochran-Mantel-Haenszel (CMH) model stratified by investigator site and baseline C-APPS.|Cochran-Mantel-Haenszel|||||47.7|32.0|<0.0001
72431935|NCT04949399|144376078|SUPERIORITY||Difference (%)|41.6|||<|0.0001|TWO_SIDED|95.0|33.7|49.6||P-value derived from Cochran-Mantel-Haenszel (CMH) model stratified by investigator site and baseline C-APPS.|Cochran-Mantel-Haenszel|||||49.6|33.7|<0.0001
72431936|NCT04949399|144376081|SUPERIORITY||Difference (%)|54.8|||<|0.0001|TWO_SIDED|95.0|46.8|62.8||P-value derived from Cochran-Mantel-Haenszel (CMH) model stratified by investigator site and baseline C-APPS.|Cochran-Mantel-Haenszel|||||62.8|46.8|<.0001
72431937|NCT04949399|144376082|SUPERIORITY||Difference (%)|39.1|||<|0.0001|TWO_SIDED|95.0|30.5|47.8||P-value derived from Cochran-Mantel-Haenszel (CMH) model stratified by investigator site and baseline C-APPS.|Cochran-Mantel-Haenszel|||||47.8|30.5|<.0001
72431938|NCT04949399|144376083|SUPERIORITY||Difference (%)|44.6|||<|0.0001|TWO_SIDED|95.0|36.8|52.5||P-value derived from Cochran-Mantel-Haenszel (CMH) model stratified by investigator site and baseline C-APPS.|Cochran-Mantel-Haenszel|||||52.5|36.8|<.0001
72431939|NCT04949399|144376084|SUPERIORITY||Difference (SE)|-5.7|STANDARD_ERROR_OF_MEAN|0.5|<|0.0001|TWO_SIDED|95.0|-6.7|-4.7||P-value derived from ANCOVA model stratified by investigator site and baseline C-APPS with baseline value as a factor.|ANCOVA|||||-4.7|-6.7|<.0001
72431940|NCT04949399|144376087|SUPERIORITY||Difference (%)|46.1|||<|0.0001|TWO_SIDED|96.0|38.1|54.2||P-value derived from Cochran-Mantel-Haenszel (CMH) model stratified by investigator site and baseline C-APPS.|Cochran-Mantel-Haenszel|||||54.2|38.1|<0.0001
72431941|NCT04949399|144376088|SUPERIORITY||Difference (%)|51.9|||<|0.0001|TWO_SIDED|95.0|43.3|60.5||P-value derived from Cochran-Mantel-Haenszel (CMH) model stratified by investigator site and baseline C-APPS.|Cochran-Mantel-Haenszel|||||60.5|43.3|<0.0001
72431942|NCT04949399|144376089|SUPERIORITY||Difference (%)|40.1|||<|0.0001|TWO_SIDED|95.0|31.3|49.0||P-value derived from Cochran-Mantel-Haenszel (CMH) model stratified by investigator site and baseline C-APPS.|Cochran-Mantel-Haenszel|||||49.0|31.3|<0.0001
72431943|NCT04949399|144376090|SUPERIORITY||Difference (%)|45.2|||<|0.0001|TWO_SIDED|95.0|37.1|53.2||P-value derived from Cochran-Mantel-Haenszel (CMH) model stratified by investigator site and baseline C-APPS.|Cochran-Mantel-Haenszel|||||53.2|37.1|<0.0001
72431944|NCT04949399|144376091|SUPERIORITY||Difference (SE)|-5.7|STANDARD_ERROR_OF_MEAN|0.54|<|0.0001|TWO_SIDED|95.0|-6.8|-4.6||P-value derived from ANCOVA model stratified by investigator site and baseline C-APPS with baseline value as a factor.|ANCOVA|||||-4.6|-6.8|<0.0001
72431945|NCT04949399|144376092|SUPERIORITY||Difference (SE)|-5.6|STANDARD_ERROR_OF_MEAN|0.55|<|0.0001|TWO_SIDED|95.0|-6.7|-4.5||P-value derived from ANCOVA model stratified by investigator site and baseline C-APPS with baseline value as a factor.|ANCOVA|||Day 30||-4.5|-6.7|<0.0001
72431946|NCT04949399|144376092|SUPERIORITY||Difference (SE)|-5.0|STANDARD_ERROR_OF_MEAN|0.54|<|0.0001|TWO_SIDED|95.0|-6.0|-3.9||P-value derived from ANCOVA model stratified by investigator site and baseline C-APPS with baseline value as a factor.|ANCOVA|||Day 60||-3.9|-6.0|<0.0001
72431947|NCT04949399|144376092|SUPERIORITY||Difference (SE)|-3.9|STANDARD_ERROR_OF_MEAN|0.55|<|0.0001|TWO_SIDED|95.0|-4.9|-2.8||P-value derived from ANCOVA model stratified by investigator site and baseline C-APPS with baseline value as a factor.|ANCOVA|||Day 90||-2.8|-4.9|<0.0001
72431948|NCT01866917|144376193|SUPERIORITY|||||||0.574|||||||Chi-squared|||||||.574
72493091|NCT04986202|144514975|SUPERIORITY||Mean Difference (Final Values)|2.2||||0.657|TWO_SIDED|95.0|-7.6|12.1||Two-sided test.|ANCOVA|Treatment group, neutrophil count stratification factor and the baseline value are included in the model as explanatory variables.|Difference in adjusted mean change from baseline between AZD4831 and placebo.|Change from baseline at 48 weeks||12.1|-7.6|0.657
72614846|NCT01201863|144759833|SUPERIORITY_OR_OTHER_LEGACY||Slope|0.07816|STANDARD_ERROR_OF_MEAN|1.3315||0.954|TWO_SIDED||||||comparison of slopes|Slopes by group and slope difference||To investigate a difference in change in outcome over time between treatment and control, a trend analysis was used in place of a profile analysis, where both control and treatment arms are described more parsimoniously i.e. by a slope (change in outcome over time) (Fitzmaurice 2011).||||0.9540
72371116|NCT02695420|144252540|SUPERIORITY||Treatment Difference|22.1|STANDARD_ERROR_OF_MEAN|6.3||0.0008|TWO_SIDED|95.0|9.6|34.7|||Repeated Measures Model|||||34.7|9.6|0.0008
72431949|NCT01866917|144376194|SUPERIORITY|Statistical analysis performed using SPSS software, version 15 (SPSS Inc., Chicago, IL). Data for quantitative variables reported as a median and interquartile range. The Mann Whitney and chi-square tests were used for the analysis of continuous and categorical variables.|Interquartile range (IQR)|3.0||||0.825|TWO_SIDED|||||Effect size was calculated for the numeric pain rating scale at the immediate post-operative period, 4-hour, 8-hour , 12-hour, and 24-hour time periods as a means to assess post-operative pain control.|Chi-squared|||TAP has been demonstrated to have a potential role in reducing pain, post-operative opioid requirement, and time to hospital discharge after abdominal hysterectomies and cesarean sections.||||.825
72431950|NCT00662909|144376205|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.34||||0.026|TWO_SIDED|95.0|-0.66|-0.03||The response variable for the stratified rank ANCOVA was standardized ranks on change from baseline to Final Visit value with baseline standardized ranks and gender as covariates and geographic region as a stratum.|Stratified rank ANCOVA|LS mean difference was derived from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.||Since there were 2 coprimary efficacy endpoints and 3 key secondary efficacy endpoints, the multiplicity among the endpoints was controlled at a type I error rate at the alpha = 0.05 level using a stepwise parallel gatekeeping procedure (5 stages). In addition, since two mirabegron treatment groups were compared with placebo per endpoint, the Hochberg procedure was used to adjust for multiplicity. A stratified rank ANCOVA model was utilized for hypothesis testing.||-0.03|-0.66|0.026
72469410|NCT01018732|144462514|SUPERIORITY_OR_OTHER||ratio of titer|0.52|||||TWO_SIDED|95.0|0.23|1.13|||ANOVA|||Day 8, Men C, Pairwise comparison of geometric mean titer||1.13|0.23|
72469411|NCT01018732|144462514|SUPERIORITY_OR_OTHER||ratio of titer|45.0|||||TWO_SIDED|95.0|21.0|97.0|||ANOVA|||Day 8, Men C, Pairwise comparison of geometric mean titer||97|21|
72469412|NCT01018732|144462514|SUPERIORITY_OR_OTHER||ratio of titer|23.0|||||TWO_SIDED|95.0|10.0|51.0|||ANOVA|||Day 8, Men C, Pairwise comparison of geometric mean titer||51|10|
72553940|NCT03570749|144640017|SUPERIORITY||Odds Ratio (OR)|18.47|||<|0.001|TWO_SIDED|95.0|5.04|67.68|||Regression, Logistic|||||67.68|5.04|<0.001
72553941|NCT03570749|144640018|SUPERIORITY||Odds Ratio (OR)|6.6|||<|0.001|TWO_SIDED|95.0|2.34|18.62|||Regression, Logistic|||||18.62|2.34|<0.001
72431951|NCT00662909|144376205|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.5|||<|0.001|TWO_SIDED|95.0|-0.82|-0.18||The response variable for the stratified rank ANCOVA was standardized ranks on change from baseline to Final Visit value with baseline standardized ranks and gender as covariates and geographic region as a stratum.|Stratified rank ANCOVA|LS mean difference was derived from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.||Since there were 2 coprimary efficacy endpoints and 3 key secondary efficacy endpoints, the multiplicity among the endpoints was controlled at a type I error rate at the alpha = 0.05 level using a stepwise parallel gatekeeping procedure (5 stages). In addition, since two mirabegron treatment groups were compared with placebo per endpoint, the Hochberg procedure was used to adjust for multiplicity. A stratified rank ANCOVA model was utilized for hypothesis testing.||-0.18|-0.82|<0.001
72431952|NCT00662909|144376206|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.61||||0.001|TWO_SIDED|95.0|-0.98|-0.24||LS mean difference and p-value were derived from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|ANCOVA|||Since there were 2 coprimary efficacy endpoints and 3 key secondary efficacy endpoints, the multiplicity among the endpoints was controlled at a type I error rate at the alpha = 0.05 level using a stepwise parallel gatekeeping procedure (5 stages). In addition, since two mirabegron treatment groups were compared with placebo per endpoint, the Hochberg procedure was used to adjust for multiplicity. An ANCOVA model was used for hypothesis testing.||-0.24|-0.98|0.001
72431953|NCT00662909|144376206|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.7|||<|0.001|TWO_SIDED|95.0|-1.07|-0.33||LS mean difference and p-value were derived from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|ANCOVA|||Since there were 2 coprimary efficacy endpoints and 3 key secondary efficacy endpoints, the multiplicity among the endpoints was controlled at a type I error rate at the alpha = 0.05 level using a stepwise parallel gatekeeping procedure (5 stages). In addition, since two mirabegron treatment groups were compared with placebo per endpoint, the Hochberg procedure was used to adjust for multiplicity. An ANCOVA model was used for hypothesis testing.||-0.33|-1.07|<0.001
72431954|NCT00662909|144376207|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|11.1||||0.001|TWO_SIDED|95.0|4.4|17.9||LS mean difference and p-value were derived from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|ANCOVA|||Since there were 2 coprimary efficacy endpoints and 3 key secondary efficacy endpoints, the multiplicity among the endpoints was controlled at a type I error rate at the alpha = 0.05 level using a stepwise parallel gatekeeping procedure (5 stages). In addition, since two mirabegron treatment groups were compared with placebo per endpoint, the Hochberg procedure was used to adjust for multiplicity. An ANCOVA model was used for hypothesis testing.||17.9|4.4|0.001
72469413|NCT01018732|144462514|SUPERIORITY_OR_OTHER||ratio of titer|0.4|||||TWO_SIDED|95.0|0.2|0.82|||ANOVA|||Day 29, Men C, Pairwise comparison of geometric mean titer||0.82|0.2|
72493092|NCT04986202|144514976|SUPERIORITY||Geometric mean ratio|0.95||||0.312|TWO_SIDED|95.0|0.86|1.05||Two-sided test.|ANCOVA|Treatment group, neutrophil count stratification factor and the log-transformed baseline value are included in the model as explanatory variables.|Geometric mean ratio in change from baseline between AZD4831 and placebo.|NT-proBNP change from baseline at 16 weeks||1.05|0.86|0.312
72493093|NCT04986202|144514976|SUPERIORITY||Geometric mean ratio|0.91||||0.07|TWO_SIDED|95.0|0.83|1.01||Two-sided test.|ANCOVA|Treatment group, neutrophil count stratification factor and the log-transformed baseline value are included in the model as explanatory variables.|Geometric mean ratio in change from baseline between AZD4831 and placebo.|NT-proBNP change from baseline at 16 weeks||1.01|0.83|0.070
72493094|NCT04986202|144514976|SUPERIORITY||Geometric mean ratio|1.01||||0.911|TWO_SIDED|95.0|0.91|1.12||Two-sided test.|ANCOVA|Treatment group, neutrophil count stratification factor and the log-transformed baseline value are included in the model as explanatory variables.|Geometric mean ratio in change from baseline between AZD4831 and placebo.|NT-proBNP change from baseline at 24 weeks||1.12|0.91|0.911
72493095|NCT04986202|144514976|SUPERIORITY||Geometric mean ratio|1.01||||0.837|TWO_SIDED|95.0|0.91|1.12||Two-sided test.|ANCOVA|Treatment group, neutrophil count stratification factor and the log-transformed baseline value are included in the model as explanatory variables.|Geometric mean ratio in change from baseline between AZD4831 and placebo.|NT-proBNP change from baseline at 24 weeks||1.12|0.91|0.837
72493096|NCT04986202|144514976|SUPERIORITY||Geometric mean ratio|0.95||||0.37|TWO_SIDED|95.0|0.84|1.07||Two-sided test.|ANCOVA|Treatment group, neutrophil count stratification factor and the log-transformed baseline value are included in the model as explanatory variables.|Geometric mean ratio in change from baseline between AZD4831 and placebo.|NT-proBNP change from baseline at 48 weeks||1.07|0.84|0.370
72493097|NCT04986202|144514976|SUPERIORITY||Geometric mean ratio|0.93||||0.205|TWO_SIDED|95.0|0.83|1.04||Two-sided test.|ANCOVA|Treatment group, neutrophil count stratification factor and the log-transformed baseline value are included in the model as explanatory variables.|Geometric mean ratio in change from baseline between AZD4831 and placebo.|NT-proBNP change from baseline at 48 weeks||1.04|0.83|0.205
72493098|NCT04986202|144514977|SUPERIORITY||Mean Difference (Final Values)|0.5||||0.183|TWO_SIDED|95.0|-0.2|1.2||Two-sided test.|ANCOVA|Treatment group, neutrophil count stratification factor and the baseline value are included in the model as explanatory variables.|Difference in adjusted mean change from baseline between AZD4831 and placebo.|Change from baseline at 16 weeks||1.2|-0.2|0.183
72493099|NCT04986202|144514977|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.898|TWO_SIDED|95.0|-0.8|0.7||Two-sided test.|ANCOVA|Treatment group, neutrophil count stratification factor and the baseline value are included in the model as explanatory variables.|Difference in adjusted mean change from baseline between AZD4831 and placebo.|Change from baseline at 16 weeks||0.7|-0.8|0.898
72553942|NCT03570749|144640018|SUPERIORITY||Odds Ratio (OR)|13.58|||<|0.001|TWO_SIDED|95.0|5.01|36.81|||Regression, Logistic|||||36.81|5.01|<0.001
72553943|NCT03570749|144640019|SUPERIORITY||Odds Ratio (OR)|4.63||||0.012|TWO_SIDED|95.0|1.41|15.27|||Regression, Logistic|||||15.27|1.41|0.012
72553944|NCT03570749|144640019|SUPERIORITY||Odds Ratio (OR)|14.42|||<|0.001|TWO_SIDED|95.0|4.73|43.93|||Regression, Logistic|||||43.93|4.73|<0.001
72553945|NCT03570749|144640020|SUPERIORITY||Mean Difference (Final Values)|-23.1|STANDARD_ERROR_OF_MEAN|3.806|<|0.001|TWO_SIDED|95.0|-30.57|-15.63|||ANCOVA|||||-15.63|-30.57|<0.001
72553946|NCT03570749|144640020|SUPERIORITY||Mean Difference (Final Values)|-37.65|STANDARD_ERROR_OF_MEAN|3.447|<|0.001|TWO_SIDED|95.0|-44.24|-30.89|||ANCOVA|||||-30.89|-44.24|<0.001
72493100|NCT04986202|144514977|SUPERIORITY||Mean Difference (Final Values)|0.4||||0.316|TWO_SIDED|95.0|-0.4|1.1||Two-sided test.|ANCOVA|Treatment group, neutrophil count stratification factor and the baseline value are included in the model as explanatory variables.|Difference in adjusted mean change from baseline between AZD4831 and placebo.|Change from baseline at 24 weeks||1.1|-0.4|0.316
72493101|NCT04986202|144514977|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.934|TWO_SIDED|95.0|-0.7|0.8||Two-sided test.|ANCOVA|Treatment group, neutrophil count stratification factor and the baseline value are included in the model as explanatory variables.|Difference in adjusted mean change from baseline between AZD4831 and placebo.|Change from baseline at 24 weeks||0.8|-0.7|0.934
72493102|NCT04986202|144514978|SUPERIORITY||Mean Difference (Final Values)|0.36||||0.725|TWO_SIDED|95.0|-1.647|2.366||Two-sided test.|ANCOVA|Treatment group, neutrophil count stratification factor and the baseline value are included in the model as explanatory variables.|Difference in adjusted mean change from baseline between AZD4831 and placebo.|Change from baseline at 16 weeks||2.366|-1.647|0.725
72431955|NCT00662909|144376207|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|11.0||||0.002|TWO_SIDED|95.0|4.2|17.7||LS mean difference and p-value were derived from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|ANCOVA|||Since there were 2 coprimary efficacy endpoints and 3 key secondary efficacy endpoints, the multiplicity among the endpoints was controlled at a type I error rate at the alpha = 0.05 level using a stepwise parallel gatekeeping procedure (5 stages). In addition, since two mirabegron treatment groups were compared with placebo per endpoint, the Hochberg procedure was used to adjust for multiplicity. An ANCOVA model was used for hypothesis testing.||17.7|4.2|0.002
72431956|NCT00662909|144376208|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.48||||0.003|TWO_SIDED|95.0|-0.8|-0.15||The response variable for the stratified rank ANCOVA was standardized ranks on change from baseline to Final Visit value with baseline standardized ranks and gender as covariates and geographic region as a stratum.|Stratified rank ANCOVA|LS mean difference was derived from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.||Since there were 2 coprimary efficacy endpoints and 3 key secondary efficacy endpoints, the multiplicity among the endpoints was controlled at a type I error rate at the alpha = 0.05 level using a stepwise parallel gatekeeping procedure (5 stages). In addition, since two mirabegron treatment groups were compared with placebo per endpoint, the Hochberg procedure was used to adjust for multiplicity. A stratified rank ANCOVA model was utilized for hypothesis testing.||-0.15|-0.80|0.003
72431957|NCT00662909|144376208|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.46|||<|0.001|TWO_SIDED|95.0|-0.79|-0.13||The response variable for the stratified rank ANCOVA was standardized ranks on change from baseline to Final Visit value with baseline standardized ranks and gender as covariates and geographic region as a stratum.|Stratified rank ANCOVA|LS mean difference was derived from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.||Since there were 2 coprimary efficacy endpoints and 3 key secondary efficacy endpoints, the multiplicity among the endpoints was controlled at a type I error rate at the alpha = 0.05 level using a stepwise parallel gatekeeping procedure (5 stages). In addition, since two mirabegron treatment groups were compared with placebo per endpoint, the Hochberg procedure was used to adjust for multiplicity. A stratified rank ANCOVA model was utilized for hypothesis testing.||-0.13|-0.79|<0.001
72431958|NCT00662909|144376209|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.42||||0.022|TWO_SIDED|95.0|-0.77|-0.06||LS mean difference and p-value were derived from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|ANCOVA|||Since there were 2 coprimary efficacy endpoints and 3 key secondary efficacy endpoints, the multiplicity among the endpoints was controlled at a type I error rate at the alpha = 0.05 level using a stepwise parallel gatekeeping procedure (5 stages). In addition, since two mirabegron treatment groups were compared with placebo per endpoint, the Hochberg procedure was used to adjust for multiplicity. An ANCOVA model was used for hypothesis testing.||-0.06|-0.77|0.022
72431959|NCT00662909|144376209|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.6||||0.001|TWO_SIDED|95.0|-0.96|-0.24||LS mean difference and p-value were derived from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|ANCOVA|||Since there were 2 coprimary efficacy endpoints and 3 key secondary efficacy endpoints, the multiplicity among the endpoints was controlled at a type I error rate at the alpha = 0.05 level using a stepwise parallel gatekeeping procedure (5 stages). In addition, since two mirabegron treatment groups were compared with placebo per endpoint, the Hochberg procedure was used to adjust for multiplicity. An ANCOVA model was used for hypothesis testing.||-0.24|-0.96|0.001
72469414|NCT01018732|144462514|SUPERIORITY_OR_OTHER||ratio of titer|24.0|||||TWO_SIDED|95.0|12.0|48.0|||ANOVA|||Day 29, Men C, Pairwise comparison of geometric mean titer||48|12|
72493103|NCT04986202|144514978|SUPERIORITY||Mean Difference (Final Values)|-0.594||||0.555|TWO_SIDED|95.0|-2.571|1.382||Two-sided test.|ANCOVA|Treatment group, neutrophil count stratification factor and the baseline value are included in the model as explanatory variables.|Difference in adjusted mean change from baseline between AZD4831 and placebo.|Change from baseline at 16 weeks||1.382|-2.571|0.555
72493104|NCT04986202|144514978|SUPERIORITY||Mean Difference (Final Values)|0.657||||0.586|TWO_SIDED|95.0|-1.71|3.025||Two-sided test.|ANCOVA|Treatment group, neutrophil count stratification factor and the baseline value are included in the model as explanatory variables.|Difference in adjusted mean change from baseline between AZD4831 and placebo.|Change from baseline at 24 weeks||3.025|-1.710|0.586
72493105|NCT04986202|144514978|SUPERIORITY||Mean Difference (Final Values)|-0.815||||0.486|TWO_SIDED|95.0|-3.108|1.478||Two-sided test.|ANCOVA|Treatment group, neutrophil count stratification factor and the baseline value are included in the model as explanatory variables.|Difference in adjusted mean change from baseline between AZD4831 and placebo.|Change from baseline at 24 weeks||1.478|-3.108|0.486
72493106|NCT04986202|144514979|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.968|TWO_SIDED|95.0|-4.1|3.9||Two-sided test.|ANCOVA|Treatment group, neutrophil count stratification factor and the baseline value are included in the model as explanatory variables.|Difference in adjusted mean change from baseline between AZD4831 and placebo.|Change from baseline at 16 weeks||3.9|-4.1|0.968
72553947|NCT03570749|144640021|SUPERIORITY||Odds Ratio (OR)|2.31||||0.047|TWO_SIDED|95.0|1.01|5.29|||Regression, Logistic|||||5.29|1.01|0.047
72371117|NCT02695420|144252540|SUPERIORITY||Treatment Difference|29.3|STANDARD_ERROR_OF_MEAN|6.5|<|0.0001|TWO_SIDED|95.0|16.3|42.3|||Repeated measures model|||||42.3|16.3|< 0.0001
72469415|NCT01018732|144462514|SUPERIORITY_OR_OTHER||ratio of titer|9.61|||||TWO_SIDED|95.0|4.69|20.0|||ANOVA|||Day 29, Men C, Pairwise comparison of geometric mean titer||20|4.69|
72493107|NCT04986202|144514979|SUPERIORITY||Mean Difference (Final Values)|-2.3||||0.251|TWO_SIDED|95.0|-6.3|1.6||Two-sided test.|ANCOVA|Treatment group, neutrophil count stratification factor and the baseline value are included in the model as explanatory variables.|Difference in adjusted mean change from baseline between AZD4831 and placebo.|Change from baseline at 16 weeks||1.6|-6.3|0.251
72493108|NCT04986202|144514979|SUPERIORITY||Mean Difference (Final Values)|0.4||||0.872|TWO_SIDED|95.0|-4.8|5.7||Two-sided test.|ANCOVA|Treatment group, neutrophil count stratification factor and the baseline value are included in the model as explanatory variables.|Difference in adjusted mean change from baseline between AZD4831 and placebo.|Change from baseline at 24 weeks||5.7|-4.8|0.872
72493109|NCT04986202|144514979|SUPERIORITY||Mean Difference (Final Values)|-1.1||||0.682|TWO_SIDED|95.0|-6.2|4.1||Two-sided test.|ANCOVA|Treatment group, neutrophil count stratification factor and the baseline value are included in the model as explanatory variables.|No formal hypothesis testing and p-value is not adjusted for multiple comparisons.|Change from baseline at 24 weeks||4.1|-6.2|0.682
72493110|NCT04986202|144514981|SUPERIORITY||Geometric mean ratio|1.029||||0.76|TWO_SIDED|95.0|0.857|1.236||Two-sided test.|ANCOVA|Treatment group, neutrophil count stratification factor and the log-transformed baseline value are included in the model as explanatory variables.|Geometric mean ratio in change from baseline between AZD4831 and placebo.|Change from baseline at 16 weeks||1.236|0.857|0.760
72493111|NCT04986202|144514981|SUPERIORITY||Geometric mean ratio|1.209||||0.039|TWO_SIDED|95.0|1.01|1.448||Two-sided test.|ANCOVA|Treatment group, neutrophil count stratification factor and the baseline value are included in the model as explanatory variables.|Treatment group, neutrophil count stratification factor and the log-transformed baseline value are included in the model as explanatory variables.|Change from baseline at 16 weeks||1.448|1.010|0.039
72493112|NCT04986202|144514981|SUPERIORITY||Geometric mean ratio|1.111||||0.241|TWO_SIDED|95.0|0.931|1.326||Two-sided test.|ANCOVA|Treatment group, neutrophil count stratification factor and the log-transformed baseline value are included in the model as explanatory variables.|Geometric mean ratio in change from baseline between AZD4831 and placebo.|Change from baseline at 24 weeks||1.326|0.931|0.241
72493113|NCT04986202|144514981|SUPERIORITY||Geometric mean ratio|1.19||||0.049|TWO_SIDED|95.0|1.001|1.414||Two-sided test.|ANCOVA|Treatment group, neutrophil count stratification factor and the log-transformed baseline value are included in the model as explanatory variables.|Geometric mean ratio in change from baseline between AZD4831 and placebo.|Change from baseline at 24 weeks||1.414|1.001|0.049
72493114|NCT04986202|144514981|SUPERIORITY||Geometric mean ratio|1.151||||0.158|TWO_SIDED|95.0|0.946|1.401||Two-sided test.|ANCOVA|Treatment group, neutrophil count stratification factor and the log-transformed baseline value are included in the model as explanatory variables.|Geometric mean ratio in change from baseline between AZD4831 and placebo.|Change from baseline at 48 weeks||1.401|0.946|0.158
72493115|NCT04986202|144514981|SUPERIORITY||Geometric mean ratio|1.159||||0.131|TWO_SIDED|95.0|0.957|1.404||Two-sided test.|ANCOVA|Treatment group, neutrophil count stratification factor and the log-transformed baseline value are included in the model as explanatory variables.|Geometric mean ratio in change from baseline between AZD4831 and placebo.|Change from baseline at 48 weeks||1.404|0.957|0.131
72493116|NCT04986202|144514982|SUPERIORITY||Geometric mean ratio|1.0111||||0.874|TWO_SIDED|95.0|0.8819|1.1592||Two-sided test.|ANCOVA|Treatment group, neutrophil count stratification factor and the log-transformed baseline value are included in the model as explanatory variables.|Geometric mean ratio in change from baseline between AZD4831 and placebo.|Change from baseline at 16 weeks||1.1592|0.8819|0.874
72614847|NCT00898807|144759846|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.93||||0.036|TWO_SIDED|95.0|-1.8|-0.06||P-value was not adjusted for multiple comparisons. All p-values are two-sided and p\<0.05 was the threshold for statistical significance.|Mixed Models Analysis|Mixed effects model w/ random intercept for patient, visit indicator, treatment by visit interactions and adjusted for baseline NBRS-A \& cognition.|Negative numbers favor citalopram group.|Primary assessment of efficacy was based on intention-to-treat comparison of the difference in the NBRS-A scores at week 9 and comparison at week 9 for the CGIC. For the NBRS-A, the study was designed to have 85% power to detect a standardized difference at week 9 of 40% for citalopram compared to placebo at week 9.||-0.06|-1.80|0.036
72493117|NCT04986202|144514982|SUPERIORITY||Geometric mean ratio|0.9157||||0.2|TWO_SIDED|95.0|0.8002|1.0479||Two-sided test.|ANCOVA|Treatment group, neutrophil count stratification factor and the log-transformed baseline value are included in the model as explanatory variables.|Geometric mean ratio in change from baseline between AZD4831 and placebo.|Change from baseline at 16 weeks||1.0479|0.8002|0.200
72493118|NCT04986202|144514982|SUPERIORITY||Geometric mean ratio|1.1063||||0.135|TWO_SIDED|95.0|0.969|1.2631||Two-sided test.|ANCOVA|Treatment group, neutrophil count stratification factor and the log-transformed baseline value are included in the model as explanatory variables.|Geometric mean ratio in change from baseline between AZD4831 and placebo.|Change from baseline at 24 weeks||1.2631|0.9690|0.135
72493119|NCT04986202|144514982|SUPERIORITY||Geometric mean ratio|1.0842||||0.22|TWO_SIDED|95.0|0.9527|1.2339||Two-sided test.|ANCOVA|Treatment group, neutrophil count stratification factor and the log-transformed baseline value are included in the model as explanatory variables.|Geometric mean ratio in change from baseline between AZD4831 and placebo.|Change from baseline at 24 weeks||1.2339|0.9527|0.220
72493120|NCT04986202|144514982|SUPERIORITY||Geometric mean ratio|1.0496||||0.467|TWO_SIDED|95.0|0.9211|1.196||Two-sided test.|ANCOVA|Treatment group, neutrophil count stratification factor and the log-transformed baseline value are included in the model as explanatory variables.|Geometric mean ratio in change from baseline between AZD4831 and placebo.|Change from baseline at 48 weeks||1.1960|0.9211|0.467
72493121|NCT04986202|144514982|SUPERIORITY||Geometric mean ratio|1.0312||||0.636|TWO_SIDED|95.0|0.908|1.1711||Two-sided test.|ANCOVA|Treatment group, neutrophil count stratification factor and the log-transformed baseline value are included in the model as explanatory variables.|Geometric mean ratio in change from baseline between AZD4831 and placebo.|Change from baseline at 48 weeks||1.1711|0.9080|0.636
72493122|NCT02787863|144514988|OTHER||||||<|0.05|||||||McNemar|||||||<0.05
72469416|NCT01018732|144462514|SUPERIORITY_OR_OTHER||ratio of titer|1.11|||||TWO_SIDED|95.0|0.55|2.21|||ANOVA|||Day 1, Men W-135, Pairwise comparison of geometric mean titer||2.21|0.55|
72493123|NCT02787863|144514989|OTHER||||||<|0.05|||||||McNemar|||||||<0.05
72493124|NCT01885000|144514999|SUPERIORITY||||||=|0.0065|||||||Cochran-Mantel-Haenszel|||||||= 0.0065
72493125|NCT01885000|144515000|SUPERIORITY||||||=|0.0328|||||||Cochran-Mantel-Haenszel|||The questionnaire analyzed and reported here is for participants who satisfied with appearance.||||= 0.0328
72493126|NCT01885000|144515000|SUPERIORITY||||||=|0.5312|||||||Cochran-Mantel-Haenszel|||The questionnaire analyzed and reported here is for participants who appearance acceptable.||||= 0.5312
72493127|NCT01885000|144515000|SUPERIORITY||||||=|0.0756|||||||Cochran-Mantel-Haenszel|||The questionnaire analyzed and reported here is for participants who appearance concerned.||||= 0.0756
72493128|NCT01885000|144515000|SUPERIORITY||||||=|0.0083|||||||Cochran-Mantel-Haenszel|||The questionnaire analyzed and reported here is for participants who embarrassed with facial redness.||||= 0.0083
72493129|NCT01885000|144515000|SUPERIORITY||||||=|0.0076|||||||Cochran-Mantel-Haenszel|||The questionnaire analyzed and reported here is for participants who self-conscious.||||= 0.0076
72493130|NCT01885000|144515000|SUPERIORITY||||||=|0.2186|||||||Cochran-Mantel-Haenszel|||The questionnaire analyzed and reported here is for participants who's frequency control last 24 hours||||= 0.2186
72493131|NCT01885000|144515000|SUPERIORITY||||||=|0.2373|||||||Cochran-Mantel-Haenszel|||The questionnaire analyzed and reported here is for participants who are frustrated.||||= 0.2373
72493132|NCT01885000|144515000|SUPERIORITY||||||=|0.7769|||||||Cochran-Mantel-Haenszel|||The questionnaire analyzed and reported here is for participants who cover up or camouflage.||||= 0.7769
72493133|NCT01885000|144515000|SUPERIORITY||||||=|0.8764|||||||Cochran-Mantel-Haenszel|||The questionnaire analyzed and reported here is for participants who pay attention to the known triggers.||||= 0.8764
72493134|NCT01885000|144515000|SUPERIORITY||||||=|0.6149|||||||Cochran-Mantel-Haenszel|||The questionnaire analyzed and reported here is for participants who avoid the known triggers.||||= 0.6149
72493135|NCT01885000|144515000|SUPERIORITY||||||=|0.8361|||||||Cochran-Mantel-Haenszel|||The questionnaire analyzed and reported here is for participants who interfering with social life.||||= 0.8361
72493136|NCT01885000|144515000|SUPERIORITY||||||=|0.6259|||||||Cochran-Mantel-Haenszel|||Interfering with work life||||= 0.6259
72493137|NCT01885000|144515001|SUPERIORITY||||||=|0.5821|||||||Cochran-Mantel-Haenszel|||This analysis was performed for Mobility.||||= 0.5821
72493138|NCT01885000|144515001|SUPERIORITY||||||=|0.8864|||||||Cochran-Mantel-Haenszel|||This analysis was performed for Self-Care.||||= 0.8864
72493139|NCT01885000|144515001|SUPERIORITY||||||=|0.9579|||||||Cochran-Mantel-Haenszel|||This analysis was performed for usual activities.||||= 0.9579
72493140|NCT01885000|144515001|SUPERIORITY||||||=|0.1344|||||||Cochran-Mantel-Haenszel|||This analysis was performed for Pain/Discomfort.||||= 0.1344
72493141|NCT01885000|144515001|SUPERIORITY||||||=|0.1881|||||||Cochran-Mantel-Haenszel|||Anxiety/Depression||||= 0.1881
72622150|NCT04003142|144774326|SUPERIORITY||Odds Ratio (OR)|4.217||||0.028|TWO_SIDED|95.0|1.305|18.806||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 5||18.806|1.305|0.028
72493142|NCT01885000|144515002|SUPERIORITY||||||=|0.3935|||||||Cochran-Mantel-Haenszel|||||||= 0.3935
72493143|NCT01885000|144515003|SUPERIORITY||||||=|0.4162|||||||Cochran-Mantel-Haenszel|||||||= 0.4162
72493144|NCT03124784|144515008|EQUIVALENCE|ARMS\<= 3 %SpO2 Error per International Organization For Standardization (ISO) -80601-2-61 Pilot study Monte Carlo simulation provided 80% Power with 25 subjects for an expected ARMS\< 3 % SpO2.|ARMS|0.0|||||TWO_SIDED|||||||||Accuracy Root Mean Square (ARMS)|Per ISO-80601-2-61, the Root Mean Square difference (SpO2-SaO2) is the measure of merit for desaturation studies.|||
72493145|NCT02163434|144515017|SUPERIORITY|||||||0.01|||||||Mixed Models Analysis|||||||0.01
72493146|NCT02163434|144515018|SUPERIORITY|||||||0.005|||||||Mixed Models Analysis|||||||0.005
72493147|NCT02163434|144515019|SUPERIORITY|||||||0.01|||||||Mixed Models Analysis|||||||0.01
72493148|NCT02163434|144515021|SUPERIORITY|||||||0.03|||||||Mixed Models Analysis|||||||0.03
72493149|NCT02163434|144515022|SUPERIORITY|||||||0.06|||||||Mixed Models Analysis|||||||0.06
72493150|NCT04283123|144515044|OTHER|Wilcoxon-signed rank test to compare differences from pretest to posttest for the treatment group. The standardized effect size was interpreted using Cohen's criteria.|Cohen's d|0.41|||||TWO_SIDED||||||||Wilcoxon-signed rank test to compare differences from pretest to posttest for the treatment group. The standardized effect size was interpreted using Cohen's criteria.|||||
72493151|NCT04283123|144515044|OTHER|Wilcoxon-signed rank test to compare differences from pretest to posttest for the waitlist control group. The standardized effect size was interpreted using Cohen's criteria.|Cohen's d|0.45|||||TWO_SIDED||||||||Wilcoxon-signed rank test to compare differences from pretest to posttest for the waitlist control group. The standardized effect size was interpreted using Cohen's criteria.|||||
72493152|NCT04283123|144515045|OTHER|Wilcoxon-signed rank test to compare differences from pretest to posttest for the treatment group. The standardized effect size was interpreted using Cohen's criteria.|Cohen's d|0.48|||||TWO_SIDED||||||||Wilcoxon-signed rank test to compare differences from pretest to posttest for the treatment group. The standardized effect size was interpreted using Cohen's criteria.|||||
72493153|NCT04283123|144515045|OTHER|Wilcoxon-signed rank test to compare differences from pretest to posttest for the waitlist control group. The standardized effect size was interpreted using Cohen's criteria.|Cohen's d|0.32|||||TWO_SIDED||||||||Wilcoxon-signed rank test to compare differences from pretest to posttest for the waitlist control group. The standardized effect size was interpreted using Cohen's criteria.|||||
72493154|NCT04283123|144515046|OTHER|Wilcoxon-signed rank test to compare differences from pretest to posttest for the treatment group. The standardized effect size was interpreted using Cohen's criteria.|Cohen's d|0.6|||||TWO_SIDED||||||||Wilcoxon-signed rank test to compare differences from pretest to posttest for the treatment group. The standardized effect size was interpreted using Cohen's criteria.|||||
72493155|NCT04283123|144515046|OTHER|Wilcoxon-signed rank test to compare differences from pretest to posttest for the waitlist control group. The standardized effect size was interpreted using Cohen's criteria.|Cohen's d|0.12|||||TWO_SIDED||||||||Wilcoxon-signed rank test to compare differences from pretest to posttest for the waitlist control group. The standardized effect size was interpreted using Cohen's criteria.|||||
72493156|NCT01415752|144515053|SUPERIORITY|||||||0.25||||||one-sided stratified log-rank test|Log Rank|one-sided stratified log-rank test||||||0.25
72493157|NCT01415752|144515054|SUPERIORITY|||||||0.178||||||one-sided stratified log-rank test|Log Rank|one-sided stratified log-rank test||||||0.178
72493158|NCT01903837|144515080|EQUIVALENCE|Equivalence margin of 10 points|Least Square Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|1.17||0.3|TWO_SIDED|95.0|-2.0|2.6|||Least Square Mean Difference|||||2.6|-2.0|0.3
72493159|NCT01903837|144515081|SUPERIORITY|||||||0.006|||||||Mixed Models Analysis|||||||0.006
72431960|NCT01251614|144376279|SUPERIORITY_OR_OTHER||Difference|-25.5||||0.027|TWO_SIDED|95.0|-47.2|-3.7|||Chi-squared|||"The a priori defined order of the statistical hypotheses was as follows:~1. Superiority of adalimumab 0.8 mg/kg versus MTX for the percentage of participants achieving a ≥ PASI 75 response at Week 16.~2. Superiority of adalimumab 0.8 mg/kg versus MTX, for the percentage of participants achieving a PGA cleared or minimal at Week 16.~This order was adhered to for confirmatory testing, all statistical tests were at a level of significance of 5% and the overall type I error was preserved."||-3.7|-47.2|0.027
72431961|NCT01251614|144376280|SUPERIORITY_OR_OTHER||Difference|-20.0||||0.083|TWO_SIDED|95.0|-42.2|2.2|||Chi-squared|||"The a priori defined order of the statistical hypotheses was as follows:~1. Superiority of adalimumab 0.8 mg/kg versus MTX for the percentage of participants achieving a ≥ PASI 75 response at Week 16.~2. Superiority of adalimumab 0.8 mg/kg versus MTX, for the percentage of participants achieving a PGA cleared or minimal at Week 16.~This order was adhered to for confirmatory testing, all statistical tests were at a level of significance of 5% and the overall type I error was preserved."||2.2|-42.2|0.083
72431962|NCT01251614|144376281|SUPERIORITY_OR_OTHER||Difference|-7.3||||0.466|TWO_SIDED|95.0|-26.9|12.3|||Chi-squared|||Statistical comparisons for the ranked secondary endpoints were carried out in hierarchical order. All statistical tests were 2-sided with the significance level of 5%. Statistically significant results (p-value ≤ 0.05) must have been achieved for a comparison in the higher rank in order to initiate the next comparison in the lower rank.||12.3|-26.9|0.466
72431963|NCT01251614|144376282|SUPERIORITY_OR_OTHER||Difference|-15.7||||0.056|TWO_SIDED|95.0|-29.1|-2.3|||Fisher Exact|||Statistical comparisons for the ranked secondary endpoints were carried out in hierarchical order. All statistical tests were 2-sided with the significance level of 5%. Statistically significant results (p-value ≤ 0.05) must have been achieved for a comparison in the higher rank in order to initiate the next comparison in the lower rank.||-2.3|-29.1|0.056
72493160|NCT01903837|144515081|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
72493161|NCT01903837|144515082|SUPERIORITY|||||||0.018|||||||Mixed Models Analysis|||||||0.018
72493162|NCT01903837|144515082|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
72493163|NCT03987854|144515179|SUPERIORITY||paired t-test|-7.67|STANDARD_DEVIATION|6.1|<|0.001|TWO_SIDED|||||-6.16|t-test, 2 sided|||||||<.001
72493164|NCT03987854|144515180|SUPERIORITY||paired t-test|-0.21|STANDARD_DEVIATION|0.27||0.001|TWO_SIDED|||||-3.29|t-test, 2 sided|||||||.001
72493165|NCT03987854|144515181|SUPERIORITY||paired t-test|1.92|STANDARD_DEVIATION|1.17|<|0.001|TWO_SIDED|||||7.52|t-test, 2 sided|||||||<.001
72493166|NCT03987854|144515182|SUPERIORITY||paired t-test|1.14|STANDARD_DEVIATION|1.04|<|0.001|TWO_SIDED|||||5.03|t-test, 2 sided|||||||<.001
72493167|NCT03987854|144515183|SUPERIORITY||paired t-test|2.52|STANDARD_DEVIATION|1.7|<|0.001|TWO_SIDED|||||6.81|t-test, 2 sided|||||||<.001
72493168|NCT03987854|144515184|SUPERIORITY||paired t-test|1.08|STANDARD_DEVIATION|1.43||0.003|TWO_SIDED|||||3.46|t-test, 2 sided|||||||.003
72493169|NCT03987854|144515185|SUPERIORITY||paired t-test|1.11|STANDARD_DEVIATION|1.56||0.004|TWO_SIDED|||||3.26|t-test, 2 sided|||||||.004
72493170|NCT03987854|144515186|SUPERIORITY||paired t-test|2.1|STANDARD_DEVIATION|2.76||0.002|TWO_SIDED|||||3.49|t-test, 2 sided|||||||.002
72493171|NCT01459705|144515229|SUPERIORITY_OR_OTHER||Slope|-22.34|STANDARD_DEVIATION|4.69|||ONE_SIDED|||||||||||||
72493172|NCT01459705|144515229|SUPERIORITY_OR_OTHER||Slope|-13.3|STANDARD_ERROR_OF_MEAN|4.77|||TWO_SIDED|||||||||||||
72493173|NCT01459705|144515229|SUPERIORITY_OR_OTHER||Slope|9.04|STANDARD_ERROR_OF_MEAN|5.11|||TWO_SIDED|||||||||||||
72493174|NCT01459705|144515230|SUPERIORITY_OR_OTHER||Slope|15.07|STANDARD_DEVIATION|6.03|||TWO_SIDED|||||||||||||
72493175|NCT01459705|144515231|SUPERIORITY_OR_OTHER||Slope|13.91|STANDARD_ERROR_OF_MEAN|6.7|||TWO_SIDED|||||||||||||
72493176|NCT02171611|144515317|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|175.14|STANDARD_ERROR_OF_MEAN|50.7|||TWO_SIDED|90.0|141.904|216.149|||||Relative bioavailability was estimated by the ratio of the gMeans of Dabigatran etexilate 150 mg (T1) divided by Dabigatran etexilate 150 mg (R). Standard Error of the mean is actually the intra individual coefficient variation (gCV).|An Analysis of variance (ANOVA) model was used on the logarithmic scale in order to compare the Test treatment vs. the Reference treatment. This model included effects for 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||216.149|141.904|
72493177|NCT02171611|144515317|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|154.84|STANDARD_ERROR_OF_MEAN|46.6|||TWO_SIDED|90.0|127.425|188.161|||||Relative bioavailability was estimated by the ratio of the geometric means (gMeans) of Dabigatran etexilate 150 mg (T2) divided by Dabigatran etexilate 150 mg (R). Standard Error of the mean is actually the intra individual gCV.|An Analysis of variance (ANOVA) model was used on the logarithmic scale in order to compare the Test treatment (T2) vs. the Reference treatment (R). This model included effects for 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||188.161|127.425|
72504417|NCT01855789|144539436|SUPERIORITY||DAS28 Remission Rate Difference|-9.5||||0.1062|TWO_SIDED|95.0|-20.9|1.8|||Cochran-Mantel-Haenszel||TCZ + PBO minus TCZ + MTX|Week 40: Analysis of association between treatment group and response, stratified by the randomization stratification factors: DAS28 remission status at Week 24 (\<2.6, \>=2.6 to \<=3.2), baseline weight-by-dosing group (\<80 kg q2w, \<80 kg qw, 80-\<100 kg q2w, 80-\<100 kg qw, \>=100 kg qw), participant anti-TNF exposure (Yes/No).||1.8|-20.9|0.1062
72504969|NCT01462292|144541156|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.831||||0.384|TWO_SIDED|95.0|-1.072|2.735||No adjustment for multiplicity was made, so p-values should not be used to make conclusions with regards to statistical significance|ANCOVA|Model included terms for treatment, centre grouping and baseline||Treatment difference: Placebo Vs GSK2402968 6 mg||2.735|-1.072|0.384
72431964|NCT01251614|144376283|SUPERIORITY_OR_OTHER||Difference|1.61||||0.304|TWO_SIDED|95.0|-1.48|4.7|||ANOVA|||Statistical comparisons for the ranked secondary endpoints were carried out in hierarchical order. All statistical tests were 2-sided with the significance level of 5%. Statistically significant results (p-value ≤ 0.05) must have been achieved for a comparison in the higher rank in order to initiate the next comparison in the lower rank.||4.70|-1.48|0.304
72431965|NCT01251614|144376284|SUPERIORITY_OR_OTHER||Difference|-8.88||||0.005|TWO_SIDED|95.0|-14.94|-2.82|||ANOVA|||Statistical comparisons for the ranked secondary endpoints were carried out in hierarchical order. All statistical tests were 2-sided with the significance level of 5%. Statistically significant results (p-value ≤ 0.05) must have been achieved for a comparison in the higher rank in order to initiate the next comparison in the lower rank.||-2.82|-14.94|0.005
72431966|NCT01251614|144376285|SUPERIORITY_OR_OTHER||Difference|-28.3||||0.113|TWO_SIDED|95.0|-60.6|4.0|||Chi-squared|||"The difference between the combined adalimumab 0.8 mg/kg + MTX groups versus the adalimumab 0.4 mg/kg group.~Statistical comparisons for the ranked secondary endpoints were carried out in hierarchical order. All statistical tests were to be 2-sided with the significance level of 5%. Statistically significant results (P value ≤ 0.05) must have been achieved for a comparison in the higher rank in order to initiate the next comparison in the lower rank."||4.0|-60.6|0.113
72431967|NCT01251614|144376286|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.45||||0.343|TWO_SIDED|95.0|0.66|3.17|||Log Rank|||Statistical comparisons for the ranked secondary endpoints were carried out in hierarchical order. All statistical tests were 2-sided with the significance level of 5%. Statistically significant results (P value ≤ 0.05) must have been achieved for a comparison in the higher rank in order to initiate the next comparison in the lower rank.||3.17|0.66|0.343
72431968|NCT01251614|144376286|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.51||||0.276|TWO_SIDED|95.0|0.71|3.21|||Log Rank|||Statistical comparisons for the ranked secondary endpoints were carried out in hierarchical order. All statistical tests were 2-sided with the significance level of 5%. Statistically significant results (P value ≤ 0.05) must have been achieved for a comparison in the higher rank in order to initiate the next comparison in the lower rank.||3.21|0.71|0.276
72431969|NCT04672460|144376306|OTHER||Ratio (Test/Reference) of Adjusted Means|105.16|||||TWO_SIDED|90.0|99.0|111.7|||Mixed Models Analysis|||Treatment A were reference; treatment B were test.||111.70|99.00|
72431970|NCT04672460|144376307|OTHER||Ratio (Test/Reference) of Adjusted Means|136.62|||||TWO_SIDED|90.0|125.05|149.27|||Mixed Models Analysis|||Treatment A were reference; treatment B were test.||149.27|125.05|
72493178|NCT02171611|144515318|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means in %|175.4|STANDARD_ERROR_OF_MEAN|51.1|||TWO_SIDED|90.0|141.924|216.772|||||Relative bioavailability was estimated by the ratio of the gMean of Dabigatran etexilate 150 mg (T1) divided by Dabigatran etexilate 150 mg (R). Standard Error of the mean is actually the intra individual gCV.|An Analysis of variance (ANOVA) model was used on the logarithmic scale in order to compare the Test treatment vs. the Reference treatment. This model included effects for 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||216.772|141.924|
72493179|NCT02171611|144515318|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means in %|158.12|STANDARD_ERROR_OF_MEAN|46.7|||TWO_SIDED|90.0|130.052|192.255|||||Relative bioavailability was estimated by the ratio of the gMean of Dabigatran etexilate 150 mg (T2) divided by Dabigatran etexilate 150 mg (R). Standard Error of the mean is actually the intra individual gCV.|An Analysis of variance (ANOVA) model was used on the logarithmic scale in order to compare the Test treatment vs. the Reference treatment. This model included effects for 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||192.255|130.052|
72493180|NCT02171611|144515319|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|186.94|STANDARD_ERROR_OF_MEAN|57.7|||TWO_SIDED|90.0|147.659|236.665|||||Relative bioavailability was estimated by the ratio of the gMean of Dabigatran etexilate 150 mg (T1) divided by Dabigatran etexilate 150 mg (R). Standard Error of the mean is actually the intra individual gCV.|An Analysis of variance (ANOVA) model was used on the logarithmic scale in order to compare the Test treatment vs. the Reference treatment. This model included effects for 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||236.665|147.659|
72431971|NCT04672460|144376308|OTHER||Ratio (Test/Reference) of Adjusted Means|87.97|||||TWO_SIDED|90.0|81.82|94.58|||Mixed Models Analysis|||Treatment B were reference; treatment C were test.||94.58|81.82|
72431972|NCT04672460|144376309|OTHER||Ratio (Test/Reference) of Adjusted Means|58.26|||||TWO_SIDED|90.0|51.55|65.84|||Mixed Models Analysis|||Treatment B were reference; treatment C were test.||65.84|51.55|
72504970|NCT01462292|144541157|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.002||||0.997|TWO_SIDED|95.0|-0.883|0.886||No adjustment for multiplicity was made, so p-values should not be used to make conclusions with regards to statistical significance|ANCOVA|Model included terms for treatment,centre grouping and baseline||Placebo (combined) Vs GSK2402968 3 mg/kg/week, Ascent Week 24||0.886|-0.883|0.997
72431973|NCT03575962|144376317|OTHER||Ratio of geometric least square mean|1.1169|||||TWO_SIDED|90.0|0.99|1.27||||||||1.27|0.99|
72431974|NCT03575962|144376318|OTHER||Ratio of geometric least square mean|1.1556|||||TWO_SIDED|90.0|0.99|1.35||||||||1.35|0.99|
72431975|NCT00961805|144376341|SUPERIORITY_OR_OTHER||||||<|0.001||||||Differences in the behavior of the groups over time.|ANOVA|||"Sample size was calculated by visual analogue scale for pain (alpha error of 5%, beta error of 20% and standard deviation of 2). The sample was determined to contain 30 patients in each group. Ten additional patients were added to compensate possible losses.~Analysis was intention to treat using the LOCF technique."||||<0.001
72431976|NCT00961805|144376342|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Differences in the behavior of the groups over time.|ANOVA|||||||<0.001
72431977|NCT00961805|144376343|SUPERIORITY_OR_OTHER||||||<|0.003||95.0||||Differences in the behavior of the groups over time.|ANOVA|||||||<0.003
72431978|NCT00961805|144376344|SUPERIORITY_OR_OTHER|||||||0.146||95.0||||Differences in the behavior of the groups over time.|ANOVA|||||||0.146
72431979|NCT00961805|144376345|SUPERIORITY_OR_OTHER|||||||0.131||95.0||||Differences in the behavior of the groups over time.|ANOVA|||||||0.131
72431980|NCT00961805|144376346|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Differences in the behavior of the groups over time.|ANOVA|||||||<0.001
72431981|NCT00961805|144376347|SUPERIORITY_OR_OTHER|||||||0.58||95.0||||Differences in the behavior of the groups over time.|ANOVA|||||||0.580
72431982|NCT00961805|144376348|SUPERIORITY_OR_OTHER|||||||0.082||95.0||||Differences in the behavior of the groups over time.|ANOVA|||||||0.082
72431983|NCT00961805|144376349|SUPERIORITY_OR_OTHER|||||||0.055||95.0||||Differences in the behavior of the groups over time.|ANOVA|||||||0.055
72493181|NCT02171611|144515319|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means in %|166.59|STANDARD_ERROR_OF_MEAN|54.3|||TWO_SIDED|90.0|133.221|208.326|||||Relative bioavailability was estimated by the ratio of the gMean of Dabigatran etexilate 150 mg (T2) divided by Dabigatran etexilate 150 mg (R). Standard Error of the mean is actually the intra individual gCV.|An Analysis of variance (ANOVA) model was used on the logarithmic scale in order to compare the Test treatment vs. the Reference treatment. This model included effects for 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||208.326|133.221|
72493182|NCT02171611|144515320|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means in %|181.6|STANDARD_ERROR_OF_MEAN|53.9|||TWO_SIDED|90.0|145.428|226.776|||||Relative bioavailability was estimated by the ratio of the gMean of Dabigatran etexilate 150 mg (T1) divided by Dabigatran etexilate 150 mg (R). Standard Error of the mean is actually the intra individual gCV.|An Analysis of variance (ANOVA) model was used on the logarithmic scale in order to compare the Test treatment vs. the Reference treatment. This model included effects for 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||226.776|145.428|
72493183|NCT02171611|144515320|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means in %|166.83|STANDARD_ERROR_OF_MEAN|52.6|||TWO_SIDED|90.0|134.25|207.328|||||Relative bioavailability was estimated by the ratio of the gMean of Dabigatran etexilate 150 mg (T2) divided by Dabigatran etexilate 150 mg (R). Standard Error of the mean is actually the intra individual geometric coefficient variation (gCV).|An Analysis of variance (ANOVA) model was used on the logarithmic scale in order to compare the Test treatment vs. the Reference treatment. This model included effects for 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||207.328|134.25|
72493184|NCT02171611|144515321|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means in %|182.17|STANDARD_ERROR_OF_MEAN|56.1|||TWO_SIDED|90.0|144.727|229.297|||||Relative bioavailability was estimated by the ratio of the gMean of Dabigatran etexilate 150 mg (T1) divided by Dabigatran etexilate 150 mg (R). Standard Error of the mean is actually the intra individual gCV.|An Analysis of variance (ANOVA) model was used on the logarithmic scale in order to compare the Test treatment vs. the Reference treatment. This model included effects for 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||229.297|144.727|
72493185|NCT02171611|144515321|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means in %|160.74|STANDARD_ERROR_OF_MEAN|52.0|||TWO_SIDED|90.0|129.633|199.306|||||Relative bioavailability was estimated by the ratio of the gMean of Dabigatran etexilate 150 mg (T2) divided by Dabigatran etexilate 150 mg (R). Standard Error of the mean is actually the intra individual gCV.|An Analysis of variance (ANOVA) model was used on the logarithmic scale in order to compare the Test treatment vs. the Reference treatment. This model included effects for 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||199.306|129.633|
72493186|NCT02171611|144515322|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means in %|182.25|STANDARD_ERROR_OF_MEAN|55.7|||TWO_SIDED|90.0|144.993|229.075|||||Relative bioavailability was estimated by the ratio of the gMean of Dabigatran etexilate 150 mg (T1) divided by Dabigatran etexilate 150 mg (R). Standard Error of the mean is actually the intra individual gCV.|An Analysis of variance (ANOVA) model was used on the logarithmic scale in order to compare the Test treatment vs. the Reference treatment. This model included effects for 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||229.075|144.993|
72493187|NCT02171611|144515322|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means in %|164.01|STANDARD_ERROR_OF_MEAN|51.7|||TWO_SIDED|90.0|132.421|203.14|||||Relative bioavailability was estimated by the ratio of the gMean of Dabigatran etexilate 150 mg (T2) divided by Dabigatran etexilate 150 mg (R). Standard Error of the mean is actually the intra individual gCV.|An Analysis of variance (ANOVA) model was used on the logarithmic scale in order to compare the Test treatment vs. the Reference treatment. This model included effects for 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||203.14|132.421|
72553948|NCT03570749|144640021|SUPERIORITY||Odds Ratio (OR)|6.03|||<|0.001|TWO_SIDED|95.0|2.91|12.51|||Regression, Logistic|||||12.51|2.91|<0.001
72553949|NCT03570749|144640023|SUPERIORITY||Mean Difference (Final Values)|-0.82|STANDARD_ERROR_OF_MEAN|0.288||0.005|TWO_SIDED|95.0|-1.38|-0.25|||ANCOVA|||||-0.25|-1.38|0.005
72431984|NCT00961805|144376350|SUPERIORITY_OR_OTHER|||||||0.003||95.0||||Differences in the behavior of the groups over time.|ANOVA|||||||0.003
72553950|NCT03570749|144640023|SUPERIORITY||Mean Difference (Final Values)|-0.54|STANDARD_ERROR_OF_MEAN|0.261||0.04|TWO_SIDED|95.0|-1.05|-0.02|||ANCOVA|||||-0.02|-1.05|0.040
72431985|NCT00961805|144376351|SUPERIORITY_OR_OTHER|||||||0.021||95.0||||Differences in the behavior of the groups over time.|ANOVA|||||||0.021
72431986|NCT00961805|144376352|SUPERIORITY_OR_OTHER|||||||0.136||95.0||||Differences in the behavior of the groups over time.|ANOVA|||||||0.136
72431987|NCT00961805|144376353|SUPERIORITY_OR_OTHER|||||||0.009||95.0||||Differences in the behavior of the groups over time.|ANOVA|||||||0.009
72431988|NCT03371108|144376361|EQUIVALENCE|The determination of equivalence was defined by the US-FDA as a confidence interval that was contained within the equivalence limits of +/- 10.7.|Risk Difference (RD)|-2.1|STANDARD_ERROR_OF_MEAN|3.39|||TWO_SIDED|90.0|-7.6|3.5|||||The asymptotic standard error was planned and is reported above.|This is a two-arm study.||3.5|-7.6|
72469417|NCT01018732|144462514|SUPERIORITY_OR_OTHER||ratio of titer|2.51|||||TWO_SIDED|95.0|1.27|4.96|||ANOVA|||Day 1, Men W-135, Pairwise comparison of geometric mean titer||4.96|1.27|
72469418|NCT01018732|144462514|SUPERIORITY_OR_OTHER||ratio of titer|2.77|||||TWO_SIDED|95.0|1.38|5.57|||ANOVA|||Day 1, Men W-135, Pairwise comparison of geometric mean titer||5.57|1.38|
72493188|NCT01967537|144515370|SUPERIORITY|||||||0.23|||||||Mann-Whitney|||||||0.23
72431989|NCT02790606|144376376|SUPERIORITY|||||||0.0021|||||||Exact binomial test|||"The primary safety endpoint is evaluated against a PG of 88%, which was derived from safety event rates of PTA in published literature.~Hypothesis: The safety rate in subjects treated with the COVERA™ Vascular Covered Stent (following PTA) at 30 days post-index procedure is greater than that of the PG of 88%. 109 treated subjects \[104 evaluable\] will give 99% power with one-sided type I error = 0.05."||||0.0021
72431990|NCT02790606|144376377|SUPERIORITY||||||<|0.0001||||||The p-value is compared to the PG (40%) and computed using the exact binomial test.|Exact binomial test|||"The primary effectiveness endpoint is evaluated against a PG of 40%, which was derived from clinical literature as well as other pivotal and post-market studies of stent grafts at the graft-vein anastomosis of AV access patients dialyzing with an AV graft. 89% estimated power for primary endpoint.~Hypothesis: The proportion of subjects treated with the COVERA™ Vascular Covered Stent (following PTA) with respect to TLPP through 6 months post-index procedure is greater than that of the PG of 40%."||||<0.0001
72431991|NCT01764386|144376420|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-8.52|||<|0.0001|TWO_SIDED|95.0|-9.88|-7.15|||ANCOVA|||||-7.15|-9.88|<0.0001
72431992|NCT01764386|144376421|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|44.0|||<|0.0001|TWO_SIDED|95.0|16.6|116.3|||Regression, Logistic|||||116.3|16.6|<0.0001
72431993|NCT01764386|144376422|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|21.4|||<|0.0001|TWO_SIDED|95.0|6.0|76.7|||Regression, Logistic|||||76.7|6.0|<0.0001
72431994|NCT01764386|144376424|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-8.65|||<|0.0001|TWO_SIDED|95.0|-10.07|-7.24|||ANCOVA|||||-7.24|-10.07|<0.0001
72431995|NCT01764386|144376425|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.32|||<|0.0001|TWO_SIDED|95.0|-7.14|-3.5|||ANCOVA|||||-3.50|-7.14|<0.0001
72431996|NCT01764386|144376426|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-16.4||||0.0019|TWO_SIDED|95.0|-29.5|-3.3|||ANCOVA|||||-3.3|-29.5|0.0019
72431997|NCT01764386|144376427|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1||||0.9686|TWO_SIDED|95.0|-5.96|5.73|||ANCOVA|||||5.73|-5.96|0.9686
72431998|NCT01764386|144376428|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.0||||0.0001|TWO_SIDED|95.0|1.99|6.06|||ANCOVA|||||6.06|1.99|0.0001
72493189|NCT05130463|144515398|OTHER|||||||0.0011||||||Comparison of the change in HbA1c from baseline to the values at 12 weeks post Esgliteo administration.|t-test, 2 sided|||||||0.0011
72431999|NCT01764386|144376429|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.0||||0.1706|TWO_SIDED|95.0|-4.9|0.9|||ANCOVA|||||0.9|-4.9|0.1706
72432000|NCT01764386|144376430|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.4||||0.716|TWO_SIDED|95.0|-2.6|1.8|||ANCOVA|||||1.8|-2.6|0.7160
72432001|NCT01764386|144376431|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.0||||0.0913|TWO_SIDED|95.0|-0.3|4.3|||ANCOVA|||||4.3|-0.3|0.0913
72432002|NCT01764386|144376432|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.5||||0.0016|TWO_SIDED|95.0|-7.2|-1.7|||ANCOVA|||||-1.7|-7.2|0.0016
72432003|NCT01764386|144376433|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.1||||0.0004|TWO_SIDED|95.0|-6.2|-2.0|||ANCOVA|||||-2.0|-6.2|0.0004
72432004|NCT01764386|144376434|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.2||||0.0003|TWO_SIDED|95.0|-1.7|-0.7|||ANCOVA|||||-0.7|-1.7|0.0003
72432005|NCT01764386|144376435|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-7.9|||<|0.0001|TWO_SIDED|95.0|-9.8|-6.0|||ANCOVA|||||-6.0|-9.8|<0.0001
72432006|NCT01764386|144376436|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.1|||<|0.0001|TWO_SIDED|95.0|-3.1|-1.1|||ANCOVA|||||-1.1|-3.1|<0.0001
72432007|NCT01764386|144376437|SUPERIORITY_OR_OTHER||Mean Difference (Net)|17.4|||<|0.0001|TWO_SIDED|95.0|13.45|21.36|||ANCOVA|||||21.36|13.45|<0.0001
72432008|NCT03929302|144376438|SUPERIORITY||Mean Difference (Final Values)|2.2||||0.05|TWO_SIDED||||||Regression, Linear|||||||0.05
72432009|NCT03929302|144376438|SUPERIORITY||Mean Difference (Final Values)|1.57||||0.2|TWO_SIDED||||||Regression, Linear|||||||0.20
72432010|NCT03929302|144376438|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.642|TWO_SIDED||||||Regression, Linear|||||||0.642
72432011|NCT01492309|144376469|SUPERIORITY|||||||0.003|||||||Fisher Exact|||This analysis is based on a mixed model that can handle missing data.||||0.003
72432012|NCT01492309|144376470|SUPERIORITY|||||||0.425|||||||Regression, Logistic|||This analysis is based on a mixed model that can handle missing data.||||0.425
72432013|NCT01360840|144376473|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.89|||||TWO_SIDED|95.0|0.57|1.39||||||||1.39|0.57|
72432014|NCT01360840|144376473|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.81|||||TWO_SIDED|95.0|0.52|1.26||||||||1.26|0.52|
72432015|NCT01360840|144376474|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.1|||||TWO_SIDED|95.0|0.52|2.31||||||||2.31|0.52|
72432016|NCT01360840|144376474|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.01|||||TWO_SIDED|95.0|0.47|2.15||||||||2.15|0.47|
72432017|NCT01360840|144376475|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.91|||||TWO_SIDED|95.0|0.58|1.44||||||||1.44|0.58|
72432018|NCT01360840|144376475|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.81|||||TWO_SIDED|95.0|0.52|1.27||||||||1.27|0.52|
72432019|NCT00293462|144376495|SUPERIORITY_OR_OTHER_LEGACY|||||||0.09||95.0|||||Fisher Exact|Two by two table was used. One cell had expected frequency test less than five, so Fisher's exact two-tailed test was used.||Fisher's exact two tailed test||||0.09
72469419|NCT01018732|144462514|SUPERIORITY_OR_OTHER||ratio of titer|0.54|||||TWO_SIDED|95.0|0.28|1.04|||ANOVA|||Day 8, Men W-135, Pairwise comparison of geometric mean titer||1.04|0.28|
72493190|NCT05130463|144515399|OTHER|||||||0.0014||||||Comparison of the change in HbA1c from baseline to the values at 24 weeks post Esgliteo administration.|t-test, 2 sided|||||||0.0014
72493191|NCT05130463|144515404|OTHER|||||||0.0008||||||Comparison of the change in FPG from baseline to the values at 12 weeks post Esgliteo administration.|t-test, 2 sided|Paired t-test: Statistically significant at a 5% two-sided level.||FPG at baseline vs FPG after 12 weeks of treatment.||||0.0008
72493192|NCT05130463|144515405|OTHER|||||||0.0068||||||Comparison of the change in FPG from baseline to the values at 24 weeks post Esgliteo administration.|t-test, 2 sided|Paired t-test: Statistically significant at a 5% two-sided level.||FPG at baseline vs FPG after 24 weeks of treatment.||||0.0068
72493193|NCT05130463|144515406|OTHER|||||||0.1867||||||Comparison of the change in body weight from baseline to the values at 12 weeks post Esgliteo administration.|t-test, 2 sided|Paired t-test: Statistically significant at a 5% two-sided level||Body weight at baseline vs Body weight after 12 weeks of treatment.||||0.1867
72432020|NCT00293462|144376496|SUPERIORITY_OR_OTHER_LEGACY|||||||0.92|TWO_SIDED|95.0|||||Mantel Haenszel|Log rank, Breslow, Tarone-Ware test, but used mantel cox log rank for this analysis||Kaplan-Meier estimate of the survival curves used information from subjects who develop mucositis to the healing of the mucositis in three groups, Group GG, SS, and SG. In order to compare the three curves that were created, the Mantel-Haenszel log-rank statistic was used||||0.92
72432021|NCT00293462|144376497|SUPERIORITY_OR_OTHER_LEGACY|||||||0.28||95.0||||0.28 (quadratic)|Mixed Models Analysis|Restricted Maximum Likelihood Methods with random intercepts was the only model used for the three groups and seven measurement time points.||Multilevel regression was used.||||0.28
72493194|NCT05130463|144515407|OTHER|||||||0.0003||||||Comparison of the change in body weight from baseline to the values at 24 weeks post Esgliteo administration.|t-test, 2 sided|Paired t-test: Statistically significant at a 5% two-sided level.||Body weight at baseline vs Body weight after 24 weeks of treatment.||||0.0003
72493195|NCT05130463|144515408|OTHER|||||||0.002||||||Comparison of the change in SBP from baseline to the values at 12 weeks post Esgliteo administration.|t-test, 2 sided|Paired t-test: Statistically significant at a 5% two-sided level.||SBP at baseline vs SBP after 12 weeks of treatment.||||0.0020
72493196|NCT05130463|144515408|OTHER|||||||0.0132||||||Comparison of the change in DBP from baseline to the values at 12 weeks post Esgliteo administration.|t-test, 2 sided|Paired t-test: Statistically significant at a 5% two-sided level.||DBP at baseline vs DBP after 12 weeks of treatment.||||0.0132
72493197|NCT05130463|144515409|OTHER|||||||0.7591||||||Comparison of the change in SBP from baseline to the values at 24 weeks post Esgliteo administration.|t-test, 2 sided|Paired t-test: Statistically significant at a 5% two-sided level.||SBP at baseline vs SBP after 24 weeks of treatment.||||0.7591
72493198|NCT05130463|144515409|OTHER|||||||0.5161||||||Comparison of the change in DBP from baseline to the values at 24 weeks post Esgliteo administration.|t-test, 2 sided|Paired t-test: Statistically significant at a 5% two-sided level.||DBP at baseline vs DBP after 24 weeks of treatment.||||0.5161
72493199|NCT03461757|144515410|SUPERIORITY||Risk Difference (RD)|10.4|||<|0.0001|TWO_SIDED|95.0|6.5|14.2|||Cochran-Mantel-Haenszel|||||14.2|6.5|< 0.0001
72493200|NCT03461757|144515411|SUPERIORITY||Risk Difference (RD)|8.3||||0.0009|TWO_SIDED|95.0|3.4|13.2|||Cochran-Mantel-Haenszel|||||13.2|3.4|0.0009
72553951|NCT03570749|144640024|SUPERIORITY||Mean Difference (Final Values)|-0.42|STANDARD_ERROR_OF_MEAN|0.259||0.107|TWO_SIDED|95.0|-0.93|0.09|||ANCOVA|||||0.09|-0.93|0.107
72614848|NCT00898807|144759847|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.13||||0.007|TWO_SIDED|95.0|1.23|3.69||All p-values are two-sided and p \<0.05 was the threshold for statistical significance. No adjustments were made for multiple comparisons.|Proportional odds|estimated treatment effect from the proportional odds model|Positive numbers favors citalopram.|Primary assessment of efficacy was based on intention-to-treat comparison of the difference in the NBRS-A scores at week 9 and comparison at week 9 for the CGIC. For the CGIC proportional odds analysis, the study was designed to have power greater than 80% to detect a difference of 20% between citalopram and placebo in the proportions of patients who improve (or worsen).||3.69|1.23|0.007
72432022|NCT00293462|144376498|SUPERIORITY_OR_OTHER_LEGACY|||||||0.78||95.0||||0.78 (quadratic)|Mixed Models Analysis|Restricted Maximum Likelihood Methods with random intercepts was the only model used for the three groups and seven measurement time points.||||||0.78
72432023|NCT00293462|144376499|SUPERIORITY_OR_OTHER_LEGACY|||||||0.22||95.0||||0.22 (quadratic)|Mixed Models Analysis|Restricted Maximum Likelihood Methods with random intercepts was the only model used for the three groups and seven measurement time points.||||||0.22
72432024|NCT01950260|144376528|SUPERIORITY|||||||0.23|||||||Fisher Exact|||||||0.23
72432025|NCT01950260|144376529|SUPERIORITY|||||||0.41|||||||Regression, Linear|||||||0.41
72432026|NCT01950260|144376530|SUPERIORITY|||||||0.33|||||||Regression, Linear|||||||0.33
72469420|NCT01018732|144462514|SUPERIORITY_OR_OTHER||ratio of titer|50.0|||||TWO_SIDED|95.0|26.0|94.0|||ANOVA|||Day 8, Men W-135, Pairwise comparison of geometric mean titer||94|26|
72493201|NCT03461757|144515412|SUPERIORITY||Risk Difference (RD)|16.1|||<|0.0001|TWO_SIDED|95.0|10.8|21.3|||Cochran-Mantel-Haenszel|||||21.3|10.8|< 0.0001
72493202|NCT03461757|144515413|SUPERIORITY||Risk Difference (RD)|20.1|||<|0.0001|TWO_SIDED|95.0|15.1|25.2|||Cochran-Mantel-Haenszel|||||25.2|15.1|< 0.0001
72493203|NCT03461757|144515414|SUPERIORITY||Risk Difference (RD)|20.1|||<|0.0001|TWO_SIDED|95.0|15.1|25.2|||Cochran-Mantel-Haenszel|||||25.2|15.1|< 0.0001
72493204|NCT03461757|144515415|SUPERIORITY||Risk Difference (RD)|9.3|||<|0.0001|TWO_SIDED|95.0|4.9|13.7|||Cochran-Mantel-Haenszel|||||13.7|4.9|< 0.0001
72493205|NCT03461757|144515416|SUPERIORITY||Risk Difference (RD)|-15.0|||<|0.0001|TWO_SIDED|95.0|-19.3|-10.7|||Cochran-Mantel-Haenszel|||||-10.7|-19.3|< 0.0001
72493206|NCT03461757|144515417|SUPERIORITY||Risk Difference (RD)|12.7|||<|0.0001|TWO_SIDED|95.0|8.3|17.2|||Cochran-Mantel-Haenszel|||||17.2|8.3|< 0.0001
72493207|NCT03461757|144515418|SUPERIORITY||Risk Difference (RD)|16.9|||<|0.0001|TWO_SIDED|95.0|12.0|21.9|||Cochran-Mantel-Haenszel|||||21.9|12.0|< 0.0001
72493208|NCT03461757|144515419|SUPERIORITY||Risk Difference (RD)|6.8||||0.0018|TWO_SIDED|95.0|2.5|11.0|||Cochran-Mantel-Haenszel|||||11.0|2.5|0.0018
72493209|NCT03461757|144515420|SUPERIORITY||Risk Difference (RD)|10.6|||<|0.0001|TWO_SIDED|95.0|6.3|14.9|||Cochran-Mantel-Haenszel|||||14.9|6.3|< 0.0001
72493210|NCT03461757|144515421|SUPERIORITY||Risk Difference (RD)|8.8||||0.0007|TWO_SIDED|95.0|3.7|13.9|||Cochran-Mantel-Haenszel|||||13.9|3.7|0.0007
72493211|NCT03461757|144515422|SUPERIORITY||Risk Difference (RD)|8.9||||0.0002|TWO_SIDED|95.0|4.3|13.6|||Cochran-Mantel-Haenszel|||||13.6|4.3|0.0002
72493212|NCT03461757|144515423|SUPERIORITY||Risk Difference (RD)|12.4|||<|0.0001|TWO_SIDED|95.0|7.1|17.6|||Cochran-Mantel-Haenszel|||||17.6|7.1|< 0.0001
72493213|NCT03461757|144515424|SUPERIORITY||Risk Difference (RD)|10.1|||<|0.0001|TWO_SIDED|95.0|6.9|13.4|||Cochran-Mantel-Haenszel|||||13.4|6.9|< 0.0001
72493214|NCT03461757|144515425|SUPERIORITY||Risk Difference (RD)|5.8||||0.0128|TWO_SIDED|95.0|1.2|10.4|||Cochran-Mantel-Haenszel|||||10.4|1.2|0.0128
72493215|NCT03461757|144515426|SUPERIORITY||Risk Difference (RD)|7.8|||<|0.0001|TWO_SIDED|95.0|4.4|11.1|||Cochran-Mantel-Haenszel|||||11.1|4.4|< 0.0001
72493216|NCT03461757|144515427|SUPERIORITY||Risk Difference (RD)|11.5||||0.0003|TWO_SIDED|95.0|5.3|17.7|||Cochran-Mantel-Haenszel|||||17.7|5.3|0.0003
72553952|NCT03570749|144640024|SUPERIORITY||Mean Difference (Final Values)|-0.32|STANDARD_ERROR_OF_MEAN|0.234||0.174|TWO_SIDED|95.0|-0.78|0.14|||ANCOVA|||||0.14|-0.78|0.174
72493217|NCT03461757|144515428|SUPERIORITY||Risk Difference (RD)|8.0|||<|0.0001|TWO_SIDED|95.0|4.9|11.1|||Cochran-Mantel-Haenszel|||||11.1|4.9|< 0.0001
72493218|NCT03461757|144515429|SUPERIORITY||Risk Difference (RD)|5.5||||0.0314|TWO_SIDED|95.0|0.5|10.6|||Cochran-Mantel-Haenszel|||||10.6|0.5|0.0314
72493219|NCT03461757|144515430|SUPERIORITY||Risk Difference (RD)|6.4||||0.0025|TWO_SIDED|95.0|2.3|10.6|||Cochran-Mantel-Haenszel|||||10.6|2.3|0.0025
72432027|NCT03283553|144376531|SUPERIORITY|||||||0.264||||||P-value represents interaction for differential changes between time point (9 months compared to baseline) and group assignment.|Regression, Logistic|Adjusts for baseline patient education, care partner gender, and patient disease stage.||Complete illness understanding at 9 months was compared to baseline using logistic regression models estimated with generalized estimating equations (GEE) and an exchangeable correlation specification. Each model included group assignment, time (9 months versus baseline), their interaction, and covariates.||||0.264
72432028|NCT03283553|144376532|SUPERIORITY|||||||0.555||||||P-value represents the significance of the term for group assignment.|Regression, Linear|Adjusts for baseline patient education, care partner gender, and patient disease stage.||Satisfaction with cancer care at 9 months was compared to baseline using linear regression models with the difference in the score as the outcome and a term for group assignment as the main independent variable.||||0.555
72432029|NCT03283553|144376533|SUPERIORITY|||||||0.619||||||P-value represents interaction for differential changes between time point (9 months vs baseline) and group assignment.|Regression, Logistic|Adjusts for baseline patient education, care partner gender, and patient disease stage.||Symptoms of anxiety at 9 months were compared to baseline using logistic regression models estimated with generalized estimating equations (GEE) and an exchangeable correlation specification. Each model included group assignment, time (9 months versus baseline), their interaction, and covariates.||||0.619
72493220|NCT03461757|144515431|SUPERIORITY||Risk Difference (RD)|5.9||||0.0898|TWO_SIDED|95.0|-0.9|12.7||P-Value ≥ 0.05; therefore, all secondary endpoints listed after this endpoint in the hierarchy were not tested.|Cochran-Mantel-Haenszel|||||12.7|-0.9|0.0898
72432030|NCT03283553|144376534|SUPERIORITY|||||||0.532||||||P-value represents interaction for differential changes between time point (9 months compared to baseline) and group assignment.|Regression, Logistic|Adjusts for baseline patient education, care partner gender, and patient disease stage.||Complete illness understanding at 9 months was compared to baseline using logistic regression models estimated with generalized estimating equations (GEE) and an exchangeable correlation specification. Each model included group assignment, time (9 months versus baseline), their interaction, and covariates.||||0.532
72493221|NCT02508194|144515456|SUPERIORITY||Vaccine efficacy|-7.1|||||TWO_SIDED|90.0|-106.9|44.3|||||The CI was estimated by an exact conditional method.|2 sided 90 percent (%) confidence interval (CI) was used to compare vaccine efficacy (VE). VE = (\[1 - relative risk (RR)\] \*100%), where RR was the RR of ARA-RI in the MEDI7510 group compared with the placebo group. A lower bound of the 90% CI greater than (\>) 0% would demonstrate the efficacy of MEDI7510.||44.3|-106.9|
72432031|NCT03283553|144376535|SUPERIORITY|||||||0.108||||||P-value represents the significance of the term for group assignment.|Regression, Linear|Adjusts for baseline patient education, care partner gender, and patient disease stage.||Satisfaction with cancer care at 9 months was compared to baseline using linear regression models with the difference in the score as the outcome and a term for group assignment as the main independent variable.||||0.108
72432032|NCT03283553|144376536|SUPERIORITY|||||||0.405||||||P-value represents interaction for differential changes between time point (9 months vs baseline) and group assignment.|Regression, Logistic|Adjusts for baseline patient education, care partner gender, and patient disease stage.||Symptoms of anxiety at 9 months were compared to baseline using logistic regression models estimated with generalized estimating equations (GEE) and an exchangeable correlation specification. Each model included group assignment, time (9 months versus baseline), their interaction, and covariates.||||0.405
72432033|NCT03283553|144376537|SUPERIORITY|||||||0.412||||||P-value represents the significance of the term for group assignment.|Regression, Linear|Adjusts for baseline patient education, care partner gender, and patient disease stage.||Quality of communication at 9 months was compared to baseline using linear regression models with the difference in the score as the outcome and a term for group assignment as the main independent variable.||||0.412
72493222|NCT05110300|144515513|SUPERIORITY|||||||0.0283||||||The a priori threshold for statistical significance was p\<0.05. The p-value reported above was the calculated and resultant P-value for this analysis.|ANOVA|2-Way ANOVA with Fisher's LSD correction for multiple comparisons.||To evaluate if there were differences between pre- and post-intervention data, a 2-way analysis of variance (ANOVA) was utilized, with mixed-effects analysis being utilized when data was missing.||||0.0283
72493223|NCT05110300|144515514|SUPERIORITY|||||||0.3118||||||The a priori threshold for statistical significance was p\<0.05. The p-value reported above was the calculated and resultant P-value for this analysis.|ANOVA|2-Way ANOVA with Fisher's LSD correction for multiple comparisons.||To evaluate if there were differences between pre- and post-intervention data, a 2-way analysis of variance (ANOVA) was utilized, with mixed-effects analysis being utilized when data was missing.||||0.3118
72493224|NCT05110300|144515515|SUPERIORITY|||||||0.213||||||The a priori threshold for statistical significance was p\<0.05.|t-test, 2 sided|||To evaluate differences in average outcome measure score change from baseline to last study session, a 2-sided t-test was used, with non-parametric analysis used as necessary.||||0.213
72493225|NCT05110300|144515515|EQUIVALENCE|MDC of the inpatient stroke population for the BBS was used as the equivalence bounds. Equivalence bounds were set at +/- 6.9|||||<|0.001||||||The a priori threshold for statistical significance was p\<0.05.|t-test, 2 sided|||||||<0.001
72493226|NCT05110300|144515515|SUPERIORITY|||||||0.32||||||The a priori threshold for statistical significance was p\<0.05. The p-value reported above was the calculated and resultant P-value for this analysis.|ANCOVA|ANCOVA, with the number of sessions completed as the covariate.||Because each participant may have had a different number of BWSS sessions completed, an ANCOVA was used to assess for mean differences in outcome score change while controlling for the number of BWSS sessions completed||||0.320
72504971|NCT01462292|144541157|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.803||||0.064|TWO_SIDED|95.0|-1.655|0.048||No adjustment for multiplicity was made, so p-values should not be used to make conclusions with regards to statistical significance|ANCOVA|Model included terms for treatment, centre grouping and baseline||Placebo (combined) Vs GSK2402968 6 mg/kg/week, Ascent, Week 24||0.048|-1.655|0.064
72493227|NCT05110300|144515516|SUPERIORITY|||||||0.2612||||||The a priori threshold for statistical significance was p\<0.05. The p-value reported above was the calculated and resultant P-value for this analysis.|Mixed Models Analysis|Because some values are missing, these data were analyzed by fitting a mixed model, rather than by repeated measures ANOVA.||To evaluate if there were differences between pre- and post-intervention data, a 2-way analysis of variance (ANOVA) was utilized, with mixed-effects analysis being utilized when data was missing.||||0.2612
72493228|NCT05110300|144515517|SUPERIORITY|||||||0.541||||||The a priori threshold for statistical significance was p\<0.05. The p-value reported above was the calculated and resultant P-value for this analysis.|Mixed Models Analysis|Because some values are missing, these data were analyzed by fitting a mixed model, rather than by repeated measures ANOVA.||To evaluate if there were differences between pre- and post-intervention data, a 2-way analysis of variance (ANOVA) was utilized, with mixed-effects analysis being utilized when data was missing.||||0.5410
72371118|NCT02695420|144252540|SUPERIORITY||Treatment Difference|25.5|STANDARD_ERROR_OF_MEAN|6.5||0.0002|TWO_SIDED|95.0|12.6|38.4|||Repeated measures model|||||38.4|12.6|0.0002
72371119|NCT00916929|144252601|SUPERIORITY_OR_OTHER||rate per patient year of follow up|1.5||||||95.0|||||exact method|95% Upper Confidence Limit of objective performance criteria||"For each patient cohort, the hypothesis is formally expressed as follows:~H0: Expected False Positive Rate ≥1.5 per patient-year of follow-up Ha: Expected False Positive Rate \<1.5 per patient-year of follow-up~The null hypothesis is rejected at the 5% significance level if the 95% upper confidence limit (UCL) for expected FPR is less than 1.5 per patient-year of follow-up."||||
72493229|NCT05110300|144515518|SUPERIORITY|||||||0.6282||||||The a priori threshold for statistical significance was p\<0.05.|Wilcoxon (Mann-Whitney)|||To evaluate differences in average outcome measure score change from baseline to last study session, a 2-sided t-test was used, with non-parametric analysis used as necessary.||||0.6282
72493230|NCT05110300|144515518|SUPERIORITY|||||||0.5056||||||The a priori threshold for statistical significance was p\<0.05. The p-value reported above was the calculated and resultant P-value for this analysis.|ANCOVA|ANCOVA, with the number of sessions completed as the covariate.||Because each participant may have had a different number of BWSS sessions completed, an ANCOVA was used to assess for mean differences in outcome score change while controlling for the number of BWSS sessions completed||||0.5056
72493231|NCT05110300|144515519|SUPERIORITY|||||||0.558||||||The a priori threshold for statistical significance was p\<0.05. The p-value reported above was the calculated and resultant P-value for this analysis.|Mixed Models Analysis|Because some values are missing, these data were analyzed by fitting a mixed model, rather than by repeated measures ANOVA.||To evaluate if there were differences between pre- and post-intervention data, a 2-way analysis of variance (ANOVA) was utilized, with mixed-effects analysis being utilized when data was missing.||||0.5580
72493232|NCT05110300|144515520|SUPERIORITY|||||||0.0897||||||The a priori threshold for statistical significance was p\<0.05. The p-value reported above was the calculated and resultant P-value for this analysis.|Mixed Models Analysis|Because some values are missing, these data were analyzed by fitting a mixed model, rather than by repeated measures ANOVA.||To evaluate if there were differences between pre- and post-intervention data, a 2-way analysis of variance (ANOVA) was utilized, with mixed-effects analysis being utilized when data was missing.||||0.0897
72493233|NCT05110300|144515521|SUPERIORITY|||||||0.0549||||||The a priori threshold for statistical significance was p\<0.05.|t-test, 2 sided|||To evaluate differences in average outcome measure score change from baseline to last study session, a 2-sided t-test was used, with non-parametric analysis used as necessary.||||0.0549
72493234|NCT05110300|144515521|SUPERIORITY|||||||0.05626||||||The a priori threshold for statistical significance was p\<0.05. The p-value reported above was the calculated and resultant P-value for this analysis.|ANCOVA|ANCOVA, with the number of sessions completed as the covariate.||Because each participant may have had a different number of BWSS sessions completed, an ANCOVA was used to assess for mean differences in outcome score change while controlling for the number of BWSS sessions completed||||0.05626
72493235|NCT05110300|144515522|SUPERIORITY|||||||0.0706||||||The a priori threshold for statistical significance was p\<0.05. The p-value reported above was the calculated and resultant P-value for this analysis.|ANOVA|2-Way ANOVA with Fisher's LSD correction for multiple comparisons.||To evaluate if there were differences between pre- and post-intervention data, a 2-way analysis of variance (ANOVA) was utilized, with mixed-effects analysis being utilized when data was missing.||||0.0706
72493236|NCT05110300|144515523|SUPERIORITY|||||||0.1629||||||The a priori threshold for statistical significance was p\<0.05. The p-value reported above was the calculated and resultant P-value for this analysis.|ANOVA|2-Way ANOVA with Fisher's LSD correction for multiple comparisons.||To evaluate if there were differences between pre- and post-intervention data, a 2-way analysis of variance (ANOVA) was utilized, with mixed-effects analysis being utilized when data was missing.||||0.1629
72493237|NCT05110300|144515524|SUPERIORITY|||||||0.4271||||||The a priori threshold for statistical significance was p\<0.05.|t-test, 2 sided|||To evaluate differences in average outcome measure score change from baseline to last study session, a 2-sided t-test was used, with non-parametric analysis used as necessary.||||0.4271
72371120|NCT00916929|144252602|SUPERIORITY_OR_OTHER||sensitivity|50.0|STANDARD_ERROR_OF_MEAN|5.0|||ONE_SIDED|95.0|50.0||||exact method|||"For each patient cohort, the hypothesis is formally expressed as follows:~H0: Sensitivity ≤ 50% Ha: Sensitivity \> 50%~The desired outcome was to reject the null hypothesis at the 5% significance level. The null hypothesis is rejected at the 5% significance level if the 95% lower confidence limit (LCL) for sensitivity is greater than 50%."|||50|
72614849|NCT02493855|144759857|SUPERIORITY|This study was an exploratory study to evaluate the effect of ribavirin on the slope of the second phase of HCV RNA decline in participants who received the 3-direct-acting antiviral agent regimen.||||||0.311|||||||Wilcoxon Rank Sum Test|||||||0.311
72371121|NCT01640834|144252644|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.84||||0.0542|TWO_SIDED|95.0|-11.82|0.14|||t-test, 1 sided|||The mean change on Day 2 from Day 1 in the 24-hour insulin dose for the placebo group was subtracted from each participant's change on Day 2 from Day 1 in the 24-hour insulin dose. This placebo adjusted 24-hour insulin dose was compared within the 100-mg LY2409021 dose group using a 1 sample t-test.||0.14|-11.82|0.0542
72469421|NCT01018732|144462514|SUPERIORITY_OR_OTHER||ratio of titer|27.0|||||TWO_SIDED|95.0|14.0|52.0|||ANOVA|||Day 8, Men W-135, Pairwise comparison of geometric mean titer||52|14|
72371122|NCT01640834|144252644|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-6.89||||0.0826|TWO_SIDED|95.0|-14.95|1.16|||t-test, 1 sided|||The mean change on Day 2 from Day 1 in the 24-hour insulin dose for the placebo group was subtracted from each participant's change on Day 2 from Day 1 in the 24-hour insulin dose. This placebo adjusted 24-hour insulin dose was compared within the 300-mg LY2409021 dose group.||1.16|-14.95|0.0826
72371123|NCT01640834|144252645|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-17.0||||0.046|TWO_SIDED|95.0|-33.7|-0.4|||t-test, 1 sided|||Analysis was performed using the percent change in insulin dose, which takes into account absolute differences in individual insulin doses. The mean percent change on Day 2 from Day 1 in the 24-hour insulin dose for the placebo group was subtracted from each participant's percent change on Day 2 from Day 1 in the 24-hour insulin dose. This placebo adjusted 24-hour insulin dose was compared within the 100-mg LY2409021 dose group using a 1 sample t-test.||-0.4|-33.7|0.0460
72371124|NCT01640834|144252645|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-19.6||||0.0192|TWO_SIDED|95.0|-35.0|-4.3|||t-test, 1 sided|||Analysis was performed using the percent change in insulin dose, which takes into account absolute differences in individual insulin doses. The mean percent change on Day 2 from Day 1 in the 24-hour insulin dose for the placebo group was subtracted from each participant's percent change on Day 2 from Day 1 in the 24-hour insulin dose. This placebo adjusted 24-hour insulin dose was compared within the 300-mg LY2409021 dose group using a 1 sample t-test.||-4.3|-35.0|0.0192
72493238|NCT05110300|144515524|SUPERIORITY|||||||0.419||||||The a priori threshold for statistical significance was p\<0.05. The p-value reported above was the calculated and resultant P-value for this analysis.|ANCOVA|ANCOVA, with the number of sessions completed as the covariate.||Because each participant may have had a different number of BWSS sessions completed, an ANCOVA was used to assess for mean differences in outcome score change while controlling for the number of BWSS sessions completed||||0.4190
72493239|NCT05110300|144515525|SUPERIORITY|||||||0.3444||||||The a priori threshold for statistical significance was p\<0.05. The p-value reported above was the calculated and resultant P-value for this analysis.|ANOVA|2-Way ANOVA with Fisher's LSD correction for multiple comparisons.||To evaluate if there were differences between pre- and post-intervention data, a 2-way analysis of variance (ANOVA) was utilized, with mixed-effects analysis being utilized when data was missing.||||0.3444
72493240|NCT05110300|144515526|SUPERIORITY|||||||0.3581||||||The a priori threshold for statistical significance was p\<0.05. The p-value reported above was the calculated and resultant P-value for this analysis.|ANOVA|2-Way ANOVA with Fisher's LSD correction for multiple comparisons.||To evaluate if there were differences between pre- and post-intervention data, a 2-way analysis of variance (ANOVA) was utilized, with mixed-effects analysis being utilized when data was missing.||||0.3581
72493241|NCT05110300|144515527|SUPERIORITY|||||||0.906||||||The a priori threshold for statistical significance was p\<0.05.|t-test, 2 sided|||To evaluate differences in average outcome measure score change from baseline to last study session, a 2-sided t-test was used, with non-parametric analysis used as necessary.||||0.9060
72493242|NCT05110300|144515527|SUPERIORITY|||||||0.0848||||||The a priori threshold for statistical significance was p\<0.05. The p-value reported above was the calculated and resultant P-value for this analysis.|ANCOVA|ANCOVA, with the number of sessions completed as the covariate.||Because each participant may have had a different number of BWSS sessions completed, an ANCOVA was used to assess for mean differences in outcome score change while controlling for the number of BWSS sessions completed||||0.0848
72493243|NCT02787850|144515528|OTHER||sucess proportion|86.8|||||TWO_SIDED|95.0|71.9|95.6||||||||95.6|71.9|
72493244|NCT02787850|144515528|OTHER||success proportion|76.7|||||TWO_SIDED|95.0|57.7|90.1||||||||90.1|57.7|
72493245|NCT02787850|144515528|OTHER||success proportion|87.7|||||TWO_SIDED|95.0|76.3|94.9||||||||94.9|76.3|
72493246|NCT02787850|144515528|OTHER||success proportion|85.2|||||TWO_SIDED|95.0|66.3|95.8||||||||95.8|66.3|
72493247|NCT02921971|144515537|SUPERIORITY||Least square (LS) Mean difference|-2.31|STANDARD_ERROR_OF_MEAN|1.21||0.0291|TWO_SIDED|95.0|-4.71|0.08||Above p-value is one-sided p-value. Threshold for significance is at 0.05 level.|Mixed-effect model with repeated measure|||Analysis was performed using mixed model repeated measures (MMRM) model. The model included fixed categorical effects of treatment group, randomization strata as per IVRS, timepoint, treatment-by-timepoint and strata-by-timepoint interactions, as well as the continuous fixed covariate of baseline and baseline-by-timepoint interactions.||0.08|-4.71|0.0291
72371125|NCT01640834|144252650|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-46.0||||0.0187|TWO_SIDED|95.0|-82.0|-9.0|||t-test, 2 sided|||Statistical analysis of the effect of LY2409021 treatment on peak glucose concentration after an intramuscular injection of glucagon (1 milligram).||-9|-82|0.0187
72371126|NCT01640834|144252650|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-59.0||||0.0048|TWO_SIDED|95.0|-96.0|-23.0|||t-test, 2 sided|||Statistical analysis of the effect of LY2409021 treatment on peak glucose concentration after an intramuscular injection of glucagon (1 milligram).||-23|-96|0.0048
72371127|NCT01640834|144252651|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4423.0||||0.0278|TWO_SIDED|95.0|-8256.0|-590.0|||t-test, 2 sided|||Statistical analysis of the effect of LY2409021 treatment on area under the glucose concentration curve from time 0 to 2 hours postdose following an intramuscular injection of glucagon (1 milligram).||-590|-8256|0.0278
72371128|NCT01640834|144252651|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5187.0||||0.0046|TWO_SIDED|95.0|-8371.0|-2004.0|||t-test, 2 sided|||Statistical analysis of the effect of LY2409021 treatment on area under the glucose concentration curve from time 0 to 2 hours postdose following an intramuscular injection of glucagon (1 milligram).||-2004|-8371|0.0046
72371129|NCT01742286|144252652|OTHER||MTD/RDE|510.0||||||||||||||||||
72371130|NCT01742286|144252652|OTHER||MTD/RDE|500.0||||||||||||||||||
72493248|NCT02322710|144515541|NON_INFERIORITY|Non-inferiority was demonstrated if the upper limit of the 95% confidence interval of the observed difference between healing rates at D21 (Urgotul® - Tullegras M.S.®) in the PP population did not exceed +10%.|Difference in Percentages|1.2|STANDARD_DEVIATION|4.5|||ONE_SIDED|97.5||10.0||||||||10.0||
72504972|NCT01462292|144541157|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.685||||0.311|TWO_SIDED|95.0|-2.033|0.662||No adjustment for multiplicity was made, so p-values should not be used to make conclusions with regards to statistical significance|ANCOVA|Model included terms for treatment, centre grouping and baseline||Placebo (combined) Vs GSK2402968 3 mg/kg/week, Descent Week 24||0.662|-2.033|0.311
72493249|NCT04316585|144515558|SUPERIORITY||Mean Difference (Final Values)|-2.28|||||TWO_SIDED|95.0|-9.19|8.28|||Bayesian Logistic Regression Model|The model was adjusted for treatment (GSK2982772 vs placebo), baseline PASI score and prior biologic use (yes/no).|Posterior median and 95% CrI for the true difference in proportion of responders (GSK2982772 - placebo).|Bayesian logistic regression. An informative prior was used for the placebo response in this statistical analysis, the prior for placebo response rate was of the form: 90% weight on Be (5.39, 69) and 10% on Be (1/3,1/3). The prior was derived from historical data from similar clinical trials using meta-analytic predictive prior (MAP) approach. All other parameters took vague priors.||8.28|-9.19|
72493250|NCT04316585|144515558|SUPERIORITY||Mean Difference (Final Values)|0.11|||||TWO_SIDED|95.0|-4.81|8.07|||Bayesian Logistic Regression Model|The model was adjusted for treatment (GSK2982772 vs placebo), baseline PASI score and prior biologic use (yes/no).|Posterior median and 95% CrI for the true difference in proportion of responders (GSK2982772 - placebo).|||8.07|-4.81|
72493251|NCT00130832|144515570|NON_INFERIORITY_OR_EQUIVALENCE|non-inferiority criterion is that the lower limit of the 2-sided 95% confidence interval of the proportion difference (concomitant group minus staggered group) for subjects who achieve neutralizing antibody titers \[NA\] ≥1:8 greater than -10%.|Seroprotection Rate Difference|-0.5|||<|0.001||95.0|-2.2|1.4|||Miettinen and Nurminen's|Comparing seroprotection rate difference with the non-inferiority margin of 0.10 with Miettinen and Nurminen's method.||Seroprotection rate (proportion of subjects who achieve the seroprotection criteria: neutralizing antibody titers \[NA\] ≥1:8) for poliovirus type 1||1.4|-2.2|<0.001
72493252|NCT00130832|144515570|NON_INFERIORITY_OR_EQUIVALENCE|non-inferiority criterion is that the lower limit of the 2-sided 95% confidence interval of the proportion difference (concomitant group minus staggered group) for subjects who achieve neutralizing antibody titers \[NA\] ≥1:8 greater than -10%.|Seroprotection Rate Difference|0.0|||<|0.001||95.0|-1.4|1.6|||Miettinen and Nurminen's|Comparing seroprotection rate difference with the non-inferiority margin of 0.10 with Miettinen and Nurminen's method.||Seroprotection rate (proportion of subjects who achieve the seroprotection criteria: neutralizing antibody titers \[NA\] ≥1:8) for poliovirus type 2||1.6|-1.4|<0.001
72493253|NCT00130832|144515570|NON_INFERIORITY_OR_EQUIVALENCE|non-inferiority criterion is that the lower limit of the 2-sided 95% confidence interval of the proportion difference (concomitant group minus staggered group) for subjects who achieve neutralizing antibody titers \[NA\] ≥1:8 greater than -10%.|Seroprotection Rate Difference|-0.1|||<|0.001||95.0|-2.3|2.3|||Miettinen and Nurminen's|Comparing seroprotection rate difference with the non-inferiority margin of 0.10 with Miettinen and Nurminen's method.||Seroprotection rate (proportion of subjects who achieve the seroprotection criteria: neutralizing antibody titers \[NA\] ≥1:8) for poliovirus type 3||2.3|-2.3|<0.001
72371131|NCT04530136|144252668|SUPERIORITY|||||||0.0346|||||||Wilcoxon rank test|||||||0.0346
72493254|NCT00130832|144515571|NON_INFERIORITY_OR_EQUIVALENCE|non-inferiority criterion is that the lower limit of the 2-sided 95% confidence interval of the GMT ratio (concomitant group over staggered group) greater than 0.50.|GMT Ratio|0.54||||0.277||95.0|0.42|0.69|||ANOVA|ANOVA model on log titer of serum anti-rotavirus IgA||||0.69|0.42|0.277
72493255|NCT00130832|144515571|NON_INFERIORITY_OR_EQUIVALENCE|non-inferiority criterion is that the lower limit of the 2-sided 95% confidence interval of the proportion difference (concomitant group minus staggered group) for subjects who achieve 3-fold rise in serum anti-rotavirus IgA greater than -10%.|Percentage Point Difference|-4.4||||0.002||95.0|-8.0|-1.4|||Miettinen and Nurminen's|Comparing percentage difference with the non-inferiority margin of 10 percentage point with Miettinen and Nurminen's method.|Percentage point difference (concomitant - staggered)|||-1.4|-8.0|0.002
72493256|NCT02944448|144515578|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.7093|TWO_SIDED|95.0|-0.4|0.5|||Mixed Models Analysis|||||0.5|-0.4|0.7093
72493257|NCT02944448|144515579|SUPERIORITY||Mean Difference (Final Values)|-2.8||||0.6007|TWO_SIDED|95.0|-13.1|7.6|||Mixed Models Analysis|||||7.6|-13.1|0.6007
72493258|NCT02944448|144515580|SUPERIORITY||Median Difference (Final Values)|-0.8||||0.4563|TWO_SIDED|95.0|-3.0|1.4|||Mixed Models Analysis|||||1.4|-3.0|0.4563
72493259|NCT02944448|144515581|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.8693|TWO_SIDED|95.0|-1.0|0.8|||Mixed Models Analysis|||||0.8|-1.0|0.8693
72493260|NCT02944448|144515582|SUPERIORITY||Mean Difference (Final Values)|-1.7||||0.6516|TWO_SIDED|95.0|-9.1|5.7|||Mixed Models Analysis|||||5.7|-9.1|0.6516
72493261|NCT02944448|144515583|SUPERIORITY||Odds Ratio (OR)|0.7||||0.1033|TWO_SIDED|95.0|0.5|1.1|||Regression, Logistic|Logistic regression, including treatment, baseline weekly pain score, and OA joint as independent variables.|Ratio between treatment odds of achieving a treatment response.|||1.1|0.5|0.1033
72371132|NCT04530136|144252669|SUPERIORITY|||||||0.4441|||||||WHO Ordinal Scale|||||||0.4441
72493262|NCT02944448|144515584|SUPERIORITY||Odds Ratio (OR)|0.8||||0.2831|TWO_SIDED|95.0|0.5|1.2|||Regression, Logistic|Logistic regression, including treatment, baseline weekly pain score, and OA joint as independent variables.|Ratio between treatment odds of achieving a treatment response.|||1.2|0.5|0.2831
72493263|NCT02944448|144515585|SUPERIORITY||Odds Ratio (OR)|1.3||||0.1959|TWO_SIDED|95.0|0.9|2.0|||Regression, Logistic|Logistic regression with treatment as a main effect and OA joint as a covariate.|"Ratio between treatment odds of having a PGIC of Very Much Improved or Much Improved."|||2.0|0.9|0.1959
72493264|NCT02944448|144515586|SUPERIORITY|||||||0.2858|||||||Wilcoxon (Mann-Whitney)|Wilcoxon Rank Sum test stratified by Primary OA joint (Hip or Knee) and Baseline Week Mean of the Daily NRS (\<6.7 or \>=6.7) (Van Elteren test).||||||0.2858
72493265|NCT02944448|144515587|SUPERIORITY||Odds Ratio (OR)|0.9||||0.8002|TWO_SIDED|95.0|0.3|2.7|||Regression, Logistic|Logistic regression, including treatment, baseline pain score, and OA joint as independent variables.|Ratio between treatment odds of withdrawing from treatment due to lack of analgesic efficacy.|||2.7|0.3|0.8002
72371133|NCT04530136|144252670|SUPERIORITY|||||||0.1021|||||||WHO Ordinal Scale for Clin Improvement|||||||0.1021
72371134|NCT04530136|144252671|SUPERIORITY|||||||0.1615|||||||WHO Ordinal Scale|||||||0.1615
72371135|NCT01309282|144252672|SUPERIORITY_OR_OTHER|||||||0.0078|TWO_SIDED||||||Wilcoxon signed rank test|||||||0.0078
72371136|NCT01309282|144252673|SUPERIORITY_OR_OTHER|||||||0.0078|TWO_SIDED||||||Wilcoxon signed rank test|||||||0.0078
72371137|NCT01309282|144252674|SUPERIORITY_OR_OTHER|||||||0.01403|TWO_SIDED||||||Wilcoxon signed rank test|||||||0.01403
72371138|NCT01309282|144252675|SUPERIORITY_OR_OTHER|||||||0.0355|TWO_SIDED||||||Wilcoxon signed rank test|||||||0.0355
72371139|NCT01309282|144252676|SUPERIORITY_OR_OTHER|||||||0.5469|TWO_SIDED||||||Wilcoxon signed rank test|||||||0.5469
72493266|NCT04681170|144515612|OTHER||Mean Difference (Net)|-53.91|||<|0.0001|TWO_SIDED|95.0|-61.859|-45.9612|||t-test, 1 sided|||This was a single-arm study, no comparative group can be assigned; the comparison made for the primary efficacy endpoint is done only between baseline and Week 24 in paediatric subjects (5 to ≤17 years of age). Analysis was made using the one-sample t-test to test the null hypothesis that the percentage change from Baseline was equal to zero against the alternative hypothesis that the percentage change from Baseline was not equal to zero.||-45.9612|-61.8590|<0.0001
72493267|NCT02118792|144515635|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Regression, Logistic|||||||<0.001
72493268|NCT03118297|144515690|SUPERIORITY|||||||0.002||||||Threshold for significance: p=0.05|Wilcoxon (Mann-Whitney)|||||||0.002
72493269|NCT03118297|144515691|SUPERIORITY|||||||0.032||||||Threshold for significance: p=0.05|Fisher Exact|||||||0.032
72493270|NCT03118297|144515692|SUPERIORITY||||||<|0.001||||||Threshold for significance: p=0.05|Fisher Exact|||||||<0.001
72493271|NCT03118297|144515693|SUPERIORITY||||||>|0.05||||||Threshold for significance: p=0.05|Chi-squared|||||||>0.05
72493272|NCT03118297|144515694|OTHER|No statistical test performed|||||||||||||||||Significance testing not performed. All values below prespecified limit of 5.0 ng/mL.|||
72493273|NCT03066102|144515735|OTHER|||||||0.227||||||The level of statistical significance was set at P \< 0.05.|ANOVA|||The effects of muscle fatigue on reposition error of scapular elevation. Muscle fatigue would increase reposition error during scapular elevation. One-way repeated measures analysis of variance.||||0.227
72493274|NCT03066102|144515735|OTHER|||||||0.764||||||The level of statistical significance was set at P \< 0.05.|ANOVA|||The effects of muscle fatigue on reposition error of scapular protraction. Muscle fatigue would increase reposition error during scapular protraction. One-way repeated measures analysis of variance.||||0.764
72553953|NCT01935934|144640065|OTHER||||||||||||||||||"Trial design discriminated between co-primary endpoints of objective RR of 30% (vs 10%) and 12-week PFS of 55% (vs 30%). The design had 86% power to detect a true objective RR of at least 30% and at least 90% power to detect a true 12-week PFS rate of atleast 55% (or a median PFS of 3.4 months).~The parallel exploratory cohort of uncommon histology cancers was analyzed independently."|||
72614850|NCT02493855|144759857|SUPERIORITY|This study was an exploratory study to evaluate the effect of ribavirin on the slope of the second phase of HCV RNA decline in participants who received the 3-direct-acting antiviral agent regimen.||||||0.561|||||||Wilcoxon Rank Sum Test|||||||0.561
72493275|NCT03066102|144515736|OTHER|||||||0.413||||||The level of statistical significance was set at P \< 0.05.|ANOVA|||"The effects of muscle fatigue on muscle activation of upper trapezius during scapular elevation.~Muscle fatigue would change muscle activation during proprioception task. One-way repeated measures analysis of variance."||||0.413
72493276|NCT03066102|144515736|OTHER|||||||0.984||||||The level of statistical significance was set at P \< 0.05.|ANOVA|||"The effects of muscle fatigue on muscle activation of lower trapezius during scapular elevation.~Muscle fatigue would change muscle activation during proprioception task. One-way repeated measures analysis of variance."||||0.984
72493277|NCT03066102|144515736|OTHER|||||||0.006||||||The level of statistical significance was set at P \< 0.05.|ANOVA|||"The effects of muscle fatigue on muscle activation of serratus anterior during scapular elevation.~Muscle fatigue would change muscle activation during proprioception task. One-way repeated measures analysis of variance."||||0.006
72493278|NCT03066102|144515736|OTHER|||||||0.154||||||The level of statistical significance was set at P \< 0.05.|ANOVA|||"The effects of muscle fatigue on muscle activation of upper trapezius during scapular protraction.~Muscle fatigue would change muscle activation during proprioception task. One-way repeated measures analysis of variance."||||0.154
72493279|NCT03066102|144515736|OTHER|||||||0.096||||||The level of statistical significance was set at P \< 0.05.|ANOVA|||"The effects of muscle fatigue on muscle activation of lower trapezius during scapular protraction.~Muscle fatigue would change muscle activation during proprioception task. One-way repeated measures analysis of variance."||||0.096
72493280|NCT03066102|144515736|OTHER|||||||0.037||||||The level of statistical significance was set at P \< 0.05.|ANOVA|||"The effects of muscle fatigue on muscle activation of serratus anterior during scapular protraction.~Muscle fatigue would change muscle activation during proprioception task. One-way repeated measures analysis of variance."||||0.037
72493281|NCT03066102|144515737|OTHER|||||||8.5e-05||||||The level of statistical significance was set at P \< 0.05.|ANOVA|||"The effects of muscle fatigue on muscle strength of serratus anterior during maximum voluntary isometric muscle contraction.~Muscle fatigue would decrease muscle strength during maximum voluntary isometric muscle contraction.~One-way repeated measures analysis of variance."||||0.000085
72493282|NCT03066102|144515737|OTHER|||||||0.037||||||The level of statistical significance was set at P \< 0.05.|ANOVA|||"The effects of muscle fatigue on muscle strength of upper trapezius during maximum voluntary isometric muscle contraction.~Muscle fatigue would decrease muscle strength during maximum voluntary isometric muscle contraction.~One-way repeated measures analysis of variance."||||0.037
72553954|NCT01754597|144640143|SUPERIORITY|||||||0.714|||||||Wilcoxon (Mann-Whitney)|||||||0.714
72493283|NCT03066102|144515737|OTHER|||||||0.382||||||The level of statistical significance was set at P \< 0.05.|ANOVA|||"The effects of muscle fatigue on muscle strength of lower trapezius during maximum voluntary isometric muscle contraction.~Muscle fatigue would decrease muscle strength during maximum voluntary isometric muscle contraction.~One-way repeated measures analysis of variance."||||0.382
72493284|NCT03066102|144515738|OTHER|||||||0.000467||||||The level of statistical significance was set at P \< 0.05.|ANOVA|||The effects of muscle fatigue on scapular posterior tilt during scaption. Muscle fatigue would change scapular kinematics during scaption. Two way (angle x time) repeated measures. If there was an interaction between time and angle, further one way repeated measures would use to access the effects of time on kinematics changed of scapular posterior tilt during each angle of scaption.||||0.000467
72493285|NCT03066102|144515738|OTHER|||||||0.093||||||The level of statistical significance was adjusted at P\<0.00625. (0.05/8=0.00625)|ANOVA|||"The effects of time on kinematics changed of scapular posterior tilt during ascending 30 degree of scaption.~One-way repeated measures analysis of variance."||||0.093
72553955|NCT01754597|144640144|SUPERIORITY|||||||0.492|||||||Wilcoxon (Mann-Whitney)|||||||0.492
72553956|NCT01754597|144640145|SUPERIORITY|||||||0.183|||||||Wilcoxon (Mann-Whitney)|||||||0.183
72553957|NCT01588236|144640146|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|TWO_SIDED|95.0||||p value for multiple comparison among 3 arms and comparison between investigational drug and placebo|Mixed Models Analysis|||||||>0.05
72493286|NCT03066102|144515738|OTHER|||||||0.062||||||The level of statistical significance was adjusted at P\<0.00625. (0.05/8=0.00625)|ANOVA|||"The effects of time on kinematics changed of scapular posterior tilt during ascending 60 degree of scaption.~One-way repeated measures analysis of variance."||||0.062
72493287|NCT03066102|144515738|OTHER|||||||0.04||||||The level of statistical significance was adjusted at P\<0.00625. (0.05/8=0.00625)|ANOVA|||"The effects of time on kinematics changed of scapular posterior tilt during ascending 90 degree of scaption.~One-way repeated measures analysis of variance."||||0.04
72493288|NCT03066102|144515738|OTHER|||||||0.000147||||||The level of statistical significance was adjusted at P\<0.00625. (0.05/8=0.00625)|ANOVA|||"The effects of time on kinematics changed of scapular posterior tilt during ascending 120 degree of scaption.~One-way repeated measures analysis of variance."||||0.000147
72493289|NCT03066102|144515738|OTHER|||||||1.2e-05||||||The level of statistical significance was adjusted at P\<0.00625. (0.05/8=0.00625)|ANOVA|||"The effects of time on kinematics changed of scapular posterior tilt during descending 120 degree of scaption.~One-way repeated measures analysis of variance."||||0.000012
72493290|NCT03066102|144515738|OTHER|||||||0.007||||||The level of statistical significance was adjusted at P\<0.00625. (0.05/8=0.00625)|ANOVA|||"The effects of time on kinematics changed of scapular posterior tilt during descending 90 degree of scaption.~One-way repeated measures analysis of variance."||||0.007
72493291|NCT03066102|144515738|OTHER|||||||0.059||||||The level of statistical significance was adjusted at P\<0.00625. (0.05/8=0.00625)|ANOVA|||"The effects of time on kinematics changed of scapular posterior tilt during descending 60 degree of scaption.~One-way repeated measures analysis of variance."||||0.059
72493292|NCT03066102|144515738|OTHER|||||||0.032||||||The level of statistical significance was adjusted at P\<0.00625. (0.05/8=0.00625)|ANOVA|||"The effects of time on kinematics changed of scapular posterior tilt during descending 30 degree of scaption.~One-way repeated measures analysis of variance."||||0.032
72493293|NCT03066102|144515738|OTHER|||||||1.5e-05||||||The level of statistical significance was set at P \< 0.05.|ANOVA|||The effects of muscle fatigue on scapular internal rotation during scaption Muscle fatigue would change scapular kinematics during scaption. Two way (angle x time) repeated measures. If there was an interaction between time and angle, further one way repeated measures would use to access the effects of time on kinematics changed of scapular internal rotation during each angle of scaption.||||0.000015
72493294|NCT03066102|144515738|OTHER|||||||0.296||||||The level of statistical significance was adjusted at P\<0.00625. (0.05/8=0.00625)|ANOVA|||"The effects of time on kinematics changed of scapular internal rotation during ascending 30 degree of scaption.~One-way repeated measures analysis of variance."||||0.296
72493295|NCT03066102|144515738|OTHER|||||||0.457||||||The level of statistical significance was adjusted at P\<0.00625. (0.05/8=0.00625)|ANOVA|||"The effects of time on kinematics changed of scapular internal rotation during ascending 60 degree of scaption.~One-way repeated measures analysis of variance."||||0.457
72493296|NCT03066102|144515738|OTHER|||||||0.311||||||The level of statistical significance was adjusted at P\<0.00625. (0.05/8=0.00625)|ANOVA|||"The effects of time on kinematics changed of scapular internal rotation during ascending 90 degree of scaption.~One-way repeated measures analysis of variance."||||0.311
72493297|NCT03066102|144515738|OTHER|||||||0.004||||||The level of statistical significance was adjusted at P\<0.00625. (0.05/8=0.00625)|ANOVA|||"The effects of time on kinematics changed of scapular internal rotation during ascending 120 degree of scaption.~One-way repeated measures analysis of variance."||||0.004
72371140|NCT01309282|144252677|SUPERIORITY_OR_OTHER|||||||0.0225|TWO_SIDED||||||Wilcoxon signed rank test|||||||0.0225
72493298|NCT03066102|144515738|OTHER|||||||0.002||||||The level of statistical significance was adjusted at P\<0.00625. (0.05/8=0.00625)|ANOVA|||"The effects of time on kinematics changed of scapular internal rotation during descending 120 degree of scaption.~One-way repeated measures analysis of variance."||||0.002
72493299|NCT03066102|144515738|OTHER|||||||0.137||||||The level of statistical significance was adjusted at P\<0.00625. (0.05/8=0.00625)|ANOVA|||"The effects of time on kinematics changed of scapular internal rotation during descending 90 degree of scaption.~One-way repeated measures analysis of variance."||||0.137
72371141|NCT01309282|144252678|SUPERIORITY_OR_OTHER|||||||0.0225|TWO_SIDED||||||Wilcoxon signed rank test|||||||0.0225
72493300|NCT03066102|144515738|OTHER|||||||0.636||||||The level of statistical significance was adjusted at P\<0.00625. (0.05/8=0.00625)|ANOVA|||"The effects of time on kinematics changed of scapular internal rotation during descending 60 degree of scaption.~One-way repeated measures analysis of variance."||||0.636
72493301|NCT03066102|144515738|OTHER|||||||0.406||||||The level of statistical significance was adjusted at P\<0.00625. (0.05/8=0.00625)|ANOVA|||"The effects of time on kinematics changed of scapular internal rotation during descending 30 degree of scaption.~One-way repeated measures analysis of variance."||||0.406
72493302|NCT03066102|144515738|OTHER|||||||0.001||||||The level of statistical significance was set at P \< 0.05.|ANOVA|||The effects of muscle fatigue on scapular upward rotation during scaption. Muscle fatigue would change scapular kinematics during scaption. Two way (angle x time) repeated measures. If there was an interaction between time and angle, further one way repeated measures would use to access the effects of time on kinematics changed of scapular upward rotation during each angle of scaption.||||0.001
72493303|NCT03066102|144515738|OTHER|||||||0.65||||||The level of statistical significance was adjusted at P\<0.00625. (0.05/8=0.00625)|ANOVA|||"The effects of time on kinematics changed of scapular upward rotation during ascending 30 degree of scaption.~One-way repeated measures analysis of variance."||||0.650
72553958|NCT01588236|144640147|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|TWO_SIDED|95.0|||||Mixed Models Analysis|||p value for multiple comparison among 3 arms and comparison between investigational drug and placebo||||>0.05
72371142|NCT01309282|144252679|SUPERIORITY_OR_OTHER|||||||0.0904|TWO_SIDED||||||Wilcoxon signed rank test|||||||0.0904
72371143|NCT01309282|144252680|SUPERIORITY_OR_OTHER|||||||0.2969|TWO_SIDED||||||Wilcoxon signed rank test|||||||0.2969
72371144|NCT01387542|144252686|SUPERIORITY_OR_OTHER|||||||0|||||||Friedman test|||||||0.000
72371145|NCT01387542|144252687|SUPERIORITY_OR_OTHER|||||||0.009|||||||Paired t-test|||||||0.009
72371146|NCT01387542|144252688|SUPERIORITY_OR_OTHER|||||||0.001|||||||Paired t-test|||||||0.001
72371147|NCT01387542|144252689|SUPERIORITY_OR_OTHER|||||||0|||||||Paired t-test|||||||0.000
72371148|NCT03601117|144252690|OTHER|This is to test for the antidepressant effect of LDLPFC stimulation. Test is change in score from baseline to approximately 48 hours after the final session.|||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<.001
72493304|NCT03066102|144515738|OTHER|||||||0.141||||||The level of statistical significance was adjusted at P\<0.00625. (0.05/8=0.00625)|ANOVA|||"The effects of time on kinematics changed of scapular upward rotation during ascending 60 degree of scaption.~One-way repeated measures analysis of variance."||||0.141
72493305|NCT03066102|144515738|OTHER|||||||0.021||||||The level of statistical significance was adjusted at P\<0.00625. (0.05/8=0.00625)|ANOVA|||"The effects of time on kinematics changed of scapular upward rotation during ascending 90 degree of scaption.~One-way repeated measures analysis of variance."||||0.021
72493306|NCT03066102|144515738|OTHER|||||||0.005||||||The level of statistical significance was adjusted at P\<0.00625. (0.05/8=0.00625)|ANOVA|||"The effects of time on kinematics changed of scapular upward rotation during ascending 120 degree of scaption.~One-way repeated measures analysis of variance."||||0.005
72493307|NCT03066102|144515738|OTHER|||||||0.083||||||The level of statistical significance was adjusted at P\<0.00625. (0.05/8=0.00625)|ANOVA|||"The effects of time on kinematics changed of scapular upward rotation during descending 120 degree of scaption.~One-way repeated measures analysis of variance."||||0.083
72493308|NCT03066102|144515738|OTHER|||||||0.389||||||The level of statistical significance was adjusted at P\<0.00625. (0.05/8=0.00625)|ANOVA|||"The effects of time on kinematics changed of scapular upward rotation during descending 90 degree of scaption.~One-way repeated measures analysis of variance."||||0.389
72493309|NCT03066102|144515738|OTHER|||||||0.542||||||The level of statistical significance was adjusted at P\<0.00625. (0.05/8=0.00625)|ANOVA|||"The effects of time on kinematics changed of scapular upward rotation during descending 60 degree of scaption.~One-way repeated measures analysis of variance."||||0.542
72493310|NCT03066102|144515738|OTHER|||||||0.263||||||The level of statistical significance was adjusted at P\<0.00625. (0.05/8=0.00625)|ANOVA|||"The effects of time on kinematics changed of scapular upward rotation during descending 30 degree of scaption.~One-way repeated measures analysis of variance."||||0.263
72493311|NCT03066102|144515739|OTHER|||||||0.331||||||The level of statistical significance was set at P \< 0.05.|ANOVA|||"The effects of muscle fatigue on muscle activation of upper trapezius during scaption.~Muscle fatigue would change muscle activation during scaption. Two way (angle x time) repeated measures. If there was an interaction between time and angle, further one way repeated measures would use to access the effects of time on muscle activation changed of upper trapezius during each angle of scaption."||||0.331
72493312|NCT03066102|144515739|OTHER|||||||0.627||||||The level of statistical significance was set at P \< 0.05.|ANOVA|||"The effects of muscle fatigue on muscle activation of lower trapezius during scaption.~Muscle fatigue would change muscle activation during scaption. Two way (angle x time) repeated measures. If there was an interaction between time and angle, further one way repeated measures would use to access the effects of time on muscle activation changed of lower trapezius during each angle of scaption."||||0.627
72493313|NCT03066102|144515739|OTHER|||||||0.042||||||The level of statistical significance was set at P \< 0.05.|ANOVA|||"The effects of muscle fatigue on muscle activation of serratus anterior during scaption.~Muscle fatigue would change muscle activation during scaption. Two way (angle x time) repeated measures. If there was an interaction between time and angle, further one way repeated measures would use to access the effects of time on muscle activation changed of serratus anterior during each angle of scaption."||||0.042
72493314|NCT03066102|144515739|OTHER|||||||0.021||||||The level of statistical significance was adjusted at P\<0.0083. (0.05/6=0.0083)|ANOVA|||"The effects of time on muscle activation changed of serratus anterior during ascending 30\~60 degree of scaption.~One-way repeated measures analysis of variance."||||0.021
72493315|NCT03066102|144515739|OTHER|||||||0.018||||||The level of statistical significance was adjusted at P\<0.0083. (0.05/6=0.0083)|ANOVA|||"The effects of time on muscle activation changed of serratus anterior during ascending 60\~90 degree of scaption.~One-way repeated measures analysis of variance."||||0.018
72553959|NCT01588236|144640148|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.01|TWO_SIDED|95.0||||p value for comparison between overall drug group vs placebo, and between high dose vs placebo|Mixed Models Analysis|||||||<0.01
72553960|NCT01588236|144640149|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05|TWO_SIDED|95.0||||p value for comparison between overall drug group vs placebo, and between low dose vs placebo|Mixed Models Analysis|||||||<0.05
72553961|NCT00834795|144640173|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|95.16||||||90.0|85.69|105.67|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||105.67|85.69|
72553962|NCT00834795|144640174|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|96.27||||||90.0|90.34|102.59|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||102.59|90.34|
72622151|NCT04003142|144774326|SUPERIORITY||Odds Ratio (OR)|3.802||||0.044||95.0|1.157|17.075||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 5||17.075|1.157|0.044
72553963|NCT00834795|144640175|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|96.36||||||90.0|90.2|102.93|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||102.93|90.20|
72553964|NCT00579345|144640181|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was met if lower limit of the 2-sided 95% Clopper-Pearson confidence interval (CI) of the ratio of the postvaccination (Day 22) Geometric Mean Titers (FLU+PV/FLU vaccine alone) was greater than 0.5.|Ratio of GMTs|0.66|||||TWO_SIDED|95.0|0.45|0.98|||||A/H1N1(Day22)|The non-inferiority null hypothesis stated that the FLU+PV vaccine group was non-inferior to the FLU alone group if the lower limit of the 95% CI of the ratio of GMTs between vaccines (FLU+PV/FLU alone) on day 22 was greater than 0.5 for all three vaccine strains.||0.98|0.45|
72553965|NCT00579345|144640181|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was met if lower limit of the 2-sided 95% Clopper-Pearson confidence interval (CI) of the ratio of the postvaccination (Day 22) Geometric Mean Titers (FLU+PV/FLU vaccine alone) was greater than 0.5.|Ratio of GMTs|0.81|||||TWO_SIDED|95.0|0.55|1.19|||||A/H3N2 (Day 22)-criterion was met|The non-inferiority null hypothesis stated that the FLU+PV vaccine group was non-inferior to the FLU alone group if the lower limit of the 95% CI of the ratio of GMTs between vaccines (FLU+PV/FLU alone) on day 22 was greater than 0.5 for all three vaccine strains.||1.19|0.55|
72493316|NCT03066102|144515739|OTHER|||||||0.002||||||The level of statistical significance was adjusted at P\<0.0083. (0.05/6=0.0083)|ANOVA|||"The effects of time on muscle activation changed of serratus anterior during ascending 90\~120 degree of scaption.~One-way repeated measures analysis of variance."||||0.002
72371149|NCT02762370|144252741|SUPERIORITY|||||||0.0452|||||||t-test, 2 sided|||||||0.0452
72371150|NCT02633020|144252748|SUPERIORITY||LS Mean Difference|-4.85|STANDARD_ERROR_OF_MEAN|14.7||0.7451|TWO_SIDED|90.0|-30.26|20.56|||ANCOVA|Analysis of covariance (ANCOVA) with baseline % aberrant IELs vs total IELs as a covariate and treatment group as a fixed effect.||||20.56|-30.26|0.7451
72371151|NCT02633020|144252749|SUPERIORITY||LS Mean Difference|-38.22|STANDARD_ERROR_OF_MEAN|27.48||0.1803|TWO_SIDED|95.0|-95.73|19.29|||ANCOVA|ANCOVA model with baseline % aberrant IELs vs intestinal epithelial cells as a covariate and treatment group as a fixed effect.||||19.29|-95.73|0.1803
72493317|NCT03066102|144515739|OTHER|||||||0.002||||||The level of statistical significance was adjusted at P\<0.0083. (0.05/6=0.0083)|ANOVA|||"The effects of time on muscle activation changed of serratus anterior during descending 120\~90 degree of scaption.~One-way repeated measures analysis of variance."||||0.002
72493318|NCT03066102|144515739|OTHER|||||||0.035||||||The level of statistical significance was adjusted at P\<0.0083. (0.05/6=0.0083)|ANOVA|||"The effects of time on muscle activation changed of serratus anterior during descending 90\~60 degree of scaption.~One-way repeated measures analysis of variance."||||0.035
72493319|NCT03066102|144515739|OTHER|||||||0.05||||||The level of statistical significance was adjusted at P\<0.0083. (0.05/6=0.0083)|ANOVA|||"The effects of time on muscle activation changed of serratus anterior during descending 60\~30 degree of scaption.~One-way repeated measures analysis of variance."||||0.05
72493320|NCT03066102|144515740|OTHER|||||||0.5||||||The level of statistical significance was set at P \< 0.05|ANOVA|||"The effects of muscle fatigue on muscle onset timing of upper trapezius during scaption.~Muscle fatigue would change muscle onset timing during scaption. One-way repeated measures analysis of variance."||||0.5
72553966|NCT00579345|144640181|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was met if lower limit of the 2-sided 95% Clopper-Pearson confidence interval (CI) of the ratio of the postvaccination (Day 22) Geometric Mean Titers (FLU+PV/FLU vaccine alone) was greater than 0.5.|Ratio of GMTs|0.69|||||TWO_SIDED|95.0|0.46|1.02|||||B (Day 22)|The non-inferiority null hypothesis stated that the FLU+PV vaccine group was non-inferior to the FLU alone group if the lower limit of the 95% CI of the ratio of GMTs between vaccines (FLU+PV/FLU alone) on day 22 was greater than 0.5 for all three vaccine strains.||1.02|0.46|
72371152|NCT02633020|144252750|SUPERIORITY||LS Mean Difference|10.67|STANDARD_ERROR_OF_MEAN|24.0||0.6607|TWO_SIDED|95.0|-38.97|60.31|||ANCOVA|ANCOVA model with baseline VH:CD ratio as a covariate and treatment group as a fixed effect.||||60.31|-38.97|0.6607
72371153|NCT02633020|144252751|SUPERIORITY||Odds Ratio (OR)|1.09||||0.9204|TWO_SIDED|95.0|0.2|6.01|||Regression, Logistic|||||6.01|0.20|0.9204
72371154|NCT02633020|144252752|SUPERIORITY||LS Mean Difference|-12.73|STANDARD_ERROR_OF_MEAN|31.34||0.6885|TWO_SIDED|95.0|-77.57|52.12|||ANCOVA|ANCOVA) model with baseline total IEL counts as a covariate and treatment group as a fixed effect.||||52.12|-77.57|0.6885
72371155|NCT02633020|144252753|SUPERIORITY||Ratio of LS Means|1.17|STANDARD_ERROR_OF_MEAN|0.24||0.4469|TWO_SIDED|95.0|0.77|1.8|||Generalized Linear Mixed Model|Generalized linear mixed model with subject as a random effect and treatment group, time (week) and their interaction as fixed effects.||||1.8|0.77|0.4469
72371156|NCT02633020|144252755|SUPERIORITY||LS Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.19||0.4832|TWO_SIDED|95.0|-0.53|0.26|||Linear mixed effects repeated measures|Linear mixed effects repeated measures model with baseline value, treatment group, time point and time point-by-treatment group as fixed effects.||||0.26|-0.53|0.4832
72371157|NCT02633020|144252756|SUPERIORITY||LS Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.24||0.5561|TWO_SIDED|95.0|-0.64|0.35|||Linear mixed effects repeated measures|Linear mixed effects repeated measures model with baseline value, treatment group, time point and a time point-by-treatment group as fixed effects.||||0.35|-0.64|0.5561
72493321|NCT03066102|144515740|OTHER|||||||0.843||||||The level of statistical significance was set at P \< 0.05|ANOVA|||"The effects of muscle fatigue on muscle onset timing of lower trapezius during scaption.~Muscle fatigue would change muscle onset timing during scaption. One-way repeated measures analysis of variance."||||0.843
72371158|NCT01136785|144252757|SUPERIORITY_OR_OTHER|||||||0.01|||||||t-test, 2 sided|||two-sided t test for the change from baseline between the treated and untreated groups.||||0.01
72493322|NCT03066102|144515740|OTHER|||||||0.466||||||The level of statistical significance was set at P \< 0.05|ANOVA|||"The effects of muscle fatigue on muscle onset timing of serratus anterior during scaption.~Muscle fatigue would change muscle onset timing during scaption. One-way repeated measures analysis of variance."||||0.466
72493323|NCT01926782|144515748|SUPERIORITY_OR_OTHER|Alirocumab 300 mg group was compared to placebo group using an appropriate contrast statement.|LS Mean Difference|-52.4|||<|0.0001|TWO_SIDED|97.5|-59.8|-45.0||Threshold for significance ≤ 0.025.|Mixed Models Analysis|||At Week 24||-45.0|-59.8|<0.0001
72493324|NCT01926782|144515748|SUPERIORITY_OR_OTHER|Alirocumab 300 mg group was compared to placebo group using an appropriate contrast statement.|LS Mean Difference|-55.2|||<|0.0001|TWO_SIDED|97.5|-62.3|-48.1||Threshold for significance ≤ 0.025.|Mixed Models Analysis|||Week 21-24||-48.1|-62.3|<0.0001
72493325|NCT01926782|144515749|SUPERIORITY_OR_OTHER|Alirocumab 300 mg group was compared to placebo group using an appropriate contrast statement.|LS Mean Difference|-58.7|||<|0.0001|TWO_SIDED|97.5|-65.0|-52.4||Threshold for significance ≤ 0.025.|Mixed Models Analysis|||At Week 24||-52.4|-65.0|<0.0001
72493326|NCT01926782|144515749|SUPERIORITY_OR_OTHER|Alirocumab 300 mg group was compared to placebo group using an appropriate contrast statement.|LS Mean Difference|-65.0|||<|0.0001|TWO_SIDED|97.5|-70.4|-59.5||Threshold for significance ≤ 0.025|Mixed Models Analysis|||Week 21-24||-59.5|-70.4|< 0.0001
72371159|NCT01136785|144252758|SUPERIORITY_OR_OTHER|||||||0.011|||||||2-sided Paired t-test|||comparing pre and post Interstitial Glucose levels in the active CPAP group||||0.011
72371160|NCT01136785|144252759|SUPERIORITY_OR_OTHER|||||||0.071|||||||t-test, 2 sided|||||||0.071
72371161|NCT01136785|144252760|SUPERIORITY_OR_OTHER|||||||0.754|||||||two-sided paired t-test|||Plasma cortisol pre and post 1-week of active CPAP||||0.754
72553967|NCT00795821|144640191|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Mixed Models Analysis|Model terms included treatment, investigator, visit, treatment-by-visit, baseline score, and baseline-by-visit.||||||<0.001
72371162|NCT01136785|144252761|SUPERIORITY_OR_OTHER|||||||0.308|||||||two-sided paired t-test|||comparing pre and post levels in the active CPAP group||||0.308
72371163|NCT01136785|144252762|SUPERIORITY_OR_OTHER|||||||0.036|||||||two-sided paired t-test|||comparing pre and post levels in the active CPAP group||||0.036
72493327|NCT01926782|144515750|SUPERIORITY_OR_OTHER||LS Mean Difference|-59.0|||<|0.0001|TWO_SIDED|97.5|-64.6|-53.4||Threshold for significance ≤ 0.025.|Mixed Models Analysis|||A hierarchical testing procedure was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when previous endpoint was statistically significant at 0.025 level.||-53.4|-64.6|<0.0001
72493328|NCT01926782|144515751|SUPERIORITY_OR_OTHER||LS Mean Difference|-62.0|||<|0.0001|TWO_SIDED|97.5|-67.7|-56.2||Threshold for significance ≤ 0.025.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-56.2|-67.7|<0.0001
72493329|NCT01926782|144515752|SUPERIORITY_OR_OTHER||LS Mean Difference|-58.7|||<|0.0001|TWO_SIDED|97.5|-64.5|-53.0||Threshold for significance ≤ 0.025.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-53.0|-64.5|<0.0001
72493330|NCT01926782|144515753|SUPERIORITY_OR_OTHER||LS Mean Difference|-56.3|||<|0.0001|TWO_SIDED|97.5|-62.3|-50.3||Threshold for significance ≤ 0.025.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-50.3|-62.3|<0.0001
72493331|NCT01926782|144515754|SUPERIORITY_OR_OTHER||LS Mean Difference|-59.5|||<|0.0001|TWO_SIDED|97.5|-65.0|-54.1||Threshold for significance ≤ 0.025.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-54.1|-65.0|<0.0001
72493332|NCT01926782|144515755|SUPERIORITY_OR_OTHER||LS Mean Difference|-59.4|||<|0.0001|TWO_SIDED|97.5|-64.8|-54.0||Threshold for significance ≤ 0.025.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-54.0|-64.8|<0.0001
72493333|NCT01926782|144515756|SUPERIORITY_OR_OTHER||LS Mean Difference|-39.5|||<|0.0001|TWO_SIDED|97.5|-45.8|-33.1||Threshold for significance ≤ 0.025.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-33.1|-45.8|<0.0001
72493334|NCT01926782|144515757|SUPERIORITY_OR_OTHER||LS Mean Difference|-48.2|||<|0.0001|TWO_SIDED|97.5|-53.2|-43.2||Threshold for significance ≤ 0.025.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-43.2|-53.2|<0.0001
72493335|NCT01926782|144515758|SUPERIORITY_OR_OTHER||LS Mean Difference|-44.5|||<|0.0001|TWO_SIDED|97.5|-49.9|-39.1||Threshold for significance ≤ 0.025.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-39.1|-49.9|<0.0001
72493336|NCT01926782|144515759|SUPERIORITY_OR_OTHER||LS Mean Difference|-50.3|||<|0.0001|TWO_SIDED|97.5|-55.0|-45.6||Threshold for significance ≤ 0.025.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-45.6|-55.0|<0.0001
72493337|NCT01926782|144515760|SUPERIORITY_OR_OTHER||LS Mean Difference|-43.0|||<|0.0001|TWO_SIDED|97.5|-49.9|-36.2||Threshold for significance ≤ 0.025.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-36.2|-49.9|<0.0001
72493338|NCT01926782|144515761|SUPERIORITY_OR_OTHER||LS Mean Difference|-50.0|||<|0.0001|TWO_SIDED|97.5|-55.3|-44.8||Threshold for significance ≤ 0.025.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-44.8|-55.3|<0.0001
72493339|NCT01926782|144515762|SUPERIORITY_OR_OTHER||LS Mean Difference|-49.0|||<|0.0001|TWO_SIDED|97.5|-54.8|-43.3||Threshold for significance ≤ 0.025.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-43.3|-54.8|<0.0001
72493340|NCT01926782|144515763|SUPERIORITY_OR_OTHER||LS Mean Difference|-52.8|||<|0.0001|TWO_SIDED|97.5|-57.6|-47.9||Threshold for significance ≤ 0.025.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-47.9|-57.6|<0.0001
72493341|NCT01926782|144515764|SUPERIORITY_OR_OTHER||LS Mean Difference|-31.4|||<|0.0001|TWO_SIDED|97.5|-36.6|-26.3||Threshold for significance ≤ 0.025.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-26.3|-36.6|<0.0001
72493342|NCT01926782|144515765|SUPERIORITY_OR_OTHER||LS Mean Difference|-35.0|||<|0.0001|TWO_SIDED|97.5|-38.9|-31.1||Threshold for significance ≤ 0.025.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-31.1|-38.9|<0.0001
72493343|NCT01926782|144515766|SUPERIORITY_OR_OTHER||LS Mean Difference|-44.1|||<|0.0001|TWO_SIDED|97.5|-49.0|-39.2||Threshold for significance ≤ 0.025.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-39.2|-49.0|<0.0001
72493344|NCT01926782|144515767|SUPERIORITY_OR_OTHER||LS Mean Difference|-44.8|||<|0.0001|TWO_SIDED|97.5|-49.7|-39.9||Threshold for significance ≤ 0.025.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-39.9|-49.7|<0.0001
72493345|NCT01926782|144515768|SUPERIORITY_OR_OTHER||LS Mean Difference|-49.5|||<|0.0001|TWO_SIDED|97.5|-54.5|-44.6||Threshold for significance ≤ 0.025.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-44.6|-54.5|<0.0001
72553968|NCT00795821|144640193|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||To control for multiple comparisons, the analysis of this secondary outcome measure was pre-specified as a gated secondary objective. As the primary hypothesis was statistically significant, this hypothesis was tested at the 0.05 significance level.|Mixed Models Analysis|Model terms included treatment, investigator, visit, treatment-by-visit, baseline score, and baseline-by-visit.||||||<0.001
72614851|NCT01482221|144759861|SUPERIORITY_OR_OTHER||LS mean difference|-1.18|STANDARD_ERROR_OF_MEAN|1.695||0.63|TWO_SIDED|95.0|-4.519|2.152||The adjusted p-values protect the overall family-wise error rate across the 6 key comparisons of AZD6765 100 mg and 50 mg to placebo (for MADRS change from baseline to 6 weeks and to 12 weeks and for Sustained Response).|Mixed models for repeated measures|||Mixed model repeated measures (MMRM) includes treatment, pooled center, visit, treatment by visit interaction, and baseline MADRS score by visit interaction as explanatory variables. Treatment, visit, treatment by visit interaction, and baseline MADRS score by visit interaction are fixed effects in the model; pooled center is a random effect.||2.152|-4.519|0.630
72371164|NCT01057589|144252771|SUPERIORITY_OR_OTHER|||||||0.697||||||P-value is for Change at End of Triplet Combination Therapy. Threshold for statistical significance was 0.05.|t-test, 2 sided|||||||0.697
72371165|NCT01057589|144252771|SUPERIORITY_OR_OTHER|||||||0.132||||||P-value is for Change at End of Maintenance Therapy. Threshold for statistical significance was 0.05.|t-test, 2 sided|||||||0.132
72371166|NCT01057589|144252772|SUPERIORITY_OR_OTHER|||||||0.223||||||P-value is for Change at End of Triplet Combination Therapy. Threshold for statistical significance was 0.05.|t-test, 2 sided|||||||0.223
72371167|NCT01057589|144252772|SUPERIORITY_OR_OTHER|||||||0.788||||||P-value is for Change at End of Maintenance Therapy. Threshold for statistical significance was 0.05.|t-test, 2 sided|||||||0.788
72493346|NCT01926782|144515769|SUPERIORITY_OR_OTHER||LS Mean Difference|-47.1|||<|0.0001|TWO_SIDED|97.5|-52.2|-42.0||Threshold for significance ≤ 0.025.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-42.0|-52.2|<0.0001
72493347|NCT01926782|144515770|SUPERIORITY_OR_OTHER||LS Mean Difference|-36.4|||<|0.0001|TWO_SIDED|97.5|-40.4|-32.4||Threshold for significance ≤ 0.025.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-32.4|-40.4|<0.0001
72493348|NCT01926782|144515771|SUPERIORITY_OR_OTHER||LS Mean Difference|-32.8|||<|0.0001|TWO_SIDED|97.5|-36.5|-29.1||Threshold for significance ≤ 0.025.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-29.1|-36.5|<0.0001
72493349|NCT01926782|144515772|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|68.0|||<|0.0001|TWO_SIDED|97.5|20.9|221.0||Threshold for significance ≤ 0.025.|Regression, Logistic|Multiple imputation approach followed by logistic regression model.||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Statistical analysis used a multiple imputation approach followed by logistic regression model.||221.0|20.9|<0.0001
72493350|NCT01926782|144515773|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|25.6|||<|0.0001|TWO_SIDED|97.5|13.7|47.8||Threshold for significance ≤ 0.025.|Regression, Logistic|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Statistical analysis used multiple imputation approach followed by logistic regression model.||47.8|13.7|<0.0001
72493351|NCT01926782|144515774|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|280.2|||<|0.0001|TWO_SIDED|97.5|56.7|1385.7||Threshold for significance ≤ 0.025.|Regression, Logistic|Multiple imputation approach followed by logistic regression model.||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||1385.7|56.7|<0.0001
72493352|NCT01926782|144515775|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|41.3|||<|0.0001|TWO_SIDED|97.5|20.3|83.8||Threshold for significance ≤ 0.025.|Regression, Logistic|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Statistical analysis used a multiple imputation approach followed by logistic regression model||83.8|20.3|<0.0001
72493353|NCT01926782|144515776|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|90.6|||<|0.0001|TWO_SIDED|97.5|16.5|498.3||Threshold for significance ≤ 0.025.|Regression, Logistic|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Statistical analysis used a multiple imputation approach followed by logistic regression model.||498.3|16.5|<0.0001
72553969|NCT00795821|144640195|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Mixed Models Analysis|Model terms included treatment, investigator, visit, treatment-by-visit, baseline score, and baseline-by-visit.||||||<0.001
72553970|NCT00795821|144640197|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||Mixed Models Analysis|Model terms included treatment, investigator, visit, treatment-by-visit, baseline score, and baseline-by-visit.||||||0.002
72553971|NCT00795821|144640199|SUPERIORITY_OR_OTHER|||||||0.007||95.0|||||ANCOVA|Model terms included treatment, investigator, and baseline score.||||||0.007
72553972|NCT00795821|144640201|SUPERIORITY_OR_OTHER|||||||0.056||95.0|||||ANCOVA|Model terms included treatment, investigator, and baseline score.||||||0.056
72553973|NCT00795821|144640203|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||Mixed Models Analysis|Model terms included treatment, investigator, visit, treatment-by-visit, baseline score, and baseline-by-visit.||||||0.002
72553974|NCT00795821|144640205|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Mixed Models Analysis|Model terms included treatment, investigator, visit, treatment-by-visit, baseline score, and baseline-by-visit.||||||<0.001
72553975|NCT00795821|144640207|SUPERIORITY_OR_OTHER|||||||0.003||95.0|||||Mixed Models Analysis|Model terms included treatment, investigator, visit, treatment-by-visit, baseline score, and baseline-by-visit.||||||0.003
72553976|NCT00795821|144640209|SUPERIORITY_OR_OTHER|||||||0.009||95.0|||||ANCOVA|Model terms included treatment, investigator, and baseline score.||||||0.009
72553977|NCT00795821|144640211|SUPERIORITY_OR_OTHER|||||||0.008||95.0||||P-value for Severity of Overall Fatigue|Mixed Models Analysis|Model terms included treatment, investigator, visit, treatment-by-visit, baseline score, and baseline-by-visit.||||||0.008
72553978|NCT00795821|144640211|SUPERIORITY_OR_OTHER|||||||0.024||95.0||||P-value for Fatigue Interference with Daily Activities|Mixed Models Analysis|Model terms included treatment, investigator, visit, treatment-by-visit, baseline score, and baseline-by-visit.||||||0.024
72553979|NCT00795821|144640213|SUPERIORITY_OR_OTHER|||||||0.261||95.0||||P-value for participants reporting use of primary doctor|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test controlling for investigator.||||||0.261
72553980|NCT00795821|144640213|SUPERIORITY_OR_OTHER|||||||0.868||95.0||||P-value for participants reporting use of specialist|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test controlling for investigator.||||||0.868
72493354|NCT01926782|144515777|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|49.5|||<|0.0001|TWO_SIDED|97.5|23.4|104.4||Threshold for significance ≤ 0.025.|Regression, Logistic|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Statistical analysis used a multiple imputation approach followed by logistic regression model.||104.4|23.4|<0.0001
72493355|NCT01926782|144515778|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|297.1|||<|0.0001|TWO_SIDED|97.5|27.9|3160.6||Threshold for significance ≤ 0.025.|Regression, Logistic|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Statistical analysis used multiple imputation approach followed by logistic regression model.||3160.6|27.9|<0.0001
72553981|NCT00795821|144640213|SUPERIORITY_OR_OTHER|||||||0.495||95.0||||P-value for participants reporting other diagnostic tests|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test controlling for investigator.||||||0.495
72553982|NCT00795821|144640213|SUPERIORITY_OR_OTHER|||||||0.189||95.0||||P-value for participants reporting prescribed medication|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test controlling for investigator.||||||0.189
72553983|NCT00795821|144640215|SUPERIORITY_OR_OTHER|||||||0.737||95.0||||P-value for suicidal ideation|Fisher Exact|||||||0.737
72553984|NCT00795821|144640217|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||P-value for change in supine systolic blood pressure|Mixed Models Analysis|Model terms included treatment, investigator, visit, treatment-by-visit, baseline score, and baseline-by-visit.||||||0.002
72553985|NCT00795821|144640217|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for change in supine diastolic blood pressure|Mixed Models Analysis|Model terms included treatment, investigator, visit, treatment-by-visit, baseline score, and baseline-by-visit.||||||<0.001
72553986|NCT00795821|144640219|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Mixed Models Analysis|Model terms included treatment, investigator, visit, treatment-by-visit, baseline score, and baseline-by-visit.||||||<0.001
72553987|NCT01285713|144640222|SUPERIORITY_OR_OTHER|||||||0.0003|TWO_SIDED|95.0|||||Paired t-test|||||||0.0003
72553988|NCT00583453|144640244|SUPERIORITY_OR_OTHER|||||||0.674||||||Treatment x day interaction|Wilcoxon (Mann-Whitney)|||||||.674
72553989|NCT00583453|144640245|SUPERIORITY_OR_OTHER|||||||0.018||||||Treatment x day interaction reported as 0.018.|Wilcoxon (Mann-Whitney)|||||||0.018
72553990|NCT00583453|144640246|SUPERIORITY_OR_OTHER|||||||0.214||||||Treatment x day interaction = 0.214|Wilcoxon (Mann-Whitney)|||||||.214
72553991|NCT00583453|144640248|SUPERIORITY_OR_OTHER|||||||0.036||||||treatment x day interaction P = 0.036 Treatment main effect (average day 1 to 10) P = 0.003|Wilcoxon (Mann-Whitney)|||||||0.036
72553992|NCT04523168|144640261|SUPERIORITY|||||||0.0137|||||||Wilcoxon (Mann-Whitney)|||Baseline, 120 days||||0.0137
72553993|NCT04523168|144640263|SUPERIORITY|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||||||0.001
72553994|NCT03868891|144640264|OTHER|||||||1|||||||Wilcoxon signed-rank|||inflation test at 2 months compared with baseline; EMST150 + Eustachi not included because visit 2 measurements only available for 1 participant (2 ears)||||1.00
72553995|NCT03868891|144640264|OTHER|||||||0.734|||||||Wilcoxon signed-rank|||deflation test at 2 months compared with baseline; EMST150 + Eustachi not included because visit 2 measurements only available for 1 participant (2 ears)||||0.734
72553996|NCT03868891|144640265|OTHER|||||||0.25|||||||Wilcoxon signed-rank|||inflation test at 4 months compared with baseline||||0.25
72553997|NCT03868891|144640265|OTHER|||||||0.75|||||||Wilcoxon signed-rank|||deflation test at 4 months compared with baseline||||0.75
72553998|NCT03868891|144640266|OTHER|||||||0.25|||||||Wilcoxon signed-rank|||inflation test at 4 months compared with 2 months||||0.25
72553999|NCT03868891|144640266|OTHER|||||||0.75|||||||Wilcoxon signed-rank|||deflation test at 4 months compared with 2 months||||0.75
72554000|NCT03123094|144640286|OTHER||Slope|0.9533|STANDARD_ERROR_OF_MEAN|0.0803|||TWO_SIDED|95.0|0.781|1.1256|||||Standard error of mean is actually standard error of slope.|Dose proportionality was explored using the power model. Dose proportionality of spesolimab was to be assessed based on the exposure parameter AUC0-∞, determined for the 3 intravenous dose levels (perfect dose proportionality would correspond to a slope of 1).||1.1256|0.7810|
72554001|NCT03123094|144640287|OTHER||Slope|1.0014|STANDARD_ERROR_OF_MEAN|0.0568|||TWO_SIDED|95.0|0.8809|1.1219|||||Standard error of mean is actually standard error of slope.|Dose proportionality was explored using the power model. Dose proportionality of spesolimab was to be assessed based on the exposure parameter Cmax, determined for the 3 intravenous dose levels (perfect dose proportionality would correspond to a slope of 1).||1.1219|0.8809|
72554002|NCT00835536|144640306|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|100.0||||||90.0|93.1|108.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||108|93.1|
72554003|NCT00835536|144640307|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|96.5||||||90.0|92.1|101.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||101|92.1|
72554004|NCT01141374|144640308|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.0667|STANDARD_DEVIATION|17.28||0.352|TWO_SIDED|95.0|-76.0|23.0||The test of hypothesis was conducted with repeated measures ANOVA with Post hoc. It was performed parametric test to compare data and the statistical significance was p\<0.05.|ANOVA|||Null hypothesis: there was no statistical difference among 3 groups (control, needles and seeds) after 4 auriculotherapy sessions.||23.00|-76.00|0.352
72554005|NCT01141374|144640309|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.9067|STANDARD_DEVIATION|19.21||0.023|TWO_SIDED|95.0|-67.0|37.0||It was verified the normality of data distribution and the homogeneity of variance.|ANOVA|As for the comparison between the scores, we used ANOVA for repeated measures.It was made post hoc to find the differences among groups.||It was carried out the analysis of variance (ANOVA) among the groups in the 3rd assessment (after 60 days and 8 sessions). The main objective was to compare the difference among the control group, seeds and needles and to recognize significant outcomes of auriculotherapy by seeds or needles.||37.00|-67.00|0.023
72554006|NCT03769025|144640328|SUPERIORITY|||||||0.1|||||||t-test, 2 sided|||||||.1
72554007|NCT03769025|144640329|SUPERIORITY|||||||0.959|||||||t-test, 2 sided|||||||.959
72554008|NCT03134222|144640378|SUPERIORITY|||||||0.75|||||||Mixed-effect repeated measures model|||||||0.7500
72554009|NCT03134222|144640378|SUPERIORITY|||||||0.3047|||||||Mixed-effect repeated measures model|||||||0.3047
72554010|NCT03134222|144640379|SUPERIORITY|||||||0.8869|||||||Cochran-Mantel-Haenszel|||||||0.8869
72614852|NCT01482221|144759861|SUPERIORITY_OR_OTHER||LS mean difference|-1.21|STANDARD_ERROR_OF_MEAN|1.701||0.476|TWO_SIDED|95.0|-4.563|2.134||The adjusted p-values protect the overall family-wise error rate across the 6 key comparisons of AZD6765 100 mg and 50 mg to placebo (for MADRS change from baseline to 6 weeks and to 12 weeks and for Sustained Response).|Mixed models for repeated measures|||MMRM includes treatment, pooled center, visit, treatment by visit interaction, and baseline MADRS score by visit interaction as explanatory variables. Treatment, visit, treatment by visit interaction, and baseline MADRS score by visit interaction are fixed effects in the model; pooled center is a random effect.||2.134|-4.563|0.476
72614853|NCT01482221|144759862|SUPERIORITY_OR_OTHER||LS mean difference|-2.05|STANDARD_ERROR_OF_MEAN|1.816||0.63|TWO_SIDED|95.0|-5.628|1.522||The adjusted p-values protect the overall family-wise error rate across the 6 key comparisons of AZD6765 100 mg and 50 mg to placebo (for MADRS change from baseline to 6 weeks and to 12 weeks and for Sustained Response).|Mixed models for repeated measures|||Mixed model repeated measures (MMRM) includes treatment, pooled center, visit, treatment by visit interaction, and baseline MADRS score by visit interaction as explanatory variables. Treatment, visit, treatment by visit interaction, and baseline MADRS score by visit interaction are fixed effects in the model; pooled center is a random effect.||1.522|-5.628|0.630
72493356|NCT01926782|144515779|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|77.7|||<|0.0001|TWO_SIDED|97.5|34.1|176.8||Threshold for significance ≤ 0.025.|Regression, Logistic|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Statistical analysis used multiple imputation approach followed by logistic regression model.||176.8|34.1|<0.0001
72493357|NCT01926782|144515780|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-27.7|||<|0.0001|TWO_SIDED|97.5|-37.0|-18.3||Threshold for significance ≤ 0.025.|Regression, Robust|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Statistical analysis used a multiple imputation approach followed by a robust regression model.||-18.3|-37.0|<0.0001
72554011|NCT03134222|144640379|SUPERIORITY|||||||0.3293|||||||Cochran-Mantel-Haenszel|||||||0.3293
72371168|NCT01057589|144252773|SUPERIORITY_OR_OTHER|||||||0.9||||||P-value is for NOD, Triplicate Combination Therapy Cycle 2. Threshold for statistical significance was 0.05.|t-test, 2 sided|||||||0.90
72493358|NCT01926782|144515781|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-29.1|||<|0.0001|TWO_SIDED|97.5|-35.5|-22.7||Threshold for significance ≤ 0.025.|Regression, Robust|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Statistical analysis used a multiple imputation approach followed by a robust regression model.||-22.7|-35.5|<0.0001
72493359|NCT01926782|144515782|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-23.5|||<|0.0001|TWO_SIDED|97.5|-32.4|-14.5||Threshold for significance ≤ 0.025.|Regression, Robust|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Statistical analysis used a multiple imputation approach followed by a robust regression model.||-14.5|-32.4|<0.0001
72493360|NCT01926782|144515783|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-26.6|||<|0.0001|TWO_SIDED|97.5|-32.8|-20.4||Threshold for significance ≤ 0.025.|Regression, Robust|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Statistical analysis used a multiple imputation approach followed by a robust regression model.||-20.4|-32.8|<0.0001
72554012|NCT03134222|144640380|SUPERIORITY|||||||0.7456|||||||Cochran-Mantel-Haenszel|||||||0.7456
72554013|NCT03134222|144640380|SUPERIORITY|||||||0.6407|||||||Cochran-Mantel-Haenszel|||||||0.6407
72554014|NCT03134222|144640381|OTHER||||||<|0.0001|||||||One sample exact binomial test|||||||<0.0001
72554015|NCT03134222|144640381|OTHER||||||<|0.0001|||||||One sample exact binomial test|||||||<0.0001
72554016|NCT03134222|144640382|OTHER||||||<|0.0001|||||||One sample exact binomial test|||||||<0.0001
72554017|NCT03134222|144640382|OTHER||||||<|0.0001|||||||One sample exact binomial test|||||||<0.0001
72554018|NCT03482882|144640391|OTHER||LSM|-10.8|STANDARD_ERROR_OF_MEAN|0.63|<|0.0001|TWO_SIDED|95.0|-12.0|-9.5|||Mixed-effect model repeated measures|||||-9.5|-12.0|<0.0001
72554019|NCT00913627|144640399|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.16|||<|0.001|TWO_SIDED|95.0|12.13|20.19||p-value adjusted for baseline pain severity rating (PSR) and gender|ANOVA|||||20.19|12.13|<0.001
72371169|NCT01057589|144252773|SUPERIORITY_OR_OTHER|||||||0.31||||||P-value is for NOD, Triplicate Combination Therapy Cycle 4. Threshold for statistical significance was 0.05.|t-test, 2 sided|||||||0.31
72554020|NCT00913627|144640399|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|17.0|||<|0.001|TWO_SIDED|95.0|13.02|20.99||p-value adjusted for baseline pain severity rating (PSR) and gender|ANOVA|||||20.99|13.02|<0.001
72554021|NCT00913627|144640399|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.3|||<|0.001|TWO_SIDED|95.0|8.33|16.26||p-value adjusted for baseline pain severity rating (PSR) and gender|ANOVA|||||16.26|8.33|<0.001
72554022|NCT00913627|144640400|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.34|||<|0.001|TWO_SIDED|95.0|4.3|8.38||p-value adjusted for baseline PSR and gender|ANOVA|||||8.38|4.30|<0.001
72554023|NCT00913627|144640400|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.06|||<|0.001|TWO_SIDED|95.0|5.05|9.08||p-value adjusted for baseline PSR and gender|ANOVA|||||9.08|5.05|<0.001
72554024|NCT00913627|144640400|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.05|||<|0.001|TWO_SIDED|95.0|3.04|7.06||p-value adjusted for baseline PSR and gender|ANOVA|||||7.06|3.04|<0.001
72554025|NCT00913627|144640403|SUPERIORITY_OR_OTHER||Cochran-Mantel-Haenszel (CMH)|-72.19|||<|0.001|TWO_SIDED|95.0|-88.56|-55.83||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel||CMH adjusted proportions|8 hours||-55.83|-88.56|<0.001
72554026|NCT00913627|144640403|SUPERIORITY_OR_OTHER||Cochran-Mantel-Haenszel (CMH)|-70.72|||<|0.001|TWO_SIDED|95.0|-87.14|-54.3||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel||CMH adjusted proportions|8 hours||-54.30|-87.14|<0.001
72554027|NCT00913627|144640403|SUPERIORITY_OR_OTHER||Cochran-Mantel-Haenszel (CMH)|-59.6|||<|0.001|TWO_SIDED|95.0|-76.94|-42.27||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel||CMH adjusted proportions|8 hours||-42.27|-76.94|<0.001
72493361|NCT01926782|144515784|SUPERIORITY_OR_OTHER||LS Mean Difference|7.8||||0.0003|TWO_SIDED|97.5|3.1|12.6||Threshold for significance ≤ 0.025.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||12.6|3.1|0.0003
72493362|NCT01926782|144515785|SUPERIORITY_OR_OTHER||LS Mean Difference|5.1||||0.0004|TWO_SIDED|97.5|1.9|8.4||Threshold for significance ≤ 0.025.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||8.4|1.9|0.0004
72493363|NCT01926782|144515786|SUPERIORITY_OR_OTHER||LS Mean Difference|6.9||||0.0004|TWO_SIDED|97.5|2.6|11.1||Threshold for significance ≤ 0.025.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant)||11.1|2.6|0.0004
72493364|NCT01926782|144515787|SUPERIORITY_OR_OTHER||LS Mean Difference|5.2||||0.0007|TWO_SIDED|97.5|1.8|8.7||Threshold for significance ≤ 0.025.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||8.7|1.8|0.0007
72493365|NCT01926782|144515788|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-11.9||||0.0042|TWO_SIDED|97.5|-21.3|-2.6||Threshold for significance ≤ 0.025.|Regression, Robust|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Statistical analysis used a multiple imputation approach followed by a robust regression model.||-2.6|-21.3|0.0042
72554028|NCT00913627|144640403|SUPERIORITY_OR_OTHER||Cochran-Mantel-Haenszel (CMH)|-72.19|||<|0.001|TWO_SIDED|95.0|-88.56|-55.83||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel||CMH adjusted proportions|9 hours||-55.83|-88.56|<0.001
72554029|NCT00913627|144640403|SUPERIORITY_OR_OTHER||Cochran-Mantel-Haenszel (CMH)|-70.72|||<|0.001|TWO_SIDED|95.0|-87.14|-54.3||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel||CMH adjusted proportions|9 hours||-54.30|-87.14|<0.001
72554030|NCT00913627|144640403|SUPERIORITY_OR_OTHER||Cochran-Mantel-Haenszel (CMH)|-57.79|||<|0.001|TWO_SIDED|95.0|-75.43|-40.16||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel||CMH adjusted proportions|9 hours||-40.16|-75.43|<0.001
72554031|NCT00913627|144640403|SUPERIORITY_OR_OTHER||Cochran-Mantel-Haenszel (CMH)|-66.79|||<|0.001|TWO_SIDED|95.0|-83.98|-49.6||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel||CMH adjusted proportions|10 hours||-49.60|-83.98|<0.001
72371170|NCT01057589|144252773|SUPERIORITY_OR_OTHER|||||||0.49||||||P-value is for NOD, Triplicate Combination Therapy Cycle 6. Threshold for statistical significance was 0.05.|t-test, 2 sided|||||||0.49
72554032|NCT00913627|144640403|SUPERIORITY_OR_OTHER||Cochran-Mantel-Haenszel (CMH)|-70.72|||<|0.001|TWO_SIDED|95.0|-87.14|-54.3||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel||CMH adjusted proportions|10 hours||-54.30|-87.14|<0.001
72622152|NCT04003142|144774326|SUPERIORITY||Odds Ratio (OR)|1.342||||0.519||95.0|0.551|3.382||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 6||3.382|0.551|0.519
72371171|NCT01057589|144252773|SUPERIORITY_OR_OTHER|||||||0.95||||||P-value is for NOD, Maintenance Cycle 1. Threshold for statistical significance was 0.05.|t-test, 2 sided|||||||0.95
72554033|NCT00913627|144640403|SUPERIORITY_OR_OTHER||Cochran-Mantel-Haenszel (CMH)|-55.98|||<|0.001|TWO_SIDED|95.0|-73.85|-38.11||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel||CMH adjusted proportions|10 hours||-38.11|-73.85|<0.001
72554034|NCT00913627|144640403|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-63.44|||<|0.001|TWO_SIDED|95.0|-80.82|-46.06||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||11 hours||-46.06|-80.82|<0.001
72554035|NCT00913627|144640403|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-68.88|||<|0.001|TWO_SIDED|95.0|-85.63|-54.14||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||11 hours||-54.14|-85.63|<0.001
72371172|NCT01057589|144252773|SUPERIORITY_OR_OTHER|||||||0.89||||||P-value is for NOD, Maintenance Cycle 3. Threshold for statistical significance was 0.05.|t-test, 2 sided|||||||0.89
72554036|NCT00913627|144640403|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-55.98|||<|0.001|TWO_SIDED|95.0|-73.85|-38.11||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||11 hours||-38.11|-73.85|<0.001
72554037|NCT00913627|144640403|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-63.44|||<|0.001|TWO_SIDED|95.0|-80.82|-46.06||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||12 hours||-46.06|-80.82|<0.001
72554038|NCT00913627|144640403|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-65.28|||<|0.001|TWO_SIDED|95.0|-82.49|-48.07||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||12 hours||-48.07|-82.49|<0.001
72554039|NCT00913627|144640403|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-50.77|||<|0.001|TWO_SIDED|95.0|-69.09|-32.45||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||12 hours||-32.45|-69.09|<0.001
72554040|NCT00913627|144640404|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.34|||<|0.001|TWO_SIDED|95.0|4.18|6.51||p-value adjusted for baseline PSR, and gender|ANOVA|||SPID 0-4||6.51|4.18|<0.001
72554041|NCT00913627|144640404|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.25|||<|0.001|TWO_SIDED|95.0|4.09|6.4||p-value adjusted for baseline PSR and gender|ANOVA|||SPID 0-4||6.40|4.09|<0.001
72554042|NCT00913627|144640404|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.98|||<|0.001|TWO_SIDED|95.0|2.83|5.12||p-value adjusted for baseline PSR and gender|ANOVA|||SPID 0-4||5.12|2.83|<0.001
72554043|NCT00913627|144640404|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.53|||<|0.001|TWO_SIDED|95.0|5.63|9.43||p-value adjusted for baseline PSR and gender|ANOVA|||SPID 4-8||9.43|5.63|<0.001
72554044|NCT00913627|144640404|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.68|||<|0.001|TWO_SIDED|95.0|5.8|9.56||p-value adjusted for baseline PSR and gender|ANOVA|||SPID 4-8||9.56|5.80|<0.001
72554045|NCT00913627|144640404|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.49|||<|0.001|TWO_SIDED|95.0|3.62|7.36||p-value adjusted for baseline PSR and gender|ANOVA|||SPID 4-8||7.36|3.62|<0.001
72371173|NCT01057589|144252773|SUPERIORITY_OR_OTHER|||||||0.36||||||P-value is for NOD, Maintenance Cycle 5. Threshold for statistical significance was 0.05.|t-test, 2 sided|||||||0.36
72371174|NCT01057589|144252773|SUPERIORITY_OR_OTHER|||||||0.18||||||P-value is for NOD, Maintenance Cycle 7. Threshold for statistical significance was 0.05.|t-test, 2 sided|||||||0.18
72554046|NCT00913627|144640405|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.47|||<|0.001|TWO_SIDED|95.0|10.68|16.27||p-value adjusted for baseline PSR and gender|ANOVA|||SPRID 0-4||16.27|10.68|<0.001
72554047|NCT00913627|144640405|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.24|||<|0.001|TWO_SIDED|95.0|10.48|16.01||p-value adjusted for baseline PSR and gender|ANOVA|||SPRID 0-4||16.01|10.48|<0.001
72554048|NCT00913627|144640405|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.08|||<|0.001|TWO_SIDED|95.0|7.33|12.83||p-value adjusted for baseline PSR and gender|ANOVA|||SPRID 0-4||12.83|7.33|<0.001
72554049|NCT00913627|144640405|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|19.21|||<|0.001|TWO_SIDED|95.0|14.71|23.71||p-value adjusted for baseline PSR and gender|ANOVA|||SPRID 4-8||23.71|14.71|<0.001
72614854|NCT01482221|144759862|SUPERIORITY_OR_OTHER||LS mean difference|0.88|STANDARD_ERROR_OF_MEAN|1.83||0.63|TWO_SIDED|95.0|-2.72|4.485||The adjusted p-values protect the overall family-wise error rate across the 6 key comparisons of AZD6765 100 mg and 50 mg to placebo (for MADRS change from baseline to 6 weeks and to 12 weeks and for Sustained Response).|Mixed models for repeated measures|||MMRM includes treatment, pooled center, visit, treatment by visit interaction, and baseline MADRS score by visit interaction as explanatory variables. Treatment, visit, treatment by visit interaction, and baseline MADRS score by visit interaction are fixed effects in the model; pooled center is a random effect.||4.485|-2.720|0.630
72493366|NCT01926782|144515789|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-15.1|||<|0.0001|TWO_SIDED|97.5|-21.5|-8.6||Threshold for significance ≤ 0.025.|Regression, Robust|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Statistical analysis used a multiple imputation approach followed by a robust regression model.||-8.6|-21.5|<0.0001
72493367|NCT01926782|144515790|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-14.1||||0.0004|TWO_SIDED|97.5|-22.9|-5.2||Threshold for significance ≤ 0.025.|Regression, Robust|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Statistical analysis used a multiple imputation approach followed by a robust regression model.||-5.2|-22.9|0.0004
72493368|NCT01926782|144515791|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-13.6|||<|0.0001|TWO_SIDED|97.5|-20.3|-6.9||Threshold for significance ≤ 0.025.|Regression, Robust|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Statistical analysis used a multiple imputation approach followed by a robust regression model.||-6.9|-20.3|<0.0001
72493369|NCT01926782|144515792|SUPERIORITY_OR_OTHER||LS Mean Difference|6.6|||<|0.0001|TWO_SIDED|97.5|3.0|10.2||Threshold for significance ≤ 0.025.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||10.2|3.0|<0.0001
72622153|NCT04003142|144774326|SUPERIORITY||Odds Ratio (OR)|1.961||||0.117||95.0|0.863|4.741||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 6||4.741|0.863|0.117
72371175|NCT01057589|144252773|SUPERIORITY_OR_OTHER|||||||0.47||||||P-value is for EIP, Triplicate Combination Cycle 2. Threshold for statistical significance was 0.05.|t-test, 2 sided|||||||0.47
72493370|NCT01926782|144515793|SUPERIORITY_OR_OTHER||LS Mean Difference|2.7||||0.0306|TWO_SIDED|97.5|-0.1|5.4||Threshold for significance ≤ 0.025.|Mixed Models Analysis||Alirocumab 300 mg vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||5.4|-0.1|0.0306
72493371|NCT00430508|144515800|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.3|||<|0.0001||95.0|-6.97|-3.6|||ANCOVA|||||-3.6|-6.97|<0.0001
72493372|NCT00430508|144515800|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.4|||<|0.0001||95.0|-4.79|-2.03|||ANCOVA|||||-2.03|-4.79|<0.0001
72493373|NCT00430508|144515800|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.9||||0.1788||95.0|-2.32|0.43|||ANCOVA|||||0.43|-2.32|0.1788
72493374|NCT00430508|144515801|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.1|||<|0.0001||95.0|-5.54|-2.6|||ANCOVA|||||-2.6|-5.54|<0.0001
72493375|NCT00430508|144515801|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.2|||<|0.0001||95.0|-4.39|-1.98|||ANCOVA|||||-1.98|-4.39|<0.0001
72493376|NCT00430508|144515801|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.0||||0.1081||95.0|-2.19|0.22|||ANCOVA|||||0.22|-2.19|0.1081
72493377|NCT00430508|144515802|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-7.4|||<|0.0001||95.0|-10.13|-4.66|||ANCOVA|||||-4.66|-10.13|<0.0001
72493378|NCT00430508|144515802|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.2|||<|0.0001||95.0|-7.4|-2.91|||ANCOVA|||||-2.91|-7.4|<0.0001
72493379|NCT00430508|144515802|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.6||||0.0255||95.0|-4.79|-0.31|||ANCOVA|||||-0.31|-4.79|0.0255
72493380|NCT00430508|144515803|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-6.6|||<|0.0001||95.0|-9.0|-4.26|||ANCOVA|||||-4.26|-9.00|<0.0001
72493381|NCT00430508|144515803|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.8|||<|0.0001||95.0|-6.7|-2.81|||ANCOVA|||||-2.81|-6.70|<0.0001
72493382|NCT00430508|144515803|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.7||||0.0812||95.0|-3.66|0.21|||ANCOVA|||||0.21|-3.66|0.0812
72493383|NCT00430508|144515804|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.67||||||95.0|1.69|4.21|||Regression, Logistic|||||4.21|1.69|
72493384|NCT00430508|144515804|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.2||||||95.0|1.5|3.24|||Regression, Logistic|||||3.24|1.50|
72493385|NCT00430508|144515804|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.55||||||95.0|1.07|2.25|||Regression, Logistic|||||2.25|1.07|
72493386|NCT00430508|144515805|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.1|||<|0.0001||95.0|-6.78|-3.36|||ANCOVA|||||-3.36|-6.78|<0.0001
72493387|NCT00430508|144515805|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.2|||<|0.0001||95.0|-4.54|-1.78|||ANCOVA|||||-1.78|-4.54|<0.0001
72493388|NCT00430508|144515805|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.0||||0.1452||95.0|-2.43|0.36|||ANCOVA|||||0.36|-2.43|0.1452
72554050|NCT00913627|144640405|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|19.32|||<|0.001|TWO_SIDED|95.0|14.86|23.78||p-value adjusted for baseline PSR and gender|ANOVA|||SPRID 4-8||23.78|14.86|<0.001
72554051|NCT00913627|144640405|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.87|||<|0.001|TWO_SIDED|95.0|9.44|18.3||p-value adjusted for baseline PSR and gender|ANOVA|||SPRID 4-8||18.30|9.44|<0.001
72554052|NCT00913627|144640405|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.18|||<|0.001|TWO_SIDED|95.0|11.29|21.07||p-value adjusted for baseline PSR and gender|ANOVA|||SPRID 8-12||21.07|11.29|<0.001
72493389|NCT00430508|144515806|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.0|||<|0.0001||95.0|-6.79|-3.17|||ANCOVA|||||-3.17|-6.79|<0.0001
72493390|NCT00430508|144515806|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.3|||<|0.0001||95.0|-4.79|-1.87|||ANCOVA|||||-1.87|-4.79|<0.0001
72493391|NCT00430508|144515806|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.0||||0.1629||95.0|-2.52|0.42|||ANCOVA|||||0.42|-2.52|0.1629
72493392|NCT00430508|144515807|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.5|||<|0.0001||95.0|-7.4|-3.62|||ANCOVA|||||-3.62|-7.40|<0.0001
72493393|NCT00430508|144515807|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.6|||<|0.0009||95.0|-4.12|-1.07|||ANCOVA|||||-1.07|-4.12|<0.0009
72493394|NCT00430508|144515807|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.0||||0.1985||95.0|-2.55|0.53|||ANCOVA|||||0.53|-2.55|0.1985
72493395|NCT03138876|144515813|SUPERIORITY|||||||0.0005|||||||Wilcoxon (Mann-Whitney)|||||||0.0005
72493396|NCT04673786|144515817|EQUIVALENCE|Predefined equivalence margin: -10% to 10%|Treatment difference (%) and 90% CI|2.05|||||TWO_SIDED|90.0|-0.23|4.32|||ANCOVA|Multiple imputation (MI) with the Missing at random (MAR) assumption was applied.||||4.32|-0.23|
72614855|NCT01482221|144759863|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.07|STANDARD_ERROR_OF_MEAN|0.366||0.852|TWO_SIDED|95.0|0.544|2.089||The adjusted p-values protect the overall family-wise error rate across the 6 key comparisons of AZD6765 100 mg and 50 mg to placebo (for MADRS change from baseline to 6 weeks and to 12 weeks and for Sustained Response).|Regression, Logistic|||Logistic regression model including treatment as a fixed effect and the baseline MADRS total score as a covariate.||2.089|0.544|0.852
72493397|NCT00720109|144515828|SUPERIORITY_OR_OTHER_LEGACY||Percentage|40.7|||<|0.001|TWO_SIDED|90.0|30.8|51.4|||Chi-squared|Chi-squared test equivalent to Z-test of proportions.||The a priori plan was to compare MRD positivity rate with that on a prior study, AALL0031 (n=72 Cohorts 1-5 of AALL0031 with 71% MRD positive). Out of 59 patients with end-Induction MRD on AALL0622, 40.7% were MRD positive. Per protocol, rates will be compared with a 2 sample Z-test of proportions, 1-sided test, alpha=5%.||51.4|30.8|<0.001
72493398|NCT00720109|144515829|SUPERIORITY_OR_OTHER_LEGACY||percentage|10.5|||=|0.13|TWO_SIDED|90.0|5.3|19.3|||Binomial Test||The pre-specified threshold for the estimated percentage of MRD positivity at End Consolidation was set to 16%. Results show an upper bound on the (Agresti-Coull) confidence interval of 19.3%.|||19.3|5.3|=0.13
72493399|NCT06245551|144515841|OTHER|The analysis is applied to the All-subjects data.|Mean Difference (Final Values)|-17.52|||<|0.001|TWO_SIDED|95.0|-19.78|-15.25|||Mixed Models Analysis|||||-15.25|-19.78|<0.001
72493400|NCT06142643|144515847|OTHER|"A responder was defined by subjects with a score 1 (very much improved), 2 (much improved) or 3 (improved) on the GAIS.~Inferential analysis for the primary evaluation criterion For the derived outcome responder rate at M1 (1 month after injection) for the GAIS Investigator, a binomial exact test (bilateral approach) vs 60% was applied for the overall score. This test compared the proportion of improvement to 60%."|||||<|0.0001||||||Power of 80%, significant result (alpha = 5%).|t-test, 2 sided|Null hypothesis stated that less than 60% of subjects were responders with GAIS. Under the alternative hypothesis, 75% of subjects were responders.||||||<0.0001
72493401|NCT06142643|144515848|OTHER|"A responder was defined by subjects with a score 1 (very much improved), 2 (much improved) or 3 (improved) on the GAIS.~Inferential analysis for the primary evaluation criterion For the derived outcome responder rate at M1 (1 month after injection) for the GAIS Investigator, a binomial exact test (bilateral approach) vs 60% was applied for the overall score. This test compared the proportion of improvement to 60%."|||||<|0.0001||||||Power of 80%, significant result (alpha = 5%).|t-test, 2 sided|Null hypothesis stated that less than 60% of subjects were responders with GAIS. Under the alternative hypothesis, 75% of subjects were responders.||||||<0.0001
72493402|NCT03485820|144515856|SUPERIORITY||Mean Difference (Net)|1.3||||0.76|TWO_SIDED|95.0|-7.1|9.6||P value shown is for group by time interaction.|Mixed Models Analysis||Between group differences in changes over time (COMPASS vs Education program)|A linear mixed effects model was used to assess the effects of time, group and the interaction of group and time on the outcome. A significant interaction of group and time would indicate that the two groups had significantly different changes in the outcome over time. The model adjusted for race, marital status, living situation, depression, number of days in inpatient rehabilitation, and baseline calendar time.||9.6|-7.1|0.76
72493403|NCT03485820|144515857|SUPERIORITY||Mean Difference (Net)|-1.8||||0.6|TWO_SIDED|95.0|-8.6|5.0||P value shown is for group by time interaction.|Mixed Models Analysis||Between group differences in changes over time (COMPASS vs Education program)|A linear mixed effects model was used to assess the effects of time, group and the interaction of group and time on the outcome. A significant interaction of group and time would indicate that the two groups had significantly different changes in the outcome over time. The model adjusted for race, marital status, living situation, depression, number of days in inpatient rehabilitation, and baseline calendar time.||5.0|-8.6|0.60
72493404|NCT03485820|144515858|SUPERIORITY||Mean Difference (Net)|-0.01||||0.83|TWO_SIDED|95.0|-0.06|0.05||P value shown is for group by time interaction.|Mixed Models Analysis||Between group differences in changes over time (COMPASS vs Education program)|A linear mixed effects model was used to assess the effects of time, group and the interaction of group and time on the outcome. A significant interaction of group and time would indicate that the two groups had significantly different changes in the outcome over time. The model adjusted for race, marital status, living situation, depression, number of days in inpatient rehabilitation, and baseline calendar time.||0.05|-0.06|0.83
72493405|NCT03485820|144515859|SUPERIORITY||Mean Difference (Net)|0.39||||0.046|TWO_SIDED|95.0|0.01|0.77||P value shown is for group by time interaction.|Mixed Models Analysis||Between group differences in changes over time (COMPASS vs Education program)|A linear mixed effects model was used to assess the effects of time, group and the interaction of group and time on the outcome. A significant interaction of group and time would indicate that the two groups had significantly different changes in the outcome over time. The model adjusted for race, marital status, living situation, depression , number of days in inpatient rehabilitation, and baseline calendar time.||0.77|0.01|0.046
72554053|NCT00913627|144640405|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|17.65|||<|0.001|TWO_SIDED|95.0|12.81|22.49||p-value adjusted for baseline PSR and gender|ANOVA|||SPRID 8-12||22.49|12.81|<0.001
72371176|NCT01057589|144252773|SUPERIORITY_OR_OTHER|||||||0.17||||||P-value is for EIP, Triplicate Combination Cycle 4. Threshold for statistical significance was 0.05.|t-test, 2 sided|||||||0.17
72493406|NCT03485820|144515860|SUPERIORITY||Mean Difference (Net)|0.52||||0.02|TWO_SIDED|95.0|0.08|0.96||P value shown is for group by time interaction.|Mixed Models Analysis||Between group differences in changes over time (COMPASS vs Education program)|A linear mixed effects model was used to assess the effects of time, group and the interaction of group and time on the outcome. A significant interaction of group and time would indicate that the two groups had significantly different changes in the outcome over time. The model adjusted for race, marital status, living situation, depression, number of days in inpatient rehabilitation, and baseline calendar time.||0.96|0.08|0.02
72371177|NCT01057589|144252773|SUPERIORITY_OR_OTHER|||||||0.45||||||P-value is for EIP, Triplicate Combination Cycle 6. Threshold for statistical significance was 0.05.|t-test, 2 sided|||||||0.45
72493407|NCT03485820|144515861|SUPERIORITY||Mean Difference (Net)|-10.6||||0.07|TWO_SIDED|95.0|-21.9|0.8||P value shown is for group by time interaction.|Mixed Models Analysis||Between group differences in changes over time (COMPASS vs Education program)|A linear mixed effects model was used to assess the effects of time, group and the interaction of group and time on the outcome. A significant interaction of group and time would indicate that the two groups had significantly different changes in the outcome over time. The model adjusted for race, marital status, living situation, depression, number of days in inpatient rehabilitation, and baseline calendar time.||0.8|-21.9|0.07
72554054|NCT00913627|144640405|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.78|||<|0.001|TWO_SIDED|95.0|7.97|17.59||p-value adjusted for baseline PSR and gender|ANOVA|||SPRID 8-12||17.59|7.97|<0.001
72554055|NCT00913627|144640405|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|41.08|||<|0.001|TWO_SIDED|95.0|31.48|50.69||p-value adjusted for baseline PSR and gender|ANOVA|||SPRID 0-12||50.69|31.48|<0.001
72371178|NCT01057589|144252773|SUPERIORITY_OR_OTHER|||||||0.29||||||P-value is for EIP, Maintenance Cycle 1. Threshold for statistical significance was 0.05.|t-test, 2 sided|||||||0.29
72371179|NCT01057589|144252773|SUPERIORITY_OR_OTHER|||||||0.17||||||P-value is for EIP, Maintenance Cycle 3. Threshold for statistical significance was 0.05.|t-test, 2 sided|||||||0.17
72371180|NCT01057589|144252773|SUPERIORITY_OR_OTHER|||||||0.7||||||P-value is for EIP, Maintenance Cycle 5. Threshold for statistical significance was 0.05.|t-test, 2 sided|||||||0.70
72371181|NCT01057589|144252773|SUPERIORITY_OR_OTHER|||||||0.21||||||P-value is for EIP, Maintenance Cycle 7. Threshold for statistical significance was 0.05.|t-test, 2 sided|||||||0.21
72493408|NCT04685876|144515862|SUPERIORITY|||||||0.355|||||||Regression, Linear|||||||0.355
72371182|NCT01057589|144252773|SUPERIORITY_OR_OTHER|||||||0.85||||||P-value is for UOS, Triplicate Combination Cycle 2. Threshold for statistical significance was 0.05.|t-test, 2 sided|||||||0.85
72371183|NCT01057589|144252773|SUPERIORITY_OR_OTHER|||||||0.13||||||P-value is for UOS, Triplicate Combination Cycle 4. Threshold for statistical significance was 0.05.|t-test, 2 sided|||||||0.13
72371184|NCT01057589|144252773|SUPERIORITY_OR_OTHER|||||||0.03||||||P-value is for UOS, Triplicate Combination Cycle 6. Threshold for statistical significance was 0.05.|t-test, 2 sided|||||||0.03
72371185|NCT01057589|144252773|SUPERIORITY_OR_OTHER|||||||0.71||||||P-value is for UOS, Maintenance Cycle 1. Threshold for statistical significance was 0.05.|t-test, 2 sided|||||||0.71
72493409|NCT04685876|144515862|SUPERIORITY|||||||0.578|||||||Regression, Linear|||||||0.578
72493410|NCT04685876|144515864|SUPERIORITY|||||||0.248|||||||Regression, Cox|||||||0.248
72493411|NCT04685876|144515864|SUPERIORITY|||||||0.297|||||||Regression, Cox|||||||0.297
72493412|NCT04685876|144515865|SUPERIORITY|||||||0.748|||||||Mixed Models Analysis|||||||0.748
72493413|NCT04685876|144515865|SUPERIORITY|||||||0.395|||||||Mixed Models Analysis|||||||0.395
72493414|NCT04685876|144515866|SUPERIORITY|||||||0.152|||||||Regression, Linear|||||||0.152
72554056|NCT00913627|144640405|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|42.66|||<|0.001|TWO_SIDED|95.0|33.15|52.17||p-value adjusted for baseline PSR and gender|ANOVA|||SPRID 0-12||52.17|33.15|<0.001
72554057|NCT00913627|144640405|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|31.08|||<|0.001|TWO_SIDED|95.0|21.63|40.53||p-value adjusted for baseline PSR and gender|ANOVA|||SPRID 0-12||40.53|21.63|<0.001
72554058|NCT00913627|144640406|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.13|||<|0.001|TWO_SIDED|95.0|6.45|9.8||p-value adjusted for baseline PSR and gender|ANOVA|||TOTPAR 0-4||9.80|6.45|<0.001
72554059|NCT00913627|144640406|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.99|||<|0.001|TWO_SIDED|95.0|6.34|9.65||p-value adjusted for baseline PSR and gender|ANOVA|||TOTPAR 0-4||9.65|6.34|<0.001
72554060|NCT00913627|144640406|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.11|||<|0.001|TWO_SIDED|95.0|4.46|7.75||p-value adjusted for baseline PSR and gender|ANOVA|||TOTPAR 0-4||7.75|4.46|<0.001
72554061|NCT00913627|144640406|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.68|||<|0.001|TWO_SIDED|95.0|9.02|14.34||p-value adjusted for baseline PSR and gender|ANOVA|||TOTPAR 4-8||14.34|9.02|<0.001
72554062|NCT00913627|144640406|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.64|||<|0.001|TWO_SIDED|95.0|9.01|14.27||p-value adjusted for baseline PSR and gender|ANOVA|||TOTPAR 4-8||14.27|9.01|<0.001
72371186|NCT01057589|144252773|SUPERIORITY_OR_OTHER|||||||0.34||||||P-value is for UOS, Maintenance Cycle 3. Threshold for statistical significance was 0.05|t-test, 2 sided|||||||0.34
72371187|NCT01057589|144252773|SUPERIORITY_OR_OTHER|||||||0.41||||||P-value is for UOS, Maintenance Cycle 5. Threshold for statistical significance was 0.05|t-test, 2 sided|||||||0.41
72371188|NCT01057589|144252773|SUPERIORITY_OR_OTHER|||||||0.37||||||P-value is for UOS, Maintenance Cycle 7. Threshold for statistical significance was 0.05|t-test, 2 sided|||||||0.37
72371189|NCT02954172|144252774|EQUIVALENCE|the equivalence margin of the ORR ratio was set at (0.75, 1.33).|Odds Ratio (OR)|0.9|||||TWO_SIDED|90.0|0.756|1.077||||||||1.077|0.756|
72371190|NCT02954172|144252775|EQUIVALENCE|||||||0.7066|||||||Log Rank|||||||0.7066
72371191|NCT02954172|144252776|EQUIVALENCE|||||||0.3497|||||||Log Rank|||||||0.3497
72371192|NCT01497366|144252786|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority would be demonstrated if the lower bound of the 2-sided 95% confidence interval (CI) for the difference in SVR12 rates was greater than -15%.|Difference in percentages|0.3|||||TWO_SIDED|95.0|-7.5|8.0|||||The difference in percentages between treatment groups and the 95% CI calculated were based on stratum adjusted Mantel-Haenszel proportions.|||8.0|-7.5|
72493415|NCT04685876|144515866|SUPERIORITY|||||||0.482|||||||Regression, Linear|||||||0.482
72371193|NCT02745080|144252806|SUPERIORITY||Odds Ratio (OR)|1.3||||0.0719|TWO_SIDED|95.0|0.98|1.72|||Regression, Logistic||Odds ratio, 95% confidence interval, and p-value are from a logistic regression model with treatment as a factor and baseline weight as a covariate|||1.72|0.98|0.0719
72371194|NCT02745080|144252807|SUPERIORITY||Odds Ratio (OR)|2.49|||<|0.0001|TWO_SIDED|95.0|1.67|3.71|||Regression, Logistic||Odds ratio, 95% confidence interval, and p-value are from a logistic regression model with treatment as a factor and baseline weight as a covariate|||3.71|1.67|<0.0001
72371195|NCT02745080|144252808|SUPERIORITY||Odds Ratio (OR)|1.18||||0.2251|TWO_SIDED|95.0|0.9|1.55|||Regression, Logistic||Odds ratio, 95% confidence interval, and p-value are from a logistic regression model with treatment as a factor and baseline weight as a covariate|||1.55|0.90|0.2251
72554063|NCT00913627|144640406|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.38|||<|0.001|TWO_SIDED|95.0|5.76|11.0||p-value adjusted for baseline PSR and gender|ANOVA|||TOTPAR 4-8||11.00|5.76|<0.001
72371196|NCT02745080|144252809|SUPERIORITY||least squares (LS) mean change|-0.02|STANDARD_ERROR_OF_MEAN|0.038||0.5465|TWO_SIDED|95.0|-0.1|0.05|||Mixed Models Analysis||Mixed model repeated measures (MMRM) with treatment group, analysis visit as factors, weight/baseline score as covariates, treatment by analysis visit, baseline score by analysis visit as interation terms and unstructured covariance structure|||0.05|-0.10|0.5465
72371197|NCT02745080|144252810|SUPERIORITY||Odds Ratio (OR)|1.3||||0.1498|TWO_SIDED|95.0|0.91|1.87|||Regression, Logistic||Odds ratio, 95% confidence interval, and p-value are from a logistic regression model with treatment as a factor and baseline weight as a covariate|||1.87|0.91|0.1498
72371198|NCT00329524|144252812|NON_INFERIORITY_OR_EQUIVALENCE|Power analysis based on paired t-test.|||||<|0.05||95.0|||||t-test, 2 sided|||||||<.05
72371199|NCT00329524|144252813|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||test for order effect|||||||.05
72371200|NCT05601544|144252821|SUPERIORITY||Least-squares Mean difference|0.22|STANDARD_ERROR_OF_MEAN|0.016|<|0.0001|TWO_SIDED|95.0|0.19|0.25||1-sided p-value was calculated using one-sided type 1 error of 0.025|Mixed Model Analysis|the Kenward and Roger method was used for the calculation of the denominator degrees of freedom.|Least-squares mean difference was calculated as Test minus Control|It was calculated that 41 (for the Multifocal strata) and 6 (for the Sphere strata) participants in each vision group randomized in a 1:1 fashion between the two sequences would have at least a power of 90% (for the Multifocal strata) and a power of 94% (for the Sphere strata) to detect a statistical superiority with respect to visual range.||0.25|0.19|<.0001
72493416|NCT01358864|144515867|SUPERIORITY_OR_OTHER||Adjusted percent difference|52.8|||<|0.0001|TWO_SIDED|95.0|42.4|63.2||Adjusted for genotype and previous response to treatment|Cochran-Mantel-Haenszel|||||63.2|42.4|<0.0001
72493417|NCT01358864|144515867|SUPERIORITY_OR_OTHER||Adjusted percent difference|48.5|||<|0.0001|TWO_SIDED|95.0|38.2|58.9||Adjusted for genotype and previous response to treatment|Cochran-Mantel-Haenszel|||||58.9|38.2|<0.0001
72371201|NCT05601544|144252821|SUPERIORITY||Least-squares Mean difference|0.16|STANDARD_ERROR_OF_MEAN|0.011|<|0.0001|TWO_SIDED|95.0|0.14|0.18||1-sided p-value was calculated using one-sided type 1 error of 0.025|Mixed Model Analysis|the Kenward and Roger method was used for the calculation of the denominator degrees of freedom.|Least-squares mean difference was calculated as Test minus Control|It was calculated that 41 (for the Multifocal strata) and 6 (for the Sphere strata) participants in each vision group randomized in a 1:1 fashion between the two sequences would have at least a power of 90% (for the Multifocal strata) and a power of 94% (for the Sphere strata) to detect a statistical superiority with respect to visual range.||0.18|0.14|<.0001
72371202|NCT05601544|144252824|SUPERIORITY||Median Ratio|0.83||||0.0465|TWO_SIDED|98.33|0.64|1.09||1-sided p-value was calculated using one-sided type 1 error of 0.0083.|Mixed Model Analysis|the Kenward and Roger method was used for the calculation of the denominator degrees of freedom.|Median Ratio was calculated as test over control|It was calculated that 16 participants in each group randomized in a 1:1 fashion between the two sequences would have at least 92% power to detect a statistical superiority with respect to motion detection.||1.09|0.64|0.0465
72371203|NCT05601544|144252825|SUPERIORITY||Least-square Mean Difference|0.14|||<|0.0001|TWO_SIDED|98.33|0.112|0.17||1-sided p-value was calculated using one-sided type 1 error of 0.0083|Mixed Model Analysis|the Kenward and Roger method was used for the calculation of the denominator degrees of freedom.|Least-square Mean difference was calculated as Test minus Control|It was calculated that 29 participants in each group randomized in a 1:1 fashion between the two sequences would have at least 91% power to detect a statistical superiority with respect to motion detection.||0.170|0.112|<.0001
72493418|NCT01358864|144515867|SUPERIORITY_OR_OTHER||Adjusted percent difference|4.4|||||TWO_SIDED|95.0|-6.0|14.9||||||||14.9|-6.0|
72371204|NCT02491632|144252826|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Change between Baseline and Day 8||||<.001
72371205|NCT02491632|144252826|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Change between Baseline and Day 29||||<.001
72371206|NCT02491632|144252826|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Change between Baseline and Day 8||||<.001
72371207|NCT02491632|144252826|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Change between Baseline and Day 29||||<.001
72493419|NCT01358864|144515867|SUPERIORITY_OR_OTHER||Adjusted percent difference|-0.1|||||TWO_SIDED|95.0|-10.9|10.7||||||||10.7|-10.9|
72493420|NCT01358864|144515867|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Normal approximation|||Comparison is based on the Null:Faldaprevir 12 weeks vs historical rate of 20%.||||<0.0001
72371208|NCT02491632|144252827|OTHER||||||=|0.003|||||||Wilcoxon (Mann-Whitney)|||Change between Baseline and Day 8||||=.003
72371209|NCT02491632|144252827|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Change between Baseline and Day 29||||<.001
72493421|NCT01358864|144515867|SUPERIORITY_OR_OTHER|||||||0.0001|TWO_SIDED||||||Normal approximation|||Comparison is based on the Null:Faldaprevir 24 weeks vs historical rate of 20%.||||0.0001
72493422|NCT01358864|144515869|SUPERIORITY_OR_OTHER||Adjusted percent difference|54.7|||<|0.0001|TWO_SIDED|95.0|44.4|65.0||Adjusted for genotype and previous response to treatment|Cochran-Mantel-Haenszel|||||65.0|44.4|<0.0001
72493423|NCT01358864|144515869|SUPERIORITY_OR_OTHER||Adjusted percent difference|50.4|||<|0.0001|TWO_SIDED|95.0|40.1|60.8||Adjusted for genotype and previous response to treatment|Cochran-Mantel-Haenszel|||||60.8|40.1|<0.0001
72493424|NCT01358864|144515869|SUPERIORITY_OR_OTHER||Adjusted percent difference|4.5|||||TWO_SIDED|95.0|-5.8|14.9||||||||14.9|-5.8|
72493425|NCT01358864|144515869|SUPERIORITY_OR_OTHER||Adjusted percent difference|-0.1|||||TWO_SIDED|95.0|-10.9|10.7||||||||10.7|-10.9|
72614856|NCT01482221|144759863|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.08|STANDARD_ERROR_OF_MEAN|0.37||0.821|TWO_SIDED|95.0|0.552|2.115||The adjusted p-values protect the overall family-wise error rate across the 6 key comparisons of AZD6765 100 mg and 50 mg to placebo (for MADRS change from baseline to 6 weeks and to 12 weeks and for Sustained Response).|Regression, Logistic|||Logistic regression model including treatment as a fixed effect and the baseline MADRS total score as a covariate.||2.115|0.552|0.821
72614857|NCT01482221|144759864|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.9|STANDARD_ERROR_OF_MEAN|0.318||0.751|TWO_SIDED|95.0|0.485|1.686|||GEE for repeated measures|||Generalized linear model of the repeated measures (GEE) with logic link including treatment, visit, and treatment by visit interaction as fixed effects and the baseline MADRS total score as a covariate.||1.686|0.485|0.751
72614858|NCT01482221|144759864|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.2|STANDARD_ERROR_OF_MEAN|0.315||0.555|TWO_SIDED|95.0|0.65|2.233|||GEE for repeated measures|||Generalized linear model of the repeated measures (GEE) with logic link including treatment, visit, and treatment by visit interaction as fixed effects and the baseline MADRS total score as a covariate.||2.233|0.650|0.555
72614859|NCT01482221|144759865|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.27|STANDARD_ERROR_OF_MEAN|0.304||0.434|TWO_SIDED|95.0|0.699|2.301|||GEE for repeated measures|||Generalized linear model of the repeated measures (GEE) with logic link including treatment, visit, and treatment by visit interaction as fixed effects and the baseline MADRS total score as a covariate.||2.301|0.699|0.434
72614860|NCT01482221|144759865|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.71|STANDARD_ERROR_OF_MEAN|0.322||0.286|TWO_SIDED|95.0|0.377|1.334|||GEE for repeated measures|||Generalized linear model of the repeated measures (GEE) with logic link including treatment, visit, and treatment by visit interaction as fixed effects and the baseline MADRS total score as a covariate.||1.334|0.377|0.286
72614861|NCT01482221|144759866|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.42|STANDARD_ERROR_OF_MEAN|0.382||0.357|TWO_SIDED|95.0|0.672|3.007|||GEE for repeated measures|||Generalized linear model of the repeated measures (GEE) with logic link including treatment, visit, and treatment by visit interaction as fixed effects and the baseline MADRS total score as a covariate.||3.007|0.672|0.357
72614862|NCT01482221|144759866|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.33|STANDARD_ERROR_OF_MEAN|0.387||0.463|TWO_SIDED|95.0|0.622|2.84|||GEE for repeated measures|||Generalized linear model of the repeated measures (GEE) with logic link including treatment, visit, and treatment by visit interaction as fixed effects and the baseline MADRS total score as a covariate.||2.840|0.622|0.463
72614863|NCT01482221|144759867|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.04|STANDARD_ERROR_OF_MEAN|0.342||0.911|TWO_SIDED|95.0|0.532|2.031|||GEE for repeated measures|||Generalized linear model of the repeated measures (GEE) with logic link including treatment, visit, and treatment by visit interaction as fixed effects and the baseline MADRS total score as a covariate.||2.031|0.532|0.911
72614864|NCT01482221|144759867|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.78|STANDARD_ERROR_OF_MEAN|0.368||0.509|TWO_SIDED|95.0|0.382|1.613|||GEE for repeated measures|||Generalized linear model of the repeated measures (GEE) with logic link including treatment, visit, and treatment by visit interaction as fixed effects and the baseline MADRS total score as a covariate.||1.613|0.382|0.509
72614865|NCT01482221|144759868|SUPERIORITY_OR_OTHER||LS mean difference|-0.17|STANDARD_ERROR_OF_MEAN|1.238||0.889|TWO_SIDED|95.0|-2.609|2.264||Analysis for change in SDS total score from baseline to Week 6|Mixed models for repeated measures|||MMRM includes treatment, pooled center, visit, treatment by visit interaction, and baseline SDS score by visit interaction as explanatory variables. Treatment, visit, treatment by visit interaction, and baseline SDS score by visit interaction are fixed effects in the model; pooled center is a random effect.||2.264|-2.609|0.889
72614866|NCT01482221|144759868|SUPERIORITY_OR_OTHER||LS mean difference|0.01|STANDARD_ERROR_OF_MEAN|1.264||0.992|TWO_SIDED|95.0|-2.477|2.501||Analysis for change in SDS total score from baseline to Week 6|Mixed models for repeated measures|||MMRM includes treatment, pooled center, visit, treatment by visit interaction, and baseline SDS score by visit interaction as explanatory variables. Treatment, visit, treatment by visit interaction, and baseline SDS score by visit interaction are fixed effects in the model; pooled center is a random effect.||2.501|-2.477|0.992
72614867|NCT01482221|144759868|SUPERIORITY_OR_OTHER||LS mean difference|1.11|STANDARD_ERROR_OF_MEAN|1.301||0.392|TWO_SIDED|95.0|-1.448|3.678||Analysis for change in SDS total score from baseline to Week 12|Mixed models for repeated measures|||MMRM includes treatment, pooled center, visit, treatment by visit interaction, and baseline SDS score by visit interaction as explanatory variables. Treatment, visit, treatment by visit interaction, and baseline SDS score by visit interaction are fixed effects in the model; pooled center is a random effect.||3.678|-1.448|0.392
72614868|NCT01482221|144759868|SUPERIORITY_OR_OTHER||LS mean difference|1.29|STANDARD_ERROR_OF_MEAN|1.329||0.333|TWO_SIDED|95.0|-1.327|3.908||Analysis for changed in SDS total score from baseline to Week 12|Mixed models for repeated measures|||MMRM includes treatment, pooled center, visit, treatment by visit interaction, and baseline SDS score by visit interaction as explanatory variables. Treatment, visit, treatment by visit interaction, and baseline SDS score by visit interaction are fixed effects in the model; pooled center is a random effect.||3.908|-1.327|0.333
72371210|NCT02491632|144252827|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Change between Baseline and Day 8||||<.001
72371211|NCT02491632|144252827|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Change between Baseline and Day 29||||<.001
72371212|NCT02491632|144252828|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Change between Baseline and Day 8||||<.001
72554064|NCT00913627|144640406|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.84|||<|0.001|TWO_SIDED|95.0|6.93|12.75||p-value adjusted for baseline PSR and gender|ANOVA|||TOTPAR 8-12||12.75|6.93|<0.001
72371213|NCT02491632|144252828|OTHER||||||<|0.065|||||||Wilcoxon (Mann-Whitney)|||Change between Baseline and Day 29||||<.065
72371214|NCT02491632|144252828|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Change between Baseline and Day 8||||<.001
72371215|NCT02491632|144252828|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Change between Baseline and Day 29||||<.001
72371216|NCT02491632|144252829|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Change between Baseline and Day 8||||<.001
72371217|NCT02491632|144252829|OTHER||||||=|0.3|||||||Wilcoxon (Mann-Whitney)|||Change between Baseline and Day 29||||=.30
72371218|NCT02491632|144252829|OTHER||||||=|0.19|||||||Wilcoxon (Mann-Whitney)|||Change between Baseline and Day 8||||=.19
72554065|NCT00913627|144640406|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.59|||<|0.001|TWO_SIDED|95.0|7.71|13.46||p-value adjusted for baseline PSR and gender|ANOVA|||TOTPAR 8-12||13.46|7.71|<0.001
72371219|NCT02491632|144252829|OTHER||||||=|0.27|||||||Wilcoxon (Mann-Whitney)|||Change between Baseline and Day 29||||=.27
72371220|NCT03818035|144252841|NON_INFERIORITY|One-sided two-group normal approximation Wald Z-test with Mantel-Haenszel stratum weights for 'disease duration' to test for non-inferiority of 100 mg q16w to 100 mg q8w with non-inferiority margin of 10%. Stratified analysis results are reported.|Risk Difference (RD)|-0.6||||0.0013|TWO_SIDED|90.0|-5.7|4.5|||Wald Z-test|||||4.5|-5.7|0.0013
72371221|NCT00982423|144252861|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||t-test, 2 sided|||Comparison between baseline dose of furosemide (3 weeks) versus reduced dose of furosemide (approximately 6 weeks).||||<0.05
72371222|NCT00982423|144252861|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||t-test, 1 sided|||Comparison between GFR taken at baseline dose Furosemide (3 weeks) versus normal GFR||||<0.05
72371223|NCT00982423|144252866|SUPERIORITY_OR_OTHER|||||||0.075|TWO_SIDED||||||t-test, 2 sided|||Comparison between reduced dose Furosemide and baseline dose Furosemide||||0.075
72371224|NCT02712047|144252880|OTHER||Ratio|0.36|||||TWO_SIDED|95.0|0.31|0.43|||||Ratio of FF/VI 100/25mcg versus (Vs) Placebo for Day 1, AM|||0.43|0.31|
72371225|NCT02712047|144252880|OTHER||Ratio|0.33|||||TWO_SIDED|95.0|0.28|0.39|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 1, PM|||0.39|0.28|
72371226|NCT02712047|144252880|OTHER||Ratio|0.38|||||TWO_SIDED|95.0|0.32|0.45|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 2, AM|||0.45|0.32|
72371227|NCT02712047|144252880|OTHER||Ratio|0.37|||||TWO_SIDED|95.0|0.31|0.44|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 2, PM|||0.44|0.31|
72371228|NCT02712047|144252880|OTHER||Ratio|0.46|||||TWO_SIDED|95.0|0.39|0.54|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 3, AM|||0.54|0.39|
72371229|NCT02712047|144252880|OTHER||Ratio|0.47|||||TWO_SIDED|95.0|0.4|0.56|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 3, PM|||0.56|0.40|
72371230|NCT02712047|144252880|OTHER||Ratio|0.56|||||TWO_SIDED|95.0|0.47|0.66|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 4, AM|||0.66|0.47|
72371231|NCT02712047|144252880|OTHER||Ratio|0.58|||||TWO_SIDED|95.0|0.49|0.69|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 4, PM|||0.69|0.49|
72371232|NCT02712047|144252880|OTHER||Ratio|0.63|||||TWO_SIDED|95.0|0.53|0.75|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 5, AM|||0.75|0.53|
72493426|NCT01358864|144515869|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Normal approximation|||Comparison is based on the Null:Faldaprevir 12 weeks vs historical rate of 20%.||||<0.0001
72493427|NCT01358864|144515869|SUPERIORITY_OR_OTHER|||||||0.0001|TWO_SIDED||||||Normal approximation|||Comparison is based on the Null:Faldaprevir 24 weeks vs historical rate of 20%.||||0.0001
72371233|NCT02712047|144252880|OTHER||Ratio|0.67|||||TWO_SIDED|95.0|0.57|0.8|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 5, PM|||0.80|0.57|
72371234|NCT02712047|144252880|OTHER||Ratio|0.67|||||TWO_SIDED|95.0|0.56|0.8|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 6, AM|||0.80|0.56|
72371235|NCT02712047|144252880|OTHER||Ratio|0.62|||||TWO_SIDED|95.0|0.52|0.74|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 6, PM|||0.74|0.52|
72371236|NCT02712047|144252880|OTHER||Ratio|0.6|||||TWO_SIDED|95.0|0.51|0.71|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 7, AM|||0.71|0.51|
72371237|NCT02712047|144252880|OTHER||Ratio|0.62|||||TWO_SIDED|95.0|0.52|0.74|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 7, PM|Ratio of FF/VI 100/25mcg Vs Placebo for Day 8, AM||0.74|0.52|
72371238|NCT02712047|144252880|OTHER||Ratio|0.69|||||TWO_SIDED|95.0|0.58|0.81|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 8, AM|||0.81|0.58|
72371239|NCT02712047|144252880|OTHER||Ratio|0.68|||||TWO_SIDED|95.0|0.57|0.8|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 8, PM|||0.80|0.57|
72371240|NCT02712047|144252880|OTHER||Ratio|0.66|||||TWO_SIDED|95.0|0.56|0.78|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 9, AM|||0.78|0.56|
72371241|NCT02712047|144252880|OTHER||Ratio|0.68|||||TWO_SIDED|95.0|0.57|0.8|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 9, PM|||0.80|0.57|
72371242|NCT02712047|144252880|OTHER||Ratio|0.66|||||TWO_SIDED|95.0|0.55|0.78|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 10, AM|||0.78|0.55|
72371243|NCT02712047|144252880|OTHER||Ratio|0.68|||||TWO_SIDED|95.0|0.58|0.81|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 10, PM|||0.81|0.58|
72371244|NCT02712047|144252880|OTHER||Ratio|0.73|||||TWO_SIDED|95.0|0.61|0.86|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 11, AM|||0.86|0.61|
72371245|NCT02712047|144252880|OTHER||Ratio|0.73|||||TWO_SIDED|95.0|0.61|0.86|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 11, PM|||0.86|0.61|
72371246|NCT02712047|144252880|OTHER||Ratio|0.72|||||TWO_SIDED|95.0|0.61|0.85|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 12, AM|||0.85|0.61|
72371247|NCT02712047|144252880|OTHER||Ratio|0.71|||||TWO_SIDED|95.0|0.6|0.84|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 12, PM|||0.84|0.60|
72371248|NCT02712047|144252880|OTHER||Ratio|0.72|||||TWO_SIDED|95.0|0.61|0.86|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 13, AM|||0.86|0.61|
72371249|NCT02712047|144252880|OTHER||Ratio|0.78|||||TWO_SIDED|95.0|0.66|0.93|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 13, PM|||0.93|0.66|
72371250|NCT02712047|144252880|OTHER||Ratio|0.79|||||TWO_SIDED|95.0|0.66|0.93|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 14, AM|||0.93|0.66|
72371251|NCT02712047|144252880|OTHER||Ratio|0.67|||||TWO_SIDED|95.0|0.56|0.79|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 14, PM|||0.79|0.56|
72371252|NCT02712047|144252880|OTHER||Ratio|0.79|||||TWO_SIDED|95.0|0.66|0.93|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 15, AM|||0.93|0.66|
72371253|NCT02712047|144252880|OTHER||Ratio|0.79|||||TWO_SIDED|95.0|0.66|0.94|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 15, PM|||0.94|0.66|
72371254|NCT02712047|144252880|OTHER||Ratio|0.74|||||TWO_SIDED|95.0|0.62|0.87|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 16, AM|||0.87|0.62|
72371255|NCT02712047|144252880|OTHER||Ratio|0.73|||||TWO_SIDED|95.0|0.61|0.86|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 16, PM|||0.86|0.61|
72493428|NCT03194373|144515880|SUPERIORITY|Power to detect a 20% improvement in disease control rate (DCR). Based on historical data, the DCR in R/M HNSCC with single agent platinum therapy is 40%. We hypothesize that addition of Palbociclib will increase DCR at 12 weeks to 60%. Two-stage design. Type I error rate of 0.059 and power of 0.80 when the true response rate is 0.60 with alpha=0.05. The two-stage sample size calculations assume a null probability of 0.40.|Proportion|33.0|||||TWO_SIDED|95.0|13.0|59.0||||||||59|13|
72493429|NCT03194373|144515881|OTHER||||||||||||||||||Median survival times were computed using the Kaplan-Meier method with standard error computed using Greenwood's formula. All analyses were done using SAS 9.4 software.|||
72493430|NCT03194373|144515882|OTHER||||||||||||||||||Median survival times were computed using the Kaplan-Meier method with standard error computed using Greenwood's formula. All analyses were done using SAS 9.4 software.|||
72371256|NCT02712047|144252880|OTHER||Ratio|0.77|||||TWO_SIDED|95.0|0.65|0.91|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 17, AM|||0.91|0.65|
72371257|NCT02712047|144252880|OTHER||Ratio|0.81|||||TWO_SIDED|95.0|0.65|1.01|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 17, PM|||1.01|0.65|
72371258|NCT02712047|144252880|OTHER||Ratio|0.77|||||TWO_SIDED|95.0|0.61|0.96|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 18, AM|||0.96|0.61|
72371259|NCT02712047|144252880|OTHER||Ratio|0.77|||||TWO_SIDED|95.0|0.59|1.0|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 18, PM|||1.00|0.59|
72371260|NCT02712047|144252880|OTHER||Ratio|0.81|||||TWO_SIDED|95.0|0.63|1.05|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 19, AM|||1.05|0.63|
72371261|NCT02712047|144252880|OTHER||Ratio|0.72|||||TWO_SIDED|95.0|0.52|1.0|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 19, PM|||1.00|0.52|
72371262|NCT02712047|144252880|OTHER||Ratio|0.78|||||TWO_SIDED|95.0|0.56|1.09|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 20, AM|||1.09|0.56|
72371263|NCT02712047|144252880|OTHER||Ratio|0.78|||||TWO_SIDED|95.0|0.53|1.14|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 20, PM|||1.14|0.53|
72432034|NCT03283553|144376538|SUPERIORITY|||||||0.872||||||P-value represents the significance of the term for group assignment.|Regression, Linear|Adjusts for baseline patient education, care partner gender, and patient disease stage.||Quality of communication at 9 months was compared to baseline using linear regression models with the difference in the score as the outcome and a term for group assignment as the main independent variable.||||0.872
72493431|NCT02177201|144515884|SUPERIORITY_OR_OTHER|||||||0.05|TWO_SIDED||||||t-test, 2 sided|||Null hypothesis: The antiemetic effect was not significantly different for two groups in this study||||0.05
72554066|NCT00913627|144640406|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.73|||<|0.001|TWO_SIDED|95.0|4.87|10.59||p-value adjusted for baseline PSR and gender|ANOVA|||TOTPAR 8-12||10.59|4.87|<0.001
72371264|NCT02712047|144252880|OTHER||Ratio|0.85|||||TWO_SIDED|95.0|0.59|1.22|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 21, AM|||1.22|0.59|
72554067|NCT00913627|144640406|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|24.93|||<|0.001|TWO_SIDED|95.0|19.24|30.61||p-value adjusted for baseline PSR and gender|ANOVA|||TOTPAR 0-12||30.61|19.24|<0.001
72554068|NCT00913627|144640406|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|25.66|||<|0.001|TWO_SIDED|95.0|20.03|31.28||p-value adjusted for baseline PSR and gender|ANOVA|||TOTPAR 0-12||31.28|20.03|<0.001
72371265|NCT02712047|144252880|OTHER||Ratio|0.75|||||TWO_SIDED|95.0|0.5|1.13|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 21, PM|||1.13|0.50|
72371266|NCT02712047|144252880|OTHER||Ratio|0.83|||||TWO_SIDED|95.0|0.55|1.25|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 22, AM|||1.25|0.55|
72371267|NCT02712047|144252880|OTHER||Ratio|0.77|||||TWO_SIDED|95.0|0.51|1.16|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 22, PM|||1.16|0.51|
72371268|NCT02712047|144252880|OTHER||Ratio|0.99|||||TWO_SIDED|95.0|0.66|1.49|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 23, AM|||1.49|0.66|
72371269|NCT02712047|144252880|OTHER||Ratio|0.67|||||TWO_SIDED|95.0|0.29|1.51|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 23, PM|||1.51|0.29|
72371270|NCT02712047|144252880|OTHER||Ratio|0.72|||||TWO_SIDED|95.0|0.32|1.64|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 24, AM|||1.64|0.32|
72371271|NCT02712047|144252882|OTHER||Mean Difference (Net)|45.86|||||TWO_SIDED|95.0|23.69|68.03|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 1, AM|||68.03|23.69|
72371272|NCT02712047|144252882|OTHER||Mean Difference (Net)|45.37|||||TWO_SIDED|95.0|23.2|67.55|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 1, PM|||67.55|23.20|
72371273|NCT02712047|144252882|OTHER||Mean Difference (Net)|34.03|||||TWO_SIDED|95.0|11.86|56.21|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 2, AM|||56.21|11.86|
72371274|NCT02712047|144252882|OTHER||Mean Difference (Net)|31.56|||||TWO_SIDED|95.0|9.38|53.73|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 2, PM|||53.73|9.38|
72371275|NCT02712047|144252882|OTHER||Mean Difference (Net)|22.86|||||TWO_SIDED|95.0|0.68|45.03|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 3, AM|||45.03|0.68|
72371276|NCT02712047|144252882|OTHER||Mean Difference (Net)|36.94|||||TWO_SIDED|95.0|14.77|59.12|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 3, PM|||59.12|14.77|
72371277|NCT02712047|144252882|OTHER||Mean Difference (Net)|19.33|||||TWO_SIDED|95.0|-3.0|41.66|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 4, AM|||41.66|-3.00|
72371278|NCT02712047|144252882|OTHER||Mean Difference (Net)|20.85|||||TWO_SIDED|95.0|-1.32|43.03|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 4, PM|||43.03|-1.32|
72371279|NCT02712047|144252882|OTHER||Mean Difference (Net)|16.82|||||TWO_SIDED|95.0|-5.47|39.11|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 5, AM|||39.11|-5.47|
72371280|NCT02712047|144252882|OTHER||Mean Difference (Net)|21.86|||||TWO_SIDED|95.0|-0.41|44.14|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 5, PM|||44.14|-0.41|
72371281|NCT02712047|144252882|OTHER||Mean Difference (Net)|13.05|||||TWO_SIDED|95.0|-9.57|35.67|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 6, AM|||35.67|-9.57|
72371282|NCT02712047|144252882|OTHER||Mean Difference (Net)|28.68|||||TWO_SIDED|95.0|5.38|51.98|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 6, PM|||51.98|5.38|
72371283|NCT02712047|144252882|OTHER||Mean Difference (Net)|17.09|||||TWO_SIDED|95.0|-5.08|39.26|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 7, AM|||39.26|-5.08|
72371284|NCT02712047|144252882|OTHER||Mean Difference (Net)|23.61|||||TWO_SIDED|95.0|0.28|46.94|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 7, PM|||46.94|0.28|
72371285|NCT02712047|144252882|OTHER||Mean Difference (Net)|12.87|||||TWO_SIDED|95.0|-9.3|35.05|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 8, AM|||35.05|-9.30|
72371286|NCT02712047|144252882|OTHER||Mean Difference (Net)|7.5|||||TWO_SIDED|95.0|-14.67|29.68|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 8, PM|||29.68|-14.67|
72371287|NCT02712047|144252882|OTHER||Mean Difference (Net)|3.32|||||TWO_SIDED|95.0|-19.11|25.74|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 9, AM|||25.74|-19.11|
72371288|NCT02712047|144252882|OTHER||Mean Difference (Net)|3.83|||||TWO_SIDED|95.0|-18.34|26.0|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 9, PM|||26.00|-18.34|
72432035|NCT03283553|144376539|SUPERIORITY||||||<|0.001|||||||Fisher Exact|P-value assess between-group differences in proportion of participants who were registered during the 9-month follow up period.||||||<0.001
72493432|NCT02177201|144515884|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Chi-squared, Corrected|||77 patients was needed in each groups for an 20% effect size, 5% alpha and 80% statistical power for postoperative vomiting.||||<0.05
72493433|NCT04209855|144515949|SUPERIORITY||Cox Proportional Hazard|0.63|||<|0.0001|TWO_SIDED|95.0|0.513|0.785|||Log Rank|||||0.785|0.513|<0.0001
72614869|NCT01482221|144759869|SUPERIORITY_OR_OTHER||LS mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.21||0.728|TWO_SIDED|95.0|-0.49|0.34||Analysis for change in CGI-S total score from baseline to Week 6|Mixed models for repeated measures|||MMRM includes treatment, pooled center, visit, treatment by visit interaction, and baseline CGI-S score by visit interaction as explanatory variables. Treatment, visit, treatment by visit interaction, and baseline CGI-S score by visit interaction are fixed effects in the model; pooled center is a random effect.||0.34|-0.49|0.728
72614870|NCT01482221|144759869|SUPERIORITY_OR_OTHER||LS mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.21||0.562|TWO_SIDED|95.0|-0.54|0.29||Analysis for change in CGI-S total score from baseline to Week 6|Mixed models for repeated measures|||MMRM includes treatment, pooled center, visit, treatment by visit interaction, and baseline CGI-S score by visit interaction as explanatory variables. Treatment, visit, treatment by visit interaction, and baseline CGI-S score by visit interaction are fixed effects in the model; pooled center is a random effect.||0.29|-0.54|0.562
72614871|NCT01482221|144759869|SUPERIORITY_OR_OTHER||LS mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.21||0.283|TWO_SIDED|95.0|-0.64|0.19||Analysis for change in CGI-S total score from baseline to Week 12|Mixed models for repeated measures|||MMRM includes treatment, pooled center, visit, treatment by visit interaction, and baseline CGI-S score by visit interaction as explanatory variables. Treatment, visit, treatment by visit interaction, and baseline CGI-S score by visit interaction are fixed effects in the model; pooled center is a random effect.||0.19|-0.64|0.283
72614872|NCT01482221|144759869|SUPERIORITY_OR_OTHER||LS mean difference|0.1|STANDARD_ERROR_OF_MEAN|0.21||0.54|TWO_SIDED|95.0|-0.29|0.55||Analysis for changed in CGI-S total score from baseline to Week 12|Mixed models for repeated measures|||MMRM includes treatment, pooled center, visit, treatment by visit interaction, and baseline CGI-S score by visit interaction as explanatory variables. Treatment, visit, treatment by visit interaction, and baseline CGI-S score by visit interaction are fixed effects in the model; pooled center is a random effect.||0.55|-0.29|0.540
72614873|NCT01482221|144759870|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.74|STANDARD_ERROR_OF_MEAN|0.302||0.067|TWO_SIDED|95.0|0.962|3.141|||GEE for repeated measures|||Generalized linear model of the repeated measures (GEE) with logic link including treatment, visit, and treatment by visit interaction as fixed effects and the baseline CGI-S total score as a covariate.||3.141|0.962|0.067
72614874|NCT01482221|144759870|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.43|STANDARD_ERROR_OF_MEAN|0.297||0.23|TWO_SIDED|95.0|0.798|2.558|||GEE for repeated measures|||Generalized linear model of the repeated measures (GEE) with logic link including treatment, visit, and treatment by visit interaction as fixed effects and the baseline CGI-S total score as a covariate.||2.558|0.798|0.230
72614875|NCT01482221|144759871|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.38|STANDARD_ERROR_OF_MEAN|0.292||0.268|TWO_SIDED|95.0|0.78|2.447|||GEE for repeated measures|||Generalized linear model of the repeated measures (GEE) with logic link including treatment, visit, and treatment by visit interaction as fixed effects and the baseline CGI-S total score as a covariate.||2.447|0.780|0.268
72614876|NCT01482221|144759871|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.97|STANDARD_ERROR_OF_MEAN|0.303||0.909|TWO_SIDED|95.0|0.533|1.75|||GEE for repeated measures|||Generalized linear model of the repeated measures (GEE) with logic link including treatment, visit, and treatment by visit interaction as fixed effects and the baseline CGI-S total score as a covariate.||1.750|0.533|0.909
72614877|NCT01482221|144759872|SUPERIORITY_OR_OTHER||LS mean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.87||0.505|TWO_SIDED|95.0|-2.29|1.13||Analysis for change in QIDS-SR-16 total score from baseline to Week 6|Mixed models for repeated measures|||MMRM includes treatment, pooled center, visit, treatment by visit interaction, and baseline QIDS-SR-16 total score by visit interaction as explanatory variables. Treatment, visit, treatment by visit interaction, and baseline QIDS-SR-16 total score by visit interaction are fixed effects in the model; pooled center is a random effect.||1.13|-2.29|0.505
72614878|NCT01482221|144759872|SUPERIORITY_OR_OTHER||LS mean difference|0.2|STANDARD_ERROR_OF_MEAN|0.88||0.842|TWO_SIDED|95.0|-1.56|1.91||Analysis for change in QIDS-SR-16 total score from baseline to Week 6|Mixed models for repeated measures|||MMRM includes treatment, pooled center, visit, treatment by visit interaction, and baseline QIDS-SR-16 total score by visit interaction as explanatory variables. Treatment, visit, treatment by visit interaction, and baseline QIDS-SR-16 total score by visit interaction are fixed effects in the model; pooled center is a random effect.||1.91|-1.56|0.842
72614879|NCT01482221|144759872|SUPERIORITY_OR_OTHER||LS mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.89||0.788|TWO_SIDED|95.0|-1.98|1.51||Analysis for change in QIDS-SR-16 total score from baseline to Week 12|Mixed models for repeated measures|||MMRM includes treatment, pooled center, visit, treatment by visit interaction, and baseline QIDS-SR-16 total score by visit interaction as explanatory variables. Treatment, visit, treatment by visit interaction, and baseline QIDS-SR-16 total score by visit interaction are fixed effects in the model; pooled center is a random effect.||1.51|-1.98|0.788
72614880|NCT01482221|144759872|SUPERIORITY_OR_OTHER||LS mean difference|1.4|STANDARD_ERROR_OF_MEAN|0.9||0.133|TWO_SIDED|95.0|-0.42|3.12||Analysis for changed in QIDS-SR-16 total score from baseline to Week 12|Mixed models for repeated measures|||MMRM includes treatment, pooled center, visit, treatment by visit interaction, and baseline QIDS-SR-16 total score by visit interaction as explanatory variables. Treatment, visit, treatment by visit interaction, and baseline QIDS-SR-16 total score by visit interaction are fixed effects in the model; pooled center is a random effect.||3.12|-0.42|0.133
72622154|NCT04003142|144774326|SUPERIORITY||Odds Ratio (OR)|1.471||||0.393||95.0|0.612|3.687||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 7||3.687|0.612|0.393
72371289|NCT02712047|144252882|OTHER||Mean Difference (Net)|11.36|||||TWO_SIDED|95.0|-11.11|33.82|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 10, AM|||33.82|-11.11|
72371290|NCT02712047|144252882|OTHER||Mean Difference (Net)|27.73|||||TWO_SIDED|95.0|5.43|50.03|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 10, PM|||50.03|5.43|
72554069|NCT00913627|144640406|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|18.78|||<|0.001|TWO_SIDED|95.0|13.19|24.38||p-value adjusted for baseline PSR and gender|ANOVA|||TOTPAR 0-12||24.38|13.19|<0.001
72371291|NCT02712047|144252882|OTHER||Mean Difference (Net)|14.71|||||TWO_SIDED|95.0|-7.57|36.98|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 11, AM|||36.98|-7.57|
72371292|NCT02712047|144252882|OTHER||Mean Difference (Net)|-6.62|||||TWO_SIDED|95.0|-28.8|15.55|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 11, PM|||15.55|-28.80|
72432036|NCT03283553|144376540|SUPERIORITY|||||||0.003|||||||Fisher Exact|P-value assess between-group differences in proportion of participants who used a patient portal feature at least once during 9-month follow up.||||||0.003
72432037|NCT03283553|144376541|SUPERIORITY||||||<|0.001|||||||Fisher Exact|P-value assess between-group differences in proportion of participants who used a patient portal feature at least once during 9-month follow up.||||||<0.001
72432038|NCT03283553|144376542|SUPERIORITY|||||||0.128||||||P-value assess between-group differences in proportion of participants who used a patient portal feature at least once during 9-month follow up.|Fisher Exact|||||||0.128
72432039|NCT03283553|144376543|SUPERIORITY|||||||0.247||||||P-value assess between-group differences in proportion of participants who used a patient portal feature at least once during 9-month follow up.|Fisher Exact|||||||0.247
72493434|NCT01250379|144515965|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.79||||0.0204|TWO_SIDED|95.0|0.65|0.97|||Log Rank||The 95% confidence interval (CI) was estimated using Cox proportional hazards methodology. The stratification factors used in the analysis were hormone receptor status, first-line PFS, choice of chemotherapy, and lactate dehydrogenase (LDH) level.|||0.97|0.65|0.0204
72554070|NCT00913627|144640407|SUPERIORITY_OR_OTHER||CMH adjusted proportions|13.31||||0.08|TWO_SIDED|95.0|1.26|25.36||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||15 minutes||25.36|1.26|0.080
72371293|NCT02712047|144252882|OTHER||Mean Difference (Net)|4.36|||||TWO_SIDED|95.0|-18.39|27.11|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 12, AM|||27.11|-18.39|
72371294|NCT02712047|144252882|OTHER||Mean Difference (Net)|8.29|||||TWO_SIDED|95.0|-13.99|30.57|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 12, PM|||30.57|-13.99|
72371295|NCT02712047|144252882|OTHER||Mean Difference (Net)|0.64|||||TWO_SIDED|95.0|-21.64|22.92|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 13, AM|||22.92|-21.64|
72371296|NCT02712047|144252882|OTHER||Mean Difference (Net)|-6.88|||||TWO_SIDED|95.0|-29.96|16.19|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 13, PM|||16.19|-29.96|
72371297|NCT02712047|144252882|OTHER||Mean Difference (Net)|28.45|||||TWO_SIDED|95.0|5.76|51.13|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 14, AM|||51.13|5.76|
72371298|NCT02712047|144252882|OTHER||Mean Difference (Net)|12.31|||||TWO_SIDED|95.0|-10.13|34.74|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 14, PM|||34.74|-10.13|
72371299|NCT02712047|144252882|OTHER||Mean Difference (Net)|4.1|||||TWO_SIDED|95.0|-18.16|26.36|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 15, AM|||26.36|-18.16|
72371300|NCT02712047|144252882|OTHER||Mean Difference (Net)|18.87|||||TWO_SIDED|95.0|-3.89|41.63|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 15, PM|||41.63|-3.89|
72371301|NCT02712047|144252882|OTHER||Mean Difference (Net)|6.35|||||TWO_SIDED|95.0|-16.17|28.88|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 16, AM|||28.88|-16.17|
72371302|NCT02712047|144252882|OTHER||Mean Difference (Net)|19.07|||||TWO_SIDED|95.0|-3.27|41.41|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 16, PM|||41.41|-3.27|
72371303|NCT02712047|144252882|OTHER||Mean Difference (Net)|29.51|||||TWO_SIDED|95.0|6.87|52.15|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 17, AM|||52.15|6.87|
72371304|NCT02712047|144252882|OTHER||Mean Difference (Net)|9.64|||||TWO_SIDED|95.0|-17.91|37.19|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 17, PM|||37.19|-17.91|
72371305|NCT02712047|144252882|OTHER||Mean Difference (Net)|24.77|||||TWO_SIDED|95.0|-4.2|53.73|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 18, AM|||53.73|-4.20|
72371306|NCT02712047|144252882|OTHER||Mean Difference (Net)|47.04|||||TWO_SIDED|95.0|14.63|79.45|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 18, PM|||79.45|14.63|
72371307|NCT02712047|144252882|OTHER||Mean Difference (Net)|20.11|||||TWO_SIDED|95.0|-12.3|52.52|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 19, AM|||52.52|-12.30|
72371308|NCT02712047|144252882|OTHER||Mean Difference (Net)|25.13|||||TWO_SIDED|95.0|-15.02|65.27|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 19, PM|||65.27|-15.02|
72371309|NCT02712047|144252882|OTHER||Mean Difference (Net)|-7.89|||||TWO_SIDED|95.0|-48.04|32.25|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 20, AM|||32.25|-48.04|
72371310|NCT02712047|144252882|OTHER||Mean Difference (Net)|8.51|||||TWO_SIDED|95.0|-37.22|54.25|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 20, PM|||54.25|-37.22|
72371311|NCT02712047|144252882|OTHER||Mean Difference (Net)|15.08|||||TWO_SIDED|95.0|-28.5|58.67|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 21, AM|||58.67|-28.50|
72371312|NCT02712047|144252882|OTHER||Mean Difference (Net)|5.19|||||TWO_SIDED|95.0|-45.35|55.73|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 21, PM|||55.73|-45.35|
72371313|NCT02712047|144252883|OTHER||Mean Difference (Net)|0.36|||||TWO_SIDED|95.0|0.26|0.46|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 1, AM|||0.46|0.26|
72371314|NCT02712047|144252883|OTHER||Mean Difference (Net)|0.26|||||TWO_SIDED|95.0|0.16|0.36|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 1, PM|||0.36|0.16|
72371315|NCT02712047|144252883|OTHER||Mean Difference (Net)|0.34|||||TWO_SIDED|95.0|0.24|0.44|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 2, AM|||0.44|0.24|
72432040|NCT03686683|144376544|SUPERIORITY||Odds Ratio (OR)|1.16||||0.4586|TWO_SIDED|95.0|0.78|1.74|||Cochran-Mantel-Haenszel|||||1.74|0.78|0.4586
72432041|NCT00372060|144376549|SUPERIORITY_OR_OTHER||Least-squares Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.1|<|0.001||95.0|-1.0|-0.6|||ANCOVA|Model terms: treatment, prior oral anti-hyperglycemic medication (except for pioglitazone), and baseline HbA1c.||||-0.6|-1.0|<0.001
72432042|NCT00372060|144376550|SUPERIORITY_OR_OTHER||Least-squares Mean Difference|-16.7|STANDARD_ERROR_OF_MEAN|3.39|<|0.001||95.0|-23.4|-10.0|||ANCOVA|Model terms: treatment, prior oral anti-hyperglycemic medication (except for pioglitazone), and baseline fasting plasma glucose.||||-10.0|-23.4|<0.001
72432043|NCT00372060|144376551|SUPERIORITY_OR_OTHER||Least-squares Mean Difference|-49.2|STANDARD_ERROR_OF_MEAN|7.7|<|0.001||95.0|-64.5|-33.9|||ANCOVA|Model terms: treatment, prior oral anti-hyperglycemic medication (except for pioglitazone), and baseline 2-hour postprandial glucose.||||-33.9|-64.5|<0.001
72469422|NCT01018732|144462514|SUPERIORITY_OR_OTHER||ratio of titer|0.6|||||TWO_SIDED|95.0|0.34|1.04|||ANOVA|||Day 29, Men W-135, Pairwise comparison of geometric mean titer||1.04|0.34|
72469423|NCT01018732|144462514|SUPERIORITY_OR_OTHER||ratio of titer|35.0|||||TWO_SIDED|95.0|20.0|60.0|||ANOVA|||Day 29, Men W-135, Pairwise comparison of geometric mean titer||60|20|
72493435|NCT01250379|144515965|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.81||||0.0245|TWO_SIDED|95.0|0.67|0.97|||Log Rank||Unstratified analysis.|||0.97|0.67|0.0245
72554071|NCT00913627|144640407|SUPERIORITY_OR_OTHER||CMH adjusted proportions|16.39||||0.043|TWO_SIDED|95.0|3.73|29.04||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||15 minutes||29.04|3.73|0.043
72432044|NCT01579578|144376553|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.0|STANDARD_ERROR_OF_MEAN|12.23||0.688|TWO_SIDED|95.0|-30.81|20.81||two sided p value|ANCOVA|ANCOVA model including covariates for baseline tumour size, for the time from the baseline scan to randomisation and with a term for HER2 status.|the difference in LS means is estimated|60 patients had been considered to detect a -20% difference in the estimated average percentage change in tumour size at 8 weeks for AZD8931 plus paclitaxel compared to paclitaxel alone at a one-sided significance level of 10% with 90% power. This is based on a standard deviation of 30% for tumour data (on an absolute scale)||20.81|-30.81|0.688
72432045|NCT02987829|144376571|OTHER|||||||||||||||||Determination of the maximum tolerated dose.|One dose limiting toxicity occurred at 320 mg daily of grade 3 QTc prolongation therefore the 280 mg dose was determined to be the maximum tolerated dose and selected as the phase 2 dose.|||
72432046|NCT00647348|144376579|OTHER|intention-to-treat analysis||||||0.003|||||||BBSI=brain boundary shift integral|||||||0.003
72432047|NCT00647348|144376580|SUPERIORITY|||||||0.05||||||EDSS,mean score at 24 months was compared between treatment groups using an ANCOVA model adjusting for baseline score and minimisation variables.|ANCOVA|EDSS,mean score at 24 months was compared between treatment groups using an ANCOVA model adjusting for baseline score and minimisation variables.||||||0.05
72432048|NCT00714233|144376589|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||t-test, 2 sided|||Paired t-test to analyze BMI at baseline and 24 weeks||||<0.05
72432049|NCT01454362|144376614|SUPERIORITY|||||||0.17|||||||t-test, 2 sided|||||||0.17
72493436|NCT01250379|144515966|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.59||||0.0088|TWO_SIDED|95.0|0.4|0.88|||Log Rank|||Subgroup analysis: HR-neg||0.88|0.40|0.0088
72554072|NCT00913627|144640407|SUPERIORITY_OR_OTHER||CMH adjusted proportions|5.39||||0.354|TWO_SIDED|95.0|-4.62|15.4||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||15 minutes||15.40|-4.62|0.354
72554073|NCT00913627|144640407|SUPERIORITY_OR_OTHER||CMH adjusted proportions|48.65|||<|0.001|TWO_SIDED|95.0|33.34|63.96||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||30 minutes||63.96|33.34|<0.001
72371316|NCT02712047|144252883|OTHER||Mean Difference (Net)|0.24|||||TWO_SIDED|95.0|0.14|0.34|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 2, PM|||0.34|0.14|
72432050|NCT01454362|144376615|SUPERIORITY|||||||0.43|||||||t-test, 2 sided|||||||0.43
72432051|NCT01454362|144376616|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
72432052|NCT01454362|144376617|SUPERIORITY|||||||0.001|||||||t-test, 2 sided|||||||0.001
72432053|NCT01454362|144376618|SUPERIORITY|||||||0.003|||||||t-test, 2 sided|||||||0.003
72432054|NCT00797225|144376619|SUPERIORITY||LS Mean Difference|-0.49|STANDARD_ERROR_OF_MEAN|0.25||0.0464|TWO_SIDED|95.0|-0.98|-0.01|||Mixed-effects Repeated Measures Model|||Analysis at Week 4. The change from baseline in monthly mean values of the NRS for overall endometriosis-associated pelvic pain was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.||-0.01|-0.98|0.0464
72432055|NCT00797225|144376619|SUPERIORITY||LS Mean Difference|-0.65|STANDARD_ERROR_OF_MEAN|0.24||0.008|TWO_SIDED|95.0|-1.13|-0.17|||Mixed-effects Repeated Measures Model|||Analysis at Week 4. The change from baseline in monthly mean values of the NRS for overall endometriosis-associated pelvic pain was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.||-0.17|-1.13|0.0080
72432056|NCT00797225|144376619|SUPERIORITY||LS Mean Difference|-0.59|STANDARD_ERROR_OF_MEAN|0.24||0.0159|TWO_SIDED|95.0|-1.08|-0.11|||Mixed-effects Repeated Measures Model|||Analysis at Week 4. The change from baseline in monthly mean values of the NRS for overall endometriosis-associated pelvic pain was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.||-0.11|-1.08|0.0159
72493437|NCT01250379|144515966|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.84||||0.1196|TWO_SIDED|95.0|0.67|1.05|||Log Rank|||Subgroup analysis: HR-pos/HER-neg||1.05|0.67|0.1196
72554074|NCT00913627|144640407|SUPERIORITY_OR_OTHER||CMH adjusted proportions|51.94|||<|0.001|TWO_SIDED|95.0|37.15|66.73||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||30 minutes||66.73|37.15|<0.001
72371317|NCT02712047|144252883|OTHER||Mean Difference (Net)|0.26|||||TWO_SIDED|95.0|0.16|0.36|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 3, AM|||0.36|0.16|
72371318|NCT02712047|144252883|OTHER||Mean Difference (Net)|0.18|||||TWO_SIDED|95.0|0.08|0.28|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 3, PM|||0.28|0.08|
72371319|NCT02712047|144252883|OTHER||Mean Difference (Net)|0.24|||||TWO_SIDED|95.0|0.14|0.34|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 4, AM|||0.34|0.14|
72432057|NCT00797225|144376619|SUPERIORITY||LS Mean Difference|-0.33|STANDARD_ERROR_OF_MEAN|0.29||0.2563|TWO_SIDED|95.0|-0.89|0.24|||Mixed-effects Repeated Measures Model|||Analysis at Week 8. The change from baseline in monthly mean values of the NRS for overall endometriosis-associated pelvic pain was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.||0.24|-0.89|0.2563
72432058|NCT00797225|144376619|SUPERIORITY||LS Mean Difference|-0.65|STANDARD_ERROR_OF_MEAN|0.28||0.0239|TWO_SIDED|95.0|-1.21|-0.09|||Mixed-effects Repeated Measures Model|||Analysis at Week 8. The change from baseline in monthly mean values of the NRS for overall endometriosis-associated pelvic pain was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.||-0.09|-1.21|0.0239
72493438|NCT01250379|144515966|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.62||||0.011|TWO_SIDED|95.0|0.43|0.9|||Log Rank|||Subgroup analysis: PFS \<6 months||0.90|0.43|0.0110
72493439|NCT01250379|144515966|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.82||||0.0816|TWO_SIDED|95.0|0.65|1.03|||Log Rank|||Subgroup analysis: PFS ≥6 months||1.03|0.65|0.0816
72493440|NCT01250379|144515966|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.55||||0.0395|TWO_SIDED|95.0|0.31|0.98|||Log Rank|||Subgroup analysis: taxane chemo||0.98|0.31|0.0395
72493441|NCT01250379|144515966|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.84||||0.1385|TWO_SIDED|95.0|0.68|1.06|||Log Rank|||Subgroup analysis: non-taxane chemo||1.06|0.68|0.1385
72493442|NCT01250379|144515966|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.41||||0.0029|TWO_SIDED|95.0|0.22|0.75|||Log Rank|||Subgroup analysis: vinorelbine chemo||0.75|0.22|0.0029
72493443|NCT01250379|144515966|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.77||||0.0171|TWO_SIDED|95.0|0.62|0.96|||Log Rank|||Subgroup analysis: LDH ≤ 1.5 ULN||0.96|0.62|0.0171
72493444|NCT01250379|144515966|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.73||||0.1797|TWO_SIDED|95.0|0.46|1.16|||Log Rank|||Subgroup analysis: LDH \> 1.5 ULN||1.16|0.46|0.1797
72493445|NCT01250379|144515966|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.77||||0.0229|TWO_SIDED|95.0|0.62|0.97|||Log Rank|||Subgroup analysis: \< 65 years of age||0.97|0.62|0.0229
72493446|NCT01250379|144515966|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.77||||0.2139|TWO_SIDED|95.0|0.51|1.16|||Log Rank|||Subgroup analysis: ≥ 65 years of age||1.16|0.51|0.2139
72493447|NCT01250379|144515966|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.73||||0.0021|TWO_SIDED|95.0|0.59|0.89|||Log Rank|||Subgroup analysis: \< 70 years of age||0.89|0.59|0.0021
72493448|NCT01250379|144515966|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.24||||0.5216|TWO_SIDED|95.0|0.64|2.39|||Log Rank|||Subgroup analysis: ≥ 70 years of age||2.39|0.64|0.5216
72493449|NCT01250379|144515966|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.74||||0.0148|TWO_SIDED|95.0|0.58|0.94|||Log Rank|||Subgroup analysis: \< 3 metastatic organ sites||0.94|0.58|0.0148
72493450|NCT01250379|144515966|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.84||||0.3102|TWO_SIDED|95.0|0.61|1.17|||Log Rank|||Subgroup analysis: ≥ 3 metastatic organ sites||1.17|0.61|0.3102
72493451|NCT01250379|144515966|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.82||||0.0967|TWO_SIDED|95.0|0.64|1.04|||Log Rank|||Subgroup analysis: B-free ≤ 6 weeks||1.04|0.64|0.0967
72554075|NCT00913627|144640407|SUPERIORITY_OR_OTHER||CMH adjusted proportions|36.8|||<|0.001|TWO_SIDED|95.0|22.62|50.98||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||30 minutes||50.98|22.62|<0.001
72371320|NCT02712047|144252883|OTHER||Mean Difference (Net)|0.17|||||TWO_SIDED|95.0|0.07|0.27|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 4, PM|||0.27|0.07|
72493452|NCT01250379|144515966|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.72||||0.0489|TWO_SIDED|95.0|0.51|1.0|||Log Rank|||Subgroup analysis: B-free \> 6 weeks||1.00|0.51|0.0489
72493453|NCT01250379|144515966|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.62||||0.0176|TWO_SIDED|95.0|0.41|0.92|||Log Rank|||Subgroup analysis: D-free ≤ 24 months||0.92|0.41|0.0176
72493454|NCT01250379|144515966|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.85||||0.2318|TWO_SIDED|95.0|0.66|1.11|||Log Rank|||Subgroup analysis: D-free \> 24 months||1.11|0.66|0.2318
72493455|NCT01250379|144515966|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.52||||0.0568|TWO_SIDED|95.0|0.26|1.03|||Log Rank|||Subgroup analysis: D-free ≤ 12 months||1.03|0.26|0.0568
72554076|NCT00913627|144640407|SUPERIORITY_OR_OTHER||CMH adjusted proportions|57.39|||<|0.001|TWO_SIDED|95.0|41.2|73.57||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||45 minutes||73.57|41.20|<0.001
72493456|NCT01250379|144515966|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.83||||0.1143|TWO_SIDED|95.0|0.66|1.05|||Log Rank|||Subgroup analysis: D-free \> 12 months||1.05|0.66|0.1143
72493457|NCT01250379|144515967|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.1||||0.3457|TWO_SIDED|95.0|-4.2|12.4|||Chi-squared||The 95% CI was estimated using Hauck-Anderson methodology.|||12.4|-4.2|0.3457
72493458|NCT01250379|144515969|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.01||||0.9825|TWO_SIDED|95.0|0.51|1.99|||Log Rank||The 95% CI was estimated using Cox proportional hazards methodology. The stratification factors used in stratified analysis were hormone receptor status, first-line PFS, choice of chemotherapy, and LDH level.|||1.99|0.51|0.9825
72493459|NCT01250379|144515969|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.31||||0.3601|TWO_SIDED|95.0|0.73|2.34|||Log Rank||Unstratified analysis.|||2.34|0.73|0.3601
72493460|NCT01250379|144515972|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.79||||0.108|TWO_SIDED|95.0|0.59|1.06|||Log Rank||The 95% CI was estimated using Cox proportional hazards methodology. The stratification factors used in stratified analysis were hormone receptor status, first-line PFS, choice of chemotherapy, and LDH level.|||1.06|0.59|0.1080
72493461|NCT01250379|144515972|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.78||||0.0625|TWO_SIDED|95.0|0.59|1.02|||Log Rank||Unstratified analysis.|||1.02|0.59|0.0625
72493462|NCT01250379|144515974|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.85||||0.1349|TWO_SIDED|95.0|0.68|1.05|||Log Rank||The 95% CI was estimated using Cox proportional hazards methodology. The stratification factors used in stratified analysis were hormone receptor status, first-line PFS, choice of chemotherapy, and LDH level.|||1.05|0.68|0.1349
72493463|NCT01250379|144515974|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.84||||0.0863|TWO_SIDED|95.0|0.68|1.03|||Log Rank||Unstratified analysis.|||1.03|0.68|0.0863
72493464|NCT01250379|144515976|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.81||||0.0744|TWO_SIDED|95.0|0.65|1.02|||Log Rank||The 95% CI was estimated using Cox proportional hazards methodology. The stratification factors used in stratified analysis were hormone receptor status, first-line PFS, choice of chemotherapy, and LDH level.|||1.02|0.65|0.0744
72493465|NCT01250379|144515976|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.81||||0.0503|TWO_SIDED|95.0|0.66|1.0|||Log Rank||Unstratified analysis.|||1.00|0.66|0.0503
72493466|NCT01250379|144515979|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.96||||0.7253|TWO_SIDED|95.0|0.76|1.21|||Log Rank||The 95% CI was estimated using Cox proportional hazards methodology. The stratification factors used in stratified analysis were hormone receptor status, first-line PFS, choice of chemotherapy, and LDH level.|||1.21|0.76|0.7253
72493467|NCT01250379|144515979|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.93||||0.5332|TWO_SIDED|95.0|0.75|1.16|||Log Rank||Unstratified analysis.|||1.16|0.75|0.5332
72554077|NCT00913627|144640407|SUPERIORITY_OR_OTHER||CMH adjusted proportions|66.67|||<|0.001|TWO_SIDED|95.0|51.56|81.78||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||45 minutes||81.78|51.56|<0.001
72554078|NCT00913627|144640407|SUPERIORITY_OR_OTHER||CMH adjusted proportions|50.2|||<|0.001|TWO_SIDED|95.0|34.2|66.21||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||45 minutes||66.21|34.20|<0.001
72554079|NCT00913627|144640407|SUPERIORITY_OR_OTHER||CMH adjusted proportions|67.64|||<|0.001|TWO_SIDED|95.0|51.36|83.93||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||60 minutes||83.93|51.36|<0.001
72371321|NCT02712047|144252883|OTHER||Mean Difference (Net)|0.07|||||TWO_SIDED|95.0|-0.03|0.17|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 5, AM|||0.17|-0.03|
72554080|NCT00913627|144640407|SUPERIORITY_OR_OTHER||CMH adjusted proportions|70.61|||<|0.001|TWO_SIDED|95.0|55.16|86.05||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||60 minutes||86.05|55.16|<0.001
72554081|NCT00913627|144640407|SUPERIORITY_OR_OTHER||CMH adjusted proportions|51.85|||<|0.001|TWO_SIDED|95.0|34.32|69.38||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||60 minutes||69.38|34.32|<0.001
72554082|NCT00913627|144640407|SUPERIORITY_OR_OTHER||CMH adjusted proportions|69.33|||<|0.001|TWO_SIDED|95.0|53.33|85.33||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||90 minutes||85.33|53.33|<0.001
72554083|NCT00913627|144640407|SUPERIORITY_OR_OTHER||CMH adjusted proportions|74.21|||<|0.001|TWO_SIDED|95.0|59.29|89.14||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||90 minutes||89.14|59.29|<0.001
72554084|NCT00913627|144640407|SUPERIORITY_OR_OTHER||CMH adjusted proportions|58.86|||<|0.001|TWO_SIDED|95.0|41.88|75.84||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||90 minutes||75.84|41.88|<0.001
72554085|NCT00913627|144640407|SUPERIORITY_OR_OTHER||CMH adjusted proportions|69.33|||<|0.001|TWO_SIDED|95.0|53.33|85.33||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||120 minutes||85.33|53.33|<0.001
72554086|NCT00913627|144640407|SUPERIORITY_OR_OTHER||CMH adjusted proportions|77.82|||<|0.001|TWO_SIDED|95.0|63.57|92.06||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||120 minutes||92.06|63.57|<0.001
72554087|NCT00913627|144640407|SUPERIORITY_OR_OTHER||CMH adjusted proportions|58.86|||<|0.001|TWO_SIDED|95.0|41.88|75.84||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||120 minutes||75.84|41.88|<0.001
72554088|NCT00913627|144640407|SUPERIORITY_OR_OTHER||CMH adjusted proportions|69.33|||<|0.001|TWO_SIDED|95.0|53.33|85.33||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||180 minutes||85.33|53.33|<0.001
72554089|NCT00913627|144640407|SUPERIORITY_OR_OTHER||CMH adjusted proportions|77.82|||<|0.001|TWO_SIDED|95.0|63.57|92.06||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||180 minutes||92.06|63.57|<0.001
72554090|NCT00913627|144640407|SUPERIORITY_OR_OTHER||CMH adjusted proportions|58.86|||<|0.001|TWO_SIDED|95.0|41.88|75.84||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||180 minutes||75.84|41.88|<0.001
72554091|NCT00913627|144640407|SUPERIORITY_OR_OTHER||CMH adjusted proportions|69.33|||<|0.001|TWO_SIDED|95.0|53.33|85.33||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||240 minutes||85.33|53.33|<0.001
72371322|NCT02712047|144252883|OTHER||Mean Difference (Net)|0.04|||||TWO_SIDED|95.0|-0.06|0.14|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 7, AM|||0.14|-0.06|
72554092|NCT00913627|144640407|SUPERIORITY_OR_OTHER||CMH adjusted proportions|77.82|||<|0.001|TWO_SIDED|95.0|63.57|92.06||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||240 minutes||92.06|63.57|<0.001
72554093|NCT00913627|144640407|SUPERIORITY_OR_OTHER||CMH adjusted proportions|58.86|||<|0.001|TWO_SIDED|95.0|41.88|75.84||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||240 minutes||75.84|41.88|<0.001
72554094|NCT00913627|144640407|SUPERIORITY_OR_OTHER||CMH adjusted proportions|69.33|||<|0.001|TWO_SIDED|95.0|53.33|85.33||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||300 minutes||85.33|53.33|<0.001
72554095|NCT00913627|144640407|SUPERIORITY_OR_OTHER||CMH adjusted proportions|77.82|||<|0.001|TWO_SIDED|95.0|63.57|92.06||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||300 minutes||92.06|63.57|<0.001
72554096|NCT00913627|144640407|SUPERIORITY_OR_OTHER||CMH adjusted proportions|58.86|||<|0.001|TWO_SIDED|95.0|41.88|75.84||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||300 minutes||75.84|41.88|<0.001
72554097|NCT00913627|144640407|SUPERIORITY_OR_OTHER||CMH adjusted proportions|69.33|||<|0.001|TWO_SIDED|95.0|53.33|85.33||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||360 minutes||85.33|53.33|<0.001
72554098|NCT00913627|144640407|SUPERIORITY_OR_OTHER||CMH adjusted proportions|77.82|||<|0.001|TWO_SIDED|95.0|63.57|92.06||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||360 minutes||92.06|63.57|<0.001
72554099|NCT00913627|144640407|SUPERIORITY_OR_OTHER||CMH adjusted proportions|58.86|||<|0.001|TWO_SIDED|95.0|41.88|75.84||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||360 minutes||75.84|41.88|<0.001
72554100|NCT00913627|144640408|SUPERIORITY_OR_OTHER||Hazard Ratio, log|13.56|||<|0.001|TWO_SIDED|95.0|4.85|37.89||p-value adjusted for gender and categorical baseline pain severity|Proportional hazards regression|||||37.89|4.85|<0.001
72554101|NCT00913627|144640409|SUPERIORITY_OR_OTHER||CMH adjusted proportions|2.03||||0.434|TWO_SIDED|95.0|-1.95|6.02||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||15 minutes||6.02|-1.95|0.434
72554102|NCT00913627|144640409|SUPERIORITY_OR_OTHER||CMH adjusted proportions|0.0|||||TWO_SIDED|95.0|0.0|0.0|||Cochran-Mantel-Haenszel|||15 minutes||0.00|0.00|
72554103|NCT00913627|144640409|SUPERIORITY_OR_OTHER||CMH adjusted proportions|1.78||||0.469|TWO_SIDED|95.0|-1.71|5.27||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||15 minutes||5.27|-1.71|0.469
72554104|NCT00913627|144640409|SUPERIORITY_OR_OTHER||CMH adjusted proportions|9.13||||0.101|TWO_SIDED|95.0|1.33|16.93||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||30 minutes||16.93|1.33|0.101
72554105|NCT00913627|144640409|SUPERIORITY_OR_OTHER||CMH adjusted proportions|10.73||||0.069|TWO_SIDED|95.0|2.54|18.91||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||30 minutes||18.91|2.54|0.069
72554106|NCT00913627|144640409|SUPERIORITY_OR_OTHER||CMH adjusted proportions|3.59||||0.303|TWO_SIDED|95.0|-1.39|8.57||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||30 minutes||8.57|-1.39|0.303
72554107|NCT00913627|144640409|SUPERIORITY_OR_OTHER||CMH adjusted proportions|24.58||||0.008|TWO_SIDED|95.0|10.68|38.47||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||45 minutes||38.47|10.68|0.008
72554108|NCT00913627|144640409|SUPERIORITY_OR_OTHER||CMH adjusted proportions|25.31||||0.007|TWO_SIDED|95.0|11.35|39.28||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||45 minutes||39.28|11.35|0.007
72554109|NCT00913627|144640409|SUPERIORITY_OR_OTHER||CMH adjusted proportions|10.62||||0.129|TWO_SIDED|95.0|-0.68|21.92||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||45 minutes||21.92|-0.68|0.129
72371323|NCT02712047|144252883|OTHER||Mean Difference (Net)|0.03|||||TWO_SIDED|95.0|-0.07|0.13|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 21, AM|||0.13|-0.07|
72554110|NCT00913627|144640409|SUPERIORITY_OR_OTHER||CMH adjusted proportions|47.72|||<|0.001|TWO_SIDED|95.0|32.25|63.19||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||60 minutes||63.19|32.25|<0.001
72554111|NCT00913627|144640409|SUPERIORITY_OR_OTHER||CMH adjusted proportions|36.01|||<|0.001|TWO_SIDED|95.0|21.24|50.78||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||60 minutes||50.78|21.24|<0.001
72554112|NCT00913627|144640409|SUPERIORITY_OR_OTHER||CMH adjusted proportions|27.87||||0.003|TWO_SIDED|95.0|13.93|41.81||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||60 minutes||41.81|13.93|0.003
72554113|NCT00913627|144640409|SUPERIORITY_OR_OTHER||CMH adjusted proportions|61.01|||<|0.001|TWO_SIDED|95.0|46.12|75.89||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||90 minutes||75.89|46.12|<0.001
72554114|NCT00913627|144640409|SUPERIORITY_OR_OTHER||CMH adjusted proportions|53.83|||<|0.001|TWO_SIDED|95.0|38.85|68.8||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||90 minutes||68.80|38.85|<0.001
72554115|NCT00913627|144640409|SUPERIORITY_OR_OTHER||CMH adjusted proportions|46.74|||<|0.001|TWO_SIDED|95.0|31.89|61.58||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||90 minutes||61.58|31.89|<0.001
72554116|NCT00913627|144640409|SUPERIORITY_OR_OTHER||CMH adjusted proportions|64.78|||<|0.001|TWO_SIDED|95.0|49.37|80.18||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||120 minutes||80.18|49.37|<0.001
72554117|NCT00913627|144640409|SUPERIORITY_OR_OTHER||CMH adjusted proportions|64.8|||<|0.001|TWO_SIDED|95.0|50.01|79.59||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||120 minutes||79.59|50.01|<0.001
72554118|NCT00913627|144640409|SUPERIORITY_OR_OTHER||CMH adjusted proportions|50.19|||<|0.001|TWO_SIDED|95.0|34.27|66.11||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||120 minutes||66.11|34.27|<0.001
72554119|NCT00913627|144640409|SUPERIORITY_OR_OTHER||CMH adjusted proportions|68.59|||<|0.001|TWO_SIDED|95.0|52.81|84.38||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||180 minutes||84.38|52.81|<0.001
72554120|NCT00913627|144640409|SUPERIORITY_OR_OTHER||CMH adjusted proportions|72.16|||<|0.001|TWO_SIDED|95.0|57.05|87.26||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||180 minutes||87.26|57.05|<0.001
72554121|NCT00913627|144640409|SUPERIORITY_OR_OTHER||CMH adjusted proportions|53.47|||<|0.001|TWO_SIDED|95.0|36.57|70.37||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||180 minutes||70.37|36.57|<0.001
72371324|NCT03036215|144252887|OTHER||Mean Difference (Net)|-7.0|||||TWO_SIDED|||||||||Pilot study, no power analysis applicable; no statistical test||||
72554122|NCT00913627|144640409|SUPERIORITY_OR_OTHER||CMH adjusted proportions|72.66|||<|0.001|TWO_SIDED|95.0|57.48|87.84||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||240 minutes||87.84|57.48|<0.001
72371325|NCT03036215|144252888|OTHER|pilot study; no statistical test performed|Mean Difference (Net)|1.0|||||TWO_SIDED|||||||||Pilot study; no statistical test run||||
72371326|NCT03036215|144252889|OTHER||Mean Difference (Net)|-5.2|||||TWO_SIDED|||||||||Pilot study; no statistical test for significance run||||
72554123|NCT00913627|144640409|SUPERIORITY_OR_OTHER||CMH adjusted proportions|79.36|||<|0.001|TWO_SIDED|95.0|65.68|93.05||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||240 minutes||93.05|65.68|<0.001
72554124|NCT00913627|144640409|SUPERIORITY_OR_OTHER||CMH adjusted proportions|57.03|||<|0.001|TWO_SIDED|95.0|40.46|73.6||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||240 minutes||73.60|40.46|<0.001
72554125|NCT00913627|144640409|SUPERIORITY_OR_OTHER||CMH adjusted proportions|72.66|||<|0.001|TWO_SIDED|95.0|57.48|87.84||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||300 minutes||87.84|57.48|<0.001
72554126|NCT00913627|144640409|SUPERIORITY_OR_OTHER||CMH adjusted proportions|81.2|||<|0.001|TWO_SIDED|95.0|67.91|94.49||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||300 minutes||94.49|67.91|<0.001
72554127|NCT00913627|144640409|SUPERIORITY_OR_OTHER||CMH adjusted proportions|58.84|||<|0.001|TWO_SIDED|95.0|42.34|75.35||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||300 minutes||75.35|42.34|<0.001
72554128|NCT00913627|144640409|SUPERIORITY_OR_OTHER||CMH adjusted proportions|69.33|||<|0.001|TWO_SIDED|95.0|53.33|85.33||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||360 minutes||85.33|53.33|<0.001
72554129|NCT00913627|144640409|SUPERIORITY_OR_OTHER||CMH adjusted proportions|77.82|||<|0.001|TWO_SIDED|95.0|63.57|92.06||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||360 minutes||92.06|63.57|<0.001
72554130|NCT00913627|144640409|SUPERIORITY_OR_OTHER||CMH adjusted proportions|58.86|||<|0.001|TWO_SIDED|95.0|41.88|75.84||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||360 minutes||75.84|41.88|<0.001
72554131|NCT00913627|144640410|SUPERIORITY_OR_OTHER||Goodman-Kruskal Gamma Statistic|0.93|||<|0.001|TWO_SIDED|95.0|0.85|1.01||p-value from CMH test with modified ridit scores, adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||||1.01|0.85|<0.001
72554132|NCT00913627|144640410|SUPERIORITY_OR_OTHER||Goodman-Kruskal Gamma Statistic|0.95|||<|0.001|TWO_SIDED|95.0|0.88|1.02||p-value from CMH test with modified ridit scores, adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||||1.02|0.88|<0.001
72554133|NCT00913627|144640410|SUPERIORITY_OR_OTHER||Goodman-Kruskal Gamma Statistic|0.84|||<|0.001|TWO_SIDED|95.0|0.7|0.98||p-value from CMH test with modified ridit scores, adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||||0.98|0.70|<0.001
72554134|NCT00913627|144640411|SUPERIORITY_OR_OTHER||Goodman-Kruskal Gamma Statistic|0.93|||<|0.001|TWO_SIDED|95.0|0.85|1.01||p-value from CMH test with modified ridit scores, adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||||1.01|0.85|<0.001
72554135|NCT00913627|144640411|SUPERIORITY_OR_OTHER||Goodman-Kruskal Gamma Statistic|0.96|||<|0.001|TWO_SIDED|95.0|0.91|1.01||p-value from CMH test with modified ridit scores, adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||||1.01|0.91|<0.001
72554136|NCT00913627|144640411|SUPERIORITY_OR_OTHER||Goodman-Kruskal Gamma Statistic|0.89|||<|0.001|TWO_SIDED|95.0|0.79|0.99||p-value from CMH test with modified ridit scores, adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||||0.99|0.79|<0.001
72554137|NCT00913627|144640412|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.22||||0.008|TWO_SIDED|95.0|0.06|0.38||p-value adjusted for baseline PSR and gender|ANOVA|||15 minutes||0.38|0.06|0.008
72554138|NCT00913627|144640412|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.22||||0.007|TWO_SIDED|95.0|0.06|0.38||p-value adjusted for baseline PSR and gender|ANOVA|||15 minutes||0.38|0.06|0.007
72554139|NCT00913627|144640412|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.18||||0.024|TWO_SIDED|95.0|0.02|0.34||p-value adjusted for baseline PSR and gender|ANOVA|||15 minutes||0.34|0.02|0.024
72554140|NCT00913627|144640412|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.51|||<|0.001|TWO_SIDED|95.0|0.24|0.78||p-value adjusted for baseline PSR and gender|ANOVA|||30 minutes||0.78|0.24|<0.001
72554141|NCT00913627|144640412|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.47|||<|0.001|TWO_SIDED|95.0|0.2|0.73||p-value adjusted for baseline PSR and gender|ANOVA|||30 minutes||0.73|0.20|<0.001
72554142|NCT00913627|144640412|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.42||||0.002|TWO_SIDED|95.0|0.16|0.68||p-value adjusted for baseline PSR and gender|ANOVA|||30 minutes||0.68|0.16|0.002
72554143|NCT00913627|144640412|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.85|||<|0.001|TWO_SIDED|95.0|0.52|1.17||p-value adjusted for baseline PSR and gender|ANOVA|||45 minutes||1.17|0.52|<0.001
72554144|NCT00913627|144640412|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.79|||<|0.001|TWO_SIDED|95.0|0.47|1.11||p-value adjusted for baseline PSR and gender|ANOVA|||45 minutes||1.11|0.47|<0.001
72554145|NCT00913627|144640412|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.62|||<|0.001|TWO_SIDED|95.0|0.3|0.94||p-value adjusted for baseline PSR and gender|ANOVA|||45 minutes||0.94|0.30|<0.001
72554146|NCT00913627|144640412|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.01|||<|0.001|TWO_SIDED|95.0|0.65|1.37||p-value adjusted for baseline PSR and gender|ANOVA|||60 minutes||1.37|0.65|<0.001
72554147|NCT00913627|144640412|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.09|||<|0.001|TWO_SIDED|95.0|0.73|1.44||p-value adjusted for baseline PSR and gender|ANOVA|||60 minutes||1.44|0.73|<0.001
72554148|NCT00913627|144640412|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.9|||<|0.001|TWO_SIDED|95.0|0.54|1.25||p-value adjusted for baseline PSR and gender|ANOVA|||60 minutes||1.25|0.54|<0.001
72554149|NCT00913627|144640412|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.26|||<|0.001|TWO_SIDED|95.0|0.9|1.63||p-value adjusted for baseline PSR and gender|ANOVA|||90 minutes||1.63|0.90|<0.001
72554150|NCT00913627|144640412|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.33|||<|0.001|TWO_SIDED|95.0|0.97|1.69||p-value adjusted for baseline PSR and gender|ANOVA|||90 minutes||1.69|0.97|<0.001
72371327|NCT00843284|144252897|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-4.16|STANDARD_DEVIATION|2.52|<|0.0001||95.0|-4.35|-3.97|||t-test, 2 sided|One sample t-test||Change from Baseline; observational study||-3.97|-4.35|<0.0001
72554151|NCT00913627|144640412|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.1|||<|0.001|TWO_SIDED|95.0|0.74|1.45||p-value adjusted for baseline PSR and gender|ANOVA|||90 minutes||1.45|0.74|<0.001
72554152|NCT00913627|144640412|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.45|||<|0.001|TWO_SIDED|95.0|1.09|1.82||p-value adjusted for baseline PSR and gender|ANOVA|||2 hours||1.82|1.09|<0.001
72554153|NCT00913627|144640412|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.46|||<|0.001|TWO_SIDED|95.0|1.1|1.82||p-value adjusted for baseline PSR and gender|ANOVA|||2 hours||1.82|1.10|<0.001
72554154|NCT00913627|144640412|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.03|||<|0.001|TWO_SIDED|95.0|0.67|1.38||p-value adjusted for baseline PSR and gender|ANOVA|||2 hours||1.38|0.67|<0.001
72554155|NCT00913627|144640412|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.63|||<|0.001|TWO_SIDED|95.0|1.26|2.0||p-value adjusted for baseline PSR and gender|ANOVA|||3 hours||2.00|1.26|<0.001
72554156|NCT00913627|144640412|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.61|||<|0.001|TWO_SIDED|95.0|1.25|1.98||p-value adjusted for baseline PSR and gender|ANOVA|||3 hours||1.98|1.25|<0.001
72554157|NCT00913627|144640412|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.21|||<|0.001|TWO_SIDED|95.0|0.85|1.57||p-value adjusted for baseline PSR and gender|ANOVA|||3 hours||1.57|0.85|<0.001
72371328|NCT00843284|144252898|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-4.02|STANDARD_DEVIATION|2.9|<|0.0001||95.0|-4.24|-3.8|||t-test, 2 sided|One sample t-test.||Change from baseline||-3.80|-4.24|<0.0001
72554158|NCT00913627|144640412|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.71|||<|0.001|TWO_SIDED|95.0|1.33|2.08||p-value adjusted for baseline PSR and gender|ANOVA|||4 hours||2.08|1.33|<0.001
72554159|NCT00913627|144640412|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.6|||<|0.001|TWO_SIDED|95.0|1.23|1.97||p-value adjusted for baseline PSR and gender|ANOVA|||4 hours||1.97|1.23|<0.001
72554160|NCT00913627|144640412|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.17|||<|0.001|TWO_SIDED|95.0|0.81|1.54||p-value adjusted for baseline PSR and gender|ANOVA|||4 hours||1.54|0.81|<0.001
72554161|NCT00913627|144640412|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.6|||<|0.001|TWO_SIDED|95.0|1.2|2.0||p-value adjusted for baseline PSR and gender|ANOVA|||5 hours||2.00|1.20|<0.001
72554162|NCT00913627|144640412|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.58|||<|0.001|TWO_SIDED|95.0|1.19|1.98||p-value adjusted for baseline PSR and gender|ANOVA|||5 hours||1.98|1.19|<0.001
72554163|NCT00913627|144640412|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.12|||<|0.001|TWO_SIDED|95.0|0.73|1.52||p-value adjusted for baseline PSR and gender|ANOVA|||5 hours||1.52|0.73|<0.001
72554164|NCT00913627|144640412|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.49|||<|0.001|TWO_SIDED|95.0|1.08|1.9||p-value adjusted for baseline PSR and gender|ANOVA|||6 hours||1.90|1.08|<0.001
72554165|NCT00913627|144640412|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.56|||<|0.001|TWO_SIDED|95.0|1.16|1.97||p-value adjusted for baseline PSR and gender|ANOVA|||6 hours||1.97|1.16|<0.001
72554166|NCT00913627|144640412|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.13|||<|0.001|TWO_SIDED|95.0|0.72|1.53||p-value adjusted for baseline PSR and gender|ANOVA|||6 hours||1.53|0.72|<0.001
72554167|NCT00913627|144640412|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.38|||<|0.001|TWO_SIDED|95.0|0.97|1.79||p-value adjusted for baseline PSR and gender|ANOVA|||7 hours||1.79|0.97|<0.001
72554168|NCT00913627|144640412|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.55|||<|0.001|TWO_SIDED|95.0|1.14|1.95||p-value adjusted for baseline PSR and gender|ANOVA|||7 hours||1.95|1.14|<0.001
72554169|NCT00913627|144640412|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.02|||<|0.001|TWO_SIDED|95.0|0.62|1.43||p-value adjusted for baseline PSR and gender|ANOVA|||7 hours||1.43|0.62|<0.001
72554170|NCT00913627|144640412|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.35|||<|0.001|TWO_SIDED|95.0|0.93|1.77||p-value adjusted for baseline PSR and gender|ANOVA|||8 hours||1.77|0.93|<0.001
72554171|NCT00913627|144640412|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.39|||<|0.001|TWO_SIDED|95.0|0.97|1.81||p-value adjusted for baseline PSR and gender|ANOVA|||8 hours||1.81|0.97|<0.001
72554172|NCT00913627|144640412|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.04|||<|0.001|TWO_SIDED|95.0|0.63|1.46||p-value adjusted for baseline PSR and gender|ANOVA|||8 hours||1.46|0.63|<0.001
72554173|NCT00913627|144640412|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.29|||<|0.001|TWO_SIDED|95.0|0.87|1.71||p-value adjusted for baseline PSR and gender|ANOVA|||9 hours||1.71|0.87|<0.001
72554174|NCT00913627|144640412|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.39|||<|0.001|TWO_SIDED|95.0|0.97|1.81||p-value adjusted for baseline PSR and gender|ANOVA|||9 hours||1.81|0.97|<0.001
72554175|NCT00913627|144640412|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.98|||<|0.001|TWO_SIDED|95.0|0.56|1.39||p-value adjusted for baseline PSR and gender|ANOVA|||9 hours||1.39|0.56|<0.001
72554176|NCT00913627|144640412|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.25|||<|0.001|TWO_SIDED|95.0|0.82|1.68||p-value adjusted for baseline PSR and gender|ANOVA|||10 hours||1.68|0.82|<0.001
72554177|NCT00913627|144640412|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.46|||<|0.001|TWO_SIDED|95.0|1.03|1.89||p-value adjusted for baseline PSR and gender|ANOVA|||10 hours||1.89|1.03|<0.001
72554178|NCT00913627|144640412|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.03|||<|0.001|TWO_SIDED|95.0|0.6|1.45||p-value adjusted for baseline PSR and gender|ANOVA|||10 hours||1.45|0.60|<0.001
72554179|NCT00913627|144640412|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.21|||<|0.001|TWO_SIDED|95.0|0.77|1.64||p-value adjusted for baseline PSR and gender|ANOVA|||11 hours||1.64|0.77|<0.001
72554180|NCT00913627|144640412|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.44|||<|0.001|TWO_SIDED|95.0|1.0|1.87||p-value adjusted for baseline PSR and gender|ANOVA|||11 hours||1.87|1.00|<0.001
72554181|NCT00913627|144640412|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.04|||<|0.001|TWO_SIDED|95.0|0.61|1.48||p-value adjusted for baseline PSR and gender|ANOVA|||11 hours||1.48|0.61|<0.001
72554182|NCT00913627|144640412|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.25|||<|0.001|TWO_SIDED|95.0|0.81|1.68||p-value adjusted for baseline PSR and gender|ANOVA|||12 hours||1.68|0.81|<0.001
72622155|NCT04003142|144774326|SUPERIORITY||Odds Ratio (OR)|2.087||||0.086||95.0|0.923|5.043||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 7||5.043|0.923|0.086
72554183|NCT00913627|144640412|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.39|||<|0.001|TWO_SIDED|95.0|0.96|1.82||p-value adjusted for baseline PSR and gender|ANOVA|||12 hours||1.82|0.96|<0.001
72554184|NCT00913627|144640412|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.96|||<|0.001|TWO_SIDED|95.0|0.53|1.39||p-value adjusted for baseline PSR and gender|ANOVA|||12 hours||1.39|0.53|<0.001
72554185|NCT00913627|144640412|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.2|||<|0.001|TWO_SIDED|95.0|0.75|1.64||p-value adjusted for baseline PSR and gender|ANOVA|||13 hours||1.64|0.75|<0.001
72554186|NCT00913627|144640412|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.21|||<|0.001|TWO_SIDED|95.0|0.77|1.65||p-value adjusted for baseline PSR and gender|ANOVA|||13 hours||1.65|0.77|<0.001
72554187|NCT00913627|144640412|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.93|||<|0.001|TWO_SIDED|95.0|0.49|1.36||p-value adjusted for baseline PSR and gender|ANOVA|||13 hours||1.36|0.49|<0.001
72554188|NCT00913627|144640412|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.07|||<|0.001|TWO_SIDED|95.0|0.6|1.53||p-value adjusted for baseline PSR and gender|ANOVA|||14 hours||1.53|0.60|<0.001
72554189|NCT00913627|144640412|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.12|||<|0.001|TWO_SIDED|95.0|0.66|1.58||p-value adjusted for baseline PSR and gender|ANOVA|||14 hours||1.58|0.66|<0.001
72554190|NCT00913627|144640412|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.87|||<|0.001|TWO_SIDED|95.0|0.42|1.33||p-value adjusted for baseline PSR and gender|ANOVA|||14 hours||1.33|0.42|<0.001
72554191|NCT00913627|144640412|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.06|||<|0.001|TWO_SIDED|95.0|0.61|1.51||p-value adjusted for baseline PSR and gender|ANOVA|||16 hours||1.51|0.61|<0.001
72554192|NCT00913627|144640412|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.03|||<|0.001|TWO_SIDED|95.0|0.58|1.48||p-value adjusted for baseline PSR and gender|ANOVA|||16 hours||1.48|0.58|<0.001
72554193|NCT00913627|144640412|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.96|||<|0.001|TWO_SIDED|95.0|0.52|1.4||p-value adjusted for baseline PSR and gender|ANOVA|||16 hours||1.40|0.52|<0.001
72554194|NCT00913627|144640412|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.77||||0.001|TWO_SIDED|95.0|0.31|1.24||p-value adjusted for baseline PSR and gender|ANOVA|||24 hours||1.24|0.31|0.001
72554195|NCT00913627|144640412|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.82|||<|0.001|TWO_SIDED|95.0|0.36|1.28||p-value adjusted for baseline PSR and gender|ANOVA|||24 hours||1.28|0.36|<0.001
72371329|NCT00147069|144252901|SUPERIORITY|||||||0.1|||||||Kruskal-Wallis|||||||0.1
72554196|NCT00913627|144640412|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.88|||<|0.001|TWO_SIDED|95.0|0.42|1.33||p-value adjusted for baseline PSR and gender|ANOVA|||24 hours||1.33|0.42|<0.001
72554197|NCT00913627|144640413|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.29||||0.034|TWO_SIDED|95.0|0.02|0.57||p-value adjusted for baseline PSR and gender|ANOVA|||15 minutes||0.57|0.02|0.034
72554198|NCT00913627|144640413|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.22||||0.111|TWO_SIDED|95.0|-0.05|0.49||p-value adjusted for baseline PSR and gender|ANOVA|||15 minutes||0.49|-0.05|0.111
72554199|NCT00913627|144640413|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.21||||0.125|TWO_SIDED|95.0|-0.06|0.48||p-value adjusted for baseline PSR and gender|ANOVA|||15 minutes||0.48|-0.06|0.125
72554200|NCT00913627|144640413|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.81|||<|0.001|TWO_SIDED|95.0|0.41|1.22||p-value adjusted for baseline PSR and gender|ANOVA|||30 minutes||1.22|0.41|<0.001
72554201|NCT00913627|144640413|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.61||||0.003|TWO_SIDED|95.0|0.22|1.01||p-value adjusted for baseline PSR and gender|ANOVA|||30 minutes||1.01|0.22|0.003
72554202|NCT00913627|144640413|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.59||||0.004|TWO_SIDED|95.0|0.19|0.98||p-value adjusted for baseline PSR and gender|ANOVA|||30 minutes||0.98|0.19|0.004
72554203|NCT00913627|144640413|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.41|||<|0.001|TWO_SIDED|95.0|0.91|1.91||p-value adjusted for baseline PSR and gender|ANOVA|||45 minutes||1.91|0.91|<0.001
72554204|NCT00913627|144640413|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.24|||<|0.001|TWO_SIDED|95.0|0.75|1.74||p-value adjusted for baseline PSR and gender|ANOVA|||45 minutes||1.74|0.75|<0.001
72554205|NCT00913627|144640413|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.9|||<|0.001|TWO_SIDED|95.0|0.41|1.39||p-value adjusted for baseline PSR and gender|ANOVA|||45 minutes||1.39|0.41|<0.001
72554206|NCT00913627|144640413|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.63|||<|0.001|TWO_SIDED|95.0|1.11|2.16||p-value adjusted for baseline PSR and gender|ANOVA|||60 minutes||2.16|1.11|<0.001
72554207|NCT00913627|144640413|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.57|||<|0.001|TWO_SIDED|95.0|1.05|2.09||p-value adjusted for baseline PSR and gender|ANOVA|||60 minutes||2.09|1.05|<0.001
72554208|NCT00913627|144640413|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.26|||<|0.001|TWO_SIDED|95.0|0.75|1.78||p-value adjusted for baseline PSR and gender|ANOVA|||60 minutes||1.78|0.75|<0.001
72554209|NCT00913627|144640413|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.99|||<|0.001|TWO_SIDED|95.0|1.46|2.52||p-value adjusted for baseline PSR and gender|ANOVA|||90 minutes||2.52|1.46|<0.001
72554210|NCT00913627|144640413|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.09|||<|0.001|TWO_SIDED|95.0|1.57|2.61||p-value adjusted for baseline PSR and gender|ANOVA|||90 minutes||2.61|1.57|<0.001
72554211|NCT00913627|144640413|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.68|||<|0.001|TWO_SIDED|95.0|1.16|2.2||p-value adjusted for baseline PSR and gender|ANOVA|||90 minutes||2.20|1.16|<0.001
72614881|NCT03086343|144759873|NON_INFERIORITY|The non-inferiority of upadacitinib 15 mg versus abatacept was tested using the 95% confidence interval (CI) of treatment difference against a non-inferiority margin of 0.6.|LS Mean Difference|-0.52|||<|0.001|TWO_SIDED|95.0|-0.69|-0.35||The ANCOVA model included treatment as the fixed factor; corresponding baseline value and the stratification factor of prior bDMARD used as covariates.|ANCOVA||Treatment Difference = Upadacitinib 15 mg - Abatacept|In order to preserve Type I error, a step-down approach was used to test the primary and ranked secondary endpoints in a pre-specified order where statistical significance at the 0.05 level could be claimed for a lower ranked endpoint only if the previous endpoint in the sequence met the requirements of significance.||-0.35|-0.69|< 0.001
72554212|NCT00913627|144640413|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.12|||<|0.001|TWO_SIDED|95.0|1.59|2.64||p-value adjusted for baseline PSR and gender|ANOVA|||2 hours||2.64|1.59|<0.001
72554213|NCT00913627|144640413|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.22|||<|0.001|TWO_SIDED|95.0|1.7|2.74||p-value adjusted for baseline PSR and gender|ANOVA|||2 hours||2.74|1.70|<0.001
72622156|NCT04003142|144774326|SUPERIORITY||Odds Ratio (OR)|1.774||||0.168||95.0|0.798|4.143||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 8||4.143|0.798|0.168
72554214|NCT00913627|144640413|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.69|||<|0.001|TWO_SIDED|95.0|1.18|2.21||p-value adjusted for baseline PSR and gender|ANOVA|||2 hours||2.21|1.18|<0.001
72554215|NCT00913627|144640413|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.5|||<|0.001|TWO_SIDED|95.0|1.98|3.01||p-value adjusted for baseline PSR and gender|ANOVA|||3 hours||3.01|1.98|<0.001
72554216|NCT00913627|144640413|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.48|||<|0.001|TWO_SIDED|95.0|1.97|2.99||p-value adjusted for baseline PSR and gender|ANOVA|||3 hours||2.99|1.97|<0.001
72554217|NCT00913627|144640413|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.88|||<|0.001|TWO_SIDED|95.0|1.37|2.38||p-value adjusted for baseline PSR and gender|ANOVA|||3 hours||2.38|1.37|<0.001
72554218|NCT00913627|144640413|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.54|||<|0.001|TWO_SIDED|95.0|2.01|3.07||p-value adjusted for baseline PSR and gender|ANOVA|||4 hours||3.07|2.01|<0.001
72554219|NCT00913627|144640413|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.45|||<|0.001|TWO_SIDED|95.0|1.92|2.97||p-value adjusted for baseline PSR and gender|ANOVA|||4 hours||2.97|1.92|<0.001
72554220|NCT00913627|144640413|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.81|||<|0.001|TWO_SIDED|95.0|1.29|2.33||p-value adjusted for baseline PSR and gender|ANOVA|||4 hours||2.33|1.29|<0.001
72554221|NCT00913627|144640413|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.47|||<|0.001|TWO_SIDED|95.0|1.92|3.03||p-value adjusted for baseline PSR and gender|ANOVA|||5 hours||3.03|1.92|<0.001
72554222|NCT00913627|144640413|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.41|||<|0.001|TWO_SIDED|95.0|1.87|2.96||p-value adjusted for baseline PSR and gender|ANOVA|||5 hours||2.96|1.87|<0.001
72554223|NCT00913627|144640413|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.71|||<|0.001|TWO_SIDED|95.0|1.16|2.25||p-value adjusted for baseline PSR and gender|ANOVA|||5 hours||2.25|1.16|<0.001
72554224|NCT00913627|144640413|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.26|||<|0.001|TWO_SIDED|95.0|1.69|2.83||p-value adjusted for baseline PSR and gender|ANOVA|||6 hours||2.83|1.69|<0.001
72554225|NCT00913627|144640413|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.37|||<|0.001|TWO_SIDED|95.0|1.8|2.93||p-value adjusted for baseline PSR and gender|ANOVA|||6 hours||2.93|1.80|<0.001
72554226|NCT00913627|144640413|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.67|||<|0.001|TWO_SIDED|95.0|1.11|2.23||p-value adjusted for baseline PSR and gender|ANOVA|||6 hours||2.23|1.11|<0.001
72554227|NCT00913627|144640413|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.22|||<|0.001|TWO_SIDED|95.0|1.66|2.79||p-value adjusted for baseline PSR and gender|ANOVA|||7 hours||2.79|1.66|<0.001
72554228|NCT00913627|144640413|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.3|||<|0.001|TWO_SIDED|95.0|1.74|2.85||p-value adjusted for baseline PSR and gender|ANOVA|||7 hours||2.85|1.74|<0.001
72554229|NCT00913627|144640413|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.57|||<|0.001|TWO_SIDED|95.0|1.02|2.13||p-value adjusted for baseline PSR and gender|ANOVA|||7 hours||2.13|1.02|<0.001
72622157|NCT04003142|144774326|SUPERIORITY||Odds Ratio (OR)|2.374||||0.03||95.0|1.112|5.41||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 8||5.410|1.112|0.030
72554230|NCT00913627|144640413|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.19|||<|0.001|TWO_SIDED|95.0|1.59|2.78||p-value adjusted for baseline PSR and gender|ANOVA|||8 hours||2.78|1.59|<0.001
72554231|NCT00913627|144640413|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.12|||<|0.001|TWO_SIDED|95.0|1.53|2.7||p-value adjusted for baseline PSR and gender|ANOVA|||8 hours||2.70|1.53|<0.001
72554232|NCT00913627|144640413|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.63|||<|0.001|TWO_SIDED|95.0|1.04|2.21||p-value adjusted for baseline PSR and gender|ANOVA|||8 hours||2.21|1.04|<0.001
72554233|NCT00913627|144640413|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.91|||<|0.001|TWO_SIDED|95.0|1.3|2.52||p-value adjusted for baseline PSR and gender|ANOVA|||9 hours||2.52|1.30|<0.001
72554234|NCT00913627|144640413|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.12|||<|0.001|TWO_SIDED|95.0|1.52|2.72||p-value adjusted for baseline PSR and gender|ANOVA|||9 hours||2.72|1.52|<0.001
72554235|NCT00913627|144640413|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.51|||<|0.001|TWO_SIDED|95.0|0.91|2.11||p-value adjusted for baseline PSR and gender|ANOVA|||9 hours||2.11|0.91|<0.001
72554236|NCT00913627|144640413|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.94|||<|0.001|TWO_SIDED|95.0|1.34|2.55||p-value adjusted for baseline PSR and gender|ANOVA|||10 hours||2.55|1.34|<0.001
72554237|NCT00913627|144640413|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.19|||<|0.001|TWO_SIDED|95.0|1.59|2.79||p-value adjusted for baseline PSR and gender|ANOVA|||10 hours||2.79|1.59|<0.001
72554238|NCT00913627|144640413|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.56|||<|0.001|TWO_SIDED|95.0|0.97|2.16||p-value adjusted for baseline PSR and gender|ANOVA|||10 hours||2.16|0.97|<0.001
72554239|NCT00913627|144640413|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.9|||<|0.001|TWO_SIDED|95.0|1.28|2.52||p-value adjusted for baseline PSR and gender|ANOVA|||11 hours||2.52|1.28|<0.001
72554240|NCT00913627|144640413|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.13|||<|0.001|TWO_SIDED|95.0|1.52|2.75||p-value adjusted for baseline PSR and gender|ANOVA|||11 hours||2.75|1.52|<0.001
72554241|NCT00913627|144640413|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.59|||<|0.001|TWO_SIDED|95.0|0.98|2.2||p-value adjusted for baseline PSR and gender|ANOVA|||11 hours||2.20|0.98|<0.001
72554242|NCT00913627|144640413|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.9|||<|0.001|TWO_SIDED|95.0|1.26|2.54||p-value adjusted for baseline PSR and gender|ANOVA|||12 hours||2.54|1.26|<0.001
72554243|NCT00913627|144640413|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.03|||<|0.001|TWO_SIDED|95.0|1.39|2.66||p-value adjusted for baseline PSR and gender|ANOVA|||12 hours||2.66|1.39|<0.001
72554244|NCT00913627|144640413|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.44|||<|0.001|TWO_SIDED|95.0|0.81|2.07||p-value adjusted for baseline PSR and gender|ANOVA|||12 hours||2.07|0.81|<0.001
72554245|NCT00913627|144640413|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.83|||<|0.001|TWO_SIDED|95.0|1.17|2.49||p-value adjusted for baseline PSR and gender|ANOVA|||13 hours||2.49|1.17|<0.001
72554246|NCT00913627|144640413|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.78|||<|0.001|TWO_SIDED|95.0|1.13|2.43||p-value adjusted for baseline PSR and gender|ANOVA|||13 hours||2.43|1.13|<0.001
72371330|NCT00147069|144252902|SUPERIORITY|||||||0.05||||||The reported p value was calculated|Kruskal-Wallis|||||||0.05
72554247|NCT00913627|144640413|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.42|||<|0.001|TWO_SIDED|95.0|0.78|2.07||p-value adjusted for baseline PSR and gender|ANOVA|||13 hours||2.07|0.78|<0.001
72554248|NCT00913627|144640413|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.64|||<|0.001|TWO_SIDED|95.0|0.95|2.32||p-value adjusted for baseline PSR and gender|ANOVA|||14 hours||2.32|0.95|<0.001
72554249|NCT00913627|144640413|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.61|||<|0.001|TWO_SIDED|95.0|0.94|2.29||p-value adjusted for baseline PSR and gender|ANOVA|||14 hours||2.29|0.94|<0.001
72554250|NCT00913627|144640413|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.38|||<|0.001|TWO_SIDED|95.0|0.71|2.06||p-value adjusted for baseline PSR and gender|ANOVA|||14 hours||2.06|0.71|<0.001
72554251|NCT00913627|144640413|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.58|||<|0.001|TWO_SIDED|95.0|0.88|2.27||p-value adjusted for baseline PSR and gender|ANOVA|||16 hours||2.27|0.88|<0.001
72554252|NCT00913627|144640413|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.42|||<|0.001|TWO_SIDED|95.0|0.73|2.1||p-value adjusted for baseline PSR and gender|ANOVA|||16 hours||2.10|0.73|<0.001
72554253|NCT00913627|144640413|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.4|||<|0.001|TWO_SIDED|95.0|0.72|2.08||p-value adjusted for baseline PSR and gender|ANOVA|||16 hours||2.08|0.72|<0.001
72554254|NCT00913627|144640413|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.25|||<|0.001|TWO_SIDED|95.0|0.53|1.96||p-value adjusted for baseline PSR and gender|ANOVA|||24 hours||1.96|0.53|<0.001
72554255|NCT00913627|144640413|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.08||||0.003|TWO_SIDED|95.0|0.38|1.79||p-value adjusted for baseline PSR and gender|ANOVA|||24 hours||1.79|0.38|0.003
72554256|NCT00913627|144640413|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.32|||<|0.001|TWO_SIDED|95.0|0.61|2.02||p-value adjusted for baseline PSR and gender|ANOVA|||24 hours||2.02|0.61|<0.001
72554257|NCT00913627|144640414|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.52||||0.011|TWO_SIDED|95.0|0.12|0.91||p-value adjusted for baseline PSR and gender|ANOVA|||15 minutes||0.91|0.12|0.011
72371331|NCT00147069|144252903|SUPERIORITY|||||||0.05|||||||Kruskal-Wallis|||||||0.05
72371332|NCT00147069|144252904|SUPERIORITY|||||||0.05|||||||Kruskal-Wallis|||||||0.05
72554258|NCT00913627|144640414|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.44||||0.028|TWO_SIDED|95.0|0.05|0.83||p-value adjusted for baseline PSR and gender|ANOVA|||15 minutes||0.83|0.05|0.028
72554259|NCT00913627|144640414|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.39||||0.048|TWO_SIDED|95.0|0.0|0.78||p-value adjusted for baseline PSR and gender|ANOVA|||15 minutes||0.78|0.00|0.048
72554260|NCT00913627|144640414|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.32|||<|0.001|TWO_SIDED|95.0|0.69|1.96||p-value adjusted for baseline PSR and gender|ANOVA|||30 minutes||1.96|0.69|<0.001
72554261|NCT00913627|144640414|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.08|||<|0.001|TWO_SIDED|95.0|0.45|1.71||p-value adjusted for baseline PSR and gender|ANOVA|||30 minutes||1.71|0.45|<0.001
72554262|NCT00913627|144640414|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.01||||0.002|TWO_SIDED|95.0|0.38|1.63||p-value adjusted for baseline PSR and gender|ANOVA|||30 minutes||1.63|0.38|0.002
72554263|NCT00913627|144640414|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.26|||<|0.001|TWO_SIDED|95.0|1.46|3.06||p-value adjusted for baseline PSR and gender|ANOVA|||45 minutes||3.06|1.46|<0.001
72554264|NCT00913627|144640414|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.03|||<|0.001|TWO_SIDED|95.0|1.24|2.82||p-value adjusted for baseline PSR and gender|ANOVA|||45 minutes||2.82|1.24|<0.001
72554265|NCT00913627|144640414|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.52|||<|0.001|TWO_SIDED|95.0|0.74|2.31||p-value adjusted for baseline PSR and gender|ANOVA|||45 minutes||2.31|0.74|<0.001
72554266|NCT00913627|144640414|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.64|||<|0.001|TWO_SIDED|95.0|1.78|3.5||p-value adjusted for baseline PSR and gender|ANOVA|||60 minutes||3.50|1.78|<0.001
72554267|NCT00913627|144640414|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.66|||<|0.001|TWO_SIDED|95.0|1.81|3.51||p-value adjusted for baseline PSR and gender|ANOVA|||60 minutes||3.51|1.81|<0.001
72554268|NCT00913627|144640414|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.16|||<|0.001|TWO_SIDED|95.0|1.32|3.0||p-value adjusted for baseline PSR and gender|ANOVA|||60 minutes||3.00|1.32|<0.001
72554269|NCT00913627|144640414|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.26|||<|0.001|TWO_SIDED|95.0|2.39|4.12||p-value adjusted for baseline PSR and gender|ANOVA|||90 minutes||4.12|2.39|<0.001
72554270|NCT00913627|144640414|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.42|||<|0.001|TWO_SIDED|95.0|2.57|4.28||p-value adjusted for baseline PSR and gender|ANOVA|||90 minutes||4.28|2.57|<0.001
72554271|NCT00913627|144640414|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.77|||<|0.001|TWO_SIDED|95.0|1.92|3.63||p-value adjusted for baseline PSR and gender|ANOVA|||90 minutes||3.63|1.92|<0.001
72554272|NCT00913627|144640414|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.57|||<|0.001|TWO_SIDED|95.0|2.7|4.44||p-value adjusted for baseline PSR and gender|ANOVA|||2 hours||4.44|2.70|<0.001
72554273|NCT00913627|144640414|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.68|||<|0.001|TWO_SIDED|95.0|2.82|4.53||p-value adjusted for baseline PSR and gender|ANOVA|||2 hours||4.53|2.82|<0.001
72554274|NCT00913627|144640414|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.72|||<|0.001|TWO_SIDED|95.0|1.87|3.57||p-value adjusted for baseline PSR and gender|ANOVA|||2 hours||3.57|1.87|<0.001
72554275|NCT00913627|144640414|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.13|||<|0.001|TWO_SIDED|95.0|3.27|4.99||p-value adjusted for baseline PSR and gender|ANOVA|||3 hours||4.99|3.27|<0.001
72554276|NCT00913627|144640414|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.09|||<|0.001|TWO_SIDED|95.0|3.24|4.95||p-value adjusted for baseline PSR and gender|ANOVA|||3 hours||4.95|3.24|<0.001
72554277|NCT00913627|144640414|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.09|||<|0.001|TWO_SIDED|95.0|2.24|3.93||p-value adjusted for baseline PSR and gender|ANOVA|||3 hours||3.93|2.24|<0.001
72554278|NCT00913627|144640414|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.25|||<|0.001|TWO_SIDED|95.0|3.36|5.13||p-value adjusted for baseline PSR and gender|ANOVA|||4 hours||5.13|3.36|<0.001
72554279|NCT00913627|144640414|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.04|||<|0.001|TWO_SIDED|95.0|3.17|4.92||p-value adjusted for baseline PSR and gender|ANOVA|||4 hours||4.92|3.17|<0.001
72554280|NCT00913627|144640414|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.98|||<|0.001|TWO_SIDED|95.0|2.11|3.85||p-value adjusted for baseline PSR and gender|ANOVA|||4 hours||3.85|2.11|<0.001
72554281|NCT00913627|144640414|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.07|||<|0.001|TWO_SIDED|95.0|3.14|5.01||p-value adjusted for baseline PSR and gender|ANOVA|||5 hours||5.01|3.14|<0.001
72469424|NCT01018732|144462514|SUPERIORITY_OR_OTHER||ratio of titer|21.0|||||TWO_SIDED|95.0|12.0|36.0|||ANOVA|||Day 29, Men W-135, Pairwise comparison of geometric mean titer||36|12|
72554282|NCT00913627|144640414|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.0|||<|0.001|TWO_SIDED|95.0|3.07|4.92||p-value adjusted for baseline PSR and gender|ANOVA|||5 hours||4.92|3.07|<0.001
72554283|NCT00913627|144640414|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.83|||<|0.001|TWO_SIDED|95.0|1.91|3.75||p-value adjusted for baseline PSR and gender|ANOVA|||5 hours||3.75|1.91|<0.001
72554284|NCT00913627|144640414|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.75|||<|0.001|TWO_SIDED|95.0|2.78|4.71||p-value adjusted for baseline PSR and gender|ANOVA|||6 hours||4.71|2.78|<0.001
72554285|NCT00913627|144640414|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.93|||<|0.001|TWO_SIDED|95.0|2.98|4.89||p-value adjusted for baseline PSR and gender|ANOVA|||6 hours||4.89|2.98|<0.001
72554286|NCT00913627|144640414|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.8|||<|0.001|TWO_SIDED|95.0|1.85|3.75||p-value adjusted for baseline PSR and gender|ANOVA|||6 hours||3.75|1.85|<0.001
72554287|NCT00913627|144640414|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.61|||<|0.001|TWO_SIDED|95.0|2.65|4.56||p-value adjusted for baseline PSR and gender|ANOVA|||7 hours||4.56|2.65|<0.001
72554288|NCT00913627|144640414|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.84|||<|0.001|TWO_SIDED|95.0|2.89|4.79||p-value adjusted for baseline PSR and gender|ANOVA|||7 hours||4.79|2.89|<0.001
72469425|NCT01018732|144462514|SUPERIORITY_OR_OTHER||ratio of titer|0.9|||||TWO_SIDED|95.0|0.48|1.69|||ANOVA|||Day 1, Men Y, Pairwise comparison of geometric mean titer||1.69|0.48|
72554289|NCT00913627|144640414|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.6|||<|0.001|TWO_SIDED|95.0|1.65|3.54||p-value adjusted for baseline PSR and gender|ANOVA|||7 hours||3.54|1.65|<0.001
72554290|NCT00913627|144640414|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.54|||<|0.001|TWO_SIDED|95.0|2.54|4.53||p-value adjusted for baseline PSR and gender|ANOVA|||8 hours||4.53|2.54|<0.001
72554291|NCT00913627|144640414|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.51|||<|0.001|TWO_SIDED|95.0|2.52|4.49||p-value adjusted for baseline PSR and gender|ANOVA|||8 hours||4.49|2.52|<0.001
72554292|NCT00913627|144640414|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.67|||<|0.001|TWO_SIDED|95.0|1.69|3.65||p-value adjusted for baseline PSR and gender|ANOVA|||8 hours||3.65|1.69|<0.001
72554293|NCT00913627|144640414|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.2|||<|0.001|TWO_SIDED|95.0|2.19|4.21||p-value adjusted for baseline PSR and gender|ANOVA|||9 hours||4.21|2.19|<0.001
72614882|NCT03086343|144759874|SUPERIORITY||LS Mean Difference|-0.52|||<|0.001|TWO_SIDED|95.0|-0.69|-0.35||This comparison was a ranked secondary endpoint in the pre-specified multiplicity testing sequence.|ANCOVA|The ANCOVA model included treatment as the fixed factor; corresponding baseline value and the stratification factor of prior bDMARD used as covariates|Treatment Difference = Upadacitinib 15 mg - Abatacept|In order to preserve Type I error, a step-down approach was used to test the primary and ranked secondary endpoints in a pre specified order where statistical significance at the 0.05 level could be claimed for a lower ranked endpoint only if the previous endpoint in the sequence met the requirements of significance.||-0.35|-0.69|< 0.001
72614883|NCT03086343|144759875|SUPERIORITY||Mean Difference|16.8|||<|0.001|TWO_SIDED|95.0|10.4|23.2||This comparison was a ranked secondary endpoint in the pre-specified multiplicity testing sequence.|Cochran-Mantel-Haenszel|The stratification factor of prior failed bDMARD was used.|Treatment Difference = Upadacitinib 15 mg - Abatacept|In order to preserve Type I error, a step-down approach was used to test the primary and ranked secondary endpoints in a pre-specified order where statistical significance at the 0.05 level could be claimed for a lower ranked endpoint only if the previous endpoint in the sequence met the requirements of significance.||23.2|10.4|< 0.001
72622158|NCT04003142|144774326|SUPERIORITY||Odds Ratio (OR)|1.605||||0.287|TWO_SIDED|95.0|0.681|3.971||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 9||3.971|0.681|0.287
72622159|NCT04003142|144774326|SUPERIORITY||Odds Ratio (OR)|2.108||||0.08||95.0|0.936|5.076||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 9||5.076|0.936|0.080
72554294|NCT00913627|144640414|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.51|||<|0.001|TWO_SIDED|95.0|2.51|4.51||p-value adjusted for baseline PSR and gender|ANOVA|||9 hours||4.51|2.51|<0.001
72554295|NCT00913627|144640414|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.49|||<|0.001|TWO_SIDED|95.0|1.49|3.48||p-value adjusted for baseline PSR and gender|ANOVA|||9 hours||3.48|1.49|<0.001
72554296|NCT00913627|144640414|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.19|||<|0.001|TWO_SIDED|95.0|2.17|4.21||p-value adjusted for baseline PSR and gender|ANOVA|||10 hours||4.21|2.17|<0.001
72554297|NCT00913627|144640414|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.65|||<|0.001|TWO_SIDED|95.0|2.64|4.66||p-value adjusted for baseline PSR and gender|ANOVA|||10 hours||4.66|2.64|<0.001
72554298|NCT00913627|144640414|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.59|||<|0.001|TWO_SIDED|95.0|1.58|3.6||p-value adjusted for baseline PSR and gender|ANOVA|||10 hours||3.60|1.58|<0.001
72554299|NCT00913627|144640414|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.1|||<|0.001|TWO_SIDED|95.0|2.06|4.15||p-value adjusted for baseline PSR and gender|ANOVA|||11 hours||4.15|2.06|<0.001
72554300|NCT00913627|144640414|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.57|||<|0.001|TWO_SIDED|95.0|2.53|4.61||p-value adjusted for baseline PSR and gender|ANOVA|||11 hours||4.61|2.53|<0.001
72554301|NCT00913627|144640414|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.64|||<|0.001|TWO_SIDED|95.0|1.61|3.67||p-value adjusted for baseline PSR and gender|ANOVA|||11 hours||3.67|1.61|<0.001
72554302|NCT00913627|144640414|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.15|||<|0.001|TWO_SIDED|95.0|2.09|4.21||p-value adjusted for baseline PSR and gender|ANOVA|||12 hours||4.21|2.09|<0.001
72554303|NCT00913627|144640414|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.41|||<|0.001|TWO_SIDED|95.0|2.36|4.46||p-value adjusted for baseline PSR and gender|ANOVA|||12 hours||4.46|2.36|<0.001
72554304|NCT00913627|144640414|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.4|||<|0.001|TWO_SIDED|95.0|1.36|3.44||p-value adjusted for baseline PSR and gender|ANOVA|||12 hours||3.44|1.36|<0.001
72554305|NCT00913627|144640414|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.03|||<|0.001|TWO_SIDED|95.0|1.94|4.12||p-value adjusted for baseline PSR and gender|ANOVA|||13 hours||4.12|1.94|<0.001
72554306|NCT00913627|144640414|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.99|||<|0.001|TWO_SIDED|95.0|1.91|4.07||p-value adjusted for baseline PSR and gender|ANOVA|||13 hours||4.07|1.91|<0.001
72554307|NCT00913627|144640414|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.35|||<|0.001|TWO_SIDED|95.0|1.28|3.42||p-value adjusted for baseline PSR and gender|ANOVA|||13 hours||3.42|1.28|<0.001
72554308|NCT00913627|144640414|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.7|||<|0.001|TWO_SIDED|95.0|1.57|3.83||p-value adjusted for baseline PSR and gender|ANOVA|||14 hours||3.83|1.57|<0.001
72554309|NCT00913627|144640414|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.74|||<|0.001|TWO_SIDED|95.0|1.62|3.85||p-value adjusted for baseline PSR and gender|ANOVA|||14 hours||3.85|1.62|<0.001
72554310|NCT00913627|144640414|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.26|||<|0.001|TWO_SIDED|95.0|1.14|3.37||p-value adjusted for baseline PSR and gender|ANOVA|||14 hours||3.37|1.14|<0.001
72554311|NCT00913627|144640414|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.64|||<|0.001|TWO_SIDED|95.0|1.51|3.76||p-value adjusted for baseline PSR and gender|ANOVA|||16 hours||3.76|1.51|<0.001
72554312|NCT00913627|144640414|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.45|||<|0.001|TWO_SIDED|95.0|1.33|3.56||p-value adjusted for baseline PSR and gender|ANOVA|||16 hours||3.56|1.33|<0.001
72554313|NCT00913627|144640414|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.36|||<|0.001|TWO_SIDED|95.0|1.25|3.47||p-value adjusted for baseline PSR and gender|ANOVA|||16 hours||3.47|1.25|<0.001
72554314|NCT00913627|144640414|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.02|||<|0.001|TWO_SIDED|95.0|0.86|3.19||p-value adjusted for baseline PSR and gender|ANOVA|||24 hours||3.19|0.86|<0.001
72554315|NCT00913627|144640414|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.9||||0.001|TWO_SIDED|95.0|0.75|3.05||p-value adjusted for baseline PSR and gender|ANOVA|||24 hours||3.05|0.75|0.001
72554316|NCT00913627|144640414|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.19|||<|0.001|TWO_SIDED|95.0|1.05|3.34||p-value adjusted for baseline PSR and gender|ANOVA|||24 hours||3.34|1.05|<0.001
72554317|NCT00913627|144640415|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.42|||<|0.001|TWO_SIDED|95.0|1.94|2.89||p-value adjusted for baseline PSR and gender|ANOVA|||||2.89|1.94|<0.001
72554318|NCT00913627|144640415|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.39|||<|0.001|TWO_SIDED|95.0|1.92|2.86||p-value adjusted for baseline PSR and gender|ANOVA|||||2.86|1.92|<0.001
72554319|NCT00913627|144640415|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.05|||<|0.001|TWO_SIDED|95.0|1.58|2.52||p-value adjusted for baseline PSR and gender|ANOVA|||||2.52|1.58|<0.001
72554320|NCT01110005|144640416|SUPERIORITY||Risk Ratio (RR)|1.3||||0.34|TWO_SIDED|95.0|0.7|2.3|||Regression, log binomial|The regression model adjusted for site of recruitment as a covariate.|D5LR vs. LR|||2.3|0.7|0.34
72554321|NCT01110005|144640417|SUPERIORITY||Risk Ratio (RR)|1.1||||0.4|TWO_SIDED|95.0|0.9|1.3|||Regression, log binomial|The regression model adjusted for site of recruitment as a covariate.|D5LR vs. LR|||1.3|0.9|0.40
72554322|NCT01110005|144640418|SUPERIORITY|||||||0.69|||||||Cochran-Mantel-Haenszel|This method was used to control for site of recruitment||||||0.69
72554323|NCT01641380|144640419|SUPERIORITY_OR_OTHER_LEGACY||Slope|-0.75|||<|0.05|TWO_SIDED|95.0|-1.4|0.06|||Regression, Linear|||We also evaluated the difference between the number of days after the scheduled appointment patients returned.||.06|-1.4|<.05
72554324|NCT01641380|144640419|SUPERIORITY_OR_OTHER_LEGACY||Difference of proportions|0.417||||0.5187|TWO_SIDED|95.0|-13.3307|24.8818|||Chi-squared||Intervention 34/50; Control : 28/50|On time for 1st follow-up visit||24.8818|-13.3307|0.5187
72554325|NCT01641380|144640422|SUPERIORITY_OR_OTHER_LEGACY||[Proportion of Eligible Patients Enrolle|0.948|||||TWO_SIDED|||||||||||||
72554326|NCT03123471|144640423|SUPERIORITY||Difference in Response|29.6|||<|0.0001|TWO_SIDED|95.0|19.5|39.7|||Cochran-Mantel-Haenszel|Analysis used CMH; adjusted by stratification factor of baseline ScPGA score moderate (3) or severe (4).||The adjusted difference in response rates using the weighted average of the treatment differences across the strata with the CMH weights and the 2-sided 95% confidence interval using a normal approximation to the weighted average were calculated.||39.7|19.5|< 0.0001
72554327|NCT03123471|144640424|SUPERIORITY||Difference in Response|23.0|||<|0.0001|TWO_SIDED|95.0|11.5|34.6|||Cochran-Mantel-Haenszel|Analysis used CMH; adjusted by stratification factor of baseline ScPGA score moderate (3) or severe (4).||The adjusted difference in response rates using the weighted average of the treatment differences across the strata with the CMH weights and the 2-sided 95% confidence interval using a normal approximation to the weighted average were calculated.||34.6|11.5|< 0.0001
72554328|NCT03123471|144640425|SUPERIORITY||Difference in Response|26.2|||<|0.0001|TWO_SIDED|95.0|13.9|38.5|||Cochran-Mantel-Haenszel|Analysis used CMH; adjusted by stratification factor of baseline ScPGA score moderate (3) or severe (4).||The adjusted difference in response rates using the weighted average of the treatment differences across the strata with the CMH weights and the 2-sided 95% confidence interval using a normal approximation to the weighted average were calculated.||38.5|13.9|< 0.0001
72554329|NCT03123471|144640426|SUPERIORITY||Difference in Response|17.0|||<|0.0001|TWO_SIDED|95.0|9.8|24.2|||Cochran-Mantel-Haenszel|Analysis used CMH; adjusted by stratification factor of baseline ScPGA score moderate (3) or severe (4).||Week 2; The adjusted difference in response rates using the weighted average of the treatment differences across the strata with the CMH weights and the 2-sided 95% confidence interval using a normal approximation to the weighted average were calculated.||24.2|9.8|<0.0001
72554330|NCT03123471|144640426|SUPERIORITY||Difference in Response|22.1|||<|0.0001|TWO_SIDED|95.0|12.9|31.4|||Cochran-Mantel-Haenszel|Analysis used CMH; adjusted by stratification factor of baseline ScPGA score moderate (3) or severe (4).||Week 4. The adjusted difference in response rates using the weighted average of the treatment differences across the strata with the CMH weights and the 2-sided 95% confidence interval using a normal approximation to the weighted average were calculated.||31.4|12.9|<0.0001
72554331|NCT03123471|144640426|SUPERIORITY||Difference in Response|20.1||||0.0003|TWO_SIDED|95.0|9.1|31.0|||Cochran-Mantel-Haenszel|Analysis used CMH; adjusted by stratification factor of baseline ScPGA score moderate (3) or severe (4).||Week 8; The adjusted difference in response rates using the weighted average of the treatment differences across the strata with the CMH weights and the 2-sided 95% confidence interval using a normal approximation to the weighted average were calculated.||31.0|9.1|0.0003
72554332|NCT03123471|144640426|SUPERIORITY||Difference in Response|20.6||||0.0007|TWO_SIDED|95.0|8.7|32.4|||Cochran-Mantel-Haenszel|Analysis used CMH; adjusted by stratification factor of baseline ScPGA score moderate (3) or severe (4).||Week 12; The adjusted difference in response rates using the weighted average of the treatment differences across the strata with the CMH weights and SE using a normal approximation to the weighted average were calculated.||32.4|8.7|0.0007
72554333|NCT03123471|144640427|SUPERIORITY||Difference in Response|14.6||||0.0025|TWO_SIDED|95.0|5.1|24.1|||Cochran-Mantel-Haenszel|Analysis used CMH; adjusted by stratification factor of baseline ScPGA score moderate (3) or severe (4).||Week 2; The adjusted difference in response rates using the weighted average of the treatment differences across the strata with the CMH weights and the 2-sided 95% confidence interval using a normal approximation to the weighted average were calculated.||24.1|5.1|0.0025
72554334|NCT03123471|144640427|SUPERIORITY||Difference in Response|21.3|||<|0.0001|TWO_SIDED|95.0|10.6|31.9|||Cochran-Mantel-Haenszel|Analysis used CMH; adjusted by stratification factor of baseline ScPGA score moderate (3) or severe (4).||Week 4; The adjusted difference in response rates using the weighted average of the treatment differences across the strata with the CMH weights and the 2-sided 95% confidence interval using a normal approximation to the weighted average were calculated.||31.9|10.6|<0.0001
72554335|NCT03123471|144640427|SUPERIORITY||Difference in Response|22.0||||0.0003|TWO_SIDED|95.0|10.2|33.9|||Cochran-Mantel-Haenszel|Analysis used CMH; adjusted by stratification factor of baseline ScPGA score moderate (3) or severe (4).||Week 8; The adjusted difference in response rates using the weighted average of the treatment differences across the strata with the CMH weights and the 2-sided 95% confidence interval using a normal approximation to the weighted average were calculated.||33.9|10.2|0.0003
72554336|NCT03123471|144640427|SUPERIORITY||Difference in Response|27.0|||<|0.0001|TWO_SIDED|95.0|15.1|38.9|||Cochran-Mantel-Haenszel|Analysis used CMH; adjusted by stratification factor of baseline ScPGA score moderate (3) or severe (4).||Week 12; The adjusted difference in response rates using the weighted average of the treatment differences across the strata with the CMH weights and SE using a normal approximation to the weighted average were calculated.||38.9|15.1|<0.0001
72554337|NCT03123471|144640428|SUPERIORITY||Difference in LS Mean|-2.9|||<|0.0001|TWO_SIDED|95.0|-4.17|-1.73|||ANCOVA|Treatment and stratification factor (Baseline ScPGA moderate or severe) as independent variables and baseline value as a covariate variable.||||-1.73|-4.17|<0.0001
72554338|NCT03290781|144640472|SUPERIORITY||Difference in Proportion|0.451|||<|0.001|TWO_SIDED|95.0|0.296|0.572||P-value was based on CMH chi-square test stratified by status of glucocorticoid use at SHP647-303 baseline, prior anti-TNF treatment, and the degree of clinical response in the induction studies (whether remission is achieved or not).|Cochran-Mantel-Haenszel|||||0.572|0.296|<0.001
72554339|NCT03290781|144640472|SUPERIORITY||Difference in Proportion|0.278|||<|0.001|TWO_SIDED|95.0|0.142|0.401||P-value was based on CMH chi-square test stratified by status of glucocorticoid use at SHP647-303 baseline, prior anti-TNF treatment, and the degree of clinical response in the induction studies (whether remission is achieved or not).|Cochran-Mantel-Haenszel|||||0.401|0.142|<0.001
72554340|NCT03290781|144640473|SUPERIORITY||Difference in Proportion|0.463|||<|0.001|TWO_SIDED|95.0|0.31|0.585||P-value was based on CMH chi-square test stratified by status of glucocorticoid use at SHP647-303 baseline, prior anti-TNF treatment, and the degree of clinical response in the induction studies (whether remission is achieved or not).|Cochran-Mantel-Haenszel|||||0.585|0.310|<0.001
72554341|NCT03290781|144640473|SUPERIORITY||Difference in Proportion|0.339|||<|0.001|TWO_SIDED|95.0|0.197|0.463||P-value was based on CMH chi-square test stratified by status of glucocorticoid use at SHP647-303 baseline, prior anti-TNF treatment, and the degree of clinical response in the induction studies (whether remission is achieved or not).|Cochran-Mantel-Haenszel|||||0.463|0.197|<0.001
72554342|NCT03290781|144640474|SUPERIORITY||Difference in Proportion|0.497|||<|0.001|TWO_SIDED|95.0|0.337|0.62||P-value was based on CMH chi-square test stratified by status of glucocorticoid use at SHP647-303 baseline, prior anti-TNF treatment, and the degree of clinical response in the induction studies (whether remission is achieved or not).|Cochran-Mantel-Haenszel|||||0.620|0.337|<0.001
72554343|NCT03290781|144640474|SUPERIORITY||Difference in Proportion|0.294|||<|0.001|TWO_SIDED|95.0|0.148|0.425||P-value was based on CMH chi-square test stratified by status of glucocorticoid use at SHP647-303 baseline, prior anti-TNF treatment, and the degree of clinical response in the induction studies (whether remission is achieved or not).|Cochran-Mantel-Haenszel|||||0.425|0.148|<0.001
72469426|NCT01018732|144462514|SUPERIORITY_OR_OTHER||ratio of titer|3.61|||||TWO_SIDED|95.0|1.94|6.74||||||Day 1, Men Y, Pairwise comparison of geometric mean titer||6.74|1.94|
72554344|NCT03290781|144640475|SUPERIORITY||Difference in Proportion|0.277|||<|0.001|TWO_SIDED|95.0|0.129|0.398||P-value was based on CMH chi-square test stratified by status of glucocorticoid use at SHP647-303 baseline, prior anti-TNF treatment, and the degree of clinical response in the induction studies (whether remission is achieved or not).|Cochran-Mantel-Haenszel|||||0.398|0.129|<0.001
72554345|NCT03290781|144640475|SUPERIORITY||Difference in Proportion|0.191|||<|0.001|TWO_SIDED|95.0|0.067|0.305||P-value was based on CMH chi-square test stratified by status of glucocorticoid use at SHP647-303 baseline, prior anti-TNF treatment, and the degree of clinical response in the induction studies (whether remission is achieved or not).|Cochran-Mantel-Haenszel|||||0.305|0.067|<0.001
72554346|NCT03290781|144640476|SUPERIORITY||Difference in Proportion|0.488|||<|0.001|TWO_SIDED|95.0|0.329|0.613||P-value was based on CMH chi-square test stratified by status of glucocorticoid use at SHP647-303 baseline, prior anti-TNF treatment, and the degree of clinical response in the induction studies (whether remission is achieved or not).|Cochran-Mantel-Haenszel|||||0.613|0.329|<0.001
72554347|NCT03290781|144640476|SUPERIORITY||Difference in Proportion|0.343|||<|0.001|TWO_SIDED|95.0|0.194|0.471||P-value was based on CMH chi-square test stratified by status of glucocorticoid use at SHP647-303 baseline, prior anti-TNF treatment, and the degree of clinical response in the induction studies (whether remission is achieved or not).|Cochran-Mantel-Haenszel|||||0.471|0.194|<0.001
72554348|NCT03290781|144640477|SUPERIORITY||Difference in Proportion|0.431|||<|0.001|TWO_SIDED|95.0|0.28|0.554||P-value was based on CMH chi-square test stratified by status of glucocorticoid use at SHP647-303 baseline, prior anti-TNF treatment, and the degree of clinical response in the induction studies (whether remission is achieved or not).|Cochran-Mantel-Haenszel|||||0.554|0.280|<0.001
72554349|NCT03290781|144640477|SUPERIORITY||Difference in Proportion|0.227|||<|0.001|TWO_SIDED|95.0|0.094|0.349||P-value was based on CMH chi-square test stratified by status of glucocorticoid use at SHP647-303 baseline, prior anti-TNF treatment, and the degree of clinical response in the induction studies (whether remission is achieved or not).|Cochran-Mantel-Haenszel|||||0.349|0.094|<0.001
72554350|NCT03290781|144640478|SUPERIORITY||Difference in Proportion|0.176|||<|0.001|TWO_SIDED|95.0|0.049|0.287||P-value was based on CMH chi-square test stratified by status of glucocorticoid use at SHP647-303 baseline, prior anti-TNF treatment, and the degree of clinical response in the induction studies (whether remission is achieved or not).|Cochran-Mantel-Haenszel|||||0.287|0.049|<0.001
72554351|NCT03290781|144640478|SUPERIORITY||Difference in Proportion|0.111|||<|0.005|TWO_SIDED|95.0|0.006|0.208||P-value was based on CMH chi-square test stratified by status of glucocorticoid use at SHP647-303 baseline, prior anti-TNF treatment, and the degree of clinical response in the induction studies (whether remission is achieved or not).|Cochran-Mantel-Haenszel|||||0.208|0.006|<0.005
72554352|NCT03290781|144640479|SUPERIORITY||||||<|0.001||||||P-value was based on CMH chi-square test stratified by status of glucocorticoid use at SHP647-303 baseline, prior anti-TNF treatment, and the degree of clinical response in the induction studies (whether remission is achieved or not).|Cochran-Mantel-Haenszel|||||||<0.001
72469427|NCT01018732|144462514|SUPERIORITY_OR_OTHER||ratio of titer|3.24|||||TWO_SIDED|95.0|1.71|6.13|||ANOVA|||Day 1, Men Y, Pairwise comparison of geometric mean titer||6.13|1.71|
72554353|NCT03290781|144640479|SUPERIORITY||||||=|0.005||||||P-value was based on CMH chi-square test stratified by status of glucocorticoid use at SHP647- 303 baseline, prior anti-TNF treatment, and the degree of clinical response in the induction studies (whether remission is achieved or not).|Cochran-Mantel-Haenszel|||||||=0.005
72554354|NCT03238781|144640513|SUPERIORITY||difference in least square mean|0.26||||0.66|TWO_SIDED|95.0|-0.88|1.4||2-sided significance level of 0.05|Mixed Models Analysis|||An adjusted analysis is presented that utilized a generalized linear mixed model which included treatment, visit, treatment-by-visit interaction, stratification factors of region and baseline migraine frequency (chronic migraine vs episodic migraine), and baseline value as covariates and assuming a first-order autoregressive covariance structure. The p-values for pairwise comparisons versus placebo are nominal p-values without multiplicity adjustment.||1.40|-0.88|0.66
72554355|NCT03238781|144640513|SUPERIORITY||difference in least square mean|0.27||||0.65|TWO_SIDED|95.0|-0.89|1.43||2-sided significance level of 0.05|Mixed Models Analysis|||An adjusted analysis is presented that utilized a generalized linear mixed model which included treatment, visit, treatment-by-visit interaction, stratification factors of region and baseline migraine frequency (chronic migraine vs episodic migraine), and baseline value as covariates and assuming a first-order autoregressive covariance structure. The p-values for pairwise comparisons versus placebo are nominal p-values without multiplicity adjustment.||1.43|-0.89|0.65
72554356|NCT03238781|144640514|SUPERIORITY||Odds Ratio (OR)|0.82||||0.57|TWO_SIDED|95.0|0.41|1.62||2-sided significance level of 0.05|Cochran-Mantel-Haenszel|||The common odds ratios and p-values are obtained from a Cochran-Mantel-Haenszel test, stratified by stratification factors of region and baseline migraine frequency (chronic migraine vs episodic migraine).||1.62|0.41|0.57
72554357|NCT03238781|144640514|SUPERIORITY||Odds Ratio (OR)|0.76||||0.45|TWO_SIDED|95.0|0.37|1.54||2-sided significance level of 0.05|Cochran-Mantel-Haenszel|||The common odds ratios and p-values are obtained from a Cochran-Mantel-Haenszel test, stratified by stratification factors of region and baseline migraine frequency (chronic migraine vs episodic migraine).||1.54|0.37|0.45
72554358|NCT03238781|144640515|SUPERIORITY||difference in least square mean|-0.03||||0.94|TWO_SIDED|95.0|-0.87|0.81||2-sided significance level of 0.05|Mixed Models Analysis|||Adjusted analysis utilizes a generalized linear mixed model which includes treatment, visit, treatment-by-visit interaction, stratification factors of region and baseline migraine frequency (CM versus EM), and baseline value as covariates and assuming a first-order autoregressive covariance structure. The p-values for pairwise comparisons versus placebo are nominal p-values without multiplicity adjustment.||0.81|-0.87|0.94
72554359|NCT03238781|144640515|SUPERIORITY||difference in least square mean|-0.09||||0.84|TWO_SIDED|95.0|-0.94|0.77||2-sided significance level of 0.05|Mixed Models Analysis|||||0.77|-0.94|0.84
72554360|NCT03238781|144640516|SUPERIORITY||difference in least square mean|-0.28||||0.81|TWO_SIDED|95.0|-2.56|2.01||2-sided significance level of 0.05|Mixed Models Analysis|||An adjusted analysis is presented that utilized a generalized linear mixed model which included treatment, visit, treatment-by-visit interaction, stratification factors of region and baseline migraine frequency (chronic migraine vs episodic migraine), and baseline value as covariates and assuming a first-order autoregressive covariance structure. The p-values for pairwise comparisons versus placebo are nominal p-values without multiplicity adjustment.||2.01|-2.56|0.81
72554361|NCT03238781|144640516|SUPERIORITY||difference in least square mean|0.31||||0.79|TWO_SIDED|95.0|-2.01|2.63||2-sided significance level of 0.05|Mixed Models Analysis|||An adjusted analysis is presented that utilized a generalized linear mixed model which included treatment, visit, treatment-by-visit interaction, stratification factors of region and baseline migraine frequency (chronic migraine vs episodic migraine), and baseline value as covariates and assuming a first-order autoregressive covariance structure. The p-values for pairwise comparisons versus placebo are nominal p-values without multiplicity adjustment.||2.63|-2.01|0.79
72554362|NCT03238781|144640517|SUPERIORITY||difference in least square mean|-0.86||||0.46|TWO_SIDED|95.0|-3.15|1.44||2-sided significance level of 0.05|Mixed Models Analysis|||An adjusted analysis is presented that utilized a generalized linear mixed model which included treatment, visit, treatment-by-visit interaction, stratification factors of region and baseline migraine frequency (chronic migraine vs episodic migraine), and baseline value as covariates and assuming a first-order autoregressive covariance structure. The p-values for pairwise comparisons versus placebo are nominal p-values without multiplicity adjustment.||1.44|-3.15|0.46
72469428|NCT01018732|144462514|SUPERIORITY_OR_OTHER||ratio of titer|0.33|||||TWO_SIDED|95.0|0.16|0.66|||ANOVA|||Day 8, Men Y, Pairwise comparison of geometric mean titer||0.66|0.16|
72554363|NCT03238781|144640517|SUPERIORITY||difference in least square mean|0.56||||0.64|TWO_SIDED|95.0|-1.77|2.89||2-sided significance level of 0.05|Mixed Models Analysis|||An adjusted analysis is presented that utilized a generalized linear mixed model which included treatment, visit, treatment-by-visit interaction, stratification factors of region and baseline migraine frequency (chronic migraine vs episodic migraine), and baseline value as covariates and assuming a first-order autoregressive covariance structure. The p-values for pairwise comparisons versus placebo are nominal p-values without multiplicity adjustment.||2.89|-1.77|0.64
72622160|NCT04003142|144774326|SUPERIORITY||Odds Ratio (OR)|1.599||||0.247|TWO_SIDED|95.0|0.73|3.636||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 10||3.636|0.730|0.247
72554364|NCT02301975|144640558|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was defined if the lower bound of the 95% CI for the difference between mean change from Baseline in clinic visit PM FEV1 for FF/VI and FP/S was more than -100 milliliter (mL)|Least square mean change difference|0.019|||||TWO_SIDED|95.0|-0.011|0.049||||||||0.049|-0.011|
72554365|NCT02301975|144640558|OTHER||Least square mean change difference|0.123|||<|0.001|TWO_SIDED|95.0|0.093|0.153|||Mixed Models Analysis|||||0.153|0.093|<0.001
72554366|NCT02301975|144640558|OTHER||Least square mean change difference|0.104|||<|0.001|TWO_SIDED|95.0|0.074|0.134|||Mixed Models Analysis|||||0.134|0.074|<0.001
72554367|NCT02301975|144640559|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was defined if the lower bound of the 95% CI for the difference between mean change from Baseline in clinic visit for FF/VI and FP/S was more than -100 mL|Least square mean change difference|0.006|||||TWO_SIDED|95.0|-0.027|0.04||||||||0.040|-0.027|
72554368|NCT02301975|144640559|OTHER||Least square mean change difference|0.12|||<|0.001|TWO_SIDED|95.0|0.086|0.153|||Mixed Models Analysis|||||0.153|0.086|<0.001
72554369|NCT02301975|144640559|OTHER||Least square mean change difference|0.113|||<|0.001|TWO_SIDED|95.0|0.08|0.147|||Mixed Models Analysis|||||0.147|0.080|<0.001
72554370|NCT02301975|144640560|OTHER||Least square mean change difference|1.2|||||TWO_SIDED|95.0|-0.5|3.0||||||||3.0|-0.5|
72554371|NCT02301975|144640560|OTHER||Least square mean change difference|2.7||||0.002|TWO_SIDED|95.0|0.9|4.4|||ANCOVA|||||4.4|0.9|0.002
72554372|NCT02301975|144640560|OTHER||Least square mean change difference|1.4||||0.106|TWO_SIDED|95.0|-0.3|3.2|||ANCOVA|||||3.2|-0.3|0.106
72554373|NCT02301975|144640561|OTHER||Least square mean change difference|1.2|||||TWO_SIDED|95.0|-0.7|3.1||||||||3.1|-0.7|
72554374|NCT02301975|144640561|OTHER||Least square mean change difference|2.7||||0.004|TWO_SIDED|95.0|0.8|4.5|||ANCOVA|||||4.5|0.8|0.004
72554375|NCT02301975|144640561|OTHER||Least square mean change difference|1.5||||0.115|TWO_SIDED|95.0|-0.4|3.3|||ANCOVA|||||3.3|-0.4|0.115
72622161|NCT04003142|144774326|SUPERIORITY||Odds Ratio (OR)|2.481||||0.017||95.0|1.201|5.441||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 10||5.441|1.201|0.017
72622162|NCT04003142|144774326|SUPERIORITY||Odds Ratio (OR)|1.728||||0.212||95.0|0.744|4.236||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 11||4.236|0.744|0.212
72469429|NCT01018732|144462514|SUPERIORITY_OR_OTHER||ratio of titer|121.0|||||TWO_SIDED|95.0|61.0|241.0|||ANOVA|||Day 8, Men Y, Pairwise comparison of geometric mean titer||241|61|
72554376|NCT02301975|144640562|OTHER||Least square mean change difference|5.2|||||TWO_SIDED|95.0|1.1|9.4||||||||9.4|1.1|
72554377|NCT02301975|144640562|OTHER||Least square mean change difference|21.5|||<|0.001|TWO_SIDED|95.0|17.4|25.6|||ANCOVA|||||25.6|17.4|<0.001
72554378|NCT02301975|144640562|OTHER||Least square mean change difference|16.3|||<|0.001|TWO_SIDED|95.0|12.2|20.4|||ANCOVA|||||20.4|12.2|<0.001
72554379|NCT02301975|144640563|OTHER||Odds Ratio (OR)|0.91|||||TWO_SIDED|95.0|0.53|1.54||||||||1.54|0.53|
72554380|NCT02301975|144640563|OTHER||Odds Ratio (OR)|1.15||||0.595|TWO_SIDED|95.0|0.69|1.9|||Regression, Logistic|||||1.90|0.69|0.595
72554381|NCT02301975|144640563|OTHER||Odds Ratio (OR)|1.27||||0.372|TWO_SIDED|95.0|0.75|2.12|||Regression, Logistic|||||2.12|0.75|0.372
72554382|NCT02301975|144640564|OTHER||Least square mean change difference|5.0|||||TWO_SIDED|95.0|0.7|9.3||||||||9.3|0.7|
72554383|NCT02301975|144640564|OTHER||Least square mean change difference|19.2|||<|0.001|TWO_SIDED|95.0|14.9|23.5|||ANCOVA|||||23.5|14.9|<0.001
72554384|NCT02301975|144640564|OTHER||Least square mean change difference|14.2|||<|0.001|TWO_SIDED|95.0|9.9|18.5|||ANCOVA|||||18.5|9.9|<0.001
72554385|NCT03049748|144640585|OTHER|This is a pilot randomized trial with a purpose of establishing preliminary efficacy data to inform future studies.|||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
72554386|NCT03049748|144640586|OTHER|Same rationale as the primary outcome.|||||>|0.05||||||All p-values across time periods, between groups, were \> .05|Wilcoxon (Mann-Whitney)|||||||>.05
72554387|NCT03049748|144640587|OTHER||||||>|0.05||||||All p values between groups across time periods were \> .05|Wilcoxon (Mann-Whitney)|||||||>.05
72554388|NCT03049748|144640588|OTHER||||||>|0.05||||||All p-values between groups across time periods were \>.05|Wilcoxon (Mann-Whitney)|||||||>.05
72554389|NCT03049748|144640589|OTHER||||||>|0.05||||||All p-values between group differences across time periods were \> .05|Wilcoxon (Mann-Whitney)|||||||>.05
72554390|NCT03049748|144640590|OTHER|||||||0.05||||||Differences in group hospitalization rates p-values: T1 = .093; T2 = .008; T3 = .029|Wilcoxon (Mann-Whitney)|||||||0.05
72554391|NCT00905840|144640598|NON_INFERIORITY_OR_EQUIVALENCE|The analysis of the primary outcome variable, was based on a confirmatory non-inferiority test with a one-sided 97.5% confidence interval. The non-inferiority margin for a clinically relevant difference was set at 0.1 mm. For a sample size of st least 73, a paired t-test with a 0.0025 one-sided significant level was calculated to have 80% power to reject the hypothesis that the test is inferior to the standard.|Mean Difference (Final Values)|0.1||||0.025|TWO_SIDED|97.5|0.1|0.3|||Student's t-test|||"Null hypothesis: Change of functional bone level at the test implant 12 month after surgery is more than 0.1 lower (inferior) than change of functional crestal bone level at the control implant 12 month after surgery.~H-1: Change of functional bone level at the tst implant 12 month after surgery is up to 0.1 lower, equal, or higher (not inferior) than change of functional crestal bone level at the control implant 12 month after surgery."||0.3|0.1|0.025
72554392|NCT00905840|144640599|SUPERIORITY_OR_OTHER|||||||0.1573|TWO_SIDED|95.0|||||McNemar|||This analysis is up to 12 month.||||0.1573
72554393|NCT00905840|144640600|SUPERIORITY_OR_OTHER|||||||0.3617|TWO_SIDED|||||12 month data Plaque index|Wilcoxon (Mann-Whitney)|||||||0.3617
72554394|NCT00905840|144640600|SUPERIORITY_OR_OTHER|||||||0.7068|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|24 month data Plaque index||||||0.7068
72554395|NCT00905840|144640600|SUPERIORITY_OR_OTHER|||||||0.4312|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|36 month data Plaque Index||||||0.4312
72554396|NCT00905840|144640600|SUPERIORITY_OR_OTHER|||||||0.9933|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|12 month data Sulcus Bleeding Index||||||0.9933
72554397|NCT00905840|144640600|SUPERIORITY_OR_OTHER|||||||0.3667|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|24 month data Sulcus Bleeding Index||||||0.3667
72554398|NCT00905840|144640600|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|36 month data Sulcus Bleeding Index||||||1.0000
72554399|NCT03181594|144640650|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||The null hypothesis was that the mean change from baseline for the rTNSS would be 0 (no effect). Assumptions included an alpha level of 0.5 (2-tailed), 90% power, and a standard deviation of 2.5 for the mean change from baseline. A total of 68 participants was deemed adequate to test the hypothesis.||||<0.001
72554400|NCT03181594|144640652|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
72554401|NCT03181594|144640653|SUPERIORITY||||||<|0.001||||||p\<0.001 at all time periods. p\<0.05 was considered statistically significant.|Wilcoxon signed rank|||||||<0.001
72554402|NCT01175018|144640692|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||ANOVA|||||||<0.05
72554403|NCT01175018|144640693|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||ANOVA|||||||>0.05
72554404|NCT01175018|144640694|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Chi-squared|||||||>0.05
72554405|NCT01175018|144640695|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||ANOVA|||||||>0.05
72554406|NCT01175018|144640696|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Log Rank|||||||<0.05
72554407|NCT01175018|144640697|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Chi-squared|||||||>0.05
72554408|NCT01175018|144640698|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||ANOVA|||||||>0.05
72554409|NCT01175018|144640699|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||ANOVA|||||||>0.05
72554410|NCT01175018|144640700|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||ANOVA|||||||>0.05
72554411|NCT01175018|144640701|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Chi-squared|||||||>0.05
72554412|NCT01175018|144640702|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Chi-squared|||||||>0.05
72554413|NCT01175018|144640703|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Chi-squared|||||||>0.05
72432059|NCT00797225|144376619|SUPERIORITY||LS Mean Difference|-0.63|STANDARD_ERROR_OF_MEAN|0.28||0.028|TWO_SIDED|95.0|-1.19|-0.07|||Mixed-effects Repeated Measures Model|||Analysis at Week 8. The change from baseline in monthly mean values of the NRS for overall endometriosis-associated pelvic pain was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.||-0.07|-1.19|0.0280
72432060|NCT00797225|144376619|SUPERIORITY||LS Mean Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.29||0.6904|TWO_SIDED|95.0|-0.7|0.46|||Mixed-effects Repeated Measures Model|||Analysis at Week 12. The change from baseline in monthly mean values of the NRS for overall endometriosis-associated pelvic pain was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.||0.46|-0.70|0.6904
72554414|NCT01175018|144640704|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Chi-squared|||||||>0.05
72554415|NCT01175018|144640705|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Chi-squared|||||||>0.05
72554416|NCT01175018|144640706|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Chi-squared|||||||>0.05
72554417|NCT01175018|144640707|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Chi-squared|||||||>0.05
72554418|NCT00840073|144640713|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Ratio of Geometric Means|96.0||||||90.0|85.13|108.27|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||108.27|85.13|
72554419|NCT00840073|144640714|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Ratio of Geometric Means|103.81||||||90.0|96.72|111.41|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||111.41|96.72|
72554420|NCT00840073|144640715|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Ratio of Geometric Means|102.37||||||90.0|97.34|107.65|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||107.65|97.34|
72554421|NCT00840073|144640716|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Ratio of Geometric Means|103.76||||||90.0|100.08|107.57|||||Informational Purposes Only|||107.57|100.08|
72554422|NCT00840073|144640717|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Ratio of Least Squares Means|103.34||||||90.0|100.84|105.92|||||Informational Purposes Only|||105.92|100.84|
72554423|NCT02354339|144640758|SUPERIORITY|||||||0.24||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of fasting glucose on Irvingia gabonensis group||||0.240
72554424|NCT02354339|144640758|SUPERIORITY|||||||0.85||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of fasting glucose on placebo group||||0.850
72554425|NCT02354339|144640759|SUPERIORITY|||||||0.012||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of triglycerides on Irvingia gabonensis group||||0.012
72554426|NCT02354339|144640759|SUPERIORITY|||||||0.391||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of triglycerides on placebo group||||0.391
72554427|NCT02354339|144640760|SUPERIORITY|||||||0.206||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of HDL-c on Irvingia gabonensis group||||0.206
72554428|NCT02354339|144640760|SUPERIORITY|||||||0.721||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of HDL-c on placebo group||||0.721
72554429|NCT02354339|144640761|SUPERIORITY|||||||0.371||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of systolic blood pressure on Irvingia gabonensis group||||0.371
72554430|NCT02354339|144640761|SUPERIORITY|||||||0.238||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of systolic blood pressure on placebo group||||0.238
72554431|NCT02354339|144640762|SUPERIORITY|||||||0.452||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of diastolic blood pressure on Irvingia gabonensis group||||0.452
72554432|NCT02354339|144640762|SUPERIORITY|||||||0.801||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of diastolic blood pressure on placebo group||||0.801
72554433|NCT02354339|144640763|SUPERIORITY|||||||0.005||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of waist circumference on Irvingia gabonensis group||||0.005
72554434|NCT02354339|144640763|SUPERIORITY|||||||0.752||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of waist circumference on placebo group||||0.752
72432061|NCT00797225|144376619|SUPERIORITY||LS Mean Difference|-0.25|STANDARD_ERROR_OF_MEAN|0.29||0.4022|TWO_SIDED|95.0|-0.83|0.33|||Mixed-effects Repeated Measures Model|||Analysis at Week 12. The change from baseline in monthly mean values of the NRS for overall endometriosis-associated pelvic pain was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.||0.33|-0.83|0.4022
72432062|NCT00797225|144376619|SUPERIORITY||LS Mean Difference|-0.59|STANDARD_ERROR_OF_MEAN|0.29||0.0451|TWO_SIDED|95.0|-1.17|-0.01|||Mixed-effects Repeated Measures Model|||Analysis at Week 12. The change from baseline in monthly mean values of the NRS for overall endometriosis-associated pelvic pain was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.||-0.01|-1.17|0.0451
72432063|NCT00797225|144376620|SUPERIORITY||LS Mean Difference|-1.62|STANDARD_ERROR_OF_MEAN|0.48||0.0007|TWO_SIDED|95.0|-2.56|-0.69|||Mixed-effects Repeated Measures Model|||Analysis at Week 4. The change from baseline in monthly peak value of the NRS for overall endometriosis-associated pelvic pain was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.||-0.69|-2.56|0.0007
72432064|NCT00797225|144376620|SUPERIORITY||LS Mean Difference|-1.63|STANDARD_ERROR_OF_MEAN|0.47||0.0006|TWO_SIDED|95.0|-2.56|-0.7|||Mixed-effects Repeated Measures Model|||Analysis at Week 4. The change from baseline in monthly peak value of the NRS for overall endometriosis-associated pelvic pain was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.||-0.70|-2.56|0.0006
72432065|NCT00797225|144376620|SUPERIORITY||LS Mean Difference|-1.28|STANDARD_ERROR_OF_MEAN|0.47||0.0073|TWO_SIDED|95.0|-2.21|-0.35|||Mixed-effects Repeated Measures Model|||Analysis at Week 4. The change from baseline in monthly peak value of the NRS for overall endometriosis-associated pelvic pain was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.||-0.35|-2.21|0.0073
72432066|NCT00797225|144376620|SUPERIORITY||LS Mean Difference|-1.34|STANDARD_ERROR_OF_MEAN|0.48||0.0054|TWO_SIDED|95.0|-2.28|-0.4|||Mixed-effects Repeated Measures Model|||Analysis at Week 8. The change from baseline in monthly peak value of the NRS for overall endometriosis-associated pelvic pain was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.||-0.40|-2.28|0.0054
72432067|NCT00797225|144376620|SUPERIORITY||LS Mean Difference|-2.07|STANDARD_ERROR_OF_MEAN|0.48|<|0.0001|TWO_SIDED|95.0|-3.01|-1.12|||Mixed-effects Repeated Measures Model|||Analysis at Week 8. The change from baseline in monthly peak value of the NRS for overall endometriosis-associated pelvic pain was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.||-1.12|-3.01|< 0.0001
72432068|NCT00797225|144376620|SUPERIORITY||LS Mean Difference|-2.73|STANDARD_ERROR_OF_MEAN|0.48|<|0.0001|TWO_SIDED|95.0|-3.67|-1.79|||Mixed-effects Repeated Measures Model|||Analysis at Week 8. The change from baseline in monthly peak value of the NRS for overall endometriosis-associated pelvic pain was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.||-1.79|-3.67|< 0.0001
72432069|NCT00797225|144376620|SUPERIORITY||LS Mean Difference|-0.95|STANDARD_ERROR_OF_MEAN|0.48||0.0509|TWO_SIDED|95.0|-1.89|0.0|||Mixed-effects Repeated Measures Model|||Analysis at Week 12. The change from baseline in monthly peak value of the NRS for overall endometriosis-associated pelvic pain was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.||0.00|-1.89|0.0509
72469430|NCT01018732|144462514|SUPERIORITY_OR_OTHER||ratio of titer|40.0|||||TWO_SIDED|95.0|20.0|80.0|||ANOVA|||Day 8, Men Y, Pairwise comparison of geometric mean titer||80|20|
72554435|NCT02354339|144640764|SUPERIORITY|||||||0.791|||||||Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of first phase of insulin secretion on Irvingia gabonensis group||||0.791
72554436|NCT02354339|144640764|SUPERIORITY|||||||0.91||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of first phase of insulin secretion on placebo group||||0.910
72554437|NCT02354339|144640765|SUPERIORITY|||||||0.458||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of total insulin secretion on Irvingia gabonensis group||||0.458
72554438|NCT02354339|144640765|SUPERIORITY|||||||0.953||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of total insulin secretion on placebo group||||0.953
72554439|NCT02354339|144640766|SUPERIORITY|||||||0.47||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of insulin sensitivity on Irvingia gabonensis group||||0.470
72554440|NCT02354339|144640766|SUPERIORITY|||||||0.807||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of insulin sensitivity on placebo group||||0.807
72432070|NCT00797225|144376620|SUPERIORITY||LS mean Difference|-1.38|STANDARD_ERROR_OF_MEAN|0.48||0.0046|TWO_SIDED|95.0|-2.33|-0.43|||Mixed-effects Repeated Measures Model|||Analysis at Week 12. The change from baseline in monthly peak value of the NRS for overall endometriosis-associated pelvic pain was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.||-0.43|-2.33|0.0046
72432071|NCT00797225|144376620|SUPERIORITY||LS Mean Difference|-2.32|STANDARD_ERROR_OF_MEAN|0.48|<|0.0001|TWO_SIDED|95.0|-3.26|-1.38|||Mixed-effects Repeated Measures Model|||Analysis at Week 12. The change from baseline in monthly peak value of the NRS for overall endometriosis-associated pelvic pain was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.||-1.38|-3.26|< 0.0001
72432072|NCT00797225|144376621|SUPERIORITY||LS Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.08||0.0453|TWO_SIDED|95.0|-0.33|0.0|||Mixed-effects Repeated Measures Model|||Analysis at Week 4. The change from baseline in monthly mean non-menstrual pelvic pain scores was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.||0.00|-0.33|0.0453
72432073|NCT00797225|144376621|SUPERIORITY||LS Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.08||0.0609|TWO_SIDED|95.0|-0.31|0.01|||Mixed-effects Repeated Measures Model|||Analysis at Week 4. The change from baseline in monthly mean non-menstrual pelvic pain scores was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.||0.01|-0.31|0.0609
72432074|NCT00797225|144376621|SUPERIORITY||LS Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.08||0.0069|TWO_SIDED|95.0|-0.38|-0.06|||Mixed-effects Repeated Measures Model|||Analysis at Week 4. The change from baseline in monthly mean non-menstrual pelvic pain scores was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.||-0.06|-0.38|0.0069
72432075|NCT00797225|144376621|SUPERIORITY||LS Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.08||0.0556|TWO_SIDED|95.0|-0.32|0.0|||Mixed-effects Repeated Measures Model]|||Analysis at Week 8. The change from baseline in monthly mean non-menstrual pelvic pain scores was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.||0.00|-0.32|0.0556
72432076|NCT00797225|144376621|SUPERIORITY||LS Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.08||0.0387|TWO_SIDED|95.0|-0.33|-0.01|||Mixed-effects Repeated Measures Model|||Analysis at Week 8. The change from baseline in monthly mean non-menstrual pelvic pain scores was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.||-0.01|-0.33|0.0387
72554441|NCT02354339|144640767|SUPERIORITY|||||||0.604||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of body weight on Irvingia gabonensis group||||0.604
72554442|NCT02354339|144640767|SUPERIORITY|||||||0.35||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of body weight on placebo group||||0.350
72432077|NCT00797225|144376621|SUPERIORITY||LS Mean Difference|-0.28|STANDARD_ERROR_OF_MEAN|0.08||0.0008|TWO_SIDED|95.0|-0.44|-0.12|||Mixed-effects Repeated Measures Model|||Analysis at Week 8. The change from baseline in monthly mean non-menstrual pelvic pain scores was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.||-0.12|-0.44|0.0008
72432078|NCT00797225|144376621|SUPERIORITY||LS Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.08||0.5879|TWO_SIDED|95.0|-0.21|0.12|||Mixed-effects Repeated Measures Model|||Analysis at Week 12. The change from baseline in monthly mean non-menstrual pelvic pain scores was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.||0.12|-0.21|0.5879
72432079|NCT00797225|144376621|SUPERIORITY||LS Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.08||0.6122|TWO_SIDED|95.0|-0.2|0.12|||Mixed-effects Repeated Measures Model|||Analysis at Week 12. The change from baseline in monthly mean non-menstrual pelvic pain scores was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.||0.12|-0.20|0.6122
72469431|NCT01018732|144462514|SUPERIORITY_OR_OTHER||ratio of titer|0.58|||||TWO_SIDED|95.0|0.32|1.05|||ANOVA|||Day 29, Men Y, Pairwise comparison of geometric mean titer||1.05|0.32|
72469432|NCT01018732|144462514|SUPERIORITY_OR_OTHER||ratio of titer|33.0|||||TWO_SIDED|95.0|18.0|60.0|||ANOVA|||Day 29, Men Y, Pairwise comparison of geometric mean titer||60|18|
72554443|NCT02354339|144640768|SUPERIORITY|||||||0.727||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of BMI on Irvingia gabonensis group||||0.727
72554444|NCT02354339|144640768|SUPERIORITY|||||||0.229||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of BMI on placebo group||||0.229
72554445|NCT02354339|144640769|SUPERIORITY|||||||0.151||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of total cholesterol on Irvingia gabonensis group||||0.151
72432080|NCT00797225|144376621|SUPERIORITY||LS Mean Difference|-0.25|STANDARD_ERROR_OF_MEAN|0.08||0.0023|TWO_SIDED|95.0|-0.41|-0.09|||Mixed-effects Repeated Measures Model|||Analysis at Week 12. The change from baseline in monthly mean non-menstrual pelvic pain scores was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.||-0.09|-0.41|0.0023
72554446|NCT02354339|144640769|SUPERIORITY|||||||0.955||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of total cholesterol on placebo group||||0.955
72554447|NCT02354339|144640770|SUPERIORITY|||||||0.35||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of LDL-c on Irvingia gabonensis group||||0.350
72614884|NCT01047501|144759876|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-21.5|||<|0.0001|TWO_SIDED|95.0|-26.7|-16.2||Nonparametric analysis p values were planned using Wilcoxon rank-sum test for each comparison between AMR101 and placebo. Comparisons between AMR101 and placebo were made using a significance level of 0.05.|Wilcoxon rank-sum test|A prespecified step-down testing procedure was used to control Type I error rate using 4 g/day vs placebo then, if significant, 2 g/day vs placebo.|Median differences between the treatment groups and 95% CIs were estimated with the Hodges-Lehmann method.|A sample size of 194 was required to provide 90.6% power to detect a difference of 15% between AMR101 4 g/day and placebo in percent change from baseline in fasting TG levels, assuming an SD of 45% in TG measurements and a significance level (p value) of 0.05, and 80% power to demonstrate noninferiority (p 0.025, 1-sided) of the LDL-cholesterol response between AMR101 4 g/day and placebo with a +6% margin. To accommodate a 10% drop-out rate, recruitment was planned for 648 randomized patients.||-16.2|-26.7|<0.0001
72554448|NCT02354339|144640770|SUPERIORITY|||||||0.47||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of LDL-c on placebo group||||0.470
72554449|NCT02354339|144640771|SUPERIORITY|||||||0.91||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of AST on Irvingia gabonensis group||||0.910
72554450|NCT02354339|144640771|SUPERIORITY|||||||0.436||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of AST on placebo group||||0.436
72554451|NCT02354339|144640772|SUPERIORITY|||||||0.989||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of ALT on Irvingia gabonensis group||||0.989
72432081|NCT00797225|144376622|SUPERIORITY||LS Mean Difference|-0.47|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-0.69|-0.24|||Mixed-effects Repeated Measures Model|||Analysis at Week 4. The change from baseline in monthly mean dysmenorrhea scores was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.||-0.24|-0.69|< 0.0001
72554452|NCT02354339|144640772|SUPERIORITY|||||||0.949||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of ALT on placebo group||||0.949
72554453|NCT02354339|144640773|SUPERIORITY|||||||0.095||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of creatinine on Irvingia gabonensis group||||0.095
72469433|NCT01018732|144462514|SUPERIORITY_OR_OTHER||ratio of titer|19.0|||||TWO_SIDED|95.0|10.0|35.0|||ANOVA|||Day 29, Men Y, Pairwise comparison of geometric mean titer||35|10|
72554454|NCT02354339|144640773|SUPERIORITY|||||||0.401||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of creatinine on placebo group||||0.401
72554455|NCT02354339|144640774|SUPERIORITY|||||||0.91||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of uric acid on Irvingia gabonensis group||||0.910
72554456|NCT02354339|144640774|SUPERIORITY|||||||0.791||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of uric acid on placebo group||||0.791
72554457|NCT01940341|144640779|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Sample sizes of 130 and 260 participants in the TDF group and TAF groups, respectively were planned to give 90% power to rule out the noninferiority margin of 10% at a 1-sided significance level of 0.025. This sample size was based on the assumption that the expected difference (TAF-TDF) in proportion of participants with HBV DNA\<29 IU/mL was 0 and the proportion of participants with HBV DNA\<29 IU/mL in the TDF group was 91%. All missing data were treated as not achieving the primary endpoint.|Difference in proportions|1.8|||||TWO_SIDED|95.0|-3.6|7.2|||||Difference in the proportion between treatment groups and its 95% CI were calculated based on the Mantel-Haenszel (MH) proportions adjusted by baseline HBV DNA categories and oral antiviral treatment status strata.|The null hypothesis was that the TAF group is at least 10% worse than the TDF group with respect to the proportion of participants with HBV DNA \< 29 IU/mL at Week 48. The alternative hypothesis was that the TAF group is less than 10% worse than the TDF group with respect to the proportion of participants with HBV DNA \< 29 IU/mL at Week 48. Noninferiority was assessed using a 95% confidence interval (CI) approach, with a noninferiority margin of 10%.||7.2|-3.6|
72554458|NCT00841698|144640800|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of LS Means x 100|97.34||||||90.0|91.67|103.35|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||103.35|91.67|
72554459|NCT00841698|144640801|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of LS Means x 100|94.46||||||90.0|90.22|98.89|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||98.89|90.22|
72554460|NCT00841698|144640802|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of LS Means x 100|94.83||||||90.0|89.96|99.96|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||99.96|89.96|
72554461|NCT00185458|144640803|SUPERIORITY_OR_OTHER|||||||0.128||95.0|||||Friedman's two-way ANOVA|||Time effect tested with Friedman's two-way analysis of variance (ANOVA). The null-hypothesis is that the means are equal at the reference period tested.||||0.128
72554462|NCT00185458|144640804|SUPERIORITY_OR_OTHER|||||||0.296||95.0|||||Friedman's two-way ANOVA|||Time effect tested with Friedman's two-way analysis of variance (ANOVA). The null-hypothesis is that the means are equal at the reference period tested.||||0.296
72554463|NCT00185458|144640806|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Friedman's two-way ANOVA|||This is a Friedman's two-way analysis of variance (ANOVA) to test the time effect within the treatment group. The null-hypothesis is that the means are equal at the time points tested.||||<0.001
72554464|NCT00185458|144640808|SUPERIORITY_OR_OTHER|||||||0.027||95.0|||||Friedman's two-way ANOVA|||This is a Friedman's two-way analysis of variance (ANOVA) to test the time effect within the treatment group. The null-hypothesis is that the means are equal at the time points tested.||||0.027
72554465|NCT00185458|144640809|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Friedman's two-way ANOVA|||This is a Friedman's two-way analysis of variance (ANOVA) to test the time effect within the treatment group. The null-hypothesis is that the means are equal at the time points tested.||||<0.001
72554466|NCT00185458|144640810|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Friedman's two-way ANOVA|||This is a Friedman's two-way analysis of variance (ANOVA) to test the time effect within the treatment group. The null-hypothesis is that the means are equal at the time points tested.||||<0.001
72554467|NCT00185458|144640811|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Friedman's two-way ANOVA|||This is a Friedman's two-way analysis of variance (ANOVA) to test the time effect within the treatment group. The null-hypothesis is that the means are equal at the time points tested.||||<0.001
72554468|NCT00185458|144640812|SUPERIORITY_OR_OTHER|||||||0.054||95.0|||||Friedman's two-way ANOVA|||This is a Friedman's two-way analysis of variance (ANOVA) to test the time effect within the treatment group. The null-hypothesis is that the means are equal at the time points tested.||||0.054
72554469|NCT00185458|144640813|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Friedman's two-way ANOVA|||This is a Friedman's two-way analysis of variance (ANOVA) to test the time effect within the treatment group. The null-hypothesis is that the means are equal at the time points tested.||||<0.001
72554470|NCT00185458|144640814|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Friedman's two-way ANOVA|||This is a Friedman's two-way analysis of variance (ANOVA) to test the time effect within the treatment group. The null-hypothesis is that the means are equal at the time points tested.||||<0.001
72554471|NCT00185458|144640815|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Friedman's two-way ANOVA|||This is a Friedman's two-way analysis of variance (ANOVA) to test the time effect within the treatment group. The null-hypothesis is that the means are equal at the time points tested.||||<0.001
72554472|NCT00185458|144640816|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Friedman's two-way ANOVA|||This is a Friedman's two-way analysis of variance (ANOVA) to test the time effect within the treatment group. The null-hypothesis is that the means are equal at the time points tested.||||<0.001
72554473|NCT00185458|144640817|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Friedman's two-way ANOVA|||This is a Friedman's two-way analysis of variance (ANOVA) to test the time effect within the treatment group. The null-hypothesis is that the means are equal at the time points tested.||||<0.001
72554474|NCT00185458|144640818|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Friedman's two-way ANOVA|||This is a Friedman's two-way analysis of variance (ANOVA) to test the time effect within the treatment group. The null-hypothesis is that the means are equal at the time points tested.||||<0.001
72554475|NCT00185458|144640819|SUPERIORITY_OR_OTHER|||||||0.175||95.0|||||Friedman's two-way ANOVA|||This is a Friedman's two-way analysis of variance (ANOVA) to test the time effect within the treatment group. The null-hypothesis is that the means are equal at the time points tested.||||0.175
72554476|NCT00185458|144640820|SUPERIORITY_OR_OTHER|||||||0.062||95.0|||||Friedman's two-way ANOVA|||This is a Friedman's two-way analysis of variance (ANOVA) to test the time effect within the treatment group. The null-hypothesis is that the means are equal at the time points tested.||||0.062
72554477|NCT00185458|144640821|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Friedman's two-way ANOVA|||This is a Friedman's two-way analysis of variance (ANOVA) to test the time effect within the treatment group. The null-hypothesis is that the means are equal at the time points tested.||||<0.001
72554478|NCT01249651|144640857|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilocoxon signed-rank test|||Wilcoxon signed-rank test was used to check whether the change in the frequency of heartburn during the 7-day period prior to the 8 week visit (Visit 3) compared to the frequency of heartburn during the 7-day period prior to baseline (Visit 1) was statistically significant or not.||||<0.001
72554479|NCT01581658|144640862|SUPERIORITY_OR_OTHER||Geometric mean ratio|128.82|||||TWO_SIDED|90.0|105.962|156.604|||ANOVA|The model includes fixed effect for the renal function group||||156.604|105.962|
72554480|NCT01581658|144640862|SUPERIORITY_OR_OTHER||Geometric mean ratio|143.82|||||TWO_SIDED|90.0|118.306|174.848|||ANOVA|The model includes fixed effect for the renal function group||||174.848|118.306|
72554481|NCT01581658|144640862|SUPERIORITY_OR_OTHER||Geometric mean ratio|152.31|||||TWO_SIDED|90.0|125.287|185.166|||ANOVA|The model includes fixed effect for the renal function group||||185.166|125.287|
72554482|NCT01581658|144640863|SUPERIORITY_OR_OTHER||Geometric mean ratio|93.5|||||TWO_SIDED|90.0|72.236|121.015|||ANOVA|The model includes fixed effect for the renal function group||||121.015|72.236|
72554483|NCT01581658|144640863|SUPERIORITY_OR_OTHER||Geometric mean ratio|92.18|||||TWO_SIDED|90.0|71.216|119.305|||ANOVA|The model includes fixed effect for the renal function group||||119.305|71.216|
72554484|NCT01581658|144640863|SUPERIORITY_OR_OTHER||Geometric mean ratio|94.01|||||TWO_SIDED|90.0|72.63|121.674|||ANOVA|The model includes fixed effect for the renal function group||||121.674|72.630|
72554485|NCT02538523|144640866|SUPERIORITY||||||<|0.005|||||||Fisher Exact|||A Fischer's Exact Test for two independent proportions was conducted to compare the statistical significance of the 44.8% difference in proportion of successes between procedure groups at two-months post-procedure (study endpoint) relative to baseline evaluation.||||<0.005
72554486|NCT02538523|144640867|SUPERIORITY||||||<|0.05|||||||ANCOVA|||Differences is the statistical significance of change scores in ODI total score from study baseline to endpoint (two-months post-procedure) were evaluated by Analysis of Covariance (ANCOVA), with change from baseline to endpoint in ODI total score as the dependent variable, baseline ODI total score as the covariate and procedure group (Erchonia FX-635 or placebo laser) as a main effect.||||<0.05
72554487|NCT00787254|144640935|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.251|||<|0.0001|TWO_SIDED|95.0|0.14|0.4499|||Log Rank|||||0.4499|0.1400|<0.0001
72554488|NCT00787254|144640936|SUPERIORITY_OR_OTHER|||||||0.0002||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0002
72554489|NCT00787254|144640937|SUPERIORITY_OR_OTHER|||||||0.0041||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0041
72554490|NCT00787254|144640938|SUPERIORITY_OR_OTHER|||||||0.0652||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0652
72554491|NCT00787254|144640939|SUPERIORITY_OR_OTHER|||||||0.9836||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.9836
72554492|NCT00787254|144640941|SUPERIORITY_OR_OTHER|||||||0.0001||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0001
72554493|NCT00787254|144640942|SUPERIORITY_OR_OTHER|||||||0.0161||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0161
72554494|NCT00787254|144640943|SUPERIORITY_OR_OTHER|||||||0.0068||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0068
72554495|NCT00787254|144640944|SUPERIORITY_OR_OTHER|||||||0.2363||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.2363
72554496|NCT00787254|144640946|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Log Rank|||||||<0.0001
72554497|NCT00787254|144640947|SUPERIORITY_OR_OTHER|||||||0.4788||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.4788
72554498|NCT00787254|144640948|SUPERIORITY_OR_OTHER|||||||0.6607||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.6607
72554499|NCT00787254|144640949|SUPERIORITY_OR_OTHER|||||||0.8811||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.8811
72554500|NCT00787254|144640950|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Wilcoxon (Mann-Whitney)|||||||1.0000
72554501|NCT00787254|144640952|SUPERIORITY_OR_OTHER|||||||0.206||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.2060
72554502|NCT00787254|144640953|SUPERIORITY_OR_OTHER|||||||0.5099||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.5099
72554503|NCT00787254|144640954|SUPERIORITY_OR_OTHER|||||||0.7794||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.7794
72554504|NCT00787254|144640955|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Wilcoxon (Mann-Whitney)|||||||1.0000
72554505|NCT00787254|144640957|SUPERIORITY_OR_OTHER|||||||0.698||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.6980
72554506|NCT00787254|144640958|SUPERIORITY_OR_OTHER|||||||0.4599||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.4599
72554507|NCT00787254|144640959|SUPERIORITY_OR_OTHER|||||||0.0355||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0355
72554508|NCT00787254|144640960|SUPERIORITY_OR_OTHER|||||||0.7325||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.7325
72554509|NCT00787254|144640962|SUPERIORITY_OR_OTHER|||||||0.8262||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.8262
72554510|NCT00787254|144640963|SUPERIORITY_OR_OTHER|||||||0.7244||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.7244
72554511|NCT00787254|144640964|SUPERIORITY_OR_OTHER|||||||0.9566||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.9566
72554512|NCT00787254|144640965|SUPERIORITY_OR_OTHER|||||||0.2008||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.2008
72554513|NCT00787254|144640967|SUPERIORITY_OR_OTHER|||||||0.0703||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0703
72554514|NCT00787254|144640968|SUPERIORITY_OR_OTHER|||||||0.3046||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.3046
72554515|NCT00787254|144640969|SUPERIORITY_OR_OTHER|||||||0.7121||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.7121
72554516|NCT00787254|144640970|SUPERIORITY_OR_OTHER|||||||0.1522||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.1522
72554517|NCT00787254|144640972|SUPERIORITY_OR_OTHER|||||||0.5328||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.5328
72554518|NCT00787254|144640973|SUPERIORITY_OR_OTHER|||||||0.7223||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.7223
72554519|NCT00787254|144640974|SUPERIORITY_OR_OTHER|||||||0.3117||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.3117
72554520|NCT00787254|144640975|SUPERIORITY_OR_OTHER|||||||0.4344||95.0|||||t-test, 2 sided|||||||0.4344
72554521|NCT00787254|144640977|SUPERIORITY_OR_OTHER|||||||0.1571||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.1571
72554522|NCT00787254|144640978|SUPERIORITY_OR_OTHER|||||||0.2503||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.2503
72554523|NCT00787254|144640979|SUPERIORITY_OR_OTHER|||||||0.4028||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.4028
72554524|NCT00787254|144640980|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Wilcoxon (Mann-Whitney)|||||||1.0000
72554525|NCT00859430|144641055|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Ratio of Geometric Means|105.0||||||90.0|98.6|112.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||112|98.6|
72554526|NCT00859430|144641056|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Ratio of Geometric Means|98.6||||||90.0|96.2|101.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||101|96.2|
72554527|NCT00859430|144641057|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Ratio of Geometric Means|98.4||||||90.0|95.9|101.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||101|95.9|
72565296|NCT01715896|144662060|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|1.06||||0.752|TWO_SIDED|90.0|0.79|1.41|||Repeated measures model||An estimate of the treatment difference and its 90% CI was computed by means of repeated measures model including terms for baseline as a continuous covariate and treatment as a factor was used for the analysis.|||1.41|0.79|0.752
72565297|NCT01715896|144662061|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|1.05||||0.725|TWO_SIDED|90.0|0.84|1.3|||Repeated measures model||An estimate of the treatment difference and its 90% CI was computed by means of repeated measures model including terms for baseline as a continuous covariate and treatment as a factor was used for the analysis.|||1.30|0.84|0.725
72565298|NCT03923699|144662072|SUPERIORITY||Risk Ratio (RR)|0.96||||0.41|TWO_SIDED|95.0|0.85|1.08||Not adjusted for multiple comparisons.|Regression, Poisson|||||1.08|0.85|0.41
72565299|NCT03923699|144662073|SUPERIORITY||Risk Ratio (RR)|1.0||||0.92|TWO_SIDED|95.0|0.92|1.1||Not adjusted for multiple comparisons.|Regression, Poisson|||||1.10|0.92|0.92
72554528|NCT02925884|144641059|SUPERIORITY|||||||0.011|||||||Mixed Models Analysis|||Null hypothesis: No difference between the Gunnar OTC Condition and the Control Condition on the factor score of Decreased Cognitive Functions.||||0.011
72554529|NCT02925884|144641059|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||Null hypothesis: No difference between the Gunnar OTC Condition and the Control Condition on the factor score of Eyestrain.||||<0.001
72554530|NCT02925884|144641059|SUPERIORITY|||||||0.009|||||||Mixed Models Analysis|||Null hypothesis: No difference between the Gunnar OTC Condition and the Control Condition on the factor score of Physical Discomfort.||||0.009
72554531|NCT02925884|144641059|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||Null hypothesis: No difference between the Gunnar OTC Condition and the Control Condition on the factor score of Deceased Visual Function.||||<0.001
72554532|NCT02925884|144641059|SUPERIORITY|||||||0.28|||||||Mixed Models Analysis|||Null hypothesis: No difference between the Gunnar OTC Condition and the Control Condition on the factor score of Poor Balance.||||0.28
72554533|NCT02925884|144641060|SUPERIORITY|||||||0.903|||||||Mixed Models Analysis|||||||0.903
72554534|NCT02925884|144641061|SUPERIORITY|||||||0.009|||||||Mixed Models Analysis|||Null hypothesis: No difference between the Gunna OTC Glasses condition and the Control condition on Red Color Perception.||||0.009
72554535|NCT02925884|144641061|SUPERIORITY|||||||0.446|||||||Mixed Models Analysis|||Null hypothesis: No difference between the Gunna OTC Glasses condition and the Control condition on Green Color Perception.||||0.446
72554536|NCT02925884|144641061|SUPERIORITY|||||||0.953|||||||Mixed Models Analysis|||Null hypothesis: No difference between the Gunna OTC Glasses condition and the Control condition on Blue Color Perception.||||0.953
72554537|NCT02925884|144641062|SUPERIORITY|||||||0.266|||||||Mixed Models Analysis|||||||0.266
72554538|NCT02925884|144641063|SUPERIORITY|||||||0.424|||||||Mixed Models Analysis|||||||0.424
72554539|NCT02925884|144641064|SUPERIORITY|||||||0.343|||||||Mixed Models Analysis|||||||0.343
72554540|NCT02925884|144641065|SUPERIORITY|||||||0.489|||||||Mixed Models Analysis|||||||0.489
72554541|NCT02925884|144641066|SUPERIORITY|||||||0.885|||||||Mixed Models Analysis|||||||0.885
72554542|NCT02925884|144641067|SUPERIORITY|||||||0.001|||||||Mixed Models Analysis|||||||0.001
72554543|NCT02925884|144641068|SUPERIORITY|||||||0.359|||||||Mixed Models Analysis|||||||0.359
72554544|NCT03635320|144641083|NON_INFERIORITY|non-inferiority margin of -10%|95%CI|0.0|||||TWO_SIDED|95.0|-4.53|4.42|||Newcombe-Wilson scoring method|Using the Newcombe-Wilson scoring method, the difference of fracture union rate between the TFNA group and the PFNA-II group was 0.|If the lower limit of 95% CI of the difference in the rates of the study group and the control group is greater than the non-inferiority margin of -10%, then the investigational product is considered non-inferior to the control product.|||4.42|-4.53|
72554545|NCT00835575|144641097|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|99.52||||||90.0|92.84|106.69|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||106.69|92.84|
72554546|NCT00835575|144641098|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|103.59||||||90.0|99.13|108.25|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||108.25|99.13|
72554547|NCT00835575|144641099|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|103.87||||||90.0|99.47|108.46|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||108.46|99.47|
72554548|NCT04383587|144641100|SUPERIORITY||||||>|0.18|||||||Fisher Exact|||Participants were grouped by age (18-35 vs. 36-50 vs. 51-65 vs. \>65), Sex at birth (Female vs. Male). and Occupational Role (Technician vs Anesthesiologist vs Advanced Practice Provider vs. Attendant Aide vs. CRNA vs. OR nurse vs Perfusionist vs Surgeon).||||>0.18
72554549|NCT00567320|144641102|SUPERIORITY_OR_OTHER_LEGACY|||||||0.84|TWO_SIDED|95.0|||||Mixed Models Analysis|||HLM analysis of % of Cocaine Positive Urines per week over 12 weeks. Subjects were used as a Random variable, with medication dosing set to 'Fixed'.||||0.84
72554550|NCT02849457|144641107|SUPERIORITY||Mean Difference (Final Values)|-0.6565|STANDARD_ERROR_OF_MEAN|3.9332||0.8681|TWO_SIDED|95.0|-8.5567|7.2436|||Mixed Models Analysis|Adjusted for age (\<=7 vs \>7 months) at randomization and sex. Unstructured covariance used among 12 and 24 month outcomes.|Parameter represents estimated amount difference in group means. Negative value represents higher mean in placebo group.|||7.2436|-8.5567|0.8681
72554551|NCT02849457|144641108|SUPERIORITY|||||||0.7375|||||||Chi-squared|||||||0.7375
72554552|NCT02849457|144641109|SUPERIORITY||Hazard Ratio (HR)|0.593||||0.1174|TWO_SIDED|95.0|0.309|1.14|||Regression, Cox|Adjusted for age (\<=7 vs \>7 months) at randomization and sex.||||1.140|0.309|0.1174
72554553|NCT02849457|144641110|OTHER|Two-sided test of non-equivalence||||||0.4653|||||||Chi-squared|||||||0.4653
72554554|NCT02849457|144641111|SUPERIORITY||Mean Difference (Final Values)|-4.4392|STANDARD_ERROR_OF_MEAN|3.1889||0.1697|TWO_SIDED|95.0|-10.8346|1.9562|||Mixed Models Analysis|Adjusted for age at randomization (\<=7 vs \>7 months) and sex. Unstructured covariance used among 12, 24, and 36 month outcomes.|Pertains to the estimated difference in mean score between groups at study visit corresponding to 24 months of age.|||1.9562|-10.8346|0.1697
72554555|NCT03673670|144641123|OTHER|A hierarchical fixed-sequence testing strategy was employed to test the significance of the treatment effect for each of the two RPL554 doses against placebo, starting with the highest dose (6 mg). If a statistically significant difference was found at the 2-sided α level of 5%, the testing proceeded with the next highest dose. Otherwise, testing was stopped, and the remaining null hypotheses were accepted without testing.|GeoMean Ratio|1.021||||0.168|TWO_SIDED|95.0|0.991|1.052|||ANCOVA|||||1.052|0.991|0.168
72565300|NCT03923699|144662074|SUPERIORITY||Risk Ratio (RR)|0.98||||0.68|TWO_SIDED|95.0|0.89|1.09||Not adjusted for multiple comparisons.|Regression, Poisson|||||1.09|0.89|0.68
72565301|NCT03923699|144662075|SUPERIORITY||Risk Ratio (RR)|0.98||||0.42|TWO_SIDED|95.0|0.92|1.05||Not adjusted for multiple comparisons.|Regression, Poisson|||||1.05|0.92|0.42
72554556|NCT03673670|144641123|OTHER|A hierarchical fixed-sequence testing strategy was employed to test the significance of the treatment effect for each of the two RPL554 doses against placebo, starting with the highest dose (6 mg). If a statistically significant difference was found at the 2-sided α level of 5%, the testing proceeded with the next highest dose. Otherwise, testing was stopped, and the remaining null hypotheses were accepted without testing.|GeoMean Ratio|0.995||||0.731|TWO_SIDED|95.0|0.966|1.025|||ANCOVA|||||1.025|0.966|0.731
72554557|NCT03673670|144641124|OTHER|A hierarchical fixed-sequence testing strategy was employed to test the significance of the treatment effect for each of the two RPL554 doses against placebo, starting with the highest dose (6 mg). If a statistically significant difference was found at the 2-sided α level of 5%, the testing proceeded with the next highest dose. Otherwise, testing was stopped, and the remaining null hypotheses were accepted without testing.|GeoMean Ratio|1.024||||0.115|TWO_SIDED|95.0|0.994|1.055|||ANCOVA|||||1.055|0.994|0.115
72554558|NCT03673670|144641124|OTHER|A hierarchical fixed-sequence testing strategy was employed to test the significance of the treatment effect for each of the two RPL554 doses against placebo, starting with the highest dose (6 mg). If a statistically significant difference was found at the 2-sided α level of 5%, the testing proceeded with the next highest dose. Otherwise, testing was stopped, and the remaining null hypotheses were accepted without testing.|GeoMean Ratio|1.024||||0.111|TWO_SIDED|95.0|0.994|1.055|||ANCOVA|||||1.055|0.994|0.111
72554559|NCT03673670|144641125|OTHER|A hierarchical fixed-sequence testing strategy was employed to test the significance of the treatment effect for each of the two RPL554 doses against placebo, starting with the highest dose (6 mg). If a statistically significant difference was found at the 2-sided α level of 5%, the testing proceeded with the next highest dose. Otherwise, testing was stopped, and the remaining null hypotheses were accepted without testing.|GeoMean Ratio|1.014||||0.303|TWO_SIDED|95.0|0.987|1.043|||ANCOVA|||||1.043|0.987|0.303
72554560|NCT03673670|144641126|OTHER|A hierarchical fixed-sequence testing strategy was employed to test the significance of the treatment effect for each of the two RPL554 doses against placebo, starting with the highest dose (6 mg). If a statistically significant difference was found at the 2-sided α level of 5%, the testing proceeded with the next highest dose. Otherwise, testing was stopped, and the remaining null hypotheses were accepted without testing.|GeoMean Ratio|1.027||||0.067|TWO_SIDED|95.0|0.998|1.057|||ANCOVA|||||1.057|0.998|0.067
72554561|NCT03673670|144641126|OTHER|A hierarchical fixed-sequence testing strategy was employed to test the significance of the treatment effect for each of the two RPL554 doses against placebo, starting with the highest dose (6 mg). If a statistically significant difference was found at the 2-sided α level of 5%, the testing proceeded with the next highest dose. Otherwise, testing was stopped, and the remaining null hypotheses were accepted without testing.|GeoMean Ratio|1.012||||0.395|TWO_SIDED|95.0|0.984|1.042|||ANCOVA|||||1.042|0.984|0.395
72554562|NCT03673670|144641127|OTHER|A hierarchical fixed-sequence testing strategy was employed to test the significance of the treatment effect for each of the two RPL554 doses against placebo, starting with the highest dose (6 mg). If a statistically significant difference was found at the 2-sided α level of 5%, the testing proceeded with the next highest dose. Otherwise, testing was stopped, and the remaining null hypotheses were accepted without testing.|GeoMean Ratio|1.012||||0.404|TWO_SIDED|95.0|0.984|1.039|||ANCOVA|||||1.039|0.984|0.404
72554563|NCT03673670|144641128|OTHER|A hierarchical fixed-sequence testing strategy was employed to test the significance of the treatment effect for each of the two RPL554 doses against placebo, starting with the highest dose (6 mg). If a statistically significant difference was found at the 2-sided α level of 5%, the testing proceeded with the next highest dose. Otherwise, testing was stopped, and the remaining null hypotheses were accepted without testing.|GeoMean Ratio|1.082||||0.001|TWO_SIDED|95.0|1.043|1.123|||ANCOVA|||||1.123|1.043|0.001
72554564|NCT03673670|144641128|OTHER|A hierarchical fixed-sequence testing strategy was employed to test the significance of the treatment effect for each of the two RPL554 doses against placebo, starting with the highest dose (6 mg). If a statistically significant difference was found at the 2-sided α level of 5%, the testing proceeded with the next highest dose. Otherwise, testing was stopped, and the remaining null hypotheses were accepted without testing.|GeoMean Ratio|1.061||||0.002|TWO_SIDED|95.0|1.023|1.101|||ANCOVA|||||1.101|1.023|0.002
72554565|NCT03673670|144641129|OTHER|A hierarchical fixed-sequence testing strategy was employed to test the significance of the treatment effect for each of the two RPL554 doses against placebo, starting with the highest dose (6 mg). If a statistically significant difference was found at the 2-sided α level of 5%, the testing proceeded with the next highest dose. Otherwise, testing was stopped, and the remaining null hypotheses were accepted without testing.|GeoMean Ratio|1.02||||0.096|TWO_SIDED|95.0|0.997|1.043|||ANCOVA|||||1.043|0.997|0.096
72554566|NCT03673670|144641129|OTHER|A hierarchical fixed-sequence testing strategy was employed to test the significance of the treatment effect for each of the two RPL554 doses against placebo, starting with the highest dose (6 mg). If a statistically significant difference was found at the 2-sided α level of 5%, the testing proceeded with the next highest dose. Otherwise, testing was stopped, and the remaining null hypotheses were accepted without testing.|GeoMean Ratio|1.002||||0.862|TWO_SIDED|95.0|0.979|1.025|||ANCOVA|||||1.025|0.979|0.862
72554567|NCT03673670|144641130|OTHER||Median Difference (Final Values)|0.0||||0.945|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.945
72554568|NCT03673670|144641130|OTHER||Median Difference (Final Values)|0.0||||0.501|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.501
72554569|NCT00575159|144641180|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-2.728||||0.0008|TWO_SIDED|95.0|-4.219|-1.236|||ANCOVA|||Difference from placebo to GSK189075 50mg AUC(0-4) Incremental Adjusted Weighted Mean||-1.236|-4.219|0.0008
72554570|NCT00575159|144641180|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.325||||0.0021|TWO_SIDED|95.0|-3.735|-0.916|||ANCOVA|||Difference from placebo toGSK189075 150mg AUC(0-4) Incremental Adjusted Weighted Mean||-0.916|-3.735|0.0021
72554571|NCT00575159|144641180|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.402||||0.0021|TWO_SIDED|95.0|-3.862|-0.942|||ANCOVA|||Difference from placebo to GSK189075 500mg AUC(0-4) Incremental Adjusted Weighted Mean||-0.942|-3.862|0.0021
72554572|NCT00575159|144641180|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.556||||0.0382|TWO_SIDED|95.0|0.09|3.021|||ANCOVA|||Difference from Placebo+ Prandial insulin to GSK189075 50mg AUC(0-4) Incremental Adjusted Weighted Mean||3.021|0.090|0.0382
72554573|NCT00575159|144641180|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.958||||0.0132|TWO_SIDED|95.0|0.439|3.477|||ANCOVA|||Difference from Placebo+ Prandial insulin to GSK189075 150mg AUC(0-4) Incremental Adjusted Weighted Mean||3.477|0.439|0.0132
72554574|NCT00575159|144641180|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.881||||0.0161|TWO_SIDED|95.0|0.373|3.389|||ANCOVA|||Difference from Placebo+ Prandial insulin to GSK189075 500mg AUC(0-4) Incremental Adjusted Weighted Mean||3.389|0.373|0.0161
72554575|NCT00575159|144641180|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.592||||0.0001|TWO_SIDED|95.0|-5.162|-2.022|||ANCOVA|||Difference from placebo to GSK189075 50mg AUC(0-10) Incremental Adjusted Weighted Mean||-2.022|-5.162|0.0001
72554576|NCT00575159|144641180|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.82||||0|TWO_SIDED|95.0|-5.304|-2.337|||ANCOVA|||Difference from placebo to GSK189075 150mg AUC(0-10) Incremental Adjusted Weighted Mean||-2.337|-5.304|0.0000
72554577|NCT00575159|144641180|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.887||||0.0006|TWO_SIDED|95.0|-4.424|-1.35|||ANCOVA|||Difference from placebo to GSK189075 500mg AUC(0-10) Incremental Adjusted Weighted Mean||-1.350|-4.424|0.0006
72554578|NCT00575159|144641180|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.953||||0.0005|TWO_SIDED|95.0|1.411|4.496|||ANCOVA|||Difference from Placebo+ Prandial insulin to GSK189075 50mg AUC(0-10) Incremental Adjusted Weighted Mean||4.496|1.411|0.0005
72554579|NCT00575159|144641180|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.725||||0.0015|TWO_SIDED|95.0|1.126|4.324|||ANCOVA|||Difference from Placebo+ Prandial insulin to GSK189075 150mg AUC(0-10) Incremental Adjusted Weighted Mean||4.324|1.126|0.0015
72554580|NCT00575159|144641180|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.659||||0.0001|TWO_SIDED|95.0|2.071|5.246|||ANCOVA|||Difference from Placebo+ Prandial insulin to GSK189075 500mg AUC(0-10) Incremental Adjusted Weighted Mean||5.246|2.071|0.0001
72554581|NCT03733444|144641192|SUPERIORITY||Least Squares (LS) Mean difference|2.8|STANDARD_ERROR_OF_MEAN|25.29||0.9123|TWO_SIDED|95.0|-46.9|52.4||P-value was based on random coefficient regression model (linear slope model) on FVC values.|Coefficient Regression Model|Treatment effect was determined by using estimated slopes for each treatment group on basis of time-by-treatment interaction term from mixed model.||||52.4|-46.9|0.9123
72554582|NCT03733444|144641192|SUPERIORITY||LS Mean difference|1.7|STANDARD_ERROR_OF_MEAN|25.01||0.9456|TWO_SIDED|95.0|-47.4|50.8||P-value was based on random coefficient regression model (linear slope model) on FVC values.|Coefficient Regression Model|Treatment effect was determined by using estimated slopes for each treatment group on basis of time-by-treatment interaction term from mixed model.||||50.8|-47.4|0.9456
72554583|NCT03733444|144641193|SUPERIORITY||Odds Ratio (OR)|1.15||||0.5162|TWO_SIDED|95.0|0.76|1.74|||Regression, Logistic|||||1.74|0.76|0.5162
72554584|NCT03733444|144641193|SUPERIORITY||Odds Ratio (OR)|1.07||||0.7566|TWO_SIDED|95.0|0.71|1.62|||Regression, Logistic|||||1.62|0.71|0.7566
72554585|NCT03733444|144641194|SUPERIORITY||Hazard Ratio (HR)|2.15|||||TWO_SIDED|95.0|1.2|3.85|||||Hazard ratio and 95% confidence interval originated from a Cox proportional hazards model for time to first respiratory-related hospitalization.|||3.85|1.20|
72554586|NCT03733444|144641194|SUPERIORITY||Hazard Ratio (HR)|1.69|||||TWO_SIDED|95.0|0.93|3.1|||||Hazard ratio and 95% confidence interval originated from a Cox proportional hazards model for time to first respiratory-related hospitalization.|||3.10|0.93|
72554587|NCT03733444|144641195|SUPERIORITY||LS Mean difference|-0.1||||0.937|TWO_SIDED|95.0|-3.2|3.0||LS mean difference (95% CI) per treatment group with treatment, time (categorical), treatment-by-time interaction, stratum and baseline SGRQ total score as fixed effects and participant as random effect.|Mixed Models Analysis|||||3.0|-3.2|0.9370
72554588|NCT03733444|144641195|SUPERIORITY||LS Mean difference|-0.4||||0.8064|TWO_SIDED|95.0|-3.4|2.7||LS mean difference (95% CI) per treatment group with treatment, time (categorical), treatment-by-time interaction, stratum and baseline SGRQ total score as fixed effects and participant as random effect.|Mixed Models Analysis|||||2.7|-3.4|0.8064
72554589|NCT03733444|144641196|SUPERIORITY||LS Mean difference|2.9|STANDARD_ERROR_OF_MEAN|23.39|||TWO_SIDED|95.0|-41.1|46.8|||||The treatment effect was determined by using estimated slopes for each study group on the basis of the time-by-treatment interaction term from the mixed model.|||46.8|-41.1|
72554590|NCT03733444|144641196|SUPERIORITY||LS Mean difference|8.0|STANDARD_ERROR_OF_MEAN|22.16|||TWO_SIDED|95.0|-35.5|51.5|||||The treatment effect was determined by using estimated slopes for each study group on the basis of the time-by-treatment interaction term from the mixed model.|||51.5|-35.5|
72554591|NCT03733444|144641197|SUPERIORITY||Odds Ratio (OR)|1.32|||||TWO_SIDED|95.0|0.9|1.94|||||Odds ratio and 95% confidence interval originated from a logistic regression.|||1.94|0.90|
72554592|NCT03733444|144641197|SUPERIORITY||Odds Ratio (OR)|1.06|||||TWO_SIDED|95.0|0.72|1.56|||||Odds ratio and 95% confidence interval originated from a logistic regression.|||1.56|0.72|
72554593|NCT03733444|144641198|SUPERIORITY||LS Mean difference|0.9|||||TWO_SIDED|95.0|-12.4|14.1|||||The treatment effect was determined by using estimated least square mean difference between each active treatment group and placebo from the mixed model.|||14.1|-12.4|
72554594|NCT03733444|144641198|SUPERIORITY||LS Mean difference|3.6|||||TWO_SIDED|95.0|-10.4|17.6|||||The treatment effect was determined by using estimated least square mean difference between each active treatment group and placebo from the mixed model.|||17.6|-10.4|
72554595|NCT03733444|144641199|SUPERIORITY||Hazard Ratio (HR)|1.54|||||TWO_SIDED|95.0|1.01|2.35|||||Hazard ratio and 95% confidence interval originated from a Cox proportional hazards model for time to first all cause hospitalization.|||2.35|1.01|
72554596|NCT03733444|144641199|SUPERIORITY||Hazard Ratio (HR)|1.4|||||TWO_SIDED|95.0|0.91|2.16|||||Hazard ratio and 95% confidence interval originated from a Cox proportional hazards model for time to all cause hospitalization.|||2.16|0.91|
72554597|NCT03733444|144641202|SUPERIORITY||Hazard Ratio (HR)|2.92|||||TWO_SIDED|95.0|1.04|8.14|||||Hazard ratio and 95% confidence interval originated from a Cox proportional hazards model for time to first acute IPF exacerbation.|||8.14|1.04|
72554598|NCT03733444|144641202|SUPERIORITY||Hazard Ratio (HR)|1.68|||||TWO_SIDED|95.0|0.55|5.13|||||Hazard ratio and 95% confidence interval originated from a Cox proportional hazards model for time to first acute IPF exacerbation.|||5.13|0.55|
72554599|NCT03733444|144641203|SUPERIORITY||Hazard Ratio (HR)|2.27|||||TWO_SIDED|95.0|1.06|4.82|||||Hazard ratio and 95% confidence interval originated from a Cox proportional hazards model for time to first all cause mortality or hospitalization for non-elective lung transplant.|||4.82|1.06|
72554600|NCT03733444|144641203|SUPERIORITY||Hazard Ratio (HR)|1.87|||||TWO_SIDED|95.0|0.86|4.06|||||Hazard ratio and 95% confidence interval originated from a Cox proportional hazards model for time to first all cause mortality or hospitalization for non-elective lung transplant.|||4.06|0.86|
72554601|NCT03733444|144641204|SUPERIORITY||Hazard Ratio (HR)|2.27|||||TWO_SIDED|95.0|1.06|4.82|||||Hazard ratio and 95% confidence interval originated from a Cox proportional hazards model for time to first all cause mortality, hospitalization for non-elective lung transplant or hospitalization for qualifying for lung transplant.|||4.82|1.06|
72554602|NCT03733444|144641204|SUPERIORITY||Hazard Ratio (HR)|1.87|||||TWO_SIDED|95.0|0.86|4.06|||||Hazard ratio and 95% confidence interval originated from a Cox proportional hazards model for time to first all cause mortality, hospitalization for non-elective lung transplant or hospitalization for qualifying for lung transplant.|||4.06|0.86|
72469434|NCT01056263|144462624|SUPERIORITY_OR_OTHER||Five year survival probability|20.6|||||TWO_SIDED|95.0|10.94|32.38||||||Five year survival probability was the probability of survival at 5 year after the date of the start of the study treatment based on the Kaplan-Meier estimate.||32.38|10.94|
72554603|NCT03733444|144641205|SUPERIORITY||Hazard Ratio (HR)|1.99|||||TWO_SIDED|95.0|1.2|3.31|||||Hazard ratio and 95% confidence interval originated from a Cox proportional hazards model for time to first all-cause mortality or hospitalization that meets \>=10% absolute decline in %FVC or respiratory-related hospitalization.|||3.31|1.20|
72554604|NCT03733444|144641205|SUPERIORITY||Hazard Ratio (HR)|1.49|||||TWO_SIDED|95.0|0.88|2.54|||||Hazard ratio and 95% confidence interval originated from a Cox proportional hazards model for time to first all-cause mortality or hospitalization that meets \>=10% absolute decline in %FVC or respiratory-related hospitalization.|||2.54|0.88|
72554605|NCT03733444|144641206|SUPERIORITY||Hazard Ratio (HR)|1.99|||||TWO_SIDED|95.0|1.2|3.31|||||Hazard ratio and 95% confidence interval originated from a Cox proportional hazards model for time to first all-cause mortality or respiratory-related hospitalizations.|||3.31|1.20|
72554606|NCT03733444|144641206|SUPERIORITY||Hazard Ratio (HR)|1.49|||||TWO_SIDED|95.0|0.88|2.54|||||Hazard ratio and 95% confidence interval originated from a Cox proportional hazards model for time to first all-cause mortality or respiratory-related hospitalizations.|||2.54|0.88|
72554607|NCT00556322|144641228|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.96||||0.7299|TWO_SIDED|95.0|0.78|1.19|||Log Rank|||||1.19|0.78|0.7299
72554608|NCT00556322|144641231|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.94||||0.6198|TWO_SIDED|95.0|0.72|1.21|||Log Rank|||Comparison of EGFR positive populations||1.21|0.72|0.6198
72554609|NCT00556322|144641231|SUPERIORITY_OR_OTHER||Hazard Ratio, log|0.95||||0.8398|TWO_SIDED|95.0|0.55|1.62|||Log Rank|||Comparison of EGFR negative populations||1.62|0.55|0.8398
72554610|NCT00556322|144641234|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.19||||0.0885|TWO_SIDED|95.0|0.97|1.46|||Log Rank|||||1.46|0.97|0.0885
72554611|NCT00556322|144641237|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.26||||0.0662|TWO_SIDED|95.0|0.98|1.61|||Log Rank|||Comparison of EGFR positive populations||1.61|0.98|0.0662
72554612|NCT00556322|144641237|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.02||||0.9403|TWO_SIDED|95.0|0.61|1.69|||Log Rank|||Comparison of EGFR negative populations||1.69|0.61|0.9403
72554613|NCT00556322|144641239|SUPERIORITY_OR_OTHER||Difference in Response Rates|1.55||||0.5349|TWO_SIDED|95.0|-3.6|6.7||p-values are based on non-stratified analysis|Chi-squared||Approximate 95% CI for the difference of two rates was determined using Hauck-Anderson Method|||6.7|-3.6|0.5349
72554614|NCT00556322|144641241|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.21||||0.1498|TWO_SIDED|95.0|0.93|1.59|||Log Rank|||||1.59|0.93|0.1498
72554615|NCT00556322|144641244|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.19||||0.2202|TWO_SIDED|95.0|0.9|1.57|||Log Rank|||||1.57|0.90|0.2202
72554616|NCT00556322|144641247|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.25||||0.1063|TWO_SIDED|95.0|0.95|1.66|||Log Rank|||||1.66|0.95|0.1063
72554617|NCT04813354|144641277|SUPERIORITY||Odds Ratio (OR)|0.11|||<|0.001|TWO_SIDED|95.0|0.01|0.4|||Exact conditional logistic regression||Odds ratio between ELLIPTA DPI and BREEZHALER DPI was calculated using an exact conditional logistic regression model with participant as fixed strata, inhaler and period as fixed effects.|||0.40|0.01|<0.001
72554618|NCT04813354|144641279|OTHER||Odds Ratio (OR)|0.25||||0.005|TWO_SIDED|95.0|0.03|0.74|||Exact conditional logistic regression||Odds ratio between ELLIPTA DPI and BREEZHALER DPI was calculated using an exact conditional logistic regression model with participant as fixed strata, inhaler and period as fixed effects.|||0.74|0.03|0.005
72554619|NCT04813354|144641288|OTHER||Mean Difference (Final Values)|27.63|||<|0.001|TWO_SIDED|95.0|21.31|33.96|||Paired samples t-test|||||33.96|21.31|<0.001
72554620|NCT02964039|144641312|SUPERIORITY|||||||0.047||||||A priori threshold: 0.05|ANOVA|0.047 is the main effect of group from a 2-way ANOVA that also included time (p=0.77) as a within-subjects factor.||||||0.047
72554621|NCT02964039|144641313|SUPERIORITY|||||||0.16||||||A priori threshold: 0.05|ANOVA|0.16 is the main effect of group from a 2-way ANOVA that also included time (p=0.023) as a within-subjects factor.||||||0.16
72554622|NCT02964039|144641314|SUPERIORITY|||||||0.64||||||A priori threshold: 0.05|ANOVA|0.64 is the main effect of group from a 2-way ANOVA that also included time (p=0.024) as a within-subjects factor.||||||0.64
72554623|NCT02964039|144641315|SUPERIORITY|||||||0.92||||||A priori threshold: 0.92|ANOVA|0.92 is the main effect of group from a 2-way ANOVA that also included time (p=0.076) as a within-subjects factor.||||||0.92
72554624|NCT02964039|144641316|SUPERIORITY||||||>=|0.22||||||A priori threshold: 0.05|Mixed Models Analysis|We compared incident rates assuming a negative binomial distribution with leas squares means estimates predicted via generalized linear model.||||||>=0.22
72554625|NCT02964039|144641317|SUPERIORITY|||||||0.99||||||A priori threshold: 0.05|Chi-squared|||||||0.99
72554626|NCT01172145|144641318|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.385|STANDARD_ERROR_OF_MEAN|4.86||0.181|TWO_SIDED|95.0|-16.86|3.4|||t-test, 2 sided|||||3.40|-16.86|0.181
72554627|NCT00796653|144641326|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.129|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.091|0.167|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.167|0.091|<0.0001
72554628|NCT00796653|144641326|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.154|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.116|0.191|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.191|0.116|<0.0001
72565302|NCT03923699|144662076|SUPERIORITY||Risk Ratio (RR)|1.0||||0.99|TWO_SIDED|95.0|0.98|1.02||Not adjusted for multiple comparisons.|Regression, Poisson|||||1.02|0.98|0.99
72554629|NCT00796653|144641326|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.15|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.112|0.188|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.188|0.112|<0.0001
72554630|NCT00796653|144641327|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.053|STANDARD_ERROR_OF_MEAN|0.019||0.0055||95.0|0.015|0.09|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.090|0.015|0.0055
72554631|NCT00796653|144641327|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.069|STANDARD_ERROR_OF_MEAN|0.019||0.0003||95.0|0.032|0.106|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.106|0.032|0.0003
72554632|NCT00796653|144641327|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.042|STANDARD_ERROR_OF_MEAN|0.019||0.027||95.0|0.005|0.08|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.080|0.005|0.0270
72554633|NCT00796653|144641328|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.402|STANDARD_ERROR_OF_MEAN|0.314||0.1999||95.0|-0.213|1.018|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||1.018|-0.213|0.1999
72554634|NCT00796653|144641328|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.419|STANDARD_ERROR_OF_MEAN|0.314||0.1818||95.0|-0.196|1.035|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||1.035|-0.196|0.1818
72554635|NCT00796653|144641328|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.602|STANDARD_ERROR_OF_MEAN|0.316||0.0572||95.0|-0.019|1.222|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||1.222|-0.019|0.0572
72554636|NCT00796653|144641329|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.15|STANDARD_ERROR_OF_MEAN|1.349||0.0197||95.0|-5.796|-0.503|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||-0.503|-5.796|0.0197
72554637|NCT00796653|144641329|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.524|STANDARD_ERROR_OF_MEAN|1.354||0.0094||95.0|-6.18|-0.867|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||-0.867|-6.180|0.0094
72554638|NCT00796653|144641329|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.416|STANDARD_ERROR_OF_MEAN|1.365||0.2995||95.0|-4.093|1.261|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||1.261|-4.093|0.2995
72554639|NCT00796653|144641330|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.352|STANDARD_ERROR_OF_MEAN|1.385||0.7995||95.0|-3.068|2.365|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||2.365|-3.068|0.7995
72554640|NCT00796653|144641330|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.09|STANDARD_ERROR_OF_MEAN|1.391||0.4336||95.0|-3.818|1.639|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||1.639|-3.818|0.4336
72554641|NCT00796653|144641330|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.111|STANDARD_ERROR_OF_MEAN|1.395||0.9365||95.0|-2.625|2.848|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||2.848|-2.625|0.9365
72554642|NCT00796653|144641331|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.625|STANDARD_ERROR_OF_MEAN|1.333||0.0491||95.0|-5.241|-0.01|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||-0.010|-5.241|0.0491
72554643|NCT00796653|144641331|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.489|STANDARD_ERROR_OF_MEAN|1.341||0.0636||95.0|-5.119|0.141|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.141|-5.119|0.0636
72554644|NCT00796653|144641331|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.158|STANDARD_ERROR_OF_MEAN|1.35||0.0194||95.0|-5.806|-0.511|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||-0.511|-5.806|0.0194
72554645|NCT00796653|144641332|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.846|STANDARD_ERROR_OF_MEAN|0.972||0.0034|TWO_SIDED|95.0|-4.751|-0.94|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect||Olo 5 mcg minus placebo||-0.940|-4.751|0.0034
72554646|NCT00796653|144641332|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.434|STANDARD_ERROR_OF_MEAN|0.973||0.0004|TWO_SIDED|95.0|-5.343|-1.525|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect||Olo 10 mcg minus placebo||-1.525|-5.343|0.0004
72565303|NCT03923699|144662077|SUPERIORITY||Risk Ratio (RR)|1.0||||0.95|TWO_SIDED|95.0|0.95|1.05||Not adjusted for multiple comparisons.|Regression, Poisson|||||1.05|0.95|0.95
72432082|NCT00797225|144376622|SUPERIORITY||LS mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-0.73|-0.27|||Mixed-effects Repeated Measures Model|||Analysis at Week 4. The change from baseline in monthly mean dysmenorrhea scores was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.||-0.27|-0.73|< 0.0001
72554647|NCT00796653|144641332|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.248|STANDARD_ERROR_OF_MEAN|0.976||0.2009|TWO_SIDED|95.0|-3.161|0.665|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect||Form 12 mcg minus placebo||0.665|-3.161|0.2009
72554648|NCT00796653|144641333|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.16|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.123|0.196|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.196|0.123|<0.0001
72554649|NCT00796653|144641333|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.193|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.157|0.229|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.229|0.157|<0.0001
72554650|NCT00796653|144641333|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.162|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.126|0.199|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.199|0.126|<0.0001
72554651|NCT00796653|144641334|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.172|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.136|0.209|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.209|0.136|<0.0001
72554652|NCT00796653|144641334|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.192|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.155|0.228|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.228|0.155|<0.0001
72554653|NCT00796653|144641334|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.184|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.148|0.221|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.221|0.148|<0.0001
72554654|NCT00796653|144641335|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.145|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.108|0.182|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.182|0.108|<0.0001
72554655|NCT00796653|144641335|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.175|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.138|0.212|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.212|0.138|<0.0001
72554656|NCT00796653|144641335|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.17|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.133|0.208|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.208|0.133|<0.0001
72554657|NCT00796653|144641336|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.118|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001||95.0|0.08|0.156|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.156|0.080|<0.0001
72554658|NCT00796653|144641336|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.141|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001||95.0|0.103|0.18|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.180|0.103|<0.0001
72554659|NCT00796653|144641336|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.129|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001||95.0|0.091|0.168|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.168|0.091|<0.0001
72554660|NCT00796653|144641337|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.069|STANDARD_ERROR_OF_MEAN|0.018||0.0002||95.0|0.033|0.105|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.105|0.033|0.0002
72554661|NCT00796653|144641337|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.119|STANDARD_ERROR_OF_MEAN|0.018|<|0.0001||95.0|0.083|0.155|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.155|0.083|<0.0001
72614885|NCT01047501|144759876|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-10.1||||0.0005|TWO_SIDED|95.0|-15.7|-4.5|||Wilcoxon rank-sum test||Median differences between the treatment groups and 95% CIs were estimated with the Hodges-Lehmann method.|||-4.5|-15.7|0.0005
72554662|NCT00796653|144641337|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.049|STANDARD_ERROR_OF_MEAN|0.018||0.0071||95.0|0.013|0.085|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.085|0.013|0.0071
72554663|NCT00796653|144641338|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.084|STANDARD_ERROR_OF_MEAN|0.018|<|0.0001||95.0|0.048|0.12|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.120|0.048|<0.0001
72554664|NCT00796653|144641338|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.104|STANDARD_ERROR_OF_MEAN|0.018|<|0.0001||95.0|0.068|0.141|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.141|0.068|<0.0001
72554665|NCT00796653|144641338|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.07|STANDARD_ERROR_OF_MEAN|0.018||0.0001||95.0|0.034|0.106|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.106|0.034|0.0001
72554666|NCT00796653|144641339|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.059|STANDARD_ERROR_OF_MEAN|0.019||0.0017||95.0|0.022|0.095|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.095|0.022|0.0017
72554667|NCT00796653|144641339|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.093|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.057|0.13|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.130|0.057|<0.0001
72554668|NCT00796653|144641339|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.065|STANDARD_ERROR_OF_MEAN|0.019||0.0005||95.0|0.028|0.101|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.101|0.028|0.0005
72554669|NCT00796653|144641340|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.019||0.0085||95.0|0.013|0.087|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.087|0.013|0.0085
72554670|NCT00796653|144641340|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.086|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.049|0.122|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.122|0.049|<0.0001
72554671|NCT00796653|144641340|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.051|STANDARD_ERROR_OF_MEAN|0.019||0.0067||95.0|0.014|0.088|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.088|0.014|0.0067
72554672|NCT00796653|144641341|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.062|STANDARD_ERROR_OF_MEAN|0.019||0.0012||95.0|0.025|0.1|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.100|0.025|0.0012
72554673|NCT00796653|144641341|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.073|STANDARD_ERROR_OF_MEAN|0.019||0.0002||95.0|0.035|0.11|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.110|0.035|0.0002
72554674|NCT00796653|144641341|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.048|STANDARD_ERROR_OF_MEAN|0.019||0.0117||95.0|0.011|0.086|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.086|0.011|0.0117
72554675|NCT00796653|144641342|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.062|STANDARD_ERROR_OF_MEAN|0.019||0.0014||95.0|0.024|0.099|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.099|0.024|0.0014
72554676|NCT00796653|144641342|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.084|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.047|0.122|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.122|0.047|<0.0001
72554677|NCT00796653|144641342|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.056|STANDARD_ERROR_OF_MEAN|0.019||0.0035||95.0|0.019|0.094|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.094|0.019|0.0035
72554678|NCT00796653|144641343|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.044|STANDARD_ERROR_OF_MEAN|0.019||0.0228||95.0|0.006|0.082|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.082|0.006|0.0228
72504973|NCT01462292|144541157|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.412||||0.523|TWO_SIDED|95.0|-1.702|0.878||No adjustment for multiplicity was made, so p-values should not be used to make conclusions with regards to statistical significance|ANCOVA|Model included terms for treatment, centre grouping and baseline||Placebo (combined) Vs GSK2402968 6 mg/kg/week, Descent Week 24||0.878|-1.702|0.523
72554679|NCT00796653|144641343|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.059|STANDARD_ERROR_OF_MEAN|0.019||0.0024||95.0|0.021|0.097|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.097|0.021|0.0024
72554680|NCT00796653|144641343|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.036|STANDARD_ERROR_OF_MEAN|0.019||0.0664||95.0|-0.002|0.074|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.074|-0.002|0.0664
72554681|NCT00796653|144641344|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.161|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.122|0.199|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.199|0.122|<0.0001
72554682|NCT00796653|144641344|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.178|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.14|0.216|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.216|0.140|<0.0001
72554683|NCT00796653|144641344|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.153|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.115|0.191|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.191|0.115|<0.0001
72554684|NCT00796653|144641345|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.168|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001||95.0|0.13|0.207|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.207|0.130|<0.0001
72554685|NCT00796653|144641345|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.181|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001||95.0|0.143|0.22|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.220|0.143|<0.0001
72554686|NCT00796653|144641345|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.176|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001||95.0|0.137|0.214|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.214|0.137|<0.0001
72554687|NCT00796653|144641346|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.141|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001||95.0|0.103|0.18|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.180|0.103|<0.0001
72554688|NCT00796653|144641346|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.168|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001||95.0|0.129|0.207|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.207|0.129|<0.0001
72554689|NCT00796653|144641346|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.164|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001||95.0|0.125|0.203|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.203|0.125|<0.0001
72554690|NCT00796653|144641347|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.123|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001||95.0|0.084|0.163|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.163|0.084|<0.0001
72554691|NCT00796653|144641347|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.151|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001||95.0|0.112|0.191|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.191|0.112|<0.0001
72622163|NCT04003142|144774326|SUPERIORITY||Odds Ratio (OR)|3.536||||0.002||95.0|1.666|8.207||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 11||8.207|1.666|0.002
72504974|NCT01462292|144541158|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.564||||0.05|TWO_SIDED|95.0|0.0|1.127||No adjustment for multiplicity was made, so p-values should not be used to make conclusions with regards to statistical significance|ANCOVA|Model included terms for treatment, centre grouping and baseline||Treatment difference: Placebo Vs GSK2402968 3 mg||1.127|0.000|0.050
72554692|NCT00796653|144641347|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.143|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001||95.0|0.104|0.183|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.183|0.104|<0.0001
72554693|NCT00796653|144641348|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.112|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001||95.0|0.071|0.152|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.152|0.071|<0.0001
72554694|NCT00796653|144641348|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.126|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001||95.0|0.086|0.166|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.166|0.086|<0.0001
72554695|NCT00796653|144641348|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.118|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001||95.0|0.078|0.158|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.158|0.078|<0.0001
72554696|NCT00796653|144641349|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.231|STANDARD_ERROR_OF_MEAN|0.035|<|0.0001||95.0|0.162|0.299|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.299|0.162|<0.0001
72554697|NCT00796653|144641349|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.25|STANDARD_ERROR_OF_MEAN|0.035|<|0.0001||95.0|0.182|0.318|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.318|0.182|<0.0001
72554698|NCT00796653|144641349|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.266|STANDARD_ERROR_OF_MEAN|0.035|<|0.0001||95.0|0.198|0.334|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.334|0.198|<0.0001
72554699|NCT00796653|144641350|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.251|STANDARD_ERROR_OF_MEAN|0.035|<|0.0001||95.0|0.182|0.32|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.320|0.182|<0.0001
72554700|NCT00796653|144641350|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.249|STANDARD_ERROR_OF_MEAN|0.035|<|0.0001||95.0|0.18|0.318|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.318|0.180|<0.0001
72554701|NCT00796653|144641350|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.281|STANDARD_ERROR_OF_MEAN|0.035|<|0.0001||95.0|0.212|0.35|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.350|0.212|<0.0001
72554702|NCT00796653|144641351|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.229|STANDARD_ERROR_OF_MEAN|0.036|<|0.0001||95.0|0.159|0.299|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.299|0.159|<0.0001
72554703|NCT00796653|144641351|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.247|STANDARD_ERROR_OF_MEAN|0.035|<|0.0001||95.0|0.177|0.317|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.317|0.177|<0.0001
72554704|NCT00796653|144641351|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.275|STANDARD_ERROR_OF_MEAN|0.036|<|0.0001||95.0|0.205|0.345|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.345|0.205|<0.0001
72554705|NCT00796653|144641352|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.199|STANDARD_ERROR_OF_MEAN|0.036|<|0.0001||95.0|0.128|0.27|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.270|0.128|<0.0001
72554706|NCT00796653|144641352|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.213|STANDARD_ERROR_OF_MEAN|0.036|<|0.0001||95.0|0.142|0.283|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.283|0.142|<0.0001
72554707|NCT00796653|144641352|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.241|STANDARD_ERROR_OF_MEAN|0.036|<|0.0001||95.0|0.17|0.312|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.312|0.170|<0.0001
72554708|NCT00796653|144641353|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.218|STANDARD_ERROR_OF_MEAN|0.037|<|0.0001||95.0|0.146|0.29|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.290|0.146|<0.0001
72554709|NCT00796653|144641353|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.237|STANDARD_ERROR_OF_MEAN|0.037|<|0.0001||95.0|0.166|0.309|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.309|0.166|<0.0001
72554710|NCT00796653|144641353|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.22|STANDARD_ERROR_OF_MEAN|0.037|<|0.0001||95.0|0.148|0.292|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.292|0.148|<0.0001
72554711|NCT00796653|144641354|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.088|STANDARD_ERROR_OF_MEAN|0.035||0.0133||95.0|0.018|0.157|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.157|0.018|0.0133
72554712|NCT00796653|144641354|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.143|STANDARD_ERROR_OF_MEAN|0.035|<|0.0001||95.0|0.073|0.212|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.212|0.073|<0.0001
72554713|NCT00796653|144641354|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.082|STANDARD_ERROR_OF_MEAN|0.035||0.0212||95.0|0.012|0.151|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.151|0.012|0.0212
72554714|NCT00796653|144641355|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.127|STANDARD_ERROR_OF_MEAN|0.036||0.0004||95.0|0.057|0.197|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.197|0.057|0.0004
72554715|NCT00796653|144641355|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.115|STANDARD_ERROR_OF_MEAN|0.036||0.0012||95.0|0.045|0.185|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.185|0.045|0.0012
72554716|NCT00796653|144641355|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.099|STANDARD_ERROR_OF_MEAN|0.036||0.0056||95.0|0.029|0.169|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.169|0.029|0.0056
72554717|NCT00796653|144641356|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.103|STANDARD_ERROR_OF_MEAN|0.036||0.0045||95.0|0.032|0.173|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.173|0.032|0.0045
72554718|NCT00796653|144641356|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.102|STANDARD_ERROR_OF_MEAN|0.036||0.0046||95.0|0.032|0.173|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.173|0.032|0.0046
72554719|NCT00796653|144641356|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.11|STANDARD_ERROR_OF_MEAN|0.036||0.0023||95.0|0.039|0.181|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.181|0.039|0.0023
72554720|NCT00796653|144641357|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.097|STANDARD_ERROR_OF_MEAN|0.037||0.0077||95.0|0.026|0.169|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.169|0.026|0.0077
72554721|NCT00796653|144641357|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.121|STANDARD_ERROR_OF_MEAN|0.036||0.0009||95.0|0.05|0.193|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.193|0.050|0.0009
72554722|NCT00796653|144641357|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.078|STANDARD_ERROR_OF_MEAN|0.037||0.0339||95.0|0.006|0.149|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.149|0.006|0.0339
72554723|NCT00796653|144641358|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.066|STANDARD_ERROR_OF_MEAN|0.037||0.0718||95.0|-0.006|0.139|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.139|-0.006|0.0718
72554724|NCT00796653|144641358|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.063|STANDARD_ERROR_OF_MEAN|0.037||0.0863||95.0|-0.009|0.135|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.135|-0.009|0.0863
72554725|NCT00796653|144641358|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.038|STANDARD_ERROR_OF_MEAN|0.037||0.2982||95.0|-0.034|0.111|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.111|-0.034|0.2982
72554726|NCT00796653|144641359|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.087|STANDARD_ERROR_OF_MEAN|0.037||0.019||95.0|0.014|0.16|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.160|0.014|0.0190
72554727|NCT00796653|144641359|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.07|STANDARD_ERROR_OF_MEAN|0.037||0.0601||95.0|-0.003|0.143|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.143|-0.003|0.0601
72554728|NCT00796653|144641359|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.042|STANDARD_ERROR_OF_MEAN|0.037||0.2573||95.0|-0.031|0.115|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.115|-0.031|0.2573
72554729|NCT00796653|144641360|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.087|STANDARD_ERROR_OF_MEAN|0.037||0.02||95.0|0.014|0.16|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.160|0.014|0.0200
72554730|NCT00796653|144641360|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.121|STANDARD_ERROR_OF_MEAN|0.037||0.0013||95.0|0.047|0.194|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.194|0.047|0.0013
72554731|NCT00796653|144641360|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.053|STANDARD_ERROR_OF_MEAN|0.037||0.1598||95.0|-0.021|0.126|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.126|-0.021|0.1598
72554732|NCT00796653|144641361|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.081|STANDARD_ERROR_OF_MEAN|0.038||0.0307||95.0|0.008|0.155|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.155|0.008|0.0307
72554733|NCT00796653|144641361|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.101|STANDARD_ERROR_OF_MEAN|0.038||0.0073||95.0|0.027|0.175|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.175|0.027|0.0073
72432083|NCT00797225|144376622|SUPERIORITY||LS Mean Difference|-0.48|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-0.71|-0.25|||Mixed-effects Repeated Measures Model|||Analysis at Week 4. The change from baseline in monthly mean dysmenorrhea scores was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.||-0.25|-0.71|< 0.0001
72432084|NCT00797225|144376622|SUPERIORITY||LS Mean Difference|-0.46|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-0.69|-0.23|||Mixed-effects Repeated Measures Model|||Analysis at Week 8. The change from baseline in monthly mean dysmenorrhea scores was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.||-0.23|-0.69|< 0.0001
72554734|NCT00796653|144641361|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.038|STANDARD_ERROR_OF_MEAN|0.038||0.3147||95.0|-0.036|0.112|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.112|-0.036|0.3147
72554735|NCT00796653|144641362|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.233|STANDARD_ERROR_OF_MEAN|0.037|<|0.0001||95.0|0.16|0.306|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.306|0.160|<0.0001
72554736|NCT00796653|144641362|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.229|STANDARD_ERROR_OF_MEAN|0.037|<|0.0001||95.0|0.156|0.302|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.302|0.156|<0.0001
72554737|NCT00796653|144641362|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.248|STANDARD_ERROR_OF_MEAN|0.037|<|0.0001||95.0|0.175|0.321|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.321|0.175|<0.0001
72554738|NCT00796653|144641363|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.247|STANDARD_ERROR_OF_MEAN|0.038|<|0.0001||95.0|0.174|0.321|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.321|0.174|<0.0001
72554739|NCT00796653|144641363|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.221|STANDARD_ERROR_OF_MEAN|0.037|<|0.0001||95.0|0.148|0.295|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.295|0.148|<0.0001
72554740|NCT00796653|144641363|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.254|STANDARD_ERROR_OF_MEAN|0.038|<|0.0001||95.0|0.18|0.328|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.328|0.180|<0.0001
72554741|NCT00796653|144641364|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.215|STANDARD_ERROR_OF_MEAN|0.038|<|0.0001||95.0|0.141|0.289|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.289|0.141|<0.0001
72554742|NCT00796653|144641364|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.226|STANDARD_ERROR_OF_MEAN|0.038|<|0.0001||95.0|0.151|0.3|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.300|0.151|<0.0001
72554743|NCT00796653|144641364|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.265|STANDARD_ERROR_OF_MEAN|0.038|<|0.0001||95.0|0.191|0.34|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.340|0.191|<0.0001
72554744|NCT00796653|144641365|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.182|STANDARD_ERROR_OF_MEAN|0.039|<|0.0001||95.0|0.106|0.258|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.258|0.106|<0.0001
72554745|NCT00796653|144641365|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.18|STANDARD_ERROR_OF_MEAN|0.038|<|0.0001||95.0|0.105|0.256|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.256|0.105|<0.0001
72554746|NCT00796653|144641365|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.207|STANDARD_ERROR_OF_MEAN|0.039|<|0.0001||95.0|0.132|0.283|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.283|0.132|<0.0001
72554747|NCT00796653|144641366|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.188|STANDARD_ERROR_OF_MEAN|0.039|<|0.0001||95.0|0.111|0.265|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.265|0.111|<0.0001
72554748|NCT00796653|144641366|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.214|STANDARD_ERROR_OF_MEAN|0.039|<|0.0001||95.0|0.138|0.291|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.291|0.138|<0.0001
72554749|NCT00796653|144641366|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.192|STANDARD_ERROR_OF_MEAN|0.039|<|0.0001||95.0|0.115|0.269|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.269|0.115|<0.0001
72554750|NCT00796653|144641367|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.707|STANDARD_ERROR_OF_MEAN|4.435||0.0021|TWO_SIDED|95.0|5.004|22.411|||ANCOVA|non-MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.||Comparison for weekly mean daytime rescue use||22.411|5.004|0.0021
72554751|NCT00796653|144641367|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|20.871|STANDARD_ERROR_OF_MEAN|4.44|<|0.0001|TWO_SIDED|95.0|12.158|29.584|||ANCOVA|non-MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.||Comparison for weekly mean daytime rescue use||29.584|12.158|<0.0001
72554752|NCT00796653|144641367|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.249|STANDARD_ERROR_OF_MEAN|4.454||0.0014|TWO_SIDED|95.0|5.506|22.991|||ANCOVA|non-MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.||Comparison for weekly mean daytime rescue use||22.991|5.506|0.0014
72554753|NCT00796653|144641367|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|17.4|STANDARD_ERROR_OF_MEAN|4.463||0.0001|TWO_SIDED|95.0|8.64|26.16|||ANCOVA|non-MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.||Comparison for weekly mean nighttime rescue use||26.160|8.640|0.0001
72554754|NCT00796653|144641367|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|22.875|STANDARD_ERROR_OF_MEAN|4.444|<|0.0001|TWO_SIDED|95.0|14.153|31.596|||ANCOVA|non-MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.||Comparison for weekly mean nighttime rescue use||31.596|14.153|<0.0001
72554755|NCT00796653|144641367|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|15.816|STANDARD_ERROR_OF_MEAN|4.475||0.0004|TWO_SIDED|95.0|7.032|24.599|||ANCOVA|non-MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.||Comparison for weekly mean nighttime rescue use||24.599|7.032|0.0004
72554756|NCT00796653|144641368|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.153|STANDARD_ERROR_OF_MEAN|0.121||0.2057|TWO_SIDED|95.0|-0.391|-0.084|||ANCOVA|non-MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.||Comparison for weekly mean daytime rescue use||-0.084|-0.391|0.2057
72554757|NCT00796653|144641368|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.266|STANDARD_ERROR_OF_MEAN|0.121||0.0284|TWO_SIDED|95.0|-0.504|-0.028|||ANCOVA|non-MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.||Comparison for weekly mean daytime rescue use||-0.028|-0.504|0.0284
72554758|NCT00796653|144641368|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.222|STANDARD_ERROR_OF_MEAN|0.122||0.0685|TWO_SIDED|95.0|-0.461|0.017|||ANCOVA|non-MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.||Comparison for weekly mean daytime rescue use||0.017|-0.461|0.0685
72554759|NCT00796653|144641368|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.278|STANDARD_ERROR_OF_MEAN|0.152||0.0674|TWO_SIDED|95.0|-0.576|0.02|||ANCOVA|non-MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.||Comparison for weekly mean nighttime rescue use||0.020|-0.576|0.0674
72554760|NCT00796653|144641368|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.365|STANDARD_ERROR_OF_MEAN|0.0163||0.0163|TWO_SIDED|95.0|-0.662|-0.067|||ANCOVA|non-MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.||Comparison for weekly mean nighttime rescue use||-0.067|-0.662|0.0163
72432085|NCT00797225|144376622|SUPERIORITY||LS mean Difference|-0.64|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-0.87|-0.4|||Mixed-effects Repeated Measures Model|||Analysis at Week 8. The change from baseline in monthly mean dysmenorrhea scores was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.||-0.40|-0.87|< 0.0001
72554761|NCT00796653|144641368|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.32|STANDARD_ERROR_OF_MEAN|0.153||0.0364|TWO_SIDED|95.0|-0.62|-0.02|||ANCOVA|non-MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.||Comparison for weekly mean nighttime rescue use||-0.020|-0.620|0.0364
72554762|NCT00796653|144641368|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.424|STANDARD_ERROR_OF_MEAN|0.254||0.0959|TWO_SIDED|95.0|-0.922|0.075|||ANCOVA|non-MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.||Comparison for weekly mean daily (24h) rescue use||0.075|-0.922|0.0959
72554763|NCT00796653|144641368|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.616|STANDARD_ERROR_OF_MEAN|0.254||0.0155|TWO_SIDED|95.0|-1.115|-0.117|||ANCOVA|non-MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.||Comparison for weekly mean daily (24h) rescue use||-0.117|-1.115|0.0155
72554764|NCT00796653|144641368|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.541|STANDARD_ERROR_OF_MEAN|0.256||0.0347|TWO_SIDED|95.0|-1.042|-0.039|||ANCOVA|non-MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.||Comparison for weekly mean daily (24h) rescue use||-0.039|-1.042|0.0347
72554765|NCT00796653|144641369|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.1||0.0164||95.0|-0.4|0.0|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects, patient as random effect|Olo 5 mcg qd minus Placebo|||-0.0|-0.4|0.0164
72554766|NCT00796653|144641369|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.1||0.0196||95.0|-0.4|0.0|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects, patient as random effect|Olo 10 mcg qd minus Placebo|||-0.0|-0.4|0.0196
72554767|NCT00796653|144641369|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.1||0.0041||95.0|-0.5|-0.1|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects, patient as random effect|Form 12 mcg minus Placebo|||-0.1|-0.5|0.0041
72554768|NCT00796653|144641370|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.1||0.0388||95.0|-0.4|0.0|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects, patient as random effect|Olo 5 mcg qd minus Placebo|||-0.0|-0.4|0.0388
72554769|NCT00796653|144641370|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.1||0.0038||95.0|-0.5|-0.1|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects, patient as random effect|Olo 10 mcg qd minus Placebo|||-0.1|-0.5|0.0038
72554770|NCT00796653|144641370|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.1||0.0053||95.0|-0.5|-0.1|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects, patient as random effect|Form 12 mcg minus Placebo|||-0.1|-0.5|0.0053
72554771|NCT00796653|144641371|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.1||0.0555||95.0|-0.4|0.0|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects, patient as random effect|Olo 5 mcg qd minus Placebo|||0.0|-0.4|0.0555
72554772|NCT00796653|144641371|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.1||0.0122||95.0|-0.4|-0.1|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects, patient as random effect|Olo 10 mcg qd minus Placebo|||-0.1|-0.4|0.0122
72554773|NCT00796653|144641371|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.1||0.0144||95.0|-0.4|-0.1|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects, patient as random effect|Form 12 mcg minus Placebo|||-0.1|-0.4|0.0144
72554774|NCT00796653|144641372|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.1||0.5707||95.0|-0.3|0.1|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects, patient as random effect|Olo 5 mcg qd minus Placebo|||0.1|-0.3|0.5707
72554775|NCT00796653|144641372|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.1||0.0814||95.0|-0.4|0.0|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects, patient as random effect|Olo 10 mcg qd minus Placebo|||0.0|-0.4|0.0814
72554776|NCT00796653|144641372|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.1||0.7413||95.0|-0.2|0.2|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects, patient as random effect|Form 12 mcg minus Placebo|||0.2|-0.2|0.7413
72554777|NCT00796653|144641373|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.437|STANDARD_ERROR_OF_MEAN|0.305||0.1524||95.0|-0.162|1.036|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||1.036|-0.162|0.1524
72554778|NCT00796653|144641373|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.706|STANDARD_ERROR_OF_MEAN|0.306||0.0211||95.0|0.106|1.307|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||1.307|0.106|0.0211
72554779|NCT00796653|144641373|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.464|STANDARD_ERROR_OF_MEAN|0.307||0.1314||95.0|-0.139|1.066|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||1.066|-0.139|0.1314
72554780|NCT00796653|144641374|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.662|STANDARD_ERROR_OF_MEAN|0.308||0.0319||95.0|0.057|1.267|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||1.267|0.057|0.0319
72554781|NCT00796653|144641374|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.667|STANDARD_ERROR_OF_MEAN|0.31||0.0312||95.0|0.06|1.274|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||1.274|0.060|0.0312
72554782|NCT00796653|144641374|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.419|STANDARD_ERROR_OF_MEAN|0.311||0.1777||95.0|-0.191|1.029|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||1.029|-0.191|0.1777
72554783|NCT00796653|144641375|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.425|STANDARD_ERROR_OF_MEAN|0.311||0.1714||95.0|-0.184|1.035|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||1.035|-0.184|0.1714
72554784|NCT00796653|144641375|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.492|STANDARD_ERROR_OF_MEAN|0.312||0.1142||95.0|-0.119|1.103|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||1.103|-0.119|0.1142
72554785|NCT00796653|144641375|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.534|STANDARD_ERROR_OF_MEAN|0.314||0.0888||95.0|-0.081|1.15|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||1.150|-0.081|0.0888
72554786|NCT00796653|144641376|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.49|STANDARD_ERROR_OF_MEAN|0.318||0.1235||95.0|-0.134|1.113|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||1.113|-0.134|0.1235
72554787|NCT00796653|144641376|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.354|STANDARD_ERROR_OF_MEAN|0.318||0.2666||95.0|-0.271|0.978|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.978|-0.271|0.2666
72554788|NCT00796653|144641376|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.309|STANDARD_ERROR_OF_MEAN|0.319||0.3335||95.0|-0.317|0.934|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.934|-0.317|0.3335
72554789|NCT00796653|144641377|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.313|STANDARD_ERROR_OF_MEAN|0.32||0.3287||95.0|-0.315|0.941|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.941|-0.315|0.3287
72554790|NCT00796653|144641377|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.481|STANDARD_ERROR_OF_MEAN|0.321||0.1341||95.0|-0.148|1.109|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||1.109|-0.148|0.1341
72554791|NCT00796653|144641377|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.114|STANDARD_ERROR_OF_MEAN|0.322||0.722||95.0|-0.516|0.745|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.745|-0.516|0.7220
72554792|NCT00796653|144641378|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.397|STANDARD_ERROR_OF_MEAN|0.322||0.2176||95.0|-0.234|1.027|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||1.027|-0.234|0.2176
72554793|NCT00796653|144641378|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.718|STANDARD_ERROR_OF_MEAN|0.323||0.0258||95.0|0.087|1.348|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||1.348|0.087|0.0258
72554794|NCT00796653|144641378|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.167|STANDARD_ERROR_OF_MEAN|0.323||0.6044||95.0|-0.466|0.8|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.800|-0.466|0.6044
72554795|NCT00796653|144641379|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.802|STANDARD_ERROR_OF_MEAN|0.133||0.1946||95.0|0.58|1.111|||Log Rank|Model included a stratification factor for tiotropium use stratum and a covariate for treatment group|Comparison of Olo 5 mcg qd to placebo across stratum|||1.111|0.580|0.1946
72554796|NCT00796653|144641379|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.872|STANDARD_ERROR_OF_MEAN|0.141||0.4071||95.0|0.634|1.198|||Log Rank|Model included a stratification factor for tiotropium use stratum and a covariate for treatment group|Comparison of Olo 10 mcg qd to placebo across stratum|||1.198|0.634|0.4071
72554797|NCT00796653|144641379|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.922|STANDARD_ERROR_OF_MEAN|0.15||0.6404||95.0|0.67|1.267|||Log Rank|Model included a stratification factor for tiotropium use stratum and a covariate for treatment group|Comparison of Form 12 mcg to placebo across stratum|||1.267|0.670|0.6404
72554798|NCT00796653|144641380|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.685|STANDARD_ERROR_OF_MEAN|0.249||0.2942||95.0|0.336|1.399|||Log Rank|Model included a stratification factor for tiotropium use stratum and a covariate for treatment group|Comparison of Olo 5 mcg qd to placebo across stratum|||1.399|0.336|0.2942
72554799|NCT00796653|144641380|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.947|STANDARD_ERROR_OF_MEAN|0.316||0.8594||95.0|0.493|1.82|||Log Rank|Model included a stratification factor for tiotropium use stratum and a covariate for treatment group|Comparison of Olo 10 mcg qd to placebo across stratum|||1.820|0.493|0.8594
72554800|NCT00796653|144641380|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.803|STANDARD_ERROR_OF_MEAN|0.281||0.5466||95.0|0.405|1.593|||Log Rank|Model included a stratification factor for tiotropium use stratum and a covariate for treatment group|Comparison of Form 12 mcg to placebo across stratum|||1.593|0.405|0.5466
72554801|NCT00796653|144641381|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.807|STANDARD_ERROR_OF_MEAN|0.146||0.2494||95.0|0.566|1.15|||Log Rank|Model included a stratification factor for tiotropium use stratum and a covariate for treatment group|Comparison of Olo 5 mcg qd to placebo across stratum|||1.150|0.566|0.2494
72554802|NCT00796653|144641381|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.791|STANDARD_ERROR_OF_MEAN|0.143||0.2006||95.0|0.555|1.126|||Log Rank|Model included a stratification factor for tiotropium use stratum and a covariate for treatment group|Comparison of Olo 10 mcg qd to placebo across stratum|||1.126|0.555|0.2006
72554803|NCT00796653|144641381|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.903|STANDARD_ERROR_OF_MEAN|0.16||0.5795||95.0|0.637|1.279|||Log Rank|Model included a stratification factor for tiotropium use stratum and a covariate for treatment group|Comparison of Form 12 mcg to placebo across stratum|||1.279|0.637|0.5795
72554804|NCT00796653|144641382|SUPERIORITY_OR_OTHER||Incidence rate ratio|0.785|STANDARD_ERROR_OF_MEAN|0.1342||0.1571||95.0|0.5613|1.0979|||Negative binomial regression|Regression of treatment effect using tiotropium strata as a covariate, a log link function and log(exposure) as offset.|Olo 5 mcg qd minus Placebo|||1.0979|0.5613|0.1571
72554805|NCT00796653|144641382|SUPERIORITY_OR_OTHER||Incidence rate ratio|0.8631|STANDARD_ERROR_OF_MEAN|0.1451||0.3814||95.0|0.6205|1.2005|||Negative binomial regression|Regression of treatment effect using tiotropium strata as a covariate, a log link function and log(exposure) as offset.|Olo 10 mcg qd minus Placebo|||1.2005|0.6205|0.3814
72554806|NCT00796653|144641382|SUPERIORITY_OR_OTHER||Incidence rate ratio|1.0631|STANDARD_ERROR_OF_MEAN|0.1748||0.7098||95.0|0.7699|1.468|||Negative binomial regression|Regression of treatment effect using tiotropium strata as a covariate, a log link function and log(exposure) as offset.|Form 12 mcg minus Placebo|||1.4680|0.7699|0.7098
72554807|NCT00796653|144641383|SUPERIORITY_OR_OTHER||Incidence rate ratio|0.7925|STANDARD_ERROR_OF_MEAN|0.2952||0.5326||95.0|0.3814|1.6464|||Negative binomial regression|Regression of treatment effect using tiotropium strata as a covariate, a log link function and log(exposure) as offset.|Olo 5 mcg qd minus Placebo|||1.6464|0.3814|0.5326
72554808|NCT00796653|144641383|SUPERIORITY_OR_OTHER||Incidence rate ratio|1.0078|STANDARD_ERROR_OF_MEAN|0.356||0.9824||95.0|0.5038|2.016|||Negative binomial regression|Regression of treatment effect using tiotropium strata as a covariate, a log link function and log(exposure) as offset.|Olo 10 mcg qd minus Placebo|||2.0160|0.5038|0.9824
72554809|NCT00796653|144641383|SUPERIORITY_OR_OTHER||Incidence rate ratio|1.0403|STANDARD_ERROR_OF_MEAN|0.3681||0.9112||95.0|0.5194|2.0832|||Negative binomial regression|Regression of treatment effect using tiotropium strata as a covariate, a log link function and log(exposure) as offset.|Form 12 mcg minus Placebo|||2.0832|0.5194|0.9112
72614886|NCT01047501|144759877|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Nonparametric analysis p values were planned using Wilcoxon rank-sum test for each comparison between AMR101 and placebo with a significance level of 0.05. Non-inferiority tests for percent change from baseline in LDL-C were performed between AMR101 and placebo to determine if AMR101 was statistically non-inferior to placebo with regard to increases in LDL-C. The pre-specified LDL-C criterion for noninferiority was the upper boundary 97.5% confidence interval not crossing the +6% threshold.|Median Difference (Final Values)|-6.2||||0.0067|TWO_SIDED|95.0|-10.5|-1.7|||Wilcoxon rank-sum test|A prespecified step-down testing procedure was used to control Type I error rate using 4 g/day vs placebo then, if significant, 2 g/day vs placebo.|Median differences between the treatment groups and 95% CIs were estimated with the Hodges-Lehmann method.|A sample size of 194 was required to provide 90.6% power to detect a difference of 15% between AMR101 4 g/day and placebo in percent change from baseline in fasting TG levels, assuming an SD of 45% in TG measurements and a significance level (p value) of 0.05, and 80% power to demonstrate noninferiority (p 0.025, 1-sided) of the LDL-cholesterol response between AMR101 4 g/day and placebo with a +6% margin. To accommodate a 10% drop-out rate, recruitment was planned for 648 randomized patients.||-1.7|-10.5|0.0067
72614887|NCT01047501|144759877|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Nonparametric analysis p values were planned using Wilcoxon rank-sum test for each comparison between AMR101 and placebo with a significance level of 0.05. Non-inferiority tests for percent change from baseline in LDL-C were performed between AMR101 and placebo to determine if AMR101 was statistically non-inferior to placebo with regard to increases in LDL-C. The pre-specified LDL-C criterion for noninferiority was the upper boundary 97.5% confidence interval not crossing the +6% threshold.|Median Difference (Final Values)|-3.6||||0.0867|TWO_SIDED|95.0|-7.9|0.5|||Wilcoxon rank-sum test||Median differences between the treatment groups and 95% CIs were estimated with the Hodges-Lehmann method.|||0.5|-7.9|0.0867
72614888|NCT01047501|144759878|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-13.6||||0.0001|TWO_SIDED|95.0|-17.2|-9.9||Nonparametric analysis p values were planned using Wilcoxon rank-sum test for each comparison between AMR101 and placebo. Comparisons between AMR101 and placebo were made using a significance level of 0.05.|Wilcoxon rank-sum test|A prespecified step-down testing procedure was used to control Type I error rate using 4 g/day vs placebo then, if significant, 2 g/day vs placebo.|Median differences between the treatment groups and 95% CIs were estimated with the Hodges-Lehmann method.|||-9.9|-17.2|0.0001
72614889|NCT01047501|144759878|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-5.5||||0.014|TWO_SIDED|95.0|-9.4|-1.7|||Wilcoxon rank-sum test||Median differences between the treatment groups and 95% CIs were estimated with the Hodges-Lehmann method.|||-1.7|-9.4|0.0140
72614890|NCT01047501|144759879|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-24.4||||0.0001|TWO_SIDED|95.0|-31.9|-17.0||Nonparametric analysis p values were planned using Wilcoxon rank-sum test for each comparison between AMR101 and placebo. Comparisons between AMR101 and placebo were made using a significance level of 0.05.|Wilcoxon rank-sum test|A prespecified step-down testing procedure was used to control Type I error rate using 4 g/day vs placebo then, if significant, 2 g/day vs placebo.|Median differences between the treatment groups and 95% CIs were estimated with the Hodges-Lehmann method.|||-17.0|-31.9|0.0001
72614891|NCT01047501|144759879|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-10.5||||0.017|TWO_SIDED|95.0|-18.3|-2.5|||Wilcoxon rank-sum test||Median differences between the treatment groups and 95% CIs were estimated with the Hodges-Lehmann method.|||-2.5|-18.3|0.0170
72614892|NCT01047501|144759880|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-19.0||||0.0001|TWO_SIDED|95.0|-22.2|-15.7||Nonparametric analysis p values were planned using Wilcoxon rank-sum test for each comparison between AMR101 and placebo. Comparisons between AMR101 and placebo were made using a significance level of 0.05.|Wilcoxon rank-sum test|A prespecified step-down testing procedure was used to control Type I error rate using 4 g/day vs placebo then, if significant, 2 g/day vs placebo.|Median differences between the treatment groups and 95% CIs were estimated with the Hodges-Lehmann method.|||-15.7|-22.2|0.0001
72614893|NCT01047501|144759880|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-8.0||||0.0004|TWO_SIDED|95.0|-11.6|-4.5|||Wilcoxon rank-sum test||Median differences between the treatment groups and 95% CIs were estimated with the Hodges-Lehmann method.|||-4.5|-11.6|0.0004
72622164|NCT04003142|144774326|SUPERIORITY||Odds Ratio (OR)|1.701||||0.225||95.0|0.733|4.169||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 12||4.169|0.733|0.225
72622165|NCT04003142|144774326|SUPERIORITY||Odds Ratio (OR)|3.049||||0.006||95.0|1.42|7.125||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 12||7.125|1.420|0.006
72554810|NCT00796653|144641384|SUPERIORITY_OR_OTHER||Incidence rate ratio|0.744|STANDARD_ERROR_OF_MEAN|0.1389||0.1136||95.0|0.5158|1.0733|||Negative binomial regression|Regression of treatment effect using tiotropium strata as a covariate, a log link function and log(exposure) as offset.|Olo 5 mcg qd minus Placebo|||1.0733|0.5158|0.1136
72554811|NCT00796653|144641384|SUPERIORITY_OR_OTHER||Incidence rate ratio|0.7842|STANDARD_ERROR_OF_MEAN|0.1449||0.1887||95.0|0.5456|1.1271|||Negative binomial regression|Regression of treatment effect using tiotropium strata as a covariate, a log link function and log(exposure) as offset.|Olo 10 mcg qd minus Placebo|||1.1271|0.5456|0.1887
72554812|NCT00796653|144641384|SUPERIORITY_OR_OTHER||Incidence rate ratio|0.9761|STANDARD_ERROR_OF_MEAN|0.1747||0.8925||95.0|0.6869|1.387|||Negative binomial regression|Regression of treatment effect using tiotropium strata as a covariate, a log link function and log(exposure) as offset.|Form 12 mcg minus Placebo|||1.3870|0.6869|0.8925
72554813|NCT00796653|144641387|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.509|STANDARD_ERROR_OF_MEAN|0.23||0.027|TWO_SIDED|95.0|0.058|0.96|||pattern mixture model|See Hogan, et. al. Hogan JW, Roy J, Korkontzelou C Tutorial in biostatistics:handling drop-out in longitudinal studies. Stat Med 23,1455-1497(2004)|"Based on a pattern mixture model with four patterns based on time of dropout (i.e., day of last observed data)~1\) day 43 or day 85, 2) day 127 or day 169, 3) day 225 or day 281, 4) day 337"|Olo 5mcg minus placebo||0.960|0.058|0.0270
72554814|NCT00796653|144641387|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.525|STANDARD_ERROR_OF_MEAN|0.226||0.0203|TWO_SIDED|95.0|0.082|0.967|||pattern mixture model|See Hogan, et. al. Hogan JW, Roy J, Korkontzelou C Tutorial in biostatistics:handling drop-out in longitudinal studies. Stat Med 23,1455-1497(2004)|"Based on a pattern mixture model with four patterns based on time of dropout (i.e., day of last observed data)~1\) day 43 or day 85, 2) day 127 or day 169, 3) day 225 or day 281, 4) day 337"|Olo 10 mcg minus placebo||0.967|0.082|0.0203
72554815|NCT00796653|144641387|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.355|STANDARD_ERROR_OF_MEAN|0.226||0.1166|TWO_SIDED|95.0|-0.088|0.799|||pattern mixture model|See Hogan, et. al. Hogan JW, Roy J, Korkontzelou C Tutorial in biostatistics:handling drop-out in longitudinal studies. Stat Med 23,1455-1497(2004)|"Based on a pattern mixture model with four patterns based on time of dropout (i.e., day of last observed data)~1\) day 43 or day 85, 2) day 127 or day 169, 3) day 225 or day 281, 4) day 337"|Form 12mcg minus placebo||0.799|-0.088|0.1166
72554816|NCT03393208|144641388|EQUIVALENCE|Analysis was performed with Equivalence Acceptance Range for 90% Confidence Interval (CI) as 80.00% - 125.00%|Ratio of Geometric LeastSquare(LS) Mean%|99.76|||||TWO_SIDED|90.0|92.84|107.2||||||Statistical Comparison of Treatment A Versus Treatment B in Fasting state||107.20|92.84|
72554817|NCT03393208|144641388|EQUIVALENCE|Analysis was performed with Equivalence Acceptance Range for 90% Confidence Interval (CI) as 80.00% - 125.00%|Ratio of Geometric LS Mean Percentage|98.67||||||90.0|91.25|106.69||||||Statistical Comparison of Treatment A Versus Treatment B in Fed state||106.69|91.25|
72565304|NCT03923699|144662078|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.29|TWO_SIDED|95.0|0.0|0.0||Not adjusted for multiple comparisons.|Regression, Linear|||||0.00|-0.00|0.29
72504975|NCT01462292|144541158|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.037||||0.89|TWO_SIDED|95.0|-0.498|0.571||No adjustment for multiplicity was made, so p-values should not be used to make conclusions with regards to statistical significance|ANCOVA|Model included terms for treatment, center grouping and baseline||Treatment difference: Placebo Vs GSK2402968 6 mg||0.571|-0.498|0.890
72565305|NCT03923699|144662079|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.37|TWO_SIDED|95.0|-0.01|0.0||Not adjusted for multiple comparisons.|Regression, Linear|||||0.00|-0.01|0.37
72565306|NCT03923699|144662080|SUPERIORITY||Risk Ratio (RR)|1.03||||0.3|TWO_SIDED|95.0|0.95|1.13||Not adjusted for multiple comparisons.|Regression, Poisson|||||1.13|0.95|0.30
72565307|NCT03923699|144662081|SUPERIORITY||Risk Ratio (RR)|1.0||||0.85|TWO_SIDED|95.0|0.98|1.02||Not adjusted for multiple comparisons.|Regression, Poisson|||||1.02|0.98|0.85
72565308|NCT03923699|144662082|SUPERIORITY||Risk Ratio (RR)|0.99||||0.51|TWO_SIDED|95.0|0.97|1.02||Not adjusted for multiple comparisons.|Regression, poisson|||||1.02|0.97|0.51
72565309|NCT01746264|144662083|SUPERIORITY_OR_OTHER|||||||0.59|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||P-value for change from baseline to 3 month follow-up.||||0.59
72565310|NCT01746264|144662084|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 3 month follow up visit.||||<0.001
72565311|NCT01746264|144662085|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 3 month follow-up.||||<0.01
72565312|NCT01746264|144662087|SUPERIORITY_OR_OTHER|||||||0.32|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 3 month follow-up.||||0.32
72565313|NCT01746264|144662088|SUPERIORITY_OR_OTHER|||||||0.21|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 3-month follow-up.||||0.21
72565314|NCT01746264|144662089|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 3 month follow-up.||||0.02
72565315|NCT01746264|144662090|SUPERIORITY_OR_OTHER|||||||0.0123|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 3 month follow-up.||||0.0123
72565316|NCT01746264|144662091|SUPERIORITY_OR_OTHER|||||||0.09|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 3 month follow-up.||||0.09
72565317|NCT01746264|144662092|SUPERIORITY_OR_OTHER|||||||0.27|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 3 month follow-up.||||0.27
72565318|NCT01746264|144662093|SUPERIORITY_OR_OTHER|||||||0.18|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 3 month follow-up.||||0.18
72565319|NCT01746264|144662094|SUPERIORITY_OR_OTHER|||||||0.33|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 3 month follow-up.||||0.33
72565320|NCT01746264|144662095|SUPERIORITY_OR_OTHER|||||||0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 3 month follow-up.||||0.05
72565321|NCT01746264|144662096|SUPERIORITY_OR_OTHER|||||||0.41|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 3 month follow-up.||||0.41
72565322|NCT01746264|144662097|SUPERIORITY_OR_OTHER|||||||0.32|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 3 month follow-up.||||0.32
72565323|NCT01746264|144662098|SUPERIORITY_OR_OTHER|||||||0.47|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 3 month follow-up.||||0.47
72614894|NCT01047501|144759881|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-9.3||||0.0001|TWO_SIDED|95.0|-12.3|-6.1||Nonparametric analysis p values were planned using Wilcoxon rank-sum test for each comparison between AMR101 and placebo. Comparisons between AMR101 and placebo were made using a significance level of 0.05.|Wilcoxon rank-sum test|A prespecified step-down testing procedure was used to control Type I error rate using 4 g/day vs placebo then, if significant, 2 g/day vs placebo.|Median differences between the treatment groups and 95% CIs were estimated with the Hodges-Lehmann method.|||-6.1|-12.3|0.0001
72614895|NCT01047501|144759881|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-3.8||||0.017|TWO_SIDED|95.0|-6.9|-0.7|||Wilcoxon rank-sum test||Median differences between the treatment groups and 95% CIs were estimated with the Hodges-Lehmann method.|||-0.7|-6.9|0.0170
72614896|NCT04502524|144759933|OTHER|||||||0.999|||||||Fisher Exact|||For overall satisfaction, a reliable estimate could not be calculated using a logistic regression model as all the responses were the same in the Vet Flexiquit arm. We calculated the p-value using the Fisher's exact test.||||.999
72614897|NCT04502524|144759934|OTHER||Slope|0.05||||0.852|TWO_SIDED|95.0|-0.46|0.56|||Regression, negative binomial|||||0.56|-0.46|0.852
72614898|NCT04502524|144759935|OTHER||Slope|-0.44||||0.451|TWO_SIDED|95.0|-1.6|0.71|||Regression, negative binomial|||||0.71|-1.60|0.451
72614899|NCT04502524|144759936|OTHER||Slope|-0.73||||0.508|TWO_SIDED|95.0|-1.46|0.003|||Regression, negative binomial|||||0.003|-1.46|0.508
72614900|NCT04502524|144759937|OTHER||Odds Ratio (OR)|0.65||||0.602|TWO_SIDED|95.0|0.13|3.32|||Regression, Logistic|||||3.32|0.13|0.602
72614901|NCT04502524|144759938|OTHER||Odds Ratio (OR)|0.94||||0.941|TWO_SIDED|95.0|0.17|5.29|||Regression, Logistic|||||5.29|0.17|0.941
72614902|NCT04502524|144759939|OTHER||Odds Ratio (OR)|0.61||||0.612|TWO_SIDED|95.0|0.09|4.12|||Regression, Logistic|||||4.12|0.09|0.612
72614903|NCT04502524|144759940|OTHER||Slope|0.56||||0.504|TWO_SIDED|95.0|-1.13|2.26|||Regression, Linear|||||2.26|-1.13|0.504
72614904|NCT04502524|144759941|OTHER||Slope|0.11||||0.67|TWO_SIDED|95.0|-0.4|0.61|||Regression, Linear|||||0.61|-0.40|0.670
72614905|NCT01018979|144759952|SUPERIORITY_OR_OTHER_LEGACY|||||||0.023|TWO_SIDED|||||P values less than 0.05 are considered statistically significant in this study.|t-test, 2 sided|||Analyze whether the mean fold increase from the baseline to the peak time change was significant or not.||||0.023
72614906|NCT01018979|144759952|SUPERIORITY_OR_OTHER_LEGACY|||||||0.038|TWO_SIDED|||||P values less than 0.05 are considered statistically significant in this study.|t-test, 2 sided|||Analyze whether the mean fold increase from the baseline to the peak time change was significant or not.||||0.038
72614907|NCT03010501|144759963|SUPERIORITY||||||<|0.0001||||||According to predefined comparisons, outcomes of the 80% and 120% Food Energy Density interventions were compared to the outcome of the baseline (100%) intervention.|Mixed Models Analysis|||||||< 0.0001
72614908|NCT03010501|144759964|SUPERIORITY|||||||0.1||||||According to predefined comparisons, intake by weight in the 80% intervention was compared to the 100% intervention.|Mixed Models Analysis|||||||0.10
72614909|NCT03010501|144759964|SUPERIORITY|||||||0.15||||||According to predefined comparisons, intake by weight in the 120% intervention was compared to the 100% intervention.|Mixed Models Analysis|||||||0.15
72614910|NCT03010501|144759965|SUPERIORITY||||||<|0.0001||||||According to predefined comparisons, outcomes of the 80% and 120% Food Energy Density interventions were compared to the outcome of the baseline (100%) intervention.|Mixed Models Analysis|||||||< 0.0001
72614911|NCT00544882|144760000|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6346|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at Cycle 2 - Day 2 time point. p-values \< 0.05 were considered statistically significant.||||0.6346
72614912|NCT00544882|144760000|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2757|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at Cycle 2 - Day 4 time point.||||0.2757
72614913|NCT00544882|144760000|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1321|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at Cycle 2 - Day 6 time point.||||0.1321
72614914|NCT00544882|144760000|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5543|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at Cycle 2 - Days 19-20 time point.||||0.5543
72614915|NCT00544882|144760000|SUPERIORITY_OR_OTHER_LEGACY|||||||0.394|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at Cycle 2 - Day 23 time point.||||0.3940
72614916|NCT00544882|144760000|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7891|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at Cycle 2 - Day 24 time point.||||0.7891
72614917|NCT00544882|144760000|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4829|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at Cycle 2 - Day 25 time point.||||0.4829
72614918|NCT00544882|144760000|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4526|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at Cycle 2 - Day 27 time point.||||0.4526
72614919|NCT00544882|144760000|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2485|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at Cycle 2 - Day 28 time point.||||0.2485
72614920|NCT00544882|144760000|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6252|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at Cycle 3 - Day 2 time point.||||0.6252
72614921|NCT00544882|144760000|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4003|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at Cycle 3 - Day 4 time point.||||0.4003
72614922|NCT00544882|144760000|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8841|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at Cycle 3 - Day 6 time point.||||0.8841
72614923|NCT00544882|144760002|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8892|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at Cycle 2 - Day 2 time point. p-values \< 0.05 were considered statistically significant.||||0.8892
72614924|NCT00544882|144760002|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7678|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at Cycle 2 - Day 4 time point.||||0.7678
72614925|NCT00544882|144760002|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5782|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at Cycle 2 - Day 6 time point.||||0.5782
72614926|NCT00544882|144760002|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8083|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at Cycle 2 - Days 19-20 time point.||||0.8083
72614927|NCT00544882|144760002|SUPERIORITY_OR_OTHER_LEGACY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at Cycle 2 - Day 23 time point.||||1.0000
72614928|NCT00544882|144760002|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4122|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at Cycle 2 - Day 24 time point.||||0.4122
72614929|NCT00544882|144760002|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6675|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at Cycle 2 - Day 25 time point.||||0.6675
72614930|NCT00544882|144760002|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8445|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at Cycle 2 - Day 27 time point.||||0.8445
72614931|NCT00544882|144760002|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3772|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at Cycle 2 - Day 28 time point.||||0.3772
72614932|NCT00544882|144760002|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1918|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at Cycle 3 - Day 2 time point.||||0.1918
72614933|NCT00544882|144760002|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6675|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at Cycle 3 - Day 4 time point.||||0.6675
72614934|NCT00544882|144760002|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9226|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at Cycle 3 - Day 6 time point.||||0.9226
72614935|NCT00544882|144760003|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0979|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at Cycle 2 - Day 2 time point. p-values \< 0.05 were considered statistically significant.||||0.0979
72614936|NCT00544882|144760003|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0629|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at Cycle 2 - Day 4 time point.||||0.0629
72614937|NCT00544882|144760003|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8464|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at Cycle 2 - Day 6 time point.||||0.8464
72614938|NCT00544882|144760003|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6316|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at Cycle 2 - Days 19-20 time point.||||0.6316
72614939|NCT00544882|144760003|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at Cycle 2 - Day 23 time point.||||0.3000
72614940|NCT00544882|144760003|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0955|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at Cycle 2 - Day 24 time point.||||0.0955
72614941|NCT00544882|144760003|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1523|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at Cycle 3 - Day 25 time point.||||0.1523
72614942|NCT00544882|144760003|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2809|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at Cycle 2 - Day 27 time point.||||0.2809
72614943|NCT00544882|144760003|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8829|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at Cycle 3 - Day 28 time point.||||0.8829
72614944|NCT00544882|144760003|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9262|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at Cycle 3 - Day 2 time point.||||0.9262
72614945|NCT00544882|144760003|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7811|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at Cycle 3 -Day 4 time point.||||0.7811
72614946|NCT00544882|144760003|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3703|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at Cycle 3 - Day 6 time point.||||0.3703
72614947|NCT03043573|144760009|SUPERIORITY||Mean Difference (Final Values)|-0.7011||||0.9644|TWO_SIDED|95.0|-31.8605|30.4583|||t-test, 2 sided|||Baseline||30.4583|-31.8605|0.9644
72614948|NCT03043573|144760009|SUPERIORITY||Mean Difference (Final Values)|2.4595||||0.888|TWO_SIDED|95.0|-32.3472|37.2661|||t-test, 2 sided|||Week 12||37.2661|-32.3472|0.8880
72614949|NCT03043573|144760009|SUPERIORITY||Mean Difference (Final Values)|-0.5119||||0.9773|TWO_SIDED|95.0|-36.5024|35.4785|||t-test, 2 sided|||Week 24||35.4785|-36.5024|0.9773
72614950|NCT03043573|144760009|SUPERIORITY||Mean Difference (Final Values)|15.6667||||0.6173|TWO_SIDED|95.0|-47.0598|78.3931|||t-test, 1 sided|||Week 52||78.3931|-47.0598|0.6173
72614951|NCT03043573|144760010|SUPERIORITY||Mean Difference (Final Values)|1.1302||||0.5454|TWO_SIDED|95.0|-2.5767|4.8371|||t-test, 2 sided|||Baseline||4.8371|-2.5767|0.5454
72614952|NCT03043573|144760010|SUPERIORITY||Mean Difference (Final Values)|2.9618||||0.1212|TWO_SIDED|95.0|-0.8038|6.7275|||t-test, 2 sided|||Week 6||6.7275|-0.8038|0.1212
72614953|NCT03043573|144760010|SUPERIORITY||Mean Difference (Final Values)|1.095||||0.571|TWO_SIDED|95.0|-2.7476|4.9377|||t-test, 2 sided|||Week 12||4.9377|-2.7476|0.5710
72614954|NCT03043573|144760010|SUPERIORITY||Mean Difference (Final Values)|-1.5524||||0.4377|TWO_SIDED|95.0|-5.5256|2.4209|||t-test, 2 sided|||Week 24||2.4209|-5.5256|0.4377
72614955|NCT03043573|144760010|SUPERIORITY||Mean Difference (Final Values)|0.8937||||0.6813|TWO_SIDED|95.0|-3.4439|5.2312|||t-test, 2 sided|||Week 36||5.2312|-3.4439|0.6813
72614956|NCT03043573|144760010|SUPERIORITY||Mean Difference (Final Values)|2.9457||||0.162|TWO_SIDED|95.0|-1.2234|7.1148|||t-test, 2 sided|||||7.1148|-1.2234|0.1620
72614957|NCT03043573|144760011|SUPERIORITY||Mean Difference (Final Values)|0.0319||||0.9813|TWO_SIDED|95.0|-2.6668|2.7305|||t-test, 2 sided|||Baseline||2.7305|-2.6668|0.9813
72614958|NCT03043573|144760011|SUPERIORITY||Mean Difference (Final Values)|-0.0564||||0.9735|TWO_SIDED|95.0|-3.4397|3.3268|||t-test, 2 sided|||Week 6||3.3268|-3.4397|0.9735
72614959|NCT03043573|144760011|SUPERIORITY|Week 12|Mean Difference (Final Values)|1.0611||||0.5164|TWO_SIDED|95.0|-2.1885|4.3107|||t-test, 2 sided|||||4.3107|-2.1885|0.5164
72614960|NCT03043573|144760011|SUPERIORITY||Mean Difference (Final Values)|-2.0||||0.197|TWO_SIDED|95.0|-5.0651|1.0651|||t-test, 2 sided|||Week 24||1.0651|-5.0651|0.1970
72614961|NCT03043573|144760011|SUPERIORITY||Mean Difference (Net)|0.362||||0.8342|TWO_SIDED|95.0|-3.0907|3.8146|||t-test, 2 sided|||Week 36||3.8146|-3.0907|0.8342
72614962|NCT03043573|144760011|SUPERIORITY||Mean Difference (Final Values)|1.2667||||0.4717|TWO_SIDED|95.0|-2.2424|4.7758|||t-test, 2 sided|||Week 52||4.7758|-2.2424|0.4717
72614963|NCT03043573|144760012|SUPERIORITY||Mean Difference (Final Values)|-2.9318||||0.513|TWO_SIDED|95.0|-11.8176|5.9539|||t-test, 2 sided|||Baseline||5.9539|-11.8176|0.5130
72614964|NCT03043573|144760012|SUPERIORITY||Mean Difference (Final Values)|0.4835||||0.4835|TWO_SIDED|95.0|-15.2306|7.2967|||t-test, 2 sided|||Week 12||7.2967|-15.2306|0.4835
72614965|NCT03043573|144760012|SUPERIORITY||Mean Difference (Final Values)|-5.156||||0.359|TWO_SIDED|95.0|-16.3357|6.0238|||t-test, 2 sided|||Week 24||6.0238|-16.3357|0.3590
72614966|NCT03043573|144760012|SUPERIORITY||Mean Difference (Final Values)|1.1083||||0.876|TWO_SIDED|95.0|-13.1598|15.3765|||t-test, 2 sided|||Week 52||15.3765|-13.1598|0.8760
72614967|NCT03043573|144760013|SUPERIORITY||Mean Difference (Final Values)|-0.0606||||0.3248|TWO_SIDED|95.0|-0.1841|0.0628|||t-test, 2 sided|||Trails A Baseline||0.0628|-0.1841|0.3248
72614968|NCT03043573|144760013|SUPERIORITY||Mean Difference (Final Values)|-0.6953||||0.3615|TWO_SIDED|95.0|-2.2261|0.8354|||t-test, 2 sided|||Trails A - Week 12||0.8354|-2.2261|0.3615
72614969|NCT03043573|144760013|SUPERIORITY||Mean Difference (Final Values)|0.9917||||0.5046|TWO_SIDED|95.0|-1.9664|3.9498|||t-test, 2 sided|||Trails B - Baseline||3.9498|-1.9664|0.5046
72614970|NCT03043573|144760013|SUPERIORITY||Mean Difference (Final Values)|-2.0607||||0.0679|TWO_SIDED|95.0|-4.2821|0.1607|||t-test, 2 sided|||Trails B - Week 12||0.1607|-4.2821|0.0679
72614971|NCT03043573|144760013|SUPERIORITY||Mean Difference (Final Values)|-0.8929||||0.1669|TWO_SIDED|95.0|-2.1825|0.3968|||t-test, 2 sided|||Trails B - Week 24||0.3968|-2.1825|0.1669
72614972|NCT03043573|144760013|SUPERIORITY||Mean Difference (Final Values)|-1.4286||||0.2178|TWO_SIDED|95.0|-3.8115|0.9543|||t-test, 2 sided|||Trails B - Week 52||0.9543|-3.8115|0.2178
72614973|NCT03043573|144760014|SUPERIORITY||Mean Difference (Final Values)|1.558||||0.2932|TWO_SIDED|95.0|-1.3747|4.4908|||t-test, 2 sided|||Baseline||4.4908|-1.3747|0.2932
72614974|NCT03043573|144760014|SUPERIORITY||Mean Difference (Final Values)|1.7043||||0.2871|TWO_SIDED|95.0|-1.4659|4.8744|||t-test, 2 sided|||Week 6||4.8744|-1.4659|0.2871
72614975|NCT03043573|144760014|SUPERIORITY||Mean Difference (Final Values)|0.9167||||0.591|TWO_SIDED|95.0|-2.4737|4.307|||t-test, 2 sided|||Week 12||4.3070|-2.4737|0.5910
72614976|NCT03043573|144760014|SUPERIORITY||Mean Difference (Final Values)|-1.0238||||0.6128|TWO_SIDED|95.0|-5.0469|2.9993|||t-test, 2 sided|||||2.9993|-5.0469|0.6128
72614977|NCT03043573|144760014|SUPERIORITY||Mean Difference (Final Values)|1.9276||||0.3326|TWO_SIDED|95.0|-2.0231|5.8783|||t-test, 2 sided|||Week 36||5.8783|-2.0231|0.3326
72614978|NCT03043573|144760014|SUPERIORITY||Mean Difference (Final Values)|2.0741||||0.2935|TWO_SIDED|95.0|-1.8522|6.0004|||t-test, 2 sided|||Week 52||6.0004|-1.8522|0.2935
72614979|NCT02906618|144760049|OTHER|A mixed-effect analysis of variance model was applied to the log-transformed dose-adjusted AUC(0-∞) of LY3039478 after oral dosing and IV administration of 13C 15N 2H-LY3039478. The model contained a fixed effect for formulation (oral or IV) and a random effect for participant.|Ratio of geometric LS means|0.572|||||TWO_SIDED|90.0|0.532|0.615||||||||0.615|0.532|
72614980|NCT00143507|144760053|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.0||||0.945|TWO_SIDED|95.0|0.91|1.1|||Regression, Cox||Estimate of the hazard ratio between treatment groups based on an adjusted Cox proportional hazards model with beta-blocker intake as a covariate. P-value: Log-rank test stratified on beta-blocker intake factor.|||1.10|0.91|0.945
72614981|NCT00143507|144760054|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.07||||0.316|TWO_SIDED|95.0|0.94|1.22|||Regression, Cox||Estimate of the hazard ratio between treatment groups based on an adjusted Cox proportional hazards model with beta-blocker intake as a covariate. P-value: Log-rank test stratified on beta-blocker intake factor.|||1.22|0.94|0.316
72614982|NCT00143507|144760055|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.87||||0.159|TWO_SIDED|95.0|0.72|1.06|||Regression, Cox||Estimate of the hazard ratio between treatment groups based on an adjusted Cox proportional hazards model with beta-blocker intake as a covariate. P-value: Log-rank test stratified on beta-blocker intake factor.|||1.06|0.72|0.159
72614983|NCT00143507|144760056|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.99||||0.85|TWO_SIDED|95.0|0.86|1.13|||Regression, Cox||Estimate of the hazard ratio between treatment groups based on an adjusted Cox proportional hazards model with beta-blocker intake as a covariate. P-value: Log-rank test stratified on beta-blocker intake factor.|||1.13|0.86|0.850
72614984|NCT00143507|144760057|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.04||||0.547|TWO_SIDED|95.0|0.92|1.16|||Regression, Cox||Estimate of the hazard ratio between treatment groups based on an adjusted Cox proportional hazards model with beta-blocker intake as a covariate. P-value: Log-rank test stratified on beta-blocker intake factor.|||1.16|0.92|0.547
72614985|NCT00143507|144760058|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.89||||0.331|TWO_SIDED|95.0|0.71|1.12|||Regression, Cox||Estimate of the hazard ratio between treatment groups based on an adjusted Cox proportional hazards model with beta-blocker intake as a covariate. P-value: Log-rank test stratified on beta-blocker intake factor.|||1.12|0.71|0.331
72614986|NCT00143507|144760059|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.83||||0.078|TWO_SIDED|95.0|0.67|1.02|||Regression, Cox||Estimate of the hazard ratio between treatment groups based on an adjusted Cox proportional hazards model with beta-blocker intake as a covariate. P-value: Log-rank test stratified on beta-blocker intake factor.|||1.02|0.67|0.078
72614987|NCT00143507|144760060|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.08||||0.583|TWO_SIDED|95.0|0.83|1.4|||Regression, Cox||Estimate of the hazard ratio between treatment groups based on an adjusted Cox proportional hazards model with beta-blocker intake as a covariate. P-value: Log-rank test stratified on beta-blocker intake factor.|||1.40|0.83|0.583
72614988|NCT00143507|144760061|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.95||||0.501|TWO_SIDED|95.0|0.81|1.11|||Regression, Cox||Estimate of the hazard ratio between treatment groups based on an adjusted Cox proportional hazards model with beta-blocker intake as a covariate. P-value: Log-rank test stratified on beta-blocker intake factor.|||1.11|0.81|0.501
72614989|NCT00143507|144760062|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.9||||0.141|TWO_SIDED|95.0|0.78|1.04|||Regression, Cox||Estimate of the hazard ratio between treatment groups based on an adjusted Cox proportional hazards model with beta-blocker intake as a covariate. P-value: Log-rank test stratified on beta-blocker intake factor.|||1.04|0.78|0.141
72614990|NCT00143507|144760063|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.96||||0.411|TWO_SIDED|95.0|0.86|1.06|||Regression, Cox||Estimate of the hazard ratio between treatment groups based on an adjusted Cox proportional hazards model with beta-blocker intake as a covariate. P-value: Log-rank test stratified on beta-blocker intake factor.|||1.06|0.86|0.411
72614991|NCT00143507|144760064|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.04||||0.484|TWO_SIDED|95.0|0.94|1.15|||Regression, Cox||Estimate of the hazard ratio between treatment groups based on an adjusted Cox proportional hazards model with beta-blocker intake as a covariate. P-value: Log-rank test stratified on beta-blocker intake factor.|||1.15|0.94|0.484
72614992|NCT00143507|144760065|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.01||||0.835|TWO_SIDED|95.0|0.9|1.13|||Regression, Cox||Estimate of the hazard ratio between treatment groups based on an adjusted Cox proportional hazards model with beta-blocker intake as a covariate. P-value: Log-rank test stratified on beta-blocker intake factor.|||1.13|0.90|0.835
72614993|NCT01991314|144760096|NON_INFERIORITY_OR_EQUIVALENCE|We calculated, on the premise that there is non-inferiority between adolescent and adult groups in the difference in increase of mean haemoglobin levels of 0.35g/dL, with estimated standard deviation 0.7g/dL following treatment, that 45 patients in each group would be required, derived using power 80% power, 1-sided significance level 0.05 and R 0.5 for the covariate; this calculation took into account planned ANCOVA methodology and 20% patients who might be lost to follow up or withdraw.|Mean Difference (Net)|0.08||||0.23|TWO_SIDED|||||To test the hypothesis of non-inferiority with maximal statistical power, ANCOVA (one-tailed P\<0.05) was employed to compare the change in mean haemoglobin levels between adults and adolescents after accounting for necessary covariates|ANCOVA|||||||0.23
72622166|NCT03382873|144774348|SUPERIORITY||||||<|0.0001|||||||ANOVA|||||||<0.0001
72614994|NCT01991314|144760097|SUPERIORITY_OR_OTHER||difference in proportions|3.6|||<|0.05|TWO_SIDED||||||Fisher Exact|Fisher's exact test was used to compare proportions (expressed as percentages) of total number of participants in each group who were iron intolerant||Chi squared test or Fisher's exact test, as appropriate.||||<0.05
72614995|NCT01991314|144760098|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.0||||0.96|TWO_SIDED||||||t-test, 2 sided|||Unpaired Students t test||||0.96
72614996|NCT01991314|144760099|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.5||||0.49|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Mann-Whitney U test||||0.49
72614997|NCT01991314|144760100|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.4||||0.85|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Mann Whitney U test||||0.85
72614998|NCT01991314|144760101|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.0||||0.69|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Mann Whitney U test||||0.69
72614999|NCT01991314|144760102|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-15.9|||<|0.0001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Mann-Whitney U test||||<0.0001
72615000|NCT00879359|144760103|SUPERIORITY_OR_OTHER||Hazard Ratio, log|92.0|||||TWO_SIDED|95.0|64.0|99.0||||||||99|64|
72615001|NCT00970944|144760106|SUPERIORITY_OR_OTHER|||||||0.045||95.0|||||Mixed Models Analysis|||We will have 80% power to detect a one point difference in DRS score between the groups across the four week treatment window. With this sample size, we will be able to detect any unforeseen adverse events that have a prevalence of at least 2.5% in each group with 90% probability. With 92 patients per group we will be able to estimate the rate of adverse events to within ±10%.||||0.045
72615002|NCT00970944|144760107|SUPERIORITY_OR_OTHER||Slope|-0.24|STANDARD_ERROR_OF_MEAN|0.088||0.007||95.0|-0.41|-0.07||The final analysis used a significance level of 0.045.|Mixed Models Analysis|Final analysis adjusted for early v. late enrollment relative to date of injury, baseline CRS-R rating category (MCS vs. VS), and site.||The planned sample size of 184 patients provided 80% power to detect a difference between the AH and placebo in the rate of Disability Rating Scale (DRS) score change of 0.3 points/week (1.22 DRS point mean difference by the end of the 4-week treatment interval). Two blinded interim analyses were conducted at 60 and 120 patients recruited using the O'Brien-Fleming boundary, with alpha levels of 0.0005 and 0.014. The final analysis used an alpha level of 0.045.||-0.07|-0.41|0.007
72615003|NCT03915067|144760114|SUPERIORITY||Rate Difference|65.8|||<|0.0001|TWO_SIDED|95.0|51.5|80.1||P-value derived from CMH model stratified by investigator site and C-APPS at Day 1.|Cochran-Mantel-Haenszel|||||80.1|51.5|<0.0001
72615004|NCT03915067|144760114|SUPERIORITY||Rate Difference|76.2|||<|0.0001|TWO_SIDED|95.0|63.6|88.9||P-value derived from CMH model stratified by investigator site and C-APPS at Day 1.|Cochran-Mantel-Haenszel|||||88.9|63.6|<0.0001
72615005|NCT03915067|144760137|SUPERIORITY||Rate Difference|57.9|||<|0.0001|TWO_SIDED|95.0|42.3|73.5||P-value was derived from CMH model stratified by investigator site and P-APPS at Day 1.|Cochran-Mantel-Haenszel|||||73.5|42.3|<0.0001
72615006|NCT03915067|144760137|SUPERIORITY||Rate Difference|70.2|||<|0.0001|TWO_SIDED|95.0|56.4|84.1||P-value derived from CMH model stratified by investigator site and P-APPS at Day 1.|Cochran-Mantel-Haenszel|||||84.1|56.4|<0.0001
72615007|NCT01033942|144760138|SUPERIORITY_OR_OTHER|||||||0.6983||||||The p-value is for the difference in treatment (TX) groups overall. The interaction between TX group and study time that tests whether the TX groups differed over time could not be tested due to small no. of subjects that missed visits during study.|Chi-squared|||||||0.6983
72615008|NCT01033942|144760139|SUPERIORITY_OR_OTHER|||||||0.8722|TWO_SIDED||||||Fisher Exact|||||||0.8722
72615009|NCT01033942|144760140|SUPERIORITY_OR_OTHER|||||||0.6921||||||Not all subjects answered every question.|Fisher Exact|||||||0.6921
72615010|NCT01033942|144760141|SUPERIORITY_OR_OTHER|||||||0.4655||||||Not all participants answered every question|Fisher Exact|||||||0.4655
72615011|NCT01033942|144760142|SUPERIORITY_OR_OTHER|||||||0.9999|TWO_SIDED|||||Not all participants answered every question|Fisher Exact|||||||0.9999
72615012|NCT01033942|144760143|SUPERIORITY_OR_OTHER|||||||0.2297|TWO_SIDED|||||Not all participants answered every question|Fisher Exact|||||||0.2297
72615013|NCT01033942|144760144|SUPERIORITY_OR_OTHER|||||||0.1886||||||Not all participants answered every question|Fisher Exact|||||||0.1886
72615014|NCT01033942|144760145|SUPERIORITY_OR_OTHER|||||||0.1908|||||||Fisher Exact|||||||0.1908
72615015|NCT01033942|144760146|SUPERIORITY_OR_OTHER|||||||0.224||||||Not all participants answered every question|Fisher Exact|||||||0.2240
72615016|NCT01033942|144760147|SUPERIORITY_OR_OTHER|||||||0.1538||||||Not all participants answered every question|Fisher Exact|||||||0.1538
72615017|NCT01033942|144760148|SUPERIORITY_OR_OTHER|||||||0.2151||||||Not all participants answered every question|Fisher Exact|||||||0.2151
72615018|NCT01033942|144760149|SUPERIORITY_OR_OTHER|||||||0.2809||||||Not all participants answered every question|Fisher Exact|||||||0.2809
72615019|NCT01033942|144760150|SUPERIORITY_OR_OTHER|||||||0.185||||||Not all participants answered every question|Fisher Exact|||||||0.1850
72615020|NCT01033942|144760151|SUPERIORITY_OR_OTHER|||||||0.2366||||||Not all participants answered every question|Fisher Exact|||||||0.2366
72615021|NCT01033942|144760152|SUPERIORITY_OR_OTHER|||||||0.4089||||||Not all subjects answered every question.|Fisher Exact|||||||0.4089
72615022|NCT01033942|144760153|SUPERIORITY_OR_OTHER|||||||0.9999|TWO_SIDED||||||Fisher Exact|||||||0.9999
72615023|NCT01033942|144760154|SUPERIORITY_OR_OTHER|||||||0.9999|TWO_SIDED||||||Fisher Exact|||||||0.9999
72615024|NCT01033942|144760155|SUPERIORITY_OR_OTHER|||||||0.9999|TWO_SIDED||||||Fisher Exact|||||||0.9999
72615025|NCT01033942|144760156|SUPERIORITY_OR_OTHER|||||||0.7007|||||||Fisher Exact|||||||0.7007
72615026|NCT01033942|144760157|SUPERIORITY_OR_OTHER|||||||0.9999|TWO_SIDED||||||Fisher Exact|||||||0.9999
72615027|NCT01033942|144760158|SUPERIORITY_OR_OTHER|||||||0.9999|TWO_SIDED||||||Fisher Exact|||||||0.9999
72615028|NCT01033942|144760159|SUPERIORITY_OR_OTHER|||||||0.8934|||||||Chi-squared|||||||0.8934
72615029|NCT01033942|144760160|SUPERIORITY_OR_OTHER|||||||0.9999|TWO_SIDED||||||Fisher Exact|||||||0.9999
72615030|NCT01033942|144760161|SUPERIORITY_OR_OTHER|||||||0.9999|TWO_SIDED||||||Fisher Exact|||||||0.9999
72615031|NCT01033942|144760162|SUPERIORITY_OR_OTHER|||||||0.9999|TWO_SIDED||||||Fisher Exact|||||||0.9999
72615032|NCT01033942|144760163|SUPERIORITY_OR_OTHER|||||||0.4003|||||||Fisher Exact|||||||0.4003
72615033|NCT01033942|144760164|SUPERIORITY_OR_OTHER|||||||0.6462|||||||Fisher Exact|||||||0.6462
72615034|NCT01033942|144760165|SUPERIORITY_OR_OTHER|||||||0.8505|||||||Chi-squared|||||||0.8505
72615035|NCT01033942|144760173|SUPERIORITY_OR_OTHER|||||||0.7434|TWO_SIDED||||||Chi-squared|||||||0.7434
72615036|NCT01033942|144760174|SUPERIORITY_OR_OTHER|||||||0.6153|TWO_SIDED||||||Chi-squared|||||||0.6153
72615037|NCT01033942|144760175|SUPERIORITY_OR_OTHER|||||||0.2|TWO_SIDED||||||Chi-squared|||||||0.2000
72615038|NCT01033942|144760176|SUPERIORITY_OR_OTHER|||||||0.5265|TWO_SIDED||||||Chi-squared|||||||0.5265
72615039|NCT01033942|144760177|SUPERIORITY_OR_OTHER|||||||0.2559|TWO_SIDED||||||Chi-squared|||||||0.2559
72615040|NCT01033942|144760178|SUPERIORITY_OR_OTHER|||||||0.3846|TWO_SIDED||||||Chi-squared|||||||0.3846
72615041|NCT01033942|144760179|SUPERIORITY_OR_OTHER|||||||0.5133|TWO_SIDED||||||Chi-squared|||||||0.5133
72615042|NCT01033942|144760180|SUPERIORITY_OR_OTHER|||||||0.1661|TWO_SIDED||||||Chi-squared|||||||0.1661
72615043|NCT01033942|144760181|SUPERIORITY_OR_OTHER|||||||0.0729|TWO_SIDED||||||Chi-squared|||||||0.0729
72615044|NCT01033942|144760182|SUPERIORITY_OR_OTHER|||||||0.1912|TWO_SIDED||||||Chi-squared|||||||0.1912
72615045|NCT01033942|144760183|SUPERIORITY_OR_OTHER|||||||0.2829|TWO_SIDED||||||Chi-squared|||||||0.2829
72615046|NCT01033942|144760184|SUPERIORITY_OR_OTHER|||||||0.2685|TWO_SIDED||||||Chi-squared|||||||0.2685
72615047|NCT01033942|144760185|SUPERIORITY_OR_OTHER|||||||0.2342|TWO_SIDED||||||Chi-squared|||||||0.2342
72615048|NCT01033942|144760186|SUPERIORITY_OR_OTHER|||||||0.7314|TWO_SIDED||||||Fisher Exact|||||||0.7314
72615049|NCT01033942|144760187|SUPERIORITY_OR_OTHER|||||||0.377|||||||Fisher Exact|||||||0.3770
72615050|NCT01033942|144760188|SUPERIORITY_OR_OTHER|||||||0.7004|||||||Fisher Exact|||||||0.7004
72615051|NCT01033942|144760189|SUPERIORITY_OR_OTHER|||||||0.4668|||||||Fisher Exact|||||||0.4668
72615052|NCT01033942|144760190|SUPERIORITY_OR_OTHER|||||||0.7573|||||||Fisher Exact|||||||0.7573
72615053|NCT01033942|144760191|SUPERIORITY_OR_OTHER|||||||0.0356|||||||Fisher Exact|||||||0.0356
72615054|NCT01033942|144760192|SUPERIORITY_OR_OTHER|||||||0.3176|||||||Fisher Exact|||||||0.3176
72615055|NCT01033942|144760193|SUPERIORITY_OR_OTHER|||||||0.1348|||||||Fisher Exact|||||||0.1348
72615056|NCT01033942|144760194|SUPERIORITY_OR_OTHER|||||||0.042|||||||Fisher Exact|||||||0.0420
72615057|NCT01033942|144760195|SUPERIORITY_OR_OTHER|||||||0.4906|||||||Fisher Exact|||||||0.4906
72615058|NCT01033942|144760196|SUPERIORITY_OR_OTHER|||||||0.0544|||||||Fisher Exact|||||||0.0544
72615059|NCT01033942|144760197|SUPERIORITY_OR_OTHER|||||||0.5645|||||||Fisher Exact|||||||0.5645
72615060|NCT01033942|144760198|SUPERIORITY_OR_OTHER|||||||0.7847|||||||Fisher Exact|||||||0.7847
72615061|NCT01033942|144760199|SUPERIORITY_OR_OTHER|||||||0.0288|||||||Fisher Exact|||||||0.0288
72615062|NCT01033942|144760200|SUPERIORITY_OR_OTHER|||||||0.0945|||||||Fisher Exact|||||||0.0945
72615063|NCT01033942|144760201|SUPERIORITY_OR_OTHER|||||||0.3884|||||||Fisher Exact|||||||0.3884
72615064|NCT01033942|144760202|SUPERIORITY_OR_OTHER|||||||0.2235|||||||Fisher Exact|||||||0.2235
72615065|NCT01033942|144760203|SUPERIORITY_OR_OTHER|||||||0.0467|||||||Fisher Exact|||||||0.0467
72615066|NCT01033942|144760204|SUPERIORITY_OR_OTHER|||||||0.6331|||||||Fisher Exact|||||||0.6331
72615067|NCT01033942|144760205|SUPERIORITY_OR_OTHER|||||||0.0948|||||||Fisher Exact|||||||0.0948
72615068|NCT01033942|144760206|SUPERIORITY_OR_OTHER|||||||0.5826|||||||Fisher Exact|||||||0.5826
72615069|NCT01033942|144760207|SUPERIORITY_OR_OTHER|||||||0.0087|||||||Fisher Exact|||||||0.0087
72615070|NCT01033942|144760208|SUPERIORITY_OR_OTHER|||||||0.1934|||||||Fisher Exact|||||||0.1934
72615071|NCT01033942|144760209|SUPERIORITY_OR_OTHER|||||||0.2146|||||||Fisher Exact|||||||0.2146
72615072|NCT01033942|144760210|SUPERIORITY_OR_OTHER|||||||0.5317|||||||Fisher Exact|||||||0.5317
72615073|NCT01033942|144760211|SUPERIORITY_OR_OTHER|||||||0.1733|||||||Fisher Exact|||||||0.1733
72615074|NCT01033942|144760212|SUPERIORITY_OR_OTHER|||||||0.1747|||||||Fisher Exact|||||||0.1747
72615075|NCT01033942|144760213|SUPERIORITY_OR_OTHER|||||||0.1203|||||||Fisher Exact|||||||0.1203
72615076|NCT01033942|144760214|SUPERIORITY_OR_OTHER|||||||0.8243|||||||Fisher Exact|||||||0.8243
72615077|NCT01033942|144760215|SUPERIORITY_OR_OTHER|||||||0.6202|||||||Fisher Exact|||||||0.6202
72615078|NCT01033942|144760216|SUPERIORITY_OR_OTHER|||||||0.8351|||||||Fisher Exact|||||||0.8351
72615079|NCT01033942|144760217|SUPERIORITY_OR_OTHER|||||||0.0484|||||||Fisher Exact|||||||0.0484
72615080|NCT01033942|144760218|SUPERIORITY_OR_OTHER|||||||0.4207|||||||Fisher Exact|||||||0.4207
72615081|NCT01033942|144760219|SUPERIORITY_OR_OTHER|||||||0.2187|||||||Fisher Exact|||||||0.2187
72615082|NCT01033942|144760220|SUPERIORITY_OR_OTHER|||||||0.5369|||||||Fisher Exact|||||||0.5369
72615083|NCT01033942|144760221|SUPERIORITY_OR_OTHER|||||||0.1524|||||||Fisher Exact|||||||0.1524
72615084|NCT01033942|144760222|SUPERIORITY_OR_OTHER|||||||0.47|||||||Fisher Exact|||||||0.4700
72615085|NCT01033942|144760223|SUPERIORITY_OR_OTHER|||||||0.4686|||||||Fisher Exact|||||||0.4686
72615086|NCT01033942|144760224|SUPERIORITY_OR_OTHER|||||||0.3791|||||||Fisher Exact|||||||0.3791
72615087|NCT01033942|144760225|SUPERIORITY_OR_OTHER|||||||0.7374|||||||Fisher Exact|||||||0.7374
72615088|NCT01033942|144760226|SUPERIORITY_OR_OTHER|||||||0.9363|||||||Fisher Exact|||||||0.9363
72615089|NCT01033942|144760227|SUPERIORITY_OR_OTHER|||||||0.6267|||||||Fisher Exact|||||||0.6267
72615090|NCT01033942|144760228|SUPERIORITY_OR_OTHER|||||||0.6434|TWO_SIDED||||||Fisher Exact|||||||0.6434
72615091|NCT01033942|144760229|SUPERIORITY_OR_OTHER|||||||0.8582|TWO_SIDED||||||Fisher Exact|||||||0.8582
72615092|NCT01033942|144760230|SUPERIORITY_OR_OTHER|||||||0.5778|TWO_SIDED||||||Fisher Exact|||||||0.5778
72615093|NCT01033942|144760231|SUPERIORITY_OR_OTHER|||||||0.9881|TWO_SIDED||||||Fisher Exact|||||||0.9881
72615094|NCT01033942|144760232|SUPERIORITY_OR_OTHER|||||||0.9771|TWO_SIDED||||||Fisher Exact|||||||0.9771
72615095|NCT01033942|144760233|SUPERIORITY_OR_OTHER|||||||0.2301|TWO_SIDED||||||Fisher Exact|||||||0.2301
72615096|NCT02260986|144760250|SUPERIORITY||difference in percentages|26.3|||<|0.0001|TWO_SIDED|95.0|16.34|36.26||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg q2w v Placebo|Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity (IGA baseline values: IGA=3 vs IGA=4). Values after first rescue treatment were set to missing and participants with missing IGA scores at Week 16 were considered as non-responders.||36.26|16.34|<0.0001
72622167|NCT03382873|144774349|SUPERIORITY|||||||0.0001|||||||ANOVA|Intervention sequence and sex were used as independent predictors in the model.||Compares the change for the GLB/GLB intervention sequence to the GLB+/GLB+ intervention sequence (the primary comparison of interest)||||0.0001
72615097|NCT02260986|144760250|SUPERIORITY||difference in percentages|26.8|||<|0.0001|TWO_SIDED|95.0|20.33|33.28||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg qw v Placebo|Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity (IGA baseline values: IGA=3 vs IGA=4). Values after first rescue treatment were set to missing and participants with missing IGA scores at Week 16 were considered as non-responders.||33.28|20.33|<0.0001
72615098|NCT02260986|144760251|SUPERIORITY|Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity (IGA baseline values: IGA=3 vs IGA=4). Values after first rescue treatment use were set to missing and participants with missing EASI score at Week 16 were considered as non-responders.|difference in percentages|45.7|||<|0.0001|TWO_SIDED|95.0|35.72|55.66||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg q2w v Placebo|A hierarchical testing procedure was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.025 level for both comparisons.||55.66|35.72|<0.0001
72615099|NCT02260986|144760251|SUPERIORITY|Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity (IGA baseline values: IGA=3 vs IGA=4). Values after first rescue treatment use were set to missing and participants with missing EASI score at Week 16 were considered as non-responders.|difference in percentages|40.8|||<|0.0001|TWO_SIDED|95.0|33.74|47.81||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg qw v Placebo|A hierarchical testing procedure was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when previous endpoint was statistically significant at 0.025 level for both comparisons.||47.81|33.74|<0.0001
72615100|NCT02260986|144760252|SUPERIORITY||difference in percentages|39.1|||<|0.0001|TWO_SIDED|95.0|28.53|49.65||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg q2w v Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity (IGA baseline values: IGA=3 vs IGA=4). Values after first rescue treatment use were set to missing and participants with missing peak NRS at Week 16 were considered as non-responders.||49.65|28.53|<0.0001
72615101|NCT02260986|144760252|SUPERIORITY||difference in percentages|31.1|||<|0.0001|TWO_SIDED|95.0|23.84|38.39||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg qw v Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity (IGA baseline values: IGA=3 vs IGA=4). Values after first rescue treatment use were set to missing and participants with missing peak NRS at Week 16 were considered as non-responders.||38.39|23.84|<0.0001
72615102|NCT02260986|144760253|SUPERIORITY||difference in percentages|37.9|||<|0.0001|TWO_SIDED|95.0|27.56|48.31||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg q2w v Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity (IGA baseline values: IGA=3 vs IGA=4). Values after first rescue treatment use were set to missing and participants with missing peak NRS at Week 16 were considered as non-responders.||48.31|27.56|<0.0001
72615103|NCT02260986|144760253|SUPERIORITY||difference in percentages|34.7|||<|0.0001|TWO_SIDED|95.0|27.31|42.05||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg qw v Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity (IGA baseline values: IGA=3 vs IGA=4). Values after first rescue treatment use were set to missing and participants with missing peak NRS at Week 16 were considered as non-responders.||42.05|27.31|<0.0001
72615104|NCT02260986|144760254|SUPERIORITY||difference in percentages|23.5|||<|0.0001|TWO_SIDED|95.0|12.72|34.19||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg q2w v Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity (IGA baseline values: IGA=3 vs IGA=4). Values after first rescue treatment were set to missing and participants with missing IGA scores at Week 52 were considered as non-responders.||34.19|12.72|<0.0001
72615105|NCT02260986|144760254|SUPERIORITY||difference in percentages|27.5|||<|0.0001|TWO_SIDED|95.0|20.42|34.58||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg qw v Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity (IGA baseline values: IGA=3 vs IGA=4). Values after first rescue treatment were set to missing and participants with missing IGA scores at Week 52 were considered as non-responders.||34.58|20.42|<0.0001
72615106|NCT02260986|144760255|SUPERIORITY||difference in percentages|43.6|||<|0.0001|TWO_SIDED|95.0|32.5|54.65||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg q2w v Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity (IGA baseline values: IGA=3 vs IGA=4). Values after first rescue treatment use were set to missing and participants with missing EASI score at Week 52 were considered as non-responders.||54.65|32.50|<0.0001
72615107|NCT02260986|144760255|SUPERIORITY||difference in percentages|42.5|||<|0.0001|TWO_SIDED|95.0|34.91|50.06||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg qw v Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity (IGA baseline values: IGA=3 vs IGA=4). Values after first rescue treatment use were set to missing and participants with missing EASI score at Week 52 were considered as non-responders.||50.06|34.91|<0.0001
72615108|NCT02260986|144760256|SUPERIORITY||Least square (LS) mean difference|-26.2|||<|0.0001|TWO_SIDED|95.0|-35.04|-17.43||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg q2w v Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using ANCOVA model with baseline measurements as covariate and the treatment, region and baseline IGA strata as fixed factors.||-17.43|-35.04|<0.0001
72615109|NCT02260986|144760256|SUPERIORITY||LS mean difference|-26.8|||<|0.0001|TWO_SIDED|95.0|-32.83|-20.73||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg qw v Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using ANCOVA model with baseline measurements as covariate and the treatment, region and baseline IGA strata as fixed factors.||-20.73|-32.83|<0.0001
72615110|NCT02260986|144760257|SUPERIORITY||difference in percentages|38.3|||<|0.0001|TWO_SIDED|95.0|26.96|49.66||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg q2w v Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity (IGA baseline values: IGA=3 vs IGA=4). Values after first rescue treatment were set to missing and participants with missing peak NRS at Week 52 were considered as non-responders.||49.66|26.96|<0.0001
72615111|NCT02260986|144760257|SUPERIORITY||difference in percentages|26.1|||<|0.0001|TWO_SIDED|95.0|18.76|33.45||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg qw v Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity (IGA baseline values: IGA=3 vs IGA=4). Values after first rescue treatment were set to missing and participants with missing peak NRS at Week 52 were considered as non-responders.||33.45|18.76|<0.0001
72615112|NCT02260986|144760258|SUPERIORITY||difference in percentages|40.1|||<|0.0001|TWO_SIDED|95.0|28.76|51.35||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg q2w v Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity (IGA baseline values: IGA=3 vs IGA=4). Values after first rescue treatment were set to missing and participants with missing peak NRS at Week 52 were considered as non-responders.||51.35|28.76|<0.0001
72615113|NCT02260986|144760258|SUPERIORITY||difference in percentages|27.3|||<|0.0001|TWO_SIDED|95.0|19.81|34.76||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg qw v Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity (IGA baseline values: IGA=3 vs IGA=4). Values after first rescue treatment were set to missing and participants with missing peak NRS at Week 52 were considered as non-responders.||34.76|19.81|<0.0001
72615114|NCT02260986|144760259|SUPERIORITY||difference in percentages|37.9|||<|0.0001|TWO_SIDED|95.0|27.34|48.4||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg q2w v Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity (IGA baseline values: IGA=3 vs IGA=4). Values after first rescue treatment were set to missing and participants with missing peak NRS at Week 24 were considered as non-responders.||48.40|27.34|<0.0001
72615115|NCT02260986|144760259|SUPERIORITY||difference in percentages|27.7|||<|0.0001|TWO_SIDED|95.0|20.65|34.7||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg qw v Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity (IGA baseline values: IGA=3 vs IGA=4). Values after first rescue treatment were set to missing and participants with missing peak NRS at Week 24 were considered as non-responders.||34.70|20.65|<0.0001
72615116|NCT02260986|144760260|SUPERIORITY||difference in percentages|20.9|||<|0.0001|TWO_SIDED|95.0|10.59|31.15||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg q2w v Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity (IGA baseline values: IGA=3 vs IGA=4). Values after first rescue treatment were set to missing and participants with missing peak NRS at Week 4 were considered as non-responders.||31.15|10.59|<0.0001
72615117|NCT02260986|144760260|SUPERIORITY||difference in percentages|10.7||||0.0021|TWO_SIDED|95.0|4.15|17.31||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg qw v Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity (IGA baseline values: IGA=3 vs IGA=4). Values after first rescue treatment were set to missing and participants with missing peak NRS at Week 4 were considered as non-responders.||17.31|4.15|0.0021
72615118|NCT02260986|144760261|SUPERIORITY||difference in percentages|9.6||||0.0062|TWO_SIDED|95.0|1.61|17.63||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg q2w v Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity (IGA baseline values: IGA=3 vs IGA=4). Values after first rescue treatment were set to missing and participants with missing peak NRS at Week 2 were considered as non-responders.||17.63|1.61|0.0062
72615119|NCT02260986|144760261|SUPERIORITY||difference in percentages|5.5||||0.0344|TWO_SIDED|95.0|0.56|10.51||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg qw v Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity (IGA baseline values: IGA=3 vs IGA=4). Values after first rescue treatment were set to missing and participants with missing peak NRS at Week 2 were considered as non-responders.||10.51|0.56|0.0344
72615120|NCT02260986|144760262|SUPERIORITY||LS mean difference|-1.81|||<|0.0001|TWO_SIDED|95.0|-2.297|-1.322||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg q2w v Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using ANCOVA model with baseline measurements as covariate and the treatment, region and baseline IGA strata as fixed factors.||-1.322|-2.297|<0.0001
72615121|NCT02260986|144760263|SUPERIORITY||LS mean difference|-32.1|||<|0.0001|TWO_SIDED|95.0|-46.37|-17.82||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg q2w v Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using ANCOVA model with baseline measurements as covariate and the treatment, region and baseline IGA strata as fixed factors.||-17.82|-46.37|<0.0001
72615122|NCT02260986|144760264|SUPERIORITY||LS mean difference|-18.38|||<|0.0001|TWO_SIDED|95.0|-22.583|-14.187||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg q2w v Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using ANCOVA model with baseline measurements as covariate and the treatment, region and baseline IGA strata as fixed factors.||-14.187|-22.583|<0.0001
72615123|NCT02260986|144760265|SUPERIORITY||LS mean difference|-27.7|||<|0.0001|TWO_SIDED|95.0|-33.46|-21.9||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg q2w v Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using ANCOVA model with baseline measurements as covariate and the treatment, region and baseline IGA strata as fixed factors.||-21.9|-33.46|<0.0001
72615124|NCT02260986|144760266|SUPERIORITY||LS mean difference|-4.2|||<|0.0001|TWO_SIDED|95.0|-5.31|-3.02||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg q2w v Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using ANCOVA model with baseline measurements as covariate and the treatment, region and baseline IGA strata as fixed factors.||-3.02|-5.31|<0.0001
72615125|NCT02260986|144760267|SUPERIORITY||LS mean difference|-7.4|||<|0.0001|TWO_SIDED|95.0|-8.85|-5.93||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg q2w v Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using ANCOVA model with baseline measurements as covariate and the treatment, region and baseline IGA strata as fixed factors.||-5.93|-8.85|<0.0001
72615126|NCT02260986|144760268|SUPERIORITY||LS mean difference|-1.0||||0.1596|TWO_SIDED|95.0|-2.27|0.37||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg q2w v Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using ANCOVA model with baseline measurements as covariate and the treatment, region and baseline IGA strata as fixed factors.||0.37|-2.27|0.1596
72615127|NCT02175758|144760322|EQUIVALENCE|Equivalence was determined if the 90% confidence intervals (CI) were within the predefined equivalence boundaries of 50% to 200% for all age groups.|Percentage Geometric Mean Ratio|129.48|||||TWO_SIDED|90.0|109.96|152.48||||||AUCtau of GS-331007 for the 12 to \< 18 Years old group in the PK Lead-in Phase was compared against historical data collected in adult Phase 2/3 studies.||152.48|109.96|
72615128|NCT02175758|144760322|EQUIVALENCE|Equivalence was determined if the 90% CIs were within the predefined equivalence boundaries of 50% to 200% for all age groups.|Percentage Geometric Mean Ratio|109.8|||||TWO_SIDED|90.0|93.25|129.29||||||AUCtau of GS-331007 for the 6 to \< 12 Years Old group in the PK Lead-in Phase was compared against historical data collected in adult Phase 2/3 studies.||129.29|93.25|
72615129|NCT02175758|144760322|EQUIVALENCE|Equivalence was determined if the 90% CIs were within the predefined equivalence boundaries of 50% to 200% for all age groups.|Percentage Geometric Mean Ratio|149.67|||||TWO_SIDED|90.0|127.12|176.21||||||AUCtau of GS-331007 for the 3 to \< 6 Years Old group in the PK Lead-in Phase was compared against historical data collected in adult Phase 2/3 studies.||176.21|127.12|
72615130|NCT02175758|144760324|SUPERIORITY||||||<|0.001|||||||2-sided exact 1-sample binomial test|||The SVR12 rate for the 12 to \< 18 Years Old group was compared with the historical SVR12 rate of 80% using a 2-sided exact 1-sample binomial test at the 0.05 significance level. If superiority was demonstrated in the 12 to \< 18 Years Old group, then the SVR12 rate for participants aged 3 to \< 12 years would be compared with 80% at the 0.05 significance level.||||<0.001
72615131|NCT02175758|144760324|SUPERIORITY||||||<|0.001|||||||2-sided exact 1-sample binomial test|||The SVR12 rate for the 3 to \< 12 Years Old group was compared with the historical SVR12 rate of 80% using a 2-sided exact 1-sample binomial test at the 0.05 significance level.||||<0.001
72615132|NCT00429299|144760369|NON_INFERIORITY_OR_EQUIVALENCE|An exploratory comparison between the combined two single anti-HER2 arms and the dual anti-HER2 arm was performed (Arm 3 versus Arms 1 and 2).|percentage of participants|25.0||||0.019||90.0|13.1|36.9||Exploratory analysis|Chi-squared||The estimated value represents the percentage of particpants in the CT plus trastuzumab treatment group with pathological complete response.|||36.9|13.1|0.019
72615133|NCT00429299|144760369|SUPERIORITY_OR_OTHER||percentage of participants|26.3||||||90.0|14.5|38.1|||||The estimated value represents the percentage of particpants in the CT plus lapatinib 1500 mg treatment group with pathological complete response.|||38.1|14.5|
72615134|NCT00429299|144760369|SUPERIORITY_OR_OTHER||percentage of participants|46.7|||||TWO_SIDED|90.0|34.4|58.9|||||The estimated value represents the percentage of particpants in the CT plus traztuzumab plus lapatinib 1000 mg treatment group with pathological complete response.|||58.9|34.4|
72615135|NCT04871113|144760386|OTHER||Emax|-1.848|||||TWO_SIDED|95.0|-2.225|-1.472|||||Emax is defined as maximum response.|||-1.472|-2.225|
72615136|NCT04871113|144760386|OTHER||EC50|68.578|||||TWO_SIDED|95.0|15.866|121.29|||||EC50 is defined as the dose (in mg) that attains the 50% of the maximal effect.|||121.290|15.866|
72615137|NCT04871113|144760386|OTHER||s2e|0.257|||||TWO_SIDED|95.0|0.145|0.368|||||e is defined as random error assumed to be normally distributed with mean zero and constant variance (s2).|||0.368|0.145|
72615138|NCT01257542|144760395|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.83||||0.252|TWO_SIDED|95.0|0.59|1.15||p-value was calculated using negative binomial regression model with treatment, site and baseline of cough count terms with log (exposure time) as the offset parameter.|Negative binomial regression|||Odds Ratio and corresponding 95 percent (%) confidence interval (CI) were assessed from the negative binomial regression model.||1.15|0.59|0.252
72615139|NCT01257542|144760396|SUPERIORITY_OR_OTHER||LS mean difference|-0.26||||0.134|TWO_SIDED|95.0|-0.6|0.08||p-value was calculated using ANOVA model with treatment, site and baseline cough severity verbal rating scale terms.|ANOVA|||Treatment difference and corresponding 95% CI were calculated based on least-square (LS) means from analysis of variance (ANOVA) model.||0.08|-0.60|0.134
72615140|NCT01257542|144760397|SUPERIORITY_OR_OTHER||LS mean difference|-0.06||||0.768|TWO_SIDED|95.0|-0.45|0.33||p-value was calculated using ANOVA model with treatment, site and baseline cough severity verbal rating scale terms.|ANOVA|||1 hour: treatment difference and corresponding 95% CI were calculated based on LS means from ANOVA model.||0.33|-0.45|0.768
72615141|NCT01257542|144760397|SUPERIORITY_OR_OTHER||LS mean difference|-0.2||||0.358|TWO_SIDED|95.0|-0.64|0.23||p-value was calculated using ANOVA model with treatment, site and baseline cough severity verbal rating scale terms.|ANOVA|||2 hours: treatment difference and corresponding 95% CI were calculated based on LS means from ANOVA model.||0.23|-0.64|0.358
72615142|NCT01257542|144760397|SUPERIORITY_OR_OTHER||LS mean difference|-0.32||||0.139|TWO_SIDED|95.0|-0.74|0.1||p-value was calculated using ANOVA model with treatment, site and baseline cough severity verbal rating scale terms.|ANOVA|||3 hours: treatment difference and corresponding 95% CI were calculated based on LS means from ANOVA model.||0.10|-0.74|0.139
72615143|NCT01257542|144760397|SUPERIORITY_OR_OTHER||LS mean difference|-0.21||||0.364|TWO_SIDED|95.0|-0.68|0.25||p-value was calculated using ANOVA model with treatment, site and baseline cough severity verbal rating scale terms.|ANOVA|||4 hours: treatment difference and corresponding 95% CI were calculated based on LS means from ANOVA model.||0.25|-0.68|0.364
72615144|NCT01257542|144760397|SUPERIORITY_OR_OTHER||LS mean difference|-0.46||||0.039|TWO_SIDED|95.0|-0.9|-0.02||p-value was calculated using ANOVA model with treatment, site and baseline cough severity verbal rating scale terms.|ANOVA|||5 hours: treatment difference and corresponding 95% CI were calculated based on LS means from ANOVA model.||-0.02|-0.90|0.039
72615145|NCT01257542|144760397|SUPERIORITY_OR_OTHER||LS mean difference|-0.29||||0.206|TWO_SIDED|95.0|-0.75|0.16||p-value was calculated using ANOVA model with treatment, site and baseline cough severity verbal rating scale terms.|ANOVA|||6 hours: treatment difference and corresponding 95% CI were calculated based on LS means from ANOVA model.||0.16|-0.75|0.206
72615146|NCT01257542|144760398|SUPERIORITY_OR_OTHER||LS mean difference|-0.49||||0.304|TWO_SIDED|95.0|-1.43|0.45||p-value was calculated using ANOVA model with treatment, site and baseline cough severity numerical rating scale terms.|ANOVA|||Treatment difference and corresponding 95% CI were calculated based on LS means from ANOVA model.||0.45|-1.43|0.304
72615147|NCT01257542|144760399|SUPERIORITY_OR_OTHER||LS mean difference|-0.03||||0.954|TWO_SIDED|95.0|-1.03|0.97||p-value was calculated using ANOVA model with treatment, site and baseline cough severity numerical rating scale terms.|ANOVA|||1 hour: treatment difference and corresponding 95% CI were calculated based on LS means from ANOVA model.||0.97|-1.03|0.954
72615148|NCT01257542|144760399|SUPERIORITY_OR_OTHER||LS mean difference|-0.44||||0.426|TWO_SIDED|95.0|-1.54|0.65||p-value was calculated using ANOVA model with treatment, site and baseline cough severity numerical rating scale terms.|ANOVA|||2 hours: treatment difference and corresponding 95% CI were calculated based on LS means from ANOVA model.||0.65|-1.54|0.426
72615149|NCT01257542|144760399|SUPERIORITY_OR_OTHER||LS mean difference|-0.45||||0.396|TWO_SIDED|95.0|-1.49|0.6||p-value was calculated using ANOVA model with treatment, site and baseline cough severity numerical rating scale terms.|ANOVA|||3 hours: treatment difference and corresponding 95% CI were calculated based on LS means from ANOVA model.||0.60|-1.49|0.396
72615150|NCT01257542|144760399|SUPERIORITY_OR_OTHER||LS mean difference|-0.49||||0.402|TWO_SIDED|95.0|-1.63|0.66||p-value was calculated using ANOVA model with treatment, site and baseline cough severity numerical rating scale terms.|ANOVA|||4 hours: treatment difference and corresponding 95% CI were calculated based on LS means from ANOVA model.||0.66|-1.63|0.402
72615151|NCT01257542|144760399|SUPERIORITY_OR_OTHER||LS mean difference|-0.69||||0.204|TWO_SIDED|95.0|-1.75|0.38||p-value was calculated using ANOVA model with treatment, site and baseline cough severity numerical rating scale terms.|ANOVA|||5 hours: treatment difference and corresponding 95% CI were calculated based on LS means from ANOVA model.||0.38|-1.75|0.204
72615152|NCT01257542|144760399|SUPERIORITY_OR_OTHER||LS mean difference|-0.84||||0.179|TWO_SIDED|95.0|-2.06|0.39||p-value was calculated using ANOVA model with treatment, site and baseline cough severity numerical rating scale terms.|ANOVA|||6 hours: treatment difference and corresponding 95% CI were calculated based on LS means from ANOVA model.||0.39|-2.06|0.179
72615153|NCT01257542|144760400|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.09||||0.523|TWO_SIDED|95.0|-0.21|0.39||p-value was calculated from the Cochran-Mantel-Haenszel (CMH) test with modified ridit scores controlling site.|Cochran-Mantel-Haenszel|||Treatment difference and the associated 95% CI were based on the weighted Gamma statistics.||0.39|-0.21|0.523
72615154|NCT01257542|144760401|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.06||||0.796|TWO_SIDED|95.0|-0.35|0.24||p-value was calculated from the CMH test with modified ridit scores controlling site.|Cochran-Mantel-Haenszel|||Treatment difference and the associated 95% CI were based on the weighted Gamma statistics.||0.24|-0.35|0.796
72615155|NCT00693303|144760411|SUPERIORITY_OR_OTHER|||||||0.27||95.0|||||t-test, 2 sided|||||||.27
72615156|NCT02202616|144760412|OTHER||Mean Difference (Final Values)|0.17|STANDARD_DEVIATION|0.34|||TWO_SIDED|95.0|0.14|0.21|||Descriptive Statistics with 95% CI|The mean change from baseline along with the 95% confidence interval used to assess the precision of the estimate||||0.21|0.14|
72615157|NCT02202616|144760413|OTHER||Mean Difference (Final Values)|0.14|STANDARD_DEVIATION|0.278|||TWO_SIDED|95.0|0.11|0.17|||Descriptive Statistics with 95% CI|The mean change from baseline along with the 95% confidence interval used to assess the precision of the estimate||||0.17|0.11|
72615158|NCT02202616|144760414|OTHER||Mean Difference (Final Values)|2.0|STANDARD_DEVIATION|2.47|||TWO_SIDED|95.0|1.74|2.3|||Standard Descriptive Statistics|The estimated mean change from baseline and corresponding 95% confidence intervals will be displayed for each visit.||Week 4||2.30|1.74|
72615159|NCT02202616|144760414|OTHER||Mean Difference (Final Values)|2.5|STANDARD_DEVIATION|2.92|||TWO_SIDED|95.0|2.21|2.85|||Standard Descriptive Statistics|The estimated mean change from baseline and corresponding 95% confidence intervals will be displayed for each visit||Week 16||2.85|2.21|
72615160|NCT02202616|144760415|OTHER||Mean Difference (Final Values)|-5.0|STANDARD_DEVIATION|6.25|||TWO_SIDED|95.0|-5.7|-4.3|||standard descriptive statistics|The estimated mean change from baseline to Week 4 along with the 95% confidence interval||Week 4||-4.3|-5.7|
72615161|NCT02202616|144760415|OTHER||Mean Difference (Final Values)|-6.5|STANDARD_DEVIATION|7.03|||TWO_SIDED|95.0|-7.3|-5.7|||standard descriptive statistics|The estimated mean change from baseline to Week 4 along with the 95% confidence interval||Week 16||-5.7|-7.3|
72615162|NCT04327271|144760418|NON_INFERIORITY|Non-inferiority margin of -0.25% set as lower bound of 95% CI for the maximum mean difference between the proportion of cumulative AEs between control and 2wT arms to conclude that 2wT is non-inferior. This margin was set considering the average AE rate of 0.5% from routine SSA MC programs at scale, and assuming that 2wT increases AE ascertainment to 2.0%, similar to 1.9% of Zimbabwe RCT and the widely-accepted standard 2% AE rate.|Mean Difference (Final Values)|1.2|||||ONE_SIDED|95.0|-0.09|||||||With 10% loss to follow-up (LTFU), a sample size of 1104 men provides at least 80% power to rule out a decrease in AE ascertainment of more than 0.25% based on the lower bound of the one-sided 95% CI. The one tailed alpha was set 0.05.|||-.09|
72615163|NCT04327271|144760419|SUPERIORITY||Mean Difference (Final Values)|1.12||||0.001|TWO_SIDED|95.0|1.03|1.21|||Fisher Exact|||The mean number of in-person clinic visit, excluding non-study visits, were compared between the two arms using a t-test. The proportion of potential AEs was calculated as number of potential AE responses divided by the total number of daily responses (no AE and potential AE). A superiority test was performed on the safety outcomes using a two-sided 95% confidence interval and p-value using Fisher's exact test.||1.21|1.03|0.001
72615164|NCT01479530|144760434|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|0.22||0.0228|TWO_SIDED|95.0|-0.92|-0.07|||ANCOVA|||||-0.07|-0.92|0.0228
72615165|NCT01479530|144760435|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.41|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001|TWO_SIDED|95.0|-0.61|-0.22|||ANCOVA|||||-0.22|-0.61|<0.0001
72615166|NCT01479530|144760436|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.01|STANDARD_ERROR_OF_MEAN|0.37||0.0075|TWO_SIDED|95.0|-1.75|-0.27|||ANCOVA|||||-0.27|-1.75|0.0075
72615167|NCT01479530|144760437|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-1.6|STANDARD_ERROR_OF_MEAN|0.74||0.0317|TWO_SIDED|95.0|-3.05|-0.14|||ANCOVA|||||-0.14|-3.05|0.0317
72615168|NCT00303628|144760438|SUPERIORITY_OR_OTHER_LEGACY|||||||0.876|TWO_SIDED|||||Stratified log rank test. The above P value was for one-sided test|Log Rank|||||||0.876
72615169|NCT00303628|144760439|SUPERIORITY_OR_OTHER_LEGACY|||||||0.299|TWO_SIDED|||||two-sided stratified log rank test p value|Log Rank|||||||0.299
72615170|NCT03487445|144760448|SUPERIORITY|The statistical analysis comprised a 2-step testing strategy. The first test, carried out at an alpha level of 0.025, determined whether the proportion of responders (patients with a PRU value \<100) was ≥ 50% (null hypothesis: proportion of responders \<50%) and is reported below. The second step for the Selatogrel 8 mg is described in statistical analysis 2: In this second analysis the subsequent null hypothesis of treatment effect less or equal to 85% was tested for the 8 mg dose.|||||<|0.001||||||P-value for hypotheses (H0: p \<= 50% vs. H1: p \> 50%)|one-sided z-test|A p-value significance level was set to 0.025.||The main analysis (mFAS, treatment dose as received) of treatment effect on the primary endpoint was conducted independently for each dose.||||<0.001
72615171|NCT03487445|144760448|SUPERIORITY|This statistical analysis reports the second of the 2-step testing strategy. This second test for the 8 mg Selatogrel dose, carried out at an alpha level of 0.025, determined whether the proportion of responders (patients with a PRU value \<100) was ≥ 85% (null hypothesis: proportion of responders \<85%).||||||0.142||||||P-value for hypotheses (H0: p \<= 85% vs. H1: p \> 85%)|one-sided z-test|A p-value significance level was set to 0.025, an overall level of 0.05 and adjusted for multiplicity using the Bonferroni approach.||The main analysis (mFAS, treatment dose as received) of treatment effect on the primary endpoint was conducted independently for each dose.||||0.142
72615172|NCT03487445|144760448|SUPERIORITY|The statistical analysis comprised a 2-step testing strategy. The first test, carried out at an alpha level of 0.025, determined whether the proportion of responders (patients with a PRU value \<100) was ≥ 50% (null hypothesis: proportion of responders \<50%) and is reported below. The second step for the Selatogrel 16 mg is described in statistical analysis 4: In this second analysis the subsequent null hypothesis of treatment effect less or equal to 85% was tested for the 16 mg dose.|||||<|0.0001||||||P-value for hypotheses (H0: p \<= 50% vs. H1: p \> 50%)|one-sided z-test|A p-value significance level was set to 0.025.||The main analysis (mFAS, treatment dose as received) of treatment effect on the primary endpoint was conducted independently for each dose.||||<0.0001
72615173|NCT03487445|144760448|SUPERIORITY|This statistical analysis reports the second of the 2-step testing strategy. This second test for the 16 mg Selatogrel dose, carried out at an alpha level of 0.025, determined whether the proportion of responders (patients with a PRU value \<100) was ≥ 85% (null hypothesis: proportion of responders \<85%).||||||0.009||||||P-value for hypotheses (H0: p \<= 85% vs. H1: p \> 85%)|one-sided z-test|A p-value significance level was set to 0.025, an overall level of 0.05 and adjusted for multiplicity using the Bonferroni approach.||The main analysis (mFAS, treatment dose as received) of treatment effect on the primary endpoint was conducted independently for each dose.||||0.009
72615174|NCT03487445|144760449|SUPERIORITY|||||||0.228||||||P-value for hypotheses (H0: p \<= 85% versus H1: p \> 85%)|One-sided Z-test|||As per the main analysis (mFAS) the supporting analysis on the per-protocol set this analysis of treatment effect was conducted independently for each dose, i.e., 8 and 16 mg.||||0.2280
72615175|NCT03487445|144760449|SUPERIORITY|||||||0.0201||||||P-value for hypotheses (H0: p \<= 85% versus H1: p \> 85%)|One-sided Z-test|||As per the main analysis (mFAS) the supporting analysis on the per-protocol set this analysis of treatment effect was conducted independently for each dose, i.e., 8 and 16 mg.||||0.0201
72615176|NCT03301714|144760455|EQUIVALENCE|equivalence analysis|Mean Difference (Final Values)|7.62||||0|TWO_SIDED|95.0||||baseline demographics, correlated errors due to repeated measures, and bias due to lost to follow-up were accounted for via Generalized Estimating Equation (statistical threshold \<0.01)|Regression, Linear||Mean change difference in oral health related quality of life among control, intervention 1: group-based oral health education and intervention 2: individual-based oral health education using motivational interviewing.|||||.000
72615177|NCT02949934|144760490|SUPERIORITY|||||||0.013|||||||ANCOVA|Covariates were age, baseline AUDIT score, baseline drinks per day, and whether participant participated before vs. during the COVID-19 pandemic.||Analysis was an ANCOVA testing the interaction between rs4680 genotype and medication group.||||0.013
72615178|NCT02949934|144760491|SUPERIORITY|||||||0.014|||||||ANCOVA|Covariates were age, baseline AUDIT score, and baseline drinks per day.||Analysis was an ANCOVA testing the interaction between rs4680 genotype and medication group||||0.014
72615179|NCT02949934|144760492|SUPERIORITY|||||||0.062|||||||Mixed Models Analysis|Linear mixed model testing interaction between rs4680 genotype, medication group, and time, controlling for scanner||||||0.062
72615180|NCT02949934|144760493|SUPERIORITY|||||||0.83|||||||Mixed Models Analysis|Linear mixed model testing interaction between rs4680 genotype, medication group, and time, controlling for scanner||||||0.83
72615181|NCT02949934|144760493|SUPERIORITY|||||||0.026|||||||Mixed Models Analysis|Linear mixed model testing interaction between medication group and time, controlling for scanner||||||0.026
72615182|NCT04167670|144760506|NON_INFERIORITY|P-value based on a Farrington and Manning test with a noninferiority margin of 10%.|Percentage Difference|-0.3||||0.0037|TWO_SIDED|95.0|-7.39|6.76|||Farrington and Manning test||The confidence interval of the difference in H pylori eradication rates between vonoprazan dual therapy and lansoprazole triple therapy was calculated via the Miettinen and Nurminen method.|Noninferiority of vonoprazan dual therapy to lansoprazole triple therapy.||6.76|-7.39|0.0037
72615183|NCT04167670|144760506|NON_INFERIORITY|P-value based on a Farrington and Manning test with a noninferiority margin of 10%.|Percentage Difference|5.9|||<|0.0001|TWO_SIDED|95.0|-0.75|12.62|||Farrington and Manning test||The confidence interval of the difference in H pylori eradication rates between vonoprazan triple therapy and lansoprazole triple therapy was calculated via the Miettinen and Nurminen method.|Noninferiority of vonoprazan triple therapy to lansoprazole triple therapy.||12.62|-0.75|<0.0001
72615184|NCT04167670|144760507|SUPERIORITY|P-value based on a Farrington and Manning test with the null hypothesis difference ≤0 versus the alternative hypothesis difference \>0.|Percentage Difference|37.7|||<|0.0001|TWO_SIDED|95.0|20.54|52.56|||Farrington and Manning test||The confidence interval of the difference in H pylori eradication rates between vonoprazan dual therapy and lansoprazole triple therapy was calculated via the Miettinen and Nurminen method.|Superiority of vonoprazan dual therapy to lansoprazole triple therapy.||52.56|20.54|<0.0001
72615185|NCT04167670|144760507|SUPERIORITY|P-value based on a Farrington and Manning test with the null hypothesis difference ≤0 versus the alternative hypothesis difference \>0.|Percentage Difference|33.8|||<|0.0001|TWO_SIDED|95.0|17.74|48.12|||Farrington and Manning test||The confidence interval of the difference in H pylori eradication rates between vonoprazan triple therapy and lansoprazole triple therapy was calculated via the Miettinen and Nurminen method.|Superiority of vonoprazan triple therapy to lansoprazole triple therapy.||48.12|17.74|<0.0001
72615186|NCT04167670|144760508|SUPERIORITY|P-value based on a Farrington and Manning test with the null hypothesis difference ≤0 versus the alternative hypothesis difference \>0.|Percentage Difference|8.7||||0.0063|TWO_SIDED|95.0|1.86|15.44|||Farrington and Manning test||The confidence interval of the difference in H pylori eradication rates between vonoprazan dual therapy and lansoprazole triple therapy was calculated via the Miettinen and Nurminen method.|Superiority of vonoprazan dual therapy to lansoprazole triple therapy.||15.44|1.86|0.0063
72615187|NCT04167670|144760508|SUPERIORITY|P-value based on a Farrington and Manning test with the null hypothesis difference ≤0 versus the alternative hypothesis difference \>0.|Percentage Difference|12.3||||0.0001|TWO_SIDED|95.0|5.72|18.81|||Farrington and Manning test|||Superiority of vonoprazan triple therapy to lansoprazole triple therapy.|The confidence interval of the difference in H pylori eradication rates between vonoprazan triple therapy and lansoprazole triple therapy was calculated via the Miettinen and Nurminen method.|18.81|5.72|0.0001
72615188|NCT01115231|144760573|OTHER|multivariable logistic regression model|Odds Ratio (OR)|2.03|||||TWO_SIDED|95.0|0.93|4.42||||||||4.42|0.93|
72615189|NCT01771913|144760584|SUPERIORITY_OR_OTHER|||||||0.31|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.310
72615190|NCT01771913|144760585|SUPERIORITY_OR_OTHER|||||||0.026|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.026
72615191|NCT01771913|144760586|SUPERIORITY_OR_OTHER|||||||0.103|TWO_SIDED||||||Fisher Exact|||||||0.103
72615192|NCT04307394|144760588|SUPERIORITY|||||||0.957|||||||t-test, 2 sided|||||||0.957
72615193|NCT03928327|144760593|OTHER||Geometric Least Squares (LS) Mean Ratio|2.86|||||TWO_SIDED|90.0|2.48|3.3|||||Linear mixed-effects model was used for analysis, using fixed-effect(treatment), random-effect(participants). Geometric mean ratios(GMR), 90% confidence interval(CI) calculated using exponentiation of treatment least squares means(LSMs) difference.|||3.30|2.48|
72615194|NCT03928327|144760594|OTHER||Geometric LS Mean Ratio|0.08|||||TWO_SIDED|90.0|0.07|0.11|||||Linear mixed-effects model was used for analysis, using fixed-effect (treatment) and random-effect (participants). GMR and 90% CI was calculated using exponentiation of treatment LSMs difference.|||0.11|0.07|
72615195|NCT03928327|144760595|OTHER||Geometric LS Mean Ratio|6.27|||||TWO_SIDED|90.0|5.2|7.56|||||Linear mixed-effects model was used for analysis, using fixed-effect (treatment) and random-effect (participants). GMR and 90% CI was calculated using exponentiation of treatment LSMs difference.|||7.56|5.20|
72615196|NCT03928327|144760596|OTHER||Geometric LS Mean Ratio|0.05|||||TWO_SIDED|90.0|0.04|0.07|||||Linear mixed-effects model was used for analysis, using fixed-effect (treatment) and random-effect (participants). GMR and 90% CI was calculated using exponentiation of treatment LSMs difference.|||0.07|0.04|
72615197|NCT00407511|144760600|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||t-test, 2 sided|||End of treatment/last observation carried forward (EOT/LOCF): value consists of the mean of the last 7 post-baseline visits scores. Mean change: the arithmetic mean change and p-value from the single sample t-test. If \< = 7 and \> = 4 post-baseline scores were available, the mean pain score was computed using the available scores. The mean was not calculated if there were less than 4 post-baseline scores prior to study termination.||||< 0.0001
72615198|NCT00407511|144760601|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.2|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001||95.0|-3.6|-2.8|||Mixed Models Analysis||Parameter estimate: Mean Difference (Final Values) = least squares mean.|Week 4||-2.8|-3.6|< 0.0001
72615199|NCT00407511|144760601|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.9|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001||95.0|-4.3|-3.5|||Mixed Models Analysis||Parameter estimate: Mean Difference (Final Values) = least squares mean.|Week 8||-3.5|-4.3|< 0.0001
72615200|NCT00407511|144760601|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.1|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001||95.0|-4.5|-3.7|||Mixed Models Analysis||Parameter estimate: Mean Difference (Final Values) = least squares mean.|Week 12||-3.7|-4.5|< 0.0001
72615201|NCT00407511|144760602|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.2|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001||95.0|-4.7|-3.7|||Mixed Models Analysis||Parameter estimate: Mean Difference (Final Values) = least squares mean.|Week 8, FAS. Week 8: subjects were only included if their visit fell within the computed week (49 to 63 days).||-3.7|-4.7|< 0.0001
72554818|NCT03393208|144641389|EQUIVALENCE|Analysis was performed with Equivalence Acceptance Range for 90% Confidence Interval (CI) as 80.00% - 125.00%|Ratio of Geometric LS Mean Percentage|99.62||||||90.0|92.69|106.77||||||Statistical Comparison of Treatment A Versus Treatment B in Fasting state||106.77|92.69|
72554819|NCT03393208|144641389|EQUIVALENCE|Analysis was performed with Equivalence Acceptance Range for 90% Confidence Interval (CI) as 80.00% - 125.00%|Ratio of Geometric LS Mean Percentage|101.5||||||90.0|93.72|109.92||||||Statistical Comparison of Treatment A Versus Treatment B in Fed state||109.92|93.72|
72554820|NCT03393208|144641390|EQUIVALENCE|Analysis was performed with Equivalence Acceptance Range for 90% Confidence Interval (CI) as 80.00% - 125.00%|Median Difference|0.0|||||TWO_SIDED|90.0|-0.25|0.25||||||Statistical Comparison of Treatment A Versus Treatment B in Fasting state||0.25|-0.25|
72554821|NCT03393208|144641390|EQUIVALENCE|Analysis was performed with Equivalence Acceptance Range for 90% Confidence Interval (CI) as 80.00% - 125.00%|Median Difference|0.25||||||90.0|-0.25|0.5||||||Statistical Comparison of Treatment A Versus Treatment B in Fed state||0.50|-0.25|
72554822|NCT03393208|144641392|EQUIVALENCE|Analysis was performed with Equivalence Acceptance Range for 90% Confidence Interval (CI) as 80.00% - 125.00%|Ratio of Geometric LS Mean Percentage|101.26||||||90.0|94.33|108.69||||||Statistical Comparison of Treatment A Versus Treatment B in Fasting state||108.69|94.33|
72554823|NCT03393208|144641392|EQUIVALENCE|Analysis was performed with Equivalence Acceptance Range for 90% Confidence Interval (CI) as 80.00% - 125.00%|Ratio of Geometric LS Mean Percentage|98.17|||||TWO_SIDED|90.0|91.61|105.21||||||Statistical Comparison of Treatment A Versus Treatment B in Fed state||105.21|91.61|
72554824|NCT01848938|144641405|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Linear Mixed Models analysis|||analysis between groups||||<0.001
72554825|NCT01848938|144641406|SUPERIORITY_OR_OTHER|||||||0.005|||||||Linear Mixed Models analysis|||analysis between groups||||0.005
72554826|NCT01848938|144641407|SUPERIORITY_OR_OTHER|||||||0.023|||||||Wilcoxon (Mann-Whitney)|||analysis between groups||||0.023
72554827|NCT01848938|144641409|SUPERIORITY_OR_OTHER|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||analysis between groups||||0.001
72554828|NCT01848938|144641410|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||analysis between groups||||<0.001
72554829|NCT00207090|144641413|SUPERIORITY_OR_OTHER_LEGACY||Point estimate|0.912|||||TWO_SIDED|90.0|0.751|1.106||||||Two-way analyses of variance were performed on log-transformed values of Cmax. The factors in the analyses were participant and day. Point estimates and 90% confidence intervals for means and differences between means on the log scale were exponentiated to obtain estimates for geometric means and ratio of geometric means on the original scale.||1.106|0.751|
72554830|NCT00207090|144641414|SUPERIORITY_OR_OTHER_LEGACY||Point estimate|0.566|||||TWO_SIDED|90.0|0.482|0.664||||||Two-way analyses of variance were performed on log-transformed values of (AUC \[INF\]). The factors in the analyses were participant and day. Point estimates and 90% confidence intervals for means and differences between means on the log scale were exponentiated to obtain estimates for geometric means and ratio of geometric means on the original scale.||0.664|0.482|
72554831|NCT00304187|144641441|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|||||||<.05
72554832|NCT00099047|144641443|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.05|STANDARD_DEVIATION|0.05||0.23|TWO_SIDED||||||SAS version 8||36 evaluable patients randomized 1:1 to each treatment was planned in order to have \>77% power to detect differences in above parameters equal to or greater than one standard deviation, based on a 2-sided Wilcoxon rank-sum test with .05 Type I error.|||||.23
72554833|NCT00651820|144641444|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0|||||Paired-Prentice Wilcoxon (PPW)|Time to complete wound closure Drug(T1)and Vehicle(T2)Hypothesis, Ho: T1=T2,using paired Prentice-Wilcoxon at significant level of 5%, 2-sided.||Each subject served as their own control, each receiving duplicate dermatome-induced wounds with 1 wound treated with active drug and the other treated with vehicle. Mean time to wound closure was calculated for the wounds treated with drug, the wounds treated with vehicle, and an over-all mean time to wound closure||||<0.05
72554834|NCT00651820|144641445|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.2|||<|0.05|TWO_SIDED|95.0|||||t-test, 2 sided|||Stiffness: Paired t-test and Wilcoxon signed rank test were used for testing any significant differences (Sig. diff.) between the two treatments||||<0.05
72554835|NCT00651820|144641445|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.88|||<|0.05|TWO_SIDED|95.0|||||t-test, 2 sided|||Energy Absorption: Paired t-test and Wilcoxon signed rank test were used for testing any significant differences (Sig. diff.) between the two treatments||||<0.05
72554836|NCT03374176|144641464|EQUIVALENCE||Mean Difference (Net)|0.05|STANDARD_DEVIATION|1.0|<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||||chi-square|||<0.05
72554837|NCT01302548|144641469|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0833|STANDARD_DEVIATION|0.8609||0.797|TWO_SIDED|95.0|-0.5738|0.7405||This is unadjusted.|t-test, 2 sided|Degrees of freedom = 28||"Ho: There is not a significant difference between the use of IRRISEPT solution and the usual care methods on abscess healing.~This study did not enroll an adequate number of patients to meet sufficient power."||.7405|-.5738|.7970
72554838|NCT01302548|144641470|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.2364||||0.3575|TWO_SIDED|95.0|0.0239|2.3394||This is unadjusted.|Fisher Exact|Cell (1,1) Frequency (F) = 13||"Ho: There is not a significant difference between the proportion of patients requiring antibiotics after the use of IRRISEPT solution vs. the usual care methods on abscess healing.~This study did not enroll an adequate number of patients to meet sufficient power."||2.3394|.0239|.3575
72554839|NCT01302548|144641471|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.4|STANDARD_DEVIATION|0.5477||0.5415|TWO_SIDED|95.0|-2.0659|1.2659||This is unadjusted.|t-test, 2 sided|Degrees of freedom = 4||"Ho: There is not a significant difference between the use of IRRISEPT solution and the usual care methods on abscess healing in patients that are MRSA positive.~This study did not enroll an adequate number of patients to meet sufficient power."||1.2659|-2.0659|.5415
72554840|NCT01237054|144641474|SUPERIORITY|||||||0.024||||||The reported p-value is representative of the difference in levels of Ang2 in both groups.|Wilcoxon rank sum test|||||||0.024
72554841|NCT01237054|144641474|SUPERIORITY|||||||0.055||||||The reported p-value is representative of the difference in levels of G-CSF in both groups.|Wilcoxon rank sum test|||||||0.055
72554842|NCT01237054|144641474|SUPERIORITY|||||||0.055||||||The reported p-value is representative of the difference in levels of Follistatin in both groups.|Wilcoxon rank sum test|||||||0.055
72554843|NCT01237054|144641474|SUPERIORITY|||||||0.0098||||||The reported p-value is representative of the difference in levels of HGF in both groups.|Wilcoxon rank sum test|||||||0.0098
72554844|NCT01237054|144641474|SUPERIORITY|||||||0.02||||||The reported p-value is representative of the difference in levels of VEGF-A in both groups.|Wilcoxon rank sum test|||||||0.02
72554845|NCT01237054|144641475|OTHER|Other, trend test.||||||0.008|||||||Jonckheere-Terpstra test for trend|||||||0.008
72554846|NCT01237054|144641476|OTHER|Other, trend test.||||||0.15||||||The reported p-value is representative of the difference in levels of Kep between MGUS and SMM+MM.|Jonckheere-Terpstra test for trend|||||||0.15
72554847|NCT01237054|144641476|OTHER|Other, trend test.||||||0.33||||||The reported p-value is representative of the difference in levels of Ktrans between MGUS and SMM+MM.|Jonckheere-Terpstra test for trend|||||||0.33
72554848|NCT01237054|144641477|SUPERIORITY|||||||0.08|||||||Wilcoxon rank sum test|||||||0.08
72554849|NCT01237054|144641478|SUPERIORITY|||||||0.011|||||||Wilcoxon rank sum test|||||||0.011
72554850|NCT00520234|144641482|SUPERIORITY_OR_OTHER|||||||0.14||95.0|||||Cochran-Mantel-Haenszel|APACHE II Stratified||||||0.14
72554851|NCT03527485|144641518|EQUIVALENCE|Between-group comparisons of binding potential non displaceable (BPND) in ventral striatum (VS).||||||0.011|||||||ANOVA|||||||0.011
72554852|NCT03527485|144641518|EQUIVALENCE|Between-group comparisons of binding potential non displaceable (BPND) in Prefrontal cortex (PFC).||||||0.044|||||||ANOVA|||||||0.044
72554853|NCT00730691|144641519|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.96|STANDARD_ERROR_OF_MEAN|0.843||0.255|TWO_SIDED|95.0|-2.62|0.69||This treatment arm is not in the pre-specified testing sequence, a nominal p-value is provided.|Mixed model for repeated measurements|P-values are from an MMRM model with week, Baseline score-by-week and treatment-by-week interaction as factors.||P-values were tested at the 5% level of significance (ie, statistical significance if P\<0.05) comparing each of the 3 doses of vortioxetine to placebo.||0.69|-2.62|0.255
72554854|NCT00730691|144641519|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.843||0.719|TWO_SIDED|95.0|-1.96|1.35||Pre-specified sequential statistical testing procedure indicates that when p-value \>0.025, hierarchical testing stops and for subsequent endpoints in the sequence a nominal p-value is provided.|Mixed model for repeated measurements|P-values are from an MMRM model with week, Baseline score-by-week and treatment-by-week interaction as factors.||To control for multiplicity, a pre-specified sequential testing procedure was applied to compare 10 mg and 5 mg vortioxetine to placebo; as soon as an endpoint was non-significant at 0.025, the testing procedure stopped for all subsequent endpoints.||1.35|-1.96|0.719
72554855|NCT00730691|144641519|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.39|STANDARD_ERROR_OF_MEAN|0.848||0.642|TWO_SIDED|95.0|-2.06|1.27||Pre-specified sequential statistical testing procedure indicates that when p-value \>0.025, hierarchical testing stops and for subsequent endpoints in the sequence a nominal p-value is provided.|Mixed model for repeated measurements|P-values are from an MMRM model with week, Baseline score-by-week and treatment-by-week interaction as factors.||To control for multiplicity, a pre-specified sequential testing procedure was applied to compare 10 mg and 5 mg vortioxetine to placebo; as soon as an endpoint was non-significant at 0.025, the testing procedure stopped for all subsequent endpoints.||1.27|-2.06|0.642
72554856|NCT00730691|144641519|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.6|STANDARD_ERROR_OF_MEAN|0.869||0.003|TWO_SIDED|95.0|-4.3|-0.89|||Mixed model for repeated measurements|P-values are from an MMRM model with week, Baseline score-by-week and treatment-by-week interaction as factors.||||-0.89|-4.30|0.003
72554857|NCT00730691|144641520|SUPERIORITY_OR_OTHER||LS Mean Difference|0.11|STANDARD_ERROR_OF_MEAN|0.511||0.83|TWO_SIDED|95.0|-0.89|1.11|||Mixed model for repeated measurements|P-values are from an MMRM model with week, Baseline score-by-week and treatment-by-week interaction as factors.||||1.11|-0.89|0.830
72554858|NCT00730691|144641520|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.24|STANDARD_ERROR_OF_MEAN|0.51||0.643|TWO_SIDED|95.0|-1.24|0.77||Hierarchical testing stopped at the primary endpoint in the testing sequence, a nominal p-value is provided.|Mixed model for repeated measurements|P-values are from an MMRM model with week, Baseline score-by-week and treatment-by-week interaction as factors.||||0.77|-1.24|0.643
72554859|NCT00730691|144641520|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.09|STANDARD_ERROR_OF_MEAN|0.517||0.036|TWO_SIDED|95.0|-2.1|-0.07||Hierarchical testing stopped at the primary endpoint in the testing sequence, a nominal p-value is provided.|Mixed model for repeated measurements|P-values are from an MMRM model with week, Baseline score-by-week and treatment-by-week interaction as factors.||||-0.07|-2.10|0.036
72554860|NCT00730691|144641520|SUPERIORITY_OR_OTHER||LS mean Difference|-1.54|STANDARD_ERROR_OF_MEAN|0.527||0.004|TWO_SIDED|95.0|-2.58|-0.5|||Mixed model for repeated measurements|P-values are from an MMRM model with week, Baseline score-by-week and treatment-by-week interaction as factors.||||-0.50|-2.58|0.004
72554861|NCT00730691|144641521|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.129||0.407|TWO_SIDED|95.0|-0.36|0.15|||Mixed model for repeated measurements|P-values are from an MMRM model with week, Baseline score-by-week and treatment-by-week interaction as factors.||||0.15|-0.36|0.407
72554862|NCT00730691|144641521|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.129||0.533|TWO_SIDED|95.0|-0.33|0.17|||Mixed model for repeated measurements|P-values are from an MMRM model with week, Baseline score-by-week and treatment-by-week interaction as factors.||||0.17|-0.33|0.533
72554863|NCT00730691|144641521|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.13||0.491|TWO_SIDED|95.0|-0.34|0.17|||Mixed model for repeated measurements|P-values are from an MMRM model with week, Baseline score-by-week and treatment-by-week interaction as factors.||||0.17|-0.34|0.491
72554864|NCT00730691|144641521|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.44|STANDARD_ERROR_OF_MEAN|0.133||0.001|TWO_SIDED|95.0|-0.7|-0.17|||Mixed model for repeated measurements|P-values are from an MMRM model with week, Baseline score-by-week and treatment-by-week interaction as factors.||||-0.17|-0.70|0.001
72554865|NCT00730691|144641522|SUPERIORITY_OR_OTHER||LS Mean Difference|0.35|STANDARD_ERROR_OF_MEAN|0.765||0.652|TWO_SIDED|95.0|-1.16|1.85|||Mixed model for repeated measurements|P-values are from an MMRM model with week, Baseline score-by-week and treatment-by-week interaction as factors.||||1.85|-1.16|0.652
72554866|NCT00730691|144641522|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.754||0.511|TWO_SIDED|95.0|-1.98|0.98|||Mixed model for repeated measurements|P-values are from an MMRM model with week, Baseline score-by-week and treatment-by-week interaction as factors.||||0.98|-1.98|0.511
72554867|NCT00730691|144641522|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.94|STANDARD_ERROR_OF_MEAN|0.736||0.204|TWO_SIDED|95.0|-2.38|0.51|||Mixed model for repeated measurements|P-values are from an MMRM model with week, Baseline score-by-week and treatment-by-week interaction as factors.||||0.51|-2.38|0.204
72615202|NCT00407511|144760602|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.6|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001||95.0|-5.1|-4.1|||Mixed Models Analysis||Parameter estimate: Mean Difference (Final Values) = least squares mean.|Week 12: subjects were only included if their visit fell within the computed week (\>= 78 days).||-4.1|-5.1|< 0.0001
72615203|NCT00407511|144760602|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||t-test, 2 sided|||EOT/LOCF: last post-baseline value; mean change from Baseline was the arthmetic mean change and the p-value was from the single-sample t-test.||||< 0.0001
72615204|NCT00407511|144760603|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.8|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001||95.0|-4.2|-3.4|||Mixed Models Analysis||Parameter estimate: Mean Difference (Final Values) = least squares mean.|Week 8: subjects were only included if their visit fell within the computed week (Day 49 to 63).||-3.4|-4.2|< 0.0001
72615205|NCT00407511|144760603|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.1|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001||95.0|-4.5|-3.7|||Mixed Models Analysis||Parameter estimate: Mean Difference (Final Values) = least squares mean.|Week 12: subjects were only included if their visit fell within the computed week (\>= Day 78)||-3.7|-4.5|< 0.0001
72615206|NCT00407511|144760603|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||t-test, 2 sided|||EOT/LOCF: last post-baseline value; mean change from Baseline was the arthmetic mean change and the p-value was from the single-sample t-test.||||< 0.0001
72615207|NCT00407511|144760606|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-18.1|STANDARD_ERROR_OF_MEAN|2.1|<|0.0001||95.0|-22.3|-14.0|||Mixed Models Analysis||Parameter estimate: Mean Difference (Final Values) = least squares mean.|Week 1: LS mean, p-value, and confidence interval are based on a repeated measures mixed effect model with baseline value, center, and week as fixed effects; subject was included as a random effect. Subjects were only included in the Week 1 assessment if their visit fell within Days 4 to 10.||-14.0|-22.3|< 0.0001
72615208|NCT00407511|144760606|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-28.2|STANDARD_ERROR_OF_MEAN|2.1|<|0.0001||95.0|-32.4|-24.0|||Mixed Models Analysis||Parameter estimate: Mean Difference (Final Values) = least squares mean.|Week 2: LS mean, p-value, and confidence interval are based on a repeated measures mixed effect model with baseline value, center, and week as fixed effects; subject was included as a random effect. Subjects were only included in the Week 2 assessment if their visit fell within Days 11 to 17.||-24.0|-32.4|< 0.0001
72615209|NCT00407511|144760606|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-34.3|STANDARD_ERROR_OF_MEAN|2.1|<|0.0001||95.0|-38.5|-30.0|||Mixed Models Analysis||Parameter estimate: Mean Difference (Final Values) = least squares mean.|Week 3: LS mean, p-value, and confidence interval are based on a repeated measures mixed effect model with baseline value, center, and week as fixed effects; subject was included as a random effect. Subjects were only included in the Week 3 assessment if their visit fell within Days 18 to 24.||-30.0|-38.5|< 0.0001
72615210|NCT00407511|144760606|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-40.9|STANDARD_ERROR_OF_MEAN|2.2|<|0.0001||95.0|-45.2|-36.7|||Mixed Models Analysis||Parameter estimate: Mean Difference (Final Values) = least squares mean.|Week 4: LS mean, p-value, and confidence interval are based on a repeated measures mixed effect model with baseline value, center, and week as fixed effects; subject was included as a random effect. Subjects were only included in the Week 4 assessment if their visit fell within days 25 to 35.||-36.7|-45.2|< 0.0001
72615211|NCT00407511|144760606|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-45.8|STANDARD_ERROR_OF_MEAN|2.2|<|0.0001||95.0|-50.2|-41.4|||Mixed Models Analysis||Parameter estimate: Mean Difference (Final Values) = least squares mean.|Week 8: LS mean, p-value, and confidence interval are based on a repeated measures mixed effect model with baseline value, center, and week as fixed effects; subject was included as a random effect. Subjects were only included in the Week 8 assessment if their visit fell within Days 49 to 63.||-41.4|-50.2|< 0.0001
72615212|NCT00407511|144760606|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-48.4|STANDARD_ERROR_OF_MEAN|2.2|<|0.0001||95.0|-52.8|-44.0|||Mixed Models Analysis||Parameter estimate: Mean Difference (Final Values) = least squares mean.|Week 12: LS mean, p-value, and confidence interval are based on a repeated measures mixed effect model with baseline value, center, and week as fixed effects; subject was included as a random effect. Subjects were only included in the Week 12 assessment if their visit fell \>= Day 78.||-44.0|-52.8|< 0.0001
72615213|NCT00407511|144760606|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||t-test, 2 sided|||EOT/LOCF: last post-baseline assessment. Mean change is the arithmetic mean change; p-value is from a single-sample t-test.||||< 0.0001
72615214|NCT00407511|144760607|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-38.7|STANDARD_ERROR_OF_MEAN|2.4|<|0.0001||95.0|-43.4|-33.9|||Mixed Models Analysis||Parameter estimate: Mean Difference (Final Values) = least squares mean.|Week 8: LS mean, p-value, and confidence interval are based on a repeated measures effect model with baseline value, center, and week as fixed effects; subjects were included as a random effect. Subjects were included in the Week 8 assessment only if their visit fell within Days 49 and 63.||-33.9|-43.4|< 0.0001
72615215|NCT00407511|144760607|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-40.7|STANDARD_ERROR_OF_MEAN|2.4|<|0.0001||95.0|-45.5|-35.9|||Mixed Models Analysis||Parameter estimate: Mean Difference (Final Values) = least squares mean.|Week 12: LS mean, p-value, and confidence interval are based on a repeated measures effect model with baseline value, center, and week as fixed effects; subjects were included as a random effect. Subjects were included in the Week 12 assessment only if their visit fell \>=Day 78.||-35.9|-45.5|< 0.0001
72615216|NCT00407511|144760607|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||t-test, 2 sided|||EOT/LOCF: last post-baseline assessment. Mean change= arithmetic mean change; p-value is from a single-sample t-test.||||< 0.0001
72615217|NCT00407511|144760608|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.0|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001||95.0|-1.4|-0.7|||Mixed Models Analysis||Parameter estimate: Mean Difference (Final Values) = least squares mean.|Week 1: LS mean, p-value, and confidence interval are based on repeated measures mixed effect model with baseline value, pooled center, and weeks 1, 4, 8 and 12 as fixed effects; subjects were included as a random effect.||-0.7|-1.4|< 0.0001
72615218|NCT00407511|144760608|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.8|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001||95.0|-2.2|-1.5|||Mixed Models Analysis||Parameter estimate: Mean Difference (Final Values) = least squares mean.|Week 2: LS mean, p-value, and confidence interval are based on repeated measures mixed effect model with baseline value, pooled center, and weeks 1, 4, 8 and 12 as fixed effects; subjects were included as a random effect.||-1.5|-2.2|< 0.0001
72615219|NCT00407511|144760608|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.5|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001||95.0|-2.9|-2.2|||Mixed Models Analysis||Parameter estimate: Mean Difference (Final Values) = least squares mean.|Week 3: LS mean, p-value, and confidence interval are based on repeated measures mixed effect model with baseline value, pooled center, and weeks 1, 4, 8 and 12 as fixed effects; subjects were included as a random effect.||-2.2|-2.9|< 0.0001
72615220|NCT00407511|144760608|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.8|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001||95.0|-3.2|-2.5|||Mixed Models Analysis||Parameter estimate: Mean Difference (Final Values) = least squares mean.|Week 4: LS mean, p-value, and confidence interval are based on repeated measures mixed effect model with baseline value, pooled center, and weeks 1, 4, 8 and 12 as fixed effects; subjects were included as a random effect.||-2.5|-3.2|< 0.0001
72615221|NCT00407511|144760608|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.9|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001||95.0|-3.3|-2.6|||Mixed Models Analysis||Parameter estimate: Mean Difference (Final Values) = least squares mean.|Week 5: LS mean, p-value, and confidence interval are based on repeated measures mixed effect model with baseline value, pooled center, and weeks 1, 4, 8 and 12 as fixed effects; subjects were included as a random effect.||-2.6|-3.3|< 0.0001
72615222|NCT00407511|144760608|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.0|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001||95.0|-3.4|-2.6|||Mixed Models Analysis||Parameter estimate: Mean Difference (Final Values) = least squares mean.|Week 6: LS mean, p-value, and confidence interval are based on repeated measures mixed effect model with baseline value, pooled center, and weeks 1, 4, 8 and 12 as fixed effects; subjects were included as a random effect.||-2.6|-3.4|< 0.0001
72615223|NCT00407511|144760608|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.1|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001||95.0|-3.5|-2.8|||Mixed Models Analysis||Parameter estimate: Mean Difference (Final Values) = least squares mean.|Week 7: LS mean, p-value, and confidence interval are based on repeated measures mixed effect model with baseline value, pooled center, and weeks 1, 4, 8 and 12 as fixed effects; subjects were included as a random effect.||-2.8|-3.5|< 0.0001
72615224|NCT00407511|144760608|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.2|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001||95.0|-3.6|-2.8|||Mixed Models Analysis||Parameter estimate: Mean Difference (Final Values) = least squares mean.|Week 8: LS mean, p-value, and confidence interval are based on repeated measures mixed effect model with baseline value, pooled center, and weeks 1, 4, 8 and 12 as fixed effects; subjects were included as a random effect.||-2.8|-3.6|< 0.0001
72615225|NCT00407511|144760608|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.3|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001||95.0|-3.7|-2.9|||Mixed Models Analysis||Parameter estimate: Mean Difference (Final Values) = least squares mean.|Week 9: LS mean, p-value, and confidence interval are based on repeated measures mixed effect model with baseline value, pooled center, and weeks 1, 4, 8 and 12 as fixed effects; subjects were included as a random effect.||-2.9|-3.7|< 0.0001
72615226|NCT00407511|144760608|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.4|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001||95.0|-3.7|-3.0|||Mixed Models Analysis||Parameter estimate: Mean Difference (Final Values) = least squares mean.|Week 10: LS mean, p-value, and confidence interval are based on repeated measures mixed effect model with baseline value, pooled center, and weeks 1, 4, 8 and 12 as fixed effects; subjects were included as a random effect.||-3.0|-3.7|< 0.0001
72615227|NCT00407511|144760608|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.4|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001||95.0|-3.8|-3.0|||Mixed Models Analysis||Parameter estimate: Mean Difference (Final Values) = least squares mean.|Visit 11: LS mean, p-value, and confidence interval are based on repeated measures mixed effect model with baseline value, pooled center, and weeks 1, 4, 8 and 12 as fixed effects; subjects were included as a random effect.||-3.0|-3.8|< 0.0001
72615228|NCT00407511|144760608|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.4|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001||95.0|-3.7|-3.0|||Mixed Models Analysis||Parameter estimate: Mean Difference (Final Values) = least squares mean.|Week 12: LS mean, p-value, and confidence interval are based on repeated measures mixed effect model with baseline value, pooled center, and weeks 1, 4, 8 and 12 as fixed effects; subjects were included as a random effect.||-3.0|-3.7|< 0.0001
72615229|NCT00407511|144760608|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||t-test, 2 sided|||EOT/LOCF value consists of the mean of the last 7 post-baseline sleep scores; mean change = arithmetic mean change; p-value: from single sample t-test.||||< 0.0001
72615230|NCT03439514|144760611|SUPERIORITY||Median Difference (Net)|4.936||||0.818|TWO_SIDED|95.0|-24.246|34.118||Two-sided p-value|Van Elteren test||The Week 24 change from baseline in 6MWT between PF 07265803 and placebo was estimated using the stratified HL median difference, considering only participants who survived 24 weeks.|||34.118|-24.246|0.818
72615231|NCT03439514|144760617|OTHER||Hazard Ratio (HR)|0.43||||0.2257|TWO_SIDED|95.0|0.13|1.39|||Log Rank|||||1.39|0.13|0.2257
72615232|NCT03439514|144760618|OTHER||Hazard Ratio (HR)|1.19||||0.837|TWO_SIDED|95.0|0.3|4.63|||Log Rank|||||4.63|0.30|0.8370
72615233|NCT04900272|144760624|OTHER|||||||0.785|||||||ANOVA|||||||0.785
72615234|NCT04900272|144760625|OTHER|||||||0.583|||||||ANOVA|||||||0.583
72615235|NCT04900272|144760626|OTHER|||||||0.5015|||||||ANOVA|||||||0.5015
72615236|NCT04900272|144760627|OTHER|||||||0.3536|||||||ANOVA|||||||0.3536
72615237|NCT04900272|144760628|OTHER|||||||0.2688|||||||ANOVA|||||||0.2688
72615238|NCT04900272|144760629|OTHER|||||||0.728|||||||ANOVA|||||||0.728
72615239|NCT04900272|144760630|OTHER|||||||0.473|||||||ANOVA|||||||0.473
72615240|NCT04900272|144760631|OTHER|||||||0.4161|||||||ANOVA|||||||0.4161
72615241|NCT04900272|144760632|OTHER|||||||0.3356|||||||ANOVA|||||||0.3356
72615242|NCT04900272|144760633|OTHER|||||||0.9825|||||||ANOVA|||||||0.9825
72615243|NCT03927157|144760655|SUPERIORITY||Rate Ratio|0.26|||<|0.001|TWO_SIDED|95.0|0.17|0.39|||Negative Binomial Regression|||||0.39|0.17|<0.001
72615244|NCT03927157|144760656|SUPERIORITY||Least Squares Mean Difference|0.24|||<|0.001|TWO_SIDED|95.0|0.16|0.32|||Mixed Models Analysis|||||0.32|0.16|<0.001
72615245|NCT03927157|144760657|SUPERIORITY||Least Squares Means Difference|0.35||||0.001|TWO_SIDED|95.0|0.14|0.55|||Mixed Models Analysis|||||0.55|0.14|0.001
72615246|NCT03927157|144760658|SUPERIORITY||Least Squares Means Difference|-0.31|||<|0.001|TWO_SIDED|95.0|-0.47|-0.15|||Mixed Models Analysis|||||-0.15|-0.47|<0.001
72615247|NCT03927157|144760659|SUPERIORITY||Least Squares Means Difference|-0.16||||0.001|TWO_SIDED|95.0|-0.27|-0.06|||Mixed Models Analysis|||||-0.06|-0.27|0.001
72615248|NCT00315822|144760691|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.94||||0.8|TWO_SIDED|95.0|0.52|1.68|||Cochran-Mantel-Haenszel|||||1.68|0.52|0.80
72615249|NCT00081458|144760692|SUPERIORITY_OR_OTHER_LEGACY|||||||0.007||95.0|||||ANCOVA|||||||0.007
72615250|NCT00081458|144760693|SUPERIORITY_OR_OTHER_LEGACY|||||||0.005||95.0|||||ANCOVA|||An efficacy responder was defined as achieving at least a 20% reduction from Baseline to Week 20 and maintained at Week 24 in weekly actual PN infusion volume.||||0.005
72615251|NCT03384966|144760719|SUPERIORITY||Odds Ratio (OR)|58.9|||<|0.0001|TWO_SIDED|97.5|22.4|154.8||A p-value significance level was set to 0.025, based on an overall Type-I error rate of 0.05 adjusted for multiple comparisons using a Bonferroni approach (two comparisons).|Chi-squared|||"The study aimed at assessing the efficacy of each selatogrel dose versus placebo. The proportion of responders for each of the two doses of selatogrel was compared to placebo.~No imputation was considered for handling missing values."||154.8|22.4|< 0.0001
72615252|NCT03384966|144760719|SUPERIORITY||Odds Ratio (OR)|61.2|||<|0.0001|TWO_SIDED|97.5|23.1|162.3||A p-value significance level was set to 0.025, based on an overall Type-I error rate of 0.05 adjusted for multiple comparisons using a Bonferroni approach (two comparisons).|Chi-squared|||"The study aimed at assessing the efficacy of each selatogrel dose versus placebo. The proportion of responders for each of the two doses of selatogrel was compared to placebo.~No imputation was considered for handling missing values in the main analysis."||162.3|23.1|< 0.0001
72615253|NCT03384966|144760723|OTHER|Logistic regression (Type III analysis)||||||0.1915|||||||Chi-squared|||||||0.1915
72615254|NCT03384966|144760725|OTHER||LS Mean difference with placebo|-27.49|||<|0.0001|TWO_SIDED|95.0|-35.4|-19.6|||Mixed Models Analysis|P-value significance level is set to 0.025, i.e. type I error (0.05) adjusted for multiplicity (2 comparisons) using a Bonferroni approach.||Longitudinal analysis of the treatment effect, from start of treatment to 8 hours after injection.||-19.6|-35.4|<.0001
72615255|NCT03384966|144760725|OTHER||LS Mean difference with placebo|-31.06|||<|0.0001|TWO_SIDED|95.0|-39.0|-23.1|||Mixed Models Analysis|P-value significance level is set to 0.025, i.e. type I error (0.05) adjusted for multiplicity (2 comparisons) using a Bonferroni approach||Longitudinal analysis of the treatment effect, from start of treatment up to 8 hours after injection.||-23.1|-39.0|<.0001
72615256|NCT01119222|144760737|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.28|STANDARD_ERROR_OF_MEAN|2.45|||TWO_SIDED|90.0|-3.82|4.38|||Mixed Models Analysis|||Pre-dose; mixed effect model with random subject effect, fixed period and treatment effects and random subject-by-visit effect as residual. Sample sizing calculated based on results from previous methodology studies performed using the same cold pain test; primary criteria was ability to detect a significant gabapentin effect over placebo.||4.38|-3.82|
72615257|NCT01119222|144760737|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.58|STANDARD_ERROR_OF_MEAN|2.45|||TWO_SIDED|90.0|-3.53|4.68|||Mixed Models Analysis|||Pre-dose; mixed effect model with random subject effect, fixed period and treatment effects and random subject-by-visit effect as residual.||4.68|-3.53|
72615258|NCT01119222|144760737|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.11|STANDARD_ERROR_OF_MEAN|2.45|||TWO_SIDED|90.0|-3.99|4.22|||Mixed Models Analysis|||Pre-dose; mixed effect model with random subject effect, fixed period and treatment effects and random subject-by-visit effect as residual.||4.22|-3.99|
72615259|NCT01119222|144760737|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.14|STANDARD_ERROR_OF_MEAN|1.97|||TWO_SIDED|90.0|-1.15|5.44|||Mixed Models Analysis|||1 hour post-dose: mixed effect model with random subject effect, fixed period and treatment effects and random subject-by-visit effect as residual.||5.44|-1.15|
72615260|NCT01119222|144760737|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.18|STANDARD_ERROR_OF_MEAN|1.97|||TWO_SIDED|90.0|-14.48|-7.89|||Mixed Models Analysis|||1 hour post-dose: mixed effect model with random subject effect, fixed period and treatment effects and random subject-by-visit effect as residual.||-7.89|-14.48|
72615261|NCT01119222|144760737|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.49|STANDARD_ERROR_OF_MEAN|1.96|||TWO_SIDED|90.0|2.2|8.78|||Mixed Models Analysis|||1 hour post-dose: mixed effect model with random subject effect, fixed period and treatment effects and random subject-by-visit effect as residual.||8.78|2.20|
72615262|NCT01119222|144760737|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.73|STANDARD_ERROR_OF_MEAN|2.87|||TWO_SIDED|90.0|-5.53|4.08|||Mixed Models Analysis|||1.5 hours post-dose: mixed effect model with random subject effect, fixed period and treatment effects and random subject-by-visit effect as residual.||4.08|-5.53|
72615263|NCT01119222|144760737|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.93|STANDARD_ERROR_OF_MEAN|2.87|||TWO_SIDED|90.0|-18.74|-9.13|||Mixed Models Analysis|||1.5 hours post-dose: mixed effect model with random subject effect, fixed period and treatment effects and random subject-by-visit effect as residual.||-9.13|-18.74|
72615264|NCT01119222|144760737|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.88|STANDARD_ERROR_OF_MEAN|2.92|||TWO_SIDED|90.0|-2.01|7.78|||Mixed Models Analysis|||1.5 hours post-dose: mixed effect model with random subject effect, fixed period and treatment effects and random subject-by-visit effect as residual.||7.78|-2.01|
72615265|NCT01119222|144760737|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.82|STANDARD_ERROR_OF_MEAN|3.66|||TWO_SIDED|90.0|-5.32|6.96|||Mixed Models Analysis|||2 hours post-dose: mixed effect model with random subject effect, fixed period and treatment effects and random subject-by-visit effect as residual.||6.96|-5.32|
72615266|NCT01119222|144760737|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.12|STANDARD_ERROR_OF_MEAN|3.59|||TWO_SIDED|90.0|-19.14|-7.09|||Mixed Models Analysis|||2 hours post-dose: mixed effect model with random subject effect, fixed period and treatment effects and random subject-by-visit effect as residual.||-7.09|-19.14|
72615267|NCT01119222|144760737|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.58|STANDARD_ERROR_OF_MEAN|3.59|||TWO_SIDED|90.0|-4.45|7.6|||Mixed Models Analysis|||2 hours post-dose: mixed effect model with random subject effect, fixed period and treatment effects and random subject-by-visit effect as residual.||7.60|-4.45|
72615268|NCT01119222|144760737|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.53|STANDARD_ERROR_OF_MEAN|2.9|||TWO_SIDED|90.0|-7.39|2.32||||||4 hours post-dose: mixed effect model with random subject effect, fixed period and treatment effects and random subject-by-visit effect as residual.||2.32|-7.39|
72615269|NCT01119222|144760737|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.59|STANDARD_ERROR_OF_MEAN|2.9|||TWO_SIDED|90.0|-14.44|-4.73|||Mixed Models Analysis|||4 hours post-dose: mixed effect model with random subject effect, fixed period and treatment effects and random subject-by-visit effect as residual.||-4.73|-14.44|
72615270|NCT01119222|144760737|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|2.9|||TWO_SIDED|90.0|-4.85|4.85|||Mixed Models Analysis|||4 hours post-dose: mixed effect model with random subject effect, fixed period and treatment effects and random subject-by-visit effect as residual.||4.85|-4.85|
72615271|NCT01119222|144760737|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.49|STANDARD_ERROR_OF_MEAN|2.22|||TWO_SIDED|90.0|-3.23|4.22|||Mixed Models Analysis|||8 hours post-dose: mixed effect model with random subject effect, fixed period and treatment effects and random subject-by-visit effect as residual.||4.22|-3.23|
72615272|NCT01119222|144760737|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.47|STANDARD_ERROR_OF_MEAN|2.22|||TWO_SIDED|90.0|-11.19|-3.75|||Mixed Models Analysis|||8 hours post-dose: mixed effect model with random subject effect, fixed period and treatment effects and random subject-by-visit effect as residual.||-3.75|-11.19|
72615273|NCT01119222|144760737|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.27|STANDARD_ERROR_OF_MEAN|2.22|||TWO_SIDED|90.0|-3.99|3.45|||Mixed Models Analysis|||8 hours post-dose: mixed effect model with random subject effect, fixed period and treatment effects and random subject-by-visit effect as residual.||3.45|-3.99|
72615274|NCT01119222|144760738|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|2.17|||TWO_SIDED|90.0|-4.24|3.04|||Mixed Models Analysis|||||3.04|-4.24|
72615275|NCT01119222|144760738|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.43|STANDARD_ERROR_OF_MEAN|2.17|||TWO_SIDED|90.0|-13.07|-5.79|||Mixed Models Analysis|||||-5.79|-13.07|
72615276|NCT01119222|144760738|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.84|STANDARD_ERROR_OF_MEAN|2.17|||TWO_SIDED|90.0|-2.8|4.48|||Mixed Models Analysis|||||4.48|-2.80|
72615277|NCT04837521|144760778|SUPERIORITY||γ01|0.25||||0.03|TWO_SIDED||||||t-test, 2 sided||analysis completed using the 1 week follow up data|||||.03
72615278|NCT04837521|144760779|OTHER|The conditions were expected to be similar, and the primary interest of the analysis was changes over time across both groups.|Mean Difference (Final Values)|3.4|||||TWO_SIDED|95.0|2.32|4.49||To estimate the mean improvement in PSFS across the entire sample, we calculated a posterior predictive distribution of within-person change scores between time fixed equal to 0 and equal to -1.|Bayesian framework|||PSFS scores were analyzed using mixed-effects linear growth models with time, treatment condition, and their interaction as predictors. Random effects modeled variation in intercepts, slopes over time, and their covariance. Time was specified as a continuous variable, centered on the final observation date. The SG group served as the reference level for the treatment factor. Models were estimated in a Bayesian framework using default priors in the brms package.||4.49|2.32|
72615279|NCT00221104|144760797|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.97||||0.8234|TWO_SIDED|95.0|0.73|1.29|||Stratified log-rank test|log-rank test adjusted for the stratification factors at randomization: stroke subtype, high blood pressure, and diabetes mellitus|the adjusted hazard ratio (HR) and the 95% confidence interval (CI) were calculated by the Cox proportional hazard model with for the stratification factors at randomization: stroke subtype, high blood pressure, and diabetes mellitus|the stratification factors at randomization: stroke subtype (atherothrombotic infarction vs. others), high blood pressure (≥150/90 mmHg vs. not), and diabetes mellitus (absence vs. presence)||1.29|0.73|0.8234
72615280|NCT00221104|144760798|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.33||||0.0047|TWO_SIDED|95.0|0.15|0.74|||Stratified log-rank test|log-rank test adjusted for the stratification factors at randomization: stroke subtype, high blood pressure, and diabetes mellitus|The adjusted hazard ratio (HR) and the 95% confidence interval (CI) were calculated by the Cox proportional hazard model with for the stratification factors at randomization: stroke subtype, high blood pressure, and diabetes mellitus|the stratification factors at randomization: stroke subtype (atherothrombotic infarction vs. others), high blood pressure (≥150/90 mmHg vs. not), and diabetes mellitus (absence vs. presence)||0.74|0.15|0.0047
72615281|NCT00221104|144760799|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.25||||0.3075|TWO_SIDED|95.0|0.81|1.91|||Stratified log-rank test|log-rank test adjusted for the stratification factors at randomization: stroke subtype, high blood pressure, and diabetes mellitus|The adjusted hazard ratio (HR) and the 95% confidence interval (CI) were calculated by the Cox proportional hazard model with for the stratification factors at randomization: stroke subtype, high blood pressure, and diabetes mellitus|the stratification factors at randomization: stroke subtype (atherothrombotic infarction vs. others), high blood pressure (≥150/90 mmHg vs. not), and diabetes mellitus (absence vs. presence)||1.91|0.81|0.3075
72615282|NCT00221104|144760800|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.36||||0.1986|TWO_SIDED|95.0|0.61|9.14|||Stratified log-rank test|log-rank test adjusted for the stratification factors at randomization: stroke subtype, high blood pressure, and diabetes mellitus|The adjusted hazard ratio (HR) and the 95% confidence interval (CI) were calculated by the Cox proportional hazard model with for the stratification factors at randomization: stroke subtype, high blood pressure, and diabetes mellitus|the stratification factors at randomization: stroke subtype (atherothrombotic infarction vs. others), high blood pressure (≥150/90 mmHg vs. not), and diabetes mellitus (absence vs. presence)||9.14|0.61|0.1986
72615283|NCT00221104|144760801|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.0||||0.9953|TWO_SIDED|95.0|0.45|2.22|||Stratified log-rank test|log-rank test adjusted for the stratification factors at randomization: stroke subtype, high blood pressure, and diabetes mellitus|The adjusted hazard ratio (HR) and the 95% confidence interval (CI) were calculated by the Cox proportional hazard model with for the stratification factors at randomization: stroke subtype, high blood pressure, and diabetes mellitus|the stratification factors at randomization: stroke subtype (atherothrombotic infarction vs. others), high blood pressure (≥150/90 mmHg vs. not), and diabetes mellitus (absence vs. presence)||2.22|0.45|0.9953
72615284|NCT02989389|144760808|SUPERIORITY||Mean Difference (Final Values)|-11.57||||0.215|TWO_SIDED|90.0|-29.52|10.96|||Mixed Models Analysis|||Aβ 1-40||10.96|-29.52|0.215
72615285|NCT02989389|144760808|SUPERIORITY||Mean Difference (Final Values)|-60.53|||<|0.001|TWO_SIDED|90.0|-69.79|-48.43|||Mixed Models Analysis|||Aβ 1-40||-48.43|-69.79|<0.001
72615286|NCT02989389|144760808|SUPERIORITY||Mean Difference (Final Values)|-87.07|||<|0.001|TWO_SIDED|90.0|-90.21|-82.92|||Mixed Models Analysis|||Aβ 1-40||-82.92|-90.21|<0.001
72615287|NCT02989389|144760808|SUPERIORITY||Mean Difference (Final Values)|-19.6||||0.015|TWO_SIDED|90.0|-33.69|-2.51|||Mixed Models Analysis|||Aβ 1-42||-2.51|-33.69|0.015
72615288|NCT02989389|144760808|SUPERIORITY||Mean Difference (Final Values)|-65.41|||<|0.001|TWO_SIDED|90.0|-72.23|-56.92|||Mixed Models Analysis|||Aβ 1-42||-56.92|-72.23|<0.001
72615289|NCT02989389|144760808|SUPERIORITY||Mean Difference (Final Values)|-84.56|||<|0.001|TWO_SIDED|90.0|-88.97|-78.38|||Mixed Models Analysis|||Aβ 1-42||-78.38|-88.97|<0.001
72615290|NCT04470427|144760809|OTHER||VE|93.2|||<|0.0001|TWO_SIDED|95.0|91.0|94.8|||Vaccine Efficacy (VE)|VE (percent) is demonstrated if the lower limit of the 2-sided confidence interval for the VE is above 30%.|VE (percent) was estimated with 1 - Hazard Ratio (mRNA-1273 vs. placebo) from stratified Cox proportional hazard model.|"Vaccine efficacy was defined as the percent reduction in the hazard of the primary endpoint (mRNA-1273 vs. placebo).~Null hypothesis of Vaccine Efficacy ≤30%, 95% CI."||94.8|91.0|<.0001
72615291|NCT04470427|144760815|OTHER||VE|98.2|||||TWO_SIDED|95.0|92.8|99.6|||VE||VE (percent) was estimated with 1 - Hazard Ratio (mRNA-1273 vs. placebo) from stratified Cox proportional hazard model.|||99.6|92.8|
72615292|NCT04470427|144760816|OTHER||VE|82.0|||||TWO_SIDED|95.0|79.5|84.2|||||VE (percent) was estimated with 1 - Hazard Ratio (mRNA-1273 vs. placebo) from stratified Cox proportional hazard model|||84.2|79.5|
72615293|NCT04470427|144760817|OTHER|VE|VE|93.4|||||TWO_SIDED|95.0|91.4|94.9|||||VE (percent) was estimated with 1 - Hazard Ratio (mRNA-1273 vs. placebo) from stratified Cox proportional hazard model.|||94.9|91.4|
72615294|NCT04470427|144760819|OTHER||VE|93.3|||||TWO_SIDED|95.0|91.1|94.9|||||VE (percent) was estimated with 1 - Hazard Ratio (mRNA-1273 vs. placebo) from stratified Cox proportional hazard model.|||94.9|91.1|
72615295|NCT04470427|144760820|OTHER||VE|82.0|||||TWO_SIDED|95.0|79.5|84.3|||||VE (percent) was estimated with 1 - Hazard Ratio (mRNA-1273 vs. placebo) from stratified Cox proportional hazard model.|||84.3|79.5|
72615296|NCT04470427|144760821|OTHER||VE|63.0|||||TWO_SIDED|95.0|56.6|68.5|||||VE (percent) was estimated with 1 - Hazard Ratio (mRNA-1273 vs. placebo) from stratified Cox proportional hazard model.|||68.5|56.6|
72615297|NCT04470427|144760827|NON_INFERIORITY|Non-inferiority of a booster as compared with mRNA-1273 after second dose based on Ratio of GMC is demonstrated if lower bound of 95% CI of Ratio of GMC ≥ 0.67.|Ratio of GMC|6.996|||||TWO_SIDED|95.0|6.509|7.52||||||Ratio of GMC 28 days following the booster dose (BD-Day 29) compared with 28 days following second dose (Part A-Day 57).||7.520|6.509|
72615298|NCT04470427|144760828|NON_INFERIORITY|Non-inferiority of a booster as compared with mRNA-1273 after second dose based on SRR difference is demonstrated if lower bound of 95% CI of SRR difference \> -10%.|Difference in Seroresponse|0.9|||||TWO_SIDED|95.0|0.1|1.8|||||95% CI were calculated using adjusted Wald method for the paired binary data.|Seroresponse 28 days following the booster dose (BD-Day 29) compared with 28 days following second dose (Part A-Day 57)||1.8|0.1|
72615299|NCT02232698|144760835|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.24|STANDARD_ERROR_OF_MEAN|0.239|<|0.0001|TWO_SIDED||||||ANCOVA|||||||<0.0001
72615300|NCT02232698|144760836|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.059||0.9556|TWO_SIDED||||||ANCOVA|||||||0.9556
72615301|NCT02232698|144760837|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.82|STANDARD_ERROR_OF_MEAN|0.175|<|0.0001|TWO_SIDED|||||Statistical analysis of time spent \<55 mg/dL|ANCOVA|||||||<0.0001
72615302|NCT02232698|144760837|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.46|STANDARD_ERROR_OF_MEAN|0.122||0.0003|TWO_SIDED|||||Statistical analysis of time spent \<40 mg/dL|ANCOVA|||||||0.0003
72615303|NCT02232698|144760838|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.45|STANDARD_ERROR_OF_MEAN|0.089|<|0.0001|TWO_SIDED||||||ANCOVA|||Statistical analysis of frequency of episodes \<70 mg/dL||||<0.0001
72615304|NCT02232698|144760838|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.38|STANDARD_ERROR_OF_MEAN|0.074|<|0.0001|TWO_SIDED||||||ANCOVA|||Statistical analysis of frequency of episodes \<55 mg/dL||||<0.0001
72615305|NCT02232698|144760838|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.22|STANDARD_ERROR_OF_MEAN|0.05|<|0.0001|TWO_SIDED||||||ANCOVA|||Statistical analysis of frequency of episodes \<40 mg/dL||||<0.0001
72615306|NCT02232698|144760839|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.19|STANDARD_ERROR_OF_MEAN|0.329||0.5623|TWO_SIDED||||||ANCOVA|||Statistical analysis of time spent \>180 mg/dL||||0.5623
72615307|NCT02232698|144760839|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.37|STANDARD_ERROR_OF_MEAN|0.163||0.0247|TWO_SIDED||||||ANCOVA|||Statistical analysis for time spent \>240 mg/dL||||0.0247
72615308|NCT02232698|144760840|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.0|STANDARD_ERROR_OF_MEAN|0.3||0.0006|TWO_SIDED||||||ANCOVA|||||||0.0006
72615309|NCT02232698|144760843|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0|STANDARD_ERROR_OF_MEAN|0.22|<|0.0001|TWO_SIDED||||||ANCOVA|||Statistical analysis of perceived frequency of hyperglycaemia||||<0.0001
72615310|NCT02232698|144760843|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.22||0.0713|TWO_SIDED||||||ANCOVA|||Statistical analysis of perceived frequency of hypoglycaemia||||0.0713
72615311|NCT02232698|144760843|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.1|STANDARD_ERROR_OF_MEAN|0.84|<|0.0001|TWO_SIDED||||||ANCOVA|||Statistical analysis of total treatment satisfaction score||||<0.0001
72615312|NCT02337946|144760850|SUPERIORITY||Difference of PFS rate between groups|0.9|||||TWO_SIDED|95.0|-17.2|19.0|||||||Agresti-Caffo method was used for estimation of 95% CI.|19.0|-17.2|
72615313|NCT02337946|144760851|SUPERIORITY||Adjusted Hazard Ratio (HR)|0.93||||0.7349|TWO_SIDED|95.0|0.6|1.43|||Regression, Multivariable Cox|The Cox regression model was adjusted by stratification factors except for study sites.||||1.43|0.60|0.7349
72615314|NCT02337946|144760852|SUPERIORITY||Adjusted Hazard Ratio (HR)|1.41||||0.3485|TWO_SIDED|95.0|0.69|2.88|||Regression, Multivariable Cox|The Cox regression model was adjusted by stratification factors except for study sites.||||2.88|0.69|0.3485
72615315|NCT02337946|144760854|SUPERIORITY||Multivariable Hazard Ratio (HR)|0.9||||0.5901|TWO_SIDED|95.0|0.6|1.33|||Regression, Multivariable Cox|The Cox regression model was adjusted by stratification factors except for study sites.||||1.33|0.60|0.5901
72615316|NCT01251861|144760863|SUPERIORITY|||||||0.28||||||one-sided|Fisher Exact|||||||0.28
72615317|NCT01251861|144760872|OTHER|The association between PSA response (responder vs non-responder) and Gleason score (\<7, 7 vs. \>7) was evaluated by logistic regression with adjustment for treatment assignment.||||||0.5||||||p-value based on logistic regression with adjustment for treatment assignment|Regression, Logistic|||The association between PSA response (responder vs non-responder) and Gleason score (\<7, 7 vs. \>7) was evaluated by logistic regression with adjustment for treatment assignment.||||0.50
72615318|NCT01251861|144760873|OTHER|The association between PSA response (responder vs non-responder) and prior hormonal therapy (yes vs. no) was evaluated by logistic regression with adjustment for treatment assignment.||||||0.28||||||p-value based on logistic regression with adjustment for treatment assignment|Regression, Logistic|||The association between PSA response (responder vs non-responder) and prior hormonal therapy (yes vs. no) was evaluated by logistic regression with adjustment for treatment assignment.||||0.28
72615319|NCT03720847|144760875|SUPERIORITY||Mean Difference (Final Values)|0.26||||0.012|TWO_SIDED||||||t-test, 2 sided|paired sample t-test comparing perimenstrual change in the placebo vs. active conditions within a given participant.|Positive estimated value indicates greater perimenstrual increase in symptoms in the placebo condition relative to the active condition.|||||.012
72615320|NCT03720847|144760876|SUPERIORITY||Mean Difference (Final Values)|0.21||||0.03|TWO_SIDED||||||t-test, 2 sided|paired sample t-test comparing perimenstrual change in the placebo vs. active conditions within a given participant.|Positive estimated value indicates a greater perimenstrual increase in the outcome in the placebo condition relative to the active condition.|paired sample t-test comparing perimenstrual change in the placebo vs. active conditions within a given participant.||||.030
72615321|NCT03720847|144760877|SUPERIORITY||Mean Difference (Final Values)|3.16||||0.013|TWO_SIDED||||||t-test, 2 sided||Positive estimated value indicates greater perimenstrual increase in symptoms in the placebo condition relative to the active condition.|paired sample t-test comparing perimenstrual change in the placebo vs. active conditions within a given participant.||||.013
72615322|NCT03720847|144760878|SUPERIORITY||Mean Difference (Final Values)|3.65||||0.018|TWO_SIDED||||||t-test, 2 sided||Positive estimated value indicates greater perimenstrual change in the placebo condition relative to the active condition.|paired sample t-test comparing perimenstrual change in the placebo vs. active conditions within a given participant.||||.018
72615323|NCT03720847|144760879|SUPERIORITY||Mean Difference (Final Values)|1.04||||0.073|TWO_SIDED||||||t-test, 2 sided||Positive estimated value indicates greater perimenstrual increase in symptoms in the placebo condition relative to the active condition.|paired sample t-test comparing perimenstrual change in the placebo vs. active conditions within a given participant.||||.073
72615324|NCT03720847|144760880|SUPERIORITY||Mean Difference (Final Values)|-1.16||||0.25|TWO_SIDED||||||t-test, 2 sided|||paired sample t-test comparing perimenstrual change in the placebo vs. active conditions within a given participant.||||.25
72615325|NCT03720847|144760881|SUPERIORITY||Mean Difference (Final Values)|-1.32||||0.23|TWO_SIDED||||||t-test, 2 sided|||paired sample t-test comparing perimenstrual change in the placebo vs. active conditions within a given participant.||||.23
72615326|NCT02734667|144760902|SUPERIORITY||t statistic from GLM/regression|-0.47||||0.64|TWO_SIDED|||||Generalized linear models were used to compare outcomes between the CGM and control groups at 6 months while adjusting for participant gender, age, annual household income, days since diagnosis, and baseline A1c.|Regression, Linear|||||||0.64
72615327|NCT02734667|144760903|SUPERIORITY||t-statistic from GLM/regression results|-2.6||||0.013|TWO_SIDED|||||Generalized linear models were used to compare outcomes between the CGM and control groups at 6 months while adjusting for participant gender, age, annual household income, days since diagnosis, and baseline A1c.|Regression, Linear|||||||0.013
72615328|NCT02734667|144760904|SUPERIORITY||t-statistic from GLM/regression results|3.12||||0.003|TWO_SIDED|||||Generalized linear models were used to compare outcomes between the CGM and control groups at 6 months while adjusting for participant gender, age, annual household income, days since diagnosis, and baseline A1c.|Regression, Linear|||||||0.003
72615329|NCT00195429|144760932|SUPERIORITY_OR_OTHER_LEGACY|||||||1||95.0|||||Fisher Exact|||||||1.0
72615330|NCT00195429|144760933|SUPERIORITY_OR_OTHER_LEGACY|||||||0.361||95.0|||||Student's t-test|||||||0.361
72615331|NCT04925934|144760958|SUPERIORITY||Rate Difference|2.8|||=|0.7474|TWO_SIDED|90.0|-11.4|17.0|||Regression, Logistic|||Adjusted response rate, rate difference and p-value are from logistic regression analysis with treatment and randomization stratification factors in the model.||17.0|-11.4|=0.7474
72615332|NCT04925934|144760958|SUPERIORITY||Rate Difference|-0.1|||=|0.9942|TWO_SIDED|90.0|-14.2|14.1|||Regression, Logistic|||Adjusted response rate, rate difference and p-value are from logistic regression analysis with treatment and randomization stratification factors in the model.||14.1|-14.2|=0.9942
72615333|NCT04925934|144760959|SUPERIORITY||Rate Difference|37.2|||=|0.1626|TWO_SIDED|90.0|-0.3|74.7|||Regression, Logistic|||Adjusted response rate, rate difference and p-value are from logistic regression analysis with treatment, randomization stratification factors and Baseline CLASI-A score in the model.||74.7|-0.3|=0.1626
72615334|NCT04925934|144760959|SUPERIORITY||Rate Difference|24.1|||=|0.2873|TWO_SIDED|90.0|-7.5|55.8|||Regression, Logistic|||Adjusted response rate, rate difference and p-value are from logistic regression analysis with treatment, randomization stratification factors and Baseline CLASI-A score in the model.||55.8|-7.5|=0.2873
72615335|NCT04925934|144760960|SUPERIORITY||Rate Difference|8.6|||=|0.322|TWO_SIDED|90.0|-5.6|22.7|||Regression, Logistic|||Adjusted response rate, rate difference and p-value are from logistic regression analysis with treatment and randomization stratification factors in the model.||22.7|-5.6|=0.3220
72615336|NCT04925934|144760960|SUPERIORITY||Rate Difference|2.9|||=|0.7364|TWO_SIDED|90.0|-11.2|17.0|||Regression, Logistic|||Adjusted response rate, rate difference and p-value are from logistic regression analysis with treatment and randomization stratification factors in the model.||17.0|-11.2|=0.7364
72615337|NCT04925934|144760961|SUPERIORITY||Rate Difference|11.7|||=|0.2805|TWO_SIDED|90.0|-6.1|29.4|||Regression, Logistic|||Adjusted response rate, rate difference and p-value are from logistic regression analysis with treatment, stratification factors (SLEDAI-2K only) and Baseline OGC dose included in the model.||29.4|-6.1|=0.2805
72615338|NCT04925934|144760961|SUPERIORITY||Rate Difference|9.4|||=|0.3926|TWO_SIDED|90.0|-8.6|27.3|||Regression, Logistic|||Adjusted response rate, rate difference and p-value are from logistic regression analysis with treatment, stratification factors (SLEDAI-2K only) and Baseline OGC dose included in the model.||27.3|-8.6|=0.3926
72615339|NCT04925934|144760962|SUPERIORITY||Rate Difference|16.5|||=|0.037|TWO_SIDED|90.0|4.0|29.0|||Regression, Logistic|||Adjusted response rate, rate difference and p-value are from logistic regression analysis with treatment and randomization stratification factors in the model.||29.0|4.0|=0.0370
72622168|NCT03382873|144774350|SUPERIORITY|||||||0.9476|||||||ANOVA|Intervention sequence and sex used as independent predictors in the model.||Comparison of the GLB/GLB intervention sequence to the GLB+/GLB+ intervention sequence (the primary comparison of interest).||||0.9476
72615340|NCT04925934|144760962|SUPERIORITY||Rate Difference|4.9|||=|0.4939|TWO_SIDED|90.0|-6.7|16.4|||Regression, Logistic|||Adjusted response rate, rate difference and p-value are from logistic regression analysis with treatment and randomization stratification factors in the model.||16.4|-6.7|=0.4939
72615341|NCT03158688|144760968|SUPERIORITY||Stratified Cox model hazard ratio|0.63||||0.0014|TWO_SIDED|95.0|0.464|0.854||alpha level of 0.025|Log Rank||KdD/Kd|Stratification factors used in the Log-rank p-value (1-sided) and the Cox model hazard ratio (KdD/Kd) were as assessed at randomization: International Staging System stage at screening (Stage 1 or 2 vs Stage 3); prior proteasome inhibitor exposure (yes vs no); number of prior lines of therapy (1 vs \>= 2).||0.854|0.464|0.0014
72615342|NCT03158688|144760969|SUPERIORITY||Odds Ratio (OR)|1.925||||0.004|TWO_SIDED|95.0|1.184|3.129|||Cochran-Mantel-Haenszel||KdD/Kd|"Odds ratios and corresponding 95% CIs were estimated using the stratified Mantel-Haenszel method.~P-values were calculated using the stratified Cochran-Mantel-Haenszel Chi-Square test."||3.129|1.184|0.0040
72615343|NCT03158688|144760970|SUPERIORITY||Odds Ratio (OR)|7.819|||||TWO_SIDED|95.0|2.364|25.858|||||KdD/Kd|Odds ratios and corresponding 95% CIs were estimated using the stratified Mantel-Haenszel method.||25.858|2.364|
72615344|NCT03158688|144760971|SUPERIORITY||Cox Proportional Hazard|0.784||||0.0417|TWO_SIDED|95.0|0.595|1.033|||Log Rank||KdD/Kd|"Hazard ratio and corresponding 95% CIs were estimated using the stratified Cox proportional hazards models.~1-sided p-value from the log-rank test controlling for the randomization stratification factors."||1.033|0.595|0.0417
72615345|NCT03158688|144760980|SUPERIORITY||Odds Ratio (OR)|4.403|||||TWO_SIDED|95.0|2.007|9.656|||||KdD/Kd|Odds ratios and corresponding 95% CIs were estimated by a stratified analysis using the Mantel-Haenszel method.||9.656|2.007|
72615346|NCT03158688|144760981|SUPERIORITY||Mean Difference (Final Values)|-0.08|STANDARD_ERROR_OF_MEAN|1.24||0.948|TWO_SIDED|95.0|-2.52|2.35|||linear mixed effects model||The overall treatment difference (KdD - Kd)|Analysis was performed based on a linear mixed effects model. The model included fixed effects of treatment (all baseline responses were modeled with a dummy treatment), baseline QLQ-C30 GHS/QoL score, randomization stratification factors (ISS stage at screening (Stage 1 or 2 vs Stage 3), prior proteasome inhibitor exposure (yes vs no), number of prior lines of therapy (1 vs ≥ 2)), interaction between treatment and time, and random effects of participant intercept and random slope of time.||2.35|-2.52|0.9480
72615347|NCT03188185|144761004|SUPERIORITY|Hypothesis tests were two-sided with an alpha of 0.05 .|Least Squares Mean Difference|-1.5|STANDARD_ERROR_OF_MEAN|0.99||0.128|TWO_SIDED|95.0|-3.5|0.4||ALK 5461 was compared to placebo using stage-specific MMRM for MADRS-10 Change from Baseline.Model-derived estimates were combined using equal weights|Mixed Models Analysis|||Analysis was conducted for each stage separately, and overall efficacy was based on combined stage analysis where stage-specific estimates were combined using pre-specified equal weights. Within each stage ALKS 5461 2mg/2mg was compared to placebo (i.e., ALKS 5461 2mg/2mg S1 vs Placebo S1; and ALKS 5461 2mg/2mg S2 vs Placebo S2).||0.4|-3.5|0.128
72615348|NCT04822194|144761031|SUPERIORITY|||||||0.053|||||||Mixed Models Analysis|Ran linear mixed model, p-value above reflects group by session interaction.||Null hypothesis: no difference between groups. Power analyses using an approximate effect size (d=.70) previously reported for within and between-subjects behavioral analyses of longitudinal reappraisal training data indicate over 95% power (α=.05) to detect within-group effects and 90% power (α=.05) to detect between-group effects require 36 per group.||||0.053
72615349|NCT04822194|144761032|SUPERIORITY|||||||0.741|||||||Mixed Models Analysis|Ran linear mixed models on natural log of RMSSD, p-value above reflects group by session interaction.||Null hypothesis: no difference between groups. Power analyses using an approximate effect size (d=.70) previously obtained for within and between-subjects analyses of respiratory sinus arrhythmia data indicate over 95% power (α=.05) to detect within-group effects and 90% power (α=.05) to detect between-group effects should be achieved with 36 per group.||||0.741
72615350|NCT04822194|144761033|SUPERIORITY|||||||0.021|||||||Mixed Models Analysis|Ran linear mixed model, p-value above reflects a group by session interaction.||Null hypothesis: no difference between groups. Power analyses using a within-subject fMRI effect size estimate for right amygdala affective reactivity from a meta-analysis of Human Connectome Project data of approx. d=.70, applying to between-subjects effects as well, indicate over 95% power (α=.05) to detect within-group effects and 90% power (α=0.05) to detect between-group effects should be achieved with 36 participants per group.||||0.021
72615351|NCT04822194|144761034|SUPERIORITY|||||||0.724|||||||Mixed Models Analysis|We ran linear mixed models, p-value reflects a group by session interaction for the UGRS composite scores.||Null hypothesis: no difference between groups. Power analyses of an effect size (d=.70) previously reported for within and between-subjects analyses of questionnaire outcomes (i.e., depressive symptoms, grief rumination, perceived stress, reappraisal usage) indicate over 95% power (α=.05) to detect within-group effects and 90% power (α=0.05) for between-group effects should be achieved with 36 per group.||||0.724
72615352|NCT04822194|144761034|SUPERIORITY|||||||0.835|||||||Mixed Models Analysis|Ran linear mixed model on counterfactuals adjusted for covariates, p-value above reflects group by session interaction.||Null hypothesis: no difference between groups||||0.835
72615353|NCT04822194|144761034|SUPERIORITY|||||||0.09|||||||Mixed Models Analysis|Ran linear mixed model on injustice adjusted for covariates, p-value above reflects group by session interaction.||Null hypothesis: no difference between groups.||||0.090
72615354|NCT04822194|144761034|SUPERIORITY|||||||0.983|||||||Mixed Models Analysis|Ran linear mixed model on meaning adjusted for covariates, p-value above reflects group by session interaction.||Null hypothesis: no difference between groups||||0.983
72615355|NCT04822194|144761034|SUPERIORITY|||||||0.76|||||||Mixed Models Analysis|Ran linear mixed model on reaction adjusted for covariates, p-value above reflects group by session interaction.||Null hypothesis: no difference between groups||||0.760
72615356|NCT04822194|144761034|SUPERIORITY|||||||0.402|||||||Mixed Models Analysis|Ran linear mixed model on relations adjusted for covariates, p-value above reflects group by session interaction.||Null hypothesis: no difference between groups.||||0.402
72615357|NCT04822194|144761035|SUPERIORITY|||||||0.092|||||||Mixed Models Analysis|We ran a linear mixed model, p-value reflects group by session interaction||Null hypothesis: no difference between groups||||0.092
72615358|NCT04822194|144761036|SUPERIORITY|||||||0.585|||||||Mixed Models Analysis|Ran a linear mixed model, p-value reflects group by session interaction||Null hypothesis: no difference between groups||||0.585
72615359|NCT04822194|144761037|SUPERIORITY|||||||0.7|||||||Mixed Models Analysis|Ran linear mixed model, p-value reflects group by session interaction||Null hypothesis: no difference between groups||||0.70
72615360|NCT04822194|144761038|SUPERIORITY|||||||0.696|||||||Mixed Models Analysis|Ran linear mixed model on emotional problems adjusted for covariates, p-value above reflects group by session interaction||Null hypothesis: no difference between groups.||||0.696
72615361|NCT04822194|144761038|SUPERIORITY|||||||0.452|||||||Mixed Models Analysis|Ran linear mixed model on emotional well-being adjusted for covariates, p-value reflects group by session interaction||Null hypothesis: no difference between groups||||0.452
72615362|NCT04822194|144761038|SUPERIORITY|||||||0.65|||||||Mixed Models Analysis|Ran a linear mixed model on energy adjusted for covariates, p-value above reflects group by session interaction.||Null hypothesis: no difference between groups||||0.650
72615363|NCT04822194|144761038|SUPERIORITY|||||||0.224|||||||Mixed Models Analysis|Ran linear mixed model on general health perceptions adjusted for covariates, p-value above reflects group by session interaction.||Null hypothesis: no difference between groups||||0.224
72615364|NCT04822194|144761038|SUPERIORITY|||||||0.256|||||||Mixed Models Analysis|Ran linear mixed model on pain adjusted for covariates, p-value above reflects group by session interaction.||Null hypothesis: no difference in groups||||0.256
72615365|NCT04822194|144761038|SUPERIORITY|||||||0.984|||||||Mixed Models Analysis|Ran linear mixed model on physical function adjusted for covariates, p-value above reflects group by session interaction.||Null hypothesis: no difference between groups||||0.984
72615366|NCT04822194|144761038|SUPERIORITY|||||||0.363|||||||Mixed Models Analysis|Ran linear mixed model on physical health adjusted for covariates, p-value above reflects group by session interaction.||Null hypothesis: no difference between groups||||0.363
72615367|NCT04822194|144761038|SUPERIORITY|||||||0.045|||||||Mixed Models Analysis|Ran linear mixed model on social functioning adjusted for covariates, p-value above reflects group by session interaction.||Null hypothesis: no difference between groups||||0.045
72615368|NCT04822194|144761039|SUPERIORITY|||||||0.422|||||||ANCOVA|Ran a repeated measures ANCOVA of logged IL-6 serum, p-value above reflects time by ER group interaction effect.||Null hypothesis: no difference between groups||||0.422
72615369|NCT04822194|144761039|SUPERIORITY|||||||0.438|||||||ANCOVA|Ran a repeated measures ANCOVA of TNFα, p-value above reflects time by ER group interaction effect.||Null hypothesis: no difference between groups||||0.438
72615370|NCT00294398|144761049|SUPERIORITY_OR_OTHER|||||||0.87|TWO_SIDED||||||t-test, 2 sided|||||||0.87
72615371|NCT00248547|144761051|SUPERIORITY_OR_OTHER|||||||0.041||95.0|||||Wilcoxon Rank Sum Test|||||||0.041
72615372|NCT02965833|144761055|SUPERIORITY||||||=|0.0073|||||||Mixed Models Analysis|||||||=0.0073
72615373|NCT05494632|144761073|SUPERIORITY||Median Difference (Net)|1.0|||<|0.001|TWO_SIDED|||||the threshold for statistical significance was \<=0.05|Wilcoxon (Mann-Whitney)|||||||<0.001
72615374|NCT01590875|144761160|EQUIVALENCE|Kappa statistics on per pulmonary vein basis were used to determine the probability of recovery, transient recovery or no recovery with second adenosine dose compared with probability of same response after first adenosine dose|||||<|0.01|||||||no relevant statistical analysis|||Kappa statistics on per pulmonary vein basis were used to determine the probability of recovery, transient recovery or no recovery with second adenosine dose compared with probability of same response after first adenosine dose||||<0.01
72615375|NCT01590875|144761161|EQUIVALENCE|Kappa statistics on per pulmonary vein basis were used to determine the probability of recovery, transient recovery or no recovery with second adenosine dose compared with probability of same response after first adenosine dose|||||<|0.01|||||||kappa statistic|||Kappa statistics on per pulmonary vein basis were used to determine the probability of recovery, transient recovery or no recovery with second adenosine dose compared with probability of same response after first adenosine dose||||< 0.01
72615376|NCT01214720|144761165|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.73||||0.0002|TWO_SIDED|95.0|0.61|0.86|||Log Rank|||||0.86|0.61|0.0002
72615377|NCT01214720|144761166|SUPERIORITY_OR_OTHER||Difference in Response Rates|3.62||||0.3621|TWO_SIDED|95.0|-4.3|11.6|||Chi-squared|Approximate 95% confidence interval (CI) for difference of two rates using Hauck-Anderson method.||||11.6|-4.3|0.3621
72615378|NCT01214720|144761167|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.89||||0.2087||95.0|0.74|1.07|||Log Rank|||||1.07|0.74|0.2087
72615379|NCT02347787|144761169|SUPERIORITY|||||||0.3|||||||Regression, Linear|||Determination of targeted sample size was based on detecting a between-arm difference in mean change in SF-12 Physical Component Summary of 3 points, which is the minimal clinically significant difference for this instrument. To achieve at least 80% power with a type I error rate of 5%, we required 444 total participants. To account for 25% attrition, we aimed to accrue 592 participants.||||0.30
72504976|NCT01462292|144541159|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.356||||0.723|TWO_SIDED|95.0|-10.936|15.648||No adjustment for multiplicity was made, so p-values should not be used to make conclusions with regards to statistical significance|ANCOVA|Model includes terms for Treatment, Centre Grouping and Baseline Muscle Strength Total Score||Treatment difference: Placebo Vs GSK2402968 3 mg||15.648|-10.936|0.723
72615380|NCT02347787|144761170|SUPERIORITY||Risk Difference (RD)|-0.2||||0.21|TWO_SIDED|95.0|-1.3|0.9|||Regression, Linear|||||0.9|-1.3|0.21
72615381|NCT02347787|144761171|SUPERIORITY||Risk Difference (RD)|-0.2||||0.21|TWO_SIDED|95.0|-0.7|0.4|||Regression, Linear|||||0.4|-0.7|0.21
72615382|NCT02347787|144761172|SUPERIORITY||Risk Difference (RD)|-0.5||||0.21|TWO_SIDED|95.0|-2.2|1.2|||Regression, Linear|||||1.2|-2.2|0.21
72615383|NCT02347787|144761173|SUPERIORITY||Risk Difference (RD)|-6.3||||0.21|TWO_SIDED|95.0|-14.3|1.8|||Regression, Linear|||||1.8|-14.3|0.21
72615384|NCT02347787|144761174|SUPERIORITY|||||||0.41|||||||Regression, Linear|||||||0.41
72615385|NCT02347787|144761175|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|||||||<0.001
72615386|NCT02347787|144761176|SUPERIORITY||Odds Ratio (OR)|1.0||||0.98|TWO_SIDED|95.0|0.6|1.5|||Regression, Logistic|||||1.5|0.6|0.98
72615387|NCT02347787|144761178|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|||||||<0.001
72615388|NCT02347787|144761179|SUPERIORITY|||||||0.02|||||||Regression, Logistic|||||||0.02
72615389|NCT02347787|144761180|SUPERIORITY|||||||0.04|||||||Regression, Logistic|||||||0.04
72615390|NCT02347787|144761182|SUPERIORITY|||||||0.09|||||||Regression, Linear|||||||0.09
72615391|NCT02347787|144761183|SUPERIORITY|||||||0.06|||||||Regression, Linear|||||||0.06
72615392|NCT01059851|144761184|NON_INFERIORITY_OR_EQUIVALENCE|"AUC(0-∞) GMR = AUC(0-∞) GM for Severe Renal Impairment Participants ÷ AUC(0-∞) GM for Healthy Participants.~A 90% CI for the AUC(0-∞) GMR was computed from the ANCOVA model. As prespecified by the analysis plan, if the 90% CI for the AUC(0-∞) GMR was contained within the interval \[0.50, 2.00\], then the hypothesis would be met and the AUC(0-∞) of suvorexant would be similar in both groups of participants. That is, if the true ratio of the GM AUC(0-∞) is greater than 0.50 and no more than 2.00."|AUC(0-∞) Geometric Mean Ratio|1.22|||||TWO_SIDED|90.0|0.93|1.6|||ANCOVA|||"The geometric mean (GM) for each participant group and the corresponding 95% confidence interval (CI) were calculated for AUC(0-∞) using an analysis of covariance (ANCOVA) model.~The AUC(0-∞) geometric mean ratio (GMR) of the 2 participant groups was used to test the primary hypothesis, which was that the AUC(0-∞) of suvorexant following a single oral dose would be similar between participants with renal impairment and healthy matched control participants."||1.60|0.93|
72615393|NCT05643794|144761193|SUPERIORITY||Difference from Placebo|-0.54||||0.129|TWO_SIDED|95.0|-1.24|0.16|||Longitudinal linear mixed effect model||The difference presented is RLZ 12 weeks minus Placebo.|||0.16|-1.24|0.129
72615394|NCT05643794|144761196|SUPERIORITY||Difference from Placebo|-0.51||||0.358|TWO_SIDED|95.0|-1.6|0.58|||Longitudinal mixed effects model||The difference presented is RLZ 24 weeks minus PBO 24 weeks.|||0.58|-1.60|0.358
72615395|NCT05643794|144761197|SUPERIORITY||Difference from Placebo|-8.4||||0.003|TWO_SIDED|95.0|-13.84|-2.96|||Longitudinal mixed effects model||The difference presented is RLZ 12 weeks minus Placebo|||-2.96|-13.84|0.003
72615396|NCT05643794|144761198|SUPERIORITY||Differences from Placebo|0.05||||0.878|TWO_SIDED|95.0|-0.55|0.64|||Longitudinal mixed effects model||The differences presented is RLZ 12 weeks minus Placebo.|||0.64|-0.55|0.878
72615397|NCT05643794|144761199|SUPERIORITY||Difference from Placebo|-0.28||||0.352|TWO_SIDED|95.0|-0.86|0.31|||Longitudinal mixed effects model||The difference presented is RLZ 12 weeks minus Placebo.|||0.31|-0.86|0.352
72615398|NCT04766333|144761221|SUPERIORITY||Odds Ratio (OR)|0.45|||<|0.05|TWO_SIDED|95.0|0.17|1.23|||Regression, Logistic||Healthcare Arm is the reference category|||1.23|0.17|<0.05
72615399|NCT00639379|144761222|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin is 0.65|Odds Ratio (OR)|0.967|||||TWO_SIDED|98.98|0.436|0.967|||Regression, Logistic||Odds ratio is senofilcon A toric / alphafilcon A toric.|Alternative hypothesis is that senofilcon A toric is non-inferior to alphafilcon A toric for proportion of eyes with lens orientation within 5 degrees.||0.967|0.436|
72615400|NCT00639379|144761223|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin = 0.65|Odds Ratio (OR)|1.416|||||TWO_SIDED|98.98|0.68|1.416|||Regression, Logistic||Odds ratio is senofilcon A toric / alphafilcon A toric.|Alternative hypothesis is that senofilcon A toric is non-inferior to alphafilcon A toric for proportion of eyes with lens stability within 5 degrees.||1.416|0.680|
72615401|NCT00639379|144761224|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin = -0.4|Mean Difference (Final Values)|0.1868|STANDARD_ERROR_OF_MEAN|0.0921|||TWO_SIDED|98.98|-0.0517|0.1868|||Mixed Models Analysis||The mean difference is calculated as senofilcon A toric minus alphafilcon A toric.|Alternative hypothesis is that senofilcon A toric is non-inferior to alphafilcon A toric for lens comfort.||0.1868|-0.0517|
72615402|NCT00639379|144761225|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin = -0.4|Mean Difference (Final Values)|-0.01185|STANDARD_ERROR_OF_MEAN|0.08566|||TWO_SIDED|98.98|-0.2337|-0.01185|||Mixed Models Analysis||The mean difference is calculated as senofilcon A toric minus alphafilcon A toric.|Alternative hypothesis is that senofilcon A toric is non-inferior to alphafilcon A toric for subjective vision.||-0.01185|-0.2337|
72615403|NCT00639379|144761226|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin = 0.5|Mean Difference (Final Values)|-0.01267|STANDARD_ERROR_OF_MEAN|0.01265|||TWO_SIDED|98.98|-0.01267|0.01986|||||The mean difference was calculated as senofilcon A toric minus alphafilcon A toric.|Alternative hypothesis is senofilcon A toric is non-inferior to alphafilcon A toric by having a lower level of corneal staining.||0.01986|-0.01267|
72615404|NCT03712852|144761227|SUPERIORITY||Mean Difference (Net)|0.92|||||TWO_SIDED|95.0|0.68|1.17|||||||Multiple univariate analyses for each variable were performed. GT was analyzed by non-parametric Cliff's delta tests to assess group dominance and by a Heteroscedastic ANOVA with Games-Howell posthoc tests. A sensitivities analysis with different types of robust analyses (M-estimators and High Breakdown LTS Estimators, both with Huber's, Hampel's and Biweight's loss functions) was conducted to get an effect-size estimate by means of Bootstrap Bias Corrected and accelerated (BCa) 95% Confidence Intervals.|1.17|0.68|
72615405|NCT03712852|144761228|SUPERIORITY||Median Difference (Final Values)|3.28|||||TWO_SIDED|95.0|3.0|3.55|||||||This outcome was analyzed by posthoc Nemenyi's tests|3.55|3.00|
72615406|NCT03712852|144761229|SUPERIORITY||Mean Difference (Final Values)|0.08|||||TWO_SIDED|95.0|-0.46|2.46|||||||This outcome was analyzed by posthoc Nemenyi's tests|2.46|-0.46|
72615407|NCT03712852|144761230|SUPERIORITY||Mean Difference (Final Values)|0.2|||||TWO_SIDED|95.0|-0.4|0.69|||||||This outcome was analyzed by posthoc Nemenyi's tests|0.69|-0.40|
72615408|NCT03712852|144761231|SUPERIORITY||Mean Difference (Final Values)|3.38|||||TWO_SIDED|95.0|2.96|3.81|||||||CAL was analyzed with both Nemenyi's tests and a Moderated Regression (Treatment by Baseline values)|3.81|2.96|
72615409|NCT02383173|144761245|OTHER|||||||0.445|||||||Generalized Estimating Equation (GEE)|Sandwich estimators were used to adjust for the small number of clusters.||Generalized Estimating Equation (GEE) analyses of post-intervention data were used to account for clustering. We adjusted for age, race, cancer, length of stay and study year.||||0.445
72615410|NCT03677401|144761260|SUPERIORITY|P-value from a Cochran-Mantel- Haenszel (CMH) test stratified by Baseline WI-NRS used for randomization stratification. Value has been adjusted for multiple imputation.||||||0.158|||||||Cochran-Mantel-Haenszel|||At Week 10||||0.158
72615411|NCT03677401|144761261|SUPERIORITY|P-value from a CMH test stratified by Baseline WI-NRS used for randomization stratification. Value has been adjusted for multiple imputation.||||||0.75|||||||Cochran-Mantel-Haenszel|||At Week 4||||0.750
72615412|NCT03677401|144761262|SUPERIORITY|P-value from a CMH test stratified by Baseline WI-NRS used for randomization stratification. Value has been adjusted for multiple imputation||||||0.674|||||||Cochran-Mantel-Haenszel|||At Week 2||||0.674
72615413|NCT03677401|144761263|SUPERIORITY|P-values, least squares means (LS Mean) and standard deviations (LS SD) from an analysis of covariance (ANCOVA) with treatment group and stratification factor as fixed effects, and baseline value as a covariate.||||||0.06|||||||ANCOVA|||At Week 2||||0.060
72622169|NCT03382873|144774351|SUPERIORITY|||||||0.0112|||||||ANOVA|Treatment group, time and their interaction were fixed effects and participants were random effects||||||0.0112
72432086|NCT00797225|144376622|SUPERIORITY||LS Mean Difference|-0.82|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-1.04|-0.59|||Mixed-effects Repeated Measures Model|||Analysis at Week 8. The change from baseline in monthly mean dysmenorrhea scores was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.||-0.59|-1.04|< 0.0001
72554868|NCT00730691|144641522|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.57|STANDARD_ERROR_OF_MEAN|0.781||0.001|TWO_SIDED|95.0|-4.1|-1.03|||Mixed model for repeated measurements|P-values are from an MMRM model with week, Baseline score-by-week and treatment-by-week interaction as factors.||||-1.03|-4.10|0.001
72554869|NCT00730691|144641523|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.114||||0.641|TWO_SIDED|95.0|0.709|1.75|||Regression, Logistic|Logistic regression with explanatory variables for treatment and Baseline HAM-A score.||||1.750|0.709|0.641
72554870|NCT00730691|144641523|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.016||||0.945|TWO_SIDED|95.0|0.643|1.605|||Regression, Logistic|Logistic regression with explanatory variables for treatment and Baseline HAM-A score.||||1.605|0.643|0.945
72554871|NCT00730691|144641523|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.114||||0.641|TWO_SIDED|95.0|0.709|1.749|||Regression, Logistic|Logistic regression with explanatory variables for treatment and Baseline HAM-A score.||||1.749|0.709|0.641
72554872|NCT00730691|144641523|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.427||||0.124|TWO_SIDED|95.0|0.907|2.246|||Regression, Logistic|Logistic regression with explanatory variables for treatment and Baseline HAM-A score.||||2.246|0.907|0.124
72554873|NCT00730691|144641524|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.5|STANDARD_ERROR_OF_MEAN|1.346||0.064|TWO_SIDED|95.0|-5.15|0.14|||Mixed model for repeated measurements|P-values are from an MMRM model with week, Baseline score-by-week and treatment-by-week interaction as factors.||||0.14|-5.15|0.064
72554874|NCT00730691|144641524|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.26|STANDARD_ERROR_OF_MEAN|1.353||0.096|TWO_SIDED|95.0|-4.92|0.4|||Mixed model for repeated measurements|P-values are from an MMRM model with week, Baseline score-by-week and treatment-by-week interaction as factors.||||0.40|-4.92|0.096
72554875|NCT00730691|144641524|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.61|STANDARD_ERROR_OF_MEAN|1.397||0.25|TWO_SIDED|95.0|-4.36|1.14|||Mixed model for repeated measurements|P-values are from an MMRM model with week, Baseline score-by-week and treatment-by-week interaction as factors.||||1.14|-4.36|0.250
72554876|NCT00730691|144641524|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.54|STANDARD_ERROR_OF_MEAN|1.425||0.002|TWO_SIDED|95.0|-7.34|-1.73|||Mixed model for repeated measurements|P-values are from an MMRM model with week, Baseline score-by-week and treatment-by-week interaction as factors.||||-1.73|-7.34|0.002
72554877|NCT02554890|144641537|OTHER||expon. back transformed from LS means|0.7143|||<|0.0001|TWO_SIDED|95.0|0.6315|0.808||ANCOVA model for a log-scaled response with treatment group as a class variable and biomarker baseline value in logarithmic scale as a continuous covariate.|ANCOVA||Geometric Mean Ratio: Sacubitril/ Valsartan vs. Enalapril|||0.8080|0.6315|<.0001
72554878|NCT02554890|144641541|OTHER||exponentially back transformed from LS m|0.8487||||0.0011|TWO_SIDED|95.0|0.7694|0.9361|||ANCOVA||Geometric Mean Ratio: Sacubitril/ Valsartan vs. Enalapril|||0.9361|0.7694|0.0011
72554879|NCT02554890|144641542|OTHER||expon. back transformed from LS means|1.6487|||<|0.0001|TWO_SIDED|95.0|1.4559|1.8669|||ANCOVA||Geometric Mean Ratio: Sacubitril/ Valsartan vs. Enalapril|||1.8669|1.4559|<.0001
72554880|NCT02554890|144641543|OTHER||expon. back transformed from LS means|1.4186|||<|0.0001|TWO_SIDED|95.0|1.3248|1.519|||ANCOVA||Geometric Mean Ratio: Sacubitril/ Valsartan vs. Enalapril|||1.5190|1.3248|<.0001
72554881|NCT02554890|144641544|OTHER||expon. back transformed from LS means|1.4745|||<|0.0001|TWO_SIDED|95.0|1.3752|1.581|||ANCOVA||Geometric Mean Ratio: Sacubitril/ Valsartan vs. Enalapril|||1.5810|1.3752|<.0001
72554882|NCT02554890|144641545|OTHER||expon. back transformed from LS means|0.7133|||<|0.0001|TWO_SIDED|95.0|0.6171|0.8245||ANCOVA model for a log-scaled response with treatment group as a class variable and biomarker baseline value in logarithmic scale as a continuous covariate.|ANCOVA||Geometric Mean Ratio: Sacubitril/Valsartan vs. Enalapril|||0.8245|0.6171|<.0001
72554883|NCT03649477|144641546|SUPERIORITY||Mean Difference (Net)|-1.202||||0.3493|TWO_SIDED|95.0|-3.729|1.324||0.05 threshold for statistical significance|Mixed Models Analysis|||||1.324|-3.729|0.3493
72554884|NCT03649477|144641546|SUPERIORITY||Mean Difference (Net)|-3.136||||0.0162|TWO_SIDED|95.0|-5.685|-0.586||0.05 threshold for statistical significance|Mixed Models Analysis|||||-0.586|-5.685|0.0162
72554885|NCT03649477|144641547|SUPERIORITY||Mean Difference (Net)|-0.608||||0.6001|TWO_SIDED|95.0|-2.89|1.674||0.05 threshold for statistical significance|Mixed Models Analysis|||||1.674|-2.890|0.6001
72554886|NCT03649477|144641547|SUPERIORITY||Mean Difference (Net)|-0.764||||0.5143|TWO_SIDED|95.0|-3.068|1.541||0.05 threshold for statistical significance|Mixed Models Analysis|||||1.541|-3.068|0.5143
72554887|NCT03649477|144641548|SUPERIORITY||Mean Difference (Net)|0.183||||0.9144|TWO_SIDED|95.0|-3.175|3.541||0.05 threshold for statistical significance|Mixed Models Analysis|||||3.541|-3.175|0.9144
72554888|NCT03649477|144641548|SUPERIORITY||Mean Difference (Net)|-3.812||||0.0266|TWO_SIDED|95.0|-7.177|-0.446||0.05 threshold for statistical significance|Mixed Models Analysis|||||-0.446|-7.177|0.0266
72554889|NCT03649477|144641549|SUPERIORITY||Mean Difference (Net)|-0.312||||0.1598|TWO_SIDED|95.0|-0.748|0.125||0.05 threshold for statistical significance|Mixed Models Analysis|||||0.125|-0.748|0.1598
72554890|NCT03649477|144641549|SUPERIORITY||Mean Difference (Net)|-0.498||||0.0266|TWO_SIDED|95.0|-0.937|-0.059||0.05 threshold for statistical significance|Mixed Models Analysis|||||-0.059|-0.937|0.0266
72554891|NCT03649477|144641550|SUPERIORITY||Mean Difference (Net)|-1.085||||0.2479|TWO_SIDED|95.0|-2.932|0.761||0.05 threshold for statistical significance|Mixed Models Analysis|||||0.761|-2.932|0.2479
72554892|NCT03649477|144641550|SUPERIORITY||Mean Difference (Net)|-2.412||||0.0114|TWO_SIDED|95.0|-4.276|-0.548||0.05 for statistical significance|Mixed Models Analysis|||||-0.548|-4.276|0.0114
72554893|NCT01097577|144641563|SUPERIORITY|||||||0.18|||||||ANOVA|||This study was designed to determine if pregabalin is an effective regimen for postoperative pain control following PRK. We hypothesized that there will be at least a 10% improvement in pain after PRK using a scheduled pregabalin dosing regimen compared to placebo. A power analysis was completed to determine the number of patients necessary.||||0.180
72554894|NCT01097577|144641564|SUPERIORITY|||||||0.207|||||||ANOVA|||||||0.207
72615414|NCT03677401|144761263|SUPERIORITY|||||||0.401||||||P-values, LS Mean and LS SD from ANCOVA with treatment group and stratification factor as fixed effects, and baseline value as a covariate.|ANCOVA|||At Week 4||||0.401
72615415|NCT03677401|144761263|SUPERIORITY|P-values, LS Mean and LS SD from ANCOVA with treatment group and stratification factor as fixed effects, and baseline value as a covariate.||||||0.185|||||||ANCOVA|||At Week 6||||0.185
72615416|NCT03677401|144761263|SUPERIORITY|P-values, LS Mean and LS SD from ANCOVA with treatment group and stratification factor as fixed effects, and baseline value as a covariate.||||||0.164|||||||ANCOVA|||At Week 10||||0.164
72615417|NCT03677401|144761264|SUPERIORITY|||||||0.283||||||P-value from a CMH test stratified by Baseline WI-NRS used for randomization stratification. Value has been adjusted for multiple imputation.|Cochran-Mantel-Haenszel|||At Week 2||||0.283
72615418|NCT03677401|144761264|SUPERIORITY|||||||0.701||||||P-value from a CMH test stratified by Baseline WI-NRS used for randomization stratification. Value has been adjusted for multiple imputation.|Cochran-Mantel-Haenszel|||At Week 4||||0.701
72615419|NCT03677401|144761264|SUPERIORITY|||||||0.033||||||P-value from a CMH test stratified by Baseline WI-NRS used for randomization stratification. Value has been adjusted for multiple imputation.|Cochran-Mantel-Haenszel|||At Week 10||||0.033
72615420|NCT03677401|144761265|SUPERIORITY|||||||0.797||||||P-values, LS mean and SD from ANCOVA with treatment group and stratification factor as fixed effects, and baseline value as a covariate.|ANCOVA|||At Week 10||||0.797
72615421|NCT03677401|144761266|SUPERIORITY|||||||0.845||||||P-values, LS mean and SD from ANCOVA with treatment group and stratification factor as fixed effects, and baseline value as a covariate.|ANCOVA|||At Week 10||||0.845
72615422|NCT03677401|144761267|SUPERIORITY|||||||0.385||||||P-values, LS mean and SD from ANCOVA with treatment group and stratification factor as fixed effects, and baseline value as a covariate.|ANCOVA|||At Week 2||||0.385
72615423|NCT03677401|144761267|SUPERIORITY|||||||0.786||||||P-values, LS mean and SD from ANCOVA with treatment group and stratification factor as fixed effects, and baseline value as a covariate.|ANCOVA|||At Week 4||||0.786
72615424|NCT03677401|144761267|SUPERIORITY|||||||0.502||||||P-values, LS mean and SD from ANCOVA with treatment group and stratification factor as fixed effects, and baseline value as a covariate.|ANCOVA|||At Week 10||||0.502
72615425|NCT03677401|144761268|SUPERIORITY|||||||0.197||||||P-values, LS mean and SD from ANCOVA with treatment group and stratification factor as fixed effects, and baseline value as a covariate.|ANCOVA|||At Week 2||||0.197
72504977|NCT01462292|144541159|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.821||||0.898|TWO_SIDED|95.0|-12.034|13.676||No adjustment for multiplicity was made, so p-values should not be used to make conclusions with regards to statistical significance|ANCOVA|Model includes terms for Treatment, Centre Grouping and Baseline Muscle Strength Total Score||Treatment difference: Placebo Vs GSK2402968 6mg||13.676|-12.034|0.898
72554895|NCT01097577|144641565|SUPERIORITY|||||||0.283|||||||ANOVA|||||||0.283
72554896|NCT01097577|144641566|SUPERIORITY|Question 1: Pain at its worst||||||0.223|||||||ANOVA|||||||0.223
72554897|NCT01097577|144641567|SUPERIORITY|||||||0.311|||||||ANOVA|||||||0.311
72554898|NCT01097577|144641568|SUPERIORITY|||||||0.581|||||||t-test, 2 sided|||Days to Heal, OD||||0.581
72554899|NCT01097577|144641568|SUPERIORITY|||||||0.307|||||||t-test, 2 sided|||Days to Heal, OS||||0.307
72554900|NCT00748072|144641569|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.45||||0.01|TWO_SIDED|95.0|0.24|0.85|||Chi-squared|||The sample size was calculated by the difference in post-biopsy bleeding complications. Since the presence of bleeding was demonstrated in about 30-40 % in our previous observational study, we hypothesized a reduction risk of 0.50 and an absolute reduction of risk from 0.40 to 0.20. The sample size of the study for a power of 0.80 and a significance level \<0.05 was calculated in 158 patients.||0.85|0.24|0.01
72554901|NCT04493684|144641648|OTHER||Geometric Least Square Mean Ratio|2.462|||||TWO_SIDED|90.0|1.823|3.323|||Mixed Models Analysis|||The mixed model was used to estimate Food Effect for the log transformed parameter AUC (0-24). Analysis was performed using fed/ fasted state and tablet/ PiB as fixed effects and participant as a random effect.||3.323|1.823|
72554902|NCT04493684|144641648|OTHER||Geometric Least Square Mean Ratio|1.381|||||TWO_SIDED|90.0|1.223|1.56|||Mixed Models Analysis|||The mixed model was used to estimate Tablet vs. PiB effect for the log transformed parameter AUC (0-24). Analysis was performed using the independent variables included a fixed effect for treatment (PiB or Tablet) and period, and participant as a random effect.||1.56|1.223|
72554903|NCT04493684|144641649|OTHER||Geometric Least Square Mean Ratio|2.103|||||TWO_SIDED|90.0|1.629|2.717|||Mixed Models Analysis|||The mixed model was used to estimate Food Effect for the log transformed parameter AUC (0-inf). Analysis was performed using fed/ fasted state and tablet/ PiB as fixed effects and participant as a random effect.||2.717|1.629|
72554904|NCT04493684|144641649|OTHER||Geometric Least Square Mean Ratio|1.351|||||TWO_SIDED|90.0|1.22|1.497|||Mixed Models Analysis|||The mixed model was used to estimate Tablet vs. PiB effect for the log transformed parameter AUC (0-inf). Analysis was performed using the independent variables included a fixed effect for treatment (PiB or Tablet) and period, and participant as a random effect.||1.497|1.22|
72554905|NCT04493684|144641650|OTHER||Geometric Least Square Mean Ratio|2.307|||||TWO_SIDED|90.0|1.668|3.19|||Mixed Models Analysis|||The mixed model was used to estimate Food Effect for the log transformed parameter Cmax. Analysis was performed using fed/ fasted state and tablet/ PiB as fixed effects and participant as a random effect.||3.19|1.668|
72554906|NCT04493684|144641650|OTHER||Geometric Least Square Mean Ratio|1.372|||||TWO_SIDED|90.0|1.19|1.582|||Mixed Models Analysis|||The mixed model was used to estimate Tablet vs. PiB effect for the log transformed parameter Cmax. Analysis was performed using the independent variables included a fixed effect for treatment (PiB or Tablet) and period, and participant as a random effect.||1.582|1.19|
72554907|NCT04870606|144641714|SUPERIORITY||Mean Difference (Final Values)|0.025||||0.0181|ONE_SIDED||||||Cochran-Mantel-Haenszel|||||||0.0181
72554908|NCT04870606|144641715|SUPERIORITY||Mean Difference (Final Values)|0.025||||0.1223|ONE_SIDED||||||Chi-squared|||||||0.1223
72554909|NCT04870606|144641716|SUPERIORITY||Mean Difference (Final Values)|0.025||||0.0038|ONE_SIDED||||||t-test, 2 sided|||||||0.0038
72554910|NCT05152576|144641719|SUPERIORITY||Rate Difference|41.4|||<|0.001|TWO_SIDED|95.0|23.5|59.3||Based on CMH test stratified by baseline investigator-rated FWS-FHL at maximum.|Cochran-Mantel-Haenszel|||Confidence interval for responder rate is calculated using normal approximation.||59.3|23.5|<0.001
72615426|NCT03677401|144761268|SUPERIORITY|||||||0.694||||||P-values, LS mean and SD from ANCOVA with treatment group and stratification factor as fixed effects, and baseline value as a covariate.|ANCOVA|||At Week 4||||0.694
72615427|NCT03677401|144761268|SUPERIORITY|||||||0.916||||||P-values, LS mean and SD from ANCOVA with treatment group and stratification factor as fixed effects, and baseline value as a covariate.|ANCOVA|||At Week 10||||0.916
72615428|NCT01177410|144761270|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.369||||0.0432|TWO_SIDED|95.0|1.027|5.467|||Regression, Logistic|||||5.467|1.027|0.0432
72615429|NCT01177410|144761270|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.267||||0.6059|TWO_SIDED|95.0|0.515|3.115|||Regression, Logistic|||||3.115|0.515|0.6059
72615430|NCT01177410|144761271|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.232||||0.0327|TWO_SIDED|95.0|1.068|4.664|||Proportional Odds Model|||Proportional odds model was used to compare the number of months the subjects are responders.||4.664|1.068|0.0327
72615431|NCT01177410|144761271|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.148||||0.726|TWO_SIDED|95.0|0.531|2.483|||Proportional Odds Model|||||2.483|0.531|0.7260
72615432|NCT01846871|144761278|OTHER|||||||0.7|||||||t-test, 2 sided|||||||0.70
72615433|NCT01846871|144761279|OTHER|||||||0.028|||||||t-test, 2 sided|||||||0.028
72615434|NCT01846871|144761280|OTHER|||||||0.0019|||||||t-test, 2 sided|||||||0.0019
72615435|NCT01846871|144761281|OTHER|||||||0.033|||||||t-test, 2 sided|||||||0.033
72615436|NCT00924482|144761288|SUPERIORITY_OR_OTHER_LEGACY||Correlation Coefficient (R^2)|0.63||||||95.0|||||Regression, Linear|Linear regression between the average of six thermodilution cardiac output measurements was compared to the average of six ECOM output measurements||||||
72615437|NCT00875667|144761300|SUPERIORITY||Stratified Hazard Ratio|0.63||||0.012|TWO_SIDED|95.0|0.43|0.9||Stratification factors were: time from diagnosis to first dose, time from last prior anti-lymphoma therapy to first dose, prior stem cell transplant, and MIPI at baseline|Stratified Log Rank Test|||||0.90|0.43|0.012
72615438|NCT00875667|144761301|SUPERIORITY||Stratified Hazard Ratio|0.6||||0.003|TWO_SIDED|95.0|0.43|0.85||Stratification factors were: time from diagnosis to first dose, time from last prior anti-lymphoma therapy to first dose, prior stem cell transplant, and MIPI at baseline|Stratified Log Rank Test||The weights are based on observed events at the time the third DMC meeting was held and based on the difference between observed and expected events at the time of the primary analysis.|||0.85|0.43|0.003
72615439|NCT00875667|144761302|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
72615440|NCT00875667|144761303|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
72615441|NCT00875667|144761304|SUPERIORITY||Hazard Ratio (HR)|0.7||||0.421|TWO_SIDED|95.0|0.29|1.68|||Log Rank|||||1.68|0.29|0.421
72615442|NCT00875667|144761305|SUPERIORITY||Hazard Ratio (HR)|0.95||||0.875|TWO_SIDED|95.0|0.52|1.74|||Log Rank|||||1.74|0.52|0.875
72615443|NCT00875667|144761306|SUPERIORITY|||||||0.313|||||||Chi-squared|||||||0.313
72432087|NCT00797225|144376622|SUPERIORITY||LS Mean Difference|-0.41|STANDARD_ERROR_OF_MEAN|0.12||0.0005|TWO_SIDED|95.0|-0.65|-0.18|||Mixed-effects Repeated Measures Model|||Analysis at Week 12. The change from baseline in monthly mean dysmenorrhea scores was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.||-0.18|-0.65|0.0005
72615444|NCT00875667|144761307|SUPERIORITY|||||||0.465|||||||Chi-squared|||||||0.465
72615445|NCT00875667|144761308|SUPERIORITY||Hazard Ratio (HR)|0.62||||0.005|TWO_SIDED|95.0|0.45|0.87|||Log Rank|||||0.87|0.45|0.005
72615446|NCT00875667|144761309|SUPERIORITY||Hazard Ratio (HR)|0.63||||0.003|TWO_SIDED|95.0|0.46|0.86|||Log Rank|||||0.86|0.46|0.003
72615447|NCT00875667|144761310|SUPERIORITY||Hazard Ratio (HR)|0.74||||0.046|TWO_SIDED|95.0|0.54|1.0|||Log Rank|||||1.00|0.54|0.046
72615448|NCT00875667|144761311|SUPERIORITY||Hazard Ratio (HR)|0.78||||0.095|TWO_SIDED|95.0|0.58|1.05|||Log Rank|||||1.05|0.58|0.095
72615449|NCT00875667|144761312|SUPERIORITY||Hazard Ratio (HR)|3.91|||<|0.001|TWO_SIDED|95.0|1.95|7.85|||Log Rank|||||7.85|1.95|<0.001
72615450|NCT00875667|144761313|SUPERIORITY||Hazard Ratio (HR)|2.06|||<|0.004|TWO_SIDED|95.0|1.24|3.42|||Log Rank|||||3.42|1.24|<0.004
72615451|NCT00875667|144761314|SUPERIORITY||Hazard Ratio (HR)|0.89||||0.519|TWO_SIDED|95.0|0.62|1.28|||Log Rank|||||1.28|0.62|0.519
72615452|NCT00875667|144761315|SUPERIORITY||Hazard Ratio (HR)|0.91||||0.558|TWO_SIDED|95.0|0.67|1.25|||Log Rank|||||1.25|0.67|0.558
72615453|NCT00412451|144761357|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.001||||0.131|TWO_SIDED|95.0|0.001|999.999|||Fisher Exact|||||999.999|0.001|0.131
72615454|NCT00412451|144761357|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.562||||0.67|TWO_SIDED|95.0|0.132|2.4|||Fisher Exact|||||2.400|0.132|0.670
72615455|NCT00412451|144761357|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.346||||0.372||95.0|0.07|1.703|||Fisher Exact|||||1.703|0.070|0.372
72615456|NCT00923702|144761370|NON_INFERIORITY|To test for non-inferiority of antibody concentrations in different dose groups, log-transformed mean MFIs in linear regression models were used to obtain MFI ratios and their corresponding 95% confidence intervals (CIs). Antibody titres at months 0, 7, 12, 36 and 48 were compared and non-inferiority was inferred when the lower bound of the confidence interval of the ratio of the immunogenicity measures exceeded 0.5.|Risk Ratio (RR)|0.5|||||ONE_SIDED||||||Regression, Linear||The lower bound of the 95% CI ratio of immunogeneicity measures was used instead. No p-values were estimated.|||||
72615457|NCT00923702|144761371|SUPERIORITY||Vaccine efficacy|95.0|||||TWO_SIDED|||||||||||||
72615458|NCT01692756|144761407|SUPERIORITY|||||||0.33|||||||Kruskal-Wallis|||||||0.33
72615459|NCT01692756|144761408|SUPERIORITY|||||||0.08|||||||Kruskal-Wallis|||||||0.08
72615460|NCT01692756|144761409|SUPERIORITY|||||||0.93|||||||Kruskal-Wallis|||||||0.93
72615461|NCT01692756|144761410|SUPERIORITY|||||||0.13|||||||Kruskal-Wallis|||||||0.13
72615462|NCT01692756|144761411|SUPERIORITY|||||||0.15|||||||Kruskal-Wallis|||||||0.15
72615463|NCT01692756|144761412|SUPERIORITY|||||||0.003|||||||Kruskal-Wallis|||||||.003
72615464|NCT01692756|144761413|SUPERIORITY|||||||0.007|||||||Kruskal-Wallis|||||||.007
72615465|NCT01692756|144761414|SUPERIORITY|||||||0.63|||||||Kruskal-Wallis|||||||.63
72615466|NCT01692756|144761415|SUPERIORITY|||||||0.17|||||||Kruskal-Wallis|||||||0.17
72615467|NCT01692756|144761416|SUPERIORITY|||||||0.62|||||||Kruskal-Wallis|||||||.62
72615468|NCT01692756|144761417|SUPERIORITY|||||||0.02|||||||Kruskal-Wallis|||||||.02
72615469|NCT01692756|144761418|SUPERIORITY|||||||0.2|||||||Kruskal-Wallis|||||||.20
72615470|NCT01692756|144761419|SUPERIORITY|||||||0.87|||||||Kruskal-Wallis|||||||.87
72615471|NCT02969018|144761424|OTHER||Least Squares Mean Difference|-8.64|STANDARD_ERROR_OF_MEAN|2.232||0.0005|TWO_SIDED|90.0|-12.33|-4.95||Hochberg adjusted p-value|Mixed Models Analysis|||||-4.95|-12.33|0.0005
72615472|NCT02969018|144761424|OTHER||Least Squares Mean Difference|-3.34|STANDARD_ERROR_OF_MEAN|2.206||0.0963|TWO_SIDED|90.0|-6.99|0.3||Hochberg adjusted p-value|Mixed Models Analysis|||||0.30|-6.99|0.0963
72615473|NCT02969018|144761424|OTHER||Least Squares Mean Difference|-7.07|STANDARD_ERROR_OF_MEAN|2.233||0.0046|TWO_SIDED|90.0|-10.76|-3.37||Hochberg adjusted p-value|Mixed Models Analysis|||||-3.37|-10.76|0.0046
72615474|NCT02969018|144761424|OTHER||Least Squares Mean Difference|-2.93|STANDARD_ERROR_OF_MEAN|2.238||0.0963|TWO_SIDED|90.0|-6.63|0.77||Hochberg adjusted p-value|Mixed Models Analysis|||||0.77|-6.63|0.0963
72615475|NCT02969018|144761424|OTHER||Least Squares Mean Difference|-10.07|STANDARD_ERROR_OF_MEAN|2.152|<|0.0001|TWO_SIDED|90.0|-13.63|-6.51||Hochberg adjusted p-value|Mixed Models Analysis|||||-6.51|-13.63|<0.0001
72615476|NCT02969018|144761424|OTHER||Least Squares Mean Difference|-6.06|STANDARD_ERROR_OF_MEAN|2.255||0.0158|TWO_SIDED|90.0|-9.79|-2.33||Hochberg adjusted p-value|Mixed Models Analysis|||||-2.33|-9.79|0.0158
72615477|NCT02969018|144761424|OTHER||Least Squares Mean Difference|-4.66|STANDARD_ERROR_OF_MEAN|2.163||0.0488|TWO_SIDED|90.0|-8.24|-1.09||Hochberg adjusted p-value|Mixed Models Analysis|||||-1.09|-8.24|0.0488
72615478|NCT02969018|144761425|OTHER||Odds Ratio (OR)|10.0|||||TWO_SIDED|90.0|2.95|33.87|||||||Logistic regression|33.87|2.95|
72615479|NCT02969018|144761425|OTHER||Odds Ratio (OR)|2.12|||||TWO_SIDED|90.0|0.61|7.36|||||||Logistic regression|7.36|0.61|
72615480|NCT02969018|144761425|OTHER||Odds Ratio (OR)|9.09|||||TWO_SIDED|90.0|2.71|30.48|||||||Logistic regression|30.48|2.71|
72615481|NCT02969018|144761425|OTHER||Odds Ratio (OR)|2.11|||||TWO_SIDED|90.0|0.59|7.55|||||||Logistic regression|7.55|0.59|
72615482|NCT02969018|144761425|OTHER||Odds Ratio (OR)|41.67|||||TWO_SIDED|90.0|10.8|160.68|||||||Logistic regression|160.68|10.80|
72615483|NCT02969018|144761425|OTHER||Odds Ratio (OR)|2.11|||||TWO_SIDED|90.0|0.59|7.55|||||||Logistic regression|7.55|0.59|
72615484|NCT02969018|144761425|OTHER||Odds Ratio (OR)|3.86|||||TWO_SIDED|90.0|1.17|12.74|||||||Logistic regression|12.74|1.17|
72615485|NCT02969018|144761426|OTHER||Least Squares Mean Difference|-9.0|STANDARD_ERROR_OF_MEAN|1.47|<|0.0001|TWO_SIDED|90.0|-11.43|-6.57|||Mixed Models Analysis|||||-6.57|-11.43|<0.0001
72615486|NCT02969018|144761426|OTHER||Least Squares Mean Difference|-7.99|STANDARD_ERROR_OF_MEAN|1.502|<|0.0001|TWO_SIDED|90.0|-10.48|-5.51|||Mixed Models Analysis|||||-5.51|-10.48|<0.0001
72615487|NCT04018001|144761444|SUPERIORITY|||||||0.0115|||||||Chi-squared|||||||0.0115
72615488|NCT04018001|144761444|SUPERIORITY||Odds Ratio (OR)|1.410198||||0.0227|TWO_SIDED|95.0|1.0492535|1.8953079||To better assess true effect of treatment,analysis with participant's baseline characteristic was adjusted to remove influence on the outcome measure.|Regression, Logistic|||||1.8953079|1.0492535|0.0227
72615489|NCT04018001|144761445|SUPERIORITY|||||||0.3564|||||||t-test, 2 sided|||||||0.3564
72615490|NCT04018001|144761445|SUPERIORITY||Hazard Ratio (HR)|0.9022||||0.2629|TWO_SIDED|95.0|0.7534|1.0803||To better assess true effect of treatment,analysis with participant's baseline characteristic was adjusted to remove influence on the outcome measure.|Regression, Cox|||||1.0803|0.7534|0.2629
72615491|NCT04018001|144761446|SUPERIORITY|||||||0.0123|||||||t-test, 2 sided|||||||0.0123
72615492|NCT04018001|144761446|SUPERIORITY||Difference in Least Squares (LS) Means|0.0300853||||0.0047|TWO_SIDED|95.0|0.0092322|0.0509385||To better assess true effect of treatment,analysis with participant's baseline characteristic was adjusted to remove influence on the outcome measure.|Generalized linear model|||||0.0509385|0.0092322|0.0047
72615493|NCT04018001|144761447|SUPERIORITY|||||||0.0002|||||||Chi-squared|||||||0.0002
72615494|NCT04018001|144761447|SUPERIORITY||Odds Ratio (OR)|1.7910474||||0.0002|TWO_SIDED|95.0|1.3167136|2.4362554||To better assess true effect of treatment,analysis with participant's baseline characteristic was adjusted to remove influence on the outcome measure.|Regression, Logistic|||||2.4362554|1.3167136|0.0002
72615495|NCT04018001|144761448|SUPERIORITY|||||||0.4071|||||||t-test, 2 sided|||||||0.4071
72615496|NCT04018001|144761448|SUPERIORITY||Difference in LS Means|0.0104065||||0.6143|TWO_SIDED|95.0|-0.030062|0.0508746||To better assess true effect of treatment,analysis with participant's baseline characteristic was adjusted to remove influence on the outcome measure.|Generalized linear model|||||0.0508746|-0.030062|0.6143
72615497|NCT04018001|144761449|SUPERIORITY|||||||0.001|||||||Chi-squared|||||||0.0010
72615498|NCT04018001|144761449|SUPERIORITY||Odds Ratio (OR)|1.5211586||||0.0025|TWO_SIDED|95.0|1.1594614|1.9956882||To better assess true effect of treatment,analysis with participant's baseline characteristic was adjusted to remove influence on the outcome measure.|Regression, Logistic|||||1.9956882|1.1594614|0.0025
72615499|NCT04018001|144761450|SUPERIORITY|||||||0.4595|||||||t-test, 2 sided|||||||0.4595
72615500|NCT04018001|144761450|SUPERIORITY||Hazard Ratio (HR)|1.1225||||0.3354|TWO_SIDED|95.0|0.8873|1.4201||To better assess true effect of treatment,analysis with participant's baseline characteristic was adjusted to remove influence on the outcome measure.|Regression, Cox|||||1.4201|0.8873|0.3354
72615501|NCT04018001|144761451|SUPERIORITY|||||||0.113|||||||t-test, 2 sided|||||||0.1130
72615502|NCT04018001|144761451|SUPERIORITY||Difference in LS Means|0.0151242||||0.1194|TWO_SIDED|95.0|-0.003908|0.0341568||To better assess true effect of treatment,analysis with participant's baseline characteristic was adjusted to remove influence on the outcome measure.|Generalized linear model|||||0.0341568|-0.003908|0.1194
72615503|NCT04018001|144761452|SUPERIORITY|||||||0.02|||||||Chi-squared|||||||0.0200
72615504|NCT04018001|144761452|SUPERIORITY||Odds Ratio (OR)|1.4143816||||0.0364|TWO_SIDED|95.0|1.0221455|1.9571335||To better assess true effect of treatment,analysis with participant's baseline characteristic was adjusted to remove influence on the outcome measure.|Regression, Logistic|||||1.9571335|1.0221455|0.0364
72615505|NCT04018001|144761453|SUPERIORITY|||||||0.9031|||||||t-test, 2 sided|||||||0.9031
72615506|NCT04018001|144761453|SUPERIORITY||Difference in LS Means|-0.008587||||0.6376|TWO_SIDED|95.0|-0.044317|0.0271416||To better assess true effect of treatment,analysis with participant's baseline characteristic was adjusted to remove influence on the outcome measure.|Generalized linear model|||||0.0271416|-0.044317|0.6376
72615507|NCT04018001|144761454|SUPERIORITY|||||||0.3584|||||||Chi-squared|||||||0.3584
72615508|NCT04018001|144761454|SUPERIORITY||Odds Ratio (OR)|1.1077385||||0.451|TWO_SIDED|95.0|0.8489444|1.4454238||To better assess true effect of treatment,analysis with participant's baseline characteristic was adjusted to remove influence on the outcome measure.|Regression, Logistic|||||1.4454238|0.8489444|0.4510
72615509|NCT04018001|144761455|SUPERIORITY|||||||0.0624|||||||Chi-squared|||||||0.0624
72615510|NCT04018001|144761456|SUPERIORITY|||||||0.4914|||||||Chi-squared|||||||0.4914
72615511|NCT03925220|144761523|SUPERIORITY||Prevalence Ratio (PR)|2.86|||<|0.001|TWO_SIDED|95.0|2.02|4.04||"At 3 months:~Parent-reported frequency of conversations on drinking alcohol"|Generalized estimation|||A sample size of 400 parents and children was calculated to yield 80% power to detect one or more differences between the intervention and control arms, of 45% in talking about alcohol, 20% about marijuana, and 20% about other drugs, using a two-sided Bonferroni-corrected 1.5% level of significance (based on estimates from the pilot trial).||4.04|2.02|<0.001
72615512|NCT03925220|144761523|SUPERIORITY||Prevalence Ratio [PR]|2.4|||<|0.001|TWO_SIDED|95.0|1.67|3.45||"At 3 months:~Parent-reported frequency of conversations on using e-cigarettes or vaping"|Generalized estimation|||||3.45|1.67|<0.001
72615513|NCT03925220|144761523|SUPERIORITY||Prevalence Ratio [PR]|2.36|||<|0.001|TWO_SIDED|95.0|1.62|3.43||"At 3 months:~Parent-reported frequency of conversations on using marijuana"|Generalized estimation|||||3.43|1.62|<0.001
72615514|NCT03925220|144761523|SUPERIORITY||Prevalence Ratio [PR]|3.45|||<|0.001|TWO_SIDED|95.0|2.34|5.08||"At 3 months:~Parent-reported frequency of conversations on smoking cigarettes"|Generalized estimation|||||5.08|2.34|<0.001
72615515|NCT03925220|144761523|SUPERIORITY||Prevalence Ratio [PR]|2.47|||<|0.001|TWO_SIDED|95.0|1.58|3.86||"At 3 months:~Parent-reported frequency of conversations on using other drugs"|Generalized estimation|||||3.86|1.58|<0.001
72615516|NCT03925220|144761523|SUPERIORITY||Prevalence Ratio [PR]|1.45||||0.04|TWO_SIDED|95.0|1.02|2.06||"At 18 months:~Parent-reported frequency of conversations on drinking alcohol"|Generalized estimation|||||2.06|1.02|0.04
72615517|NCT03925220|144761524|SUPERIORITY||Prevalence Ratio (PR)|1.31|||<|0.001|TWO_SIDED|95.0|1.18|1.45||"At 3 months:~Parent-reported have warned your child about the dangers of drinking alcohol and using drugs"|Generalized estimation|||||1.45|1.18|<0.001
72615518|NCT03925220|144761524|SUPERIORITY||Prevalence Ratio [PR]|1.55|||<|0.001|TWO_SIDED|95.0|1.32|1.83||"At 3 months:~Parent-reported 'have talked to your child about how to handle offers of alcoholic drinks and drugs'"|Generalized estimation|||||1.83|1.32|<0.001
72615519|NCT03925220|144761524|SUPERIORITY||Prevalence Ratio [PR]|2.13|||<|0.001|TWO_SIDED|95.0|1.73|2.63||"At 3 months:~Parent-reported 'have given your child rules to obey about drinking alcohol and using drugs'"|Generalized estimation|||||2.63|1.73|<0.001
72554911|NCT05152576|144641719|SUPERIORITY||Rate Difference|38.2|||<|0.001|TWO_SIDED|95.0|19.2|57.1||Based on CMH test stratified by baseline investigator-rated FWS-FHL at maximum.|Cochran-Mantel-Haenszel|||Confidence interval for responder rate is calculated using normal approximation.||57.1|19.2|<0.001
72615520|NCT03925220|144761524|SUPERIORITY||Prevalence Ratio [PR]|1.67||||0.001|TWO_SIDED|95.0|1.25|2.25||"At 3 months:~Parent-reported 'have lectured or given your child a speech about drinking alcohol and using drugs'"|Generalized estimation|||||2.25|1.25|0.001
72615521|NCT03925220|144761524|SUPERIORITY||Prevalence Ratio [PR]|1.51|||<|0.001|TWO_SIDED|95.0|1.21|1.9||"At 3 months:~Parent-reported 'have made a comment to your child about how drinking alcohol and using drugs is bad if a character on TV is drinking or drunk'"|Generalized estimation|||||1.90|1.21|<0.001
72615522|NCT03925220|144761524|SUPERIORITY||Prevalence Ratio [PR]|1.25||||0.008|TWO_SIDED|95.0|1.06|1.47||"At 3 months:~Parent-reported 'have told your child stories of people who drink alcohol, have been drunk, or use drugs'"|Generalized estimation|||||1.47|1.06|0.008
72615523|NCT03925220|144761524|SUPERIORITY||Prevalence Ratio [PR]|1.65|||<|0.001|TWO_SIDED|95.0|1.29|2.1||"At 3 months:~Parent-reported 'have told your child you would be disappointed in her/him if they were to drink alcohol or use drugs'"|Generalized estimation|||||2.10|1.29|<0.001
72615524|NCT03925220|144761524|SUPERIORITY||Prevalence Ratio [PR]|1.64|||<|0.001|TWO_SIDED|95.0|1.24|2.15||"At 3 months:~Parent-reported 'have shown your child information on the web, TV, or in the news about the dangers of drinking alcohol and using drugs'"|Generalized estimation|||||2.15|1.24|<0.001
72615525|NCT03925220|144761524|SUPERIORITY||Prevalence Ratio [PR]|1.65|||<|0.001|TWO_SIDED|95.0|1.4|1.93||"At 3 months:~Parent-reported 'have asked your child about their thoughts and opinions about drinking alcohol and using drugs'"|Generalized estimation|||||1.93|1.40|<0.001
72615526|NCT03925220|144761524|SUPERIORITY||Prevalence Ratio [PR]|1.4||||0.003|TWO_SIDED|95.0|1.12|1.74||"At 18 months:~Parent-reported 'have given your child rules to obey about drinking alcohol and using drugs'"|Generalized estimation|||||1.74|1.12|0.003
72615527|NCT03925220|144761524|SUPERIORITY||Prevalence Ratio [PR]|1.38||||0.01|TWO_SIDED|95.0|1.06|1.78||"At 18 months:~Parent-reported 'have made a comment to your child about how drinking alcohol and using drugs is bad if a character on TV is drinking or drunk'"|Generalized estimation|||||1.78|1.06|0.01
72615528|NCT05561140|144761540|SUPERIORITY||Difference in percentage|-0.3|||=|1|TWO_SIDED|95.0|-10.9|10.2|||Cochran-Mantel-Haenszel|||||10.2|-10.9|=1.0000
72615529|NCT05561140|144761542|SUPERIORITY||Least Square (LS) Mean Difference|-8.2|||=|0.0297|TWO_SIDED|95.0|-15.6|-0.8|||Mixed Models Analysis|||The mixed model for repeated measures (MMRM) model contained fixed effects for treatment group (categorical variable), visit (ordered categorical variable), and treatment group by visit interaction with additional fixed effects for stratification factors.||-0.8|-15.6|=0.0297
72615530|NCT05561140|144761543|SUPERIORITY||Difference in percentage|-8.1|||=|0.3456|TWO_SIDED|95.0|-26.9|10.7|||Cochran-Mantel-Haenszel|||||10.7|-26.9|=0.3456
72615531|NCT01944774|144761544|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Clinical success rate was assumed for the experimental group (Nemonoxacin 500mg) and the control group (Moxifloxacin 400mg) were both 88%. The non-inferiority margin was defined as 15%, one-sided significance value was 0.05 (one-tailed α=0.05), power was 80%, and the assignment ratio was 1:1:1.|Odds Ratio (OR)|0.291||||0.133|TWO_SIDED|95.0|0.058|1.457||Only P values less than 0.05 are considered statistically significant in this study.|Regression, Logistic|||||1.457|0.058|0.133
72622170|NCT03382873|144774352|SUPERIORITY|||||||0.9085|||||||ANOVA|Intervention sequence and sex used as independent predictors in the model.||Comparison of GLB/GLB intervention sequence to GLB+/GLB+ intervention sequence (the primary comparison of interest).||||0.9085
72615532|NCT01944774|144761544|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Clinical success rate was assumed for the experimental group (Nemonoxacin 650mg) and the control group (Moxifloxacin 400mg) were both 88%. The non-inferiority margin was defined as 15%, one-sided significance value was 0.05 (one-tailed α=0.05), power was 80%, and the assignment ratio was 1:1:1.|Odds Ratio (OR)|0.492||||0.423|TWO_SIDED|95.0|0.087|2.788||Only P values less than 0.05 are considered statistically significant in this study.|Regression, Logistic|||||2.788|0.087|0.423
72615533|NCT01944774|144761545|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Clinical success rate was assumed for the experimental group (Nemonoxacin 500mg) and the control group (Moxifloxacin 400mg) were both 88%. The non-inferiority margin was defined as 15%, one-sided significance value was 0.05 (one-tailed α=0.05), power was 80%, and the assignment ratio was 1:1:1.|Odds Ratio (OR)|0.276||||0.118|TWO_SIDED|95.0|0.055|1.385||Only P values less than 0.05 are considered statistically significant in this study.|Regression, Logistic|||||1.385|0.055|0.118
72615534|NCT01944774|144761545|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Clinical success rate was assumed for the experimental group (Nemonoxacin 650mg) and the control group (Moxifloxacin 400mg) were both 88%. The non-inferiority margin was defined as 15%, one-sided significance value was 0.05 (one-tailed α=0.05), power was 80%, and the assignment ratio was 1:1:1.|Odds Ratio (OR)|0.644||||0.636|TWO_SIDED|95.0|0.104|3.999||Only P values less than 0.05 are considered statistically significant in this study.|Regression, Logistic|||||3.999|0.104|0.636
72615535|NCT01944774|144761546|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Clinical success rate was assumed for the experimental group (Nemonoxacin 500mg) and the control group (Moxifloxacin 400mg) were both 88%. The non-inferiority margin was defined as 15%, one-sided significance value was 0.05 (one-tailed α=0.05), power was 80%, and the assignment ratio was 1:1:1.|Odds Ratio (OR)|0.517||||0.456|TWO_SIDED|95.0|0.091|2.93||Only P values less than 0.05 are considered statistically significant in this study.|Regression, Logistic|||||2.930|0.091|0.456
72615536|NCT01944774|144761546|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Clinical success rate was assumed for the experimental group (Nemonoxacin 650mg) and the control group (Moxifloxacin 400mg) were both 88%. The non-inferiority margin was defined as 15%, one-sided significance value was 0.05 (one-tailed α=0.05), power was 80%, and the assignment ratio was 1:1:1.|Odds Ratio (OR)|0.508||||0.445|TWO_SIDED|95.0|0.09|2.883||Only P values less than 0.05 are considered statistically significant in this study.|Regression, Logistic|||||2.883|0.090|0.445
72615537|NCT01944774|144761547|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Clinical success rate was assumed for the experimental group (Nemonoxacin 500mg) and the control group (Moxifloxacin 400mg) were both 88%. The non-inferiority margin was defined as 15%, one-sided significance value was 0.05 (one-tailed α=0.05), power was 80%, and the assignment ratio was 1:1:1.|Odds Ratio (OR)|0.518||||0.458|TWO_SIDED|95.0|0.091|2.941||Only P values less than 0.05 are considered statistically significant in this study.|Regression, Logistic|||||2.941|0.091|0.458
72615538|NCT01944774|144761547|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Clinical success rate was assumed for the experimental group (Nemonoxacin 650mg) and the control group (Moxifloxacin 400mg) were both 88%. The non-inferiority margin was defined as 15%, one-sided significance value was 0.05 (one-tailed α=0.05), power was 80%, and the assignment ratio was 1:1:1.|Odds Ratio (OR)|0.667||||0.664|TWO_SIDED|95.0|0.107|4.144||Only P values less than 0.05 are considered statistically significant in this study.|Regression, Logistic|||||4.144|0.107|0.664
72615539|NCT01944774|144761548|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.0||||0.959|TWO_SIDED|||||Only P values less than 0.05 are considered statistically significant in this study.|Regression, Logistic||The 2-sided 95% confidence interval of OR is (\<0.001, \>999.999).|||||0.959
72615540|NCT01944774|144761548|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.0||||0.961|TWO_SIDED|||||Only P values less than 0.05 are considered statistically significant in this study.|Regression, Logistic||The 2-sided 95% confidence interval of OR is (\<0.001, \>999.999).|||||0.961
72615541|NCT01944774|144761549|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.0||||0.96|TWO_SIDED|||||Only P values less than 0.05 are considered statistically significant in this study.|Regression, Logistic||The 2-sided 95% confidence interval of OR is (\<0.001, \>999.999).|||||0.960
72432088|NCT00797225|144376622|SUPERIORITY||LS Mean Difference|-0.52|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-0.76|-0.29|||Mixed-effects Repeated Measures Model|||Analysis at Week 12. The change from baseline in monthly mean dysmenorrhea scores was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.||-0.29|-0.76|< 0.0001
72554912|NCT05152576|144641719|SUPERIORITY||Rate Difference|41.4|||<|0.001|TWO_SIDED|95.0|23.5|59.3||Based on CMH test stratified by baseline investigator-rated FWS-FHL at maximum.|Cochran-Mantel-Haenszel|||Confidence interval for responder rate is calculated using normal approximation.||59.3|23.5|<0.001
72615542|NCT01944774|144761549|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.0||||0.962|TWO_SIDED|||||Only P values less than 0.05 are considered statistically significant in this study.|Regression, Logistic||The 2-sided 95% confidence interval of OR is (\<0.001, \>999.999).|||||0.962
72615543|NCT01944774|144761550|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.0||||0.95|TWO_SIDED|||||Only P values less than 0.05 are considered statistically significant in this study.|Regression, Logistic||The 2-sided 95% confidence interval of OR is (\<0.001, \>999.999).|||||0.950
72615544|NCT01944774|144761550|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.0||||0.962|TWO_SIDED|||||Only P values less than 0.05 are considered statistically significant in this study.|Regression, Logistic||The 2-sided 95% confidence interval of OR is (\<0.001, \>999.999).|||||0.962
72615545|NCT01944774|144761551|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.0||||0.949|TWO_SIDED|||||Only P values less than 0.05 are considered statistically significant in this study.|Regression, Logistic||The 2-sided 95% confidence interval of OR is (\<0.001, \>999.999).|||||0.949
72615546|NCT01944774|144761551|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.0||||0.962|TWO_SIDED|||||Only P values less than 0.05 are considered statistically significant in this study.|Regression, Logistic||The 2-sided 95% confidence interval of OR is (\<0.001, \>999.999).|||||0.962
72615547|NCT01944774|144761552|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.438||||0.491|TWO_SIDED|95.0|0.042|4.609||Only P values less than 0.05 are considered statistically significant in this study.|Regression, Logistic|||||4.609|0.042|0.491
72615548|NCT01944774|144761552|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.531||||0.619|TWO_SIDED|95.0|0.044|6.444||Only P values less than 0.05 are considered statistically significant in this study.|Regression, Logistic|||||6.444|0.044|0.619
72615549|NCT01944774|144761553|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.444||||0.501|TWO_SIDED|95.0|0.042|4.708||Only P values less than 0.05 are considered statistically significant in this study.|Regression, Logistic|||||4.708|0.042|0.501
72615550|NCT01944774|144761553|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.567||||0.656|TWO_SIDED|95.0|0.047|6.895||Only P values less than 0.05 are considered statistically significant in this study.|Regression, Logistic|||||6.895|0.047|0.656
72615551|NCT01944774|144761554|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.733||||0.807|TWO_SIDED|95.0|0.061|8.832||Only P values less than 0.05 are considered statistically significant in this study.|Regression, Logistic|||||8.832|0.061|0.807
72615552|NCT01944774|144761554|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.567||||0.656|TWO_SIDED|95.0|0.047|6.895||Only P values less than 0.05 are considered statistically significant in this study.|Regression, Logistic|||||6.895|0.047|0.656
72615553|NCT01944774|144761555|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.7||||0.779|TWO_SIDED|95.0|0.058|8.445||Only P values less than 0.05 are considered statistically significant in this study.|Regression, Logistic|||||8.445|0.058|0.779
72615554|NCT01944774|144761555|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.567||||0.656|TWO_SIDED|95.0|0.047|6.895||Only P values less than 0.05 are considered statistically significant in this study.|Regression, Logistic|||||6.895|0.047|0.656
72615555|NCT01179516|144761576|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.79|STANDARD_ERROR_OF_MEAN|1.488||0.597|TWO_SIDED|95.0|-3.71|2.14||Pre-specified sequential statistical testing procedure indicates that when p-value \>0.025, hierarchical testing stops and for subsequent endpoints in the sequence a nominal p-value is provided.|Mixed model for repeated measurements|MMRM ANCOVA with treatment, center, week, treatment-by-week interaction, baseline MADRS total score-by-week as fixed effects.||All statistical tests were 2-sided with the estimated P-values at the 5% level of significance. To control for multiplicity, a pre-specified sequential testing procedure for each dose was applied to compare 10 mg and 15 mg vortioxetine to placebo. Efficacy endpoints were tested for each dose in sequential order at significance level 0.025; as soon as an endpoint was non-significant at 0.025, the testing procedure stopped for all subsequent endpoints.||2.14|-3.71|0.597
72615556|NCT01179516|144761576|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.49|STANDARD_ERROR_OF_MEAN|1.501||0.745|TWO_SIDED|95.0|-3.44|2.46||Pre-specified sequential statistical testing procedure indicates that when p-value \>0.025, hierarchical testing stops and for subsequent endpoints in the sequence a nominal p-value is provided.|Mixed model for repeated measurements|MMRM ANCOVA with treatment, center, week, treatment-by-week interaction, baseline MADRS total score-by-week as fixed effects.||||2.46|-3.44|0.745
72615557|NCT01179516|144761577|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.232||||0.396|TWO_SIDED|95.0|0.761|1.995|||Regression, Logistic|Logistic regression with explanatory variables for treatment and Baseline MADRS score.||||1.995|0.761|0.396
72615558|NCT01179516|144761577|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.212||||0.435|TWO_SIDED|95.0|0.748|1.963|||Regression, Logistic|Logistic regression with explanatory variables for treatment and Baseline MADRS score.||||1.963|0.748|0.435
72615559|NCT01179516|144761578|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.149||0.554|TWO_SIDED|95.0|-0.38|0.21|||Mixed model for repeated measurements|MMRM ANCOVA with treatment, center, week, treatment-by-week interaction, baseline CGI-S score-by-week as fixed effects.||||0.21|-0.38|0.554
72615560|NCT01179516|144761578|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.151||0.739|TWO_SIDED|95.0|-0.35|0.25|||Mixed model for repeated measurements|MMRM ANCOVA with treatment, center, week, treatment-by-week interaction, baseline CGI-S score-by-week as fixed effects.||||0.25|-0.35|0.739
72615561|NCT01179516|144761579|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.97|STANDARD_ERROR_OF_MEAN|2.261||0.67|TWO_SIDED|95.0|-5.43|3.5|||Mixed model for repeated measurements|MMRM ANCOVA with treatment, center, week, treatment-by-week interaction, baseline MADRS total score-by-week as fixed effects.||||3.50|-5.43|0.670
72615562|NCT01179516|144761579|SUPERIORITY_OR_OTHER||LS Mean Difference|1.73|STANDARD_ERROR_OF_MEAN|2.295||0.451|TWO_SIDED|95.0|-2.8|6.26|||Mixed model for repeated measurements|MMRM ANCOVA with treatment, center, week, treatment-by-week interaction, baseline MADRS total score-by-week as fixed effects.||||6.26|-2.80|0.451
72615563|NCT01179516|144761580|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.291||||0.352|TWO_SIDED|95.0|0.754|2.211|||Regression, Logistic|Logistic regression with explanatory variables for treatment and Baseline MADRS total score.||||2.211|0.754|0.352
72432089|NCT00797225|144376622|SUPERIORITY||LS Mean Difference|-0.79|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-1.02|-0.56|||Mixed-effects Repeated Measures Model|||Analysis at Week 12. The change from baseline in monthly mean dysmenorrhea scores was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.||-0.56|-1.02|< 0.0001
72432090|NCT00797225|144376623|SUPERIORITY||LS Mean Difference|-0.32|STANDARD_ERROR_OF_MEAN|0.1||0.0011|TWO_SIDED|95.0|-0.51|-0.13|||Mixed-effects Repeated Measures Model|||Analysis at Week 4. The change from baseline in monthly mean sum of dysmenorrhea and non-menstrual pelvic pain scores was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.||-0.13|-0.51|0.0011
72615564|NCT01179516|144761580|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.116||||0.694|TWO_SIDED|95.0|0.646|1.928|||Regression, Logistic|Logistic regression with explanatory variables for treatment and Baseline MADRS total score.||||1.928|0.646|0.694
72615565|NCT01179516|144761581|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.92|STANDARD_ERROR_OF_MEAN|1.25||0.464|TWO_SIDED|95.0|-3.38|1.55|||Mixed model for repeated measurements|MMRM ANCOVA with treatment, center, week, treatment-by-week interaction, baseline SDS total score-by-week as fixed effects.||||1.55|-3.38|0.464
72615566|NCT01179516|144761581|SUPERIORITY_OR_OTHER||LS Mean Difference|0.69|STANDARD_ERROR_OF_MEAN|1.322||0.6|TWO_SIDED|95.0|-1.91|3.3|||Mixed model for repeated measurements|MMRM ANCOVA with treatment, center, week, treatment-by-week interaction, baseline SDS total score-by-week as fixed effects.||||3.30|-1.91|0.600
72615567|NCT05073315|144761588|EQUIVALENCE|The prespecified similarity margin was 0.8 to 1.25.|Ratio Geometric Least Square Mean (GMR)|1.0516|||||TWO_SIDED|90.0|0.901|1.2273||||||||1.2273|0.9010|
72615568|NCT05073315|144761589|EQUIVALENCE|The prespecified similarity margin was 0.8 to 1.25.|Least Square Mean Ratio|1.0044|||||TWO_SIDED|90.0|0.8717|1.1574||||||||1.1574|0.8717|
72615569|NCT05073315|144761592|EQUIVALENCE|The prespecified similarity margin was 0.8 to 1.25.|Mean Difference (Final Values)|-2.47|||||TWO_SIDED|90.0|-5.23|0.29||||||||0.29|-5.23|
72615570|NCT01529268|144761599|SUPERIORITY|Relative risks and p-values were calculated with the Cochran-Mantel-Haenszel chi-square tests, stratified by clinic and weight group, for binary outcomes.|Risk Ratio (RR)|1.3||||0.34|TWO_SIDED|95.0|0.8|2.1|||Cochran-Mantel-Haenszel|||||2.1|0.8|0.34
72615571|NCT01529268|144761600|SUPERIORITY|P-values and mean changes from baseline were calculated using ANCOVA, regressing change from baseline to 52 weeks on treatment group and baseline value of the outcome, for outcome scores.|Mean Difference (Net)|0.0||||0.9|TWO_SIDED|95.0|-0.6|0.5|||ANCOVA|||||0.5|-0.6|0.90
72615572|NCT01529268|144761601|SUPERIORITY|Relative risks and p-values were calculated with the Cochran-Mantel-Haenszel chi-square tests, stratified by clinic and weight group, for binary outcomes.|Risk Ratio (RR)|0.7||||0.15|TWO_SIDED|95.0|0.5|1.1|||Cochran-Mantel-Haenszel|||Steatosis: patients with improvement||1.1|0.5|0.15
72615573|NCT01529268|144761602|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|P-values and mean changes from baseline were calculated using ANCOVA, regressing change from baseline to 52 weeks on treatment group and baseline value of the outcome, for outcome scores.|Mean Difference (Net)|0.1||||0.59|TWO_SIDED|95.0|-0.2|0.4|||ANCOVA|||Steatosis: change in score||0.4|-0.2|0.59
72615574|NCT01529268|144761603|SUPERIORITY|Relative risks and p-values were calculated with the Cochran-Mantel-Haenszel chi-square tests, stratified by clinic and weight group, for binary outcomes.|Risk Ratio (RR)|1.8||||0.03|TWO_SIDED|95.0|1.1|2.9|||Cochran-Mantel-Haenszel|||||2.9|1.1|0.03
72615575|NCT01529268|144761604|SUPERIORITY|P-values and mean changes from baseline were calculated using ANCOVA, regressing change from baseline to 52 weeks on treatment group and baseline value of the outcome, for outcome scores.|Mean Difference (Net)|-0.2||||0.06|TWO_SIDED|95.0|-0.4|0.0|||ANCOVA|||||0.0|-0.4|0.06
72615576|NCT01529268|144761605|SUPERIORITY|Relative risks and p-values were calculated with the Cochran-Mantel-Haenszel chi-square tests, stratified by clinic and weight group, for binary outcomes.|Risk Ratio (RR)|0.8||||0.29|TWO_SIDED|95.0|0.4|1.3|||Cochran-Mantel-Haenszel|||||1.3|0.4|0.29
72615577|NCT01529268|144761606|SUPERIORITY|P-values and mean changes from baseline were calculated using ANCOVA, regressing change from baseline to 52 weeks on treatment group and baseline value of the outcome, for outcome scores.|Mean Difference (Net)|0.1||||0.15|TWO_SIDED|95.0|-0.1|0.3|||ANCOVA|||||0.3|-0.1|0.15
72615578|NCT01529268|144761607|SUPERIORITY|Relative risks and p-values were calculated with the Cochran-Mantel-Haenszel chi-square tests, stratified by clinic and weight group, for binary outcomes.|Risk Ratio (RR)|1.2||||0.57|TWO_SIDED|95.0|0.6|2.3|||Cochran-Mantel-Haenszel|||||2.3|0.6|0.57
72615579|NCT01529268|144761608|SUPERIORITY|P-values and mean changes from baseline were calculated using ANCOVA, regressing change from baseline to 52 weeks on treatment group and baseline value of the outcome, for outcome scores.|Mean Difference (Net)|0.0||||0.76|TWO_SIDED|95.0|-0.2|0.2|||ANCOVA|||||0.2|-0.2|0.76
72615580|NCT01529268|144761609|SUPERIORITY|Relative risks and p-values were calculated with the Cochran-Mantel-Haenszel chi-square tests, stratified by clinic and weight group, for binary outcomes.|Risk Ratio (RR)|1.0||||0.98|TWO_SIDED|95.0|0.6|1.6|||Cochran-Mantel-Haenszel|||||1.6|0.6|0.98
72615581|NCT01529268|144761610|SUPERIORITY|P-values and mean changes from baseline were calculated using ANCOVA, regressing change from baseline to 52 weeks on treatment group and baseline value of the outcome, for outcome scores.|Mean Difference (Net)|-0.2||||0.24|TWO_SIDED|95.0|-0.4|0.1|||ANCOVA|||||0.1|-0.4|0.24
72615582|NCT01529268|144761611|NON_INFERIORITY|Relative risks and p-values were calculated with the Cochran-Mantel-Haenszel chi-square tests, stratified by clinic and weight group, for binary outcomes.|Risk Ratio (RR)|2.7||||0.29|TWO_SIDED|95.0|0.4|18.3|||Cochran-Mantel-Haenszel|Stratified by clinic and weight group||||18.3|0.4|0.29
72615583|NCT01529268|144761612|SUPERIORITY|P-value and difference in mean changes from baseline were calculated using ANCOVA models, regressing change from baseline to 52 weeks in serum alanine aminotransferase on treatment group and baseline value of serum alanine aminotransferase.|Adjusted difference in mean changes|-24.0||||0.02|TWO_SIDED|95.0|-44.0|-4.0|||ANCOVA|Adjusted for baseline serum alanine aminotransferase||Adjusted difference in mean changes in serum alanine aminotransferase (ALT). The change in ALT is adjusted for the baseline ALT value; therefore, the adjusted difference in mean changes is not equal to the net change.||-4|-44|0.02
72615584|NCT01529268|144761612|SUPERIORITY|P-value and difference in mean changes from baseline were calculated using ANCOVA models, regressing changes from baseline to 52 weeks in serum aspartate aminotransferase on treatment group and baseline value of serum aspartate aminotransferase.|Mean Difference (Net)|-15.0||||0.008|TWO_SIDED|95.0|-26.0|-4.0|||ANCOVA|Adjusted for baseline serum aspartate aminotransferase.||Adjusted difference in mean changes in serum aspartate aminotransferase (AST). The change in AST is adjusted for the baseline AST value; therefore, the adjusted difference in mean changes is not equal to the net change.||-4|-26|0.008
72615585|NCT01529268|144761612|SUPERIORITY|P-value and difference in mean changes from baseline were calculated using ANCOVA models, regressing changes from baseline to 52 weeks in gamma-glutamyl transpeptidase on treatment group and baseline value of gamma-glutamyl transpeptidase.|Mean Difference (Net)|-7.0||||0.02|TWO_SIDED|95.0|-13.0|-1.0|||ANCOVA|Adjusted for baseline gamma-glutamyl transpeptidase||Adjusted difference in mean changes in serum gamma-glutamyl transpeptidase (GGT). The change in GGT is adjusted for the baseline GGTvalue; therefore, the adjusted difference in mean changes is not equal to the net change.||-1|-13|0.02
72615586|NCT01529268|144761613|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|P-value and adjusted difference in mean changes from baseline were calculated using ANCOVA models, regressing changes from baseline to 52 weeks in weight (kg) on treatment group and baseline weight (kg).|Adjusted difference in mean changes|-1.5||||0.25|TWO_SIDED|95.0|-4.1|1.1|||ANCOVA|Adjusted for baseline weight (kg).||Adjusted difference in mean changes in weight (kg). The change in weight is adjusted for the baseline weight value; therefore, the adjusted difference in mean changes is not equal to the net change.||1.1|-4.1|0.25
72615587|NCT01529268|144761614|SUPERIORITY|P-values and differences in mean changes from baseline were calculated using ANCOVA models, regressing changes from baseline to 52 weeks on treatment group and baseline value of the outcome.|Adjusted difference in mean changes|-0.3||||0.42|TWO_SIDED|95.0|-1.1|0.5|||ANCOVA|Adjusted for baseline BMI (kg/m2)||Adjusted difference in mean changes in body mass index (BMI). The change in BMI is adjusted for the baseline BMI value; therefore, the adjusted difference in mean changes is not equal to the net change.||0.5|-1.1|0.42
72615588|NCT01529268|144761615|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|P-values and differences in mean changes from baseline were calculated using ANCOVA models, regressing changes from baseline to 52 weeks on treatment group and baseline value of the outcome.|Mean Difference (Net)|-0.1||||0.11|TWO_SIDED|95.0|-0.1|0.0|||ANCOVA|||||0.0|-0.1|0.11
72615589|NCT01529268|144761616|SUPERIORITY|P-values and differences in mean changes from baseline were calculated using ANCOVA models, regressing changes from baseline to 52 weeks in waist circumference on treatment group and baseline value of waist circumference.|Adjusted difference in mean changes|0.2||||0.89|TWO_SIDED|95.0|-2.3|2.6|||ANCOVA|Adjusted for baseline waist circumference (cm)||Adjusted difference in mean changes in waist circumference (cm). The change in waist circumference is adjusted for the baseline waist circumference value; therefore, the adjusted difference in mean changes is not equal to the net change.||2.6|-2.3|0.89
72615590|NCT01529268|144761617|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|P-values and differences in mean changes from baseline were calculated using ANCOVA models, regressing changes from baseline to 52 weeks in fasting serum glucose on treatment group and baseline fasting serum glucose value.|Adjusted difference in mean changes|-4.0||||0.24|TWO_SIDED|95.0|-11.0|3.0|||ANCOVA|Adjusted for baseline serum glucose value.||Adjusted difference in mean changes in fasting serum glucose. The change in fasting serum glucose is adjusted for the baseline fasting serum glucose value; therefore, the adjusted difference in mean changes is not equal to the net change.||3|-11|0.24
72615591|NCT01529268|144761618|SUPERIORITY|P-value and difference in mean changes from baseline were calculated using ANCOVA models, regressing changes from baseline to 52 weeks in fasting insulin on treatment group and baseline fasting insulin.|Adjusted difference in mean changes|-6.0||||0.34|TWO_SIDED|95.0|-18.0|6.0|||ANCOVA|Adjusted for baseline fasting insulin.||Adjusted difference in mean changes in fasting insulin. The change in fasting insulin is adjusted for the baseline fasting insulin value; therefore, the adjusted difference in mean changes is not equal to the net change.||6|-18|0.34
72615592|NCT01529268|144761619|SUPERIORITY|P-values and differences in mean changes from baseline were calculated using ANCOVA models, regressing changes from baseline to 52 weeks in HOMA-IR on treatment group and baseline HOMA-IR value.|Adjusted difference in mean changes|-2.6||||0.15|TWO_SIDED|95.0|-6.2|1.0|||ANCOVA|Adjusted for baseline HOMA-IR.||Adjusted difference in mean changes in HOMA-IR. The change in HOMA-IR is adjusted for the baseline HOMA-IR value; therefore, the adjusted difference in mean changes is not equal to the net change.||1.0|-6.2|0.15
72615593|NCT01529268|144761620|SUPERIORITY|P-values and differences in mean changes from baseline were calculated using ANCOVA models, regressing changes from baseline to 52 weeks in systolic blood pressure on treatment group and baseline systolic blood pressure value.|Adjusted difference in mean changes|1.0||||0.71|TWO_SIDED|95.0|-3.0|4.0|||ANCOVA|Adjusted for baseline systolic blood pressure.||Adjusted difference in mean changes in systolic blood pressure. The change in systolic blood pressure is adjusted for the baseline systolic blood pressure value; therefore, the adjusted difference in mean changes is not equal to the net change.||4|-3|0.71
72615594|NCT01529268|144761621|SUPERIORITY|P-values and differences in mean changes from baseline were calculated using ANCOVA models, regressing changes from baseline to 52 weeks in diastolic blood pressure on treatment group and baseline diastolic blood pressure value.|Adjusted difference in mean changes|-1.0||||0.31|TWO_SIDED|95.0|-4.0|1.0|||ANCOVA|Adjusted for baseline diastolic blood pressure.||Adjusted difference in mean changes in diastolic blood pressure. The change in diastolic blood pressure is adjusted for the baseline diastolic blood pressure value; therefore, the adjusted difference in mean changes is not equal to the net change.||1|-4|0.31
72615595|NCT01529268|144761622|SUPERIORITY|P-value and difference in mean changes from baseline were calculated using ANCOVA models, regressing changes from baseline to 52 weeks in self-reported Physical Health summary score on treatment group and baseline value of the Physical Health summary score.|Adjusted difference in mean changes|-1.0||||0.77|TWO_SIDED|95.0|-5.0|3.0|||ANCOVA|Adjusted for baseline self-reported Physical Health summary score.||Adjusted difference in mean changes from baseline in self-reported Physical Health summary score from the Pediatric Quality of Life Inventory (PedsQL). The difference in mean changes in Physical Health summary score is adjusted for the baseline Physical Health summary score; therefore, the adjusted difference in mean changes is not equal to the net change. Higher scores indicate better health-related quality of life.||3|-5|0.77
72615596|NCT01529268|144761622|SUPERIORITY|P-value and difference in mean changes from baseline were calculated using ANCOVA models, regressing changes from baseline to 52 weeks in Pyschosocial Health summary score on treatment group and baseline Psychosocial Health summary score.|Adjusted difference in mean changes|-1.0||||0.64|TWO_SIDED|95.0|-5.0|3.0|||ANCOVA|Adjusted for baseline Psychosocial Health summary score.||Adjusted difference in mean changes from baseline in self-reported Psychosocial Health summary score from the Pediatric Quality of Life Inventory (PedsQL). The difference in mean changes in Psychosocial Health summary score is adjusted for the baseline Psychosocial Health summary score; therefore, the adjusted difference in mean changes is not equal to the net change. Higher scores indicate better health-related quality of life.||3|-5|0.64
72615597|NCT01529268|144761622|SUPERIORITY|P-value and difference in mean changes from baseline were calculated using ANCOVA models, regressing changes from baseline to 52 weeks in parent/guardian-reported Physical Health summary score on treatment group and baseline value of the parent/guardian-reported Physical Health summary score.|Adjusted difference in mean changes|-2.0||||0.58|TWO_SIDED|95.0|-9.0|5.0|||ANCOVA|Adjusted for baseline parent/guardian-reported Physical Health summary score.||Adjusted difference in mean changes from baseline in parent/guardian-reported Physical Health summary score from the Pediatric Quality of Life Inventory (PedsQL). The difference in mean changes in parent/guardian-reported Physical Health summary score is adjusted for the baseline parent/guardian-reported Physical Health summary score; therefore, the adjusted difference in mean changes is not equal to the net change. Higher scores indicate better health-related quality of life.||5|-9|0.58
72622171|NCT03382873|144774353|SUPERIORITY|||||||0.2063|||||||ANOVA|Intervention sequence and sex used as independent predictors in the model.||Comparison between the GLB/GLB intervention sequence and the GLB+/GLB+ intervention sequence (the primary comparison of interest)||||0.2063
72554913|NCT04278560|144641731|SUPERIORITY||Mean Difference (Net)|385.3||||0.009|TWO_SIDED|||||Repeated Measures Two-Way ANOVA: Group, Time, Group x Time, and controlled by Baseline Step Counts|ANOVA|||||||0.009
72615598|NCT01529268|144761622|SUPERIORITY|P-value and difference in mean changes from baseline were calculated using ANCOVA models, regressing changes from baseline to 52 weeks in parent/guardian-reported Psychosocial Health summary score on treatment group and baseline value of the parent/guardian-reported Psychosocial Health summary score.|Adjusted difference in mean changes|-1.0||||0.85|TWO_SIDED|95.0|-6.0|5.0|||ANCOVA|||Adjusted difference in mean changes from baseline in parent/guardian-reported Psychosocial Health summary score from the Pediatric Quality of Life Inventory (PedsQL). The difference in mean changes in parent/guardian-reported Psychosocial Health summary score is adjusted for the baseline parent/guardian-reported Psychosocial Health summary score; therefore, the adjusted difference in mean changes is not equal to the net change. Higher scores indicate better health-related quality of life.||5|-6|0.85
72615599|NCT01529268|144761623|SUPERIORITY||Mean Difference (Final Values)|-2.7||||0.11|TWO_SIDED||||||ANCOVA|||||||0.11
72615600|NCT03491917|144761640|NON_INFERIORITY|Non-inferiority margin is delta = 0.05.|||||<|0.01||||||The average difference in AUC was 0.023 (two-sided 95% CI: -0.012, 0.059; non-inferiority p \< 0.01 for non-inferiority margin delta = -0.05).|t-test, 2 sided|df: 417.0 for FFDM, 424.6 for DBT plus S-View, and (1, 18.9) for the difference.||The primary endpoint for this study was a non-inferior per-subject average area under the receiver operating characteristic (ROC) curve (AUC) requiring correct lesion localization for DBT (digital breast tomosynthesis) plus S-View (synthesized view) versus FFDM (full field digital mammography). AUCs for each reader were estimated in each review condition based on per-subject probability of malignancy (POM) scores requiring correct lesion localization.||||<0.01
72615601|NCT01068912|144761647|SUPERIORITY_OR_OTHER|||||||0.05|TWO_SIDED|||||A step-down approach was applied to the primary analysis, with the higher dose of favipiravir first tested against placebo.|Gehan-Wilcoxon|||Time required from first study drug administration to alleviation of the 6 primary influenza symptoms and fever. The primary influenza symptoms included cough, sore throat, headache, nasal congestion, body aches and pains, and fatigue. Symptoms were considered alleviated when all were decreased to ≤1 and decrease persisted unchanged ≥ 21.5 hours. Fever was considered alleviated when maintained at \< 38.0°C (age 20 to \< 65 years) or \< 37.8°C (age ≥ 65 years) ≥ 21.5 hours.||||.05
72615602|NCT05537571|144761649|SUPERIORITY||Mean Difference (Final Values)|-82.8|||<|0.0001|TWO_SIDED|95.0|-88.19|-77.39|||ANOVA|||Analysis of variance (ANOVA) was used to test for differences between each active treatment group and the pooled placebo groups in the primary outcome measure.||-77.39|-88.19|<0.0001
72615603|NCT05537571|144761649|SUPERIORITY||Mean Difference (Final Values)|-81.3|||<|0.0001|TWO_SIDED|95.0|-86.68|-76.0|||ANOVA|||Analysis of variance (ANOVA) was used to test for differences between each active treatment group and the pooled placebo groups in the primary outcome measure.||-76.0|-86.68|<0.0001
72615604|NCT05537571|144761649|SUPERIORITY||Mean Difference (Final Values)|-85.6|||<|0.0001|TWO_SIDED|95.0|-90.88|-80.26|||ANOVA|||Analysis of variance (ANOVA) was used to test for differences between each active treatment group and the pooled placebo groups in the primary outcome measure.||-80.26|-90.88|<0.0001
72615605|NCT05537571|144761650|SUPERIORITY||Mean Difference (Final Values)|-83.1|||<|0.0001|TWO_SIDED|95.0|-88.7|-77.57|||ANOVA|||Analysis of variance (ANOVA) was used to test for differences between each active treatment group and the pooled placebo groups in the primary outcome measure.||-77.57|-88.7|<0.0001
72615606|NCT05537571|144761650|SUPERIORITY||Mean Difference (Final Values)|-78.7|||<|0.0001|TWO_SIDED|95.0|-84.18|-73.17|||ANOVA|||Analysis of variance (ANOVA) was used to test for differences between each active treatment group and the pooled placebo groups in the primary outcome measure.||-73.17|-84.18|<0.0001
72615607|NCT05537571|144761650|SUPERIORITY||Mean Difference (Final Values)|-83.0|||<|0.0001|TWO_SIDED|95.0|-88.43|-77.49|||ANOVA|||Analysis of variance (ANOVA) was used to test for differences between each active treatment group and the pooled placebo groups in the primary outcome measure.||-77.49|-88.43|<0.0001
72615608|NCT05537571|144761651|SUPERIORITY||Mean Difference (Final Values)|-79.2|||<|0.0001|TWO_SIDED|95.0|-85.25|-73.1|||ANOVA|||Analysis of variance (ANOVA) was used to test for differences between each active treatment group and the pooled placebo groups in the primary outcome measure.||-73.1|-85.25|<0.0001
72615609|NCT05537571|144761651|SUPERIORITY||Mean Difference (Final Values)|-71.8|||<|0.0001|TWO_SIDED|95.0|-77.81|-65.8|||ANOVA|||Analysis of variance (ANOVA) was used to test for differences between each active treatment group and the pooled placebo groups in the primary outcome measure.||-65.8|-77.81|<0.0001
72615610|NCT05537571|144761651|SUPERIORITY||Mean Difference (Final Values)|-77.1|||<|0.0001|TWO_SIDED|95.0|-83.09|-71.15|||ANOVA|||Analysis of variance (ANOVA) was used to test for differences between each active treatment group and the pooled placebo groups in the primary outcome measure.||-71.15|-83.09|<0.0001
72615611|NCT05537571|144761652|SUPERIORITY||Mean Difference (Final Values)|-13.3|||<|0.0001|TWO_SIDED|95.0|-18.55|-8.09|||ANOVA|||Analysis of variance (ANOVA) was used to test for differences between each active treatment group and the pooled placebo groups in the primary outcome measure.||-8.09|-18.55|<0.0001
72615612|NCT05537571|144761652|SUPERIORITY||Mean Difference (Final Values)|-9.9|||=|0.0002|TWO_SIDED|95.0|-15.02|-4.68|||ANOVA|||Analysis of variance (ANOVA) was used to test for differences between each active treatment group and the pooled placebo groups in the primary outcome measure.||-4.68|-15.02|=0.0002
72615613|NCT05537571|144761652|SUPERIORITY||Mean Difference (Final Values)|-15.0|||<|0.0001|TWO_SIDED|95.0|-20.1|-9.82|||ANOVA|||Analysis of variance (ANOVA) was used to test for differences between each active treatment group and the pooled placebo groups in the primary outcome measure.||-9.82|-20.1|<0.0001
72615614|NCT05537571|144761653|SUPERIORITY||Mean Difference (Final Values)|-12.3|||<|0.0001|TWO_SIDED|95.0|-17.62|-7.08|||ANOVA|||Analysis of variance (ANOVA) was used to test for differences between each active treatment group and the pooled placebo groups in the primary outcome measure.||-7.08|-17.62|<0.0001
72615615|NCT05537571|144761653|SUPERIORITY||Mean Difference (Final Values)|-8.6|||=|0.0013|TWO_SIDED|95.0|-13.85|-3.44|||ANOVA|||Analysis of variance (ANOVA) was used to test for differences between each active treatment group and the pooled placebo groups in the primary outcome measure.||-3.44|-13.85|=0.0013
72615616|NCT05537571|144761653|SUPERIORITY||Mean Difference (Final Values)|-14.0|||<|0.0001|TWO_SIDED|95.0|-19.2|-8.84|||ANOVA|||Analysis of variance (ANOVA) was used to test for differences between each active treatment group and the pooled placebo groups in the primary outcome measure.||-8.84|-19.2|<0.0001
72615617|NCT05537571|144761654|SUPERIORITY||Mean Difference (Final Values)|-11.3|||<|0.0001|TWO_SIDED|95.0|-16.81|-5.73|||ANOVA|||Analysis of variance (ANOVA) was used to test for differences between each active treatment group and the pooled placebo groups in the primary outcome measure.||-5.73|-16.81|<0.0001
72615618|NCT05537571|144761654|SUPERIORITY||Mean Difference (Final Values)|-7.2|||=|0.0106|TWO_SIDED|95.0|-12.64|-1.69|||ANOVA|||Analysis of variance (ANOVA) was used to test for differences between each active treatment group and the pooled placebo groups in the primary outcome measure.||-1.69|-12.64|=0.0106
72615619|NCT05537571|144761654|SUPERIORITY||Mean Difference (Final Values)|-12.6|||<|0.0001|TWO_SIDED|95.0|-18.04|-7.15|||ANOVA|||Analysis of variance (ANOVA) was used to test for differences between each active treatment group and the pooled placebo groups in the primary outcome measure.||-7.15|-18.04|<0.0001
72615620|NCT05537571|144761655|SUPERIORITY||Mean Difference (Final Values)|-31.9|||=|0.0051|TWO_SIDED|95.0|-54.07|-9.72|||ANOVA|||Analysis of variance (ANOVA) was used to test for differences between each active treatment group and the pooled placebo groups in the primary outcome measure.||-9.72|-54.07|=0.0051
72615621|NCT05537571|144761655|SUPERIORITY||Mean Difference (Final Values)|-29.7|||=|0.0081|TWO_SIDED|95.0|-51.62|-7.81|||ANOVA|||Analysis of variance (ANOVA) was used to test for differences between each active treatment group and the pooled placebo groups in the primary outcome measure.||-7.81|-51.62|=0.0081
72504978|NCT01462292|144541161|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.49||||0.684|TWO_SIDED|95.0|-2.9|1.92||No adjustment for multiplicity was made, so p-values should not be used to make conclusions with regards to statistical significance|ANCOVA|Model included terms for treatment, center grouping and baseline||Treatment difference: Placebo Vs GSK2402968 3 mg||1.92|-2.90|0.684
72615622|NCT05537571|144761655|SUPERIORITY||Mean Difference (Final Values)|-25.1|||=|0.0241|TWO_SIDED|95.0|-46.89|-3.33|||ANOVA|||Analysis of variance (ANOVA) was used to test for differences between each active treatment group and the pooled placebo groups in the primary outcome measure.||-3.33|-46.89|=0.0241
72615623|NCT05537571|144761656|SUPERIORITY||Mean Difference (Final Values)|-29.8|||=|0.0023|TWO_SIDED|95.0|-48.86|-10.76|||ANOVA|||Analysis of variance (ANOVA) was used to test for differences between each active treatment group and the pooled placebo groups in the primary outcome measure.||-10.76|-48.86|=0.0023
72615624|NCT05537571|144761656|SUPERIORITY||Mean Difference (Final Values)|-27.4|||=|0.0046|TWO_SIDED|95.0|-46.23|-8.58|||ANOVA|||Analysis of variance (ANOVA) was used to test for differences between each active treatment group and the pooled placebo groups in the primary outcome measure.||-8.58|-46.23|=0.0046
72615625|NCT05537571|144761656|SUPERIORITY||Mean Difference (Final Values)|-26.0|||=|0.0068|TWO_SIDED|95.0|-44.67|-7.24|||ANOVA|||Analysis of variance (ANOVA) was used to test for differences between each active treatment group and the pooled placebo groups in the primary outcome measure.||-7.24|-44.67|=0.0068
72615626|NCT05537571|144761657|SUPERIORITY||Mean Difference (Final Values)|-28.7|||=|0.0057|TWO_SIDED|95.0|-48.91|-8.46|||ANOVA|||Analysis of variance (ANOVA) was used to test for differences between each active treatment group and the pooled placebo groups in the primary outcome measure.||-8.46|-48.91|=0.0057
72615627|NCT05537571|144761657|SUPERIORITY||Mean Difference (Final Values)|-26.1|||||TWO_SIDED|95.0|-46.13|-6.16||||||Analysis of variance (ANOVA) was used to test for differences between each active treatment group and the pooled placebo groups in the primary outcome measure.||-6.16|-46.13|
72615628|NCT05537571|144761657|SUPERIORITY||Mean Difference (Final Values)|-24.1||||0.0179|TWO_SIDED|95.0|-43.93|-4.2|||ANOVA|||Analysis of variance (ANOVA) was used to test for differences between each active treatment group and the pooled placebo groups in the primary outcome measure.||-4.2|-43.93|0.0179
72615629|NCT00223821|144761672|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.2|STANDARD_ERROR_OF_MEAN|7.65||0.16|TWO_SIDED|95.0|-5.13|25.54|||ANCOVA|ANCOVA, with baseline frequency of incontinent episodes as the covariate, was used to compare the treatment groups.||The effectiveness of each intervention was calculated by comparing the weekly frequency of incontinent episodes (derived from seven-day bladder diaries) during baseline to that in the immediate post-intervention period (week 8). The primary analysis was based on intent-to-treat, in which post-treatment frequency of incontinence for non-completers was derived from the most recent week of diaries.||25.54|-5.13|.16
72615630|NCT00223821|144761673|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.8|STANDARD_ERROR_OF_MEAN|8.71||0.37|TWO_SIDED|95.0|-10.73|24.33|||ANCOVA|ANCOVA, with baseline frequency of incontinent episodes as the covariate, was used to compare the treatment groups.||||24.33|-10.73|.37
72615631|NCT01039675|144761674|NON_INFERIORITY_OR_EQUIVALENCE|UMEC/VI will be declared non-inferior to placebo in terms of weighted mean pulse rate if the upper limit of the 95% confidence interval around the estimated treatment difference for weighted mean pulse rate is less than the non-inferiority margin of +10bpm.|Mean Difference (Final Values)|-0.5|||||TWO_SIDED|95.0|-5.5|4.5|||||Estimated from repeated measures analysis of covariance.|||4.5|-5.5|
72615632|NCT05177094|144761770|SUPERIORITY||Posterior Mean Difference|-0.15|||||TWO_SIDED|95.0|-0.7|0.4|||||Posterior mean difference with 95% credible interval is reported.|||0.40|-0.70|
72615633|NCT05177094|144761771|SUPERIORITY||Posterior Mean Difference|-0.01|||||TWO_SIDED|95.0|-0.66|0.64|||||Posterior mean difference with 95% credible interval is reported.|||0.64|-0.66|
72615634|NCT05177094|144761772|SUPERIORITY||Posterior Mean Difference|-0.13|||||TWO_SIDED|95.0|-0.72|0.46|||||Posterior mean difference with 95% credible interval is reported.|||0.46|-0.72|
72615635|NCT05177094|144761773|SUPERIORITY||Posterior Mean Difference|-0.26|||||TWO_SIDED|95.0|-0.98|0.46|||||Posterior mean difference with 95% credible interval is reported.|||0.46|-0.98|
72615636|NCT05177094|144761774|SUPERIORITY||Posterior Mean Difference|-0.22|||||TWO_SIDED|95.0|-0.61|0.18|||||Posterior mean difference with 95% credible interval is reported.|||0.18|-0.61|
72615637|NCT05177094|144761775|SUPERIORITY||Posterior Mean Difference|-0.17|||||TWO_SIDED|95.0|-0.58|0.24|||||Posterior mean difference with 95% credible interval is reported.|||0.24|-0.58|
72615638|NCT05177094|144761776|SUPERIORITY||Posterior Mean Difference|-0.12|||||TWO_SIDED|95.0|-0.68|0.45|||||Posterior mean difference with 95% credible interval is reported.|||0.45|-0.68|
72615639|NCT05177094|144761777|SUPERIORITY||Posterior Mean Difference|0.06|||||TWO_SIDED|95.0|-0.65|0.77|||||Posterior mean difference with 95% credible interval is reported.|||0.77|-0.65|
72615640|NCT05177094|144761778|SUPERIORITY||Posterior Mean Difference|-3.09|||||TWO_SIDED|95.0|-10.43|4.28|||||Posterior mean difference with 95% credible interval is reported.|||4.28|-10.43|
72615641|NCT05177094|144761779|SUPERIORITY||Posterior Mean Difference|-1.5|||||TWO_SIDED|95.0|-10.04|7.0|||||Posterior mean difference with 95% credible interval is reported.|||7.00|-10.04|
72615642|NCT05177094|144761780|SUPERIORITY||Posterior Mean Difference|0.12|||||TWO_SIDED|95.0|-0.32|0.54|||||Posterior mean difference with 95% credible interval is reported.|||0.54|-0.32|
72615643|NCT05177094|144761781|SUPERIORITY||Posterior Mean Difference|0.2|||||TWO_SIDED|95.0|-0.24|0.65|||||Posterior mean difference with 95% credible interval is reported.|||0.65|-0.24|
72615644|NCT05177094|144761782|SUPERIORITY||Posterior Mean Difference|44.36|||||TWO_SIDED|95.0|-114.73|204.0|||||Posterior mean difference with 95% credible interval is reported.|||204.00|-114.73|
72615645|NCT05177094|144761783|SUPERIORITY||Posterior Mean Difference|-98.76|||||TWO_SIDED|95.0|-231.86|34.49|||||Posterior mean difference with 95% credible interval is reported.|||34.49|-231.86|
72615646|NCT05177094|144761784|SUPERIORITY||Posterior Mean Difference|0.01|||||TWO_SIDED|95.0|-0.05|0.07|||||Posterior mean difference with 95% credible interval is reported.|||0.07|-0.05|
72615647|NCT05177094|144761785|SUPERIORITY||Posterior Mean Difference|-0.01|||||TWO_SIDED|95.0|-0.09|0.08|||||Posterior mean difference with 95% credible interval is reported.|||0.08|-0.09|
72615648|NCT02400736|144761786|SUPERIORITY|"Proportion of steady workers in each group was analyzed using a logistic regression model to calculate an odds ratio and 95% Confidence Interval. Adhering to the principle of intent-to-treat, participants were retained in the arm to which they were randomized for the 12-month follow-up period despite discontinuing the treatment intervention or exiting the study early. Missing data was counted as not worked."|Odds Ratio (OR)|2.49||||0.02|TWO_SIDED|95.0|1.14|5.43||a priori threshold for statistical significance p \</=0.05; not adjusted for multiple comparisons.|Chi-squared|||Using SamplePower 3.0 to estimate the statistical power, the target sample size of 120 (60 per group) provided 84% power to detect a 25% or greater absolute difference between groups in the percent of participants achieving 'steady worker' status (e.g., 40% in IPS vs. 15% in control arm), at the .05 level of significance, assuming a 10% attrition.||5.43|1.14|0.02
72615649|NCT02400736|144761787|SUPERIORITY|Intent to treat analysis.||||||0.003||||||a priori threshold for statistical significance p \</=0.05; not adjusted for multiple comparisons.|t-test, 2 sided|||Total mean time worked was compared using an analysis of variance (ANOVA).||||0.003
72615650|NCT02400736|144761788|SUPERIORITY|||||||0.005||||||a priori threshold for statistical significance p \</=0.05; not adjusted for multiple comparisons.|Mixed Models Analysis|||intent to treat analysis||||0.005
72615651|NCT02400736|144761789|SUPERIORITY|a priori threshold for statistical significance p \</=0.05; not adjusted for multiple comparisons.||||||0.033|||||||t-test, 2 sided|||||||0.033
72615652|NCT02400736|144761790|SUPERIORITY|||||||0.853||||||a priori threshold for statistical significance p \</=0.05; not adjusted for multiple comparisons.|Mixed Models Analysis|Effect of treatment on outcome was analyzed using longitudinal mixed-effects regression model.Group by time interaction tested for treatment effect.||||||0.853
72432091|NCT00797225|144376623|SUPERIORITY||LS Mean Difference|-0.32|STANDARD_ERROR_OF_MEAN|0.1||0.001|TWO_SIDED|95.0|-0.51|-0.13|||Mixed-effects Repeated Measures Model|||Analysis at Week 4. The change from baseline in monthly mean sum of dysmenorrhea and non-menstrual pelvic pain scores was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.||-0.13|-0.51|0.0010
72615653|NCT02400736|144761791|SUPERIORITY|a priori threshold for statistical significance p \</=0.05; not adjusted for multiple comparisons.||||||0.004|||||||t-test, 2 sided|||||||0.004
72615654|NCT02400736|144761792|SUPERIORITY|||||||0.47||||||a priori threshold for statistical significance p \</=0.05; not adjusted for multiple comparisons.|Mixed Models Analysis|Effect of treatment on outcome was analyzed using longitudinal mixed-effects regression model.Group by time interaction tested for treatment effect.||The effect of treatment on each of secondary outcome measures were analyzed using a longitudinal mixed-effects regression model. The group by time interaction tested for the treatment effect.||||0.47
72615655|NCT02400736|144761793|SUPERIORITY|||||||0.062||||||a priori threshold for statistical significance p \</=0.05; not adjusted for multiple comparisons.|t-test, 2 sided|||||||0.062
72432092|NCT00797225|144376623|SUPERIORITY||LS Mean Difference|-0.38|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001|TWO_SIDED|95.0|-0.57|-0.19|||Mixed-effects Repeated Measures Model|||Analysis at Week 4. The change from baseline in monthly mean sum of dysmenorrhea and non-menstrual pelvic pain scores was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.||-0.19|-0.57|< 0.0001
72615656|NCT02400736|144761794|SUPERIORITY||||||>|0.3||||||a priori threshold for statistical significance p \</= 0.05 or lower. No adjustments were made for multiple comparisons.|ANOVA|||||||>0.3
72615657|NCT02400736|144761795|SUPERIORITY|||||||0.001||||||a priori threshold for statistical significance p \</=0.05; not adjusted for multiple comparisons.|t-test, 2 sided|||||||0.001
72615658|NCT02400736|144761796|SUPERIORITY|||||||0.006||||||a priori threshold for statistical significance p \</=0.05; not adjusted for multiple comparisons.|Chi-squared|||||||0.006
72615659|NCT00138294|144761802|OTHER||Incidence Rate Ratio|0.89|||||TWO_SIDED|95.0|0.87|0.91||||||Overall Effectiveness against MAARI during the Epidemic Period (2007-2008)||0.91|0.87|
72615660|NCT00138294|144761803|OTHER||Incidence Rate Ratio|0.69|||||TWO_SIDED|95.0|0.67|0.71||||||Overall Effectiveness against MAARI during the Epidemic Period (2008-2009)||0.71|0.67|
72615661|NCT00138294|144761804|OTHER||Incidence Rate Ratio|0.75|||||TWO_SIDED|95.0|0.73|0.76||||||Overall Effectiveness against MAARI during the Epidemic Period (2008-2009)||0.76|0.73|
72615662|NCT04764539|144761823|SUPERIORITY||Mean Difference (Final Values)|-0.24|STANDARD_DEVIATION|0.294|<|0.555|TWO_SIDED|95.0|-1.276|0.796||Sample size is too small for statistical power.|ANOVA||Difference = (VR goggles group - iPad Pro group)|The Mean Length of Utterance (MLU) will not increase from baseline for the either the iPad Pro or VR goggle participant group after having used the VAST system for 2 months.||0.796|-1.276|<0.555
72615663|NCT04764539|144761823|SUPERIORITY||Mean Difference (Final Values)|0.5383|STANDARD_DEVIATION|0.659|<|0.2128|TWO_SIDED|95.0|-0.471|1.548||Sample size is too small for statistical power.|ANOVA||Difference = (iPad Pro group Post-Treatment - iPad Pro group Pre-Treatment)|Comparison of pre-test and post-test outcome per group.||1.548|-0.471|<0.2128
72615664|NCT04764539|144761823|SUPERIORITY||Mean Difference (Final Values)|0.298|STANDARD_DEVIATION|0.365|<|0.533|TWO_SIDED|95.0|-0.915|1.511||Sample size is too small for statistical power.|ANOVA||Difference = (VR goggles group Post-Treatment - VR goggles group Pre-Treatment)|Comparison of pre-test and post-test outcome per group.||1.511|-0.915|<0.533
72615665|NCT04764539|144761824|SUPERIORITY||Mean Difference (Final Values)|1.388|STANDARD_DEVIATION|1.7|<|0.289|TWO_SIDED|95.0|-1.763|4.539||Sample size too small for statistical power. In addition, automated speech recognition for child speech had a very poor state-of-the-art at the time of this study.|ANOVA||Difference = (iPad Pro group - VR goggles group)|The percentage of correctly transcribed words using automatic speech recognition will not increase from baseline for the either the iPad Pro or VR goggle participant group after having used the VAST system for 2 months.||4.539|-1.763|<0.289
72615666|NCT04764539|144761825|SUPERIORITY||Mean Difference (Final Values)|-3.51|STANDARD_DEVIATION|4.3||0.4296|TWO_SIDED|95.0|-49.68|42.66||Sample size is too small for statistical power.|ANOVA||Difference = (VR goggles group - iPad Pro group)|Articulation Accuracy does not statistically differ for the iPad Pro or VR goggle participant group after having used the VAST system for 2 months.||42.66|-49.68|0.4296
72615667|NCT04764539|144761825|SUPERIORITY||Mean Difference (Final Values)|19.75|STANDARD_DEVIATION|24.19|<|0.294|TWO_SIDED|95.0|-25.7|65.2||Sample size is too small for statistical power.|ANOVA||Difference = (iPad Pro group Post-Treatment - iPad Pro group Pre-Treatment)|Comparison of pre-test and post-test outcome per group.||65.2|-25.7|<0.294
72615668|NCT04764539|144761825|SUPERIORITY||Mean Difference (Final Values)|16.25|STANDARD_DEVIATION|19.9|<|0.419|TWO_SIDED|95.0|-33.86|66.36||Sample size is too small for statistical power.|ANOVA||Difference = (VR goggles group Post-Treatment - VR goggles group Pre-Treatment)|Comparison of pre-test and post-test outcome per group.||66.36|-33.86|<0.419
72615669|NCT04764539|144761826|SUPERIORITY||Mean Difference (Final Values)|1.33|STANDARD_DEVIATION|1.63|<|0.659|TWO_SIDED|95.0|-6.436|9.096||Sample size to small for statistical power.|ANOVA||difference = (iPad group mean - VR goggles group mean)|||9.096|-6.436|<0.659
72615670|NCT04764539|144761827|SUPERIORITY||Mean Difference (Final Values)|7.9|STANDARD_DEVIATION|9.67|<|0.789|TWO_SIDED|95.0|-68.91|84.7|||ANOVA|Sample size too small for statistical power.|Difference = (iPad Pro group - VR Goggles group)|||84.7|-68.91|<0.789
72615671|NCT04764539|144761827|SUPERIORITY||Mean Difference (Final Values)|30.16|STANDARD_DEVIATION|36.94|<|0.304|TWO_SIDED|95.0|-40.85|101.17||Sample size is too small for statistical power.|ANOVA||Difference = (iPad Pro group Post-Treatment - iPad Pro group Pre-Treatment)|Comparison of pre-test and post-test outcome per group.||101.17|-40.85|<0.304
72615672|NCT04764539|144761827|SUPERIORITY||Mean Difference (Final Values)|22.26|STANDARD_DEVIATION|27.26|<|0.403|TWO_SIDED|95.0|-43.91|88.43||Sample size is too small for statistical power.|ANOVA||Difference = (VR goggles group Post-Treatment - VR goggles group Pre-Treatment)|Comparison of pre-test and post-test outcome per group.||88.43|-43.91|<0.403
72615673|NCT04764539|144761828|SUPERIORITY||Mean Difference (Final Values)|-2.34|STANDARD_DEVIATION|2.87|<|0.485|TWO_SIDED|95.0|-10.79|6.11||Sample size is too small for statistical power.|ANOVA||Difference = (VR goggles group - iPad Pro group)|The response to treatment stimuli will not increase from baseline for the either the iPad Pro or VR goggle participant group after having used the VAST system for 2 months.||6.11|-10.79|<0.485
72615674|NCT04764539|144761828|SUPERIORITY||Mean Difference (Final Values)|5.66|STANDARD_DEVIATION|6.94|<|0.065|TWO_SIDED|95.0|-0.569|11.9||Sample size is too small for statistical power.|ANOVA||Difference = (iPad Pro group Post-Treatment - iPad Pro group Pre-Treatment)|Comparison of pre-test and post-test outcome per group.||11.9|-0.569|<0.065
72615675|NCT04764539|144761828|SUPERIORITY||Mean Difference (Final Values)|3.34|STANDARD_DEVIATION|4.09|<|0.549|TWO_SIDED|95.0|-10.85|17.53||Sample size is too small for statistical power.|ANOVA||Difference = (VR goggles group Post-Treatment - VR goggles group Pre-Treatment)|Comparison of pre-test and post-test outcome per group.||17.53|-10.85|<0.549
72615676|NCT02827708|144761843|SUPERIORITY|This hypothesis was controlled for multiplicity. Results are based on the data from the in-trial observation period. The estimated treatment effect includes the effect of any rescue medication and any effect after premature trial product discontinuation (treatment policy estimand).|Treatment difference|-0.8|||<|0.0001|TWO_SIDED|95.0|-1.0|-0.6||Unadjusted two-sided p-value for test of no difference from 0.|Pattern Mixture model||Oral semaglutide 14 mg - Placebo|The analysis was based on a pattern mixture model using multiple imputation to handle missing week 26 data, assuming that data were missing at random within the groups used for imputation. The imputed data sets were analysed using an analysis of covariance (ANCOVA) model with treatment, strata, and region as categorical fixed effects and baseline HbA1c value as covariate for each of the 1000 imputed complete data sets, and pooled by Rubin's rule to draw inference.||-0.6|-1.0|<0.0001
72615677|NCT02827708|144761843|SUPERIORITY|This hypothesis was not controlled for multiplicity. Results are based on the data from the on-treatment without rescue medication observation period. The estimated treatment effect excludes the effect of any rescue medication and any effect after premature trial product discontinuation (hypothetical estimand).|Treatment difference|-1.0|||<|0.0001||95.0|-1.2|-0.8||Unadjusted two-sided p-value for test of no difference from 0.|MMRM||Oral semaglutide 14 mg - Placebo|The analysis was based on a mixed model for repeated measurements (MMRM) that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 26. The independent effects were treatment, strata, interaction strata and region as categorical fixed effects and the baseline value as covariate, all nested within visit, and an unstructured residual covariance matrix.||-0.8|-1.2|<0.0001
72622172|NCT02592655|144774354|SUPERIORITY_OR_OTHER|||||||0.002||||||Significance thresh hold: 0.05.|McNemar|||"Null hypothesis is that one windlass tourniquet is just as likely to occlude arterial flow as the 10 cm wide tourniquet tape.~Participant count of 18 to accommodate for missing windlass tourniquet ultrasound data."||||0.002
72622173|NCT02592655|144774354|SUPERIORITY_OR_OTHER|||||||0.008||||||Significance thresh hold: 0.05.|McNemar|||"Null hypothesis is that one windlass tourniquet is just as likely to occlude arterial flow as two windlass tourniquets.~Participant count of 18 to accommodate for missing windlass tourniquet ultrasound data."||||0.008
72504418|NCT01855789|144539436|SUPERIORITY||DAS28 Remission Rate Difference|-6.8||||0.3611|TWO_SIDED|95.0|-18.2|4.6|||Cochran-Mantel-Haenszel||TCZ + PBO minus TCZ + MTX|Week 52: Analysis of association between treatment group and response, stratified by the randomization stratification factors: DAS28 remission status at Week 24 (\<2.6, \>=2.6 to \<=3.2), baseline weight-by-dosing group (\<80 kg q2w, \<80 kg qw, 80-\<100 kg q2w, 80-\<100 kg qw, \>=100 kg qw), participant anti-TNF exposure (Yes/No).||4.6|-18.2|0.3611
72615678|NCT02827708|144761844|SUPERIORITY|This hypothesis was controlled for multiplicity. Results are based on the data from the in-trial observation period. The estimated treatment effect includes the effect of any rescue medication and any effect after premature trial product discontinuation (treatment policy estimand).|Treatment difference|-2.5|||<|0.0001|TWO_SIDED|95.0|-3.2|-1.8||Unadjusted two-sided p-value for test of no difference from 0.|Pattern Mixture model||Oral semaglutide 14 mg - Placebo|The analysis was based on a pattern mixture model using multiple imputation to handle missing week 26 data, assuming that data were missing at random within the groups used for imputation. The imputed data sets were analysed using an ANCOVA model with treatment, strata, and region as categorical fixed effects and baseline body weight value as covariate for each of the 1000 imputed complete data sets, and pooled by Rubin's rule to draw inference.||-1.8|-3.2|<0.0001
72615679|NCT02827708|144761844|SUPERIORITY|This hypothesis was not controlled for multiplicity. Results are based on the data from the on-treatment without rescue medication observation period. The estimated treatment effect excludes the effect of any rescue medication and any effect after premature trial product discontinuation (hypothetical estimand).|Treatment difference|-2.7|||<|0.0001|TWO_SIDED|95.0|-3.5|-1.9||Unadjusted two-sided p-value for test of no difference from 0.|MMRM||Oral semaglutide 14 mg - Placebo|The analysis was based on a MMRM that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 26. The independent effects were treatment, strata, interaction strata and region as categorical fixed effects and the baseline value as covariate, all nested within visit, and an unstructured residual covariance matrix.||-1.9|-3.5|<0.0001
72615680|NCT02827708|144761860|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|0.64|||=|0.1834|TWO_SIDED|95.0|0.34|1.23||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox|||Time to initiation of additional anti-diabetic medication was analysed using a Cox proportional hazards model with treatment, strata, interaction strata, and region as categorical fixed effects and baseline HbA1c as covariate. Withdrawal for any reason or lost to follow-up contributed to the analysis as events (initiation of additional anti-diabetic medication). Censoring time was one day before planned end of treatment.||1.23|0.34|=0.1834
72615681|NCT02827708|144761861|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|0.43|||=|0.061|TWO_SIDED|95.0|0.17|1.04||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox|||Time to initiation of rescue medication was analysed using a Cox proportional hazards model with treatment, strata, interaction strata, and region as categorical fixed effects and baseline HbA1c as covariate. Censoring time was one day before last day on trial product.||1.04|0.17|=0.0610
72615682|NCT01137812|144761883|NON_INFERIORITY_OR_EQUIVALENCE|Power calculation: assuming a difference between canagliflozin and sitagliptin of 0.0% and a common standard deviation of 1.0%, and using a 2-sample, 1-sided t-test with a Type I error rate of 0.025, it was estimated that 234 patients per group would provide approximately 90% power to demonstrate non-inferiority with the non-inferiority margin of 0.3, comparing canagliflozin with sitagliptin.|Least-Squares Mean Difference|-0.37|STANDARD_ERROR_OF_MEAN|0.064|<|0.05|TWO_SIDED|95.0|-0.5|-0.25|||ANCOVA|||If the hypothesis of non-inferiority of canagliflozin to sitagliptin at Week 52 was demonstrated (ie, upper bound of the 95% Confidence Interval of the treatment difference \[canagliflozin minus sitagliptin\] was less than 0.3) and the upper bound was less than 0.0, the superiority of the canagliflozin dose relative to sitagliptin would be concluded.||-0.250|-0.500|<0.05
72615683|NCT01137812|144761884|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.8|||||TWO_SIDED|95.0|1.3|2.48|||Regression, Logistic|||||2.48|1.30|
72615684|NCT01137812|144761885|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-24.1|||<|0.001|TWO_SIDED|95.0|-29.89|-18.24|||ANCOVA|||||-18.24|-29.89|<0.001
72615685|NCT01137812|144761886|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-2.8|STANDARD_ERROR_OF_MEAN|0.3|<|0.001|TWO_SIDED|95.0|-3.3|-2.2|||ANCOVA|||||-2.2|-3.3|<0.001
72615686|NCT01137812|144761887|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-5.91|STANDARD_ERROR_OF_MEAN|0.883|<|0.001|TWO_SIDED|95.0|-7.642|-4.175|||ANCOVA|||||-4.175|-7.642|<0.001
72615687|NCT01137812|144761888|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-2.3|STANDARD_ERROR_OF_MEAN|3.9||0.554|TWO_SIDED|95.0|-9.8|5.3|||ANCOVA|||||5.3|-9.8|0.554
72615688|NCT01137812|144761889|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|7.0|STANDARD_ERROR_OF_MEAN|1.2|<|0.001|TWO_SIDED|95.0|4.6|9.3|||ANCOVA|||||9.3|4.6|<0.001
72615689|NCT04621760|144761892|SUPERIORITY|||||||0.51||||||a priori threshold for statistical significance: 0.05|Fisher Exact|||||||0.51
72615690|NCT04621760|144761893|SUPERIORITY|||||||0.62||||||threshold for significance: 0.05|Fisher Exact|one sided Fisher's exct test, given small cell sizes.||||||0.62
72615691|NCT04621760|144761894|SUPERIORITY|||||||0.207||||||a priori threshold for significance: 0.05|Fisher Exact|Fisher's exact test used due to small sample size||||||0.207
72615692|NCT04621760|144761895|SUPERIORITY|||||||0.496||||||a priori threshold for significance: 0.05|Fisher Exact|Fisher's exact test used due to small cell size||||||0.496
72615693|NCT04621760|144761896|SUPERIORITY|||||||0.02||||||a priori threshold for significance: 0.05|Chi-squared|||"Test comparing proportion correctly identifying PrEP is a daily pill to prevent HIV"||||0.02
72615694|NCT04621760|144761896|SUPERIORITY|||||||0.01||||||a priori threshold for significance: 0.05|Chi-squared|||"Test comparing proportion correctly responding to prompt: PrEP is for all adults"||||0.01
72615695|NCT04621760|144761896|SUPERIORITY||||||<|0.01||||||a priori threshold for significance: 0.05|Chi-squared|||"Test comparing proportion who correctly identified: PrEP will not work if taken once a week"||||<0.01
72615696|NCT04621760|144761896|SUPERIORITY||||||<|0.01||||||a priori threshold for significance: 0.05|Chi-squared|||"Test of proportion who correctly identified PrEP does not prevent STDs other than HIV"||||<0.01
72615697|NCT04621760|144761896|SUPERIORITY||||||<|0.01||||||a priori threshold for significance: 0.05|Chi-squared|||"Test comparing proportion who correctly identified, PrEP side effects do not last forever"||||<0.01
72615698|NCT04621760|144761896|SUPERIORITY|||||||0.03||||||a priori threshold for significance: 0.05|Chi-squared|||"Test comparing proportion who correctly identified, A baby could be norm to HIV discordant parents without transmitting HIV"||||0.03
72615699|NCT04621760|144761896|SUPERIORITY||||||<|0.01||||||a priori threshold for significance: 0.05|Chi-squared|||"Test comparing proportion who correctly identified There is medication you can take after sex to prevent HIV"||||<0.01
72615700|NCT04621760|144761896|SUPERIORITY|||||||0.29||||||a priori threshold for significance: 0.05|Chi-squared|||"Test for proportion who correctly identified PrEP efficacy is \> 95%"||||0.29
72615701|NCT04621760|144761897|SUPERIORITY|||||||0.04||||||a priori threshold for significance: 0.05|Chi-squared|||Given strong positive skew of responses, transformed into a binary variable comparing those with lowest possible score versus higher score. Data then tested through tests of proportions.||||0.04
72615702|NCT04621760|144761898|SUPERIORITY|||||||0.02||||||a priori threshold for significance: 0.05|Chi-squared|||Given strong positive skew of responses, transformed into a binary variable comparing those with lowest possible score versus higher score. Data then tested through tests of proportions.||||0.02
72615703|NCT04621760|144761899|SUPERIORITY|||||||0.05||||||a priori threshold for significance: 0.05|Chi-squared|||Given strong positive skew of responses, transformed into a binary variable comparing those with lowest possible score versus higher score. Data then tested through tests of proportions.||||0.05
72615704|NCT04621760|144761900|SUPERIORITY|||||||0.03||||||a priori threshold for significance: 0.05|Chi-squared|||Given strong positive skew of responses, transformed into a binary variable comparing those with lowest possible score versus higher score. Data then tested through tests of proportions.||||0.03
72615705|NCT04621760|144761901|SUPERIORITY|||||||0.07||||||a priori threshold for significance: 0.05|Chi-squared|||Given strong positive skew of responses, transformed into a binary variable comparing those with lowest possible score versus higher score. Data then tested through tests of proportions.||||0.07
72615706|NCT04621760|144761902|SUPERIORITY|||||||0.1||||||a priori threshold for significance: 0.05|Chi-squared|||Given strong positive skew of responses, transformed into a binary variable comparing those with lowest possible score versus higher score. Data then tested through tests of proportions.||||0.10
72615707|NCT04621760|144761903|SUPERIORITY|||||||0.22||||||a priori threshold for significance: 0.05|Chi-squared|||Given strong negative skew of responses, transformed into a binary variable comparing those with highest possible score versus higher score. Data then tested through tests of proportions.||||0.22
72615708|NCT04621760|144761904|SUPERIORITY|||||||0.51||||||a priori threshold for significance: 0.05|Fisher Exact|Fisher's exact test used due to small cell size||||||0.51
72615709|NCT04621760|144761905|SUPERIORITY|||||||0.9||||||a priori threshold for significance: 0.05|Fisher Exact|||Comparing confidence between treatment groups of those who said they intended to use PrEP||||0.90
72615710|NCT04621760|144761905|SUPERIORITY|||||||0.75||||||a priori threshold for significance: 0.05|Fisher Exact|||Comparing confidence between treatment groups of those who said they intended to use abstinence||||0.75
72615711|NCT04621760|144761905|SUPERIORITY|||||||0.32||||||a priori threshold for significance: 0.05|Fisher Exact|||Comparing confidence between treatment groups of those who said they intended to use PEP||||0.32
72504979|NCT01462292|144541161|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.18||||0.873|TWO_SIDED|95.0|-2.49|2.12||No adjustment for multiplicity was made, so p-values should not be used to make conclusions with regards to statistical significance|ANCOVA|Model included terms for treatment, center grouping and baseline||Treatment difference: Placebo Vs GSK2402968 6 mg||2.12|-2.49|0.873
72615712|NCT04621760|144761905|SUPERIORITY|||||||0.4||||||a priori threshold for significance: 0.05|Fisher Exact|||Comparing confidence between treatment groups of those who said they intended to use HIV testing||||0.40
72615713|NCT04621760|144761905|SUPERIORITY|||||||0.34||||||a priori threshold for significance: 0.05|Fisher Exact|||Comparing confidence between treatment groups of those who said they intended to use STD testing||||0.34
72615714|NCT04621760|144761905|SUPERIORITY|||||||0.1||||||a priori threshold for significance: 0.05|Fisher Exact|||Comparing confidence between treatment groups of those who said they intended to use Treatment as Prevention||||0.10
72615715|NCT04621760|144761906|SUPERIORITY|||||||0.01||||||a priori threshold for significance: 0.05|Chi-squared|||||||0.01
72615716|NCT04621760|144761907|SUPERIORITY|||||||0.26||||||a priori threshold for significance: 0.05|Fisher Exact|||"Comparing proportions in response to prompt The information was easy to understand"||||0.26
72615717|NCT04621760|144761907|SUPERIORITY|||||||0.26||||||a priori threshold for significance: 0.05|Fisher Exact|||"Comparing proportions in response to prompt: I got all of the information I needed"||||0.26
72615718|NCT04621760|144761907|SUPERIORITY|||||||0.59||||||a priori threshold for significance: 0.05|Fisher Exact|||||||0.59
72615719|NCT04621760|144761907|SUPERIORITY|||||||0.17||||||a priori threshold for significance: 0.05|Fisher Exact|||"Comparing proportions in response to prompt: The information felt useful to me"||||0.17
72615720|NCT04621760|144761908|SUPERIORITY|||||||0.74|||||||Chi-squared|||"Testing proportion of acceptability of abstinence method (proportion that responded great for me)"||||0.74
72615721|NCT04621760|144761908|SUPERIORITY|||||||0.59|||||||Chi-squared|||"Testing proportion of acceptability of condoms method (proportion that responded great for me)"||||0.59
72615722|NCT04621760|144761908|SUPERIORITY|||||||0.66|||||||Chi-squared|||"Testing proportion of acceptability of PEP method (proportion that responded great for me)"||||0.66
72615723|NCT04621760|144761908|SUPERIORITY|||||||0.49|||||||Chi-squared|||"Testing proportion of acceptability of PrEP method (proportion that responded great for me)"||||0.49
72615724|NCT04621760|144761908|SUPERIORITY|||||||0.94|||||||Chi-squared|||"Testing proportion of acceptability of HIV testing method (proportion that responded great for me)"||||0.94
72615725|NCT04621760|144761908|SUPERIORITY|||||||0.95|||||||Chi-squared|||"Testing proportion of acceptability of STD testing method (proportion that responded great for me)"||||0.95
72615726|NCT04621760|144761908|SUPERIORITY|||||||0.39|||||||Chi-squared|||"Testing proportion of acceptability of Treatment as prevention method (proportion that responded great for me)"||||0.39
72615727|NCT04621760|144761914|SUPERIORITY|||||||0.13||||||a priori threshold for significance: 0.05|Fisher Exact|||||||0.13
72615728|NCT04621760|144761915|SUPERIORITY|||||||0.08||||||a priori threshold for significance: 0.05|Fisher Exact|||||||0.08
72615729|NCT02421211|144761916|SUPERIORITY_OR_OTHER||LS means ratio|4.7|||||TWO_SIDED|90.0|3.4|6.5||||||||6.5|3.4|
72615730|NCT02421211|144761917|SUPERIORITY_OR_OTHER||LS means ratio|2.3|||||TWO_SIDED|90.0|2.0|2.8||||||||2.8|2.0|
72615731|NCT02421211|144761918|SUPERIORITY_OR_OTHER||LS means ratio|3.1|||||TWO_SIDED|90.0|2.4|3.8||||||||3.8|2.4|
72615732|NCT02421211|144761919|SUPERIORITY_OR_OTHER||LS means ratio|1.7|||||TWO_SIDED|90.0|1.5|2.0||||||||2.0|1.5|
72615733|NCT02421211|144761920|SUPERIORITY_OR_OTHER||LS means ratio|1.6|||||TWO_SIDED|90.0|1.4|1.9||||||||1.9|1.4|
72615734|NCT02421211|144761921|SUPERIORITY_OR_OTHER||LS means ratio|1.7|||||TWO_SIDED|90.0|1.6|2.0||||||||2.0|1.6|
72615735|NCT04602000|144761940|SUPERIORITY||Difference estimated using CMH weights|-8.0|||<|0.0001|TWO_SIDED|95.0|-11.7|-4.5|||Cochran-Mantel-Haenszel|P-value was calculated using CMH test stratified by age (≥60 vs. \<60 years), baseline comorbidities (Yes vs. No) and region (US vs. EU vs. Other)|The 95% stratified Newcombe CI with CMH weights was presented.|||-4.5|-11.7|<0.0001
72615736|NCT00471354|144761957|SUPERIORITY_OR_OTHER|||||||0.293||95.0|||||Spearman Partial Rank Order Correlation|||||||0.293
72615737|NCT00471354|144761958|SUPERIORITY_OR_OTHER|||||||0.276||95.0||||P-value for Correlation with Language Scores|Spearman Partial Rank Order Correlation|||||||0.276
72615738|NCT00471354|144761958|SUPERIORITY_OR_OTHER|||||||0.11||95.0||||P-value for Correlation with Math Scores.|Spearman Partial Rank Order Correlation|||||||0.110
72615739|NCT00471354|144761958|SUPERIORITY_OR_OTHER|||||||0.464||95.0||||P-value for Correlation with Science Scores.|Spearman Partial Rank Order Correlation|||||||0.464
72615740|NCT00471354|144761959|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Change from Baseline in Language Scores.|Paired t-test|||||||<0.001
72615741|NCT00471354|144761959|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Change from Baseline in Math Scores.|Paired t-test|||||||<0.001
72615742|NCT00471354|144761959|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Change from Baseline in Science Scores.|Paired t-test|||||||<0.001
72615743|NCT00471354|144761959|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Change from Baseline in Total Scores.|Paired t-test|||||||<0.001
72615744|NCT00471354|144761960|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Paired t-test|||||||<0.001
72615745|NCT00471354|144761961|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Paired t-test|||||||<0.001
72615746|NCT00471354|144761963|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Paired t-test|||||||<0.001
72615747|NCT02942407|144761997|NON_INFERIORITY|Due to a lower recruitment rate than anticipated in the early stage of the trial, the sample size was curtailed from 760 to 230 patients. Thus, under the initial protocol assumptions, the study is considered under-powered for the two-sided upper 95% CI on the HR to rule-out the non-inferiority margin of 1.40.|Hazard Ratio (HR)|1.2||||0.321|TWO_SIDED|95.0|0.63|2.3|||Regression, Cox|Cox model was adjusted for prior warfarin status (naive vs experienced) and treatment (apixaban vs warfarin)|Time from randomization to first occurrence of outcome was modeled. If no event, censored at earliest of: most recent date of evaluation of outcome, month 15 target (460 days + randomization date), or end of study date (July 27, 2019).|Exploratory analysis due to failure to reach initial sample size: Non-inferiority (NI) null hypothesis: HR \>= 1.4 (Non-inferiority).||2.3|0.63|0.321
72615748|NCT02942407|144761997|SUPERIORITY|Exploratory analysis due to lack of achieving initial sample size.|Hazard Ratio (HR)|1.2||||0.583|TWO_SIDED|95.0|0.63|2.3||If upper limit of 95% confidence interval \< 1 this would be considered evidence of superiority.|Regression, Cox|Cox model was adjusted for prior warfarin status (naive vs experienced) and treatment (apixaban vs warfarin).|Time from randomization to first occurrence of outcome was modeled. If no event, censored at earliest of: most recent date of evaluation of outcome, month 15 target (460 days + randomization date), or end of study date (July 27, 2019).|||2.3|0.63|0.583
72615749|NCT02942407|144761999|SUPERIORITY||Hazard Ratio (HR)|1.47|||||TWO_SIDED|95.0|0.74|2.93||No p-value provided as analysis is considered exploratory due to study being under powered.||||Hazard ratios (apixaban vs warfarin) and 95% confidence intervals obtained using Cox model adjusted for prior warfarin status (naive vs experienced) and treatment. Time from randomization to first occurrence of the composite outcome/censoring date modeled. Those that did not experience the outcome are censored at the earliest of the following: 1) most recent date of evaluation of all of the components, 2) month 15 target (460 days + randomization date), and end of study date (July 27, 2019).||2.93|0.74|
72615750|NCT02942407|144762008|SUPERIORITY||Hazard Ratio (HR)|1.2|||||TWO_SIDED|95.0|0.67|2.17||No p-value provided as analysis is considered exploratory due to study being under powered.||||Hazard ratios (apixaban vs warfarin) and 95% confidence intervals obtained using Cox model adjusted for prior warfarin status (naive vs experienced) and treatment. Time from randomization to first occurrence of the composite outcome/censoring date modeled. Those that did not experience the outcome are censored at the earliest of the following: 1) most recent date of evaluation of all of the components, 2) month 15 target (460 days + randomization date), and end of stud date (July 27, 2019).||2.17|0.67|
72615751|NCT06377488|144762010|SUPERIORITY||least-square mean estimate|-0.085|STANDARD_ERROR_OF_MEAN|0.0139|||TWO_SIDED|95.0|-0.115|-0.056|||Mixed Model Analysis|The Satterthwaite Method was used for the calculation of the denominator degrees of freedom.|Visual Acuity scores at distance was estimated using 95% confidence intervals (CI) constructed for the least-square mean (LSM).|It was calculated using a 1-sided one-sample mean t-test with a family wise type I error rate of 5% with at least 99% statistical power, that 9, 6 and 29 subjects were required to test the primary hypotheses for distance, intermediate and near, respectively.||-0.056|-0.115|
72615752|NCT06377488|144762010|SUPERIORITY||least-square mean estimate|-0.023|STANDARD_ERROR_OF_MEAN|0.0131|||TWO_SIDED|95.0|-0.05|0.005|||Mixed Model Analysis|The Satterthwaite Method was used for the calculation of the denominator degrees of freedom.|Visual Acuity scores at intermediate was estimated using 95% confidence intervals (CI) constructed for the least-square mean (LSM).|It was calculated using a 1-sided one-sample mean t-test with a family wise type I error rate of 5% with at least 99% statistical power, that 9, 6 and 29 subjects were required to test the primary hypotheses for distance, intermediate and near, respectively.||0.005|-0.050|
72615753|NCT06377488|144762010|SUPERIORITY||least-square mean estimate|0.083|STANDARD_ERROR_OF_MEAN|0.0152|||TWO_SIDED|95.0|0.051|0.116|||Mixed Model Analysis|The Satterthwaite Method was used for the calculation of the denominator degrees of freedom.|Visual Acuity scores at near was estimated using 95% confidence intervals (CI) constructed for the least-square mean (LSM).|It was calculated using a 1-sided one-sample mean t-test with a family wise type I error rate of 5% with at least 99% statistical power, that 9, 6 and 29 subjects were required to test the primary hypotheses for distance, intermediate and near, respectively.||0.116|0.051|
72615754|NCT06377488|144762011|SUPERIORITY||Mean Population Estimate|62.1|STANDARD_ERROR_OF_MEAN|2.6|||TWO_SIDED|95.0|56.7|67.5|||Mixed Model Analysis|The Satterthwaite Method was used for the calculation of the denominator degrees of freedom.|Mean estimates were conducted for myopes only using two-sided confidence intervals (CI) constructed for the least square mean.|It was calculated using a 1-sided one-sample mean t-test with a family wise type I error rate of 5% with at least 99% statistical power, that 23 and 29 subjects were required to test for superiority for CLUE vision scores for hyperopes and myopes, respectively.||67.5|56.7|
72615755|NCT06377488|144762011|SUPERIORITY||Mean Population Estimate|57.8|STANDARD_ERROR_OF_MEAN|3.02|||TWO_SIDED|95.0|51.7|64.0|||Mixed Model Analysis|The Satterthwaite Method was used for the calculation of the denominator degrees of freedom.|Mean estimates were conducted for hyperopes only using two-sided confidence intervals (CI) constructed for the least square mean.|It was calculated using a 1-sided one-sample mean t-test with a family wise type I error rate of 5% with at least 99% statistical power, that 23 and 29 subjects were required to test for superiority for CLUE vision scores for hyperopes and myopes, respectively.||64.0|51.7|
72615756|NCT06377488|144762012|SUPERIORITY||Central Posterior Mean Estimate|0.943|STANDARD_DEVIATION|0.0155|||TWO_SIDED|95.0|0.908|0.968|||Bayesian beta-binomial model|Bayesian beta-binomial model with correlated binary data||It was calculated using a Bayesian beta-binomial model for correlated data with a reference rate of 0.902 and an intraclass correlation of 0.70, that 140 subjects were required to test for superiority to achieve a minimum statistical power of 96% with 95% central posterior credible interval.||0.968|0.908|
72615757|NCT06377488|144762013|SUPERIORITY||Central Posterior Mean Estimate|0.988|STANDARD_DEVIATION|0.0058|||TWO_SIDED|95.0|0.974|0.997|||Bayesian beta-binomial model|Bayesian beta-binomial model with correlated binary data||It was calculated using a Bayesian beta-binomial model for correlated data with a reference rate of 0.99 and an intraclass correlation of 0.70, that 140 subjects were required to test for superiority to achieve a minimum statistical power of 96% with 95% central posterior credible interval.||0.997|0.974|
72615758|NCT06377488|144762014|SUPERIORITY||Central Posterior Mean Estimate|0.006|STANDARD_DEVIATION|0.0047|||TWO_SIDED|95.0|0.0|0.017|||Bayesian beta-binomial model|Bayesian beta-binomial model with correlated binary data||It was calculated that 140 subjects were required to test for superiority to achieve a minimum statistical power of 99% with 95% central posterior credible.||0.017|0.000|
72615759|NCT06377488|144762015|SUPERIORITY||Central Posterior Mean Estimate|0.003|STANDARD_DEVIATION|0.0029|||TWO_SIDED|95.0|0.0|0.011|||Bayesian beta-binomial model|Bayesian beta-binomial model with correlated binary data||It was calculated that 140 subjects were required to test for superiority to achieve a minimum statistical power of 99% with 95% central posterior credible.||0.011|0.000|
72615760|NCT06377488|144762016|SUPERIORITY||Least-square mean estimate|57.8|STANDARD_ERROR_OF_MEAN|3.02|||TWO_SIDED|95.0|51.7|64.0|||Mixed Model Analysis|The Satterthwaite Method was used for the calculation of the denominator degrees of freedom.|This is the analysis for hyperopes only. Mean estimates were conducted using two-sided confidence intervals (CI) constructed for the least square mean.|It was calculated using a one-sided one-sample mean t-test with a family wise type I error rate of 5% with at least 99% statistical power, that 42 and 55 subjects were required to test for superiority for CLUE vision scores for hyperopes and myopes, respectively.||64.0|51.7|
72615761|NCT06377488|144762016|SUPERIORITY||Least-square mean estimate|62.1|STANDARD_ERROR_OF_MEAN|2.6|||TWO_SIDED|95.0|56.7|67.5|||Mixed Model Analysis|The Satterthwaite Method was used for the calculation of the denominator degrees of freedom.|This is the analysis for myopes only. Mean estimates were conducted using two-sided confidence intervals (CI) constructed for the least square mean.|It was calculated using a one-sided one-sample mean t-test with a family wise type I error rate of 5% with at least 99% statistical power, that 42 and 55 subjects were required to test for superiority for CLUE vision scores for hyperopes and myopes, respectively.||67.5|56.7|
72615762|NCT06377488|144762017|SUPERIORITY||Mean Population Estimate|64.7|STANDARD_ERROR_OF_MEAN|3.02|||TWO_SIDED|95.0|58.6|70.8|||Mixed Model Analysis|The Satterthwaite Method was used for the calculation of the denominator degrees of freedom.|Mean estimates were conducted for hyperopes using two-sided confidence intervals (CI) constructed for the least square mean.|It was calculated using a one-sided one-sample mean t-test with a family wise type I error rate of 5% with at least 99% statistical power, that 23 and 46 subjects were required to test for superiority for CLUE comfort scores for hyperopes and myopes, respectively.||70.8|58.6|
72615763|NCT06377488|144762017|SUPERIORITY||Mean Population Estimate|64.2|STANDARD_ERROR_OF_MEAN|2.54|||TWO_SIDED|95.0|59.0|69.5|||Mixed Model Analysis|The Satterthwaite Method was used for the calculation of the denominator degrees of freedom.|Mean estimates were conducted for myopes using two-sided confidence intervals (CI) constructed for the least square mean.|It was calculated using a one-sided one-sample mean t-test with a family wise type I error rate of 5% with at least 99% statistical power, that 23 and 46 subjects were required to test for superiority for CLUE comfort scores for hyperopes and myopes, respectively.||69.5|59.0|
72615764|NCT06377488|144762018|SUPERIORITY||Mean Population Estimate|67.9|STANDARD_ERROR_OF_MEAN|2.79|||TWO_SIDED|95.0|62.2|73.5|||Mixed Model Analysis|The Satterthwaite Method was used for the calculation of the denominator degrees of freedom.|Mean estimates were conducted for hyperopes using two-sided confidence intervals (CI) constructed for the least square mean.|It was calculated using a one-sided one-sample mean t-test with a family wise type I error rate of 5% with at least 99% statistical power, that 15 and 26 subjects were required to test for superiority for CLUE handling scores for hyperopes and myopes, respectively.||73.5|62.2|
72615765|NCT06377488|144762018|SUPERIORITY||Mean Population Estimate|67.0|STANDARD_ERROR_OF_MEAN|2.32|||TWO_SIDED|95.0|62.2|71.8|||Mixed Model Analysis|The Satterthwaite Method was used for the calculation of the denominator degrees of freedom.|Mean estimates were conducted for myopes using two-sided confidence intervals (CI) constructed for the least square mean.|It was calculated using a one-sided one-sample mean t-test with a family wise type I error rate of 5% with at least 99% statistical power, that 15 and 26 subjects were required to test for superiority for CLUE handling scores for hyperopes and myopes, respectively.||71.8|62.2|
72615766|NCT06377488|144762019|SUPERIORITY||Central Posterior Mean Estimate|0.966|STANDARD_DEVIATION|0.0135|||TWO_SIDED|95.0|0.933|0.988|||Bayesian beta-binomial model|Bayesian beta-binomial model with correlated binary data.||It was calculated using a Bayesian beta-binomial model for correlated data with a reference rate of 0.99 and an intraclass correlation of 0.70 with 5000 replicating trials, that 140 subjects were required to test for superiority to achieve a minimum statistical power of 99% with 95% central posterior credible.||0.988|0.933|
72615767|NCT00387127|144762033|SUPERIORITY_OR_OTHER||Difference in percentage of par. with CR|10.7||||0.3658|TWO_SIDED|95.0|-13.4|37.3||From exact test that common odds ratio equals 1|Fisher Exact||Complete response was defined as the percentage of participants achieving a CR as determined by an independent radiological review.|||37.3|-13.4|0.3658
72615768|NCT00387127|144762034|SUPERIORITY_OR_OTHER||Difference in percentage of par. with CR|28.8||||0.013|TWO_SIDED|95.0|5.7|53.6||From exact test that common odds ratio equals 1|Fisher Exact||Complete response was defined as the percentage of participants achieving a CR as determined by the investigator.|||53.6|5.7|0.0130
72615769|NCT00387127|144762043|SUPERIORITY_OR_OTHER||Difference in overall response rate|16.3||||0.1969|TWO_SIDED|95.0|-8.6|42.1||From exact test that common odds ratio equals 1|Fisher Exact||Overall response was defined as the percentage of participants achieving a PR or CR as determined by the investigator.|||42.1|-8.6|0.1969
72615770|NCT00699751|144762073|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.691||||5e-05|TWO_SIDED|95.0|0.578|0.827|||Log Rank|Stratified by total ALP, current use of bisphosphonates and prior use of Docetaxel.|The hazard ratio (Alpharadin:Placebo) is from a Cox proportional hazards model stratified by total ALP, current use of bisphosphonates and prior use of Docetaxel.|The null hypothesis for the comparison of overall survival, and also for the secondary endpoints, is that there is no difference between Alpharadin and placebo for that endpoint; the alternative hypothesis is that a difference exists.||0.827|0.578|0.00005
72615771|NCT00699751|144762074|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.169|||<|1e-05|TWO_SIDED|95.0|0.131|0.22|||Log Rank|Stratified by total ALP, current use of bisphosphonates and prior use of Docetaxel.|The hazard ratio (Alpharadin:Placebo) is from a Cox proportional hazards model stratified by total ALP, current use of bisphosphonates and prior use of Docetaxel.|The null hypothesis for the comparison of time to total ALP progression, is that there is no difference between Alpharadin and placebo for that endpoint; the alternative hypothesis is that a difference exists.||0.22|0.131|<0.00001
72615772|NCT00699751|144762075|SUPERIORITY_OR_OTHER||||||<|0.001||||||\>=30% reduction in blood level|Cochran-Mantel-Haenszel|adjusting for the binary stratification factors, total ALP, current use of Bisphosphonates and prior use of Docetaxel.||The null hypothesis for the comparison of \>=30% reduction in blood level, is that there is no difference between Alpharadin and placebo for that endpoint; the alternative hypothesis is that a difference exists.||||<0.001
72615773|NCT00699751|144762075|SUPERIORITY_OR_OTHER||||||<|0.001||||||\>=50% reduction in blood level|Cochran-Mantel-Haenszel|adjusting for the binary stratification factors, total ALP, current use of Bisphosphonates and prior use of Docetaxel.||The null hypothesis for the comparison of \>=50% reduction in blood level, is that there is no difference between Alpharadin and placebo for that endpoint; the alternative hypothesis is that a difference exists.||||<0.001
72615774|NCT00699751|144762075|SUPERIORITY_OR_OTHER||||||<|0.001||||||Confirmed Total ALP Response (\>=30%)|Cochran-Mantel-Haenszel|adjusting for the binary stratification factors, total ALP, current use of Bisphosphonates and prior use of Docetaxel.||The null hypothesis for the comparison of Confirmed Total ALP Response (\>=30%), is that there is no difference between Alpharadin and placebo for that endpoint; the alternative hypothesis is that a difference exists.||||<0.001
72615775|NCT00699751|144762075|SUPERIORITY_OR_OTHER||||||<|0.001||||||Confirmed Total ALP Response (\>=50%)|Cochran-Mantel-Haenszel|adjusting for the binary stratification factors, total ALP, current use of Bisphosphonates and prior use of Docetaxel.||The null hypothesis for the comparison of Confirmed Total ALP Response (\>=50%), is that there is no difference between Alpharadin and placebo for that endpoint; the alternative hypothesis is that a difference exists.||||<0.001
72615776|NCT00699751|144762076|SUPERIORITY_OR_OTHER||||||<|0.001||||||\>=30% reduction in blood level|Cochran-Mantel-Haenszel|adjusting for the binary stratification factors, total ALP, current use of Bisphosphonates and prior use of Docetaxel.||The null hypothesis for the comparison of \>=30% reduction in blood level, is that there is no difference between Alpharadin and placebo for that endpoint; the alternative hypothesis is that a difference exists.||||<0.001
72615777|NCT00699751|144762076|SUPERIORITY_OR_OTHER||||||<|0.001||||||\>=50% reduction in blood level|Cochran-Mantel-Haenszel|adjusting for the binary stratification factors, total ALP, current use of Bisphosphonates and prior use of Docetaxel.||The null hypothesis for the comparison of \>=50% reduction in blood level, is that there is no difference between Alpharadin and placebo for that endpoint; the alternative hypothesis is that a difference exists.||||<0.001
72615778|NCT00699751|144762076|SUPERIORITY_OR_OTHER||||||<|0.001||||||Confirmed Total ALP Response (\>=50%)|Cochran-Mantel-Haenszel|adjusting for the binary stratification factors, total ALP, current use of Bisphosphonates and prior use of Docetaxel.||The null hypothesis for the comparison of Confirmed Total ALP Response (\>=50%), is that there is no difference between Alpharadin and placebo for that endpoint; the alternative hypothesis is that a difference exists.||||<0.001
72615779|NCT00699751|144762077|SUPERIORITY_OR_OTHER||||||<|0.001||||||Total ALP normalization|Cochran-Mantel-Haenszel|adjusting for the binary stratification factors, total ALP, current use of Bisphosphonates and prior use of Docetaxel.||The null hypothesis for the comparison of Total ALP normalization, is that there is no difference between Alpharadin and placebo for that endpoint; the alternative hypothesis is that a difference exists.||||<0.001
72432093|NCT00797225|144376623|SUPERIORITY||-0.33|-0.33|STANDARD_ERROR_OF_MEAN|0.1||0.0007|TWO_SIDED|95.0|-0.52|-0.14|||Mixed-effects Repeated Measures Model|||Analysis at Week 8. The change from baseline in monthly mean sum of dysmenorrhea and non-menstrual pelvic pain scores was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.||-0.14|-0.52|0.0007
72615780|NCT00699751|144762078|SUPERIORITY_OR_OTHER||||||<|0.001||||||Percentage Change from Baseline|ANCOVA|adjusting for the binary stratification factors, total ALP, current use of Bisphosphonates and prior use of Docetaxel.||The null hypothesis for the comparison of Percentage change from baseline, is that there is no difference between Alpharadin and placebo for that endpoint; the alternative hypothesis is that a difference exists.||||<0.001
72615781|NCT00699751|144762079|SUPERIORITY_OR_OTHER||||||<|0.001||||||Maximum Percentage decrease from baseline to week 12|ANCOVA|Adjusting for the binary stratification factors, total ALP, current use of Bisphosphonates and prior use of Docetaxel.||The null hypothesis for the comparison of Maximum Percentage decrease from baseline to week 12, is that there is no difference between Alpharadin and placebo for that endpoint; the alternative hypothesis is that a difference exists.||||<0.001
72615782|NCT00699751|144762080|SUPERIORITY_OR_OTHER||||||<|0.001||||||Percentage change from baseline|ANCOVA|adjusting for the binary stratification factors, total ALP, current use of Bisphosphonates and prior use of Docetaxel.||The null hypothesis for the comparison of Percentage change from baseline, is that there is no difference between Alpharadin and placebo for that endpoint; the alternative hypothesis is that a difference exists.||||<0.001
72615783|NCT00699751|144762081|SUPERIORITY_OR_OTHER||||||<|0.001||||||Maximum Percentage decrease from baseline during the 24 week treatment|ANCOVA|adjusting for the binary stratification factors, total ALP, current use of Bisphosphonates and prior use of Docetaxel.||The null hypothesis for the comparison of Maximum Percentage decrease from baseline during the 24 week treatment, is that there is no difference between Alpharadin and placebo for that endpoint; the alternative hypothesis is that a difference exists.||||<0.001
72615784|NCT00699751|144762082|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.643|||<|1e-05|TWO_SIDED|95.0|0.539|0.768||Time to Prostate Specific Antigen (PSA) progression|Log Rank|Stratified by total ALP, current use of bisphosphonates and prior use of Docetaxel.|The hazard ratio (Alpharadin:Placebo) is from a Cox proportional hazards model stratified by total ALP, current use of bisphosphonates and prior use of Docetaxel.|The null hypothesis for the comparison of Time to PSA progression, is that there is no difference between Alpharadin and placebo for that endpoint; the alternative hypothesis is that a difference exists.||0.768|0.539|<0.00001
72615785|NCT00699751|144762083|SUPERIORITY_OR_OTHER||||||<|0.001||||||\>=30% reduction in blood level|Cochran-Mantel-Haenszel|Adjusting for the binary stratification factors, total ALP, current use of Bisphosphonates and prior use of Docetaxel.||The null hypothesis for the comparison of \>=30% reduction in blood level, is that there is no difference between Alpharadin and placebo for that endpoint; the alternative hypothesis is that a difference exists.||||<0.001
72615786|NCT00699751|144762083|SUPERIORITY_OR_OTHER|||||||0.106||||||\>=50% reduction in blood level|Cochran-Mantel-Haenszel|adjusting for the binary stratification factors, total ALP, current use of Bisphosphonates and prior use of Docetaxel.||The null hypothesis for the comparison of \>=50% reduction in blood level, is that there is no difference between Alpharadin and placebo for that endpoint; the alternative hypothesis is that a difference exists.||||0.106
72615787|NCT00699751|144762083|SUPERIORITY_OR_OTHER|||||||0.032||||||Confirmed PSA Response(\>=50%)|Cochran-Mantel-Haenszel|Adjusting for the binary stratification factors, total ALP, current use of Bisphosphonates and prior use of Docetaxel.||The null hypothesis for the comparison of Confirmed PSA Response(\>=50%), is that there is no difference between Alpharadin and placebo for that endpoint; the alternative hypothesis is that a difference exists.||||0.032
72615788|NCT00699751|144762084|SUPERIORITY_OR_OTHER||||||<|0.001||||||\>=30% reduction in blood level|Cochran-Mantel-Haenszel|Adjusting for the binary stratification factors, total ALP, current use of Bisphosphonates and prior use of Docetaxel.||The null hypothesis for the comparison of \>=30% reduction in blood level, is that there is no difference between Alpharadin and placebo for that endpoint; the alternative hypothesis is that a difference exists.||||<0.001
72615789|NCT00699751|144762084|SUPERIORITY_OR_OTHER|||||||0.002||||||\>=50% reduction in blood level|Cochran-Mantel-Haenszel|Adjusting for the binary stratification factors, total ALP, current use of Bisphosphonates and prior use of Docetaxel.||The null hypothesis for the comparison of \>=50% reduction in blood level, is that there is no difference between Alpharadin and placebo for that endpoint; the alternative hypothesis is that a difference exists.||||0.002
72615790|NCT00699751|144762084|SUPERIORITY_OR_OTHER|||||||0.005||||||Confirmed PSA Response(\>=50%)|Cochran-Mantel-Haenszel|Adjusting for the binary stratification factors, total ALP, current use of Bisphosphonates and prior use of Docetaxel.||The null hypothesis for the comparison of Confirmed PSA Response(\>=50%), is that there is no difference between Alpharadin and placebo for that endpoint; the alternative hypothesis is that a difference exists.||||0.005
72615791|NCT00699751|144762085|SUPERIORITY_OR_OTHER|||||||0.16||||||Percentage change from baseline in PSA at Week 12|ANCOVA|Adjusting for the binary stratification factors, total ALP, current use of Bisphosphonates and prior use of Docetaxel.||The null hypothesis for the comparison of Percentage change from baseline in PSA at Week 12, is that there is no difference between Alpharadin and placebo for that endpoint; the alternative hypothesis is that a difference exists.||||0.160
72615792|NCT00699751|144762086|SUPERIORITY_OR_OTHER|||||||0.004||||||Maximum Percentage Decrease from Baseline up to Week 12|ANCOVA|Adjusting for the binary stratification factors, total ALP, current use of Bisphosphonates and prior use of Docetaxel.||The null hypothesis for the comparison of Maximum Percentage Decrease from Baseline up to Week 12, is that there is no difference between Alpharadin and placebo for that endpoint; the alternative hypothesis is that a difference exists.||||0.004
72615793|NCT00699751|144762087|SUPERIORITY_OR_OTHER|||||||0.009||||||Percentage change from baseline in PSA at EOT|ANCOVA|Adjusting for the binary stratification factors, total ALP, current use of Bisphosphonates and prior use of Docetaxel.||The null hypothesis for the comparison of Percentage change from baseline in PSA at EOT, is that there is no difference between Alpharadin and placebo for that endpoint; the alternative hypothesis is that a difference exists.||||0.009
72615794|NCT00699751|144762088|SUPERIORITY_OR_OTHER||||||<|0.001||||||Maximum Percentage Decrease from Baseline in PSA response During the 24 Week Treatment Period|ANCOVA|Adjusting for the binary stratification factors, total ALP, current use of Bisphosphonates and prior use of Docetaxel.||The null hypothesis for the comparison of Maximum Percentage Decrease from Baseline in PSA response During the 24 Week Treatment Period, is that there is no difference between Alpharadin and placebo for that endpoint; the alternative hypothesis is that a difference exists.||||<0.001
72615795|NCT00699751|144762089|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.657||||0.00012|TWO_SIDED|95.0|0.529|0.814||Time to first Skeletal Related Event (SRE)|Log Rank|Stratified by total ALP, current use of bisphosphonates and prior use of Docetaxel.|The hazard ratio (Alpharadin:Placebo) is from a Cox proportional hazards model stratified by total ALP, current use of bisphosphonates and prior use of Docetaxel.|The null hypothesis for the comparison of time to first SRE, is that there is no difference between Alpharadin and placebo for that endpoint; the alternative hypothesis is that a difference exists||0.814|0.529|0.00012
72615796|NCT00699751|144762090|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.639||||8e-05|TWO_SIDED|95.0|0.511|0.8||Time to External Beam Radiotherapy|Log Rank|Stratified by total ALP, current use of bisphosphonates and prior use of Docetaxel.|The hazard ratio (Alpharadin:Placebo) is from a Cox proportional hazards model stratified by total ALP, current use of bisphosphonates and prior use of Docetaxel.|The null hypothesis for the comparison of time to EBRT, is that there is no difference between Alpharadin and placebo for that endpoint; the alternative hypothesis is that a difference exists||0.8|0.511|0.00008
72554914|NCT04278560|144641732|SUPERIORITY||Mean Difference (Net)|1.2||||0.03|TWO_SIDED||||||ANOVA|We used change from baseline for this analysis. Two-Way Repeated Measure ANOVA: Group, Time, Group x Time, and controlled baseline.||||||0.03
72615797|NCT00699751|144762091|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.344||||0.00191|TWO_SIDED|95.0|0.17|0.695||stratified by total ALP, current use of bisphosphonates and prior use of Docetaxel.|Log Rank|Stratified by total ALP, current use of bisphosphonates and prior use of Docetaxel.|The hazard ratio (Alpharadin:Placebo) is from a Cox proportional hazards model stratified by total ALP, current use of bisphosphonates and prior use of Docetaxel.|The null hypothesis for the comparison of Time to Receiving Radio-isotope, is that there is no difference between Alpharadin and placebo for that endpoint; the alternative hypothesis is that a difference exists||0.695|0.17|0.00191
72615798|NCT00699751|144762092|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.847||||0.53277|TWO_SIDED|95.0|0.504|1.426||Time to Pathological Bone Fracture|Log Rank|Stratified by total ALP, current use of bisphosphonates and prior use of Docetaxel.|The hazard ratio (Alpharadin:Placebo) is from a Cox proportional hazards model stratified by total ALP, current use of bisphosphonates and prior use of Docetaxel.|The null hypothesis for the comparison of Time to Pathological Bone Fracture, is that there is no difference between Alpharadin and placebo for that endpoint; the alternative hypothesis is that a difference exists||1.426|0.504|0.53277
72615799|NCT00699751|144762093|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.949||||0.89567|TWO_SIDED|95.0|0.435|2.07||Time to Surgical Intervention|Log Rank|Stratified by total ALP, current use of bisphosphonates and prior use of Docetaxel.|The hazard ratio (Alpharadin:Placebo) is from a Cox proportional hazards model stratified by total ALP, current use of bisphosphonates and prior use of Docetaxel.|The null hypothesis for the comparison of Time to Surgical Intervention, is that there is no difference between Alpharadin and placebo for that endpoint; the alternative hypothesis is that a difference exists||2.07|0.435|0.89567
72615800|NCT00699751|144762094|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.68||||0.14486|TWO_SIDED|95.0|0.404|1.145||Time to Spinal Cord Compression|Log Rank|Stratified by total ALP, current use of bisphosphonates and prior use of Docetaxel.|The hazard ratio (Alpharadin:Placebo) is from a Cox proportional hazards model stratified by total ALP, current use of bisphosphonates and prior use of Docetaxel.|The null hypothesis for the comparison of Time to Spinal Cord Compression, is that there is no difference between Alpharadin and placebo for that endpoint; the alternative hypothesis is that a difference exists.||1.145|0.404|0.14486
72615801|NCT00699751|144762095|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.727||||0.00932|TWO_SIDED|95.0|0.571|0.925||Time to Other Cancer Treatment|Log Rank|Stratified by total ALP, current use of bisphosphonates and prior use of Docetaxel.|The hazard ratio (Alpharadin:Placebo) is from a Cox proportional hazards model stratified by total ALP, current use of bisphosphonates and prior use of Docetaxel.|The null hypothesis for the comparison of Time to Other Cancer Treatment, is that there is no difference between Alpharadin and placebo for that endpoint; the alternative hypothesis is that a difference exists.||0.925|0.571|0.00932
72615802|NCT00699751|144762096|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.69||||0.00187|TWO_SIDED|95.0|0.546|0.873||Time to Marked Deterioration of ECOG PS|Log Rank|Stratified by total ALP, current use of bisphosphonates and prior use of Docetaxel.|The hazard ratio (Alpharadin:Placebo) is from a Cox proportional hazards model stratified by total ALP, current use of bisphosphonates and prior use of Docetaxel.|The null hypothesis for the comparison of Time to Marked Deterioration of ECOG PS, is that there is no difference between Alpharadin and placebo for that endpoint; the alternative hypothesis is that a difference exists.||0.873|0.546|0.00187
72615803|NCT02184156|144762140|SUPERIORITY|||||||0.02|||||||t-test, 2 sided|||||||0.02
72615804|NCT02184156|144762141|SUPERIORITY|||||||0.25|||||||t-test, 2 sided|||||||0.25
72432094|NCT00797225|144376623|SUPERIORITY||LS Mean Difference|-0.43|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001|TWO_SIDED|95.0|-0.62|-0.24|||Mixed-effects Repeated Measures Model|||Analysis at Week 8. The change from baseline in monthly mean sum of dysmenorrhea and non-menstrual pelvic pain scores was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.||-0.24|-0.62|< 0.0001
72615805|NCT00002874|144762142|SUPERIORITY||Hazard Ratio (HR)|0.77||||0.02|TWO_SIDED|95.0|0.59|0.98||One-sided significance level = 0.046 to preserve overall significance level of 0.05 for the study.|Log Rank||Stratifying variables were fixed covariates: prior hormone therapy (yes/no), entry prostate-specific antigen (PSA) (1.6-4.0 vs. 0.2-1.5), PSA nadir after surgery (\< 0.5 vs. \>= 0.5), positive surgical margins (yes/no). Reference level = placebo arm.|||0.98|0.59|0.020
72615806|NCT00002874|144762143|SUPERIORITY||Cox Proportional Hazard|1.1||||0.289|TWO_SIDED|95.0|0.79|1.53|||Gray's test|One-sided test|||Reference level = placebo arm|1.53|0.79|0.289
72615807|NCT00002874|144762144|SUPERIORITY||Hazard Ratio (HR)|0.48|||<|0.001|TWO_SIDED|95.0|0.4|0.58|||Gray's test|One-sided test|Reference level = placebo arm|||0.58|0.40|<0.001
72615808|NCT00002874|144762145|SUPERIORITY||Hazard Ratio (HR)|1.11||||0.213|TWO_SIDED|95.0|0.85|1.46|||Gray's test|One-sided test|Reference level = placebo arm|||1.46|0.85|0.213
72615809|NCT00002874|144762146|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
72615810|NCT00002874|144762147|SUPERIORITY||Hazard Ratio (HR)|0.63||||0.002|TWO_SIDED|95.0|0.46|0.87|||Gray's test|One-sided test|Reference level = placebo arm|||0.87|0.46|0.002
72615811|NCT00002874|144762148|SUPERIORITY||Hazard Ratio (HR)|0.49|||<|0.001|TWO_SIDED|95.0|0.32|0.74|||Gray's test|One-sided test|Reference level = placebo arm|||0.74|0.32|<0.001
72615812|NCT00002874|144762149|SUPERIORITY||Cox Proportional Hazard|0.6|||<|0.001|TWO_SIDED|95.0|0.5|0.71|||Log Rank|One-side test|||Reference level = placebo arm|0.71|0.50|< 0.001
72615813|NCT00002874|144762150|SUPERIORITY|||||||0.06|||||||Chi-squared|||Acute radiotherapy toxicity||||0.060
72615814|NCT00002874|144762150|SUPERIORITY|||||||0.029|||||||Chi-squared|||Hormone therapy and late radiotherapy toxicity||||0.029
72615815|NCT00308685|144762158|OTHER||Difference in adjusted means|5.163||||0.0002|TWO_SIDED|95.0|2.478|7.847||Threshold for significance at 0.05 level.|ANCOVA|||Analysis was performed using an analysis of covariance (ANCOVA) with baseline FEV1 as covariate and fixed effects of pooled center and treatment group.||7.847|2.478|0.0002
72615816|NCT03158311|144762165|NON_INFERIORITY|Non-inferiority margin: 0.25 points|Least Square mean (LS Mean)|-0.038|STANDARD_ERROR_OF_MEAN|0.051|<|0.001|ONE_SIDED|97.5|-0.139|||P-Value is one-sided|Mixed Model for Repeated Measures (MMRM)||||||-0.139|<0.001
72615817|NCT03158311|144762165|NON_INFERIORITY|Non-inferiority margin: 0.25 points|LS Mean|0.073|STANDARD_ERROR_OF_MEAN|0.051|<|0.001|ONE_SIDED|97.5|-0.027|||P-Value is one-sided|MMRM||||||-0.027|<0.001
72615818|NCT03158311|144762166|SUPERIORITY||LS Mean|0.003|STANDARD_ERROR_OF_MEAN|0.025||0.892|TWO_SIDED|95.0|-0.046|0.052||P-value is two-sided|MMRM|||Week 8||0.052|-0.046|0.892
72615819|NCT03158311|144762166|SUPERIORITY||LS Mean|0.067|STANDARD_ERROR_OF_MEAN|0.025||0.007|TWO_SIDED|95.0|0.018|0.115||P-value is two-sided|MMRM|||Week 8||0.115|0.018|0.007
72615820|NCT03158311|144762166|SUPERIORITY||LS Mean|-0.002|STANDARD_ERROR_OF_MEAN|0.025||0.945|TWO_SIDED|95.0|-0.05|0.047||P-value is two-sided|MMRM|||Week 16||0.047|-0.050|0.945
72615821|NCT03158311|144762166|SUPERIORITY||LS Mean|0.066|STANDARD_ERROR_OF_MEAN|0.025||0.007|TWO_SIDED|95.0|0.018|0.114||P-value is two-sided|MMRM|||Week 16||0.114|0.018|0.007
72615822|NCT03158311|144762166|SUPERIORITY||LS Mean|0.009|STANDARD_ERROR_OF_MEAN|0.026||0.713|TWO_SIDED|95.0|-0.041|0.06||P-value is two-sided|MMRM|||Week 24||0.060|-0.041|0.713
72615823|NCT03158311|144762166|SUPERIORITY||LS Mean|0.096|STANDARD_ERROR_OF_MEAN|0.026|<|0.001|TWO_SIDED|95.0|0.046|0.146||P-value is two-sided|MMRM|||Week 24||0.146|0.046|<0.001
72432095|NCT00797225|144376623|SUPERIORITY||LS Mean Difference|-0.54|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001|TWO_SIDED|95.0|-0.73|-0.35|||Mixed-effects Repeated Measures Model|||Analysis at Week 8. The change from baseline in monthly mean sum of dysmenorrhea and non-menstrual pelvic pain scores was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.||-0.35|-0.73|< 0.0001
72615824|NCT03158311|144762167|SUPERIORITY||LS Mean|-0.023|STANDARD_ERROR_OF_MEAN|0.046||0.308|TWO_SIDED|95.0|-0.113|0.067||P-value is one-sided|MMRM|||Week 16||0.067|-0.113|0.308
72615825|NCT03158311|144762167|SUPERIORITY||LS Mean|-0.079|STANDARD_ERROR_OF_MEAN|0.046||0.044|TWO_SIDED|95.0|-0.169|0.012||P-value is one-sided|MMRM|||Week 16||0.012|-0.169|0.044
72615826|NCT03158311|144762167|SUPERIORITY||LS Mean|-0.032|STANDARD_ERROR_OF_MEAN|0.047||0.245|TWO_SIDED|95.0|-0.125|0.06||P-value is one sided|MMRM|||Week 24||0.060|-0.125|0.245
72615827|NCT03158311|144762167|SUPERIORITY||LS Mean|-0.124|STANDARD_ERROR_OF_MEAN|0.047||0.004|TWO_SIDED|95.0|-0.216|-0.032||P-value is one sided|MMRM|||Week 24||-0.032|-0.216|0.004
72615828|NCT03158311|144762168|SUPERIORITY||LS Mean|0.018|STANDARD_ERROR_OF_MEAN|0.049||0.719|TWO_SIDED|95.0|-0.079|0.115||P-value is two-sided|MMRM|||||0.115|-0.079|0.719
72615829|NCT03158311|144762168|SUPERIORITY||LS Mean|0.082|STANDARD_ERROR_OF_MEAN|0.049||0.097|TWO_SIDED|95.0|-0.015|0.179||P-value is two-sided|MMRM|||||0.179|-0.015|0.097
72615830|NCT03158311|144762169|SUPERIORITY||Odds Ratio (OR)|1.23||||0.061|TWO_SIDED|95.0|0.94|1.61||P-value is one sided|Regression, Logistic|Logistic Regression Model via Generalized estimating equations (GEE)||||1.61|0.94|0.061
72615831|NCT03158311|144762169|SUPERIORITY||Odds Ratio (OR)|1.11||||0.227|TWO_SIDED|95.0|0.85|1.46||P-value is one-sided|Regression, Logistic|Logistic Regression Model via GEE||||1.46|0.85|0.227
72615832|NCT03158311|144762170|SUPERIORITY||Odds Ratio (OR)|1.17||||0.108|TWO_SIDED|95.0|0.91|1.49||P-value is one sided|Regression, Logistic|Logistic regression model via the GEE||||1.49|0.91|0.108
72615833|NCT03158311|144762170|SUPERIORITY||Odds Ratio (OR)|1.33||||0.013|TWO_SIDED|95.0|1.03|1.7||P-Value is one sided|Regression, Logistic|Logistic regression model via the GEE||||1.70|1.03|0.013
72615834|NCT03158311|144762171|SUPERIORITY||LS Mean|-0.003|STANDARD_ERROR_OF_MEAN|0.027||0.908|TWO_SIDED|95.0|-0.055|0.049||P-Value is two-sided|MMRM|||Week 8||0.049|-0.055|0.908
72615835|NCT03158311|144762171|SUPERIORITY||LS Mean|0.053|STANDARD_ERROR_OF_MEAN|0.026||0.046|TWO_SIDED|95.0|0.001|0.104||P-Value is two-sided|MMRM|||Week 8||0.104|0.001|0.046
72615836|NCT03158311|144762171|SUPERIORITY||LS Mean|0.004|STANDARD_ERROR_OF_MEAN|0.026||0.87|TWO_SIDED|95.0|-0.047|0.056||P-Value is two-sided|MMRM|||Week 16||0.056|-0.047|0.870
72615837|NCT03158311|144762171|SUPERIORITY||LS Mean|0.058|STANDARD_ERROR_OF_MEAN|0.026||0.028|TWO_SIDED|95.0|0.006|0.109||P-Value is two-sided|MMRM|||Week 16||0.109|0.006|0.028
72615838|NCT03158311|144762171|SUPERIORITY||LS Mean|0.028|STANDARD_ERROR_OF_MEAN|0.028||0.303|TWO_SIDED|95.0|-0.026|0.083||P-Value is two-sided|MMRM|||Week 24||0.083|-0.026|0.303
72615839|NCT03158311|144762171|SUPERIORITY||LS Mean|0.095|STANDARD_ERROR_OF_MEAN|0.027|<|0.001|TWO_SIDED|95.0|0.041|0.148||P-Value is two-sided|MMRM|||Week 24||0.148|0.041|<0.001
72615840|NCT03158311|144762172|SUPERIORITY||LS Mean|0.02|STANDARD_ERROR_OF_MEAN|0.034||0.563|TWO_SIDED|95.0|-0.048|0.087||P-value is two-sided|MMRM|||Week 8||0.087|-0.048|0.563
72615841|NCT03158311|144762172|SUPERIORITY||LS Mean|0.062|STANDARD_ERROR_OF_MEAN|0.034||0.068|TWO_SIDED|95.0|-0.005|0.129||P-Value is two-sided|MMRM|||Week 8||0.129|-0.005|0.068
72615842|NCT03158311|144762172|SUPERIORITY||LS Mean|-0.007|STANDARD_ERROR_OF_MEAN|0.035||0.844|TWO_SIDED|95.0|-0.076|0.062||P-Value is two-sided|MMRM|||Week 16||0.062|-0.076|0.844
72615843|NCT03158311|144762172|SUPERIORITY||LS Mean|0.058|STANDARD_ERROR_OF_MEAN|0.035||0.097|TWO_SIDED|95.0|-0.01|0.125||P-Value is two-sided|MMRM|||Week 16||0.125|-0.010|0.097
72615844|NCT03158311|144762172|SUPERIORITY||LS Mean|0.003|STANDARD_ERROR_OF_MEAN|0.036||0.927|TWO_SIDED|95.0|-0.067|0.074||P-Value is two-sided|MMRM|||Week 24||0.074|-0.067|0.927
72615845|NCT03158311|144762172|SUPERIORITY||LS Mean|0.089|STANDARD_ERROR_OF_MEAN|0.036||0.013|TWO_SIDED|95.0|0.019|0.159||P-Value is two-sided|MMRM|||Week 24||0.159|0.019|0.013
72615846|NCT01928771|144762188|SUPERIORITY_OR_OTHER||Rate ratio|0.55|||<|0.001|TWO_SIDED|95.0|0.42|0.71|||Negative binomial|Model includes covariates treatment group, region, number of exacerbations in the previous year, and use of maintenance oral corticosteroids||||0.71|0.42|<0.001
72615847|NCT01928771|144762188|SUPERIORITY_OR_OTHER||Rate ratio|0.49|||<|0.001|TWO_SIDED|95.0|0.37|0.64|||Negative binomial|Model includes covariates treatment group, region, number of exacerbations in the previous year, and use of maintenance oral corticosteroids||||0.64|0.37|<0.001
72615848|NCT01928771|144762189|SUPERIORITY_OR_OTHER||Rate ratio|0.7||||0.047|TWO_SIDED|95.0|0.5|1.0|||Negative binomial|Model includes covariates treatment group, region, number of exacerbations in the previous year, and use of maintenance oral corticosteroids||||1.0|0.5|0.047
72615849|NCT01928771|144762189|SUPERIORITY_OR_OTHER||Rate ratio|0.83||||0.268|TWO_SIDED|95.0|0.59|1.16|||Negative binomial|Model includes covariates treatment group, region, number of exacerbations in the previous year, and use of maintenance oral corticosteroids||||1.16|0.59|0.268
72615850|NCT01928771|144762190|SUPERIORITY_OR_OTHER||Rate ratio|0.61||||0.053|TWO_SIDED|95.0|0.37|1.01|||Negative binomial|Model includes covariates treatment group, region, number of exacerbations resulting in ER/hospitalization in the previous year, and use of OCS||||1.01|0.37|0.053
72615851|NCT01928771|144762190|SUPERIORITY_OR_OTHER||Rate ratio|0.37|||<|0.001|TWO_SIDED|95.0|0.2|0.67|||Negative binomial|Model includes covariates treatment group, region, number of exacerbations resulting in ER/hospitalization in the previous year, and use of OCS||||0.67|0.2|<0.001
72615852|NCT01928771|144762191|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.54|||<|0.001|TWO_SIDED|95.0|0.37|0.78|||Cochran-Mantel-Haenszel|Controlling for region, number of exacerbations in the previous year, use of OCS||Proportion of patients with \>=1 asthma exacerbation||0.78|0.37|<0.001
72615853|NCT01928771|144762191|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.62||||0.01|TWO_SIDED|95.0|0.43|0.9|||Cochran-Mantel-Haenszel|Controlling for region, number of exacerbations from the previous year, use of OCS||Proportion of patients with \>=1 asthma exacerbation||0.90|0.43|0.01
72615854|NCT01928771|144762192|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.63|||<|0.001|TWO_SIDED|95.0|0.49|0.82|||Regression, Cox|Model includes treatment, number of exacerbations in the previous year, region, use of OCS||Time to first exacerbation||0.82|0.49|<0.001
72615855|NCT01928771|144762192|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.6|||<|0.001|TWO_SIDED|95.0|0.46|0.78|||Regression, Cox|Model includes treatment, number of exacerbations from the previous year, region, use of OCS||Time to first exacerbation||0.78|0.46|<0.001
72615856|NCT01928771|144762193|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.106||||0.022|TWO_SIDED|95.0|0.016|0.196|||Mixed Models Analysis|Model includes treatment, baseline pre-BD FEV1, region, use of OCS, visit and treatment by visit||||0.196|0.016|0.022
72615857|NCT01928771|144762193|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.159||||0.001|TWO_SIDED|95.0|0.068|0.249|||Mixed Models Analysis|Model includes treatment, baseline pre-BD FEV1, region, use of OCS, visit and treatment by visit||||0.249|0.068|0.001
72615858|NCT01928771|144762194|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.025||||0.644|TWO_SIDED|95.0|-0.134|0.083|||Mixed Models Analysis|Model includes treatment, baseline pre-BD FEV1, region, use of OCS, visit and treatment by visit||||0.083|-0.134|0.644
72615859|NCT01928771|144762194|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.102||||0.057|TWO_SIDED|95.0|-0.003|0.208|||Mixed Models Analysis|Model includes treatment, baseline pre-BD FEV1, region, use of OCS, visit and treatment by visit||||0.208|-0.003|0.057
72615860|NCT01928771|144762195|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.08||||0.442|TWO_SIDED|95.0|-0.27|0.12|||Mixed Models Analysis|Model includes treatment, baseline asthma symptom score, region, use of OCS, visit and visit by treatment||||0.12|-0.27|0.442
72615861|NCT01928771|144762195|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.25||||0.012|TWO_SIDED|95.0|-0.45|-0.06|||Mixed Models Analysis|Model includes treatment, baseline asthma symptom score, region, use of OCS, visit and visit by treatment||||-0.06|-0.45|0.012
72615862|NCT01928771|144762196|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2||||0.169|TWO_SIDED|95.0|-0.48|0.08|||Mixed Models Analysis|Model includes treatment, baseline asthma symptom score, region, use of OCS, visit and visit by treatment||||0.08|-0.48|0.169
72615863|NCT01928771|144762196|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.29||||0.043|TWO_SIDED|95.0|-0.57|-0.01|||Mixed Models Analysis|Model includes treatment, baseline asthma symptom score, region, use of OCS, visit and visit by treatment||||-0.01|-0.57|0.043
72615864|NCT01928771|144762197|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.53||||0.1|TWO_SIDED|95.0|-1.16|0.1|||Mixed Models Analysis|Model includes treatment, baseline asthma medication use, region, use of OCS, visit and visit by treatment||||0.10|-1.16|0.1
72615865|NCT01928771|144762197|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.57||||0.081|TWO_SIDED|95.0|-1.21|0.07|||Mixed Models Analysis|Model includes treatment, baseline asthma medication use, region, use of OCS, visit and visit by treatment||||0.07|-1.21|0.081
72615866|NCT01928771|144762198|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|23.32||||0.001|TWO_SIDED|95.0|9.2|37.43|||Mixed Models Analysis|Model includes treatment, baseline morning PEF, region, use of OCS, visit and visit by treatment||Morning PEF change from baseline to Week 48||37.43|9.20|0.001
72615867|NCT01928771|144762198|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.46||||0.025|TWO_SIDED|95.0|2.08|30.83|||Mixed Models Analysis|Model includes treatment, baseline morning PEF, region, use of OCS, visit and visit by treatment||Morning PEF change from baseline to Week 48||30.83|2.08|0.025
72615868|NCT01928771|144762199|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|21.75||||0.002|TWO_SIDED|95.0|7.86|35.65|||Mixed Models Analysis|Model includes treatment, baseline evening PEF, region, use of OCS, visit and visit by treatment||Evening PEF change from baseline to Week 48||35.65|7.86|0.002
72615869|NCT01928771|144762199|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|19.18||||0.008|TWO_SIDED|95.0|5.09|33.28|||Mixed Models Analysis|Model includes treatment, baseline evening PEF, region, use of OCS, visit and visit by treatment||Evening PEF change from baseline to Week 48||33.28|5.09|0.008
72615870|NCT01928771|144762200|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.964|TWO_SIDED|95.0|-0.05|0.04|||Mixed Models Analysis|Model includes treatment, baseline proportion of nights with nocturnal awakenings, region, use of OCS, visit and visit by treatment||||0.04|-0.05|0.964
72615871|NCT01928771|144762200|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.06||||0.012|TWO_SIDED|95.0|-0.11|-0.01|||Mixed Models Analysis|Model includes treatment, baseline proportion of nights with nocturnal awakenings, region, use of OCS, visit and visit by treatment||||-0.01|-0.11|0.012
72615872|NCT01928771|144762201|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.15||||0.111|TWO_SIDED|95.0|-0.34|0.04|||Mixed Models Analysis|Model includes treatment, baseline ACQ-6 score, region, use of OCS, visit and visit by treatment||||0.04|-0.34|0.111
72615873|NCT01928771|144762201|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.29||||0.003|TWO_SIDED|95.0|-0.48|-0.1|||Mixed Models Analysis|Model includes treatment, baseline ACQ-6 score, region, use of OCS, visit and visit by treatment||||-0.10|-0.48|0.003
72615874|NCT01928771|144762202|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.99|TWO_SIDED|95.0|-0.27|0.27|||Mixed Models Analysis|Model includes treatment, baseline ACQ-6 score, region, use of OCS, visit and visit by treatment||||0.27|-0.27|0.99
72615875|NCT01928771|144762202|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.22||||0.107|TWO_SIDED|95.0|-0.48|0.05|||Mixed Models Analysis|Model includes treatment, baseline ACQ-6 score, region, use of OCS, visit and visit by treatment||||0.05|-0.48|0.107
72615876|NCT01928771|144762206|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.18||||0.081|TWO_SIDED|95.0|-0.02|0.37|||Mixed Models Analysis|Model includes covariates treatment, baseline AQLQ(S)+12 score, region, use of OCS, visit, and visit by treatment||||0.37|-0.02|0.081
72615877|NCT01928771|144762206|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3||||0.004|TWO_SIDED|95.0|0.1|0.5|||Mixed Models Analysis|Model includes covariates treatment, baseline AQLQ(S)+12 score, region, use of OCS, visit, and visit by treatment||||0.5|0.1|0.004
72615878|NCT01271855|144762258|SUPERIORITY||Z-Score|0.93||||0.35|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||The z-score is a standardized version of the Wilcoxon test statistic. In this study, z-scores with an absolute value exceeding 1.96 signal the two groups have meaningfully different pain scores. Other values would fail to reject the null hypothesis.|The null hypothesis is that there is no difference in the visual analogue pain score scale (VAS) between participants in the Glycerin suppository group and those in the Belladonna and opioid suppository group 24-hours after delivery.||||.35
72615879|NCT01271855|144762259|SUPERIORITY||Odds Ratio (OR)|1.88||||0.3|TWO_SIDED|95.0|0.57|6.21|||Regression, Logistic|||The null hypothesis is that there is no difference in the odds of taking additional pain medications between participants in the Glycerin suppository group and those in the Belladonna and opioid suppository group 24-hours after delivery.||6.21|0.57|.30
72615880|NCT01271855|144762260|SUPERIORITY||Z-Score|2.34||||0.02|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||The z-score is a standardized version of the Wilcoxon test statistic. In this study, z-scores with an absolute value exceeding 1.96 signal the two groups have meaningfully different satisfaction scores. Other values fail to reject the null hypothesis|The null hypothesis is that there is no difference in the pain satisfaction score between participants in the Glycerin suppository group and those in the Belladonna and opioid suppository group at discharge||||.02
72615881|NCT01407367|144762264|OTHER||Hazard Ratio (HR)|0.38||||0.04|TWO_SIDED|95.0|0.16|0.94||calculated p-value. Results adjusted for gender, race, age, BMI, MAP, eGFR, smoking history, diabetes, hypertension, cardiovascular disease, cancer, education employment status, health literacy and RAAS use.|Regression, Cox|||||0.94|0.16|.04
72615882|NCT01407367|144762265|OTHER||Hazard Ratio (HR)|1.03||||0.86|TWO_SIDED|95.0|0.53|1.99||calculated p-value. Results adjusted for gender, race, age, BMI, MAP, eGFR, smoking history, diabetes, hypertension, cardiovascular disease, cancer, education employment status, health literacy and RAAS use.|Regression, Cox|||||1.99|0.53|0.86
72615883|NCT01452347|144762266|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean ratio|74.22|STANDARD_ERROR_OF_MEAN|1.05||||95.0|68.08|80.91|||ANOVA|The Ctrough,ss (predicted or observed) was log transformed (natural logarithm) prior to fitting the ANOVA model.|"The standard error of the mean is actually the geometric standard error.~(Observed vs Predicted)"|"Null hypothesis: The difference of the population average responses was either ≤ to the lower bound or ≥ to the upper bound of the acceptance range .~Alternative hypothesis: The difference of the population average responses was both \> than the lower bound and \< than the upper bound of the acceptance range \[Note: The acceptance range for the geometric mean is 80-125%\]"||80.91|68.08|
72615884|NCT01452347|144762267|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean ratio|84.46|STANDARD_ERROR_OF_MEAN|1.11||||95.0|70.32|101.44|||ANOVA|The Ctrough,ss (predicted or observed) was log transformed (natural logarithm) prior to fitting the ANOVA model.|"The standard error of the mean is actually the geometric standard error.~(Observed vs Predicted)"|"Null hypothesis: The difference of the population average responses was either ≤ to the lower bound or ≥ to the upper bound of the acceptance range .~Alternative hypothesis: The difference of the population average responses was both \> than the lower bound and \< than the upper bound of the acceptance range \[Note: The acceptance range for the geometric mean is 80-125%\]"||101.44|70.32|
72432096|NCT00797225|144376623|SUPERIORITY||LS Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.1||0.1319|TWO_SIDED|95.0|-0.34|0.04|||Mixed-effects Repeated Measures Model|||Analysis at Week 12. The change from baseline in monthly mean sum of dysmenorrhea and non-menstrual pelvic pain scores was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.||0.04|-0.34|0.1319
72615885|NCT01452347|144762268|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean ratio|95.5|STANDARD_ERROR_OF_MEAN|1.05||||95.0|88.69|102.84|||ANOVA|The Ctrough,ss (predicted or observed) was log transformed (natural logarithm) prior to fitting the ANOVA model.|"The standard error of the mean is actually the geometric standard error.~(Observed vs Predicted)"|"Null hypothesis: The difference of the population average responses was either ≤ to the lower bound or ≥ to the upper bound of the acceptance range .~Alternative hypothesis: The difference of the population average responses was both \> than the lower bound and \< than the upper bound of the acceptance range \[Note: The acceptance range for the geometric mean is 80-125%\]"||102.84|88.69|
72615886|NCT01452347|144762269|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean ratio|103.25|STANDARD_ERROR_OF_MEAN|1.11||||95.0|86.4|123.4|||ANOVA|The Ctrough,ss (predicted or observed) was log transformed (natural logarithm) prior to fitting the ANOVA model.|"The standard error of the mean is actually the geometric standard error.~(Observed vs Predicted)"|"Null hypothesis: The difference of the population average responses was either ≤ to the lower bound or ≥ to the upper bound of the acceptance range .~Alternative hypothesis: The difference of the population average responses was both \> than the lower bound and \< than the upper bound of the acceptance range \[Note: The acceptance range for the geometric mean is 80-125%\]"||123.40|86.40|
72615887|NCT01452347|144762270|SUPERIORITY_OR_OTHER||||||<|0.001||||||Probability that P remains \< 10% are presented, where P=Percentage of patients with observed Ctrough,ss value \< 50 ng/mL|Beta Function|Probability calculated using Beta function \~B(1 + r, 1 + n - r),r=no. of patients(observed Ctrough,ss value \< 50 ng/mL), n=no. of patients evaluated||||||<0.001
72554915|NCT04278560|144641733|SUPERIORITY||Mean Difference (Net)|0.19||||0.4|TWO_SIDED||||||ANOVA|We used change from baseline for the analysis. Two-Way Repeated Measure ANOVA: Group, Time, Group x Time, and controlled baseline.||||||0.4
72615888|NCT01452347|144762271|SUPERIORITY_OR_OTHER|||||||0.05||||||Probability that P remains \< 10% are presented, where P=Percentage of patients with observed Ctrough,ss value \< 50 ng/mL|Beta Function|Probability calculated using Beta function \~B(1 + r, 1 + n - r),r=no. of patients(observed Ctrough,ss value \< 50 ng/mL), n=no. of patients evaluated||||||0.05
72615889|NCT01452347|144762272|SUPERIORITY_OR_OTHER|||||||0.46||||||Probability that P remains \< 10% are presented, where P=Percentage of patients with observed Ctrough,ss value \< 50 ng/mL|Beta Function|Probability calculated using Beta function \~B(1 + r, 1 + n - r),r=no. of patients(observed Ctrough,ss value \< 50 ng/mL), n=no. of patients evaluated||||||0.46
72615890|NCT01452347|144762273|SUPERIORITY_OR_OTHER|||||||0.65||||||Probability that P remains \< 10% are presented, where P=Percentage of patients with observed Ctrough,ss value \< 50 ng/mL|Beta Function|Probability calculated using Beta function \~B(1 + r, 1 + n - r),r=no. of patients(observed Ctrough,ss value \< 50 ng/mL), n=no. of patients evaluated||||||0.65
72615891|NCT02642679|144762274|OTHER|We set alpha=0.05/3=0.17 to account for multiple outcomes for sample size and power calculations. With 10 patients in each group, we had 95% power to detect an improvement of 2 points in VAS score assuming a common standard deviation of 1 point with a two sided two sample t-test each at alpha=0.17 level.|||||||||||||||||A student t-test was used for correlated samples to determine if there were significant differences in pain. Microsoft Excel 2010 (Microsoft Corp., Redmond, WA) was used for statistical analysis. Data that were considered normally distributed are reported as the mean ± standard deviation (SD) and percentage. P-values \<0.05 were considered significant.|||
72615892|NCT02642679|144762275|OTHER|We set alpha=0.05/3=0.17 to account for multiple outcomes for sample size and power calculations. With 10 patients in each group, we will have 80% power to detect an improvement in re-epithelialization from 14.6 days to 10 days assuming a common standard deviation of 2.9 days.|||||||||||||||||A student t-test was used for correlated samples to determine if there were significant differences in healing rate. Microsoft Excel 2010 (Microsoft Corp., Redmond, WA) was used for statistical analysis. Data that were considered normally distributed are reported as the mean ± standard deviation (SD) and percentage. P-values \<0.05 were considered significant.|||
72615893|NCT02642679|144762276|OTHER|We set alpha=0.05/3=0.17 to account for multiple outcomes for sample size and power calculations. With 10 patients in each group, we will have 95% power to detect an improvement of 2 points in VSS score assuming a common standard deviation of 1 point.|||||||||||||||||A student t-test was used for correlated samples to determine if there were significant differences in healing quality. Microsoft Excel 2010 (Microsoft Corp., Redmond, WA) was used for statistical analysis. Data that were considered normally distributed are reported as the mean ± standard deviation (SD) and percentage. P-values \<0.05 were considered significant.|||
72615894|NCT01112267|144762279|SUPERIORITY_OR_OTHER|||||||0.0367|||||||Cochran-Mantel-Haenszel|p-value for percentage of participants with reduction in pain intensity was calculated for tramadol HCl/acetaminophen and placebo groups||||||0.0367
72615895|NCT01112267|144762280|SUPERIORITY_OR_OTHER|||||||0.0095||||||p-value for change in reduction in pain intensity at Day 29 was calculated for tramadol HCl/acetaminophen and placebo groups|Mann-Whitney U test|||||||0.0095
72615896|NCT01112267|144762281|SUPERIORITY_OR_OTHER|||||||0.0202||||||p-value for percentage of participants with pain relief at Day 8 was calculated for tramadol HCl/acetaminophen and placebo groups|Chi-squared|||||||0.0202
72615897|NCT01112267|144762281|SUPERIORITY_OR_OTHER|||||||0.0102||||||p-value for percentage of participants with pain relief at Day 15 was calculated for tramadol HCl/acetaminophen and placebo groups|Chi-squared|||||||0.0102
72615898|NCT01112267|144762281|SUPERIORITY_OR_OTHER|||||||0.4652||||||p-value for percentage of participants with pain relief at Day 29 was calculated for tramadol HCl/acetaminophen and placebo groups|Chi-squared|||||||0.4652
72615899|NCT01112267|144762282|SUPERIORITY_OR_OTHER|||||||0.3524||||||p-value for change from Baseline in physical conditioning at Day 29 was calculated using for tramadol HCl/acetaminophen and placebo groups|Wilcoxon (Mann-Whitney)|||||||0.3524
72615900|NCT01112267|144762282|SUPERIORITY_OR_OTHER|||||||0.0224||||||p-value for change from Baseline in role physical at Day 29 was calculated for tramadol HCl/acetaminophen and placebo groups.|Wilcoxon (Mann-Whitney)|||||||0.0224
72615901|NCT01112267|144762282|SUPERIORITY_OR_OTHER|||||||0.5712||||||p-value for change from Baseline in bodily pain at Day 29 was calculated for tramadol HCl/acetaminophen and placebo groups.|Wilcoxon (Mann-Whitney)|||||||0.5712
72615902|NCT01112267|144762282|SUPERIORITY_OR_OTHER|||||||0.0395||||||p-value for change from Baseline in general health at Day 29 was calculated for tramadol HCl/acetaminophen and placebo groups.|Wilcoxon (Mann-Whitney)|||||||0.0395
72615903|NCT01112267|144762282|SUPERIORITY_OR_OTHER|||||||0.0524||||||p-value for change from Baseline in vitality at Day 29 was calculated for tramadol HCl/acetaminophen and placebo groups.|Wilcoxon (Mann-Whitney)|||||||0.0524
72615904|NCT01112267|144762282|SUPERIORITY_OR_OTHER|||||||0.115||||||p-value for change from Baseline in social functioning at Day 29 was calculated using for tramadol HCl/acetaminophen and placebo groups.|Wilcoxon (Mann-Whitney)|||||||0.115
72615905|NCT01112267|144762282|SUPERIORITY_OR_OTHER|||||||0.7788||||||p-value for change from Baseline in role emotional at Day 29 was calculated for tramadol HCl/acetaminophen and placebo groups.|Wilcoxon (Mann-Whitney)|||||||0.7788
72615906|NCT01112267|144762282|SUPERIORITY_OR_OTHER|||||||0.7776||||||p-value for change from Baseline in mental health at Day 29 was calculated for tramadol HCl/acetaminophen and placebo groups.|Wilcoxon (Mann-Whitney)|||||||0.7776
72615907|NCT01112267|144762282|SUPERIORITY_OR_OTHER|||||||0.0047||||||p-value for change from Baseline in Reptd. health transition at Day 29 was calculated for tramadol HCl/acetaminophen and placebo groups.|Wilcoxon (Mann-Whitney)|||||||0.0047
72615908|NCT01112267|144762283|SUPERIORITY_OR_OTHER|||||||0.0527||||||p-value for change from Baseline in ODI- Korean version at Day 29 was calculated for tramadol HCl/acetaminophen and placebo groups.|Wilcoxon (Mann-Whitney)|||||||0.0527
72615909|NCT01112267|144762284|SUPERIORITY_OR_OTHER|||||||0.0917||||||p-value for investigator's global assessment on investigational product at Day 29 was calculated for tramadol HCl/acetaminophen and placebo groups.|Chi-squared|||||||0.0917
72615910|NCT01112267|144762285|SUPERIORITY_OR_OTHER|||||||0.5632||||||p-value for participant's global assessment on investigational product at Day 29 was calculated for tramadol HCl/acetaminophen and placebo groups.|Chi-squared|||||||0.5632
72615911|NCT05638737|144762298|SUPERIORITY|One-sided test where a negative change in relative to baseline is favourable|%-change in relative to base vs placebo|7.5||||0.893|TWO_SIDED|95.0|-4.1|20.5|||Mixed Models Analysis|Participant as random effect; treatment, visit and trt:vis interaction as fixed effects; baseline ALT as covariate. Model uses log-scaled variables.||||20.5|-4.1|0.893
72615912|NCT05638737|144762299|SUPERIORITY|One-sided test where a negative change in relative to baseline is favourable|%-change in relative to base vs placebo|-0.9||||0.396|TWO_SIDED|95.0|-7.5|6.1|||Mixed Models Analysis|Participant as random effect; treatment, visit and trt:vis interaction as fixed effects; baseline Pro-C3 as covariate. Model uses log-scaled variables||||6.1|-7.5|0.396
72615913|NCT04333498|144762304|OTHER||Mean Difference (Net)|-221.03||||0.014|TWO_SIDED|95.0|-396.33|-45.73|||t-test, 2 sided|||||-45.73|-396.33|.014
72615914|NCT04333498|144762305|OTHER||Mean Difference (Net)|1103.96||||0.122|TWO_SIDED|95.0|-296.532|2502.722|||t-test, 2 sided|||||2502.722|-296.532|0.122
72615915|NCT04333498|144762306|OTHER||Mean Difference (Net)|-2.61||||0.218|TWO_SIDED|95.0|-8.614|3.391|||t-test, 2 sided|||Adherence percentage||3.391|-8.614|.218
72615916|NCT04333498|144762306|OTHER|Linear regression with generalized estimating equations (GEE)|Slope|0.046||||0.272|TWO_SIDED|95.0|-0.036|0.128|||Regression, Linear|||||0.128|-0.036|0.272
72615917|NCT01565694|144762307|OTHER|P-Value was from a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.|||||<|0.001|||||||t-test, 2 sided|||Analysis of change from baseline to Week 24.||||<0.001
72615918|NCT01565694|144762307|OTHER|P-Value was from a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.|||||<|0.001|||||||t-test, 2 sided|||Analysis of change from baseline to Week 24 LOCF.||||<0.001
72615919|NCT01565694|144762308|OTHER|P-Value was obtained from a 2-sided one sample t-test, testing the null hypothesis that Change from Baseline=0.|||||<|0.001|||||||t-test, 2 sided|||||||<0.001
72615920|NCT01565694|144762309|OTHER|P-Value was from a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.||||||0.029|||||||t-test, 2 sided|||Analysis of change from baseline to Week 24.||||0.029
72615921|NCT01565694|144762309|OTHER|P-Value was from a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.||||||0.026|||||||t-test, 2 sided|||Analysis of change from baseline to Week 24 LOCF.||||0.026
72615922|NCT01565694|144762310|OTHER|From a Wilcoxon Signed Rank testing the null hypothesis is that the Median at Week 24 is equal to Baseline Median.|||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Analysis of change from baseline to Week 24.||||<0.001
72615923|NCT01565694|144762311|OTHER|P-Value was calculated from a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0||||||0.006|||||||t-test, 2 sided|||Analysis of change from baseline to Week 24 in bladder volume at 30 cmH20.||||0.006
72432097|NCT00797225|144376623|SUPERIORITY||LS Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.1||0.0222|TWO_SIDED|95.0|-0.42|-0.03|||Mixed-effects Repeated Measures Model|||Analysis at Week 12. The change from baseline in monthly mean sum of dysmenorrhea and non-menstrual pelvic pain scores was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.||-0.03|-0.42|0.0222
72615924|NCT01565694|144762311|OTHER|P-Value was calculated from a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.||||||0.001|||||||t-test, 2 sided|||Analysis of change from baseline to Week 24 LOCF in bladder volume at 30 cmH20.||||0.001
72615925|NCT01565694|144762312|OTHER|P-Value was calculated from a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0||||||0.001|||||||t-test, 2 sided|||Analysis of change from baseline to week 24 in bladder volume at 40 cmH20.||||0.001
72554916|NCT04278560|144641734|SUPERIORITY||Mean Difference (Net)|3.1||||0.016|TWO_SIDED||||||ANOVA|We used change from baseline for this analysis. Two-Way Repeated Measure ANOVA: Group, Time, Group x Time, and controlled baseline.||||||0.016
72615926|NCT01565694|144762312|OTHER|P-Value was calculated from a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0||||||0.004|||||||t-test, 2 sided|||Analysis of change from baseline to week 24 LOCF in bladder volume at 40 cmH20.||||0.004
72615927|NCT01565694|144762313|OTHER|P-Value was calculated from a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0||||||0.003|||||||t-test, 2 sided|||Analysis of change from baseline to Week 24.||||0.003
72615928|NCT01565694|144762313|OTHER|P-Value was calculated from a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0||||||0.028|||||||t-test, 2 sided|||Analysis of change from baseline to Week 24 LOCF.||||0.028
72615929|NCT01565694|144762314|OTHER|P-Value was calculated from a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.||||||0.068|||||||t-test, 2 sided|||Analysis of change from baseline to Week 24.||||0.068
72615930|NCT01565694|144762314|OTHER|P-Value was calculated from a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.||||||0.075|||||||t-test, 2 sided|||Analysis of change from baseline to Week 24 LOCF.||||0.075
72615931|NCT01565694|144762315|OTHER|P-Value was calculated from a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.|||||<|0.001|||||||t-test, 2 sided|||Analysis of change from baseline to Week 24.||||<0.001
72615932|NCT01565694|144762315|OTHER|P-Value was calculated from a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.|||||<|0.001|||||||t-test, 2 sided|||Analysis of change from baseline to Week 24 LOCF.||||<0.001
72615933|NCT01565694|144762316|OTHER|P-Value was calculated from a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0|||||<|0.001|||||||t-test, 2 sided|||Analysis of change from baseline to Week 24.||||<0.001
72615934|NCT01565694|144762316|OTHER|P-Value was calculated from a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0|||||<|0.001|||||||t-test, 2 sided|||Analysis of change from baseline to Week 24 LOCF.||||<0.001
72615935|NCT01565694|144762317|OTHER|P-Value was calculated from a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.|||||<|0.001|||||||t-test, 2 sided|||Analysis of change from baseline to Week 24.||||<0.001
72615936|NCT01565694|144762317|OTHER|P-Value was calculated from a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.|||||<|0.001|||||||t-test, 2 sided|||Analysis of change from baseline to Week 24 LOCF.||||<0.001
72615937|NCT01565694|144762318|OTHER|P-Value was calculated from a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.|||||<|0.001|||||||t-test, 2 sided|||Analysis of change from baseline to Week 24.||||<0.001
72615938|NCT01565694|144762318|OTHER|P-Value was calculated from a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.|||||<|0.001|||||||t-test, 2 sided|||Analysis of change from baseline to Week 24 LOCF.||||<0.001
72615939|NCT01565694|144762319|OTHER|P-Value was calculated from a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.||||||0.01|||||||t-test, 2 sided|||Analysis of change from baseline to Week 24.||||0.010
72615940|NCT01565694|144762319|OTHER|P-Value was calculated from a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.||||||0.004|||||||t-test, 2 sided|||Analysis of change from baseline to Week 24 LOCF.||||0.004
72615941|NCT01565694|144762320|OTHER|P-Value was calculated from a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.|||||<|0.001|||||||t-test, 2 sided|||Analysis of change from baseline to Week 24.||||<0.001
72615942|NCT01565694|144762320|OTHER|P-Value was calculated from a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.|||||<|0.001|||||||t-test, 2 sided|||Analysis of change from baseline to Week 24 LOCF.||||<0.001
72615943|NCT01565694|144762321|OTHER|P-Value was calculated from a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.||||||0.568|||||||t-test, 2 sided|||Analysis of change from baseline to Week 24.||||0.568
72615944|NCT01565694|144762321|OTHER|P-Value was calculated from a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.||||||0.573|||||||t-test, 2 sided|||Analysis of change from baseline to Week 24 LOCF.||||0.573
72615945|NCT06059066|144762331|OTHER|||||||0.57||||||Threshold for statistical significance used P-value \<0.05|t-test, 2 sided|||Willingness to repeat procedure immediately after received intradetrusor BTX-A injections||||0.57
72615946|NCT06059066|144762331|OTHER|||||||0.83||||||Threshold for statistical significance used P-value \<0.05|t-test, 2 sided|||Willingness to repeat procedure asses 6-weeks after intradetrusor BTX-A injections||||0.83
72615947|NCT06059066|144762332|OTHER|||||||0.59||||||Threshold for statistical significance used P-value \<0.05|t-test, 2 sided|||Difference in total ICIQ-SF score assessed before and 6-weeks after treatment||||0.59
72615948|NCT06059066|144762332|OTHER|||||||0.29||||||Threshold for statistical significance used P-value \<0.05|t-test, 2 sided|||Difference in ICIQ QoL score assessed before and 6-weeks after treatment||||0.29
72615949|NCT06059066|144762333|OTHER|||||||0.57||||||Threshold for statistical significance used P-value \<0.05|t-test, 2 sided|||Difference in total NBSS-SF score assessed before and 6-weeks after treatment||||0.57
72615950|NCT06059066|144762333|OTHER|||||||0.42||||||Threshold for statistical significance used P-value \<0.05|t-test, 2 sided|||Difference in NBSS-SF QoL score assessed before and 6-weeks after treatment||||0.42
72615951|NCT06059066|144762333|OTHER|||||||0.24||||||Threshold for statistical significance used P-value \<0.05|t-test, 2 sided|||Difference in NBSS-SF incontinence domain score assessed before and 6-weeks after treatment||||0.24
72615952|NCT06059066|144762333|OTHER|||||||0.93||||||Threshold for statistical significance used P-value \<0.05|t-test, 2 sided|||Difference in NBSS-SF storage and voiding domain score assessed before and 6-weeks after treatment||||0.93
72615953|NCT06059066|144762333|OTHER|||||||0.64||||||Threshold for statistical significance used P-value \<0.05|t-test, 2 sided|||Difference in NBSS-SF consequences domain score assessed before and 6-weeks after treatment||||0.64
72432098|NCT00797225|144376623|SUPERIORITY||LS Mean Difference|-0.47|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001|TWO_SIDED|95.0|-0.66|-0.28|||Mixed-effects Repeated Measures Model|||Analysis at Week 12. The change from baseline in monthly mean sum of dysmenorrhea and non-menstrual pelvic pain scores was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.||-0.28|-0.66|< 0.0001
72615954|NCT06059066|144762334|OTHER|||||||0.21||||||Threshold for statistical significance used P-value \<0.05|t-test, 2 sided|||||||0.21
72615955|NCT06059066|144762335|OTHER||||||<|2e-05||||||Threshold for statistical significance used P-value \<0.05|t-test, 2 sided|||Change in post-procedural pain as compared to baseline||||<0.00002
72615956|NCT00541229|144762336|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-31.8||||0.004||95.0|-53.1|-10.5|||ANOVA|Model term: treatment||For this comparison, the mean in the placebo group was subtracted from the mean in the sitagliptin 200 mg group.||-10.5|-53.1|0.004
72615957|NCT00541229|144762336|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-41.9|||<|0.001||95.0|-63.6|-20.2|||ANOVA|Model term: treatment||For this comparison, the mean in the placebo group was subtracted from the mean in the sitagliptin 100 mg group.||-20.2|-63.6|<0.001
72615958|NCT00541229|144762336|NON_INFERIORITY_OR_EQUIVALENCE|The hypothesis stated that the lower bound of 80% one-sided confidence interval for the comparison in 24-hour WMG reduction between sitagliptin 200 mg and sitagliptin 100 mg is above -5 mg/dL.|Mean Difference (Final Values)|10.1||||||80.0|0.61|9999999.0|||||This is a 1-sided 80% confidence interval and the upper bound 9999999 was used here to indicate positive infinity.|This was pre-defined as a non-superiority test, i.e., to show that sitagliptin 200 mg is not superior to sitagliptin 100 mg. For this comparison, the mean in the sitagliptin 100 mg group was subtracted from the mean in the sitagliptin 200 mg group.||9999999|0.61|
72615959|NCT01807520|144762337|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-26.7|STANDARD_ERROR_OF_MEAN|6.26|<|0.0001|TWO_SIDED|95.0|-39.1|-14.3|||Mixed model reapeated measures|||||-14.3|-39.1|<0.0001
72615960|NCT01807520|144762337|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-34.4|STANDARD_ERROR_OF_MEAN|5.47|<|0.0001|TWO_SIDED|95.0|-45.2|-23.5|||Mixed model repeated measures|||||-23.5|-45.2|<0.0001
72615961|NCT00421733|144762362|SUPERIORITY_OR_OTHER|||||||0.071||||||There were no P-value adjustments for multiple comparisons.|ANCOVA|1-way ANCOVA using treatment group as the factor and baseline FMV UACR as the covariate.||||||0.071
72615962|NCT00421733|144762362|SUPERIORITY_OR_OTHER|||||||0.229||95.0||||There were no P-value adjustments for multiple comparisons.|ANCOVA|1-way ANCOVA with treatment group as the factor and baseline FMV UACR as the covariate.||||||0.229
72615963|NCT00421733|144762362|SUPERIORITY_OR_OTHER|||||||0.053||95.0||||There were no P-value adjustments for multiple comparisons.|ANCOVA|1-way ANCOVA using treatment group as the factor and baseline FMV UACR as the covariate.||||||0.053
72615964|NCT00421733|144762363|SUPERIORITY_OR_OTHER|||||||0.102||95.0|||||Fisher Exact|||||||0.102
72615965|NCT00421733|144762363|SUPERIORITY_OR_OTHER|||||||0.038||95.0|||||Fisher Exact|||||||0.038
72615966|NCT00421733|144762364|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.02||||0.855|TWO_SIDED|95.0|-0.26|0.22|||ANCOVA|2-way ANCOVA: baseline UACR as covariate; fixed factors for treatment group, stratification level, and treatment by stratification level interaction||||0.22|-0.26|0.855
72615967|NCT00421733|144762364|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.33||||0.009|TWO_SIDED|95.0|-0.57|-0.08|||ANCOVA|2-way ANCOVA: baseline UACR as covariate; fixed factors for treatment group, stratification level, and treatment by stratification level interaction||||-0.08|-0.57|0.009
72432099|NCT02408965|144376643|SUPERIORITY|||||||0.5|||||||Chi-squared|||||||0.5
72432100|NCT02408965|144376644|SUPERIORITY|||||||0.02|||||||t-test, 2 sided|||||||0.02
72432101|NCT02408965|144376645|SUPERIORITY|||||||0.04|||||||Chi-squared|||||||0.04
72432102|NCT02408965|144376646|SUPERIORITY|||||||0.06|||||||Chi-squared|||||||0.06
72615968|NCT00421733|144762365|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|1-way ANCOVA with treatment group as the factor and baseline iPTH as covariate.||||||<0.001
72615969|NCT00421733|144762365|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|1-way ANCOVA with treatment group as the factor and baseline iPTH as covariate.||||||<0.001
72615970|NCT02810327|144762374|OTHER|||||||0.054|||||||Wilcoxon (Mann-Whitney)|||The MUSC Bioinformatics Core analyzed group genomic data for variant association with COPD severity score, including single variant association or type of variant association with symptoms. Descriptive statistical analysis was performed using statistical package SAS 9.4 for Windows (SAS Institute Inc., Cary, NC, USA).||||0.054
72615971|NCT02265744|144762375|SUPERIORITY|||||||0.9745|||||||Chi-squared|Nominal p-values that are not adjusted for multiplicity.||||||0.9745
72615972|NCT02265744|144762375|SUPERIORITY|||||||0.6217|||||||Chi-squared|Nominal p-values that are not adjusted for multiplicity.||||||0.6217
72615973|NCT02265744|144762375|SUPERIORITY|||||||0.8295|||||||Chi-squared|Nominal p-values that are not adjusted for multiplicity.||||||0.8295
72615974|NCT02265744|144762375|SUPERIORITY|||||||0.9439|||||||Chi-squared|Nominal p-values that are not adjusted for multiplicity.||||||0.9439
72615975|NCT00299221|144762413|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2|STANDARD_DEVIATION|0.4||0.44||95.0|||||t-test, 2 sided|||comparing ISHLT biopsy score between groups at 1 year||||0.44
72615976|NCT01086475|144762417|SUPERIORITY_OR_OTHER|||||||0.45|TWO_SIDED||||||t-test, 2 sided|||||||0.45
72615977|NCT01086475|144762418|SUPERIORITY_OR_OTHER|||||||0.927|||||||Chi-squared|||||||0.927
72615978|NCT01086475|144762419|SUPERIORITY_OR_OTHER|||||||0.048|TWO_SIDED||||||t-test, 2 sided|||||||0.048
72615979|NCT00505362|144762444|SUPERIORITY_OR_OTHER|||||||0.04|||||||t-test, 2 sided|||||||0.04
72615980|NCT00505362|144762445|SUPERIORITY_OR_OTHER|||||||0.61|||||||t-test, 2 sided|||||||0.61
72615981|NCT02384460|144762446|OTHER||Hazard Ratio (HR)|1.004||||0.985|TWO_SIDED|95.0|0.651|1.549||p-value is for Type 3 chi-square test for comparison between treatments.|Cox Model Analysis|||Cox proportional hazards model compares treatment groups with baseline target wound size, target wound age, and EB type as covariates.||1.549|0.651|0.985
72615982|NCT02384460|144762447|OTHER|Multiple imputation was implemented by 2 steps. The first step used Markov Chain Monte Carlo (MCMC) to get monotonic missing data pattern. In the second step, a logistic regression model was used, with the following covariates included in the imputation model: treatment, EB type, baseline target wound size, target wound age, and non-missing data from earlier time points. The seed number was 010005 and the number of imputations was 5.|Odds Ratio (OR)|0.733||||0.39|TWO_SIDED|95.0|0.365|1.474||p-value is from the logistic regression model for treatment comparison.|Regression, Logistic|||Comparison between treatment groups of complete closure of target wound within 3 months was performed using a logistic regression model with multiple imputation with EB type, baseline target wound size, and baseline target wound age as covariates.||1.474|0.365|0.39
72615983|NCT02384460|144762448|OTHER|Multiple imputation was implemented by 2 steps. The first step used MCMC to get the monotonic missing data pattern. In the second step, a logistic regression model was used, with the following covariates included in the imputation method: treatment, EB type, baseline target wound size, target wound age, and non-missing data from earlier time points. The seed number was 01005 and the number of imputations was 5.|Odds Ratio (OR)|1.633||||0.212|TWO_SIDED|95.0|0.758|3.517||p-value is from the logistic regression model for treatment comparison.|Regression, Logistic|||Logistic Regression Analysis at Month 1 visit. Comparison between treatment groups of complete closure of target wound within 1 month was performed using a logistic regression model with multiple imputation with EB type, baseline target wound size, and baseline target wound age as covariates.||3.517|0.758|0.212
72615984|NCT02384460|144762448|OTHER|Multiple imputation was implemented by 2 steps. The first step used MCMC to get monotonic missing data pattern. In the second step, a logistic regression model was used, with the following covariates included in the imputation model: treatment, EB type, baseline target wound size, target wound age, and non-missing data from earlier time points. The seed number was 01005 and the number of imputations was 5.|Odds Ratio (OR)|0.891||||0.802|TWO_SIDED|95.0|0.436|1.821||p-value is from the logistic regression model for treatment comparison.|Regression, Logistic|||Logistic Regression Analysis at Month 2 visit. Comparison between treatment groups of complete closure of target wound within 2 months was performed using a logistic regression model with multiple imputation with EB type, baseline target wound size, and baseline target wound age as covariates.||1.821|0.436|0.802
72615985|NCT02384460|144762449|OTHER|Multiple imputation was used by 2 steps. The first step used MCMC to get monotonic missing data pattern. In the second step, a linear regression model was used, with the following covariates included in the imputation model: treatment, EB type, baseline BSAI of lesional skin, and non-missing data from earlier time points. The seed number was 01005 and the number of imputations was 5.|LS means difference|0.682||||0.706|TWO_SIDED|95.0|-2.873|4.238||The p-value is calculated based on the hypothesis testing for the difference of least-squares (LS)-means between treatment and placebo.|Mixed Models Analysis|||Mixed Model Repeated Measures (MMRM) Analysis. The MMRM approach (using restricted maximum likelihood \[REML\] estimation) was used on each multiply-imputed data set. The model included treatment, baseline BSAI of lesional skin, EB type, visit, and visit-treatment interaction as the fixed effects.||4.238|-2.873|0.706
72615986|NCT02384460|144762450|OTHER|Multiple imputation was used by 2 steps. The first step used MCMC to get monotonic missing data pattern. In the second step, a linear regression model was used, with the following covariates included in the imputation model: treatment, EB type, baseline BSAI of lesional skin, and non-missing data from earlier time points. The seed number was 01005 and the number of imputations was 5.|LS means difference|0.128||||0.9|TWO_SIDED|95.0|-2.116|1.861||The p-value is calculated based on the hypothesis testing for the difference of LS-means between treatment and placebo.|Mixed Models Analysis|||MMRM Analysis. The MMRM approach (using REML estimation) was used on each multiply-imputed data set. The model included treatment, baseline BSAI of lesional skin, EB type, visit, and visit-treatment interaction as the fixed effects.||1.861|-2.116|0.9
72615987|NCT02384460|144762451|OTHER|Pre-specified.|Odds Ratio (OR)|1.445||||0.262|TWO_SIDED|95.0|0.759|2.752||p-value is from the logistic regression model for treatment comparison.|Regression, Logistic|||The proportion of participants experiencing improvement in itching versus non-improvement (including missing) was compared between the 2 treatment groups for Day 7 using the logistic regression model with baseline itching score, and EB type as covariates.||2.752|0.759|0.262
72615988|NCT02384460|144762452|OTHER|Pre-specified.|Odds Ratio (OR)|0.596||||0.098|TWO_SIDED|95.0|0.323|1.1||p-value is from the logistic regression model for treatment comparison.|Regression, Logistic|||The proportion of participants experiencing improvement in pain versus non-improvement (including missing) was compared between the 2 treatment groups for Day 7 using the logistic regression model with baseline pain score and EB type as covariates.||1.1|0.323|0.098
72615989|NCT01060111|144762453|SUPERIORITY_OR_OTHER|||||||0.6207|||||||ANOVA|Analysis of Variance (ANOVA) for treatment groups (Topiramate standard, Topiramate slow, Topiramate slow and Propranolol booster) was used.||||||0.6207
72615990|NCT01060111|144762453|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferioirity was to be concluded if the ratio of percentage decrease in migraine episodes was greater than 0.7. Power of calculation was 0.9, significance level was 0.025.|Ratio of percentage decrease|0.95||||0.5|TWO_SIDED|95.0|0.519|1.737|||t-test, 1 sided|||||1.737|0.519|0.5
72615991|NCT01060111|144762454|SUPERIORITY_OR_OTHER|||||||0.7247|||||||ANOVA|Analysis of Variance (ANOVA) for treatment groups (Topiramate standard, Topiramate slow, Topiramate slow and Propranolol booster) was used.||||||0.7247
72615992|NCT01060111|144762455|SUPERIORITY_OR_OTHER|||||||0.9872|||||||ANOVA|Analysis of Variance (ANOVA) for treatment groups (Topiramate standard, Topiramate slow, Topiramate slow and Propranolol booster) was used.||||||0.9872
72615993|NCT01060111|144762456|SUPERIORITY_OR_OTHER|||||||0.4326||||||Analysis of Variance (ANOVA) for treatment groups (Topiramate standard, Topiramate slow, Topiramate slow and Propranolol booster) was used.|ANOVA|||||||0.4326
72615994|NCT01004393|144762464|SUPERIORITY_OR_OTHER|||||||0.161|TWO_SIDED||||||ANOVA|||||||0.161
72615995|NCT04999020|144762466|SUPERIORITY||Difference in response rates|-15.38||||0.4192|TWO_SIDED|80.0|-38.55|8.48|||Barnard's unconditional exact test|||||8.48|-38.55|0.4192
72615996|NCT02448043|144762482|SUPERIORITY|||||||0.532||||||Threshold is p\<0.05|t-test, 2 sided|||||||0.532
72615997|NCT02448043|144762483|SUPERIORITY|||||||0.523||||||Threshold is p\<0.05|t-test, 2 sided|||||||0.523
72615998|NCT02448043|144762484|SUPERIORITY|||||||0.912||||||Threshold is p\<0.05|t-test, 2 sided|||Comparing baseline values of both arms to completion values of both arms||||0.912
72615999|NCT02448043|144762485|SUPERIORITY|||||||0.062||||||Threshold is p\<0.05|t-test, 2 sided|||Comparison between baseline nail brittleness values and completion values||||0.062
72616000|NCT00997126|144762507|SUPERIORITY_OR_OTHER|||||||0.657|||||||Chi-squared|||||||0.657
72616001|NCT01835756|144762527|SUPERIORITY_OR_OTHER||||||<|1e-05|TWO_SIDED||||||t-test, 2 sided|||||||<0.00001
72616002|NCT01835756|144762528|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||t-test, 2 sided|||||||<0.0001
72616003|NCT02965456|144762532|SUPERIORITY||||||<|0.001||||||Threshold for significance at 0.05.|ANCOVA|||Analysis was performed using analysis of covariance (ANCOVA) with factors of treatment group and analysis center and the respective baseline lesion count as a covariate.||||<0.001
72432103|NCT02408965|144376647|SUPERIORITY|||||||0.06|||||||Chi-squared|||||||0.06
72432104|NCT02408965|144376648|SUPERIORITY|||||||0.07|||||||Chi-squared|||||||0.07
72432105|NCT02408965|144376649|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
72432106|NCT02408965|144376650|SUPERIORITY|||||||0.03|||||||Chi-squared|||||||0.03
72432107|NCT02408965|144376651|SUPERIORITY|||||||0.02|||||||Chi-squared|||||||0.02
72432108|NCT01352507|144376652|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilson Score method|||Null hypothesis (H0): The proportion of participants who chose tadalafil over sildenafil is equal to 0.5 (p = 0.5), versus alternative hypothesis (H1): p is not equal to 0.5 (2-sided test).||||<0.001
72432109|NCT01352507|144376654|SUPERIORITY_OR_OTHER||Least Squares (LS) mean difference|0.02||||0.793|TWO_SIDED|95.0|-0.11|0.15||P-Value and LS mean difference were from a crossover mixed effect model that included treatment, period, sequence, and site as fixed effects, baseline value of efficacy measure as covariate, and participant within sequence as random effect.|Mixed Models Analysis|||||0.15|-0.11|0.793
72554917|NCT04278560|144641735|SUPERIORITY||Mean Difference (Net)|9.94||||0.17|TWO_SIDED||||||ANOVA|We used change from baseline for this analysis. Two-Way Repeated Measure ANOVA: Group, Time, Group x Time, and controlled baseline.||||||0.17
72554918|NCT04278560|144641736|SUPERIORITY||Median Difference (Net)|0.6||||0.1|TWO_SIDED||||||ANOVA|We used change from baseline for this analysis. Two-Way Repeated Measure ANOVA: Group, Time, Group x Time, and controlled baseline.||||||0.1
72432110|NCT01352507|144376655|SUPERIORITY_OR_OTHER||LS mean difference|0.01||||0.988|TWO_SIDED|95.0|-1.35|1.37||P-Value and LS mean difference were from a crossover mixed effect model that included treatment, period, sequence, and site as fixed effects, baseline value of efficacy measure as covariate, and participant within sequence as random effect.|Mixed Models Analysis|||||1.37|-1.35|0.988
72395047|NCT02700815|144296595|SUPERIORITY||Mean Difference (Net)|-1.12|STANDARD_ERROR_OF_MEAN|0.223|<|0.0001|TWO_SIDED|95.0|-1.56|-0.68|||Mixed Models Analysis||The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|A Mixed Model Repeat Measures (MMRM) analysis was used to compare change in POMwp from baseline between diclofenac and combination therapy diclofenac + capsaicin. MMRM model included fixed effects of treatment, country, application site (back/neck), time and fixed covariates of baseline POMwp and baseline POMwp by time interaction.||-0.68|-1.56|<0.0001
72554919|NCT04278560|144641737|SUPERIORITY||Median Difference (Net)|0.07||||0.7|TWO_SIDED||||||ANOVA|We used change from baseline for this analysis. Two-Way Repeated Measure ANOVA: Group, Time, Group x Time, and controlled baseline||||||0.7
72554920|NCT04278560|144641738|SUPERIORITY|||||||0.46|||||||t-test, 2 sided|||||||0.46
72554921|NCT04278560|144641739|SUPERIORITY|||||||0.16|||||||t-test, 2 sided|||||||0.16
72432111|NCT01352507|144376656|SUPERIORITY_OR_OTHER||LS mean difference|0.03||||0.102|TWO_SIDED|95.0|-0.01|0.08||P-Value and LS mean difference were from a crossover mixed effect model that included treatment, period, sequence, and site as fixed effects, baseline value of efficacy measure as covariate, and participant within sequence as random effect.|Mixed Models Analysis|||||0.08|-0.01|0.102
72395048|NCT02700815|144296596|SUPERIORITY||Mean Difference (Net)|-0.13|STANDARD_ERROR_OF_MEAN|0.844||0.881|TWO_SIDED|95.0|-1.78|1.53|||Mixed Models Analysis||The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|A Mixed Model Repeat Measures (MMRM) analysis was used to compare change in PA from baseline between placebo and combination therapy diclofenac + capsaicin. MMRM model included fixed effects of treatment, country, application site (back/neck), time and fixed covariates of baseline PA and baseline PA by time interaction.||1.53|-1.78|0.8810
72616004|NCT02965456|144762533|SUPERIORITY||||||<|0.001||||||Threshold for significance at 0.05.|ANCOVA|||Analysis was performed using ANCOVA with factors of treatment group and analysis center and the respective baseline lesion count as a covariate.||||<0.001
72432112|NCT01352507|144376658|SUPERIORITY_OR_OTHER||LS mean difference|-0.01||||0.861|TWO_SIDED|95.0|-0.22|0.19||P-Value and LS mean difference were from a crossover mixed effect model that included treatment, period, sequence, and site as fixed effects, baseline value of efficacy measure as covariate, and participant within sequence as random effect.|Mixed Models Analysis|||||0.19|-0.22|0.861
72616005|NCT02965456|144762534|SUPERIORITY|||||||0.007||||||Threshold for significance at 0.05.|Regression, Logistic|||Analysis was performed using a logistic regression test (using Firth's Penalized Likelihood) with factors of treatment group and analysis center.||||0.007
72616006|NCT04465955|144762551|SUPERIORITY||Mean Difference (Final Values)|-0.15||||0.4345|TWO_SIDED|95.0|-0.528|0.227|||Random coefficient model|Covariates included terms for time, treatment-by-time interaction, baseline fellow eye CNV status, baseline focality, and baseline GA lesion location||Rate of Change Difference Between NGM621 Q4W and Pooled Sham||0.227|-0.528|0.4345
72432113|NCT01352507|144376659|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.05||||0.495|TWO_SIDED|95.0|-0.19|0.09||P-Value and LS mean difference were from a crossover mixed effect model that included treatment, period, sequence, and site as fixed effects, baseline value of efficacy measure as covariate, and participant within sequence as random effect.|Mixed Models Analysis|||||0.09|-0.19|0.495
72432114|NCT01352507|144376660|SUPERIORITY_OR_OTHER||LS mean difference|-0.01||||0.917|TWO_SIDED|95.0|-0.18|0.16||P-Value and LS mean difference were from a crossover mixed effect model that included treatment, period, sequence, and site as fixed effects, baseline value of efficacy measure as covariate, and participant within sequence as random effect.|Mixed Models Analysis|||||0.16|-0.18|0.917
72554922|NCT02832063|144641742|EQUIVALENCE|Primary efficacy power calculations assume a \>25% difference between B244 treatment and placebo and a 15% dropout. Each of the endpoints comprising the co-primary endpoint will be tested at an alpha level of p\<0.05. In order to achieve 90% power with a 5% Type I error rate, a total of 372 participants is required.||||||0.034|||||||ANCOVA|||||||0.034
72371333|NCT00122980|144252905|NON_INFERIORITY_OR_EQUIVALENCE|"Based on pilot data, the efficacy of hydroxyurea to reduce secondary stroke rate was not predicted to be equivalent to transfusions. Therefore, an increased stroke rate (non-inferiority margin = 0.20) was allowed by study design. This acceptable stroke margin was predicted to be offset by the likelihood of significantly greater improvement in the management of iron overload through elimination of transfusions along with serial phlebotomy in the Hydroxyurea/Phlebotomy arm."||||||0.214||95.0|||||Log Rank|||Concluding that Hydroxyurea/Phlebotomy group is better than the Transfusion/Chelation group required rejecting the STROKE null hypothesis in favor of the alternative: Hydroxyurea/Phlebotomy recurrent stroke rate is less than Transfusion/Chelation rate plus 0.20, the non-inferiority margin, AND rejecting the IRON null hypothesis in favor of the alternative: Hydroxyurea/Phlebotomy baseline-adjusted mean LIC is less than for Transfusion/Chelation (see next primary endpoint analysis).||||0.214
72432115|NCT01352507|144376661|SUPERIORITY_OR_OTHER||LS mean difference|1.23||||0.391|TWO_SIDED|95.0|-1.58|4.04||P-Value and LS mean difference were from a crossover mixed effect model that included treatment, period, sequence, and site as fixed effects, baseline value of efficacy measure as covariate, and participant within sequence as random effect.|Mixed Models Analysis|||||4.04|-1.58|0.391
72432116|NCT01352507|144376662|SUPERIORITY_OR_OTHER||LS mean difference|0.13|||<|0.001|TWO_SIDED|95.0|0.09|0.18||P-Value and LS mean difference were from a crossover mixed effect model that included treatment, period, sequence, and site as fixed effects, baseline value of efficacy measure as covariate, and participant within sequence as random effect.|Mixed Models Analysis|||||0.18|0.09|<0.001
72432117|NCT01352507|144376663|SUPERIORITY_OR_OTHER||LS mean difference|-0.14|||<|0.001|TWO_SIDED|95.0|-0.19|-0.09||P-Value and LS mean difference were from a crossover mixed effect model that included treatment, period, sequence, and site as fixed effects, baseline value of efficacy measure as covariate, and participant within sequence as random effect.|Mixed Models Analysis|||||-0.09|-0.19|<0.001
72432118|NCT01352507|144376664|SUPERIORITY_OR_OTHER||LS mean difference|0.18||||0.364|TWO_SIDED|95.0|-0.2|0.55||P-Value and LS mean difference were from a crossover mixed effect model that included treatment, period, sequence, and site as fixed effects, baseline value of efficacy measure as covariate, and participant within sequence as random effect.|Mixed Models Analysis|||||0.55|-0.20|0.364
72432119|NCT00916006|144376692|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||Cochran-Mantel-Haenszel|||||||0.001
72432120|NCT00916006|144376693|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||Cochran-Mantel-Haenszel|||||||0.001
72432121|NCT04824131|144376727|OTHER||Exact CI for Proportions|0.0|||||TWO_SIDED|95.0|0.0|6.7|||||||Exact 95% Confidence Interval for Proportion for Participants who Discontinued Early due to Intolerability of Injection or Burden of Study Procedures|6.7|0|
72432122|NCT04824131|144376728|OTHER||Exact CI for Proportions|61.5|||||TWO_SIDED|95.0|47.0|74.7|||||||Exact 95% confidence interval for proportion for Participants who received at least one injection and preferred injectable PrEP at end of step 2.|74.7|47.0|
72432123|NCT04824131|144376731|OTHER||Exact CI for Proportions|94.3|||||TWO_SIDED|95.0|84.3|98.8|||||||The Exact 95% Confidence Interval for Proportion for Number of Participants with Grade 2 or above AEs during Injection Phase|98.8|84.3|
72432124|NCT04824131|144376732|OTHER||Exact CI for Proportions|100.0|||||TWO_SIDED|95.0|93.3|100.0|||||||Exact 95% Confidence Interval for Proportion for Participants who received at least one Injection who Completed All Scheduled Injections|100|93.3|
72432125|NCT04824131|144376733|OTHER||Mean Difference (Final Values)|-0.2728|STANDARD_ERROR_OF_MEAN|0.1704||0.1093|TWO_SIDED|95.0|-0.61|0.06||"GEE for Change in Sexual Behavior - Number of Sexual Partners - Visit as Continuous Variable.~Difference from baselines in the number of sex partners (vaginal or anal sex) reported in the past month"|poisson model||"GEE for Change in Sexual Behavior - Number of Sexual Partners - Visit as Continuous Variable.~Difference from baselines in the number of sex partners (vaginal or anal sex) reported in the past month"|Generalized estimating equations (GEE) with robust variance to model change in self-reported sexual behavior from enrollment (W0) to follow up visits (W4, W5, W9, W17, W25, W33, W+12, W+24, W+36, W+48), with an indicator variable for all on-study visits (i.e. enrollment visit = 0) to measure change in the outcome behavior. We will model count outcomes (number of sexual partners) using a poisson model.||0.06|-0.61|0.1093
72432126|NCT04824131|144376734|OTHER||Mean Difference (Final Values)|-0.5859|STANDARD_ERROR_OF_MEAN|0.2253||0.0093|TWO_SIDED|95.0|-1.03|-0.14||GEE for Change in Sexual Behavior - Number of Episodes of Vaginal Sex without a Condom - Visit as Continuous Variable. Difference from baselines in the number of vaginal sex without a condom reported in the past month|poisson model||GEE for Change in Sexual Behavior - Number of Episodes of Vaginal Sex without a Condom - Visit as Continuous Variable. Difference from baselines in the number of vaginal sex without a condom reported in the past month.|Generalized estimating equations (GEE) with robust variance to model change in self-reported sexual behavior from enrollment (W0) to follow up visits (W4, W5, W9, W17, W25, W33, W+12, W+24, W+36, W+48), with an indicator variable for all on-study visits (i.e. enrollment visit = 0) to measure change in the outcome behavior. We will model count outcomes (number of episodes of vaginal sex without a condom) using a poisson model.||-0.14|-1.03|0.0093
72371334|NCT00122980|144252906|SUPERIORITY_OR_OTHER|||||||0.144||95.0||||The a priori defined LOCF approach was deemed to be biased due to the study's early termination, and was replaced by this mixed models analysis.|Mixed Models Analysis|Including main effects of age at consent, baseline iron, and treatment group, on observed change from baseline Log10 transformed values only.||Concluding that Hydroxyurea/Phlebotomy group is better than the Transfusion/Chelation group required rejecting the STROKE null hypothesis (see previous primary endpoint analysis) in favor of the alternative: Hydroxyurea/Phlebotomy recurrent stroke rate is less than Transfusion/Chelation rate plus 0.20 AND rejecting the IRON null hypothesis in favor of the alternative: Hydroxyurea/Phlebotomy baseline-adjusted mean log10 transformed LIC is less than for Transfusion/Chelation.||||0.144
72371335|NCT00122980|144252907|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||ANOVA|The change-from-baseline scores for each scale were analyzed with an analysis of variance model (ANOVA) with treatment as stratum.||The change-from-baseline scores were analyzed with an analysis of variance model (ANOVA) with treatment as stratum, testing the hypothesis that the average change from baseline scores do not differ between the treatment groups.||||>0.05
72371336|NCT00122980|144252908|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||ANOVA|The change-from-baseline scores for each scale were analyzed with an analysis of variance model (ANOVA) with treatment as stratum.||The change-from-baseline scores were analyzed with an analysis of variance model (ANOVA) with treatment as stratum.||||>0.05
72371337|NCT00122980|144252909|SUPERIORITY_OR_OTHER|||||||0.841||95.0|||||ANOVA|||The change-from-baseline to endpoint scores were analyzed with an analysis of variance model (ANOVA) with treatment as stratum.||||0.841
72371338|NCT00122980|144252910|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||ANOVA|||The change-from-baseline scores were analyzed with an analysis of variance model (ANOVA) with treatment as stratum, testing the hypothesis that the average change from baseline scores do not differ between the treatment groups.||||>0.05
72371339|NCT00122980|144252911|SUPERIORITY_OR_OTHER|||||||0.039||95.0|||||ANOVA|||The change-from-baseline scores were analyzed with an analysis of variance model (ANOVA) with treatment as stratum, testing the hypothesis that the average change from baseline scores do not differ between the treatment groups.||||0.039
72371340|NCT00122980|144252912|SUPERIORITY_OR_OTHER|||||||0.033||95.0|||||ANCOVA|Analysis controlling for baseline value and time on study.||||||0.033
72371341|NCT00122980|144252913|SUPERIORITY_OR_OTHER||||||<|0.01||95.0|||||ANCOVA|Controlling for baseline value and time on study||||||<0.01
72371342|NCT01243242|144252920|SUPERIORITY_OR_OTHER|||||||0.0093||95.0||||p value for the difference between groups in change from Screening to Termination was calculated using the median test for independent samples|Median|||For the primary endpoint (CAARS change), median test was applied as the primary analysis due to outlier numbers observed ; secondary analysis of the primary endpoint utilized ANCOVA with adjustment to age, gender and site (which is usually expected to influence the endpoint) as well as baseline values. Additional parametric T-test was applied, but was found less effective due to outlier values.||||0.0093
72371343|NCT01243242|144252921|SUPERIORITY_OR_OTHER|||||||0.0195||95.0||||p value for the difference between groups in change from Screening to Termination was calculated using ANCOVA, adjusted for baseline score, gender, site and age|ANCOVA|||Analysis of Covariance (ANCOVA) was applied for comparing the differences in changes from screening/baseline (Visit 1) to termination (Visit 6) and to Visits 3 through 5 in the primary endpoint, CAARS, and secondary endpoint scales, CGI-S, TOVA and AAQoL between the study groups with adjustment to confounders (baseline score, site, age, gender, dose and past exposure to any other ADHD drug).||||0.0195
72371344|NCT01243242|144252922|SUPERIORITY_OR_OTHER|||||||0.0093||95.0||||p value for the difference between groups in change from Screening to Termination was calculated using ANCOVA, adjusted for baseline score, gender, site and age.|ANCOVA|||Analysis of covariance (ANCOVA) was applied for comparing the differences in changes from screening/baseline (Visit 1) to termination (Visit 6) between the study groups with adjustment to confounders (baseline score, site, age, gender, dose and past exposure to any other ADHD drug).||||0.0093
72371345|NCT01256294|144252953|SUPERIORITY_OR_OTHER||Ratio of geometric means|1.02|||||TWO_SIDED|95.0|0.96|1.09||||||||1.09|0.96|
72371346|NCT01256294|144252953|SUPERIORITY_OR_OTHER||Ratio of geometric means|1.02||||0.486|TWO_SIDED|90.0|0.97|1.08||ANOVA model for the dose-normalized log transformed values with treatment, period and sequence as fixed factors and subjects nested within sequences as a random factor.|ANOVA|||To compare the bioavailability of generic tacrolimus to branded tacrolimus, the 90% confidence intervals of the ratios of geometric means of AUC0-12h were assessed relative to the interval \[80%, 125%\].||1.08|0.97|0.486
72371347|NCT01256294|144252958|SUPERIORITY_OR_OTHER||Ratio of geometric means|1.09|||||TWO_SIDED|95.0|1.0|1.2|||||Ratio of geometric means: Generic tacrolimus/Branded tacrolimus|||1.20|1.00|
72371348|NCT01256294|144252958|SUPERIORITY_OR_OTHER||Ratio of geometric means|1.09||||0.057|TWO_SIDED|90.0|1.01|1.18||ANOVA model for the dose-normalized log transformed values with treatment, period and sequence as fixed factors and subjects nested within sequences as a random factor.|ANOVA|||To compare the bioavailability of generic tacrolimus to branded tacrolimus, the 90% confidence intervals of the ratios of geometric means of Cmax were assessed relative to the interval \[80%, 125%\].||1.18|1.01|0.057
72371349|NCT02160899|144252959|SUPERIORITY||||||<|0.001|||||||ANOVA|||||||<.001
72371350|NCT02160899|144252959|SUPERIORITY||||||<|0.001|||||||ANOVA|||||||<.001
72371351|NCT02160899|144252959|SUPERIORITY|||||||0.044|||||||Exact Wilcoxon Rank Sum Test|||||||0.044
72371352|NCT00724711|144252964|NON_INFERIORITY_OR_EQUIVALENCE|"This study was designed to show noninferiority (change of \< 12%) in regard of proportions of responders (TLOVR) at Week 48.~With 170 subjects in each group, the lower limit of observed one-sided 97.5% confidence interval was expected to be greater than -0.120 with 80% power when the proportion of responders in both treatment groups is 0.820 (82%) at Week 48.~312 subjects were enrolled, representing 8% less than planned (n = 340). As a result, power to claim non-inferiority decreased to 78%."|Difference in percentages between groups|3.0|||||TWO_SIDED|95.0|-5.1|11.2|||Inverted two one-sided tests|Inverted two one-sided tests with the standardized statistic||"Null hypothesis: The TVD group is at least 12% worse than the ABC/3TC group with respect to the percentage of subjects maintaining HIV-1 RNA \< 200 copies/mL through Week 48 (responder rate, as defined by the TLOVR algorithm)~Alternative hypothesis: The TVD group is less than 12% worse than the ABC/3TC group with respect to the percentage of subjects maintaining HIV-1 RNA \< 200 copies/mL through Week 48 (responder rate, as defined by the TLOVR algorithm)"||11.2|-5.1|
72371353|NCT05111301|144253001|SUPERIORITY|||||||0.004|||||||t-test, 2 sided|||For Control-IQ Versus Baseline||||0.004
72371354|NCT05111301|144253002|SUPERIORITY|||||||0.004|||||||t-test, 2 sided|||For Control-IQ Versus Baseline||||0.004
72371355|NCT05111301|144253003|SUPERIORITY|||||||0.54|||||||t-test, 2 sided|||For Control-IQ Versus Baseline||||0.54
72371356|NCT05111301|144253004|SUPERIORITY|||||||0.03|||||||t-test, 2 sided|||For Control-IQ Versus Baseline||||0.03
72371357|NCT05111301|144253005|SUPERIORITY|||||||0.001|||||||t-test, 2 sided|||For Control-IQ Versus Baseline||||0.001
72371358|NCT05111301|144253006|SUPERIORITY|||||||0.01|||||||t-test, 2 sided|||For Control-IQ Versus Baseline||||0.01
72371359|NCT05111301|144253007|SUPERIORITY|||||||0.8|||||||t-test, 2 sided|||For Control-IQ Versus Baseline||||0.80
72371360|NCT04838977|144253058|SUPERIORITY||Between group difference|-4.2|||||TWO_SIDED|95.0|-7.6|-0.8||||||The null hypothesis is there is no difference in mean CPSS at 10 weeks in the intervention group versus the control group.||-0.8|-7.6|
72371361|NCT02891070|144253084|NON_INFERIORITY|To demonstrate non-inferiority (NI) of Tisseel to DuraSeal for the primary endpoint, the lower limit of the 95% CI (based on normal approximation) for the difference in average predicted proportions had to be greater than -10%.|Mean Difference (Net)|-9.29|||||TWO_SIDED|95.0|-21.11|2.54|||Regression, Logistic||Difference in Average Predicted Proportion (Tisseel - Duraseal)|||2.54|-21.11|
72371362|NCT02891070|144253086|OTHER||Mean Difference (Net)|-9.29|||||TWO_SIDED|95.0|-21.11|2.54|||Regression, Logistic||Difference in Average Predicted Proportion (Tisseel - Duraseal)|||2.54|-21.11|
72371363|NCT02891070|144253087|OTHER|||||||0.0241|||||||Wilcoxon (Mann-Whitney)|||||||0.0241
72371364|NCT02891070|144253088|OTHER|||||||0.1015|||||||Wilcoxon (Mann-Whitney)|||||||0.1015
72371365|NCT02891070|144253089|OTHER|||||||0.9943|||||||Wilcoxon (Mann-Whitney)|||||||0.9943
72371366|NCT02891070|144253090|OTHER||Mean Difference (Net)|-5.11|||||TWO_SIDED|95.0|-13.6|3.39|||Regression, Logistic|||||3.39|-13.60|
72371367|NCT04335136|144253142|OTHER|||||||0.5207||||||The level of significance was 5% (2-sided).|Chi-squared|||"Hypothesis tested: H0: pAPN01 = pPlacebo; H1: pAPN01 ≠ pPlacebo (with p=proportion of patients with event).~A total of 186 patients (93 per group) was estimated to yield 80% power to detect a 20% absolute risk reduction in the primary, from 50% in the placebo group to 30% in the APN01 group, at a 2-sided alpha of 0.05. To consider patients who would be randomized but not treated, a total of 200 patients (100 per group) were planned to be enrolled."||||0.5207
72371368|NCT04335136|144253142|OTHER||Odds Ratio (OR)|0.63||||0.3588|TWO_SIDED|95.0|0.23|1.7|||Regression, Logistic|Degree of freedom: 1||||1.70|0.23|0.3588
72432127|NCT04824131|144376734|OTHER||Mean Difference (Final Values)|-0.3087|STANDARD_ERROR_OF_MEAN|1.4036||0.8259|TWO_SIDED|95.0|-3.06|2.44||GEE for Change in Sexual Behavior - Number of Episodes of Anal Sex without a Condom - Visit as Continuous Variable. Difference from baselines in the number of anal sex without a condom reported in the past month|Regression, Logistic||GEE for Change in Sexual Behavior - Number of Episodes of Anal Sex without a Condom - Visit as Continuous Variable. Difference from baselines in the number of anal sex without a condom reported in the past month|Generalized estimating equations (GEE) with robust variance to model change in self-reported sexual behavior from enrollment (W0) to follow up visits (W4, W5, W9, W17, W25, W33, W+12, W+24, W+36, W+48), with an indicator variable for all on-study visits (i.e. enrollment visit = 0) to measure change in the outcome behavior. We will model binary outcomes (any episodes of anal sex without a condom) using a logistic model.||2.44|-3.06|0.8259
72371369|NCT03120351|144253168|SUPERIORITY||Mean Difference (Net)|-2.5||||0.28|TWO_SIDED|95.0|-7.11|2.06|||Mixed Models Analysis|||||2.06|-7.11|0.28
72371370|NCT01256190|144253169|SUPERIORITY_OR_OTHER|||||||0.004||95.0|||||t-test, 2 sided|||||||0.004
72371371|NCT01256190|144253170|SUPERIORITY_OR_OTHER|||||||0.31||95.0|||||t-test, 2 sided|||||||0.31
72371372|NCT01256190|144253171|SUPERIORITY_OR_OTHER|||||||0.022||95.0|||||Fisher Exact|||intent-to-treat analysis||||.022
72371373|NCT01256190|144253172|SUPERIORITY_OR_OTHER|||||||0.113||95.0|||||Fisher Exact|||intent-to treat analysis||||0.113
72371374|NCT01256190|144253173|SUPERIORITY_OR_OTHER|||||||0.025||95.0|||||Fisher Exact|||intent-to-treat analysis||||.025
72371375|NCT04693234|144253184|SUPERIORITY|||||||0.0054|||||||Binomial Exact Test|The p-value was calculated from the binomial exact test of tislelizumab combined with ociperlimab versus historical rate of 0.15.||||||0.0054
72371376|NCT04693234|144253185|SUPERIORITY|||||||0.0127|||||||Binomial Exact Test|The p-value was calculated from the binomial exact test of tislelizumab combined with ociperlimab versus historical rate of 0.15.||||||0.0127
72371377|NCT04643158|144253205|SUPERIORITY||Least Square Mean Difference|0.0236||||0.828|TWO_SIDED|95.0|-0.1934|0.2406|||Mixed Models Analysis|||||0.2406|-0.1934|0.828
72371378|NCT04643158|144253205|SUPERIORITY||Least Square Mean Difference|0.196||||0.035|TWO_SIDED|95.0|0.0143|0.3778|||Mixed Models Analysis|||||0.3778|0.0143|0.035
72371379|NCT04643158|144253225|SUPERIORITY||Geometric Least Square Mean Ratio|-38.31||||0.202|TWO_SIDED|95.0|-71.11|31.72|||Mixed Models Analysis||Analyses were done on the natural log scale and the results were back-transformed to linear scale.|||31.72|-71.11|0.202
72371380|NCT04643158|144253225|SUPERIORITY||Geometric Least Square Mean Ratio|-15.43||||0.596|TWO_SIDED|95.0|-55.57|60.96|||Mixed Models Analysis||Analyses were done on the natural log scale and the results were back-transformed to linear scale.|||60.96|-55.57|0.596
72371381|NCT02197078|144253236|OTHER||Hazard Ratio (HR)|0.82|||||TWO_SIDED|95.0|0.66|1.03||||||||1.03|0.66|
72371382|NCT02197078|144253236|OTHER||Hazard Ratio (HR)|0.85|||||TWO_SIDED|95.0|0.65|1.1||||||||1.10|0.65|
72371383|NCT02197078|144253236|OTHER||Hazard Ratio (HR)|0.65|||||TWO_SIDED|95.0|0.49|0.86||||||||0.86|0.49|
72371384|NCT02197078|144253236|OTHER||Hazard Ratio (HR)|0.95|||||TWO_SIDED|95.0|0.83|1.1||||||||1.10|0.83|
72371385|NCT02197078|144253236|OTHER||Hazard Ratio (HR)|1.01|||||TWO_SIDED|95.0|0.85|1.19||||||||1.19|0.85|
72371386|NCT02197078|144253236|OTHER||Hazard Ratio (HR)|0.8|||||TWO_SIDED|95.0|0.66|0.96||||||||0.96|0.66|
72371387|NCT02197078|144253237|OTHER||Hazard Ratio (HR)|0.9|||||TWO_SIDED|95.0|0.66|1.23||||||||1.23|0.66|
72371388|NCT02197078|144253237|OTHER||Hazard Ratio (HR)|0.81|||||TWO_SIDED|95.0|0.57|1.16||||||||1.16|0.57|
72371389|NCT02197078|144253237|OTHER||Hazard Ratio (HR)|0.7|||||TWO_SIDED|95.0|0.48|1.01||||||||1.01|0.48|
72371390|NCT02197078|144253237|OTHER||Hazard Ratio (HR)|1.04|||||TWO_SIDED|95.0|0.85|1.28||||||||1.28|0.85|
72371391|NCT02197078|144253237|OTHER||Hazard Ratio (HR)|1.01|||||TWO_SIDED|95.0|0.79|1.28||||||||1.28|0.79|
72371392|NCT02197078|144253237|OTHER||Hazard Ratio (HR)|0.81|||||TWO_SIDED|95.0|0.62|1.06||||||||1.06|0.62|
72371393|NCT02197078|144253238|OTHER||Hazard Ratio (HR)|0.69|||||TWO_SIDED|95.0|0.51|0.94||||||||0.94|0.51|
72371394|NCT02197078|144253238|OTHER||Hazard Ratio (HR)|0.63|||||TWO_SIDED|95.0|0.44|0.9||||||||0.90|0.44|
72371395|NCT02197078|144253238|OTHER||Hazard Ratio (HR)|0.6|||||TWO_SIDED|95.0|0.41|0.88||||||||0.88|0.41|
72371396|NCT02197078|144253238|OTHER||Hazard Ratio (HR)|0.97|||||TWO_SIDED|95.0|0.81|1.17||||||||1.17|0.81|
72371397|NCT02197078|144253238|OTHER||Hazard Ratio (HR)|0.96|||||TWO_SIDED|95.0|0.77|1.19||||||||1.19|0.77|
72371398|NCT02197078|144253238|OTHER||Hazard Ratio (HR)|0.76|||||TWO_SIDED|95.0|0.6|0.97||||||||0.97|0.60|
72371399|NCT02197078|144253239|OTHER||Hazard Ratio (HR)|0.89|||||TWO_SIDED|95.0|0.58|1.38||||||||1.38|0.58|
72371400|NCT02197078|144253239|OTHER||Hazard Ratio (HR)|0.99|||||TWO_SIDED|95.0|0.6|1.64||||||||1.64|0.60|
72371401|NCT02197078|144253239|OTHER||Hazard Ratio (HR)|0.44|||||TWO_SIDED|95.0|0.24|0.78||||||||0.78|0.24|
72371402|NCT02197078|144253239|OTHER||Hazard Ratio (HR)|0.96|||||TWO_SIDED|95.0|0.73|1.25||||||||1.25|0.73|
72371403|NCT02197078|144253239|OTHER||Hazard Ratio (HR)|1.09|||||TWO_SIDED|95.0|0.78|1.52||||||||1.52|0.78|
72371404|NCT02197078|144253239|OTHER||Hazard Ratio (HR)|0.74|||||TWO_SIDED|95.0|0.52|1.05||||||||1.05|0.52|
72371405|NCT02197078|144253240|OTHER||Hazard Ratio (HR)|1.55|||||TWO_SIDED|95.0|1.1|2.18||||||||2.18|1.10|
72371406|NCT02197078|144253240|OTHER||Hazard Ratio (HR)|1.9|||||TWO_SIDED|95.0|1.19|3.03||||||||3.03|1.19|
72371407|NCT02197078|144253240|OTHER||Hazard Ratio (HR)|1.11|||||TWO_SIDED|95.0|0.73|1.68||||||||1.68|0.73|
72371408|NCT02197078|144253240|OTHER||Hazard Ratio (HR)|0.99|||||TWO_SIDED|95.0|0.76|1.29||||||||1.29|0.76|
72371409|NCT02197078|144253240|OTHER||Hazard Ratio (HR)|1.1|||||TWO_SIDED|95.0|0.77|1.56||||||||1.56|0.77|
72371410|NCT02197078|144253240|OTHER||Hazard Ratio (HR)|0.79|||||TWO_SIDED|95.0|0.54|1.14||||||||1.14|0.54|
72371411|NCT02197078|144253241|OTHER||Hazard Ratio (HR)|1.4|||||TWO_SIDED|95.0|0.97|2.0||||||||2.00|0.97|
72371412|NCT02197078|144253241|OTHER||Hazard Ratio (HR)|1.71|||||TWO_SIDED|95.0|1.07|2.72||||||||2.72|1.07|
72371413|NCT02197078|144253241|OTHER||Hazard Ratio (HR)|1.16|||||TWO_SIDED|95.0|0.75|1.79||||||||1.79|0.75|
72371414|NCT02197078|144253241|OTHER||Hazard Ratio (HR)|1.34|||||TWO_SIDED|95.0|1.01|1.76||||||||1.76|1.01|
72371415|NCT02197078|144253241|OTHER||Hazard Ratio (HR)|1.52|||||TWO_SIDED|95.0|1.02|2.27||||||||2.27|1.02|
72371416|NCT02197078|144253241|OTHER||Hazard Ratio (HR)|1.17|||||TWO_SIDED|95.0|0.81|1.71||||||||1.71|0.81|
72371417|NCT02197078|144253242|OTHER||Hazard Ratio (HR)|1.24|||||TWO_SIDED|95.0|1.04|1.47||||||||1.47|1.04|
72371418|NCT02197078|144253242|OTHER||Hazard Ratio (HR)|1.31|||||TWO_SIDED|95.0|1.06|1.61||||||||1.61|1.06|
72371419|NCT02197078|144253242|OTHER||Hazard Ratio (HR)|1.04|||||TWO_SIDED|95.0|0.84|1.29||||||||1.29|0.84|
72371420|NCT02197078|144253242|OTHER||Hazard Ratio (HR)|1.04|||||TWO_SIDED|95.0|0.91|1.19||||||||1.19|0.91|
72371421|NCT02197078|144253242|OTHER||Hazard Ratio (HR)|1.07|||||TWO_SIDED|95.0|0.9|1.27||||||||1.27|0.90|
72371422|NCT02197078|144253242|OTHER||Hazard Ratio (HR)|0.91|||||TWO_SIDED|95.0|0.75|1.09||||||||1.09|0.75|
72371423|NCT02197078|144253243|OTHER||Hazard Ratio (HR)|1.62|||||TWO_SIDED|95.0|0.64|4.06||||||||4.06|0.64|
72371424|NCT02197078|144253243|OTHER||Hazard Ratio (HR)|1.67|||||TWO_SIDED|95.0|0.61|4.58||||||||4.58|0.61|
72371425|NCT02197078|144253243|OTHER||Hazard Ratio (HR)|1.84|||||TWO_SIDED|95.0|0.62|5.48||||||||5.48|0.62|
72371426|NCT02197078|144253243|OTHER||Hazard Ratio (HR)|1.17|||||TWO_SIDED|95.0|0.57|2.4||||||||2.40|0.57|
72371427|NCT02197078|144253243|OTHER||Hazard Ratio (HR)|0.96|||||TWO_SIDED|95.0|0.38|2.43||||||||2.43|0.38|
72371428|NCT02197078|144253243|OTHER||Hazard Ratio (HR)|1.65|||||TWO_SIDED|95.0|0.64|4.27||||||||4.27|0.64|
72371429|NCT03679754|144253262|OTHER||||||||||||||||||Subjects in the Expansion trial did not have biopsies analyzed for cellular responses.|||
72371430|NCT05487196|144253272|NON_INFERIORITY|The noninferiority margin δ was set as the median of fentanyl group + 30 representing a 1-point pain numeric rating scale difference per unit time across the 30-minute initiation period. A conventional 1-sided 95% confidence interval (CI) was constructed using normal distribution assumptions. Analysis was by intent to treat. Comparisons of PI-AUC30 between the three agents were made by one-way ANOVA.||||||0.226|||||||ANOVA|||||||0.226
72371431|NCT05487196|144253273|SUPERIORITY|||||||0.16|||||||ANOVA|||||||0.16
72371432|NCT05487196|144253274|SUPERIORITY|||||||0.03|||||||ANOVA|||||||0.03
72371433|NCT05487196|144253275|SUPERIORITY|||||||0.07|||||||ANOVA|||||||0.07
72371434|NCT05487196|144253276|SUPERIORITY|||||||0.22|||||||ANOVA|||||||0.22
72371435|NCT05487196|144253277|SUPERIORITY|||||||0.28|||||||Fisher Exact|||||||0.28
72371436|NCT05487196|144253278|SUPERIORITY|||||||0.83|||||||Fisher Exact|||||||0.83
72371437|NCT05487196|144253279|SUPERIORITY|||||||0.01|||||||Fisher Exact|||||||0.01
72371438|NCT05487196|144253280|SUPERIORITY|||||||0.36|||||||Fisher Exact|||||||0.36
72371439|NCT05487196|144253281|SUPERIORITY|||||||0.36|||||||Fisher Exact|||||||0.36
72371440|NCT05487196|144253282|SUPERIORITY|||||||0.54|||||||Fisher Exact|||||||0.54
72371441|NCT05487196|144253283|SUPERIORITY|||||||0.58|||||||Kruskal-Wallis|||||||0.58
72371442|NCT05487196|144253284|SUPERIORITY|||||||0.98|||||||Kruskal-Wallis|||||||0.98
72371443|NCT00884741|144253289|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.13||||0.11|TWO_SIDED|95.0|0.93|1.37||To control for type I error in testing the co-primary endpoints, the significance criterion for OS was 0.023 (one-sided) and for PFS was 0.002 (one-sided).|Log Rank|||The trial was designed to concurrently provide 80% power for the detection of a 25% relative reduction in mortality hazard (hazard ratio .75) and 30% reduction in progression hazard (hazard ratio .70) for the addition of bevacizumab to temozolomide and radiation. To control for type I error in testing the co-primary endpoints, the significance criterion for OS was 0.023 (one-sided) and for PFS was 0.002 (one-sided).||1.37|0.93|0.11
72432128|NCT04824131|144376735|OTHER||CI for Incidence rate, exact Poisson|0.0|||||TWO_SIDED|95.0|0.0|10.8|||||Person-years: 34.0||Incidence rate is calculated HIV infections per 100 person years. CI for Incidence rate is calculated using exact Poisson method|10.8|0.0|
72432129|NCT05489224|144376736|EQUIVALENCE|Predefined margin: -0.6 to 0.5|Treatment difference and 90% CI|-0.1|||||TWO_SIDED|90.0|-0.3|0.1|||ANCOVA|ANCOVA with multiple imputation||||0.10|-0.30|
72371444|NCT00884741|144253290|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.79||||0.004|TWO_SIDED|95.0|0.66|0.94||To control for type I error in testing the co-primary endpoints, the significance criterion for OS was 0.023 (one-sided) and for PFS was 0.002 (one-sided).|Log Rank|||The trial was designed to concurrently provide 80% power for the detection of a 25% relative reduction in mortality hazard (hazard ratio .75) and 30% reduction in progression hazard (hazard ratio .70) for the addition of bevacizumab to temozolomide and radiation. To control for type I error in testing the co-primary endpoints, the significance criterion for OS was 0.023 (one-sided) and for PFS was 0.002 (one-sided).||0.94|0.66|0.004
72371445|NCT00884741|144253291|SUPERIORITY_OR_OTHER|||||||0.42||||||Two-sided|Chi-squared|||||||0.42
72371446|NCT05661851|144253299|NON_INFERIORITY|Non-inferiority margin of -20 was used.|Least-square Mean Difference|5.9|STANDARD_ERROR_OF_MEAN|3.79|||TWO_SIDED|95.0|-1.67|13.38|||Linear Mixed Model|Kenward and Roger Method was used for the denominator degrees of freedom.|LS Mean difference was calculated as Test minus Control.|A sample size of 104 subjects provides at least 90% statistical power to test non-inferiority of the Test eyedrop compared to the Control eyedrop using a two sample t-test with a two-sided type I error rate of 0.05.||13.38|-1.67|
72371447|NCT05661851|144253300|NON_INFERIORITY|Non-inferiority margin of -20 was used.|Mean Population Difference Estimate|5.843|STANDARD_ERROR_OF_MEAN|4.456|||TWO_SIDED|95.0|-2.8904|14.5768|||Bootstrapping methods||Bootstrap Mean Difference was calculated as Test minus Control|A sample size of 104 subjects provides at least 90% statistical power to test non-inferiority of the Test eyedrop compared to the Control eyedrop using a two sample t-test with a two-sided type I error rate of 0.05.||14.5768|-2.8904|
72371448|NCT00612807|144253301|NON_INFERIORITY_OR_EQUIVALENCE|Testing whether slope of change over time varied by identified patient status and treatment condition.|Interaction term|-0.56|STANDARD_ERROR_OF_MEAN|0.29||0.056||95.0||||Interaction indicates that slope of change varied by identified patient status and tx condition. Slope of change in depression was significantly negative for everyone but identified patients in the control condition.|Fixed effect in multi-level model|||Utilized a hierarchical linear model with time nested within individual and individual nested within couple. Given the small sample size, we chose to include participants' baseline depression scores as a covariate, and model the trajectory of change in depression scores beginning with the second assessment, which occurred one month into the study. Additional fixed effect predictors included status as identified patient or spouse, treatment condition, time, and all possible interactions.||||0.056
72371449|NCT00612807|144253302|NON_INFERIORITY_OR_EQUIVALENCE|Testing whether slope of change over time varied by identified patient status and treatment condition.|Interaction term|0.64|STANDARD_ERROR_OF_MEAN|0.65||0.32||95.0|||||Fixed effect in multi-level model|||Utilized a hierarchical linear model with time nested within individual and individual nested within couple. Given the small sample size, we chose to include participants' baseline depression scores as a covariate, and model the trajectory of change in depression scores beginning with the second assessment, which occurred one month into the study. Additional fixed effect predictors included status as identified patient or spouse, treatment condition, time, and all possible interactions.||||0.32
72371450|NCT00612807|144253302|NON_INFERIORITY_OR_EQUIVALENCE|Testing whether means at each timepoint varied by identified patient status and treatment condition.|Interaction term|-12.97|STANDARD_ERROR_OF_MEAN|4.52||0.005||95.0||||We probed this interaction and discovered that at each assessment, spouses in the couple therapy + medication treatment group reported greater dyadic adjustment than did spouses in the medication alone condition (b = 10.53, z = 2.72, p = 0.006).|Fixed effect in multi-level model|||Utilized a hierarchical linear model with time nested within individual and individual nested within couple. Given the small sample size, we chose to include participants' baseline depression scores as a covariate, and model the trajectory of change in depression scores beginning with the second assessment, which occurred one month into the study. Additional fixed effect predictors included status as identified patient or spouse, treatment condition, time, and all possible interactions.||||0.005
72371451|NCT01215097|144253312|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.52|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001||95.0|-0.7|-0.34|||ANCOVA|||||-0.34|-0.70|<0.0001
72371452|NCT01215097|144253313|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.433|STANDARD_ERROR_OF_MEAN|0.062|<|0.0001|TWO_SIDED|95.0|-0.555|-0.311|||ANCOVA|||||-0.311|-0.555|<0.0001
72371453|NCT01215097|144253314|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.591|STANDARD_ERROR_OF_MEAN|0.082|<|0.0001||95.0|-0.752|-0.43|||ANCOVA|||||-0.43|-0.752|<0.0001
72371454|NCT01215097|144253315|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.53|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001||95.0|-0.7|-0.35|||ANCOVA|||||-0.35|-0.70|<0.0001
72371455|NCT01215097|144253316|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.52|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001||95.0|-0.71|-0.32|||ANCOVA|||||-0.32|-0.71|<0.0001
72371456|NCT01215097|144253317|SUPERIORITY_OR_OTHER||Adjusted mean difference|-9.6|STANDARD_ERROR_OF_MEAN|4.2||0.0233||95.0|-17.8|-1.3|||ANCOVA|||||-1.3|-17.8|0.0233
72371457|NCT01215097|144253318|SUPERIORITY_OR_OTHER||Adjusted mean difference|-22.1|STANDARD_ERROR_OF_MEAN|3.3|<|0.0001||95.0|-28.7|-15.6|||ANCOVA|||||-15.6|-28.7|<0.0001
72371458|NCT01215097|144253319|SUPERIORITY_OR_OTHER||Adjusted mean difference|-10.2|STANDARD_ERROR_OF_MEAN|3.6||0.005||95.0|-17.3|-3.1|||ANCOVA|||||-3.1|-17.3|0.0050
72371459|NCT01215097|144253320|SUPERIORITY_OR_OTHER||Adjusted mean difference|-11.5|STANDARD_ERROR_OF_MEAN|4.0||0.0044||95.0|-19.5|-3.6|||ANCOVA|||||-3.6|-19.5|0.0044
72432130|NCT04640571|144376763|EQUIVALENCE|Simple one-way t-test to assess if pravastatin AUC value is larger after metformin than after placebo.||||||0.02|||||||t-test, 1 sided|||||||0.02
72616007|NCT04465955|144762551|SUPERIORITY||Mean Difference (Final Values)|-0.155||||0.4217|TWO_SIDED|95.0|-0.536|0.225|||Random coefficient model|Covariates included terms for time, treatment-by-time interaction, baseline fellow eye CNV status, baseline focality, and baseline GA lesion location||Rate of Change Difference Between NGM621 Q8W and Pooled Sham||0.225|-0.536|0.4217
72432131|NCT04640571|144376764|EQUIVALENCE|Simple one-way t-test to assess if pravastatin Cmax value is larger after metformin than after placebo|||||<|0.05|||||||t-test, 1 sided|||||||<0.05
72432132|NCT04640571|144376765|EQUIVALENCE|Simple one-way t-test to assess if CDCA AUC value is reduced after metformin than after placebo.|||||<|0.05|||||||t-test, 1 sided|||||||<0.05
72622174|NCT02592655|144774354|SUPERIORITY_OR_OTHER|||||||0.5||||||Significance thresh hold: 0.05.|McNemar|||"Null hypothesis is that the 10 cm wide tourniquet tape is just as likely to occlude arterial flow as using two windlass tourniquets.~Participant count of 18 to accommodate for missing windlass tourniquet ultrasound data."||||0.5
72432133|NCT04640571|144376766|EQUIVALENCE|Simple one-way t-test to assess if CDCA Cmax value is reduced after metformin than after placebo.|||||<|0.05|||||||t-test, 1 sided|||||||<0.05
72432134|NCT04640571|144376767|EQUIVALENCE|Simple one-way t-test to assess if acyclovir AUC value is reduced after polysorbate 80 than after placebo|||||<|0.05|||||||t-test, 1 sided|||||||<0.05
72432135|NCT04640571|144376768|EQUIVALENCE|Simple one-way t-test to assess if acyclovir Cmax value is reduced after polysorbate 80 than after placebo.|||||<|0.05|||||||t-test, 1 sided|||||||<0.05
72432136|NCT04640571|144376769|EQUIVALENCE|Simple one-way t-test to assess if CDCA AUC value is reduced after polysorbate 80 than after placebo.|||||<|0.05|||||||t-test, 1 sided|||||||<0.05
72432137|NCT04640571|144376770|EQUIVALENCE|Simple one-way t-test to assess if CDCA Cmax value is reduced after polysorbate 80 than after placebo.|||||<|0.05|||||||t-test, 1 sided|||||||<0.05
72432138|NCT04640571|144376771|EQUIVALENCE|Simple one-way t-test to assess if enalaprilat AUC value is increased after polysorbate 80 than after placebo.|||||<|0.05|||||||t-test, 1 sided|||||||<0.05
72432139|NCT04640571|144376772|EQUIVALENCE|Simple one-way t-test to assess if enalaprilat Cmax value is increased after polysorbate 80 than after placebo.|||||<|0.05|||||||t-test, 1 sided|||||||<0.05
72432140|NCT04640571|144376773|EQUIVALENCE|For each of 15 endogenous bile acid, simple one-way t-test to assess if endogenous bile acid AUC value is larger after polysorbate 80 than after placebo.|||||<|0.05|||||||t-test, 1 sided|||||||<0.05
72616008|NCT01327703|144762565|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower bound of the 2-sided 95% confidence interval (CI) of Panzytrat® versus Kreon® exceeded -10%.|Treatment difference|-2.08||||0.459|TWO_SIDED|95.0|-7.23|4.02||As there was only a single pre-specified primary analysis, there was no adjustment for multiplicity.|Mixed Models Analysis|||Mixed model analysis method was used for comparison using log-transformed percent CFA as the response variable, fixed effect factors for treatment, period, treatment sequence and pooled site and participant within treatment sequence as a random effect.||4.02|-7.23|0.4590
72432141|NCT04640571|144376774|EQUIVALENCE|For each of 15 endogenous bile acid, simple one-way t-test to assess if endogenous bile acid Cmax value is reduced after metformin than after placebo.|||||<|0.05|||||||t-test, 1 sided|||||||<0.05
72432142|NCT04640571|144376775|EQUIVALENCE|For each of 15 endogenous bile acid, simple one-way t-test to assess if endogenous bile acid AUC value is reduced after metformin than after placebo.|||||<|0.05|||||||t-test, 1 sided|||||||<0.05
72432143|NCT04640571|144376776|EQUIVALENCE|For each of 15 endogenous bile acid, simple one-way t-test to assess if endogenous bile acid Cmax value is larger after polysorbate 80 than after placebo.|||||<|0.05|||||||t-test, 1 sided|||||||<0.05
72432144|NCT02783950|144376805|SUPERIORITY|||||||0.27|||||||Chi-squared|||||||0.27
72432145|NCT02783950|144376806|SUPERIORITY|||||||0.7|||||||Wilcoxon Rank Test p-value|||||||0.70
72432146|NCT04319094|144376811|SUPERIORITY||Mean Difference (Net)|-3.7|STANDARD_ERROR_OF_MEAN|0.55|<|0.0001|TWO_SIDED|95.0|-4.77|-2.62||The a priori threshold for statistical significance is p=0.05.|Mixed Models Analysis|Degrees of freedom: 501|Score difference = Post-intervention - Baseline|Null hypothesis: there is no difference in the mean Patient Health Questionnaire-9 (PHQ-9) scores from baseline to post-intervention for all study participants.|A series of generalized linear mixed-effect models were implemented to predict the outcome measurements. The primary fixed effect predictors were group (control vs. PEERS), time (categorical), and group \* time. Random terms in all models were: study participants and their interaction with time. The covariance of dependent variable values across time was modeled as a first-order auto-regression decaying function (AR1). Higher order fixed and random terms were pretested and removed from the model if nonsignificant.|-2.62|-4.77|<0.0001
72432147|NCT04319094|144376811|SUPERIORITY||Mean Difference (Net)|-2.53|STANDARD_ERROR_OF_MEAN|0.65||0.0001|TWO_SIDED|95.0|-3.81|-1.25||The a priori threshold for statistical significance is p=0.05.|Mixed Models Analysis|Degrees of freedom: 501|Score difference = 3-month - Baseline|Null hypothesis: there is no difference in the mean Patient Health Questionnaire-9 (PHQ-9) scores from baseline to 3-month for all study participants.|A series of generalized linear mixed-effect models were implemented to predict the outcome measurements. The primary fixed effect predictors were group (control vs. PEERS), time (categorical), and group \* time. Random terms in all models were: study participants and their interaction with time. The covariance of dependent variable values across time was modeled as a first-order auto-regression decaying function (AR1). Higher order fixed and random terms were pretested and removed from the model if nonsignificant.|-1.25|-3.81|0.0001
72432148|NCT04319094|144376811|SUPERIORITY||Median Difference (Net)|-2.83|STANDARD_ERROR_OF_MEAN|0.66|<|0.0001|TWO_SIDED|95.0|-4.13|-1.53||The a priori threshold for statistical significance is p=0.05.|Mixed Models Analysis|Degrees of freedom: 501|Score difference = 6-month - baseline|Null hypothesis: there is no difference in the mean Patient Health Questionnaire-9 (PHQ-9) scores from baseline to 6-month for all study participants.|A series of generalized linear mixed-effect models were implemented to predict the outcome measurements. The primary fixed effect predictors were group (control vs. PEERS), time (categorical), and group \* time. Random terms in all models were: study participants and their interaction with time. The covariance of dependent variable values across time was modeled as a first-order auto-regression decaying function (AR1). Higher order fixed and random terms were pretested and removed from the model if nonsignificant.|-1.53|-4.13|<0.0001
72432149|NCT04319094|144376811|SUPERIORITY||Mean Difference (Net)|-2.76|STANDARD_ERROR_OF_MEAN|0.65|<|0.0001|TWO_SIDED|95.0|-4.03|-1.49||The a priori threshold for statistical significance is p=0.05.|Mixed Models Analysis|Degrees of freedom: 501|Score difference = 9-month - baseline|Null hypothesis: there is no difference in the mean Patient Health Questionnaire-9 (PHQ-9) scores from baseline to 9-month for all study participants.|A series of generalized linear mixed-effect models were implemented to predict the outcome measurements. The primary fixed effect predictors were group (control vs. PEERS), time (categorical), and group \* time. Random terms in all models were: study participants and their interaction with time. The covariance of dependent variable values across time was modeled as a first-order auto-regression decaying function (AR1). Higher order fixed and random terms were pretested and removed from the model if nonsignificant.|-1.49|-4.03|<0.0001
72622175|NCT02592655|144774354|SUPERIORITY_OR_OTHER|||||||0.5||||||Significance thresh hold: 0.05.|McNemar|||"Null hypothesis is that using the pneumatic tourniquet is just as likely to occlude arterial flow as using two windlass tourniquets.~Participant count of 17 to accommodate for missing ultrasound data."||||0.5
72622176|NCT03996395|144774357|OTHER||Descriptive statistic|71.0|STANDARD_DEVIATION|23.0|||TWO_SIDED|||||||||||||
72432150|NCT04319094|144376811|SUPERIORITY||Mean Difference (Net)|-2.56|STANDARD_ERROR_OF_MEAN|0.71||0.0003|TWO_SIDED|95.0|-3.95|-1.17||The a priori threshold for statistical significance is p=0.05.|Mixed Models Analysis|Degrees of freedom: 501|Score difference =12-month - baseline|Null hypothesis: there is no difference in the mean Patient Health Questionnaire-9 (PHQ-9) scores from baseline to 12-month for all study participants.|A series of generalized linear mixed-effect models were implemented to predict the outcome measurements. The primary fixed effect predictors were group (control vs. PEERS), time (categorical), and group \* time. Random terms in all models were: study participants and their interaction with time. The covariance of dependent variable values across time was modeled as a first-order auto-regression decaying function (AR1). Higher order fixed and random terms were pretested and removed from the model if nonsignificant.|-1.17|-3.95|0.0003
72432151|NCT04319094|144376811|SUPERIORITY|||||||0.4375|||||||Mixed Models Analysis|||Null hypothesis: There is no difference in the change of PHQ-9 over time between the control and PEERS participants.||||0.4375
72432152|NCT04319094|144376812|SUPERIORITY||Mean Difference (Net)|1.61|STANDARD_ERROR_OF_MEAN|2.42||0.51|TWO_SIDED|95.0|-3.15|6.37||The a priori threshold for statistical significance is p=0.05.|Mixed Models Analysis|Degrees of freedom: 364||Null hypothesis: there is no difference in the mean SF36 - Physical Functioning scores from baseline to post-intervention for all study participants.|A series of generalized linear mixed-effect models were implemented to predict the outcome measurements. The primary fixed effect predictors were group (control vs. PEERS), time (categorical), and group \* time. Random terms in all models were: study participants and their interaction with time. The covariance of dependent variable values across time was modeled as a first-order auto-regression decaying function (AR1). Higher order fixed and random terms were pretested and removed from the model if nonsignificant.|6.37|-3.15|0.51
72432153|NCT04319094|144376812|SUPERIORITY||Mean Difference (Net)|4.57||||0.18|TWO_SIDED|95.0|-2.08|11.21||The a priori threshold for statistical significance is p=0.05.|Mixed Models Analysis|Degrees of freedom: 364||Null hypothesis: there is no difference in the mean SF36-physical function scores from baseline to 3-month for all study participants.|A series of generalized linear mixed-effect models were implemented to predict the outcome measurements. The primary fixed effect predictors were group (control vs. PEERS), time (categorical), and group \* time. Random terms in all models were: study participants and their interaction with time. The covariance of dependent variable values across time was modeled as a first-order auto-regression decaying function (AR1). Higher order fixed and random terms were pretested and removed from the model if nonsignificant.|11.21|-2.08|0.18
72432154|NCT04319094|144376812|SUPERIORITY||Mean Difference (Net)|1.57|STANDARD_ERROR_OF_MEAN|3.29||0.63|TWO_SIDED|95.0|-4.89|8.04||The a priori threshold for statistical significance is p=0.05.|Mixed Models Analysis|Degrees of freedom: 364||Null hypothesis: there is no difference in the mean SF36-physical function scores from baseline to 6-month for all study participants.|A series of generalized linear mixed-effect models were implemented to predict the outcome measurements. The primary fixed effect predictors were group (control vs. PEERS), time (categorical), and group \* time. Random terms in all models were: study participants and their interaction with time. The covariance of dependent variable values across time was modeled as a first-order auto-regression decaying function (AR1). Higher order fixed and random terms were pretested and removed from the model if nonsignificant.|8.04|-4.89|0.63
72432155|NCT04319094|144376812|SUPERIORITY||Mean Difference (Net)|-1.02|STANDARD_ERROR_OF_MEAN|3.01||0.74|TWO_SIDED|95.0|-6.94|4.91||The a priori threshold for statistical significance is p=0.05.|Mixed Models Analysis|Degrees of freedom: 364||Null hypothesis: there is no difference in the mean SF36-physical function scores from baseline to 9-month for all study participants.|A series of generalized linear mixed-effect models were implemented to predict the outcome measurements. The primary fixed effect predictors were group (control vs. PEERS), time (categorical), and group \* time. Random terms in all models were: study participants and their interaction with time. The covariance of dependent variable values across time was modeled as a first-order auto-regression decaying function (AR1). Higher order fixed and random terms were pretested and removed from the model if nonsignificant.|4.91|-6.94|0.74
72432156|NCT04319094|144376812|SUPERIORITY||Mean Difference (Net)|0.7|STANDARD_ERROR_OF_MEAN|3.83||0.85|TWO_SIDED|95.0|-6.82|8.23||The a priori threshold for statistical significance is p=0.05.|Mixed Models Analysis|Degrees of freedom: 364||Null hypothesis: there is no difference in the mean SF36-physical function scores from baseline to 12-month for all study participants.|A series of generalized linear mixed-effect models were implemented to predict the outcome measurements. The primary fixed effect predictors were group (control vs. PEERS), time (categorical), and group \* time. Random terms in all models were: study participants and their interaction with time. The covariance of dependent variable values across time was modeled as a first-order auto-regression decaying function (AR1). Higher order fixed and random terms were pretested and removed from the model if nonsignificant.|8.23|-6.82|0.85
72432157|NCT04319094|144376812|SUPERIORITY|||||||0.3988|||||||Mixed Models Analysis|||Null hypothesis: There is no difference in the change of physical functioning over time between the control and PEERS participants.||||0.3988
72432158|NCT04319094|144376813|SUPERIORITY||Mean Difference (Net)|5.08|STANDARD_ERROR_OF_MEAN|3.41||0.14|TWO_SIDED|95.0|-1.63|11.79||The a priori threshold for statistical significance is p=0.05.|Mixed Models Analysis|Degrees of freedom: 360||Null hypothesis: there is no difference in the mean SF36-social function scores from baseline to post-intervention for all study participants.|A series of generalized linear mixed-effect models were implemented to predict the outcome measurements. The primary fixed effect predictors were group (control vs. PEERS), time (categorical), and group \* time. Random terms in all models were: study participants and their interaction with time. The covariance of dependent variable values across time was modeled as a first-order auto-regression decaying function (AR1). Higher order fixed and random terms were pretested and removed from the model if nonsignificant.|11.79|-1.63|0.14
72622177|NCT05135754|144774387|SUPERIORITY||Risk Ratio (RR)|0.59||||0.046|TWO_SIDED|95.0|0.35|0.99|||Mixed Models Analysis|||||0.99|0.35|0.046
72622178|NCT05135754|144774388|SUPERIORITY||Mean Difference (Final Values)|6.61|||<|0.001|TWO_SIDED|95.0|3.45|9.78|||Mixed Models Analysis|||||9.78|3.45|<0.001
72622179|NCT05135754|144774389|SUPERIORITY||Mean Difference (Final Values)|20.01|||<|0.001|TWO_SIDED|95.0|15.02|25.0|||Mixed Models Analysis|||||25.00|15.02|<0.001
72622180|NCT05135754|144774390|SUPERIORITY||Mean Difference (Final Values)|6.32|||<|0.001|TWO_SIDED|95.0|2.71|9.94|||Mixed Models Analysis|||||9.94|2.71|<0.001
72432159|NCT04319094|144376813|SUPERIORITY||Mean Difference (Net)|10.32|STANDARD_ERROR_OF_MEAN|4.0||0.01|TWO_SIDED|95.0|2.45|18.19||The a priori threshold for statistical significance is p=0.05.|Mixed Models Analysis|Degrees of freedom: 360||Null hypothesis: there is no difference in the mean SF36-social function scores from baseline to 3-month for all study participants.|A series of generalized linear mixed-effect models were implemented to predict the outcome measurements. The primary fixed effect predictors were group (control vs. PEERS), time (categorical), and group \* time. Random terms in all models were: study participants and their interaction with time. The covariance of dependent variable values across time was modeled as a first-order auto-regression decaying function (AR1). Higher order fixed and random terms were pretested and removed from the model if nonsignificant.|18.19|2.45|0.01
72504419|NCT01855789|144539437|SUPERIORITY||Low DAS28 Rate Difference|-13.6||||0.0228|TWO_SIDED|95.0|-24.0|-3.3|||Cochran-Mantel-Haenszel||TCZ + PBO minus TCZ + MTX|Week 40: Analysis of association between treatment group and response, stratified by the randomization stratification factors: DAS28 remission status at Week 24 (\<2.6, \>=2.6 to \<=3.2), baseline weight-by-dosing group (\<80 kg q2w, \<80 kg qw, 80-\<100 kg q2w, 80-\<100 kg qw, \>=100 kg qw), participant anti-TNF exposure (Yes/No).||-3.3|-24.0|0.0228
72371460|NCT01215097|144253322|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.243|||<|0.0001||95.0|2.831|13.769|||Regression, Logistic|The odds-ratio is based on a logistic regression model including baseline HbA1c and previous antidiabetic medication||Comparison by odds ratio for the patients with a baseline HbA1c \>=7.0%||13.769|2.831|<0.0001
72371461|NCT01215097|144253324|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.97||||0.0129||95.0|1.404|17.592|||Regression, Logistic|The odds-ratio is based on a logistic regression model including baseline HbA1c and previous antidiabetic medication||Comparison by odds ratio for the patients with a baseline HbA1c \>= 6.5%||17.592|1.404|0.0129
72371462|NCT01215097|144253325|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.054|||<|0.0001||95.0|1.799|5.185|||Regression, Logistic|The odds-ratio is based on a logistic regression model including baseline HbA1c and previous antidiabetic medication||Comparison by odds ratio for the patients with HbA1c at least lowering 0.5% from baseline||5.185|1.799|<0.0001
72371463|NCT01001325|144253331|SUPERIORITY_OR_OTHER|||||||0.685||95.0|||||Fisher Exact|||"Null hypothesis: There is no difference in incidence of pandemic strain influenza infection for people given seasonal influenza vaccine compared to those given a placebo.~Power to detect a 2-fold difference if attack rate in non-vaccinated participants is 10%: 86%"||||0.685
72371464|NCT01584440|144253332|SUPERIORITY||Ordinary Least Squares (OLS) Z-statistic|-1.5|||<=|0.001|TWO_SIDED||||||ANCOVA|Sequential Parallel Comparison Design (SPCD): data from the Stages 1 and 2 are analyzed together using the mITT Population||||||<=0.001
72371465|NCT01584440|144253332|SUPERIORITY||ANCOVA Least Squares Mean Difference|-1.5|||||TWO_SIDED||||||||Day 36|||||
72371466|NCT01584440|144253332|SUPERIORITY||ANCOVA Least Squares Mean Difference|-1.59|||||TWO_SIDED||||||||Day 70|||||
72371467|NCT01584440|144253334|SUPERIORITY||OLS Z-statistic|-2.46||||0.014|TWO_SIDED||||||ANCOVA|SPCD: data from the Stages 1 and 2 are analyzed together using the mITT Population||||||0.014
72371468|NCT01584440|144253334|SUPERIORITY||ANCOVA Least Squares Mean Difference|-4.2|||||TWO_SIDED||||||||||Day 36|||
72371469|NCT01584440|144253334|SUPERIORITY||ANCOVA Least Squares Mean Difference|-3.78|||||TWO_SIDED||||||||Day 70|||||
72371470|NCT01584440|144253335|SUPERIORITY||OLS Z-statistic|0.77||||0.444|TWO_SIDED||||||ANCOVA|Delusions Domain. SPCD: data from the Stages 1 and 2 are analyzed together using the mITT Population||||||0.444
72371471|NCT01584440|144253335|SUPERIORITY||ANCOVA Least Squares Mean Difference|-0.27|||||TWO_SIDED||||||||Delusions Domain; Day 36|||||
72371472|NCT01584440|144253335|SUPERIORITY||ANCOVA Least Squares Mean Difference|0.78|||||TWO_SIDED||||||||Delusions Domain; Day 70|||||
72371473|NCT01584440|144253335|SUPERIORITY||OLS Z-statistic|-0.18||||0.861|TWO_SIDED||||||ANCOVA|Hallucinations Domain. SPCD: data from the Stages 1 and 2 are analyzed together using the mITT Population||||||0.861
72371474|NCT01584440|144253335|SUPERIORITY||ANCOVA Least Squares Mean Difference|-0.29|||||TWO_SIDED||||||||Hallucinations Domain; Day 36|||||
72371475|NCT01584440|144253335|SUPERIORITY||ANCOVA Least Squares Mean Difference|0.22|||||TWO_SIDED||||||||Hallucinations Domain; Day 70|||||
72371476|NCT01584440|144253335|SUPERIORITY||OLS Z-statistic|-0.32||||0.749|TWO_SIDED||||||ANCOVA|Depression/Dysphoria Domain. SPCD: data from the Stages 1 and 2 are analyzed together using the mITT Population||||||0.749
72371477|NCT01584440|144253335|SUPERIORITY||ANCOVA Least Squares Mean Difference|-0.07|||||TWO_SIDED||||||||Depression/Dysphoria Domain; Day 36|||||
72371478|NCT01584440|144253335|SUPERIORITY||ANCOVA Least Squares Mean Difference|-0.1|||||TWO_SIDED||||||||Depression/Dysphoria Domain; Day 70|||||
72371479|NCT01584440|144253335|SUPERIORITY||OLS Z-statistic|-0.81||||0.416|TWO_SIDED||||||ANCOVA|Anxiety Domain. SPCD: data from the Stages 1 and 2 are analyzed together using the mITT Population||||||0.416
72371480|NCT01584440|144253335|SUPERIORITY||ANCOVA Least Squares Mean Difference|0.28|||||TWO_SIDED||||||||Anxiety Domain; Day 36|||||
72371481|NCT01584440|144253335|SUPERIORITY||ANCOVA Least Squares Mean Difference|-0.81|||||TWO_SIDED||||||||Anxiety Domain|||||
72371482|NCT01584440|144253335|SUPERIORITY||OLS Z-statistic|-1.07||||0.287|TWO_SIDED||||||ANCOVA|Euphoria/Elation Domain. SPCD: data from the Stages 1 and 2 are analyzed together using the mITT Population||||||0.287
72371483|NCT01584440|144253335|SUPERIORITY||ANCOVA Least Squares Mean Difference|0.04|||||TWO_SIDED||||||||Euphoria/Elation Domain; Day 36|||||
72371484|NCT01584440|144253335|SUPERIORITY||ANCOVA Least Squares Mean Difference|-0.34|||||TWO_SIDED||||||||Euphoria/Elation Domain; Day 70|||||
72371485|NCT01584440|144253335|SUPERIORITY||OLS Z-statistic|-1.31||||0.191|TWO_SIDED||||||ANCOVA|Apathy/Indifference Domain. SPCD: data from the Stages 1 and 2 are analyzed together using the mITT Population||||||0.191
72371486|NCT01584440|144253335|SUPERIORITY||ANCOVA Least Squares Mean Difference|-0.16|||||TWO_SIDED||||||||Apathy/Indifference Domain; Day 36|||||
72371487|NCT01584440|144253335|SUPERIORITY||ANCOVA Least Squares Mean Difference|-0.77|||||TWO_SIDED||||||||Apathy/Indifference Domain; Day 36|||||
72371488|NCT01584440|144253335|SUPERIORITY||OLS Z-statistic|-1.1||||0.271|TWO_SIDED||||||ANCOVA|Disinhibition Domain. SPCD: data from the Stages 1 and 2 are analyzed together using the mITT Population||||||0.271
72371489|NCT01584440|144253335|SUPERIORITY||ANCOVA Least Squares Mean Difference|-0.22|||||TWO_SIDED||||||||Disinhibition Domain; Day 36|||||
72616009|NCT00849472|144762607|SUPERIORITY_OR_OTHER||Percentage of participants|17.98|||||TWO_SIDED|95.0|10.64|27.55|||||The estimated value (EV) represents the percentage of participants with pCR. Participants with missing data were excluded from the denominator (n=89; 4 participants with missing data) for the calculation of the EV.|||27.55|10.64|
72371490|NCT01584440|144253335|SUPERIORITY||ANCOVA Least Squares Mean Difference|-0.37|||||TWO_SIDED||||||||Disinhibition Domain; Day 70|||||
72371491|NCT01584440|144253335|SUPERIORITY||OLS Z-statistic|-2.18||||0.029|TWO_SIDED||||||ANCOVA|Irritability/Lability Domain. SPCD: data from the Stages 1 and 2 are analyzed together using the mITT Population||||||0.029
72371492|NCT01584440|144253335|SUPERIORITY||ANCOVA Least Squares Mean Difference|-0.7|||||TWO_SIDED||||||||Irritability/Lability Domain; Day 36|||||
72371493|NCT01584440|144253335|SUPERIORITY||ANCOVA Least Squares Mean Difference|-0.93|||||TWO_SIDED||||||||Irritability/Lability Domain; Day 70|||||
72371494|NCT01584440|144253335|SUPERIORITY||OLS Z-statistic|-2.21||||0.027|TWO_SIDED||||||ANCOVA|Aberrant Motor Behavior Domain. SPCD: data from the Stages 1 and 2 are analyzed together using the mITT Population||||||0.027
72371495|NCT01584440|144253335|SUPERIORITY||ANCOVA Least Squares Mean Difference|-0.38|||||TWO_SIDED||||||||Aberrant Motor Behavior Domain; Day 36|||||
72371496|NCT01584440|144253335|SUPERIORITY||ANCOVA Least Squares Mean Difference|-1.22|||||TWO_SIDED||||||||Aberrant Motor Behavior Domain; Day 70|||||
72371497|NCT01584440|144253335|SUPERIORITY||OLS Z-statistic|-1.09||||0.274|TWO_SIDED||||||ANCOVA|Sleep/Nighttime Behavior Disorders Domain. SPCD: data from the Stages 1 and 2 are analyzed together using the mITT Population||||||0.274
72371498|NCT01584440|144253335|SUPERIORITY||ANCOVA Least Squares Mean Difference|-0.57|||||TWO_SIDED||||||||Sleep/Nighttime Behavior disorders Domain; Day 36|||||
72371499|NCT01584440|144253335|SUPERIORITY||ANCOVA Least Squares Mean Difference|-0.08|||||TWO_SIDED||||||||Sleep/Nighttime Behavior disorders Domain; Day 70|||||
72371500|NCT01584440|144253335|SUPERIORITY||OLS Z-statistic|-0.65||||0.513|TWO_SIDED||||||ANCOVA|Appetite/Eating Changes Domain. SPCD: data from the Stages 1 and 2 are analyzed together using the mITT Population||||||0.513
72371501|NCT01584440|144253335|SUPERIORITY||ANCOVA Least Squares Mean Difference|-0.16|||||TWO_SIDED||||||||Appetite/Eating Changes Domain; Day 36|||||
72371502|NCT01584440|144253335|SUPERIORITY||ANCOVA Least Squares Mean Difference|-0.24|||||TWO_SIDED||||||||Appetite/Eating Changes Domain; Day 70|||||
72371503|NCT01584440|144253336|SUPERIORITY||OLS Z-statistic|-3.53|||<=|0.001|TWO_SIDED||||||ANCOVA|SPCD: data from the Stages 1 and 2 are analyzed together using the mITT Population||||||<=0.001
72371504|NCT01584440|144253336|SUPERIORITY||ANCOVA Least Squares Mean Difference|-3.01|||||TWO_SIDED||||||||Day 36|||||
72371505|NCT01584440|144253336|SUPERIORITY||ANCOVA Least Squares Mean Difference|-3.49|||||TWO_SIDED||||||||Day 70|||||
72371506|NCT01584440|144253337|SUPERIORITY||OLS Z-statistic|-3.34||||0.001|TWO_SIDED||||||ANCOVA|SPCD: data from the Stages 1 and 2 are analyzed together using the mITT Population||||||0.001
72371507|NCT01584440|144253337|SUPERIORITY||ANCOVA Least Squares Mean Difference|-2.41|||||TWO_SIDED||||||||Day 36|||||
72371508|NCT01584440|144253337|SUPERIORITY||ANCOVA Least Squares Mean Difference|-3.94|||||TWO_SIDED||||||||Day 70|||||
72371509|NCT01584440|144253338|SUPERIORITY||OLS Z-statistic|-2.46||||0.014|TWO_SIDED||||||ANCOVA|SPCD: data from the Stages 1 and 2 are analyzed together using the mITT Population||||||0.014
72371510|NCT01584440|144253338|SUPERIORITY||ANCOVA Least Squares Mean Difference|-2.65|||||TWO_SIDED||||||||Day 36|||||
72371511|NCT01584440|144253338|SUPERIORITY||ANCOVA Least Squares Mean Difference|-1.01|||||TWO_SIDED||||||||||Day 70|||
72371512|NCT01584440|144253339|SUPERIORITY||OLS Z-statistic|-2.57||||0.01|TWO_SIDED||||||ANCOVA|SPCD: data from the Stages 1 and 2 are analyzed together using the mITT Population||||||0.010
72371513|NCT01584440|144253339|SUPERIORITY||ANCOVA Least Squares Mean Difference|-0.68|||||TWO_SIDED||||||||Day 36|||||
72371514|NCT01584440|144253339|SUPERIORITY||ANCOVA Least Squares Mean Difference|-0.2|||||TWO_SIDED||||||||Day 70|||||
72371515|NCT01584440|144253340|SUPERIORITY||OLS Z-statistic|-3.08||||0.002|TWO_SIDED||||||ANCOVA|SPCD: data from the Stages 1 and 2 are analyzed together using the mITT Population||||||0.002
72371516|NCT01584440|144253340|SUPERIORITY||ANCOVA Least Squares Mean Difference|-1.56|||||TWO_SIDED||||||||Day 36|||||
72371517|NCT01584440|144253340|SUPERIORITY||ANCOVA Least Squares Mean Difference|-0.9|||||TWO_SIDED||||||||Day 70|||||
72371518|NCT01584440|144253341|SUPERIORITY||OLS Z-statistic|-2.66||||0.008|TWO_SIDED||||||ANCOVA|SPCD: data from the Stages 1 and 2 are analyzed together using the mITT Population||||||0.008
72371519|NCT01584440|144253341|SUPERIORITY||ANCOVA Least Squares Mean Difference|-1.43|||||TWO_SIDED||||||||Day 36|||||
72371520|NCT01584440|144253341|SUPERIORITY||ANCOVA Least Squares Mean Difference|-0.75|||||TWO_SIDED||||||||Day 70|||||
72371521|NCT01584440|144253342|SUPERIORITY||OLS Z-statistic|-1.96||||0.05|TWO_SIDED||||||ANCOVA|SPCD: data from the Stages 1 and 2 are analyzed together using the mITT Population||||||0.050
72371522|NCT01584440|144253342|SUPERIORITY||ANCOVA Least Squares Mean Difference|-0.62|||||TWO_SIDED||||||||Day 36|||||
72371523|NCT01584440|144253342|SUPERIORITY||ANCOVA Least Squares Mean Difference|-0.3|||||TWO_SIDED||||||||Day 70|||||
72371524|NCT01584440|144253343|SUPERIORITY||OLS Z-statistic|-2.33||||0.02|TWO_SIDED||||||ANCOVA|SPCD: data from the Stages 1 and 2 are analyzed together using the mITT Population||||||0.020
72371525|NCT01584440|144253343|SUPERIORITY||ANCOVA Least Squares Mean Difference|-1.57|||||TWO_SIDED||||||||Day 36|||||
72371526|NCT01584440|144253343|SUPERIORITY||ANCOVA Least Squares Mean Difference|-0.18|||||TWO_SIDED||||||||Day 70|||||
72371527|NCT01584440|144253344|SUPERIORITY||OLS Z-statistic|1.94||||0.053|TWO_SIDED||||||ANCOVA|SPCD: data from the Stages 1 and 2 are analyzed together using the mITT Population||||||0.053
72371528|NCT01584440|144253344|SUPERIORITY||ANCOVA Least Squares Mean Difference|0.52|||||TWO_SIDED||||||||Day 36|||||
72371529|NCT01584440|144253344|SUPERIORITY||ANCOVA Least Squares Mean Difference|0.84|||||TWO_SIDED||||||||Day 70|||||
72371530|NCT01584440|144253345|SUPERIORITY||OLS Z-statistic|-0.72||||0.469|TWO_SIDED||||||ANCOVA|SPCD: data from the Stages 1 and 2 are analyzed together using the mITT Population|Caregiver|||||0.469
72371531|NCT01584440|144253345|SUPERIORITY||ANCOVA Least Squares Mean Difference|0.28|||||TWO_SIDED||||||||Caregiver: Day 36|||||
72616010|NCT01257438|144762629|SUPERIORITY_OR_OTHER||Greenwood's estimate of variance|0.59|||<|0.001|TWO_SIDED|95.0|0.44|0.79|||Log Rank|||Subjects at risk (at 6 months) is a calculation in Kaplan-Meier time-to-event analyses that refers to subjects who have not had ACPP failure through the 6 months (i.e., are event-free through 6 months).||0.79|0.44|<0.001
72616011|NCT01257438|144762630|NON_INFERIORITY_OR_EQUIVALENCE|The p-value is based on a non-inferiority Farrington and Manning Exact Test. The non-inferiority margin is 0.075 (or 7.5%).||||||0.007|TWO_SIDED||||||Farrington and Manning Exact Test|The non-inferiority margin is 0.075 (or 7.5%)||||||0.007
72371532|NCT01584440|144253345|SUPERIORITY||ANCOVA Least Squares Mean Difference|-1.06|||||TWO_SIDED||||||||Caregiver: Day 70|||||
72371533|NCT01584440|144253345|SUPERIORITY||OLS Z-statistic|1.41||||0.159|TWO_SIDED||||||ANCOVA|SPCD: data from the Stages 1 and 2 are analyzed together using the mITT Population|Participant|||||0.159
72371534|NCT01584440|144253345|SUPERIORITY||ANCOVA Least Squares Mean Difference|1.09|||||TWO_SIDED||||||||Participant: Day 36|||||
72371535|NCT01584440|144253345|SUPERIORITY||ANCOVA Least Squares Mean Difference|0.7|||||TWO_SIDED||||||||Participant: Day 70|||||
72371536|NCT01584440|144253346|SUPERIORITY||OLS Z-statistic|-1.4||||0.163|TWO_SIDED||||||ANCOVA|SPCD: data from the Stages 1 and 2 are analyzed together using the mITT Population||||||0.163
72371537|NCT01584440|144253346|SUPERIORITY||ANCOVA Least Squares Mean Difference|-0.07|||||TWO_SIDED||||||||Day 36|||||
72371538|NCT01584440|144253346|SUPERIORITY||ANCOVA Least Squares Mean Difference|-1.39|||||TWO_SIDED||||||||Day 70|||||
72371539|NCT01584440|144253347|SUPERIORITY||OLS Z-statistic|-1.08||||0.279|TWO_SIDED||||||ANCOVA|SPCD: data from the Stages 1 and 2 are analyzed together using the mITT Population||||||0.279
72371540|NCT01584440|144253347|SUPERIORITY||ANCOVA Least Squares Mean Difference|-0.76|||||TWO_SIDED||||||||Day 8|||||
72371541|NCT01584440|144253347|SUPERIORITY||ANCOVA Least Squares Mean Difference|-1.02|||||TWO_SIDED||||||||Day 22|||||
72371542|NCT01584440|144253347|SUPERIORITY||ANCOVA Least Squares Mean Difference|0.74|||||TWO_SIDED||||||||Day 43|||||
72371543|NCT01584440|144253347|SUPERIORITY||ANCOVA Least Squares Mean Difference|-0.05|||||TWO_SIDED||||||||Day 57|||||
72371544|NCT01584440|144253348|SUPERIORITY||Odds Ratio (OR)|2.7||||0.0001|TWO_SIDED|95.0|1.62|4.5|||ANCOVA||Day 36|||4.50|1.62|0.0001
72371545|NCT01584440|144253348|SUPERIORITY||Odds Ratio (OR)|1.61||||0.2184|TWO_SIDED|95.0|0.75|3.43|||ANCOVA||Day 70|||3.43|0.75|0.2184
72371546|NCT01584440|144253349|SUPERIORITY||Odds Ratio (OR)|2.45||||0.0266|TWO_SIDED|95.0|1.11|5.42|||ANCOVA|||||5.42|1.11|0.0266
72371547|NCT01584440|144253350|SUPERIORITY||Odds Ratio (OR)|2.16||||0.002|TWO_SIDED|95.0|1.31|3.55|||ANCOVA||Day 36|||3.55|1.31|0.002
72371548|NCT01584440|144253350|SUPERIORITY||Odds Ratio (OR)|2.32||||0.031|TWO_SIDED|95.0|1.08|5.0|||ANCOVA||Day 70|||5.00|1.08|0.031
72616012|NCT04180696|144762654|SUPERIORITY|Endpoint for statistical analysis is the proportion Improved.||||||0.61|||||||Chi-squared|||||||0.61
72371549|NCT01584440|144253351|SUPERIORITY||Odds Ratio (OR)|2.41||||0.0048|TWO_SIDED|95.0|1.31|4.46|||ANCOVA|||||4.46|1.31|0.0048
72371550|NCT00531427|144253360|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.37||||0.0853|TWO_SIDED|95.0|-0.8|0.05|||Mixed Models Analysis|Statistics are based on a mixed effect general linear model||"\[Week 12 analysis\] The null hypothesis was no group differences. The alternative hypothesis was that BTDS arm was superior to the placebo arm.~Pain scale is 11 points (0 = no pain to 10 = pain as bad as you can imagine)."||0.05|-0.80|0.0853
72371551|NCT00531427|144253361|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.037||||0.7098|TWO_SIDED|95.0|-0.233|0.159||To control multiplicity and family-wise error rate, a gate-keeping strategy (stepwise approach) was used to evaluate the statistical significance of the secondary variables. If the primary is negative, the secondary P values are descriptive only.|ANCOVA|with treatment as a factor and screening and pre-randomization mean pain as covariates.||Categorical analysis P value is based on a Fisher's exact test. Mean daily number of tablets for subjects who took \<=1 dose of supplemental analgesia||0.159|-0.233|0.7098
72371552|NCT00531427|144253362|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.46||||0.0034|TWO_SIDED|95.0|-7.44|-1.48||To control multiplicity and family-wise error rate, a gate-keeping strategy (stepwise approach) was used to evaluate the statistical significance of the secondary variables. If the primary is negative, the secondary P values are descriptive only.|Mixed Models Analysis|||Weeks 4, 8, 12 analysis The sleep disturbance subscale was analyzed using the mixed effect linear model with fixed effects for treatment (BTDS or placebo) and time (weeks 1, 2, 4, 8, 12) as categorical, screening mean and prerandomization mean value as covariates, and subject as a random effect.||-1.48|-7.44|0.0034
72371553|NCT00669409|144253437|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-2.0|STANDARD_ERROR_OF_MEAN|7.98|||TWO_SIDED|95.0|-17.8|13.8||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||13.8|-17.8|
72371554|NCT00669409|144253437|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-18.5|STANDARD_ERROR_OF_MEAN|7.98|||TWO_SIDED|95.0|-34.3|-2.8||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-2.8|-34.3|
72371555|NCT00669409|144253437|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-2.7|STANDARD_ERROR_OF_MEAN|7.99|||TWO_SIDED|95.0|-18.5|13.1||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||13.1|-18.5|
72371556|NCT00669409|144253437|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-13.8|STANDARD_ERROR_OF_MEAN|7.88|||TWO_SIDED|95.0|-29.4|1.8||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||1.8|-29.4|
72371557|NCT00669409|144253437|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-34.5|STANDARD_ERROR_OF_MEAN|10.48|||TWO_SIDED|95.0|-55.2|-13.7||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-13.7|-55.2|
72371558|NCT00669409|144253438|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-3.6|STANDARD_ERROR_OF_MEAN|7.98|||TWO_SIDED|95.0|-19.4|12.2||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||12.2|-19.4|
72371559|NCT00669409|144253438|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-15.0|STANDARD_ERROR_OF_MEAN|7.98|||TWO_SIDED|95.0|-30.8|0.8||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||0.8|-30.8|
72616013|NCT04180696|144762655|SUPERIORITY||Odds Ratio (OR)|1.192|STANDARD_ERROR_OF_MEAN|0.367||0.63|TWO_SIDED|95.0|0.579|2.455|||Regression, Logistic|Proportional odds logistic regression model. Baseline NYHA class and time included as fixed covariates.||Due to limited number of subjects with NYHA class III or IV during follow-up, class III, IV, and death were grouped as a single category for analysis.||2.455|0.579|0.63
72371560|NCT00669409|144253438|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|4.1|STANDARD_ERROR_OF_MEAN|7.99|||TWO_SIDED|95.0|-11.7|19.9||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||19.9|-11.7|
72371561|NCT00669409|144253438|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-11.0|STANDARD_ERROR_OF_MEAN|7.88|||TWO_SIDED|95.0|-26.6|4.6||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||4.6|-26.6|
72371562|NCT00669409|144253438|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-9.8|STANDARD_ERROR_OF_MEAN|10.48|||TWO_SIDED|95.0|-30.5|10.9||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||10.9|-30.5|
72371563|NCT00669409|144253439|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-3.6|STANDARD_ERROR_OF_MEAN|7.98|||TWO_SIDED|95.0|-19.4|12.2||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||12.2|-19.4|
72432160|NCT04319094|144376813|SUPERIORITY||Mean Difference (Net)|10.25|STANDARD_ERROR_OF_MEAN|4.19||0.015|TWO_SIDED|95.0|2.01|18.5||The a priori threshold for statistical significance is p=0.05.|Mixed Models Analysis|Degrees of freedom: 360||Null hypothesis: there is no difference in the mean SF36-social function scores from baseline to 6-month for all study participants.|A series of generalized linear mixed-effect models were implemented to predict the outcome measurements. The primary fixed effect predictors were group (control vs. PEERS), time (categorical), and group \* time. Random terms in all models were: study participants and their interaction with time. The covariance of dependent variable values across time was modeled as a first-order auto-regression decaying function (AR1). Higher order fixed and random terms were pretested and removed from the model if nonsignificant.|18.5|2.01|0.015
72432161|NCT04319094|144376813|SUPERIORITY||Mean Difference (Net)|11.72|STANDARD_ERROR_OF_MEAN|4.07||0.004|TWO_SIDED|95.0|3.7|19.73||The a priori threshold for statistical significance is p=0.05.|Mixed Models Analysis|degrees of freedom: 360||Null hypothesis: there is no difference in the mean SF36-social function scores from baseline to 9-month for all study participants.|A series of generalized linear mixed-effect models were implemented to predict the outcome measurements. The primary fixed effect predictors were group (control vs. PEERS), time (categorical), and group \* time. Random terms in all models were: study participants and their interaction with time. The covariance of dependent variable values across time was modeled as a first-order auto-regression decaying function (AR1). Higher order fixed and random terms were pretested and removed from the model if nonsignificant.|19.73|3.7|0.004
72432162|NCT04319094|144376813|SUPERIORITY||Mean Difference (Net)|5.73|STANDARD_ERROR_OF_MEAN|4.49||0.2|TWO_SIDED|95.0|-3.09|14.55||The a priori threshold for statistical significance is p=0.05.|Mixed Models Analysis|Degrees of freedom: 360||Null hypothesis: there is no difference in the mean SF36-social function scores from baseline to 12-month for all study participants.|A series of generalized linear mixed-effect models were implemented to predict the outcome measurements. The primary fixed effect predictors were group (control vs. PEERS), time (categorical), and group \* time. Random terms in all models were: study participants and their interaction with time. The covariance of dependent variable values across time was modeled as a first-order auto-regression decaying function (AR1). Higher order fixed and random terms were pretested and removed from the model if nonsignificant.|14.55|-3.09|0.2
72432163|NCT04319094|144376813|SUPERIORITY|||||||0.8037|||||||Mixed Models Analysis|||Null hypothesis: There is no difference in the change of social functioning over time between the control and PEERS participants.||||0.8037
72432164|NCT04319094|144376814|SUPERIORITY||Median Difference (Net)|12.52|STANDARD_ERROR_OF_MEAN|5.01||0.0129|TWO_SIDED|95.0|2.67|22.37||The a priori threshold for statistical significance is p=0.05.|Mixed Models Analysis|Degrees of freedom: 366||Null hypothesis: there is no difference in the mean SF36-emotional functioning scores from baseline to post-intervention for all study participants.|A series of generalized linear mixed-effect models were implemented to predict the outcome measurements. The primary fixed effect predictors were group (control vs. PEERS), time (categorical), and group \* time. Random terms in all models were: study participants and their interaction with time. The covariance of dependent variable values across time was modeled as a first-order auto-regression decaying function (AR1). Higher order fixed and random terms were pretested and removed from the model if nonsignificant.|22.37|2.67|0.0129
72432165|NCT04319094|144376814|SUPERIORITY||Mean Difference (Net)|19.84|STANDARD_ERROR_OF_MEAN|5.86||0.0008|TWO_SIDED|95.0|8.32|31.36||The a priori threshold for statistical significance is p=0.05.|Mixed Models Analysis|Degrees of freedom: 366||Null hypothesis: there is no difference in the mean SF36-emotional functioning scores from baseline to 3-month for all study participants.|A series of generalized linear mixed-effect models were implemented to predict the outcome measurements. The primary fixed effect predictors were group (control vs. PEERS), time (categorical), and group \* time. Random terms in all models were: study participants and their interaction with time. The covariance of dependent variable values across time was modeled as a first-order auto-regression decaying function (AR1). Higher order fixed and random terms were pretested and removed from the model if nonsignificant.|31.36|8.32|0.0008
72504420|NCT01855789|144539437|SUPERIORITY||Low DAS28 Rate Difference|-5.4||||0.3665|TWO_SIDED|95.0|-16.3|5.4|||Cochran-Mantel-Haenszel||TCZ + PBO minus TCZ + MTX|Week 52: Analysis of association between treatment group and response, stratified by the randomization stratification factors: DAS28 remission status at Week 24 (\<2.6, \>=2.6 to \<=3.2), baseline weight-by-dosing group (\<80 kg q2w, \<80 kg qw, 80-\<100 kg q2w, 80-\<100 kg qw, \>=100 kg qw), participant anti-TNF exposure (Yes/No).||5.4|-16.3|0.3665
72622181|NCT05135754|144774391|SUPERIORITY||Mean Difference (Final Values)|14.3|||<|0.001|TWO_SIDED|95.0|8.26|20.35|||Mixed Models Analysis|||||20.35|8.26|<0.001
72622182|NCT05135754|144774392|SUPERIORITY||Mean Difference (Final Values)|0.03||||0.075|TWO_SIDED||||||Mixed Models Analysis|||||||0.075
72622183|NCT05135754|144774393|SUPERIORITY||Mean Difference (Final Values)|4.68||||0.004|TWO_SIDED|95.0|1.55|7.81|||Mixed Models Analysis|||||7.81|1.55|0.004
72622184|NCT02757963|144774394|OTHER||Proportion|0.883|||||TWO_SIDED|95.0|0.849|0.912|||||Proportion = Numerator / Denominator. 95% confidence interval on the proportion is calculated by using the exact (Clopper-Pearson) method.|||0.912|0.849|
72371564|NCT00669409|144253439|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-18.5|STANDARD_ERROR_OF_MEAN|7.98|||TWO_SIDED|95.0|-34.3|-2.8||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-2.8|-34.3|
72432166|NCT04319094|144376814|SUPERIORITY||Median Difference (Net)|17.99|STANDARD_ERROR_OF_MEAN|6.14||0.0036|TWO_SIDED|95.0|5.92|30.06||The a priori threshold for statistical significance is p=0.05.|Mixed Models Analysis|Degrees of freedom: 366||Null hypothesis: there is no difference in the mean SF36-emotional functioning scores from baseline to 6-month for all study participants.|A series of generalized linear mixed-effect models were implemented to predict the outcome measurements. The primary fixed effect predictors were group (control vs. PEERS), time (categorical), and group \* time. Random terms in all models were: study participants and their interaction with time. The covariance of dependent variable values across time was modeled as a first-order auto-regression decaying function (AR1). Higher order fixed and random terms were pretested and removed from the model if nonsignificant.|30.06|5.92|0.0036
72432167|NCT04319094|144376814|SUPERIORITY||Median Difference (Net)|16.24|STANDARD_ERROR_OF_MEAN|5.98||0.007|TWO_SIDED|95.0|4.47|28.01||The a priori threshold for statistical significance is p=0.05.|Mixed Models Analysis|Degrees of freedom: 366||Null hypothesis: there is no difference in the mean SF36-emotional functioning scores from baseline to 9-month for all study participants.|A series of generalized linear mixed-effect models were implemented to predict the outcome measurements. The primary fixed effect predictors were group (control vs. PEERS), time (categorical), and group \* time. Random terms in all models were: study participants and their interaction with time. The covariance of dependent variable values across time was modeled as a first-order auto-regression decaying function (AR1). Higher order fixed and random terms were pretested and removed from the model if nonsignificant.|28.01|4.47|0.007
72432168|NCT04319094|144376814|SUPERIORITY||Mean Difference (Net)|12.26|STANDARD_ERROR_OF_MEAN|6.58||0.065|TWO_SIDED|95.0|-0.68|25.19||The a priori threshold for statistical significance is p=0.05.|Mixed Models Analysis|Degrees of freedom: 366||Null hypothesis: there is no difference in the mean SF36-emotional functioning scores from baseline to 12-month for all study participants.|A series of generalized linear mixed-effect models were implemented to predict the outcome measurements. The primary fixed effect predictors were group (control vs. PEERS), time (categorical), and group \* time. Random terms in all models were: study participants and their interaction with time. The covariance of dependent variable values across time was modeled as a first-order auto-regression decaying function (AR1). Higher order fixed and random terms were pretested and removed from the model if nonsignificant.|25.19|-0.68|0.065
72432169|NCT04319094|144376814|SUPERIORITY|||||||0.881|||||||Mixed Models Analysis|||Null hypothesis: There is no difference in the change of emotional functioning over time between the control and PEERS participants.||||0.8810
72432170|NCT04319094|144376815|SUPERIORITY|||||||0.031||||||The a priori threshold for statistical significance is p=0.05.|F-test for overall significance|Degrees of freedom: 370||Null hypothesis: there is no difference in the change in probability of ER use from baseline to post-intervention between PEERS and control participants.|A series of generalized linear mixed-effect models were implemented to predict the outcome measurements. The primary fixed effect predictors were group (control vs. PEERS), time (categorical), and group \* time. Random terms in all models were: study participants and their interaction with time. The covariance of dependent variable values across time was modeled as a first-order auto-regression decaying function (AR1). Higher order fixed and random terms were pretested and removed from the model if nonsignificant.|||0.031
72432171|NCT04319094|144376820|SUPERIORITY||Mean Difference (Net)|-4.98|STANDARD_ERROR_OF_MEAN|1.42||0.0005|TWO_SIDED|95.0|-7.78|-2.18||The a priori threshold for statistical significance is p=0.05.|Mixed Models Analysis|Degrees of freedom: 414|Score difference: post-intervention - baseline|Null hypothesis: there is no difference in the mean UCLA Loneliness scores from baseline to post-intervention for all study participants.|A series of generalized linear mixed-effect models were implemented to predict the outcome measurements. The primary fixed effect predictors were group (control vs. PEERS), time (categorical), and group \* time. Random terms in all models were: study participants and their interaction with time. The covariance of dependent variable values across time was modeled as a first-order auto-regression decaying function (AR1). Higher order fixed and random terms were pretested and removed from the model if nonsignificant.|-2.18|-7.78|0.0005
72432172|NCT04319094|144376820|SUPERIORITY||Mean Difference (Net)|-7.38|STANDARD_ERROR_OF_MEAN|1.88|<|0.0001|TWO_SIDED|95.0|-11.08|-3.69||The a priori threshold for statistical significance is p=0.05.|Mixed Models Analysis|Degrees of freedom: 414|Score difference: 3-month - baseline|Null hypothesis: there is no difference in the mean UCLA Loneliness scores from baseline to 3-month for all study participants.|A series of generalized linear mixed-effect models were implemented to predict the outcome measurements. The primary fixed effect predictors were group (control vs. PEERS), time (categorical), and group \* time. Random terms in all models were: study participants and their interaction with time. The covariance of dependent variable values across time was modeled as a first-order auto-regression decaying function (AR1). Higher order fixed and random terms were pretested and removed from the model if nonsignificant.|-3.69|-11.08|<0.0001
72432173|NCT04319094|144376820|SUPERIORITY||Mean Difference (Net)|-7.63|STANDARD_ERROR_OF_MEAN|1.87|<|0.0001|TWO_SIDED|95.0|-11.3|-3.95||The a priori threshold for statistical significance is p=0.05.|Mixed Models Analysis|Degrees of freedom: 414|Score difference: 6-month - baseline|Null hypothesis: there is no difference in the mean UCLA Loneliness scores from baseline to 6-month for all study participants.|A series of generalized linear mixed-effect models were implemented to predict the outcome measurements. The primary fixed effect predictors were group (control vs. PEERS), time (categorical), and group \* time. Random terms in all models were: study participants and their interaction with time. The covariance of dependent variable values across time was modeled as a first-order auto-regression decaying function (AR1). Higher order fixed and random terms were pretested and removed from the model if nonsignificant.|-3.95|-11.3|<0.0001
72616014|NCT04180696|144762656|SUPERIORITY||Hazard Ratio (HR)|1.25|STANDARD_ERROR_OF_MEAN|0.476||0.64|TWO_SIDED|95.0|0.492|3.175|||Regression, Cox|Adjusted for NYHA class and sex.||||3.175|0.492|0.64
72616015|NCT04180696|144762657|SUPERIORITY|||||||0.78|||||||Log Rank|||||||0.78
72371565|NCT00669409|144253439|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|3.2|STANDARD_ERROR_OF_MEAN|7.99|||TWO_SIDED|95.0|-12.6|19.0||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||19.0|-12.6|
72432174|NCT04319094|144376820|SUPERIORITY||Mean Difference (Net)|-8.12|STANDARD_ERROR_OF_MEAN|1.74|<|0.0001|TWO_SIDED|95.0|-11.53|-4.7||The a priori threshold for statistical significance is p=0.05.|Mixed Models Analysis|Degrees of freedom: 414|Score difference: 9-month - baseline|Null hypothesis: there is no difference in the mean UCLA Loneliness scores from baseline to 9-month for all study participants.|A series of generalized linear mixed-effect models were implemented to predict the outcome measurements. The primary fixed effect predictors were group (control vs. PEERS), time (categorical), and group \* time. Random terms in all models were: study participants and their interaction with time. The covariance of dependent variable values across time was modeled as a first-order auto-regression decaying function (AR1). Higher order fixed and random terms were pretested and removed from the model if nonsignificant.|-4.7|-11.53|<0.0001
72432175|NCT04319094|144376820|SUPERIORITY||Mean Difference (Net)|-8.26|STANDARD_ERROR_OF_MEAN|2.09|<|0.0001|TWO_SIDED|95.0|-12.37|-4.14||The a priori threshold for statistical significance is p=0.05.|Mixed Models Analysis|Degrees of freedom: 414|Score difference: 12-month - baseline|Null hypothesis: there is no difference in the mean UCLA Loneliness scores from baseline to 12-month for all study participants.|A series of generalized linear mixed-effect models were implemented to predict the outcome measurements. The primary fixed effect predictors were group (control vs. PEERS), time (categorical), and group \* time. Random terms in all models were: study participants and their interaction with time. The covariance of dependent variable values across time was modeled as a first-order auto-regression decaying function (AR1). Higher order fixed and random terms were pretested and removed from the model if nonsignificant.|-4.14|-12.37|<0.0001
72432176|NCT04319094|144376820|SUPERIORITY|||||||0.6857|||||||Mixed Models Analysis|||Null hypothesis: there is no statistical difference in the change of UCLA Loneliness score over time between control and PEERS participants||||0.6857
72616016|NCT04180696|144762658|SUPERIORITY||Hazard Ratio (HR)|1.02|STANDARD_ERROR_OF_MEAN|0.817||0.98|TWO_SIDED|95.0|0.206|5.056|||Regression, Cox|||||5.056|0.206|0.98
72616017|NCT00963508|144762663|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
72616018|NCT00963508|144762664|SUPERIORITY_OR_OTHER|||||||0.0005|||||||t-test, 2 sided|||||||0.0005
72616019|NCT04739709|144762669|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
72616020|NCT04739709|144762670|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
72616021|NCT04739709|144762672|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
72616022|NCT04739709|144762673|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
72616023|NCT04739709|144762674|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
72371566|NCT00669409|144253439|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-9.4|STANDARD_ERROR_OF_MEAN|7.88|||TWO_SIDED|95.0|-25.0|6.2||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||6.2|-25.0|
72616024|NCT04739709|144762675|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
72616025|NCT04739709|144762676|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
72616026|NCT04739709|144762677|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
72616027|NCT04739709|144762678|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
72616028|NCT04739709|144762679|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
72616029|NCT04739709|144762680|SUPERIORITY||Mean Difference (Net)|-1.6|||<|0.001|TWO_SIDED|95.0|-1.8|-1.3|||ANCOVA||Treatment Difference = APP13007-Placebo. Mean Difference Is the least-squares mean difference from the ANCOVA model with treatment as a fixed effect and baseline as a covariate.|||-1.3|-1.8|<0.001
72616030|NCT04739709|144762681|SUPERIORITY||Mean Difference (Net)|-0.7|||<|0.001|TWO_SIDED|95.0|-0.9|-0.6|||ANCOVA||Treatment Difference = APP13007-Placebo. Mean Difference Is the least-squares mean difference from the ANCOVA model with treatment as a fixed effect and baseline as a covariate.|||-0.6|-0.9|<0.001
72616031|NCT04739709|144762682|SUPERIORITY||Mean Difference (Net)|-0.7|||<|0.001|TWO_SIDED|95.0|-0.8|-0.5|||ANCOVA||Treatment Difference = APP13007-Placebo. Mean Difference Is the least-squares mean difference from the ANCOVA model with treatment as a fixed effect and baseline as a covariate.|||-0.5|-0.8|<0.001
72616032|NCT04739709|144762683|SUPERIORITY||Mean Difference (Net)|-0.03||||0.017|TWO_SIDED|95.0|-0.06|-0.01|||ANCOVA||Treatment Difference = APP13007-Placebo. Mean Difference Is the least-squares mean difference from the ANCOVA model with treatment as a fixed effect and baseline as a covariate.|||-0.01|-0.06|0.017
72616033|NCT04739709|144762684|SUPERIORITY||Mean Difference (Net)|-0.07|||<|0.001|TWO_SIDED|95.0|-0.1|-0.04|||ANCOVA||Treatment Difference = APP13007-Placebo. Mean Difference Is the least-squares mean difference from the ANCOVA model with treatment as a fixed effect and baseline as a covariate.|||-0.04|-0.10|<0.001
72616034|NCT04739709|144762685|SUPERIORITY||Mean Difference (Net)|-0.09|||<|0.001|TWO_SIDED|95.0|-0.11|-0.06|||ANCOVA||Treatment Difference = APP13007-Placebo. Mean Difference Is the least-squares mean difference from the ANCOVA model with treatment as a fixed effect and baseline as a covariate.|||-0.06|-0.11|<0.001
72616035|NCT04739709|144762686|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
72616036|NCT01181479|144762688|EQUIVALENCE|Comparison of AG200-15 and Lessina for cycles 1-6.||||||0.067|||||||Chi-squared|||||||0.067
72616037|NCT00433290|144762731|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Week 4 Change from Baseline. Treatment effects and interaction effects were evaluated based on two-sided significance level of 0.05. No adjustments for multiple comparisons were made.|Mixed Models Analysis|Repeated Measures Model: Change=Treatment,NSAID use, Pooled Investigator, Visit, Baseline, Treatment\*Visit, Baseline\*Visit||Null hypothesis=the difference in the BPI average pain score between the duloxetine and placebo treatment goups at the last visit of the treatment phase is zero.||||<0.001
72616038|NCT00433290|144762731|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Week 7 Change from Baseline. Treatment effects and interaction effects were evaluated based on two-sided significance level of 0.05. No adjustments for multiple comparisons were made.|Mixed Models Analysis|Repeated Measures Model: Change=Treatment,NSAID use, Pooled Investigator, Visit, Baseline, Treatment\*Visit, Baseline\*Visit||Null hypothesis=the difference in the BPI average pain score between the duloxetine and placebo treatment goups at the last visit of the treatment phase is zero.||||<0.001
72622185|NCT02757963|144774395|OTHER||Proportion|0.877|||||TWO_SIDED|95.0|0.846|0.904|||||Proportion = Numerator / Denominator. 95% confidence interval on the proportion is calculated by using the exact (Clopper-Pearson) method.|For Arm IPSS \>=8||0.904|0.846|
72432177|NCT04319094|144376821|SUPERIORITY||Mean Difference (Net)|1.79|STANDARD_ERROR_OF_MEAN|0.54||0.001|TWO_SIDED|95.0|0.72|2.86|||Mixed Models Analysis|Degrees of freedom: 421|Score difference: post-intervention - baseline|Null hypothesis: there is no difference in the mean GSES scores from baseline to post-intervention for all study participants.|A series of generalized linear mixed-effect models were implemented to predict the outcome measurements. The primary fixed effect predictors were group (control vs. PEERS), time (categorical), and group \* time. Random terms in all models were: study participants and their interaction with time. The covariance of dependent variable values across time was modeled as a first-order auto-regression decaying function (AR1). Higher order fixed and random terms were pretested and removed from the model if nonsignificant.|2.86|0.72|0.001
72554923|NCT03086460|144641764|SUPERIORITY||Mean Difference (Final Values)|0.111|||<|0.001|TWO_SIDED|95.0|0.05|0.171|||ANCOVA|||"Comparison groups were:~Treatment A (CHF 1531 pMDI 6 μg TDD) versus Treatment E (Placebo).~The primary endpoint was analyzed using an analysis of covariance (ANCOVA) including treatment, period, and patient as fixed effects and baseline as a covariate. The confidence intervals (CIs) and the p-values of the comparisons between each dose of CHF 1531 pMDI and Placebo at Day 14 were adjusted for multiplicity, based on the parametric simulation method of Edwards and Berry."||0.171|0.050|<0.001
72616039|NCT00433290|144762731|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Week 13 Change from Baseline. Treatment effects and interaction effects were evaluated based on two-sided significance level of 0.05. No adjustments for multiple comparisons were made.|Mixed Models Analysis|Repeated Measures Model: Change=Treatment,NSAID use, Pooled Investigator, Visit, Baseline, Treatment\*Visit, Baseline\*Visit||Null hypothesis=the difference in the BPI average pain score between the duloxetine and placebo treatment goups at the last visit of the treatment phase is zero.||||<0.001
72616040|NCT00433290|144762732|SUPERIORITY_OR_OTHER|||||||0.164||95.0|||||ANCOVA|Model: PGI-Improvement=Treatment, Pooled Investigator, baseline severity and NSAID used for main effect p-values.||||||0.164
72616041|NCT00433290|144762733|SUPERIORITY_OR_OTHER|||||||0.016||95.0||||P-value for Change from Baseline (change = endpoint - baseline)|ANCOVA|Model: Change=Treatment, Pooled Investigator, NSAID use and Baseline for main effects p-value.||||||0.016
72616042|NCT00433290|144762734|SUPERIORITY_OR_OTHER|||||||0.068||95.0||||P-value for Change from Baseline. Change = Week 13 value minus baseline value.|ANCOVA|Model: Change = Treatment, Pooled Investigator, NSAID use and Baseline for main effects p-value.||||||0.068
72616043|NCT00433290|144762735|SUPERIORITY_OR_OTHER|||||||0.064||95.0||||P-value for Change from Baseline. Change = Week 13 value minus baseline value.|ANCOVA|Model: Change = Treatment, Pooled Investigator, NSAID use and Baseline for main effects p-value.||||||0.064
72616044|NCT00433290|144762736|SUPERIORITY_OR_OTHER|||||||0.008||95.0||||P-value for Change in Weekly 24-Hour Average Pain. Change = endpoint minus baseline.|ANCOVA|Model: Change = Treatment, Pooled Investigator, NSAID use and Baseline for main effects p-value.||||||0.008
72616045|NCT00433290|144762736|SUPERIORITY_OR_OTHER|||||||0.047||95.0||||P-value for Change in Weekly 24-Hour Worst Pain. Change = Endpoint minus baseline.|ANCOVA|Model: Change = Treatment, Pooled Investigator, NSAID use and Baseline for main effects p-value.||||||0.047
72504421|NCT01855789|144539438|SUPERIORITY||Estimated Mean Difference|0.24|STANDARD_ERROR_OF_MEAN|0.22|||TWO_SIDED|95.0|-0.21|0.68|||||TCZ + PBO minus TCZ + MTX|ANCOVA model included Week 24 bone erosion as a covariate, treatment group, and the randomization stratification factors: DAS28 remission status at Week 24 (\<2.6, \>/=2.6 to \</=3.2), participant anti-TNF exposure (Yes/No), baseline weight-by-dosing group (\<80 kg q2w, 80-\<100 kg q2w, 80-\<100 kg qw, \>=100 kg qw).||0.68|-0.21|
72616046|NCT00433290|144762737|SUPERIORITY_OR_OTHER|||||||0.009||95.0|||||ANCOVA|Model: Change = Treatment, Pooled Investigator, NSAID use and Baseline for main effects p-value.||||||0.009
72616047|NCT00433290|144762738|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Fisher Exact|||||||<0.001
72616048|NCT00433290|144762739|SUPERIORITY_OR_OTHER|||||||0.897||95.0||||P-value for Mental Component Summary Change from Baseline. Change = Endpoint minus baseline.|ANCOVA|Model: Change = Treatment, Pooled Investigator, NSAID use and Baseline for main effects p-values.||||||0.897
72616049|NCT00433290|144762739|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Physical Component Summary Change from Baseline. Change = Endpoint minus baseline.|ANCOVA|Model: Change = Treatment, Pooled Investigator, NSAID use and Baseline for main effects p-values.||||||<0.001
72616050|NCT00433290|144762739|SUPERIORITY_OR_OTHER|||||||0.004||95.0||||P-value for Bodily Pain Change from Baseline. Change = Endpoint minus baseline.|ANCOVA|Model: Change = Treatment, Pooled Investigator, NSAID use and Baseline for main effects p-values.||||||0.004
72616051|NCT00433290|144762739|SUPERIORITY_OR_OTHER|||||||0.051||95.0||||P-value for General Health Change from Baseline. Change = Endpoint minus baseline.|ANCOVA|Model: Change = Treatment, Pooled Investigator, NSAID use and Baseline for main effects p-values.||||||0.051
72616052|NCT00433290|144762739|SUPERIORITY_OR_OTHER|||||||0.508||95.0||||P-value for Mental Health Change from Baseline. Change = Endpoint minus baseline.|ANCOVA|Model: Change = Treatment, Pooled Investigator, NSAID use and Baseline for main effects p-values.||||||0.508
72616053|NCT00433290|144762739|SUPERIORITY_OR_OTHER|||||||0.019||95.0||||P-value for Physical Functioning Change from Baseline. Change = Endpoint minus baseline.|ANCOVA|Model: Change = Treatment, Pooled Investigator, NSAID use and Baseline for main effects p-values.||||||0.019
72616054|NCT00433290|144762739|SUPERIORITY_OR_OTHER|||||||0.415||95.0||||P-value for Role-Emotional Change from Baseline. Change = Endpoint minus baseline.|ANCOVA|Model: Change = Treatment, Pooled Investigator, NSAID use and Baseline for main effects p-values.||||||0.415
72616055|NCT00433290|144762739|SUPERIORITY_OR_OTHER|||||||0.006||95.0||||P-value for Role-Physical Change from Baseline. Change = Endpoint minus baseline.|ANCOVA|Model: Change = Treatment, Pooled Investigator, NSAID use and Baseline for main effects p-values.||||||0.006
72504422|NCT03726671|144539454|OTHER|||||||0.0247|||||||Repeated measures ANOVA|||Betaine IER||||0.0247
72504423|NCT03726671|144539454|OTHER||||||<|0.0001|||||||Repeated measures ANOVA|||Choline IER||||<0.0001
72504424|NCT03726671|144539454|OTHER|||||||0.0002|||||||Repeated measures ANOVA|||Phosphatidylcholine IER||||0.0002
72504425|NCT03726671|144539455|OTHER||Odds Ratio (OR)|7.16|||<|0.001|TWO_SIDED|95.0|3.48|14.7|||Fisher Exact|||||14.7|3.48|<0.001
72504426|NCT03726671|144539455|OTHER||Odds Ratio (OR)|4.09||||0.01|TWO_SIDED|95.0|2.06|8.11|||Fisher Exact|||||8.11|2.06|0.01
72504427|NCT03726671|144539455|OTHER||Odds Ratio (OR)|1.75||||0.086|TWO_SIDED|95.0|0.86|3.58|||Fisher Exact|||||3.58|0.86|0.086
72504428|NCT03726671|144539456|OTHER|||||||0.6985|||||||t-test, 2 sided|||Betaine IER||||0.6985
72504429|NCT03726671|144539456|OTHER|||||||0.035|||||||t-test, 2 sided|||Choline IER||||0.0350
72616056|NCT00433290|144762739|SUPERIORITY_OR_OTHER|||||||0.342||95.0||||P-value for Social Functioning Change from Baseline. Change = Endpoint minus baseline.|ANCOVA|Model: Change = Treatment, Pooled Investigator, NSAID use and Baseline for main effects p-values.||||||0.342
72504430|NCT03726671|144539456|OTHER|||||||0.6864|||||||t-test, 2 sided|||Phosphatidylcholine IER||||0.6864
72616057|NCT00433290|144762739|SUPERIORITY_OR_OTHER|||||||0.135||95.0||||P-value for Vitality Change from Baseline. Change = Endpoint minus baseline.|ANCOVA|Model: Change = Treatment, Pooled Investigator, NSAID use and Baseline for main effects p-values.||||||0.135
72616058|NCT00433290|144762740|SUPERIORITY_OR_OTHER|||||||0.209||95.0||||P-value for EQ-5D Change from Baseline. Change = Endpoint minus baseline.|ANCOVA|Model: Change=Treament, Pooled Investigator, NSAID use and Baseline for main effect p-value.||||||0.209
72616059|NCT00433290|144762741|SUPERIORITY_OR_OTHER|||||||0.871||95.0||||P-value for Change from Baseline. Change = Week 13 value minus baseline.|ANCOVA|Model: Change = Treatment, Pooled Investigator, NSAID use and Baseline for main effects p-value.||||||0.871
72616060|NCT00433290|144762742|SUPERIORITY_OR_OTHER|||||||0.138||95.0||||P-value for Change from Baseline. Change = Endpoint minus baseline.|ANCOVA|Model: Change = Treatment, Pooled Investigator, NSAID use and Baseline for main effects p-value.||||||0.138
72616061|NCT00433290|144762743|SUPERIORITY_OR_OTHER|||||||0.003||95.0||||P-value for Change from Baseline. Change = Endpoint minus baseline.|ANCOVA|||||||0.003
72616062|NCT00433290|144762744|SUPERIORITY_OR_OTHER|||||||0.015||95.0||||P-value for Change from Baseline. Change = Endpoint minus baseline.|ANCOVA|||||||0.015
72616063|NCT00433290|144762745|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Change from Baseline. Change = Endpoint minus baseline.|ANCOVA|||||||<0.001
72616064|NCT00433290|144762745|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||P-value for direct analgesic effect. The null hypothesis was tested by testing a1=0 versus a1≠0.|Regression, Linear|||Path analysis was used to test null hypothesis that change in BPI average pain severity depends on improvement of BDI or HADS-A, versus improvement in BPI average pain severity is due to a direct analgesic effect of treatment and not dependent on improvement in depression or anxiety symptoms. Model:Change in BPI average pain score=a0+a1\*treatment group+a2\*change in BDI total+a3\*change in HADS-A+a4\*BL of BPI average pain+a5\*BL of BDI total+a6\*BL of HADS-A.||||0.002
72616065|NCT00433290|144762746|SUPERIORITY_OR_OTHER|||||||0.007||95.0||||P-value for Change from Baseline. Change=Endpoint minus baseline.|ANCOVA|||||||0.007
72616066|NCT00433290|144762747|SUPERIORITY_OR_OTHER|||||||0.05||95.0||||P-value for Change from Baseline. Change = Endpoint minus baseline.|ANCOVA|||||||0.050
72616067|NCT00433290|144762748|SUPERIORITY_OR_OTHER|||||||0.913||95.0||||P-value for Change from Baseline. Change = Endpoint minus baseline.|ANCOVA|||||||0.913
72616068|NCT00433290|144762749|SUPERIORITY_OR_OTHER|||||||0.066||95.0||||P-value for Change from Baseline. Change = Endpoint minus baseline.|ANCOVA|||||||0.066
72616069|NCT00433290|144762750|SUPERIORITY_OR_OTHER|||||||0.001||95.0||||P-value for Change from Baseline. Change = Endpoint minus baseline.|ANCOVA|||||||0.001
72432178|NCT04319094|144376821|SUPERIORITY||Mean Difference (Net)|0.93|STANDARD_ERROR_OF_MEAN|0.67||0.18|TWO_SIDED|95.0|-0.39|2.25||The a priori threshold for statistical significance is p=0.05.|Mixed Models Analysis|Degrees of freedom: 421|Score difference: 3-month - baseline|Null hypothesis: there is no difference in the mean GSES scores from baseline to 3-month for all study participants.|A series of generalized linear mixed-effect models were implemented to predict the outcome measurements. The primary fixed effect predictors were group (control vs. PEERS), time (categorical), and group \* time. Random terms in all models were: study participants and their interaction with time. The covariance of dependent variable values across time was modeled as a first-order auto-regression decaying function (AR1). Higher order fixed and random terms were pretested and removed from the model if nonsignificant.|2.25|-0.39|0.18
72432179|NCT04319094|144376821|SUPERIORITY||Mean Difference (Net)|1.11|STANDARD_ERROR_OF_MEAN|0.68||0.11|TWO_SIDED|95.0|-0.24|2.45||The a priori threshold for statistical significance is p=0.05.|Mixed Models Analysis|Degrees of freedom: 421|Score difference: 6-month - baseline|Null hypothesis: there is no difference in the mean GSES scores from baseline to 6-month for all study participants.|A series of generalized linear mixed-effect models were implemented to predict the outcome measurements. The primary fixed effect predictors were group (control vs. PEERS), time (categorical), and group \* time. Random terms in all models were: study participants and their interaction with time. The covariance of dependent variable values across time was modeled as a first-order auto-regression decaying function (AR1). Higher order fixed and random terms were pretested and removed from the model if nonsignificant.|2.45|-0.24|0.11
72432180|NCT04319094|144376821|SUPERIORITY||Mean Difference (Net)|2.26|STANDARD_ERROR_OF_MEAN|0.65||0.0006|TWO_SIDED|95.0|0.98|3.54||The a priori threshold for statistical significance is p=0.05.|Mixed Models Analysis|Degrees of freedom: 421|Score difference: 9-month - baseline|Null hypothesis: there is no difference in the mean GSES scores from baseline to 9-month for all study participants.|A series of generalized linear mixed-effect models were implemented to predict the outcome measurements. The primary fixed effect predictors were group (control vs. PEERS), time (categorical), and group \* time. Random terms in all models were: study participants and their interaction with time. The covariance of dependent variable values across time was modeled as a first-order auto-regression decaying function (AR1). Higher order fixed and random terms were pretested and removed from the model if nonsignificant.|3.54|0.98|0.0006
72432181|NCT04319094|144376821|SUPERIORITY||Mean Difference (Net)|2.48|STANDARD_ERROR_OF_MEAN|0.75||0.001|TWO_SIDED|95.0|1.01|3.95||The a priori threshold for statistical significance is p=0.05.|Mixed Models Analysis|Degrees of freedom: 421|Score difference: 12-month - baseline|Null hypothesis: there is no difference in the mean GSES scores from baseline to 12-month for all study participants.|A series of generalized linear mixed-effect models were implemented to predict the outcome measurements. The primary fixed effect predictors were group (control vs. PEERS), time (categorical), and group \* time. Random terms in all models were: study participants and their interaction with time. The covariance of dependent variable values across time was modeled as a first-order auto-regression decaying function (AR1). Higher order fixed and random terms were pretested and removed from the model if nonsignificant.|3.95|1.01|0.001
72432182|NCT04319094|144376821|SUPERIORITY|||||||0.1195|||||||Mixed Models Analysis|||Null hypothesis: There is no difference in the change of GSES scores over time between the control and PEERS participants.||||0.1195
72432183|NCT04319094|144376822|SUPERIORITY||Mean Difference (Net)|3.22|STANDARD_ERROR_OF_MEAN|0.77|<|0.0001|TWO_SIDED|95.0|1.71|4.73||The a priori threshold for statistical significance is p=0.05.|Mixed Models Analysis|Degrees of freedom: 361|Score difference: post-intervention - baseline|Null hypothesis: there is no difference in the mean Brief-COPE Adaptive Coping scores from baseline to post-intervention for all study participants.|A series of generalized linear mixed-effect models were implemented to predict the outcome measurements. The primary fixed effect predictors were group (control vs. PEERS), time (categorical), and group \* time. Random terms in all models were: study participants and their interaction with time. The covariance of dependent variable values across time was modeled as a first-order auto-regression decaying function (AR1). Higher order fixed and random terms were pretested and removed from the model if nonsignificant.|4.73|1.71|<0.0001
72504431|NCT03726671|144539457|EQUIVALENCE|There are linear combinations of metabolites that differentiate (non-equivalent) the 25% choline diet from the 100% choline diet.|||||<|0.049|||||||Paired 2-sided t-test||||Supervised OPLSDA was used to determine the variable importance to projections of metabolites/signals that differentiated the 25% and 100% choline diet arms.|||<0.049
72616070|NCT00433290|144762751|SUPERIORITY_OR_OTHER|||||||0.26||95.0||||P-value for Change from Baseline. Change = Endpoint minus baseline.|ANCOVA|||||||0.260
72616071|NCT00433290|144762752|SUPERIORITY_OR_OTHER|||||||0.489||95.0||||P-value for Change from Baseline. Change = Endpoint minus baseline.|ANCOVA|||||||0.489
72616072|NCT00433290|144762753|SUPERIORITY_OR_OTHER|||||||0.131||95.0||||P-value for Change from Baseline. Change = Endpoint minus baseline.|ANCOVA|||||||0.131
72616073|NCT00433290|144762754|SUPERIORITY_OR_OTHER|||||||0.082||95.0||||P-value for Change from Baseline. Change = Endpoint minus baseline.|ANCOVA|||||||0.082
72616074|NCT00433290|144762756|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Alkaline Phosphatase Change from Baseline. Change = Endpoint minus baseline.|ANOVA|||||||<0.001
72616075|NCT00433290|144762756|SUPERIORITY_OR_OTHER|||||||0.01||95.0||||P-value for AST Change from Baseline. Change = Endpoint minus baseline.|ANOVA|||||||0.010
72616076|NCT00433290|144762756|SUPERIORITY_OR_OTHER|||||||0.023||95.0||||P-value for GGT Change from Baseline. Change = Endpoint minus baseline.|ANOVA|||||||0.023
72616077|NCT00433290|144762757|SUPERIORITY_OR_OTHER|||||||0.042||95.0||||P-value for Change from Baseline. Change = Endpoint minus baseline.|ANOVA|||||||0.042
72616078|NCT00433290|144762758|SUPERIORITY_OR_OTHER|||||||0.005||95.0||||P-value for Change from Baseline. Change = Endpoint minus baseline.|ANOVA|||||||0.005
72616079|NCT00433290|144762759|SUPERIORITY_OR_OTHER|||||||0.285||95.0||||P-value for SBP Change from Baseline. Change = Endpoint minus baseline.|ANOVA|||||||0.285
72616080|NCT00433290|144762759|SUPERIORITY_OR_OTHER|||||||0.668||95.0||||P-value for DBP Change from Baseline. Change = Endpoint minus baseline.|ANOVA|||||||0.668
72616081|NCT00433290|144762760|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Change from Baseline. Change = Endpoint minus baseline.|ANOVA|||||||<0.001
72371567|NCT00669409|144253439|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-4.6|STANDARD_ERROR_OF_MEAN|10.48|||TWO_SIDED|95.0|-25.4|16.1||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||16.1|-25.4|
72371568|NCT00669409|144253440|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-2.3|STANDARD_ERROR_OF_MEAN|7.98|||TWO_SIDED|95.0|-18.1|13.5||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||13.5|-18.1|
72504432|NCT03726671|144539458|OTHER|||||||0.9567|||||||Mixed Models Analysis|The model evaluates effects from SNP, diet and SNP x diet interaction. Due to crossover design, period and sequence effects were adjusted in the model||Diet x SNP interaction effect on Betaine IER in Pre-Menopausal Females||||0.9567
72504433|NCT03726671|144539458|OTHER|||||||0.0899|||||||Mixed Models Analysis|The model evaluates effects from SNP, diet and SNP x diet interaction. Due to crossover design, period and sequence effects were adjusted in the model||Diet x SNP interaction effect on Betaine IER in Post-Menopausal Females||||0.0899
72616082|NCT00433290|144762761|SUPERIORITY_OR_OTHER|||||||0.04||95.0|||||t-test, 2 sided|||||||0.040
72616083|NCT03837938|144762769|NON_INFERIORITY|According to the protocol and SAP non-inferiority margin was defined as 20%.|Difference in rates Levopront®-Libexin®|5.81|||||ONE_SIDED|97.5|-7.17|||||||Difference in daytime resolved rates Levopront® (Test) vs Libexin® (Control) was reported|||-7.17|
72616084|NCT03837938|144762770|NON_INFERIORITY|According to the protocol and SAP non-inferiority margin was defined as 20%|difference in rates Levopront®-Libexin®|5.43|||||ONE_SIDED|97.5|-7.31|||||||Difference in daytime resolved rates Levopront® (Test) vs Libexin® (Control) was reported|||-7.31|
72616085|NCT03837938|144762771|NON_INFERIORITY|non-inferiority margin was defined as 20%|||||>|0.999|||||||Fisher Exact|||||||>0.999
72616086|NCT03837938|144762772|NON_INFERIORITY|non-inferiority margin was defined as 20%|||||=|0.861|||||||Fisher Exact|||||||=0.861
72616087|NCT03837938|144762773|NON_INFERIORITY|non-inferiority margin was defined as 20%|||||<|0.001|||||||t-test, 1 sided|Between groups change was tested using two sample t-test (normal data) or Mann-Whitney test (violation of normality).||Daytime at Visit 2, Day 4||||<0.001
72616088|NCT03837938|144762773|NON_INFERIORITY|non-inferiority margin was defined as 20%|||||<|0.001|||||||t-test, 2 sided|Between groups change was tested using two sample t-test (normal data) or Mann-Whitney test (violation of normality).||Daytime at Visit 3, Day 8||||<0.001
72616089|NCT03837938|144762773|NON_INFERIORITY|non-inferiority margin was defined as 20%|||||<|0.001|||||||t-test, 1 sided|Between groups change was tested using two sample t-test (normal data) or Mann-Whitney test (violation of normality).||Nightime at Visit 2, Day 4||||<0.001
72616090|NCT03837938|144762773|NON_INFERIORITY|non-inferiority margin was defined as 20%|||||<|0.001|||||||t-test, 1 sided|Between groups change was tested using two sample t-test (normal data) or Mann-Whitney test (violation of normality).||Nighttime at Visit 3, Day 8||||<0.001
72616091|NCT03837938|144762774|NON_INFERIORITY|non-inferiority margin was defined as 20%|||||<|0.001|||||||t-test, 1 sided|Between groups change was tested using two sample t-test (normal data) or Mann-Whitney test (violation of normality).||Visit 2, Day 4||||<0.001
72616092|NCT03837938|144762774|NON_INFERIORITY|non-inferiority margin was defined as 20%|||||<|0.001|||||||t-test, 1 sided|Between groups change was tested using two sample t-test (normal data) or Mann-Whitney test (violation of normality).||at Visit 3, Day 8||||<0.001
72616093|NCT03837938|144762775|NON_INFERIORITY|non-inferiority margin is defined as 20%|||||=|0.336|||||||t-test, 1 sided|Between groups change was tested using two sample t-test (normal data) or Mann-Whitney test (violation of normality).||||||=0.336
72616094|NCT01917773|144762779|NON_INFERIORITY_OR_EQUIVALENCE|"Reported MIs and SDs in healthy volunteers from an adult study were used to calculate sample size (1). A sample size of 13 patients was deemed adequate to detect a 25% change in MI with 80% power.~Reference: Rao SS, Kavelock R, Beaty J, Ackerson K, et al. Effects of fat and carbohydrate meals on colonic motor response. Gut. Feb 2000;46(2):205-211."||||||0.087|TWO_SIDED||||||Wilcoxon signed rank test|||The Wilcoxon signed rank test was used to analyze change in MI at 15 minutes. Values were considered to be significant if P \<0.05.||||0.087
72616095|NCT01917773|144762779|SUPERIORITY_OR_OTHER|||||||0.552|TWO_SIDED||||||Wilcoxon signed rank test|||The Wilcoxon signed rank test was used to analyze change in MI at 30 minutes. Values were considered to be significant if P \<0.05.||||0.552
72616096|NCT01917773|144762779|SUPERIORITY_OR_OTHER|||||||0.807|TWO_SIDED||||||Wilcoxon signed rank test|||The Wilcoxon signed rank test was used to analyze change in MI at 45 minutes. Values were considered to be significant if P \<0.05.||||0.807
72616097|NCT00504309|144762791|SUPERIORITY_OR_OTHER|||||||0.002|||||||Mixed Models Analysis|Tukey p-values were used for post hoc comparisons.||Fasting triglycerides (mg/dL) were measured on two consecutive days and averaged for analysis at the end of each treatment period. The null hypothesis was that triglycerides did not differ between groups.||||0.002
72616098|NCT00504309|144762791|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Mixed Models Analysis|||Cholesterol values were compared as the average of two fasting values at the end of each treatment. Cholesterol values included LDL-C, HDL-C, total cholesterol, and calculated ratios.||||> 0.05
72616099|NCT03345095|144762804|SUPERIORITY||Mean Difference (Net)|-6.4||||0.0004|TWO_SIDED|95.0|-8.6|-2.5|||Wilcoxon (Mann-Whitney)|||||-2.5|-8.6|0.0004
72616100|NCT03345095|144762805|SUPERIORITY||Mean Difference (Net)|-0.55||||0.15|TWO_SIDED|95.0|-1.27|0.16|||Wilcoxon (Mann-Whitney)|||||0.16|-1.27|0.15
72616101|NCT01121575|144762836|SUPERIORITY_OR_OTHER||Ratio of adjust geometric mean|69.25|||||TWO_SIDED|90.0|54.22|88.44|||||Ratio of crizotinib + dacomitinib / crizotinib alone adjust geometric mean was analyzed using the mixed effect model and displayed as percentage.|Statistical analysis was performed for crizotinib AUClast for participants who had both Day -1 and C2D1 data. Result for the analysis of AUClast was based on data from 11 participants. No statistical analysis was performed for PF-06260182.||88.44|54.22|
72622186|NCT02757963|144774395|OTHER||Proportion|0.889|||||TWO_SIDED|95.0|0.854|0.917|||||Proportion = Numerator / Denominator. 95% confidence interval on the proportion is calculated by using the exact (Clopper-Pearson) method.|For Arm IPSS \>=8 and BPE/BPO \>=3||0.917|0.854|
72622187|NCT02757963|144774395|OTHER||Proportion|0.873|||||TWO_SIDED|95.0|0.843|0.9|||||Proportion = Numerator / Denominator. 95% confidence interval on the proportion is calculated by using the exact (Clopper-Pearson) method.|For Arm IPSS \>=8 or BPE/BPO \>=3||0.900|0.843|
72622188|NCT02757963|144774396|OTHER||Proportion|0.9|||||TWO_SIDED|95.0|0.87|0.926|||||Proportion = Numerator / Denominator. 95% confidence interval on the proportion is calculated by using the exact (Clopper-Pearson) method.|For Arm IPSS \>=8||0.926|0.870|
72616102|NCT01121575|144762837|SUPERIORITY_OR_OTHER||Ratio of adjust geometric mean|78.84|||||TWO_SIDED|90.0|58.9|105.54|||||Ratio of crizotinib + dacomitinib / crizotinib alone adjust geometric mean was analyzed using the mixed effect model and displayed as percentage.|Statistical analysis was performed for crizotinib AUC10 for participants who had both Day -1 and C2D1 data. Result for the analysis of AUC10 was based on data from 6 participants. No statistical analysis was performed for PF-06260182.||105.54|58.90|
72622189|NCT02757963|144774396|OTHER||Proportion|0.907|||||TWO_SIDED|95.0|0.873|0.934|||||Proportion = Numerator / Denominator. 95% confidence interval on the proportion is calculated by using the exact (Clopper-Pearson) method.|For Arm BPE/BPO \>=3||0.934|0.873|
72622190|NCT02757963|144774396|OTHER||Proportion|0.907|||||TWO_SIDED|95.0|0.873|0.935|||||Proportion = Numerator / Denominator. 95% confidence interval on the proportion is calculated by using the exact (Clopper-Pearson) method.|For Arm IPSS \>=8 and BPE/BPO \>=3||0.935|0.873|
72622191|NCT02757963|144774396|OTHER||Proportion|0.9|||||TWO_SIDED|95.0|0.87|0.925|||||Proportion = Numerator / Denominator. 95% confidence interval on the proportion is calculated by using the exact (Clopper-Pearson) method.|For Arm PSS \>=8 or BPE/BPO \>=3||0.925|0.870|
72622192|NCT02757963|144774397|OTHER||Proportion|0.362|||||TWO_SIDED|95.0|0.337|0.386|||||Proportion = Numerator / Denominator. 95% confidence interval on the proportion is calculated by using the exact (Clopper-Pearson) method.|For Arm IPSS \>=8||0.386|0.337|
72622193|NCT02757963|144774397|OTHER||Proportion|0.368|||||TWO_SIDED|95.0|0.341|0.395|||||Proportion = Numerator / Denominator. 95% confidence interval on the proportion is calculated by using the exact (Clopper-Pearson) method.|For Arm BPE/BPO \>=3||0.395|0.341|
72622194|NCT02757963|144774397|OTHER||Proportion|0.377|||||TWO_SIDED|95.0|0.349|0.406|||||Proportion = Numerator / Denominator. 95% confidence interval on the proportion is calculated by using the exact (Clopper-Pearson) method.|For Arm IPSS \>=8 and BPE/BPO \>=3||0.406|0.349|
72622195|NCT02757963|144774397|OTHER||Proportion|0.355|||||TWO_SIDED|95.0|0.332|0.379|||||Proportion = Numerator / Denominator. 95% confidence interval on the proportion is calculated by using the exact (Clopper-Pearson) method.|For Arm IPSS \>=8 or BPE/BPO \>=3||0.379|0.332|
72622196|NCT02757963|144774398|OTHER||Kappa statistic|0.55|||||TWO_SIDED|95.0|0.51|0.58||||||||0.58|0.51|
72622197|NCT03109769|144774419|SUPERIORITY|||||||0.0444|||||||Wilcoxon (Mann-Whitney)|||"The sample size was calculated as 44 participants. Sample size calculation was carried out through a pilot study on 30 participants with the group I mean=1.31, SD=0.39 and group II mean=1.62, SD=0.30, with ⍺=0.05 and 80% power.~The null hypothesis was: there is no difference in plaque index and gingival index between verbal oral hygiene instructions and oral hygiene instructions using mobile applications in patients with orthodontic fixed appliances."||||0.0444
72622198|NCT03109769|144774419|SUPERIORITY||Mean Difference (Net)|-0.1373||||0.0002|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||"Difference in plaque index within the first group (mobile phone application) at 4 weeks compared to baseline.~The mean difference was calculated as follows:~plaque index at 4 weeks - plaque index at baseline"|||||0.0002
72622199|NCT03109769|144774419|SUPERIORITY||Median Difference (Final Values)|0.0932||||0.0283|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||"Difference in plaque index within the second group (verbal oral hygiene instructions) at 4 weeks compared to baseline.~The mean difference was calculated as follows:~plaque index at 4 weeks - plaque index at baseline"|||||0.0283
72622200|NCT03109769|144774420|SUPERIORITY|||||||0.0283|||||||Wilcoxon (Mann-Whitney)|||"The sample size was calculated as 44 participants. Sample size calculation was carried out through a pilot study on 30 participants with the group I mean=1.31, SD=0.39 and group II mean=1.62, SD=0.30, with ⍺=0.05 and 80% power.~The null hypothesis was: there is no difference in plaque index and gingival index between verbal oral hygiene instructions and oral hygiene instructions using mobile applications in patients with orthodontic fixed appliances."||||0.0283
72622201|NCT03109769|144774420|SUPERIORITY||Mean Difference (Net)|-0.1177||||0.0002|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||"Difference in gingival index within the first group (mobile phone application) at 4 weeks compared to baseline.~The mean difference was calculated as follows:~gingival index at 4 weeks - gingival index at baseline"|||||0.0002
72622202|NCT03109769|144774420|SUPERIORITY||Mean Difference (Net)|0.1014||||0.4809|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||"Difference in gingival index within the second group (verbal oral hygiene instructions) at 4 weeks compared to baseline.~The mean difference was calculated as follows:~gingival index at 4 weeks - gingival index at baseline"|||||0.4809
72622203|NCT02410200|144774430|SUPERIORITY_OR_OTHER|||||||0.009|||||||Wilcoxon Signed Rank test|||||||0.0090
72622204|NCT04250207|144774530|SUPERIORITY|||||||0.0065|||||||Other (Wilcoxon Rank Sum Test)|||||||0.0065
72622205|NCT04250207|144774530|SUPERIORITY|||||||0.0344|||||||Other (Wilcoxon Rank Sum Test)|||||||0.0344
72622206|NCT04250207|144774531|SUPERIORITY|||||||0.3587|||||||Wilcoxon Rank Sum Test|||Baseline||||0.3587
72622207|NCT04250207|144774531|SUPERIORITY|||||||0.5724|||||||Wilcoxon Rank Sum Test|||Baseline||||0.5724
72622208|NCT04250207|144774531|SUPERIORITY|||||||0.3703|||||||Wilcoxon Rank Sum Test|||Week 1||||0.3703
72622209|NCT04250207|144774531|SUPERIORITY||||||>|0.9999|||||||Wilcoxon Rank Sum Test|||Week 1||||> 0.9999
72622210|NCT04250207|144774531|SUPERIORITY|||||||0.3703|||||||Wilcoxon Rank Sum Test|||Week 2||||0.3703
72622211|NCT04250207|144774531|SUPERIORITY||||||>|0.9999|||||||Wilcoxon Rank Sum Test|||Week 2||||> 0.9999
72622212|NCT04250207|144774531|SUPERIORITY|||||||0.0257|||||||Wilcoxon Rank Sum Test|||Week 3||||0.0257
72622213|NCT04250207|144774531|SUPERIORITY|||||||0.7263|||||||Wilcoxon Rank Sum Test|||||||0.7263
72622214|NCT04250207|144774531|SUPERIORITY|||||||0.0607|||||||Wilcoxon Rank Sum Test|||Week 5||||0.0607
72622215|NCT04250207|144774531|SUPERIORITY|||||||0.046|||||||Wilcoxon Rank Sum Test|||Week 5||||0.0460
72622216|NCT04250207|144774531|SUPERIORITY|||||||0.0111|||||||Wilcoxon Rank Sum Test|||Week 7||||0.0111
72622217|NCT04250207|144774531|SUPERIORITY|||||||0.0011|||||||Wilcoxon Rank Sum Test|||Week 7||||0.0011
72622218|NCT04250207|144774531|SUPERIORITY|||||||0.02|||||||Wilcoxon Rank Sum Test|||Week 9||||0.0200
72622219|NCT04250207|144774531|SUPERIORITY|||||||0.0476|||||||Wilcoxon Rank Sum Test|||Week 9||||0.0476
72622220|NCT04250207|144774531|SUPERIORITY|||||||0.0065|||||||Wilcoxon Rank Sum Test|||Week 12||||0.0065
72622221|NCT04250207|144774531|SUPERIORITY|||||||0.0344|||||||Wilcoxon Rank Sum Test|||Week 12||||0.0344
72622222|NCT04250207|144774531|SUPERIORITY|||||||0.025|||||||Wilcoxon Rank Sum Test|||Week 16||||0.0250
72622223|NCT04250207|144774531|SUPERIORITY|||||||0.0733|||||||Wilcoxon Rank Sum Test|||Week 16||||0.0733
72622224|NCT04250207|144774531|SUPERIORITY|||||||0.0072|||||||Wilcoxon Rank Sum Test|||Week 20||||0.0072
72622225|NCT04250207|144774531|SUPERIORITY|||||||0.1124|||||||Wilcoxon Rank Sum Test|||Week 20||||0.1124
72622226|NCT04250207|144774531|SUPERIORITY|||||||0.0199|||||||Wilcoxon Rank Sum Test|||Week 24||||0.0199
72622227|NCT04250207|144774531|SUPERIORITY|||||||0.2331|||||||Wilcoxon Rank Sum Test|||Week 24||||0.2331
72622228|NCT04250207|144774531|SUPERIORITY|||||||0.0024|||||||Wilcoxon Rank Sum Test|||Week 38||||0.0024
72622229|NCT04250207|144774531|SUPERIORITY|||||||0.1672|||||||Wilcoxon Rank Sum Test|||Week 38||||0.1672
72622230|NCT04250207|144774531|SUPERIORITY|||||||0.0047|||||||Wilcoxon Rank Sum Test|||Week 52||||0.0047
72622231|NCT04250207|144774531|SUPERIORITY|||||||0.0625|||||||Wilcoxon Rank Sum Test|||Week 52||||0.0625
72622232|NCT04250207|144774532|SUPERIORITY|||||||0.2434|||||||Wilcoxon Rank Sum Test|||Week 1||||0.2434
72622233|NCT04250207|144774532|SUPERIORITY|||||||0.2126|||||||Wilcoxon Rank Sum Test|||Week 1||||0.2126
72622234|NCT04250207|144774532|SUPERIORITY|||||||0.079|||||||Wilcoxon Rank Sum Test|||Week 2||||0.0790
72622235|NCT04250207|144774532|SUPERIORITY|||||||0.3043|||||||Wilcoxon Rank Sum Test|||Week 2||||0.3043
72622236|NCT04250207|144774532|SUPERIORITY|||||||0.0357|||||||Wilcoxon Rank Sum Test|||Week 3||||0.0357
72622237|NCT04250207|144774532|SUPERIORITY|||||||0.0803|||||||Wilcoxon Rank Sum Test|||Week 3||||0.0803
72622238|NCT04250207|144774532|SUPERIORITY|||||||0.015|||||||Wilcoxon Rank Sum Test|||Week 5||||0.0150
72622239|NCT04250207|144774532|SUPERIORITY|||||||0.0012|||||||Wilcoxon Rank Sum Test|||Week 5||||0.0012
72622240|NCT04250207|144774532|SUPERIORITY|||||||0.0314|||||||Wilcoxon Rank Sum Test|||Week 7||||0.0314
72622241|NCT04250207|144774532|SUPERIORITY|||||||0.0019|||||||Wilcoxon Rank Sum Test|||Week 7||||0.0019
72622242|NCT04250207|144774532|SUPERIORITY|||||||0.017|||||||Wilcoxon Rank Sum Test|||Week 9||||0.0170
72622243|NCT04250207|144774532|SUPERIORITY|||||||0.0021|||||||Wilcoxon Rank Sum Test|||Week 9||||0.0021
72622244|NCT04250207|144774532|SUPERIORITY|||||||0.0127|||||||Wilcoxon Rank Sum Test|||Week 12||||0.0127
72622245|NCT04250207|144774532|SUPERIORITY|||||||0.0014|||||||Wilcoxon Rank Sum Test|||Week 12||||0.0014
72622246|NCT04250207|144774532|SUPERIORITY|||||||0.0677|||||||Wilcoxon Rank Sum Test|||Week 16||||0.0677
72622247|NCT04250207|144774532|SUPERIORITY|||||||0.0243|||||||Wilcoxon Rank Sum Test|||Week 16||||0.0243
72622248|NCT04250207|144774532|SUPERIORITY|||||||0.1867|||||||Wilcoxon Rank Sum Test|||Week 20||||0.1867
72622249|NCT04250207|144774532|SUPERIORITY|||||||0.025|||||||Wilcoxon Rank Sum Test|||Week 20||||0.0250
72622250|NCT04250207|144774532|SUPERIORITY|||||||0.3213|||||||Wilcoxon Rank Sum Test|||Week 24||||0.3213
72622251|NCT04250207|144774532|SUPERIORITY|||||||0.0298|||||||Wilcoxon Rank Sum Test|||Week 24||||0.0298
72622252|NCT04250207|144774532|SUPERIORITY|||||||0.1449|||||||Wilcoxon Rank Sum Test|||Week 38||||0.1449
72622253|NCT04250207|144774532|SUPERIORITY|||||||0.0947|||||||Wilcoxon Rank Sum Test|||Week 38||||0.0947
72622254|NCT04250207|144774532|SUPERIORITY|||||||0.5181|||||||Wilcoxon Rank Sum Test|||Week 52||||0.5181
72622255|NCT04250207|144774532|SUPERIORITY|||||||0.1898|||||||Wilcoxon Rank Sum Test|||Week 52||||0.1898
72622256|NCT04250207|144774533|SUPERIORITY|||||||0.0021|||||||Log Rank|||||||0.0021
72622257|NCT04250207|144774533|SUPERIORITY|||||||0.1696|||||||Log Rank|||||||0.1696
72622258|NCT04250207|144774534|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.||||||0.4872|||||||Chi-square or Fisher exact|||Week 5||||0.4872
72622259|NCT04250207|144774534|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.||||||0.4634|||||||Chi-square or Fisher exact|||Week 5||||0.4634
72622260|NCT04250207|144774534|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.||||||0.605|||||||Chi-square or Fisher exact|||Week 7||||0.6050
72622261|NCT04250207|144774534|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.||||||0.4762|||||||Chi-square or Fisher exact|||Week 7||||0.4762
72622262|NCT04250207|144774534|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.|||||>|0.9999|||||||Chi-square or Fisher exact|||Week 9||||> 0.9999
72622263|NCT04250207|144774534|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.|||||>|0.9999|||||||Chi-square or Fisher exact|||Week 9||||> 0.9999
72622264|NCT04250207|144774534|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.||||||0.4227|||||||Chi-square or Fisher exact|||Week 12||||0.4227
72622265|NCT04250207|144774534|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.||||||0.6796|||||||Chi-square or Fisher exact|||Week 12||||0.6796
72504434|NCT03726671|144539458|OTHER|||||||0.9003|||||||Mixed Models Analysis|The model evaluates effects from SNP, diet and SNP x diet interaction. Due to crossover design, period and sequence effects were adjusted in the model||Diet x SNP interaction effect on Betaine IER in Males||||0.9003
72504435|NCT03726671|144539458|OTHER|||||||0.9932|||||||Mixed Models Analysis|The model evaluates effects from SNP, diet and SNP x diet interaction. Due to crossover design, period and sequence effects were adjusted in the model||Diet x SNP interaction effect on Choline IER in Pre-Menopausal Females||||0.9932
72616103|NCT01121575|144762839|SUPERIORITY_OR_OTHER||Ration of adjust geometric mean|70.6|||||TWO_SIDED|90.0|54.71|91.12|||||Ratio of crizotinib + dacomitinib / crizotinib alone adjust geometric mean was analyzed using the mixed effect model and displayed as percentage.|Statistical analysis was performed for crizotinib Cmax for participants who had both Day -1 and C2D1 data. Result for the analysis of Cmax was based on data from 11 participants. No statistical analysis was performed for PF-06260182.||91.12|54.71|
72616104|NCT01121575|144762842|SUPERIORITY_OR_OTHER||Ratio of adjust geometric mean|117.81|||||TWO_SIDED|90.0|64.97|213.61|||||Ratio of crizotinib + dacomitinib / dacomitinib alone adjust geometric mean was analyzed using the mixed effect model and displayed as percentage.|Statistical analysis was performed for dacomitinib AUClast for participants who had both Day -1 and C2D1 data. Result for the analysis of AUClast was based on data from 3 participants. No statistical analysis was performed for PF-05199265.||213.61|64.97|
72616105|NCT01121575|144762843|SUPERIORITY_OR_OTHER||Ratio of adjust geometric mean|121.9|||||TWO_SIDED|90.0|70.2|211.66|||||Ratio of crizotinib + dacomitinib / dacomitinib alone adjust geometric mean was analyzed using the mixed effect model and displayed as percentage.|Statistical analysis was performed for dacomitinib AUC24 for participants who had both Day -1 and C2D1 data. Result for the analysis of AUC24 was based on data from 3 participants. No statistical analysis was performed for PF-05199265.||211.66|70.20|
72616106|NCT01121575|144762845|SUPERIORITY_OR_OTHER||Ratio of adjust geometric mean|130.57|||||TWO_SIDED|90.0|82.46|206.73|||||Ratio of crizotinib + dacomitinib / dacomitinib alone adjust geometric mean was analyzed using the mixed effect model and displayed as percentage.|Statistical analysis was performed for dacomitinib Cmax for participants who had both Day -1 and C2D1 data. Result for the analysis of Cmax was based on data from 3 participants. No statistical analysis was performed for PF-05199265.||206.73|82.46|
72616107|NCT00724503|144762853|SUPERIORITY||Hazard Ratio (HR)|0.93||||0.551|TWO_SIDED|95.0|0.77|1.12|||Log Rank|||The null hypothesis tested for the primary efficacy endpoint is rate of progression (months) of SIRT/FOLFOX treatment versus FOLFOX is equal for both groups. The two-sided alternative hypothesis tested with 95% confidence is PFS rate for SIRT/FOLFOX treatment lower to that of FOLFOX.||1.12|0.77|0.551
72616108|NCT00724503|144762854|SUPERIORITY||Hazard Ratio (HR)|0.75|||<|0.05|TWO_SIDED|95.0|||||Log Rank|||A sample size of at least 450 patients for the SIRFLOX study was estimated to be needed to detect an increase in the median PFS at any site from 9.4 months to 12.5 months with 80% power and 95% confidence. Taking into account the number of patients who might receive the alternative treatment or lack of imaging data, the sample size was increased to 530. The Null hypothesis is no difference between the treatment arms with respect to PFS.||||< 0.05
72616109|NCT01186419|144762857|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0765|TWO_SIDED||||||t-test, 2 sided|||||||0.0765
72616110|NCT01022580|144762878|SUPERIORITY_OR_OTHER_LEGACY|||||||0.89|TWO_SIDED||||||unadj GEE|||||||0.89
72616111|NCT01022580|144762879|SUPERIORITY_OR_OTHER_LEGACY|||||||0.33|TWO_SIDED||||||unadj GEE|||||||0.33
72616112|NCT01500096|144762885|SUPERIORITY|||||||0.15|||||||Wilcoxon (Mann-Whitney)|2 sided Wilcoxon (Mann-Whitney)||Testing whether the changes from baseline to week 4 are significantly different between arms.||||0.15
72616113|NCT01500096|144762885|SUPERIORITY|||||||0.73|||||||Wilcoxon (Mann-Whitney)|2 sided Wilcoxon (Mann-Whitney)||Testing whether the changes from baseline to week 4 are significantly different between arms||||0.73
72616114|NCT01500096|144762886|SUPERIORITY|||||||0.1329|||||||Wilcoxon (Mann-Whitney)|2 sided Wilcoxon (Mann-Whitney)||Testing whether the changes from baseline to week 4 are significantly different between arms.||||0.1329
72616115|NCT01500096|144762886|SUPERIORITY|||||||0.1191|||||||Wilcoxon (Mann-Whitney)|2 sided Wilcoxon (Mann-Whitney)||Testing whether the changes from baseline to week 4 are significantly different between arms.||||0.1191
72616116|NCT01500096|144762887|SUPERIORITY|||||||0.7454|||||||Wilcoxon (Mann-Whitney)|2 sided Wilcoxon (Mann-Whitney)||Testing whether the changes from baseline to week 4 are significantly different between arms.||||0.7454
72616117|NCT01500096|144762887|SUPERIORITY|||||||0.7391|||||||Wilcoxon (Mann-Whitney)|2 sided Wilcoxon (Mann-Whitney)||Testing whether the changes from baseline to week 4 are significantly different between arms.||||0.7391
72616118|NCT01500096|144762888|SUPERIORITY|||||||0.6818|||||||Wilcoxon (Mann-Whitney)|2 sided Wilcoxon (Mann-Whitney)||Testing whether the changes from baseline to week 4 are significantly different between arms.||||0.6818
72616119|NCT01500096|144762888|SUPERIORITY|||||||0.0579|||||||Wilcoxon (Mann-Whitney)|2 sided Wilcoxon (Mann-Whitney)||Testing whether the changes from baseline to week 4 are significantly different between arms.||||0.0579
72616120|NCT01500096|144762889|SUPERIORITY|||||||0.17|||||||Wilcoxon (Mann-Whitney)|2 sided Wilcoxon (Mann-Whitney)||Testing whether the changes from baseline to week 4 are significantly different between arms.||||0.17
72616121|NCT01500096|144762889|SUPERIORITY|||||||0.51|||||||Wilcoxon (Mann-Whitney)|2 sided Wilcoxon (Mann-Whitney)||Testing whether the changes from baseline to week 4 are significantly different between arms.||||0.51
72616122|NCT01500096|144762890|SUPERIORITY|||||||0.7884|||||||Wilcoxon (Mann-Whitney)|2 sided Wilcoxon (Mann-Whitney)||Testing whether the changes from baseline to week 4 are significantly different between arms.||||0.7884
72616123|NCT01500096|144762890|SUPERIORITY|||||||0.5532|||||||Wilcoxon (Mann-Whitney)|2 sided Wilcoxon (Mann-Whitney)||Testing whether the changes from baseline to week 4 are significantly different between arms.||||0.5532
72616124|NCT01500096|144762891|SUPERIORITY|||||||0.9885|||||||Wilcoxon (Mann-Whitney)|2 sided Wilcoxon (Mann-Whitney)||Testing whether the changes from baseline to week 4 are significantly different between arms.||||0.9885
72616125|NCT01500096|144762891|SUPERIORITY|||||||0.2898|||||||Wilcoxon (Mann-Whitney)|2 sides Wilcoxon (Mann-Whitney)||Testing whether the changes from baseline to week 4 are significantly different between arms.||||0.2898
72616126|NCT01500096|144762892|SUPERIORITY|||||||0.6|||||||Wilcoxon (Mann-Whitney)|2 sided Wilcoxon (Mann-Whitney)||Testing whether the IL-6 level changes from baseline to week 4 are significantly different between arms.||||0.60
72554924|NCT03086460|144641764|SUPERIORITY||Mean Difference (Final Values)|0.158|||<|0.001|TWO_SIDED|95.0|0.095|0.22|||ANCOVA|||"Comparison groups were:~Treatment B (CHF 1531 pMDI 12 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.220|0.095|<0.001
72432184|NCT04319094|144376822|SUPERIORITY||Mean Difference (Net)|2.59|STANDARD_ERROR_OF_MEAN|1.03||0.0123|TWO_SIDED|95.0|0.57|4.62||The a priori threshold for statistical significance is p=0.05.|Mixed Models Analysis|Degrees of freedom: 361|Score difference: 3-month - baseline|Null hypothesis: there is no difference in the mean Brief-COPE Adaptive Coping scores from baseline to 3-month for all study participants.|A series of generalized linear mixed-effect models were implemented to predict the outcome measurements. The primary fixed effect predictors were group (control vs. PEERS), time (categorical), and group \* time. Random terms in all models were: study participants and their interaction with time. The covariance of dependent variable values across time was modeled as a first-order auto-regression decaying function (AR1). Higher order fixed and random terms were pretested and removed from the model if nonsignificant.|4.62|0.57|0.0123
72432185|NCT04319094|144376822|SUPERIORITY||Mean Difference (Net)|2.63|STANDARD_ERROR_OF_MEAN|1.02||0.01|TWO_SIDED|95.0|0.63|4.63||The a priori threshold for statistical significance is p=0.05.|Mixed Models Analysis|Degrees of freedom: 361|Score difference: 6-month - baseline|Null hypothesis: there is no difference in the mean Brief-COPE Adaptive Coping scores from baseline to 6-month for all study participants.|A series of generalized linear mixed-effect models were implemented to predict the outcome measurements. The primary fixed effect predictors were group (control vs. PEERS), time (categorical), and group \* time. Random terms in all models were: study participants and their interaction with time. The covariance of dependent variable values across time was modeled as a first-order auto-regression decaying function (AR1). Higher order fixed and random terms were pretested and removed from the model if nonsignificant.|4.63|0.63|0.01
72432186|NCT04319094|144376822|SUPERIORITY||Mean Difference (Net)|4.18|STANDARD_ERROR_OF_MEAN|0.95|<|0.0001|TWO_SIDED|95.0|2.32|6.04||The a priori threshold for statistical significance is p=0.05.|Mixed Models Analysis|Degrees of freedom: 361|Score difference: 9-month - baseline|Null hypothesis: there is no difference in the mean Brief-COPE Adaptive Coping scores from baseline to 9-month for all study participants.|A series of generalized linear mixed-effect models were implemented to predict the outcome measurements. The primary fixed effect predictors were group (control vs. PEERS), time (categorical), and group \* time. Random terms in all models were: study participants and their interaction with time. The covariance of dependent variable values across time was modeled as a first-order auto-regression decaying function (AR1). Higher order fixed and random terms were pretested and removed from the model if nonsignificant.|6.04|2.32|<0.0001
72432187|NCT04319094|144376822|SUPERIORITY||Mean Difference (Net)|3.14|STANDARD_ERROR_OF_MEAN|1.17||0.0078|TWO_SIDED|95.0|0.83|5.44||The a priori threshold for statistical significance is p=0.05.|Mixed Models Analysis|Degrees of freedom: 361|Score difference: 12-month - baseline|Null hypothesis: there is no difference in the mean Brief-COPE Adaptive Coping scores from baseline to 12-month for all study participants.|A series of generalized linear mixed-effect models were implemented to predict the outcome measurements. The primary fixed effect predictors were group (control vs. PEERS), time (categorical), and group \* time. Random terms in all models were: study participants and their interaction with time. The covariance of dependent variable values across time was modeled as a first-order auto-regression decaying function (AR1). Higher order fixed and random terms were pretested and removed from the model if nonsignificant.|5.44|0.83|0.0078
72432188|NCT04319094|144376822|SUPERIORITY|||||||0.1408|||||||Mixed Models Analysis|||Null hypothesis: there is no statistical difference in the change in adaptive coping over time between control and PEERS participants.||||0.1408
72432189|NCT04956692|144376823|NON_INFERIORITY|The non-inferiority margin with respect to the geometric means ratio (GMR) was 0.8|Geometric Mean Ratio (GMR)|1.04|||<|0.0001|TWO_SIDED|96.0|0.98|1.1||The one-sided p-value non-inferiority boundary is 0.02|t-test, 1 sided|Welch's unequal variances t-test. The null hypothesis was that GMR≤0.8.|Numerator Arm A/Denominator Arm B|||1.10|0.98|<0.0001
72432190|NCT04956692|144376824|NON_INFERIORITY|The non-inferiority margin with respect to the geometric means ratio (GMR) was 0.8|Geometric Mean Ratio (GMR)|1.85|||<|0.0001|TWO_SIDED|94.0|1.69|2.03||The one-sided p-value non-inferiority boundary is 0.03|t-test, 1 sided|Welch's unequal variances t-test. The null hypothesis was that GMR≤0.8.|Numerator Arm A/Denominator Arm B|||2.03|1.69|<0.0001
72432191|NCT04863898|144376839|SUPERIORITY||Mean Difference (Net)|-6.1|||||TWO_SIDED|95.0|-7.0|-5.2|||||LME regression, random intercepts by individual and fixed effects of participant characteristics. Difference = endline - baseline.|Using the PASS software program, we estimated the power for comparisons of scores from pre- to post-intervention, assuming a p-value of 0.05 (two-sided) and a final sample size of 131 with both measurements. We would have 85% power to detect a small-to-medium sized effect based on standardized mean difference (d=0.32).||-5.2|-7|
72554925|NCT03086460|144641764|SUPERIORITY||Mean Difference (Final Values)|0.133|||<|0.001|TWO_SIDED|95.0|0.072|0.194|||ANCOVA|||"Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.194|0.072|<0.001
72616127|NCT01500096|144762892|SUPERIORITY|||||||0.28|||||||Wilcoxon (Mann-Whitney)|2 sided Wilcoxon (Mann-Whitney)||Testing whether the IL-6 level changes from baseline to week 4 are significantly different between arms.||||0.28
72616128|NCT01500096|144762892|SUPERIORITY|||||||0.41|||||||Wilcoxon (Mann-Whitney)|2 sided Wilcoxon (Mann-Whitney)||Testing whether the sTNFR1 level changes from baseline to week 4 are significantly different between arms.||||0.41
72616129|NCT01500096|144762892|SUPERIORITY|||||||0.72|||||||Wilcoxon (Mann-Whitney)|2 sided Wilcoxon (Mann-Whitney)||Testing whether the sTNFR1 level changes from baseline to week 4 are significantly different between arms.||||0.72
72616130|NCT01500096|144762892|SUPERIORITY|||||||0.34|||||||Wilcoxon (Mann-Whitney)|2 sided Wilcoxon (Mann-Whitney)||Testing whether the sTNFR2 level changes from baseline to week 4 are significantly different between arms.||||0.34
72616131|NCT01500096|144762892|SUPERIORITY|||||||0.58|||||||Wilcoxon (Mann-Whitney)|2 sided Wilcoxon (Mann-Whitney)||Testing whether the sTNFR2 level changes from baseline to week 4 are significantly different between arms.||||0.58
72616132|NCT01500096|144762893|SUPERIORITY|||||||0.31|||||||Wilcoxon (Mann-Whitney)|2 sided Wilcoxon (Mann-Whitney)||Testing whether the changes from baseline to week 5 are significantly different between arms.||||0.31
72432192|NCT04863898|144376843|SUPERIORITY||Mean Difference (Net)|0.97|||||TWO_SIDED|95.0|0.86|1.09|||||Calculated using a linear mixed effect regression model with random intercepts by individual Difference = endline - baseline.|Using the PASS software program, we estimated the power for comparisons of scores from pre- to post-intervention, assuming a p-value of 0.05 (two-sided) and a final sample size of 131 with both measurements. We would have 85% power to detect a small-to-medium sized effect based on standardized mean difference (d=0.32).||1.09|0.86|
72432193|NCT04863898|144376844|SUPERIORITY||Mean Difference (Net)|-4.2|||||TWO_SIDED|95.0|-4.7|-3.6|||||LME regression, random intercepts by individual and fixed effects of participant characteristics. Difference = endline - baseline.|Using the PASS software program, we estimated the power for comparisons of scores from pre- to post-intervention, assuming a p-value of 0.05 (two-sided) and a final sample size of 131 with both measurements. We would have 85% power to detect a small-to-medium sized effect based on standardized mean difference (d=0.32).||-3.6|-4.7|
72432194|NCT00770211|144376845|SUPERIORITY_OR_OTHER||Difference response rate|0.48|STANDARD_ERROR_OF_MEAN|0.037|<|0.0001|TWO_SIDED|95.0|0.4|0.56|||Fisher Exact|||The efficacy of the treatment was confirmed, if H0 was rejected at a given alpha of 5%, that means if the two sided p-value is ≤ 0.05. Power of 90%||0.56|0.40|<0.0001
72432195|NCT00764868|144376850|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||t-test, 2 sided|t-test of LDX at baseline and 52 weeks||||||<0.001
72432196|NCT00764868|144376852|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||t-test, 2 sided|t-test of LDX at baseline and 52 weeks||||||<0.001
72432197|NCT03253653|144376865|OTHER||z score|1.578||||0.115|TWO_SIDED||||||Wilcoxon signed-rank test||||We used the Wilcoxon signed-rank test (two-tailed alpha level p \< 0.05), appropriate for within-subjects tests, to determine whether the pre-to-post change in biomarker levels for the Charcoal-heated tobacco smoking session (n=50) significantly different from the pre-to-post change in biomarker levels for the Electric Head-heated tobacco smoking session (using the same 50 participants after a weeklong washout period).|||0.115
72432198|NCT03253653|144376866|OTHER||z|0.497||||0.619|TWO_SIDED||||||z||||We used the Wilcoxon signed-rank test (two-tailed alpha level p \< 0.05), appropriate for within-subjects tests, to determine whether the pre-to-post change in biomarker levels for the Charcoal-heated tobacco smoking session (n=50) significantly different from the pre-to-post change in biomarker levels for the Electric Head-heated tobacco smoking session (using the same 50 participants after a weeklong washout period).|||0.619
72432199|NCT03253653|144376867|OTHER||z|1.72||||0.085|TWO_SIDED||||||Wilcox and signed rank test||||We used the Wilcoxon signed-rank test (two-tailed alpha level p \< 0.05), appropriate for within-subjects tests, to determine whether the pre-to-post change in biomarker levels for the Charcoal-heated tobacco smoking session (n=50) significantly different from the pre-to-post change in biomarker levels for the Electric Head-heated tobacco smoking session (using the same 50 participants after a weeklong washout period).|||0.085
72432200|NCT03253653|144376868|OTHER||z|6.154|||<|0.001|TWO_SIDED||||||Wilcoxon signed rank test||||We used the Wilcoxon signed-rank test (two-tailed alpha level p \< 0.05), appropriate for within-subjects tests, to determine whether the pre-to-post change in biomarker levels for the Charcoal-heated tobacco smoking session (n=50) significantly different from the pre-to-post change in biomarker levels for the Electric Head-heated tobacco smoking session (using the same 50 participants after a weeklong washout period).|||<0.001
72432201|NCT03253653|144376869|OTHER||z|-1.144||||0.253|TWO_SIDED||||||Wilcoxon signed rank test||||We used the Wilcoxon signed-rank test (two-tailed alpha level p \< 0.05), appropriate for within-subjects tests, to determine whether the pre-to-post change in systolic blood pressure for the Charcoal-heated tobacco smoking session (n=50) significantly different from the pre-to-post change in biomarker levels for the Electric Head-heated tobacco smoking session (using the same 50 participants after a weeklong washout period).|||0.253
72504436|NCT03726671|144539458|OTHER|||||||0.3984|||||||Mixed Models Analysis|The model evaluates effects from SNP, diet and SNP x diet interaction. Due to crossover design, period and sequence effects were adjusted in the model||Diet x SNP interaction effect on Choline IER in Post-Menopausal Females||||0.3984
72616133|NCT01500096|144762893|SUPERIORITY|||||||0.71|||||||Wilcoxon (Mann-Whitney)|2 sided Wilcoxon (Mann-Whitney)||Testing whether the changes from baseline to week 4 are significantly different between arms.||||0.71
72616134|NCT01500096|144762894|SUPERIORITY|||||||0.18|||||||Wilcoxon (Mann-Whitney)|2 sided Wilcoxon (Mann-Whitney)||Testing whether the changes from baseline to week 4 are significantly different between arms.||||0.18
72616135|NCT01500096|144762894|SUPERIORITY|||||||0.19|||||||Wilcoxon (Mann-Whitney)|2 sided Wilcoxon (Mann-Whitney)||Testing whether the changes from baseline to week 4 are significantly different between arms.||||0.19
72616136|NCT01500096|144762895|SUPERIORITY|||||||0.47|||||||Wilcoxon (Mann-Whitney)|2 sided Wilcoxon (Mann-Whitney)||Testing whether the changes from baseline to week 4 are significantly different between arms.||||0.47
72616137|NCT01500096|144762895|SUPERIORITY|||||||0.41|||||||Wilcoxon (Mann-Whitney)|2 sided Wilcoxon (Mann-Whitney)||Testing whether the changes from baseline to week 4 are significantly different between arms.||||0.41
72616138|NCT01734928|144762897|SUPERIORITY||Hazard Ratio (HR)|0.61||||0.001|TWO_SIDED|95.0|0.49|0.77|||Based on Cox proportional hazards model|||||0.77|0.49|0.001
72616139|NCT01734928|144762898|SUPERIORITY||Hazard Ratio (HR)|0.94||||0.571|TWO_SIDED|95.0|0.77|1.15|||Log Rank|The p-value is based on a stratified log-rank test with stratification factors as above Cox model.|Based on Cox proportional hazards model, comparing the hazard functions associated with treatment groups, stratified by age, prior number of anti-myeloma regimens, and beta-2 macroglobulin at Screening.|||1.15|0.77|0.571
72616140|NCT01734928|144762900|SUPERIORITY||Hazard Ratio (HR)|0.76||||0.064|TWO_SIDED|95.0|0.56|1.02|||Unstratified log-rank test|The p-value is based on an unstratified log-rank test.|Based on Cox proportional hazards model comparing the hazard functions associated with treatment groups|||1.02|0.56|0.064
72432202|NCT03253653|144376870|OTHER||z|-1.004||||0.315|TWO_SIDED||||||Wilcoxon signed rank test||||We used the Wilcoxon signed-rank test (two-tailed alpha level p \< 0.05), appropriate for within-subjects tests, to determine whether the pre-to-post change in diastolic blood pressure for the Charcoal-heated tobacco smoking session (n=50) significantly different from the pre-to-post change in diastolic blood pressure for the Electric Head-heated tobacco smoking session (using the same 50 participants after a weeklong washout period).|||0.315
72504437|NCT03726671|144539458|OTHER|||||||0.308|||||||Mixed Models Analysis|The model evaluates effects from SNP, diet and SNP x diet interaction. Due to crossover design, period and sequence effects were adjusted in the model||Diet x SNP interaction effect on Choline IER in Males||||0.3080
72616141|NCT01952678|144762937|EQUIVALENCE|Analysis was performed using the hypothesis: PPA was equal for Caucasian and non-Caucasian populations.|Mean Difference (Net)|1.8||||1|TWO_SIDED|95.0|-17.3|20.7|||Fisher Exact|||Reader A: DaTscan™- Non-Caucasian Participants vs DaTscan™- Caucasian Participants||20.7|-17.3|1.0000
72616142|NCT01952678|144762937|EQUIVALENCE|Analysis was performed using the hypothesis: PPA was equal for Caucasian and non-Caucasian populations.|Mean Difference (Net)|-7.0||||0.4608|TWO_SIDED|95.0|-25.8|12.1|||Fisher Exact|||Reader B: DaTscan™- Non-Caucasian Participants vs DaTscan™- Caucasian Participants||12.1|-25.8|0.4608
72616143|NCT01952678|144762937|EQUIVALENCE|Analysis was performed using the hypothesis: PPA was equal for Caucasian and non-Caucasian populations.|Mean Difference (Net)|1.8||||1|TWO_SIDED|95.0|-17.3|20.7|||Fisher Exact|||Reader C: DaTscan™- Non-Caucasian Participants vs DaTscan™- Caucasian Participants||20.7|-17.3|1.0000
72616144|NCT01952678|144762937|EQUIVALENCE|Analysis was performed using the hypothesis: PPA was equal for Caucasian and non-Caucasian populations.|Mean Difference (Net)|1.8||||1|TWO_SIDED|95.0|-17.3|20.7|||Fisher Exact|||Majority Read: DaTscan™- Non-Caucasian Participants vs DaTscan™- Caucasian Participants||20.7|-17.3|1.0000
72616145|NCT01952678|144762938|EQUIVALENCE|Analysis was performed using the hypothesis: PPA was equal for Caucasian and non-Caucasian populations.|Mean Difference (Net)|1.8||||1|TWO_SIDED|95.0|-17.5|20.9|||Fisher Exact|||Reader A: DaTscan™- Non-Caucasian Participants vs DaTscan™- Caucasian Participants||20.9|-17.5|1.0000
72616146|NCT01952678|144762938|EQUIVALENCE|Analysis was performed using the hypothesis: PPA was equal for Caucasian and non-Caucasian populations.|Mean Difference (Net)|-7.1||||0.4599|TWO_SIDED|95.0|-26.1|12.2|||Fisher Exact|||Reader B: DaTscan™- Non-Caucasian Participants vs DaTscan™- Caucasian Participants||12.2|-26.1|0.4599
72616147|NCT01952678|144762938|EQUIVALENCE|Analysis was performed using the hypothesis: PPA was equal for Caucasian and non-Caucasian populations.|Mean Difference (Net)|1.8||||1|TWO_SIDED|95.0|-17.5|20.9|||Fisher Exact|||Reader C: DaTscan™- Non-Caucasian Participants vs DaTscan™- Caucasian Participants||20.9|-17.5|1.0000
72616148|NCT01952678|144762938|EQUIVALENCE|Analysis was performed using the hypothesis: PPA was equal for Caucasian and non-Caucasian populations.|Mean Difference (Net)|1.8||||1|TWO_SIDED|95.0|-17.5|20.9|||Fisher Exact|||Majority Read: DaTscan™- Non-Caucasian Participants vs DaTscan™- Caucasian Participants||20.9|-17.5|1.0000
72616149|NCT01952678|144762939|EQUIVALENCE|Analysis was performed using the hypothesis: NPA was equal for Caucasian and non-Caucasian populations.|Mean Difference (Net)|0.0||||1|TWO_SIDED|95.0|-22.0|22.0|||Fisher Exact|||Reader A: DaTscan™- Non-Caucasian Participants vs DaTscan™- Caucasian Participants||22.0|-22.0|1.0000
72616150|NCT01952678|144762939|EQUIVALENCE|Analysis was performed using the hypothesis: NPA was equal for Caucasian and non-Caucasian populations.|Mean Difference (Net)|0.4||||1|TWO_SIDED|95.0|-20.8|20.8|||Fisher Exact|||Reader B: DaTscan™- Non-Caucasian Participants vs DaTscan™- Caucasian Participants||20.8|-20.8|1.0000
72616151|NCT01952678|144762939|EQUIVALENCE|Analysis was performed using the hypothesis: NPA was equal for Caucasian and non-Caucasian populations.|Mean Difference (Net)|-2.0||||1|TWO_SIDED|95.0|-23.0|18.5|||Fisher Exact|||Reader C: DaTscan™- Non-Caucasian Participants vs DaTscan™- Caucasian Participants||18.5|-23.0|1.0000
72616152|NCT01952678|144762939|EQUIVALENCE|Analysis was performed using the hypothesis: NPA was equal for Caucasian and non-Caucasian populations.|Mean Difference (Net)|0.3||||1|TWO_SIDED|95.0|-20.8|20.8|||Fisher Exact|||Majority Read: DaTscan™- Non-Caucasian Participants vs DaTscan™- Caucasian Participants||20.8|-20.8|1.0000
72616153|NCT01952678|144762940|EQUIVALENCE|Analysis was performed using the hypothesis: NPA was equal for Caucasian and non-Caucasian populations.|Mean Difference (Net)|0.0||||1|TWO_SIDED|95.0|-22.8|22.8|||Fisher Exact|||Reader A: DaTscan™- Non-Caucasian Participants vs DaTscan™- Caucasian Participants||22.8|-22.8|1.0000
72616154|NCT01952678|144762940|EQUIVALENCE|Analysis was performed using the hypothesis: NPA was equal for Caucasian and non-Caucasian populations.|Mean Difference (Net)|5.2||||0.5187|TWO_SIDED|95.0|-16.7|26.2|||Fisher Exact|||Reader B: DaTscan™- Non-Caucasian Participants vs DaTscan™- Caucasian Participants||26.2|-16.7|0.5187
72616155|NCT01952678|144762940|EQUIVALENCE|Analysis was performed using the hypothesis: NPA was equal for Caucasian and non-Caucasian populations.|Mean Difference (Net)|0.2||||1|TWO_SIDED|95.0|-21.5|21.5|||Fisher Exact|||Reader C: DaTscan™- Non-Caucasian Participants vs DaTscan™- Caucasian Participants||21.5|-21.5|1.0000
72616156|NCT01952678|144762940|EQUIVALENCE|Analysis was performed using the hypothesis: NPA was equal for Caucasian and non-Caucasian populations.|Mean Difference (Net)|2.7||||0.7123|TWO_SIDED|95.0|-19.1|23.9|||Fisher Exact|||Majority Read: DaTscan™- Non-Caucasian Participants vs DaTscan™- Caucasian Participants||23.9|-19.1|0.7123
72616157|NCT01952678|144762941|EQUIVALENCE|Analysis was performed using the hypothesis: OPA was equal for Caucasian and non-Caucasian populations.|Mean Difference (Net)|1.0||||1|TWO_SIDED|95.0|-13.3|15.3|||Fisher Exact|||Reader A: DaTscan™- Non-Caucasian Participants vs DaTscan™- Caucasian Participants||15.3|-13.3|1.0000
72616158|NCT01952678|144762941|EQUIVALENCE|Analysis was performed using the hypothesis: OPA was equal for Caucasian and non-Caucasian populations.|Mean Difference (Net)|-3.8||||0.5731|TWO_SIDED|95.0|-17.7|9.8|||Fisher Exact|||Reader B: DaTscan™- Non-Caucasian Participants vs DaTscan™- Caucasian Participants||9.8|-17.7|0.5731
72616159|NCT01952678|144762941|EQUIVALENCE|Analysis was performed using the hypothesis: OPA was equal for Caucasian and non-Caucasian populations.|Mean Difference (Net)|0.1||||1|TWO_SIDED|95.0|-13.8|13.8|||Fisher Exact|||Reader C: DaTscan™- Non-Caucasian Participants vs DaTscan™- Caucasian Participants||13.8|-13.8|1.0000
72432203|NCT03253653|144376871|OTHER||z|3.089||||0.002|TWO_SIDED||||||Wilcox and signed rank test||||We used the Wilcoxon signed-rank test (two-tailed alpha level p \< 0.05), appropriate for within-subjects tests, to determine whether the pre-to-post change in heart rate for the Charcoal-heated tobacco smoking session (n=50) was significantly different from the pre-to-post change in heart rate for the Electric Head-heated tobacco smoking session (using the same 50 participants after a weeklong washout period).|||0.002
72371569|NCT00669409|144253440|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-17.8|STANDARD_ERROR_OF_MEAN|7.98|||TWO_SIDED|95.0|-33.6|-2.1||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-2.1|-33.6|
72432204|NCT03253653|144376872|OTHER||z|-7.024|||<|0.001|TWO_SIDED||||||Mann-Whitney U rank sum test||||We used the Mann-Whitney U rank sum test (two-tailed alpha level p \< 0.05), appropriate for between-subjects analyses, to determine whether level of the cotinine metabolite after a tobacco smoking session for n=50 smokers differed from the level for n=25 non-smokers.|||<0.001
72432205|NCT03253653|144376873|OTHER||z|-4.541|||<|0.001|TWO_SIDED||||||Mann-Whitney U rank sum test||||We used the Mann-Whitney U rank sum test (two-tailed alpha level p \< 0.05), appropriate for between-subjects analyses, to determine whether level of the SPMA metabolite after a tobacco smoking session for n=50 smokers differed from the level for n=25 non-smokers.|||<0.001
72371570|NCT00669409|144253440|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-1.4|STANDARD_ERROR_OF_MEAN|7.99|||TWO_SIDED|95.0|-17.2|14.4||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||14.4|-17.2|
72371571|NCT00669409|144253440|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-11.2|STANDARD_ERROR_OF_MEAN|7.88|||TWO_SIDED|95.0|-26.7|4.4||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||4.4|-26.7|
72432206|NCT03253653|144376874|OTHER||z|-2.569||||0.01|TWO_SIDED||||||Mann-Whitney U rank sum test||||We used the Mann-Whitney U rank sum test (two-tailed alpha level p \< 0.05), appropriate for between-subjects analyses, to determine whether level of the 1-HOP metabolite after a tobacco smoking session for n=50 smokers differed from the level for n=25 non-smokers.|||.010
72616160|NCT01952678|144762941|EQUIVALENCE|Analysis was performed using the hypothesis: OPA was equal for Caucasian and non-Caucasian populations.|Mean Difference (Net)|1.1||||0.834|TWO_SIDED|95.0|-12.8|14.7|||Fisher Exact|||Majority Read: DaTscan™- Non-Caucasian Participants vs DaTscan™- Caucasian Participants||14.7|-12.8|0.8340
72504438|NCT03726671|144539458|OTHER|||||||0.7603|||||||Mixed Models Analysis|The model evaluates effects from SNP, diet and SNP x diet interaction. Due to crossover design, period and sequence effects were adjusted in the model||Diet x SNP interaction effect on Phosphatidylcholine IER in Pre-Menopausal Females||||0.7603
72616161|NCT01952678|144762942|EQUIVALENCE|Analysis was performed using the hypothesis: OPA was equal for Caucasian and non-Caucasian populations.|Mean Difference (Net)|1.0||||1|TWO_SIDED|95.0|-13.5|15.6|||Fisher Exact|||Reader A: DaTscan™- Non-Caucasian Participants vs DaTscan™- Caucasian Participants||15.6|-13.5|1.0000
72616162|NCT01952678|144762942|EQUIVALENCE|Analysis was performed using the hypothesis: OPA was equal for Caucasian and non-Caucasian populations.|Mean Difference (Net)|-1.9||||0.8429|TWO_SIDED|95.0|-16.1|12.0|||Fisher Exact|||Reader B: DaTscan™- Non-Caucasian Participants vs DaTscan™- Caucasian Participants||12.0|-16.1|0.8429
72616163|NCT01952678|144762942|EQUIVALENCE|Analysis was performed using the hypothesis: OPA was equal for Caucasian and non-Caucasian populations.|Mean Difference (Net)|1.1||||0.8214|TWO_SIDED|95.0|-13.0|15.0|||Fisher Exact|||Reader C: DaTscan™- Non-Caucasian Participants vs DaTscan™- Caucasian Participants||15.0|-13.0|0.8214
72616164|NCT01952678|144762942|EQUIVALENCE|Analysis was performed using the hypothesis: OPA was equal for Caucasian and non-Caucasian populations.|Mean Difference (Net)|2.2||||0.6577|TWO_SIDED|95.0|-12.0|16.1|||Fisher Exact|||Majority Read: DaTscan™- Non-Caucasian Participants vs DaTscan™- Caucasian Participants||16.1|-12.0|0.6577
72616165|NCT00845182|144762970|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||ANCOVA|||||||<0.05
72616166|NCT00845182|144762970|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||ANOVA|||||||<0.05
72616167|NCT01625182|144762973|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.0||||0.9838|TWO_SIDED|95.0|0.6|1.7|||Regression, Cox|||||1.7|0.6|0.9838
72616168|NCT00447278|144762979|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-4.36|||<|0.001|TWO_SIDED|95.0|-6.47|-2.25||P-value for Change from Baseline at 6 Months. P-value is not adjusted and the threshold is 0.05.|Mixed Models Analysis|Mixed model repeated measure analysis with terms for corresponding baseline T-score, treatment, country, visit, and treatment-by-visit interaction.|Least Squares Mean Difference = Atomoxetine minus OEST.|||-2.25|-6.47|<0.001
72616169|NCT00447278|144762979|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-4.6|||<|0.001|TWO_SIDED|95.0|-6.56|-2.63||P-value for Change from Baseline: 6 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.|||-2.63|-6.56|<0.001
72616170|NCT00447278|144762980|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-3.1||||0.002|TWO_SIDED|95.0|-5.08|-1.13||P-value for Change from Baseline: 4 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.|||-1.13|-5.08|0.002
72616171|NCT00447278|144762981|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-3.04||||0.002|TWO_SIDED|95.0|-4.92|-1.15||P-value for Comfort Change at 4 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.|||-1.15|-4.92|0.002
72616172|NCT00447278|144762981|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-2.1||||0.031|TWO_SIDED|95.0|-4.01|-0.2||P-value for Comfort Change at 6 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.|||-0.20|-4.01|0.031
72616173|NCT00447278|144762981|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.55||||0.629|TWO_SIDED|95.0|-1.68|2.77||P-value for Resilience Change at 4 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.|||2.77|-1.68|0.629
72616174|NCT00447278|144762981|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.96||||0.421|TWO_SIDED|95.0|-3.3|1.38||P-value for Resilience Change at 6 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.|||1.38|-3.30|0.421
72616175|NCT00447278|144762981|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-1.05||||0.388|TWO_SIDED|95.0|-3.44|1.34||P-value for Risk Avoidance Change: 4 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.|||1.34|-3.44|0.388
72616176|NCT00447278|144762981|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-2.29||||0.059|TWO_SIDED|95.0|-4.66|0.09||P-value for Risk Avoidance Change: 6 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.|||0.09|-4.66|0.059
72616177|NCT00447278|144762981|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-3.56||||0.006|TWO_SIDED|95.0|-6.09|-1.04||P-value for Satisfaction Change at 4 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.|||-1.04|-6.09|0.006
72616178|NCT00447278|144762981|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-2.91||||0.027|TWO_SIDED|95.0|-5.49|-0.33||P-value for Satisfaction Change at 6 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.|||-0.33|-5.49|0.027
72616179|NCT00447278|144762982|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.073||||0.015|TWO_SIDED|95.0|0.014|0.131||P-value for Total Change at 4 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.|||0.131|0.014|0.015
72616180|NCT00447278|144762982|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.085||||0.004|TWO_SIDED|95.0|0.027|0.143||P-value for Total Change at 6 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.|||0.143|0.027|0.004
72616181|NCT00447278|144762982|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.094||||0.063|TWO_SIDED|95.0|-0.005|0.192||P-value for Home Change at 4 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.|||0.192|-0.005|0.063
72616182|NCT00447278|144762982|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.075||||0.131|TWO_SIDED|95.0|-0.022|0.172||P-value for Home Change at 6 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.|||0.172|-0.022|0.131
72616183|NCT00447278|144762982|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.052||||0.156|TWO_SIDED|95.0|-0.02|0.124||P-value for Daily Living Change at 4 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.|||0.124|-0.020|0.156
72616184|NCT00447278|144762982|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.072||||0.046|TWO_SIDED|95.0|0.001|0.143||P-value for Daily Living Change at 6 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.|||0.143|0.001|0.046
72432207|NCT03253653|144376875|OTHER||z|-7.03|||<|0.001|TWO_SIDED||||||Mann-Whitney U rank sum test||||We used the Mann-Whitney U rank sum test (two-tailed alpha level p \< 0.05), appropriate for between-subjects analyses, to determine whether level of the exhaled carbon monoxide after a tobacco smoking session for n=50 smokers differed from the level for n=25 non-smokers.|||<0.001
72432208|NCT03253653|144376876|OTHER||z|-1.304||||0.192|TWO_SIDED||||||Mann-Whitney U test||||We used the Mann-Whitney U rank sum test (two-tailed alpha level p \< 0.05), appropriate for between-subjects analyses, to determine whether level of the cotinine metabolite after a tobacco smoking session for n=50 smokers differed from the level for n=25 non-smokers.|||0.192
72432209|NCT03253653|144376877|OTHER||z|-2.136||||0.033|TWO_SIDED||||||Mann-Whitney U rank sum test||||We used the Mann-Whitney U rank sum test (two-tailed alpha level p \< 0.05), appropriate for between-subjects analyses, to determine whether level diastolic blood pressure after a tobacco smoking session for n=50 smokers differed from the level for n=25 non-smokers.|||0.033
72432210|NCT03253653|144376878|OTHER||z|-1.22||||0.223|TWO_SIDED||||||Mann-Whitney U rank sum test||||We used the Mann-Whitney U rank sum test (two-tailed alpha level p \< 0.05), appropriate for between-subjects analyses, to determine whether level of the heart rate after a tobacco smoking session for n=50 smokers differed from the level for n=25 non-smokers.|||0.223
72432211|NCT03253653|144376879|OTHER||z|-7.024|||<|0.001|TWO_SIDED||||||Mann Whitney U rank sum test||||We used the Mann-Whitney U rank sum test (two-tailed alpha level p \< 0.05), appropriate for between-subjects analyses, to determine whether level of the cotinine metabolite after a tobacco smoking session for n=50 smokers differed from the level for n=25 non-smokers.|||<0.001
72432212|NCT03253653|144376880|OTHER||z|-1.248||||0.212|TWO_SIDED||||||Mann-Whitney U rank sum test||||We used the Mann-Whitney U rank sum test (two-tailed alpha level p \< 0.05), appropriate for between-subjects analyses, to determine whether level of the SPMA metabolite after a tobacco smoking session for n=50 smokers differed from the level for n=25 non-smokers.|||0.212
72371572|NCT00669409|144253440|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-25.8|STANDARD_ERROR_OF_MEAN|10.48|||TWO_SIDED|95.0|-46.5|-5.0||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-5.0|-46.5|
72616185|NCT00447278|144762982|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.04||||0.068|TWO_SIDED|95.0|-0.003|0.084||P-value for Risk Taking Change at 4 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.|||0.084|-0.003|0.068
72616186|NCT00447278|144762982|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.028||||0.212|TWO_SIDED|95.0|-0.016|0.073||P-value for Risk Taking Change at 6 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.|||0.073|-0.016|0.212
72616187|NCT00447278|144762982|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.121||||0.006|TWO_SIDED|95.0|0.034|0.208||P-value for School Change at 4 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.|||0.208|0.034|0.006
72616188|NCT00447278|144762982|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.15|||<|0.001|TWO_SIDED|95.0|0.064|0.236||P-value for School Change at 6 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.|||0.236|0.064|<0.001
72616189|NCT00447278|144762982|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.125||||0.034|TWO_SIDED|95.0|0.009|0.24||P-value for Self-Concept Change at 4 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.|||0.240|0.009|0.034
72616190|NCT00447278|144762982|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.119||||0.04|TWO_SIDED|95.0|0.005|0.233||P-value for Self-Concept Change at 6 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.|||0.233|0.005|0.040
72616191|NCT00447278|144762982|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.085||||0.042|TWO_SIDED|95.0|0.003|0.166||p-value for Social Change at 4 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.|||0.166|0.003|0.042
72616192|NCT00447278|144762982|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.048||||0.271|TWO_SIDED|95.0|-0.038|0.134||P-value for Social Change at 6 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.|||0.134|-0.038|0.271
72616193|NCT00447278|144762983|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|2.307||||0.034|TWO_SIDED|95.0|0.173|4.44||P-value for Total Change at 4 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.|||4.440|0.173|0.034
72616194|NCT00447278|144762983|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|3.072||||0.005|TWO_SIDED|95.0|0.942|5.202||P-value for Total Change at 6 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.|||5.202|0.942|0.005
72616195|NCT00447278|144762983|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|1.721||||0.004|TWO_SIDED|95.0|0.544|2.899||P-value for Inattention Change at 4 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.|||2.899|0.544|0.004
72432213|NCT03253653|144376881|OTHER||z|-2.721||||0.007|TWO_SIDED||||||Mann-Whitney U rank sum test||||We used the Mann-Whitney U rank sum test (two-tailed alpha level p \< 0.05), appropriate for between-subjects analyses, to determine whether level of the cotinine metabolite after a tobacco smoking session for n=50 smokers differed from the level for n=25 non-smokers.|||0.007
72432214|NCT03253653|144376882|OTHER||z|2.778||||0.006|TWO_SIDED||||||Mann-Whitney U rank sum test||||We used the Mann-Whitney U rank sum test (two-tailed alpha level p \< 0.05), appropriate for between-subjects analyses, to determine whether level of exhaled carbon monoxide after a tobacco smoking session for n=50 smokers differed from the level for n=25 non-smokers.|||0.006
72616196|NCT00447278|144762983|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|2.269|||<|0.001|TWO_SIDED|95.0|1.086|3.453||P-value for Inattention Change at 6 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.|||3.453|1.086|<0.001
72616197|NCT00447278|144762983|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.58||||0.298|TWO_SIDED|95.0|-0.515|1.676||P-value for Hyperactivity Change at 4 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.|||1.676|-0.515|0.298
72616198|NCT00447278|144762983|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.865||||0.119|TWO_SIDED|95.0|-0.225|1.956||P-value for Hyperactivity Change at 6 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.|||1.956|-0.225|0.119
72616199|NCT00447278|144762984|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.104||||0.366|TWO_SIDED|95.0|-0.122|0.329||P-value for Change at 4 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.|||0.329|-0.122|0.366
72616200|NCT00447278|144762984|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.169||||0.165|TWO_SIDED|95.0|-0.07|0.407||P-value for Change at 6 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.|||0.407|-0.070|0.165
72616201|NCT00447278|144762985|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-2.35||||0.054|TWO_SIDED|95.0|-4.74|0.04||P-value for Achievement Change at 4 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.|||0.04|-4.74|0.054
72616202|NCT00447278|144762985|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-3.71||||0.003|TWO_SIDED|95.0|-6.16|-1.26||P-value for Achievement Change at 6 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.|||-1.26|-6.16|0.003
72616203|NCT00447278|144762985|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-1.74||||0.033|TWO_SIDED|95.0|-3.33|-0.14||P-value for Comfort Change at 4 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.|||-0.14|-3.33|0.033
72616204|NCT00447278|144762985|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-2.5||||0.003|TWO_SIDED|95.0|-4.12|-0.88||P-value for Comfort Change at 6 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.|||-0.88|-4.12|0.003
72616205|NCT00447278|144762985|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.5||||0.623|TWO_SIDED|95.0|-1.5|2.5||P-value for Resilience Change at 4 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.|||2.50|-1.50|0.623
72616206|NCT00447278|144762985|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.16||||0.88|TWO_SIDED|95.0|-1.96|2.29||P-value for Resilience Change at 6 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.|||2.29|-1.96|0.880
72616207|NCT00447278|144762985|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-1.4||||0.149|TWO_SIDED|95.0|-3.31|0.5||P-value for Risk Avoidance Change: 4 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.|||0.50|-3.31|0.149
72616208|NCT00447278|144762985|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-2.78||||0.003|TWO_SIDED|95.0|-4.58|-0.98||P-value for Risk Avoidance Change: 6 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.|||-0.98|-4.58|0.003
72616209|NCT00447278|144762985|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-2.62||||0.015|TWO_SIDED|95.0|-4.71|-0.52||P-value for Satisfaction Change at 4 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.|||-0.52|-4.71|0.015
72616210|NCT00447278|144762985|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-3.12||||0.004|TWO_SIDED|95.0|-5.26|-0.98||P-value for Satisfaction Change at 6 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.|||-0.98|-5.26|0.004
72616211|NCT00447278|144762986|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|2.39||||0.263|TWO_SIDED|95.0|-1.83|6.6||P-value for Achievement Change at 4 Month LOCF. Achievement was derived from the academic achievement subdomain only.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.|||6.60|-1.83|0.263
72616212|NCT00447278|144762986|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.38||||0.848|TWO_SIDED|95.0|-3.6|4.36||P-value for Achievement Change at 6 Month LOCF. Achievement was derived from the academic achievement subdomain only.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.|||4.36|-3.60|0.848
72616213|NCT00447278|144762986|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.19||||0.895|TWO_SIDED|95.0|-3.01|2.64||P-value for Statisfaction Change at 4 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.|||2.64|-3.01|0.895
72616214|NCT00447278|144762986|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-3.2||||0.038|TWO_SIDED|95.0|-6.22|-0.19||P-value for Satisfaction Change at 6 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.|||-0.19|-6.22|0.038
72616215|NCT00447278|144762986|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.3||||0.854|TWO_SIDED|95.0|-3.59|2.98||P-value for Comfort Change at 4 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.|||2.98|-3.59|0.854
72616216|NCT00447278|144762986|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-2.26||||0.161|TWO_SIDED|95.0|-5.45|0.92||P-value for Comfort Change at 6 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.|||0.92|-5.45|0.161
72616217|NCT00447278|144762986|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.7||||0.54|TWO_SIDED|95.0|-2.98|1.58||P-value for Risk Avoidance Change: 4 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.|||1.58|-2.98|0.540
72616218|NCT00447278|144762986|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-1.98||||0.106|TWO_SIDED|95.0|-4.4|0.44||P-value for Risk Avoidance Change: 6 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.|||0.44|-4.40|0.106
72616219|NCT00447278|144762986|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.3||||0.833|TWO_SIDED|95.0|-2.49|3.08||P-value for Resilience Change at 4 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.|||3.08|-2.49|0.833
72616220|NCT00447278|144762986|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-2.34||||0.11|TWO_SIDED|95.0|-5.21|0.54||P-value for Resilience Change at 6 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.|||0.54|-5.21|0.110
72432215|NCT03253653|144376883|OTHER||z|-0.832||||0.406|TWO_SIDED||||||Mann-Whitney U rank sum test||||We used the Mann-Whitney U rank sum test (two-tailed alpha level p \< 0.05), appropriate for between-subjects analyses, to determine whether level of systolic blood pressure after a tobacco smoking session for n=50 smokers differed from the level for n=25 non-smokers.|||0.406
72432216|NCT03253653|144376884|OTHER||z|-1.467||||0.142|TWO_SIDED||||||Mann-Whitney U ranksum test||||We used the Mann-Whitney U rank sum test (two-tailed alpha level p \< 0.05), appropriate for between-subjects analyses, to determine whether level of diastolic blood pressure after a tobacco smoking session for n=50 smokers differed from the level for n=25 non-smokers.|||0.142
72616221|NCT01286324|144763006|SUPERIORITY|||||||0.21||||||Adjusted p-value based on a general linear model adjusted for group and the baseline of the measure|t-test, 2 sided|||||||0.21
72616222|NCT01286324|144763007|SUPERIORITY|||||||0.6||||||Adjusted p-value based on a general linear model adjusted for group and the baseline of the measure|t-test, 2 sided|||||||0.60
72616223|NCT01286324|144763008|SUPERIORITY|||||||0.47||||||Adjusted p-value based on a general linear model adjusted for group and the baseline of the measure|t-test, 2 sided|||Statistical Analysis for State Subscale||||0.47
72616224|NCT01286324|144763008|SUPERIORITY|||||||0.45||||||Adjusted p-value based on a general linear model adjusted for group and the baseline of the measure|t-test, 2 sided|||P-value for Trait Subscale||||0.45
72616225|NCT01286324|144763009|SUPERIORITY|||||||0.11||||||P value is adjusted based on a general linear model adjusted for group and the baseline of the measure|t-test, 2 sided|||||||0.11
72616226|NCT05558410|144763022|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
72616227|NCT05558410|144763023|SUPERIORITY|||||||0.2781|||||||ANCOVA|||||||0.2781
72616228|NCT05558410|144763024|SUPERIORITY||||||<|0.0001|||||||Log Rank|||||||<0.0001
72616229|NCT05558410|144763025|SUPERIORITY||||||<|0.0001|||||||Log Rank|||||||<0.0001
72616230|NCT05558410|144763026|SUPERIORITY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
72616231|NCT05558410|144763027|SUPERIORITY||||||<|0.0001|||||||Pearson's chi-squared test|||||||<0.0001
72616232|NCT05558410|144763028|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
72616233|NCT05558410|144763029|SUPERIORITY||||||<|0.0001|||||||Log Rank|||||||<0.0001
72616234|NCT05558410|144763030|SUPERIORITY|||||||0.0237|||||||Cochran-Mantel-Haenszel|||||||0.0237
72616235|NCT05558410|144763031|SUPERIORITY|||||||0.008|||||||Wilcoxon rank-sum|||||||0.0080
72616236|NCT03501277|144763131|EQUIVALENCE|Alogliptin: For each analyte, an analysis of variance (ANOVA) was performed on natural logarithm transformed Cmax with factors for sequence, the participant nested within sequence, period, and regimen. For the relative bioavailability (BA) determination, pairwise comparisons were performed to assess the relative BA of alogliptin and pioglitazone via point estimates and 90 percent (%) confidence interval (CI) for the ratio of Cmax for Regimen A (test) versus Regimen B (reference).|Least Square Mean (LSM) difference|1.0706||||0.014|TWO_SIDED|90.0|1.023|1.1204|||ANOVA|||||1.1204|1.0230|0.014
72616237|NCT03501277|144763131|EQUIVALENCE|Alogliptin: For each analyte, ANOVA was performed on natural logarithm transformed Cmax with factors for sequence, the participant nested within sequence, period, and regimen. For the relative BA determination, pairwise comparisons were performed to assess the relative BA of alogliptin and pioglitazone via point estimates and 90% CI for the ratio of Cmax for Regimen C (test) versus Regimen D (reference).|LSM difference|1.0276||||0.326|TWO_SIDED|90.0|0.9817|1.0757|||ANOVA|||||1.0757|0.9817|0.326
72616238|NCT03501277|144763131|EQUIVALENCE|Pioglitazone: For each analyte, ANOVA was performed on natural logarithm transformed Cmax with factors for sequence, the participant nested within sequence, period, and regimen. For the relative BA determination, pairwise comparisons were performed to assess the relative BA of alogliptin and pioglitazone via point estimates and 90% CI for the ratio of Cmax for Regimen A (test) versus Regimen B (reference).|LSM diiference|0.9594||||0.405|TWO_SIDED|90.0|0.8837|1.0415|||ANOVA|||||1.0415|0.8837|0.405
72616239|NCT03501277|144763131|EQUIVALENCE|Pioglitazone: For each analyte, ANOVA was performed on natural logarithm transformed Cmax with factors for sequence, the participant nested within sequence, period, and regimen. For the relative BA determination, pairwise comparisons were performed to assess the relative BA of alogliptin and pioglitazone via point estimates and 90% CI for the ratio of Cmax for Regimen C (test) versus Regimen D (reference).|LSM difference|0.9257||||0.124|TWO_SIDED|90.0|0.8523|1.0053|||ANOVA|||||1.0053|0.8523|0.124
72616240|NCT03501277|144763132|EQUIVALENCE|Alogliptin: For each analyte, ANOVA was performed on natural logarithm transformed AUC(0-72) with factors for sequence, the participant nested within sequence, period, and regimen. For the relative BA determination, pairwise comparisons were performed to assess the relative BA of alogliptin and pioglitazone via point estimates and 90% CI for the ratio of Cmax for Regimen A (test) versus Regimen B (reference).|LSM difference|1.0157||||0.081|TWO_SIDED|90.0|1.0009|1.0308|||ANOVA|||||1.0308|1.0009|0.081
72616241|NCT03501277|144763132|EQUIVALENCE|Alogliptin: For each analyte, ANOVA was performed on natural logarithm transformed AUC(0-72) with factors for sequence, the participant nested within sequence, period, and regimen. For the relative BA determination, pairwise comparisons were performed to assess the relative BA of alogliptin and pioglitazone via point estimates and 90% CI for the ratio of AUC(0-72) for Regimen C (test) versus Regimen D (reference).|LSM difference|1.0009||||0.922|TWO_SIDED|90.0|0.9862|1.0158|||ANOVA|||||1.0158|0.9862|0.922
72616242|NCT03501277|144763132|EQUIVALENCE|Pioglitazone: For each analyte, ANOVA was performed on natural logarithm transformed AUC(0-72) with factors for sequence, the participant nested within sequence, period, and regimen. For the relative BA determination, pairwise comparisons were performed to assess the relative BA of alogliptin and pioglitazone via point estimates and 90% CI for the ratio of AUC(0-72) for Regimen A (test) versus Regimen B (reference).|LSM difference|1.0486||||0.066|TWO_SIDED|90.0|1.0051|1.0939|||ANOVA|||||1.0939|1.0051|0.066
72616243|NCT03501277|144763132|EQUIVALENCE|Pioglitazone: For each analyte, ANOVA was performed on natural logarithm transformed AUC(0-72) with factors for sequence, the participant nested within sequence, period, and regimen. For the relative BA determination, pairwise comparisons were performed to assess the relative BA of alogliptin and pioglitazone via point estimates and 90% CI for the ratio of AUC(0-72) for Regimen C (test) versus Regimen D (reference).|LSM difference|1.0267||||0.308|TWO_SIDED|90.0|0.9839|1.0714|||ANOVA|||||1.0714|0.9839|0.308
72371573|NCT00669409|144253441|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|7.98|||TWO_SIDED|95.0|-16.6|15.0||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||15.0|-16.6|
72371574|NCT00669409|144253441|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-17.1|STANDARD_ERROR_OF_MEAN|7.98|||TWO_SIDED|95.0|-32.8|-1.3||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-1.3|-32.8|
72432217|NCT03253653|144376885|OTHER||z|-0.596||||0.551|TWO_SIDED||||||Mann-Whitney U rank sum test||||We used the Mann-Whitney U rank sum test (two-tailed alpha level p \< 0.05), appropriate for between-subjects analyses, to determine whether level of the heart rate after a tobacco smoking session for n=50 smokers differed from the level for n=25 non-smokers.|||0.551
72432218|NCT03253653|144376886|OTHER||z|-0.787||||0.431|TWO_SIDED||||||Mann-Whitney U rank sum test||||We used the Mann-Whitney U rank sum test (two-tailed alpha level p \< 0.05), appropriate for between-subjects analyses, to determine whether level of the furan metabolite post a tobacco smoking session for n=50 smokers differed from the level for n=25 non-smokers.|||0.431
72371575|NCT00669409|144253441|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-5.2|STANDARD_ERROR_OF_MEAN|7.99|||TWO_SIDED|95.0|-21.0|10.6||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||10.6|-21.0|
72432219|NCT03253653|144376887|OTHER||z|-0.652||||0.515|TWO_SIDED||||||Mann-Whitney U rank sum test||||We used the Mann-Whitney U rank sum test (two-tailed alpha level p \< 0.05), appropriate for between-subjects analyses, to determine whether level of the furan metabolite post a tobacco smoking session for n=50 smokers differed from the level for n=25 non-smokers.|||0.515
72616244|NCT01860404|144763155|SUPERIORITY|||||||0.871|||||||Kruskal-Wallis|||||||0.871
72616245|NCT01860404|144763156|SUPERIORITY|||||||0.14|||||||Kruskal-Wallis|||||||0.140
72616246|NCT01860404|144763157|SUPERIORITY|||||||0.267|||||||Kruskal-Wallis|||||||0.267
72616247|NCT01860404|144763158|SUPERIORITY|||||||0.476|||||||Kruskal-Wallis|||||||0.476
72616248|NCT01860404|144763159|SUPERIORITY|||||||0.581|||||||Kruskal-Wallis|||||||0.581
72616249|NCT01860404|144763160|SUPERIORITY|||||||0.203|||||||Fisher Exact|||||||0.203
72616250|NCT01860404|144763161|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.00
72616251|NCT01860404|144763162|SUPERIORITY|||||||0.482|||||||Kruskal-Wallis|||||||0.482
72616252|NCT01860404|144763163|SUPERIORITY|||||||0.393|||||||Kruskal-Wallis|||||||0.393
72616253|NCT01860404|144763164|SUPERIORITY|||||||0.629|||||||Kruskal-Wallis|||||||0.629
72616254|NCT01860404|144763165|SUPERIORITY|||||||0.624|||||||Regression, Linear|||||||0.624
72616255|NCT01860404|144763166|SUPERIORITY|||||||0.2554|||||||Regression, Linear|||||||0.2554
72616256|NCT01860404|144763167|SUPERIORITY|||||||0.7964|||||||Regression, Linear|||||||0.7964
72616257|NCT01860404|144763168|SUPERIORITY|||||||0.7749|||||||Regression, Linear|||||||0.7749
72616258|NCT01860404|144763169|SUPERIORITY|||||||0.0036|||||||Regression, Linear|||||||0.0036
72616259|NCT01860404|144763170|SUPERIORITY|||||||0.0053|||||||Regression, Linear|||||||0.0053
72616260|NCT01860404|144763171|SUPERIORITY|||||||0.8234|||||||Regression, Linear|||||||0.8234
72616261|NCT02762604|144763172|SUPERIORITY||Mean Difference (Net)|-2.12|STANDARD_ERROR_OF_MEAN|8.79|||TWO_SIDED|95.0|-19.36|15.12|||||The estimate parameter reflects the difference in pre to post change between Imagined Gait and Visual Imagery groups.|A linear mixed effects model was used to compare changes in normal pace gait speed pre and post intervention - as a function of intervention (Imagined Gait vs. Visual Imagery)||15.12|-19.36|
72616262|NCT02762604|144763172|SUPERIORITY||Mean Difference (Net)|17.19|STANDARD_ERROR_OF_MEAN|8.05|||TWO_SIDED|95.0|1.4|32.97|||||The estimate parameter reflects the difference in pre to post change between Imagined Gait and Visual Imagery groups.|A linear mixed effects model was used to compare changes in gait speed during walking while talking pre and post intervention||32.97|1.40|
72616263|NCT02762604|144763173|SUPERIORITY||Mean Difference (Net)|1.6|STANDARD_ERROR_OF_MEAN|0.71|||TWO_SIDED|95.0|0.21|2.99|||||The estimate parameter reflects change in the number of correct letters generated pre to post intervention as a function intervention (Imagined Gait vs. Visual Imagery).|A linear mixed effects model was used to compare changes in correct letters generated pre and post intervention - as a function of intervention (Imagined Gait vs. Visual Imagery)||2.99|0.21|
72616264|NCT02762604|144763174|SUPERIORITY||Mean Difference (Net)|2.4|STANDARD_ERROR_OF_MEAN|7.37|||TWO_SIDED|95.0|-12.04|16.85|||||The estimate parameter reflects change in functional activation/deactivation pattern from pre to post intervention as a function intervention (Imagined Gait vs. Visual Imagery).|Linear mixed effects model were used to compare changes in the functional activation/deactivation pattern (factor score) during imagery of walking-while talking (relative to walking and talking alone) pre and post intervention - as a function of of intervention (Imagined Gait vs. Visual Imagery)||16.85|-12.04|
72616265|NCT02762604|144763175|SUPERIORITY||Mean Difference (Net)|-0.54|STANDARD_ERROR_OF_MEAN|6.94|||TWO_SIDED|95.0|-14.15|13.07|||||The estimate parameter is the difference in change pre to post intervention between Imagined Gait and Visual Imagery group.|Linear mixed effects model were used to compare changes in trails a time pre and post intervention - as a function of intervention (Imagined Gait vs. Visual Imagery)||13.07|-14.15|
72616266|NCT02762604|144763176|SUPERIORITY||Mean Difference (Net)|-12.21|STANDARD_ERROR_OF_MEAN|20.26|||TWO_SIDED|95.0|-51.92|27.51|||||The estimate parameter is the difference in change pre to post intervention between Imagined Gait and Visual Imagery group.|Linear mixed effects model were used to compare changes in trails b time pre and post intervention - as a function of intervention (Imagined Gait vs. Visual Imagery)||27.51|-51.92|
72616267|NCT02762604|144763177|SUPERIORITY||Mean Difference (Net)|-10.83|STANDARD_ERROR_OF_MEAN|19.03|||TWO_SIDED|95.0|-48.12|26.47|||||The estimate parameter is the difference in change pre to post intervention between Imagined Gait and Visual Imagery group.|Linear mixed effects model were used to compare changes in trails B minus A time pre and post intervention.||26.47|-48.12|
72616268|NCT02762604|144763178|SUPERIORITY||Mean Difference (Net)|-0.93|STANDARD_ERROR_OF_MEAN|0.88|||TWO_SIDED|95.0|-2.65|0.79|||||The estimate parameter reflects the difference in pre to post change between Imagined Gait and Visual Imagery groups.|A linear mixed effects model was used to compare changes in correct letter number sequences pre and post intervention - as a function of intervention (Imagined Gait vs. Visual Imagery)||0.79|-2.65|
72616269|NCT02762604|144763179|SUPERIORITY||Mean Difference (Net)|1.39|STANDARD_ERROR_OF_MEAN|12.95|||TWO_SIDED|95.0|-24.0|26.78|||||The estimate parameter reflects the difference in pre to post change between Imagined Gait and Visual Imagery groups.|A linear mixed effects model was used to compare changes in Stroop interference pre and post intervention - as a function of intervention (Imagined Gait vs. Visual Imagery)||26.78|-24.00|
72432220|NCT03253653|144376888|OTHER||z|-2.394||||0.017|TWO_SIDED||||||Mann-Whitney U rank sum test||||We used the Mann-Whitney U rank sum test (two-tailed alpha level p \< 0.05), appropriate for between-subjects analyses, to determine whether level of the furan metabolite post a tobacco smoking session for n=50 smokers differed from the level for n=25 non-smokers.|||0. 017
72432221|NCT03253653|144376889|OTHER||z|-1.286||||0.199|TWO_SIDED||||||Mann-Whitney U rank sum test||||We used the Mann-Whitney U rank sum test (two-tailed alpha level p \< 0.05), appropriate for between-subjects analyses, to determine whether level of the furan metabolite post a tobacco smoking session for n=50 smokers differed from the level for n=25 non-smokers.|||0.199
72554926|NCT03086460|144641764|SUPERIORITY||Mean Difference (Final Values)|0.167|||<|0.001|TWO_SIDED|95.0|0.109|0.225|||ANCOVA|||"Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.225|0.109|<0.001
72554927|NCT03086460|144641764|SUPERIORITY||Mean Difference (Final Values)|0.144|||<|0.001|TWO_SIDED|95.0|0.098|0.19|||ANCOVA|||"Comparison groups were:~Treatment F ( Perforomist® IS 40 μg TDD) versus Treatment E (Placebo).~The statistical analysis was performed using an analysis of covariance (ANCOVA) including treatment, period, and patient as fixed effects, and baseline as a covariate."||0.190|0.098|<0.001
72554928|NCT03086460|144641764|SUPERIORITY||Mean Difference (Final Values)|0.047||||0.059|TWO_SIDED|95.0|-0.002|0.095|||ANCOVA|||"Comparison groups were:~Treatment B (CHF 1531 pMDI 12 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~The statistical analysis was performed using an analysis of covariance (ANCOVA) including treatment, period, and patient as fixed effects, and baseline as a covariate."||0.095|-0.002|0.059
72554929|NCT03086460|144641764|SUPERIORITY||Mean Difference (Final Values)|0.022||||0.361|TWO_SIDED|95.0|-0.026|0.07|||ANCOVA|||"Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~Statistical analysis was performed as described for the statistical analysis #6 of this outcome measure."||0.070|-0.026|0.361
72554930|NCT03086460|144641764|SUPERIORITY||Mean Difference (Final Values)|0.057||||0.016|TWO_SIDED|95.0|0.011|0.102|||ANCOVA|||"Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~Statistical analysis was performed as described for the statistical analysis #6 of this outcome measure."||0.102|0.011|0.016
72554931|NCT03086460|144641764|SUPERIORITY||Mean Difference (Final Values)|-0.025||||0.34|TWO_SIDED|95.0|-0.075|0.026|||ANCOVA|||"Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment B (CHF 1531 pMDI 12 μg TDD).~Statistical analysis was performed as described for the statistical analysis #6 of this outcome measure."||0.026|-0.075|0.340
72554932|NCT03086460|144641764|SUPERIORITY||Mean Difference (Final Values)|0.01||||0.69|TWO_SIDED|95.0|-0.038|0.058|||ANCOVA|||"Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment B (CHF 1531 pMDI 12 μg TDD).~Statistical analysis was performed as described for the statistical analysis #6 of this outcome measure."||0.058|-0.038|0.690
72432222|NCT03253653|144376890|OTHER||z|-3.091||||0.002|TWO_SIDED||||||Mann-Whitney U rank sum test||||We used the Mann-Whitney U rank sum test (two-tailed alpha level p \< 0.05), appropriate for between-subjects analyses, to determine whether level of the furan metabolite post a tobacco smoking session for n=50 smokers differed from the level for n=25 non-smokers.|||0.002
72432223|NCT03253653|144376891|OTHER||z|0.13||||0.896|TWO_SIDED||||||Wilcoxon signed rank test||||We used the Wilcoxon signed rank test (two-tailed alpha level p \< 0.05), appropriate for within-subjects analyses, to determine whether level of the furan metabolite post a tobacco smoking session for n=50 smokers differed from the level pre the tobacco smoking session.|||0.896
72432224|NCT03253653|144376892|OTHER||z|-0.362||||0.717|TWO_SIDED||||||The Wilcoxon signed rank test||||We used the Wilcoxon signed rank test (two-tailed alpha level p \< 0.05), appropriate for within-subjects analyses, to determine whether level of the furan metabolite post a tobacco smoking session for n=50 smokers differed from the level pre the tobacco smoking session.|||0.717
72432225|NCT03253653|144376893|OTHER||z|2.233||||0.026|TWO_SIDED||||||Wilcoxon signed rank test||||We used the Wilcoxon signed rank test (two-tailed alpha level p \< 0.05), appropriate for within-subjects analyses, to determine whether level of the furan metabolite post a tobacco smoking session for n=50 smokers differed from the level pre the tobacco smoking session.|||0.026
72432226|NCT03253653|144376894|OTHER||z|0.383||||0.702|TWO_SIDED||||||Wilcoxon signed rank test||||We used the Wilcoxon signed rank test (two-tailed alpha level p \< 0.05), appropriate for within-subjects analyses, to determine whether level of the furan metabolite post a tobacco smoking session for n=50 smokers differed from the level pre the tobacco smoking session.|||0.702
72432227|NCT03253653|144376895|OTHER||z|2.244||||0.025|TWO_SIDED||||||Wilcoxon signed rank test||||We used the Wilcoxon signed rank test (two-tailed alpha level p \< 0.05), appropriate for within-subjects analyses, to determine whether level of the furan metabolite post a tobacco smoking session for n=50 smokers differed from the level pre the tobacco smoking session.|||0.025
72432228|NCT00886613|144376904|SUPERIORITY_OR_OTHER||kappa coefficient of agreement|0.85||||0.564|TWO_SIDED|90.0|0.72|0.99|||McNemar||The significance of the difference between the proportion of subjects with a positive skin test at 48 hours and the proportion of subjects with a positive skin test at 72 hours|||0.99|0.72|0.564
72432229|NCT00886613|144376906|SUPERIORITY_OR_OTHER||Difference in proportions|0.06||||0.343|TWO_SIDED|90.0|-0.17|0.28|||Chi-squared||Statistical analysis for dose 2|||0.28|-0.17|0.343
72432230|NCT04541186|144376911|SUPERIORITY||Median Percent Change Difference|-43.73|||<|0.001|TWO_SIDED|95.0|-57.08|-30.31||Significant level = 0.05|van Elteren test|Nonparametric analysis stratified by baseline TG level and background lipid therapy to test the treatment difference using pooled data.|The location shift and Hodges-Lehmann 95% confidence interval were based on Hodges-Lehman estimation. Placebo group is the reference group, and the comparison was performed in pooled pegozafermin treatment group vs. placebo pooled.|||-30.31|-57.08|<0.001
72432231|NCT04541186|144376912|SUPERIORITY||||||<|0.001||||||Significant level = 0.05|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by baseline TG level and lipid modifying therapy use.||||||<0.001
72616270|NCT02762604|144763180|SUPERIORITY||Mean Difference (Net)|6.76|STANDARD_ERROR_OF_MEAN|79.95|||TWO_SIDED|95.0|-149.94|163.47|||||The estimate parameter reflects the difference in pre to post change between Imagined Gait and Visual Imagery groups.|A linear mixed effects model was used to compare changes in flanker interference pre and post intervention - as a function of intervention (Imagined Gait vs. Visual Imagery)||163.47|-149.94|
72432232|NCT04541186|144376913|SUPERIORITY||Least Squares Means Difference|-17.87|STANDARD_ERROR_OF_MEAN|6.425||0.007|TWO_SIDED|95.0|-30.67|-5.07||Significant level = 0.05|MMRM|||MMRM analysis of non-HDL-C comparison between pegozafermin pooled versus placebo pooled group.||-5.07|-30.67|0.007
72432233|NCT04541186|144376913|SUPERIORITY||Least Squares Means Difference|-11.75|STANDARD_ERROR_OF_MEAN|4.888||0.019|TWO_SIDED|95.0|-21.48|-2.01||Significant level of 0.05|MMRM|||MMRM analysis of ApoB comparison between pegozafermin pooled versus placebo pooled group.||-2.01|-21.48|0.019
72432234|NCT04541186|144376913|SUPERIORITY||Least Squares Means Difference|1.73|STANDARD_ERROR_OF_MEAN|10.519||0.87|TWO_SIDED|95.0|-19.21|22.68||Significant level = 0.05|MMRM|||MMRM analysis of LDL-C comparison between pegozafermin pooled versus placebo pooled group.||22.68|-19.21|0.870
72432235|NCT04541186|144376913|SUPERIORITY||Least Squares Means Difference|15.41|STANDARD_ERROR_OF_MEAN|8.182||0.064|TWO_SIDED|95.0|-0.89|31.7||Significant level = 0.05|MMRM|||MMRM analysis of HDL-C comparison between pegozafermin pooled versus placebo pooled group.||31.70|-0.89|0.064
72432236|NCT04541186|144376914|SUPERIORITY|||||||0.006||||||Significant level = 0.05|van Elteren Test|||Nonparametric analysis of VLDL-C comparison between pegozafermin pooled versus placebo pooled group.||||0.006
72432237|NCT04541186|144376914|SUPERIORITY|||||||0.002||||||Significant level of 0.05|van Elteren test|||Nonparametric analysis of VLDL-TG comparison between pegozafermin pooled versus placebo pooled group.||||0.002
72432238|NCT04541186|144376915|SUPERIORITY|||||||0.809||||||Significant level = 0.05|MMRM|||MMRM analysis of fasting plasma glucose comparison between pegozafermin pooled versus placebo pooled group.||||0.809
72432239|NCT04541186|144376915|SUPERIORITY||||||<|0.001||||||Significant level = 0.05|MMRM|||MMRM analysis of adiponectin comparison between pegozafermin pooled versus placebo pooled group.||||<0.001
72432240|NCT04541186|144376915|SUPERIORITY|||||||0.973||||||Significant level = 0.05|MMRM|||MMRM analysis of body weight comparison between pegozafermin pooled versus placebo pooled group.||||0.973
72432241|NCT04541186|144376916|SUPERIORITY|||||||0.012||||||Significant level = 0.05|ANCOVA|||||||0.012
72432242|NCT02334306|144376942|SUPERIORITY||Mean Difference (Net)|-1.4|STANDARD_ERROR_OF_MEAN|1.3||0.262|TWO_SIDED|90.0|-3.6|0.7|||ANCOVA||Adjusted mean difference for MEDI5872 210 mg:Placebo was calculated with associated 90% confidence interval and p-value.|||0.7|-3.6|0.262
72432243|NCT02334306|144376943|SUPERIORITY||Mean Difference (Net)|0.93|STANDARD_ERROR_OF_MEAN|0.33||0.82|TWO_SIDED|90.0|0.52|1.64|||ANCOVA||Adjusted Geometric mean ratio for MEDI5872 210 mg:Placebo was calculated with associated 90% confidence interval, SE (log), and p-value.|For plasma cell levels||1.64|0.52|0.820
72432244|NCT02334306|144376943|SUPERIORITY||Median Difference (Net)|0.65|STANDARD_ERROR_OF_MEAN|0.4||0.291|TWO_SIDED|90.0|0.33|1.28|||ANCOVA||Adjusted Geometric mean ratio for MEDI5872 210 mg:Placebo was calculated with associated 90% confidence interval, SE (log), and p-value.|For TFH cells||1.28|0.33|0.291
72432245|NCT02334306|144376944|SUPERIORITY||Mean Difference (Net)|0.87|STANDARD_ERROR_OF_MEAN|0.17||0.44|TWO_SIDED|90.0|0.65|1.18|||ANCOVA||Adjusted Geometric mean ratio for MEDI5872 210 mg:Placebo was calculated with associated 90% confidence interval, SE (log), and p-value.|For total plasma cells||1.18|0.65|0.440
72432246|NCT02334306|144376944|SUPERIORITY||Median Difference (Net)|0.43|STANDARD_ERROR_OF_MEAN|0.28||0.008|TWO_SIDED|90.0|0.26|0.7|||ANCOVA||Adjusted Geometric mean ratio for MEDI5872 210 mg:Placebo was calculated with associated 90% confidence interval, SE (log), and p-value.|For CD4/ICOS TFH cells||0.70|0.26|0.008
72432247|NCT02334306|144376944|SUPERIORITY||Median Difference (Net)|1.01|STANDARD_ERROR_OF_MEAN|0.26||0.972|TWO_SIDED|90.0|0.64|1.59|||ANCOVA||Adjusted Geometric mean ratio for MEDI5872 210 mg:Placebo was calculated with associated 90% confidence interval, SE (log), and p-value.|For PD-1/ICOS TFH cells||1.59|0.64|0.972
72432248|NCT02334306|144376946|SUPERIORITY||Mean Difference (Net)|0.4|STANDARD_ERROR_OF_MEAN|0.7||0.574|TWO_SIDED|90.0|-0.8|1.6|||ANCOVA||Adjusted mean difference for MEDI5872 210 mg:Placebo was calculated with associated 90% confidence interval and p-value.|||1.6|-0.8|0.574
72432249|NCT02334306|144376947|SUPERIORITY||Difference in percentages|25.0||||0.252|TWO_SIDED|90.0|-3.1|50.9|||Fisher Exact|||ESSDAI \[3\]||50.9|-3.1|0.252
72432250|NCT02334306|144376947|SUPERIORITY||Difference in precentages|25.0||||0.252|TWO_SIDED|90.0|-3.1|50.9|||Fisher Exact|||ESSDAI\[4\]||50.9|-3.1|0.252
72432251|NCT02390557|144376966|SUPERIORITY||Mean Difference (Final Values)|10.7||||0.074|TWO_SIDED||||||Chi-squared, Corrected|||we had a prior hypothesis that the survey intervention would be associated with a larger increase in perceived quality of health care compared with control from Wave 1 to Wave 2||||0.074
72432252|NCT02390557|144376966|SUPERIORITY||Mean Difference (Final Values)|7.4||||0.069|TWO_SIDED||||||Chi-squared, Corrected|||We compared change in perception of quality of health care between Control v YES Health, wave 1 v Wave 2||||.069
72432253|NCT01813422|144376980|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-1.007|STANDARD_ERROR_OF_MEAN|0.187|<|0.0001|TWO_SIDED|95.0|-1.375|-0.64|||ANCOVA|ANCOVA model included terms for the treatment group, the geographic region stratification factor, and baseline PAV.|Treatment difference uses placebo as the reference.|||-0.640|-1.375|< 0.0001
72432254|NCT01813422|144376981|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-4.889|STANDARD_ERROR_OF_MEAN|1.201|<|0.0001|TWO_SIDED|95.0|-7.247|-2.531|||ANCOVA|ANCOVA model included terms for the treatment group, the geographic region stratification factor, and baseline TAV.|Treatment difference uses placebo as the reference.|||-2.531|-7.247|< 0.0001
72432255|NCT01813422|144376982|SUPERIORITY_OR_OTHER||Treatment Difference|17.0|||<|0.0001|TWO_SIDED|95.0|10.3|23.5|||Cochran-Mantel-Haenszel|Based on CMH test stratified by geographic region.|Treatment difference uses placebo as the reference.|||23.5|10.3|< 0.0001
72432256|NCT01813422|144376983|SUPERIORITY_OR_OTHER||Treatment Difference|12.5||||0.0002|TWO_SIDED|95.0|5.8|19.1|||Cochran-Mantel-Haenszel|Based on CMH test stratified by geographic region.|Treatment difference uses placebo as the reference.|||19.1|5.8|0.0002
72432257|NCT04889118|144376992|SUPERIORITY|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate.|Hazard Ratio (HR)|0.55||||0.0013|TWO_SIDED|95.0|0.37|0.81||One-sided p-value based on log-rank test.|Log Rank||HR=Pembrolizumab + Lenvatinib vs. Pembrolizumab + Placebo|||0.81|0.37|0.0013
72432258|NCT04889118|144376993|SUPERIORITY|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate|Hazard Ratio (HR)|0.93||||0.3728|TWO_SIDED|95.0|0.58|1.48||One-sided p-value based on log-rank test|Log Rank||HR=Pembrolizumab + Lenvatinib vs. Pembrolizumab + Placebo|||1.48|0.58|0.3728
72432259|NCT03124108|144377028|SUPERIORITY||Difference in percentage|-52.0|STANDARD_ERROR_OF_MEAN|5.4|<|0.001|TWO_SIDED|95.0|-62.5|-41.5|||ANCOVA|||||-41.5|-62.5|<0.001
72432260|NCT03124108|144377028|SUPERIORITY||Difference in percentage|-43.9|STANDARD_ERROR_OF_MEAN|6.0|<|0.001|TWO_SIDED|95.0|-55.7|-32.1|||ANCOVA|||||-32.1|-55.7|<0.001
72432261|NCT03643965|144377071|OTHER|Ratio of UPCR at 9 months compared to baseline for Nefecon compared to Placebo|Ratio of geometric LS means|0.73||||0.0003|TWO_SIDED|96.0|0.61|0.88|||MMRM model|||||0.88|0.61|0.0003
72432262|NCT03643965|144377072|OTHER|Time-weighted average of eGFR, Nefecon compared to Placebo|Ratio of geometric LS means|1.1|||<|0.0001|TWO_SIDED|95.0|1.06|1.15|||robust regression|||||1.15|1.06|<0.0001
72432263|NCT03643965|144377073|OTHER|Ratio of eGFR at 9 months comparison of Nefecon to Placebo|Ratio of geometric LS means|1.07||||0.0014|TWO_SIDED|95.0|1.03|1.13|||robust regression|||||1.13|1.03|0.0014
72432264|NCT03643965|144377074|OTHER|Ratio of eGFR at 12 months comparison of Nefecon to Placebo|Ratio of geometric LS means|1.07||||0.0106|TWO_SIDED|95.0|1.01|1.13|||robust regression|||||1.13|1.01|0.0106
72432265|NCT03643965|144377075|OTHER|Ratio of UACR at 9 months comparison of Nefecon to Placebo|Ratio of geometric LS means|0.69||||0.0005|TWO_SIDED|95.0|0.55|0.86|||MMRM model|||||0.86|0.55|0.0005
72432266|NCT03643965|144377076|OTHER|Time to 30% reduction in eGFR comparison Nefecon to Placebo|Hazard Ratio (HR)|0.45||||0.0028|TWO_SIDED|95.0|0.26|0.75|||Cox proportional hazards model|Cox proportional hazards model with individual patient censoring weighting.||||0.75|0.26|0.0028
72432267|NCT03643965|144377077|OTHER|Time to receiving rescue medication comparison Nefecon to Placebo|Hazard Ratio (HR)|0.68||||0.2647|TWO_SIDED|95.0|0.34|1.33|||Cox proportional hazards model|||||1.33|0.34|0.2647
72432268|NCT03643965|144377078|OTHER|Ratio of UPCR compared to baseline averaged over time points between 12 and 24 months, comparison Nefecon vs Placebo|Ratio of geometric LS means|0.59|||<|0.0001|TWO_SIDED|95.0|0.51|0.68|||MMRM model|||||0.68|0.51|<0.0001
72432269|NCT03643965|144377079|OTHER|Ratio of UACR compared to baseline averaged over time points between 12 and 24 months, Nefecon vs Placebo|Ratio of geometric LS means|0.54|||<|0.0001|TWO_SIDED|95.0|0.45|0.63|||MMRM model|||||0.63|0.45|<0.0001
72432270|NCT03643965|144377080|OTHER|Ratio of eGFR compared to baseline averaged over time points between 12 and 24 months, comparison Nefecon vs Placebo|Ratio of geometric LS means|1.11|||<|0.0001|TWO_SIDED|95.0|1.06|1.16|||robust regression|||||1.16|1.06|<0.0001
72432271|NCT03643965|144377081|OTHER|Proportion of patients without microhematuria, comparison Nefecon vs Placebo|Odds Ratio (OR)|2.5||||0.0001|TWO_SIDED|95.0|1.6|4.1|||Regression, Logistic|||||4.1|1.6|0.0001
72432272|NCT02820051|144377084|SUPERIORITY|||||||0.281||||||threshold for statistical significance: \< 0.05|Wilcoxon (Mann-Whitney)|||The sample was calculated with alpha 0.05, beta 0.20, standard deviation of 7.3,8 minimum PtcCO2 difference to detect of 5 mmHg, loss to follow-up estimated 0.20, and two-tails. According to the above, the sample size was 42 patients per group.|We tested normal distribution with the Kolmogorov-Smirnov test. Data are shown as means and standard deviations for variables with normal distribution and as medians and interquartile ranges for non-normal variables. We used the t-test, the Mann-Whitney U-test, ANOVA, or chi-square as indicated. We defined a statistically significant difference as a P value \< 0.05. The analysis was performed using SPSS version 18.0 for Windows (SPSS Inc., Chicago, IL).|||0.281
72432273|NCT02820051|144377085|SUPERIORITY|We used the t-test, the Mann-Whitney U-test, ANOVA, or chi-square as indicated. We defined a statistically significant difference as a P value \< 0.05.|||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
72432274|NCT02820051|144377086|SUPERIORITY|T test|||||<|0.05|||||||t-test, 2 sided|||||||<0.05
72432275|NCT01222247|144377087|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.8||||0.02|TWO_SIDED|95.0|0.66|0.97|||Chi-squared|||Analysis for Primary Outcome composite||0.97|0.66|0.02
72432276|NCT01222247|144377087|SUPERIORITY||Risk Ratio (RR)|0.77||||0.01|TWO_SIDED|95.0|0.63|0.95|||Chi-squared|||Analysis for CPAP or high-flow nasal cannula||0.95|0.63|0.01
72432277|NCT01222247|144377087|SUPERIORITY||Risk Ratio (RR)|0.77||||0.17|TWO_SIDED|95.0|0.53|1.12|||Chi-squared|||Analysis for Fraction of inspired oxygen||1.12|0.53|0.17
72432278|NCT01222247|144377087|SUPERIORITY||Risk Ratio (RR)|0.78||||0.26|TWO_SIDED|95.0|0.5|1.21|||Chi-squared|||Analysis for mechanical ventilation||1.21|0.50|0.26
72432279|NCT01222247|144377088|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.67|||<|0.001|TWO_SIDED|95.0|0.53|0.84|||Chi-squared|||||0.84|0.53|<0.001
72432280|NCT01222247|144377089|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.78||||0.003|TWO_SIDED|95.0|0.66|0.92|||Chi-squared|||||0.92|0.66|0.003
72432281|NCT01222247|144377090|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.87||||0.36|TWO_SIDED|95.0|0.65|1.17|||Chi-squared|||||1.17|0.65|0.36
72432282|NCT01222247|144377091|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.68||||0.002|TWO_SIDED|95.0|0.53|0.87|||Chi-squared|||||0.87|0.53|0.002
72432283|NCT01222247|144377092|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.88||||0.57|TWO_SIDED|95.0|0.55|1.39|||Chi-squared|||||1.39|0.55|0.57
72432284|NCT01222247|144377093|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.22||||0.04|TWO_SIDED|95.0|0.02|0.92|||Chi-squared|||||0.92|0.02|0.04
72432285|NCT01222247|144377094|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.45||||0.1|TWO_SIDED|95.0|0.17|1.19|||Chi-squared|||||1.19|0.17|0.10
72432286|NCT01222247|144377095|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.59||||0.03|TWO_SIDED|95.0|0.37|0.96|||Chi-squared|||||0.96|0.37|0.03
72432287|NCT01222247|144377096|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.78||||0.004|TWO_SIDED|95.0|0.66|0.93|||Chi-squared|||||0.93|0.66|0.004
72432288|NCT01222247|144377097|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.82||||0.74|TWO_SIDED|95.0|0.25|2.68|||Chi-squared|||||2.68|0.25|0.74
72432289|NCT01222247|144377098|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5|||||||Chi-squared|||||||0.50
72616271|NCT02762604|144763181|SUPERIORITY||Mean Difference (Net)|15.2|STANDARD_ERROR_OF_MEAN|4.7|||TWO_SIDED|95.0|5.99|24.41|||||The estimate parameter reflects the difference in pre to post change between Imagined Gait and Visual Imagery groups.|A linear mixed effects model was used to compare changes in stride length during walking while talking pre and post intervention - as a function of intervention (Imagined Gait vs. Visual Imagery)||24.41|5.99|
72432290|NCT01222247|144377099|SUPERIORITY_OR_OTHER_LEGACY|||||||0.32|||||||Wilcoxon (Mann-Whitney)|||||||0.32
72432291|NCT01222247|144377100|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|1.14||||0.13|TWO_SIDED|95.0|0.96|1.34|||Chi-squared|||||1.34|0.96|0.13
72432292|NCT01222247|144377101|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1|||||||Chi-squared|||||||0.10
72432293|NCT01222247|144377103|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.8||||0.62|TWO_SIDED|95.0|0.33|1.93|||Chi-squared|||||1.93|0.33|0.62
72432294|NCT01222247|144377105|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.88||||0.4|TWO_SIDED|95.0|0.66|1.18|||Chi-squared|||||1.18|0.66|0.40
72554933|NCT03086460|144641764|SUPERIORITY||Mean Difference (Final Values)|0.034||||0.155|TWO_SIDED|95.0|-0.013|0.082|||ANCOVA|||"Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment C (CHF 1531 pMDI 24 μg TDD).~Statistical analysis was performed as described for the statistical analysis #6 of this outcome measure."||0.082|-0.013|0.155
72554934|NCT03086460|144641765|SUPERIORITY||Mean Difference (Final Values)|0.112|||<|0.001|TWO_SIDED|95.0|0.049|0.175|||ANCOVA|||"Comparison groups:~Treatment A (CHF 1531 pMDI 6 μg TDD) versus Treatment E (Placebo).~Analysis of covariance model: treatment, subject, and period as fixed effects; baseline FEV1 value as covariates. CIs and p-values for CHF 1531 pMDI vs Placebo are adjusted for multiplicity (parametric simulation method by Edwards and Berry). Subjects receiving the same treatment in more than one period are included in the primary efficacy model with only data from the first instance of each treatment."||0.175|0.049|<0.001
72554935|NCT03086460|144641765|SUPERIORITY||Mean Difference (Final Values)|0.166|||<|0.001|TWO_SIDED|95.0|0.101|0.23|||ANCOVA|||"Comparison groups were:~Treatment B (CHF 1531 pMDI 12 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.230|0.101|<0.001
72554936|NCT03086460|144641765|SUPERIORITY||Mean Difference (Final Values)|0.138|||<|0.001|TWO_SIDED|95.0|0.074|0.203|||ANCOVA|||"Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.203|0.074|<0.001
72554937|NCT03086460|144641765|SUPERIORITY||Mean Difference (Final Values)|0.174|||<|0.001|TWO_SIDED|95.0|0.113|0.235|||ANCOVA|||"Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.235|0.113|<0.001
72554938|NCT03086460|144641765|SUPERIORITY||Mean Difference (Final Values)|0.149|||<|0.001|TWO_SIDED|95.0|0.101|0.197|||ANCOVA|||"Comparison groups were:~Treatment F ( Perforomist® IS 40 μg TDD) versus Treatment E (Placebo).~Analysis of covariance model: treatment, subject, and period as fixed effects; baseline FEV1 value as covariates. Subjects receiving the same treatment in more than one period are included in the primary efficacy model with only data from the first instance of each treatment."||0.197|0.101|<0.001
72554939|NCT03086460|144641765|SUPERIORITY||Mean Difference (Final Values)|0.054||||0.035|TWO_SIDED|95.0|0.004|0.104|||ANCOVA|||"Comparison groups were:~Treatment B (CHF 1531 pMDI 12 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~Analysis of covariance model: treatment, subject, and period as fixed effects; baseline FEV1 value as covariates. Subjects receiving the same treatment in more than one period are included in the primary efficacy model with only data from the first instance of each treatment."||0.104|0.004|0.035
72554940|NCT03086460|144641765|SUPERIORITY||Mean Difference (Final Values)|0.026||||0.301|TWO_SIDED|95.0|-0.024|0.076|||ANCOVA|||"Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~Statistical analysis was performed as described for the statistical analysis #6 of this outcome measure."||0.076|-0.024|0.301
72554941|NCT03086460|144641765|SUPERIORITY||Mean Difference (Final Values)|0.062||||0.011|TWO_SIDED|95.0|0.014|0.11|||ANCOVA|||"Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~Statistical analysis was performed as described for the statistical analysis #6 of this outcome measure."||0.110|0.014|0.011
72554942|NCT03086460|144641765|SUPERIORITY||Mean Difference (Final Values)|-0.028||||0.294|TWO_SIDED|95.0|-0.08|0.024|||ANCOVA|||"Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment B (CHF 1531 pMDI 12 μg TDD).~Statistical analysis was performed as described for the statistical analysis #6 of this outcome measure."||0.024|-0.080|0.294
72432295|NCT01222247|144377106|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|1.6|||<|0.001|TWO_SIDED|95.0|1.37|1.87|||Chi-squared|||||1.87|1.37|<0.001
72432296|NCT01222247|144377107|SUPERIORITY_OR_OTHER_LEGACY|||||||0.004|||||||Wilcoxon (Mann-Whitney)|||||||0.004
72432297|NCT01222247|144377108|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.93||||0.4|TWO_SIDED|95.0|0.78|1.1|||Chi-squared|||||1.10|0.78|0.40
72432298|NCT01222247|144377109|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|1.17||||0.15|TWO_SIDED|95.0|0.95|1.4|||Chi-squared|||||1.40|0.95|0.15
72432299|NCT01222247|144377110|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|1.16||||0.24|TWO_SIDED|95.0|0.91|1.47|||Chi-squared|||||1.47|0.91|0.24
72432300|NCT01222247|144377111|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.93||||0.09|TWO_SIDED|95.0|0.85|1.01|||Chi-squared|||Analysis for NICU stay of any duration||1.01|0.85|0.09
72432301|NCT01222247|144377111|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.89||||0.03|TWO_SIDED|95.0|0.8|0.98|||Chi-squared|||Analysis for duration greater than or equal to 3 days||0.98|0.80|0.03
72432302|NCT01222247|144377112|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2|||||||Wilcoxon (Mann-Whitney)|||||||0.20
72432303|NCT01222247|144377113|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.61||||0.08|TWO_SIDED|95.0|0.35|1.07|||Chi-squared|||Statistical analysis for chorioamnionitis||1.07|0.35|0.08
72432304|NCT01222247|144377113|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.98||||0.96|TWO_SIDED|95.0|0.49|1.95|||Chi-squared|||Analysis for Postpartum Endometritis||1.95|0.49|0.96
72432305|NCT01222247|144377113|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|1.03||||0.56|TWO_SIDED|95.0|0.93|1.15|||Chi-squared|||Statistical analysis for cesarean delivery||1.15|0.93|0.56
72616272|NCT02762604|144763182|SUPERIORITY||Mean Difference (Net)|-1.96|STANDARD_ERROR_OF_MEAN|0.9|||TWO_SIDED|95.0|-3.73|-0.2|||||The estimate parameter reflects the difference in pre to post change between Imagined Gait and Visual Imagery groups.|A linear mixed effects model was used to compare changes in gait variability during walking while talking pre and post intervention - as a function of intervention (Imagined Gait vs. Visual Imagery)||-0.20|-3.73|
72554943|NCT03086460|144641765|SUPERIORITY||Mean Difference (Final Values)|0.008||||0.747|TWO_SIDED|95.0|-0.042|0.058|||ANCOVA|||"Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment B (CHF 1531 pMDI 12 μg TDD).~Statistical analysis was performed as described for the statistical analysis #6 of this outcome measure."||0.058|-0.042|0.747
72554944|NCT03086460|144641765|SUPERIORITY||Mean Difference (Final Values)|0.036||||0.155|TWO_SIDED|95.0|-0.014|0.086|||ANCOVA|||"Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment C (CHF 1531 pMDI 24 μg TDD).~Statistical analysis was performed as described for the statistical analysis #6 of this outcome measure."||0.086|-0.014|0.155
72554945|NCT03086460|144641766|SUPERIORITY||Mean Difference (Final Values)|0.136|||<|0.001|TWO_SIDED|95.0|0.065|0.207|||ANCOVA|||"Treatment A (CHF 1531 pMDI 6 μg TDD) versus Treatment E (Placebo).~Analysis of covariance model: treatment, subject, and period as fixed effects; baseline FEV1 value as covariates. CIs and p-values for CHF 1531 pMDI vs Placebo are adjusted for multiplicity (parametric simulation method by Edwards and Berry). Subjects receiving the same treatment in more than one period are included in the model with only data for the instance of each treatment, which occurred after the randomization error."||0.207|0.065|<0.001
72554946|NCT03086460|144641766|SUPERIORITY||Mean Difference (Final Values)|0.186|||<|0.001|TWO_SIDED|95.0|0.113|0.258|||ANCOVA|||"Comparison groups were:~Treatment B (CHF 1531 pMDI 12 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.258|0.113|<0.001
72554947|NCT03086460|144641766|SUPERIORITY||Mean Difference (Final Values)|0.165|||<|0.001|TWO_SIDED|95.0|0.092|0.238|||ANCOVA|||"Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.238|0.092|<0.001
72554948|NCT03086460|144641766|SUPERIORITY||Mean Difference (Final Values)|0.185|||<|0.001|TWO_SIDED|95.0|0.118|0.252|||ANCOVA|||"Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.252|0.118|<0.001
72554949|NCT03086460|144641766|SUPERIORITY||Mean Difference (Final Values)|0.176|||<|0.001|TWO_SIDED|95.0|0.121|0.231|||ANCOVA|||"Comparison groups were:~Treatment F ( Perforomist® IS 40 μg TDD) versus Treatment E (Placebo).~Analysis of covariance model: treatment, subject, and period as fixed effects; baseline FEV1 value as covariates. Subjects receiving the same treatment in more than one period are included in the model with only data for the instance of each treatment which occurred after the randomization error."||0.231|0.121|<0.001
72554950|NCT03086460|144641766|SUPERIORITY||Mean Difference (Final Values)|0.05||||0.088|TWO_SIDED|95.0|-0.008|0.108|||ANCOVA|||"Comparison groups were:~Treatment B (CHF 1531 pMDI 12 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~Analysis of covariance model: treatment, subject, and period as fixed effects; baseline FEV1 value as covariates. Subjects receiving the same treatment in more than one period are included in the model with only data for the instance of each treatment which occurred after the randomization error."||0.108|-0.008|0.088
72554951|NCT03086460|144641766|SUPERIORITY||Mean Difference (Final Values)|0.029||||0.323|TWO_SIDED|95.0|-0.029|0.088|||ANCOVA|||"Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~Statistical analysis was performed as described for the statistical analysis #6 of this outcome measure."||0.088|-0.029|0.323
72554952|NCT03086460|144641766|SUPERIORITY||Mean Difference (Final Values)|0.049||||0.073|TWO_SIDED|95.0|-0.005|0.103|||ANCOVA|||"Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~Statistical analysis was performed as described for the statistical analysis #6 of this outcome measure."||0.103|-0.005|0.073
72554953|NCT03086460|144641766|SUPERIORITY||Mean Difference (Final Values)|-0.021||||0.489|TWO_SIDED|95.0|-0.08|0.039|||ANCOVA|||"Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment B (CHF 1531 pMDI 12 μg TDD).~Statistical analysis was performed as described for the statistical analysis #6 of this outcome measure."||0.039|-0.080|0.489
72554954|NCT03086460|144641766|SUPERIORITY||Median Difference (Final Values)|-0.001||||0.978|TWO_SIDED|95.0|-0.057|0.056|||ANCOVA|||"Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment B (CHF 1531 pMDI 12 μg TDD).~Statistical analysis was performed as described for the statistical analysis #6 of this outcome measure."||0.056|-0.057|0.978
72554955|NCT03086460|144641766|SUPERIORITY||Mean Difference (Final Values)|0.02||||0.484|TWO_SIDED|95.0|-0.037|0.077|||ANCOVA|||"Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment C (CHF 1531 pMDI 24 μg TDD).~Statistical analysis was performed as described for the statistical analysis #6 of this outcome measure."||0.077|-0.037|0.484
72554956|NCT03086460|144641767|SUPERIORITY||Mean Difference (Final Values)|0.107|||<|0.001|TWO_SIDED|95.0|0.048|0.166|||ANCOVA|||"Comparison groups:~Treatment A (CHF 1531 pMDI 6 μg TDD) versus Treatment E (Placebo).~Analysis of covariance model: treatment and period as fixed effects, subject as random effect, baseline FEV1 value as covariate. CIs and p-values for CHF 1531 pMDI vs Placebo are adjusted for multiplicity (parametric simulation method by Edwards and Berry). Patients receiving the same treatment during two periods are considered twice in the ANCOVA model (once for each period attended)."||0.166|0.048|<0.001
72432306|NCT01222247|144377114|SUPERIORITY_OR_OTHER_LEGACY|||||||0.57|||||||Wilcoxon (Mann-Whitney)|||Analysis for interval from randomization to delivery||||0.57
72432307|NCT01222247|144377115|SUPERIORITY|||||||0.11|||||||Wilcoxon (Mann-Whitney)|||||||0.11
72432308|NCT04939428|144377122|SUPERIORITY||Confidence Interval|-2.0|||=|0.0848|TWO_SIDED|95.0|-5.0|0.9|||Miettinen & Nurminen method|||Adjusted differences and the corresponding confidence intervals are based on Miettinen \& Nurminen method stratified by age and household size.||0.9|-5|= 0.0848
72432309|NCT04939428|144377123|OTHER|Estimated differences and confidence intervals are provided.|Confidence Interval|-1.4|||||TWO_SIDED|95.0|-4.8|2.0|||Miettinen & Nurminen method|||95% CIs (Tier 2 endpoints) was provided for between treatment differences in the percentage of participants with events; these analyses was performed using the Miettinen and Nurminen method.||2.0|-4.8|
72432310|NCT04939428|144377124|OTHER|Estimated differences and confidence intervals are provided|Confidence Interval|0.3|||||TWO_SIDED|95.0|-0.4|1.0|||Miettinen & Nurminen method.|||95% CIs (Tier 2 endpoints) was provided for between treatment differences in the percentage of participants with events; these analyses was performed using the Miettinen and Nurminen method.||1.0|-0.4|
72432311|NCT04939428|144377125|SUPERIORITY||Confidence Interval|-3.2|||=|0.0205|TWO_SIDED|95.0|-6.3|-0.1|||Miettinen & Nurminen method|||Adjusted differences and the corresponding confidence intervals are based on Miettinen \& Nurminen method stratified by age and household size.||-0.1|-6.3|= 0.0205
72432312|NCT04939428|144377126|OTHER|Adjusted differences and the corresponding confidence intervals.|Confidence Interval|-2.2|||||TWO_SIDED|95.0|-5.4|1.0|||Miettinen & Nurminen method|||Adjusted differences and the corresponding confidence intervals are based on Miettinen \& Nurminen method stratified by age and household size.||1.0|-5.4|
72432313|NCT04939428|144377127|OTHER|Adjusted differences and the corresponding confidence intervals|Confidence Interval|-3.0|||||TWO_SIDED|95.0|-6.9|0.8||||||Adjusted differences and the corresponding confidence intervals are based on Miettinen \& Nurminen method stratified by age and household size.||0.8|-6.9|
72432314|NCT04939428|144377128|OTHER|Adjusted differences and the corresponding confidence intervals.|Mean Difference (Final Values)|-10.5|||||TWO_SIDED|95.0|-22.7|2.0|||Miettinen & Nurminen method|||Adjusted differences and the corresponding confidence intervals are based on Miettinen \& Nurminen method stratified by age and household size.||2.0|-22.7|
72432315|NCT05302791|144377138|SUPERIORITY|||||||0.609|||||||ANOVA|time x condition ANOVA||||||.609
72432316|NCT05302791|144377139|SUPERIORITY|||||||0.858|||||||ANOVA|time x condition anova||||||.858
72432317|NCT05302791|144377140|SUPERIORITY|||||||0.633|||||||ANOVA|||||||.633
72432318|NCT05302791|144377141|SUPERIORITY|||||||0.076|||||||ANOVA|||||||.076
72432319|NCT05302791|144377142|SUPERIORITY|||||||0.151|||||||ANOVA|||||||.151
72432320|NCT05302791|144377143|SUPERIORITY|||||||0.385|||||||ANOVA|||||||.385
72432321|NCT05302791|144377144|SUPERIORITY|||||||0.665|||||||ANOVA|||||||.665
72432322|NCT05302791|144377145|SUPERIORITY|||||||0.078|||||||ANOVA|||||||.078
72432323|NCT05302791|144377146|SUPERIORITY|||||||0.773|||||||ANOVA|||||||.773
72432324|NCT05302791|144377147|SUPERIORITY|||||||0.118|||||||ANOVA|||||||.118
72432325|NCT05302791|144377148|SUPERIORITY||||||<|0.001|||||||ANOVA|Time x condition ANOVA||||||<0.001
72432326|NCT05302791|144377149|SUPERIORITY||||||<|0.001|||||||ANOVA|time x condition anova||||||<0.001
72432327|NCT02696785|144377159|SUPERIORITY||Odds Ratio (OR)|2.73||||0.005|TWO_SIDED|95.0|1.35|5.52|||Regression, Logistic|||Overall Work Impairment Score||5.52|1.35|0.005
72432328|NCT02696785|144377159|SUPERIORITY||Odds Ratio (OR)|4.45|||<|0.001|TWO_SIDED|95.0|2.2|9.03|||Regression, Logistic|||Overall Work Impairment Score.||9.03|2.20|<0.001
72432329|NCT02696785|144377159|SUPERIORITY||Odds Ratio (OR)|5.09|||<|0.001|TWO_SIDED|95.0|2.52|10.28|||Regression, Logistic|||Overall Work Impairment Score.||10.28|2.52|<0.001
72432330|NCT02696785|144377159|SUPERIORITY||LSMean Difference|-7.0|STANDARD_ERROR_OF_MEAN|3.16|<|0.001|TWO_SIDED|95.0|-13.2|-0.7|||ANCOVA|||Percentage of Activity Impairment||-0.7|-13.2|<0.001
72432331|NCT02696785|144377159|SUPERIORITY||LSMean Difference|-9.3|STANDARD_ERROR_OF_MEAN|3.19|<|0.001|TWO_SIDED|95.0|-15.5|-3.0|||ANCOVA|||Percentage of Activity Impairment||-3.0|-15.5|<0.001
72432332|NCT02696785|144377159|SUPERIORITY||LSMean Difference|-8.9|STANDARD_ERROR_OF_MEAN|3.22|<|0.001|TWO_SIDED|95.0|-15.2|-2.5|||ANCOVA|||Percentage of Activity Impairment||-2.5|-15.2|<0.001
72432333|NCT02696785|144377160|SUPERIORITY||Odds Ratio (OR)|2.3||||0.007|TWO_SIDED|95.0|1.25|4.23|||Regression, Logistic|||||4.23|1.25|0.007
72432334|NCT02696785|144377160|SUPERIORITY||Odds Ratio (OR)|2.78||||0.001|TWO_SIDED|95.0|1.48|5.24|||Regression, Logistic|||||5.24|1.48|0.001
72432335|NCT02696785|144377160|SUPERIORITY||Odds Ratio (OR)|3.39|||<|0.001|TWO_SIDED|95.0|1.79|6.41|||Regression, Logistic|||||6.41|1.79|<0.001
72432336|NCT02696785|144377161|SUPERIORITY||LSMean Difference|-0.84|STANDARD_ERROR_OF_MEAN|0.137|<|0.001|TWO_SIDED|95.0|-1.11|-0.57|||Mixed Models Analysis|||||-0.57|-1.11|<0.001
72432337|NCT02696785|144377161|SUPERIORITY||LSMean Difference|-0.97|STANDARD_ERROR_OF_MEAN|0.141|<|0.001|TWO_SIDED|95.0|-1.25|-0.7|||Mixed Models Analysis|||||-0.70|-1.25|<0.001
72432338|NCT02696785|144377161|SUPERIORITY||LSMean Difference|-0.91|STANDARD_ERROR_OF_MEAN|0.14|<|0.001|TWO_SIDED|95.0|-1.18|-0.63|||Mixed Models Analysis|||||-0.63|-1.18|<0.001
72432339|NCT02696785|144377162|SUPERIORITY||Odds Ratio (OR)|2.53||||0.012|TWO_SIDED|95.0|1.23|5.21|||Regression, Logistic|||||5.21|1.23|0.012
72432340|NCT02696785|144377162|SUPERIORITY||Odds Ratio (OR)|3.74|||<|0.001|TWO_SIDED|95.0|1.82|7.7|||Regression, Logistic|||||7.70|1.82|<0.001
72432341|NCT02696785|144377162|SUPERIORITY||Odds Ratio (OR)|3.9|||<|0.001|TWO_SIDED|95.0|1.91|7.98|||Regression, Logistic|||||7.98|1.91|<0.001
72432342|NCT02696785|144377163|SUPERIORITY||LSMean Difference|-0.97|STANDARD_ERROR_OF_MEAN|0.299||0.001|TWO_SIDED|95.0|-1.56|-0.39|||Mixed Models Analysis|||||-0.39|-1.56|0.001
72432343|NCT02696785|144377163|SUPERIORITY||LSMean Difference|-1.22|STANDARD_ERROR_OF_MEAN|0.307|<|0.001|TWO_SIDED|95.0|-1.83|-0.62|||Mixed Models Analysis|||||-0.62|-1.83|<0.001
72432344|NCT02696785|144377163|SUPERIORITY||LSMean Difference|-1.27|STANDARD_ERROR_OF_MEAN|0.304|<|0.001|TWO_SIDED|95.0|-1.86|-0.67|||Mixed Models Analysis|||||-0.67|-1.86|<0.001
72432345|NCT02696785|144377164|SUPERIORITY||LSMean Difference|7.62||||0.009|TWO_SIDED|95.0|1.67|34.68|||Regression, Logistic|||||34.68|1.67|0.009
72432346|NCT02696785|144377164|SUPERIORITY||Odds Ratio (OR)|8.03||||0.007|TWO_SIDED|95.0|1.75|36.83|||Regression, Logistic|||||36.83|1.75|0.007
72432347|NCT02696785|144377164|SUPERIORITY||Odds Ratio (OR)|5.13||||0.041|TWO_SIDED|95.0|1.07|24.49|||Regression, Logistic|||||24.49|1.07|0.041
72432348|NCT02696785|144377165|SUPERIORITY||LSMean Difference|-2.78|STANDARD_ERROR_OF_MEAN|0.447|<|0.001|TWO_SIDED|95.0|-3.7|-1.9|||ANCOVA|||||-1.9|-3.7|<0.001
72432349|NCT02696785|144377165|SUPERIORITY||LSMean Difference|-2.62|STANDARD_ERROR_OF_MEAN|0.45|<|0.001|TWO_SIDED|95.0|-3.5|-1.7|||ANCOVA|||||-1.7|-3.5|<0.001
72432350|NCT02696785|144377165|SUPERIORITY||LSMean Difference|-2.39|STANDARD_ERROR_OF_MEAN|0.452|<|0.001|TWO_SIDED|95.0|-3.3|-1.5|||ANCOVA|||||-1.5|-3.3|<0.001
72432351|NCT02696785|144377166|SUPERIORITY||LSMean Difference|3.2574|STANDARD_ERROR_OF_MEAN|1.0437||0.002|TWO_SIDED|95.0|1.2041|5.3106|||Mixed Models Analysis|||PCS||5.3106|1.2041|0.002
72432352|NCT02696785|144377166|SUPERIORITY||LSMean Difference|4.052|STANDARD_ERROR_OF_MEAN|1.072|<|0.001|TWO_SIDED|95.0|1.9432|6.1608|||Mixed Models Analysis|||PCS||6.1608|1.9432|<0.001
72432353|NCT02696785|144377166|SUPERIORITY||LSMean Difference|4.3254|STANDARD_ERROR_OF_MEAN|1.0641|<|0.001|TWO_SIDED|95.0|2.2321|6.4186|||Mixed Models Analysis|||PCS||6.4186|2.2321|<0.001
72432354|NCT02696785|144377166|SUPERIORITY||LSMean Difference|0.4321|STANDARD_ERROR_OF_MEAN|1.1718||0.713|TWO_SIDED|95.0|-1.8732|2.7373|||Mixed Models Analysis|||MCS||2.7373|-1.8732|0.713
72432355|NCT02696785|144377166|SUPERIORITY||LSMean Difference|0.6273|STANDARD_ERROR_OF_MEAN|1.2028||0.602|TWO_SIDED|95.0|-1.7387|2.9934|||Mixed Models Analysis|||MCS||2.9934|-1.7387|0.602
72432356|NCT02696785|144377166|SUPERIORITY||LSMean Difference|0.4467|STANDARD_ERROR_OF_MEAN|1.1978||0.709|TWO_SIDED|95.0|-1.9097|2.803|||Mixed Models Analysis|||MCS||2.8030|-1.9097|0.709
72432357|NCT02696785|144377167|SUPERIORITY||LSMean Difference|-1.05|STANDARD_ERROR_OF_MEAN|0.416||0.012|TWO_SIDED|95.0|-1.87|-0.23|||Mixed Models Analysis|||||-0.23|-1.87|0.012
72432358|NCT02696785|144377167|SUPERIORITY||LSMean Difference|-1.11|STANDARD_ERROR_OF_MEAN|0.428||0.01|TWO_SIDED|95.0|-1.95|-0.27|||Mixed Models Analysis|||||-0.27|-1.95|0.010
72432359|NCT02696785|144377167|SUPERIORITY||LSMean Difference|-1.49|STANDARD_ERROR_OF_MEAN|0.423|<|0.001|TWO_SIDED|95.0|-2.32|-0.66|||Mixed Models Analysis|||||-0.66|-2.32|<0.001
72432360|NCT02696785|144377168|SUPERIORITY||LSMean Difference|-8.628|STANDARD_ERROR_OF_MEAN|2.6724||0.001|TWO_SIDED|95.0|-13.885|-3.371|||Mixed Models Analysis|||||-3.371|-13.885|0.001
72493468|NCT01327157|144516030|EQUIVALENCE|The comparison among the groups, from the results obtained by the Visual Analog Scale (VAS), was done through analysis of variance models (ANOVA) with two factors.|Mean Difference (Net)|0.5||||0.524|TWO_SIDED|||||Statistical significance was considered for values of p \<0.05 and it was used The Minitab statistical software, version 15.1 to obtain the results.|t-test, 1 sided|The comparison between the groups in each study period (initial) was done through the t-test for two independent samples.||"We assessed the quality of oral functions in the first query to check the status of discomfort before treatment in both groups, using VAS..~Statistical significance was considered for values of p \<0.05 and it was used The Minitab statistical software, version 15.1 to obtain the results"||||0.524
72493469|NCT01327157|144516031|EQUIVALENCE|"Only the treatment group was analysed. The dental contacts were evaluated in models and gnathostats demarcated after the points were counted in the models before and after treatment If an increase in the number of dental contacts after occlusal adjustment was detected, in relation of the models.~The models are made in the first and last query, after four visits with one month interval between them."|Mean Difference (Net)|5.0|STANDARD_DEVIATION|3.92|<|0.001|TWO_SIDED||||||t-test, 2 sided|||The brand carbon mark was done on the treatment group in the first and last query.||||<0.001
72493470|NCT01327157|144516032|EQUIVALENCE|The comparison among the groups, from the results obtained by the Visual Analog Scale (VAS), was done through analysis of variance models (ANOVA) with two factors. The comparison among the groups, in each period of the study (initial and final) was done through t test for two independent samples.|Mean Difference (Net)|2.4|STANDARD_DEVIATION|1.44||0.002|TWO_SIDED||||||t-test, 2 sided|||"We assessed the quality of oral functions in the last query to check the status of discomfort after ninety days in both groups, control and treatment, using VAS.~The statistical significance was considered to p\<0.05 values and it was used the Minitab statistics software, 15.1 version, to get the results."||||0.002
72493471|NCT01327157|144516033|OTHER|||||||0.705|||||||t-test, 1 sided|||||||0.705
72493472|NCT01327157|144516034|OTHER|||||||0.01|||||||t-test, 1 sided|||||||0.01
72432361|NCT02696785|144377168|SUPERIORITY||LSMean Difference|-6.635|STANDARD_ERROR_OF_MEAN|2.7438||0.016|TWO_SIDED|95.0|-12.033|-1.238|||Mixed Models Analysis|||||-1.238|-12.033|0.016
72432362|NCT02696785|144377168|SUPERIORITY||LSMean Difference|-7.991|STANDARD_ERROR_OF_MEAN|2.7248||0.004|TWO_SIDED|95.0|-13.351|-2.631|||Mixed Models Analysis|||||-2.631|-13.351|0.004
72432363|NCT02696785|144377169|SUPERIORITY||LSMean Difference|-0.367|STANDARD_ERROR_OF_MEAN|0.1143||0.001|TWO_SIDED|95.0|-0.592|-0.142|||Mixed Models Analysis|||||-0.142|-0.592|0.001
72432364|NCT02696785|144377169|SUPERIORITY||LSMean Difference|-0.422|STANDARD_ERROR_OF_MEAN|0.1184|<|0.001|TWO_SIDED|95.0|-0.655|-0.189|||Mixed Models Analysis|||||-0.189|-0.655|<0.001
72432365|NCT02696785|144377169|SUPERIORITY||LSMean Difference|-0.329|STANDARD_ERROR_OF_MEAN|0.1167||0.005|TWO_SIDED|95.0|-0.558|-0.099|||Mixed Models Analysis|||||-0.099|-0.558|0.005
72432366|NCT02696785|144377170|SUPERIORITY||LSMean Difference|0.63|STANDARD_ERROR_OF_MEAN|0.211||0.003|TWO_SIDED|95.0|0.22|1.05|||Mixed Models Analysis|||||1.05|0.22|0.003
72432367|NCT02696785|144377170|SUPERIORITY||LSMean Difference|0.43|STANDARD_ERROR_OF_MEAN|0.219||0.051|TWO_SIDED|95.0|0.0|0.86|||Mixed Models Analysis|||||0.86|-0.00|0.051
72432368|NCT02696785|144377170|SUPERIORITY||LSMean Difference|0.6|STANDARD_ERROR_OF_MEAN|0.215||0.005|TWO_SIDED|95.0|0.18|1.03|||Mixed Models Analysis|||||1.03|0.18|0.005
72432369|NCT02696785|144377171|SUPERIORITY||LSMean Difference|-0.67|STANDARD_ERROR_OF_MEAN|0.321||0.039|TWO_SIDED|95.0|-1.3|-0.03|||Mixed Models Analysis|||||-0.03|-1.30|0.039
72432370|NCT02696785|144377171|SUPERIORITY||LSMean Difference|-0.63|STANDARD_ERROR_OF_MEAN|0.33||0.057|TWO_SIDED|95.0|-1.28|0.02|||Mixed Models Analysis|||||0.02|-1.28|0.057
72493473|NCT01564862|144516045|SUPERIORITY_OR_OTHER||LS mean difference|1.75|STANDARD_ERROR_OF_MEAN|0.744||0.019|TWO_SIDED|95.0|0.28|3.21||P-value was from an ANCOVA model with treatment and center as fixed factors and the baseline value as a covariate.|ANCOVA|||||3.21|0.28|0.019
72493474|NCT01564862|144516045|SUPERIORITY_OR_OTHER||LS mean difference|1.21|STANDARD_ERROR_OF_MEAN|0.733||0.099|TWO_SIDED|95.0|-0.23|2.65||P-value was from an ANCOVA model with treatment and center as fixed factors and the baseline value as a covariate.|ANCOVA|||||2.65|-0.23|0.099
72493475|NCT01564862|144516045|SUPERIORITY_OR_OTHER||LS mean difference|0.54|STANDARD_ERROR_OF_MEAN|0.725||0.46|TWO_SIDED|95.0|-0.89|1.96||P-value was from an ANCOVA model with treatment and center as fixed factors and the baseline value as a covariate.|ANCOVA|||||1.96|-0.89|0.460
72493476|NCT01564862|144516046|SUPERIORITY_OR_OTHER||LS Mean difference|-2.6|STANDARD_ERROR_OF_MEAN|0.78||0.001|TWO_SIDED|95.0|-4.1|-1.0||P-value was from a MMRM model with baseline\*week, center, week, treatment and week\*treatment as factors in the analysis.|Mixed Models Analysis|||||-1.0|-4.1|0.001
72554957|NCT03086460|144641767|SUPERIORITY||Mean Difference (Final Values)|0.157|||<|0.001|TWO_SIDED|95.0|0.096|0.217|||ANCOVA|||"Comparison groups were:~Treatment B (CHF 1531 pMDI 12 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.217|0.096|<0.001
72554958|NCT03086460|144641767|SUPERIORITY||Mean Difference (Final Values)|0.133|||<|0.001|TWO_SIDED|95.0|0.073|0.193|||ANCOVA|||"Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.193|0.073|<0.001
72554959|NCT03086460|144641767|SUPERIORITY||Mean Difference (Final Values)|0.16|||<|0.001|TWO_SIDED|95.0|0.103|0.217|||ANCOVA|||"Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.217|0.103|<0.001
72554960|NCT03086460|144641767|SUPERIORITY||Mean Difference (Final Values)|0.147|||<|0.001|TWO_SIDED|95.0|0.102|0.192|||ANCOVA|||"Comparison groups were:~Treatment F ( Perforomist® IS 40 μg TDD) versus Treatment E (Placebo).~Analysis of covariance model: treatment and period as fixed effects, subject as random effect, baseline FEV1 value as covariate. Patients receiving the same treatment during two periods are considered twice in the ANCOVA model (once for each period attended)."||0.192|0.102|<0.001
72554961|NCT03086460|144641767|SUPERIORITY||Mean Difference (Final Values)|0.05||||0.041|TWO_SIDED|95.0|0.002|0.098|||ANCOVA|||"Comparison groups were:~Treatment B (CHF 1531 pMDI 12 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~Analysis of covariance model: treatment and period as fixed effects, subject as random effect, baseline FEV1 value as covariate. Patients receiving the same treatment during two periods are considered twice in the ANCOVA model (once for each period attended)."||0.098|0.002|0.041
72554962|NCT03086460|144641767|SUPERIORITY||Mean Difference (Final Values)|0.026||||0.275|TWO_SIDED|95.0|-0.021|0.073|||ANCOVA|||"Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~Statistical analysis was performed as described for the statistical analysis #6 of this outcome measure."||0.073|-0.021|0.275
72554963|NCT03086460|144641767|SUPERIORITY||Mean Difference (Final Values)|0.053||||0.021|TWO_SIDED|95.0|0.008|0.098|||ANCOVA|||"Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~Statistical analysis was performed as described for the statistical analysis #6 of this outcome measure."||0.098|0.008|0.021
72554964|NCT03086460|144641767|SUPERIORITY||Mean Difference (Final Values)|-0.024||||0.35|TWO_SIDED|95.0|-0.073|0.026|||ANCOVA|||"Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment B (CHF 1531 pMDI 12 μg TDD).~Statistical analysis was performed as described for the statistical analysis #6 of this outcome measure."||0.026|-0.073|0.350
72554965|NCT03086460|144641767|SUPERIORITY||Mean Difference (Final Values)|0.003||||0.886|TWO_SIDED|95.0|-0.044|0.051|||ANCOVA|||"Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment B (CHF 1531 pMDI 12 μg TDD).~Statistical analysis was performed as described for the statistical analysis #6 of this outcome measure."||0.051|-0.044|0.886
72554966|NCT03086460|144641767|SUPERIORITY||Mean Difference (Final Values)|0.027||||0.254|TWO_SIDED|95.0|-0.02|0.074|||ANCOVA|||"Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment C (CHF 1531 pMDI 24 μg TDD).~Statistical analysis was performed as described for the statistical analysis #6 of this outcome measure."||0.074|-0.020|0.254
72554967|NCT03086460|144641768|SUPERIORITY||Mean Difference (Final Values)|0.114|||<|0.001|TWO_SIDED|95.0|0.06|0.169|||ANCOVA|||"Comparison groups were:~Treatment A (CHF 1531 pMDI 6 μg TDD) versus Treatment E (Placebo).~This secondary efficacy variable was analyzed using the ANCOVA model that was also used for the primary efficacy analysis, without adjusting for multiplicity."||0.169|0.060|<0.001
72554968|NCT03086460|144641768|SUPERIORITY||Mean Difference (Final Values)|0.154|||<|0.001|TWO_SIDED|95.0|0.099|0.208|||ANCOVA|||"Comparison groups were:~Treatment B (CHF 1531 pMDI 12 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.208|0.099|<0.001
72554969|NCT03086460|144641768|SUPERIORITY||Mean Difference (Final Values)|0.193|||<|0.001|TWO_SIDED|95.0|0.138|0.247|||ANCOVA|||"Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.247|0.138|<0.001
72554970|NCT03086460|144641768|SUPERIORITY||Mean Difference (Final Values)|0.216|||<|0.001|TWO_SIDED|95.0|0.163|0.268|||ANCOVA|||"Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.268|0.163|<0.001
72554971|NCT03086460|144641768|SUPERIORITY||Mean Difference (Final Values)|0.172|||<|0.001|TWO_SIDED|95.0|0.12|0.224|||ANCOVA|||"Comparison groups were:~Treatment F ( Perforomist® IS 40 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.224|0.120|<0.001
72554972|NCT03086460|144641768|SUPERIORITY||Mean Difference (Final Values)|0.04||||0.165|TWO_SIDED|95.0|-0.016|0.095|||ANCOVA|||"Comparison groups were:~Treatment B (CHF 1531 pMDI 12 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.095|-0.016|0.165
72554973|NCT03086460|144641768|SUPERIORITY||Mean Difference (Final Values)|0.078||||0.005|TWO_SIDED|95.0|0.024|0.132|||ANCOVA|||"Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.132|0.024|0.005
72554974|NCT03086460|144641768|SUPERIORITY||Mean Difference (Final Values)|0.101|||<|0.001|TWO_SIDED|95.0|0.049|0.153|||ANCOVA|||"Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.153|0.049|<0.001
72432371|NCT02696785|144377171|SUPERIORITY||LSMean Difference|-0.67|STANDARD_ERROR_OF_MEAN|0.327||0.042|TWO_SIDED|95.0|-1.31|-0.03|||Mixed Models Analysis|||||-0.03|-1.31|0.042
72554975|NCT03086460|144641768|SUPERIORITY||Mean Difference (Final Values)|0.039||||0.187|TWO_SIDED|95.0|-0.019|0.097|||ANCOVA|||"Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment B (CHF 1531 pMDI 12 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.097|-0.019|0.187
72554976|NCT03086460|144641768|SUPERIORITY||Mean Difference (Final Values)|0.062||||0.028|TWO_SIDED|95.0|0.007|0.116|||ANCOVA|||"Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment B (CHF 1531 pMDI 12 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.116|0.007|0.028
72554977|NCT03086460|144641768|SUPERIORITY||Mean Difference (Final Values)|0.023||||0.406|TWO_SIDED|95.0|-0.031|0.076|||ANCOVA|||"Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment C (CHF 1531 pMDI 24 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.076|-0.031|0.406
72554978|NCT03086460|144641769|SUPERIORITY||Mean Difference (Final Values)|0.173|||<|0.001|TWO_SIDED|95.0|0.116|0.23|||ANCOVA|||"Day 1~Comparison groups were:~Treatment A (CHF 1531 pMDI 6 μg TDD) versus Treatment E (Placebo).~This secondary efficacy variable was analyzed using the ANCOVA model that was also used for the primary efficacy analysis, without adjusting for multiplicity."||0.230|0.116|<0.001
72554979|NCT03086460|144641769|SUPERIORITY||Mean Difference (Final Values)|0.203|||<|0.001|TWO_SIDED|95.0|0.146|0.26|||ANCOVA|||"Day 1~Comparison groups were:~Treatment B (CHF 1531 pMDI 12 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.260|0.146|<0.001
72554980|NCT03086460|144641769|SUPERIORITY||Mean Difference (Final Values)|0.223|||<|0.001|TWO_SIDED|95.0|0.166|0.28|||ANCOVA|||"Day 1~Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.280|0.166|<0.001
72554981|NCT03086460|144641769|SUPERIORITY||Mean Difference (Final Values)|0.27|||<|0.001|TWO_SIDED|95.0|0.216|0.325|||ANCOVA|||"Day 1~Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.325|0.216|<0.001
72554982|NCT03086460|144641769|SUPERIORITY||Mean Difference (Final Values)|0.241|||<|0.001|TWO_SIDED|95.0|0.187|0.295|||ANCOVA|||"Day 1~Comparison groups were:~Treatment F ( Perforomist® IS 40 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.295|0.187|<0.001
72554983|NCT03086460|144641769|SUPERIORITY||Mean Difference (Final Values)|0.03||||0.308|TWO_SIDED|95.0|-0.028|0.089|||ANCOVA|||"Day 1~Comparison groups were:~Treatment B (CHF 1531 pMDI 12 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.089|-0.028|0.308
72616273|NCT02762604|144763184|SUPERIORITY||Mean Difference (Net)|2.43|STANDARD_ERROR_OF_MEAN|4.29|||TWO_SIDED|95.0|-5.98|10.84|||||The estimate parameter reflects the difference in pre to post change between Imagined Gait and Visual Imagery groups.|A linear mixed effects model was used to compare changes in total free recall pre and post intervention - as a function of intervention (Imagined Gait vs. Visual Imagery)||10.84|-5.98|
72616274|NCT02762604|144763185|SUPERIORITY||Mean Difference (Net)|-1.94|STANDARD_ERROR_OF_MEAN|2.01|||TWO_SIDED|95.0|-5.88|2.0|||||The estimate parameter reflects the difference in pre to post change between Imagined Gait and Visual Imagery groups.|A linear mixed effects model was used to compare changes in delayed figure copy recall pre and post intervention - as a function of intervention (Imagined Gait vs. Visual Imagery)||2.00|-5.88|
72616275|NCT02762604|144763186|SUPERIORITY||Mean Difference (Net)|-6.36|STANDARD_ERROR_OF_MEAN|6.96|||TWO_SIDED|95.0|-20.01|7.28|||||The estimate parameter reflects the difference in pre to post change between Imagined Gait and Visual Imagery groups.|A linear mixed effects model was used to compare changes in word fluency pre and post intervention - as a function of intervention (Imagined Gait vs. Visual Imagery)||7.28|-20.01|
72616276|NCT02762604|144763187|SUPERIORITY||Mean Difference (Net)|5.73|STANDARD_ERROR_OF_MEAN|6.25|||TWO_SIDED|95.0|-6.51|17.97|||||The estimate parameter reflects the difference in pre to post change between Imagined Gait and Visual Imagery groups.|A linear mixed effects model was used to compare changes in semantic fluency pre and post intervention - as a function of intervention (Imagined Gait vs. Visual Imagery)||17.97|-6.51|
72616277|NCT02762604|144763188|SUPERIORITY||Mean Difference (Net)|-0.03|STANDARD_ERROR_OF_MEAN|8.2|||TWO_SIDED|95.0|-16.1|16.03||||||A linear mixed effects model was used to compare changes in digit symbol substitution performance pre and post intervention - as a function of intervention (Imagined Gait vs. Visual Imagery)|The estimate parameter reflects the difference in pre to post change between Imagined Gait and Visual Imagery groups.|16.03|-16.10|
72616278|NCT02762604|144763190|SUPERIORITY||Mean Difference (Net)|3.64|STANDARD_ERROR_OF_MEAN|7.54|||TWO_SIDED|95.0|-11.14|18.42|||||The estimate parameter reflects the difference in pre to post change between Imagined Gait and Visual Imagery groups.|A linear mixed effects model was used to compare changes in immediate maze performance pre and post intervention - as a function of intervention (Imagined Gait vs. Visual Imagery)||18.42|-11.14|
72432372|NCT02696785|144377172|SUPERIORITY||LSMean Difference|-5.13|STANDARD_ERROR_OF_MEAN|0.806|<|0.001|TWO_SIDED|95.0|-6.7|-3.5|||ANCOVA|||||-3.5|-6.7|<0.001
72616279|NCT02762604|144763191|SUPERIORITY||Mean Difference (Net)|3.26|STANDARD_ERROR_OF_MEAN|12.2|||TWO_SIDED|95.0|-20.65|27.18|||||The estimate parameter reflects the difference in pre to post change between Imagined Gait and Visual Imagery groups.|A linear mixed effects model was used to compare changes in delayed maze performance pre and post intervention - as a function of intervention (Imagined Gait vs. Visual Imagery)||27.18|-20.65|
72616280|NCT02762604|144763192|SUPERIORITY||Mean Difference (Net)|0.22|STANDARD_ERROR_OF_MEAN|0.34|||TWO_SIDED|95.0|-0.45|0.9|||||The estimate parameter reflects the difference in pre to post change between Imagined Gait and Visual Imagery groups.|A linear mixed effects model was used to compare changes in maze errors pre and post intervention - as a function of intervention (Imagined Gait vs. Visual Imagery)||0.90|-0.45|
72616281|NCT02762604|144763193|SUPERIORITY||Mean Difference (Net)|0.26|STANDARD_ERROR_OF_MEAN|1.02|||TWO_SIDED|95.0|-1.74|2.26|||||The estimate parameter reflects the difference in pre to post change between Imagined Gait and Visual Imagery groups.|A linear mixed effects model was used to compare changes in depressive symptoms pre and post intervention - as a function of intervention (Imagined Gait vs. Visual Imagery)||2.26|-1.74|
72616282|NCT02762604|144763194|SUPERIORITY||Mean Difference (Net)|-0.95|STANDARD_ERROR_OF_MEAN|1.24|||TWO_SIDED|95.0|-3.38|1.49|||||The estimate parameter reflects the difference in pre to post change between Imagined Gait and Visual Imagery groups.|A linear mixed effects model was used to compare changes in anxiety symptoms pre and post intervention - as a function of intervention (Imagined Gait vs. Visual Imagery)||1.49|-3.38|
72616283|NCT02762604|144763195|SUPERIORITY||Mean Difference (Net)|0.04|STANDARD_ERROR_OF_MEAN|0.04|||TWO_SIDED|95.0|-0.04|0.12|||||The estimate parameter reflects the difference in pre to post change between Imagined Gait and Visual Imagery groups.|A linear mixed effects model was used to compare changes in cortical thickness pre and post intervention - as a function of intervention (Imagined Gait vs. Visual Imagery)||0.12|-0.04|
72616284|NCT06038643|144763198|OTHER||||||<|0.001||||||Adjusted for multiple comparisons using False Discovery Rate.|Wilcoxon (Mann-Whitney)|||||||<0.001
72616285|NCT06038643|144763201|SUPERIORITY||||||<|0.01|||||||ANCOVA|||We conducted one-way analyses of covariance (ANCOVAs) to assess the effect of group (intervention vs. control) on post-intervention secondary outcomes, including cognition (Test My Brain Digital Neuropsychology Toolkit). Covariates in all models included age, sex, years of education, APOE4 status, and baseline scores.||||<0.01
72616286|NCT00762177|144763213|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
72616287|NCT00762177|144763214|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
72616288|NCT00762177|144763215|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
72616289|NCT00762177|144763216|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
72616290|NCT00762177|144763217|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
72616291|NCT00762177|144763218|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
72616292|NCT00762177|144763219|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
72616293|NCT00762177|144763220|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||the tongue will be scrapped 5 times with the edge of a tongue depressor. The depressor is vortex in sterile phosphate buffered saline(PBS) and the sample is then sonicated using a Branson 450A sonicator with a cup horn for 30 seconds. Samples diluted (10 fold) in PBS and plated using a spiral systems autoplate 4000 spiral plater on CFAT Agar||||0.05
72616294|NCT00762177|144763221|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
72616295|NCT00762177|144763222|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
72616296|NCT00762177|144763223|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
72616297|NCT00762177|144763224|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
72432373|NCT02696785|144377172|SUPERIORITY||LSMean Difference|-4.89|STANDARD_ERROR_OF_MEAN|0.812|<|0.001|TWO_SIDED|95.0|-6.5|-3.3|||ANCOVA|||||-3.3|-6.5|<0.001
72616298|NCT00762177|144763225|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
72616299|NCT00762177|144763226|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
72616300|NCT00762177|144763227|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
72616301|NCT00762177|144763228|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
72616302|NCT00762177|144763229|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
72616303|NCT00762177|144763230|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
72616304|NCT00762177|144763231|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
72616305|NCT00762177|144763232|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
72616306|NCT00762177|144763233|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
72616307|NCT00762177|144763234|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
72616308|NCT00762177|144763235|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
72616309|NCT00762177|144763236|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
72616310|NCT05259033|144763268|SUPERIORITY|Responses were analysed using an analysis of covariance (ANCOVA) model with region and randomised treatment as fixed factors and baseline HbA1c as covariate. Each imputed dataset is analysed separately and estimates are combined using Rubin's rules.|Estimated treatment difference|-0.44|||<|0.0001|TWO_SIDED|95.0|-0.56|-0.33|||ANCOVA|||Treatment policy strategy||-0.33|-0.56|<0.0001
72616311|NCT01405911|144763279|OTHER||Difference in Least Squares Means|-7.11|||<|0.001|TWO_SIDED|95.0|-9.85|-4.36|||Constrained Longitudinal Data Analysis|||||-4.36|-9.85|<0.001
72616312|NCT01405911|144763279|OTHER||Difference in Least Squares Means|-9.08|||<|0.001|TWO_SIDED|95.0|-11.82|-6.33|||Constrained Longitudinal Data Analysis|||||-6.33|-11.82|<0.001
72616313|NCT01405911|144763279|OTHER||Difference in Least Squares Means|-1.97||||0.143|TWO_SIDED|95.0|-4.61|0.67|||Constrained Longitudinal Data Analysis|||||0.67|-4.61|0.143
72616314|NCT01405911|144763280|OTHER||Difference in Least Squares Means|-17.7|||<|0.001|TWO_SIDED|95.0|-21.55|-13.86|||Constrained Longitudinal Data Analysis|||||-13.86|-21.55|<0.001
72616315|NCT01405911|144763280|OTHER||Difference in Least Squares Means|-16.41|||<|0.001|TWO_SIDED|95.0|-20.32|-12.5|||Constrained Longitudinal Data Analysis|||||-12.50|-20.32|<0.001
72616316|NCT01405911|144763280|OTHER||Difference in Least Squares Means|1.3||||0.469|TWO_SIDED|95.0|-2.22|4.82|||Constrained Longitudinal Data Analysis|||||4.82|-2.22|0.469
72616317|NCT05762744|144763288|OTHER|Unpaired two-tailed t-test to test null hypothesis||||||0.37||||||The t-test was conducted on the logarithms of the variable.|t-test, 2 sided|||Null hypothesis: the order of FSIGTs (saline or exenatide-stimulated) does not affect the response during an FSIGT||||0.37
72616318|NCT05762744|144763289|OTHER|Two-tailed unpaired t-test to test null hypothesis||||||0.66|||||||t-test, 2 sided|||Null hypothesis: The order of FSIGT (exenatide-stimulated or saline) does not affect the response to an FSIGT.||||0.66
72616319|NCT05762744|144763290|OTHER|Two-tailed unpaired t-test to test null hypothesis||||||0.55|||||||t-test, 2 sided|||Null hypothesis: the order of testing (exenatide-stimulated or saline FSIGT) does not affect data obtained in the FSIGTs.||||0.55
72616320|NCT05762744|144763291|OTHER|Unpaired, two-tailed t-test to test the null hypothesis||||||0.45|||||||t-test, 2 sided|||The order of FSIGTs (exenatide-stimulated or saline) does not affect the response during an FSIGT||||0.45
72616321|NCT05762744|144763292|OTHER|Two-tailed unpaired t-test to test null hypothesis||||||0.86||||||The t-test was conducted on the logarithms of the variable|t-test, 2 sided|||Null hypothesis: the order of FSIGT (exenatide or saline) does not affect the response during an FSIGT||||0.86
72616322|NCT05762744|144763293|OTHER|Two-tailed p-test for unpaired data||||||0.44||||||The t-test was conducted on the logarithms of the variable.|t-test, 2 sided|||Null hypothesis: The order of FSIGTs (exenatide-stimulated or saline) does not affect the response to an FSIGT||||0.44
72616323|NCT05762744|144763294|OTHER|||||||0.41|||||||t-test, 2 sided|||"Null hypothesis: no differences between the two groups with respect to exenatide's effect on first-phase insulin secretion.~t-test conducted on logarithms of the values"||||0.41
72616324|NCT05762744|144763294|OTHER|||||||0.38|||||||t-test, 2 sided|||Null hypothesis: no difference between two groups with respect to exenatide's effect on first phase insulin secretion||||0.38
72616325|NCT05762744|144763295|OTHER|||||||0.8|||||||t-test, 2 sided|||Null hypothesis: the two genotype groups do not differ with respect to the effect of exenatide on the rate of glucose disappearance||||0.80
72616326|NCT05762744|144763295|OTHER|||||||0.98|||||||t-test, 2 sided|||Null hypothesis: the two genotype groups do not differ with respect to the effect of exenatide on the rate of glucose disappearance during an FSIGT||||0.98
72616327|NCT01560416|144763316|SUPERIORITY|||||||0.79|||||||Log Rank|||||||0.79
72616328|NCT01560416|144763318|SUPERIORITY|||||||0.68|||||||Fisher Exact|||||||0.68
72616329|NCT03738215|144763330|SUPERIORITY||Least Squares Mean Difference|-2.5||||0.005|TWO_SIDED|95.0|-4.17|-0.89||Adjusted P-Value (based on truncated Hochberg with parameter=0.9)|MMRM|MMRM = mixed-effects model for repeated measures||||-0.89|-4.17|0.0050
72616330|NCT03738215|144763330|SUPERIORITY||Least Squares Mean Difference|-1.5||||0.0727|TWO_SIDED|95.0|-3.16|0.12||Adjusted P-Value (based on truncated Hochberg with parameter=0.9)|MMRM|MMRM = mixed-effects model for repeated measures||||0.12|-3.16|0.0727
72616331|NCT03738215|144763331|SUPERIORITY||Lease Squares Mean Difference|-0.3||||0.0727|TWO_SIDED|95.0|-0.49|-0.07||Adjusted P-Value (based on Hochberg procedure)|MMRM|MMRM = mixed-effects model for repeated measures||||-0.07|-0.49|0.0727
72616332|NCT03738215|144763331|SUPERIORITY||Least Squares Mean Difference|-0.2||||0.0944|TWO_SIDED|95.0|-0.39|0.03||Adjusted P-Value (based on Hochberg procedure)|MMRM|MMRM = mixed-effects model for repeated measures.||||0.03|-0.39|0.0944
72616333|NCT03277274|144763348|OTHER|TAK-954 (Total): An analysis of variance (ANOVA) were performed on log transformed Cmax (total TAK-954) to compare each hepatically impaired group with the normal hepatic function group.||||||0.579|||||||ANOVA|||||||0.579
72616334|NCT03277274|144763348|OTHER|TAK-954 (Total): An ANOVA were performed on log transformed Cmax (total TAK-954) to compare each hepatically impaired group with the normal hepatic function group.||||||0.026|||||||ANOVA|||||||0.026
72616335|NCT03277274|144763348|OTHER|TAK-954 (Free): An ANOVA were performed on log transformed Cmax (Free TAK-954) to compare each hepatically impaired group with the normal hepatic function group.||||||0.02|||||||ANOVA|||||||0.020
72616336|NCT03277274|144763348|OTHER|TAK-954 (Free): An ANOVA were performed on log transformed Cmax (Free TAK-954) to compare each hepatically impaired group with the normal hepatic function group.||||||0.031|||||||ANOVA|||||||0.031
72616337|NCT03277274|144763349|OTHER|TAK-954 (Total): An ANOVA were performed on log transformed AUClast (Total TAK-954) to compare each hepatically impaired group with the normal hepatic function group.||||||0.151|||||||ANOVA|||||||0.151
72616338|NCT03277274|144763349|OTHER|TAK-954 (Total): An ANOVA were performed on log transformed AUClast (Total TAK-954) to compare each hepatically impaired group with the normal hepatic function group.||||||0.017|||||||ANOVA|||||||0.017
72616339|NCT03277274|144763349|OTHER|TAK-954 (Free): An ANOVA were performed on log transformed AUClast (Free TAK-954) to compare each hepatically impaired group with the normal hepatic function group.||||||0.129|||||||ANOVA|||||||0.129
72616340|NCT03277274|144763349|OTHER|TAK-954 (Free): An ANOVA were performed on log transformed AUClast (Free TAK-954) to compare each hepatically impaired group with the normal hepatic function group.||||||0.023|||||||ANOVA|||||||0.023
72616341|NCT03277274|144763350|OTHER|TAK-954 (Total): An ANOVA were performed on log transformed AUCinf (Total TAK-954) to compare each hepatically impaired group with the normal hepatic function group.||||||0.138|||||||ANOVA|||||||0.138
72493477|NCT01564862|144516046|SUPERIORITY_OR_OTHER||LS mean difference|-3.0|STANDARD_ERROR_OF_MEAN|0.77|<|0.001|TWO_SIDED|95.0|-4.5|-1.5||P-value was from a MMRM model with baseline\*week, center, week, treatment and week\*treatment as factors in the analysis.|Mixed Models Analysis|||||-1.5|-4.5|<0.001
72493478|NCT01564862|144516047|SUPERIORITY_OR_OTHER||LS Mean difference|-0.29|STANDARD_ERROR_OF_MEAN|0.1211||0.017|TWO_SIDED|95.0|-0.528|-0.052||P-value was from a MMRM model with baseline\*week, center, week, treatment and week\*treatment as factors in the analysis.|Mixed Models Analysis|||||-0.052|-0.528|0.017
72493479|NCT01564862|144516047|SUPERIORITY_OR_OTHER||LS mean difference|-0.404|STANDARD_ERROR_OF_MEAN|0.1194|<|0.001|TWO_SIDED|95.0|-0.638|-0.169||P-value was from a MMRM model with baseline\*week, center, week, treatment and week\*treatment as factors in the analysis.|Mixed Models Analysis|||||-0.169|-0.638|<0.001
72493480|NCT04526665|144516060|OTHER||Odds Ratio (OR)|37.562|||<|0.0001|TWO_SIDED|95.0|7.641|302.247|||Exact Cochran-Mantel-Haenszel test|Exact Cochran-Mantel-Haenszel test stratified by the randomization factors (ALP \>3xULN or TB\>ULN:Yes/No, and Baseline PBC Worst Itch NRS ≥ 4: Yes/No)||||302.247|7.641|<0.0001
72493481|NCT04526665|144516062|OTHER||Least square mean difference|-0.784||||0.197|TWO_SIDED|95.0|-1.986|0.418|||mixed model for repeated measures (MMRM)|||||0.418|-1.986|0.1970
72493482|NCT04526665|144516063|OTHER||Least square mean difference|-0.343||||0.5522|TWO_SIDED|95.0|-1.489|0.803|||MMRM|MMRM with treatment, 4-week period and treatment by 4-week period interaction as fixed factors and adjusting for baseline and stratification factors.||||0.803|-1.489|0.5522
72493483|NCT03269344|144516180|SUPERIORITY|||||||0.11|||||||ANOVA|||||||0.11
72493484|NCT03269344|144516181|SUPERIORITY|||||||0.08|||||||Wilcoxon (Mann-Whitney)|||||||0.08
72493485|NCT03269344|144516182|SUPERIORITY|||||||0.32|||||||Wilcoxon (Mann-Whitney)|||||||0.32
72493486|NCT03269344|144516183|SUPERIORITY||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||||||<0.01
72493487|NCT03269344|144516184|SUPERIORITY|||||||0.81|||||||Wilcoxon (Mann-Whitney)|||||||0.81
72493488|NCT03269344|144516185|SUPERIORITY||||||<|0.01|||||||Chi-squared|||||||<0.01
72493489|NCT02597855|144516188|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Fisher Exact|||The difference of polyp regression rate between two groups were compared.||||<0.05
72432374|NCT02696785|144377172|SUPERIORITY||LSMean Difference|-5.17|STANDARD_ERROR_OF_MEAN|0.816|<|0.001|TWO_SIDED|95.0|-6.8|-3.6|||ANCOVA|||||-3.6|-6.8|<0.001
72493490|NCT02597855|144516189|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|The Mann-Whitney test was used for a comparison of best corrected visual acuity assessed at baseline, 3 months, and 6 months between type1 and type2.||best corrected visual acuity was compared between two groups||||<0.05
72493491|NCT02469090|144516211|SUPERIORITY||LS mean differnce|-7.6|STANDARD_ERROR_OF_MEAN|1.96||0.0002|TWO_SIDED|95.0|-11.5|-3.7||The null-hypothesis to be tested was: H0: APL-130277 is the same as placebo in its effect on the motor function against the 2-sided alternative: H1: Either of the treatment groups is superior to the other in its effect on the motor function.|LS mean difference|To control the family-wise type I error rate, the primary and secondary end points were tested in hierarchical order in the order presented||Mixed effects model for repeated measures (MMRM) was used to estimate the treatment difference(APL-130277-placebo) Observed change from pre-dose MDS-UPDRS Part III score values after 30 minutes were response values. Treatment group, visit and the interaction between the treatment group and visit were fixed factors. Change from pre-dose in MDS-UPDRS Part III score after 30 minutes at the last TV at which the randomized dose was given up through TV6 was used as a covariate||-3.7|-11.5|0.0002
72493492|NCT02469090|144516212|SUPERIORITY||Adjusted odds ratio|2.81||||0.0426|TWO_SIDED|95.0|1.036|7.644|||Adjusted Odds Ratio|||"This was analyzed using a generalized linear mixed model (with logit link function) for binomial data. The model included the observed outcomes as the response values, with treatment group, visit, and the interaction between treatment group and visit as fixed factors and the ON/OFF assessment at the last open-label titration visit at which the randomized dose was given as a covariate."||7.644|1.036|0.0426
72504439|NCT03726671|144539458|OTHER|||||||0.2995|||||||Mixed Models Analysis|The model evaluates effects from SNP, diet and SNP x diet interaction. Due to crossover design, period and sequence effects were adjusted in the model||Diet x SNP interaction effect on Phosphatidylcholine IER in Post-Menopausal Females||||0.2995
72504440|NCT03726671|144539458|OTHER|||||||0.0003|||||||Mixed Models Analysis|The model evaluates effects from SNP, diet and SNP x diet interaction. Due to crossover design, period and sequence effects were adjusted in the model||Diet x SNP interaction effect on Phosphatidylcholine IER in Males||||0.0003
72504441|NCT03726671|144539458|OTHER|||||||0.1303|||||||Mixed Models Analysis|The model evaluates effects from SNP, diet and SNP x diet interaction. Due to crossover design, period and sequence effects were adjusted in the model||SNP effect on Betaine IER in Pre-Menopausal Females||||0.1303
72504442|NCT03726671|144539458|OTHER|||||||0.0015|||||||Mixed Models Analysis|The model evaluates effects from SNP, diet and SNP x diet interaction. Due to crossover design, period and sequence effects were adjusted in the model||SNP effect on Betaine IER in Post-Menopausal Females||||0.0015
72504443|NCT03726671|144539458|OTHER|||||||0.4185|||||||Mixed Models Analysis|The model evaluates effects from SNP, diet and SNP x diet interaction. Due to crossover design, period and sequence effects were adjusted in the model||SNP effect on Betaine IER in Males||||0.4185
72504444|NCT03726671|144539458|OTHER|||||||0.3464|||||||Mixed Models Analysis|The model evaluates effects from SNP, diet and SNP x diet interaction. Due to crossover design, period and sequence effects were adjusted in the model||SNP effect on Choline IER in Pre-Menopausal Females||||0.3464
72504445|NCT03726671|144539458|OTHER|||||||0.0019|||||||Mixed Models Analysis|The model evaluates effects from SNP, diet and SNP x diet interaction. Due to crossover design, period and sequence effects were adjusted in the model||SNP effect on Choline IER in Post-Menopausal Females||||0.0019
72504446|NCT03726671|144539458|OTHER|||||||0.2091|||||||Mixed Models Analysis|The model evaluates effects from SNP, diet and SNP x diet interaction. Due to crossover design, period and sequence effects were adjusted in the model||SNP effect on Choline IER in Males||||0.2091
72504447|NCT03726671|144539458|OTHER|||||||0.8141|||||||Mixed Models Analysis|The model evaluates effects from SNP, diet and SNP x diet interaction. Due to crossover design, period and sequence effects were adjusted in the model||SNP effect on Phosphatidylcholine IER in Pre-Menopausal Females||||0.8141
72616342|NCT03277274|144763350|OTHER|TAK-954 (Total): An ANOVA were performed on log transformed AUCinf (Total TAK-954) to compare each hepatically impaired group with the normal hepatic function group.||||||0.029|||||||ANOVA|||||||0.029
72616343|NCT03277274|144763350|OTHER|TAK-954 (Free): An ANOVA were performed on log transformed AUCinf (Free TAK-954) to compare each hepatically impaired group with the normal hepatic function group.||||||0.201|||||||ANOVA|||||||0.201
72616344|NCT03277274|144763350|OTHER|TAK-954 (Free): An ANOVA were performed on log transformed AUCinf (Free TAK-954) to compare each hepatically impaired group with the normal hepatic function group.||||||0.023|||||||ANOVA|||||||0.023
72616345|NCT03921541|144763356|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||||||<0.0001
72616346|NCT03921541|144763357|SUPERIORITY|||||||0.5961|||||||Mixed Models Analysis|||||||0.5961
72616347|NCT03921541|144763358|SUPERIORITY|||||||0.1087|||||||Mixed Models Analysis|||||||0.1087
72616348|NCT03921541|144763359|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||||||<0.0001
72616349|NCT03921541|144763360|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||||||<0.0001
72616350|NCT03921541|144763361|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||||||<0.0001
72616351|NCT03921541|144763363|SUPERIORITY|||||||0.0003|||||||Mixed Models Analysis|||||||0.0003
72616352|NCT03921541|144763364|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||||||<0.0001
72616353|NCT03921541|144763365|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||||||<0.0001
72616354|NCT03921541|144763366|SUPERIORITY|||||||0.0208|||||||Mixed Models Analysis|||||||0.0208
72616355|NCT03921541|144763367|SUPERIORITY|||||||0.4434|||||||Mixed Models Analysis|||||||0.4434
72616356|NCT03921541|144763368|SUPERIORITY|||||||0.5301|||||||Mixed Models Analysis|||||||0.5301
72616357|NCT03921541|144763369|SUPERIORITY|||||||0.2515|||||||Mixed Models Analysis|||||||0.2515
72616358|NCT04633447|144763395|SUPERIORITY||Difference in Percentage|6.6|||=|0.638|TWO_SIDED|90.0|-14.7|27.9|||Cochran-Mantel-Haenszel|||||27.9|-14.7|=0.638
72616359|NCT01778985|144763416|SUPERIORITY_OR_OTHER|||||||0.21|||||||t-test, 2 sided|||||||0.21
72616360|NCT01778985|144763417|SUPERIORITY_OR_OTHER|||||||0.002|||||||t-test, 2 sided|||||||0.002
72616361|NCT01778985|144763418|SUPERIORITY_OR_OTHER|||||||0.22|||||||t-test, 2 sided|||||||0.22
72616362|NCT01778985|144763419|SUPERIORITY_OR_OTHER|||||||0.088|||||||t-test, 2 sided|t(18)=1.78, p=0.088||||||0.088
72616363|NCT01778985|144763420|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
72616364|NCT01778985|144763421|SUPERIORITY_OR_OTHER|||||||0.91||||||t(28)=0.11, p=0.91|t-test, 2 sided|||||||0.91
72616365|NCT01778985|144763422|SUPERIORITY_OR_OTHER|||||||0.1||||||t(18)=1.69, p=.10|t-test, 2 sided|||||||0.10
72616366|NCT01778985|144763423|SUPERIORITY_OR_OTHER|||||||0.02||||||t(10)=2.76, p=0.020|t-test, 2 sided|||||||0.020
72616367|NCT01778985|144763424|SUPERIORITY_OR_OTHER|||||||0.78||||||t(23)=0.28, p=0.78|t-test, 2 sided|||||||0.78
72616368|NCT01778985|144763425|SUPERIORITY_OR_OTHER|||||||0.51||||||t(28)=0.67, p=0.51|t-test, 2 sided|||||||0.51
72616369|NCT01778985|144763426|SUPERIORITY_OR_OTHER|||||||0.24||||||t(23)=1.23, p=0.24|t-test, 2 sided|||||||0.24
72616370|NCT01778985|144763427|SUPERIORITY_OR_OTHER|||||||0.53|||||||t-test, 2 sided|||||||0.53
72616371|NCT01778985|144763428|SUPERIORITY_OR_OTHER|||||||0.33|||||||t-test, 2 sided|||||||0.33
72616372|NCT01778985|144763429|SUPERIORITY_OR_OTHER|||||||0.05|||||||Wilcoxon (Mann-Whitney)|||||||0.05
72616373|NCT01778985|144763430|SUPERIORITY_OR_OTHER|||||||0.15|||||||t-test, 2 sided|||||||0.15
72616374|NCT01778985|144763431|SUPERIORITY_OR_OTHER|||||||0.82|||||||t-test, 2 sided|||||||0.82
72616375|NCT01778985|144763432|SUPERIORITY_OR_OTHER|||||||0.7|||||||t-test, 2 sided|||||||0.70
72616376|NCT01778985|144763433|SUPERIORITY_OR_OTHER|||||||0.25|||||||t-test, 2 sided|||||||0.25
72616377|NCT01778985|144763434|SUPERIORITY_OR_OTHER|||||||0.06|||||||t-test, 2 sided|||||||0.06
72616378|NCT01778985|144763435|SUPERIORITY_OR_OTHER|||||||1|||||||t-test, 2 sided|||||||1
72616379|NCT00835978|144763447|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.578||||0.0189|TWO_SIDED|95.0|1.017|2.448||A priori defined threshold for statistical significance was: alpha=0.10 (one-sided)|Cochran-Mantel-Haenszel|||ORR for the 2 treatment arms was compared with the Cochran-Mantel-Haenszel test stratified by ECOG performance status. The relative risk ratio estimator was used to contrast the treatment effects on the endpoint. Both a point estimate and a 2-sided 95% CI were calculated using a normal approximation.||2.448|1.017|0.0189
72616380|NCT00835978|144763448|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.849||||0.2444|TWO_SIDED|95.0|0.535|1.348|||Log Rank|||||1.348|0.535|0.2444
72616381|NCT00327171|144763517|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.123||||0.5043|TWO_SIDED|95.0|0.8|1.58|||Log Rank||Estimated using Cox proportional Hazard model using treatment as the factor|||1.58|0.80|0.5043
72616382|NCT00327171|144763520|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.093||||0.5592|TWO_SIDED|95.0|0.81|1.48|||Log Rank||Estimated using Cox proportional Hazard model using treatment as the factor (4mg/kg vs. 2mg/kg)|||1.48|0.81|0.5592
72616383|NCT00327171|144763521|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.124||||0.5457|TWO_SIDED|95.0|0.77|1.64|||Log Rank||Estimated using Cox proportional Hazard model using treatment as the factor (4 mg/kg vs. 2mg/kg)|||1.64|0.77|0.5457
72616384|NCT01363440|144763525|SUPERIORITY_OR_OTHER||Mean Difference (Net)|12.19|||<|0.0001|TWO_SIDED|97.5|9.35|15.04|||ANCOVA|||||15.04|9.35|<.0001
72616385|NCT01363440|144763525|SUPERIORITY_OR_OTHER||Mean Difference (Net)|10.45|||<|0.0001|TWO_SIDED|97.5|7.73|13.17|||ANCOVA|||||13.17|7.73|<.0001
72493493|NCT02469090|144516213|SUPERIORITY||Adjusted odds ratio|2.8||||0.0501|TWO_SIDED|95.0|1.0|7.84||The hierarchical testing stopped at this endpoint due to non-significant result. P-values for endpoints after this endpoint have not been presented and the confidence interval presented are unadjusted for multiplicity.|Adjusted odds ratio|||"This was analyzed using a generalized linear mixed model (with logit link function) for binomial data. The model included the observed outcomes as the response values, with treatment group, visit, and the interaction between treatment group and visit as fixed factors and the ON/OFF assessment at the last open-label titration visit at which the randomized dose was given as a covariate."||7.84|1.00|0.0501
72554984|NCT03086460|144641769|SUPERIORITY||Mean Difference (Final Values)|0.05||||0.082|TWO_SIDED|95.0|-0.006|0.107|||ANCOVA|||"Day 1~Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.107|-0.006|0.082
72554985|NCT03086460|144641769|SUPERIORITY||Mean Difference (Final Values)|0.097|||<|0.001|TWO_SIDED|95.0|0.043|0.152|||ANCOVA|||"Day 1~Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.152|0.043|<0.001
72554986|NCT03086460|144641769|SUPERIORITY||Mean Difference (Final Values)|0.02||||0.52|TWO_SIDED|95.0|-0.041|0.08|||ANCOVA|||"Day 1~Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment B (CHF 1531 pMDI 12 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.080|-0.041|0.520
72554987|NCT03086460|144641769|SUPERIORITY||Mean Difference (Final Values)|0.067||||0.022|TWO_SIDED|95.0|0.01|0.124|||ANCOVA|||"Day 1~Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment B (CHF 1531 pMDI 12 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.124|0.010|0.022
72554988|NCT03086460|144641769|SUPERIORITY||Mean Difference (Final Values)|0.047||||0.098|TWO_SIDED|95.0|-0.009|0.103|||ANCOVA|||"Day 1~Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment C (CHF 1531 pMDI 24 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.103|-0.009|0.098
72493494|NCT02469090|144516216|SUPERIORITY||LS mean difference|-1.1|||||TWO_SIDED|95.0|-3.159|0.959||||||||0.959|-3.159|
72493495|NCT02469090|144516217|SUPERIORITY||LS mean difference|47.6|||||TWO_SIDED|95.0|28.84|66.36||||||||66.36|28.84|
72493496|NCT02469090|144516218|SUPERIORITY||LS mean difference|1.979|||||TWO_SIDED|95.0|-2.162|6.12||||||||6.120|-2.162|
72493497|NCT02469090|144516219|SUPERIORITY||LS mean difference|-3.4|||||TWO_SIDED|95.0|-6.7|-0.2||||||||-0.2|-6.7|
72493498|NCT02469090|144516220|SUPERIORITY||Hazard ratio|3.4|||||TWO_SIDED|95.0|1.99|5.69||||||Median Time to effect for APL-130277 versus placebo patients||5.69|1.99|
72493499|NCT01202656|144516240|SUPERIORITY_OR_OTHER|||||||0.72|||||||Cochran-Mantel-Haenszel|||||||0.72
72493500|NCT00355394|144516243|SUPERIORITY_OR_OTHER|||||||0.03|||||||Fisher Exact|||||||0.03
72493501|NCT00355394|144516244|SUPERIORITY_OR_OTHER|||||||0.02|||||||Fisher Exact|||||||0.02
72493502|NCT00355394|144516245|SUPERIORITY_OR_OTHER|||||||0.46|||||||Fisher Exact|||||||0.46
72493503|NCT00355394|144516246|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.002
72493504|NCT00355394|144516247|SUPERIORITY_OR_OTHER|||||||0.01||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.01
72493505|NCT00355394|144516248|SUPERIORITY_OR_OTHER|||||||0.5||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.50
72493506|NCT00411554|144516256|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin (Sitagliptin minus Voglibose) = 0.2 percent|Least-squares Mean Difference|-0.39|||<|0.001||95.0|-0.51|-0.28||"This p-value corresponds to a test of superiority that was performed after success was achieved in the test of non-inferiority (reported under Estimation below), according to the pre-specified analysis plan"|ANCOVA|ANCOVA model with terms of treatment, prior antihyperglycemic medication status and baseline was used to compare two groups|ANCOVA model with terms of treatment, prior antihyperglycemic medication status and baseline was used to show non-inferiority and superiority to voglibose (closed procedure) and to estimate difference of two groups and its 95% confidence interval|||-0.28|-0.51|<0.001
72493507|NCT00411554|144516257|SUPERIORITY_OR_OTHER||Least-squares Mean Difference|-10.7|||<|0.001||95.0|-15.3|-6.2|||ANCOVA|ANCOVA model with terms of treatment, prior antihyperglycemic medication status and baseline was used to compare two groups|ANCOVA model with terms of treatment, prior antihyperglycemic medication status and baseline was used to show superiority to voglibose and to estimate difference of two groups and its 95% confidence interval|||-6.2|-15.3|<0.001
72493508|NCT00411554|144516258|SUPERIORITY_OR_OTHER||Least-squares Mean Difference|-18.8|||<|0.001||95.0|-26.7|-10.9|||ANCOVA|ANCOVA model with terms of treatment, prior antihyperglycemic medication status and baseline was used to compare two groups|ANCOVA model with terms of treatment, prior antihyperglycemic medication status and baseline was used to show superiority to voglibose and to estimate difference of two groups and its 95% confidence interval|||-10.9|-26.7|<0.001
72493509|NCT00699907|144516259|SUPERIORITY_OR_OTHER|||||||0.012|||||||Wilcoxon Rank Sum Test|||||||0.012
72616386|NCT01363440|144763526|SUPERIORITY_OR_OTHER||Mean Difference (Net)|45.9||||0.0001|TWO_SIDED|97.5|34.7|57.0|||Cochran-Mantel-Haenszel|||||57.0|34.7|.0001
72616387|NCT01363440|144763526|SUPERIORITY_OR_OTHER||Mean Difference (Net)|38.8||||0.0001|TWO_SIDED|97.5|27.2|50.3|||Cochran-Mantel-Haenszel|||||50.3|27.2|.0001
72493510|NCT00699907|144516259|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Wilcoxon Rank Sum Test|||||||>0.05
72493511|NCT00699907|144516260|SUPERIORITY_OR_OTHER|||||||0.01|||||||Wilcoxon Rank Sum Test|||||||0.010
72493512|NCT00699907|144516260|SUPERIORITY_OR_OTHER|||||||0.005|||||||Wilcoxon Rank Sum Test|||||||0.005
72493513|NCT00699907|144516261|SUPERIORITY_OR_OTHER|||||||0.0006|||||||Wilcoxon Rank Sum Test|||||||0.0006
72493514|NCT00699907|144516261|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Wilcoxon Rank Sum Test|||||||>0.05
72493515|NCT00699907|144516262|SUPERIORITY_OR_OTHER|||||||0.009|||||||Wilcoxon Rank Sum Test|||||||0.009
72493516|NCT00699907|144516262|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Wilcoxon Rank Sum Test|||||||>0.05
72493517|NCT00699907|144516263|SUPERIORITY_OR_OTHER|||||||0.037|||||||Wilcoxon Rank Sum Test|||||||0.037
72493518|NCT00699907|144516263|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Wilcoxon Rank Sum Test|||||||>0.05
72493519|NCT00699907|144516264|SUPERIORITY_OR_OTHER|||||||0.01|||||||Wilcoxon Rank Sum Test|||||||0.010
72616388|NCT01363440|144763527|SUPERIORITY_OR_OTHER||Mean Difference (Net)|34.2|||<|0.0001|TWO_SIDED|97.5|24.1|44.4|||Cochran-Mantel-Haenszel|||||44.4|24.1|<0.0001
72554989|NCT03086460|144641769|SUPERIORITY||Mean Difference (Final Values)|0.153|||<|0.001|TWO_SIDED|95.0|0.095|0.21|||ANCOVA|||"Day 14~Comparison groups were:~Treatment A (CHF 1531 pMDI 6 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.210|0.095|<0.001
72554990|NCT03086460|144641769|SUPERIORITY||Mean Difference (Final Values)|0.19|||<|0.001|TWO_SIDED|95.0|0.131|0.249|||ANCOVA|||"Day 14~Comparison groups were:~Treatment B (CHF 1531 pMDI 12 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.249|0.131|<0.001
72554991|NCT03086460|144641769|SUPERIORITY||Mean Difference (Final Values)|0.17|||<|0.001|TWO_SIDED|95.0|0.113|0.228|||ANCOVA|||"Day 14~Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.228|0.113|<0.001
72554992|NCT03086460|144641769|SUPERIORITY||Mean Difference (Final Values)|0.217|||<|0.001|TWO_SIDED|95.0|0.162|0.272|||ANCOVA|||"Day 14~Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.272|0.162|<0.001
72554993|NCT03086460|144641769|SUPERIORITY||Mean Difference (Final Values)|0.198|||<|0.001|TWO_SIDED|95.0|0.144|0.252|||ANCOVA|||"Day 14~Comparison groups were:~Treatment F ( Perforomist® IS 40 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.252|0.144|<0.001
72554994|NCT03086460|144641769|SUPERIORITY||Mean Difference (Final Values)|0.037||||0.203|TWO_SIDED|95.0|-0.02|0.095|||ANCOVA|||"Day 14~Comparison groups were:~Treatment B (CHF 1531 pMDI 12 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.095|-0.020|0.203
72554995|NCT03086460|144641769|SUPERIORITY||Mean Difference (Final Values)|0.017||||0.542|TWO_SIDED|95.0|-0.039|0.074|||ANCOVA|||"Day 14~Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.074|-0.039|0.542
72554996|NCT03086460|144641769|SUPERIORITY||Mean Difference (Final Values)|0.064||||0.021|TWO_SIDED|95.0|0.01|0.119|||ANCOVA|||"Day 14~Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.119|0.010|0.021
72554997|NCT03086460|144641769|SUPERIORITY||Mean Difference (Final Values)|-0.02||||0.51|TWO_SIDED|95.0|-0.08|0.04|||ANCOVA|||"Day 14~Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment B (CHF 1531 pMDI 12 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.040|-0.080|0.510
72616389|NCT01363440|144763527|SUPERIORITY_OR_OTHER||Mean Difference (Net)|23.3|||<|0.0001|TWO_SIDED|97.5|13.5|33.1|||Cochran-Mantel-Haenszel|||||33.1|13.5|<.0001
72554998|NCT03086460|144641769|SUPERIORITY||Mean Difference (Final Values)|0.027||||0.352|TWO_SIDED|95.0|-0.03|0.084|||ANCOVA|||"Day 14~Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment B (CHF 1531 pMDI 12 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.084|-0.030|0.352
72554999|NCT03086460|144641769|SUPERIORITY||Mean Difference (Final Values)|0.047||||0.098|TWO_SIDED|95.0|-0.009|0.103|||ANCOVA|||"Day 14~Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment C (CHF 1531 pMDI 24 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.103|-0.009|0.098
72555000|NCT03086460|144641770|SUPERIORITY||Mean Difference (Final Values)|0.181|||<|0.001|TWO_SIDED|95.0|0.122|0.241|||ANCOVA|||"Day 1~Comparison groups were:~Treatment A (CHF 1531 pMDI 6 μg TDD) versus Treatment E (Placebo).~This secondary efficacy variable was analyzed using the ANCOVA model that was also used for the primary efficacy analysis, without adjusting for multiplicity."||0.241|0.122|<0.001
72555001|NCT03086460|144641770|SUPERIORITY||Mean Difference (Final Values)|0.192|||<|0.001|TWO_SIDED|95.0|0.133|0.251|||ANCOVA|||"Day 1~Comparison groups were:~Treatment B (CHF 1531 pMDI 12 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.251|0.133|<0.001
72555002|NCT03086460|144641770|SUPERIORITY||Mean Difference (Final Values)|0.215|||<|0.001|TWO_SIDED|95.0|0.156|0.275|||ANCOVA|||"Day 1~Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.275|0.156|<0.001
72555003|NCT03086460|144641770|SUPERIORITY||Mean Difference (Final Values)|0.252|||<|0.001|TWO_SIDED|95.0|0.195|0.309|||ANCOVA|||"Day 1~Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.309|0.195|<0.001
72555004|NCT03086460|144641770|SUPERIORITY||Mean Difference (Final Values)|0.238|||<|0.001|TWO_SIDED|95.0|0.182|0.295|||ANCOVA|||"Day 1~Comparison groups were:~Treatment F ( Perforomist® IS 40 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.295|0.182|<0.001
72555005|NCT03086460|144641770|SUPERIORITY||Mean Difference (Final Values)|0.011||||0.723|TWO_SIDED|95.0|-0.049|0.071|||ANCOVA|||"Day 1~Comparison groups were:~Treatment B (CHF 1531 pMDI 12 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.071|-0.049|0.723
72555006|NCT03086460|144641770|SUPERIORITY||Mean Difference (Final Values)|0.034||||0.257|TWO_SIDED|95.0|-0.025|0.093|||ANCOVA|||"Day 1~Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.093|-0.025|0.257
72616390|NCT01363440|144763528|SUPERIORITY_OR_OTHER||Mean Difference (Net)|19.7|||<|0.0001|TWO_SIDED|97.5|9.0|30.4|||Cochran-Mantel-Haenszel|||||30.4|9.0|<.0001
72616391|NCT01363440|144763528|SUPERIORITY_OR_OTHER||Mean Difference (Net)|14.9||||0.0017|TWO_SIDED|97.5|4.4|25.4|||Cochran-Mantel-Haenszel|||||25.4|4.4|0.0017
72616392|NCT01363440|144763529|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-110.8|||<|0.0001|TWO_SIDED|97.5|-141.3|-80.22|||ANCOVA|||||-80.22|-141.3|<.0001
72616393|NCT01363440|144763529|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-113.5|||<|0.0001|TWO_SIDED|97.5|-144.2|-82.75|||ANCOVA|||||-82.75|-144.2|<.0001
72616394|NCT01363440|144763530|SUPERIORITY_OR_OTHER||Mean Difference (Net)|5.19||||0.0168||97.5|0.33|10.04|||ANCOVA|||||10.04|0.33|0.0168
72616395|NCT01363440|144763530|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.36||||0.0323|TWO_SIDED|97.5|-0.21|8.93|||ANCOVA|||||8.93|-0.21|0.0323
72616396|NCT01363440|144763531|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.86||||0.1702|TWO_SIDED|97.5|-1.82|7.54|||ANCOVA|||||7.54|-1.82|0.1702
72616397|NCT01363440|144763531|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.65||||0.4067|TWO_SIDED|97.5|-2.83|6.13|||ANCOVA|||||6.13|-2.83|0.4067
72616398|NCT00758043|144763585|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Estimated by evaluating the treatment differences in the SVR24planned rates (T12PR24/eRVR+ minus T12PR48/eRVR+) and the 95% CI for these groups (the entire 2 sided CI is to the right of the predefined non-inferiority margin of -10.5%).|Difference in proportions|4.5|||||TWO_SIDED|95.0|-2.1|11.1||||||Primary efficacy analysis was based on CI estimates (using the normal approximation, confidence limits were constructed for the difference in proportions) to rule out the inferiority of the T12/PR24/eRVR+ treatment regimen relative to the T12/PR48/eRVR+ treatment regimen. SVR24 was defined as undetectable HCV RNA at end of treatment through 24 weeks after the last planned dose.||11.1|-2.1|
72616399|NCT00758043|144763585|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Estimated by evaluating the treatment differences in the SVR24planned rates (T12PR24/eRVR+ minus T12PR48/eRVR+) and the 95% CI for these groups (the entire 2 sided CI is to the right of the predefined non-inferiority margin of -10.5%).|Difference in proportions|2.0|||||TWO_SIDED|95.0|-4.3|8.2||||||SVR24 was defined as below the limit of quantitation at 24 weeks after the planned end of treatment. For subjects who had missing data at week 24 after the planned end of treatment, the week 12 data or the last follow-up time point after week 12 was carried forward for determining SVR24.||8.2|-4.3|
72616400|NCT00758043|144763586|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Estimated by evaluating the treatment differences in the SVR at Week 72 planned rates (T12PR24/eRVR+ minus T12PR48/eRVR+) and the 95% CI for these groups (the entire 2 sided CI is to the right of the predefined non-inferiority margin of 10.5%).|Difference in Proportion|-0.5|||||TWO_SIDED|95.0|-7.7|6.8||||||||6.8|-7.7|
72616401|NCT00758043|144763586|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Estimated by evaluating the treatment differences in the SVR at Week 72 planned rates (T12PR24/eRVR+ minus T12PR48/eRVR+) and the 95% CI for these groups (the entire 2 sided CI is to the right of the predefined non-inferiority margin of 10.5%).|Odds Ratio, log|0.94|||||TWO_SIDED|95.0|0.49|1.82||||||||1.82|0.49|
72616402|NCT02400580|144763605|OTHER|||||||0.517|||||||Fisher Exact|||||||0.517
72616403|NCT02400580|144763607|OTHER|||||||0.508|||||||Fisher Exact|||||||0.508
72616404|NCT01336972|144763615|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|||||Test to compare Final Treatment versus Baseline|paired t-test|||A change of 10% was chosen as representing a clinically significant change in mGFR or ERPF. For this purpose, the alpha level was set at 0.05 and the beta level (power) at 95% instead of 80%, to decrease the chance of a false-negative finding.||||<0.05
72616405|NCT01336972|144763615|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|||||Test to compare Final Treatment versus Baseline|paited t-test|||A change of 10% was chosen as representing a clinically significant change in mGFR or ERPF. For this purpose, the alpha level was set at 0.05 and the beta level (power) at 95% instead of 80%, to decrease the chance of a false-negative finding.||||<0.05
72616406|NCT01336972|144763615|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||Test to compare Final Treatment versus Baseline|paired t-test|||A change of 10% was chosen as representing a clinically significant change in mGFR or ERPF. For this purpose, the alpha level was set at 0.05 and the beta level (power) at 95% instead of 80%, to decrease the chance of a false-negative finding.||||>0.05
72371576|NCT00669409|144253441|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-12.7|STANDARD_ERROR_OF_MEAN|7.88|||TWO_SIDED|95.0|-28.3|2.9||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||2.9|-28.3|
72616407|NCT01336972|144763615|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||Test to compare Post Treatment versus Baseline|paired t-test|||A change of 10% was chosen as representing a clinically significant change in mGFR or ERPF. For this purpose, the alpha level was set at 0.05 and the beta level (power) at 95% instead of 80%, to decrease the chance of a false-negative finding.||||>0.05
72616408|NCT01336972|144763615|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||Test to compare Post Treatment versus Baseline|paired t-test|||A change of 10% was chosen as representing a clinically significant change in mGFR or ERPF. For this purpose, the alpha level was set at 0.05 and the beta level (power) at 95% instead of 80%, to decrease the chance of a false-negative finding.||||>0.05
72616409|NCT01336972|144763615|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||Test to compare Post Treatment versus Baseline|paired t-test|||A change of 10% was chosen as representing a clinically significant change in mGFR or ERPF. For this purpose, the alpha level was set at 0.05 and the beta level (power) at 95% instead of 80%, to decrease the chance of a false-negative finding.||||>0.05
72616410|NCT01336972|144763615|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||Test to compare treatment groups at Final Treatment|Wilcoxon (Mann-Whitney)|||A change of 10% was chosen as representing a clinically significant change in mGFR or ERPF. For this purpose, the alpha level was set at 0.05 and the beta level (power) at 95% instead of 80%, to decrease the chance of a false-negative finding.||||>0.05
72432375|NCT02696785|144377173|SUPERIORITY||LSMean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.48||0.317|TWO_SIDED|95.0|-1.4|0.5|||Mixed Models Analysis|||||0.5|-1.4|0.317
72616411|NCT01336972|144763615|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||Test to compare treatment groups at Final Treatment|Wilcoxon (Mann-Whitney)|||A change of 10% was chosen as representing a clinically significant change in mGFR or ERPF. For this purpose, the alpha level was set at 0.05 and the beta level (power) at 95% instead of 80%, to decrease the chance of a false-negative finding.||||>0.05
72616412|NCT01336972|144763615|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|||||Test to compare treatment groups at Final Treatment|Wilcoxon (Mann-Whitney)|||A change of 10% was chosen as representing a clinically significant change in mGFR or ERPF. For this purpose, the alpha level was set at 0.05 and the beta level (power) at 95% instead of 80%, to decrease the chance of a false-negative finding.||||<0.05
72616413|NCT01336972|144763615|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||Test to compare treatment groups at Post Treatment|Wilcoxon (Mann-Whitney)|||A change of 10% was chosen as representing a clinically significant change in mGFR or ERPF. For this purpose, the alpha level was set at 0.05 and the beta level (power) at 95% instead of 80%, to decrease the chance of a false-negative finding.||||>0.05
72371577|NCT00669409|144253441|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-28.9|STANDARD_ERROR_OF_MEAN|10.48|||TWO_SIDED|95.0|-49.6|-8.2||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-8.2|-49.6|
72616414|NCT01336972|144763615|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||A change of 10% was chosen as representing a clinically significant change in mGFR or ERPF. For this purpose, the alpha level was set at 0.05 and the beta level (power) at 95% instead of 80%, to decrease the chance of a false-negative finding.||||>0.05
72616415|NCT01336972|144763615|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||A change of 10% was chosen as representing a clinically significant change in mGFR or ERPF. For this purpose, the alpha level was set at 0.05 and the beta level (power) at 95% instead of 80%, to decrease the chance of a false-negative finding.||||>0.05
72371578|NCT00669409|144253442|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|7.98|||TWO_SIDED|95.0|-16.8|14.8||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||14.8|-16.8|
72371579|NCT00669409|144253442|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-19.3|STANDARD_ERROR_OF_MEAN|7.98|||TWO_SIDED|95.0|-35.0|-3.5||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-3.5|-35.0|
72371580|NCT00669409|144253442|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-6.0|STANDARD_ERROR_OF_MEAN|7.99|||TWO_SIDED|95.0|-21.8|9.8||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||9.8|-21.8|
72371581|NCT00669409|144253442|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-12.4|STANDARD_ERROR_OF_MEAN|7.88|||TWO_SIDED|95.0|-28.0|3.2||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||3.2|-28.0|
72371582|NCT00669409|144253442|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-29.9|STANDARD_ERROR_OF_MEAN|10.48|||TWO_SIDED|95.0|-50.6|-9.1||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-9.1|-50.6|
72371583|NCT00669409|144253443|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|3.9|STANDARD_ERROR_OF_MEAN|7.98|||TWO_SIDED|95.0|-11.9|19.7||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||19.7|-11.9|
72371584|NCT00669409|144253443|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-19.3|STANDARD_ERROR_OF_MEAN|7.98|||TWO_SIDED|95.0|-35.1|-3.6||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-3.6|-35.1|
72432376|NCT02696785|144377173|SUPERIORITY||LSMean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.48||0.683|TWO_SIDED|95.0|-1.1|0.8|||Mixed Models Analysis|||||0.8|-1.1|0.683
72616416|NCT01336972|144763616|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||Test to compare Final Treatment versus Baseline for all treatment groups|paired t-test|||A change of 10% was chosen as representing a clinically significant change in mGFR or ERPF. For this purpose, the alpha level was set at 0.05 and the beta level (power) at 95% instead of 80%, to decrease the chance of a false-negative finding.||||>0.05
72616417|NCT01336972|144763616|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||Test to compare Post Treatment versus Baseline for all treatment groups|paired t-test|||A change of 10% was chosen as representing a clinically significant change in mGFR or ERPF. For this purpose, the alpha level was set at 0.05 and the beta level (power) at 95% instead of 80%, to decrease the chance of a false-negative finding.||||>0.05
72616418|NCT01336972|144763616|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||Test to compare treatment groups at Final Treatment|Wilcoxon (Mann-Whitney)|||A change of 10% was chosen as representing a clinically significant change in mGFR or ERPF. For this purpose, the alpha level was set at 0.05 and the beta level (power) at 95% instead of 80%, to decrease the chance of a false-negative finding.||||>0.05
72616419|NCT01336972|144763616|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||Test to compare treatment groups at Final Treatment|Wilcoxon (Mann-Whitney)|||A change of 10% was chosen as representing a clinically significant change in mGFR or ERPF. For this purpose, the alpha level was set at 0.05 and the beta level (power) at 95% instead of 80%, to decrease the chance of a false-negative finding.||||>0.05
72616420|NCT01336972|144763616|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||Test to compare treatment groups at Post Treatment|Wilcoxon (Mann-Whitney)|||A change of 10% was chosen as representing a clinically significant change in mGFR or ERPF. For this purpose, the alpha level was set at 0.05 and the beta level (power) at 95% instead of 80%, to decrease the chance of a false-negative finding.||||>0.05
72616421|NCT01336972|144763616|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||Test to compare treatment groups at Post Treatment|Wilcoxon (Mann-Whitney)|||A change of 10% was chosen as representing a clinically significant change in mGFR or ERPF. For this purpose, the alpha level was set at 0.05 and the beta level (power) at 95% instead of 80%, to decrease the chance of a false-negative finding.||||>0.05
72616422|NCT01336972|144763616|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||Test to compare treatment groups at Post Treatment|Wilcoxon (Mann-Whitney)|||A change of 10% was chosen as representing a clinically significant change in mGFR or ERPF. For this purpose, the alpha level was set at 0.05 and the beta level (power) at 95% instead of 80%, to decrease the chance of a false-negative finding.||||>0.05
72616423|NCT01336972|144763617|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||Test to compare Final Treatment versus Baseline|paired t-test|||A change of 10% was chosen as representing a clinically significant change in mGFR or ERPF. For this purpose, the alpha level was set at 0.05 and the beta level (power) at 95% instead of 80%, to decrease the chance of a false-negative finding.||||>0.05
72616424|NCT01336972|144763617|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||Test to compare Post Treatment versus Baseline for all treatment groups|paired t-test|||A change of 10% was chosen as representing a clinically significant change in mGFR or ERPF. For this purpose, the alpha level was set at 0.05 and the beta level (power) at 95% instead of 80%, to decrease the chance of a false-negative finding.||||>0.05
72616425|NCT01336972|144763617|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||Test to compare treatment groups at Final Treatment|Wilcoxon (Mann-Whitney)|||A change of 10% was chosen as representing a clinically significant change in mGFR or ERPF. For this purpose, the alpha level was set at 0.05 and the beta level (power) at 95% instead of 80%, to decrease the chance of a false-negative finding.||||>0.05
72371585|NCT00669409|144253443|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-5.5|STANDARD_ERROR_OF_MEAN|7.99|||TWO_SIDED|95.0|-21.3|10.3||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||10.3|-21.3|
72616426|NCT01336972|144763617|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||Test to compare treatment groups at Final Treatment|Wilcoxon (Mann-Whitney)|||A change of 10% was chosen as representing a clinically significant change in mGFR or ERPF. For this purpose, the alpha level was set at 0.05 and the beta level (power) at 95% instead of 80%, to decrease the chance of a false-negative finding||||>0.05
72616427|NCT01336972|144763617|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||Test to compare treatment groups at Final Treatment|Wilcoxon (Mann-Whitney)|||A change of 10% was chosen as representing a clinically significant change in mGFR or ERPF. For this purpose, the alpha level was set at 0.05 and the beta level (power) at 95% instead of 80%, to decrease the chance of a false-negative finding.||||>0.05
72616428|NCT01336972|144763617|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||Test to compare treatment groups at Post Treatment|Wilcoxon (Mann-Whitney)|||A change of 10% was chosen as representing a clinically significant change in mGFR or ERPF. For this purpose, the alpha level was set at 0.05 and the beta level (power) at 95% instead of 80%, to decrease the chance of a false-negative finding.||||>0.05
72616429|NCT01336972|144763617|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|||||Test to compare treatment groups at Post Treatment|Wilcoxon (Mann-Whitney)|||A change of 10% was chosen as representing a clinically significant change in mGFR or ERPF. For this purpose, the alpha level was set at 0.05 and the beta level (power) at 95% instead of 80%, to decrease the chance of a false-negative finding.||||<0.05
72616430|NCT01336972|144763617|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||Test to compare treatment groups at Post Treatment|Wilcoxon (Mann-Whitney)|||A change of 10% was chosen as representing a clinically significant change in mGFR or ERPF. For this purpose, the alpha level was set at 0.05 and the beta level (power) at 95% instead of 80%, to decrease the chance of a false-negative finding.||||>0.05
72616431|NCT01336972|144763618|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||paired t-test|||Test to compare Final Treatment versus Baseline for all treatment groups||||<0.05
72616432|NCT01336972|144763618|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||paired t-test|||Test to compare Post Treatment versus Baseline||||>0.05
72616433|NCT01336972|144763618|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||paired t-test|||Test to compare Post Treatment versus Baseline||||>0.05
72371586|NCT00669409|144253443|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-12.2|STANDARD_ERROR_OF_MEAN|7.88|||TWO_SIDED|95.0|-27.8|3.4||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||3.4|-27.8|
72493520|NCT00699907|144516264|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Wilcoxon Rank Sum Test|||||||>0.05
72616434|NCT01336972|144763618|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||paired t-test|||Test to compare Post Treatment versus Baseline||||<0.05
72616435|NCT01336972|144763618|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|Test to compare treatment groups at Final Treatment||||||>0.05
72616436|NCT01336972|144763618|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||Test to compare treatment groups at Final Treatment|paired t-test|||||||>0.05
72616437|NCT01336972|144763618|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||Test to compare treatment groups at Final Treatment|Wilcoxon (Mann-Whitney)|||||||>0.05
72616438|NCT01336972|144763618|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||Test to compare treatment groups at Post Treatment|Wilcoxon (Mann-Whitney)|||||||>0.05
72616439|NCT01336972|144763618|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||Test to compare treatment groups at Post Treatment|Wilcoxon (Mann-Whitney)|||||||>0.05
72616440|NCT01336972|144763618|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|||||Test to compare treatment groups at Post Treatment|Wilcoxon (Mann-Whitney)|||||||<0.05
72616441|NCT01336972|144763622|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||paired t-test|||Comparison of all treatment groups versus Baseline at Final Treatment||||<0.05
72616442|NCT01336972|144763622|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||paired t-test|||Comparison of all treatment groups versus Baseline at Post Treatment||||<0.05
72616443|NCT01336972|144763622|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Test to compare treatment groups at Final Treatment||||>0.05
72616444|NCT01336972|144763622|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Test to compare treatment groups at Final Treatment||||<0.05
72616445|NCT01336972|144763622|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Test to compare treatment groups at Final Treatment||||>0.05
72616446|NCT01336972|144763622|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Test to compare treatment groups at Post Treatment||||>0.05
72616447|NCT01336972|144763622|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Test to compare treatment groups at Post Treatment||||>0.05
72616448|NCT01336972|144763622|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Test to compare treatment groups at Post Treatment||||>0.05
72616449|NCT01336972|144763623|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Paired t-test|||Test to compare Final Treatment versus Baseline for all treatment groups||||<0.05
72616450|NCT01336972|144763623|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Test to compare treatment groups at Final Treatment||||<0.05
72616451|NCT01336972|144763623|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Test to compare treatment groups at Final Treatment||||>0.05
72616452|NCT01336972|144763623|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Test to compare treatment groups at Final Treatment||||<0.05
72616453|NCT01336972|144763623|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Paired t-test|||Test to compare PostTreatment versus Baseline for all treatment groups||||>0.05
72616454|NCT01336972|144763623|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Test to compare treatment groups at Post Treatment||||>0.05
72616455|NCT01336972|144763623|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Test to compare treatment groups at Post Treatment||||>0.05
72493521|NCT00699907|144516265|SUPERIORITY_OR_OTHER|||||||0.005|||||||Wilcoxon Rank Sum Test|||||||0.005
72616456|NCT01336972|144763623|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Test to compare treatment groups at Post Treatment||||<0.05
72616457|NCT01336972|144763624|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||paired te-test|||Test to compare Final Treatment versus Baseline for all treatment groups||||<0.05
72616458|NCT01336972|144763624|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Test to compare treatment groups at Final Treatment||||>0.05
72616459|NCT01336972|144763624|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Test to compare treatment groups at Final Treatment||||>0.05
72616460|NCT01336972|144763624|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Test to compare treatment groups at Final Treatment||||>0.05
72616461|NCT01336972|144763624|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||paired t-test|||Test to compare Post Treatment versus Baseline||||<0.05
72616462|NCT01336972|144763624|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||paired t-test|||Test to compare Post Treatment versus Baseline||||>0.05
72616463|NCT01336972|144763624|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Paired t-test|||Test to compare Post Treatment versus Baseline||||>0.05
72616464|NCT01336972|144763624|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Test to compare treatment groups at Post Treatment||||>0.05
72616465|NCT01336972|144763624|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Test to compare treatment groups at Post Treatment||||>0.05
72616466|NCT01336972|144763624|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Test to compare treatment groups at Post Treatment||||>0.05
72616467|NCT02030418|144763649|SUPERIORITY|"The primary safety hypothesis is:~H0: CFR ≤ 86% vs. H1: CFR \> 86% Where CFR is the Complication Free Rate. The CFR is estimated as a binomial proportion and the 95% confidence interval (CI) of CFR is calculated using the Clopper-Pearson exact method. The null hypothesis is rejected at the 2.5% significance level if the lower bound of this CI exceeds the Performance Goal (PG) of 86%."|binomial proportion|93.3|||<|0.001|TWO_SIDED|95.0|89.9|95.9|||1-sided exact test for binomial proporti|||||95.9|89.9|<0.001
72616468|NCT02030418|144763650|SUPERIORITY|"The primary effectiveness hypothesis is:~H0: Rate ≤ 85.0% vs. H1: Rate \> 85.0%~where Rate is the proportion of subjects experiencing success, and success is defined as: pacing threshold voltage ≤ 2.0 V at 0.4 ms at 6-month visit and sensed R-wave amplitude either ≥ 5.0 mV at the 6-month visit or ≥ value at implant."|binomial proportion|93.4|||<|0.001|TWO_SIDED|95.0|89.9|96.0||The null hypothesis is rejected at the 2.5% significance level if the lower bound of the CI exceeds the Performance Goal (PG) of 85%.|1-sided exact test for binomial proporti|||||96.0|89.9|<0.001
72622266|NCT04250207|144774534|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.||||||0.4642|||||||Chi-square or Fisher exact|||Week 16||||0.4642
72555007|NCT03086460|144641770|SUPERIORITY||Mean Difference (Final Values)|0.071||||0.016|TWO_SIDED|95.0|0.014|0.128|||ANCOVA|||"Day 1~Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.128|0.014|0.016
72555008|NCT03086460|144641770|SUPERIORITY||Mean Difference (Final Values)|0.023||||0.464|TWO_SIDED|95.0|-0.039|0.086|||ANCOVA|||"Day 1~Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment B (CHF 1531 pMDI 12 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.086|-0.039|0.464
72555009|NCT03086460|144641770|SUPERIORITY||Mean Difference (Final Values)|0.06||||0.048|TWO_SIDED|95.0|0.0|0.12|||ANCOVA|||"Day 1~Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment B (CHF 1531 pMDI 12 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.120|0.000|0.048
72555010|NCT03086460|144641770|SUPERIORITY||Mean Difference (Final Values)|0.037||||0.219|TWO_SIDED|95.0|-0.022|0.095|||ANCOVA|||"Day 1~Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment C (CHF 1531 pMDI 24 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.095|-0.022|0.219
72555011|NCT03086460|144641770|SUPERIORITY||Mean Difference (Final Values)|0.163|||<|0.001|TWO_SIDED|95.0|0.1|0.226|||ANCOVA|||"Day 14~Comparison groups were:~Treatment A (CHF 1531 pMDI 6 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.226|0.100|<0.001
72555012|NCT03086460|144641770|SUPERIORITY||Mean Difference (Final Values)|0.19|||<|0.001|TWO_SIDED|95.0|0.126|0.254|||ANCOVA|||"Day 14~Comparison groups were:~Treatment B (CHF 1531 pMDI 12 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.254|0.126|<0.001
72555013|NCT03086460|144641770|SUPERIORITY||Mean Difference (Final Values)|0.166|||<|0.001|TWO_SIDED|95.0|0.103|0.229|||ANCOVA|||"Day 14~Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.229|0.103|<0.001
72555014|NCT03086460|144641770|SUPERIORITY||Mean Difference (Final Values)|0.206|||<|0.001|TWO_SIDED|95.0|0.146|0.266|||ANCOVA|||"Day 14~Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.266|0.146|<0.001
72616469|NCT02030418|144763651|OTHER|"The hypothesis is intended to test whether the mean slope is within 35% of 1. The hypothesis is stated as follows:~H0: absolute value (Mean Slope - 100%) ≥ equivalence margin, equal to 35%~H1: absolute value (Mean Slope - 100%) \< equivalence margin, equal to 35%~The calculation of slope for individual subjects in the CAEP exercise protocol is done by setting the y-intercept to zero."|Slope|0.83|STANDARD_DEVIATION|0.27||0.001|TWO_SIDED|95.0|0.73|0.93|||two 1-sided test (TOST)|||||0.93|0.73|0.001
72616470|NCT02122952|144763663|SUPERIORITY||||||<|0.001|||||||One-sided Exact Binomial Test|||Data for the current study were compared to historical control data (Pediatric Neuromuscular Clinical Research \[PNCR\], Finkel et al 2014 - PubMed 25080519) where 0 participants were able to sit independently.||||<0.001
72616471|NCT02508207|144763664|OTHER|||||||0.7151||||||p-value for within TEZ/IVA group was analyzed using a 2-sided, paired, t-test at a 5% level of significance.|t-test, 2 sided|||||||0.7151
72616472|NCT02508207|144763665|OTHER|||||||0.0004||||||p-value for within TEZ/IVA group was analyzed using a 2-sided, paired, t-test at a 5% level of significance.|t-test, 2 sided|||||||0.0004
72616473|NCT02508207|144763666|OTHER|||||||0.3345|||||||t-test, 2 sided|p-value for within TEZ/IVA group was analyzed using a 2-sided, paired, t-test at a 5% level of significance.||||||0.3345
72616474|NCT02508207|144763667|OTHER|||||||0.0002||||||p-value for within TEZ/IVA group was analyzed using a 2-sided, paired, t-test at a 5% level of significance.|t-test, 2 sided|||||||0.0002
72616475|NCT00896233|144763669|SUPERIORITY_OR_OTHER||ICC|0.9|||||TWO_SIDED|90.0|0.81|0.99||||||ICC for measures of liver stiffness obtained by MRE (i.e., average over all 4 slices of the maximum stiffness for each slice) with respect to repeatability (precision) of multiple MRE assessments. This pertains to the Common ROI.||0.99|0.81|
72616476|NCT00896233|144763669|SUPERIORITY_OR_OTHER||ICC|0.85|||||TWO_SIDED|90.0|0.71|0.98||||||ICC for measures of liver stiffness obtained by MRE (i.e., average over all 4 slices of the maximum stiffness for each slice) with respect to repeatability (precision) of multiple MRE assessments. This pertains to the Common ROI.||0.98|0.71|
72616477|NCT00896233|144763669|SUPERIORITY_OR_OTHER||ICC|0.88|||||TWO_SIDED|90.0|0.78|0.98||||||ICC for measures of liver stiffness obtained by MRE (i.e., average over all 4 slices of the maximum stiffness for each slice) with respect to repeatability (precision) of multiple MRE assessments. This pertains to the Individual ROI.||0.98|0.78|
72616478|NCT00896233|144763669|SUPERIORITY_OR_OTHER||ICC|0.86|||||TWO_SIDED|90.0|0.75|0.98||||||ICC for measures of liver stiffness obtained by MRE (i.e., average over all 4 slices of the maximum stiffness for each slice) with respect to repeatability (precision) of multiple MRE assessments. This pertains to the Individual ROI.||0.98|0.75|
72616479|NCT00896233|144763670|SUPERIORITY_OR_OTHER||ICC|0.9|||||TWO_SIDED|90.0|0.8|0.99||||||ICC for measures of liver stiffness obtained by MRE (i.e., average over all 4 slices of the maximum stiffness for each slice) with respect to repeatability (precision) of multiple MRE assessments. This pertains to the Common ROI.||0.99|0.80|
72616480|NCT00896233|144763670|SUPERIORITY_OR_OTHER||ICC|0.88|||||TWO_SIDED|90.0|0.78|0.99||||||ICC for measures of liver stiffness obtained by MRE (i.e., average over all 4 slices of the maximum stiffness for each slice) with respect to repeatability (precision) of multiple MRE assessments. This pertains to the Common ROI.||0.99|0.78|
72616481|NCT00896233|144763670|SUPERIORITY_OR_OTHER||ICC|0.93|||||TWO_SIDED|90.0|0.87|1.0||||||ICC for measures of liver stiffness obtained by MRE (i.e., average over all 4 slices of the maximum stiffness for each slice) with respect to repeatability (precision) of multiple MRE assessments. This pertains to the Individual ROI.||1.00|0.87|
72432377|NCT02696785|144377173|SUPERIORITY||LSMean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.48||0.5|TWO_SIDED|95.0|-1.3|0.6|||Mixed Models Analysis|||||0.6|-1.3|0.500
72616482|NCT00896233|144763670|SUPERIORITY_OR_OTHER||ICC|0.94|||||TWO_SIDED|90.0|0.88|1.0||||||ICC for measures of liver stiffness obtained by MRE (i.e., average over all 4 slices of the maximum stiffness for each slice) with respect to repeatability (precision) of multiple MRE assessments. This pertains to the Individual ROI.||1.00|0.88|
72622267|NCT04250207|144774534|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.||||||0.4645|||||||Chi-square or Fisher exact|||Week 16||||0.4645
72622268|NCT04250207|144774534|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.||||||0.2744|||||||Chi-square or Fisher exact|||Week 20||||0.2744
72622269|NCT04250207|144774534|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.||||||0.7026|||||||Chi-square or Fisher exact|||Week 20||||0.7026
72622270|NCT04250207|144774534|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.||||||0.7817|||||||Chi-square or Fisher exact|||Week 24||||0.7817
72622271|NCT04250207|144774534|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.||||||0.9285|||||||Chi-square or Fisher exact|||Week 24||||0.9285
72622272|NCT04250207|144774534|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.||||||0.0135|||||||Chi-square or Fisher exact|||Week 38||||0.0135
72622273|NCT04250207|144774534|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.||||||0.6992|||||||Chi-square or Fisher exact|||Week 38||||0.6992
72616483|NCT00514917|144763692|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.29||||0.0501|TWO_SIDED|95.0|1.0|1.65||A priori threshold for statistical significance = 0.05|Log Rank|P-value was not adjusted for multiplicity of tests.|The hazard ratio Leuprolide+Bicalutamide vs. Docetaxel+Leuprolide+Bicalutamide was estimated using an un-stratified Cox proportional hazards model. A hazard ratio \>1 indicates a lower risk of Docetaxel+Leuprolide, compared to Leuprolide.|"Null hypothesis: No difference between new treatment combination (Docetaxel+Leuprolide+Bicalutamide) and conventional treatment (Leuprolide+Bicalutamide).~The study was sized to have 90% power to detect a difference between treatment arms at a 2-sided 0.05 significance level with 186 events and anticipating 10% non-evaluable participants."||1.65|1.00|0.0501
72616484|NCT00309244|144763711|NON_INFERIORITY_OR_EQUIVALENCE|Sample size was set to meet regulatory requirement of 250 subjects per arm with 52-week data, resulting in \> 90% power for a non-inferiority test of the difference in 12-month change of HbA1c scores between treatment groups with non-inferiority margin of 0.4%, standard deviation of 1.2 and 1-sided alpha of 0.025. Allowing for a 25% drop-out rate, 677 subjects were randomized.|Mean Difference (Final Values)|0.12|STANDARD_ERROR_OF_MEAN|0.085|||TWO_SIDED|95.0|-0.05|0.29|||ANCOVA|||||0.29|-0.05|
72616485|NCT00309244|144763712|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.6|STANDARD_ERROR_OF_MEAN|0.41||0.0002|TWO_SIDED|95.0|-2.4|-0.7|||ANCOVA|||ANCOVA model with terms of pooled site and treatment as fixed effects and baseline weight as covariate||-0.7|-2.4|0.0002
72616486|NCT00309244|144763713|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-17.7|STANDARD_ERROR_OF_MEAN|5.9||0.0029|TWO_SIDED|95.0|-29.3|-6.1|||ANCOVA|||ANCOVA model with terms of pooled site and treatment as fixed effects and baseline fasting plasma glucose as covariate||-6.1|-29.3|0.0029
72616487|NCT00309244|144763714|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.774||||0.2793|TWO_SIDED|95.0|0.486|1.231|||Regression, Logistic|||logistic regression analysis with the terms of treatment and baseline HbA1c in the model||1.231|0.486|0.2793
72616488|NCT00309244|144763715|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.423|||<|0.001|TWO_SIDED|95.0|0.307|0.581|||Regression, Logistic||Model: Treatment + Site|||0.581|0.307|<0.001
72616489|NCT00309244|144763716|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.409||||0.0066|TWO_SIDED|95.0|0.215|0.78|||Regression, Logistic||Model: Treatment + Site|||0.780|0.215|0.0066
72616490|NCT00309244|144763717|SUPERIORITY_OR_OTHER|||||||0.0027|||||||Generalized Estimation Equation|Based on Poisson distribution||||||0.0027
72616491|NCT00309244|144763718|SUPERIORITY_OR_OTHER|||||||0.0591|||||||Generalized Estimating Equation|Based on Poission distribution||||||0.0591
72616492|NCT03019588|144763724|SUPERIORITY||Hazard Ratio (HR)|0.89||||0.29|TWO_SIDED|95.0|0.58|1.36|||Log Rank|One-sided p-value based on log-rank test stratified by time to progression on first line therapy (\< 6 months vs. ≥ 6 months) and ECOG PS (0 vs. 1).|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by time to progression on first line therapy (\< 6 months vs. ≥ 6 months) and ECOG PS (0 vs. 1).|||1.36|0.58|0.2900
72616493|NCT03019588|144763725|SUPERIORITY||Hazard Ratio (HR)|1.77||||0.9954|TWO_SIDED|95.0|1.14|2.74|||Log Rank|One-sided p-value based on log-rank test stratified by time to progression on first line therapy (\< 6 months vs. ≥ 6 months) and ECOG PS (0 vs. 1).|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by time to progression on first line therapy (\< 6 months vs. ≥ 6 months) and ECOG PS (0 vs. 1).|||2.74|1.14|0.9954
72616494|NCT03019588|144763726|SUPERIORITY||Difference in percentage|-6.0||||0.7884|TWO_SIDED|95.0|-21.6|9.3|||Z-test|One-sided p-value for testing. H0: difference in % = 0 versus H1: difference in % \> 0.|Based on Miettinen \& Nurminen method stratified by time to progression on first line therapy (\< 6 months vs. ≥ 6 months) and ECOG PS (0 vs. 1).|||9.3|-21.6|0.7884
72616495|NCT00106535|144763754|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Cochran-Mantel-Haenszel|||||||<0.0001
72616496|NCT00106535|144763754|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Cochran-Mantel-Haenszel|||||||<0.0001
72616497|NCT00106535|144763755|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Cochran-Mantel-Haenszel|||||||<0.0001
72616498|NCT00106535|144763755|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Cochran-Mantel-Haenszel|||||||<0.0001
72371587|NCT00669409|144253443|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-25.0|STANDARD_ERROR_OF_MEAN|10.48|||TWO_SIDED|95.0|-45.8|-4.3||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-4.3|-45.8|
72616499|NCT00106535|144763756|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Cochran-Mantel-Haenszel|||||||<0.0001
72616500|NCT00106535|144763756|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Cochran-Mantel-Haenszel|||||||<0.0001
72616501|NCT00106535|144763765|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Van Elteren's test|Stratified by region.||||||<0.0001
72616502|NCT00106535|144763765|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Van Elteren's test|Stratified by region.||||||<0.0001
72432378|NCT02696785|144377174|SUPERIORITY||LSMean Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.56||0.154|TWO_SIDED|95.0|-1.9|0.3|||Mixed Models Analysis|||||0.3|-1.9|0.154
72616503|NCT00106535|144763766|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-70.26|||<|0.0001|TWO_SIDED|95.0|-96.96|-43.56|||ANOVA|Adjusted for region and original treatment group.||||-43.56|-96.96|<0.0001
72616504|NCT00106535|144763766|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-85.95|||<|0.0001|TWO_SIDED|95.0|-112.69|-59.22|||ANOVA|Adjusted for region and original treatment group.||||-59.22|-112.69|<0.0001
72616505|NCT00106535|144763768|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-148.1|||<|0.0001|TWO_SIDED|95.0|-205.22|-90.98|||ANOVA|Adjusted for region.||||-90.98|-205.22|<0.0001
72616506|NCT00106535|144763768|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-181.4|||<|0.0001|TWO_SIDED|95.0|-238.6|-124.21|||ANOVA|Adjusted for region.||||-124.21|-238.60|<0.0001
72616507|NCT00106535|144763793|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5212.28|||<|0.0001|TWO_SIDED|95.0|3139.4|7285.16|||ANOVA|Adjusted for region.||||7285.16|3139.40|<0.0001
72616508|NCT00106535|144763793|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7092.76|||<|0.0001|TWO_SIDED|95.0|5066.16|9119.36||Adjusted for region.|ANOVA|||||9119.36|5066.16|<0.0001
72616509|NCT00106535|144763809|SUPERIORITY_OR_OTHER|||||||0.0023||95.0|||||Van Elteren's test|Stratified by region.||||||0.0023
72616510|NCT00106535|144763809|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Van Elteren's test|||||||<0.0001
72555015|NCT03086460|144641770|SUPERIORITY||Mean Difference (Final Values)|0.184|||<|0.001|TWO_SIDED|95.0|0.125|0.243|||ANCOVA|||"Day 14~Comparison groups were:~Treatment F ( Perforomist® IS 40 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.243|0.125|<0.001
72555016|NCT03086460|144641770|SUPERIORITY||Mean Difference (Final Values)|0.027||||0.4|TWO_SIDED|95.0|-0.036|0.09|||ANCOVA|||"Day 14~Comparison groups were:~Treatment B (CHF 1531 pMDI 12 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.090|-0.036|0.400
72555017|NCT03086460|144641770|SUPERIORITY||Mean Difference (Final Values)|0.003||||0.931|TWO_SIDED|95.0|-0.059|0.064|||ANCOVA|||"Day 14~Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.064|-0.059|0.931
72555018|NCT03086460|144641770|SUPERIORITY||Mean Difference (Final Values)|0.043||||0.16|TWO_SIDED|95.0|-0.017|0.102|||ANCOVA|||"Day 14~Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.102|-0.017|0.160
72555019|NCT03086460|144641770|SUPERIORITY||Mean Difference (Final Values)|-0.024||||0.464|TWO_SIDED|95.0|-0.09|0.041|||ANCOVA|||"Day 14~Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment B (CHF 1531 pMDI 12 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.041|-0.090|0.464
72555020|NCT03086460|144641770|SUPERIORITY||Mean Difference (Final Values)|0.016||||0.623|TWO_SIDED|95.0|-0.047|0.078|||ANCOVA|||"Day 14~Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment B (CHF 1531 pMDI 12 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.078|-0.047|0.623
72555021|NCT03086460|144641770|SUPERIORITY||Mean Difference (Final Values)|0.04||||0.197|TWO_SIDED|95.0|-0.021|0.101|||ANCOVA|||"Day 14~Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment C (CHF 1531 pMDI 24 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.101|-0.021|0.197
72555022|NCT03086460|144641771|SUPERIORITY||Mean Difference (Final Values)|0.052||||0.098|TWO_SIDED|95.0|-0.01|0.113|||ANCOVA|||"Day 1~Comparison groups were:~Treatment A (CHF 1531 pMDI 6 μg TDD) versus Treatment E (Placebo).~This secondary efficacy variable was analyzed using the ANCOVA model that was also used for the primary efficacy analysis, without adjusting for multiplicity."||0.113|-0.010|0.098
72555023|NCT03086460|144641771|SUPERIORITY||Mean Difference (Final Values)|0.097||||0.002|TWO_SIDED|95.0|0.035|0.159|||ANCOVA|||"Day 1~Comparison groups were:~Treatment B (CHF 1531 pMDI 12 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.159|0.035|0.002
72555024|NCT03086460|144641771|SUPERIORITY||Mean Difference (Final Values)|0.101||||0.002|TWO_SIDED|95.0|0.039|0.163|||ANCOVA|||"Day 1~Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.163|0.039|0.002
72555025|NCT03086460|144641771|SUPERIORITY||Mean Difference (Final Values)|0.122|||<|0.001|TWO_SIDED|95.0|0.063|0.182|||ANCOVA|||"Day 1~Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.182|0.063|<0.001
72555026|NCT03086460|144641771|SUPERIORITY||Mean Difference (Final Values)|0.112|||<|0.001|TWO_SIDED|95.0|0.054|0.171|||ANCOVA|||"Day 1~Comparison groups were:~Treatment F ( Perforomist® IS 40 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.171|0.054|<0.001
72555027|NCT03086460|144641771|SUPERIORITY||Mean Difference (Final Values)|0.045||||0.162|TWO_SIDED|95.0|-0.018|0.108|||ANCOVA|||"Day 1~Comparison groups were:~Treatment B (CHF 1531 pMDI 12 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.108|-0.018|0.162
72555028|NCT03086460|144641771|SUPERIORITY||Mean Difference (Final Values)|0.049||||0.117|TWO_SIDED|95.0|-0.012|0.11|||ANCOVA|||"Day 1~Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.110|-0.012|0.117
72555029|NCT03086460|144641771|SUPERIORITY||Mean Difference (Final Values)|0.071||||0.02|TWO_SIDED|95.0|0.011|0.13|||ANCOVA|||"Day 1~Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.130|0.011|0.020
72555030|NCT03086460|144641771|SUPERIORITY||Mean Difference (Final Values)|0.004||||0.909|TWO_SIDED|95.0|-0.062|0.07|||ANCOVA|||"Day 1~Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment B (CHF 1531 pMDI 12 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.070|-0.062|0.909
72555031|NCT03086460|144641771|SUPERIORITY||Mean Difference (Final Values)|0.025||||0.419|TWO_SIDED|95.0|-0.037|0.088|||ANCOVA|||"Day 1~Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment B (CHF 1531 pMDI 12 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.088|-0.037|0.419
72555032|NCT03086460|144641771|SUPERIORITY||Mean Difference (Final Values)|0.022||||0.483|TWO_SIDED|95.0|-0.039|0.083|||ANCOVA|||"Day 1~Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment C (CHF 1531 pMDI 24 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.083|-0.039|0.483
72555033|NCT03086460|144641771|SUPERIORITY||Mean Difference (Final Values)|0.043||||0.126|TWO_SIDED|95.0|-0.012|0.099|||ANCOVA|||"Day 14~Comparison groups were:~Treatment A (CHF 1531 pMDI 6 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.099|-0.012|0.126
72616511|NCT00106535|144763810|SUPERIORITY_OR_OTHER|||||||0.0001||95.0|||||Van Elteren's test|Stratified by region.||||||0.0001
72616512|NCT00106535|144763810|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Van Elteren's test|Stratified by region.||||||<0.0001
72371588|NCT00669409|144253444|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|6.7|STANDARD_ERROR_OF_MEAN|7.98|||TWO_SIDED|95.0|-9.1|22.5||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||22.5|-9.1|
72371589|NCT00669409|144253444|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-16.0|STANDARD_ERROR_OF_MEAN|7.98|||TWO_SIDED|95.0|-31.7|-0.2||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-0.2|-31.7|
72371590|NCT00669409|144253444|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-2.6|STANDARD_ERROR_OF_MEAN|7.99|||TWO_SIDED|95.0|-18.5|13.2||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||13.2|-18.5|
72371591|NCT00669409|144253444|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-10.3|STANDARD_ERROR_OF_MEAN|7.88|||TWO_SIDED|95.0|-25.9|5.3||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||5.3|-25.9|
72371592|NCT00669409|144253444|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-23.5|STANDARD_ERROR_OF_MEAN|10.48|||TWO_SIDED|95.0|-44.2|-2.7||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-2.7|-44.2|
72371593|NCT00669409|144253445|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|11.2|STANDARD_ERROR_OF_MEAN|7.98|||TWO_SIDED|95.0|-4.6|27.0||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||27.0|-4.6|
72371594|NCT00669409|144253445|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-14.2|STANDARD_ERROR_OF_MEAN|7.98|||TWO_SIDED|95.0|-30.0|1.5||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||1.5|-30.0|
72371595|NCT00669409|144253445|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|1.5|STANDARD_ERROR_OF_MEAN|7.99|||TWO_SIDED|95.0|-14.3|17.3||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||17.3|-14.3|
72371596|NCT00669409|144253445|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-6.3|STANDARD_ERROR_OF_MEAN|7.88|||TWO_SIDED|95.0|-21.9|9.3||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||9.3|-21.9|
72371597|NCT00669409|144253445|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-19.8|STANDARD_ERROR_OF_MEAN|10.48|||TWO_SIDED|95.0|-40.5|1.0||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||1.0|-40.5|
72371598|NCT00669409|144253446|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|10.8|STANDARD_ERROR_OF_MEAN|7.98|||TWO_SIDED|95.0|-5.0|26.6||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||26.6|-5.0|
72493522|NCT00699907|144516265|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Wilcoxon Rank Sum Test|||||||>0.05
72371599|NCT00669409|144253446|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-14.2|STANDARD_ERROR_OF_MEAN|7.98|||TWO_SIDED|95.0|-30.0|1.6||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||1.6|-30.0|
72371600|NCT00669409|144253446|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|1.2|STANDARD_ERROR_OF_MEAN|7.99|||TWO_SIDED|95.0|-14.6|17.0||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||17.0|-14.6|
72371601|NCT00669409|144253446|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-5.4|STANDARD_ERROR_OF_MEAN|7.88|||TWO_SIDED|95.0|-21.0|10.2||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||10.2|-21.0|
72432379|NCT02696785|144377174|SUPERIORITY||LSMean Difference|0.255|STANDARD_ERROR_OF_MEAN|0.56||-0.6|TWO_SIDED|95.0|-1.8|0.5|||Mixed Models Analysis|||||0.5|-1.8|-0.6
72493523|NCT00699907|144516266|SUPERIORITY_OR_OTHER|||||||0.006|||||||Wilcoxon Rank Sum Test|||||||0.006
72493524|NCT00699907|144516266|SUPERIORITY_OR_OTHER|||||||0.005|||||||Wilcoxon Rank Sum Test|||||||0.005
72493525|NCT00699907|144516267|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Rank Sum Test|||||||<0.0001
72493526|NCT00699907|144516267|SUPERIORITY_OR_OTHER|||||||0.005|||||||Wilcoxon Rank Sum Test|||||||0.005
72493527|NCT01097304|144516287|OTHER|||||||0.54|||||||t-test, 2 sided|||||||0.54
72493528|NCT01097304|144516288|OTHER||||||<|0.0001|||||||signed rank test|||||||<0.0001
72493529|NCT01097304|144516289|OTHER||||||<|0.01|||||||signed rank test|||||||<0.01
72493530|NCT01097304|144516290|OTHER|||||||0.48|||||||t-test, 2 sided|||||||0.48
72616513|NCT06100250|144763877|OTHER|Paired sample t-test, 2 sided|Mean Difference (Net)|0.82||||0.01|TWO_SIDED|||||A priori threshold for statistical significance = 0.05|Paired sample t-test, 2 sided|Degrees of freedom = 66|Estimation parameter represents the average of the differences between the paired observations (post-intervention score minus pre-intervention score)|Null hypothesis = Mean difference between the paired STI-related knowledge scores (pre-intervention and post-intervention) is 0||||0.01
72616514|NCT06100250|144763879|OTHER|Paired sample t-test, 2 sided|Mean Difference (Net)|-1.29|||<|0.01|TWO_SIDED|||||A priori threshold for statistical significance = 0.05|Paired sample t-test, 2 sided|Degrees of freedom = 47|Estimation parameter represents the average of the differences between the paired observations (post-intervention score minus pre-intervention score)|Null hypothesis = Mean difference between the paired self-efficacy for specimen self-collection scores (pre-intervention and post-intervention) is 0||||<0.01
72616515|NCT02021318|144763882|NON_INFERIORITY|Non-inferiority of roxadustat versus darbepoetin alfa, margin = -15% (non-inferiority is concluded if the lower limit of the 95% confidence interval of the difference was \>-15%).|Difference in percentage|11.51|||||TWO_SIDED|95.0|5.66|17.36||||||A generalized linear model as an approximation for the Miettinen and Nurminen method, adjusted for stratification factors (actual) was used to estimate the difference of proportions and 95% confidence interval.||17.36|5.66|
72616516|NCT02021318|144763883|NON_INFERIORITY|Non-Inferiority, margin = -0.75 (non-inferiority is concluded if the lower bound of the 95% CI of the least square mean difference (LSM) is \> -0.75 g/dL).|LSM Difference|0.015||||0.839|TWO_SIDED|95.0|-0.131|0.162|||Mixed Models Analysis|||The model included treatment, visit, visit by treatment interaction, region and history of cardiovascular disease as fixed class factors and baseline Hb, baseline estimated glomerular filtration rate and baseline Hb by visit as continuous covariates.||0.162|-0.131|0.839
72616517|NCT02021318|144763884|SUPERIORITY||LSM Difference|-0.403|||<|0.001|TWO_SIDED|95.0|-0.51|-0.296|||Mixed Models Analysis|||The model included treatment, visit, visit by treatment interaction, region and history of cardiovascular disease as fixed class factors and baseline LDL, baseline Hb, baseline estimated glomerular filtration rate as continuous covariates.||-0.296|-0.510|<0.001
72616518|NCT02021318|144763885|SUPERIORITY||Hazard Ratio (HR)|0.45||||0.004|TWO_SIDED|95.0|0.26|0.78|||Regression, Cox|||Hazard Ratio was calculated using stratified Cox Proportional Hazards regression stratifying on cardiovascular history and region and adjusting on Hb and eGFR at baseline as continuous covariate. Superiority was declared if the upper bound of the 95% CI was below 1.0.||0.78|0.26|0.004
72616519|NCT02021318|144763886|NON_INFERIORITY|Non-Inferiority, margin = -3 (non-inferiority is concluded if the lower bound of the 95% confidence interval of the LSM difference is \> -3 points).|LSM Difference|-1.284||||0.027|TWO_SIDED|95.0|-2.423|-0.145|||Mixed Models Analysis|||The model included treatment, visit (weeks 8, 12 and 28) visit by treatment interaction, region and history of cardiovascular disease as fixed class factors and baseline SF-36 PF, baseline Hb, baseline estimated glomerular filtration rate as continuous covariates.||-0.145|-2.423|0.027
72616520|NCT02021318|144763887|NON_INFERIORITY|Non-Inferiority, margin = -3 (non-inferiority is concluded if the lower bound of the 95% confidence interval of the LSM difference is \> -3 points).|LSM Difference|-0.457||||0.454|TWO_SIDED|95.0|-1.656|0.742|||Mixed Models Analysis|||The model included treatment, visit (weeks 8, 12 and 28), visit by treatment interaction, region and history of cardiovascular disease as fixed class factors and baseline SF-36 VT, baseline Hb, baseline eGFR as continuous covariates.||0.742|-1.656|0.454
72616521|NCT02021318|144763888|NON_INFERIORITY|Non-Inferiority, margin = 1 mmHg (non-inferiority is concluded if the upper bound of the 95% confidence interval of the LSM difference is \< 1).|LSM Difference|-0.372||||0.547|TWO_SIDED|95.0|-1.587|0.842|||Mixed Models Analysis|||The model included treatment, visit, visit by treatment interaction, region and history of CV disease as fixed class factors and baseline MAP, baseline Hb, baseline eGFR as continuous covariates.||0.842|-1.587|0.547
72616522|NCT02021318|144763889|NON_INFERIORITY|Non-inferiority (hazard ratio margin of 1.3). Non-Inferiority was declared if the upper bound of the 95% CI is below 1.3.|Hazard Ratio (HR)|0.83||||0.336|TWO_SIDED|95.0|0.56|1.22|||Regression, Cox|||Hazard Ratio was calculated using stratified Cox Proportional Hazards regression stratifying on CV history and Region and adjusting on Hb and eGFR at baseline as continuous covariates.||1.22|0.56|0.336
72616523|NCT02021318|144763890|SUPERIORITY||LSM Difference|-0.136||||0.818|TWO_SIDED|95.0|-1.299|1.026|||Mixed Models Analysis|||The model included treatment, visit, visit by treatment interaction, region and history of cardiovascular disease as fixed class factors and baseline MAP, baseline Hb, baseline eGFR as continuous covariates.||1.026|-1.299|0.818
72616524|NCT02021318|144763891|SUPERIORITY||Hazard Ratio (HR)|0.87||||0.452|TWO_SIDED|95.0|0.6|1.26|||Regression, Cox|||Hazard Ratio was calculated using stratified Cox Proportional Hazards regression stratifying on cardiovascular history and region and adjusting on Hb and eGFR at baseline as continuous covariates. Superiority was declared if the upper bound of the 95% CI is lower than 1.||1.26|0.60|0.452
72616525|NCT02021318|144763892|SUPERIORITY||LSM Difference|0.038||||0.529|TWO_SIDED|95.0|-0.081|0.157|||Mixed Models Analysis|||The model included treatment, visit, visit by treatment interaction, region and history of cardiovascular disease as fixed class factors and baseline Hb, baseline eGFR and baseline Hb by visit as continuous covariates.||0.157|-0.081|0.529
72616526|NCT02021318|144763893|SUPERIORITY||Hazard Ratio (HR)|1.64|||<|0.001|TWO_SIDED|95.0|1.38|1.96|||Regression, Cox|||Hazard Ratio was calculated using stratified Cox Proportional Hazards regression stratifying on cardiovascular history and region and adjusting on Hb and eGFR at baseline as continuous covariates.||1.96|1.38|<0.001
72616527|NCT02021318|144763894|SUPERIORITY||Hazard Ratio (HR)|1.66|||<|0.001|TWO_SIDED|95.0|1.39|1.98|||Regression, Cox|||Hazard ratio was calculated using stratified Cox Proportional Hazards regression stratifying on CV history and region and adjusting on Hb and eGFR at baseline as continuous covariates.||1.98|1.39|<0.001
72493531|NCT03850912|144516291|SUPERIORITY||Odds Ratio (OR)|1.104||||0.214|TWO_SIDED|95.0|0.944|1.29|||Regression, Logistic|||Adjusted analysis comparing control versus intervention patients (chemo and surgical patients combined)||1.290|0.944|0.214
72432380|NCT02696785|144377174|SUPERIORITY||LSMean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.58||0.398|TWO_SIDED|95.0|-1.6|0.7|||Mixed Models Analysis|||||0.7|-1.6|0.398
72616528|NCT02021318|144763895|SUPERIORITY||LSM Difference|0.051||||0.478|TWO_SIDED|95.0|-0.091|0.194|||Mixed Models Analysis|||Weeks 28-36 - The model included treatment, visit, visit by treatment interaction, region and history of CV disease as fixed class factors and baseline Hb, baseline estimated glomerular filtration rate and baseline Hb by visit as continuous covariates.||0.194|-0.091|0.478
72616529|NCT02021318|144763895|SUPERIORITY||LSM Difference|-0.003||||0.969|TWO_SIDED|95.0|-0.149|0.143|||Mixed Models Analysis|||Weeks 44-52 - The model included treatment, visit, visit by treatment interaction, region and history of CV disease as fixed class factors and baseline Hb, baseline estimated glomerular filtration rate and baseline Hb by visit as continuous covariates.||0.143|-0.149|0.969
72616530|NCT02021318|144763895|SUPERIORITY||LSM Difference|0.009||||0.91|TWO_SIDED|95.0|-0.14|0.157|||Mixed Models Analysis|||Weeks 72-80 - The model included treatment, visit, visit by treatment interaction, region and history of CV disease as fixed class factors and baseline Hb, baseline estimated glomerular filtration rate and baseline Hb by visit as continuous covariates.||0.157|-0.140|0.910
72616531|NCT02021318|144763895|SUPERIORITY||LSM Difference|0.024||||0.775|TWO_SIDED|95.0|-0.14|0.188|||Mixed Models Analysis|||Weeks 96-104 - The model included treatment, visit, visit by treatment interaction, region and history of CV disease as fixed class factors and baseline Hb, baseline estimated glomerular filtration rate and baseline Hb by visit as continuous covariates.||0.188|-0.140|0.775
72616532|NCT02021318|144763896|SUPERIORITY||LSM Difference|0.087||||0.086|TWO_SIDED|95.0|-0.012|0.185|||Mixed Models Analysis|||Week 1- The model included treatment, visit, visit by treatment interaction, region and history of CV disease as fixed class factors and baseline Hb, baseline eGFR and baseline Hb by visit as continuous covariates.||0.185|-0.012|0.086
72616533|NCT02021318|144763896|SUPERIORITY||LSM Difference|0.278|||<|0.001|TWO_SIDED|95.0|0.165|0.391|||Mixed Models Analysis|||Week 2- The model included treatment, visit, visit by treatment interaction, region and history of CV disease as fixed class factors and baseline Hb, baseline eGFR and baseline Hb by visit as continuous covariates.||0.391|0.165|<0.001
72616534|NCT02021318|144763896|SUPERIORITY||LSM Difference|0.435|||<|0.001|TWO_SIDED|95.0|0.284|0.586|||Mixed Models Analysis|||Week 4- The model included treatment, visit, visit by treatment interaction, region and history of CV disease as fixed class factors and baseline Hb, baseline eGFR and baseline Hb by visit as continuous covariates.||0.586|0.284|<0.001
72616535|NCT02021318|144763896|SUPERIORITY||LSM Difference|0.422|||<|0.001|TWO_SIDED|95.0|0.254|0.59|||Mixed Models Analysis|||Week 6- The model included treatment, visit, visit by treatment interaction, region and history of CV disease as fixed class factors and baseline Hb, baseline eGFR and baseline Hb by visit as continuous covariates.||0.590|0.254|<0.001
72616536|NCT02021318|144763896|SUPERIORITY||LSM Difference|0.38|||<|0.001|TWO_SIDED|95.0|0.205|0.556|||Mixed Models Analysis|||Week 8- The model included treatment, visit, visit by treatment interaction, region and history of CV disease as fixed class factors and baseline Hb, baseline eGFR and baseline Hb by visit as continuous covariates.||0.556|0.205|<0.001
72616537|NCT02021318|144763896|SUPERIORITY||LSM Difference|0.33|||<|0.001|TWO_SIDED|95.0|0.155|0.505|||Mixed Models Analysis|||Week 10- The model included treatment, visit, visit by treatment interaction, region and history of CV disease as fixed class factors and baseline Hb, baseline eGFR and baseline Hb by visit as continuous covariates.||0.505|0.155|<0.001
72616538|NCT02021318|144763896|SUPERIORITY||LSM Difference|0.3||||0.001|TWO_SIDED|95.0|0.119|0.482|||Mixed Models Analysis|||Week 12- The model included treatment, visit, visit by treatment interaction, region and history of CV disease as fixed class factors and baseline Hb, baseline eGFR and baseline Hb by visit as continuous covariates.||0.482|0.119|0.001
72493532|NCT03850912|144516291|SUPERIORITY||Odds Ratio (OR)|0.927||||0.565|TWO_SIDED|95.0|0.715|1.201|||Regression, Logistic|||Adjusted analysis comparing control versus intervention patients (medical oncology patients only)||1.201|0.715|0.565
72616539|NCT02021318|144763896|SUPERIORITY||LSM Difference|0.159||||0.079|TWO_SIDED|95.0|-0.018|0.336|||Mixed Models Analysis|||Week 14- The model included treatment, visit, visit by treatment interaction, region and history of CV disease as fixed class factors and baseline Hb, baseline eGFR and baseline Hb by visit as continuous covariates.||0.336|-0.018|0.079
72616540|NCT02021318|144763896|SUPERIORITY||LSM Difference|0.183||||0.044|TWO_SIDED|95.0|0.005|0.361|||Mixed Models Analysis|||Week 16- The model included treatment, visit, visit by treatment interaction, region and history of CV disease as fixed class factors and baseline Hb, baseline eGFR and baseline Hb by visit as continuous covariates.||0.361|0.005|0.044
72616541|NCT02021318|144763896|SUPERIORITY||LSM Difference|0.173||||0.037|TWO_SIDED|95.0|0.01|0.336|||Mixed Models Analysis|||Week 18- The model included treatment, visit, visit by treatment interaction, region and history of CV disease as fixed class factors and baseline Hb, baseline eGFR and baseline Hb by visit as continuous covariates.||0.336|0.010|0.037
72616542|NCT02021318|144763896|SUPERIORITY||LSM Difference|0.085||||0.319|TWO_SIDED|95.0|-0.083|0.253|||Mixed Models Analysis|||Week 20- The model included treatment, visit, visit by treatment interaction, region and history of CV disease as fixed class factors and baseline Hb, baseline eGFR and baseline Hb by visit as continuous covariates.||0.253|-0.083|0.319
72616543|NCT02021318|144763896|SUPERIORITY||LSM Difference|-0.03||||0.709|TWO_SIDED|95.0|-0.19|0.129|||Mixed Models Analysis|||Week 22- The model included treatment, visit, visit by treatment interaction, region and history of CV disease as fixed class factors and baseline Hb, baseline eGFR and baseline Hb by visit as continuous covariates.||0.129|-0.190|0.709
72616544|NCT02021318|144763896|SUPERIORITY||LSM Difference|-0.061||||0.45|TWO_SIDED|95.0|-0.219|0.097|||Mixed Models Analysis|||Week 24- The model included treatment, visit, visit by treatment interaction, region and history of CV disease as fixed class factors and baseline Hb, baseline eGFR and baseline Hb by visit as continuous covariates.||0.097|-0.219|0.450
72493533|NCT03850912|144516291|SUPERIORITY||Odds Ratio (OR)|1.225||||0.042|TWO_SIDED|95.0|1.008|1.49|||Regression, Logistic|||Adjusted analysis comparing control versus intervention patients (surgical patients only)||1.490|1.008|0.042
72493534|NCT03850912|144516292|OTHER||Odds Ratio (OR)|1.128||||0.05|TWO_SIDED|95.0|1.0|1.272|||Regression, Logistic|||Adjusted analysis comparing control versus intervention patients (medical oncology and surgical patients combined)||1.272|1.000|0.050
72493535|NCT03850912|144516292|OTHER||Odds Ratio (OR)|1.012||||0.903|TWO_SIDED|95.0|0.836|1.225|||Regression, Logistic|||Adjusted analysis comparing control versus intervention patients (medical oncology patients only)||1.225|0.836|0.903
72432381|NCT02696785|144377175|SUPERIORITY||LSMean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.76||0.783|TWO_SIDED|95.0|-1.7|1.3|||Mixed Models Analysis|||||1.3|-1.7|0.783
72616545|NCT02021318|144763896|SUPERIORITY||LSM Difference|-0.065||||0.44|TWO_SIDED|95.0|-0.231|0.101|||Mixed Models Analysis|||Week 28- The model included treatment, visit, visit by treatment interaction, region and history of CV disease as fixed class factors and baseline Hb, baseline eGFR and baseline Hb by visit as continuous covariates.||0.101|-0.231|0.440
72616546|NCT02021318|144763896|SUPERIORITY||LSM Difference|0.014||||0.874|TWO_SIDED|95.0|-0.157|0.184|||Mixed Models Analysis|||Week 32- The model included treatment, visit, visit by treatment interaction, region and history of CV disease as fixed class factors and baseline Hb, baseline eGFR and baseline Hb by visit as continuous covariates.||0.184|-0.157|0.874
72616547|NCT02021318|144763896|SUPERIORITY||LSM Difference|0.131||||0.132|TWO_SIDED|95.0|-0.039|0.302|||Mixed Models Analysis|||Week 36- The model included treatment, visit, visit by treatment interaction, region and history of CV disease as fixed class factors and baseline Hb, baseline eGFR and baseline Hb by visit as continuous covariates.||0.302|-0.039|0.132
72616548|NCT02021318|144763896|SUPERIORITY||LSM Difference|0.187||||0.024|TWO_SIDED|95.0|0.024|0.351|||Mixed Models Analysis|||Week 40- The model included treatment, visit, visit by treatment interaction, region and history of CV disease as fixed class factors and baseline Hb, baseline eGFR and baseline Hb by visit as continuous covariates.||0.351|0.024|0.024
72616549|NCT02021318|144763896|SUPERIORITY||LSM Difference|0.022||||0.807|TWO_SIDED|95.0|-0.153|0.197|||Mixed Models Analysis|||Week 44- The model included treatment, visit, visit by treatment interaction, region and history of CV disease as fixed class factors and baseline Hb, baseline eGFR and baseline Hb by visit as continuous covariates.||0.197|-0.153|0.807
72616550|NCT02021318|144763896|SUPERIORITY||LSM Difference|0.012||||0.89|TWO_SIDED|95.0|-0.16|0.185|||Mixed Models Analysis|||Week 48- The model included treatment, visit, visit by treatment interaction, region and history of CV disease as fixed class factors and baseline Hb, baseline eGFR and baseline Hb by visit as continuous covariates.||0.185|-0.160|0.890
72616551|NCT02021318|144763896|SUPERIORITY||LSM Difference|-0.029||||0.746|TWO_SIDED|95.0|-0.201|0.144|||Mixed Models Analysis|||Week 52- The model included treatment, visit, visit by treatment interaction, region and history of CV disease as fixed class factors and baseline Hb, baseline eGFR and baseline Hb by visit as continuous covariates.||0.144|-0.201|0.746
72616552|NCT02021318|144763896|SUPERIORITY||LSM Difference|-0.032||||0.715|TWO_SIDED|95.0|-0.202|0.139|||Mixed Models Analysis|||Week 56- The model included treatment, visit, visit by treatment interaction, region and history of CV disease as fixed class factors and baseline Hb, baseline eGFR and baseline Hb by visit as continuous covariates.||0.139|-0.202|0.715
72616553|NCT02021318|144763896|SUPERIORITY||LSM Difference|0.066||||0.463|TWO_SIDED|95.0|-0.11|0.242|||Mixed Models Analysis|||Week 60- The model included treatment, visit, visit by treatment interaction, region and history of CV disease as fixed class factors and baseline Hb, baseline eGFR and baseline Hb by visit as continuous covariates.||0.242|-0.110|0.463
72616554|NCT02021318|144763896|SUPERIORITY||LSM Difference|-0.002||||0.987|TWO_SIDED|95.0|-0.187|0.184|||Mixed Models Analysis|||Week 64- The model included treatment, visit, visit by treatment interaction, region and history of CV disease as fixed class factors and baseline Hb, baseline eGFR and baseline Hb by visit as continuous covariates.||0.184|-0.187|0.987
72616555|NCT02021318|144763896|SUPERIORITY||LSM Difference|0.104||||0.251|TWO_SIDED|95.0|-0.074|0.281|||Mixed Models Analysis|||Week 68- The model included treatment, visit, visit by treatment interaction, region and history of CV disease as fixed class factors and baseline Hb, baseline eGFR and baseline Hb by visit as continuous covariates.||0.281|-0.074|0.251
72616556|NCT02021318|144763896|SUPERIORITY||LSM Difference|0.067||||0.473|TWO_SIDED|95.0|-0.117|0.251|||Mixed Models Analysis|||Week 72- The model included treatment, visit, visit by treatment interaction, region and history of CV disease as fixed class factors and baseline Hb, baseline eGFR and baseline Hb by visit as continuous covariates.||0.251|-0.117|0.473
72616557|NCT02021318|144763896|SUPERIORITY||LSM Difference|-0.022||||0.813|TWO_SIDED|95.0|-0.204|0.16|||Mixed Models Analysis|||Week 76- The model included treatment, visit, visit by treatment interaction, region and history of CV disease as fixed class factors and baseline Hb, baseline eGFR and baseline Hb by visit as continuous covariates.||0.160|-0.204|0.813
72616558|NCT02021318|144763896|SUPERIORITY||LSM Difference|-0.045||||0.622|TWO_SIDED|95.0|-0.223|0.134|||Mixed Models Analysis|||Week 80- The model included treatment, visit, visit by treatment interaction, region and history of CV disease as fixed class factors and baseline Hb, baseline eGFR and baseline Hb by visit as continuous covariates.||0.134|-0.223|0.622
72616559|NCT02021318|144763896|SUPERIORITY||LSM Difference|0.045||||0.632|TWO_SIDED|95.0|-0.138|0.227|||Mixed Models Analysis|||Week 84- The model included treatment, visit, visit by treatment interaction, region and history of CV disease as fixed class factors and baseline Hb, baseline eGFR and baseline Hb by visit as continuous covariates.||0.227|-0.138|0.632
72616560|NCT02021318|144763896|SUPERIORITY||LSM Difference|0.055||||0.568|TWO_SIDED|95.0|-0.133|0.242|||Mixed Models Analysis|||Week 88- The model included treatment, visit, visit by treatment interaction, region and history of CV disease as fixed class factors and baseline Hb, baseline eGFR and baseline Hb by visit as continuous covariates.||0.242|-0.133|0.568
72616561|NCT02021318|144763896|SUPERIORITY||LSM Difference|0.034||||0.729|TWO_SIDED|95.0|-0.158|0.226|||Mixed Models Analysis|||Week 92- The model included treatment, visit, visit by treatment interaction, region and history of CV disease as fixed class factors and baseline Hb, baseline eGFR and baseline Hb by visit as continuous covariates.||0.226|-0.158|0.729
72616562|NCT02021318|144763896|SUPERIORITY||LSM Difference|0.025||||0.797|TWO_SIDED|95.0|-0.168|0.218|||Mixed Models Analysis|||Week 96- The model included treatment, visit, visit by treatment interaction, region and history of CV disease as fixed class factors and baseline Hb, baseline eGFR and baseline Hb by visit as continuous covariates.||0.218|-0.168|0.797
72371602|NCT00669409|144253446|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-14.6|STANDARD_ERROR_OF_MEAN|10.48|||TWO_SIDED|95.0|-35.3|6.2||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||6.2|-35.3|
72432382|NCT02696785|144377175|SUPERIORITY||LSMean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.78||0.55|TWO_SIDED|95.0|-2.0|1.1|||Mixed Models Analysis|||||1.1|-2.0|0.550
72616563|NCT02021318|144763896|SUPERIORITY||LSM Difference|-0.11||||0.28|TWO_SIDED|95.0|-0.31|0.09|||Mixed Models Analysis|||Week 100- The model included treatment, visit, visit by treatment interaction, region and history of CV disease as fixed class factors and baseline Hb, baseline eGFR and baseline Hb by visit as continuous covariates.||0.090|-0.310|0.280
72616564|NCT02021318|144763896|SUPERIORITY||LSM Difference|0.037||||0.733|TWO_SIDED|95.0|-0.177|0.251|||Mixed Models Analysis|||Week 104- The model included treatment, visit, visit by treatment interaction, region and history of CV disease as fixed class factors and baseline Hb, baseline eGFR and baseline Hb by visit as continuous covariates.||0.251|-0.177|0.733
72616565|NCT02021318|144763897|SUPERIORITY||LSM Difference|0.026||||0.727|TWO_SIDED|95.0|-0.119|0.17|||Mixed Models Analysis|||Weeks 28-36 - The model included treatment, visit, visit by treatment interaction, region and history of CV disease as fixed class factors and baseline Hb, baseline estimated glomerular filtration rate and baseline Hb by visit as continuous covariates.||0.170|-0.119|0.727
72616566|NCT02021318|144763897|SUPERIORITY||LSM Difference|-0.001||||0.985|TWO_SIDED|95.0|-0.151|0.148|||Mixed Models Analysis|||Weeks 44-52 - The model included treatment, visit, visit by treatment interaction, region and history of CV disease as fixed class factors and baseline Hb, baseline estimated glomerular filtration rate and baseline Hb by visit as continuous covariates.||0.148|-0.151|0.985
72616567|NCT02021318|144763897|SUPERIORITY||LSM Difference|0.003||||0.965|TWO_SIDED|95.0|-0.148|0.154|||Mixed Models Analysis|||Weeks 72-80 - The model included treatment, visit, visit by treatment interaction, region and history of CV disease as fixed class factors and baseline Hb, baseline estimated glomerular filtration rate and baseline Hb by visit as continuous covariates.||0.154|-0.148|0.965
72616568|NCT02021318|144763897|SUPERIORITY||LSM Difference|-0.016||||0.856|TWO_SIDED|95.0|-0.188|0.157|||Mixed Models Analysis|||Weeks 96-104 - The model included treatment, visit, visit by treatment interaction, region and history of CV disease as fixed class factors and baseline Hb, baseline estimated glomerular filtration rate and baseline Hb by visit as continuous covariates.||0.157|-0.188|0.856
72616569|NCT02021318|144763899|SUPERIORITY||Hazard Ratio (HR)|1.74|||<|0.001|TWO_SIDED|95.0|1.36|2.22|||Regression, Cox|||Hazard Ratio was calculated using stratified Cox Proportional Hazards regression stratifying on CV history and Region and adjusting on Hb and eGFR at baseline as continuous covariates.||2.22|1.36|<0.001
72616570|NCT02021318|144763902|SUPERIORITY||Hazard Ratio (HR)|1.21||||0.079|TWO_SIDED|95.0|0.98|1.5|||Regression, Cox|||Hazard ratio was calculated using stratified Cox Proportional Hazards regression stratifying on CV history and Region and adjusting on Hb and eGFR at baseline as continuous covariates. Superiority was declared if the upper bound of the 95% CI is below 1.0.||1.50|0.98|0.079
72616571|NCT02021318|144763903|SUPERIORITY||Hazard Ratio (HR)|1.3||||0.3|TWO_SIDED|95.0|0.79|2.11|||Regression, Cox|||Hazard Ratio was calculated using stratified Cox Proportional Hazards regression stratifying on CV history and region and adjusting on Hb and eGFR at baseline as continuous covariates. Superiority was declared if the upper bound of the 95% CI is below 1.0.||2.11|0.79|0.300
72616572|NCT02021318|144763907|SUPERIORITY||Hazard Ratio (HR)|1.59||||0.055|TWO_SIDED|95.0|0.99|2.54|||Regression, Cox|||Hazard Ratio was calculated using stratified Cox Proportional Hazards regression stratifying on CV history and Region and adjusting on Hb and eGFR at baseline as continuous covariates. Superiority was declared if the upper bound of the 95% CI is below 1.0.||2.54|0.99|0.055
72616573|NCT02021318|144763910|SUPERIORITY||Hazard Ratio (HR)|0.71||||0.052|TWO_SIDED|95.0|0.51|1.0|||Regression, Cox|||Hazard Ratio was calculated using stratified Cox Proportional Hazards regression stratifying on CV history and region and adjusting on Hb and eGFR at baseline as continuous covariate. Superiority was declared if the upper bound of the 95% CI is below 1.0.||1.00|0.51|0.052
72616574|NCT02021318|144763920|SUPERIORITY||LSM Difference|-1.068||||0.027|TWO_SIDED|95.0|-2.012|-0.124|||Mixed Models Analysis|||Weeks 12-28 - The model included treatment, visit, visit by treatment interaction, region and history of cardiovascular disease as fixed class factors and baseline SF-36 PCS, baseline Hb, baseline estimated glomerular filtration rate as continuous covariates.||-0.124|-2.012|0.027
72616575|NCT02021318|144763920|SUPERIORITY||LSM Difference|-0.603||||0.239|TWO_SIDED|95.0|-1.606|0.401|||Mixed Models Analysis|||Weeks 36-52 - The model included treatment, visit, visit by treatment interaction, region and history of cardiovascular disease as fixed class factors and baseline SF-36 PCS, baseline Hb, baseline estimated glomerular filtration rate as continuous covariates.||0.401|-1.606|0.239
72616576|NCT02021318|144763921|SUPERIORITY||LSM Difference|-0.528||||0.517|TWO_SIDED|95.0|-2.127|1.072|||Mixed Models Analysis|||Weeks 12-28 - The model included treatment, visit, visit by treatment interaction, region and history of cardiovascular disease as fixed class factors and baseline FACT-An AnS, baseline Hb, baseline estimated glomerular filtration rate as continuous covariates.||1.072|-2.127|0.517
72616577|NCT02021318|144763921|SUPERIORITY||LSM Difference|-0.947||||0.308|TWO_SIDED|95.0|-2.771|0.877|||Mixed Models Analysis|||Weeks 36-52 - The model included treatment, visit, visit by treatment interaction, region and history of cardiovascular disease as fixed class factors and baseline FACT-An AnS, baseline Hb, baseline estimated glomerular filtration rate as continuous covariates.||0.877|-2.771|0.308
72616578|NCT02021318|144763922|SUPERIORITY||LSM Difference|-0.904||||0.57|TWO_SIDED|95.0|-4.032|2.224|||Mixed Models Analysis|||Week 12-28 - The model included treatment, visit, visit by treatment interaction, region and history of cardiovascular disease as fixed class factors and baseline FACT-An total score, baseline Hb, baseline estimated glomerular filtration rate as continuous covariates.||2.224|-4.032|0.570
72616579|NCT02021318|144763922|SUPERIORITY||LSM Difference|-1.767||||0.334|TWO_SIDED|95.0|-5.354|1.82|||Mixed Models Analysis|||Weeks 36-52 -The model included treatment, visit, visit by treatment interaction, region and history of cardiovascular disease as fixed class factors and baseline FACT-An total score, baseline Hb, baseline estimated glomerular filtration rate as continuous covariates.||1.820|-5.354|0.334
72371603|NCT00669409|144253447|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|10.3|STANDARD_ERROR_OF_MEAN|7.98|||TWO_SIDED|95.0|-5.5|26.1||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||26.1|-5.5|
72432383|NCT02696785|144377175|SUPERIORITY||LSMean Difference|-1.3|STANDARD_ERROR_OF_MEAN|0.77||0.091|TWO_SIDED|95.0|-2.8|0.2|||Mixed Models Analysis|||||0.2|-2.8|0.091
72493536|NCT03850912|144516292|OTHER||Odds Ratio (OR)|1.215||||0.014|TWO_SIDED|95.0|1.04|1.418|||Regression, Logistic|||Adjusted analysis comparing control versus intervention patients (surgical patients only)||1.418|1.040|0.014
72616580|NCT02021318|144763924|SUPERIORITY||LSM Difference|0.784||||0.497|TWO_SIDED|95.0|-1.481|3.049|||Mixed Models Analysis|||The model includes treatment, visit, visit by treatment interaction, region and history of CV disease as fixed class factors and baseline EQ-5D 5L VAS, baseline Hb, baseline eGFR as continuous covariates.||3.049|-1.481|0.497
72616581|NCT02021318|144763935|SUPERIORITY||LSM Difference|-0.05||||0.902|TWO_SIDED|95.0|-0.93|0.82|||Mixed Models Analysis|||||0.82|-0.93|0.902
72616582|NCT02021318|144763937|SUPERIORITY||Hazard Ratio (HR)|1.01||||0.96|TWO_SIDED|95.0|0.79|1.29|||Regression, Cox|||Hazard Ratio was calculated using stratified Cox Proportional Hazards regression stratifying on CV history and region and adjusting on Hb and eGFR at baseline as continuous covariates. Superiority was declared if the upper bound of the 95% CI was below 1.0.||1.29|0.79|0.960
72616583|NCT02021318|144763939|SUPERIORITY||Hazard Ratio (HR)|0.99||||0.939|TWO_SIDED|95.0|0.79|1.25|||Regression, Cox|||Hazard Ratio was calculated using stratified Cox Proportional Hazards regression stratifying on CV history and region and adjusting on Hb and eGFR at baseline as continuous covariates. Superiority was declared if the upper bound of the 95% CI was below 1.0.||1.25|0.79|0.939
72616584|NCT02021318|144763940|SUPERIORITY||Hazard Ratio (HR)|0.99||||0.948|TWO_SIDED|95.0|0.77|1.27|||Regression, Cox|||Hazard Ratio was calculated using stratified Cox Proportional Hazards regression stratifying on CV history and region and adjusting on Hb and eGFR at baseline as continuous covariates. Superiority was declared if the upper bound of the 95% CI was below 1.0.||1.27|0.77|0.948
72616585|NCT02021318|144763941|SUPERIORITY||Hazard Ratio (HR)|0.94||||0.568|TWO_SIDED|95.0|0.75|1.17|||Regression, Cox|||Hazard Ratio was calculated using stratified Cox Proportional Hazards regression stratifying on CV history and region and adjusting on Hb and eGFR at baseline as continuous covariates. Superiority was declared if the upper bound of the 95% CI was below 1.0.||1.17|0.75|0.568
72616586|NCT00441896|144764013|SUPERIORITY|||||||0.7391|||||||ANCOVA|||||||0.7391
72616587|NCT00441896|144764013|SUPERIORITY|||||||0.537|||||||ANCOVA|||||||0.5370
72616588|NCT00441896|144764013|SUPERIORITY|||||||0.908|||||||ANCOVA|||||||0.9080
72616589|NCT00441896|144764013|SUPERIORITY|||||||0.2539|||||||ANCOVA|||||||0.2539
72616590|NCT00441896|144764013|SUPERIORITY|||||||0.6657|||||||ANCOVA|||||||0.6657
72616591|NCT00441896|144764014|SUPERIORITY|||||||0.4249|||||||ANCOVA|||||||0.4249
72616592|NCT00441896|144764014|SUPERIORITY|||||||0.4177|||||||ANCOVA|||||||0.4177
72616593|NCT00441896|144764014|SUPERIORITY|||||||0.3033|||||||ANCOVA|||||||0.3033
72616594|NCT00441896|144764014|SUPERIORITY|||||||0.3014|||||||ANCOVA|||||||0.3014
72616595|NCT00441896|144764014|SUPERIORITY|||||||0.1839|||||||ANCOVA|||||||0.1839
72616596|NCT01350973|144764022|SUPERIORITY_OR_OTHER||LS Mean Difference|0.37||||0.876|TWO_SIDED|95.0|-4.2491|4.983||An ANCOVA model was employed, using the baseline triglyceride level as covariate and the treatment group as an independent variable.|ANCOVA|||||4.9830|-4.2491|0.8760
72493537|NCT03850912|144516293|OTHER||Odds Ratio (OR)|1.002||||0.978|TWO_SIDED|95.0|0.881|1.139|||Regression, Logistic|||Adjusted analysis comparing control versus intervention patients (medical oncology and surgical patients combined)||1.139|0.881|0.978
72616597|NCT01350973|144764022|SUPERIORITY_OR_OTHER||LS Mean Difference|-11.35|||<|0.0001|TWO_SIDED|95.0|-15.9442|-6.7637||An ANCOVA model was employed, using the baseline triglyceride level as covariate and the treatment group as an independent variable.|ANCOVA|||||-6.7637|-15.9442|< 0.0001
72616598|NCT02507284|144764033|NON_INFERIORITY|Results for the secondary safety endpoint, adverse events (AEs) in study subjects, was performed using a test for non-inferiority with a threshold of 0.50. The null hypothesis is that the treatment minus placebo proportion difference is greater than (or equal to) the margin of 0.50 and the alternative hypothesis is that the difference is less than 0.50.|Risk Ratio (RR)|0.025||||0.5|ONE_SIDED|97.5|||||t-test, 1 sided|||||||0.50
72616599|NCT01033071|144764042|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.3|||<|0.001||95.0|-7.6|-3.1||"Overall Type 1 error rate of 0.05 controlled using 'Closed Testing' principle (hypothesis of all treatment groups equal first tested at 0.05 significance level; upon rejection of this hypothesis, pairwise comparison was tested at the 0.05 level."|ANCOVA|||Analysis of covariance (ANCOVA) model with treatment group as a fixed effect and baseline value as a covariate.||-3.1|-7.6|<0.001
72616600|NCT01033071|144764042|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.9|||<|0.001|TWO_SIDED|95.0|-9.2|-4.6||"Overall Type 1 error rate of 0.05 controlled using 'Closed Testing' principle (hypothesis of all treatment groups equal first tested at 0.05 significance level; upon rejection of this hypothesis, pairwise comparison was tested at the 0.05 level."|ANCOVA|||ANCOVA model with treatment group as a fixed effect and baseline value as a covariate.||-4.6|-9.2|<0.001
72616601|NCT01033071|144764045|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.0|||<|0.001|TWO_SIDED|95.0|-9.4|-4.7||Tested at the 0.05 significance level.|ANCOVA|||ANCOVA model with treatment group as a fixed effect and baseline value as a covariate.||-4.7|-9.4|<0.001
72616602|NCT01033071|144764045|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.0|||<|0.001|TWO_SIDED|95.0|-11.5|-6.6||Tested at the 0.05 significance level.|ANCOVA|||ANCOVA model with treatment group as a fixed effect and baseline value as a covariate.||-6.6|-11.5|<0.001
72616603|NCT01033071|144764047|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.4|||<|0.001|TWO_SIDED|95.0|-8.5|-4.3||Tested at the 0.05 significance level.|ANCOVA|||ANCOVA model with treatment group as a fixed effect and baseline value as a covariate.||-4.3|-8.5|<0.001
72616604|NCT01033071|144764047|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.8|||<|0.001|TWO_SIDED|95.0|-11.0|-6.7||Tested at the 0.05 significance level.|ANCOVA|||ANCOVA model with treatment group as a fixed effect and baseline value as a covariate.||-6.7|-11.0|<0.001
72616605|NCT00004859|144764063|SUPERIORITY_OR_OTHER|||||||0.99|TWO_SIDED|95.0|||||Log Rank|||||||0.99
72616606|NCT01258855|144764091|OTHER|||||||0.002|||||||Log Rank|||||||0.002
72616607|NCT01258855|144764092|OTHER|||||||0.43|||||||Log Rank|||||||0.43
72616608|NCT01258855|144764095|OTHER|||||||0.003|||||||Log Rank|||||||0.003
72616609|NCT01258855|144764096|OTHER|||||||0.02|||||||Log Rank|||||||0.02
72616610|NCT01567085|144764098|OTHER|Exact binomial test|||||<|0.001||||||The p-value was calculated from an exact binomial test, where the null hypothesis was that the true failure rate = 40%.|Exact binomial test|Exact 95% confidence interval (3.6, 17.2)||Analysis of post-transplantation treatment failure rate||||< 0.001
72616611|NCT03928704|144764114|SUPERIORITY||Odds Ratio (OR)|3.51|||<|0.001|TWO_SIDED|95.0|2.0|6.16|||Regression, Logistic|||||6.16|2.00|<0.001
72616612|NCT03928704|144764115|SUPERIORITY||Odds Ratio (OR)|3.08|||<|0.001|TWO_SIDED|95.0|1.71|5.54|||Regression, Logistic|||||5.54|1.71|<0.001
72616613|NCT03928704|144764116|SUPERIORITY||LS Mean difference|-1.51|||<|0.001||95.0|-2.04|-0.98|||ANCOVA|||||-0.98|-2.04|<0.001
72493538|NCT03850912|144516293|OTHER||Odds Ratio (OR)|0.854||||0.126|TWO_SIDED|95.0|0.697|1.046|||Regression, Logistic|||Adjusted analysis comparing control versus intervention patients (medical oncology patients only)||1.046|0.697|0.126
72616614|NCT03928704|144764116|SUPERIORITY||LS Mean difference|-0.91||||0.22|TWO_SIDED|95.0|-2.42|0.61|||ANCOVA|||||0.61|-2.42|0.220
72616615|NCT03928704|144764117|SUPERIORITY||Odds Ratio (OR)|3.69|||<|0.001|TWO_SIDED|95.0|2.17|6.26|||Regression, Logistic|||||6.26|2.17|<0.001
72616616|NCT03928704|144764118|SUPERIORITY||Odds Ratio (OR)|4.52|||<|0.001|TWO_SIDED|95.0|2.06|9.93|||Regression, Logistic|||||9.93|2.06|<0.001
72616617|NCT03928704|144764119|SUPERIORITY||Odds Ratio (OR)|5.43|||<|0.001|TWO_SIDED|95.0|2.41|12.23|||Regression, Logistic|||||12.23|2.41|<0.001
72616618|NCT03928704|144764120|SUPERIORITY||Odds Ratio (OR)|3.31|||<|0.001|TWO_SIDED|95.0|1.87|5.84|||Regression, Logistic|||||5.84|1.87|<0.001
72616619|NCT03928704|144764121|SUPERIORITY||LS Mean difference|-1.48|||<|0.001||95.0|-1.99|-0.97|||ANCOVA|||||-0.97|-1.99|<0.001
72616620|NCT03928704|144764121|SUPERIORITY||LS Mean difference|-1.25||||0.019|TWO_SIDED|95.0|-2.26|-0.24|||ANCOVA|||||-0.24|-2.26|0.019
72616621|NCT03928704|144764122|SUPERIORITY||LS Mean difference|-1.8|||<|0.001||95.0|-2.42|-1.18|||ANCOVA|||||-1.18|-2.42|<0.001
72616622|NCT03928704|144764122|SUPERIORITY||LS Mean difference|-1.09||||0.199|TWO_SIDED|95.0|-2.83|0.65|||ANCOVA|||||0.65|-2.83|0.199
72616623|NCT03928704|144764123|SUPERIORITY||LS Mean difference|-2.63|||<|0.001||95.0|-3.66|-1.61|||ANCOVA|||||-1.61|-3.66|<0.001
72616624|NCT03928704|144764123|SUPERIORITY||LS Mean difference|-1.84||||0.17|TWO_SIDED|95.0|-4.56|0.89|||ANCOVA|||||0.89|-4.56|0.170
72616625|NCT03928704|144764124|SUPERIORITY||LS Mean difference|3.96|||<|0.001|TWO_SIDED|95.0|2.08|5.83|||ANCOVA|||||5.83|2.08|<0.001
72616626|NCT03928704|144764124|SUPERIORITY||LS Mean difference|7.27||||0.035|TWO_SIDED|95.0|0.6|13.95|||ANCOVA|||||13.95|0.60|0.035
72616627|NCT03928704|144764125|SUPERIORITY||LS Mean difference|-0.33|||<|0.001|TWO_SIDED|95.0|-0.52|-0.14|||ANCOVA|||||-0.14|-0.52|<0.001
72616628|NCT03928704|144764125|SUPERIORITY||LS Mean difference|-0.5||||0.086|TWO_SIDED|95.0|-1.07|0.07|||ANCOVA|||||0.07|-1.07|0.086
72616629|NCT03928704|144764126|SUPERIORITY||LS Mean difference|-1.06|||=|0.013|TWO_SIDED|95.0|-1.88|-0.23|||ANCOVA|||||-0.23|-1.88|=0.013
72616630|NCT03928704|144764127|SUPERIORITY||Odds Ratio (OR)|3.49|||<|0.001|TWO_SIDED|95.0|1.84|6.62|||Regression, Logistic|||||6.62|1.84|<0.001
72616631|NCT03083379|144764134|EQUIVALENCE|Equivalency is defined as no statistically significant difference in dorsal region redistribution of ventilation following breath cycle 1, 2, and 3 lung expansion therapy sequences.||||||0.9|||||||Mann-Whitney U test|||||||.90
72616632|NCT03403517|144764146|SUPERIORITY||Risk Ratio (RR)|0.859||||0.213|TWO_SIDED|95.0|0.682|1.082|||Fisher Exact|||||1.082|0.682|0.213
72616633|NCT03403517|144764150|SUPERIORITY||Risk Ratio (RR)|0.977|||>|0.999|TWO_SIDED|95.0|0.557|1.715|||Fisher Exact|||||1.715|0.557|>0.999
72616634|NCT03403517|144764151|SUPERIORITY|||||||0.16|||||||Fisher Exact|||||||0.160
72616635|NCT03695094|144764167|OTHER||Geometric mean ratio|0.725|||||TWO_SIDED|90.0|0.586|0.896|||ANOVA|||The analysis of variance model (ANOVA) included the fixed effects of treatment group. The natural logs were taken of the dependent variables and were back-transformed after the analysis. The geometric mean ratio and the respective 90% confidence interval (CI) was derived for the Inducers group vs the Neutral-control group from the ANOVA model using least-squares means difference.||0.896|0.586|
72616636|NCT03695094|144764169|OTHER||Geometric mean ratio|0.636|||||TWO_SIDED|90.0|0.504|0.801|||ANOVA|||The analysis of variance model (ANOVA) included the fixed effects of treatment group. The natural logs were taken of the dependent variables and were back-transformed after the analysis. The geometric mean ratio and the respective 90% confidence interval (CI) was derived for the Inducers group vs the Neutral-control group from the ANOVA model using least-squares means difference.||0.801|0.504|
72616637|NCT01779362|144764216|SUPERIORITY||||||>|0.05||||||All analyses were conducted with values on a log scale and re-exponentiated for presentation.|Regression, Linear|Measures of ß-cell response were modeled simultaneously with insulin sensitivity (M/I) using 2-df seemingly unrelated regression models.||Seemingly unrelated regression was used to compare treatment arms on the combination of insulin sensitivity (M/I as calculated from the hyperglycemic clamp) and insulin secretion (steady-state C-peptide and ACPRmax as co-primary; ACPRg as major secondary,). See statistical analysis plan for further details and R code.||||>0.05
72616638|NCT01779362|144764217|SUPERIORITY||||||>|0.05|||||||Regression, Linear|||||||>0.05
72616639|NCT01779362|144764218|SUPERIORITY||||||>|0.05|||||||Regression, Linear|||||||>0.05
72616640|NCT01779362|144764219|SUPERIORITY||||||<|0.001||||||For all 3 secondary outcomes at M12, p\<0.001, with the Liraglutide+Metformin group different from the 3 others (all p\<0.001).|ANOVA|||Analyses were completed on a log scale and re-exponentiated for display.||||<0.001
72616641|NCT00422461|144764222|SUPERIORITY||Least square (LS) mean difference|-2.8|STANDARD_ERROR_OF_MEAN|1.6||0.0822|TWO_SIDED|95.0|-5.97|0.36|||Nonlinear dose response regression model|||||0.36|-5.97|0.0822
72493539|NCT03850912|144516293|OTHER||Odds Ratio (OR)|1.102||||0.254|TWO_SIDED|95.0|0.933|1.302|||Regression, Logistic|||Adjusted analysis comparing control versus intervention patients (surgical patients only)||1.302|0.933|0.254
72493540|NCT03850912|144516294|OTHER||Odds Ratio (OR)|1.068||||0.209|TWO_SIDED|95.0|0.964|1.183|||Regression, Logistic|||Adjusted analysis comparing control versus intervention patients (medical oncology and surgical patients combined)||1.183|0.964|0.209
72493541|NCT03850912|144516294|OTHER||Odds Ratio (OR)|0.992||||0.924|TWO_SIDED|95.0|0.85|1.159|||Regression, Logistic|||Adjusted analysis comparing control versus intervention patients (medical oncology patients only)||1.159|0.850|0.924
72493542|NCT03850912|144516294|OTHER||Odds Ratio (OR)|1.122||||0.099|TWO_SIDED|95.0|0.979|1.286|||Regression, Logistic|||Adjusted analysis comparing control versus intervention patients (surgical patients only)||1.286|0.979|0.099
72493543|NCT03850912|144516295|SUPERIORITY||Difference|-1.328||||0.04|TWO_SIDED|95.0|-2.593|-0.062|||Regression, Linear|||Multivariable regression analyses (medical oncology cohort only)||-0.062|-2.593|0.04
72493544|NCT03850912|144516295|OTHER||Difference|-1.958||||0.004|TWO_SIDED|95.0|-3.269|-0.646|||Regression, Logistic|||Multivariable regression analyses (surgical cohort only)||-0.646|-3.269|0.004
72493545|NCT03850912|144516296|SUPERIORITY||Difference|-0.925||||0.09|TWO_SIDED|95.0|-1.985|0.136|||Regression, Linear|||Multivariable regression analyses (medical oncology cohort only)||0.136|-1.985|0.09
72493546|NCT03850912|144516296|SUPERIORITY||Difference|-1.516||||0.002|TWO_SIDED|95.0|-2.474|-0.557|||Regression, Linear|||Multivariable regression analyses (surgical cohort only)||-0.557|-2.474|0.002
72493547|NCT03850912|144516297|SUPERIORITY||Difference|-1.767||||0.17|TWO_SIDED|95.0|-2.532|0.433|||Regression, Linear|||Multivariable regression analyses (medical oncology cohort only)||0.433|-2.532|0.17
72493548|NCT03850912|144516297|SUPERIORITY||Difference|-2.198|||<|0.0001|TWO_SIDED|95.0|-3.259|-1.137|||Regression, Linear|||Multivariable regression analyses (surgical cohort only)||-1.137|-3.259|<0.0001
72493549|NCT03850912|144516298|SUPERIORITY||Difference|-0.8084||||0.2|TWO_SIDED|95.0|-2.048|0.431|||Regression, Linear|||Multivariable regression analyses (medical oncology cohort only)||0.431|-2.048|0.2
72493550|NCT03850912|144516298|SUPERIORITY||Difference|-0.652||||0.27|TWO_SIDED|95.0|-1.8|0.496|||Regression, Linear|||Multivariable regression analyses (surgical cohort only)||0.496|-1.800|0.27
72493551|NCT03850912|144516299|SUPERIORITY||Difference|-0.617||||0.23|TWO_SIDED|95.0|-1.62|0.386|||Regression, Linear|||Multivariable regression analyses (medical oncology cohort only)||0.386|-1.620|0.23
72493552|NCT03850912|144516299|SUPERIORITY||Difference|0.434||||0.39|TWO_SIDED|95.0|-0.563|1.431|||Regression, Linear|||Multivariable regression analyses (surgical cohort only)||1.431|-0.563|0.39
72493553|NCT03850912|144516300|SUPERIORITY||Difference|-0.7||||0.22|TWO_SIDED|95.0|-1.829|0.429|||Regression, Linear|||Multivariable regression analyses (medical oncology cohort only)||0.429|-1.829|0.22
72493554|NCT03850912|144516300|SUPERIORITY||Difference|-0.58||||0.28|TWO_SIDED|95.0|-1.632|0.472|||Regression, Linear|||Multivariable regression analyses (surgical cohort only)||0.472|-1.632|0.28
72493555|NCT03850912|144516301|SUPERIORITY||Odds Ratio (OR)|0.842|||<|0.001|TWO_SIDED|95.0|0.776|0.913|||Regression, Logistic|||Adjusted analysis comparing intervention responders versus non-responders (chemo and surgical patients combined)||0.913|0.776|<0.001
72493556|NCT03850912|144516301|SUPERIORITY||Odds Ratio (OR)|0.78|||<|0.001|TWO_SIDED|95.0|0.688|0.885|||Regression, Logistic|||Adjusted analysis comparing intervention responders versus non-responders (medical oncology patients only)||0.885|0.688|<0.001
72493557|NCT03850912|144516301|SUPERIORITY||Odds Ratio (OR)|0.889||||0.032|TWO_SIDED|95.0|0.799|0.99|||Regression, Logistic|||Adjusted analysis comparing intervention responders versus non-responders (surgical patients only)||0.990|0.799|0.032
72493558|NCT03850912|144516302|SUPERIORITY||Odds Ratio (OR)|0.893|||<|0.001|TWO_SIDED|95.0|0.839|0.949|||Regression, Logistic|||Adjusted analysis comparing intervention responders versus non-responders (medical oncology and surgical patients combined)||0.949|0.839|<0.001
72493559|NCT03850912|144516302|SUPERIORITY||Odds Ratio (OR)|0.872||||0.003|TWO_SIDED|95.0|0.796|0.954|||Regression, Logistic|||Adjusted analysis comparing intervention responders versus non-responders (medical oncology patients only)||0.954|0.796|0.003
72493560|NCT03850912|144516302|SUPERIORITY||Odds Ratio (OR)|0.909||||0.027|TWO_SIDED|95.0|0.835|0.989|||Regression, Logistic|||Adjusted analysis comparing intervention responders versus non-responders (surgical patients only)||0.989|0.835|0.027
72493561|NCT03850912|144516303|SUPERIORITY||Odds Ratio (OR)|0.636|||<|0.001|TWO_SIDED|95.0|0.593|0.682|||Regression, Logistic|||Adjusted analysis comparing intervention responders versus non-responders (medical oncology and surgical patients combined)||0.682|0.593|<0.001
72493562|NCT03850912|144516303|SUPERIORITY||Odds Ratio (OR)|0.611|||<|0.001|TWO_SIDED|95.0|0.55|0.679|||Regression, Logistic|||Adjusted analysis comparing intervention responders versus non-responders (medical oncology patients only)||0.679|0.550|<0.001
72493563|NCT03850912|144516303|SUPERIORITY||Odds Ratio (OR)|0.655|||<|0.001|TWO_SIDED|95.0|0.597|0.719|||Regression, Logistic|||Adjusted analysis comparing intervention responders versus non-responders (surgical patients only)||0.719|0.597|<0.001
72493564|NCT03850912|144516304|SUPERIORITY||Odds Ratio (OR)|0.769|||<|0.001|TWO_SIDED|95.0|0.729|0.811|||Regression, Logistic|||Adjusted analysis comparing intervention responders versus non-responders (medical oncology and surgical patients combined)||0.811|0.729|<0.001
72616642|NCT00422461|144764222|SUPERIORITY||LS mean difference|-4.66|STANDARD_ERROR_OF_MEAN|1.92||0.017|TWO_SIDED|95.0|-8.47|-0.85|||Nonlinear dose response regression model|||||-0.85|-8.47|0.0170
72616643|NCT00422461|144764222|SUPERIORITY||LS mean difference|-6.97|STANDARD_ERROR_OF_MEAN|2.26||0.0026|TWO_SIDED|95.0|-11.45|-2.48|||Nonlinear dose response regression model|||||-2.48|-11.45|0.0026
72616644|NCT00422461|144764223|SUPERIORITY||LS mean difference|-2.7|STANDARD_ERROR_OF_MEAN|1.2||0.0264|TWO_SIDED|95.0|-5.09|-0.32|||Nonlinear dose response regression model|||||-0.32|-5.09|0.0264
72616645|NCT00422461|144764223|SUPERIORITY||LS mean difference|-4.56|STANDARD_ERROR_OF_MEAN|1.41||0.0016|TWO_SIDED|95.0|-7.35|-1.77|||Nonlinear dose response regression model|||||-1.77|-7.35|0.0016
72616646|NCT00422461|144764223|SUPERIORITY||LS mean difference|-6.96|STANDARD_ERROR_OF_MEAN|1.55|<|0.0001|TWO_SIDED|95.0|-10.03|-3.89|||Nonlinear dose response regression model|||||-3.89|-10.03|<0.0001
72616647|NCT00422461|144764224|SUPERIORITY||LS mean difference|0.13|STANDARD_ERROR_OF_MEAN|1.98||0.9479|TWO_SIDED|95.0|-3.79|4.05|||ANCOVA|||For SBP||4.05|-3.79|0.9479
72616648|NCT00422461|144764224|SUPERIORITY||LS mean difference|-4.75|STANDARD_ERROR_OF_MEAN|2.03||0.0215|TWO_SIDED|95.0|-8.78|-0.72|||ANCOVA|||For SBP||-0.72|-8.78|0.0215
72616649|NCT00422461|144764224|SUPERIORITY||LS mean difference|-3.43|STANDARD_ERROR_OF_MEAN|2.0||0.0886|TWO_SIDED|95.0|-7.39|0.53|||ANCOVA|||For SBP||0.53|-7.39|0.0886
72616650|NCT00422461|144764224|SUPERIORITY||LS mean difference|-1.45|STANDARD_ERROR_OF_MEAN|1.44||0.3173|TWO_SIDED|95.0|-4.3|1.41|||ANCOVA|||For DBP||1.41|-4.30|0.3173
72616651|NCT00422461|144764224|SUPERIORITY||LS mean difference|-3.81|STANDARD_ERROR_OF_MEAN|1.42||0.0087|TWO_SIDED|95.0|-6.64|-0.99|||ANCOVA|||For DBP||-0.99|-6.64|0.0087
72616652|NCT00422461|144764224|SUPERIORITY||LS mean difference|-3.95|STANDARD_ERROR_OF_MEAN|1.41||0.0062|TWO_SIDED|95.0|-6.76|-1.15|||ANCOVA|||For DBP||-1.15|-6.76|0.0062
72616653|NCT00422461|144764226|SUPERIORITY||LS mean difference|-0.6|STANDARD_ERROR_OF_MEAN|2.48||0.8091|TWO_SIDED|95.0|-5.51|4.31|||ANCOVA|||For cuff SBP||4.31|-5.51|0.8091
72616654|NCT00422461|144764226|SUPERIORITY||LS mean difference|-0.37|STANDARD_ERROR_OF_MEAN|2.44||0.8809|TWO_SIDED|95.0|-5.21|4.48|||ANCOVA|||For cuff SBP||4.48|-5.21|0.8809
72616655|NCT00422461|144764226|SUPERIORITY||LS mean difference|-5.16|STANDARD_ERROR_OF_MEAN|2.46||0.0382|TWO_SIDED|95.0|-10.04|-0.29|||ANCOVA|||For cuff SBP||-0.29|-10.04|0.0382
72616656|NCT00422461|144764226|SUPERIORITY||LS mean difference|-3.03|STANDARD_ERROR_OF_MEAN|1.67||0.0731|TWO_SIDED|95.0|-6.35|0.29|||ANCOVA|||For cuff DBP||0.29|-6.35|0.0731
72616657|NCT00422461|144764226|SUPERIORITY||LS mean difference|-4.49|STANDARD_ERROR_OF_MEAN|1.65||0.0077|TWO_SIDED|95.0|-7.77|-1.22|||ANCOVA|||For cuff DBP||-1.22|-7.77|0.0077
72616658|NCT00422461|144764226|SUPERIORITY||LS mean difference|-4.29|STANDARD_ERROR_OF_MEAN|1.66||0.0111|TWO_SIDED|95.0|-7.58|-1.0|||ANCOVA|||For cuff DBP||-1.00|-7.58|0.0111
72371604|NCT00669409|144253447|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-11.3|STANDARD_ERROR_OF_MEAN|7.98|||TWO_SIDED|95.0|-27.0|4.5||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||4.5|-27.0|
72616659|NCT00422461|144764228|SUPERIORITY||LS mean difference|-1.94|STANDARD_ERROR_OF_MEAN|1.7||0.2567|TWO_SIDED|95.0|-5.32|1.44|||ANCOVA|||||1.44|-5.32|0.2567
72616660|NCT00422461|144764228|SUPERIORITY||LS mean difference|-2.94|STANDARD_ERROR_OF_MEAN|1.69||0.086|TWO_SIDED|95.0|-6.29|0.42|||ANCOVA|||||0.42|-6.29|0.0860
72616661|NCT00422461|144764228|SUPERIORITY||LS mean difference|-4.46|STANDARD_ERROR_OF_MEAN|1.71||0.0103|TWO_SIDED|95.0|-7.85|-1.08|||ANCOVA|||||-1.08|-7.85|0.0103
72616662|NCT01795937|144764239|NON_INFERIORITY_OR_EQUIVALENCE|Investigation of relative bioavailability (no formal testing)|Geometric Mean Ratio|198.55|STANDARD_DEVIATION|14.2|||TWO_SIDED|90.0|182.43|216.09|||ANOVA|ANOVA with fixed effect for treatment and random effect for subject.|The standard deviation is actually the geometric coefficient of variation.|Relative bioavailability comparison faldaprevir+itraconazole : faldaprevir||216.09|182.43|
72616663|NCT01795937|144764240|NON_INFERIORITY_OR_EQUIVALENCE|Investigation of relative bioavailability (no formal testing).|Geometric Mean Ratio|180.63|STANDARD_DEVIATION|14.5|||TWO_SIDED|90.0|165.68|196.93|||ANOVA|ANOVA with fixed effect for treatment and random effect for subject.|The standard deviation is actually the geometric coefficient of variation.|Relative bioavailability comparison faldaprevir+itraconazole : faldaprevir.||196.93|165.68|
72616664|NCT01795937|144764241|NON_INFERIORITY_OR_EQUIVALENCE|Investigation of relative bioavailability (no formal testing).|Geometric Mean Ratio|946.45|STANDARD_DEVIATION|27.3|||TWO_SIDED|90.0|797.61|1123.07|||ANOVA|ANOVA with fixed effect for treatment and random effect for subject.|The standard deviation is actually the geometric coefficient of variation.|Relative bioavailability comparison atorvastatin+faldaprevir : atorvastatin.||1123.07|797.61|
72616665|NCT01795937|144764242|NON_INFERIORITY_OR_EQUIVALENCE|Investigation of relative bioavailability (no formal testing).|Geometric Mean Ratio|3372.72|STANDARD_DEVIATION|20.5|||TWO_SIDED|90.0|2961.95|3840.47|||ANOVA|ANOVA with fixed effect for treatment and random effect for subject.|The standard deviation is actually the geometric coefficient of variation.|Relative bioavailability comparison atorvastatin+faldaprevir : atorvastatin.||3840.47|2961.95|
72616666|NCT01795937|144764245|NON_INFERIORITY_OR_EQUIVALENCE|Investigation of relative bioavailability (no formal testing).|Geometric Mean Ratio|1358.91|STANDARD_DEVIATION|16.4|||TWO_SIDED|90.0|1224.32|1508.29|||ANOVA|ANOVA with fixed effect for treatment and random effect for subject.|The standard deviation is actually the geometric coefficient of variation.|Relative bioavailability comparison atorvastatin+faldaprevir : atorvastatin.||1508.29|1224.32|
72616667|NCT01795937|144764246|NON_INFERIORITY_OR_EQUIVALENCE|Investigation of relative bioavailability (no formal testing).|Geometric Mean Ratio|1466.35|STANDARD_DEVIATION|23.3|||TWO_SIDED|90.0|1277.62|1682.95|||ANOVA|ANOVA with fixed effect for treatment and random effect for subject.|The standard deviation is actually the geometric coefficient of variation.|Relative bioavailability comparison rosuvastatin+faldaprevir : rosuvastatin.||1682.95|1277.62|
72616668|NCT01795937|144764247|NON_INFERIORITY_OR_EQUIVALENCE|Investigation of relative bioavailability (no formal testing).|Geometric Mean Ratio|3288.7|STANDARD_DEVIATION|28.5|||TWO_SIDED|90.0|2782.04|3887.63|||ANOVA|ANOVA with fixed effect for treatment and random effect for subject.|The standard deviation is actually the geometric coefficient of variation.|Relative bioavailability comparison rosuvastatin+faldaprevir : rosuvastatin.||3887.63|2782.04|
72616669|NCT01795937|144764248|NON_INFERIORITY_OR_EQUIVALENCE|Investigation of relative bioavailability (no formal testing).|Geometric Mean Ratio|1678.23|STANDARD_DEVIATION|22.6|||TWO_SIDED|90.0|1468.52|1917.89|||ANOVA|ANOVA with fixed effect for treatment and random effect for subject.|The standard deviation is actually the geometric coefficient of variation.|Relative bioavailability comparison rosuvastatin+faldaprevir : rosuvastatin.||1917.89|1468.52|
72616670|NCT03593629|144764251|NON_INFERIORITY|Non-inferiority margin was defined as -10%|Risk Difference (RD)|2.37|||||ONE_SIDED|95.0|-5.05||||||||||-5.05|
72616671|NCT03593629|144764252|NON_INFERIORITY|non-inferiority margin is defined as -10%|Risk Difference (RD)|-2.6|||||ONE_SIDED|95.0|-8.88||||||||||-8.88|
72616672|NCT03593629|144764253|NON_INFERIORITY|non-inferiority margin is defined as -10%|Risk Difference (RD)|-1.15|||||ONE_SIDED|95.0|-6.89||||||||||-6.89|
72616673|NCT00983957|144764284|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|1.105|||||TWO_SIDED|90.0|1.023|1.195|||||Point estimates and 90% Confidence Interval (CIs) for treatment differences on the log scale were exponentiated to obtain estimates for ratios of geometric means on the original scale.|Mixed effect models were fitted to log-transformed data with treatment as a fixed effect, and measurements within each participant as repeated measurements.||1.195|1.023|
72616674|NCT00983957|144764285|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|1.071|||||TWO_SIDED|90.0|0.988|1.16|||||Point estimates and 90% CIs for treatment differences on the log scale were exponentiated to obtain estimates for ratios of geometric means on the original scale.|Mixed effect models were fitted to log-transformed data with treatment as a fixed effect, and measurements within each participant as repeated measurements.||1.160|0.988|
72616675|NCT00983957|144764286|SUPERIORITY_OR_OTHER||Adjusted geometric mean|1.009|||||TWO_SIDED|90.0|0.951|1.07|||||Point estimates and 90% CIs for treatment differences on the log scale were exponentiated to obtain estimates for ratios of geometric means on the original scale.|Mixed effect models were fitted to log-transformed data with treatment as a fixed effect, and measurements within each participant as repeated measurements.||1.070|0.951|
72616676|NCT00983957|144764287|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|1.121|||||TWO_SIDED|90.0|1.018|1.234|||||Point estimates and 90% CIs for treatment differences on the log scale were exponentiated to obtain estimates for ratios of geometric means on the original scale.|Mixed effect models were fitted to log-transformed data with treatment as a fixed effect, and measurements within each participant as repeated measurements.||1.234|1.018|
72616677|NCT00983957|144764290|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|1.059|||||TWO_SIDED|90.0|0.988|1.135|||||Point estimates and 90% CIs for treatment differences on the log scale were exponentiated to obtain estimates for ratios of geometric means on the original scale.|Mixed effect models were fitted to log-transformed data with treatment as a fixed effect, and measurements within each participant as repeated measurements.||1.135|0.988|
72616678|NCT00983957|144764295|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|1.115|||||TWO_SIDED|90.0|1.063|1.171|||||Point estimates and 90% CIs for treatment differences on the log scale were exponentiated to obtain estimates for ratios of geometric means on the original scale.|Mixed effect models were fitted to log-transformed data with treatment as a fixed effect, and measurements within each participant as repeated measurements.||1.171|1.063|
72616679|NCT03676725|144764387|SUPERIORITY||Odds Ratio (OR)|5.17||||0.017|ONE_SIDED||||||Fisher Exact|||Women with PMS vs. without PMS.||||0.017
72616680|NCT03676725|144764387|SUPERIORITY||Odds Ratio (OR)|16.0||||0.001|TWO_SIDED||||||Fisher Exact|||Women with PMS and with ADHD vs. other women||||0.001
72616681|NCT03676725|144764387|SUPERIORITY||Odds Ratio (OR)|0.86||||0.8|TWO_SIDED||||||Fisher Exact|||ADHD vs. no ADHD||||0.8
72616682|NCT01579305|144764415|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin is pre-defined as 15% i.e., if the difference in responder rates is significantly greater than -15% (i.e., the lower confidence limit is greater than -15%), statistical non-inferiority of VOLBELLA® to Restylane-L® is established.|Difference in responder rates|4.9|||||ONE_SIDED|97.5|-6.7||||||Difference in responder rates is calculated as the responder rate at Month 3 for VOLBELLA® minus the responder rate at Month 3 for Restylane-L®.|The null hypothesis is that VOLBELLA® is inferior to Restylane-L® in terms of responder rate at Month 3, and the alternative hypothesis is that VOLBELLA® is inferior to Restylane-L® in terms of responder rate at Month 3 with 15% pre-defined non-inferiority margin. To test the null hypothesis, a difference in responder rates of these products (VOLBELLA® - Restylane-L®) at Month 3 and a 1-sided 97.5% Wald confidence interval for the difference is calculated.|||-6.7|
72616683|NCT03446573|144764434|NON_INFERIORITY|Non-inferiority of switching to DTG + 3TC compared to continuation of TBR (as per FDA snapshot algorithm) was to be concluded if the upper bound of a two-sided 95% confidence interval (CI) for the difference in virologic failure rates between the two treatment arms was smaller than 4%.|Adjusted difference in proportion (ADP)|-0.3|||||TWO_SIDED|95.0|-1.2|0.7|||||ADP was based on Cochran-Mantel Haenszel stratified analysis adjusting for Baseline stratification factor:Baseline third agent (protease inhibitor \[PI\], non-nucleoside reverse transcriptase inhibitor \[NNRTI\], and integrase inhibitor \[INI\]).|||0.7|-1.2|
72616684|NCT03446573|144764435|NON_INFERIORITY|Non-inferiority of switching to DTG + 3TC compared to continuation of TBR (as per FDA snapshot algorithm) was to be concluded when the lower bound of a 2-sided 95% confidence interval for the difference in success rates between the two treatment arms was greater than -8%.|Adjusted difference in proportion|0.2|||||TWO_SIDED|95.0|-3.4|3.9|||||ADP was based on Cochran-Mantel Haenszel stratified analysis adjusting for Baseline stratification factor: Baseline third agent (PI, NNRTI, and INSTI).|||3.9|-3.4|
72616685|NCT03446573|144764461|OTHER||Treatment ratio|1.057||||0.257|TWO_SIDED|95.0|0.96|1.164|||Mixed Model Repeated Measures||Treatment ratio (DTG+3TC/ TAF based regimen) and 95% CI for UA/C at Week 24 has been presented.|||1.164|0.960|0.257
72616686|NCT03446573|144764461|OTHER||Treatment ratio|1.062||||0.35|TWO_SIDED|95.0|0.936|1.205|||Mixed Model Repeated Measures||Treatment ratio (DTG+3TC/ TAF based regimen) and 95% CI for UA/C at Week 48 has been presented.|||1.205|0.936|0.350
72371605|NCT00669409|144253447|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|2.5|STANDARD_ERROR_OF_MEAN|7.99|||TWO_SIDED|95.0|-13.3|18.3||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||18.3|-13.3|
72371606|NCT00669409|144253447|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-3.7|STANDARD_ERROR_OF_MEAN|7.88|||TWO_SIDED|95.0|-19.2|11.9||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||11.9|-19.2|
72616687|NCT03446573|144764461|OTHER||Treatment ratio|0.979||||0.473|TWO_SIDED|95.0|0.924|1.037|||Mixed Model Repeated Measures||Treatment ratio (DTG+3TC/ TAF based regimen) and 95% CI for UP/C at Week 24 has been presented.|||1.037|0.924|0.473
72616688|NCT03446573|144764461|OTHER||Treatment ratio|0.956||||0.212|TWO_SIDED|95.0|0.891|1.026|||Mixed Model Repeated Measures||Treatment ratio (DTG+3TC/ TAF based regimen) and 95% CI for UP/C at Week 48 has been presented.|||1.026|0.891|0.212
72616689|NCT03446573|144764463|OTHER||Treatment ratio|0.977||||0.7|TWO_SIDED|95.0|0.866|1.102|||Mixed Model Repeated Measures||Treatment ratio (DTG+3TC/ TAF based regimen) and 95% CI for UA/C at Week 96 has been presented.|||1.102|0.866|0.700
72616690|NCT03446573|144764463|OTHER||Treatment ratio|0.971||||0.7|TWO_SIDED|95.0|0.835|1.129|||Mixed Model Repeated Measures||Treatment ratio (DTG+3TC/ TAF based regimen) and 95% CI for UA/C at Week 144 has been presented.|||1.129|0.835|0.700
72616691|NCT03446573|144764463|OTHER||Treatment ratio|0.969||||0.356|TWO_SIDED|95.0|0.907|1.036|||Mixed Model Repeated Measures||Treatment ratio (DTG+3TC/ TAF based regimen) and 95% CI for UP/C at Week 96 has been presented.|||1.036|0.907|0.356
72616692|NCT03446573|144764463|OTHER||Treatment ratio|0.991||||0.814|TWO_SIDED|95.0|0.916|1.071|||Mixed Model Repeated Measures||Treatment ratio (DTG+3TC/ TAF based regimen) and 95% CI for UP/C at Week 144 has been presented.|||1.071|0.916|0.814
72616693|NCT03446573|144764464|OTHER||Treatment ratio|0.958||||0.56|TWO_SIDED|95.0|0.83|1.106|||Mixed Model Repeated Measures||Treatment ratio (DTG+3TC/ TAF based regimen) and 95% CI for Urine beta-2 microglobulin/urine creatinine at Week 24 has been presented.|||1.106|0.830|0.560
72616694|NCT03446573|144764464|OTHER||Treatment ratio|1.055||||0.489|TWO_SIDED|95.0|0.906|1.229|||Mixed Model Repeated Measures||Treatment ratio (DTG+3TC/ TAF based regimen) and 95% CI for Urine beta-2 microglobulin/urine creatinine at Week 48 has been presented.|||1.229|0.906|0.489
72616695|NCT03446573|144764466|OTHER||Treatment ratio|1.165||||0.081|TWO_SIDED|95.0|0.981|1.384|||Mixed Model Repeated Measures||Treatment ratio (DTG+3TC/ TAF based regimen) and 95% CI for Urine beta-2 microglobulin/urine creatinine at Week 96 has been presented.|||1.384|0.981|0.081
72616696|NCT03446573|144764466|OTHER||Treatment ratio|0.981||||0.834|TWO_SIDED|95.0|0.819|1.175|||Mixed Model Repeated Measures||Treatment ratio (DTG+3TC/ TAF based regimen) and 95% CI for Urine beta-2 microglobulin/urine creatinine at Week 144 has been presented.|||1.175|0.819|0.834
72616697|NCT03446573|144764467|OTHER||Treatment ratio|1.017||||0.758|TWO_SIDED|95.0|0.915|1.13|||Mixed Model Repeated Measures||Treatment ratio (DTG+3TC/ TAF based regimen) and 95% CI for Urine phosphate at Week 24 has been presented.|||1.130|0.915|0.758
72616698|NCT03446573|144764467|OTHER||Treatment ratio|0.999||||0.985|TWO_SIDED|95.0|0.894|1.116|||Mixed Model Repeated Measures||Treatment ratio (DTG+3TC/ TAF based regimen) and 95% CI for Urine phosphate at Week 48 has been presented.|||1.116|0.894|0.985
72616699|NCT03446573|144764469|OTHER||Treatment ratio|1.015||||0.806|TWO_SIDED|95.0|0.904|1.139|||Mixed Model Repeated Measures||Treatment ratio (DTG+3TC/ TAF based regimen) and 95% CI for Urine phosphate at Week 96 has been presented.|||1.139|0.904|0.806
72616700|NCT03446573|144764469|OTHER||Treatment ratio|1.019||||0.745|TWO_SIDED|95.0|0.909|1.142|||Mixed Model Repeated Measures||Treatment ratio (DTG+3TC/ TAF based regimen) and 95% CI for Urine phosphate at Week 144 has been presented.|||1.142|0.909|0.745
72616701|NCT03446573|144764470|OTHER||Treatment ratio|0.935||||0.264|TWO_SIDED|95.0|0.83|1.052|||Mixed Model Reported Measures||Treatment ratio (DTG+3TC/ TAF based regimen) and 95% CI for Urine retinol binding protein 4/urine creatinine at Week 24 has been presented.|||1.052|0.830|0.264
72616702|NCT03446573|144764470|OTHER||Treatment ratio|0.996||||0.932|TWO_SIDED|95.0|0.903|1.098|||Mixed Model Repeated Measures||Treatment ratio (DTG+3TC/ TAF based regimen) and 95% CI for Urine retinol binding protein 4/urine creatinine at Week 48 has been presented.|||1.098|0.903|0.932
72616703|NCT03446573|144764472|OTHER||Treatment ratio|1.15||||0.011|TWO_SIDED|95.0|1.032|1.281|||Mixed Model Repeated Measures||Treatment ratio (DTG+3TC/ TAF based regimen) and 95% CI for Urine retinol binding protein 4/urine creatinine at Week 96 has been presented.|||1.281|1.032|0.011
72616704|NCT03446573|144764472|OTHER||Treatment ratio|1.007||||0.895|TWO_SIDED|95.0|0.905|1.121|||Mixed Model Repeated Measures||Treatment ratio (DTG+3TC/ TAF based regimen) and 95% CI for Urine retinol binding protein 4/urine creatinine at Week 144 has been presented.|||1.121|0.905|0.895
72616705|NCT03446573|144764480|OTHER||Mean Difference (Net)|0.29||||0.047|TWO_SIDED|95.0|0.0|0.57|||Mixed Model Repeated Measures||Mean difference (DTG+3TC - TAF based regimen) and its 95% CI for Bone-ALP at Week 24 has been presented|||0.57|0.00|0.047
72616706|NCT03446573|144764480|OTHER||Mean Difference (Net)|0.31||||0.094|TWO_SIDED|95.0|-0.05|0.68|||Mixed Model Repeated Measures||Mean difference (DTG+3TC - TAF based regimen) and its 95% CI for Bone-ALP at Week 48 has been presented|||0.68|-0.05|0.094
72616707|NCT03446573|144764480|OTHER||Mean Difference (Net)|-1.34|||<|0.001|TWO_SIDED|95.0|-2.01|-0.68|||Mixed Model Repeated Measures||Mean difference (DTG+3TC - TAF based regimen) and its 95% CI for Osteocalcin at Week 24 has been presented|||-0.68|-2.01|<0.001
72616708|NCT03446573|144764480|OTHER||Mean Difference (Net)|-1.84|||<|0.001|TWO_SIDED|95.0|-2.59|-1.09|||Mixed Model Repeated Measures||Mean difference (DTG+3TC - TAF based regimen) and its 95% CI for Osteocalcin at Week 48 has been presented|||-1.09|-2.59|<0.001
72616709|NCT03446573|144764480|OTHER||Mean Difference (Net)|2.1||||0.066|TWO_SIDED|95.0|-0.1|4.3|||Mixed Model Repeated Measures||Mean difference (DTG+3TC - TAF based regimen) and its 95% CI for P1NP at Week 24 has been presented|||4.3|-0.1|0.066
72616710|NCT03446573|144764480|OTHER||Mean Difference (Net)|2.9||||0.046|TWO_SIDED|95.0|0.0|5.8|||Mixed Model Repeated Measures||Mean difference (DTG+3TC - TAF based regimen) and its 95% CI for P1NP at Week 48 has been presented|||5.8|0.0|0.046
72616711|NCT03446573|144764480|OTHER||Mean Difference (Net)|0.0381||||0.005|TWO_SIDED|95.0|0.0117|0.0646|||Mixed Model Repeated Measures||Mean difference (DTG+3TC - TAF based regimen) and its 95% CI for CTX-1 at Week 24 has been presented|||0.0646|0.0117|0.005
72616712|NCT03446573|144764480|OTHER||Mean Difference (Net)|0.0292||||0.032|TWO_SIDED|95.0|0.0025|0.0559|||Mixed Model Repeated Measures||Mean difference (DTG+3TC - TAF based regimen) and its 95% CI for CTX-1 at Week 48 has been presented|||0.0559|0.0025|0.032
72616713|NCT03446573|144764482|OTHER||Mean Difference (Net)|0.17||||0.386|TWO_SIDED|95.0|-0.22|0.57|||Mixed Model Repeated Measures||Mean difference (DTG+3TC - TAF based regimen) and its 95% CI for Bone-ALP at Week 96 has been presented|||0.57|-0.22|0.386
72616714|NCT03446573|144764482|OTHER||Mean Difference (Net)|0.14||||0.573|TWO_SIDED|95.0|-0.34|0.61|||Mixed Model Repeated Measures||Mean difference (DTG+3TC - TAF based regimen) and its 95% CI for Bone-ALP at Week 144 has been presented|||0.61|-0.34|0.573
72616715|NCT03446573|144764482|OTHER||Mean Difference (Net)|-1.87|||<|0.001|TWO_SIDED|95.0|-2.7|-1.04|||Mixed Model Repeated Measures||Mean difference (DTG+3TC - TAF based regimen) and its 95% CI for Osteocalcin at Week 96 has been presented|||-1.04|-2.70|< 0.001
72616716|NCT03446573|144764482|OTHER||Mean Difference (Net)|-1.95|||<|0.001|TWO_SIDED|95.0|-2.77|-1.14|||Mixed Model Repeated Measures||Mean difference (DTG+3TC - TAF based regimen) and its 95% CI for Osteocalcin at Week 144 has been presented|||-1.14|-2.77|< 0.001
72616717|NCT03446573|144764482|OTHER||Mean Difference (Net)|2.1||||0.082|TWO_SIDED|95.0|-0.3|4.4|||Mixed Model Repeated Measures||Mean difference (DTG+3TC - TAF based regimen) and its 95% CI for P1NP at Week 96 has been presented.|||4.4|-0.3|0.082
72616718|NCT03446573|144764482|OTHER||Mean Difference (Net)|0.4||||0.765|TWO_SIDED|95.0|-2.3|3.2|||Mixed Model Repeated Measures||Mean difference (DTG+3TC - TAF based regimen) and its 95% CI for P1NP at Week 144 has been presented|||3.2|-2.3|0.765
72616719|NCT03446573|144764482|OTHER||Mean Difference (Net)|0.0151||||0.301|TWO_SIDED|95.0|-0.0136|0.0438|||Mixed Model Repeated Measures||Mean difference (DTG+3TC - TAF based regimen) and its 95% CI for CTX-1 at Week 96 has been presented|||0.0438|-0.0136|0.301
72616720|NCT03446573|144764482|OTHER||Mean Difference (Net)|0.0126||||0.34|TWO_SIDED|95.0|-0.0133|0.0384|||Mixed Model Repeated Measures||Mean difference (DTG+3TC - TAF based regimen) and its 95% CI for CTX-1 at Week 144 has been presented|||0.0384|-0.0133|0.340
72616721|NCT03446573|144764483|OTHER||Mean Difference (Net)|-2.2||||0.173|TWO_SIDED|95.0|-5.3|1.0|||Mixed Model Repeated Measures||Mean difference (DTG+3TC - TAF based regimen) and its 95% CI for serum 25 hydroxyvitamin D at Week 24 has been presented|||1.0|-5.3|0.173
72616722|NCT03446573|144764483|OTHER||Mean Difference (Net)|-2.3||||0.168|TWO_SIDED|95.0|-5.5|1.0|||Mixed Model Repeated Measures||Mean difference (DTG+3TC - TAF based regimen) and its 95% CI for serum 25 hydroxyvitamin D at Week 48 has been presented|||1.0|-5.5|0.168
72616723|NCT03446573|144764485|OTHER||Mean Difference (Net)|-9.4|||<|0.001|TWO_SIDED|95.0|-14.0|-4.7|||Mixed Model Repeated Measures||Mean difference (DTG+3TC - TAF based regimen) and its 95% CI for serum 25 hydroxyvitamin D at Week 96 has been presented.|||-4.7|-14.0|<0.001
72616724|NCT03446573|144764485|OTHER||Mean Difference (Net)|-5.6||||0.005|TWO_SIDED|95.0|-9.4|-1.7|||Mixed Model Repeated Measures||Mean difference (DTG+3TC - TAF based regimen) and its 95% CI for serum 25 hydroxyvitamin D at Week 144 has been presented.|||-1.7|-9.4|0.005
72616725|NCT03446573|144764486|OTHER||Mean Difference (Net)|-0.01||||0.027|TWO_SIDED|95.0|-0.03|0.0|||Mixed Model Repeated Measures||Mean difference (DTG+3TC - TAF based regimen) and its 95% CI for serum cystatin C at Week 24 has been presented|||0.00|-0.03|0.027
72616726|NCT03446573|144764486|OTHER||Mean Difference (Net)|-0.01||||0.061|TWO_SIDED|95.0|-0.03|0.0|||Mixed Model Repeated Measures||Mean difference (DTG+3TC - TAF based regimen) and its 95% CI for serum cystatin C at Week 48 has been presented|||0.00|-0.03|0.061
72616727|NCT03446573|144764488|OTHER||Mean Difference (Net)|-0.03||||0.004|TWO_SIDED|95.0|-0.06|-0.01|||Mixed Model Repeated Measures||Mean difference (DTG+3TC - TAF based regimen) and its 95% CI for serum cystatin C at Week 96 has been presented|||-0.01|-0.06|0.004
72371607|NCT00669409|144253447|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-13.7|STANDARD_ERROR_OF_MEAN|10.48|||TWO_SIDED|95.0|-34.4|7.0||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||7.0|-34.4|
72371608|NCT00669409|144253448|SUPERIORITY_OR_OTHER_LEGACY||Least Mean Square Difference|11.0|STANDARD_ERROR_OF_MEAN|7.98|||TWO_SIDED|95.0|-4.8|26.8||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||26.8|-4.8|
72616728|NCT03446573|144764488|OTHER||Mean Difference (Net)|-0.01||||0.094|TWO_SIDED|95.0|-0.03|0.0|||Mixed Model Repeated Measures||Mean difference (DTG+3TC - TAF based regimen) and its 95% CI for serum cystatin C at Week 144 has been presented|||0.00|-0.03|0.094
72616729|NCT03446573|144764489|OTHER||Mean Difference (Net)|1.8||||0.012|TWO_SIDED|95.0|0.4|3.1|||Mixed Model Repeated Measures||Mean difference (DTG+3TC - TAF based regimen) and its 95% CI for serum GFR from cystatin C adjusted using CKD-EPI at Week 24 has been presented|||3.1|0.4|0.012
72616730|NCT03446573|144764489|OTHER||Mean Difference (Net)|1.6||||0.059|TWO_SIDED|95.0|-0.1|3.3|||Mixed Model Repeated Measures||Mean difference (DTG+3TC - TAF based regimen) and its 95% CI for serum GFR from cystatin C adjusted using CKD-EPI at Week 48 has been presented|||3.3|-0.1|0.059
72616731|NCT03446573|144764489|OTHER||Mean Difference (Net)|-5.0|||<|0.001|TWO_SIDED|95.0|-6.3|-3.7|||Mixed Model Repeated Measures||Mean difference (DTG+3TC - TAF based regimen) and its 95% CI for serum GFR from creatinine adjusted using CKD-EPI at Week 24 has been presented|||-3.7|-6.3|<0.001
72616732|NCT03446573|144764489|OTHER||Mean Difference (Net)|-4.8|||<|0.001|TWO_SIDED|95.0|-6.1|-3.4|||Mixed Model Repeated Measures||Mean difference (DTG+3TC - TAF based regimen) and its 95% CI for serum GFR from creatinine adjusted using CKD-EPI at Week 48 has been presented|||-3.4|-6.1|<0.001
72616733|NCT03446573|144764491|OTHER||Mean Difference (Net)|4.1||||0.002|TWO_SIDED|95.0|1.5|6.7|||Mixed Model Repeated Measures||Mean difference (DTG+3TC - TAF based regimen) and its 95% CI for serum GFR from cystatin C adjusted using CKD-EPI at Week 96 has been presented|||6.7|1.5|0.002
72616734|NCT03446573|144764491|OTHER||Mean Difference (Net)|1.9||||0.064|TWO_SIDED|95.0|-0.1|3.8|||Mixed Model Repeated Measures||Mean difference (DTG+3TC - TAF based regimen) and its 95% CI for serum GFR from cystatin C adjusted using CKD-EPI at Week 148 has been presented|||3.8|-0.1|0.064
72616735|NCT03446573|144764491|OTHER||Mean Difference (Net)|-5.2|||<|0.001|TWO_SIDED|95.0|-6.7|-3.8|||Mixed Model Repeated Measures||Mean difference (DTG+3TC - TAF based regimen) and its 95% CI for serum GFR from creatinine adjusted using CKD-EPI at Week 96 has been presented|||-3.8|-6.7|<0.001
72616736|NCT03446573|144764491|OTHER||Mean Difference (Net)|-4.5|||<|0.001|TWO_SIDED|95.0|-6.2|-2.8|||Mixed Model Repeated Measures||Mean difference (DTG+3TC - TAF based regimen) and its 95% CI for serum GFR from creatinine adjusted using CKD-EPI at Week 144 has been presented|||-2.8|-6.2|<0.001
72616737|NCT03446573|144764492|OTHER||Mean Difference (Net)|4.37|||<|0.001|TWO_SIDED|95.0|3.03|5.7|||Mixed Model Repeated Measures||Mean difference (DTG+3TC - TBR) and its 95% CI for serum creatinine at Week 24 has been presented.|||5.70|3.03|<0.001
72616738|NCT03446573|144764492|OTHER||Mean Difference (Net)|4.49|||<|0.001|TWO_SIDED|95.0|3.18|5.81|||Mixed Model Repeated Measures||Mean difference (DTG+3TC - TBR) and its 95% CI for serum creatinine at Week 48 has been presented.|||5.81|3.18|<0.001
72616739|NCT03446573|144764494|OTHER||Mean Difference (Net)|4.95|||<|0.001|TWO_SIDED|95.0|3.47|6.43|||Mixed Model Repeated Measures||Mean difference (DTG+3TC - TBR) and its 95% CI for serum creatinine at Week 96 has been presented.|||6.43|3.47|<0.001
72616740|NCT03446573|144764494|OTHER||Mean Difference (Net)|4.08|||<|0.001|TWO_SIDED|95.0|2.32|5.85|||Mixed Model Repeated Measures||Mean difference (DTG+3TC - TBR) and its 95% CI for serum creatinine at Week 144 has been presented.|||5.85|2.32|<0.001
72616741|NCT03446573|144764495|OTHER||Mean Difference (Net)|-0.0017||||0.741|TWO_SIDED|95.0|-0.0119|0.0085|||Mixed Model Repeated Measures||Week 24. MMRM adjusted for following: Treatment, Visit, Baseline Third Agent Class, Baseline EQ-5D Utility (continuous), Treatment by Visit interaction, and Baseline EQ-5D Utility by Visit interaction, with Visit as the repeated factor.|||0.0085|-0.0119|0.741
72616742|NCT03446573|144764495|OTHER||Mean Difference (Net)|0.0015||||0.792|TWO_SIDED|95.0|-0.0094|0.0123|||Mixed Model Repeated Measures||Week 48. MMRM adjusted for following: Treatment, Visit, Baseline Third Agent Class, Baseline EQ-5D Utility (continuous), Treatment by Visit interaction, and Baseline EQ-5D Utility by Visit interaction, with Visit as the repeated factor.|||0.0123|-0.0094|0.792
72616743|NCT03446573|144764496|OTHER||Mean Difference (Net)|0.0003||||0.965|TWO_SIDED|95.0|-0.0121|0.0126|||Mixed Model Repeated Measures||Week 96. MMRM adjusted for following: Treatment, Visit, Baseline Third Agent Class, Baseline EQ-5D Utility (continuous), Treatment by Visit interaction, and Baseline EQ-5D Utility by Visit interaction, with Visit as the repeated factor.|||0.0126|-0.0121|0.965
72616744|NCT03446573|144764496|OTHER||Mean Difference (Net)|-0.0109||||0.12|TWO_SIDED|95.0|-0.0247|0.0029|||Mixed Model Repeated Measures||Week 144. MMRM adjusted for following: Treatment, Visit, Baseline Third Agent Class, Baseline EQ-5D Utility (continuous), Treatment by Visit interaction, and Baseline EQ-5D Utility by Visit interaction, with Visit as the repeated factor.|||0.0029|-0.0247|0.120
72616745|NCT03446573|144764497|OTHER||Mean Difference (Net)|-0.1||||0.879|TWO_SIDED|95.0|-1.4|1.2|||Mixed Model Repeated Measures||Week 24. MMRM adjusted for following: Treatment, Visit, Baseline Third Agent Class, Baseline EQ-5D Thermometer (continuous), Treatment by Visit interaction, and Baseline EQ-5D Thermometer by Visit interaction, with Visit as the repeated factor.|||1.2|-1.4|0.879
72616746|NCT03446573|144764497|OTHER||Mean Difference (Net)|-0.5||||0.414|TWO_SIDED|95.0|-1.9|0.8|||Mixed Model Repeated Measures||Week 48. MMRM adjusted for following: Treatment, Visit, Baseline Third Agent Class, Baseline EQ-5D Thermometer (continuous), Treatment by Visit interaction, and Baseline EQ-5D Thermometer by Visit interaction, with Visit as the repeated factor.|||0.8|-1.9|0.414
72616747|NCT03446573|144764498|OTHER||Mean Difference (Net)|-1.2||||0.102|TWO_SIDED|95.0|-2.5|0.2|||Mixed Model Repeated Measures||Week 96. MMRM adjusted for following: Treatment, Visit, Baseline Third Agent Class, Baseline EQ-5D Thermometer (continuous), Treatment by Visit interaction, and Baseline EQ-5D Thermometer by Visit interaction, with Visit as the repeated factor.|||0.2|-2.5|0.102
72616748|NCT03446573|144764498|OTHER||Mean Difference (Net)|-1.3||||0.093|TWO_SIDED|95.0|-2.8|0.2|||Mixed Model Repeated Measures||Week 144. MMRM adjusted for following: Treatment, Visit, Baseline Third Agent Class, Baseline EQ-5D Thermometer (continuous), Treatment by Visit interaction, and Baseline EQ-5D Thermometer by Visit interaction, with Visit as the repeated factor.|||0.2|-2.8|0.093
72616749|NCT04270760|144764502|SUPERIORITY||Treatment difference|-70.51|STANDARD_ERROR_OF_MEAN|2.35|<|0.001|TWO_SIDED|95.0|-75.12|-65.9||Adjusted p-value is reported based on the Hochberg procedure to control the type I error for multiple comparisons. Each individual adjusted p-value is compared to 0.05 to determine statistical significance.|Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment group with scheduled visit as covariates.|Treatment difference = percentage change in Group 1 - percentage change in Group 5 from Baseline at Week 36.|Group 1 versus (vs) Group 5||-65.90|-75.12|<0.001
72616750|NCT04270760|144764502|SUPERIORITY||Treatment difference|-97.38|STANDARD_ERROR_OF_MEAN|2.35|<|0.001|TWO_SIDED|95.0|-101.98|-92.77||Adjusted p-value is reported based on the Hochberg procedure to control the type I error for multiple comparisons. Each individual adjusted p-value is compared to 0.05 to determine statistical significance.|Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment group with scheduled visit as covariates.|Treatment difference = percentage change in Group 2 - percentage change in Group 5 from Baseline at Week 36.|Group 2 vs Group 5||-92.77|-101.98|<0.001
72616751|NCT04270760|144764502|SUPERIORITY||Treatment difference|-101.13|STANDARD_ERROR_OF_MEAN|2.38|<|0.001|TWO_SIDED|95.0|-105.79|-96.47||Adjusted p-value is reported based on the Hochberg procedure to control the type I error for multiple comparisons. Each individual adjusted p-value is compared to 0.05 to determine statistical significance.|Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment group with scheduled visit as covariates.|Treatment difference = percentage change in Group 3 - percentage change in Group 5 from Baseline at Week 36.|Group 3 vs Group 5||-96.47|-105.79|<0.001
72616752|NCT04270760|144764502|SUPERIORITY||Treatment difference|-100.49|STANDARD_ERROR_OF_MEAN|2.38|<|0.001|TWO_SIDED|95.0|-105.16|-95.82|||Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment group with scheduled visit as covariates.|Treatment difference = percentage change in Group 4 - percentage change in Group 5 from Baseline at Week 36.|Group 4 vs Group 5||-95.82|-105.16|< 0.001
72616753|NCT04270760|144764503|SUPERIORITY||Treatment difference|-68.47|STANDARD_ERROR_OF_MEAN|2.96|<|0.001|TWO_SIDED|95.0|-74.27|-62.67|||Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment group with scheduled visit as covariates.|Treatment difference = percentage change in Group 1 - percentage change in Group 5 from Baseline at Week 48.|Group 1 vs Group 5||-62.67|-74.27|<0.001
72616754|NCT04270760|144764503|SUPERIORITY||Treatment difference|-96.12|STANDARD_ERROR_OF_MEAN|2.96|<|0.001|TWO_SIDED|95.0|-101.92|-90.33|||Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment group with scheduled visit as covariates.|Treatment difference = percentage change in Group 2 - percentage change in Group 5 from Baseline at Week 48.|Group 2 vs Group 5||-90.33|-101.92|<0.001
72616755|NCT04270760|144764503|SUPERIORITY||Treatment difference|-100.88|STANDARD_ERROR_OF_MEAN|2.99|<|0.001|TWO_SIDED|95.0|-106.74|-95.02|||Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment group with scheduled visit as covariates.|Treatment difference = percentage change in Group 3 - percentage change in Group 5 from Baseline at Week 48.|Group 3 vs Group 5||-95.02|-106.74|<0.001
72616756|NCT04270760|144764503|SUPERIORITY||Treatment difference|-85.94|STANDARD_ERROR_OF_MEAN|3.0|<|0.001|TWO_SIDED|95.0|-91.83|-80.06|||Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment group with scheduled visit as covariates.|Treatment difference = percentage change in Group 4 - percentage change in Group 5 from Baseline at Week 48.|Group 4 vs Group 5||-80.06|-91.83|< 0.001
72616757|NCT04270760|144764504|SUPERIORITY||Treatment difference|-23.659|STANDARD_ERROR_OF_MEAN|5.874|<|0.001|TWO_SIDED|95.0|-35.176|-12.143|||Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment group with scheduled visit as covariates.|Treatment difference = percentage change in Group 1 - percentage change in Group 5 from Baseline at Week 36.|Week 36: Group 1 vs Group 5||-12.143|-35.176|<0.001
72616758|NCT04270760|144764504|SUPERIORITY||Treatment difference|-22.518|STANDARD_ERROR_OF_MEAN|5.875|<|0.001|TWO_SIDED|95.0|-34.036|-11.0|||Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment group with scheduled visit as covariates.|Treatment difference = percentage change in Group 2 - percentage change in Group 5 from Baseline at Week 36.|Week 36: Group 2 vs Group 5||-11.000|-34.036|<0.001
72616759|NCT04270760|144764504|SUPERIORITY||Treatment difference|-22.967|STANDARD_ERROR_OF_MEAN|5.962|<|0.001|TWO_SIDED|95.0|-34.656|-11.278|||Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment group with scheduled visit as covariates.|Treatment difference = percentage change in Group 3 - percentage change in Group 5 from Baseline at Week 36.|Week 36: Group 3 vs Group 5||-11.278|-34.656|<0.001
72616760|NCT04270760|144764504|SUPERIORITY||Treatment difference|-24.696|STANDARD_ERROR_OF_MEAN|5.969|<|0.001|TWO_SIDED|95.0|-36.399|-12.993|||Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment group with scheduled visit as covariates.|Treatment difference = percentage change in Group 4 - percentage change in Group 5 from Baseline at Week 36.|Week 36: Group 4 vs Group 5||-12.993|-36.399|< 0.001
72616761|NCT04270760|144764504|SUPERIORITY||Treatment difference|-24.856|STANDARD_ERROR_OF_MEAN|6.119|<|0.001|TWO_SIDED|95.0|-36.853|-12.859|||Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment group with scheduled visit as covariates.|Treatment difference = percentage change in Group 1 - percentage change in Group 5 from Baseline at Week 48.|Week 48: Group 1 vs Group 5||-12.859|-36.853|<0.001
72616762|NCT04270760|144764504|SUPERIORITY||Treatment difference|-21.594|STANDARD_ERROR_OF_MEAN|6.118|<|0.001|TWO_SIDED|95.0|-33.59|-9.598|||Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment group with scheduled visit as covariates.|Treatment difference = percentage change in Group 2 - percentage change in Group 5 from Baseline at Week 48.|Week 48: Group 2 vs Group 5||-9.598|-33.590|<0.001
72371609|NCT00669409|144253448|SUPERIORITY_OR_OTHER_LEGACY||Least Mean Square Difference|-8.1|STANDARD_ERROR_OF_MEAN|7.98|||TWO_SIDED|95.0|-23.9|7.6||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||7.6|-23.9|
72616763|NCT04270760|144764504|SUPERIORITY||Treatment difference|-27.421|STANDARD_ERROR_OF_MEAN|6.194|<|0.001|TWO_SIDED|95.0|-39.565|-15.277|||Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment group with scheduled visit as covariates.|Treatment difference = percentage change in Group 3 - percentage change in Group 5 from Baseline at Week 48.|Week 48: Group 3 vs Group 5||-15.277|-39.565|<0.001
72616764|NCT04270760|144764504|SUPERIORITY||Treatment difference|-27.021|STANDARD_ERROR_OF_MEAN|6.232|<|0.001|TWO_SIDED|95.0|-39.24|-14.801|||Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment group with scheduled visit as covariates.|Treatment difference = percentage change in Group 4 - percentage change in Group 5 from Baseline at Week 48.|Week 48: Group 4 vs Group 5||-14.801|-39.240|<0.001
72616765|NCT04270760|144764505|SUPERIORITY||Treatment difference|-18.89|STANDARD_ERROR_OF_MEAN|3.779|<|0.001|TWO_SIDED|95.0|-26.303|-11.477|||Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment group with scheduled visit as covariates.|Treatment difference = percentage change in Group 1 - percentage change in Group 5 from Baseline at Week 36.|Week 36: Group 1 vs Group 5||-11.477|-26.303|<0.001
72616766|NCT04270760|144764505|SUPERIORITY||Treatment difference|-16.696|STANDARD_ERROR_OF_MEAN|3.778|<|0.001|TWO_SIDED|95.0|-24.107|-9.284|||Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment group with scheduled visit as covariates.|Treatment difference = percentage change in Group 2 - percentage change in Group 5 from Baseline at Week 36.|Week 36: Group 2 vs Group 5||-9.284|-24.107|<0.001
72616767|NCT04270760|144764505|SUPERIORITY||Treatment difference|-17.635|STANDARD_ERROR_OF_MEAN|3.825|<|0.001|TWO_SIDED|95.0|-25.139|-10.131|||Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment group with scheduled visit as covariates.|Treatment difference = percentage change in Group 3 - percentage change in Group 5 from Baseline at Week 36.|Week 36: Group 3 vs Group 5||-10.131|-25.139|<0.001
72616768|NCT04270760|144764505|SUPERIORITY||Treatment difference|-18.772|STANDARD_ERROR_OF_MEAN|3.839|<|0.001|TWO_SIDED|95.0|-26.303|-11.241|||Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment group with scheduled visit as covariates.|Treatment difference = percentage change in Group 4 - percentage change in Group 5 from Baseline at Week 36.|Week 36: Group 4 vs Group 5||-11.241|-26.303|< 0.001
72616769|NCT04270760|144764505|SUPERIORITY||Treatment difference|-20.04|STANDARD_ERROR_OF_MEAN|4.443|<|0.001|TWO_SIDED|95.0|-28.757|-11.323|||Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment group with scheduled visit as covariates.|Treatment difference = percentage change in Group 1 - percentage change in Group 5 from Baseline at Week 48.|Week 48: Group 1 vs Group 5||-11.323|-28.757|<0.001
72616770|NCT04270760|144764505|SUPERIORITY||Treatment difference|-17.06|STANDARD_ERROR_OF_MEAN|4.442|<|0.001|TWO_SIDED|95.0|-25.774|-8.345|||Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment group with scheduled visit as covariates.|Treatment difference = percentage change in Group 2 - percentage change in Group 5 from Baseline at Week 48.|Week 48: Group 2 vs Group 5||-8.345|-25.774|<0.001
72616771|NCT04270760|144764505|SUPERIORITY||Treatment difference|-19.509|STANDARD_ERROR_OF_MEAN|4.5|<|0.001|TWO_SIDED|95.0|-28.336|-10.682|||Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment group with scheduled visit as covariates.|Treatment difference = percentage change in Group 3 - percentage change in Group 5 from Baseline at Week 48.|Week 48: Group 3 vs Group 5||-10.682|-28.336|<0.001
72616772|NCT04270760|144764505|SUPERIORITY||Treatment difference|-21.839|STANDARD_ERROR_OF_MEAN|4.517|<|0.001|TWO_SIDED|95.0|-30.7|-12.979|||Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment group with scheduled visit as covariates.|Treatment difference = percentage change in Group 4 - percentage change in Group 5 from Baseline at Week 48.|Week 48: Group 4 vs Group 5||-12.979|-30.700|<0.001
72616773|NCT02070991|144764507|SUPERIORITY_OR_OTHER||Difference between maci. and placebo|10.08||||0.3372|TWO_SIDED|95.0|-15.07|33.26|||Fisher Exact|||||33.26|-15.07|0.3372
72616774|NCT02070991|144764508|SUPERIORITY_OR_OTHER||Treatment effect (ratio of geom. means)|0.77|||||TWO_SIDED|95.0|0.55|1.08||||||||1.08|0.55|
72616775|NCT02070991|144764509|SUPERIORITY_OR_OTHER||Treatment effect (ratio of geom. means)|0.93|||||TWO_SIDED|95.0|0.64|1.36||||||||1.36|0.64|
72616776|NCT02070991|144764510|SUPERIORITY_OR_OTHER||Treatment effect (mean change from BL)|0.3|||||TWO_SIDED|95.0|-4.3|4.9||||||||4.9|-4.3|
72616777|NCT02070991|144764511|SUPERIORITY_OR_OTHER||Treatment effect (mean change from BL)|0.7|||||TWO_SIDED|95.0|-2.2|3.6||||||||3.6|-2.2|
72616778|NCT02070991|144764512|SUPERIORITY_OR_OTHER||Treatment effect (mean change from BL)|-0.3|||||TWO_SIDED|95.0|-4.2|3.7||||||||3.7|-4.2|
72616779|NCT02070991|144764513|SUPERIORITY_OR_OTHER||Treatment effect (mean change from BL)|0.4|||||TWO_SIDED|95.0|0.11|0.69||||||||0.69|0.11|
72616780|NCT02070991|144764514|SUPERIORITY_OR_OTHER||Treatment effect (mean change from BL)|-0.4|||||TWO_SIDED|95.0|-4.5|3.6||||||||3.6|-4.5|
72616781|NCT02421510|144764515|SUPERIORITY||Least squares mean difference|-0.37|STANDARD_ERROR_OF_MEAN|0.058|<|0.001|TWO_SIDED|95.0|-0.48|-0.25||Threshold for significance \<= 0.05|MMRM||Sotagliflozin 200 mg versus Placebo|LS means and p-values were obtained from MMRM model with treatment, randomization strata of insulin delivery (MDI, CSII) and Week -2 A1C (\<= 8.5%, \>8.5%), time (study week), and a treatment-by-time interaction as fixed categorical effects, and baseline A1C-by-time interaction as a covariate.||-0.25|-0.48|< 0.001
72616782|NCT02421510|144764515|SUPERIORITY||Least squares mean difference|-0.35|||<|0.001|TWO_SIDED|95.0|-0.47|-0.24||Threshold for significance \<= 0.05|MMRM||Sotagliflozin 400 mg versus Placebo|LS means and p-values were obtained from Mixed effect Model Repeat Measurement (MMRM) model with treatment, randomization strata of insulin delivery (MDI, CSII) and Week -2 A1C (\<= 8.5%, \>8.5%), time (study week), and a treatment-by-time interaction as fixed categorical effects, and baseline A1C- by-time interaction as a covariate.||-0.24|-0.47|< 0.001
72616783|NCT02421510|144764516|SUPERIORITY|A hierarchical testing procedure was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially in the order the endpoints were reported. The hierarchical testing sequence continued only when previous endpoint was statistically significant at 0.05 level.|Percentage difference|16.3|||<|0.001|TWO_SIDED|95.0|9.17|23.43||Threshold for significance \<= 0.05|Cochran-Mantel-Haenszel||Sotagliflozin 200 mg versus Placebo|P-values were obtained from a Cochran-Mantel-Haenszel (CMH) test stratified by the different levels of the randomization stratification factors of insulin delivery method (MDI, CSII) and Week -2 A1C (\<=8.5%, \>8.5%). The 95% Confidence Limits (CL) were calculated using asymptotic Wald method. Only positively adjudicated severe hypoglycemia and diabetic ketoacidosis were included in the analysis.||23.43|9.17|< 0.001
72616784|NCT02421510|144764516|SUPERIORITY|A hierarchical testing procedure was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially in the order the endpoints were reported. The hierarchical testing sequence continued only when previous endpoint was statistically significant at 0.05 level.|Percentage difference|17.2|||<|0.001|TWO_SIDED|95.0|10.06|24.35||Threshold for significance \<= 0.05|Cochran-Mantel-Haenszel||Sotagliflozin 400 mg versus Placebo|P-values were obtained from a CMH test stratified by the different levels of the randomization stratification factors of insulin delivery method (MDI, CSII) and Week -2 A1C (\<= 8.5%, \>8.5%). The 95% CL were calculated using asymptotic Wald method.||24.35|10.06|< 0.001
72616785|NCT02421510|144764517|SUPERIORITY|A hierarchical testing procedure was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially in the order the endpoints were reported. The hierarchical testing sequence continued only when previous endpoint was statistically significant at 0.05 level.|Least squares mean difference|-1.98|STANDARD_ERROR_OF_MEAN|0.276|<|0.001|TWO_SIDED|95.0|-2.53|-1.44||Threshold for significance \<= 0.05|MMRM||Sotagliflozin 200 mg versus Placebo|LS means and p-values were obtained from MMRM model with treatment, randomization strata of insulin delivery (MDI, CSII) and Week -2 A1C (\<= 8.5%, \>8.5%), time (study week), and a treatment-by-time interaction as fixed categorical effects.||-1.44|-2.53|< 0.001
72616786|NCT02421510|144764517|SUPERIORITY|A hierarchical testing procedure was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially in the order the endpoints were reported. The hierarchical testing sequence continued only when previous endpoint was statistically significant at 0.05 level.|Least squares mean difference|-2.58|STANDARD_ERROR_OF_MEAN|0.276|<|0.001|TWO_SIDED|95.0|-3.12|-2.04|||MMRM||Sotagliflozin 400 mg versus Placebo|LS means and p-values were obtained from MMRM model with treatment, randomization strata of insulin delivery (MDI, CSII) and Week -2 A1C (\<= 8.5%, \>8.5%), time (study week), and a treatment-by-time interaction as fixed categorical effects.||-2.04|-3.12|< 0.001
72616787|NCT02421510|144764518|SUPERIORITY|A hierarchical testing procedure was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially in the order the endpoints were reported. The hierarchical testing sequence continued only when previous endpoint was statistically significant at 0.05 level.|Least squares mean difference|-3.2|STANDARD_ERROR_OF_MEAN|0.847|<|0.001|TWO_SIDED|95.0|-4.86|-1.53||Threshold for significance \<=0.05|MMRM||Sotagliflozin 200 mg versus Placebo|LS means and p-values were obtained from MMRM model with treatment, randomization strata of insulin delivery (MDI, CSII) and Week -2 A1C (\<= 8.5%, \>8.5%), time (study week), and a treatment-by-time interaction as fixed categorical effects, and Baseline mean daily bolus insulin dose-by-time interaction as a covariate.||-1.53|-4.86|< 0.001
72616788|NCT02421510|144764518|SUPERIORITY|A hierarchical testing procedure was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially in the order the endpoints were reported. The hierarchical testing sequence continued only when previous endpoint was statistically significant at 0.05 level.|Least squares mean difference|-3.59|STANDARD_ERROR_OF_MEAN|0.845|<|0.001|TWO_SIDED|95.0|-5.25|-1.93||Threshold for significance \<= 0.05|MMRM||Sotagliflozin 400 mg versus Placebo|LS means and p-values were obtained from MMRM model with treatment, randomization strata of insulin delivery (MDI, CSII) and Week -2 A1C (\<= 8.5%, \>8.5%), time (study week), and a treatment-by-time interaction as fixed categorical effects, and Baseline mean daily bolus insulin dose-by-time interaction as a covariate.||-1.93|-5.25|< 0.001
72616789|NCT02421510|144764519|SUPERIORITY|A hierarchical testing procedure was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially in the order the endpoints were reported. The hierarchical testing sequence continued only when previous endpoint was statistically significant at 0.05 level.|Least squares mean difference|-21.6|STANDARD_ERROR_OF_MEAN|5.38|<|0.001|TWO_SIDED|95.0|-32.2|-11.0||Threshold for significance \<= 0.05|MMRM||Sotagliflozin 200 mg versus Placebo|LS means and p-values were obtained from MMRM model with treatment, randomization strata of insulin delivery (MDI, CSII) and Week -2 A1C (\<= 8.5%, \>8.5%), time (study week), and a treatment-by-time interaction as fixed categorical effects, and baseline Fasting Plasma Glucose-by-time interaction as a covariate.||-11|-32.2|< 0.001
72616790|NCT02421510|144764519|SUPERIORITY|A hierarchical testing procedure was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially in the order the endpoints were reported. The hierarchical testing sequence continued only when previous endpoint was statistically significant at 0.05 level.|Least squares mean difference|-25.7|STANDARD_ERROR_OF_MEAN|5.37|<|0.001|TWO_SIDED|95.0|-36.2|-15.1||Threshold for significance \<= 0.05|MMRM||Sotagliflozin 400 mg versus Placebo|LS means and p-values were obtained from MMRM model with treatment, randomization strata of insulin delivery (MDI, CSII) and Week -2 A1C (\<= 8.5%, \>8.5%), time (study week), and a treatment-by-time interaction as fixed categorical effects, and baseline Fasting Plasma Glucose-by-time interaction as a covariate.||-15.1|-36.2|< 0.001
72622274|NCT04250207|144774534|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.||||||0.0135|||||||Chi-square or Fisher exact|||Week 52||||0.0135
72622275|NCT04250207|144774534|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.||||||0.5154|||||||Chi-square or Fisher exact|||Week 52||||0.5154
72622276|NCT04250207|144774535|SUPERIORITY|||||||0.1209|||||||Log Rank|||||||0.1209
72616791|NCT02421510|144764520|SUPERIORITY|A hierarchical testing procedure was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially in the order the endpoints were reported. The hierarchical testing sequence continued only when previous endpoint was statistically significant at 0.05 level.|Least squares mean difference|2.0|STANDARD_ERROR_OF_MEAN|0.37|<|0.001|TWO_SIDED|95.0|1.3|2.7||Threshold for significance \<= 0.05.|MMRM||Sotagliflozin 200 mg versus Placebo|LS means and p-values were obtained from MMRM model with treatment, randomization strata of insulin delivery (MDI, CSII) and Week -2 A1C (\<= 8.5%, \>8.5%), time (study week), and a treatment-by-time interaction as fixed categorical effects, and baseline DTSQs total score-by-time interaction as a covariate.||2.7|1.3|< 0.001
72616792|NCT02421510|144764520|SUPERIORITY|A hierarchical testing procedure was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially in the order the endpoints were reported. The hierarchical testing sequence continued only when previous endpoint was statistically significant at 0.05 level.|Least squares mean difference|1.7|STANDARD_ERROR_OF_MEAN|0.36|<|0.001|TWO_SIDED|95.0|1.0|2.4||Threshold for significance \<= 0.05.|MMRM||Sotagliflozin 400 mg versus Placebo|LS means and p-values were obtained from MMRM model with treatment, randomization strata of insulin delivery (MDI, CSII) and Week -2 A1C (\<= 8.5%, \>8.5%), time (study week), and a treatment-by-time interaction as fixed categorical effects, and baseline DTSQs total score-by-time interaction as a covariate.||2.4|1|< 0.001
72616793|NCT02421510|144764521|SUPERIORITY|A hierarchical testing procedure was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially in the order the endpoints were reported. The hierarchical testing sequence continued only when previous endpoint was statistically significant at 0.05 level.|Least squares mean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.15||0.025|TWO_SIDED|95.0|-0.6|0.0||Threshold for significance \<= 0.05.|MMRM||Sotagliflozin 200 mg versus Placebo|LS means and p-values were obtained from MMRM model with treatment, randomization strata of insulin delivery (MDI, CSII) and Week -2 A1C (\<= 8.5%, \>8.5%), time (study week), and a treatment-by-time interaction as fixed categorical effects, and baseline DDS2 total score-by-time interaction as a covariate.||0|-0.6|0.025
72616794|NCT02421510|144764521|SUPERIORITY|A hierarchical testing procedure was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially in the order the endpoints were reported. The hierarchical testing sequence continued only when previous endpoint was statistically significant at 0.05 level.|Least squares mean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.15||0.003|TWO_SIDED|95.0|-0.7|-0.2||Threshold for significance \<= 0.05.|MMRM||Sotagliflozin 400 mg versus Placebo|LS means and p-values were obtained from MMRM model with treatment, randomization strata of insulin delivery (MDI, CSII) and Week -2 A1C (\<=8.5%, \>8.5%), time (study week), and a treatment-by-time interaction as fixed categorical effects, and baseline DDS2 total score-by-time interaction as a covariate.||-0.2|-0.7|0.003
72616795|NCT00827242|144764523|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.9|STANDARD_ERROR_OF_MEAN|0.66||0.004||95.0||||The p-value associates with LS Mean difference of changes from baseline to 12 weeks between treatment groups for IPSS. Under the pre-specified fixed sequence testing procedure, the significance level of 0.05 is used for assessment.|ANCOVA|||||||0.004
72616796|NCT00827242|144764524|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.26||0.029||95.0||||The p-value associates with LS Mean difference of changes from baseline to 4 weeks between treatment groups for BII. Under the pre-specified fixed sequence testing procedure, the significance level of 0.05 is used for assessment.|ANCOVA|||||||0.029
72616797|NCT00827242|144764525|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.3||0.057||95.0||||The p-value associates with LS Mean difference of changes from baseline to 12 weeks between treatment groups for BII. Under the pre-specified fixed sequence testing procedure, the significance level of 0.05 is used for assessment.|ANCOVA|||||||0.057
72616798|NCT00827242|144764526|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9|STANDARD_ERROR_OF_MEAN|0.3||0.002||95.0||||The p-value associates with LS Mean difference of changes from baseline to 12 weeks between treatment groups for IPSS storage subscore. Under the pre-specified fixed sequence testing procedure, the significance level of 0.05 is used for assessment.|ANCOVA|||||||0.002
72616799|NCT00827242|144764527|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0|STANDARD_ERROR_OF_MEAN|0.43||0.02||95.0||||The p-value associates with LS Mean difference of changes from baseline to 12 weeks between treatment groups for IPSS voiding subscore. Under the pre-specified fixed sequence testing procedure, the significance level of 0.05 is used for assessment.|ANCOVA|||||||0.020
72616800|NCT00827242|144764528|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.11||0.233||95.0||||The p-value associates with LS Mean difference of changes from baseline to 12 weeks between treatment groups for IPSS nocturia question. Under the pre-specified fixed sequence testing procedure, the significance level of 0.05 is used for assessment.|ANCOVA|||||||0.233
72616801|NCT00827242|144764529|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.15||0.013||95.0||||The p-value associates with LS Mean difference of changes from baseline to 12 weeks between treatment groups for IPSS QoL Index. Under the pre-specified fixed sequence testing procedure, the significance level of 0.05 is used for assessment.|ANCOVA|||||||0.013
72616802|NCT00827242|144764530|SUPERIORITY_OR_OTHER|||||||0.021||95.0||||The p-value associates with difference between treatment groups for the 7 response categories.|Cochran-Mantel-Haenszel|Results were adjusted for baseline LUTS severity (moderate \[total IPSS \< 20\]; severe \[total IPSS \>= 20\]||||||0.021
72616803|NCT00827242|144764531|SUPERIORITY_OR_OTHER|||||||0.009||95.0||||The p-value associates with difference between treatment groups for the 7 response categories.|Cochran-Mantel-Haenszel|Results were adjusted for baseline LUTS severity (moderate \[total IPSS \< 20\]; severe \[total IPSS \>= 20\]||||||0.009
72616804|NCT00827242|144764532|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|0.49||0.146||95.0||||The p-value associates with LS Mean difference of changes from baseline to 1 week between treatment groups for IPSS. Under the pre-specified fixed sequence testing procedure, the significance level of 0.05 is used for assessment.|ANCOVA|||||||0.146
72622277|NCT04250207|144774535|SUPERIORITY|||||||0.7116|||||||Log Rank|||||||0.7116
72371610|NCT00669409|144253448|SUPERIORITY_OR_OTHER_LEGACY||Least Mean Square Difference|1.8|STANDARD_ERROR_OF_MEAN|7.99|||TWO_SIDED|95.0|-14.0|17.6||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||17.6|-14.0|
72616805|NCT00827242|144764533|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.8|STANDARD_ERROR_OF_MEAN|0.6||0.003||95.0||||The p-value associates with LS Mean difference of changes from baseline to 4 weeks between treatment groups for IPSS. Under the pre-specified fixed sequence testing procedure, the significance level of 0.05 is used for assessment.|ANCOVA|||||||0.003
72616806|NCT00827242|144764534|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.7|STANDARD_ERROR_OF_MEAN|1.12|<|0.001||95.0||||The p-value associates with LS Mean difference of changes from baseline to 12 weeks between treatment groups for IIEF-EF domain score. Under the pre-specified fixed sequence testing procedure, the significance level of 0.05 is used for assessment.|ANCOVA|||||||<0.001
72616807|NCT00827242|144764535|SUPERIORITY_OR_OTHER|||||||0.3||95.0||||The p-value associates with mean difference of changes from baseline to 12 weeks between treatment groups for Qmax. Under the pre-specified fixed sequence testing procedure, the significance level of 0.05 is used for assessment.|ranked ANOVA|||||||0.300
72616808|NCT00827242|144764538|SUPERIORITY_OR_OTHER|||||||0.5||95.0||||The p-value associates with mean difference of changes from baseline to 12 weeks between treatment groups for PVR volume. Under the pre-specified fixed sequence testing procedure, the significance level of 0.05 is used for assessment.|ranked ANOVA|||||||0.500
72616809|NCT05987540|144764568|SUPERIORITY|||||||0.8125|||||||Wilcoxon matched-pairs signed rank|||||||.8125
72616810|NCT05987540|144764571|SUPERIORITY||||||>|0.9999|||||||Wilconxon matched-pairs signed rank test|||||||>0.9999
72616811|NCT00471107|144764572|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||ANOVA|||Power analysis was based on WMS-III Word Lists performance. With an effect comparable to the effect on verbal fluency in an earlier study of left frontal TDCS in healthy subjects, it would require 10 subjects per group (30 total) for a significance level of 0.05 and 80% power.||||>0.05
72616812|NCT00888849|144764626|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.3|STANDARD_ERROR_OF_MEAN|7.69||0.7774|TWO_SIDED|95.0|-19.4|10.9||Adjusted for multiplicity via the Bonferroni-Holm method|ANOVA|||||10.9|-19.4|0.7774
72616813|NCT00888849|144764627|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.9|STANDARD_ERROR_OF_MEAN|0.8||0.0008|TWO_SIDED|95.0|1.4|4.5||Adjusted for multiplicity via Bonferroni-Holm procedure|ANOVA|||||4.5|1.4|0.0008
72616814|NCT00888849|144764628|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|0.21||0.7774|TWO_SIDED|95.0|-0.2|0.6||Adjusted for multiplicity via Bonferroni-Holm procedure|ANOVA|||||0.6|-0.2|0.7774
72616815|NCT02697422|144764639|SUPERIORITY|||||||0.05|TWO_SIDED|95.0|||||Regression, Linear|||||||0.05
72616816|NCT02697422|144764640|SUPERIORITY|||||||0.05|TWO_SIDED|95.0|||||Regression, Linear|||||||0.05
72616817|NCT02697422|144764641|SUPERIORITY|||||||0.05|TWO_SIDED|95.0|||||Regression, Linear|||||||0.05
72616818|NCT02697422|144764642|SUPERIORITY|||||||0.9|TWO_SIDED|95.0||||Smoker/tobacco use results were calculated using logistic regression.|Regression, Logistic|||Smoker/tobacco use results were calculated using logistic regression. A P value of .90 was found comparing smoking/tobacco use in intervention vs control participants. A difference was not reported between intervention and control because smoking/ tobacco use was a binary variable.||||0.90
72616819|NCT02697422|144764643|SUPERIORITY|||||||0.05|TWO_SIDED|95.0|||||Regression, Linear|||||||0.05
72616820|NCT02697422|144764644|SUPERIORITY|||||||0.05|TWO_SIDED|95.0|||||Regression, Linear|||||||0.05
72616821|NCT02697422|144764645|SUPERIORITY|||||||0.05|TWO_SIDED|95.0|||||Regression, Linear|||||||0.05
72616822|NCT02697422|144764646|SUPERIORITY|||||||0.05|TWO_SIDED|95.0|||||Regression, Linear|||||||0.05
72616823|NCT02697422|144764647|SUPERIORITY|||||||0.05|TWO_SIDED|95.0|||||Regression, Linear|||||||0.05
72616824|NCT02697422|144764648|SUPERIORITY|||||||0.05|TWO_SIDED|95.0|||||Regression, Linear|||||||0.05
72616825|NCT01659541|144764649|OTHER|Statistical analyses were performed using a repeated measures analysis of variance and Paired t test. A p value was calculated.|||||<|0.05|||||||ANOVA|Statistical analyses will be performed using a repeated measures analysis of variance and Paired t test.||Each patient was served as their own control (Pre-Implant); comparisons was made at various points in the study (Week #28, #40 and #52).||||<0.05
72616826|NCT01659541|144764650|OTHER|Statistical analyses were performed using a repeated measures analysis of variance and Paired t test. A p value was calculated.|||||<|0.05|||||||ANOVA|Statistical analyses will be performed using a repeated measures analysis of variance and Paired t test.||Each patient was served as their own control (Pre-Implant); comparisons were made at various points in the study (Week #28, #40 and #52).||||<0.05
72616827|NCT01659541|144764651|OTHER||||||<|0.05|||||||nonparametric analog (Freidman Test)|||The data prior to implantation (Pre-Implant)) were compared with data obtained after implantation (Week ##28, #40, #52) of the cough system using a nonparametric analog (Friedman Test) to the standard repeated measures analysis of variance. A p value was calculated. This alpha level was chosen as a correlation for inflated type I error rates because of multiple comparisons. Results are reported as means ± Standard Error.||||<0.05
72616828|NCT01659541|144764652|OTHER||||||<|0.05|||||||nonparametric analog (Freidman Test)|||The data prior to implantation (Pre-Implant) were compared with data obtained after implantation (Week #28, #40, #52) of the cough system using a nonparametric analog (Friedman Test) to the standard repeated measures analysis of variance. A p value was calculated. This alpha level was chosen as a correlation for inflated type I error rates because of multiple comparisons. Results are reported as means ± Standard Error.||||<0.05
72616829|NCT01659541|144764653|OTHER||||||<|0.05|||||||nonparametric analog (Freidman Test)|||The data prior to implantation (Pre-Implant) were compared with data obtained after implantation (Week #28 ,#40, #52) of the cough system using a nonparametric analog (Friedman Test) to the standard repeated measures analysis of variance. Paired t test. A p value was calculated. This alpha level was chosen as a correlation for inflated type I error rates because of multiple comparisons. Results are reported as means ± Standard Error.||||<0.05
72616830|NCT01659541|144764654|OTHER||||||<|0.05|||||||nonparametric analog (Freidman Test)|||The data prior to implantation (Pre-Implant) were compared with data obtained after implantation (Week #28, #40, #52) of the cough system using a nonparametric analog (Friedman Test) to the standard repeated measures analysis of variance. A p value was calculated. This alpha level was chosen as a correlation for inflated type I error rates because of multiple comparisons. Results are reported as means ± Standard Error.||||<0.05
72616831|NCT03055507|144764660|SUPERIORITY||Mean Difference (Final Values)|-0.9|||<|0.05|TWO_SIDED|96.0|-2.4|0.5|||t-test, 1 sided|||||0.5|-2.4|<0.05
72616832|NCT03296345|144764675|OTHER||Mean Difference (Final Values)|-15.0||||0.004|TWO_SIDED|95.0|-28.0|-2.3|||Wilcoxon (Mann-Whitney)|||||-2.3|-28|0.004
72616833|NCT03296345|144764676|OTHER|||||||0.38|||||||Wilcoxon (Mann-Whitney)|||||||0.38
72616834|NCT03296345|144764677|OTHER|||||||0.58|||||||Wilcoxon (Mann-Whitney)|||||||0.58
72616835|NCT03296345|144764679|OTHER|A Wilcoxon sign-rank, given non parametric data, was used to compare the intervention and historical control groups for statistical significance, while a student's t-test was used to estimate effect size||||||0.76|||||||Wilcoxon (Mann-Whitney)|||||||0.76
72616836|NCT02068599|144764682|SUPERIORITY||LSM difference from placebo|4.26||||0.1213|TWO_SIDED|95.0|-1.13|9.66||5% level of significance|mixed model for repeated measures|||LSM = least square mean||9.66|-1.13|0.1213
72616837|NCT02068599|144764682|SUPERIORITY||LSM difference from placebo|1.74||||0.5231|TWO_SIDED|95.0|-3.62|7.11||5% level of significance|mixed model for repeated measures|||LSM = least square mean||7.11|-3.62|0.5231
72616838|NCT02068599|144764683|SUPERIORITY||LSM difference from placebo|17.86||||0.1795|TWO_SIDED|95.0|-8.26|43.98||5% level of significance|mixed model for repeated measures|||LSM = least square mean||43.98|-8.26|0.1795
72616839|NCT02068599|144764683|SUPERIORITY||LSM difference from placebo|9.0||||0.4956|TWO_SIDED|95.0|-16.95|34.96||5% level of significance|mixed model for repeated measures|||LSM = least square mean||34.96|-16.95|0.4956
72616840|NCT02068599|144764684|SUPERIORITY||LSM difference from placebo|3.61||||0.1963|TWO_SIDED|95.0|-1.87|9.08||5% level of significance|mixed model for repeated measures|||||9.08|-1.87|0.1963
72616841|NCT02068599|144764684|SUPERIORITY||LSM difference from placebo|2.06||||0.4584|TWO_SIDED|95.0|-3.39|7.5||5% level of significance|mixed model for repeated measures|||||7.50|-3.39|0.4584
72616842|NCT02068599|144764685|SUPERIORITY||LSM difference from placebo|23.51||||0.642|TWO_SIDED|95.0|-75.83|122.84||5% level of significance|mixed model for repeated measures|||||122.84|-75.83|0.6420
72616843|NCT02068599|144764685|SUPERIORITY||LSM difference from placebo|-50.4||||0.3141|TWO_SIDED|95.0|-148.72|47.92||5% level of significance|mixed model for repeated measures|||||47.92|-148.72|0.3141
72616844|NCT02068599|144764686|SUPERIORITY||LSM difference from placebo|3.16||||0.6184|TWO_SIDED|95.0|-9.31|15.63||5% level of significance|mixed model for repeated measures|||||15.63|-9.31|0.6184
72616845|NCT02068599|144764686|SUPERIORITY||LSM difference from placebo|-3.48||||0.5775|TWO_SIDED|95.0|-15.78|8.81||5% level of significance|mixed model for repeated measures|||||8.81|-15.78|0.5775
72616846|NCT02068599|144764687|SUPERIORITY||Odds Ratio (OR)|0.62||||0.1011|TWO_SIDED|95.0|0.345|1.099||5% level of significance|mixed model for repeated measures|||\>=50% responder rate||1.099|0.345|0.1011
72616847|NCT02068599|144764687|SUPERIORITY||Odds Ratio (OR)|1.06||||0.84|TWO_SIDED|95.0|0.615|1.819||5% level of significance|mixed model for repeated measures|||\>=50% responder rate||1.819|0.615|0.8400
72616848|NCT02068599|144764687|SUPERIORITY||Odds Ratio (OR)|0.89||||0.6607|TWO_SIDED|95.0|0.531|1.494||5% level of significance|mixed model for repeated measures|||\>=30% responder rate||1.494|0.531|0.6607
72616849|NCT02068599|144764687|SUPERIORITY||Odds Ratio (OR)|0.87||||0.5777|TWO_SIDED|95.0|0.52|1.441||5% level of significance|mixed model for repeated measures|||\>=30% responder rate||1.441|0.520|0.5777
72616850|NCT02068599|144764688|SUPERIORITY||LSM difference from placebo|3.94||||0.4316|TWO_SIDED|95.0|-5.9|13.79||5% level of significance|mixed model for repeated measures|||||13.79|-5.90|0.4316
72616851|NCT02068599|144764688|SUPERIORITY||LSM difference from placebo|2.51||||0.6126|TWO_SIDED|95.0|-7.24|12.26||5% level of significance|mixed model for repeated measures|||||12.26|-7.24|0.6126
72616852|NCT02068599|144764689|SUPERIORITY||LSM difference from placebo|0.01||||0.9208|TWO_SIDED|95.0|-0.232|0.257||5% level of significance|mixed model for repeated measures|||Week 2||0.257|-0.232|0.9208
72616853|NCT02068599|144764689|SUPERIORITY||LSM difference from placebo|0.04||||0.7344|TWO_SIDED|95.0|-0.2|0.284||5% level of significance|mixed model for repeated measures|||Week 2||0.284|-0.200|0.7344
72616854|NCT02068599|144764689|SUPERIORITY||LSM difference from placebo|0.21||||0.1199|TWO_SIDED|95.0|-0.056|0.486||5% level of significance|mixed model for repeated measures|||Week 4||0.486|-0.056|0.1199
72616855|NCT02068599|144764689|SUPERIORITY||LSM difference from placebo|0.06||||0.6357|TWO_SIDED|95.0|-0.204|0.334||5% level of significance|mixed model for repeated measures|||Week 4||0.334|-0.204|0.6357
72616856|NCT02068599|144764690|SUPERIORITY||LSM difference from placebo|2.77||||0.2906|TWO_SIDED|95.0|-2.377|7.916||5% level of significance|mixed model for repeated measures|||Week 2||7.916|-2.377|0.2906
72616857|NCT02068599|144764690|SUPERIORITY||LSM difference from placebo|1.41||||0.5892|TWO_SIDED|95.0|-3.707|6.518||5% level of significance|mixed model for repeated measures|||Week 2||6.518|-3.707|0.5892
72616858|NCT02068599|144764690|SUPERIORITY||LSM difference from placebo|0.82||||0.7699|TWO_SIDED|95.0|-4.678|6.315||5% level of significance|mixed model for repeated measures|||Week 4||6.315|-4.678|0.7699
72616859|NCT02068599|144764690|SUPERIORITY||LSM difference from placebo|1.74||||0.532|TWO_SIDED|95.0|-3.721|7.193||5% level of significance|mixed model for repeated measures|||Week 4||7.193|-3.721|0.5320
72616860|NCT02068599|144764691|SUPERIORITY||Odds Ratio (OR)|0.85||||0.5358|TWO_SIDED|95.0|0.501|1.433||5% level of significance|generalized estimating equation (GEE)|||For the responder analyses, participants with missing values were deemed non-responders. Analysis performed using a generalized estimating equation (GEE) method where binary variable responder rate (Yes/No) was modeled through logit link function, with treatment, center, week, and treatment\*week as explanatory factors. The unstructured working correlation structure was applied.||1.433|0.501|0.5358
72622278|NCT04250207|144774536|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.||||||0.0915|||||||Chi-square or Fisher exact|||Week 3||||0.0915
72622279|NCT04250207|144774536|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.||||||0.3282|||||||Chi-square or Fisher exact|||Week 3||||0.3282
72616861|NCT02068599|144764691|SUPERIORITY||Odds Ratio (OR)|1.45||||0.1532|TWO_SIDED|95.0|0.87|2.423||5% level of significance|generalized estimating equation (GEE)|||For the responder analyses, participants with missing values were deemed non-responders. Analysis performed using a generalized estimating equation (GEE) method where binary variable responder rate (Yes/No) was modeled through logit link function, with treatment, center, week, and treatment\*week as explanatory factors. The unstructured working correlation structure was applied.||2.423|0.870|0.1532
72616862|NCT01666314|144764772|SUPERIORITY_OR_OTHER|||||||0.1078|TWO_SIDED||||||Fisher Exact|||||||0.1078
72616863|NCT01666314|144764773|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.145||||0.0355|TWO_SIDED|95.0|0.9895|18.7606|||Fisher Exact||Odds ratio \>1 favors orteronel.|||18.7606|0.9895|0.0355
72622280|NCT04250207|144774536|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.||||||0.0648|||||||Chi-square or Fisher exact|||Week 5||||0.0648
72622281|NCT04250207|144774536|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.||||||0.031|||||||Chi-square or Fisher exact|||Week 5||||0.0310
72622282|NCT04250207|144774536|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.||||||0.0187|||||||Chi-square or Fisher exact|||Week 7||||0.0187
72622283|NCT04250207|144774536|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.||||||0.0036|||||||Chi-square or Fisher exact|||Week 7||||0.0036
72622284|NCT04250207|144774536|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.||||||0.0687|||||||Chi-square or Fisher exact|||Week 9||||0.0687
72622285|NCT04250207|144774536|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.||||||0.0016|||||||Chi-square or Fisher exact|||Week 9||||0.0016
72622286|NCT04250207|144774536|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.||||||0.0218|||||||Chi-square or Fisher exact|||Week 12||||0.0218
72622287|NCT04250207|144774536|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.||||||0.0013|||||||Chi-square or Fisher exact|||Week 12||||0.0013
72622288|NCT04250207|144774536|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.||||||0.0348|||||||Chi-square or Fisher exact|||Week 16||||0.0348
72432384|NCT02696785|144377177|SUPERIORITY||LSMean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.32||0.027|TWO_SIDED|95.0|-1.3|-0.1|||Mixed Models Analysis|||||-0.1|-1.3|0.027
72622289|NCT04250207|144774536|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.||||||0.1028|||||||Chi-square or Fisher exact|||Week 16||||0.1028
72622290|NCT04250207|144774536|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.||||||0.8677|||||||Chi-square or Fisher exact|||Week 20||||0.8677
72622291|NCT04250207|144774536|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.||||||0.4401|||||||Chi-square or Fisher exact|||Week 20||||0.4401
72622292|NCT04250207|144774536|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.||||||0.5926|||||||Chi-square or Fisher exact|||Week 24||||0.5926
72622293|NCT04250207|144774536|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.||||||0.0732|||||||Chi-square or Fisher exact|||Week 24||||0.0732
72622294|NCT04250207|144774536|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.||||||0.2497|||||||Chi-square or Fisher exact|||Week 38||||0.2497
72622295|NCT04250207|144774536|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.||||||0.2453|||||||Chi-square or Fisher exact|||Week 38||||0.2453
72622296|NCT04250207|144774536|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.|||||>|0.9999|||||||Chi-square or Fisher exact|||Week 52||||> 0.9999
72616864|NCT03197935|144764825|SUPERIORITY||Absolute difference in pCR rate|16.5||||0.0044|TWO_SIDED|95.0|5.91|27.1||(one-sided)|Cochran-Mantel-Haenszel|||Stratified analysis. Strata are: tumor PD-L1 status (IC0 vs. IC1/2/3) and clinical stage at presentation (Stage II vs. III).||27.10|5.91|0.0044
72616865|NCT03197935|144764826|SUPERIORITY||Difference in pCR|19.5||||0.0206|TWO_SIDED|95.0|4.17|34.83||(one-sided)|Cochran-Mantel-Haenszel|||Stratified analysis. Strata are: AJCC stage at diagnosis (II vs. III).||34.83|4.17|0.0206
72616866|NCT03197935|144764827|OTHER|This study was not designed nor formally powered to demonstrate statistically significant improvements in the secondary efficacy endpoint of EFS. The analyses of this secondary endpoint is descriptive in nature.|Hazard Ratio (HR)|0.76|||||TWO_SIDED|95.0|0.47|1.21|||Stratified log-rank test|||"Stratified analysis. Strata are:~Tumor PD-L1 status (IC0 vs IC1/2/3) and AJCC stage at diagnosis (II vs. III)."||1.21|0.47|
72616867|NCT03197935|144764828|OTHER|This study was not designed nor formally powered to demonstrate statistically significant improvements in the secondary efficacy endpoint of EFS. The analyses of this secondary endpoint is descriptive in nature.|Hazard Ratio (HR)|0.55|||||TWO_SIDED|95.0|0.26|1.18|||Stratified log-rank test|||Stratified analysis. Strata are: AJCC stage at diagnosis (II vs. III).||1.18|0.26|
72616868|NCT03197935|144764829|OTHER|This study was not designed nor formally powered to demonstrate statistically significant improvements in the secondary efficacy endpoint of DFS. The analyses of this secondary endpoint are descriptive in nature.|Hazard Ratio (HR)|0.76|||||TWO_SIDED|95.0|0.44|1.3|||Stratified log-rank test|||Stratified analysis. Strata are: Tumor PD-L1 status (IC0 vs IC1/2/3) and AJCC stage at diagnosis (II vs. III).||1.30|0.44|
72616869|NCT03197935|144764830|OTHER|This study was not designed nor formally powered to demonstrate statistically significant improvements in the secondary efficacy endpoint of DFS. The analyses of this secondary endpoint are descriptive in nature.|Hazard Ratio (HR)|0.57|||||TWO_SIDED|95.0|0.23|1.43|||Stratified log-rank test|||Stratified analysis. Strata are: AJCC stage at diagnosis (II vs. III).||1.43|0.23|
72616870|NCT03197935|144764831|OTHER|This study was not designed nor formally powered to demonstrate statistically significant improvements in the secondary efficacy endpoints of OS. The analyses of this secondary endpoint are descriptive in nature.|Hazard Ratio (HR)|0.56|||||TWO_SIDED|95.0|0.3|1.04|||Stratified log-rank test|||"Stratified analysis. Strata are:~Tumor PD-L1 status (IC0 vs IC1/2/3) and AJCC stage at diagnosis (II vs. III)."||1.04|0.30|
72616871|NCT03197935|144764832|OTHER|This study was not designed nor formally powered to demonstrate statistically significant improvements in the secondary efficacy endpoints of EFS, DFS and OS. The analyses of this secondary endpoint are descriptive in nature.|Hazard Ratio (HR)|0.71|||||TWO_SIDED|95.0|0.26|1.91|||Stratified log-rank test|||Stratified analysis. Strata are: AJCC stage at diagnosis (II vs. III).||1.91|0.26|
72616872|NCT01160744|144764864|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.75||||0.1318|TWO_SIDED|90.0|0.55|1.03|||Log Rank|||||1.03|0.55|0.1318
72616873|NCT01160744|144764864|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.88||||0.5215|TWO_SIDED|90.0|0.64|1.22|||Log Rank|||||1.22|0.64|0.5215
72616874|NCT01160744|144764865|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.58||||0.1797|TWO_SIDED|90.0|0.9|2.78|||Chi-squared|||||2.78|0.90|0.1797
72616875|NCT01160744|144764865|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.66||||0.007|TWO_SIDED|90.0|1.45|4.86|||Chi-squared|||||4.86|1.45|0.0070
72616876|NCT01160744|144764866|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.03||||0.8916|TWO_SIDED|90.0|0.74|1.42|||Log Rank|||||1.42|0.74|0.8916
72616877|NCT01160744|144764866|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.93||||0.6847|TWO_SIDED|90.0|0.68|1.27|||Log Rank|||||1.27|0.68|0.6847
72616878|NCT01160744|144764869|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.48||||0.0316|TWO_SIDED|90.0|1.22|5.02|||Chi-squared|||||5.02|1.22|0.0316
72371611|NCT00669409|144253448|SUPERIORITY_OR_OTHER_LEGACY||Least Mean Square Difference|-3.6|STANDARD_ERROR_OF_MEAN|7.88|||TWO_SIDED|95.0|-19.2|12.0||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||12.0|-19.2|
72616879|NCT01160744|144764869|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.37||||0.3962|TWO_SIDED|90.0|0.74|2.52|||Chi-squared|||||2.52|0.74|0.3962
72616880|NCT01160744|144764870|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1571|TWO_SIDED||||||t-test, 2 sided|||||||0.1571
72616881|NCT01160744|144764870|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1597|TWO_SIDED||||||t-test, 2 sided|||||||0.1597
72616882|NCT04676646|144764880|SUPERIORITY||Odds Ratio (OR)|4.45|||<|0.001|TWO_SIDED|95.0|2.89|6.86|||GEE model||An odds ratio greater than 1 indicated increased odds of response on SZC compared to placebo.|||6.86|2.89|<0.001
72616883|NCT04676646|144764881|SUPERIORITY||Odds Ratio (OR)|4.58|||<|0.001|TWO_SIDED|95.0|2.78|7.55|||GEE model||An odds ratio \>1 indicated increased odds of response on SZC compared to placebo.|||7.55|2.78|<0.001
72616884|NCT04676646|144764882|SUPERIORITY||Odds Ratio (OR)|4.33|||<|0.001|TWO_SIDED|95.0|2.5|7.52|||GEE model||An odds ratio greater than 1 indicated increased odds of response on SZC compared to placebo.|||7.52|2.50|<0.001
72616885|NCT04676646|144764883|SUPERIORITY||Hazard Ratio (HR)|0.51|||<|0.001||95.0|0.37|0.71|||Regression, Cox||A hazard ratio less than 1 favors SZC to be associated with a longer time to first hyperkalaemia episode than placebo.|||0.71|0.37|<0.001
72616886|NCT04676646|144764884|SUPERIORITY||Hazard Ratio (HR)|0.37||||0.006|TWO_SIDED|95.0|0.17|0.73|||Regression, Cox||A hazard ratio less than 1 favored SZC to be associated with a longer time to first instance of a decrease of spironolactone dose due to hyperkalaemia than placebo.|||0.73|0.17|0.006
72616887|NCT04676646|144764885|SUPERIORITY||Least-squares Mean Difference|-1.01|STANDARD_ERROR_OF_MEAN|2.84||0.724|TWO_SIDED|95.0|-6.64|4.63|||t-test, 2 sided||A least-squares mean difference greater than 0 favors SZC compared to placebo.|||4.63|-6.64|0.724
72616888|NCT02993302|144764900|OTHER|||||||0.48|||||||Wilcoxon (Mann-Whitney)|||||||0.48
72616889|NCT02993302|144764901|OTHER|||||||0.47|||||||Wilcoxon (Mann-Whitney)|||||||0.47
72616890|NCT02993302|144764902|OTHER|||||||0.53|||||||Wilcoxon (Mann-Whitney)|||||||0.53
72616891|NCT01755637|144764906|NON_INFERIORITY_OR_EQUIVALENCE|The bioequivalence between the two products was concluded if the 90% CIs (based on log transformed data and anti-logged) for the ratio of the geometric means lie completely within the range 80%-125%|Geometric mean Ratio of treatments|114.37|||||TWO_SIDED|90.0|100.49|130.16|||||Geometric mean ratio of experimental and reference product was determined by exponentiating least-squares means of log-transformed value.|The value was log-transformed and a linear mixed effects model was applied to this value, as the dependent variable, treatment, and period as fixed effects and participants as random effect.||130.16|100.49|
72616892|NCT01755637|144764907|NON_INFERIORITY_OR_EQUIVALENCE|The bioequivalence between the two products was concluded if the 90% CIs (based on log transformed data and anti-logged) for the ratio of the geometric means lie completely within the range 80%-125%|Geometric mean ratio of treatments|107.41|||||TWO_SIDED|90.0|69.03|167.13|||||Geometric mean ratio of experimental and reference product was determined by exponentiating least-squares means of log-transformed value.|The value was log-transformed and a linear mixed effects model was applied to this value, as the dependent variable, treatment, and period as fixed effects and participants as random effect.||167.13|69.03|
72616893|NCT01755637|144764908|NON_INFERIORITY_OR_EQUIVALENCE|The bioequivalence between the two products was concluded if the 90% CIs (based on log transformed data and anti-logged) for the ratio of the geometric means lie completely within the range of 70% -143%.|Geometric mean ratio of treatments|111.28|||||TWO_SIDED|90.0|94.76|130.68|||||Geometric mean ratio of experimental and reference product was determined by exponentiating least-squares means of log-transformed value.|The value was log-transformed and a linear mixed effects model was applied to this value, as the dependent variable, treatment, and period as fixed effects and participants as random effect.||130.68|94.76|
72616894|NCT01755637|144764909|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0167||||0.0011||95.0|||||Wilcoxon signed rank test|The values were not adjusted for this non-parametric analysis.|The median difference was calculated as = (Experimental-Reference)|The null hypothesis considered that there is no median within-subject difference between two treatment groups.||||0.0011
72616895|NCT01755637|144764910|NON_INFERIORITY_OR_EQUIVALENCE|The bioequivalence between the two products was concluded if the 90% CIs (based on log transformed data and anti-logged) for the ratio of the geometric means lie completely within the range 80%-125%|Geometric mean ratio of treatments|112.05|||||TWO_SIDED|90.0|103.65|121.12|||||Geometric mean ratio of experimental and reference product was determined by exponentiating least-squares means of log-transformed value.|The value was log-transformed and a linear mixed effects model was applied to this value, as the dependent variable, treatment, and period as fixed effects and participants as random effect.||121.12|103.65|
72616896|NCT01755637|144764911|NON_INFERIORITY_OR_EQUIVALENCE|The bioequivalence between the two products was concluded if the 90% CIs (based on log transformed data and anti-logged) for the ratio of the geometric means lie completely within the range 80%-125%|Geometric mean ratio of treatments|113.1|||||TWO_SIDED|90.0|103.4|123.71|||||Geometric mean ratio of experimental and reference product was determined by exponentiating least-squares means of log-transformed value.|The value was log-transformed and a linear mixed effects model was applied to this value, as the dependent variable, treatment, and period as fixed effects and participants as random effect.||123.71|103.40|
72616897|NCT01755637|144764912|NON_INFERIORITY_OR_EQUIVALENCE|The bioequivalence between the two products was concluded if the 90% CIs (based on log transformed data and anti-logged) for the ratio of the geometric means lie completely within the range of 70% -143%.|Geometric mean ratio of treatments|114.33|||||TWO_SIDED|90.0|102.99|126.93|||||Geometric mean ratio of experimental and reference product was determined by exponentiating least-squares means of log-transformed value.|The value was log-transformed and a linear mixed effects model was applied to this value, as the dependent variable, treatment, and period as fixed effects and participants as random effect.||126.93|102.99|
72616898|NCT03338023|144764934|NON_INFERIORITY|Noninferiority of LY2963016 to Lantus® was demonstrated at the 0.4% noninferiority margin and over 80 percent power.|Mean Difference (Net)|-0.12|||||TWO_SIDED|95.0|-0.32|0.08||||||||0.08|-0.32|
72616899|NCT03338023|144764935|NON_INFERIORITY|Noninferiority of Lantus® to LY2963016 was demonstrated at the 0.4% noninferiority margin.|Mean Difference (Net)|-0.12|||||TWO_SIDED|95.0|-0.32|0.08||||||||0.08|-0.32|
72616900|NCT03338023|144764936|SUPERIORITY||Mean Difference (Net)|-6.8||||0.191|TWO_SIDED|95.0|-17.0|3.4|||Mixed Models Analysis|||Before Morning Meal Glucose||3.4|-17.0|0.191
72616901|NCT03338023|144764936|SUPERIORITY||Mean Difference (Net)|-7.8||||0.25|TWO_SIDED|95.0|-21.2|5.5|||Mixed Models Analysis|||2 Hours After Morning Meal Glucose||5.5|-21.2|0.250
72616902|NCT03338023|144764936|SUPERIORITY||Mean Difference (Net)|-13.1||||0.028|TWO_SIDED|95.0|-24.7|-1.5|||Mixed Models Analysis|||Before Mid-Day Meal Glucose||-1.5|-24.7|0.028
72616903|NCT03338023|144764936|SUPERIORITY||Mean Difference (Net)|-3.6||||0.599|TWO_SIDED|95.0|-16.8|9.7|||Mixed Models Analysis|||2 Hours After Mid-Day Meal Glucose||9.7|-16.8|0.599
72616904|NCT03338023|144764936|SUPERIORITY||Mean Difference (Net)|-11.0||||0.109|TWO_SIDED|95.0|-24.4|2.5|||Mixed Models Analysis|||Before Evening Meal Glucose||2.5|-24.4|0.109
72616905|NCT03338023|144764936|SUPERIORITY||Mean Difference (Net)|-5.4||||0.452|TWO_SIDED|95.0|-19.4|8.6|||Mixed Models Analysis|||Bedtime Glucose||8.6|-19.4|0.452
72616906|NCT03338023|144764936|SUPERIORITY||Mean Difference (Net)|-7.4||||0.18|TWO_SIDED|95.0|-18.3|3.5|||Mixed Models Analysis|||0300 Am Glucose||3.5|-18.3|0.180
72616907|NCT03338023|144764937|SUPERIORITY|||||||0.787|||||||Fisher Exact|||||||0.787
72616908|NCT03338023|144764938|SUPERIORITY|||||||0.201|||||||Fisher Exact|||||||0.201
72616909|NCT03338023|144764939|SUPERIORITY||Mean Difference (Net)|-0.3||||0.885|TWO_SIDED|95.0|-0.4|3.4|||Mixed Models Analysis|||||3.4|-0.4|0.885
72616910|NCT03338023|144764940|SUPERIORITY||Mean Difference (Net)|-3.5||||0.328|TWO_SIDED|95.0|-10.6|3.6|||Mixed Models Analysis|||Morning Pre-meal Standard Deviation||3.6|-10.6|0.328
72616911|NCT03338023|144764940|SUPERIORITY||Mean Difference (Net)|-1.7||||0.467|TWO_SIDED|95.0|-6.5|3.0|||Mixed Models Analysis|||Daily Mean Standard Deviation||3.0|-6.5|0.467
72616912|NCT03338023|144764941|SUPERIORITY||Mean Difference (Net)|-0.8||||0.09|TWO_SIDED|95.0|-1.7|0.1|||Mixed Models Analysis|||||0.1|-1.7|0.090
72616913|NCT03338023|144764942|SUPERIORITY||Mean Difference (Net)|-1.2||||0.089|TWO_SIDED|95.0|-2.6|0.2|||Mixed Models Analysis|||||0.2|-2.6|0.089
72616914|NCT03338023|144764943|SUPERIORITY||Mean Difference (Net)|-0.1||||0.77|TWO_SIDED|95.0|-0.7|0.5|||Mixed Models Analysis|||||0.5|-0.7|0.770
72616915|NCT03338023|144764944|SUPERIORITY||Mean Difference (Net)|-0.3||||0.879|TWO_SIDED|95.0|-3.9|3.3|||ANCOVA|||ITSQ Inconvenience of Regimen Transformed Score||3.3|-3.9|0.879
72616916|NCT03338023|144764944|SUPERIORITY||Mean Difference (Net)|-0.7||||0.788|TWO_SIDED|95.0|-5.9|4.5|||ANCOVA|||ITSQ Lifestyle Flexibility Transformed Score||4.5|-5.9|0.788
72616917|NCT03338023|144764944|SUPERIORITY||Mean Difference (Net)|-0.6||||0.775|TWO_SIDED|95.0|-4.5|3.3|||ANCOVA|||ITSQ Hypoglycemic Control Transformed Score||3.3|-4.5|0.775
72616918|NCT03338023|144764944|SUPERIORITY||Mean Difference (Net)|1.0||||0.681|TWO_SIDED|95.0|-3.6|5.6|||ANCOVA|||ITSQ Glycemic Control Transformed Score||5.6|-3.6|0.681
72616919|NCT03338023|144764944|SUPERIORITY||Mean Difference (Net)|0.4||||0.819|TWO_SIDED|95.0|-3.1|3.9|||ANCOVA|||ITSQ Insulin Delivery Device Satisfaction Transformed Score||3.9|-3.1|0.819
72616920|NCT03338023|144764944|SUPERIORITY||Mean Difference (Net)|-0.8||||0.605|TWO_SIDED|95.0|-3.9|2.3|||ANCOVA|||ITSQ Total Transformed Score||2.3|-3.9|0.605
72616921|NCT05061706|144764973|SUPERIORITY||Least Squares Mean Difference|-4.5|STANDARD_ERROR_OF_MEAN|0.77|<|0.0001|TWO_SIDED|95.0|-6.03|-3.02|||Mixed Effects Model for Repeated Measure|||||-3.02|-6.03|<0.0001
72616922|NCT05061706|144764974|SUPERIORITY||Least Squares Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001|TWO_SIDED|95.0|-0.72|-0.33|||Mixed Effects Model for Repeated Measure|||||-0.33|-0.72|<0.0001
72616923|NCT01222351|144765027|EQUIVALENCE|The null hypothesis was that there is no difference in the rate of cognitive decline between participants with and without amyloid.|Slope|-0.034||||0.02|TWO_SIDED||||||latent growth curve model|Latent growth curve models tested cognitive decline rate by amyloid status.|B weights were the estimates for the association between Aβ and cognitive change.|||||0.02
72616924|NCT02945046|144765035|OTHER||LS mean difference|-0.1|STANDARD_ERROR_OF_MEAN|1.3||0.9093|TWO_SIDED|95.0|-2.72|2.42||Threshold for significance at 0.05 level.|ANCOVA|||||2.42|-2.72|0.9093
72616925|NCT02945046|144765035|OTHER||LS mean difference|-1.9|STANDARD_ERROR_OF_MEAN|1.29||0.1345|TWO_SIDED|95.0|-4.49|0.61||Threshold for significance at 0.05 level.|ANCOVA|||||0.61|-4.49|0.1345
72616926|NCT02114684|144765090|SUPERIORITY|||||||0.46|||||||Fisher Exact|||comparison of culture negative results at week 8||||0.46
72616927|NCT02114684|144765090|SUPERIORITY|||||||0.43|||||||Fisher Exact|||comparison of culture negative results at month 6||||0.43
72616928|NCT02114684|144765091|SUPERIORITY|||||||0.018|||||||Gehan-Breslow-Wilcoxon test|||||||0.018
72616929|NCT02114684|144765092|SUPERIORITY|||||||0.011|||||||Fisher Exact|||||||0.011
72616930|NCT02114684|144765093|SUPERIORITY|||||||0.01||||||There are significantly more adverse events in the active arm|Mantel Haenszel|||Comparison of the number of adverse events in the two arms, controlling for HIV status||||0.01
72616931|NCT02114684|144765093|SUPERIORITY|||||||0.45|||||||Mantel Haenszel|||Comparison of the 8-week culture conversion rates in the two arms, controlling for HIV status||||0.45
72616932|NCT02114684|144765094|SUPERIORITY|||||||0.15|||||||Fisher Exact|||||||0.15
72616933|NCT00990769|144765095|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.9|STANDARD_DEVIATION|5.0|>|0.05|TWO_SIDED|95.0|||||t-test, 2 sided|||Sample size calculation concluded that 20 patients in each group would have 80% power to detect a mean difference of 4 ± 4 with alpha equal to 0.05, as would be determined by a two-sample T test.||||>0.05
72616934|NCT04625972|144765098|SUPERIORITY||Relative Risk Reduction|33.31||||0.212|TWO_SIDED|95.0|-25.92|64.68|||Poisson regression||Primary Analysis Estimates are based on Poisson regression with robust variance. The model includes covariate for treatment and the log of follow-up time as an offset. Estimated RRR greater than 0% provides evidence in favor of AZD7442.|||64.68|-25.92|0.212
72616935|NCT04625972|144765098|SUPERIORITY||Relative Risk Reduction|43.28||||0.044|TWO_SIDED|95.0|1.4|67.37|||Poisson regression||Final Analysis Estimates are based on Poisson regression with robust variance. The model includes covariate for treatment and the log of follow-up time as an offset. Estimated RRR greater than 0% provides evidence in favor of AZD7442.|||67.37|1.40|0.044
72616936|NCT04625972|144765100|SUPERIORITY||Relative Risk Reduction|100.0||||0.664|ONE_SIDED|97.5|-1836.98||||Poisson regression||||||-1836.98|0.664
72616937|NCT04625972|144765101|SUPERIORITY||Relative Risk Reduction|13.9||||0.163|TWO_SIDED|95.0|-6.23|30.21|||Poisson regression|||||30.21|-6.23|0.163
72616938|NCT04625972|144765103|SUPERIORITY||Relative Risk Reduction|25.75||||0.744|TWO_SIDED|95.0|-343.53|87.57|||Poisson regression|||||87.57|-343.53|0.744
72616939|NCT02641353|144765106|OTHER||Geometric Mean Ratio|84.9|||||TWO_SIDED|90.0|77.3|93.2|||||Ratio of adjusted geometric means (Treatment B / Treatment A) expressed as a percentage.|To assess the bioavailability between the apremilast oral suspension and tablet formulation an analysis of variance (ANOVA) model, with treatment, sequence, and period as fixed effects and subject nested within sequence as a random effect, was performed on the natural log-transformed Cmax.||93.2|77.3|
72616940|NCT02641353|144765106|OTHER||Geometric Mean Ratio|78.2|||||TWO_SIDED|90.0|71.2|86.0|||||Ratio of adjusted geometric means (Treatment C / Treatment B) expressed as a percentage.|To assess the effect of food on the PK of apremilast oral suspension formulation, an ANOVA model, with treatment, sequence, and period as fixed effects and subject nested within sequence as a random effect, was performed on the natural log-transformed Cmax.||86.0|71.2|
72616941|NCT02641353|144765107|OTHER||Geometric Mean Ratio|87.6|||||TWO_SIDED|90.0|83.0|92.5|||||Ratio of adjusted geometric means (Treatment B / Treatment A) expressed as a percentage.|To assess the bioavailability between the apremilast oral suspension and tablet formulation an ANOVA model, with treatment, sequence, and period as fixed effects and subject nested within sequence as a random effect, was performed on the natural log-transformed AUC0-t.||92.5|83.0|
72616942|NCT02641353|144765107|OTHER||Geometric Mean Ratio|115.3|||||TWO_SIDED|90.0|109.2|121.7|||||Ratio of adjusted geometric means (Treatment C / Treatment B) expressed as a percentage.|To assess the effect of food on the PK of apremilast oral suspension formulation, an ANOVA model, with treatment, sequence, and period as fixed effects and subject nested within sequence as a random effect, was performed on the natural log-transformed AUC0-t.||121.7|109.2|
72616943|NCT02641353|144765108|OTHER||Geometric Mean Ratio|87.8|||||TWO_SIDED|90.0|83.2|92.6|||||Ratio of adjusted geometric means (Treatment B / Treatment A) expressed as a percentage.|To assess the bioavailability between the apremilast oral suspension and tablet formulation an ANOVA model, with treatment, sequence, and period as fixed effects and subject nested within sequence as a random effect, was performed on the natural log-transformed AUC0-∞.||92.6|83.2|
72616944|NCT02641353|144765108|OTHER||Geometric Mean Ratio|115.0|||||TWO_SIDED|90.0|109.0|121.7|||||Ratio of adjusted geometric means (Treatment C / Treatment B) expressed as a percentage.|To assess the effect of food on the PK of apremilast oral suspension formulation, an ANOVA model, with treatment, sequence, and period as fixed effects and subject nested within sequence as a random effect, was performed on the natural log-transformed AUC0-∞.||121.7|109.0|
72616945|NCT02641353|144765109|OTHER||Median Difference|0.25||||0.1508|TWO_SIDED|90.0|0.0|0.5|||Wilcoxon signed-rank test||Median difference (Treatment B - Treatment A) calculated from the Hodges-Lehmann estimate|Tmax was analyzed by nonparametric methods. The median difference and 90% confidence interval (CI) of the median difference were calculated from the Hodges-Lehrmann estimate.||0.50|0.00|0.1508
72616946|NCT02641353|144765109|OTHER||Median Difference|2.25|||<|0.0001|TWO_SIDED|90.0|1.27|3.25|||Wilcoxon signed-rank test||Median difference (Treatment C - Treatment B) calculated from the Hodges-Lehmann estimate|Tmax was analyzed by nonparametric methods. The median difference and 90% CI of the median difference were calculated from the Hodges-Lehrmann estimate.||3.25|1.27|<0.0001
72616947|NCT03259308|144765116|SUPERIORITY|||||||0.027|||||||Cochran-Mantel-Haenszel|P-value was based on Cochran-Mantel-Haenszel chi-square test stratified by actual status of prior anti-TNF treatment and glucocorticoid at baseline.||||||0.027
72616948|NCT03259308|144765116|SUPERIORITY|||||||0.014|||||||Cochran-Mantel-Haenszel|P-value was based on Cochran-Mantel-Haenszel chi-square test stratified by actual status of prior anti-TNF treatment and glucocorticoid at baseline.||||||0.014
72616949|NCT03259308|144765117|SUPERIORITY|||||||0.001|||||||Cochran-Mantel-Haenszel|P-value was based on Cochran-Mantel-Haenszel chi-square test stratified by actual status of prior anti-TNF treatment and glucocorticoid at baseline.||||||0.001
72616950|NCT03259308|144765117|SUPERIORITY|||||||0.003|||||||Cochran-Mantel-Haenszel|P-value was based on Cochran-Mantel-Haenszel chi-square test stratified by actual status of prior anti-TNF treatment and glucocorticoid at baseline.||||||0.003
72616951|NCT03259308|144765118|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|P-value was based on Cochran-Mantel-Haenszel chi-square test stratified by actual status of prior anti-TNF treatment and glucocorticoid at baseline.||||||<0.001
72616952|NCT03259308|144765118|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|P-value was based on Cochran-Mantel-Haenszel chi-square test stratified by actual status of prior anti-TNF treatment and glucocorticoid at baseline.||||||<0.001
72616953|NCT03259308|144765119|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|P-value was based on Cochran-Mantel-Haenszel chi-square test stratified by actual status of prior anti-TNF treatment and glucocorticoid at baseline.||||||<0.001
72616954|NCT03259308|144765119|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|P-value was based on Cochran-Mantel-Haenszel chi-square test stratified by actual status of prior anti-TNF treatment and glucocorticoid at baseline.||||||<0.001
72616955|NCT03259308|144765120|SUPERIORITY|||||||0.002|||||||Cochran-Mantel-Haenszel|P-value was based on Cochran-Mantel-Haenszel chi-square test stratified by actual status of prior anti-TNF treatment and glucocorticoid at baseline.||||||0.002
72616956|NCT03259308|144765120|SUPERIORITY|||||||0.017|||||||Cochran-Mantel-Haenszel|P-value was based on Cochran-Mantel-Haenszel chi-square test stratified by actual status of prior anti-TNF treatment and glucocorticoid at baseline.||||||0.017
72616957|NCT00694122|144765140|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|277.9|STANDARD_ERROR_OF_MEAN|164.9|<|0.05|TWO_SIDED|95.0|-75.9|631.6|||t-test, 2 sided|No adjustments were made. T-test type: Paired samples t-test (df=14) was performed using 15 within subject differences.|The comparative measures was defined as (mean AUC of glargine (Lantus)) minus (mean AUC of NPH).|||631.6|-75.9|<0.05
72616958|NCT00694122|144765141|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
72616959|NCT00694122|144765145|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
72616960|NCT00809146|144765152|NON_INFERIORITY_OR_EQUIVALENCE|Assay sensitivity established by extensive review of lorazepam efficacy data. Noninferiority margin of 10% established by both clinical and statistical reasoning.|Risk Difference (RD)|0.1|||<|0.001|TWO_SIDED|95.0|0.04|0.16|||one-sided z statistic|||The null hypothesis of inferiority was tested with a one-sided z statistic. Sample size was estimated assuming independent proportions, 2 interim analyses, 70% control event rate; 90% power; a noninferiority margin of 10%; and a 1-sided test with type I error probability of 0.025. A sample size of 890 (445 per treatment group) was inflated by 15% (1024 subjects) to account for inadvertent repeated enrollment of the same subjects. Repeated enrollments of the same subject were not analyzed.||0.16|0.04|<0.001
72616961|NCT00809146|144765153|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.98|||||TWO_SIDED|95.0|0.7|1.34||||||||1.34|0.70|
72616962|NCT00809146|144765154|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.88|||||TWO_SIDED|95.0|0.79|0.98||||||||0.98|0.79|
72616963|NCT00809146|144765155|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.79|||||TWO_SIDED|95.0|0.65|0.95||||||||0.95|0.65|
72616964|NCT00809146|144765156|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.08|||||TWO_SIDED|95.0|0.74|1.56||||||All participants were included in this analysis of rate of recurrence because this is the most clinically relevant denominator, although, by definition, only participants who stopped could have recurrent seizures.||1.56|0.74|
72616965|NCT00809146|144765157|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.92|||||TWO_SIDED|95.0|0.42|1.98||||||||1.98|0.42|
72616966|NCT00809146|144765158|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.99|||||TWO_SIDED|95.0|0.3|10.7||||||||10.70|0.30|
72616967|NCT00809146|144765160|SUPERIORITY_OR_OTHER|||||||0.09||95.0|||||t-test, 2 sided|||||||0.09
72616968|NCT00809146|144765161|SUPERIORITY_OR_OTHER|||||||0.11||95.0|||||t-test, 2 sided|||||||0.11
72616969|NCT01245062|144765180|SUPERIORITY||Hazard Ratio (HR)|0.44|||<|0.0001|TWO_SIDED|95.0|0.31|0.64||P-value from a stratified log-rank test was adjusted for prior chemotherapy for advanced or metastatic disease and Baseline lactate dehydrogenase.|Log Rank||Investigator-Assessed PFS. HR \<1 indicates a lower risk with Trametinib compared with CT. HR from a stratified log-rank test was adjusted for prior chemotherapy for advanced or metastatic disease and Baseline lactate dehydrogenase.|||0.64|0.31|<0.0001
72616970|NCT01245062|144765180|SUPERIORITY||Hazard Ratio (HR)|0.41|||<|0.0001|TWO_SIDED|95.0|0.29|0.6||P-value from a stratified log-rank test was adjusted for prior chemotherapy for advanced or metastatic disease and Baseline lactate dehydrogenase.|Log Rank||Independent Review PFS. HR \<1 indicates a lower risk with Trametinib compared with CT. HR from a stratified log-rank test was adjusted for prior chemotherapy for advanced or metastatic disease and Baseline lactate dehydrogenase.|||0.60|0.29|<0.0001
72616971|NCT06025695|144765197|NON_INFERIORITY|Non-inferiority (NI) was to be demonstrated if the lower limit (LL) of the two-sided asymptotic standardized 95% confidence interval (CI) for the difference in seroconversion rate between the HRV PCV-free group and HRV group is greater than or equal to -10%.|Difference in seroconversion rate|-3.73|||||TWO_SIDED|95.0|-6.93|-0.55|||||The asymptotic standardized 95% CI for the difference in seroconversion rate between HRV PCV-free Group minus HRV Group is computed using the method of Miettinen and Nurminen.|To demonstrate the immunological non-inferiority of HRV PCV-free Group as compared to HRV Group in terms of seroconversion rates 1 month post-Dose 2.||-0.55|-6.93|
72616972|NCT06025695|144765198|NON_INFERIORITY|NI was to be demonstrated if the LL of the two-sided 95% CI for the ratio of anti-RV IgA Ab GMC between the HRV PCV-free group and HRV group is greater than or equal to 0.67.|GMC Ratio|0.71|||||TWO_SIDED|95.0|0.6|0.84|||||The comparison is done using the group GMC ratio (HRV PCV-free/HRV) (ANOVA model applied to the log10-transformed titers). The ANOVA model included the group as a fixed effect.|To demonstrate the non-inferiority of the HRV PCV-free Group as compared to HRV Group in terms of serum anti-RV IgA Ab concentrations 1 month post-Dose 2.||0.84|0.60|
72616973|NCT06025695|144765199|NON_INFERIORITY|NI was to be demonstrated if the LL of the two-sided asymptotic standardized 95% CI for the difference in the percentage between the HRV PCV-free group and HRV group is greater than or equal to -10%.|Difference in percentage|-6.37|||||TWO_SIDED|95.0|-10.81|-1.92|||||The asymptotic standardized 95% CI for the difference in in the percentage between HRV PCV-free Group minus HRV Group is computed using the method of Miettinen and Nurminen.|To demonstrate the immunological non-inferiority of HRV PCV-free Group as compared to HRV Group in terms of percentage of participants with anti-RV IgA antibody concentrations \>=90 U/mL 1 month post-Dose 2.||-1.92|-10.81|
72616974|NCT03834883|144765203|SUPERIORITY|||||||0.07|||||||Mixed Models Analysis|||||||0.07
72616975|NCT03834883|144765204|SUPERIORITY|||||||0.006|||||||Mixed Models Analysis|||||||0.006
72616976|NCT03834883|144765205|SUPERIORITY|||||||0.16|||||||Mixed Models Analysis|||||||0.16
72616977|NCT03834883|144765206|SUPERIORITY|||||||0.002|||||||Mixed Models Analysis|||||||0.002
72616978|NCT03834883|144765207|SUPERIORITY|||||||0.2|||||||Mixed Models Analysis|||||||0.20
72616979|NCT03834883|144765208|SUPERIORITY|||||||0.01|||||||Mixed Models Analysis|||||||0.01
72616980|NCT03834883|144765210|SUPERIORITY|||||||0.015|||||||Mixed Models Analysis|||||||0.015
72616981|NCT03834883|144765211|SUPERIORITY|||||||0.0005|||||||Mixed Models Analysis|||||||0.0005
72616982|NCT03834883|144765212|SUPERIORITY|||||||0.017|||||||Mixed Models Analysis|||||||0.017
72616983|NCT03834883|144765213|SUPERIORITY|||||||0.83|||||||Mixed Models Analysis|||||||0.83
72616984|NCT03834883|144765214|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||||||<0.0001
72616985|NCT01301092|144765217|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Mean|0.443|||||TWO_SIDED|90.0|0.395|0.497|||Mixed Linear effects model analyses|||||0.497|0.395|
72616986|NCT01301092|144765218|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Mean|2.1|||||TWO_SIDED|90.0|1.84|2.41|||Mixed Linear effects model analyses|||||2.41|1.84|
72616987|NCT01301092|144765219|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Means|0.962|||||TWO_SIDED|90.0|0.858|1.08|||Mixed Linear effects model analyses|||||1.08|0.858|
72616988|NCT01301092|144765220|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Means|1.05|||||TWO_SIDED|90.0|0.924|1.19|||Mixed Linear effects model analyses|||||1.19|0.924|
72616989|NCT00727064|144765234|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA|PM compared to EM using least squares geometric means. Analysis of variance with phenotype and sequence as factors.||||||<0.001
72616990|NCT00727064|144765235|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA|PM compared to EM using least squares geometric means. Analysis of variance with phenotype and sequence as factors.||||||<0.001
72616991|NCT00727064|144765236|SUPERIORITY_OR_OTHER|||||||0.004|||||||ANOVA|PM compared to EM using least squares geometric means. Analysis of variance with phenotype and sequence as factors.||||||0.004
72616992|NCT00727064|144765237|SUPERIORITY_OR_OTHER|||||||0.018|||||||ANOVA|PM compared to EM using least squares geometric means. Analysis of variance with phenotype and sequence as factors.||||||0.018
72616993|NCT00727064|144765238|SUPERIORITY_OR_OTHER|||||||0.081|||||||ANOVA|PM compared to EM using least squares geometric means. Analysis of variance with phenotype and sequence as factors.||||||0.081
72616994|NCT00727064|144765239|SUPERIORITY_OR_OTHER|||||||0.427|||||||ANOVA|PM compared to EM using least squares geometric means. Analysis of variance with phenotype and sequence as factors.||||||0.427
72616995|NCT00126737|144765240|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.395||||0.0129|TWO_SIDED|95.0|-11.41|-1.38|||ANCOVA|Co-variates entered into the model were BMI and WOMAC function subscale.||||-1.38|-11.41|0.0129
72616996|NCT00126737|144765240|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.174||||0.0535|TWO_SIDED|95.0|-10.43|0.079|||ANCOVA|Covariates entered into the model were BMI and WOMAC function||||0.079|-10.43|0.0535
72616997|NCT00126737|144765241|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.545||||0.0307|TWO_SIDED|95.0|0.432|8.659|||ANCOVA|||||8.659|0.432|0.0307
72616998|NCT00126737|144765243|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|39.94||||0.0158|TWO_SIDED|95.0|7.655|72.215|||ANCOVA|Total disease (co-morbidity) as covariate was entered into the model||||72.215|7.655|0.0158
72616999|NCT00126737|144765243|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|62.25||||0.0002|TWO_SIDED|95.0|29.97|94.54|||ANCOVA|Total disease (co-morbidity) as covariate was entered into the model||||94.54|29.97|0.0002
72617000|NCT00126737|144765243|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|43.95||||0.0056|TWO_SIDED|95.0|12.54|75.36|||ANCOVA|Total disease (co-morbidity) as covariate was entered into the model||||75.36|12.54|0.0056
72617001|NCT00126737|144765244|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|28.129||||0.0018|TWO_SIDED|95.0|10.767|45.492|||ANCOVA|Kellgren Lawrence Scale was entered into the model||||45.492|10.767|0.0018
72617002|NCT00126737|144765244|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|26.71||||0.0024|TWO_SIDED|95.0|9.675|43.746|||ANCOVA|Kellgren Lawrence scale was entered into the model||||43.746|9.675|0.0024
72617003|NCT00126737|144765244|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|18.747||||0.0368|TWO_SIDED|95.0|1.169|36.325|||ANCOVA|Kellgren Lawrence Scale was entered into the model||||36.325|1.169|0.0368
72617004|NCT00666978|144765439|SUPERIORITY|The x2 test was used to determine whether there was a difference between treatment groups (bupropion SR vs placebo) in verified 7-day point prevalence abstinence at week 26, imputing the missing participants as smokers.|Odds Ratio (OR)|1.39||||0.23|TWO_SIDED|95.0|0.82|2.35||All tests of statistical significance were two-sided, and all P values less than .05 were considered statistically significant.|t-test, 2 sided||Raw proportions were used to estimate the verified cessation rate in each group and corresponding odds ratio along with its 95% confidence interval .|Based on our previous studies, sample size was determined a priori assuming a two-sided x2 test with a type I error rate of .05, a power of 80%, and a cotinine-verified abstinence rate of 15% in the placebo group and 25% in the bupropion SR group at week 26, with the assumption that those lost to follow-up would be imputed as smokers.||2.35|0.82|.23
72617005|NCT00666978|144765440|OTHER||Odds Ratio (OR)|0.97||||0.0022|TWO_SIDED|95.0|0.95|0.99||This reflects Week 7.|Regression, Logistic||This reflects Week 7.|||0.99|0.95|0.0022
72617006|NCT00666978|144765441|OTHER||Odds Ratio (OR)|2.82|||<|0.05|TWO_SIDED|||||Analysis relied on examining quit rates using linear regression, where the hydroxybupropion was a significant predictor of smoking cessation. CYP2B6 genotype was not a direct significant predictor of cessation in either the placebo or bupropion arm.|Regression, Linear||Bupropion adherent individuals with higher hydroxybupropion levels were more likely to be abstinent at Weeks 3, 7 and 26 compared to individuals with lower hydroxybupropion levels.|||||<0.05
72617007|NCT03055195|144765443|OTHER||Proportions Difference|11.0|||||TWO_SIDED|90.0|-1.1|23.3|||||Difference in Proportions between Mepolizumab 100 mg SC versus Placebo SC has been presented.|||23.3|-1.1|
72371612|NCT00669409|144253448|SUPERIORITY_OR_OTHER_LEGACY||Least Mean Square Difference|-12.8|STANDARD_ERROR_OF_MEAN|10.48|||TWO_SIDED|95.0|-33.5|8.0||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||8.0|-33.5|
72371613|NCT00669409|144253449|SUPERIORITY_OR_OTHER_LEGACY||Least Mean Square Difference|11.4|STANDARD_ERROR_OF_MEAN|7.98|||TWO_SIDED|95.0|-4.4|27.2||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||27.2|-4.4|
72617008|NCT03055195|144765445|OTHER||Proportion Difference|-1.0|||||TWO_SIDED|90.0|-14.0|12.6|||||Difference in Proportions between Mepolizumab 100 mg SC Versus Placebo SC at Week 4 has been presented.|||12.6|-14.0|
72617009|NCT03055195|144765445|OTHER||Proportion Difference|11.0|||||TWO_SIDED|90.0|-1.1|23.3|||||Difference in Proportions between Mepolizumab 100 mg SC Versus Placebo SC at Week 8 has been presented.|||23.3|-1.1|
72617010|NCT03055195|144765445|OTHER||Proportion Difference|11.0|||||TWO_SIDED|90.0|-1.1|23.3|||||Difference in Proportions between Mepolizumab 100 mg SC Versus Placebo SC at Week 12 has been presented.|||23.3|-1.1|
72617011|NCT03055195|144765445|OTHER||Proportion Difference|11.0|||||TWO_SIDED|90.0|-1.1|23.3|||||Difference in Proportions between Mepolizumab 100 mg SC Versus Placebo SC at Week 16 has been presented.|||23.3|-1.1|
72617012|NCT03055195|144765445|OTHER||Proportion Difference|6.0|||||TWO_SIDED|90.0|-3.3|14.4|||||Difference in Proportions between Mepolizumab 100 mg SC Versus Placebo SC at Week 20 has been presented.|||14.4|-3.3|
72617013|NCT01967277|144765500|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||t-test, 2 sided|||H0: µL ≤ µs Versus Ha: µL \> µs||||<0.001
72617014|NCT01028560|144765513|OTHER||Slope|0.19|STANDARD_ERROR_OF_MEAN|0.22||0.38|TWO_SIDED|95.0|-0.24|0.63|||Mixed Models Analysis||The above is the slope for immunotherapy group . The (quadratic) slope is for 1 month increase in time.|Linear mixed effects model (LME) with random coefficients model was fitted with Restricted Maximum Likelihood estimation. The functional form of the model was quadratic and the model adjusted for gender, race, ethnicity and number of asthma hospitalizations since birth. Unequal data collection were smoothed over two month period with a median score values.||0.63|-0.24|0.38
72622297|NCT04250207|144774536|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.|||||>|0.9999|||||||Chi-square or Fisher exact|||Week 52||||> 0.9999
72622298|NCT04250207|144774537|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.||||||0.0093|||||||Chi-square or Fisher exact|||Week 3||||0.0093
72622299|NCT04250207|144774537|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.|||||>|0.9999|||||||Chi-square or Fisher exact|||Week 3||||> 0.9999
72622300|NCT04250207|144774537|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.||||||0.0006|||||||Chi-square or Fisher exact|||Week 5||||0.0006
72432385|NCT02696785|144377177|SUPERIORITY||LSMean Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.33||0.002|TWO_SIDED|95.0|-1.7|-0.4|||Mixed Models Analysis|||||-0.4|-1.7|0.002
72493565|NCT03850912|144516304|SUPERIORITY||Odds Ratio (OR)|0.795|||<|0.001|TWO_SIDED|95.0|0.737|0.858|||Regression, Logistic|||Adjusted analysis comparing intervention responders versus non-responders (medical oncology patients only)||0.858|0.737|<0.001
72493566|NCT03850912|144516304|SUPERIORITY||Odds Ratio (OR)|0.739|||<|0.001|TWO_SIDED|95.0|0.686|0.796|||Regression, Logistic|||Adjusted analysis comparing intervention responders versus non-responders (surgical patients only)||0.796|0.686|<0.001
72493567|NCT02189850|144516335|SUPERIORITY|||||||0.923|||||||Cochran-Mantel-Haenszel|||||||0.923
72493568|NCT01844895|144516344|SUPERIORITY_OR_OTHER||geometric mean ratio|0.91|||||TWO_SIDED|90.0|0.83|1.0||||||A mixed-effect model of log (Cminss) with device and substudy baseline weight category (\< 60 kg,60-100 kg, \> 100 kg) as fixed effects and participant as a random effect was used. Point estimates and 90% CIs for device differences on the log scale were exponentiated to obtain estimates for ratios of geometric means on the original scale. No adjustment was made for multiplicity. PK comparability was concluded if the 90% CIs for the ratios of geometric means were contained within 80% to 125%.||1.00|0.83|
72493569|NCT00511355|144516356|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0849||95.0||||No correction for multiple testing was made.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for age class applied on the changes from baseline.||P-value compares the change from baseline to Cycle 6 between treatment groups.||||0.0849
72493570|NCT00511355|144516358|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0||||No correction for multiple testing was made.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for age class applied on the changes from baseline.||P-value compares the change from baseline to Cycle 6 between treatment groups.||||<.0001
72493571|NCT00511355|144516359|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4191||95.0||||No correction for multiple testing was made.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for age class applied on the changes from baseline.||P-value compares the change from baseline to Cycle 6 between treatment groups.||||0.4191
72493572|NCT00511355|144516360|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001||95.0||||No correction for multiple testing was made.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for age class applied on the changes from baseline.||P-value compares the change from baseline to Cycle 6 between treatment groups.||||0.0010
72555034|NCT03086460|144641771|SUPERIORITY||Mean Difference (Final Values)|0.074||||0.012|TWO_SIDED|95.0|0.017|0.131|||ANCOVA|||"Day 14~Comparison groups were:~Treatment B (CHF 1531 pMDI 12 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.131|0.017|0.012
72555035|NCT03086460|144641771|SUPERIORITY||Mean Difference (Final Values)|0.06||||0.037|TWO_SIDED|95.0|0.004|0.116|||ANCOVA|||"Day 14~Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.116|0.004|0.037
72555036|NCT03086460|144641771|SUPERIORITY||Mean Difference (Final Values)|0.082||||0.003|TWO_SIDED|95.0|0.028|0.136|||ANCOVA|||"Day 14~Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.136|0.028|0.003
72555037|NCT03086460|144641771|SUPERIORITY||Mean Difference (Final Values)|0.074||||0.006|TWO_SIDED|95.0|0.021|0.127|||ANCOVA|||"Day 14~Comparison groups were:~Treatment F ( Perforomist® IS 40 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.127|0.021|0.006
72555038|NCT03086460|144641771|SUPERIORITY||Mean Difference (Final Values)|0.031||||0.282|TWO_SIDED|95.0|-0.025|0.087|||ANCOVA|||"Day 14~Comparison groups were:~Treatment B (CHF 1531 pMDI 12 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.087|-0.025|0.282
72555039|NCT03086460|144641771|SUPERIORITY||Mean Difference (Final Values)|0.017||||0.554|TWO_SIDED|95.0|-0.039|0.072|||ANCOVA|||"Day 14~Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.072|-0.039|0.554
72555040|NCT03086460|144641771|SUPERIORITY||Mean Difference (Final Values)|0.039||||0.149|TWO_SIDED|95.0|-0.014|0.091|||ANCOVA|||"Day 14~Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.091|-0.014|0.149
72555041|NCT03086460|144641771|SUPERIORITY||Mean Difference (Final Values)|-0.014||||0.636|TWO_SIDED|95.0|-0.072|0.044|||ANCOVA|||"Day 14~Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment B (CHF 1531 pMDI 12 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.044|-0.072|0.636
72493573|NCT00511355|144516364|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3779||95.0||||No correction for multiple testing was made.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for age class applied on the changes from baseline.||P-value compares the change from baseline to Cycle 6 between treatment groups.||||0.3779
72493574|NCT00511355|144516365|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5027||95.0||||No correction for multiple testing was made.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for age class applied on the changes from baseline.||P-value compares the change from baseline to Cycle 6 between treatment groups.||||0.5027
72555042|NCT03086460|144641771|SUPERIORITY||Mean Difference (Final Values)|0.008||||0.775|TWO_SIDED|95.0|-0.047|0.063|||ANCOVA|||"Day 14~Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment B (CHF 1531 pMDI 12 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.063|-0.047|0.775
72617015|NCT01028560|144765513|OTHER||Slope|0.55|STANDARD_ERROR_OF_MEAN|0.22||0.013|TWO_SIDED|95.0|0.11|0.99|||Mixed Models Analysis|The above (quadratic) slope is for control group|The above is the (quadratic) slope is for control group and is for 1 month increase in time.|Linear mixed effects model (LME) with random coefficients model was fitted with Restricted Maximum Likelihood estimation. The functional form of the model was quadratic and the model adjusted for gender, race, ethnicity and number of asthma hospitalizations since birth. Unequal data collection were smoothed over two month period with median score values.||0.99|0.11|0.013
72617016|NCT01028560|144765513|OTHER||Mean Difference (Final Values)|0.13|STANDARD_ERROR_OF_MEAN|4.97||0.978|TWO_SIDED|95.0|-11.76|12.03||Post estimation means were tested between the intervention arms after LME model at year 1 and the p- values were adjusted using Bonferroni correction.|contrast testing post mixed model||The difference is IT-Control group and the confidence interval is Bonferroni CI|Linear mixed effects model (LME) with random coefficients model was fitted with Restricted Maximum Likelihood estimation. The functional form of the model was quadratic and the model adjusted for gender, race, ethnicity and number of asthma hospitalizations since birth. Unequal data collection between immunotherapy and control groups were smoothed over two month period with a median score values.||12.03|-11.76|0.978
72617017|NCT01028560|144765513|OTHER||Mean Difference (Final Values)|-1.72|STANDARD_ERROR_OF_MEAN|5.89||0.77|TWO_SIDED|95.0|-15.83|12.38||Post estimation means were tested between the intervention arms after LME model at year 2 and the p- value was unadjusted p value|contrast testing post mixed model]||The difference is IT-Control group and the confidence interval is Bonferroni CI|Linear mixed effects model (LME) with random coefficients model was fitted with Restricted Maximum Likelihood estimation. The functional form of the model was quadratic and the model adjusted for gender, race, ethnicity and number of asthma hospitalizations since birth. Unequal data collection between immunotherapy and control groups were smoothed over two month period with a median score values.||12.38|-15.83|0.77
72617018|NCT01028560|144765513|OTHER||Mean Difference (Final Values)|-1.85|STANDARD_ERROR_OF_MEAN|7.39||0.8|TWO_SIDED|95.0|-19.54|15.84||Post estimation means were tested between the intervention arms after LME model at year 3 and the p- values were adjusted using Bonferroni correction.|contrast testing post mixed model||The difference is IT-Control group and the confidence interval is Bonferroni CI|Linear mixed effects model (LME) with random coefficients model was fitted with Restricted Maximum Likelihood estimation. The functional form of the model was quadratic and the model adjusted for gender, race, ethnicity and number of asthma hospitalizations since birth. Unequal data collection between immunotherapy and control groups were smoothed over two month period with a median score values.||15.84|-19.54|0.80
72617019|NCT01028560|144765514|SUPERIORITY|||||||0.677||||||Chi-square test (proportion of new sensitizations versus unchanged or lost sensitizations in each group, intention-to treat analysis).|Chi-squared|||||||0.677
72617020|NCT01028560|144765515|SUPERIORITY||Slope|0.56||||0.546|TWO_SIDED|95.0|-2.18|3.29||Test of parallelism (group x time) hypothesis P-value.|covariance pattern (rep. measure) model|Within group difference p-values ( baseline vs 3-years) in control and intervention arm were 0.56 and 0.20 respectively.|The estimated slope reported is for year 3 from the covariance pattern model with autoregressive covariance structure.|Covariance Pattern Model with autoregressive covariance structure with REML (Restricted Estimation of Maximum Likelihood) with time and role as categorical variable was modeled.||3.29|-2.18|0.5460
72617021|NCT01028560|144765516|SUPERIORITY||Rate ratio|1.27||||0.289|TWO_SIDED|95.0|0.82|1.96||Poisson regression model for treatment arm adjusting for gender, race and history of hospitalization was used to analyze the corticosteroid burst and the time period contributed by each child in years were fitted as offset.|Poisson regression|Poisson regression model with robust variance with contributed person years used as offset was modeled.||Null hypothesis = Incidence rate of CSB in each group are same. Poisson regression adjusting for gender, race and history of hospitalization was used to analyze the corticosteroid burst.||1.96|0.82|0.289
72617022|NCT01243424|144765520|NON_INFERIORITY|This was the first step in a pre-defined hierarchical testing approach. The upper bound of the confidence interval (CI) of the Hazard ratio (HR) of linagliptin vs. glimepiride was compared with this noninferiority margin for the testing of non-inferiority. All non-inferiority tests were based on a margin of 1.3.|Hazard Ratio (HR)|0.98|||<|0.0001|TWO_SIDED|95.47|0.84|1.14||P-values derived from Wald´s Chi-square test for non-inferiority were calculated.|Regression, Cox|Cox proportional-hazard model with factor treatment was applied to compare linagliptin with glimepiride||||1.14|0.84|<0.0001
72617023|NCT01243424|144765520|SUPERIORITY|This was the second step in a pre-defined hierarchical testing approach.|Hazard Ratio (HR)|0.98||||0.3813|TWO_SIDED|95.47|0.84|1.14||P-values derived from Wald´s Chi-square test.|Regression, Cox|Cox proportional-hazard model with factor treatment was applied to compare linagliptin with glimepiride.||||1.14|0.84|0.3813
72617024|NCT01243424|144765521|SUPERIORITY|This was the third step in a pre-defined hierarchical testing approach.|Hazard Ratio (HR)|0.99||||0.4334|TWO_SIDED|95.47|0.86|1.14||P-values derived from Wald´s Chi-square test for non-inferiority.|Regression, Cox|Cox proportional-hazard model with factor treatment was applied to compare linagliptin with glimepiride.||||1.14|0.86|0.4334
72617025|NCT01243424|144765522|OTHER||Odds Ratio (OR)|1.68|||<|0.0001|TWO_SIDED|95.47|1.43|1.96||p-value derived from logistic regression.|Regression, Logistic||Odds ratio and confidence interval are based on logistic regression with factor for treatment.|||1.96|1.43|<0.0001
72617026|NCT01243424|144765523|OTHER||Odds Ratio (OR)|1.29||||0.0004|TWO_SIDED|95.47|1.11|1.48||p-value derived from logistic regression.|Regression, Logistic||Odds ratio and confidence interval are based on logistic regression with factor for treatment.|This was the fifth step in a pre-defined hierarchical testing approach.||1.48|1.11|0.0004
72617027|NCT01243424|144765527|OTHER||Hazard Ratio (HR)|0.96||||0.5249|TWO_SIDED|95.0|0.85|1.09||p-value derived from Wald´s chi-square test.|Regression, Cox||Hazard ratio and confidence interval derived from Cox regression with factor treatment.|This was the fifth step in a pre-defined hierarchical testing approach.||1.09|0.85|0.5249
72617028|NCT01243424|144765528|OTHER||Mean Difference (Final Values)|-0.09|STANDARD_ERROR_OF_MEAN|0.03||0.0023|TWO_SIDED|95.0|-0.15|-0.03|||ANCOVA|The Analysis of Covariance (ANCOVA) model includes the fixed categorical effect of treatment and the continuous covariate of baseline HbA1c.|Mean difference = Linagliptin mean - Glimepiride mean|This was the fifth step in a pre-defined hierarchical testing approach.||-0.03|-0.15|0.0023
72617029|NCT01243424|144765529|OTHER||Mean Difference (Final Values)|-7.3|STANDARD_ERROR_OF_MEAN|1.2|<|0.0001|TWO_SIDED|95.0|-9.7|-4.8|||ANCOVA|The ANCOVA model includes the fixed categorical effect of treatment and the continuous covariate of baseline FPG.|Mean difference = Linagliptin mean - Glimepiride mean|This was the fifth step in a pre-defined hierarchical testing approach.||-4.8|-9.7|<0.0001
72617030|NCT01243424|144765530|OTHER||Mean Difference (Final Values)|0.4|STANDARD_ERROR_OF_MEAN|0.9||0.64|TWO_SIDED|95.47|-1.3|2.1|||ANCOVA|The ANCOVA model includes the fixed categorical effect of treatment and the continuous covariate of baseline LDL cholesterol.|Mean difference = Linagliptin mean - Glimepiride mean|LDL cholesterol, this was the fifth step in a pre-defined hierarchical testing approach.||2.1|-1.3|0.6400
72617031|NCT01243424|144765530|OTHER||Mean Difference (Final Values)|0.5|STANDARD_ERROR_OF_MEAN|0.2||0.0497|TWO_SIDED|95.0|0.0|1.0|||ANCOVA|The ANCOVA model includes the fixed categorical effect of treatment and the continuous covariate of baseline HDL cholesterol.|Mean difference = Linagliptin mean - Glimepiride mean|HDL cholesterol, this was the fifth step in a pre-defined hierarchical testing approach.||1.0|0.0|0.0497
72617032|NCT01243424|144765530|OTHER||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|1.0||0.6823|TWO_SIDED|95.0|-2.4|1.6|||ANCOVA|The ANCOVA model includes the fixed categorical effect of treatment and the continuous covariate of baseline total cholesterol.|Mean difference = Linagliptin mean - Glimepiride mean|Total cholesterol, this was the fifth step in a pre-defined hierarchical testing approach.||1.6|-2.4|0.6823
72617033|NCT01243424|144765531|OTHER||Mean Difference (Final Values)|-3.5|STANDARD_ERROR_OF_MEAN|3.1||0.2678|TWO_SIDED|95.0|-9.6|2.7|||ANCOVA|The ANCOVA model includes the fixed categorical effect of treatment and the continuous covariate of baseline FPG.|Mean difference = Linagliptin mean - Glimepiride mean|This was the fifth step in a pre-defined hierarchical testing approach.||2.7|-9.6|0.2678
72617034|NCT01243424|144765532|OTHER||Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.01||0.5165|TWO_SIDED|95.0|-0.03|0.01|||ANCOVA|The ANCOVA model includes the fixed categorical effect of treatment and the continuous covariate of baseline creatinine.|Mean difference = Linagliptin mean - Glimepiride mean|This was the fifth step in a pre-defined hierarchical testing approach.||0.01|-0.03|0.5165
72617035|NCT01243424|144765533|OTHER||Mean Difference (Final Values)|1.0|STANDARD_ERROR_OF_MEAN|0.4||0.5165|TWO_SIDED|95.0|0.2|1.8|||ANCOVA|The ANCOVA model includes the fixed categorical effect of treatment and the continuous covariate of baseline eGFR.|Mean difference = Linagliptin mean - Glimepiride mean|This was the fifth step in a pre-defined hierarchical testing approach.||1.8|0.2|0.5165
72617036|NCT01243424|144765534|OTHER||geometric mean (gMean) ratio (%)|0.97||||0.2921|TWO_SIDED|95.0|0.91|1.03|||ANCOVA|The ANCOVA model includes the fixed categorical effect of treatment and the continuous covariate of baseline UACR.|gMean ration= Linagliptin mean/ Glimepiride mean|This was the fifth step in a pre-defined hierarchical testing approach.||1.03|0.91|0.2921
72617037|NCT01243424|144765536|EQUIVALENCE|This was the fifth step in a pre-defined hierarchical testing approach.|Mean Difference (Net)|4.13||||0.8402|TWO_SIDED|95.0|-36.46|44.71|||ANCOVA|The ANCOVA model includes the fixed categorical effects of treatment and the continuous covariate of baseline ISR.|Mean difference= Linagliptin mean- Glimepiride mean|||44.71|-36.46|0.8402
72617038|NCT01243424|144765537|OTHER||Odds Ratio (OR)|1.01||||0.9112|TWO_SIDED|95.0|0.86|1.18|||Regression, Logistic|Logistic regression model with terms for treatment as a fixed effect with Wald confidence Interval was used.|Linagliptin vs. Glimepiride odds is presented.|This was the fifth step in a pre-defined hierarchical testing approach.||1.18|0.86|0.9112
72617039|NCT00397930|144765543|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.79|STANDARD_ERROR_OF_MEAN|0.3||0.009|TWO_SIDED|||||Between-group differences are expressed as differences in mean Post-Pre change for the global sleep quality PSQI score.|ANCOVA|ANCOVA with post-intervention PSQI score as the outcome, with Group as the factor, and pre-intervention PSQI score as the covariate.|The negative estimated value indicates that the mean Post-Pre change for the YOCAS group was less than that of the Control group.|"H0: There is no statistically significant difference in global sleep quality between post-treatment cancer survivors under the standardized yoga intervention and control protocol at the 0.05 two-sided significance level.~Ha: There is a statistically significant difference in global sleep quality between post-treatment cancer survivors under the standardized yoga intervention and control protocol at the 0.05 two-sided significance level."||||0.009
72617040|NCT03737032|144765569|SUPERIORITY|||||||0.8|||||||ANOVA|||Null hypothesis: post-TBS dmPFC activation will not vary by TBS condition. This is tested using the main effect of condition in a repeated measures model.||||0.80
72617041|NCT03737032|144765570|SUPERIORITY|||||||0.23|||||||ANOVA|Repeated measures ANOVA with time (pre or post), condition (cTBS, iTBS, sham TBS), and time\*condition effects.||Null hypothesis: pre-post change in positive affect will not vary by TBS condition. This is tested using the interaction of time\*condition in a repeated measures model.||||0.23
72617042|NCT03737032|144765571|SUPERIORITY|||||||0.84|||||||ANOVA|||Null hypothesis: post-TBS functional connectivity between the dmPFC and ventral striatum (VS) will not vary by TBS condition. This is tested using the main effect of condition in a repeated measures model.||||0.84
72617043|NCT05156125|144765594|SUPERIORITY||Risk Difference (RD)|16.1||||0.0184|TWO_SIDED|95.0|2.58|29.05|||Cochran-Mantel-Haenszel|||At 13 weeks||29.05|2.58|0.0184
72617044|NCT05156125|144765594|SUPERIORITY||Risk Difference (RD)|13.1||||0.041|TWO_SIDED|95.0|-0.03|25.58|||Cochran-Mantel-Haenszel|||At 13 weeks||25.58|-0.03|0.0410
72617045|NCT05156125|144765595|SUPERIORITY||Risk Difference (RD)|20.6||||0.007|TWO_SIDED|95.0|5.73|34.42|||Cochran-Mantel-Haenszel|||At 13 weeks||34.42|5.73|0.0070
72617046|NCT05156125|144765595|SUPERIORITY||Risk Difference (RD)|17.3||||0.0162|TWO_SIDED|95.0|2.75|30.67|||Cochran-Mantel-Haenszel|||At Week 13||30.67|2.75|0.0162
72617047|NCT05156125|144765596|SUPERIORITY||Risk Difference (RD)|16.5||||0.0448|TWO_SIDED|95.0|0.65|31.37|||Cochran-Mantel-Haenszel|||||31.37|0.65|0.0448
72617048|NCT05156125|144765596|SUPERIORITY||Risk Difference (RD)|16.0||||0.0417|TWO_SIDED|95.0|0.23|30.58|||Cochran-Mantel-Haenszel|||At Week 13||30.58|0.23|0.0417
72617049|NCT05156125|144765597|SUPERIORITY||Risk Difference (RD)|11.5||||0.0499|TWO_SIDED|95.0|-0.99|23.38|||Cochran-Mantel-Haenszel|||||23.38|-0.99|0.0499
72617050|NCT05156125|144765597|SUPERIORITY||Risk Difference (RD)|21.4||||0.0011|TWO_SIDED|95.0|7.94|33.53|||Cochran-Mantel-Haenszel|||At Week 13||33.53|7.94|0.0011
72617051|NCT05156125|144765598|SUPERIORITY|||||||0.0072|||||||Cochran-Mantel-Haenszel|||At Week 13||||0.0072
72617052|NCT05156125|144765598|SUPERIORITY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||At Week 13||||<0.0001
72617053|NCT05075772|144765607|OTHER||Ratio of gMeans (%)|46.3|||||TWO_SIDED|90.0|38.3|55.9|||||"Ratio of Geometric Least Squares Means (gMeans) was calculated as (gMean of SC injection (T))/(gMean of IV infusion (R)).~Intra-matched-pair geometric coefficient of variation=28.2."|The statistical model used for the analysis of this primary endpoint was an analysis of variance (ANOVA). The PK endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model. The model included a fixed effect for treatment assignment and a random effect for matching pair (each matched pair in the study was assigned a number for the analysis).||55.9|38.3|
72617054|NCT05075772|144765608|OTHER||Ratio of gMeans (%)|26.8|||||TWO_SIDED|90.0|23.2|31.1|||||"Ratio of Geometric Least Squares Means (gMeans) was calculated as (gMean of SC injection (T))/(gMean of IV infusion (R)). Intra-matched-pair geometric coefficient of variation=22.5"|The statistical model used for the analysis of this primary endpoint was an analysis of variance (ANOVA). The PK endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model. The model included a fixed effect for treatment assignment and a random effect for matching pair (each matched pair in the study was assigned a number for the analysis).||31.1|23.2|
72617055|NCT05075772|144765609|OTHER||Ratio of gMeans (%)|47.0|||||TWO_SIDED|90.0|39.0|56.6|||||"Ratio of Geometric Least Squares Means (gMeans) was calculated as (gMean of SC injection (T))/(gMean of IV infusion (R)).~Intra-matched-pair geometric coefficient of variation=27.7."|The statistical model used for the analysis of this secondary endpoint was an analysis of variance (ANOVA). The PK endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model. The model included a fixed effect for treatment assignment and a random effect for matching pair (each matched pair in the study was assigned a number for the analysis).||56.6|39.0|
72617056|NCT00927186|144765612|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The pre-specified significance level 0.05 was used.|Wilcoxon (Mann-Whitney)|||||||<0.001
72617057|NCT00927186|144765613|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.002
72617058|NCT00927186|144765614|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for 6 months.|Wilcoxon (Mann-Whitney)|||||||<0.001
72555043|NCT03086460|144641771|SUPERIORITY||Mean Difference (Final Values)|0.022||||0.425|TWO_SIDED|95.0|-0.032|0.077|||ANCOVA|||"Day 14~Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment C (CHF 1531 pMDI 24 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.077|-0.032|0.425
72555044|NCT03086460|144641772|SUPERIORITY||Mean Difference (Final Values)|0.122|||<|0.001|TWO_SIDED|95.0|0.058|0.187|||ANCOVA|||"Day 1~Comparison groups were:~Treatment A (CHF 1531 pMDI 6 μg TDD) versus Treatment E (Placebo).~This secondary efficacy variable was analyzed using the ANCOVA model that was also used for the primary efficacy analysis, without adjusting for multiplicity."||0.187|0.058|<0.001
72555045|NCT03086460|144641772|SUPERIORITY||Mean Difference (Final Values)|0.15|||<|0.001|TWO_SIDED|95.0|0.085|0.215|||ANCOVA|||"Day 1~Comparison groups were:~Treatment B (CHF 1531 pMDI 12 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.215|0.085|<0.001
72555046|NCT03086460|144641772|SUPERIORITY||Mean Difference (Final Values)|0.124|||<|0.001|TWO_SIDED|95.0|0.059|0.189|||ANCOVA|||"Day 1~Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.189|0.059|<0.001
72555047|NCT03086460|144641772|SUPERIORITY||Mean Difference (Final Values)|0.18|||<|0.001|TWO_SIDED|95.0|0.118|0.242|||ANCOVA|||"Day 1~Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.242|0.118|<0.001
72617059|NCT00927186|144765614|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||P-value is for 24 months.|Wilcoxon (Mann-Whitney)|||||||0.002
72617060|NCT00927186|144765615|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for double labels (DL) and no labels (NL).|Wilcoxon (Mann-Whitney)|||||||<0.001
72617061|NCT00927186|144765615|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for double labels (DL), imputed single labels (ISL) and no labels (NL).|Wilcoxon (Mann-Whitney)|||||||<0.001
72617062|NCT00927186|144765616|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||P-value is for double labels (DL) and no labels (NL).|Wilcoxon (Mann-Whitney)|||||||0.002
72617063|NCT00927186|144765616|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||P-value is for double labels (DL), imputed single labels (ISL) and no labels (NL).|Wilcoxon (Mann-Whitney)|||||||0.002
72617064|NCT00927186|144765617|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for double labels (DL) and no labels (NL) at 6 months.|Wilcoxon (Mann-Whitney)|||||||<0.001
72617065|NCT00927186|144765617|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for double labels (DL), imputed single labels (ISL) and no labels (NL) at 6 months.|Wilcoxon (Mann-Whitney)|||||||<0.001
72617066|NCT00927186|144765617|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||P-value is for double labels (DL) and no labels (NL) at 24 months.|Wilcoxon (Mann-Whitney)|||||||0.002
72617067|NCT00927186|144765617|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||P-value is for double labels (DL), imputed single labels (ISL) and no labels (NL) at 24 months.|Wilcoxon (Mann-Whitney)|||||||0.002
72617068|NCT00927186|144765618|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for double labels (DL) and no labels (NL).|Wilcoxon (Mann-Whitney)|||||||<0.001
72617069|NCT00927186|144765618|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for double labels (DL), imputed single labels (ISL) and no labels (NL).|Wilcoxon (Mann-Whitney)|||||||<0.001
72617070|NCT00927186|144765619|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||P-value is for double labels (DL) and no labels (NL).|Wilcoxon (Mann-Whitney)|||||||0.002
72617071|NCT00927186|144765619|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||P-value is for double labels (DL), imputed single labels (ISL) and no labels (NL).|Wilcoxon (Mann-Whitney)|||||||0.002
72617072|NCT00927186|144765620|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for double labels (DL) and no labels (NL) at 6 months.|Wilcoxon (Mann-Whitney)|||||||<0.001
72617073|NCT00927186|144765620|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for double labels (DL), imputed single labels (ISL) and no labels (NL) at 6 months.|Wilcoxon (Mann-Whitney)|||||||<0.001
72617074|NCT00927186|144765620|SUPERIORITY_OR_OTHER|||||||0.003||95.0||||P-value is for double labels (DL) and no labels (NL) at 24 months.|Wilcoxon (Mann-Whitney)|||||||0.003
72617075|NCT00927186|144765620|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||P-value is for double labels (DL), imputed single labels (ISL) and no labels (NL) at 24 months.|Wilcoxon (Mann-Whitney)|||||||0.002
72617076|NCT00927186|144765621|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for double labels (DL) and no labels (NL).|Wilcoxon (Mann-Whitney)|||||||<0.001
72617077|NCT00927186|144765621|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for double labels (DL), imputed single labels (ISL) and no labels (NL).|Wilcoxon (Mann-Whitney)|||||||<0.001
72617078|NCT00927186|144765622|SUPERIORITY_OR_OTHER|||||||0.02||95.0||||P-value is for double labels (DL) and no labels (NL).|Wilcoxon (Mann-Whitney)|||||||0.020
72617079|NCT00927186|144765622|SUPERIORITY_OR_OTHER|||||||0.005||95.0||||P-value is for double labels (DL), imputed single labels (ISL) and no labels (NL).|Wilcoxon (Mann-Whitney)|||||||0.005
72617080|NCT00927186|144765623|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for double labels (DL) and no labels (NL) at 6 months.|Wilcoxon (Mann-Whitney)|||||||<0.001
72371614|NCT00669409|144253449|SUPERIORITY_OR_OTHER_LEGACY||Least Mean Square Difference|-5.4|STANDARD_ERROR_OF_MEAN|7.98|||TWO_SIDED|95.0|-21.2|10.3||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||10.3|-21.2|
72617081|NCT00927186|144765623|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for double labels (DL), imputed single labels (ISL) and no labels (NL) at 6 months.|Wilcoxon (Mann-Whitney)|||||||<0.001
72617082|NCT00927186|144765623|SUPERIORITY_OR_OTHER|||||||0.039||95.0||||P-value is for double labels (DL) and no labels (NL) at 24 months.|Wilcoxon (Mann-Whitney)|||||||0.039
72617083|NCT00927186|144765623|SUPERIORITY_OR_OTHER|||||||0.025||95.0||||P-value is for double labels (DL), imputed single labels (ISL) and no labels (NL) at 24 months.|Wilcoxon (Mann-Whitney)|||||||0.025
72617084|NCT00927186|144765624|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for double labels (DL) and no labels (NL).|Wilcoxon (Mann-Whitney)|||||||<0.001
72617085|NCT00927186|144765624|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for double labels (DL), imputed single labels (ISL) and no labels (NL).|Wilcoxon (Mann-Whitney)|||||||<0.001
72617086|NCT00927186|144765625|SUPERIORITY_OR_OTHER|||||||0.05||95.0||||P-value is for double labels (DL) and no labels (NL).|Wilcoxon (Mann-Whitney)|||||||0.050
72617087|NCT00927186|144765625|SUPERIORITY_OR_OTHER|||||||0.016||95.0||||P-value is for double labels (DL), imputed single labels (ISL) and no labels (NL).|Wilcoxon (Mann-Whitney)|||||||0.016
72617088|NCT00927186|144765626|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for double labels (DL) and no labels (NL) at 6 months.|Wilcoxon (Mann-Whitney)|||||||<0.001
72617089|NCT00927186|144765626|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for double labels (DL), imputed single labels (ISL) and no labels (NL) at 6 months.|Wilcoxon (Mann-Whitney)|||||||<0.001
72617090|NCT00927186|144765626|SUPERIORITY_OR_OTHER|||||||0.003||95.0||||P-value is for double labels (DL) and no labels (NL) at 24 months.|Wilcoxon (Mann-Whitney)|||||||0.003
72617091|NCT00927186|144765626|SUPERIORITY_OR_OTHER|||||||0.003||95.0||||P-value is for double labels (DL), imputed single labels (ISL) and no labels (NL) at 24 months.|Wilcoxon (Mann-Whitney)|||||||0.003
72617092|NCT00927186|144765627|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for double labels (DL) and no labels (NL).|Wilcoxon (Mann-Whitney)|||||||<0.001
72617093|NCT00927186|144765627|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for double labels (DL), imputed single labels (ISL) and no labels (NL).|Wilcoxon (Mann-Whitney)|||||||<0.001
72617094|NCT00927186|144765628|SUPERIORITY_OR_OTHER|||||||0.906||95.0||||P-value is for double labels (DL) and no labels (NL).|Wilcoxon (Mann-Whitney)|||||||0.906
72617095|NCT00927186|144765628|SUPERIORITY_OR_OTHER|||||||0.159||95.0||||P-value is for double labels (DL), imputed single labels (ISL) and no labels (NL).|Wilcoxon (Mann-Whitney)|||||||0.159
72617096|NCT00927186|144765629|SUPERIORITY_OR_OTHER|||||||0.049||95.0||||P-value is for double labels (DL) and no labels (NL) at 6 months.|Wilcoxon (Mann-Whitney)|||||||0.049
72617097|NCT00927186|144765629|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for double labels (DL), imputed single labels (ISL) and no labels (NL) at 6 months.|Wilcoxon (Mann-Whitney)|||||||<0.001
72617098|NCT00927186|144765629|SUPERIORITY_OR_OTHER|||||||0.151||95.0||||P-value is for double labels (DL) and no labels (NL) at 24 months.|Wilcoxon (Mann-Whitney)|||||||0.151
72617099|NCT00927186|144765629|SUPERIORITY_OR_OTHER|||||||0.196||95.0||||P-value is for double labels (DL), imputed single labels (ISL) and no labels (NL) at 24 months.|Wilcoxon (Mann-Whitney)|||||||0.196
72617100|NCT00927186|144765630|SUPERIORITY_OR_OTHER|||||||0.502||95.0||||P-value is for double labels (DL) and no labels (NL).|Wilcoxon (Mann-Whitney)|||||||0.502
72617101|NCT00927186|144765630|SUPERIORITY_OR_OTHER|||||||0.597||95.0||||P-value is for double labels (DL), imputed single labels (ISL) and no labels (NL).|Wilcoxon (Mann-Whitney)|||||||0.597
72617102|NCT00927186|144765631|SUPERIORITY_OR_OTHER|||||||0.077||95.0||||P-value is for double labels (DL) and no labels (NL).|Wilcoxon (Mann-Whitney)|||||||0.077
72432386|NCT02696785|144377177|SUPERIORITY||LSMean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.33||0.035|TWO_SIDED|95.0|-1.3|0.0|||Mixed Models Analysis|||||-0.0|-1.3|0.035
72617103|NCT00927186|144765631|SUPERIORITY_OR_OTHER|||||||0.358||95.0||||P-value is for double labels (DL), imputed single labels (ISL) and no labels (NL).|Wilcoxon (Mann-Whitney)|||||||0.358
72617104|NCT00927186|144765632|SUPERIORITY_OR_OTHER|||||||0.647||95.0||||P-value is for double labels (DL) and no labels (NL) at 6 months.|Wilcoxon (Mann-Whitney)|||||||0.647
72617105|NCT00927186|144765632|SUPERIORITY_OR_OTHER|||||||0.12||95.0||||P-value is for double labels (DL), imputed single labels (ISL) and no labels (NL) at 6 months.|Wilcoxon (Mann-Whitney)|||||||0.120
72617106|NCT00927186|144765632|SUPERIORITY_OR_OTHER|||||||0.695||95.0||||P-value is for double labels (DL) and no labels (NL) at 24 months.|Wilcoxon (Mann-Whitney)|||||||0.695
72617107|NCT00927186|144765632|SUPERIORITY_OR_OTHER|||||||1||95.0||||P-value is for double labels (DL), imputed single labels (ISL) and no labels (NL) at 24 months.|Wilcoxon (Mann-Whitney)|||||||1.00
72617108|NCT00927186|144765633|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for double labels (DL) and no labels (NL).|Wilcoxon (Mann-Whitney)|||||||<0.001
72617109|NCT00927186|144765633|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for double labels (DL), imputed single labels (ISL) and no labels (NL).|Wilcoxon (Mann-Whitney)|||||||<0.001
72617110|NCT00927186|144765634|SUPERIORITY_OR_OTHER|||||||1||95.0||||P-value is for double labels (DL) and no labels (NL).|Wilcoxon (Mann-Whitney)|||||||1.00
72617111|NCT00927186|144765634|SUPERIORITY_OR_OTHER|||||||0.198||95.0||||P-value is for double labels (DL), imputed single labels (ISL) and no labels (NL).|Wilcoxon (Mann-Whitney)|||||||0.198
72617112|NCT00927186|144765635|SUPERIORITY_OR_OTHER|||||||0.022||95.0||||P-value is for double labels (DL) and no labels (NL) at 6 months.|Wilcoxon (Mann-Whitney)|||||||0.022
72617113|NCT00927186|144765635|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for double labels (DL), imputed single labels (ISL) and no labels (NL) at 6 months.|Wilcoxon (Mann-Whitney)|||||||<0.001
72617114|NCT00927186|144765635|SUPERIORITY_OR_OTHER|||||||0.151||95.0||||P-value is for double labels (DL) and no labels (NL) at 24 months.|Wilcoxon (Mann-Whitney)|||||||0.151
72617115|NCT00927186|144765635|SUPERIORITY_OR_OTHER|||||||0.139||95.0||||-value is for double labels (DL), imputed single labels (ISL) and no labels (NL) at 24 months.|Wilcoxon (Mann-Whitney)|||||||0.139
72432387|NCT02696785|144377178|SUPERIORITY||LSMean Difference|-1.2|STANDARD_ERROR_OF_MEAN|0.57||0.041|TWO_SIDED|95.0|-2.3|0.0|||Mixed Models Analysis|||||-0.0|-2.3|0.041
72617116|NCT00927186|144765636|SUPERIORITY_OR_OTHER|||||||0.154||95.0||||P-value is for double labels (DL) and no labels (NL).|Wilcoxon (Mann-Whitney)|||||||0.154
72617117|NCT00927186|144765636|SUPERIORITY_OR_OTHER|||||||0.052||95.0||||P-value is for double labels (DL), imputed single labels (ISL) and no labels (NL).|Wilcoxon (Mann-Whitney)|||||||0.052
72617118|NCT00927186|144765637|SUPERIORITY_OR_OTHER|||||||0.906||95.0||||P-value is for double labels (DL) and no labels (NL).|Wilcoxon (Mann-Whitney)|||||||0.906
72617119|NCT00927186|144765637|SUPERIORITY_OR_OTHER|||||||0.159||95.0||||P-value is for double labels (DL), imputed single labels (ISL) and no labels (NL).|Wilcoxon (Mann-Whitney)|||||||0.159
72617120|NCT00927186|144765638|SUPERIORITY_OR_OTHER|||||||0.979||95.0||||P-value is for double labels (DL) and no labels (NL) at 6 months.|Wilcoxon (Mann-Whitney)|||||||0.979
72617121|NCT00927186|144765638|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||P-value is for double labels (DL), imputed single labels (ISL) and no labels (NL) at 6 months.|Wilcoxon (Mann-Whitney)|||||||0.002
72617122|NCT00927186|144765638|SUPERIORITY_OR_OTHER|||||||0.695||95.0||||P-value is for double labels (DL) and no labels (NL) at 24 months.|Wilcoxon (Mann-Whitney)|||||||0.695
72617123|NCT00927186|144765638|SUPERIORITY_OR_OTHER|||||||0.853||95.0||||P-value is for double labels (DL), imputed single labels (ISL) and no labels (NL) at 24 months.|Wilcoxon (Mann-Whitney)|||||||0.853
72617124|NCT00927186|144765639|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for sLS/BS.|Wilcoxon (Mann-Whitney)|||||||<0.001
72617125|NCT00927186|144765639|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for dLS/BS.|Wilcoxon (Mann-Whitney)|||||||<0.001
72617126|NCT00927186|144765640|SUPERIORITY_OR_OTHER|||||||0.006||95.0||||P-value is for sLS/BS.|Wilcoxon (Mann-Whitney)|||||||0.006
72617127|NCT00927186|144765640|SUPERIORITY_OR_OTHER|||||||0.001||95.0||||P-value is for dLS/BS.|Wilcoxon (Mann-Whitney)|||||||0.001
72617128|NCT00927186|144765641|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for sLS/BS at 6 months.|Wilcoxon (Mann-Whitney)|||||||<0.001
72617129|NCT00927186|144765641|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for dLS/BS at 6 months.|Wilcoxon (Mann-Whitney)|||||||<0.001
72617130|NCT00927186|144765641|SUPERIORITY_OR_OTHER|||||||0.004||95.0||||P-value is for sLS/BS at 24 months.|Wilcoxon (Mann-Whitney)|||||||0.004
72617131|NCT00927186|144765641|SUPERIORITY_OR_OTHER|||||||0.006||95.0||||P-value is for dLS/BS at 24 months.|Wilcoxon (Mann-Whitney)|||||||0.006
72617132|NCT00927186|144765642|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||"P-value is a comparison of No Label vs. Single, Double, Single and Double Label."|Fisher Exact|||||||<0.001
72617133|NCT00927186|144765643|SUPERIORITY_OR_OTHER|||||||0.033||95.0||||"P-value is a comparison of No Label vs. Single, Double, Single and Double Label."|Fisher Exact|||||||0.033
72617134|NCT00927186|144765644|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||"P-value is a comparison of No Label vs. Single, Double, Single and Double Label at 6 months."|Fisher Exact|||||||<0.001
72617135|NCT00927186|144765644|SUPERIORITY_OR_OTHER|||||||0.009||95.0||||"P-value is a comparison of No Label vs. Single, Double, Single and Double Label at 24 months."|Fisher Exact|||||||0.009
72617136|NCT00927186|144765645|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.002
72617137|NCT00927186|144765646|SUPERIORITY_OR_OTHER|||||||0.906||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.906
72617138|NCT00927186|144765647|SUPERIORITY_OR_OTHER|||||||0.536||95.0||||P-value is for 6 months.|Wilcoxon (Mann-Whitney)|||||||0.536
72617139|NCT00927186|144765647|SUPERIORITY_OR_OTHER|||||||0.896||95.0||||P-value is for 24 months.|Wilcoxon (Mann-Whitney)|||||||0.896
72617140|NCT00927186|144765648|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.001
72617141|NCT00927186|144765649|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.002
72617142|NCT00927186|144765650|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.001
72617143|NCT00927186|144765651|SUPERIORITY_OR_OTHER|||||||0.008||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.008
72617144|NCT00927186|144765652|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for 6 months.|Wilcoxon (Mann-Whitney)|||||||<0.001
72617145|NCT00927186|144765652|SUPERIORITY_OR_OTHER|||||||0.006||95.0||||P-value is for 24 months.|Wilcoxon (Mann-Whitney)|||||||0.006
72617146|NCT00927186|144765653|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.001
72555048|NCT03086460|144641772|SUPERIORITY||Mean Difference (Final Values)|0.177|||<|0.001|TWO_SIDED|95.0|0.115|0.238|||ANCOVA|||"Day 1~Comparison groups were:~Treatment F ( Perforomist® IS 40 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.238|0.115|<0.001
72555049|NCT03086460|144641772|SUPERIORITY||Mean Difference (Final Values)|0.028||||0.41|TWO_SIDED|95.0|-0.039|0.094|||ANCOVA|||"Day 1~Comparison groups were:~Treatment B (CHF 1531 pMDI 12 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.094|-0.039|0.410
72555050|NCT03086460|144641772|SUPERIORITY||Mean Difference (Final Values)|0.002||||0.961|TWO_SIDED|95.0|-0.063|0.066|||ANCOVA|||"Day 1~Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.066|-0.063|0.961
72555051|NCT03086460|144641772|SUPERIORITY||Mean Difference (Final Values)|0.057||||0.07|TWO_SIDED|95.0|-0.005|0.119|||ANCOVA|||"Day 1~Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.119|-0.005|0.070
72555052|NCT03086460|144641772|SUPERIORITY||Mean Difference (Final Values)|-0.026||||0.454|TWO_SIDED|95.0|-0.095|0.043|||ANCOVA|||"Day 1~Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment B (CHF 1531 pMDI 12 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.043|-0.095|0.454
72555053|NCT03086460|144641772|SUPERIORITY||Mean Difference (Final Values)|0.03||||0.37|TWO_SIDED|95.0|-0.035|0.095|||ANCOVA|||"Day 1~Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment B (CHF 1531 pMDI 12 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.095|-0.035|0.370
72555054|NCT03086460|144641772|SUPERIORITY||Mean Difference (Final Values)|0.056||||0.086|TWO_SIDED|95.0|-0.008|0.12|||ANCOVA|||"Day 1~Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment C (CHF 1531 pMDI 24 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.120|-0.008|0.086
72555055|NCT03086460|144641772|SUPERIORITY||Mean Difference (Final Values)|0.086||||0.011|TWO_SIDED|95.0|0.02|0.151|||ANCOVA|||"Day 14~Comparison groups were:~Treatment A (CHF 1531 pMDI 6 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.151|0.020|0.011
72555056|NCT03086460|144641772|SUPERIORITY||Mean Difference (Final Values)|0.097||||0.005|TWO_SIDED|95.0|0.029|0.164|||ANCOVA|||"Day 14~Comparison groups were:~Treatment B (CHF 1531 pMDI 12 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.164|0.029|0.005
72555057|NCT03086460|144641772|SUPERIORITY||Mean Difference (Final Values)|0.087||||0.01|TWO_SIDED|95.0|0.021|0.153|||ANCOVA|||"Day 14~Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.153|0.021|0.010
72555058|NCT03086460|144641772|SUPERIORITY||Mean Difference (Final Values)|0.145|||<|0.001|TWO_SIDED|95.0|0.081|0.208|||ANCOVA|||"Day 14~Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.208|0.081|<0.001
72555059|NCT03086460|144641772|SUPERIORITY||Mean Difference (Final Values)|0.127|||<|0.001|TWO_SIDED|95.0|0.065|0.189|||ANCOVA|||"Day 14~Comparison groups were:~Treatment F ( Perforomist® IS 40 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.189|0.065|<0.001
72555060|NCT03086460|144641772|SUPERIORITY||Mean Difference (Final Values)|0.011||||0.74|TWO_SIDED|95.0|-0.055|0.078|||ANCOVA|||"Day 14~Comparison groups were:~Treatment B (CHF 1531 pMDI 12 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.078|-0.055|0.740
72555061|NCT03086460|144641772|SUPERIORITY||Mean Difference (Final Values)|0.001||||0.973|TWO_SIDED|95.0|-0.064|0.066|||ANCOVA|||"Day 14~Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.066|-0.064|0.973
72555062|NCT03086460|144641772|SUPERIORITY||Mean Difference (Final Values)|0.059||||0.064|TWO_SIDED|95.0|-0.003|0.122|||ANCOVA|||"Day 14~Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.122|-0.003|0.064
72555063|NCT03086460|144641772|SUPERIORITY||Mean Difference (Final Values)|-0.01||||0.774|TWO_SIDED|95.0|-0.079|0.059|||ANCOVA|||"Day 14~Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment B (CHF 1531 pMDI 12 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.059|-0.079|0.774
72555064|NCT03086460|144641772|SUPERIORITY||Mean Difference (Final Values)|0.048||||0.151|TWO_SIDED|95.0|-0.018|0.113|||ANCOVA|||"Day 14~Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment B (CHF 1531 pMDI 12 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.113|-0.018|0.151
72617147|NCT00927186|144765654|SUPERIORITY_OR_OTHER|||||||0.079||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.079
72617148|NCT00927186|144765655|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for 6 months.|Wilcoxon (Mann-Whitney)|||||||<0.001
72617149|NCT00927186|144765655|SUPERIORITY_OR_OTHER|||||||0.039||95.0||||P-value is for 24 months.|Wilcoxon (Mann-Whitney)|||||||0.039
72617150|NCT00927186|144765656|SUPERIORITY_OR_OTHER|||||||0.014||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.014
72617151|NCT00927186|144765657|SUPERIORITY_OR_OTHER|||||||0.079||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.079
72617152|NCT00927186|144765658|SUPERIORITY_OR_OTHER|||||||0.027||95.0||||P-value is for 6 months.|Wilcoxon (Mann-Whitney)|||||||0.027
72617153|NCT00927186|144765658|SUPERIORITY_OR_OTHER|||||||0.268||95.0||||P-value is for 24 months.|Wilcoxon (Mann-Whitney)|||||||0.268
72432388|NCT02696785|144377178|SUPERIORITY||LSMean Difference|-0.9|STANDARD_ERROR_OF_MEAN|0.59||0.125|TWO_SIDED|95.0|-2.1|0.3|||Mixed Models Analysis|||||0.3|-2.1|0.125
72555065|NCT03086460|144641772|SUPERIORITY||Mean Difference (Final Values)|0.058||||0.076|TWO_SIDED|95.0|-0.006|0.122|||ANCOVA|||"Day 14~Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment C (CHF 1531 pMDI 24 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.122|-0.006|0.076
72555066|NCT03086460|144641773|SUPERIORITY||Mean Difference (Final Values)|0.114||||0.003|TWO_SIDED|95.0|0.039|0.19|||ANCOVA|||"Day 1~Comparison groups were:~Treatment A (CHF 1531 pMDI 6 μg TDD) versus Treatment E (Placebo).~This secondary efficacy variable was analyzed using the ANCOVA model that was also used for the primary efficacy analysis, without adjusting for multiplicity."||0.190|0.039|0.003
72555067|NCT03086460|144641773|SUPERIORITY||Mean Difference (Final Values)|0.13|||<|0.001|TWO_SIDED|95.0|0.055|0.206|||ANCOVA|||"Day 1~Comparison groups were:~Treatment B (CHF 1531 pMDI 12 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.206|0.055|<0.001
72555068|NCT03086460|144641773|SUPERIORITY||Mean Difference (Final Values)|0.137|||<|0.001|TWO_SIDED|95.0|0.061|0.213|||ANCOVA|||"Day 1~Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.213|0.061|<0.001
72555069|NCT03086460|144641773|SUPERIORITY||Mean Difference (Final Values)|0.151|||<|0.001|TWO_SIDED|95.0|0.078|0.223|||ANCOVA|||"Day 1~Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.223|0.078|<0.001
72555070|NCT03086460|144641773|SUPERIORITY||Mean Difference (Final Values)|0.168|||<|0.001|TWO_SIDED|95.0|0.097|0.24|||ANCOVA|||"Day 1~Comparison groups were:~Treatment F ( Perforomist® IS 40 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.240|0.097|<0.001
72555071|NCT03086460|144641773|SUPERIORITY||Mean Difference (Final Values)|0.016||||0.679|TWO_SIDED|95.0|-0.061|0.093|||ANCOVA|||"Day 1~Comparison groups were:~Treatment B (CHF 1531 pMDI 12 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.093|-0.061|0.679
72555072|NCT03086460|144641773|SUPERIORITY||Mean Difference (Final Values)|0.023||||0.549|TWO_SIDED|95.0|-0.052|0.098|||ANCOVA|||"Day 1~Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.098|-0.052|0.549
72555073|NCT03086460|144641773|SUPERIORITY||Mean Difference (Final Values)|0.036||||0.323|TWO_SIDED|95.0|-0.036|0.109|||ANCOVA|||"Day 1~Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.109|-0.036|0.323
72555074|NCT03086460|144641773|SUPERIORITY||Mean Difference (Final Values)|0.007||||0.866|TWO_SIDED|95.0|-0.073|0.087|||ANCOVA|||"Day 1~Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment B (CHF 1531 pMDI 12 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.087|-0.073|0.866
72555075|NCT03086460|144641773|SUPERIORITY||Mean Difference (Final Values)|0.02||||0.596|TWO_SIDED|95.0|-0.055|0.096|||ANCOVA|||"Day 1~Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment B (CHF 1531 pMDI 12 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.096|-0.055|0.596
72555076|NCT03086460|144641773|SUPERIORITY|"Day 1~Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment C (CHF 1531 pMDI 24 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."|Mean Difference (Final Values)|0.014||||0.72|TWO_SIDED|95.0|-0.061|0.088|||ANCOVA|||||0.088|-0.061|0.720
72555077|NCT03086460|144641773|SUPERIORITY||Mean Difference (Final Values)|0.112||||0.003|TWO_SIDED|95.0|0.038|0.185|||ANCOVA|||"Day 14~Comparison groups were:~Treatment A (CHF 1531 pMDI 6 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.185|0.038|0.003
72555078|NCT03086460|144641773|SUPERIORITY||Mean Difference (Final Values)|0.133|||<|0.001|TWO_SIDED|95.0|0.057|0.209|||ANCOVA|||"Day 14~Comparison groups were:~Treatment B (CHF 1531 pMDI 12 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.209|0.057|<0.001
72555079|NCT03086460|144641773|SUPERIORITY||Mean Difference (Final Values)|0.106||||0.005|TWO_SIDED|95.0|0.032|0.18|||ANCOVA|||"Day 14~Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.180|0.032|0.005
72555080|NCT03086460|144641773|SUPERIORITY||Mean Difference (Final Values)|0.152|||<|0.001|TWO_SIDED|95.0|0.081|0.223|||ANCOVA|||"Day 14~Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.223|0.081|<0.001
72555081|NCT03086460|144641773|SUPERIORITY||Mean Difference (Final Values)|0.142|||<|0.001|TWO_SIDED|95.0|0.072|0.212|||ANCOVA|||"Day 14~Comparison groups were:~Treatment F ( Perforomist® IS 40 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.212|0.072|<0.001
72555082|NCT03086460|144641773|SUPERIORITY||Mean Difference (Final Values)|0.021||||0.573|TWO_SIDED|95.0|-0.053|0.096|||ANCOVA|||"Day 14~Comparison groups were:~Treatment B (CHF 1531 pMDI 12 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.096|-0.053|0.573
72555083|NCT03086460|144641773|SUPERIORITY||Mean Difference (Final Values)|-0.006||||0.881|TWO_SIDED|95.0|-0.078|0.067|||ANCOVA|||"Day 14~Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.067|-0.078|0.881
72555084|NCT03086460|144641773|SUPERIORITY||Mean Difference (Final Values)|0.04||||0.261|TWO_SIDED|95.0|-0.03|0.11|||ANCOVA|||"Day 14~Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.110|-0.030|0.261
72617154|NCT00927186|144765659|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.001
72617155|NCT00927186|144765660|SUPERIORITY_OR_OTHER|||||||0.025||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.025
72617156|NCT00927186|144765661|SUPERIORITY_OR_OTHER|||||||0.012||95.0||||P-value is for 6 months.|Wilcoxon (Mann-Whitney)|||||||0.012
72617157|NCT00927186|144765661|SUPERIORITY_OR_OTHER|||||||0.092||95.0||||P-value is for 24 months.|Wilcoxon (Mann-Whitney)|||||||0.092
72617158|NCT00927186|144765662|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for change from baseline at 1 month.|t-test, 2 sided|||||||<0.001
72617159|NCT00927186|144765662|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for change from baseline at 3 months.|t-test, 2 sided|||||||<0.001
72617160|NCT00927186|144765662|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for change from baseline at 6 months.|t-test, 2 sided|||||||<0.001
72617161|NCT00927186|144765663|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||||||<0.001
72617162|NCT00927186|144765664|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for change from baseline at 1 month.|t-test, 2 sided|||||||<0.001
72617163|NCT00927186|144765664|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for change from baseline at 3 months.|t-test, 2 sided|||||||<0.001
72617164|NCT00927186|144765664|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for change from baseline at 6 months.|t-test, 2 sided|||||||<0.001
72617165|NCT00927186|144765665|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||||||<0.001
72617166|NCT00927186|144765666|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for change from baseline at 1 month.|t-test, 2 sided|||||||<0.001
72617167|NCT00927186|144765666|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for change from baseline at 3 months.|t-test, 2 sided|||||||<0.001
72617168|NCT00927186|144765666|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for change from baseline at 6 months.|t-test, 2 sided|||||||<0.001
72617169|NCT00927186|144765667|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||||||<0.001
72617170|NCT02734147|144765700|OTHER|||||||0.631|||||||Other|||||||0.631
72617171|NCT02734147|144765701|OTHER|||||||0.64|||||||Other|||||||0.640
72617172|NCT02734147|144765702|SUPERIORITY|||||||0.006|||||||Fisher Exact|||||||0.006
72617173|NCT02734147|144765703|SUPERIORITY|||||||0.655|||||||Fisher Exact|||||||0.655
72617174|NCT02734147|144765704|SUPERIORITY|||||||0.133|||||||Fisher Exact|||||||0.133
72617175|NCT02734147|144765705|OTHER|||||||0.566|||||||Other|||||||0.566
72617176|NCT02734147|144765706|SUPERIORITY|||||||1|||||||Chi-squared|||||||1.0
72617177|NCT04098302|144765730|SUPERIORITY|||||||0.012|||||||Mixed Models Analysis|||||||0.012
72617178|NCT04098302|144765731|SUPERIORITY|||||||0.019|||||||Mixed Models Analysis|||||||0.019
72617179|NCT04098302|144765732|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
72617180|NCT04098302|144765733|SUPERIORITY|||||||0.29|||||||Mixed Models Analysis|||||||0.29
72617181|NCT01810952|144765734|SUPERIORITY_OR_OTHER|||||||0.35||||||This is the p-value for Day 5|t-test, 2 sided|||||||0.35
72617182|NCT01810952|144765735|SUPERIORITY_OR_OTHER|||||||0.65|||||||Chi-squared|||||||0.65
72617183|NCT01810952|144765736|SUPERIORITY_OR_OTHER|||||||0.06||||||Comparison of the 5 day averages resulted in a p-value of 0.06.|t-test, 2 sided|||Daily values for each protocol were compared using t-tests.||||0.06
72617184|NCT01810952|144765737|SUPERIORITY_OR_OTHER||difference in binomial proportions|||||0.795||||||Comparison of the number of participants in each group with glucose value \<70 mg/dL resulted in p-value 0.795.|Chi-squared|||||||0.795
72617185|NCT01810952|144765738|SUPERIORITY_OR_OTHER|||||||0.055||||||Comparison between groups of percent of glucose values \>180 mg/dL.|Chi-squared|||Values in each group were compared by Chi squared.||||0.055
72617186|NCT01668537|144765760|NON_INFERIORITY|The non-inferiority margin to show that the FD formulation is non-inferior to the LF formulation in terms of ELISA GMTs at the peak visit (Week 6) was predefined as '1.5' for the GMT ratio (LF/FD). Non-inferiority is demonstrated if the upper 95% CI of the GMT ratio (LF/FD) is entirely below 1.5|GMT ratio (LF/FD)|0.796|||||TWO_SIDED|95.0|0.707|0.896||||||||0.896|0.707|
72617187|NCT05064800|144765778|OTHER||Ratio of Adjusted Geometric Means|233.06|||||TWO_SIDED|90.0|172.14|315.54|||Mixed Models Analysis|||Treatment 1 was Reference and Treatment 2 was Test. Natural log-transformed Cmax of dabigatran was analyzed using mixed effect model with treatment, period, sequence as fixed effects; participant within sequence as a random effect. Estimates of the adjusted mean differences(AMD) (Test-Reference) and 90%CIs were obtained from the model. The AMD and 90%CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90%CI for the ratios.||315.54|172.14|
72617188|NCT05064800|144765779|OTHER||Ratio of Adjusted Geometric Means|169.07|||||TWO_SIDED|90.0|135.25|211.35|||Mixed Models Analysis|||Treatment 1 was Reference and Treatment 2 was Test. Natural log-transformed AUCinf of dabigatran was analyzed using mixed effect model with treatment, period and sequence as fixed effects and participant in sequence as random effect. Estimates of the adjusted mean differences(AMD)(Test-Reference) and 90%CIs were obtained from the model. The AMD and 90%CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means(Test/Reference) and 90%CI for the ratios.||211.35|135.25|
72617189|NCT05064800|144765780|OTHER||Ratio of Adjusted Geometric Means|160.05|||||TWO_SIDED|90.0|119.19|214.9|||Mixed Models Analysis|||Treatment 1 was Reference and Treatment 2 was Test. Natural log-transformed AUClast of dabigatran was analyzed using mixed effect model with treatment, period and sequence as fixed effects and participant in sequence as random effect. Estimates of the adjusted mean differences(AMD)(Test-Reference) and 90%CIs were obtained from the model.The AMD and 90%CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means(Test/Reference) and 90%CI for the ratios.||214.90|119.19|
72622301|NCT04250207|144774537|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.||||||0.3449|||||||Chi-square or Fisher exact|||Week 5||||0.3449
72622302|NCT04250207|144774537|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.||||||0.0028|||||||Chi-square or Fisher exact|||Week 7||||0.0028
72617190|NCT05064800|144765781|OTHER||Ratio of Adjusted Geometric Means|171.91|||||TWO_SIDED|90.0|127.51|231.77|||Mixed Models Analysis|||Treatment 1 was Reference and Treatment 3 was Test. Natural log-transformed Cmax of dabigatran was analyzed using mixed effect model with treatment, period, sequence as fixed effects; participant within sequence as a random effect. Estimates of the adjusted mean differences(AMD) (Test-Reference) and 90%CIs were obtained from the model. The AMD and 90%CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90%CI for the ratios.||231.77|127.51|
72617191|NCT05064800|144765782|OTHER||Ratio of Adjusted Geometric Means|169.07|||||TWO_SIDED|90.0|135.25|211.35|||Mixed Models Analysis|||Treatment 1 was Reference and Treatment 3 was Test. Natural log-transformed AUCinf of dabigatran was analyzed using mixed effect model with treatment, period and sequence as fixed effects and participant in sequence as random effect. Estimates of the adjusted mean differences(AMD)(Test-Reference) and 90%CIs were obtained from the model. The AMD and 90%CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means(Test/Reference) and 90%CI for the ratios.||211.35|135.25|
72617192|NCT05064800|144765783|OTHER||Ratio of Adjusted Geometric Means|160.05|||||TWO_SIDED|90.0|119.19|214.9|||Mixed Models Analysis|||Treatment 1 was Reference and Treatment 3 was Test. Natural log-transformed AUClast of dabigatran was analyzed using mixed effect model with treatment, period and sequence as fixed effects and participant in sequence as random effect. Estimates of the adjusted mean differences(AMD)(Test-Reference) and 90%CIs were obtained from the model.The AMD and 90%CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means(Test/Reference) and 90%CI for the ratios.||214.90|119.19|
72617193|NCT04477486|144765798|SUPERIORITY|Comparing against a historical reference of 12.5% CRR.|||||<|0.001|||||||Exact Binomial Distribution|||||||<0.001
72617194|NCT02864914|144765836|OTHER||Adjusted incidence rate ratio|0.77|||||TWO_SIDED|95.0|0.5|1.19|||||Adjusted incidence rate ratio = incidence rate empagliflozin / incidence rate DPP-4 inhibitors|Adjusted IR ratio was generated overall with corresponding 95% CIs through the application of a Poisson regression model where the outcome was modelled as a function of treatment cohort (empagliflozin or DPP-4 inhibitors) and propensity score decile (specified as a categorical variable) with the log of time of exposure (in years) as the offset. If any variable remained unbalanced after trimming, it was added as an independent variable in the Poisson regression model.||1.19|0.50|
72617195|NCT02864914|144765836|OTHER||Adjusted incidence rate ratio|0.55|||||TWO_SIDED|95.0|0.23|1.32|||||Adjusted incidence rate ratio = incidence rate empagliflozin / incidence rate DPP-4 inhibitors|Adjusted IR ratio was generated overall with corresponding 95% CIs through the application of a Poisson regression model where the outcome was modelled as a function of treatment cohort (empagliflozin or DPP-4 inhibitors) and propensity score decile (specified as a categorical variable) with the log of time of exposure (in years) as the offset. If any variable remained unbalanced after trimming, it was added as an independent variable in the Poisson regression model.||1.32|0.23|
72617196|NCT02864914|144765836|OTHER||Adjusted incidence rate ratio|0.86|||||TWO_SIDED|95.0|0.52|1.41|||||Adjusted incidence rate ratio = incidence rate empagliflozin / incidence rate DPP-4 inhibitors|Adjusted IR ratio was generated overall with corresponding 95% CIs through the application of a Poisson regression model where the outcome was modelled as a function of treatment cohort (empagliflozin or DPP-4 inhibitors) and propensity score decile (specified as a categorical variable) with the log of time of exposure (in years) as the offset. If any variable remained unbalanced after trimming, it was added as an independent variable in the Poisson regression model.||1.41|0.52|
72617197|NCT02864914|144765837|OTHER||Adjusted incidence rate ratio|0.54|||||TWO_SIDED|95.0|0.41|0.73|||||Adjusted incidence rate ratio = incidence rate empagliflozin / incidence rate DPP-4 inhibitors|Adjusted IR ratio was generated overall with corresponding 95% CIs through the application of a Poisson regression model where the outcome was modelled as a function of treatment cohort (empagliflozin or DPP-4 inhibitors) and propensity score decile (specified as a categorical variable) with the log of time of exposure (in years) as the offset. If any variable remained unbalanced after trimming, it was added as an independent variable in the Poisson regression model.||0.73|0.41|
72617198|NCT02864914|144765837|OTHER||Adjusted incidence rate ratio|0.41|||||TWO_SIDED|95.0|0.3|0.55|||||Adjusted incidence rate ratio = incidence rate empagliflozin / incidence rate DPP-4 inhibitors|Adjusted IR ratio was generated overall with corresponding 95% CIs through the application of a Poisson regression model where the outcome was modelled as a function of treatment cohort (empagliflozin or DPP-4 inhibitors) and propensity score decile (specified as a categorical variable) with the log of time of exposure (in years) as the offset. If any variable remained unbalanced after trimming, it was added as an independent variable in the Poisson regression model.||0.55|0.30|
72617199|NCT02864914|144765837|OTHER||Adjusted incidence rate ratio|0.69|||||TWO_SIDED|95.0|0.45|1.05|||||Adjusted incidence rate ratio = incidence rate empagliflozin / incidence rate DPP-4 inhibitors|Adjusted IR ratio was generated overall with corresponding 95% CIs through the application of a Poisson regression model where the outcome was modelled as a function of treatment cohort (empagliflozin or DPP-4 inhibitors) and propensity score decile (specified as a categorical variable) with the log of time of exposure (in years) as the offset. If any variable remained unbalanced after trimming, it was added as an independent variable in the Poisson regression model.||1.05|0.45|
72617200|NCT02864914|144765837|OTHER||Adjusted incidence rate ratio|0.41|||||TWO_SIDED|95.0|0.2|0.86|||||Adjusted incidence rate ratio = incidence rate empagliflozin / incidence rate DPP-4 inhibitors|Adjusted IR ratio was generated overall with corresponding 95% CIs through the application of a Poisson regression model where the outcome was modelled as a function of treatment cohort (empagliflozin or DPP-4 inhibitors) and propensity score decile (specified as a categorical variable) with the log of time of exposure (in years) as the offset. If any variable remained unbalanced after trimming, it was added as an independent variable in the Poisson regression model.||0.86|0.20|
72617201|NCT02864914|144765837|OTHER||Adjusted incidence rate ratio|0.65|||||TWO_SIDED|95.0|0.56|0.76|||||Adjusted incidence rate ratio = incidence rate empagliflozin / incidence rate DPP-4 inhibitors|Adjusted IR ratio was generated overall with corresponding 95% CIs through the application of a Poisson regression model where the outcome was modelled as a function of treatment cohort (empagliflozin or DPP-4 inhibitors) and propensity score decile (specified as a categorical variable) with the log of time of exposure (in years) as the offset. If any variable remained unbalanced after trimming, it was added as an independent variable in the Poisson regression model.||0.76|0.56|
72617202|NCT02864914|144765838|OTHER||Adjusted incidence rate ratio|2.19|||||TWO_SIDED|95.0|1.74|2.76|||||Adjusted incidence rate ratio = incidence rate empagliflozin / incidence rate DPP-4 inhibitors|Adjusted IR ratio was generated overall with corresponding 95% CIs through the application of a Poisson regression model where the outcome was modelled as a function of treatment cohort (empagliflozin or DPP-4 inhibitors) and propensity score decile (specified as a categorical variable) with the log of time of exposure (in years) as the offset. If any variable remained unbalanced after trimming, it was added as an independent variable in the Poisson regression model.||2.76|1.74|
72617203|NCT02864914|144765838|OTHER||Adjusted incidence rate ratio|2.78|||||TWO_SIDED|95.0|1.77|4.36|||||Adjusted incidence rate ratio = incidence rate empagliflozin / incidence rate DPP-4 inhibitors|Adjusted IR ratio was generated overall with corresponding 95% CIs through the application of a Poisson regression model where the outcome was modelled as a function of treatment cohort (empagliflozin or DPP-4 inhibitors) and propensity score decile (specified as a categorical variable) with the log of time of exposure (in years) as the offset. If any variable remained unbalanced after trimming, it was added as an independent variable in the Poisson regression model.||4.36|1.77|
72617204|NCT02864914|144765838|OTHER||Adjusted incidence rate ratio|2.14|||||TWO_SIDED|95.0|1.11|4.12|||||Adjusted incidence rate ratio = incidence rate empagliflozin / incidence rate DPP-4 inhibitors|Adjusted IR ratio was generated overall with corresponding 95% CIs through the application of a Poisson regression model where the outcome was modelled as a function of treatment cohort (empagliflozin or DPP-4 inhibitors) and propensity score decile (specified as a categorical variable) with the log of time of exposure (in years) as the offset. If any variable remained unbalanced after trimming, it was added as an independent variable in the Poisson regression model.||4.12|1.11|
72617205|NCT02864914|144765838|OTHER||Adjusted incidence rate ratio|1.99|||||TWO_SIDED|95.0|1.48|2.66|||||Adjusted incidence rate ratio = incidence rate empagliflozin / incidence rate DPP-4 inhibitors|Adjusted IR ratio was generated overall with corresponding 95% CIs through the application of a Poisson regression model where the outcome was modelled as a function of treatment cohort (empagliflozin or DPP-4 inhibitors) and propensity score decile (specified as a categorical variable) with the log of time of exposure (in years) as the offset. If any variable remained unbalanced after trimming, it was added as an independent variable in the Poisson regression model.||2.66|1.48|
72617206|NCT02864914|144765839|OTHER||Adjusted incidence rate ratio|0.51|||||TWO_SIDED|95.0|0.37|0.72|||||Adjusted incidence rate ratio = incidence rate empagliflozin / incidence rate DPP-4 inhibitors|Adjusted IR ratio was generated overall with corresponding 95% CIs through the application of a Poisson regression model where the outcome was modelled as a function of treatment cohort (empagliflozin or DPP-4 inhibitors) and propensity score decile (specified as a categorical variable) with the log of time of exposure (in years) as the offset. If any variable remained unbalanced after trimming, it was added as an independent variable in the Poisson regression model.||0.72|0.37|
72617207|NCT02864914|144765840|OTHER||Adjusted incidence rate ratio|4.04|||||TWO_SIDED|95.0|3.46|4.71|||||Adjusted incidence rate ratio = incidence rate empagliflozin / incidence rate DPP-4 inhibitors|Adjusted IR ratio was generated overall with corresponding 95% CIs through the application of a Poisson regression model where the outcome was modelled as a function of treatment cohort (empagliflozin or DPP-4 inhibitors) and propensity score decile (specified as a categorical variable) with the log of time of exposure (in years) as the offset. If any variable remained unbalanced after trimming, it was added as an independent variable in the Poisson regression model.||4.71|3.46|
72617208|NCT02864914|144765841|OTHER||Adjusted incidence rate ratio|3.24|||||TWO_SIDED|95.0|2.81|3.74|||||Adjusted incidence rate ratio = incidence rate empagliflozin / incidence rate DPP-4 inhibitors|Adjusted IR ratio was generated overall with corresponding 95% CIs through the application of a Poisson regression model where the outcome was modelled as a function of treatment cohort (empagliflozin or DPP-4 inhibitors) and propensity score decile (specified as a categorical variable) with the log of time of exposure (in years) as the offset. If any variable remained unbalanced after trimming, it was added as an independent variable in the Poisson regression model.||3.74|2.81|
72617209|NCT02864914|144765842|OTHER||Adjusted incidence rate ratio|0.7|||||TWO_SIDED|95.0|0.56|0.88|||||Adjusted incidence rate ratio = incidence rate empagliflozin / incidence rate DPP-4 inhibitors|Adjusted IR ratio was generated overall with corresponding 95% CIs through the application of a Poisson regression model where the outcome was modelled as a function of treatment cohort (empagliflozin or DPP-4 inhibitors) and propensity score decile (specified as a categorical variable) with the log of time of exposure (in years) as the offset. If any variable remained unbalanced after trimming, it was added as an independent variable in the Poisson regression model.||0.88|0.56|
72617210|NCT02864914|144765842|OTHER||Adjusted incidence rate ratio|0.5|||||TWO_SIDED|95.0|0.29|0.85|||||Adjusted incidence rate ratio = incidence rate empagliflozin / incidence rate DPP-4 inhibitors|Adjusted IR ratio was generated overall with corresponding 95% CIs through the application of a Poisson regression model where the outcome was modelled as a function of treatment cohort (empagliflozin or DPP-4 inhibitors) and propensity score decile (specified as a categorical variable) with the log of time of exposure (in years) as the offset. If any variable remained unbalanced after trimming, it was added as an independent variable in the Poisson regression model.||0.85|0.29|
72622303|NCT04250207|144774537|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.||||||0.0028|||||||Chi-square or Fisher exact|||Week 7||||0.0028
72432389|NCT02696785|144377178|SUPERIORITY||LSMean Difference|-1.4|STANDARD_ERROR_OF_MEAN|0.58||0.013|TWO_SIDED|95.0|-2.6|-0.3|||Mixed Models Analysis|||||-0.3|-2.6|0.013
72617211|NCT02864914|144765842|OTHER||Adjusted incidence rate ratio|0.66|||||TWO_SIDED|95.0|0.34|1.29|||||Adjusted incidence rate ratio = incidence rate empagliflozin / incidence rate DPP-4 inhibitors|Adjusted IR ratio was generated overall with corresponding 95% CIs through the application of a Poisson regression model where the outcome was modelled as a function of treatment cohort (empagliflozin or DPP-4 inhibitors) and propensity score decile (specified as a categorical variable) with the log of time of exposure (in years) as the offset. If any variable remained unbalanced after trimming, it was added as an independent variable in the Poisson regression model.||1.29|0.34|
72617212|NCT02864914|144765842|OTHER||Adjusted incidence rate ratio|0.77|||||TWO_SIDED|95.0|0.61|0.97|||||Adjusted incidence rate ratio = incidence rate empagliflozin / incidence rate DPP-4 inhibitors|Adjusted IR ratio was generated overall with corresponding 95% CIs through the application of a Poisson regression model where the outcome was modelled as a function of treatment cohort (empagliflozin or DPP-4 inhibitors) and propensity score decile (specified as a categorical variable) with the log of time of exposure (in years) as the offset. If any variable remained unbalanced after trimming, it was added as an independent variable in the Poisson regression model.||0.97|0.61|
72617213|NCT02864914|144765843|OTHER||Adjusted incidence rate ratio|0.53|||||TWO_SIDED|95.0|0.43|0.65|||||Adjusted incidence rate ratio = incidence rate empagliflozin / incidence rate DPP-4 inhibitors|Adjusted IR ratio was generated overall with corresponding 95% CIs through the application of a Poisson regression model where the outcome was modelled as a function of treatment cohort (empagliflozin or DPP-4 inhibitors) and propensity score decile (specified as a categorical variable) with the log of time of exposure (in years) as the offset. If any variable remained unbalanced after trimming, it was added as an independent variable in the Poisson regression model.||0.65|0.43|
72617214|NCT02864914|144765844|OTHER||Adjusted incidence rate ratio|4.04|||||TWO_SIDED|95.0|3.44|4.75|||||Adjusted incidence rate ratio = incidence rate empagliflozin / incidence rate DPP-4 inhibitors|Adjusted IR ratio was generated overall with corresponding 95% CIs through the application of a Poisson regression model where the outcome was modelled as a function of treatment cohort (empagliflozin or DPP-4 inhibitors) and propensity score decile (specified as a categorical variable) with the log of time of exposure (in years) as the offset. If any variable remained unbalanced after trimming, it was added as an independent variable in the Poisson regression model.||4.75|3.44|
72617215|NCT02864914|144765845|OTHER||Adjusted incidence rate ratio|3.34|||||TWO_SIDED|95.0|2.83|3.95|||||Adjusted incidence rate ratio = incidence rate empagliflozin / incidence rate DPP-4 inhibitors|Adjusted IR ratio was generated overall with corresponding 95% CIs through the application of a Poisson regression model where the outcome was modelled as a function of treatment cohort (empagliflozin or DPP-4 inhibitors) and propensity score decile (specified as a categorical variable) with the log of time of exposure (in years) as the offset. If any variable remained unbalanced after trimming, it was added as an independent variable in the Poisson regression model.||3.95|2.83|
72617216|NCT01487161|144765866|SUPERIORITY||Mean Difference (Final Values)|-0.5||||0.1249|TWO_SIDED|90.0|-1.2|0.2|||Longitudinal mixed effect model|||||0.2|-1.2|0.1249
72617217|NCT01487161|144765867|SUPERIORITY||Mean Difference (Final Values)|-0.4||||0.2002|TWO_SIDED|90.0|-1.1|0.3|||Longitudinal mixed effect model|||||0.3|-1.1|0.2002
72617218|NCT01487161|144765868|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.5541|TWO_SIDED|90.0|-0.7|0.8|||Longitudinal mixed effect model|||||0.8|-0.7|0.5541
72617219|NCT01501513|144765927|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
72617220|NCT00567580|144765957|SUPERIORITY||||||<|0.001||||||One-sided significance level = 0.001|Z test|||Alternative hypotheses: 10% improvement in 5-year FFP in Arm 2 and 20% improvement in Arm 3, both relative to Arm 1, which has an assumed 5-year FFP of 70%. Sample size of 1587 (529/arm) with overall one-sided 0.025 alpha provides 90% power. Interim analyses (reported here) tested at one-sided significance level of 0.001. P\<0.001 indicates comparison crossed interim efficacy boundary. See Limitations and Caveats section.||||<0.001
72617221|NCT00567580|144765957|SUPERIORITY|||||||0.003|||||||Z-test|||Alternative hypotheses: 10% improvement in 5-year FFP in Arm 2 and 20% improvement in Arm 3, both relative to Arm 1, which has an assumed 5-year FFP of 70%. Sample size of 1587 (529/arm) with overall one-sided 0.025 alpha provides 90% power. Interim analyses (reported here) tested at one-sided significance level of 0.001. P\<0.001 indicates comparison crossed interim efficacy boundary. See Limitations and Caveats section.||||0.003
72617222|NCT00567580|144765957|SUPERIORITY||||||<|0.001|||||||Z-test|||Alternative hypotheses: 10% improvement in 5-year FFP in Arm 2 and 20% improvement in Arm 3, both relative to Arm 1, which has an assumed 5-year FFP of 70%. Sample size of 1587 (529/arm) with overall one-sided 0.025 alpha provides 90% power. Interim analyses (reported here) tested at one-sided significance level of 0.001. P\<0.001 indicates comparison crossed interim efficacy boundary. See Limitations and Caveats section.||||<0.001
72617223|NCT00567580|144765958|SUPERIORITY||Hazard Ratio (HR)|0.57|||<|0.001|TWO_SIDED|97.5|0.45|0.72||One-sided significance level = 0.0125|Log Rank||Reference level = PBRT Alone|||0.72|0.45|<0.001
72617224|NCT00567580|144765958|SUPERIORITY||Hazard Ratio (HR)|0.67|||<|0.001|TWO_SIDED|97.5|0.51|0.89||One-sided significance level = 0.0125|Log Rank||Reference level = PBRT + STAD|||0.89|0.51|<0.001
72617225|NCT00567580|144765958|SUPERIORITY||Hazard Ratio (HR)|0.39|||<|0.001|TWO_SIDED|97.5|0.3|0.51||One-sided significance level = 0.0125|Log Rank||Reference level = PBRT Alone|||0.51|0.30|<0.001
72617226|NCT00567580|144765959|SUPERIORITY||Hazard Ratio (HR)|0.73||||0.137|TWO_SIDED|97.5|0.39|1.39||One-sided significance level = 0.0125|Log Rank||Reference level = PBRT Alone|||1.39|0.39|0.137
72617227|NCT00567580|144765959|SUPERIORITY||Hazard Ratio (HR)|0.39||||0.007|TWO_SIDED|97.5|0.16|0.95||One-sided significance level = 0.0125|Log Rank||Reference level = PBRT + STAD|||0.95|0.16|0.007
72617228|NCT00567580|144765959|SUPERIORITY||Hazard Ratio (HR)|0.29|||<|0.001|TWO_SIDED|97.5|0.12|0.68||One-sided significance level = 0.0125|Log Rank||Reference level = PBRT Alone|||0.68|0.12|<0.001
72617229|NCT00567580|144765960|SUPERIORITY||Hazard Ratio (HR)|0.37||||0.01|TWO_SIDED|97.5|0.14|1.01||One-sided significance level = 0.0125|Log Rank||Reference level = PBRT Alone|||1.01|0.14|0.010
72617230|NCT00567580|144765960|SUPERIORITY||Hazard Ratio (HR)|0.56||||0.177|TWO_SIDED|97.5|0.14|2.3||One-sided significance level = 0.0125|Log Rank||Reference level = PBRT + STAD|||2.30|0.14|0.177
72617231|NCT00567580|144765960|SUPERIORITY||Hazard Ratio (HR)|0.21|||<|0.001|TWO_SIDED|97.5|0.06|0.71||One-sided significance level = 0.0125|Log Rank||Reference level = PBRT Alone|||0.71|0.06|<0.001
72617232|NCT00567580|144765961|SUPERIORITY||Hazard Ratio (HR)|0.78||||0.105|TWO_SIDED|97.5|0.49|1.22||One-sided significance level = 0.0125|Log Rank||Reference level = PBRT Alone|||1.22|0.49|0.105
72617233|NCT00567580|144765961|SUPERIORITY||Hazard Ratio (HR)|0.62||||0.022|TWO_SIDED|97.5|0.36|1.06||One-sided significance level = 0.0125|Log Rank||Reference level = PBRT + STAD|||1.06|0.36|0.022
72617234|NCT00567580|144765961|SUPERIORITY||Hazard Ratio (HR)|0.48|||<|0.001|TWO_SIDED|97.5|0.29|0.81||One-sided significance level = 0.0125|Log Rank||Reference level = PBRT Alone|||0.81|0.29|<0.001
72617235|NCT00567580|144765962|SUPERIORITY||Hazard Ratio (HR)|0.71||||0.137|TWO_SIDED|97.5|0.35|1.43||One-sided significance level = 0.0125|Log Rank||Reference level = PBRT Alone|||1.43|0.35|0.137
72371615|NCT00669409|144253449|SUPERIORITY_OR_OTHER_LEGACY||Least Mean Square Difference|4.6|STANDARD_ERROR_OF_MEAN|7.99|||TWO_SIDED|95.0|-11.2|20.4||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||20.4|-11.2|
72371616|NCT00669409|144253449|SUPERIORITY_OR_OTHER_LEGACY||Least Mean Square Difference|-4.7|STANDARD_ERROR_OF_MEAN|7.89|||TWO_SIDED|95.0|-20.3|10.9||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||10.9|-20.3|
72371617|NCT00669409|144253449|SUPERIORITY_OR_OTHER_LEGACY||Least Mean Square Difference|-4.1|STANDARD_ERROR_OF_MEAN|10.48|||TWO_SIDED|95.0|-24.9|16.6||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||16.6|-24.9|
72617236|NCT00567580|144765962|SUPERIORITY||Hazard Ratio (HR)|0.68||||0.141|TWO_SIDED|97.5|0.3|1.54||One-sided significance level = 0.0125|Log Rank||Reference level = PBRT + STAD|||1.54|0.30|0.141
72617237|NCT00567580|144765962|SUPERIORITY||Hazard Ratio (HR)|0.47||||0.014|TWO_SIDED|97.5|0.21|1.03||One-sided significance level = 0.0125|Log Rank||Reference level = PBRT Alone|||1.03|0.21|0.014
72617238|NCT00567580|144765963|SUPERIORITY||Hazard Ratio (HR)|0.86||||0.235|TWO_SIDED|97.5|0.54|1.38||One-sided significance level = 0.0125|Log Rank||Reference level = PBRT Alone|||1.38|0.54|0.235
72617239|NCT00567580|144765963|SUPERIORITY||Hazard Ratio (HR)|0.99||||0.481|TWO_SIDED|97.5|0.61|1.6||One-sided significance level = 0.0125|Log Rank||Reference level = PBRT + STAD|||1.60|0.61|0.481
72617240|NCT00567580|144765963|SUPERIORITY||Hazard Ratio (HR)|0.85||||0.213|TWO_SIDED|97.5|0.53|1.35||One-sided significance level = 0.0125|Log Rank||Reference level = PBRT Alone|||1.35|0.53|0.213
72617241|NCT00567580|144765964|SUPERIORITY||Odds Ratio (OR)|2.47|||<|0.001|TWO_SIDED|97.5|1.81|3.37||One-sided significance level = 0.025|Regression, Logistic|Model was adjusted for entry PSA level, pathology, seminal vesicle involvement, Gleason score, race, and age.|Reference level = PBRT Alone|Acute grade 2+ acute adverse events||3.37|1.81|<0.001
72617242|NCT00567580|144765964|SUPERIORITY||Odds Ratio (OR)|1.35||||0.007|TWO_SIDED|97.5|1.03|1.77||One-sided significance level = 0.025|Regression, Logistic|Model was adjusted for entry PSA level, pathology, seminal vesicle involvement, Gleason score, race, and age.|Reference level = PBRT + STAD|Acute grade 2+ acute adverse events||1.77|1.03|0.007
72617243|NCT00567580|144765964|SUPERIORITY||Odds Ratio (OR)|2.04||||0.002|TWO_SIDED|97.5|1.16|3.6||One-sided significance level = 0.025|Regression, Logistic|Univariate model was used due to the low number of events.|Reference level = PBRT Alone|Acute grade 3+ acute adverse events||3.60|1.16|0.002
72617244|NCT00567580|144765964|SUPERIORITY||Odds Ratio (OR)|1.47||||0.025|TWO_SIDED|95.0|0.975|2.27||One-sided significance level = 0.025|Regression, Logistic|Univariate model was used due to the low number of events.|Reference level = PBRT + STAD|Acute grade 3+ adverse events||2.27|0.975|0.025
72617245|NCT00567580|144765965|SUPERIORITY||Hazard Ratio (HR)|1.05||||0.268|TWO_SIDED|97.5|0.88|1.26||One-sided significance level = 0.025|Log Rank||Reference level = PBRT Alone|Late grade 2+ adverse events||1.26|0.88|0.268
72617246|NCT00567580|144765965|SUPERIORITY||Hazard Ratio (HR)|1.1||||0.101|TWO_SIDED|97.5|0.93|1.32||One-sided significance level = 0.025|Log Rank||Reference level = PBRT + STAD|Late grade 2+ adverse events||1.32|0.93|0.101
72617247|NCT00567580|144765965|SUPERIORITY||Hazard Ratio (HR)|1.22||||0.119|TWO_SIDED|97.5|0.83|1.8||One-sided significance level = 0.025|Log Rank||Reference level = PBRT Alone|Late grade 3+ adverse events||1.80|0.83|0.119
72617248|NCT00567580|144765965|SUPERIORITY||Hazard Ratio (HR)|1.16||||0.17|TWO_SIDED|97.5|0.82|1.65||One-sided significance level = 0.025|Log Rank||Reference level = PBRT + STAD|Late grade 3+ adverse events||1.65|0.82|0.170
72617249|NCT02357485|144765991|SUPERIORITY_OR_OTHER||||||<|0.004|TWO_SIDED|||||Baseline vs 1 year Post-treatment|t-test, 2 sided|||||||<0.004
72617250|NCT02357485|144765992|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Baseline vs 1 year Post-treatment|t-test, 2 sided|||||||<0.001
72617251|NCT02357485|144765993|SUPERIORITY_OR_OTHER|||||||0.053|TWO_SIDED||||||t-test, 2 sided|||||||0.053
72617252|NCT02357485|144765994|SUPERIORITY_OR_OTHER|||||||0.003|TWO_SIDED||||||t-test, 2 sided|||||||0.003
72617253|NCT02802865|144766011|SUPERIORITY||Rate ratio|1.8||||0.007|TWO_SIDED|95.0|1.18|2.75|||Chi-squared, Corrected|||||2.75|1.18|0.007
72617254|NCT02802865|144766012|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
72617255|NCT02802865|144766013|SUPERIORITY|||||||0.004|||||||Wilcoxon (Mann-Whitney)|||||||0.004
72617256|NCT02802865|144766014|SUPERIORITY|||||||0.006|||||||t-test, 2 sided|||||||0.006
72617257|NCT02802865|144766015|SUPERIORITY|||||||0.709|||||||Chi-squared|||This study was not powered to detect significant between-group differences for this conception.||||0.709
72617258|NCT02802865|144766016|SUPERIORITY|||||||0.356|||||||Chi-squared|||This study was not powered to detect significant between-group differences for clinical pregnancy.||||0.356
72617259|NCT02802865|144766018|SUPERIORITY|||||||0.356|||||||Chi-squared|||This study was not powered to detect significant between-group differences for live birth.||||0.356
72617260|NCT02802865|144766019|SUPERIORITY|||||||0.486|||||||Chi-squared, Corrected|||This study was not powered to detect significant between-group differences for pregnancy loss.||||0.486
72617261|NCT01454063|144766022|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.577|STANDARD_ERROR_OF_MEAN|0.052|<|0.0001||95.0|0.475|0.678||p-value based on the generalized Cochran-Mantel-Haenszel (CMH) test stratified by randomization strata.|Cochran-Mantel-Haenszel|CMH-weighted mean difference (OMS - Placebo) adjusted for randomization strata.||||0.678|0.475|<0.0001
72617262|NCT01454063|144766023|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.199|STANDARD_ERROR_OF_MEAN|1.076|<|0.0001||95.0|-7.307|-3.091||p-value based on the generalized CMH test stratified by randomization strata.|Cochran-Mantel-Haenszel|CMH-weighted mean difference (OMS302-placebo) adjusted for randomization strata.||||-3.091|-7.307|<0.0001
72617263|NCT01454063|144766024|SUPERIORITY_OR_OTHER|||||||0.0514||||||Treatment comparisons based on CMH test adjusting for randomization strata.|Cochran-Mantel-Haenszel|||||||0.0514
72617264|NCT01454063|144766025|SUPERIORITY_OR_OTHER|||||||0.0034||||||Treatment comparisons based on CMH test adjusting for the randomization strata.|Cochran-Mantel-Haenszel|||||||0.0034
72617265|NCT01454063|144766026|SUPERIORITY_OR_OTHER|||||||0.0963||||||Treatment comparisons based on Wilcoxon rank-sum test stratified by randomization strata. For subjects without a score due to inability to read the ETDRS chart, the log score will be imputed as 1.6 for the purpose of treatment comparisons.|Wilcoxon rank-sum test|||||||0.0963
72617266|NCT01454063|144766027|SUPERIORITY_OR_OTHER|||||||0.0532||||||Treatment comparisons are based on generalized CMH test stratified by randomization strata.|Cochran-Mantel-Haenszel|||||||0.0532
72617267|NCT01454063|144766028|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Generalized CMH test stratified by randomization strata.|Cochran-Mantel-Haenszel|||||||<0.0001
72617268|NCT02391584|144766029|SUPERIORITY||||||<|0.0001||||||p\<0.025 was considered significant.|t-test, 1 sided|||||||<0.0001
72617269|NCT02391584|144766033|SUPERIORITY||||||<|0.0001||||||Dunnett's t-test was used for the multiple comparisons with baseline. A p value \<0.05 was considered significant.|Mixed Models Analysis|||||||<0.0001
72617270|NCT02391584|144766034|SUPERIORITY||||||<|0.0001||||||Dunnett's t-test was used for the multiple comparisons with baseline. A p value \<0.05 was considered significant.|Mixed Models Analysis|||||||<0.0001
72617271|NCT02391584|144766035|SUPERIORITY||||||<|0.0001||||||Dunnett's t-test was used for the multiple comparisons with baseline. A p value \<0.05 was considered significant.|Mixed Models Analysis|||||||<0.0001
72617272|NCT02391584|144766036|SUPERIORITY||||||<|0.0001||||||Dunnett's t-test was used for the multiple comparisons with baseline. A p value \<0.05 was considered significant.|Mixed Models Analysis|||||||<0.0001
72617273|NCT00710554|144766038|SUPERIORITY_OR_OTHER_LEGACY||estimated mean treatment difference|-0.34||||0.139|TWO_SIDED|95.0|-0.79|0.11|||ANCOVA|||The model used for the analysis of the end of study value was an analysis of covariance (ANCOVA) with baseline value as a covariate and treatment group and centre group as main effect. Due to the low power of the test for interaction, the test was performed at the 10% significance level as a possible indicator of an interactive effect. The null hypothesis was one of no difference between treatments.||0.11|-0.79|0.139
72617274|NCT00710554|144766039|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-2.86||||0.198|TWO_SIDED|95.0|-7.22|1.5|||ANCOVA|||The change from baseline in mean Neuropathic Pain Scale score was compared between treatment groups and centres using ANCOVA. The model was to include treatment and centre group as factors and baseline mean usage as a covariate.||1.50|-7.22|0.198
72617275|NCT00710554|144766040|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-0.83||||0.007|TWO_SIDED|95.0|-1.43|-0.23|||ANCOVA|||The change from baseline score was compared between treatment groups and centres using ANCOVA. The model was to include treatment and centre group as factors and baseline mean usage as a covariate.||-0.23|-1.43|0.007
72617276|NCT00710554|144766041|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|0.08||||0.795|TWO_SIDED|95.0|-0.52|0.68|||ANCOVA|||The change in the dynamic allodynia pain score from baseline to the end of treatment was analysed using ANCOVA with the baseline value as a covariate and country and treatment group as factors.||0.68|-0.52|0.795
72617277|NCT00710554|144766042|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-0.14||||0.233|TWO_SIDED|95.0|-0.37|0.09|||ANCOVA|||The change in the punctate allodynia pain threshold force from baseline to the end of treatment was analysed using ANCOVA with the baseline value as a covariate and country and treatment group as factors.||0.09|-0.37|0.233
72617278|NCT00710554|144766043|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.762||||0.023|TWO_SIDED|95.0|1.08|2.88|||Regression, Logistic|||The two treatment groups were compared using ordinal logistic regression and the proportional odds model. The initial model incorporated treatment and centre group as factors. The odds ratio together with its 95% CI and associated p-value are presented.||2.88|1.08|0.023
72617279|NCT00710554|144766044|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-0.25||||0.288|TWO_SIDED|95.0|-0.72|0.21|||ANCOVA|||The change from baseline in mean Brief Pain Inventory (short form) score was compared between treatment groups and centres using ANCOVA. The model was to include treatment and centre group as factors and baseline mean usage as a covariate.||0.21|-0.72|0.288
72617280|NCT00710554|144766045|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-0.01||||0.617|TWO_SIDED|95.0|-0.06|0.04|||ANCOVA|||The change from baseline in mean EuroQol-5D score was compared between treatment groups and centres using ANCOVA. The model included treatment and centre groups as factors and baseline mean usage as a covariate.||0.04|-0.06|0.617
72617281|NCT00710554|144766046|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-0.75|STANDARD_ERROR_OF_MEAN|2.459||0.76|TWO_SIDED|95.0|-5.6|4.09|||ANCOVA|||The change from baseline in mean EuroQol-5D score was compared between treatment groups and centres using ANCOVA. The model included treatment and centre groups as factors and baseline mean usage as a covariate.||4.09|-5.60|0.76
72617282|NCT00710554|144766047|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-0.38||||0.112|TWO_SIDED|95.0|-0.85|0.09|||ANCOVA|||The model used for the analysis of the end of study value was an ANCOVA with baseline value as a covariate and treatment group and centre group as main effect. The null hypothesis was one of no difference between treatments.||0.09|-0.85|0.112
72617283|NCT04053452|144766058|OTHER||Area under the curve|0.7262|||||TWO_SIDED||||||||Area under the receiver operating characteristic (ROC) curve.|||||
72617284|NCT04053452|144766059|OTHER||Area under the curve|0.6667|||||TWO_SIDED||||||||Area under the receiver operating characteristic (ROC) curve.|||||
72617285|NCT04053452|144766060|OTHER||Area under the curve|0.7083|||||TWO_SIDED||||||||Area under the receiver operating characteristic (ROC) curve.|||||
72617286|NCT04053452|144766061|OTHER|Median at wrist|Kendall's tau correlation coefficient|-0.0623|||||TWO_SIDED|95.0|-0.5005|0.4791||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and length of hospital stay.||0.4791|-0.5005|
72617287|NCT04053452|144766061|OTHER|Median at forearm|Kendall's tau correlation coefficient|-0.1628|||||TWO_SIDED|95.0|-0.6503|0.4222||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and length of hospital stay.||0.4222|-0.6503|
72617288|NCT04053452|144766061|OTHER|Median at cubital fossa|Kendall's tau correlation coefficient|-0.185|||||TWO_SIDED|95.0|-0.549|0.1829||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and length of hospital stay.||0.1829|-0.5490|
72617289|NCT04053452|144766061|OTHER|Median at humerus|Kendall's tau correlation coefficient|0.0512|||||TWO_SIDED|95.0|-0.3411|0.5017||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and length of hospital stay.||0.5017|-0.3411|
72617290|NCT04053452|144766061|OTHER|Median at axilla|Kendall's tau correlation coefficient|0.0476|||||TWO_SIDED|95.0|-0.4335|0.5592||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and length of hospital stay.||0.5592|-0.4335|
72617291|NCT04053452|144766061|OTHER|Ulnar at wrist|Kendall's tau correlation coefficient|-0.1229|||||TWO_SIDED|95.0|-0.5092|0.304||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and length of hospital stay.||0.3040|-0.5092|
72617292|NCT04053452|144766061|OTHER|Ulnar at forearm|Kendall's tau correlation coefficient|0.0603|||||TWO_SIDED|95.0|-0.3057|0.4137||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and length of hospital stay.||0.4137|-0.3057|
72617293|NCT04053452|144766061|OTHER|Ulnar at cubital fossa|Kendall's tau correlation coefficient|0.1059|||||TWO_SIDED|95.0|-0.4028|0.57||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and length of hospital stay.||0.5700|-0.4028|
72617294|NCT04053452|144766061|OTHER|Ulnar at humerus|Kendall's tau correlation coefficient|-0.1786|||||TWO_SIDED|95.0|-0.6503|0.2838||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and length of hospital stay.||0.2838|-0.6503|
72617295|NCT04053452|144766061|OTHER|Ulnar at axilla|Kendall's tau correlation coefficient|-0.2396|||||TWO_SIDED|95.0|-0.5714|0.195||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and length of hospital stay.||0.1950|-0.5714|
72617296|NCT04053452|144766061|OTHER|C6|Kendall's tau correlation coefficient|-0.0671|||||TWO_SIDED|95.0|-0.4667|0.3336||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and length of hospital stay.||0.3336|-0.4667|
72617297|NCT04053452|144766061|OTHER|C7|Kendall's tau correlation coefficient|-0.2134|||||TWO_SIDED|95.0|-0.7018|0.3193||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and length of hospital stay.||0.3193|-0.7018|
72617298|NCT04053452|144766061|OTHER|Vagus|Kendall's tau correlation coefficient|0.0246|||||TWO_SIDED|95.0|-0.3506|0.4596||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and length of hospital stay.||0.4596|-0.3506|
72617299|NCT04053452|144766062|OTHER|Median at wrist|Odds Ratio (OR)|0.7686494||||0.36|TWO_SIDED||||||Regression, Logistic|||Null hypothesis: Nerve ultrasound measurement has no effect on the log-odds of walking (i.e., nerve ultrasound measurements do not predict whether a subject is ambulatory at discharge).||||0.360
72617300|NCT04053452|144766062|OTHER|Median at forearm|Odds Ratio (OR)|0.9315228||||0.521|TWO_SIDED||||||Regression, Logistic|||Null hypothesis: Nerve ultrasound measurement has no effect on the log-odds of walking (i.e., nerve ultrasound measurements do not predict whether a subject is ambulatory at discharge).||||0.521
72617301|NCT04053452|144766062|OTHER|Median at cubital fossa|Odds Ratio (OR)|0.7949528||||0.245|TWO_SIDED||||||Regression, Logistic|||Null hypothesis: Nerve ultrasound measurement has no effect on the log-odds of walking (i.e., nerve ultrasound measurements do not predict whether a subject is ambulatory at discharge).||||0.245
72617302|NCT04053452|144766062|OTHER|Median at humerus|Odds Ratio (OR)|0.8603349||||0.541|TWO_SIDED||||||Regression, Logistic|||Null hypothesis: Nerve ultrasound measurement has no effect on the log-odds of walking (i.e., nerve ultrasound measurements do not predict whether a subject is ambulatory at discharge).||||0.541
72555085|NCT03086460|144641773|SUPERIORITY||Mean Difference (Final Values)|-0.027||||0.493|TWO_SIDED|95.0|-0.104|0.051|||ANCOVA|||"Day 14~Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment B (CHF 1531 pMDI 12 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.051|-0.104|0.493
72555086|NCT03086460|144641773|SUPERIORITY||Mean Difference (Final Values)|0.019||||0.616|TWO_SIDED|95.0|-0.055|0.092|||ANCOVA|||"Day 14~Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment B (CHF 1531 pMDI 12 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.092|-0.055|0.616
72555087|NCT03086460|144641773|SUPERIORITY||Mean Difference (Final Values)|0.046||||0.212|TWO_SIDED|95.0|-0.026|0.118|||ANCOVA|||"Day 14~Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment C (CHF 1531 pMDI 24 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.118|-0.026|0.212
72555088|NCT03086460|144641774|SUPERIORITY||Mean Difference (Final Values)|0.034||||0.361|TWO_SIDED|95.0|-0.039|0.106|||ANCOVA|||"Day 1~Comparison groups were:~Treatment A (CHF 1531 pMDI 6 μg TDD) versus Treatment E (Placebo).~This secondary efficacy variable was analyzed using the ANCOVA model that was also used for the primary efficacy analysis, without adjusting for multiplicity."||0.106|-0.039|0.361
72555089|NCT03086460|144641774|SUPERIORITY||Mean Difference (Final Values)|0.065||||0.085|TWO_SIDED|95.0|-0.009|0.138|||ANCOVA|||"Day 1~Comparison groups were:~Treatment B (CHF 1531 pMDI 12 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.138|-0.009|0.085
72555090|NCT03086460|144641774|SUPERIORITY||Mean Difference (Final Values)|0.036||||0.328|TWO_SIDED|95.0|-0.037|0.109|||ANCOVA|||"Day 1~Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.109|-0.037|0.328
72555091|NCT03086460|144641774|SUPERIORITY||Mean Difference (Final Values)|0.112||||0.002|TWO_SIDED|95.0|0.042|0.182|||ANCOVA|||"Day 1~Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.182|0.042|0.002
72555092|NCT03086460|144641774|SUPERIORITY||Mean Difference (Final Values)|0.089||||0.011|TWO_SIDED|95.0|0.02|0.158|||ANCOVA|||"Day 1~Comparison groups were:~Treatment F ( Perforomist® IS 40 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.158|0.020|0.011
72555093|NCT03086460|144641774|SUPERIORITY||Mean Difference (Final Values)|0.031||||0.404|TWO_SIDED|95.0|-0.042|0.104|||ANCOVA|||"Day 1~Comparison groups were:~Treatment B (CHF 1531 pMDI 12 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.104|-0.042|0.404
72555094|NCT03086460|144641774|SUPERIORITY||Mean Difference (Final Values)|0.003||||0.942|TWO_SIDED|95.0|-0.069|0.074|||ANCOVA|||"Day 1~Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.074|-0.069|0.942
72555095|NCT03086460|144641774|SUPERIORITY||Mean Difference (Final Values)|0.078||||0.027|TWO_SIDED|95.0|0.009|0.147|||ANCOVA|||"Day 1~Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.147|0.009|0.027
72555096|NCT03086460|144641774|SUPERIORITY||Mean Difference (Final Values)|-0.028||||0.463|TWO_SIDED|95.0|-0.104|0.048|||ANCOVA|||"Day 1~Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment B (CHF 1531 pMDI 12 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.048|-0.104|0.463
72617303|NCT04053452|144766062|OTHER|Median at axilla|Odds Ratio (OR)|0.8767973||||0.415|TWO_SIDED||||||Regression, Logistic|||Null hypothesis: Nerve ultrasound measurement has no effect on the log-odds of walking (i.e., nerve ultrasound measurements do not predict whether a subject is ambulatory at discharge).||||0.415
72617304|NCT04053452|144766062|OTHER|Ulnar at wrist|Odds Ratio, log|0.7613965||||0.504|TWO_SIDED||||||Regression, Logistic|||Null hypothesis: Nerve ultrasound measurement has no effect on the log-odds of walking (i.e., nerve ultrasound measurements do not predict whether a subject is ambulatory at discharge).||||0.504
72617305|NCT04053452|144766062|OTHER|Ulnar at forearm|Odds Ratio (OR)|0.8061505||||0.393|TWO_SIDED||||||Regression, Logistic|||Null hypothesis: Nerve ultrasound measurement has no effect on the log-odds of walking (i.e., nerve ultrasound measurements do not predict whether a subject is ambulatory at discharge).||||0.393
72617306|NCT04053452|144766062|OTHER|Ulnar at cubital fossa|Odds Ratio (OR)|0.8336885||||0.222|TWO_SIDED||||||Regression, Logistic|||Null hypothesis: Nerve ultrasound measurement has no effect on the log-odds of walking (i.e., nerve ultrasound measurements do not predict whether a subject is ambulatory at discharge).||||0.222
72617307|NCT04053452|144766062|OTHER|Ulnar at humerus|Odds Ratio (OR)|1.1214848||||0.615|TWO_SIDED||||||Regression, Logistic|||Null hypothesis: Nerve ultrasound measurement has no effect on the log-odds of walking (i.e., nerve ultrasound measurements do not predict whether a subject is ambulatory at discharge).||||0.615
72617308|NCT04053452|144766062|OTHER|Ulnar at axilla|Odds Ratio (OR)|0.9898411||||0.926|TWO_SIDED||||||Regression, Logistic|||Null hypothesis: Nerve ultrasound measurement has no effect on the log-odds of walking (i.e., nerve ultrasound measurements do not predict whether a subject is ambulatory at discharge).||||0.926
72617309|NCT04053452|144766062|OTHER|C6|Odds Ratio (OR)|0.9402829||||0.519|TWO_SIDED||||||Regression, Logistic|||Null hypothesis: Nerve ultrasound measurement has no effect on the log-odds of walking (i.e., nerve ultrasound measurements do not predict whether a subject is ambulatory at discharge).||||0.519
72617310|NCT04053452|144766062|OTHER|C7|Odds Ratio (OR)|0.9347906||||0.379|TWO_SIDED||||||Regression, Logistic|||Null hypothesis: Nerve ultrasound measurement has no effect on the log-odds of walking (i.e., nerve ultrasound measurements do not predict whether a subject is ambulatory at discharge).||||0.379
72617311|NCT04053452|144766062|OTHER|Vagus|Odds Ratio (OR)|0.8968658||||0.511|TWO_SIDED||||||Regression, Logistic|||Null hypothesis: Nerve ultrasound measurement has no effect on the log-odds of walking (i.e., nerve ultrasound measurements do not predict whether a subject is ambulatory at discharge).||||0.511
72617312|NCT04053452|144766063|OTHER|Median at wrist|Kendall's tau correlation coefficient|-0.057735|||||TWO_SIDED|95.0|-0.4273|0.3293||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and respiratory dysfunction.||0.3293|-0.4273|
72617313|NCT04053452|144766063|OTHER|Median at forearm|Kendall's tau correlation coefficient|-0.0359442|||||TWO_SIDED|95.0|-0.548|0.5248||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and respiratory dysfunction.||0.5248|-0.5480|
72617314|NCT04053452|144766063|OTHER|Median at cubital fossa|Kendall's tau correlation coefficient|0.1429483|||||TWO_SIDED|95.0|-0.1938|0.4763||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and respiratory dysfunction.||0.4763|-0.1938|
72617315|NCT04053452|144766063|OTHER|Median at humerus|Kendall's tau correlation coefficient|-0.3955939|||||TWO_SIDED|95.0|-0.6811|-0.0874||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and respiratory dysfunction.||-0.0874|-0.6811|
72617316|NCT04053452|144766063|OTHER|Median at axilla|Kendall's tau correlation coefficient|-0.3681051|||||TWO_SIDED|95.0|-0.7032|0.1185||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and respiratory dysfunction.||0.1185|-0.7032|
72617317|NCT04053452|144766063|OTHER|Ulnar at wrist|Kendall's tau correlation coefficient|-0.4938292|||||TWO_SIDED|95.0|-0.7112|-0.1978||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and respiratory dysfunction.||-0.1978|-0.7112|
72617318|NCT04053452|144766063|OTHER|Ulnar at forearm|Kendall's tau correlation coefficient|0.1304373|||||TWO_SIDED|95.0|-0.2201|0.5014||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and respiratory dysfunction.||0.5014|-0.2201|
72617319|NCT04053452|144766063|OTHER|Ulnar at cubital fossa|Kendall's tau correlation coefficient|0.3273268|||||TWO_SIDED|95.0|-0.0679|0.6612||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and respiratory dysfunction.||0.6612|-0.0679|
72617320|NCT04053452|144766063|OTHER|Ulnar at humerus|Kendall's tau correlation coefficient|-0.0552157|||||TWO_SIDED|95.0|-0.4213|0.361||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and respiratory dysfunction.||0.3610|-0.4213|
72617321|NCT04053452|144766063|OTHER|Ulnar at axilla|Kendall's tau correlation coefficient|-0.1666667|||||TWO_SIDED|95.0|-0.5389|0.2057||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and respiratory dysfunction.||0.2057|-0.5389|
72617322|NCT04053452|144766063|OTHER|C6|Kendall's tau correlation coefficient|-0.3194892|||||TWO_SIDED|95.0|-0.6539|0.2288||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and respiratory dysfunction.||0.2288|-0.6539|
72617323|NCT04053452|144766063|OTHER|C7|Kendall's tau correlation coefficient|-0.4959498|||||TWO_SIDED|95.0|-0.686|-0.2065||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and respiratory dysfunction.||-0.2065|-0.6860|
72617324|NCT04053452|144766063|OTHER|Vagus|Kendall's tau correlation coefficient|-0.3228883|||||TWO_SIDED|95.0|-0.6487|0.0||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and respiratory dysfunction.||0.0000|-0.6487|
72617325|NCT04053452|144766064|OTHER|Median at wrist|Kendall's tau correlation coefficient|-0.1415346|||||TWO_SIDED|95.0|-0.735|0.4247||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and strength by hand dynamometer.||0.4247|-0.7350|
72617326|NCT04053452|144766064|OTHER|Median at forearm|Kendall's tau correlation coefficient|0.1987845|||||TWO_SIDED|95.0|-0.4377|0.8004||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and strength by hand dynamometer.||0.8004|-0.4377|
72617327|NCT04053452|144766064|OTHER|Median at cubital fossa|Kendall's tau correlation coefficient|-0.0789747|||||TWO_SIDED|95.0|-0.5256|0.3778||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and strength by hand dynamometer.||0.3778|-0.5256|
72617328|NCT04053452|144766064|OTHER|Median at humerus|Kendall's tau correlation coefficient|0.1621509|||||TWO_SIDED|95.0|-0.3591|0.5606||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and strength by hand dynamometer.||0.5606|-0.3591|
72617329|NCT04053452|144766064|OTHER|Median at axilla|Kendall's tau correlation coefficient|0.1499412|||||TWO_SIDED|95.0|-0.3901|0.6374||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and strength by hand dynamometer.||0.6374|-0.3901|
72617330|NCT04053452|144766064|OTHER|Ulnar at wrist|Kendall's tau correlation coefficient|-0.0140441|||||TWO_SIDED|95.0|-0.5773|0.5407||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and strength by hand dynamometer.||0.5407|-0.5773|
72617331|NCT04053452|144766064|OTHER|Ulnar at forearm|Kendall's tau correlation coefficient|0.01383297|||||TWO_SIDED|95.0|-0.5288|0.5485||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and strength by hand dynamometer.||0.5485|-0.5288|
72617332|NCT04053452|144766064|OTHER|Ulnar at cubital fossa|Kendall's tau correlation coefficient|-0.2935683|||||TWO_SIDED|95.0|-0.6968|0.2414||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and strength by hand dynamometer.||0.2414|-0.6968|
72617333|NCT04053452|144766064|OTHER|Ulnar at humerus|Kendall's tau correlation coefficient|0.1067521|||||TWO_SIDED|95.0|-0.5204|0.6392||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and strength by hand dynamometer.||0.6392|-0.5204|
72617334|NCT04053452|144766064|OTHER|Ulnar at axilla|Kendall's tau correlation coefficient|0.0549235|||||TWO_SIDED|95.0|-0.4633|0.5594||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and strength by hand dynamometer.||0.5594|-0.4633|
72617335|NCT04053452|144766064|OTHER|C6|Kendall's tau correlation coefficient|-0.2597622|||||TWO_SIDED|95.0|-0.6816|0.1857||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and strength by hand dynamometer.||0.1857|-0.6816|
72617336|NCT04053452|144766064|OTHER|C7|Kendall's tau correlation coefficient|-0.0129034|||||TWO_SIDED|95.0|-0.4476|0.4025||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and strength by hand dynamometer.||0.4025|-0.4476|
72617337|NCT04053452|144766064|OTHER|Vagus|Kendall's tau correlation coefficient|0.02457737|||||TWO_SIDED|95.0|-0.3506|0.4596||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and strength by hand dynamometer.||0.4596|-0.3506|
72617338|NCT04053452|144766065|OTHER|Median at wrist|Kendall's tau correlation coefficient|0.1704986|||||TWO_SIDED|95.0|-0.395|0.6584||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and strength by MRC sum score.||0.6584|-0.3950|
72617339|NCT04053452|144766065|OTHER|Median at forearm|Kendall's tau correlation coefficient|0.1704986|||||TWO_SIDED|95.0|-0.395|0.6584||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and strength by MRC sum score.||0.6584|-0.3950|
72617340|NCT04053452|144766065|OTHER|Median at cubital fossa|Kendall's tau correlation coefficient|0.09040847|||||TWO_SIDED|95.0|-0.3821|0.5979||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and strength by MRC sum score.||0.5979|-0.3821|
72617341|NCT04053452|144766065|OTHER|Median at humerus|Kendall's tau correlation coefficient|0.02501955|||||TWO_SIDED|95.0|-0.4158|0.479||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and strength by MRC sum score.||0.4790|-0.4158|
72617342|NCT04053452|144766065|OTHER|Median at axilla|Kendall's tau correlation coefficient|-0.0349215|||||TWO_SIDED|95.0|-0.5033|0.443||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and strength by MRC sum score.||0.4430|-0.5033|
72617343|NCT04053452|144766065|OTHER|Ulnar at wrist|Kendall's tau correlation coefficient|-0.0961|||||TWO_SIDED|95.0|-0.5458|0.4037||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and strength by MRC sum score.||0.4037|-0.5458|
72617344|NCT04053452|144766065|OTHER|Ulnar at forearm|Kendall's tau correlation coefficient|-0.2239171|||||TWO_SIDED|95.0|-0.6514|0.2935||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and strength by MRC sum score.||0.2935|-0.6514|
72617345|NCT04053452|144766065|OTHER|Ulnar at cubital fossa|Kendall's tau correlation coefficient|-0.0805076|||||TWO_SIDED|95.0|-0.5371|0.2974||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and strength by MRC sum score.||0.2974|-0.5371|
72617346|NCT04053452|144766065|OTHER|Ulnar at humerus|Kendall's tau correlation coefficient|0.2910126|||||TWO_SIDED|95.0|-0.2791|0.7651||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and strength by MRC sum score.||0.7651|-0.2791|
72617347|NCT04053452|144766065|OTHER|Ulnar at axilla|Kendall's tau correlation coefficient|0.02342428|||||TWO_SIDED|95.0|-0.4531|0.5267||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and strength by MRC sum score.||0.5267|-0.4531|
72617348|NCT04053452|144766065|OTHER|C6|Kendall's tau correlation coefficient|0.06536087|||||TWO_SIDED|95.0|-0.2786|0.4454||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and strength by MRC sum score.||0.4454|-0.2786|
72617349|NCT04053452|144766065|OTHER|C7|Kendall's tau correlation coefficient|0.2207792|||||TWO_SIDED|95.0|-0.2459|0.6708||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and strength by MRC sum score.||0.6708|-0.2459|
72617350|NCT04053452|144766065|OTHER|Vagus|Kendall's tau correlation coefficient|0.14415|||||TWO_SIDED|95.0|-0.2333|0.4899||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and strength by MRC sum score.||0.4899|-0.2333|
72617351|NCT04053452|144766066|OTHER|Median at wrist|Odds Ratio (OR)|0.9310743||||0.548|TWO_SIDED||||||Regression, Logistic|||Null hypothesis: Nerve ultrasound measurement has no effect on the log-odds of having autonomic dysfunction (i.e., higher ultrasound measurements do not predict whether a subject has autonomic dysfunction during their hospitalization).||||0.548
72617352|NCT04053452|144766066|OTHER|Median at forearm|Odds Ratio (OR)|0.9310743||||0.548|TWO_SIDED||||||Regression, Logistic|||Null hypothesis: Nerve ultrasound measurement has no effect on the log-odds of having autonomic dysfunction (i.e., higher ultrasound measurements do not predict whether a subject has autonomic dysfunction during their hospitalization).||||0.548
72617353|NCT04053452|144766066|OTHER|Median at cubital fossa|Odds Ratio (OR)|1.23944918||||0.25|TWO_SIDED||||||Regression, Logistic|||Null hypothesis: Nerve ultrasound measurement has no effect on the log-odds of having autonomic dysfunction (i.e., higher ultrasound measurements do not predict whether a subject has autonomic dysfunction during their hospitalization).||||0.250
72617354|NCT04053452|144766066|OTHER|Median at humerus|Odds Ratio (OR)|0.9613236||||0.874|TWO_SIDED||||||Regression, Logistic|||Null hypothesis: Nerve ultrasound measurement has no effect on the log-odds of having autonomic dysfunction (i.e., higher ultrasound measurements do not predict whether a subject has autonomic dysfunction during their hospitalization).||||0.874
72617355|NCT04053452|144766066|OTHER|Median at axilla|Odds Ratio (OR)|0.9442314||||0.698|TWO_SIDED|95.0|||||Regression, Logistic|||Null hypothesis: Nerve ultrasound measurement has no effect on the log-odds of having autonomic dysfunction (i.e., higher ultrasound measurements do not predict whether a subject has autonomic dysfunction during their hospitalization).||||0.698
72617356|NCT04053452|144766066|OTHER|Ulnar at wrist|Odds Ratio (OR)|1.193941||||0.665|TWO_SIDED||||||Regression, Logistic|||Null hypothesis: Nerve ultrasound measurement has no effect on the log-odds of having autonomic dysfunction (i.e., higher ultrasound measurements do not predict whether a subject has autonomic dysfunction during their hospitalization).||||0.665
72617357|NCT04053452|144766066|OTHER|Ulnar at forearm|Odds Ratio (OR)|1.0524489||||0.82|TWO_SIDED||||||Regression, Logistic|||Null hypothesis: Nerve ultrasound measurement has no effect on the log-odds of having autonomic dysfunction (i.e., higher ultrasound measurements do not predict whether a subject has autonomic dysfunction during their hospitalization).||||0.820
72617358|NCT04053452|144766066|OTHER|Ulnar at cubital fossa|Odds Ratio (OR)|1.21669122||||0.193|TWO_SIDED||||||Regression, Logistic|||Null hypothesis: Nerve ultrasound measurement has no effect on the log-odds of having autonomic dysfunction (i.e., higher ultrasound measurements do not predict whether a subject has autonomic dysfunction during their hospitalization).||||0.193
72617359|NCT04053452|144766066|OTHER|Ulnar at humerus|Odds Ratio (OR)|1.2994068||||0.314|TWO_SIDED||||||Regression, Logistic|||Null hypothesis: Nerve ultrasound measurement has no effect on the log-odds of having autonomic dysfunction (i.e., higher ultrasound measurements do not predict whether a subject has autonomic dysfunction during their hospitalization).||||0.314
72617360|NCT04053452|144766066|OTHER|Ulnar at axilla|Odds Ratio (OR)|1.1015629||||0.405|TWO_SIDED||||||Regression, Logistic|||Null hypothesis: Nerve ultrasound measurement has no effect on the log-odds of having autonomic dysfunction (i.e., higher ultrasound measurements do not predict whether a subject has autonomic dysfunction during their hospitalization).||||0.405
72617361|NCT04053452|144766066|OTHER|C6|Odds Ratio (OR)|0.9140133||||0.389|TWO_SIDED||||||Regression, Logistic|||Null hypothesis: Nerve ultrasound measurement has no effect on the log-odds of having autonomic dysfunction (i.e., higher ultrasound measurements do not predict whether a subject has autonomic dysfunction during their hospitalization).||||0.389
72617362|NCT04053452|144766066|OTHER|C7|Odds Ratio (OR)|0.7982946||||0.139|TWO_SIDED||||||Regression, Logistic|||Null hypothesis: Nerve ultrasound measurement has no effect on the log-odds of having autonomic dysfunction (i.e., higher ultrasound measurements do not predict whether a subject has autonomic dysfunction during their hospitalization).||||0.139
72617363|NCT04053452|144766066|OTHER|Vagus|Odds Ratio (OR)|0.9330042||||0.622|TWO_SIDED||||||Regression, Logistic|||Null hypothesis: Nerve ultrasound measurement has no effect on the log-odds of having autonomic dysfunction (i.e., higher ultrasound measurements do not predict whether a subject has autonomic dysfunction during their hospitalization).||||0.622
72617364|NCT04053452|144766067|OTHER|Median at wrist, 3 months|Kendall's tau correlation coefficient|0.2641183|||||TWO_SIDED|95.0|-0.2344|0.7511||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and GBS Disability score at 3 months after enrollment.||0.7511|-0.2344|
72617365|NCT04053452|144766067|OTHER|Median at forearm, 3 months|Kendall's tau correlation coefficient|0.02596308|||||TWO_SIDED|95.0|-0.4859|0.5555||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and GBS Disability score at 3 months after enrollment.||0.5555|-0.4859|
72617366|NCT04053452|144766067|OTHER|Median at cubital fossa, 3 months|Kendall's tau correlation coefficient|0.05162687|||||TWO_SIDED|95.0|-0.3342|0.417||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and GBS Disability score at 3 months after enrollment.||0.4170|-0.3342|
72617367|NCT04053452|144766067|OTHER|Median at humerus, 3 months|Kendall's tau correlation coefficient|-0.1714461|||||TWO_SIDED|95.0|-0.6473|0.2723||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and GBS Disability score at 3 months after enrollment.||0.2723|-0.6473|
72617368|NCT04053452|144766067|OTHER|Median at axilla, 3 months|Kendall's tau correlation coefficient|-0.0531775|||||TWO_SIDED|95.0|-0.583|0.4451||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and GBS Disability score at 3 months after enrollment.||0.4451|-0.5830|
72617369|NCT04053452|144766067|OTHER|Ulnar at wrist, 3 months|Kendall's tau correlation coefficient|0.1371924|||||TWO_SIDED|95.0|-0.3592|0.6944||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and GBS Disability score at 3 months after enrollment.||0.6944|-0.3592|
72617370|NCT04053452|144766067|OTHER|Ulnar at forearm, 3 months|Kendall's tau correlation coefficient|-0.0134595|||||TWO_SIDED|95.0|-0.5145|0.4627||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and GBS Disability score at 3 months after enrollment.||0.4627|-0.5145|
72617371|NCT04053452|144766067|OTHER|Ulnar at cubital fossa, 3 months|Kendall's tau correlation coefficient|0.01313517|||||TWO_SIDED|95.0|-0.5056|0.4833||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and GBS Disability score at 3 months after enrollment.||0.4833|-0.5056|
72617372|NCT04053452|144766067|OTHER|Ulnar at humerus, 3 months|Kendall's tau correlation coefficient|-0.1196495|||||TWO_SIDED|95.0|-0.5876|0.3467||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and GBS Disability score at 3 months after enrollment.||0.3467|-0.5876|
72617373|NCT04053452|144766067|OTHER|Ulnar at axilla, 3 months|Kendall's tau correlation coefficient|0.0|||||TWO_SIDED|95.0|-0.3682|0.3885||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and GBS Disability score at 3 months after enrollment.||0.3885|-0.3682|
72617374|NCT04053452|144766067|OTHER|C6, 3 months|Kendall's tau correlation coefficient|0.1194695|||||TWO_SIDED|95.0|-0.422|0.6686||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and GBS Disability score at 3 months after enrollment.||0.6686|-0.4220|
72617375|NCT04053452|144766067|OTHER|C7, 3 months|Kendall's tau correlation coefficient|-0.0593456|||||TWO_SIDED|95.0|-0.5651|0.454||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and GBS Disability score at 3 months after enrollment.||0.4540|-0.5651|
72617376|NCT04053452|144766067|OTHER|Vagus, 3 months|Kendall's tau correlation coefficient|-0.1920694|||||TWO_SIDED|95.0|-0.549|0.238||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and GBS Disability score at 3 months after enrollment.||0.238|-0.5490|
72617377|NCT04053452|144766067|OTHER|Median at wrist, 6 months|Kendall's tau correlation coefficient|0.3150905|||||TWO_SIDED|||||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and GBS Disability score at 6 months after enrollment.||||
72617378|NCT04053452|144766067|OTHER|Median at forearm, 6 months|Kendall's tau correlation coefficient|0.1203751|||||TWO_SIDED|||||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and GBS Disability score at 6 months after enrollment.||||
72617379|NCT04053452|144766067|OTHER|Median at cubital fossa, 6 months|Kendall's tau correlation coefficient|0.2526605|||||TWO_SIDED|95.0|-0.1865|0.643||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and GBS Disability score at 6 months after enrollment.||0.6430|-0.1865|
72617380|NCT04053452|144766067|OTHER|Median at humerus, 6 months|Kendall's tau correlation coefficient|-0.073601|||||TWO_SIDED|95.0|-0.5806|0.4223||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and GBS Disability score at 6 months after enrollment.||0.4223|-0.5806|
72617381|NCT04053452|144766067|OTHER|Median at axilla, 6 months|Kendall's tau correlation coefficient|0.01369735|||||TWO_SIDED|95.0|-0.5619|0.5236||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and GBS Disability score at 6 months after enrollment.||0.5236|-0.5619|
72617382|NCT04053452|144766067|OTHER|Ulnar at wrist, 6 months|Kendall's tau correlation coefficient|0.2685663|||||TWO_SIDED|95.0|-0.2488|0.7683||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and GBS Disability score at 6 months after enrollment.||0.7683|-0.2488|
72617383|NCT04053452|144766067|OTHER|Ulnar at forearm, 6 months|Kendall's tau correlation coefficient|0.1802776|||||TWO_SIDED|95.0|-0.2573|0.6027||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and GBS Disability score at 6 months after enrollment.||0.6027|-0.2573|
72617384|NCT04053452|144766067|OTHER|Ulnar at cubital fossa, 6 months|Kendall's tau correlation coefficient|0.2571327|||||TWO_SIDED|95.0|-0.2595|0.6227||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and GBS Disability score at 6 months after enrollment.||0.6227|-0.2595|
72617385|NCT04053452|144766067|OTHER|Ulnar at humerus, 6 months|Kendall's tau correlation coefficient|-0.0684867|||||TWO_SIDED|95.0|-0.5757|0.3944||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and GBS Disability score at 6 months after enrollment.||0.3944|-0.5757|
72371618|NCT00669409|144253450|SUPERIORITY_OR_OTHER_LEGACY||Least Mean Square Difference|-4.2|STANDARD_ERROR_OF_MEAN|8.33|||TWO_SIDED|95.0|-20.7|12.3||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||12.3|-20.7|
72617386|NCT04053452|144766067|OTHER|Ulnar at axilla, 6 months|Kendall's tau correlation coefficient|0.1929429|||||TWO_SIDED|95.0|-0.1828|0.555||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and GBS Disability score at 6 months after enrollment.||0.5550|-0.1828|
72617387|NCT04053452|144766067|OTHER|C6, 6 months|Kendall's tau correlation coefficient|0.1975146|||||TWO_SIDED|95.0|-0.3557|0.7344||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and GBS Disability score at 6 months after enrollment.||0.7344|-0.3557|
72617388|NCT04053452|144766067|OTHER|C7, 6 months|Kendall's tau correlation coefficient|-0.0754722|||||TWO_SIDED|95.0|-0.615|0.5083||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and GBS Disability score at 6 months after enrollment.||0.5083|-0.6150|
72617389|NCT04053452|144766067|OTHER|Vagus, 6 months|Kendall's tau correlation coefficient|-0.0706753|||||TWO_SIDED|95.0|-0.5042|0.3963||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and GBS Disability score at 6 months after enrollment.||0.3963|-0.5042|
72617390|NCT01421134|144766068|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-7.5|STANDARD_ERROR_OF_MEAN|1.37|<|0.0001|TWO_SIDED|95.0|-10.2|-4.8|||Mixed Models Analysis|||||-4.8|-10.2|<0.0001
72617391|NCT01421134|144766069|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-0.65|STANDARD_ERROR_OF_MEAN|0.157|<|0.0001|TWO_SIDED|95.0|-0.96|-0.34|||Mixed Models Analysis|||||-0.34|-0.96|<0.0001
72617392|NCT01421134|144766070|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-2.1|STANDARD_ERROR_OF_MEAN|0.5|<|0.0001|TWO_SIDED|95.0|-3.1|-1.1|||Mixed Models Analysis|||||-1.1|-3.1|<0.0001
72617393|NCT01421134|144766071|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-4.8|STANDARD_ERROR_OF_MEAN|1.21||0.0001|TWO_SIDED|95.0|-7.2|-2.4|||ANCOVA|||||-2.4|-7.2|0.0001
72617394|NCT01421134|144766072|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-4.5|STANDARD_ERROR_OF_MEAN|0.81|<|0.0001|TWO_SIDED|95.0|-6.1|-2.9|||ANCOVA|||||-2.9|-6.1|<0.0001
72617395|NCT01421134|144766073|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.615|||<|0.0001|TWO_SIDED|95.0|3.251|13.459|||Regression, Logistic||Odds Ratio was based on a logistic regression of response, with treatment group, baseline MADRS total score, and pooled center as fixed effects.|||13.459|3.251|<0.0001
72617396|NCT01421134|144766074|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.27|||<|0.0001|TWO_SIDED|95.0|2.105|8.663|||Regression, Logistic|||||8.663|2.105|<0.0001
72617397|NCT00986583|144766087|SUPERIORITY_OR_OTHER||Ratio of medians|1.34||||0.018|TWO_SIDED|95.0|1.05|1.72||This is for the primary comparison at 20 minute|ANCOVA||Ratio of medians of myoglobin measured at 20 minute for statin users vs. non-statin users|||1.72|1.05|0.018
72617398|NCT03767894|144766122|OTHER|Descriptive analysis (paired sample t-test)|Mean Difference (Final Values)|1.36||||0.24|TWO_SIDED|||||a priori threshold: p\<0.05 p-value is adjusted for multiple comparisons using Bonferroni correction.|t-test, 2 sided|Adjustment for p-value is 2.||Baseline scores compared to Post Unassisted condition (ARAT performed unassisted/without the use of the MyHand device).||||0.24
72432390|NCT02696785|144377179|SUPERIORITY||LSMean Difference|0.04|STANDARD_ERROR_OF_MEAN|3.082||0.989|TWO_SIDED|95.0|-6.03|6.12|||Mixed Models Analysis|||||6.12|-6.03|0.989
72617399|NCT03767894|144766122|OTHER|Descriptive analysis (paired sample t-test)|Mean Difference (Final Values)|-1.72||||0.207|TWO_SIDED|||||a priori threshold: p\<0.05 p-value is adjusted for multiple comparisons using Bonferroni correction.|t-test, 2 sided|Adjustment for p-value is 2.||Post Unassisted condition (ARAT performed unassisted/without the use of the MyHand device) compared to Post Assisted condition (ARAT performed assisted with the use of the MyHand device).||||0.207
72617400|NCT03767894|144766123|OTHER|Descriptive analysis (paired sample t-test)|Mean Difference (Final Values)|2.64||||0.026|TWO_SIDED|||||a priori threshold: p\<0.05|Paired sample T-test|2-tailed||Baseline scores compared to Post Unassisted condition (UEMF performed unassisted/without the use of the MyHand device).||||0.026
72617401|NCT03767894|144766125|OTHER|Descriptive analysis (paired Wilcoxon)|Mean Difference (Final Values)|-1.09||||0.442|TWO_SIDED|||||a priori threshold: p\<0.05 p-value is adjusted for multiple comparisons using Bonferroni correction.|Wilcoxon (Mann-Whitney)|Adjustment for p-value is 2.||Baseline scores compared to Post Unassisted condition (BBT performed unassisted/without the use of the MyHand device) of the impaired (hemiparetic) hand.||||0.442
72617402|NCT03767894|144766125|OTHER|Descriptive analysis (paired Wilcoxon)|Mean Difference (Final Values)|-1.0||||1|TWO_SIDED|||||a priori threshold: p\<0.05 p-value is adjusted for multiple comparisons using Bonferroni correction.|Wilcoxon (Mann-Whitney)|Adjustment for p-value is 2.||Post Unassisted condition (BBT performed unassisted/without the use of the MyHand device) compared to Post Assisted condition (BBT performed assisted with the use of the MyHand device).||||1.0
72617403|NCT00137280|144766227|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.3|||<|0.01|TWO_SIDED|95.0|1.47|3.58|||Regression, Logistic||Comparison group is the control (denominator)|||3.58|1.47|<0.01
72617404|NCT00137280|144766228|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.02|STANDARD_ERROR_OF_MEAN|5.93||0.03|||||||ANCOVA|||||||.03
72617405|NCT00137280|144766229|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.3|||<|0.01|TWO_SIDED|95.0|1.22|4.34|||Regression, Logistic||Comparison group is the control (denominator)|||4.34|1.22|<0.01
72617406|NCT00137280|144766230|SUPERIORITY_OR_OTHER|||||||0.11|||||||Chi-squared|||||||.11
72617407|NCT05001165|144766231|SUPERIORITY||Mean Difference (Net)|0.3|||||TWO_SIDED|95.0|-0.1|0.7|||Regression, Linear|||||0.7|-0.1|
72617408|NCT05001165|144766232|SUPERIORITY||Odds Ratio (OR)|1.34|||||TWO_SIDED|95.0|0.84|2.14|||Regression, Logistic|||||2.14|0.84|
72617409|NCT05001165|144766233|SUPERIORITY||Odds Ratio (OR)|1.06|||<|0.05|TWO_SIDED|95.0|0.64|1.76|||Regression, Logistic|||||1.76|0.64|<0.05
72617410|NCT05001165|144766234|SUPERIORITY||Odds Ratio (OR)|1.19|||||TWO_SIDED|95.0|0.73|1.93|||Regression, Logistic|||||1.93|0.73|
72617411|NCT05001165|144766235|SUPERIORITY||Odds Ratio (OR)|1.18|||||TWO_SIDED|95.0|0.68|2.05|||Regression, Logistic|||||2.05|0.68|
72617412|NCT05001165|144766236|SUPERIORITY||Odds Ratio (OR)|1.48|||||TWO_SIDED|95.0|0.88|2.51|||Regression, Logistic|||||2.51|0.88|
72617413|NCT05001165|144766237|SUPERIORITY||Odds Ratio (OR)|1.87|||||TWO_SIDED|95.0|0.99|3.64|||Regression, Logistic|||||3.64|0.99|
72617414|NCT05001165|144766238|SUPERIORITY||Odds Ratio (OR)|0.68|||||TWO_SIDED|95.0|0.34|1.33|||Regression, Logistic|||||1.33|0.34|
72617415|NCT04000724|144766243|SUPERIORITY||Average treatment effect|-0.54||||0.141|TWO_SIDED|95.0|-1.26|0.18|||Longitudinal Targeted Maximum Likelihood|||||0.18|-1.26|0.141
72617416|NCT04000724|144766243|SUPERIORITY||Average treatment effect|-0.51||||0.123|TWO_SIDED|95.0|-1.16|0.14|||Longitudinal Targeted Maximum Likelihood|||||0.14|-1.16|0.123
72617417|NCT04000724|144766244|SUPERIORITY||Average treatment effect|-0.24||||0.127|TWO_SIDED|95.0|-0.56|0.07|||Longitudinal Targeted Maximum Likelihood|||||.07|-.56|.127
72617418|NCT04000724|144766244|SUPERIORITY||Average treatment effect|-0.02||||0.899|TWO_SIDED|95.0|-0.34|0.3|||Longitudinal Targeted Maximum Likelihood|||||.30|-.34|.899
72617419|NCT02187055|144766277|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was a treatment difference larger than -13% at the population level|Difference in response rate|-7.73||||0.2101|TWO_SIDED|98.34|-16.29|0.83|||Normal approximation to proportions|Multiplicity-adjusted||||0.83|-16.29|0.2101
72617420|NCT02187055|144766277|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was a treatment difference larger than -13% at the population level|Difference in response rate|-5.5||||0.0512|TWO_SIDED|98.34|-13.98|2.98|||Normal approximation to proportions|Multiplicity-adjusted||||2.98|-13.98|0.0512
72617421|NCT02187055|144766277|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was a treatment difference larger than -13% at the population level|Difference in response rate|2.23|||<|0.0001|TWO_SIDED|98.34|-6.4|10.86|||Normal approximation to proportions|Multiplicity adjusted||||10.86|-6.40|<0.0001
72617422|NCT02187055|144766278|SUPERIORITY_OR_OTHER||LS mean difference|2.8|||||TWO_SIDED|95.0|1.23|4.41||||||||4.41|1.23|
72617423|NCT02187055|144766278|SUPERIORITY_OR_OTHER||LS mean difference|1.9|||||TWO_SIDED|95.0|0.33|3.49||||||||3.49|0.33|
72617424|NCT02187055|144766278|SUPERIORITY_OR_OTHER||LS mean difference|-0.9|||||TWO_SIDED|95.0|-2.51|0.68||||||||0.68|-2.51|
72617425|NCT02187055|144766279|SUPERIORITY_OR_OTHER||LS mean difference|2.6|||||TWO_SIDED|95.0|1.08|4.18||||||||4.18|1.08|
72617426|NCT02187055|144766279|SUPERIORITY_OR_OTHER||LS mean difference|1.9|||||TWO_SIDED|95.0|0.4|3.48||||||||3.48|0.40|
72617427|NCT02187055|144766279|SUPERIORITY_OR_OTHER||LS mean difference|-0.7|||||TWO_SIDED|95.0|-2.24|0.86||||||||0.86|-2.24|
72617428|NCT02187055|144766280|SUPERIORITY_OR_OTHER||LS mean difference|0.3|||||TWO_SIDED|95.0|0.16|0.5||||||||0.50|0.16|
72617429|NCT02187055|144766280|SUPERIORITY_OR_OTHER||LS mean difference|0.2|||||TWO_SIDED|95.0|0.05|0.39||||||||0.39|0.05|
72617430|NCT02187055|144766280|SUPERIORITY_OR_OTHER||LS mean difference|-0.1|||||TWO_SIDED|95.0|-0.28|0.06||||||||0.06|-0.28|
72617431|NCT02187055|144766281|SUPERIORITY_OR_OTHER||LS mean difference|0.3|||||TWO_SIDED|95.0|0.15|0.51||||||||0.51|0.15|
72617432|NCT02187055|144766281|SUPERIORITY_OR_OTHER||LS mean difference|0.3|||||TWO_SIDED|95.0|0.1|0.46||||||||0.46|0.10|
72617433|NCT02187055|144766281|SUPERIORITY_OR_OTHER||LS mean difference|0.0|||||TWO_SIDED|95.0|-0.23|0.13||||||||0.13|-0.23|
72617434|NCT02187055|144766282|SUPERIORITY_OR_OTHER||Difference in remission rate|-1.21|||||TWO_SIDED|95.0|-4.99|2.56||||||||2.56|-4.99|
72617435|NCT02187055|144766282|SUPERIORITY_OR_OTHER||Difference in remission rate|-1.78|||||TWO_SIDED|95.0|-5.59|2.04||||||||2.04|-5.59|
72617436|NCT02187055|144766282|SUPERIORITY_OR_OTHER||Difference in remission rate|-0.56|||||TWO_SIDED|95.0|-4.53|3.4||||||||3.40|-4.53|
72617437|NCT02187055|144766283|SUPERIORITY_OR_OTHER||Difference in remission rate|-3.4|||||TWO_SIDED|95.0|-7.95|1.15||||||||1.15|-7.95|
72617438|NCT02187055|144766283|SUPERIORITY_OR_OTHER||Difference in remission rate|-3.06|||||TWO_SIDED|95.0|-7.55|1.43||||||||1.43|-7.55|
72617439|NCT02187055|144766283|SUPERIORITY_OR_OTHER||Difference in remission rate|0.34|||||TWO_SIDED|95.0|-4.45|5.14||||||||5.14|-4.45|
72617440|NCT02187055|144766284|SUPERIORITY_OR_OTHER||Difference in remission rate|-3.67|||||TWO_SIDED|95.0|-8.29|0.94||||||||0.94|-8.29|
72617441|NCT02187055|144766284|SUPERIORITY_OR_OTHER||Difference in remission rate|-3.06|||||TWO_SIDED|95.0|-7.59|1.48||||||||1.48|-7.59|
72617442|NCT02187055|144766284|SUPERIORITY_OR_OTHER||Difference in remission rate|0.62|||||TWO_SIDED|95.0|-4.24|5.47||||||||5.47|-4.24|
72617443|NCT02187055|144766285|SUPERIORITY_OR_OTHER||Difference in remission rate|-1.55|||||TWO_SIDED|95.0|-6.03|2.93||||||||2.93|-6.03|
72617444|NCT02187055|144766285|SUPERIORITY_OR_OTHER||Difference in remission rate|-2.02|||||TWO_SIDED|95.0|-6.51|2.47||||||||2.47|-6.51|
72617445|NCT02187055|144766285|SUPERIORITY_OR_OTHER||Difference in remission rate|-0.47|||||TWO_SIDED|95.0|-5.11|4.18||||||||4.18|-5.11|
72617446|NCT02187055|144766286|SUPERIORITY_OR_OTHER||Difference in remission rate|-9.49|||||TWO_SIDED|95.0|-15.68|-3.3||||||||-3.30|-15.68|
72617447|NCT02187055|144766286|SUPERIORITY_OR_OTHER||Difference in remission rate|-6.89|||||TWO_SIDED|95.0|-12.94|-0.83||||||||-0.83|-12.94|
72617448|NCT02187055|144766286|SUPERIORITY_OR_OTHER||Difference in remission rate|2.61|||||TWO_SIDED|95.0|-3.86|9.07||||||||9.07|-3.86|
72617449|NCT02187055|144766287|SUPERIORITY_OR_OTHER||Difference in response rate|-6.24|||||TWO_SIDED|95.0|-13.32|0.84||||||||0.84|-13.32|
72617450|NCT02187055|144766287|SUPERIORITY_OR_OTHER||Difference in response rate|-3.66|||||TWO_SIDED|95.0|-10.69|3.37||||||||3.37|-10.69|
72617451|NCT02187055|144766287|SUPERIORITY_OR_OTHER||Difference in response rate|2.58|||||TWO_SIDED|95.0|-4.51|9.68||||||||9.68|-4.51|
72617452|NCT02187055|144766288|SUPERIORITY_OR_OTHER||Difference in response rate|-6.22|||||TWO_SIDED|95.0|-13.29|0.85||||||||0.85|-13.29|
72617453|NCT02187055|144766288|SUPERIORITY_OR_OTHER||Difference in response rate|-3.93|||||TWO_SIDED|95.0|-10.94|3.09||||||||3.09|-10.94|
72617454|NCT02187055|144766288|SUPERIORITY_OR_OTHER||Difference in response rate|2.3|||||TWO_SIDED|95.0|-4.79|9.39||||||||9.39|-4.79|
72617455|NCT02187055|144766289|SUPERIORITY_OR_OTHER||Difference in response rate|-6.02|||||TWO_SIDED|95.0|-12.05|0.0||||||||0.00|-12.05|
72617456|NCT02187055|144766289|SUPERIORITY_OR_OTHER||Difference in response rate|-6.89|||||TWO_SIDED|95.0|-12.9|-0.87||||||||-0.87|-12.90|
72617457|NCT02187055|144766289|SUPERIORITY_OR_OTHER||Difference in response rate|-0.87|||||TWO_SIDED|95.0|-7.17|5.44||||||||5.44|-7.17|
72617458|NCT02187055|144766290|SUPERIORITY_OR_OTHER||Difference in response rate|-4.87|||||TWO_SIDED|95.0|-11.92|2.18||||||||2.18|-11.92|
72617459|NCT02187055|144766290|SUPERIORITY_OR_OTHER||Difference in response rate|-5.48|||||TWO_SIDED|95.0|-12.49|1.52||||||||1.52|-12.49|
72617460|NCT02187055|144766290|SUPERIORITY_OR_OTHER||Difference in rresponse rate|-0.61|||||TWO_SIDED|95.0|-7.7|6.47||||||||6.47|-7.70|
72617461|NCT02187055|144766291|SUPERIORITY_OR_OTHER||Difference in response rate|-8.29|||||TWO_SIDED|95.0|-14.84|-1.75||||||||-1.75|-14.84|
72617462|NCT02187055|144766291|SUPERIORITY_OR_OTHER||Difference in response rate|-6.14|||||TWO_SIDED|95.0|-12.72|0.44||||||||0.44|-12.72|
72617463|NCT02187055|144766291|SUPERIORITY_OR_OTHER||Difference in response rate|2.15|||||TWO_SIDED|95.0|-4.22|8.52||||||||8.52|-4.22|
72617464|NCT02187055|144766292|SUPERIORITY_OR_OTHER||Difference in response rate|-6.77|||||TWO_SIDED|95.0|-12.61|-0.93||||||||-0.93|-12.61|
72617465|NCT02187055|144766292|SUPERIORITY_OR_OTHER||Difference in response rate|-2.5|||||TWO_SIDED|95.0|-8.09|3.1||||||||3.10|-8.09|
72617466|NCT02187055|144766292|SUPERIORITY_OR_OTHER||Difference in response rate|4.27|||||TWO_SIDED|95.0|-1.68|10.23||||||||10.23|-1.68|
72432391|NCT02696785|144377179|SUPERIORITY||LSMean Difference|2.5|STANDARD_ERROR_OF_MEAN|3.146||0.429|TWO_SIDED|95.0|-3.71|8.7|||Mixed Models Analysis|||||8.70|-3.71|0.429
72617467|NCT02187055|144766293|SUPERIORITY_OR_OTHER||LS mean difference|0.07|||||TWO_SIDED|95.0|-0.011|0.148||||||||0.148|-0.011|
72617468|NCT02187055|144766293|SUPERIORITY_OR_OTHER||LS mean difference|0.03|||||TWO_SIDED|95.0|-0.054|0.105||||||||0.105|-0.054|
72617469|NCT02187055|144766293|SUPERIORITY_OR_OTHER||LS mean difference|-0.04|||||TWO_SIDED|95.0|-0.122|0.037||||||||0.037|-0.122|
72617470|NCT02187055|144766294|SUPERIORITY_OR_OTHER||Difference in response rate|-4.07|||||TWO_SIDED|95.0|-10.68|2.55||||||||2.55|-10.68|
72617471|NCT02187055|144766294|SUPERIORITY_OR_OTHER||Difference in response rate|-1.21|||||TWO_SIDED|95.0|-7.87|5.44||||||||5.44|-7.87|
72617472|NCT02187055|144766294|SUPERIORITY_OR_OTHER||Difference in response rate|2.86|||||TWO_SIDED|95.0|-3.72|9.43||||||||9.43|-3.72|
72617473|NCT02187055|144766295|SUPERIORITY_OR_OTHER||LS mean difference|-1.2|||||TWO_SIDED|95.0|-2.28|-0.11||||||||-0.11|-2.28|
72617474|NCT02187055|144766295|SUPERIORITY_OR_OTHER||LS mean difference|-1.1|||||TWO_SIDED|95.0|-2.16|0.01||||||||0.01|-2.16|
72617475|NCT02187055|144766295|SUPERIORITY_OR_OTHER||LS mean difference|0.1|||||TWO_SIDED|95.0|-0.97|1.2||||||||1.20|-0.97|
72617476|NCT02187055|144766296|SUPERIORITY_OR_OTHER||LS mean difference|-0.4|||||TWO_SIDED|95.0|-1.74|0.85||||||||0.85|-1.74|
72617477|NCT02187055|144766296|SUPERIORITY_OR_OTHER||LS mean difference|0.8|||||TWO_SIDED|95.0|-0.48|2.11||||||||2.11|-0.48|
72617478|NCT02187055|144766296|SUPERIORITY_OR_OTHER||LS mean difference|1.3|||||TWO_SIDED|95.0|-0.04|2.56||||||||2.56|-0.04|
72617479|NCT02187055|144766297|SUPERIORITY_OR_OTHER||LS mean difference|-0.9|||||TWO_SIDED|95.0|-2.22|0.39||||||||0.39|-2.22|
72617480|NCT02187055|144766297|SUPERIORITY_OR_OTHER||LS mean difference|-0.9|||||TWO_SIDED|95.0|-2.19|0.42||||||||0.42|-2.19|
72617481|NCT02187055|144766297|SUPERIORITY_OR_OTHER||LS mean difference|0.0|||||TWO_SIDED|95.0|-1.27|1.34||||||||1.34|-1.27|
72617482|NCT02187055|144766298|SUPERIORITY_OR_OTHER||LS mean difference|-0.3|||||TWO_SIDED|95.0|-1.52|0.87||||||||0.87|-1.52|
72617483|NCT02187055|144766298|SUPERIORITY_OR_OTHER||LS mean difference|0.4|||||TWO_SIDED|95.0|-0.8|1.58||||||||1.58|-0.80|
72617484|NCT02187055|144766298|SUPERIORITY_OR_OTHER||LS mean difference|0.7|||||TWO_SIDED|95.0|-0.47|1.91||||||||1.91|-0.47|
72617485|NCT02187055|144766299|SUPERIORITY_OR_OTHER||LS mean difference|-2.0|||||TWO_SIDED|95.0|-3.25|-0.8||||||||-0.80|-3.25|
72617486|NCT02187055|144766299|SUPERIORITY_OR_OTHER||LS mean difference|-1.7|||||TWO_SIDED|95.0|-2.91|-0.47||||||||-0.47|-2.91|
72617487|NCT02187055|144766299|SUPERIORITY_OR_OTHER||LS mean difference|0.3|||||TWO_SIDED|95.0|-0.89|1.55||||||||1.55|-0.89|
72617488|NCT02187055|144766300|SUPERIORITY_OR_OTHER||LS mean difference|-1.2|||||TWO_SIDED|95.0|-2.27|-0.05||||||||-0.05|-2.27|
72617489|NCT02187055|144766300|SUPERIORITY_OR_OTHER||LS mean difference|-0.3|||||TWO_SIDED|95.0|-1.4|0.82||||||||0.82|-1.40|
72617490|NCT02187055|144766300|SUPERIORITY_OR_OTHER||LS mean difference|0.9|||||TWO_SIDED|95.0|-0.25|1.98||||||||1.98|-0.25|
72617491|NCT02187055|144766301|SUPERIORITY_OR_OTHER||LS mean difference|-0.5|||||TWO_SIDED|95.0|-1.71|0.68||||||||0.68|-1.71|
72617492|NCT02187055|144766301|SUPERIORITY_OR_OTHER||LS mean difference|-0.1|||||TWO_SIDED|95.0|-1.33|1.05||||||||1.05|-1.33|
72617493|NCT02187055|144766301|SUPERIORITY_OR_OTHER||LS mean difference|0.4|||||TWO_SIDED|95.0|-0.83|1.57||||||||1.57|-0.83|
72617494|NCT02187055|144766302|SUPERIORITY_OR_OTHER||LS mean difference|-0.9|||||TWO_SIDED|95.0|-2.2|0.45||||||||0.45|-2.20|
72617495|NCT02187055|144766302|SUPERIORITY_OR_OTHER||LS mean difference|0.2|||||TWO_SIDED|95.0|-1.13|1.51||||||||1.51|-1.13|
72617496|NCT02187055|144766302|SUPERIORITY_OR_OTHER||LS mean difference|1.1|||||TWO_SIDED|95.0|-0.26|2.39||||||||2.39|-0.26|
72617497|NCT02187055|144766303|SUPERIORITY_OR_OTHER||LS mean difference|-1.1|||||TWO_SIDED|95.0|-2.54|0.39||||||||0.39|-2.54|
72617498|NCT02187055|144766303|SUPERIORITY_OR_OTHER||LS mean difference|0.7|||||TWO_SIDED|95.0|-0.76|2.16||||||||2.16|-0.76|
72617499|NCT02187055|144766303|SUPERIORITY_OR_OTHER||LS mean difference|1.8|||||TWO_SIDED|95.0|0.3|3.24||||||||3.24|0.30|
72617500|NCT02187055|144766304|SUPERIORITY_OR_OTHER||LS mean difference|-0.2|||||TWO_SIDED|95.0|-1.55|1.08||||||||1.08|-1.55|
72617501|NCT02187055|144766304|SUPERIORITY_OR_OTHER||LS mean difference|0.3|||||TWO_SIDED|95.0|-1.01|1.62||||||||1.62|-1.01|
72617502|NCT02187055|144766304|SUPERIORITY_OR_OTHER||LS mean difference|0.5|||||TWO_SIDED|95.0|-0.78|1.86||||||||1.86|-0.78|
72617503|NCT02187055|144766305|SUPERIORITY_OR_OTHER||LS mean difference|-0.43|||||TWO_SIDED|95.0|-2.279|1.427||||||Work hours missed due to problems||1.427|-2.279|
72617504|NCT02187055|144766305|SUPERIORITY_OR_OTHER||LS mean difference|-0.87|||||TWO_SIDED|95.0|-2.783|1.044||||||Work hours missed due to problems||1.044|-2.783|
72617505|NCT02187055|144766305|SUPERIORITY_OR_OTHER||LS mean difference|-0.44|||||TWO_SIDED|95.0|-2.349|1.462||||||Work hours missed due to problems||1.462|-2.349|
72617506|NCT02187055|144766305|SUPERIORITY_OR_OTHER||LS mean difference|-0.29|||||TWO_SIDED|95.0|-2.928|2.346||||||Work hours missed other reason||2.346|-2.928|
72617507|NCT02187055|144766305|SUPERIORITY_OR_OTHER||LS mean difference|0.9|||||TWO_SIDED|95.0|-1.832|3.64||||||Work hours missed other reason||3.640|-1.832|
72617508|NCT02187055|144766305|SUPERIORITY_OR_OTHER||LS mean difference|1.2|||||TWO_SIDED|95.0|-1.52|3.911||||||Work hours missed other reason||3.911|-1.520|
72617509|NCT02187055|144766305|SUPERIORITY_OR_OTHER||LS mean difference|4.95|||||TWO_SIDED|95.0|0.52|9.37||||||Hours worked in past 7 days||9.370|0.520|
72617510|NCT02187055|144766305|SUPERIORITY_OR_OTHER||LS mean difference|2.85|||||TWO_SIDED|90.0|-1.736|7.43||||||Hours worked in past 7 days||7.430|-1.736|
72617511|NCT02187055|144766305|SUPERIORITY_OR_OTHER||LS mean difference|-2.1|||||TWO_SIDED|95.0|-6.65|2.454||||||Hours worked in past 7 days||2.454|-6.650|
72617512|NCT02187055|144766305|SUPERIORITY_OR_OTHER||LS mean difference|0.21|||||TWO_SIDED|95.0|-0.373|0.786||||||Problems affecting productivity||0.786|-0.373|
72617513|NCT02187055|144766305|SUPERIORITY_OR_OTHER||LS mean difference|0.01|||||TWO_SIDED|95.0|-0.578|0.607||||||Problems affecting productivity||0.607|-0.578|
72617514|NCT02187055|144766305|SUPERIORITY_OR_OTHER||LS mean difference|-0.19|||||TWO_SIDED|95.0|-0.784|0.4||||||Problems affecting productivity||0.400|-0.784|
72617515|NCT02187055|144766305|SUPERIORITY_OR_OTHER||LS mean difference|0.24|||||TWO_SIDED|95.0|-0.112|0.587||||||Problem affecting daily activities||0.587|-0.112|
72617516|NCT02187055|144766305|SUPERIORITY_OR_OTHER||LS mean difference|0.01|||||TWO_SIDED|95.0|-0.341|0.357||||||Problem affecting daily activities||0.357|-0.341|
72617517|NCT02187055|144766305|SUPERIORITY_OR_OTHER||LS mean difference|-0.23|||||TWO_SIDED|95.0|-0.582|0.122||||||Problem affecting daily activities||0.122|-0.582|
72617518|NCT02187055|144766305|SUPERIORITY_OR_OTHER||LS mean difference|-1.1|||||TWO_SIDED|95.0|-5.748|3.553||||||% work time missed due to health||3.553|-5.748|
72617519|NCT02187055|144766305|SUPERIORITY_OR_OTHER||LS mean difference|-2.64|||||TWO_SIDED|95.0|-7.339|2.067||||||% work time missed due to health||2.067|-7.339|
72617520|NCT02187055|144766305|SUPERIORITY_OR_OTHER||LS mean difference|-1.54|||||TWO_SIDED|95.0|-6.283|3.207||||||% work time missed due to health||3.207|-6.283|
72617521|NCT02187055|144766305|SUPERIORITY_OR_OTHER||LS mean difference|2.07|||||TWO_SIDED|95.0|-3.726|7.858||||||% impairment while working due to health||7.858|-3.726|
72617522|NCT02187055|144766305|SUPERIORITY_OR_OTHER||LS mean difference|0.15|||||TWO_SIDED|95.0|-5.777|6.068||||||% impairment while working due to health||6.068|-5.777|
72617523|NCT02187055|144766305|SUPERIORITY_OR_OTHER||LS mean difference|-1.92|||||TWO_SIDED|95.0|-7.839|3.998||||||% impairment while working due to health||3.998|-7.839|
72617524|NCT02187055|144766305|SUPERIORITY_OR_OTHER||LS mean difference|2.11|||||TWO_SIDED|95.0|-4.664|8.877||||||% overall work impairment due to health||8.877|-4.664|
72617525|NCT02187055|144766305|SUPERIORITY_OR_OTHER||LS mean difference|1.71|||||TWO_SIDED|95.0|-5.164|8.58||||||% overall work impairment due to health||8.580|-5.164|
72617526|NCT02187055|144766305|SUPERIORITY_OR_OTHER||LS mean difference|-0.4|||||TWO_SIDED|95.0|-7.307|6.51||||||% overall work impairment due to health||6.510|-7.307|
72617527|NCT02187055|144766305|SUPERIORITY_OR_OTHER||LS mean difference|2.38|||||TWO_SIDED|95.0|-1.118|5.873||||||% activity impairment due to health||5.873|-1.118|
72617528|NCT02187055|144766305|SUPERIORITY_OR_OTHER||LS mean difference|0.08|||||TWO_SIDED|95.0|-3.411|3.573||||||% activity impairment due to health||3.573|-3.411|
72617529|NCT02187055|144766305|SUPERIORITY_OR_OTHER||LS mean difference|-2.3|||||TWO_SIDED|95.0|-5.818|1.225||||||% activity impairment due to health||1.225|-5.818|
72617530|NCT02187055|144766306|SUPERIORITY_OR_OTHER||LS mean difference|-0.02|||||TWO_SIDED|95.0|-0.057|0.011||||||Utility score||0.011|-0.057|
72617531|NCT02187055|144766306|SUPERIORITY_OR_OTHER||LS mean difference|-0.02|||||TWO_SIDED|95.0|-0.054|0.013||||||Utility score||0.013|-0.054|
72617532|NCT02187055|144766306|SUPERIORITY_OR_OTHER||LS mean difference|0.0|||||TWO_SIDED|95.0|-0.031|0.036||||||Utility score||0.036|-0.031|
72617533|NCT02187055|144766306|SUPERIORITY_OR_OTHER||LS mean difference|-0.03|||||TWO_SIDED|95.0|-0.098|0.042||||||Mobility score||0.042|-0.098|
72617534|NCT02187055|144766306|SUPERIORITY_OR_OTHER||LS mean difference|-0.01|||||TWO_SIDED|95.0|-0.079|0.06||||||Mobility score||0.060|-0.079|
72617535|NCT02187055|144766306|SUPERIORITY_OR_OTHER||LS mean difference|0.02|||||TWO_SIDED|95.0|-0.051|0.089||||||Mobility score||0.089|-0.051|
72617536|NCT02187055|144766306|SUPERIORITY_OR_OTHER||LS mean difference|0.06|||||TWO_SIDED|95.0|-0.014|0.127||||||Self-care score||0.127|-0.014|
72617537|NCT02187055|144766306|SUPERIORITY_OR_OTHER||LS mean difference|0.04|||||TWO_SIDED|95.0|-0.027|0.114||||||Self-care score||0.114|-0.027|
72617538|NCT02187055|144766306|SUPERIORITY_OR_OTHER||LS mean difference|-0.01|||||TWO_SIDED|95.0|-0.083|0.058||||||Self-care score||0.058|-0.083|
72617539|NCT02187055|144766306|SUPERIORITY_OR_OTHER||LS mean difference|0.01|||||TWO_SIDED|95.0|-0.062|0.084||||||Usual activities score||0.084|-0.062|
72617540|NCT02187055|144766306|SUPERIORITY_OR_OTHER||LS mean difference|0.06|||||TWO_SIDED|95.0|-0.018|0.129||||||Usual activities score||0.129|-0.018|
72617541|NCT02187055|144766306|SUPERIORITY_OR_OTHER||LS mean difference|0.04|||||TWO_SIDED|95.0|-0.029|0.118||||||Usual activities score||0.118|-0.029|
72617542|NCT02187055|144766306|SUPERIORITY_OR_OTHER||LS mean difference|0.03|||||TWO_SIDED|95.0|-0.041|0.091||||||Pain/discomfort score||0.091|-0.041|
72617543|NCT02187055|144766306|SUPERIORITY_OR_OTHER||LS mean difference|0.05|||||TWO_SIDED|95.0|-0.015|0.116||||||Pain/discomfort score||0.116|-0.015|
72617544|NCT02187055|144766306|SUPERIORITY_OR_OTHER||LS mean difference|0.03|||||TWO_SIDED|95.0|-0.041|0.091||||||Pain/discomfort score||0.091|-0.041|
72617545|NCT02187055|144766306|SUPERIORITY_OR_OTHER||LS mean difference|0.03|||||TWO_SIDED|95.0|-0.046|0.103||||||Anxiety/depression score||0.103|-0.046|
72617546|NCT02187055|144766306|SUPERIORITY_OR_OTHER||LS mean difference|0.01|||||TWO_SIDED|95.0|-0.066|0.083||||||Anxiety/depression score||0.083|-0.066|
72617547|NCT02187055|144766306|SUPERIORITY_OR_OTHER||LS mean difference|-0.02|||||TWO_SIDED|95.0|-0.094|0.055||||||Anxiety/depression score||0.055|-0.094|
72617548|NCT02187055|144766306|SUPERIORITY_OR_OTHER||LS mean difference|-0.14|||||TWO_SIDED|95.0|-2.934|2.648||||||VAS score||2.648|-2.934|
72617549|NCT02187055|144766306|SUPERIORITY_OR_OTHER||LS mean difference|1.23|||||TWO_SIDED|95.0|-1.556|4.016||||||VAS score||4.016|-1.556|
72617550|NCT02187055|144766306|SUPERIORITY_OR_OTHER||LS mean difference|1.37|||||TWO_SIDED|95.0|-1.425|4.171||||||VAS score||4.171|-1.425|
72617551|NCT02187055|144766307|SUPERIORITY_OR_OTHER||LS mean difference|-0.45|||||TWO_SIDED|95.0|-1.706|0.808||||||||0.808|-1.706|
72617552|NCT02187055|144766307|SUPERIORITY_OR_OTHER||LS mean difference|1.07|||||TWO_SIDED|95.0|-0.178|2.325||||||||2.325|-0.178|
72617553|NCT02187055|144766307|SUPERIORITY_OR_OTHER||LS mean difference|1.52|||||TWO_SIDED|95.0|0.266|2.779||||||||2.779|0.266|
72617554|NCT03520387|144766309|SUPERIORITY||Mean Difference (Final Values)|-3.3|STANDARD_ERROR_OF_MEAN|3.1|||TWO_SIDED|95.0|-10.2|3.7|||||Analysis of the MAIN EFFECT of LRFA (Group A + Group C) vs. simulated LRFA (Group B + Group D) on the outcome at 3 months, after adjustment for age and baseline value of the outcome. Negative scores indicate benefit with LRFA over simulated LRFA.|||3.7|-10.2|
72617555|NCT03520387|144766309|SUPERIORITY||Mean Difference (Final Values)|-6.3|STANDARD_ERROR_OF_MEAN|2.1|||TWO_SIDED|95.0|-11.0|-1.6|||||Analysis of the MAIN EFFECT of AcTIVE-CBT (Group A + Group B) vs. TBSCE (Group C + Group D) on the outcome at 3 months, after adjustment for age and baseline value of the outcome. Negative scores indicate benefit with AcTIVE-CBT over TBSCE.|||-1.6|-11.0|
72617556|NCT03520387|144766310|SUPERIORITY||Mean Difference (Final Values)|-6059.0|STANDARD_ERROR_OF_MEAN|2832.7|||TWO_SIDED|95.0|-12467.0|349.1|||||This is an analysis of the MAIN EFFECT of LRFA (Group A + Group C) vs. simulated LRFA (Group B + Group D) on CHANGE in step counts, after adjustment for age and baseline step counts. Positive values show increased steps with LRFA over simulated LRFA.|||349.1|-12467.0|
72617557|NCT03520387|144766310|SUPERIORITY||Mean Difference (Final Values)|2081.9|STANDARD_ERROR_OF_MEAN|2983.2|||TWO_SIDED|95.0|-4666.6|8830.4|||||This is an analysis of the MAIN EFFECT of AcTIVE-CBT (Group A + Group B) vs. TBSCE (Group C + Group D) on CHANGE in step counts, after adjustment for age and baseline step counts.Positive values show increased steps with AcTIVE-CBT over TBSCE.|||8830.4|-4666.6|
72617558|NCT03520387|144766311|SUPERIORITY||Mean Difference (Final Values)|-1.0|STANDARD_ERROR_OF_MEAN|1.8|||TWO_SIDED|95.0|-5.2|3.1|||||Analysis of the MAIN EFFECT of LRFA (Group A + Group C) vs. simulated LRFA (Group B + Group D) on the outcome at 3 months, after adjustment for age and baseline value of the outcome. Negative scores indicate benefit with LRFA over simulated LRFA.|||3.1|-5.2|
72617559|NCT03520387|144766311|SUPERIORITY||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|1.7|||TWO_SIDED|95.0|-4.2|3.6|||||Analysis of the MAIN EFFECT of AcTIVE-CBT (Group A + Group B) vs. TBSCE (Group C + Group D) on the outcome at 3 months, after adjustment for age and baseline value of the outcome. Negative scores indicate benefit with AcTIVE-CBT over TBSCE.|||3.6|-4.2|
72617560|NCT03520387|144766312|SUPERIORITY||Mean Difference (Final Values)|1.0|STANDARD_ERROR_OF_MEAN|4.0|||TWO_SIDED|95.0|-8.1|10.1|||||Analysis of the MAIN EFFECT of LRFA (Group A + Group C) vs. simulated LRFA (Group B + Group D) on the outcome at 3 months after adjustment for age and baseline value of the outcome. Positive scores indicate better health with LRFA vs. simulated LRFA.|PROMIS physical health scores||10.1|-8.1|
72617561|NCT03520387|144766312|SUPERIORITY||Mean Difference (Final Values)|6.2|STANDARD_ERROR_OF_MEAN|2.9|||TWO_SIDED|95.0|-0.4|12.9|||||Analysis of the MAIN EFFECT of AcTIVE-CBT (Group A + Group B) vs. TBSCE (Group C + Group D) on the outcome at 3 months after adjustment for age and baseline value of the outcome. Positive scores indicate better health with AcTIVE-CBT vs. TBSCE|PROMIS physical health scores||12.9|-0.4|
72617562|NCT03520387|144766312|SUPERIORITY||Mean Difference (Final Values)|3.7|STANDARD_ERROR_OF_MEAN|4.0|||TWO_SIDED|95.0|-5.4|12.7|||||Analysis of the MAIN EFFECT of LRFA (Group A + Group C) vs. simulated LRFA (Group B + Group D) on the outcome at 3 months after adjustment for age and baseline value of the outcome. Positive scores indicate better health with LRFA vs. simulated LRFA.|PROMIS mental health scores||12.7|-5.4|
72617563|NCT03520387|144766312|SUPERIORITY||Mean Difference (Final Values)|1.8|STANDARD_ERROR_OF_MEAN|3.9|||TWO_SIDED|95.0|-7.0|10.6|||||Analysis of the MAIN EFFECT of AcTIVE-CBT (Group A + Group B) vs. TBSCE (Group C + Group D) on the outcome at 3 months after adjustment for age and baseline value of the outcome. Positive scores indicate better health with AcTIVE-CBT vs. TBSCE|PROMIS mental health scores||10.6|-7.0|
72617564|NCT03520387|144766313|SUPERIORITY||Mean Difference (Final Values)|-2.9|STANDARD_ERROR_OF_MEAN|2.1|||TWO_SIDED|95.0|-7.7|1.9|||||Analysis of the MAIN EFFECT of LRFA (Group A + Group C) vs. simulated LRFA (Group B + Group D) on the outcome at 3 months, after adjustment for age and baseline value of the outcome. Negative scores indicate lower doses with LRFA over simulated LRFA.|||1.9|-7.7|
72617565|NCT03520387|144766313|SUPERIORITY||Mean Difference (Final Values)|-3.3|STANDARD_ERROR_OF_MEAN|1.9|||TWO_SIDED|95.0|-7.5|1.0|||||Analysis of the MAIN EFFECT of AcTIVE-CBT (Group A + Group B) vs. TBSCE (Group C + Group D) on the outcome at 3 months, after adjustment for age and baseline value of the outcome. Negative scores indicate lower doses with AcTIVE-CBT over TBSCE.|||1.0|-7.5|
72617566|NCT03520387|144766314|SUPERIORITY||Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|0.7|||TWO_SIDED|95.0|-1.4|1.7|||||Analysis of the MAIN EFFECT of LRFA (Group A + Group C) vs. simulated LRFA (Group B + Group D) on the outcome at 3 months, after adjustment for age. Positive scores indicate perceived benefit with LRFA over simulated LRFA.|||1.7|-1.4|
72617567|NCT03520387|144766314|SUPERIORITY||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.6|||TWO_SIDED|95.0|-1.3|1.5|||||Analysis of the MAIN EFFECT of AcTIVE-CBT (Group A + Group B) vs. TBSCE (Group C + Group D) on the outcome at 3 months, after adjustment for age and baseline value of the outcome. Positive scores indicate perceived benefit with AcTIVE-CBT over TBSCE.|||1.5|-1.3|
72617568|NCT03520387|144766315|SUPERIORITY||Mean Difference (Final Values)|-0.9|STANDARD_ERROR_OF_MEAN|2.0|||TWO_SIDED|95.0|-5.5|3.7|||||Analysis of the MAIN EFFECT of LRFA (Group A + Group C) vs. simulated LRFA (Group B + Group D) on the outcome at 3 months after adjustment for age and baseline value of the outcome. Negative scores indicate less pain with LRFA over simulated LRFA.|||3.7|-5.5|
72617569|NCT03520387|144766315|SUPERIORITY||Mean Difference (Final Values)|-1.4|STANDARD_ERROR_OF_MEAN|1.8|||TWO_SIDED|95.0|-5.4|2.6|||||Analysis of the MAIN EFFECT of AcTIVE-CBT (Group A + Group B) vs. TBSCE (Group C + Group D) on the outcome at 3 months after adjustment for age and baseline value of the outcome. Negative scores indicate less pain with AcTIVE-CBT vs. TBSCE|||2.6|-5.4|
72617570|NCT03520387|144766316|SUPERIORITY||Mean Difference (Final Values)|1.3|STANDARD_ERROR_OF_MEAN|0.8|||TWO_SIDED|95.0|-0.5|3.0|||||Analysis of the MAIN EFFECT of LRFA (Group A + Group C) vs. simulated LRFA (Group B + Group D) on the outcome at 3 months, after adjustment for age. Positive scores indicate more satisfaction with LRFA over simulated LRFA.|||3.0|-0.5|
72617571|NCT03520387|144766316|SUPERIORITY||Mean Difference (Final Values)|1.2|STANDARD_ERROR_OF_MEAN|0.7|||TWO_SIDED|95.0|-0.4|2.8|||||Analysis of the MAIN EFFECT of AcTIVE-CBT (Group A + Group B) vs. TBSCE (Group C + Group D) on the outcome at 3 months, after adjustment for age. Positive scores indicate more satisfaction with AcTIVE-CBT over TBSCE.|||2.8|-0.4|
72617572|NCT03520387|144766317|SUPERIORITY||Mean Difference (Final Values)|-637.0|STANDARD_ERROR_OF_MEAN|433.3|||TWO_SIDED|95.0|-1636.2|362.1|||||Analysis of the MAIN EFFECT of LRFA (Group A + Group C) vs. simulated LRFA (Group B + Group D) on the outcome at 3 months adjusting for age and baseline value of the outcome. Positive scores indicate greater activity with LRFA over simulated LRFA.|||362.1|-1636.2|
72617573|NCT03520387|144766317|SUPERIORITY||Mean Difference (Final Values)|572.2|STANDARD_ERROR_OF_MEAN|334.5|||TWO_SIDED|95.0|-199.3|1343.6|||||Analysis of the MAIN EFFECT of AcTIVE-CBT (Group A + Group B) vs. TBSCE (Group C + Group D) on the outcome at 3 months adjusting for age and baseline value of the outcome. Positive scores indicate more satisfaction with AcTIVE-CBT over TBSCE.|||1343.6|-199.3|
72617574|NCT03336866|144766318|OTHER|The effect of IXT-m200 on METH exposure was evaluated with a linear mixed effects model. The response variable in the model was the natural-log transformed change in METH exposure parameters: AUCinf. The model contained fixed effects for treatment, day (categorical day postdose), natural-log transformed Day 1 baseline parameter and a treatment-by-day interaction, and a random effect for subject.|||||<|0.0001||||||Geometric LS Means Ratios of change in METH exposure for IXT-m200 compared to Placebo on Day 5 (primary). Threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Values were compared by a statistical analysis of change from Day 1 in METH PK parameters following IXT-m200 dosing. Geometric LS Mean change from Day 1 for each treatment on each day were calculated. Geometric LS Means Ratios of change in METH exposure for each dose level of IXT-m200 compared to Placebo on each Day 5 (primary), Day 12, Day 19 and Day 26 were calculated along with the 95% confidence intervals.||||<0.0001
72617575|NCT03336866|144766318|OTHER|The effect of IXT-m200 on METH exposure was evaluated with a linear mixed effects model. The response variable in the model was the natural-log transformed change in METH exposure parameters: AUCinf. The model contained fixed effects for treatment, day (categorical day postdose), natural-log transformed Day 1 baseline parameter and a treatment-by-day interaction, and a random effect for subject.|||||<|0.0001||||||Geometric LS Means Ratios of change in METH exposure for IXT-m200 compared to Placebo on Day 12. Threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Values were compared by a statistical analysis of change from Day 1 in METH PK parameters following IXT-m200 dosing. Geometric LS Mean change from Day 1 for each treatment on each day were calculated. Geometric LS Means Ratios of change in METH exposure for each dose level of IXT-m200 compared to Placebo on each Day 5 (primary), Day 12, Day 19 and Day 26 were calculated along with the 95% confidence intervals.||||<0.0001
72622304|NCT04250207|144774537|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.||||||0.0001|||||||Chi-square or Fisher exact|||Week 9||||0.0001
72622305|NCT04250207|144774537|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.||||||0.0028|||||||Chi-square or Fisher exact|||Week 9||||0.0028
72371619|NCT00669409|144253450|SUPERIORITY_OR_OTHER_LEGACY||Least Mean Square Difference|-19.3|STANDARD_ERROR_OF_MEAN|8.25|||TWO_SIDED|95.0|-35.6|-3.0||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-3.0|-35.6|
72617576|NCT03336866|144766318|OTHER|The effect of IXT-m200 on METH exposure was evaluated with a linear mixed effects model. The response variable in the model was the natural-log transformed change in METH exposure parameters: AUCinf. The model contained fixed effects for treatment, day (categorical day postdose), natural-log transformed Day 1 baseline parameter and a treatment-by-day interaction, and a random effect for subject.|||||<|0.0001||||||Geometric LS Means Ratios of change in METH exposure for IXT-m200 compared to Placebo on Day 19 (primary). Threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Values were compared by a statistical analysis of change from Day 1 in METH PK parameters following IXT-m200 dosing. Geometric LS Mean change from Day 1 for each treatment on each day were calculated. Geometric LS Means Ratios of change in METH exposure for each dose level of IXT-m200 compared to Placebo on each Day 5 (primary), Day 12, Day 19 and Day 26 were calculated along with the 95% confidence intervals.||||<0.0001
72617577|NCT03336866|144766318|OTHER|The effect of IXT-m200 on METH exposure was evaluated with a linear mixed effects model. The response variable in the model was the natural-log transformed change in METH exposure parameters: AUCinf. The model contained fixed effects for treatment, day (categorical day postdose), natural-log transformed Day 1 baseline parameter and a treatment-by-day interaction, and a random effect for subject.|||||<|0.0001||||||Geometric LS Means Ratios of change in METH exposure for IXT-m200 compared to Placebo on Day 26. Threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Values were compared by a statistical analysis of change from Day 1 in METH PK parameters following IXT-m200 dosing. Geometric LS Mean change from Day 1 for each treatment on each day were calculated. Geometric LS Means Ratios of change in METH exposure for each dose level of IXT-m200 compared to Placebo on each Day 5 (primary), Day 12, Day 19 and Day 26 were calculated along with the 95% confidence intervals.||||<0.0001
72617578|NCT03336866|144766318|OTHER|The effect of IXT-m200 on METH exposure was evaluated with a linear mixed effects model. The response variable in the model was the natural-log transformed change in METH exposure parameters: AUCinf. The model contained fixed effects for treatment, day (categorical day postdose), natural-log transformed Day 1 baseline parameter and a treatment-by-day interaction, and a random effect for subject.|||||<|0.0001||||||Geometric LS Means Ratios of change in METH exposure for IXT-m200 compared to Placebo on Day 5 (primary). Threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Values were compared by a statistical analysis of change from Day 1 in METH PK parameters following IXT-m200 dosing. Geometric LS Mean change from Day 1 for each treatment on each day were calculated. Geometric LS Means Ratios of change in METH exposure for each dose level of IXT-m200 compared to Placebo on each Day 5 (primary), Day 12, Day 19 and Day 26 were calculated along with the 95% confidence intervals.||||<0.0001
72617579|NCT03336866|144766318|OTHER|The effect of IXT-m200 on METH exposure was evaluated with a linear mixed effects model. The response variable in the model was the natural-log transformed change in METH exposure parameters: AUCinf. The model contained fixed effects for treatment, day (categorical day postdose), natural-log transformed Day 1 baseline parameter and a treatment-by-day interaction, and a random effect for subject.|||||<|0.0001||||||Geometric LS Means Ratios of change in METH exposure for IXT-m200 compared to Placebo on Day 12. Threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Values were compared by a statistical analysis of change from Day 1 in METH PK parameters following IXT-m200 dosing. Geometric LS Mean change from Day 1 for each treatment on each day were calculated. Geometric LS Means Ratios of change in METH exposure for each dose level of IXT-m200 compared to Placebo on each Day 5 (primary), Day 12, Day 19 and Day 26 were calculated along with the 95% confidence intervals.||||<0.0001
72617580|NCT03336866|144766318|OTHER|The effect of IXT-m200 on METH exposure was evaluated with a linear mixed effects model. The response variable in the model was the natural-log transformed change in METH exposure parameters: AUCinf. The model contained fixed effects for treatment, day (categorical day postdose), natural-log transformed Day 1 baseline parameter and a treatment-by-day interaction, and a random effect for subject.|||||<|0.0001||||||Geometric LS Means Ratios of change in METH exposure for IXT-m200 compared to Placebo on Day 19. Threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Values were compared by a statistical analysis of change from Day 1 in METH PK parameters following IXT-m200 dosing. Geometric LS Mean change from Day 1 for each treatment on each day were calculated. Geometric LS Means Ratios of change in METH exposure for each dose level of IXT-m200 compared to Placebo on each Day 5 (primary), Day 12, Day 19 and Day 26 were calculated along with the 95% confidence intervals.||||<0.0001
72617581|NCT03336866|144766318|OTHER|The effect of IXT-m200 on METH exposure was evaluated with a linear mixed effects model. The response variable in the model was the natural-log transformed change in METH exposure parameters: AUCinf. The model contained fixed effects for treatment, day (categorical day postdose), natural-log transformed Day 1 baseline parameter and a treatment-by-day interaction, and a random effect for subject.|||||<|0.0001||||||Geometric LS Means Ratios of change in METH exposure for IXT-m200 compared to Placebo on Day 26. Threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Values were compared by a statistical analysis of change from Day 1 in METH PK parameters following IXT-m200 dosing. Geometric LS Mean change from Day 1 for each treatment on each day were calculated. Geometric LS Means Ratios of change in METH exposure for each dose level of IXT-m200 compared to Placebo on each Day 5 (primary), Day 12, Day 19 and Day 26 were calculated along with the 95% confidence intervals.||||<0.0001
72617582|NCT03336866|144766319|OTHER|The effect of IXT-m200 on METH exposure was evaluated with a linear mixed effects model. The response variable in the model was the natural-log transformed change in METH exposure parameters: Cmax. The model contained fixed effects for treatment, day (categorical day postdose), natural-log transformed Day 1 baseline parameter and a treatment-by-day interaction, and a random effect for subject.|||||<|0.0001||||||Geometric LS Means Ratios of change in METH exposure for IXT-m200 compared to Placebo on Day 5 (primary). Threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Values were compared by a statistical analysis of change from Day 1 in METH PK parameters following IXT-m200 dosing. Geometric LS Mean change from Day 1 for each treatment on each day were calculated. Geometric LS Means Ratios of change in METH exposure for each dose level of IXT-m200 compared to Placebo on each Day 5 (primary), Day 12, Day 19 and Day 26 were calculated along with the 95% confidence intervals.||||<0.0001
72617583|NCT03336866|144766319|OTHER|The effect of IXT-m200 on METH exposure was evaluated with a linear mixed effects model. The response variable in the model was the natural-log transformed change in METH exposure parameters: Cmax. The model contained fixed effects for treatment, day (categorical day postdose), natural-log transformed Day 1 baseline parameter and a treatment-by-day interaction, and a random effect for subject.|||||<|0.0001||||||Geometric LS Means Ratios of change in METH exposure for IXT-m200 compared to Placebo on Day 12. Threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Values were compared by a statistical analysis of change from Day 1 in METH PK parameters following IXT-m200 dosing. Geometric LS Mean change from Day 1 for each treatment on each day were calculated. Geometric LS Means Ratios of change in METH exposure for each dose level of IXT-m200 compared to Placebo on each Day 5 (primary), Day 12, Day 19 and Day 26 were calculated along with the 95% confidence intervals.||||<0.0001
72617584|NCT03336866|144766319|OTHER|The effect of IXT-m200 on METH exposure was evaluated with a linear mixed effects model. The response variable in the model was the natural-log transformed change in METH exposure parameters: Cmax. The model contained fixed effects for treatment, day (categorical day postdose), natural-log transformed Day 1 baseline parameter and a treatment-by-day interaction, and a random effect for subject.|||||<|0.0001||||||Geometric LS Means Ratios of change in METH exposure for IXT-m200 compared to Placebo on Day 19. Threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Values were compared by a statistical analysis of change from Day 1 in METH PK parameters following IXT-m200 dosing. Geometric LS Mean change from Day 1 for each treatment on each day were calculated. Geometric LS Means Ratios of change in METH exposure for each dose level of IXT-m200 compared to Placebo on each Day 5 (primary), Day 12, Day 19 and Day 26 were calculated along with the 95% confidence intervals.||||<0.0001
72617585|NCT03336866|144766319|OTHER|The effect of IXT-m200 on METH exposure was evaluated with a linear mixed effects model. The response variable in the model was the natural-log transformed change in METH exposure parameters: Cmax. The model contained fixed effects for treatment, day (categorical day postdose), natural-log transformed Day 1 baseline parameter and a treatment-by-day interaction, and a random effect for subject.|||||<|0.0001||||||Geometric LS Means Ratios of change in METH exposure for IXT-m200 compared to Placebo on Day 26. Threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Values were compared by a statistical analysis of change from Day 1 in METH PK parameters following IXT-m200 dosing. Geometric LS Mean change from Day 1 for each treatment on each day were calculated. Geometric LS Means Ratios of change in METH exposure for each dose level of IXT-m200 compared to Placebo on each Day 5 (primary), Day 12, Day 19 and Day 26 were calculated along with the 95% confidence intervals.||||<0.0001
72617586|NCT03336866|144766319|OTHER|The effect of IXT-m200 on METH exposure was evaluated with a linear mixed effects model. The response variable in the model was the natural-log transformed change in METH exposure parameters: Cmax. The model contained fixed effects for treatment, day (categorical day postdose), natural-log transformed Day 1 baseline parameter and a treatment-by-day interaction, and a random effect for subject.|||||<|0.0001||||||Geometric LS Means Ratios of change in METH exposure for IXT-m200 compared to Placebo on Day 5 (primary). Threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Values were compared by a statistical analysis of change from Day 1 in METH PK parameters following IXT-m200 dosing. Geometric LS Mean change from Day 1 for each treatment on each day were calculated. Geometric LS Means Ratios of change in METH exposure for each dose level of IXT-m200 compared to Placebo on each Day 5 (primary), Day 12, Day 19 and Day 26 were calculated along with the 95% confidence intervals.||||<0.0001
72617587|NCT03336866|144766319|OTHER|The effect of IXT-m200 on METH exposure was evaluated with a linear mixed effects model. The response variable in the model was the natural-log transformed change in METH exposure parameters: Cmax. The model contained fixed effects for treatment, day (categorical day postdose), natural-log transformed Day 1 baseline parameter and a treatment-by-day interaction, and a random effect for subject.|||||<|0.0001||||||Geometric LS Means Ratios of change in METH exposure for IXT-m200 compared to Placebo on Day 12. Threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Values were compared by a statistical analysis of change from Day 1 in METH PK parameters following IXT-m200 dosing. Geometric LS Mean change from Day 1 for each treatment on each day were calculated. Geometric LS Means Ratios of change in METH exposure for each dose level of IXT-m200 compared to Placebo on each Day 5 (primary), Day 12, Day 19 and Day 26 were calculated along with the 95% confidence intervals.||||<0.0001
72622306|NCT04250207|144774537|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.|||||<|0.0001|||||||Chi-square or Fisher exact|||Week 12||||< 0.0001
72622307|NCT04250207|144774537|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.||||||0.0028|||||||Chi-square or Fisher exact|||Week 12||||0.0028
72371620|NCT00669409|144253450|SUPERIORITY_OR_OTHER_LEGACY||Least Mean Square Difference|-4.2|STANDARD_ERROR_OF_MEAN|8.25|||TWO_SIDED|95.0|-20.5|12.1||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||12.1|-20.5|
72371621|NCT00669409|144253450|SUPERIORITY_OR_OTHER_LEGACY||Least Mean Square Difference|-15.8|STANDARD_ERROR_OF_MEAN|8.14|||TWO_SIDED|95.0|-31.9|0.3||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||0.3|-31.9|
72617588|NCT03336866|144766319|OTHER|The effect of IXT-m200 on METH exposure was evaluated with a linear mixed effects model. The response variable in the model was the natural-log transformed change in METH exposure parameters: Cmax. The model contained fixed effects for treatment, day (categorical day postdose), natural-log transformed Day 1 baseline parameter and a treatment-by-day interaction, and a random effect for subject.|||||<|0.0001||||||Geometric LS Means Ratios of change in METH exposure for IXT-m200 compared to Placebo on Day 19. Threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Values were compared by a statistical analysis of change from Day 1 in METH PK parameters following IXT-m200 dosing. Geometric LS Mean change from Day 1 for each treatment on each day were calculated. Geometric LS Means Ratios of change in METH exposure for each dose level of IXT-m200 compared to Placebo on each Day 5 (primary), Day 12, Day 19 and Day 26 were calculated along with the 95% confidence intervals.||||<0.0001
72617589|NCT00541775|144766330|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.51|STANDARD_ERROR_OF_MEAN|0.1|<=|0.001||95.0|-0.7|-0.32|||ANCOVA|Analysis of covariance with a term for treatment, and a covariate for baseline value.||||-0.32|-0.70|<=0.001
72617590|NCT00541775|144766331|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-17.8|STANDARD_ERROR_OF_MEAN|5.0|<=|0.001||95.0|-27.6|-8.1|||ANCOVA|Analysis of covariance with a term for treatment, and a covariate for baseline value.||||-8.1|-27.6|<=0.001
72617591|NCT00541775|144766332|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-30.5|STANDARD_ERROR_OF_MEAN|7.9|<=|0.001||95.0|-46.0|-15.0|||ANCOVA|Analysis of covariance with a term for treatment, and a covariate for baseline value.||||-15.0|-46.0|<=0.001
72617592|NCT00032487|144766333|NON_INFERIORITY_OR_EQUIVALENCE|The statistical analysis tested was for equivalence. We assumed 86% power with 21% of effect size and the sample size 1700 with 5% drop out rate.|Cox Proportional Hazard|0.79|||<|0.05|TWO_SIDED|95.0|0.79|0.99|||Log Rank|||It was hypothesized 21% reduction in intensive glycemic control group compared to standard control group on primary cardiovascular composite outcomes.||.99|.79|<0.05
72617593|NCT02547935|144766368|SUPERIORITY||Difference in adjusted mean change|-0.58|STANDARD_ERROR_OF_MEAN|0.11|<|0.001|TWO_SIDED|95.0|-0.8|-0.37||Statistical significance level = 0.025.|MMRM|||A longitudinal repeated measures analysis included the fixed categorical effects of treatment, week, randomisation stratification factor (i.e. anti-diabetic treatment strata), and treatment-by-week interaction, as well as the continuous fixed covariates of baseline measurement and baseline measurement-by-week interaction.||-0.37|-0.80|<0.001
72617594|NCT02547935|144766369|SUPERIORITY||Difference in adjusted mean change|-38.0|STANDARD_ERROR_OF_MEAN|5.7|<|0.001|TWO_SIDED|95.0|-48.2|-25.8||Statistical significance level = 0.025.|MMRM|||A longitudinal repeated measures model of the logarithms of the post-baseline to baseline ratios included the fixed categorical effects of treatment, week, treatment-by-week interaction, and randomisation stratification factor (i.e. anti-diabetic treatment strata), as well as the continuous fixed covariates of log-baseline UACR value and log-baseline UACR value-by-week interaction.||-25.8|-48.2|<0.001
72617595|NCT02547935|144766369|SUPERIORITY||Difference in adjusted mean change|-21.0|STANDARD_ERROR_OF_MEAN|7.3||0.011|TWO_SIDED|95.0|-34.1|-5.2||Statistical significance level = 0.025.|MMRM|||A longitudinal repeated measures model of the logarithms of the post-baseline to baseline ratios included the fixed categorical effects of treatment, week, treatment-by-week interaction, and randomisation stratification factor (i.e. anti-diabetic treatment strata), as well as the continuous fixed covariates of log-baseline UACR value and log-baseline UACR value-by-week interaction.||-5.2|-34.1|0.011
72617596|NCT02547935|144766370|SUPERIORITY||Difference in adjusted mean change|-0.04|STANDARD_ERROR_OF_MEAN|0.66||0.953|TWO_SIDED|95.0|-1.32|1.26||Statistical significance level = 0.025.|MMRM|||A longitudinal repeated measures model of the logarithms of the post-baseline to baseline ratios included the fixed categorical effects of treatment, week, treatment-by-week interaction, and randomisation stratification factor (i.e. anti-diabetic treatment strata), as well as the continuous fixed covariates of log-baseline total body weight value and log-baseline total body weight value-by-week interaction.||1.26|-1.32|0.953
72617597|NCT02547935|144766370|SUPERIORITY||Difference in adjusted mean change|-0.87|STANDARD_ERROR_OF_MEAN|0.66||0.193|TWO_SIDED|95.0|-2.17|0.44||Statistical significance level = 0.025.|MMRM|||A longitudinal repeated measures model of the logarithms of the post-baseline to baseline ratios included the fixed categorical effects of treatment, week, treatment-by-week interaction, and randomisation stratification factor (i.e. anti-diabetic treatment strata), as well as the continuous fixed covariates of log-baseline total body weight value and log-baseline total body weight value-by-week interaction.||0.44|-2.17|0.193
72617598|NCT02547935|144766371|SUPERIORITY||Difference in adjusted mean change|-6.1|STANDARD_ERROR_OF_MEAN|5.8||0.298|TWO_SIDED|95.0|-17.5|5.4||Statistical significance level = 0.025.|MMRM|||A longitudinal repeated measures analysis included the fixed categorical effects of treatment, week, randomisation stratification factor (i.e.anti-diabetic treatment strata), and treatment-by-week interaction, as well as the continuous fixed covariates of baseline measurement and baseline measurement-by-week interaction.||5.4|-17.5|0.298
72617599|NCT02547935|144766371|SUPERIORITY||Difference in adjusted mean change|-1.9|STANDARD_ERROR_OF_MEAN|5.9||0.746|TWO_SIDED|95.0|-13.6|9.8||Statistical significance level = 0.025.|MMRM|||A longitudinal repeated measures analysis included the fixed categorical effects of treatment, week, randomisation stratification factor (i.e.anti-diabetic treatment strata), and treatment-by-week interaction, as well as the continuous fixed covariates of baseline measurement and baseline measurement-by-week interaction.||9.8|-13.6|0.746
72617600|NCT02547935|144766372|SUPERIORITY||Odds Ratio (OR)|2.98|||<|0.001|TWO_SIDED|95.0|1.8|4.8||Statistical significance level = 0.025.|Regression, Logistic|||Logistic regression model analysis with adjustment for baseline UACR and pooled randomisation strata.||4.8|1.8|<0.001
72617601|NCT02547935|144766372|SUPERIORITY||Odds Ratio (OR)|1.86||||0.013|TWO_SIDED|95.0|1.1|3.0||Statistical significance level = 0.025.|Regression, Logistic|||Logistic regression model analysis with adjustment for baseline UACR and pooled randomisation strata.||3.0|1.1|0.013
72617602|NCT02547935|144766373|SUPERIORITY||Odds Ratio (OR)|5.43|||<|0.001|TWO_SIDED|95.0|2.6|11.2||Statistical significance level = 0.025.|Regression, Logistic|||Logistic regression model analysis with adjustment for baseline HbA1c and pooled randomisation strata.||11.2|2.6|<0.001
72617603|NCT02547935|144766373|SUPERIORITY||Odds Ratio (OR)|1.74||||0.167|TWO_SIDED|95.0|0.8|3.8||Statistical significance level = 0.025.|Regression, Logistic|||Logistic regression model analysis with adjustment for baseline HbA1c and pooled randomisation strata.||3.8|0.8|0.167
72617604|NCT02547935|144766374|SUPERIORITY||Difference in adjusted mean change|-4.8|STANDARD_ERROR_OF_MEAN|1.8||0.009|TWO_SIDED|95.0|-8.3|-1.2||Statistical significance level = 0.025.|MMRM|||A longitudinal repeated measures model of the logarithms of the post-baseline to baseline ratios, included the fixed categorical effects of treatment, week, treatment-by-week interaction, and randomisation strata, as well as the continuous fixed covariates of log-baseline SBP value and log-baseline SBP value-by-week interaction.||-1.2|-8.3|0.009
72617605|NCT02547935|144766374|SUPERIORITY||Difference in adjusted mean change|-2.8|STANDARD_ERROR_OF_MEAN|1.8||0.122|TWO_SIDED|95.0|-6.4|0.8||Statistical significance level = 0.025.|MMRM|||A longitudinal repeated measures model of the logarithms of the post-baseline to baseline ratios, included the fixed categorical effects of treatment, week, treatment-by-week interaction, and randomisation strata, as well as the continuous fixed covariates of log-baseline SBP value and log-baseline SBP value-by-week interaction.||0.8|-6.4|0.122
72617606|NCT02547935|144766375|SUPERIORITY||Difference in adjusted mean change|-0.16|STANDARD_ERROR_OF_MEAN|0.11||0.142|TWO_SIDED|95.0|-0.38|0.05||Statistical significance level = 0.025.|MMRM|||A longitudinal repeated measures analysis included the fixed categorical effects of treatment, week, randomisation stratification factor (i.e. anti-diabetic treatment strata), and treatment-by-week interaction, as well as the continuous fixed covariates of baseline measurement and baseline measurement-by-week interaction.||0.05|-0.38|0.142
72617607|NCT03461861|144766376|SUPERIORITY||Median Difference (Final Values)|-0.083|STANDARD_DEVIATION|0.0056||0.007567|TWO_SIDED|95.0|-0.0886|-0.0774|||t-test, 2 sided|||The null hypothesis (H0) of this superiority trials asserts that there is no true difference in functional connectivity between the interventions of placebo and AGB101, and the alternative hypothesis (H1) states that there is a difference between the interventions of placebo and AGB101. A type I error is the error of rejecting H0 when it is actually true.||-0.0774|-0.0886|0.007567
72617608|NCT03461861|144766377|SUPERIORITY||Mean Difference (Final Values)|3.12|STANDARD_DEVIATION|1.4||0.900593|TWO_SIDED|95.0|1.72|4.52|||t-test, 2 sided|||The null hypothesis (H0) of this trial asserts that there is no true difference in AVLT between the interventions of placebo and AGB101, and the alternative hypothesis (H1) states that there is a difference between the interventions of placebo and AGB101. A type I error is the error of rejecting H0 when it is actually true.||4.52|1.72|0.900593
72617609|NCT05675020|144766384|OTHER|The descriptive analysis yields frequencies and percentages for categorical variables. The statistical analysis was conducted using IBM SPSS V27.0. We analyzed the percentage of correct responses for knowledge survey questions from pre- and post-intervention survey responses.|||||||||||||||||Participant data was collected from the REDCap pre- and post-intervention questionnaires completed by the adolescents and parents/legal guardians that participated in the project. Data was collected from October to December 2022. The sample size was nine parent-adolescent dyads. Descriptive analysis was used to assess differences in sociodemographic variables, including age, gender, race, material status, employment status, salary, height, and weight. The descriptive analysis yields frequencies and percentages for categorical variables. The statistical analysis was conducted using IBM SPSS V27.0.|||
72617610|NCT02014103|144766386|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Accord/Astellas Ratio X 100|115.78|||||TWO_SIDED|90.0|107.04|125.22|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed AUC 0-12 parameters||125.22|107.04|
72617611|NCT02014103|144766386|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Dr. Reddys/Astellas Ratio|103.7|||||TWO_SIDED|90.0|95.91|112.12|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed AUC 0-12 parameters||112.12|95.91|
72617612|NCT02014103|144766386|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Mylan/Astellas Ratio X 100|99.79|||||TWO_SIDED|90.0|92.3|107.89|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed AUC 0-12 parameters||107.89|92.30|
72617613|NCT02014103|144766386|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Panacea/Astellas Ratio|103.65|||||TWO_SIDED|90.0|95.83|112.11|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed AUC 0-12 and Cmax parameters||112.11|95.83|
72617614|NCT02014103|144766386|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Sandoz/Astellas Ratio X100|101.7|||||TWO_SIDED|90.0|94.03|110.0|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed AUC 0-12 and parameters||110.0|94.03|
72617615|NCT02014103|144766386|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Accord/Dr Reddys Ratio X 100|111.64|||||TWO_SIDED|90.0|103.26|120.7|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed AUC 0-12 parameters||120.70|103.26|
72617616|NCT02014103|144766386|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Accord/Mylan Ratio X 100|116.02|||||TWO_SIDED|90.0|107.27|125.49|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed AUC 0-12 parameters||125.49|107.27|
72617617|NCT02014103|144766386|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Accord/Panacea Ratio X 100|111.7|||||TWO_SIDED|90.0|103.27|120.81|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed AUC 0-12 parameters||120.81|103.27|
72617618|NCT02014103|144766386|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Accord/Sandoz Ratio X 100|113.84|||||TWO_SIDED|90.0|105.3|123.08|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed AUC 0-12 parameters||123.08|105.30|
72617619|NCT02014103|144766386|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Dr Reddys/Mylan Ratio X 100|103.92|||||TWO_SIDED|90.0|96.08|112.4|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed AUC 0-12 parameters||112.40|96.08|
72617620|NCT02014103|144766386|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Dr Reddys/Panacea Ratio x 100|100.05|||||TWO_SIDED|90.0|92.5|108.21|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed AUC 0-12 parameters||108.21|92.50|
72617621|NCT02014103|144766386|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Dr Reddys/Sandoz Ratio X 100|101.97|||||TWO_SIDED|90.0|94.28|110.29|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed AUC 0-12 parameters||110.29|94.28|
72617622|NCT02014103|144766386|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Mylan/Panacea Ratio X 100|96.28|||||TWO_SIDED|90.0|89.05|104.09|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed AUC 0-12 parameters||104.09|89.05|
72617623|NCT02014103|144766386|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Mylan/Sandoz Ratio X 100|98.12|||||TWO_SIDED|90.0|90.72|106.12|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed AUC 0-12 parameters||106.12|90.72|
72617624|NCT02014103|144766386|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Panacea/Sandoz Ratio X 100|101.92|||||TWO_SIDED|90.0|94.27|110.19|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed AUC 0-12 parameters||110.19|94.27|
72617625|NCT02014103|144766386|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Accord/Astellas Ratio X 100|109.75|||||TWO_SIDED|90.0|100.42|119.25|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed AUC 0-12 parameters||119.25|100.42|
72617626|NCT02014103|144766386|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Dr Reddys/Astellas Ratio X 100|99.76|||||TWO_SIDED|90.0|91.28|109.03|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed AUC 0-12 parameters||109.03|91.28|
72617627|NCT02014103|144766386|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Mylan/Astellas Ratio X 100|101.63|||||TWO_SIDED|90.0|92.99|111.06|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed AUC 0-12 parameters||111.06|92.99|
72371622|NCT00669409|144253450|SUPERIORITY_OR_OTHER_LEGACY||Least Mean Square Difference|-35.1|STANDARD_ERROR_OF_MEAN|10.75|||TWO_SIDED|95.0|-56.4|-13.8||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-13.8|-56.4|
72617628|NCT02014103|144766386|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Panacea/Astellas Ratio X 100|106.2|||||TWO_SIDED|90.0|97.17|116.06|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed AUC 0-12 parameters||116.06|97.17|
72617629|NCT02014103|144766386|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Sandoz/Astellas Ratio X 100|104.09|||||TWO_SIDED|90.0|95.25|113.75|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed AUC 0-12 parameters||113.75|95.25|
72617630|NCT02014103|144766386|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Accord/Dr Reddy Ratio X 100|110.02|||||TWO_SIDED|90.0|100.66|120.24|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed AUC 0-12 parameters||120.24|100.66|
72617631|NCT02014103|144766386|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Accord/Mylan Ratio X 100|108.0|||||TWO_SIDED|90.0|98.82|118.02|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed AUC 0-12 parameters||118.02|98.82|
72617632|NCT02014103|144766386|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Accord/Panacea Ratio X 100|103.34|||||TWO_SIDED|90.0|94.56|112.94|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed AUC 0-12 parameters||112.94|94.56|
72617633|NCT02014103|144766386|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Accord/Sandoz Ratio X 100|105.44|||||TWO_SIDED|90.0|96.48|115.23|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed AUC 0-12 parameters||115.23|96.48|
72617634|NCT02014103|144766386|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Dr Reddys/Mylan Ration X 100|98.16|||||TWO_SIDED|90.0|89.82|107.28|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed AUC 0-12 parameters||107.28|89.82|
72617635|NCT02014103|144766386|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Dr. Reddys/Panacea Ratio X 100|93.93|||||TWO_SIDED|90.0|85.96|102.65|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed AUC 0-12 parameters||102.65|85.96|
72617636|NCT02014103|144766386|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Dr Reddys/Sandoz Ratio X 100|95.84|||||TWO_SIDED|90.0|87.69|104.74|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed AUC 0-12 parameters||104.74|87.69|
72617637|NCT02014103|144766386|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Mylan/Panacea Ratio X 100|95.69|||||TWO_SIDED|90.0|87.56|104.58|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed AUC 0-12 parameters||104.58|87.56|
72617638|NCT02014103|144766386|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Mylan/Sandoz Ratio X 100|97.63|||||TWO_SIDED|90.0|89.34|107.71|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed AUC 0-12 parameters||107.71|89.34|
72617639|NCT02014103|144766386|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Pancea/Sandoz Ratio X 100|102.03|||||TWO_SIDED|90.0|93.36|111.51|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed AUC 0-12 parameters||111.51|93.36|
72617640|NCT02014103|144766387|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Accord/Astellas Ratio X 100|141.91|||||TWO_SIDED|90.0|125.73|160.16|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed Cmax parameters||160.16|125.73|
72617641|NCT02014103|144766387|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Dr Reddys/Astellas Ratio X 100|104.13|||||TWO_SIDED|90.0|92.33|117.45|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed Cmax parameters||117.45|92.33|
72617642|NCT02014103|144766387|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Mylan/Astellas Ratio X 100|116.02|||||TWO_SIDED|90.0|102.87|130.87|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed Cmax parameters||130.87|102.87|
72617643|NCT02014103|144766387|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Panacea/Astellas Ratio X 100|108.92|||||TWO_SIDED|90.0|96.51|122.94|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed Cmax parameters||122.94|96.51|
72617644|NCT02014103|144766387|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Sandoz/Astellas Ratio X 100|94.06|||||TWO_SIDED|90.0|83.33|106.16|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed Cmax parameters||106.16|83.33|
72371623|NCT00669409|144253451|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-4.7|STANDARD_ERROR_OF_MEAN|8.33|||TWO_SIDED|95.0|-21.2|11.8||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||11.8|-21.2|
72617645|NCT02014103|144766387|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Accord/Dr. Reddys Ratio X 100|136.27|||||TWO_SIDED|90.0|120.82|153.7|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed Cmax parameters||153.70|120.82|
72617646|NCT02014103|144766387|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Accord/Mylan Ratio X 100|122.31|||||TWO_SIDED|90.0|108.37|138.04|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed Cmax parameters||138.04|108.37|
72617647|NCT02014103|144766387|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Accord/Panacea Ratio X 100|130.28|||||TWO_SIDED|90.0|115.43|147.04|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed Cmax parameters||147.04|115.43|
72617648|NCT02014103|144766387|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Accord/Sandoz Ratio X 100|150.88|||||TWO_SIDED|90.0|133.77|170.18|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed Cmax parameters||170.18|133.77|
72617649|NCT02014103|144766387|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Dr. Reddys/Mylan Ratio X 100|89.75|||||TWO_SIDED|90.0|79.52|101.3|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed Cmax parameters||101.30|79.52|
72432392|NCT02696785|144377179|SUPERIORITY||LSMean Difference|-5.47|STANDARD_ERROR_OF_MEAN|3.27||0.096|TWO_SIDED|95.0|-11.92|0.98|||Mixed Models Analysis|||||0.98|-11.92|0.096
72617650|NCT02014103|144766387|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Dr Reddys/Panacea Ratio X 100|95.6|||||TWO_SIDED|90.0|84.71|107.9|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed Cmax parameters||107.90|84.71|
72617651|NCT02014103|144766387|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Dr Reddys/Sandoz Ratio X 100|110.72|||||TWO_SIDED|90.0|98.1|124.96|||||Bioequivalence is established when 90% confidence interval falls within 80-125|||124.96|98.10|
72617652|NCT02014103|144766387|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Mylan/Panacea Ratio X 100|106.52|||||TWO_SIDED|90.0|94.44|120.15|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed Cmax parameters||120.15|94.44|
72617653|NCT02014103|144766387|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Mylan/Sandoz Ratio X 100|123.36|||||TWO_SIDED|90.0|109.3|139.23|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed Cmax parameters||139.23|109.30|
72617654|NCT02014103|144766387|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Panacea/Sandoz Ratio X 100|115.81|||||TWO_SIDED|90.0|102.68|130.62|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed Cmax parameters||130.62|102.68|
72617655|NCT02014103|144766387|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Accord/Astellas Ratio X 100|112.96|||||TWO_SIDED|90.0|100.32|127.2|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed Cmax parameters||127.20|100.32|
72617656|NCT02014103|144766387|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Dr Reddys/Astellas Ratio X 100|101.75|||||TWO_SIDED|90.0|90.37|114.57|||||Bioequivalence is established when 90% confidence interval falls within 80-125|||114.57|90.37|
72371624|NCT00669409|144253451|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-16.7|STANDARD_ERROR_OF_MEAN|8.25|||TWO_SIDED|95.0|-33.0|-0.4||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-0.4|-33.0|
72617657|NCT02014103|144766387|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Mylan/Astella Ratio X 100|113.52|||||TWO_SIDED|90.0|100.82|127.83|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed Cmax parameters||127.83|100.82|
72617658|NCT02014103|144766387|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Panacea/Astellas Ratio X 100|99.16|||||TWO_SIDED|90.0|88.06|111.64|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed Cmax parameters||111.64|88.06|
72617659|NCT02014103|144766387|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Sandoz/Astellas Ratio X 100|95.57|||||TWO_SIDED|90.0|84.89|107.61|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed Cmax parameters||107.61|84.89|
72371625|NCT00669409|144253451|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|2.8|STANDARD_ERROR_OF_MEAN|8.25|||TWO_SIDED|95.0|-13.5|19.1||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||19.1|-13.5|
72371626|NCT00669409|144253451|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-13.1|STANDARD_ERROR_OF_MEAN|8.14|||TWO_SIDED|95.0|-29.2|3.0||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||3.0|-29.2|
72617660|NCT02014103|144766387|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Accord/Dr Reddy Ratio X 100|111.01|||||TWO_SIDED|90.0|98.59|125.0|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed Cmax parameters||125.00|98.59|
72617661|NCT02014103|144766387|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Accord/Mylan Ratio X 100|99.51|||||TWO_SIDED|90.0|88.38|112.04|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed Cmax parameters||112.04|88.38|
72617662|NCT02014103|144766387|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Accord/Panacea Ratio X 100|113.93|||||TWO_SIDED|90.0|101.18|128.28|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed Cmax parameters||128.28|101.18|
72617663|NCT02014103|144766387|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Accord/Sandoz Ratio X 100|118.19|||||TWO_SIDED|90.0|104.96|133.08|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed Cmax parameters||133.08|104.96|
72617664|NCT02014103|144766387|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Dr Reddys/Mylan|89.64|||||TWO_SIDED|90.0|79.61|100.93|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed Cmax parameters||100.93|79.61|
72617665|NCT02014103|144766387|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Dr. Reddys/Panacea Ratio X 100|102.63|||||TWO_SIDED|90.0|91.15|115.55|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed Cmax parameters||115.55|91.15|
72617666|NCT02014103|144766387|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Dr. Reddys/Sandoz Ratio X 100|106.46|||||TWO_SIDED|90.0|94.55|119.88|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed Cmax parameters||119.88|94.55|
72617667|NCT02014103|144766387|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Mylan/Panacea Ratio X 100|114.49|||||TWO_SIDED|90.0|110.68|128.92|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed Cmax parameters||128.92|110.68|
72617668|NCT02014103|144766387|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Mylan/Sandoz Ratio X 100|118.77|||||TWO_SIDED|90.0|105.48|133.74|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed Cmax parameters||133.74|105.48|
72617669|NCT02014103|144766387|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Panacea/Sandoz Ratio X 100|103.74|||||TWO_SIDED|90.0|92.13|116.81|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed Cmax parameters||116.81|92.13|
72617670|NCT05890586|144766434|SUPERIORITY|The posterior was based on a covariate adjusted Cox proportional hazards regression with skeptical prior. The baseline hazard was a degree 5 M-spline function.|Hazard Ratio (HR)|0.96|||||TWO_SIDED|95.0|0.86|1.07|||||Hazard ratios greater than one favored the active intervention for a faster time to recovery.|||1.07|0.86|
72617671|NCT05890586|144766435|SUPERIORITY|No hypothesis test or decision rule was evaluated.|Hazard Ratio (HR)|0.3|||||TWO_SIDED|95.0|0.03|2.88|||||Low event rate precluded covariate adjustment.|||2.88|0.03|
72617672|NCT05890586|144766438|SUPERIORITY|No hypothesis test or decision rule was evaluated.|Hazard Ratio (HR)|1.0|||||TWO_SIDED|95.0|0.6|1.7|||||Hazard ratios less than one favor the active intervention of inhaled fluticasone furoate. The interval is a highest density credible interval.|The posterior was based on a covariate adjusted Cox proportional hazards regression with skeptical prior. The baseline hazard was a degree 5 M-spline function.||1.7|0.6|
72617673|NCT05890586|144766439|SUPERIORITY|No hypothesis test or decision rule was evaluated.|Odds Ratio (OR)|1.32|||||TWO_SIDED|95.0|0.74|1.98|||||The interval is a highest-density credible interval on the log relative odds scale. Odds ratio estimate from a Bayesian cumulative probability ordinal regression model with weakly informative priors.|Adjustment variables are randomization assignment, age (as restricted cubic spline), sex, duration of symptoms prior to receipt of study drug, calendar time (as restricted cubic spline), vaccination status, geographic region (Northeast, Midwest, South, West), call center indicator, and baseline symptom severity.||1.98|0.74|
72617674|NCT05890586|144766440|SUPERIORITY|No hypothesis test or decision rule was evaluated.|Odds Ratio (OR)|1.22|||||TWO_SIDED|95.0|0.53|2.06|||||The interval is a highest-density credible interval on the log relative odds scale. Odds ratio estimate from a Bayesian cumulative probability ordinal regression model with weakly informative priors.|Adjustment variables are randomization assignment, age (as restricted cubic spline), sex, duration of symptoms prior to receipt of study drug, calendar time (as restricted cubic spline), vaccination status, geographic region (Northeast, Midwest, South, West), call center indicator, and baseline symptom severity.||2.06|0.53|
72617675|NCT05890586|144766441|SUPERIORITY|No hypothesis test or decision rule was evaluated.|Odds Ratio (OR)|1.45|||||TWO_SIDED|95.0|0.74|2.22|||||The interval is a highest-density credible interval on the log relative odds scale. Odds ratio estimate from a Bayesian cumulative probability ordinal regression model with weakly informative priors.|Adjustment variables are randomization assignment, age (as restricted cubic spline), sex, duration of symptoms prior to receipt of study drug, calendar time (as restricted cubic spline), vaccination status, geographic region (Northeast, Midwest, South, West), call center indicator, and baseline symptom severity.||2.22|0.74|
72617676|NCT05890586|144766442|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|0.65|||||TWO_SIDED|95.0|0.51|0.83|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 7||0.83|0.51|
72617677|NCT05890586|144766442|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|0.92|||||TWO_SIDED|95.0|0.7|1.21|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 14||1.21|0.70|
72617678|NCT05890586|144766442|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|0.75|||||TWO_SIDED|95.0|0.55|1.03|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 28||1.03|0.55|
72617679|NCT05890586|144766442|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|0.97|||||TWO_SIDED|95.0|0.68|1.39|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 90||1.39|0.68|
72617680|NCT05890586|144766443|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|1.29|||||TWO_SIDED|95.0|1.04|1.6|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 7||1.60|1.04|
72617681|NCT05890586|144766443|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|1.22|||||TWO_SIDED|95.0|0.98|1.51|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 14||1.51|0.98|
72617682|NCT05890586|144766443|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|1.07|||||TWO_SIDED|95.0|0.84|1.35|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 28||1.35|0.84|
72617683|NCT05890586|144766443|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|1.16|||||TWO_SIDED|95.0|0.92|1.47|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 90||1.47|0.92|
72617684|NCT05890586|144766444|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|1.02|||||TWO_SIDED|95.0|0.8|1.29|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 7||1.29|0.80|
72617685|NCT05890586|144766444|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|1.11|||||TWO_SIDED|95.0|0.84|1.47|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 14||1.47|0.84|
72617686|NCT05890586|144766444|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|1.08|||||TWO_SIDED|95.0|0.8|1.46|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 28||1.46|0.80|
72617687|NCT05890586|144766444|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|1.05|||||TWO_SIDED|95.0|0.77|1.44|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 90||1.44|0.77|
72617688|NCT05890586|144766445|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|0.9|||||TWO_SIDED|95.0|0.7|1.16|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 7||1.16|0.70|
72617689|NCT05890586|144766445|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|0.83|||||TWO_SIDED|95.0|0.63|1.1|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 14||1.10|0.63|
72617690|NCT05890586|144766445|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|0.73|||||TWO_SIDED|95.0|0.54|0.99|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 28||0.99|0.54|
72617691|NCT05890586|144766445|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|0.88|||||TWO_SIDED|95.0|0.66|1.18|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 90||1.18|0.66|
72617692|NCT05890586|144766446|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|1.08|||||TWO_SIDED|95.0|0.85|1.37|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 7||1.37|0.85|
72617693|NCT05890586|144766446|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|1.11|||||TWO_SIDED|95.0|0.85|1.44|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 14||1.44|0.85|
72617694|NCT05890586|144766446|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|0.93|||||TWO_SIDED|95.0|0.7|1.24|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 28||1.24|0.70|
72617695|NCT05890586|144766446|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|1.03|||||TWO_SIDED|95.0|0.78|1.37|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 90||1.37|0.78|
72617696|NCT05890586|144766447|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|0.84|||||TWO_SIDED|95.0|0.68|1.05|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 7||1.05|0.68|
72617697|NCT05890586|144766447|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|0.88|||||TWO_SIDED|95.0|0.7|1.11|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 14||1.11|0.70|
72617698|NCT05890586|144766447|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|0.93|||||TWO_SIDED|95.0|0.72|1.21|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 28||1.21|0.72|
72617699|NCT05890586|144766447|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|0.98|||||TWO_SIDED|95.0|0.75|1.29|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 90||1.29|0.75|
72617700|NCT05890586|144766448|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio, log|1.3|||||TWO_SIDED|95.0|1.05|1.6|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 7||1.60|1.05|
72617701|NCT05890586|144766448|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|1.23|||||TWO_SIDED|95.0|1.0|1.52|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 14||1.52|1.00|
72617702|NCT05890586|144766448|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|1.04|||||TWO_SIDED|95.0|0.84|1.27|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 28||1.27|0.84|
72617703|NCT05890586|144766448|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|0.98|||||TWO_SIDED|95.0|0.8|1.21|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 90||1.21|0.80|
72617704|NCT05890586|144766449|SUPERIORITY||Difference in model estimate time unwell|-0.07|||||TWO_SIDED|95.0|-0.43|0.31|||||The interval is a highest-density credible interval.|Analysis is exploratory. No hypothesis test or decision rule was evaluated.||0.31|-0.43|
72617705|NCT05890586|144766450|SUPERIORITY||Difference in model estimated means|0.08|||||TWO_SIDED|95.0|-0.37|0.52|||||The interval is a highest-density credible interval.|Analysis is exploratory. No hypothesis test or decision rule was evaluated.||0.52|-0.37|
72617706|NCT01245751|144766471|NON_INFERIORITY_OR_EQUIVALENCE|Week 6 GMT value for Group 1 is statistically non-inferior to Group 2 for the prespecified clinically relevant 1.5-fold ratio if the lower bound of the 95% confidence interval for the GMT ratio is \>0.67|GMT Ratio|1.05|||<|0.001|TWO_SIDED|95.0|0.97|1.15||The alpha threshold for statistical significance is 0.025 (1-sided)|Longitudinal regression model|The analyzed GMT ratio, 95% confidence interval, and P-value were based on a longitudinal regression model adjusting for age and vaccination group||Week 6 analysis||1.15|0.97|<0.001
72617707|NCT01245751|144766472|SUPERIORITY_OR_OTHER||Geometric mean fold rise|1.54|||<|0.001|TWO_SIDED|95.0|1.44|1.66||The alpha threshold for statistical significance is 0.025 (1-sided)|Longitudinal regression model|The analyzed GMFR, 95% confidence interval, and P-value were based on a longitudinal regression model adjusting for age||A booster dose induces a statistically acceptable VZV antibody response if the lower bound of the 95% confidence interval is \>1.0.||1.66|1.44|<0.001
72617708|NCT05788328|144766474|OTHER||Ratio of Adjusted Geometric Means|86.5|||||TWO_SIDED|90.0|66.05|113.29|||||Ratio was of test to reference of adjusted geometric means. Reference arm was DE 150mg (Period 1) and test arm was PF-07081532 80mg QD + DE 150mg (Period 4). Ratios (and 90% CIs) were expressed as percentages.|Analysis was performed using mixed effect model with treatment as a fixed effect and participant as a random effect.||113.29|66.05|
72617709|NCT05788328|144766474|OTHER||Ratio of Adjusted Geometric Means|82.64|||||TWO_SIDED|90.0|63.1|108.24|||||Ratio was of test to reference of adjusted geometric means. Reference arm was DE 150mg (Period 1) and test arm was PF-07081532 240mg QD + DE 150mg (Period 7). Ratios (and 90% CIs) were expressed as percentages.|Analysis was performed using mixed effect model with treatment as a fixed effect and participant as a random effect.||108.24|63.10|
72617710|NCT05788328|144766475|OTHER||Ratio of Adjusted Geometric Means|85.65|||||TWO_SIDED|90.0|64.96|112.94|||||Ratio was of test to reference of adjusted geometric means. Reference arm was DE 150mg (Period 1) and test arm was PF-07081532 80mg QD + DE 150mg (Period 4). Ratios (and 90% CIs) were expressed as percentages.|Analysis was performed using mixed effect model with treatment as a fixed effect and participant as a random effect.||112.94|64.96|
72617711|NCT05788328|144766475|OTHER||Ratio of Adjusted Geometric Means|80.81|||||TWO_SIDED|90.0|61.28|106.55|||||Ratio was of test to reference of adjusted geometric means. Reference arm was DE 150mg (Period 1) and test arm was PF-07081532 240mg QD + DE 150mg (Period 7). Ratios (and 90% CIs) were expressed as percentages.|Analysis was performed using mixed effect model with treatment as a fixed effect and participant as a random effect.||106.55|61.28|
72617712|NCT05788328|144766476|OTHER||Ratio of Adjusted Geometric Means|229.11|||||TWO_SIDED|90.0|185.23|283.37|||||Ratio was of test to reference of adjusted geometric means. The reference arm was rosuvastatin 10 mg (Period 2) and test arm was PF-07081532 80 mg QD+rosuvastatin 10 mg (Period 5). The ratios (and 90% CIs) were expressed as percentages.|Analysis was performed using mixed effect model with treatment as a fixed effect and participant as a random effect.||283.37|185.23|
72617713|NCT05788328|144766476|OTHER||Ratio of Adjusted Geometric Means|214.73|||||TWO_SIDED|90.0|173.38|265.94|||||Ratio was of test to reference of adjusted geometric means. The reference arm was rosuvastatin 10 mg (Period 2) and test arm was PF-07081532 240 mg QD+rosuvastatin 10 mg (Period 8). The ratios (and 90% CIs) were expressed as percentages.|Analysis was performed using mixed effect model with treatment as a fixed effect and participant as a random effect.||265.94|173.38|
72617714|NCT05788328|144766477|OTHER||Ratio of Adjusted Geometric Means|213.05|||||TWO_SIDED|90.0|170.46|266.29|||||Ratio was of test to reference of adjusted geometric means. The reference arm was rosuvastatin 10 mg (Period 2) and test arm was PF-07081532 80 mg QD+rosuvastatin 10 mg (Period 5). The ratios (and 90% CIs) were expressed as percentages.|Analysis was performed using mixed effect model with treatment as a fixed effect and participant as a random effect.||266.29|170.46|
72617715|NCT05788328|144766477|OTHER||Ratio of Adjusted Geometric Means|232.32|||||TWO_SIDED|90.0|185.88|290.38|||||Ratio was of test to reference of adjusted geometric means. The reference arm was rosuvastatin 10 mg (Period 2) and test arm was PF-07081532 240 mg QD+rosuvastatin 10 mg (Period 8). The ratios (and 90% CIs) were expressed as percentages.|Analysis was performed using mixed effect model with treatment as a fixed effect and participant as a random effect.||290.38|185.88|
72617716|NCT05788328|144766485|OTHER||Ratio of Adjusted Geometric Means|45.25|||||TWO_SIDED|90.0|33.97|60.27|||||Ratio was of test to reference of adjusted geometric means. Reference arm was DE 150mg (Period 1) and test arm was PF-07081532 80mg QD + DE 150mg (Period 4). Ratios (and 90% CIs) were expressed as percentages.|Analysis was performed using mixed effect model with treatment as a fixed effect and participant as a random effect.||60.27|33.97|
72617717|NCT05788328|144766485|OTHER||Ratio of Adjusted Geometric Means|47.44|||||TWO_SIDED|90.0|35.62|63.19|||||Ratio was of test to reference of adjusted geometric means. Reference arm was DE 150mg (Period 1) and test arm was PF-07081532 240mg QD + DE 150mg (Period 7). Ratios (and 90% CIs) were expressed as percentages.|Analysis was performed using mixed effect model with treatment as a fixed effect and participant as a random effect.||63.19|35.62|
72617718|NCT05788328|144766490|OTHER||Ratio of Adjusted Geometric Means|176.39|||||TWO_SIDED|90.0|135.51|229.6|||||Ratio was of test to reference of adjusted geometric means. The reference arm was rosuvastatin 10 mg (Period 2) and test arm was PF-07081532 80 mg QD+rosuvastatin 10 mg (Period 5). The ratios (and 90% CIs) were expressed as percentages.|Analysis was performed using mixed effect model with treatment as a fixed effect and participant as a random effect.||229.60|135.51|
72617719|NCT05788328|144766490|OTHER||Ratio of Adjusted Geometric Means|221.62|||||TWO_SIDED|90.0|170.26|288.48|||||Ratio was of test to reference of adjusted geometric means. The reference arm was rosuvastatin 10 mg (Period 2) and test arm was PF-07081532 240 mg QD+rosuvastatin 10 mg (Period 8). The ratios (and 90% CIs) were expressed as percentages.|Analysis was performed using mixed effect model with treatment as a fixed effect and participant as a random effect.||288.48|170.26|
72617720|NCT00669331|144766554|SUPERIORITY_OR_OTHER||Rate Ratio Mannitol:Control|0.92||||0.3115|TWO_SIDED|95.0|0.78|1.08|||Negative binomial regression model|Negative binomial regression model with treatment, region and baseline PE rate as predictors and log of follow-up time as an offset variable|For rate ratio, Mannitol rate is the numerator, Control rate is the denominator|||1.08|0.78|0.3115
72617721|NCT00669331|144766555|SUPERIORITY_OR_OTHER||LS mean difference across the 52 weeks|-2.4||||0.0457|TWO_SIDED|95.0|-4.76|-0.05|||Mixed model repeated measures analysis|Model included treatment, visit, treatment\*visit, region and baseline SGRQ Total score.|difference calculated Mannitol-control. Negative difference is in favour of mannitol since lower scores indicate improved quality of life.|||-0.05|-4.76|0.0457
72617722|NCT00669331|144766556|SUPERIORITY_OR_OTHER||Rate ratio|0.91||||0.2754|TWO_SIDED|95.0|0.77|1.08|||Negative binomial regression model|Negative binomial regression model with treatment, region and baseline pulmonary exacerbation rate as predictors, log follow-up as offset|Rate ratio is for mannitol vs control.|||1.08|0.77|0.2754
72617723|NCT00669331|144766557|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.78||||0.0218|TWO_SIDED|95.0|0.63|0.96|||Regression, Cox|Cox regression model was stratified by region and baseline PE rate||||0.96|0.63|0.0218
72617724|NCT00669331|144766558|SUPERIORITY_OR_OTHER||Rate ratio|0.88||||0.3602|TWO_SIDED|95.0|0.67|1.16|||Negative binomial model|treatment, region and baseline pulmonary exacerbation rate as predictors, and with log of follow-up time as the offset variable||Analysed using a negative binomial model with treatment, region and baseline pulmonary exacerbation rate as predictors, and with log of follow-up time as the offset variable||1.16|0.67|0.3602
72617725|NCT00669331|144766559|SUPERIORITY_OR_OTHER||ls mean difference across 52 weeks|2.76||||0.0355|TWO_SIDED|95.0|0.19|5.33|||Mixed Models Analysis|Model includes treatment, visit, treatment\*visit, region and baseline sputum weight (g).|Difference mannitol-control|||5.33|0.19|0.0355
72617726|NCT00669331|144766560|SUPERIORITY_OR_OTHER||LS mean diff across post-baseline visits|-0.44||||0.1159|TWO_SIDED|95.0|-0.99|0.11|||Mixed Models Analysis|Model includes treatment, visit, treatment\*visit, region and baseline ESS score|Negative change indicates an improvement in ESS score. Difference calculated Mannitol - Control.|||0.11|-0.99|0.1159
72617727|NCT00669331|144766561|SUPERIORITY_OR_OTHER||Mean Difference (Net)|7.56||||0.6677|TWO_SIDED|95.0|-27.01|42.13|||Mixed Models Analysis|Model of absolute change from baseline in FEV1. Model includes terms for treatment, visit, trt\*visit, region and baseline value|ls mean difference Mannitol-Control|||42.13|-27.01|0.6677
72617728|NCT00669331|144766568|SUPERIORITY_OR_OTHER||Rate ratio|0.61||||0.0928|TWO_SIDED|95.0|0.34|1.09|||Negative binomial regression|||||1.09|0.34|0.0928
72617729|NCT00676052|144766594|SUPERIORITY||Mean Difference (Net)|0.067||||0.009|TWO_SIDED|95.0|0.017|0.117||Analysis performed using ANCOVA with covariates of Baseline, sex, age, smoking status, responsiveness stratum and treatment. Missing trough FEV1 data at Day 29 was imputed using LOCF.|ANCOVA|||||0.117|0.017|0.009
72617730|NCT00676052|144766594|SUPERIORITY||Mean Difference (Net)|0.097|||<|0.001|TWO_SIDED|95.0|0.047|0.147||Analysis performed using ANCOVA with covariates of Baseline, sex, age, smoking status, responsiveness stratum and treatment. Missing trough FEV1 data at Day 29 was imputed using LOCF.|ANCOVA|||||0.147|0.047|<0.001
72617731|NCT00676052|144766594|SUPERIORITY||Mean Difference (Net)|0.069||||0.007|TWO_SIDED|95.0|0.019|0.118||Analysis performed using ANCOVA with covariates of Baseline, sex, age, smoking status, responsiveness stratum and treatment. Missing trough FEV1 data at Day 29 was imputed using LOCF.|ANCOVA|||||0.118|0.019|0.007
72617732|NCT00676052|144766594|SUPERIORITY||Mean Difference (Net)|0.082||||0.001|TWO_SIDED|95.0|0.032|0.132||Analysis performed using ANCOVA with covariates of Baseline, sex, age, smoking status, responsiveness stratum and treatment. Missing trough FEV1 data at Day 29 was imputed using LOCF.|ANCOVA|||||0.132|0.032|0.001
72617733|NCT00676052|144766594|SUPERIORITY||Mean Difference (Net)|0.137|||<|0.001|TWO_SIDED|95.0|0.086|0.187||Analysis performed using ANCOVA with covariates of Baseline, sex, age, smoking status, responsiveness stratum and treatment. Missing trough FEV1 data at Day 29 was imputed using LOCF.|ANCOVA|||||0.187|0.086|<0.001
72617734|NCT00676052|144766595|SUPERIORITY||Mean Difference (Net)|0.106|||<|0.001|TWO_SIDED|95.0|0.065|0.146||Analysis performed using repeated measures with covariates of Baseline, sex, age, smoking status, responsiveness stratum, Day (nominal), treatment and Day by treatment and Day by Baseline interactions|Repeated Measures Model|||FEV1, Day 1||0.146|0.065|<0.001
72617735|NCT00676052|144766595|SUPERIORITY||Mean Difference (Net)|0.107|||<|0.001|TWO_SIDED|95.0|0.067|0.147||Analysis performed using repeated measures with covariates of Baseline, sex, age, smoking status, responsiveness stratum, Day (nominal), treatment and Day by treatment and Day by Baseline interactions|Repeated Measures Model|||FEV1, Day 1||0.147|0.067|<0.001
72617736|NCT00676052|144766595|SUPERIORITY||Mean Difference (Net)|0.123|||<|0.001|TWO_SIDED|95.0|0.083|0.163||Analysis performed using repeated measures with covariates of Baseline, sex, age, smoking status, responsiveness stratum, Day (nominal), treatment and Day by treatment and Day by Baseline interactions.|Repeated Measures Model|||FEV1, Day 1||0.163|0.083|<0.001
72617737|NCT00676052|144766595|SUPERIORITY||Mean Difference (Net)|0.152|||<|0.001|TWO_SIDED|95.0|0.112|0.193||Analysis performed using repeated measures with covariates of Baseline, sex, age, smoking status, responsiveness stratum, Day (nominal), treatment and Day by treatment and Day by Baseline interactions|Repeated Measures Model|||FEV1, Day 1||0.193|0.112|<0.001
72617738|NCT00676052|144766595|SUPERIORITY||Mean Difference (Net)|0.176|||<|0.001|TWO_SIDED|95.0|0.135|0.216||Analysis performed using repeated measures with covariates of Baseline, sex, age, smoking status, responsiveness stratum, Day (nominal), treatment and Day by treatment and Day by Baseline interactions.|Repeated Measures Model|||FEV1, Day 1||0.216|0.135|<0.001
72617739|NCT00676052|144766595|SUPERIORITY||Mean Difference (Net)|0.106|||<|0.001|TWO_SIDED|95.0|0.056|0.157||Analysis performed using repeated measures with covariates of Baseline, sex, age, smoking status, responsiveness stratum, Day (nominal), treatment and Day by treatment and Day by Baseline interactions|Repeated Measures Model|||FEV1, Day 28||0.157|0.056|<0.001
72617740|NCT00676052|144766595|SUPERIORITY||Mean Difference (Net)|0.142|||<|0.001|TWO_SIDED|95.0|0.092|0.192||Analysis performed using repeated measures with covariates of Baseline, sex, age, smoking status, responsiveness stratum, Day (nominal), treatment and Day by treatment and Day by Baseline interactions.|Repeated Measures Model|||FEV, Day 28||0.192|0.092|<0.001
72617741|NCT00676052|144766595|SUPERIORITY||Mean Difference (Net)|0.124|||<|0.001|TWO_SIDED|95.0|0.074|0.174||Analysis performed using repeated measures with covariates of Baseline, sex, age, smoking status, responsiveness stratum, Day (nominal), treatment and Day by treatment and Day by Baseline interactions|Repeated Measures Model|||FEV1, Day 28||0.174|0.074|<0.001
72617742|NCT00676052|144766595|SUPERIORITY||Mean Difference (Net)|0.142|||<|0.001|TWO_SIDED|95.0|0.092|0.193||Analysis performed using repeated measures with covariates of Baseline, sex, age, smoking status, responsiveness stratum, Day (nominal), treatment and Day by treatment and Day by Baseline interactions.|Repeated Measures Model|||FEV1, Day 28||0.193|0.092|<0.001
72617743|NCT00676052|144766595|SUPERIORITY||Mean Difference (Net)|0.17|||<|0.001|TWO_SIDED|95.0|0.12|0.22||Analysis performed using repeated measures with covariates of Baseline, sex, age, smoking status, responsiveness stratum, Day (nominal), treatment and Day by treatment and Day by Baseline interactions.|Repeated Measures Model|||FEV1, Day 28||0.220|0.120|<0.001
72617744|NCT00676052|144766596|SUPERIORITY||Mean Difference (Net)|0.166|||<|0.001|TWO_SIDED|95.0|0.094|0.237||Analysis performed using repeated measures with covariates of Baseline, sex, age, smoking status, responsiveness stratum, Day (nominal), treatment and Day by treatment and Day by Baseline interactions.|Repeated Measures Model|||Day 1||0.237|0.094|<0.001
72617745|NCT00676052|144766596|SUPERIORITY||Mean Difference (Net)|0.186|||<|0.001|TWO_SIDED|95.0|0.115|0.258||Analysis performed using repeated measures with covariates of Baseline, sex, age, smoking status, responsiveness stratum, Day (nominal), treatment and Day by treatment and Day by Baseline interactions.|Repeated Measures Model|||Day 1||0.258|0.115|<0.001
72617746|NCT00676052|144766596|SUPERIORITY||Mean Difference (Net)|0.198|||<|0.001|TWO_SIDED|95.0|0.127|0.268||Analysis performed using repeated measures with covariates of Baseline, sex, age, smoking status, responsiveness stratum, Day (nominal), treatment and Day by treatment and Day by Baseline interactions.|Repeated Measures Model|||Day 1||0.268|0.127|<0.001
72617747|NCT00676052|144766596|SUPERIORITY||Mean Difference (Net)|0.244|||<|0.001|TWO_SIDED|95.0|0.172|0.315||Analysis performed using repeated measures with covariates of Baseline, sex, age, smoking status, responsiveness stratum, Day (nominal), treatment and Day by treatment and Day by Baseline interactions.|Repeated Measures Model|||Day 1||0.315|0.172|<0.001
72617748|NCT00676052|144766596|SUPERIORITY||Mean Difference (Net)|0.301|||<|0.001|TWO_SIDED|95.0|0.229|0.372||Analysis performed using repeated measures with covariates of Baseline, sex, age, smoking status, responsiveness stratum, Day (nominal), treatment and Day by treatment and Day by Baseline interactions.|Repeated Measures Model|||Day 1||0.372|0.229|<0.001
72617749|NCT00676052|144766596|SUPERIORITY||Mean Difference (Net)|0.178|||<|0.001|TWO_SIDED|95.0|0.098|0.258||Analysis performed using repeated measures with covariates of Baseline, sex, age, smoking status, responsiveness stratum, Day (nominal), treatment and Day by treatment and Day by Baseline interactions.|Repeated Measures Model|||Day 28||0.258|0.098|<0.001
72617750|NCT00676052|144766596|SUPERIORITY||Mean Difference (Net)|0.219|||<|0.001|TWO_SIDED|95.0|0.139|0.298||Analysis performed using repeated measures with covariates of Baseline, sex, age, smoking status, responsiveness stratum, Day (nominal), treatment and Day by treatment and Day by Baseline interactions.|Repeated Measures Model|||Day 28||0.298|0.139|<0.001
72617751|NCT00676052|144766596|SUPERIORITY||Mean Difference (Net)|0.191|||<|0.001|TWO_SIDED|95.0|0.111|0.27||Analysis performed using repeated measures with covariates of Baseline, sex, age, smoking status, responsiveness stratum, Day (nominal), treatment and Day by treatment and Day by Baseline interactions.|Repeated Measures Model|||Day 28||0.270|0.111|<0.001
72617752|NCT00676052|144766596|SUPERIORITY||Mean Difference (Net)|0.232|||<|0.001|TWO_SIDED|95.0|0.152|0.312||Analysis performed using repeated measures with covariates of Baseline, sex, age, smoking status, responsiveness stratum, Day (nominal), treatment and Day by treatment and Day by Baseline interactions.|Repeated Measures Model|||Day 28||0.312|0.152|<0.001
72617753|NCT00676052|144766596|SUPERIORITY||Mean Difference (Net)|0.294|||<|0.001|TWO_SIDED|95.0|0.214|0.373||Analysis performed using repeated measures with covariates of Baseline, sex, age, smoking status, responsiveness stratum, Day (nominal), treatment and Day by treatment and Day by Baseline interactions.|Repeated Measures Model|||Day 28||0.373|0.214|<0.001
72617754|NCT00676052|144766597|SUPERIORITY||Mean Difference (Net)|0.099||||0.021|TWO_SIDED|95.0|0.015|0.182||Analysis performed using repeated measures with covariates of Baseline, sex, age, smoking status, responsiveness stratum, Day (nominal), treatment and Day by treatment and Day by Baseline interactions.|Repeated Measures Model|||||0.182|0.015|0.021
72617755|NCT00676052|144766597|SUPERIORITY||Mean Difference (Net)|0.15|||<|0.001|TWO_SIDED|95.0|0.067|0.233||Analysis performed using repeated measures with covariates of Baseline, sex, age, smoking status, responsiveness stratum, Day (nominal), treatment and Day by treatment and Day by Baseline interactions.|Repeated Measures Model|||||0.233|0.067|<0.001
72617756|NCT00676052|144766597|SUPERIORITY||Mean Difference (Net)|0.094||||0.026|TWO_SIDED|95.0|0.011|0.177||Analysis performed using repeated measures with covariates of Baseline, sex, age, smoking status, responsiveness stratum, Day (nominal), treatment and Day by treatment and Day by Baseline interactions.|Repeated Measures Model|||||0.177|0.011|0.026
72617757|NCT00676052|144766597|SUPERIORITY||Mean Difference (Net)|0.163|||<|0.001|TWO_SIDED|95.0|0.08|0.247||Analysis performed using repeated measures with covariates of Baseline, sex, age, smoking status, responsiveness stratum, Day (nominal), treatment and Day by treatment and Day by Baseline interactions.|Repeated Measures Model|||||0.247|0.080|<0.001
72617758|NCT00676052|144766597|SUPERIORITY||Mean Difference (Net)|0.235|||<|0.001|TWO_SIDED|95.0|0.152|0.319||Analysis performed using repeated measures with covariates of Baseline, sex, age, smoking status, responsiveness stratum, Day (nominal), treatment and Day by treatment and Day by Baseline interactions.|Repeated Measures Model|||||0.319|0.152|<0.001
72617759|NCT03300336|144766598|SUPERIORITY||Odds Ratio (OR)|0.77||||0.01|TWO_SIDED|95.0|0.64|0.93||a priori threshold for statistical significance p \<.05|generalized linear model|generalized linear model with a logit link and a binomial distribution|Odds in intervention numerator vs odds in usual care denominator|Model included a time-varying indicator for when STRIDE program launched, fixed effects for time (indicator variables for each of the 7 post-baseline timepoints), and a site-level random effect. Model was not adjusted for patient characteristics. Estimated means and standard errors are provided in Outcome Measure Data table.||0.93|0.64|0.01
72617760|NCT03300336|144766599|SUPERIORITY||rate ratio|1.05||||0.25|TWO_SIDED|95.0|0.97|1.15||a priori threshold for statistical significance p\<.05|generalized linear model|generalized linear model with a log link and negative binomial distribution.|The rate ratio compares the intervention rate in the numerator vs the usual care rate in the denominator|Model included a time-varying indicator for when STRIDE program launched, fixed effects for time (indicator variables for each of the 7 post-baseline time points), a site-level random effect and random effects for each of the time periods. Model was not adjusted for patient characteristics. Estimated means and standard errors are provided in Outcome Measure Data table.||1.15|0.97|0.25
72617761|NCT03300336|144766600|SUPERIORITY||Mean Difference (Net)|1.32||||0.52|TWO_SIDED|95.0|-2.7|5.33||a priori threshold for statistical significance p\<.05|Mixed Models Analysis||Estimated difference calculated as intervention minus control|"Model included a time-varying indicator for when STRIDE program launched, fixed effects for time (indicator variables for each of the time periods) and a site-level random effect. Model was not adjusted for patient characteristics.~Missing data due to item nonresponse in usual care group: 5 out of 227 Missing data due to item nonresponse in intervention group: 18 out of 399~Estimated means and standard errors are provided in Outcome Measure Data table."||5.33|-2.70|0.52
72617762|NCT03300336|144766601|SUPERIORITY||Mean Difference (Net)|1.56||||0.66|TWO_SIDED|95.0|-3.14|6.25||a priori threshold for statistical significance p\<.05|Mixed Models Analysis||Estimated difference calculated as intervention minus control|"Model included a time-varying indicator for when STRIDE program launched, fixed effects for time (indicator variables for each of the time periods) and a site-level random effect. Model was not adjusted for patient characteristics.~Missing data due to item nonresponse in usual care group: 5 out of 227 Missing data due to item nonresponse in intervention group: 18 out of 399~Estimated means and standard errors are provided in Outcome Measure Data table."||6.25|-3.14|0.66
72622308|NCT04250207|144774537|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.|||||<|0.0001|||||||Chi-square or Fisher exact|||Week 16||||< 0.0001
72617763|NCT03300336|144766602|SUPERIORITY||Mean Difference (Net)|-0.52||||0.81|TWO_SIDED|95.0|-4.74|3.7||a priori threshold for significance p\<.05|Mixed Models Analysis||Estimated difference calculated as intervention minus control|"Model included a time-varying indicator for when STRIDE program launched, fixed effects for time (indicator variables for each of the time periods) and a site-level random effect.. Model was not adjusted for patient characteristics.~Missing data due to item nonresponse in usual care group: 5 out of 227 Missing data due to item nonresponse in intervention group: 14 out of 399~Estimated means and standard errors are provided in Outcome Measure Data table."||3.70|-4.74|0.81
72617764|NCT03300336|144766603|SUPERIORITY||Odds Ratio (OR)|1.13||||0.74|TWO_SIDED|95.0|0.55|2.32||a priori threshold for statistical significance p\<.05|generalized linear model|generalized linear model with a logit link and a binomial distribution|Odds in intervention numerator vs odds in usual care denominator|"Model included a time-varying indicator for when STRIDE program launched, fixed effects for time (indicator variables for each of the time periods) and a site-level random effect. Model was not adjusted for patient characteristics.~Missing data due to item nonresponse in usual care: 0 out of 227 Missing data due to item nonresponse in intervention: 5 out of 399~Estimated means and standard errors are provided in Outcome Measure Data table."||2.32|0.55|0.74
72617765|NCT03300336|144766604|SUPERIORITY||Mean Difference (Net)|0.02||||0.4|TWO_SIDED|95.0|-0.03|0.06||a priori threshold for statistical significance p\<.05|Mixed Models Analysis||Estimated difference calculated as intervention minus control|"Model included a time-varying indicator for when STRIDE program launched, fixed effects for time (indicator variables for each of the time periods) and a site-level random effect. Model was not adjusted for patient characteristics.~Missing data due to item nonresponse in usual care: 14 out of 227 Missing data due to item nonresponse in intervention: 33 out of 399~Estimated means and standard errors are provided in Outcome Measure Data table."||0.06|-0.03|0.40
72617766|NCT03300336|144766605|SUPERIORITY||Mean Difference (Net)|0.03||||0.18|TWO_SIDED|95.0|-0.01|0.07||a priori threshold for statistical significance p\<.05|Mixed Models Analysis||Estimated difference calculated as intervention minus control|"Model included a time-varying indicator for when STRIDE program launched, fixed effects for time (indicator variables for each of the time periods) and a site-level random effect. Model was not adjusted for patient characteristics.~Missing data due to item nonresponse in usual care: 7 out of 227 Missing data due to item nonresponse in intervention: 23 out of 399~Estimated means and standard errors are provided in Outcome Measure Data table."||0.07|-0.01|0.18
72617767|NCT03300336|144766606|SUPERIORITY||Mean Difference (Net)|0.8||||0.83|TWO_SIDED|95.0|-6.38|7.98||a priori threshold for statistical significance p\<.05|Mixed Models Analysis||Estimated difference calculated as intervention minus control|"Model included a time-varying indicator for when STRIDE program launched, fixed effects for time (indicator variables for each of the time periods) and a site-level random effect. Model was not adjusted for patient characteristics.~Missing data due to item nonresponse in usual care: 1 out of 227 Missing data due to item nonresponse in intervention: 4 out of 399~Estimated means and standard errors are provided in Outcome Measure Data table."||7.98|-6.38|0.83
72617768|NCT03300336|144766607|SUPERIORITY||Mean Difference (Net)|1.46||||0.25|TWO_SIDED|95.0|-1.05|3.96||a priori threshold for statistical significance p\<.05|Mixed Models Analysis||Estimated difference calculated as intervention minus control|"Model included a time-varying indicator for when STRIDE program launched, fixed effects for time (indicator variables for each of the time periods) and a site-level random effect. Model was not adjusted for patient characteristics.~Missing data due to item nonresponse in usual care: 2 out of 227 Missing data due to item nonresponse in intervention: 6 out of 399~Estimated means and standard errors are provided in Outcome Measure Data table."||3.96|-1.05|0.25
72617769|NCT03300336|144766608|SUPERIORITY||Odds Ratio (OR)|1.16||||0.59|TWO_SIDED|95.0|0.68|1.99||a priori threshold for statistical significance p\<.05|generalized linear model|generalized linear model with a logit link and a binomial distribution|Odds in intervention numerator vs odds in usual care denominator|"Model included a time-varying indicator for when STRIDE program launched, fixed effects for time (indicator variables for each of the time periods) and a site-level random effect. Model was not adjusted for patient characteristics.~Missing data due to item nonresponse in usual care: 1 out of 227 Missing data due to item nonresponse in intervention: 3 out of 399~Estimated means and standard errors are provided in Outcome Measure Data table."||1.99|0.68|0.59
72617770|NCT03300336|144766609|SUPERIORITY||Mean Difference (Net)|0.99||||0.47|TWO_SIDED|95.0|-1.71|3.69||a priori threshold for statistical significance p\<.05|Mixed Models Analysis||Estimated difference calculated as intervention minus control|"Model included a time-varying indicator for when STRIDE program launched, fixed effects for time (indicator variables for each of the time periods) and a site-level random effect. Model was not adjusted for patient characteristics.~Missing data due to item nonresponse in usual care: 11 out of 227 Missing data due to item nonresponse in intervention: 20 out of 399~Estimated means and standard errors are provided in Outcome Measure Data table."||3.69|-1.71|0.47
72617771|NCT03300336|144766610|SUPERIORITY||Mean Difference (Net)|-0.07||||0.94|TWO_SIDED|95.0|-1.76|1.62||a priori threshold for statistical significance p\<.05|Mixed Models Analysis||Estimated difference calculated as intervention minus control|"Model included a time-varying indicator for when STRIDE program launched, fixed effects for time (indicator variables for each of the time periods) and a site-level random effect. Model was not adjusted for patient characteristics.~Missing data due to item nonresponse in usual care: 2 out of 227 Missing data due to item nonresponse in intervention group: 7 out of 399~Estimated means and standard errors are provided in Outcome Measure Data table."||1.62|-1.76|0.94
72617772|NCT01960842|144766612|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.64|||<|0.001|TWO_SIDED|95.0|-5.78|-3.5|||One-sample t-test, 2-sided|||||-3.50|-5.78|<0.001
72617773|NCT01960842|144766613|SUPERIORITY_OR_OTHER||Mean Difference (Net)|5.58|||<|0.001|TWO_SIDED|95.0|4.21|6.95|||One-sample t-test, 2-sided|||||6.95|4.21|<0.001
72617774|NCT01960842|144766614|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-12.0|||<|0.001|TWO_SIDED|95.0|-16.3|-7.7|||One-sample t-test, 2-sided|||||-7.7|-16.3|<0.001
72371627|NCT00669409|144253451|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-11.5|STANDARD_ERROR_OF_MEAN|10.75|||TWO_SIDED|95.0|-32.8|9.7||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||9.7|-32.8|
72371628|NCT00669409|144253452|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-6.4|STANDARD_ERROR_OF_MEAN|8.33|||TWO_SIDED|95.0|-22.9|10.1||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||10.1|-22.9|
72371629|NCT00669409|144253452|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-19.4|STANDARD_ERROR_OF_MEAN|8.25|||TWO_SIDED|95.0|-35.7|-3.1||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-3.1|-35.7|
72555097|NCT03086460|144641774|SUPERIORITY||Mean Difference (Final Values)|0.047||||0.2|TWO_SIDED|95.0|-0.025|0.119|||ANCOVA|||"Day 1~Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment B (CHF 1531 pMDI 12 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.119|-0.025|0.200
72371630|NCT00669409|144253452|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|1.3|STANDARD_ERROR_OF_MEAN|8.25|||TWO_SIDED|95.0|-15.0|17.6||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||17.6|-15.0|
72617775|NCT01960842|144766615|SUPERIORITY_OR_OTHER||Mean change from score = 4|-2.1|STANDARD_DEVIATION|0.77|<|0.001|TWO_SIDED||||||Wilcoxon signed-rank test|||The p-value is based on a one-sample Wilcoxon signed-rank test with the hypothesis of no change (score = 4).||||<0.001
72617776|NCT01960842|144766616|SUPERIORITY_OR_OTHER||Mean change from score = 4|-2.0|STANDARD_DEVIATION|0.94|<|0.001|TWO_SIDED||||||Wilcoxon signed-rank test|||The p-value is based on a one-sample Wilcoxon signed-rank test with the hypothesis of no change (score = 4).||||<0.001
72617777|NCT01960842|144766617|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.8|||=|0.101|TWO_SIDED|95.0|-4.0|0.4|||One-sample t-test, 2-sided|||||0.4|-4.0|=0.101
72617778|NCT01960842|144766618|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.1|||=|0.182|TWO_SIDED|95.0|-5.3|1.1|||One-sample t-test, 2-sided|||||1.1|-5.3|=0.182
72371631|NCT00669409|144253452|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-11.0|STANDARD_ERROR_OF_MEAN|8.14|||TWO_SIDED|95.0|-27.1|5.1||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||5.1|-27.1|
72371632|NCT00669409|144253452|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-4.8|STANDARD_ERROR_OF_MEAN|10.75|||TWO_SIDED|95.0|-26.0|16.5||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||16.5|-26.0|
72371633|NCT00669409|144253453|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-4.6|STANDARD_ERROR_OF_MEAN|8.33|||TWO_SIDED|95.0|-21.1|11.9||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||11.9|-21.1|
72371634|NCT00669409|144253453|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-19.6|STANDARD_ERROR_OF_MEAN|8.25|||TWO_SIDED|95.0|-35.9|-3.3||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-3.3|-35.9|
72371635|NCT00669409|144253453|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-4.1|STANDARD_ERROR_OF_MEAN|8.25|||TWO_SIDED|95.0|-20.4|12.2||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||12.2|-20.4|
72371636|NCT00669409|144253453|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-13.8|STANDARD_ERROR_OF_MEAN|8.14|||TWO_SIDED|95.0|-30.0|2.3||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||2.3|-30.0|
72371637|NCT00669409|144253453|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-27.5|STANDARD_ERROR_OF_MEAN|10.75|||TWO_SIDED|95.0|-48.8|-6.2||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-6.2|-48.8|
72371638|NCT00669409|144253454|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-3.1|STANDARD_ERROR_OF_MEAN|8.33|||TWO_SIDED|95.0|-19.6|13.4||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||13.4|-19.6|
72371639|NCT00669409|144253454|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-19.5|STANDARD_ERROR_OF_MEAN|8.25|||TWO_SIDED|95.0|-35.8|-3.1||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-3.1|-35.8|
72371640|NCT00669409|144253454|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-9.1|STANDARD_ERROR_OF_MEAN|8.25|||TWO_SIDED|95.0|-25.4|7.2||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||7.2|-25.4|
72555098|NCT03086460|144641774|SUPERIORITY||Mean Difference (Final Values)|0.076||||0.037|TWO_SIDED|95.0|0.005|0.146|||ANCOVA|||"Day 1~Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment C (CHF 1531 pMDI 24 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.146|0.005|0.037
72617779|NCT01960842|144766619|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.0|||=|0.032|TWO_SIDED|95.0|-1.9|-0.09|||One-sample t-test, 2-sided|||||-0.09|-1.90|=0.032
72617780|NCT01960842|144766620|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-19.2|||<|0.001|TWO_SIDED|95.0|-27.8|-10.6|||One-sample t-test, 2-sided|||Mobility Domain analysis.||-10.6|-27.8|<0.001
72617781|NCT01960842|144766620|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-6.5|||=|0.059|TWO_SIDED|95.0|-13.3|0.3|||One-sample t-test, 2-sided|||Emotional Well-Being Domain analysis.||0.3|-13.3|=0.059
72617782|NCT01960842|144766620|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-7.5|||=|0.07|TWO_SIDED|95.0|-15.6|0.6|||One-sample t-test, 2-sided|||Stigma Domain analysis.||0.6|-15.6|=0.070
72617783|NCT01960842|144766620|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.5|||=|0.591|TWO_SIDED|95.0|-7.3|4.2|||One-sample t-test, 2-sided|||Social Support Domain analysis.||4.2|-7.3|=0.591
72617784|NCT01960842|144766620|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-14.0|||<|0.001|TWO_SIDED|95.0|-20.7|-7.3|||One-sample t-test, 2-sided|||Cognition Domain analysis.||-7.3|-20.7|<0.001
72617785|NCT01960842|144766620|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.1|||=|0.67|TWO_SIDED|95.0|-4.2|6.4|||One-sample t-test, 2-sided|||Communication Domain analysis.||6.4|-4.2|=0.670
72617786|NCT01960842|144766620|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-17.8|||<|0.001|TWO_SIDED|95.0|-25.2|-10.3|||One-sample t-test, 2-sided|||Bodily Discomfort Domain analysis.||-10.3|-25.2|<0.001
72617787|NCT01960842|144766621|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.8|||=|0.056|TWO_SIDED|95.0|-9.8|0.1|||One-sample t-test, 2-sided|||||0.1|-9.8|=0.056
72617788|NCT01960842|144766622|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.9|||=|0.011|TWO_SIDED|95.0|-1.6|-0.2|||One-sample t-test, 2-sided|||||-0.2|-1.6|=0.011
72617789|NCT01960842|144766623|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.2|||<|0.001|TWO_SIDED|95.0|-4.4|-1.9|||One-sample t-test, 2-sided|||||-1.9|-4.4|<0.001
72617790|NCT01960842|144766624|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.65|||<|0.001|TWO_SIDED|95.0|-5.83|-3.47|||One-sample t-test, 2-sided|||||-3.47|-5.83|<0.001
72617791|NCT01960842|144766625|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.58|||<|0.001|TWO_SIDED|95.0|-5.73|-3.44|||One-sample t-test, 2-sided|||||-3.44|-5.73|<0.001
72617792|NCT01301001|144766634|SUPERIORITY||Mean Difference (Final Values)|-0.3||||0.07|TWO_SIDED|95.0|-0.7|0.0|||Mixed Models Analysis|||||0.0|-0.7|0.07
72617793|NCT01301001|144766635|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.76|TWO_SIDED|95.0|-0.9|0.6|||Mixed Models Analysis|||||0.6|-0.9|0.76
72617794|NCT01301001|144766636|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.36|TWO_SIDED|95.0|-0.5|0.2|||Mixed Models Analysis|||||0.2|-0.5|0.36
72617795|NCT00378560|144766637|SUPERIORITY_OR_OTHER||Percent Relative Risk Reduction|87.6|||||TWO_SIDED|95.0|59.2|97.6|||||Binomial probability conditional on the fixed number of events.|||97.6|59.2|
72617796|NCT00378560|144766638|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.001
72617797|NCT00378560|144766639|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.001
72617798|NCT00378560|144766640|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.001
72617799|NCT00378560|144766641|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.001
72617800|NCT00976391|144766642|NON_INFERIORITY_OR_EQUIVALENCE|P-value from a one-sided t-test to test whether the difference of least square means (albiglutide - preprandial lispro insulin) is less than or equal to the pre-specified non-inferiority margin of 0.4%|Mean Difference (Net)|-0.16|||<|0.0001|TWO_SIDED|95.0|-0.32|0.0|||t-test, 1 sided|||||0.00|-0.32|<0.0001
72617801|NCT03203512|144766655|SUPERIORITY||||||<|0.001||||||Treatment effect: p\<0.001; period effect : p=0.552; treatment x period interaction: p=0.622|ANOVA|||Null hypothesis is that there was no difference in change of total EV numbers detected by NTA between fish oil and placebo capsules. A general linear model with fixed factors of treatment and period was conducted to determine the differences in the effect of two treatments and two periods on total EV numbers.||||<0.001
72617802|NCT03203512|144766656|SUPERIORITY||||||=|0.001||||||Treatment: p=0.001; period: p=0.646; treatment x period interaction: p=0.267|ANOVA|||Null hypothesis is that there was no difference in change of total PS+EV numbers detected by FCM between fish oil and placebo capsules. A general linear model with fixed factors of treatment and period was conducted to determine the differences in the effect of two treatments and two periods on total PS+EV numbers.||||=0.001
72617803|NCT03203512|144766657|SUPERIORITY||||||=|0.002||||||Treatment: p=0.002; period: p=0.350; treatment x period interaction: p=0.572|ANOVA|||Null hypothesis is that there was no difference in change of PDEV numbers detected by FCM between fish oil and placebo capsules. A general linear model with fixed factors of treatment and period was conducted to determine the differences in the effect of two treatments and two periods on PDEV numbers.||||=0.002
72617804|NCT03203512|144766657|SUPERIORITY|Null hypothesis is that there was no difference in change of EDEV numbers detected by FCM between fish oil and placebo capsules. A general linear model with fixed factors of treatment and period was conducted to determine the differences in the effect of two treatments and two periods on EDEV numbers.|||||<|0.001||||||Treatment: p\<0.001; period: p=0.362; treatment x period interaction: p=0.225|ANOVA|||||||<0.001
72617805|NCT03203512|144766658|SUPERIORITY||||||<|0.001||||||Treatment: p\<0.001; period: p=0.010; treatment x period: p=0.608|ANOVA|||Null hypothesis is that there was no difference in change of EV thrombogenicity in affecting lag time for TF-dependent thrombin generation between fish oil and placebo capsules. A general linear model with fixed factors of treatment and period was conducted to determine the differences in the effect of two treatments and two periods on EV thrombogenicity.||||<0.001
72617806|NCT03203512|144766659|SUPERIORITY||||||<|0.001||||||Treatment: p\<0.001; period: p=0.073; treatment x period: p=0.667|ANOVA|||Null hypothesis is that there was no difference in change of EV thrombogenicity in affecting TF-dependent thrombin peak concentration between fish oil and placebo capsules. A general linear model with fixed factors of treatment and period was conducted to determine the differences in the effect of two treatments and two periods on EV thrombogenicity.||||<0.001
72617807|NCT03203512|144766660|SUPERIORITY||||||<|0.001||||||Treatment: p\<0.001; period: p=0.138; treatment x period: p=0.872|ANOVA|||Null hypothesis is that there was no difference in change of EV thrombogenicity in affecting the time to reach peak TF-dependent thrombin concentration between fish oil and placebo capsules. A general linear model with fixed factors of treatment and period was conducted to determine the differences in the effect of two treatments and two periods on EV thrombogenicity.||||<0.001
72617808|NCT03203512|144766661|SUPERIORITY||||||=|0.015||||||Treatment: p=0.015; period: p=0.059; treatment x period: p=0.220|ANOVA|||Null hypothesis is that there was no difference in change of EV thrombogenicity in affecting TF-dependent velocity index between fish oil and placebo capsules. A general linear model with fixed factors of treatment and period was conducted to determine the differences in the effect of two treatments and two periods on EV thrombogenicity.||||=0.015
72617809|NCT03203512|144766662|SUPERIORITY||||||<|0.001||||||Treatment: p\<0.001; period: p=0.118; treatment x period: p=0.802|ANOVA|||Null hypothesis is that there was no difference in change of EV thrombogenicity in affecting TF-dependent endogenous thrombin potential (ETP) between fish oil and placebo capsules. A general linear model with fixed factors of treatment and period was conducted to determine the differences in the effect of two treatments and two periods on EV thrombogenicity.||||<0.001
72617810|NCT03203512|144766663|SUPERIORITY||||||>|0.05|||||||ANOVA|||Null hypothesis is that there was no difference in change of platelet function in affecting LogEC50 values in response to ADP between fish oil and placebo capsules. Comparisons of this parameter after each intervention were drawn using 2-way ANOVA with the Turkey multiple comparisons test.||||>0.05
72371641|NCT00669409|144253454|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-16.6|STANDARD_ERROR_OF_MEAN|8.14|||TWO_SIDED|95.0|-32.8|-0.5||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-0.5|-32.8|
72371642|NCT00669409|144253454|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-32.6|STANDARD_ERROR_OF_MEAN|10.75|||TWO_SIDED|95.0|-53.9|-11.4||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-11.4|-53.9|
72371643|NCT00669409|144253455|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-3.6|STANDARD_ERROR_OF_MEAN|8.33|||TWO_SIDED|95.0|-20.1|12.9||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||12.9|-20.1|
72371644|NCT00669409|144253455|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-21.5|STANDARD_ERROR_OF_MEAN|8.25|||TWO_SIDED|95.0|-37.9|-5.2||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-5.2|-37.9|
72371645|NCT00669409|144253455|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-9.4|STANDARD_ERROR_OF_MEAN|8.25|||TWO_SIDED|95.0|-25.7|6.9||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||6.9|-25.7|
72371646|NCT00669409|144253455|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-15.4|STANDARD_ERROR_OF_MEAN|8.14|||TWO_SIDED|95.0|-31.5|0.7||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||0.7|-31.5|
72371647|NCT00669409|144253455|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-32.5|STANDARD_ERROR_OF_MEAN|10.75|||TWO_SIDED|95.0|-53.7|-11.2||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-11.2|-53.7|
72371648|NCT00669409|144253456|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|8.33|||TWO_SIDED|95.0|-17.0|16.0||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||16.0|-17.0|
72371649|NCT00669409|144253456|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-21.3|STANDARD_ERROR_OF_MEAN|8.25|||TWO_SIDED|95.0|-37.6|-4.9||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-4.9|-37.6|
72371650|NCT00669409|144253456|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-7.8|STANDARD_ERROR_OF_MEAN|8.25|||TWO_SIDED|95.0|-24.1|8.5||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||8.5|-24.1|
72371651|NCT00669409|144253456|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-16.1|STANDARD_ERROR_OF_MEAN|8.14|||TWO_SIDED|95.0|-32.2|0.0||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||0.0|-32.2|
72617811|NCT03203512|144766663|SUPERIORITY||||||>|0.05|||||||ANOVA|||Null hypothesis is that there was no difference in change of platelet function in affecting LogEC50 values in response to epinephrine between fish oil and placebo capsules. Comparisons of this parameter after each intervention were drawn using 2-way ANOVA with the Turkey multiple comparisons test.||||>0.05
72371652|NCT00669409|144253456|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-26.8|STANDARD_ERROR_OF_MEAN|10.75|||TWO_SIDED|95.0|-48.1|-5.5||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-5.5|-48.1|
72371653|NCT00669409|144253457|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|3.7|STANDARD_ERROR_OF_MEAN|8.33|||TWO_SIDED|95.0|-12.8|20.2||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||20.2|-12.8|
72371654|NCT00669409|144253457|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-18.5|STANDARD_ERROR_OF_MEAN|8.25|||TWO_SIDED|95.0|-34.8|-2.2||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-2.2|-34.8|
72371655|NCT00669409|144253457|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-5.3|STANDARD_ERROR_OF_MEAN|8.25|||TWO_SIDED|95.0|-21.7|11.0||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||11.0|-21.7|
72371656|NCT00669409|144253457|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-14.0|STANDARD_ERROR_OF_MEAN|8.14|||TWO_SIDED|95.0|-30.1|2.1||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||2.1|-30.1|
72371657|NCT00669409|144253457|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-24.8|STANDARD_ERROR_OF_MEAN|10.75|||TWO_SIDED|95.0|-46.0|-3.5||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-3.5|-46.0|
72371658|NCT00669409|144253458|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|9.0|STANDARD_ERROR_OF_MEAN|8.33|||TWO_SIDED|95.0|-7.5|25.5||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||25.5|-7.5|
72371659|NCT00669409|144253458|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-15.7|STANDARD_ERROR_OF_MEAN|8.25|||TWO_SIDED|95.0|-32.0|0.6||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||0.6|-32.0|
72371660|NCT00669409|144253458|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|8.25|||TWO_SIDED|95.0|-16.7|15.9||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||15.9|-16.7|
72371661|NCT00669409|144253458|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-9.4|STANDARD_ERROR_OF_MEAN|8.14|||TWO_SIDED|95.0|-25.5|6.7||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||6.7|-25.5|
72371662|NCT00669409|144253458|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-20.8|STANDARD_ERROR_OF_MEAN|10.75|||TWO_SIDED|95.0|-42.0|0.5||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||0.5|-42.0|
72371663|NCT00669409|144253459|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|8.1|STANDARD_ERROR_OF_MEAN|8.33|||TWO_SIDED|95.0|-8.4|24.6||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||24.6|-8.4|
72617812|NCT03203512|144766663|SUPERIORITY||||||>|0.05|||||||ANOVA|||Null hypothesis is that there was no difference in change of platelet function in affecting LogEC50 values in response to TRAP-6 between fish oil and placebo capsules. Comparisons of this parameter after each intervention were drawn using 2-way ANOVA with the Turkey multiple comparisons test.||||>0.05
72617813|NCT03203512|144766663|SUPERIORITY||||||>|0.05|||||||ANOVA|||Null hypothesis is that there was no difference in change of platelet function in affecting LogEC50 values in response to U46619 between fish oil and placebo capsules. Comparisons of this parameter after each intervention were drawn using 2-way ANOVA with the Turkey multiple comparisons test.||||>0.05
72617814|NCT03203512|144766664|SUPERIORITY||||||>|0.05|||||||ANOVA|||Null hypothesis is that there was no difference in change of platelet function in affecting LogEC50 values in response to CRP-XL between fish oil and placebo capsules. Comparisons of this parameter after each intervention were drawn using 2-way ANOVA with the Turkey multiple comparisons test.||||>0.05
72617815|NCT03203512|144766665|SUPERIORITY||||||>|0.05|||||||ANOVA|||Null hypothesis is that there was no difference in change of pro-thrombotic activity of PDEVs in affecting endpoint for ex vivo thrombus formation between fish oil and placebo capsules. A general linear model with fixed factors of treatment and period was conducted to determine the differences in the effect of two treatments and two periods on the pro-thrombotic activity of PDEVs.||||>0.05
72617816|NCT03203512|144766665|SUPERIORITY||||||>|0.05|||||||ANOVA|||Null hypothesis is that there was no difference in change of pro-thrombotic activity of PDEVs in affectingamximum for ex vivo thrombus formation between fish oil and placebo capsules. A general linear model with fixed factors of treatment and period was conducted to determine the differences in the effect of two treatments and two periods on the pro-thrombotic activity of PDEVs.||||>0.05
72617817|NCT03203512|144766666|SUPERIORITY||||||>|0.05|||||||ANOVA|||Null hypothesis is that there was no difference in change of pro-thrombotic activity of PDEVs in affecting area under curve for ex vivo thrombus formation between fish oil and placebo capsules. A general linear model with fixed factors of treatment and period was conducted to determine the differences in the effect of two treatments and two periods on the pro-thrombotic activity of PDEVs.||||>0.05
72617818|NCT03203512|144766667|SUPERIORITY||||||<|0.001||||||Treatment: \<0.001; period: p=0.978; treatment x period interaction: p=0.140|ANOVA|||Null hypothesis is that there was no difference in change of EPA in circulating EV total lipids between fish oil and placebo capsules. A general linear model with fixed factors of treatment and period was conducted to determine the differences in the effect of two treatments and two periods on EPA in circulating EV total lipids.||||<0.001
72617819|NCT03203512|144766667|SUPERIORITY||||||<|0.001||||||Treatment: p\<0.001; period: p=0.699; treatment x period interaction: p=0.114|ANOVA|||Null hypothesis is that there was no difference in change of DHA in circulating EV total lipids between fish oil and placebo capsules. A general linear model with fixed factors of treatment and period was conducted to determine the differences in the effect of two treatments and two periods on DHA in circulating EV total lipids.||||<0.001
72617820|NCT03203512|144766667|SUPERIORITY||||||=|0.011||||||Treatment: p=0.011; period: p=0.381; treatment x period interaction: p=0.762|ANOVA|||Null hypothesis is that there was no difference in change of oleic acid in circulating EV total lipids between fish oil and placebo capsules. A general linear model with fixed factors of treatment and period was conducted to determine the differences in the effect of two treatments and two periods on oleic acid in circulating EV total lipids.||||=0.011
72617821|NCT03203512|144766667|SUPERIORITY||||||<|0.001||||||Treatment: p\<0.001; period: p=0.512; treatment x period interaction: p=0.812|ANOVA|||Null hypothesis is that there was no difference in change of AA in circulating EV total lipids between fish oil and placebo capsules. A general linear model with fixed factors of treatment and period was conducted to determine the differences in the effect of two treatments and two periods on AA in circulating EV total lipids.||||<0.001
72617822|NCT03203512|144766667|SUPERIORITY||||||<|0.001||||||Treatment: p\<0.001; period: p=0.160; treatment x period interaction: p=0.132|ANOVA|||Null hypothesis is that there was no difference in change of total n-3 PUFA in circulating EV total lipids between fish oil and placebo capsules. A general linear model with fixed factors of treatment and period was conducted to determine the differences in the effect of two treatments and two periods on total n-3 PUFA in circulating EV total lipids.||||<0.001
72617823|NCT03203512|144766667|SUPERIORITY||||||=|0.013||||||Treatment: p=0.013; period: p=0.500; treatment x period interaction: p=0.522|ANOVA|||Null hypothesis is that there was no difference in change of total MUFA in circulating EV total lipids between fish oil and placebo capsules. A general linear model with fixed factors of treatment and period was conducted to determine the differences in the effect of two treatments and two periods on total MUFA in circulating EV total lipids.||||=0.013
72617824|NCT03203512|144766668|SUPERIORITY||||||<|0.001||||||Treatment: p\<0.001; period: p=0.169; treatment x period interaction: p=0.629|ANOVA|||Null hypothesis is that there was no difference in change of EPA in plasma total phospholipids between fish oil and placebo capsules. A general linear model with fixed factors of treatment and period was conducted to determine the differences in the effect of two treatments and two periods on EPA in plasma total phospholipids.||||<0.001
72617825|NCT03203512|144766668|SUPERIORITY||||||<|0.001||||||Treatment: p\<0.001; period: p=0.262; treatment x period interaction: p=0.150|ANOVA|||Null hypothesis is that there was no difference in change of DHA in plasma total phospholipids between fish oil and placebo capsules. A general linear model with fixed factors of treatment and period was conducted to determine the differences in the effect of two treatments and two periods on DHA in plasma total phospholipids.||||<0.001
72622309|NCT04250207|144774537|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.||||||0.0011|||||||Chi-square or Fisher exact|||Week 16||||0.0011
72622310|NCT04250207|144774537|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.||||||0.0094|||||||Chi-square or Fisher exact|||Week 20||||0.0094
72622311|NCT04250207|144774537|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.||||||0.1281|||||||Chi-square or Fisher exact|||Week 20||||0.1281
72371664|NCT00669409|144253459|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-16.3|STANDARD_ERROR_OF_MEAN|8.25|||TWO_SIDED|95.0|-32.6|0.0||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||0.0|-32.6|
72371665|NCT00669409|144253459|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|8.25|||TWO_SIDED|95.0|-17.1|15.5||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||15.5|-17.1|
72371666|NCT00669409|144253459|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-8.3|STANDARD_ERROR_OF_MEAN|8.14|||TWO_SIDED|95.0|-24.4|7.8||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||7.8|-24.4|
72371667|NCT00669409|144253459|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-16.7|STANDARD_ERROR_OF_MEAN|10.75|||TWO_SIDED|95.0|-38.0|4.5||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||4.5|-38.0|
72371668|NCT00669409|144253460|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|8.8|STANDARD_ERROR_OF_MEAN|8.33|||TWO_SIDED|95.0|-7.7|25.3||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||25.3|-7.7|
72371669|NCT00669409|144253460|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-12.9|STANDARD_ERROR_OF_MEAN|8.25|||TWO_SIDED|95.0|-29.2|3.5||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||3.5|-29.2|
72371670|NCT00669409|144253460|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|0.5|STANDARD_ERROR_OF_MEAN|8.25|||TWO_SIDED|95.0|-15.8|16.8||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||16.8|-15.8|
72371671|NCT00669409|144253460|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-7.5|STANDARD_ERROR_OF_MEAN|8.14|||TWO_SIDED|95.0|-23.6|8.6||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||8.6|-23.6|
72371672|NCT00669409|144253460|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-15.7|STANDARD_ERROR_OF_MEAN|10.75|||TWO_SIDED|95.0|-37.0|5.5||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||5.5|-37.0|
72371673|NCT00669409|144253461|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|9.0|STANDARD_ERROR_OF_MEAN|8.33|||TWO_SIDED|95.0|-7.4|25.5||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||25.5|-7.4|
72555099|NCT03086460|144641775|SUPERIORITY||Mean Difference (Final Values)|-0.005||||0.896|TWO_SIDED|95.0|-0.083|0.073|||ANCOVA|||"Day 14~Comparison groups were:~Treatment A (CHF 1531 pMDI 6 μg TDD) versus Treatment E (Placebo).~This secondary efficacy variable was analyzed using the ANCOVA model that was also used for the primary efficacy analysis, without adjusting for multiplicity."||0.073|-0.083|0.896
72617826|NCT03203512|144766668|SUPERIORITY||||||<|0.001||||||Treatment: p\<0.001; period: p=0.302; treatment x period interaction: p=0.385|ANOVA|||Null hypothesis is that there was no difference in change of DPA in plasma total phospholipids between fish oil and placebo capsules. A general linear model with fixed factors of treatment and period was conducted to determine the differences in the effect of two treatments and two periods on DPA in plasma total phospholipids.||||<0.001
72371674|NCT00669409|144253461|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-10.8|STANDARD_ERROR_OF_MEAN|8.25|||TWO_SIDED|95.0|-27.1|5.5||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||5.5|-27.1|
72371675|NCT00669409|144253461|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|8.25|||TWO_SIDED|95.0|-16.9|15.7||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||15.7|-16.9|
72371676|NCT00669409|144253461|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-7.8|STANDARD_ERROR_OF_MEAN|8.14|||TWO_SIDED|95.0|-23.9|8.4||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||8.4|-23.9|
72371677|NCT00669409|144253461|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-15.8|STANDARD_ERROR_OF_MEAN|10.75|||TWO_SIDED|95.0|-37.1|5.4||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||5.4|-37.1|
72371678|NCT00669409|144253462|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|11.4|STANDARD_ERROR_OF_MEAN|8.33|||TWO_SIDED|95.0|-5.1|27.9||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||27.9|-5.1|
72371679|NCT00669409|144253462|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-8.1|STANDARD_ERROR_OF_MEAN|8.25|||TWO_SIDED|95.0|-24.4|8.2||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||8.2|-24.4|
72371680|NCT00669409|144253462|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|2.1|STANDARD_ERROR_OF_MEAN|8.25|||TWO_SIDED|95.0|-14.2|18.4||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||18.4|-14.2|
72371681|NCT00669409|144253462|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-8.1|STANDARD_ERROR_OF_MEAN|8.16|||TWO_SIDED|95.0|-24.3|8.0||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||8.0|-24.3|
72371682|NCT00669409|144253462|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-6.4|STANDARD_ERROR_OF_MEAN|10.75|||TWO_SIDED|95.0|-27.6|14.9||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||14.9|-27.6|
72617827|NCT03203512|144766668|SUPERIORITY||||||<|0.001||||||Treatment: p\<0.001; period: p=0.793; treatment x period interaction: p=0.522|ANOVA|||Null hypothesis is that there was no difference in change of linoleic acid in plasma total phospholipids between fish oil and placebo capsules. A general linear model with fixed factors of treatment and period was conducted to determine the differences in the effect of two treatments and two periods on linoleic acid in plasma total phospholipids.||||<0.001
72617828|NCT03203512|144766668|SUPERIORITY||||||<|0.001||||||Treatment: p\<0.001; period: p=0.956; treatment x period interaction: p=0.238|ANOVA|||Null hypothesis is that there was no difference in change of dihomo-γ-linolenic acid (DGLA) in plasma total phospholipids between fish oil and placebo capsules. A general linear model with fixed factors of treatment and period was conducted to determine the differences in the effect of two treatments and two periods on DGLA in plasma total phospholipids.||||<0.001
72617829|NCT03203512|144766668|SUPERIORITY||||||<|0.001||||||Treatment: p\<0.001; period: p=0.457; treatment x period interaction: p=0.613|ANOVA|||Null hypothesis is that there was no difference in change of AA in plasma total phospholipids between fish oil and placebo capsules. A general linear model with fixed factors of treatment and period was conducted to determine the differences in the effect of two treatments and two periods on AA in plasma total phospholipids.||||<0.001
72617830|NCT03203512|144766668|SUPERIORITY||||||<|0.001||||||Treatment: p\<0.001; period: p=0.134; treatment x period interaction: p=0.260|ANOVA|||Null hypothesis is that there was no difference in change of total n-3 PUFA in plasma total phospholipids between fish oil and placebo capsules. A general linear model with fixed factors of treatment and period was conducted to determine the differences in the effect of two treatments and two periods on total n-3 PUFA in plasma total phospholipids.||||<0.001
72617831|NCT03203512|144766668|SUPERIORITY||||||<|0.001||||||Treatment: p\<0.001; period: p=0.917; treatment x period interaction: p=0.603|ANOVA|||Null hypothesis is that there was no difference in change of total n-6 PUFA in plasma total phospholipids between fish oil and placebo capsules. A general linear model with fixed factors of treatment and period was conducted to determine the differences in the effect of two treatments and two periods on total n-6 PUFA in plasma total phospholipids.||||<0.001
72617832|NCT03203512|144766669|SUPERIORITY||||||=|0.016||||||Treatment: p=0.016; period: p=0.566; treatment x period interaction: p=0.659|ANOVA|||Null hypothesis is that there was no difference in change of plasma TAG between fish oil and placebo capsules. A general linear model with fixed factors of treatment and period was conducted to determine the differences in the effect of two treatments and two periods on plasma TAG.||||=0.016
72617833|NCT03203512|144766669|SUPERIORITY||||||=|0.014||||||Treatment: p=0.014; period: p=0.842; treatment x period interaction: p=0.943|ANOVA|||Null hypothesis is that there was no difference in change of plasma LDL-C between fish oil and placebo capsules. A general linear model with fixed factors of treatment and period was conducted to determine the differences in the effect of two treatments and two periods on plasma LDL-C.||||=0.014
72617834|NCT03203512|144766669|SUPERIORITY||||||=|0.077||||||Treatment: p=0.077; period: p=0.921; treatment x period interaction: p=0.793|ANOVA|||Null hypothesis is that there was no difference in change of plasma TC between fish oil and placebo capsules. A general linear model with fixed factors of treatment and period was conducted to determine the differences in the effect of two treatments and two periods on plasma TC.||||=0.077
72617835|NCT03203512|144766669|SUPERIORITY||||||=|0.379||||||Treatment: p=0.379; period: p=0.938; treatment x period interaction: p=0.341|ANOVA|||Null hypothesis is that there was no difference in change of plasma HDL-C between fish oil and placebo capsules. A general linear model with fixed factors of treatment and period was conducted to determine the differences in the effect of two treatments and two periods on plasma HDL-C.||||=0.379
72617836|NCT03203512|144766670|SUPERIORITY||||||=|0.285||||||Treatment: p=0.285; period: p=0.954; treatment x period interaction: p=0.528|ANOVA|||Null hypothesis is that there was no difference in change of plasma TC/HDL-C ratio between fish oil and placebo capsules. A general linear model with fixed factors of treatment and period was conducted to determine the differences in the effect of two treatments and two periods on plasma TC/HDL-C ratio.||||=0.285
72617837|NCT03203512|144766671|SUPERIORITY||||||<|0.001||||||Treatment: p\<0.001; period effect: p=0.011; treatment x period interaction: p=0.033|ANOVA|||Null hypothesis is that there was no difference in change of SBP between fish oil and placebo capsules. A general linear model with fixed factors of treatment and period was conducted to determine the differences in the effect of two treatments and two periods on SBP.||||<0.001
72617838|NCT03203512|144766671|SUPERIORITY||||||=|0.002||||||Treatment: p=0.002; period: p=0.952; treatment x period interaction: p=0.114|ANOVA|||Null hypothesis is that there was no difference in change of DBP between fish oil and placebo capsules. A general linear model with fixed factors of treatment and period was conducted to determine the differences in the effect of two treatments and two periods on DBP.||||=0.002
72617839|NCT01145222|144766672|SUPERIORITY|Overall comparison between remimazolam and midazolam||||||0.007|||||||Fisher Exact|||||||0.007
72617840|NCT02933476|144766687|SUPERIORITY||||||>|0.05|||||||ANOVA|||We compared off therapy UPDRS III scores at baseline to one and four weeks after stimulation.||||>0.05
72617841|NCT02933476|144766688|SUPERIORITY|||||||0.008|||||||ANOVA|||||||0.008
72617842|NCT02933476|144766689|SUPERIORITY||||||<|0.001|||||||ANOVA|||||||<0.001
72617843|NCT00191152|144766752|SUPERIORITY_OR_OTHER|||||||0.145||95.0|||||Log Rank|||||||0.145
72617844|NCT00191152|144766753|SUPERIORITY_OR_OTHER|||||||0.361||95.0|||||Log Rank|||||||0.361
72617845|NCT00191152|144766754|SUPERIORITY_OR_OTHER|||||||0.145||95.0|||||Log Rank|||||||0.145
72617846|NCT00191152|144766755|SUPERIORITY_OR_OTHER|||||||0.385||95.0|||||Log Rank|||||||0.385
72617847|NCT00191152|144766756|SUPERIORITY_OR_OTHER|||||||0.377||95.0|||||Log Rank|||||||0.377
72617848|NCT00191152|144766757|SUPERIORITY_OR_OTHER|||||||0.446||95.0|||||Log Rank|||||||0.446
72617849|NCT00191152|144766758|SUPERIORITY_OR_OTHER|||||||0.785||95.0|||||Log Rank|||||||0.785
72617850|NCT00191152|144766759|SUPERIORITY_OR_OTHER|||||||0.364||95.0|||||Fisher Exact|||||||0.364
72617851|NCT00191152|144766760|SUPERIORITY_OR_OTHER|||||||0.446||95.0|||||Fisher Exact|||||||0.446
72617852|NCT00191152|144766761|SUPERIORITY_OR_OTHER|||||||0.99||95.0|||||Mixed Models Analysis|||||||0.990
72617853|NCT00191152|144766762|SUPERIORITY_OR_OTHER|||||||0.117||95.0|||||Mixed Models Analysis|||||||0.117
72617854|NCT00191152|144766763|SUPERIORITY_OR_OTHER|||||||0.801||95.0|||||Mixed Models Analysis|||||||0.801
72617855|NCT00191152|144766764|SUPERIORITY_OR_OTHER|||||||0.19||95.0|||||Mixed Models Analysis|||||||0.190
72617856|NCT00114777|144766765|SUPERIORITY_OR_OTHER||Treament Difference|1.1|||||TWO_SIDED|97.3|-7.2|9.4|||||The treatment differences between each belatacept treatment group and cyclosporin group was tested at the 0.027 significance level for participant and graft survival (based on 10% non-inferiority margin).|||9.4|-7.2|
72371683|NCT00669409|144253463|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-4.9|STANDARD_ERROR_OF_MEAN|8.44|||TWO_SIDED|95.0|-21.6|11.8||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||11.8|-21.6|
72371684|NCT00669409|144253463|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-19.5|STANDARD_ERROR_OF_MEAN|8.4|||TWO_SIDED|95.0|-36.1|-2.9||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-2.9|-36.1|
72371685|NCT00669409|144253463|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-5.2|STANDARD_ERROR_OF_MEAN|8.4|||TWO_SIDED|95.0|-21.8|11.4||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||11.4|-21.8|
72371686|NCT00669409|144253463|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-15.2|STANDARD_ERROR_OF_MEAN|8.3|||TWO_SIDED|95.0|-31.6|1.2||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||1.2|-31.6|
72371687|NCT00669409|144253463|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-40.8|STANDARD_ERROR_OF_MEAN|11.02|||TWO_SIDED|95.0|-62.6|-19.0||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-19.0|-62.6|
72371688|NCT00669409|144253464|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-4.2|STANDARD_ERROR_OF_MEAN|8.44|||TWO_SIDED|95.0|-20.9|12.5||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||12.5|-20.9|
72371689|NCT00669409|144253464|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-15.9|STANDARD_ERROR_OF_MEAN|8.4|||TWO_SIDED|95.0|-32.6|0.7||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||0.7|-32.6|
72371690|NCT00669409|144253464|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|3.5|STANDARD_ERROR_OF_MEAN|8.4|||TWO_SIDED|95.0|-13.2|20.1||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||20.1|-13.2|
72371691|NCT00669409|144253464|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-12.0|STANDARD_ERROR_OF_MEAN|8.3|||TWO_SIDED|95.0|-28.4|4.5||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||4.5|-28.4|
72371692|NCT00669409|144253464|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-17.0|STANDARD_ERROR_OF_MEAN|11.02|||TWO_SIDED|95.0|-38.8|4.8||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||4.8|-38.8|
72371693|NCT00669409|144253465|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-5.5|STANDARD_ERROR_OF_MEAN|8.44|||TWO_SIDED|95.0|-22.2|11.2||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||11.2|-22.2|
72371694|NCT00669409|144253465|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-19.5|STANDARD_ERROR_OF_MEAN|8.4|||TWO_SIDED|95.0|-36.1|-2.9||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-2.9|-36.1|
72371695|NCT00669409|144253465|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|1.1|STANDARD_ERROR_OF_MEAN|8.4|||TWO_SIDED|95.0|-15.6|17.7||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||17.7|-15.6|
72371696|NCT00669409|144253465|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-11.6|STANDARD_ERROR_OF_MEAN|8.3|||TWO_SIDED|95.0|-28.0|4.8||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||4.8|-28.0|
72371697|NCT00669409|144253465|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-8.3|STANDARD_ERROR_OF_MEAN|11.02|||TWO_SIDED|95.0|-30.1|13.5||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||13.5|-30.1|
72371698|NCT00669409|144253466|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-3.9|STANDARD_ERROR_OF_MEAN|8.44|||TWO_SIDED|95.0|-20.6|12.8||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||12.8|-20.6|
72371699|NCT00669409|144253466|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-19.0|STANDARD_ERROR_OF_MEAN|8.4|||TWO_SIDED|95.0|-35.6|-2.3||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-2.3|-35.6|
72617857|NCT00114777|144766765|SUPERIORITY_OR_OTHER||Treatment difference|3.2|||||TWO_SIDED|97.3|-5.0|11.4|||||The treatment differences between each belatacept treatment group and cyclosporin group was tested at the 0.027 significance level for participant and graft survival (based on 10% non-inferiority margin).|||11.4|-5.0|
72617858|NCT00114777|144766766|SUPERIORITY_OR_OTHER||Percentage difference|-14.4||||0.0018|TWO_SIDED|97.3|-24.0|-4.7|||Chi-squared||A continuity-corrected chi-squared test at the significance level 0.027 was performed to assess the effect of each belatacept regimen compared with cyclosporin A.|||-4.7|-24|0.0018
72555100|NCT03086460|144641775|SUPERIORITY||Mean Difference (Final Values)|-0.01||||0.81|TWO_SIDED|95.0|-0.089|0.07|||ANCOVA|||"Day 14~Comparison groups were:~Treatment B (CHF 1531 pMDI 12 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.070|-0.089|0.810
72617859|NCT00114777|144766766|SUPERIORITY_OR_OTHER||Percentage difference|-8.5||||0.0616|TWO_SIDED|97.3|-18.0|0.9|||Chi-squared||A continuity-corrected chi-squared test at the significance level 0.027 was performed to assess the effect of each belatacept regimen compared with cyclosporin A.|||0.9|-18|0.0616
72617860|NCT01543503|144766835|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.851|||<|0.001|TWO_SIDED|95.0|-1.112|-0.589|||ANCOVA|||Treatment Difference between Tocilizumab and TNF inhibitor: Analysis is based on an analysis of covariance (ANCOVA) model with change from baseline in DAS28-ESR at 24 weeks as dependent variable; therapy, site country, and treatment as fixed effects; DAS28-ESR at baseline as covariates.||-0.589|-1.112|<0.001
72617861|NCT01543503|144766836|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.91|||<|0.001|TWO_SIDED|95.0|-1.204|-0.617|||ANCOVA|||Treatment Difference between Tocilizumab and TNF inhibitor: Analysis is based on an ANCOVA model with change from baseline to 12 months in DAS28-ESR as dependent variable; therapy and treatment as fixed effects; DAS28-ESR at baseline as covariates.||-0.617|-1.204|<0.001
72617862|NCT01543503|144766837|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-13.23|||<|0.001|TWO_SIDED|95.0|-15.513|-10.947|||ANCOVA|||Treatment Difference between Tocilizumab and TNF inhibitor for ESR at Week 24: Analysis is based on an ANCOVA model with change from baseline to 6 months in ESR as a dependent variable; therapy and treatment as fixed effects; ESR at baseline as the covariate.||-10.947|-15.513|<0.001
72617863|NCT01543503|144766837|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-12.648|||<|0.001|TWO_SIDED|95.0|-15.419|-9.876|||ANCOVA|||Treatment Difference between Tocilizumab and TNF inhibitor for ESR at Week 52: Analysis is based on an ANCOVA model with change from baseline to 12 months in ESR, as the dependent variable; therapy and treatment as fixed effects; ESR at baseline as the covariate.||-9.876|-15.419|<0.001
72617864|NCT01543503|144766838|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-6.673|||<|0.001|TWO_SIDED|95.0|-10.271|-3.074|||ANCOVA|||Treatment Difference between Tocilizumab and TNF inhibitor for CRP at Week 24: Analysis is based on an ANCOVA model with change from baseline to 6 months in CRP as a dependent variable; therapy and treatment as fixed effects; CRP at baseline as the covariate.||-3.074|-10.271|<0.001
72617865|NCT01543503|144766838|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.116||||0.659|TWO_SIDED|95.0|-6.074|3.842|||ANCOVA|||Treatment Difference between Tocilizumab and TNF inhibitor for CRP at Week 52: Analysis is based on an ANCOVA model with change from baseline to 12 months in CRP as the dependent variable; therapy and treatment as fixed effects; CRP at baseline as the covariate.||3.842|-6.074|0.659
72617866|NCT01543503|144766839|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.576||||0.024|TWO_SIDED|95.0|-1.078|-0.075|||ANCOVA|||Treatment Difference between Tocilizumab and TNF inhibitor for SJC at Week 24: Analysis is based on an ANCOVA model with change from baseline to 6 months in SJC as the dependent variable; therapy and treatment as fixed effects; SJC at baseline as the covariate.||-0.075|-1.078|0.024
72555101|NCT03086460|144641775|SUPERIORITY||Mean Difference (Final Values)|-0.006||||0.882|TWO_SIDED|95.0|-0.084|0.073|||ANCOVA|||"Day 14~Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.073|-0.084|0.882
72617867|NCT01543503|144766839|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.752||||0.002|TWO_SIDED|95.0|-1.238|-0.267|||ANCOVA|||Treatment Difference between Tocilizumab and TNF inhibitor for SJC at Week 52: Analysis is based on an ANCOVA model with change from baseline to 12 months in SJC, as the dependent variable; therapy and treatment as fixed effects; SJC, at baseline as the covariate.||-0.267|-1.238|0.002
72617868|NCT01543503|144766840|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.62||||0.123|TWO_SIDED|95.0|-1.408|0.169|||ANCOVA|||Treatment Difference between Tocilizumab and TNF inhibitor for TJC at Week 24: Analysis is based on an ANCOVA model with change from baseline to 6 months in TJC as the dependent variable; therapy and treatment as fixed effects; TJC at baseline as the covariate.||0.169|-1.408|0.123
72617869|NCT01543503|144766840|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.216||||0.004|TWO_SIDED|95.0|-2.039|-0.393|||ANCOVA|||Treatment Difference between Tocilizumab and TNF inhibitor for TJC at Week 52: Analysis is based on an ANCOVA model with change from baseline to 12 months in TJC as the dependent variable; therapy and treatment as fixed effects; TJC at baseline as the covariate.||-0.393|-2.039|0.004
72617870|NCT01543503|144766841|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.475|||<|0.001|TWO_SIDED|95.0|-5.481|-1.469|||ANCOVA|||Treatment Difference between Tocilizumab and TNF inhibitor for CDAI score at Week 24: Analysis is based on an ANCOVA model with change from baseline to 6 months in CDAI the dependent variable; therapy and treatment as fixed effects; CDAI at baseline as the covariate.||-1.469|-5.481|<0.001
72617871|NCT01543503|144766841|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.6|||<|0.001|TWO_SIDED|95.0|-6.708|-2.492|||ANCOVA|||Treatment Difference between Tocilizumab and TNF inhibitor for CDAI score at Week 52: Analysis is based on an ANCOVA model with change from baseline to 12 months in CDAI as the dependent variable; therapy and treatment as fixed effects; CDAI at baseline as the covariate.||-2.492|-6.708|<0.001
72617872|NCT01543503|144766841|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.229||||0.014|TWO_SIDED|95.0|-5.806|-0.652|||ANCOVA|||Treatment Difference between Tocilizumab and TNF inhibitor for SDAI score at Week 24: Analysis is based on an ANCOVA model with change from baseline to 6 months in SDAI as the dependent variable; therapy and treatment as fixed effects; SDAI at baseline as the covariate.||-0.652|-5.806|0.014
72617873|NCT01543503|144766841|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.245||||0.027|TWO_SIDED|95.0|-6.121|-0.37|||ANCOVA|||Treatment Difference between Tocilizumab and TNF inhibitor for SDAI score at Week 52: Analysis is based on an ANCOVA model with change from baseline to 12 months in SDAI as the dependent variable; therapy and treatment as fixed effects; SDAI at baseline as the covariate.||-0.370|-6.121|0.027
72617874|NCT01543503|144766842|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-9.03|||<|0.001|TWO_SIDED|95.0|-12.655|-5.404|||ANCOVA|||Treatment Difference between Tocilizumab and TNF inhibitor for Physician Global Assessment score at Week 24: Analysis is based on an ANCOVA model with change from baseline to 6 months in Physician Global Assessment of Disease Activity as the dependent variable; therapy and treatment as fixed effects; Physician Global Assessment of Disease Activity at baseline as covariates.||-5.404|-12.655|<0.001
72617875|NCT01543503|144766842|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-10.237|||<|0.001|TWO_SIDED|95.0|-14.13|-6.345|||ANCOVA|||Treatment Difference between Tocilizumab and TNF inhibitor for Physician Global Assessment score at Week 52: Analysis is based on an ANCOVA model with change from baseline to 12 months in Physician Global Assessment of Disease Activity as the dependent variable; therapy and treatment as fixed effects; Physician Global Assessment of Disease Activity at baseline as covariates.||-6.345|-14.130|<0.001
72617876|NCT01543503|144766846|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Log Rank|||||||<0.001
72617877|NCT01543503|144766850|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.146||||0.02|TWO_SIDED|95.0|-0.269|-0.024|||ANCOVA|||Treatment Difference between Tocilizumab and TNF inhibitor at Week 24: Analysis is based on an ANCOVA model with change from baseline to 6 months in HAQ-DI as dependent variable; therapy and treatment as fixed effects; HAQ-DI at baseline as covariates.||-0.024|-0.269|0.020
72617878|NCT01543503|144766850|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.164||||0.02|TWO_SIDED|95.0|-0.301|-0.026|||ANCOVA|||Treatment Difference between Tocilizumab and TNF inhibitor at Week 52: Analysis is based on an ANCOVA model with change from baseline to 12 months in HAQ-DI as dependent variable; therapy and treatment as fixed effects; HAQ-DI at baseline as covariates.||-0.026|-0.301|0.020
72617879|NCT01543503|144766851|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.893||||0.032|TWO_SIDED|95.0|-7.457|-0.329|||ANCOVA|||Treatment Difference between Tocilizumab and TNF inhibitor at Week 24: Analysis is based on an ANCOVA model with change from baseline to 6 months in FACIT-F score as dependent variable; therapy and treatment as fixed effects; FACIT-F score at baseline as covariates.||-0.329|-7.457|0.032
72617880|NCT01543503|144766851|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.787||||0.168|TWO_SIDED|95.0|-6.763|1.189|||ANCOVA|||Treatment Difference between Tocilizumab and TNF inhibitor for Week 52: Analysis is based on an ANCOVA model with change from baseline to 12 months in FACIT-F score as dependent variable; therapy and treatment as fixed effects; FACIT-F score at baseline as covariates.||1.189|-6.763|0.168
72617881|NCT01543503|144766852|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.661||||0.009|TWO_SIDED|95.0|-9.912|-1.411|||ANCOVA|||Treatment Difference between Tocilizumab and TNF inhibitor at Week 24: Analysis is based on an ANCOVA model with change from baseline to 6 months in participant's VAS score as dependent variable; therapy and treatment as fixed effects; participant's VAS score at baseline as covariates.||-1.411|-9.912|0.009
72617882|NCT01543503|144766852|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-9.802|||<|0.001|TWO_SIDED|95.0|-14.245|-5.36|||ANCOVA|||Treatment Difference between Tocilizumab and TNF inhibitor at Week 52: Analysis is based on an ANCOVA model with change from baseline to 12 months in participant's VAS score as dependent variable; therapy and treatment as fixed effects; participant's VAS score at baseline as covariates.||-5.360|-14.245|<0.001
72617883|NCT01543503|144766854|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.108||||0.01|TWO_SIDED|95.0|-9.017|-1.2|||ANCOVA|||Treatment Difference between Tocilizumab and TNF inhibitor at Week 24: Analysis is based on an ANCOVA model with change from baseline to 6 months in Patient's Global Assessment of Disease as dependent variable; therapy and treatment as fixed effects; Patient's Global Assessment of Disease at baseline as covariates.||-1.200|-9.017|0.010
72617884|NCT01543503|144766854|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-7.767|||<|0.001|TWO_SIDED|95.0|-12.161|-3.372|||ANCOVA|||Treatment Difference between Tocilizumab and TNF inhibitor at Week 52: Analysis is based on an ANCOVA model with change from baseline to 12 months in Patient's Global Assessment of Disease as dependent variable; therapy and treatment as fixed effects; Patient's Global Assessment of Disease at baseline as covariates.||-3.372|-12.161|<0.001
72617885|NCT00682838|144766855|SUPERIORITY_OR_OTHER|||||||0.5|||||||t-test, 1 sided|||||||0.50
72617886|NCT03467945|144766899|EQUIVALENCE|Bioequivalence boundaries of 80.000% to 125.00% were used.|Geometric Least Squares Mean Ratio|81.4421|||||TWO_SIDED|90.0|75.2805|88.1079||||||||88.1079|75.2805|
72617887|NCT03467945|144766899|EQUIVALENCE|Bioequivalence boundaries of 80.000% to 125.00% were used.|Geometric Least Squares Mean Ratio|102.293|||||TWO_SIDED|90.0|97.8819|106.9028||||||||106.9028|97.8819|
72617888|NCT03467945|144766899|EQUIVALENCE|Bioequivalence boundaries of 80.000% to 125.00% were used.|Geometric Least Squares Mean Ratio|81.0112|||||TWO_SIDED|90.0|74.8823|87.6417||||||||87.6417|74.8823|
72617889|NCT03467945|144766900|EQUIVALENCE|Bioequivalence boundaries of 80.000% to 125.00% were used.|Geometric Least Squares Mean Ratio|102.293|||||TWO_SIDED|90.0|97.8819|106.9028||||||||106.9028|97.8819|
72617890|NCT03467945|144766900|EQUIVALENCE|Bioequivalence boundaries of 80.000% to 125.00% were used.|Geometric Least Squares Mean Ratio|105.7255|||||TWO_SIDED|90.0|101.1665|110.49||||||||110.4900|101.1665|
72617891|NCT03467945|144766900|EQUIVALENCE|Bioequivalence boundaries of 80.000% to 125.00% were used.|Geometric Least Squares Mean Ratio|96.7533|||||TWO_SIDED|90.0|92.5812|101.1135||||||||101.1135|92.5812|
72617892|NCT03467945|144766901|EQUIVALENCE|Bioequivalence boundaries of 80.000% to 125.00% were used.|Geometric Least Squares Mean Ratio|77.6923|||||TWO_SIDED|90.0|70.383|85.7606||||||||85.7606|70.3830|
72617893|NCT03467945|144766901|EQUIVALENCE|Bioequivalence boundaries of 80.000% to 125.00% were used.|Geometric Least Squares Mean Ratio|108.0819|||||TWO_SIDED|90.0|102.237|114.2609||||||||114.2609|102.2370|
72617894|NCT03467945|144766901|EQUIVALENCE|Bioequivalence boundaries of 80.000% to 125.00% were used.|Geometric Least Squares Mean Ratio|79.4367|||||TWO_SIDED|90.0|71.9633|87.6861||||||||87.6861|71.9633|
72617895|NCT03467945|144766902|EQUIVALENCE|Bioequivalence boundaries of 80.000% to 125.00% were used.|Geometric Least Squares Mean Ratio|108.0819|||||TWO_SIDED|90.0|102.237|114.2609||||||||114.2609|102.2370|
72371700|NCT00669409|144253466|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-2.9|STANDARD_ERROR_OF_MEAN|8.4|||TWO_SIDED|95.0|-19.6|13.7||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||13.7|-19.6|
72371701|NCT00669409|144253466|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-14.5|STANDARD_ERROR_OF_MEAN|8.3|||TWO_SIDED|95.0|-30.9|1.9||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||1.9|-30.9|
72371702|NCT00669409|144253466|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-29.4|STANDARD_ERROR_OF_MEAN|11.02|||TWO_SIDED|95.0|-51.2|-7.6||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-7.6|-51.2|
72371703|NCT00669409|144253467|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|0.4|STANDARD_ERROR_OF_MEAN|8.44|||TWO_SIDED|95.0|-16.3|17.1||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||17.1|-16.3|
72371704|NCT00669409|144253467|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-18.8|STANDARD_ERROR_OF_MEAN|8.4|||TWO_SIDED|95.0|-35.4|-2.2||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-2.2|-35.4|
72371705|NCT00669409|144253467|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-7.5|STANDARD_ERROR_OF_MEAN|8.4|||TWO_SIDED|95.0|-24.1|9.1||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||9.1|-24.1|
72371706|NCT00669409|144253467|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-15.5|STANDARD_ERROR_OF_MEAN|8.3|||TWO_SIDED|95.0|-31.9|0.9||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||0.9|-31.9|
72371707|NCT00669409|144253467|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-31.3|STANDARD_ERROR_OF_MEAN|11.02|||TWO_SIDED|95.0|-53.1|-9.5||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-9.5|-53.1|
72371708|NCT00669409|144253468|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|8.44|||TWO_SIDED|95.0|-16.9|16.5||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||16.5|-16.9|
72371709|NCT00669409|144253468|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-20.0|STANDARD_ERROR_OF_MEAN|8.4|||TWO_SIDED|95.0|-36.7|-3.4||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-3.4|-36.7|
72371710|NCT00669409|144253468|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-7.6|STANDARD_ERROR_OF_MEAN|8.4|||TWO_SIDED|95.0|-24.2|9.0||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||9.0|-24.2|
72371711|NCT00669409|144253468|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-13.4|STANDARD_ERROR_OF_MEAN|8.3|||TWO_SIDED|95.0|-29.8|3.0||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||3.0|-29.8|
72371712|NCT00669409|144253468|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-33.8|STANDARD_ERROR_OF_MEAN|11.02|||TWO_SIDED|95.0|-55.6|-12.0||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-12.0|-55.6|
72371713|NCT00669409|144253469|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|3.8|STANDARD_ERROR_OF_MEAN|8.44|||TWO_SIDED|95.0|-12.9|20.4||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||20.4|-12.9|
72555102|NCT03086460|144641775|SUPERIORITY||Mean Difference (Final Values)|0.06||||0.115|TWO_SIDED|95.0|-0.015|0.136|||ANCOVA|||"Day 14~Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.136|-0.015|0.115
72617896|NCT03467945|144766902|EQUIVALENCE|Bioequivalence boundaries of 80.000% to 125.00% were used.|Geometric Least Squares Mean Ratio|93.6828|||||TWO_SIDED|90.0|88.6166|99.0386||||||||99.0386|88.6166|
72371714|NCT00669409|144253469|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-19.9|STANDARD_ERROR_OF_MEAN|8.4|||TWO_SIDED|95.0|-36.5|-3.3||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-3.3|-36.5|
72371715|NCT00669409|144253469|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-6.7|STANDARD_ERROR_OF_MEAN|8.4|||TWO_SIDED|95.0|-23.3|10.0||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||10.0|-23.3|
72371716|NCT00669409|144253469|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-14.8|STANDARD_ERROR_OF_MEAN|8.3|||TWO_SIDED|95.0|-31.2|1.6||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||1.6|-31.2|
72555103|NCT03086460|144641775|SUPERIORITY||Mean Difference (Final Values)|0.06||||0.111|TWO_SIDED|95.0|-0.014|0.134|||ANCOVA|||"Day 14~Comparison groups were:~Treatment F ( Perforomist® IS 40 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.134|-0.014|0.111
72617897|NCT03467945|144766902|EQUIVALENCE|Bioequivalence boundaries of 80.000% to 125.00% were used.|Geometric Least Squares Mean Ratio|115.37|||||TWO_SIDED|90.0|109.131|121.9658||||||||121.9658|109.1310|
72371717|NCT00669409|144253469|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-28.2|STANDARD_ERROR_OF_MEAN|11.02|||TWO_SIDED|95.0|-50.0|-6.4||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-6.4|-50.0|
72371718|NCT00669409|144253470|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|7.3|STANDARD_ERROR_OF_MEAN|8.44|||TWO_SIDED|95.0|-9.4|24.0||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||24.0|-9.4|
72371719|NCT00669409|144253470|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-17.8|STANDARD_ERROR_OF_MEAN|8.4|||TWO_SIDED|95.0|-34.4|-1.2||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-1.2|-34.4|
72617898|NCT03467945|144766903|EQUIVALENCE|Bioequivalence boundaries of 80.000% to 125.00% were used.|Geometric Least Squares Mean Ratio|82.6022|||||TWO_SIDED|90.0|76.5513|89.1314||||||||89.1314|76.5513|
72371720|NCT00669409|144253470|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-3.4|STANDARD_ERROR_OF_MEAN|8.4|||TWO_SIDED|95.0|-20.0|13.2||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||13.2|-20.0|
72371721|NCT00669409|144253470|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-13.5|STANDARD_ERROR_OF_MEAN|8.3|||TWO_SIDED|95.0|-29.9|2.9||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||2.9|-29.9|
72371722|NCT00669409|144253470|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-28.5|STANDARD_ERROR_OF_MEAN|11.02|||TWO_SIDED|95.0|-50.3|-6.7||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-6.7|-50.3|
72371723|NCT00669409|144253471|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|12.4|STANDARD_ERROR_OF_MEAN|8.44|||TWO_SIDED|95.0|-4.3|29.1||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||29.1|-4.3|
72371724|NCT00669409|144253471|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-14.8|STANDARD_ERROR_OF_MEAN|8.4|||TWO_SIDED|95.0|-31.4|1.9||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||1.9|-31.4|
72371725|NCT00669409|144253471|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|2.0|STANDARD_ERROR_OF_MEAN|8.4|||TWO_SIDED|95.0|-14.6|18.6||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||18.6|-14.6|
72371726|NCT00669409|144253471|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-8.6|STANDARD_ERROR_OF_MEAN|8.3|||TWO_SIDED|95.0|-25.0|7.8||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||7.8|-25.0|
72371727|NCT00669409|144253471|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-23.1|STANDARD_ERROR_OF_MEAN|11.02|||TWO_SIDED|95.0|-44.9|-1.3||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-1.3|-44.9|
72371728|NCT00669409|144253472|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|11.6|STANDARD_ERROR_OF_MEAN|8.44|||TWO_SIDED|95.0|-5.1|28.3||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||28.3|-5.1|
72617899|NCT03467945|144766903|EQUIVALENCE|Bioequivalence boundaries of 80.000% to 125.00% were used.|Geometric Least Squares Mean Ratio|101.8499|||||TWO_SIDED|90.0|97.8819|106.9028||||||||106.9028|97.8819|
72371729|NCT00669409|144253472|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-15.5|STANDARD_ERROR_OF_MEAN|8.4|||TWO_SIDED|95.0|-32.1|1.1||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||1.1|-32.1|
72371730|NCT00669409|144253472|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|3.1|STANDARD_ERROR_OF_MEAN|8.4|||TWO_SIDED|95.0|-13.5|19.7||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||19.7|-13.5|
72371731|NCT00669409|144253472|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-6.7|STANDARD_ERROR_OF_MEAN|8.3|||TWO_SIDED|95.0|-23.1|9.7||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||9.7|-23.1|
72371732|NCT00669409|144253472|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-18.9|STANDARD_ERROR_OF_MEAN|11.02|||TWO_SIDED|95.0|-40.7|2.9||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||2.9|-40.7|
72371733|NCT00669409|144253473|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|12.3|STANDARD_ERROR_OF_MEAN|8.44|||TWO_SIDED|95.0|-4.4|29.0||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||29.0|-4.4|
72371734|NCT00669409|144253473|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-11.2|STANDARD_ERROR_OF_MEAN|8.4|||TWO_SIDED|95.0|-27.8|5.4||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||5.4|-27.8|
72371735|NCT00669409|144253473|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|3.5|STANDARD_ERROR_OF_MEAN|8.4|||TWO_SIDED|95.0|-13.2|20.1||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||20.1|-13.2|
72371736|NCT00669409|144253473|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-7.5|STANDARD_ERROR_OF_MEAN|8.3|||TWO_SIDED|95.0|-23.9|9.0||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||9.0|-23.9|
72371737|NCT00669409|144253473|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-18.6|STANDARD_ERROR_OF_MEAN|11.02|||TWO_SIDED|95.0|-40.4|3.2||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||3.2|-40.4|
72617900|NCT03467945|144766903|EQUIVALENCE|Bioequivalence boundaries of 80.000% to 125.00% were used.|Geometric Least Squares Mean Ratio|81.0112|||||TWO_SIDED|90.0|74.8823|87.6417||||||||87.6417|74.8823|
72617901|NCT03467945|144766904|EQUIVALENCE|Bioequivalence boundaries of 80.000% to 125.00% were used.|Geometric Least Squares Mean Ratio|101.8499|||||TWO_SIDED|90.0|97.5947|106.2906||||||||106.2906|97.5947|
72617902|NCT03467945|144766904|EQUIVALENCE|Bioequivalence boundaries of 80.000% to 125.00% were used.|Geometric Least Squares Mean Ratio|105.915|||||TWO_SIDED|90.0|101.49|110.533||||||||110.5330|101.4900|
72371738|NCT00669409|144253474|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|11.2|STANDARD_ERROR_OF_MEAN|8.44|||TWO_SIDED|95.0|-5.5|27.9||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||27.9|-5.5|
72371739|NCT00669409|144253474|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-9.6|STANDARD_ERROR_OF_MEAN|8.4|||TWO_SIDED|95.0|-26.3|7.0||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||7.0|-26.3|
72371740|NCT00669409|144253474|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|1.9|STANDARD_ERROR_OF_MEAN|8.4|||TWO_SIDED|95.0|-14.7|18.5||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||18.5|-14.7|
72371741|NCT00669409|144253474|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-7.2|STANDARD_ERROR_OF_MEAN|8.3|||TWO_SIDED|95.0|-23.6|9.2||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||9.2|-23.6|
72371742|NCT00669409|144253474|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-20.4|STANDARD_ERROR_OF_MEAN|11.02|||TWO_SIDED|95.0|-42.2|1.4||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||1.4|-42.2|
72371743|NCT00669409|144253475|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|13.5|STANDARD_ERROR_OF_MEAN|8.44|||TWO_SIDED|95.0|-3.2|30.2||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||30.2|-3.2|
72371744|NCT00669409|144253475|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-6.7|STANDARD_ERROR_OF_MEAN|8.4|||TWO_SIDED|95.0|-23.3|9.9||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||9.9|-23.3|
72371745|NCT00669409|144253475|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|5.1|STANDARD_ERROR_OF_MEAN|8.4|||TWO_SIDED|95.0|-11.5|21.7||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||21.7|-11.5|
72371746|NCT00669409|144253475|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-7.6|STANDARD_ERROR_OF_MEAN|8.31|||TWO_SIDED|95.0|-24.1|8.8||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||8.8|-24.1|
72371747|NCT00669409|144253475|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-9.8|STANDARD_ERROR_OF_MEAN|11.02|||TWO_SIDED|95.0|-31.6|12.0||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||12.0|-31.6|
72371748|NCT00669409|144253476|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-9.2|STANDARD_ERROR_OF_MEAN|7.86|||TWO_SIDED|95.0|-24.7|6.4||||||Change at Week 1, Pain: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||6.4|-24.7|
72371749|NCT00669409|144253476|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-20.4|STANDARD_ERROR_OF_MEAN|7.86|||TWO_SIDED|95.0|-36.0|-4.9||||||Change at Week 1, Pain: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-4.9|-36.0|
72555104|NCT03086460|144641775|SUPERIORITY||Mean Difference (Final Values)|-0.004||||0.911|TWO_SIDED|95.0|-0.083|0.074|||ANCOVA|||"Day 14~Comparison groups were:~Treatment B (CHF 1531 pMDI 12 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.074|-0.083|0.911
72617903|NCT03467945|144766904|EQUIVALENCE|Bioequivalence boundaries of 80.000% to 125.00% were used.|Geometric Least Squares Mean Ratio|96.1619|||||TWO_SIDED|90.0|92.1443|100.3546||||||||100.3546|92.1443|
72617904|NCT01740427|144766987|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.576|||<|1e-06|TWO_SIDED|95.0|0.463|0.718||1-sided p-value from the stratified log-rank test.|Stratified Log Rank|||||0.718|0.463|<0.000001
72371750|NCT00669409|144253476|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-4.2|STANDARD_ERROR_OF_MEAN|7.92|||TWO_SIDED|95.0|-19.9|11.4||||||Change at Week 1, Pain: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||11.4|-19.9|
72371751|NCT00669409|144253476|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-15.7|STANDARD_ERROR_OF_MEAN|7.73|||TWO_SIDED|95.0|-30.9|-0.4||||||Change at Week 1, Pain: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-0.4|-30.9|
72371752|NCT00669409|144253476|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-29.1|STANDARD_ERROR_OF_MEAN|10.25|||TWO_SIDED|95.0|-49.4|-8.9||||||Change at Week 1, Pain: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-8.9|-49.4|
72371753|NCT00669409|144253476|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-1.3|STANDARD_ERROR_OF_MEAN|7.89|||TWO_SIDED|95.0|-16.9|14.3||||||Change at Week 1, Physical Functions: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||14.3|-16.9|
72371754|NCT00669409|144253476|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-13.9|STANDARD_ERROR_OF_MEAN|7.89|||TWO_SIDED|95.0|-29.5|1.7||||||Change at Week 1, Physical Functions: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||1.7|-29.5|
72371755|NCT00669409|144253476|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|0.6|STANDARD_ERROR_OF_MEAN|8.06|||TWO_SIDED|95.0|-15.4|16.5||||||Change at Week 1, Physical Functions: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||16.5|-15.4|
72371756|NCT00669409|144253476|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-11.8|STANDARD_ERROR_OF_MEAN|7.83|||TWO_SIDED|95.0|-27.3|3.7||||||Change at Week 1, Physical Functions: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||3.7|-27.3|
72371757|NCT00669409|144253476|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-22.7|STANDARD_ERROR_OF_MEAN|10.3|||TWO_SIDED|95.0|-43.1|-2.4||||||Change at Week 1, Physical Functions: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-2.4|-43.1|
72617905|NCT01740427|144766988|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.428||||0.0224|TWO_SIDED|95.0|1.008|2.03||1-sided p-value is from exact test.|Fisher Exact|||Stratified analysis: Stratified by disease site (visceral vs non-visceral) per randomization.||2.030|1.008|0.0224
72617906|NCT01740427|144766989|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.594||||0.009|TWO_SIDED|95.0|1.08|2.347||1-sided p-value is from exact test.|Fisher Exact|||Stratified analysis: Stratified by disease site (visceral vs non-visceral) per randomization.||2.347|1.080|0.0090
72617907|NCT01740427|144766991|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.451|||<|0.0001|TWO_SIDED|95.0|1.619|3.722||1-sided p-value is from exact test.|Fisher Exact|||Stratified analysis: Stratified by disease site (visceral, non-visceral) per randomization.||3.722|1.619|<0.0001
72617908|NCT01740427|144766992|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.571|||<|0.0001|TWO_SIDED|95.0|0.443|0.737|||Unstratified log-rank test||Unstratified Cox proportional hazards model was used.|Statistical analysis for ER positive||0.737|0.443|<0.0001
72617909|NCT01740427|144766992|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.405||||0.003|TWO_SIDED|95.0|0.218|0.751|||Unstratified log-rank test||Unstratified Cox proportional hazards model was used.|Statistical analysis for ER Negative||0.751|0.218|0.0030
72617910|NCT01740427|144766992|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.531|||<|0.0001|TWO_SIDED|95.0|0.416|0.68|||Unstratified log-rank test||Unstratified Cox proportional hazards model was used.|Statistical analysis for Rb Positive||0.680|0.416|<0.0001
72617911|NCT01740427|144766992|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.675||||0.3237|TWO_SIDED|95.0|0.308|1.481|||Unstratified log-rank test||Unstratified Cox proportional hazards model was used.|Statistical analysis for Rb Negative||1.481|0.308|0.3237
72617912|NCT01740427|144766992|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.555|||<|0.0001|TWO_SIDED|95.0|0.437|0.705|||Unstratified log-rank test||Unstratified Cox proportional hazards model was used.|Statistical analysis for Cyclin D1 Positive||0.705|0.437|<0.0001
72617913|NCT01740427|144766992|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.997||||0.9964|TWO_SIDED|95.0|0.287|3.461|||Unstratified log-rank test||Unstratified Cox proportional hazards model was used.|Statistical analysis for Cyclin D1 Negative||3.461|0.287|0.9964
72617914|NCT01740427|144766992|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.518|||<|0.0001|TWO_SIDED|95.0|0.4|0.67|||Unstratified log-rank test||Unstratified Cox proportional hazards model was used.|Statistical analysis for p16 Positive||0.670|0.400|<0.0001
72617915|NCT01740427|144766992|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.731||||0.3221|TWO_SIDED|95.0|0.392|1.364|||Unstratified log-rank test||Unstratified Cox proportional hazards model was used.|Statistical analysis for p16 Negative||1.364|0.392|0.3221
72617916|NCT01740427|144766992|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.581|||<|0.0001|TWO_SIDED|95.0|0.455|0.742|||Unstratified log-rank test||Unstratified Cox proportional hazards model was used.|Statistical analysis for p16 HScore\<175||0.742|0.455|<0.0001
72617917|NCT01740427|144766992|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.255||||0.0022|TWO_SIDED|95.0|0.1|0.65|||Unstratified log-rank test||Unstratified Cox proportional hazards model was used.|Statistical analysis for p16 HScore\>=175||0.650|0.100|0.0022
72617918|NCT01740427|144766992|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.53||||0.0002|TWO_SIDED|95.0|0.379|0.742|||Unstratified log-rank test||Unstratified Cox proportional hazards model was used.|Statistical analysis for Ki67 \<=20%||0.742|0.379|0.0002
72617919|NCT01740427|144766992|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.569||||0.0007|TWO_SIDED|95.0|0.409|0.791|||Unstratified log-rank test||Unstratified Cox proportional hazards model was used.|Statistical analysis for Ki67 \>20%||0.791|0.409|0.0007
72617920|NCT01740427|144766996|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.023||||0.0925|TWO_SIDED|95.0|-0.004|0.051|||Mixed Models Analysis|Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.||||0.051|-0.004|0.0925
72617921|NCT01740427|144766997|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.325||||0.7822|TWO_SIDED|95.0|-2.63|1.98|||Mixed Models Analysis|Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.||||1.98|-2.63|0.7822
72617922|NCT01740427|144766999|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.956||||0.33775|TWO_SIDED|95.0|0.777|1.177||1-sided p-value from the stratified log-rank test.|Stratified Log Rank|||||1.177|0.777|0.337750
72617923|NCT01740427|144767000|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.921||||0.208706|TWO_SIDED|95.0|0.755|1.124||1-sided p-value from the stratified log-rank test.|Stratified Log Rank|||||1.124|0.755|0.208706
72617924|NCT00165698|144767009|SUPERIORITY_OR_OTHER|||||||0.26||95.0|||||Symbols rank sum test|||||||0.26
72617925|NCT00165698|144767010|SUPERIORITY_OR_OTHER|||||||0.19||95.0|||||Symbols rank sum test|||||||0.19
72617926|NCT00165698|144767011|SUPERIORITY_OR_OTHER|||||||0.31||95.0|||||Symbols rank sum test|||||||0.31
72617927|NCT00165698|144767012|SUPERIORITY_OR_OTHER|||||||0.869||95.0|||||symbols rank sum test|||||||0.869
72617928|NCT00165698|144767013|SUPERIORITY_OR_OTHER|||||||0.174||95.0|||||symbols rank sum test|||||||0.174
72617929|NCT00165698|144767014|SUPERIORITY_OR_OTHER|||||||0||95.0|||||symbols rank sum test|||||||0.000
72617930|NCT00165698|144767015|SUPERIORITY_OR_OTHER|||||||0||95.0|||||symbols rank sum test|||||||0.000
72617931|NCT00165698|144767016|SUPERIORITY_OR_OTHER|||||||0||95.0|||||symbols rank sum test|||||||0.000
72617932|NCT01107457|144767019|SUPERIORITY_OR_OTHER_LEGACY|||||||0.079|TWO_SIDED||||||Fisher Exact|||||||0.079
72617933|NCT01107457|144767019|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Fisher Exact|||||||<0.001
72617934|NCT01107457|144767019|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Fisher Exact|||||||<0.001
72617935|NCT01107457|144767019|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Fisher Exact|||||||<0.001
72617936|NCT01107457|144767020|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
72617937|NCT01107457|144767020|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
72617938|NCT01107457|144767020|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
72617939|NCT01107457|144767020|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
72617940|NCT05067270|144767061|OTHER||Geometric Least Squares Mean Ratio|1.77|||||TWO_SIDED|95.0|1.3|2.4||||||1 min post bolus (Bolus time: 3 hours)||2.40|1.30|
72617941|NCT05067270|144767061|OTHER||Geometric Least Squares Mean Ratio|1.91|||||TWO_SIDED|95.0|1.42|2.59||||||1 min post bolus (Bolus time: 3 hours)||2.59|1.42|
72617942|NCT05067270|144767061|OTHER||Geometric Least Squares Mean Ratio|1.84|||||TWO_SIDED|95.0|1.37|2.49||||||1 min post bolus (Bolus time: 3 hours)||2.49|1.37|
72617943|NCT05067270|144767061|OTHER||Geometric Least Squares Mean Ratio|1.42|||||TWO_SIDED|95.0|1.05|1.92||||||1 min post bolus (Bolus time: 3 hours)||1.92|1.05|
72617944|NCT05067270|144767061|OTHER||Geometric Least Squares Mean Ratio|1.08|||||TWO_SIDED|95.0|0.8|1.46||||||1 min post bolus (Bolus time: 3 hours)||1.46|0.80|
72617945|NCT05067270|144767061|OTHER||Geometric Least Squares Mean Ratio|1.04|||||TWO_SIDED|95.0|0.77|1.41||||||1 min post bolus (Bolus time: 3 hours)||1.41|0.77|
72617946|NCT05067270|144767061|OTHER||Geometric Least Squares Mean Ratio|0.8|||||TWO_SIDED|95.0|0.59|1.08||||||1 min post bolus (Bolus time: 3 hours)||1.08|0.59|
72617947|NCT05067270|144767061|OTHER||Geometric Least Squares Mean Ratio|0.96|||||TWO_SIDED|95.0|0.72|1.3||||||1 min post bolus (Bolus time: 3 hours)||1.30|0.72|
72617948|NCT05067270|144767061|OTHER||Geometric Least Squares Mean Ratio|0.74|||||TWO_SIDED|95.0|0.55|1.0||||||1 min post bolus (Bolus time: 3 hours)||1.00|0.55|
72617949|NCT05067270|144767061|OTHER||Geometric Least Squares Mean Ratio|0.77|||||TWO_SIDED|95.0|0.57|1.04||||||1 min post bolus (Bolus time: 3 hours)||1.04|0.57|
72617950|NCT05067270|144767061|OTHER||Geometric Least Squares Mean Ratio|1.49|||||TWO_SIDED|95.0|1.09|2.02||||||1 min post bolus (Bolus time: 6 hours)||2.02|1.09|
72617951|NCT05067270|144767061|OTHER||Geometric Least Squares Mean Ratio|1.68|||||TWO_SIDED|95.0|1.25|2.28||||||1 min post bolus (Bolus time: 6 hours)||2.28|1.25|
72617952|NCT05067270|144767061|OTHER||Geometric Least Squares Mean Ratio|1.84|||||TWO_SIDED|95.0|1.36|2.48||||||1 min post bolus (Bolus time: 6 hours)||2.48|1.36|
72617953|NCT05067270|144767061|OTHER||Geometric Least Squares Mean Ratio|1.16|||||TWO_SIDED|95.0|0.85|1.56||||||1 min post bolus (Bolus time: 6 hours)||1.56|0.85|
72617954|NCT05067270|144767061|OTHER||Geometric Least Squares Mean Ratio|1.13|||||TWO_SIDED|95.0|0.83|1.54||||||1 min post bolus (Bolus time: 6 hours)||1.54|0.83|
72617955|NCT05067270|144767061|OTHER||Geometric Least Squares Mean Ratio|1.24|||||TWO_SIDED|95.0|0.91|1.68||||||1 min post bolus (Bolus time: 6 hours)||1.68|0.91|
72432393|NCT02696785|144377183|SUPERIORITY||LSMean Difference|-1.1|STANDARD_ERROR_OF_MEAN|0.76||0.166|TWO_SIDED|95.0|-2.6|0.4|||Mixed Models Analysis|||||0.4|-2.6|0.166
72617956|NCT05067270|144767061|OTHER||Geometric Least Squares Mean Ratio|0.78|||||TWO_SIDED|95.0|0.57|1.05||||||1 min post bolus (Bolus time: 6 hours)||1.05|0.57|
72617957|NCT05067270|144767061|OTHER||Geometric Least Squares Mean Ratio|1.09|||||TWO_SIDED|95.0|0.81|1.47||||||1 min post bolus (Bolus time: 6 hours)||1.47|0.81|
72617958|NCT05067270|144767061|OTHER||Geometric Least Squares Mean Ratio|0.69|||||TWO_SIDED|95.0|0.51|0.93||||||1 min post bolus (Bolus time: 6 hours)||0.93|0.51|
72617959|NCT05067270|144767061|OTHER||Geometric Least Squares Mean Ratio|0.63|||||TWO_SIDED|95.0|0.47|0.85||||||1 min post bolus (Bolus time: 6 hours)||0.85|0.47|
72617960|NCT05067270|144767061|OTHER||Geometric Least Squares Mean Ratio|1.49|||||TWO_SIDED|95.0|1.1|2.03||||||1 min post bolus (Bolus time: 9 hours)||2.03|1.10|
72617961|NCT05067270|144767061|OTHER||Geometric Least Squares Mean Ratio|1.96|||||TWO_SIDED|95.0|1.45|2.65||||||1 min post bolus (Bolus time: 9 hours)||2.65|1.45|
72617962|NCT05067270|144767061|OTHER||Geometric Least Squares Mean Ratio|2.03|||||TWO_SIDED|95.0|1.5|2.74||||||1 min post bolus (Bolus time: 9 hours)||2.74|1.50|
72617963|NCT05067270|144767061|OTHER||Geometric Least Squares Mean Ratio|1.25|||||TWO_SIDED|95.0|0.93|1.69||||||1 min post bolus (Bolus time: 9 hours)||1.69|0.93|
72617964|NCT05067270|144767061|OTHER||Geometric Least Squares Mean Ratio|1.31|||||TWO_SIDED|95.0|0.97|1.78||||||1 min post bolus (Bolus time: 9 hours)||1.78|0.97|
72617965|NCT05067270|144767061|OTHER||Geometric Least Squares Mean Ratio|1.36|||||TWO_SIDED|95.0|1.01|1.84||||||1 min post bolus (Bolus time: 9 hours)||1.84|1.01|
72617966|NCT05067270|144767061|OTHER||Geometric Least Squares Mean Ratio|0.84|||||TWO_SIDED|95.0|0.62|1.14||||||1 min post bolus (Bolus time: 9 hours)||1.14|0.62|
72617967|NCT05067270|144767061|OTHER||Geometric Least Squares Mean Ratio|1.04|||||TWO_SIDED|95.0|0.77|1.4||||||1 min post bolus (Bolus time: 9 hours)||1.40|0.77|
72617968|NCT05067270|144767061|OTHER||Geometric Least Squares Mean Ratio|0.64|||||TWO_SIDED|95.0|0.47|0.86||||||1 min post bolus (Bolus time: 9 hours)||0.86|0.47|
72617969|NCT05067270|144767061|OTHER||Geometric Least Squares Mean Ratio|0.62|||||TWO_SIDED|95.0|0.46|0.83||||||1 min post bolus (Bolus time: 9 hours)||0.83|0.46|
72617970|NCT06765889|144767070|OTHER||Bayes Factor (BF₁₀)|0.03|||||TWO_SIDED|||||||||||||
72617971|NCT06765889|144767073|OTHER||Mean (of both conditions)|4.17|||||TWO_SIDED|||||||||||||
72617972|NCT04193176|144767102|SUPERIORITY||Mean Difference (Net)|-11.67||||0.004|TWO_SIDED|95.0|-19.67|-3.67|||ANCOVA|||||-3.67|-19.67|0.004
72617973|NCT02370394|144767110|SUPERIORITY||Mean Difference (Final Values)|-4.14||||0.4016|TWO_SIDED|95.0|-14.02|5.75|||t-test, 2 sided|Unequal variances handled by Satterthwaite's degrees of freedom||CAS Victimization Total Score at Follow Up||5.75|-14.02|0.4016
72617974|NCT02370394|144767110|SUPERIORITY||Mean Difference (Net)|14.46||||0.0072|TWO_SIDED|95.0|4.11|24.82|||t-test, 2 sided|||Change in CAS Victimization Total score from Baseline to Follow Up||24.82|4.11|0.0072
72617975|NCT02370394|144767111|SUPERIORITY||Mean Difference (Final Values)|-0.04||||0.6011|TWO_SIDED|95.0|-0.21|0.12|||t-test, 2 sided|||Safety Behavior Change Score at Follow Up||0.12|-0.21|0.6011
72617976|NCT02370394|144767111|SUPERIORITY||Mean Difference (Net)|-0.01||||0.9116|TWO_SIDED|95.0|-0.16|0.15|||t-test, 2 sided|||Change is Safety Behavior Change Score from Baseline to Follow Up||0.15|-0.16|0.9116
72617977|NCT02370394|144767112|SUPERIORITY||Mean Difference (Final Values)|-0.13||||0.8646|TWO_SIDED|95.0|-1.62|1.36|||t-test, 2 sided|Unequal variances handled by Satterthwaite's degrees of freedom||EOR Number of issues Effective at Accomplishing at Follow Up||1.36|-1.62|0.8646
72617978|NCT02370394|144767112|SUPERIORITY||Mean Difference (Net)|-0.86||||0.3045|TWO_SIDED|95.0|-2.54|0.82|||t-test, 2 sided|||Change in Number of Issues Effective at Accomplishing from Baseline to Follow Up||0.82|-2.54|0.3045
72617979|NCT02370394|144767113|SUPERIORITY|||||||0.9085|||||||Wilcoxon (Mann-Whitney)|||Motivation Scale at Follow Up||||0.9085
72617980|NCT02370394|144767113|SUPERIORITY|||||||0.3256|||||||Wilcoxon (Mann-Whitney)|||Change in Motivation Scale from Baseline to Follow Up||||0.3256
72617981|NCT02370394|144767114|SUPERIORITY|||||||0.4085|||||||Wilcoxon (Mann-Whitney)|||Readiness at Follow Up||||0.4085
72617982|NCT02370394|144767114|SUPERIORITY|||||||0.2467|||||||Wilcoxon (Mann-Whitney)|||Change in Readiness from Baseline to Follow Up||||0.2467
72617983|NCT00908388|144767131|SUPERIORITY_OR_OTHER|||||||0.006||95.0||||(1-Posterior probability of meeting performance goal given the data)|Bayesian adaptive|||||||.006
72617984|NCT03566550|144767219|OTHER|||||||0.04|||||||Log Rank|||||||0.04
72617985|NCT03566550|144767220|OTHER|||||||0.3|||||||Wilcoxon (Mann-Whitney)|||||||0.3
72617986|NCT03566550|144767221|OTHER|||||||0.021|||||||Wilcoxon (Mann-Whitney)|||||||0.021
72617987|NCT03566550|144767222|OTHER|||||||0.012|||||||Wilcoxon (Mann-Whitney)|||||||0.012
72617988|NCT03566550|144767223|OTHER|||||||0.13|||||||Wilcoxon (Mann-Whitney)|||||||0.13
72617989|NCT02618187|144767227|OTHER|Null hypothesis: the two groups compared show no difference in mean ranks Alternative hypothesis: the two groups compared show a difference in mean ranks||||||0.766|||||||Wilcoxon (Mann-Whitney)|2-sided||||||0.766
72617990|NCT02618187|144767227|OTHER|Null hypothesis: the two groups compared show no difference in mean ranks Alternative hypothesis: the two groups compared show a difference in mean ranks||||||0.037|||||||Wilcoxon (Mann-Whitney)|2-sided||||||0.037
72617991|NCT02618187|144767227|OTHER|Null hypothesis: the two groups compared show no difference in mean ranks Alternative hypothesis: the two groups compared show a difference in mean ranks||||||0.313|||||||Wilcoxon (Mann-Whitney)|2-sided||||||0.313
72555105|NCT03086460|144641775|SUPERIORITY||Mean Difference (Final Values)|-0.001||||0.985|TWO_SIDED|95.0|-0.078|0.077|||ANCOVA|||"Day 14~Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.077|-0.078|0.985
72617992|NCT02618187|144767227|OTHER|Null hypothesis: the two groups compared show no difference in mean ranks Alternative hypothesis: the two groups compared show a difference in mean ranks||||||0.384|||||||Wilcoxon (Mann-Whitney)|2-sided||||||0.384
72617993|NCT02618187|144767227|OTHER|Null hypothesis: the two groups compared show no difference in mean ranks Alternative hypothesis: the two groups compared show a difference in mean ranks||||||0.237|||||||Wilcoxon (Mann-Whitney)|2-sided||||||0.237
72617994|NCT02618187|144767228|SUPERIORITY|Weekly SER-287, after Placebo Pre-Treat. tested against Daily placebo, after Placebo Pre-Treat., for superiority||||||0.257|||||||Wilcoxon (Mann-Whitney)|1-sided||||||0.257
72617995|NCT02618187|144767228|SUPERIORITY|Daily SER-287, After Vanco. Pre-Treat. tested against Daily Placebo, After Placebo Pre-Treat., for superiority||||||0.001|||||||Wilcoxon (Mann-Whitney)|1-sided||||||0.001
72617996|NCT02618187|144767228|SUPERIORITY|Weekly SER-287, After Vanco. Pre-Treat. tested against Daily Placebo, After Placebo Pre-Treat., for superiority||||||0.001|||||||Wilcoxon (Mann-Whitney)|1-sided||||||0.001
72617997|NCT02618187|144767228|SUPERIORITY|Weekly SER-287, After Vanco. Pre-Treat. tested against Weekly SER-287, After Placebo Pre-Treat., for superiority||||||0.009|||||||Wilcoxon (Mann-Whitney)|1-sided||||||0.009
72617998|NCT02618187|144767228|SUPERIORITY|Daily SER-287, After Vanco. Pre-Treat., tested against Weekly SER-287, After Vanco. Pre-Treat., for superiority||||||0.168|||||||Wilcoxon (Mann-Whitney)|1-sided||||||0.168
72617999|NCT02618187|144767229|SUPERIORITY||Rate difference (SER-287 - placebo)|13.3||||0.4923|TWO_SIDED|95.0|-3.87|30.54|||Fisher Exact|||||30.54|-3.87|0.4923
72618000|NCT02618187|144767229|SUPERIORITY||Rate difference (SER-287 - placebo)|40.0||||0.0237|TWO_SIDED|95.0|15.21|64.79|||Fisher Exact|||||64.79|15.21|0.0237
72618001|NCT02618187|144767229|SUPERIORITY||Rate difference (SER-287 - placebo)|17.6||||0.2579|TWO_SIDED|95.0|-0.47|35.77|||Fisher Exact|||||35.77|-0.47|0.2579
72618002|NCT02618187|144767230|SUPERIORITY||Rate difference (SER-287 - placebo)|24.2||||0.1973|TWO_SIDED|95.0|-5.04|53.53|||Fisher Exact|||||53.53|-5.04|0.1973
72618003|NCT02618187|144767230|SUPERIORITY||Rate difference (SER-287 - placebo)|30.9||||0.1783|TWO_SIDED|95.0|0.86|60.96|||Fisher Exact|||||60.96|0.86|0.1783
72618004|NCT02618187|144767230|SUPERIORITY||Rate difference (SER-287 - placebo)|14.4||||0.6195|TWO_SIDED|95.0|-11.93|40.81|||Fisher Exact|||||40.81|-11.93|0.6195
72618005|NCT03518203|144767270|EQUIVALENCE|A binomial test was used to test 6 month survival in study cohort against an 18% historical rate.|Proportion|0.714|||<|0.0001|TWO_SIDED|||||The a priori threshold was 0.05.|binomial test|||||||<0.0001
72618006|NCT04560309|144767286|SUPERIORITY|||||||0.993||||||The threshold for statistical significance was p \< 0.05|Wilcoxon (Mann-Whitney)|||||||0.993
72618007|NCT04560309|144767287|SUPERIORITY|||||||0.883||||||The threshold for statistical significance was p \< 0.05|Unpaired T-Test|||||||0.883
72618008|NCT04560309|144767288|SUPERIORITY|||||||0.034||||||The threshold for statistical significance was p \< 0.05|Unpaired T-Test|||||||0.034
72618009|NCT04560309|144767289|SUPERIORITY|||||||0.038||||||The threshold for statistical significance was p \< 0.05|Wilcoxon (Mann-Whitney)|||||||0.038
72618010|NCT04560309|144767290|SUPERIORITY|||||||0.423||||||The threshold for statistical significance was p \< 0.05|Wilcoxon (Mann-Whitney)|||||||0.423
72618011|NCT04560309|144767291|SUPERIORITY|||||||0.216||||||The threshold for statistical significance was p \< 0.05|Unpaired T-Test|||||||0.216
72618012|NCT04560309|144767292|SUPERIORITY|||||||0.001||||||The threshold for statistical significance was p \< 0.05|Unpaired T-Test|||||||0.001
72618013|NCT04560309|144767293|SUPERIORITY|||||||0.043||||||The threshold for statistical significance was p \< 0.05|Unpaired T-Test|||||||0.043
72618014|NCT04560309|144767294|SUPERIORITY|||||||0.011||||||The threshold for statistical significance was p \< 0.05|Unpaired T-Test|||||||0.011
72618015|NCT04560309|144767295|SUPERIORITY|||||||0.975||||||The threshold for statistical significance was p \< 0.05|Wilcoxon (Mann-Whitney)|||||||0.975
72618016|NCT04560309|144767296|SUPERIORITY|||||||0.031||||||The threshold for statistical significance was p \< 0.05|Wilcoxon (Mann-Whitney)|||||||0.031
72618017|NCT04560309|144767297|SUPERIORITY|||||||0.549||||||The threshold of statistical significance was p \< 0.05|Wilcoxon (Mann-Whitney)|||||||0.549
72618018|NCT04560309|144767298|SUPERIORITY|||||||0.645||||||The threshold of statistical significance was p \< 0.05|Unpaired T-Test|||||||0.645
72618019|NCT04560309|144767299|SUPERIORITY|||||||0.33||||||The threshold of statistical significance was p \< 0.05|Unpaired T-Test|||After induction to anesthesia||||0.330
72618020|NCT04560309|144767299|SUPERIORITY|||||||0.352||||||The threshold of statistical significance was p \< 0.05|Unpaired T-Test|||5 minutes after cardiopulmonary bypass||||0.352
72618021|NCT04560309|144767299|SUPERIORITY|||||||0.544||||||The threshold of statistical significance was p \< 0.05|Unpaired T-Test|||2 hours after cardiopulmonary bypass||||0.544
72618022|NCT04560309|144767299|SUPERIORITY|||||||0.022||||||The threshold of statistical significance was p \< 0.05|Unpaired T-Test|||6 hours after cardiopulmonary bypass||||0.022
72618023|NCT04560309|144767299|SUPERIORITY|||||||0.038||||||The threshold of statistical significance was p \< 0.05|Unpaired T-Test|||24 hour after cardiopulmonary bypass||||0.038
72618024|NCT04560309|144767300|SUPERIORITY|||||||0.2||||||The threshold of statistical significance was p \< 0.05|Wilcoxon (Mann-Whitney)|||||||0.200
72618025|NCT04560309|144767301|SUPERIORITY|||||||0.72||||||The threshold of statistical significance was p \< 0.05|Unpaired T-Test|||||||0.720
72618026|NCT04560309|144767302|SUPERIORITY|||||||0.042||||||The threshold of statistical significance was p \< 0.05|Wilcoxon (Mann-Whitney)|||||||0.042
72618027|NCT04560309|144767303|SUPERIORITY|||||||0.044||||||The threshold of statistical significance was p \< 0.05|Unpaired T-Test|||||||0.044
72618028|NCT04560309|144767304|SUPERIORITY|||||||0.349||||||The threshold of statistical significance was p \< 0.05|Unpaired T-Test|||||||0.349
72371758|NCT00669409|144253476|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-16.7|STANDARD_ERROR_OF_MEAN|8.34|||TWO_SIDED|95.0|-33.2|-0.3||||||Change at Week 1, Stiffness: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-0.3|-33.2|
72371759|NCT00669409|144253476|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-27.2|STANDARD_ERROR_OF_MEAN|8.34|||TWO_SIDED|95.0|-43.7|-10.8||||||Change at Week 1, Stiffness: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-10.8|-43.7|
72432394|NCT02696785|144377183|SUPERIORITY||LSMean Difference|-1.9|STANDARD_ERROR_OF_MEAN|0.73||0.011|TWO_SIDED|95.0|-3.4|-0.4|||Mixed Models Analysis|||||-0.4|-3.4|0.011
72555106|NCT03086460|144641775|SUPERIORITY||Mean Difference (Final Values)|0.066||||0.084|TWO_SIDED|95.0|-0.009|0.14|||ANCOVA|||"Day 14~Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.140|-0.009|0.084
72618029|NCT04560309|144767305|SUPERIORITY|||||||0.95||||||The threshold of statistical significance was p \< 0.05|Unpaired T-Test|||||||0.950
72618030|NCT04560309|144767306|SUPERIORITY|The threshold of statistical significance was p \< 0.05||||||0.862|||||||Wilcoxon (Mann-Whitney)|||||||0.862
72618031|NCT04560309|144767307|SUPERIORITY|The threshold of statistical significance was p \< 0.05||||||0.075|||||||Wilcoxon (Mann-Whitney)|||||||0.075
72618032|NCT02362412|144767325|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.5|||||TWO_SIDED|95.0|-3.4|2.3||p-value was not adjusted|||Analysis of variance with treatment sequence, time point, and formulation as fixed effects and patient as a random effect using the data at Week 12 and Week 20 of the treatment period.|||2.3|-3.4|
72618033|NCT02362412|144767326|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|0.1|||||TWO_SIDED|95.0|-1.7|1.9|||||Analysis of variance with treatment sequence, time point, and formulation as fixed effects and patient as a random effect using the data at Week 12 and Week 20 of the treatment period.|||1.9|-1.7|
72618034|NCT02362412|144767327|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|0.1|||||TWO_SIDED|95.0|-0.3|0.4|||||Analysis of variance with treatment sequence, time point, and formulation as fixed effects and patient as a random effect using the data at Week 12 and Week 20 of the treatment period.|||0.4|-0.3|
72618035|NCT02362412|144767328|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|0.1|||||TWO_SIDED|95.0|-0.3|0.4|||||Analysis of variance with treatment sequence, time point, and formulation as fixed effects and patient as a random effect using the data at Week 12 and Week 20 of the treatment period.|||0.4|-0.3|
72618036|NCT02362412|144767330|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|0.0|||||TWO_SIDED|95.0|-0.5|0.5|||||Analysis of variance with treatment sequence, time point, and formulation as fixed effects and patient as a random effect using the data at Week 12 and Week 20 of the treatment period.|||0.5|-0.5|
72618037|NCT02362412|144767331|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|0.0|||||TWO_SIDED|95.0|-0.5|0.5|||||Analysis of variance with treatment sequence, time point, and formulation as fixed effects and patient as a random effect using the data at Week 12 and Week 20 of the treatment period.|||0.5|-0.5|
72618038|NCT05103332|144767342|SUPERIORITY||Difference in LS Mean|-12.1|STANDARD_ERROR_OF_MEAN|2.24|<|0.0001|TWO_SIDED|95.0|-16.5|-7.6||MMRM: Fixed factors: treatment, visit, treatment-by-visit interaction, race (black/all other races); Covariates: Baseline (BA) 24-hour mean SBP using ABPM \& BA estimated glomerular filtration rate (eGFR). Unstructured covariance matrix was used.|MMRM||LS Mean Difference between zilebesiran (add on to indapamide) and placebo (add on to indapamide), 95% CI was calculated using MMRM model.|A hierarchical testing procedure was used to control type I error at α=0.05 within each cohort \& handle primary \& key secondary endpoints analyses. Testing was then performed sequentially in order the endpoints are reported. Hierarchical testing sequence continued only when previous endpoint was statistically significant at nominal p-value \< 0.05. Data for SBP, assessed using ABPM, while participants were on \& within 2 weeks after stopping any escape medication were censored for this endpoint.||-7.6|-16.5|<0.0001
72618039|NCT05103332|144767343|SUPERIORITY||Difference in LS Mean|-9.7|STANDARD_ERROR_OF_MEAN|1.61|<|0.0001|TWO_SIDED|95.0|-12.9|-6.6||MMRM model included treatment, visit, treatment-by-visit interaction, race (black or all other races) as fixed factors, with baseline 24-hour mean SBP assessed by ABPM and baseline eGFR as covariates. Unstructured covariance matrix was used.|MMRM||LS Mean Difference between zilebesiran (add on to amlodipine) and placebo (add on to amlodipine), 95% CI was calculated using MMRM model.|A hierarchical testing procedure was used to control type I error at α=0.05 within each cohort \& handle primary \& key secondary endpoints analyses. Testing was then performed sequentially in order the endpoints are reported. Hierarchical testing sequence continued only when previous endpoint was statistically significant at nominal p-value \< 0.05. Data for SBP, assessed using ABPM, while participants were on \& within 2 weeks after stopping any escape medication were censored for this endpoint.||-6.6|-12.9|<0.0001
72618040|NCT05103332|144767344|SUPERIORITY||Difference in LS Mean|-4.5|STANDARD_ERROR_OF_MEAN|1.89|=|0.0183|TWO_SIDED|95.0|-8.2|-0.8||MMRM model included treatment, visit, treatment-by-visit interaction, race (black or all other races) as fixed factors, with baseline 24-hour mean SBP assessed by ABPM and baseline eGFR as covariates. Unstructured covariance matrix was used.|MMRM||LS Mean Difference between zilebesiran (add on to olmesartan) and placebo (add on to olmesartan), 95% CI was calculated using MMRM model.|A hierarchical testing procedure was used to control type I error at α=0.05 within each cohort \& handle primary \& key secondary endpoints analyses. Testing was then performed sequentially in order the endpoints are reported. Hierarchical testing sequence continued only when previous endpoint was statistically significant at nominal p-value \< 0.05. Data for SBP, assessed using ABPM, while participants were on \& within 2 weeks after stopping any escape medication were censored for this endpoint.||-0.8|-8.2|=0.0183
72618041|NCT05103332|144767345|SUPERIORITY||Difference in LS Mean|-18.5|STANDARD_ERROR_OF_MEAN|2.17|<|0.0001|TWO_SIDED|95.0|-22.8|-14.2||MMRM model included treatment, visit, treatment-by-visit interaction, race (black or all other races) as fixed factors, with baseline office SBP and baseline eGFR as covariates. Unstructured covariance matrix was used.|MMRM||LS Mean Difference between zilebesiran (add on to indapamide) and placebo (add on to indapamide), 95% CI was calculated using MMRM model.|A hierarchical testing procedure was used to control type I error at α=0.05 within each cohort and handle primary and key secondary endpoints analyses. Testing was then performed sequentially in order the endpoints are reported. Hierarchical testing sequence continued only when previous endpoint was statistically significant at nominal p-value \< 0.05. Data for office SBP assessed while participants were on and within 2 weeks after stopping any escape medication were censored for this endpoint.||-14.2|-22.8|<0.0001
72618042|NCT05103332|144767346|SUPERIORITY||Difference in LS Mean|-11.0|STANDARD_ERROR_OF_MEAN|1.88|<|0.0001|TWO_SIDED|95.0|-14.7|-7.3||MMRM model included treatment, visit, treatment-by-visit interaction, race (black or all other races) as fixed factors, with baseline 24-hour mean SBP assessed by ABPM and baseline eGFR as covariates. Unstructured covariance matrix was used.|MMRM||LS Mean Difference between zilebesiran (add on to indapamide) and placebo (add on to indapamide), 95% CI was calculated using MMRM model.|A hierarchical testing procedure was used to control type I error at α=0.05 within each cohort and handle primary and key secondary endpoints analyses. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at nominal p-value \< 0.05. All collected data for SBP assessed by ABPM, were included in the analysis for this endpoint.||-7.3|-14.7|<0.0001
72618043|NCT05103332|144767347|SUPERIORITY||Difference in LS Mean|-13.6|STANDARD_ERROR_OF_MEAN|1.66|<|0.0001|TWO_SIDED|95.0|-16.9|-10.3||MMRM model included treatment, visit, treatment-by-visit interaction, race (black or all other races) as fixed factors, with baseline office SBP and baseline eGFR as covariates. Unstructured covariance matrix was used.|MMRM||LS Mean Difference between zilebesiran (add on to indapamide) and placebo (add on to indapamide), 95% CI was calculated using MMRM model.|A hierarchical testing procedure was used to control type I error at α=0.05 within each cohort and handle primary and key secondary endpoints analyses. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at nominal p-value \< 0.05. All collected data for office SBP were included in the analysis for this endpoint.||-10.3|-16.9|<0.0001
72618044|NCT05103332|144767348|SUPERIORITY||Odds Ratio (OR)|12.39|||<|0.0001|TWO_SIDED|95.0|4.61|33.29||Logistic regression model included treatment and race (black or all other races) as factors and baseline 24-hour mean SBP and baseline eGFR as covariates.|Regression, Logistic|||A hierarchical testing procedure was used to control type I error at α=0.05 within each cohort and handle primary and key secondary endpoints analyses. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at nominal p-value \< 0.05.||33.29|4.61|<0.0001
72618045|NCT05103332|144767359|SUPERIORITY||Difference in LS Mean|-10.2|STANDARD_ERROR_OF_MEAN|1.67|<|0.0001|TWO_SIDED|95.0|-13.4|-6.9||MMRM model included treatment, visit, treatment-by-visit interaction, race (black or all other races) as fixed factors, with baseline office SBP and baseline eGFR as covariates. Unstructured covariance matrix was used.|MMRM||LS Mean Difference between zilebesiran (add on to amlodipine) and placebo (add on to amlodipine), 95% CI was calculated using MMRM model.|A hierarchical testing procedure was used to control type I error at α=0.05 within each cohort and handle primary and key secondary endpoints analyses. Testing was then performed sequentially in order the endpoints are reported. Hierarchical testing sequence continued only when previous endpoint was statistically significant at nominal p-value \< 0.05. Data for office SBP assessed while participants were on and within 2 weeks after stopping any escape medication were censored for this endpoint.||-6.9|-13.4|<0.0001
72618046|NCT05103332|144767360|SUPERIORITY||Difference in LS Mean|-7.9|STANDARD_ERROR_OF_MEAN|1.36|<|0.0001|TWO_SIDED|95.0|-10.6|-5.3||MMRM model included treatment, visit, treatment-by-visit interaction, race (black or all other races) as fixed factors, with baseline 24-hour mean SBP assessed by ABPM and baseline eGFR as covariates. Unstructured covariance matrix was used.|MMRM||LS Mean Difference between zilebesiran (add on to amlodipine) and placebo (add on to amlodipine), 95% CI was calculated using MMRM model.|A hierarchical testing procedure was used to control type I error at α=0.05 within each cohort and handle primary and key secondary endpoints analyses. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at nominal p-value \< 0.05. All collected data for SBP assessed by ABPM, were included in the analysis for this endpoint.||-5.3|-10.6|<0.0001
72618047|NCT05103332|144767361|SUPERIORITY||Difference in LS Mean|-8.6|STANDARD_ERROR_OF_MEAN|1.16|<|0.0001|TWO_SIDED|95.0|-10.9|-6.3||MMRM model included treatment, visit, treatment-by-visit interaction, race (black or all other races) as fixed factors, with baseline office SBP and baseline eGFR as covariates. Unstructured covariance matrix was used.|MMRM||LS Mean Difference between zilebesiran (add on to amlodipine) and placebo (add on to amlodipine), 95% CI was calculated using MMRM model.|A hierarchical testing procedure was used to control type I error at α=0.05 within each cohort and handle primary and key secondary endpoints analyses. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at nominal p-value \< 0.05. All collected data for office SBP were included in the analysis for this endpoint.||-6.3|-10.9|<0.0001
72618048|NCT05103332|144767362|SUPERIORITY||Odds Ratio (OR)|5.08|||<|0.0001|TWO_SIDED|95.0|2.43|10.61||Logistic regression model included treatment and race (black or all other races) as factors and baseline 24-hour mean SBP and baseline eGFR as covariates.|Regression, Logistic|||A hierarchical testing procedure was used to control type I error at α=0.05 within each cohort and handle primary and key secondary endpoints analyses. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at nominal p-value \< 0.05.||10.61|2.43|<0.0001
72618049|NCT05103332|144767373|SUPERIORITY||Difference in LS Mean|-6.7|STANDARD_ERROR_OF_MEAN|1.76|=|0.0002|TWO_SIDED|95.0|-10.2|-3.3||MMRM model included treatment, visit, treatment-by-visit interaction, race (black or all other races) as fixed factors, with baseline office SBP and baseline eGFR as covariates. Unstructured covariance matrix was used.|MMRM||LS Mean Difference between zilebesiran (add on to olmesartan) and placebo (add on to olmesartan), 95% CI was calculated using MMRM model.|A hierarchical testing procedure was used to control type I error at α=0.05 within each cohort and handle primary and key secondary endpoints analyses. Testing was then performed sequentially in order the endpoints are reported. Hierarchical testing sequence continued only when previous endpoint was statistically significant at nominal p-value \< 0.05. Data for office SBP assessed while participants were on and within 2 weeks after stopping any escape medication were censored for this endpoint.||-3.3|-10.2|=0.0002
72618050|NCT05103332|144767374|SUPERIORITY||Difference in LS Mean|-1.8|STANDARD_ERROR_OF_MEAN|1.42|=|0.2103|TWO_SIDED|95.0|-4.6|1.0||MMRM model included treatment, visit, treatment-by-visit interaction, race (black or all other races) as fixed factors, with baseline 24-hour mean SBP assessed by ABPM and baseline eGFR as covariates. Unstructured covariance matrix was used.|MMRM||LS Mean Difference between zilebesiran (add on to olmesartan) and placebo (add on to olmesartan), 95% CI was calculated using MMRM model.|A hierarchical testing procedure was used to control type I error at α=0.05 within each cohort and handle primary and key secondary endpoints analyses. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at nominal p-value \< 0.05. All collected data for SBP assessed by ABPM, were included in the analysis for this endpoint.||1.0|-4.6|=0.2103
72618051|NCT05103332|144767375|SUPERIORITY||Difference in LS Mean|-4.5|STANDARD_ERROR_OF_MEAN|1.14|<|0.0001|TWO_SIDED|95.0|-6.8|-2.3||MMRM model included treatment, visit, treatment-by-visit interaction, race (black or all other races) as fixed factors, with baseline office SBP and baseline eGFR as covariates. Unstructured covariance matrix was used.|MMRM||LS Mean Difference between zilebesiran (add on to olmesartan) and placebo (add on to olmesartan), 95% CI was calculated using MMRM model.|A hierarchical testing procedure was used to control type I error at α=0.05 within each cohort and handle primary and key secondary endpoints analyses. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at nominal p-value \< 0.05. All collected data for office SBP were included in the analysis for this endpoint.||-2.3|-6.8|<0.0001
72618052|NCT05103332|144767376|SUPERIORITY||Odds Ratio (OR)|1.67|||=|0.123|TWO_SIDED|95.0|0.87|3.23||Logistic regression model included treatment and race (black or all other races) as factors and baseline 24-hour mean SBP and baseline eGFR as covariates.|Regression, Logistic|||A hierarchical testing procedure was used to control type I error at α=0.05 within each cohort and handle primary and key secondary endpoints analyses. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at nominal p-value \< 0.05.||3.23|0.87|=0.1230
72618053|NCT04906421|144767393|SUPERIORITY|||||||0.0018||||||Stratified CMH test stratified by T2DM status at baseline (yes or no) and amount of fibrosis at baseline (F2 or F3).|Cochran-Mantel-Haenszel|One-sided||ITT Population analysis||||0.0018
72618054|NCT04906421|144767393|SUPERIORITY|||||||0.0035||||||Stratified CMH test stratified by T2DM status at baseline (yes or no) and amount of fibrosis at baseline (F2 or F3).|Cochran-Mantel-Haenszel|Two-sided||ITT Population Analysis||||0.0035
72555107|NCT03086460|144641775|SUPERIORITY||Mean Difference (Final Values)|0.004||||0.928|TWO_SIDED|95.0|-0.078|0.086|||ANCOVA|||"Day 14~Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment B (CHF 1531 pMDI 12 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.086|-0.078|0.928
72618055|NCT04906421|144767393|SUPERIORITY|||||||0.0001||||||Stratified CMH test stratified by T2DM status at baseline (yes or no) and amount of fibrosis at baseline (F2 or F3).|t-test, 1 sided|One-sided||mITT Population Analysis||||0.0001
72555108|NCT03086460|144641775|SUPERIORITY||Mean Difference (Final Values)|0.07||||0.078|TWO_SIDED|95.0|-0.008|0.148|||ANCOVA|||"Day 14~Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment B (CHF 1531 pMDI 12 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.148|-0.008|0.078
72555109|NCT03086460|144641775|SUPERIORITY||Mean Difference (Final Values)|0.066||||0.089|TWO_SIDED|95.0|-0.01|0.143|||ANCOVA|||"Day 14~Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment C (CHF 1531 pMDI 24 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.143|-0.010|0.089
72371760|NCT00669409|144253476|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-6.8|STANDARD_ERROR_OF_MEAN|8.45|||TWO_SIDED|95.0|-23.4|9.9||||||Change at Week 1, Stiffness: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||9.9|-23.4|
72618056|NCT04906421|144767393|SUPERIORITY|||||||0.0003||||||Stratified CMH test stratified by T2DM status at baseline (yes or no) and amount of fibrosis at baseline (F2 or F3).|Cochran-Mantel-Haenszel|Two-sided||mITT Population Analysis||||0.0003
72618057|NCT04906421|144767394|SUPERIORITY|||||||0.0087||||||Stratified CMH test stratified by T2DM status at baseline (yes or no) and amount of fibrosis at baseline (F2 or F3).|Cochran-Mantel-Haenszel|One-sided||ITT Population Analysis||||0.0087
72618058|NCT04906421|144767394|SUPERIORITY|||||||0.0173||||||Stratified CMH test stratified by T2DM status at baseline (yes or no) and amount of fibrosis at baseline (F2 or F3).|Cochran-Mantel-Haenszel|Two-sided||ITT Population Analysis||||0.0173
72618059|NCT04906421|144767394|SUPERIORITY|||||||0.0022||||||Stratified CMH test stratified by T2DM status at baseline (yes or no) and amount of fibrosis at baseline (F2 or F3).|Cochran-Mantel-Haenszel|One-sided||mITT Population Analysis||||0.0022
72618060|NCT04906421|144767394|SUPERIORITY|||||||0.0044||||||Stratified CMH test stratified by T2DM status at baseline (yes or no) and amount of fibrosis at baseline (F2 or F3).|Cochran-Mantel-Haenszel|Two-sided||mITT Population Analysis||||0.0044
72618061|NCT04906421|144767395|SUPERIORITY|||||||0.0102|TWO_SIDED|95.0||||Stratified CMH test stratified by T2DM status at baseline (yes or no) and amount of fibrosis at baseline (F2 or F3).|Cochran-Mantel-Haenszel|Two-sided||mITT Population Analysis||||0.0102
72618062|NCT04906421|144767395|SUPERIORITY|||||||0.59|TWO_SIDED|95.0||||Stratified CMH test stratified by T2DM status at baseline (yes or no) and amount of fibrosis at baseline (F2 or F3).|Cochran-Mantel-Haenszel|Two-sided||Subgroup Fibrosis Stage F2 at Baseline Population Analysis||||0.59
72618063|NCT04906421|144767395|SUPERIORITY|||||||0.0032|TWO_SIDED|95.0||||Stratified CMH test stratified by T2DM status at baseline (yes or no) and amount of fibrosis at baseline (F2 or F3).|Cochran-Mantel-Haenszel|Two-Sided||Subgroup Fibrosis Stage F3 at Baseline Population Analysis||||0.0032
72618064|NCT04906421|144767395|SUPERIORITY|||||||0.0764|TWO_SIDED|95.0||||Stratified CMH test stratified by T2DM status at baseline (yes or no) and amount of fibrosis at baseline (F2 or F3).|Cochran-Mantel-Haenszel|Two-sided||Subgroup Type 2 Diabetes Mellitus at Baseline Population Analysis||||0.0764
72618065|NCT04906421|144767396|SUPERIORITY|||||||0.0043||||||Stratified CMH test stratified by T2DM status at baseline (yes or no) and amount of fibrosis at baseline (F2 or F3).|Cochran-Mantel-Haenszel|Two-sided||mITT Population Analysis||||0.0043
72618066|NCT04906421|144767397|SUPERIORITY|||||||0.0018||||||Stratified CMH test stratified by T2DM status at baseline (yes or no) and amount of fibrosis at baseline (F2 or F3).|Cochran-Mantel-Haenszel|Two-sided||mITT Population Analysis||||0.0018
72618067|NCT04906421|144767398|SUPERIORITY||||||<|0.0001||||||Stratified CMH test stratified by T2DM status at baseline (yes or no) and amount of fibrosis at baseline (F2 or F3).|Cochran-Mantel-Haenszel|Two-sided||mITT Population Analysis||||<0.0001
72618068|NCT01125748|144767399|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|19.3|||||TWO_SIDED|95.0|5.0|33.6||||||||33.6|5.0|
72618069|NCT02405962|144767401|SUPERIORITY||Adjusted Incidence Rate Ratio|0.2|||<|0.05|TWO_SIDED|95.0|0.08|0.53|||Mixed Models Analysis|||||0.53|0.08|<0.05
72618070|NCT01028391|144767416|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.51|STANDARD_ERROR_OF_MEAN|4.0||||95.0|-0.76|-0.26|||||This is a difference in least squares means, based on an ANCOVA model with terms for treatment and baseline (i.e., Week 0 of the 24-week base study) HbA1c.|||-0.26|-0.76|
72618071|NCT01028391|144767417|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-8.5|STANDARD_ERROR_OF_MEAN|4.0||||95.0|-16.3|-0.7|||||This is a difference in least squares means, based on an ANCOVA model with terms for treatment and baseline (i.e., Week 0 of the 24-week base study) FPG.|||-0.7|-16.3|
72618072|NCT01227395|144767420|SUPERIORITY_OR_OTHER||||||=|0.696|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Age. The null hypothesis is there is no difference between \<65 years and \>=65 years  in the frequency of Treatment Related Adverse Events(TRAEs)."||||=0.696
72618073|NCT01227395|144767421|SUPERIORITY_OR_OTHER||||||=|0.334|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Gender. The null hypothesis is there is no difference between Male and Female  in the frequency of Treatment Related Adverse Events(TRAEs)."||||=0.334
72618074|NCT01227395|144767422|SUPERIORITY_OR_OTHER||||||=|1|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was concomitant drugs. The null hypothesis is there is no difference between with and without concomitant drugs  in the frequency of Treatment Related Adverse Events(TRAEs)."||||=1.000
72618075|NCT01227395|144767423|SUPERIORITY_OR_OTHER||||||=|1|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Renal Dysfunction. The null hypothesis is there is no difference between with and without renal dysfunction  in the frequency of Treatment Related Adverse Events(TRAEs)."||||=1.000
72618076|NCT01227395|144767424|SUPERIORITY_OR_OTHER||||||=|0.015|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Allergies. The null hypothesis is there is no difference between with and without allergies in the frequency of Treatment Related Adverse Events(TRAEs)."||||=0.015
72618077|NCT01227395|144767425|SUPERIORITY_OR_OTHER||||||=|1|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Age. The null hypothesis is there is no difference between \<65 years and \>=65 years  in the frequency of Treatment Related Adverse Events(TRAEs)."||||=1.000
72618078|NCT01227395|144767426|SUPERIORITY_OR_OTHER||||||=|0.29|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Gender. The null hypothesis is there is no difference between Male and Female  in the frequency of Treatment Related Adverse Events(TRAEs)."||||=0.290
72618079|NCT01227395|144767427|SUPERIORITY_OR_OTHER||||||=|0.003|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Renal Dysfunction. The null hypothesis is there is no difference between with and without renal dysfunction  in the frequency of Treatment Related Adverse Events(TRAEs)."||||=0.003
72618080|NCT01227395|144767428|SUPERIORITY_OR_OTHER||||||=|0.707|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Allergies. The null hypothesis is there is no difference between with and without allergies in the frequency of Treatment Related Adverse Events(TRAEs)."||||=0.707
72618081|NCT01398475|144767431|SUPERIORITY_OR_OTHER||Geometric least squares (LS) mean ratio|1.02|||||TWO_SIDED|90.0|0.951|1.1|||||The geometric LS mean ratio (TF1 fasted divided by RF fasted) was calculated using a linear mixed-effects model adjusted for treatment, sequence, period, and participant.|||1.10|0.951|
72618082|NCT01398475|144767431|SUPERIORITY_OR_OTHER||Geometric LS mean ratio|1.02|||||TWO_SIDED|90.0|0.947|1.09|||||The geometric LS mean ratio (TF2 fasted divided by RF fasted) was calculated using a linear mixed-effects model adjusted for treatment, sequence, period, and participant.|||1.09|0.947|
72618083|NCT01398475|144767431|SUPERIORITY_OR_OTHER||Geometric LS mean ratio|0.888|||||TWO_SIDED|90.0|0.827|0.953|||||The geometric LS mean ratio (TF2 fed divided by TF2 fasted) was calculated using a linear mixed-effects model adjusted for treatment, sequence, period, and participant.|||0.953|0.827|
72618084|NCT01398475|144767432|SUPERIORITY_OR_OTHER||Geometric least squares (LS) mean ratio|0.979|||||TWO_SIDED|90.0|0.868|1.1|||||The geometric LS mean ratio (TF1 fasted divided by RF fasted) was calculated using a linear mixed-effects model adjusted for treatment, sequence, period, and participant.|||1.10|0.868|
72618085|NCT01398475|144767432|SUPERIORITY_OR_OTHER||Geometric LS mean ratio|0.962|||||TWO_SIDED|90.0|0.852|1.08|||||The geometric LS mean ratio (TF2 fasted divided by RF fasted) was calculated using a linear mixed-effects model adjusted for treatment, sequence, period, and participant.|||1.08|0.852|
72618086|NCT01398475|144767432|SUPERIORITY_OR_OTHER||Geometric LS mean ratio|0.82|||||TWO_SIDED|90.0|0.727|0.925|||||The geometric LS mean ratio (TF2 fed divided by TF2 fasted) was calculated using a linear mixed-effects model adjusted for treatment, sequence, period, and participant.|||0.925|0.727|
72618087|NCT01398475|144767433|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.719|TWO_SIDED|90.0|-0.25|0.5|||Wilcoxon (Mann-Whitney)||The median difference was calculated as TF1 fasted minus RF fasted.|||0.500|-0.250|0.719
72618088|NCT01398475|144767433|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.96|TWO_SIDED|90.0|-0.25|0.75|||Wilcoxon (Mann-Whitney)||The median difference was calculated as TF2 fasted minus RF fasted.|||0.750|-0.250|0.960
72618089|NCT01398475|144767433|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.5||||0.006|TWO_SIDED|90.0|0.0|2.0|||Wilcoxon (Mann-Whitney)||The median difference was calculated as TF2 fed minus TF2 fasted.|||2.00|0|0.006
72618090|NCT00086307|144767438|SUPERIORITY_OR_OTHER||Mean Difference (Net)|6.826|STANDARD_ERROR_OF_MEAN|2.296||0.018|TWO_SIDED|95.0|1.111|12.541||This is the omnibus effect of drug.|Mixed Models Analysis|||A linear mixed model with restricted maximum likelihood estimation and a first order autoregressive covariance structure was used to examine depressive symptoms over time. Fixed factors for drug, time, and a time by drug interaction were included in the model along with the intercept. No random factors were included because the subject factor did not contribute significantly to the model. Baseline symptoms were used as a covariate.||12.541|1.111|.018
72618091|NCT00086307|144767438|SUPERIORITY_OR_OTHER||Mean Difference (Net)|6.826|STANDARD_ERROR_OF_MEAN|2.296||0.014|TWO_SIDED|95.0|1.111|12.541||The significance level was adjusted using a Bonferroni correction.|Post hoc simple effects test||The pramipexole group had a lower MADRS score than the pramipexole and escitalopram group.|Post-hoc simple effects tests with Bonferroni correction were used to compare the pramipexole group to the pramipexole and escitalopram combination group.||12.541|1.111|.014
72618092|NCT00086307|144767438|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.353|STANDARD_ERROR_OF_MEAN|2.296||0.454|TWO_SIDED|95.0|-2.36|9.066||The significance level was adjusted using a Bonferroni correction.|Post hoc simple effects test||The escitalopram group had a lower MADRS score than the pramipexole and escitalopram group.|Post-hoc simple effects tests with Bonferroni correction were used to compare the escitalopram group to the pramipexole and escitalopram combination group.||9.066|-2.360|.454
72618093|NCT00086307|144767438|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.473|STANDARD_ERROR_OF_MEAN|2.162||0.349|TWO_SIDED|95.0|-1.942|8.888||The significance level was adjusted using a Bonferroni correction.|Post hoc simple effects test||The pramipexole group had a lower MADRS score than the escitalopram group.|Post-hoc simple effects tests with Bonferroni correction were used to compare the pramipexole group to the escitalopram group.||8.888|-1.942|.349
72618094|NCT03632720|144767465|NON_INFERIORITY|The overall non-inferiority was demonstrated if the lower limit of the 2-sided 95 percent (%) confidence interval (CI) was greater (\>) -10% for all four serogroups.|Difference in Percentage|0.64|||||TWO_SIDED|95.0|-1.78|3.54||||||Serogroup A||3.54|-1.78|
72618095|NCT03632720|144767465|NON_INFERIORITY|The overall non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI was \> -10% for all four serogroups.|Difference in Percentage|0.0|||||TWO_SIDED|95.0|-2.24|2.28||||||Serogroup C||2.28|-2.24|
72618096|NCT03632720|144767465|NON_INFERIORITY|The overall non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI was \> -10% for all four serogroups.|Difference in Percentage|0.0|||||TWO_SIDED|95.0|-2.33|2.36||||||Serogroup Y||2.36|-2.33|
72618097|NCT03632720|144767465|NON_INFERIORITY|The overall non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI was \> -10% for all four serogroups.|Difference in Percentage|-0.58|||||TWO_SIDED|95.0|-3.22|1.81||||||Serogroup W||1.81|-3.22|
72555110|NCT03086460|144641776|SUPERIORITY||Hazard Ratio (HR)|18.01|||<|0.001|TWO_SIDED|95.0|4.25|76.37|||Regression, Cox|||"Day 1~Comparison groups were:~Treatment A (CHF 1531 pMDI 6 μg TDD) versus Treatment E (Placebo).~Time to onset of action was analyzed using a Cox proportional hazard model stratified by patient, including treatment and period as a factor, and baseline FEV1 as covariate.~For patients receiving the same treatment twice, the analysis includes only data from the first instance of each treatment."||76.37|4.25|<0.001
72555111|NCT03086460|144641776|SUPERIORITY||Hazard Ratio (HR)|31.67|||<|0.001|TWO_SIDED|95.0|7.52|133.47|||Regression, Cox|||"Day 1~Comparison groups were:~Treatment B (CHF 1531 pMDI 12 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||133.47|7.52|<0.001
72555112|NCT03086460|144641776|SUPERIORITY||Hazard Ratio (HR)|44.24|||<|0.001|TWO_SIDED|95.0|10.23|191.34|||Regression, Cox|||"Day 1~Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||191.34|10.23|<0.001
72555113|NCT03086460|144641776|SUPERIORITY||Hazard Ratio (HR)|40.32|||<|0.001|TWO_SIDED|95.0|9.54|170.45|||Regression, Cox|||"Day 1~Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||170.45|9.54|<0.001
72555114|NCT03086460|144641776|SUPERIORITY||Hazard Ratio (HR)|22.91|||<|0.001|TWO_SIDED|95.0|5.7|92.06|||Regression, Cox|||"Day 1~Comparison groups were:~Treatment F ( Perforomist® IS 40 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||92.06|5.70|<0.001
72618098|NCT02186171|144767515|SUPERIORITY||LS Mean Difference|10.9|STANDARD_ERROR_OF_MEAN|0.6|<|0.0001|TWO_SIDED|95.0|9.6|12.2||ANCOVA model adjusting for treatment, baseline BMD value, machine type, machine type-by-baseline BMD value, baseline testosterone level, geographic region, and using a variance structure allowing for heterogeneity between treatment groups.|ANCOVA|||||12.2|9.6|< 0.0001
72618099|NCT02186171|144767516|SUPERIORITY|The Hochberg procedure was employed to control the overall type 1 error for the percent change from baseline at 12 months in total hip and femoral neck to maintain the overall significance level at 0.05.|LS Mean Difference|3.0|STANDARD_ERROR_OF_MEAN|0.4|<|0.0001|TWO_SIDED|95.0|2.3|3.7||ANCOVA model adjusting for treatment, baseline BMD value, machine type, machine type-by-baseline BMD value, baseline testosterone level, geographic region, and using a variance structure allowing for heterogeneity between treatment groups.|ANCOVA|||||3.7|2.3|< 0.0001
72618100|NCT02186171|144767517|SUPERIORITY|The Hochberg procedure was employed to control the overall type 1 error for the percent change from baseline at 12 months in total hip and femoral neck to maintain the overall significance level at 0.05.|LS Mean Difference|2.4|STANDARD_ERROR_OF_MEAN|0.5|<|0.0001|TWO_SIDED|95.0|1.5|3.3||ANCOVA model adjusting for treatment, baseline BMD value, machine type, machine type-by-baseline BMD value, baseline testosterone level, geographic region, and using a variance structure allowing for heterogeneity between treatment groups.|ANCOVA|||||3.3|1.5|< 0.0001
72618101|NCT02186171|144767518|SUPERIORITY|The Hochberg procedure was employed to control the overall type 1 error for the percent change from baseline at 6 months at the lumbar spine, total hip and femoral neck BMD in order to maintain the overall significance level at 0.05.|LS Mean Difference|8.7|STANDARD_ERROR_OF_MEAN|0.5|<|0.0001|TWO_SIDED|95.0|7.6|9.7||ANCOVA model adjusting for treatment, baseline BMD value, machine type, machine type-by-baseline BMD value, baseline testosterone level, geographic region, and using a variance structure allowing for heterogeneity between treatment groups.|ANCOVA|||||9.7|7.6|< 0.0001
72618102|NCT02186171|144767519|SUPERIORITY|The Hochberg procedure was employed to control the overall type 1 error for the percent change from baseline at 6 months at the lumbar spine, total hip and femoral neck BMD in order to maintain the overall significance level at 0.05.|LS Mean Difference|1.4|STANDARD_ERROR_OF_MEAN|0.3|<|0.0001|TWO_SIDED|95.0|0.8|2.0||ANCOVA model adjusting for treatment, baseline BMD value, machine type, machine type-by-baseline BMD value, baseline testosterone level, geographic region, and using a variance structure allowing for heterogeneity between treatment groups.|ANCOVA|||||2.0|0.8|< 0.0001
72618103|NCT02186171|144767520|SUPERIORITY|The Hochberg procedure was employed to control the overall type 1 error for the percent change from baseline at 6 months at the lumbar spine, total hip and femoral neck BMD in order to maintain the overall significance level at 0.05.|LS Mean Difference|1.3|STANDARD_ERROR_OF_MEAN|0.4|=|0.0033|TWO_SIDED|95.0|0.4|2.1||ANCOVA model adjusting for treatment, baseline BMD value, machine type, machine type-by-baseline BMD value, baseline testosterone level, geographic region, and using a variance structure allowing for heterogeneity between treatment groups.|ANCOVA|||||2.1|0.4|= 0.0033
72371761|NCT00669409|144253476|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-19.4|STANDARD_ERROR_OF_MEAN|8.22|||TWO_SIDED|95.0|-35.6|-3.2||||||Change at Week 1, Stiffness: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-3.2|-35.6|
72618104|NCT06868667|144767521|OTHER||Hazard Ratio (HR)|0.4|||||TWO_SIDED|95.0|0.11|1.52|||||Hazard ratio was estimated using a Cox Proportional Hazards model stratified by the number of lines of prior therapy, prior bortezomib and revised international staging system (R-ISS) at screening, with a covariate of treatment.|||1.52|0.11|
72371762|NCT00669409|144253476|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-24.4|STANDARD_ERROR_OF_MEAN|10.86|||TWO_SIDED|95.0|-45.8|-2.9||||||Change at Week 1, Stiffness: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-2.9|-45.8|
72618105|NCT05330429|144767555|SUPERIORITY||Hazard Ratio (HR)|0.956||||0.9323|TWO_SIDED|95.0|0.339|2.691|||Unstratified Log-rank Test|2-Sided P-value was based on unstratified log-rank test.|Hazard ratio and its 95% CI were calculated using unstratified Cox proportional hazards regression model.|||2.691|0.339|0.9323
72618106|NCT05330429|144767558|SUPERIORITY||Hazard Ratio (HR)|0.299|||||TWO_SIDED|95.0|0.056|1.6|||||Hazard ratio and its 95% CI were calculated using unstratified Cox proportional hazards regression model.|||1.600|0.056|
72618107|NCT03572218|144767569|SUPERIORITY||Mean Difference (Net)|-0.3|STANDARD_ERROR_OF_MEAN|0.2||0.22|TWO_SIDED||||||Mixed Models Analysis|||||||0.22
72618108|NCT03572218|144767570|SUPERIORITY||Mean Difference (Net)|-0.2|STANDARD_ERROR_OF_MEAN|0.3||0.45|TWO_SIDED||||||Mixed Models Analysis|||||||0.45
72618109|NCT03572218|144767571|SUPERIORITY||Mean Difference (Net)|-4.4|STANDARD_ERROR_OF_MEAN|1.9||0.03|TWO_SIDED||||||Mixed Models Analysis|||WSSQ-Total||||0.03
72371763|NCT00669409|144253477|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-2.9|STANDARD_ERROR_OF_MEAN|7.86|||TWO_SIDED|95.0|-18.5|12.6||||||Change at Week 2, Pain: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||12.6|-18.5|
72555115|NCT03086460|144641776|SUPERIORITY||Hazard Ratio (HR)|1.76||||0.195|TWO_SIDED|95.0|0.75|4.13|||Regression, Cox|||"Day 1~Comparison groups were:~Treatment B (CHF 1531 pMDI 12 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||4.13|0.75|0.195
72618110|NCT03572218|144767571|SUPERIORITY||Mean Difference (Net)|-2.8|STANDARD_ERROR_OF_MEAN|1.1||0.02|TWO_SIDED||||||Mixed Models Analysis|||WSSQ-SD||||0.02
72618111|NCT03572218|144767571|SUPERIORITY||Mean Difference (Net)|-1.6|STANDARD_ERROR_OF_MEAN|1.2||0.19|TWO_SIDED||||||Mixed Models Analysis|||WSSQ-FNE||||0.19
72618112|NCT03572218|144767572|SUPERIORITY||Mean Difference (Net)|-3.5|STANDARD_ERROR_OF_MEAN|2.1||0.11|TWO_SIDED||||||Mixed Models Analysis|||WSSQ-Total||||0.11
72618113|NCT03572218|144767572|SUPERIORITY||Mean Difference (Net)|-2.6|STANDARD_ERROR_OF_MEAN|1.1||0.03|TWO_SIDED||||||Mixed Models Analysis|||WSSQ-SD||||0.03
72618114|NCT03572218|144767572|SUPERIORITY||Mean Difference (Net)|-0.8|STANDARD_ERROR_OF_MEAN|1.3||0.53|TWO_SIDED||||||Mixed Models Analysis|||WSSQ-FNE||||0.53
72618115|NCT03572218|144767573|SUPERIORITY||Mean Difference (Net)|-0.3|STANDARD_ERROR_OF_MEAN|0.2||0.12|TWO_SIDED||||||Mixed Models Analysis|||||||0.12
72618116|NCT03572218|144767574|SUPERIORITY||Mean Difference (Net)|-0.3|STANDARD_ERROR_OF_MEAN|0.2||0.09|TWO_SIDED||||||Mixed Models Analysis|||||||0.09
72618117|NCT03572218|144767575|SUPERIORITY||Mean Difference (Net)|-0.6|STANDARD_ERROR_OF_MEAN|2.9||0.84|TWO_SIDED||||||Mixed Models Analysis|||Estimated mean change score on the Impact of Weight on Quality of Life Questionnaire-Lite for Total score||||0.84
72618118|NCT03572218|144767575|SUPERIORITY||Mean Difference (Net)|0.9|STANDARD_ERROR_OF_MEAN|4.0||0.82|TWO_SIDED||||||Mixed Models Analysis|||Estimated mean change score on the Physical Function Subscale of the Impact of Weight on Quality of Life Questionnaire-Lite||||0.82
72618119|NCT03572218|144767575|SUPERIORITY||Mean Difference (Net)|3.7|STANDARD_ERROR_OF_MEAN|4.3||0.39|TWO_SIDED||||||Mixed Models Analysis|||Estimated mean change score on the Self Esteem Subscale of the Impact of Weight on Quality of Life Questionnaire-Lite||||0.39
72618120|NCT03572218|144767575|SUPERIORITY||Mean Difference (Net)|-4.0|STANDARD_ERROR_OF_MEAN|5.0||0.42|TWO_SIDED||||||Mixed Models Analysis|||Estimated mean change score on the Sexual Life Subscale of the Impact of Weight on Quality of Life Questionnaire-Lite||||0.42
72555116|NCT03086460|144641776|SUPERIORITY||Risk Ratio (RR)|2.46||||0.037|TWO_SIDED|95.0|1.06|5.72|||Regression, Cox|||"Day 1~Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||5.72|1.06|0.037
72555117|NCT03086460|144641776|SUPERIORITY||Hazard Ratio (HR)|2.24||||0.042|TWO_SIDED|95.0|1.03|4.86|||Regression, Cox|||"Day 1~Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||4.86|1.03|0.042
72555118|NCT03086460|144641776|SUPERIORITY||Hazard Ratio (HR)|1.4||||0.435|TWO_SIDED|95.0|0.6|3.23|||Regression, Cox|||"Day 1~Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment B (CHF 1531 pMDI 12 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||3.23|0.60|0.435
72555119|NCT03086460|144641776|SUPERIORITY||Hazard Ratio (HR)|1.27||||0.564|TWO_SIDED|95.0|0.56|2.89|||Regression, Cox|||"Day 1~Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment B (CHF 1531 pMDI 12 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||2.89|0.56|0.564
72555120|NCT03086460|144641776|SUPERIORITY|"Day 1~Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment C (CHF 1531 pMDI 24 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."|Hazard Ratio (HR)|0.91||||0.818|TWO_SIDED|95.0|0.41|2.01|||Regression, Cox|||||2.01|0.41|0.818
72555121|NCT01609257|144641789|SUPERIORITY_OR_OTHER|||||||0.674||||||No multiplicity adjustment.|Fisher Exact|||||||0.674
72555122|NCT01609257|144641796|SUPERIORITY_OR_OTHER|||||||0.001||||||Statistically significant at p\<0.05. No multiplicity adjustment.|Wilcoxon (Mann-Whitney)|||||||0.001
72555123|NCT01609257|144641797|SUPERIORITY_OR_OTHER|||||||0.008||||||Statistically significant at p\<0.05. No multiplicity adjustment.|Wilcoxon (Mann-Whitney)|||Score 1||||0.008
72555124|NCT01609257|144641797|SUPERIORITY_OR_OTHER|||||||0.037||||||Statistically significant at p\<0.05. No multiplicity adjustment.|Wilcoxon (Mann-Whitney)|||Score 2||||0.037
72555125|NCT01609257|144641798|SUPERIORITY_OR_OTHER|||||||0.199|||||||Wilcoxon (Mann-Whitney)|||||||0.199
72555126|NCT01609257|144641799|SUPERIORITY_OR_OTHER|||||||0.562||||||Comparison of % Positive|Fisher Exact|||Any Day 1 to 30||||0.562
72555127|NCT00761813|144641823|SUPERIORITY||Cox Proportional Hazard|0.83|||||TWO_SIDED|95.0|0.63|1.09||||||||1.09|.63|
72555128|NCT00761813|144641824|SUPERIORITY|||||||0.05|||||||Chi-squared|||||||0.05
72555129|NCT02125461|144641825|SUPERIORITY||Hazard Ratio (HR)|0.52|||<|0.0001|TWO_SIDED|95.0|0.42|0.65|||Log Rank|||Analysis performed using a stratified log rank test adjusting for age at randomization (\<65 vs ≥65), sex (male vs female), and smoking history (smoker vs non-smoker) with ties handled using the Breslow approach.||0.65|0.42|<0.0001
72555130|NCT02125461|144641826|SUPERIORITY||Hazard Ratio (HR)|0.68||||0.00251|TWO_SIDED|95.0|0.53|0.87|||Log Rank|||Analysis performed using a stratified log rank test adjusting for age at randomization (\<65 vs ≥65), sex (male vs female), and smoking history (smoker vs non-smoker) with ties handled using the Breslow approach.||0.87|0.53|0.00251
72555131|NCT02125461|144641827|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||Analysis performed using Fisher's exact test with mid p-value modification by subtracting half of the probability of the observed table from Fisher's p-value.||||<0.001
72555132|NCT02125461|144641831|SUPERIORITY||Hazard Ratio (HR)|0.53|||<|0.0001|TWO_SIDED|95.0|0.41|0.68|||Log Rank|||Analysis performed using a stratified log rank test adjusting for age at randomization (\<65 vs ≥65), sex (male vs female), and smoking history (smoker vs non-smoker) with ties handled using the Breslow approach.||0.68|0.41|<0.0001
72555133|NCT02125461|144641832|SUPERIORITY|||||||0.005||||||P-value generated based on z-test where z-test statistic is the ratio of the log-transformed ratio of the cumulative hazards in the 2 treatment arms divided by the square root of the variance.|z-test|The variance was estimated using the delta method and Greenwood's formula.||||||0.005
72555134|NCT02125461|144641833|SUPERIORITY||Hazard Ratio (HR)|0.58|||<|0.0001|TWO_SIDED|95.0|0.46|0.73|||Log Rank|||Analysis performed using a stratified log rank test adjusting for age at randomization (\<65 vs ≥65), sex (male vs female), and smoking history (smoker vs non-smoker) with ties handled using the Breslow approach.||0.73|0.46|<0.0001
72371764|NCT00669409|144253477|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-14.7|STANDARD_ERROR_OF_MEAN|7.86|||TWO_SIDED|95.0|-30.3|0.8||||||Change at Week 2, Pain: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||0.8|-30.3|
72555135|NCT02125461|144641834|SUPERIORITY||Hazard Ratio (HR)|0.95||||0.664|TWO_SIDED|95.0|0.77|1.18||Analysis performed using a stratified log rank test adjusting for age at randomization (\<65 vs ≥65), sex (male vs female), and smoking history (smoker vs non-smoker) with ties handled using the Breslow approach.|Log Rank|||The hazard ratio and CI were estimated from a stratified Cox proportional hazards model with the Breslow method to control for ties, the stratification factors age at randomization (\<65 vs ≥65), sex (male vs female) and smoking history (smoker vs non-smoker) in the strata statement, and the CI calculated using a profile likelihood approach.||1.18|0.77|0.664
72555136|NCT02125461|144641835|SUPERIORITY||Hazard Ratio (HR)|1.06||||0.522|TWO_SIDED|95.0|0.88|1.29||Analysis performed using a stratified log rank test adjusting for age at randomization (\<65 vs ≥65), sex (male vs female), and smoking history (smoker vs non-smoker) with ties handled using the Breslow approach.|Log Rank|||Treatment comparison for dyspnea. The hazard ratio and CI were estimated from a stratified Cox proportional hazards model with the Breslow method to control for ties, the stratification factors age at randomization (\<65 vs ≥65), sex (male vs female) and smoking history (smoker vs non-smoker) in the strata statement, and the CI calculated using a profile likelihood approach.||1.29|0.88|0.522
72555137|NCT02125461|144641835|SUPERIORITY||Hazard Ratio (HR)|0.91||||0.38|TWO_SIDED|95.0|0.74|1.12||Analysis performed using a stratified log rank test adjusting for age at randomization (\<65 vs ≥65), sex (male vs female), and smoking history (smoker vs non-smoker) with ties handled using the Breslow approach.|Log Rank|||Treatment comparison for cough. The hazard ratio and CI were estimated from a stratified Cox proportional hazards model with the Breslow method to control for ties, the stratification factors age at randomization (\<65 vs ≥65), sex (male vs female) and smoking history (smoker vs non-smoker) in the strata statement, and the CI calculated using a profile likelihood approach.||1.12|0.74|0.380
72555138|NCT02125461|144641835|SUPERIORITY||Hazard Ratio (HR)|0.75||||0.048|TWO_SIDED|95.0|0.56|1.0||Analysis performed using a stratified log rank test adjusting for age at randomization (\<65 vs ≥65), sex (male vs female), and smoking history (smoker vs non-smoker) with ties handled using the Breslow approach.|Log Rank|||Treatment comparison for hemoptysis. The hazard ratio and CI were estimated from a stratified Cox proportional hazards model with the Breslow method to control for ties, the stratification factors age at randomization (\<65 vs ≥65), sex (male vs female) and smoking history (smoker vs non-smoker) in the strata statement, and the CI calculated using a profile likelihood approach.||1.00|0.56|0.048
72555139|NCT02125461|144641835|SUPERIORITY||Hazard Ratio (HR)|0.94||||0.626|TWO_SIDED|95.0|0.75|1.19||Analysis performed using a stratified log rank test adjusting for age at randomization (\<65 vs ≥65), sex (male vs female), and smoking history (smoker vs non-smoker) with ties handled using the Breslow approach.|Log Rank|||Treatment comparison for chest pain. The hazard ratio and CI were estimated from a stratified Cox proportional hazards model with the Breslow method to control for ties, the stratification factors age at randomization (\<65 vs ≥65), sex (male vs female) and smoking history (smoker vs non-smoker) in the strata statement, and the CI calculated using a profile likelihood approach.||1.19|0.75|0.626
72555140|NCT00835484|144641838|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model containing factors for sequence of products, subjects within sequence, periods, and products was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|97.15||||||90.0|91.77|102.83|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||102.83|91.77|
72555141|NCT00835484|144641839|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model containing factors for sequence of products, subjects within sequence, periods, and products was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|100.8||||||90.0|95.1|106.84|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||106.84|95.1|
72555142|NCT00835484|144641840|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model containing factors for sequence of products, subjects within sequence, periods, and products was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|101.39||||||90.0|95.89|107.2|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||107.2|95.89|
72555143|NCT04994535|144641842|SUPERIORITY||Difference (%)|30.9|||<|0.0001|TWO_SIDED|95.0|24.5|37.4||P-value derived from Cochran-Mantel-Haenszel (CMH) model stratified by investigator site and baseline C-APPS.|Cochran-Mantel-Haenszel|||||37.4|24.5|<.0001
72555144|NCT04994535|144641843|SUPERIORITY||Difference (%)|38.9|||<|0.0001|TWO_SIDED|95.0|31.3|46.4||P-value derived from Cochran-Mantel-Haenszel (CMH) model stratified by investigator site and baseline C-APPS.|Cochran-Mantel-Haenszel|||||46.4|31.3|<0.0001
72555145|NCT04994535|144641844|SUPERIORITY||Difference (%)|36.9|||<|0.0001|TWO_SIDED|95.0|29.1|44.7||P-value derived from Cochran-Mantel-Haenszel (CMH) model stratified by investigator site and baseline C-APPS.|Cochran-Mantel-Haenszel|||||44.7|29.1|<0.0001
72555146|NCT04994535|144641847|SUPERIORITY||Difference (%)|50.2|||<|0.0001|TWO_SIDED|95.0|42.0|58.3||P-value derived from Cochran-Mantel-Haenszel (CMH) model stratified by investigator site and baseline C-APPS.|Cochran-Mantel-Haenszel|||||58.3|42.0|<.0001
72555147|NCT04994535|144641848|SUPERIORITY||Difference (%)|27.1|||<|0.0001|TWO_SIDED|95.0|18.1|36.1||P-value derived from Cochran-Mantel-Haenszel (CMH) model stratified by investigator site and baseline C-APPS.|Cochran-Mantel-Haenszel|||||36.1|18.1|<.0001
72555148|NCT04994535|144641849|SUPERIORITY||Difference (%)|35.8|||<|0.0001|TWO_SIDED|95.0|27.4|44.2||P-value derived from Cochran-Mantel-Haenszel (CMH) model stratified by investigator site and baseline C-APPS.|Cochran-Mantel-Haenszel|||||44.2|27.4|<.0001
72555149|NCT04994535|144641850|SUPERIORITY||Difference (SE)|-4.4|STANDARD_ERROR_OF_MEAN|0.51|<|0.0001|TWO_SIDED|95.0|-5.4|-3.4||P-value derived from ANCOVA model stratified by investigator site and baseline C-APPS with baseline value as a factor.|ANCOVA|||||-3.4|-5.4|<.0001
72555150|NCT04994535|144641853|SUPERIORITY||Difference (%)|42.9|||<|0.0001|TWO_SIDED|95.0|34.8|51.0||P-value derived from Cochran-Mantel-Haenszel (CMH) model stratified by investigator site and baseline C-APPS.|Cochran-Mantel-Haenszel|||||51.0|34.8|<0.0001
72555151|NCT04994535|144641854|SUPERIORITY||Difference (%)|49.4|||<|0.0001|TWO_SIDED|95.0|40.8|58.1||P-value derived from Cochran-Mantel-Haenszel (CMH) model stratified by investigator site and baseline C-APPS.|Cochran-Mantel-Haenszel|||||58.1|40.8|<0.0001
72555152|NCT04994535|144641855|SUPERIORITY||Difference (%)|28.8|||<|0.0001|TWO_SIDED|95.0|19.4|38.2||P-value derived from Cochran-Mantel-Haenszel (CMH) model stratified by investigator site and baseline C-APPS.|Cochran-Mantel-Haenszel|||||38.2|19.4|<0.0001
72555153|NCT04994535|144641856|SUPERIORITY||Difference (%)|35.9|||<|0.0001|TWO_SIDED|95.0|27.2|44.6||P-value derived from Cochran-Mantel-Haenszel (CMH) model stratified by investigator site and baseline C-APPS.|Cochran-Mantel-Haenszel|||||44.6|27.2|<0.0001
72555154|NCT04994535|144641857|SUPERIORITY||Difference (SE)|-4.7|STANDARD_ERROR_OF_MEAN|0.54|<|0.0001|TWO_SIDED|95.0|-5.8|-3.7||P-value derived from ANCOVA model stratified by investigator site and baseline C-APPS with baseline value as a factor.|ANCOVA|||||-3.7|-5.8|<0.0001
72555155|NCT04994535|144641858|SUPERIORITY||Difference (SE)|-4.9|STANDARD_ERROR_OF_MEAN|0.58|<|0.0001|TWO_SIDED|95.0|-6.0|-3.7||P-value derived from ANCOVA model stratified by investigator site and baseline C-APPS with baseline value as a factor.|ANCOVA|||Day 30||-3.7|-6.0|<0.0001
72555156|NCT04994535|144641858|SUPERIORITY||Difference (SE)|-4.7|STANDARD_ERROR_OF_MEAN|0.59|<|0.0001|TWO_SIDED|95.0|-5.9|-3.6||P-value derived from ANCOVA model stratified by investigator site and baseline C-APPS with baseline value as a factor.|ANCOVA|||Day 60||-3.6|-5.9|<0.0001
72555157|NCT04994535|144641858|SUPERIORITY||Difference (SE)|-3.9|STANDARD_ERROR_OF_MEAN|0.54|<|0.0001|TWO_SIDED|95.0|-4.9|-2.8||P-value derived from ANCOVA model stratified by investigator site and baseline C-APPS with baseline value as a factor.|ANCOVA|||Day 90||-2.8|-4.9|<0.0001
72555158|NCT02115347|144641896|SUPERIORITY_OR_OTHER||Ratio (Test/Reference) of Adjusted Means|87.31|||||TWO_SIDED|90.0|68.01|112.08|||||ANOVA model with hepatic function group as a fixed effect, ratios (and 90% confidence intervals \[CIs\]) were expressed as percentages, Moderate Hepatic Impairment (Test), Normal Hepatic Function (Reference).|||112.08|68.01|
72555159|NCT02115347|144641897|SUPERIORITY_OR_OTHER||Ratio (Test/Reference) of Adjusted Means|87.43|||||TWO_SIDED|90.0|68.11|112.22|||||ANOVA model with hepatic function group as a fixed effect, ratios (and 90% confidence intervals \[CIs\]) were expressed as percentages, Moderate Hepatic Impairment (Test), Normal Hepatic Function (Reference).|||112.22|68.11|
72555160|NCT02115347|144641898|SUPERIORITY_OR_OTHER||Ratio (Test/Reference) of Adjusted Means|95.81|||||TWO_SIDED|90.0|72.4|126.79|||||ANOVA model with hepatic function group as a fixed effect, ratios (and 90% confidence intervals \[CIs\]) were expressed as percentages, Moderate Hepatic Impairment (Test), Normal Hepatic Function (Reference).|||126.79|72.40|
72555161|NCT02115347|144641899|SUPERIORITY_OR_OTHER||Ratio (Test/Reference) of Adjusted Means|95.92|||||TWO_SIDED|90.0|72.46|126.97|||||ANOVA model with hepatic function group as a fixed effect, ratios (and 90% confidence intervals \[CIs\]) were expressed as percentages, Moderate Hepatic Impairment (Test), Normal Hepatic Function (Reference).|||126.97|72.46|
72555162|NCT02115347|144641900|SUPERIORITY_OR_OTHER||Ratio (Test/Reference) of Adjusted Means|78.7|||||TWO_SIDED|90.0|65.74|94.23|||||ANOVA model with hepatic function group as a fixed effect, ratios (and 90% confidence intervals \[CIs\]) were expressed as percentages, Moderate Hepatic Impairment (Test), Normal Hepatic Function (Reference).|||94.23|65.74|
72555163|NCT02115347|144641901|SUPERIORITY_OR_OTHER||Ratio (Test/Reference) of Adjusted Means|86.52|||||TWO_SIDED|90.0|70.49|106.2|||||ANOVA model with hepatic function group as a fixed effect, ratios (and 90% confidence intervals \[CIs\]) were expressed as percentages, Moderate Hepatic Impairment (Test), Normal Hepatic Function (Reference).|||106.20|70.49|
72555164|NCT00834340|144641903|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Geometric Test/Ref Ratio x 100|101.0||||||90.0|92.2|111.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||111|92.2|
72555165|NCT00834340|144641904|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Geometric Test/Ref Ratio x 100|98.5||||||90.0|94.0|103.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||103|94.0|
72555166|NCT00834340|144641905|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Geometric Test/Ref Ratio x 100|102.0||||||90.0|98.7|105.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||105|98.7|
72555167|NCT02294786|144641915|SUPERIORITY||Difference in Percentages|-4.8||||0.775|TWO_SIDED|95.0|-29.2|20.0|||Chi-squared|||Cycle 1-3 (up to 9 weeks)||20.0|-29.2|0.775
72555168|NCT01667679|144641938|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.39|STANDARD_ERROR_OF_MEAN|0.824|<|0.0001|TWO_SIDED|95.0|1.76|5.01|||ANCOVA|||||5.01|1.76|<0.0001
72555169|NCT01667679|144641939|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.66|STANDARD_ERROR_OF_MEAN|1.105||0.0013|TWO_SIDED|95.0|1.47|5.85|||ANCOVA||mild attacks|||5.85|1.47|0.0013
72555170|NCT01667679|144641939|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.76|STANDARD_ERROR_OF_MEAN|0.971||0.0002|TWO_SIDED|95.0|1.84|5.68|||ANCOVA||moderate/severe attacks|||5.68|1.84|0.0002
72555171|NCT01667679|144641940|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.16||||0.3549|TWO_SIDED|95.0|0.85|1.6|||ANCOVA||10 minutes post-dose|||1.60|0.85|0.3549
72432395|NCT02696785|144377183|SUPERIORITY||LSMean Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.77||0.182|TWO_SIDED|95.0|-2.6|0.5|||Mixed Models Analysis|||||0.5|-2.6|0.182
72555172|NCT01667679|144641940|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.51||||0.0005|TWO_SIDED|95.0|1.2|1.9|||ANCOVA||15 minutes post-dose|||1.90|1.20|0.0005
72555173|NCT01667679|144641940|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.79|||<|0.0001|TWO_SIDED|95.0|1.45|2.21|||ANCOVA||30 minutes post-dose|||2.21|1.45|<0.0001
72555174|NCT01667679|144641940|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.56||||0.0002|TWO_SIDED|95.0|1.24|1.96|||ANCOVA||45 minutes post-dose|||1.96|1.24|0.0002
72555175|NCT01667679|144641940|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.37||||0.0057|TWO_SIDED|95.0|1.1|1.71|||ANCOVA||60 minutes post-dose|||1.71|1.10|0.0057
72555176|NCT01667679|144641940|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.26||||0.0654|TWO_SIDED|95.0|0.99|1.61|||ANCOVA||90 minutes post-dose|||1.61|0.99|0.0654
72555177|NCT01667679|144641940|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.15||||0.2894|TWO_SIDED|95.0|0.89|1.49|||ANCOVA||120 minutes post-dose|||1.49|0.89|0.2894
72555178|NCT01667679|144641941|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.85||||0.1771|TWO_SIDED|95.0|0.76|4.54|||ANCOVA||10 minutes post-dose|||4.54|0.76|0.1771
72555179|NCT01667679|144641941|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.03||||0.0077|TWO_SIDED|95.0|1.21|3.42|||ANCOVA||15 minutes post-dose|||3.42|1.21|0.0077
72555180|NCT01667679|144641941|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.82||||0.0003|TWO_SIDED|95.0|1.32|2.5|||ANCOVA||30 minutes post-dose|||2.50|1.32|0.0003
72555181|NCT01667679|144641941|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.64|||<|0.0001|TWO_SIDED|95.0|1.29|2.09|||ANCOVA||45 minutes post-dose|||2.09|1.29|<0.0001
72555182|NCT01667679|144641941|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.41||||0.0016|TWO_SIDED|95.0|1.14|1.74|||ANCOVA||60 minutes post-dose|||1.74|1.14|0.0016
72555183|NCT01667679|144641941|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.36||||0.0059|TWO_SIDED|95.0|1.09|1.69|||ANCOVA||90 minutes post-dose|||1.69|1.09|0.0059
72555184|NCT01667679|144641941|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.14||||0.2717|TWO_SIDED|95.0|0.91|1.42|||ANCOVA||120 minutes post-dose|||1.42|0.91|0.2717
72555185|NCT01667679|144641942|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.24||||0.2426|TWO_SIDED|95.0|0.87|1.77|||ANCOVA||10 minutes post-dose|||1.77|0.87|0.2426
72555186|NCT01667679|144641942|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.49||||0.0069|TWO_SIDED|95.0|1.12|1.99|||ANCOVA||15 minutes post-dose|||1.99|1.12|0.0069
72555187|NCT01667679|144641942|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.94|||<|0.0001|TWO_SIDED|95.0|1.47|2.56|||ANCOVA||30 minutes post-dose|||2.56|1.47|<0.0001
72555188|NCT01667679|144641942|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.68||||0.0004|TWO_SIDED|95.0|1.26|2.23|||ANCOVA||45 minutes post-dose|||2.23|1.26|0.0004
72555189|NCT01667679|144641942|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.6||||0.0008|TWO_SIDED|95.0|1.22|2.11|||ANCOVA||60 minutes post-dose|||2.11|1.22|0.0008
72555190|NCT01667679|144641942|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.38||||0.0272|TWO_SIDED|95.0|1.04|1.83|||ANCOVA||90 minutes post-dose|||1.83|1.04|0.0272
72555191|NCT01667679|144641942|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.21||||0.2085|TWO_SIDED|95.0|0.9|1.62|||ANCOVA||120 minutes post-dose|||1.62|0.90|0.2085
72555192|NCT01667679|144641944|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.021||0.3562|TWO_SIDED|95.0|-0.06|0.02|||ANCOVA||10 minutes post-dose|||0.02|-0.06|0.3562
72555193|NCT01667679|144641944|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.08|STANDARD_ERROR_OF_MEAN|0.029||0.0063|TWO_SIDED|94.0|-0.14|-0.02|||ANCOVA||15 minutes post-dose|||-0.02|-0.14|0.0063
72555194|NCT01667679|144641944|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.19|STANDARD_ERROR_OF_MEAN|0.039|<|0.0001|TWO_SIDED|95.0|-0.26|-0.11|||ANCOVA||30 minutes post-dose|||-0.11|-0.26|< 0.0001
72555195|NCT01667679|144641944|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.17|STANDARD_ERROR_OF_MEAN|0.046||0.0005|TWO_SIDED|95.0|-0.26|-0.07|||ANCOVA||45 minutes post-dose|||-0.07|-0.26|0.0005
72555196|NCT01667679|144641944|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.14|STANDARD_ERROR_OF_MEAN|0.048||0.004|TWO_SIDED|95.0|-0.24|-0.05|||ANCOVA||60 minutes post-dose|||-0.05|-0.24|0.0040
72555197|NCT01667679|144641944|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.11|STANDARD_ERROR_OF_MEAN|0.052||0.0333|TWO_SIDED|95.0|-0.21|-0.01|||ANCOVA||90 minutes post-dose|||-0.01|-0.21|0.0333
72555198|NCT01667679|144641944|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.04|STANDARD_ERROR_OF_MEAN|0.052||0.4031|TWO_SIDED|95.0|-0.15|0.06|||ANCOVA||120 minutes post-dose|||0.06|-0.15|0.4031
72555199|NCT01667679|144641945|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.04|STANDARD_ERROR_OF_MEAN|0.019||0.0181|TWO_SIDED|95.0|-0.08|-0.01|||ANCOVA||10 minutes post-dose|||-0.01|-0.08|0.0181
72555200|NCT01667679|144641945|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.09|STANDARD_ERROR_OF_MEAN|0.026||0.0003|TWO_SIDED|95.0|-0.14|-0.04|||ANCOVA||15 minutes post-dose|||-0.04|-0.14|0.0003
72555201|NCT01667679|144641945|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.16|STANDARD_ERROR_OF_MEAN|0.035|<|0.0001|TWO_SIDED|95.0|-0.23|-0.09|||ANCOVA||30 minutes post-dose|||-0.09|-0.23|< 0.0001
72555202|NCT01667679|144641945|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.17|STANDARD_ERROR_OF_MEAN|0.043||0.0001|TWO_SIDED|95.0|-0.25|-0.08|||ANCOVA||45 minutes post-dose|||-0.08|-0.25|0.0001
72555203|NCT01667679|144641945|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.16|STANDARD_ERROR_OF_MEAN|0.047||0.0006|TWO_SIDED|95.0|-0.26|-0.07|||ANCOVA||60 minutes post-dose|||-0.07|-0.26|0.0006
72555204|NCT01667679|144641945|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.11|STANDARD_ERROR_OF_MEAN|0.048||0.0189|TWO_SIDED|95.0|-0.21|-0.02|||ANCOVA||90 minutes post-dose|||-0.02|-0.21|0.0189
72555205|NCT01667679|144641945|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.07|STANDARD_ERROR_OF_MEAN|0.05||0.1704|TWO_SIDED|95.0|-0.17|0.03|||ANCOVA||120 minutes post-dose|||0.03|-0.17|0.1704
72432396|NCT02696785|144377184|SUPERIORITY||LSMean Difference|-10.07|STANDARD_ERROR_OF_MEAN|1.588|<|0.001|TWO_SIDED|95.0|-13.2|-6.9|||ANCOVA|||||-6.9|-13.2|<0.001
72555206|NCT02777580|144641976|OTHER|||||||0.05|||||||Chi-squared|||||||0.05
72555207|NCT02777580|144641977|OTHER||Risk Ratio (RR)|0.96|||||TWO_SIDED|95.0|0.62|1.48||||||||1.48|0.62|
72555208|NCT02777580|144641978|OTHER||Risk Ratio (RR)|4.57|||||TWO_SIDED|95.0|0.58|35.8||||||||35.8|0.58|
72555209|NCT02777580|144641979|OTHER||Risk Ratio (RR)|1.27|||||TWO_SIDED|95.0|0.25|6.48||||||||6.48|0.25|
72555210|NCT05630885|144642132|SUPERIORITY||Slope|0.984||||0.65|TWO_SIDED|95.0|0.916|1.056||A-priori threshold for statistical significance is at p \< 0.05. No adjustments for multiple comparisons were done.|Regression, Linear|Outcome was log10-transformed. Model adjusted for statin-use. Analysis used multiple imputation for missing data.|Estimate obtained from regression on log10-transformed scale was back-transformed to the original scale and rounded to 3 decimal places. It reflects the relative geometric mean fold-change in the TBR from baseline for CVC compared to placebo.|Evaluates whether CVC, compared to placebo, changes arterial inflammation in the MDS of the index vessel, adjusting for statin-use. The study was powered to detect a between-group difference of 0.046 in log10 MDS TBR (10% relative fold-change), assuming a null difference of 0 in log10 MDS TBR (a ratio of 1 in absolute-scale), a standard deviation of 0.065 of change in log10 TBR, and 75 evaluable participants.||1.056|0.916|0.65
72555211|NCT05630885|144642132|OTHER|Statistical test for interaction.||||||0.4||||||P-value for modification of the CVC treatment effect by subgroups defined by statin-use is presented. A-priori threshold for statistical significance is at p \< 0.05. No adjustments for multiple comparisons were done.|Regression, Linear|Outcome was log10-transformed. Model adjusted for statin-use and its interaction with treatment. Analysis used multiple imputation for missing data.||Evaluates whether CVC, compared to placebo, changes arterial inflammation in the MDS of the index vessel differently by statin-use at study entry (use versus no-use).||||0.40
72555212|NCT05630885|144642132|OTHER|Statistical test for interaction.||||||0.63||||||P-value for modification of the CVC treatment effect by subgroups defined by sex is presented. A-priori threshold for statistical significance is at p \< 0.05. No adjustments for multiple comparisons were done.|Regression, Linear|Outcome was log10-transformed. Model adjusted for sex (F vs M) and its interaction with treatment. Analysis used multiple imputation for missing data.||Evaluates whether CVC, compared to placebo, changes arterial inflammation in the MDS of the index vessel differently by sex (female versus male).||||0.63
72618121|NCT03572218|144767575|SUPERIORITY||Mean Difference (Net)|-2.0|STANDARD_ERROR_OF_MEAN|4.3||0.64|TWO_SIDED||||||Mixed Models Analysis|||Estimated mean change score on the Work Subscale of the Impact of Weight on Quality of Life Questionnaire-Lite||||0.64
72618122|NCT03572218|144767575|SUPERIORITY||Mean Difference (Net)|-2.0|STANDARD_ERROR_OF_MEAN|3.6||0.59|TWO_SIDED||||||Mixed Models Analysis|||Estimated mean change score on the Public Distress Subscale of the Impact of Weight on Quality of Life Questionnaire-Lite||||0.59
72371765|NCT00669409|144253477|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|12.4|STANDARD_ERROR_OF_MEAN|7.92|||TWO_SIDED|95.0|-3.2|28.1||||||Change at Week 2, Pain: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||28.1|-3.2|
72432397|NCT02696785|144377184|SUPERIORITY||LSMean Difference|-9.51|STANDARD_ERROR_OF_MEAN|1.591|<|0.001|TWO_SIDED|95.0|-12.6|-6.4|||ANCOVA|||||-6.4|-12.6|<0.001
72555213|NCT05630885|144642132|OTHER|Statistical test for interaction.||||||0.71||||||P-value for modification of the CVC treatment effect by subgroups defined by race is presented. A-priori threshold for statistical significance is at p \< 0.05. No adjustments for multiple comparisons were done.|Regression, Linear|Outcome was log10-transformed. Model adjusted for race and its interaction with treatment. Analysis used multiple imputation for missing data.||Evaluates whether CVC, compared to placebo, changes arterial inflammation in the MDS of the index vessel differently by race (Black/African-American versus Non-Black/African-American).||||0.71
72555214|NCT05630885|144642133|SUPERIORITY||Slope|0.996||||0.91|TWO_SIDED|95.0|0.93|1.067||A-priori threshold for statistical significance is at p \< 0.05. No adjustments for multiple comparisons were done.|Regression, Linear|Outcome was log10-transformed. Model adjusted for statin-use.|Estimate obtained from regression on log10-transformed scale was back-transformed to the original scale and rounded to 3 decimal places. It reflects the relative geometric mean fold-change in the TBR from baseline for CVC compared to placebo.|Evaluates whether CVC, compared to placebo, changes arterial inflammation in the aorta adjusting for statin-use.||1.067|0.930|0.91
72618123|NCT03572218|144767576|SUPERIORITY||Mean Difference (Net)|-1.7|STANDARD_ERROR_OF_MEAN|3.0||0.58|TWO_SIDED||||||Mixed Models Analysis|||Estimated mean change score on the Impact of Weight on Quality of Life Questionnaire-Lite for Total score||||0.58
72618124|NCT03572218|144767576|SUPERIORITY||Mean Difference (Net)|-0.5|STANDARD_ERROR_OF_MEAN|4.0||0.89|TWO_SIDED||||||Mixed Models Analysis|||Estimated mean change score on the Physical Function Subscale of the Impact of Weight on Quality of Life Questionnaire-Lite||||0.89
72618125|NCT03572218|144767576|SUPERIORITY||Mean Difference (Net)|0.6|STANDARD_ERROR_OF_MEAN|4.7||0.9|TWO_SIDED||||||Mixed Models Analysis|||Estimated mean change score on the Self Esteem Subscale of the Impact of Weight on Quality of Life Questionnaire-Lite||||0.90
72618126|NCT03572218|144767576|SUPERIORITY||Mean Difference (Net)|-7.1|STANDARD_ERROR_OF_MEAN|5.0||0.16|TWO_SIDED||||||Mixed Models Analysis|||Estimated mean change score on the Sexual Life Subscale of the Impact of Weight on Quality of Life Questionnaire-Lite||||0.16
72618127|NCT03572218|144767576|SUPERIORITY||Mean Difference (Net)|1.8|STANDARD_ERROR_OF_MEAN|4.3||0.68|TWO_SIDED||||||Mixed Models Analysis|||Estimated mean change score on the Work Subscale of the Impact of Weight on Quality of Life Questionnaire-Lite||||0.68
72618128|NCT03572218|144767576|SUPERIORITY||Mean Difference (Net)|-1.3|STANDARD_ERROR_OF_MEAN|3.6||0.72|TWO_SIDED||||||Mixed Models Analysis|||Estimated mean change score on the Public Distress Subscale of the Impact of Weight on Quality of Life Questionnaire-Lite||||0.72
72618129|NCT03572218|144767577|SUPERIORITY||Mean Difference (Net)|-3.0|STANDARD_ERROR_OF_MEAN|1.7||0.08|TWO_SIDED||||||Mixed Models Analysis|||||||0.08
72618130|NCT03572218|144767578|SUPERIORITY||Mean Difference (Net)|-2.9|STANDARD_ERROR_OF_MEAN|1.7||0.1|TWO_SIDED||||||Mixed Models Analysis|||||||0.10
72618131|NCT03572218|144767579|SUPERIORITY||Mean Difference (Net)|-0.9|STANDARD_ERROR_OF_MEAN|1.1||0.4|TWO_SIDED||||||Mixed Models Analysis|||||||0.40
72618132|NCT03572218|144767580|SUPERIORITY||Mean Difference (Net)|-0.03|STANDARD_ERROR_OF_MEAN|1.1||0.98|TWO_SIDED||||||Mixed Models Analysis|||||||0.98
72618133|NCT03572218|144767581|SUPERIORITY||Mean Difference (Net)|9.7|STANDARD_ERROR_OF_MEAN|6.5||0.14|TWO_SIDED||||||Mixed Models Analysis|||||||0.14
72618134|NCT03572218|144767582|SUPERIORITY||Mean Difference (Net)|12.1|STANDARD_ERROR_OF_MEAN|6.5||0.06|TWO_SIDED||||||Mixed Models Analysis|||||||0.06
72618135|NCT03572218|144767583|SUPERIORITY||Mean Difference (Net)|1.1|STANDARD_ERROR_OF_MEAN|4.4||0.8|TWO_SIDED||||||Mixed Models Analysis|||||||0.80
72618136|NCT03572218|144767584|SUPERIORITY||Mean Difference (Net)|3.1|STANDARD_ERROR_OF_MEAN|4.4||0.49|TWO_SIDED||||||Mixed Models Analysis|||||||0.49
72618137|NCT03572218|144767585|SUPERIORITY||Mean Difference (Net)|1.4|STANDARD_ERROR_OF_MEAN|1.4||0.31|TWO_SIDED||||||Mixed Models Analysis|||||||0.31
72618138|NCT03572218|144767586|SUPERIORITY||Mean Difference (Net)|0.8|STANDARD_ERROR_OF_MEAN|1.3||0.54|TWO_SIDED||||||Mixed Models Analysis|||||||0.54
72618139|NCT03572218|144767587|SUPERIORITY||Mean Difference (Net)|-0.2|STANDARD_ERROR_OF_MEAN|2.2||0.94|TWO_SIDED||||||Mixed Models Analysis|||Systolic Blood Pressure||||0.94
72555215|NCT05630885|144642133|SUPERIORITY||Slope|0.98||||0.64|TWO_SIDED|95.0|0.901|1.066||A-priori threshold for statistical significance is at p \< 0.05. No adjustments for multiple comparisons were done.|Regression, Linear|Outcome was log10-transformed. Model adjusted for statin-use.|Estimate obtained from regression on log10-transformed scale was back-transformed to the original scale and rounded to 3 decimal places. It reflects the relative geometric mean fold-change in the TBR from baseline for CVC compared to placebo.|Evaluates whether CVC, compared to placebo, changes arterial inflammation in the right and left carotid arteries adjusting for statin-use.||1.066|0.901|0.64
72555216|NCT05630885|144642134|SUPERIORITY||Slope|1.01||||0.79|TWO_SIDED|95.0|0.939|1.087||A-priori threshold for statistical significance is at p \< 0.05. No adjustments for multiple comparisons were done.|Regression, Linear|Outcome was log10-transformed. Model adjusted for statin-use.|Estimate obtained from regression on log10-transformed scale was back-transformed to the original scale and rounded to 3 decimal places. It reflects the relative geometric mean fold-change in the SUV from baseline for CVC compared to placebo.|Evaluates whether CVC, compared to placebo, changes arterial inflammation in the aorta adjusting for statin-use.||1.087|0.939|0.79
72555217|NCT05630885|144642134|SUPERIORITY||Slope|1.017||||0.69|TWO_SIDED|95.0|0.935|1.106||A-priori threshold for statistical significance is at p \< 0.05. No adjustments for multiple comparisons were done.|Regression, Linear|Outcome was log10-transformed. Model adjusted for statin-use.|Estimate obtained from regression on log10-transformed scale was back-transformed to the original scale and rounded to 3 decimal places. It reflects the relative geometric mean fold-change in the SUV from baseline for CVC compared to placebo.|Evaluates whether CVC, compared to placebo, changes arterial inflammation in the right and left carotid arteries adjusting for statin-use.||1.106|0.935|0.69
72555218|NCT05630885|144642135|SUPERIORITY||Slope|2.5||||0.49|TWO_SIDED|95.0|-4.6|9.6||A-priori threshold for statistical significance is at p \< 0.05. No adjustments for multiple comparisons were done.|Regression, Linear|Model adjusted for statin-use.|Estimate reflects the relative mean change in fasting glucose from baseline for CVC compared to placebo.|Evaluates whether CVC, compared to placebo, changes levels of fasting glucose adjusting for statin-use.||9.6|-4.6|0.49
72555219|NCT05630885|144642136|SUPERIORITY||Slope|1.07||||0.62|TWO_SIDED|95.0|0.81|1.43||A-priori threshold for statistical significance is at p \< 0.05. No adjustments for multiple comparisons were done.|Regression, Linear|Outcome was log10-transformed. Model adjusted for statin-use.|Estimate obtained from regression on log10-transformed scale was back-transformed to the original scale. It reflects the relative geometric mean fold-change in fasting insulin from baseline for CVC compared to placebo.|Evaluates whether CVC, compared to placebo, changes levels of fasting insulin adjusting for statin-use.||1.43|0.81|0.62
72555220|NCT05630885|144642136|SUPERIORITY||Slope|1.09||||0.61|TWO_SIDED|95.0|0.78|1.54||A-priori threshold for statistical significance is at p \< 0.05. No adjustments for multiple comparisons were done.|Regression, Linear|Outcome was log10-transformed. Model adjusted for statin-use.|Estimate obtained from regression on log10-transformed scale was back-transformed to the original scale. It reflects the relative geometric mean fold-change in HOMA-IR from baseline for CVC compared to placebo.|Evaluates whether CVC, compared to placebo, changes levels of HOMA-IR adjusting for statin-use.||1.54|0.78|0.61
72555221|NCT05630885|144642137|SUPERIORITY||Slope|0.97||||0.91|TWO_SIDED|95.0|0.62|1.52||A-priori threshold for statistical significance is at p \< 0.05. No adjustments for multiple comparisons were done.|Regression, Linear|Outcome was log10-transformed. Model adjusted for statin-use.|Estimate obtained from regression on log10-transformed scale was back-transformed to the original scale. It reflects the relative geometric mean fold-change in hsCRP from baseline for CVC compared to placebo.|Evaluates whether CVC, compared to placebo, changes levels of hsCRP adjusting for statin-use.||1.52|0.62|0.91
72618140|NCT03572218|144767587|SUPERIORITY||Mean Difference (Net)|0.8|STANDARD_ERROR_OF_MEAN|1.6||0.64|TWO_SIDED||||||Mixed Models Analysis|||Diastolic Blood Pressure||||0.64
72618141|NCT03572218|144767588|SUPERIORITY||Mean Difference (Net)|0.1|STANDARD_ERROR_OF_MEAN|0.2||0.58|TWO_SIDED||||||Mixed Models Analysis|||Full Scale||||0.58
72618142|NCT03572218|144767588|SUPERIORITY||Mean Difference (Net)|0.1|STANDARD_ERROR_OF_MEAN|0.2||0.49|TWO_SIDED||||||Mixed Models Analysis|||Negative Affect||||0.49
72618143|NCT03572218|144767588|SUPERIORITY||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|0.1||0.96|TWO_SIDED||||||Mixed Models Analysis|||Maladaptive Eating||||0.96
72618144|NCT03572218|144767588|SUPERIORITY||Mean Difference (Net)|0.2|STANDARD_ERROR_OF_MEAN|0.3||0.71|TWO_SIDED||||||Mixed Models Analysis|||Healthy Lifestyle||||0.71
72618145|NCT03572218|144767588|SUPERIORITY||Mean Difference (Net)|-0.3|STANDARD_ERROR_OF_MEAN|0.3||0.41|TWO_SIDED||||||Mixed Models Analysis|||Exercise Avoidance||||0.41
72618146|NCT03572218|144767589|SUPERIORITY||Mean Difference (Net)|0.1|STANDARD_ERROR_OF_MEAN|0.2||0.61|TWO_SIDED||||||Mixed Models Analysis|||Full Scale||||0.61
72432398|NCT02696785|144377184|SUPERIORITY||LSMean Difference|-8.08|STANDARD_ERROR_OF_MEAN|1.603|<|0.001|TWO_SIDED|95.0|-11.2|-4.9|||ANCOVA|||||-4.9|-11.2|<0.001
72618147|NCT03572218|144767589|SUPERIORITY||Mean Difference (Net)|-0.1|STANDARD_ERROR_OF_MEAN|0.2||0.73|TWO_SIDED||||||Mixed Models Analysis|||Negative Affect||||0.73
72618148|NCT03572218|144767589|SUPERIORITY||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|0.1||0.94|TWO_SIDED||||||Mixed Models Analysis|||Maladaptive Eating||||0.94
72618149|NCT03572218|144767589|SUPERIORITY||Mean Difference (Net)|-0.2|STANDARD_ERROR_OF_MEAN|0.3||0.47|TWO_SIDED||||||Mixed Models Analysis|||Healthy Lifestyle||||0.47
72618150|NCT03572218|144767589|SUPERIORITY||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|0.3||0.99|TWO_SIDED||||||Mixed Models Analysis|||Exercise Avoidance||||0.99
72618151|NCT03572218|144767590|SUPERIORITY||Mean Difference (Net)|0.3|STANDARD_ERROR_OF_MEAN|0.2||0.13|TWO_SIDED||||||Mixed Models Analysis|||||||0.13
72618152|NCT03572218|144767591|SUPERIORITY||Mean Difference (Net)|0.3|STANDARD_ERROR_OF_MEAN|0.2||0.13|TWO_SIDED||||||Mixed Models Analysis|||||||0.13
72618153|NCT03572218|144767592|SUPERIORITY||Mean Difference (Net)|0.1|STANDARD_ERROR_OF_MEAN|0.1||0.53|TWO_SIDED||||||Mixed Models Analysis|||||||0.53
72618154|NCT03572218|144767593|SUPERIORITY||Mean Difference (Net)|0.2|STANDARD_ERROR_OF_MEAN|0.2||0.24|TWO_SIDED||||||Mixed Models Analysis|||||||0.24
72618155|NCT03572218|144767594|SUPERIORITY||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|0.2||0.83|TWO_SIDED||||||Mixed Models Analysis|||Global||||0.83
72555222|NCT05630885|144642137|SUPERIORITY||Slope|1.01||||0.94|TWO_SIDED|95.0|0.77|1.33||A-priori threshold for statistical significance is at p \< 0.05. No adjustments for multiple comparisons were done.|Regression, Linear|Outcome was log10-transformed. Model adjusted for statin-use.|Estimate obtained from regression on log10-transformed scale was back-transformed to the original scale. It reflects the relative geometric mean fold-change in IL-6 from baseline for CVC compared to placebo.|Evaluates whether CVC, compared to placebo, changes the levels of IL-6 adjusted for statin-use.||1.33|0.77|0.94
72555223|NCT05630885|144642137|SUPERIORITY||Slope|4.74|||<|0.001|TWO_SIDED|95.0|3.89|5.77||A-priori threshold for statistical significance is at p \< 0.05. No adjustments for multiple comparisons were done.|Regression, Linear|Outcome was log10-transformed. Model adjusted for statin-use.|Estimate obtained from regression on log10-transformed scale was back-transformed to the original scale. It reflects the relative geometric mean fold-change in MCP-1 from baseline for CVC compared to placebo.|Evaluates whether CVC, compared to placebo, changes the levels of MCP-1 adjusting for statin-use.||5.77|3.89|<0.001
72555224|NCT05630885|144642138|SUPERIORITY||Slope|-49.0||||0.38|TWO_SIDED|95.0|-158.0|60.0||A-priori threshold for statistical significance is at p \< 0.05. No adjustments for multiple comparisons were done.|Regression, Linear|Model adjusted for statin-use.|Estimate reflects the relative mean change in sCD14 from baseline for CVC compared to placebo.|Evaluates whether CVC, compared to placebo, changes levels of sCD14 adjusting for statin-use.||60|-158|0.38
72555225|NCT05630885|144642138|SUPERIORITY||Slope|-6.3||||0.88|TWO_SIDED|95.0|-87.0|75.0||A-priori threshold for statistical significance is at p \< 0.05. No adjustments for multiple comparisons were done.|Regression, Linear|Model adjusted for statin-use.|Estimate reflects the relative mean change in sCD163 from baseline for CVC compared to placebo.|Evaluates whether CVC, compared to placebo, changes the levels of sCD163 adjusting for statin-use.||75|-87|0.88
72555226|NCT05630885|144642139|SUPERIORITY||Slope|1.65|||<|0.001|TWO_SIDED|95.0|1.28|2.12||A-priori threshold for statistical significance is at p \< 0.05. No adjustments for multiple comparisons were done.|Regression, Linear|Outcome was log10-transformed. Model adjusted for statin-use.|Estimate obtained from regression on log10-transformed scale was back-transformed to the original scale. It reflects the relative geometric mean fold-change in MIP-1 beta from baseline for CVC compared to placebo.|Evaluates whether CVC, compared to placebo, changes the levels of MIP-1 beta adjusting for statin-use.||2.12|1.28|<0.001
72555227|NCT05630885|144642139|SUPERIORITY||Slope|1.02||||0.85|TWO_SIDED|95.0|0.82|1.28||A-priori threshold for statistical significance is at p \< 0.05. No adjustments for multiple comparisons were done.|Regression, Linear|Outcome was log10-transformed. Model adjusted for statin-use.|Estimate obtained from regression on log10-transformed scale was back-transformed to the original scale. It reflects the relative geometric mean fold-change in RANTES from baseline for CVC compared to placebo.|Evaluates whether CVC, compared to placebo, changes levels of RANTES adjusting for statin-use.||1.28|0.82|0.85
72555228|NCT03466866|144642167|SUPERIORITY||Incidence rate ratio|0.67||||0.12|TWO_SIDED|95.0|0.42|1.07|||Poisson regression|We adjusted for stratification variables, sex, baseline MOCA, number of medical conditions, PSQ Communication, and PSQ General satisfaction.||We used Poisson regression to model the number of outcome events as a function of randomization assignment, adjusting for the stratification variables and using follow-up time as the offset term. We calculated estimates of annual rates of the primary outcome and the adjusted estimate of the rate ratio. We evaluated the primary hypothesis by testing the null hypothesis that the rate ratio for randomization assignment equals 1.||1.07|.42|.12
72555229|NCT03466866|144642168|SUPERIORITY|General Satisfaction|Mean Difference (Final Values)|0.11||||0.502|TWO_SIDED|95.0|-0.22|0.45|||Regression, Linear|||We modeled PSQ- scores as continuous variables to estimate average change over time by treatment group. We used mixed effects linear regression with fixed effects for time (baseline, and months 6 and 12), randomization assignment, and time by randomization interaction. A random intercept term and an appropriate covariance structure was used to account for correlation among repeated measurements.||.45|-.22|.502
72555230|NCT03466866|144642169|SUPERIORITY||Mean Difference (Final Values)|0.26||||0.23|TWO_SIDED|95.0|0.16|0.69|||ANCOVA|||Analysis of covariance was performed with Number of Quality Metrics as the dependent variable, treatment arm as the main independent variable of interest and the stratification variables as adjusting variables.||.69|.16|.23
72555231|NCT03466866|144642170|SUPERIORITY||Mean Difference (Net)|4.45||||0.094|TWO_SIDED|95.0|-0.76|9.66|||Mixed Models Analysis|||We used mixed effects linear regression. Fixed effects included time (baseline, and months 6 and 12), randomization assignment, time by randomization interaction, and the three stratification variables. From the results of this model, we estimated the mean change from baseline to 6 months, 6 months to 12 months and baseline to 12 months within each treatment group. We then compared the change from baseline to 12 months between the two groups.||9.66|-.76|.094
72555232|NCT00318461|144642191|NON_INFERIORITY_OR_EQUIVALENCE|"Hypothesis testing was done in a hierarchical manner. First, it was tested whether liraglutide 1.8 mg+metformin was superior to placebo + metformin.~Superiority was always concluded if the upper limit of the 2-sided 95% CI for the treatment difference was below 0%."|Estimated treatment difference, LS Mean|-1.09|||<|0.0001||95.0|-1.3|-0.88|||ANCOVA|||Change in HbA1c from baseline to end of treatment at 26 weeks was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline glycosylated A1c (HbA1c) as covariate.||-0.88|-1.30|<0.0001
72555233|NCT00318461|144642191|NON_INFERIORITY_OR_EQUIVALENCE|Hypothesis testing was done in a hierarchical manner. As superiority of liraglutide 1.8 mg + metformin to metformin monotherapy was established, it was investigated whether liraglutide 1.8 mg + metformin was non-inferior to glimepiride + metformin. Non-inferiority was concluded if the upper limit of the 2-sided 95% CI for the treatment difference was below 0.4%.|Estimated treatment difference, LS Mean|-0.02|||<|0.0001||95.0|-0.19|0.15|||ANCOVA|||Change in HbA1c from baseline to end of treatment at 26 weeks was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline glycosylated A1c (HbA1c) as covariate.||0.15|-0.19|<0.0001
72555234|NCT00318461|144642191|NON_INFERIORITY_OR_EQUIVALENCE|Hypothesis testing was done in a hierarchical manner. First, it was tested whether liraglutide 1.2 mg+metformin was superior to placebo + metformin. Superiority was always concluded if the upper limit of the 2-sided 95% CI for the treatment difference was below 0%.|Estimated treatment difference, LS Mean|-1.06|||<|0.0001||95.0|-1.27|-0.85|||ANCOVA|||Change in HbA1c from baseline to end of treatment at 26 weeks was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline glycosylated A1c (HbA1c) as covariate.||-0.85|-1.27|<0.0001
72555235|NCT00318461|144642191|NON_INFERIORITY_OR_EQUIVALENCE|Hypothesis testing was done in a hierarchical manner. As superiority of liraglutide 1.2 mg + metformin to metformin monotherapy was established, it was investigated whether liraglutide 1.2 mg + metformin was non-inferior to glimepiride + metformin. Non-inferiority was concluded if the upper limit of the 2-sided 95% CI for the treatment difference was below 0.4%.|Estimated treatment difference, LS Mean|0.01|||<|0.0001||95.0|-0.16|0.18|||ANCOVA|||Change in HbA1c from baseline to end of treatment at 26 weeks was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline glycosylated A1c (HbA1c) as covariate.||0.18|-0.16|<0.0001
72555236|NCT00318461|144642191|NON_INFERIORITY_OR_EQUIVALENCE|Hypothesis testing was done in a hierarchical manner. First, it was tested whether liraglutide 0.6 mg+metformin was superior to placebo + metformin. Superiority was always concluded if the upper limit of the 2-sided 95% CI for the treatment difference was below 0%.|Estimated treatment difference, LS Mean|-0.78|||<|0.0001||95.0|-0.99|-0.57|||ANCOVA|||Change in HbA1c from baseline to end of treatment at 26 weeks was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline glycosylated A1c (HbA1c) as covariate.||-0.57|-0.99|<0.0001
72555237|NCT00318461|144642191|NON_INFERIORITY_OR_EQUIVALENCE|Hypothesis testing was done in a hierarchical manner. As superiority of liraglutide 0.6 mg + metformin to metformin monotherapy was established, it was investigated whether liraglutide 0.6 mg + metformin was non-inferior to glimepiride + metformin. Non-inferiority was concluded if the upper limit of the 2-sided 95% CI for the treatment difference was below 0.4%.|Estimated treatment difference, LS Mean|0.29||||0.1026||95.0|0.12|0.46|||ANCOVA|||Change in HbA1c from baseline to end of treatment at 26 weeks was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline glycosylated A1c (HbA1c) as covariate.||0.46|0.12|0.1026
72555238|NCT00318461|144642191|NON_INFERIORITY_OR_EQUIVALENCE|A test for superiority of glimepiride+metformin to metformin was performed to verify assay sensitivity. Superiority was always concluded if the upper limit of the 2-sided 95% CI for the treatment difference was below 0%.|Estimated treatment difference, LS Mean|-1.07|||<|0.0001||95.0|-1.28|-0.86|||ANCOVA|||Change in HbA1c from baseline to end of treatment at 26 weeks was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline glycosylated A1c (HbA1c) as covariate.||-0.86|-1.28|<0.0001
72555239|NCT00318461|144642192|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg + metformin and placebo + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|-1.29||||0.0016||95.0|-2.16|-0.41|||ANCOVA|||Change in body weight from baseline to end of treatment at 26 weeks was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline body weight as covariate.||-0.41|-2.16|0.0016
72555240|NCT00318461|144642192|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg + metformin and glimepiride + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|-3.75|||<|0.0001||95.0|-4.48|-3.01|||ANCOVA|||Change in body weight from baseline to end of treatment at 26 weeks was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline body weight as covariate.||-3.01|-4.48|<0.0001
72555241|NCT00318461|144642192|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.2 mg + metformin and placebo + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|-1.07||||0.0117||95.0|-1.94|-0.19|||ANCOVA|||Change in body weight from baseline to end of treatment at 26 weeks was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline body weight as covariate.||-0.19|-1.94|0.0117
72555242|NCT00318461|144642192|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.2 mg + metformin and glimepirde + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|-3.53|||<|0.0001||95.0|-4.27|-2.79|||ANCOVA|||Change in body weight from baseline to end of treatment at 26 weeks was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline body weight as covariate.||-2.79|-4.27|<0.0001
72555243|NCT00318461|144642192|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 0.6 mg + metformin and placebo + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|-0.28||||0.8198||95.0|-1.15|0.6|||ANCOVA|||Change in body weight from baseline to end of treatment at 26 weeks was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline body weight as covariate.||0.60|-1.15|0.8198
72618156|NCT03572218|144767594|SUPERIORITY||Mean Difference (Net)|0.1|STANDARD_ERROR_OF_MEAN|0.3||0.69|TWO_SIDED||||||Mixed Models Analysis|||Eating Restraint||||0.69
72618157|NCT03572218|144767594|SUPERIORITY||Mean Difference (Net)|0.3|STANDARD_ERROR_OF_MEAN|0.3||0.3|TWO_SIDED||||||Mixed Models Analysis|||Eating Concern||||0.30
72618158|NCT03572218|144767594|SUPERIORITY||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|0.3||0.99|TWO_SIDED||||||Mixed Models Analysis|||Weight Concern||||0.99
72555244|NCT00318461|144642192|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 0.6 mg + metformin and glimepirde + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|-2.73|||<|0.0001||95.0|-3.47|-2.0|||ANCOVA|||Change in body weight from baseline to end of treatment at 26 weeks was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline body weight as covariate.||-2.00|-3.47|<0.0001
72555245|NCT00318461|144642193|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg + metformin and placebo + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|-1.11||||0.0378||95.0|-2.18|-0.05|||ANCOVA|||Change in body weight from baseline to end of treatment at 104 weeks was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline body weight as covariate.||-0.05|-2.18|0.0378
72555246|NCT00318461|144642193|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg + metformin and glimepiride + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|-3.61|||<|0.0001||95.0|-4.51|-2.72|||ANCOVA|||Change in body weight from baseline to end of treatment at 104 weeks was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline body weight as covariate.||-2.72|-4.51|<0.0001
72555247|NCT00318461|144642193|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.2 mg + metformin and placebo + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|-1.23||||0.0185||95.0|-2.3|-0.16|||ANCOVA|||Change in body weight from baseline to end of treatment at 104 weeks was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline body weight as covariate.||-0.16|-2.30|0.0185
72555248|NCT00318461|144642193|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.2 mg + metformin and glimepirde + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|-3.73|||<|0.0001||95.0|-4.64|-2.83|||ANCOVA|||Change in body weight from baseline to end of treatment at 104 weeks was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline body weight as covariate.||-2.83|-4.64|<0.0001
72555249|NCT00318461|144642193|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 0.6 mg + metformin and placebo + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|-0.27||||0.9069||95.0|-1.33|0.8|||ANCOVA|||Change in body weight from baseline to end of treatment at 104 weeks was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline body weight as covariate.||0.80|-1.33|0.9069
72555250|NCT00318461|144642193|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 0.6 mg + metformin and glimepirde + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|-2.77|||<|0.0001||95.0|-3.67|-1.87|||ANCOVA|||Change in body weight from baseline to end of treatment at 104 weeks was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline body weight as covariate.||-1.87|-3.67|<0.0001
72555251|NCT00318461|144642194|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg + metformin and placebo + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|-2.09|||<|0.0001||95.0|-2.68|-1.5|||ANCOVA|||Change in fasting plasma glucose from baseline to end of treatment at 26 weeks was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline fasting plasma glucose as covariate.||-1.50|-2.68|<0.0001
72618159|NCT03572218|144767594|SUPERIORITY||Mean Difference (Net)|-0.3|STANDARD_ERROR_OF_MEAN|0.3||0.36|TWO_SIDED||||||Mixed Models Analysis|||Shape Concern||||0.36
72618160|NCT03572218|144767595|SUPERIORITY||Mean Difference (Net)|-0.2|STANDARD_ERROR_OF_MEAN|0.2||0.3|TWO_SIDED||||||Mixed Models Analysis|||Global||||0.30
72618161|NCT03572218|144767595|SUPERIORITY||Mean Difference (Net)|0.1|STANDARD_ERROR_OF_MEAN|0.3||0.69|TWO_SIDED||||||Mixed Models Analysis|||Eating Restraint||||0.69
72618162|NCT03572218|144767595|SUPERIORITY||Mean Difference (Net)|0.1|STANDARD_ERROR_OF_MEAN|0.3||0.7|TWO_SIDED||||||Mixed Models Analysis|||Eating Concern||||0.70
72618163|NCT03572218|144767595|SUPERIORITY||Mean Difference (Net)|-0.4|STANDARD_ERROR_OF_MEAN|0.3||0.26|TWO_SIDED||||||Mixed Models Analysis|||Weight Concern||||0.26
72618164|NCT03572218|144767595|SUPERIORITY||Mean Difference (Net)|-0.4|STANDARD_ERROR_OF_MEAN|0.3||0.18|TWO_SIDED||||||Mixed Models Analysis|||Shape Concern||||0.18
72618165|NCT03572218|144767596|SUPERIORITY||Mean Difference (Net)|0.4|STANDARD_ERROR_OF_MEAN|1.0||0.69|TWO_SIDED||||||Mixed Models Analysis|||Dietary Restraint||||0.69
72618166|NCT03572218|144767596|SUPERIORITY||Mean Difference (Net)|0.9|STANDARD_ERROR_OF_MEAN|0.8||0.28|TWO_SIDED||||||Mixed Models Analysis|||Disinhibition||||0.28
72618167|NCT03572218|144767596|SUPERIORITY||Mean Difference (Net)|-1.8|STANDARD_ERROR_OF_MEAN|0.8||0.02|TWO_SIDED||||||Mixed Models Analysis|||Hunger||||0.02
72618168|NCT03572218|144767597|SUPERIORITY||Mean Difference (Net)|1.2|STANDARD_ERROR_OF_MEAN|1.1||0.29|TWO_SIDED||||||Mixed Models Analysis|||Dietary Restraint||||0.29
72618169|NCT03572218|144767597|SUPERIORITY||Mean Difference (Net)|-0.8|STANDARD_ERROR_OF_MEAN|0.8||0.34|TWO_SIDED||||||Mixed Models Analysis|||Disinhibition||||0.34
72618170|NCT03572218|144767597|SUPERIORITY||Mean Difference (Net)|-2.5|STANDARD_ERROR_OF_MEAN|0.8||0.001|TWO_SIDED||||||Mixed Models Analysis|||Hunger||||0.001
72618171|NCT03572218|144767598|SUPERIORITY||Mean Difference (Net)|-1.1|STANDARD_ERROR_OF_MEAN|1.1||0.32|TWO_SIDED||||||Mixed Models Analysis|||||||0.32
72618172|NCT03572218|144767599|SUPERIORITY||Mean Difference (Net)|-0.8|STANDARD_ERROR_OF_MEAN|1.2||0.16|TWO_SIDED||||||Mixed Models Analysis|||||||0.16
72618173|NCT03572218|144767600|SUPERIORITY||Mean Difference (Net)|2.6|STANDARD_ERROR_OF_MEAN|4.8||0.59|TWO_SIDED||||||Mixed Models Analysis|||||||0.59
72618174|NCT03572218|144767601|SUPERIORITY||Mean Difference (Net)|-10.2|STANDARD_ERROR_OF_MEAN|13.1||0.44|TWO_SIDED||||||Mixed Models Analysis|||||||0.44
72493575|NCT00511355|144516366|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0041||95.0||||No correction for multiple testing was made.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for age class applied on the changes from baseline.||P-value compares the change from baseline to Cycle 6 between treatment groups.||||0.0041
72493576|NCT00511355|144516367|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9662||95.0||||No correction for multiple testing was made.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for age class applied on the changes from baseline.||P-value compares the change from baseline to Cycle 6 between treatment groups.||||0.9662
72493577|NCT00511355|144516368|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0004||95.0||||No correction for multiple testing was made.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for age class applied on the changes from baseline.||P-value compares the change from baseline to Cycle 6 between treatment groups.||||0.0004
72493578|NCT00511355|144516369|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0019||95.0||||No correction for multiple testing was made.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for age class applied on the changes from baseline.||P-value compares the change from baseline to Cycle 6 between treatment groups.||||0.0019
72493579|NCT00511355|144516370|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9662||95.0||||No correction for multiple testing was made.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for age class applied on the changes from baseline.||P-value compares the change from baseline to Cycle 6 between treatment groups.||||0.9662
72493580|NCT00511355|144516371|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0187||95.0||||No correction for multiple testing was made.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for age class applied on the changes from baseline.||P-value compares the change from baseline to Cycle 6 between treatment groups.||||0.0187
72493581|NCT00511355|144516372|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0||||No correction for multiple testing was made.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for age class applied on the changes from baseline.||P-value compares the change from baseline to Cycle 6 between treatment groups.||||<.0001
72493582|NCT00511355|144516373|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6886||95.0||||No correction for multiple testing was made.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for age class applied on the changes from baseline.||P-value compares the change from baseline to Cycle 6 between treatment groups.||||0.6886
72618175|NCT03572218|144767602|SUPERIORITY||Mean Difference (Net)|-0.2|STANDARD_ERROR_OF_MEAN|0.3||0.46|TWO_SIDED||||||Mixed Models Analysis|||Self-Reported Weighing||||0.46
72618176|NCT03572218|144767602|SUPERIORITY||Mean Difference (Net)|0.7|STANDARD_ERROR_OF_MEAN|0.4||0.12|TWO_SIDED||||||Mixed Models Analysis|||Track Food/Drink||||0.12
72618177|NCT03572218|144767602|SUPERIORITY||Mean Difference (Net)|0.3|STANDARD_ERROR_OF_MEAN|0.4||0.42|TWO_SIDED||||||Mixed Models Analysis|||Track Calories||||0.42
72618178|NCT03572218|144767602|SUPERIORITY||Mean Difference (Net)|0.8|STANDARD_ERROR_OF_MEAN|0.4||0.03|TWO_SIDED||||||Mixed Models Analysis|||Track Activity||||0.03
72618179|NCT03572218|144767603|SUPERIORITY||Mean Difference (Net)|0.4|STANDARD_ERROR_OF_MEAN|0.3||0.23|TWO_SIDED||||||Mixed Models Analysis|||Self-Reported Weighing||||0.23
72618180|NCT03572218|144767603|SUPERIORITY||Mean Difference (Net)|0.1|STANDARD_ERROR_OF_MEAN|0.4||0.9|TWO_SIDED||||||Mixed Models Analysis|||Track Food/Drink||||0.90
72618181|NCT03572218|144767603|SUPERIORITY||Mean Difference (Net)|0.3|STANDARD_ERROR_OF_MEAN|0.5||0.36|TWO_SIDED||||||Mixed Models Analysis|||Track Calories||||0.36
72618182|NCT03572218|144767603|SUPERIORITY||Mean Difference (Net)|0.5|STANDARD_ERROR_OF_MEAN|0.4||0.29|TWO_SIDED||||||Mixed Models Analysis|||Track Activity||||0.29
72618183|NCT03572218|144767604|SUPERIORITY||Mean Difference (Net)|-0.3|STANDARD_ERROR_OF_MEAN|0.3||0.25|TWO_SIDED||||||Mixed Models Analysis|||||||0.25
72618184|NCT03572218|144767605|SUPERIORITY||Mean Difference (Net)|-2.5|STANDARD_ERROR_OF_MEAN|2.2||0.27|TWO_SIDED||||||Mixed Models Analysis|||WSSQ-Total||||0.27
72618185|NCT03572218|144767605|SUPERIORITY||Mean Difference (Net)|-1.8|STANDARD_ERROR_OF_MEAN|1.2||0.13|TWO_SIDED||||||Mixed Models Analysis|||WSSQ-SD||||0.13
72618186|NCT03572218|144767605|SUPERIORITY||Mean Difference (Net)|0.6|STANDARD_ERROR_OF_MEAN|1.4||0.65|TWO_SIDED||||||Mixed Models Analysis|||WSSQ-FNE||||0.65
72618187|NCT03572218|144767606|SUPERIORITY||Mean Difference (Net)|-0.2|STANDARD_ERROR_OF_MEAN|0.2||0.21|TWO_SIDED||||||Mixed Models Analysis|||||||0.21
72618188|NCT03572218|144767607|SUPERIORITY||Mean Difference (Net)|-0.5|STANDARD_ERROR_OF_MEAN|1.2||0.7|TWO_SIDED||||||Mixed Models Analysis|||||||0.7
72618189|NCT03572218|144767608|SUPERIORITY||Mean Difference (Net)|-2.3|STANDARD_ERROR_OF_MEAN|1.8||0.2|TWO_SIDED||||||Mixed Models Analysis|||||||0.2
72618190|NCT03572218|144767609|SUPERIORITY||Mean Difference (Net)|3.7|STANDARD_ERROR_OF_MEAN|6.9||0.59|TWO_SIDED||||||Mixed Models Analysis|||||||0.59
72618191|NCT03572218|144767610|SUPERIORITY||Mean Difference (Net)|0.9|STANDARD_ERROR_OF_MEAN|3.5||0.81|TWO_SIDED||||||Mixed Models Analysis|||Total||||0.81
72618192|NCT03572218|144767610|SUPERIORITY||Mean Difference (Net)|0.8|STANDARD_ERROR_OF_MEAN|4.4||0.86|TWO_SIDED||||||Mixed Models Analysis|||Physical Function||||0.86
72618193|NCT03572218|144767610|SUPERIORITY||Mean Difference (Net)|1.2|STANDARD_ERROR_OF_MEAN|7.0||0.87|TWO_SIDED||||||Mixed Models Analysis|||Self Esteem||||0.87
72618194|NCT03572218|144767610|SUPERIORITY||Mean Difference (Net)|1.8|STANDARD_ERROR_OF_MEAN|5.2||0.73|TWO_SIDED||||||Mixed Models Analysis|||Sexual Life||||0.73
72618195|NCT03572218|144767610|SUPERIORITY||Mean Difference (Net)|0.3|STANDARD_ERROR_OF_MEAN|4.4||0.95|TWO_SIDED||||||Mixed Models Analysis|||Work||||0.95
72371766|NCT00669409|144253477|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-7.8|STANDARD_ERROR_OF_MEAN|7.73|||TWO_SIDED|95.0|-23.1|7.4||||||Change at Week 2, Pain: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||7.4|-23.1|
72493583|NCT00511355|144516374|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0||||No correction for multiple testing was made.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for age class applied on the changes from baseline.||P-value compares the change from baseline to Cycle 6 between treatment groups.||||<.0001
72371767|NCT00669409|144253477|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-3.0|STANDARD_ERROR_OF_MEAN|10.25|||TWO_SIDED|95.0|-23.3|17.2||||||Change at Week 2, Pain: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||17.2|-23.3|
72371768|NCT00669409|144253477|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|0.7|STANDARD_ERROR_OF_MEAN|7.89|||TWO_SIDED|95.0|-14.9|16.3||||||Change at Week 2, Physical functions: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||16.3|-14.9|
72371769|NCT00669409|144253477|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-9.9|STANDARD_ERROR_OF_MEAN|7.89|||TWO_SIDED|95.0|-25.5|5.7||||||Change at Week 2, Physical functions: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||5.7|-25.5|
72618196|NCT03572218|144767610|SUPERIORITY||Mean Difference (Net)|5.0|STANDARD_ERROR_OF_MEAN|3.8||0.19|TWO_SIDED||||||Mixed Models Analysis|||Public Distress||||0.19
72618197|NCT03572218|144767611|SUPERIORITY||Mean Difference (Net)|7.3|STANDARD_ERROR_OF_MEAN|4.9||0.14|TWO_SIDED||||||Mixed Models Analysis|||||||0.14
72618198|NCT03572218|144767612|SUPERIORITY||Mean Difference (Net)|0.9|STANDARD_ERROR_OF_MEAN|1.5||0.53|TWO_SIDED||||||Mixed Models Analysis|||||||0.53
72618199|NCT03572218|144767613|SUPERIORITY||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|1.5||0.99|TWO_SIDED||||||Mixed Models Analysis|||||||0.99
72618200|NCT03572218|144767614|SUPERIORITY||Mean Difference (Net)|-1.4|STANDARD_ERROR_OF_MEAN|3.6||0.71|TWO_SIDED||||||Mixed Models Analysis|||Systolic Blood Pressure||||0.71
72618201|NCT03572218|144767614|SUPERIORITY||Mean Difference (Net)|0.7|STANDARD_ERROR_OF_MEAN|1.9||0.72|TWO_SIDED||||||Mixed Models Analysis|||Diastolic Blood Pressure||||0.72
72618202|NCT03572218|144767615|SUPERIORITY||Mean Difference (Net)|0.4|STANDARD_ERROR_OF_MEAN|0.2||0.07|TWO_SIDED||||||Mixed Models Analysis|||||||0.07
72618203|NCT03572218|144767616|SUPERIORITY||Mean Difference (Net)|-0.1|STANDARD_ERROR_OF_MEAN|0.2||0.52|TWO_SIDED||||||Mixed Models Analysis|||Full Scale||||0.52
72618204|NCT03572218|144767616|SUPERIORITY||Mean Difference (Net)|-0.5|STANDARD_ERROR_OF_MEAN|0.2||0.02|TWO_SIDED||||||Mixed Models Analysis|||Negative Affect||||0.02
72618205|NCT03572218|144767616|SUPERIORITY||Mean Difference (Net)|-0.1|STANDARD_ERROR_OF_MEAN|0.2||0.63|TWO_SIDED||||||Mixed Models Analysis|||Maladaptive Eating||||0.63
72618206|NCT03572218|144767616|SUPERIORITY||Mean Difference (Net)|-0.1|STANDARD_ERROR_OF_MEAN|0.4||0.74|TWO_SIDED||||||Mixed Models Analysis|||Exercise Avoidance||||0.74
72618207|NCT03572218|144767616|SUPERIORITY||Mean Difference (Net)|-0.2|STANDARD_ERROR_OF_MEAN|0.3||0.49|TWO_SIDED||||||Mixed Models Analysis|||Healthy Lifestyle||||0.49
72618208|NCT03572218|144767617|SUPERIORITY||Mean Difference (Net)|0.2|STANDARD_ERROR_OF_MEAN|0.2||0.33|TWO_SIDED||||||Mixed Models Analysis|||||||0.33
72618209|NCT03572218|144767618|SUPERIORITY||Mean Difference (Net)|-1.2|STANDARD_ERROR_OF_MEAN|1.2||0.11|TWO_SIDED||||||Mixed Models Analysis|||||||0.11
72618210|NCT03572218|144767619|SUPERIORITY||Mean Difference (Net)|-0.2|STANDARD_ERROR_OF_MEAN|0.2||0.35|TWO_SIDED||||||Mixed Models Analysis|||Global||||0.35
72618211|NCT03572218|144767619|SUPERIORITY||Mean Difference (Net)|0.3|STANDARD_ERROR_OF_MEAN|0.4||0.46|TWO_SIDED||||||Mixed Models Analysis|||Eating Restraint||||0.46
72618212|NCT03572218|144767619|SUPERIORITY||Mean Difference (Net)|-0.3|STANDARD_ERROR_OF_MEAN|0.3||0.33|TWO_SIDED||||||Mixed Models Analysis|||Eating Concern||||0.33
72618213|NCT03572218|144767619|SUPERIORITY||Mean Difference (Net)|-0.4|STANDARD_ERROR_OF_MEAN|0.3||0.18|TWO_SIDED||||||Mixed Models Analysis|||Weight Concern||||0.18
72618214|NCT03572218|144767619|SUPERIORITY||Mean Difference (Net)|-0.5|STANDARD_ERROR_OF_MEAN|0.3||0.16|TWO_SIDED||||||Mixed Models Analysis|||Shape Concern||||0.16
72618215|NCT03572218|144767620|SUPERIORITY||Mean Difference (Net)|0.3|STANDARD_ERROR_OF_MEAN|1.3||0.82|TWO_SIDED||||||Mixed Models Analysis|||Dietary Restraint||||0.82
72618216|NCT03572218|144767620|SUPERIORITY||Mean Difference (Net)|-0.6|STANDARD_ERROR_OF_MEAN|0.8||0.45|TWO_SIDED||||||Mixed Models Analysis|||Disinhibition||||0.45
72618217|NCT03572218|144767620|SUPERIORITY||Mean Difference (Net)|-2.2|STANDARD_ERROR_OF_MEAN|0.8||0.007|TWO_SIDED||||||Mixed Models Analysis|||Hunger||||0.007
72618218|NCT03572218|144767621|SUPERIORITY||Mean Difference (Net)|0.4|STANDARD_ERROR_OF_MEAN|0.3||0.23|TWO_SIDED||||||Mixed Models Analysis|||Self-Reported Weighing||||0.23
72618219|NCT03572218|144767621|SUPERIORITY||Mean Difference (Net)|0.1|STANDARD_ERROR_OF_MEAN|0.3||0.48|TWO_SIDED||||||Mixed Models Analysis|||Track Food/Drink||||0.48
72618220|NCT03572218|144767621|SUPERIORITY||Mean Difference (Net)|-0.2|STANDARD_ERROR_OF_MEAN|0.4||0.89|TWO_SIDED||||||Mixed Models Analysis|||Track Calories||||0.89
72618221|NCT03572218|144767621|SUPERIORITY||Mean Difference (Net)|0.4|STANDARD_ERROR_OF_MEAN|0.5||0.3|TWO_SIDED||||||Mixed Models Analysis|||Track Activity||||0.30
72618222|NCT03572218|144767622|SUPERIORITY|||||||0.32|||||||ANOVA|||BWL component||||0.32
72618223|NCT03572218|144767623|SUPERIORITY|||||||0.14|||||||ANOVA|||||||0.14
72618224|NCT00286455|144767624|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.54|||<|0.001|TWO_SIDED|95.0|-0.76|-0.31||A step-down strategy was used for the primary analysis. First, the 25mg dose was compared to placebo at the 2-sided 0.05 significance level. The 12.5 mg dose was compared to placebo only if the comparison of the 25mg dose to placebo was significant.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint (HbA1c) as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|Null Hypothesis: No difference between treatment and placebo arms in change from baseline in glycosylated hemoglobin. Sample size calculated based on normally distributed means. For comparison of either dose vs. placebo (2-sample t-test), study sample size \>=325 subjects had 95% power to detect a treatment difference as small as 0.5% in the supportive per protocol analysis set assuming SD=0.8%, 2-sided \>0.05 significance level and \>=80% of subjects meeting per protocol criteria.||-0.31|-0.76|<0.001
72371770|NCT00669409|144253477|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|12.5|STANDARD_ERROR_OF_MEAN|8.06|||TWO_SIDED|95.0|-3.4|28.5||||||Change at Week 2, Physical functions: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||28.5|-3.4|
72622312|NCT04250207|144774537|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.||||||0.0051|||||||Chi-square or Fisher exact|||Week 24||||0.0051
72622313|NCT04250207|144774537|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.||||||0.1313|||||||Chi-square or Fisher exact|||Week 24||||0.1313
72622314|NCT04250207|144774537|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.||||||0.0268|||||||Chi-square or Fisher exact|||Week 38||||0.0268
72622315|NCT04250207|144774537|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.||||||0.3652|||||||Chi-square or Fisher exact|||Week 38||||0.3652
72622316|NCT04250207|144774537|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.||||||0.1854|||||||Chi-square or Fisher exact|||Week 52||||0.1854
72622317|NCT04250207|144774537|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.|||||>|0.9999|||||||Chi-square or Fisher exact|||Week 52||||> 0.9999
72622318|NCT04250207|144774538|SUPERIORITY|||||||0.0259|||||||Wilcoxon Rank Sum Test|||||||0.0259
72622319|NCT04250207|144774538|SUPERIORITY|||||||0.0068|||||||Wilcoxon Rank Sum Test|||||||0.0068
72622320|NCT04250207|144774539|SUPERIORITY|||||||0.4435|||||||Wilcoxon Rank Sum Test|||Week 1||||0.4435
72622321|NCT04250207|144774539|SUPERIORITY|||||||0.3402|||||||Wilcoxon Rank Sum Test|||Week 1||||0.3402
72622322|NCT04250207|144774539|SUPERIORITY||||||>|0.9999|||||||Wilcoxon Rank Sum Test|||Week 2||||> 0.9999
72622323|NCT04250207|144774539|SUPERIORITY|||||||0.0655|||||||Wilcoxon Rank Sum Test|||Week 3||||0.0655
72622324|NCT04250207|144774539|SUPERIORITY|||||||0.0903|||||||Wilcoxon Rank Sum Test|||Week 3||||0.0903
72622325|NCT04250207|144774539|SUPERIORITY|||||||0.0216|||||||Wilcoxon Rank Sum Test|||Week 5||||0.0216
72622326|NCT04250207|144774539|SUPERIORITY|||||||0.002|||||||Wilcoxon Rank Sum Test|||Week 5||||0.0020
72622327|NCT04250207|144774539|SUPERIORITY|||||||0.0676|||||||Wilcoxon Rank Sum Test|||Week 7||||0.0676
72622328|NCT04250207|144774539|SUPERIORITY|||||||0.0029|||||||Wilcoxon Rank Sum Test|||Week 7||||0.0029
72622329|NCT04250207|144774539|SUPERIORITY|||||||0.0335|||||||Wilcoxon Rank Sum Test|||Week 9||||0.0335
72622330|NCT04250207|144774539|SUPERIORITY|||||||0.0053|||||||Wilcoxon Rank Sum Test|||Week 9||||0.0053
72622331|NCT04250207|144774539|SUPERIORITY|||||||0.0608|||||||Wilcoxon Rank Sum Test|||Week 12||||0.0608
72622332|NCT04250207|144774539|SUPERIORITY|||||||0.0071|||||||Wilcoxon Rank Sum Test|||Week 12||||0.0071
72622333|NCT04250207|144774539|SUPERIORITY|||||||0.4406|||||||Wilcoxon Rank Sum Test|||Week 16||||0.4406
72622334|NCT04250207|144774539|SUPERIORITY|||||||0.1716|||||||Wilcoxon Rank Sum Test|||Week 16||||0.1716
72622335|NCT04250207|144774539|SUPERIORITY|||||||0.9856|||||||Wilcoxon Rank Sum Test|||Week 20||||0.9856
72622336|NCT04250207|144774539|SUPERIORITY|||||||0.2229|||||||Wilcoxon Rank Sum Test|||Week 20||||0.2229
72622337|NCT04250207|144774539|SUPERIORITY|||||||0.8817|||||||Wilcoxon Rank Sum Test|||Week 24||||0.8817
72622338|NCT04250207|144774539|SUPERIORITY|||||||0.2081|||||||Wilcoxon Rank Sum Test|||||||0.2081
72622339|NCT04250207|144774539|SUPERIORITY|||||||0.7335|||||||Wilcoxon Rank Sum Test|||Week 38||||0.7335
72622340|NCT04250207|144774539|SUPERIORITY|||||||0.5367|||||||Wilcoxon Rank Sum Test|||Week 38||||0.5367
72622341|NCT04250207|144774539|SUPERIORITY|||||||0.555|||||||Wilcoxon Rank Sum Test|||Week 52||||0.5550
72622342|NCT04250207|144774539|SUPERIORITY|||||||0.8718|||||||Wilcoxon Rank Sum Test|||Week 52||||0.8718
72622343|NCT03654326|144774544|SUPERIORITY||Difference in Least Squares Mean|-0.5||||0.066|TWO_SIDED|95.0|-1.01|0.03||Based on the longitudinal analysis of covariance (ANCOVA) model including factors for average pelvic pain scores at baseline cycle, stratum, treatment, cycle, interaction of stratum-by-cycle, and the interaction of treatment-by-cycle as covariates|ANCOVA|||||0.03|-1.01|0.066
72622344|NCT03654326|144774545|OTHER|Difference in percentage of participants who experienced one or more adverse events|Difference in % vs Placebo|17.7|||||TWO_SIDED|95.0|3.4|31.3|||||Based on Miettinen \& Nurminen method|||31.3|3.4|
72622345|NCT03654326|144774546|OTHER|Difference in percentage of participants who discontinued study drug due to an adverse event|Difference in % vs Placebo|3.2|||||TWO_SIDED|95.0|-0.9|9.0|||||Based on Miettinen \& Nurminen method|||9.0|-0.9|
72618225|NCT00286455|144767624|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.57|||<|0.001|TWO_SIDED|95.0|-0.8|-0.35|||ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint (HbA1c) as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|Null Hypothesis: No difference between treatment and placebo arms in change from baseline in glycosylated hemoglobin. Sample size calculated based on normally distributed means. For comparison of either dose vs. placebo (2-sample t-test), study sample size \>=325 subjects had 95% power to detect a treatment difference as small as 0.5% in the supportive per protocol analysis set assuming SD=0.8%, 2-sided \>0.05 significance level and \>=80% of subjects meeting per protocol criteria.||-0.35|-0.80|<0.001
72618226|NCT00286455|144767625|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.26|||<|0.001|TWO_SIDED|95.0|-0.39|-0.14||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.14|-0.39|<0.001
72618227|NCT00286455|144767625|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.34|||<|0.001|TWO_SIDED|95.0|-0.46|-0.21||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.21|-0.46|<0.001
72618228|NCT00286455|144767626|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|||<|0.001|TWO_SIDED|95.0|-0.57|-0.23||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.23|-0.57|<0.001
72618229|NCT00286455|144767626|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.51|||<|0.001|TWO_SIDED|95.0|-0.68|-0.33||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.33|-0.68|<0.001
72618230|NCT00286455|144767627|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.44|||<|0.001|TWO_SIDED|95.0|-0.63|-0.25||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.25|-0.63|<0.001
72618231|NCT00286455|144767627|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.54|||<|0.001|TWO_SIDED|95.0|-0.73|-0.35||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.35|-0.73|<0.001
72618232|NCT00286455|144767628|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.47|||<|0.001|TWO_SIDED|95.0|-0.68|-0.27||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.27|-0.68|<0.001
72618233|NCT00286455|144767628|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.54|||<|0.001|TWO_SIDED|95.0|-0.74|-0.33||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.33|-0.74|<0.001
72618234|NCT00286455|144767629|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.45|||<|0.001|TWO_SIDED|95.0|-0.67|-0.24||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.24|-0.67|<0.001
72618235|NCT00286455|144767629|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.48|||<|0.001|TWO_SIDED|95.0|-0.7|-0.27||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.27|-0.70|<0.001
72618236|NCT00286455|144767630|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.2||||0.002|TWO_SIDED|95.0|-21.5|-5.0||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-5.0|-21.5|0.002
72618237|NCT00286455|144767630|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-18.7|||<|0.001|TWO_SIDED|95.0|-27.0|-10.4||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-10.4|-27.0|<0.001
72618238|NCT00286455|144767631|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-18.4|||<|0.001|TWO_SIDED|95.0|-26.7|-10.1||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-10.1|-26.7|<0.001
72618239|NCT00286455|144767631|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-21.4|||<|0.001|TWO_SIDED|95.0|-29.7|-13.0||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-13.0|-29.7|<0.001
72618240|NCT00286455|144767632|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-18.4|||<|0.001|TWO_SIDED|95.0|-27.1|-9.7||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-9.7|-27.1|<0.001
72618241|NCT00286455|144767632|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-24.4|||<|0.001|TWO_SIDED|95.0|-33.2|-15.7||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-15.7|-33.2|<0.001
72618242|NCT00286455|144767633|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.7||||0.001|TWO_SIDED|95.0|-26.8|-6.7||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-6.7|-26.8|0.001
72618243|NCT00286455|144767633|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-22.3|||<|0.001|TWO_SIDED|95.0|-32.4|-12.2||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-12.2|-32.4|<0.001
72618244|NCT00286455|144767634|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.5||||0.002|TWO_SIDED|95.0|-26.8|-6.2||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-6.2|-26.8|0.002
72618245|NCT00286455|144767634|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-21.2|||<|0.001|TWO_SIDED|95.0|-31.6|-10.8||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-10.8|-31.6|<0.001
72618246|NCT00286455|144767635|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.8|||<|0.001|TWO_SIDED|95.0|-30.9|-8.7||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-8.7|-30.9|<0.001
72618247|NCT00286455|144767635|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-23.4|||<|0.001|TWO_SIDED|95.0|-34.6|-12.2||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-12.2|-34.6|<0.001
72618248|NCT00286455|144767636|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.3|||<|0.001|TWO_SIDED|95.0|-30.6|-8.0||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-8.0|-30.6|<0.001
72618249|NCT00286455|144767636|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-24.3|||<|0.001|TWO_SIDED|95.0|-35.7|-12.9||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-12.9|-35.7|<0.001
72618250|NCT00286455|144767637|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-21.6|||<|0.001|TWO_SIDED|95.0|-34.1|-9.0||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-9.0|-34.1|<0.001
72618251|NCT00286455|144767637|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-27.8|||<|0.001|TWO_SIDED|95.0|-40.4|-15.1||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-15.1|-40.4|<0.001
72618252|NCT00286455|144767638|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.569||||0.165|TWO_SIDED|95.0|0.257|1.262|||Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, diabetes duration and baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||1.262|0.257|0.165
72618253|NCT00286455|144767638|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.32||||0.008|TWO_SIDED|95.0|0.138|0.739|||Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, diabetes duration and baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||0.739|0.138|0.008
72371771|NCT00669409|144253477|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-6.5|STANDARD_ERROR_OF_MEAN|7.83|||TWO_SIDED|95.0|-21.9|9.0||||||Change at Week 2, Physical functions: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||9.0|-21.9|
72371772|NCT00669409|144253477|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-4.9|STANDARD_ERROR_OF_MEAN|10.3|||TWO_SIDED|95.0|-25.2|15.5||||||Change at Week 2, Physical functions: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||15.5|-25.2|
72493584|NCT00511355|144516375|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0||||No correction for multiple testing was made.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for age class applied on the changes from baseline.||P-value compares the change from baseline to Cycle 6 between treatment groups.||||<.0001
72371773|NCT00669409|144253477|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-5.0|STANDARD_ERROR_OF_MEAN|8.34|||TWO_SIDED|95.0|-21.4|11.5||||||Change at Week 2, Stiffness: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||11.5|-21.4|
72618254|NCT00286455|144767639|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.194||||0.001|TWO_SIDED|95.0|0.073|0.516|||Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, diabetes duration and baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||0.516|0.073|0.001
72618255|NCT00286455|144767639|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.145|||<|0.001|TWO_SIDED|95.0|0.052|0.405|||Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, diabetes duration and baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||0.405|0.052|<0.001
72618256|NCT00286455|144767640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.6||||0.056|TWO_SIDED|95.0|-15.3|0.2||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.2|-15.3|0.056
72618257|NCT00286455|144767640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.3|||<|0.001|TWO_SIDED|95.0|-21.1|-5.5||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-5.5|-21.1|<0.001
72618258|NCT00286455|144767641|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.8||||0.85|TWO_SIDED|95.0|-7.8|9.4||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||9.4|-7.8|0.850
72618259|NCT00286455|144767641|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.5||||0.571|TWO_SIDED|95.0|-6.2|11.2||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||11.2|-6.2|0.571
72618260|NCT00286455|144767642|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4||||0.917|TWO_SIDED|95.0|-7.8|7.0||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||7.0|-7.8|0.917
72618261|NCT00286455|144767642|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.7||||0.133|TWO_SIDED|95.0|-13.2|1.7||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||1.7|-13.2|0.133
72618262|NCT00286455|144767643|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.9||||0.348|TWO_SIDED|95.0|-12.1|4.3||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||4.3|-12.1|0.348
72618263|NCT00286455|144767643|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.0||||0.152|TWO_SIDED|95.0|-14.3|2.2||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||2.2|-14.3|0.152
72618264|NCT00286455|144767644|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.2||||0.12|TWO_SIDED|95.0|-11.7|1.4||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||1.4|-11.7|0.120
72618265|NCT00286455|144767644|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.5||||0.104|TWO_SIDED|95.0|-12.1|1.1||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||1.1|-12.1|0.104
72618266|NCT00286455|144767645|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.0||||0.247|TWO_SIDED|95.0|-10.9|2.8||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||2.8|-10.9|0.247
72618267|NCT00286455|144767645|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.4||||0.129|TWO_SIDED|95.0|-12.3|1.6||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||1.6|-12.3|0.129
72618268|NCT00286455|144767646|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.73||||0.671|TWO_SIDED|95.0|-4.14|2.67||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||2.67|-4.14|0.671
72371774|NCT00669409|144253477|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-13.8|STANDARD_ERROR_OF_MEAN|8.34|||TWO_SIDED|95.0|-30.3|2.7||||||Change at Week 2, Stiffness: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||2.7|-30.3|
72371775|NCT00669409|144253477|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|16.1|STANDARD_ERROR_OF_MEAN|8.45|||TWO_SIDED|95.0|-0.6|32.7||||||Change at Week 2, Stiffness: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||32.7|-0.6|
72371776|NCT00669409|144253477|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-6.7|STANDARD_ERROR_OF_MEAN|8.22|||TWO_SIDED|95.0|-22.9|9.5||||||Change at Week 2, Stiffness: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||9.5|-22.9|
72371777|NCT00669409|144253477|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-4.0|STANDARD_ERROR_OF_MEAN|10.86|||TWO_SIDED|95.0|-25.5|17.4||||||Change at Week 2, Stiffness: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||17.4|-25.5|
72371778|NCT00669409|144253478|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-7.3|STANDARD_ERROR_OF_MEAN|7.86|||TWO_SIDED|95.0|-22.9|8.2||||||Change at Week 4, Pain: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||8.2|-22.9|
72371779|NCT00669409|144253478|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-18.9|STANDARD_ERROR_OF_MEAN|7.86|||TWO_SIDED|95.0|-34.4|-3.3||||||Change at Week 4, Pain: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-3.3|-34.4|
72371780|NCT00669409|144253478|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-9.6|STANDARD_ERROR_OF_MEAN|7.92|||TWO_SIDED|95.0|-25.2|6.1||||||Change at Week 4, Pain: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||6.1|-25.2|
72371781|NCT00669409|144253478|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-15.5|STANDARD_ERROR_OF_MEAN|7.73|||TWO_SIDED|95.0|-30.8|-0.2||||||Change at Week 4, Pain: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-0.2|-30.8|
72371782|NCT00669409|144253478|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-27.9|STANDARD_ERROR_OF_MEAN|10.25|||TWO_SIDED|95.0|-48.1|-7.6||||||Change at Week 4, Pain: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-7.6|-48.1|
72371783|NCT00669409|144253478|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-5.7|STANDARD_ERROR_OF_MEAN|7.89|||TWO_SIDED|95.0|-21.3|9.9||||||Change at Week 4, Physical Functions: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||9.9|-21.3|
72371784|NCT00669409|144253478|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-17.0|STANDARD_ERROR_OF_MEAN|7.89|||TWO_SIDED|95.0|-32.6|-1.4||||||Change at Week 4, Physical Functions: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-1.4|-32.6|
72371785|NCT00669409|144253478|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-8.4|STANDARD_ERROR_OF_MEAN|8.06|||TWO_SIDED|95.0|-24.3|7.5||||||Change at Week 4, Physical Functions: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||7.5|-24.3|
72371786|NCT00669409|144253478|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-16.8|STANDARD_ERROR_OF_MEAN|7.83|||TWO_SIDED|95.0|-32.2|-1.3||||||Change at Week 4, Physical Functions: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-1.3|-32.2|
72371787|NCT00669409|144253478|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-27.5|STANDARD_ERROR_OF_MEAN|10.3|||TWO_SIDED|95.0|-47.8|-7.1||||||Change at Week 4, Physical Functions: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-7.1|-47.8|
72371788|NCT00669409|144253478|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-9.0|STANDARD_ERROR_OF_MEAN|8.34|||TWO_SIDED|95.0|-25.5|7.4||||||Change at Week 4, Stiffness: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||7.4|-25.5|
72371789|NCT00669409|144253478|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-19.7|STANDARD_ERROR_OF_MEAN|8.34|||TWO_SIDED|95.0|-36.1|-3.2||||||Change at Week 4, Stiffness: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-3.2|-36.1|
72371790|NCT00669409|144253478|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-5.4|STANDARD_ERROR_OF_MEAN|8.45|||TWO_SIDED|95.0|-22.1|11.3||||||Change at Week 4, Stiffness: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||11.3|-22.1|
72371791|NCT00669409|144253478|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-14.7|STANDARD_ERROR_OF_MEAN|8.22|||TWO_SIDED|95.0|-30.9|1.6||||||Change at Week 4, Stiffness: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||1.6|-30.9|
72371792|NCT00669409|144253478|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-23.0|STANDARD_ERROR_OF_MEAN|10.86|||TWO_SIDED|95.0|-44.4|-1.5||||||Change at Week 4, Stiffness: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-1.5|-44.4|
72371793|NCT00669409|144253479|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|3.3|STANDARD_ERROR_OF_MEAN|7.86|||TWO_SIDED|95.0|-12.2|18.8||||||Change at Week 8, Pain: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||18.8|-12.2|
72371794|NCT00669409|144253479|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-11.4|STANDARD_ERROR_OF_MEAN|7.86|||TWO_SIDED|95.0|-27.0|4.1||||||Change at Week 8, Pain: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||4.1|-27.0|
72371795|NCT00669409|144253479|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-1.7|STANDARD_ERROR_OF_MEAN|7.92|||TWO_SIDED|95.0|-17.4|13.9||||||Change at Week 8, Pain: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||13.9|-17.4|
72371796|NCT00669409|144253479|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-9.5|STANDARD_ERROR_OF_MEAN|7.73|||TWO_SIDED|95.0|-24.8|5.8||||||Change at Week 8, Pain: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||5.8|-24.8|
72371797|NCT00669409|144253479|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-19.0|STANDARD_ERROR_OF_MEAN|10.25|||TWO_SIDED|95.0|-39.2|1.3||||||Change at Week 8, Pain: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||1.3|-39.2|
72371798|NCT00669409|144253479|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|5.0|STANDARD_ERROR_OF_MEAN|7.89|||TWO_SIDED|95.0|-10.6|20.6||||||Change at Week 8, Physical functions: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||20.6|-10.6|
72371799|NCT00669409|144253479|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-8.4|STANDARD_ERROR_OF_MEAN|7.89|||TWO_SIDED|95.0|-24.0|7.1||||||Change at Week 8, Physical functions: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||7.1|-24.0|
72371800|NCT00669409|144253479|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|8.06|||TWO_SIDED|95.0|-17.1|14.8||||||Change at Week 8, Physical functions: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||14.8|-17.1|
72371801|NCT00669409|144253479|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-9.2|STANDARD_ERROR_OF_MEAN|7.83|||TWO_SIDED|95.0|-24.6|6.3||||||Change at Week 8, Physical functions: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||6.3|-24.6|
72371802|NCT00669409|144253479|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-17.8|STANDARD_ERROR_OF_MEAN|10.3|||TWO_SIDED|95.0|-38.2|2.5||||||Change at Week 8, Physical functions: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||2.5|-38.2|
72371803|NCT00669409|144253479|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-1.8|STANDARD_ERROR_OF_MEAN|8.34|||TWO_SIDED|95.0|-18.3|14.6||||||Change at Week 8, Stiffness: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||14.6|-18.3|
72371804|NCT00669409|144253479|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-20.1|STANDARD_ERROR_OF_MEAN|8.34|||TWO_SIDED|95.0|-36.5|-3.6||||||Change at Week 8, Stiffness: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-3.6|-36.5|
72371805|NCT00669409|144253479|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-2.8|STANDARD_ERROR_OF_MEAN|8.45|||TWO_SIDED|95.0|-19.5|13.9||||||Change at Week 8, Stiffness: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||13.9|-19.5|
72371806|NCT00669409|144253479|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-10.9|STANDARD_ERROR_OF_MEAN|8.22|||TWO_SIDED|95.0|-27.1|5.4||||||Change at Week 8, Stiffness: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||5.4|-27.1|
72371807|NCT00669409|144253479|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-10.5|STANDARD_ERROR_OF_MEAN|10.86|||TWO_SIDED|95.0|-32.0|10.9||||||Change at Week 8, Stiffness: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||10.9|-32.0|
72371808|NCT00669409|144253480|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|13.0|STANDARD_ERROR_OF_MEAN|7.86|||TWO_SIDED|95.0|-2.5|28.6||||||Change at Week 13, Pain: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||28.6|-2.5|
72371809|NCT00669409|144253480|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-5.5|STANDARD_ERROR_OF_MEAN|7.86|||TWO_SIDED|95.0|-21.0|10.0||||||Change at Week 13, Pain: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||10.0|-21.0|
72371810|NCT00669409|144253480|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|5.3|STANDARD_ERROR_OF_MEAN|7.92|||TWO_SIDED|95.0|-10.4|20.9||||||Change at Week 13, Pain: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||20.9|-10.4|
72371811|NCT00669409|144253480|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-7.8|STANDARD_ERROR_OF_MEAN|7.73|||TWO_SIDED|95.0|-23.1|7.5||||||Change at Week 13, Pain: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||7.5|-23.1|
72371812|NCT00669409|144253480|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-9.5|STANDARD_ERROR_OF_MEAN|10.25|||TWO_SIDED|95.0|-29.7|10.8||||||Change at Week 13, Pain: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||10.8|-29.7|
72371813|NCT00669409|144253480|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|14.3|STANDARD_ERROR_OF_MEAN|7.89|||TWO_SIDED|95.0|-1.3|29.8||||||Change at Week 13, Physical Functions: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||29.8|-1.3|
72371814|NCT00669409|144253480|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-3.6|STANDARD_ERROR_OF_MEAN|7.89|||TWO_SIDED|95.0|-19.2|12.0||||||Change at Week 13, Physical Functions: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||12.0|-19.2|
72371815|NCT00669409|144253480|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|6.8|STANDARD_ERROR_OF_MEAN|8.06|||TWO_SIDED|95.0|-9.1|22.8||||||Change at Week 13, Physical Functions: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||22.8|-9.1|
72371816|NCT00669409|144253480|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-10.3|STANDARD_ERROR_OF_MEAN|7.83|||TWO_SIDED|95.0|-25.8|5.1||||||Change at Week 13, Physical Functions: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||5.1|-25.8|
72371817|NCT00669409|144253480|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-8.4|STANDARD_ERROR_OF_MEAN|10.3|||TWO_SIDED|95.0|-28.8|12.0||||||Change at Week 13, Physical Functions: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||12.0|-28.8|
72371818|NCT00669409|144253480|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|7.0|STANDARD_ERROR_OF_MEAN|8.34|||TWO_SIDED|95.0|-9.5|23.4||||||Change at Week 13, Stiffness: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||23.4|-9.5|
72371819|NCT00669409|144253480|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-5.9|STANDARD_ERROR_OF_MEAN|8.34|||TWO_SIDED|95.0|-22.4|10.6||||||Change at Week 13, Stiffness: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||10.6|-22.4|
72371820|NCT00669409|144253480|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|12.2|STANDARD_ERROR_OF_MEAN|8.45|||TWO_SIDED|95.0|-4.5|28.9||||||Change at Week 13, Stiffness: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||28.9|-4.5|
72371821|NCT00669409|144253480|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-9.0|STANDARD_ERROR_OF_MEAN|8.22|||TWO_SIDED|95.0|-25.2|7.2||||||Change at Week 13, Stiffness: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||7.2|-25.2|
72371822|NCT00669409|144253480|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|10.86|||TWO_SIDED|95.0|-22.4|20.5||||||Change at Week 13, Stiffness: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||20.5|-22.4|
72371823|NCT03583385|144253501|EQUIVALENCE|Bio-equivalence Analysis was performed with Equivalence Acceptance Range for 90% Confidence Interval (CI) as 80.00% - 125.00%.|% Ratio of Geometric Means|103.42|||||TWO_SIDED|90.0|95.18|112.37||||||||112.37|95.18|
72371824|NCT03583385|144253502|EQUIVALENCE|Bio-equivalence Analysis was performed with Equivalence Acceptance Range for 90% Confidence Interval (CI) as 80.00% - 125.00%.|% Ratio of Geometric Means|106.78|||||TWO_SIDED|90.0|98.99|115.19||||||||115.19|98.99|
72371825|NCT04780919|144253507|SUPERIORITY|||||||0.722||||||p-value is adjusted to comparison between the Group A and Group B at 3 weeks follow-up after the last application.|Two-way ANOVA|||The Group A will have significantly decreased Cross Section Area compared to Group B at 3 weeks follow up after last application.||||0.722
72371826|NCT04780919|144253508|SUPERIORITY|||||||0.096||||||p-value is adjusted to comparison between the Group A and Group B in the timeframe of the last application.|Two-way ANOVA|||The maximum pain will decrease significantly more in Group A compared to Group B in the timeframe of the last application compared to baseline.||||0.096
72618269|NCT00286455|144767646|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.15||||0.218|TWO_SIDED|95.0|-5.57|1.27||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||1.27|-5.57|0.218
72618270|NCT00286455|144767647|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.54||||0.403|TWO_SIDED|95.0|-2.07|5.14||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||5.14|-2.07|0.403
72618271|NCT00286455|144767647|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.29||||0.487|TWO_SIDED|95.0|-2.35|4.93||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||4.93|-2.35|0.487
72371827|NCT04780919|144253509|SUPERIORITY|||||||0.035||||||p-value is adjusted to comparison between the Group A and Group B at the 3 weeks follow up compared to baseline.|Two-way ANOVA|||The maximum pain will decrease significantly more in Group A compared to Group B at the 3 weeks follow up compared to baseline.||||0.035
72371828|NCT04780919|144253510|SUPERIORITY|||||||0.171||||||p-value is adjusted to comparison between the Group A and Group B at the 3 weeks follow up compared to baseline.|Two-way ANOVA|||The maximum of ankle dorsiflexion range of motion will increase significantly more in Group A compared to Group B at the 3 weeks follow up compared to baseline.||||0.171
72371829|NCT04780919|144253513|SUPERIORITY|||||||0.104||||||p-value is adjusted to comparison between the Group A and Group B in 3 weeks follow up after the last application.|Two-way ANOVA|||The VISA-A score will increase significantly more in Group A compared to Group B at the 3 weeks follow up compared to baseline.||||0.104
72618272|NCT00286455|144767648|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.6||||0.143|TWO_SIDED|95.0|-0.88|6.08||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||6.08|-0.88|0.143
72618273|NCT00286455|144767648|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.06||||0.974|TWO_SIDED|95.0|-3.46|3.57||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||3.57|-3.46|0.974
72618274|NCT00286455|144767649|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.97||||0.612|TWO_SIDED|95.0|-2.78|4.71||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||4.71|-2.78|0.612
72618275|NCT00286455|144767649|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.04||||0.587|TWO_SIDED|95.0|-4.82|2.74||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||2.74|-4.82|0.587
72618276|NCT00286455|144767650|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.0||||0.514|TWO_SIDED|95.0|-2.0|3.99||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||3.99|-2.00|0.514
72618277|NCT00286455|144767650|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2||||0.899|TWO_SIDED|95.0|-2.83|3.22||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||3.22|-2.83|0.899
72618278|NCT00286455|144767651|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.24||||0.885|TWO_SIDED|95.0|-3.09|3.58||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||3.58|-3.09|0.885
72618279|NCT00286455|144767651|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.09||||0.958|TWO_SIDED|95.0|-3.28|3.46||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||3.46|-3.28|0.958
72493585|NCT00511355|144516376|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0083||95.0||||No correction for multiple testing was made.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for age class applied on the changes from baseline.||P-value compares the change from baseline to Cycle 6 between treatment groups.||||0.0083
72618280|NCT00286455|144767652|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.051||||0.003|TWO_SIDED|95.0|-0.084|-0.018||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.018|-0.084|0.003
72618281|NCT00286455|144767652|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.072|||<|0.001|TWO_SIDED|95.0|-0.105|-0.038||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.038|-0.105|<0.001
72618282|NCT00286455|144767653|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.069|||<|0.001|TWO_SIDED|95.0|-0.099|-0.038||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.038|-0.099|<0.001
72618283|NCT00286455|144767653|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.052||||0.001|TWO_SIDED|95.0|-0.083|-0.021||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.021|-0.083|0.001
72618284|NCT00286455|144767654|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.068|||<|0.001|TWO_SIDED|95.0|-0.103|-0.032||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.032|-0.103|<0.001
72371830|NCT02191865|144253560|SUPERIORITY_OR_OTHER||ratio of the geometric means|215.39|STANDARD_DEVIATION|73.5|||TWO_SIDED|90.0|120.71|384.32|||ANOVA|Fixed effect: 'hepatic status'; indicated whether a subject with hepatic impairment or a healthy subject , Random effect: 'matched pair'.|Ratio of Child Pugh A (Test): Healthy Child Pugh A (Reference). The Standard deviation is the Intra-individual gCV|The statistical model used for the analysis of AUC (0-inf) was an ANOVA (analysis of variance) model on the logarithmic scale. Observations from a subject with hepatic impairment and the matched healthy control subject were analysed as a matched pair.||384.32|120.71|
72371831|NCT02191865|144253560|SUPERIORITY_OR_OTHER||Ratio of geometric means|867.13|STANDARD_DEVIATION|45.9|||TWO_SIDED|90.0|572.93|1312.41|||ANOVA|Fixed effect: 'hepatic status'; indicated whether a subject with hepatic impairment or a healthy subject , Random effect: 'matched pair'.|Ratio of Child Pugh B (Test): Healthy Child Pugh B (Reference). The Standard deviation is the Intra-individual gCV|The statistical model used for the analysis of AUC (0-inf) was an ANOVA (analysis of variance) model on the logarithmic scale. Observations from a subject with hepatic impairment and the matched healthy control subject were analysed as a matched pair.||1312.41|572.93|
72371832|NCT02191865|144253561|SUPERIORITY_OR_OTHER||ratio of the geometric means|221.76|STANDARD_DEVIATION|61.4|||TWO_SIDED|90.0|134.73|365.01|||ANOVA|Fixed effect: 'hepatic status'; indicated whether a subject with hepatic impairment or a healthy subject , Random effect: 'matched pair'.|Ratio of Child Pugh A (Test): Healthy Child Pugh A (Reference). The Standard deviation is the Intra-individual gCV|The statistical model used for the analysis of Cmax was an ANOVA (analysis of variance) model on the logarithmic scale. Observations from a subject with hepatic impairment and the matched healthy control subject were analysed as a matched pair.||365.01|134.73|
72371833|NCT02191865|144253561|SUPERIORITY_OR_OTHER||Ratio of geometric means|761.01|STANDARD_DEVIATION|69.1|||TWO_SIDED|90.0|439.01|1319.18|||ANOVA|Fixed effect: 'hepatic status'; indicated whether a subject with hepatic impairment or a healthy subject , Random effect: 'matched pair'.|Ratio of Child Pugh B (Test): Healthy Child Pugh B (Reference). The Standard deviation is the Intra-individual gCV|The statistical model used for the analysis of Cmax was an ANOVA (analysis of variance) model on the logarithmic scale. Observations from a subject with hepatic impairment and the matched healthy control subject were analysed as a matched pair.||1319.18|439.01|
72371834|NCT02191865|144253562|SUPERIORITY_OR_OTHER||ratio of the geometric means|216.79|STANDARD_DEVIATION|75.0|||TWO_SIDED|90.0|120.37|390.45|||ANOVA|Fixed effect: 'hepatic status'; indicated whether a subject with hepatic impairment or a healthy subject , Random effect: 'matched pair'.|Ratio of Child Pugh A (Test): Healthy Child Pugh A (Reference). The Standard deviation is the Intra-individual gCV|The statistical model used for the analysis of AUC (0-tz) was an ANOVA (analysis of variance) model on the logarithmic scale. Observations from a subject with hepatic impairment and the matched healthy control subject were analysed as a matched pair.||390.45|120.37|
72371835|NCT02191865|144253562|SUPERIORITY_OR_OTHER||Ratio of geometric means|870.74|STANDARD_DEVIATION|45.7|||TWO_SIDED|90.0|576.36|1315.49|||ANOVA|Fixed effect: 'hepatic status'; indicated whether a subject with hepatic impairment or a healthy subject , Random effect: 'matched pair'.|Ratio of Child Pugh B (Test): Healthy Child Pugh B (Reference). The Standard deviation is the Intra-individual gCV|The statistical model used for the analysis of AUC (0-tz) was an ANOVA (analysis of variance) model on the logarithmic scale. Observations from a subject with hepatic impairment and the matched healthy control subject were analysed as a matched pair.||1315.49|576.36|
72371836|NCT00621348|144253564|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence analysis|Risk Ratio (RR)|0.12|STANDARD_ERROR_OF_MEAN|0.0|<|0.05|TWO_SIDED|95.0|0.016|0.93||p value was adjusted for multiple comparisons.|Fisher Exact||The risk ratio is for Group A compared with Group C.|The incidence of hospital-acquired hyponatremia with current standard intravenous fluid therapy was approximately 30%. Sample of 72 patients would be needed in each group to demonstrate the decrease in incidence of hyponatremia (defined as plasma sodium\< 130 mEq/L) to 10%, with a power of 80 percent and alpha error of 0.05. In view of short study period and feasibility it was planned a priori to enroll at least 50 patients in each treatment limb.||0.93|0.016|<0.05
72371837|NCT00332722|144253640|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Paired t test|||||||<0.05
72371838|NCT00332722|144253641|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Paired t test|||||||<0.05
72371839|NCT00918736|144253646|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||t-test, 2 sided|||Previous report using 5 weekly injections, mean AOS score reduction is 2.6 with the SD of 1.8 in 75 patients. To test whether AOS reduction would be \> 1 using pair t-test after 3 weekly injections, investigators need \> 42 patients to give \> 90% power to reject the null hypothesis-mean AOS score reduction \<1 at 6 months, given that both the mean and standard deviation of AOS score reduction equal to 2. Considering possible dropout of participants, investigators decide to include 50 patients||||<0.05
72371840|NCT01474018|144253653|SUPERIORITY_OR_OTHER_LEGACY|||||||0.004|TWO_SIDED||||||ANOVA|||||||0.004
72371841|NCT01474018|144253654|SUPERIORITY_OR_OTHER_LEGACY|||||||0.01|TWO_SIDED||||||ANOVA|||||||0.01
72371842|NCT01474018|144253654|SUPERIORITY_OR_OTHER_LEGACY|||||||0.009|TWO_SIDED||||||ANOVA|||||||0.009
72371843|NCT02433080|144253656|OTHER||Mean Difference (Net)|6.4||||0.05|TWO_SIDED|95.0|-3.6|16.5|||ANCOVA|||This statistical analysis applies for the outcomes 2-8.||16.5|-3.6|0.05
72371844|NCT03462511|144253680|SUPERIORITY||Mean Difference (Net)|2.4||||0.067|TWO_SIDED|||||Independent variables: study month, study group, their interactions and a person-level random intercept to incorporate clustering.|Regression, Linear|||Based on estimated effect size from our prior feasibility trial, the target enrollment was 87 dyads plus additional 20% to account for attrition before Month 6 or blood transfusions or acute illness rendering HbF levels inaccurate.||||0.067
72371845|NCT03462511|144253681|SUPERIORITY|||||||0.6|||||||t-test, 2 sided|||We compared the difference in proportion of days covered by hydroxyurea at two timepoints: (1) from the year prior to study entry to 6 months (the end of the active intervention phase of the trial) and (2) from 6 months to 12 months (the sustainability phase of the trial).||||0.60
72371846|NCT03462511|144253682|SUPERIORITY||||||<|0.001|||||||Regression, Linear|||We hypothesized that, compared to the control group, generic quality of life (QOL) for youth in the intervention group would improve from baseline to 9 months.||||<0.001
72493586|NCT00511355|144516377|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0455||95.0||||No correction for multiple testing was made.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for age class applied on the changes from baseline.||P-value compares the change from baseline to Cycle 6 between treatment groups.||||0.0455
72371847|NCT03462511|144253682|NON_INFERIORITY|30% of the standard deviation was used as the non-inferiority margin. For this test generic quality of life (QOL) scores for months 4-9 (efficacy period) were compared to months \>9 (sustainability period).||||||0.04|||||||Regression, Linear|||We hypothesized that the improvement in quality of life experienced by the intervention group would be sustained from month 9 to month 12.||||0.04
72371848|NCT03462511|144253683|SUPERIORITY|||||||0.47|||||||Regression, Linear|||We hypothesized that, compared to the control group, sickle cell disease specific quality of life (SC-QOL) for youth in the intervention group would improve from baseline to 9 months.||||0.47
72371849|NCT03462511|144253683|NON_INFERIORITY|30% of the standard deviation was used as the non-inferiority margin. For this test sickle cell disease specific quality of life (SC-QOL) scores for months 4-9 (efficacy period) were compared to months \>9 (sustainability period).||||||0.045|||||||Regression, Linear|||We hypothesized that the improvement in sickle cell disease specific quality of life (SC-QOL) experienced by the intervention group would be sustained from month 9 to month 12.||||0.045
72371850|NCT03462511|144253684|SUPERIORITY|||||||0.002|||||||Regression, Linear|||We hypothesized that, compared to the control group, responsibility for self-management concordance for youth-caregiver dyads in the intervention group would improve from baseline to 6 months.||||0.002
72371851|NCT03462511|144253684|NON_INFERIORITY|50% of the standard deviation was used as the non-inferiority margin. For this test youth caregiver concordance for self-management responsibility scores for months 0-6 (efficacy period) were compared to months 6-12 (sustainability period).||||||0.23|||||||Regression, Linear|||We hypothesized that the improvement in concordance between youth and caregivers for self-management responsibility experienced by the intervention group would be sustained from month 6 to month 12.||||0.23
72371852|NCT03495856|144253708|OTHER|within-group paired t-test|Mean Difference (Final Values)|-0.77|STANDARD_ERROR_OF_MEAN|0.37||0.05|TWO_SIDED|95.0|-1.55|0.0||The a priori threshold for statistical significance was p less than or equal to 0.05. That calculated p-value in the statistical hypothesis test was equal to 0.05.|t-test, 2 sided|||||0.00|-1.55|0.05
72371853|NCT03495856|144253709|OTHER|within-group paired t-test|Mean Difference (Final Values)|-3.67|STANDARD_ERROR_OF_MEAN|1.42||0.017|TWO_SIDED|95.0|-6.63|-0.71|||t-test, 2 sided|||||-0.71|-6.63|0.017
72371854|NCT03495856|144253710|OTHER|Within-group paired t-test|Mean Difference (Final Values)|0.06|STANDARD_ERROR_OF_MEAN|0.7||0.938|TWO_SIDED|95.0|-1.39|1.5|||t-test, 2 sided|||||1.50|-1.39|0.938
72371855|NCT03495856|144253711|OTHER|Within-group paired t-test|Mean Difference (Final Values)|-3.34|STANDARD_ERROR_OF_MEAN|1.05||0.005|TWO_SIDED|95.0|-5.53|-1.15||The a priori threshold for statistical significance was p less than or equal to 0.05.|t-test, 2 sided|||||-1.15|-5.53|0.005
72371856|NCT03495856|144253712|OTHER|Within-group paired t-test|Mean Difference (Final Values)|-2.21|STANDARD_ERROR_OF_MEAN|1.38||0.124|TWO_SIDED|95.0|-5.09|0.66|||t-test, 2 sided|||||0.66|-5.09|0.124
72618285|NCT00286455|144767654|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.073|||<|0.001|TWO_SIDED|95.0|-0.109|-0.037||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.037|-0.109|<0.001
72371857|NCT03495856|144253713|OTHER|Within-group paired t-test|Mean Difference (Final Values)|-4.69|STANDARD_ERROR_OF_MEAN|1.26||0.001|TWO_SIDED|95.0|-7.3|-2.07|||t-test, 2 sided|||||-2.07|-7.30|0.001
72493587|NCT00511355|144516378|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0063||95.0||||No correction for multiple testing was made.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for age class applied on the changes from baseline.||P-value compares the change from baseline to Cycle 6 between treatment groups.||||0.0063
72371858|NCT03495856|144253714|OTHER|Within-group paired t-test|Mean Difference (Final Values)|-1.27|STANDARD_ERROR_OF_MEAN|0.5||0.018|TWO_SIDED|95.0|-2.31|-0.24|||t-test, 2 sided|||||-0.24|-2.31|0.018
72371859|NCT03495856|144253715|OTHER|Within-group paired t-test|Mean Difference (Final Values)|2.79|STANDARD_ERROR_OF_MEAN|1.07||0.016|TWO_SIDED|95.0|0.58|5.01|||t-test, 2 sided|||||5.01|0.58|0.016
72371860|NCT03495856|144253716|OTHER|Within-group paired t-test|Mean Difference (Final Values)|-4.96|STANDARD_ERROR_OF_MEAN|1.41||0.002|TWO_SIDED|95.0|-7.88|-2.03|||t-test, 2 sided|||||-2.03|-7.88|0.002
72371861|NCT03495856|144253717|OTHER|Within-group paired t-test|Mean Difference (Final Values)|13.27|STANDARD_ERROR_OF_MEAN|2.45|<|0.001|TWO_SIDED|95.0|8.47|18.07|||t-test, 2 sided|||||18.07|8.47|<0.001
72371862|NCT03495856|144253718|OTHER|Within-group paired t-test|Mean Difference (Final Values)|8.0|STANDARD_ERROR_OF_MEAN|1.96||0.001|TWO_SIDED|95.0|3.92|12.08|||t-test, 2 sided|||||12.08|3.92|0.001
72371863|NCT00435045|144253719|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority of the non-HDL-C response was assessed by calculating the 2-sided 90% and 95% confidence intervals (CIs)for each difference in response based on comparing the effects of increases in atorvastatin dose on the percent changes from baseline to the end of each atorvastatin period, a repeated-ANOVA model was used.||||||0.0002||95.0|||||ANOVA|||||||0.0002
72371864|NCT01015638|144253759|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Kruskal-Wallis|||||||>0.05
72371865|NCT01015638|144253760|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Dunn's Multiple Comparisons Test|||||||>0.05
72371866|NCT01015638|144253761|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Kruskal-Wallis|||||||>0.05
72371867|NCT01015638|144253762|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Tukey-Kramer Multiple Comparisons Test|||||||> 0.05
72371868|NCT00776919|144253797|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel|||||||<0.001
72371869|NCT00776919|144253797|SUPERIORITY_OR_OTHER|||||||0.016||95.0|||||Cochran-Mantel-Haenszel|||||||0.016
72371870|NCT00776919|144253797|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel|||||||<0.001
72371871|NCT00776919|144253798|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Based on an analysis of covariance (ANCOVA) with factors of treatment, center, and interaction of treatment-center. If the treatment-center interaction was not significant at the 0.1 level, this interaction was excluded from the ANCOVA model.|ANCOVA|||||||<0.001
72371872|NCT00776919|144253798|SUPERIORITY_OR_OTHER|||||||0.015||95.0||||Based on an analysis of covariance (ANCOVA) with factors of treatment, center, and interaction of treatment-center. If the treatment-center interaction was not significant at the 0.1 level, this interaction was excluded from the ANCOVA model.|ANCOVA|||||||0.015
72371873|NCT00776919|144253798|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Based on an analysis of covariance (ANCOVA) with factors of treatment, center, and interaction of treatment-center. If the treatment-center interaction was not significant at the 0.1 level, this interaction was excluded from the ANCOVA model.|ANCOVA|||||||<0.001
72371874|NCT00776919|144253799|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Based on an analysis of covariance (ANCOVA) with factors of treatment, center, and interaction of treatment-center. If the treatment-center interaction was not significant at the 0.1 level, this interaction was excluded from the ANCOVA model.|ANCOVA|||||||<0.001
72371875|NCT00776919|144253799|SUPERIORITY_OR_OTHER|||||||0.102||95.0||||Based on an analysis of covariance (ANCOVA) with factors of treatment, center, and interaction of treatment-center. If the treatment-center interaction was not significant at the 0.1 level, this interaction was excluded from the ANCOVA model.|ANCOVA|||||||0.102
72371876|NCT00776919|144253799|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Based on an analysis of covariance (ANCOVA) with factors of treatment, center, and interaction of treatment-center. If the treatment-center interaction was not significant at the 0.1 level, this interaction was excluded from the ANCOVA model.|ANCOVA|||||||<0.001
72371877|NCT00776919|144253800|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Based on an analysis of covariance (ANCOVA) with factors of treatment, center, and interaction of treatment-center. If the treatment-center interaction was not significant at the 0.1 level, this interaction was excluded from the ANCOVA model.|ANCOVA|||||||<0.001
72371878|NCT00776919|144253800|SUPERIORITY_OR_OTHER|||||||0.032||95.0||||Based on an analysis of covariance (ANCOVA) with factors of treatment, center, and interaction of treatment-center. If the treatment-center interaction was not significant at the 0.1 level, this interaction was excluded from the ANCOVA model.|ANCOVA|||||||0.032
72371879|NCT00776919|144253800|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Based on an analysis of covariance (ANCOVA) with factors of treatment, center, and interaction of treatment-center. If the treatment-center interaction was not significant at the 0.1 level, this interaction was excluded from the ANCOVA model.|ANCOVA|||||||<0.001
72371880|NCT00711477|144253814|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.7|||||TWO_SIDED|90.0|0.5|0.9||||||||0.90|0.50|
72371881|NCT00711477|144253815|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.56||||0.38|TWO_SIDED|95.0|-1.83|0.72|||ANCOVA|Type III sums of squares from ANCOVA model: Treatment and Baseline||||0.72|-1.83|0.380
72371882|NCT00711477|144253816|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.4||||0.744|TWO_SIDED|95.0|-2.87|2.07|||ANCOVA|Type III sums of squares from ANCOVA model: Treatment and Baseline||||2.07|-2.87|0.744
72371883|NCT00711477|144253817|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.64||||0.139|TWO_SIDED|95.0|-3.84|0.56|||ANCOVA|Type III sums of squares from ANCOVA model: Treatment and Baseline||||0.56|-3.84|0.139
72371884|NCT00711477|144253818|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.36||||0.094|TWO_SIDED|95.0|-2.96|0.24|||ANCOVA|Type III sums of squares from ANCOVA model: Treatment and Baseline||||0.24|-2.96|0.094
72371885|NCT00711477|144253819|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.48||||0.102|TWO_SIDED|95.0|-5.48|0.51|||ANCOVA|Type III sums of squares from ANCOVA model: Treatment and Baseline||||0.51|-5.48|0.102
72371886|NCT00711477|144253820|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-9.4||||0.16||95.0|-22.7|3.89|||ANCOVA|Type III sums of squares from ANCOVA model: Treatment and Baseline||||3.89|-22.7|0.160
72371887|NCT00711477|144253821|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.6|||||TWO_SIDED|90.0|0.4|0.8||||||||0.80|0.40|
72371888|NCT00711477|144253822|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.75|||||TWO_SIDED|90.0|0.5|1.0||||||||1.00|0.50|
72371889|NCT00711477|144253823|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.99|||||TWO_SIDED|90.0|0.74|1.24||||||||1.24|0.74|
72371890|NCT00711477|144253824|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.3|||||TWO_SIDED|90.0|0.95|1.65||||||||1.65|0.95|
72371891|NCT00711477|144253825|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.44|||||TWO_SIDED|90.0|0.31|0.57||||||||0.57|0.31|
72371892|NCT02878798|144253826|OTHER|Non-inferiority and superiority tests were completed|Slope|0.2105|||||ONE_SIDED|95.0|-0.4328||||||||||-0.4328|
72371893|NCT02878798|144253827|OTHER|Non-inferiority and superiority tests were done|Slope|-1.5219|||||ONE_SIDED|95.0||1.1933||||||||1.1933||
72371894|NCT02878798|144253828|SUPERIORITY||Slope|-0.02322|||||TWO_SIDED|95.0|-0.6337|0.5872|||Mixed Models Analysis|||||0.5872|-0.6337|
72371895|NCT02878798|144253829|SUPERIORITY||Slope|-0.168||||0.261|TWO_SIDED|95.0|-0.4612|0.1253|||Mixed Models Analysis|||||0.1253|-0.4612|0.261
72371896|NCT02878798|144253830|SUPERIORITY||Slope|-0.061||||0.9007|TWO_SIDED|95.0|-1.0213|0.8992|||Mixed Models Analysis|||||0.8992|-1.0213|0.9007
72371897|NCT02878798|144253831|SUPERIORITY||Slope|0.0106||||0.8174|TWO_SIDED|95.0|-0.0793|0.1005|||Hurdle model|||||0.1005|-0.0793|0.8174
72371898|NCT02878798|144253832|SUPERIORITY||Slope|-0.7394||||0.0233|TWO_SIDED|95.0|-1.3775|-0.1013|||Mixed Models Analysis|||||-0.1013|-1.3775|0.0233
72371899|NCT02878798|144253833|SUPERIORITY||Slope|-0.1328||||0.7586|TWO_SIDED|95.0|-0.982|0.7164|||Mixed Models Analysis|||||0.7164|-0.982|0.7586
72371900|NCT02878798|144253834|SUPERIORITY||Slope|-0.0021||||0.9604|TWO_SIDED|95.0|-0.084|0.0799|||Mixed Models Analysis|||||0.0799|-0.084|0.9604
72371901|NCT02878798|144253835|SUPERIORITY||Slope|-0.0396||||0.2365|TWO_SIDED|95.0|-0.1053|0.0261|||Mixed Models Analysis|||||0.0261|-0.1053|0.2365
72371902|NCT02878798|144253836|SUPERIORITY||Slope|2.3848||||0.5813|TWO_SIDED|95.0|-6.1336|10.9032|||Mixed Models Analysis|||||10.9032|-6.1336|0.5813
72371903|NCT02878798|144253837|SUPERIORITY||Slope|-1.0547||||0.4092|TWO_SIDED|95.0|-3.5705|1.4611|||Mixed Models Analysis|||||1.4611|-3.5705|0.4092
72371904|NCT00101452|144253840|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||ANOVA|||||||<0.05
72371905|NCT01014910|144253853|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05|TWO_SIDED|||||Based on a previously-identified mean LOS of 65.3 hours, we estimated we would need to enroll 80 patients in each study arm to provide adequate sample size to detect a difference in mean LOS of 18 hours with 80% power and alpha=0.05.|Wilcoxon (Mann-Whitney)|Sample size calculations were performed using Power and Sample Size Calculator, version 3.0 (by developers William D. Dupont and Walton D. Plummer Jr)||Differences in LOS were compared between study arms using the Mann-Whitney U-test and the Kaplan-Meier method. Statistical analyses were performed using Stata version 13.1 for Windows (StataCorp). All patients enrolled in the study, including those who subsequently had consent for the intervention withdrawn, were included for analysis (intention to treat).||||<0.05
72371906|NCT01014910|144253854|SUPERIORITY_OR_OTHER_LEGACY|||||||0.05|TWO_SIDED||||||Chi-squared, Corrected|||The proportion of patients transferred to the intensive care unit in each study arm was compared between study arms using the Pearson χ2 test. All patients enrolled in the study, including those who subsequently had consent for the intervention withdrawn, were included for analysis (intention to treat).||||0.05
72371907|NCT02055118|144253867|SUPERIORITY||Least squares mean|3.0|STANDARD_ERROR_OF_MEAN|5.12||0.5669|TWO_SIDED|95.0|-7.3|13.3|||Mixed model repeated measures|||The Mixed model repeated measures included fixed categorical effects for treatment, visit week, treatment by visit week interaction, baseline GCA classification factor (less than or equal to \[\<=\] 70 or \>70), baseline age group (\<6 years or \>=6 years), treatment by baseline GCA classification factor interaction, treatment by baseline age group interaction, interaction between baseline GCA classification factor and baseline age group, genotype, and the baseline GCA score as a continuous covariate.||13.3|-7.3|0.5669
72371908|NCT02259088|144253901|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|5.8|||<|0.001|TWO_SIDED|95.0|4.1|7.5|||Cochran-Mantel-Haenszel|One-sided p-value for treatment difference is derived from the two-sided stratified Cochran-Mantel-Haenszel test using the row means score statistics.|Estimated from ANOVA (stratified) model. Stratified analysis includes DME type (focal, diffuse, honeycomb and petaloid) and Baseline BCVA(≤ 60 letters and \> 60 letters) as factors.|||7.5|4.1|<0.001
72371909|NCT02872285|144253943|SUPERIORITY||Mean Difference (Final Values)|-12.8||||0.2205|TWO_SIDED|95.0|-33.793|8.199||ANCOVA was used to compare mean percent change in PASI score between baseline and Week 12 between LYC-30937 and placebo treatment groups with treatment as a factor and baseline as a covariate.|ANCOVA|||Subjects included in this analysis had to have both a baseline and Week 12 PASI scores.||8.199|-33.793|0.2205
72371910|NCT02872285|144253944|SUPERIORITY|||||||0.4712|||||||Chi-squared|2-sided p-value.||||||0.4712
72371911|NCT02872285|144253945|SUPERIORITY||Mean Difference (Final Values)|-5.34||||0.6695|TWO_SIDED|95.0|-30.87|20.18|||ANCOVA|||||20.18|-30.87|0.6695
72371912|NCT02872285|144253946|SUPERIORITY|||||||0.4712||||||2-sided p-value|Chi-squared|||||||0.4712
72371913|NCT02872285|144253947|SUPERIORITY|||||||0.4712||||||2-sided p-value|Chi-squared|||||||0.4712
72371914|NCT03425253|144253949|OTHER||||||<|0.001||||||P-value was based on paired t-test for the mean difference.|Paired t-test|||Investigator: Both Sides of Face, Last Treatment||||<0.001
72493588|NCT00511355|144516379|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0||||No correction for multiple testing was made.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for age class applied on the changes from baseline.||P-value compares the change from baseline to Cycle 6 between treatment groups.||||<.0001
72371915|NCT03425253|144253949|OTHER||||||<|0.001||||||P-value was based on paired t-test for the mean difference.|Paired t-test|||Investigator: Right Side of Face, Last Treatment||||<0.001
72371916|NCT03425253|144253949|OTHER||||||<|0.001||||||P-value was based on paired t-test for the mean difference.|Paired t-test|||Investigator: Left Side of Face, Last Treatment||||<0.001
72371917|NCT03425253|144253949|OTHER|||||||0.018||||||P-value was based on paired t-test for the mean difference.|Paired t-test|||Independent Reviewer: Both Sides of Face, Last Treatment||||0.018
72371918|NCT03425253|144253949|OTHER|||||||0.301||||||P-value was based on paired t-test for the mean difference.|Paired t-test|||Independent Reviewer: Right Side of Face, Last Treatment||||0.301
72371919|NCT03425253|144253949|OTHER|||||||0.011||||||P-value was based on paired t-test for the mean difference.|Paired t-test|||Independent Reviewer: Left Side of Face, Last Treatment||||0.011
72371920|NCT03425253|144253950|OTHER||||||<|0.001||||||P-value was based on paired t-test for the mean difference.|Paired t-test|||||||<0.001
72371921|NCT03425253|144253951|OTHER|||||||0.597||||||P-value was based on paired t-test for the mean difference.|Paired t-test|||||||0.597
72371922|NCT03425253|144253952|OTHER||||||<|0.001||||||P-value was based on paired t-test for the mean difference.|Paired t-test|||||||<0.001
72371923|NCT03425253|144253953|OTHER||||||<|0.001||||||P-value was based on paired t-test for the mean difference.|Paired t-test|||||||<0.001
72371924|NCT03425253|144253954|OTHER||||||<|0.001||||||P-value was based on paired t-test for the mean difference.|Paired t-test|||||||<0.001
72371925|NCT03425253|144253955|OTHER|||||||0.003||||||P-value was based on paired t-test for the mean difference.|Paired t-test|||||||0.003
72371926|NCT03425253|144253956|OTHER||||||<|0.001||||||P-value was based on paired t-test for the mean difference.|Paired t-test|||Both Side of the Face, End of Study||||<0.001
72371927|NCT03425253|144253956|OTHER||||||<|0.001||||||P-value was based on paired t-test for the mean difference.|Paired t-test|||Right Side of the Face, End of study||||<0.001
72371928|NCT03425253|144253956|OTHER||||||<|0.001||||||P-value was based on paired t-test for the mean difference.|Paired t-test|||Left Side of the Face, End of Study||||<0.001
72371929|NCT01523275|144253969|EQUIVALENCE|Analysis of 44 subjects (22 in each arm) would provide 90% power to detect a difference in the time interval to reoperation of 6 months between the two treatment arms, at an alpha level of 0.05. This difference of 6 months is clinically meaningful and is smaller than previous case series studies would suggest. However, due to poor patient accrual, the study was closed prior to reaching the desired study size.||||||0.95|||||||t-test, 2 sided|||||||0.95
72371930|NCT01523275|144253970|EQUIVALENCE|A difference of 6 months to symptom progression is clinically meaningful.||||||0.52|||||||t-test, 2 sided|||||||0.52
72371931|NCT01523275|144253971|EQUIVALENCE|0.5 liters per second is clinically significant.||||||0.64|||||||t-test, 2 sided|||||||0.64
72371932|NCT00689117|144253972|SUPERIORITY_OR_OTHER|||||||0.063||95.0||||Inflammatory lesion count|Ranked ANCOVA|||||||0.063
72371933|NCT00689117|144253972|SUPERIORITY_OR_OTHER|||||||0.003||95.0||||Inflammatory lesion count|Ranked ANCOVA|||||||0.003
72371934|NCT00689117|144253972|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Inflammatory lesion count|Ranked ANCOVA|||||||<0.001
72371935|NCT00689117|144253972|SUPERIORITY_OR_OTHER|||||||0.004||95.0||||Non-inflammatory lesion count|Ranked ANCOVA|||||||0.004
72371936|NCT00689117|144253972|SUPERIORITY_OR_OTHER|||||||0.55||95.0||||Non-inflammatory lesion count|Ranked ANCOVA|||||||0.550
72371937|NCT00689117|144253972|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Non-inflammatory lesion count|Ranked ANCOVA|||||||<0.001
72371938|NCT00689117|144253972|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Total lesion count|Ranked ANCOVA|||||||<0.001
72371939|NCT00689117|144253972|SUPERIORITY_OR_OTHER|||||||0.016||95.0||||Total lesion count|Ranked ANCOVA|||||||0.016
72371940|NCT00689117|144253972|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Total lesion count|Ranked ANCOVA|||||||<0.001
72371941|NCT00689117|144253973|SUPERIORITY_OR_OTHER|||||||0.001||95.0||||Data based on Data on File documenting FDA reanalysis request|Cochran-Mantel-Haenszel|||||||0.001
72371942|NCT00689117|144253973|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Data based on Data on File documenting FDA reanalysis request|Cochran-Mantel-Haenszel|||||||<0.001
72371943|NCT00689117|144253973|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Data based on Data on File documenting FDA reanalysis request|Cochran-Mantel-Haenszel|||||||<0.001
72618286|NCT00286455|144767655|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.045||||0.021|TWO_SIDED|95.0|-0.084|-0.007||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.007|-0.084|0.021
72618287|NCT00286455|144767655|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.04||||0.043|TWO_SIDED|95.0|-0.079|-0.001||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.001|-0.079|0.043
72618288|NCT00286455|144767656|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.162|||<|0.001|TWO_SIDED|95.0|-0.255|-0.069||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.069|-0.255|<0.001
72618289|NCT00286455|144767656|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.159||||0.001|TWO_SIDED|95.0|-0.254|-0.065||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.065|-0.254|0.001
72371944|NCT00689117|144253974|SUPERIORITY_OR_OTHER|||||||0.065||95.0||||Inflammatory lesion count|Ranked ANCOVA|||||||0.065
72371945|NCT00689117|144253974|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||Inflammatory lesion count|Ranked ANCOVA|||||||0.002
72371946|NCT00689117|144253974|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Inflammatory lesion count|Ranked ANCOVA|||||||<0.001
72371947|NCT00689117|144253974|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Non-inflammatory lesion count|Ranked ANCOVA|||||||<0.001
72618290|NCT00286455|144767657|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.086||||0.001|TWO_SIDED|95.0|-0.138|-0.034||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.034|-0.138|0.001
72371948|NCT00689117|144253974|SUPERIORITY_OR_OTHER|||||||0.284||95.0||||Non-inflammatory lesion count|Ranked ANCOVA|||||||0.284
72622346|NCT03654326|144774547|OTHER|The difference in least squares mean was based on the longitudinal analysis of covariance (ANCOVA) model including factors for average pelvic pain scores at baseline cycle, stratum, treatment, cycle, interaction of stratum-by-cycle, and the interaction of treatment-by-cycle as covariates|Difference in Least Squares Mean|-0.6|||||TWO_SIDED|95.0|-1.18|-0.06||||||||-0.06|-1.18|
72371949|NCT00689117|144253974|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Non-inflammatory lesion count|Ranked ANCOVA|||||||<0.001
72371950|NCT00689117|144253974|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Total lesion count|Ranked ANCOVA|||||||<0.001
72371951|NCT00689117|144253974|SUPERIORITY_OR_OTHER|||||||0.028||95.0||||Total lesion count|Ranked ANCOVA|||||||0.028
72371952|NCT00689117|144253974|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Total lesion count|Ranked ANCOVA|||||||<0.001
72371953|NCT00689117|144253975|SUPERIORITY_OR_OTHER|||||||0.671||95.0|||||Cochran-Mantel-Haenszel|||||||0.671
72371954|NCT00689117|144253975|SUPERIORITY_OR_OTHER|||||||0.919||95.0|||||Cochran-Mantel-Haenszel|||||||0.919
72371955|NCT00689117|144253975|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||Cochran-Mantel-Haenszel|||||||0.002
72371956|NCT00689117|144253976|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||Cochran-Mantel-Haenszel|||||||0.002
72371957|NCT00689117|144253976|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel|||||||<0.001
72371958|NCT00689117|144253976|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel|||||||<0.001
72371959|NCT05408637|144254000|OTHER|The small sample size did not allow for statistical tests. Therefore, we looked at overall patterns and calculated differences between stimulation (Active vs Sham).|Mean Difference (Final Values)|54.75|||||TWO_SIDED||||||||Difference = Active - Sham|||||
72371960|NCT05408637|144254000|OTHER||Percent Difference|0.85|||||TWO_SIDED||||||||Difference = Active - Sham|The small sample size did not allow for statistical tests. Therefore, we looked at percent difference between stimulation (Active vs Sham).||||
72371961|NCT05408637|144254000|OTHER||Cohen's d|0.07|||||TWO_SIDED|||||||||We evaluated the effect size of the difference between Active and Sham using Cohen's d.||||
72371962|NCT05408637|144254001|OTHER|The small sample size did not allow for statistical tests. Therefore, we looked at overall patterns and calculated differences between active stimulation timepoints (Day 1 vs Day 5).|Mean Difference (Final Values)|224.8392|||||TWO_SIDED||||||||Difference = Day 5 Active - Day 1 Active|||||
72371963|NCT05408637|144254001|OTHER||Percent Difference|4.35|||||TWO_SIDED||||||||Difference = Day 5 Active - Day 1 Active|The small sample size did not allow for statistical tests. Therefore, we calculated percent difference between active stimulation timepoints (Day 1 vs Day 5).||||
72371964|NCT05408637|144254001|OTHER||Cohen's d|0.36|||||TWO_SIDED|||||||||We evaluated the effect size of the difference between active stimulation timepoints (Day 1 vs Day 5) using Cohen's d.||||
72371965|NCT05408637|144254002|OTHER||rank biserial correlation coefficient|0.767||||0.15|TWO_SIDED||||||Wilcoxon signed rank test|||The Wilcoxon signed-rank test was used to evaluate changes in the IGT at Baseline vs Day 5 due to the small sample size and distributional assumptions. Effect sizes were calculated using the rank biserial correlation coefficient (r) to estimate the magnitude of change.||||0.15
72371966|NCT05408637|144254002|OTHER|The Friedman test was used to assess overall differences in IGT across Baseline, Day 1, and Day 5.||||||0.038|||||||Friedman test|||||||0.038
72371967|NCT05408637|144254002|OTHER|The Friedman test was used to assess overall differences in IGT across all timepoints (Baseline, Day 1, Day 5, Follow-Up).||||||0.043|||||||Friedman test|||||||0.043
72371968|NCT05408637|144254002|OTHER|The Wilcoxon signed-rank test was used to evaluate changes in the BIS across timepoints due to the small sample size and distributional assumptions. Effect sizes were calculated using the rank biserial correlation coefficient (r) to estimate the magnitude of change.|rank biserial correlation coefficient|0.134||||0.42|TWO_SIDED||||||Wilcoxon signed rank test|BIS across timepoints||||||0.42
72371969|NCT05408637|144254002|OTHER|The Wilcoxon signed-rank test was used to evaluate changes in the BRIEF-A across timepoints due to the small sample size and distributional assumptions.||||||0.232|||||||Wilcoxon signed rank test|BRIEF-A across timepoints||||||0.232
72371970|NCT05408637|144254002|OTHER|The Wilcoxon signed-rank test was used to evaluate changes in the i7 Impulsivity across timepoints due to the small sample size and distributional assumptions. Effect sizes were calculated using the rank biserial correlation coefficient (r) to estimate the magnitude of change.|rank biserial correlation coefficient|0.575||||0.06|TWO_SIDED||||||Wilcoxon signed rank test|i7 Impulsivity||||||0.06
72371971|NCT05408637|144254002|OTHER|The Wilcoxon signed-rank test was used to evaluate changes in the i7 Venturesomeness across timepoints due to the small sample size and distributional assumptions. Effect sizes were calculated using the rank biserial correlation coefficient (r) to estimate the magnitude of change.|rank biserial correlation coefficient|0.275||||0.36|TWO_SIDED||||||Wilcoxon signed rank test|||||||0.36
72371972|NCT05408637|144254003|OTHER|Non-parametric tests were employed to evaluate changes across MOODS-SR Baseline to Day 5 due to the small sample size and distributional assumptions. The Wilcoxon signed-rank tests were applied for pairwise comparisons. Effect sizes were calculated using Cohen's d to estimate the magnitude of change.|Cohen's d|0.12||||0.6|TWO_SIDED||||||Wilcoxon signed rank test|||||||0.6
72371973|NCT05408637|144254003|OTHER|Non-parametric tests were employed to evaluate changes across MOODS-SR Baseline to Follow Up due to the small sample size and distributional assumptions. The Wilcoxon signed-rank tests were applied for pairwise comparisons. Effect sizes were calculated using Cohen's d to estimate the magnitude of change.|Cohen's d|0.24||||0.2|TWO_SIDED||||||Wilcoxon signed rank test|||||||0.2
72371974|NCT05871450|144254004|SUPERIORITY|||||||0.05|||||||Regression, Linear|||||||0.05
72371975|NCT02693132|144254030|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<0.05
72371976|NCT02693132|144254031|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<0.05
72371977|NCT02693132|144254032|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<0.05
72371978|NCT02693132|144254033|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<0.05
72371979|NCT02693132|144254034|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<0.05
72371980|NCT03116152|144254082|SUPERIORITY||Hazard Ratio (HR)|0.701||||0.032|TWO_SIDED|95.0|0.504|0.972|||Log Rank|||||0.972|0.504|0.032
72371981|NCT03116152|144254083|SUPERIORITY||Hazard Ratio (HR)|1.002||||0.979|TWO_SIDED|95.0|0.722|1.391|||Log Rank|||||1.391|0.722|0.979
72371982|NCT03116152|144254084|SUPERIORITY||Difference in Percentages|6.3|||||TWO_SIDED|95.0|-2.2|15.4||||||||15.4|-2.2|
72371983|NCT03116152|144254085|SUPERIORITY|||||||0.345|||||||Log Rank|||||||0.345
72371984|NCT00862641|144254088|SUPERIORITY_OR_OTHER|||||||0.1451||95.0|||||Cochran-Mantel-Haenszel|Analysis of treatment effect was based on the Cochran-Mantel Haenszel(CMH) test stratified by investigative site. Sites with \<15 subjects were pooled.||||||0.1451
72371985|NCT00862641|144254088|SUPERIORITY_OR_OTHER|||||||0.579||95.0|||||Cochran-Mantel-Haenszel|Analysis of treatment effect was based on the CMH test stratified by investigative site. Sites with less than 15 subjects were pooled.||||||0.5790
72371986|NCT00862641|144254091|SUPERIORITY_OR_OTHER|||||||0.0029||95.0|||||ANCOVA|||P-value applies to 'Change at Hour 2'||||0.0029
72371987|NCT00862641|144254091|SUPERIORITY_OR_OTHER|||||||0.6189||95.0|||||ANCOVA|||P-value applies to 'Change at Hour 2'||||0.6189
72371988|NCT00862641|144254092|SUPERIORITY_OR_OTHER|||||||0.0015||95.0|||||ANCOVA|||P-value applies to 'Change at Hour 2'||||0.0015
72371989|NCT00862641|144254092|SUPERIORITY_OR_OTHER|||||||0.4385||95.0|||||ANCOVA|||P-value applies to 'Change at Hour 2'||||0.4385
72371990|NCT00862641|144254093|SUPERIORITY_OR_OTHER|||||||0.0789||95.0|||||ANCOVA|||P-value applies to 'Change at Hour 2'||||0.0789
72371991|NCT00862641|144254093|SUPERIORITY_OR_OTHER|||||||0.0258||95.0|||||ANCOVA|||P-value applies to 'Change at Hour 2'||||0.0258
72371992|NCT00862641|144254094|SUPERIORITY_OR_OTHER|||||||0.2087||95.0|||||ANCOVA|||P-value applies to 'Change at Hour 2'||||0.2087
72371993|NCT00862641|144254094|SUPERIORITY_OR_OTHER|||||||0.0289||95.0|||||ANCOVA|||P-value applies to 'Change at Hour 2'||||0.0289
72371994|NCT00862641|144254095|SUPERIORITY_OR_OTHER|||||||0.9904||95.0|||||ANCOVA|||"P-value applies to 'Change at Hour 2'~P-value based on ranked analysis of covariance with treatment and investigator site as main effects and baseline value as a covariate in the model."||||0.9904
72371995|NCT00862641|144254095|SUPERIORITY_OR_OTHER|||||||0.8085||95.0|||||ANCOVA|||"P-value applies to 'Change at Hour 2'~P-value based on ranked analysis of covariance with treatment and investigator site as main effects and baseline value as a covariate in the model."||||0.8085
72371996|NCT02448641|144254097|SUPERIORITY||Odds Ratio (OR)|1.33||||0.6743|TWO_SIDED|95.0|0.35|5.09||GLMM: Generalized Linear Mixed Model|Mixed Models Analysis|A GLMM with FMMS responder as outcome, treatment, visit, treatment-visit interaction, pooled site, Baseline FMMS and Baseline mRS scores as covariates||Combined SB623 Implant Vs Sham Surgery group at Month 6||5.09|0.35|0.6743
72371997|NCT02448641|144254098|SUPERIORITY||Odds Ratio (OR)|0.43||||0.1|TWO_SIDED|95.0|0.15|1.18||GLMM: Generalized Linear Mixed Model|Mixed Models Analysis|A GLMM with mRS responder as outcome, treatment, visit, treatment-visit interaction, pooled site and Baseline mRS scores as covariates||Combined SB623 Implant Vs Sham Surgery group at Month 6||1.18|0.15|0.1000
72371998|NCT02448641|144254101|SUPERIORITY||Mean Difference (Net)|-0.36||||0.7788|TWO_SIDED|95.0|-2.9|2.17||Combined SB623 vs. Sham at month 6 MMRM: Mixed Model for Repeated Measures|Mixed Models Analysis|MMRM included treatment, visit, pooled site, corresponding Baseline sub-domain T-score, Baseline mRS score, and the treatment-by-visit interaction|LSMD (Least square mean difference) (SE): -0.36 (1.283)|Statistical analysis: NeuroQOL score for the Upper Extremity Function (Represents Mean Change from Baseline in T-Scores at Month 6)||2.17|-2.90|0.7788
72493589|NCT00511355|144516380|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0||||No correction for multiple testing was made.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for age class applied on the changes from baseline.||P-value compares the change from baseline to Cycle 6 between treatment groups.||||<.0001
72371999|NCT02448641|144254101|SUPERIORITY||Mean Difference (Net)|0.58||||0.5347|TWO_SIDED|95.0|-1.26|2.43||Combined SB623 vs. Sham at month 6 MMRM: Mixed Model for Repeated Measures|Mixed Models Analysis|MMRM included treatment, visit, pooled site, corresponding Baseline sub-domain T-score, Baseline mRS score, and the treatment-by-visit interaction|LSMD (Least square mean difference) (SE): 0.58 (0.934)|Statistical Analysis: NeuroQOL score for Lower Extremity Function (Represents Mean Change from Baseline in T-Scores at Month 6)||2.43|-1.26|0.5347
72372000|NCT02448641|144254103|SUPERIORITY||Mean Difference (Net)|1.2||||0.2959|TWO_SIDED|95.0|-1.1|3.6||MMRM: Mixed effect Model Repeat Measurement|Mixed Models Analysis|MMRM included treatment, visit, pooled site, corresponding Baseline sub-domain T-score, Baseline mRS score, and the treatment-by-visit interaction|LSMD (Least square mean difference) (SE): 1.2 (1.18)|"Change from Baseline at Month 6~Between-group Effect size is calculated as the LS mean difference divided by the model estimate of the pooled SD, obtained from the square root of the diagonal element, associated with the analysis visit summarized, from the covariance matrix."||3.6|-1.1|0.2959
72372001|NCT02448641|144254104|SUPERIORITY||Odds Ratio (OR)|1.36||||0.6854|TWO_SIDED|95.0|0.31|5.92||GLMM: Generalized Linear Mixed Model|Mixed Models Analysis|A GLMM with FMMS responder as outcome, treatment, visit, treatment-visit interaction, pooled site, Baseline FMMS and Baseline mRS scores as covariates||Combined SB623 Implant Vs Sham Surgery group at Month 6||5.92|0.31|0.6854
72372002|NCT05477108|144254109|EQUIVALENCE|For Cmax, the intra-participant CV% in Treatment B (reference arm) was 42.91. An analysis was conducted based on the RSABE method for a partial-replicate 3-way cross-over design. The PK parameter was log-transformed prior to analysis. Bioequivalence was concluded since criteria bound was -0.1028 (\<0) and point estimate for geometric mean ratio was within 80% and 125%.|Geometric Mean Ratio (%)|104.24|||||TWO_SIDED|90.0|95.78|113.44|||||Geometric mean ratio is calculated as A/B.|Statistical Comparison of Key Budesonide Pharmacokinetic Parameters (US approach)||113.44|95.78|
72372003|NCT05477108|144254109|EQUIVALENCE|For Cmax, the intra-participant CV% in Treatment B (reference arm) was 40.85. An analysis was conducted based on the RSABE method for a partial-replicate 3-way cross-over design. The PK parameter was log-transformed prior to analysis. Bioequivalence was concluded since criteria bound was -0.0831 (\<0) and point estimate for geometric mean ratio was within 80% and 125%.|Geometric Mean Ratio (%)|93.45|||||TWO_SIDED|90.0|84.31|103.58|||||Geometric mean ratio is calculated as A/B.|Statistical Comparison of Key Glycopyrronium Pharmacokinetic Parameters (US approach)||103.58|84.31|
72372004|NCT05477108|144254109|EQUIVALENCE|For Cmax, the intra-participant CV% in Treatment B (reference arm) was 40.66. An analysis was conducted based on the RSABE method for a partial-replicate 3-way cross-over design. The PK parameter was log-transformed prior to analysis. Bioequivalence was concluded since criteria bound was -0.0971 (\<0) and point estimate for geometric mean ratio was within 80% and 125%.|Geometric Mean Ratio (%)|100.14|||||TWO_SIDED|90.0|91.9|109.11|||||Geometric mean ratio is calculated as A/B.|Statistical Comparison of Key Formoterol Pharmacokinetic Parameters (US approach)||109.11|91.90|
72372005|NCT05477108|144254109|EQUIVALENCE|For Cmax, the analysis was conducted using an analysis of variance including fixed effects for treatment, sequence, period and subject within sequence. The PK parameter was log-transformed prior to analysis. The intra-participant CV% in Treatment B (reference arm) was 42.66. Bioequivalence was concluded since the 90% CI for the geometric mean ratio were within the expanded equivalence limits of 73.29% to 136.44% and point estimate for geometric mean ratio was within 80% and 125%.|Geometric Mean Ratio (%)|103.12|||||TWO_SIDED|90.0|94.44|112.6|||||Geometric mean ratio is calculated as A/B.|Statistical Comparison of Key Budesonide Pharmacokinetic Parameters (EU approach)||112.60|94.44|
72372006|NCT05477108|144254109|EQUIVALENCE|For Cmax, the analysis was conducted using an analysis of variance including fixed effects for treatment, sequence, period and subject within sequence. The PK parameter was log-transformed prior to analysis. The intra-participant CV% in Treatment B (reference arm) was 40.75. Bioequivalence was concluded since the 90% CI for the geometric mean ratio were within the expanded equivalence limits of 74.24% to 134.70% and point estimate for geometric mean ratio was within 80% and 125%.|Geometric Mean Ratio (%)|93.39|||||TWO_SIDED|90.0|85.29|102.26|||||Geometric mean ratio is calculated as A/B.|Statistical Comparison of Key Glycopyrronium Pharmacokinetic Parameters (EU approach)||102.26|85.29|
72372007|NCT05477108|144254109|EQUIVALENCE|For Cmax, the analysis was conducted using an analysis of variance including fixed effects for treatment, sequence, period and subject within sequence. The PK parameter was log-transformed prior to analysis. The intra-participant CV% in Treatment B (reference arm) was 40.81. Bioequivalence was concluded since the 90% CI for the geometric mean ratio were within the expanded equivalence limits of 74.21% to 134.75% and point estimate for geometric mean ratio was within 80% and 125%.|Geometric Mean Ratio (%)|99.7|||||TWO_SIDED|90.0|91.44|108.71|||||Geometric mean ratio is calculated as A/B.|Statistical Comparison of Key Formoterol Pharmacokinetic Parameters (EU approach)||108.71|91.44|
72372008|NCT05477108|144254110|EQUIVALENCE|For AUCinf, the intra-participant CV% in Treatment B (reference arm) was 34.29. An analysis was conducted based on the RSABE method for a partial-replicate 3-way cross-over design. The PK parameter was log-transformed prior to analysis. Bioequivalence was concluded since criteria bound was -0.0593 (\<0) and point estimate for geometric mean ratio was within 80% and 125%.|Geometric Mean Ratio (%)|107.76|||||TWO_SIDED|90.0|100.35|115.72|||||Geometric mean ratio is calculated as A/B.|Statistical Comparison of Key Budesonide Pharmacokinetic Parameters (US approach)||115.72|100.35|
72372009|NCT05477108|144254110|EQUIVALENCE|For AUCinf, the intra-participant CV% in Treatment B (reference arm) was 86.08. An analysis was conducted based on the RSABE method for a partial-replicate 3-way cross-over design. The PK parameter was log-transformed prior to analysis. Bioequivalence was concluded since criteria bound was -0.2925 (\<0) and point estimate for geometric mean ratio was within 80% and 125%.|Geometric Ratio Mean (%)|112.22|||||TWO_SIDED|90.0|92.27|136.49|||||Geometric mean ratio is calculated as A/B.|Statistical Comparison of Key Glycopyrronium Pharmacokinetic Parameters (US approach)||136.49|92.27|
72372010|NCT05477108|144254110|EQUIVALENCE|For AUCinf, the intra-participant CV% in Treatment B (reference arm) was 47.07. An analysis was conducted based on the RSABE method for a partial-replicate 3-way cross-over design. The PK parameter was log-transformed prior to analysis. Bioequivalence was concluded since criteria bound was -0.1250 (\<0) and point estimate for geometric mean ratio was within 80% and 125%.|Geometric Mean Ratio (%)|101.45|||||TWO_SIDED|90.0|91.76|112.15|||||Geometric mean ratio is calculated as A/B.|Statistical Comparison of Key Formoterol Pharmacokinetic Parameters (US approach)||112.15|91.76|
72372011|NCT05477108|144254111|EQUIVALENCE|For AUClast, the intra-participant CV% in Treatment B (reference arm) was 35.68. An analysis was conducted based on the RSABE method for a partial-replicate 3-way cross-over design. The PK parameter was log-transformed prior to analysis. Bioequivalence was concluded since criteria bound was -0.0668 (\<0) and point estimate for geometric mean ratio was within 80% and 125%.|Geometric Mean Ratio (%)|106.87|||||TWO_SIDED|90.0|99.3|115.01|||||Geometric mean ratio is calculated as A/B.|Statistical Comparison of Key Budesonide Pharmacokinetic Parameters (US approach)||115.01|99.30|
72372012|NCT05477108|144254111|EQUIVALENCE|For AUClast, the intra-participant CV% in Treatment B (reference arm) was 74.17. An analysis was conducted based on the RSABE method for a partial-replicate 3-way cross-over design. The PK parameter was log-transformed prior to analysis. Bioequivalence was concluded since criteria bound was -0.2735 (\<0) and point estimate for geometric mean ratio was within 80% and 125%.|Geometric Mean Ratio (%)|102.02|||||TWO_SIDED|90.0|89.12|116.79|||||Geometric mean ratio is calculated as A/B.|Statistical Comparison of Key Glycopyrronium Pharmacokinetic Parameters (US approach)||116.79|89.12|
72372013|NCT05477108|144254111|EQUIVALENCE|For AUClast, the intra-participant CV% in Treatment B (reference arm) was 66.88. An analysis was conducted based on the RSABE method for a partial-replicate 3-way cross-over design. The PK parameter was log-transformed prior to analysis. Bioequivalence was concluded since criteria bound was -0.2210 (\<0) and point estimate for geometric mean ratio was within 80% and 125%.|Geometric Mean Ratio (%)|107.76|||||TWO_SIDED|90.0|94.91|122.36|||||Geometric mean ratio is calculated as A/B.|Statistical Comparison of Key Formoterol Pharmacokinetic Parameters (US approach)||122.36|94.91|
72372014|NCT05477108|144254111|EQUIVALENCE|For AUClast, the analysis was conducted using an analysis of variance including fixed effects for treatment, sequence, period and subject within sequence. The PK parameter was log-transformed prior to analysis. Bioequivalence was concluded since the 90% CI for the geometric mean ratio were fully contained within the predefined equivalence limits of 80% to 125%.|Geometric Mean ratio (%)|106.1|||||TWO_SIDED|90.0|98.39|114.41|||||Geometric mean ratio is calculated as A/B.|Statistical Comparison of Key Budesonide Pharmacokinetic Parameters (EU approach)||114.41|98.39|
72372015|NCT05477108|144254111|EQUIVALENCE|For AUClast, the analysis was conducted using an analysis of variance including fixed effects for treatment, sequence, period and subject within sequence. The PK parameter was log-transformed prior to analysis. Bioequivalence was concluded since the 90% CI for the geometric mean ratio were fully contained within the predefined equivalence limits of 80% to 125%.|Geometric Mean Ratio (%)|97.02|||||TWO_SIDED|90.0|84.18|111.82|||||Geometric mean ratio is calculated as A/B.|Statistical Comparison of Key Glycopyrronium Pharmacokinetic Parameters (EU approach)||111.82|84.18|
72372016|NCT05477108|144254111|EQUIVALENCE|For AUClast, the analysis was conducted using an analysis of variance including fixed effects for treatment, sequence, period and subject within sequence. The PK parameter was log-transformed prior to analysis. Bioequivalence was concluded since the 90% CI for the geometric mean ratio were fully contained within the predefined equivalence limits of 80% to 125%.|Geometric Mean Ratio (%)|105.74|||||TWO_SIDED|90.0|92.59|120.75|||||Geometric mean ratio is calculated as A/B.|Statistical Comparison of Key Formoterol Pharmacokinetic Parameters (EU approach)||120.75|92.59|
72372017|NCT02660983|144254119|SUPERIORITY||Difference in least square (LS) means|-0.58||||0.3455|TWO_SIDED|95.0|-1.79|0.63|||ANCOVA|||||0.63|-1.79|0.3455
72372018|NCT02660983|144254120|SUPERIORITY||Difference in LS means|-0.12||||0.257|TWO_SIDED|95.0|-0.32|0.09|||ANCOVA||LS mean of Donepezil group - LS mean of Placebo (when the difference of LS mean scores were less than 0, considered as demonstrated hypothesis), analyzed with ANCOVA model with baseline (CIBIS) as covariate and treatment as main effect.|||0.09|-0.32|0.2570
72372019|NCT02660983|144254121|SUPERIORITY||Difference in LS means|0.65||||0.0396|TWO_SIDED|95.0|0.03|1.26|||ANCOVA|||||1.26|0.03|0.0396
72372020|NCT02660983|144254122|SUPERIORITY||Difference in LS means|-7.73||||0.2213|TWO_SIDED|95.0|-20.13|4.68|||ANCOVA|||Part A||4.68|-20.13|0.2213
72372021|NCT02660983|144254122|SUPERIORITY||Difference in LS means|-14.88||||0.0551|TWO_SIDED|95.0|-30.1|0.33|||ANCOVA|||Part B||0.33|-30.10|0.0551
72372022|NCT03376295|144254127|OTHER||Hazard Ratio (HR)|1.04|||||TWO_SIDED|95.0|0.9|1.2|||Cox proportional hazards model||The hazard ratio (HR) is adjusted HR after matching on high-dimensional propensity scores, sex and calendar time, adjusted further for the deciles of propensity score.|The Cox proportional hazard regression model was used to perform for moderate/severe exacerbation that assesses the effect of current use of LABA-TIO combination versus the LABA-ICS combination on the risk of a first COPD exacerbation.||1.20|0.90|
72372023|NCT03376295|144254127|OTHER||Hazard Ratio (HR)|0.94|||||TWO_SIDED|95.0|0.65|1.36|||Cox proportional hazards model||HR presented is adjusted HR after matching on high-dimensional propensity scores, sex and calendar time, adjusted further for the deciles of propensity score.|The Cox proportional hazard regression model was used to perform for severe exacerbation that assesses the effect of current use of LABA-TIO combination versus the LABA-ICS combination on the risk of a first COPD exacerbation.||1.36|0.65|
72372024|NCT03376295|144254128|OTHER||Rate ratio (RR)|1.07|||||TWO_SIDED|95.0|0.92|1.25|||Negative binomial model||The rate ratio (RR) (LABA-TIO combination versus the LABA-ICS combination) is adjusted RR after matching on high-dimensional propensity scores, sex and calendar time, adjusted further for the deciles of propensity score.|Moderate/severe exacerbation||1.25|0.92|
72372025|NCT03376295|144254128|OTHER||Rate ratio (RR)|0.85|||||TWO_SIDED|95.0|0.55|1.33|||Negative binomial model||The RR (LABA-TIO combination versus the LABA-ICS combination) is adjusted RR after matching on high-dimensional propensity scores, sex and calendar time, adjusted further for the deciles of propensity score.|Severe exacerbation||1.33|0.55|
72372026|NCT03376295|144254129|OTHER||Hazard Ratio (HR)|0.66|||||TWO_SIDED|95.0|0.42|1.05|||Cox proportional hazards model||The HR is adjusted HR after matching on high-dimensional propensity scores, sex and calendar time, adjusted further for the deciles of propensity score|The cox proportional hazard regression model was used to perform an as-treated analysis that assesses the effect of current use of LABA-TIO combination versus the LABA-ICS combination on the risk of a first COPD exacerbation.||1.05|0.42|
72372027|NCT03376295|144254129|OTHER||Hazard Ratio (HR)|0.66|||||TWO_SIDED|95.0|0.48|0.92|||Cox proportional hazards model||The HR is adjusted HR after matching on high-dimensional propensity scores, sex and calendar time, adjusted further for the deciles of propensity score|The Cox proportional hazard regression model was used to perform an on-treatment analysis that assesses the effect of current use of LABA-TIO combination versus the LABA-ICS combination on the risk of a first COPD exacerbation.||0.92|0.48|
72372028|NCT00893815|144254130|OTHER||Odds Ratio (OR)|0.55||||0.09|TWO_SIDED|95.0|0.27|1.1||Threshold for statistical significance: 0.05|Regression, Logistic||HIV-positive / HIV-negative|||1.10|0.27|0.09
72372029|NCT00893815|144254131|OTHER||Odds Ratio (OR)|0.75||||0.45|TWO_SIDED|95.0|0.35|1.61||Threshold for statistical significance: 0.05|Regression, Logistic||HIV-positive / HIV-negative|Comparing prevalence of verbal fluency impairment between HIV-positive and HIV-negative military beneficiaries||1.61|0.35|0.45
72372030|NCT00893815|144254131|OTHER||Odds Ratio (OR)|0.74||||0.43|TWO_SIDED|95.0|0.35|1.56||Threshold for statistical significance: 0.05|Regression, Logistic||HIV-positive / HIV-negative|Comparing prevalence of abstraction executive functioning impairment between HIV-positive and HIV-negative military beneficiaries||1.56|0.35|0.43
72372031|NCT00893815|144254131|OTHER||Odds Ratio (OR)|1.45||||0.56|TWO_SIDED|95.0|0.41|5.17||Threshold for statistical significance: 0.05|Regression, Logistic||HIV-positive / HIV-negative|Comparing prevalence of speed of information processing impairment between HIV-positive and HIV-negative military beneficiaries||5.17|0.41|0.56
72372032|NCT00893815|144254131|OTHER||Odds Ratio (OR)|1.32||||0.49|TWO_SIDED|95.0|0.6|2.93||Threshold for statistical significance: 0.05|Regression, Logistic||HIV-positive / HIV-negative|Comparing prevalence of attention/working memory impairment between HIV-positive and HIV-negative military beneficiaries||2.93|0.60|0.49
72372033|NCT00893815|144254131|OTHER||Odds Ratio (OR)|0.43||||0.01|TWO_SIDED|95.0|0.22|0.84||Threshold for statistical significance: 0.05|Regression, Logistic||HIV-positive / HIV-negative|Comparing prevalence of learning impairment between HIV-positive and HIV-negative military beneficiaries||0.84|0.22|0.01
72372034|NCT00893815|144254131|OTHER||Odds Ratio (OR)|1.39||||0.46|TWO_SIDED|95.0|0.58|3.34||Threshold for statistical significance: 0.05|Regression, Logistic||HIV-positive / HIV-negative|Comparing prevalence of recall impairment between HIV-positive and HIV-negative military beneficiaries||3.34|0.58|0.46
72372035|NCT00893815|144254131|OTHER||Odds Ratio (OR)|0.89||||0.76|TWO_SIDED|95.0|0.43|1.85||Threshold for statistical significance: 0.05|Regression, Logistic||HIV-positive / HIV-negative|Comparing prevalence of motor speed \& dexterity impairment between HIV-positive and HIV-negative military beneficiaries||1.85|0.43|0.76
72372036|NCT04303195|144254142|SUPERIORITY||Mean Difference (Final Values)|-0.72|STANDARD_ERROR_OF_MEAN|0.479||0.135|TWO_SIDED|95.0|-1.67|0.23||The threshold for statistical significance was p = 0.05.|ANOVA|||||0.23|-1.67|0.1350
72372037|NCT04303195|144254142|SUPERIORITY||Mean Difference (Final Values)|-0.82|STANDARD_ERROR_OF_MEAN|0.493||0.0997|TWO_SIDED|95.0|-1.79|0.16||The threshold for statistical significance was p = 0.05.|ANCOVA|||||0.16|-1.79|0.0997
72372038|NCT04303195|144254142|SUPERIORITY||Mean Difference (Final Values)|-0.61|STANDARD_ERROR_OF_MEAN|0.492||0.2195|TWO_SIDED|95.0|-1.58|0.37||The threshold for statistical significance was p = 0.05.|ANCOVA|||||0.37|-1.58|0.2195
72372039|NCT04303195|144254143|SUPERIORITY||Mean Difference (Final Values)|-0.13|STANDARD_ERROR_OF_MEAN|0.498||0.7944|TWO_SIDED|95.0|-1.11|0.85||The threshold for statistical significance was p = 0.05.|ANCOVA|||||0.85|-1.11|0.7944
72372040|NCT04303195|144254143|SUPERIORITY||Mean Difference (Final Values)|-0.35|STANDARD_ERROR_OF_MEAN|0.51||0.4956|TWO_SIDED|95.0|-1.36|0.66||The threshold for statistical significance was p = 0.05.|ANCOVA|||||0.66|-1.36|0.4956
72372041|NCT04303195|144254143|SUPERIORITY||Mean Difference (Final Values)|0.25|STANDARD_ERROR_OF_MEAN|0.511||0.626|TWO_SIDED|95.0|-0.76|1.26||The threshold for statistical significance was p = 0.05.|ANCOVA|||||1.26|-0.76|0.6260
72372042|NCT04303195|144254144|SUPERIORITY||Mean Difference (Final Values)|-0.08|STANDARD_ERROR_OF_MEAN|0.543||0.8866|TWO_SIDED|95.0|-1.15|1.0||The threshold for statistical significance was p = 0.05.|ANCOVA|||||1.00|-1.15|0.8866
72372043|NCT04303195|144254144|SUPERIORITY||Mean Difference (Final Values)|-0.09|STANDARD_ERROR_OF_MEAN|0.558||0.8699|TWO_SIDED|95.0|-1.19|1.01||The threshold for statistical significance was p = 0.05.|ANCOVA|||||1.01|-1.19|0.8699
72372044|NCT04303195|144254144|SUPERIORITY||Mean Difference (Final Values)|0.19|STANDARD_ERROR_OF_MEAN|0.556||0.7297|TWO_SIDED|95.0|-0.91|1.29||The threshold for statistical significance was p = 0.05.|ANCOVA|||||1.29|-0.91|0.7297
72372045|NCT04303195|144254145|SUPERIORITY||Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.409||0.9034|TWO_SIDED|95.0|-0.76|0.86||The threshold for statistical significance was p = 0.05.|ANCOVA|||||0.86|-0.76|0.9034
72372046|NCT04303195|144254145|SUPERIORITY||Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.33||0.9742|TWO_SIDED|95.0|-0.68|0.63||The threshold for statistical significance was p = 0.05.|ANCOVA|||||0.63|-0.68|0.9742
72372047|NCT04303195|144254145|SUPERIORITY||Mean Difference (Final Values)|0.51|STANDARD_ERROR_OF_MEAN|0.417||0.2235|TWO_SIDED|95.0|-0.31|1.33||The threshold for statistical significance was p = 0.05.|ANCOVA|||||1.33|-0.31|0.2235
72372048|NCT04303195|144254146|SUPERIORITY||Mean Difference (Final Values)|-0.11|STANDARD_ERROR_OF_MEAN|0.118||0.3567|TWO_SIDED|95.0|-0.34|0.12||The threshold for statistical significance was p = 0.05.|ANCOVA|||||0.12|-0.34|0.3567
72372049|NCT04303195|144254146|SUPERIORITY||Mean Difference (Final Values)|-0.19|STANDARD_ERROR_OF_MEAN|0.12||0.1129|TWO_SIDED|95.0|-0.43|0.05||The threshold for statistical significance was p = 0.05.|ANCOVA|||||0.05|-0.43|0.1129
72372050|NCT04303195|144254146|SUPERIORITY||Mean Difference (Final Values)|-0.09|STANDARD_ERROR_OF_MEAN|0.12||0.459|TWO_SIDED|95.0|-0.33|0.15||The threshold for statistical significance was p = 0.05.|ANCOVA|||||0.15|-0.33|0.4590
72372051|NCT04303195|144254147|SUPERIORITY||Mean Difference (Final Values)|-0.31|STANDARD_ERROR_OF_MEAN|0.485||0.525|TWO_SIDED|95.0|-1.27|0.65||The threshold for statistical significance was p = 0.05.|ANCOVA|||||0.65|-1.27|0.5250
72372052|NCT04303195|144254147|SUPERIORITY||Mean Difference (Final Values)|-0.42|STANDARD_ERROR_OF_MEAN|0.498||0.3991|TWO_SIDED|95.0|-1.41|0.56||The threshold for statistical significance was p = 0.05.|ANCOVA|||||0.56|-1.41|0.3991
72372053|NCT04303195|144254147|SUPERIORITY||Mean Difference (Final Values)|-0.06|STANDARD_ERROR_OF_MEAN|0.497||0.9006|TWO_SIDED|95.0|-1.05|0.92||The threshold for statistical significance was p = 0.05.|ANCOVA|||||0.92|-1.05|0.9006
72372054|NCT04303195|144254148|SUPERIORITY||Mean Difference (Final Values)|-0.23|STANDARD_ERROR_OF_MEAN|0.444||0.6009|TWO_SIDED|95.0|-1.11|0.64||The threshold for statistical significance was p = 0.05.|ANCOVA|||||0.64|-1.11|0.6009
72372055|NCT04303195|144254148|SUPERIORITY||Mean Difference (Final Values)|-0.33|STANDARD_ERROR_OF_MEAN|0.454||0.4654|TWO_SIDED|95.0|-1.23|0.56||The threshold for statistical significance was p = 0.05.|ANCOVA|||||0.56|-1.23|0.4654
72372056|NCT04303195|144254148|SUPERIORITY||Mean Difference (Final Values)|0.07|STANDARD_ERROR_OF_MEAN|0.455||0.8842|TWO_SIDED|95.0|-0.83|0.97||The threshold for statistical significance was p = 0.05.|ANCOVA|||||0.97|-0.83|0.8842
72372057|NCT06457204|144254149|OTHER||Ratio of adjusted geometric means [%]|101.6|||||TWO_SIDED|90.0|98.4|105.0|||||"Ratio of adjusted geometric means \[%\] calculated as: test/reference\*100.~Intra-individual geometric coefficient of variation (gCV) \[%\] = 6.9."|Analysis of variance (ANOVA) on the logarithmic scale included effects for sequence, subjects nested within sequences, period and treatment. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed. confidence intervals (CIs) were calculated based on the residual error from the ANOVA and quantiles from the t-distribution. These quantities were then back-transformed to the original scale to provide the point estimate and 90% CIs.||105.0|98.4|
72372058|NCT06457204|144254150|OTHER||Ratio of adjusted geometric means [%]|98.3|||||TWO_SIDED|90.0|91.6|105.5|||||"Ratio of adjusted geometric means \[%\] calculated as: test/reference\*100.~Intra-individual geometric coefficient of variation (gCV) \[%\] = 15.0."|Analysis of variance (ANOVA) on the logarithmic scale included effects for sequence, subjects nested within sequences, period and treatment. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed. confidence intervals (CIs) were calculated based on the residual error from the ANOVA and quantiles from the t-distribution. These quantities were then back-transformed to the original scale to provide the point estimate and 90% CIs.||105.5|91.6|
72372059|NCT06457204|144254151|OTHER||Ratio of adjusted geometric means [%]|101.6|||||TWO_SIDED|90.0|98.2|105.0|||||"Ratio of adjusted geometric means \[%\] calculated as: test/reference\*100.~Intra-individual geometric coefficient of variation (gCV) \[%\] = 7.1."|Analysis of variance (ANOVA) on the logarithmic scale included effects for sequence, subjects nested within sequences, period and treatment. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed. confidence intervals (CIs) were calculated based on the residual error from the ANOVA and quantiles from the t-distribution. These quantities were then back-transformed to the original scale to provide the point estimate and 90% CIs.||105.0|98.2|
72372060|NCT01065454|144254152|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|-2.71||||0.1044|TWO_SIDED|95.0|-5.99|0.057||Baseline value, treatment group and region were used as fixed effects in the ANCOVA model|ANCOVA|||||0.057|-5.99|0.1044
72372061|NCT01065454|144254152|SUPERIORITY_OR_OTHER_LEGACY||LSMEANS Difference|-1.38||||0.5292|TWO_SIDED|95.0|-5.71|2.94||Baseline value, treatment group and region were used as fixed effects in the ANCOVA model|ANCOVA|||||2.94|-5.71|0.5292
72372062|NCT01065454|144254152|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|-4.51||||0.0278|TWO_SIDED|95.0|-8.52|-0.5||Baseline value, treatment group and region were used as fixed effects in the ANCOVA model|ANCOVA|||||-0.50|-8.52|0.0278
72372063|NCT01065454|144254152|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|1.8||||0.3821|TWO_SIDED|95.0|-2.25|5.84||Baseline value, treatment group and region were used as fixed effects in the ANCOVA model|ANCOVA|||||5.84|-2.25|0.3821
72372064|NCT01065454|144254152|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|3.13||||0.2084|TWO_SIDED|95.0|-1.76|8.02||Baseline value, treatment group and region were used as fixed effects in the ANCOVA model|ANCOVA|||||8.02|-1.76|0.2084
72372065|NCT01065454|144254152|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|-1.33||||0.5442|TWO_SIDED|95.0|-5.66|3.0||Baseline value, treatment group and region were used as fixed effects in the ANCOVA model|ANCOVA|||||3.00|-5.66|0.5442
72372066|NCT01065454|144254153|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|1.87|||||TWO_SIDED|95.0|-0.83|4.56||||||||4.56|-0.83|
72372067|NCT01065454|144254153|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|0.2|||||TWO_SIDED|95.0|-3.12|3.51||||||||3.51|-3.12|
72372068|NCT01065454|144254153|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|0.23|||||TWO_SIDED|95.0|-3.31|3.77||||||||3.77|-3.31|
72372069|NCT01065454|144254154|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|-46.59|||||TWO_SIDED|95.0|-89.4|-3.8||||||||-3.8|-89.4|
72372070|NCT01065454|144254154|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|-32.26|||||TWO_SIDED|95.0|-84.9|20.4||||||||20.4|-84.9|
72372071|NCT01065454|144254154|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|-26.52|||||TWO_SIDED|95.0|-83.0|30.0||||||||30.0|-83.0|
72372072|NCT01065454|144254155|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|-89.17|||||TWO_SIDED|95.0|-172.9|5.5||||||||5.5|-172.9|
72372073|NCT01065454|144254155|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|-58.22|||||TWO_SIDED|95.0|-162.1|45.6||||||||45.6|-162.1|
72372074|NCT01065454|144254155|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|-43.22|||||TWO_SIDED|95.0|-153.7|67.1||||||||67.1|-153.7|
72372075|NCT01065454|144254156|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|-239.31|||||TWO_SIDED|95.0|-363.4|-115.3||||||||-115.3|-363.4|
72372076|NCT01065454|144254156|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|-120.89|||||TWO_SIDED|95.0|-274.4|32.6||||||||32.6|-274.4|
72372077|NCT01065454|144254156|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|-25.54|||||TWO_SIDED|95.0|-189.3|138.2||||||||138.2|-189.3|
72372078|NCT01065454|144254157|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|-446.49|||||TWO_SIDED|95.0|-687.4|-205.6||||||||-205.6|-687.4|
72372079|NCT01065454|144254157|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|-231.57|||||TWO_SIDED|95.0|-530.4|67.2||||||||67.2|-530.4|
72372080|NCT01065454|144254157|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|-34.97|||||TWO_SIDED|95.0|-353.7|283.7||||||||283.7|-353.7|
72372081|NCT01065454|144254158|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|-1.27|||||TWO_SIDED|95.0|-3.1|0.5||||||||0.5|-3.1|
72372082|NCT01065454|144254158|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|-0.88|||||TWO_SIDED|95.0|-3.1|1.3||||||||1.3|-3.1|
72372083|NCT01065454|144254158|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|-0.84|||||TWO_SIDED|95.0|-3.2|1.5||||||||1.5|-3.2|
72372084|NCT01065454|144254159|SUPERIORITY_OR_OTHER_LEGACY||LSS-MEANS Difference|-2.07|||||TWO_SIDED|95.0|-5.0|0.8||||||||0.8|-5.0|
72372085|NCT01065454|144254159|SUPERIORITY_OR_OTHER_LEGACY||LS_MEANS|1.39|||||TWO_SIDED|95.0|-2.1|4.9||||||||4.9|-2.1|
72372086|NCT01065454|144254159|SUPERIORITY_OR_OTHER_LEGACY||LS_MEANS Difference|-1.13|||||TWO_SIDED|95.0|-4.9|2.7||||||||2.7|-4.9|
72372087|NCT01065454|144254160|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|0.28|||||TWO_SIDED|95.0|-0.58|1.14||||||||1.14|-0.58|
72372088|NCT01065454|144254160|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|0.82|||||TWO_SIDED|95.0|-0.23|1.87||||||||1.87|-0.23|
72372089|NCT01065454|144254160|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|-0.03|||||TWO_SIDED|95.0|-1.11|1.06||||||||1.06|-1.11|
72372090|NCT01065454|144254161|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|-3.84|||||TWO_SIDED|95.0|-8.76|1.09||||||||1.09|-8.76|
72372091|NCT01065454|144254161|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANs Difference|-0.02|||||TWO_SIDED|95.0|-6.05|6.01||||||||6.01|-6.05|
72372092|NCT01065454|144254161|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|-2.43|||||TWO_SIDED|95.0|-8.93|4.06||||||||4.06|-8.93|
72372093|NCT01065454|144254162|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|0.51|||||TWO_SIDED|95.0|-0.21|1.24||||||||1.24|-0.21|
72372094|NCT01065454|144254162|SUPERIORITY_OR_OTHER_LEGACY||LS_MEANS Difference|0.81|||||TWO_SIDED|95.0|-0.07|1.69||||||||1.69|-0.07|
72372095|NCT01065454|144254162|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|0.2|||||TWO_SIDED|95.0|-0.74|1.15||||||||1.15|-0.74|
72372096|NCT01065454|144254163|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|-5.06|||||TWO_SIDED|95.0|-17.33|7.22||||||||7.22|-17.33|
72372097|NCT01065454|144254163|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|0.28|||||TWO_SIDED|95.0|-14.55|15.11||||||||15.11|-14.55|
72372098|NCT01065454|144254163|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|-5.18|||||TWO_SIDED|95.0|-21.05|10.69||||||||10.69|-21.05|
72372099|NCT01065454|144254164|SUPERIORITY_OR_OTHER_LEGACY||LS_MEANS Difference|-4.27|||||TWO_SIDED|95.0|-21.13|12.6||||||||12.60|-21.13|
72372100|NCT01065454|144254164|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|2.78|||||TWO_SIDED|95.0|-17.59|23.16||||||||23.16|-17.59|
72372101|NCT01065454|144254164|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|-4.61|||||TWO_SIDED|95.0|-26.43|17.2||||||||17.20|-26.43|
72372102|NCT01065454|144254165|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|5.29|||||TWO_SIDED|95.0|-7.38|17.95||||||||17.95|-7.38|
72618291|NCT00286455|144767657|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.084||||0.002|TWO_SIDED|95.0|-0.137|-0.032||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.032|-0.137|0.002
72372103|NCT01065454|144254165|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|6.47|||||TWO_SIDED|95.0|-9.79|22.73||||||||22.73|-9.79|
72372104|NCT01065454|144254165|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|10.35|||||TWO_SIDED|95.0|-6.14|26.84||||||||26.84|-6.14|
72372105|NCT01065454|144254166|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|-0.15|||||TWO_SIDED|95.0|-0.55|0.24||||||||0.24|-0.55|
72493590|NCT00511355|144516381|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0078||95.0||||No correction for multiple testing was made.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for age class applied on the changes from baseline.||P-value compares the change from baseline to Cycle 6 between treatment groups.||||0.0078
72372106|NCT01065454|144254166|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|0.17|||||TWO_SIDED|95.0|-0.34|0.67||||||||0.67|-0.34|
72372107|NCT01065454|144254166|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|0.06|||||TWO_SIDED|95.0|-0.45|0.56||||||||0.56|-0.45|
72372108|NCT01065454|144254167|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|10.17|||||TWO_SIDED|95.0|-18.48|38.81||||||||38.81|-18.48|
72372109|NCT01065454|144254167|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|7.92|||||TWO_SIDED|95.0|-26.76|42.59||||||||42.59|-26.76|
72372110|NCT01065454|144254167|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|-6.15|||||TWO_SIDED|95.0|-44.08|31.78||||||||31.78|-44.08|
72372111|NCT01065454|144254169|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|0.62|||||TWO_SIDED|95.0|-13.36|14.61||||||||14.61|-13.36|
72372112|NCT01065454|144254169|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|-9.46|||||TWO_SIDED|95.0|-24.32|5.39||||||||5.39|-24.32|
72372113|NCT01065454|144254169|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|-6.07|||||TWO_SIDED|95.0|-22.26|10.13||||||||10.13|-22.26|
72372114|NCT01065454|144254171|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|0.03|||||TWO_SIDED|95.0|-0.04|0.1||||||||0.10|-0.04|
72372115|NCT01065454|144254171|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|0.01|||||TWO_SIDED|95.0|-0.07|0.09||||||||0.09|-0.07|
72372116|NCT01065454|144254171|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|0.02|||||TWO_SIDED|95.0|-0.07|0.11||||||||0.11|-0.07|
72372117|NCT01065454|144254172|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|-6.8|||||TWO_SIDED|95.0|-12.81|-0.78||||||||-0.78|-12.81|
72372118|NCT01065454|144254172|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|-6.81|||||TWO_SIDED|95.0|-13.96|0.35||||||||0.35|-13.96|
72372119|NCT01065454|144254172|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|-7.5|||||TWO_SIDED|95.0|-15.29|0.28||||||||0.28|-15.29|
72372120|NCT01065454|144254173|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|-24.62|||||TWO_SIDED|95.0|-117.58|68.33||||||||68.33|-117.58|
72372121|NCT01065454|144254173|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|-53.29|||||TWO_SIDED|95.0|-162.46|55.88||||||||55.88|-162.46|
72372122|NCT01065454|144254173|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|-8.36|||||TWO_SIDED|95.0|-135.78|119.06||||||||119.06|-135.78|
72372123|NCT01065454|144254174|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|-407.34|||||TWO_SIDED|95.0|-1055.23|240.54||||||||240.54|-1055.23|
72372124|NCT01065454|144254174|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|-447.26|||||TWO_SIDED|95.0|-1212.74|318.22||||||||318.22|-1212.74|
72372125|NCT01065454|144254174|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|-517.48|||||TWO_SIDED|95.0|-1369.48|334.53||||||||334.53|-1369.48|
72372126|NCT01065454|144254175|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|0.0|||||TWO_SIDED|95.0|-0.01|0.01||||||||0.01|-0.01|
72372127|NCT01065454|144254175|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|-0.01|||||TWO_SIDED|95.0|-0.02|0.0||||||||0.00|-0.02|
72372128|NCT01065454|144254175|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|-0.01|||||TWO_SIDED|95.0|-0.02|0.01||||||||0.01|-0.02|
72372129|NCT01065454|144254176|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|0.0|||||TWO_SIDED|95.0|-0.04|0.03||||||||0.03|-0.04|
72372130|NCT01065454|144254176|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|0.0|||||TWO_SIDED|95.0|-0.04|0.05||||||||0.05|-0.04|
72372131|NCT01065454|144254176|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|-0.02|||||TWO_SIDED|95.0|-0.07|0.03||||||||0.03|-0.07|
72372132|NCT01065454|144254177|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANSA Difference|-14.13|||||TWO_SIDED|95.0|-30.79|2.53||||||||2.53|-30.79|
72372133|NCT01065454|144254177|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|-12.73|||||TWO_SIDED|95.0|-32.89|7.43||||||||7.43|-32.89|
72372134|NCT01065454|144254177|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|-18.27|||||TWO_SIDED|95.0|-41.53|5.0||||||||5.00|-41.53|
72372135|NCT05688670|144254180|SUPERIORITY||Mean Difference (Final Values)|-0.39||||0.001|TWO_SIDED|95.0|-0.59|-0.18|||t-test, 2 sided|||||-0.18|-0.59|0.001
72372136|NCT05688670|144254181|SUPERIORITY||Mean Difference (Final Values)|-0.06||||0.41|TWO_SIDED|95.0|-0.2|0.08|||t-test, 2 sided|||12-24 hour postoperative opioid use||0.08|-0.20|0.41
72372137|NCT05688670|144254181|SUPERIORITY||Mean Difference (Final Values)|-0.16||||0.14|TWO_SIDED|95.0|-0.37|0.06|||t-test, 2 sided|||24-48 hour postoperative opioid use||0.06|-0.37|0.14
72372138|NCT05688670|144254181|SUPERIORITY||Mean Difference (Final Values)|-0.21||||0.16|TWO_SIDED|95.0|-0.52|0.09|||t-test, 2 sided|||12-48 hours hours after surgery||0.09|-0.52|0.16
72372139|NCT05688670|144254182|SUPERIORITY||Mean Difference (Final Values)|-0.64||||0.004|TWO_SIDED|95.0|-1.02|-0.22|||t-test, 2 sided|||||-0.22|-1.02|0.004
72372140|NCT05688670|144254183|SUPERIORITY||Mean Difference (Final Values)|-49.5||||0.002|TWO_SIDED|95.0|-78.9|-20.1|||t-test, 2 sided|||||-20.1|-78.9|0.002
72372141|NCT04219085|144254184|SUPERIORITY|||||||1|||||||t-test, 2 sided|||||||1.0
72372142|NCT04219085|144254185|SUPERIORITY|||||||0.03|||||||t-test, 2 sided|||||||0.03
72372143|NCT04219085|144254186|SUPERIORITY|||||||0.85|||||||t-test, 2 sided|||||||0.85
72372144|NCT01909011|144254192|SUPERIORITY_OR_OTHER|||||||0.05|TWO_SIDED||||||t-test, 2 sided|||||||0.05
72372145|NCT01909011|144254193|SUPERIORITY_OR_OTHER|||||||0.066|TWO_SIDED||||||t-test, 2 sided|||||||0.066
72372146|NCT01909011|144254194|SUPERIORITY_OR_OTHER|||||||0.016|TWO_SIDED||||||t-test, 2 sided|||||||0.016
72372147|NCT00695097|144254195|SUPERIORITY_OR_OTHER|||||||0.25||95.0||||P \< 0.05 threshold of significance|t-test, 2 sided|||Pretreatment (Baseline)compared to post-treatment (follow-up) CD3 cell density||||0.25
72372148|NCT00695097|144254195|SUPERIORITY_OR_OTHER|||||||0.46||95.0||||P \< 0.05 threshold of significance|t-test, 2 sided|||Pretreatment (Baseline) compared to post-treatment (follow-up) CD3 cell density||||0.46
72372149|NCT00695097|144254195|SUPERIORITY_OR_OTHER|||||||0.054||95.0||||P \< 0.05 threshold of significance|t-test, 2 sided|||pretreatment (baseline) compared to post-treatment (follow-up) biopsy CD20 cell density||||0.054
72372150|NCT00695097|144254195|SUPERIORITY_OR_OTHER|||||||0.62||95.0||||P \< 0.05 threshold of significance|t-test, 2 sided|||Pretreatment (baseline) compared to post-treatment (follow-up) CD20 cell density||||0.62
72372151|NCT05141448|144254255|NON_INFERIORITY|Non-inferiority was declared if the upper limit of the 95% confidence interval of was below 0.05 logMAR|Mean Difference (Final Values)|0.04|STANDARD_ERROR_OF_MEAN|0.011|||TWO_SIDED|95.0|0.02|0.06|||Linear Mixed Model|Kenward and Roger method was used for denominator degrees of freedom.|Mean difference was calculated as senofilcon A C3 (EMO-118) minus omafilcon A|||0.06|0.02|
72372152|NCT01068964|144254289|NON_INFERIORITY_OR_EQUIVALENCE|A non-inferiority margin of 1.5 mmHg was used. That is, if the upper limit of the 95% confidence interval for the difference in the mean diurnal IOP change between the two groups (Group 1 minus Group 2) is less than 1.5 mm Hg, then the null hypothesis will be rejected. The study had an 85% power.|Mean Difference (Final Values)|-0.556|||||TWO_SIDED|95.0|-1.68|0.57||||||A non-inferiority test was performed for comparing the change from baseline in mean diurnal IOP at Week 4 between treatment groups. The null hypothesis was that the mean diurnal IOP change at Week 4 for Group 1 was at least 1.5 mmHg greater than that for Group 2. The hypothesis was tested using a confidence interval approach based on a 2-way analysis of variance (ANOVA) model including factors for treatment and investigator.||0.57|-1.68|
72372153|NCT03630770|144254290|OTHER||Rate Ratio|0.98||||0.9|TWO_SIDED|95.0|0.55|1.7||p-values underwent generalized estimating equations adjustment for multiple measures per individuals within time.|Negative binomial regression|||Stool fungal counts (cfu/g) were compared between groups using negative binomial regression within time period (before, during, after). Rate ratio was calculated to reflect the direction and magnitude of change in stool colony counts between time periods (before v. during supplementation) for the control group.||1.7|0.55|0.9
72372154|NCT03630770|144254290|OTHER||Rate Ratio|8.1|||<|0.001|TWO_SIDED|95.0|2.6|25.0||p-values underwent generalized estimating equations adjustment for multiple measures per individuals within time.|Negative binomial regression|||Stool fungal counts (cfu/g) were compared between groups using negative binomial regression within time period (before, during, after). Rate ratio was calculated to reflect the direction and magnitude of change in stool colony counts between time periods (during v. after supplementation) for the control group.||25|2.6|<0.001
72493591|NCT00511355|144516382|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0016||95.0||||No correction for multiple testing was made.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for age class applied on the changes from baseline.||P-value compares the change from baseline to Cycle 6 between treatment groups.||||0.0016
72372155|NCT03630770|144254290|OTHER||Rate Ratio|0.15||||0.02|TWO_SIDED|95.0|0.03|0.75||p-values underwent generalized estimating equations adjustment for multiple measures per individuals within time.|Negative binomial regression|||Stool fungal counts (cfu/g) were compared between groups using negative binomial regression within time period (before, during, after). Rate ratio was calculated to reflect the direction and magnitude of change in stool colony counts between time periods (before v. during supplementation) for the MCT group.||0.75|0.03|0.02
72372156|NCT03630770|144254290|OTHER||Rate Ratio|61.0|||<|0.001|TWO_SIDED|95.0|6.9|533.0||p-values underwent generalized estimating equations adjustment for multiple measures per individuals within time.|Negative binomial regression|||Stool fungal counts (cfu/g) were compared between groups using negative binomial regression within time period (before, during, after). Rate ratio was calculated to reflect the direction and magnitude of change in stool colony counts between time periods (during v. after supplementation) for the MCT group.||533|6.9|<0.001
72372157|NCT01086358|144254291|SUPERIORITY||Mean Difference (Final Values)|-1.71||||0.007|TWO_SIDED|95.0|-2.92|-0.49|||Mixed Models Analysis|As noted above, results are adjusted for study period and treatment order||Analysis is a superiority comparison based on the use of linear mixed effect model with subject as a random effect, with treatment as the primary fixed effect and including study period and treatment order as other fixed effects.||-0.49|-2.92|0.007
72372158|NCT01086358|144254292|SUPERIORITY||Mean Difference (Final Values)|-1.03||||0.01|TWO_SIDED|95.0|-1.79|-0.27|||Mixed Models Analysis|As noted above, results are adjusted for study period and treatment order||Analysis is a superiority comparison based on the use of linear mixed effect model with subject as a random effect, with treatment as the primary fixed effect and including study period and treatment order as other fixed effects.||-0.27|-1.79|0.010
72372159|NCT01086358|144254293|SUPERIORITY||Mean Difference (Final Values)|-0.68||||0.059|TWO_SIDED|95.0|-1.39|0.03|||Mixed Models Analysis|As noted above, results are adjusted for study period and treatment order.||Analysis is a superiority comparison based on the use of linear mixed effect model with subject as a random effect, with treatment as the primary fixed effect and including study period and treatment order as other fixed effects.||0.03|-1.39|0.059
72493592|NCT00511355|144516383|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0003||95.0||||No correction for multiple testing was made.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for age class applied on the changes from baseline.||P-value compares the change from baseline to Cycle 6 between treatment groups.||||0.0003
72372160|NCT01086358|144254294|SUPERIORITY||Odds Ratio (OR)|2.89||||0.016|TWO_SIDED|95.0|1.22|6.84|||Regression, Logistic|As noted above, results are adjusted for study period and treatment order.||Logistic regression models with generalized estimating equations were used. In these models, a logit link function was used for a favorable response (yes/no) with treatment as the primary fixed effect and including study period and treatment order as other fixed effects..||6.84|1.22|0.016
72372161|NCT04975230|144254295|OTHER||Cohen's D|0.17|STANDARD_ERROR_OF_MEAN|0.17||0.0227|TWO_SIDED|95.0|-0.37|0.78|||Mixed Models Analysis|||||0.78|-0.37|0.0227
72372162|NCT02471612|144254303|SUPERIORITY_OR_OTHER_LEGACY|||||||0.665||||||Comparing the sensitivity of APACHE-II and P-POSSUM|McNemar|||"Area under the curve (AUC) is used to measure the size of the prediction composed by the graphic display between the 'sensitivity' and the '1-specificity' relationship. AUC can range from 0.5 to 1.0 and a result of 1.0 indicates a perfect discriminatory ability. An AUC value \> 0.8 is considered good, a range between 0.60-0.80 is considered as moderate, and an AUC value \< 0.60 is regarded as poor."||||0.665
72372163|NCT00984620|144254344|SUPERIORITY_OR_OTHER||Adjusted percent difference|-1.25||||0.855|TWO_SIDED|95.0|-14.3|11.8|||Cochran-Mantel-Haenszel|Based on an Cochran-Mantel-Haenszel method adjusted by HCV genotype (1a and 1b only).|p-value presented is 2-sided. The percent differences and p-values are based on a comparison to the Faldaprevir 120mg (12 Weeks).|||11.8|-14.3|0.855
72372164|NCT00984620|144254345|SUPERIORITY_OR_OTHER||Adjusted percent difference|9.02||||0.229|TWO_SIDED|95.0|-5.3|23.3|||Cochran-Mantel-Haenszel|Based on an Cochran-Mantel-Haenszel method adjusted by HCV genotype (1a and 1b only).|p-value presented is 2-sided. The percent differences and p-values are based on a comparison to the Faldaprevir 120mg (12 Weeks).|||23.3|-5.3|0.229
72372165|NCT00984620|144254346|SUPERIORITY_OR_OTHER||Adjusted percent difference|5.48||||0.417|TWO_SIDED|95.0|-7.3|18.3|||Cochran-Mantel-Haenszel|Based on an Cochran-Mantel-Haenszel method adjusted by HCV genotype (1a and 1b only).|p-value presented is 2-sided. The percent differences and p-values are based on a comparison to the Faldaprevir 120mg (12 Weeks).|||18.3|-7.3|0.417
72372166|NCT00984620|144254347|SUPERIORITY_OR_OTHER||Adjusted percent difference|2.99||||0.676|TWO_SIDED|95.0|-10.6|16.6|||Cochran-Mantel-Haenszel|Based on an Cochran-Mantel-Haenszel method adjusted by HCV genotype (1a and 1b only).|p-value presented is 2-sided. The percent differences and p-values are based on a comparison to the Faldaprevir 120mg (12 Weeks).|||16.6|-10.6|0.676
72372167|NCT00984620|144254348|SUPERIORITY_OR_OTHER||Adjusted percent difference|3.24||||0.588|TWO_SIDED|95.0|-8.1|14.6|||Cochran-Mantel-Haenszel|Based on an Cochran-Mantel-Haenszel method adjusted by HCV genotype (1a and 1b only).|p-value presented is 2-sided. The percent differences and p-values are based on a comparison to the Faldaprevir 120mg (12 Weeks).|||14.6|-8.1|0.588
72372168|NCT00984620|144254349|SUPERIORITY_OR_OTHER||Adjusted percent difference|4.78||||0.512|TWO_SIDED|95.0|-9.0|18.6|||Cochran-Mantel-Haenszel|Based on an Cochran-Mantel-Haenszel method adjusted by HCV genotype (1a and 1b only).|p-value presented is 2-sided. The percent differences and p-values are based on a comparison to the Faldaprevir 120mg (12 Weeks).|||18.6|-9.0|0.512
72372169|NCT00984620|144254351|SUPERIORITY_OR_OTHER|||||||0.1397||||||Compare 120 MG Faldaprevir 120mg (24 Weeks) over 120 MG Faldaprevir 120mg (12 Weeks) using log-rank test.|Log Rank|||||||0.1397
72372170|NCT00470834|144254386|SUPERIORITY_OR_OTHER|||||||0.79||95.0|||||Log Rank|||||||0.79
72372171|NCT00470834|144254386|SUPERIORITY_OR_OTHER||Relative Risk|0.94|||||TWO_SIDED|95.0|0.61|1.46|||||The hazard ratio is based on the Cox proportional hazards model.|||1.46|0.61|
72372172|NCT00470834|144254386|SUPERIORITY_OR_OTHER||Relative Risk Reduction|5.62|||||TWO_SIDED|95.0|-46.14|39.05|||||Relative Risk Reduction = 100 \* (1 - Relative Risk).|||39.05|-46.14|
72372173|NCT00244140|144254391|SUPERIORITY_OR_OTHER||Percent Images Rated Good/Excellent: BR1|95.8||||||95.0|93.3|97.6||||||Study was uncontrolled - No comparison between groups. The 95% Confidence Interval (CI) were calculated for each of the 3 blinded readers separately. This analysis refers to the assessment of blinded reader 1 (BR1).||97.6|93.3|
72372174|NCT00244140|144254391|SUPERIORITY_OR_OTHER||Percent Images Rated Good/Excellent: BR2|96.3||||||95.0|93.9|98.0||||||Study was uncontrolled - No comparison between groups. The 95% Confidence Interval (CI) were calculated for each of the 3 blinded readers separately. This analysis refers to the assessment of blinded reader 2 (BR2).||98.0|93.9|
72372175|NCT00244140|144254391|SUPERIORITY_OR_OTHER||Percent Images Rated Good/Excellent: BR3|98.4||||||95.0|96.6|99.4||||||Study was uncontrolled - No comparison between groups. The 95% Confidence Interval (CI) were calculated for each of the 3 blinded readers separately. This analysis refers to the assessment of blinded reader 3 (BR3).||99.4|96.6|
72372176|NCT00244140|144254392|SUPERIORITY_OR_OTHER||Percent Images Rated Yes|99.7||||||95.0|98.6|100.0||||||||100.0|98.6|
72372177|NCT00244140|144254393|SUPERIORITY_OR_OTHER||Percent Images Rated Good/Excellent|99.5||||||95.0|98.1|99.9||||||||99.9|98.1|
72372178|NCT00244140|144254394|SUPERIORITY_OR_OTHER||Percent Images Rated Yes: BR1|98.4||||||95.0|96.6|99.4||||||Study was uncontrolled - No comparison between groups. The 95% Confidence Interval (CI) were calculated for each of the 3 blinded readers separately. This analysis refers to the assessment of blinded reader 1 (BR1).||99.4|96.6|
72372179|NCT00244140|144254394|SUPERIORITY_OR_OTHER||Percent Images Rated Yes: BR2|100.0||||||95.0|99.0|100.0||||||Study was uncontrolled - No comparison between groups. The 95% Confidence Interval (CI) were calculated for each of the 3 blinded readers separately. This analysis refers to the assessment of blinded reader 2 (BR2).||100.0|99.0|
72372180|NCT00244140|144254394|SUPERIORITY_OR_OTHER||Percent Images Rated Yes: BR3|99.7||||||95.0|98.6|100.0||||||Study was uncontrolled - No comparison between groups. The 95% Confidence Interval (CI) were calculated for each of the 3 blinded readers separately. This analysis refers to the assessment of blinded reader 3 (BR3).||100.0|98.6|
72372181|NCT02365480|144254413|OTHER||Odds Ratio (OR)|1.91||||0.6|TWO_SIDED|95.0|0.1|36.37|||Fisher Exact|||||36.37|0.10|0.60
72372182|NCT02791763|144254418|NON_INFERIORITY|Non-inferiority was to be established as the lower limit of the 95% confidence interval (CI) for the treatment difference was greater than the pre-specified non-inferiority margin (-1.0 g/dL).|Median Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.088|<|0.0001|TWO_SIDED|95.0|-0.07|0.28||The p value on this table is one-sided and calculated for the non-inferiority assessment.|Mixed model repeated measures (MMRM)||Analysis was performed by a MMRM with covariates of treatment, Baseline Hgb, visit, treatment-by-visit interaction and Baseline-by-visit interaction.|||0.28|-0.07|<.0001
72372183|NCT02791763|144254419|SUPERIORITY||Odds Ratio (OR)|1.01||||0.4941|TWO_SIDED|95.0|0.33|3.04||The p value on this table is one-sided and calculated for the superiority assessment.|Regression, Logistic||Analysis was performed by logistic regression with covariates of treatment, Baseline Hgb, and Baseline ESA use.|||3.04|0.33|0.4941
72372184|NCT02791763|144254420|SUPERIORITY||Odds Ratio (OR)|1.01||||0.4941|TWO_SIDED|95.0|0.33|3.04||The p value on this table is one-sided and calculated for the superiority assessment.|Regression, Logistic||Analysis was performed by logistic regression with covariates of treatment, Baseline Hgb, and Baseline ESA use.|||3.04|0.33|0.4941
72372185|NCT02428478|144254534|OTHER|||||||0.01||||||P\<0.05 considered statistically significant|Wilcoxon Matched-Pairs Signed-Rank Test|||Tonic analysis||||0.01
72372186|NCT02428478|144254534|OTHER|||||||0.38||||||P\<0.05 considered statistically significant|Wilcoxon Matched-Pairs Signed-Rank Test|||Phasic analysis||||0.38
72372187|NCT02428478|144254535|OTHER||Median Change|-0.6||||0.037|TWO_SIDED||||||Wilcoxon Matched-Pairs Signed-Rank Test|||Passive Pcrit||||0.037
72372188|NCT02428478|144254535|OTHER||||||>|0.5|||||||Wilcoxon Matched-Pairs Signed-Rank Test|||Active Pcrit||||>0.5
72372189|NCT02663934|144254536|SUPERIORITY||Mean Difference (Net)|0.15||||0.31|TWO_SIDED|95.0|0.05|0.25|||ANOVA|||||.25|.05|0.31
72372190|NCT02663934|144254537|SUPERIORITY||Mean Difference (Net)|1.42||||0.24|TWO_SIDED||||||ANOVA|||Change in Global CBF in EXS vs. SIS||||.24
72372191|NCT02663934|144254537|OTHER||Slope|0.41||||0.02|ONE_SIDED|95.0|||||Regression, Linear|||Change in Strength \& Change in Frontal Brain Volume in EXS||||.02
72372192|NCT02663934|144254537|OTHER||Slope|0.4||||0.02|ONE_SIDED|95.0|||||Regression, Linear|||Changes in Brain Volumes associated with changes Memory Performance in EXS||||0.02
72372193|NCT02663934|144254538|OTHER||Slope|0.47||||0.005|ONE_SIDED|95.0|||||Regression, Linear|||Increases in Time Spent in MVPA and Increased Learning Performance in EXS||||.005
72372194|NCT02692391|144254551|SUPERIORITY|||||||0.87|||||||Wilcoxon (Mann-Whitney)|||||||0.87
72372195|NCT02692391|144254552|SUPERIORITY|||||||0.48|||||||Wilcoxon (Mann-Whitney)|||||||0.48
72372196|NCT02692391|144254553|SUPERIORITY|||||||0.71|||||||Fisher Exact|||||||0.71
72372197|NCT02692391|144254554|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.00
72372198|NCT01510769|144254564|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.1||||0.1298|TWO_SIDED|95.0|-0.03|0.23|||Cochran-Mantel-Haenszel|||||0.23|-0.03|0.1298
72372199|NCT01510769|144254564|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.29|||<|0.0001|TWO_SIDED|95.0|0.17|0.42|||Cochran-Mantel-Haenszel|||||0.42|0.17|<0.0001
72372200|NCT01510769|144254565|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.04||||0.4453|TWO_SIDED|95.0|-0.07|0.16|||Cochran-Mantel-Haenszel|||||0.16|-0.07|0.4453
72372201|NCT01510769|144254565|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.09||||0.1149|TWO_SIDED|95.0|-0.02|0.21|||Cochran-Mantel-Haenszel|||||0.21|-0.02|0.1149
72372202|NCT01510769|144254566|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.03||||0.645|TWO_SIDED|95.0|-0.1|0.17|||Cochran-Mantel-Haenszel|||||0.17|-0.10|0.6450
72372203|NCT01510769|144254566|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.06||||0.4118|TWO_SIDED|95.0|-0.08|0.19|||Cochran-Mantel-Haenszel|||||0.19|-0.08|0.4118
72372204|NCT01510769|144254567|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.08||||0.3034|TWO_SIDED|95.0|-0.24|0.07|||Cochran-Mantel-Haenszel|||||0.07|-0.24|0.3034
72372205|NCT01510769|144254567|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.19||||0.021|TWO_SIDED|95.0|-0.34|-0.04|||Cochran-Mantel-Haenszel|||||-0.04|-0.34|0.0210
72372206|NCT01980485|144254568|NON_INFERIORITY_OR_EQUIVALENCE|This study had 87% power to detect a 40% increase in 28-dayabstinence rates (i.e., from 50% to 70%) based on a two-tailed chi-squared test and alpha = 0.05. We selected this effect size as being at the lower end of the effect size continuum that would be clinically meaningful at 28 days and have the potential to still be meaningful in the longer term even with similar relapse rates in both groups over subsequent months.||||||0.65|||||||Chi-squared|||||||.65
72372207|NCT00744042|144254582|SUPERIORITY_OR_OTHER|||||||0.0039|TWO_SIDED|||||Testing whether median change in rickets severity from Baseline to Week 24, measured by RGI-C at Week 24, is from zero.|Wilcoxon signed-rank test|The last post-baseline observation carry forward method is used; patients with no post-baseline assessments were imputed as having no change.||One treatment group||||0.0039
72372208|NCT03158285|144254600|SUPERIORITY||Difference in percentage|31.2|||<|0.001|TWO_SIDED|95.0|22.9|39.5|||Cochran-Mantel-Haenszel|||||39.5|22.9|< 0.001
72372209|NCT03158285|144254600|SUPERIORITY||Difference in percentage|30.8|||<|0.001|TWO_SIDED|95.0|22.4|39.1|||Cochran-Mantel-Haenszel|||||39.1|22.4|< 0.001
72372210|NCT03158285|144254601|SUPERIORITY||Least Square (LS) Mean difference|-0.2372|||<|0.001|TWO_SIDED|95.0|-0.321|-0.1534|||ANCOVA|||||-0.1534|-0.3210|< 0.001
72372211|NCT03158285|144254601|SUPERIORITY||LS Mean difference|-0.2704|||<|0.001|TWO_SIDED|95.0|-0.3544|-0.1864|||ANCOVA|||||-0.1864|-0.3544|< 0.001
72372212|NCT03158285|144254602|SUPERIORITY||Difference in percentage|17.2|||<|0.001||95.0|10.0|24.4||Nominal|Cochran-Mantel-Haenszel|||||24.4|10.0|< 0.001
72372213|NCT03158285|144254602|SUPERIORITY||Difference in percentage|18.8|||<|0.001|TWO_SIDED|95.0|11.5|26.1||Nominal|Cochran-Mantel-Haenszel|||||26.1|11.5|< 0.001
72372214|NCT03158285|144254603|SUPERIORITY||Difference in percentage|50.9|||<|0.001|TWO_SIDED|95.0|42.2|59.7|||Cochran-Mantel-Haenszel|||||59.7|42.2|<0.001
72372215|NCT03158285|144254603|SUPERIORITY||Difference in percentage|49.8|||<|0.001|TWO_SIDED|95.0|41.2|58.4|||Cochran-Mantel-Haenszel|||||58.4|41.2|< 0.001
72372216|NCT03158285|144254604|SUPERIORITY||Difference in percentage|21.5|||<|0.001|TWO_SIDED|95.0|13.1|30.0||Nominal|Cochran-Mantel-Haenszel|||||30.0|13.1|< 0.001
72372217|NCT03158285|144254604|SUPERIORITY||Difference in percentage|22.2|||<|0.001|TWO_SIDED|95.0|13.7|30.7||Nominal|Cochran-Mantel-Haenszel|||||30.7|13.7|< 0.001
72372218|NCT03158285|144254605|SUPERIORITY||LS Mean difference|-0.43||||0.072|TWO_SIDED|95.0|-0.9|0.03|||ANCOVA|||||0.03|-0.90|0.072
72372219|NCT03158285|144254605|SUPERIORITY||LS Mean difference|-0.66||||0.011|TWO_SIDED|95.0|-1.13|-0.19|||ANCOVA|||||-0.19|-1.13|0.011
72372220|NCT03158285|144254606|SUPERIORITY||Difference in response rates|20.1||||0.03|TWO_SIDED|95.0|11.8|28.5|||Cochran-Mantel-Haenszel|||||28.5|11.8|0.030
72372221|NCT03158285|144254606|SUPERIORITY||Difference in response rates|14.6||||0.03|TWO_SIDED|95.0|6.4|22.7|||Cochran-Mantel-Haenszel|||||22.7|6.4|0.030
72372222|NCT03158285|144254607|SUPERIORITY||Difference in response rates|18.0||||0.03|TWO_SIDED|95.0|7.4|28.6|||Cochran-Mantel-Haenszel|||||28.6|7.4|0.030
72372223|NCT03158285|144254607|SUPERIORITY||Difference in response rates|21.3||||0.011|TWO_SIDED|95.0|10.5|32.0|||Cochran-Mantel-Haenszel|||||32.0|10.5|0.011
72372224|NCT03158285|144254608|SUPERIORITY||LS Mean Difference|-0.5|||<|0.001|TWO_SIDED|95.0|-0.77|-0.23||Nominal|ANCOVA|||||-0.23|-0.77|< 0.001
72372225|NCT03158285|144254608|SUPERIORITY||LS Mean Difference|-0.57|||<|0.001|TWO_SIDED|95.0|-0.83|-0.31||Nominal|ANCOVA|||||-0.31|-0.83|< 0.001
72372226|NCT03158285|144254609|SUPERIORITY||LS Mean Difference|-1.89|||<|0.001|TWO_SIDED|95.0|-2.99|-0.79||Nominal|ANCOVA|||||-0.79|-2.99|< 0.001
72372227|NCT03158285|144254609|SUPERIORITY||LS Mean Difference|-1.77||||0.002|TWO_SIDED|95.0|-2.87|-0.66||Nominal|ANCOVA|||||-0.66|-2.87|0.002
72372228|NCT03158285|144254610|SUPERIORITY||LS Mean difference|3.97||||0.011|TWO_SIDED|95.0|2.75|5.2|||ANCOVA|||||5.20|2.75|0.011
72372229|NCT03158285|144254610|SUPERIORITY||LS Mean difference|3.62||||0.011|TWO_SIDED|95.0|2.39|4.85|||ANCOVA|||||4.85|2.39|0.011
72372230|NCT03158285|144254611|SUPERIORITY||LS Mean difference|-0.61|||<|0.001|TWO_SIDED|95.0|-0.8|-0.43||Nominal|ANCOVA|||||-0.43|-0.80|< 0.001
72372231|NCT03158285|144254611|SUPERIORITY||LS Mean difference|-0.65|||<|0.001|TWO_SIDED|95.0|-0.83|-0.47||Nominal|ANCOVA|||||-0.47|-0.83|< 0.001
72372232|NCT03158285|144254612|SUPERIORITY||LS Mean difference|2.02||||0.072|TWO_SIDED|95.0|0.56|3.49|||ANCOVA|||||3.49|0.56|0.072
72372233|NCT03158285|144254612|SUPERIORITY||LS Mean difference|2.07||||0.072|TWO_SIDED|95.0|0.6|3.54|||ANCOVA|||||3.54|0.60|0.072
72372234|NCT03158285|144254613|SUPERIORITY||Difference in percentage|19.3|||<|0.001|TWO_SIDED|95.0|12.6|25.9||Nominal|Cochran-Mantel-Haenszel|||||25.9|12.6|< 0.001
72372235|NCT03158285|144254613|SUPERIORITY||Difference in percentage|11.5|||<|0.001|TWO_SIDED|95.0|5.2|17.7||Nominal|Cochran-Mantel-Haenszel|||||17.7|5.2|< 0.001
72372236|NCT03158285|144254614|SUPERIORITY||Difference in percentage|14.5|||<|0.001|TWO_SIDED|95.0|9.1|19.9||Nominal|Cochran-Mantel-Haenszel|||||19.9|9.1|< 0.001
72372237|NCT03158285|144254614|SUPERIORITY||Difference in percentage|9.0|||<|0.001|TWO_SIDED|95.0|4.1|13.8||Nominal|Cochran-Mantel-Haenszel|||||13.8|4.1|< 0.001
72372238|NCT01818752|144254817|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.906||||0.159|TWO_SIDED|95.0|0.746|1.101||The p-value boundary for PFS analysis was 0.02141.|Log Rank|Log-rank p-value (1-sided) stratified by ISS stage, choice of route of bortezomib administration, region and age.|The hazard ratio (Carfilzomib/Bortezomib) was estimated using a Cox proportional hazards model stratified by ISS stage, choice of route of bortezomib administration, region and age.|The inferential test associated with the primary analysis of PFS was assessed against an overall 1-sided significance level of α=0.025.||1.101|0.746|0.1590
72493593|NCT00511355|144516384|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0009||95.0||||No correction for multiple testing was made.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for age class applied on the changes from baseline.||P-value compares the change from baseline to Cycle 6 between treatment groups.||||0.0009
72372239|NCT01818752|144254818|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.211||||0.8934|TWO_SIDED|95.0|0.896|1.637||Based on the pre-specified multiplicity adjustment method, secondary endpoints were to be tested only if the results of the primary endpoint were significant. The p-values for all secondary endpoints are descriptive only.|Log Rank|Log-rank p-value (1-sided) stratified by ISS stage, choice of route of bortezomib administration, region and age.|The hazard ratio (Carfilzomib/Bortezomib) was estimated using a Cox proportional hazards model stratified by ISS stage, choice of route of bortezomib administration, region and age.|||1.637|0.896|0.8934
72372240|NCT01818752|144254819|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.412||||0.0218|TWO_SIDED|95.0|1.01|1.973||Based on the pre-specified multiplicity adjustment method, secondary endpoints were to be tested only if the results of the primary endpoint were significant. The p-values for all secondary endpoints are descriptive only.|Stratified Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel Chi-square test stratified by ISS stage, choice of route of bortezomib administration, region and age.|Odds ratio (Carfilzomib/Bortezomib) was estimated using the Mantel-Haenszel method stratified by ISS stage, choice of route of bortezomib administration, region and age.|||1.973|1.010|0.0218
72372241|NCT01818752|144254820|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.179||||0.1388|TWO_SIDED|95.0|0.875|1.589||Based on the pre-specified multiplicity adjustment method, secondary endpoints were to be tested only if the results of the primary endpoint were significant. The p-values for all secondary endpoints are descriptive only.|Stratified Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel Chi-square test stratified by ISS stage, choice of route of bortezomib administration, region and age.|Odds ratio (Carfilzomib/Bortezomib) was estimated using the Mantel-Haenszel method stratified by ISS stage, choice of route of bortezomib administration, region and age.|||1.589|0.875|0.1388
72372242|NCT01818752|144254821|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.048|||<|0.0001|TWO_SIDED|95.0|0.026|0.088||Based on the pre-specified multiplicity adjustment method, secondary endpoints were to be tested only if the results of the primary endpoint were significant. The p-values for all secondary endpoints are descriptive only.|Pearson Chi-Square test||Unstratified odds ratio (Carfilzomib/Bortezomib) was estimated.|||0.088|0.026|< 0.0001
72372243|NCT01818752|144254822|SUPERIORITY_OR_OTHER||Least squares mean difference|4.99|STANDARD_ERROR_OF_MEAN|0.773|<|0.0001|TWO_SIDED|95.0|3.48|6.51||Based on the pre-specified multiplicity adjustment method, secondary endpoints were to be tested only if the results of the primary endpoint were significant. The p-values for all secondary endpoints are descriptive only.|Mixed Effects Model for Repeated Measure|||Treatment groups were compared using a linear mixed model for repeated measures (MMRM). The model included the fixed, categorical effects of treatment (all baseline responses were modeled with a dummy treatment), the randomization stratification factors - ISS stage, choice of route of bortezomib administration, region, age, and random effects of subject intercept and coefficient on time.||6.51|3.48|< 0.0001
72372244|NCT03060551|144254836|OTHER|Because most efficacy data consisted of non-parameteric variables, results were shown as median values and interquartile range. The Wilcoxon signed-rank test was performed to analyze differences between baseline and at 2W, 6W, 12W and 24W, respectively, using IBM-SPSS Statistics version 24.0 (SPSS Inc., Chicago, IL, USA). Statistical significance was considered at p \< 0.05. Safety profiles were descriptively analyzed.||||||0.256||||||p value (24 weeks-baseline)|Wilcoxon (Mann-Whitney)|||||||0.256
72372245|NCT03060551|144254837|OTHER|Because most efficacy data consisted of non-parameteric variables, results were shown as median values and interquartile range. The Wilcoxon signed-rank test was performed to analyze differences between baseline and at 2W, 6W, 12W and 24W, respectively, using IBM-SPSS Statistics version 24.0 (SPSS Inc., Chicago, IL, USA). Statistical significance was considered at p \< 0.05. Safety profiles were descriptively analyzed.||||||0.682||||||p-value (24 weeks-baseline)|Wilcoxon (Mann-Whitney)|||||||0.682
72372246|NCT03060551|144254838|OTHER|Because most efficacy data consisted of non-parameteric variables, results were shown as median values and interquartile range. The Wilcoxon signed-rank test was performed to analyze differences between baseline and at 2W, 6W, 12W and 24W, respectively, using IBM-SPSS Statistics version 24.0 (SPSS Inc., Chicago, IL, USA). Statistical significance was considered at p \< 0.05. Safety profiles were descriptively analyzed.||||||0.151||||||p-value (24 weeks-baseline)|Wilcoxon (Mann-Whitney)|||||||0.151
72372247|NCT03060551|144254839|OTHER|Because most efficacy data consisted of non-parameteric variables, results were shown as median values and interquartile range. The Wilcoxon signed-rank test was performed to analyze differences between baseline and at 2W, 6W, 12W and 24W, respectively, using IBM-SPSS Statistics version 24.0 (SPSS Inc., Chicago, IL, USA). Statistical significance was considered at p \< 0.05. Safety profiles were descriptively analyzed.||||||0.516||||||p-value (24 weeks-baseline)|Wilcoxon (Mann-Whitney)|||||||0.516
72372248|NCT03060551|144254840|OTHER|Because most efficacy data consisted of non-parameteric variables, results were shown as median values and interquartile range. The Wilcoxon signed-rank test was performed to analyze differences between baseline and at 2W, 6W, 12W and 24W, respectively, using IBM-SPSS Statistics version 24.0 (SPSS Inc., Chicago, IL, USA). Statistical significance was considered at p \< 0.05. Safety profiles were descriptively analyzed.|||||>|0.999||||||p-value (24 weeks-baseline)|Wilcoxon (Mann-Whitney)|||||||>0.999
72372249|NCT03060551|144254841|OTHER|Because most efficacy data consisted of non-parameteric variables, results were shown as median values and interquartile range. The Wilcoxon signed-rank test was performed to analyze differences between baseline and at 2W, 6W, 12W and 24W, respectively, using IBM-SPSS Statistics version 24.0 (SPSS Inc., Chicago, IL, USA). Statistical significance was considered at p \< 0.05. Safety profiles were descriptively analyzed.||||||0.034||||||p-value (24 weeks-baseline)|Wilcoxon (Mann-Whitney)|||||||0.034
72372250|NCT03060551|144254842|OTHER|Because most efficacy data consisted of non-parameteric variables, results were shown as median values and interquartile range. The Wilcoxon signed-rank test was performed to analyze differences between baseline and at 2W, 6W, 12W and 24W, respectively, using IBM-SPSS Statistics version 24.0 (SPSS Inc., Chicago, IL, USA). Statistical significance was considered at p \< 0.05. Safety profiles were descriptively analyzed.||||||0.656||||||p-value (24 weeks-baseline)|Wilcoxon (Mann-Whitney)|||||||0.656
72372251|NCT03060551|144254843|OTHER|Because most efficacy data consisted of non-parameteric variables, results were shown as median values and interquartile range. The Wilcoxon signed-rank test was performed to analyze differences between baseline and at 2W, 6W, 12W and 24W, respectively, using IBM-SPSS Statistics version 24.0 (SPSS Inc., Chicago, IL, USA). Statistical significance was considered at p \< 0.05. Safety profiles were descriptively analyzed.||||||0.096||||||p-value (24 weeks-baseline)|Wilcoxon (Mann-Whitney)|||||||0.096
72372252|NCT03060551|144254844|OTHER|Because most efficacy data consisted of non-parameteric variables, results were shown as median values and interquartile range. The Wilcoxon signed-rank test was performed to analyze differences between baseline and at 2W, 6W, 12W and 24W, respectively, using IBM-SPSS Statistics version 24.0 (SPSS Inc., Chicago, IL, USA). Statistical significance was considered at p \< 0.05. Safety profiles were descriptively analyzed.||||||0.019||||||p-value (24 weeks-baseline)|Wilcoxon (Mann-Whitney)|||||||0.019
72372253|NCT03060551|144254845|OTHER|Because most efficacy data consisted of non-parameteric variables, results were shown as median values and interquartile range. The Wilcoxon signed-rank test was performed to analyze differences between baseline and at 2W, 6W, 12W and 24W, respectively, using IBM-SPSS Statistics version 24.0 (SPSS Inc., Chicago, IL, USA). Statistical significance was considered at p \< 0.05. Safety profiles were descriptively analyzed.||||||0.05||||||p-value (24 weeks-baseline)|Wilcoxon (Mann-Whitney)|||||||0.050
72372254|NCT03060551|144254846|OTHER|Because most efficacy data consisted of non-parameteric variables, results were shown as median values and interquartile range. The Wilcoxon signed-rank test was performed to analyze differences between baseline and at 2W, 6W, 12W and 24W, respectively, using IBM-SPSS Statistics version 24.0 (SPSS Inc., Chicago, IL, USA). Statistical significance was considered at p \< 0.05. Safety profiles were descriptively analyzed.||||||0.372||||||p-value (24 weeks-baseline)|Wilcoxon (Mann-Whitney)|||||||0.372
72372255|NCT03060551|144254847|OTHER|Because most efficacy data consisted of non-parameteric variables, results were shown as median values and interquartile range. The Wilcoxon signed-rank test was performed to analyze differences between baseline and at 2W, 6W, 12W and 24W, respectively, using IBM-SPSS Statistics version 24.0 (SPSS Inc., Chicago, IL, USA). Statistical significance was considered at p \< 0.05. Safety profiles were descriptively analyzed.||||||0.024||||||p-value (24 weeks-baseline)|Wilcoxon (Mann-Whitney)|||||||0.024
72372256|NCT03060551|144254848|OTHER|Because most efficacy data consisted of non-parameteric variables, results were shown as median values and interquartile range. The Wilcoxon signed-rank test was performed to analyze differences between baseline and at 2W, 6W, 12W and 24W, respectively, using IBM-SPSS Statistics version 24.0 (SPSS Inc., Chicago, IL, USA). Statistical significance was considered at p \< 0.05. Safety profiles were descriptively analyzed.||||||0.188||||||p-value (24 weeks-baseline)|Wilcoxon (Mann-Whitney)|||||||0.188
72372257|NCT03060551|144254849|OTHER|Because most efficacy data consisted of non-parameteric variables, results were shown as median values and interquartile range. The Wilcoxon signed-rank test was performed to analyze differences between baseline and at 2W, 6W, 12W and 24W, respectively, using IBM-SPSS Statistics version 24.0 (SPSS Inc., Chicago, IL, USA). Statistical significance was considered at p \< 0.05. Safety profiles were descriptively analyzed.||||||0.372||||||p-value (24 weeks-baseline)|Wilcoxon (Mann-Whitney)|||||||0.372
72372258|NCT03060551|144254850|OTHER|Because most efficacy data consisted of non-parameteric variables, results were shown as median values and interquartile range. The Wilcoxon signed-rank test was performed to analyze differences between baseline and at 2W, 6W, 12W and 24W, respectively, using IBM-SPSS Statistics version 24.0 (SPSS Inc., Chicago, IL, USA). Statistical significance was considered at p \< 0.05. Safety profiles were descriptively analyzed.||||||0.633||||||p-value (24 weeks-baseline)|Wilcoxon (Mann-Whitney)|||||||0.633
72372259|NCT03060551|144254851|OTHER|Because most efficacy data consisted of non-parameteric variables, results were shown as median values and interquartile range. The Wilcoxon signed-rank test was performed to analyze differences between baseline and at 2W, 6W, 12W and 24W, respectively, using IBM-SPSS Statistics version 24.0 (SPSS Inc., Chicago, IL, USA). Statistical significance was considered at p \< 0.05. Safety profiles were descriptively analyzed.||||||0.38||||||p-value (24 weeks-baseline)|Wilcoxon (Mann-Whitney)|||||||0.380
72372260|NCT03009396|144254885|SUPERIORITY|||||||0.2112|||||||Log Rank|||||||0.2112
72372261|NCT03009396|144254886|SUPERIORITY|||||||0.0356|||||||Log Rank|||||||0.0356
72372262|NCT03009396|144254887|SUPERIORITY|||||||0.0514|||||||Log Rank|||||||0.0514
72372263|NCT03009396|144254888|SUPERIORITY|||||||0.1259|||||||Log Rank|||||||0.1259
72372264|NCT03009396|144254889|SUPERIORITY|||||||0.4114|||||||Fisher Exact|||||||0.4114
72372265|NCT01808092|144254901|NON_INFERIORITY_OR_EQUIVALENCE|The statistical test of NI for the primary efficacy analysis will be performed at the 2.5% 1 sided significance level. This test will be based on the lower limit of a 2-sided 95% confidence interval (CI). Consistent with the protocol, NI will be concluded if the lower limit of the 95% CI is greater than -12.5%.|percentage: units for RD are %|-4.2||||0.007|TWO_SIDED|95.0|-10.76|2.46||P-value for 1-sided test at test of cure (TOC) with a -12.5% non-inferiority margin, i.e. H0: diff \<= -12.5%.|% Risk Difference (RD)|RD is CAZ-AVI clinical cure rate minus Meropenem clinical cure rate. The CI was calculated by Miettinen and Nurminen method without adjustment.||Statistical analysis for the proportion of patients with clinical cure at TOC in cMITT analysis set||2.46|-10.76|0.007
72372266|NCT01808092|144254902|NON_INFERIORITY_OR_EQUIVALENCE|The statistical test of NI for the primary efficacy analysis will be performed at the 2.5% 1 sided significance level. This test will be based on the lower limit of a 2-sided 95% confidence interval (CI). Consistent with the protocol, NI will be concluded if the lower limit of the 95% CI is greater than -12.5%.|percentage: units for RD are %|-0.7|||<|0.001|TWO_SIDED|95.0|-7.86|6.39||P-value for 1-sided test at test of cure (TOC) with a -12.5% non-inferiority margin, i.e. H0: diff \<= -12.5%.|% Risk Difference (RD)|RD is CAZ-AVI clinical cure rate minus Meropenem clinical cure rate. The CI was calculated by Miettinen and Nurminen method without adjustment.||Statistical analysis for the proportion of patients with clinical cure at TOC in CE at TOC analysis set||6.39|-7.86|<0.001
72372267|NCT03952039|144254950|SUPERIORITY||Difference in Proportion|29.6|||<|0.0001|TWO_SIDED|95.0|19.9|39.4|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test using the Greenland and Robins method to adjust for stratification factors: spleen size by palpation and platelet counts.||Stratified analysis (based on CRF)||39.4|19.9|<0.0001
72372268|NCT03952039|144254951|SUPERIORITY|Stratified analysis (based on CRF)|Difference in Proportion|17.1||||0.0033|TWO_SIDED|95.0|4.8|29.4|||Cochran-Mantel-Haenszel|CMH test using the Greenland and Robins method to adjust for stratification factors: spleen size by palpation and platelet counts.||||29.4|4.8|0.0033
72372269|NCT03952039|144254952|SUPERIORITY||Difference in Proportion|33.5|||<|0.0001|TWO_SIDED|95.0|21.9|45.1|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test using the Greenland and Robins method to adjust for stratification factors: spleen size by palpation and platelet counts.||Stratified analysis (based on CRF)||45.1|21.9|<0.0001
72372270|NCT03952039|144254955|SUPERIORITY||Greenland and Robins method|19.9|||||TWO_SIDED|95.0|10.0|29.7|||Greenland and Robins method|||||29.7|10.0|
72372271|NCT03703297|144254972|SUPERIORITY||Hazard Ratio (HR)|0.76||||0.01608|TWO_SIDED|95.0|0.606|0.95|||Log Rank|The analysis was performed using the stratified log-rank test.|Hazard ratio and CI calculated using stratified Cox proportional hazards model,adjusting for tumor,node and metastasis(TNM) stage, receipt of prophylactic cranial irradiation(PCI),with treatment as only covariate and ties handled by Efron approach.|||0.950|0.606|0.01608
72372272|NCT03703297|144254973|SUPERIORITY||Hazard Ratio (HR)|0.73||||0.01042|TWO_SIDED|95.0|0.569|0.928|||Log Rank|The analysis was performed using the stratified log-rank test.|Hazard ratio and CI were calculated using stratified Cox proportional hazards model, adjusting for receipt of PCI, with treatment as only covariate and ties handled by Efron approach.|||0.928|0.569|0.01042
72372273|NCT03844945|144254997|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
72372274|NCT01043939|144254998|SUPERIORITY_OR_OTHER||Difference of least square means|-0.16||||0.25|TWO_SIDED|95.0|-0.42|0.11||24 participants required to achieve 80% power to detect mean difference of 0.3 in RH-PAT index score between juice groups, assuming standard deviation of the difference was 0.25, using a two-sided significance level of 0.05|Mixed Models Analysis|Mixed effects ANCOVA model with baseline included as a covariate, subject as a random effect; juice, period \& group as fixed effects.|The a priori threshold for statistical significance was 0.05.|||0.11|-0.42|0.25
72372275|NCT01043939|144254999|SUPERIORITY_OR_OTHER||Difference of least square means|3.09||||0.29|TWO_SIDED|95.0|-2.73|8.91|||Mixed Models Analysis|Mixed effects ANCOVA model with baseline included as a covariate, subject as a random effect; juice, period \& group as fixed effects.||||8.91|-2.73|0.29
72372276|NCT01043939|144255000|SUPERIORITY_OR_OTHER||Ratio of means|0.92||||0.15|TWO_SIDED|95.0|0.82|1.03|||Mixed Models Analysis|Mixed effects ANCOVA model with baseline included as a covariate, subject as a random effect; juice, period \& group as fixed effects.|MPO was log transformed prior to analyses; the difference of log-transformed least square means (95% CI) were back-transformed to obtain the ratio of the means (95% CI).|||1.03|0.82|0.15
72372277|NCT01043939|144255001|SUPERIORITY_OR_OTHER||Ratio of means|1.34||||0.37|TWO_SIDED|95.0|0.69|2.62|||Mixed Models Analysis|Mixed effects ANCOVA model with baseline included as a covariate, subject as a random effect; juice, period \& group as fixed effects.|hs-CRP was log transformed prior to analyses; the difference of log-transformed least square means (95% CI) were back-transformed to obtain the ratio of the means (95% CI).|||2.62|0.69|0.37
72372278|NCT04473235|144255002|SUPERIORITY||Mean Difference (Final Values)|-0.799|STANDARD_ERROR_OF_MEAN|1.3||0.531|TWO_SIDED||||||t-test, 2 sided|||||||0.531
72372279|NCT04473235|144255003|SUPERIORITY||Mean Difference (Final Values)|0.02||||0.627|TWO_SIDED||||||t-test, 2 sided|||Difference in the connectivity between the left hippocampus and left prefrontal cortex.||||0.627
72372280|NCT04473235|144255003|SUPERIORITY||Mean Difference (Final Values)|0.08||||0.12|TWO_SIDED||||||t-test, 2 sided|||Difference in the connectivity between the right hippocampus and right prefrontal cortex.||||0.120
72372281|NCT01221285|144255039|SUPERIORITY_OR_OTHER||Fold change|1.8||||0.02|TWO_SIDED|95.0|1.1|2.8|||Fold change||Numerator is geometric mean post-baseline IgE. Denominator is baseline IgE.|||2.8|1.1|0.02
72372282|NCT01221285|144255040|SUPERIORITY_OR_OTHER||Fold change|2.5|||<|0.0001|TWO_SIDED|95.0|1.8|3.4|||Fold change||Numerator is geometric mean post-baseline IgG. Denominator is baseline IgG.|||3.4|1.8|<0.0001
72372283|NCT01221285|144255041|SUPERIORITY_OR_OTHER||Fold change|12.9|||<|0.0001|TWO_SIDED|95.0|7.5|22.5|||Fold Change||Numerator is geometric mean post-baseline IgG4. Denominator is baseline IgG4.|||22.5|7.5|<0.0001
72372284|NCT01221285|144255042|SUPERIORITY_OR_OTHER||Change|-42.8|||<|0.0001|TWO_SIDED|95.0|-59.4|-26.2|||Change||Numerator is geometric mean post-baseline FAB. Denominator is baseline FAB.|||-26.2|-59.4|<0.0001
72372285|NCT01904773|144255082|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.42|STANDARD_ERROR_OF_MEAN|0.9||0.0087||||||Bonferroni-Holm adjustment, compared with 0.025|ANCOVA|Each subject received each treatment multiple times in a crossover design||Comparison with placebo||||0.0087
72372286|NCT01904773|144255082|SUPERIORITY_OR_OTHER||Median Difference (Net)|1.34|STANDARD_ERROR_OF_MEAN|0.85||0.1198||||||Bonferroni-Holm compared with 0.025|ANCOVA|Each subject received each treatment multiple times in a crossover design||||||0.1198
72372287|NCT03861988|144255086|SUPERIORITY|||||||0.13|||||||Mixed Models Analysis|||||||0.13
72372288|NCT00220779|144255095|SUPERIORITY_OR_OTHER|||||||0.221||||||0.2g/kg IGIV Group versus Placebo|Cochran-Mantel-Haenszel|||The primary efficacy comparison was the comparison of the proportions of relapse free subjects (relapse defined as reported, not necessarily confirmed relapse). The multiple test procedure (hierarchical procedure) was to be stopped as soon as one of the statistical tests resulted in a non-significant P value \> 0.05.||||0.221
72372289|NCT00220779|144255095|SUPERIORITY_OR_OTHER|||||||0.471||||||0.4 g/kg IGIV Group versus Placebo|Cochran-Mantel-Haenszel|||The primary efficacy comparison was the comparison of the proportions of relapse free subjects (relapse defined as reported, not necessarily confirmed relapse). The multiple test procedure (hierarchical procedure) was to be stopped as soon as one of the statistical tests resulted in a non-significant P value \> 0.05.||||0.471
72372290|NCT02248675|144255098|SUPERIORITY_OR_OTHER|||||||0.153|||||||Regression, Linear|multiple regression controlling for baseline values of the dependent variable was used to examine between group effects at post-treatment||||||.153
72372291|NCT02248675|144255099|SUPERIORITY_OR_OTHER|||||||0.627|||||||Regression, Linear|||||||.627
72372292|NCT02248675|144255100|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Regression, Linear|multiple regression controlling for baseline values of the dependent variable was used to examine between group effects at post-treatment||||||<.001
72372293|NCT02248675|144255101|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Regression, Linear|multiple regression controlling for baseline values of the dependent variable was used to examine between group effects at post-treatment||||||<.001
72372294|NCT00281658|144255112|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.74||||0.0062|TWO_SIDED|95.0|0.58|0.94||Stratified Log-Rank (one-sided)|Log Rank||The treatment hazard ratio based on the proportional hazard model stratifying for metastatic disease sites and hormonal status. A hazard ratio \<1 indicates a lower risk with Lapatinib 1500mg + Paclitaxel compared with Placebo + Paclitaxel.|Primary OS analysis cut-off date = 18-Jun-2010||0.94|0.58|0.0062
72372295|NCT00281658|144255113|OTHER||Hazard Ratio (HR)|0.8|||||TWO_SIDED|95.0|0.64|0.98|||||The treatment hazard ratio based on the proportional hazard model stratifying for metastatic disease sites and hormonal status. A hazard ratio \<1 indicates a lower risk with Lapatinib 1500mg + Paclitaxel compared with Placebo + Paclitaxel.|Final OS analysis cut-0ff date = 23-Nov-2021||0.98|0.64|
72372296|NCT00281658|144255114|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.54|||||TWO_SIDED|95.0|0.44|0.66|||||The Pike estimator of the treatment hazard ratio based on the log rank test stratifying for metastatic disease sites and hormonal status. A hazard ratio \<1 indicates a lower risk with Lapatinib 1500mg + Paclitaxel compared with Placebo + Paclitaxel.|||0.66|0.44|
72372297|NCT00281658|144255115|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.3|||||TWO_SIDED|95.0|1.54|3.47||||||||3.47|1.54|
72372298|NCT00281658|144255116|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.34|||||TWO_SIDED|95.0|1.54|3.58||||||||3.58|1.54|
72372299|NCT00281658|144255121|OTHER||Odds Ratio (OR)|2.78|||||TWO_SIDED|95.0|1.07|7.57||||||Participants with PIK3CA wild-type||7.57|1.07|
72372300|NCT00281658|144255122|OTHER||Odds Ratio (OR)|2.42|||||TWO_SIDED|95.0|1.28|4.63||||||Participants with PTEN low||4.63|1.28|
72372301|NCT00281658|144255122|OTHER||Odds Ratio (OR)|2.21|||||TWO_SIDED|95.0|1.04|4.82||||||Participants without PTEN low||4.82|1.04|
72372302|NCT00281658|144255124|OTHER||Odds Ratio (OR)|3.15|||||TWO_SIDED|95.0|1.58|6.49||||||Participants with PTEN low||6.49|1.58|
72372303|NCT00281658|144255124|OTHER||Odds Ratio (OR)|2.49|||||TWO_SIDED|95.0|1.13|5.66||||||Participants without PTEN low||5.66|1.13|
72372304|NCT00813943|144255134|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.686||||0.0328|TWO_SIDED|95.0|0.484|0.972||P-value is not adjusted for multiple testing.|Log Rank|||||0.972|0.484|0.0328
72372305|NCT00813943|144255134|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.858||||0.3771|TWO_SIDED|95.0|0.612|1.204||P-value is not adjusted for multiple testing.|Log Rank|||||1.204|0.612|0.3771
72372306|NCT00265148|144255156|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.1334||||0.1695|TWO_SIDED|95.0|-0.0583|0.3251|||Mixed model for repeated measures|||For Grey matter||0.3251|-0.0583|0.1695
72372307|NCT00265148|144255156|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.175||||0.1057|TWO_SIDED|95.0|-0.038|0.388|||Mixed model for repeated measures|||For posterior cingulate Gyrus||0.3880|-0.0380|0.1057
72372308|NCT00265148|144255156|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.1426||||0.1833|TWO_SIDED|95.0|-0.0691|0.3543|||Mixed model for repeated measures|||For Frontal lobe||0.3543|-0.0691|0.1833
72372309|NCT00265148|144255156|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.1366||||0.1644|TWO_SIDED|95.0|-0.0574|0.3307|||Mixed model for repeated measures|||For parietal lobe||0.3307|-0.0574|0.1644
72372310|NCT00265148|144255156|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.1259||||0.1509|TWO_SIDED|95.0|-0.0471|0.2989|||Mixed model for repeated measures|||For Posterior temporal lobe||0.2989|-0.0471|0.1509
72372311|NCT00265148|144255156|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.1339||||0.2041|TWO_SIDED|95.0|-0.0747|0.3424|||Mixed model for repeated measures|||For cerebellum||0.3424|-0.0747|0.2041
72372312|NCT00265148|144255156|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.1094||||0.1445|TWO_SIDED|95.0|-0.0385|0.2572|||Mixed model for repeated measures|||For medial temporal lobe||0.2572|-0.0385|0.1445
72372313|NCT00265148|144255157|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.1211||||0.2251|TWO_SIDED|95.0|-0.0763|0.3185|||Mixed model for repeated measures|||At Month 1||0.3185|-0.0763|0.2251
72372314|NCT00265148|144255157|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.0893||||0.2497|TWO_SIDED|95.0|-0.0643|0.243|||Mixed model for repeated measures|||For Month 6||0.2430|-0.0643|0.2497
72372315|NCT00265148|144255158|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.11||||0.7618|TWO_SIDED|95.0|-0.59|0.8|||Repeated measure mixed model|||For BSR test , Month 1||0.80|-0.59|0.7618
72372316|NCT00265148|144255158|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.06||||0.835|TWO_SIDED|95.0|-0.53|0.66|||Repeated measure mixed model|||For BSR test, Month 6||0.66|-0.53|0.8350
72372317|NCT00265148|144255158|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.14||||0.6735|TWO_SIDED|95.0|-0.78|0.51|||Repeated measure mixed model|||For BSR test, Month 12||0.51|-0.78|0.6735
72372318|NCT00265148|144255159|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.07||||0.7045|TWO_SIDED|95.0|-0.44|0.3|||Repetaed measure mixed model|||For Month 1||0.30|-0.44|0.7045
72372319|NCT00265148|144255159|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.04||||0.8181|TWO_SIDED|95.0|-0.4|0.32|||Repeated measure mixed model|||For Month 6||0.32|-0.40|0.8181
72372320|NCT00265148|144255159|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.09||||0.7688|TWO_SIDED|95.0|-0.71|0.53|||Repeated measure mixed model|||AT Month 12||0.53|-0.71|0.7688
72372321|NCT00265148|144255159|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.07||||0.681|TWO_SIDED|95.0|-0.4|0.26|||Repeated measure mixed model|||Overall||0.26|-0.40|0.6810
72372322|NCT00265148|144255163|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.2||||0.8593|TWO_SIDED|95.0|-2.38|1.99|||Repeated measure mixed model|||At Month 1||1.99|-2.38|0.8593
72372323|NCT00265148|144255163|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|1.44||||0.3201|TWO_SIDED|95.0|-1.43|4.32|||Repeated measure mixed model|||At Month 6||4.32|-1.43|0.3201
72372324|NCT00265148|144255163|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|2.18||||0.2627|TWO_SIDED|95.0|-1.68|6.04|||Repeated measure mixed model|||At Month 12||6.04|-1.68|0.2627
72372325|NCT00265148|144255163|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|1.14||||0.3633|TWO_SIDED|95.0|-1.35|3.64|||Repeated measure mixed model|||For overall period||3.64|-1.35|0.3633
72372326|NCT00265148|144255164|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.11||||0.5647|TWO_SIDED|95.0|-0.48|0.26|||Repetaed measure mixed model|||For overall period||0.26|-0.48|0.5647
72372327|NCT00265148|144255164|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.0||||0.9935|TWO_SIDED|95.0|-0.46|0.46|||Repeated measure mixed model|||For Month 1||0.46|-0.46|0.9935
72372328|NCT00265148|144255164|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.22||||0.3794|TWO_SIDED|95.0|-0.72|0.28|||Repeated measure mixed model|||At Month 6||0.28|-0.72|0.3794
72372329|NCT00265148|144255164|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.1||||0.7357|TWO_SIDED|95.0|-0.7|0.49|||Repeated measure mixed model|||At Month 12||0.49|-0.70|0.7357
72372330|NCT00265148|144255167|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-4971.6||||0.6299|TWO_SIDED|95.0|-255515.6|15572.4|||Repeated measure mixed model|Arithmetic means have been presented; however, statistical analysis is based upon the least square (LS) means||At Month 6||15572.4|-255515.6|0.6299
72372331|NCT00265148|144255167|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|12223.0||||0.2184|TWO_SIDED|95.0|-7450.6|31896.5|||Repeated measure mixed model|||At Month 12||31896.5|-7450.6|0.2184
72372332|NCT00265148|144255168|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.6||||0.0129|TWO_SIDED|95.0|-1.0|-0.1|||Repeated measure mixed model|||For Month 6||-0.1|-1.0|0.0129
72372333|NCT00265148|144255168|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.2||||0.5607|TWO_SIDED|95.0|-1.0|0.6|||Repeated measure mixed model|||For Month 12||0.6|-1.0|0.5607
72372334|NCT00265148|144255180|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.1154||||0.28|TWO_SIDED|95.0|-0.0967|0.3275|||Repeated measure mixed model|||For Grey matter, APOE Epsilon-4 status positive||0.3275|-0.0967|0.2800
72372335|NCT00265148|144255180|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.1337||||0.4159||95.0|-0.1931|0.4605|||Repeated measure mixed model|||For Grey matter, APOE Epsilon-4 status negative||0.4605|-0.1931|0.4159
72372336|NCT00265148|144255180|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.1491||||0.2158|TWO_SIDED|95.0|-0.0897|0.3878|||Repeated measure mixed model|||For posterior cingulate gyrus, APOE Epsilon-4 status positive||0.3878|-0.0897|0.2158
72372337|NCT00265148|144255180|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.2346||||0.2087|TWO_SIDED|95.0|-0.135|0.6042|||Repeated measure mixed model|||For posterior cingulate gyrus, APOE Epsilon-4 status negative||0.6042|-0.1350|0.2087
72372338|NCT00265148|144255180|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.1233||||0.3064|TWO_SIDED|95.0|-0.1162|0.3628|||Repeated measure mixed model|||For Frontal lobe, APOE Epsilon-4 status positive||0.3628|-0.1162|0.3064
72372339|NCT00265148|144255180|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.1734||||0.35|TWO_SIDED|95.0|-0.1952|0.542|||Repeated measure mixed model|||For Frontal lobe APOE Epsilon-4 status negative||0.5420|-0.1952|0.3500
72372340|NCT00265148|144255180|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.13||||0.2487|TWO_SIDED|95.0|-0.0937|0.3538|||Repeated measure mixed model|||For parietal lobe, APOE Epsilon-4 status positive||0.3538|-0.0937|0.2487
72372341|NCT00265148|144255180|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.1038||||0.5521|TWO_SIDED|95.0|-0.244|0.4516|||Repeated measure mixed model|||For parietal lobe, APOE Epsilon-4 status negative||0.4516|-0.2440|0.5521
72372342|NCT00265148|144255180|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.1384||||0.176|TWO_SIDED|95.0|-0.064|0.3409|||Repeated measure mixed model|||For posterior temporal lobe, APOE Epsilon-4 status positive||0.3409|-0.0640|0.1760
72372343|NCT00265148|144255180|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.0837||||0.5952|TWO_SIDED|95.0|-0.2303|0.3978|||Repeated measure mixed model|||For posterior temporal lobe, APOE Epsilon-4 status negative||0.3978|-0.2303|0.5952
72372344|NCT00265148|144255180|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.0847||||0.4025|TWO_SIDED|95.0|-0.1169|0.2863|||Repeated measure mixed model|||For Cerebellum, APOE Epsilon-4 status positive||0.2863|-0.1169|0.4025
72372345|NCT00265148|144255180|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.1536||||0.3081|TWO_SIDED|95.0|-0.1458|0.453|||Repeated measure mixed model95|||For Cerebellum, APOE Epsilon-4 status negative||0.4530|-0.1458|0.3081
72372346|NCT00265148|144255180|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.0839||||0.2964|TWO_SIDED|95.0|-0.0758|0.2436|||Repeated measure mixed model|||For medial temporal lobe, APOE Epsilon-4 status positive||0.2436|-0.0758|0.2964
72372347|NCT00265148|144255180|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.1536||||0.2101|TWO_SIDED|95.0|-0.0892|0.3963|||Repeated measure mixed model|||For medial temporal lobe, APOE Epsilon-4 status negative||0.3963|-0.0892|0.2101
72372348|NCT00606905|144255189|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.37|||<|0.05|TWO_SIDED|95.0|0.41|4.61|||Chi-squared|||||4.61|0.41|<0.05
72372349|NCT01147627|144255207|NON_INFERIORITY_OR_EQUIVALENCE|108 patients in each group was needed to provide 90% power to detect non-inferiority of exenatide, shown by a mean difference of 0.4% in HbA1c change from baseline.|||||<|0.05||95.0|||||ANCOVA|||||||<0.05
72372350|NCT02223377|144255215|SUPERIORITY||Odds Ratio (OR)|1.0||||0.997|TWO_SIDED|95.0|0.56|1.78|||Regression, Logistic|||||1.78|0.56|0.997
72372351|NCT02223377|144255220|SUPERIORITY||Mean Difference (Final Values)|-0.73||||0.04|TWO_SIDED|95.0|-1.43|-0.03|||ANOVA|||||-0.03|-1.43|0.040
72372352|NCT01767142|144255255|OTHER||sucess proportion|83.9|||||TWO_SIDED|95.0|74.8|90.7||||||||90.7|74.8|
72372353|NCT01024309|144255276|SUPERIORITY_OR_OTHER|||||||0.04||||||Apriori level of significance was 0.05|Wilcoxon (Mann-Whitney)|Wilcoxon Rank Sum was used||||||.04
72372354|NCT01024309|144255277|SUPERIORITY_OR_OTHER|||||||0.08||||||the a priori threshold for statistical significance was 0.05|Wilcoxon (Mann-Whitney)|Wilcoxon Rank Sum Test||||||0.08
72372355|NCT01024309|144255278|SUPERIORITY_OR_OTHER|||||||0.04||||||the a priori threshold for statistical significance was 0.05|Wilcoxon (Mann-Whitney)|Wilcoxon Rank Sum Test was used||||||0.04
72372356|NCT01024309|144255279|SUPERIORITY_OR_OTHER|||||||0.22||||||the a priori threshold for statistical significance was 0.05|Wilcoxon (Mann-Whitney)|Wilcoxon Rank Sum Test was used||||||0.22
72372357|NCT01024309|144255280|SUPERIORITY_OR_OTHER|||||||0.0029||||||the a priori threshold for statistical significance was 0.05|Wilcoxon (Mann-Whitney)|Wilcoxon Rank Sum Test was used||||||.0029
72372358|NCT01024309|144255281|SUPERIORITY_OR_OTHER|||||||0.13||||||the a priori threshold for statistical significance was 0.05|Wilcoxon (Mann-Whitney)|Wilcoxon Rank Sum Test was used||||||0.13
72372359|NCT01024309|144255282|SUPERIORITY_OR_OTHER|||||||0.29||||||a priori threshold for statistical significance was 0.05|Wilcoxon (Mann-Whitney)|Wilcoxon Rank Sum||||||0.29
72372360|NCT01024309|144255283|SUPERIORITY_OR_OTHER|||||||0.23||||||the a priori threshold for statistical significance was 0.05|Wilcoxon (Mann-Whitney)|Wilcoxon Rank Sum Test was used||||||0.23
72372361|NCT01024309|144255284|SUPERIORITY_OR_OTHER|||||||0.49||||||the a priori threshold for statistical significance was 0.05|Wilcoxon (Mann-Whitney)|Wilcox Rank Sum Test||||||0.49
72372362|NCT02737891|144255285|SUPERIORITY||Mean Difference (Net)|-3.8||||0.004|TWO_SIDED|95.0|-6.36|-1.29||Two-sided p-value for test of no difference from 0.|ANCOVA|||The analysis was based on a parametric model, i.e. compared between treatment arms by means of an analysis of covariance (ANCOVA) model (proc MIXED) using change from baseline to the end of treatment as dependent variable, treatment and study site as fixed effects and the value from baseline as covariate. The residual errors were assumed independent and identically distributed (i.i.d.) and normally distributed.||-1.29|-6.36|0.004
72372363|NCT02737891|144255286|SUPERIORITY||Mean Difference (Net)|0.1||||0.724|TWO_SIDED|95.0|-0.23|0.33||Two-sided p-value for test of no difference from 0.|ANCOVA|||The analysis was based on a parametric model, i.e. compared between treatment arms by means of an analysis of covariance (ANCOVA) model (proc MIXED) using change from baseline to the end of treatment as dependent variable, treatment and study site as fixed effects and the value from baseline as covariate. The residual errors were assumed independent and identically distributed (i.i.d.) and normally distributed.||0.33|-0.23|0.724
72372364|NCT02737891|144255287|SUPERIORITY||Mean Difference (Net)|-3.5|||<|0.0001|TWO_SIDED|95.0|-4.65|-2.3||Two-sided p-value for test of no difference from 0.|ANCOVA|||The analysis was based on a parametric model, i.e. compared between treatment arms by means of an analysis of covariance (ANCOVA) model (proc MIXED) using change from baseline to the end of treatment as dependent variable, treatment and study site as fixed effects and the value from baseline as covariate. The residual errors were assumed independent and identically distributed (i.i.d.) and normally distributed.||-2.30|-4.65|<0.0001
72372365|NCT05194579|144255288|EQUIVALENCE|Pharmacokinetic equivalence were assessed by constructing the 90% confidence intervals (CIs) for the GMR (test/reference) for Cmax, AUClast and AUCinf. This table displays Cmax statistical analysis.|Ratio of Geometric Mean|117.06|||||TWO_SIDED|90.0|103.07|132.93|||ANOVA|||The null hypothesis was PF-06881894 OBI was not equivalent to PF-06881894 PFS.||132.93|103.07|
72372366|NCT05194579|144255289|EQUIVALENCE|Pharmacokinetic equivalence were assessed by constructing the 90% CIs for the GMR (test/reference) for Cmax, AUClast and AUCinf. This table displays AUClast statistical analysis.|Ratio of Geometric Mean|122.12|||||TWO_SIDED|90.0|107.9|138.22|||ANOVA|||The null hypothesis was PF-06881894 OBI was not equivalent to PF-06881894 PFS.||138.22|107.90|
72493594|NCT00511355|144516385|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0024||95.0||||No correction for multiple testing was made.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for age class applied on the changes from baseline.||P-value compares the change from baseline to Cycle 6 between treatment groups.||||0.0024
72372367|NCT05194579|144255290|EQUIVALENCE|Pharmacokinetic equivalence were assessed by constructing the 90% CIs for the GMR (test/reference) for Cmax, AUClast and AUCinf. This table displays AUCinf statistical analysis.|Ratio of Geometric Mean|123.75|||||TWO_SIDED|90.0|108.75|140.82|||ANOVA|||The null hypothesis was PF-06881894 OBI was not equivalent to PF-06881894 PFS.||140.82|108.75|
72372368|NCT03890666|144255294|OTHER||Odds Ratio (OR)|1.33||||||||||||||The statistical model is a logistic regression model with treatment group as a fixed factor, pooled study sites as a random factor, and baseline ACT score as a covariate.||||
72372369|NCT00567255|144255315|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.56|||<|0.001||95.0|-5.19|-3.93|||ANCOVA|||||-3.93|-5.19|<0.001
72372370|NCT00567255|144255316|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.16|||<|0.001|TWO_SIDED|95.0|-5.95|-4.38|||ANCOVA|||||-4.38|-5.95|<0.001
72372371|NCT00567255|144255317|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.61|||<|0.001||95.0|4.95|8.84|||Regression, Logistic|||||8.84|4.95|<0.001
72372372|NCT00567255|144255318|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.5|||<|0.001|TWO_SIDED|95.0|4.05|7.47|||Regression, Logistic|||||7.47|4.05|<0.001
72372373|NCT00567255|144255319|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.36|||<|0.001|TWO_SIDED|95.0|3.6|7.98|||Regression, Logistic|||||7.98|3.60|<0.001
72372374|NCT00567255|144255320|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.43|||<|0.001|TWO_SIDED|95.0|-4.33|-2.53|||ANCOVA|||||-2.53|-4.33|<0.001
72372375|NCT00567255|144255321|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.59|||<|0.001|TWO_SIDED|95.0|1.61|3.57|||ANCOVA|||||3.57|1.61|<0.001
72372376|NCT00567255|144255322|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.96||||0.007|TWO_SIDED||||||ANCOVA|||||||0.007
72372377|NCT00567255|144255323|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.77|||<|0.001|TWO_SIDED|95.0|2.46|5.09|||ANCOVA|||||5.09|2.46|<0.001
72372378|NCT00567255|144255324|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-8.24||||0.091|TWO_SIDED||||||ANCOVA|||||||0.091
72372379|NCT00567255|144255325|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-13.64|||||TWO_SIDED|||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||
72372380|NCT00567255|144255326|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.38|||||TWO_SIDED|95.0|-1.6|0.85||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||0.85|-1.60|
72372381|NCT00567255|144255327|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-12.29|||||TWO_SIDED|||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||
72372382|NCT00567255|144255328|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-7.23|||||TWO_SIDED|95.0|-9.92|-4.54||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||-4.54|-9.92|
72372383|NCT00567255|144255329|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.36|||||TWO_SIDED|95.0|-7.29|-1.44||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||-1.44|-7.29|
72372384|NCT00567255|144255330|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.3|||||TWO_SIDED|95.0|-0.7|1.3||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||1.30|-0.70|
72372385|NCT00567255|144255331|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.87|||||TWO_SIDED|95.0|0.16|1.58||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||1.58|0.16|
72372386|NCT00567255|144255332|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.06|||||TWO_SIDED|95.0|-0.49|0.6||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||0.60|-0.49|
72372387|NCT00567255|144255333|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.02|||||TWO_SIDED|95.0|-0.56|0.52||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||0.52|-0.56|
72372388|NCT00567255|144255334|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.48|||||TWO_SIDED|95.0|-0.98|0.02||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||0.02|-0.98|
72372389|NCT03052426|144255335|SUPERIORITY|||||||0.9327||||||p=0.05 is the threshold for statistical significance|Chi-squared|ChiSqaure 0.1394, DF 2 for aches||Wilcoxon/Kruskal-Wallis Tests and ChiSqaure analysis were completed for aches/pains at the three month time frame||||0.9327
72372390|NCT03052426|144255335|SUPERIORITY|||||||0.7523||||||p=0.05 is the threshold for statistical significance|Chi-squared|ChiSquare 0.5693, DF 2||Wilcoxon/Kruskal-Wallis Tests and ChiSqaure analysis were completed for discomfort at the three month time frame||||0.7523
72372391|NCT03052426|144255335|SUPERIORITY|||||||0.9196||||||p=0.05 is the threshold for statistical significance|Chi-squared|ChiSquare 0.1676, DF 2||Wilcoxon/Kruskal-Wallis Tests and ChiSqaure analysis were completed for interference at the three month time frame.||||0.9196
72372392|NCT03052426|144255336|SUPERIORITY|||||||0.6316||||||p=0.05 is the threshold for statistical significance|Chi-squared|ChiSqaure 0.9190, DF 2||Wilcoxon/Kruskal-Wallis Tests and ChiSquare Analysis were completed||||0.6316
72372393|NCT03052426|144255336|SUPERIORITY|||||||0.2595||||||p=0.05 is the threshold for statistical significance|Chi-squared|ChiSqaure 2.6983, DF||Wilcoxon/Kruskal-Wallis Tests and ChiSqaure analysis were completed for discomfort at the six month time frame.||||0.2595
72372394|NCT03052426|144255336|SUPERIORITY|||||||0.4495||||||p=0.05 is the threshold for statistical significance|Chi-squared|ChiSquare 1.5991, DF 2||Wilcoxon/Kruskal-Wallis Tests and ChiSqaure analysis were completed for interference at the six month time frame||||0.4495
72372395|NCT03052426|144255337|SUPERIORITY||||||<|0.0001||||||Aches (F-test G-G Epsilon (1.26, 15.18) = 34.70, p \< 0.0001)|MANOVA|||Three and six month results were combined and compared to baseline data for each of the outcome variables. Repeated measures MANOVAs with pairwise comparisons were used to examine the decrease of variables over time from time 1 to times 2 and 3.||||<0.0001
72372396|NCT03052426|144255337|SUPERIORITY||||||=|0.0006||||||Uncomfortable (F-test G-G Epsilon (1.43, 17.15) = 14.39, p = 0.0006), from time 1 to times 2 and 3|MANOVA|||Three and six month results were combined and compared to baseline data for each of the outcome variables. Repeated measures MANOVAs with pairwise comparisons were used to examine the decrease of variables over time from time 1 to times 2 and 3.||||=0.0006
72372397|NCT03052426|144255337|SUPERIORITY||||||<|0.0001||||||Interference (F-test G-G Epsilon (1.55, 18.66) = 34.09, p \< 0.0001), from time 1 to times 2 and 3.|MANOVA|||We used repeated measures MANOVAs with pairwise comparisons to examine the decrease of the variables over time. Significant differences for within subjects by time were found||||<0.0001
72372398|NCT03083990|144255341|EQUIVALENCE|Geometric mean ratio and its 90%CI are obtained after anti-logarithmic transformation.If 90% CI for the geometric mean ratio of AUC 0-t and AUC 0-∞ (trial/control) ranges between 0.8-1.25, then it is considered that IBI305 and Bevacizumab are bioequivalent.|Odds Ratio (OR)|0.9502|||>|0.05|TWO_SIDED|90.0|0.8921|1.012|||ANOVA|||||1.0120|0.8921|>0.05
72372399|NCT03083990|144255342|EQUIVALENCE|Geometric mean ratio and its 90%CI are obtained after anti-logarithmic transformation.If 90% CI for the geometric mean ratio of AUC 0-t and AUC 0-∞ (trial/control) ranges between 0.8-1.25, then it is considered that IBI305 and Bevacizumab are bioequivalent.|Odds Ratio (OR)|0.9483|||>|0.05|TWO_SIDED|90.0|0.8896|1.0108|||ANOVA|||||1.0108|0.8896|>0.05
72372400|NCT03083990|144255343|EQUIVALENCE||Odds Ratio (OR)|0.9749|||>|0.05|TWO_SIDED|90.0|0.9123|1.0418|||ANOVA|||||1.0418|0.9123|>0.05
72372401|NCT04145219|144255353|SUPERIORITY||Mean Difference (Final Values)|1.0|||<|0.0001|TWO_SIDED|95.0|0.5|1.4||This endpoint was controlled for multiplicity using hierarchical testing|Mixed Models Analysis||Placebo vs. 12 SQ-HDM|The average daily TCRS was analysed using a linear mixed effect (LME) model with square root transformation. The model includes the square root of the endpoint as response variable, treatment and cohort as fixed factors, the square root of the baseline value as a covariate, country/region within cohort as a random effect, and with different residual errors specified for each treatment. No missing data approach was applied.||1.4|0.5|<0.0001
72372402|NCT04145219|144255354|SUPERIORITY||Mean Difference (Final Values)|0.4|||<|0.0001|TWO_SIDED|95.0|0.2|0.6||This endpoint was controlled for multiplicity using hierarchical testing|Mixed Models Analysis||Placebo vs. 12 SQ-HDM|The average rhinitis DSS was analysed using a linear mixed effect (LME) model with square root transformation. The model includes the square root of the endpoint as response variable, treatment and cohort as fixed factors, the square root of the baseline value as a covariate, country/region within cohort as a random effect, and with different residual errors specified for each treatment. No missing data approach was applied.||0.6|0.2|<0.0001
72372403|NCT04145219|144255355|SUPERIORITY||Mean Difference (Final Values)|0.5||||0.0016|TWO_SIDED|95.0|0.2|0.8||This endpoint was controlled for multiplicity using hierarchical testing|Mixed Models Analysis|||The average rhinitis DMS was analysed using a linear mixed effect (LME) model with square root transformation. The model includes the square root of the endpoint as response variable, treatment and cohort as fixed factors, the square root of the baseline value as a covariate, country/region within cohort as a random effect, and with different residual errors specified for each treatment. No missing data approach was applied.||0.8|0.2|0.0016
72372404|NCT04145219|144255356|SUPERIORITY||Mean Difference (Final Values)|1.1|||<|0.0001|TWO_SIDED|95.0|0.6|1.7||This endpoint was controlled for multiplicity using hierarchical testing|Mixed Models Analysis||Placebo vs.12 SQ-HDM|||1.7|0.6|<0.0001
72372405|NCT04145219|144255357|SUPERIORITY||Mean Difference (Final Values)|0.5|||<|0.0001|TWO_SIDED|95.0|0.3|0.7|||Mixed Models Analysis||Placebo vs. 12 SQ-HDM|The average rhinoconjunctivitis DSS was analysed using a linear mixed effect (LME) model with square root transformation. The model includes the square root of the endpoint as response variable, treatment and cohort as fixed factors, the square root of the baseline value as a covariate, country/region within cohort as a random effect, and with different residual errors specified for each treatment. No missing data approach was applied.||0.7|0.3|<0.0001
72372406|NCT04145219|144255358|SUPERIORITY||Mean Difference (Final Values)|0.6||||0.0018|TWO_SIDED|95.0|0.2|1.0|||Mixed Models Analysis||Placebo vs. 12 SQ-HDM|The average rhinoconjunctivitis DMS was analysed using a linear mixed effect (LME) model with square root transformation. The model includes the square root of the endpoint as response variable, treatment and cohort as fixed factors, the square root of the baseline value as a covariate, country/region within cohort as a random effect, and with different residual errors specified for each treatment. No missing data approach was applied.||1.0|0.2|0.0018
72372407|NCT04145219|144255359|SUPERIORITY||Mean Difference (Final Values)|0.2|||<|0.0001|TWO_SIDED|95.0|0.1|0.2||This endpoint was controlled for multiplicity using hierarchical testing|Mixed Models Analysis||Placebo vs. 12 SQ-HDM|The overall PRQLQ score was analysed using a linear mixed effect (LME) model. The model includes the overall PRQLQ score as response variable, treatment and cohort as fixed factors, the baseline overall PRQLQ score as a covariate, country/region within cohort as a random effect, and with different residual errors specified for each treatment. No missing data approach was applied.||0.2|0.1|<0.0001
72372408|NCT04145219|144255360|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.0259|TWO_SIDED|95.0|0.0|0.2|||Mixed Models Analysis||Placebo vs. 12 SQ-HDM|The average asthma DSS was analysed using a linear mixed effect (LME) model with square root transformation. The model includes the square root of the endpoint as response variable, treatment and cohort as fixed factors, the square root of the baseline value as a covariate, country/region within cohort as a random effect, and with different residual errors specified for each treatment. No missing data approach was applied.||0.2|0.0|0.0259
72372409|NCT04145219|144255361|SUPERIORITY||Odds Ratio (OR)|1.8||||0.0527|TWO_SIDED|95.0|1.0|3.3|||Generalised linear mixed model (GLMM)||Odds ratio is (odds 12 SQ-HDM / odds Placebo)|The odds of having a SABA free day was analysed using a generalised linear mixed model (GLMM) with a logit link function. The model included SABA free day (yes/no) as response variable, treatment and cohort as fixed effects, the baseline average asthma DSS as a covariate, the combined (country/region) variable within cohort and subject as random effects. Proportion is the estimated probability of having a day where a subject with asthma did not use SABA, odds ratio is (odds active/odds Placebo).||3.3|1.0|0.0527
72372410|NCT04145219|144255362|SUPERIORITY||Mean Difference (Final Values)|0.4||||0.1256|TWO_SIDED|95.0|-0.1|1.0|||Mixed Models Analysis||Placebo vs. 12 SQ-HDM|The endpoint was analysed using a linear mixed effect (LME) model. The model includes the endpoint as response variable, treatment and cohort as fixed factors, the baseline value as a covariate, country/region within cohort as a random effect, and with different residual errors specified for each treatment. No missing data approach was applied.||1.0|-0.1|0.1256
72372411|NCT04145219|144255363|SUPERIORITY||Odds Ratio (OR)|1.8||||0.0008|TWO_SIDED|95.0|1.3|2.5|||Generalised linear mixed model (GLMM)||Odds ratio is (odds 12 SQ-HDM / odds Placebo)|The odds of having a rhinitis mild day was analysed using a generalised linear mixed model (GLMM) with a logit link function. The model included the endpoint (yes/no) as response variable, treatment and cohort as fixed effects, the baseline average rhinitis TCRS as a covariate, the combined (country/region) variable within cohort and subject as random effects. Proportion is the estimated probability of having a day with no or mild rhinitis symptoms, odds ratio is (odds 12 SQ-HDM / odds Placebo).||2.5|1.3|0.0008
72372412|NCT04145219|144255364|SUPERIORITY||Odds Ratio (OR)|0.6|||<|0.0001|TWO_SIDED|95.0|0.4|0.7|||Generalised linear mixed model (GLMM)||Odds ratio is (odds 12 SQ-HDM / odds Placebo)|The odds of having a rhinitis exacerbation day was analysed using a generalised linear mixed model (GLMM) with a logit link function. The model included the endpoint (yes/no) as response variable, treatment and cohort as fixed effects, the baseline average rhinitis DSS as a covariate, the combined (country/region) variable within cohort and subject as random effects. Proportion is the estimated probability of having a rhinitis exacerbation day, odds ratio is (odds 12 SQ-HDM / odds Placebo).||0.7|0.4|<0.0001
72493595|NCT00511355|144516386|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3653||95.0||||No correction for multiple testing was made.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for age class applied on the changes from baseline.||P-value compares the change from baseline to Cycle 6 between treatment groups.||||0.3653
72372413|NCT04145219|144255365|SUPERIORITY||Mean Difference (Final Values)|0.2|||<|0.0001|TWO_SIDED|95.0|0.1|0.3|||Mixed Models Analysis||Placebo vs. 12 SQ-HDM|The average rhinitis CSMS was analysed using a linear mixed effect (LME) model with square root transformation. The model includes the square root of the endpoint as response variable, treatment and cohort as fixed factors, the square root of the baseline value as a covariate, country/region within cohort as a random effect, and with different residual errors specified for each treatment. No missing data approach was applied.||0.3|0.1|<0.0001
72372414|NCT04145219|144255366|SUPERIORITY||Mean Difference (Final Values)|0.2|||<|0.0001|TWO_SIDED|95.0|0.1|0.3|||Mixed Models Analysis||Placebo vs. 12 SQ-HDM|The average rhinoconjunctivitis CSMS was analysed using a linear mixed effect (LME) model with square root transformation. The model includes the square root of the endpoint as response variable, treatment and cohort as fixed factors, the square root of the baseline value as a covariate, country/region within cohort as a random effect, and with different residual errors specified for each treatment. No missing data approach was applied.||0.3|0.1|<0.0001
72372415|NCT04975438|144255388|OTHER||Posterior Median Difference|-33.21|||||TWO_SIDED|95.0|-50.96|-14.84|||||The posterior median of the difference (GSK1070806 - placebo) and 95% credible interval in PCFB in the EASI is presented. Analysis was performed using Bayesian analysis under the hypothetical strategy using an informative prior (robust MAP prior).|||-14.84|-50.96|
72372416|NCT04975438|144255389|OTHER||Posterior Median Difference|-9.68|||||TWO_SIDED|95.0|-15.7|-3.6|||||The posterior median of the difference (GSK1070806 - placebo) and 95% credible interval in PCFB in the EASI is presented. Analysis was performed using Bayesian analysis with vague priors and adjusting for baseline EASI.|||-3.60|-15.70|
72372417|NCT01168986|144255405|SUPERIORITY_OR_OTHER|||||||0.1|||||||Mixed Models Analysis|||||||0.10
72372418|NCT01168986|144255406|SUPERIORITY_OR_OTHER|||||||0.18|TWO_SIDED||||||Mixed Models Analysis|||||||0.18
72372419|NCT01168986|144255407|SUPERIORITY_OR_OTHER|||||||0.87|TWO_SIDED||||||Mixed Models Analysis|||||||0.87
72372420|NCT01168986|144255408|SUPERIORITY_OR_OTHER|||||||0.45|TWO_SIDED||||||Mixed Models Analysis|||||||0.45
72372421|NCT00275340|144255454|NON_INFERIORITY_OR_EQUIVALENCE|Study was not powered to determine significant group differences; thus trends are reported for p\<0.20.|||||p<|0||95.0|||||t-test, 2 sided|||Mean change scores were computed on domain and summary scores. Mean differences in change scores between groups were computed and t-tests used to detect significant differences.||||p<0.20
72372422|NCT01798849|144255464|OTHER||Difference in Least-square (LS) Means|-0.5||||0.732|TWO_SIDED|95.0|-3.42|2.43|||Mixed effect model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo|||2.43|-3.42|0.732
72372423|NCT01798849|144255464|OTHER||Difference in LS means|-0.94||||0.531|TWO_SIDED|95.0|-3.94|2.06|||Mixed effects model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant|Difference in LS means = LS mean MK-8892 minus LS mean placebo|||2.06|-3.94|0.531
72372424|NCT01798849|144255464|OTHER||Difference in LS Means|-2.88||||0.056|TWO_SIDED|95.0|-5.83|0.08|||Mixed effects model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo|||0.08|-5.83|0.056
72372425|NCT01798849|144255464|OTHER||Difference in LS means|-2.92||||0.063|TWO_SIDED|95.0|-6.0|0.17|||Mixed effects model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo|||0.17|-6.00|0.063
72372426|NCT01798849|144255464|OTHER||Difference in LS means|-4.89||||0.002|TWO_SIDED|95.0|-7.79|-1.99|||Mixed effects model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo|||-1.99|-7.79|0.002
72372427|NCT01798849|144255464|OTHER||Difference in LS means|-5.31||||0.001|TWO_SIDED|95.0|-8.32|-2.31|||Mixed effects model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo|||-2.31|-8.32|0.001
72372428|NCT01798849|144255464|OTHER||Difference in LS means|-5.61||||0.001|TWO_SIDED|95.0|-8.62|-2.6|||Mixed effects model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo|||-2.60|-8.62|0.001
72493596|NCT00511355|144516387|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0||||No correction for multiple testing was made.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for age class applied on the changes from baseline.||P-value compares the change from baseline to Cycle 6 between treatment groups.||||<.0001
72372429|NCT01798849|144255464|OTHER||Difference in LS means|-7.56|||<|0.0001|TWO_SIDED|95.0|-10.5|-4.63|||Mixed effects model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo|||-4.63|-10.50|<0.0001
72372430|NCT01798849|144255467|OTHER||Difference in LS means|-2.34||||0.165|TWO_SIDED|95.0|-5.7|1.02|||Mixed effects model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo|||1.02|-5.70|0.165
72372431|NCT01798849|144255467|OTHER||Difference in LS means|-3.53||||0.038|TWO_SIDED|95.0|-6.86|-0.21|||Mixed effects model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo|||-0.21|-6.86|0.038
72372432|NCT01798849|144255467|OTHER||Difference in LS means|-6.32||||0|TWO_SIDED|95.0|-9.55|-3.1|||Mixed effects model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo|||-3.10|-9.55|0.000
72372433|NCT01798849|144255467|OTHER||Difference in LS means|-6.63|||<|0.0001|TWO_SIDED|95.0|-9.35|-3.92|||Mixed effects model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo|||-3.92|-9.35|<0.0001
72372434|NCT01798849|144255468|OTHER||Difference in LS means|-2.67||||0.128|TWO_SIDED|95.0|-6.14|0.8|||Mixed effect model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo|||0.80|-6.14|0.128
72372435|NCT01798849|144255468|OTHER||Difference in LS means|-0.76||||0.305|TWO_SIDED|95.0|-2.24|0.72|||Mixed effect model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo|||0.72|-2.24|0.305
72372436|NCT01798849|144255468|OTHER||Difference in LS means|-2.03||||0.07|TWO_SIDED|95.0|-4.23|0.17|||Mixed effects model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo|||0.17|-4.23|0.070
72372437|NCT01798849|144255468|OTHER||Difference in LS means|-2.84||||0.036|TWO_SIDED|95.0|-5.48|-0.19|||Mixed effects model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo|||-0.19|-5.48|0.036
72372438|NCT01798849|144255468|OTHER||Difference in LS means|-4.89|||<|0.0001|TWO_SIDED|95.0|-6.4|-3.37|||Mixed effects model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo|||-3.37|-6.40|<0.0001
72372439|NCT01798849|144255468|OTHER||Difference in LS means|-5.37|||<|0.0001|TWO_SIDED|95.0|-7.29|-3.46|||Mixed effects model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo|||-3.46|-7.29|<0.0001
72372440|NCT01798849|144255468|OTHER||Difference in LS means|-5.68|||<|0.0001|TWO_SIDED|95.0|-6.7|-4.65|||Mixed effect model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo|||-4.65|-6.70|<0.0001
72372441|NCT01798849|144255468|OTHER||Difference in LS means|-8.22|||<|0.0001|TWO_SIDED|95.0|-11.95|-4.5|||Mixed effect model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo|||-4.50|-11.95|<0.0001
72372442|NCT01798849|144255469|OTHER||Difference in LS means|-1.77||||0.212|TWO_SIDED|95.0|-4.59|1.05|||Mixed effect model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo|||1.05|-4.59|0.212
72372443|NCT01798849|144255469|OTHER||Difference in LS means|3.32||||0.05|TWO_SIDED|95.0|0.0|6.64|||Mixed effect model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo|||6.64|0.00|0.050
72372444|NCT01798849|144255469|OTHER||Difference in LS means|2.48||||0.016|TWO_SIDED|95.0|0.49|4.47|||Mixed effect model||Difference in LS means = LS mean MK-8892 minus LS mean placebo|||4.47|0.49|0.016
72372445|NCT01798849|144255469|OTHER||Difference in LS means|5.21||||0.007|TWO_SIDED|95.0|1.51|8.92|||Mixed effect model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo|||8.92|1.51|0.007
72372446|NCT01798849|144255469|OTHER||Difference in LS means|7.06||||0.001|TWO_SIDED|95.0|3.03|11.1|||Mixed effect model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo|||11.10|3.03|0.001
72372447|NCT01798849|144255469|OTHER||Difference in LS means|6.62||||0.002|TWO_SIDED|95.0|2.54|10.71|||Mixed effect model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo|||10.71|2.54|0.002
72372448|NCT01798849|144255469|OTHER||Difference in LS means|8.11|||<|0.0001|TWO_SIDED|95.0|5.45|10.76|||Mixed effect model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo|||10.76|5.45|<0.0001
72372449|NCT01798849|144255469|OTHER||Difference in LS means|14.05|||<|0.0001|TWO_SIDED|95.0|10.54|17.57|||Mixed effect model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo|||17.57|10.54|<0.0001
72372450|NCT01798849|144255470|OTHER||Difference in LS means|-1.66||||0.202|TWO_SIDED|95.0|-4.24|0.93|||Mixed effect model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo|||0.93|-4.24|0.202
72372451|NCT01798849|144255470|OTHER||Difference in LS means|-2.23||||0.115|TWO_SIDED|95.0|-5.03|0.57|||Mixed effect model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo|||0.57|-5.03|0.115
72372452|NCT01798849|144255470|OTHER||Difference in LS means|-2.75||||0.043|TWO_SIDED|95.0|-5.4|-0.09|||Mixed effect model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo|||-0.09|-5.40|0.043
72372453|NCT01798849|144255470|OTHER||Difference in LS means|-0.19||||0.901|TWO_SIDED|95.0|-3.22|2.84|||Mixed effect model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo|||2.84|-3.22|0.901
72372454|NCT01798849|144255470|OTHER||Mixed effect model|-4.15||||0.002|TWO_SIDED|95.0|-6.74|-1.57|||Mixed effect model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|||-1.57|-6.74|0.002
72372455|NCT01798849|144255470|OTHER||Difference in LS means|-3.77||||0.008|TWO_SIDED|95.0|-6.48|-1.06|||Mixed effect model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo|||-1.06|-6.48|0.008
72372456|NCT01798849|144255470|OTHER||Difference in LS means|-1.77||||0.201|TWO_SIDED|95.0|-4.51|0.98|||Mixed effect model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo|||0.98|-4.51|0.201
72372457|NCT01798849|144255470|OTHER||Difference in LS means|-4.74||||0.001|TWO_SIDED|95.0|-7.37|-2.11|||Mixed effect model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo|||-2.11|-7.37|0.001
72372458|NCT01798849|144255471|OTHER||Difference in LS means|-2.53||||0.042|TWO_SIDED|95.0|-4.97|-0.1|||Mixed effect model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo|||-0.10|-4.97|0.042
72372459|NCT01798849|144255471|OTHER||Difference in LS means|-3.29||||0.01|TWO_SIDED|95.0|-5.71|-0.88|||Mixed effect model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo|||-0.88|-5.71|0.010
72372460|NCT01798849|144255471|OTHER||Difference in LS means|-6.42|||<|0.0001|TWO_SIDED|95.0|-8.94|-3.89|||Mixed effect model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo|||-3.89|-8.94|<0.0001
72372461|NCT01798849|144255471|OTHER||Difference in LS means|-8.28|||<|0.0001|TWO_SIDED|95.0|-11.32|-5.25|||Mixed effect model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo|||-5.25|-11.32|<0.0001
72372462|NCT01798849|144255472|OTHER||Difference in LS means|0.54||||0.638|TWO_SIDED|95.0|-1.8|2.87|||Mixed effect model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo|||2.87|-1.80|0.638
72372463|NCT01798849|144255472|OTHER||Difference in LS means|0.72||||0.616|TWO_SIDED|95.0|-2.2|3.63|||Mixed effect model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo|||3.63|-2.20|0.616
72372464|NCT01798849|144255472|OTHER||Difference in LS means|2.33||||0.041|TWO_SIDED|95.0|0.11|4.56|||Mixed effect model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo|||4.56|0.11|0.041
72372465|NCT01798849|144255472|OTHER||Difference in LS means|9.14|||<|0.0001|TWO_SIDED|95.0|6.98|11.3|||Mixed effect model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo|||11.30|6.98|<0.0001
72372466|NCT01798849|144255473|OTHER||Difference in LS means|-0.65||||0.677|TWO_SIDED|95.0|-3.81|2.52|||Mixed effect model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo|||2.52|-3.81|0.677
72372467|NCT01798849|144255473|OTHER||Difference in LS means|-0.92||||0.554|TWO_SIDED|95.0|-4.08|2.24|||Mixed effect model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo|||2.24|-4.08|0.554
72372468|NCT01798849|144255473|OTHER||Difference in LS means|-2.29||||0.137|TWO_SIDED|95.0|-5.35|0.78|||Mixed effect model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo|||0.78|-5.35|0.137
72372469|NCT01798849|144255473|OTHER||Difference in LS means|-3.78||||0.006|TWO_SIDED|95.0|-6.37|-1.19|||Mixed effect model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo|||-1.19|-6.37|0.006
72372470|NCT00750152|144255517|SUPERIORITY_OR_OTHER||one-sided p-value from CMH test|0.001||||0.025|ONE_SIDED|95.0|||||Cochran-Mantel-Haenszel|The CMH test after stratification by site compared the proportion of complete cure in NAFT-500 to that of placebo to evaluate its superiority.||"In order to compare complete cure rate in the NAFT-500 group with that in the placebo group, the following one-sided null and alternate hypotheses will be tested:~* H0: p1 \<= p0~* Ha: p1 \> p0 where p0 and p1 denote the proportion of subjects with complete cure in the placebo and NAFT-500 groups, respectively."||||0.025
72372471|NCT02140593|144255521|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.75|||<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<0.05
72372472|NCT02140593|144255522|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.0|||<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<0.05
72372473|NCT02034409|144255523|NON_INFERIORITY|For the 48-week OMERACT-OARSI response the minimally clinically significant difference is an absolute rate difference of 10% between sham and PLIUS groups. With a total sample size of 144 the probability of correctly selecting the group with the greatest OORR is at least 0.885 assuming (δ=10%) that the sham group is drawn from a population with a 50% response rate and the PLIUS group is drawn from a population with response rate of at least 60% or at most 40%.||||||||||||||||Sample size has been calculated with ranking and selection methodology, a procedure used for Phase II trials. The purpose of the procedure as applied to this study is to identify whether PLIUS has a high probability of being more effective than sham. This is accomplished by obtaining sample estimates of the outcome for the PLIUS and sham groups and determining whether the PLIUS group outcome is better by the pre-specified margin of difference.|Since the ranking and selection procedures are fundamentally different from traditional hypothesis testing, concepts of statistical significance and power have no direct analogue.|||
72493597|NCT00511355|144516388|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0||||No correction for multiple testing was made.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for age class applied on the changes from baseline.||P-value compares the change from baseline to Cycle 6 between treatment groups.||||<.0001
72372474|NCT02034409|144255524|NON_INFERIORITY|For the 48-week cartilage change outcome measure the minimally clinically significant difference is 33 μm. With a difference of 33 μm, σ=152 μm standard deviation, k=2 groups, and P=0.90 probability to obtain τ=1.8124, which we use to estimate the per-group sample size: n=σ2(τ/δ\*)2=72 or a total of 144.||||||||||||||||Sample size has been calculated with ranking and selection methodology, a procedure used for Phase II trials. The purpose of the procedure as applied to this study is to identify whether PLIUS has a high probability of being more effective than sham. This is accomplished by obtaining sample estimates of the outcome for the PLIUS and sham groups and determining whether the PLIUS group outcome is better by the pre-specified margin of difference.|Since the ranking and selection procedures are fundamentally different from traditional hypothesis testing, concepts of statistical significance and power have no direct analogue.|||
72372475|NCT01888432|144255537|NON_INFERIORITY|HO: πT - πC ≥ 0.12 vs. HA: πT - πC \< 0.12, where πT and πC are the true proportions of composite efficacy failure of tBPAR, GL, or D, (tBPAR/GL/D) at 12 months post-transplant for the respective treatment groups. The proportion of 0.12, or 12%, was pre-determined as the non-inferiority (NI) margin for composite efficacy failure.|Kaplan-Meier|-0.7|||<|0.001|TWO_SIDED|90.0|-5.2|3.7||Z-test p-value for non-inferiority test (non-inferiority margin = 12%) is for one-sided test and should be compared to 0.05 significance level.|Z-test|||non-inferior efficacy failure of the reduced tacrolimus regimen to control by rejecting the null hypothesis.||3.7|-5.2|< 0.001
72372476|NCT01888432|144255538|NON_INFERIORITY|the null hypothesis below was tested at the one-sided α = 0.05 level: H0: μT - μC ≤ -6 mL/min/1.73 m2 vs. HA: μT - μC \> -6 mL/min/1.73 m\^2, where μT and μC are the true means of change in eGFR (MDRD-4) from randomization to Month 12 post-transplant for the reduced tacrolimus group and control group, respectively.|Mean Difference (Net)|4.15|STANDARD_ERROR_OF_MEAN|2.574|<|0.001|TWO_SIDED|90.0|-0.09|8.4|||ANCOVA|||||8.40|-0.09|< 0.001
72372477|NCT01888432|144255539|OTHER||Mean Difference (Final Values)|3.25|STANDARD_ERROR_OF_MEAN|2.699|<|0.001|TWO_SIDED|90.0|-1.21|7.7|||ANCOVA|||||7.70|-1.21|<0.001
72372478|NCT01888432|144255541|OTHER|Month 12|Kaplan-Meier|-1.4|||||TWO_SIDED|90.0|-4.7|2.0|||||KM rate and 90% CI are obtained using KM probability estimates of composite efficacy failure rates and standard error derived based on Greenwood's formula.|||2.0|-4.7|
72372479|NCT01888432|144255541|OTHER|tBPAR - month 24|Kaplan-Meier|-1.2|||||TWO_SIDED|90.0|-5.1|2.6|||||KM rate and 90% CI are obtained using KM probability estimates of composite efficacy failure rates and standard error derived based on Greenwood's formula.|||2.6|-5.1|
72372480|NCT01888432|144255541|OTHER|On-treatment tBPAR - month 24|Kaplan-Meier|-2.1|||||TWO_SIDED|90.0|-5.7|1.4|||||KM rate and 90% CI are obtained using KM probability estimates of composite efficacy failure rates and standard error derived based on Greenwood's formula.|||1.4|-5.7|
72372481|NCT01888432|144255542|OTHER|Month 12|Kaplan-Meier|0.9|||||TWO_SIDED|90.0|-3.4|5.1|||||KM rate and 90% CI are obtained using KM probability estimates of composite efficacy failure rates and standard error derived based on Greenwood's formula.|||5.1|-3.4|
72372482|NCT01888432|144255542|OTHER|Month 24|Kaplan-Meier|1.0|||||TWO_SIDED|90.0|-3.6|5.6|||||KM rate and 90% CI are obtained using KM probability estimates of composite efficacy failure rates and standard error derived based on Greenwood's formula.|||5.6|-3.6|
72372483|NCT01888432|144255543|OTHER|graft loss at month 24|Kaplan-Meier|-0.8|||||TWO_SIDED|90.0|-2.1|0.5|||||KM rate and 90% CI are obtained using KM probability estimates of composite efficacy failure rates and standard error derived based on Greenwood's formula.|||0.5|-2.1|
72372484|NCT01888432|144255544|OTHER|Month 12|Kaplan-Meier|0.7|||||TWO_SIDED|90.0|-2.5|3.8|||||KM rate and 90% CI are obtained using KM probability estimates of composite efficacy failure rates and standard error derived based on Greenwood's formula.|||3.8|-2.5|
72372485|NCT01888432|144255544|OTHER|Month 24|Kaplan-Meier|2.3|||||TWO_SIDED|90.0|-2.1|6.6|||||KM rate and 90% CI are obtained using KM probability estimates of composite efficacy failure rates and standard error derived based on Greenwood's formula.|||6.6|-2.1|
72372486|NCT01888432|144255545|OTHER|Month 12|Kaplan-Meier|0.7|||||TWO_SIDED|90.0|-2.5|3.8|||||KM rate and 90% CI are obtained using KM probability estimates of composite efficacy failure rates and standard error derived based on Greenwood's formula.|||3.8|-2.5|
72372487|NCT01888432|144255545|OTHER|Month 24|Kaplan-Meier|3.0|||||TWO_SIDED|90.0|-1.1|7.2|||||KM rate and 90% CI are obtained using KM probability estimates of composite efficacy failure rates and standard error derived based on Greenwood's formula.|||7.2|-1.1|
72372488|NCT01888432|144255545|OTHER|Month 24 (On-treatment death)|Kaplan-Meier|0.7|||||TWO_SIDED|90.0|-2.5|3.9|||||KM rate and 90% CI are obtained using KM probability estimates of composite efficacy failure rates and standard error derived based on Greenwood's formula.|||3.9|-2.5|
72372489|NCT01888432|144255546|OTHER||Risk Difference (RD)|0.7|||||TWO_SIDED|90.0|-3.9|5.3|||||Month 12|||5.3|-3.9|
72372490|NCT01888432|144255546|OTHER||Risk Difference (RD)|2.1|||||TWO_SIDED|90.0|-3.0|7.2|||||Month 24|||7.2|-3.0|
72372491|NCT01888432|144255547|OTHER||Risk Ratio (RR)|-0.7|||||TWO_SIDED|90.0|-4.5|3.1|||||Month 12|||3.1|-4.5|
72372492|NCT01888432|144255547|OTHER||Risk Ratio (RR)|0.0|||||TWO_SIDED|90.0|-4.2|4.2|||||Month 24|||4.2|-4.2|
72372493|NCT01888432|144255551|OTHER||Difference in Kaplan-Meier estimate|5.4|||||TWO_SIDED|95.0|-19.9|30.6|||||Composite endpoint|||30.6|-19.9|
72372494|NCT01888432|144255551|OTHER||Difference in Kaplan-Meier estimate|6.7|||||TWO_SIDED|95.0|-6.0|19.3|||||On-treatment composite endpoint|||19.3|-6.0|
72372495|NCT01888432|144255551|OTHER||Difference in Kaplan-Meier estimate|2.0|||||TWO_SIDED|95.0|-24.6|28.7|||||Graft loss/death|||28.7|-24.6|
72372496|NCT01888432|144255551|OTHER||Difference in Kaplan-Meier estimate|14.4|||||TWO_SIDED|95.0|-4.2|33.1|||||tBPAR|||33.1|-4.2|
72372497|NCT01888432|144255551|OTHER||Difference in Kaplan-Meier estimate|11.1|||||TWO_SIDED|95.0|-9.4|31.6|||||Death|||31.6|-9.4|
72372498|NCT01888432|144255551|OTHER||Difference in Kaplan-Meier estimate|3.2|||||TWO_SIDED|95.0|-28.9|35.2|||||AR|||35.2|-28.9|
72372499|NCT01888432|144255551|OTHER||Difference in Kaplan-Meier estimate|14.4|||||TWO_SIDED|95.0|-4.2|33.1|||||tAR|||33.1|-4.2|
72372500|NCT01888432|144255551|OTHER||Difference in Kaplan-Meier estimate|14.9|||||TWO_SIDED|95.0|-22.3|52.1|||||BPR|||52.1|-22.3|
72372501|NCT01888432|144255551|OTHER||Difference in Kaplan-Meier estimate|3.2|||||TWO_SIDED|95.0|-28.9|35.2|||||BPAR|||35.2|-28.9|
72372502|NCT01888432|144255552|OTHER||Mean Difference (Final Values)|-10.01|STANDARD_ERROR_OF_MEAN|22.059|||TWO_SIDED|95.0|-59.91|39.89||||||||39.89|-59.91|
72372503|NCT03054129|144255553|SUPERIORITY|||||||0.866|||||||Wilcoxon (Mann-Whitney)|||||||0.866
72372504|NCT03054129|144255554|SUPERIORITY|||||||0.361|||||||Wilcoxon (Mann-Whitney)|||||||0.361
72372505|NCT03054129|144255555|SUPERIORITY|||||||0.565|||||||Wilcoxon (Mann-Whitney)|||||||0.565
72372506|NCT03054129|144255556|OTHER|||||||0|||||||Wilcoxon (Mann-Whitney)|||||||0.000
72372507|NCT03054129|144255557|OTHER|||||||0|||||||Wilcoxon (Mann-Whitney)|||||||0.000
72372508|NCT03054129|144255558|SUPERIORITY|||||||0.357|||||||Wilcoxon (Mann-Whitney)|||||||0.357
72372509|NCT03054129|144255559|SUPERIORITY|||||||0.715|||||||Wilcoxon (Mann-Whitney)|||||||0.715
72372510|NCT03054129|144255560|SUPERIORITY|||||||0.978|||||||Wilcoxon (Mann-Whitney)|||||||0.978
72372511|NCT03054129|144255561|SUPERIORITY|||||||0.191|||||||Wilcoxon (Mann-Whitney)|||||||0.191
72372512|NCT03054129|144255562|SUPERIORITY|||||||0.097|||||||Wilcoxon (Mann-Whitney)|||||||0.097
72372513|NCT03054129|144255563|SUPERIORITY|||||||0.339|||||||Wilcoxon (Mann-Whitney)|||||||0.339
72372514|NCT03054129|144255564|SUPERIORITY|||||||0.016|||||||Wilcoxon (Mann-Whitney)|||||||0.016
72372515|NCT03054129|144255565|SUPERIORITY|||||||0.933|||||||Wilcoxon (Mann-Whitney)|||||||0.933
72372516|NCT03054129|144255566|SUPERIORITY|||||||0.136|||||||Wilcoxon (Mann-Whitney)|||||||0.136
72372517|NCT03054129|144255567|SUPERIORITY|||||||0.673|||||||Wilcoxon (Mann-Whitney)|||||||0.673
72372518|NCT03054129|144255568|SUPERIORITY|||||||0.715|||||||Wilcoxon (Mann-Whitney)|||||||0.715
72372519|NCT03054129|144255569|SUPERIORITY|||||||0.04|||||||Wilcoxon (Mann-Whitney)|||||||0.040
72372520|NCT03054129|144255570|SUPERIORITY|||||||0.779|||||||Wilcoxon (Mann-Whitney)|||||||0.779
72372521|NCT03054129|144255571|SUPERIORITY|||||||0.152|||||||Wilcoxon (Mann-Whitney)|||||||0.152
72372522|NCT03054129|144255572|SUPERIORITY|||||||0.129|||||||Wilcoxon (Mann-Whitney)|||||||0.129
72372523|NCT03054129|144255573|SUPERIORITY|||||||0.384|||||||Wilcoxon (Mann-Whitney)|||||||0.384
72372524|NCT03054129|144255574|SUPERIORITY|||||||0.978|||||||Wilcoxon (Mann-Whitney)|||||||0.978
72372525|NCT03054129|144255575|SUPERIORITY|||||||0.715|||||||Wilcoxon (Mann-Whitney)|||||||0.715
72372526|NCT03054129|144255576|SUPERIORITY|||||||0.546|||||||Wilcoxon (Mann-Whitney)|||||||0.546
72372527|NCT03054129|144255577|SUPERIORITY|||||||0.933|||||||Wilcoxon (Mann-Whitney)|||||||0.933
72372528|NCT03054129|144255578|SUPERIORITY|||||||0.684|||||||Wilcoxon (Mann-Whitney)|||||||0.684
72372529|NCT03054129|144255579|SUPERIORITY|||||||0.112|||||||Wilcoxon (Mann-Whitney)|||||||0.112
72372530|NCT03054129|144255580|SUPERIORITY|||||||0.012|||||||Wilcoxon (Mann-Whitney)|||||||0.012
72372531|NCT03054129|144255581|SUPERIORITY|||||||0.633|||||||Wilcoxon (Mann-Whitney)|||||||0.633
72372532|NCT03054129|144255582|SUPERIORITY|||||||0.736|||||||Wilcoxon (Mann-Whitney)|||||||0.736
72372533|NCT03054129|144255583|SUPERIORITY|||||||0.227|||||||Wilcoxon (Mann-Whitney)|||||||0.227
72372534|NCT03054129|144255584|SUPERIORITY|||||||0.109|||||||Wilcoxon (Mann-Whitney)|||||||0.109
72372535|NCT03054129|144255585|SUPERIORITY|||||||0.844|||||||Wilcoxon (Mann-Whitney)|||||||0.844
72372536|NCT03054129|144255586|SUPERIORITY|||||||0.122|||||||Wilcoxon (Mann-Whitney)|||||||0.122
72372537|NCT03054129|144255587|SUPERIORITY|||||||0.715|||||||Wilcoxon (Mann-Whitney)|||||||0.715
72372538|NCT03054129|144255588|SUPERIORITY|||||||0.593|||||||Wilcoxon (Mann-Whitney)|||||||0.593
72372539|NCT03054129|144255589|SUPERIORITY|||||||0.508|||||||Wilcoxon (Mann-Whitney)|||||||0.508
72372540|NCT00130247|144255590|NON_INFERIORITY_OR_EQUIVALENCE|This two-sided equivalence trial compared the efficacy of 4 and 6 months of treatment. We assumed that the risk of relapse for patients in the 6 month arm was 3.5% and that an absolute difference of 5% (i.e. relapse rate of 8.5%) was clinically meaningful. For a level of significance of 0.05 and 80% power (two sided), we estimated that 284 evaluable subjects per arm were required.|Risk Difference (RD)|0.051||||||95.0|0.01|0.09|||Regression, Cox||Confidence interval for difference of binomial proportions adjusted with Hauck Anderson continuity correction.|Comparison of binomial proportion of relapse: Intention-to-treat||0.09|0.01|
72372541|NCT00130247|144255593|SUPERIORITY_OR_OTHER||Incidence rate ratio|3.43||||||95.0|0.94|12.5|||Regression, Linear|||Rate of relapse at 1 year. All patients adherent with treatment and remaining in follow-up at 1 year were included in the calculation of the relapse incidence rate.||12.5|0.94|
72372542|NCT00130247|144255593|SUPERIORITY_OR_OTHER||Incident rate ratio|4.52||||||95.0|1.29|15.9|||Regression, Linear|||Rate of relapse at 2 years. All patients adherent with treatment and remaining in follow-up at 2 years were included in the calculation of the relapse incidence rate.||15.9|1.29|
72372543|NCT00130247|144255599|NON_INFERIORITY_OR_EQUIVALENCE|This two-sided equivalence trial compared the efficacy of 4 and 6 months of treatment. We assumed that the risk of relapse for patients in the 6 month arm was 3.5% and that an absolute difference of 5% (i.e. relapse rate of 8.5%) was clinically meaningful. For a level of significance of 0.05 and 80% power (two sided), we estimated that 284 evaluable subjects per arm were required.|Risk Difference (RD)|0.054||||||95.0|0.01|0.1|||Regression, Cox||Confidence interval for difference of binomial proportions adjusted with Hauck Anderson continuity correction.|||0.10|0.01|
72372544|NCT02123251|144255601|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.41|STANDARD_ERROR_OF_MEAN|0.2139||0.0553|TWO_SIDED|95.0|-0.0092|0.8293|||Generalized Estimating Equation Model|The analysis adjusted for the effects of age, race, gender, and baseline hypertension.|The estimates denote the differences between longitudinal changes within the treatment group and longitudinal changes within the control group.|Generalized estimating equation (GEE) modeling was used to examine the pre- and post-intervention changes between groups due to interventions in biometric indicators. The average change in scores over time for the intervention group was compared to that for the control group. The difference-in-differences values was assessed for significance at p = 0.05. Null hypothesis assumed no differences in the biometric measure from baseline to endpoint between groups.||0.8293|-0.0092|0.0553
72372545|NCT02123251|144255602|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.2916|STANDARD_ERROR_OF_MEAN|1.9571||0.2416|TWO_SIDED|95.0|-6.1274|1.5442|||Generalized Estimating Equation Model||The estimates denote the differences between longitudinal changes within the treatment group and longitudinal changes within the control group.|Generalized estimating equation (GEE) modeling was used to examine the pre- and post-intervention changes between groups due to interventions in biometric indicators. The average change in scores over time for the intervention group was compared to that for the control group. The difference-in-differences values was assessed for significance at p = 0.05. Null hypothesis assumed no differences in the biometric measure from baseline to endpoint between groups.||1.5442|-6.1274|0.2416
72372546|NCT02123251|144255603|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0893|STANDARD_ERROR_OF_MEAN|1.2622||0.3881|TWO_SIDED|95.0|-3.5632|1.3846|||Generalized Estimating Equation Model|The analysis adjusted for the effects of age, gender, race, and hypertension at baseline.|The estimates denote the differences between longitudinal changes within the treatment group and longitudinal changes within the control group.|Generalized estimating equation (GEE) modeling was used to examine the pre- and post-intervention changes between groups due to interventions in biometric indicators. The average change in scores over time for the intervention group was compared to that for the control group. The difference-in-differences values was assessed for significance at p = 0.05. Null hypothesis assumed no differences in the biometric measure from baseline to endpoint between groups.||1.3846|-3.5632|0.3881
72372547|NCT02123251|144255604|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.3432|STANDARD_ERROR_OF_MEAN|7.7086||0.8617|TWO_SIDED|95.0|-16.4517|13.7653|||Generalized Estimating Equation Model|The analysis adjusted for the effects of age, gender, race, and hypertension at baseline.|The estimates denote the differences between longitudinal changes within the treatment group and longitudinal changes within the control group.|Generalized estimating equation (GEE) modeling was used to examine the pre- and post-intervention changes between groups due to interventions in biometric indicators. The average change in scores over time for the intervention group was compared to that for the control group. The difference-in-differences values was assessed for significance at p = 0.05. Null hypothesis assumed no differences in the biometric measure from baseline to endpoint between groups.||13.7653|-16.4517|0.8617
72372548|NCT02123251|144255605|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.787|STANDARD_ERROR_OF_MEAN|28.5519||0.5333|TWO_SIDED|95.0|-73.7478|38.1737|||Generalized Estimating Equation Model|The analysis adjusted for the effects of age, gender, race, and hypertension at baseline.|The estimates denote the differences between longitudinal changes within the treatment group and longitudinal changes within the control group.|Generalized estimating equation (GEE) modeling was used to examine the pre- and post-intervention changes between groups due to interventions in biometric indicators. The average change in scores over time for the intervention group was compared to that for the control group. The difference-in-differences values was assessed for significance at p = 0.05. Null hypothesis assumed no differences in the biometric measure from baseline to endpoint between groups.||38.1737|-73.7478|0.5333
72372549|NCT02123251|144255606|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.9097|STANDARD_ERROR_OF_MEAN|5.2351||0.862|TWO_SIDED|95.0|-9.3509|11.1702|||Generalized Estimating Equation Model|The analysis adjusted for the effects of age, gender, race, and hypertension at baseline.|The estimates denote the differences between longitudinal changes within the treatment group and longitudinal changes within the control group.|Generalized estimating equation (GEE) modeling was used to examine the pre- and post-intervention changes between groups due to interventions in biometric indicators. The average change in scores over time for the intervention group was compared to that for the control group. The difference-in-differences values was assessed for significance at p = 0.05. Null hypothesis assumed no differences in the biometric measure from baseline to endpoint between groups.||11.1702|-9.3509|0.8620
72372550|NCT02123251|144255607|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.7177|STANDARD_ERROR_OF_MEAN|1.0433||0.4915|TWO_SIDED|95.0|-1.3272|2.7626|||Generalized Estimating Equation Model|The analysis adjusted for the effects of age, gender, race, and hypertension at baseline.|The estimates denote the differences between longitudinal changes within the treatment group and longitudinal changes within the control group.|Generalized estimating equation (GEE) modeling was used to examine the pre- and post-intervention changes between groups due to interventions in biometric indicators. The average change in scores over time for the intervention group was compared to that for the control group. The difference-in-differences values was assessed for significance at p = 0.05. Null hypothesis assumed no differences in the biometric measure from baseline to endpoint between groups.||2.7626|-1.3272|0.4915
72372551|NCT02123251|144255608|SUPERIORITY_OR_OTHER||||||>|0.05|||||||standard diffs-in-diffs model|||A standard diffs-in-diffs model was utilized to estimate the causal effect of the intervention on medical costs per patient/day. The average change in cost over time for the intervention group was compared to that for the control group. The difference-in-differences values was assessed for significance at p = 0.05. Null hypothesis assumed no difference in the cost per patient per day from baseline to endpoint between groups.||||>0.05
72372552|NCT02123251|144255609|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.6403|STANDARD_ERROR_OF_MEAN|0.3148||0.042|TWO_SIDED|95.0|0.0233|1.2572|||Generalized Estimating Equation Model||The estimates denote the differences between longitudinal changes within the treatment group and longitudinal changes within the control group.|The average change in scores over time for the intervention group was compared to that for the control group. The difference in these average changes is referred to as the difference-in-differences values which was assessed for significance at p = 0.05. Null hypothesis assumed no difference in the General Diet subscale from baseline to endpoint between groups. Generalized estimating equation modeling was used to examine changes in SDSCA between groups at different time points.||1.2572|0.0233|0.0420
72372553|NCT02123251|144255610|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.1188|STANDARD_ERROR_OF_MEAN|1.031||0.0399|TWO_SIDED|95.0|0.0981|4.1395|||Generalized Estimating Equation Model|The effect of age and gender is adjusted in the GEE model.|The estimates denote the differences between longitudinal changes within the treatment group and longitudinal changes within the control group.|The average change in scores over time for the intervention group was compared to that of the control group. The difference in the average changes is referred to as the difference-in-differences values which was assessed for significance at p=0.05. Null assumed no group difference in the Physical Component Summary measure of SF-36v2 from baseline to midpoint. Generalized estimating equation (GEE) modeling was used to examine changes in health measures between groups at different time points.||4.1395|0.0981|.0399
72395049|NCT02700815|144296596|SUPERIORITY||Mean Difference (Net)|0.31|STANDARD_ERROR_OF_MEAN|0.601||0.6094|TWO_SIDED|95.0|-0.87|1.49|||Mixed Models Analysis||The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|A Mixed Model Repeat Measures (MMRM) analysis was used to compare change in PA from baseline between capsaicin and combination therapy diclofenac + capsaicin. MMRM model included fixed effects of treatment, country, application site (back/neck), time and fixed covariates of baseline PA and baseline PA by time interaction.||1.49|-0.87|0.6094
72372554|NCT01235598|144255617|SUPERIORITY_OR_OTHER||Median difference within group changes|-1.5||||0.049|TWO_SIDED|95.0|-3.0|0.0||Two-sided p-value is presented, with p \< 0.05 as the threshold for statistical significance.|Permutation test with general scores||Hodges-Lehmann estimate of median difference and associated exact 95 % 2-sided confidence interval are provided.|A fixed-sequence stepwise hypothesis testing procedure was followed using a pre-specified set of ordered hypotheses. Hypotheses were ordered and tested in that order, beginning with change from Baseline at Week 16, and continuing to earlier time points (Week 8, 4, 2, 1 in that order) only if the previous null hypothesis of zero difference was rejected (p \<0.05). Hypothesis testing was stopped if and when a non-significant result was obtained.||0.0|-3.0|0.049
72372555|NCT01235598|144255618|SUPERIORITY_OR_OTHER||Median Difference within group changes|-1.0||||0.206|TWO_SIDED|95.0|-3.0|1.0||Two-sided p-value is presented, with p \< 0.05 as the threshold for statistical significance. A fixed-sequence stepwise hypothesis testing procedure was followed using a pre-specified set of ordered hypotheses.|Permutation test with general scores||Hodges-Lehmann estimate of median difference and associated exact 95 % 2-sided confidence interval are provided.|A fixed-sequence stepwise hypothesis testing procedure was followed using a pre-specified set of ordered hypotheses. Hypotheses were ordered and tested in that order, beginning with change from Baseline at Week 16, and continuing to earlier time points (Week 8, 4, 2, 1 in that order) only if the previous null hypothesis of zero difference was rejected (p \< 0.05). Hypothesis testing was stopped if and when a non-significant result was obtained. Testing was stopped in the next step.||1.0|-3.0|0.206
72372556|NCT01235598|144255622|SUPERIORITY_OR_OTHER||Median difference within group changes|-0.0035||||0.164|TWO_SIDED|95.0|-0.012|0.0025||Two-sided p-value is presented, with p \<0.05 as the threshold for statistical significance. A fixed-sequence stepwise hypothesis testing procedure was followed using a pre-specified set of ordered hypotheses.|Permutation test with general scores||Hodges-Lehmann estimate of median difference and associated exact 95 % 2-sided confidence interval are provided.|A fixed-sequence stepwise hypothesis testing procedure was followed using a pre-specified set of ordered hypotheses. Hypotheses were ordered and tested in that order, beginning with change from Baseline at Week 16, and continuing to earlier time points (Week 8, 4, 2, 1 in that order) only if the previous null hypothesis of zero difference was rejected (p \<0.05). Hypothesis testing was stopped if and when a non-significant result was obtained.||0.0025|-0.0120|0.164
72372557|NCT01235598|144255623|SUPERIORITY_OR_OTHER||Median difference within group changes|-0.069||||0.865|TWO_SIDED|95.0|-0.201|0.138||Two-sided p-value is presented, with p \<0.05 as the threshold for statistical significance. A fixed-sequence stepwise hypothesis testing procedure was followed using a pre-specified set of ordered hypotheses.|Permutation test with general scores||Hodges-Lehmann estimate of median difference and associated exact 95 % 2-sided confidence interval are provided.|A fixed-sequence stepwise hypothesis testing procedure was followed using a pre-specified set of ordered hypotheses. Hypotheses were ordered and tested in that order, beginning with change from Baseline at Week 16, and continuing to earlier time points (Week 8, 4, 2, 1 in that order) only if the previous null hypothesis of zero difference was rejected (p \<0.05). Hypothesis testing was stopped if and when a non-significant result was obtained.||0.1380|-0.2010|0.865
72372558|NCT01235598|144255624|SUPERIORITY_OR_OTHER||Median difference within group changes|-421.5||||0.015|TWO_SIDED|95.0|-1542.5|-47.0||Two-sided p-value is presented, with p \<0.05 as the threshold for statistical significance. A fixed-sequence stepwise hypothesis testing procedure was followed using a pre-specified set of ordered hypotheses.|Permutation test with general scores||Hodges-Lehmann estimate of median difference and associated exact 95 % 2-sided confidence interval are provided.|A fixed-sequence stepwise hypothesis testing procedure was followed using a pre-specified set of ordered hypotheses. Hypotheses were ordered and tested in that order, beginning with change from Baseline at Week 16, and continuing to earlier time points (Week 8, 4, 2, 1 in that order) only if the previous null hypothesis of zero difference was rejected (p \<0.05). Hypothesis testing was stopped if and when a non-significant result was obtained.||-47.0|-1542.5|0.015
72372559|NCT01235598|144255636|SUPERIORITY_OR_OTHER|||||||0.394|||||||Spearman rank correlation|||||||0.394
72372560|NCT01235598|144255637|SUPERIORITY_OR_OTHER|||||||0.625|TWO_SIDED||||||Spearman rank correlation|||||||0.625
72372561|NCT01235598|144255638|SUPERIORITY_OR_OTHER|||||||0.128|TWO_SIDED||||||Spearman rank correlation|||||||0.128
72372562|NCT01235598|144255639|SUPERIORITY_OR_OTHER|||||||0.732|TWO_SIDED||||||Spearman rank correlation|||||||0.732
72372563|NCT01235598|144255640|SUPERIORITY_OR_OTHER|||||||0.411|TWO_SIDED||||||Spearman rank correlation|||||||0.411
72372564|NCT01235598|144255641|SUPERIORITY_OR_OTHER|||||||0.208|TWO_SIDED||||||Spearman rank correlation|||||||0.208
72372565|NCT01235598|144255642|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.0||||0.254|TWO_SIDED|95.0|-1.0|0.0||Two-sided p-value is presented, with p \<0.05 as the threshold for statistical significance.|Wilcoxon Rank-Sum Test||Hodges-Lehmann estimate of median difference and associated exact 95 % 2-sided confidence interval are provided.|||0.0|-1.0|0.254
72372566|NCT01235598|144255643|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.0||||0.472|TWO_SIDED|95.0|-2.0|1.0||Two-sided p-value is presented, with p \<0.05 as the threshold for statistical significance.|Wilcoxon Rank-Sum Test||Hodges-Lehmann estimate of median difference and associated exact 95 % 2-sided confidence interval are provided.|||1.0|-2.0|0.472
72372567|NCT00395343|144255646|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.56|||<|0.001||95.0|-0.7|-0.42|||ANCOVA|Model terms: treatment; baseline; metformin stratum (on vs. not on metformin); insulin stratum (pre-mixed vs. intermediate or long-acting)||||-0.42|-0.70|<0.001
72372568|NCT00395343|144255647|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-15.0|||<|0.001||95.0|-23.4|-6.5|||ANCOVA|Model terms: treatment; baseline; metformin stratum; insulin stratum||||-6.5|-23.4|<0.001
72372569|NCT00395343|144255648|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-36.1|||<|0.001||95.0|-47.1|-25.1|||ANCOVA|Model terms: treatment; baseline; metformin stratum; insulin stratum||||-25.1|-47.1|<0.001
72372570|NCT00395343|144255649|SUPERIORITY_OR_OTHER||Geometric Mean Difference|36.5||||0.01||95.0|8.9|64.7|||ANCOVA|Model terms: treatment; log-scaled baseline value; metformin stratum; insulin stratum||||64.7|8.9|0.01
72372571|NCT00395343|144255650|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.6|||<|0.001||95.0|1.89|6.85||Based on a test of the odds ratio = 1, comparing the odds of having A1C \<7.0% at Week 24 in the Sitagliptin 100 mg q.d. group vs. the Placebo group.|Logistic Regression|Model terms: treatment; baseline; Metformin stratum; and insulin stratum||||6.85|1.89|<0.001
72372572|NCT00395343|144255651|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.37||||0.584||95.0|0.45|4.18||Based on a test of the odds ratio = 1, comparing the odds of having A1C \<7.0% at Week 24 in the Sitagliptin 100 mg q.d. group vs. the Placebo group.|Logistic Regression|Model terms: treatment; baseline; Metformin stratum; and insulin stratum|This parameter estimate and 95% confidence interval correspond to the odds of having A1C \<6.5% at Week 24 in the Sitagliptin 100 mg q.d. group vs. the Placebo group.|||4.18|0.45|0.584
72432399|NCT00614744|144377188|SUPERIORITY|This trial estimated the probability that the intervention has no effect on the outcome (or conversely, the probability that it does), given the data obtained in the trial and any prior evidence.|Risk Ratio (RR)|0.86|||||TWO_SIDED|95.0|0.59|1.29|||Bayesian log binomial models|Bayesian log binomial models were used to analyze the primary outcome of death or moderate/severe disability.|In log binomial models used Normal (0, sd=0.35) neutral prior in the log RR scale. Estimation used Normal weakly informative priors. Reported posterior medians \& 95% credible intervals for the RR above instead of confidence intervals.|Whole-body Hypothermia vs. Normothermia (Normothermia is the comparison group)|"We fitted all Bayesian models via Markov chain Monte Carlo methods (MCMC) using JAGS (version 3.4) and OpenBUGS (3.2.3) in R (version 3.2.5). For each analysis we ran 3 MCMC chains with starting values randomly drawn from the estimated parameters from a frequentist log binomial model. A burn-in of 1,000 iterations was used, with sampling from a further 10,000 iterations for each chain. To monitor convergence, trace plots and the Gelman-Rubin convergence diagnostic (Rhat) were used for all parameters.~For all analyses, the trace plots show good mixing of the 3 chains with Rhat \< 1.01 for all parameters, indicating convergence."|1.29|0.59|
72432400|NCT03005288|144377219|SUPERIORITY||Mean Difference (Net)|-7.31|||<|0.001|TWO_SIDED|80.0|-8.48|-6.14|||Mixed-Effect Model Repeated Measure|||||-6.14|-8.48|<0.001
72432401|NCT03005288|144377220|SUPERIORITY||Mean Difference (Net)|-5.19|||<|0.001|TWO_SIDED|80.0|-6.01|-4.37|||Mixed-Effect Model Repeated Measure|||||-4.37|-6.01|<0.001
72372573|NCT00395343|144255652|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.56|||<|0.001||95.0|-0.72|-0.4|||ANCOVA|Model terms: treatment; baseline; metformin stratum; insulin stratum, treatment by insulin stratum interaction||||-0.40|-0.72|<0.001
72372574|NCT03255629|144255693|OTHER|||||||0.103|||||||McNemar|||||||0.103
72372575|NCT03255629|144255694|OTHER|||||||0.18|||||||McNemar|||||||0.180
72432402|NCT03005288|144377221|SUPERIORITY||Mean Difference (Net)|-1.13|||<|0.001|TWO_SIDED|80.0|-1.42|-0.83|||Mixed Models Analysis|||week 24||-0.83|-1.42|<0.001
72372576|NCT03255629|144255696|OTHER|||||||0.317|||||||McNemar|||||||0.317
72372577|NCT03255629|144255697|OTHER|||||||0.008|||||||McNemar|||||||0.008
72372578|NCT03255629|144255698|OTHER|||||||0.083|||||||McNemar|||||||0.083
72372579|NCT03255629|144255699|OTHER|||||||0.025|||||||McNemar|||||||0.025
72372580|NCT03255629|144255701|OTHER|||||||0.049|||||||Mixed Models Analysis|Linear mixed effects models to account for correlation within subjects over time||||||0.049
72372581|NCT03255629|144255702|OTHER|||||||0.056|||||||Mixed Models Analysis|Linear mixed effects models to account for correlation within subjects over time||||||0.056
72372582|NCT03255629|144255703|OTHER|||||||0.004|||||||Mixed Models Analysis|||||||0.004
72372583|NCT03255629|144255704|OTHER|||||||0.059|||||||Mixed Models Analysis|||||||0.059
72372584|NCT03255629|144255705|OTHER|||||||0.195|||||||Mixed Models Analysis|||||||0.195
72372585|NCT03255629|144255706|OTHER|||||||0.043|||||||Mixed Models Analysis|||||||0.043
72372586|NCT03255629|144255707|OTHER|||||||0.659|||||||Mixed Models Analysis|||||||0.659
72372587|NCT03255629|144255708|OTHER|||||||0.406|||||||Mixed Models Analysis|||||||0.406
72372588|NCT03255629|144255709|OTHER|||||||0.611|||||||Mixed Models Analysis|||||||0.611
72372589|NCT03255629|144255710|OTHER|||||||0.183|||||||Mixed Models Analysis|||||||0.183
72372590|NCT03255629|144255711|OTHER|||||||0.009|||||||Mixed Models Analysis|||||||0.009
72372591|NCT03255629|144255712|OTHER|||||||0.789|||||||Mixed Models Analysis|||||||0.789
72372592|NCT03255629|144255713|OTHER|||||||0.865|||||||McNemar|||||||0.865
72432403|NCT03005288|144377221|SUPERIORITY||Mean Difference (Net)|-0.8||||0.005|TWO_SIDED|80.0|-1.2|-0.41|||Mixed Models Analysis|||week 48||-0.41|-1.20|0.005
72432404|NCT03005288|144377225|SUPERIORITY||Mean Difference (Net)|-1.33|||<|0.001|TWO_SIDED|80.0|-1.71|-0.95|||Mixed-Effect Model Repeated Measure|||week 24||-0.95|-1.71|<0.001
72432405|NCT03005288|144377225|SUPERIORITY||Mean Difference (Net)|-1.91|||<|0.001|TWO_SIDED|80.0|-2.48|-1.34|||Mixed-Effect Model Repeated Measure|||week 48||-1.34|-2.48|<0.001
72432406|NCT03005288|144377226|SUPERIORITY||Mean Difference (Net)|-3.43|||<|0.001|TWO_SIDED|80.0|-4.54|-2.31|||Mixed-Effect Model Repeated Measure|||week 24||-2.31|-4.54|<0.001
72432407|NCT03005288|144377226|SUPERIORITY||Mean Difference (Net)|-5.1|||<|0.001|TWO_SIDED|80.0|-6.74|-3.47|||Mixed-Effect Model Repeated Measure|||week 48||-3.47|-6.74|<0.001
72432408|NCT03005288|144377227|SUPERIORITY||Mean Difference (Net)|1.49||||0.003|TWO_SIDED|80.0|0.82|2.06|||Mixed-Effect Model Repeated Measure|||week 24||2.06|0.82|0.003
72372593|NCT03255629|144255714|OTHER|||||||0.875|||||||McNemar|||||||0.875
72372594|NCT01776307|144255724|OTHER|Descriptive analysis for investigational arms; no comparator analysis|||||||||||||||||The exact 95% confidence interval is based on the Clopper-Pearson method.|||
72372595|NCT01776307|144255725|OTHER|Estimates provided for investigational arms; no comparator analysis|||||||||||||||||Estimated from Kaplan Meier Curve|||
72372596|NCT01776307|144255726|OTHER|Estimates provided for investigational arms; no comparator analysis|||||||||||||||||Estimated from Kaplan Meier Curve|||
72372597|NCT03615040|144255739|SUPERIORITY||Incidence Rate Ratio|0.78|STANDARD_ERROR_OF_MEAN|0.15||0.195|TWO_SIDED|95.0|0.53|1.14|||t-test, 2 sided|||A generalised linear model (assuming neg. binomial distribution) was used. The model includes the number of exacerbations during the 48 week treatment as an outcome with explanatory variables of treatment arm \& number of exacerbations in the 12 months prior to the trial (stratification factor), and log-time on trial (in weeks) as an offset. The offset, allows for different lengths of time in the trial. Only observed exacerbations were used alongside the corresponding time period in the offset.||1.14|0.53|0.195
72372598|NCT03615040|144255742|SUPERIORITY||Mean Difference (Net)|-3.3||||0.039|TWO_SIDED|95.0|-6.4|-0.2|||Mixed Models Analysis|||Calculated using mixed effect linear model with dependent variable of the outcome at baseline and follow-up time points (Week 4, 12, 24, 36, 48); explanatory variables of treatment arm, number of exacerbations in the 12 months prior to the trial (stratification factor), visit time point (as categorical variable), baseline score; an interaction term between treatment and visit as fixed effects; and patient identification as a random effect.||-0.2|-6.4|0.039
72372599|NCT03615040|144255743|SUPERIORITY||Mean Difference (Net)|0.53||||0.469|TWO_SIDED|95.0|-0.91|2.0|||Mixed Models Analysis|||Calculated using mixed effect linear model with dependent variable of the outcome at baseline and follow-up time points (Week 4, 12, 24, 36, 48); explanatory variables of treatment arm, number of exacerbations in the 12 months prior to the trial (stratification factor), visit time point (as categorical variable), baseline score; an interaction term between treatment and visit as fixed effects; and patient identification as a random effect.||2.00|-0.91|0.469
72372600|NCT03615040|144255744|SUPERIORITY|||||||0.9|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank sum test of mMRC dyspnoea Week 4||||0.90
72372601|NCT03615040|144255744|SUPERIORITY|||||||0.95|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank sum test of mMRC dyspnoea Week 12||||0.95
72372602|NCT03615040|144255744|SUPERIORITY|||||||0.78|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank sum test of mMRC dyspnoea Week 24||||0.78
72372603|NCT03615040|144255744|SUPERIORITY|||||||0.88|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank sum test of mMRC dyspnoea Week 36||||0.88
72372604|NCT03615040|144255744|SUPERIORITY|||||||0.78|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank sum test of mMRC dyspnoea Week 48||||0.78
72372605|NCT03615040|144255745|SUPERIORITY||Mean Difference (Net)|-9.4||||0.236|TWO_SIDED|95.0|-24.9|6.2||Using mixed effect linear model with explanatory variables treatment, number of exacerbations in the 12 months prior to the trial (stratification), visit time point (as categorical variable) and baseline score as fixed effects.|Mixed Models Analysis|||VAS total||6.2|-24.9|0.236
72372606|NCT03615040|144255745|SUPERIORITY||Mean Difference (Net)|-4.9||||0.083|TWO_SIDED|95.0|-10.6|0.7||Using mixed effect linear model with explanatory variables treatment, number of exacerbations in the 12 months prior to the trial (stratification), visit time point (as categorical variable) and baseline score as fixed effects.|Mixed Models Analysis|||VAS Dyspnoea||0.7|-10.6|0.083
72372607|NCT03615040|144255745|SUPERIORITY||Mean Difference (Net)|-2.1||||0.546|TWO_SIDED|95.0|-8.9|4.7||Using mixed effect linear model with explanatory variables treatment, number of exacerbations in the 12 months prior to the trial (stratification), visit time point (as categorical variable) and baseline score as fixed effects.|Mixed Models Analysis|||VAS Cough||4.7|-8.9|0.546
72432409|NCT03005288|144377227|SUPERIORITY||Mean Difference (Net)|2.14|||<|0.001|TWO_SIDED|80.0|1.36|2.93|||Mixed-Effect Model Repeated Measure|||week 48||2.93|1.36|<0.001
72372608|NCT03615040|144255745|SUPERIORITY||Mean Difference (Net)|-1.9||||0.527|TWO_SIDED|95.0|-7.8|4.0||Using mixed effect linear model with explanatory variables treatment, number of exacerbations in the 12 months prior to the trial (stratification), visit time point (as categorical variable) and baseline score as fixed effects.|Mixed Models Analysis|||VAS Sputum production||4.0|-7.8|0.527
72372609|NCT03615040|144255746|SUPERIORITY|||||||0.84|||||||Wilcoxon (Mann-Whitney)|||sputum purulence colour card Week 12||||0.84
72372610|NCT03615040|144255746|SUPERIORITY|||||||0.52|||||||Wilcoxon (Mann-Whitney)|||sputum purulence colour card Week 24||||0.52
72432410|NCT03005288|144377228|SUPERIORITY||Mean Difference (Net)|-4.09|||<|0.001|TWO_SIDED|80.0|-5.26|-2.92|||Mixed-Effect Model Repeated Measure|||week 24||-2.92|-5.26|<0.001
72372611|NCT03615040|144255746|SUPERIORITY|||||||0.82|||||||Wilcoxon (Mann-Whitney)|||sputum purulence colour card Week 36||||0.82
72372612|NCT03615040|144255746|SUPERIORITY|||||||0.95|||||||Wilcoxon (Mann-Whitney)|||sputum purulence colour card Week 48||||0.95
72372613|NCT03615040|144255747|SUPERIORITY||Mean Difference (Final Values)|9.06||||0.069|TWO_SIDED|95.0|-0.83|18.97|||ANCOVA|||Pre BD FEV1/FVC ratio: Analysis of covariance (ANCOVA) adjusting for the baseline value||18.97|-0.83|0.069
72372614|NCT03615040|144255748|SUPERIORITY||Mean Difference (Net)|0.04||||0.094|TWO_SIDED|95.0|-0.01|0.09|||Mixed Models Analysis|||mixed effect linear model with explanatory variables of treatment arm, number of exacerbations in the 12 months prior to the trial (stratification factor), visit time point (as categorical variable), baseline score and patient identification as a random effect to account for repeated measures over time was fitted for each outcome. Adjusted mean difference between treatment arms with 95% confidence interval and p-value were reported. In the modified ITT population.||0.09|-0.01|0.094
72372615|NCT03615040|144255749|SUPERIORITY||Mean Difference (Final Values)|0.03||||0.905|TWO_SIDED|95.0|-0.46|0.52||To compare change from baseline to 48 weeks (pre and post treatment measurements), analysis of covariance (ANCOVA) model with baseline value as a covariate was fitted. Adjusted mean difference with 95% confidence interval and p-value were reported.|ANCOVA|||Total Lung Capacity||0.52|-0.46|0.905
72372616|NCT03615040|144255749|SUPERIORITY||Mean Difference (Final Values)|-0.08||||0.775|TWO_SIDED|95.0|-0.62|0.47||To compare change from baseline to 48 weeks (pre and post treatment measurements), analysis of covariance (ANCOVA) model with baseline value as a covariate was fitted. Adjusted mean difference with 95% confidence interval and p-value were reported.|ANCOVA|||Residual Volume||0.47|-0.62|0.775
72372617|NCT03615040|144255750|SUPERIORITY||Geometric mean ratio|1.01||||0.736|TWO_SIDED|95.0|0.95|1.07||"Outcome was log transformed~Explanatory variables:~treatment arm, number of exacerbations in the 12 months prior to the trial (stratification factor), log BL value, visit time point (categorical) and patient identification (random effect)."|Mixed Models Analysis|||White blood cell count||1.07|0.95|0.736
72372618|NCT03615040|144255750|SUPERIORITY||Geometric mean ratio|0.59|||<|0.001|TWO_SIDED|95.0|0.51|0.69||"Outcome was log transformed~Explanatory variables:~treatment arm, number of exacerbations in the 12 months prior to the trial (stratification factor), log BL value, visit time point (categorical) and patient identification (random effect)."|Mixed Models Analysis|||Eosinophil Count||0.69|0.51|<0.001
72372619|NCT03615040|144255750|SUPERIORITY||Geometric mean ratio|1.02||||0.678|TWO_SIDED|95.0|0.93|1.13||"Outcome was log transformed~Explanatory variables:~treatment arm, number of exacerbations in the 12 months prior to the trial (stratification factor), log BL value, visit time point (categorical) and patient identification (random effect)."|Mixed Models Analysis|||Neutrophil Count||1.13|0.93|0.678
72432411|NCT03005288|144377228|SUPERIORITY||Mean Difference (Net)|-9.46|||<|0.001|TWO_SIDED|80.0|-11.3|-7.64|||Mixed-Effect Model Repeated Measure|||week 52||-7.64|-11.3|<0.001
72432412|NCT03005288|144377229|SUPERIORITY||Mean Difference (Net)|-0.02||||0.062|TWO_SIDED|80.0|-0.03|0.0|||Mixed-Effect Model Repeated Measure|||week 24||-0.00|-0.03|0.062
72432413|NCT03005288|144377229|SUPERIORITY||Mean Difference (Net)|-0.06|||<|0.001|TWO_SIDED|80.0|-0.08|-0.04|||Mixed-Effect Model Repeated Measure|||week 52||-0.04|-0.08|<0.001
72432414|NCT03005288|144377230|SUPERIORITY||Mean Difference (Net)|-0.65||||0.028|TWO_SIDED|80.0|-1.03|-0.28|||Mixed-Effect Model Repeated Measure|||week 12||-0.28|-1.03|0.028
72372620|NCT03615040|144255751|SUPERIORITY||Geometric mean ratio|0.25|||<|0.001|TWO_SIDED|95.0|0.19|0.33||A mixed effect linear model of the log outcome with explanatory variables treatment, number of exacerbations in the 12 months prior to the trial (stratification), visit time point (as categorical variable) and log baseline score as fixed effects.|Mixed Models Analysis|||Eosinophil count||0.33|0.19|<0.001
72372621|NCT03615040|144255767|SUPERIORITY||Mean Difference (Final Values)|0.11||||0.362|TWO_SIDED|95.0|-0.14|0.35|||ANCOVA|||Pre BD FVC (litres): Analysis of covariance (ANCOVA) adjusting for the baseline value||0.35|-0.14|0.362
72372622|NCT03615040|144255767|SUPERIORITY||Mean Difference (Final Values)|-0.09||||0.713|TWO_SIDED|95.0|-0.61|0.44|||ANCOVA|||Pre BD FVC (litre):Analysis of covariance (ANCOVA) adjusting for the baseline value||0.44|-0.61|0.713
72372623|NCT03615040|144255768|SUPERIORITY||Mean Difference (Final Values)|1.78||||0.711|TWO_SIDED|95.0|-8.63|12.2|||ANCOVA|||Pre FEV1 predicted: Analysis of covariance (ANCOVA) adjusting for the baseline value||12.20|-8.63|0.711
72372624|NCT03615040|144255768|SUPERIORITY||Mean Difference (Final Values)|-10.4||||0.214|TWO_SIDED|95.0|-27.9|7.1|||ANCOVA|||Pre BD FVC predicted (%): Analysis of covariance (ANCOVA) adjusting for the baseline value||7.1|-27.9|0.214
72372625|NCT03615040|144255769|SUPERIORITY||Mean Difference (Final Values)|-2.95||||0.201|TWO_SIDED|95.0|-7.53|1.65||To compare change from baseline to 48 weeks (pre and post treatment measurements), analysis of covariance (ANCOVA) model with baseline value as a covariate was fitted. Adjusted mean difference with 95% confidence interval and p-value were reported.|ANCOVA|||Residual Volume/Total Lung Capacity ratio.||1.65|-7.53|0.201
72372626|NCT03615040|144255770|SUPERIORITY||Geometric mean ratio|0.75||||0.114|TWO_SIDED|95.0|0.52|1.07||A mixed effect linear model of the log outcome with explanatory variables treatment, number of exacerbations in the 12 months prior to the trial (stratification), visit time point (as categorical variable) and log baseline score as fixed effects|Mixed Models Analysis|||Macrophage count||1.07|0.52|0.114
72372627|NCT03615040|144255771|SUPERIORITY||Geometric mean ratio|0.79||||0.215|TWO_SIDED|95.0|0.54|1.15||A mixed effect linear model of the log outcome with explanatory variables treatment, number of exacerbations in the 12 months prior to the trial (stratification), visit time point (as categorical variable) and log baseline score as fixed effects.|Mixed Models Analysis|||Epithelium count||1.15|0.54|0.215
72372628|NCT04074161|144255795|SUPERIORITY|Responses were analysed using an analysis of covariance model with randomized treatment as factor and baseline body weight as covariate.|Treatment difference|-9.38|||<|0.0001|TWO_SIDED|95.0|-11.97|-6.8|||ANCOVA|||||-6.80|-11.97|<0.0001
72372629|NCT03232333|144255888|SUPERIORITY||||||=|0.71|||||||t-test, 1 sided|||||||=0.71
72372630|NCT03232333|144255889|SUPERIORITY||||||=|0.63|||||||t-test, 1 sided|||||||=0.63
72372631|NCT03232333|144255890|SUPERIORITY||||||=|0.01|||||||t-test, 1 sided|||||||=.01
72372632|NCT01419197|144255923|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.528|||<|0.0001|TWO_SIDED|95.0|0.422|0.661||The two-sided stratified log-rank test was used to compare progression-free survival between the two treatment arms at the overall two-sided significance level of 0.5%.|Log Rank||The hazard ratio was estimated by Cox regression.|The analysis was stratified for 1) World region (United States, Western Europe, or Other); 2) Number of prior regimens, excluding single-agent hormones, for treatment of metastatic or unresectable locally advanced/recurrent disease (≤ 3 or \> 3); and 3) Presence of visceral disease (any visceral disease vs no visceral disease).||0.661|0.422|<0.0001
72372633|NCT01419197|144255924|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.552||||0.0034|TWO_SIDED|95.0|0.369|0.826||The 2-sided stratified log-rank test was used at the overall two-sided significance level of 4.5%. The pre-specified O'Brien-Fleming stopping boundary for this first OS interim analysis was HR\<0.363 (p-value \< 0.0000013).|Log Rank||The hazard ratio was estimated by Cox regression.|The analysis was stratified for 1) World region (United States, Western Europe, or Other); 2) Number of prior regimens, excluding single-agent hormones, for treatment of metastatic or unresectable locally advanced/recurrent disease (≤ 3 or \> 3); and 3) Presence of visceral disease (any visceral disease vs no visceral disease).||0.826|0.369|0.0034
72372634|NCT01419197|144255925|SUPERIORITY_OR_OTHER||Difference in Response Percentage|22.7|||<|0.0001|TWO_SIDED|95.0|16.2|29.2|||Mantel Haenszel|||The analysis was stratified for 1) World region (United States, Western Europe, or Other); 2) Number of prior regimens, excluding single-agent hormones, for treatment of metastatic or unresectable locally advanced/recurrent disease (≤ 3 or \> 3); and 3) Presence of visceral disease (any visceral disease vs no visceral disease).||29.2|16.2|<0.0001
72372635|NCT01419197|144255927|SUPERIORITY_OR_OTHER||Difference in Survival Percentage|12.6||||0.0011|TWO_SIDED|95.0|5.03|20.09||The p-value for the difference in survival rate was derived from the z-test using the standard errors computed using Greenwood's method.|z-test|||6-month survival||20.09|5.03|0.0011
72372636|NCT01419197|144255927|SUPERIORITY_OR_OTHER||Difference in Survival Percentage|11.7||||0.1805|TWO_SIDED|95.0|-5.41|28.75||The p-value for the difference in survival rates was derived from the z-test using the standard errors computed using Greenwood's method.|z-test|||1-year survival||28.75|-5.41|0.1805
72372637|NCT01419197|144255928|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.115||||0.4952|TWO_SIDED|95.0|0.819|1.517|||Log Rank|||The analysis was stratified for 1) World region (United States, Western Europe, or Other); 2) Number of prior regimens, excluding single-agent hormones, for treatment of metastatic or unresectable locally advanced/recurrent disease (≤ 3 or \> 3); and 3) Presence of visceral disease (any visceral disease vs no visceral disease).||1.517|0.819|0.4952
72372638|NCT01419197|144255930|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.677||||0.0007|TWO_SIDED|95.0|0.539|0.85||The two-sided stratified log-rank test was used at the overall two-sided significance level of 4.5%. The pre-specified O'Brien-Fleming stopping boundary for this second and final interim analysis was HR\<0.748 (p value \< 0.012).|Log Rank||The hazard ratio was estimated by Cox regression.|The analysis was stratified for 1) World region (United States, Western Europe, or Other); 2) Number of prior regimens, excluding single-agent hormones, for treatment of metastatic or unresectable locally advanced/recurrent disease (≤ 3 or \> 3); and 3) Presence of visceral disease (any visceral disease versus no visceral disease).||0.850|0.539|0.0007
72372639|NCT01419197|144255931|SUPERIORITY_OR_OTHER||Difference in Survival Percentage|12.4||||0.0003|TWO_SIDED|95.0|5.67|19.14||The p-value for the difference in survival rate was derived from the z-test using the standard errors computed using Greenwood's method.|z-test|||6-month survival||19.14|5.67|0.0003
72432415|NCT03005288|144377230|SUPERIORITY||Mean Difference (Net)|-0.66||||0.081|TWO_SIDED|80.0|-1.14|-0.18|||Mixed-Effect Model Repeated Measure|||week 36||-0.18|-1.14|0.081
72432416|NCT03824236|144377234|OTHER|Vaccine efficacy rate was calculated as 100\*(1-RR) with RR=relative risk of developing the disease for vaccinated people (P-Fx Group) compared to unvaccinated people (Infectivity Control Group).|Vaccine efficacy rate|52.0||||0.003|TWO_SIDED|95.0|28.0|68.0|||Fisher Exact|||Efficacy analysis aimed at comparing P. falciparum parasitemia incidence after sporozoite challenge between P-Fx group and the Infectivity Control group.||68|28|0.003
72432417|NCT03824236|144377234|OTHER|Vaccine efficacy rate was calculated as 100\*(1-RR) with RR=relative risk of developing the disease for vaccinated people (NP-Fx Group) compared to unvaccinated people (Infectivity Control Group).|Vaccine efficacy rate|54.0||||0.002|TWO_SIDED|95.0|29.0|70.0|||Fisher Exact|||Efficacy analysis aimed at comparing P. falciparum parasitemia incidence after sporozoite challenge between NP-Fx group and the Infectivity Control group.||70|29|0.002
72432418|NCT01140347|144377260|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.866||||0.1391|TWO_SIDED|95.0|0.717|1.046|||Log Rank||HR with 95% confidence interval (CI) was estimated using a stratified Cox proportional hazards regression model using the Interactive Web Response System (IWRS) stratification factors (geographical regions and etiology of liver disease).|||1.046|0.717|0.1391
72372640|NCT01419197|144255931|SUPERIORITY_OR_OTHER||Difference in Survival Percentage|11.0||||0.0104|TWO_SIDED|95.0|2.58|19.33||The p-value for the difference in survival rates was derived from the z-test using the standard errors computed using Greenwood's method.|z-test|||1-year survival||19.33|2.58|0.0104
72372641|NCT01099449|144255945|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Two-sample t-tests or Wilcoxon rank-sum tests will be used as in\>\> primary analysis.||||||0.73|||||||Wilcoxon (Mann-Whitney)|||Two-sample t-tests or Wilcoxon rank-sum tests will be used\>\> to compare the AUC of CIPN sensory subscale between each of the two schedules of\>\> Ca/Mg infusions vs placebo arms at the 2.5% significance level. If the CIPN sensory\>\> subscales are observed to be unbalanced, we will adjust for the baseline CIPN sensory\>\> subscale scores from the AUC or incorporate them as a covariate in generalized linear\>\> regression model.||||.73
72372642|NCT01099449|144255945|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Two-sample t-tests or Wilcoxon rank-sum tests will be used as in\>\> primary analysis.||||||0.29|||||||Wilcoxon (Mann-Whitney)|||Two-sample t-tests or Wilcoxon rank-sum tests will be used\>\> to compare the AUC of CIPN sensory subscale between each of the two schedules of\>\> Ca/Mg infusions vs placebo arms at the 2.5% significance level. If the CIPN sensory\>\> subscales are observed to be unbalanced, we will adjust for the baseline CIPN sensory\>\> subscale scores from the AUC or incorporate them as a covariate in generalized linear\>\> regression model.||||.29
72372643|NCT01099449|144255946|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Two-sample t-tests or Wilcoxon rank-sum tests will be used as in\>\> primary analysis.||||||0.054|||||||Wilcoxon (Mann-Whitney)|||We will not adjust p-values (or significance level) for multiple\>\> comparisons among the numerous hypothesis testings of secondary endpoints due to the\>\> exploratory nature of these secondary analyses. The significance results from secondary\>\> analyses will be interpreted cautiously in a hypothesis-generating fashion.||||.054
72372644|NCT01099449|144255946|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Two-sample t-tests or Wilcoxon rank-sum tests will be used as in\>\> primary analysis.||||||0.27|||||||Wilcoxon (Mann-Whitney)|||We will not adjust p-values (or significance level) for multiple\>\> comparisons among the numerous hypothesis testings of secondary endpoints due to the\>\> exploratory nature of these secondary analyses. The significance results from secondary\>\> analyses will be interpreted cautiously in a hypothesis-generating fashion.||||.27
72372645|NCT01099449|144255947|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Two-sample t-tests or Wilcoxon rank-sum tests will be used as in\>\> primary analysis.||||||0.29|||||||Wilcoxon (Mann-Whitney)|||We will not adjust p-values (or significance level) for multiple\>\> comparisons among the numerous hypothesis testings of secondary endpoints due to the\>\> exploratory nature of these secondary analyses. The significance results from secondary\>\> analyses will be interpreted cautiously in a hypothesis-generating fashion.||||.29
72372646|NCT01099449|144255947|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Two-sample t-tests or Wilcoxon rank-sum tests will be used as in\>\> primary analysis.||||||0.25|||||||Wilcoxon (Mann-Whitney)|||We will not adjust p-values (or significance level) for multiple\>\> comparisons among the numerous hypothesis testings of secondary endpoints due to the\>\> exploratory nature of these secondary analyses. The significance results from secondary\>\> analyses will be interpreted cautiously in a hypothesis-generating fashion.||||.25
72372647|NCT01099449|144255950|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Kruskal Wallis Analysis||||||0.89|||||||Kruskal-Wallis|||||||.89
72372648|NCT01099449|144255950|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Kruskal Wallis Analysis||||||0.496|||||||Kruskal-Wallis|||||||.496
72372649|NCT01099449|144255951|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Chi-Squared Analysis||||||0.52|||||||Chi-squared|||||||.52
72372650|NCT01099449|144255951|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Chi-Squared Analysis||||||0.66|||||||Chi-squared|||||||.66
72372651|NCT00146848|144255955|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3|STANDARD_ERROR_OF_MEAN|1.75||0.86|TWO_SIDED|95.0|-3.14|3.74|||t-test, 2 sided|||The changes in quality of life were compared between groups using two-sided t-tests.||3.74|-3.14|0.86
72372652|NCT00146848|144255955|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.49|STANDARD_ERROR_OF_MEAN|1.87||0.43|TWO_SIDED|95.0|-2.18|5.16|||t-test, 2 sided|||The difference in changes in quality of life between groups were compared using a t-test.||5.16|-2.18|0.43
72372653|NCT00146848|144255956|SUPERIORITY_OR_OTHER|||||||0.55||95.0|||||Cochran-Armitage test for trend|||One sided test testing for shift towards improvement in either atrial support pacing treatment arm compared to the DDD-40 arm.||||0.55
72372654|NCT00146848|144255956|SUPERIORITY_OR_OTHER|||||||0.8||95.0|||||Cochran-Armitage test for trend|||||||0.80
72372655|NCT00146848|144255957|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.17|STANDARD_ERROR_OF_MEAN|6.35||0.11|TWO_SIDED|95.0|-22.65|2.3|||t-test, 2 sided|||Compare the difference in the changes in physical activity scores between groups using a t-test.||2.30|-22.65|0.11
72372656|NCT00146848|144255957|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.24|STANDARD_ERROR_OF_MEAN|6.55||0.04|TWO_SIDED|95.0|-26.11|-0.37|||t-test, 2 sided|||"Compare the difference in the changes in physical activity scores between groups using a t-test.~To adjust for multiple comparisons, an alpha level of 0.025 should be used to deem significance."||-0.37|-26.11|0.04
72432419|NCT01140347|144377261|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.625|||<|0.0001|TWO_SIDED|95.0|0.522|0.75|||Log Rank||HR with 95% CI was estimated using a stratified Cox proportional hazards regression model using the IWRS stratification factors (geographical regions and etiology of liver disease).|||0.750|0.522|<0.0001
72372657|NCT04556383|144255964|SUPERIORITY||Risk Difference (RD)|-2.6||||0.6694|TWO_SIDED|95.0|-15.2|10.2|||Cochran-Mantel-Haenszel||PCP GB004 480 mg QD vs Placebo.|||10.2|-15.2|0.6694
72372658|NCT04556383|144255964|SUPERIORITY||Risk Difference (RD)|4.6||||0.4719|TWO_SIDED|95.0|-9.0|17.8|||Cochran-Mantel-Haenszel||PCP GB004 480 mg BID vs Placebo.|||17.8|-9.0|0.4719
72372659|NCT04556383|144255966|SUPERIORITY||Risk Difference (RD)|-7.7||||0.3263|TWO_SIDED|95.0|-23.2|8.3|||Cochran-Mantel-Haenszel||PCP GB004 480 mg QD vs Placebo.|||8.3|-23.2|0.3263
72372660|NCT04556383|144255966|SUPERIORITY||Risk Difference (RD)|10.2||||0.2002|TWO_SIDED|95.0|-6.1|25.8|||Cochran-Mantel-Haenszel||PCP GB004 480 mg BID vs Placebo.|||25.8|-6.1|0.2002
72372661|NCT04556383|144255967|SUPERIORITY||Risk Difference (RD)|0.4||||0.9472|TWO_SIDED|95.0|-15.2|15.9|||Cochran-Mantel-Haenszel||PCP GB004 480 mg QD vs Placebo.|||15.9|-15.2|0.9472
72372662|NCT04556383|144255967|SUPERIORITY||Risk Difference (RD)|6.8||||0.3685|TWO_SIDED|95.0|-9.3|22.4|||Cochran-Mantel-Haenszel||PCP GB004 480 mg BID vs Placebo.|||22.4|-9.3|0.3685
72372663|NCT04556383|144255968|SUPERIORITY||Risk Difference (RD)|1.3||||0.8484|TWO_SIDED|95.0|-12.7|15.2|||Cochran-Mantel-Haenszel||PCP GB004 480 mg QD vs Placebo.|||15.2|-12.7|0.8484
72372664|NCT04556383|144255968|SUPERIORITY||Risk Difference (RD)|8.2||||0.2392|TWO_SIDED|95.0|-6.4|22.3|||Cochran-Mantel-Haenszel||PCP GB004 480 mg BID vs Placebo.|||22.3|-6.4|0.2392
72372665|NCT04556383|144255969|SUPERIORITY||Risk Difference (RD)|-1.2||||0.8493|TWO_SIDED|95.0|-14.8|12.5|||Cochran-Mantel-Haenszel||PCP GB004 480 mg QD vs Placebo.|||12.5|-14.8|0.8493
72372666|NCT04556383|144255969|SUPERIORITY||Risk Difference (RD)|2.6||||0.6647|TWO_SIDED|95.0|-11.5|16.5|||Cochran-Mantel-Haenszel||PCP GB004 480 mg BID vs Placebo.|||16.5|-11.5|0.6647
72372667|NCT04556383|144255970|SUPERIORITY||Risk Difference (RD)|-6.5||||0.2263|TWO_SIDED|95.0|-19.1|6.0|||Cochran-Mantel-Haenszel||PCP GB004 480 mg QD vs Placebo.|||6.0|-19.1|0.2263
72372668|NCT04556383|144255970|SUPERIORITY||Risk Difference (RD)|-1.4||||0.8259|TWO_SIDED|95.0|-14.8|12.2|||Cochran-Mantel-Haenszel||PCP GB004 480 mg BID vs Placebo.|||12.2|-14.8|0.8259
72372669|NCT04556383|144255971|SUPERIORITY||Risk Difference (RD)|2.8||||0.7418|TWO_SIDED|95.0|-12.7|18.1|||Cochran-Mantel-Haenszel||PCP GB004 480 mg QD vs Placebo.|||18.1|-12.7|0.7418
72372670|NCT04556383|144255971|SUPERIORITY||Risk Difference (RD)|8.4||||0.2758|TWO_SIDED|95.0|-7.8|24.2|||Cochran-Mantel-Haenszel||PCP GB004 480 mg BID vs Placebo.|||24.2|-7.8|0.2758
72372671|NCT04556383|144255972|SUPERIORITY||Risk Difference (RD)|-6.0||||0.3504|TWO_SIDED|95.0|-20.6|8.9|||Cochran-Mantel-Haenszel||PCP GB004 480 mg QD vs Placebo.|||8.9|-20.6|0.3504
72372672|NCT04556383|144255972|SUPERIORITY||Risk Difference (RD)|1.7||||0.8009|TWO_SIDED|95.0|-14.2|17.5|||Cochran-Mantel-Haenszel||PCP GB004 480 mg BID vs Placebo.|||17.5|-14.2|0.8009
72372673|NCT04556383|144255973|SUPERIORITY||Risk Difference (RD)|-0.2||||0.9474|TWO_SIDED|95.0|-14.3|13.7|||Cochran-Mantel-Haenszel||PCP GB004 480 mg QD vs Placebo.|||13.7|-14.3|0.9474
72372674|NCT04556383|144255973|SUPERIORITY||Risk Difference (RD)|-3.0||||0.6409|TWO_SIDED|95.0|-16.6|10.8|||Cochran-Mantel-Haenszel||PCP GB004 480 mg BID vs Placebo.|||10.8|-16.6|0.6409
72372675|NCT04556383|144255974|SUPERIORITY||Risk Difference (RD)|-8.0||||0.1932|TWO_SIDED|95.0|-22.4|6.3|||Cochran-Mantel-Haenszel||PCP GB004 480 mg QD vs Placebo.|||6.3|-22.4|0.1932
72372676|NCT04556383|144255974|SUPERIORITY||Risk Difference (RD)|-2.3||||0.7459|TWO_SIDED|95.0|-17.6|12.9|||Cochran-Mantel-Haenszel||PCP GB004 480 mg BID vs Placebo.|||12.9|-17.6|0.7459
72372677|NCT00119678|144255979|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.1|||||TWO_SIDED|95.0|0.7|1.5|||||Cox proportional-hazards model was used to estimate the hazard ratio of abatacept versus placebo for SLE disease flare. The 95% two-sided confidence interval was provided for the hazard ratio for treatment.|||1.5|0.7|
72372678|NCT00509145|144256023|SUPERIORITY||Risk Ratio (RR)|0.77|STANDARD_ERROR_OF_MEAN|0.066||0.0024|TWO_SIDED|95.0|0.65|0.911|||Over-dispersed Poisson Regression||Laquinimod 0.6 mg vs. placebo|Response variable: number of relapses during 24 months. Offset based on the log of subject's exposure in years was employed to adjust for variability of treatment exposure. In addition to the treatment group, the Poisson regression model included the following covariates: baseline EDSS score, log of prior 2-year number of relapses+1 and Country or Geographical Region (CGR).||0.911|0.650|0.0024
72372679|NCT01994889|144256028|SUPERIORITY|||||||0.0006|||||||Finkelstein-Schoenfeld Method|||||||0.0006
72372680|NCT01994889|144256029|SUPERIORITY||Hazard Ratio (HR)|0.698||||0.0259|TWO_SIDED|95.0|0.508|0.958|||Cox proportional hazards model||Hazard ratio from a Cox proportional hazards model with treatment, TTR genotype (variant and wild-type) and New York Heart Association (NYHA) baseline classification (NYHA Classes I and II combined and NYHA Class III) in the model.|||0.958|0.508|0.0259
72372681|NCT01994889|144256030|SUPERIORITY||Risk Ratio (RR)|0.6761|||<|0.0001|TWO_SIDED|95.0|0.5639|0.8107||Poisson regression analysis with treatment, TTR genotype, NYHA baseline classification, treatment-by-TTR genotype interaction, and treatment-by-NYHA baseline classification interaction terms as factors adjusted for treatment duration.|Poisson regression analysis|||||0.8107|0.5639|<0.0001
72372682|NCT01994889|144256031|SUPERIORITY||Least Square Mean Difference|75.68|STANDARD_ERROR_OF_MEAN|9.236|<|0.0001|TWO_SIDED|95.0|57.56|93.8|||Mixed Model Repeated Measures ANCOVA|||L.S. means are from an ANCOVA (MMRM) model with an unstructured covariance matrix; center and participant within center as random effects; treatment, visit, TTR genotype (variant and wild-type), and visit by treatment interaction, as fixed effects and baseline score as covariate.||93.80|57.56|<.0001
72372683|NCT01994889|144256032|SUPERIORITY||LS Mean Difference|13.65|STANDARD_ERROR_OF_MEAN|2.13|<|0.0001|TWO_SIDED|95.0|9.48|17.83|||Mixed Model Repeated Measures ANCOVA|||Change at Month 30||17.83|9.48|<.0001
72372684|NCT01994889|144256033|SUPERIORITY||Hazard Ratio (HR)|0.691||||0.0383|TWO_SIDED|95.0|0.488|0.98|||Cox proportional hazards model||Hazard ratio from a Cox proportional hazards model with treatment, TTR genotype (variant and wild-type) and NYHA baseline classification (NYHA Classes I and II combined and NYHA Class III) in the model.|||0.980|0.488|0.0383
72372685|NCT01994889|144256034|SUPERIORITY||||||<|0.0001|||||||Chi-squared|||||||<0.0001
72395050|NCT02700815|144296596|SUPERIORITY||Mean Difference (Net)|0.76|STANDARD_ERROR_OF_MEAN|0.602||0.2047|TWO_SIDED|95.0|-0.42|1.95|||Mixed Models Analysis||The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|A Mixed Model Repeat Measures (MMRM) analysis was used to compare change in PA from baseline between diclofenac and combination therapy diclofenac + capsaicin. MMRM model included fixed effects of treatment, country, application site (back/neck), time and fixed covariates of baseline PA and baseline PA by time interaction.||1.95|-0.42|0.2047
72372686|NCT02969655|144256050|NON_INFERIORITY|Non-inferiority was established if the lower limit of the 95% CI was greater than -1.0 g/dL. Even if the 95% CI for the difference was completely negative (i.e. lied fully within the range -1.0 to \<0 g/dL) non-inferiority was concluded on condition that the mean Hgb estimated in the daprodustat group was within the target range.|Mean Difference (Final Values)|0.06|||<|0.0001|TWO_SIDED|95.0|-0.11|0.23||The p value on this table is one-sided and calculated for the non-inferiority assessment.|Mixed model repeated measures (MMRM)||Analysis was performed by a MMRM with covariates of treatment, Baseline Hgb, visit, treatment-by-visit interaction, Baseline-by-visit interaction.|||0.23|-0.11|<.0001
72372687|NCT02969655|144256051|SUPERIORITY||Odds Ratio (OR)|0.76||||0.7442|TWO_SIDED|95.0|0.34|1.71||The p value on this table is one-sided and calculated for the superiority assessment.|Regression, Logistic||Analysis was performed by logistic regression with covariates of treatment and Baseline Hgb.|||1.71|0.34|0.7442
72372688|NCT01711216|144256122|SUPERIORITY_OR_OTHER|||||||0.3181|TWO_SIDED|||||Test statistic (d.f.) 1.0157 (1) A Mantel-Haenszel chi-square test was used, exact p-value was computed using Monte Carlo estimation.|Mantel Haenszel|||Test of association between the number of regular menstrual cycles during the follow-up period and the number of dydrogesterone therapy cycles received during the treatment period (Follow-up Analysis Set) Follow-up Analysis Set (N=915)||||0.3181
72372689|NCT00796926|144256221|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|95.0|||||t-test, 2 sided|||||||>0.05
72372690|NCT00006289|144256237|SUPERIORITY_OR_OTHER|||||||0.0058|TWO_SIDED||||||t-test, 1 sided|||Data from 16 patients is analyzed using one-sided paired t-test without breaking treatment code (Drug A or B, without knowing which drug is Neurotropin or Placebo) to determine if (1) the study should be terminated (if 0.0058 ≤ p), (2) the study should be terminated with rejection of the null hypothesis that there are no differences between Drug A and Drug B (p ≥ 0.9), or (3) the study will be continued to obtain the total of 42 patients (0.0058 ≤ p ≤ 0.9).||||0.0058
72372691|NCT00006289|144256238|SUPERIORITY_OR_OTHER|||||||0.0058|TWO_SIDED||||||t-test, 1 sided|||Data from 16 patients is analyzed using one-sided paired t-test without breaking treatment code (Drug A or B) to determine if (1) the study should be terminated (if 0.0058 ≤ p), (2) the study should be terminated with rejection of the null hypothesis that there are no differences between Drug A and Drug B (p ≥ 0.9), or (3) the study will be continued to obtain the total of 42 patients (0.0058 ≤ p ≤ 0.9).||||0.0058
72372692|NCT00006289|144256239|SUPERIORITY_OR_OTHER|||||||0.0058|TWO_SIDED||||||t-test, 1 sided|||Data from 16 patients is analyzed using one-sided paired t-test without breaking treatment code (Drug A or B) to determine if (1) the study should be terminated (if 0.0058 ≤ p), (2) the study should be terminated with rejection of the null hypothesis that there are no differences between Drug A and Drug B (p ≥ 0.9), or (3) the study will be continued to obtain the total of 42 patients (0.0058 ≤ p ≤ 0.9).||||0.0058
72372693|NCT02043808|144256242|SUPERIORITY_OR_OTHER||Crude event rate ratio|0.69|||||TWO_SIDED|95.0|0.52|0.92|||||Crude event rate ratio for dabigatran with warfarin as the reference group|||0.92|0.52|
72372694|NCT02043808|144256243|SUPERIORITY_OR_OTHER||Crude event rate ratio|0.83|||||TWO_SIDED|95.0|0.71|0.98|||||Crude event rate ratio for dabigatran with warfarin as the reference group|||0.98|0.71|
72372695|NCT02043808|144256244|SUPERIORITY_OR_OTHER||Crude event rate ratio|0.79|||||TWO_SIDED|95.0|0.59|1.07|||||Crude event rate ratio for dabigatran with warfarin as the reference group|||1.07|0.59|
72372696|NCT02043808|144256245|SUPERIORITY_OR_OTHER||Crude event rate ratio|0.31|||||TWO_SIDED|95.0|0.13|0.7|||||Crude event rate ratio for dabigatran with warfarin as the reference group|||0.70|0.13|
72372697|NCT02043808|144256246|SUPERIORITY_OR_OTHER||Crude event rate ratio|0.48|||||TWO_SIDED|95.0|0.3|0.77|||||Crude event rate ratio for dabigatran with warfarin as the reference group|||0.77|0.30|
72372698|NCT02043808|144256247|SUPERIORITY_OR_OTHER||Crude event rate ratio|0.9|||||TWO_SIDED|95.0|0.76|1.07|||||Crude event rate ratio for dabigatran with warfarin as the reference group|||1.07|0.76|
72372699|NCT02043808|144256248|SUPERIORITY_OR_OTHER||Crude event rate ratio|1.07|||||TWO_SIDED|95.0|0.89|1.3|||||Crude event rate ratio for dabigatran with warfarin as the reference group|||1.30|0.89|
72372700|NCT02043808|144256249|SUPERIORITY_OR_OTHER||Crude event rate ratio|0.72|||||TWO_SIDED|95.0|0.5|1.03|||||Crude event rate ratio for dabigatran with warfarin as the reference group|||1.03|0.50|
72372701|NCT02043808|144256250|SUPERIORITY_OR_OTHER||Crude event rate ratio|1.24|||||TWO_SIDED|95.0|0.99|1.54|||||Crude event rate ratio for dabigatran with warfarin as the reference group|||1.54|0.99|
72372702|NCT02043808|144256251|SUPERIORITY_OR_OTHER||Crude event rate ratio|0.35|||||TWO_SIDED|95.0|0.17|0.72|||||Crude event rate ratio for dabigatran with warfarin as the reference group|||0.72|0.17|
72372703|NCT02043808|144256252|SUPERIORITY_OR_OTHER||Crude event rate ratio|0.37|||||TWO_SIDED|95.0|0.22|0.64|||||Crude event rate ratio for dabigatran with warfarin as the reference group|||0.64|0.22|
72372704|NCT02043808|144256253|SUPERIORITY_OR_OTHER||Crude event rate ratio|0.83|||||TWO_SIDED|95.0|0.55|1.26|||||Crude event rate ratio for dabigatran with warfarin as the reference group|||1.26|0.55|
72372705|NCT02043808|144256254|SUPERIORITY_OR_OTHER||Crude event rate ratio|0.66|||||TWO_SIDED|95.0|0.45|0.95|||||Crude event rate ratio for dabigatran with warfarin as the reference group|||0.95|0.45|
72372706|NCT02043808|144256255|SUPERIORITY_OR_OTHER||Crude event rate ratio|0.64|||||TWO_SIDED|95.0|0.31|1.31|||||Crude event rate ratio for dabigatran with warfarin as the reference group|||1.31|0.31|
72372707|NCT02043808|144256256|SUPERIORITY_OR_OTHER||Crude event rate ratio|0.44|||||TWO_SIDED|95.0|0.16|1.21|||||Crude event rate ratio for dabigatran with warfarin as the reference group|||1.21|0.16|
72372708|NCT02043808|144256257|SUPERIORITY_OR_OTHER||Crude event rate ratio|0.97|||||TWO_SIDED|95.0|0.34|2.81|||||Crude event rate ratio for dabigatran with warfarin as the reference group|||2.81|0.34|
72372709|NCT02043808|144256258|SUPERIORITY_OR_OTHER||Crude event rate ratio|0.6|||||TWO_SIDED|95.0|0.52|0.69|||||Crude event rate ratio for dabigatran with warfarin as the reference group|||0.69|0.52|
72372710|NCT00966875|144256302|SUPERIORITY_OR_OTHER|||||||0.031|TWO_SIDED|||||A log transformed dose was used in the model.|Regression, Logistic|||||||0.031
72372711|NCT00966875|144256303|SUPERIORITY_OR_OTHER|||||||0.033|TWO_SIDED||||||Fisher Exact|||||||0.033
72372712|NCT00966875|144256303|SUPERIORITY_OR_OTHER|||||||0.047|||||||Fisher Exact|||||||0.047
72372713|NCT00966875|144256307|SUPERIORITY_OR_OTHER|||||||0.013||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||0.013
72372714|NCT00966875|144256307|SUPERIORITY_OR_OTHER|||||||0.004||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||0.004
72372715|NCT00966875|144256307|SUPERIORITY_OR_OTHER||||||<|0.001||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||<0.001
72372716|NCT00966875|144256307|SUPERIORITY_OR_OTHER||||||<|0.001||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||<0.001
72372717|NCT00966875|144256307|SUPERIORITY_OR_OTHER||||||<|0.001||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||<0.001
72372718|NCT00966875|144256307|SUPERIORITY_OR_OTHER||||||<|0.001||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||<0.001
72372719|NCT00966875|144256307|SUPERIORITY_OR_OTHER||||||<|0.001||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||<0.001
72372720|NCT00966875|144256309|SUPERIORITY_OR_OTHER|||||||0.227|TWO_SIDED|||||P-value is for ACR20-NRI at Week 12.|Fisher Exact|||||||0.227
72372721|NCT00966875|144256309|SUPERIORITY_OR_OTHER|||||||0.306|TWO_SIDED|||||P-value is for ACR20-NRI at Week 12.|Fisher Exact|||||||0.306
72372722|NCT00966875|144256309|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED|||||P-value is for ACR20-NRI at Week 12.|Fisher Exact|||||||0.001
72372723|NCT00966875|144256309|SUPERIORITY_OR_OTHER|||||||0.07|TWO_SIDED|||||P-value is for ACR20-NRI at Week 12.|Fisher Exact|||||||0.070
72372724|NCT00966875|144256309|SUPERIORITY_OR_OTHER|||||||0.058|TWO_SIDED|||||P-value is for ACR20-NRI at Week 12.|Fisher Exact|||||||0.058
72372725|NCT00966875|144256309|SUPERIORITY_OR_OTHER|||||||0.033|TWO_SIDED|||||P-value is for ACR20-NRI at Week 12.|Fisher Exact|||||||0.033
72372726|NCT00966875|144256309|SUPERIORITY_OR_OTHER|||||||0.047|TWO_SIDED|||||P-value is for ACR20-NRI at Week 12.|Fisher Exact|||||||0.047
72372727|NCT00966875|144256309|SUPERIORITY_OR_OTHER|||||||0.191|TWO_SIDED|||||P-value is for ACR50-NRI at Week 12.|Fisher Exact|||||||0.191
72372728|NCT00966875|144256309|SUPERIORITY_OR_OTHER|||||||0.019|TWO_SIDED|||||P-value is for ACR50-NRI at Week 12.|Fisher Exact|||||||0.019
72372729|NCT00966875|144256309|SUPERIORITY_OR_OTHER|||||||0.013|TWO_SIDED|||||P-value is for ACR50-NRI at Week 12.|Fisher Exact|||||||0.013
72372730|NCT00966875|144256309|SUPERIORITY_OR_OTHER|||||||0.017|TWO_SIDED|||||P-value is for ACR50-NRI at Week 12.|Fisher Exact|||||||0.017
72372731|NCT00966875|144256309|SUPERIORITY_OR_OTHER|||||||0.026|TWO_SIDED|||||P-value is for ACR50-NRI at Week 12.|Fisher Exact|||||||0.026
72372732|NCT00966875|144256309|SUPERIORITY_OR_OTHER|||||||0.039|TWO_SIDED|||||P-value is for ACR50-NRI at Week 12.|Fisher Exact|||||||0.039
72372733|NCT00966875|144256309|SUPERIORITY_OR_OTHER|||||||0.102|TWO_SIDED|||||P-value is for ACR50-NRI at Week 12.|Fisher Exact|||||||0.102
72372734|NCT00966875|144256309|SUPERIORITY_OR_OTHER|||||||0.388|TWO_SIDED|||||P-value is for ACR70-NRI at Week 12.|Fisher Exact|||||||0.388
72372735|NCT00966875|144256309|SUPERIORITY_OR_OTHER|||||||0.033|TWO_SIDED|||||P-value is for ACR70-NRI at Week 12.|Fisher Exact|||||||0.033
72372736|NCT00966875|144256309|SUPERIORITY_OR_OTHER|||||||0.039|TWO_SIDED|||||P-value is for ACR70-NRI at Week 12.|Fisher Exact|||||||0.039
72372737|NCT00966875|144256309|SUPERIORITY_OR_OTHER|||||||0.199|TWO_SIDED|||||P-value is for ACR70-NRI at Week 12.|Fisher Exact|||||||0.199
72372738|NCT00966875|144256309|SUPERIORITY_OR_OTHER|||||||0.039|TWO_SIDED|||||P-value is for ACR70-NRI at Week 12.|Fisher Exact|||||||0.039
72372739|NCT00966875|144256309|SUPERIORITY_OR_OTHER|||||||0.696|TWO_SIDED|||||P-value is for ACR70-NRI at Week 12.|Fisher Exact|||||||0.696
72372740|NCT00966875|144256309|SUPERIORITY_OR_OTHER|||||||0.112|TWO_SIDED|||||P-value is for ACR70-NRI at Week 12.|Fisher Exact|||||||0.112
72372741|NCT00966875|144256311|SUPERIORITY_OR_OTHER|||||||0.017||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||0.017
72372742|NCT00966875|144256311|SUPERIORITY_OR_OTHER|||||||0.042||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||0.042
72372743|NCT00966875|144256311|SUPERIORITY_OR_OTHER|||||||0.004||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||0.004
72372744|NCT00966875|144256311|SUPERIORITY_OR_OTHER||||||<|0.001||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||<0.001
72372745|NCT00966875|144256311|SUPERIORITY_OR_OTHER||||||<|0.001||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||<0.001
72372746|NCT00966875|144256311|SUPERIORITY_OR_OTHER|||||||0.008||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||0.008
72372747|NCT00966875|144256311|SUPERIORITY_OR_OTHER|||||||0.007||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||0.007
72372748|NCT00966875|144256313|SUPERIORITY_OR_OTHER|||||||0.093||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||0.093
72372749|NCT00966875|144256313|SUPERIORITY_OR_OTHER|||||||0.023||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||0.023
72372750|NCT00966875|144256313|SUPERIORITY_OR_OTHER|||||||0.006||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||0.006
72372751|NCT00966875|144256313|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED|||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||0.001
72372752|NCT00966875|144256313|SUPERIORITY_OR_OTHER|||||||0.028||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||0.028
72372753|NCT00966875|144256313|SUPERIORITY_OR_OTHER||||||<|0.001||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||<0.001
72372754|NCT00966875|144256313|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||<0.001
72372755|NCT00966875|144256315|SUPERIORITY_OR_OTHER|||||||0.247||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||0.247
72372756|NCT00966875|144256315|SUPERIORITY_OR_OTHER|||||||0.315||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||0.315
72372757|NCT00966875|144256315|SUPERIORITY_OR_OTHER|||||||0.006||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||0.006
72372758|NCT00966875|144256315|SUPERIORITY_OR_OTHER|||||||0.042||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||0.042
72372759|NCT00966875|144256315|SUPERIORITY_OR_OTHER|||||||0.055||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||0.055
72372760|NCT00966875|144256315|SUPERIORITY_OR_OTHER|||||||0.365||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||0.365
72372761|NCT00966875|144256315|SUPERIORITY_OR_OTHER|||||||0.005||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||0.005
72372762|NCT00966875|144256317|SUPERIORITY_OR_OTHER|||||||0.778||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||0.778
72372763|NCT00966875|144256317|SUPERIORITY_OR_OTHER|||||||0.865||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||0.865
72432420|NCT01140347|144377262|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) adjusted for geographic region and etiology liver disease||||||<0.0001
72432421|NCT01140347|144377263|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.593|||<|0.0001|TWO_SIDED|95.0|0.487|0.722|||Log Rank||HR with 95% CI was estimated using a stratified Cox proportional hazards regression model using the IWRS stratification factors (geographical regions and etiology of liver disease).|||0.722|0.487|<0.0001
72432422|NCT01449929|144377272|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority of DTG 50 mg and DRV+RTV at Week 48 can be concluded if the lower bound of a two-sided 95% confidence interval (CI) for the difference in percentages (DTG - DRV+RTV) is greater than -12%. If non-inferiority is established, superiority can be tested at the nominal 5% level based on a pre-specified testing procedure.|Difference in percentage|7.1||||0.025|TWO_SIDED|95.0|0.9|13.2||P-value is for test of superiority.|Cochran-Mantel-Haenszel|Stratified analysis|Analysis was adjusted for the Baseline (BL) stratification factors: Baseline plasma HIV-1 RNA (\<=100,000 c/mL vs \>100,000 c/mL) and Baseline background dual NRTI therapy (ABC/3TC vs TDF/FTC).|||13.2|0.9|0.025
72432423|NCT01871285|144377291|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.182||||0.7942|TWO_SIDED|95.0|-1.6|1.24|||Mixed Models Analysis|||||1.24|-1.60|.7942
72432424|NCT01871285|144377291|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.683||||0.6155|TWO_SIDED|95.0|-11.89|13.25|||Mixed Models Analysis|||||13.25|-11.89|.6155
72432425|NCT01871285|144377292|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.182||||0.7942|TWO_SIDED|95.0|-1.6|1.24|||Mixed Models Analysis|||||1.24|-1.60|.7942
72432426|NCT01871285|144377292|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.683||||0.6155|TWO_SIDED|95.0|-11.89|13.25|||Mixed Models Analysis|||||13.25|-11.89|.6155
72372764|NCT00966875|144256317|SUPERIORITY_OR_OTHER|||||||0.03||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||0.030
72372765|NCT00966875|144256317|SUPERIORITY_OR_OTHER|||||||0.331||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||0.331
72432427|NCT02967016|144377295|OTHER|||||||0.002|||||||Kruskal-Wallis|||Cumulative Steps 6 h||||0.002
72372766|NCT00966875|144256317|SUPERIORITY_OR_OTHER|||||||0.039||||||P-value is for Week 12..|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||0.039
72372767|NCT00966875|144256317|SUPERIORITY_OR_OTHER|||||||0.292||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||0.292
72372768|NCT00966875|144256317|SUPERIORITY_OR_OTHER|||||||0.003||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||0.003
72372769|NCT00966875|144256319|SUPERIORITY_OR_OTHER|||||||0.09||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||0.090
72372770|NCT00966875|144256319|SUPERIORITY_OR_OTHER|||||||0.131||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||0.131
72372771|NCT00966875|144256319|SUPERIORITY_OR_OTHER|||||||0.008||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||0.008
72372772|NCT00966875|144256319|SUPERIORITY_OR_OTHER|||||||0.013||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||0.013
72372773|NCT00966875|144256319|SUPERIORITY_OR_OTHER|||||||0.01||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||0.010
72372774|NCT00966875|144256319|SUPERIORITY_OR_OTHER||||||<|0.001||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||<0.001
72372775|NCT00966875|144256319|SUPERIORITY_OR_OTHER||||||<|0.001||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||<0.001
72372776|NCT00966875|144256321|SUPERIORITY_OR_OTHER||||||<|0.001||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||<0.001
72372777|NCT00966875|144256321|SUPERIORITY_OR_OTHER|||||||0.012||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||0.012
72372778|NCT00966875|144256321|SUPERIORITY_OR_OTHER||||||<|0.001||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||<0.001
72432428|NCT02967016|144377295|OTHER|||||||0.0002|||||||Kruskal-Wallis|||Cumulative steps 12 h||||.0002
72432429|NCT02967016|144377295|OTHER|||||||0.0006|||||||Kruskal-Wallis|||Cumulative steps 24 h||||.0006
72432430|NCT02967016|144377295|OTHER|||||||0.0006|||||||Kruskal-Wallis|||Cumulative steps 36 h||||0.0006
72432431|NCT02967016|144377295|OTHER|||||||0.03|||||||Kruskal-Wallis|||Cumulative steps 48 h||||0.03
72432432|NCT02967016|144377296|OTHER|||||||0.06|||||||Kruskal-Wallis|||Pain at rest 6 h||||0.06
72432433|NCT02967016|144377296|OTHER|||||||0.3|||||||Kruskal-Wallis|||Pain at rest 12 h||||.30
72432434|NCT02967016|144377296|OTHER|||||||0.002|||||||Kruskal-Wallis|||Pain at rest 24 h||||.002
72432435|NCT02967016|144377296|OTHER|||||||0.003|||||||Kruskal-Wallis|||Pain at rest 36 h||||0.003
72432436|NCT02967016|144377296|OTHER|||||||0.02|||||||Kruskal-Wallis|||Pain at rest at 48 h||||.02
72432437|NCT02967016|144377297|OTHER|||||||0.43|||||||Kruskal-Wallis|||Satisfaction with pain control 6 h||||.43
72432438|NCT02967016|144377297|OTHER|||||||0.24|||||||Kruskal-Wallis|||Satisfaction with pain control 12 h||||.24
72432439|NCT02967016|144377297|OTHER|||||||0.012|||||||Kruskal-Wallis|||Satisfaction with pain control 24 h||||.012
72432440|NCT02967016|144377297|OTHER||||||<|0.0001|||||||Kruskal-Wallis|||Satisfaction with pain control 36 h||||<0.0001
72432441|NCT02967016|144377297|OTHER|||||||0.0005|||||||Kruskal-Wallis|||Satisfaction with pain control 48 h||||.0005
72432442|NCT01996644|144377340|SUPERIORITY_OR_OTHER|||||||0.043|TWO_SIDED||||||ANOVA|||||||.043
72432443|NCT00058058|144377373|OTHER|Estimation of diagnostic yield|Binomial proportion|0.031|STANDARD_ERROR_OF_MEAN|0.006|||TWO_SIDED|95.0|0.02|0.042||||||Diagnostic Yield is defined as the likelihood that a test or procedure will provide the information needed to establish a diagnosis. For this analysis, a Positive Test is defined as a score of BI-RADS 0, 4 or 5 based on Final BI-RADS||0.042|0.020|
72432444|NCT00058058|144377373|OTHER||Binomial Proportion|0.031|STANDARD_ERROR_OF_MEAN|0.006|||TWO_SIDED|95.0|0.021|0.044||||||Diagnostic Yield is defined as the likelihood that a test or procedure will provide the information needed to establish a diagnosis. For this analysis, a Positive Test is defined as a score of BI-RADS 4 or 5 based on initial MRI and subsequent work-up||0.044|0.021|
72432445|NCT00058058|144377373|OTHER||Binomial Proportion|0.031|STANDARD_ERROR_OF_MEAN|0.006|||TWO_SIDED|95.0|0.02|0.042||||||Diagnostic Yield is defined as the likelihood that a test or procedure will provide the information needed to establish a diagnosis. For this analysis, a Positive Test is defined as a score of BI-RADS 4 or 5 based on initial MRI and subsequent work-up and a completed biopsy procedure||0.042|0.020|
72432446|NCT00058058|144377373|OTHER||Binomial proportion|0.031|STANDARD_ERROR_OF_MEAN|0.006|||TWO_SIDED|95.0|0.02|0.042||||||Diagnostic Yield is defined as the likelihood that a test or procedure will provide the information needed to establish a diagnosis. For this analysis, a Positive Test is defined as a score of BI-RADS 0, 4 or 5 on the initial MRI scan||0.042|0.020|
72432447|NCT00058058|144377373|OTHER||Binomial Proportion|0.032|STANDARD_ERROR_OF_MEAN|0.006|||TWO_SIDED|95.0|0.021|0.043||||||Diagnostic Yield is defined as the likelihood that a test or procedure will provide the information needed to establish a diagnosis. For this analysis, a Positive Test is defined as a score of BI-RADS 0, 3, 4 or 5 on the initial MRI scan||0.043|0.021|
72432448|NCT00058058|144377373|OTHER||Binomial Proportion|0.032|STANDARD_ERROR_OF_MEAN|0.006|||TWO_SIDED|95.0|0.021|0.043||||||Diagnostic Yield is defined as the likelihood that a test or procedure will provide the information needed to establish a diagnosis. For this analysis, a Positive Test is defined as a score of BI-RADS 0, 3, 4 or 5 based on initial MRI and subsequent work-up||0.043|0.021|
72432449|NCT00058058|144377374|OTHER||Binomial Proportion|0.9091|STANDARD_ERROR_OF_MEAN|0.05004|||TWO_SIDED|95.0|0.7567|0.9809||||||"Sensitivity estimate - estimates the P(T+\|D+) where the MRI within 90 days of a negative mammogram is the test (T) and cancer in the contralateral breast is the Disease status(D)"||0.9809|0.7567|
72432450|NCT00058058|144377374|OTHER||Binomial Proportion|0.8782|STANDARD_ERROR_OF_MEAN|0.0107|||TWO_SIDED|95.0|0.8555|0.8985||||||"Specificity - estimates the P(T-\|D-) of MRI where the MRI within 90 days of a negative mammogram is the test (T) and cancer in the contralateral breast is the Disease status(D)"||0.8985|0.8555|
72432451|NCT00058058|144377374|OTHER||Binomial Proportion|0.2083|STANDARD_ERROR_OF_MEAN|0.0338|||TWO_SIDED|95.0|0.1452|0.2839||||||"PPV estimate - estimates the P(D+\|T+), where the MRI within 90 days of a negative mammogram is the test (T) and cancer in the contralateral breast is the Disease status(D)."||0.2839|0.1452|
72432452|NCT00058058|144377374|OTHER||Binomial Proportion|0.9964|STANDARD_ERROR_OF_MEAN|0.0021|||TWO_SIDED|95.0|0.9894|0.9993||||||"B. NPV Analysis for ALL Cases in Analysis Set NPV estimate - estimates the P(D-\|T-), where the MRI within 90 days of a negative mammogram is the test (T) and cancer in the contralateral breast is the Disease status(D)"||0.9993|0.9894|
72432453|NCT00058058|144377374|OTHER||Binomial Proportion|0.031|STANDARD_ERROR_OF_MEAN|0.00556|||TWO_SIDED|95.0|0.021|0.044||||||B. Diagnostic Yield for ALL Cases in Analysis Set Diagnostic Yield - estimates the likelihood that the MRI within 90 days of a negative mammogram will provide the information needed to establish a diagnosis||0.044|0.021|
72432454|NCT00058058|144377375|OTHER||ROC analysis|0.9355|||||TWO_SIDED|95.0|0.8956|0.9753|||||exact CI|ROC analysis - estimates the accuracy of MRI within 90 days of a negative mammogram to detect cancer in the contralateral breast||0.9753|0.8956|
72432455|NCT00790062|144377383|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.0||||0.67|TWO_SIDED|95.0|0.63|1.59|||ANCOVA|||||1.59|0.63|0.670
72432456|NCT01928940|144377429|SUPERIORITY_OR_OTHER||Percentage|83.0|||<|0.0001|TWO_SIDED|95.0|35.9|99.6|||Exact binomial test||For Investigator Assessed ORR|||99.6|35.9|<0.0001
72432457|NCT01928940|144377429|SUPERIORITY_OR_OTHER||Percentage|83.0|||<|0.0001|TWO_SIDED|95.0|35.9|99.6|||Exact binomial test||BICR Assessed ORR|||99.6|35.9|<0.0001
72432458|NCT01928940|144377434|SUPERIORITY_OR_OTHER||Percentage|83.0|||<|0.0001|TWO_SIDED|95.0|35.9|99.6|||Exact binomial test||For Investigator Assessed ORR|||99.6|35.9|<0.0001
72432459|NCT01928940|144377434|SUPERIORITY_OR_OTHER||Percentage|50.0||||0.0158|TWO_SIDED|95.0|11.8|82.2|||Exact binomial test||BICR Assessed ORR|||82.2|11.8|0.0158
72432460|NCT01928940|144377435|SUPERIORITY_OR_OTHER||Percentage|83.0|||<|0.0001|TWO_SIDED|95.0|35.9|99.6|||Exact binomial test||For Investigator Assessed ORR|||99.6|35.9|<0.0001
72432461|NCT01928940|144377435|SUPERIORITY_OR_OTHER||Percentage|50.0||||0.0158|TWO_SIDED|95.0|11.8|88.2|||Exact binomial test||BICR Assessed ORR|||88.2|11.8|0.0158
72432462|NCT01928940|144377438|SUPERIORITY_OR_OTHER||Percentage|83.0|||<|0.0001|TWO_SIDED|95.0|35.9|99.6|||Exact binomial test||For Investigator Assessed ORR|||99.6|35.9|<0.0001
72432463|NCT01928940|144377438|SUPERIORITY_OR_OTHER||Percentage|83.0|||<|0.0001|TWO_SIDED|95.0|35.9|99.6|||Exact binomial test||BICR Assessed ORR|||99.6|35.9|<0.0001
72432464|NCT01363479|144377458|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The null hypothesis was rejected (and non inferiority of oral palonosetron 0.50 mg versus I.V. palonosetron 0.25 mg demonstrated), if the lower limit of the 2 sided 99% CI for the difference in proportion of patients with CR (risk difference) was greater (i.e., closer to zero) than 15%.Study had 90% power.|Risk Difference (RD)|3.21|||||TWO_SIDED|99.0|-2.74|9.17|||||The risk difference and the 99% CI calculation were performed using a 2 sided stratum adjusted Cochran Mantel Haenszel (CMH) test including gender and region as strata.|||9.17|-2.74|
72432465|NCT01119703|144377461|SUPERIORITY_OR_OTHER||Coefficient of Determination %|-9.1|||||TWO_SIDED|95.0|-13.8|-0.7|||||Crossvalidated; negative values mean that the fitted model performs worse than chance on the test set.|Null hypothesis for Predicted versus Measured Titers states that Coefficient of Determination % (CD%) \<= 20%; whereas the alternative hypothesis is \> 20%. CD% was obtained by fitting a random forest model to the measured titers, which included all baseline biomarkers as predictors.||-0.7|-13.8|
72432466|NCT01119703|144377462|SUPERIORITY_OR_OTHER||Coefficient of Determination %|17.6|||||TWO_SIDED|95.0|10.6|20.9|||||Crossvalidated; negative values mean that the fitted model performs worse than chance on the test set.|Null hypothesis for Predicted versus Measured Titers states that Coefficient of Determination % (CD%) \<= 20%; whereas the alternative hypothesis is \> 20%. CD% was obtained by fitting a random forest model to the measured titers, which included all baseline biomarkers as predictors.||20.9|10.6|
72432467|NCT01119703|144377463|SUPERIORITY_OR_OTHER||Coefficient of Determination %|27.8|||||TWO_SIDED|95.0|19.6|32.4|||||Crossvalidated; negative values mean that the fitted model performs worse than chance on the test set.|Null hypothesis for Predicted versus Measured Titers states that Coefficient of Determination % (CD%) \<= 20%; whereas the alternative hypothesis is \> 20%. CD% was obtained by fitting a random forest model to the measured titers, which included all baseline biomarkers as predictors.||32.4|19.6|
72493598|NCT00511355|144516389|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5668||95.0||||No correction for multiple testing was made.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for age class applied on the changes from baseline.||P-value compares the change from baseline to Cycle 6 between treatment groups.||||0.5668
72432468|NCT01119703|144377464|SUPERIORITY_OR_OTHER||Coefficient of Determination %|3.3||||||95.0|-2.8|8.5|||||Crossvalidated; negative values mean that the fitted model performs worse than chance on the test set.|Null hypothesis for Predicted versus Measured Titers states that Coefficient of Determination % (CD%) \<= 20%; whereas the alternative hypothesis is \> 20%. CD% was obtained by fitting a random forest model to the measured titers, which included all baseline biomarkers as predictors.||8.5|-2.8|
72432469|NCT01119703|144377465|SUPERIORITY_OR_OTHER||Spearman's Correlation Coefficient|-0.04||||0.66|TWO_SIDED|95.0|-0.2|0.13|||Fisher's Z-transformation||Within-participant rank correlation|Diphtheria versus Hepatitis B||0.13|-0.2|0.66
72432470|NCT01119703|144377465|SUPERIORITY_OR_OTHER||Spearman's Correlation Coefficient|0.1||||0.26|TWO_SIDED|95.0|-0.07|0.25|||Fisher's Z-transformation||Within-participant rank correlation|Diphtheria versus Cholera||0.25|-0.07|0.26
72432471|NCT01119703|144377465|SUPERIORITY_OR_OTHER||Spearman's Correlation Coefficient|0.4|||<|0.001|TWO_SIDED|95.0|0.26|0.53|||Fisher's Z-transformation||Within-participant rank correlation|Diphtheria versus Tetanus||0.53|0.26|<0.001
72432472|NCT01119703|144377465|SUPERIORITY_OR_OTHER||Spearman's Correlation Coefficient|-0.17||||0.04|TWO_SIDED|95.0|-0.32|-0.01|||Fisher's Z-transformation||Within-participant rank correlation|Hepatitis B versus Cholera||-0.01|-0.32|0.04
72432473|NCT01119703|144377465|SUPERIORITY_OR_OTHER||Spearman's Correlation Coefficient|-0.09||||0.3|TWO_SIDED|95.0|-0.25|0.08|||Fisher's Z-transformation||Within-participant rank correlation|Hepatitis B versus Tetanus||0.08|-0.25|0.30
72432474|NCT01119703|144377465|SUPERIORITY_OR_OTHER||Spearman's Correlation Coefficient|0.08||||0.36|TWO_SIDED|95.0|-0.09|0.24|||Fisher's Z-transformation||Within-participant rank correlation|Cholera versus Tetanus||0.24|-0.09|0.36
72432475|NCT01119703|144377466|SUPERIORITY_OR_OTHER||Coefficient of Determination %|-9.5|||||TWO_SIDED|95.0|-16.6|-2.7|||||Crossvalidated; negative values mean that the fitted model performs worse than chance on the test set.|Null hypothesis for Predicted versus Measured Titers states that Coefficient of Determination % (CD%) \<= 20%; whereas the alternative hypothesis is \> 20%. CD% was obtained by fitting a random forest model to the measured titers, which included all Day 7 biomarkers as predictors.||-2.7|-16.6|
72432476|NCT01119703|144377467|SUPERIORITY_OR_OTHER||Coefficient of Determination %|23.7|||||TWO_SIDED|95.0|14.0|29.7|||||Crossvalidated; negative values mean that the fitted model performs worse than chance on the test set.|Null hypothesis for Predicted versus Measured Titers states that Coefficient of Determination % (CD%) \<= 20%; whereas the alternative hypothesis is \> 20%. CD% was obtained by fitting a random forest model to the measured titers, which included all Day 7 biomarkers as predictors.||29.7|14.0|
72432477|NCT01119703|144377468|SUPERIORITY_OR_OTHER||Coefficient of Determination %|36.7|||||TWO_SIDED|95.0|28.7|41.5|||||Crossvalidated;negative values mean that the fitted model performs worse than chance on the test set.|Null hypothesis for Predicted versus Measured Titers states that Coefficient of Determination % (CD%) \<= 20%; whereas the alternative hypothesis is \> 20%. CD% was obtained by fitting a random forest model to the measured titers, which included all Day 7 biomarkers as predictors.||41.5|28.7|
72432478|NCT01119703|144377469|SUPERIORITY_OR_OTHER||Coefficient of Determination %|-2.2|||||TWO_SIDED|95.0|-7.8|4.4|||||Crossvalidated; negative values mean that the fitted model performs worse than chance on the test set.|Null hypothesis for Predicted versus Measured Titers states that Coefficient of Determination % (CD%) \<= 20%; whereas the alternative hypothesis is \> 20%. CD% was obtained by fitting a random forest model to the measured titers, which included all Day 7 biomarkers as predictors.||4.4|-7.8|
72432479|NCT01872611|144377485|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.9|STANDARD_ERROR_OF_MEAN|0.2||0.671|TWO_SIDED|95.0|0.7|1.3|||Regression, Logistic||Parameter dispersion is the standard error for the odds ratio.|This endpoint was considered primary for United States (US) registration and secondary for European Union (EU) registration.||1.3|0.7|0.671
72432480|NCT01872611|144377486|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.4|STANDARD_ERROR_OF_MEAN|0.1||0.001|TWO_SIDED|95.0|0.2|0.7|||Regression, Logistic||Parameter dispersion is the standard error for the odds ratio.|This endpoint was considered primary for EU registration and secondary for US registration.||0.7|0.2|0.001
72432481|NCT05096117|144377542|SUPERIORITY||Least Square Mean Difference|0.178||||0.784|TWO_SIDED||||||ANCOVA|||||||0.784
72432482|NCT01446003|144377560|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.02|||||TWO_SIDED|90.0|-0.52|4.56|||Linear mixed effect models|The model contained period and treatment as fixed effect, Day -1 baseline as a fixed continuous covariate, and participant as random effect.||If the upper limit of the 90% confidence interval lies below the bound 5 mmHg, the hypothesis that change from baseline in ambulatory 24-hour mean SBP in participants with mild to moderate hypertension following 10 days of multiple dosing of MK-8457 is similar to placebo will be supported.||4.56|-0.52|
72432483|NCT01446003|144377561|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|1.57|||||TWO_SIDED|90.0|0.19|2.96|||Linear mixed effects model|The model contained period and treatment as fixed effect, Day -1 baseline as a fixed continuous covariate, and participant as random effect.||||2.96|0.19|
72432484|NCT01446003|144377562|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.9|||||TWO_SIDED|90.0|2.44|13.35|||Linear mixed effects model|The model contained period and treatment as fixed effect, Day -1 baseline as a fixed continuous covariate, and participant as random effect.||Treatment comparison of maxMAΔ in SBP from baseline to Day 10 after AM dosing||13.35|2.44|
72432485|NCT01446003|144377562|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.94|||||TWO_SIDED|90.0|-5.68|3.81|||Linear mixed effects model|The model contained period and treatment as fixed effect, Day -1 baseline as a fixed continuous covariate, and participant as random effect.||Treatment comparison of maxMAΔ in SBP from baseline to Day 10 after PM dosing||3.81|-5.68|
72493599|NCT00511355|144516390|SUPERIORITY_OR_OTHER_LEGACY|||||||0.177||95.0||||No correction for multiple testing was made.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for age class applied on the changes from baseline.||P-value compares the change from baseline to Cycle 6 between treatment groups.||||0.1770
72493600|NCT00511355|144516391|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0||||No correction for multiple testing was made.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for age class applied on the changes from baseline.||P-value compares the change from baseline to Cycle 6 between treatment groups.||||<.0001
72493601|NCT00802685|144516409|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|4.0|STANDARD_DEVIATION|8.0||0.858|TWO_SIDED|95.0|4.0|36.0|||Wilcoxon (Mann-Whitney)|||Null hypothesis: Oxygen duration (days) during the first 28 days will be equal between treatment arms.||36|4|0.858
72432486|NCT01446003|144377562|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.26|||||TWO_SIDED|90.0|0.81|9.71|||Linear mixed effects model|The model contained period and treatment as fixed effect, Day -1 baseline as a fixed continuous covariate, and participant as random effect.||Treatment comparison of maxMAΔ in DBP from baseline to Day 10 after AM dosing||9.71|0.81|
72432487|NCT01446003|144377562|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.69|||||TWO_SIDED|90.0|-4.55|1.17|||Linear mixed effects model|The model contained period and treatment as fixed effect, Day -1 baseline as a fixed continuous covariate, and participant as random effect.||Treatment comparison of maxMAΔ in DBP from baseline to Day 10 after PM dosing||1.17|-4.55|
72432488|NCT00318656|144377569|SUPERIORITY_OR_OTHER||Mean Difference (Net)|5.02|STANDARD_ERROR_OF_MEAN|2.49||0.064||95.0|-0.32|10.36|||ANCOVA|Analysis of covariance (ANCOVA)|Mean Difference =(Rosiglitazone + Met) - (Glimepiride+Met)|Statistical analysis was based off of week 12 results.||10.36|-0.32|0.064
72432489|NCT00318656|144377570|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.26|STANDARD_ERROR_OF_MEAN|1.45||0.923||95.0|-3.37|2.85||P value von elteren (adjusted on sex)|ANCOVA||Mean Difference =(Rosiglitazone + Met) - (Glimepiride+Met)|Statistical analysis was based off of week 12 results.||2.85|-3.37|0.923
72432490|NCT02806895|144377600|SUPERIORITY|||||||0.0062|||||||ANOVA|||||||0.0062
72432491|NCT02806895|144377601|SUPERIORITY|||||||0.0432|||||||ANOVA|||||||0.0432
72432492|NCT02806895|144377602|SUPERIORITY|||||||0.0414|||||||McNemar|||||||0.0414
72432493|NCT02806895|144377603|SUPERIORITY|||||||0.0963|||||||McNemar|||||||0.0963
72432494|NCT02806895|144377604|SUPERIORITY|||||||0.1435|||||||McNemar|||||||0.1435
72372779|NCT00966875|144256321|SUPERIORITY_OR_OTHER||||||<|0.001||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||<0.001
72432495|NCT02806895|144377605|SUPERIORITY|||||||0.1796|||||||McNemar|||||||0.1796
72432496|NCT02806895|144377606|SUPERIORITY|||||||0.1094|||||||McNemar|||||||0.1094
72432497|NCT02806895|144377607|SUPERIORITY|||||||0.4531|||||||McNemar|||||||0.4531
72432498|NCT02806895|144377608|SUPERIORITY|||||||0.3593|||||||McNemar|||||||0.3593
72432499|NCT02806895|144377609|SUPERIORITY|||||||0.6072|||||||McNemar|||||||0.6072
72372780|NCT00966875|144256321|SUPERIORITY_OR_OTHER||||||<|0.001||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||<0.001
72372781|NCT00966875|144256321|SUPERIORITY_OR_OTHER||||||<|0.001||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||<0.001
72372782|NCT00966875|144256321|SUPERIORITY_OR_OTHER|||||||0.001||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||0.001
72372783|NCT00966875|144256323|SUPERIORITY_OR_OTHER|||||||0.013|TWO_SIDED|||||P-value is for Week 12 LOCF.|Fisher Exact|||||||0.013
72432500|NCT02806895|144377610|SUPERIORITY|||||||0.7905|||||||McNemar|||||||0.7905
72432501|NCT02806895|144377611|SUPERIORITY|||||||1|||||||McNemar|||||||1.0000
72432502|NCT02806895|144377612|SUPERIORITY|||||||1|||||||McNemar|||||||1.0000
72432503|NCT02806895|144377613|SUPERIORITY|||||||1|||||||McNemar|||||||1.0000
72432504|NCT02806895|144377614|SUPERIORITY|||||||0.4116|||||||ANOVA|||||||0.4116
72432505|NCT02806895|144377615|SUPERIORITY|||||||0.1991|||||||ANOVA|||||||0.1991
72432506|NCT02806895|144377616|SUPERIORITY|||||||0.0806|||||||ANOVA|||||||0.0806
72432507|NCT02806895|144377617|SUPERIORITY|||||||0.9391|||||||ANOVA|||||||0.9391
72432508|NCT02806895|144377618|SUPERIORITY|||||||0.2116|||||||ANOVA|||||||0.2116
72432509|NCT02806895|144377619|SUPERIORITY|||||||0.1604|||||||ANOVA|||||||0.1604
72432510|NCT02806895|144377620|SUPERIORITY|||||||0.2144|||||||ANOVA|||||||0.2144
72432511|NCT02806895|144377621|SUPERIORITY|||||||0.0387|||||||ANOVA|||||||0.0387
72432512|NCT02806895|144377622|SUPERIORITY|||||||0.3426|||||||ANOVA|||||||0.3426
72432513|NCT02806895|144377623|SUPERIORITY|||||||0.1531|||||||ANOVA|||||||0.1531
72432514|NCT02806895|144377624|SUPERIORITY|||||||0.5603|||||||ANOVA|||||||0.5603
72432515|NCT02806895|144377625|SUPERIORITY|||||||0.4851|||||||ANOVA|||||||0.4851
72432516|NCT02806895|144377626|SUPERIORITY|||||||0.0241|||||||ANOVA|||||||0.0241
72432517|NCT02042443|144377627|SUPERIORITY||Hazard Ratio (HR)|2.02||||0.05|TWO_SIDED|95.0|1.01|4.03|||Log Rank|||||4.03|1.01|0.05
72432518|NCT02735187|144377631|SUPERIORITY|A paired t-test was applied to test the primary hypothesis. In case the requirements for normality were not met, a non-parametric analysis (Wilcoxon signed rank test) was performed.||||||0.6469||||||A probability (P-Value) above 0.05 is considered not to be statistical significant.|t-test, 2 sided|||||||0.6469
72432519|NCT05750745|144377687|SUPERIORITY||Adjusted Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.096||0.0871|TWO_SIDED|95.0|-0.36|0.02|||Mixed Model with Repeated Measure (MMRM)||Adjusted mean difference was calculated as test minus negative control.|||0.02|-0.36|0.0871
72432520|NCT05750745|144377688|SUPERIORITY||Adjusted Mean Difference|6.21|STANDARD_ERROR_OF_MEAN|3.548||0.0972|TWO_SIDED|95.0|-0.78|13.2|||van Elteren Test|P-value was from the van Elteren test adjusted for Baseline Schiff sensitivity stratification factor.|Adjusted mean difference was calculated as test minus negative control.|||13.20|-0.78|0.0972
72432521|NCT05750745|144377689|SUPERIORITY||Adjusted Mean Difference|-5.81|STANDARD_ERROR_OF_MEAN|3.16||0.0671|TWO_SIDED|95.0|-12.04|0.41|||MMRM||Adjusted mean difference was calculated as test minus negative control.|||0.41|-12.04|0.0671
72432522|NCT05750745|144377690|SUPERIORITY||Adjusted Mean Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.07||0.0673|TWO_SIDED|95.0|-0.27|0.01|||MMRM||Adjusted mean difference was calculated as test minus negative control.|||0.01|-0.27|0.0673
72432523|NCT05750745|144377691|SUPERIORITY||Adjusted Mean Difference|2.38|STANDARD_ERROR_OF_MEAN|2.446||0.405|TWO_SIDED|95.0|-2.44|7.2|||van Elteren Test|P-value was from the van Elteren test adjusted for Baseline Schiff sensitivity stratification factor.|Adjusted mean difference was calculated as test minus negative control.|||7.20|-2.44|0.4050
72372784|NCT00966875|144256323|SUPERIORITY_OR_OTHER|||||||0.076|TWO_SIDED|||||P-value is for Week 12 LOCF.|Fisher Exact|||||||0.076
72432524|NCT05750745|144377692|SUPERIORITY||Adjusted Mean Difference|-5.64|STANDARD_ERROR_OF_MEAN|2.656||0.0346|TWO_SIDED|95.0|-10.88|-0.41|||MMRM||Adjusted mean difference was calculated as test minus negative control.|||-0.41|-10.88|0.0346
72432525|NCT05750745|144377693|SUPERIORITY||Adjusted Mean Difference|0.02|STANDARD_ERROR_OF_MEAN|0.085||0.8256|TWO_SIDED|95.0|-0.15|0.19|||MMRM||Adjusted mean difference was calculated as positive control minus negative control.|Change from Baseline at Week 6||0.19|-0.15|0.8256
72618292|NCT00286455|144767658|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.216||||0.23|TWO_SIDED|95.0|-0.568|0.137||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.137|-0.568|0.230
72372785|NCT00966875|144256323|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED|||||P-value is for Week 12 LOCF.|Fisher Exact|||||||0.002
72372786|NCT00966875|144256323|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||P-value is for Week 12 LOCF.|Fisher Exact|||||||<0.001
72372787|NCT00966875|144256323|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED|||||P-value is for Week 12.|Fisher Exact|||||||0.002
72372788|NCT00966875|144256323|SUPERIORITY_OR_OTHER|||||||0.006|TWO_SIDED|||||P-value is for Week 12 LOCF.|Fisher Exact|||||||0.006
72372789|NCT00966875|144256323|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED|||||P-value is for Week 12.|Fisher Exact|||||||0.001
72372790|NCT00966875|144256325|SUPERIORITY_OR_OTHER|||||||0.307||||||P-value is for Week 12.|ANCOVA|||||||0.307
72372791|NCT00966875|144256325|SUPERIORITY_OR_OTHER|||||||0.104||||||P-value is for Week 12.|ANCOVA|||||||0.104
72372792|NCT00966875|144256325|SUPERIORITY_OR_OTHER|||||||0.139||||||P-value is for Week 12.|ANCOVA|||||||0.139
72372793|NCT00966875|144256325|SUPERIORITY_OR_OTHER|||||||0.056||||||P-value is for Week 12.|ANCOVA|||||||0.056
72372794|NCT00966875|144256325|SUPERIORITY_OR_OTHER|||||||0.048|TWO_SIDED|||||P-value is for Week 12.|ANCOVA|||||||0.048
72372795|NCT00966875|144256325|SUPERIORITY_OR_OTHER|||||||0.16||||||P-value is for Week 12.|ANCOVA|||||||0.160
72372796|NCT00966875|144256325|SUPERIORITY_OR_OTHER|||||||0.029||||||P-value is for Week 12.|ANCOVA|||||||0.029
72372797|NCT00966875|144256327|SUPERIORITY_OR_OTHER|||||||0.272||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||0.272
72372798|NCT00966875|144256327|SUPERIORITY_OR_OTHER|||||||0.962||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||0.962
72372799|NCT00966875|144256327|SUPERIORITY_OR_OTHER|||||||0.236||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||0.236
72372800|NCT00966875|144256327|SUPERIORITY_OR_OTHER|||||||0.316||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||0.316
72372801|NCT00966875|144256327|SUPERIORITY_OR_OTHER|||||||0.138||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||0.138
72372802|NCT00966875|144256327|SUPERIORITY_OR_OTHER|||||||0.975||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||0.975
72372803|NCT00966875|144256327|SUPERIORITY_OR_OTHER|||||||0.079|TWO_SIDED|||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||0.079
72372804|NCT00966875|144256329|SUPERIORITY_OR_OTHER|||||||0.982||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||0.982
72372805|NCT00966875|144256329|SUPERIORITY_OR_OTHER|||||||0.276||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||0.276
72372806|NCT00966875|144256329|SUPERIORITY_OR_OTHER|||||||0.05||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||0.050
72372807|NCT00966875|144256329|SUPERIORITY_OR_OTHER|||||||0.01||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||0.010
72372808|NCT00966875|144256329|SUPERIORITY_OR_OTHER|||||||0.046||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||0.046
72372809|NCT00966875|144256329|SUPERIORITY_OR_OTHER|||||||0.017||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||0.017
72372810|NCT00966875|144256329|SUPERIORITY_OR_OTHER|||||||0.066||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||0.066
72372811|NCT00966875|144256331|SUPERIORITY_OR_OTHER|||||||0.538||||||P-value is for Week 12.|Fisher Exact|||||||0.538
72372812|NCT00966875|144256331|SUPERIORITY_OR_OTHER|||||||0.515||||||P-value is for Week 12.|Fisher Exact|||||||0.515
72372813|NCT00966875|144256331|SUPERIORITY_OR_OTHER|||||||0.03||||||P-value is for Week 12.|Fisher Exact|||||||0.030
72372814|NCT00966875|144256331|SUPERIORITY_OR_OTHER|||||||0.053||||||P-value is for Week 12.|Fisher Exact|||||||0.053
72372815|NCT00966875|144256331|SUPERIORITY_OR_OTHER|||||||0.393||||||P-value is for Week 12.|Fisher Exact|||||||0.393
72372816|NCT00966875|144256331|SUPERIORITY_OR_OTHER|||||||0.077||||||P-value is for Week 12.|Fisher Exact|||||||0.077
72372817|NCT00966875|144256331|SUPERIORITY_OR_OTHER|||||||0.105||||||P-value is for Week 12.|Fisher Exact|||||||0.105
72372818|NCT04657666|144256339|SUPERIORITY||Combined least mean square difference|0.04|STANDARD_ERROR_OF_MEAN|0.1||0.7152|TWO_SIDED|95.0|-0.16|0.23||Based on a combination of 300 linear mixed models for crossover data on the response variable change from baseline in LLMT-6 with period level LLMT-6 baseline covariate, treatment group, period, and sequence as fixed effects.|Mixed Models Analysis|Pattern mixture model (PMM) control-based imputation, mixed model repeated measures (MMRM)||||0.23|-0.16|0.7152
72372819|NCT02386189|144256359|SUPERIORITY||Mean Difference (Net)|-4.65|STANDARD_DEVIATION|7.3||0.02|TWO_SIDED||||||t-test, 2 sided|||The t-test was conducted on change between baseline and 12-month follow-up.||||0.02
72372820|NCT02386189|144256360|SUPERIORITY||Mean Difference (Net)|2.91|STANDARD_DEVIATION|5.5||0.06|TWO_SIDED||||||t-test, 2 sided|||||||0.06
72372821|NCT02386189|144256361|SUPERIORITY||Mean Difference (Net)|0.28|STANDARD_DEVIATION|2.7||0.71|TWO_SIDED||||||t-test, 2 sided|||||||0.71
72372822|NCT02386189|144256362|SUPERIORITY|||||||0.17|||||||Fisher Exact|||||||0.17
72372823|NCT02386189|144256363|SUPERIORITY||Mean Difference (Net)|-0.01|STANDARD_DEVIATION|0.15||0.75|TWO_SIDED||||||t-test, 2 sided|||||||0.75
72372824|NCT02386189|144256364|SUPERIORITY||Mean Difference (Final Values)|-3.6|STANDARD_DEVIATION|7.1||0.18|TWO_SIDED||||||t-test, 2 sided|||||||0.18
72372825|NCT02386189|144256365|SUPERIORITY||Mean Difference (Final Values)|-0.5|STANDARD_DEVIATION|8.9||0.89|TWO_SIDED||||||t-test, 2 sided|||||||0.89
72372826|NCT02937584|144256416|OTHER||Geometric mean ratio to baseline|1.11||||0.0187|TWO_SIDED|95.0|1.02|1.22||Statistical significance assessed using Hochberg's procedure applied across primary endpoints within each treatment|t-test, 2 sided|Within-group comparison to baseline using paired test||||1.22|1.02|0.0187
72432526|NCT05750745|144377693|SUPERIORITY||Adjusted Mean Difference|0.07|STANDARD_ERROR_OF_MEAN|0.117||0.5314|TWO_SIDED|95.0|-0.16|0.3|||MMRM||Adjusted mean difference was calculated as positive control minus negative control.|Change from Baseline at Week 12||0.30|-0.16|0.5314
72432527|NCT05750745|144377694|SUPERIORITY||Adjusted Mean Difference|-2.59|STANDARD_ERROR_OF_MEAN|2.99||0.5575|TWO_SIDED|95.0|-8.48|3.3|||van Elteren Test|P-value was from the Van Elteren test adjusted for Baseline Schiff sensitivity stratification factor.|Adjusted mean difference was calculated as positive control minus negative control.|Change from Baseline at Week 6||3.30|-8.48|0.5575
72432528|NCT05750745|144377694|SUPERIORITY||Adjusted Mean Difference|-1.12|STANDARD_ERROR_OF_MEAN|4.308||0.7717|TWO_SIDED|95.0|-9.6|7.37|||van Elteren Test|P-value was from the van Elteren test adjusted for Baseline Schiff sensitivity stratification factor.|Adjusted mean difference was calculated as positive control minus negative control.|Change from Baseline at Week 12||7.37|-9.60|0.7717
72432529|NCT05750745|144377695|SUPERIORITY||Adjusted Mean Difference|0.75|STANDARD_ERROR_OF_MEAN|3.235||0.818|TWO_SIDED|95.0|-5.63|7.12|||MMRM||Adjusted mean difference was calculated as positive control minus negative control.|Change from Baseline at Week 6||7.12|-5.63|0.8180
72432530|NCT05750745|144377695|SUPERIORITY||Adjusted Mean Difference|3.73|STANDARD_ERROR_OF_MEAN|3.834||0.3322|TWO_SIDED|95.0|-3.83|11.28|||MMRM||Adjusted mean difference was calculated as positive control minus negative control.|Change from Baseline at Week 12||11.28|-3.83|0.3322
72432531|NCT00783692|144377699|SUPERIORITY_OR_OTHER||Risk Difference (RD)|7.8||||0.0206|TWO_SIDED|95.0|1.2|14.3||P-value is based on the Cochran-Mantel-Haenszel (CMH) chi-square test, with stratification according to: 1) concomitant use of oral corticosteroids (yes/no); 2) previous exposure to TNFα antagonists and/or concomitant immunomodulator use (yes/no).|Cochran-Mantel-Haenszel||Risk Difference = adjusted (for stratification factors) percent vedolizumab - adjusted percent placebo|The Hochberg method was applied to control the overall Type I error rate at a 5% significance level for the multiple comparisons of the primary endpoints. If both p-values were ≤ 0.05, both primary endpoints were to be declared significant. If 1 of the p-values for the primary endpoints was \> 0.05, the other p-value was to be tested at the 0.025 level and declared significant only if the p-value was ≤ 0.025. If neither primary was declared significant, no further testing was to be conducted.||14.3|1.2|0.0206
72432532|NCT00783692|144377700|SUPERIORITY_OR_OTHER||Risk Difference (RD)|5.7||||0.2322|TWO_SIDED|95.0|-3.6|15.0||P-value is based on the Cochran-Mantel-Haenszel (CMH) chi-square test, with stratification according to: 1) concomitant use of oral corticosteroids (yes/no); 2) previous exposure to TNFα antagonists and/or concomitant immunomodulator use (yes/no).|Cochran-Mantel-Haenszel||Risk Difference = adjusted (for stratification factors) percent vedolizumab - adjusted percent placebo|The Hochberg method was applied to control the overall Type I error rate at a 5% significance level for the multiple comparisons of the primary endpoints. If both p-values were ≤ 0.05, both primary endpoints were to be declared significant. If 1 of the p-values for the primary endpoints was \> 0.05, the other p-value was to be tested at the 0.025 level and declared significant only if the p-value was ≤ 0.025. If neither primary was declared significant, no further testing was to be conducted.||15.0|-3.6|0.2322
72432533|NCT00783692|144377701|SUPERIORITY_OR_OTHER||Risk Difference (RD)|17.4||||0.0007|TWO_SIDED|95.0|7.3|27.5||CMH chi-square test, stratified by: 1) concomitant use of oral corticosteroids (yes/no); 2) previous exposure to TNFα antagonists and/or concomitant immunomodulator use (yes/no); 3) enrollment in Cohort 1 or Cohort 2 in the Induction Phase.|Cochran-Mantel-Haenszel||Risk Difference = adjusted (for stratification factors) percent vedolizumab - adjusted percent placebo|The Hochberg method was applied to control the overall Type I error rate at a 5% significance level. If both p-values were ≤ 0.05, both dose regimens were to be declared significant. If 1 of the p-values for the 2 dose comparisons was \> 0.05, the other p-value was to be tested at the 0.025 level and declared significant only if the p-value was ≤ 0.025. If neither dose was declared significant for the primary endpoint, no further testing was to be conducted.||27.5|7.3|0.0007
72493602|NCT00802685|144516410|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.953||||0.8|TWO_SIDED|95.0|0.393|2.309|||Cochran-Mantel-Haenszel|||null hypothesis: The proportion of subjects on O2 at 36 wk PMA will be equal between treatment arms.||2.309|0.393|0.8
72493603|NCT03208231|144516416|SUPERIORITY|||||||0.79|||||||Fisher Exact|||||||0.79
72493604|NCT03208231|144516417|SUPERIORITY|||||||0.42|||||||Wilcoxon (Mann-Whitney)|||||||0.42
72493605|NCT00644787|144516446|NON_INFERIORITY_OR_EQUIVALENCE|Difference of 7.5 mm in VAS score was selected as the threshold value for clinical non-inferiority of Fentanyl 1-day transdermal patch to Fentanyl 3-day transdermal patch.|Mean Difference (Final Values)|1.4|||||TWO_SIDED|95.0|-3.5|6.23||||||||6.23|-3.50|
72555252|NCT00318461|144642194|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg + metformin and glimepiride + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|-0.38||||0.1845||95.0|-0.87|0.11|||ANCOVA|||Change in fasting plasma glucose from baseline to end of treatment at 26 weeks was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline fasting plasma glucose as covariate.||0.11|-0.87|0.1845
72555253|NCT00318461|144642194|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.2 mg + metformin and placebo + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|-2.04|||<|0.0001||95.0|-2.63|-1.44|||ANCOVA|||Change in fasting plasma glucose from baseline to end of treatment at 26 weeks was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline fasting plasma glucose as covariate.||-1.44|-2.63|<0.0001
72555254|NCT00318461|144642194|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.2 mg + metformin and glimepirde + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|-0.33||||0.3047||95.0|-0.82|0.17|||ANCOVA|||Change in fasting plasma glucose from baseline to end of treatment at 26 weeks was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline fasting plasma glucose t as covariate.||0.17|-0.82|0.3047
72493606|NCT03048422|144516461|NON_INFERIORITY|Equivalence margin was a 10% difference between groups.|Risk Difference (RD)|6.5|||||TWO_SIDED|95.0|2.0|10.7||||||Difference in proportions for intention-to-treat analysis.||10.7|2.0|
72493607|NCT03048422|144516461|NON_INFERIORITY|Equivalence margin was a 10% difference between groups.|Risk Difference (RD)|6.0|||||TWO_SIDED|95.0|1.6|10.3||||||Difference in proportions for per-protocol analysis.||10.3|1.6|
72493608|NCT03048422|144516461|SUPERIORITY||Risk Difference (RD)|6.5||||0.005|TWO_SIDED|95.0|2.0|10.7|||Wald test of two proportions|||Difference in proportions for superiority and intention-to-treat analysis.||10.7|2.0|0.005
72493609|NCT03048422|144516462|SUPERIORITY||Risk Difference (RD)|-8.8||||0.043|TWO_SIDED|95.0|-17.3|-0.3|||Wald test of two proportions|||Null hypothesis of no difference between groups (DTG+FTC/TAF - DTG+FTC/TDF).||-0.3|-17.3|0.043
72493610|NCT03048422|144516462|SUPERIORITY||Risk Difference (RD)|0.2||||0.97|TWO_SIDED|95.0|-8.8|9.1|||Wald test of two proportions|||Null hypothesis of no difference between groups (DTG+FTC/TDF - EFV/FTC/TDF).||9.1|-8.8|0.97
72493611|NCT03048422|144516462|SUPERIORITY||Risk Difference (RD)|-8.6||||0.047|TWO_SIDED|95.0|-17.1|-0.1|||Wald test of two proportions|||Null hypothesis of no difference between groups (DTG+FTC/TAF - EFV/FTC/TDF).||-0.1|-17.1|0.047
72493612|NCT03048422|144516463|SUPERIORITY||Risk Difference (RD)|-5.6||||0.098|TWO_SIDED|95.0|-14.2|2.9|||Z-test|||The Kaplan-Meier method was used to estimate survival probabilities. Survival probabilities were compared based on a Z-test using Greenwoods estimate of the standard error. The null hypothesis was no difference between arms (DTG+FTC/TAF - DTG+FTC/TDF).||2.9|-14.2|0.098
72493613|NCT03048422|144516463|SUPERIORITY||Risk Difference (RD)|2.6||||0.26|TWO_SIDED|95.0|-5.9|11.7|||Z-test|||The Kaplan-Meier method was used to estimate survival probabilities. Survival probabilities were compared based on a Z-test using Greenwoods estimate of the standard error. The null hypothesis was no difference between arms (DTG+FTC/TDF-EFV/FTC/TDF).||11.7|-5.9|0.26
72493614|NCT03048422|144516463|SUPERIORITY||Risk Difference (RD)|-2.8||||0.26|TWO_SIDED|95.0|-11.3|5.8|||Z-test|||The Kaplan-Meier method was used to estimate survival probabilities. Survival probabilities were compared based on a Z-test using Greenwoods estimate of the standard error. The null hypothesis was no difference between arms (DTG+FTC/TAF-EFV/FTC/TDF).||5.8|-11.3|0.26
72493615|NCT03048422|144516464|SUPERIORITY||Risk Difference (RD)|-3.2||||0.25|TWO_SIDED|95.0|-12.8|6.3|||Z-test|||The Kaplan-Meier method was used to estimate survival probabilities. Comparisons of survival probabilities was based on a Z-test using Greenwoods estimate of the standard error. The null hypothesis was no difference between arms, with estimated difference of DTG+FTC/TAF - DTG+FTC/TDF.||6.3|-12.8|0.25
72493616|NCT03048422|144516464|SUPERIORITY||Risk Difference (RD)|-2.3||||0.32|TWO_SIDED|95.0|-12.1|7.5|||Z-test|||The Kaplan-Meier method was used to estimate survival probabilities. Comparisons of survival probabilities was based on a Z-test using Greenwoods estimate of the standard error. The null hypothesis was no difference between arms, with estimate of risk difference DTG+FTC/TDF-EFV/FTC/TDF.||7.5|-12.1|0.32
72493617|NCT03048422|144516464|SUPERIORITY||Risk Difference (RD)|-5.5||||0.11|TWO_SIDED|95.0|-14.3|3.2|||Z-test|||The Kaplan-Meier method was used to estimate survival probabilities. Comparisons of survival probabilities was based on a Z-test using Greenwoods estimate of the standard error. The null hypothesis was no difference between arms, with estimate of risk difference DTG+FTC/TAF-EFV/FTC/TDF.||3.2|-14.3|0.11
72493618|NCT03048422|144516465|SUPERIORITY||Risk Difference (RD)|15.6|||<|0.0001|TWO_SIDED|95.0|9.3|22.0|||Wald test of two proportions|||Difference in proportions between arms for intention-to-treat analysis with null hypothesis of no difference (DTG groups - EFV/FTC/TDF).||22.0|9.3|< 0.0001
72493619|NCT03048422|144516466|SUPERIORITY||Risk Difference (RD)|-0.1||||0.97|TWO_SIDED|95.0|-3.3|3.2|||Wald test of two proportions|||Difference in proportions for intention-to-treat analysis with null hypothesis of no difference between arms (DTG arms - EFV/FTC/TDF).||3.2|-3.3|0.97
72493620|NCT03048422|144516467|SUPERIORITY||Hazard Ratio (HR)|2.4|||<|0.001|TWO_SIDED|95.0|1.9|3.1|||Kaplan-Meier|||||3.1|1.9|< 0.001
72493621|NCT03048422|144516468|SUPERIORITY||Risk Difference (RD)|3.6||||0.19|TWO_SIDED|95.0|-1.8|9.1|||Wald test of two proportions|||Difference between arms with null hypothesis of no difference (DTG+FTC/TAF - DTG+FTC/TDF).||9.1|-1.8|0.19
72493622|NCT03048422|144516468|SUPERIORITY||Risk Difference (RD)|-11.5|||<|0.001|TWO_SIDED|95.0|-17.9|-5.2|||Wald test of two proportions|||Difference between arms with null hypothesis of no difference (DTG+FTC/TDF - EFV/FTC/TDF).||-5.2|-17.9|< 0.001
72493623|NCT03048422|144516468|SUPERIORITY||Risk Difference (RD)|-7.9||||0.022|TWO_SIDED|95.0|-14.6|-1.2|||Wald test of two proportions|||Difference between arms with null hypothesis of no difference (DTG+FTC/TAF - EFV/FTC/TDF).||-1.2|-14.6|0.022
72493624|NCT03048422|144516469|SUPERIORITY||Risk Difference (RD)|2.1||||0.61|TWO_SIDED|95.0|-5.9|10.1|||Wald test of two proportions|||Difference between arms with null hypothesis of no difference (DTG+FTC/TAF - DTG+FTC/TDF).||10.1|-5.9|0.61
72493625|NCT03048422|144516469|SUPERIORITY||Risk Difference (RD)|-1.4||||0.74|TWO_SIDED|95.0|-9.4|6.6|||Wald test of two proportions|||Difference between arms with null hypothesis of no difference (DTG+FTC/TDF - EFV/FTC/TDF).||6.6|-9.4|0.74
72493626|NCT03048422|144516469|SUPERIORITY||Risk Difference (RD)|0.7||||0.86|TWO_SIDED|95.0|-7.4|8.8|||Wald test of two proportions|||Difference between arms with null hypothesis of no difference (DTG+FTC/TAF - EFV/FTC/TDF).||8.8|-7.4|0.86
72493627|NCT03048422|144516470|SUPERIORITY||Risk Difference (RD)|4.3||||0.27|TWO_SIDED|95.0|-3.4|11.9|||Wald test of two proportions|||Null hypothesis of no difference between groups (DTG groups - EFV/FTC/TDF).||11.9|-3.4|0.27
72493628|NCT03048422|144516471|SUPERIORITY||Risk Difference (RD)|-0.1||||0.49|TWO_SIDED|95.0|-7.6|7.5|||Z-test|||The Kaplan-Meier method was used to estimate survival probabilities. Comparisons of survival probabilities was based on a Z-test using Greenwoods estimate of the standard error. The null hypothesis was no difference between arms, with estimate of risk difference combined DTG arms-EFV/FTC/TDF.||7.5|-7.6|0.49
72493629|NCT03048422|144516472|SUPERIORITY||Risk Difference (RD)|4.1||||0.15|TWO_SIDED|95.0|-3.8|12.0|||Z-test|||The Kaplan-Meier method was used to estimate survival probabilities. Comparisons of survival probabilities was based on a Z-test using Greenwoods estimate of the standard error. The null hypothesis was no difference between arms, with estimated difference of combined DTG arms - EFV/FTC/TDF.||12.0|-3.8|0.15
72493630|NCT03048422|144516473|SUPERIORITY||Risk Difference (RD)|-8.8||||0.043|TWO_SIDED|95.0|-17.3|-0.3|||Wald test of two proportions|||Null hypothesis of no difference between groups (DTG+FTC/TAF - DTG+FTC/TDF).||-0.3|-17.3|0.043
72372827|NCT02937584|144256416|OTHER||Geometric mean ratio to baseline|1.23|||<|0.0001|TWO_SIDED|95.0|1.14|1.33||Statistical significance assessed using Hochberg's procedure applied across primary endpoints within each treatment|t-test, 2 sided|Within-group comparison to baseline using paired test||||1.33|1.14|<0.0001
72372828|NCT02937584|144256417|OTHER||Geometric mean ratio to baseline|0.75||||0.0219|TWO_SIDED|95.0|0.59|0.95||Statistical significance assessed using Hochberg's procedure applied across primary endpoints within each treatment|t-test, 2 sided|Within-group comparison to baseline using paired test||||0.95|0.59|0.0219
72372829|NCT02937584|144256417|OTHER||Geometric mean ratio to baseline|0.56|||<|0.0001|TWO_SIDED|95.0|0.44|0.71||Statistical significance assessed using Hochberg's procedure applied across primary endpoints within each treatment|t-test, 2 sided|Within-group comparison to baseline using paired test||||0.71|0.44|<0.0001
72372830|NCT02937584|144256418|OTHER||Geometric mean ratio to baseline|1.12||||0.0283|TWO_SIDED|95.0|1.01|1.24|||t-test, 2 sided|Within-group comparison to baseline using paired test||||1.24|1.01|0.0283
72372831|NCT02937584|144256418|OTHER||Geometric mean ratio to baseline|1.21|||<|0.0001|TWO_SIDED|95.0|1.12|1.31|||t-test, 2 sided|Within-group comparison to baseline using paired test||||1.31|1.12|<0.0001
72372832|NCT02937584|144256419|OTHER||Geometric mean ratio to baseline|0.76||||0.0304|TWO_SIDED|95.0|0.59|0.97|||t-test, 2 sided|Within-group comparison to baseline using paired test||||0.97|0.59|0.0304
72372833|NCT02937584|144256419|OTHER||Geometric mean ratio to baseline|0.55||||0.0003|TWO_SIDED|95.0|0.41|0.72|||t-test, 2 sided|Within-group comparison to baseline using paired test||||0.72|0.41|0.0003
72372834|NCT02937584|144256420|OTHER||Mean Change from Baseline|0.065||||0.1582|TWO_SIDED|95.0|-0.028|0.158|||t-test, 2 sided|Within-group comparison to baseline using paired test||||0.158|-0.028|0.1582
72372835|NCT02937584|144256420|OTHER||Mean Change from Baseline|0.151||||0.0375|TWO_SIDED|95.0|0.01|0.292|||t-test, 2 sided|Within-group comparison to baseline using paired test||||0.292|0.010|0.0375
72372836|NCT02937584|144256421|OTHER||Geometric mean ratio to baseline|0.978||||0.6176|TWO_SIDED|95.0|0.891|1.073|||t-test, 2 sided|Within-group comparison to baseline using paired test||||1.073|0.891|0.6176
72372837|NCT02937584|144256421|OTHER||Geometric mean ratio to baseline|0.938||||0.2699|TWO_SIDED|95.0|0.833|1.056|||t-test, 2 sided|Within-group comparison to baseline using paired test||||1.056|0.833|0.2699
72372838|NCT00635219|144256422|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.7|STANDARD_ERROR_OF_MEAN|1.13||0.1321|TWO_SIDED|95.0|-3.92|0.51||Since p-value \>0.025, hierarchically testing stopped here.|ANCOVA||To adjust for multiplicity the two doses of vortioxetine were tested separately versus placebo in the primary and key secondary efficacy analyses at a Bonferroni-corrected significance level of 0.025.|As soon as an endpoint was non-significant at the 0.025 level of significance, the testing procedure was stopped for all subsequent endpoints.||0.51|-3.92|0.1321
72372839|NCT00635219|144256422|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.5|STANDARD_ERROR_OF_MEAN|1.13||0.1847|TWO_SIDED|95.0|-3.73|0.72||Since p-value \>0.025, hierarchically testing stopped here.|ANCOVA||To adjust for multiplicity the two doses of vortioxetine were tested separately versus placebo in the primary and key secondary efficacy analyses at a Bonferroni-corrected significance level of 0.025.|As soon as an endpoint was non-significant at the 0.025 level of significance, the testing procedure was stopped for all subsequent endpoints.||0.72|-3.73|0.1847
72372840|NCT00635219|144256422|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.38|STANDARD_ERROR_OF_MEAN|1.12||0.2187|TWO_SIDED|95.0|-3.59|0.82||This dose was not in the testing sequence. A nominal p-value is provided.|ANCOVA|||||0.82|-3.59|0.2187
72372841|NCT00635219|144256422|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.04|STANDARD_ERROR_OF_MEAN|1.14||0.0741|TWO_SIDED|95.0|-4.27|0.2||This treatment arm was not in the testing sequence. A nominal p-value is provided.|ANCOVA|||||0.20|-4.27|0.0741
72372842|NCT00635219|144256423|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.79|STANDARD_ERROR_OF_MEAN|1.13||0.112|TWO_SIDED|95.0|-4.01|0.42||A nominal p-value is provided.|ANCOVA||No correction for multiplicity was made.|||0.42|-4.01|0.1120
72372843|NCT00635219|144256423|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.63|STANDARD_ERROR_OF_MEAN|1.13||0.1487|TWO_SIDED|95.0|-3.85|0.59||A nominal p-value is provided.|ANCOVA||No correction for multiplicity was made.|||0.59|-3.85|0.1487
72372844|NCT00635219|144256423|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.11|STANDARD_ERROR_OF_MEAN|1.12||0.3246|TWO_SIDED|95.0|-3.31|1.1||A nominal p-value is provided.|ANCOVA||No correction for multiplicity was made.|||1.10|-3.31|0.3246
72372845|NCT00635219|144256423|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.47|STANDARD_ERROR_OF_MEAN|1.13||0.0298|TWO_SIDED|95.0|-4.7|-0.24||A nominal p-value is provided.|ANCOVA||No correction for multiplicity was made.|||-0.24|-4.70|0.0298
72372846|NCT00635219|144256424|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.41||||0.137|TWO_SIDED|95.0|0.9|2.23||A nominal p-value is provided.|Adjusting for Baseline||No correction for multiplicity was made.|||2.23|0.90|0.1370
72372847|NCT00635219|144256424|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.54||||0.0664|TWO_SIDED|95.0|0.97|2.43||A nominal p-value is provided.|Adjusting for Baseline||No correction for multiplicity was made.|||2.43|0.97|0.0664
72372848|NCT00635219|144256424|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.34||||0.2023|TWO_SIDED|95.0|0.85|2.12||A nominal p-value is provided.|Adjusting for Baseline||No correction for multiplicity was made.|||2.12|0.85|0.2023
72372849|NCT00635219|144256424|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.52||||0.0765|TWO_SIDED|95.0|0.96|2.4||A nominal p-value is provided.|Adjusting for Baseline||No correction for multiplicity was made.|||2.40|0.96|0.0765
72372850|NCT00635219|144256425|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.14||0.1436|TWO_SIDED|95.0|-0.47|0.07||A nominal p-value is provided.|ANCOVA||No correction for multiplicity was made.|||0.07|-0.47|0.1436
72372851|NCT00635219|144256425|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.17|STANDARD_ERROR_OF_MEAN|0.14||0.2114|TWO_SIDED|95.0|-0.44|0.1||A nominal p-value is provided.|ANCOVA||No correction for multiplicity was made.|||0.10|-0.44|0.2114
72493631|NCT03048422|144516473|SUPERIORITY||Risk Difference (RD)|-0.3||||0.95|TWO_SIDED|95.0|-9.3|8.6|||Wald test of two proportions|||Null hypothesis of no difference between groups (DTG+FTC/TDF - EFV/FTC/TDF).||8.6|-9.3|0.95
72555255|NCT00318461|144642194|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 0.6 mg + metformin and placebo + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|-1.53|||<|0.0001||95.0|-2.12|-0.94|||ANCOVA|||Change in fasting plasma glucose from baseline to end of treatment at 26 weeks was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline fasting plasma glucose as covariate.||-0.94|-2.12|<0.0001
72555256|NCT00318461|144642194|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 0.6 mg + metformin and glimepirde + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|0.18||||0.8079||95.0|-0.32|0.67|||ANCOVA|||Change in fasting plasma glucose from baseline to end of treatment at 26 weeks was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline fasting plasma glucose as covariate.||0.67|-0.32|0.8079
72555257|NCT00318461|144642195|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg + metformin and placebo + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|-1.93|||<|0.0001||95.0|-2.58|-1.28|||ANCOVA|||Change in fasting plasma glucose from baseline to end of treatment at 104 weeks was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline fasting plasma glucose as covariate.||-1.28|-2.58|<0.0001
72555258|NCT00318461|144642195|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg + metformin and glimepiride + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|-0.53||||0.0542||95.0|-1.08|0.01|||ANCOVA|||Change in fasting plasma glucose from baseline to end of treatment at 104 weeks was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline fasting plasma glucose as covariate.||0.01|-1.08|0.0542
72555259|NCT00318461|144642195|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.2 mg + metformin and placebo + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|-1.95|||<|0.0001||95.0|-2.6|-1.3|||ANCOVA|||Change in fasting plasma glucose from baseline to end of treatment at 104 weeks was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline fasting plasma glucose as covariate.||-1.30|-2.60|<0.0001
72618293|NCT00286455|144767658|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.154||||0.393|TWO_SIDED|95.0|-0.508|0.2||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.200|-0.508|0.393
72372852|NCT00635219|144256425|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.14||0.1389|TWO_SIDED|95.0|-0.47|0.07||A nominal p-value is provided.|ANCOVA||No correction for multiplicity was made.|||0.07|-0.47|0.1389
72372853|NCT00635219|144256425|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.21|STANDARD_ERROR_OF_MEAN|0.14||0.1271|TWO_SIDED|95.0|-0.48|0.06||A nominal p-value is provided.|ANCOVA||No correction for multiplicity was made.|||0.06|-0.48|0.1271
72372854|NCT00635219|144256426|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.15|STANDARD_ERROR_OF_MEAN|1.49||0.4421|TWO_SIDED|95.0|-4.08|1.79||A nominal p-value is provided.|ANCOVA||No correction for multiplicity was made.|||1.79|-4.08|0.4421
72372855|NCT00635219|144256426|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.15|STANDARD_ERROR_OF_MEAN|1.49||0.4399|TWO_SIDED|95.0|-4.07|1.77||A nominal p-value is provided.|ANCOVA||No correction for multiplicity was made.|||1.77|-4.07|0.4399
72372856|NCT00635219|144256426|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.37|STANDARD_ERROR_OF_MEAN|1.54||0.8093|TWO_SIDED|95.0|-2.65|3.4||A nominal p-value is provided.|ANCOVA||No correction for multiplicity was made.|||3.40|-2.65|0.8093
72372857|NCT00635219|144256426|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.6|STANDARD_ERROR_OF_MEAN|1.53||0.0897|TWO_SIDED|95.0|-5.61|0.41||A nominal p-value is provided.|ANCOVA||No correction for multiplicity was made.|||0.41|-5.61|0.0897
72372858|NCT00635219|144256427|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.41|STANDARD_ERROR_OF_MEAN|0.98||0.6748|TWO_SIDED|95.0|-2.35|1.52||A nominal p-value is provided.|ANCOVA||No correction for multiplicity was made.|||1.52|-2.35|0.6748
72372859|NCT00635219|144256427|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.7|STANDARD_ERROR_OF_MEAN|0.99||0.0871|TWO_SIDED|95.0|-3.64|0.25||A nominal p-value is provided.|ANCOVA||No correction for multiplicity was made.|||0.25|-3.64|0.0871
72372860|NCT00635219|144256427|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.99|STANDARD_ERROR_OF_MEAN|0.99||0.3186|TWO_SIDED|95.0|-2.94|0.96||A nominal p-value is provided.|ANCOVA||No correction for multiplicity was made.|||0.96|-2.94|0.3186
72372861|NCT00635219|144256427|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.8|STANDARD_ERROR_OF_MEAN|1.01||0.0768|TWO_SIDED|95.0|-3.79|0.19||A nominal p-value is provided.|ANCOVA||No correction for multiplicity was made.|||0.19|-3.79|0.0768
72372862|NCT00635219|144256428|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.13||||0.6258|TWO_SIDED|95.0|0.7|1.81||A nominal p-value is provided.|Adjusting for Baseline||No correction for multiplicity was made.|||1.81|0.70|0.6258
72372863|NCT00635219|144256428|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.09||||0.7178|TWO_SIDED|95.0|0.68|1.76||A nominal p-value is provided.|Adjusting for Baseline||No correction for multiplicity was made.|||1.76|0.68|0.7178
72372864|NCT00635219|144256428|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.96||||0.8651|TWO_SIDED|95.0|0.59|1.55||A nominal p-value is provided.|Adjusting for Baseline||No correction for multiplicity was made.|||1.55|0.59|0.8651
72372865|NCT00635219|144256428|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.05||||0.8563|TWO_SIDED|95.0|0.65|1.69||A nominal p-value is provided.|Adjusting for Baseline||No correction for multiplicity was made.|||1.69|0.65|0.8563
72372866|NCT00635219|144256429|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.12|STANDARD_ERROR_OF_MEAN|0.86||0.1925|TWO_SIDED|95.0|-2.82|0.57||A nominal p-value is provided.|ANCOVA||No correction for multiplicity was made.|||0.57|-2.82|0.1925
72372867|NCT00635219|144256429|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.01|STANDARD_ERROR_OF_MEAN|0.87||0.2434|TWO_SIDED|95.0|-2.72|0.69||A nominal p-value is provided.|ANCOVA||No correction for multiplicity was made.|||0.69|-2.72|0.2434
72372868|NCT00635219|144256429|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.86||0.7246|TWO_SIDED|95.0|-2.0|1.39||A nominal p-value is provided.|ANCOVA||No correction for multiplicity was made.|||1.39|-2.00|0.7246
72372869|NCT00635219|144256429|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.45|STANDARD_ERROR_OF_MEAN|0.87||0.0981|TWO_SIDED|95.0|-3.16|0.27||A nominal p-value is provided.|ANCOVA||No correction for multiplicity was made.|||0.27|-3.16|0.0981
72372870|NCT00635219|144256430|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.17|STANDARD_ERROR_OF_MEAN|0.14||0.2285|TWO_SIDED|95.0|-0.46|0.11||A nominal p-value is provided.|ANCOVA||No correction for multiplicity was made.|||0.11|-0.46|0.2285
72372871|NCT00635219|144256430|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.15||0.1794|TWO_SIDED|95.0|-0.48|0.09||A nominal p-value is provided.|ANCOVA||No correction for multiplicity was made.|||0.09|-0.48|0.1794
72372872|NCT00635219|144256430|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.14||0.1741|TWO_SIDED|95.0|-0.48|0.09||A nominal p-value is provided.|ANCOVA||No correction for multiplicity was made.|||0.09|-0.48|0.1741
72372873|NCT00635219|144256430|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.18|STANDARD_ERROR_OF_MEAN|0.15||0.2247|TWO_SIDED|95.0|-0.46|0.11||A nominal p-value is provided.|ANCOVA||No correction for multiplicity was made.|||0.11|-0.46|0.2247
72372874|NCT00635219|144256431|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.24|STANDARD_ERROR_OF_MEAN|0.86||0.7789|TWO_SIDED|95.0|-1.93|1.45||A nominal p-value is provided.|ANCOVA||No correction for multiplicity was made.|||1.45|-1.93|0.7789
72372875|NCT00635219|144256431|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.21|STANDARD_ERROR_OF_MEAN|0.87||0.8121|TWO_SIDED|95.0|-1.91|1.5||A nominal p-value is provided.|ANCOVA||No correction for multiplicity was made.|||1.50|-1.91|0.8121
72372876|NCT00635219|144256431|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.12|STANDARD_ERROR_OF_MEAN|0.87||0.8918|TWO_SIDED|95.0|-1.82|1.59||A nominal p-value is provided.|ANCOVA||No correction for multiplicity was made.|||1.59|-1.82|0.8918
72618294|NCT00286455|144767659|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.084||||0.703|TWO_SIDED|95.0|-0.348|0.515||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.515|-0.348|0.703
72372877|NCT00635219|144256431|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.03|STANDARD_ERROR_OF_MEAN|0.87||0.972|TWO_SIDED|95.0|-1.69|1.75||A nominal p-value is provided.|ANCOVA||No correction for multiplicity was made.|||1.75|-1.69|0.9720
72372878|NCT04075734|144256440|SUPERIORITY|||||||0.59|||||||Mixed Models Analysis|A linear mixed model for repeated measures was used. The group x time interaction evaluated the effect of the intervention over time.||||||0.59
72372879|NCT04075734|144256440|SUPERIORITY|||||||0.003|||||||Mixed Models Analysis|A linear mixed model for repeat measures was used. The group x time interaction evaluated the effect of the intervention over time.||||||0.003
72372880|NCT04075734|144256441|SUPERIORITY|||||||0.03|TWO_SIDED|95.0|||||Mixed Models Analysis|A linear mixed model for repeat measures was used. The group x time interaction evaluated the effect of the intervention over time.||||||0.03
72372881|NCT04075734|144256442|SUPERIORITY|||||||0.07|||||||Mixed Models Analysis|A linear mixed model for repeat measures was used. The group x time interaction evaluated the effect of the intervention over time.||||||0.07
72618295|NCT00286455|144767659|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.282||||0.203|TWO_SIDED|95.0|-0.153|0.717||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.717|-0.153|0.203
72372882|NCT04075734|144256443|SUPERIORITY|||||||0.2|||||||Mixed Models Analysis|A linear mixed model for repeat measures was used. The group x time interaction evaluated the effect of the intervention over time.||||||0.2
72372883|NCT04075734|144256444|SUPERIORITY|||||||0.006|||||||Mixed Models Analysis|A linear mixed model for repeat measures was used. The group x time interaction evaluated the effect of the intervention over time.||||||0.006
72372884|NCT04075734|144256445|SUPERIORITY|||||||0.86|||||||Mixed Models Analysis|A linear mixed model for repeated measures was used. The group x time interaction evaluated the effect of the intervention over time.||||||0.86
72372885|NCT04075734|144256446|SUPERIORITY|||||||0.14|||||||Mixed Models Analysis|A linear mixed model for repeated measures was used. The group x time interaction evaluated the effect of the intervention over time.||||||0.14
72372886|NCT04075734|144256447|SUPERIORITY|||||||0.02|||||||Mixed Models Analysis|A linear mixed model for repeated measures was used. The group x time interaction evaluated the effect of intervention over time.||||||0.02
72372887|NCT04075734|144256448|SUPERIORITY|||||||0.29|||||||Mixed Models Analysis|A linear mixed model for repeated measures was used. The group x time interaction evaluated the effect of the intervention over time.||||||0.29
72372888|NCT04075734|144256449|SUPERIORITY|||||||0.13|||||||Mixed Models Analysis|A linear mixed model for repeated measures was used. The group x time interaction evaluated the effect of the intervention over time.||||||0.13
72372889|NCT04075734|144256450|SUPERIORITY|||||||0.14|||||||Mixed Models Analysis|A linear mixed model for repeated measures was used. The group x time interaction evaluated the effect of the intervention over time.||||||0.14
72372890|NCT04075734|144256451|SUPERIORITY|||||||0.03|||||||Mixed Models Analysis|A linear mixed model for repeat measures was used. The group x time interaction evaluated the effect of the intervention over time.||||||0.03
72555260|NCT00318461|144642195|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.2 mg + metformin and glimepirde + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|-0.55||||0.0451||95.0|-1.1|-0.01|||ANCOVA|||Change in fasting plasma glucose from baseline to end of treatment at 104 weeks was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline fasting plasma glucose t as covariate.||-0.01|-1.10|0.0451
72555261|NCT00318461|144642195|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 0.6 mg + metformin and placebo + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|-1.55|||<|0.0001||95.0|-2.2|-0.9|||ANCOVA|||Change in fasting plasma glucose from baseline to end of treatment at 104 weeks was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline fasting plasma glucose as covariate.||-0.90|-2.20|<0.0001
72555262|NCT00318461|144642195|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 0.6 mg + metformin and glimepirde + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|-0.15||||0.9006||95.0|-0.7|0.39|||ANCOVA|||Change in fasting plasma glucose from baseline to end of treatment at 104 weeks was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline fasting plasma glucose as covariate.||0.39|-0.70|0.9006
72555263|NCT00318461|144642196|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg + metformin and placebo + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|-0.13||||0.8871||95.0|-0.62|0.36|||ANCOVA|||Change in prandial increments of plasma glucose from baseline to 26 weeks of treatment was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.||0.36|-0.62|0.8871
72555264|NCT00318461|144642196|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg + metformin and glimepiride + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|-0.12||||0.8695||95.0|-0.51|0.27|||ANCOVA|||Change in prandial increments of plasma glucose from baseline to 26 weeks of treatment was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.||0.27|-0.51|0.8695
72555265|NCT00318461|144642196|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.2 mg + metformin and placebo + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|0.03||||0.9994||95.0|-0.46|0.52|||ANCOVA|||Change in prandial increments of plasma glucose from baseline to 26 weeks of treatment was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.||0.52|-0.46|0.9994
72555266|NCT00318461|144642196|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.2 mg + metformin and glimepirde + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|0.04||||0.9984||95.0|-0.35|0.43|||ANCOVA|||Change in prandial increments of plasma glucose from baseline to 26 weeks of treatment was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.||0.43|-0.35|0.9984
72493632|NCT03048422|144516473|SUPERIORITY||Risk Difference (RD)|-9.1||||0.037|TWO_SIDED|95.0|-17.6|-0.6|||Wald test of two proportions|||Null hypothesis of no difference between groups (DTG+FTC/TAF - EFV/FTC/TDF).||-0.6|-17.6|0.037
72493633|NCT03048422|144516474|SUPERIORITY||Odds Ratio (OR)|0.73||||0.095|TWO_SIDED|95.0|0.5|1.06|||Regression, Ordinal|||Null hypothesis of odds ratio equal to 1, with odds of experiencing a worse outcome equal between groups (DTG+FTC/TAF - DTG+FTC/TDF).||1.06|0.50|0.095
72555267|NCT00318461|144642196|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 0.6 mg + metformin and placebo + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|0.21||||0.6201||95.0|-0.28|0.7|||ANCOVA|||Change in mean prandial increments of plasma glucose from baseline to 26 weeks of treatment was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.||0.70|-0.28|0.6201
72493634|NCT03048422|144516474|SUPERIORITY||Odds Ratio (OR)|0.83||||0.3|TWO_SIDED|95.0|0.58|1.19|||Regression, Ordinal|||Null hypothesis of odds ratio equal to 1, with odds of experiencing a worse outcome equal between groups (DTG+FTC/TDF - EFV/FTC/TDF).||1.19|0.58|0.30
72493635|NCT03048422|144516474|SUPERIORITY||Odds Ratio (OR)|0.6||||0.008|TWO_SIDED|95.0|0.42|0.88|||Regression, Ordinal|||Null hypothesis of odds ratio equal to 1, with odds of experiencing a worse outcome equal between groups (DTG+FTC/TAF - EFV/FTC/TDF).||0.88|0.42|0.008
72493636|NCT03048422|144516475|SUPERIORITY||Risk Difference (RD)|0.5||||0.28|TWO_SIDED|95.0|-1.2|2.1|||Z-test|||The Kaplan-Meier method was used to estimate survival probabilities. Survival probabilities were compared based on a Z-test using Greenwoods estimate of the standard error. The null hypothesis was no difference between arms (DTG+FTC/TAF - DTG+FTC/TDF).||2.1|-1.2|0.28
72622347|NCT03654326|144774548|OTHER|The difference in least squares mean was based on the longitudinal analysis of covariance (ANCOVA) model including factors for average pelvic pain scores at baseline cycle, stratum, treatment, cycle, interaction of stratum-by-cycle, and the interaction of treatment-by-cycle as covariates|Difference in Least Squares Mean|-0.5|||||TWO_SIDED|95.0|-1.04|0.03||||||||0.03|-1.04|
72372891|NCT04075734|144256452|SUPERIORITY|||||||0.66|||||||Mixed Models Analysis|A linear mixed model for repeated measures was used. The group x time interaction evaluated the effect of the intervention over time.||||||0.66
72372892|NCT04075734|144256453|SUPERIORITY|||||||0.15|||||||Mixed Models Analysis|A linear mixed model for repeated measures was used. The group x time interaction evaluated the effect of the intervention over time.||||||0.15
72372893|NCT02250703|144256463|SUPERIORITY_OR_OTHER|||||||0.025||||||Difference in proportions in satisfactory sedation on separation from parents and on induction between M and D groups (Primary Outcome variables)|Chi-squared|||A sample size of at least 33 patients in each group would detect at least 30% difference in proportion of children who achieve satisfactory sedation between the M and D groups at 0.05 level of significance and 80% power||||0.025
72372894|NCT02250703|144256464|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Chi-squared|||||||>0.05
72372895|NCT02250703|144256465|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Chi-squared|||||||>0.05
72372896|NCT02250703|144256466|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Chi-squared|||||||>0.05
72372897|NCT00322621|144256475|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin of 1.5 point on the BPI 24-hour average pain scale.|Mean Difference (Net)|0.35|||<|0.001||97.5|0.35|0.79||Significance level 0.025|t-test, 1 sided|||Null hypothesis is that duloxetine treatment effect on pain reduction in diabetic peripheral neuropathic pain (DPNP) is not maintained, as indicated by an increase of more than 1.5 point on the BPI 24-hour average pain scale. Null hypothesis is rejected at significance level 0.025 if the upper bound of one-sided 97.5% CI is less than or equal to non-inferiority margin of 1.5 point.||0.79|0.35|<0.001
72372898|NCT00322621|144256478|SUPERIORITY_OR_OTHER|||||||0.269||95.0|||||t-test, 2 sided|||||||0.269
72372899|NCT00322621|144256479|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||||||<0.001
72372900|NCT00322621|144256480|SUPERIORITY_OR_OTHER|||||||0.16||95.0|||||t-test, 2 sided|||||||0.160
72372901|NCT00322621|144256481|SUPERIORITY_OR_OTHER|||||||0.016||95.0|||||t-test, 2 sided|||||||0.016
72372902|NCT00322621|144256482|SUPERIORITY_OR_OTHER|||||||0.075||95.0|||||t-test, 2 sided|||||||0.075
72372903|NCT00322621|144256483|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||||||<0.001
72372904|NCT00322621|144256484|SUPERIORITY_OR_OTHER|||||||0.026||95.0|||||t-test, 2 sided|||||||0.026
72372905|NCT00322621|144256485|SUPERIORITY_OR_OTHER|||||||0.011||95.0|||||t-test, 2 sided|||||||0.011
72372906|NCT00322621|144256486|SUPERIORITY_OR_OTHER|||||||0.406||95.0|||||t-test, 2 sided|||||||0.406
72372907|NCT00322621|144256487|SUPERIORITY_OR_OTHER|||||||0.021||95.0|||||t-test, 2 sided|||||||0.021
72372908|NCT00322621|144256488|SUPERIORITY_OR_OTHER|||||||0.124||95.0|||||t-test, 2 sided|||||||0.124
72372909|NCT00322621|144256489|SUPERIORITY_OR_OTHER|||||||0.505||95.0|||||t-test, 2 sided|||||||0.505
72372910|NCT00322621|144256490|SUPERIORITY_OR_OTHER|||||||0.058||95.0|||||t-test, 2 sided|||||||0.058
72372911|NCT00322621|144256491|SUPERIORITY_OR_OTHER|||||||0.009||95.0|||||t-test, 2 sided|||||||0.009
72372912|NCT00322621|144256492|SUPERIORITY_OR_OTHER|||||||0.016||95.0|||||t-test, 2 sided|||||||0.016
72372913|NCT00322621|144256493|SUPERIORITY_OR_OTHER|||||||0.022||95.0|||||t-test, 2 sided|||||||0.022
72372914|NCT00322621|144256494|SUPERIORITY_OR_OTHER|||||||0.55||95.0|||||t-test, 2 sided|||||||0.550
72372915|NCT00322621|144256495|SUPERIORITY_OR_OTHER|||||||0.752||95.0|||||t-test, 2 sided|||||||0.752
72372916|NCT00322621|144256496|SUPERIORITY_OR_OTHER|||||||0.713||95.0|||||t-test, 2 sided|||||||0.713
72372917|NCT00322621|144256497|SUPERIORITY_OR_OTHER|||||||0.066||95.0|||||t-test, 2 sided|||||||0.066
72372918|NCT00322621|144256498|SUPERIORITY_OR_OTHER|||||||0.711||95.0|||||t-test, 2 sided|||||||0.711
72372919|NCT00322621|144256499|SUPERIORITY_OR_OTHER|||||||0.678||95.0|||||t-test, 2 sided|||||||0.678
72372920|NCT00322621|144256500|SUPERIORITY_OR_OTHER|||||||0.216||95.0|||||t-test, 2 sided|||||||0.216
72372921|NCT00322621|144256501|SUPERIORITY_OR_OTHER|||||||0.113||95.0|||||t-test, 2 sided|||||||0.113
72372922|NCT00322621|144256504|SUPERIORITY_OR_OTHER|||||||0.368||95.0|||||t-test, 2 sided|||||||0.368
72372923|NCT00322621|144256505|SUPERIORITY_OR_OTHER|||||||0.003||95.0|||||t-test, 2 sided|||||||0.003
72372924|NCT00322621|144256506|SUPERIORITY_OR_OTHER|||||||0.666||95.0|||||t-test, 2 sided|||||||0.666
72372925|NCT00322621|144256507|SUPERIORITY_OR_OTHER|||||||0.138||95.0|||||t-test, 2 sided|||||||0.138
72372926|NCT00322621|144256508|SUPERIORITY_OR_OTHER|||||||0.145||95.0|||||t-test, 2 sided|||||||0.145
72372927|NCT00322621|144256509|SUPERIORITY_OR_OTHER|||||||0.512||95.0|||||t-test, 2 sided|||||||0.512
72372928|NCT02059291|144256516|SUPERIORITY||||||<|0.0001|||||||Fisher's exact test|||||||<0.0001
72372929|NCT02059291|144256516|SUPERIORITY|||||||0.002|||||||Fisher's exact test|||||||0.0020
72372930|NCT02059291|144256516|SUPERIORITY|||||||0.005|||||||Fisher's exact test|||||||0.0050
72372931|NCT02059291|144256517|SUPERIORITY||Odds Ratio (OR)|16.96|||<|0.0001|TWO_SIDED|95.0|4.15|69.21|||Regression, Logistic|||||69.21|4.15|<0.0001
72372932|NCT02059291|144256517|SUPERIORITY||Odds Ratio (OR)|13.63||||0.0006|TWO_SIDED|95.0|2.83|65.59|||Regression, Logistic|||||65.59|2.83|0.0006
72372933|NCT02059291|144256517|SUPERIORITY||Odds Ratio (OR)|23.79||||0.0028|TWO_SIDED|95.0|2.52|224.86|||Regression, Logistic|||||224.86|2.52|0.0028
72372934|NCT02059291|144256518|SUPERIORITY||Odds Ratio (OR)|29.78|||<|0.0001|TWO_SIDED|95.0|5.86|151.31|||Regression, Logistic|||||151.31|5.86|<0.0001
72372935|NCT02059291|144256518|SUPERIORITY||Odds Ratio (OR)|12.71||||0.001|TWO_SIDED|95.0|2.53|63.89|||Regression, Logistic|||||63.89|2.53|0.0010
72372936|NCT02059291|144256518|SUPERIORITY||Odds Ratio (OR)|6.64||||0.0149|TWO_SIDED|95.0|1.2|36.57|||Regression, Logistic|||||36.57|1.20|0.0149
72372937|NCT02059291|144256519|SUPERIORITY||Odds Ratio (OR)|17.46||||0.0286|TWO_SIDED|95.0|0.92|332.92|||Regression, Logistic|||||332.92|0.92|0.0286
72372938|NCT02059291|144256519|SUPERIORITY||Odds Ratio (OR)|5.26||||0.0778|TWO_SIDED|95.0|0.53|51.97|||Regression, Logistic|||||51.97|0.53|0.0778
72372939|NCT02059291|144256519|SUPERIORITY||Odds Ratio (OR)|16.69||||0.0235|TWO_SIDED|95.0|1.04|268.5|||Regression, Logistic|||||268.50|1.04|0.0235
72555268|NCT00318461|144642196|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 0.6 mg + metformin and glimepirde + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|0.21||||0.4831||95.0|-0.18|0.6|||ANCOVA|||Change in mean prandial increments of plasma glucose from baseline to 26 weeks of treatment was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.||0.60|-0.18|0.4831
72555269|NCT00318461|144642197|NON_INFERIORITY_OR_EQUIVALENCE|Hypothesis testing was done in a hierarchical manner. First, it was tested whether liraglutide 1.8 mg+metformin was superior to placebo + metformin. Superiority was always concluded if the upper limit of the 2-sided 95% CI for the treatment difference was below 0%.|Estimated treatment difference, LS Mean|-0.83|||<|0.0001||95.0|-1.07|-0.59|||ANCOVA|||Change in HbA1c from baseline to end of treatment at 104 weeks was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline glycosylated A1c (HbA1c) as covariate.||-0.59|-1.07|<0.0001
72555270|NCT00318461|144642197|NON_INFERIORITY_OR_EQUIVALENCE|Hypothesis testing was done in a hierarchical manner. As superiority of liraglutide 1.8 mg + metformin to metformin monotherapy was established, it was investigated whether liraglutide 1.8 mg + metformin was non-inferior to glimepiride + metformin. Non-inferiority was concluded if the upper limit of the 2-sided 95% CI for the treatment difference was below 0.4%.|Estimated treatment difference, LS Mean|-0.08|||<|0.0001||95.0|-0.28|0.12|||ANCOVA|||Change in HbA1c from baseline to end of treatment at 104 weeks was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline glycosylated A1c (HbA1c) as covariate.||0.12|-0.28|<0.0001
72555271|NCT00318461|144642197|NON_INFERIORITY_OR_EQUIVALENCE|Hypothesis testing was done in a hierarchical manner. First, it was tested whether liraglutide 1.2 mg+metformin was superior to placebo + metformin. Superiority was always concluded if the upper limit of the 2-sided 95% CI for the treatment difference was below 0%.|Estimated treatment difference, LS Mean|-0.81|||<|0.0001||95.0|-1.05|-0.57|||ANCOVA|||Change in HbA1c from baseline to end of treatment was at 104 weeks analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline glycosylated A1c (HbA1c) as covariate.||-0.57|-1.05|<0.0001
72555272|NCT00318461|144642197|NON_INFERIORITY_OR_EQUIVALENCE|Hypothesis testing was done in a hierarchical manner. As superiority of liraglutide 1.2 mg + metformin to metformin monotherapy was established, it was investigated whether liraglutide 1.2 mg + metformin was non-inferior to glimepiride + metformin. Non-inferiority was concluded if the upper limit of the 2-sided 95% CI for the treatment difference was below 0.4%.|Estimated treatment difference, LS Mean|-0.07|||<|0.0001||95.0|-0.27|0.13|||ANCOVA|||Change in HbA1c from baseline to end of treatment at 104 weeks was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline glycosylated A1c (HbA1c) as covariate.||0.13|-0.27|<0.0001
72618296|NCT00286455|144767660|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.169||||0.408|TWO_SIDED|95.0|-0.232|0.569||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.569|-0.232|0.408
72493637|NCT03048422|144516475|SUPERIORITY||Risk Difference (RD)|-0.1||||0.47|TWO_SIDED|95.0|-1.5|1.4|||Z-test|||The Kaplan-Meier method was used to estimate survival probabilities. Survival probabilities were compared based on a Z-test using Greenwoods estimate of the standard error. The null hypothesis was no difference between arms (DTG+FTC/TDF - EFV/FTC/TDF).||1.4|-1.5|0.47
72372940|NCT02059291|144256520|SUPERIORITY||Odds Ratio (OR)|8.17||||0.0513|TWO_SIDED|95.0|0.75|113.44|||Regression, Logistic|||||113.44|0.75|0.0513
72493638|NCT03048422|144516475|SUPERIORITY||Risk Difference (RD)|0.4||||0.31|TWO_SIDED|95.0|-1.3|2.2|||Z-test|||The Kaplan-Meier method was used to estimate survival probabilities. Survival probabilities were compared based on a Z-test using Greenwoods estimate of the standard error. The null hypothesis was no difference between arms (DTG+FTC/TAF - EFV/FTC/TDF).||2.2|-1.3|0.31
72493639|NCT03048422|144516476|SUPERIORITY|The Kaplan-Meier method was used to estimate survival probabilities. Comparisons of survival probabilities was based on a Z-test using Greenwoods estimate of the standard error. The null hypothesis was no difference between arms, with estimated difference of DTG+FTC/TAF - DTG+FTC/TDF.|Risk Difference (RD)|-1.0||||0.2|TWO_SIDED|95.0|-3.4|1.3|||Z-test|||||1.3|-3.4|0.20
72493640|NCT03048422|144516476|SUPERIORITY||Risk Difference (RD)|-4.9||||0.008|TWO_SIDED|95.0|-8.9|-0.9|||Z-test|||The Kaplan-Meier method was used to estimate survival probabilities. Comparisons of survival probabilities was based on a Z-test using Greenwoods estimate of the standard error. The null hypothesis was no difference between arms, with estimate of risk difference DTG+FTC/TDF-EFV/FTC/TDF.||-0.9|-8.9|0.008
72493641|NCT03048422|144516476|SUPERIORITY||Risk Difference (RD)|-5.9|||<|0.001|TWO_SIDED|95.0|-9.7|-2.2|||Z-test|||The Kaplan-Meier method was used to estimate survival probabilities. Comparisons of survival probabilities was based on a Z-test using Greenwoods estimate of the standard error. The null hypothesis was no difference between arms, with estimate of risk difference DTG+FTC/TAF-EFV/FTC/TDF.||-2.2|-9.7|<0.001
72493642|NCT03048422|144516477|SUPERIORITY||Mean Difference (Final Values)|-0.093||||0.12|TWO_SIDED|95.0|-0.208|0.023|||Generalized Estimating Equation|||Null hypothesis of no difference in weekly change in creatinine clearance from baseline (DTG+FTC/TAF - DTG+FTC/TDF).||0.023|-0.208|0.12
72493643|NCT03048422|144516477|SUPERIORITY||Mean Difference (Final Values)|0.048||||0.39|TWO_SIDED|95.0|-0.061|0.158|||Generalized Estimating Equation|||Null hypothesis of no difference in weekly change in creatinine clearance from baseline (DTG+FTC/TDF - EFV/FTC/TDF).||0.158|-0.061|0.39
72493644|NCT03048422|144516477|SUPERIORITY||Mean Difference (Final Values)|-0.045||||0.45|TWO_SIDED|95.0|-0.161|0.072|||Generalized Estimating Equation|||Null hypothesis of no difference in weekly change in creatinine clearance from baseline (DTG+FTC/TAF - EFV/FTC/TDF).||0.072|-0.161|0.45
72493645|NCT03048422|144516478|SUPERIORITY||Mean Difference (Final Values)|-0.4||||0.94|TWO_SIDED|95.0|-11.3|10.5|||t-test, 2 sided|||Null hypothesis of no difference between arms at delivery (DTG+FTC/TAF - DTG+FTC/TDF).||10.5|-11.3|0.94
72555273|NCT00318461|144642197|NON_INFERIORITY_OR_EQUIVALENCE|"Hypothesis testing was done in a hierarchical manner. First, it was tested whether liraglutide 0.6 mg+metformin was superior to placebo + metformin.~Superiority was always concluded if the upper limit of the 2-sided 95% CI for the treatment difference was below 0%."|Estimated treatment difference, LS Mean|-0.61|||<|0.0001||95.0|-0.85|-0.37|||ANCOVA|||Change in HbA1c from baseline to end of treatment at 104 weeks was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline glycosylated A1c (HbA1c) as covariate.||-0.37|-0.85|<0.0001
72555274|NCT00318461|144642197|NON_INFERIORITY_OR_EQUIVALENCE|Hypothesis testing was done in a hierarchical manner. As superiority of liraglutide 0.6 mg + metformin to metformin monotherapy was established, it was investigated whether liraglutide 0.6 mg + metformin was non-inferior to glimepiride + metformin. Non-inferiority was concluded if the upper limit of the 2-sided 95% CI for the treatment difference was below 0.4%.|Estimated treatment difference, LS Mean|0.14||||0.0052||95.0|-0.06|0.34|||ANCOVA|||Change in HbA1c from baseline to end of treatment at 104 weeks was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline glycosylated A1c (HbA1c) as covariate.||0.34|-0.06|0.0052
72555275|NCT00318461|144642197|NON_INFERIORITY_OR_EQUIVALENCE|A test for superiority of glimepiride+metformin to placebo metformin was performed to verify assay sensitivity. Superiority was always concluded if the upper limit of the 2-sided 95% CI for the treatment difference was below 0%.|Estimated treatment difference, LS Mean|-0.75|||<|0.0001||95.0|-0.99|-0.51|||ANCOVA|||Change in HbA1c from baseline to end of treatment at 104 weeks was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline glycosylated A1c (HbA1c) as covariate.||-0.51|-0.99|<0.0001
72555276|NCT00318461|144642198|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg + metformin and placebo + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|-0.24||||0.5282||95.0|-0.74|0.26|||ANCOVA|||Change in prandial increments of plasma glucose from baseline to 104 weeks of treatment was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.||0.26|-0.74|0.5282
72555277|NCT00318461|144642198|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg + metformin and glimepiride + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|-0.15||||0.7644||95.0|-0.55|0.25|||ANCOVA|||Change in prandial increments of plasma glucose from baseline to 104 weeks of treatment was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.||0.25|-0.55|0.7644
72555278|NCT00318461|144642198|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.2 mg + metformin and placebo + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|-0.36||||0.2063||95.0|-0.86|0.14|||ANCOVA|||Change in prandial increments of plasma glucose from baseline to 104 weeks of treatment was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.||0.14|-0.86|0.2063
72555279|NCT00318461|144642198|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.2 mg + metformin and glimepirde + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|-0.28||||0.2678||95.0|-0.68|0.12|||ANCOVA|||Change in prandial increments of plasma glucose from baseline to 104 weeks of treatment was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.||0.12|-0.68|0.2678
72555280|NCT00318461|144642198|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 0.6 mg + metformin and placebo + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|-0.07||||0.9887||95.0|-0.57|0.43|||ANCOVA|||Change in prandial increments of plasma glucose from baseline to 104 weeks of treatment was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.||0.43|-0.57|0.9887
72555281|NCT00318461|144642198|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 0.6 mg + metformin and glimepirde + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|0.02||||0.9998||95.0|-0.38|0.42|||ANCOVA|||Change in prandial increments of plasma glucose from baseline to 104 weeks of treatment was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.||0.42|-0.38|0.9998
72372941|NCT02059291|144256520|SUPERIORITY||Odds Ratio (OR)|6.0||||0.2168|TWO_SIDED|95.0|0.27|366.24|||Regression, Logistic|||||366.24|0.27|0.2168
72372942|NCT02059291|144256520|SUPERIORITY||Odds Ratio (OR)|4.5||||0.3571|TWO_SIDED|95.0|0.15|313.49|||Regression, Logistic|||||313.49|0.15|0.3571
72372943|NCT01433289|144256522|SUPERIORITY||||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||The study hypothesis tested whether Polyphenon E given twice daily for 14 days at the specified doses has an effect on antiviral activity compared with placebo, measured by differences from baseline to day 14 in plasma HIV-1 RNA level (log10 copies/mL). The Wilcoxon signed-rank test was used to test the null hypothesis that there was no change at Day 14 versus baseline.||||>0.05
72372944|NCT01433289|144256522|SUPERIORITY|||||||0.74||||||Analysis was stratified by treatment group. The Kruskal-Wallis test was used to compare the change of log10 HIV-1 RNA copies/ml between treatment groups.|Kruskal-Wallis|||||||0.74
72555282|NCT00318461|144642199|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg + metformin and placebo + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|-1.95|||<|0.0001||95.0|-2.6|-1.3|||ANCOVA|||Change in post prandial increments of plasma glucose from baseline to 26 weeks of treatment was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.||-1.30|-2.60|<0.0001
72555283|NCT00318461|144642199|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg + metformin and glimepiride + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|-0.11||||0.967||95.0|-0.62|0.41|||ANCOVA|||Change in post prandial increments of plasma glucose from baseline to 26 weeks of treatment was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.||0.41|-0.62|0.9670
72555284|NCT00318461|144642199|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.2 mg + metformin and placebo + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|-1.72|||<|0.0001||95.0|-2.36|-1.07|||ANCOVA|||Change in post prandial increments of plasma glucose from baseline to 26 weeks of treatment was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.||-1.07|-2.36|<0.0001
72555285|NCT00318461|144642199|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.2 mg + metformin and glimepirde + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|0.13||||0.9368||95.0|-0.39|0.64|||ANCOVA|||Change in post prandial increments of plasma glucose from baseline to 26 weeks of treatment was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.||0.64|-0.39|0.9368
72555286|NCT00318461|144642199|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 0.6 mg + metformin and placebo + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|-1.06||||0.0003||95.0|-1.71|-0.42|||ANCOVA|||Change in post prandial increments of plasma glucose from baseline to 26 weeks of treatment was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.||-0.42|-1.71|0.0003
72555287|NCT00318461|144642199|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 0.6 mg + metformin and glimepirde + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|0.78||||0.0008||95.0|0.27|1.29|||ANCOVA|||Change in post prandial increments of plasma glucose from baseline to 26 weeks of treatment was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.||1.29|0.27|0.0008
72555288|NCT00318461|144642200|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg + metformin and placebo + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|-1.66|||<|0.0001||95.0|-2.37|-0.96|||ANCOVA|||Change in post prandial increments of plasma glucose from baseline to 104 weeks of treatment was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.||-0.96|-2.37|<0.0001
72493646|NCT03048422|144516478|SUPERIORITY||Mean Difference (Final Values)|4.2||||0.44|TWO_SIDED|95.0|-6.5|14.9|||t-test, 2 sided|||Null hypothesis of no difference between arms at delivery (DTG+FTC/TDF - EFV/FTC/TDF).||14.9|-6.5|0.44
72555289|NCT00318461|144642200|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg + metformin and glimepiride + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|-0.3||||0.5048||95.0|-0.86|0.26|||ANCOVA|||Change in post prandial increments of plasma glucose from baseline to 104 weeks of treatment was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.||0.26|-0.86|0.5048
72555290|NCT00318461|144642200|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.2 mg + metformin and placebo + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|-1.79|||<|0.0001||95.0|-2.49|-1.08|||ANCOVA|||Change in post prandial increments of plasma glucose from baseline to 104 weeks of treatment was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.||-1.08|-2.49|<0.0001
72555291|NCT00318461|144642200|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.2 mg + metformin and glimepirde + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|-0.42||||0.2005||95.0|-0.98|0.14|||ANCOVA|||Change in post prandial increments of plasma glucose from baseline to 104 weeks of treatment was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.||0.14|-0.98|0.2005
72372945|NCT01763996|144256526|SUPERIORITY_OR_OTHER||LS Mean Difference|1.8||||0.756|TWO_SIDED|95.0|-10.1|13.76||0.05 level of significance|ANOVA|Analysis of variance (ANOVA) model that includes sequence, period, and treatment as fixed factors and subjects within sequence as a random factor.||||13.76|-10.10|0.756
72372946|NCT00865280|144256537|NON_INFERIORITY|A non-inferiority margin of 10% was used for the analysis.|treatment difference|-2.0|||||TWO_SIDED|95.0|-12.4|8.5|||||The 95% confidence interval (CI) was based on a normal approximation to the binomial distribution with continuity correction. Treatment difference for a response of clinical success was calculated as omadacycline minus linezolid.|||8.5|-12.4|
72372947|NCT00865280|144256538|NON_INFERIORITY|A non-inferiority margin of 10% was used for the analysis.|treatment difference|-3.6|||||TWO_SIDED|95.0|-15.5|8.3|||||The 95% CI was based on a normal approximation to the binomial distribution with continuity correction. Treatment difference for a response of clinical success was calculated as omadacycline minus linezolid.|||8.3|-15.5|
72372948|NCT00865280|144256539|NON_INFERIORITY|A non-inferiority margin of 10% was used for the analysis.|treatment difference|7.7|||||TWO_SIDED|95.0|-11.2|26.6|||||The 95% CI was based on a normal approximation to the binomial distribution with continuity correction. Treatment difference for a response of clinical success was calculated as omadacycline minus linezolid.|||26.6|-11.2|
72372949|NCT00865280|144256540|NON_INFERIORITY|A non-inferiority margin of 10% was used for the analysis.|treatment difference|-0.3|||||TWO_SIDED|95.0|-8.3|7.6|||||The 95% CI was based on a normal approximation to the binomial distribution with continuity correction. Treatment difference for a response of clinical success was calculated as omadacycline minus linezolid.|||7.6|-8.3|
72372950|NCT00865280|144256541|NON_INFERIORITY|A non-inferiority margin of 10% was used for the analysis.|treatment difference|7.7|||||TWO_SIDED|95.0|-11.2|26.6|||||The 95% CI was based on a normal approximation to the binomial distribution with continuity correction. Treatment difference for a response of clinical success was calculated as omadacycline minus linezolid.|||26.6|-11.2|
72372951|NCT00865280|144256542|NON_INFERIORITY|A non-inferiority margin of 10% was used for the analysis.|treatment difference|-0.3|||||TWO_SIDED|95.0|-8.3|7.6|||||The 95% CI was based on a normal approximation to the binomial distribution with continuity correction. Treatment difference for a response of clinical success was calculated as omadacycline minus linezolid.|||7.6|-8.3|
72372952|NCT00612105|144256555|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.43||||0.2537|TWO_SIDED|95.0|-1.171|0.312|||ANCOVA|||||0.312|-1.171|0.2537
72372953|NCT00743106|144256580|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.0||||0.15|TWO_SIDED|95.0|-31.0|9.0|||Wilcoxon (Mann-Whitney)||The mean decrease in GFR was an estimated 11% less for fenoldopam than for placebo (interim-adjusted 95% confidence interval 9% more, 31% less).|||9|-31|0.15
72372954|NCT00743106|144256581|SUPERIORITY||ratio of geometric mean|0.98||||0.78|TWO_SIDED|95.0|0.79|1.19|||Mixed Models Analysis|||We assessed the effect of fenoldopam on creatinine over time (immediately postoperatively and on PODs 1-4). A linear mixed effects model was used to assess the main effect of fenoldopam on the postoperative log-transformed (base 2) serum creatinine, adjusting for baseline serum creatinine.||1.19|0.79|0.78
72372955|NCT00993226|144256583|SUPERIORITY||LS Mean Difference|-0.21|STANDARD_DEVIATION|0.29||0.467|TWO_SIDED|95.0|-0.79|0.36|||t-test in ANOVA model|||Exploratory comparison between SABER-Bupivacaine and Bupivacaine HCl not analyzed inferentially||0.36|-0.79|0.467
72372956|NCT00993226|144256584|SUPERIORITY||LS Mean Difference|-2.51|STANDARD_DEVIATION|2.57||0.331|TWO_SIDED|95.0|-7.59|2.58|||t-test in ANOVA model|||Exploratory comparison between SABER-Bupivacaine and Bupivacaine HCl not analyzed inferentially||2.58|-7.59|0.331
72432534|NCT00783692|144377701|SUPERIORITY_OR_OTHER||Risk Difference (RD)|14.7||||0.0042|TWO_SIDED|95.0|4.6|24.7||CMH chi-square test, stratified by: 1) concomitant use of oral corticosteroids (yes/no); 2) previous exposure to TNFα antagonists and/or concomitant immunomodulator use (yes/no); 3) enrollment in Cohort 1 or Cohort 2 in the Induction Phase.|Cochran-Mantel-Haenszel||Risk Difference = adjusted (for stratification factors) percent vedolizumab - adjusted percent placebo|The Hochberg method was applied to control the overall Type I error rate at a 5% significance level. If both p-values were ≤ 0.05, both dose regimens were to be declared significant. If 1 of the p-values for the 2 dose comparisons was \> 0.05, the other p-value was to be tested at the 0.025 level and declared significant only if the p-value was ≤ 0.025. If neither dose was declared significant for the primary endpoint, no further testing was to be conducted.||24.7|4.6|0.0042
72372957|NCT02874144|144256588|SUPERIORITY|intention-to-treat with participants analyzed according to a randomly assigned treatment group irrespective of compliance.|Slope|0.0|STANDARD_ERROR_OF_MEAN|0.0|<|0.05|TWO_SIDED|||||The reported p-value was calculated, and is not attempting to indicate the threshold for statistical significance.|Regression, Linear|||We used baseline scores to track change to follow-up scores and used a difference-in-differences (D-I-D) statistical approach to compare the change over time compare relative rate of change over time between scores within the treatment group (AZD1981 plus INCS) and within the to scores within the placebo group (INCS treatment only)..|For inflammatory mediator analyses, data were reported as mean (SEM) with statistical significance determined by Kruskal-Wallis test.|||<0.05
72372958|NCT02874144|144256588|SUPERIORITY|This was a superiority trial. We used repeated-measures linear regression using the mixed procedure to calculate means for each outcome by visits and treatment status. We used baseline scores to track change to follow-up scores and used a difference-in-differences (D-I-D) statistical approach to compare the change over time between scores within the treatment group (AZD1981 plus INCS) to scores within the placebo group (INCS treatment only).|Mean Difference (Final Values)|-20.0|||<|0.05|TWO_SIDED|||||No, the p-value was not adjusted for multiple comparisons.|repeated-measures linear regression|We used repeated-measures linear regression using the MIXED procedure to calculate means (SEMS) for each outcome by visits and treatment status.|Our study did not include at relative risk.|The trial design is a continuous outcome superiority trial with primary efficacy outcome measures of change in Total Polyp Score (TPS) comparing AZD to placebo arm from V1 to V5. Total polyp score is a standardized method for assessing nasal polyp size by endoscopy, based on a scale of 1-4 per side. Inclusion criterion for this study is a TPS of ≥4 with a maximum of 8 and a standard deviation ± 2. A clinically meaningful effect is considered to be a decrease in total polyp score of 1.5.||||<0.05
72372959|NCT02975557|144256600|OTHER|||||||1|||||||Fisher Exact|The type I error was adjusted by using the alpha spending function approach with O'Brien-Fleming type boundaries.||We evaluated if the categorical type of tolerability measure is different between control (Artificial Tears) and intervention (Brimonidine, including both 0.15% high and 0.075% low doses groups).||||1
72555292|NCT00318461|144642200|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 0.6 mg + metformin and placebo + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|-1.16||||0.0003||95.0|-1.86|-0.46|||ANCOVA|||Change in post prandial increments of plasma glucose from baseline to 104 weeks of treatment was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.||-0.46|-1.86|0.0003
72555293|NCT00318461|144642200|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 0.6 mg + metformin and glimepirde + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|0.21||||0.7871||95.0|-0.35|0.76|||ANCOVA|||Change in post prandial increments of plasma glucose from baseline to 104 weeks of treatment was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.||0.76|-0.35|0.7871
72555294|NCT00318461|144642201|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg + metformin and placebo + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|27.75||||0.0031||95.0|7.83|47.67|||ANCOVA|||Change in HOMA-B from baseline to 26 weeks of treatment was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.||47.67|7.83|0.0031
72555295|NCT00318461|144642201|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg + metformin and glimepiride + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|1.44||||0.9987||95.0|-15.03|17.9|||ANCOVA|||Change in HOMA-B from baseline to 26 weeks of treatment was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.||17.90|-15.03|0.9987
72555296|NCT00318461|144642201|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.2 mg + metformin and placebo + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|21.96||||0.0263||95.0|2.04|41.87|||ANCOVA|||Change in HOMA-B from baseline to 26 weeks of treatment was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.||41.87|2.04|0.0263
72555297|NCT00318461|144642201|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.2 mg + metformin and glimepirde + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|-4.36||||0.9227||95.0|-20.94|12.22|||ANCOVA|||Change in HOMA-B from baseline to 26 weeks of treatment was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.||12.22|-20.94|0.9227
72372960|NCT01578850|144256601|SUPERIORITY_OR_OTHER||Difference in Proportions|26.3|||<|0.001|TWO_SIDED|95.0|16.78|35.81|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).|Participants who took rescue therapy had the final value taken before rescue used for analysis at all ensuing time points.|||35.81|16.78|<0.001
72372961|NCT01578850|144256602|SUPERIORITY_OR_OTHER||Difference in proportions|23.7||||0.019|TWO_SIDED|95.0|6.83|40.61|||Cochran-Mantel-Haenszel|The p-value from CMH test of general association was stratified by geographic region.||||40.61|6.83|0.019
72372962|NCT01578850|144256604|SUPERIORITY_OR_OTHER||Difference in proportions|-0.6||||0.371|TWO_SIDED|95.0|-1.76|0.57|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||DAS28-ESR Baseline||0.57|-1.76|0.371
72372963|NCT01578850|144256604|SUPERIORITY_OR_OTHER||Difference in proportions|0.6||||0.358|TWO_SIDED|95.0|-0.59|1.81|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||DAS28-CRP Baseline||1.81|-0.59|0.358
72372964|NCT01578850|144256604|SUPERIORITY_OR_OTHER||Difference in proportions|2.6||||0.667|TWO_SIDED|95.0|-4.76|9.98|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||DAS28-CRP Week 24||9.98|-4.76|0.667
72372965|NCT01578850|144256604|SUPERIORITY_OR_OTHER||Difference in proportions|21.5||||0.001|TWO_SIDED|95.0|10.99|32.02|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||DAS28-ESR Week 28||32.02|10.99|0.001
72372966|NCT01578850|144256604|SUPERIORITY_OR_OTHER||Difference in proportions|19.0||||0.004|TWO_SIDED|95.0|8.81|29.1|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||DAS28-CRP Week 28||29.10|8.81|0.004
72372967|NCT01578850|144256604|SUPERIORITY_OR_OTHER||Difference in proportions|30.8|||<|0.001|TWO_SIDED|95.0|20.79|40.83|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||DAS28-ESR Week 36||40.83|20.79|<0.001
72372968|NCT01578850|144256604|SUPERIORITY_OR_OTHER||Difference in proportions|27.2|||<|0.001|TWO_SIDED|95.0|16.89|37.54|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||DAS28-CRP Week 36||37.54|16.89|<0.001
72372969|NCT01578850|144256604|SUPERIORITY_OR_OTHER||Difference in proportions|31.3|||<|0.001|TWO_SIDED|95.0|21.51|41.08|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||DAS28-ESR Week 44||41.08|21.51|<0.001
72555298|NCT00318461|144642201|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 0.6 mg + metformin and placebo + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|22.08||||0.0253||95.0|2.15|42.01|||ANCOVA|||Change in HOMA-B from baseline to 26 weeks of treatment was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.||42.01|2.15|0.0253
72555299|NCT00318461|144642201|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 0.6 mg + metformin and glimepirde + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|-4.23||||0.9293||95.0|-20.78|12.31|||ANCOVA|||Change in HOMA-B from baseline to 26 weeks of treatment was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.||12.31|-20.78|0.9293
72555300|NCT00318461|144642202|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg + metformin and placebo + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|25.71||||0.8821||95.0|-69.84|121.26|||ANCOVA|||Change in HOMA-B from baseline to 104 weeks of treatment was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.||121.26|-69.84|0.8821
72555301|NCT00318461|144642202|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg + metformin and glimepiride + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|6.56||||0.9989||95.0|-72.66|85.79|||ANCOVA|||Change in HOMA-B from baseline to 104 weeks of treatment was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.||85.79|-72.66|0.9989
72555302|NCT00318461|144642202|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.2 mg + metformin and placebo + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|35.2||||0.7292||95.0|-60.33|130.72|||ANCOVA|||Change in HOMA-B from baseline to 104 weeks of treatment was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.||130.72|-60.33|0.7292
72555303|NCT00318461|144642202|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.2 mg + metformin and glimepirde + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|16.05||||0.9689||95.0|-63.69|95.79|||ANCOVA|||Change in HOMA-B from baseline to 104 weeks of treatment was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.||95.79|-63.69|0.9689
72555304|NCT00318461|144642202|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 0.6 mg + metformin and placebo + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|72.38||||0.1818||95.0|-23.15|167.9|||ANCOVA|||Change in HOMA-B from baseline to 104 weeks of treatment was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.||167.90|-23.15|0.1818
72432535|NCT00783692|144377702|SUPERIORITY_OR_OTHER|||||||0.9288||||||Wilcoxon Rank Sum test on the CRP change from baseline values (two-sided).|Wilcoxon (Mann-Whitney)|||If at least 1 of the primary endpoints was significant, the sequential Hochberg procedure was to be used to test the secondary endpoint for significance at the 0.05% level.||||0.9288
72555305|NCT00318461|144642202|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 0.6 mg + metformin and glimepirde + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|53.23||||0.2978||95.0|-26.3|132.76|||ANCOVA|||Change in HOMA-B from baseline to 104 weeks of treatment was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.||132.76|-26.30|0.2978
72555306|NCT04134091|144642205|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
72555307|NCT04134091|144642205|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
72555308|NCT04134091|144642206|SUPERIORITY|||||||0.0001|||||||ANCOVA|||||||0.0001
72555309|NCT04134091|144642206|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
72555310|NCT04134091|144642207|SUPERIORITY||||||<|0.05|||||||Fisher Exact|||||||<0.05
72555311|NCT04134091|144642207|SUPERIORITY||||||<|0.01|||||||Fisher Exact|||||||<0.01
72555312|NCT04134091|144642208|SUPERIORITY||||||<|0.05|||||||Fisher Exact|||||||<0.05
72555313|NCT04134091|144642208|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||<0.001
72555314|NCT04134091|144642209|SUPERIORITY||||||<|0.05|||||||Fisher Exact|||||||<0.05
72555315|NCT04134091|144642209|SUPERIORITY||||||<|0.05|||||||Fisher Exact|||||||<0.05
72555316|NCT04134091|144642210|SUPERIORITY||||||>|0.05|||||||ANCOVA|||Outcome Variable: Hepatocyte Ballooning Score||||>0.05
72555317|NCT04134091|144642210|SUPERIORITY||||||<|0.05|||||||ANCOVA|||Outcome Variable: Hepatocyte Ballooning Score||||<0.05
72555318|NCT04134091|144642210|SUPERIORITY||||||>|0.05|||||||ANCOVA|||Outcome Variable: Lobular Inflammation Score||||>0.05
72555319|NCT04134091|144642210|SUPERIORITY||||||>|0.05|||||||ANCOVA|||Outcome Variable: Lobular Inflammation Score||||>0.05
72372970|NCT01578850|144256604|SUPERIORITY_OR_OTHER||Difference in proportions|30.2|||<|0.001|TWO_SIDED|95.0|19.95|40.47|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||DAS28-CRP Week 44||40.47|19.95|<0.001
72372971|NCT01578850|144256604|SUPERIORITY_OR_OTHER||Difference in proportions|26.3|||<|0.001|TWO_SIDED|95.0|16.78|35.81|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||DAS28-ESR Week 52||35.81|16.78|<0.001
72372972|NCT01578850|144256604|SUPERIORITY_OR_OTHER||Difference in proportions|27.1|||<|0.001|TWO_SIDED|95.0|16.67|37.47|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||DAS28-CRP Week 52||37.47|16.67|<0.001
72372973|NCT01578850|144256606|SUPERIORITY_OR_OTHER||Difference in proportions|1.3||||0.774|TWO_SIDED|95.0|-9.03|11.68|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||DAS28-CRP Week 24||11.68|-9.03|0.774
72372974|NCT01578850|144256606|SUPERIORITY_OR_OTHER||Difference in proportions|12.3||||0.034|TWO_SIDED|95.0|2.86|21.69|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||DAS28-ESR Week 28||21.69|2.86|0.034
72372975|NCT01578850|144256606|SUPERIORITY_OR_OTHER||Difference in proportions|16.9||||0.02|TWO_SIDED|95.0|6.33|27.54|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||DAS28-CRP Week 28||27.54|6.33|0.020
72372976|NCT01578850|144256606|SUPERIORITY_OR_OTHER||Difference in proportions|14.6||||0.007|TWO_SIDED|95.0|5.48|23.8|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||DAS28-ESR Week 36||23.80|5.48|0.007
72372977|NCT01578850|144256606|SUPERIORITY_OR_OTHER||Difference in proportions|24.9|||<|0.001|TWO_SIDED|95.0|14.72|34.98|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||DAS28-CRP Week 36||34.98|14.72|<0.001
72372978|NCT01578850|144256606|SUPERIORITY_OR_OTHER||Difference in proportions|18.8|||<|0.001|TWO_SIDED|95.0|10.16|27.38|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||DAS28-ESR Week 44||27.38|10.16|<0.001
72372979|NCT01578850|144256606|SUPERIORITY_OR_OTHER||Difference in proportions|30.9|||<|0.001|TWO_SIDED|95.0|21.03|40.76|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||DAS28-CRP Week 44||40.76|21.03|<0.001
72372980|NCT01578850|144256606|SUPERIORITY_OR_OTHER||Difference in proportions|20.6|||<|0.001|TWO_SIDED|95.0|11.78|29.52|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||DAS28-ESR Week 52||29.52|11.78|<0.001
72372981|NCT01578850|144256606|SUPERIORITY_OR_OTHER||Difference in proportions|27.2|||<|0.001|TWO_SIDED|95.0|17.38|36.93|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||DAS28-CRP Week 52||36.93|17.38|<0.001
72372982|NCT01578850|144256608|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.47|||<|0.001|TWO_SIDED|95.0|-0.73|-0.2|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||DAS28-ESR Week 28||-0.20|-0.73|<0.001
72372983|NCT01578850|144256608|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.36||||0.006|TWO_SIDED|95.0|-0.61|-0.11|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||DAS28-CRP Week 28||-0.11|-0.61|0.006
72372984|NCT01578850|144256608|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.68|||<|0.001|TWO_SIDED|95.0|-0.96|-0.39|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||DAS28-ESR Week 36||-0.39|-0.96|<0.001
72372985|NCT01578850|144256608|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.55|||<|0.001|TWO_SIDED|95.0|-0.82|-0.28|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||DAS28-CRP Week 36||-0.28|-0.82|<0.001
72372986|NCT01578850|144256608|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.75|||<|0.001|TWO_SIDED|95.0|-1.03|-0.46|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||DAS28-ESR Week 44||-0.46|-1.03|<0.001
72372987|NCT01578850|144256608|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.65|||<|0.001|TWO_SIDED|95.0|-0.92|-0.37|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||DAS28-CRP Week 44||-0.37|-0.92|<0.001
72372988|NCT01578850|144256608|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.69|||<|0.001|TWO_SIDED|95.0|-0.98|-0.4|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||DAS28-ESR Week 52||-0.40|-0.98|<0.001
72372989|NCT01578850|144256608|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.64|||<|0.001|TWO_SIDED|95.0|-0.91|-0.36|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||DAS28-CRP Week 52||-0.36|-0.91|<0.001
72493647|NCT03048422|144516478|SUPERIORITY||Mean Difference (Final Values)|3.8||||0.18|TWO_SIDED|95.0|-1.8|9.3|||t-test, 2 sided|||Null hypothesis of no difference between arms at delivery (DTG+FTC/TAF - EFV/FTC/TDF).||9.3|-1.8|0.18
72372990|NCT01578850|144256609|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Log Rank|||||||<0.001
72372991|NCT01578850|144256611|SUPERIORITY_OR_OTHER||Difference in proportions|1.4||||0.961|TWO_SIDED|95.0|-6.13|8.9|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||Good Response: DAS28-CRP Week 24||8.90|-6.13|0.961
72555320|NCT04134091|144642210|SUPERIORITY||||||<|0.01|||||||ANCOVA|||Outcome Variable: Steatosis Score||||<0.01
72372992|NCT01578850|144256611|SUPERIORITY_OR_OTHER||Difference in proportions|21.5||||0.001|TWO_SIDED|95.0|10.99|32.02|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||Good Response: DAS28-ESR Week 28||32.02|10.99|0.001
72372993|NCT01578850|144256611|SUPERIORITY_OR_OTHER||Difference in proportions|18.3||||0.007|TWO_SIDED|95.0|8.08|28.53|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||Good Response: DAS28-CRP Week 28||28.53|8.08|0.007
72372994|NCT01578850|144256611|SUPERIORITY_OR_OTHER||Difference in proportions|31.4|||<|0.001|TWO_SIDED|95.0|21.42|41.39|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||Good Response: DAS28-ESR Week 36||41.39|21.42|<0.001
72372995|NCT01578850|144256611|SUPERIORITY_OR_OTHER||Difference in proportions|27.2|||<|0.001|TWO_SIDED|95.0|16.83|37.54|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||Good Response: DAS28-CRP Week 36||37.54|16.83|<0.001
72372996|NCT01578850|144256611|SUPERIORITY_OR_OTHER||Difference in proportions|31.3|||<|0.001|TWO_SIDED|95.0|21.53|41.02|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||Good Response: DAS28-ESR Week 44||41.02|21.53|<0.001
72372997|NCT01578850|144256611|SUPERIORITY_OR_OTHER||Difference in proportions|30.8|||<|0.001|TWO_SIDED|95.0|20.54|41.05|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||Good Response: DAS28-CRP Week 44||41.05|20.54|<0.001
72372998|NCT01578850|144256611|SUPERIORITY_OR_OTHER||Difference in proportions|26.3|||<|0.001|TWO_SIDED|95.0|16.82|35.74|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||Good Response: DAS28-ESR Week 52||35.74|16.82|<0.001
72372999|NCT01578850|144256611|SUPERIORITY_OR_OTHER||Difference in proportions|27.0|||<|0.001|TWO_SIDED|95.0|16.63|37.44|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||Good Response: DAS28-CRP Week 52||37.44|16.63|<0.001
72373000|NCT01578850|144256611|SUPERIORITY_OR_OTHER||Difference in Proportions|0.0||||0.766|TWO_SIDED|95.0|-1.69|1.65|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||Good Response: DAS28-ESR Week 24||1.65|-1.69|0.766
72373001|NCT01578850|144256611|SUPERIORITY_OR_OTHER||Difference in Proportions|8.2||||0.091|TWO_SIDED|95.0|2.32|14.1|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||Moderate Response: DAS28-ESR Week 28||14.10|2.32|0.091
72373002|NCT01578850|144256611|SUPERIORITY_OR_OTHER||Difference in proportions|6.5||||0.227|TWO_SIDED|95.0|1.28|11.75|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||Moderate Response: DAS28-CRP Week 28||11.75|1.28|0.227
72493648|NCT03048422|144516478|SUPERIORITY||Mean Difference (Final Values)|11.1||||0.27|TWO_SIDED|95.0|-8.9|31.1|||t-test, 2 sided|||Null hypothesis of no difference between arms at week 26 (DTG+FTC/TAF - DTG+FTC/TDF).||31.1|-8.9|0.27
72493649|NCT03048422|144516478|SUPERIORITY||Mean Difference (Final Values)|-11.4||||0.048|TWO_SIDED|95.0|-22.6|-0.1|||t-test, 2 sided|||Null hypothesis of no difference between arms at week 26 (DTG+FTC/TDF - EFV/FTC/TDF).||-0.1|-22.6|0.048
72493650|NCT03048422|144516478|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.98|TWO_SIDED|95.0|-21.0|20.5|||t-test, 2 sided|||Null hypothesis of no difference between arms at week 26 (DTG+FTC/TAF - EFV/FTC/TDF).||20.5|-21.0|0.98
72373003|NCT01578850|144256611|SUPERIORITY_OR_OTHER||Difference in proportions|9.9||||0.072|TWO_SIDED|95.0|3.27|16.6|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||Moderate Response: DAS28-ESR Week 36||16.60|3.27|0.072
72373004|NCT01578850|144256611|SUPERIORITY_OR_OTHER||Difference in proportions|8.8||||0.108|TWO_SIDED|95.0|2.43|15.2|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||Moderate Response: DAS28-CRP Week 36||15.20|2.43|0.108
72373005|NCT01578850|144256611|SUPERIORITY_OR_OTHER||Difference in proportions|11.7||||0.035|TWO_SIDED|95.0|4.69|18.72|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||Moderate Response: DAS28-ESR Week 44||18.72|4.69|0.035
72373006|NCT01578850|144256611|SUPERIORITY_OR_OTHER||Difference in proportions|10.6||||0.03|TWO_SIDED|95.0|4.2|17.06|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||Moderate Response: DAS28-ESR Week 44||17.06|4.20|0.030
72373007|NCT01578850|144256611|SUPERIORITY_OR_OTHER||Difference in proportions|11.1||||0.048|TWO_SIDED|95.0|4.15|18.06|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||Moderate Response: DAS28-ESR Week 52||18.06|4.15|0.048
72373008|NCT01578850|144256611|SUPERIORITY_OR_OTHER||Difference in proportions|11.2||||0.016|TWO_SIDED|95.0|4.92|17.58|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||Moderate Response: DAS28-CRP Week 52||17.58|4.92|0.016
72373009|NCT01578850|144256613|SUPERIORITY_OR_OTHER||Difference in proportions|0.6||||0.358|TWO_SIDED|95.0|-0.59|1.81|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||CDAI: LDA Baseline||1.81|-0.59|0.358
72373010|NCT01578850|144256613|SUPERIORITY_OR_OTHER||Difference in proportions|3.4||||0.341|TWO_SIDED|95.0|-2.38|9.16|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||CDAI: LDA: Week 24||9.16|-2.38|0.341
72493651|NCT03048422|144516479|SUPERIORITY||Risk Difference (RD)|-0.9||||0.4|TWO_SIDED|95.0|-3.1|1.3|||Wald test of two proportions|||Null hypothesis of no difference between groups (DTG+FTC/TAF - DTG+FTC/TDF).||1.3|-3.1|0.40
72373011|NCT01578850|144256613|SUPERIORITY_OR_OTHER||Difference in proportions|18.3||||0.004|TWO_SIDED|95.0|8.4|28.27|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||CDAI: LDA: Week 28||28.27|8.40|0.004
72373012|NCT01578850|144256613|SUPERIORITY_OR_OTHER||Difference in proportions|24.1|||<|0.001|TWO_SIDED|95.0|13.88|34.4|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||CDAI: LDA: Week 36||34.40|13.88|<0.001
72373013|NCT01578850|144256613|SUPERIORITY_OR_OTHER||Difference in proportions|27.1|||<|0.001|TWO_SIDED|95.0|16.85|37.35|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||CDAI: LDA: Week 44||37.35|16.85|<0.001
72373014|NCT01578850|144256613|SUPERIORITY_OR_OTHER||Difference in proportions|24.0|||<|0.001|TWO_SIDED|95.0|13.61|34.42|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||CDAI: LDA: Week 52||34.42|13.61|<0.001
72373015|NCT01578850|144256613|SUPERIORITY_OR_OTHER||Difference in proportions|2.3||||0.774|TWO_SIDED|95.0|-5.5|10.06|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||CDAI: Remission: Week 24||10.06|-5.50|0.774
72373016|NCT01578850|144256613|SUPERIORITY_OR_OTHER||Difference in proportions|0.4||||0.645|TWO_SIDED|95.0|-7.15|8.03|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||CDAI: Remission: Week 28||8.03|-7.15|0.645
72373017|NCT01578850|144256613|SUPERIORITY_OR_OTHER||Difference in proportions|8.4||||0.08|TWO_SIDED|95.0|0.36|16.35|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||CDAI: Remission: Week 36||16.35|0.36|0.080
72373018|NCT01578850|144256613|SUPERIORITY_OR_OTHER||Difference in proportions|9.6||||0.025|TWO_SIDED|95.0|1.49|17.68|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||CDAI: Remission: Week 44||17.68|1.49|0.025
72373019|NCT01578850|144256613|SUPERIORITY_OR_OTHER||Difference in proportions|9.0||||0.088|TWO_SIDED|95.0|1.02|16.88|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||CDAI: Remission: Week 52||16.88|1.02|0.088
72373020|NCT01578850|144256613|SUPERIORITY_OR_OTHER||Difference in proportions|0.6||||0.358|TWO_SIDED|95.0|-0.59|1.81|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||SDAI: LDA: Baseline||1.81|-0.59|0.358
72373021|NCT01578850|144256613|SUPERIORITY_OR_OTHER||Difference in proportions|3.3||||0.258|TWO_SIDED|95.0|-3.57|10.13|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||SDAI: LDA: Week 24||10.13|-3.57|0.258
72373022|NCT01578850|144256613|SUPERIORITY_OR_OTHER||Difference in proportions|17.7||||0.005|TWO_SIDED|95.0|7.49|27.92|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||SDAI: LDA: Week 28||27.92|7.49|0.005
72373023|NCT01578850|144256613|SUPERIORITY_OR_OTHER||Difference in proportions|27.2|||<|0.001|TWO_SIDED|95.0|16.93|37.55|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||SDAI: LDA: Week 36||37.55|16.93|<0.001
72373024|NCT01578850|144256613|SUPERIORITY_OR_OTHER||Difference in proportions|32.0|||<|0.001|TWO_SIDED|95.0|21.83|42.23|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||SDAI: LDA: Week 44||42.23|21.83|<0.001
72373025|NCT01578850|144256613|SUPERIORITY_OR_OTHER||Difference in proportions|28.3|||<|0.001|TWO_SIDED|95.0|18.0|38.69|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||SDAI: LDA: Week 52||38.69|18.00|<0.001
72373026|NCT01578850|144256613|SUPERIORITY_OR_OTHER||Difference in proportions|3.0||||0.672|TWO_SIDED|95.0|-5.51|11.51|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||SDAI: Remission: Week 24||11.51|-5.51|0.672
72373027|NCT01578850|144256613|SUPERIORITY_OR_OTHER||Difference in proportions|0.0||||0.556|TWO_SIDED|95.0|-8.03|8.0|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||SDAI: Remission: Week 28||8.00|-8.03|0.556
72373028|NCT01578850|144256613|SUPERIORITY_OR_OTHER||Difference in proportions|10.3||||0.022|TWO_SIDED|95.0|2.07|18.45|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||SDAI: Remission: Week 36||18.45|2.07|0.022
72373029|NCT01578850|144256613|SUPERIORITY_OR_OTHER||Difference in proportions|9.0||||0.047|TWO_SIDED|95.0|0.85|17.25|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||SDAI: Remission: Week 44||17.25|0.85|0.047
72373030|NCT01578850|144256613|SUPERIORITY_OR_OTHER||Difference in proportions|12.1||||0.031|TWO_SIDED|95.0|3.7|20.57|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||SDAI: Remission: Week 52||20.57|3.70|0.031
72373031|NCT01578850|144256615|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.1||||0.049|TWO_SIDED|95.0|-4.19|-0.01|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||CDAI: Week 28||-0.01|-4.19|0.049
72555321|NCT04134091|144642210|SUPERIORITY||||||<|0.001|||||||ANCOVA|||Outcome Variable: Steatosis Score||||<0.001
72373032|NCT01578850|144256615|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.38||||0.005|TWO_SIDED|95.0|-5.72|-1.05|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||CDAI: Week 36||-1.05|-5.72|0.005
72555322|NCT04134091|144642211|SUPERIORITY||||||>|0.05|||||||Fisher Exact|||||||>0.05
72555323|NCT04134091|144642211|SUPERIORITY||||||>|0.05|||||||Fisher Exact|||||||>0.05
72555324|NCT04134091|144642212|SUPERIORITY||||||>|0.05|||||||Fisher Exact|||||||>0.05
72555325|NCT04134091|144642212|SUPERIORITY||||||>|0.05|||||||Fisher Exact|||||||>0.05
72432536|NCT00783692|144377703|SUPERIORITY_OR_OTHER||Risk Difference (RD)|13.4||||0.0132|TWO_SIDED|95.0|2.8|24.0||CMH chi-square test, stratified by: 1) concomitant use of oral corticosteroids (yes/no); 2) previous exposure to TNFα antagonists and/or concomitant immunomodulator use (yes/no); 3) enrollment in Cohort 1 or Cohort 2 in the Induction Phase.|Cochran-Mantel-Haenszel||Risk Difference = adjusted (for stratification factors) percent vedolizumab - adjusted percent placebo|To maintain the overall Type I error rate at 5% in the multiple-dose comparisons in each key secondary endpoint, the Hochberg method was used. To further maintain the overall Type I error rate at 5%, the key secondary assessments were performed sequentially. The first key secondary endpoint was tested only if 1 or both of the primary comparisons were significant and the next key secondary endpoint was to be tested only if the previous key secondary endpoint was significant for at least 1 dose.||24.0|2.8|0.0132
72432537|NCT00783692|144377703|SUPERIORITY_OR_OTHER||Risk Difference (RD)|15.3||||0.0053|TWO_SIDED|95.0|4.6|26.0||CMH chi-square test, stratified by: 1) concomitant use of oral corticosteroids (yes/no); 2) previous exposure to TNFα antagonists and/or concomitant immunomodulator use (yes/no); 3) enrollment in Cohort 1 or Cohort 2 in the Induction Phase.|Cochran-Mantel-Haenszel||Risk Difference = adjusted (for stratification factors) percent vedolizumab - adjusted percent placebo|To maintain the overall Type I error rate at 5% in the multiple-dose comparisons in each key secondary endpoint, the Hochberg method was used. To further maintain the overall Type I error rate at 5%, the key secondary assessments were performed sequentially. The first key secondary endpoint was tested only if 1 or both of the primary comparisons were significant and the next key secondary endpoint was to be tested only if the previous key secondary endpoint was significant for at least 1 dose.||26.0|4.6|0.0053
72555326|NCT04134091|144642213|SUPERIORITY||||||<|0.05|||||||Fisher Exact|||||||<0.05
72555327|NCT04134091|144642213|SUPERIORITY||||||>|0.05|||||||Fisher Exact|||||||>0.05
72555328|NCT04134091|144642214|SUPERIORITY||||||<|0.05|||||||ANCOVA|||||||<0.05
72373033|NCT01578850|144256615|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.02|||<|0.001|TWO_SIDED|95.0|-6.37|-1.67|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||CDAI: Week 44||-1.67|-6.37|<0.001
72555329|NCT04134091|144642214|SUPERIORITY||||||>|0.05|||||||ANCOVA|||||||>0.05
72555330|NCT04134091|144642215|SUPERIORITY||||||>|0.05|||||||ANCOVA|||||||>0.05
72555331|NCT04134091|144642215|SUPERIORITY||||||<|0.05|||||||ANCOVA|||||||<0.05
72555332|NCT04134091|144642216|SUPERIORITY||||||>|0.05|||||||Mixed Models Analysis|||Outcome Variable: AST||||>0.05
72555333|NCT04134091|144642216|SUPERIORITY||||||<|0.01|||||||Mixed Models Analysis|||Outcome Variable: AST||||<0.01
72555334|NCT04134091|144642216|SUPERIORITY||||||>|0.05|||||||Mixed Models Analysis|||Outcome Variable: ALT||||>0.05
72555335|NCT04134091|144642216|SUPERIORITY||||||<|0.01|||||||Mixed Models Analysis|||Outcome Variable: ALT||||< 0.01
72555336|NCT04134091|144642216|SUPERIORITY||||||>|0.05|||||||Mixed Models Analysis|||Outcome Variable: ALP||||>0.05
72555337|NCT04134091|144642216|SUPERIORITY||||||<|0.05|||||||Mixed Models Analysis|||Outcome Variable: ALP||||<0.05
72555338|NCT04134091|144642216|SUPERIORITY||||||>|0.05|||||||Mixed Models Analysis|||Outcome Variable: GGT||||>0.05
72555339|NCT04134091|144642216|SUPERIORITY||||||<|0.05|||||||Mixed Models Analysis|||Outcome Variable: GGT||||<0.05
72555340|NCT04134091|144642217|SUPERIORITY||||||>|0.05|||||||Mixed Models Analysis|||Outcome Variable: Total cholesterol||||>0.05
72555341|NCT04134091|144642217|SUPERIORITY||||||>|0.05|||||||Mixed Models Analysis|||Outcome Variable: Total cholesterol||||>0.05
72555342|NCT04134091|144642217|SUPERIORITY||||||>|0.05|||||||Mixed Models Analysis|||Outcome Variable: LDL||||>0.05
72555343|NCT04134091|144642217|SUPERIORITY||||||>|0.05|||||||Mixed Models Analysis|||Outcome Variable: LDL||||>0.05
72555344|NCT04134091|144642217|SUPERIORITY||||||>|0.05|||||||Mixed Models Analysis|||Outcome Variable: HDL||||>0.05
72373034|NCT01578850|144256615|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.02|||<|0.001|TWO_SIDED|95.0|-6.36|-1.68|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||CDAI: Week 52||-1.68|-6.36|<0.001
72555345|NCT04134091|144642217|SUPERIORITY||||||>|0.05|||||||Mixed Models Analysis|||Outcome Variable: HDL||||>0.05
72555346|NCT04134091|144642217|SUPERIORITY||||||>|0.05|||||||Mixed Models Analysis|||Outcome Variable: triglycerides||||>0.05
72555347|NCT04134091|144642217|SUPERIORITY||||||>|0.05|||||||Mixed Models Analysis|||Outcome Variable: triglycerides||||>0.05
72555348|NCT01929863|144642237|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-28.13|||||TWO_SIDED|95.0|-50.4|-5.86|||||The point estimate was calculated as least square mean difference (net values) of Treatment A-GSK2330672 + Metformin and Treatment B-Placebo + Metformin for Fasting Value.|Treatment A-GSK2330672 + Metformin versus Treatment B-Placebo + Metformin for Fasting Value.||-5.86|-50.40|
72555349|NCT01929863|144642237|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-29.16|||||TWO_SIDED|95.0|-51.68|-6.64|||||The point estimate was calculated as least square mean difference (net values) of Treatment A-GSK2330672 + Metformin and Treatment B-Placebo + Metformin for Maximum (0-4 h) Value.|Treatment A-GSK2330672 + Metformin versus Treatment B-Placebo + Metformin for Maximum (0-4 h) Value.||-6.64|-51.68|
72555350|NCT01929863|144642237|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-36.58|||||TWO_SIDED|95.0|-62.25|-10.9|||||The point estimate was calculated as least square mean difference (net values) of Treatment A-GSK2330672 + Metformin and Treatment B-Placebo + Metformin for Maximum (4-10 h) Value.|Treatment A-GSK2330672 + Metformin versus Treatment B-Placebo + Metformin for Maximum (4-10 h) Value.||-10.90|-62.25|
72432538|NCT00783692|144377704|SUPERIORITY_OR_OTHER||Risk Difference (RD)|15.9||||0.0154|TWO_SIDED|95.0|3.0|28.7||P-value is based on the CMH chi-square test, with stratification according to: 1) previous exposure to TNFα antagonists and/or concomitant immunomodulator use (yes/no); 2) enrollment in Cohort 1 or Cohort 2 in the Induction Phase.|Cochran-Mantel-Haenszel||Risk Difference = adjusted (for stratification factors) percent vedolizumab - adjusted percent placebo|To maintain the overall Type I error rate at 5% in the multiple-dose comparisons in each key secondary endpoint, the Hochberg method was used. To further maintain the overall Type I error rate at 5%, the key secondary assessments were performed sequentially. The first key secondary endpoint was tested only if 1 or both of the primary comparisons were significant and the next key secondary endpoint was to be tested only if the previous key secondary endpoint was significant for at least 1 dose.||28.7|3.0|0.0154
72432539|NCT00783692|144377704|SUPERIORITY_OR_OTHER||Risk Difference (RD)|12.9||||0.045|TWO_SIDED|95.0|0.3|25.5||P-value is based on the CMH chi-square test, with stratification according to: 1) previous exposure to TNFα antagonists and/or concomitant immunomodulator use (yes/no); 2) enrollment in Cohort 1 or Cohort 2 in the Induction Phase.|Cochran-Mantel-Haenszel||Risk Difference = adjusted (for stratification factors) percent vedolizumab - adjusted percent placebo|To maintain the overall Type I error rate at 5% in the multiple-dose comparisons in each key secondary endpoint, the Hochberg method was used. To further maintain the overall Type I error rate at 5%, the key secondary assessments were performed sequentially. The first key secondary endpoint was tested only if 1 or both of the primary comparisons were significant and the next key secondary endpoint was to be tested only if the previous key secondary endpoint was significant for at least 1 dose.||25.5|0.3|0.0450
72373035|NCT01578850|144256615|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.22||||0.047|TWO_SIDED|95.0|-4.4|-0.03|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||SDAI: Week 28||-0.03|-4.40|0.047
72432540|NCT00783692|144377705|SUPERIORITY_OR_OTHER||Risk Difference (RD)|7.2||||0.1036|TWO_SIDED|95.0|-1.5|16.0||CMH chi-square test, stratified by: 1) concomitant use of oral corticosteroids (yes/no); 2) previous exposure to TNFα antagonists and/or concomitant immunomodulator use (yes/no); 3) enrollment in Cohort 1 or Cohort 2 in the Induction Phase.|Cochran-Mantel-Haenszel||Risk Difference = adjusted (for stratification factors) percent vedolizumab - adjusted percent placebo|To maintain the overall Type I error rate at 5% in the multiple-dose comparisons in each key secondary endpoint, the Hochberg method was used. To further maintain the overall Type I error rate at 5%, the key secondary assessments were performed sequentially. The first key secondary endpoint was tested only if 1 or both of the primary comparisons were significant and the next key secondary endpoint was to be tested only if the previous key secondary endpoint was significant for at least 1 dose.||16.0|-1.5|0.1036
72432541|NCT00783692|144377705|SUPERIORITY_OR_OTHER||Risk Difference (RD)|2.0||||0.6413|TWO_SIDED|95.0|-6.3|10.2||CMH chi-square test, stratified by: 1) concomitant use of oral corticosteroids (yes/no); 2) previous exposure to TNFα antagonists and/or concomitant immunomodulator use (yes/no); 3) enrollment in Cohort 1 or Cohort 2 in the Induction Phase.|Cochran-Mantel-Haenszel||Risk Difference = adjusted (for stratification factors) percent vedolizumab - adjusted percent placebo|To maintain the overall Type I error rate at 5% in the multiple-dose comparisons in each key secondary endpoint, the Hochberg method was used. To further maintain the overall Type I error rate at 5%, the key secondary assessments were performed sequentially. The first key secondary endpoint was tested only if 1 or both of the primary comparisons were significant and the next key secondary endpoint was to be tested only if the previous key secondary endpoint was significant for at least 1 dose.||10.2|-6.3|0.6413
72432542|NCT05550337|144377724|EQUIVALENCE|The 90% CI for the Test-to-Reference ratio of LS mean percent reduction from Baseline to Week 12/Day 84, in the inflammatory lesion counts to be contained within (0.80, 1.25).|Mean Difference (Net)|0.998|||||TWO_SIDED|90.0|0.927|1.076||||||||1.076|0.927|
72432543|NCT05550337|144377725|EQUIVALENCE|The 90% CI for the Test-to-Reference ratio of LS mean percent reduction from Baseline to Week 12/Day 84, in the non-inflammatory lesion counts to be contained within (0.80, 1.25).|Mean Difference (Net)|1.116|||||TWO_SIDED|90.0|1.017|1.228||||||||1.228|1.017|
72432544|NCT02266329|144377742|SUPERIORITY||Mean Difference (Net)|-3.9|STANDARD_ERROR_OF_MEAN|1.6||0.034|TWO_SIDED|95.0|-6.9|-0.8||The significance of the study visit by treatment interaction with study visit coded as baseline, 4 weeks, 8 weeks, and 12 weeks.|Mixed Models Analysis|||Change from baseline in headache (HA) frequency (1. Primary Outcome Measure) is based on linear mixed effects regression of outcome on study visit by treatment interaction with study participant as a random effect.||-0.8|-6.9|0.034
72432545|NCT02501811|144377762|SUPERIORITY||Mean Difference (Final Values)|-0.08|STANDARD_ERROR_OF_MEAN|1.05||0.993|TWO_SIDED|95.0|-2.19|2.023|||ANCOVA|The change in LVEF was compared using ANCOVA analyses adjusting for baseline values|Confidence intervals based on t-test|||2.023|-2.190|0.993
72432546|NCT02501811|144377762|SUPERIORITY||Mean Difference (Final Values)|0.7|STANDARD_ERROR_OF_MEAN|0.96||0.499|TWO_SIDED|95.0|-1.229|2.635|||ANCOVA|The change in LVEF was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t-test|||2.635|-1.229|0.499
72432547|NCT02501811|144377762|SUPERIORITY||Mean Difference (Final Values)|1.38|STANDARD_ERROR_OF_MEAN|1.05||0.578|TWO_SIDED|95.0|-0.729|3.485|||ANCOVA|The change in LVEF was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t-test|||3.485|-0.729|0.578
72373036|NCT01578850|144256615|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.54||||0.004|TWO_SIDED|95.0|-5.97|-1.12|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||SDAI: Week 36||-1.12|-5.97|0.004
72432548|NCT02501811|144377762|SUPERIORITY||Mean Difference (Final Values)|-1.46|STANDARD_ERROR_OF_MEAN|1.04||0.523|TWO_SIDED|95.0|-3.552|0.629|||ANCOVA|The change in LVEF was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t-test|||0.629|-3.552|0.523
72432549|NCT02501811|144377762|SUPERIORITY||Mean Difference (Final Values)|-0.79|STANDARD_ERROR_OF_MEAN|0.95||0.471|TWO_SIDED|95.0|-2.7|1.127|||ANCOVA|The change in LVEF was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t-test|||1.127|-2.7|0.471
72432550|NCT02501811|144377762|SUPERIORITY||Mean Difference (Final Values)|0.67|STANDARD_ERROR_OF_MEAN|0.95||0.485|TWO_SIDED|95.0|-1.24|2.59|||ANCOVA|The change in LVEF was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t-test|||2.590|-1.240|0.485
72373037|NCT01578850|144256615|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.33|||<|0.001|TWO_SIDED|95.0|-6.78|-1.88|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||SDAI: Week 44||-1.88|-6.78|<0.001
72373038|NCT01578850|144256615|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.27|||<|0.001|TWO_SIDED|95.0|-6.7|-1.84|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||SDAI: Week 52||-1.84|-6.70|<0.001
72373039|NCT01578850|144256617|SUPERIORITY_OR_OTHER||Difference in proportions|-0.2||||0.742|TWO_SIDED|95.0|-4.21|3.9|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||ACR 20: Week 24||3.90|-4.21|0.742
72373040|NCT01578850|144256617|SUPERIORITY_OR_OTHER||Difference in proportions|9.8||||0.143|TWO_SIDED|95.0|2.45|17.06|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||ACR 20: Week 28||17.06|2.45|0.143
72373041|NCT01578850|144256617|SUPERIORITY_OR_OTHER||Difference in proportions|11.4||||0.111|TWO_SIDED|95.0|3.31|19.51|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||ACR 20: Week 36||19.51|3.31|0.111
72373042|NCT01578850|144256617|SUPERIORITY_OR_OTHER||Difference in proportions|10.1||||0.175|TWO_SIDED|95.0|1.8|18.49|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||ACR 20: Week 44||18.49|1.80|0.175
72373043|NCT01578850|144256617|SUPERIORITY_OR_OTHER||Difference in proportions|10.8||||0.088|TWO_SIDED|95.0|2.49|19.05|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||ACR 20: Week 52||19.05|2.49|0.088
72373044|NCT01578850|144256617|SUPERIORITY_OR_OTHER||Difference in proportions|2.5||||0.584|TWO_SIDED|95.0|-4.78|9.75|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||ACR 50: Week 24||9.75|-4.78|0.584
72373045|NCT01578850|144256617|SUPERIORITY_OR_OTHER||Difference in proportions|11.5||||0.226|TWO_SIDED|95.0|1.59|21.34|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||ACR 50: Week 28||21.34|1.59|0.226
72373046|NCT01578850|144256617|SUPERIORITY_OR_OTHER||Difference in proportions|17.2||||0.012|TWO_SIDED|95.0|6.76|27.56|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||ACR 50: Week 36||27.56|6.76|0.012
72373047|NCT01578850|144256617|SUPERIORITY_OR_OTHER||Difference in proportions|19.0||||0.006|TWO_SIDED|95.0|8.59|29.35|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||ACR 50: Week 44||29.35|8.59|0.006
72373048|NCT01578850|144256617|SUPERIORITY_OR_OTHER||Difference in Proportions|17.7||||0.014|TWO_SIDED|95.0|7.3|28.16|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||ACR 50: Week 52||28.16|7.30|0.014
72373049|NCT01578850|144256617|SUPERIORITY_OR_OTHER||Difference in Proportions|-2.7||||0.702|TWO_SIDED|95.0|-13.49|8.11|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||ACR 70: Week 24||8.11|-13.49|0.702
72373050|NCT01578850|144256617|SUPERIORITY_OR_OTHER||Difference in proportions|7.1||||0.378|TWO_SIDED|95.0|-3.37|17.5|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||ACR 70: Week 28||17.50|-3.37|0.378
72373051|NCT01578850|144256617|SUPERIORITY_OR_OTHER||Difference in proportions|17.3||||0.004|TWO_SIDED|95.0|7.12|27.56|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||ACR 70: Week 36||27.56|7.12|0.004
72373052|NCT01578850|144256617|SUPERIORITY_OR_OTHER||Difference in proportions|18.5||||0.001|TWO_SIDED|95.0|8.4|28.55|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||ACR 70: Week 44||28.55|8.40|0.001
72373053|NCT01578850|144256617|SUPERIORITY_OR_OTHER||Difference in proportions|16.0||||0.005|TWO_SIDED|95.0|5.96|26.02|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||ACR 70: Week 52||26.02|5.96|0.005
72373054|NCT01578850|144256617|SUPERIORITY_OR_OTHER||Difference in proportions|-0.3||||0.921|TWO_SIDED|95.0|-6.19|5.67|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||ACR 90: Week 24||5.67|-6.19|0.921
72373055|NCT01578850|144256617|SUPERIORITY_OR_OTHER||Difference in proportions|3.3||||0.41|TWO_SIDED|95.0|-2.19|8.86|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||ACR 90: Week 28||8.86|-2.19|0.410
72373056|NCT01578850|144256617|SUPERIORITY_OR_OTHER||Difference in proportions|6.4||||0.073|TWO_SIDED|95.0|0.41|12.48|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||ACR 90: Week 36||12.48|0.41|0.073
72373057|NCT01578850|144256617|SUPERIORITY_OR_OTHER||Difference in proportions|4.6||||0.219|TWO_SIDED|95.0|-0.97|10.08|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||ACR 90: Week 44||10.08|-0.97|0.219
72432551|NCT02501811|144377763|SUPERIORITY||Mean Difference (Final Values)|-0.26|STANDARD_ERROR_OF_MEAN|1.05||0.942|TWO_SIDED|95.0|-2.406|1.887|||ANCOVA|The change in global circumferential strain was compared using ANCOVA analyses adjusting for baseline values|Confidence intervals based on t-test|||1.887|-2.406|0.942
72432552|NCT02501811|144377763|SUPERIORITY||Mean Difference (Final Values)|0.58|STANDARD_ERROR_OF_MEAN|1.17||0.282|TWO_SIDED|95.0|-1.815|2.975|||ANCOVA|The change in global circumferential strain was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t-test|||2.975|-1.815|0.282
72432553|NCT02501811|144377763|SUPERIORITY||Mean Difference (Final Values)|0.66|STANDARD_ERROR_OF_MEAN|0.95||0.163|TWO_SIDED|95.0|-1.31|2.635|||ANCOVA|The change in global circumferential strain was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t-test|||2.635|-1.310|0.163
72432554|NCT02501811|144377763|SUPERIORITY||Mean Difference (Final Values)|-0.92|STANDARD_ERROR_OF_MEAN|0.77||0.175|TWO_SIDED|95.0|-2.471|0.628|||ANCOVA|The change in global circumferential strain was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t test|||0.628|-2.471|0.175
72432555|NCT02501811|144377763|SUPERIORITY||Mean Difference (Final Values)|-0.84|STANDARD_ERROR_OF_MEAN|1.03||0.329|TWO_SIDED|95.0|-2.932|1.254|||ANCOVA|The change in global circumferential strain was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t test|||1.254|-2.932|0.329
72432556|NCT02501811|144377763|SUPERIORITY||Mean Difference (Final Values)|0.08|STANDARD_ERROR_OF_MEAN|0.93||0.752|TWO_SIDED|95.0|-1.829|1.994|||ANCOVA|The change in global circumferential strain was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t-test|||1.994|-1.829|0.752
72432557|NCT02501811|144377764|SUPERIORITY||Mean Difference (Final Values)|0.4|STANDARD_ERROR_OF_MEAN|0.75||0.733|TWO_SIDED|95.0|-1.118|1.927|||ANCOVA|The change in regional longitudinal strain was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t-test|||1.927|-1.118|0.733
72432558|NCT02501811|144377764|SUPERIORITY||Mean Difference (Final Values)|0.4|STANDARD_ERROR_OF_MEAN|0.81||0.735|TWO_SIDED|95.0|-1.248|2.041|||ANCOVA|The change in regional longitudinal strain was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t test|||2.041|-1.248|0.735
72432559|NCT02501811|144377764|SUPERIORITY||Mean Difference (Final Values)|0.15|STANDARD_ERROR_OF_MEAN|0.8||0.794|TWO_SIDED|95.0|-1.464|1.767|||ANCOVA|The change in regional longitudinal strain was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t test|||1.767|-1.464|0.794
72432560|NCT02501811|144377764|SUPERIORITY||Mean Difference (Final Values)|0.25|STANDARD_ERROR_OF_MEAN|0.7||0.951|TWO_SIDED|95.0|-1.161|1.666|||ANCOVA|The change in regional longitudinal strain was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t test|||1.666|-1.161|0.951
72432561|NCT02501811|144377764|SUPERIORITY||Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.71||0.962|TWO_SIDED|95.0|-1.441|1.457|||ANCOVA|The change in regional longitudinal strain was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t test|||1.457|-1.441|0.962
72432562|NCT02501811|144377764|SUPERIORITY||Mean Difference (Final Values)|-0.24|STANDARD_ERROR_OF_MEAN|0.76||0.945|TWO_SIDED|95.0|-1.793|1.303|||ANCOVA|The change in regional longitudinal strain was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t test|||1.303|-1.793|0.945
72432563|NCT02501811|144377765|SUPERIORITY||Mean Difference (Final Values)|-2.02|STANDARD_ERROR_OF_MEAN|3.85||0.602|TWO_SIDED|95.0|-9.754|5.711|||ANCOVA|The change in LVEDVI was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t test|||5.711|-9.754|0.602
72432564|NCT02501811|144377765|SUPERIORITY||Mean Difference (Final Values)|-2.78|STANDARD_ERROR_OF_MEAN|3.39||0.443|TWO_SIDED|95.0|-9.609|4.044|||ANCOVA|The change in LVEDVI was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t test|||4.044|-9.609|0.443
72432565|NCT02501811|144377765|SUPERIORITY||Mean Difference (Net)|-4.13|STANDARD_ERROR_OF_MEAN|3.42||0.348|TWO_SIDED|95.0|-11.011|2.76|||ANCOVA|The change in LVEDVI was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t test|||2.760|-11.011|0.348
72432566|NCT02501811|144377765|SUPERIORITY||Mean Difference (Final Values)|2.1|STANDARD_ERROR_OF_MEAN|3.92||0.812|TWO_SIDED|95.0|-5.76|9.968|||ANCOVA|The change in LVEDVI was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t test|||9.968|-5.760|0.812
72432567|NCT02501811|144377765|SUPERIORITY||Mean Difference (Final Values)|0.76|STANDARD_ERROR_OF_MEAN|3.89||0.9|TWO_SIDED|95.0|-7.052|8.574|||ANCOVA|The change in LVEDVI was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t test|||8.574|-7.052|0.900
72432568|NCT02501811|144377765|SUPERIORITY||Mean Difference (Final Values)|-1.34|STANDARD_ERROR_OF_MEAN|3.47||0.848|TWO_SIDED|95.0|-8.321|5.635|||ANCOVA|The change in LVEDVI was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t test|||5.635|-8.321|0.848
72432569|NCT02501811|144377766|SUPERIORITY||Mean Difference (Final Values)|-1.25|STANDARD_ERROR_OF_MEAN|3.01||0.659|TWO_SIDED|95.0|-7.281|4.789|||ANCOVA|The change in LVESVI was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t test|||4.789|-7.281|0.659
72432570|NCT02501811|144377766|SUPERIORITY||Mean Difference (Final Values)|-2.46|STANDARD_ERROR_OF_MEAN|3.06||0.466|TWO_SIDED|95.0|-8.621|3.71|||ANCOVA|The change in LVESVI was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t test|||3.710|-8.621|0.466
72432571|NCT02501811|144377766|SUPERIORITY||Mean Difference (Final Values)|-4.6|STANDARD_ERROR_OF_MEAN|3.08||0.293|TWO_SIDED|95.0|-10.799|1.594|||ANCOVA|The change in LVESVI was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t test|||1.594|-10.799|0.293
72432572|NCT02501811|144377766|SUPERIORITY||Mean Difference (Final Values)|3.36|STANDARD_ERROR_OF_MEAN|3.06||0.53|TWO_SIDED|95.0|-2.795|9.508|||ANCOVA|The change in LVESVI was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t test|||9.508|-2.795|0.530
72432573|NCT02501811|144377766|SUPERIORITY||Mean Difference (Final Values)|1.21|STANDARD_ERROR_OF_MEAN|3.05||0.761|TWO_SIDED|95.0|-4.91|7.33|||ANCOVA|The change in LVESVI was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t test|||7.330|-4.910|0.761
72432574|NCT02501811|144377766|SUPERIORITY||Mean Difference (Final Values)|-2.15|STANDARD_ERROR_OF_MEAN|3.12||0.669|TWO_SIDED|95.0|-8.426|4.132|||ANCOVA|The change in LVESVI was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t test|||4.132|-8.426|0.669
72493652|NCT03048422|144516479|SUPERIORITY||Risk Difference (RD)|-4.3||||0.023|TWO_SIDED|95.0|-8.0|-0.6|||Wald test of two proportions|||Null hypothesis of no difference between groups (DTG+FTC/TDF - EFV/FTC/TDF).||-0.6|-8.0|0.023
72432575|NCT02501811|144377767|SUPERIORITY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.02||0.989|TWO_SIDED|95.0|-0.048|0.04|||ANCOVA|The change in left ventricular sphericity index was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t test|||0.040|-0.048|0.989
72432576|NCT02501811|144377767|SUPERIORITY||Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.02||0.493|TWO_SIDED|95.0|-0.056|0.033|||ANCOVA|The change in left ventricular sphericity index was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t test|||0.033|-0.056|0.493
72432577|NCT02501811|144377767|SUPERIORITY||Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.02||0.926|TWO_SIDED|95.0|-0.053|0.039|||ANCOVA|The change in left ventricular sphericity index was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t test|||0.039|-0.053|0.926
72432578|NCT02501811|144377767|SUPERIORITY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.02||0.904|TWO_SIDED|95.0|-0.041|0.047|||ANCOVA|The change in left ventricular sphericity index was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t test|||0.047|-0.041|0.904
72432579|NCT02501811|144377767|SUPERIORITY||Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.02||0.476|TWO_SIDED|95.0|-0.035|0.049|||ANCOVA|The change in left ventricular sphericity index was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t test|||0.049|-0.035|0.476
72432580|NCT02501811|144377767|SUPERIORITY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.02||0.515|TWO_SIDED|95.0|-0.04|0.048|||ANCOVA|The change in left ventricular sphericity index was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t test|||0.048|-0.040|0.515
72432581|NCT02501811|144377768|SUPERIORITY||Mean Difference (Final Values)|-0.04|STANDARD_ERROR_OF_MEAN|0.85||0.569|TWO_SIDED|95.0|-1.77|1.687|||ANCOVA|The change in scar size percent was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t test|||1.687|-1.770|0.569
72432582|NCT02501811|144377768|SUPERIORITY||Mean Difference (Final Values)|-0.17|STANDARD_ERROR_OF_MEAN|0.8||0.767|TWO_SIDED|95.0|-1.792|1.457|||ANCOVA|The change in scar size percent was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t test|||1.457|-1.792|0.767
72432583|NCT02501811|144377768|SUPERIORITY||Mean Difference (Final Values)|-0.52|STANDARD_ERROR_OF_MEAN|0.71||0.261|TWO_SIDED|95.0|-1.965|0.921|||ANCOVA|The change in scar size percent was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t test|||0.921|-1.965|0.261
72432584|NCT02501811|144377768|SUPERIORITY||Mean Difference (Final Values)|0.48|STANDARD_ERROR_OF_MEAN|0.86||0.587|TWO_SIDED|95.0|-1.261|2.222|||ANCOVA|The change in scar size percent was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t test|||2.222|-1.261|0.587
72432585|NCT02501811|144377768|SUPERIORITY||Mean Difference (Final Values)|0.13|STANDARD_ERROR_OF_MEAN|0.93||0.994|TWO_SIDED|95.0|-1.763|2.014|||ANCOVA|The change in scar size percent was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t test|||2.014|-1.763|0.994
72432586|NCT02501811|144377768|SUPERIORITY||Mean Difference (Final Values)|-0.36|STANDARD_ERROR_OF_MEAN|0.81||0.639|TWO_SIDED|95.0|-1.993|1.283|||ANCOVA|The change in scar size percent was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t test|||1.283|-1.993|0.639
72432587|NCT02501811|144377769|SUPERIORITY||Mean Difference (Final Values)|0.44|STANDARD_ERROR_OF_MEAN|1.42||0.992|TWO_SIDED|95.0|-2.437|3.319|||ANCOVA|The change in scar tissue mass was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t-test|||3.319|-2.437|0.992
72432588|NCT02501811|144377769|SUPERIORITY||Mean Difference (Final Values)|0.18|STANDARD_ERROR_OF_MEAN|1.22||0.862|TWO_SIDED|95.0|-2.278|2.643|||ANCOVA|The change in scar tissue mass was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t-test|||2.643|-2.278|0.862
72432589|NCT02501811|144377769|SUPERIORITY||Mean Difference (Final Values)|-1.2|STANDARD_ERROR_OF_MEAN|1.31||0.217|TWO_SIDED|95.0|-3.846|1.443|||ANCOVA|The change in scar tissue mass was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t-test|||1.443|-3.846|0.217
72432590|NCT02501811|144377769|SUPERIORITY||Mean Difference (Final Values)|1.64|STANDARD_ERROR_OF_MEAN|1.47||0.327|TWO_SIDED|95.0|-1.325|4.611|||ANCOVA|The change in scar tissue mass was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t-test|||4.611|-1.325|0.327
72432591|NCT02501811|144377769|SUPERIORITY||Mean Difference (Final Values)|0.26|STANDARD_ERROR_OF_MEAN|1.39||0.859|TWO_SIDED|95.0|-2.551|3.068|||ANCOVA|The change in scar tissue mass was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t-test|||3.068|-2.551|0.859
72432592|NCT02501811|144377769|SUPERIORITY||Mean Difference (Final Values)|-1.38|STANDARD_ERROR_OF_MEAN|1.27||0.338|TWO_SIDED|95.0|-3.952|1.184|||ANCOVA|The change in scar tissue mass was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t-test|||1.184|-3.952|0.338
72432593|NCT02501811|144377770|SUPERIORITY||Mean Difference (Final Values)|-1.02|STANDARD_ERROR_OF_MEAN|0.71||0.157|TWO_SIDED|95.0|-2.456|0.411|||ANCOVA|The change in peak VO2 was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t test|||0.411|-2.456|0.157
72432594|NCT02501811|144377770|SUPERIORITY||Mean Difference (Final Values)|-0.97|STANDARD_ERROR_OF_MEAN|0.9||0.428|TWO_SIDED|95.0|-2.798|0.859|||ANCOVA|The change in peak VO2 was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t test|||0.859|-2.798|0.428
72432595|NCT02501811|144377770|SUPERIORITY||Mean Difference (Final Values)|0.63|STANDARD_ERROR_OF_MEAN|0.73||0.382|TWO_SIDED|95.0|-0.83|2.093|||ANCOVA|The change in peak VO2 was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t test|||2.093|-0.83|0.382
72432596|NCT02501811|144377770|SUPERIORITY||Mean Difference (Final Values)|-1.65|STANDARD_ERROR_OF_MEAN|0.8||0.056|TWO_SIDED|95.0|-3.255|-0.052|||ANCOVA|The change in peak VO2 was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t test|||-0.052|-3.255|0.056
72432597|NCT02501811|144377770|SUPERIORITY||Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.96||0.61|TWO_SIDED|95.0|-1.991|1.885|||ANCOVA|The change in peak VO2 was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t test|||1.885|-1.991|0.610
72493653|NCT03048422|144516479|SUPERIORITY||Risk Difference (RD)|-5.2||||0.003|TWO_SIDED|95.0|-8.7|-1.8|||Wald test of two proportions|||Null hypothesis of no difference between groups (DTG+FTC/TAF - EFV/FTC/TDF).||-1.8|-8.7|0.003
72432598|NCT02501811|144377770|SUPERIORITY||Mean Difference (Final Values)|1.6|STANDARD_ERROR_OF_MEAN|0.97||0.195|TWO_SIDED|95.0|-0.356|3.557|||ANCOVA|The change in peak VO2 was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t test|||3.557|-0.356|0.195
72432599|NCT02501811|144377771|SUPERIORITY||Mean Difference (Final Values)|18.57|STANDARD_ERROR_OF_MEAN|19.01||0.348|TWO_SIDED|95.0|-19.537|56.687|||ANCOVA|The change in exercise tolerance was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t test|||56.687|-19.537|0.348
72432600|NCT02501811|144377771|SUPERIORITY||Mean Difference (Final Values)|23.19|STANDARD_ERROR_OF_MEAN|17.88||0.23|TWO_SIDED|95.0|-12.759|59.134|||ANCOVA|The change in exercise tolerance was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t test|||59.134|-12.759|0.230
72432601|NCT02501811|144377771|SUPERIORITY||Mean Difference (Final Values)|1.69|STANDARD_ERROR_OF_MEAN|16.21||0.905|TWO_SIDED|95.0|-30.974|34.361|||ANCOVA|The change in exercise tolerance was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t test|||34.361|-30.974|0.905
72432602|NCT02501811|144377771|SUPERIORITY||Mean Difference (Final Values)|16.88|STANDARD_ERROR_OF_MEAN|15.98||0.335|TWO_SIDED|95.0|-15.267|49.03|||ANCOVA|The change in exercise tolerance was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t test|||49.030|-15.267|0.335
72432603|NCT02501811|144377771|SUPERIORITY||Mean Difference (Final Values)|-4.61|STANDARD_ERROR_OF_MEAN|17.68||0.827|TWO_SIDED|95.0|-40.106|30.88|||ANCOVA|The change in exercise tolerance was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t test|||30.880|-40.106|0.827
72432604|NCT02501811|144377771|SUPERIORITY||Mean Difference (Final Values)|-21.49|STANDARD_ERROR_OF_MEAN|14.63||0.163|TWO_SIDED|95.0|-50.989|8.001|||ANCOVA|The change in exercise tolerance was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t test|||8.001|-50.989|0.163
72432605|NCT02501811|144377772|SUPERIORITY||Mean Difference (Final Values)|-9.64|STANDARD_ERROR_OF_MEAN|4.63||0.023|TWO_SIDED|95.0|-18.915|-0.357|||ANCOVA|The change in MLHFQ summary score was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t test|||-0.357|-18.915|0.023
72432606|NCT02501811|144377772|SUPERIORITY||Mean Difference (Final Values)|-15.09|STANDARD_ERROR_OF_MEAN|5.84||0.05|TWO_SIDED|95.0|-26.871|-3.319|||ANCOVA|The change in MLHFQ summary score was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t test|||-3.319|-26.871|0.050
72432607|NCT02501811|144377772|SUPERIORITY||Mean Difference (Final Values)|-2.97|STANDARD_ERROR_OF_MEAN|5.86||0.119|TWO_SIDED|95.0|-14.784|8.836|||ANCOVA|The change in MLHFQ summary score was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t test|||8.836|-14.784|0.119
72432608|NCT02501811|144377772|SUPERIORITY||Mean Difference (Final Values)|-6.66|STANDARD_ERROR_OF_MEAN|5.66||0.845|TWO_SIDED|95.0|-18.087|4.762|||ANCOVA|The change in MLHFQ summary score was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t test|||4.762|-18.087|0.845
72432609|NCT02501811|144377772|SUPERIORITY||Mean Difference (Final Values)|5.46|STANDARD_ERROR_OF_MEAN|5.64||0.976|TWO_SIDED|95.0|-5.931|16.848|||ANCOVA|The change in MLHFQ summary score was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t test|||16.848|-5.931|0.976
72432610|NCT02501811|144377772|SUPERIORITY||Mean Difference (Final Values)|12.12|STANDARD_ERROR_OF_MEAN|6.69||0.717|TWO_SIDED|95.0|-1.337|25.578|||ANCOVA|The change in MLHFQ summary score was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t test|||25.578|-1.337|0.717
72432611|NCT02501811|144377773|SUPERIORITY||Mean Difference (Final Values)|-1411.7|STANDARD_ERROR_OF_MEAN|840.6||0.11|TWO_SIDED|95.0|-3108.3|284.9|||ANCOVA|Change in NT-proBNP value compared using ANCOVA analyses adjusting for baseline values. Data log transformed, p-values obtained from transformed data|Confidence intervals based on t test|||284.9|-3108.3|0.110
72432612|NCT02501811|144377773|SUPERIORITY||Mean Difference (Final Values)|-634.6|STANDARD_ERROR_OF_MEAN|405.1||0.112|TWO_SIDED|95.0|-1460.7|191.4|||ANCOVA|Change in NT-proBNP value compared using ANCOVA analyses adjusting for baseline values. Data log transformed, p-values obtained from transformed data|Confidence intervals based on t test|||191.4|-1460.7|0.112
72432613|NCT02501811|144377773|SUPERIORITY||Mean Difference (Final Values)|-483.2|STANDARD_ERROR_OF_MEAN|400.7||0.891|TWO_SIDED|95.0|-1301.5|335.2|||ANCOVA|Change in NT-proBNP value compared using ANCOVA analyses adjusting for baseline values. Data log transformed, p-values obtained from transformed data|Confidence intervals based on t test|||335.2|-1301.5|0.891
72432614|NCT02501811|144377773|SUPERIORITY||Mean Difference (Final Values)|-928.6|STANDARD_ERROR_OF_MEAN|754.2||0.009|TWO_SIDED|95.0|-2470.7|613.6|||ANCOVA|Change in NT-proBNP value compared using ANCOVA analyses adjusting for baseline values. Data log transformed, p-values obtained from transformed data|Confidence intervals based on t test|||613.6|-2470.7|0.009
72432615|NCT02501811|144377773|SUPERIORITY||Mean Difference (Final Values)|-777.1|STANDARD_ERROR_OF_MEAN|756.5||0.661|TWO_SIDED|95.0|-2323.2|769.1|||ANCOVA|Change in NT-proBNP value compared using ANCOVA analyses adjusting for baseline values. Data log transformed, p-values obtained from transformed data|Confidence intervals based on t test|||769.1|-2323.2|0.661
72432616|NCT02501811|144377773|SUPERIORITY||Mean Difference (Final Values)|151.5|STANDARD_ERROR_OF_MEAN|162.2||0.015|TWO_SIDED|95.0|-175.4|478.4|||ANCOVA|Change in NT-proBNP value compared using ANCOVA analyses adjusting for baseline values. Data log transformed, p-values obtained from transformed data|Confidence intervals based on t test|||478.4|-175.4|0.015
72432617|NCT02501811|144377774|OTHER||slope of time|0.267|STANDARD_ERROR_OF_MEAN|0.241||0.269|TWO_SIDED|||||No adjustments for multiplicity were made in this Phase II trial|Repeated Measures Linear Regression||"Standard error of the mean is the standard error of the estimate of the slope of time."|Repeated-measures linear regression models were used to address trajectories (upward or downward trends) over time within each of the 4 treatment groups. Results of the overall model are reported||||0.269
72432618|NCT02501811|144377775|OTHER||slope of time|0.141|STANDARD_ERROR_OF_MEAN|0.153||0.361|TWO_SIDED|||||No adjustments for multiplicity were made in this Phase II trial|Repeated Measures Linear Regression||"Standard error of the mean is the standard error of the estimate of the slope of time."|Repeated-measures linear regression models were used to address trajectories (upward or downward trends) over time within each of the 4 treatment groups. Results of the overall model are reported.||||0.361
72432619|NCT02501811|144377776|OTHER||slope of time|-0.267|STANDARD_ERROR_OF_MEAN|0.164||0.107|TWO_SIDED|||||No adjustments for multiplicity were made in this Phase II trial|Repeated Measures Linear Regression||"Standard error of the mean is the standard error of the estimate of the slope of time."|Repeated-measures linear regression models were used to address trajectories (upward or downward trends) over time within each of the 4 treatment groups. Results of the overall model are reported.||||0.107
72432620|NCT02501811|144377777|OTHER||slope of time|1.395|STANDARD_ERROR_OF_MEAN|0.829||0.095|TWO_SIDED|||||No adjustments for multiplicity were made in this Phase II trial|Repeated Measures Linear Regression||"Standard error of the mean is the standard error of the estimate of the slope of time."|Repeated-measures linear regression models were used to address trajectories (upward or downward trends) over time within each of the 4 treatment groups. Results of the overall model are reported.||||0.095
72432621|NCT02501811|144377778|OTHER||slope of time|0.603|STANDARD_ERROR_OF_MEAN|0.683||0.379|TWO_SIDED|||||No adjustments for multiplicity were made in this Phase II trial|Repeated Measures Linear Regression||"Standard error of the mean is the standard error of the estimate of the slope of time."|Repeated-measures linear regression models were used to address trajectories (upward or downward trends) over time within each of the 4 treatment groups. Results of the overall model are reported.||||0.379
72432622|NCT02501811|144377779|OTHER||slope of time|0.003|STANDARD_ERROR_OF_MEAN|0.004||0.401|TWO_SIDED|||||No adjustments for multiplicity were made in this Phase II trial|Repeated Measures Linear Regression||"Standard error of the mean is the standard error of the estimate of the slope of time."|Repeated-measures linear regression models were used to address trajectories (upward or downward trends) over time within each of the 4 treatment groups. Results of the overall model are reported.||||0.401
72432623|NCT02501811|144377780|OTHER||slope of time|-0.244|STANDARD_ERROR_OF_MEAN|0.158||0.126|TWO_SIDED|||||No adjustments for multiplicity were made in this Phase II trial|Repeated Measures Linear Regression||"Standard error of the mean is the standard error of the estimate of the slope of time."|Repeated-measures linear regression models were used to address trajectories (upward or downward trends) over time within each of the 4 treatment groups. Results of the overall model are reported.||||0.126
72432624|NCT02501811|144377781|OTHER||slope of time|-0.42|STANDARD_ERROR_OF_MEAN|0.281||0.139|TWO_SIDED|||||No adjustments for multiplicity were made in this Phase II trial|Repeated Measures Linear Regression||"Standard error of the mean is the standard error of the estimate of the slope of time."|Repeated-measures linear regression models were used to address trajectories (upward or downward trends) over time within each of the 4 treatment groups. Results of the overall model are reported.||||0.139
72432625|NCT02501811|144377782|OTHER||slope of time|-0.133|STANDARD_ERROR_OF_MEAN|0.184||0.472|TWO_SIDED|||||No adjustments for multiplicity were made in this Phase II trial|Repeated Measures Linear Regression||"Standard error of the mean is the standard error of the estimate of the slope of time."|Repeated-measures linear regression models were used to address trajectories (upward or downward trends) over time within each of the 4 treatment groups. Results of the overall model are reported.||||0.472
72432626|NCT02501811|144377783|OTHER||slope of time|6.544|STANDARD_ERROR_OF_MEAN|2.882||0.025|TWO_SIDED|||||No adjustments for multiplicity were made in this Phase II trial|Repeated Measures Linear Regression||"Standard error of the mean is the standard error of the estimate of the slope of time."|Repeated-measures linear regression models were used to address trajectories (upward or downward trends) over time within each of the 4 treatment groups. Results of the overall model are reported.||||0.025
72432627|NCT02501811|144377784|OTHER||slope with interaction|-7.08|STANDARD_ERROR_OF_MEAN|3.3||0.037|TWO_SIDED||||||Regression, Linear|||Repeated-measures linear regression models were used to address trajectories (upward or downward trends) over time within each of the 4 treatment groups. A time by treatment interaction was assessed.||||0.037
72432628|NCT02501811|144377784|OTHER||slope with interaction|-6.78|STANDARD_ERROR_OF_MEAN|3.18||0.035|TWO_SIDED||||||Regression, Linear|||Repeated-measures linear regression models were used to address trajectories (upward or downward trends) over time within each of the 4 treatment groups. A time by treatment interaction was assessed.||||0.035
72432629|NCT02501811|144377785|OTHER||slope of time|84.557|STANDARD_ERROR_OF_MEAN|35.81||0.092|TWO_SIDED|||||No adjustments for multiplicity were made in this Phase II trial|Repeated Measures Linear Regression||"Standard error of the mean is the standard error of the estimate of the slope of time."|Repeated-measures linear regression models were used to address trajectories (upward or downward trends) over time within each of the 4 treatment groups. Results of the overall model are reported.||||0.092
72432630|NCT02857283|144377827|SUPERIORITY|||||||0.46|||||||ANOVA|paired||||||0.46
72432631|NCT02857283|144377828|SUPERIORITY|||||||0.0481|||||||ANOVA|Paired||||||0.0481
72432632|NCT02857283|144377829|SUPERIORITY|||||||0.0179|||||||ANOVA|||||||0.0179
72432633|NCT02857283|144377830|SUPERIORITY|||||||0.1|||||||ANOVA|paired||||||0.10
72432634|NCT02857283|144377831|SUPERIORITY|||||||0.69|||||||ANOVA|paired||||||0.69
72432635|NCT02857283|144377832|SUPERIORITY|||||||0.27|||||||ANOVA|paired||||||0.27
72432636|NCT02857283|144377833|SUPERIORITY|||||||0.5|||||||ANOVA|paired||||||0.50
72432637|NCT02857283|144377834|SUPERIORITY|||||||0.54|||||||Wilcoxon signed rank test|||||||0.54
72432638|NCT02857283|144377835|SUPERIORITY|||||||0.9|||||||ANOVA|paired||||||0.90
72432639|NCT02857283|144377837|SUPERIORITY|||||||0.64|||||||Wilcoxon signed rank test|||||||0.64
72432640|NCT02857283|144377838|SUPERIORITY|||||||0.79|||||||Wilcoxon signed rank test|||||||0.79
72432641|NCT02857283|144377839|SUPERIORITY|||||||0.094|||||||ANOVA|||||||0.094
72432642|NCT01207908|144377840|SUPERIORITY||Mean Difference (Final Values)|-8.5||||0.53|TWO_SIDED|95.0|-37.1|20.1|||t-test, 2 sided|||||20.1|-37.1|0.53
72432643|NCT01207908|144377841|SUPERIORITY||Mean Difference (Final Values)|-2.66|||<|0.0001|TWO_SIDED|95.0|-3.78|-1.55|||t-test, 2 sided|||||-1.55|-3.78|<0.0001
72432644|NCT01207908|144377842|SUPERIORITY||Mean Difference (Final Values)|0.56||||0.53|TWO_SIDED|95.0|-1.26|2.38|||t-test, 2 sided|||||2.38|-1.26|0.53
72432645|NCT05074498|144377883|OTHER||Least square mean difference|-0.35||||0.0838|TWO_SIDED|95.0|-0.741|0.047|||Mixed Models Analysis|||||0.047|-0.741|0.0838
72432646|NCT03613129|144377923|NON_INFERIORITY|Comparing 28-day pre-treatment mean TDSS and 28-day post-treatment mean TDSS||||||0.011|TWO_SIDED|95.0|||||t-test, 2 sided|||||||0.011
72432647|NCT03613129|144377923|NON_INFERIORITY|Comparing 28-day pre-treatment mean TDSS and 28-day post-treatment mean TDSS||||||0.136|TWO_SIDED|95.0|||||t-test, 2 sided|||||||0.136
72432648|NCT03613129|144377923|NON_INFERIORITY|Comparing 28-day pre-treatment mean TDSS and 28-day post-treatment mean TDSS||||||0.009|TWO_SIDED|95.0|||||t-test, 2 sided|||||||0.009
72373058|NCT01578850|144256617|SUPERIORITY_OR_OTHER||Difference in proportions|5.9||||0.196|TWO_SIDED|95.0|-0.6|12.4|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||ACR 90: Week 52||12.40|-0.60|0.196
72373059|NCT01578850|144256619|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9||||0.062|TWO_SIDED|95.0|-1.84|0.05|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||28 Tender Joint Count: Week 28||0.05|-1.84|0.062
72373060|NCT01578850|144256619|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.34||||0.015|TWO_SIDED|95.0|-2.41|-0.27|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||28 Tender Joint Count: Week 36||-0.27|-2.41|0.015
72373061|NCT01578850|144256619|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.65||||0.003|TWO_SIDED|95.0|-2.72|-0.57|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||28 Tender Joint Count: Week 44||-0.57|-2.72|0.003
72373062|NCT01578850|144256619|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.75||||0.002|TWO_SIDED|95.0|-2.85|-0.66|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||28 Tender Joint Count: Week 52||-0.66|-2.85|0.002
72373063|NCT01578850|144256619|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.13||||0.68|TWO_SIDED|95.0|-0.77|0.5|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||28 Swollen Joint Count: Week 28||0.50|-0.77|0.680
72373064|NCT01578850|144256619|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.29||||0.437|TWO_SIDED|95.0|-1.04|0.45|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||28 Swollen Joint Count: Week 36||0.45|-1.04|0.437
72373065|NCT01578850|144256619|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.57||||0.131|TWO_SIDED|95.0|-1.31|0.17|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||28 Swollen Joint Count: Week 44||0.17|-1.31|0.131
72373066|NCT01578850|144256619|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.48||||0.199|TWO_SIDED|95.0|-1.22|0.25|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||28 Swollen Joint Count: Week 52||0.25|-1.22|0.199
72373067|NCT01578850|144256619|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.16||||0.115|TWO_SIDED|95.0|-2.6|0.28|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||68 Tender Joint Count: Week 28||0.28|-2.60|0.115
72373068|NCT01578850|144256619|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.88||||0.017|TWO_SIDED|95.0|-3.42|-0.35|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||68 Tender Joint Count: Week 36||-0.35|-3.42|0.017
72373069|NCT01578850|144256619|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.34||||0.004|TWO_SIDED|95.0|-3.91|-0.76|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||68 Tender Joint Count: Week 44||-0.76|-3.91|0.004
72373070|NCT01578850|144256619|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.58||||0.002|TWO_SIDED|95.0|-4.19|-0.97|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||68 Tender Joint Count: Week 52||-0.97|-4.19|0.002
72373071|NCT01578850|144256619|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.36||||0.368|TWO_SIDED|95.0|-1.13|0.42|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||68 Swollen Joint Count: Week 28||0.42|-1.13|0.368
72373072|NCT01578850|144256619|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.57||||0.208|TWO_SIDED|95.0|-1.46|0.32|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||68 Swollen Joint Count: Week 36||0.32|-1.46|0.208
72373073|NCT01578850|144256619|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.84||||0.064|TWO_SIDED|95.0|-1.73|0.05|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||68 Swollen Joint Count: Week 44||0.05|-1.73|0.064
72373074|NCT01578850|144256619|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.78||||0.081|TWO_SIDED|95.0|-1.66|0.1|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||68 Swollen Joint Count: Week 52||0.10|-1.66|0.081
72373075|NCT01578850|144256621|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.53||||0.005|TWO_SIDED|95.0|-0.9|-0.16|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||Week 28||-0.16|-0.90|0.005
72373076|NCT01578850|144256621|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.78|||<|0.001|TWO_SIDED|95.0|-1.18|-0.38|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||Week 36||-0.38|-1.18|<0.001
72373077|NCT01578850|144256621|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.94|||<|0.001|TWO_SIDED|95.0|-1.35|-0.54|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||Week 44||-0.54|-1.35|<0.001
72373078|NCT01578850|144256621|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.93|||<|0.001|TWO_SIDED|95.0|-1.33|-0.53|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||Week 52||-0.53|-1.33|<0.001
72373079|NCT01578850|144256623|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5||||0.048|TWO_SIDED|95.0|-1.0|-0.01|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||Week 28||-0.01|-1.00|0.048
72432649|NCT03613129|144377923|NON_INFERIORITY|Comparing 28-day pre-treatment mean TDSS and 28-day post-treatment mean TDSS||||||0.451|TWO_SIDED|95.0|||||t-test, 2 sided|||||||0.451
72432650|NCT03613129|144377923|NON_INFERIORITY|Comparing 28-day pre-treatment mean TDSS and 28-day post-treatment mean TDSS||||||0.24|TWO_SIDED|95.0|||||t-test, 2 sided|||||||0.240
72432651|NCT03613129|144377924|NON_INFERIORITY|Comparing pre-treatment PCS (at Visit 3) and post-treatment PCS (at Visit 6)||||||0.039|||||||t-test, 2 sided|||||||0.039
72432652|NCT03613129|144377924|NON_INFERIORITY|Comparing pre-treatment PCS (at Visit 3) and post-treatment PCS (at Visit 6)||||||0.191|||||||t-test, 2 sided|||||||0.191
72432653|NCT03613129|144377924|NON_INFERIORITY|Comparing pre-treatment PCS (at Visit 3) and post-treatment PCS (at Visit 6)||||||0.016|||||||t-test, 2 sided|||||||0.016
72432654|NCT03613129|144377924|NON_INFERIORITY|Comparing pre-treatment PCS (at Visit 3) and post-treatment PCS (at Visit 6)||||||0.053|||||||t-test, 2 sided|||||||0.053
72432655|NCT03613129|144377924|NON_INFERIORITY|Comparing pre-treatment PCS (at Visit 3) and post-treatment PCS (at Visit 6)||||||0.06|||||||t-test, 2 sided|||||||0.060
72432656|NCT03613129|144377925|NON_INFERIORITY|Comparing pre-treatment MCS (at Visit 3) and post-treatment MCS (at Visit 6)||||||0.587|||||||t-test, 2 sided|||||||0.587
72432657|NCT03613129|144377925|NON_INFERIORITY|Comparing pre-treatment MCS (at Visit 3) and post-treatment MCS (at Visit 6)||||||0.618|||||||t-test, 2 sided|||||||0.618
72432658|NCT03613129|144377925|NON_INFERIORITY|Comparing pre-treatment MCS (at Visit 3) and post-treatment MCS (at Visit 6)||||||0.634|||||||t-test, 2 sided|||||||0.634
72432659|NCT03613129|144377925|NON_INFERIORITY|Comparing pre-treatment MCS (at Visit 3) and post-treatment MCS (at Visit 6)||||||0.355|||||||t-test, 2 sided|||||||0.355
72373080|NCT01578850|144256623|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.93|||<|0.001|TWO_SIDED|95.0|-1.44|-0.43|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||Week 36||-0.43|-1.44|<0.001
72373081|NCT01578850|144256623|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.83||||0.001|TWO_SIDED|95.0|-1.33|-0.33|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||Week 44||-0.33|-1.33|0.001
72373082|NCT01578850|144256623|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.82||||0.002|TWO_SIDED|95.0|-1.33|-0.31|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||Week 52||-0.31|-1.33|0.002
72373083|NCT01578850|144256625|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.11||||0.033|TWO_SIDED|95.0|-27.07|-1.16|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||Week 28||-1.16|-27.07|0.033
72373084|NCT01578850|144256625|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.04||||0.013|TWO_SIDED|95.0|-30.39|-3.68|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||Week 36||-3.68|-30.39|0.013
72373085|NCT01578850|144256625|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.54||||0.019|TWO_SIDED|95.0|-30.35|-2.73|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||Week 44||-2.73|-30.35|0.019
72373086|NCT01578850|144256625|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.66||||0.007|TWO_SIDED|95.0|-33.78|-5.54|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||Week 52||-5.54|-33.78|0.007
72373087|NCT01578850|144256627|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.21||||0.078|TWO_SIDED|95.0|-8.91|0.48|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||General Health VAS: Week 28||0.48|-8.91|0.078
72373088|NCT01578850|144256627|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.54||||0.003|TWO_SIDED|95.0|-12.49|-2.59|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||General Health VAS: Week 36||-2.59|-12.49|0.003
72373089|NCT01578850|144256627|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.19||||0.001|TWO_SIDED|95.0|-13.2|-3.18|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||General Health VAS: Week 44||-3.18|-13.20|0.001
72373090|NCT01578850|144256627|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.6|||<|0.001|TWO_SIDED|95.0|-13.64|-3.55|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||General Health VAS: Week 52||-3.55|-13.64|<0.001
72373091|NCT01578850|144256627|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.91||||0.017|TWO_SIDED|95.0|-10.75|-1.06|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||Pain VAS: Week 28||-1.06|-10.75|0.017
72432660|NCT03613129|144377925|NON_INFERIORITY|Comparing pre-treatment MCS (at Visit 3) and post-treatment MCS (at Visit 6)||||||0.417|||||||t-test, 2 sided|||||||0.417
72432661|NCT01770860|144377927|SUPERIORITY_OR_OTHER||||||<|0.0001||||||The p-values presented were for each of the bandage groups compared to no treatment group.|Mixed Models Analysis|P-value is from mixed model with Treatment (trt) as fix effect, and subject as random effect.||||||<0.0001
72432662|NCT01770860|144377928|SUPERIORITY_OR_OTHER||||||<|0.0001||||||The p-values presented were for each of the bandage groups compared to no treatment group.|Mixed Models Analysis|P-value is from mixed model with treatment (trt) as fix effect, and subject as random effect.||||||<0.0001
72432663|NCT01770860|144377929|SUPERIORITY_OR_OTHER||||||<|0.0001||||||The p-values presented were for each of the bandage groups compared to no treatment group.|Mixed Models Analysis|P-value is from mixed model with treatment (trt) as fix effect, and subject as random effect.||||||<0.0001
72432664|NCT01770860|144377930|SUPERIORITY_OR_OTHER||||||<|0.0001||||||The p-values presented were for each of the bandage groups compared to no treatment group.|Mixed Models Analysis|P-value is from mixed model with treatment (trt) as fix effect, and subject as random effect.||||||<0.0001
72432665|NCT01770860|144377931|SUPERIORITY_OR_OTHER|||||||0.0476|||||||Mixed Models Analysis|P-value is from mixed model with treatment (trt) as fix effect, and subject as random effect||||||0.0476
72493654|NCT03048422|144516481|NON_INFERIORITY|Equivalence margin was a 10% difference between groups.|Risk Difference (RD)|-3.6||||0.16|TWO_SIDED|95.0|-8.8|1.5|||Wald test of two proportions|||||1.5|-8.8|0.16
72432666|NCT03432533|144377934|NON_INFERIORITY|Conclusions for the primary efficacy hypothesis of efficacy of self-administration of romosozumab by AI/Pen compared with HCP-administered romosozumab by PFS at lumbar spine BMD at Month 6 was made using a 1-sided test with type 1 error rate of 0.025 and noninferiority margin of -2.0%.|LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.6||0.84|TWO_SIDED|95.0|-1.3|1.0|||ANCOVA|||||1.0|-1.3|0.84
72432667|NCT01112735|144377944|SUPERIORITY|||||||0.5621|||||||Wilcoxon (Mann-Whitney)|||||||0.5621
72432668|NCT01112735|144377945|SUPERIORITY|||||||0.3595|||||||Wilcoxon (Mann-Whitney)|||||||0.3595
72432669|NCT01112735|144377946|SUPERIORITY|||||||0.9417|||||||Wilcoxon (Mann-Whitney)|||Day 3||||0.9417
72432670|NCT01112735|144377946|SUPERIORITY|||||||0.5488|||||||Wilcoxon (Mann-Whitney)|||Day 7||||0.5488
72432671|NCT01112735|144377946|SUPERIORITY|||||||0.7107|||||||Wilcoxon (Mann-Whitney)|||Day 14||||0.7107
72432672|NCT01112735|144377946|SUPERIORITY|||||||0.8809|||||||Wilcoxon (Mann-Whitney)|||Day 28||||0.8809
72432673|NCT01112735|144377946|SUPERIORITY|||||||0.4598|||||||Wilcoxon (Mann-Whitney)|||Day 60||||0.4598
72432674|NCT01112735|144377946|SUPERIORITY|||||||0.3837|||||||Wilcoxon (Mann-Whitney)|||Day 90||||0.3837
72432675|NCT01112735|144377947|SUPERIORITY|||||||0.9699|||||||Wilcoxon (Mann-Whitney)|||Day 3||||0.9699
72432676|NCT01112735|144377947|SUPERIORITY|||||||0.4709|||||||Wilcoxon (Mann-Whitney)|||Day 7||||0.4709
72555351|NCT01929863|144642237|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-45.41|||||TWO_SIDED|95.0|-72.8|-18.03|||||The point estimate was calculated as least square mean difference (net values) of Treatment A-GSK2330672 + Metformin and Treatment B-Placebo + Metformin for Maximum (10-14 h) Value.|Treatment A-GSK2330672 + Metformin versus Treatment B-Placebo + Metformin for Maximum (10-14 h) Value.||-18.03|-72.80|
72432677|NCT01112735|144377947|SUPERIORITY|||||||0.1406|||||||Wilcoxon (Mann-Whitney)|||Day 14||||0.1406
72432678|NCT01112735|144377947|SUPERIORITY|||||||0.4291|||||||Wilcoxon (Mann-Whitney)|||Day 28||||0.4291
72432679|NCT01112735|144377947|SUPERIORITY|||||||0.2704|||||||Wilcoxon (Mann-Whitney)|||Day 60||||0.2704
72432680|NCT01112735|144377947|SUPERIORITY|||||||0.7564|||||||Wilcoxon (Mann-Whitney)|||Day 90||||0.7564
72432681|NCT03419780|144377950|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
72432682|NCT03419780|144377951|SUPERIORITY|||||||0.79|||||||Wilcoxon (Mann-Whitney)|||||||0.79
72432683|NCT03419780|144377952|SUPERIORITY|||||||0.89|||||||Chi-squared|||||||0.89
72432684|NCT03419780|144377953|SUPERIORITY|||||||0.34|||||||Wilcoxon (Mann-Whitney)|||||||0.34
72432685|NCT03419780|144377954|SUPERIORITY|||||||0.13|||||||Wilcoxon (Mann-Whitney)|||||||0.13
72432686|NCT03419780|144377955|SUPERIORITY|||||||0.55|||||||Wilcoxon (Mann-Whitney)|||||||0.55
72432687|NCT03419780|144377956|SUPERIORITY|||||||1|||||||Chi-squared|||||||1.00
72432688|NCT02775435|144377968|SUPERIORITY||Hazard Ratio (HR)|0.56|||<|0.0001|TWO_SIDED|95.0|0.45|0.7||Treatment comparison stratified by programmed cell death-ligand 1 (PD-L1) status (Tumor Proportion Score \[TPS\] ≥1% vs. \<1%), taxane chemotherapy (paclitaxel vs. nab-paclitaxel) \& geographic region (East Asia vs. non-East Asia)|Regression, Cox|||||0.70|0.45|<0.0001
72432689|NCT02775435|144377969|SUPERIORITY||Hazard Ratio (HR)|0.64||||0.0008|TWO_SIDED|95.0|0.49|0.85||Treatment comparison stratified by programmed cell death-ligand 1 (PD-L1) status (Tumor Proportion Score \[TPS\] ≥1% vs. \<1%), taxane chemotherapy (paclitaxel vs. nab-paclitaxel) \& geographic region (East Asia vs. non-East Asia)|Regression, Cox|||||0.85|0.49|0.0008
72432690|NCT00097253|144377974|SUPERIORITY_OR_OTHER|||||||0.83||95.0|||||Regression, Linear|||Cortisol. Analyses consisted of repeated-measures linear models fit to each dependent variable.IVs assessed in each model were odor, time, gender, expectancy group (primed vs. blind), their interactions;baseline level of the DV was included as a covariate. Post hoc tests were used as appropriate. A two-sided significance level of alpha = 0.05 was used. Model controlled for Time 1 baseline.||||0.83
72432691|NCT00097253|144377974|SUPERIORITY_OR_OTHER|||||||0.16||95.0|||||Mixed Models Analysis|||Epinephrine. Analyses consisted of repeated-measures linear models fit to each dependent variable.IVs assessed in each model were odor, time, gender, expectancy group (primed vs. blind), their interactions;baseline level of the DV was included as a covariate. Post hoc tests were used as appropriate. A two-sided significance level of alpha = 0.05 was used. Model controlled for Time 1 baseline.||||0.16
72432692|NCT00097253|144377974|SUPERIORITY_OR_OTHER|||||||0.017||95.0|||||Mixed Models Analysis|||Norepinephrine. Model controlled for Time 1 baseline. Comparing timepoints 4 and 5 for pre versus post stressor, e.g. lemon versus water control; Citrus(5-4)-Water(5-4).||||0.017
72432693|NCT00097253|144377975|SUPERIORITY_OR_OTHER|||||||0.1||95.0|||||Mixed Models Analysis|||IL-6. Mixed effect linear models were used to test the hypothesis. These models included the post-odor and post-stress dependent variable measurements with a covariate for the baseline pre-odor measurement. Base 10 logarithms were used for each dependent variable and baseline covariate.||||0.10
72432694|NCT00097253|144377975|SUPERIORITY_OR_OTHER|||||||0.5||95.0|||||Mixed Models Analysis|||IL-10. Mixed effect linear models were used to test the hypothesis. These models included the post-odor and post-stress dependent variable measurements with a covariate for the baseline pre-odor measurement. Base 10 logarithms were used for each dependent variable and baseline covariate.||||0.50
72432695|NCT00097253|144377976|SUPERIORITY_OR_OTHER|||||||0.6||95.0|||||Mixed Models Analysis|||Repeated-measures mixed effects models were used. Model was fit to the log-transformed data. Analysis applied to odor category, e.g. lavender / lemon / water.||||0.60
72432696|NCT00097253|144377977|SUPERIORITY_OR_OTHER|||||||0.014||95.0|||||Regression, Linear|||The maximum DTH wheal of days 1-3 (24, 48, or 72 h) was used as the dependent variable for each subject at each visit. Visits for subjects with a maximum DTH wheal of 5mm or less were excluded. A repeated measures linear model was used to evaluate odor and placebo effects.||||0.014
72432697|NCT01219855|144377978|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Z-test cmpared 2 independ. proportions|||||||<0.0001
72432698|NCT01219855|144377979|SUPERIORITY_OR_OTHER||||||<|0.01|||||||Mixed effect model|||||||<0.01
72432699|NCT01219855|144377980|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed effect model|||||||<0.0001
72432700|NCT01219855|144377980|SUPERIORITY_OR_OTHER||||||<|0.01|||||||Mixed effect model|||||||<0.01
72432701|NCT01219855|144377981|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed effect model|||||||<0.0001
72432702|NCT01219855|144377982|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Z-test compared 2 independ. proportions|||||||<0.05
72432703|NCT01219855|144377983|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Z-test compared 2 independ. proportions|||The proportion of subjects achieving a ≥20% decrease in plasma iPTH at EOT was greater in the CTAP101 Capsules 60 and 90 μg groups compared to the corresponding placebo group.||||<0.001
72432704|NCT03852433|144378013|OTHER||Difference in percentages|34.0||||0.0003|TWO_SIDED|95.0|14.6|50.4|||Fisher Exact|||||50.4|14.6|0.0003
72432705|NCT03852433|144378013|OTHER||Difference in percentages|15.3||||0.2631|TWO_SIDED|95.0|-8.2|34.2|||Fisher Exact|||||34.2|-8.2|0.2631
72432706|NCT03852433|144378013|OTHER||Difference in percentages|29.3||||0.0197|TWO_SIDED|95.0|1.8|48.2|||Fisher Exact|||||48.2|1.8|0.0197
72432707|NCT03852433|144378013|OTHER||Difference in percentages|-4.7||||0.7186|TWO_SIDED|95.0|-26.3|11.8|||Fisher Exact|||||11.8|-26.3|0.7186
72432708|NCT03852433|144378013|OTHER||Difference in percentages|14.0||||0.2184|TWO_SIDED|95.0|-5.5|32.7|||Fisher Exact|||||32.7|-5.5|0.2184
72432709|NCT03852433|144378013|OTHER||Difference in percentages|-20.0||||0.0283|TWO_SIDED|95.0|-36.1|-3.5|||Fisher Exact|||||-3.5|-36.1|0.0283
72432710|NCT03852433|144378016|OTHER||Difference in percentages|26.0||||0.0134|TWO_SIDED|95.0|6.0|44.0|||Fisher Exact|||||44.0|6.0|0.0134
72432711|NCT03852433|144378017|OTHER||Difference in percentages|28.0||||0.0049|TWO_SIDED|95.0|8.2|45.1|||Fisher Exact|||||45.1|8.2|0.0049
72432712|NCT03852433|144378018|OTHER||Difference in percentages|34.0||||0.0003|TWO_SIDED|95.0|14.6|50.4|||Fisher Exact|||||50.4|14.6|0.0003
72432713|NCT03852433|144378018|OTHER||Difference in percentages|1.0||||1|TWO_SIDED|95.0|-22.8|21.4|||Fisher Exact|||||21.4|-22.8|1.0000
72432714|NCT03852433|144378018|OTHER||Difference in percentages|21.0||||0.1265|TWO_SIDED|95.0|-5.3|42.2|||Fisher Exact|||||42.2|-5.3|0.1265
72432715|NCT03852433|144378018|OTHER||Difference in percentages|-13.0||||0.1863|TWO_SIDED|95.0|-35.3|5.4|||Fisher Exact|||||5.4|-35.3|0.1863
72432716|NCT03852433|144378018|OTHER||Difference in percentages|20.0||||0.0601|TWO_SIDED|95.0|1.0|38.2|||Fisher Exact|||||38.2|1.0|0.0601
72432717|NCT03852433|144378018|OTHER||Difference in percentages|-14.0||||0.1247|TWO_SIDED|95.0|-29.9|1.7|||Fisher Exact|||||1.7|-29.9|0.1247
72432718|NCT03852433|144378019|OTHER||Difference in LS Mean|1.56||||0.0717|TWO_SIDED|95.0|-0.14|3.26|||MMRM|||||3.26|-0.14|0.0717
72432719|NCT03852433|144378019|OTHER||Difference in LS Mean|-1.84||||0.1563|TWO_SIDED|95.0|-4.39|0.71|||MMRM|||||0.71|-4.39|0.1563
72432720|NCT03852433|144378019|OTHER||Difference in LS Mean|-1.8||||0.1626|TWO_SIDED|95.0|-4.33|0.73|||MMRM|||||0.73|-4.33|0.1626
72432721|NCT03852433|144378019|OTHER||Difference in LS Mean|-3.34||||0.0099|TWO_SIDED|95.0|-5.87|-0.82|||MMRM|||||-0.82|-5.87|0.0099
72432722|NCT03852433|144378019|OTHER||Difference in LS Mean|0.07||||0.9384|TWO_SIDED|95.0|-1.67|1.81|||MMRM|||||1.81|-1.67|0.9384
72432723|NCT03852433|144378019|OTHER||Difference in LS Mean|-1.49||||0.0875|TWO_SIDED|95.0|-3.2|0.22|||MMRM|||||0.22|-3.20|0.0875
72432724|NCT03852433|144378020|OTHER||Difference in LS Mean|0.15||||0.8645|TWO_SIDED|95.0|-1.54|1.83|||MMRM|||||1.83|-1.54|0.8645
72432725|NCT03852433|144378020|OTHER||Difference in LS Mean|-0.33||||0.7033|TWO_SIDED|95.0|-2.06|1.39|||MMRM|||||1.39|-2.06|0.7033
72432726|NCT03852433|144378020|OTHER||Difference in LS Mean|-0.48||||0.5806|TWO_SIDED|95.0|-2.18|1.23|||MMRM|||||1.23|-2.18|0.5806
72432727|NCT03852433|144378021|OTHER||Difference in LS Mean|-1.68||||0.1103|TWO_SIDED|95.0|-3.75|0.39|||MMRM|||||0.39|-3.75|0.1103
72432728|NCT03852433|144378021|OTHER||Difference in LS Mean|-2.05||||0.1533|TWO_SIDED|95.0|-4.88|0.77|||MMRM|||||0.77|-4.88|0.1533
72432729|NCT03852433|144378021|OTHER||Difference in LS Mean|-2.22||||0.1129|TWO_SIDED|95.0|-4.98|0.53|||MMRM|||||0.53|-4.98|0.1129
72432730|NCT03852433|144378021|OTHER||Difference in LS Mean|-0.58||||0.6753|TWO_SIDED|95.0|-3.34|2.17|||MMRM|||||2.17|-3.34|0.6753
72432731|NCT03852433|144378021|OTHER||Difference in LS Mean|-0.12||||0.9124|TWO_SIDED|95.0|-2.28|2.04|||MMRM|||||2.04|-2.28|0.9124
72432732|NCT03852433|144378021|OTHER||Difference in LS Mean|1.56||||0.1526|TWO_SIDED|95.0|-0.59|3.7|||MMRM|||||3.70|-0.59|0.1526
72432733|NCT00601965|144378062|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Log Rank|Log rank test = 32.67, df = 3||||||<.001
72432734|NCT00601965|144378063|SUPERIORITY_OR_OTHER|||||||0.01|||||||Mixed Models Analysis|Beta = -0.48, 95% CI = -0.84 to -0.11||||||0.01
72432735|NCT02138916|144378064|SUPERIORITY||Rate ratio|0.96||||0.649|TWO_SIDED|95.0|0.8|1.15|||Negative binomial|Model includes treatment group, EOS cohort, region, background therapy, number of exacerbations in the previous year.||||1.15|0.8|0.6490
72432736|NCT02138916|144378064|SUPERIORITY||Risk Ratio (RR)|0.83||||0.0525|TWO_SIDED|95.0|0.69|1.0|||Negative binomial|Model includes treatment group, EOS cohort, region, background therapy, number of exacerbations in the previous year.||||1.00|0.69|0.0525
72432737|NCT02138916|144378065|SUPERIORITY||Risk Ratio (RR)|1.07||||0.5236|TWO_SIDED|95.0|0.86|1.34|||Negative binomial|Model includes treatment group, region, number of exacerbations in the previous year.||||1.34|0.86|0.5236
72432738|NCT02138916|144378065|SUPERIORITY||Risk Ratio (RR)|1.02||||0.8812|TWO_SIDED|95.0|0.82|1.27|||Negative binomial|Model includes treatment group, EOS cohort, region, number of exacerbations in the previous year.||||1.27|0.82|0.8812
72432739|NCT02138916|144378066|SUPERIORITY||Mean Difference (Final Values)|0.007||||0.755|TWO_SIDED|95.0|-0.035|0.048|||Mixed Models Analysis|Model includes treatment group, baseline FEV1 value, EOS cohort, region, background therapy, visit, and treatment by visit interaction.||||0.048|-0.035|0.7550
72432740|NCT02138916|144378066|SUPERIORITY||Mean Difference (Final Values)|0.021||||0.3285|TWO_SIDED|95.0|-0.021|0.062|||Mixed Models Analysis|Model includes treatment group, baseline FEV1 value, EOS cohort, region, background therapy, visit, and treatment by visit interaction.||||0.062|-0.021|0.3285
72432741|NCT02138916|144378067|SUPERIORITY||Mean Difference (Final Values)|-1.011||||0.2906|TWO_SIDED|95.0|-2.887|0.865|||Mixed Models Analysis|Model includes treatment group, baseline SGRQ score, EOS cohort, region, background therapy, visit, and treatment by visit interaction.||||0.865|-2.887|0.2906
72432742|NCT02138916|144378067|SUPERIORITY||Mean Difference (Final Values)|-2.136||||0.0264|TWO_SIDED|95.0|-4.02|-0.251|||Mixed Models Analysis|Model includes treatment group, baseline SGRQ score, EOS cohort, region, background therapy, visit, and treatment by visit interaction.||||-0.251|-4.020|0.0264
72432743|NCT02138916|144378068|SUPERIORITY||Mean Difference (Final Values)|-0.19||||0.6782|TWO_SIDED|95.0|-1.08|0.7|||Mixed Models Analysis|Model includes treatment group, baseline CAT total score, EOS cohort, region, background therapy, visit, and treatment by visit interaction.||||0.70|-1.08|0.6782
72432744|NCT02138916|144378068|SUPERIORITY||Mean Difference (Final Values)|-0.81||||0.0753|TWO_SIDED|95.0|-1.7|0.08|||Mixed Models Analysis|Model includes treatment group, baseline CAT total score, EOS cohort, region, background therapy, visit, and treatment by visit interaction.||||0.08|-1.70|0.0753
72432745|NCT02138916|144378069|SUPERIORITY||Mean Difference (Final Values)|-0.585||||0.0889|TWO_SIDED|95.0|-1.26|0.089|||Mixed Models Analysis|Model includes treatment group, baseline total score, EOS cohort, region, background therapy, visit, and treatment by visit interaction.||||0.089|-1.260|0.0889
72432746|NCT02138916|144378069|SUPERIORITY||Mean Difference (Final Values)|-0.703||||0.0413|TWO_SIDED|95.0|-1.378|-0.028|||Mixed Models Analysis|Model includes treatment group, baseline total score, EOS cohort, region, background therapy, visit, and treatment by visit interaction.||||-0.028|-1.378|0.0413
72432747|NCT02138916|144378070|SUPERIORITY||Mean Difference (Final Values)|-0.348||||0.0728|TWO_SIDED|95.0|-0.728|0.032|||Mixed Models Analysis|Model includes treatment group, baseline rescue med. use, EOS cohort, region, background therapy, visit, and treatment by visit interaction.||||0.032|-0.728|0.0728
72432748|NCT02138916|144378070|SUPERIORITY||Mean Difference (Final Values)|-0.487||||0.0121|TWO_SIDED|95.0|-0.868|-0.107|||Mixed Models Analysis|Model includes treatment group, baseline rescue med. use, EOS cohort, region, background therapy, visit, and treatment by visit interaction.||||-0.107|-0.868|0.0121
72432749|NCT02138916|144378071|SUPERIORITY||Mean Difference (Final Values)|-0.041||||0.0235|TWO_SIDED|95.0|-0.077|-0.006|||Mixed Models Analysis|Model includes treatment group, baseline prop. of nights awakens., EOS cohort, region, background therapy, visit, and treatment by visit interaction.||||-0.006|-0.077|0.0235
72432750|NCT02138916|144378071|SUPERIORITY||Mean Difference (Final Values)|-0.044||||0.0158|TWO_SIDED|95.0|-0.08|-0.008|||Mixed Models Analysis|Model includes treatment group, baseline prop. of nights awakens., EOS cohort, region, background therapy, visit, and treatment by visit interaction.||||-0.008|-0.080|0.0158
72432751|NCT02138916|144378075|SUPERIORITY||Rate ratio|1.09||||0.408|TWO_SIDED|95.0|0.89|1.34|||Negative binomial|Model includes treatment group, EOS cohort, region, background therapy, number of exacerbations in the previous year.||||1.34|0.89|0.4080
72432752|NCT02138916|144378075|SUPERIORITY||Rate ratio|0.98||||0.8688|TWO_SIDED|95.0|0.8|1.21|||Negative binomial|Model includes treatment group, EOS cohort, region, background therapy, number of exacerbations in the previous year.||||1.21|0.80|0.8688
72432753|NCT02138916|144378076|SUPERIORITY||Odds Ratio (OR)|0.9||||0.485|TWO_SIDED|95.0|0.66|1.22|||Cochran-Mantel-Haenszel|CMH test controlling for EOS cohort, region, and background therapy.||Proportion of participants with \>=1 COPD exacerbation.||1.22|0.66|0.4850
72432754|NCT02138916|144378076|SUPERIORITY||Odds Ratio (OR)|0.89||||0.4489|TWO_SIDED|95.0|0.65|1.21|||Cochran-Mantel-Haenszel|CMH test controlling for EOS cohort, region, and background therapy.||Proportion of participants with \>=1 COPD exacerbation.||1.21|0.65|0.4489
72432755|NCT02138916|144378078|SUPERIORITY||Rate ratio|1.06||||0.7733|TWO_SIDED|95.0|0.73|1.53|||Negative binomial|Model includes treatment group, EOS cohort, region, background therapy, previous year exacerbations associated with hospitalization (Y/N).||||1.53|0.73|0.7733
72432756|NCT02138916|144378078|SUPERIORITY||Rate ratio|0.58||||0.0114|TWO_SIDED|95.0|0.39|0.89|||Nagative binomial|Model includes treatment group, EOS cohort, region, background therapy, previous year exacerbations associated with hospitalization (Y/N).||||0.89|0.39|0.0114
72432757|NCT03499600|144378177|SUPERIORITY|Due to condition differences all analyses controlled for length of intake assessment (in minutes), site, caregiver race/ethnicity, daily stress, and language of assessment delivery.||||||0.03|||||||Regression, Linear|||A power analysis assuming an alpha level = 0.05, beta = 0.2, and power = 0.8, identified a sample ≥82 participants was needed to identify small-to-medium effects (i.e., OR\~2.5).Intent-to-treat analyses were employed. This linear regressions tested condition effects on caregiver perceptions of the extent to which the provider understood the caregivers' values or what is important to them.||||.03
72432758|NCT03499600|144378177|SUPERIORITY|Due to condition differences all analyses controlled for length of intake assessment (in minutes), site, caregiver race/ethnicity, daily stress, and language of assessment delivery.||||||0.68|||||||Regression, Linear|||A power analysis assuming an alpha level = 0.05, beta = 0.2, and power = 0.8, identified a sample ≥82 participants was needed to identify small-to-medium effects (i.e., OR\~2.5).Intent-to-treat analyses were employed.This linear regressions tested condition effects on caregiver satisfaction with the intake.||||.68
72432759|NCT03499600|144378177|SUPERIORITY|Due to condition differences all analyses controlled for length of intake assessment (in minutes), site, caregiver race/ethnicity, daily stress, and language of assessment delivery.||||||0.03|||||||Regression, Linear|||A power analysis assuming an alpha level = 0.05, beta = 0.2, and power = 0.8, identified a sample ≥82 participants was needed to identify small-to-medium effects (i.e., OR\~2.5).Intent-to-treat analyses were employed.This linear regressions tested condition effects on provider perceptions of the extent to which the provider understood the caregivers' values or what is important to them.||||.03
72432760|NCT03499600|144378177|SUPERIORITY|Due to condition differences all analyses controlled for length of intake assessment (in minutes), site, caregiver race/ethnicity, daily stress, and language of assessment delivery.|||||<|0.05|||||||Regression, Linear|||A power analysis assuming an alpha level = 0.05, beta = 0.2, and power = 0.8, identified a sample ≥82 participants was needed to identify small-to-medium effects (i.e., OR\~2.5).Intent-to-treat analyses were employed. This linear regressions tested condition effects on provider satisfaction with the intake.||||<.05
72432761|NCT03499600|144378179|SUPERIORITY|Due to condition differences all analyses controlled for length of intake assessment (in minutes), site, caregiver race/ethnicity, daily stress, and language of assessment delivery.||||||0.93|||||||Regression, Linear|||Power analysis assuming an alpha level = 0.05, beta = 0.2, and power = 0.8, identified a sample ≥82 participants was needed to identify small-to-medium effects (i.e., OR\~2.5).Intent-to-treat analyses were employed. Linear regressions tested condition effects on therapeutic alliance.||||.93
72432762|NCT03499600|144378179|SUPERIORITY|||||||0.9|||||||Regression, Linear|||Tested the moderation effects of language of service reception and condition on therapeutic alliance.||||.90
72493655|NCT03048422|144516481|NON_INFERIORITY|Equivalence margin was a 10% difference between groups.|Risk Difference (RD)|-2.7||||0.38|TWO_SIDED|95.0|-8.7|3.3|||Wald test of two proportions|||||3.3|-8.7|0.38
72493656|NCT03048422|144516481|NON_INFERIORITY|Equivalence margin was a 10% difference between groups.|Risk Difference (RD)|-6.3||||0.023|TWO_SIDED|95.0|-11.8|-0.9|||Wald test of two proportions|||||-0.9|-11.8|0.023
72432763|NCT03499600|144378180|SUPERIORITY|Due to condition differences all analyses controlled for length of intake assessment (in minutes), site, caregiver race/ethnicity, daily stress, and language of assessment delivery. Baseline ECBI score was included as a covariate for the treatment response analyses.||||||0.171|||||||Regression, Logistic|||A power analysis assuming an alpha level = 0.05, beta = 0.2, and power = 0.8, identified a sample ≥82 participants was needed to identify small-to-medium effects (i.e., OR\~2.5).Intent-to-treat analyses were employed. A logistic regression tested condition effects on treatment response.||||.171
72432764|NCT03499600|144378180|SUPERIORITY||||||<|0.05|||||||Regression, Logistic|||Testes the effects of the moderation of language of service delivery and condition on treatment response.||||<.05
72432765|NCT03499600|144378181|SUPERIORITY|Due to condition differences all analyses controlled for length of intake assessment (in minutes), site, caregiver race/ethnicity, daily stress, and language of assessment delivery.||||||0.38|||||||Regression, Linear|||A power analysis assuming an alpha level = 0.05, beta = 0.2, and power = 0.8, identified a sample ≥82 participants was needed to identify small-to-medium effects (i.e., OR\~2.5).Intent-to-treat analyses were employed. Linear regressions tested condition effects on session attendance.||||.38
72432766|NCT03499600|144378181|SUPERIORITY|||||||0.01|||||||Regression, Linear|||Analyses tested the moderation of language of service delivery and condition on session attendance.||||.01
72432767|NCT03499600|144378181|SUPERIORITY|||||||0.56|||||||Regression, Linear|||Power analysis assuming an alpha level = 0.05, beta = 0.2, and power = 0.8, identified a sample ≥82 participants was needed to identify small-to-medium effects (i.e., OR\~2.5).Intent-to-treat analyses were employed. linear regressions tested condition effects on homework completion. Due to condition differences all analyses controlled for length of intake assessment (in minutes), site, caregiver race/ethnicity, daily stress, and language of assessment delivery.||||.56
72432768|NCT03499600|144378181|SUPERIORITY||||||<|0.01|||||||Regression, Linear|||Analyses tested the moderation effect of language of service delivery and condition on homework completion.||||<.01
72432769|NCT03499600|144378181|SUPERIORITY|||||||0.4|||||||Regression, Logistic|||Power analysis assuming an alpha level = 0.05, beta = 0.2, and power = 0.8, identified a sample ≥82 participants was needed to identify small-to-medium effects (i.e., OR\~2.5).Intent-to-treat analyses were employed. Logistic regressions tested condition effects on initial session attendance. Due to condition differences all analyses controlled for length of intake assessment (in minutes), site, caregiver race/ethnicity, daily stress, and language of assessment delivery.||||.40
72432770|NCT03499600|144378181|SUPERIORITY|||||||0.01|||||||Regression, Logistic|||Analyses tested the moderation of language of service delivery and condition on initial session attendance.||||.01
72432771|NCT03499600|144378181|SUPERIORITY|||||||0.03|||||||Regression, Logistic|||power analysis assuming an alpha level = 0.05, beta = 0.2, and power = 0.8, identified a sample ≥82 participants was needed to identify small-to-medium effects (i.e., OR\~2.5).Intent-to-treat analyses were employed. A Logistic regression tested condition effects on completion of first treatment module. Due to condition differences all analyses controlled for length of intake assessment (in minutes), site, caregiver race/ethnicity, daily stress, and language of assessment delivery.||||.03
72432772|NCT03499600|144378181|SUPERIORITY|||||||0.03|||||||Regression, Logistic|||Analyses tested the moderation of language of service delivery and condition on completion of first treatment module.||||.03
72432773|NCT03499600|144378182|SUPERIORITY|Due to condition differences all analyses controlled for length of intake assessment (in minutes), site, caregiver race/ethnicity, daily stress, and language of assessment delivery.||||||0.854|||||||Regression, Linear|||A power analysis assuming an alpha level = 0.05, beta = 0.2, and power = 0.8, identified a sample ≥82 participants was needed to identify small-to-medium effects (i.e., OR\~2.5).Intent-to-treat analyses were employed. linear regressions tested condition effects on treatment satisfaction.||||.854
72432774|NCT03499600|144378183|SUPERIORITY|||||||0.319|||||||Regression, Linear|||A power analysis assuming an alpha level = 0.05, beta = 0.2, and power = 0.8, identified a sample ≥82 participants was needed to identify small-to-medium effects (i.e., OR\~2.5).Intent-to-treat analyses were employed. linear regressions tested change in ECBI score from baseline to post treatment.||||.319
72432775|NCT03425539|144378195|OTHER|An ANCOVA was applied to the change from baseline to Month 6 including the baseline value, the two stratification factors (sex and enzyme replacement therapy (ERT) treatment status), and the treatment group.|LS Mean difference vs. placebo|0.42||||0.3189|TWO_SIDED|95.0|-0.4|1.23|||ANCOVA|||||1.23|-0.4|0.3189
72432776|NCT03425539|144378196|OTHER|An ANCOVA was applied to the change from baseline to Month 6 including the baseline value, the two stratification factors (sex and ERT treatment status), and the treatment group.|LS Mean difference vs. placebo|-873.53|||<|0.0001|TWO_SIDED|95.0|-1097.53|-649.53|||ANCOVA|||||-649.53|-1097.53|<0.0001
72432777|NCT03425539|144378197|OTHER|An ANCOVA was applied to the change from baseline to Month 6 including the terms value, the two stratification factors (sex and ERT treatment status), and the treatment group.|LS Mean difference vs. placebo|0.31||||0.4676|TWO_SIDED|95.0|-0.53|1.16|||ANCOVA|||||1.16|-0.53|0.4676
72432778|NCT03425539|144378198|OTHER||Win ratio|1.0||||0.8986|TWO_SIDED|95.0|0.57|1.89|||ANCOVA|||The p-value was derived from a rank ANCOVA adjusted for the baseline value and stratified by sex and ERT treatment status.||1.89|0.57|0.8986
72432779|NCT02014558|144378217|OTHER||Slope|0.99|||||TWO_SIDED|90.0|0.788|1.19||||||Dose Proportionality (Single Dose / Day -2) was evaluated using the power model.||1.19|0.788|
72432780|NCT02014558|144378217|OTHER||Slope|1.22|||||TWO_SIDED|90.0|1.0|1.43||||||Dose Proportionality (Multiple Dose / Cycle 1 Day 15) was evaluated using the power model.||1.43|1.00|
72432781|NCT02014558|144378218|OTHER||Slope|0.808|||||TWO_SIDED|90.0|0.629|0.988||||||Dose Proportionality (Single Dose / Day -2) was evaluated using the power model.||0.988|0.629|
72432782|NCT02014558|144378218|OTHER||Slope|1.21|||||TWO_SIDED|90.0|1.02|1.41||||||Dose Proportionality (Multiple Dose / Cycle 1 Day 15) was evaluated using the power model.||1.41|1.02|
72432783|NCT02014558|144378256|OTHER||Geometric LS Mean Ratio|109.46|||||TWO_SIDED|90.0|49.82|240.48||||||Statistical Comparison of Midazolam Exposure after Administration of Midazolam Alone or Coadministered with Gilteritinib: The difference of least squares (LS) means of log-transformed pharmacokinetic parameters between midazolam alone and midazolam + gilteritinib and its 90% CI are backtransformed to the raw scale and are expressed as percent.||240.48|49.82|
72493657|NCT03048422|144516482|NON_INFERIORITY|Equivalence margin was a 10% difference between groups.|Risk Difference (RD)|-6.2||||0.12|TWO_SIDED|95.0|-13.9|1.5|||Wald test of two proportions|||||1.5|-13.9|0.12
72432784|NCT02014558|144378257|OTHER||Geometric LS Mean Ratio|149.9||||||90.0|74.88|300.06||||||Statistical Comparison of Midazolam Exposure after Administration of Midazolam Alone or Coadministered with Gilteritinib: The difference of LS means of log-transformed pharmacokinetic parameters between 1-hydroxymidazolam alone and 1-hydroxymidazolam + gilteritinib and its 90% CI are backtransformed to the raw scale and are expressed as percent.||300.06|74.88|
72432785|NCT02014558|144378258|OTHER||Geometric LS Mean Ratio|111.64|||||TWO_SIDED|90.0|69.54|179.25||||||Statistical Comparison of Midazolam Exposure after Administration of Midazolam Alone or Coadministered with Gilteritinib: The difference of LS means of log-transformed pharmacokinetic parameters between midazolam alone and midazolam + gilteritinib and its 90% CI are backtransformed to the raw scale and are expressed as percent.||179.25|69.54|
72432786|NCT02014558|144378259|OTHER||Geometric LS Mean Ratio|123.47|||||TWO_SIDED|90.0|72.41|210.52||||||Statistical Comparison of Midazolam Exposure after Administration of Midazolam Alone or Coadministered with Gilteritinib: The difference of LS means of log-transformed pharmacokinetic parameters between 1-hydroxymidazolam/midazolam alone and 1-hydroxymidazolam/midazolam + gilteritinib and its 90% CI are backtransformed to the raw scale and are expressed as percent.||210.52|72.41|
72432787|NCT02014558|144378264|OTHER||Geometric LS Mean Ratio|93.96|||||TWO_SIDED|90.0|75.29|117.26||||||Statistical Assessment of the Effect of Gilteritinib on Cephalexin Pharmacokinetics after Administration of Cephalexin Alone or Coadministered with Gilteritinib: The difference of LS means of log-transformed pharmacokinetic parameters between cephalexin alone and cephalexin + gilteritinib and its 90% CI are backtransformed to the raw scale and are expressed as percent.||117.26|75.29|
72432788|NCT02014558|144378265|OTHER||Geometric LS Mean Ratio|91.46|||||TWO_SIDED|90.0|74.6|112.12||||||Statistical Assessment of the Effect of Gilteritinib on Cephalexin Pharmacokinetics after Administration of Cephalexin Alone or Coadministered with Gilteritinib: The difference of LS means of log-transformed pharmacokinetic parameters between cephalexin alone and cephalexin + gilteritinib and its 90% CI are backtransformed to the raw scale and are expressed as percent.||112.12|74.60|
72432789|NCT02014558|144378266|OTHER||Geometric LS Mean Ratio|97.71|||||TWO_SIDED|90.0|74.19|128.7||||||Statistical Assessment of the Effect of Gilteritinib on Cephalexin Pharmacokinetics after Administration of Cephalexin Alone or Coadministered with Gilteritinib: The difference of LS means of log-transformed pharmacokinetic parameters between cephalexin alone and cephalexin + gilteritinib and its 90% CI are backtransformed to the raw scale and are expressed as percent.||128.70|74.19|
72432790|NCT02014558|144378269|OTHER||Geometric LS Mean Ratio|106.42|||||TWO_SIDED|90.0|85.28|132.81||||||Statistical Assessment of the Effect of Gilteritinib on Cephalexin Pharmacokinetics after Administration of Cephalexin Alone or Coadministered with Gilteritinib: The difference of LS means of log-transformed pharmacokinetic parameters between cephalexin alone and cephalexin + gilteritinib and its 90% CI are backtransformed to the raw scale and are expressed as percent.||132.81|85.28|
72432791|NCT02014558|144378271|OTHER||Geometric LS Mean Ratio|83.93|||||TWO_SIDED|90.0|46.53|151.39||||||Statistical Assessment of the Effect of Gilteritinib on Cephalexin Pharmacokinetics after Administration of Cephalexin Alone or Coadministered with Gilteritinib: The difference of LS means of log-transformed pharmacokinetic parameters between cephalexin alone and cephalexin + gilteritinib and its 90% CI are backtransformed to the raw scale and are expressed as percent.||151.39|46.53|
72432792|NCT02014558|144378273|OTHER||Geometric LS Mean Ratio|82.84|||||TWO_SIDED|90.0|40.25|170.48||||||Statistical Assessment of the Effect of Gilteritinib on Cephalexin Pharmacokinetics after Administration of Cephalexin Alone or Coadministered with Gilteritinib: The difference of LS means of log-transformed pharmacokinetic parameters between cephalexin alone and cephalexin + gilteritinib and its 90% CI are backtransformed to the raw scale and are expressed as percent.||170.48|40.25|
72373092|NCT01578850|144256627|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.6||||0.001|TWO_SIDED|95.0|-13.85|-3.34|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||Pain VAS: Week 36||-3.34|-13.85|0.001
72432793|NCT02449044|144378417|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||This was the p-value for analysis at Day 1.|Student's t-test|||||||<0.0001
72432794|NCT02449044|144378417|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||This was the p-value for analysis at Day 14.|Student's t-test|||||||<0.0001
72432795|NCT02449044|144378417|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||This was the p-value for analysis at Day 31.|Student's t-test|||||||<0.0001
72432796|NCT02449044|144378417|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||This was the p-value for analysis at Week 10.|Student's t-test|||||||<0.0001
72432797|NCT02449044|144378417|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||This was the p-value for analysis at Week 18.|Student's t-test|||||||<0.0001
72432798|NCT02449044|144378417|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||This was the p-value for analysis at Week 26.|Student's t-test|||||||<0.0001
72432799|NCT02449044|144378417|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||This was the p-value for analysis at Week 34.|Student's t-test|||||||<0.0001
72373093|NCT01578850|144256627|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.49|||<|0.001|TWO_SIDED|95.0|-14.72|-4.26|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||Pain VAS: Week 44||-4.26|-14.72|<0.001
72373094|NCT01578850|144256627|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.29|||<|0.001|TWO_SIDED|95.0|-14.6|-3.99|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||Pain VAS: Week 52||-3.99|-14.60|<0.001
72432800|NCT02449044|144378417|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||This was the p-value for analysis at Week 42.|Student's t-test|||||||<0.0001
72432801|NCT02449044|144378417|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||This was the p-value for analysis at Week 50.|Student's t-test|||||||<0.0001
72432802|NCT02449044|144378417|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||This was the p-value for analysis at Week 58.|Student's t-test|||||||<0.0001
72432803|NCT02449044|144378417|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||This was the p-value for analysis at Week 70.|Student's t-test|||||||<0.0001
72432804|NCT02449044|144378417|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||This was the p-value for analysis at Week 82.|Student's t-test|||||||<0.0001
72432805|NCT02449044|144378417|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||This was the p-value for analysis at Week 94.|Student's t-test|||||||<0.0001
72432806|NCT02449044|144378417|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||This was the p-value for analysis at Week 106.|Student's t-test|||||||<0.0001
72432807|NCT02449044|144378417|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||This was the p-value for analysis at Week 118.|Student's t-test|||||||<0.0001
72432808|NCT02449044|144378417|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||This was the p-value for analysis at Week 130.|Student's t-test|||||||<0.0001
72432809|NCT02449044|144378417|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||This was the p-value for analysis at Week 142.|Student's t-test|||||||<0.0001
72432810|NCT02449044|144378417|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||This was the p-value for analysis at Week 154.|Student's t-test|||||||<0.0001
72432811|NCT02449044|144378417|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||This was the p-value for analysis at Week 166.|Student's t-test|||||||<0.0001
72432812|NCT02449044|144378417|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||This was the p-value for analysis at Week 178.|Student's t-test|||||||<0.0001
72432813|NCT02449044|144378417|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||This was the p-value for analysis at Week 190.|Student's t-test|||||||<0.0001
72432814|NCT02449044|144378417|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||This was the p-value for analysis at Week 202.|Student's t-test|||||||<0.0001
72432815|NCT02449044|144378417|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||This was the p-value for analysis at Week 214.|Student's t-test|||||||<0.0001
72432816|NCT02449044|144378424|SUPERIORITY_OR_OTHER|||||||0.4922|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Day 31||||0.4922
72432817|NCT02449044|144378424|SUPERIORITY_OR_OTHER|||||||0.1054|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 10||||0.1054
72432818|NCT02449044|144378424|SUPERIORITY_OR_OTHER|||||||0.7656|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 18||||0.7656
72432819|NCT02449044|144378424|SUPERIORITY_OR_OTHER|||||||0.7084|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 26||||0.7084
72432820|NCT02449044|144378424|SUPERIORITY_OR_OTHER|||||||0.5138|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 34||||0.5138
72432821|NCT02449044|144378424|SUPERIORITY_OR_OTHER|||||||0.7175|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 42||||0.7175
72373095|NCT01578850|144256629|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.22||||0.014|TWO_SIDED|95.0|-9.39|-1.05|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||CRP: Week 28||-1.05|-9.39|0.014
72373096|NCT01578850|144256629|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.27||||0.011|TWO_SIDED|95.0|-11.09|-1.46|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||CRP: Week 36||-1.46|-11.09|0.011
72373097|NCT01578850|144256629|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.75|||<|0.001|TWO_SIDED|95.0|-12.06|-3.44|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||CRP: Week 44||-3.44|-12.06|<0.001
72432822|NCT02449044|144378424|SUPERIORITY_OR_OTHER|||||||0.354|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 50||||0.3540
72432823|NCT02449044|144378424|SUPERIORITY_OR_OTHER|||||||0.0852|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 58||||0.0852
72432824|NCT02449044|144378424|SUPERIORITY_OR_OTHER|||||||0.1923|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 70||||0.1923
72432825|NCT02449044|144378424|SUPERIORITY_OR_OTHER|||||||0.2335|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 82||||0.2335
72432826|NCT02449044|144378424|SUPERIORITY_OR_OTHER|||||||0.1346|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 94||||0.1346
72432827|NCT02449044|144378424|SUPERIORITY_OR_OTHER|||||||0.5237|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 106||||0.5237
72432828|NCT02449044|144378424|SUPERIORITY_OR_OTHER|||||||0.3476|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 118||||0.3476
72432829|NCT02449044|144378424|SUPERIORITY_OR_OTHER|||||||0.2488|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 130||||0.2488
72432830|NCT02449044|144378424|SUPERIORITY_OR_OTHER|||||||0.1598|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 142||||0.1598
72432831|NCT02449044|144378424|SUPERIORITY_OR_OTHER|||||||0.282|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 154||||0.2820
72432832|NCT02449044|144378424|SUPERIORITY_OR_OTHER|||||||0.3743|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 166||||0.3743
72432833|NCT02449044|144378424|SUPERIORITY_OR_OTHER|||||||0.36|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 178||||0.3600
72432834|NCT02449044|144378424|SUPERIORITY_OR_OTHER|||||||0.3101|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 190||||0.3101
72432835|NCT02449044|144378424|SUPERIORITY_OR_OTHER|||||||0.0269|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 202||||0.0269
72432836|NCT02449044|144378424|SUPERIORITY_OR_OTHER|||||||0.0944|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 214||||0.0944
72432837|NCT02449044|144378425|SUPERIORITY_OR_OTHER|||||||0.1739|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student t-test|||Statistical analysis at Day 14||||0.1739
72432838|NCT02449044|144378425|SUPERIORITY_OR_OTHER|||||||0.6095|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Day 31||||0.6095
72432839|NCT02449044|144378425|SUPERIORITY_OR_OTHER|||||||0.6902|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 10||||0.6902
72432840|NCT02449044|144378425|SUPERIORITY_OR_OTHER|||||||0.634|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 18||||0.6340
72432841|NCT02449044|144378425|SUPERIORITY_OR_OTHER|||||||0.321|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 26||||0.3210
72432842|NCT02449044|144378425|SUPERIORITY_OR_OTHER|||||||0.7787|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 34||||0.7787
72432843|NCT02449044|144378425|SUPERIORITY_OR_OTHER|||||||0.2198|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 42||||0.2198
72432844|NCT02449044|144378425|SUPERIORITY_OR_OTHER|||||||0.1926|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 50||||0.1926
72432845|NCT02449044|144378425|SUPERIORITY_OR_OTHER|||||||0.3109|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 58||||0.3109
72432846|NCT02449044|144378425|SUPERIORITY_OR_OTHER|||||||0.2269|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 70||||0.2269
72432847|NCT02449044|144378425|SUPERIORITY_OR_OTHER|||||||0.2749|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 82||||0.2749
72432848|NCT02449044|144378425|SUPERIORITY_OR_OTHER|||||||0.0702|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 94||||0.0702
72432849|NCT02449044|144378425|SUPERIORITY_OR_OTHER|||||||0.0412|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 106||||0.0412
72432850|NCT02449044|144378425|SUPERIORITY_OR_OTHER|||||||0.4448|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 142||||0.4448
72432851|NCT02449044|144378425|SUPERIORITY_OR_OTHER|||||||0.6233|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 166||||0.6233
72432852|NCT02449044|144378425|SUPERIORITY_OR_OTHER|||||||0.1001|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 178||||0.1001
72432853|NCT02449044|144378425|SUPERIORITY_OR_OTHER|||||||0.3739|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 190||||0.3739
72432854|NCT02449044|144378425|SUPERIORITY_OR_OTHER|||||||0.3334|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 214||||0.3334
72432855|NCT02449044|144378426|SUPERIORITY_OR_OTHER|||||||0.2575|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student t-test|||Statistical analysis at Day 14||||0.2575
72432856|NCT02449044|144378426|SUPERIORITY_OR_OTHER|||||||0.2715|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Day 31||||0.2715
72432857|NCT02449044|144378426|SUPERIORITY_OR_OTHER|||||||0.686|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 10||||0.6860
72432858|NCT02449044|144378426|SUPERIORITY_OR_OTHER|||||||0.0224|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 18||||0.0224
72432859|NCT02449044|144378426|SUPERIORITY_OR_OTHER|||||||0.1871|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 26||||0.1871
72432860|NCT02449044|144378426|SUPERIORITY_OR_OTHER|||||||0.0039|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 34||||0.0039
72432861|NCT02449044|144378426|SUPERIORITY_OR_OTHER|||||||0.0325|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 42||||0.0325
72432862|NCT02449044|144378426|SUPERIORITY_OR_OTHER|||||||0.0631|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 50||||0.0631
72432863|NCT02449044|144378426|SUPERIORITY_OR_OTHER|||||||0.0277|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 58||||0.0277
72432864|NCT02449044|144378426|SUPERIORITY_OR_OTHER|||||||0.0128|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 70||||0.0128
72432865|NCT02449044|144378426|SUPERIORITY_OR_OTHER|||||||0.0164|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 82||||0.0164
72432866|NCT02449044|144378426|SUPERIORITY_OR_OTHER|||||||0.0119|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 94||||0.0119
72432867|NCT02449044|144378426|SUPERIORITY_OR_OTHER|||||||0.0013|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 106||||0.0013
72432868|NCT02449044|144378426|SUPERIORITY_OR_OTHER|||||||0.6691|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 142||||0.6691
72432869|NCT02449044|144378426|SUPERIORITY_OR_OTHER|||||||0.6923|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 166||||0.6923
72432870|NCT02449044|144378426|SUPERIORITY_OR_OTHER|||||||0.9292|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 178||||0.9292
72373098|NCT01578850|144256629|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.16||||0.001|TWO_SIDED|95.0|-11.48|-2.85|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||CRP: Week 52||-2.85|-11.48|0.001
72373099|NCT01578850|144256629|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.86|||<|0.001|TWO_SIDED|95.0|-9.23|-2.49|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||ESR: Week 28||-2.49|-9.23|<0.001
72373100|NCT01578850|144256629|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.69|||<|0.001|TWO_SIDED|95.0|-12.33|-5.05|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||ESR: Week 36||-5.05|-12.33|<0.001
72373101|NCT01578850|144256629|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.59|||<|0.001|TWO_SIDED|95.0|-11.38|-3.8|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||ESR: Week 44||-3.80|-11.38|<0.001
72373102|NCT01578850|144256629|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.32|||<|0.001|TWO_SIDED|95.0|-10.03|-2.6|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||ESR: Week 52||-2.60|-10.03|<0.001
72373103|NCT02744040|144256631|OTHER|||||||0.048||||||Multiple hypothesis testing was performed using Tukey's Honest Significant Difference (HSD) procedure.|Mixed Effects Models|||Total HIV DNA at the time of ART initiation in each of the three EDDI groups||||0.048
72373104|NCT02744040|144256632|OTHER|Tukey's Honest Significant Difference (HSD) test|||||<|0.0001||||||Pair-wise comparison of Slope 1|Tukey's Honest Significant Difference (H|||The decay in total HIV DNA was modeled from the time of ART initiation in each of the three EDDI groups until the end of follow-up. The decay was analyzed on the log10 scale with a mixed-effects model to account for correlation between measurements from the same individual. We used a piecewise linear function to model the decay, where the number of linear segments was fixed at 2 (two-phase segmentation model) for Total HIV DNA.||||<0.0001
72373105|NCT02744040|144256632|OTHER|Tukey's Honest Significant Difference (HSD) test|||||<|0.0001||||||Pair-wise comparison of Slope 1|Tukey's Honest Significant Difference (H|||The decay in total HIV DNA was modeled from the time of ART initiation in each of the three EDDI groups until the end of follow-up. The decay was analyzed on the log10 scale with a mixed-effects model to account for correlation between measurements from the same individual. We used a piecewise linear function to model the decay, where the number of linear segments was fixed at 2 (two-phase segmentation model) for Total HIV DNA.||||<0.0001
72373106|NCT02744040|144256632|OTHER|Tukey's Honest Significant Difference (HSD) test|||||<|0.0001||||||Pair-wise comparison of Slope 1|Tukey's Honest Significant Difference (H|||The decay in total HIV DNA was modeled from the time of ART initiation in each of the three EDDI groups until the end of follow-up. The decay was analyzed on the log10 scale with a mixed-effects model to account for correlation between measurements from the same individual. We used a piecewise linear function to model the decay, where the number of linear segments was fixed at 2 (two-phase segmentation model) for Total HIV DNA.||||<0.0001
72432871|NCT02449044|144378426|SUPERIORITY_OR_OTHER|||||||0.4401|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 190||||0.4401
72432872|NCT02449044|144378426|SUPERIORITY_OR_OTHER|||||||0.3609|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 214||||0.3609
72373107|NCT02744040|144256632|OTHER|Tukey's Honest Significant Difference (HSD) test|||||<|0.0001||||||Pair-Wise comparison of Slope 2|Tukey's Honest Significant Difference (H|||The decay in total HIV DNA was modeled from the time of ART initiation in each of the three EDDI groups until the end of follow-up. The decay was analyzed on the log10 scale with a mixed-effects model to account for correlation between measurements from the same individual. We used a piecewise linear function to model the decay, where the number of linear segments was fixed at 2 (two-phase segmentation model) for Total HIV DNA.||||<0.0001
72373108|NCT02744040|144256632|OTHER|Tukey's Honest Significant Difference (HSD) test|||||<|0.0001||||||Pair-Wise comparison of Slope 2|Tukey's Honest Significant Difference (H|||The decay in total HIV DNA was modeled from the time of ART initiation in each of the three EDDI groups until the end of follow-up. The decay was analyzed on the log10 scale with a mixed-effects model to account for correlation between measurements from the same individual. We used a piecewise linear function to model the decay, where the number of linear segments was fixed at 2 (two-phase segmentation model) for Total HIV DNA.||||<0.0001
72373109|NCT02744040|144256632|OTHER|Tukey's Honest Significant Difference (HSD) test|||||<|0.0001||||||Pair-Wise comparison of Slope 2|Tukey's Honest Significant Difference (H|||The decay in total HIV DNA was modeled from the time of ART initiation in each of the three EDDI groups until the end of follow-up. The decay was analyzed on the log10 scale with a mixed-effects model to account for correlation between measurements from the same individual. We used a piecewise linear function to model the decay, where the number of linear segments was fixed at 2 (two-phase segmentation model) for Total HIV DNA.||||<0.0001
72373110|NCT02744040|144256633|OTHER||||||>|0.05||||||Multiple hypothesis testing was performed using Tukey's HSD procedure.|Mixed Effects Models|||Integrated HIV DNA at the time of ART initiation in each of the three EDDI groups||||>0.05
72373111|NCT02744040|144256634|OTHER|Tukey's Honest Significant Difference (HSD) test|||||<|0.0001||||||Pair-Wise comparison of Slope 1|Tukey's Honest Significant Difference (H|||The decay in integrated HIV DNA was modeled from the time of ART initiation in each of the three EDDI groups until the end of follow-up. The decay was analyzed on the log10 scale with a mixed-effects model to account for correlation between measurements from the same individual. We used a piecewise linear function to model the decay, where the number of linear segments was fixed at 2 (two-phase segmentation model) for integrated HIV DNA.||||<0.0001
72432873|NCT05541497|144378428|SUPERIORITY||Risk Ratio (RR)|1.51|||||TWO_SIDED|95.0|0.68|3.37||||||||3.37|0.68|
72432874|NCT05541497|144378429|SUPERIORITY||Risk Ratio (RR)|1.36|||||TWO_SIDED|95.0|0.59|3.13||||||||3.13|0.59|
72432875|NCT00587288|144378430|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.38|STANDARD_ERROR_OF_MEAN|0.194||0.0541|TWO_SIDED|95.0|-0.76|0.01||The p-value for the treatment comparison is based on the ANCOVA with adjustment for stratification factor and for variable at baseline.|ANCOVA|||||0.01|-0.76|0.0541
72373112|NCT02744040|144256634|OTHER|Tukey's Honest Significant Difference (HSD) test|||||<|0.0001||||||Pair-Wise comparison of Slope 1|Tukey's Honest Significant Difference (H|||The decay in integrated HIV DNA was modeled from the time of ART initiation in each of the three EDDI groups until the end of follow-up. The decay was analyzed on the log10 scale with a mixed-effects model to account for correlation between measurements from the same individual. We used a piecewise linear function to model the decay, where the number of linear segments was fixed at 2 (two-phase segmentation model) for integrated HIV DNA.||||<0.0001
72373113|NCT02744040|144256634|OTHER|Tukey's Honest Significant Difference (HSD) test|||||<|0.0001||||||Pair-Wise comparison of Slope 1|Tukey's Honest Significant Difference (H|||The decay in integrated HIV DNA was modeled from the time of ART initiation in each of the three EDDI groups until the end of follow-up. The decay was analyzed on the log10 scale with a mixed-effects model to account for correlation between measurements from the same individual. We used a piecewise linear function to model the decay, where the number of linear segments was fixed at 2 (two-phase segmentation model) for integrated HIV DNA.||||<0.0001
72373114|NCT02744040|144256634|OTHER|Tukey's Honest Significant Difference (HSD) test|||||>|0.05||||||Pair-Wise comparison of Slope 2|Tukey's Honest Significant Difference (H|||The decay in integrated HIV DNA was modeled from the time of ART initiation in each of the three EDDI groups until the end of follow-up. The decay was analyzed on the log10 scale with a mixed-effects model to account for correlation between measurements from the same individual. We used a piecewise linear function to model the decay, where the number of linear segments was fixed at 2 (two-phase segmentation model) for integrated HIV DNA.||||>0.05
72373115|NCT02744040|144256634|OTHER|Tukey's Honest Significant Difference (HSD) test|||||>|0.05||||||Pair-Wise comparison of Slope 2|Tukey's Honest Significant Difference (H|||The decay in integrated HIV DNA was modeled from the time of ART initiation in each of the three EDDI groups until the end of follow-up. The decay was analyzed on the log10 scale with a mixed-effects model to account for correlation between measurements from the same individual. We used a piecewise linear function to model the decay, where the number of linear segments was fixed at 2 (two-phase segmentation model) for integrated HIV DNA.||||>0.05
72373116|NCT02744040|144256634|OTHER|Tukey's Honest Significant Difference (HSD) test|||||>|0.05||||||Pair-Wise comparison of Slope 2|Tukey's Honest Significant Difference (H|||The decay in integrated HIV DNA was modeled from the time of ART initiation in each of the three EDDI groups until the end of follow-up. The decay was analyzed on the log10 scale with a mixed-effects model to account for correlation between measurements from the same individual. We used a piecewise linear function to model the decay, where the number of linear segments was fixed at 2 (two-phase segmentation model) for integrated HIV DNA.||||>0.05
72373117|NCT02744040|144256635|OTHER|||||||0.057||||||Multiple hypothesis testing was performed using Tukey's HSD procedure.|Mixed Effects Models|||TILDA stimulation reservoir measure at the time of ART initiation in each of the three EDDI groups||||0.057
72373118|NCT02744040|144256636|OTHER|Tukey's Honest Significant Difference (HSD) test||||||0.01||||||Pair-Wise comparison of Slope 1|Tukey's Honest Significant Difference (H|||The decay in TILDA stimulation was modeled from the time of ART initiation in each of the three EDDI groups until the end of follow-up. The decay was analyzed on the log10 scale with a mixed-effects model to account for correlation between measurements from the same individual. We used a piecewise linear function to model the decay, where the number of linear segments was fixed at 2 (two-phase segmentation model) for TILDA Stimulation.||||0.010
72373119|NCT02744040|144256636|OTHER|Tukey's Honest Significant Difference (HSD) test|||||<|0.0001||||||Pair-Wise comparison of Slope 1|Tukey's Honest Significant Difference (H|||The decay in TILDA stimulation was modeled from the time of ART initiation in each of the three EDDI groups until the end of follow-up. The decay was analyzed on the log10 scale with a mixed-effects model to account for correlation between measurements from the same individual. We used a piecewise linear function to model the decay, where the number of linear segments was fixed at 2 (two-phase segmentation model) for TILDA Stimulation.||||<0.0001
72373120|NCT02744040|144256636|OTHER|Tukey's Honest Significant Difference (HSD) test|||||>|0.05||||||Pair-Wise comparison of Slope 1|Tukey's Honest Significant Difference (H|||The decay in TILDA stimulation was modeled from the time of ART initiation in each of the three EDDI groups until the end of follow-up. The decay was analyzed on the log10 scale with a mixed-effects model to account for correlation between measurements from the same individual. We used a piecewise linear function to model the decay, where the number of linear segments was fixed at 2 (two-phase segmentation model) for TILDA Stimulation.||||>0.05
72373121|NCT02744040|144256636|OTHER|Tukey's Honest Significant Difference (HSD) test|||||>|0.05||||||Pair-Wise comparison of Slope 2|Tukey's Honest Significant Difference (H|||The decay in TILDA stimulation was modeled from the time of ART initiation in each of the three EDDI groups until the end of follow-up. The decay was analyzed on the log10 scale with a mixed-effects model to account for correlation between measurements from the same individual. We used a piecewise linear function to model the decay, where the number of linear segments was fixed at 2 (two-phase segmentation model) for TILDA Stimulation.||||>0.05
72373122|NCT02744040|144256636|OTHER|Tukey's Honest Significant Difference (HSD) test||||||0.052||||||Pair-Wise comparison of Slope 2|Tukey's Honest Significant Difference (H|||The decay in TILDA stimulation was modeled from the time of ART initiation in each of the three EDDI groups until the end of follow-up. The decay was analyzed on the log10 scale with a mixed-effects model to account for correlation between measurements from the same individual. We used a piecewise linear function to model the decay, where the number of linear segments was fixed at 2 (two-phase segmentation model) for TILDA Stimulation.||||0.052
72373123|NCT02744040|144256636|OTHER|Tukey's Honest Significant Difference (HSD) test|||||>|0.05||||||Pair-Wise comparison of Slope 2|Tukey's Honest Significant Difference (H|||The decay in TILDA stimulation was modeled from the time of ART initiation in each of the three EDDI groups until the end of follow-up. The decay was analyzed on the log10 scale with a mixed-effects model to account for correlation between measurements from the same individual. We used a piecewise linear function to model the decay, where the number of linear segments was fixed at 2 (two-phase segmentation model) for TILDA Stimulation.||||>0.05
72432876|NCT00587288|144378431|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.01||||0.0848|TWO_SIDED|95.0|0.91|4.46||The p-value for the treatment comparison was based on logistic regression with adjustment for stratification factor.|Regression, Logistic|||||4.46|0.91|0.0848
72432877|NCT00587288|144378432|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.24|STANDARD_ERROR_OF_MEAN|0.077||0.0023|TWO_SIDED|95.0|0.088|0.392||The p-value for the treatment comparison was based on the ANCOVA with adjustment for stratification factor and for variable at baseline.|ANCOVA|||||0.392|0.088|0.0023
72373124|NCT00096356|144256644|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.37|STANDARD_ERROR_OF_MEAN|1.03||0.1815|TWO_SIDED|95.0|-3.39|0.64||The a priori significance level was 0.05 for the primary outcome; there is no adjustment for multiple comparisons.|Mixed Models Analysis||This is the estimate of the difference in arms (Co-Q10 minus placebo). Lower is better for this outcome.|Constrained repeated measures analysis of variance - constrained such that baseline fatigue was the same in both groups and unadjusted for any baseline covariates.||0.64|-3.39|0.1815
72373125|NCT00096356|144256645|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.99|STANDARD_ERROR_OF_MEAN|2.31||0.3903|TWO_SIDED|95.0|-2.56|6.53||0.05 significance level; no multiple comparison adjustment|Mixed Models Analysis||This is the difference in treatment groups at 24 weeks (Co-Q10 minus Placebo). Higher is better for this outcome.|Constrained repeated measures analysis of variance - constrained to have equal means at baseline, unadjusted for other covariates||6.53|-2.56|.3903
72373126|NCT00096356|144256646|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.68|STANDARD_ERROR_OF_MEAN|1.31||0.6014|TWO_SIDED|95.0|-3.25|1.88||0.05 significance level, unadjusted for multiple comparisons|Mixed Models Analysis||This is the difference between treatment groups at 24 weeks (Co-Q10 minus Placebo). Lower is better for this outcome.|Constrained repeated measures analysis of variance, constrained such that the baseline means are equal, unadjusted of other covariates||1.88|-3.25|.6014
72373127|NCT01809639|144256647|SUPERIORITY_OR_OTHER|||||||0.42|||||||ANOVA|||||||.42
72373128|NCT03698591|144256676|OTHER||F-statistic|6.155||||0.019|TWO_SIDED|||||P-value corresponds to 3 way interaction. A priori significance threshold of p \< .05.|ANOVA|||The null hypothesis was that distancing performance would not differ by arm of the study. Within-subjects factors included task condition (distancing vs. distraction) and study arm. Study arm order was used as a between-subjects factor.||||.019
72373129|NCT03698591|144256676|OTHER||F-statistic|5.911||||0.021|TWO_SIDED|||||P-value corresponds to two-way interaction. A priori significance threshold of p \< .05.|ANOVA|||This analysis evaluated the two-way interaction of task condition and study period. The null hypothesis was that distancing performance would not differ by study period. Within-subjects factors included task condition and study period.||||.021
72373130|NCT03698591|144256676|OTHER||t-statistic|-1.656||||0.108|TWO_SIDED|||||A priori significance threshold of p \< .05.|t-test, 2 sided|||A dependent-samples t-test was used to compare distancing performance between study periods 1 and 2. The null hypothesis was that distancing performance would not differ by study period.||||.108
72373131|NCT03698591|144256676|OTHER||F-statistic|0.004||||0.948|TWO_SIDED|||||A priori threshold of p \< .05. This value reflects the test of the main effect of study arm.|ANOVA|||For this analysis, study arm and task condition were used as within-subjects factors, study arm order was used as a between-subjects factor, and TMS stimulator intensity and brain-target-to-scalp distance were used as covariates.||||.948
72373132|NCT03698591|144256677|OTHER||F-statistic|0.031||||0.862|TWO_SIDED|||||P-value corresponds to the two way interaction of task condition and study arm . A priori significance threshold of p \< .05.|ANOVA|||The null hypothesis was that distancing self-reported effort would not differ by arm of the study. Within-subjects factors included task condition (distancing vs. distraction) and study arm. Study arm order was used as a between-subjects factor.||||.862
72373133|NCT03698591|144256677|OTHER||F-statistic|4.04||||0.054|TWO_SIDED|||||P-value corresponds to the main effect of study period. A priori threshold of p \< .05.|ANOVA|||A follow-up ANOVA was run with within-subjects factors of task condition and study period.||||.054
72373134|NCT03698591|144256677|OTHER||t-statistic|2.694||||0.012|TWO_SIDED|||||A priori significance threshold of p \< .05.|t-test, 2 sided|||A follow-up dependent-samples t-test was run to test a potential effect of study period on distancing effort.||||.012
72432878|NCT00587288|144378433|SUPERIORITY_OR_OTHER||Adjusted mean difference|7.98|STANDARD_ERROR_OF_MEAN|2.36||0.001|TWO_SIDED|95.0|3.3|12.65||The p-value for the treatment comparison was based on the ANCOVA with adjustment for stratification factor and for variable at baseline.|ANCOVA|||||12.65|3.30|0.0010
72432879|NCT00587288|144378434|SUPERIORITY_OR_OTHER||Adjusted mean difference|-125.29|STANDARD_ERROR_OF_MEAN|44.885||0.0068|TWO_SIDED|95.0|-214.81|-35.77||The p-value for the treatment comparison was based on the ANCOVA with adjustment for stratification factor and for variable at baseline. The difference between reslizumab 3.0 mg/kg and placebo groups was from comparison of the least square means.|ANCOVA|||||-35.77|-214.81|0.0068
72432880|NCT00587288|144378435|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.33||||0.0833|TWO_SIDED|95.0|0.1|1.15||The p-value for the treatment comparison was based on logistic regression with adjustment for stratification factor.|Regression, Logistic|||||1.15|0.10|0.0833
72373135|NCT03698591|144256677|OTHER||F-statistic|3.196||||0.085|TWO_SIDED|||||A priori threshold of p \< .05. This value reflects the test of the main effect of study arm.|ANOVA|||Post-hoc analyses were used to explore treatment effects using covariates related to the treatment parameters. For this analysis, study arm and task condition were used as within-subjects factors, study arm order was used as a between-subjects factor, and TMS stimulator intensity and brain-target-to-scalp distance were used as covariates.||||.085
72373136|NCT03698591|144256677|OTHER||F-statistic|7.162||||0.013|TWO_SIDED|||||A priori threshold of p \< .05. This value reflects the test of the main effect of study arm.|ANOVA|||This analysis examined the effect of study arm specifically on distancing effort. The within-subjects factor was study arm, between-subjects factor was study arm order, and TMS stimulator intensity and brain-target-to-scalp distance were used as covariates.||||.013
72373137|NCT03698591|144256678|OTHER||F-statistic|6.155||||0.019|TWO_SIDED|||||P-value corresponds to 3 way interaction. A priori significance threshold of p \< .05.|ANOVA|||The null hypothesis was that distraction performance would not differ by arm of the study. Within-subjects factors included task condition (distancing vs. distraction) and study arm. Study arm order was used as a between-subjects factor.||||.019
72373138|NCT03698591|144256678|OTHER||F-statistic|5.911||||0.021|TWO_SIDED|||||P-value corresponds to two-way interaction. A priori significance threshold of p \< .05.|ANOVA|||This analysis evaluated the two-way interaction of task condition and study period. The null hypothesis was that distraction performance would not differ by study period. Within-subjects factors included task condition and study period.||||.021
72373139|NCT03698591|144256678|OTHER||t-statistic|1.282||||0.21|TWO_SIDED|||||A priori significance threshold of p \< .05.|t-test, 2 sided|||A dependent-samples t-test was used to compare distraction performance between study periods 1 and 2. The null hypothesis was that distraction performance would not differ by study period.||||.210
72373140|NCT03698591|144256678|OTHER||F-statistic|0.004||||0.948|TWO_SIDED|||||A priori threshold of p \< .05. This value reflects the test of the main effect of study arm.|ANOVA|||Post-hoc analyses were used to explore treatment effects using covariates related to the treatment parameters. For this analysis, study arm and task condition were used as within-subjects factors, study arm order was used as a between-subjects factor, and TMS stimulator intensity and brain-target-to-scalp distance were used as covariates.||||.948
72373141|NCT03698591|144256679|OTHER||F-statistic|0.031||||0.862|TWO_SIDED|||||P-value corresponds to the two way interaction of task condition and study arm . A priori significance threshold of p \< .05.|ANOVA|||The null hypothesis was that distraction self-reported effort would not differ by arm of the study. Within-subjects factors included task condition (distancing vs. distraction) and study arm. Study arm order was used as a between-subjects factor.||||.862
72373142|NCT03698591|144256679|OTHER||F-statistic|4.04||||0.054|TWO_SIDED|||||P-value corresponds to the main effect of study period. A priori threshold of p \< .05.|ANOVA|||A follow-up ANOVA was run with within-subjects factors of task condition and study period.||||.054
72373143|NCT03698591|144256679|OTHER||t-statistic|0.828||||0.415|TWO_SIDED|||||A priori significance threshold of p \< .05.|t-test, 2 sided|||A follow-up dependent-samples t-test was run to test the effect of study period on distraction effort.||||.415
72373144|NCT03698591|144256679|OTHER||F-statistic|3.196||||0.085|TWO_SIDED|||||A priori threshold of p \< .05. This value reflects the test of the main effect of study arm.|ANOVA|||Post-hoc analyses were used to explore treatment effects using covariates related to the treatment parameters. For this analysis, study arm and task condition were used as within-subjects factors, study arm order was used as a between-subjects factor, and TMS stimulator intensity and brain-target-to-scalp distance were used as covariates.||||.085
72373145|NCT03698591|144256679|OTHER||F-statistic|0.396||||0.535|TWO_SIDED|||||A priori threshold of p \< .05. This value reflects the test of the main effect of study arm.|ANOVA|||This analysis examined the effect of study arm specifically on distraction performance. The within-subjects factor was study arm, between-subjects factor was study arm order, and TMS stimulator intensity and brain-target-to-scalp distance were used as covariates.||||.535
72373146|NCT01675167|144256717|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.98|||<|1e-05|TWO_SIDED|95.0|-1.32|-0.64||P value was adjusted using weighted z-test (CHW).|ANCOVA|||||-0.64|-1.32|<.00001
72373147|NCT01675167|144256718|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by stratum (dose level)||Responders with ≥30% pain reduction||||<.0001
72373148|NCT01675167|144256718|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by Stratum (Dose Level)||Responders with ≥50% pain reduction||||<.0001
72373149|NCT01379508|144256748|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was derived if the lower limit of two-sided 95% CI for the difference lied above the pre-determined non-inferiority margin (-10%).|Difference in percentage|-4.0|||||TWO_SIDED|95.0|-10.5|2.5||||||Missing DNA data at Wk 52=failure: To evaluate the primary objective, Mantel-Haenszel weighted estimates approach (stratified by HBV DNA level (\< 7 log10 copies/mL or ≥ 7 log10 copies/mL) and ALT (\< 3×ULN or ≥ 3×ULN) at baseline) was employed to assess the proportion of patients (response rate) who achieve HBV DNA \< 300 copies/mL after 52 weeks treatment in each treatment arm, as well as the difference in proportions (telbivudine - tenofovir arm) and the 95% CI of the difference.||2.5|-10.5|
72373150|NCT01379508|144256748|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was derived if the lower limit of two-sided 95% CI for the difference was above the pre-determined non-inferiority margin (-10%).|Difference in percentage|-3.1|||||TWO_SIDED|95.0|-9.4|3.1||||||Imputing +/- 7 days DNA for Wk 52: To evaluate the primary objective, Mantel-Haenszel weighted estimates approach (stratified by HBV DNA level (\< 7 log10 copies/mL or ≥ 7 log10 copies/mL) and ALT (\< 3×ULN or ≥ 3×ULN) at baseline) was employed to assess the proportion of patients (response rate) who achieve HBV DNA \< 300 copies/mL after 52 weeks treatment in each treatment arm, as well as the difference in proportions (telbivudine - tenofovir arm) and the 95% CI of the difference.||3.1|-9.4|
72373151|NCT01379508|144256748|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was derived if the lower limit of two-sided 95% CI for the difference lied above the pre-determined non-inferiority margin (-10%).|Difference in percentage|-3.8|||||TWO_SIDED|95.0|-7.9|0.4||||||Imputing LOCF DNA for wk 52: d/c for non response prior to Wk 52: Treating missing as failure for patients who discontinued prior to Week 52 due to unsatisfactory therapeutic effect and imputing missing with LOCF for other patients||0.4|-7.9|
72373152|NCT01379508|144256748|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was derived if the lower limit of two-sided 95% CI for the difference lied above the pre-determined non-inferiority margin (-10%).|Difference in percentage|-2.3|||||TWO_SIDED|95.0|-8.3|3.8||||||Imputing within +28d DNA for wk52: d/c for non response \<28 days from Wk 52:Treating missing as failure for patients who discontinued prior to Week 52 due to unsatisfactory therapeutic effect and imputing missing with the earliest available assessment within the 28-day window starting from the scheduled Week 52 date for other patients (if no such assessment is available, treated as failure)||3.8|-8.3|
72373153|NCT01457352|144256752|SUPERIORITY|||||||0.2062|||||||Cochran-Mantel-Haenszel|||||||0.2062
72373154|NCT01457352|144256753|SUPERIORITY|||||||0.0485|||||||Mantel Haenszel|||||||0.0485
72373155|NCT04174365|144256760|SUPERIORITY||Least squares (LS) mean difference|-1.22||||0.4597|TWO_SIDED|95.0|-4.49|2.05|||Mixed model repeated measures(MMRM)|MMRM method with model terms: treatment, trial site, baseline body weight stratum, visit, treatment-by-visit and baseline-by-visit interaction.|MMRM method with model terms: treatment, trial site, baseline body weight stratum, visit, treatment-by-visit and baseline-by-visit interaction. Significance test was based on least-square means using a two-sided 0.05 level.|||2.05|-4.49|0.4597
72373156|NCT04174365|144256761|SUPERIORITY||LS mean difference|-0.07||||0.7315|TWO_SIDED|95.0|-0.46|0.32|||MMRM|MMRM method with model terms: treatment, trial site, baseline body weight stratum, visit, treatment-by-visit and baseline-by-visit interaction.|MMRM method with model terms: treatment, trial site, baseline body weight stratum, visit, treatment-by-visit and baseline-by-visit interaction. Significance test was based on least-square means using a two-sided 0.05 level.|||0.32|-0.46|0.7315
72373157|NCT02522624|144256912|SUPERIORITY_OR_OTHER||||||<|0.001||||||A priori sample size estimates yielded an estimate of 183 per group needed to detect an effect size of 0.34 with 90% power at a 0.05 level of significance and 137 per group with 80% power.|Regression, Linear|||||||<.001
72493658|NCT03048422|144516482|NON_INFERIORITY|Equivalence margin was a 10% difference between groups.|Risk Difference (RD)|2.0||||0.63|TWO_SIDED|95.0|-6.0|10.0|||Wald test of two proportions|||||10.0|-6.0|0.63
72432881|NCT00587288|144378435|SUPERIORITY_OR_OTHER|||||||0.0809|||||||Log Rank|The p value for the treatment comparison was based on log rank test adjusting for stratification factor (ie, ACQ score ≤2 and \>2).||"Kaplan-Meier estimate of time to first CAE. (First quartile, median and third quartile survival times with 95% confidence intervals (ie, time to first CAE) could not be estimated since the proportion of patients experiencing CAE was too low. Therefore, the only number presented in regard to the Kaplan-Meier analysis is the p-value of the log-rank test, below. )"||||0.0809
72432882|NCT02072226|144378467|OTHER|Confidence Interval|Adjusted Risk Difference|-1.1|||||TWO_SIDED|95.0|-9.44|7.25||||||||7.25|-9.44|
72432883|NCT02072226|144378468|OTHER|Confidence Interval|Odds Ratio (OR)|0.81|||||TWO_SIDED|95.0|0.527|1.244||||||||1.244|0.527|
72432884|NCT02072226|144378469|OTHER|Confidence Interval|Odds Ratio (OR)|0.858|||||TWO_SIDED|95.0|0.529|1.393||||||||1.393|0.529|
72432885|NCT02072226|144378470|OTHER|Confidence Interval|difference in percentages|3.25|||||TWO_SIDED|95.0|0.75|7.38||||||||7.38|0.75|
72432886|NCT02072226|144378471|OTHER|Confidence Interval|difference in percentages|4.53|||||TWO_SIDED|95.0|-0.34|10.07||||||Any ICH within 36 hours reported by site||10.07|-0.34|
72432887|NCT02072226|144378471|OTHER|Confidence Interval|difference in percentages|3.87|||||TWO_SIDED|95.0|-1.23|9.49||||||Any ICH within 36 hours reported by central reader||9.49|-1.23|
72432888|NCT00810303|144378482|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Wilcoxon (Mann-Whitney)|||Paired Wilcoxon-test between free ezetimibe alone and free ezetimibe with single dose treatment of efavirenz.||||<0.05
72432889|NCT00810303|144378483|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Wilcoxon (Mann-Whitney)|||Paired Wilcoxon-test between free ezetimibe alone and free ezetimibe with single dose treatment of efavirenz.||||<0.05
72432890|NCT00810303|144378485|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Wilcoxon (Mann-Whitney)|||Paired Wilcoxon-test between steady state pharmakokinetic of efavirenz with chronic treatment of ezetimibe and the single dose pharmakokinetic of efavirenz without chronic treatment of ezetimibe.||||<0.05
72432891|NCT00810303|144378486|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Wilcoxon (Mann-Whitney)|||Paired Wilcoxon-test between steady state pharmakokinetic of efavirenz with chronic treatment of ezetimibe and the single dose pharmakokinetic of efavirenz with chronic treatment of ezetimibe.||||<0.05
72432892|NCT00810303|144378487|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Wilcoxon (Mann-Whitney)|||Paired Wilcoxon-test between steady state pharmakokinetic of efavirenz with chronic treatment of ezetimibe and the single dose pharmakokinetic of efavirenz without chronic treatment of ezetimibe.||||<0.05
72432893|NCT00810303|144378487|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Wilcoxon (Mann-Whitney)|||Paired Wilcoxon-test between steady state pharmakokinetic of efavirenz with chronic treatment of ezetimibe and the single dose pharmakokinetic of efavirenz with chronic treatment of ezetimibe.||||<0.05
72432894|NCT00810303|144378488|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Wilcoxon (Mann-Whitney)|||Paired Wilcoxon-test between steady state pharmakokinetic of efavirenz with chronic treatment of ezetimibe and the single dose pharmakokinetic of efavirenz without chronic treatment of ezetimibe.||||<0.05
72432895|NCT00810303|144378489|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Wilcoxon (Mann-Whitney)|||Paired Wilcoxon-test between steady state pharmakokinetic of efavirenz with chronic treatment of ezetimibe and the single dose pharmakokinetics of efavirenz with chronic treatment of ezetimibe.||||<0.05
72432896|NCT00810303|144378490|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Wilcoxon (Mann-Whitney)|||Paired Wilcoxon-test between steady state pharmakokinetic of efavirenz with chronic treatment of ezetimibe and the single dose pharmakokinetic of efavirenz without chronic treatment of ezetimibe.||||<0.05
72432897|NCT00810303|144378490|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Wilcoxon (Mann-Whitney)|||Paired Wilcoxon-test between steady state pharmakokinetic of efavirenz with chronic treatment of ezetimibe and the single dose pharmakokinetics of efavirenz with chronic treatment of ezetimibe.||||<0.05
72432898|NCT00810303|144378491|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Wilcoxon (Mann-Whitney)|||Paired Wilcoxon-test between free ezetimibe alone and free ezetimibe with single dose treatment of efavirenz.||||<0.05
72432899|NCT00810303|144378491|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Wilcoxon (Mann-Whitney)|||Paired Wilcoxon-test between free ezetimibe with chronic treatment of efavirenz and free ezetimibe alone.||||<0.05
72432900|NCT00810303|144378492|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Wilcoxon (Mann-Whitney)|||Paired Wilcoxon-test between free ezetimibe alone and free ezetimibe with single dose treatment of efavirenz.||||<0.05
72432901|NCT00810303|144378492|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Wilcoxon (Mann-Whitney)|||Paired Wilcoxon-test between free ezetimibe with chronic treatment of efavirenz and free ezetimibe with single dose treatment of efavirenz.||||<0.05
72432902|NCT00810303|144378493|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Wilcoxon (Mann-Whitney)|||Paired Wilcoxon-test between free ezetimibe with chronic treatment of efavirenz and free ezetimibe alone.||||<0.05
72432903|NCT00810303|144378493|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Wilcoxon (Mann-Whitney)|||Paired Wilcoxon-test between free ezetimibe with chronic treatment of efavirenz and free ezetimibe with single dose treatment of efavirenz.||||<0.05
72432904|NCT00810303|144378494|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Wilcoxon (Mann-Whitney)|||Paired Wilcoxon-test between free ezetimibe with chronic treatment of efavirenz and free ezetimibe alone.||||<0.05
72432905|NCT00810303|144378495|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Wilcoxon (Mann-Whitney)|||Paired Wilcoxon-test between free ezetimibe with chronic treatment of efavirenz and free ezetimibe with single dose treatment of efavirenz.||||<0.05
72432906|NCT00810303|144378496|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Wilcoxon (Mann-Whitney)|||Paired Wilcoxon-test between free ezetimibe with chronic treatment of efavirenz and free ezetimibe alone.||||<0.05
72432907|NCT00810303|144378496|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Wilcoxon (Mann-Whitney)|||Paired Wilcoxon-test between free ezetimibe with chronic treatment of efavirenz and free ezetimibe with single dose treatment of efavirenz.||||<0.05
72432908|NCT01124162|144378498|NON_INFERIORITY_OR_EQUIVALENCE|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level.|Ratio of the T/R geometric mean x 100|108.14|||||TWO_SIDED|90.0|97.43|120.03|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||120.03|97.43|
72493659|NCT03048422|144516482|NON_INFERIORITY|Equivalence margin was a 10% difference between groups.|Risk Difference (RD)|-4.2||||0.28|TWO_SIDED|95.0|-11.7|3.4|||Wald test of two proportions|||||3.4|-11.7|0.28
72373158|NCT02522624|144256912|SUPERIORITY_OR_OTHER|||||||0.16||||||A priori sample size estimates yielded an estimate of 183 per group needed to detect an effect size of 0.34 with 90% power at a 0.05 level of significance and 137 per group with 80% power.|Regression, Linear|||Examined the relation between group and categorical outcomes, controlling for % Federal Poverty Level (400 or greater, 250-399, 100-249, less than 100).||||0.16
72373159|NCT02522624|144256912|SUPERIORITY_OR_OTHER||||||<|0.001||||||A priori sample size estimates yielded an estimate of 183 per group needed to detect an effect size of 0.34 with 90% power at a 0.05 level of significance and 137 per group with 80% power.|Regression, Linear|||Controlling for Numeracy.||||<.001
72373160|NCT02522624|144256913|SUPERIORITY_OR_OTHER|||||||0.002||||||A priori sample size estimates yielded an estimate of 183 per group needed to detect an effect size of 0.34 with 90% power at a 0.05 level of significance and 137 per group with 80% power.|Regression, Linear|||||||0.002
72373161|NCT02522624|144256913|SUPERIORITY_OR_OTHER|||||||0.3|||||||Regression, Linear|||Examined the relation between group and categorical outcomes, controlling for % Federal Poverty Level (400 or greater, 250-399, 100-249, less than 100).||||0.30
72373162|NCT02522624|144256913|SUPERIORITY_OR_OTHER|||||||0.82|||||||Regression, Linear|||Controlling for Numeracy.||||0.82
72373163|NCT02522624|144256914|SUPERIORITY_OR_OTHER||||||<|0.001||||||A priori sample size estimates yielded an estimate of 183 per group needed to detect an effect size of 0.34 with 90% power at a 0.05 level of significance and 137 per group with 80% power.|Regression, Linear|||||||<.001
72373164|NCT02522624|144256914|SUPERIORITY_OR_OTHER|||||||0.82|||||||Regression, Linear|||Examined the relation between group and categorical outcomes, controlling for % Federal Poverty Level (400 or greater, 250-399, 100-249, less than 100).||||0.82
72373165|NCT02522624|144256914|SUPERIORITY_OR_OTHER|||||||0.15|||||||Regression, Linear|||Controlling for Numeracy.||||0.15
72373166|NCT02522624|144256915|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.48||||0.1|TWO_SIDED|95.0|0.92|2.36||A priori sample size estimates yielded an estimate of 183 per group needed to detect an effect size of 0.34 with 90% power at a 0.05 level of significance and 137 per group with 80% power.|Regression, Logistic|||||2.36|0.92|0.10
72373167|NCT02522624|144256915|SUPERIORITY_OR_OTHER|||||||0.26|||||||Regression, Logistic|||Examined the relation between group and categorical outcomes, controlling for % Federal Poverty Level (400 or greater, 250-399, 100-249, less than 100).||||0.26
72373168|NCT02522624|144256915|SUPERIORITY_OR_OTHER|||||||0.58|||||||Regression, Linear|||Controlling for Numeracy.||||0.58
72373169|NCT02522624|144256916|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.52|||<|0.001|TWO_SIDED|95.0|1.58|4.01||A priori sample size estimates yielded an estimate of 183 per group needed to detect an effect size of 0.34 with 90% power at a 0.05 level of significance and 137 per group with 80% power.|Regression, Logistic|||||4.01|1.58|<.001
72373170|NCT02522624|144256916|SUPERIORITY_OR_OTHER|||||||0.39||||||A priori sample size estimates yielded an estimate of 183 per group needed to detect an effect size of 0.34 with 90% power at a 0.05 level of significance and 137 per group with 80% power.|Regression, Logistic|||Examined the relation between group and categorical outcomes, controlling for % Federal Poverty Level (400 or greater, 250-399, 100-249, less than 100).||||0.39
72373171|NCT02522624|144256916|SUPERIORITY_OR_OTHER|||||||0.57|||||||Regression, Linear|||Controlling for Numeracy.||||0.57
72373172|NCT02522624|144256917|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|10.32|||<|0.001|TWO_SIDED|95.0|5.94|17.95||A priori sample size estimates yielded an estimate of 183 per group needed to detect an effect size of 0.34 with 90% power at a 0.05 level of significance and 137 per group with 80% power.|Regression, Logistic|||||17.95|5.94|<.001
72373173|NCT02522624|144256917|SUPERIORITY_OR_OTHER|||||||0.001||||||A priori sample size estimates yielded an estimate of 183 per group needed to detect an effect size of 0.34 with 90% power at a 0.05 level of significance and 137 per group with 80% power.|Regression, Logistic|||Examined the relation between group and categorical outcomes, controlling for % Federal Poverty Level (400 or greater, 250-399, 100-249, less than 100).||||0.001
72373174|NCT02522624|144256917|SUPERIORITY_OR_OTHER|||||||0.46|||||||Regression, Linear|||Controlling for numeracy.||||0.46
72373175|NCT00109590|144256934|SUPERIORITY_OR_OTHER_LEGACY|||||||0.009||95.0||||The p-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was two-sided P\<0.05.|wilcoxon Signed Rank Test|||The null hypothesis was that there was no difference in within-subject Cpredose LPV/r plasma drug concentrations within 72 hours after delivery versus at 30 days postpartum.||||0.009
72373176|NCT00109590|144256934|SUPERIORITY_OR_OTHER_LEGACY|||||||0.048||95.0||||The p-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was two-sided P\<0.05.|Wilcoxon Signed Rank Test|||The null hypothesis was that there was no difference in within-subject C4hour LPV/r plasma drug concentrations within 72 hours after delivery versus at 30 days postpartum||||0.048
72432909|NCT01124162|144378499|NON_INFERIORITY_OR_EQUIVALENCE|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level.|Ratio of the T/R geometric mean x 100|101.7|||||TWO_SIDED|90.0|98.57|104.93|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||104.93|98.57|
72373177|NCT00745849|144256944|SUPERIORITY|||||||0.45|||||||t-test, 2 sided|||||||0.45
72373178|NCT01129583|144256948|SUPERIORITY_OR_OTHER|||||||0.06||95.0|||||t-test, 2 sided|||||||0.06
72373179|NCT01129583|144256949|SUPERIORITY_OR_OTHER|||||||0.01||95.0|||||t-test, 2 sided|||||||0.01
72373180|NCT01129583|144256950|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||t-test, 2 sided|||||||0.02
72373181|NCT04672954|144256951|OTHER||Ratio|1.29||||0.3941|TWO_SIDED|90.0|0.78|2.13|||ANCOVA||Ratio = BI / Placebo. Geometric standard error = 1.34|The difference between the expected means for ln(T) - ln(R) was estimated by the difference in the corresponding least square means (point estimate) and two-sided 90% confidence intervals based on the t-distribution were computed. These quantities were back-transformed to the original scale to give the point estimator and interval estimates.||2.13|0.78|0.3941
72373182|NCT04672954|144256951|OTHER||Ratio|1.66||||0.1089|TWO_SIDED|90.0|0.99|2.79|||ANCOVA||Ratio = BI / Placebo. Geometric standard error = 1.35|The difference between the expected means for ln(T) - ln(R) was estimated by the difference in the corresponding least square means (point estimate) and two-sided 90% confidence intervals based on the t-distribution were computed. These quantities were back-transformed to the original scale to give the point estimator and interval estimates.||2.79|0.99|0.1089
72373183|NCT04672954|144256951|OTHER||Ratio|1.14||||0.6308|TWO_SIDED|90.0|0.71|1.85|||ANCOVA||Ratio = BI / Placebo. Geometric standard error = 1.32|The difference between the expected means for ln(T) - ln(R) was estimated by the difference in the corresponding least square means (point estimate) and two-sided 90% confidence intervals based on the t-distribution were computed. These quantities were back-transformed to the original scale to give the point estimator and interval estimates.||1.85|0.71|0.6308
72373184|NCT04672954|144256951|OTHER||Ratio|1.75||||0.069|TWO_SIDED|90.0|1.06|2.89|||ANCOVA||Ratio = BI / Placebo. Geometric standard error = 1.33|The difference between the expected means for ln(T) - ln(R) was estimated by the difference in the corresponding least square means (point estimate) and two-sided 90% confidence intervals based on the t-distribution were computed. These quantities were back-transformed to the original scale to give the point estimator and interval estimates.||2.89|1.06|0.0690
72373185|NCT00353470|144256958|SUPERIORITY||shared parameters model|-0.56|STANDARD_ERROR_OF_MEAN|0.29|>|0.16|TWO_SIDED||||||Chi-squared|||Power: to detect a between-group effect size of 0.45, for statistical power of 0.80, 56 patients for PFPP or CBT vs. 28 for ART were required. Response rates at termination were calculated by chi-square in the full ITT sample using LOCF.||||>0.16
72373186|NCT00353470|144256958|SUPERIORITY||||||<|0.05|||||||Mixed Models Analysis|||||||<.05
72373187|NCT02617485|144256972|EQUIVALENCE|Equivalence met if the 90% CI of the Geo LS Means ratio is contained with the pre-specified equivalence margin of 70% - 143%.|Ratio of Geo LS-means|1.0406|||||TWO_SIDED|90.0|0.9565|1.1321||||||Estimated Geo LS-means ratio.||1.1321|0.9565|
72373188|NCT02617485|144256973|EQUIVALENCE|Equivalence met if the 90% CI of the Geo LS Means ratio is contained with the pre-specified equivalence margin of 70% - 143%.|Ratio of Geo LS-means|1.0611|||||TWO_SIDED|90.0|0.9822|1.1464||||||Estimated Geo LS-means ratio.||1.1464|0.9822|
72373189|NCT01589653|144257153|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was to be considered confirmed if the upper bound of the two-sided 95% CI was below or equal to 0.4% or equivalently when the p-value for the one-sided test of H0: D \> 0.4% against HA: D ≤ 0.4%, was less than or equal to 2.5%, where D is the mean treatment difference (subject-driven titration minus investigator-driven titration).|Treatment difference|-0.23|||<|0.001|TWO_SIDED|95.0|-0.54|0.08|||Regression, Linear|Analyses were adjusted for treatment, strata, country and baseline HbA1c||The null-hypothesis was tested against the alternative hypothesis of non-inferiority as given by: H0: D \> 0.4% against HA: D ≤ 0.4% where D is the mean treatment difference for change in HbA1c (subject-driven titration minus investigator-driven titration).||0.08|-0.54|<0.001
72373190|NCT04250077|144257192|SUPERIORITY||proportion|0.36923076|STANDARD_ERROR_OF_MEAN|0.16518156||0.02578184|TWO_SIDED|95.0|-0.0021812|0.64531855|||Agresti Caffo proportion comparison|||||0.64531855|-0.0021812|0.02578184
72373191|NCT04250077|144257193|SUPERIORITY||Mean Difference (Net)|20.0454545|STANDARD_ERROR_OF_MEAN|7.62386242||0.00787297|TWO_SIDED|95.0|4.18213496|35.9087741|||t-test, 1 sided|||||35.9087741|4.18213496|0.00787297
72373192|NCT04250077|144257194|SUPERIORITY||Mean Difference (Net)|-39.183333|STANDARD_ERROR_OF_MEAN|15.8274398||0.01387108|TWO_SIDED|95.0|-73.356073|-5.0105927|||t-test, 1 sided|||||-5.0105927|-73.356073|0.01387108
72373193|NCT04250077|144257195|SUPERIORITY||Mean Difference (Net)|8.43728901|STANDARD_ERROR_OF_MEAN|3.28323704||0.00908118|TWO_SIDED|95.0|1.59437702|15.280201|||t-test, 1 sided|||||15.2802010|1.59437702|0.00908118
72373194|NCT04250077|144257196|SUPERIORITY||Mean Difference (Net)|1.47698833|STANDARD_ERROR_OF_MEAN|3.68529034||0.34633293|TWO_SIDED|95.0|-6.1910435|9.14502026|||t-test, 1 sided|||||9.14502026|-6.1910435|0.34633293
72373195|NCT04250077|144257197|SUPERIORITY||Mean Difference (Final Values)|-0.4285714|STANDARD_ERROR_OF_MEAN|2.07315199||0.57872623|TWO_SIDED|95.0|-5.4078121|4.55066924|||t-test, 1 sided|||||4.55066924|-5.4078121|0.57872623
72373196|NCT04250077|144257198|SUPERIORITY||Median Difference (Net)|1.29230769|STANDARD_ERROR_OF_MEAN|0.81588207||0.06283641|TWO_SIDED|95.0|-0.3873203|2.97193574|||t-test, 1 sided|||||2.97193574|-0.3873203|0.06283641
72373197|NCT04250077|144257199|SUPERIORITY||proportion|0.11794871|STANDARD_ERROR_OF_MEAN|0.16796576||0.26422281|TWO_SIDED|95.0|-0.2233244|0.43508919|||Agresti Caffo proportion comparison|||||0.43508919|-0.2233244|0.26422281
72373198|NCT00505076|144257226|SUPERIORITY_OR_OTHER|||||||0.21|||||||ANCOVA|||An analysis of covariance (ANCOVA), adjusting for baseline scores, was used to compare treatment groups on cognitive and functional measures. The predefined primary cognition outcome measure was the MCCB (MATRICS (Measurement and Treatment Research to Improve Cognition in Schizophrenia Research) Consensus Cognitive Battery) composite T-score, tested at overall two-sided alpha=0.05.||||0.21
72373199|NCT00505076|144257227|SUPERIORITY_OR_OTHER|||||||0.47|TWO_SIDED||||||ANCOVA|||The sample size was determined using the analysis of covariance power formula, n=2\[za+zβ\]2s2 (1-R2)/d2, with za=2.24, zβ=0.842 (corresponding to power=0.80), R=the correlation between baseline and end of study measures of the outcome, d the difference between groups, and s the standard deviation of the outcome. Actual recruitment was only about 20 participants per group, but the observed R≅0.9, suggesting power to detect an effect size of 0.49.||||0.47
72373200|NCT00505076|144257228|SUPERIORITY_OR_OTHER|||||||0.84|TWO_SIDED||||||ANCOVA|||The sample size was determined using the analysis of covariance power formula, n=2\[za+zβ\]2s2 (1-R2)/d2, with za=2.24, zβ=0.842 (corresponding to power=0.80), R=the correlation between baseline and end of study measures of the outcome, d the difference between groups, and s the standard deviation of the outcome. Actual recruitment was only about 20 participants per group, but the observed R≅0.9, suggesting power to detect an effect size of 0.49.||||0.84
72373201|NCT00653432|144257251|SUPERIORITY|||||||0.145|||||||Ordinal GEE Model|||||||0.1450
72373202|NCT00653432|144257252|SUPERIORITY|||||||0.5824|||||||Ordinal GEE Model|||||||0.5824
72373203|NCT00653432|144257253|SUPERIORITY|||||||0.9136|||||||Ordinal GEE Model|||||||0.9136
72373204|NCT00653432|144257254|SUPERIORITY|||||||0.1699|||||||Ordinal GEE Model|||||||0.1699
72373205|NCT00653432|144257255|SUPERIORITY|||||||0.3238|||||||Ordinal GEE Model|||||||0.3238
72373206|NCT00653432|144257256|SUPERIORITY|||||||0.0427|||||||Ordinal GEE Model|||||||0.0427
72493660|NCT03048422|144516483|SUPERIORITY||Mean Difference (Final Values)|0.058||||0.011|TWO_SIDED|95.0|0.013|0.103|||Generalized Estimating Equation|||Null hypothesis of no difference between arms (DTG+FTC/TAF - DTG+FTC/TDF).||0.103|0.013|0.011
72373207|NCT00653432|144257257|SUPERIORITY|||||||0.8206|||||||Ordinal GEE Model|||||||0.8206
72373208|NCT00653432|144257258|SUPERIORITY|||||||0.9818|||||||Ordinal GEE Model|||||||0.9818
72373209|NCT00653432|144257259|SUPERIORITY|||||||0.0542|||||||Ordinal GEE Model|||||||0.0542
72373210|NCT00653432|144257260|SUPERIORITY|||||||0.323|||||||Ordinal GEE Model|||||||0.3230
72373211|NCT01743001|144257261|SUPERIORITY||least-square (LS) mean difference|-4.7||||0.612|TWO_SIDED|95.0|-22.8|13.5||To control for multiplicity across the primary and secondary endpoints, all secondary endpoints were analyzed hierarchically according to order and significance as pre-specified in the protocol eliminating further adjustment for multiple comparisons.|ANCOVA|ANCOVA model included treatment group, presence of DS (yes/no), and WHO FC (II vs III/IV) as categorical factors, and baseline 6MWD value as covariate||The null hypothesis was that there was no difference between macitentan and placebo for the mean change from baseline to Week 16 in 6MWD. Null hypothesis was tested by an analysis of covariance (ANCOVA).||13.5|-22.8|0.6120
72373212|NCT01743001|144257262|SUPERIORITY||Odds Ratio (OR)|0.53||||0.145|TWO_SIDED|95.0|0.23|1.24||The secondary efficacy endpoints were analyzed hierarchically as this approach eliminated the requirement for further adjustment for multiple comparisons.|Regression, Logistic|Logistic regression model adjusted for randomized treatment group and location of cardiac defect (pre-tricupsid / post-tricupsid ) as factors.||For this secondary endpoint of WHO functional class, the improvement from baseline to Week 16 in WHO functional class was evaluated. The null hypothesis is the odds of improvement are the same in the placebo and the macitentan group.||1.24|0.23|0.1450
72373213|NCT01743001|144257263|SUPERIORITY||least-square (LS) mean difference|0.08||||0.6818||95.0|-0.29|0.44||The secondary efficacy endpoints were analyzed hierarchically as this approach eliminated the requirement for further adjustment for multiple comparisons.|ANCOVA|Adjusted for randomized treatment group, location of cardiac defect(pre-tricupsid/post-tricupsid) as factors, baseline Borg dyspnea index as covariate||The null hypothesis was that the mean change from baseline to Week 16 in the Borg dyspnea index is the same in the macitentan and in the placebo group.||0.44|-0.29|0.6818
72373214|NCT01743001|144257264|SUPERIORITY||least-square (LS) mean difference|-1.0||||0.6431|TWO_SIDED|95.0|-5.0|3.1|||ANCOVA|Adjusted for randomized treatment group, location of cardiac defect (pre-tricupsid/post-tricupsid) as factors and baseline scores as covariates.||The null hypothesis is that the mean change from baseline to Week 16 is the same in the macitentan and the placebo group for the SF-36 domain score of Physical Functioning.||3.1|-5.0|0.6431
72373215|NCT01743001|144257264|SUPERIORITY||least-square (LS) mean difference|-1.4||||0.5988|TWO_SIDED|95.0|-6.7|3.9|||ANCOVA|Adjusted for randomized treatment group, location of cardiac defect (pre-tricupsid/post-tricupsid) as factors and baseline scores as covariates.||The null hypothesis is that the mean change from baseline to Week 16 is the same in the macitentan and the placebo group for the SF-36 domain score of Role-Physical.||3.9|-6.7|0.5988
72373216|NCT01743001|144257264|SUPERIORITY||least-square (LS) mean difference|0.1||||0.9642|TWO_SIDED|95.0|-5.9|6.2|||ANCOVA|Adjusted for randomized treatment group, location of cardiac defect (pre-tricupsid/post-tricupsid) as factors and baseline scores as covariates.||The null hypothesis is that the mean change from baseline to Week 16 is the same in the macitentan and the placebo group for the SF-36 domain score of Pain Index.||6.2|-5.9|0.9642
72373217|NCT01743001|144257264|SUPERIORITY||least-square (LS) mean difference|3.1||||0.1542|TWO_SIDED|95.0|-1.2|7.3|||ANCOVA|Adjusted for randomized treatment group, location of cardiac defect (pre-tricupsid/post-tricupsid) as factors and baseline scores as covariates.||The null hypothesis is that the mean change from baseline to Week 16 is the same in the macitentan and the placebo group for the SF-36 domain score of General Health Perceptions.||7.3|-1.2|0.1542
72373218|NCT01743001|144257264|SUPERIORITY||least-square (LS) mean difference|1.1||||0.602|TWO_SIDED|95.0|-3.1|5.3|||ANCOVA|Adjusted for randomized treatment group, location of cardiac defect (pre-tricupsid/post-tricupsid) as factors and baseline scores as covariates.||The null hypothesis is that the mean change from baseline to Week 16 is the same in the macitentan and the placebo group for the SF-36 domain score of Vitality.||5.3|-3.1|0.6020
72373219|NCT01743001|144257264|SUPERIORITY||least-square (LS) mean difference|-1.4||||0.634|TWO_SIDED|95.0|-7.2|4.4|||ANCOVA|Adjusted for randomized treatment group, location of cardiac defect (pre-tricupsid/post-tricupsid) as factors and baseline scores as covariates.||The null hypothesis is that the mean change from baseline to Week 16 is the same in the macitentan and the placebo group for the SF-36 domain score of Social Functioning.||4.4|-7.2|0.6340
72373220|NCT01743001|144257264|SUPERIORITY||least-square (LS) mean difference|-2.8||||0.3384|TWO_SIDED|95.0|-8.7|3.0|||ANCOVA|Adjusted for randomized treatment group, location of cardiac defect (pre-tricupsid/post-tricupsid) as factors and baseline scores as covariates.||The null hypothesis is that the mean change from baseline to Week 16 is the same in the macitentan and the placebo group for the SF-36 domain score of Role-Emotional.||3.0|-8.7|0.3384
72373221|NCT01743001|144257264|SUPERIORITY||least-square (LS) mean difference|-2.3||||0.2704|TWO_SIDED|95.0|-6.4|1.8|||ANCOVA|Adjusted for randomized treatment group, location of cardiac defect (pre-tricupsid/post-tricupsid) as factors and baseline scores as covariates.||The null hypothesis is that the mean change from baseline to Week 16 is the same in the macitentan and the placebo group for the SF-36 domain score of Mental Health Index.||1.8|-6.4|0.2704
72373222|NCT01743001|144257264|SUPERIORITY||least-square (LS) mean difference|-0.4||||0.6431|TWO_SIDED|95.0|-2.1|1.3|||ANCOVA|Adjusted for randomized treatment group, location of cardiac defect (pre-tricupsid/post-tricupsid) as factors and baseline scores as covariates.||The null hypothesis is that the mean change from baseline to Week 16 is the same in the macitentan and the placebo group for the SF-36 domain score of Physical Functioning (norm-based).||1.3|-2.1|0.6431
72373223|NCT01743001|144257264|SUPERIORITY||least-square (LS) mean difference|-0.6||||0.5988|TWO_SIDED|95.0|-2.6|1.5|||ANCOVA|Adjusted for randomized treatment group, location of cardiac defect (pre-tricupsid/post-tricupsid) as factors and baseline scores as covariates.||The null hypothesis is that the mean change from baseline to Week 16 is the same in the macitentan and the placebo group for the SF-36 domain score of Role-Physical (norm-based).||1.5|-2.6|0.5988
72373224|NCT01743001|144257264|SUPERIORITY||least-square (LS) mean difference|0.1||||0.9642|TWO_SIDED|95.0|-2.5|2.6|||ANCOVA|Adjusted for randomized treatment group, location of cardiac defect (pre-tricupsid/post-tricupsid) as factors and baseline scores as covariates.||The null hypothesis is that the mean change from baseline to Week 16 is the same in the macitentan and the placebo group for the SF-36 domain score of Pain Index (norm-based).||2.6|-2.5|0.9642
72493661|NCT03048422|144516483|SUPERIORITY||Mean Difference (Final Values)|0.028||||0.19|TWO_SIDED|95.0|-0.014|0.07|||Generalized Estimating Equation|||Null hypothesis of no difference between arms (DTG+FTC/TDF - EFV/FTC/TDF).||0.070|-0.014|0.19
72555352|NCT01929863|144642237|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-29.35|||||TWO_SIDED|95.0|-50.84|-7.86|||||The point estimate was calculated as least square mean difference (net values) of Treatment A-GSK2330672 + Metformin and Treatment B-Placebo + Metformin for Maximum (0-24 h) Value.|Treatment A-GSK2330672 + Metformin versus Treatment B-Placebo + Metformin for Maximum (0-24 h) Value.||-7.86|-50.84|
72373225|NCT01743001|144257264|SUPERIORITY||least-square (LS) mean difference|1.5||||0.1542|TWO_SIDED|95.0|-0.6|3.5|||ANCOVA|Adjusted for randomized treatment group, location of cardiac defect (pre-tricupsid/post-tricupsid) as factors and baseline scores as covariates.||The null hypothesis is that the mean change from baseline to Week 16 is the same in the macitentan and the placebo group for the SF-36 domain score of General Health Perceptions (norm-based).||3.5|-0.6|0.1542
72373226|NCT01743001|144257264|SUPERIORITY||least-square (LS) mean difference|0.6||||0.602|TWO_SIDED|95.0|-1.5|2.6|||ANCOVA|Adjusted for randomized treatment group, location of cardiac defect (pre-tricupsid/post-tricupsid) as factors and baseline scores as covariates.||The null hypothesis is that the mean change from baseline to Week 16 is the same in the macitentan and the placebo group for the SF-36 domain score of Vitality (norm-based).||2.6|-1.5|0.6020
72373227|NCT01743001|144257264|SUPERIORITY||least-square (LS) mean difference|-0.6||||0.634|TWO_SIDED|95.0|-3.1|1.9|||ANCOVA|Adjusted for randomized treatment group, location of cardiac defect (pre-tricupsid/post-tricupsid) as factors and baseline scores as covariates.||The null hypothesis is that the mean change from baseline to Week 16 is the same in the macitentan and the placebo group for the SF-36 domain score of Social Functioning (norm-based).||1.9|-3.1|0.6340
72373228|NCT01743001|144257264|SUPERIORITY||least-square (LS) mean difference|-1.3||||0.3384|TWO_SIDED|95.0|-4.1|1.4|||ANCOVA|Adjusted for randomized treatment group, location of cardiac defect (pre-tricupsid/post-tricupsid) as factors and baseline scores as covariates.||The null hypothesis is that the mean change from baseline to Week 16 is the same in the macitentan and the placebo group for the SF-36 domain score of Role-Emotional (norm-based).||1.4|-4.1|0.3384
72373229|NCT01743001|144257264|SUPERIORITY||least-square (LS) mean difference|-1.3||||0.2704|TWO_SIDED|95.0|-3.6|1.0|||ANCOVA|Adjusted for randomized treatment group, location of cardiac defect (pre-tricupsid/post-tricupsid) as factors and baseline scores as covariates.||The null hypothesis is that the mean change from baseline to Week 16 is the same in the macitentan and the placebo group for the SF-36 domain score of Mental Health Index.||1.0|-3.6|0.2704
72373230|NCT01743001|144257264|SUPERIORITY||least-square (LS) mean difference|0.7||||0.4332|TWO_SIDED|95.0|-1.0|2.3|||ANCOVA|Adjusted for randomized treatment group, location of cardiac defect (pre-tricupsid/post-tricupsid) as factors and baseline scores as covariates.||The null hypothesis is that the mean change from baseline to Week 16 is the same in the macitentan and the placebo group for the Physical Component Summary Score.||2.3|-1.0|0.4332
72373231|NCT01743001|144257264|SUPERIORITY||least-square (LS) mean difference|-1.1||||0.3416|TWO_SIDED|95.0|-3.4|1.2|||ANCOVA|Adjusted for randomized treatment group, location of cardiac defect (pre-tricupsid/post-tricupsid) as factors and baseline scores as covariates.||The null hypothesis is that the mean change from baseline to Week 16 is the same in the macitentan and the placebo group for the Mental Component Summary Score.||1.2|-3.4|0.3416
72373232|NCT01565343|144257267|SUPERIORITY_OR_OTHER||ICC|0.9893||||||95.0|||||ICC|||Intra-class Correlation Coefficient (ICC) of AD subjects 50-70 min test vs. retest values||||
72493662|NCT03048422|144516483|SUPERIORITY||Mean Difference (Final Values)|0.086|||<|0.001|TWO_SIDED|95.0|0.04|0.133|||Generalized Estimating Equation|||Null hypothesis of no difference between arms (DTG+FTC/TAF - EFV/FTC/TDF).||0.133|0.040|< 0.001
72373233|NCT01565343|144257267|SUPERIORITY_OR_OTHER||ICC|0.9574||||||95.0|||||ICC|||Intra-class Correlation Coefficient of Control subjects 50-70 min test vs. retest values||||
72373234|NCT01565343|144257267|SUPERIORITY_OR_OTHER||Mean % difference|2.35|STANDARD_DEVIATION|1.413||||95.0||||||||Intra-subject variability (% difference) of AD subjects 50-70 min test vs. retest values||||
72373235|NCT01565343|144257267|SUPERIORITY_OR_OTHER||Mean % difference|1.49|STANDARD_DEVIATION|0.839||||95.0||||||||Intra-subject variability (% difference) of control subjects 50-70 min test vs. retest values||||
72373236|NCT00835211|144257302|NON_INFERIORITY_OR_EQUIVALENCE|Analyses of Variance (ANOVA) were performed on the log-transformed AUC0-t, AUCinf and Cmax. These analyses were performed using the SAS® procedure.|Test/Ref Ratio of LS Means x 100|97.5||||||90.0|87.8|108.3|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||108.3|87.8|
72373237|NCT00835211|144257303|NON_INFERIORITY_OR_EQUIVALENCE|Analyses of Variance (ANOVA) were performed on the log-transformed AUC0-t, AUCinf and Cmax. These analyses were performed using the SAS® procedure.|Test/Ref Ratio of LS Means x 100|95.6||||||90.0|86.9|105.2|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||105.2|86.9|
72373238|NCT00835211|144257304|NON_INFERIORITY_OR_EQUIVALENCE|Analyses of Variance (ANOVA) were performed on the log-transformed AUC0-t, AUCinf and Cmax. These analyses were performed using the SAS® procedure.|Test/Ref Ratio of LS Means x 100|96.5||||||90.0|87.7|106.1|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||106.1|87.7|
72373239|NCT02343549|144257305|SUPERIORITY||12-Month Survival Rate|0.333||||0.537|TWO_SIDED|95.0|0.075|0.701||This p-value is only based on partial enrollment of Stage 1. As enrollment was halted early, this p-value is descriptive in nature and cannot determine the success/failure of the trial.|Fisher Exact||Confidence interval estimated using the Clopper Pearson method.|Assuming the true 12-month survival rate is 0.30 under the null hypothesis, then this design will provide 90% power to detect a difference of 0.20 under the alternative hypothesis, assuming a one-sided alpha = 0.10 significance level. A Simon optimal 2-stage design with Stage 1 n=22 and a total of n=46 subjects was determined with the following rejection regions: For n = 22, the rejection region in number of subjects alive at 12 months is 0 - 7, and for n = 46 it is 8 - 17.||0.701|0.075|0.537
72373240|NCT02343549|144257306|OTHER|Estimation Only|Median|9.9|||||TWO_SIDED|95.0|4.8|12.8|||||The Kaplan Meier method was used to estimate median OS(in months). The Greenwood method was used to estimate confidence limits of median overall survival.|||12.8|4.8|
72373241|NCT02343549|144257307|OTHER|Estimation Only|Median|7.9|||||TWO_SIDED|95.0|4.8|10.4|||||The Kaplan Meier method was used to estimate median PFS (in months). The Greenwood method was used to estimate confidence limits of median progression free survival.|||10.4|4.8|
72373242|NCT02343549|144257308|OTHER|Estimation only|Response Rate|0.333|||||TWO_SIDED|95.0|0.075|0.701|||||Confidence interval estimated using the Clopper Pearson method.|||0.701|0.075|
72373243|NCT02343549|144257309|OTHER|Estimation only|Disease Control Rate|1.0|||||TWO_SIDED|95.0|0.664|1.0||||||||1.000|0.664|
72373244|NCT02343549|144257310|OTHER|Estimation only.|Median|8.1|||||TWO_SIDED|95.0|3.7|8.6|||||The Kaplan Meier method was used to estimate median duration of response (in months). The Greenwood method was used to estimate confidence limits of median duration of response.|||8.6|3.7|
72373245|NCT02343549|144257311|OTHER|Estimation Only|Median|7.9|||||TWO_SIDED|95.0|4.8|10.4|||||The Kaplan Meier method was used to estimate median duration of disease control (in months). The Greenwood method was used to estimate confidence limits of median duration of disease control.|||10.4|4.8|
72373246|NCT01864005|144257328|SUPERIORITY_OR_OTHER|||||||0.0021||||||not adjusted for multiple comparisons. statistical significance level: 0.05|Wilcoxon (Mann-Whitney)|||||||0.0021
72373247|NCT01864005|144257328|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|38.421||||0.0003|TWO_SIDED|95.0|18.559|58.283|||ANOVA|||||58.283|18.559|0.0003
72373248|NCT01864005|144257329|SUPERIORITY_OR_OTHER|||||||0.0828|||||||Wilcoxon (Mann-Whitney)|||||||0.0828
72373249|NCT01864005|144257330|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
72373250|NCT01864005|144257331|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
72373251|NCT01864005|144257332|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
72373252|NCT00763698|144257333|SUPERIORITY_OR_OTHER||Objective Performance Criteria|80.0|||||ONE_SIDED|95.0|5.0||||Kaplan-Meier Survival Analysis|||The objective performance criteria established for freedom from left ventricular lead related complications at 3 months was greater than 80%. At least 80% of the patients were required to be free from left venticular lead related complications at 3 months.|||5|
72373253|NCT00763698|144257334|SUPERIORITY_OR_OTHER||Objective Performance Criteria|80.0|||||ONE_SIDED|97.5|2.5||||Wilson score interval method||||||2.5|
72373254|NCT03241368|144257336|OTHER|Comparative - This purpose of this study is to evaluate performance of the PillCam Crohn's capsule \[referred to as capsule endoscopy (CE)\] as compared to IC with MRE.||||||0.125|||||||McNemar|Exact McNemar's test||This was a 1-arm, non-powered study. Sensitivity, Specificity, Positive Predictive Value (PPV) and Negative Predictive Value (NPV) was estimated for each treatment group, along with the 95% confidence interval. The difference between treatment groups in Sensitivity and Specificity was compared.||||0.125
72373255|NCT04343235|144257362|SUPERIORITY|||||||0.21|||||||Fisher Exact|||||||0.21
72373256|NCT04343235|144257363|SUPERIORITY|||||||0.7||||||Main effect for Randomization group|ANOVA|||||||0.70
72373257|NCT04343235|144257364|SUPERIORITY|||||||0.77|||||||ANOVA|Main effect for randomization group||||||0.77
72373258|NCT04343235|144257365|SUPERIORITY|||||||0.54|||||||ANOVA|Main effect for randomization group||||||0.54
72373259|NCT04343235|144257366|SUPERIORITY||Mean Difference (Final Values)|0.79|STANDARD_ERROR_OF_MEAN|1.0||0.47|TWO_SIDED|95.0|-1.5|3.1|||t-test, 2 sided|||||3.1|-1.5|0.47
72373260|NCT04343235|144257367|SUPERIORITY|||||||0.57|||||||Fisher Exact|||||||0.57
72373261|NCT04343235|144257368|SUPERIORITY||||||>|0.99|||||||Fisher Exact|||||||>0.99
72373262|NCT01252732|144257405|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The non-inferiority hypothesis test is a one sided hypothesis test performed at the 2.5% level of significance. If the lower limit of the two-sided 95% CI for the difference in response rates in the mITT population is greater than -10% the NI of oritavancin to vancomycin is concluded.|Difference in Proportions|-2.7|||||TWO_SIDED|95.0|-7.5|2.0||||||||2.0|-7.5|
72373263|NCT01252732|144257406|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The non-inferiority hypothesis test is a one sided hypothesis test performed at the 2.5% level of significance. If the lower limit of the two-sided 95% CI for the difference in response rates in the mITT population is greater than -10% the NI of oritavancin to vancomycin is concluded.|Difference in Proportions|2.2|||||TWO_SIDED|95.0|-2.6|7.0||||||||7.0|-2.6|
72373264|NCT01252732|144257407|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The non-inferiority hypothesis test is a one sided hypothesis test performed at the 2.5% level of significance. If the lower limit of the two-sided 95% CI for the difference in response rates in the mITT population is greater than -10% the NI of oritavancin to vancomycin is concluded.|Difference in Proportions|0.6|||||TWO_SIDED|95.0|-3.7|5.0||||||||5.0|-3.7|
72373265|NCT04236141|144257409|SUPERIORITY||Difference in Response Rates|10.71|||||TWO_SIDED|95.0|-19.0|40.43||||||||40.43|-19.00|
72373266|NCT04236141|144257410|SUPERIORITY||Difference in Response Rates|7.14|||||TWO_SIDED|95.0|-22.03|36.31||||||||36.31|-22.03|
72373267|NCT04236141|144257411|SUPERIORITY||Difference in Response Rates|14.29|||||TWO_SIDED|95.0|-15.89|44.46||||||||44.46|-15.89|
72373268|NCT04236141|144257412|SUPERIORITY||Difference in Response Rates|21.43|||||TWO_SIDED|95.0|-9.44|52.3||||||||52.30|-9.44|
72373269|NCT04236141|144257413|SUPERIORITY||Difference in Response Rates|17.86|||||TWO_SIDED|95.0|-1.69|37.4||||||||37.40|-1.69|
72373270|NCT04236141|144257414|SUPERIORITY||Difference in Response Rates|17.86|||||TWO_SIDED|95.0|-1.69|37.4||||||||37.40|-1.69|
72373271|NCT04236141|144257415|SUPERIORITY||Difference in Response Rates|17.86|||||TWO_SIDED|95.0|-12.7|48.42||||||||48.42|-12.70|
72373272|NCT04236141|144257416|SUPERIORITY||Difference in Response Rates|14.29|||||TWO_SIDED|95.0|-15.89|44.46||||||||44.46|-15.89|
72373273|NCT04236141|144257417|SUPERIORITY||Difference in Response Rates|25.0|||||TWO_SIDED|95.0|-10.38|60.38||||||||60.38|-10.38|
72373274|NCT04236141|144257418|SUPERIORITY||Difference in Response Rates|3.57|||||TWO_SIDED|95.0|-33.84|40.98||||||||40.98|-33.84|
72373275|NCT01954927|144257437|SUPERIORITY|||||||0.227||||||1-sided p-value|z-test Proportion|z-test of proportions without continuity correction||||||0.227
72373276|NCT01954927|144257438|SUPERIORITY|||||||0.897|||||||Wilcoxon (Mann-Whitney)|||||||0.897
72373277|NCT01954927|144257439|SUPERIORITY|||||||0.181|||||||Chi-squared|||||||0.181
72373278|NCT01954927|144257440|SUPERIORITY|||||||0.73|||||||Wilcoxon (Mann-Whitney)|||||||0.730
72373279|NCT01954927|144257441|SUPERIORITY|||||||0.713|||||||Chi-squared|||||||0.713
72373280|NCT01954927|144257442|SUPERIORITY|||||||0.739|||||||Wilcoxon (Mann-Whitney)|||||||0.739
72373281|NCT01954927|144257443|SUPERIORITY|||||||0.388|||||||Wilcoxon (Mann-Whitney)|||||||0.388
72373282|NCT00955305|144257454|SUPERIORITY_OR_OTHER|||||||0.33||||||one-sided p-value using stratified logrank test stratified on the randomization stratification factors|Log Rank|Stratified log rank test stratified on the randomization stratification factors||||||0.33
72373283|NCT00955305|144257455|SUPERIORITY_OR_OTHER|||||||0.95||||||two-sided p-value by stratified log rank test stratified on the randomization stratification factors|Log Rank|Stratified log rank test stratified on the randomization stratification factors||||||0.95
72373284|NCT00955305|144257456|SUPERIORITY_OR_OTHER|||||||0.15||||||two sided p-value by Fisher's exact test|Fisher Exact|||||||0.15
72373285|NCT00535288|144257503|SUPERIORITY_OR_OTHER||Difference between least squares means|-1.2|||<|0.01|TWO_SIDED|95.0|-2.2|-0.2||Confidence intervals and p-values were adjusted by (2-sided) Dunnett many-to-one comparison at 0.05 overall Type 1 error rate.|ANCOVA|Factors for treatment group and (pooled) center and a covariate for the baseline frequency||||-0.2|-2.2|<0.01
72373286|NCT00535288|144257503|SUPERIORITY_OR_OTHER||Difference between least squares means|-1.7|||<|0.01|TWO_SIDED|95.0|-2.7|-0.7||Confidence intervals and p-values were adjusted by (2-sided) Dunnett many-to-one comparison at 0.05 overall Type 1 error rate.|ANCOVA|Factors for treatment group and (pooled) center and a covariate for the baseline frequency||||-0.7|-2.7|<0.01
72373287|NCT00535288|144257503|SUPERIORITY_OR_OTHER||Difference between least squares means|-1.4|||<|0.01|TWO_SIDED|95.0|-2.4|-0.4||Confidence intervals and p-values were adjusted by (2-sided) Dunnett many-to-one comparison at 0.05 overall Type 1 error rate|ANCOVA|Factors for treatment group and (pooled) center and a covariate for the baseline frequency||||-0.4|-2.4|<0.01
72373288|NCT00535288|144257503|SUPERIORITY_OR_OTHER||Difference between least squares means|-1.9|||<|0.01|TWO_SIDED|95.0|-2.9|-0.9||Confidence intervals and p-values were adjusted by (2-sided) Dunnett many-to-one comparison at 0.05 overall Type 1 error rate|ANCOVA|Factors for treatment group and (pooled) center and a covariate for the baseline frequency||||-0.9|-2.9|<0.01
72373289|NCT00535288|144257504|SUPERIORITY_OR_OTHER||Difference between least squares means|-0.07|||<|0.01|TWO_SIDED|95.0|-0.12|-0.01||Confidence intervals and p-values were adjusted by (2-sided) Dunnett many-to-one comparison at 0.05 overall Type 1 error rate.|ANCOVA|Factors for treatment group and (pooled) center and a covariate for the baseline severity||||-0.01|-0.12|<0.01
72373290|NCT00535288|144257504|SUPERIORITY_OR_OTHER||Difference between least squares means|-0.06||||0.02|TWO_SIDED|95.0|-0.11|-0.01||Confidence intervals and p-values were adjusted by (2-sided) Dunnett many-to-one comparison at 0.05 overall Type 1 error rate.|ANCOVA|Factors for treatment group and (pooled) center and a covariate for the baseline severity||||-0.01|-0.11|0.02
72373291|NCT00535288|144257504|SUPERIORITY_OR_OTHER||Difference between least squares means|-0.07|||<|0.01|TWO_SIDED|95.0|-0.13|-0.02||Confidence intervals and p-values were adjusted by (2-sided) Dunnett many-to-one comparison at 0.05 overall Type 1 error rate.|ANCOVA|Factors for treatment group and (pooled) center and a covariate for the baseline severity||||-0.02|-0.13|<0.01
72373292|NCT00535288|144257504|SUPERIORITY_OR_OTHER||Difference between least squares means|-0.08|||<|0.01|TWO_SIDED|95.0|-0.14|-0.03||Confidence intervals and p-values were adjusted by (2-sided) Dunnett many-to-one comparison at 0.05 overall Type 1 error rate.|ANCOVA|Factors for treatment group and (pooled) center and a covariate for the baseline severity||||-0.03|-0.14|<0.01
72373293|NCT00535288|144257505|SUPERIORITY_OR_OTHER||Difference between least squares means|-1.0||||0.08|TWO_SIDED|95.0|-2.1|0.1||Confidence intervals and p-values were adjusted by (2-sided) Dunnett many-to-one comparison at 0.05 overall Type 1 error rate.|ANCOVA|Factors for treatment group and (pooled) center and a covariate for the baseline frequency||||0.1|-2.1|0.08
72373294|NCT00535288|144257505|SUPERIORITY_OR_OTHER||Difference between least squares means|-1.6|||<|0.01|TWO_SIDED|95.0|-2.7|-0.5||Confidence intervals and p-values were adjusted by (2-sided) Dunnett many-to-one comparison at 0.05 overall Type 1 error rate.|ANCOVA|Factors for treatment group and (pooled) center and a covariate for the baseline frequency||||-0.5|-2.7|<0.01
72373295|NCT00535288|144257505|SUPERIORITY_OR_OTHER||Difference between least squares means|-1.5|||<|0.01|TWO_SIDED|95.0|-2.7|-0.4||Confidence intervals and p-values were adjusted by (2-sided) Dunnett many-to-one comparison at 0.05 overall Type 1 error rate.|ANCOVA|Factors for treatment group and (pooled) center and a covariate for the baseline frequency||||-0.4|-2.7|<0.01
72373296|NCT00535288|144257505|SUPERIORITY_OR_OTHER||Difference between least squares means|-2.0|||<|0.01|TWO_SIDED|95.0|-3.1|-0.9||Confidence intervals and p-values were adjusted by (2-sided) Dunnett many-to-one comparison at 0.05 overall Type 1 error rate.|ANCOVA|Factors for treatment group and (pooled) center and a covariate for the baseline frequency||||-0.9|-3.1|<0.01
72373297|NCT00535288|144257508|SUPERIORITY_OR_OTHER||Difference between least squares means|-0.06||||0.07|TWO_SIDED|95.0|-0.12|0.0||Confidence intervals and p-values were adjusted by (2-sided) Dunnett many-to-one comparison at 0.05 overall Type 1 error rate.|ANCOVA|Factors for treatment group and (pooled) center and a covariate for the baseline severity||||0.00|-0.12|0.07
72373298|NCT00535288|144257508|SUPERIORITY_OR_OTHER||Difference between least squares means|-0.05||||0.24|TWO_SIDED|95.0|-0.11|0.02||Confidence intervals and p-values were adjusted by (2-sided) Dunnett many-to-one comparison at 0.05 overall Type 1 error rate.|ANCOVA|Factors for treatment group and (pooled) center and a covariate for the baseline severity||||0.02|-0.11|0.24
72555353|NCT01929863|144642237|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-26.14|||||TWO_SIDED|95.0|-45.8|-6.49|||||The point estimate was calculated as least square mean difference (net values) of Treatment A-GSK2330672 + Metformin and Treatment B-Placebo + Metformin for AUC (0-4 h) Weighted Mean.|Treatment A-GSK2330672 + Metformin versus Treatment B-Placebo + Metformin for AUC (0-4 h) Weighted Mean||-6.49|-45.80|
72373299|NCT00535288|144257508|SUPERIORITY_OR_OTHER||Difference between least squares means|-0.04||||0.29|TWO_SIDED|95.0|-0.11|0.02||Confidence intervals and p-values were adjusted by (2-sided) Dunnett many-to-one comparison at 0.05 overall Type 1 error rate.|ANCOVA|Factors for treatment group and (pooled) center and a covariate for the baseline severity||||0.02|-0.11|0.29
72373300|NCT00535288|144257508|SUPERIORITY_OR_OTHER||Difference between least squares means|-0.07||||0.02|TWO_SIDED|95.0|-0.14|-0.01||Confidence intervals and p-values were adjusted by (2-sided) Dunnett many-to-one comparison at 0.05 overall Type 1 error rate.|ANCOVA|Factors for treatment group and (pooled) center and a covariate for the baseline severity||||-0.01|-0.14|0.02
72373301|NCT02600871|144257517|SUPERIORITY|The significance of variation in proportions with treatment (Provodine®, Control) was assessed with Fisher's Exact tests and variation in the mean with treatment was assessed with T-tests.||||||0.71|||||||Fisher Exact|||||||0.71
72373302|NCT03745820|144257544|SUPERIORITY||Least Squares (LS) Mean Difference|-0.26|STANDARD_ERROR_OF_MEAN|1.328|=|0.8472|TWO_SIDED|95.0|-2.88|2.37|||MMRM|||Mixed Model Repeated Measures(MMRM)model was used to analyze change from baseline of outcome measure(OM)using fixed effects of treatment group,region,study visit,study visit-by-treatment interaction,baseline value of OM,baseline-by-visit interaction.||2.37|-2.88|=0.8472
72373303|NCT03745820|144257544|SUPERIORITY||LS Mean Difference|-0.33|STANDARD_ERROR_OF_MEAN|1.323|=|0.8053|TWO_SIDED|95.0|-2.94|2.29|||MMRM|||A MMRM model was used to analyze the change from baseline of the OM of interest, using fixed effects of treatment group, region, study visit, study visit-by-treatment interaction, baseline value of OM, baseline-by-visit interaction.||2.29|-2.94|=0.8053
72373304|NCT03745820|144257548|SUPERIORITY||LS Mean Difference|3.43|STANDARD_ERROR_OF_MEAN|1.835|=|0.0637|TWO_SIDED|95.0|-0.2|7.06|||ANCOVA|||An analysis of covariance (ANCOVA) model was applied adjusting for treatment group and baseline value of the OM.||7.06|-0.20|=0.0637
72373305|NCT03745820|144257548|SUPERIORITY||LS Mean Difference|3.42|STANDARD_ERROR_OF_MEAN|1.844|=|0.0659|TWO_SIDED|95.0|-0.23|7.06|||ANCOVA|||An ANCOVA model was applied adjusting for treatment group and baseline value of the OM.||7.06|-0.23|=0.0659
72373306|NCT03745820|144257549|SUPERIORITY||LS Mean Difference|0.208|STANDARD_ERROR_OF_MEAN|0.09|=|0.6653|TWO_SIDED|95.0|-0.32|0.5|||ANCOVA|||An ANCOVA model was applied adjusting for treatment group and baseline value of the OM.||0.50|-0.32|=0.6653
72373307|NCT03745820|144257549|SUPERIORITY||LS Mean Difference|0.206|STANDARD_ERROR_OF_MEAN|0.1|=|0.614|TWO_SIDED|95.0|-0.3|0.51|||ANCOVA|||An ANCOVA model was applied adjusting for treatment group and baseline value of the OM.||0.51|-0.30|=0.6140
72373308|NCT03745820|144257550|SUPERIORITY||LS Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|1.033|=|0.2886|TWO_SIDED|95.0|-3.14|0.94|||MMRM|||A MMRM model was used to analyze the change from baseline of the OM of interest, using fixed effects of treatment group, region, study visit, study visit-by-treatment interaction, baseline value of OM, baseline-by-visit interaction.||0.94|-3.14|=0.2886
72373309|NCT03745820|144257550|SUPERIORITY||LS Mean Difference|0.49|STANDARD_ERROR_OF_MEAN|1.032|=|0.6349|TWO_SIDED|95.0|-1.55|2.53|||MMRM|||A MMRM model was used to analyze the change from baseline of the OM of interest, using fixed effects of treatment group, region, study visit, study visit-by-treatment interaction, baseline value of OM, baseline-by-visit interaction.||2.53|-1.55|=0.6349
72373310|NCT03745820|144257551|SUPERIORITY||LS Mean Difference|0.45|STANDARD_ERROR_OF_MEAN|1.345|=|0.7372|TWO_SIDED|95.0|-2.21|3.11||A MMRM model was used to analyze the change from baseline of the OM of interest, using fixed effects of treatment group, region, study visit, study visit-by-treatment interaction, baseline value of OM, baseline-by-visit interaction.|MMRM|||Verbal Learning: Change From Baseline at Week 12||3.11|-2.21|=0.7372
72373311|NCT03745820|144257551|SUPERIORITY||LS Mean Difference|-0.54|STANDARD_ERROR_OF_MEAN|1.346|=|0.6894|TWO_SIDED|95.0|-3.2|2.12||A MMRM model was used to analyze the change from baseline of the OM of interest, using fixed effects of treatment group, region, study visit, study visit-by-treatment interaction, baseline value of OM, baseline-by-visit interaction.|MMRM|||Verbal Learning: Change From Baseline at Week 12||2.12|-3.20|=0.6894
72373312|NCT03745820|144257551|SUPERIORITY||LS Mean Difference|-2.14|STANDARD_ERROR_OF_MEAN|1.162|=|0.0674|TWO_SIDED|95.0|-4.44|0.16||A MMRM model was used to analyze the change from baseline of the OM of interest, using fixed effects of treatment group, region, study visit, study visit-by-treatment interaction, baseline value of OM, baseline-by-visit interaction.|MMRM|||Speed of Processing: Change From Baseline at Week 12||0.16|-4.44|=0.0674
72373313|NCT03745820|144257551|SUPERIORITY||LS Mean Difference|-0.43|STANDARD_ERROR_OF_MEAN|1.161|=|0.7132|TWO_SIDED|95.0|-2.72|1.87||A MMRM model was used to analyze the change from baseline of the OM of interest, using fixed effects of treatment group, region, study visit, study visit-by-treatment interaction, baseline value of OM, baseline-by-visit interaction.|MMRM|||Speed of Processing: Change From Baseline at Week 12||1.87|-2.72|=0.7132
72373314|NCT03745820|144257551|SUPERIORITY||LS Mean Difference|-0.09|STANDARD_ERROR_OF_MEAN|1.203|=|0.9428|TWO_SIDED|95.0|-2.46|2.29||A MMRM model was used to analyze the change from baseline of the OM of interest, using fixed effects of treatment group, region, study visit, study visit-by-treatment interaction, baseline value of OM, baseline-by-visit interaction.|MMRM|||Attention/Vigilance: Change From Baseline at Week 12||2.29|-2.46|=0.9428
72373315|NCT03745820|144257551|SUPERIORITY||LS Mean Difference|0.93|STANDARD_ERROR_OF_MEAN|1.202|=|0.4425|TWO_SIDED|95.0|-1.45|3.3||A MMRM model was used to analyze the change from baseline of the OM of interest, using fixed effects of treatment group, region, study visit, study visit-by-treatment interaction, baseline value of OM, baseline-by-visit interaction.|MMRM|||Attention/Vigilance: Change From Baseline at Week 12||3.30|-1.45|=0.4425
72373316|NCT03745820|144257551|SUPERIORITY||LS Mean Difference|-1.51|STANDARD_ERROR_OF_MEAN|1.597|=|0.3455|TWO_SIDED|95.0|-4.66|1.64||A MMRM model was used to analyze the change from baseline of the OM of interest, using fixed effects of treatment group, region, study visit, study visit-by-treatment interaction, baseline value of OM, baseline-by-visit interaction.|MMRM|||Visual Learning: Change From Baseline at Week 12||1.64|-4.66|=0.3455
72373317|NCT03745820|144257551|SUPERIORITY||LS Mean Difference|0.06|STANDARD_ERROR_OF_MEAN|1.595|=|0.9686|TWO_SIDED|95.0|-3.09|3.21||A MMRM model was used to analyze the change from baseline of the OM of interest, using fixed effects of treatment group, region, study visit, study visit-by-treatment interaction, baseline value of OM, baseline-by-visit interaction.|MMRM|||Visual Learning: Change From Baseline at Week 12||3.21|-3.09|=0.9686
72373318|NCT03745820|144257551|SUPERIORITY||LS Mean Difference|1.18|STANDARD_ERROR_OF_MEAN|1.351|=|0.3832|TWO_SIDED|95.0|-1.49|3.85||A MMRM model was used to analyze the change from baseline of the OM of interest, using fixed effects of treatment group, region, study visit, study visit-by-treatment interaction, baseline value of OM, baseline-by-visit interaction.|MMRM|||Social Cognition: Change From Baseline at Week 12||3.85|-1.49|=0.3832
72373319|NCT03745820|144257551|SUPERIORITY||LS Mean DIfference|1.07|STANDARD_ERROR_OF_MEAN|1.357|=|0.4297|TWO_SIDED|95.0|-1.61|3.75||A MMRM model was used to analyze the change from baseline of the OM of interest, using fixed effects of treatment group, region, study visit, study visit-by-treatment interaction, baseline value of OM, baseline-by-visit interaction.|MMRM|||Social Cognition: Change From Baseline at Week 12||3.75|-1.61|=0.4297
72373320|NCT03745820|144257551|SUPERIORITY||LS Mean Difference|-0.71|STANDARD_ERROR_OF_MEAN|1.438|=|0.6245|TWO_SIDED|95.0|-3.55|2.14||A MMRM model was used to analyze the change from baseline of the OM of interest, using fixed effects of treatment group, region, study visit, study visit-by-treatment interaction, baseline value of OM, baseline-by-visit interaction.|MMRM|||Reasoning and Problem Solving: Change From Baseline at Week 12||2.14|-3.55|=0.6245
72493663|NCT03048422|144516484|SUPERIORITY||Mean Difference (Final Values)|0.022||||0.11|TWO_SIDED|95.0|-0.005|0.048|||Generalized Estimating Equation|||Null hypothesis of no difference between arms (DTG+FTC/TAF - DTG+FTC/TDF).||0.048|-0.005|0.11
72373321|NCT03745820|144257551|SUPERIORITY||LS Mean Difference|1.59|STANDARD_ERROR_OF_MEAN|1.436|=|0.2698|TWO_SIDED|95.0|-1.25|4.43||A MMRM model was used to analyze the change from baseline of the OM of interest, using fixed effects of treatment group, region, study visit, study visit-by-treatment interaction, baseline value of OM, baseline-by-visit interaction.|MMRM|||Reasoning and Problem Solving: Change From Baseline at Week 12||4.43|-1.25|=0.2698
72373322|NCT03745820|144257552|SUPERIORITY||LS Mean Difference|-0.45|STANDARD_ERROR_OF_MEAN|0.61|=|0.4654|TWO_SIDED|95.0|-1.65|0.76||A MMRM model was used to analyze the change from baseline of the OM of interest, using fixed effects of treatment group, region, study visit, study visit-by-treatment interaction, baseline value of OM, baseline-by-visit interaction.|MMRM|||Positive Symptoms Subscale: Change From Baseline at Week 12||0.76|-1.65|=0.4654
72373323|NCT03745820|144257552|SUPERIORITY||LS Mean Difference|-0.33|STANDARD_ERROR_OF_MEAN|0.608|=|0.5886|TWO_SIDED|95.0|-1.53|0.87||A MMRM model was used to analyze the change from baseline of the OM of interest, using fixed effects of treatment group, region, study visit, study visit-by-treatment interaction, baseline value of OM, baseline-by-visit interaction.|MMRM|||Positive Symptoms Subscale: Change From Baseline at Week 12||0.87|-1.53|=0.5886
72373324|NCT03745820|144257552|SUPERIORITY||LS Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.655|=|0.9079|TWO_SIDED|95.0|-1.37|1.22||A MMRM model was used to analyze the change from baseline of the OM of interest, using fixed effects of treatment group, region, study visit, study visit-by-treatment interaction, baseline value of OM, baseline-by-visit interaction.|MMRM|||Negative Symptoms Subscale: Change From Baseline at Week 12||1.22|-1.37|=0.9079
72373325|NCT03745820|144257552|SUPERIORITY||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.65|=|0.4441|TWO_SIDED|95.0|-1.78|0.79||A MMRM model was used to analyze the change from baseline of the OM of interest, using fixed effects of treatment group, region, study visit, study visit-by-treatment interaction, baseline value of OM, baseline-by-visit interaction.|MMRM|||Negative Symptoms Subscale: Change From Baseline at Week 12||0.79|-1.78|=0.4441
72373326|NCT03745820|144257552|SUPERIORITY||LS Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|2.017|=|0.5537|TWO_SIDED|95.0|-5.18|2.79||A MMRM model was used to analyze the change from baseline of the OM of interest, using fixed effects of treatment group, region, study visit, study visit-by-treatment interaction, baseline value of OM, baseline-by-visit interaction.|MMRM|||Total Score: Change From Baseline at Week 12||2.79|-5.18|=0.5537
72373327|NCT03745820|144257552|SUPERIORITY||LS Mean Difference|-1.96|STANDARD_ERROR_OF_MEAN|2.018|=|0.332|TWO_SIDED|95.0|-5.95|2.02||A MMRM model was used to analyze the change from baseline of the OM of interest, using fixed effects of treatment group, region, study visit, study visit-by-treatment interaction, baseline value of OM, baseline-by-visit interaction.|MMRM|||Total Score: Change From Baseline at Week 12||2.02|-5.95|=0.3320
72373328|NCT03745820|144257553|SUPERIORITY||LS Mean Difference|0.02|STANDARD_ERROR_OF_MEAN|0.128|=|0.8517|TWO_SIDED|95.0|-0.23|0.28|||MMRM|||A MMRM model was used to analyze the change from baseline of the OM of interest, using fixed effects of treatment group, region, study visit, study visit-by-treatment interaction, baseline value of OM, baseline-by-visit interaction.||0.28|-0.23|=0.8517
72373329|NCT03745820|144257553|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.128|=|0.9952|TWO_SIDED|95.0|-0.25|0.25|||MMRM|||A MMRM model was used to analyze the change from baseline of the OM of interest, using fixed effects of treatment group, region, study visit, study visit-by-treatment interaction, baseline value of OM, baseline-by-visit interaction.||0.25|-0.25|=0.9952
72373330|NCT01410357|144257569|SUPERIORITY|||||||0.785||||||Bonferroni corrections were conducted to adjust for multiple comparisons.|Mixed Models Analysis|||||||.785
72373331|NCT01410357|144257570|SUPERIORITY|||||||0.016|||||||Mixed Models Analysis|A Bonferroni correction was conducted to adjust for multiple comparisons.||||||.016
72373332|NCT01410357|144257571|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|A Bonferroni correction was conducted to adjust for multiple comparisons.||||||<0.001
72373333|NCT01410357|144257572|SUPERIORITY|||||||0.003|||||||Mixed Models Analysis|A Bonferroni correction was conducted to adjust for multiple comparisons.||||||.003
72373334|NCT01410357|144257573|SUPERIORITY|||||||0.086|||||||Mixed Models Analysis|||||||.086
72373335|NCT01410357|144257574|SUPERIORITY|||||||0.872|||||||Mixed Models Analysis|A Bonferroni correction was conducted to adjust for multiple comparisons.||||||.872
72373336|NCT01410357|144257575|SUPERIORITY|||||||0.662|||||||Mixed Models Analysis|||||||.662
72373337|NCT01410357|144257576|SUPERIORITY|||||||0.633|||||||Mixed Models Analysis|||||||.633
72373338|NCT01410357|144257577|SUPERIORITY|||||||0.175|||||||Mixed Models Analysis|A Bonferroni correction was conducted to adjust for multiple comparisons.||||||.175
72373339|NCT01410357|144257578|SUPERIORITY|||||||0.68|||||||Mixed Models Analysis|A Bonferroni correction was conducted to adjust for multiple comparisons.||||||.680
72373340|NCT01410357|144257579|SUPERIORITY|||||||0.407|||||||Mixed Models Analysis|||||||.407
72373341|NCT01410357|144257580|SUPERIORITY|||||||0.87|||||||Mixed Models Analysis|||||||.870
72373342|NCT01410357|144257581|SUPERIORITY|||||||0.707|||||||Mixed Models Analysis|||||||.707
72373343|NCT01410357|144257582|SUPERIORITY|||||||0.838|||||||Mixed Models Analysis|||||||.838
72373344|NCT01410357|144257583|SUPERIORITY|||||||0.853|||||||Mixed Models Analysis|||||||.853
72373345|NCT01410357|144257584|SUPERIORITY|||||||0.853|||||||Mixed Models Analysis|||||||.853
72373346|NCT01410357|144257585|SUPERIORITY|||||||0.51|||||||Mixed Models Analysis|||||||.510
72373347|NCT01410357|144257586|SUPERIORITY|||||||0.573|||||||Mixed Models Analysis|||||||.573
72373348|NCT01410357|144257587|SUPERIORITY|||||||0.758|||||||Mixed Models Analysis|||||||.758
72373349|NCT01410357|144257588|SUPERIORITY|||||||0.156|||||||Mixed Models Analysis|||||||.156
72373350|NCT01410357|144257589|SUPERIORITY|||||||0.156|||||||Mixed Models Analysis|||||||.156
72373351|NCT01410357|144257590|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<.001
72373352|NCT01410357|144257591|SUPERIORITY|||||||0.878|||||||Mixed Models Analysis|||||||.878
72373353|NCT01410357|144257592|SUPERIORITY|||||||0.014|||||||Mixed Models Analysis|||||||.014
72373354|NCT01410357|144257593|SUPERIORITY|||||||0.227|||||||Mixed Models Analysis|||||||.227
72373355|NCT05498701|144257616|OTHER||Ratios of Adjusted Geometric Means|93.19|||||TWO_SIDED|90.0|87.1|99.7||||||Bioequivalence of the Test treatment (Tafamidis free acid 12.2 mg oral tablet \[Fasted\]) to Reference treatment (Tafamidis meglumine 20 mg oral capsule \[Fasted\]) was concluded if the 90% confidence intervals for the ratios of adjusted geometric means for tafamidis AUCinf fell entirely within the acceptance region of (80%,125%).||99.70|87.10|
72373356|NCT05498701|144257617|OTHER||Ratio of Adjusted Geometric Means|81.0||||||90.0|76.25|86.04||||||Bioequivalence of the Test treatment (Tafamidis free acid 12.2 mg oral tablet \[Fasted\]) to Reference treatment (Tafamidis meglumine 20 mg oral capsule \[Fasted\]) was concluded if the 90% confidence intervals for the ratios of adjusted geometric means for tafamidis Cmax fell entirely within the acceptance region of (80%,125%).||86.04|76.25|
72373357|NCT00600119|144257639|SUPERIORITY_OR_OTHER|||||||0.7781|||||||Wilcoxon (Mann-Whitney)|||||||0.7781
72432910|NCT01124162|144378500|NON_INFERIORITY_OR_EQUIVALENCE|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level.|Ratio of the T/R geometric mean x 100|101.5|||||TWO_SIDED|90.0|98.41|104.68|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||104.68|98.41|
72432911|NCT01124162|144378501|NON_INFERIORITY_OR_EQUIVALENCE|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level.|Ratio of the T/R geometric mean x 100|102.08|||||TWO_SIDED|90.0|98.24|106.06|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||106.06|98.24|
72432912|NCT01124162|144378502|NON_INFERIORITY_OR_EQUIVALENCE|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level.|Ratio of the T/R geometric mean x 100|100.31|||||TWO_SIDED|90.0|97.84|102.84|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||102.84|97.84|
72432913|NCT01124162|144378503|NON_INFERIORITY_OR_EQUIVALENCE|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level.|Ratio of the T/R geometric mean x 100|100.25|||||TWO_SIDED|90.0|97.87|102.69|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||102.69|97.87|
72432914|NCT02680756|144378504|NON_INFERIORITY|A 2-sided CI for difference in the proportions of Hb responders (risk difference for ferric maltol - IV iron) between the two treatment groups, and comparing the LCL of this CI to the pre-specified non-inferiority margin of 20%. The CI was calculated using the Delta Method approach based on a logistic regression model, adjusted for treatment group, baseline Hb (below the observed median or at least the observed median), and IBD subgroup (UC or CD).|Risk Difference (RD)|-0.17||||0.298|TWO_SIDED|95.0|-0.28|-0.06|||t-test, 2 sided|||||-0.06|-0.28|0.298
72432915|NCT02680756|144378505|NON_INFERIORITY|A 2-sided CI for difference in the proportions of Hb responders (risk difference for ferric maltol - IV iron) between the two treatment groups, and comparing the LCL of this CI to the pre-specified non-inferiority margin of 20%. The CI was calculated using the Delta Method approach based on a logistic regression model, adjusted for treatment group, baseline Hb (below the observed median or at least the observed median), and IBD subgroup (UC or CD).|Risk Difference (RD)|-0.17||||0.341|TWO_SIDED|95.0|-0.3|-0.05|||t-test, 2 sided|||||-0.05|-0.30|0.341
72432916|NCT03635112|144378532|SUPERIORITY||Least Square Mean Difference|-0.76||||0.97|TWO_SIDED|95.0|-40.62|39.11|||Mixed Model Repeated Measures Analysis|||||39.11|-40.62|0.970
72432917|NCT03635112|144378532|SUPERIORITY||Least Square Mean Difference|-13.13||||0.51|TWO_SIDED|95.0|-52.46|26.19|||Mixed Model Repeated Measures Analysis|||||26.19|-52.46|0.510
72432918|NCT03635112|144378533|SUPERIORITY||Difference in Proportion|-0.07||||0.5102|TWO_SIDED|95.0|-0.277|0.135|||Cochran-Mantel-Haenszel Chi-square Test|||||0.135|-0.277|0.5102
72432919|NCT03635112|144378533|SUPERIORITY||Difference in Proportion|0.02||||0.8591|TWO_SIDED|95.0|-0.181|0.218|||Cochran-Mantel-Haenszel Chi-square Test|||||0.218|-0.181|0.8591
72432920|NCT03635112|144378534|SUPERIORITY||Difference in Proportion|-0.13||||0.1805|TWO_SIDED|95.0|-0.322|0.061|||Cochran-Mantel-Haenszel Chi-square Test|||||0.061|-0.322|0.1805
72432921|NCT03635112|144378534|SUPERIORITY||Difference in Proportion|-0.01||||0.9215|TWO_SIDED|95.0|-0.204|0.184|||Cochran-Mantel-Haenszel Chi-square Test|||||0.184|-0.204|0.9215
72432922|NCT03635112|144378535|SUPERIORITY||Least Square Mean Difference|1.6||||0.316|TWO_SIDED|95.0|-1.6|4.8|||ANCOVA|||||4.8|-1.6|0.316
72432923|NCT03635112|144378535|SUPERIORITY||Least Square Mean Difference|0.0||||0.988|TWO_SIDED|95.0|-3.2|3.2|||ANCOVA|||||3.2|-3.2|0.988
72373358|NCT00600119|144257639|SUPERIORITY_OR_OTHER|||||||0.002|||||||Wilcoxon (Mann-Whitney)|||||||0.0020
72373359|NCT00600119|144257639|SUPERIORITY_OR_OTHER|||||||0.0001|||||||Wilcoxon (Mann-Whitney)|||||||0.0001
72373360|NCT00600119|144257640|SUPERIORITY_OR_OTHER|||||||0.5118|||||||Wilcoxon (Mann-Whitney)|||||||0.5118
72432924|NCT03635112|144378536|SUPERIORITY||Difference in Proportion|-0.11||||0.1828|TWO_SIDED|95.0|-0.27|0.059|||Cochran-Mantel-Haenszel Chi-square Test|||||0.059|-0.270|0.1828
72432925|NCT03635112|144378536|SUPERIORITY||Difference in Proportion|0.06||||0.5785|TWO_SIDED|95.0|-0.133|0.244|||Cochran-Mantel-Haenszel Chi-square Test|||||0.244|-0.133|0.5785
72432926|NCT03635112|144378537|SUPERIORITY||Difference in Proportion|-0.07||||0.3776|TWO_SIDED|95.0|-0.225|0.095|||Cochran-Mantel-Haenszel Chi-square Test|||||0.095|-0.225|0.3776
72432927|NCT03635112|144378537|SUPERIORITY||Difference in Proportion|-0.04||||0.6063|TWO_SIDED|95.0|-0.189|0.111|||Cochran-Mantel-Haenszel Chi-square Test|||||0.111|-0.189|0.6063
72373361|NCT00600119|144257640|SUPERIORITY_OR_OTHER|||||||0.0022|||||||Wilcoxon (Mann-Whitney)|||||||0.0022
72373362|NCT00600119|144257640|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
72432928|NCT03101592|144378550|NON_INFERIORITY|We estimated that approximately 5% of subjects would fail to be retained in care in the standard of care arm, and a retention rate \<7·5% to be non-inferior in the three-month or six-month study arms, with a 2·5% non-inferiority margin. Assuming an alpha of 0.05, power of 90%, and an intracluster correlation coefficient (ICC) of 0·004, we estimated a sample size of 271 subjects per cluster for a total of 2,710 subjects per arm and 8,130 total individuals.|Risk Difference (RD)|4.0|||||TWO_SIDED|95.0|-4.3|12.3|||||RD is for retention 3MD vs. SOC.|Our sample size was estimated for a cluster-randomized non-inferiority trial. We had 30 clusters available for randomization and assumed a fixed number of clusters (k), an equal number of clusters per arm, and an equal number of subjects per cluster.||12.3|-4.3|
72493664|NCT03048422|144516484|SUPERIORITY||Mean Difference (Final Values)|0.024||||0.055|TWO_SIDED|95.0|0.0|0.049|||Generalized Estimating Equation|||Null hypothesis of no difference between arms (DTG+FTC/TDF - EFV/FTC/TDF).||0.049|-0.000|0.055
72373363|NCT00600119|144257641|SUPERIORITY_OR_OTHER|||||||0.5522||||||Analysis for change in PAC-QOL Physical Discomfort domain from Baseline (Week 1) to end of treatment (Week 4).|Wilcoxon (Mann-Whitney)|||||||0.5522
72373364|NCT00600119|144257641|SUPERIORITY_OR_OTHER|||||||0.0589||||||Analysis for change in PAC-QOL Physical Discomfort domain from Baseline (Week 1) to end of treatment (Week 4).|Wilcoxon (Mann-Whitney)|||||||0.0589
72373365|NCT00600119|144257641|SUPERIORITY_OR_OTHER|||||||0.1691||||||Analysis for change in PAC-QOL Physical Discomfort domain from Baseline (Week 1) to end of treatment (Week 4).|Wilcoxon (Mann-Whitney)|||||||0.1691
72373366|NCT00600119|144257641|SUPERIORITY_OR_OTHER|||||||0.6293||||||Analysis for change in PAC-QOL Worries/Concerns domain from Baseline (Week 1) to end of treatment (Week 4).|Wilcoxon (Mann-Whitney)|||||||0.6293
72373367|NCT00600119|144257641|SUPERIORITY_OR_OTHER|||||||0.0836||||||Analysis for change in PAC-QOL Worries/Concerns domain from Baseline (Week 1) to end of treatment (Week 4).|Wilcoxon (Mann-Whitney)|||||||0.0836
72373368|NCT00600119|144257641|SUPERIORITY_OR_OTHER|||||||0.1155||||||Analysis for change in PAC-QOL Worries/Concerns domain from Baseline (Week 1) to end of treatment (Week 4).|Wilcoxon (Mann-Whitney)|||||||0.1155
72373369|NCT00600119|144257641|SUPERIORITY_OR_OTHER|||||||0.9938||||||Analysis for change in PAC-QOL Psychosocial Discomfort domain from Baseline (Week 1) to end of treatment (Week 4).|Wilcoxon (Mann-Whitney)|||||||0.9938
72373370|NCT00600119|144257641|SUPERIORITY_OR_OTHER|||||||0.2101||||||Analysis for change in PAC-QOL Psychosocial Discomfort domain from Baseline (Week 1) to end of treatment (Week 4).|Wilcoxon (Mann-Whitney)|||||||0.2101
72373371|NCT00600119|144257641|SUPERIORITY_OR_OTHER|||||||0.4597||||||Analysis for change in PAC-QOL Psychosocial Discomfort domain from Baseline (Week 1) to end of treatment (Week 4).|Wilcoxon (Mann-Whitney)|||||||0.4597
72373372|NCT00600119|144257641|SUPERIORITY_OR_OTHER|||||||0.4822||||||Analysis for change in PAC-QOL Satisfaction domain from Baseline (Week 1) to end of treatment (Week 4).|Wilcoxon (Mann-Whitney)|||||||0.4822
72373373|NCT00600119|144257641|SUPERIORITY_OR_OTHER|||||||0.0171||||||Analysis for change in PAC-QOL Satisfaction domain from Baseline (Week 1) to end of treatment (Week 4).|Wilcoxon (Mann-Whitney)|||||||0.0171
72373374|NCT00600119|144257641|SUPERIORITY_OR_OTHER|||||||0.016||||||Analysis for change in PAC-QOL Satisfaction domain from Baseline (Week 1) to end of treatment (Week 4).|Wilcoxon (Mann-Whitney)|||||||0.0160
72373375|NCT00600119|144257641|SUPERIORITY_OR_OTHER|||||||0.6857||||||Analysis for change in PAC-QOL Total Score from Baseline (Week 1) to end of treatment (Week 4).|Wilcoxon (Mann-Whitney)|||||||0.6857
72373376|NCT00600119|144257641|SUPERIORITY_OR_OTHER|||||||0.0253||||||Analysis for change in PAC-QOL Total Score from Baseline (Week 1) to end of treatment (Week 4).|Wilcoxon (Mann-Whitney)|||||||0.0253
72373377|NCT00600119|144257641|SUPERIORITY_OR_OTHER|||||||0.0772||||||Analysis for change in PAC-QOL Total Score from Baseline (Week 1) to end of treatment (Week 4).|Wilcoxon (Mann-Whitney)|||||||0.0772
72373378|NCT00600119|144257642|SUPERIORITY_OR_OTHER|||||||0.5008||||||Analysis for change in PAC-SYM Abdominal Symptoms domain from baseline (Week 1) to end of treatment (Week 4).|Wilcoxon (Mann-Whitney)|||||||0.5008
72373379|NCT00600119|144257642|SUPERIORITY_OR_OTHER|||||||0.1823||||||Analysis for change in PAC-SYM Abdominal Symptoms domain from baseline (Week 1) to end of treatment (Week 4).|Wilcoxon (Mann-Whitney)|||||||0.1823
72373380|NCT00600119|144257642|SUPERIORITY_OR_OTHER|||||||0.7045||||||Analysis for change in PAC-SYM Abdominal Symptoms domain from baseline (Week 1) to end of treatment (Week 4).|Wilcoxon (Mann-Whitney)|||||||0.7045
72373381|NCT00600119|144257642|SUPERIORITY_OR_OTHER|||||||0.7088||||||Analysis for change in PAC-SYM Rectal Symptoms domain from baseline (Week 1) to end of treatment (Week 4).|Wilcoxon (Mann-Whitney)|||||||0.7088
72373382|NCT00600119|144257642|SUPERIORITY_OR_OTHER|||||||0.5828||||||Analysis for change in PAC-SYM Rectal Symptoms domain from baseline (Week 1) to end of treatment (Week 4).|Wilcoxon (Mann-Whitney)|||||||0.5828
72373383|NCT00600119|144257642|SUPERIORITY_OR_OTHER|||||||0.0116||||||Analysis for change in PAC-SYM Rectal Symptoms domain from baseline (Week 1) to end of treatment (Week 4).|Wilcoxon (Mann-Whitney)|||||||0.0116
72373384|NCT00600119|144257642|SUPERIORITY_OR_OTHER|||||||0.7848||||||Analysis for change in PAC-SYM Stool Symptoms domain from baseline (Week 1) to end of treatment (Week 4).|Wilcoxon (Mann-Whitney)|||||||0.7848
72373385|NCT00600119|144257642|SUPERIORITY_OR_OTHER|||||||0.0335||||||Analysis for change in PAC-SYM Stool Symptoms domain from baseline (Week 1) to end of treatment (Week 4).|Wilcoxon (Mann-Whitney)|||||||0.0335
72373386|NCT00600119|144257642|SUPERIORITY_OR_OTHER|||||||0.0591||||||Analysis for change in PAC-SYM Stool Symptoms domain from baseline (Week 1) to end of treatment (Week 4).|Wilcoxon (Mann-Whitney)|||||||0.0591
72373387|NCT00600119|144257642|SUPERIORITY_OR_OTHER|||||||0.9317||||||Analysis for change in PAC-SYM Total Score from baseline (Week 1) to end of treatment (Week 4).|Wilcoxon (Mann-Whitney)|||||||0.9317
72373388|NCT00600119|144257642|SUPERIORITY_OR_OTHER|||||||0.0675||||||Analysis for change in PAC-SYM Total Score from baseline (Week 1) to end of treatment (Week 4).|Wilcoxon (Mann-Whitney)|||||||0.0675
72373389|NCT00600119|144257642|SUPERIORITY_OR_OTHER|||||||0.1745||||||Analysis for change in PAC-SYM Total Score from baseline (Week 1) to end of treatment (Week 4).|Wilcoxon (Mann-Whitney)|||||||0.1745
72432929|NCT03101592|144378550|NON_INFERIORITY|We estimated that approximately 5% of subjects would fail to be retained in care in the standard of care arm, and a retention rate \<7·5% to be non-inferior in the three-month or six-month study arms, with a 2·5% non-inferiority margin. Assuming an alpha of 0.05, power of 90%, and an intracluster correlation coefficient (ICC) of 0·004, we estimated a sample size of 271 subjects per cluster for a total of 2,710 subjects per arm and 8,130 total individuals.|Risk Difference (RD)|9.1|||||TWO_SIDED|95.0|0.9|17.2|||||RD is for retention 6MD vs. SOC.|Our sample size was estimated for a cluster-randomized non-inferiority trial. We had 30 clusters available for randomization and assumed a fixed number of clusters (k), an equal number of clusters per arm, and an equal number of subjects per cluster.||17.2|0.9|
72493665|NCT03048422|144516484|SUPERIORITY||Mean Difference (Final Values)|0.046|||<|0.001|TWO_SIDED|95.0|0.022|0.07|||Generalized Estimating Equation|||Null hypothesis of no difference between arms (DTG+FTC/TAF - EFV/FTC/TDF).||0.070|0.022|< 0.001
72493666|NCT03048422|144516485|SUPERIORITY||Mean Difference (Final Values)|0.023||||0.041|TWO_SIDED|95.0|0.001|0.045|||Generalized Estimating Equation|||Null hypothesis of no difference between arms (DTG+FTC/TAF - DTG+FTC/TDF).||0.045|0.001|0.041
72555354|NCT01929863|144642237|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-32.0|||||TWO_SIDED|95.0|-55.41|-8.58|||||The point estimate was calculated as least square mean difference (net values) of Treatment A-GSK2330672 + Metformin and Treatment B-Placebo + Metformin for AUC (4-10 h) Weighted Mean.|Treatment A-GSK2330672 + Metformin versus Treatment B-Placebo + Metformin for AUC (4-10 h) Weighted Mean.||-8.58|-55.41|
72432930|NCT03101592|144378550|NON_INFERIORITY|We estimated that approximately 5% of subjects would fail to be retained in care in the standard of care arm, and a retention rate \<7·5% to be non-inferior in the three-month or six-month study arms, with a 2·5% non-inferiority margin. Assuming an alpha of 0.05, power of 90%, and an intracluster correlation coefficient (ICC) of 0·004, we estimated a sample size of 271 subjects per cluster for a total of 2,710 subjects per arm and 8,130 total individuals.|Risk Difference (RD)|5.0|||||TWO_SIDED|95.0|1.0|9.1|||||RD is for retention 6MD vs. 3MD.|Our sample size was estimated for a cluster-randomized non-inferiority trial. We had 30 clusters available for randomization and assumed a fixed number of clusters (k), an equal number of clusters per arm, and an equal number of subjects per cluster.||9.1|1|
72432931|NCT03101592|144378550|NON_INFERIORITY|We estimated that approximately 5% of subjects would fail to be retained in care in the standard of care arm, and a retention rate \<7·5% to be non-inferior in the three-month or six-month study arms, with a 2·5% non-inferiority margin. Assuming an alpha of 0.05, power of 90%, and an intracluster correlation coefficient (ICC) of 0·004, we estimated a sample size of 271 subjects per cluster for a total of 2,710 subjects per arm and 8,130 total individuals.|Risk Difference (RD)|0.4|||||TWO_SIDED|95.0|-0.8|1.6|||||RD is for transfer 3MD vs. SOC.|Our sample size was estimated for a cluster-randomized non-inferiority trial. We had 30 clusters available for randomization and assumed a fixed number of clusters (k), an equal number of clusters per arm, and an equal number of subjects per cluster.||1.6|-0.8|
72432932|NCT03101592|144378550|NON_INFERIORITY|We estimated that approximately 5% of subjects would fail to be retained in care in the standard of care arm, and a retention rate \<7·5% to be non-inferior in the three-month or six-month study arms, with a 2·5% non-inferiority margin. Assuming an alpha of 0.05, power of 90%, and an intracluster correlation coefficient (ICC) of 0·004, we estimated a sample size of 271 subjects per cluster for a total of 2,710 subjects per arm and 8,130 total individuals.|Risk Difference (RD)|-0.1|||||TWO_SIDED|95.0|-0.9|0.8|||||RD is for transfer 6MD vs. SOC.|Our sample size was estimated for a cluster-randomized non-inferiority trial. We had 30 clusters available for randomization and assumed a fixed number of clusters (k), an equal number of clusters per arm, and an equal number of subjects per cluster.||0.8|-0.9|
72432933|NCT03101592|144378550|NON_INFERIORITY|We estimated that approximately 5% of subjects would fail to be retained in care in the standard of care arm, and a retention rate \<7·5% to be non-inferior in the three-month or six-month study arms, with a 2·5% non-inferiority margin. Assuming an alpha of 0.05, power of 90%, and an intracluster correlation coefficient (ICC) of 0·004, we estimated a sample size of 271 subjects per cluster for a total of 2,710 subjects per arm and 8,130 total individuals.|Risk Difference (RD)|-0.5|||||TWO_SIDED|95.0|-1.7|0.7|||||RD is for transfer 6MD vs. 3MD.|Our sample size was estimated for a cluster-randomized non-inferiority trial. We had 30 clusters available for randomization and assumed a fixed number of clusters (k), an equal number of clusters per arm, and an equal number of subjects per cluster.||0.7|-1.7|
72432934|NCT03101592|144378550|NON_INFERIORITY|We estimated that approximately 5% of subjects would fail to be retained in care in the standard of care arm, and a retention rate \<7·5% to be non-inferior in the three-month or six-month study arms, with a 2·5% non-inferiority margin. Assuming an alpha of 0.05, power of 90%, and an intracluster correlation coefficient (ICC) of 0·004, we estimated a sample size of 271 subjects per cluster for a total of 2,710 subjects per arm and 8,130 total individuals.|Risk Difference (RD)|-0.1|||||TWO_SIDED|95.0|-0.4|0.2|||||RD is for death 3MD vs. SOC.|Our sample size was estimated for a cluster-randomized non-inferiority trial. We had 30 clusters available for randomization and assumed a fixed number of clusters (k), an equal number of clusters per arm, and an equal number of subjects per cluster.||0.2|-0.4|
72432935|NCT03101592|144378550|NON_INFERIORITY|We estimated that approximately 5% of subjects would fail to be retained in care in the standard of care arm, and a retention rate \<7·5% to be non-inferior in the three-month or six-month study arms, with a 2·5% non-inferiority margin. Assuming an alpha of 0.05, power of 90%, and an intracluster correlation coefficient (ICC) of 0·004, we estimated a sample size of 271 subjects per cluster for a total of 2,710 subjects per arm and 8,130 total individuals.|Risk Difference (RD)|-0.1|||||TWO_SIDED|95.0|-0.9|0.8|||||RD is for death 6MD vs. SOC.|Our sample size was estimated for a cluster-randomized non-inferiority trial. We had 30 clusters available for randomization and assumed a fixed number of clusters (k), an equal number of clusters per arm, and an equal number of subjects per cluster.||0.8|-0.9|
72432936|NCT03101592|144378550|NON_INFERIORITY|We estimated that approximately 5% of subjects would fail to be retained in care in the standard of care arm, and a retention rate \<7·5% to be non-inferior in the three-month or six-month study arms, with a 2·5% non-inferiority margin. Assuming an alpha of 0.05, power of 90%, and an intracluster correlation coefficient (ICC) of 0·004, we estimated a sample size of 271 subjects per cluster for a total of 2,710 subjects per arm and 8,130 total individuals.|Risk Difference (RD)|0.0|||||TWO_SIDED|95.0|-0.3|0.3|||||RD is for death 6MD vs. 3MD.|Our sample size was estimated for a cluster-randomized non-inferiority trial. We had 30 clusters available for randomization and assumed a fixed number of clusters (k), an equal number of clusters per arm, and an equal number of subjects per cluster.||0.3|-0.3|
72432937|NCT02341534|144378553|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.21|TWO_SIDED|95.0|0.64|1.1|||Log Rank|||||1.10|0.64|0.21
72432938|NCT01648283|144378581|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<0.05
72432939|NCT00601640|144378590|SUPERIORITY_OR_OTHER|||||||0.022||95.0|||||Fisher Exact|||||||0.022
72555355|NCT01929863|144642237|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-40.96|||||TWO_SIDED|95.0|-66.64|-15.29|||||The point estimate was calculated as least square mean difference (net values) of Treatment A-GSK2330672 + Metformin and Treatment B-Placebo + Metformin for AUC (10-14 h) Weighted Mean.|Treatment A-GSK2330672 + Metformin versus Treatment B-Placebo + Metformin for AUC (10-14 h) Weighted Mean.||-15.29|-66.64|
72373390|NCT01270802|144257669|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.81|STANDARD_ERROR_OF_MEAN|0.76||0.67|TWO_SIDED|95.0|-0.75|2.37||P-value was not adjusted for multiple comparisons; P\<0.05 was considered statistically significant.|t-test, 2 sided|||We assumed that the declines in FMD seen with TDF/FTC/EFV in our previous study would fully reverse. Thus, the clinically relevant effect size to be detected for FMD change was +3.12% (SD 4%) in those switching from EFV to RAL. Using a two-sample, independent, two-tailed t-test with 5% type I error and 20% type II error, a sample size of 13 per group would be needed to find a difference in FMD between groups. Allowing for a 10% dropout rate, we planned to recruit 15 subjects per group.||2.37|-0.75|0.67
72373391|NCT01270802|144257670|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.63|STANDARD_ERROR_OF_MEAN|5.52||0.4|TWO_SIDED|95.0|-13.04|9.77||P-value was not adjusted for multiple comparisons. P\<0.05 was considered statistically significant.|t-test, 2 sided|||||9.77|-13.04|0.40
72373392|NCT01960907|144257687|SUPERIORITY_OR_OTHER|||||||0.342|||||||Log Rank|||||||0.342
72373393|NCT01960907|144257688|SUPERIORITY_OR_OTHER|||||||0.915|||||||t-test, 2 sided|||||||0.915
72373394|NCT01960907|144257689|SUPERIORITY_OR_OTHER|||||||0.038|||||||Wilcoxon (Mann-Whitney)|||||||0.038
72373395|NCT01616693|144257690|SUPERIORITY||Difference in seroconversion proportion|4.4|||||TWO_SIDED|97.5|-4.4|13.2||||||||13.2|-4.4|
72373396|NCT01616693|144257690|SUPERIORITY||Difference in seroconversion proportion|7.5|||||TWO_SIDED|95.0|-1.4|16.2||||||||16.2|-1.4|
72373397|NCT01616693|144257690|SUPERIORITY||Difference in seroconversion proportion|12.0|||||TWO_SIDED|95.0|0.8|22.8||||||||22.8|.8|
72373398|NCT01616693|144257692|SUPERIORITY||Mean Difference (Net)|1.1|||||TWO_SIDED|95.0|-4.3|6.6||||||||6.6|-4.3|
72432940|NCT05822440|144378648|OTHER||Ratio of Adjusted Geometric Means|124.35|||||TWO_SIDED|90.0|100.22|154.29||||||Ratio was between test to reference, where test is PF-07817883 + Itraconazole arm and reference is PF-07817883 arm. Natural log transformed Cmax of PF-07817883 were analyzed using a mixed effect model with treatment as fixed effect and participant as a random effect. The ratios (and 90% CIs) were expressed as percentages.||154.29|100.22|
72432941|NCT05822440|144378649|OTHER||Ratio of Adjusted Geometric Means|212.83||||||90.0|183.76|246.5||||||Ratio was between test to reference, where test is PF-07817883 + Itraconazole arm and reference is PF-07817883 arm. Natural log transformed Cmax of PF-07817883 were analyzed using a mixed effect model with treatment as fixed effect and participant as a random effect. The ratios (and 90% CIs) were expressed as percentages.||246.50|183.76|
72373399|NCT01616693|144257692|SUPERIORITY||Mean Difference (Net)|-3.1|||||TWO_SIDED|95.0|-8.6|2.3||||||||2.3|-8.6|
72373400|NCT01616693|144257692|SUPERIORITY||Mean Difference (Net)|-2.0|||||TWO_SIDED|95.0|-9.8|5.7||||||||5.7|-9.8|
72373401|NCT02395172|144257698|SUPERIORITY||Hazard Ratio (HR)|0.87|||=|0.0721|TWO_SIDED|95.0|0.71|1.05|||Log Rank|||||1.05|0.71|= 0.0721
72373402|NCT02395172|144257699|SUPERIORITY||Hazard Ratio (HR)|0.9|||||TWO_SIDED|95.0|0.77|1.05||||||||1.05|0.77|
72373403|NCT02395172|144257700|SUPERIORITY||Hazard Ratio (HR)|1.01|||||TWO_SIDED|95.0|0.8|1.27||||||||1.27|0.80|
72373404|NCT02395172|144257701|SUPERIORITY||Hazard Ratio (HR)|1.17|||||TWO_SIDED|95.0|0.98|1.41||||||||1.41|0.98|
72373405|NCT02395172|144257704|SUPERIORITY||Odds Ratio (OR)|1.4|||||TWO_SIDED|95.0|0.92|2.13||||||||2.13|0.92|
72373406|NCT02395172|144257705|SUPERIORITY||Odds Ratio (OR)|1.76|||||TWO_SIDED|95.0|1.08|2.86||||||||2.86|1.08|
72432942|NCT02387749|144378667|SUPERIORITY|||||||0.005|||||||Chi-squared, Corrected|||||||0.005
72432943|NCT03184428|144378761|OTHER||||||<|0.05|||||||Spearman's rank-order correlation|Bonferroni adjustment in addition||||||<0.05
72373407|NCT00475982|144257760|SUPERIORITY||Mean Difference (Final Values)|0.965||||0.965|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||0.965
72373408|NCT00475982|144257761|SUPERIORITY||Mean Difference (Final Values)|0.884||||0.884|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||0.884
72373409|NCT00475982|144257762|SUPERIORITY|||||||0.294|||||||paired t-test|||intra-analysis within the weight loss arm||||0.294
72373410|NCT00475982|144257762|SUPERIORITY|||||||0.44|||||||paired t-test|||intra-analysis within the control arm||||0.440
72373411|NCT00475982|144257762|SUPERIORITY||Mean Difference (Net)|8.49||||0.186|TWO_SIDED|95.0|-4.31|21.3|||paired t-test|||analysis between the weight loss and control arms||21.3|-4.31|0.186
72373412|NCT00475982|144257763|SUPERIORITY|||||||0.162|||||||paired t-test|||intra-analysis within the weight loss arm||||0.162
72373413|NCT00475982|144257763|SUPERIORITY|||||||0.986|||||||paired t-test|||intra-analysis within the control arm||||0.986
72373414|NCT00475982|144257763|SUPERIORITY||Mean Difference (Net)|2.22||||0.353|TWO_SIDED|95.0|-2.58|7.02|||paired t-test|||analysis between the weight loss and control arms||7.02|-2.58|0.353
72373415|NCT00475982|144257764|SUPERIORITY|||||||0.283|||||||paired t-test|||intra-analysis within the weight loss arm||||0.283
72373416|NCT00475982|144257764|SUPERIORITY|||||||0.701|||||||paired t-test|||intra-analysis within the control arm||||0.701
72432944|NCT02926937|144378791|SUPERIORITY||Difference in Least Squares (LS) Mean|-0.69|||<|0.0001|TWO_SIDED|95.0|-0.975|-0.415|||ANCOVA|||The change from baseline to Week 26 is analyzed using ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.0, \>8.0%) at screening, randomization strata of mean SBP (\<130, ≥130 mmHg) at screening, and country as fixed effects, and baseline HbA1c as a covariate.||-0.415|-0.975|<0.0001
72373417|NCT00475982|144257764|SUPERIORITY||Mean Difference (Net)|0.77||||0.835|TWO_SIDED|95.0|-6.7|8.24|||paired t-test|||analysis between the intervention and control arms||8.24|-6.70|0.835
72373418|NCT00475982|144257765|SUPERIORITY|||||||0|||||||paired t-test|||intra-analysis within the weight loss arm||||0.00
72373419|NCT00475982|144257765|SUPERIORITY|||||||0.009|||||||paired t-test|||intra-analysis within the control arm||||0.009
72373420|NCT00475982|144257765|SUPERIORITY||Mean Difference (Net)|2.11||||0.007|TWO_SIDED|95.0|0.64|3.59|||paired t-test|||analysis between the two arms||3.59|0.64|0.007
72373421|NCT00475982|144257766|SUPERIORITY|||||||0.073|||||||paired t-test|||intra-analysis within the weight loss arm||||0.073
72373422|NCT00475982|144257766|SUPERIORITY|||||||0.207|||||||paired t-test|||intra-analysis within the control arm||||0.207
72373423|NCT00475982|144257766|SUPERIORITY||Mean Difference (Net)|1.34||||0.063|TWO_SIDED|95.0|-0.08|2.75|||paired t-test|||analysis between the two arms||2.75|-0.08|0.063
72373424|NCT00783198|144257775|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.76||||0.0039|TWO_SIDED|95.0|-2.95|-0.57|||ANOVA||ANOVA model with baseline asthmatic condition, pollen region and treatment group as fixed effects|||-0.57|-2.95|0.0039
72373425|NCT00783198|144257775|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.24||||0.0002|TWO_SIDED|95.0|-3.41|-1.07|||ANOVA||ANOVA model with baseline asthmatic condition, pollen region and treatment group as fixed effects|||-1.07|-3.41|0.0002
72373426|NCT00783198|144257776|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.09||||0.032|TWO_SIDED|95.0|-2.08|-0.09|||ANOVA||ANOVA model with baseline asthmatic condition, pollen region and treatment group as fixed effects|||-0.09|-2.08|0.0320
72373427|NCT00783198|144257776|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.8||||0.0003|TWO_SIDED|95.0|-2.78|-0.82|||ANOVA||ANOVA model with baseline asthmatic condition, pollen region and treatment group as fixed effects|||-0.82|-2.78|0.0003
72432945|NCT02926937|144378792|SUPERIORITY||Difference in LS Mean|-0.565||||0.0141|TWO_SIDED|95.0|-1.0166|-0.114|||ANCOVA|||The change from baseline to Week 26 is analyzed using ANCOVA model with treatment groups randomization strata of HbA1c (≤8.0, \>8.0%) at screening, randomization strata of mean SBP (\<130, ≥130 mmHg) at screening, country, treatment-by-country as fixed effects, and baseline HbA1c as a covariate.||-0.1140|-1.0166|0.0141
72373428|NCT00783198|144257777|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.78||||0.0472|TWO_SIDED|95.0|-1.54|-0.01|||ANOVA||ANOVA model with baseline asthmatic condition, pollen region and treatment group as fixed effects|||-0.01|-1.54|0.0472
72373429|NCT00783198|144257777|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.94||||0.0144|TWO_SIDED|95.0|-1.7|-0.19|||ANOVA||ANOVA model with baseline asthmatic condition, pollen region and treatment group as fixed effects|||-0.19|-1.70|0.0144
72373430|NCT00783198|144257778|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.46||||0.1686|TWO_SIDED|95.0|-1.11|0.19|||ANOVA||ANOVA model with baseline asthmatic condition, pollen region and treatment group as fixed effects|||0.19|-1.11|0.1686
72373431|NCT00783198|144257778|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.82||||0.0125|TWO_SIDED|95.0|-1.46|-0.18|||ANOVA||ANOVA model with baseline asthmatic condition, pollen region and treatment group as fixed effects|||-0.18|-1.46|0.0125
72373432|NCT00783198|144257779|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.98||||0.0039|TWO_SIDED|95.0|-1.65|-0.32|||ANOVA||ANOVA model with baseline asthmatic condition, pollen region and treatment group as fixed effects|||-0.32|-1.65|0.0039
72373433|NCT00783198|144257779|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.3||||0.0001|TWO_SIDED|95.0|-1.95|-0.64|||ANOVA||ANOVA model with baseline asthmatic condition, pollen region and treatment group as fixed effects|||-0.64|-1.95|0.0001
72373434|NCT00791817|144257781|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.3897|||||TWO_SIDED|90.0|1.1998|1.6097||||Confidence Interval is on the Ratio of Fed to Fasted|Confidence Interval is on the Ratio of Fed to Fasted|values are Geometric Means and Confidence Intervals are on the Ratio of Fed to Fasted||1.6097|1.1998|
72373435|NCT01134705|144257797|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.84|||<|0.001|TWO_SIDED|95.0|-1.2|-0.5||A priori threshold for statistical significance is p\<0.05|Repeated measures Analysis of covariance|The repeated measures ANCOVA included covariate adjustment for baseline, day, treatment, and the treatment by day interaction.||||-0.5|-1.2|<0.001
72373436|NCT01134705|144257798|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.78|||<|0.001|TWO_SIDED|95.0|-1.1|-0.4||A priori threshold for statistical significance is p\<0.05|Repeated measures ANCOVA|The repeated measures ANCOVA included covariate adjustment for baseline, day, treatment, and the treatment by day interaction.||||-0.4|-1.1|<0.001
72373437|NCT01134705|144257799|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.58||||0.001|TWO_SIDED|95.0|-0.9|-0.2||A priori threshold for statistical significance is p\<0.05|ANCOVA|ANCOVA with treatment, baseline and center in the model.||||-0.2|-0.9|0.001
72373438|NCT04784442|144257800|SUPERIORITY|The overall Type I error rate will be controlled by performing comparison versus the placebo group starting from the highest ETC 1002 dose group by a closed testing procedure at a two-sided significance level of 0.05.|Least squares mean difference|-19.35|STANDARD_ERROR_OF_MEAN|2.768|<|0.001|TWO_SIDED|95.0|-24.81|-13.88|||ANCOVA||The least squares mean difference was calculated as the value for the ETC-1002 180 mg arm minus the value for the placebo arm.|||-13.88|-24.81|<0.001
72373439|NCT04784442|144257800|SUPERIORITY||Least squares mean difference|-19.93|STANDARD_ERROR_OF_MEAN|2.798|<|0.001|TWO_SIDED|95.0|-25.45|-14.41|||ANCOVA||The least squares mean difference was calculated as the value for the ETC-1002 120 mg arm minus the value for the placebo arm.|||-14.41|-25.45|<0.001
72373440|NCT04784442|144257800|SUPERIORITY||Least squares mean difference|-8.67|STANDARD_ERROR_OF_MEAN|2.813||0.002|TWO_SIDED|95.0|-14.22|-3.12|||ANCOVA||||The least squares mean difference was calculated as the value for the ETC-1002 60 mg arm minus the value for the placebo arm.|-3.12|-14.22|0.002
72373441|NCT01008423|144257817|SUPERIORITY||||||<|0.0001||||||Threshold for significance at 0.05 level.|Regression, Logistic|||The logistic regression test was used to test for a difference in the percentages between the 2 treatment arms after adjusting for analysis center (country).||||<0.0001
72373442|NCT00934843|144257832|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.78||||0.35|TWO_SIDED|95.0|0.45|1.33|||Multivariate risk computation|||The current study was designed with an anticipated enrollment of 87 patients per treatment arm to achieve a statistical power of 80% (1- β) while controlling type I error at 0.05 (α) using a more conservative estimate of LCOS rate in the Single Dose MP group of 33%, and an incidence of LCOS in the Two Dose MP group of 15%.||1.33|0.45|0.35
72373443|NCT00934843|144257833|SUPERIORITY_OR_OTHER|||||||0.43||95.0||||A repeated measures analysis of variance framework was used for longitudinal analysis of inotrope score. In order to identify potential confounding variables, a variable was considered a relevant covariate and added into the model with a p ≤ 0.15.|ANCOVA|||||||0.43
72373444|NCT00934843|144257835|SUPERIORITY_OR_OTHER|||||||0.052||95.0||||Analysis of variance/covariance models were used to test both unadjusted and multivariable relationships between treatment groups for diuresis.|ANCOVA|||||||0.052
72373445|NCT00934843|144257836|SUPERIORITY_OR_OTHER|||||||0.047||95.0|||||ANCOVA|Analysis of variance/covariance models were used to test both unadjusted and multivariable relationships between treatment groups for diuresis.||||||0.047
72373446|NCT03456882|144257837|SUPERIORITY|||||||0.6346||||||Significance level set to 0.05|repeated measures ANOVA|Repeated measures ANOVA with unstructured variance covariance matrix. Independent variables: time, treatment and treatment\*time interaction||Global test of treatment\*time interaction effect. Null hypothesis: the change over time is not different between groups.||||0.6346
72373447|NCT03456882|144257837|SUPERIORITY||Mean Difference (Net)|2.4|STANDARD_ERROR_OF_MEAN|2.6||0.3585|TWO_SIDED|||||Significance level set to 0.05|repeated measures ANOVA|Repeated measures ANOVA with unstructured variance covariance matrix. Independent variables: time, treatment and treatment\*time interaction.|RNS60 vs. Placebo|Contrast between treatment groups of the differences (week 24 - baseline) within treatment groups. Null hypothesis: the change from baseline to week 24 is not different between treatment groups.||||0.3585
72373448|NCT03456882|144257838|SUPERIORITY|||||||0.4388||||||Significance level set to 0.05|repeated measures ANOVA|Repeated measures ANOVA with unstructured variance covariance matrix. Independent variables: time, treatment and treatment\*time interaction.||Global test of treatment\*time interaction effect. Null hypothesis: the change over time is not different between groups.||||0.4388
72373449|NCT03456882|144257838|SUPERIORITY||Mean Difference (Net)|-0.3|STANDARD_ERROR_OF_MEAN|20.2||0.9887|TWO_SIDED|||||Significance level set to 0.05|repeated measures ANOVA|Repeated measures ANOVA with unstructured variance covariance matrix. Independent variables: time, treatment and treatment\*time interaction.|RNS60 vs. Placebo|Contrast between treatment groups of the differences (week 24 - baseline) within treatment groups. Null hypothesis: the change from baseline to week 24 is not different between treatment groups.||||0.9887
72373450|NCT03456882|144257839|SUPERIORITY|||||||0.9622||||||Significance level set to 0.05|repeated measures ANOVA|Repeated measures ANOVA with unstructured variance covariance matrix. Independent variables: time, treatment and treatment\*time interaction.||Global test of treatment\*time interaction effect. Null hypothesis: the change over time is not different between groups.||||0.9622
72373451|NCT03456882|144257839|SUPERIORITY||Mean Difference (Net)|6.5|STANDARD_ERROR_OF_MEAN|14.3||0.6533|TWO_SIDED|||||Significance level set to 0.05|repeated measures ANOVA|Repeated measures ANOVA with unstructured variance covariance matrix. Independent variables: time, treatment and treatment\*time interaction.|RNS60 vs. Placebo|Contrast between treatment groups of the differences (week 24 - baseline) within treatment groups. Null hypothesis: the change from baseline to week 24 is not different between treatment groups.||||0.6533
72373452|NCT03456882|144257840|SUPERIORITY|||||||0.9137||||||Significance level set to 0.05|repeated measures ANOVA|Repeated measures ANOVA with unstructured variance covariance matrix. Independent variables: time, treatment and treatment\*time interaction.||Global test of treatment\*time interaction effect. Null hypothesis: the change over time is not different between groups.||||0.9137
72373453|NCT03456882|144257840|SUPERIORITY||Mean Difference (Net)|16.7|STANDARD_ERROR_OF_MEAN|19.7||0.3985|TWO_SIDED|||||Significance level set to 0.05|repeated measures ANOVA|Repeated measures ANOVA with unstructured variance covariance matrix. Independent variables: time, treatment and treatment\*time interaction.|RNS60 vs. Placebo|Contrast between treatment groups of the differences (week 24 - baseline) within treatment groups. Null hypothesis: the change from baseline to week 24 is not different between treatment groups.||||0.3985
72373454|NCT03456882|144257841|SUPERIORITY|||||||0.2543||||||Significance level set to 0.05|repeated measures ANOVA|Repeated measures ANOVA with unstructured variance covariance matrix. Independent variables: time, treatment and treatment\*time interaction.||Global test of treatment\*time interaction effect. Null hypothesis: the change over time is not different between groups.||||0.2543
72373455|NCT03456882|144257841|SUPERIORITY||Mean Difference (Net)|-0.27|STANDARD_ERROR_OF_MEAN|0.22||0.2209|TWO_SIDED|||||Significance level set to 0.05|repeated measures ANOVA|Repeated measures ANOVA with unstructured variance covariance matrix. Independent variables: time, treatment and treatment\*time interaction.|RNS60 vs. Placebo|Contrast between treatment groups of the differences (week 24 - baseline) within treatment groups. Null hypothesis: the change from baseline to week 24 is not different between treatment groups.||||0.2209
72373456|NCT03456882|144257842|SUPERIORITY|||||||0.2738||||||Significance level set to 0.05|repeated measures ANOVA|Repeated measures ANOVA with unstructured variance covariance matrix. Independent variables: time, treatment and treatment\*time interaction||Global test of treatment\*time interaction effect. Null hypothesis: the change over time is not different between groups.||||0.2738
72373457|NCT03456882|144257842|SUPERIORITY||Mean Difference (Net)|-2.9|STANDARD_ERROR_OF_MEAN|3.7||0.4239|TWO_SIDED|||||Significance level set to 0.05|repeated measures ANOVA|Repeated measures ANOVA with unstructured variance covariance matrix. Independent variables: time, treatment and treatment\*time interaction.|RNS60 vs. Placebo|Contrast between treatment groups of the differences (week 24 - baseline) within treatment groups. Null hypothesis: the change from baseline to week 24 is not different between treatment groups.||||0.4239
72373458|NCT03456882|144257843|SUPERIORITY|||||||0.1708||||||Significance level set to 0.05|repeated measures ANOVA|Repeated measures ANOVA with unstructured variance covariance matrix. Independent variables: time, treatment and treatment\*time interaction.||Global test of treatment\*time interaction effect. Null hypothesis: the change over time is not different between groups.||||0.1708
72373459|NCT03456882|144257843|SUPERIORITY||Mean Difference (Net)|0.06|STANDARD_ERROR_OF_MEAN|0.25||0.8133|TWO_SIDED|||||Significance level set to 0.05|repeated measures ANOVA|Repeated measures ANOVA with unstructured variance covariance matrix. Independent variables: time, treatment and treatment\*time interaction.|RNS60 vs. Placebo|Contrast between treatment groups of the differences (week 24 - baseline) within treatment groups. Null hypothesis: the change from baseline to week 24 is not different between treatment groups.||||0.8133
72373460|NCT03456882|144257844|SUPERIORITY|||||||0.5239||||||Significance level set to 0.05|repeated measures ANOVA|Repeated measures ANOVA with unstructured variance covariance matrix. Independent variables: time, treatment and treatment\*time interaction.||Global test of treatment\*time interaction effect. Null hypothesis: the change over time is not different between groups.||||0.5239
72555356|NCT01929863|144642237|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-34.76|||||TWO_SIDED|95.0|-54.67|-14.85|||||The point estimate was calculated as least square mean difference (net values) of Treatment A-GSK2330672 + Metformin and Treatment B-Placebo + Metformin for AUC (0-24 h) Weighted Mean.|Treatment A-GSK2330672 + Metformin versus Treatment B-Placebo + Metformin for AUC (0-24 h) Weighted Mean.||-14.85|-54.67|
72373461|NCT03456882|144257844|SUPERIORITY||Mean Difference (Net)|0.09|STANDARD_ERROR_OF_MEAN|0.12||0.4401|TWO_SIDED|||||Significance level set to 0.05|repeated measures ANOVA|Repeated measures ANOVA with unstructured variance covariance matrix. Independent variables: time, treatment and treatment\*time interaction.|RNS60 vs. Placebo|Contrast between treatment groups of the differences (week 24 - baseline) within treatment groups. Null hypothesis: the change from baseline to week 24 is not different between treatment groups.||||0.4401
72373462|NCT03456882|144257845|SUPERIORITY||difference between mean slopes|0.02|STANDARD_ERROR_OF_MEAN|0.04||0.5725|TWO_SIDED|||||Significance level set to 0.05|Mixed Models Analysis|Linear mixed model with random intercept,slope,unstructured variance covariance matrix.Independent variables:time,treatment,treatment\*time interaction||Contrast of the slopes during the on-treatment period (change per week, from baseline to week 24) between treatment groups. Null hypothesis: the rate of change from baseline to week 24 is not different between groups.||||0.5725
72555357|NCT01929863|144642238|SUPERIORITY_OR_OTHER||Ratio|1.013|||||TWO_SIDED|90.0|0.912|1.125|||||The point estimate was calculated as geometric least square mean ratio of Treatment A-GSK2330672 + Metformin and Treatment B-Placebo + Metformin for AUC (0-10 h).|||1.125|0.912|
72373463|NCT03456882|144257845|SUPERIORITY||difference between mean slopes|-0.02|STANDARD_ERROR_OF_MEAN|0.04||0.5728|TWO_SIDED|||||Significance level set to 0.05|Mixed Models Analysis|Linear mixed model with random intercept,slope,unstructured variance covariance matrix.Independent variables:time,treatment,treatment\*time interaction|RNS60 vs. Placebo|Contrast of the slopes during the off-treatment follow-up period (change per week, from week 24 to week 48) between treatment groups. Null hypothesis: the rate of change from week 24 to week 48 is not different between groups.||||0.5728
72373464|NCT03456882|144257846|SUPERIORITY|||||||0.9212||||||Significance level set to 0.05|Log Rank|||Null hypothesis: the survival curves over the on-treatment and the off-treatment follow-up period are not different between groups.||||0.9212
72373465|NCT03456882|144257847|SUPERIORITY||difference between mean slopes|0.41|STANDARD_ERROR_OF_MEAN|0.16||0.0101|TWO_SIDED|||||Significance level set to 0.05|Mixed Models Analysis|Linear mixed model with random intercept,slope,unstructured variance covariance matrix.Independent variables:time,treatment,treatment\*time interaction|RNS60 vs. Placebo|Contrast of the slopes during the on-treatment period (change per week, from baseline to week 24) between treatment groups. Null hypothesis: the rate of change from baseline to week 24 is not different between groups.||||0.0101
72373466|NCT03456882|144257847|SUPERIORITY||difference between mean slopes|0.09|STANDARD_ERROR_OF_MEAN|0.18||0.5924|TWO_SIDED|||||Significance level set to 0.05|Mixed Models Analysis|Linear mixed model with random intercept,slope,unstructured variance covariance matrix.Independent variables:time,treatment,treatment\*time interaction|RNS60 vs. Placebo|Contrast of the slopes during the off-treatment follow-up period (change per week, from week 24 to week 48) between treatment groups. Null hypothesis: the rate of change from week 24 to week 48 is not different between groups.||||0.5924
72373467|NCT03456882|144257848|SUPERIORITY|||||||0.9598||||||Significance level set to 0.05|Fisher Exact|||AE treatment discontinuation 4 weeks. Null hypothesis: the percentage of patients experiencing at least one adverse event leading to treatment discontinuation within 4 weeks is not different between groups||||0.9598
72373468|NCT03456882|144257848|SUPERIORITY|||||||0.939||||||Significance level set to 0.05|Fisher Exact|||AE treatment discontinuation 12 weeks. Null hypothesis: the percentage of patients experiencing at least one adverse event leading to treatment discontinuation within 12 weeks is not different between groups||||0.9390
72373469|NCT03456882|144257848|SUPERIORITY|||||||0.3442||||||Significance level set to 0.05|Fisher Exact|||AE treatment discontinuation 24 weeks. Null hypothesis: the percentage of patients experiencing at least one adverse event leading to treatment discontinuation within 24 weeks is not different between groups||||0.3442
72373470|NCT03456882|144257849|SUPERIORITY||difference between mean slopes|-0.13|STANDARD_ERROR_OF_MEAN|0.1||0.1503|TWO_SIDED|||||Significance level set to 0.05|Mixed Models Analysis|Linear mixed model with random intercept,slope,unstructured variance covariance matrix.Independent variables:time,treatment,treatment\*time interaction|RNS60 vs. Placebo|ALSAQ-40 physical mobility. Contrast of the slopes during the on-treatment and off-treatment follow-up period (change per week, from baseline to week 48) between treatment groups. Null hypothesis: the rate of change from baseline to week 48 is not different between groups.||||0.1503
72373471|NCT03456882|144257849|SUPERIORITY||difference between mean slopes|-0.12|STANDARD_ERROR_OF_MEAN|0.1||0.1556|TWO_SIDED|||||Significance level set to 0.05|Mixed Models Analysis|Linear mixed model with random intercept,slope,unstructured variance covariance matrix.Independent variables:time,treatment,treatment\*time interaction|RNS60 vs. Placebo|ALSAQ-40 ADL and independence.Contrast of the slopes during the on-treatment and off-treatment follow-up period (change per week, from baseline to week 48) between treatment groups. Null hypothesis: the rate of change from baseline to week 48 is not different between groups.||||0.1556
72373472|NCT03456882|144257849|SUPERIORITY||difference between mean slopes|-0.19|STANDARD_ERROR_OF_MEAN|0.1||0.0319|TWO_SIDED|||||Significance level set to 0.05|Mixed Models Analysis|Linear mixed model with random intercept,slope,unstructured variance covariance matrix.Independent variables:time,treatment,treatment\*time interaction|RNS60 vs. Placebo|ALSAQ-40 eating and drinking. Contrast of the slopes during the on-treatment and off-treatment follow-up period (change per week, from baseline to week 48) between treatment groups. Null hypothesis: the rate of change from baseline to week 48 is not different between groups.||||0.0319
72373473|NCT03456882|144257849|SUPERIORITY||difference between mean slopes|-0.04|STANDARD_ERROR_OF_MEAN|0.1||0.6419|TWO_SIDED|||||Significance level set to 0.05|Mixed Models Analysis|Linear mixed model with random intercept,slope,unstructured variance covariance matrix.Independent variables:time,treatment,treatment\*time interaction|RNS60 vs. Placebo|ALSAQ-40 communication. Contrast of the slopes during the on-treatment and off-treatment follow-up period (change per week, from baseline to week 48) between treatment groups. Null hypothesis: the rate of change from baseline to week 48 is not different between groups.||||0.6419
72373474|NCT03456882|144257849|SUPERIORITY||difference between mean slopes|0.07|STANDARD_ERROR_OF_MEAN|0.1||0.3951|TWO_SIDED|||||Significance level set to 0.05|Mixed Models Analysis|Linear mixed model with random intercept,slope,unstructured variance covariance matrix.Independent variables:time,treatment,treatment\*time interaction|RNS60 vs. Placebo|ALSAQ-40 emotional reactions. Contrast of the slopes during the on-treatment and off-treatment follow-up period (change per week, from baseline to week 48) between treatment groups. Null hypothesis: the rate of change from baseline to week 48 is not different between groups.||||0.3951
72373475|NCT03456882|144257850|SUPERIORITY||Mean Difference (Net)|-0.2|STANDARD_ERROR_OF_MEAN|3.8||0.9563|TWO_SIDED|||||Significance level set to 0.05|repeated measures ANOVA|Repeated measures ANOVA with unstructured variance covariance matrix. Independent variables: time, treatment and treatment\*time interaction.|RNS60 vs. Placebo|Contrast between treatment groups of the differences (week 48 - week 24) within treatment groups. Null hypothesis: the change from week 24 to week 48 is not different between treatment groups.||||0.9563
72432946|NCT02926937|144378793|SUPERIORITY||Difference in LS Mean|-0.346||||0.2081|TWO_SIDED|95.0|-0.8853|0.1928|||ANCOVA|||The change from baseline to Week 26 is analyzed using ANCOVA model with treatment groups under Amendment 1 randomization strata of HbA1c (≤8.0, \>8.0%) at screening, randomization strata of mean SBP (\<130, ≥130 mmHg) at screening, country, treatment-by-country as fixed effects, and baseline HbA1c as a covariate.||0.1928|-0.8853|0.2081
72493667|NCT03048422|144516485|SUPERIORITY||Mean Difference (Final Values)|0.034||||0.002|TWO_SIDED|95.0|0.013|0.055|||Generalized Estimating Equation|||Null hypothesis of no difference between arms (DTG+FTC/TDF - EFV/FTC/TDF).||0.055|0.013|0.002
72373476|NCT03456882|144257851|SUPERIORITY||Mean Difference (Net)|28.5|STANDARD_ERROR_OF_MEAN|23.4||0.2253|TWO_SIDED|||||Significance level set to 0.05|repeated measures ANOVA|Repeated measures ANOVA with unstructured variance covariance matrix. Independent variables: time, treatment and treatment\*time interaction.|RNS60 vs. Placebo|Contrast between treatment groups of the differences (week 48 - week 24) within treatment groups. Null hypothesis: the change from week 24 to week 48 is not different between treatment groups.||||0.2253
72373477|NCT03456882|144257852|SUPERIORITY||Mean Difference (Net)|-7.7|STANDARD_ERROR_OF_MEAN|15.7||0.6263|TWO_SIDED|||||Significance level set to 0.05|repeated measures ANOVA|Repeated measures ANOVA with unstructured variance covariance matrix. Independent variables: time, treatment and treatment\*time interaction.|RNS60 vs. Placebo|Contrast between treatment groups of the differences (week 48 - week 24) within treatment groups. Null hypothesis: the change from week 24 to week 48 is not different between treatment groups.||||0.6263
72373478|NCT03456882|144257853|SUPERIORITY||Mean Difference (Final Values)|-19.0|STANDARD_ERROR_OF_MEAN|21.0||0.3671|TWO_SIDED|||||Significance level set to 0.05|repeated measures ANOVA|Repeated measures ANOVA with unstructured variance covariance matrix. Independent variables: time, treatment and treatment\*time interaction.|RNS60 vs. Placebo|Contrast between treatment groups of the differences (week 48 - week 24) within treatment groups. Null hypothesis: the change from week 24 to week 48 is not different between treatment groups.||||0.3671
72373479|NCT03456882|144257854|SUPERIORITY||Mean Difference (Net)|-0.04|STANDARD_ERROR_OF_MEAN|0.22||0.845|TWO_SIDED|||||Significance level set to 0.05|repeated measures ANOVA|Repeated measures ANOVA with unstructured variance covariance matrix. Independent variables: time, treatment and treatment\*time interaction.|RNS60 vs. Placebo|Contrast between treatment groups of the differences (week 48 - week 24) within treatment groups. Null hypothesis: the change from week 24 to week 48 is not different between treatment groups.||||0.845
72373480|NCT03456882|144257855|SUPERIORITY||Mean Difference (Net)|-0.4|STANDARD_ERROR_OF_MEAN|0.32||0.2161|TWO_SIDED|||||Significance level set to 0.05|repeated measures ANOVA|Repeated measures ANOVA with unstructured variance covariance matrix. Independent variables: time, treatment and treatment\*time interaction.|RNS60 vs. Placebo|Contrast between treatment groups of the differences (week 48 - week 24) within treatment groups. Null hypothesis: the change from week 24 to week 48 is not different between treatment groups.||||0.2161
72373481|NCT03456882|144257856|SUPERIORITY||Mean Difference (Net)|0.1|STANDARD_ERROR_OF_MEAN|0.15||0.4962|TWO_SIDED|||||Significance level set to 0.05|repeated measures ANOVA|Repeated measures ANOVA with unstructured variance covariance matrix. Independent variables: time, treatment and treatment\*time interaction|RNS60 vs. Placebo|Contrast between treatment groups of the differences (week 48 - week 24) within treatment groups. Null hypothesis: the change from week 24 to week 48 is not different between treatment groups.||||0.4962
72373482|NCT03456882|144257857|SUPERIORITY|||||||0.8738||||||Significance level set to 0.05|Wilcoxon (Mann-Whitney)|||Mean AE treatment discontinuation 4 weeks. Null hypothesis: the number of adverse events occurred within 4 weeks is not different between groups||||0.8738
72373483|NCT03456882|144257857|SUPERIORITY|||||||0.7556||||||Significance level set to 0.05|Wilcoxon (Mann-Whitney)|||Mean AE treatment discontinuation 12 weeks. Null hypothesis: the number of adverse events occurred within 12 weeks is not different between groups||||0.7556
72373484|NCT03456882|144257857|SUPERIORITY|||||||0.6477||||||Significance level set to 0.05|Wilcoxon (Mann-Whitney)|||Mean AE treatment discontinuation 24 weeks. Null hypothesis: the number of adverse events occurred within 24 weeks is not different between groups||||0.6477
72373485|NCT03456882|144257857|SUPERIORITY|||||||0.6084||||||Significance level set to 0.05|Wilcoxon (Mann-Whitney)|||Mean AE treatment discontinuation 48 weeks. Null hypothesis: the number of adverse events occurred within 48 weeks is not different between groups||||0.6084
72373486|NCT00183729|144257871|SUPERIORITY||Mean Difference (Final Values)|2.0|STANDARD_ERROR_OF_MEAN|2.0||0.42|TWO_SIDED||||||Mixed Models Analysis|||Null: the two groups would not differ in depressive symptoms over time (ie both groups would improve equally in terms of their depressive symptoms) Power calculation: none; this was a pilot study||||0.42
72373487|NCT00183729|144257873|SUPERIORITY|(no comments)|Mean Difference (Final Values)|8.0|STANDARD_ERROR_OF_MEAN|7.0||0.06|TWO_SIDED||||||Mixed Models Analysis|||Null hypothesis: functional recovery would be the same in both groups. Power calculation: none. This was a pilot study.||||0.06
72373488|NCT03512457|144257874|SUPERIORITY|Chi-square||||||0.12||||||P-value of \<0.05 is the threshold for statistical significance. The hypothesis was that more women randomized to the intensive intervention would perform skin self-examination.|Chi-squared|Chi-Squared is equal to 1.58, with a P-Value of 0.12.||change from baseline to 3 months in performance of skin self-examination Parallel: response rate||||0.12
72373489|NCT03512457|144257875|SUPERIORITY|Types of lesions in the following categories: Benign nevus, seborrheic keratosis, lentigo, dermatofibroma, atypical nevus. melanoma|||||<|0.05|||||||Chi-squared|||results of skin clinical examination and biopsy of clinically suspicious moles||||<0.05
72373490|NCT03207035|144257909|OTHER|||||||0.03|||||||Wilcoxon (Mann-Whitney)|||||||0.03
72373491|NCT03207035|144257910|OTHER|||||||0.02|||||||t-test, 2 sided|||||||0.02
72373492|NCT03207035|144257911|OTHER|||||||0.7|||||||t-test, 2 sided|||||||0.70
72373493|NCT03207035|144257912|OTHER|||||||0.002|||||||t-test, 2 sided|||||||0.002
72373494|NCT03207035|144257913|OTHER|||||||0.001|||||||t-test, 2 sided|||||||0.001
72373495|NCT03207035|144257914|OTHER|||||||0.001|||||||t-test, 2 sided|||||||0.001
72373496|NCT03207035|144257915|OTHER|||||||0.53|||||||Chi-squared|||||||0.53
72373497|NCT03207035|144257916|OTHER|||||||0.48|||||||Chi-squared|||||||0.48
72373498|NCT01248104|144257924|SUPERIORITY_OR_OTHER_LEGACY|Continuous variables were compared by multivariate linear regression analysis to adjust for possible covariates of intraoperative fluids, age, bypass time, and procedure time. Tukey-Kramer test was then used to compare for specific differences between groups for each variable. Categorical data were compared using Fisher's exact test. All comparisons were made at a significance level of 0.05, and analysis was performed with Minitab version 17).||||||0.35||||||The primary outcome measure showed that there was no difference in PRBC transfusion frequency or amounts in the operating room or the in ICU up to POD 2|ANOVA|||A power analysis based on the comparison of a 15% difference in total transfusion amounts up to POD 2 between the treatment groups indicated a total sample size of 80 with a power of 0.8, confidence interval 0.9, and p= 0.05.||||0.35
72432947|NCT02926937|144378794|SUPERIORITY||Difference in LS Mean|-1.556|||<|0.0001|TWO_SIDED|95.0|-2.1876|-0.9234|||ANCOVA|||The change from baseline to Week 26 is analyzed using ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.0, \>8.0%) at screening, randomization strata of mean SBP (\<130, ≥ 130mmHg) at screening, and country as fixed effects, and baseline fasting plasma glucose as a covariate.||-0.9234|-2.1876|<0.0001
72432948|NCT02926937|144378795|SUPERIORITY||Difference in LS Mean|-3.5||||0.168|TWO_SIDED|95.0|-8.478|1.476|||ANCOVA|||The change from baseline to Week 12 is analyzed using analysis ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.0, \>8.0%) at screening and country as fixed effects, and baseline SBP as a covariate.||1.476|-8.478|0.1680
72432949|NCT02926937|144378796|SUPERIORITY||Difference in LS Mean|-0.78||||0.5467|TWO_SIDED|95.0|-3.311|1.753|||ANCOVA|||The change from baseline to Week 12 is analyzed using ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.0, \>8.0%) at screening, randomization strata of mean SBP (\<130, ≥130 mmHg) at screening, and country as fixed effects, and baseline SBP as a covariate.||1.753|-3.311|0.5467
72432950|NCT02926937|144378797|SUPERIORITY||Difference in LS Mean|-3.19||||0.0193|TWO_SIDED|95.0|-5.869|-0.518|||ANCOVA|||The change from baseline to Week 12 is analyzed using ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.0, \>8.0%) at screening, randomization strata of mean SBP (\<130, ≥130 mmHg) at screening, and country as fixed effects, and baseline SBP as a covariate.||-0.518|-5.869|0.0193
72432951|NCT02926937|144378798|SUPERIORITY||Difference in LS Mean|-1.54||||0.0005|TWO_SIDED|95.0|-2.404|-0.676|||ANCOVA|||The change from baseline to Week 26 is analyzed using ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.0, \>8.0%) at screening, randomization strata of mean SBP (\<130, ≥130 mmHg) at screening, and country as fixed effects, and baseline weight as a covariate.||-0.676|-2.404|0.0005
72432952|NCT02926937|144378799|SUPERIORITY||Difference in LS Mean|-1.17||||0.0406|TWO_SIDED|95.0|-2.281|-0.05|||ANCOVA|||The change from baseline to Week 26 is analyzed using ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.0, \>8.0%) at screening, randomization strata of mean SBP (\<130, ≥130mmHg) at screening, and country as fixed effects, and baseline weight as a covariate.||-0.050|-2.281|0.0406
72432953|NCT02926937|144378800|SUPERIORITY||Percentage Difference|12.6||||0.0037|TWO_SIDED|95.0|4.18|21.02|||Cochran-Mantel-Haenszel|||Percentage difference between treatment groups from each stratum (randomization strata of HbA1c (\<=8.0, \>8.0%) at screening, randomization strata of mean SBP (\<130, \>=130 mmHg) at screening) using Cochran-Mantel-Haenszel weights.||21.02|4.18|0.0037
72432954|NCT02926937|144378801|SUPERIORITY||Percentage Difference|19.2||||0.0007|TWO_SIDED|95.0|8.39|30.0|||Cochran-Mantel-Haenszel|||Percentage difference between treatment groups from each stratum (randomization strata of HbA1c (\<=8.0, \>8.0%) at screening, randomization strata of mean SBP (\<130, \>=130 mmHg) at screening) using Cochran-Mantel-Haenszel weights.||30.00|8.39|0.0007
72432955|NCT02926937|144378802|SUPERIORITY||Difference in LS Mean|-0.67|||<|0.0001|TWO_SIDED|95.0|-0.989|-0.354|||ANCOVA|||The change from baseline to Week 26 is analyzed using ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.0, \>8.0%) at screening, randomization strata of mean SBP (\<130, ≥130 mmHg) at screening, and country as fixed effects, and baseline HbA1c as a covariate.||-0.354|-0.989|<0.0001
72432956|NCT00126113|144378809|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||ANOVA|Analysis for main effect of group||||||>0.05
72432957|NCT00126113|144378810|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||Analysis for main effect of group|ANOVA|||||||>0.05
72432958|NCT00126113|144378811|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||ANOVA|Analysis for main effect of group||||||>0.05
72432959|NCT00126113|144378812|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||ANOVA|Analysis for main effect of group||||||>0.05
72432960|NCT00561574|144378815|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Two-sided significance level of 0.05|t-test, 2 sided|||||||<0.0001
72432961|NCT00561574|144378815|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Two-sided significance level of 0.05|t-test, 2 sided|||||||<0.0001
72432962|NCT00561574|144378816|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Two-sided significance level of 0.05|t-test, 2 sided|||||||<0.0001
72373499|NCT02908490|144257958|SUPERIORITY|Given the cross-over design, analyses included a random effects model for within-subject comparisons of sildenafil versus placebo periods, adjusting for the baseline FMD within that period and a term for treatment order.|Slope|-1.42||||0.185|TWO_SIDED|95.0|-3.54|0.68||The a priori threshold for statistical significance was \<0.05.|Mixed Models Analysis|||||0.68|-3.54|0.185
72373500|NCT02908490|144257959|SUPERIORITY|Given the cross-over design, analyses included a random effects model for within-subject comparisons of sildenafil versus placebo periods, adjusting for the baseline EndoPAT within that period and a term for treatment order.|Slope|0.2||||0.003|TWO_SIDED|95.0|0.069|0.331||The a priori threshold for statistical significance was \<0.05.|Mixed Models Analysis|||||0.331|0.069|0.003
72373501|NCT02908490|144257965|SUPERIORITY|Given the cross-over design, analyses included a random effects model for within-subject comparisons of sildenafil versus placebo periods, adjusting for the baseline biomarker within that period and a term for treatment order.|Slope|7.63||||0.061|TWO_SIDED|95.0|-0.36|15.63||The a prior threshold for statistical significance was \<0.05.|Mixed Models Analysis|||||15.63|-0.36|0.061
72432963|NCT00561574|144378816|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Two-sided significance level of 0.05|t-test, 2 sided|||||||<0.0001
72432964|NCT00561574|144378817|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Two-sided significance level of 0.05|t-test, 2 sided|||||||<0.0001
72432965|NCT00561574|144378817|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Two-sided significance level of 0.05|t-test, 2 sided|||||||<0.0001
72432966|NCT00561574|144378818|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3129||||||Two-sided significance level of 0.05|t-test, 2 sided|||||||0.3129
72432967|NCT00561574|144378818|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3154||||||Two-sided significance level of 0.05|t-test, 2 sided|||||||0.3154
72432968|NCT00561574|144378819|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Two-sided significance level of 0.05|t-test, 2 sided|||||||<0.0001
72432969|NCT00561574|144378819|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Two-sided significance level of 0.05|t-test, 2 sided|||||||<0.0001
72432970|NCT00561574|144378820|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Two-sided significance level of 0.05|t-test, 2 sided|||||||<0.0001
72432971|NCT00561574|144378820|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Two-sided significance level of 0.05|t-test, 2 sided|||||||<0.0001
72432972|NCT00561574|144378821|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Two-sided significance level of 0.05|t-test, 2 sided|||||||<0.0001
72373502|NCT02908490|144257966|SUPERIORITY|Given the cross-over design, analyses included a random effects model for within-subject comparisons of sildenafil versus placebo periods, adjusting for the baseline biomarker within that period and a term for treatment order.|Slope|55.3||||0.011|TWO_SIDED|95.0|12.79|97.81||The a prior threshold for statistical significance was \<0.05.|Mixed Models Analysis|||||97.81|12.79|0.011
72373503|NCT02908490|144257967|SUPERIORITY|Given the cross-over design, analyses included a random effects model for within-subject comparisons of sildenafil versus placebo periods, adjusting for the baseline biomarker within that period and a term for treatment order.|Slope|74.93||||0.077|TWO_SIDED|95.0|-7.98|157.84||The a priori threshold for statistical significance was \<0.05.|Mixed Models Analysis|||||157.84|-7.98|0.077
72373504|NCT03467152|144257976|SUPERIORITY|||||||0.6909||||||Mixed Models for Repeated Measures Analysis (MMRM)|MMRM|||||||0.6909
72373505|NCT03467152|144257977|SUPERIORITY||Odds Ratio (OR)|1.018||||0.8251|TWO_SIDED|95.0|0.695|1.492||Generalized Linear Mixed Models Analysis (GLMM)|GLMM|||||1.492|0.695|0.8251
72373506|NCT03467152|144257978|SUPERIORITY||Odds Ratio (OR)|0.853||||0.3003|TWO_SIDED|95.0|0.584|1.247||Generalized Linear Mixed Models Analysis (GLMM)|GLMM|||||1.247|0.584|0.3003
72373507|NCT03467152|144257979|SUPERIORITY|||||||0.9198||||||Mixed Models for Repeated Measures Analysis (MMRM)|MMRM|||||||0.9198
72373508|NCT03467152|144257980|SUPERIORITY|||||||0.2909|||||||ANCOVA|||||||0.2909
72373509|NCT03467152|144257981|SUPERIORITY|||||||0.6127||||||Mixed Models for Repeated Measures Analysis (MMRM)|MMRM|||||||0.6127
72373510|NCT03467152|144257982|SUPERIORITY|||||||0.878||||||Mixed Models for Repeated Measures Analysis (MMRM)|MMRM|||||||0.8780
72373511|NCT03467152|144257983|SUPERIORITY|||||||0.409||||||Mixed Models for Repeated Measures Analysis (MMRM)|MMRM|||||||0.4090
72373512|NCT03467152|144257984|SUPERIORITY|||||||0.8736||||||Mixed Models for Repeated Measures Analysis (MMRM)|MMRM|||||||0.8736
72373513|NCT01236547|144257992|SUPERIORITY||Hazard Ratio (HR)|0.86||||0.2831|TWO_SIDED|95.0|0.52|1.43||One-sided significance level = 0.1379|Log Rank||Reference arm = placebo|Assuming hazard ratio (pazopanib/placebo) of 0.625 (1-year 19% vs. 35.4%), 1-sided alpha 0.15, logrank test, 80% power, 1 interim analysis, required 71 deaths in 79 eligible patients (88 allowing 10% ineligible) in original design. The protocol was amended for phase II final analysis to be performed after all phase II eligible participants were potentially followed for 3 years with 1-sided alpha 0.1379, providing 77% power. See Limitations and Caveats||1.43|0.52|0.2831
72373514|NCT01236547|144257994|SUPERIORITY||Hazard Ratio (HR)|1.22||||0.688|TWO_SIDED|95.0|0.55|2.67|||Log Rank|One-sided significance level = 0.15|Reference arm = placebo|||2.67|0.55|0.6880
72373515|NCT01236547|144257995|SUPERIORITY|||||||0.1921||||||Two-sided significance level = 0.05|Fisher Exact|||||||0.1921
72373516|NCT01236547|144257996|SUPERIORITY|||||||1||||||Two-sided significance level = 0.05|Fisher Exact|||||||1.00
72373517|NCT01236547|144257997|SUPERIORITY|||||||1|||||||Fisher Exact|Two-sided significance level = 0.05||||||1.00
72373518|NCT00412373|144258010|SUPERIORITY_OR_OTHER||LS Mean Difference|0.5|STANDARD_ERROR_OF_MEAN|1.6||0.774||95.0|-2.7|3.7|||ANOVA|P-value based on the actual value and was from an ANOVA model with fixed effects for treatment, concomitant medication stratum, and country.|Paliperidone Extended Release (ER) - Placebo on the Actual Score.|||3.7|-2.7|0.774
72373519|NCT00412373|144258011|SUPERIORITY_OR_OTHER||LS Mean Difference|-9.4|STANDARD_ERROR_OF_MEAN|2.3|<|0.001||95.0|-13.8|-4.9|||ANCOVA|P-values are from an ANCOVA model with fixed effects for treatment, concomitant medication stratum, and country, and baseline value as a covariate.|Paliperidone Extended Release (ER) - Placebo on the Change Scores.|||-4.9|-13.8|<0.001
72373520|NCT00412373|144258012|SUPERIORITY_OR_OTHER||LS Means Difference|-2.8|STANDARD_ERROR_OF_MEAN|0.8|<|0.001||95.0|-4.4|-1.2|||ANCOVA|P-value is from an ANCOVA model with fixed effects for treatment, concomitant medication stratum, and country, and with baseline value as a covariate.|Paliperidone Extended Release (ER) - Placebo on the Change Scores.|||-1.2|-4.4|<0.001
72373521|NCT00412373|144258013|SUPERIORITY_OR_OTHER||LS Means Difference|-2.0|STANDARD_ERROR_OF_MEAN|0.6|<|0.001||95.0|-3.1|-0.8|||ANCOVA|P-value is from an ANCOVA model with fixed effects for treatment, concomitant medication stratum, and country, and with baseline value as a covariate.|Paliperidone Extended Release (ER) - Placebo on the Change Scores.|||-0.8|-3.1|<0.001
72373522|NCT00412373|144258014|SUPERIORITY_OR_OTHER||LS Means Difference|-4.5|STANDARD_ERROR_OF_MEAN|1.2|<|0.001||95.0|-6.8|-2.3|||ANCOVA|P-value is from an ANCOVA model with fixed effects for treatment, concomitant medication stratum, and country, and with baseline value as a covariate.|Paliperidone Extended Release (ER) - Placebo on the Change Scores.|||-2.3|-6.8|<0.001
72432973|NCT00561574|144378821|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0001||||||Two-sided significance level of 0.05|t-test, 2 sided|||||||0.0001
72432974|NCT00561574|144378822|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0116||||||Two-sided significance level of 0.05|t-test, 2 sided|||||||0.0116
72432975|NCT00561574|144378822|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0004||||||Two-sided significance level of 0.05|t-test, 2 sided|||||||0.0004
72373523|NCT00412373|144258015|SUPERIORITY_OR_OTHER||LS Means Difference|-2.7|STANDARD_ERROR_OF_MEAN|0.8|<|0.001||95.0|-4.2|-1.1|||ANCOVA|P-value is from an ANCOVA model with fixed effects for treatment, concomitant medication stratum, and country, and with baseline value as a covariate.|Paliperidone Extended Release (ER) - Placebo on the Change Scores.|||-1.1|-4.2|<0.001
72373524|NCT00412373|144258016|SUPERIORITY_OR_OTHER||LS Means Difference|-2.1|STANDARD_ERROR_OF_MEAN|0.6|<|0.001||95.0|-3.3|-0.9|||ANCOVA|P-value is from an ANCOVA model with fixed effects for treatment, concomitant medication stratum, and country, and with baseline value as a covariate.|Paliperidone Extended Release (ER) - Placebo on the Change Scores.|||-0.9|-3.3|<0.001
72373525|NCT00412373|144258017|SUPERIORITY_OR_OTHER||LS Means Difference|-1.9|STANDARD_ERROR_OF_MEAN|0.5|<|0.001||95.0|-2.9|-0.9|||ANCOVA|P-value is from an ANCOVA model with fixed effects for treatment, concomitant medication stratum, and country, and with baseline value as a covariate.|Paliperidone Extended Release (ER) - Placebo on the Change Scores.|||-0.9|-2.9|<0.001
72373526|NCT00412373|144258018|SUPERIORITY_OR_OTHER||LS Means Difference|-1.6|STANDARD_ERROR_OF_MEAN|0.5||0.001||95.0|-2.6|-0.6|||ANCOVA|P-value is from an ANCOVA model with fixed effects for treatment, concomitant medication stratum, and country, and with baseline value as a covariate.|Paliperidone Extended Release (ER) - Placebo on the Change Scores.|||-0.6|-2.6|0.001
72493668|NCT03048422|144516485|SUPERIORITY||Mean Difference (Final Values)|0.057|||<|0.001|TWO_SIDED|95.0|0.036|0.078|||Generalized Estimating Equation|||Null hypothesis of no difference between arms (DTG+FTC/TAF - EFV/FTC/TDF).||0.078|0.036|< 0.001
72373527|NCT00412373|144258019|SUPERIORITY_OR_OTHER||LS Means Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.4||0.016||95.0|-1.8|-0.2|||ANCOVA|P-value is from an ANCOVA model with fixed effects for treatment, concomitant medication stratum, and country, and with baseline value as a covariate.|Paliperidone Extended Release (ER) - Placebo on the Change Scores.|||-0.2|-1.8|0.016
72373528|NCT00412373|144258021|SUPERIORITY_OR_OTHER||LS Means Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.1||0.002||95.0|-0.7|-0.2|||ANCOVA|P-value is from an ANCOVA model with fixed effects for treatment, concomitant medication stratum, and country, and with baseline value as a covariate.|Paliperidone Extended Release (ER) - Placebo on the Change Scores.|||-0.2|-0.7|0.002
72373529|NCT00412373|144258022|SUPERIORITY_OR_OTHER||LS Means Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.2|<|0.001||95.0|-0.9|-0.3|||ANOVA|P-value is from an ANOVA model with fixed effects for treatment, concomitant medication stratum, and country.||||-0.3|-0.9|<0.001
72373530|NCT00412373|144258023|SUPERIORITY_OR_OTHER|||||||0.046||95.0|||||Cochran-Mantel-Haenszel|P-value based on Cochran-Mantel-Haenszel (CMH) chi-square test with modified ridit scores, stratified by concomitant medication stratum, and country.||||||0.046
72373531|NCT00412373|144258025|SUPERIORITY_OR_OTHER||LS Means Difference|-4.1|STANDARD_ERROR_OF_MEAN|1.2|<|0.001||95.0|-6.4|-1.7|||ANCOVA|P-value is from an ANCOVA model with fixed effects for treatment, concomitant medication stratum, and country, and with baseline value as a covariate.|Paliperidone Extended Release (ER) - Placebo on the Change Scores.|||-1.7|-6.4|<0.001
72373532|NCT00412373|144258027|SUPERIORITY_OR_OTHER||LS Means Difference|-4.8|STANDARD_ERROR_OF_MEAN|1.5||0.001||95.0|-7.7|-2.0|||ANCOVA|P-value is from an ANCOVA model with fixed effects for treatment, concomitant medication stratum, and country, and with baseline value as a covariate.|Paliperidone Extended Release (ER) - Placebo on the Change Scores.|||-2.0|-7.7|0.001
72373533|NCT04093024|144258099|OTHER||Adjusted mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.4||0.9858|TWO_SIDED|95.0|-0.8|0.8|||Mixed Model Repeated Measures (MMRM)|Fixed categorical effects: (Randomised) treatment, age-group; Fixed continuous effects: Baseline at each visit, random effect for participant.|Adjusted mean difference was calculated as 'Randomised Nintedanib - randomised placebo'.|No formal hypotheses were tested||0.8|-0.8|0.9858
72373534|NCT04093024|144258100|OTHER||Adjusted mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.8||0.9769|TWO_SIDED|95.0|-1.7|1.6|||Mixed Model Repeated Measures (MMRM)|Fixed categorical effects: (Randomised) treatment, age-group; Fixed continuous effects: Baseline at each visit, random effect for participant.|Adjusted mean difference was calculated as 'Randomised Nintedanib - randomised placebo'.|No formal hypotheses were tested||1.6|-1.7|0.9769
72373535|NCT04093024|144258102|OTHER|No formal hypotheses were tested|Adjusted Mean Difference|1.1|STANDARD_ERROR_OF_MEAN|1.4||0.4442|TWO_SIDED|95.0|-1.8|4.0|||Mixed Model Repeated Measures (MMRM)|Fixed categorical effects: (Randomised) treatment, age-group; Fixed continuous effects: Baseline at each visit, random effect for participant.|Adjusted mean difference was calculated as 'Randomised Nintedanib - randomised placebo'.|||4.0|-1.8|0.4442
72373536|NCT04093024|144258105|OTHER|No formal hypotheses were tested|Adjusted Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.8||0.882|TWO_SIDED|95.0|-1.5|1.8|||Mixed Model Repeated Measures (MMRM)|Fixed categorical effects: (Randomised) treatment, age-group; Fixed continuous effects: Baseline at each visit, random effect for participant.|Adjusted mean difference was calculated as 'Randomised Nintedanib - randomised placebo'.|||1.8|-1.5|0.8820
72373537|NCT04093024|144258106|OTHER||Adjusted mean difference|0.1|STANDARD_ERROR_OF_MEAN|1.6||0.9652|TWO_SIDED|95.0|-3.2|3.3|||Mixed Model Repeated Measures (MMRM)|Fixed categorical effects: (Randomised) treatment, age-group; Fixed continuous effects: Baseline at each visit, random effect for participant.|Adjusted mean difference was calculated as 'Randomised Nintedanib - randomised placebo'.|No formal hypotheses were tested||3.3|-3.2|0.9652
72373538|NCT04093024|144258107|OTHER||Adjusted mean difference|-2.6|STANDARD_ERROR_OF_MEAN|3.1||0.4084|TWO_SIDED|95.0|-9.3|4.0|||Mixed Model Repeated Measures (MMRM)|Fixed categorical effects: (Randomised) treatment, age-group; Fixed continuous effects: Baseline at each visit, random effect for participant.|Adjusted mean difference was calculated as 'Randomised Nintedanib - randomised placebo'.|No formal hypotheses were tested||4.0|-9.3|0.4084
72493669|NCT04647253|144516508|SUPERIORITY||Rate difference between treatment groups|-10.8||||0.0025|TWO_SIDED|95.0|-18.4|-3.3||a priori threshold for statistical significance was 0.025|z-test with unpooled variance|||||-3.3|-18.4|0.0025
72555358|NCT01929863|144642239|SUPERIORITY_OR_OTHER||Ratio|1.036|||||TWO_SIDED|90.0|0.937|1.145|||||The point estimate was calculated as geometric least square mean ratio of Treatment A-GSK2330672 + Metformin and Treatment B-Placebo + Metformin for Cmax.|||1.145|0.937|
72373539|NCT04093024|144258108|OTHER|No formal hypotheses were tested|Adjusted Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.8||0.9928|TWO_SIDED|95.0|-1.6|1.6|||Mixed Model Repeated Measures (MMRM)|Fixed categorical effects: (Randomised) treatment, age-group; Fixed continuous effects: Baseline at each visit, random effect for participant.|Adjusted mean difference was calculated as 'Randomised Nintedanib - randomised placebo'.|||1.6|-1.6|0.9928
72373540|NCT04093024|144258109|OTHER||Adjusted mean difference|0.7|STANDARD_ERROR_OF_MEAN|1.4||0.6366|TWO_SIDED|95.0|-2.3|3.6|||Mixed Model Repeated Measures (MMRM)|Fixed categorical effects: (Randomised) treatment, age-group; Fixed continuous effects: Baseline at each visit, random effect for participant.|Adjusted mean difference was calculated as 'Randomised Nintedanib - randomised placebo'.|No formal hypotheses were tested||3.6|-2.3|0.6366
72373541|NCT04093024|144258110|OTHER||Adjusted mean difference|0.4|STANDARD_ERROR_OF_MEAN|2.3||0.8823|TWO_SIDED|95.0|-5.2|5.9|||Mixed Model Repeated Measures (MMRM)|Fixed categorical effects: (Randomised) treatment, age-group; Fixed continuous effects: Baseline at each visit, random effect for participant.|Adjusted mean difference was calculated as 'Randomised Nintedanib - randomised placebo'.|No formal hypotheses were tested||5.9|-5.2|0.8823
72373542|NCT04093024|144258111|OTHER|No formal hypotheses were tested|Adjusted Mean Difference|1.2052|STANDARD_ERROR_OF_MEAN|2.2491||0.5962|TWO_SIDED|95.0|-3.3966|5.807|||Mixed Model Repeated Measures (MMRM)|Fixed categorical effects: (Randomised) treatment, age-group; Fixed continuous effects: Baseline at each visit, random effect for participant.|Adjusted mean difference was calculated as 'Randomised Nintedanib - randomised placebo'.|||5.8070|-3.3966|0.5962
72373543|NCT04093024|144258112|OTHER|No formal hypotheses were tested|Adjusted Mean Difference|1.7733|STANDARD_ERROR_OF_MEAN|3.1424||0.5776|TWO_SIDED|95.0|-4.7015|8.2481|||Mixed Model Repeated Measures (MMRM)|Fixed categorical effects: (Randomised) treatment, age-group; Fixed continuous effects: Baseline at each visit, random effect for participant.|Adjusted mean difference was calculated as 'Randomised Nintedanib - randomised placebo'.|||8.2481|-4.7015|0.5776
72373544|NCT04093024|144258113|OTHER|No formal hypotheses were tested|Adjusted Mean Difference|-0.134|STANDARD_ERROR_OF_MEAN|4.316||0.9755|TWO_SIDED|95.0|-8.975|8.707|||Mixed Model Repeated Measures (MMRM)|Fixed categorical effects: (Randomised) treatment, age-group; Fixed continuous effects: Baseline at each visit, random effect for participant.|Adjusted mean difference was calculated as 'Randomised Nintedanib - randomised placebo'.|||8.707|-8.975|0.9755
72373545|NCT04093024|144258114|OTHER|No formal hypotheses were tested|Adjusted Mean Difference|3.453|STANDARD_ERROR_OF_MEAN|5.225||0.514|TWO_SIDED|95.0|-7.25|14.157|||Mixed Model Repeated Measures (MMRM)|Fixed categorical effects: (Randomised) treatment, age-group; Fixed continuous effects: Baseline at each visit, random effect for participant.|Adjusted mean difference was calculated as 'Randomised Nintedanib - randomised placebo'.|||14.157|-7.250|0.5140
72432976|NCT03860077|144378828|SUPERIORITY|Average cigarettes per day was positively skewed, with a non-normal residual distribution in a mixed model analysis specifying a normal (Gaussian) outcome distribution. Therefore, this outcome was recoded to integers and modeled as a count with a negative binomial distribution and log link. The focal test is the difference in change from Baseline to Week 4 (i.e., Time) in the VLNC vs. NNC condition (i.e., Group), which is a cross-level interactive effect of Time and Group.|Risk Ratio (RR)|1.42|STANDARD_ERROR_OF_MEAN|0.21||0.111|TWO_SIDED|95.0|0.92|2.19|||Mixed Models Analysis||The reported value is the standard error of the mean for the non-exponentiated estimate = 0.35.|These are results of a 2-group (VLNC \& NNC) x 2 repeated measures (Baseline \& Week 4) mixed effects model to test the effect of the randomization group (VLNC vs. NNC) on change in cigarette use and alternative tobacco product (ATP) use from Baseline to Week 4. Group (VLNC vs. NNC) is a fixed, between-subjects focal predictor. Timepoint (Baseline vs. Week 4) is a fixed, within-subjects repeated measure. Subject is a random effect, accounting for variability in Baseline cigarette and ATP use.||2.19|0.92|.111
72432977|NCT03860077|144378829|SUPERIORITY||Odds Ratio (OR)|0.71|STANDARD_ERROR_OF_MEAN|0.93||0.721|TWO_SIDED|95.0|0.11|4.75|||Mixed Models Analysis||The reported value is the standard error of the mean for the non-exponentiated estimate = - 0.34.|This outcome was recoded as a dichotomous outcome with a binary distribution and log link. The focal test is the difference in change from Baseline to Week 4 (i.e., Time) in the VLNC vs. NNC condition (i.e., Group), which is a cross-level interactive effect of Time and Group.||4.75|.11|.721
72432978|NCT03860077|144378830|SUPERIORITY|Frequencies of non-combustible alternative product use (ATP) were bimodal with peaks at 0 (no use) and 7 (daily use). Therefore, this outcome was recoded as a dichotomous outcome with a binary distribution and log link. The focal test is the difference in change from Baseline to Week 4 (i.e., Time) in the VLNC vs. NNC condition (i.e., Group), which is a cross-level interactive effect of Time and Group.|Odds Ratio (OR)|0.57|STANDARD_ERROR_OF_MEAN|0.96||0.564|TWO_SIDED|95.0|0.08|3.99|||Mixed Models Analysis||The reported value is the standard error of the mean for the non-exponentiated estimate = - 0.56.|||3.99|.08|.564
72432979|NCT03860077|144378831|SUPERIORITY||Slope|0.25|STANDARD_ERROR_OF_MEAN|1.56||0.876|TWO_SIDED|95.0|-2.92|3.42|||Mixed Models Analysis|||The study cigarette outcome is modeled with a normal, Gaussian distribution. The focal test is the difference in change from Baseline to Week 4 (i.e., Time) in the VLNC vs. NNC condition (i.e., Group), which is a cross-level interactive effect of Time and Group. Baseline in this analysis is average number of usual brand cigarettes at baseline, prior to randomization.||3.42|-2.92|.876
72432980|NCT03860077|144378832|SUPERIORITY|The focal test is the difference in change from Baseline to Week 4 (i.e., Time) in the VLNC vs. NNC condition (i.e., Group), which is a cross-level interactive effect of Time and Group.|Slope|-2166.79|STANDARD_ERROR_OF_MEAN|1753.48||0.226|TWO_SIDED|95.0|-5743.04|1409.47|||Mixed Models Analysis|||||1409.47|-5743.04|.226
72432981|NCT00430677|144378950|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.1||||0.746|TWO_SIDED|95.0|0.6|2.03||The median time to confirmed CRR was not estimable due to the low number of events. However, the time to confirmed CRR was compared between the abatacept and placebo treatment regimens using a score test.|Regression, Cox||Point estimate, 95% CI and P-value (based on Score Test) for the hazard ratio is determined by a Cox proportional hazards model including treatment as a covariate and stratified by prior treatment status.|||2.03|0.60|0.746
72432982|NCT00430677|144378950|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.6||||0.118|TWO_SIDED|95.0|0.89|2.83||The median time to confirmed CRR was not estimable due to the low number of events. However, the time to confirmed CRR was compared between the abatacept and placebo treatment regimens using a score test.|Regression, Cox||Point estimate, 95% CI and P-value (based on Score Test) for the hazard ratio is determined by a Cox proportional hazards model including treatment as a covariate and stratified by prior treatment status.|||2.83|0.89|0.118
72432983|NCT00430677|144378953|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.3|||||TWO_SIDED|95.0|0.91|1.78|||||Point Estimate, 95% CI for the hazard ratio was determined by a Cox proportional hazards model including treatment as a covariate and stratified by prior treatment status.|||1.78|0.91|
72432984|NCT00430677|144378953|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.3|||||TWO_SIDED|95.0|0.91|1.77|||||Point Estimate, 95% CI for the hazard ratio was determined by a Cox proportional hazards model including treatment as a covariate and stratified by prior treatment status.|||1.77|0.91|
72432985|NCT00430677|144378959|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.21|||||TWO_SIDED|95.0|0.68|21.3||||||||21.3|0.68|
72373546|NCT04093024|144258115|OTHER|No formal hypotheses were tested|Adjusted Mean Difference|1.03|STANDARD_ERROR_OF_MEAN|3.358||0.7613|TWO_SIDED|95.0|-5.848|7.908|||Mixed Model Repeated Measures (MMRM)|Fixed categorical effects: (Randomised) treatment, age-group; Fixed continuous effects: Baseline at each visit, random effect for participant.|Adjusted mean difference was calculated as 'Randomised Nintedanib - randomised placebo'.|||7.908|-5.848|0.7613
72373547|NCT04093024|144258116|OTHER|No formal hypotheses were tested|Adjusted Mean Difference|0.34|STANDARD_ERROR_OF_MEAN|5.049||0.9468|TWO_SIDED|95.0|-10.026|10.707|||Mixed Model Repeated Measures (MMRM)|Fixed categorical effects: (Randomised) treatment, age-group; Fixed continuous effects: Baseline at each visit, random effect for participant.|Adjusted mean difference was calculated as 'Randomised Nintedanib - randomised placebo'.|||10.707|-10.026|0.9468
72432986|NCT00430677|144378959|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.88|||||TWO_SIDED|95.0|0.49|1.59||||||||1.59|0.49|
72555359|NCT02911701|144642254|SUPERIORITY|||||||0.3|||||||maxim|||||||0.3
72555360|NCT00830024|144642273|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|An analysis of variance (ANOVA) was performed on each of the pharmacokinetic parameters using SAS® software.|Geometric Test/Ref Ratio x 100|98.75||||||90.0|93.35|104.47|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||104.47|93.35|
72432987|NCT00430677|144378961|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.03|||||TWO_SIDED|95.0|-0.13|0.19|||ANCOVA||Adjustment based on ANCOVA model with treatment as factor and randomization strata (prior treatment status) and baseline measurements as covariates.|||0.19|-0.13|
72432988|NCT00430677|144378961|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02|||||TWO_SIDED|95.0|-0.18|0.14|||ANCOVA||Adjustment based on ANCOVA model with treatment as factor and randomization strata (prior treatment status) and baseline measurements as covariates.|||0.14|-0.18|
72432989|NCT00836810|144379001|SUPERIORITY||||||<|0.001||||||A priory test for statistical significance was P\<0.05|t-test, 2 sided|||||||<0.001
72432990|NCT00836810|144379001|SUPERIORITY||||||<|0.001||||||A priori statistical significance set at P\<0.05|t-test, 2 sided|||||||<0.001
72555361|NCT00830024|144642274|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|An analysis of variance (ANOVA) was performed on each of the pharmacokinetic parameters using SAS® software.|Geometric Test/Ref Ratio x 100|95.94||||||90.0|91.76|100.3|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||100.3|91.76|
72432991|NCT00836810|144379001|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.01||||||A priori statistical significance set as P\<0.05|t-test, 2 sided|||||||<0.01
72432992|NCT00836810|144379002|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|A priori statistical significance set at P\<0.05||||||<0.001
72432993|NCT00836810|144379002|SUPERIORITY||||||<|0.01||||||A priori statistical significance set at P\<0.05|t-test, 2 sided|||||||<0.01
72432994|NCT00836810|144379002|SUPERIORITY||||||<|0.01||||||A priori statistical significance set at P\<0.05|t-test, 2 sided|||||||<0.01
72432995|NCT00836810|144379003|SUPERIORITY_OR_OTHER_LEGACY|||||||0.023||||||A priori statistical significance set at P\<0.05|t-test, 2 sided|||||||0.023
72432996|NCT00836810|144379003|SUPERIORITY|||||||0.0906||||||A priori statistical significance set at P\<0.05|t-test, 2 sided|||||||0.0906
72432997|NCT00836810|144379003|SUPERIORITY|||||||0.044||||||A priori statistical significance set at P\<0.05|t-test, 2 sided|||||||0.044
72432998|NCT00836810|144379004|SUPERIORITY|||||||0.007||||||A priori statistical significance set at P\<0.05|t-test, 2 sided|||||||0.007
72432999|NCT00836810|144379004|SUPERIORITY|||||||0.002||||||A priori statistical significance set at P\<0.05|t-test, 2 sided|||||||0.002
72433000|NCT00836810|144379004|SUPERIORITY|||||||0.57||||||A priori statistical significance set at P\<0.05|t-test, 2 sided|||||||0.57
72433001|NCT00836810|144379005|SUPERIORITY|||||||0.022||||||A priori statistical significance set at P\<0.05|t-test, 2 sided|||||||0.022
72433002|NCT00836810|144379005|SUPERIORITY|||||||0.002||||||A priori statistical significance set at P\<0.05|t-test, 2 sided|||||||0.002
72433003|NCT00836810|144379005|SUPERIORITY|||||||0.51||||||A priori statistical significance set at P\<0.05|t-test, 2 sided|||||||0.51
72433004|NCT00836810|144379006|SUPERIORITY|||||||0.003||||||A priori statistical significance set at P\<0.05|t-test, 2 sided|||||||.003
72433005|NCT00836810|144379006|SUPERIORITY|||||||0.001||||||A priori statistical significance set at P\<0.05|t-test, 2 sided|||||||.001
72433006|NCT00836810|144379006|SUPERIORITY|||||||0.88||||||A priori statistical significance set at P\<0.05|t-test, 2 sided|||||||0.88
72433007|NCT00389519|144379075|SUPERIORITY_OR_OTHER|||||||0.044||95.0||||two-sided test|ANCOVA|test from contrast statement from full model||"Planned interim efficacy analysis: 80 placebo and 80 high-dose ramipril subjects provided 93% power, alpha=0.032, to detect 5 mmHg difference in primary outcome. SD of 8.5 mmHg assumed. Alpha of 0.032 required for the planned interim efficacy analysis.~If study continued: 450 total subjects would provide 90% power, alpha=0.027, to detect 3 mmHg difference between placebo and combined ramipril dose groups. Alpha of 0.027 required for the final analysis."||||0.044
72433008|NCT00389519|144379076|SUPERIORITY_OR_OTHER|||||||0.006||95.0||||two-sided, unadjusted|ANCOVA|test from contrast statement from full model||||||0.006
72433009|NCT00946192|144379080|OTHER|Least square means||||||0.039|||||||Mixed Models Analysis|||||||0.039
72433010|NCT00946192|144379081|OTHER|||||||0.018|||||||Mixed Models Analysis|||||||0.018
72433011|NCT04159506|144379125|SUPERIORITY||Median Difference (Final Values)|0.63|||<|0.05|TWO_SIDED|||||This pilot study was designed mostly to determine feasibility and acceptability of TEE, AC, and study methods. Nonetheless, Paired Difference Signed Rank Tests were used to compare conditions given small sample and non-normal distribution of data.|Wilcoxon (Mann-Whitney)|No adjustments were made given this was a pilot study focused on feasibility and acceptability.||||||<0.05
72433012|NCT04159506|144379126|SUPERIORITY||Median Difference (Final Values)|0.31|||<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|No adjustments were made given this was a pilot study focused on feasibility and acceptability.||This pilot study was designed mostly to determine feasibility and acceptability of TEE, AC, and study methods. Nonetheless, Paired Difference Signed Rank Tests were used to compare conditions given small sample and non-normal distribution of data.||||<0.05
72433013|NCT04159506|144379127|SUPERIORITY||Median Difference (Final Values)|0.67|||<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|No adjustments were made given this was a pilot study focused on feasibility and acceptability.||This pilot study was designed mostly to determine feasibility and acceptability of TEE, AC, and study methods. Nonetheless, Paired Difference Signed Rank Tests were used to compare conditions given small sample and non-normal distribution of data.||||<0.05
72433014|NCT02624778|144379134|SUPERIORITY||LS Mean|-0.071|STANDARD_ERROR_OF_MEAN|0.07||0.309|TWO_SIDED|95.0|-0.21|0.07|||Mixed Models Analysis|||||0.07|-0.21|0.309
72433015|NCT02624778|144379134|SUPERIORITY||LS Mean|-0.133|STANDARD_ERROR_OF_MEAN|0.07||0.061|TWO_SIDED|95.0|-0.27|0.01|||Mixed Models Analysis|||||0.01|-0.27|0.061
72433016|NCT02624778|144379134|SUPERIORITY||LS Mean|-0.205|STANDARD_ERROR_OF_MEAN|0.1||0.053|TWO_SIDED|95.0|-0.41|0.0|||Mixed Models Analysis|||||0.00|-0.41|0.053
72433017|NCT02624778|144379134|SUPERIORITY||LS Mean|-0.255|STANDARD_ERROR_OF_MEAN|0.06|<|0.001|TWO_SIDED|95.0|-0.38|-0.13|||Mixed Models Analysis|||||-0.13|-0.38|<0.001
72433018|NCT02624778|144379134|SUPERIORITY||LS Mean|-0.369|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|95.0|-0.51|-0.23|||Mixed Models Analysis|||||-0.23|-0.51|<0.001
72433019|NCT02624778|144379134|SUPERIORITY||LS Mean|-0.329|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|95.0|-0.46|-0.2|||Mixed Models Analysis|||||-0.20|-0.46|<0.001
72493670|NCT01844986|144516509|SUPERIORITY||Hazard Ratio (HR)|0.3|||<|0.0001|TWO_SIDED|95.0|0.23|0.41||Determined using a log-rank test stratified by response to previous platinum chemotherapy|Regression, Cox|Model includes a factor for response to previous platinum chemotherapy|A hazard ratio \< 1 favours olaparib|||0.41|0.23|<0.0001
72373548|NCT04093024|144258117|OTHER|No formal hypotheses were tested|Adjusted Mean Difference|2.31|STANDARD_ERROR_OF_MEAN|1.33||0.0908|TWO_SIDED|95.0|-0.39|5.02|||Mixed Model Repeated Measures (MMRM)|Fixed categorical effects: (Randomised) treatment, age-group; Fixed continuous effects: Baseline at each visit, random effect for participant.|Adjusted mean difference was calculated as 'Randomised Nintedanib - randomised placebo'.|||5.02|-0.39|0.0908
72373549|NCT04093024|144258118|OTHER|No formal hypotheses were tested|Adjusted Mean Difference|2.28|STANDARD_ERROR_OF_MEAN|1.39||0.1222|TWO_SIDED|95.0|-0.69|5.25|||Mixed Model Repeated Measures (MMRM)|Fixed categorical effects: (Randomised) treatment, age-group; Fixed continuous effects: Baseline at each visit, random effect for participant.|Adjusted mean difference was calculated as 'Randomised Nintedanib - randomised placebo'.|||5.25|-0.69|0.1222
72373550|NCT04093024|144258119|OTHER|No formal hypotheses were tested|Adjusted Mean Difference|7.2|STANDARD_ERROR_OF_MEAN|28.2||0.8012|TWO_SIDED|95.0|-50.7|65.0|||Mixed Model Repeated Measures (MMRM)|Fixed categorical effects: (Randomised) treatment, age-group; Fixed continuous effects: Baseline at each visit, random effect for participant.|Adjusted mean difference was calculated as 'Randomised Nintedanib - randomised placebo'.|||65.0|-50.7|0.8012
72373551|NCT04093024|144258120|OTHER|No formal hypotheses were tested|Adjusted Mean Difference|-32.9|STANDARD_ERROR_OF_MEAN|33.8||0.3401|TWO_SIDED|95.0|-103.1|37.2|||Mixed Model Repeated Measures (MMRM)|Fixed categorical effects: (Randomised) treatment, age-group; Fixed continuous effects: Baseline at each visit, random effect for participant.|Adjusted mean difference was calculated as 'Randomised Nintedanib - randomised placebo'.|||37.2|-103.1|0.3401
72373552|NCT00647270|144258129|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.0||||0.074|TWO_SIDED|95.0|-13.3|7.4|||Chi-squared||Treatment difference between adalimumab 80 mg monthly and placebo divided by the difference between adalimumab 40 mg eow and placebo.|Adalimumab 80 mg monthly versus placebo: The null hypothesis associated with this comparison stated that adalimumab 80 mg monthly would be inferior to placebo with respect to ACR20 response percentage; the alternative hypothesis was that adalimumab 80 mg monthly would be superior to placebo with respect to ACR20 response.||7.4|-13.3|0.074
72373553|NCT00647270|144258129|NON_INFERIORITY_OR_EQUIVALENCE|A sensitivity analysis was proposed for the non-inferiority comparison. If the lower confidence limit of θ80 - θ40 was greater than -0.1, then the non-inferiority of adalimumab 80 mg monthly to adalimumab 40 mg eow would be claimed||||||0.74||95.0||||Non - inferiority of adalimumab 80 mg monthly compared with 40 mg eow could not be tested because the null hypothesis of the first comparison was not rejected.|Chi-squared|||The non-inferiority of adalimumab 80 mg monthly to adalimumab 40 mg every other week (eow) was to be claimed if at least 50% of the treatment effect of adalimumab 40 mg eow over placebo was to be achieved by adalimumab 80 mg monthly over placebo.||||0.74
72373554|NCT00647270|144258130|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||ANCOVA|||Using a fixed-sequence multiple-testing approach at an alpha level of 0.05 to test the secondary endpoints, the testing of the null-hypothesis began with the first endpoint and stopped as soon as failure to reject a hypothesis occurred (i.e., P value \> 0.05). Using this procedure, testing stopped after secondary endpoint number 1, change from Baseline in HAQ at Week 12.||||0.002
72373555|NCT00647270|144258131|SUPERIORITY_OR_OTHER|||||||0.005||95.0|||||ANCOVA|||Using a fixed-sequence multiple-testing approach at an alpha level of 0.05 to test the secondary endpoints, the testing of the null-hypothesis began with the first endpoint and stopped as soon as failure to reject a hypothesis occurred (i.e., P value \> 0.05). Using this procedure, testing stopped after secondary endpoint number 1, change from Baseline in HAQ at Week 12.||||0.005
72373556|NCT00647270|144258131|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||ANCOVA|||Using a fixed-sequence multiple-testing approach at an alpha level of 0.05 to test the secondary endpoints, the testing of the null-hypothesis began with the first endpoint and stopped as soon as failure to reject a hypothesis occurred (i.e., P value \> 0.05). Using this procedure, testing stopped after secondary endpoint number 1, change from Baseline in HAQ at Week 12.||||0.002
72373557|NCT00647270|144258132|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||The ANCOVA Model was adjusted for the Baseline Measure.|ANCOVA|||Using a fixed-sequence multiple-testing approach at an alpha level of 0.05 to test the secondary endpoints, the testing of the null-hypothesis began with the first endpoint and stopped as soon as failure to reject a hypothesis occurred (i.e., P value \> 0.05). Using this procedure, testing stopped after secondary endpoint number 1, change from Baseline in HAQ at Week 12.||||0.002
72373558|NCT00647270|144258133|SUPERIORITY_OR_OTHER|||||||0.005||95.0||||The ANCOVA Model was adjusted for Baseline Measure.|ANCOVA|The ANCOVA Model was adjusted for Baseline Measure.||Using a fixed-sequence multiple-testing approach at an alpha level of 0.05 to test the secondary endpoints, the testing of the null-hypothesis began with the first endpoint and stopped as soon as failure to reject a hypothesis occurred (i.e., P value \> 0.05). Using this procedure, testing stopped after secondary endpoint number 1, change from Baseline in HAQ at Week 12.||||0.005
72373559|NCT00796445|144258172|NON_INFERIORITY|The aim of this analysis was to demonstrate the clinical efficacy in terms of disease-free survival (DFS) of recMAGE-A3 + AS15 ASCI compared to placebo in the overall study population of patients with completely resected stage III cutaneous melanoma with macroscopic lymph node involvement.|Hazard Ratio (HR)|1.013||||0.8566|TWO_SIDED|95.0|0.879|1.169|||Regression, Cox|||At Final analysis (Month 30)||1.169|0.879|0.8566
72373560|NCT00796445|144258172|NON_INFERIORITY|The aim of this analysis was to demonstrate the clinical efficacy in terms of DFS of the recMAGE-A3 + AS15 ASCI compared to placebo in the population presenting the potentially favorable gene expression signature.|Hazard Ratio (HR)|1.111||||0.4821|TWO_SIDED|95.0|0.828|1.491|||Regression, Cox|||At Final analysis (Month 30)||1.491|0.828|0.4821
72373561|NCT00796445|144258172|NON_INFERIORITY|The aim of this analysis was to demonstrate the clinical efficacy in terms of DFS of the recMAGE-A3 + AS15 ASCI compared to placebo in the population without the potentially favorable gene expression signature|Hazard Ratio (HR)|0.915||||0.5375|TWO_SIDED|95.0|0.691|1.212|||Regression, Cox|||At Final analysis (Month 30)||1.212|0.691|0.5375
72433020|NCT00531479|144379146|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.74||||0.0434|TWO_SIDED|95.0|-18.99|1.51||P-value based on a 1-sided test and tested against a 1-sided alpha of 0.025 to determine statistical significance.|Z test for difference in proportions||The 95% CI was based on using Greenwood's formula for the variance of the KM estimator.|All-cause mortality calculated using the Kaplan-Meier (KM) product limit estimator on Day 42 (Week 6) within each stratum and weighted by the harmonic mean of the sample sizes in the strata. Treatment difference (stratified) based on a weighted difference in proportions. Stratification variables were site of infection and host factors.||1.51|-18.99|0.0434
72373562|NCT00796445|144258173|NON_INFERIORITY|The aim of this analysis was to demonstrate the clinical efficacy in terms of disease-free survival (DFS) of recMAGE-A3 + AS15 ASCI compared to placebo in the overall study population of patients with completely resected stage III cutaneous melanoma with macroscopic lymph node involvement|Hazard Ratio (HR)|1.023||||0.7534|TWO_SIDED|95.0|0.89|1.175|||Regression, Cox|||At Follow-up analysis (up to Year 5)||1.175|0.890|0.7534
72373563|NCT00796445|144258173|NON_INFERIORITY|The aim of this analysis was to demonstrate the clinical efficacy in terms of DFS of the recMAGE-A3 + AS15 ASCI compared to placebo in the population presenting the potentially favorable gene expression signature.|Hazard Ratio (HR)|1.094||||0.5385|TWO_SIDED|95.0|0.821|1.457|||Regression, Cox|||At Follow-up analysis (up to Year 5)||1.457|0.821|0.5385
72373564|NCT00796445|144258173|NON_INFERIORITY|The aim of this analysis was to demonstrate the clinical efficacy in terms of DFS of the recMAGE-A3 + AS15 ASCI compared to placebo in the population without the potentially favorable gene expression signature.|Hazard Ratio (HR)|0.918||||0.5419|TWO_SIDED|95.0|0.698|1.207|||Regression, Cox|||At Follow-up analysis (up to Year 5)||1.207|0.698|0.5419
72373565|NCT00917644|144258189|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the two treatments was concluded if the 90% confidence intervals for the ratio of adjusted geometric means for both AUCinf and Cmax fell wholly within (80%, 125%)|Ratio of adjusted geometric means|98.79||||||90.0|94.57|103.2|||ANOVA|Values have been back-transformed from the log scale.|Parameter estimate = ratio (%) (test/reference) of adjusted geometric means. AUClast + (Clast\*/kel), where Clast\* was the predicted plasma concentration at the last quantifiable time point estimated from the log-linear regression analysis.|Natural log transformed AUCinf was analyzed using a mixed effects model with sequence, period and treatment as fixed effects and subject within sequence as a random effect. Adjusted mean difference (Test-Ref) and 90% CI was obtained from the model and exponentiated to provide estimates of the ratio of adjusted geometric mean and 90% CI for the ratio. Alternative hypothesis of bioequivalence: (H1: θL \<=µT - µR \<=θU); null hypothesis of inequivalence: (Ho: µT - µR \<θL or µT - µR \>θU).||103.20|94.57|
72373566|NCT00917644|144258191|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the two treatments was concluded if the 90% confidence intervals for the ratio of adjusted geometric means for both AUCinf and Cmax fell wholly within (80%, 125%). AUCinf method of determination includes AUClast calculated value.|Ratio of adjusted geometric means|98.72||||||90.0|94.41|103.23|||ANOVA|Values have been back-transformed from the log scale.|Parameter estimate = ratio (%) (test/reference) of adjusted geometric means. Log-linear trapezoidal method.|Natural log transformed AUClast was analyzed using a mixed effects model with sequence, period and treatment as fixed effects and subject within sequence as a random effect. Estimates of the adjusted mean differences (Test-Reference) and corresponding 90% confidence interval was obtained from the model and exponentiated to provide estimates of the ratio of adjusted geometric mean (Test/Reference) and 90% confidence interval for the ratio.||103.23|94.41|
72373567|NCT00917644|144258192|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the two treatments was concluded if the 90% confidence intervals for the ratio of adjusted geometric means for both AUCinf and Cmax fell wholly within (80%, 125%)|Ratio of adjusted geometric means|104.66||||||90.0|95.73|114.42|||ANOVA|Values have been back-transformed from the log scale.|Parameter estimate = ratio (%) (test/reference) of adjusted geometric means. Observed directly from data.|Natural log transformed Cmax was analyzed using a mixed effects model with sequence, period and treatment as fixed effects and subject within sequence as a random effect. Estimates of the adjusted mean differences (Test-Reference) and corresponding 90% confidence intervals were obtained from the model and exponentiated to provide estimates of the ratio of adjusted geometric mean (Test/Reference) and 90% confidence interval for the ratio.||114.42|95.73|
72373568|NCT00422084|144258198|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The primary efficacy analysis tested the non-inferiority of the PA group compared to the comparator group with regard to the PCR-corrected ACPR response rate at Day 28 using the 2-sided 95% confidence interval (CI) (Newcombe-Wilson score method without continuity correction) and a 5% non-inferiority margin. Non-inferiority was demonstrated if the lower limit of the CI for the difference \>-5%.|ACPR percent difference|0.3||||0.578|TWO_SIDED|95.0|-0.7|1.8||If non-inferiority of PA is demonstrated, the p-value associated with a superiority test was calculated based on a 2-sided Chi-square test. If the calculated p-value is \<5%, then the superiority of PA compared to AL is statistically demonstrated.|Chi-squared|||"Null hypothesis: The PCR-corrected ACPR response rate at Day 28 for the PA group is inferior to the PCR-corrected ACPR response rate at Day 28 for the comparator group (AL) by more than 5%.~Was tested versus the alternative:~Alternative hypothesis: The PCR-corrected ACPR response rate at Day 28 for the PA group is not inferior to the PCR-corrected ACPR response rate at Day 28 for the comparator group (AL) by more than -5%."||1.8|-0.7|0.578
72373569|NCT00759564|144258225|SUPERIORITY_OR_OTHER||Percent Geometric Mean Ratio|124.71|||||TWO_SIDED|90.0|106.57|145.94||||||A one-way ANOVA model with group as a fixed effect was used to compare the natural log transformed Cmax for mild renal impairment group (Test) to normal renal function group (Reference). The adjusted mean differences and 90% confidence intervals (CIs) for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||145.94|106.57|
72373570|NCT00759564|144258225|SUPERIORITY_OR_OTHER||Percent Geometric Mean Ratio|163.51|||||TWO_SIDED|90.0|139.72|191.34||||||A one-way ANOVA model with group as a fixed effect was used to compare the natural log transformed Cmax for moderate renal impairment group (Test) to normal renal function group (Reference). The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||191.34|139.72|
72373571|NCT00759564|144258225|SUPERIORITY_OR_OTHER||Percent Geometric Mean Ratio|58.4|||||TWO_SIDED|90.0|48.16|70.83||||||A one-way ANOVA model with group as a fixed effect was used to compare the natural log transformed Cmax for severe renal impairment group (Test) to normal renal function group (Reference). The adjusted mean differences and 90% confidence intervals (CIs) for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||70.83|48.16|
72433021|NCT00531479|144379147|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.23|||||TWO_SIDED|95.0|-21.6|1.15||P-value for global response was to be reported only if Week 6 mortality was significant.|||95% confidence interval based on the difference in success rates using the normal approximation to the binoial distribution.|Treatment difference (stratified) based on a weighted difference in proportions. Stratification variables: site of infection and host factors.||1.15|-21.6|
72373572|NCT00759564|144258227|SUPERIORITY_OR_OTHER||Percent Geometric Mean Ratio|167.59|||||TWO_SIDED|90.0|137.27|204.61||||||A one-way ANOVA model with group as a fixed effect was used to compare the natural log transformed AUClast for mild renal impairment group (Test) to normal renal function group (Reference). The adjusted mean differences and 90% confidence intervals (CIs) for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||204.61|137.27|
72373573|NCT00759564|144258227|SUPERIORITY_OR_OTHER||Percent Geometric Mean Ratio|246.76|||||TWO_SIDED|90.0|202.11|301.27||||||A one-way ANOVA model with group as a fixed effect was used to compare the natural log transformed AUClast for moderate renal impairment group (Test) to normal renal function group (Reference). The adjusted mean differences and 90% confidence intervals (CIs) for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||301.27|202.11|
72373574|NCT00759564|144258227|SUPERIORITY_OR_OTHER||Percent Geometric Mean Ratio|107.13|||||TWO_SIDED|90.0|88.06|130.32||||||A one-way ANOVA model with group as a fixed effect was used to compare the natural log transformed AUClast for severe renal impairment group (Test) to normal renal function group (Reference). The adjusted mean differences and 90% confidence intervals (CIs) for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||130.32|88.06|
72373575|NCT00759564|144258228|SUPERIORITY_OR_OTHER||Percent Geometric Mean Ratio|168.14|||||TWO_SIDED|90.0|137.4|205.75||||||A one-way ANOVA model with group as a fixed effect was used to compare the natural log transformed AUCinf for mild renal impairment group (Test) to normal renal function group (Reference). The adjusted mean differences and 90% confidence intervals (CIs) for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||205.75|137.40|
72373576|NCT00759564|144258228|SUPERIORITY_OR_OTHER||Percent Geometric Mean Ratio|248.38|||||TWO_SIDED|90.0|202.98|303.94||||||A one-way ANOVA model with group as a fixed effect was used to compare the natural log transformed AUCinf for moderate renal impairment group (Test) to normal renal function group (Reference). The adjusted mean differences and 90% confidence intervals (CIs) for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||303.94|202.98|
72373577|NCT00759564|144258228|SUPERIORITY_OR_OTHER||Percent Geometric Mean Ratio|110.12|||||TWO_SIDED|90.0|89.84|134.98||||||A one-way ANOVA model with group as a fixed effect was used to compare the natural log transformed AUCinf for severe renal impairment group (Test) to normal renal function group (Reference). The adjusted mean differences and 90% confidence intervals (CIs) for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||134.98|89.84|
72373578|NCT00759564|144258230|SUPERIORITY_OR_OTHER||Percent Geometric Mean Ratio|134.86|||||TWO_SIDED|90.0|109.88|165.52||||||A one-way ANOVA model with group as a fixed effect was used to compare the natural log transformed Cmax for mild renal impairment group (Test) to normal renal function group (Reference). The adjusted mean differences and 90% confidence intervals (CIs) for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||165.52|109.88|
72373579|NCT00759564|144258230|SUPERIORITY_OR_OTHER||Percent Geometric Mean Ratio|226.28|||||TWO_SIDED|90.0|184.36|277.72||||||A one-way ANOVA model with group as a fixed effect was used to compare the natural log transformed Cmax for moderate renal impairment group (Test) to normal renal function group (Reference). The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||277.72|184.36|
72373580|NCT00759564|144258230|SUPERIORITY_OR_OTHER||Percent Geometric Mean Ratio|285.05|||||TWO_SIDED|90.0|221.8|366.33||||||A one-way ANOVA model with group as a fixed effect was used to compare the natural log transformed Cmax for severe renal impairment group (Test) to normal renal function group (Reference). The adjusted mean differences and 90% confidence intervals (CIs) for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||366.33|221.80|
72373581|NCT00759564|144258232|SUPERIORITY_OR_OTHER||Percent Geometric Mean Ratio|209.31|||||TWO_SIDED|90.0|158.81|275.87||||||A one-way ANOVA model with group as a fixed effect was used to compare the natural log transformed AUClast for mild renal impairment group (Test) to normal renal function group (Reference). The adjusted mean differences and 90% confidence intervals (CIs) for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||275.87|158.81|
72373582|NCT00759564|144258232|SUPERIORITY_OR_OTHER||Percent Geometric Mean Ratio|353.0|||||TWO_SIDED|90.0|267.83|465.25||||||A one-way ANOVA model with group as a fixed effect was used to compare the natural log transformed AUClast for moderate renal impairment group (Test) to normal renal function group (Reference). The adjusted mean differences and 90% confidence intervals (CIs) for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||465.25|267.83|
72373583|NCT00759564|144258232|SUPERIORITY_OR_OTHER||Percent Geometric Mean Ratio|742.68|||||TWO_SIDED|90.0|529.59|1041.5||||||A one-way ANOVA model with group as a fixed effect was used to compare the natural log transformed AUClast for severe renal impairment group (Test) to normal renal function group (Reference). The adjusted mean differences and 90% confidence intervals (CIs) for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||1041.50|529.59|
72433022|NCT00531479|144379148|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.6||||0.2611|TWO_SIDED|95.0|-10.77|5.56||P-Value based on a 1-sided test and tested against a 1-sided alpha of 0.025 to determine statistical significance.|Z test for difference in proportions||95% confidence interval based on using Greenwood's formula for the variance of the Kaplan Meier estimator.|Treatment difference (stratified) based on a weighted difference in proportions. Stratification variables: site of infection and host factors.||5.56|-10.77|0.2611
72373584|NCT00759564|144258233|SUPERIORITY_OR_OTHER||Percent Geometric Mean Ratio|209.55|||||TWO_SIDED|90.0|158.72|276.66||||||A one-way ANOVA model with group as a fixed effect was used to compare the natural log transformed AUCinf for mild renal impairment group (Test) to normal renal function group (Reference). The adjusted mean differences and 90% confidence intervals (CIs) for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||276.66|158.72|
72373585|NCT00759564|144258233|SUPERIORITY_OR_OTHER||Percent Geometric Mean Ratio|353.26|||||TWO_SIDED|90.0|267.57|466.39||||||A one-way ANOVA model with group as a fixed effect was used to compare the natural log transformed AUCinf for moderate renal impairment group (Test) to normal renal function group (Reference). The adjusted mean differences and 90% confidence intervals (CIs) for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||466.39|267.57|
72373586|NCT00759564|144258233|SUPERIORITY_OR_OTHER||Percent Geometric Mean Ratio|735.77|||||TWO_SIDED|90.0|523.56|1034.0||||||A one-way ANOVA model with group as a fixed effect was used to compare the natural log transformed AUCinf for severe renal impairment group (Test) to normal renal function group (Reference). The adjusted mean differences and 90% confidence intervals (CIs) for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||1034.00|523.56|
72373587|NCT00329849|144258251|NON_INFERIORITY_OR_EQUIVALENCE|The null hypothesis was that for the serogroup A, the seroresponse percentage in the MenACWY-CRM group would be at least 10% lower than that in the MenACWY-PS group at one month postvaccination, i.e. the lower limit of the 95% CI of the difference in response rates (MenACWY-CRM minus MenACWY-PS) ≤-10%.|Group difference|38.0|||||TWO_SIDED|95.0|29.0|47.0|||Chi-squared|||Comparison of hSBA seroresponse for the serogroup A one month after vaccination of MenACWY-CRM and MenACWY-PS||47|29|
72373588|NCT00329849|144258251|NON_INFERIORITY_OR_EQUIVALENCE|The null hypothesis was that for the serogroup C, the seroresponse percentage in the MenACWY-CRM group would be at least 10% lower than that in the MenACWY-PS group at one month postvaccination, i.e. the lower limit of the 95% CI of the difference in response rates (MenACWY-CRM minus MenACWY-PS) ≤-10%.|Group difference|30.0|||||TWO_SIDED|95.0|19.0|40.0|||Chi-squared|||Comparison of hSBA seroresponse for the serogroup C one month after vaccination of MenACWY-CRM and MenACWY-PS||40|19|
72373589|NCT00329849|144258251|NON_INFERIORITY_OR_EQUIVALENCE|The null hypothesis was that for the serogroup W, the seroresponse percentage in the MenACWY-CRM group would be at least 10% lower than that in the MenACWY-PS group at one month postvaccination, i.e. the lower limit of the 95% CI of the difference in response rates (MenACWY-CRM minus MenACWY-PS) ≤-10%.|Group difference|28.0|||||TWO_SIDED|95.0|17.0|39.0|||Chi-squared|||Comparison of hSBA seroresponse for the serogroup W one month after vaccination of MenACWY-CRM and MenACWY-PS||39|17|
72373590|NCT00329849|144258251|NON_INFERIORITY_OR_EQUIVALENCE|The null hypothesis was that for the serogroup Y, the seroresponse percentage in the MenACWY-CRM group would be at least 10% lower than that in the MenACWY-PS group at one month postvaccination, i.e. the lower limit of the 95% CI of the difference in response rates (MenACWY-CRM minus MenACWY-PS) ≤-10%.|Group difference|18.0|||||TWO_SIDED|95.0|8.0|28.0|||Chi-squared|||Comparison of hSBA seroresponse for the serogroup Y one month after vaccination of MenACWY-CRM and MenACWY-PS||28|8|
72373591|NCT00329849|144258252|NON_INFERIORITY_OR_EQUIVALENCE|Safety of MenACWY-CRM vaccination was considered non-inferior to the safety of MenACWY-PS vaccination if the upper limit of the two-sided 95% CI of the ratio (MenACWY-CRM group divided by MenACWY-PS group) of the percentage of subjects experiencing at least one severe systemic reaction during 1 to 7 days after vaccination was less than 3.|Group Ratio|6.37|||||TWO_SIDED|95.0|0.82|49.2|||Risk ratio(MenACWY-CRM/MenACWY-PS)|||||49.2|0.82|
72373592|NCT01782469|144258259|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED|||||Mean percent reduction in ultrasonography assessment score at Vist 2 as compared to Baseline (Visit 1)|Wilcoxon signed-rank test|||||||0.001
72373593|NCT01782469|144258259|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED|||||Mean percent reduction in ultrasonography assessment score at Vist 3 as compared to Baseline (Visit 1)|Wilcoxon signed-rank test|||||||0.001
72373594|NCT01782469|144258259|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Mean percent reduction in ultrasonography assessment score at Vist 4 as compared to Baseline (Visit 1)|Wilcoxon signed-rank test|||||||<0.001
72373595|NCT01782469|144258259|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED|||||Mean percent reduction in ultrasonography assessment score at Vist 5 as compared to Baseline (Visit 1)|Wilcoxon signed-rank test|||||||0.001
72433023|NCT00531479|144379149|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.18||||0.0383|TWO_SIDED|95.0|-21.44|1.09||P-Value based on a 1-sided test and tested against a 1-sided alpha of 0.025 to determine statistical significance.|Z test for difference in proportions||95% confidence intervalbased on using Greenwood's formula for the variance of the Kaplan Meier estimator.|Treatment difference (stratified) based on a weighted difference in proportions. Stratification variables: site of infection and host factors.||1.09|-21.44|0.0383
72433024|NCT00531479|144379150|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.24||||0.1029|TWO_SIDED|95.0|-15.9|3.42||P-Value based on a one-sided test and tested against a 1-sided alpha of 0.025 to determine statistical significance.|Z test for difference in proportions||95% confidence interval based on Greenwood's formula for the variance of the Kaplan Meier estimator.|Treatment difference (stratified) based on a weighted difference in proportions. Stratification variables: site of infection and host factors.||3.42|-15.9|0.1029
72373596|NCT01782469|144258260|SUPERIORITY_OR_OTHER|||||||0.13|TWO_SIDED|||||Mean number of joints with erosions at Vist 2 as compared to Baseline (Visit 1)|Wilcoxon signed-rank test|||||||.130
72373597|NCT01782469|144258260|SUPERIORITY_OR_OTHER|||||||0.031|TWO_SIDED|||||Mean number of joints with erosions at Vist 3 as compared to Baseline (Visit 1)|Wilcoxon signed-rank test|||||||0.031
72373598|NCT01782469|144258260|SUPERIORITY_OR_OTHER|||||||0.006|TWO_SIDED|||||Mean number of joints with erosions at Vist 4 as compared to Baseline (Visit 1)|Wilcoxon signed-rank test|||||||0.006
72373599|NCT01782469|144258260|SUPERIORITY_OR_OTHER|||||||0.003|TWO_SIDED|||||Mean number of joints with erosions at Vist 5 as compared to Baseline (Visit 1)|Wilcoxon signed-rank test|||||||0.003
72373600|NCT01328444|144258274|SUPERIORITY_OR_OTHER||Least squares mean difference|26.5||||0.321|TWO_SIDED|95.0|-25.9|78.9||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least square mean change difference=UMEC 62.5 µg minus Placebo.|||78.9|-25.9|0.321
72373601|NCT01328444|144258274|SUPERIORITY_OR_OTHER||Least squares mean difference|13.1||||0.62|TWO_SIDED|95.0|-38.9|65.1||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least square mean change difference=UMEC 125 µg minus Placebo.|||65.1|-38.9|0.620
72373602|NCT01328444|144258274|SUPERIORITY_OR_OTHER||Least squares mean difference|-10.0||||0.665|TWO_SIDED|95.0|-55.5|35.4||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least square mean change difference=VI 25 µg minus Placebo.|||35.4|-55.5|0.665
72373603|NCT01328444|144258274|SUPERIORITY_OR_OTHER||Least squares mean difference|-4.6||||0.865|TWO_SIDED|95.0|-57.6|48.4||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least square mean change difference=UMEC/VI 62.5/25 µg minus UMEC 62.5 µg.|||48.4|-57.6|0.865
72373604|NCT01328444|144258274|SUPERIORITY_OR_OTHER||Least squares mean difference|31.9||||0.174|TWO_SIDED|95.0|-14.1|77.9||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least square mean change difference=UMEC/VI 62.5/25 µg minus VI 25 µg.|||77.9|-14.1|0.174
72373605|NCT01328444|144258274|SUPERIORITY_OR_OTHER||Least squares mean difference|19.3||||0.472|TWO_SIDED|95.0|-33.4|71.9||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least square mean change difference=UMEC/VI 125/25 µg minus UMEC 125 µg.|||71.9|-33.4|0.472
72373606|NCT01328444|144258274|SUPERIORITY_OR_OTHER||Least squares mean difference|42.4||||0.072|TWO_SIDED|95.0|-3.8|88.7||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least square mean change difference=UMEC/VI 125/25 µg minus VI 25 µg.|||88.7|-3.8|0.072
72373607|NCT01328444|144258274|SUPERIORITY_OR_OTHER||Least squares mean difference|21.9||||0.234|TWO_SIDED|95.0|-14.2|58.0||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least square mean change difference=UMEC/VI 62.5/25 µg minus Placebo.|||58.0|-14.2|0.234
72373608|NCT01328444|144258274|SUPERIORITY_OR_OTHER||Least squares mean difference|32.4||||0.08|TWO_SIDED|95.0|-3.9|68.8||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least square mean change difference=UMEC/VI 125/25 µg minus Placebo.|||68.8|-3.9|0.080
72373609|NCT01328444|144258275|SUPERIORITY_OR_OTHER||Least squares mean difference|0.087||||0.003|TWO_SIDED|95.0|0.03|0.143||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least square mean change difference=UMEC 62.5 µg minus Placebo.|||0.143|0.030|0.003
72373610|NCT01328444|144258275|SUPERIORITY_OR_OTHER||Least squares mean difference|0.14|||<|0.001|TWO_SIDED|95.0|0.084|0.196||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least square mean change difference=UMEC 125 µg minus Placebo.|||0.196|0.084|<0.001
72373611|NCT01328444|144258275|SUPERIORITY_OR_OTHER||Least squares mean difference|0.099|||<|0.001|TWO_SIDED|95.0|0.05|0.148||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least square mean change difference=VI 25 µg minus Placebo.|||0.148|0.050|<0.001
72373612|NCT01328444|144258275|SUPERIORITY_OR_OTHER||Least squares mean difference|0.124|||<|0.001|TWO_SIDED|95.0|0.067|0.181||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least square mean change difference=UMEC/VI 62.5/25 µg minus UMEC 62.5 µg.|||0.181|0.067|<0.001
72433025|NCT00531479|144379151|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.696||||0.083|TWO_SIDED|95.0|0.46|1.04|||Cox proportional hazards model|||Hazard Ratio: hazard of death in the Voriconazole/Anidulafungin arm relative to the Voriconazole/Placebo arm, adjusted for host factor status and site of infection. Participants who died beyond Day 84 were censored.||1.04|0.46|0.083
72433026|NCT00531479|144379152|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.687||||0.164|TWO_SIDED|95.0|0.4|1.16|||Cox proportional hazards model||95% confidence interval based on Greenwood's formula.|Analysis based on Cox proportional hazards model. Participants who died beyond day 84 were censored.||1.16|0.40|0.164
72433027|NCT05642000|144379153|SUPERIORITY||Odds Ratio, log|0.187|STANDARD_ERROR_OF_MEAN|0.136|||TWO_SIDED|95.0|-0.079|0.454|||Mixed Models Analysis|||||0.454|-0.079|
72373613|NCT01328444|144258275|SUPERIORITY_OR_OTHER||Least squares mean difference|0.111|||<|0.001|TWO_SIDED|95.0|0.062|0.161||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least square mean change difference=UMEC/VI 62.5/25 µg minus VI 25 µg.|||0.161|0.062|<0.001
72373614|NCT01328444|144258275|SUPERIORITY_OR_OTHER||Least squares mean difference|0.029||||0.32|TWO_SIDED|95.0|-0.028|0.086||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least square mean change difference=UMEC/VI 125/25 µg minus UMEC 125 µg.|||0.086|-0.028|0.320
72373615|NCT01328444|144258275|SUPERIORITY_OR_OTHER||Least squares mean difference|0.07||||0.007|TWO_SIDED|95.0|0.019|0.12||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least square mean change difference=UMEC/VI 125/25 µg minus VI 25 µg.|||0.120|0.019|0.007
72373616|NCT01328444|144258275|SUPERIORITY_OR_OTHER||Least squares mean difference|0.211|||<|0.001|TWO_SIDED|95.0|0.172|0.249||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least square mean change difference=UMEC/VI 62.5/25 µg minus Placebo.|||0.249|0.172|<0.001
72373617|NCT01328444|144258275|SUPERIORITY_OR_OTHER||Least squares mean difference|0.169|||<|0.001|TWO_SIDED|95.0|0.129|0.209||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least square mean change difference=UMEC/VI 125/25 µg minus Placebo.|||0.209|0.129|<0.001
72373618|NCT00561977|144258295|SUPERIORITY_OR_OTHER|||||||0.14||95.0|||||Mixed Models Analysis|time measurement, treatment group, interaction between time and group term as fixed effect, subject as random effect.||Mean dietary quality score by visit and study group was estimated using SAS PROC MIXED. All analyses were performed using SAS 9.13 (SAS Institute, Cary, NC, USA).||||0.14
72373619|NCT04620798|144258301|SUPERIORITY||Risk Ratio (RR)|1.01|||||TWO_SIDED|95.0|0.96|1.07|||||"This analysis compares the probability of responding Very Often/Always vs. all other response categories. The reference group for this analysis was the control (delayed results) group."|This analysis includes only those participants with a negative antibody test result at baseline to test the association between the treatment condition (immediate vs. delayed test results) and behavioral outcomes. The reference group for this analysis was the control (delayed results) group.||1.07|0.96|
72373620|NCT04620798|144258301|SUPERIORITY||Risk Ratio (RR)|1.05|||||TWO_SIDED|95.0|0.77|1.44|||||"This analysis compares the probability of responding Very Often/Always vs. all other response categories. The reference group for this analysis was the control (delayed results) group."|This analysis uses only those participants with a positive antibody test result at baseline to test the association between the treatment condition (immediate vs. delayed test results) and behavioral outcomes. The reference group for this analysis was the control (delayed results) group.||1.44|0.77|
72373621|NCT04620798|144258302|SUPERIORITY||Risk Ratio (RR)|0.99|||||TWO_SIDED|95.0|0.89|1.1|||||"This analysis compares the probability of responding Very Often/Always vs. all other response categories. The reference group for this analysis was the control (delayed results) group."|This analysis includes only those participants with a negative antibody test result at baseline to test the association between the treatment condition (immediate vs. delayed test results) and behavioral outcomes. The reference group for this analysis was the control (delayed results) group.||1.10|0.89|
72373622|NCT04620798|144258302|SUPERIORITY||Risk Ratio (RR)|0.9|||||TWO_SIDED|95.0|0.5|1.62|||||"This analysis compares the probability of responding Very Often/Always vs. all other response categories. The reference group for this analysis was the control (delayed results) group."|This analysis uses only those participants with a positive antibody test result at baseline to test the association between the treatment condition (immediate vs. delayed test results) and behavioral outcomes. The reference group for this analysis was the control (delayed results) group.||1.62|0.50|
72373623|NCT04620798|144258303|SUPERIORITY||Risk Ratio (RR)|1.01|||||TWO_SIDED|95.0|0.96|1.06|||||"This analysis compares the probability of responding Very Often/Always vs. all other response categories. The reference group for this analysis was the control (delayed results) group."|This analysis includes only those participants with a negative antibody test result at baseline to test the association between the treatment condition (immediate vs. delayed test results) and behavioral outcomes. The reference group for this analysis was the control (delayed results) group.||1.06|0.96|
72373624|NCT04620798|144258303|SUPERIORITY||Risk Ratio (RR)|0.98|||||TWO_SIDED|95.0|0.74|1.31|||||"This analysis compares the probability of responding Very Often/Always vs. all other response categories. The reference group for this analysis was the control (delayed results) group."|This analysis uses only those participants with a positive antibody test result at baseline to test the association between the treatment condition (immediate vs. delayed test results) and behavioral outcomes. The reference group for this analysis was the control (delayed results) group.||1.31|0.74|
72373625|NCT04620798|144258304|SUPERIORITY||Risk Ratio (RR)|0.96|||||TWO_SIDED|95.0|0.84|1.09|||||"This analysis compares the probability of responding Very Often/Always vs. all other response categories. The reference group for this analysis was the control (delayed results) group."|This analysis includes only those participants with a negative antibody test result at baseline to test the association between the treatment condition (immediate vs. delayed test results) and behavioral outcomes. The reference group for this analysis was the control (delayed results) group.||1.09|0.84|
72373626|NCT04620798|144258304|SUPERIORITY||Risk Ratio (RR)|0.75|||||TWO_SIDED|95.0|0.33|1.72|||||"This analysis compares the probability of a response of Very Often/Always vs. all other response categories. The reference group for this analysis was the control (delayed results) group."|This analysis uses only those participants with a positive antibody test result at baseline to test the association between the treatment condition (immediate vs. delayed test results) and behavioral outcomes. The reference group for this analysis was the control (delayed results) group.||1.72|0.33|
72373627|NCT04620798|144258305|SUPERIORITY||Risk Ratio (RR)|0.87|||||TWO_SIDED|95.0|0.74|1.04|||||"This analysis compares the probability of responding Very Often/Always vs. all other response categories. The reference group for this analysis was the control (delayed results) group."|This analysis includes only those participants with a negative antibody test result at baseline to test the association between the treatment condition (immediate vs. delayed test results) and behavioral outcomes. The reference group for this analysis was the control (delayed results) group.||1.04|0.74|
72373628|NCT04620798|144258305|SUPERIORITY||Risk Ratio (RR)|1.4|||||TWO_SIDED|95.0|0.6|3.25|||||"This analysis compares the probability of a response of Very Often/Always vs. all other response categories. The reference group for this analysis was the control (delayed results) group."|This analysis uses only those participants with a positive antibody test result at baseline to test the association between the treatment condition (immediate vs. delayed test results) and behavioral outcomes. The reference group for this analysis was the control (delayed results) group.||3.25|0.60|
72373629|NCT04620798|144258306|SUPERIORITY||Risk Ratio (RR)|1.01|||||TWO_SIDED|95.0|0.99|1.03|||||"This analysis compares the probability of a response of Always vs. all other response categories. The reference group for this analysis was the control (delayed results) group."|This analysis includes only those participants with a negative antibody test result at baseline to test the association between the treatment condition (immediate vs. delayed test results) and behavioral outcomes. The reference group for this analysis was the control (delayed results) group.||1.03|0.99|
72373630|NCT04620798|144258306|SUPERIORITY||Risk Ratio (RR)|0.97|||||TWO_SIDED|95.0|0.77|1.21|||||"This analysis compares the probability of a response of Always vs. all other response categories. The reference group for this analysis was the control (delayed results) group."|This analysis uses only those participants with a positive antibody test result at baseline to test the association between the treatment condition (immediate vs. delayed test results) and behavioral outcomes. The reference group for this analysis was the control (delayed results) group.||1.21|0.77|
72433028|NCT02501629|144379164|SUPERIORITY||Odds Ratio (OR)|1.23||||0.468|TWO_SIDED|95.0|0.702|2.157||Significance at 0.05.|proportional odds model|factors for treatment group and randomization strata (age and OCS dose); baseline OCS dose and duration of OCS use prior to study were covariates.||The proportional odds ratio (reslizumab/placebo) was estimated from this model, representing the ratio of the odds of a patient outcome being in a higher OCS dose reduction category for reslizumab compared to placebo.||2.157|0.702|0.468
72373631|NCT04620798|144258307|SUPERIORITY||Risk Ratio (RR)|1.01|||||TWO_SIDED|95.0|0.97|1.06|||||"This analysis compares the probability of a response of Very Often/Always vs. all other response categories. The reference group for this analysis was the control (delayed results) group."|This analysis includes only those participants with a negative antibody test result at baseline to test the association between the treatment condition (immediate vs. delayed test results) and behavioral outcomes. The reference group for this analysis was the control (delayed results) group.||1.06|0.97|
72373632|NCT04620798|144258307|SUPERIORITY||Risk Ratio (RR)|0.82|||||TWO_SIDED|95.0|0.6|1.11|||||"This analysis compares the probability of a response of Very Often/Always vs. all other response categories. The reference group for this analysis was the control (delayed results) group."|This analysis uses only those participants with a positive antibody test result at baseline to test the association between the treatment condition (immediate vs. delayed test results) and behavioral outcomes. The reference group for this analysis was the control (delayed results) group.||1.11|0.60|
72373633|NCT04620798|144258308|SUPERIORITY||Risk Ratio (RR)|1.0|||||TWO_SIDED|95.0|0.97|1.04|||||"This analysis compares the probability of responding Very Often/Always vs. all other response categories. The reference group for this analysis was the control (delayed results) group."|This analysis includes only those participants with a negative antibody test result at baseline to test the association between the treatment condition (immediate vs. delayed test results) and behavioral outcomes. The reference group for this analysis was the control (delayed results) group.||1.04|0.97|
72373634|NCT04620798|144258308|SUPERIORITY||Risk Ratio (RR)|0.91|||||TWO_SIDED|95.0|0.74|1.12|||||"This analysis compares the probability of a response of Very Often/Always vs. all other response categories. The reference group for this analysis was the control (delayed results) group."|This analysis uses only those participants with a positive antibody test result at baseline to test the association between the treatment condition (immediate vs. delayed test results) and behavioral outcomes. The reference group for this analysis was the control (delayed results) group.||1.12|0.74|
72373635|NCT04620798|144258309|SUPERIORITY||Risk Ratio (RR)|0.94|||||TWO_SIDED|95.0|0.52|1.71|||||This analysis compares the probability of seroconverting during the study period. The reference group for this analysis was the control (delayed results) group.|This analysis includes only those participants with a negative antibody test result at baseline to test the association between the treatment condition (immediate vs. delayed test results) and seroconversion. The reference group for this analysis was the control (delayed results) group.||1.71|0.52|
72373636|NCT04525885|144258318|SUPERIORITY|Comparison based on a longitudinal ANCOVA model that included treatment, visit, treatment-by-visit interaction, gender, log-transformed baseline value, and log-transformed baseline value-by-visit as covariates.|Estimated Relative Reduction (%)|8.7||||0.713|TWO_SIDED|95.0|-30.51|70.03|||ANCOVA||Estimated relative reduction (ERR) relative to placebo was calculated by 100 (e\*\*DIFF -1), where e\*\*DIFF=exponent of difference; and DIFF= treatment difference in change from baseline at Week 24 based on log transformed data.|||70.03|-30.51|0.713
72373637|NCT04525885|144258321|SUPERIORITY||Estimated Relative Reduction (%)|11.58||||0.628|TWO_SIDED|95.0|-28.68|74.57||Comparison based on a longitudinal ANCOVA model that included treatment, visit, treatment-by-visit interaction, gender, log-transformed baseline value, and log-transformed baseline value-by-visit as covariates.|ANCOVA||Estimated relative reduction (ERR) relative to placebo was calculated by 100 (e\*\*DIFF -1), where e\*\*DIFF=exponent of difference; and DIFF= treatment difference in change from baseline at Week 24 based on log transformed data.|||74.57|-28.68|0.628
72373638|NCT04525885|144258322|SUPERIORITY||Odds Ratio (OR)|0.96||||0.917|TWO_SIDED|95.0|0.43|2.13||Comparison based on logistic regression model that included treatment, visit, treatment-by-visit interaction, gender, baseline LCQ total score, and the interaction of baseline LCQ total score by visit as covariates.|Regression, Logistic|||||2.13|0.43|0.917
72373639|NCT04525885|144258323|SUPERIORITY||Odds Ratio (OR)|0.85||||0.687|TWO_SIDED|95.0|0.38|1.88||Comparison based on a logistic regression model that included treatment, visit, treatment-by-visit interaction, gender, baseline 24-hour coughs per hour and the interaction of baseline 24-hour coughs per hour by visit as covariates.|Regression, Logistic|||||1.88|0.38|0.687
72373640|NCT04525885|144258324|OTHER||Odds Ratio (OR)|1.1|||||TWO_SIDED|95.0|0.49|2.49||||||Comparison based on a logistic regression model that included treatment, visit, treatment-by-visit interaction, gender, baseline mean weekly CSD total score and the interaction of baseline mean weekly CSD total score by visit as covariates.||2.49|0.49|
72373641|NCT04525885|144258325|OTHER||Odds Ratio (OR)|1.93|||||TWO_SIDED|95.0|0.8|4.64||||||Comparison based on a logistic regression model that included treatment, visit, treatment-by-visit interaction, gender, baseline mean weekly CSD total score, and the interaction of baseline mean weekly CSD total score by visit as covariates||4.64|0.80|
72433029|NCT02501629|144379165|SUPERIORITY||Odds Ratio (OR)|1.45||||0.234|TWO_SIDED|95.0|0.786|2.683||significance at 0.05.|Regression, Logistic|logistic regression model adjusted for treatment, stratification factors (age group and OCS dose group), duration of OCS use, and baseline value.||As the analysis of the primary efficacy endpoint did not meet criteria for statistical significance (p≤0.05), the secondary efficacy endpoints were not interpreted inferentially according to the pre-defined hierarchy. P-values are nominal, meaning they were obtained from the analysis without adjustments to protect family-wise errors and should be interpreted with caution. Nominal p-values do not indicate treatment differences.||2.683|0.786|0.234
72373642|NCT04525885|144258326|OTHER|Comparison based on a logistic regression model that included treatment, visit, treatment-by-visit interaction, gender, baseline mean weekly VAS score, and the interaction of baseline mean weekly VAS score by visit as covariates.|Odds Ratio (OR)|1.11|||||TWO_SIDED|95.0|0.45|2.72||||||||2.72|0.45|
72373643|NCT00978757|144258338|SUPERIORITY_OR_OTHER|||||||0.05|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||0.05
72373644|NCT02270944|144258352|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|To assess the vaccine formulations equivalence, the lower limit of the two-sided 95% confidence interval (CI) for the ratio of GMCs at Day 31 after vaccination must be \> 0.5 and the upper limit of the two-sided 95% CI must be \< 2.0 (the entire two-sided 95% CI must be contained in the 0.5, 2.0 interval).|Ratio of GMCs|1.02|||||TWO_SIDED|95.0|0.79|1.32|||ANCOVA|Analysis of covariance (ANCOVA) model with vaccine group and center as fixed effects and log10-prevaccination antibody concentration as a covariate||To demonstrate the equivalence of the liquid GBS trivalent vaccine formulation to the lyophilized GBS trivalent vaccine formulation for serotypes Ia when administered to healthy non-pregnant women, as measured by geometric mean concentrations (GMC).||1.32|0.79|
72395051|NCT02700815|144296597|SUPERIORITY||Mean Difference (Net)|1.65|STANDARD_ERROR_OF_MEAN|1.339||0.2193|TWO_SIDED|95.0|-0.98|4.27|||Mixed Models Analysis||The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|A Mixed Model Repeat Measures (MMRM) analysis was used to compare change in PA from baseline between placebo and combination therapy diclofenac + capsaicin. MMRM model included fixed effects of treatment, country, application site (back/neck), time and fixed covariates of baseline PA and baseline PA by time interaction.||4.27|-0.98|0.2193
72395052|NCT02700815|144296597|SUPERIORITY||Mean Difference (Net)|0.28|STANDARD_ERROR_OF_MEAN|0.949||0.7672|TWO_SIDED|95.0|-1.58|2.15|||Mixed Models Analysis||The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|A Mixed Model Repeat Measures (MMRM) analysis was used to compare change in PA from baseline between capsaicin and combination therapy diclofenac + capsaicin. MMRM model included fixed effects of treatment, country, application site (back/neck), time and fixed covariates of baseline PA and baseline PA by time interaction.||2.15|-1.58|0.7672
72373645|NCT02270944|144258353|NON_INFERIORITY|To assess the vaccine formulations equivalence, the lower limit of the two-sided 95% confidence interval (CI) for the ratio of GMCs at Day 31 after vaccination must be \> 0.5 and the upper limit of the two-sided 95% CI must be \< 2.0 (the entire two-sided 95% CI must be contained in the 0.5, 2.0 interval).|Ratio of GMCs|0.99|||||TWO_SIDED|95.0|0.76|1.3|||ANCOVA|Analysis of covariance (ANCOVA) model with vaccine group and center as fixed effects and log10-prevaccination antibody concentration as a covariate||to demonstrate the equivalence of the liquid GBS trivalent vaccine formulation to the lyophilized GBS trivalent vaccine formulation for serotypes III when administered to healthy non-pregnant women, as measured by geometric mean concentrations (GMC).||1.30|0.76|
72373646|NCT02270944|144258354|NON_INFERIORITY|To assess the vaccine formulations equivalence, the lower limit of the two-sided 95% confidence interval (CI) for the ratio of GMCs at Day 31 after vaccination must be \> 0.5 and the upper limit of the two-sided 95% CI must be \< 2.0 (the entire two-sided 95% CI must be contained in the 0.5, 2.0 interval).|Ratio of GMCs|0.94|||||TWO_SIDED|95.0|0.72|1.22|||ANCOVA|Analysis of covariance (ANCOVA) model with vaccine group and center as fixed effects and log10-prevaccination antibody concentration as a covariate||to demonstrate the equivalence of the liquid GBS trivalent vaccine formulation to the lyophilized GBS trivalent vaccine formulation for serotypes Ib when administered to healthy non-pregnant women, as measured by geometric mean concentrations (GMC).||1.22|0.72|
72373647|NCT00095147|144258358|SUPERIORITY_OR_OTHER||adjusted mean change from baseline|-1.04|||<|0.001|TWO_SIDED|95.0|-1.42|-0.67|||ANCOVA|||The primary analysis was the comparison of abatacept versus placebo for changes from baseline to 6 months (Day 197) in the DAS28. This comparison was done using an analysis of covariance (ANCOVA) model with treatment group as the effect and baseline value as the covariate. A 95% confidence interval was computed for the treatment difference within the framework of the ANCOVA model.||-0.67|-1.42|<0.001
72373648|NCT00095147|144258359|SUPERIORITY_OR_OTHER||adjusted mean change from baseline|-0.77|||<|0.001|TWO_SIDED|95.0|-1.14|-0.39|||ANCOVA|||Infliximab versus placebo were compared for changes from baseline to 6 months (Day 197) in the DAS28. This comparison was done using an analysis of covariance (ANCOVA) model with treatment group as the effect and baseline value as the covariate. A 95% confidence interval was computed for the treatment difference within the framework of the ANCOVA model.||-0.39|-1.14|<0.001
72373649|NCT00095147|144258361|SUPERIORITY_OR_OTHER||Estimate of difference from placebo|20.6||||0.001|TWO_SIDED|95.0|7.7|33.6|||Chi-squared, Corrected|||Comparisons were made between ABA and PLA at Day 197 using a continuity corrected Chi-square test. All tests and confidence intervals for treatment comparison were two-sided.||33.6|7.7|0.001
72373650|NCT00095147|144258361|SUPERIORITY_OR_OTHER||Estimate of difference from placebo|17.9||||0.005|TWO_SIDED|95.0|5.1|30.7|||Chi-squared, Corrected|||Comparisons were made between INF and PLA at Day 197 using a continuity corrected Chi-square test. All tests and confidence intervals for treatment comparison were two-sided.||30.7|5.1|0.005
72373651|NCT00095147|144258363|SUPERIORITY_OR_OTHER||Difference from placebo|-0.38|||<|0.001|TWO_SIDED|95.0|-0.53|-0.23|||ANCOVA|||Adjusted mean change in HAQ-DI from baseline to 6 months (Day 197) was compared between ABA and PLA. This comparison was done using an analysis of covariance (ANCOVA) model with treatment group as the effect and baseline value as the covariate. A 95% confidence interval was computed for the treatment difference within the framework of the ANCOVA model.||-0.23|-0.53|<0.001
72373652|NCT00095147|144258363|SUPERIORITY_OR_OTHER||Difference from placebo|-0.3|||<|0.001|TWO_SIDED|95.0|-0.45|-0.15|||ANCOVA|||Adjusted mean change in HAQ-DI from baseline to 6 months (Day 197) was compared between INF and PLA. This comparison was done using an analysis of covariance (ANCOVA) model with treatment group as the effect and baseline value as the covariate. A 95% confidence interval was computed for the treatment difference within the framework of the ANCOVA model.||-0.15|-0.45|<0.001
72373653|NCT00095147|144258365|SUPERIORITY_OR_OTHER||Difference from placebo (PCS)|4.02|||<|0.001|TWO_SIDED|95.0|1.92|6.12|||ANCOVA|||Adjusted mean change in SF-36 physical component summary from baseline to 6 months (Day 197) was compared between ABA and PLA. This comparison was done using an analysis of covariance (ANCOVA) model with treatment group as the effect and baseline value as the covariate. A 95% confidence interval was computed for the treatment difference within the framework of the ANCOVA model.||6.12|1.92|<0.001
72373654|NCT00095147|144258365|SUPERIORITY_OR_OTHER||Difference from placebo (MCS)|3.51||||0.004|TWO_SIDED|95.0|1.1|5.91|||ANCOVA|||Adjusted mean change in SF-36 mental component summary from baseline to 6 months (Day 197) was compared between ABA and PLA. This comparison was done using an analysis of covariance (ANCOVA) model with treatment group as the effect and baseline value as the covariate. A 95% confidence interval was computed for the treatment difference within the framework of the ANCOVA model.||5.91|1.10|0.004
72373655|NCT00095147|144258365|SUPERIORITY_OR_OTHER||Difference from placebo (PCS)|3.32||||0.002|TWO_SIDED|95.0|1.25|5.4|||ANCOVA|||Adjusted mean change in SF-36 physical component summary from baseline to 6 months (Day 197) was compared between INF and PLA. This comparison was done using an analysis of covariance (ANCOVA) model with treatment group as the effect and baseline value as the covariate. A 95% confidence interval was computed for the treatment difference within the framework of the ANCOVA model.||5.40|1.25|0.002
72373656|NCT00095147|144258365|SUPERIORITY_OR_OTHER||Difference from placebo (MCS)|2.68||||0.027|TWO_SIDED|95.0|0.31|5.05|||ANCOVA|||Adjusted mean change in SF-36 mental component summary from baseline to 6 months (Day 197) was compared between INF and PLA. This comparison was done using an analysis of covariance (ANCOVA) model with treatment group as the effect and baseline value as the covariate. A 95% confidence interval was computed for the treatment difference within the framework of the ANCOVA model.||5.05|0.31|0.027
72373657|NCT02390791|144258429|SUPERIORITY|||||||0.04|||||||generalized linear model|assuming a Poisson distribution with a log link function||||||0.04
72373658|NCT02390791|144258430|SUPERIORITY|||||||0.89|||||||Wilcoxon (Mann-Whitney)|||||||0.89
72373659|NCT02390791|144258431|SUPERIORITY|||||||0.85|||||||Wilcoxon (Mann-Whitney)|||||||0.85
72373660|NCT02390791|144258432|SUPERIORITY|||||||0.69|||||||Wilcoxon (Mann-Whitney)|||||||0.69
72373661|NCT02390791|144258433|SUPERIORITY|||||||0.13|||||||Wilcoxon (Mann-Whitney)|||||||0.13
72373662|NCT02390791|144258434|SUPERIORITY|||||||0.94|||||||Wilcoxon (Mann-Whitney)|||||||0.94
72373663|NCT02390791|144258435|SUPERIORITY|||||||0.88|||||||Wilcoxon (Mann-Whitney)|||||||0.88
72373664|NCT02390791|144258436|SUPERIORITY|||||||0.15|||||||Chi-squared|||||||0.15
72373665|NCT02390791|144258437|SUPERIORITY|||||||0.48|||||||generalized linear model|||||||0.48
72373666|NCT02390791|144258438|SUPERIORITY|||||||0.71|||||||generalized linear model|||||||0.71
72373667|NCT01375075|144258439|SUPERIORITY_OR_OTHER||LS Mean Difference|92.61|STANDARD_ERROR_OF_MEAN|9.04|<|0.001|TWO_SIDED|90.0|77.65|107.57||The P-value is for percent change from baseline in HDL-C at Week 2.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||107.57|77.65|<0.001
72373668|NCT01375075|144258439|SUPERIORITY_OR_OTHER||LS Mean Difference|106.17|STANDARD_ERROR_OF_MEAN|10.69|<|0.001|TWO_SIDED|90.0|88.47|123.87||The P-value is for percent change from baseline in HDL-C at Week 4.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||123.87|88.47|<0.001
72373669|NCT01375075|144258439|SUPERIORITY_OR_OTHER||LS Mean Difference|103.66|STANDARD_ERROR_OF_MEAN|11.18|<|0.001|TWO_SIDED|90.0|85.14|122.17||The P-value is for percent change from baseline in HDL-C at Week 8.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||122.17|85.14|<0.001
72373670|NCT01375075|144258439|SUPERIORITY_OR_OTHER||LS Mean Difference|-17.46|STANDARD_ERROR_OF_MEAN|4.39|<|0.001|TWO_SIDED|90.0|-24.73|-10.19||The P-value is for percent change from baseline in LDL-C at Week 2.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||-10.19|-24.73|<0.001
72373671|NCT01375075|144258439|SUPERIORITY_OR_OTHER||LS Mean Difference|-10.39|STANDARD_ERROR_OF_MEAN|4.4||0.019|TWO_SIDED|90.0|-17.67|-3.11||The P-value is for percent change from baseline in LDL-C at Week 4.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||-3.11|-17.67|0.019
72373672|NCT01375075|144258439|SUPERIORITY_OR_OTHER||LS Mean Difference|-12.26|STANDARD_ERROR_OF_MEAN|4.77||0.011|TWO_SIDED|90.0|-20.17|-4.36||The P-value is for percent change from baseline in LDL-C at Week 8.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||-4.36|-20.17|0.011
72373673|NCT01375075|144258442|SUPERIORITY_OR_OTHER||LS Mean Difference|3.74|STANDARD_ERROR_OF_MEAN|2.5||0.136|TWO_SIDED|90.0|-0.39|7.88||The P-value is for change from baseline in SBP at Week 12.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||7.88|-0.39|0.136
72373674|NCT01375075|144258442|SUPERIORITY_OR_OTHER||LS Mean Difference|2.83|STANDARD_ERROR_OF_MEAN|2.48||0.257|TWO_SIDED|90.0|-1.28|6.94||The P-value is for change from baseline in SBP at Week 12.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||6.94|-1.28|0.257
72373675|NCT01375075|144258442|SUPERIORITY_OR_OTHER||LS Mean Difference|5.9|STANDARD_ERROR_OF_MEAN|2.54||0.021|TWO_SIDED|90.0|1.7|10.1||The P-value is for change from baseline in SBP at Week 12.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||10.10|1.70|0.021
72373676|NCT01375075|144258442|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.54|STANDARD_ERROR_OF_MEAN|2.52||0.829|TWO_SIDED|90.0|-4.71|3.62||The P-value is for change from baseline in SBP at Week 12.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||3.62|-4.71|0.829
72433030|NCT02501629|144379166|SUPERIORITY||Odds Ratio (OR)|1.19||||0.596|TWO_SIDED|95.0|0.631|2.229||significance at 0.05.|Regression, Logistic|logistic regression model adjusted for treatment, stratification factors (age group and OCS dose group), duration of OCS use, and baseline value.||As the analysis of the primary efficacy endpoint did not meet criteria for statistical significance (p≤0.05), the secondary efficacy endpoints were not interpreted inferentially according to the pre-defined hierarchy. P-values are nominal, meaning they were obtained from the analysis without adjustments to protect family-wise errors and should be interpreted with caution. Nominal p-values do not indicate treatment differences.||2.229|0.631|0.596
72493671|NCT01844986|144516509|SUPERIORITY||Hazard Ratio (HR)|0.46|||||TWO_SIDED|95.0|0.23|0.97||Not applicable, due to small sample size. China cohort designed to provide descriptive analysis only.|Regression, Cox|Model includes the stratification variable of response to first-line platinum chemotherapy as a covariate.|A hazard ratio \< 1 favours olaparib|||0.97|0.23|
72373677|NCT01375075|144258442|SUPERIORITY_OR_OTHER||LS Mean Difference|0.78|STANDARD_ERROR_OF_MEAN|1.5||0.603|TWO_SIDED|90.0|-1.69|3.24||The P-value is for change from baseline in DBP at Week 12.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||3.24|-1.69|0.603
72373678|NCT01375075|144258442|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.66|STANDARD_ERROR_OF_MEAN|1.48||0.656|TWO_SIDED|90.0|-3.11|1.78||The P-value is for change from baseline in DBP at Week 12.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||1.78|-3.11|0.656
72373679|NCT01375075|144258442|SUPERIORITY_OR_OTHER||LS Mean Difference|1.83|STANDARD_ERROR_OF_MEAN|1.52||0.228|TWO_SIDED|90.0|-0.67|4.34||The P-value is for change from baseline in DBP at Week 12.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||4.34|-0.67|0.228
72373680|NCT01375075|144258442|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.98|STANDARD_ERROR_OF_MEAN|1.51||0.516|TWO_SIDED|90.0|-3.47|1.51||The P-value is for change from baseline in DBP at Week 12.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||1.51|-3.47|0.516
72373681|NCT01375075|144258443|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.73|STANDARD_ERROR_OF_MEAN|1.11||0.513|TWO_SIDED|90.0|-2.57|1.11|||Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||1.11|-2.57|0.513
72373682|NCT01375075|144258443|SUPERIORITY_OR_OTHER||LS Mean Difference|0.04|STANDARD_ERROR_OF_MEAN|1.12||0.97|TWO_SIDED|90.0|-1.82|1.9|||Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||1.90|-1.82|0.970
72373683|NCT01375075|144258443|SUPERIORITY_OR_OTHER||LS Mean Difference|0.26|STANDARD_ERROR_OF_MEAN|1.16||0.824|TWO_SIDED|90.0|-1.66|2.17|||Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||2.17|-1.66|0.824
72373684|NCT01375075|144258443|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.33|STANDARD_ERROR_OF_MEAN|1.12||0.769|TWO_SIDED|90.0|-2.18|1.52|||Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||1.52|-2.18|0.769
72373685|NCT01375075|144258444|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.33||0.735|TWO_SIDED|90.0|-0.65|0.43|||Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||0.43|-0.65|0.735
72373686|NCT01375075|144258444|SUPERIORITY_OR_OTHER||LS Mean Difference|0.22|STANDARD_ERROR_OF_MEAN|0.33||0.503|TWO_SIDED|90.0|-0.32|0.76|||Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||0.76|-0.32|0.503
72373687|NCT01375075|144258444|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.33||0.988|TWO_SIDED|90.0|-0.53|0.54|||Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||0.54|-0.53|0.988
72373688|NCT01375075|144258444|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.41|STANDARD_ERROR_OF_MEAN|0.32||0.207|TWO_SIDED|90.0|-0.95|0.13|||Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||0.13|-0.95|0.207
72373689|NCT01375075|144258445|SUPERIORITY_OR_OTHER||LS Mean Difference|0.13|STANDARD_ERROR_OF_MEAN|0.43||0.756|TWO_SIDED|90.0|-0.57|0.84|||Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||0.84|-0.57|0.756
72373690|NCT01375075|144258445|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.43||0.99|TWO_SIDED|90.0|-0.71|0.7|||Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||0.70|-0.71|0.990
72373691|NCT01375075|144258445|SUPERIORITY_OR_OTHER||LS Mean Difference|0.25|STANDARD_ERROR_OF_MEAN|0.44||0.565|TWO_SIDED|90.0|-0.47|0.97|||Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||0.97|-0.47|0.565
72373692|NCT01375075|144258445|SUPERIORITY_OR_OTHER||LS Mean Difference|0.18|STANDARD_ERROR_OF_MEAN|0.43||0.678|TWO_SIDED|90.0|-0.53|0.89|||Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||0.89|-0.53|0.678
72373693|NCT01375075|144258446|SUPERIORITY_OR_OTHER||LS Mean Difference|0.11|STANDARD_ERROR_OF_MEAN|0.61||0.856|TWO_SIDED|90.0|-0.9|1.12|||Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||1.12|-0.90|0.856
72433031|NCT02501629|144379167|SUPERIORITY||Mean Difference (Final Values)|-17.75|STANDARD_ERROR_OF_MEAN|10.759||0.101|TWO_SIDED|95.0|-38.986|3.494|||mixed model repeated measures (MMRM)||Reslizumab - Placebo|Mixed model repeated measures (MMRM) with fixed effects for treatment, visit, treatment by visit interaction, age group, and OCS dose group, duration of OCS use and baseline value as covariates, and patient as a random effect. Unstructured covariance was assumed for the repeated measures.||3.494|-38.986|0.101
72493672|NCT01844986|144516510|SUPERIORITY||Hazard Ratio (HR)|0.95||||0.8903|TWO_SIDED|95.0|0.6|1.53||Determined using a log-rank test stratified by response to previous platinum chemotherapy|Regression, Cox|Model includes a factor for response to previous platinum chemotherapy|A hazard ratio \< 1 favours olaparib|||1.53|0.60|0.8903
72373694|NCT01375075|144258446|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.61||0.869|TWO_SIDED|90.0|-0.9|1.1|||Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||1.10|-0.90|0.869
72373695|NCT01375075|144258446|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.62||0.869|TWO_SIDED|90.0|-0.92|1.13|||Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||1.13|-0.92|0.869
72373696|NCT01375075|144258446|SUPERIORITY_OR_OTHER||LS Mean Difference|0.61|STANDARD_ERROR_OF_MEAN|0.61||0.317|TWO_SIDED|90.0|-0.4|1.63|||Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||1.63|-0.40|0.317
72373697|NCT01375075|144258448|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.13||0.888|TWO_SIDED|90.0|-0.24|0.2|||ANCOVA|Treatment was included in the model as fixed effects, baseline hsCRP as covariate.||||0.20|-0.24|0.888
72373698|NCT01375075|144258448|SUPERIORITY_OR_OTHER||LS Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.13||0.939|TWO_SIDED|90.0|-0.21|0.23|||ANCOVA|Treatment was included in the model as fixed effects, baseline hsCRP as covariate.||||0.23|-0.21|0.939
72373699|NCT01375075|144258448|SUPERIORITY_OR_OTHER||LS Mean Difference|0.14|STANDARD_ERROR_OF_MEAN|0.13||0.296|TWO_SIDED|90.0|-0.08|0.36|||ANCOVA|Treatment was included in the model as fixed effects, baseline hsCRP as covariate.||||0.36|-0.08|0.296
72373700|NCT01375075|144258448|SUPERIORITY_OR_OTHER||LS Mean Difference|0.18|STANDARD_ERROR_OF_MEAN|0.13||0.181|TWO_SIDED|90.0|-0.04|0.4|||ANCOVA|Treatment was included in the model as fixed effects, baseline hsCRP as covariate.||||0.40|-0.04|0.181
72373701|NCT01375075|144258449|SUPERIORITY_OR_OTHER||LS Mean Difference|-43.29|STANDARD_ERROR_OF_MEAN|5.97|<|0.001|TWO_SIDED|90.0|-53.16|-33.41||The P-value is for percent change from baseline in plasma CETP activity at Week 4.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||-33.41|-53.16|<0.001
72373702|NCT01375075|144258449|SUPERIORITY_OR_OTHER||LS Mean Difference|-76.93|STANDARD_ERROR_OF_MEAN|6.02|<|0.001|TWO_SIDED|90.0|-86.89|-66.97||The P-value is for percent change from baseline in plasma CETP activity at Week 4.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||-66.97|-86.89|<0.001
72373703|NCT01375075|144258449|SUPERIORITY_OR_OTHER||LS Mean Difference|-90.81|STANDARD_ERROR_OF_MEAN|6.08|<|0.001|TWO_SIDED|90.0|-100.87|-80.75||The P-value is for percent change from baseline in plasma CETP activity at Week 4.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||-80.75|-100.87|<0.001
72373704|NCT01375075|144258449|SUPERIORITY_OR_OTHER||LS Mean Difference|-67.25|STANDARD_ERROR_OF_MEAN|5.96|<|0.001|TWO_SIDED|90.0|-77.12|-57.39||The P-value is for percent change from baseline in plasma CETP activity at Week 4.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||-57.39|-77.12|<0.001
72373705|NCT01375075|144258449|SUPERIORITY_OR_OTHER||LS Mean Difference|-42.6|STANDARD_ERROR_OF_MEAN|6.21|<|0.001|TWO_SIDED|90.0|-52.88|-32.33||The P-value is for percent change from baseline in plasma CETP activity at Week 8.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||-32.33|-52.88|<0.001
72373706|NCT01375075|144258449|SUPERIORITY_OR_OTHER||LS Mean Difference|-78.93|STANDARD_ERROR_OF_MEAN|6.17|<|0.001|TWO_SIDED|90.0|-89.15|-68.71||The P-value is for percent change from baseline in plasma CETP activity at Week 8.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||-68.71|-89.15|<0.001
72373707|NCT01375075|144258449|SUPERIORITY_OR_OTHER||LS Mean Difference|-93.67|STANDARD_ERROR_OF_MEAN|6.29|<|0.001|TWO_SIDED|90.0|-104.08|-83.26||The P-value is for percent change from baseline in plasma CETP activity at Week 8.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||-83.26|-104.08|<0.001
72373708|NCT01375075|144258449|SUPERIORITY_OR_OTHER||LS Mean Difference|-75.01|STANDARD_ERROR_OF_MEAN|6.31|<|0.001|TWO_SIDED|90.0|-85.46|-64.57||The P-value is for percent change from baseline in plasma CETP activity at Week 8.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||-64.57|-85.46|<0.001
72373709|NCT01375075|144258449|SUPERIORITY_OR_OTHER||LS Mean Difference|-50.28|STANDARD_ERROR_OF_MEAN|4.98|<|0.001|TWO_SIDED|90.0|-58.53|-42.04||The P-value is for percent change from baseline in plasma CETP activity at Week 12.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||-42.04|-58.53|<0.001
72373710|NCT01375075|144258449|SUPERIORITY_OR_OTHER||LS Mean Difference|-83.07|STANDARD_ERROR_OF_MEAN|4.98|<|0.001|TWO_SIDED|90.0|-91.32|-74.83||The P-value is for percent change from baseline in plasma CETP activity at Week 12.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||-74.83|-91.32|<0.001
72373711|NCT01375075|144258449|SUPERIORITY_OR_OTHER||LS Mean Difference|-94.51|STANDARD_ERROR_OF_MEAN|5.08|<|0.001|TWO_SIDED|90.0|-102.92|-86.1||The P-value is for percent change from baseline in plasma CETP activity at Week 12.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||-86.10|-102.92|<0.001
72373712|NCT01375075|144258449|SUPERIORITY_OR_OTHER||LS Mean Difference|-67.68|STANDARD_ERROR_OF_MEAN|5.15|<|0.001|TWO_SIDED|90.0|-76.2|-59.16||The P-value is for percent change from baseline in plasma CETP activity at Week 12.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||-59.16|-76.20|<0.001
72433032|NCT02501629|144379168|SUPERIORITY||Odds Ratio (OR)|1.36||||0.341|TWO_SIDED|95.0|0.722|2.562||significance at 0.05.|Regression, Logistic|logistic regression model adjusted for treatment, stratification factors (age group and OCS dose group), duration of OCS use, and baseline value.||As the analysis of the primary efficacy endpoint did not meet criteria for statistical significance (p≤0.05), the secondary efficacy endpoints were not interpreted inferentially according to the pre-defined hierarchy. P-values are nominal, meaning they were obtained from the analysis without adjustments to protect family-wise errors and should be interpreted with caution. Nominal p-values do not indicate treatment differences.||2.562|0.722|0.341
72433033|NCT02501629|144379169|SUPERIORITY||CAE rate ratio|0.82||||0.407|TWO_SIDED|95.0|0.504|1.321|||Negative binomial regression model|Negative binomial regression model adjusted for stratification factors (OCS dose group), age, number of prior exacerbations, and an offset variable.|reslizumab vs placebo|||1.321|0.504|0.407
72433034|NCT02501629|144379170|SUPERIORITY||Odds Ratio (OR)|0.82||||0.628|TWO_SIDED|95.0|0.371|1.818||significance at 0.05.|Regression, Logistic|logistic regression model adjusted for treatment, stratification factors (age group and OCS dose group), duration of OCS use, and baseline value.||As the analysis of the primary efficacy endpoint did not meet criteria for statistical significance (p≤0.05), the secondary efficacy endpoints were not interpreted inferentially according to the pre-defined hierarchy. P-values are nominal, meaning they were obtained from the analysis without adjustments to protect family-wise errors and should be interpreted with caution. Nominal p-values do not indicate treatment differences.||1.818|0.371|0.628
72373713|NCT01375075|144258450|SUPERIORITY_OR_OTHER||LS Mean Difference|1.8|STANDARD_ERROR_OF_MEAN|0.25|<|0.001|TWO_SIDED|90.0|1.38|2.21||The P-value is for change from baseline in plasma CETP mass at Week 4.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||2.21|1.38|<0.001
72373714|NCT01375075|144258450|SUPERIORITY_OR_OTHER||LS Mean Difference|3.06|STANDARD_ERROR_OF_MEAN|0.25|<|0.001|TWO_SIDED|90.0|2.65|3.48||The P-value is for change from baseline in plasma CETP mass at Week 4.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||3.48|2.65|<0.001
72373715|NCT01375075|144258450|SUPERIORITY_OR_OTHER||LS Mean Difference|3.46|STANDARD_ERROR_OF_MEAN|0.25|<|0.001|TWO_SIDED|90.0|3.04|3.88||The P-value is for change from baseline in plasma CETP mass at Week 4.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||3.88|3.04|<0.001
72373716|NCT01375075|144258450|SUPERIORITY_OR_OTHER||LS Mean Difference|2.22|STANDARD_ERROR_OF_MEAN|0.25|<|0.001|TWO_SIDED|90.0|1.81|2.63||The P-value is for change from baseline in plasma CETP mass at Week 4.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||2.63|1.81|<0.001
72373717|NCT01375075|144258450|SUPERIORITY_OR_OTHER||LS Mean Difference|1.88|STANDARD_ERROR_OF_MEAN|0.29|<|0.001|TWO_SIDED|90.0|1.4|2.36||The P-value is for change from baseline in plasma CETP mass at Week 8.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||2.36|1.40|<0.001
72373718|NCT01375075|144258450|SUPERIORITY_OR_OTHER||LS Mean Difference|2.99|STANDARD_ERROR_OF_MEAN|0.29|<|0.001|TWO_SIDED|90.0|2.51|3.47||The P-value is for change from baseline in plasma CETP mass at Week 8.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||3.47|2.51|<0.001
72373719|NCT01375075|144258450|SUPERIORITY_OR_OTHER||LS Mean Difference|3.92|STANDARD_ERROR_OF_MEAN|0.3|<|0.001|TWO_SIDED|90.0|3.42|4.41||The P-value is for change from baseline in plasma CETP mass at Week 8.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||4.41|3.42|<0.001
72373720|NCT01375075|144258450|SUPERIORITY_OR_OTHER||LS Mean Difference|2.04|STANDARD_ERROR_OF_MEAN|0.29|<|0.001|TWO_SIDED|90.0|1.56|2.52||The P-value is for change from baseline in plasma CETP mass at Week 8.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||2.52|1.56|<0.001
72373721|NCT01375075|144258450|SUPERIORITY_OR_OTHER||LS Mean Difference|1.82|STANDARD_ERROR_OF_MEAN|0.29|<|0.001|TWO_SIDED|90.0|1.34|2.31||The P-value is for change from baseline in plasma CETP mass at Week 12.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||2.31|1.34|<0.001
72373722|NCT01375075|144258450|SUPERIORITY_OR_OTHER||LS Mean Difference|2.83|STANDARD_ERROR_OF_MEAN|0.29|<|0.001|TWO_SIDED|90.0|2.34|3.31||The P-value is for change from baseline in plasma CETP mass at Week 12.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||3.31|2.34|<0.001
72373723|NCT01375075|144258450|SUPERIORITY_OR_OTHER||LS Mean Difference|3.24|STANDARD_ERROR_OF_MEAN|0.3|<|0.001|TWO_SIDED|90.0|2.74|3.73||The P-value is for change from baseline in plasma CETP mass at Week 12.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||3.73|2.74|<0.001
72373724|NCT01375075|144258450|SUPERIORITY_OR_OTHER||LS Mean Difference|2.14|STANDARD_ERROR_OF_MEAN|0.29|<|0.001|TWO_SIDED|90.0|1.65|2.63||The P-value is for change from baseline in plasma CETP mass at Week 12.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||2.63|1.65|<0.001
72373725|NCT01375075|144258451|SUPERIORITY_OR_OTHER||LS Mean Difference|74.23|STANDARD_ERROR_OF_MEAN|12.59|<|0.001|TWO_SIDED|90.0|53.38|95.07||The P-value is for percent change from baseline in HDL-C at Week 12.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||Comparisons between LY2484595 and Placebo were the primary focus for this endpoint.||95.07|53.38|<0.001
72373726|NCT01375075|144258451|SUPERIORITY_OR_OTHER||LS Mean Difference|115.36|STANDARD_ERROR_OF_MEAN|12.55|<|0.001|TWO_SIDED|90.0|94.58|136.14||The P-value is for percent change from baseline in HDL-C at Week 12.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||Comparisons between LY2484595 and Placebo were the primary focus for this endpoint.||136.14|94.58|<0.001
72433035|NCT02004613|144379173|SUPERIORITY||Risk Ratio (RR)|0.91||||0.34|TWO_SIDED|97.8|0.72|1.15|||Regression, Logistic|||Hypothesis: dexmedetomidine would reduce the incidence of postoperative atrial arrhythmias.||1.15|0.72|0.34
72373727|NCT01375075|144258451|SUPERIORITY_OR_OTHER||LS Mean Difference|135.57|STANDARD_ERROR_OF_MEAN|12.72|<|0.001|TWO_SIDED|90.0|114.5|156.63||The P-value is for percent change from baseline in HDL-C at Week 12.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||Comparisons between LY2484595 and Placebo were the primary focus for this endpoint.||156.63|114.50|<0.001
72373728|NCT01375075|144258451|SUPERIORITY_OR_OTHER||LS Mean Difference|-15.47|STANDARD_ERROR_OF_MEAN|4.85||0.002|TWO_SIDED|90.0|-23.5|-7.43||The P-value is for percent change from baseline in LDL-C at Week 12.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||Comparisons between LY2484595 and Placebo were the primary focus for this endpoint.||-7.43|-23.50|0.002
72373729|NCT01375075|144258451|SUPERIORITY_OR_OTHER||LS Mean Difference|-23.37|STANDARD_ERROR_OF_MEAN|4.83|<|0.001|TWO_SIDED|90.0|-31.37|-15.38||The P-value is for percent change from baseline in LDL-C at Week 12.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||Comparisons between LY2484595 and Placebo were the primary focus for this endpoint.||-15.38|-31.37|<0.001
72373730|NCT01375075|144258451|SUPERIORITY_OR_OTHER||LS Mean Difference|-22.19|STANDARD_ERROR_OF_MEAN|4.91|<|0.001|TWO_SIDED|90.0|-30.32|-14.06||The P-value is for percent change from baseline in LDL-C at Week 12.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||Comparisons between LY2484595 and Placebo were the primary focus for this endpoint.||-14.06|-30.32|<0.001
72373731|NCT01375075|144258451|SUPERIORITY_OR_OTHER||LS Mean Difference|103.25|STANDARD_ERROR_OF_MEAN|12.64|<|0.001|TWO_SIDED|90.0|82.32|124.18||The P-value is for percent change from baseline in HDL-C at Week 12.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||124.18|82.32|<0.001
72373732|NCT01375075|144258451|SUPERIORITY_OR_OTHER||LS Mean Difference|-14.63|STANDARD_ERROR_OF_MEAN|4.88||0.003|TWO_SIDED|90.0|-22.72|-6.55||The P-value is for percent change from baseline in LDL-C at Week 12.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||-6.55|-22.72|0.003
72373733|NCT03137069|144258466|SUPERIORITY||Least Squares Mean Difference|-7.02||||0.0559|TWO_SIDED|90.0|-13.01|-1.03|||Mixed Models Analysis|Covariates included were region, treatment group, visit, and visit by treatment group interaction||||-1.03|-13.01|0.0559
72373734|NCT03137069|144258466|SUPERIORITY||Least Squares Mean Difference|-0.51||||0.8892|TWO_SIDED|90.0|-6.6|5.58|||Mixed Models Analysis|Covariates included were region, treatment group, visit, and visit by treatment group interaction||||5.58|-6.60|0.8892
72433036|NCT02004613|144379174|SUPERIORITY||Risk Ratio (RR)|1.48||||0.026|TWO_SIDED|97.8|0.99|2.23|||Regression, Logistic|||hypothesis: Dexmedetomidine may reduce the incidence of postoperative delirium.||2.23|0.99|0.026
72373735|NCT03137069|144258466|SUPERIORITY||Least Squares Mean Difference|-6.43||||0.0717|TWO_SIDED|90.0|-12.29|-0.57|||Mixed Models Analysis|Covariates included were region, treatment group, visit, and visit by treatment group interaction||||-0.57|-12.29|0.0717
72373736|NCT03137069|144258466|SUPERIORITY||Least Squares Mean Difference|-9.53||||0.0097|TWO_SIDED|90.0|-15.5|-3.55|||Mixed Models Analysis|Covariates included were region, treatment group, visit, and visit by treatment group interaction||||-3.55|-15.50|0.0097
72373737|NCT03137069|144258467|SUPERIORITY|||||||0.1087|||||||Cochran-Mantel-Haenszel|Stratified by region||||||0.1087
72373738|NCT03137069|144258467|SUPERIORITY|||||||0.3418|||||||Cochran-Mantel-Haenszel|Stratified by region||||||0.3418
72373739|NCT03137069|144258467|SUPERIORITY|||||||0.0459|||||||Cochran-Mantel-Haenszel|Stratified by region||||||0.0459
72373740|NCT03137069|144258467|SUPERIORITY|||||||0.019|||||||Cochran-Mantel-Haenszel|Stratified by region||||||0.0190
72373741|NCT03137069|144258468|SUPERIORITY||Least Squares Mean Difference|-12.88||||0.001|TWO_SIDED|90.0|-18.94|-6.82|||Mixed Models Analysis|Covariates included were region, treatment group, visit, and visit by treatment group interaction||||-6.82|-18.94|0.0010
72373742|NCT03137069|144258468|SUPERIORITY||Least Squares Mean Difference|-2.83||||0.4565|TWO_SIDED|90.0|-9.11|3.46|||Mixed Models Analysis|Covariates included were region, treatment group, visit, and visit by treatment group interaction||||3.46|-9.11|0.4565
72373743|NCT03137069|144258468|SUPERIORITY||Least Squares Mean Difference|-5.03||||0.1711|TWO_SIDED|90.0|-11.1|1.03|||Mixed Models Analysis|Covariates included were region, treatment group, visit, and visit by treatment group interaction||||1.03|-11.10|0.1711
72373744|NCT03137069|144258468|SUPERIORITY||Least Squares Mean Difference|-10.76||||0.005|TWO_SIDED|90.0|-16.97|-4.56|||Mixed Models Analysis|Covariates included were region, treatment group, visit, and visit by treatment group interaction||||-4.56|-16.97|0.0050
72373745|NCT02043899|144258480|OTHER|"1. Exact one-sided binomial test of the null hypothesis (p≤90%) using α=0.05 on \[124I\]mIBG PET/CT SIOPEN consensus scores. If this was accepted and the alternative hypothesis rejected, then trial stopped early for futility.~2. If the null hypothesis was rejected, then a one-sided binomial test of the null hypothesis (p≥97%) was performed (α=0.025). If this was accepted and the alternative hypothesis rejected then the trial stopped early for efficacy."|||||<|0.001||||||Overall design has 82% power and an α of 0.03. Total minimum sample size of 100 lesions was calculated based on a single stage A'hern design with p0 = 0.90 and p1 = 0.97. The overall power and α was calculated based on exact binomial probabilities.|Exact one-sided binomial test||||"For the primary endpoint, a sensitivity analysis was also performed on patients with \<20 positive lesions on \[124I\]mIBG PET/CT to test if few patients with large numbers of positive lesions were affecting the results. The results of the sensitivity analysis were consistent with those of the overall analysis.~Secondary efficacy analysis, separate exact one-sided binomial test of the null hypothesis (p≥97%), performed (α=0.025) performed for skeletal and soft tissue lesions."|||<0.001
72373746|NCT02720107|144258483|SUPERIORITY_OR_OTHER||||||<|0.0001||||||The ANCOVA model included the covariates center, baseline of corresponding cell counts from Core study, sex and duration of disease until start of Core study|ANCOVA|||CD4+ Naïve T cells||||< 0.0001
72373747|NCT02720107|144258483|SUPERIORITY_OR_OTHER|||||||0.0493||||||The ANCOVA model included the covariates center, baseline of corresponding cell counts from study Core study, sex and duration of disease until start of Core study|ANCOVA|||CD4+ Central memory T cells||||0.0493
72373748|NCT02720107|144258483|SUPERIORITY_OR_OTHER||||||<|0.0001||||||The ANCOVA model included the covariates center, baseline of corresponding cell counts from Core study, sex and duration of disease until start of Core study|ANCOVA|||CD4+ Effector memory T cells||||< 0.0001
72373749|NCT02720107|144258483|SUPERIORITY_OR_OTHER||||||<|0.0001||||||The ANCOVA model included the covariates center, baseline of corresponding cell counts from Core study, sex and duration of disease until start of Core study|ANCOVA|||CD8+ Naïve T cells||||< 0.0001
72373750|NCT02720107|144258483|SUPERIORITY_OR_OTHER||||||<|0.0001||||||The ANCOVA model included the covariates center, baseline of corresponding cell counts from Core study, sex and duration of disease until start of Core study|ANCOVA|||CD8+ Central memory T cells||||< 0.0001
72373751|NCT02720107|144258483|SUPERIORITY_OR_OTHER||||||<|0.0001||||||The ANCOVA model included the covariates center, baseline of corresponding cell counts from Core study, sex and duration of disease until start of Core study|ANCOVA|||CD8+ Effector memory T cells||||< 0.0001
72373752|NCT02720107|144258483|SUPERIORITY_OR_OTHER||||||<|0.0001||||||The ANCOVA model included the covariates center, baseline of corresponding cell counts from Core study, sex and duration of disease until start of Core study|ANCOVA|||TH17 central memory cells||||< 0.0001
72373753|NCT03930264|144258494|EQUIVALENCE|For bioequivalence, the 90% CIs of the geometric mean ratio of Cmax for tablet and suspension were required to be within the 80 to 125% range.|Odds Ratio (OR)|1.12||||0.3008|TWO_SIDED|90.0|0.93|1.35|||ANOVA|||||1.35|0.93|0.3008
72433037|NCT02004613|144379175|SUPERIORITY||Risk Ratio (RR)|1.4||||0.14|TWO_SIDED|97.5|0.84|2.34|||Regression, Logistic|||||2.34|0.84|0.14
72373754|NCT03930264|144258495|EQUIVALENCE|For bioequivalence, the 90% CIs of the geometric mean ratio of AUC0-τ for tablet and suspension were required to be within the 80 to 125% range.|Ratio|1.06||||0.1061|TWO_SIDED|90.0|1.0|1.13|||ANOVA|||||1.13|1.00|0.1061
72373755|NCT03930264|144258496|EQUIVALENCE|For bioequivalence, the 90% CIs of the geometric mean ratio of AUC0-∞ for tablet and suspension were required to be within the 80 to 125% range.|Ratio|1.02||||0.5696|TWO_SIDED|90.0|0.96|1.09|||ANOVA|||||1.09|0.96|0.5696
72373756|NCT02434471|144258497|OTHER||Mean Difference (Final Values)|0.6|||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
72373757|NCT02434471|144258498|OTHER||Mean Difference (Final Values)|0.1||||0.83|TWO_SIDED||||||Mixed Models Analysis|||||||0.83
72373758|NCT01347580|144258506|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.03||||0.8214|TWO_SIDED|95.0|0.799|1.327||pvalue at 0.025 , adjusted for multiple comparisons|Regression, Logistic|||||1.327|0.799|0.8214
72373759|NCT01347580|144258507|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.074||||0.6322|TWO_SIDED|95.0|0.801|1.441||P value at 0.025 adjusted for multiple comparisons|Regression, Logistic|||||1.441|0.801|0.6322
72373760|NCT01347580|144258508|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.027||||0.9056|TWO_SIDED|95.0|0.661|1.595|||Regression, Logistic|||||1.595|0.661|0.9056
72433038|NCT02004613|144379176|OTHER||Risk Ratio (RR)|0.87||||0.29|TWO_SIDED|97.5|0.65|1.16|||Regression, Logistic|||||1.16|0.65|0.29
72433039|NCT00530335|144379205|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value comparing difference in Total ADHD Symptoms Score (endpoint - baseline).|t-test, 2 sided|||||||<0.001
72373761|NCT01347580|144258509|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.215||||0.4168|TWO_SIDED|95.0|0.76|1.942|||Regression, Logistic|||||1.942|0.760|0.4168
72373762|NCT01347580|144258510|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.189||||0.0307|TWO_SIDED|95.0|0.042|0.856|||Regression, Logistic|||||0.856|0.042|0.0307
72373763|NCT01347580|144258511|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.132||||0.344|TWO_SIDED|95.0|0.876|1.462|||Regression, Logistic|||||1.462|0.876|0.344
72373764|NCT01347580|144258512|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.225||||0.0547|TWO_SIDED|95.0|0.996|1.506|||Regression, Logistic|||||1.506|0.996|0.0547
72373765|NCT01347580|144258513|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.803||||0.166|TWO_SIDED|95.0|0.588|1.096|||Regression, Logistic|||||1.096|0.588|0.1660
72373766|NCT01250496|144258518|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.45||||0.04|TWO_SIDED|95.0|0.2|0.98||No adjustment for multiple comparisons was performed. The threshold for statistical significance was \< 0.05|Chi-squared|||null hypothesis: aminophylline administration does not reduce the incidence of the primary endpoint as compared to placebo. The chi-square test was used to compare event rate between the study arm.||0.98|0.2|0.04
72373767|NCT01250496|144258519|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.39|||<|0.001|TWO_SIDED|95.0|0.2|0.7||P value is not adjusted for multiple comparisons.|Chi-squared|||"null hypothesis: the rate of regadenoson adverse effects (global symptomatic burden) in the aminophylline and placebo group are not statistically different.~The chi-square test was used for comparison."||0.7|0.2|< 0.001
72373768|NCT01425463|144258520|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority of the investigational drug (Ferrous (II) Glycine Sulphate Complex) to the reference drug (Polyferose) was concluded if the lower limit of the two-sided 95 % confidence interval was greater than -7.0 g/L.|LS-Mean of ANCOVA|-2.19|||||TWO_SIDED|95.0|-8.47|4.09||||||||4.09|-8.47|
72433040|NCT00530335|144379205|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value comparing difference in Inattentive Subscale scores (endpoint - baseline).|t-test, 2 sided|||||||<0.001
72373769|NCT02871882|144258535|SUPERIORITY||||||<|0.05|||||||ANCOVA|||||||<0.05
72373770|NCT00797966|144258567|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.53||||0.6551|TWO_SIDED|95.0|-2.87|1.81|||ANCOVA|||The planned sample size of 120 participants per arm will yield 80% power to detect the treatment effects at a 2-tailed significance level of 0.025. The 0.025 significance level corresponds to the second level of Hochberg's procedure for handling the two primary efficacy comparisons.||1.81|-2.87|0.6551
72373771|NCT00797966|144258567|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.37||||0.7037|TWO_SIDED|95.0|-2.3|1.55|||ANCOVA|||The planned sample size of 120 participants per arm will yield 80% power to detect the treatment effects at a 2-tailed significance level of 0.025. The 0.025 significance level corresponds to the second level of Hochberg's procedure for handling the two primary efficacy comparisons.||1.55|-2.30|0.7037
72373772|NCT00797966|144258567|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.14||||0.0303|TWO_SIDED|95.0|-4.08|-0.21|||ANCOVA|||The planned sample size of 120 participants per arm will yield 80% power to detect the treatment effects at a 2-tailed significance level of 0.025. The 0.025 significance level corresponds to the second level of Hochberg's procedure for handling the two primary efficacy comparisons.||-0.21|-4.08|0.0303
72373773|NCT00797966|144258568|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.13||||0.4166|TWO_SIDED|95.0|-0.43|0.18|||ANCOVA||Treatment difference = difference in adjusted mean change: OPC-34712 - placebo|||0.18|-0.43|0.4166
72373774|NCT00797966|144258568|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.4193|TWO_SIDED|95.0|-0.35|0.15|||ANCOVA||Treatment difference = difference in adjusted mean change: OPC-34712 - placebo.|||0.15|-0.35|0.4193
72373775|NCT00797966|144258568|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.35||||0.0064|TWO_SIDED|95.0|-0.6|-0.1|||ANCOVA||Treatment difference = difference in adjusted mean change: OPC-34712 - placebo.|||-0.10|-0.60|0.0064
72373776|NCT00797966|144258569|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.68||||0.449|TWO_SIDED|95.0|-2.67|6.02|||ANCOVA||Treatment difference = difference in adjusted mean change: OPC-34712 - placebo.|||6.02|-2.67|0.4490
72373777|NCT00797966|144258569|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.61||||0.7412|TWO_SIDED|95.0|-3.02|4.24|||ANCOVA||Treatment difference = difference in adjusted mean change: OPC-34712 - placebo.|||4.24|-3.02|0.7412
72433041|NCT00530335|144379205|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value comparing difference in Hyperactivity/Impulsive Subscale scores (endpoint - baseline).|t-test, 2 sided|||||||<0.001
72373778|NCT00797966|144258569|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.54||||0.407|TWO_SIDED|95.0|-2.1|5.17|||ANCOVA||Treatment difference = difference in adjusted mean change: OPC-34712 - placebo.|||5.17|-2.10|0.4070
72433042|NCT00530335|144379205|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value comparing difference in ADHD Index Subscale scores (endpoint - baseline).|t-test, 2 sided|||||||<0.001
72373779|NCT00797966|144258570|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.22||||0.4954|TWO_SIDED|95.0|-0.86|0.42|||ANCOVA||Treatment difference = difference in adjusted mean change: OPC-34712 - placebo.|||0.42|-0.86|0.4954
72373780|NCT00797966|144258570|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.19||||0.4902|TWO_SIDED|95.0|-0.73|0.35|||ANCOVA||Treatment difference = difference in adjusted mean change: OPC-34712 - placebo.|||0.35|-0.73|0.4902
72373781|NCT00797966|144258570|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.66||||0.0161|TWO_SIDED|95.0|-1.2|-0.12|||ANCOVA||Treatment difference = difference in adjusted mean change: OPC-34712 - placebo.|||-0.12|-1.20|0.0161
72373782|NCT00797966|144258576|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.54||||0.5953|TWO_SIDED|95.0|-2.54|1.46|||ANCOVA||Treatment difference = difference in adjusted mean change: OPC-34712 - placebo.|||1.46|-2.54|0.5953
72373783|NCT00797966|144258576|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.05||||0.9479|TWO_SIDED|95.0|-1.66|1.55|||ANCOVA||Treatment difference = difference in adjusted mean change: OPC-34712 - placebo.|||1.55|-1.66|0.9479
72373784|NCT00797966|144258576|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.36||||0.0919|TWO_SIDED|95.0|-2.95|0.22|||ANCOVA||Treatment difference = difference in adjusted mean change: OPC-34712 - placebo.|||0.22|-2.95|0.0919
72373785|NCT00797966|144258577|SUPERIORITY_OR_OTHER|||||||0.3998||||||Cochran-Mantel-Haenszel row mean scores differ test controlling for study center.|Cochran-Mantel-Haenszel|||Week 9 values presented here.||||0.3998
72433043|NCT00530335|144379206|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value comparing difference in Total ADHD Symptoms Score (endpoint - baseline).|t-test, 2 sided|||||||<0.001
72433044|NCT00530335|144379206|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value comparing difference in Inattentive Subscale scores (endpoint - baseline).|t-test, 2 sided|||||||<0.001
72373786|NCT00797966|144258577|SUPERIORITY_OR_OTHER|||||||0.8838||||||Cochran-Mantel-Haenszel row mean scores differ test controlling for study center.|Cochran-Mantel-Haenszel|||Week 9 values presented here.||||0.8838
72373787|NCT00797966|144258577|SUPERIORITY_OR_OTHER|||||||0.4012||||||Cochran-Mantel-Haenszel row mean scores differ test controlling for study center.|Cochran-Mantel-Haenszel|||Week 9 values presented here.||||0.4012
72373788|NCT00797966|144258577|SUPERIORITY_OR_OTHER|||||||0.6131||||||Cochran-Mantel-Haenszel row mean scores differ test controlling for study center.|Cochran-Mantel-Haenszel|||Week 10 values presented here.||||0.6131
72373789|NCT00797966|144258577|SUPERIORITY_OR_OTHER|||||||0.5964||||||Cochran-Mantel-Haenszel row mean scores differ test controlling for study center.|Cochran-Mantel-Haenszel|||Week 10 values presented here.||||0.5964
72373790|NCT00797966|144258577|SUPERIORITY_OR_OTHER|||||||0.254||||||Cochran-Mantel-Haenszel row mean scores differ test controlling for study center.|Cochran-Mantel-Haenszel|||Week 10 values presented here.||||0.2540
72373791|NCT00797966|144258577|SUPERIORITY_OR_OTHER|||||||0.8524||||||Cochran-Mantel-Haenszel row mean scores differ test controlling for study center.|Cochran-Mantel-Haenszel|||Week 11 values presented here.||||0.8524
72373792|NCT00797966|144258577|SUPERIORITY_OR_OTHER|||||||0.6969||||||Cochran-Mantel-Haenszel row mean scores differ test controlling for study center.|Cochran-Mantel-Haenszel|||Week 11 values presented here.||||0.6969
72373793|NCT00797966|144258577|SUPERIORITY_OR_OTHER|||||||0.3108||||||Cochran-Mantel-Haenszel row mean scores differ test controlling for study center.|Cochran-Mantel-Haenszel|||Week 11 values presented here.||||0.3108
72373794|NCT00797966|144258577|SUPERIORITY_OR_OTHER|||||||0.8719||||||Cochran-Mantel-Haenszel row mean scores differ test controlling for study center.|Cochran-Mantel-Haenszel|||Week 12 values presented here.||||0.8719
72433045|NCT00530335|144379206|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value comparing difference in Hyperactive/Impulsive Subscale scores (endpoint - baseline).|t-test, 2 sided|||||||<0.001
72433046|NCT00530335|144379206|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value comparing difference in ADHD Index Subscale scores (endpoint - baseline).|t-test, 2 sided|||||||<0.001
72373795|NCT00797966|144258577|SUPERIORITY_OR_OTHER|||||||0.6105||||||Cochran-Mantel-Haenszel row mean scores differ test controlling for study center.|Cochran-Mantel-Haenszel|||Week 12 values presented here.||||0.6105
72373796|NCT00797966|144258577|SUPERIORITY_OR_OTHER|||||||0.0709||||||Cochran-Mantel-Haenszel row mean scores differ test controlling for study center.|Cochran-Mantel-Haenszel|||Week 12 values presented here.||||0.0709
72373797|NCT00797966|144258577|SUPERIORITY_OR_OTHER|||||||0.9574||||||Cochran-Mantel-Haenszel row mean scores differ test controlling for study center.|Cochran-Mantel-Haenszel|||Week 13 values presented here.||||0.9574
72373798|NCT00797966|144258577|SUPERIORITY_OR_OTHER|||||||0.231||||||Cochran-Mantel-Haenszel row mean scores differ test controlling for study center.|Cochran-Mantel-Haenszel|||Week 13 values presented here.||||0.2310
72373799|NCT00797966|144258577|SUPERIORITY_OR_OTHER|||||||0.0672||||||Cochran-Mantel-Haenszel row mean scores differ test controlling for study center.|Cochran-Mantel-Haenszel|||Week 13 values presented here.||||0.0672
72373800|NCT00797966|144258577|SUPERIORITY_OR_OTHER|||||||0.8441||||||Cochran-Mantel-Haenszel row mean scores differ test controlling for study center.|Cochran-Mantel-Haenszel|||Week 14 values presented here.||||0.8441
72373801|NCT00797966|144258577|SUPERIORITY_OR_OTHER|||||||0.6741||||||Cochran-Mantel-Haenszel row mean scores differ test controlling for study center.|Cochran-Mantel-Haenszel|||Week 14 values presented here.||||0.6741
72373802|NCT00797966|144258577|SUPERIORITY_OR_OTHER|||||||0.0183||||||Cochran-Mantel-Haenszel row mean scores differ test controlling for study center.|Cochran-Mantel-Haenszel|||Week 14 values presented here.||||0.0183
72373803|NCT00797966|144258578|SUPERIORITY_OR_OTHER||Ratio of Response Rate|0.49||||0.3007|TWO_SIDED|95.0|0.12|1.93||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 9 values presented here.||1.93|0.12|0.3007
72373804|NCT00797966|144258578|SUPERIORITY_OR_OTHER||Ratio of Response Rate|0.94||||0.8812|TWO_SIDED|95.0|0.42|2.1||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 9 values presented here.||2.10|0.42|0.8812
72373805|NCT00797966|144258578|SUPERIORITY_OR_OTHER||Ratio of Response Rate|0.32||||0.0553|TWO_SIDED|95.0|0.1|1.07||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 9 values presented here.||1.07|0.10|0.0553
72373806|NCT00797966|144258578|SUPERIORITY_OR_OTHER||Ratio of Response Rate|0.78||||0.6051|TWO_SIDED|95.0|0.3|2.05||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 10 values presented here.||2.05|0.30|0.6051
72373807|NCT00797966|144258578|SUPERIORITY_OR_OTHER||Ratio of Response Rate|0.92||||0.8264|TWO_SIDED|95.0|0.46|1.85||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 10 values presented here.||1.85|0.46|0.8264
72373808|NCT00797966|144258578|SUPERIORITY_OR_OTHER||Ratio of Response Rate|1.06||||0.869|TWO_SIDED|95.0|0.54|2.1||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 10 values presented here.||2.10|0.54|0.8690
72373809|NCT00797966|144258578|SUPERIORITY_OR_OTHER||Ratio of Response Rate|1.35||||0.3441|TWO_SIDED|95.0|0.74|2.44||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 11 values presented here.||2.44|0.74|0.3441
72373810|NCT00797966|144258578|SUPERIORITY_OR_OTHER||Ratio of Response Rate|1.14||||0.6375|TWO_SIDED|95.0|0.67|1.94||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 11 values presented here.||1.94|0.67|0.6375
72373811|NCT00797966|144258578|SUPERIORITY_OR_OTHER||Ratio of Response Rate|1.31||||0.3135|TWO_SIDED|95.0|0.78|2.21||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 11 values presented here.||2.21|0.78|0.3135
72373812|NCT00797966|144258578|SUPERIORITY_OR_OTHER||Ratio of Response Rate|2.35||||0.0035|TWO_SIDED|95.0|1.32|4.18||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 12 values presented here.||4.18|1.32|0.0035
72373813|NCT00797966|144258578|SUPERIORITY_OR_OTHER||Ratio of Response Rate|1.27||||0.4358|TWO_SIDED|95.0|0.7|2.31||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 12 values presented here.||2.31|0.70|0.4358
72373814|NCT00797966|144258578|SUPERIORITY_OR_OTHER||Ratio of Response Rate|2.02||||0.0063|TWO_SIDED|95.0|1.2|3.41||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 12 values presented here.||3.41|1.20|0.0063
72433047|NCT00530335|144379207|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||||||<0.001
72373815|NCT00797966|144258578|SUPERIORITY_OR_OTHER||Ratio of Response Rate|1.27||||0.3968|TWO_SIDED|95.0|0.72|2.23||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 13 values presented here.||2.23|0.72|0.3968
72373816|NCT00797966|144258578|SUPERIORITY_OR_OTHER||Ratio of Response Rate|1.27||||0.299|TWO_SIDED|95.0|0.81|2.0||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 13 values presented here.||2.00|0.81|0.2990
72373817|NCT00797966|144258578|SUPERIORITY_OR_OTHER||Ratio of Response Rate|1.39||||0.1614|TWO_SIDED|95.0|0.86|2.25||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 13 values presented here.||2.25|0.86|0.1614
72373818|NCT00797966|144258578|SUPERIORITY_OR_OTHER||Ratio of Response Rate|1.29||||0.3254|TWO_SIDED|95.0|0.79|2.12||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 14 values presented here.||2.12|0.79|0.3254
72373819|NCT00797966|144258578|SUPERIORITY_OR_OTHER||Ratio of Response Rate|1.02||||0.9463|TWO_SIDED|95.0|0.64|1.62||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 14 values presented here.||1.62|0.64|0.9463
72373820|NCT00797966|144258578|SUPERIORITY_OR_OTHER||Ratio of Response Rate|1.74||||0.008|TWO_SIDED|95.0|1.14|2.65||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 14 values presented here.||2.65|1.14|0.0080
72373821|NCT00797966|144258579|SUPERIORITY_OR_OTHER||Ratio of Remission Rate|0.59||||0.5791|TWO_SIDED|95.0|0.09|3.9||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 9 values presented here.||3.90|0.09|0.5791
72373822|NCT00797966|144258579|SUPERIORITY_OR_OTHER||Ratio of Remission Rate|0.43||||0.2653|TWO_SIDED|95.0|0.1|1.93||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 9 values presented here.||1.93|0.10|0.2653
72373823|NCT00797966|144258579|SUPERIORITY_OR_OTHER||Ratio of Remission Rate|0.39||||0.2259|TWO_SIDED|95.0|0.08|1.87||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 9 values presented here.||1.87|0.08|0.2259
72433048|NCT00530335|144379208|SUPERIORITY_OR_OTHER|||||||0.749||95.0|||||t-test, 2 sided|||||||0.749
72373824|NCT00797966|144258579|SUPERIORITY_OR_OTHER||Ratio of Remission Rate|0.83||||0.6986|TWO_SIDED|95.0|0.32|2.18||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 10 values presented here.||2.18|0.32|0.6986
72373825|NCT00797966|144258579|SUPERIORITY_OR_OTHER||Ratio of Remission Rate|0.61||||0.2339|TWO_SIDED|95.0|0.28|1.35||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 10 values presented here.||1.35|0.28|0.2339
72373826|NCT00797966|144258579|SUPERIORITY_OR_OTHER||Ratio of Remission Rate|1.07||||0.8615|TWO_SIDED|95.0|0.53|2.15||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 10 values presented here.||2.15|0.53|0.8615
72373827|NCT00797966|144258579|SUPERIORITY_OR_OTHER||Ratio of Remission Rate|1.06||||0.8807|TWO_SIDED|95.0|0.51|2.2||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 11 values presented here.||2.20|0.51|0.8807
72373828|NCT00797966|144258579|SUPERIORITY_OR_OTHER||Ratio of Remission Rate|0.96||||0.9035|TWO_SIDED|95.0|0.52|1.77||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 11 values presented here.||1.77|0.52|0.9035
72373829|NCT00797966|144258579|SUPERIORITY_OR_OTHER||Ratio of Remission Rate|1.19||||0.5898|TWO_SIDED|95.0|0.64|2.24|||Cochran-Mantel-Haenszel|||Week 11 values presented here.||2.24|0.64|0.5898
72373830|NCT00797966|144258579|SUPERIORITY_OR_OTHER||Ratio of Remission Rate|1.82||||0.084|TWO_SIDED|95.0|0.93|3.58||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 12 values presented here.||3.58|0.93|0.0840
72373831|NCT00797966|144258579|SUPERIORITY_OR_OTHER||Ratio of Remission Rate|0.96||||0.9115|TWO_SIDED|95.0|0.49|1.88||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 12 values presented here.||1.88|0.49|0.9115
72373832|NCT00797966|144258579|SUPERIORITY_OR_OTHER||Ratio of Remission Rate|1.77||||0.0522|TWO_SIDED|95.0|0.98|3.17||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 12 values presented here.||3.17|0.98|0.0522
72433049|NCT00530335|144379209|SUPERIORITY_OR_OTHER|||||||0.886||95.0|||||t-test, 2 sided|||||||0.886
72433050|NCT00530335|144379211|SUPERIORITY_OR_OTHER|||||||0.005||95.0||||P-value for comparing differences in Word Test number of correct responses (endpoint - baseline).|t-test, 2 sided|||||||0.005
72373833|NCT00797966|144258579|SUPERIORITY_OR_OTHER||Ratio of Remission Rate|1.24||||0.4997|TWO_SIDED|95.0|0.65|2.34||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 13 values presented here.||2.34|0.65|0.4997
72433051|NCT00530335|144379211|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for comparing differences in Color Test number of correct responses (endpoint - baseline).|t-test, 2 sided|||||||<0.001
72433052|NCT00530335|144379211|SUPERIORITY_OR_OTHER|||||||0.003||95.0||||P-value for comparing differences in Color-Word Test number of correct responses (endpoint - baseline).|t-test, 2 sided|||||||0.003
72373834|NCT00797966|144258579|SUPERIORITY_OR_OTHER||Ratio of Remission Rate|1.16||||0.5846|TWO_SIDED|95.0|0.69|1.93||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 13 values presented here.||1.93|0.69|0.5846
72373835|NCT00797966|144258579|SUPERIORITY_OR_OTHER||Ratio of Remission Rate|0.99||||0.9602|TWO_SIDED|95.0|0.55|1.76||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 13 values presented here.||1.76|0.55|0.9602
72373836|NCT00797966|144258579|SUPERIORITY_OR_OTHER||Ratio of Remission Rate|1.62||||0.1254|TWO_SIDED|95.0|0.87|3.02||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 14 values presented here.||3.02|0.87|0.1254
72373837|NCT00797966|144258579|SUPERIORITY_OR_OTHER||Ratio of Remission Rate|1.13||||0.667|TWO_SIDED|95.0|0.65|1.99||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 14 values presented here.||1.99|0.65|0.6670
72373838|NCT00797966|144258579|SUPERIORITY_OR_OTHER||Ratio of Remission Rate|1.7||||0.0525|TWO_SIDED|95.0|0.98|2.93||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 14 values presented here.||2.93|0.98|0.0525
72433053|NCT00672256|144379249|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.039|||<|0.05||95.0|||||Paired t-test|||Within group repeated measures design. Null hypothesis is that there will be no difference in percent signal change during active task relative to baseline.||||<0.05
72433054|NCT00672256|144379250|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.104|||<|0.05||95.0|||||Paired t-test|||Within group repeated measures design. Null hypothesis is that there will be no difference in percent signal change during active task relative to baseline.||||<0.05
72433055|NCT00672256|144379251|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.173|||<|0.05||95.0|||||Paired t-test|||Within group repeated measures design. Null hypothesis is that there will be no difference in percent signal change during active task relative to baseline.||||<0.05
72433056|NCT00672256|144379252|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.169|||<|0.05||95.0|||||Paired t-test|||Within group repeated measures design. Null hypothesis is that there will be no difference in percent signal change during active task relative to baseline.||||<0.05
72433057|NCT01268891|144379256|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.35|STANDARD_ERROR_OF_MEAN|0.35||0.3257|TWO_SIDED|90.0|-0.93|0.23||The threshold for statistical significance in showing a trend for this study is 0.10.|ANCOVA|||The power for this study, which is designed to show a trend, that is, to show a clinical difference in the primary outcome measure, is 72%.||0.23|-0.93|0.3257
72433058|NCT01268891|144379257|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.18||0.0946|TWO_SIDED|95.0|-0.65|0.05|||ANCOVA|||||0.05|-0.65|0.0946
72433059|NCT01268891|144379258|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|0.57||0.2258|TWO_SIDED|95.0|-1.84|0.44|||ANCOVA|||||0.44|-1.84|0.2258
72433060|NCT01268891|144379259|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.35|STANDARD_ERROR_OF_MEAN|0.98||0.17|TWO_SIDED|95.0|-3.29|0.59|||ANCOVA|||||0.59|-3.29|0.1700
72433061|NCT01720043|144379262|SUPERIORITY|||||||0.181|||||||t-test, 2 sided|||Collagen.5.g.ml, 24 hrs||||0.181
72433062|NCT01720043|144379262|SUPERIORITY|||||||0.164|||||||t-test, 2 sided|||Collagen.2.g.ml||||.164
72433063|NCT01720043|144379262|SUPERIORITY|||||||0.132|||||||t-test, 2 sided|||ADP.10.M, 24 hrs||||.132
72433064|NCT01720043|144379262|SUPERIORITY|||||||0.066|||||||t-test, 2 sided|||ADP.5.M||||.066
72433065|NCT01720043|144379262|SUPERIORITY|||||||0.268|||||||t-test, 2 sided|||ADP.3.M, 24 hrs||||0.268
72433066|NCT01720043|144379262|SUPERIORITY|||||||0.106|||||||t-test, 2 sided|||Arach.Acid.0.5.mg.ml||||0.106
72433067|NCT01720043|144379262|SUPERIORITY|||||||0.625|||||||t-test, 2 sided|||Ristocetin.1.5.mg.ml||||0.625
72433068|NCT01720043|144379262|SUPERIORITY|||||||0.381|||||||t-test, 2 sided|||Ristocetin.0.5.mg.ml||||0.381
72433069|NCT01720043|144379262|SUPERIORITY|||||||0.549|||||||t-test, 2 sided|||Collagen.5.g.ml, 48 hrs||||0.549
72433070|NCT01720043|144379262|SUPERIORITY|||||||0.838|||||||t-test, 2 sided|||Collagen.2.g.ml, 48 hrs||||.838
72433071|NCT01720043|144379262|SUPERIORITY|||||||0.245|||||||t-test, 2 sided|||ADP.10.M||||0.245
72433072|NCT01720043|144379262|SUPERIORITY|||||||0.417|||||||t-test, 2 sided|||ADP.5.M||||0.417
72433073|NCT01720043|144379262|SUPERIORITY|||||||0.77|||||||t-test, 2 sided|||ADP.3.M, 48 hrs||||0.770
72433074|NCT01720043|144379262|SUPERIORITY|||||||0.614|||||||t-test, 2 sided|||Arach.Acid.0.5.mg.ml, 48 hrs||||0.614
72433075|NCT01720043|144379262|SUPERIORITY|||||||0.969|||||||t-test, 2 sided|||Ristochetin.1.5.mg.ml||||0.969
72433076|NCT01720043|144379262|SUPERIORITY|||||||0.238|||||||t-test, 2 sided|||Ristocetin.0.5.mg.ml, 48 hrs||||0.238
72433077|NCT02022462|144379263|SUPERIORITY|||||||0.073|||||||t-test, 2 sided|||Baseline to 6 months between-group comparisons of the mean change of z-scores.||||.073
72433078|NCT02022462|144379263|SUPERIORITY||Mean Difference (Net)|0.19|STANDARD_DEVIATION|0.91||0.066|TWO_SIDED||||||t-test, 2 sided|||Within-group mean z-score change from 6 months to 12-months (post-intervention) for the immediate treatment group only.||||.066
72433079|NCT02022462|144379264|SUPERIORITY||Mean Difference (Final Values)|0.022||||0.983|TWO_SIDED||||||t-test, 2 sided|||Baseline to 6 months between-group comparisons of the mean change.||||.983
72433080|NCT02022462|144379264|SUPERIORITY||Mean Difference (Net)|0.17|STANDARD_DEVIATION|1.95||0.533|TWO_SIDED||||||t-test, 2 sided|||Within-group mean change from 6 months to 12-months (post-intervention) for the immediate treatment group only.||||.533
72433081|NCT02022462|144379265|SUPERIORITY|||||||0.731|||||||t-test, 2 sided|||Baseline to 6 months between-group comparisons of the mean change.||||.731
72433082|NCT02022462|144379265|SUPERIORITY||Mean Difference (Final Values)|0.29|STANDARD_DEVIATION|1.67||0.211|TWO_SIDED||||||t-test, 2 sided|||Within-group mean change from 6 months to 12-months (post-intervention) for the immediate treatment group only.||||.211
72433083|NCT02022462|144379266|SUPERIORITY||Mean Difference (Net)|0.04||||0.244|TWO_SIDED||||||t-test, 2 sided|||Baseline to 6 months between-group comparisons of the mean change.||||.244
72433084|NCT02022462|144379266|SUPERIORITY||Mean Difference (Net)|0.13|STANDARD_DEVIATION|0.35||0.016|TWO_SIDED||||||t-test, 2 sided|||||||.016
72433085|NCT02022462|144379267|SUPERIORITY||Mean Difference (Net)|0.4||||0.019|TWO_SIDED||||||t-test, 2 sided|||Baseline to 6 months between-group comparisons of the mean change.||||.019
72433086|NCT02022462|144379267|SUPERIORITY||Mean Difference (Net)|0.05|STANDARD_DEVIATION|0.66||0.609|TWO_SIDED||||||t-test, 2 sided|||||||.609
72433087|NCT02022462|144379268|SUPERIORITY|||||||0.203|||||||t-test, 2 sided|||Baseline to 6 months between-group comparisons of the mean change.||||.203
72433088|NCT02022462|144379268|SUPERIORITY||Mean Difference (Net)|-0.06|STANDARD_DEVIATION|0.59||0.48|TWO_SIDED||||||t-test, 2 sided|||||||.480
72433089|NCT02022462|144379269|SUPERIORITY||Mean Difference (Net)|0.01||||0.897|TWO_SIDED||||||t-test, 2 sided|||||||.897
72433090|NCT02022462|144379269|SUPERIORITY||Mean Difference (Net)|0.01|STANDARD_DEVIATION|0.48||0.903|TWO_SIDED||||||t-test, 2 sided|||||||.903
72433091|NCT02022462|144379270|SUPERIORITY||Mean Difference (Net)|-0.787||||0.433|TWO_SIDED||||||t-test, 2 sided|||Baseline to 6 months between-group comparisons of the mean change.||||.433
72433092|NCT02022462|144379270|SUPERIORITY||Mean Difference (Net)|0.01|STANDARD_DEVIATION|0.52||0.936|TWO_SIDED||||||t-test, 2 sided|||||||.936
72433093|NCT02022462|144379271|SUPERIORITY|||||||0.228|||||||t-test, 2 sided|||Baseline to 6 months between-group comparisons of the mean change in z-scores of diet.||||.228
72433094|NCT02022462|144379271|SUPERIORITY||Mean Difference (Net)|0.07|STANDARD_DEVIATION|1.03||0.617|TWO_SIDED||||||t-test, 2 sided|||||||.617
72433095|NCT02022462|144379272|SUPERIORITY||Mean Difference (Net)|0.01||||0.894|TWO_SIDED||||||t-test, 2 sided|||||||.894
72433096|NCT02022462|144379272|SUPERIORITY||Mean Difference (Net)|0.01|STANDARD_DEVIATION|0.46||0.93|TWO_SIDED||||||t-test, 2 sided|||||||.930
72433097|NCT02022462|144379273|SUPERIORITY||Mean Difference (Net)|0.15||||0.53|TWO_SIDED||||||t-test, 2 sided|||||||.530
72433098|NCT02022462|144379273|SUPERIORITY||Mean Difference (Net)|-0.13|STANDARD_DEVIATION|1.27||0.458|TWO_SIDED||||||t-test, 2 sided|||||||.458
72433099|NCT02022462|144379274|SUPERIORITY||Mean Difference (Net)|0.31||||0.036|TWO_SIDED||||||t-test, 2 sided|||||||.036
72433100|NCT02022462|144379274|SUPERIORITY||Mean Difference (Net)|0.02|STANDARD_DEVIATION|1.0||0.892|TWO_SIDED||||||t-test, 2 sided|||||||.892
72433101|NCT02022462|144379275|SUPERIORITY||Mean Difference (Net)|0.41||||0.931|TWO_SIDED||||||t-test, 2 sided|||||||.931
72433102|NCT02022462|144379275|SUPERIORITY||Mean Difference (Net)|-6.43|STANDARD_DEVIATION|24.34||0.058|TWO_SIDED||||||t-test, 2 sided|||||||.058
72433103|NCT02022462|144379276|SUPERIORITY||Mean Difference (Net)|0.4||||0.576|TWO_SIDED||||||t-test, 2 sided|||||||.576
72433104|NCT02022462|144379276|SUPERIORITY||Mean Difference (Net)|-1.06|STANDARD_DEVIATION|33.89||0.829|TWO_SIDED||||||t-test, 2 sided|||||||.829
72433105|NCT02022462|144379277|SUPERIORITY|||||||0.792|||||||t-test, 2 sided|||Baseline to 6 months between-group comparisons of the mean change.||||.792
72433106|NCT02022462|144379277|SUPERIORITY||Mean Difference (Net)|0.04|STANDARD_DEVIATION|0.55||0.622|TWO_SIDED||||||t-test, 2 sided|||||||.622
72433107|NCT02022462|144379278|SUPERIORITY||Mean Difference (Net)|1.986||||0.049|TWO_SIDED||||||t-test, 2 sided|||Baseline to 6 months between-group comparisons of the mean change.||||.049
72433108|NCT02022462|144379278|SUPERIORITY||Mean Difference (Net)|0.29|STANDARD_DEVIATION|1.67||0.211|TWO_SIDED||||||t-test, 2 sided|||||||.211
72433109|NCT00938340|144379283|SUPERIORITY_OR_OTHER_LEGACY|||||||0.012||95.0|||||Mixed Models Analysis|||||||0.012
72433110|NCT00938340|144379283|SUPERIORITY_OR_OTHER_LEGACY|||||||0.52||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.0083 is considered significant (6 comparisons).|Mixed Models Analysis|||||||0.52
72433111|NCT00938340|144379283|SUPERIORITY_OR_OTHER_LEGACY|||||||0.011||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.0083 is considered significant (6 comparisons).|Mixed Models Analysis|||||||0.011
72433112|NCT00938340|144379283|SUPERIORITY_OR_OTHER_LEGACY|||||||0.29||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.0083 is considered significant (6 comparisons).|Mixed Models Analysis|||||||0.29
72433113|NCT00938340|144379283|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.0083 is considered significant (6 comparisons).|Mixed Models Analysis|||||||0.002
72433114|NCT00938340|144379283|SUPERIORITY_OR_OTHER_LEGACY|||||||0.093||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.0083 is considered significant (6 comparisons).|Mixed Models Analysis|||||||0.093
72433115|NCT00938340|144379283|SUPERIORITY_OR_OTHER_LEGACY|||||||0.12||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.0083 is considered significant (6 comparisons).|Mixed Models Analysis|||||||0.12
72555362|NCT00830024|144642275|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|An analysis of variance (ANOVA) was performed on each of the pharmacokinetic parameters using SAS® software.|Geometric Test/Ref Ratio x 100|95.89||||||90.0|91.67|100.31|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||100.31|91.67|
72555363|NCT00950989|144642301|SUPERIORITY||Difference in response rate|3.2||||0.598|TWO_SIDED|95.0|-9.0|15.4||P-value is nominal p-value without multiplicity adjustment based on Cochran-Mantel-Haenszel test adjusting for sex.|Cochran-Mantel-Haenszel|||||15.4|-9.0|0.598
72433116|NCT00938340|144379284|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.01|||||||Mixed Models Analysis|||||||<0.01
72433117|NCT00938340|144379284|SUPERIORITY_OR_OTHER_LEGACY|||||||0.15||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.0083 is considered significant (6 comparisons).|Mixed Models Analysis|||||||0.15
72433118|NCT00938340|144379284|SUPERIORITY_OR_OTHER_LEGACY|||||||0.35||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.0083 is considered significant (6 comparisons).|Mixed Models Analysis|||||||0.35
72433119|NCT00938340|144379284|SUPERIORITY_OR_OTHER_LEGACY|||||||0.011||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.0083 is considered significant (6 comparisons).|Mixed Models Analysis|||||||0.011
72433120|NCT00938340|144379284|SUPERIORITY_OR_OTHER_LEGACY|||||||0.62||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.0083 is considered significant (6 comparisons).|Mixed Models Analysis|||||||0.62
72433121|NCT00938340|144379284|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0002||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.0083 is considered significant (6 comparisons).|Mixed Models Analysis|||||||0.0002
72433122|NCT00938340|144379284|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0013||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.0083 is considered significant (6 comparisons).|Mixed Models Analysis|||||||0.0013
72433123|NCT00938340|144379285|SUPERIORITY_OR_OTHER_LEGACY|||||||0.15||||||Main effect of treatment by timepoint|Mixed Models Analysis|||||||0.15
72433124|NCT00938340|144379286|SUPERIORITY_OR_OTHER_LEGACY|||||||0.79|||||||Mixed Models Analysis|||||||0.79
72433125|NCT00938340|144379287|SUPERIORITY_OR_OTHER_LEGACY|||||||0.01|||||||Mixed Models Analysis|||||||0.010
72433126|NCT00938340|144379287|SUPERIORITY_OR_OTHER_LEGACY|||||||0.98||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.0083 is considered significant (6 comparisons).|Mixed Models Analysis|||||||0.98
72433127|NCT00938340|144379287|SUPERIORITY_OR_OTHER_LEGACY|||||||0.004||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.0083 is considered significant (6 comparisons).|Mixed Models Analysis|||||||0.004
72433128|NCT00938340|144379287|SUPERIORITY_OR_OTHER_LEGACY|||||||0.11||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.0083 is considered significant (6 comparisons).|Mixed Models Analysis|||||||0.11
72433129|NCT00938340|144379287|SUPERIORITY_OR_OTHER_LEGACY|||||||0.004||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.0083 is considered significant (6 comparisons).|Mixed Models Analysis|||||||0.004
72433130|NCT00938340|144379287|SUPERIORITY_OR_OTHER_LEGACY|||||||0.11||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.0083 is considered significant (6 comparisons).|Mixed Models Analysis|||||||0.11
72373839|NCT00797966|144258580|SUPERIORITY_OR_OTHER||Ratio of Response Rate|0.98||||0.9462|TWO_SIDED|95.0|0.52|1.84||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 9 values presented here.||1.84|0.52|0.9462
72373840|NCT00797966|144258580|SUPERIORITY_OR_OTHER||Ratio of Response Rate|0.8||||0.4971|TWO_SIDED|95.0|0.43|1.49||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 9 values presented here.||1.49|0.43|0.4971
72373841|NCT00797966|144258580|SUPERIORITY_OR_OTHER||Ratio of Response Rate|0.93||||0.8118|TWO_SIDED|95.0|0.53|1.63||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 9 values presented here.||1.63|0.53|0.8118
72373842|NCT00797966|144258580|SUPERIORITY_OR_OTHER||Ratio of Response Rate|0.95||||0.8323|TWO_SIDED|95.0|0.59|1.53||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 10 values presented here.||1.53|0.59|0.8323
72373843|NCT00797966|144258580|SUPERIORITY_OR_OTHER||Ratio of Response Rate|0.68||||0.093|TWO_SIDED|95.0|0.43|1.08||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 10 values presented here.||1.08|0.43|0.0930
72373844|NCT00797966|144258580|SUPERIORITY_OR_OTHER||Ratio of Response Rate|0.88||||0.553|TWO_SIDED|95.0|0.59|1.32||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 10 values presented here.||1.32|0.59|0.5530
72373845|NCT00797966|144258580|SUPERIORITY_OR_OTHER||Ratio of Response Rate|1.06||||0.8007|TWO_SIDED|95.0|0.69|1.61||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 11 values presented here.||1.61|0.69|0.8007
72373846|NCT00797966|144258580|SUPERIORITY_OR_OTHER||Ratio of Response Rate|1.03||||0.8945|TWO_SIDED|95.0|0.71|1.49||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 11 values presented here.||1.49|0.71|0.8945
72373847|NCT00797966|144258580|SUPERIORITY_OR_OTHER||Ratio of Response Rate|1.17||||0.3837|TWO_SIDED|95.0|0.83|1.64||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 11 values presented here.||1.64|0.83|0.3837
72373848|NCT00797966|144258580|SUPERIORITY_OR_OTHER||Ratio of Response Rate|1.09||||0.7064|TWO_SIDED|95.0|0.72|1.63||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 12 values presented here.||1.63|0.72|0.7064
72373849|NCT00797966|144258580|SUPERIORITY_OR_OTHER||Ratio of Response Rate|1.06||||0.7469|TWO_SIDED|95.0|0.74|1.52||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 12 values presented here.||1.52|0.74|0.7469
72373850|NCT00797966|144258580|SUPERIORITY_OR_OTHER||Ratio of Response Rate|1.34||||0.0832|TWO_SIDED|95.0|0.97|1.86||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 12 values presented here.||1.86|0.97|0.0832
72373851|NCT00797966|144258580|SUPERIORITY_OR_OTHER||Ratio of Response Rate|1.09||||0.6611|TWO_SIDED|95.0|0.74|1.61||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 13 values presented here.||1.61|0.74|0.6611
72373852|NCT00797966|144258580|SUPERIORITY_OR_OTHER||Ratio of Response Rate|1.13||||0.4435|TWO_SIDED|95.0|0.83|1.56||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 13 values presented here.||1.56|0.83|0.4435
72433131|NCT00938340|144379287|SUPERIORITY_OR_OTHER_LEGACY|||||||0.16||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.0083 is considered significant (6 comparisons).|Mixed Models Analysis|||||||0.16
72373853|NCT00797966|144258580|SUPERIORITY_OR_OTHER||Ratio of Response Rate|1.47||||0.0118|TWO_SIDED|95.0|1.09|1.98||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 13 values presented here.||1.98|1.09|0.0118
72373854|NCT00797966|144258580|SUPERIORITY_OR_OTHER||Ratio of Response Rate|0.89||||0.5111|TWO_SIDED|95.0|0.63|1.26||Cochran-Mantel-Haenszel general association test controlling for study center.|Chi-squared, Corrected|||Week 14 values presented here.||1.26|0.63|0.5111
72373855|NCT00797966|144258580|SUPERIORITY_OR_OTHER||Ratio of Response Rate|0.9||||0.4903|TWO_SIDED|95.0|0.66|1.22||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 14 values presented here.||1.22|0.66|0.4903
72373856|NCT00797966|144258580|SUPERIORITY_OR_OTHER||Ratio of Response Rate|1.28||||0.0662|TWO_SIDED|95.0|0.98|1.67||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 14 values presented here.||1.67|0.98|0.0662
72373857|NCT03859973|144258594|OTHER||Mean Difference (Net)|-0.866||||0.3101|TWO_SIDED|95.0|-2.605|0.833|||Mixed Models Analysis||Least Square Mean of (BI 425809 10 mg + Computerized Cognitive Training) - Least Square Mean of (Placebo + Computerized Cognitive Training)|Restricted maximum likelihood (REML) based approach using a mixed model with repeated measurements (MMRM) which included the following fixed effects: categorical factor of planned treatment, visit (screening, baseline, week 6 and Week 12), planned treatment by visit interaction, continuous covariate of baseline value, baseline by visit interaction, categorical factor of age group, and continuous covariate of change from screening to baseline value.||0.833|-2.605|0.3101
72373858|NCT03859973|144258595|OTHER||Mean Difference (Net)|-1.051||||0.2309|TWO_SIDED|95.0|-2.778|0.676|||Mixed Models Analysis||Least Square Mean of (BI 425809 10 mg + Computerized Cognitive Training) - Least Square Mean of (Placebo + Computerized Cognitive Training)|Restricted maximum likelihood (REML) based approach using a mixed model with repeated measurements (MMRM) which included the following fixed effects: categorical factor of planned treatment, visit (screening, baseline, week 6 and Week 12), planned treatment by visit interaction, continuous covariate of baseline value, baseline by visit interaction, categorical factor of age group, and continuous covariate of change from screening to baseline value.||0.676|-2.778|0.2309
72433132|NCT00938340|144379288|SUPERIORITY_OR_OTHER_LEGACY|||||||0.007|||||||Mixed Models Analysis|||||||0.007
72433133|NCT00938340|144379288|SUPERIORITY_OR_OTHER_LEGACY|||||||0.004||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.0083 is considered significant (6 comparisons).|Mixed Models Analysis|||||||0.004
72433134|NCT00938340|144379288|SUPERIORITY_OR_OTHER_LEGACY|||||||0.62||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.0083 is considered significant (6 comparisons).|Mixed Models Analysis|||||||0.62
72433135|NCT00938340|144379288|SUPERIORITY_OR_OTHER_LEGACY|||||||0.14||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.0083 is considered significant (6 comparisons).|Mixed Models Analysis|||||||0.14
72373859|NCT03859973|144258596|OTHER||Mean Difference (Net)|0.577||||0.5237|TWO_SIDED|95.0|-1.207|2.362|||ANCOVA||Least Square Mean of (BI 425809 10 mg + Computerized Cognitive Training) - Least Square Mean of (Placebo + Computerized Cognitive Training)|Analysis of Covariance (ANCOVA) which included the following fixed effects: categorical factor of planned treatment, continuous covariate of baseline value, categorical factor of age group.||2.362|-1.207|0.5237
72373860|NCT03859973|144258597|OTHER||Mean Difference (Net)|-0.669||||0.642|TWO_SIDED|95.0|-3.51|2.172|||Mixed Models Analysis||Least Square Mean of (BI 425809 10 mg + Computerized Cognitive Training) - Least Square Mean of (Placebo + Computerized Cognitive Training)|Restricted maximum likelihood (REML) based approach using a mixed model with repeated measurements (MMRM) which included the following fixed effects: categorical factor of planned treatment, visit (baseline, Week 6 and Week 12), planned treatment by visit interaction, continuous covariate of baseline value, baseline by visit interaction, categorical factor of age group.||2.172|-3.510|0.6420
72373861|NCT01478048|144258599|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.72||||0.0923|TWO_SIDED|95.0|0.49|1.06||Log Rank test was stratified by prior proteasome inhibitor use (Yes versus No), presence of at least 1 FcγRIIIa V allele (Yes versus No) and number of prior lines of therapy (1 versus 2 or 3) at randomization|Log Rank|Adjusted alpha level= 0.30||||1.06|0.49|0.0923
72373862|NCT01478048|144258602|SUPERIORITY_OR_OTHER||Difference using Chan-Zhang method|2.3|||||TWO_SIDED|95.0|-13.2|17.8||||||||17.8|-13.2|
72373863|NCT00955201|144258605|SUPERIORITY|||||||0.49||||||Tukey's multiple comparisons test|ANOVA|Comparison to baseline values||Evaluated within group across time||||0.49
72373864|NCT00955201|144258605|SUPERIORITY|||||||0.82||||||Tukey's multiple comparisons test|ANOVA|||Evaluated within group across time||||0.82
72373865|NCT00955201|144258605|SUPERIORITY|||||||0.96||||||Tukey's multiple comparisons test|ANOVA|||Evaluated within group across time||||0.96
72373866|NCT00955201|144258605|SUPERIORITY|||||||0.93||||||Tukey's multiple comparisons test|ANOVA|||Evaluated within group across time||||0.93
72373867|NCT00955201|144258605|SUPERIORITY|||||||0.63|||||||ANOVA|||Comparison across groups at baseline||||0.63
72373868|NCT00955201|144258605|SUPERIORITY|||||||0.31|||||||ANOVA|||Comparison across groups at 12-wk||||0.31
72373869|NCT00955201|144258605|SUPERIORITY|||||||0.28|||||||ANOVA|||Comparison across groups at 24-wk||||0.28
72373870|NCT00955201|144258606|SUPERIORITY|||||||0.53||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time||||0.53
72373871|NCT00955201|144258606|SUPERIORITY|||||||1||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time||||1.00
72373872|NCT00955201|144258606|SUPERIORITY|||||||1||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time||||1.00
72373873|NCT00955201|144258606|SUPERIORITY|||||||0.93||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time||||0.93
72373874|NCT00955201|144258606|SUPERIORITY|||||||0.8|||||||ANOVA|||Comparison across groups at baseline.||||0.80
72373875|NCT00955201|144258606|SUPERIORITY|||||||0.63|||||||ANOVA|||Comparison across groups at 12-wks||||0.63
72373876|NCT00955201|144258606|SUPERIORITY|||||||0.31|||||||ANOVA|||Comparison across groups at 24-wk||||0.31
72373877|NCT00955201|144258607|SUPERIORITY|||||||0.39||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time||||0.39
72373878|NCT00955201|144258607|SUPERIORITY|||||||1||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time||||1.00
72373879|NCT00955201|144258607|SUPERIORITY|||||||1||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time||||1.00
72373880|NCT00955201|144258607|SUPERIORITY|||||||0.98||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time||||0.98
72373881|NCT00955201|144258607|SUPERIORITY|||||||0.7|||||||ANOVA|||Comparison across groups at baseline||||0.70
72373882|NCT00955201|144258607|SUPERIORITY|||||||0.45|||||||ANOVA|||Comparison across groups at 12-wks||||0.45
72373883|NCT00955201|144258607|SUPERIORITY|||||||0.22|||||||ANOVA|||Comparison across groups at 24-wks||||0.22
72373884|NCT00955201|144258608|SUPERIORITY|||||||0.98||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time||||0.98
72373885|NCT00955201|144258608|SUPERIORITY|||||||0.9||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time||||0.90
72373886|NCT00955201|144258608|SUPERIORITY|||||||0.97||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time||||0.97
72373887|NCT00955201|144258608|SUPERIORITY|||||||0.78||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time||||0.78
72373888|NCT00955201|144258608|SUPERIORITY|||||||0.63|||||||ANOVA|||Comparison across groups at baseline||||0.63
72373889|NCT00955201|144258608|SUPERIORITY|||||||0.97|||||||ANOVA|||Comparison across groups at 12-wk||||0.97
72373890|NCT00955201|144258608|SUPERIORITY|||||||0.99|||||||ANOVA|||Comparison across groups at 24-wks||||0.99
72433136|NCT00938340|144379288|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.0083 is considered significant (6 comparisons).|Mixed Models Analysis|||||||0.002
72433137|NCT00938340|144379288|SUPERIORITY_OR_OTHER_LEGACY|||||||0.22||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.0083 is considered significant (6 comparisons).|Mixed Models Analysis|||||||0.22
72433138|NCT00938340|144379288|SUPERIORITY_OR_OTHER_LEGACY|||||||0.074||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.0083 is considered significant (6 comparisons).|Mixed Models Analysis|||||||0.074
72433139|NCT00938340|144379289|SUPERIORITY_OR_OTHER_LEGACY|||||||0.53|||||||Mixed Models Analysis|||||||0.53
72433140|NCT00938340|144379290|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|||||||Mixed Models Analysis|||||||>0.05
72433141|NCT00938340|144379291|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|||||||Mixed Models Analysis|||||||>0.05
72433142|NCT00938340|144379292|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|||||||Mixed Models Analysis|||||||>0.05
72433143|NCT00938340|144379293|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|||||||Mixed Models Analysis|||||||>0.05
72433144|NCT00938340|144379294|SUPERIORITY_OR_OTHER_LEGACY|||||||0.44|||||||Mixed Models Analysis|||||||0.44
72433145|NCT00938340|144379295|SUPERIORITY_OR_OTHER_LEGACY|||||||0.62|||||||Mixed Models Analysis|||||||0.62
72433146|NCT00938340|144379296|SUPERIORITY_OR_OTHER_LEGACY|||||||0.011|||||||Mixed Models Analysis|||||||0.011
72433147|NCT00938340|144379296|SUPERIORITY_OR_OTHER_LEGACY|||||||0.007||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.0083 is considered significant (6 comparisons).|Mixed Models Analysis|||||||0.007
72433148|NCT00938340|144379296|SUPERIORITY_OR_OTHER_LEGACY|||||||0.99||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.0083 is considered significant (6 comparisons).|Mixed Models Analysis|||||||0.99
72433149|NCT00938340|144379296|SUPERIORITY_OR_OTHER_LEGACY|||||||0.037||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.0083 is considered significant (6 comparisons).|Mixed Models Analysis|||||||0.037
72433150|NCT00938340|144379296|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0087||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.0083 is considered significant (6 comparisons).|Mixed Models Analysis|||||||0.0087
72433151|NCT00938340|144379296|SUPERIORITY_OR_OTHER_LEGACY|||||||0.64||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.0083 is considered significant (6 comparisons).|Mixed Models Analysis|||||||0.64
72433152|NCT00938340|144379296|SUPERIORITY_OR_OTHER_LEGACY|||||||0.043||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.0083 is considered significant (6 comparisons).|Mixed Models Analysis|||||||0.043
72433153|NCT00938340|144379297|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||Mixed Models Analysis|||||||<0.0001
72433154|NCT00938340|144379297|SUPERIORITY_OR_OTHER_LEGACY|||||||0.91||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.001667 is considered significant (30 comparisons).|Mixed Models Analysis|||||||0.91
72433155|NCT00938340|144379297|SUPERIORITY_OR_OTHER_LEGACY|||||||0.21||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.001667 is considered significant (30 comparisons).|Mixed Models Analysis|||||||0.21
72433156|NCT00938340|144379297|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0011||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.001667 is considered significant (30 comparisons).|Mixed Models Analysis|||||||0.0011
72555364|NCT00950989|144642301|SUPERIORITY|||||||0.993||||||Adjusted p-value is based on a combination of sequential testing and the Hommel procedure to control the overall significance level for all the comparisons.|Sequential testing + Hommel procedure|||||||0.993
72433157|NCT00938340|144379297|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0004||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.001667 is considered significant (30 comparisons).|Mixed Models Analysis|||||||0.0004
72433158|NCT00938340|144379297|SUPERIORITY_OR_OTHER_LEGACY|||||||0.11||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.001667 is considered significant (30 comparisons).|Mixed Models Analysis|||||||0.11
72433159|NCT00938340|144379297|SUPERIORITY_OR_OTHER_LEGACY|||||||0.53||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.001667 is considered significant (30 comparisons).|Mixed Models Analysis|||||||0.53
72433160|NCT00938340|144379297|SUPERIORITY_OR_OTHER_LEGACY|||||||0.59||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.001667 is considered significant (30 comparisons).|Mixed Models Analysis|||||||0.59
72433161|NCT00938340|144379297|SUPERIORITY_OR_OTHER_LEGACY|||||||0.31||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.001667 is considered significant (30 comparisons).|Mixed Models Analysis|||||||0.31
72433162|NCT00938340|144379297|SUPERIORITY_OR_OTHER_LEGACY|||||||0.98||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.001667 is considered significant (30 comparisons).|Mixed Models Analysis|||||||0.98
72433163|NCT00938340|144379297|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.001667 is considered significant (30 comparisons).|Mixed Models Analysis|||||||0.30
72433164|NCT00938340|144379297|SUPERIORITY_OR_OTHER_LEGACY|||||||0.91||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.001667 is considered significant (30 comparisons).|Mixed Models Analysis|||||||0.91
72433165|NCT00938340|144379297|SUPERIORITY_OR_OTHER_LEGACY|||||||0.12||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.001667 is considered significant (30 comparisons).|Mixed Models Analysis|||||||0.12
72433166|NCT00938340|144379297|SUPERIORITY_OR_OTHER_LEGACY|||||||0.007||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.001667 is considered significant (30 comparisons).|Mixed Models Analysis|||||||0.007
72433167|NCT00938340|144379297|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0089||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.001667 is considered significant (30 comparisons).|Mixed Models Analysis|||||||0.0089
72433168|NCT00938340|144379297|SUPERIORITY_OR_OTHER_LEGACY|||||||0.28||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.001667 is considered significant (30 comparisons).|Mixed Models Analysis|||||||0.28
72433169|NCT00938340|144379297|SUPERIORITY_OR_OTHER_LEGACY|||||||0.62||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.001667 is considered significant (30 comparisons).|Mixed Models Analysis|||||||0.62
72433170|NCT00938340|144379297|SUPERIORITY_OR_OTHER_LEGACY|||||||0.48||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.001667 is considered significant (30 comparisons).|Mixed Models Analysis|||||||0.48
72433171|NCT00938340|144379297|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.001667 is considered significant (30 comparisons).|Mixed Models Analysis|||||||<0.0001
72433172|NCT00938340|144379297|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0003||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.001667 is considered significant (30 comparisons).|Mixed Models Analysis|||||||0.0003
72433173|NCT00938340|144379297|SUPERIORITY_OR_OTHER_LEGACY|||||||0.57||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.001667 is considered significant (30 comparisons).|Mixed Models Analysis|||||||0.57
72433174|NCT00938340|144379297|SUPERIORITY_OR_OTHER_LEGACY|||||||0.99||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.001667 is considered significant (30 comparisons).|Mixed Models Analysis|||||||0.99
72433175|NCT00938340|144379297|SUPERIORITY_OR_OTHER_LEGACY|||||||0.71||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.001667 is considered significant (30 comparisons).|Mixed Models Analysis|||||||0.71
72433176|NCT00938340|144379297|SUPERIORITY_OR_OTHER_LEGACY|||||||0.62||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.001667 is considered significant (30 comparisons).|Mixed Models Analysis|||||||0.62
72433177|NCT00938340|144379297|SUPERIORITY_OR_OTHER_LEGACY|||||||0.33||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.001667 is considered significant (30 comparisons).|Mixed Models Analysis|||||||0.33
72433178|NCT00938340|144379297|SUPERIORITY_OR_OTHER_LEGACY|||||||0.65||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.001667 is considered significant (30 comparisons).|Mixed Models Analysis|||||||0.65
72433179|NCT00938340|144379297|SUPERIORITY_OR_OTHER_LEGACY|||||||0.66||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.001667 is considered significant (30 comparisons).|Mixed Models Analysis|||||||0.66
72493673|NCT01844986|144516510|SUPERIORITY||Hazard Ratio (HR)|0.77|||||TWO_SIDED|95.0|0.29|2.28||Not applicable, due to small sample size. China cohort designed to provide descriptive analysis only.|Regression, Cox|Model includes the stratification variable of response to first-line platinum chemotherapy as a covariate.|A hazard ratio \< 1 favours olaparib|||2.28|0.29|
72493674|NCT01844986|144516511|SUPERIORITY||Hazard Ratio (HR)|0.3|||<|0.0001|TWO_SIDED|95.0|0.23|0.4||Determined using a log-rank test stratified by response to previous platinum chemotherapy|Regression, Cox|Model includes a factor for response to previous platinum chemotherapy|A hazard ratio \< 1 favours olaparib|||0.40|0.23|<0.0001
72493675|NCT01844986|144516511|SUPERIORITY||Hazard Ratio (HR)|0.47|||||TWO_SIDED|95.0|0.23|0.99||Not applicable due to small sample size. China cohort designed to provide descriptive analysis only.|Regression, Cox|Model includes the stratification variable of response to first-line platinum chemotherapy as a covariate.|A hazard ratio \<1 favours Olaparib.|||0.99|0.23|
72493676|NCT01844986|144516512|SUPERIORITY||Hazard Ratio (HR)|0.5||||0.0002|TWO_SIDED|95.0|0.35|0.72||Determined using a log-rank test stratified by response to previous platinum chemotherapy|Regression, Cox|Model includes a factor for response to previous platinum chemotherapy|A hazard ratio \< 1 favours olaparib|||0.72|0.35|0.0002
72493677|NCT01844986|144516512|SUPERIORITY||Hazard Ratio (HR)|0.55|||||TWO_SIDED|95.0|0.23|1.35||Not applicable, due to small sample size. China cohort designed to provide descriptive analysis only.|Regression, Cox|Model includes the stratification variable of response to first-line platinum chemotherapy as a covariate.|A hazard ratio \<1 favours Olaparib.|||1.35|0.23|
72493678|NCT01844986|144516513|SUPERIORITY||Mean Difference (Final Values)|-3.0||||0.001|TWO_SIDED|95.0|-4.779|-1.216|||Mixed Models Analysis|Fixed effects for treatment, visit and baseline TOI with the treatment by visit and baseline TOI by visit interaction. Random patient effect.||||-1.216|-4.779|0.0010
72433180|NCT00938340|144379297|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.001667 is considered significant (30 comparisons).|Mixed Models Analysis|||||||0.30
72433181|NCT00938340|144379297|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0005||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.001667 is considered significant (30 comparisons).|Mixed Models Analysis|||||||0.0005
72433182|NCT00938340|144379297|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0085||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.001667 is considered significant (30 comparisons).|Mixed Models Analysis|||||||0.0085
72433183|NCT00938340|144379297|SUPERIORITY_OR_OTHER_LEGACY|||||||0.92||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.001667 is considered significant (30 comparisons).|Mixed Models Analysis|||||||0.92
72433184|NCT02534896|144379298|SUPERIORITY|||||||0.018|||||||Hochberg and Gatekeeping|||||||0.018
72433185|NCT02534896|144379298|SUPERIORITY|||||||0.007|||||||Hochberg and Gatekeeping|||||||0.007
72433186|NCT02534896|144379299|SUPERIORITY|||||||0.028|||||||Hochberg and Gatekeeping|||||||0.028
72493679|NCT01844986|144516514|SUPERIORITY||Hazard Ratio (HR)|0.3|||<|0.0001|TWO_SIDED|95.0|0.22|0.4||Determined using a log-rank test stratified by response to previous platinum chemotherapy|Regression, Cox|Model includes a factor for response to previous platinum chemotherapy|A hazard ratio \< 1 favours olaparib|||0.40|0.22|<0.0001
72493680|NCT01844986|144516514|SUPERIORITY||Hazard Ratio (HR)|0.58|||||TWO_SIDED|95.0|0.29|1.23||Not applicable, due to small sample size. China cohort designed to provide descriptive analysis only.|Regression, Cox|Model includes the stratification variable of response to first-line platinum chemotherapy as a covariate.|A hazard ratio \<1 favours Olaparib.|||1.23|0.29|
72373891|NCT00955201|144258609|SUPERIORITY|||||||0.94||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time||||0.94
72493681|NCT01844986|144516515|SUPERIORITY||Hazard Ratio (HR)|0.45|||<|0.0001|TWO_SIDED|95.0|0.32|0.63||Determined using a log-rank test stratified by response to previous platinum chemotherapy|Regression, Cox|Model includes a factor for response to previous platinum chemotherapy|A hazard ratio \< 1 favours olaparib|||0.63|0.32|<0.0001
72555365|NCT00950989|144642301|SUPERIORITY||Difference in response rate|3.2||||0.635|TWO_SIDED|95.0|-9.0|15.4||P-value is nominal p-value without multiplicity adjustment based on Cochran-Mantel-Haenszel test adjusting for sex.|Cochran-Mantel-Haenszel|||||15.4|-9.0|0.635
72373892|NCT00955201|144258609|SUPERIORITY|||||||0.69||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time||||0.69
72373893|NCT00955201|144258609|SUPERIORITY|||||||0.98||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time||||0.98
72373894|NCT00955201|144258609|SUPERIORITY|||||||0.97||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time||||0.97
72433187|NCT02534896|144379299|SUPERIORITY|||||||0.003|||||||Hochberg and Gatekeeping|||||||0.003
72433188|NCT02534896|144379300|SUPERIORITY|||||||0.96|||||||Hochberg and Gatekeeping|||||||0.960
72433189|NCT02534896|144379300|SUPERIORITY|||||||0.339|||||||Hochberg and Gatekeeping|||||||0.339
72433190|NCT02534896|144379301|SUPERIORITY|||||||0.573|||||||Hochberg and Gatekeeping|||||||0.573
72433191|NCT02534896|144379301|SUPERIORITY|||||||0.374|||||||Hochberg and Gatekeeping|||||||0.374
72433192|NCT02796092|144379302|SUPERIORITY_OR_OTHER||||||>|0.999|||||||Fisher Exact|||Assuming that both methods were equally effective, we did not use this primary outcome to calculate sample size. It was determined using our own retrospective data of patients from the year 2013, comparing the means of the procedure total time with both methods (41.20±4.66 vs 34.99±4.43 minutes). Ten patients in each group were considered enough to detect the above-mentioned differences with a α-error of 0.05 and 80% power, using a two-sided test.||||>0.999
72373895|NCT00955201|144258609|SUPERIORITY|||||||0.45|||||||ANOVA|||Comparison across groups at baseline||||0.45
72373896|NCT00955201|144258609|SUPERIORITY|||||||0.91|||||||ANOVA|||Comparison across groups at 12-wks||||0.91
72373897|NCT00955201|144258609|SUPERIORITY|||||||0.51|||||||ANOVA|||Comparison across groups at 24-wks||||0.51
72373898|NCT00955201|144258610|SUPERIORITY|||||||0.99||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time||||0.99
72373899|NCT00955201|144258610|SUPERIORITY|||||||0.72||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time||||0.72
72373900|NCT00955201|144258610|SUPERIORITY|||||||0.99||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time||||0.99
72493682|NCT01844986|144516515|SUPERIORITY||Hazard Ratio (HR)|0.55|||||TWO_SIDED|95.0|0.25|1.26||Not applicable, due to small sample size. China cohort designed to provide descriptive analysis only.|Regression, Cox|Model includes the stratification variable of response to first-line platinum chemotherapy as a covariate.|A hazard ratio \<1 favours Olaparib.|||1.26|0.25|
72493683|NCT01844986|144516516|SUPERIORITY||Hazard Ratio (HR)|0.63|||<|0.0001|TWO_SIDED|95.0|0.51|0.79||Determined using a log-rank test stratified by response to previous platinum chemotherapy|Regression, Cox|Model includes a factor for response to previous platinum chemotherapy|A hazard ratio \< 1 favours olaparib|||0.79|0.51|<0.0001
72493684|NCT01844986|144516516|SUPERIORITY||Hazard Ratio (HR)|0.81|||||TWO_SIDED|95.0|0.47|1.42||Not applicable, due to small sample size. China cohort designed to provide descriptive analysis only.|Regression, Cox|Model includes the stratification variable of response to first-line platinum chemotherapy as a covariate.|A hazard ratio \<1 favours Olaparib.|||1.42|0.47|
72433193|NCT02796092|144379303|SUPERIORITY_OR_OTHER|||||||0.3|||||||Fisher Exact|||||||0.3
72433194|NCT02796092|144379304|SUPERIORITY_OR_OTHER||||||>|0.999|||||||Fisher Exact|||||||>0.999
72433195|NCT02796092|144379305|SUPERIORITY_OR_OTHER||||||>|0.999|||||||Fisher Exact|||||||>0.999
72433196|NCT02796092|144379306|SUPERIORITY_OR_OTHER|||||||0.061|||||||Wilcoxon (Mann-Whitney)|||||||0.061
72373901|NCT00955201|144258610|SUPERIORITY|||||||0.99||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time||||0.99
72373902|NCT00955201|144258610|SUPERIORITY|||||||0.85|||||||ANOVA|||Comparison across groups at baseline||||0.85
72373903|NCT00955201|144258610|SUPERIORITY|||||||0.98|||||||ANOVA|||Comparison across groups at 12-wks||||0.98
72373904|NCT00955201|144258610|SUPERIORITY|||||||0.68|||||||ANOVA|||Comparison across groups at 24-wks||||0.68
72373905|NCT00955201|144258611|SUPERIORITY|||||||0.91||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time||||0.91
72433197|NCT02796092|144379307|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
72433198|NCT02796092|144379308|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
72433199|NCT02796092|144379309|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
72433200|NCT02796092|144379310|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
72493685|NCT01844986|144516517|SUPERIORITY||Hazard Ratio (HR)|0.3|||<|0.0001|TWO_SIDED|95.0|0.22|0.4||Determined using a log-rank test stratified by response to previous platinum chemotherapy|Regression, Cox|Model includes a factor for response to previous platinum chemotherapy|A hazard ratio \< 1 favours olaparib|||0.40|0.22|<0.0001
72493686|NCT01449708|144516536|SUPERIORITY_OR_OTHER||Relative Risk|1.27||||0.04|TWO_SIDED|95.0|1.01|1.61|||Chi-squared|||||1.61|1.01|0.04
72493687|NCT01449708|144516538|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.04||||0.009|TWO_SIDED|95.0|1.28|7.29|||Chi-squared|||Grouping of surgical procedures into three categories, analysis using bonferroni correction, 1) ReY group( gastric bypass, conversion to gastric bypass and revision gastric bypass) 2) Gastric Band (GB), 3) sleeve gastrectomy (SG)||7.29|1.28|0.009
72493688|NCT05022641|144516539|SUPERIORITY|||||||0.6|||||||t-test, 2 sided|||||||.6
72493689|NCT05022641|144516540|SUPERIORITY|||||||0.65|||||||t-test, 2 sided|||||||.65
72493690|NCT05022641|144516541|SUPERIORITY|||||||0.02|||||||Chi-squared|||||||.02
72373906|NCT00955201|144258611|SUPERIORITY|||||||0.99||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time||||0.99
72373907|NCT00955201|144258611|SUPERIORITY|||||||0.94||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time||||0.94
72373908|NCT00955201|144258611|SUPERIORITY|||||||0.93||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time||||0.93
72373909|NCT00955201|144258611|SUPERIORITY|||||||0.38|||||||ANOVA|||Comparison across groups at baseline||||0.38
72373910|NCT00955201|144258611|SUPERIORITY|||||||0.51|||||||ANOVA|||Comparison across groups at 12-wks||||0.51
72373911|NCT00955201|144258611|SUPERIORITY|||||||0.94|||||||ANOVA|||Comparison across groups at 24-wks||||0.94
72373912|NCT00955201|144258612|SUPERIORITY|||||||0.99||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time||||0.99
72373913|NCT00955201|144258612|SUPERIORITY|||||||0.97||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time.||||0.97
72373914|NCT00955201|144258612|SUPERIORITY|||||||0.96||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time.||||0.96
72373915|NCT00955201|144258612|SUPERIORITY|||||||1||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time.||||1.00
72373916|NCT00955201|144258612|SUPERIORITY|||||||0.16|||||||ANOVA|||Comparison across groups at baseline.||||0.16
72373917|NCT00955201|144258612|SUPERIORITY|||||||0.37|||||||ANOVA|||Comparison across groups at 12-wks||||0.37
72373918|NCT00955201|144258612|SUPERIORITY|||||||0.75|||||||ANOVA|||Comparison across groups at 24-wks||||0.75
72373919|NCT00955201|144258613|SUPERIORITY|||||||1||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time.||||1.00
72373920|NCT00955201|144258613|SUPERIORITY|||||||0.99||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time.||||0.99
72373921|NCT00955201|144258613|SUPERIORITY|||||||1||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time.||||1.00
72373922|NCT00955201|144258613|SUPERIORITY|||||||0.81||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time.||||0.81
72373923|NCT00955201|144258613|SUPERIORITY|||||||0.28|||||||ANOVA|||Comparison across groups at baseline||||0.28
72493691|NCT05022641|144516542|SUPERIORITY|||||||0.6|||||||t-test, 2 sided|||||||0.6
72493692|NCT05022641|144516544|SUPERIORITY|||||||0.6|||||||Chi-squared|||||||.6
72373924|NCT00955201|144258613|SUPERIORITY|||||||0.28|||||||ANOVA|||Comparison across groups at 12-wks||||0.28
72373925|NCT00955201|144258613|SUPERIORITY|||||||0.83|||||||ANOVA|||Comparison across groups at 24-wks||||0.83
72373926|NCT00955201|144258614|SUPERIORITY|||||||0.99||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time||||0.99
72373927|NCT00955201|144258614|SUPERIORITY|||||||0.97||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time||||0.97
72373928|NCT00955201|144258614|SUPERIORITY|||||||0.82||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time||||0.82
72373929|NCT00955201|144258614|SUPERIORITY|||||||0.96||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time||||0.96
72373930|NCT00955201|144258614|SUPERIORITY|||||||0.55|||||||ANOVA|||Comparison across groups at baseline.||||0.55
72433201|NCT02796092|144379311|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
72373931|NCT00955201|144258614|SUPERIORITY|||||||0.31|||||||ANOVA|||Comparison across groups at 12-wks||||0.31
72373932|NCT00955201|144258614|SUPERIORITY|||||||0.32|||||||ANOVA|||Comparison across groups at 24-wks||||0.32
72373933|NCT00955201|144258615|SUPERIORITY|||||||0.81||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time.||||0.81
72373934|NCT00955201|144258615|SUPERIORITY|||||||0.92||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time.||||0.92
72373935|NCT00955201|144258615|SUPERIORITY|||||||0.93||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time.||||0.93
72373936|NCT00955201|144258615|SUPERIORITY|||||||0.99||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time.||||0.99
72373937|NCT00955201|144258615|SUPERIORITY|||||||0.5|||||||ANOVA|||Comparison across groups at baseline.||||0.50
72373938|NCT00955201|144258615|SUPERIORITY|||||||0.47|||||||ANOVA|||Comparison across groups at 12-wks.||||0.47
72373939|NCT00955201|144258615|SUPERIORITY|||||||0.97|||||||ANOVA|||Comparison across groups at 24-wks||||0.97
72373940|NCT00955201|144258616|SUPERIORITY|||||||0.83||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time.||||0.83
72373941|NCT00955201|144258616|SUPERIORITY|||||||0.91||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time.||||0.91
72373942|NCT00955201|144258616|SUPERIORITY|||||||1||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time.||||1.00
72493693|NCT02889796|144516549|SUPERIORITY||Difference in Response Rates|26.7|||<|0.001|TWO_SIDED|95.0|20.6|32.8||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg vs Placebo at Week 12||32.8|20.6|<0.001
72373943|NCT00955201|144258616|SUPERIORITY|||||||0.95||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time.||||0.95
72373944|NCT00955201|144258616|SUPERIORITY|||||||0.26|||||||ANOVA|||Comparison across groups at baseline.||||0.26
72373945|NCT00955201|144258616|SUPERIORITY|||||||0.42|||||||ANOVA|||Comparison across groups at 12-wks||||0.42
72373946|NCT00955201|144258616|SUPERIORITY|||||||0.95|||||||ANOVA|||Comparison across groups at 24-wks.||||0.95
72373947|NCT00955201|144258617|SUPERIORITY|||||||0.96||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time.||||0.96
72373948|NCT00955201|144258617|SUPERIORITY|||||||0.53||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time.||||0.53
72373949|NCT00955201|144258617|SUPERIORITY|||||||0.79||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time.||||0.79
72373950|NCT00955201|144258617|SUPERIORITY|||||||0.94||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time.||||0.94
72373951|NCT00955201|144258617|SUPERIORITY|||||||0.75|||||||ANOVA|||Comparison across groups at baseline||||0.75
72373952|NCT00955201|144258617|SUPERIORITY|||||||0.51|||||||ANOVA|||Comparison across groups at 12-wks||||0.51
72373953|NCT00955201|144258617|SUPERIORITY|||||||0.63|||||||ANOVA|||Comparison across groups at 24-wks.||||0.63
72373954|NCT00955201|144258618|SUPERIORITY|||||||0.98||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time.||||0.98
72373955|NCT00955201|144258618|SUPERIORITY|||||||0.99||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time.||||0.99
72373956|NCT00955201|144258618|SUPERIORITY|||||||0.89||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time.||||0.89
72373957|NCT00955201|144258618|SUPERIORITY|||||||0.9||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time.||||0.90
72373958|NCT00955201|144258618|SUPERIORITY|||||||0.98|||||||ANOVA|||Comparison across groups at baseline||||0.98
72373959|NCT00955201|144258618|SUPERIORITY|||||||0.94|||||||ANOVA|||Comparison across groups at 12-wks||||0.94
72373960|NCT00955201|144258618|SUPERIORITY|||||||0.91|||||||ANOVA|||Comparison across groups at 24-wks.||||0.91
72373961|NCT00955201|144258619|SUPERIORITY|||||||0.98||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time.||||0.98
72373962|NCT00955201|144258619|SUPERIORITY|||||||0.99||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time.||||0.99
72433202|NCT02796092|144379312|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
72433203|NCT02796092|144379313|SUPERIORITY_OR_OTHER|||||||0.0499|||||||Chi-squared|||||||0.0499
72433204|NCT02796092|144379315|SUPERIORITY_OR_OTHER|||||||0.095|||||||Fisher Exact|||||||0.095
72433205|NCT01107626|144379318|SUPERIORITY|||||||0.12|||||||Log Rank|Stratified logrank test||||||0.12
72433206|NCT01107626|144379318|SUPERIORITY|||||||0.28|||||||Log Rank|Stratified logrank test||||||0.28
72433207|NCT04310579|144379339|SUPERIORITY||Mean Difference (Final Values)|-2.2||||0.22|ONE_SIDED|95.0||2.5||To demonstrate an effect of oxycodone with midazolam compared to oxycodone alone, it is necessary that the upper bound of the one-sided 95% confidence interval (CI) in the least-square mean VE55 difference between treatments \< 0 L/min.|Mixed Models Analysis|The Kenward-Roger approximation will be used to estimate denominator degrees of freedom for tests of fixed effects.|Comparison was the effect of oxycodone with midazolam compared to oxycodone alone.|Part 1 is powered with consideration to both the effect of oxycodone versus placebo and oxycodone plus midazolam versus oxycodone. Assuming a -4 L/min effect size on VE55 and standard deviation of 5 L/min, there is greater than 90% power at a one-sided 0.05 significance level for a sample size of 20 subjects.||2.5||0.22
72433208|NCT04310579|144379340|SUPERIORITY||Mean Difference (Final Values)|-4.9||||0.01|ONE_SIDED|97.5||-0.6||To demonstrate an effect of oxycodone with paroxetine compared to oxycodone alone, it is necessary that the upper bound of the one-sided 97.5% confidence interval (CI) in the least-square mean VE55 difference between treatments \< 0 L/min.|Mixed Models Analysis|The Kenward-Roger approximation will be used to estimate denominator degrees of freedom for tests of fixed effects.|Comparison was the effect of oxycodone and paroxetine compared to oxycodone and placebo.|Sample size and power were calculated based on 2 primary outcomes (day 1 and day 5) with adjustment for multiplicity (α=.025). The assessments with paroxetine or quetiapine were considered as separate experiments. A sample size of 20 participants was determined to have 90 percent power at a 1-sided significance level to detect a 4 L/min decrease in the primary end point (ventilation at 55 mmHg end-tidal carbon dioxide) assuming a standard deviation of 5 L/min.||-0.6||0.01
72433209|NCT04310579|144379340|SUPERIORITY||Mean Difference (Final Values)|-1.2||||0.28|ONE_SIDED|97.5||2.8||To demonstrate an effect of oxycodone with quetiapine compared to oxycodone alone, it is necessary that the upper bound of the one-sided 97.5% confidence interval (CI) in the least-square mean VE55 difference between treatments \< 0 L/min.|Mixed Models Analysis|The Kenward-Roger approximation will be used to estimate denominator degrees of freedom for tests of fixed effects.|Comparison was the effect of oxycodone and quetiapine compared to oxycodone and placebo.|Sample size and power were calculated based on 2 primary outcomes (day 1 and day 5) with adjustment for multiplicity (α=.025). The assessments with paroxetine or quetiapine were considered as separate experiments. A sample size of 20 participants was determined to have 90 percent power at a 1-sided significance level to detect a 4 L/min decrease in the primary end point (ventilation at 55 mmHg end-tidal carbon dioxide) assuming a standard deviation of 5 L/min.||2.8||0.28
72433210|NCT04310579|144379341|SUPERIORITY||Mean Difference (Final Values)|-10.2|||<|0.001|ONE_SIDED|97.5||-6.3||To demonstrate an effect of oxycodone with paroxetine compared to oxycodone alone, it is necessary that the upper bound of the one-sided 97.5% confidence interval (CI) in the least-square mean VE55 difference between treatments \< 0 L/min.|Mixed Models Analysis|The Kenward-Roger approximation will be used to estimate denominator degrees of freedom for tests of fixed effects.|Comparison was the effect of oxycodone and paroxetine compared to oxycodone and placebo.|Sample size and power were calculated based on 2 primary outcomes (day 1 and day 5) with adjustment for multiplicity (α=.025). The assessments with paroxetine or quetiapine were considered as separate experiments. A sample size of 20 participants was determined to have 90 percent power at a 1-sided significance level to detect a 4 L/min decrease in the primary end point (ventilation at 55 mmHg end-tidal carbon dioxide) assuming a standard deviation of 5 L/min.||-6.3||<0.001
72433211|NCT04310579|144379341|SUPERIORITY||Mean Difference (Final Values)|-0.6||||0.37|ONE_SIDED|97.5||3.2||To demonstrate an effect of oxycodone with quetiapine compared to oxycodone alone, it is necessary that the upper bound of the one-sided 97.5% confidence interval (CI) in the least-square mean VE55 difference between treatments \< 0 L/min.|Mixed Models Analysis|The Kenward-Roger approximation will be used to estimate denominator degrees of freedom for tests of fixed effects.|Comparison was the effect of oxycodone and quetiapine compared to oxycodone and placebo.|Sample size and power were calculated based on 2 primary outcomes (day 1 and day 5) with adjustment for multiplicity (α=.025). The assessments with paroxetine or quetiapine were considered as separate experiments. A sample size of 20 participants was determined to have 90 percent power at a 1-sided significance level to detect a 4 L/min decrease in the primary end point (ventilation at 55 mmHg end-tidal carbon dioxide) assuming a standard deviation of 5 L/min.||3.2||0.37
72433212|NCT04310579|144379342|SUPERIORITY||Mean Difference (Final Values)|-6.8||||0.005|ONE_SIDED|95.0||-2.5||Secondary analyses are not adjusted for multiplicity. To demonstrate an effect of oxycodone compared to placebo, it is necessary that the upper bound of the one-sided 95% CI in the least-square mean VE55 difference between treatments \< 0 L/min.|Mixed Models Analysis|The Kenward-Roger approximation will be used to estimate denominator degrees of freedom for tests of fixed effects.|Comparison was the effect of oxycodone compared to placebo.|Part 1 is powered with consideration to both the effect of oxycodone versus placebo and oxycodone plus midazolam versus oxycodone. Assuming a -4 L/min effect size on VE55 and standard deviation of 5 L/min, there is greater than 90% power at a one-sided 0.05 significance level for a sample size of 20 subjects.||-2.5||0.005
72433213|NCT04310579|144379342|SUPERIORITY||Mean Difference (Final Values)|-0.9||||0.37|ONE_SIDED|95.0||3.7||Secondary analyses are not adjusted for multiplicity. To demonstrate an effect of midazolam compared to placebo, it is necessary that the upper bound of the one-sided 95% CI in the least-square mean VE55 difference between treatments \< 0 L/min.|Mixed Models Analysis|The Kenward-Roger approximation will be used to estimate denominator degrees of freedom for tests of fixed effects.|Comparison was the effect of midazolam compared to placebo.|Part 1 is powered with consideration to both the effect of oxycodone versus placebo and oxycodone plus midazolam versus oxycodone. Assuming a -4 L/min effect size on VE55 and standard deviation of 5 L/min, there is greater than 90% power at a one-sided 0.05 significance level for a sample size of 20 subjects.||3.7||0.37
72433214|NCT04310579|144379343|SUPERIORITY||Mean Difference (Final Values)|-9.3|||<|0.001|ONE_SIDED|97.5||-3.9||Secondary analyses are not adjusted for multiplicity. To demonstrate an effect of paroxetine compared to placebo, it is necessary that the upper bound of the one-sided 97.5% CI in the least-square mean VE55 difference between treatments \< 0 L/min.|Mixed Models Analysis|The Kenward-Roger approximation will be used to estimate denominator degrees of freedom for tests of fixed effects.|Comparison was the effect of paroxetine compared to placebo.|Sample size and power were calculated based on 2 primary outcomes (day 1 and day 5) with adjustment for multiplicity (α=.025). The assessments with paroxetine or quetiapine were considered as separate experiments. A sample size of 20 participants was determined to have 90 percent power at a 1-sided significance level to detect a 4 L/min decrease in the primary end point (ventilation at 55 mmHg end-tidal carbon dioxide) assuming a standard deviation of 5 L/min.||-3.9||<0.001
72493694|NCT02889796|144516549|SUPERIORITY||Difference in Response Rates|19.9|||<|0.001|TWO_SIDED|95.0|13.6|26.2||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg vs Placebo at Week 12||26.2|13.6|<0.001
72504448|NCT03726671|144539458|OTHER|||||||0.0187|||||||Mixed Models Analysis|The model evaluates effects from SNP, diet and SNP x diet interaction. Due to crossover design, period and sequence effects were adjusted in the model||SNP effect on Phosphatidylcholine IER in Post-Menopausal Females||||0.0187
72373963|NCT00955201|144258619|SUPERIORITY|||||||0.84||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time.||||0.84
72373964|NCT00955201|144258619|SUPERIORITY|||||||1||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time.||||1.00
72373965|NCT00955201|144258619|SUPERIORITY|||||||0.96|||||||ANOVA|||Comparison across groups at baseline.||||0.96
72373966|NCT00955201|144258619|SUPERIORITY|||||||0.86|||||||ANOVA|||Comparison across groups at 12-wks.||||0.86
72373967|NCT00955201|144258619|SUPERIORITY|||||||0.92|||||||ANOVA|||Comparison across groups at 24-wks.||||0.92
72373968|NCT00955201|144258620|SUPERIORITY|||||||0.03||||||Unpaired two-tailed t-test:|t-test, 2 sided|||Evaluate within group pre- and post-test responses across time.||||0.03
72373969|NCT00955201|144258620|SUPERIORITY|||||||0.29||||||Unpaired two-tailed t-test:|t-test, 2 sided|||Evaluate within group pre- and post-test responses across time.||||0.29
72373970|NCT00955201|144258620|SUPERIORITY|||||||0.36||||||Unpaired two-tailed t-test:|t-test, 2 sided|||Evaluate within group pre- and post-test responses across time.||||0.36
72433215|NCT04310579|144379343|SUPERIORITY||Mean Difference (Final Values)|1.1||||0.67|ONE_SIDED|97.5||6.4||Secondary analyses are not adjusted for multiplicity. To demonstrate an effect of quetiapine compared to placebo, it is necessary that the upper bound of the one-sided 97.5% CI in the least-square mean VE55 difference between treatments \< 0 L/min.|Mixed Models Analysis|The Kenward-Roger approximation will be used to estimate denominator degrees of freedom for tests of fixed effects.|Comparison was the effect of quetiapine compared to placebo.|Sample size and power were calculated based on 2 primary outcomes (day 1 and day 5) with adjustment for multiplicity (α=.025). The assessments with paroxetine or quetiapine were considered as separate experiments. A sample size of 20 participants was determined to have 90 percent power at a 1-sided significance level to detect a 4 L/min decrease in the primary end point (ventilation at 55 mmHg end-tidal carbon dioxide) assuming a standard deviation of 5 L/min.||6.4||0.67
72373971|NCT00955201|144258620|SUPERIORITY|||||||0.15||||||Unpaired two-tailed t-test:|t-test, 2 sided|||Evaluate within group pre- and post-test responses across time.||||0.15
72373972|NCT00955201|144258620|SUPERIORITY|||||||0.2||||||ANOVA|ANOVA|||Comparison of pre- and post-responses across groups at baseline.||||0.20
72373973|NCT00955201|144258620|SUPERIORITY|||||||0.51||||||ANOVA|ANOVA|||Comparison of pre- and post-test responses across groups at 12 wks.||||0.51
72373974|NCT00955201|144258620|SUPERIORITY|||||||0.59||||||ANOVA|ANOVA|||Comparison of pre- and post-test responses across groups at 24 wks.||||0.59
72373975|NCT00955201|144258621|SUPERIORITY|||||||1||||||Dunn's multiple comparisons|Kruskal-Wallis|||Evaluate within group across time||||1.00
72373976|NCT00955201|144258621|SUPERIORITY|||||||0.01||||||Dunn's multiple comparisons|Kruskal-Wallis|||Evaluate within group across time||||0.01
72373977|NCT00955201|144258621|SUPERIORITY|||||||1||||||Dunn's multiple comparisons|Kruskal-Wallis|||Evaluate within group across time||||1.00
72373978|NCT00955201|144258621|SUPERIORITY|||||||0.98||||||Dunn's multiple comparisons|Kruskal-Wallis|||Evaluate within group across time||||0.98
72373979|NCT00955201|144258621|SUPERIORITY|||||||0.96|||||||Kruskal-Wallis|||Comparison across groups at baseline||||0.96
72373980|NCT00955201|144258621|SUPERIORITY|||||||0.06|||||||Kruskal-Wallis|||Comparison across groups at 12-wks||||0.06
72373981|NCT00955201|144258621|SUPERIORITY|||||||0.14|||||||Kruskal-Wallis|||Comparison across groups at 24-wks||||0.14
72373982|NCT00955201|144258622|SUPERIORITY|||||||1||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time.||||1.00
72373983|NCT00955201|144258622|SUPERIORITY|||||||0.36||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time.||||0.36
72373984|NCT00955201|144258622|SUPERIORITY|||||||0.93||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time.||||0.93
72373985|NCT00955201|144258622|SUPERIORITY|||||||0.46||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time.||||0.46
72373986|NCT00955201|144258622|SUPERIORITY|||||||0.14|||||||ANOVA|||Comparison across groups at baseline.||||0.14
72373987|NCT00955201|144258622|SUPERIORITY|||||||0.05|||||||ANOVA|||Comparison across groups at 12 wks.||||0.05
72373988|NCT00955201|144258622|SUPERIORITY|||||||0.01|||||||ANOVA|||Comparison across groups at 24 wks.||||0.01
72373989|NCT00955201|144258623|SUPERIORITY|||||||0.98||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time.||||0.98
72373990|NCT00955201|144258623|SUPERIORITY|||||||0.98||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time.||||0.98
72373991|NCT00955201|144258623|SUPERIORITY|||||||0.67||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time.||||0.67
72373992|NCT00955201|144258623|SUPERIORITY|||||||0.55||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time.||||0.55
72373993|NCT00955201|144258623|SUPERIORITY|||||||0.4||||||Tukey's multiple comparisons test:|ANOVA|||Comparison across groups at baseline.||||0.40
72373994|NCT00955201|144258623|SUPERIORITY|||||||0.47|||||||ANOVA|||Comparison across groups at 12 wks.||||0.47
72373995|NCT00955201|144258623|SUPERIORITY|||||||0.43|||||||ANOVA|||Comparison across groups at 24 wks.||||0.43
72373996|NCT00955201|144258624|SUPERIORITY|||||||0.84||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time.||||0.84
72373997|NCT00955201|144258624|SUPERIORITY|||||||0.93||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time.||||0.93
72373998|NCT00955201|144258624|SUPERIORITY|||||||0.94||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time.||||0.94
72373999|NCT00955201|144258624|SUPERIORITY|||||||0.94||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time.||||0.94
72374000|NCT00955201|144258624|SUPERIORITY|||||||0.88|||||||ANOVA|||Comparison across groups at baseline.||||0.88
72374001|NCT00955201|144258624|SUPERIORITY|||||||0.48|||||||ANOVA|||Comparison across groups at 12 wks.||||0.48
72374002|NCT00955201|144258624|SUPERIORITY|||||||0.38|||||||ANOVA|||Comparison across groups at 24 wks.||||0.38
72374003|NCT00955201|144258625|SUPERIORITY|||||||0.87||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time.||||0.87
72374004|NCT00955201|144258625|SUPERIORITY|||||||0.93||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time.||||0.93
72433216|NCT04310579|144379345|EQUIVALENCE|A difference in exposure was concluded if the 2-sided 90% CI of the geometric mean ratio excluded 1, which is standard in pharmacokinetic studies|Geometric mean ratio|1.06||||0.33|TWO_SIDED|90.0|0.96|1.17||Secondary analyses are not adjusted for multiplicity.|Mixed Models Analysis||Comparison was the effect of oxycodone and paroxetine compared to oxycodone and placebo.|Maximum oxycodone concentration was log-transformed and the values between study treatments were compared using a linear mixed effects model on day 1 with treatment as a categorical variable and participant as a random effect||1.17|0.96|0.33
72433217|NCT04310579|144379345|EQUIVALENCE|A difference in exposure was concluded if the 2-sided 90% CI of the geometric mean ratio excluded 1, which is standard in pharmacokinetic studies|Geometric mean ratio|1.25|||<|0.001|TWO_SIDED|90.0|1.14|1.37||Secondary analyses are not adjusted for multiplicity.|Mixed Models Analysis||Comparison was the effect of oxycodone and quetiapine compared to oxycodone and placebo.|Maximum oxycodone concentration was log-transformed and the values between study treatments were compared using a linear mixed effects model on day 1 with treatment as a categorical variable and participant as a random effect||1.37|1.14|<0.001
72433218|NCT04310579|144379346|EQUIVALENCE|A difference in exposure was concluded if the 2-sided 90% CI of the geometric mean ratio excluded 1, which is standard in pharmacokinetic studies|Geometric mean ratio|1.3|||<|0.001|TWO_SIDED|90.0|1.19|1.43||Secondary analyses are not adjusted for multiplicity.|Mixed Models Analysis||Comparison was the effect of oxycodone and paroxetine compared to oxycodone and placebo.|Maximum oxycodone concentration was log-transformed and the values between study treatments were compared using a linear mixed effects model on day 5 with treatment as a categorical variable and participant as a random effect||1.43|1.19|<0.001
72433219|NCT04310579|144379346|EQUIVALENCE|A difference in exposure was concluded if the 2-sided 90% CI of the geometric mean ratio excluded 1, which is standard in pharmacokinetic studies|Geometric mean ratio|1.39|||<|0.001|TWO_SIDED|90.0|1.22|1.57||Secondary analyses are not adjusted for multiplicity.|Mixed Models Analysis||Comparison was the effect of oxycodone and quetiapine compared to oxycodone and placebo.|Maximum oxycodone concentration was log-transformed and the values between study treatments were compared using a linear mixed effects model on day 5 with treatment as a categorical variable and participant as a random effect||1.57|1.22|<0.001
72433220|NCT04310579|144379348|EQUIVALENCE|A difference in exposure was concluded if the 2-sided 90% CI of the geometric mean ratio excluded 1, which is standard in pharmacokinetic studies|Geometric mean ratio|1.03||||0.64|TWO_SIDED|90.0|0.91|1.17||Secondary analyses are not adjusted for multiplicity.|Mixed Models Analysis||Comparison was the effect of oxycodone and paroxetine compared to oxycodone and placebo.|Area under the curve was log-transformed and the values between study treatments were compared using a linear mixed effects model on day 1 with treatment as a categorical variable and participant as a random effect||1.17|0.91|0.64
72433221|NCT04310579|144379348|EQUIVALENCE|A difference in exposure was concluded if the 2-sided 90% CI of the geometric mean ratio excluded 1, which is standard in pharmacokinetic studies|Geometric mean ratio|1.06||||0.24|TWO_SIDED|90.0|0.98|1.15||Secondary analyses are not adjusted for multiplicity.|Mixed Models Analysis||Comparison was the effect of oxycodone and quetiapine compared to oxycodone and placebo.|Area under the curve was log-transformed and the values between study treatments were compared using a linear mixed effects model on day 1 with treatment as a categorical variable and participant as a random effect||1.15|0.98|0.24
72433222|NCT04310579|144379349|EQUIVALENCE|A difference in exposure was concluded if the 2-sided 90% CI of the geometric mean ratio excluded 1, which is standard in pharmacokinetic studies|Geometric mean ratio|1.1||||0.05|TWO_SIDED|90.0|1.02|1.19||Secondary analyses are not adjusted for multiplicity.|Mixed Models Analysis||Comparison was the effect of oxycodone and paroxetine compared to oxycodone and placebo.|Area under the curve was log-transformed and the values between study treatments were compared using a linear mixed effects model on day 5 with treatment as a categorical variable and participant as a random effect||1.19|1.02|0.05
72433223|NCT04310579|144379349|EQUIVALENCE|A difference in exposure was concluded if the 2-sided 90% CI of the geometric mean ratio excluded 1, which is standard in pharmacokinetic studies|Geometric mean ratio|1.27|||<|0.001|TWO_SIDED|90.0|1.19|1.36||Secondary analyses are not adjusted for multiplicity.|Mixed Models Analysis||Comparison was the effect of oxycodone and quetiapine compared to oxycodone and placebo.|Area under the curve was log-transformed and the values between study treatments were compared using a linear mixed effects model on day 5 with treatment as a categorical variable and participant as a random effect||1.36|1.19|<0.001
72433224|NCT03710564|144379358|SUPERIORITY||Least Squares Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.76||0.4537|TWO_SIDED|95.0|-2.1|0.9|||Pairwise ANOVA|||||0.9|-2.1|0.4537
72433225|NCT03006341|144379379|OTHER||C-Statistic|0.81|||||||||||Regression, Logistic|Logistic regression with bleeding history or predisposition as dependent and treatment groups and claims based variables as the independent variables|The C-statistic can be between 0.5 and 1 and a value of 0.5 indicates that the model is no better than chance at making a prediction and a value of 1.0 indicates that the model perfectly identifies those within a group and those not.|"The concordance statistic is equal to the area under a receiver operating characteristic (ROC) curve. The C-statistic (sometimes called the concordance statistic or C-index) is a measure of goodness of fit for binary outcomes in a logistic regression model."||||
72433226|NCT03006341|144379381|OTHER||Adjusted R squared statistic|0.02|||||||||||Regression, Linear|Logistic regression model with serum creatinine as the dependent variable and treatment groups and claims based variables as the independent variables|The adjusted R² statistic, or coefficient of determination, is the proportion of the variance in the (EMR) outcome that is predictable from the independent (claims) variables, adjusted for the number of predictors in the model.|R-squared is a statistical measure of how close the data are to the fitted regression line. 0% indicates that the model explains none of the variability of the response data around its mean. 100% indicates that the model explains all the variability of the response data around its mean.||||
72433227|NCT03006341|144379383|OTHER||Adjusted R squared statistic|0.04|||||||||||Regression, Linear|Linear regression model with duration of atrial fibrillation as dependent and treatment groups and claims based variables as independent variables|The adjusted R² statistic, or coefficient of determination, is the proportion of the variance in the (EMR) outcome that is predictable from the independent (claims) variables, adjusted for the number of predictors in the model.|R-squared is a statistical measure of how close the data are to the fitted regression line. 0% indicates that the model explains none of the variability of the response data around its mean. 100% indicates that the model explains all the variability of the response data around its mean.||||
72374005|NCT00955201|144258625|SUPERIORITY|||||||0.51||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time.||||0.51
72433228|NCT03006341|144379389|OTHER||C-Statistic|0.88|||||||||||Regression, Logistic|Logistic regression model with diabetes as the dependent variable and treatment groups and claims based variables as the independent variables.|The C-statistic can be between 0.5 and 1 and a value of 0.5 indicates that the model is no better than chance at making a prediction and a value of 1.0 indicates that the model perfectly identifies those within a group and those not.|"The concordance statistic is equal to the area under a ROC curve. The C-statistic (sometimes called the concordance statistic or C-index) is a measure of goodness of fit for binary outcomes in a logistic regression model."||||
72433229|NCT03006341|144379390|OTHER||C-Statistic|0.69|||||||||||Regression, Logistic|Logistic regression model with hyperlipidemia as the dependent variable and treatment groups and claims based variables as the independent variables.|The C-statistic can be between 0.5 and 1 and a value of 0.5 indicates that the model is no better than chance at making a prediction and a value of 1.0 indicates that the model perfectly identifies those within a group and those not.|"The concordance statistic is equal to the area under a ROC curve. The C-statistic (sometimes called the concordance statistic or C-index) is a measure of goodness of fit for binary outcomes in a logistic regression model."||||
72433230|NCT03006341|144379391|OTHER||Adjusted R squared statistic|0.34|||||||||||Regression, Linear|Linear regression model with HAS-BLED score as the dependent variable and treatment groups and claims based variables as the independent variables.|The adjusted R² statistic, or coefficient of determination, is the proportion of the variance in the (EMR) outcome that is predictable from the independent (claims) variables, adjusted for the number of predictors in the model.|R-squared is a statistical measure of how close the data are to the fitted regression line. 0% indicates that the model explains none of the variability of the response data around its mean. 100% indicates that the model explains all the variability of the response data around its mean.||||
72433231|NCT00478556|144379397|SUPERIORITY_OR_OTHER||difference in proportions|62.0|||<|0.001|||||||Binomial test of proportion|tested if values were different from 50%||All individuals tasted both preparations and indicated preference. A binomial test of proportion was done to see if these values differed from 50%.||||<0.001
72433232|NCT00478556|144379398|SUPERIORITY_OR_OTHER|||||||0.27||95.0|||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum test was used to assess differences in bowel opacification score between the two groups.||||0.270
72433233|NCT04807517|144379409|OTHER|Within-group test for 16-week change|||||<|0.001|||||||Regression, Linear|Repeated measures linear regression||||||<0.001
72433234|NCT04927975|144379439|SUPERIORITY|Repeated measures analysis was conducted using a mixed model including observed measurements at all visits. The model included categorical fixed effects of treatment, visit and treatment-by-visit interaction, and stratification factors (age \[≤ 50 and \> 50\], Baseline disease severity \[T-VASI \< 15 and ≥ 15\], active vitiligo \[Yes/No\]) derived from actual values, and the continuous fixed covariate of Baseline measurement. An unstructured variance covariance matrix was used.|LS Mean Difference|-7.6||||0.304|TWO_SIDED|95.0|-22.18|6.97|||Mixed-Effect Model Repeat Measurement|||Upa 6 mg Period 1 versus Placebo Period 1||6.97|-22.18|0.304
72433235|NCT04927975|144379439|SUPERIORITY|Repeated measures analysis was conducted using a mixed model including observed measurements at all visits. The model included categorical fixed effects of treatment, visit and treatment-by-visit interaction, and stratification factors (age \[≤ 50 and \> 50\], Baseline disease severity \[T-VASI \< 15 and ≥ 15\], active vitiligo \[Yes/No\]) derived from actual values, and the continuous fixed covariate of Baseline measurement. An unstructured variance covariance matrix was used.|LS Mean Difference|-21.27||||0.005|TWO_SIDED|95.0|-36.02|-6.52|||Mixed-Effect Model Repeat Measurement|||Upa 11 mg Period 1 versus Placebo Period 1||-6.52|-36.02|0.005
72433236|NCT04927975|144379439|SUPERIORITY|Repeated measures analysis was conducted using a mixed model including observed measurements at all visits. The model included categorical fixed effects of treatment, visit and treatment-by-visit interaction, and stratification factors (age \[≤ 50 and \> 50\], Baseline disease severity \[T-VASI \< 15 and ≥ 15\], active vitiligo \[Yes/No\]) derived from actual values, and the continuous fixed covariate of Baseline measurement. An unstructured variance covariance matrix was used.|LS Mean Difference|-19.6||||0.013|TWO_SIDED|95.0|-35.04|-4.16|||Mixed-Effect Model Repeat Measurement|||Upa 22 mg Period 1 versus Placebo Period 1||-4.16|-35.04|0.013
72433237|NCT04927975|144379440|SUPERIORITY|P-value calculated according to the Cochran-Mantel-Haenszel test adjusted for strata (age group \[≤ 50 and \> 50\], baseline disease severity \[T-VASI \< 15 and ≥ 15\], and status of active vitiligo \[Yes/No\])) for the comparison of two treatment groups. The calculations at each visit were based on non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19 or non-responder imputation only if there were no missing data due to COVID-19.|Response Rate Difference|6.9||||0.1|TWO_SIDED|95.0|-1.3|15.2|||Cochran-Mantel-Haenszel|||Upa 6 mg Period 1 versus Placebo Period 1||15.2|-1.3|0.100
72493695|NCT02889796|144516550|SUPERIORITY||Least Squares Mean Difference|-0.29|STANDARD_ERROR_OF_MEAN|0.034|<|0.001|TWO_SIDED|95.0|-0.36|-0.22||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|Mixed effects model for repeated measure|||Filgotinib 200 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from mixed effects model for repeated measures (MMRM). Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.22|-0.36|<0.001
72374006|NCT00955201|144258625|SUPERIORITY|||||||0.89||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time.||||0.89
72374007|NCT00955201|144258625|SUPERIORITY|||||||0.46|||||||ANOVA|||Comparison across groups at baseline.||||0.46
72374008|NCT00955201|144258625|SUPERIORITY|||||||0.72|||||||ANOVA|||Comparison across groups at 12 wks.||||0.72
72374009|NCT00955201|144258625|SUPERIORITY|||||||0.22|||||||ANOVA|||Comparison across groups at 24wks.||||0.22
72374010|NCT00955201|144258626|SUPERIORITY|||||||0.98||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time.||||0.98
72374011|NCT00955201|144258626|SUPERIORITY|||||||0.99||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time.||||0.99
72374012|NCT00955201|144258626|SUPERIORITY|||||||0.87||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time.||||0.87
72374013|NCT00955201|144258626|SUPERIORITY|||||||0.95||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time.||||0.95
72493696|NCT02889796|144516550|SUPERIORITY||Least Squares Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.034|<|0.001|TWO_SIDED|95.0|-0.24|-0.1||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.10|-0.24|<0.001
72433238|NCT04927975|144379440|SUPERIORITY|P-value calculated according to the Cochran-Mantel-Haenszel test adjusted for strata (age group \[≤ 50 and \> 50\], baseline disease severity \[T-VASI \< 15 and ≥ 15\], and status of active vitiligo \[Yes/No\])) for the comparison of two treatment groups. The calculations at each visit were based on non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19 or non-responder imputation only if there were no missing data due to COVID-19.|Response Rate Difference|17.8||||0.002|TWO_SIDED|95.0|6.5|29.0|||Cochran-Mantel-Haenszel|||Upa 11 mg Period 1 versus Placebo Period 1||29.0|6.5|0.002
72433239|NCT04927975|144379440|SUPERIORITY|P-value calculated according to the Cochran-Mantel-Haenszel test adjusted for strata (age group \[≤ 50 and \> 50\], baseline disease severity \[T-VASI \< 15 and ≥ 15\], and status of active vitiligo \[Yes/No\])) for the comparison of two treatment groups. The calculations at each visit were based on non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19 or non-responder imputation only if there were no missing data due to COVID-19.|Response Rate Difference|11.7||||0.026|TWO_SIDED|95.0|1.4|21.9|||Cochran-Mantel-Haenszel|||Upa 22 mg Period 1 versus Placebo Period 1||21.9|1.4|0.026
72433240|NCT04927975|144379441|SUPERIORITY|P-value calculated according to the Cochran-Mantel-Haenszel test adjusted for strata (age group \[≤ 50 and \> 50\], baseline disease severity \[T-VASI \< 15 and ≥ 15\], and status of active vitiligo \[Yes/No\])) for the comparison of two treatment groups. The calculations at each visit were based on non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19 or non-responder imputation only if there were no missing data due to COVID-19.|Response Rate Difference|6.6||||0.327|TWO_SIDED|95.0|-6.6|19.7|||Cochran-Mantel-Haenszel|||Upa 6 mg Period 1 versus Placebo Period 1||19.7|-6.6|0.327
72433241|NCT04927975|144379441|SUPERIORITY|P-value calculated according to the Cochran-Mantel-Haenszel test adjusted for strata (age group \[≤ 50 and \> 50\], baseline disease severity \[T-VASI \< 15 and ≥ 15\], and status of active vitiligo \[Yes/No\])) for the comparison of two treatment groups. The calculations at each visit were based on non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19 or non-responder imputation only if there were no missing data due to COVID-19.|Response Rate Difference|29.3|||<|0.001|TWO_SIDED|95.0|13.8|44.9|||Cochran-Mantel-Haenszel|||Upa 11 mg Period 1 versus Placebo Period 1||44.9|13.8|<0.001
72433242|NCT04927975|144379441|SUPERIORITY|P-value calculated according to the Cochran-Mantel-Haenszel test adjusted for strata (age group \[≤ 50 and \> 50\], baseline disease severity \[T-VASI \< 15 and ≥ 15\], and status of active vitiligo \[Yes/No\])) for the comparison of two treatment groups. The calculations at each visit were based on non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19 or non-responder imputation only if there were no missing data due to COVID-19.|Response Rate Difference|28.7|||<|0.001|TWO_SIDED|95.0|12.6|44.7|||Cochran-Mantel-Haenszel|||Upa 22 mg Period 1 versus Placebo Period 1||44.7|12.6|<0.001
72433243|NCT04927975|144379442|SUPERIORITY|P-value calculated according to the Cochran-Mantel-Haenszel test adjusted for strata (age group \[≤ 50 and \> 50\], baseline disease severity \[T-VASI \< 15 and ≥ 15\], and status of active vitiligo \[Yes/No\])) for the comparison of two treatment groups. The calculations at each visit were based on non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19 or non-responder imputation only if there were no missing data due to COVID-19.|Response Rate Difference|3.7||||0.34|TWO_SIDED|95.0|-3.9|11.2|||Cochran-Mantel-Haenszel|||Upa 6 mg Period 1 versus Placebo Period 1||11.2|-3.9|0.340
72433244|NCT04927975|144379442|SUPERIORITY|P-value calculated according to the Cochran-Mantel-Haenszel test adjusted for strata (age group \[≤ 50 and \> 50\], baseline disease severity \[T-VASI \< 15 and ≥ 15\], and status of active vitiligo \[Yes/No\])) for the comparison of two treatment groups. The calculations at each visit were based on non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19 or non-responder imputation only if there were no missing data due to COVID-19.|Response Rate Difference|3.8||||0.358|TWO_SIDED|95.0|-4.3|11.8|||Cochran-Mantel-Haenszel|||Upa 11 mg Period 1 versus Placebo Period 1||11.8|-4.3|0.358
72493697|NCT02889796|144516551|SUPERIORITY||Difference in Response Rates|24.8|||<|0.001|TWO_SIDED|95.0|19.6|30.0||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg vs Placebo at Week 12.||30.0|19.6|<0.001
72493698|NCT02889796|144516551|SUPERIORITY||Difference in Response Rates|14.5|||<|0.001|TWO_SIDED|95.0|9.7|19.3||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg vs Placebo at Week 12.||19.3|9.7|<0.001
72493699|NCT02889796|144516551|NON_INFERIORITY|For non-inferiority test, the approach proposed by Liu 2014 was used to demonstrate that each filgotinib dose preserves more than 50% of the effect of adalimumab on the response rate of DAS28 (CRP) \< 2.6 using non-responder imputation (NRI).|||||<|0.001||||||P-value of non-inferiority test was calculated from approach proposed by \[Liu 2014\].|Method proposed by [Liu 2014]|||Filgotinib 200 mg vs Adalimumab at Week 12.||||<0.001
72493700|NCT02889796|144516551|NON_INFERIORITY|For non-inferiority test, the approach proposed by Liu 2014 was used to demonstrate that each filgotinib dose preserves more than 50% of the effect of adalimumab on the response rate of DAS28 (CRP) \< 2.6 using NRI.||||||0.002||||||P-value of non-inferiority test was calculated from approach proposed by \[Liu 2014\].|Method proposed by [Liu 2014]|||Filgotinib 100 mg vs Adalimumab at Week 12.||||0.002
72555366|NCT00950989|144642301|SUPERIORITY|||||||0.74||||||Adjusted p-value is based on a combination of sequential testing and the Hommel procedure to control the overall significance level for all the comparisons.|Sequential testing + Hommel procedure|||||||0.740
72374014|NCT00955201|144258626|SUPERIORITY|||||||0.39|||||||ANOVA|||Comparison across groups at baseline.||||0.39
72374015|NCT00955201|144258626|SUPERIORITY|||||||0.59|||||||ANOVA|||Comparison across groups at 12-wks.||||0.59
72374016|NCT00955201|144258626|SUPERIORITY|||||||0.29|||||||ANOVA|||Comparison across groups at 24-wks.||||0.29
72374017|NCT00955201|144258627|SUPERIORITY|||||||0.97||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time||||0.97
72374018|NCT00955201|144258627|SUPERIORITY|||||||1||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time.||||1.00
72374019|NCT00955201|144258627|SUPERIORITY|||||||0.09||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time.||||0.09
72374020|NCT00955201|144258627|SUPERIORITY|||||||0.05||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time.||||0.05
72493701|NCT02889796|144516551|SUPERIORITY||Difference in Response Rates|10.4||||0.001|TWO_SIDED|95.0|3.9|17.0||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg vs Adalimumab at Week 12.||17.0|3.9|0.001
72374021|NCT00955201|144258627|SUPERIORITY|||||||0.11|||||||ANOVA|||Comparison across groups at baseline.||||0.11
72374022|NCT00955201|144258627|SUPERIORITY|||||||0.41|||||||ANOVA|||Comparison across groups at 12-wks.||||0.41
72374023|NCT00955201|144258627|SUPERIORITY|||||||0.03|||||||ANOVA|||Comparison across groups at 24-wks.||||0.03
72374024|NCT00955201|144258628|SUPERIORITY|||||||0.95||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time.||||0.95
72374025|NCT00955201|144258628|SUPERIORITY|||||||1||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time.||||1.00
72374026|NCT00955201|144258628|SUPERIORITY|||||||0.87||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time.||||0.87
72374027|NCT00955201|144258628|SUPERIORITY|||||||0.48||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time.||||0.48
72374028|NCT00955201|144258628|SUPERIORITY|||||||0.58|||||||ANOVA|||Comparison across groups at baseline.||||0.58
72374029|NCT00955201|144258628|SUPERIORITY|||||||0.5|||||||ANOVA|||Comparison across groups at 12-wks.||||0.50
72374030|NCT00955201|144258628|SUPERIORITY|||||||0.33|||||||ANOVA|||Comparison across groups at 24-wks.||||0.33
72374031|NCT00955201|144258629|SUPERIORITY|||||||0.98||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time.||||0.98
72374032|NCT00955201|144258629|SUPERIORITY|||||||1||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time.||||1.00
72374033|NCT00955201|144258629|SUPERIORITY|||||||0.88||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time.||||0.88
72374034|NCT00955201|144258629|SUPERIORITY|||||||0.93||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time.||||0.93
72374035|NCT00955201|144258629|SUPERIORITY|||||||0.38|||||||ANOVA|||Comparison across groups at baseline.||||0.38
72374036|NCT00955201|144258629|SUPERIORITY|||||||0.55|||||||ANOVA|||Comparison across groups at 12-wks.||||0.55
72374037|NCT00955201|144258629|SUPERIORITY|||||||0.37|||||||ANOVA|||Comparison across groups at 24-wks||||0.37
72374038|NCT00955201|144258630|SUPERIORITY|||||||1||||||Dunn's multiple comparisons test:|Kruskal-Wallis|||Evaluate within group across time||||1.00
72493702|NCT02889796|144516551|SUPERIORITY||Difference in Response Rates|0.1||||0.99|TWO_SIDED|95.0|-6.2|6.3||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg vs Adalimumab at Week 12.||6.3|-6.2|0.99
72504449|NCT03726671|144539458|OTHER|||||||0.0107|||||||Mixed Models Analysis|The model evaluates effects from SNP, diet and SNP x diet interaction. Due to crossover design, period and sequence effects were adjusted in the model||SNP effect on Phosphatidylcholine IER in Males||||0.0107
72504450|NCT03726671|144539459|OTHER|||||||0.0842|||||||Mixed Models Analysis|||||||0.0842
72374039|NCT00955201|144258630|SUPERIORITY|||||||1||||||Dunn's multiple comparisons test:|Kruskal-Wallis|||Evaluate within group across time||||1.00
72374040|NCT00955201|144258630|SUPERIORITY|||||||1||||||Dunn's multiple comparisons test:|Kruskal-Wallis|||Evaluate within group across time||||1.00
72374041|NCT00955201|144258630|SUPERIORITY|||||||1||||||Dunn's multiple comparisons test:|Kruskal-Wallis|||Evaluate within group across time.||||1.00
72374042|NCT00955201|144258630|SUPERIORITY|||||||0.81|||||||Kruskal-Wallis|||Comparison across groups at baseline||||0.81
72374043|NCT00955201|144258630|SUPERIORITY|||||||0.6|||||||Kruskal-Wallis|||Comparison across groups at 12-wks||||0.60
72374044|NCT00955201|144258630|SUPERIORITY|||||||0.99|||||||Kruskal-Wallis|||Comparison across groups at 24-wks||||0.99
72374045|NCT00955201|144258631|SUPERIORITY|||||||0.59|||||||ANOVA|||Comparison across groups at baseline.||||0.59
72374046|NCT00955201|144258632|SUPERIORITY|||||||0.98||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time.||||0.98
72374047|NCT00955201|144258632|SUPERIORITY|||||||1||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time.||||1.00
72374048|NCT00955201|144258632|SUPERIORITY|||||||1||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time.||||1.00
72374049|NCT00955201|144258632|SUPERIORITY|||||||0.72||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time.||||0.72
72374050|NCT00955201|144258632|SUPERIORITY|||||||0.62|||||||ANOVA|||Comparison across groups at baseline.||||0.62
72374051|NCT00955201|144258632|SUPERIORITY|||||||0.33|||||||ANOVA|||Comparison across groups at 12 wks.||||0.33
72374052|NCT00955201|144258632|SUPERIORITY|||||||0.38|||||||ANOVA|||Comparison across groups at 24 wks.||||0.38
72374053|NCT00955201|144258633|SUPERIORITY|||||||0.88||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time.||||0.88
72374054|NCT00955201|144258633|SUPERIORITY|||||||1||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time.||||1.00
72374055|NCT00955201|144258633|SUPERIORITY|||||||1||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time.||||1.00
72374056|NCT00955201|144258633|SUPERIORITY|||||||0.76||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time.||||0.76
72374057|NCT00955201|144258633|SUPERIORITY|||||||0.82|||||||ANOVA|||Comparison across groups at baseline.||||0.82
72374058|NCT00955201|144258633|SUPERIORITY|||||||0.53|||||||ANOVA|||Comparison across groups at 12 wks.||||0.53
72374059|NCT00955201|144258633|SUPERIORITY|||||||0.68|||||||ANOVA|||Comparison across groups at 24 wks.||||0.68
72374060|NCT00955201|144258634|SUPERIORITY|||||||0.7|||||||ANOVA|||Comparison across groups at baseline.||||0.70
72374061|NCT00955201|144258636|SUPERIORITY|||||||0.59|||||||ANOVA|||Comparison across groups at baseline.||||0.59
72374062|NCT00955201|144258637|SUPERIORITY|||||||0.45|||||||ANOVA|||Comparison across groups at baseline.||||0.45
72374063|NCT00955201|144258638|SUPERIORITY|||||||0.04|||||||ANOVA|||Comparison across groups at baseline.||||0.04
72374064|NCT00955201|144258639|SUPERIORITY|||||||0.77|||||||ANOVA|||Comparison across groups at baseline.||||0.77
72374065|NCT00955201|144258640|SUPERIORITY|||||||0.12|||||||ANOVA|||Comparison across groups at baseline.||||0.12
72374066|NCT00955201|144258641|SUPERIORITY|||||||0.42|||||||ANOVA|||Comparison across groups at baseline.||||0.42
72374067|NCT00955201|144258642|SUPERIORITY|||||||0.79|||||||ANOVA|||Comparison across groups at baseline.||||0.79
72374068|NCT03032380|144258643|NON_INFERIORITY|The study hypothesis was that the all-cause mortality rate at Day 14 in participants who received cefiderocol would be non-inferior to that in participants who received high-dose meropenem. The margin of non-inferiority was 12.5%. Non-inferiority was concluded if the upper bound of the 2-sided 95% confidence interval for the difference in mortality at Day 14 between the 2 treatment groups (cefiderocol - meropenem) was smaller than 12.5%.|Treatment Difference|0.8||||0.002|TWO_SIDED|95.0|-6.6|8.2|||Cochran-Mantel-Haenszel||Treatment difference (cefiderocol - meropenem) was the adjusted estimate of the difference in the ACM rate at Day 14 based on Cochran-Mantel Haenszel weights using APACHE II score (≤ 15 and ≥ 16) as the stratification factor.|||8.2|-6.6|0.0020
72374069|NCT03032380|144258644|SUPERIORITY||Treatment Difference|-1.4|||||TWO_SIDED|95.0|-13.5|10.7|||||Treatment difference (cefiderocol - meropenem) was the adjusted estimate of the difference in the eradication rate calculated using Cochran-Mantel-Haenszel weights based on infection diagnosis (HABP/VABP/HCABP), and APACHE II score (≤ 15 and ≥ 16).|||10.7|-13.5|
72374070|NCT03032380|144258645|SUPERIORITY||Treatment Difference|-2.0|||||TWO_SIDED|95.0|-12.5|8.5|||||Treatment difference (cefiderocol - meropenem) was the adjusted estimate of the difference in the cure rate calculated using Cochran-Mantel-Haenszel weights based on infection diagnosis (HABP/VABP/HCABP), and APACHE II score (≤ 15 and ≥ 16).|||8.5|-12.5|
72374071|NCT03032380|144258646|OTHER||Treatment Difference|-0.3|||||TWO_SIDED|95.0|-8.8|8.2|||||Treatment difference (cefiderocol - meropenem) was the adjusted estimate of the difference in the cure rate calculated using Cochran-Mantel-Haenszel weights based on infection diagnosis (HABP/VABP/HCABP), and APACHE II score (≤ 15 and ≥ 16).|||8.2|-8.8|
72374072|NCT03032380|144258647|OTHER||Treatment Difference|-3.8|||||TWO_SIDED|95.0|-12.8|5.1|||||Treatment difference (cefiderocol - meropenem) was the adjusted estimate of the difference in the cure rate calculated using Cochran-Mantel-Haenszel weights based on infection diagnosis (HABP/VABP/HCABP), and APACHE II score (≤ 15 and ≥ 16).|||5.1|-12.8|
72374073|NCT03032380|144258648|OTHER||Treatment Difference|-0.1|||||TWO_SIDED|95.0|-10.9|10.8|||||Treatment difference (cefiderocol - meropenem) was the adjusted estimate of the difference in the cure rate calculated using Cochran-Mantel-Haenszel weights based on infection diagnosis (HABP/VABP/HCABP), and APACHE II score (≤ 15 and ≥ 16).|||10.8|-10.9|
72374074|NCT03032380|144258649|OTHER||Treatment Difference|-12.4|||||TWO_SIDED|95.0|-24.4|-0.5|||||Treatment difference (cefiderocol - meropenem) was the adjusted estimate of the difference in the cure rate calculated using Cochran-Mantel-Haenszel weights based on infection diagnosis (HABP/VABP/HCABP), and APACHE II score (≤ 15 and ≥ 16).|||-0.5|-24.4|
72374075|NCT03032380|144258650|OTHER||Treatment Difference|-3.8|||||TWO_SIDED|95.0|-15.5|7.9|||||Treatment difference (cefiderocol - meropenem) was the adjusted estimate of the difference in the cure rate calculated using Cochran-Mantel-Haenszel weights based on infection diagnosis (HABP/VABP/HCABP), and APACHE II score (≤ 15 and ≥ 16).|||7.9|-15.5|
72504451|NCT03726671|144539459|OTHER|||||||0.0819|||||||Wilcoxon (Mann-Whitney)|Non-parametric method was used due to data deviation from normality.||||||0.0819
72555367|NCT00950989|144642301|SUPERIORITY||Difference in response rate|-3.2||||0.572|TWO_SIDED|95.0|-14.1|7.8||P-value is nominal p-value without multiplicity adjustment based on Cochran-Mantel-Haenszel test adjusting for sex.|Cochran-Mantel-Haenszel|||||7.8|-14.1|0.572
72555368|NCT00950989|144642301|SUPERIORITY|||||||0.572||||||Adjusted p-value is based on a combination of sequential testing and the Hommel procedure to control the overall significance level for all the comparisons.|Sequential testing + Hommel procedure|||||||0.572
72374076|NCT03032380|144258651|OTHER||Treatment Difference|3.9|||||TWO_SIDED|95.0|-7.9|15.8|||||Treatment difference (cefiderocol - meropenem) was the adjusted estimate of the difference in the cure rate calculated using Cochran-Mantel-Haenszel weights based on infection diagnosis (HABP/VABP/HCABP), and APACHE II score (≤ 15 and ≥ 16).|||15.8|-7.9|
72374077|NCT03032380|144258652|OTHER||Treatment Difference|0.5|||||TWO_SIDED|95.0|-8.7|9.8|||||Treatment difference (cefiderocol - meropenem) was the adjusted estimate of the difference in the ACM rate at Day 28 based on Cochran-Mantel Haenszel weights using APACHE II score (≤ 15 and ≥ 16) as the stratification factor.|||9.8|-8.7|
72374078|NCT03032380|144258653|OTHER||Treatment Difference|3.6|||||TWO_SIDED|95.0|-6.3|13.4|||||Treatment difference (cefiderocol - meropenem) was the adjusted estimate of the difference in the ACM rate at EOS based on Cochran-Mantel Haenszel weights using APACHE II score (≤ 15 and ≥ 16) as the stratification factor.|||13.4|-6.3|
72374079|NCT03032380|144258654|SUPERIORITY|||||||0.9382|||||||t-test, 2 sided|||Comparison of Hospitalization time at test of cure||||0.9382
72374080|NCT03032380|144258654|SUPERIORITY|||||||0.6552|||||||t-test, 2 sided|||Comparison of hospitalization time at follow-up||||0.6552
72374081|NCT01128621|144258701|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.216|||||TWO_SIDED|95.0|-1.0|0.57||||||Placebo vs GSK1292263 75 mg: Day 7, pre-breakfast||0.57|-1.00|
72374082|NCT01128621|144258701|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.29|||||TWO_SIDED|95.0|-0.53|1.11||||||Placebo vs GSK1292263 300 mg: Day 7, pre-breakfast||1.11|-0.53|
72374083|NCT01128621|144258701|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.748|||||TWO_SIDED|95.0|-0.02|1.52||||||Placebo vs GSK1292263 600 mg: Day 7, pre-breakfast||1.52|-0.02|
72374084|NCT01128621|144258701|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.207|||||TWO_SIDED|95.0|-2.01|-0.41||||||Placebo vs Sitagliptin 50 mg: Day 7, pre-breakfast||-0.41|-2.01|
72374085|NCT01128621|144258701|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.991|||||TWO_SIDED|95.0|0.18|1.81||||||GSK1292263 75 mg vs Sitagliptin 50 mg: Day 7 , pre-breakfast||1.81|0.18|
72374086|NCT01128621|144258701|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.497|||||TWO_SIDED|95.0|0.66|2.34||||||GSK1292263 300 mg vs Sitagliptin 50 mg: Day 7, pre-breakfast||2.34|0.66|
72374087|NCT01128621|144258701|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.955|||||TWO_SIDED|95.0|1.16|2.75||||||GSK1292263 600 mg vs Sitagliptin 50 mg: Day 7, pre-breakfast||2.75|1.16|
72374088|NCT01128621|144258701|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.78|||||TWO_SIDED|95.0|-1.74|0.18||||||Placebo vs GSK1292263 75 mg: Day 14, pre-breakfast||0.18|-1.74|
72374089|NCT01128621|144258701|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.188|||||TWO_SIDED|95.0|-0.81|1.19||||||Placebo vs GSK1292263 300 mg: Day 14, pre-breakfast||1.19|-0.81|
72374090|NCT01128621|144258701|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.6|||||TWO_SIDED|95.0|-0.35|1.55||||||Placebo vs GSK1292263 600 mg: Day 14, pre-breakfast||1.55|-0.35|
72374091|NCT01128621|144258701|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.069|||||TWO_SIDED|95.0|-2.05|-0.08||||||Placebo vs Sitagliptin 50 mg: Day 14, pre-breakfast||-0.08|-2.05|
72374092|NCT01128621|144258701|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.289|||||TWO_SIDED|95.0|-0.71|1.29||||||GSK1292263 75 mg vs Sitagliptin 50 mg: Day 14, pre-breakfast||1.29|-0.71|
72374093|NCT01128621|144258701|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.257|||||TWO_SIDED|95.0|0.22|2.29||||||GSK1292263 300 mg vs Sitagliptin 50 mg: Day 14, pre-breakfast||2.29|0.22|
72374094|NCT01128621|144258701|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.669|||||TWO_SIDED|95.0|0.68|2.65||||||GSK1292263 600 mg vs Sitagliptin 50 mg: Day 14, pre-breakfast||2.65|0.68|
72374095|NCT01128621|144258701|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.556|||||TWO_SIDED|95.0|-1.65|0.54||||||Placebo vs GSK1292263 75 mg: Day 14, 24 hours||0.54|-1.65|
72374096|NCT01128621|144258701|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.745|||||TWO_SIDED|95.0|-0.4|1.89||||||Placebo vs GSK1292263 300 mg: Day 14, 24 hours||1.89|-0.40|
72374097|NCT01128621|144258701|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.711|||||TWO_SIDED|95.0|-0.36|1.78||||||Placebo vs GSK1292263 600 mg: Day 14, 24 hours||1.78|-0.36|
72374098|NCT01128621|144258701|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.03|||||TWO_SIDED|95.0|-2.15|0.09||||||Placebo vs Sitagliptin 50 mg: Day 14, 24 hours||0.09|-2.15|
72374099|NCT01128621|144258701|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.474|||||TWO_SIDED|95.0|-0.66|1.61||||||GSK1292263 75 mg vs Sitagliptin 50 mg: Day 14, 24 hours||1.61|-0.66|
72374100|NCT01128621|144258701|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.775|||||TWO_SIDED|95.0|0.6|2.95||||||GSK1292263 300 mg vs Sitagliptin 50 mg: Day 14, 24 hours||2.95|0.60|
72374101|NCT01128621|144258701|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.741|||||TWO_SIDED|95.0|0.63|2.86||||||GSK1292263 600 mg vs Sitagliptin 50 mg: Day 14, 24 hours||2.86|0.63|
72374102|NCT01128621|144258702|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.195|||||TWO_SIDED|95.0|-17.17|17.56||||||Placebo vs GSK1292263 75 mg: Day 7, pre-breakfast||17.56|-17.17|
72374103|NCT01128621|144258702|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-16.863|||||TWO_SIDED|95.0|-34.7|0.98||||||Placebo vs GSK1292263 300 mg: Day 7, pre-breakfast||0.98|-34.70|
72374104|NCT01128621|144258702|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.46|||||TWO_SIDED|95.0|-23.04|12.12||||||Placebo vs GSK1292263 600 mg: Day 7, pre-breakfast||12.12|-23.04|
72374105|NCT01128621|144258702|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.85|||||TWO_SIDED|95.0|-13.89|21.58||||||Placebo vs Sitagliptin 50 mg: Day 7, pre-breakfast||21.58|-13.89|
72374106|NCT01128621|144258702|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.655|||||TWO_SIDED|95.0|-21.7|14.39||||||GSK1292263 75 mg vs Sitagliptin 50 mg: Day 7, pre-breakfast||14.39|-21.70|
72374107|NCT01128621|144258702|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-20.712|||||TWO_SIDED|95.0|-39.25|-2.17||||||GSK1292263 300 mg vs Sitagliptin 50 mg: Day 7, pre-breakfast||-2.17|-39.25|
72374108|NCT01128621|144258702|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-9.31|||||TWO_SIDED|95.0|-27.63|9.01||||||GSK1292263 600 mg vs Sitagliptin 50 mg: Day 7, pre-breakfast||9.01|-27.63|
72374109|NCT01128621|144258702|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.649|||||TWO_SIDED|95.0|-19.43|12.14||||||Placebo vs GSK1292263 75 mg: Day 14, pre-breakfast||12.14|-19.43|
72374110|NCT01128621|144258702|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-16.66|||||TWO_SIDED|95.0|-32.72|-0.6||||||Placebo vs GSK1292263 300 mg: Day 14, pre-breakfast||-0.60|-32.72|
72374111|NCT01128621|144258702|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-22.251|||||TWO_SIDED|95.0|-38.34|-6.16||||||Placebo vs GSK1292263 600 mg: Day 14, pre-breakfast||-6.16|-38.34|
72374112|NCT01128621|144258702|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.59|||||TWO_SIDED|95.0|-20.69|11.51||||||Placebo vs Sitagliptin 50 mg: Day 14, pre-breakfast||11.51|-20.69|
72374113|NCT01128621|144258702|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.941|||||TWO_SIDED|95.0|-15.4|17.28||||||GSK1292263 75 mg vs Sitagliptin 50 mg: Day 14, pre-breakfast||17.28|-15.40|
72504452|NCT03726671|144539459|OTHER|||||||0.9015|||||||t-test, 2 sided|||||||0.9015
72374114|NCT01128621|144258702|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-12.07|||||TWO_SIDED|95.0|-28.82|4.68||||||GSK1292263 300 mg vs Sitagliptin 50 mg: Day 14, pre-breakfast||4.68|-28.82|
72374115|NCT01128621|144258702|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-17.662|||||TWO_SIDED|95.0|-34.72|-0.6||||||GSK1292263 600 mg vs Sitagliptin 50 mg: Day 14, pre-breakfast||-0.60|-34.72|
72374116|NCT01128621|144258702|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-19.101|||||TWO_SIDED|95.0|-44.0|5.8||||||Placebo vs GSK1292263 75 mg: Day 14, 24 hours||5.80|-44.00|
72555369|NCT00950989|144642302|SUPERIORITY||Difference in response rates|-3.2||||0.728|TWO_SIDED|95.0|-20.4|14.0||P-value is nominal p-value without multiplicity adjustment based on Cochran-Mantel-Haenszel test adjusting for sex.|Cochran-Mantel-Haenszel|||||14.0|-20.4|0.728
72555370|NCT00950989|144642302|SUPERIORITY|||||||0.993||||||Adjusted p-value is based on a combination of sequential testing and the Hommel procedure to control the overall significance level for all the comparisons.|Sequential testing + Hommel procedure|||||||0.993
72374117|NCT01128621|144258702|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-27.976|||||TWO_SIDED|95.0|-53.56|-2.39||||||Placebo vs GSK1292263 300 mg: Day 14, 24 hours||-2.39|-53.56|
72374118|NCT01128621|144258702|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-23.609|||||TWO_SIDED|95.0|-48.82|1.6||||||Placebo vs GSK1292263 600 mg: Day 14, 24 hours||1.60|-48.82|
72374119|NCT01128621|144258702|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.094|||||TWO_SIDED|95.0|-22.34|28.53||||||Placebo vs Sitagliptin 50 mg: Day 14, 24 hours||28.53|-22.34|
72374120|NCT01128621|144258702|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-22.194|||||TWO_SIDED|95.0|-48.07|3.69||||||GSK1292263 75 mg vs Sitagliptin 50 mg: Day 14, 24 hours||3.69|-48.07|
72374121|NCT01128621|144258702|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-31.07|||||TWO_SIDED|95.0|-57.66|-4.48||||||GSK1292263 300 mg vs Sitagliptin 50 mg: Day 14, 24 hours||-4.48|-57.66|
72374122|NCT01128621|144258702|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-26.703|||||TWO_SIDED|95.0|-52.98|-0.42||||||GSK1292263 600 mg vs Sitagliptin 50 mg: Day 14, 24 hours||-0.42|-52.98|
72374123|NCT01128621|144258705|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.5|||||TWO_SIDED|95.0|-1.5|0.5||||||Placebo vs GSK1292263 75 mg: Weighted Mean (0-12), Day 7||0.50|-1.50|
72374124|NCT01128621|144258705|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.513|||||TWO_SIDED|95.0|-0.51|1.54||||||Placebo vs GSK1292263 300 mg: Weighted Mean (0-12), Day 7||1.54|-0.51|
72374125|NCT01128621|144258705|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.03|||||TWO_SIDED|95.0|0.05|2.01||||||Placebo vs GSK1292263 600 mg: Weighted Mean (0-12), Day 7||2.01|0.05|
72374126|NCT01128621|144258705|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.955|||||TWO_SIDED|95.0|-1.98|0.07||||||Placebo vs Sitagliptin 50 mg: Weighted Mean (0-12), Day 7||0.07|-1.98|
72374127|NCT01128621|144258705|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.454|||||TWO_SIDED|95.0|-0.59|1.5||||||GSK1292263 75 mg vs Sitagliptin 50 mg: Weighted Mean (0-12), Day 7||1.50|-0.59|
72374128|NCT01128621|144258705|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.468|||||TWO_SIDED|95.0|0.39|2.55||||||GSK1292263 300 mg vs Sitagliptin 50 mg: Weighted Mean (0-12), Day 7||2.55|0.39|
72374129|NCT01128621|144258705|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.985|||||TWO_SIDED|95.0|0.96|3.01||||||GSK1292263 600 mg vs Sitagliptin 50 mg: Weighted Mean (0-12), Day 7||3.01|0.96|
72374130|NCT01128621|144258705|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.312|||||TWO_SIDED|95.0|-1.38|0.76||||||Placebo vs GSK1292263 75 mg: Weighted Mean (0-12), Day 14||0.76|-1.38|
72374131|NCT01128621|144258705|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.394|||||TWO_SIDED|95.0|-0.7|1.49||||||Placebo vs GSK1292263 300 mg: Weighted Mean (0-12), Day 14||1.49|-0.70|
72374132|NCT01128621|144258705|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.875|||||TWO_SIDED|95.0|-0.18|1.93||||||Placebo vs GSK1292263 600 mg: Weighted Mean (0-12), Day 14||1.93|-0.18|
72374133|NCT01128621|144258705|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.854|||||TWO_SIDED|95.0|-1.95|0.25||||||Placebo vs Sitagliptin 50 mg: Weighted Mean (0-12), Day 14||0.25|-1.95|
72374134|NCT01128621|144258705|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.542|||||TWO_SIDED|95.0|-0.58|1.66||||||GSK1292263 75 mg vs Sitagliptin 50 mg: Weighted Mean (0-12), Day 14||1.66|-0.58|
72374135|NCT01128621|144258705|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.248|||||TWO_SIDED|95.0|0.09|2.4||||||GSK1292263 300 mg vs Sitagliptin 50 mg: Weighted Mean (0-12), Day 14||2.40|0.09|
72374136|NCT01128621|144258705|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.729|||||TWO_SIDED|95.0|0.63|2.83||||||GSK1292263 600 mg vs Sitagliptin 50 mg: Weighted Mean (0-12), Day 14||2.83|0.63|
72374137|NCT01128621|144258705|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.148|||||TWO_SIDED|95.0|-1.21|0.91||||||Placebo vs GSK1292263 75 mg: Weighted Mean (0-24), Day 14||0.91|-1.21|
72374138|NCT01128621|144258705|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.737|||||TWO_SIDED|95.0|-0.34|1.81||||||Placebo vs GSK1292263 300 mg: Weighted Mean (0-24), Day 14||1.81|-0.34|
72374139|NCT01128621|144258705|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.245|||||TWO_SIDED|95.0|0.21|2.28||||||Placebo vs GSK1292263 600 mg: Weighted Mean (0-24), Day 14||2.28|0.21|
72374140|NCT01128621|144258705|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.623|||||TWO_SIDED|95.0|-1.71|0.46||||||Placebo vs Sitagliptin 50 mg: Weighted Mean (0-24), Day 14||0.46|-1.71|
72374141|NCT01128621|144258705|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.475|||||TWO_SIDED|95.0|-0.62|1.57||||||GSK1292263 75 mg vs Sitagliptin 50 mg: Weighted Mean (0-24), Day 14||1.57|-0.62|
72374142|NCT01128621|144258705|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.36|||||TWO_SIDED|95.0|0.23|2.49||||||GSK1292263 300 mg vs Sitagliptin 50 mg: Weighted Mean (0-24), Day 14||2.49|0.23|
72374143|NCT01128621|144258705|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.869|||||TWO_SIDED|95.0|0.79|2.95||||||GSK1292263 600 mg vs Sitagliptin 50 mg: Weighted Mean (0-24), Day 14||2.95|0.79|
72374144|NCT01128621|144258706|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-28.619|||||TWO_SIDED|95.0|-59.25|2.01||||||Placebo vs GSK1292263 75 mg: Weighted Mean (0-12), Day 7||2.01|-59.25|
72374145|NCT01128621|144258706|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-47.898|||||TWO_SIDED|95.0|-79.23|-16.56||||||Placebo vs GSK1292263 300 mg: Weighted Mean (0-12), Day 7||-16.56|-79.23|
72374146|NCT01128621|144258706|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-24.665|||||TWO_SIDED|95.0|-55.53|6.2||||||Placebo vs GSK1292263 600 mg: Weighted Mean (0-12), Day 7||6.20|-55.53|
72374147|NCT01128621|144258706|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.438|||||TWO_SIDED|95.0|-36.76|25.89||||||Placebo vs Sitagliptin 50 mg: Weighted Mean (0-12), Day 7||25.89|-36.76|
72374148|NCT01128621|144258706|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-23.181|||||TWO_SIDED|95.0|-55.0|8.63||||||GSK1292263 75 mg vs Sitagliptin 50 mg: Weighted Mean (0-12), Day 7||8.63|-55.00|
72374149|NCT01128621|144258706|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-42.46|||||TWO_SIDED|95.0|-75.18|-9.74||||||GSK1292263 300 mg vs Sitagliptin 50 mg: Weighted Mean (0-12), Day 7||-9.74|-75.18|
72374150|NCT01128621|144258706|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-19.227|||||TWO_SIDED|95.0|-51.83|13.37||||||GSK1292263 600 mg vs Sitagliptin 50 mg: Weighted Mean (0-12), Day 7||13.37|-51.83|
72374151|NCT01128621|144258706|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-18.435|||||TWO_SIDED|95.0|-49.15|12.28||||||Placebo vs GSK1292263 75 mg: Weighted Mean (0-12), Day 14||12.28|-49.15|
72374152|NCT01128621|144258706|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-58.658|||||TWO_SIDED|95.0|-90.08|-27.24||||||Placebo vs GSK1292263 300 mg: Weighted Mean (0-12), Day 14||-27.24|-90.08|
72374153|NCT01128621|144258706|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-37.006|||||TWO_SIDED|95.0|-67.96|-6.05||||||Placebo vs GSK1292263 600 mg: Weighted Mean (0-12), Day 14||-6.05|-67.96|
72374154|NCT01128621|144258706|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-9.896|||||TWO_SIDED|95.0|-41.31|21.52||||||Placebo vs Sitagliptin 50 mg: Weighted Mean (0-12), Day 14||21.52|-41.31|
72374155|NCT01128621|144258706|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-8.539|||||TWO_SIDED|95.0|-40.44|23.36||||||GSK1292263 75 mg vs Sitagliptin 50 mg: Weighted Mean (0-12), Day 14||23.36|-40.44|
72374156|NCT01128621|144258706|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-48.762|||||TWO_SIDED|95.0|-81.58|-15.95||||||GSK1292263 300 mg vs Sitagliptin 50 mg: Weighted Mean (0-12), Day 14||-15.95|-81.58|
72374157|NCT01128621|144258706|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-27.11|||||TWO_SIDED|95.0|-59.8|5.58||||||GSK1292263 600 mg vs Sitagliptin 50 mg: Weighted Mean (0-12), Day 14||5.58|-59.80|
72374158|NCT01128621|144258706|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-20.359|||||TWO_SIDED|95.0|-48.95|8.23||||||Placebo vs GSK1292263 75 mg: Weighted Mean (0-24), Day 14||8.23|-48.95|
72374159|NCT01128621|144258706|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-53.712|||||TWO_SIDED|95.0|-82.92|-24.5||||||Placebo vs GSK1292263 300 mg: Weighted Mean (0-24), Day 14||-24.50|-82.92|
72374160|NCT01128621|144258706|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-37.552|||||TWO_SIDED|95.0|-66.24|-8.86||||||Placebo vs GSK1292263 600 mg: Weighted Mean (0-24), Day 14||-8.86|-66.24|
72374161|NCT01128621|144258706|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-7.963|||||TWO_SIDED|95.0|-37.2|21.27||||||Placebo vs Sitagliptin 50 mg: Weighted Mean (0-24), Day 14||21.27|-37.20|
72374162|NCT01128621|144258706|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-12.397|||||TWO_SIDED|95.0|-42.1|17.3||||||GSK1292263 75 mg vs Sitagliptin 50 mg: Weighted Mean (0-24), Day 14||17.30|-42.10|
72493703|NCT02889796|144516552|SUPERIORITY||Least Squares Mean Difference|-0.27|STANDARD_ERROR_OF_MEAN|0.078|<|0.001|TWO_SIDED|95.0|-0.43|-0.12||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.12|-0.43|<0.001
72493704|NCT02889796|144516552|SUPERIORITY||Least Squares Mean Difference|-0.25|STANDARD_ERROR_OF_MEAN|0.078||0.001|TWO_SIDED|95.0|-0.4|-0.1||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.10|-0.40|0.001
72493705|NCT02889796|144516553|SUPERIORITY||Difference in Response Rates|26.3|||<|0.001|TWO_SIDED|95.0|20.2|32.4||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg vs Placebo at Week 12||32.4|20.2|<0.001
72374163|NCT01128621|144258706|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-45.749|||||TWO_SIDED|95.0|-76.2|-15.3||||||GSK1292263 300 mg vs Sitagliptin 50 mg: Weighted Mean (0-24), Day 14||-15.30|-76.20|
72374164|NCT01128621|144258706|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-29.59|||||TWO_SIDED|95.0|-59.82|0.64||||||GSK1292263 600 mg vs Sitagliptin 50 mg: Weighted Mean (0-24), Day 14||0.64|-59.82|
72374165|NCT00913458|144258743|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.8|||<|0.0001|TWO_SIDED|95.0|2.7|12.5||The rate of sustained remission was analyzed using a logistic regression model with a 2-sided significance level of 5%.|Regression, Logistic|Values are based on a logistic regression model with treatment as the only factor.||The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.||12.5|2.7|<0.0001
72374166|NCT00913458|144258743|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.61||||0.0085|TWO_SIDED|95.0|1.3|5.3||The rate of sustained remission was analyzed using a logistic regression model with a 2-sided significance level of 5%.|Regression, Logistic|Values are based on a logistic regression model with treatment as the only factor.||The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.||5.3|1.3|0.0085
72374167|NCT00913458|144258743|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.22||||0.0397|TWO_SIDED|95.0|1.0|4.8||The rate of sustained remission was analyzed using a logistic regression model with a 2-sided significance level of 5%.|Regression, Linear|Values are based on a logistic regression model with treatment as the only factor.||The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.||4.8|1.0|0.0397
72374168|NCT00913458|144258744|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Binomial test|||"Binomial test-value tests the null hypothesis that the proportion is significantly different from 0.~End of Phase 1"||||<0.0001
72374169|NCT00913458|144258745|SUPERIORITY_OR_OTHER|||||||0.1183|TWO_SIDED||||||Paired t-test|||"Significance tests were based on paired t-tests using a 2-sided α=0.05.~Week 52"||||0.1183
72374170|NCT00913458|144258745|SUPERIORITY_OR_OTHER|||||||0.0286|TWO_SIDED||||||Paired t-test|||"Significance tests were based on paired t-tests using a 2-sided α=0.05.~Final on therapy"||||0.0286
72374171|NCT00913458|144258746|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Paired t-test|||"Significance tests were based on paired t-tests using a 2-sided α=0.05.~Week 13, 26, 39, 52 and final on therapy"||||<0.0001
72493706|NCT02889796|144516553|SUPERIORITY||Difference in Response Rates|15.4|||<|0.001|TWO_SIDED|95.0|9.4|21.4||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg vs Placebo at Week 12||21.4|9.4|<0.001
72493707|NCT02889796|144516553|NON_INFERIORITY|For non-inferiority test, the approach proposed by Liu 2014 was used to demonstrate that each filgotinib dose preserves more than 50% of the effect of adalimumab on the response rate of DAS28 (CRP) ≤ 3.2 using NRI.|||||<|0.001||||||P-value of non-inferiority test was calculated from approach proposed by \[Liu 2014\].|Method proposed by [Liu 2014]|||Filgotinib 200 mg vs Adalimumab at Week 12||||<0.001
72493708|NCT02889796|144516553|NON_INFERIORITY|For non-inferiority test, the approach proposed by Liu 2014 was used to demonstrate that each filgotinib dose preserves more than 50% of the effect of adalimumab on the response rate of DAS28 (CRP) ≤ 3.2 using NRI.||||||0.054||||||P-value of non-inferiority test was calculated from approach proposed by \[Liu 2014\].|Method proposed by [Liu 2014]|||Filgotinib 100 mg vs Adalimumab at Week 12||||0.054
72504453|NCT03726671|144539459|OTHER|||||||0.1191|||||||Wilcoxon (Mann-Whitney)|Non-parametric method was used due to data deviation from normality.||||||0.1191
72504454|NCT03726671|144539460|OTHER|||||||0.2351|||||||Pearson's Correlation Coefficient|||Liver choline concentration vs. betaine IER||||0.2351
72504455|NCT03726671|144539460|OTHER|||||||0.4501|||||||Pearson's Correlation Coefficient|||Liver choline concentration vs. Phosphatidylcholine IER||||0.4501
72504456|NCT03726671|144539460|OTHER|||||||0.4136|||||||Pearson's Correlation Coefficient|||Liver choline concentration vs. Choline IER||||0.4136
72504457|NCT03726671|144539460|OTHER|||||||0.9463|||||||Pearson's Correlation Coefficient|||Liver choline concentration vs. Betaine IER||||0.9463
72504458|NCT03726671|144539460|OTHER|||||||0.0675|||||||Pearson's Correlation Coefficient|||Liver choline concentration vs. Phosphatidylcholine IER||||0.0675
72504459|NCT03726671|144539460|OTHER|||||||0.2863|||||||Pearson's Correlation Coefficient|||Liver choline concentration vs. Choline IER||||0.2863
72504460|NCT03726671|144539460|OTHER|||||||0.5552|||||||Pearson's Correlation Coefficient|||Liver choline concentration vs. Betaine IER||||0.5552
72374172|NCT00913458|144258747|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Paired t-test|||"Significance tests were based on paired t-tests using a 2-sided α=0.05.~Week 13, 26, 39, 52 and final on therapy"||||<0.0001
72374173|NCT00913458|144258748|SUPERIORITY_OR_OTHER|||||||0.0063|TWO_SIDED||||||Paired t-test|||"Significance tests were based on paired t-tests using a 2-sided α=0.05.~Week 13"||||0.0063
72374174|NCT00913458|144258748|SUPERIORITY_OR_OTHER|||||||0.0053|TWO_SIDED||||||Paired t-test|||"Significance tests were based on paired t-tests using a 2-sided α=0.05.~Week 26"||||0.0053
72374175|NCT00913458|144258748|SUPERIORITY_OR_OTHER|||||||0.0027|TWO_SIDED||||||Paired t-test|||"Significance tests were based on paired t-tests using a 2-sided α=0.05.~Week 39"||||0.0027
72374176|NCT00913458|144258748|SUPERIORITY_OR_OTHER|||||||0.0002|TWO_SIDED||||||Paired t-test|||"Significance tests were based on paired t-tests using a 2-sided α=0.05.~Week 52"||||0.0002
72374177|NCT00913458|144258748|SUPERIORITY_OR_OTHER|||||||0.0005|TWO_SIDED||||||Paired t-test|||"Significance tests were based on paired t-tests using a 2-sided α=0.05.~Final on therapy"||||0.0005
72555371|NCT00950989|144642302|SUPERIORITY||Difference in response rates|-6.3||||0.412|TWO_SIDED|95.0|-23.4|10.7||P-value is nominal p-value without multiplicity adjustment based on Cochran-Mantel-Haenszel test adjusting for sex.|Cochran-Mantel-Haenszel|||||10.7|-23.4|0.412
72374178|NCT00913458|144258749|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Paired t-test|||"Significance tests were based on paired t-tests using a 2-sided α=0.05.~Week 13, 26, 39, 52 and final on therapy"||||<0.0001
72555372|NCT00950989|144642302|SUPERIORITY|||||||0.74||||||Adjusted p-value is based on a combination of sequential testing and the Hommel procedure to control the overall significance level for all the comparisons.|Sequential testing + Hommel procedures|||||||0.740
72555373|NCT00950989|144642302|SUPERIORITY||Difference in response rates|3.2||||0.74|TWO_SIDED|95.0|-14.2|20.5||P-value is nominal p-value without multiplicity adjustment based on Cochran-Mantel-Haenszel test adjusting for sex.|Cochran-Mantel-Haenszel|||||20.5|-14.2|0.740
72555374|NCT00950989|144642302|SUPERIORITY|||||||0.993||||||Adjusted p-value is based on a combination of sequential testing and the Hommel procedure to control the overall significance level for all the comparisons.|Sequential testing + Hommel procedure|||||||0.993
72555375|NCT00950989|144642303|SUPERIORITY||Difference in response rates|0.0||||0.984|TWO_SIDED|95.0|-6.1|6.1||P-value is nominal p-value without multiplicity adjustment based on Cochran-Mantel-Haenszel test adjusting for sex.|Cochran-Mantel-Haenszel|||||6.1|-6.1|0.984
72555376|NCT00950989|144642303|SUPERIORITY|||||||0.993||||||Adjusted p-value is based on a combination of sequential testing and the Hommel procedure to control the overall significance level for all the comparisons.|Sequential testing + Hommel procedure|||||||0.993
72555377|NCT00950989|144642303|SUPERIORITY||Difference in response rates|0.0||||0.993|TWO_SIDED|95.0|-6.1|6.1||P-value is nominal p-value without multiplicity adjustment based on Cochran-Mantel-Haenszel test adjusting for sex.|Cochran-Mantel-Haenszel|||||6.1|-6.1|0.993
72555378|NCT00950989|144642303|SUPERIORITY|||||||0.993||||||Adjusted p-value is based on a combination of sequential testing and the Hommel procedure to control the overall significance level for all the comparisons.|Sequential testing + Hommel procedure|||||||0.993
72555379|NCT00950989|144642303|SUPERIORITY||Difference in response rates|-3.2||||0.159|TWO_SIDED|95.0|-7.5|1.2||P-value is nominal p-value without multiplicity adjustment based on Cochran-Mantel-Haenszel test adjusting for sex.|Cochran-Mantel-Haenszel|||||1.2|-7.5|0.159
72555380|NCT00950989|144642303|SUPERIORITY|||||||0.797||||||Adjusted p-value is based on a combination of sequential testing and the Hommel procedure to control the overall significance level for all the comparisons.|Sequential testing + Hommel procedure|||||||0.797
72555381|NCT00950989|144642304|SUPERIORITY||LS Mean of difference|-0.2|STANDARD_ERROR_OF_MEAN|0.2||0.459|TWO_SIDED|95.0|-0.7|0.3||P-value is nominal without multiplicity adjustment based on ANCOVA model adjusting for sex and baseline DAS28 score.|ANCOVA|||||0.3|-0.7|0.459
72555382|NCT00950989|144642304|SUPERIORITY||LS mean of difference|0.0|STANDARD_ERROR_OF_MEAN|0.2||0.906|TWO_SIDED|95.0|-0.5|0.5||P-value is nominal without multiplicity adjustment based on ANCOVA model adjusting for sex and baseline DAS28 score.|ANCOVA|||||0.5|-0.5|0.906
72555383|NCT00950989|144642304|SUPERIORITY||LS mean of difference|0.0|STANDARD_ERROR_OF_MEAN|0.2||0.849|TWO_SIDED|95.0|-0.5|0.5||P-value is nominal without multiplicity adjustment based on ANCOVA model adjusting for sex and baseline DAS28 score.|ANCOVA|||||0.5|-0.5|0.849
72555384|NCT03804983|144642324|OTHER|Analysis of Variance||||||0.178||||||All outcomes were analyzed using repeated measure ANOVA comparing baseline to the studied period(i.e., ski admission or home use), grouped by treatment. Significance level was set at a P-Value\<0.05|ANOVA|||||||0.178
72555385|NCT03804983|144642325|OTHER|Analysis of Variance||||||0.145||||||All outcomes were analyzed using repeated measure ANOVA comparing baseline to the studied period(i.e., ski admission or home use), grouped by treatment. Significance level was set at a P-Value\<0.05|ANOVA|||||||0.145
72555386|NCT03804983|144642326|OTHER|Analysis of Variance||||||0.304||||||All outcomes were analyzed using repeated measure ANOVA comparing baseline to the studied period(i.e., ski admission or home use), grouped by treatment. Significance level was set at a P-Value\<0.05|ANOVA|||||||0.304
72555387|NCT03804983|144642327|OTHER|Analysis of Variance||||||0.131||||||All outcomes were analyzed using repeated measure ANOVA comparing baseline to the studied period(i.e., ski admission or home use), grouped by treatment. Significance level was set at a P-Value\<0.05|ANOVA|||||||0.131
72555388|NCT03804983|144642329|OTHER|Analysis of Variance||||||0.206||||||All outcomes were analyzed using repeated measure ANOVA comparing baseline to the studied period(i.e., ski admission or home use), grouped by treatment. Significance level was set at a P-Value\<0.05|ANOVA|||||||0.206
72555389|NCT03804983|144642330|OTHER|Analysis of Variance||||||0.335||||||All outcomes were analyzed using repeated measure ANOVA comparing baseline to the studied period(i.e., ski admission or home use), grouped by treatment. Significance level was set at a P-Value\<0.05|ANOVA|||||||0.335
72555390|NCT03804983|144642331|OTHER|Analysis of Variance||||||0.637||||||All outcomes were analyzed using repeated measure ANOVA comparing baseline to the studied period(i.e., ski admission or home use), grouped by treatment. Significance level was set at a P-Value\<0.05|ANOVA|||||||0.637
72555391|NCT03804983|144642332|OTHER|Analysis of Variance||||||0.347||||||All outcomes were analyzed using repeated measure ANOVA comparing baseline to the studied period(i.e., ski admission or home use), grouped by treatment. Significance level was set at a P-Value\<0.05|ANOVA|||||||0.347
72555392|NCT03804983|144642333|OTHER|Analysis of Variance||||||0.057||||||All outcomes were analyzed using repeated measure ANOVA comparing baseline to the studied period(i.e., ski admission or home use), grouped by treatment. Significance level was set at a P-Value\<0.05|ANOVA|||||||0.057
72555393|NCT03804983|144642334|OTHER|Analysis of Variance||||||0.435||||||All outcomes were analyzed using repeated measure ANOVA comparing baseline to the studied period(i.e., ski admission or home use), grouped by treatment. Significance level was set at a P-Value\<0.05|ANOVA|||||||0.435
72555394|NCT03804983|144642335|OTHER|Analysis of Variance||||||0.135||||||All outcomes were analyzed using repeated measure ANOVA comparing baseline to the studied period(i.e., ski admission or home use), grouped by treatment. Significance level was set at a P-Value\<0.05|ANOVA|||||||0.135
72504461|NCT03726671|144539460|OTHER|||||||0.4209|||||||Pearson's Correlation Coefficient|||Liver choline concentration vs. Phosphatidylcholine IER||||0.4209
72504462|NCT03726671|144539460|OTHER|||||||0.6647|||||||Pearson's Correlation Coefficient|||Liver choline concentration vs. Choline IER||||0.6647
72504463|NCT04328623|144539483|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
72504464|NCT00849693|144539484|SUPERIORITY_OR_OTHER|||||||0.193||95.0|||||Mixed Models Analysis|||||||0.193
72504465|NCT00984659|144539572|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01||||0.713|TWO_SIDED|95.0|-0.03|0.05|||t-test, 2 sided|||||0.05|-0.03|0.713
72374179|NCT00913458|144258750|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Binomial test|||"Binomial test-value tests the null hypothesis that the proportion is significantly different from 0.~Week 2, 4, 8, 13, 26, 39, 52 and final on therapy"||||<0.0001
72374180|NCT00913458|144258751|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Binomial test|||"Binomial test-value tests the null hypothesis that the proportion is significantly different from 0.~Week 2, 4, 8, 13, 26, 39, 52 week and final on therapy"||||<0.0001
72374181|NCT00913458|144258752|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Binomial test|||"Binomial test-value tests the null hypothesis that the proportion is significantly different from 0.~Week 2, 4, 8, 13, 26, 39, 52 and final on therapy"||||<0.0001
72374182|NCT00913458|144258753|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Binomial test|||"Binomial test-value tests the null hypothesis that the proportion is significantly different from 0.~Week 2, 4, 8, 13, 26, 39, 52 and final on therapy"||||<0.0001
72374183|NCT00913458|144258754|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Paired t-test|||"Significance tests were based on paired t-tests using a 2-sided α=0.05.~Week 2, 4, 8, 13, 26, 39, 52 week and final on therapy"||||<0.0001
72374184|NCT00913458|144258755|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Paired t-test|||"Significance tests were based on paired t-tests using a 2-sided α=0.05.~Week 2, 4, 8, 13, 26, 39, 52 and final on therapy"||||<0.0001
72374185|NCT00913458|144258756|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Paired t-test|||"Significance tests were based on paired t-tests using a 2-sided α=0.05.~Week 2, 4, 8, 13, 26, 39, 52 and final on therapy"||||<0.0001
72374186|NCT00913458|144258757|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Binomial test|||"Binomial test-value tests the null hypothesis that the proportion is significantly different from 0.~Week 2, 4, 8, 13, 26, 39, 52 and final on therapy"||||<0.0001
72374187|NCT00913458|144258758|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Binomial test|||"Binomial test-value tests the null hypothesis that the proportion is significantly different from 0.~Week 2, 4, 8, 13, 26, 39, 52 week and final on therapy"||||<0.0001
72374188|NCT00913458|144258759|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||McNemar|||"P-value is from McNemar's test for no change from baseline in response rate.~Week 2, 4, 8, 13, 26, 39, 52 week and final on therapy"||||<0.0001
72374189|NCT00913458|144258760|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.83||||0.4075|TWO_SIDED|95.0|0.4|7.6|||Longitudinal statistical model|Odds ratios and p-values are based on a longitudinal statistical model with factors for treatment, visit, and interaction of treatment and visit.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.||7.6|0.4|0.4075
72374190|NCT00913458|144258760|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|8.88||||0.0011|TWO_SIDED|95.0|2.4|33.1|||Longitudinal statistical model|Odds ratios and p-values are based on a longitudinal statistical model with factors for treatment, visit, and interaction of treatment and visit.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.||33.1|2.4|0.0011
72374191|NCT00913458|144258760|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.87||||0.0031|TWO_SIDED|95.0|1.7|13.9|||Longitudinal statistical model|Odds ratios and p-values are based on a longitudinal statistical model with factors for treatment, visit, and interaction of treatment and visit.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.||13.9|1.7|0.0031
72374192|NCT00913458|144258761|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.77||||0.5951|TWO_SIDED|95.0|0.3|2.0|||Longitudinal statistical model|Odds ratios and p-values are based on a longitudinal statistical model with factors for treatment, visit, and interaction of treatment and visit.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.||2.0|0.3|0.5951
72374193|NCT00913458|144258761|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.19||||0.0934|TWO_SIDED|95.0|0.9|5.5|||Longitudinal statistical model|Odds ratios and p-values are based on a longitudinal statistical model with factors for treatment, visit, and interaction of treatment and visit.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.||5.5|0.9|0.0934
72374194|NCT00913458|144258761|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.85||||0.0314|TWO_SIDED|95.0|1.1|7.4|||Longitudinal statistical model|Odds ratios and p-values are based on a longitudinal statistical model with factors for treatment, visit, and interaction of treatment and visit.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.||7.4|1.1|0.0314
72374195|NCT00913458|144258762|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.23||||0.6152|TWO_SIDED|95.0|0.5|2.8|||Longitudinal statistical model|Odds ratios and p-values are based on a longitudinal statistical model with factors for treatment, visit, and interaction of treatment and visit.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.||2.8|0.5|0.6152
72374196|NCT00913458|144258762|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.36||||0.0432|TWO_SIDED|95.0|1.0|5.4|||Longitudinal statistical model|Odds ratios and p-values are based on a longitudinal statistical model with factors for treatment, visit, and interaction of treatment and visit.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.||5.4|1.0|0.0432
72374197|NCT00913458|144258762|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.91||||0.1189|TWO_SIDED|95.0|0.8|4.3|||Longitudinal statistical model|Odds ratios and p-values are based on a longitudinal statistical model with factors for treatment, visit, and interaction of treatment and visit.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.||4.3|0.8|0.1189
72374198|NCT00913458|144258763|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.15||||0.0535|TWO_SIDED|95.0|1.0|4.7|||Longitudinal statistical model|Odds ratios and p-values are based on a longitudinal statistical model with factors for treatment, visit, and interaction of treatment and visit.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.||4.7|1.0|0.0535
72374199|NCT00913458|144258763|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.22||||0.0064|TWO_SIDED|95.0|1.4|7.5|||Longitudinal statistical model|Odds ratios and p-values are based on a longitudinal statistical model with factors for treatment, visit, and interaction of treatment and visit.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.||7.5|1.4|0.0064
72555395|NCT03804983|144642336|OTHER|Analysis of Variance||||||0.271||||||All outcomes were analyzed using repeated measure ANOVA comparing baseline to the studied period(i.e., ski admission or home use), grouped by treatment. Significance level was set at a P-Value\<0.05|ANOVA|||||||0.271
72555396|NCT03804983|144642337|OTHER|Analysis of Variance||||||1||||||All outcomes were analyzed using repeated measure ANOVA comparing baseline to the studied period(i.e., ski admission or home use), grouped by treatment. Significance level was set at a P-Value\<0.05|ANOVA|||||||1.0
72555397|NCT03804983|144642339|OTHER|Analysis of Variance||||||1||||||All outcomes were analyzed using repeated measure ANOVA comparing baseline to the studied period(i.e., ski admission or home use), grouped by treatment. Significance level was set at a P-Value\<0.05|ANOVA|||||||1.0
72555398|NCT03804983|144642340|OTHER|Analysis of Variance||||||0.294||||||All outcomes were analyzed using repeated measure ANOVA comparing baseline to the studied period(i.e., ski admission or home use), grouped by treatment. Significance level was set at a P-Value\<0.05|ANOVA|||||||0.294
72555399|NCT03804983|144642341|OTHER|Analysis of Variance||||||0.584||||||All outcomes were analyzed using repeated measure ANOVA comparing baseline to the studied period(i.e., ski admission or home use), grouped by treatment. Significance level was set at a P-Value\<0.05|ANOVA|||||||0.584
72555400|NCT03804983|144642342|OTHER|Analysis of Variance||||||0.69||||||All outcomes were analyzed using repeated measure ANOVA comparing baseline to the studied period(i.e., ski admission or home use), grouped by treatment. Significance level was set at a P-Value\<0.05|ANOVA|||||||0.69
72555401|NCT03804983|144642343|OTHER|Analysis of Variance||||||0.066||||||All outcomes were analyzed using repeated measure ANOVA comparing baseline to the studied period(i.e., ski admission or home use), grouped by treatment. Significance level was set at a P-Value\<0.05|ANOVA|||||||0.066
72555402|NCT03804983|144642344|OTHER|Analysis of Variance||||||0.904||||||All outcomes were analyzed using repeated measure ANOVA comparing baseline to the studied period(i.e., ski admission or home use), grouped by treatment. Significance level was set at a P-Value\<0.05|ANOVA|||||||0.904
72555403|NCT00424047|144642358|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.324|||<|0.001|TWO_SIDED|95.0|0.24|0.438|||Log Rank|The p-value is based on an unstratified log rank test of survival curve differences between the treatment groups|Based on a proportional hazards model comparing the hazard functions associated with the treatment groups (Lenalidomide/Dex:Placebo/Dexamethasone)|||0.438|0.240|<0.001
72555404|NCT00424047|144642359|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.73||||0.105|TWO_SIDED|95.0|0.498|1.07|||Log Rank|The p-value is based on an unstratified log rank test of survival curve differences between the treatment groups.|Based on a proportional hazards model comparing the hazard functions associated with the treatment groups (Lenalidomide/Dexamethasone:Placebo/Dexamethasone)|||1.070|0.498|0.105
72555405|NCT00424047|144642360|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.863||||0.302|TWO_SIDED|95.0|0.651|1.143|||Log Rank|The p-value is based on an unstratified log rank test of survival curve differences between the treatment groups|Based on a proportional hazards model comparing the hazard functions associated with the treatment groups (CC-5013/Dex:Placebo/Dex)|||1.143|0.651|0.302
72555406|NCT00424047|144642361|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|Probability from Wilcoxon rank sum test||||||<0.001
72555407|NCT00424047|144642362|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|Probability from Wilcoxon rank sum test||||||<0.001
72555408|NCT00424047|144642365|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.558||||0.021|TWO_SIDED|95.0|0.338|0.921|||Log Rank|The p-value is based on an unstratified log rank test of survival curve differences between the treatment groups|Based on a proportional hazards model comparing the hazard functions associated with the treatment groups (lenalidomide/dexamethasone : placebo/dexamethasone).|||0.921|0.338|0.021
72555409|NCT00424047|144642366|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.362|||<|0.001|TWO_SIDED|95.0|0.27|0.478||The p-value is based on an unstratified log rank test of survival curve differences between the treatment groups.|Log Rank||Based on a proportional hazards model comparing the hazard functions associated with the treatment groups (CC-5013/Dex:Placebo/Dex)|||0.478|0.27|<0.001
72555410|NCT00424047|144642367|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.166||||0.271|TWO_SIDED|95.0|0.887|1.532||The p-value is based on an unstratified log rank test of survival curve differences between the treatment groups.|Log Rank||Based on a proportional hazards model comparing the hazard functions associated with the treatment groups (lenalidomide/dexamethasone: placebo/dexamethasone)|||1.532|0.887|0.271
72555411|NCT00424047|144642368|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.135||||0.359|TWO_SIDED|95.0|0.866|1.486||The p-value is based on an unstratified log rank test of survival curve differences between the treatment groups.|Log Rank||Based on a proportional hazards model comparing the hazard functions associated with the treatment groups (CC-5013/Dex:Placebo/Dex)|||1.486|0.866|0.359
72555412|NCT00424047|144642369|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.619||||0.032|TWO_SIDED|95.0|0.398|0.964|||Log Rank|The p-value is based on an unstratified log rank test of survival curve differences between the treatment groups.|Based on a proportional hazards model comparing the hazard functions associated with the treatment groups (CC-5013/Dex:Placebo/Dex)|||0.964|0.398|0.032
72555413|NCT03100344|144642372|OTHER|mixed-effect model for repeated measures (MMRM)|mean difference of percentage changes|-13.6||||0.051|TWO_SIDED|95.0|-27.3|0.0|||Kenward-Rogers|||||0.0|-27.3|0.051
72555414|NCT03100344|144642372|OTHER|mixed-effect model for repeated measures (MMRM)|mean difference of percentage changes|-16.7||||0.016|TWO_SIDED|95.0|-30.2|-3.2|||Kenward Roger|||||-3.2|-30.2|0.016
72555415|NCT03100344|144642372|OTHER|mixed-effect model for repeated measures (MMRM)|mean difference of percentage changes|-6.8||||0.322|TWO_SIDED|95.0|-20.5|6.8|||Kenward Roger|||||6.8|-20.5|0.322
72555416|NCT03100344|144642373|SUPERIORITY||Mean Difference (Final Values)|18.9||||0.034|TWO_SIDED|95.0|2.0|35.8|||Cochran-Mantel-Haenszel|||||35.8|2.0|0.034
72555417|NCT03100344|144642373|SUPERIORITY||Mean Difference (Final Values)|31.4|||<|0.001|TWO_SIDED|95.0|14.7|48.2|||Cochran-Mantel-Haenszel|||||48.2|14.7|<0.001
72555418|NCT03100344|144642373|SUPERIORITY||Mean Difference (Final Values)|12.2||||0.154|TWO_SIDED|95.0|-4.2|28.6|||Cochran-Mantel-Haenszel|||||28.6|-4.2|0.154
72555419|NCT03100344|144642374|SUPERIORITY||Mean Difference (Final Values)|10.9||||0.062|TWO_SIDED|95.0|-0.4|22.2|||Cochran-Mantel-Haenszel|||Week 1||22.2|-0.4|0.062
72555420|NCT03100344|144642374|SUPERIORITY||Mean Difference (Final Values)|12.2||||0.042|TWO_SIDED|95.0|0.8|23.6|||Cochran-Mantel-Haenszel|||Week 1||23.6|0.8|0.042
72555421|NCT03100344|144642374|SUPERIORITY||Mean Difference (Final Values)|5.2||||0.307|TWO_SIDED|95.0|-4.7|15.0|||Cochran-Mantel-Haenszel|||Week 1||15.0|-4.7|0.307
72555422|NCT03100344|144642374|SUPERIORITY||Mean Difference (Final Values)|24.0||||0.003|TWO_SIDED|95.0|9.3|38.7|||Cochran-Mantel-Haenszel|||Week 2||38.7|9.3|0.003
72504466|NCT00984659|144539576|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Analysis of covariance (ANCOVA) adjusted for age, gender, and percent predicted Forced Expiratory volume in one second (FEV1) at Screening.|ANCOVA|||||||<0.001
72504467|NCT00984659|144539577|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||ANCOVA adjusted for age, gender, and percent predicted FEV1 at Screening.|ANCOVA|||||||<0.001
72504468|NCT00984659|144539578|SUPERIORITY_OR_OTHER|||||||0.008||95.0||||ANCOVA adjusted for age, gender, and percent predicted FEV1 at Screening|ANCOVA|||||||0.008
72555423|NCT03100344|144642374|SUPERIORITY||Mean Difference (Final Values)|26.2||||0.001|TWO_SIDED|95.0|11.4|40.9|||Cochran-Mantel-Haenszel|||Week 2||40.9|11.4|0.001
72555424|NCT03100344|144642374|SUPERIORITY||Mean Difference (Final Values)|19.0||||0.011|TWO_SIDED|95.0|4.9|33.1|||Cochran-Mantel-Haenszel|||Week 2||33.1|4.9|0.011
72555425|NCT03100344|144642374|SUPERIORITY||Mean Difference (Final Values)|27.6|||<|0.001|TWO_SIDED|95.0|13.5|41.7|||Cochran-Mantel-Haenszel|||Week 4||41.7|13.5|<0.001
72555426|NCT03100344|144642374|SUPERIORITY||Mean Difference (Final Values)|40.3|||<|0.001|TWO_SIDED|95.0|25.7|54.8|||Cochran-Mantel-Haenszel|||Week 4||54.8|25.7|<0.001
72555427|NCT03100344|144642374|SUPERIORITY||Mean Difference (Final Values)|31.6|||<|0.001|TWO_SIDED|95.0|17.4|45.8|||Cochran-Mantel-Haenszel|||Week 4||45.8|17.4|<0.001
72555428|NCT03100344|144642374|SUPERIORITY||Mean Difference (Final Values)|20.6||||0.018|TWO_SIDED|95.0|4.2|37.1|||Cochran-Mantel-Haenszel|||Week 8||37.1|4.2|0.018
72555429|NCT03100344|144642374|SUPERIORITY||Mean Difference (Final Values)|43.7|||<|1|TWO_SIDED|95.0|27.6|59.9|||Cochran-Mantel-Haenszel|||Week 8||59.9|27.6|<0001
72555430|NCT03100344|144642374|SUPERIORITY||Mean Difference (Final Values)|26.1||||0.003|TWO_SIDED|95.0|9.7|42.6|||Cochran-Mantel-Haenszel|||Week 8||42.6|9.7|0.003
72555431|NCT03100344|144642374|SUPERIORITY||Mean Difference (Final Values)|24.4||||0.007|TWO_SIDED|95.0|7.3|41.4|||Cochran-Mantel-Haenszel|||Week 12||41.4|7.3|0.007
72555432|NCT03100344|144642374|SUPERIORITY||Mean Difference (Final Values)|43.6|||<|0.001|TWO_SIDED|95.0|27.4|59.9|||Cochran-Mantel-Haenszel|||Week 12||59.9|27.4|<0.001
72555433|NCT03100344|144642374|SUPERIORITY||Mean Difference (Final Values)|19.1||||0.03|TWO_SIDED|95.0|2.4|35.9|||Cochran-Mantel-Haenszel|||Week 12||35.9|2.4|0.030
72555434|NCT03100344|144642374|SUPERIORITY||Mean Difference (Final Values)|33.3|||<|0.001|TWO_SIDED|95.0|16.4|50.2|||Cochran-Mantel-Haenszel|||Week 16||50.2|16.4|<0.001
72555435|NCT03100344|144642374|SUPERIORITY||Mean Difference (Final Values)|47.2|||<|0.001|TWO_SIDED|95.0|31.2|63.2|||Cochran-Mantel-Haenszel|||Week 16||63.2|31.2|<0.001
72555436|NCT03100344|144642374|SUPERIORITY||Mean Difference (Final Values)|22.8||||0.01|TWO_SIDED|95.0|6.1|39.4|||Cochran-Mantel-Haenszel|||Week 16||39.4|6.1|0.010
72555437|NCT03100344|144642374|SUPERIORITY||Mean Difference (Final Values)|26.3||||0.004|TWO_SIDED|95.0|9.2|43.5|||Cochran-Mantel-Haenszel|||Week 20||43.5|9.2|0.004
72555438|NCT03100344|144642374|SUPERIORITY||Mean Difference (Final Values)|36.7|||<|0.001|TWO_SIDED|95.0|20.1|53.3|||Cochran-Mantel-Haenszel|||Week 20||53.3|20.1|<0.001
72555439|NCT03100344|144642374|SUPERIORITY||Mean Difference (Final Values)|24.5||||0.007|TWO_SIDED|95.0|7.6|41.4|||Cochran-Mantel-Haenszel|||Week 20||41.4|7.6|0.007
72555440|NCT03100344|144642374|SUPERIORITY||Mean Difference (Final Values)|20.9||||0.022|TWO_SIDED|95.0|3.6|38.1|||Cochran-Mantel-Haenszel|||Week 24||38.1|3.6|0.022
72555441|NCT03100344|144642374|SUPERIORITY||Mean Difference (Final Values)|24.3||||0.007|TWO_SIDED|95.0|7.4|41.3|||Cochran-Mantel-Haenszel|||Week 24||41.3|7.4|0.007
72555442|NCT03100344|144642374|SUPERIORITY||Mean Difference (Final Values)|17.4||||0.05|TWO_SIDED|95.0|0.4|34.4|||Cochran-Mantel-Haenszel|||Week 24||34.4|0.4|0.050
72555443|NCT03100344|144642375|OTHER|mixed-effect model for repeated measures|mean difference of percentage changes|-14.4||||0.017|TWO_SIDED|95.0|-26.2|-2.7|||Kenward Roger|||||-2.7|-26.2|0.017
72555444|NCT03100344|144642375|OTHER|mixed-effect model for repeated measures|mean difference of percentage changes|-11.3||||0.058|TWO_SIDED|95.0|-23.1|0.4|||Kenward Roger|||||0.4|-23.1|0.058
72555445|NCT03100344|144642375|OTHER|mixed-effect model for repeated measures|mean difference of percentage changes|-20.0|||<|0.001|TWO_SIDED|95.0|-31.6|-8.3|||Kenward Roger|||||-8.3|-31.6|<0.001
72555446|NCT03100344|144642376|OTHER|mixed-effect model for repeated measures|mean difference of absolute changes|-9.6||||0.016|TWO_SIDED|95.0|-17.5|-1.8|||Kenward Roger|||||-1.8|-17.5|0.016
72555447|NCT03100344|144642376|OTHER|mixed-effect model for repeated measures|mean difference of absolute changes|-12.8||||0.001|TWO_SIDED|95.0|-20.6|-5.1|||Kenward Roger|||||-5.1|-20.6|0.001
72555448|NCT03100344|144642376|OTHER|mixed-effect model for repeated measures|mean difference of absolute changes|-7.6||||0.058|TWO_SIDED|95.0|-15.4|0.3|||Kenward Roger|||||0.3|-15.4|0.058
72555449|NCT03100344|144642377|OTHER|mixed-effect model for repeated measures|mean difference of percentage changes|-24.5|||<|0.001|TWO_SIDED|95.0|-37.8|-11.2|||Kenward Roger|||||-11.2|-37.8|<0.001
72555450|NCT03100344|144642377|OTHER|mixed-effect model for repeated measures|mean difference of percentage changes|-31.7|||<|0.001|TWO_SIDED|95.0|-44.9|-18.6|||Kenward Roger|||||-18.6|-44.9|<0.001
72555451|NCT03100344|144642377|OTHER|mixed-effect model for repeated measures|mean difference of percentage changes|-25.1|||<|0.001|TWO_SIDED|95.0|-38.4|-11.8|||Kenward Roger|||||-11.8|-38.4|<0.001
72555452|NCT03100344|144642378|OTHER|mixed-effect model for repeated measures|mean difference of absolute changes|-2.0|||<|0.001|TWO_SIDED|95.0|-3.1|-1.0|||Kenward Roger|||||-1.0|-3.1|<0.001
72555453|NCT03100344|144642378|OTHER|mixed-effect model for repeated measures|mean difference of absolute changes|-2.3|||<|0.001|TWO_SIDED|95.0|-3.4|-1.3|||Kenward Roger|||||-1.3|-3.4|<0.001
72555454|NCT03100344|144642378|OTHER|mixed-effect model for repeated measures|mean difference of absolute changes|-1.9|||<|0.001|TWO_SIDED|95.0|-3.0|-0.9|||Kenward Roger|||||-0.9|-3.0|<0.001
72555455|NCT03100344|144642379|OTHER||Mean Difference (Final Values)|0.1||||0.97|TWO_SIDED|95.0|-4.9|5.1|||Cochran-Mantel-Haenszel|||At week 1||5.1|-4.9|0.970
72555456|NCT03100344|144642379|OTHER||Mean Difference (Final Values)|1.7||||0.574|TWO_SIDED|95.0|-4.1|7.5|||Cochran-Mantel-Haenszel|||At week 1||7.5|-4.1|0.574
72555457|NCT03100344|144642379|OTHER||Mean Difference (Final Values)|-1.8||||0.311|TWO_SIDED|95.0|-5.2|1.7|||Cochran-Mantel-Haenszel|||At week 1||1.7|-5.2|0.311
72555458|NCT03100344|144642379|OTHER||Mean Difference (Final Values)|4.2||||0.598|TWO_SIDED|95.0|-11.3|19.8|||Cochran-Mantel-Haenszel|||At week 24||19.8|-11.3|0.598
72555459|NCT03100344|144642379|OTHER||Mean Difference (Final Values)|15.5||||0.066|TWO_SIDED|95.0|-0.4|31.4|||Cochran-Mantel-Haenszel|||At week 24||31.4|-0.4|0.066
72555460|NCT03100344|144642379|OTHER||Mean Difference (Final Values)|1.7||||0.826|TWO_SIDED|95.0|-13.5|16.9|||Cochran-Mantel-Haenszel|||At week 24||16.9|-13.5|0.826
72555461|NCT03100344|144642379|SUPERIORITY||Mean Difference (Final Values)|-1.8||||0.558|TWO_SIDED|95.0|-7.7|4.1|||Cochran-Mantel-Haenszel|||Week 2||4.1|-7.7|0.558
72555462|NCT03100344|144642379|SUPERIORITY||Mean Difference (Final Values)|3.4||||0.413|TWO_SIDED|95.0|-4.7|11.6|||Cochran-Mantel-Haenszel|||Week 2||11.6|-4.7|0.413
72555463|NCT03100344|144642379|SUPERIORITY||Mean Difference (Final Values)|-1.8||||0.543|TWO_SIDED|95.0|-7.7|4.0|||Cochran-Mantel-Haenszel|||Week 2||4.0|-7.7|0.543
72493709|NCT02889796|144516553|SUPERIORITY||Difference in Response Rates|6.3||||0.069|TWO_SIDED|95.0|-1.0|13.6||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg vs Adalimumab at Week 12||13.6|-1.0|0.069
72493710|NCT02889796|144516553|SUPERIORITY||Difference in Response Rates|-4.6||||0.18|TWO_SIDED|95.0|-11.8|2.6||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg vs Adalimumab at Week 12||2.6|-11.8|0.18
72493711|NCT02889796|144516554|SUPERIORITY||Least Squares Mean Difference|3.7|STANDARD_ERROR_OF_MEAN|0.47|<|0.001|TWO_SIDED|95.0|2.8|4.6||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||4.6|2.8|<0.001
72493712|NCT02889796|144516554|SUPERIORITY||Least Squares Mean Difference|3.1|STANDARD_ERROR_OF_MEAN|0.46|<|0.001|TWO_SIDED|95.0|2.2|4.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||4.0|2.2|<0.001
72493713|NCT02889796|144516555|SUPERIORITY||Least Squares Mean Difference|2.8|STANDARD_ERROR_OF_MEAN|0.56|<|0.001|TWO_SIDED|95.0|1.7|3.9||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||3.9|1.7|<0.001
72493714|NCT02889796|144516555|SUPERIORITY||Least Squares Mean Difference|2.6|STANDARD_ERROR_OF_MEAN|0.55|<|0.001|TWO_SIDED|95.0|1.5|3.7||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||3.7|1.5|<0.001
72555464|NCT03100344|144642379|SUPERIORITY||Mean Difference (Final Values)|-1.7||||0.583|TWO_SIDED|95.0|-7.6|4.2|||Cochran-Mantel-Haenszel|||Week 4||4.2|-7.6|0.583
72555465|NCT03100344|144642379|SUPERIORITY||Mean Difference (Final Values)|12.2||||0.028|TWO_SIDED|95.0|1.8|22.5|||Cochran-Mantel-Haenszel|||Week 4||22.5|1.8|0.028
72555466|NCT03100344|144642379|SUPERIORITY||Mean Difference (Final Values)|8.7||||0.087|TWO_SIDED|95.0|-0.9|18.3|||Cochran-Mantel-Haenszel|||Week 4||18.3|-0.9|0.087
72618297|NCT00286455|144767660|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.013||||0.949|TWO_SIDED|95.0|-0.391|0.417||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.417|-0.391|0.949
72618298|NCT00286455|144767661|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.03||||0.886|TWO_SIDED|95.0|-0.44|0.38||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.380|-0.440|0.886
72493715|NCT02889796|144516556|SUPERIORITY||Difference in Response Rates|8.0|||<|0.001|TWO_SIDED|95.0|5.1|10.9||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg vs Placebo at Week 2||10.9|5.1|<0.001
72493716|NCT02889796|144516556|SUPERIORITY||Difference in Response Rates|4.8|||<|0.001|TWO_SIDED|95.0|2.3|7.3||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg vs Placebo at Week 2||7.3|2.3|<0.001
72493717|NCT02889796|144516556|SUPERIORITY||Difference in Response Rates|16.4|||<|0.001|TWO_SIDED|95.0|11.9|20.9||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg vs Placebo at Week 4||20.9|11.9|<0.001
72493718|NCT02889796|144516556|SUPERIORITY||Difference in Response Rates|7.0|||<|0.001|TWO_SIDED|95.0|3.1|10.9||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg vs Placebo at Week 4||10.9|3.1|<0.001
72493719|NCT02889796|144516556|SUPERIORITY||Difference in Response Rates|27.4|||<|0.001|TWO_SIDED|95.0|21.4|33.3||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg vs Placebo at Week 12||33.3|21.4|<0.001
72493720|NCT02889796|144516556|SUPERIORITY||Difference in Response Rates|16.7|||<|0.001|TWO_SIDED|95.0|10.9|22.5||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg vs Placebo at Week 12||22.5|10.9|<0.001
72555467|NCT03100344|144642379|SUPERIORITY||Mean Difference (Final Values)|1.9||||0.632|TWO_SIDED|95.0|-5.6|9.4|||Cochran-Mantel-Haenszel|||Week 8||9.4|-5.6|0.632
72555468|NCT03100344|144642379|SUPERIORITY||Mean Difference (Final Values)|14.0||||0.016|TWO_SIDED|95.0|3.1|24.8|||Cochran-Mantel-Haenszel|||Week 8||24.8|3.1|0.016
72555469|NCT03100344|144642379|SUPERIORITY||Mean Difference (Final Values)|15.8||||0.009|TWO_SIDED|95.0|4.5|27.0|||Cochran-Mantel-Haenszel|||Week 8||27.0|4.5|0.009
72555470|NCT03100344|144642379|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.974|TWO_SIDED|95.0|-11.2|11.6|||Cochran-Mantel-Haenszel|||Week 12||11.6|-11.2|0.974
72555471|NCT03100344|144642379|SUPERIORITY||Mean Difference (Final Values)|15.6||||0.031|TWO_SIDED|95.0|1.8|29.3|||Cochran-Mantel-Haenszel|||Week 12||29.3|1.8|0.031
72555472|NCT03100344|144642379|SUPERIORITY||Mean Difference (Final Values)|13.9||||0.032|TWO_SIDED|95.0|-0.3|28.2|||Cochran-Mantel-Haenszel|||Week 12||28.2|-0.3|0.032
72555473|NCT03100344|144642379|SUPERIORITY||Mean Difference (Final Values)|4.0||||0.553|TWO_SIDED|95.0|-9.0|16.9|||Cochran-Mantel-Haenszel|||Week 16||16.9|-9.0|0.553
72555474|NCT03100344|144642379|SUPERIORITY||Mean Difference (Final Values)|20.9||||0.008|TWO_SIDED|95.0|6.1|35.8|||Cochran-Mantel-Haenszel|||Week 16||35.8|6.1|0.008
72555475|NCT03100344|144642379|SUPERIORITY||Mean Difference (Final Values)|13.9||||0.061|TWO_SIDED|95.0|-0.3|28.2|||Cochran-Mantel-Haenszel|||Week 16||28.2|-0.3|0.061
72555476|NCT03100344|144642379|SUPERIORITY||Mean Difference (Final Values)|4.0||||0.585|TWO_SIDED|95.0|-10.1|18.0|||Cochran-Mantel-Haenszel|||Week 20||18.0|-10.1|0.585
72555477|NCT03100344|144642379|SUPERIORITY||Mean Difference (Final Values)|17.4||||0.032|TWO_SIDED|95.0|2.0|32.8|||Cochran-Mantel-Haenszel|||Week 20||32.8|2.0|0.032
72555478|NCT03100344|144642379|SUPERIORITY||Mean Difference (Final Values)|8.6||||0.254|TWO_SIDED|95.0|-5.9|23.1|||Cochran-Mantel-Haenszel|||Week 20||23.1|-5.9|0.254
72555479|NCT03100344|144642380|SUPERIORITY||Mean Difference (Final Values)|3.8||||0.487|TWO_SIDED|95.0|-6.8|14.3|||Cochran-Mantel-Haenszel|||Week 1||14.3|-6.8|0.487
72555480|NCT03100344|144642380|SUPERIORITY||Mean Difference (Final Values)|14.0||||0.033|TWO_SIDED|95.0|1.6|26.5|||Cochran-Mantel-Haenszel|||Week 1||26.5|1.6|0.033
72555481|NCT03100344|144642380|SUPERIORITY||Mean Difference (Final Values)|12.0||||0.053|TWO_SIDED|95.0|0.2|23.8|||Cochran-Mantel-Haenszel|||Week 1||23.8|0.2|0.053
72555482|NCT03100344|144642380|SUPERIORITY||Mean Difference (Final Values)|18.5||||0.021|TWO_SIDED|95.0|3.2|33.8|||Cochran-Mantel-Haenszel|||Week 2||33.8|3.2|0.021
72555483|NCT03100344|144642380|SUPERIORITY||Mean Difference (Final Values)|17.4||||0.027|TWO_SIDED|95.0|2.4|32.3|||Cochran-Mantel-Haenszel|||Week 2||32.3|2.4|0.027
72555484|NCT03100344|144642380|SUPERIORITY||Mean Difference (Final Values)|22.7||||0.006|TWO_SIDED|95.0|7.3|38.1|||Cochran-Mantel-Haenszel|||Week 2||38.1|7.3|0.006
72555485|NCT03100344|144642380|SUPERIORITY||Mean Difference (Final Values)|15.2||||0.086|TWO_SIDED|95.0|-1.7|32.2|||Cochran-Mantel-Haenszel|||Week 4||32.2|-1.7|0.086
72555486|NCT03100344|144642380|SUPERIORITY||Mean Difference (Final Values)|26.2||||0.004|TWO_SIDED|95.0|9.3|43.1|||Cochran-Mantel-Haenszel|||Week 4||43.1|9.3|0.004
72555487|NCT03100344|144642380|SUPERIORITY||Mean Difference (Final Values)|17.3||||0.05|TWO_SIDED|95.0|0.5|34.2|||Cochran-Mantel-Haenszel|||Week 4||34.2|0.5|0.050
72555488|NCT03100344|144642380|SUPERIORITY||Mean Difference (Final Values)|20.7||||0.023|TWO_SIDED|95.0|3.3|38.1|||Cochran-Mantel-Haenszel|||Week 8||38.1|3.3|0.023
72555489|NCT03100344|144642380|SUPERIORITY||Mean Difference (Final Values)|27.9||||0.002|TWO_SIDED|95.0|10.7|45.0|||Cochran-Mantel-Haenszel|||Week 8||45.0|10.7|0.002
72555490|NCT03100344|144642380|SUPERIORITY||Mean Difference (Final Values)|27.9||||0.002|TWO_SIDED|95.0|10.7|45.0|||Cochran-Mantel-Haenszel|||Week 8||45.0|10.7|0.002
72555491|NCT03100344|144642380|SUPERIORITY||Mean Difference (Final Values)|19.3||||0.041|TWO_SIDED|95.0|1.3|37.3|||Cochran-Mantel-Haenszel|||Week 12||37.3|1.3|0.041
72555492|NCT03100344|144642380|SUPERIORITY||Mean Difference (Final Values)|27.9||||0.003|TWO_SIDED|95.0|10.4|45.4|||Cochran-Mantel-Haenszel|||Week 12||45.4|10.4|0.003
72555493|NCT03100344|144642380|SUPERIORITY||Mean Difference (Final Values)|17.3||||0.063|TWO_SIDED|95.0|-0.5|35.2|||Cochran-Mantel-Haenszel|||Week 12||35.2|-0.5|0.063
72555494|NCT03100344|144642380|SUPERIORITY||Mean Difference (Final Values)|17.6||||0.064|TWO_SIDED|95.0|-0.4|35.6|||Cochran-Mantel-Haenszel|||Week 16||35.6|-0.4|0.064
72555495|NCT03100344|144642380|SUPERIORITY||Mean Difference (Final Values)|22.6||||0.016|TWO_SIDED|95.0|4.9|40.3|||Cochran-Mantel-Haenszel|||Week 16||40.3|4.9|0.016
72555496|NCT03100344|144642380|SUPERIORITY||Mean Difference (Final Values)|19.1||||0.041|TWO_SIDED|95.0|1.3|36.9|||Cochran-Mantel-Haenszel|||Week 16||36.9|1.3|0.041
72555497|NCT03100344|144642380|SUPERIORITY||Mean Difference (Final Values)|17.6||||0.064|TWO_SIDED|95.0|-0.4|35.6|||Cochran-Mantel-Haenszel|||Week 20||35.6|-0.4|0.064
72555498|NCT03100344|144642380|SUPERIORITY||Mean Difference (Final Values)|26.0||||0.005|TWO_SIDED|95.0|8.6|43.4|||Cochran-Mantel-Haenszel|||Week 20||43.4|8.6|0.005
72555499|NCT03100344|144642380|SUPERIORITY||Mean Difference (Final Values)|17.2||||0.064|TWO_SIDED|95.0|-0.6|35.0|||Cochran-Mantel-Haenszel|||Week 20||35.0|-0.6|0.064
72555500|NCT03100344|144642380|SUPERIORITY||Mean Difference (Final Values)|15.9||||0.094|TWO_SIDED|95.0|-2.0|33.8|||Cochran-Mantel-Haenszel|||Week 24||33.8|-2.0|0.094
72555501|NCT03100344|144642380|SUPERIORITY||Mean Difference (Final Values)|22.4||||0.014|TWO_SIDED|95.0|5.1|39.6|||Cochran-Mantel-Haenszel|||Week 24||39.6|5.1|0.014
72555502|NCT03100344|144642380|SUPERIORITY||Mean Difference (Final Values)|10.2||||0.273|TWO_SIDED|95.0|-7.7|28.0|||Cochran-Mantel-Haenszel|||Week 24||28.0|-7.7|0.273
72555503|NCT03100344|144642381|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.979|TWO_SIDED|95.0|-6.8|7.0|||Cochran-Mantel-Haenszel|||Week 1||7.0|-6.8|0.979
72555504|NCT03100344|144642381|SUPERIORITY||Mean Difference (Final Values)|1.6||||0.668|TWO_SIDED|95.0|-5.8|9.0|||Cochran-Mantel-Haenszel|||Week 1||9.0|-5.8|0.668
72555505|NCT03100344|144642381|SUPERIORITY||Mean Difference (Final Values)|1.7||||0.658|TWO_SIDED|95.0|-5.8|9.2|||Cochran-Mantel-Haenszel|||Week 1||9.2|-5.8|0.658
72555506|NCT03100344|144642381|SUPERIORITY||Mean Difference (Final Values)|2.1||||0.69|TWO_SIDED|95.0|-8.0|12.2|||Cochran-Mantel-Haenszel|||Week 2||12.2|-8.0|0.690
72555507|NCT03100344|144642381|SUPERIORITY||Mean Difference (Final Values)|3.4||||0.521|TWO_SIDED|95.0|-6.9|13.7|||Cochran-Mantel-Haenszel|||Week 2||13.7|-6.9|0.521
72555508|NCT03100344|144642381|SUPERIORITY||Mean Difference (Final Values)|14.0||||0.033|TWO_SIDED|95.0|1.5|26.5|||Cochran-Mantel-Haenszel|||Week 2||26.5|1.5|0.033
72555509|NCT03100344|144642381|SUPERIORITY||Mean Difference (Final Values)|7.4||||0.172|TWO_SIDED|95.0|-3.1|18.0|||Cochran-Mantel-Haenszel|||Week 4||18.0|-3.1|0.172
72555510|NCT03100344|144642381|SUPERIORITY||Mean Difference (Final Values)|15.7||||0.014|TWO_SIDED|95.0|3.7|27.7|||Cochran-Mantel-Haenszel|||Week 4||27.7|3.7|0.014
72555511|NCT03100344|144642381|SUPERIORITY||Mean Difference (Final Values)|21.0||||0.002|TWO_SIDED|95.0|8.2|33.9|||Cochran-Mantel-Haenszel|||Week 4||33.9|8.2|0.002
72555512|NCT03100344|144642381|SUPERIORITY||Mean Difference (Final Values)|5.6||||0.404|TWO_SIDED|95.0|-7.5|18.8|||Cochran-Mantel-Haenszel|||Week 8||18.8|-7.5|0.404
72555513|NCT03100344|144642381|SUPERIORITY||Mean Difference (Final Values)|24.5||||0.003|TWO_SIDED|95.0|9.4|39.6|||Cochran-Mantel-Haenszel|||Week 8||39.6|9.4|0.003
72555514|NCT03100344|144642381|SUPERIORITY||Mean Difference (Final Values)|14.1||||0.059|TWO_SIDED|95.0|-0.1|28.2|||Cochran-Mantel-Haenszel|||Week 8||28.2|-0.1|0.059
72555515|NCT03100344|144642381|SUPERIORITY||Mean Difference (Final Values)|9.7||||0.222|TWO_SIDED|95.0|-5.6|25.0|||Cochran-Mantel-Haenszel|||Week 12||25.0|-5.6|0.222
72555516|NCT03100344|144642381|SUPERIORITY||Mean Difference (Final Values)|26.1||||0.003|TWO_SIDED|95.0|10.0|42.3|||Cochran-Mantel-Haenszel|||Week 12||42.3|10.0|0.003
72555517|NCT03100344|144642381|SUPERIORITY||Mean Difference (Final Values)|19.1||||0.22|TWO_SIDED|95.0|3.3|35.0|||Cochran-Mantel-Haenszel|||Week 12||35.0|3.3|0.22
72555518|NCT03100344|144642381|SUPERIORITY||Mean Difference (Final Values)|13.3||||0.111|TWO_SIDED|95.0|-2.8|29.3|||Cochran-Mantel-Haenszel|||Week 16||29.3|-2.8|0.111
72555519|NCT03100344|144642381|SUPERIORITY||Mean Difference (Final Values)|29.6|||<|0.001|TWO_SIDED|95.0|13.2|46.0|||Cochran-Mantel-Haenszel|||Week 16||46.0|13.2|<0.001
72555520|NCT03100344|144642381|SUPERIORITY||Mean Difference (Final Values)|17.4||||0.04|TWO_SIDED|95.0|1.3|33.6|||Cochran-Mantel-Haenszel|||Week 16||33.6|1.3|0.040
72555521|NCT03100344|144642381|SUPERIORITY||Mean Difference (Final Values)|10.1||||0.262|TWO_SIDED|95.0|-7.3|27.4|||Cochran-Mantel-Haenszel|||Week 20||27.4|-7.3|0.262
72555522|NCT03100344|144642381|SUPERIORITY||Mean Difference (Final Values)|8.7||||0.327|TWO_SIDED|95.0|-8.4|25.7|||Cochran-Mantel-Haenszel|||Week 20||25.7|-8.4|0.327
72618299|NCT00286455|144767661|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.097||||0.645|TWO_SIDED|95.0|-0.51|0.317||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.317|-0.510|0.645
72555523|NCT03100344|144642381|SUPERIORITY||Mean Difference (Final Values)|15.7||||0.083|TWO_SIDED|95.0|-1.7|33.1|||Cochran-Mantel-Haenszel|||Week 20||33.1|-1.7|0.083
72555524|NCT03100344|144642381|SUPERIORITY||Mean Difference (Final Values)|10.1||||0.255|TWO_SIDED|95.0|-7.0|27.2|||Cochran-Mantel-Haenszel|||Week 24||27.2|-7.0|0.255
72555525|NCT03100344|144642381|SUPERIORITY||Mean Difference (Final Values)|19.0||||0.034|TWO_SIDED|95.0|2.2|35.9|||Cochran-Mantel-Haenszel|||Week 24||35.9|2.2|0.034
72555526|NCT03100344|144642381|SUPERIORITY||Mean Difference (Final Values)|17.4||||0.053|TWO_SIDED|95.0|0.3|34.6|||Cochran-Mantel-Haenszel|||Week 24||34.6|0.3|0.053
72555527|NCT03100344|144642382|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.97|TWO_SIDED|95.0|-4.9|5.1|||Cochran-Mantel-Haenszel|||Week 1||5.1|-4.9|0.970
72555528|NCT03100344|144642382|SUPERIORITY||Mean Difference (Final Values)|1.7||||0.574|TWO_SIDED|95.0|-4.1|7.5|||Cochran-Mantel-Haenszel|||Week 1||7.5|-4.1|0.574
72555529|NCT03100344|144642382|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.985|TWO_SIDED|95.0|-4.8|4.8|||Cochran-Mantel-Haenszel|||Week 1||4.8|-4.8|0.985
72555530|NCT03100344|144642382|SUPERIORITY||Mean Difference (Final Values)|-3.6||||0.154|TWO_SIDED|95.0|-8.4|1.2|||Cochran-Mantel-Haenszel|||Week 2||1.2|-8.4|0.154
72555531|NCT03100344|144642382|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.978|TWO_SIDED|95.0|-6.8|6.6|||Cochran-Mantel-Haenszel|||Week 2||6.6|-6.8|0.978
72555532|NCT03100344|144642382|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.978|TWO_SIDED|95.0|-6.8|6.6|||Cochran-Mantel-Haenszel|||Week 2||6.6|-6.8|0.978
72555533|NCT03100344|144642382|SUPERIORITY||Mean Difference (Final Values)|-1.6||||0.602|TWO_SIDED|95.0|-7.5|4.3|||Cochran-Mantel-Haenszel|||Week 4||4.3|-7.5|0.602
72555534|NCT03100344|144642382|SUPERIORITY||Mean Difference (Final Values)|3.4||||0.413|TWO_SIDED|95.0|-4.5|11.4|||Cochran-Mantel-Haenszel|||Week 4||11.4|-4.5|0.413
72555535|NCT03100344|144642382|SUPERIORITY||Mean Difference (Final Values)|1.7||||0.658|TWO_SIDED|95.0|-5.7|9.1|||Cochran-Mantel-Haenszel|||Week 4||9.1|-5.7|0.658
72555536|NCT03100344|144642382|SUPERIORITY||Mean Difference (Final Values)|3.6||||0.307|TWO_SIDED|95.0|-3.2|10.3|||Cochran-Mantel-Haenszel|||Week 8||10.3|-3.2|0.307
72555537|NCT03100344|144642382|SUPERIORITY||Mean Difference (Final Values)|17.3||||0.002|TWO_SIDED|95.0|6.9|27.8|||Cochran-Mantel-Haenszel|||Week 8||27.8|6.9|0.002
72555538|NCT03100344|144642382|SUPERIORITY||Mean Difference (Final Values)|8.7||||0.054|TWO_SIDED|95.0|0.1|17.4|||Cochran-Mantel-Haenszel|||Week 8||17.4|0.1|0.054
72555539|NCT03100344|144642382|SUPERIORITY||Mean Difference (Final Values)|5.6||||0.325|TWO_SIDED|95.0|-5.4|16.5|||Cochran-Mantel-Haenszel|||Week 12||16.5|-5.4|0.325
72555540|NCT03100344|144642382|SUPERIORITY||Mean Difference (Final Values)|15.6||||0.019|TWO_SIDED|95.0|3.1|28.1|||Cochran-Mantel-Haenszel|||Week 12||28.1|3.1|0.019
72555541|NCT03100344|144642382|SUPERIORITY||Mean Difference (Final Values)|17.5||||0.011|TWO_SIDED|95.0|4.5|30.5|||Cochran-Mantel-Haenszel|||Week 12||30.5|4.5|0.011
72555542|NCT03100344|144642382|SUPERIORITY||Mean Difference (Final Values)|9.2||||0.153|TWO_SIDED|95.0|-3.2|21.7|||Cochran-Mantel-Haenszel|||Week 16||21.7|-3.2|0.153
72555543|NCT03100344|144642382|SUPERIORITY||Mean Difference (Final Values)|24.4||||0.001|TWO_SIDED|95.0|10.3|38.4|||Cochran-Mantel-Haenszel|||Week 16||38.4|10.3|0.001
72555544|NCT03100344|144642382|SUPERIORITY||Mean Difference (Final Values)|12.2||||0.069|TWO_SIDED|95.0|-0.7|25.1|||Cochran-Mantel-Haenszel|||Week 16||25.1|-0.7|0.069
72555545|NCT03100344|144642382|SUPERIORITY||Mean Difference (Final Values)|12.9||||0.07|TWO_SIDED|95.0|-0.8|26.6|||Cochran-Mantel-Haenszel|||Week 20||26.6|-0.8|0.070
72555546|NCT03100344|144642382|SUPERIORITY||Mean Difference (Final Values)|20.9||||0.006|TWO_SIDED|95.0|6.5|35.3|||Cochran-Mantel-Haenszel|||Week 20||35.3|6.5|0.006
72555547|NCT03100344|144642382|SUPERIORITY||Mean Difference (Final Values)|14.0||||0.052|TWO_SIDED|95.0|0.3|27.7|||Cochran-Mantel-Haenszel|||Week 20||27.7|0.3|0.052
72433245|NCT04927975|144379442|SUPERIORITY|P-value calculated according to the Cochran-Mantel-Haenszel test adjusted for strata (age group \[≤ 50 and \> 50\], baseline disease severity \[T-VASI \< 15 and ≥ 15\], and status of active vitiligo \[Yes/No\])) for the comparison of two treatment groups. The calculations at each visit were based on non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19 or non-responder imputation only if there were no missing data due to COVID-19.|Response Rate Difference|9.1||||0.027|TWO_SIDED|95.0|1.0|17.2|||Cochran-Mantel-Haenszel|||Upa 22 mg Period 1 versus Placebo Period 1||17.2|1.0|0.027
72555548|NCT03100344|144642382|SUPERIORITY||Mean Difference (Final Values)|12.8||||0.069|TWO_SIDED|95.0|-0.7|26.3|||Cochran-Mantel-Haenszel|||Week 24||26.3|-0.7|0.069
72555549|NCT03100344|144642382|SUPERIORITY||Mean Difference (Final Values)|19.1||||0.011|TWO_SIDED|95.0|4.9|33.3|||Cochran-Mantel-Haenszel|||Week 24||33.3|4.9|0.011
72555550|NCT03100344|144642382|SUPERIORITY||Mean Difference (Final Values)|12.2||||0.083|TWO_SIDED|95.0|-1.3|25.7|||Cochran-Mantel-Haenszel|||Week 24||25.7|-1.3|0.083
72493721|NCT02889796|144516556|SUPERIORITY||Difference in Response Rates|24.6|||<|0.001|TWO_SIDED|95.0|18.3|31.0||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg vs Placebo at Week 24||31.0|18.3|<0.001
72493722|NCT02889796|144516556|SUPERIORITY||Difference in Response Rates|19.4|||<|0.001|TWO_SIDED|95.0|13.1|25.8||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg vs Placebo at Week 24||25.8|13.1|<0.001
72493723|NCT02889796|144516558|SUPERIORITY||Difference in Response Rates|2.3||||0.008|TWO_SIDED|95.0|0.5|4.1||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg vs Placebo at Week 2||4.1|0.5|0.008
72493724|NCT02889796|144516558|SUPERIORITY||Difference in Response Rates|0.8||||0.18|TWO_SIDED|95.0|-0.5|2.2||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg vs Placebo at Week 2||2.2|-0.5|0.18
72493725|NCT02889796|144516558|SUPERIORITY||Difference in Response Rates|7.6|||<|0.001|TWO_SIDED|95.0|4.6|10.6||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg vs Placebo at Week 4||10.6|4.6|<0.001
72493726|NCT02889796|144516558|SUPERIORITY||Difference in Response Rates|1.9||||0.067|TWO_SIDED|95.0|-0.3|4.0||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg vs Placebo at Week 4||4.0|-0.3|0.067
72493727|NCT02889796|144516558|SUPERIORITY||Difference in Response Rates|19.4|||<|0.001|TWO_SIDED|95.0|14.6|24.1||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg vs Placebo at Week 12||24.1|14.6|<0.001
72493728|NCT02889796|144516558|SUPERIORITY||Difference in Response Rates|11.8|||<|0.001|TWO_SIDED|95.0|7.5|16.2||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg vs Placebo at Week 12||16.2|7.5|<0.001
72493729|NCT02889796|144516558|SUPERIORITY||Difference in Response Rates|21.3|||<|0.001|TWO_SIDED|95.0|15.7|26.9||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg vs Placebo at Week 24||26.9|15.7|<0.001
72493730|NCT02889796|144516558|SUPERIORITY||Difference in Response Rates|14.6|||<|0.001|TWO_SIDED|95.0|9.2|20.0||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg vs Placebo at Week 24||20.0|9.2|<0.001
72493731|NCT02889796|144516560|SUPERIORITY||Difference in Response Rates|22.3|||<|0.001|TWO_SIDED|95.0|16.7|27.9||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg vs Placebo at Week 2||27.9|16.7|<0.001
72493732|NCT02889796|144516560|SUPERIORITY||Difference in Response Rates|12.6|||<|0.001|TWO_SIDED|95.0|7.2|17.9||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg vs Placebo at Week 2||17.9|7.2|<0.001
72493733|NCT02889796|144516560|SUPERIORITY||Difference in Response Rates|19.8|||<|0.001|TWO_SIDED|95.0|13.4|26.1||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg vs Placebo at Week 4||26.1|13.4|<0.001
72493734|NCT02889796|144516560|SUPERIORITY||Difference in Response Rates|13.8|||<|0.001|TWO_SIDED|95.0|7.5|20.2||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg vs Placebo at Week 4||20.2|7.5|<0.001
72493735|NCT02889796|144516560|SUPERIORITY||Difference in Response Rates|18.9|||<|0.001|TWO_SIDED|95.0|13.0|24.9||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg vs Placebo at Week 24||24.9|13.0|<0.001
72493736|NCT02889796|144516560|SUPERIORITY||Difference in Response Rates|18.6|||<|0.001|TWO_SIDED|95.0|12.6|24.5||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg vs Placebo at Week 24||24.5|12.6|<0.001
72493737|NCT02889796|144516562|SUPERIORITY||Least Squares Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.025|<|0.001|TWO_SIDED|95.0|-0.22|-0.12||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.12|-0.22|<0.001
72493738|NCT02889796|144516562|SUPERIORITY||Least Squares Mean Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.025|<|0.001|TWO_SIDED|95.0|-0.14|-0.04||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.04|-0.14|<0.001
72493739|NCT02889796|144516562|SUPERIORITY||Least Squares Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.028|<|0.001|TWO_SIDED|95.0|-0.24|-0.13||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.13|-0.24|<0.001
72374200|NCT00913458|144258763|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.5||||0.3696|TWO_SIDED|95.0|0.6|3.6|||Longitudinal statistical model|Odds ratios and p-values are based on a longitudinal statistical model with factors for treatment, visit, and interaction of treatment and visit.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.||3.6|0.6|0.3696
72374201|NCT00913458|144258764|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.17||||0.0788|TWO_SIDED|95.0|0.9|5.2|||Longitudinal statistical model|Odds ratios and p-values are based on a longitudinal statistical model with factors for treatment, visit, and interaction of treatment and visit.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.||5.2|0.9|0.0788
72374202|NCT00913458|144258764|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.57||||0.0007|TWO_SIDED|95.0|1.9|11.0|||Longitudinal statistical model|Odds ratios and p-values are based on a longitudinal statistical model with factors for treatment, visit, and interaction of treatment and visit.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.||11.0|1.9|0.0007
72374203|NCT00913458|144258764|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.1||||0.0676|TWO_SIDED|95.0|0.9|4.7|||Longitudinal statistical model|Odds ratios and p-values are based on a longitudinal statistical model with factors for treatment, visit, and interaction of treatment and visit.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.||4.7|0.9|0.0676
72374204|NCT00913458|144258765|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|7.56||||0.0548|TWO_SIDED|95.0|1.0|59.5|||Longitudinal statistical model|Odds ratios and p-values are based on a longitudinal statistical model with factors for treatment, visit, and interaction of treatment and visit.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.||59.5|1.0|0.0548
72374205|NCT00913458|144258765|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|12.18||||0.0166|TWO_SIDED|95.0|1.6|94.2|||Longitudinal statistical model|Odds ratios and p-values are based on a longitudinal statistical model with factors for treatment, visit, and interaction of treatment and visit.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.||94.2|1.6|0.0166
72374206|NCT00913458|144258765|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.61||||0.3619|TWO_SIDED|95.0|0.6|4.5|||Longitudinal statistical model|Odds ratios and p-values are based on a longitudinal statistical model with factors for treatment, visit, and interaction of treatment and visit.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.||4.5|0.6|0.3619
72374207|NCT00913458|144258766|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.23||||0.0017|TWO_SIDED|95.0|1.6|6.7|||Regression, Logistic|Odds ratios, p-values, and 95% CIs are based on a logistic regression model with treatment as the only factor.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.||6.7|1.6|0.0017
72374208|NCT00913458|144258766|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|11.05|||<|0.0001|TWO_SIDED|95.0|4.4|28.0|||Regression, Logistic|Odds ratios, p-values, and 95% CIs are based on a logistic regression model with treatment as the only factor.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.||28.0|4.4|<0.0001
72374209|NCT00913458|144258766|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.42||||0.0111|TWO_SIDED|95.0|1.3|8.8|||Regression, Logistic|Odds ratios, p-values, and 95% CIs are based on a logistic regression model with treatment as the only factor.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.||8.8|1.3|0.0111
72374210|NCT00913458|144258767|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.66||||0.0328|TWO_SIDED|95.0|-16.6|-0.7|||Longitudinal statistical model|Values are based on a longitudinal statistical model with factors for Week 52 value, treatment, visit, and interaction of treatment.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.||-0.7|-16.6|0.0328
72374211|NCT00913458|144258767|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-21.64|||<|0.0001|TWO_SIDED|95.0|-30.1|-13.2|||Longitudinal statistical model|Values are based on a longitudinal statistical model with factors for Week 52 value, treatment, visit, and interaction of treatment.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.||-13.2|-30.1|<0.0001
72374212|NCT00913458|144258767|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.98||||0.0035|TWO_SIDED|95.0|-21.5|-4.5|||Longitudinal statistical model|Values are based on a longitudinal statistical model with factors for Week 52 value, treatment, visit, and interaction of treatment.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.||-4.5|-21.5|0.0035
72374213|NCT00913458|144258768|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.36||||0.2473|TWO_SIDED|95.0|-11.8|3.1|||Longitudinal statistical model|Values are based on a longitudinal statistical model with factors for Week 52 value, treatment, visit, and interaction of treatment.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.||3.1|-11.8|0.2473
72374214|NCT00913458|144258768|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.19||||0.0016|TWO_SIDED|95.0|-21.3|-5.1|||Longitudinal statistical model|Values are based on a longitudinal statistical model with factors for Week 52 value, treatment, visit, and interaction of treatment.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.||-5.1|-21.3|0.0016
72374215|NCT00913458|144258768|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.83||||0.0348|TWO_SIDED|95.0|-17.0|-0.6|||Longitudinal statistical model|Values are based on a longitudinal statistical model with factors for Week 52 value, treatment, visit, and interaction of treatment.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.||-0.6|-17.0|0.0348
72374216|NCT00913458|144258769|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.51||||0.1248|TWO_SIDED|95.0|-12.6|1.6|||Longitudinal statistical model|Values are based on a longitudinal statistical model with factors for Week 52 value, treatment, visit, and interaction of treatment.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.||1.6|-12.6|0.1248
72374217|NCT00913458|144258769|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.14||||0.0004|TWO_SIDED|95.0|-21.8|-6.5|||Longitudinal statistical model|Values are based on a longitudinal statistical model with factors for Week 52 value, treatment, visit, and interaction of treatment.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.||-6.5|-21.8|0.0004
72493740|NCT02889796|144516562|SUPERIORITY||Least Squares Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.028|<|0.001|TWO_SIDED|95.0|-0.15|-0.04||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.04|-0.15|<0.001
72493741|NCT02889796|144516562|SUPERIORITY||Least Squares Mean Difference|-0.27|STANDARD_ERROR_OF_MEAN|0.037|<|0.001|TWO_SIDED|95.0|-0.34|-0.19||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.19|-0.34|<0.001
72493742|NCT02889796|144516562|SUPERIORITY||Least Squares Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.037|<|0.001|TWO_SIDED|95.0|-0.26|-0.11||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.11|-0.26|<0.001
72493743|NCT02889796|144516564|SUPERIORITY||Least Squares Mean Difference|-3.0|STANDARD_ERROR_OF_MEAN|0.6|<|0.001|TWO_SIDED|95.0|-4.0|-2.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-2.0|-4.0|<0.001
72555551|NCT03100344|144642383|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.97|TWO_SIDED|95.0|-4.9|5.1|||Cochran-Mantel-Haenszel|||Week 1||5.1|-4.9|0.970
72555552|NCT03100344|144642383|SUPERIORITY||Mean Difference (Final Values)|1.7||||0.574|TWO_SIDED|95.0|-4.1|7.5|||Cochran-Mantel-Haenszel|||Week 1||7.5|-4.1|0.574
72555553|NCT03100344|144642383|SUPERIORITY||Mean Difference (Final Values)|-1.8||||0.311|TWO_SIDED|95.0|-5.2|1.7|||Cochran-Mantel-Haenszel|||Week 1||1.7|-5.2|0.311
72555554|NCT03100344|144642383|SUPERIORITY||Mean Difference (Final Values)|-1.8||||0.558|TWO_SIDED|95.0|-7.7|4.1|||Cochran-Mantel-Haenszel|||Week 2||4.1|-7.7|0.558
72555555|NCT03100344|144642383|SUPERIORITY||Mean Difference (Final Values)|3.4||||0.413|TWO_SIDED|95.0|-4.7|11.6|||Cochran-Mantel-Haenszel|||Week 2||11.6|-4.7|0.413
72493744|NCT02889796|144516564|SUPERIORITY||Least Squares Mean Difference|-2.0|STANDARD_ERROR_OF_MEAN|0.6||0.01|TWO_SIDED|95.0|-3.0|0.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.0|-3.0|0.010
72493745|NCT02889796|144516564|SUPERIORITY||Least Squares Mean Difference|-3.0|STANDARD_ERROR_OF_MEAN|0.6|<|0.001|TWO_SIDED|95.0|-5.0|-2.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-2.0|-5.0|<0.001
72555556|NCT03100344|144642383|SUPERIORITY||Mean Difference (Final Values)|-1.8||||0.543|TWO_SIDED|95.0|-7.7|4.0|||Cochran-Mantel-Haenszel|||Week 2||4.0|-7.7|0.543
72555557|NCT03100344|144642383|SUPERIORITY||Mean Difference (Final Values)|-1.7||||0.583|TWO_SIDED|95.0|-7.6|4.2|||Cochran-Mantel-Haenszel|||Week 4||4.2|-7.6|0.583
72555558|NCT03100344|144642383|SUPERIORITY||Mean Difference (Final Values)|12.2||||0.028|TWO_SIDED|95.0|1.8|22.5|||Cochran-Mantel-Haenszel|||Week 4||22.5|1.8|0.028
72555559|NCT03100344|144642383|SUPERIORITY||Mean Difference (Final Values)|8.7||||0.087|TWO_SIDED|95.0|-0.9|18.3|||Cochran-Mantel-Haenszel|||Week 4||18.3|-0.9|0.087
72555560|NCT03100344|144642383|SUPERIORITY||Mean Difference (Final Values)|1.9||||0.632|TWO_SIDED|95.0|-5.6|9.4|||Cochran-Mantel-Haenszel|||Week 8||9.4|-5.6|0.632
72555561|NCT03100344|144642383|SUPERIORITY||Mean Difference (Final Values)|14.0||||0.016|TWO_SIDED|95.0|3.1|24.8|||Cochran-Mantel-Haenszel|||Week 8||24.8|3.1|0.016
72555562|NCT03100344|144642383|SUPERIORITY||Mean Difference (Final Values)|15.8||||0.009|TWO_SIDED|95.0|4.5|27.0|||Cochran-Mantel-Haenszel|||Week 8||27.0|4.5|0.009
72555563|NCT03100344|144642383|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.974|TWO_SIDED|95.0|-11.2|11.6|||Cochran-Mantel-Haenszel|||Week 12||11.6|-11.2|0.974
72555564|NCT03100344|144642383|SUPERIORITY||Mean Difference (Final Values)|15.6||||0.031|TWO_SIDED|95.0|1.8|29.3|||Cochran-Mantel-Haenszel|||Week 12||29.3|1.8|0.031
72555565|NCT03100344|144642383|SUPERIORITY||Mean Difference (Final Values)|15.6||||0.032|TWO_SIDED|95.0|1.8|29.5|||Cochran-Mantel-Haenszel|||Week 12||29.5|1.8|0.032
72555566|NCT03100344|144642383|SUPERIORITY||Mean Difference (Final Values)|4.0||||0.553|TWO_SIDED|95.0|-9.0|16.9|||Cochran-Mantel-Haenszel|||Week 16||16.9|-9.0|0.553
72493746|NCT02889796|144516564|SUPERIORITY||Least Squares Mean Difference|-2.0|STANDARD_ERROR_OF_MEAN|0.6|<|0.001|TWO_SIDED|95.0|-4.0|-1.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-1.0|-4.0|<0.001
72493747|NCT02889796|144516564|SUPERIORITY||Least Squares Mean Difference|-4.0|STANDARD_ERROR_OF_MEAN|0.6|<|0.001|TWO_SIDED|95.0|-5.0|-2.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-2.0|-5.0|<0.001
72493748|NCT02889796|144516564|SUPERIORITY||Least Squares Mean Difference|-3.0|STANDARD_ERROR_OF_MEAN|0.6|<|0.001|TWO_SIDED|95.0|-4.0|-1.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-1.0|-4.0|<0.001
72493749|NCT02889796|144516564|SUPERIORITY||Least Squares Mean Difference|-3.0|STANDARD_ERROR_OF_MEAN|0.5|<|0.001|TWO_SIDED|95.0|-4.0|-2.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-2.0|-4.0|<0.001
72493750|NCT02889796|144516564|SUPERIORITY||Least Squares Mean Difference|-2.0|STANDARD_ERROR_OF_MEAN|0.5|<|0.001|TWO_SIDED|95.0|-3.0|-1.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-1.0|-3.0|<0.001
72493751|NCT02889796|144516566|SUPERIORITY||Least Squares Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.4||0.002|TWO_SIDED|95.0|-2.0|0.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.0|-2.0|0.002
72493752|NCT02889796|144516566|SUPERIORITY||Least Squares Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.4||0.047|TWO_SIDED|95.0|-2.0|0.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.0|-2.0|0.047
72493753|NCT02889796|144516566|SUPERIORITY||Least Squares Mean Difference|-2.0|STANDARD_ERROR_OF_MEAN|0.4|<|0.001|TWO_SIDED|95.0|-3.0|-1.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-1.0|-3.0|<0.001
72493754|NCT02889796|144516566|SUPERIORITY||Least Squares Mean Difference|-2.0|STANDARD_ERROR_OF_MEAN|0.4|<|0.001|TWO_SIDED|95.0|-3.0|-1.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-1.0|-3.0|<0.001
72493755|NCT02889796|144516566|SUPERIORITY||Least Squares Mean Difference|-2.0|STANDARD_ERROR_OF_MEAN|0.4|<|0.001|TWO_SIDED|95.0|-3.0|-1.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-1.0|-3.0|<0.001
72493756|NCT02889796|144516566|SUPERIORITY||Least Squares Mean Difference|-2.0|STANDARD_ERROR_OF_MEAN|0.4|<|0.001|TWO_SIDED|95.0|-2.0|-1.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-1.0|-2.0|<0.001
72493757|NCT02889796|144516566|SUPERIORITY||Least Squares Mean Difference|-2.0|STANDARD_ERROR_OF_MEAN|0.3|<|0.001|TWO_SIDED|95.0|-3.0|-1.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-1.0|-3.0|<0.001
72493758|NCT02889796|144516566|SUPERIORITY||Least Squares Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.3|<|0.001|TWO_SIDED|95.0|-2.0|-1.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-1.0|-2.0|<0.001
72493759|NCT02889796|144516568|SUPERIORITY||Least Squares Mean Difference|-9.0|STANDARD_ERROR_OF_MEAN|1.1|<|0.001|TWO_SIDED|95.0|-11.0|-7.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-7.0|-11.0|<0.001
72493760|NCT02889796|144516568|SUPERIORITY||Least Squares Mean Difference|-5.0|STANDARD_ERROR_OF_MEAN|1.1|<|0.001|TWO_SIDED|95.0|-7.0|-2.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-2.0|-7.0|<0.001
72493761|NCT02889796|144516568|SUPERIORITY||Least Squares Mean Difference|-9.0|STANDARD_ERROR_OF_MEAN|1.3|<|0.001|TWO_SIDED|95.0|-12.0|-7.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-7.0|-12.0|<0.001
72493762|NCT02889796|144516568|SUPERIORITY||Least Squares Mean Difference|-5.0|STANDARD_ERROR_OF_MEAN|1.3|<|0.001|TWO_SIDED|95.0|-7.0|-2.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-2.0|-7.0|<0.001
72493763|NCT02889796|144516568|SUPERIORITY||Least Squares Mean Difference|-13.0|STANDARD_ERROR_OF_MEAN|1.5|<|0.001|TWO_SIDED|95.0|-16.0|-10.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-10.0|-16.0|<0.001
72493764|NCT02889796|144516568|SUPERIORITY||Least Squares Mean Difference|-10.0|STANDARD_ERROR_OF_MEAN|1.5|<|0.001|TWO_SIDED|95.0|-12.0|-7.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-7.0|-12.0|<0.001
72493765|NCT02889796|144516568|SUPERIORITY||Least Squares Mean Difference|-11.0|STANDARD_ERROR_OF_MEAN|1.6|<|0.001|TWO_SIDED|95.0|-14.0|-7.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-7.0|-14.0|<0.001
72504469|NCT00984659|144539580|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.24|||<|0.001||95.0|0.18|0.31||ANCOVA adjusted for age, gender, and SOBDA Baseline score; difference between responders and non-responders during Week prior to Day 8|ANCOVA|||||0.31|0.18|<0.001
72374218|NCT00913458|144258769|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.63||||0.0306|TWO_SIDED|95.0|-16.4|-0.8|||Longitudinal statistical model|Values are based on a longitudinal statistical model with factors for Week 52 value, treatment, visit, and interaction of treatment.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.||-0.8|-16.4|0.0306
72374219|NCT00913458|144258770|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.51||||0.4717|TWO_SIDED|95.0|0.5|4.6|||Longitudinal statistical model|Values are based on a longitudinal statistical model with factors for treatment, visit, and interaction of treatment and visit.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.||4.6|0.5|0.4717
72374220|NCT00913458|144258770|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.77||||0.0551|TWO_SIDED|95.0|1.0|7.8|||Longitudinal statistical model|Values are based on a longitudinal statistical model with factors for treatment, visit, and interaction of treatment and visit.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.||7.8|1.0|0.0551
72374221|NCT00913458|144258770|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.84||||0.2141|TWO_SIDED|95.0|0.7|4.8|||Longitudinal statistical model|Values are based on a longitudinal statistical model with factors for treatment, visit, and interaction of treatment and visit.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.||4.8|0.7|0.2141
72374222|NCT00913458|144258772|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01||||0.9652|TWO_SIDED|95.0|-0.5|0.4|||ANCOVA|P-values for between-treatment comparisons are based on ANCOVA on ranks of change in score with ranks of Week 52 value as covariate.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.||0.4|-0.5|0.9652
72374223|NCT00913458|144258772|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.49||||0.2168|TWO_SIDED|95.0|-1.0|0.0|||ANCOVA|P-values for between-treatment comparisons are based on ANCOVA on ranks of change in score with ranks of Week 52 value as covariate.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.||0.0|-1.0|0.2168
72374224|NCT00913458|144258772|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.48||||0.2131|TWO_SIDED|95.0|-1.0|0.0|||ANCOVA|P-values for between-treatment comparisons are based on ANCOVA on ranks of change in score with ranks of Week 52 value as covariate.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.||0.0|-1.0|0.2131
72374225|NCT00913458|144258774|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.44||||0.9338|TWO_SIDED|95.0|-10.0|10.9|||ANCOVA||Values are based on a model with factors for Week 52 value, treatment, visit, and interaction of treatment and Week 52 value and treatment and visit.|Change from Week 52 to Week 91. The hyothesis of primary interest was the superiority of E25+MTX compared with PBO.||10.9|-10.0|0.9338
72374226|NCT00913458|144258774|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.55||||0.713|TWO_SIDED|95.0|-16.4|11.2|||ANCOVA|Values are based on a model with factors for Week 52 value, treatment, visit, and interaction of treatment and Week 52 value and treatment and visit.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.||11.2|-16.4|0.7130
72374227|NCT00913458|144258774|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.99||||0.6628|TWO_SIDED|95.0|-16.6|10.6|||ANCOVA|Values are based on a model with factors for Week 52 value, treatment, visit, and interaction of treatment and Week 52 value and treatment and visit.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.||10.6|-16.6|0.6628
72374228|NCT00913458|144258776|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.74||||0.1303|TWO_SIDED|95.0|-15.5|2.0|||Longitudinal statistical model|Values are based on a model with factors for Week 52 value, treatment, visit, and interaction of treatment and Week 52 value and treatment and visit.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.||2.0|-15.5|0.1303
72374229|NCT00913458|144258776|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.59||||0.0024|TWO_SIDED|95.0|-27.1|-6.0|||Longitudinal statisitical model|Values are based on a model with factors for Week 52 value, treatment, visit, and interaction of treatment and Week 52 value and treatment and visit.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.||-6.0|-27.1|0.0024
72374230|NCT00913458|144258776|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.85||||0.0621|TWO_SIDED|95.0|-20.2|0.5|||Longitudinal statistical model|||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.||0.5|-20.2|0.0621
72374231|NCT00913458|144258778|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.01||||0.4664|TWO_SIDED|95.0|-15.0|6.9|||Longitudinal statistical model|Values are based on a model with factors for Week 52 value, treatment, visit, and interaction of treatment and Week 52 value and treatment and visit.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.||6.9|-15.0|0.4664
72374232|NCT00913458|144258778|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.57||||0.021|TWO_SIDED|95.0|-30.6|-2.6|||Longitudinal statistical model|Values are based on a model with factors for Week 52 value, treatment, visit, and interaction of treatment and Week 52 value and treatment and visit.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.||-2.6|-30.6|0.0210
72374233|NCT00913458|144258778|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.56||||0.0713|TWO_SIDED|95.0|-26.2|1.1|||Longitudinal statistical model|Values are based on a model with factors for Week 52 value, treatment, visit, and interaction of treatment and Week 52 value and treatment and visit.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.||1.1|-26.2|0.0713
72374234|NCT00913458|144258780|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.11||||0.0256|TWO_SIDED|95.0|-17.1|-1.1|||Longitudinal statistical model|Values are based on a model with factors for Week 52 value, treatment, visit, and interaction of treatment and Week 52 value and treatment and visit.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.||-1.1|-17.1|0.0256
72374235|NCT00913458|144258780|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.62|||<|0.0001|TWO_SIDED|95.0|-28.1|-11.1|||Longitudinal statistical model|Values are based on a model with factors for Week 52 value, treatment, visit, and interaction of treatment and Week 52 value and treatment and visit.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.||-11.1|-28.1|<0.0001
72493766|NCT02889796|144516568|SUPERIORITY||Least Squares Mean Difference|-8.0|STANDARD_ERROR_OF_MEAN|1.6|<|0.001|TWO_SIDED|95.0|-11.0|-5.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-5.0|-11.0|<0.001
72493767|NCT02889796|144516570|SUPERIORITY||Least Squares Mean Difference|-8.0|STANDARD_ERROR_OF_MEAN|1.1|<|0.001|TWO_SIDED|95.0|-10.0|-6.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-6.0|-10.0|<0.001
72493768|NCT02889796|144516570|SUPERIORITY||Least Squares Mean Difference|-6.0|STANDARD_ERROR_OF_MEAN|1.1|<|0.001|TWO_SIDED|95.0|-8.0|-4.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-4.0|-8.0|<0.001
72493769|NCT02889796|144516570|SUPERIORITY||Least Squares Mean Difference|-8.0|STANDARD_ERROR_OF_MEAN|1.2|<|0.001|TWO_SIDED|95.0|-11.0|-6.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-6.0|-11.0|<0.001
72493770|NCT02889796|144516570|SUPERIORITY||Least Squares Mean Difference|-7.0|STANDARD_ERROR_OF_MEAN|1.2|<|0.001|TWO_SIDED|95.0|-9.0|-5.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-5.0|-9.0|<0.001
72493771|NCT02889796|144516570|SUPERIORITY||Least Squares Mean Difference|-8.0|STANDARD_ERROR_OF_MEAN|1.2|<|0.001|TWO_SIDED|95.0|-10.0|-6.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-6.0|-10.0|<0.001
72493772|NCT02889796|144516570|SUPERIORITY||Least Squares Mean Difference|-7.0|STANDARD_ERROR_OF_MEAN|1.2|<|0.001|TWO_SIDED|95.0|-10.0|-5.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-5.0|-10.0|<0.001
72493773|NCT02889796|144516570|SUPERIORITY||Least Squares Mean Difference|-8.0|STANDARD_ERROR_OF_MEAN|1.1|<|0.001|TWO_SIDED|95.0|-11.0|-6.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-6.0|-11.0|<0.001
72493774|NCT02889796|144516570|SUPERIORITY||Least Squares Mean Difference|-7.0|STANDARD_ERROR_OF_MEAN|1.1|<|0.001|TWO_SIDED|95.0|-10.0|-5.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-5.0|-10.0|<0.001
72374236|NCT00913458|144258780|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.51||||0.0161|TWO_SIDED|95.0|-19.0|-2.0|||Longitudinal statistical model|Values are based on a model with factors for Week 52 value, treatment, visit, and interaction of treatment and Week 52 value and treatment and visit.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.||-2.0|-19.0|0.0161
72493775|NCT02889796|144516572|SUPERIORITY||Least Squares Mean Difference|-9.0|STANDARD_ERROR_OF_MEAN|1.2|<|0.001|TWO_SIDED|95.0|-12.0|-7.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-7.0|-12.0|<0.001
72493776|NCT02889796|144516572|SUPERIORITY||Least Squares Mean Difference|-6.0|STANDARD_ERROR_OF_MEAN|1.2|<|0.001|TWO_SIDED|95.0|-8.0|-3.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-3.0|-8.0|<0.001
72493777|NCT02889796|144516572|SUPERIORITY||Least Squares Mean Difference|-9.0|STANDARD_ERROR_OF_MEAN|1.3|<|0.001|TWO_SIDED|95.0|-12.0|-7.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-7.0|-12.0|<0.001
72504470|NCT00984659|144539580|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.12|||<|0.001||95.0|0.06|0.19||ANCOVA adjusted for age, gender, and SOBDA Baseline score; difference between responders and non-responders during Week prior to Day 15|ANCOVA|||||0.19|0.06|<0.001
72504471|NCT00984659|144539580|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.11|||<|0.001||95.0|0.06|0.16||ANCOVA adjusted for age, gender, and SOBDA Baseline score; difference between responders and non-responders during Week prior to Day 22|ANCOVA|||||0.16|0.06|<0.001
72433246|NCT04927975|144379443|SUPERIORITY|Repeated measures analysis was conducted using a mixed model including observed measurements at all visits. The model included categorical fixed effects of treatment, visit and treatment-by-visit interaction, and stratification factors (age \[≤ 50 and \> 50\], Baseline disease severity \[T-VASI \< 15 and ≥ 15\], active vitiligo \[Yes/No\]) derived from actual values, and the continuous fixed covariate of Baseline measurement. An unstructured variance covariance matrix was used.|LS Mean Difference|-7.45||||0.12|TWO_SIDED|95.0|-16.86|1.96|||Mixed-Effect Model Repeat Measurement|||Upa 6 mg Period 1 versus Placebo Period 1||1.96|-16.86|0.120
72433247|NCT04927975|144379443|SUPERIORITY|Repeated measures analysis was conducted using a mixed model including observed measurements at all visits. The model included categorical fixed effects of treatment, visit and treatment-by-visit interaction, and stratification factors (age \[≤ 50 and \> 50\], Baseline disease severity \[T-VASI \< 15 and ≥ 15\], active vitiligo \[Yes/No\]) derived from actual values, and the continuous fixed covariate of Baseline measurement. An unstructured variance covariance matrix was used.|LS Mean Difference|-10.84||||0.026|TWO_SIDED|95.0|-20.37|-1.32|||Mixed-Effect Model Repeat Measurement|||Upa 11 mg Period 1 versus Placebo Period 1||-1.32|-20.37|0.026
72433248|NCT04927975|144379443|SUPERIORITY|Repeated measures analysis was conducted using a mixed model including observed measurements at all visits. The model included categorical fixed effects of treatment, visit and treatment-by-visit interaction, and stratification factors (age \[≤ 50 and \> 50\], Baseline disease severity \[T-VASI \< 15 and ≥ 15\], active vitiligo \[Yes/No\]) derived from actual values, and the continuous fixed covariate of Baseline measurement. An unstructured variance covariance matrix was used.|LS Mean Difference|-14.27||||0.005|TWO_SIDED|95.0|-24.24|-4.3|||Mixed-Effect Model Repeat Measurement|||Upa 22 mg Period 1 versus Placebo Period 1||-4.30|-24.24|0.005
72433249|NCT04927975|144379444|SUPERIORITY|Repeated measures analysis was conducted using a mixed model including observed measurements at all visits. The model included categorical fixed effects of treatment, visit and treatment-by-visit interaction, and stratification factors (age \[≤ 50 and \> 50\], Baseline disease severity \[T-VASI \< 15 and ≥ 15\], active vitiligo \[Yes/No\]) derived from actual values, and the continuous fixed covariate of Baseline measurement. An unstructured variance covariance matrix was used.|LS Mean Difference|-1.9||||0.545|TWO_SIDED|95.0|-8.3|4.4|||Mixed-Effect Model Repeat Measurement|||Upa 6 mg Period 1 versus Placebo Period 1||4.4|-8.3|0.545
72433250|NCT04927975|144379444|SUPERIORITY|Repeated measures analysis was conducted using a mixed model including observed measurements at all visits. The model included categorical fixed effects of treatment, visit and treatment-by-visit interaction, and stratification factors (age \[≤ 50 and \> 50\], Baseline disease severity \[T-VASI \< 15 and ≥ 15\], active vitiligo \[Yes/No\]) derived from actual values, and the continuous fixed covariate of Baseline measurement. An unstructured variance covariance matrix was used.|LS Mean Difference|1.9||||0.565|TWO_SIDED|95.0|-4.5|8.3|||Mixed-Effect Model Repeat Measurement|||Upa 11 mg Period 1 versus Placebo Period 1||8.3|-4.5|0.565
72433251|NCT04927975|144379444|SUPERIORITY|Repeated measures analysis was conducted using a mixed model including observed measurements at all visits. The model included categorical fixed effects of treatment, visit and treatment-by-visit interaction, and stratification factors (age \[≤ 50 and \> 50\], Baseline disease severity \[T-VASI \< 15 and ≥ 15\], active vitiligo \[Yes/No\]) derived from actual values, and the continuous fixed covariate of Baseline measurement. An unstructured variance covariance matrix was used.|LS Mean Difference|-1.1||||0.754|TWO_SIDED|95.0|-7.8|5.6|||Mixed-Effect Model Repeat Measurement|||Upa 22 mg Period 1 versus Placebo Period 1||5.6|-7.8|0.754
72433252|NCT03568162|144379446|SUPERIORITY|The analysis was conducted using a mixed model for repeated measures (MMRM) model for percent change from baseline in EASI with the corresponding baseline value as covariate, and treatment group, region, disease severity, visit as fixed effect factors, and interactions of treatment-by-visit, baseline-by-visit|LS Mean Difference|-20.192|STANDARD_ERROR_OF_MEAN|7.4781|=|0.008|TWO_SIDED|95.0|-34.944|5.439|||Mixed Models Analysis||A linear contrast was used to estimate the treatment difference|||5.439|-34.944|= 0.008
72433253|NCT03568162|144379446|SUPERIORITY|The analysis was conducted using a MMRM model for percent change from baseline in EASI with the corresponding baseline value as covariate, and treatment group, region, disease severity, visit as fixed effect factors, and interactions of treatment-by-visit, baseline-by-visit.|LS Mean Difference|-14.439|STANDARD_ERROR_OF_MEAN|7.6622|=|0.061|TWO_SIDED|95.0|-29.552|0.674|||Mixed Models Analysis||A linear contrast was used to estimate the treatment difference|||0.674|-29.552|= 0.061
72433254|NCT03568162|144379446|SUPERIORITY|The analysis was conducted using a mixed MMRM model for percent change from baseline in EASI with the corresponding baseline value as covariate, and treatment group, region, disease severity, visit as fixed effect factors, and interactions of treatment-by-visit, baseline-by-visit.|LS Mean Difference|3.144|STANDARD_ERROR_OF_MEAN|7.8864|=|0.691|TWO_SIDED|95.0|-12.41|18.698|||Mixed Models Analysis||A linear contrast was used to estimate the treatment difference.|||18.698|-12.410|= 0.691
72433255|NCT03568162|144379446|SUPERIORITY||LS Mean Difference|-17.199|STANDARD_ERROR_OF_MEAN|6.409|=|0.008|TWO_SIDED|95.0|-29.895|-4.503|||Mixed Models Analysis||A linear contrast was used to estimate the treatment difference.|The analysis was conducted using a MMRM model for percent change from baseline in EASI with the corresponding baseline value as covariate, and treatment group, region, disease severity, visit as fixed effect factors, and interactions of treatment-by-visit, baseline-by-visit.||-4.503|-29.895|= 0.008
72433256|NCT02081391|144379484|SUPERIORITY||Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.02||0.0404|TWO_SIDED|95.0|-0.09|0.0|||ANOVA|||The endpoint was analyzed using an analysis of variance model. This included treatment, baseline age group, and the used SOAM as factors. For participants discontinuing treatment before 12 hours for any other reason than no further need of opioid analgesics or switch to exclusively oral opioid analgesics, cumulative SOAM use over the respective time period was based on the observed SOAM use up to the time of the participant's discontinuation.||0|-0.09|0.0404
72433257|NCT02081391|144379485|SUPERIORITY||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.04||0.0154|TWO_SIDED|95.0|-0.18|-0.02|||ANOVA|||The endpoint was analyzed using an analysis of variance model. This included treatment, baseline age group, and the used supplemental opioid analgesic medication (SOAM) as factors. For participants discontinuing treatment before 24 hours for any other reason than no further need of SOAM or switch to exclusively oral opioid analgesics, cumulative SOAM use over the respective time period was based on the observed SOAM use up to the time of the participant's discontinuation.||-0.02|-0.18|0.0154
72374237|NCT03595618|144258781|SUPERIORITY||Adjusted mean difference|0.04514|STANDARD_ERROR_OF_MEAN|0.02465||0.165|TWO_SIDED|95.0|-0.00317|0.09345||Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05).|Mixed Models Analysis||Two-sided 95% confidence interval of the estimate without Dunnett adjustment.|Estimate (Standard Error) of adjusted difference from baseline to last post baseline value between treatment groups means: GLPG1972 dose minus placebo using mixed-effects model for repeated measures (MMRM) including fixed, categorical effects of treatment, region (Asia and Rest of the World), time and treatment-by-time interaction, as well as continuous, fixed covariates of baseline and time-by-baseline interaction preceded by multiple imputation step for participants without post baseline value||0.09345|-0.00317|0.165
72374238|NCT03595618|144258781|SUPERIORITY||Adjusted mean difference|0.012|STANDARD_ERROR_OF_MEAN|0.02585||0.939|TWO_SIDED|95.0|-0.03868|0.06267||Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05).|Mixed Models Analysis||Two-sided 95% confidence interval of the estimate without Dunnett adjustment.|Estimate (Standard Error) of adjusted difference from baseline to last post baseline value between treatment groups means: GLPG1972 dose minus placebo using MMRM including fixed, categorical effects of treatment, region (Asia and Rest of the World), time and treatment-by-time interaction, as well as continuous, fixed covariates of baseline and time-by-baseline interaction preceded by multiple imputation step for participants without post baseline value.||0.06267|-0.03868|0.939
72433258|NCT01779375|144379500|SUPERIORITY||||||>|0.05||||||All analyses were conducted with values on a log scale and re-exponentiated for presentation.|Regression, Linear|Measures of ß-cell response were modeled simultaneously with insulin sensitivity (M/I) using 2-df seemingly unrelated regression models.||Seemingly unrelated regression was used to compare treatment arms on the combination of insulin sensitivity (M/I as calculated from the hyperglycemic clamp) and insulin secretion (steady-state C-peptide and ACPRmax as co-primary; ACPRg as major secondary,). See statistical analysis plan for further details and R code.||||>0.05
72433259|NCT01779375|144379501|SUPERIORITY||||||>|0.05|||||||Regression, Linear|||Analyses were completed on a log scale and re-exponentiated for presentation.||||>0.05
72374239|NCT03595618|144258781|SUPERIORITY||Adjusted mean difference|0.02329|STANDARD_ERROR_OF_MEAN|0.02536||0.682|TWO_SIDED|95.0|-0.02641|0.073|||Mixed Models Analysis||Two-sided 95% confidence interval of the estimate without Dunnett adjustment.|Estimate (Standard Error) of adjusted difference from baseline to last post baseline value between treatment groups means: GLPG1972 dose minus placebo using MMRM including fixed, categorical effects of treatment, region (Asia and Rest of the World), time and treatment-by-time interaction, as well as continuous, fixed covariates of baseline and time-by-baseline interaction preceded by multiple imputation step for participants without post baseline value.||0.07300|-0.02641|0.682
72374240|NCT03595618|144258782|SUPERIORITY||Odds Ratio (OR)|1.47|STANDARD_ERROR_OF_MEAN|0.29||0.396|TWO_SIDED|95.0|0.84|2.58||Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05)|Logistic Model||Two-sided 95% Confidence Interval of the estimate without Dunnett adjustment|Estimate (Standard Error of log \[estimate\]) of the adjusted odds ratio between GLPG1972 dose regimen and placebo: between the proportions of participants with response: placebo versus GLPG1972 dose regimen||2.58|0.84|0.396
72374241|NCT03595618|144258782|SUPERIORITY||Odds Ratio (OR)|0.89|STANDARD_ERROR_OF_MEAN|0.26||0.951|TWO_SIDED|95.0|0.53|1.5||Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05)|Logistic Model||Two-sided 95% Confidence Interval of the estimate without Dunnett adjustment|Estimate (Standard Error of log \[estimate\]) of the adjusted odds ratio between GLPG1972 dose regimen and placebo: between the proportions of participants with response: placebo versus GLPG1972 dose regimen||1.50|0.53|0.951
72374242|NCT03595618|144258782|SUPERIORITY||Odds Ratio (OR)|1.08|STANDARD_ERROR_OF_MEAN|0.27||0.985|TWO_SIDED|95.0|0.64|1.83||Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05)|Logistic Model||Two-sided 95% Confidence Interval of the estimate without Dunnett adjustment|Estimate (Standard Error of log \[estimate\]) of the adjusted odds ratio between GLPG1972 dose regimen and placebo: between the proportions of participants with response: placebo versus GLPG1972 dose regimen||1.83|0.64|0.985
72374243|NCT03595618|144258783|SUPERIORITY||Adjusted mean difference|-2.1|STANDARD_ERROR_OF_MEAN|1.7||0.467|TWO_SIDED|95.0|-5.6|1.3||Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05).|Mixed Models Analysis||Two-sided 95% Confidence Interval of the estimate without Dunnett adjustment|Total score: Estimate (Standard Error) of adjusted difference from baseline to last post baseline value between treatment groups means: placebo minus GLPG1972 dose using MMRM including fixed, categorical effects of treatment, region (Asia and Rest of the World), time and treatment-by-time interaction, as well as continuous, fixed covariates of baseline and time-by-baseline interaction preceded by multiple imputation step for participants without post baseline value.||1.3|-5.6|0.467
72374244|NCT03595618|144258783|SUPERIORITY||Adjusted mean difference|-1.9|STANDARD_ERROR_OF_MEAN|1.8||0.557|TWO_SIDED|95.0|-5.4|1.5||Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05)|Mixed Models Analysis||Two-sided 95% Confidence Interval of the estimate without Dunnett adjustment.|Total score: Estimate (Standard Error) of adjusted difference from baseline to last post baseline value between treatment groups means: placebo minus GLPG1972 dose using MMRM including fixed, categorical effects of treatment, region (Asia and Rest of the World), time and treatment-by-time interaction, as well as continuous, fixed covariates of baseline and time-by-baseline interaction preceded by multiple imputation step for participants without post baseline value.||1.5|-5.4|0.557
72374245|NCT03595618|144258783|SUPERIORITY||Adjusted mean difference|-1.9|STANDARD_ERROR_OF_MEAN|1.8||0.593|TWO_SIDED|95.0|-5.3|1.6||Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05).|Mixed Models Analysis||Two-sided 95% Confidence Interval of the estimate without Dunnett adjustment.|Total score: Estimate (Standard Error) of adjusted difference from baseline to last post baseline value between treatment groups means: placebo minus GLPG1972 dose using MMRM including fixed, categorical effects of treatment, region (Asia and Rest of the World), time and treatment-by-time interaction, as well as continuous, fixed covariates of baseline and time-by-baseline interaction preceded by multiple imputation step for participants without post baseline value.||1.6|-5.3|0.593
72433260|NCT01779375|144379503|SUPERIORITY||||||>|0.05|||||||Regression, Linear|||Analyses were completed on a log scale and re-exponentiated for display.||||>0.05
72433261|NCT01743729|144379541|SUPERIORITY_OR_OTHER_LEGACY||Treatment Effect|0.03||||0.6186|TWO_SIDED|95.0|-0.1|0.17|||ANCOVA|||||0.17|-0.10|0.6186
72493778|NCT02889796|144516572|SUPERIORITY||Least Squares Mean Difference|-6.0|STANDARD_ERROR_OF_MEAN|1.3|<|0.001|TWO_SIDED|95.0|-9.0|-4.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-4.0|-9.0|<0.001
72493779|NCT02889796|144516572|SUPERIORITY||Least Squares Mean Difference|-12.0|STANDARD_ERROR_OF_MEAN|1.5|<|0.001|TWO_SIDED|95.0|-15.0|-9.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-9.0|-15.0|<0.001
72433262|NCT01743729|144379542|SUPERIORITY_OR_OTHER_LEGACY||Treatment Effect|12.61|||<|0.0001|TWO_SIDED|95.0|8.51|16.7|||ANCOVA|||||16.70|8.51|<0.0001
72433263|NCT01474538|144379557|NON_INFERIORITY_OR_EQUIVALENCE|If the upper limit of the 95% confidence interval (CI) was below 0.4%, lispro was declared non-inferior to aspart.|LS Mean difference|0.1|||||TWO_SIDED|95.0|-0.002|0.21|||Mixed Models Analysis|||||0.210|-0.002|
72433264|NCT01474538|144379558|SUPERIORITY_OR_OTHER||LS Mean difference|-0.28|||||TWO_SIDED|95.0|-2.92|2.35|||Mixed Models Analysis|||||2.35|-2.92|
72433265|NCT01474538|144379559|SUPERIORITY_OR_OTHER||LS Mean Ratio|0.94||||0.522|||||||Negative binomial|||||||0.522
72433266|NCT01474538|144379560|SUPERIORITY_OR_OTHER||LS Mean difference|-0.58||||0.216|||||||Grizzle Model|||||||0.216
72433267|NCT01474538|144379561|SUPERIORITY_OR_OTHER|||||||0.471|||||||Prescott test|||||||0.471
72433268|NCT05349864|144379590|EQUIVALENCE|Using data from Treatment A and Treatment B, natural log transformed AUClast was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Estimates of the adjusted mean differences (Test-Reference) and corresponding 90% confidence intervals (CIs) were obtained from the model, and were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CI for the ratios.|ratio of adjusted geometric means|120.25|||||TWO_SIDED|90.0|109.76|131.75||||||||131.75|109.76|
72433269|NCT05349864|144379591|EQUIVALENCE|Using data from Treatment A and Treatment B, natural log transformed AUCinf was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Estimates of the adjusted mean differences (Test-Reference) and corresponding 90% CIs were obtained from the model, and were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CI for the ratios.|ratio of adjusted geometric means|116.22|||||TWO_SIDED|90.0|97.91|137.95||||||||137.95|97.91|
72433270|NCT05349864|144379592|EQUIVALENCE|Using data from Treatment A and Treatment B, natural log transformed Cmax was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Estimates of the adjusted mean differences (Test-Reference) and corresponding 90% CIs were obtained from the model, and were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CI for the ratios.|ratio of adjusted geometric means|206.91|||||TWO_SIDED|90.0|171.14|250.15||||||||250.15|171.14|
72433271|NCT05349864|144379593|EQUIVALENCE|Using data from Treatment A and Treatment C, natural log transformed AUClast was analyzed using a mixed effect model with treatment and sequence as a fixed effect and participant within sequence as a random effect. Estimates of the adjusted mean differences (Test-Reference) and corresponding 90% CIs were obtained from the model, and were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CI for the ratios.|ratio of adjusted geometric means|135.77|||||TWO_SIDED|90.0|114.36|161.19||||||||161.19|114.36|
72433272|NCT05349864|144379594|EQUIVALENCE|Using data from Treatment A and Treatment C, natural log transformed AUCinf was analyzed using a mixed effect model with treatment and sequence as a fixed effect and participant within sequence as a random effect. Estimates of the adjusted mean differences (Test-Reference) and corresponding 90% CIs were obtained from the model, and were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CI for the ratios.|ratio of adjusted geometric means|138.36|||||TWO_SIDED|90.0|106.11|180.41||||||||180.41|106.11|
72433273|NCT05349864|144379595|EQUIVALENCE|Using data from Treatment A and Treatment C, natural log transformed Cmax was analyzed using a mixed effect model with treatment and sequence as a fixed effect and participant within sequence as a random effect. Estimates of the adjusted mean differences (Test-Reference) and corresponding 90% CIs were obtained from the model, and were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CI for the ratios.|ratio of adjusted geometric means|236.58|||||TWO_SIDED|90.0|190.12|294.38||||||||294.38|190.12|
72433274|NCT01704846|144379611|NON_INFERIORITY_OR_EQUIVALENCE|Assessment of bioequivalence between two different formulations of faldaprevir soft gelatine capsules in healthy male volunteers. The acceptance range for the geometric mean ratio was 80 to 125%.|Adjusted Geometric Mean Ratio (%)|100.47|||||TWO_SIDED|90.0|95.9|105.25|||||Ratio calculated as Test product divided by reference product|||105.25|95.90|
72433275|NCT01704846|144379612|NON_INFERIORITY_OR_EQUIVALENCE|Assessment of bioequivalence between two different formulations of faldaprevir soft gelatine capsules in healthy male volunteers. The acceptance range for the geometric mean ratio was 80 to 125%.|Adjusted Geometric Mean Ratio (%)|102.99|||||TWO_SIDED|90.0|95.57|110.98|||||Ratio calculated as Test product divided by reference product|||110.98|95.57|
72433276|NCT01704846|144379613|NON_INFERIORITY_OR_EQUIVALENCE|Assessment of bioequivalence between two different formulations of faldaprevir soft gelatine capsules in healthy male volunteers. The acceptance range for the geometric mean ratio was 80 to 125%.|Adjusted Geometric Mean Ratio (%)|100.54|||||TWO_SIDED|90.0|96.1|105.18|||||Ratio calculated as Test product divided by reference product|||105.18|96.10|
72433277|NCT01704846|144379614|NON_INFERIORITY_OR_EQUIVALENCE|Assessment of bioequivalence between two different formulations of faldaprevir soft gelatine capsules in healthy male volunteers. The acceptance range for the adjusted mean ratio was 80 to 125%.|Adjusted Mean Ratio (%)|97.66|||||TWO_SIDED|90.0|91.54|103.78|||||Ratio calculated as Test product divided by reference product|||103.78|91.54|
72433278|NCT01704846|144379615|NON_INFERIORITY_OR_EQUIVALENCE|Assessment of bioequivalence between two different formulations of faldaprevir soft gelatine capsules in healthy male volunteers. The acceptance range for the geometric mean ratio was 80 to 125%.|Adjusted Geometric Mean Ratio (%)|100.34|||||TWO_SIDED|90.0|98.51|102.2|||||Ratio calculated as Test product divided by reference product|||102.20|98.51|
72374246|NCT03595618|144258783|SUPERIORITY||Adjusted mean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.4||0.776|TWO_SIDED|95.0|-1.0|0.4||Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05).|Mixed Models Analysis||Two-sided 95% Confidence Interval of the estimate without Dunnett adjustment.|Pain subscore: Estimate (Standard Error) of adjusted difference from baseline to last post baseline value between treatment groups means: placebo minus GLPG1972 dose using MMRM including fixed, categorical effects of treatment, region (Asia and Rest of the World), time and treatment-by-time interaction, as well as continuous, fixed covariates of baseline and time-by-baseline interaction preceded by multiple imputation step for participants without post baseline value.||0.4|-1.0|0.776
72433279|NCT01704846|144379616|NON_INFERIORITY_OR_EQUIVALENCE|Assessment of bioequivalence between two different formulations of faldaprevir soft gelatine capsules in healthy male volunteers. The acceptance range for the geometric mean ratio was 80 to 125%.|Adjusted Geometric Mean Ratio (%)|99.66|||||TWO_SIDED|90.0|97.85|101.51|||||Ratio calculated as Test product divided by reference product|||101.51|97.85|
72433280|NCT01704846|144379617|NON_INFERIORITY_OR_EQUIVALENCE|Assessment of bioequivalence between two different formulations of faldaprevir soft gelatine capsules in healthy male volunteers. The acceptance range for the geometric mean ratio was 80 to 125%.|Adjusted Geometric Mean Ratio (%)|100.2|||||TWO_SIDED|90.0|98.1|102.34|||||Ratio calculated as Test product divided by reference product|||102.34|98.10|
72433281|NCT01149681|144379650|SUPERIORITY|||||||0.2364|||||||Repeated measures analysis|||||||0.2364
72433282|NCT02002819|144379667|SUPERIORITY||Mean Difference (Net)|0.07||||0.55|TWO_SIDED|95.0|-0.18|0.32|||ANOVA|||||0.32|-0.18|0.55
72433283|NCT02002819|144379668|SUPERIORITY||Mean Difference (Net)|2.9||||0.14|TWO_SIDED|95.0|-1.0|6.8|||ANOVA|||||6.8|-1.0|0.14
72433284|NCT02002819|144379669|SUPERIORITY||Mean Difference (Net)|-1.0||||0.43|TWO_SIDED|95.0|-3.4|1.5|||ANOVA|||||1.5|-3.4|.43
72433285|NCT02002819|144379670|SUPERIORITY||Mean Difference (Net)|0.1||||0.63|TWO_SIDED|95.0|-0.2|0.4|||ANOVA|||||0.4|-0.2|0.63
72433286|NCT02002819|144379671|SUPERIORITY||Mean Difference (Net)|0.1||||0.9|TWO_SIDED|95.0|-1.1|1.3|||ANOVA|||||1.3|-1.1|0.90
72433287|NCT02002819|144379672|SUPERIORITY||Mean Difference (Net)|0.0||||0.8|TWO_SIDED|95.0|-0.3|0.3|||ANOVA|||||0.3|-0.3|0.80
72433288|NCT02002819|144379673|SUPERIORITY||Mean Difference (Net)|-1.0||||0.46|TWO_SIDED|95.0|-3.6|1.7|||ANOVA|||||1.7|-3.6|0.46
72433289|NCT02002819|144379674|SUPERIORITY||Mean Difference (Net)|0.1||||0.4|TWO_SIDED|95.0|-0.9|1.1|||ANOVA|||||1.1|-0.9|0.40
72433290|NCT02002819|144379675|SUPERIORITY||Mean Difference (Net)|7.4||||0.046|TWO_SIDED|95.0|0.2|14.7|||ANOVA|||||14.7|0.2|0.046
72433291|NCT02002819|144379676|SUPERIORITY||Mean Difference (Net)|-2.5||||0.3|TWO_SIDED|95.0|-7.8|2.7|||ANOVA|||||2.7|-7.8|.30
72433292|NCT02002819|144379677|SUPERIORITY||Mean Difference (Net)|3.8||||0.52|TWO_SIDED|95.0|-8.5|16.0|||Cohen f|||||16.0|-8.5|0.52
72433293|NCT02002819|144379678|SUPERIORITY||Mean Difference (Net)|0.7||||0.4|TWO_SIDED|95.0|-1.0|2.4|||ANOVA|||||2.4|-1.0|0.40
72433294|NCT02002819|144379679|SUPERIORITY||Mean Difference (Net)|-0.2||||0.63|TWO_SIDED|95.0|-1.1|0.7|||ANOVA|||||0.7|-1.1|0.63
72433295|NCT02002819|144379681|SUPERIORITY||Mean Difference (Net)|0.8||||0.15|TWO_SIDED|95.0|-0.3|1.8|||ANOVA|||||1.8|-0.3|.15
72433296|NCT03055767|144379694|SUPERIORITY|||||||0.038|||||||Wilcoxon signed-rank test|||||||0.038
72433297|NCT03055767|144379695|SUPERIORITY|||||||0.047|||||||Wilcoxon signed-rank test)|||||||0.047
72433298|NCT03055767|144379696|SUPERIORITY|||||||0.148|||||||Wilcoxon signed-rank test)|||||||0.148
72433299|NCT03055767|144379697|SUPERIORITY|||||||0.047|||||||Wilcoxon signed-rank test)|||||||0.047
72433300|NCT03055767|144379698|SUPERIORITY|||||||0.002|||||||Wilcoxon signed-rank test)|||||||0.002
72433301|NCT03055767|144379699|SUPERIORITY|||||||0.82|||||||McNemar|||||||0.82
72433302|NCT03055767|144379700|SUPERIORITY|||||||0.006|||||||McNemar|||||||0.006
72433303|NCT03055767|144379701|SUPERIORITY|||||||0.039|||||||McNemar|||||||0.039
72433304|NCT03055767|144379702|SUPERIORITY|||||||0.016|||||||McNemar|||||||0.016
72433305|NCT03055767|144379703|SUPERIORITY|||||||0.18|||||||McNemar|||||||0.18
72433306|NCT03055767|144379704|SUPERIORITY||||||<|0.001|||||||Wilcoxon signed-rank test)|||||||<0.001
72433307|NCT03055767|144379705|SUPERIORITY|||||||0.64|||||||Wilcoxon signed-rank test)|||||||0.64
72433308|NCT02661997|144379714|SUPERIORITY|||||||0.58||||||Between group differences|ANOVA|||||||0.58
72433309|NCT02661997|144379715|SUPERIORITY|||||||0.88|||||||ANOVA|||||||0.88
72433310|NCT02661997|144379716|SUPERIORITY|||||||0.17|||||||ANOVA|||||||0.17
72433311|NCT02661997|144379717|SUPERIORITY|||||||0.88|||||||ANOVA|||This is an analysis of pre to post-treatment changes on the Physical Health subscale of the PROMIS Global Health Scale||||0.88
72433312|NCT02661997|144379718|SUPERIORITY|||||||0.032||||||P-value for group by time interaction|ANOVA|||||||0.032
72433313|NCT02661997|144379719|SUPERIORITY|||||||0.006||||||P-value for group by time interaction|ANOVA|||||||0.006
72433314|NCT02661997|144379720|SUPERIORITY|||||||0.44||||||P-value for group by time interaction|ANOVA|||||||0.44
72433315|NCT02661997|144379721|SUPERIORITY|||||||0.36||||||P-value for group by time interaction|ANOVA|||||||0.36
72433316|NCT02661997|144379722|SUPERIORITY|||||||0.24|||||||ANOVA|||||||0.24
72433317|NCT02661997|144379723|SUPERIORITY|||||||0.55||||||P-value for group by time interaction|ANOVA|||||||0.55
72433318|NCT02661997|144379724|SUPERIORITY|||||||0.36||||||P-value for group by time interaction|ANOVA|||||||0.36
72433319|NCT02661997|144379725|SUPERIORITY|||||||0.73||||||P-value for group by time interaction|ANOVA|||||||0.73
72433320|NCT02427737|144379749|SUPERIORITY||||||<|0.0001||||||Bonferroni-corrected p-values were used after multiplying the uncorrected p-value by 10.|Chi-squared, Corrected|||Comparison among trained and untrained sites||||<0.0001
72433321|NCT02427737|144379749|SUPERIORITY|||||||0.3037||||||Bonferroni-corrected p-values were used after multiplying the uncorrected p-value by 10.|Chi-squared, Corrected|||Change in the average quarterly completion rate as compared to the baseline quarter||||0.3037
72433322|NCT02427737|144379749|SUPERIORITY||||||<|0.01||||||Bonferroni-corrected p-values were used after multiplying the uncorrected p-value by 10.|Chi-squared, Corrected|||Change in the average quarterly completion rate as compared to the baseline quarter||||<0.01
72433323|NCT02427737|144379750|SUPERIORITY||||||<|0.0001||||||Bonferroni-corrected p-values were used after multiplying the uncorrected p-value by 10.|Chi-squared, Corrected|||Comparison among trained and untrained sites||||<0.0001
72433324|NCT02427737|144379750|SUPERIORITY|||||||0.201||||||Bonferroni-correction was not done since the corrected p-value would be have been greater than 1.|Chi-squared|||Change in the average quarterly completion rate as compared to the baseline quarter||||0.2010
72433325|NCT02427737|144379750|SUPERIORITY||||||<|0.001||||||Bonferroni-corrected p-values were used after multiplying the uncorrected p-value by 10.|Chi-squared|||Change in the average quarterly completion rate as compared to the baseline quarter||||<0.001
72433326|NCT02427737|144379751|SUPERIORITY||||||<|0.0001||||||Bonferroni-corrected p-values were used after multiplying the uncorrected p-value by 10.|Chi-squared|||Comparison among trained and untrained sites||||<0.0001
72433327|NCT02427737|144379751|SUPERIORITY|||||||0.303||||||"Bonferroni-corrected p-values were used after multiplying the uncorrected p-value by 10.~Chi-square analysis was used to assess equipment utilization at trained sites compared with untrained sites when stratifying by time (chi-square MH = 858.2)."|Chi-squared|||Change in the quarterly equipment utilization rate as compared to the baseline quarter Q4FY15 over time and at sites||||0.303
72433328|NCT02427737|144379751|SUPERIORITY||||||<|0.001||||||Bonferroni-corrected p-values were used after multiplying the uncorrected p-value by 10.|Chi-squared, Corrected|||Change in the average quarterly completion rate as compared to the baseline quarter||||<0.001
72433329|NCT02427737|144379752|SUPERIORITY||||||<|0.0001||||||CMH test was used with time as a strata variable (rather than pooling all data together as in the regular chi-squared test). The CMH chi-squared value was 858.2, and the regular chi-squared value was 858.8.|Chi-squared, Corrected|Bonferroni-corrected p-values were used after multiplying the uncorrected p-value by 10.||||||<0.0001
72433330|NCT02427737|144379753|SUPERIORITY||||||<|0.0001|||||||Chi-squared|||||||<0.0001
72374247|NCT03595618|144258783|SUPERIORITY||Adjusted mean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.4||0.446|TWO_SIDED|95.0|-1.2|0.3||Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05).|Mixed Models Analysis||Two-sided 95% Confidence Interval of the estimate without Dunnett adjustment.|Pain subscore: Estimate (Standard Error) of adjusted difference from baseline to last post baseline value between treatment groups means: placebo minus GLPG1972 dose using MMRM including fixed, categorical effects of treatment, region (Asia and Rest of the World), time and treatment-by-time interaction, as well as continuous, fixed covariates of baseline and time-by-baseline interaction preceded by multiple imputation step for participants without post baseline value.||0.3|-1.2|0.446
72374248|NCT03595618|144258783|SUPERIORITY||Adjusted mean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.4||0.649|TWO_SIDED|95.0|-1.1|0.4||Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05).|Mixed Models Analysis||Two-sided 95% Confidence Interval of the estimate without Dunnett adjustment.|Pain subscore: Estimate (Standard Error) of adjusted difference from baseline to last post baseline value between treatment groups means: placebo minus GLPG1972 dose using MMRM including fixed, categorical effects of treatment, region (Asia and Rest of the World), time and treatment-by-time interaction, as well as continuous, fixed covariates of baseline and time-by-baseline interaction preceded by multiple imputation step for participants without post baseline value.||0.4|-1.1|0.649
72374249|NCT03595618|144258783|SUPERIORITY||Adjusted mean difference|-1.6|STANDARD_ERROR_OF_MEAN|1.3||0.452|TWO_SIDED|95.0|-4.1|0.9||Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05).|Mixed Models Analysis||Two-sided 95% Confidence Interval of the estimate without Dunnett adjustment.|Physical function subscore: Estimate (Standard Error) of adjusted difference from baseline to last post baseline value between treatment groups means: placebo minus GLPG1972 dose using MMRM including fixed, categorical effects of treatment, region (Asia and Rest of the World), time and treatment-by-time interaction, as well as continuous, fixed covariates of baseline and time-by-baseline interaction preceded by multiple imputation step for participants without post baseline value.||0.9|-4.1|0.452
72433331|NCT02427737|144379755|SUPERIORITY|||||||0.2357||||||Bonferroni-corrected p-values were used after multiplying the uncorrected p-value by 10.|Chi-squared, Corrected|||Comparison among trained and untrained sites||||0.2357
72433332|NCT02427737|144379755|SUPERIORITY|||||||0.8523||||||No Bonferroni-correction|Chi-squared|||Change in the quarterly no-shows as compared to the baseline quarter||||0.8523
72395053|NCT02700815|144296597|SUPERIORITY||Mean Difference (Net)|2.02|STANDARD_ERROR_OF_MEAN|0.95||0.0339|TWO_SIDED|95.0|0.15|3.88|||Mixed Models Analysis||The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|A Mixed Model Repeat Measures (MMRM) analysis was used to compare change in PA from baseline between diclofenac and combination therapy diclofenac + capsaicin. MMRM model included fixed effects of treatment, country, application site (back/neck), time and fixed covariates of baseline PA and baseline PA by time interaction.||3.88|0.15|0.0339
72433333|NCT02427737|144379755|SUPERIORITY|||||||0.5883||||||Bonferroni-correction was not done for this nonsignificant result since the corrected p-value would be have been greater than 1, which is not possible.|Chi-squared|||Change in the quarterly average no-show rate as compared to the baseline quarter at untrained sites||||0.5883
72433334|NCT02427737|144379756|SUPERIORITY|||||||0.0195||||||Bonferroni-corrected p-values were used after multiplying the uncorrected p-value by 10.|Chi-squared, Corrected|||Comparison among trained and untrained sites||||0.0195
72433335|NCT02427737|144379756|SUPERIORITY|||||||0.276||||||No Bonferroni-correction|Chi-squared|||Change in the quarterly no-shows compared to the baseline quarter||||0.276
72433336|NCT02427737|144379756|SUPERIORITY|||||||0.2764||||||No Bonferroni-correction|Chi-squared|||Change in the quarterly no-shows as compared to the baseline quarter at untrained sites||||0.2764
72433337|NCT02427737|144379757|SUPERIORITY||||||<|0.01||||||Bonferroni-corrected p-values were used after multiplying the uncorrected p-value by 10.|Chi-squared, Corrected|||Comparison among trained and untrained sites||||<0.01
72433338|NCT02427737|144379757|SUPERIORITY|||||||0.9012||||||Bonferroni-correction was not done since the corrected p-value would be have been greater than 1.|Chi-squared|||Change in the quarterly average no show rate as compared to the baseline quarter for trained sites||||0.9012
72433339|NCT02427737|144379757|SUPERIORITY|||||||0.9065||||||Bonferroni-corrected p-values were used after multiplying the uncorrected p-value by 10.|Chi-squared, Corrected|||Change in the quarterly average no-show rate as compared to the baseline quarter for untrained sites||||0.9065
72433340|NCT02427737|144379758|SUPERIORITY||||||<|0.0001||||||Bonferroni-corrected p-values were used after multiplying the uncorrected p-value by 10.|Chi-squared, Corrected|CMH test with time as a strata variable was 28.7; chi-square value with pooling all data together was 28.6||Comparison among trained and untrained sites over time||||<0.0001
72433341|NCT02427737|144379763|SUPERIORITY||||||<|0.0001|||||||Chi-squared|||||||<0.0001
72433342|NCT02427737|144379764|SUPERIORITY|||||||0.2396|||||||Chi-squared|||||||0.2396
72433343|NCT02427737|144379765|SUPERIORITY|||||||0.5267|||||||Chi-squared|||||||0.5267
72433344|NCT02427737|144379766|SUPERIORITY||||||<|0.0001|||||||Chi-squared|||||||<0.0001
72433345|NCT02427737|144379767|SUPERIORITY||||||<|0.0001|||||||Chi-squared|||||||<0.0001
72433346|NCT00335556|144379768|OTHER||Log Rank Test Statistic|5.419||||0.0199|TWO_SIDED|95.0|||||Log Rank|||The event-free survival distributions of patients with Stage II-IV diffuse anaplastic Wilms' tumor on AREN0321 and NWTS-5 (NCT00002610) were compared using the log-rank test.||||.0199
72433347|NCT00335556|144379769|OTHER||Log Rank Test Statistic|0.8814||||0.3478|TWO_SIDED|95.0|||||Log Rank|||The overall survival distributions of patients with Stage I-IV malignant rhabdoid tumors on AREN0321 and National Wilms Tumor Study-5 -- Treatment of Relapsed Patients, A National Wilms Tumor Study Group Phase III Study (NCT00002610) were compared using the log-rank test.||||.3478
72433348|NCT00335556|144379771|OTHER||Log Rank Test Statistic|3.6216||||0.057|TWO_SIDED|95.0|||||Log Rank|||The event-free survival distributions of patients with Stage I focal and diffuse anaplastic Wilms tumors on AREN0321 and National Wilms Tumor Study-5 -- Treatment of Relapsed Patients, A National Wilms Tumor Study Group Phase III Study (NCT00002610) were compared using the log-rank test.||||.0570
72433349|NCT02974010|144379779|SUPERIORITY|||||||0.03||||||BDM LS difference overall|Mixed Models Analysis|BDM LS difference overall||||||.03
72433350|NCT00320489|144379780|SUPERIORITY_OR_OTHER|||||||0.612||95.0|||||Log Rank|||||||0.612
72433351|NCT00320489|144379781|SUPERIORITY_OR_OTHER|||||||0.649||95.0||||P-Value is for change from baseline at Week 104.|ANCOVA|Model: Change = Therapy, Investigator, Visit, Therapy\*Visit Baseline.||||||0.649
72433352|NCT00320489|144379782|SUPERIORITY_OR_OTHER|||||||0.744||95.0||||P-value for change at Week 104 in Mental Score Detail.|ANCOVA|Change = Therapy, Investigator, Visit, Therapy\*Visit, Baseline.||||||0.744
72433353|NCT00320489|144379782|SUPERIORITY_OR_OTHER|||||||0.653||95.0||||P-value for change at Week 104 in Physical Score Detail.|ANCOVA|Change = Therapy, Investigator, Visit, Therapy\*Visit, Baseline.||||||0.653
72433354|NCT00320489|144379782|SUPERIORITY_OR_OTHER|||||||0.64||95.0||||P-value for change at Week 104 in Physical Functioning.|ANCOVA|Change = Therapy, Investigator, Visit, Therapy\*Visit, Baseline.||||||0.640
72433355|NCT00320489|144379782|SUPERIORITY_OR_OTHER|||||||0.454||95.0||||P-value for change at Week 104 in Role-Physical.|ANCOVA|Change = Therapy, Investigator, Visit, Therapy\*Visit, Baseline.||||||0.454
72433356|NCT00320489|144379782|SUPERIORITY_OR_OTHER|||||||0.135||95.0||||P-value for change at Week 104 in Bodily Pain.|ANCOVA|Change = Therapy, Investigator, Visit, Therapy\*Visit, Baseline.||||||0.135
72433357|NCT00320489|144379782|SUPERIORITY_OR_OTHER|||||||0.229||95.0||||P-value for change at Week 104 in General Health.|ANCOVA|Change = Therapy, Investigator, Visit, Therapy\*Visit, Baseline.||||||0.229
72433358|NCT00320489|144379782|SUPERIORITY_OR_OTHER|||||||0.594||95.0||||P-value for change at Week 104 in Vitality.|ANCOVA|Change = Therapy, Investigator, Visit, Therapy\*Visit, Baseline.||||||0.594
72433359|NCT00320489|144379782|SUPERIORITY_OR_OTHER|||||||0.256||95.0||||P-value for change at Week 104 in Social Functioning.|ANCOVA|Change = Therapy, Investigator, Visit, Therapy\*Visit, Baseline.||||||0.256
72433360|NCT00320489|144379782|SUPERIORITY_OR_OTHER|||||||0.775||95.0||||P-value for change at Week 104 in Role-Emotional.|ANCOVA|Change = Therapy, Investigator, Visit, Therapy\*Visit, Baseline.||||||0.775
72433361|NCT00320489|144379782|SUPERIORITY_OR_OTHER|||||||0.781||95.0||||P-value for change at Week 104 in Mental Health.|ANCOVA|Change = Therapy, Investigator, Visit, Therapy\*Visit, Baseline.||||||0.781
72433362|NCT00320489|144379783|SUPERIORITY_OR_OTHER|||||||0.465||95.0||||P-value is for change from baseline to Week 104.|ANCOVA|Change = Therapy, Investigator, Visit, Therapy\*Visit, Baseline.||||||0.465
72433363|NCT00320489|144379784|SUPERIORITY_OR_OTHER|||||||0.581||95.0||||P-value is for change from baseline to Week 104.|ANCOVA|Change = Therapy, Investigator, Visit, Therapy\*Visit, Baseline.||||||0.581
72395054|NCT00720434|144296637|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-2.36357||||0.0131|TWO_SIDED|95.0|-4.19228|-0.53485|||ANCOVA|||An analysis of covariance (ANCOVA) model was used to compare differences among treatments. Independent variables included treatment and log-transformed baseline HCV viral load. Adjusted mean difference and corresponding 95 percentage (%) confidence interval (CI) were calculated.||-0.53485|-4.19228|0.0131
72433364|NCT00320489|144379787|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||ANOVA|P-value is type III p-value of ANOVA model: Total number of hospitalization days = Therapy.||||||0.020
72433365|NCT00320489|144379788|SUPERIORITY_OR_OTHER|||||||0.583||95.0||||P-value is for Total Score (Items 1-5) change to Week 104.|ANCOVA|Model: change = investigator, treatment, and baseline.||||||0.583
72433366|NCT00320489|144379788|SUPERIORITY_OR_OTHER|||||||0.747||95.0||||P-value is for Total Score (Items 1-4) change to Week 104.|ANCOVA|Model: change = investigator, treatment, and baseline.||||||0.747
72433367|NCT00320489|144379789|SUPERIORITY_OR_OTHER|||||||0.371||95.0||||P-value is for change from baseline to Week 104.|ANCOVA|Model: change = investigator, treatment, and baseline.||||||0.371
72433368|NCT00320489|144379790|SUPERIORITY_OR_OTHER|||||||0.681||95.0||||P-value is fro change from baseline to Week 104.|ANCOVA|Model: Change = Therapy, Investigator, Visit, Therapy\*Visit, Baseline.||||||0.681
72433369|NCT00320489|144379791|SUPERIORITY_OR_OTHER|||||||0.6||95.0||||P-value is for overall satisfaction with current medication.|ANCOVA|Model: Actual Result = Therapy, Investigator, Visit, Therapy\*Visit.||||||0.60
72433370|NCT00320489|144379791|SUPERIORITY_OR_OTHER|||||||0.258||95.0||||P-value is for preference current/previous medication.|ANCOVA|Model: Actual Result = Therapy, Investigator, Visit, Therapy\*Visit||||||.258
72433371|NCT00320489|144379791|SUPERIORITY_OR_OTHER|||||||0.492||95.0||||P-value is for side effects - current vs previous medication.|ANCOVA|Model: Actual Result = Therapy, Investigator, Visit, Therapy\*Visit.||||||0.492
72433372|NCT00320489|144379792|SUPERIORITY_OR_OTHER|||||||0.854||95.0|||||ANCOVA|Model: Actual Result = Therapy, Investigator, Visit, Therapy\*Visit.||||||0.854
72433373|NCT00320489|144379793|SUPERIORITY_OR_OTHER|||||||0.6||95.0|||||Fisher Exact|||||||0.600
72433374|NCT00320489|144379794|SUPERIORITY_OR_OTHER|||||||0.282||95.0|||||ANCOVA|Model: Change = Therapy, Investigator, Visit, Therapy\*Visit Baseline.||||||0.282
72433375|NCT00320489|144379795|SUPERIORITY_OR_OTHER|||||||0.834||95.0||||P-value is for PANSS Total Score.|ANCOVA|Model: Change = Therapy, Investigator, Visit, Therapy\*Visit Baseline.||||||0.834
72433376|NCT00320489|144379795|SUPERIORITY_OR_OTHER|||||||0.871||95.0||||P-value is for PANSS Positive Score.|ANCOVA|Model: Change = Therapy, Investigator, Visit, Therapy\*Visit Baseline.||||||0.871
72555567|NCT03100344|144642383|SUPERIORITY||Mean Difference (Final Values)|20.9||||0.008|TWO_SIDED|95.0|6.1|35.8|||Cochran-Mantel-Haenszel|||Week 16||35.8|6.1|0.008
72555568|NCT03100344|144642383|SUPERIORITY||Mean Difference (Final Values)|13.9||||0.061|TWO_SIDED|95.0|-0.3|28.2|||Cochran-Mantel-Haenszel|||Week 16||28.2|-0.3|0.061
72555569|NCT03100344|144642383|SUPERIORITY||Mean Difference (Final Values)|4.0||||0.585|TWO_SIDED|95.0|-10.1|18.0|||Cochran-Mantel-Haenszel|||Week 20||18.0|-10.1|0.585
72555570|NCT03100344|144642383|SUPERIORITY||Mean Difference (Final Values)|17.4||||0.032|TWO_SIDED|95.0|2.0|32.8|||Cochran-Mantel-Haenszel|||Week 20||32.8|2.0|0.032
72555571|NCT03100344|144642383|SUPERIORITY||Mean Difference (Final Values)|8.6||||0.254|TWO_SIDED|95.0|-5.9|23.1|||Cochran-Mantel-Haenszel|||Week 20||23.1|-5.9|0.254
72555572|NCT03100344|144642383|SUPERIORITY||Mean Difference (Final Values)|4.2||||0.598|TWO_SIDED|95.0|-11.3|19.8|||Cochran-Mantel-Haenszel|||Week 24||19.8|-11.3|0.598
72555573|NCT03100344|144642383|SUPERIORITY||Mean Difference (Final Values)|15.5||||0.066|TWO_SIDED|95.0|-0.4|31.4|||Cochran-Mantel-Haenszel|||Week 24||31.4|-0.4|0.066
72555574|NCT03100344|144642383|SUPERIORITY||Mean Difference (Final Values)|1.7||||0.826|TWO_SIDED|95.0|-13.5|16.9|||Cochran-Mantel-Haenszel|||Week 24||16.9|-13.5|0.826
72555575|NCT03100344|144642384|SUPERIORITY||mean difference of percentage changes|-10.0||||0.049|TWO_SIDED|95.0|-20.0|0.0|||Kenward-Rogers|||Week 1||0.0|-20.0|0.049
72555576|NCT03100344|144642384|SUPERIORITY||mean difference of percentage changes|-16.9|||<|0.001|TWO_SIDED|95.0|-26.7|-7.0|||Kenward Roger|||Week 1||-7.0|-26.7|<0.001
72555577|NCT03100344|144642384|SUPERIORITY||mean difference of percentage changes|-15.7||||0.002|TWO_SIDED|95.0|-25.6|-5.8|||Kenward Roger|||Week 1||-5.8|-25.6|0.002
72555578|NCT03100344|144642384|SUPERIORITY||mean difference of percentage changes|-9.8||||0.084|TWO_SIDED|95.0|-20.9|1.3|||Kenward Roger|||Week 2||1.3|-20.9|0.084
72618300|NCT00286455|144767662|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.07||||0.656|TWO_SIDED|95.0|-0.378|0.239||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.239|-0.378|0.656
72433377|NCT00320489|144379795|SUPERIORITY_OR_OTHER|||||||0.692||95.0||||P-value is for PANSS Negative Score.|ANCOVA|Model: Change = Therapy, Investigator, Visit, Therapy\*Visit, Baseline.||||||0.692
72555579|NCT03100344|144642384|SUPERIORITY||mean difference of percentage changes|-16.2||||0.004|TWO_SIDED|95.0|-27.2|-5.2|||Kenward Roger|||Week 2||-5.2|-27.2|0.004
72555580|NCT03100344|144642384|SUPERIORITY||mean difference of percentage changes|-14.8||||0.008|TWO_SIDED|95.0|-25.8|-3.8|||Kenward Roger|||Week 2||-3.8|-25.8|0.008
72555581|NCT03100344|144642384|SUPERIORITY||mean difference of percentage changes|-14.0||||0.044|TWO_SIDED|95.0|-27.5|-0.4|||Kenward Roger|||Week 4||-0.4|-27.5|0.044
72555582|NCT03100344|144642384|SUPERIORITY||mean difference of percentage changes|-21.1||||0.002|TWO_SIDED|95.0|-34.7|-7.6|||Kenward Roger|||Week 4||-7.6|-34.7|0.002
72555583|NCT03100344|144642384|SUPERIORITY||mean difference of percentage changes|-15.3||||0.026|TWO_SIDED|95.0|-28.8|-1.8|||Kenward Roger|||Week 4||-1.8|-28.8|0.026
72555584|NCT03100344|144642384|SUPERIORITY||mean difference of percentage changes|-14.8||||0.062|TWO_SIDED|95.0|-30.2|0.7|||Kenward Roger|||Week 8||0.7|-30.2|0.062
72555585|NCT03100344|144642384|SUPERIORITY||mean difference of percentage changes|-23.4||||0.003|TWO_SIDED|95.0|-38.9|-7.9|||Kenward Roger|||Week 8||-7.9|-38.9|0.003
72555586|NCT03100344|144642384|SUPERIORITY||mean difference of percentage changes|-20.6||||0.009|TWO_SIDED|95.0|-36.0|-5.2|||Kenward Roger|||Week 8||-5.2|-36.0|0.009
72555587|NCT03100344|144642384|SUPERIORITY||mean difference of percentage changes|-15.9||||0.022|TWO_SIDED|95.0|-29.4|-2.3|||Kenward Roger|||Week 12||-2.3|-29.4|0.022
72555588|NCT03100344|144642384|SUPERIORITY||mean difference of percentage changes|-23.7|||<|0.001|TWO_SIDED|95.0|-37.1|-10.2|||Kenward Roger|||Week 12||-10.2|-37.1|<0.001
72555589|NCT03100344|144642384|SUPERIORITY||mean difference of percentage changes|-14.7||||0.032|TWO_SIDED|95.0|-28.1|-1.3|||Kenward Roger|||Week 12||-1.3|-28.1|0.032
72555590|NCT03100344|144642384|SUPERIORITY||mean difference of percentage changes|-13.7||||0.07|TWO_SIDED|95.0|-28.6|1.1|||Kenward Roger|||Week 16||1.1|-28.6|0.070
72555591|NCT03100344|144642384|SUPERIORITY||mean difference of percentage changes|-23.7||||0.002|TWO_SIDED|95.0|-38.5|-8.9|||Kenward Roger|||Week 16||-8.9|-38.5|0.002
72555592|NCT03100344|144642384|SUPERIORITY||mean difference of percentage changes|-10.7||||0.154|TWO_SIDED|95.0|-25.6|4.1|||Kenward Roger|||Week 16||4.1|-25.6|0.154
72555593|NCT03100344|144642384|SUPERIORITY||mean difference of percentage changes|-12.1||||0.09|TWO_SIDED|95.0|-26.0|1.9|||Kenward Roger|||Week 20||1.9|-26.0|0.090
72555594|NCT03100344|144642384|SUPERIORITY||mean difference of percentage changes|-15.9||||0.024|TWO_SIDED|95.0|-29.7|-2.1|||Kenward Roger|||Week 20||-2.1|-29.7|0.024
72555595|NCT03100344|144642384|SUPERIORITY||mean difference of percentage changes|-9.5||||0.18|TWO_SIDED|95.0|-23.4|4.4|||Kenward Roger|||Week 20||4.4|-23.4|0.180
72555596|NCT03100344|144642384|SUPERIORITY||mean difference of percentage changes|-13.6||||0.051|TWO_SIDED|95.0|-27.3|0.0|||Kenward Roger|||Week 24||0.0|-27.3|0.051
72555597|NCT03100344|144642384|SUPERIORITY||mean difference of percentage changes|-16.7||||0.016|TWO_SIDED|95.0|-30.2|-3.2|||Kenward Roger|||Week 24||-3.2|-30.2|0.016
72555598|NCT03100344|144642384|SUPERIORITY||mean difference of percentage changes|-6.8||||0.322|TWO_SIDED|95.0|-20.5|6.8|||Kenward Roger|||Week 24||6.8|-20.5|0.322
72555599|NCT03100344|144642385|SUPERIORITY||mean difference of percentage changes|-10.9||||0.012|TWO_SIDED|95.0|-19.4|-2.4|||Kenward Roger|||Week 1||-2.4|-19.4|0.012
72555600|NCT03100344|144642385|SUPERIORITY||mean difference of percentage changes|-15.4|||<|0.001|TWO_SIDED|95.0|-23.8|-7.1|||Kenward Roger|||Week 1||-7.1|-23.8|<0.001
72555601|NCT03100344|144642385|SUPERIORITY||mean difference of percentage changes|-9.4||||0.029|TWO_SIDED|95.0|-17.8|-0.9|||Kenward Roger|||Week 1||-0.9|-17.8|0.029
72555602|NCT03100344|144642385|SUPERIORITY||mean difference of percentage changes|-21.8|||<|0.001|TWO_SIDED|95.0|-32.0|-11.6|||Kenward Roger|||Week 2||-11.6|-32.0|<0.001
72555603|NCT03100344|144642385|SUPERIORITY||mean difference of percentage changes|-29.1|||<|0.001|TWO_SIDED|95.0|-39.1|-19.1|||Kenward Roger|||Week 2||-19.1|-39.1|<0.001
72433378|NCT00320489|144379795|SUPERIORITY_OR_OTHER|||||||0.893||95.0||||P-value is for PANSS General Psychopathology Score.|ANCOVA|Model: Change = Therapy, Investigator, Visit, Therapy\*Visit, Baseline.||||||0.893
72433379|NCT00320489|144379796|SUPERIORITY_OR_OTHER|||||||0.585||95.0|||||Log Rank|||||||0.585
72433380|NCT00320489|144379797|SUPERIORITY_OR_OTHER|||||||0.659||95.0|||||Fisher Exact|||||||0.659
72433381|NCT00320489|144379798|SUPERIORITY_OR_OTHER|||||||0.952||95.0|||||ANCOVA|Model: Change = Therapy, Investigator, Visit, Therapy\*Visit Baseline.||||||0.952
72433382|NCT00320489|144379800|SUPERIORITY_OR_OTHER|||||||0.777||95.0||||P-value is for change from baseline to Week 104.|ANCOVA|Model: change = baseline, treatment, and investigator.||||||0.777
72433383|NCT00320489|144379801|SUPERIORITY_OR_OTHER|||||||0.53||95.0|||||Fisher Exact|||||||0.530
72433384|NCT00320489|144379802|SUPERIORITY_OR_OTHER|||||||0.258||95.0||||P-value for fasting glucose.|Fisher Exact|||||||0.258
72433385|NCT00320489|144379802|SUPERIORITY_OR_OTHER|||||||0.688||95.0||||P-value is for fasting total cholesterol.|Fisher Exact|||||||0.688
72433386|NCT00320489|144379802|SUPERIORITY_OR_OTHER|||||||0.908||95.0||||P-value is for fasting triglycerides.|Fisher Exact|||||||0.908
72433387|NCT00320489|144379803|SUPERIORITY_OR_OTHER|||||||0.835||95.0|||||Fisher Exact|||||||0.835
72433388|NCT00320489|144379804|SUPERIORITY_OR_OTHER|||||||0.834||95.0||||P-value is for ALT.|Fisher Exact|||||||0.834
72433389|NCT00320489|144379804|SUPERIORITY_OR_OTHER|||||||0.723||95.0||||P-value is for AST.|Fisher Exact|||||||0.723
72433390|NCT00320489|144379804|SUPERIORITY_OR_OTHER|||||||0.247||95.0||||P-value is for total bilirubin.|Fisher Exact|||||||0.247
72433391|NCT00320489|144379805|SUPERIORITY_OR_OTHER|||||||0.885||95.0|||||Fisher Exact|||||||0.885
72433392|NCT00580801|144379874|SUPERIORITY_OR_OTHER||Least square mean ratio|0.98||||||90.0|0.54|1.78|||||Day 1: The least square (LS) means of the primary parameters for the test and the reference groups were estimated with a linear mixed effects model controlling for treatment group as fixed effects.|||1.78|0.54|
72504472|NCT00984659|144539580|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.11|||<|0.001||95.0|0.06|0.17||ANCOVA adjusted for age, gender, and SOBDA Baseline score; difference between responders and non-responders during Week prior to Day 29|ANCOVA|||||0.17|0.06|<0.001
72433393|NCT00580801|144379874|SUPERIORITY_OR_OTHER||Least square mean ratio|1.33||||||90.0|1.03|1.72|||||Day 15: The LS means of the primary parameters for the test and the reference groups were estimated with a linear mixed effects model controlling for treatment group as fixed effects.|||1.72|1.03|
72433394|NCT00580801|144379875|SUPERIORITY_OR_OTHER||Least square mean ratio|1.0||||||90.0|0.58|1.72|||||Day 1: The LS means of the primary parameters for the test and the reference groups were estimated with a linear mixed effects model controlling for treatment group as fixed effects.|||1.72|0.58|
72433395|NCT00580801|144379875|SUPERIORITY_OR_OTHER||Least square mean ratio|1.32||||||90.0|1.05|1.66|||||Day 15: The LS means of the primary parameters for the test and the reference groups were estimated with a linear mixed effects model controlling for treatment group as fixed effects.|||1.66|1.05|
72433396|NCT00580801|144379876|SUPERIORITY_OR_OTHER||Least square mean ratio|1.43||||||90.0|1.02|2.02|||||Day 15: The LS means of the primary parameters for the test and the reference groups were estimated with a linear mixed effects model controlling for treatment group as fixed effects.|||2.02|1.02|
72433397|NCT00580801|144379877|SUPERIORITY_OR_OTHER||Least square mean ratio|1.24||||||90.0|0.88|1.74|||||Day 15: The LS means of the primary parameters for the test and the reference groups were estimated with a linear mixed effects model controlling for treatment group as fixed effects.|||1.74|0.88|
72433398|NCT01664104|144379995|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value was calculated between baseline versus change at Month 3.|Wilcoxon test|||||||<0.0001
72433399|NCT01664104|144379995|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value was calculated between baseline versus change at Month 6.|Wilcoxon test|||||||<0.0001
72433400|NCT01664104|144379996|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-value was calculated between baseline versus change at Month 3.|Wilcoxon test|||||||<0.0001
72433401|NCT01664104|144379996|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Wilcoxon test|P-value was calculated between baseline versus change at Month 6.||||||<0.0001
72433402|NCT01664104|144379997|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Wilcoxon test|P-value was calculated between baseline versus change at Month 3.||||||<0.0001
72433403|NCT01664104|144379997|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Wilcoxon test|P-value was calculated between baseline versus change at Month 6.||||||<0.0001
72433404|NCT01664104|144380017|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value was calculated between baseline versus change at Month 3.|Wilcoxon test|||||||<0.0001
72433405|NCT01664104|144380017|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-value was calculated between baseline versus change at Month 6.|Wilcoxon test|||||||<0.0001
72433406|NCT01664104|144380018|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-value was calculated between baseline versus change at Month 3.|Wilcoxon test|||||||<0.0001
72433407|NCT01664104|144380018|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-value was calculated between baseline versus change at Month 6.|Wilcoxon test|||||||<0.0001
72433408|NCT01664104|144380019|SUPERIORITY_OR_OTHER|||||||0.6904|||||||t-test|P-value signifies CRP at the start of TCZ treatment by remission status using DAS28-CRP (remission versus no remission).||||||0.6904
72433409|NCT01664104|144380019|SUPERIORITY_OR_OTHER|||||||0.6032|||||||t-test|P-value signifies the CRP at the start of TCZ treatment by remission status using SDAI (remission versus no remission).||||||0.6032
72433410|NCT01664104|144380019|SUPERIORITY_OR_OTHER|||||||0.6146|||||||t-test|P-value signifies the CRP at the start of TCZ treatment by remission status using CDAI (remission versus no remission).||||||0.6146
72433411|NCT01664104|144380020|SUPERIORITY_OR_OTHER|||||||0.0018|||||||t-test|P-value signifies the BMI at the start of TCZ treatment by remission status using DAS28-CRP (remission versus no remission).||||||0.0018
72433412|NCT01664104|144380020|SUPERIORITY_OR_OTHER|||||||0.1617|||||||t-test|P-value signifies the BMI at the start of TCZ treatment by remission status using SDAI (remission versus no remission).||||||0.1617
72433413|NCT01664104|144380020|SUPERIORITY_OR_OTHER|||||||0.1296|||||||t-test|P-value signifies the BMI at the start of TCZ treatment by remission status using CDAI (remission versus no remission).||||||0.1296
72433414|NCT01664104|144380023|SUPERIORITY_OR_OTHER|||||||0.5332|||||||t-test|P-value signifies the CRP at the start of TCZ treatment using the morning stiffness ( ≤ 30 minutes versus \> 30 minutes).||||||0.5332
72555604|NCT03100344|144642385|SUPERIORITY||mean difference of percentage changes|-23.8|||<|0.001|TWO_SIDED|95.0|-34.0|-13.6|||Kenward Roger|||Week 2||-13.6|-34.0|<0.001
72433415|NCT01664104|144380024|SUPERIORITY_OR_OTHER|||||||0.6159|||||||t-test|P-value signifies the BMI at the start of TCZ treatment using the morning stiffness ( ≤ 30 minutes versus \> 30 minutes).||||||0.6159
72433416|NCT01664104|144380025|SUPERIORITY_OR_OTHER|||||||0.237|||||||Pearson correlation|P-value was calculated from Pearson correlation coefficient between CRP at the start of TCZ treatment versus HAQ-DI (0-3) at Month 6.||||||0.2370
72433417|NCT01664104|144380025|SUPERIORITY_OR_OTHER|||||||0.8033|||||||Spearman Correlation|P-value was calculated from Spearman correlation coefficient between CRP at the start of TCZ treatment versus HAQ-D1 (0-3) at Month 6.||||||0.8033
72433418|NCT01664104|144380026|SUPERIORITY_OR_OTHER|||||||0.0306|||||||Pearson correlation|P-value was calculated from Pearson correlation coefficient for change from baseline in CRP versus change from baseline in HAQ-DI (0-3) at Month 6.||||||0.0306
72374250|NCT03595618|144258783|SUPERIORITY||Adjusted mean difference|-1.2|STANDARD_ERROR_OF_MEAN|1.3||0.665|TWO_SIDED|95.0|-3.7|1.3||Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05).|Mixed Models Analysis||Two-sided 95% Confidence Interval of the estimate without Dunnett adjustment.|Physical Function subscore: Estimate (Standard Error) of adjusted difference from baseline to last post baseline value between treatment groups means: placebo minus GLPG1972 dose using MMRM including fixed, categorical effects of treatment, region (Asia and Rest of the World), time and treatment-by-time interaction, as well as continuous, fixed covariates of baseline and time-by-baseline interaction preceded by multiple imputation step for participants without post baseline value.||1.3|-3.7|0.665
72374251|NCT03595618|144258783|SUPERIORITY||Adjusted mean difference|-1.3|STANDARD_ERROR_OF_MEAN|1.3||0.598|TWO_SIDED|95.0|-3.9|1.2||Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05).|Mixed Models Analysis||Two-sided 95% Confidence Interval of the estimate without Dunnett adjustment.|Physical Function subscore: Estimate (Standard Error) of adjusted difference from baseline to last post baseline value between treatment groups means: placebo minus GLPG1972 dose using MMRM including fixed, categorical effects of treatment, region (Asia and Rest of the World), time and treatment-by-time interaction, as well as continuous, fixed covariates of baseline and time-by-baseline interaction preceded by multiple imputation step for participants without post baseline value.||1.2|-3.9|0.598
72374252|NCT03595618|144258783|SUPERIORITY||Adjusted mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.2||0.4|TWO_SIDED|95.0|-0.6|0.1||Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05)|Mixed Models Analysis||Two-sided 95% Confidence Interval of the estimate without Dunnett adjustment|Stiffness subscore: Estimate (Standard Error) of adjusted difference from baseline to last post baseline value between treatment groups means: placebo minus GLPG1972 dose using MMRM including fixed, categorical effects of treatment, region (Asia and Rest of the World), time and treatment-by-time interaction, as well as continuous, fixed covariates of baseline and time-by-baseline interaction preceded by multiple imputation step for participants without post baseline value.||0.1|-0.6|0.400
72374253|NCT03595618|144258783|SUPERIORITY||Adjusted mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.2||0.393|TWO_SIDED|95.0|-0.6|0.1||Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05)|Mixed Models Analysis||Two-sided 95% Confidence Interval of the estimate without Dunnett adjustment|Stiffness subscore: Estimate (Standard Error) of adjusted difference from baseline to last post baseline value between treatment groups means: placebo minus GLPG1972 dose using MMRM including fixed, categorical effects of treatment, region (Asia and Rest of the World), time and treatment-by-time interaction, as well as continuous, fixed covariates of baseline and time-by-baseline interaction preceded by multiple imputation step for participants without post baseline value.||0.1|-0.6|0.393
72395055|NCT00720434|144296637|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-2.4919||||0.0142|TWO_SIDED|95.0|-4.44619|-0.5376|||ANCOVA|||An ANCOVA model was used to compare differences among treatments. Independent variables included treatment and log-transformed baseline HCV viral load. Adjusted mean difference and corresponding 95% CI were calculated.||-0.53760|-4.44619|0.0142
72433419|NCT01664104|144380026|SUPERIORITY_OR_OTHER|||||||0.0749|||||||Spearman Correlation|P-value was calculated from Spearman correlation coefficient for change from baseline in CRP versus change from baseline in HAQ-DI (0-3) at Month 6.||||||0.0749
72433420|NCT01664104|144380027|SUPERIORITY_OR_OTHER|||||||0.4854|||||||Pearson correlation|P-value was calculated from Pearson correlation coefficient between CRP at the start of TCZ treatment versus VAS fatigue at Month 6.||||||0.4854
72433421|NCT01664104|144380027|SUPERIORITY_OR_OTHER|||||||0.325|||||||S|P-value was calculated from Spearman correlation coefficient between CRP at the start of TCZ treatment versus VAS fatigue at Month 6.||||||0.3250
72433422|NCT01664104|144380028|SUPERIORITY_OR_OTHER|||||||0.0011|||||||Pearson correlation|P-value was calculated from Pearson correlation coefficient between change from baseline in CRP versus change from baseline in VAS fatigue at Month 6.||||||0.0011
72433423|NCT01664104|144380028|SUPERIORITY_OR_OTHER|||||||0.0013|||||||Spearman Correlation|P-value calculated from Spearman correlation coefficient between change from baseline in CRP versus change from baseline in VAS fatigue at Month 6.||||||0.0013
72433424|NCT01664104|144380029|SUPERIORITY_OR_OTHER|||||||0.5655|||||||Pearson correlation|P-value was calculated from Pearson correlation coefficient between BMI at the start of TCZ treatment versus HAQ-DI (0-3) at Month 6.||||||0.5655
72433425|NCT01664104|144380029|SUPERIORITY_OR_OTHER|||||||0.3977|||||||Spearman Correlation|P-value was calculated from Spearman correlation coefficient between BMI at the start of TCZ treatment versus HAQ-DI (0-3) at Month 6.||||||0.3977
72433426|NCT01664104|144380030|SUPERIORITY_OR_OTHER|||||||0.0123|||||||Pearson correlation|P-value obtained from Pearson correlation coefficient between change from baseline in CRP versus change from baseline in morning stiffness at Month 6.||||||0.0123
72433427|NCT01664104|144380030|SUPERIORITY_OR_OTHER|||||||0.0151|||||||Spearman Correlation|P-value obtained from Spearman correlation coefficient between change from baseline in CRP versus change from baseline in morning stiffness at Month 6||||||0.0151
72433428|NCT01664104|144380031|SUPERIORITY_OR_OTHER|||||||0.9909|||||||Pearson correlation|P-value was calculated from Pearson correlation coefficient between BMI at the start of TCZ treatment versus VAS fatigue at Month 6.||||||0.9909
72555605|NCT03100344|144642385|SUPERIORITY||mean difference of percentage changes|-21.3|||<|0.001|TWO_SIDED|95.0|-32.1|-10.5|||Kenward Roger|||Week 4||-10.5|-32.1|<0.001
72433429|NCT01664104|144380031|SUPERIORITY_OR_OTHER|||||||0.6482|||||||Spearman Correlation|P-value was calculated from Spearman correlation coefficient between BMI at the start of TCZ treatment versus VAS fatigue at Month 6.||||||0.6482
72433430|NCT02107014|144380034|SUPERIORITY_OR_OTHER|||||||0.576|||||||Mixed Models Analysis|||||||.576
72433431|NCT02107014|144380035|SUPERIORITY_OR_OTHER|||||||0.01|||||||Mixed Models Analysis|||||||0.010
72433432|NCT02107014|144380036|SUPERIORITY_OR_OTHER|||||||0.008|||||||Mixed Models Analysis|||||||.008
72433433|NCT02107014|144380037|SUPERIORITY_OR_OTHER|||||||0.015|||||||Mixed Models Analysis|||||||.015
72433434|NCT02107014|144380038|SUPERIORITY_OR_OTHER|||||||0.007|||||||Mixed Models Analysis|||||||.007
72433435|NCT02107014|144380039|SUPERIORITY_OR_OTHER|||||||0.016|||||||Mixed Models Analysis|||||||.016
72433436|NCT02107014|144380040|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
72433437|NCT02107014|144380041|SUPERIORITY_OR_OTHER|||||||0.212|||||||Mixed Models Analysis|||||||0.212
72433438|NCT02107014|144380044|SUPERIORITY_OR_OTHER|||||||0.008|||||||Mixed Models Analysis|||||||0.008
72433439|NCT02107014|144380045|SUPERIORITY_OR_OTHER|||||||0.004|||||||Mixed Models Analysis|||||||0.004
72433440|NCT02107014|144380046|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
72433441|NCT02107014|144380047|SUPERIORITY_OR_OTHER|||||||0.047|||||||Mixed Models Analysis|||||||0.047
72433442|NCT02107014|144380048|SUPERIORITY_OR_OTHER|||||||0.002|||||||Mixed Models Analysis|||||||0.002
72433443|NCT02107014|144380049|SUPERIORITY_OR_OTHER|||||||0.003|||||||Mixed Models Analysis|||||||0.003
72433444|NCT02107014|144380050|SUPERIORITY_OR_OTHER|||||||0.191|||||||Mixed Models Analysis|||||||0.191
72433445|NCT02107014|144380051|SUPERIORITY_OR_OTHER|||||||0.088|||||||Mixed Models Analysis|||||||0.088
72433446|NCT02107014|144380052|SUPERIORITY_OR_OTHER|||||||0.478|||||||Mixed Models Analysis|||||||0.478
72433447|NCT02107014|144380055|SUPERIORITY_OR_OTHER|||||||0.016|||||||Mixed Models Analysis|||||||0.016
72433448|NCT02107014|144380056|SUPERIORITY_OR_OTHER|||||||0.025|||||||Mixed Models Analysis|||||||0.025
72433449|NCT02107014|144380057|SUPERIORITY_OR_OTHER|||||||0.012|||||||Mixed Models Analysis|||||||0.012
72433450|NCT02107014|144380058|SUPERIORITY_OR_OTHER|||||||0.426|||||||Mixed Models Analysis|||||||0.426
72433451|NCT02107014|144380059|SUPERIORITY_OR_OTHER|||||||0.042|||||||Mixed Models Analysis|||||||0.042
72433452|NCT02107014|144380060|SUPERIORITY_OR_OTHER|||||||0.708|||||||Mixed Models Analysis|||||||0.708
72433453|NCT02107014|144380061|SUPERIORITY_OR_OTHER|||||||0.558|||||||Mixed Models Analysis|||||||0.558
72433454|NCT02107014|144380062|SUPERIORITY_OR_OTHER|||||||0.35|||||||Mixed Models Analysis|||||||0.350
72433455|NCT02107014|144380063|SUPERIORITY_OR_OTHER|||||||0.655|||||||Mixed Models Analysis|||||||0.655
72433456|NCT02107014|144380064|SUPERIORITY_OR_OTHER|||||||0.248|||||||Mixed Models Analysis|||||||0.248
72433457|NCT02107014|144380065|SUPERIORITY_OR_OTHER|||||||0.128|||||||Mixed Models Analysis|||||||0.128
72433458|NCT02107014|144380066|SUPERIORITY_OR_OTHER|||||||0.065|||||||Mixed Models Analysis|||||||0.065
72433459|NCT02107014|144380067|SUPERIORITY_OR_OTHER|||||||0.962|||||||Mixed Models Analysis|||||||0.962
72433460|NCT02107014|144380068|SUPERIORITY_OR_OTHER|||||||0.402|||||||Mixed Models Analysis|||||||0.402
72433461|NCT02107014|144380069|SUPERIORITY_OR_OTHER|||||||0.201|||||||Mixed Models Analysis|||||||0.201
72433462|NCT02107014|144380070|SUPERIORITY_OR_OTHER|||||||0.016|||||||Mixed Models Analysis|||||||0.016
72433463|NCT02107014|144380071|SUPERIORITY_OR_OTHER|||||||0.006|||||||Mixed Models Analysis|||||||0.006
72433464|NCT02107014|144380072|SUPERIORITY_OR_OTHER|||||||0.007|||||||Mixed Models Analysis|||||||0.007
72433465|NCT02107014|144380073|SUPERIORITY_OR_OTHER|||||||0.038|||||||Mixed Models Analysis|||||||0.038
72433466|NCT02107014|144380074|SUPERIORITY_OR_OTHER|||||||0.032|||||||Mixed Models Analysis|||||||0.032
72433467|NCT02107014|144380075|SUPERIORITY_OR_OTHER|||||||0.002|||||||Mixed Models Analysis|||||||0.002
72433468|NCT02107014|144380077|SUPERIORITY_OR_OTHER|||||||0.508|||||||Mixed Models Analysis|||||||0.508
72433469|NCT02107014|144380078|SUPERIORITY_OR_OTHER|||||||0.119|||||||Mixed Models Analysis|||||||0.119
72433470|NCT02107014|144380079|SUPERIORITY_OR_OTHER|||||||0.326|||||||Mixed Models Analysis|||||||0.326
72433471|NCT02107014|144380080|SUPERIORITY_OR_OTHER|||||||0.753|||||||Mixed Models Analysis|||||||0.753
72433472|NCT02107014|144380081|SUPERIORITY_OR_OTHER|||||||0.067|||||||Mixed Models Analysis|||||||0.067
72433473|NCT02107014|144380082|SUPERIORITY_OR_OTHER|||||||0.08|||||||Mixed Models Analysis|||||||0.080
72433474|NCT02107014|144380083|SUPERIORITY_OR_OTHER|||||||0.639|||||||Mixed Models Analysis|||||||0.639
72433475|NCT02107014|144380086|SUPERIORITY_OR_OTHER|||||||0.945|||||||Mixed Models Analysis|||||||0.945
72433476|NCT02107014|144380087|SUPERIORITY_OR_OTHER|||||||0.038|||||||Mixed Models Analysis|||||||0.038
72433477|NCT02107014|144380088|SUPERIORITY_OR_OTHER|||||||0.281|||||||Mixed Models Analysis|||||||0.281
72433478|NCT02107014|144380089|SUPERIORITY_OR_OTHER|||||||0.03|||||||Mixed Models Analysis|||||||0.030
72433479|NCT02107014|144380090|SUPERIORITY_OR_OTHER|||||||0.948|||||||Mixed Models Analysis|||||||0.948
72433480|NCT02107014|144380091|SUPERIORITY_OR_OTHER|||||||0.61|||||||Mixed Models Analysis|||||||0.610
72433481|NCT02107014|144380092|SUPERIORITY_OR_OTHER|||||||0.893|||||||Mixed Models Analysis|||||||0.893
72433482|NCT02107014|144380093|SUPERIORITY_OR_OTHER|||||||0.041|||||||Mixed Models Analysis|||||||0.041
72433483|NCT02107014|144380096|SUPERIORITY_OR_OTHER|||||||0.967|||||||Mixed Models Analysis|||||||0.967
72433484|NCT02107014|144380097|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
72433485|NCT02107014|144380098|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
72433486|NCT03582956|144380146|SUPERIORITY|||||||0.525|||||||t-test, 2 sided|||||||0.525
72433487|NCT03582956|144380147|SUPERIORITY|||||||0.607|||||||t-test, 2 sided|||||||0.607
72433488|NCT03582956|144380148|SUPERIORITY|||||||0.466|||||||t-test, 2 sided|||||||0.466
72555606|NCT03100344|144642385|SUPERIORITY||mean difference of percentage changes|-34.8|||<|0.001|TWO_SIDED|95.0|-45.5|-24.2|||Kenward Roger|||Week 4||-24.2|-45.5|<0.001
72555607|NCT03100344|144642385|SUPERIORITY||mean difference of percentage changes|-30.7|||<|0.001|TWO_SIDED|95.0|-41.6|-19.9|||Kenward Roger|||Week 4||-19.9|-41.6|<0.001
72433489|NCT03582956|144380149|SUPERIORITY|||||||0.414|||||||t-test, 2 sided|||||||0.414
72433490|NCT00517933|144380197|SUPERIORITY_OR_OTHER|||||||0.39|||||||Chi-squared|||||||0.39
72493780|NCT02889796|144516572|SUPERIORITY||Least Squares Mean Difference|-10.0|STANDARD_ERROR_OF_MEAN|1.5|<|0.001|TWO_SIDED|95.0|-13.0|-7.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-7.0|-13.0|<0.001
72493781|NCT02889796|144516572|SUPERIORITY||Least Squares Mean Difference|-11.0|STANDARD_ERROR_OF_MEAN|1.6|<|0.001|TWO_SIDED|95.0|-14.0|-7.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-7.0|-14.0|<0.001
72493782|NCT02889796|144516572|SUPERIORITY||Least Squares Mean Difference|-9.0|STANDARD_ERROR_OF_MEAN|1.6|<|0.001|TWO_SIDED|95.0|-12.0|-6.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-6.0|-12.0|<0.001
72493783|NCT02889796|144516574|SUPERIORITY||Least Squares Mean Difference|-10.83|STANDARD_ERROR_OF_MEAN|0.952|<|0.001|TWO_SIDED|95.0|-12.7|-8.96||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-8.96|-12.70|<0.001
72493784|NCT02889796|144516574|SUPERIORITY||Least Squares Mean Difference|-7.73|STANDARD_ERROR_OF_MEAN|0.947|<|0.001|TWO_SIDED|95.0|-9.58|-5.87||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-5.87|-9.58|<0.001
72493785|NCT02889796|144516574|SUPERIORITY||Least Squares Mean Difference|-9.39|STANDARD_ERROR_OF_MEAN|0.989|<|0.001|TWO_SIDED|95.0|-11.33|-7.45||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-7.45|-11.33|<0.001
72493786|NCT02889796|144516574|SUPERIORITY||Least Squares Mean Difference|-7.35|STANDARD_ERROR_OF_MEAN|0.987|<|0.001|TWO_SIDED|95.0|-9.29|-5.42||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-5.42|-9.29|<0.001
72493787|NCT02889796|144516574|SUPERIORITY||Least Squares Mean Difference|-8.02|STANDARD_ERROR_OF_MEAN|0.961|<|0.001|TWO_SIDED|95.0|-9.9|-6.13||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-6.13|-9.90|<0.001
72493788|NCT02889796|144516574|SUPERIORITY||Least Squares Mean Difference|-6.46|STANDARD_ERROR_OF_MEAN|0.96|<|0.001|TWO_SIDED|95.0|-8.35|-4.58||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-4.58|-8.35|<0.001
72493789|NCT02889796|144516574|SUPERIORITY||Least Squares Mean Difference|-7.91|STANDARD_ERROR_OF_MEAN|1.007|<|0.001|TWO_SIDED|95.0|-9.88|-5.93||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-5.93|-9.88|<0.001
72504473|NCT00984659|144539580|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.13|||<|0.001||95.0|0.08|0.18||ANCOVA adjusted for age, gender, and SOBDA Baseline score; difference between responders and non-responders during Week prior to Day 36|ANCOVA|||||0.18|0.08|<0.001
72433491|NCT00517933|144380199|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.7||||0.11|TWO_SIDED|95.0|-3.9|37.3|||Regression, Linear|||||37.3|-3.9|0.11
72433492|NCT00517933|144380200|SUPERIORITY_OR_OTHER|||||||0.41|TWO_SIDED||||||Log Rank|||||||0.41
72433493|NCT00517933|144380201|SUPERIORITY_OR_OTHER||Slope|-6.58|STANDARD_ERROR_OF_MEAN|2.3||0.006|TWO_SIDED|95.0|-11.25|-1.92|||Mixed Models Analysis|||||-1.92|-11.25|0.006
72433494|NCT00517933|144380203|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01||||0.7|TWO_SIDED|95.0|-0.05|0.07|||Mixed Models Analysis|||||0.07|-0.05|0.70
72433495|NCT00517933|144380205|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.6||||0.04|TWO_SIDED|95.0|0.1|3.0|||Mixed Models Analysis|||||3.0|0.1|0.04
72433496|NCT00517933|144380207|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.34||||0.16|TWO_SIDED|95.0|-0.81|0.14|||Regression, Linear|||||0.14|-0.81|0.16
72433497|NCT00517933|144380209|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.1||||0.01|TWO_SIDED|95.0|-7.3|-0.9|||Regression, Linear|||||-0.9|-7.3|0.01
72433498|NCT00517933|144380211|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.7||||0.02|TWO_SIDED|95.0|-10.6|-0.9|||Regression, Linear|||||-0.9|-10.6|0.02
72374254|NCT03595618|144258783|SUPERIORITY||Adjusted mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.2||0.858|TWO_SIDED|95.0|-0.5|0.2||Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05)|Mixed Models Analysis||Two-sided 95% Confidence Interval of the estimate without Dunnett adjustment|Stiffness subscore: Estimate (Standard Error) of adjusted difference from baseline to last post baseline value between treatment groups means: placebo minus GLPG1972 dose using MMRM including fixed, categorical effects of treatment, region (Asia and Rest of the World), time and treatment-by-time interaction, as well as continuous, fixed covariates of baseline and time-by-baseline interaction preceded by multiple imputation step for participants without post baseline value.||0.2|-0.5|0.858
72374255|NCT03595618|144258784|SUPERIORITY||Adjusted mean difference|-2.2|STANDARD_ERROR_OF_MEAN|2.5||0.705|TWO_SIDED|95.0|-7.1|2.7||Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05).|Mixed Models Analysis||Two-sided 95% Confidence Interval of the estimate without Dunnett adjustment.|Estimate (Standard Error) of the adjusted difference from baseline to last post baseline value between treatment groups means: placebo minus GLPG1972 dose regimen using a MMRM including the fixed, categorical effects of treatment, region (Asia and Rest of the World), time and treatment-by-time interaction, as well as the continuous, fixed covariates of baseline and time-by-baseline interaction preceded by a Multiple Imputation step for participants without post-baseline measurement.||2.7|-7.1|0.705
72374256|NCT03595618|144258784|SUPERIORITY||Adjusted mean difference|-4.1|STANDARD_ERROR_OF_MEAN|2.5||0.243|TWO_SIDED|95.0|-9.0|0.8||Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05).|Mixed Models Analysis||Two-sided 95% Confidence Interval of the estimate without Dunnett adjustment.|Estimate (Standard Error) of the adjusted difference from baseline to last post baseline value between treatment groups means: placebo minus GLPG1972 dose regimen using a MMRM including the fixed, categorical effects of treatment, region (Asia and Rest of the World), time and treatment-by-time interaction, as well as the continuous, fixed covariates of baseline and time-by-baseline interaction preceded by a Multiple Imputation step for participants without post-baseline measurement.||0.8|-9.0|0.243
72374257|NCT03595618|144258784|SUPERIORITY||Adjusted mean difference|-1.1|STANDARD_ERROR_OF_MEAN|2.5||0.949|TWO_SIDED|95.0|-6.1|3.9||Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05).|Mixed Models Analysis||Two-sided 95% Confidence Interval of the estimate without Dunnett adjustment.|Estimate (Standard Error) of the adjusted difference from baseline to last post baseline value between treatment groups means: placebo minus GLPG1972 dose regimen using a MMRM including the fixed, categorical effects of treatment, region (Asia and Rest of the World), time and treatment-by-time interaction, as well as the continuous, fixed covariates of baseline and time-by-baseline interaction preceded by a Multiple Imputation step for participants without post-baseline measurement.||3.9|-6.1|0.949
72374258|NCT03595618|144258785|SUPERIORITY||Adjusted mean difference|1.4|STANDARD_ERROR_OF_MEAN|2.5||0.89|TWO_SIDED|95.0|-3.4|6.3||Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05).|Mixed Models Analysis||Two-sided 95% Confidence Interval of the estimate without Dunnett adjustment.|Estimate (Standard Error) of the adjusted difference from baseline to last post baseline value between treatment groups means: GLPG1972 dose regimen minus placebo using a MMRM including the fixed, categorical effects of treatment, region (Asia and Rest of the World), time and treatment-by-time interaction, as well as the continuous, fixed covariates of baseline and time-by-baseline interaction preceded by a Multiple Imputation step for participants without post-baseline measurement.||6.3|-3.4|0.890
72374259|NCT03595618|144258785|SUPERIORITY||Adjusted mean difference|-2.3|STANDARD_ERROR_OF_MEAN|2.5||0.682|TWO_SIDED|95.0|-7.1|2.6||Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05).|Mixed Models Analysis||Two-sided 95% Confidence Interval of the estimate without Dunnett adjustment.|Estimate (Standard Error) of the adjusted difference from baseline to last post baseline value between treatment groups means: GLPG1972 dose regimen minus placebo using a MMRM including the fixed, categorical effects of treatment, region (Asia and Rest of the World), time and treatment-by-time interaction, as well as the continuous, fixed covariates of baseline and time-by-baseline interaction preceded by a Multiple Imputation step for participants without post-baseline measurement.||2.6|-7.1|0.682
72374260|NCT03595618|144258785|SUPERIORITY||Adjusted mean difference|0.1|STANDARD_ERROR_OF_MEAN|2.5||1|TWO_SIDED|95.0|-4.8|5.0||Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05).|Mixed Models Analysis||Two-sided 95% Confidence Interval of the estimate without Dunnett adjustment.|Estimate (Standard Error) of the adjusted difference from baseline to last post baseline value between treatment groups means: GLPG1972 dose regimen minus placebo using a MMRM including the fixed, categorical effects of treatment, region (Asia and Rest of the World), time and treatment-by-time interaction, as well as the continuous, fixed covariates of baseline and time-by-baseline interaction preceded by a Multiple Imputation step for participants without post-baseline measurement.||5.0|-4.8|1.000
72374261|NCT03595618|144258786|SUPERIORITY||Odds Ratio (OR)|1.05|STANDARD_ERROR_OF_MEAN|0.21||0.991|TWO_SIDED|95.0|0.7|1.58||Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05).|Logistic Model||Two-sided 95% Confidence Interval of the estimate without Dunnett adjustment.|Estimate (Standard Error of log \[estimate\]) of the adjusted odds ratio between GLPG1972 dose regimen and placebo: between the proportions of participants with response: placebo versus GLPG1972 dose regimen.||1.58|0.70|0.991
72433499|NCT00517933|144380213|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.6||||0.04|TWO_SIDED|95.0|-7.2|-0.1|||Regression, Linear|||||-0.1|-7.2|0.04
72433500|NCT00517933|144380215|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.7||||0.07|TWO_SIDED|95.0|-7.8|0.4|||Regression, Logistic|||||0.4|-7.8|0.07
72433501|NCT00517933|144380217|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.02||||0.18|TWO_SIDED|95.0|-0.01|0.06|||Regression, Linear|||||0.06|-0.01|0.18
72433502|NCT00517933|144380219|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.3||||0.37|TWO_SIDED|95.0|-2.8|7.3|||Regression, Linear|||||7.3|-2.8|0.37
72433503|NCT00517933|144380223|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.9||||0.008|TWO_SIDED|95.0|0.8|5.0|||Regression, Linear|||||5.0|0.8|0.008
72433504|NCT00517933|144380225|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2||||0.86|TWO_SIDED|95.0|-2.1|1.7|||Regression, Linear|||||1.7|-2.1|0.86
72504474|NCT00984659|144539580|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.06||||0.18||95.0|-0.03|0.15||ANCOVA adjusted for age, gender, and SOBDA Baseline score; difference between responders and non-responders during Week prior to Day 43|ANCOVA|||||0.15|-0.03|0.180
72433505|NCT01639443|144380233|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||"We counted days containing at least one Fast-tracked participant as a Fast-tracked day for the sake of analysis at the clinic level. Our null hypothesis is that these days will not differ in terms of percentage of clinic capacity filled. We are powered to detect a 0.5 Standard Deviation (SD) difference in clinic capacity (Type I error rate = 5%; Power = 81%), with a equal ratio of Experimental and Control days."||||<0.0001
72433506|NCT01639443|144380234|SUPERIORITY_OR_OTHER|||||||0.29|||||||t-test, 2 sided|||We calculated this measure on the patient level. Our null hypothesis is that the lag time between scheduling and appointment, measured in days, will not differ between groups. We are powered to detect a 0.3 SD difference in lag time (Type I error rate = 5%; Power = 84%), accounting for the large sampling ratio (approximately 14:1).||||0.29
72433507|NCT01639443|144380235|SUPERIORITY_OR_OTHER|||||||0.49||||||We would have only expected 2 patients to be bumped in the Experimental Group, and observed 0.|Fisher Exact|||We did not explicitly power this study to detect differences in the number of service bumps, but we can compare them using Fisher's Exact Test||||0.49
72433508|NCT01639443|144380236|SUPERIORITY_OR_OTHER|||||||0.05|||||||t-test, 2 sided|||We calculated this measure on the patient level, but were hampered by a large sampling ratio (more than 50:1). Our null hypothesis is that the number of polyps detected will not differ between groups. We are powered to detect a 0.25 SD difference in polyp count per patient (Type I error rate = 5%; Power = 80%).||||0.05
72433509|NCT01639443|144380237|SUPERIORITY_OR_OTHER|||||||0.024|||||||t-test, 2 sided|||"We counted days containing at least one Fast-tracked participant as a Fast-tracked day for the sake of analysis at the clinic level. Our null hypothesis is that these days will not differ in terms of length of workday. We are powered to detect approximately 0.5 SD difference in workday length in hours (Type I error rate = 5%; Power = 81%), with a equal ratio of Experimental and Control days."||||0.024
72433510|NCT01639443|144380238|SUPERIORITY_OR_OTHER|||||||0.11|||||||t-test, 2 sided|||"We counted days containing at least one Fast-tracked participant as a Fast-tracked day for the sake of analysis at the clinic level. Our null hypothesis is that these days will not differ in terms of cost per day. We are powered to detect a 0.5 SD difference in clinic capacity (Type I error rate = 5%; Power = 81%), with a equal ratio of Experimental and Control days."||||0.11
72433511|NCT01649427|144380247|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority||||||0.0003|||||||ANCOVA|||||||0.0003
72433512|NCT04888585|144380253|SUPERIORITY||Response Rate Difference|21.2|||<|0.001|TWO_SIDED|95.0|11.5|31.0|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted for the stratification factors.|Response Rate Difference = ABBV-154 40mg EOW - Placebo|||31.0|11.5|<0.001
72433513|NCT04888585|144380253|SUPERIORITY||Response Rate Difference|26.6|||<|0.001|TWO_SIDED|95.0|16.5|36.7|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted for the stratification factors.|Response Rate Difference = ABBV-154 150mg EOW - Placebo|||36.7|16.5|<0.001
72433514|NCT04888585|144380253|SUPERIORITY||Response Rate Difference|37.7|||<|0.001|TWO_SIDED|95.0|27.4|48.1|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted for the stratification factors.|Response Rate Difference = ABBV-154 340mg EOW - Placebo|||48.1|27.4|<0.001
72433515|NCT04888585|144380253|SUPERIORITY||Response Rate Difference|23.2|||<|0.001|TWO_SIDED|95.0|13.8|32.6|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted for the stratification factors.|Response Rate Difference = ABBV-154 340mg E4W - Placebo|||32.6|13.8|<0.001
72433516|NCT04888585|144380254|SUPERIORITY||Least Squares (LS) Mean Difference|-0.51||||0.007|TWO_SIDED|95.0|-0.87|-0.14|||Mixed Models Analysis|MMRM includes treatment, visit, treatment-by-visit interaction, stratification factors, and the baseline measurement as covariates.|Response Rate Difference = ABBV-154 40mg - Placebo|||-0.14|-0.87|0.007
72433517|NCT04888585|144380254|SUPERIORITY||Least Squares (LS) Mean Difference|-1.01|||<|0.001|TWO_SIDED|95.0|-1.38|-0.64|||Mixed Models Analysis|MMRM model includes treatment, visit, treatment-by-visit interaction, stratification factors, and the baseline measurement as covariates.|Response Rate Difference = ABBV-154 150mg EOW - Placebo|||-0.64|-1.38|<0.001
72433518|NCT04888585|144380254|SUPERIORITY||Least Squares (LS) Mean Difference|-1.42|||<|0.001|TWO_SIDED|95.0|-1.8|-1.05|||Mixed Models Analysis|MMRM model includes treatment, visit, treatment-by-visit interaction, stratification factors, and the baseline measurement as covariates.|Response Rate Difference = ABBV-154 340mg EOW - Placebo|||-1.05|-1.80|<0.001
72433519|NCT04888585|144380254|SUPERIORITY||Least Squares (LS) Mean Difference|-0.62|||<|0.001|TWO_SIDED|95.0|-0.99|-0.26|||Mixed Models Analysis|MMRM model includes treatment, visit, treatment-by-visit interaction, stratification factors, and the baseline measurement as covariates.|Response Rate Difference = ABBV-154 340 E4W - Placebo|||-0.26|-0.99|<0.001
72504475|NCT00984659|144539580|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.08||||0.307||95.0|-0.07|0.23||ANCOVA adjusted for age, gender, and SOBDA Baseline score; difference between responders and non-responders during Week prior to Visit 3/PD|ANCOVA|||||0.23|-0.07|0.307
72504476|NCT00984659|144539584|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.24|||<|0.001||95.0|0.14|0.34||ANCOVA adjusted for age, gender, and SOBDA Baseline score; comparision of mean SOBDA score for CGI-C responders and non-responders|ANCOVA|||||0.34|0.14|<0.001
72504477|NCT00984659|144539585|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.3|||<|0.001|TWO_SIDED|95.0|0.21|0.4||ANCOVA adjusted for age, gender, and SOBDA Baseline score; comparision of mean SOBDA score for CRQ-SAS Dyspnea Domain responders and non-responders|ANCOVA|||||0.40|0.21|<0.001
72493790|NCT02889796|144516574|SUPERIORITY||Least Squares Mean Difference|-6.59|STANDARD_ERROR_OF_MEAN|1.005|<|0.001|TWO_SIDED|95.0|-8.56|-4.62||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-4.62|-8.56|<0.001
72493791|NCT02889796|144516576|SUPERIORITY||Difference in Response Rates|12.3|||<|0.001|TWO_SIDED|95.0|5.7|18.9||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg vs Placebo at Week 2.||18.9|5.7|<0.001
72493792|NCT02889796|144516576|SUPERIORITY||Difference in Response Rates|6.5||||0.043|TWO_SIDED|95.0|-0.1|13.1||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg vs Placebo at Week 2.||13.1|-0.1|0.043
72493793|NCT02889796|144516576|SUPERIORITY||Difference in Response Rates|16.3|||<|0.001|TWO_SIDED|95.0|9.8|22.8||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg vs Placebo at Week 4.||22.8|9.8|<0.001
72493794|NCT02889796|144516576|SUPERIORITY||Difference in Response Rates|8.1||||0.011|TWO_SIDED|95.0|1.5|14.7||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg vs Placebo at Week 4.||14.7|1.5|0.011
72493795|NCT02889796|144516576|SUPERIORITY||Difference in Response Rates|21.0|||<|0.001|TWO_SIDED|95.0|14.9|27.0||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg vs Placebo at Week 12.||27.0|14.9|<0.001
72493796|NCT02889796|144516576|SUPERIORITY||Difference in Response Rates|13.6|||<|0.001|TWO_SIDED|95.0|7.3|19.9||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg vs Placebo at Week 12.||19.9|7.3|<0.001
72493797|NCT02889796|144516576|SUPERIORITY||Difference in Response Rates|16.6|||<|0.001|TWO_SIDED|95.0|10.5|22.8||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg vs Placebo at Week 24.||22.8|10.5|<0.001
72493798|NCT02889796|144516576|SUPERIORITY||Difference in Response Rates|14.1|||<|0.001|TWO_SIDED|95.0|7.8|20.3||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg vs Placebo at Week 24.||20.3|7.8|<0.001
72493799|NCT02889796|144516578|SUPERIORITY||Least Squares Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.06|<|0.001|TWO_SIDED|95.0|-0.9|-0.6||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.6|-0.9|<0.001
72493800|NCT02889796|144516578|SUPERIORITY||Least Squares Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.06|<|0.001|TWO_SIDED|95.0|-0.5|-0.3||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.3|-0.5|<0.001
72493801|NCT02889796|144516578|SUPERIORITY||Least Squares Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|95.0|-0.9|-0.7||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.7|-0.9|<0.001
72493802|NCT02889796|144516578|SUPERIORITY||Least Squares Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|95.0|-0.7|-0.4||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.4|-0.7|<0.001
72493803|NCT02889796|144516578|SUPERIORITY||Least Squares Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|95.0|-1.1|-0.8||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.8|-1.1|<0.001
72493804|NCT02889796|144516578|SUPERIORITY||Least Squares Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|95.0|-0.8|-0.5||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.5|-0.8|<0.001
72493805|NCT02889796|144516578|SUPERIORITY||Least Squares Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-1.1|-0.8||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.8|-1.1|<0.001
72504478|NCT00984659|144539586|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.03||||0.535||95.0|-0.08|0.15||ANCOVA adjusted for age, gender, and SOBDA Baseline score; comparision of mean SOBDA score for Physician-Completed mMRC responders and non-responders|ANCOVA|||||0.15|-0.08|0.535
72555608|NCT03100344|144642385|SUPERIORITY||mean difference of percentage changes|-22.9|||<|0.001|TWO_SIDED|95.0|-33.2|-12.6|||Kenward Roger|||Week 8||-12.6|-33.2|<0.001
72493806|NCT02889796|144516578|SUPERIORITY||Least Squares Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-0.8|-0.5||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.5|-0.8|<0.001
72374262|NCT03595618|144258786|SUPERIORITY||Odds Ratio (OR)|0.95|STANDARD_ERROR_OF_MEAN|0.21||0.992|TWO_SIDED|95.0|0.64|1.43||Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05).|Logistic Model||Two-sided 95% Confidence Interval of the estimate without Dunnett adjustment.|Estimate (Standard Error of log \[estimate\]) of the adjusted odds ratio between GLPG1972 dose regimen and placebo: between the proportions of participants with response: placebo versus GLPG1972 dose regimen.||1.43|0.64|0.992
72374263|NCT03595618|144258786|SUPERIORITY||Odds Ratio (OR)|0.82|STANDARD_ERROR_OF_MEAN|0.21||0.653|TWO_SIDED|95.0|0.55|1.23||Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05).|Logistic Model||Two-sided 95% Confidence Interval of the estimate without Dunnett adjustment.|Estimate (Standard Error of log \[estimate\]) of the adjusted odds ratio between GLPG1972 dose regimen and placebo: between the proportions of participants with response: placebo versus GLPG1972 dose regimen.||1.23|0.55|0.653
72374264|NCT03595618|144258787|SUPERIORITY||Adjusted mean difference|0.03779|STANDARD_ERROR_OF_MEAN|0.02156||0.193|TWO_SIDED|95.0|-0.00448|0.08005||Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05).|Mixed Models Analysis||Two-sided 95% Confidence Interval of the estimate without Dunnett adjustment.|Estimate (Standard Error) of the adjusted difference from baseline to last post baseline value between treatment groups means: placebo minus GLPG1972 dose regimen using a MMRM including the fixed, categorical effects of treatment, region (Asia and Rest of the World), time and treatment-by-time interaction, as well as the continuous, fixed covariates of baseline and time-by-baseline interaction preceded by a Multiple Imputation step for participants without post-baseline measurement.||0.08005|-0.00448|0.193
72374265|NCT03595618|144258787|SUPERIORITY||Adjusted mean difference|0.0358|STANDARD_ERROR_OF_MEAN|0.02235||0.256|TWO_SIDED|95.0|-0.00801|0.07962||Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05).|Mixed Models Analysis||Two-sided 95% Confidence Interval of the estimate without Dunnett adjustment.|Estimate (Standard Error) of the adjusted difference from baseline to last post baseline value between treatment groups means: placebo minus GLPG1972 dose regimen using a MMRM including the fixed, categorical effects of treatment, region (Asia and Rest of the World), time and treatment-by-time interaction, as well as the continuous, fixed covariates of baseline and time-by-baseline interaction preceded by a Multiple Imputation step for participants without post-baseline measurement.||0.07962|-0.00801|0.256
72374266|NCT03595618|144258787|SUPERIORITY||Adjusted mean difference|0.03884|STANDARD_ERROR_OF_MEAN|0.02243||0.201|TWO_SIDED|95.0|-0.00514|0.08281||Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05).|Mixed Models Analysis||Two-sided 95% Confidence Interval of the estimate without Dunnett adjustment.|Estimate (Standard Error) of the adjusted difference from baseline to last post baseline value between treatment groups means: placebo minus GLPG1972 dose regimen using a MMRM including the fixed, categorical effects of treatment, region (Asia and Rest of the World), time and treatment-by-time interaction, as well as the continuous, fixed covariates of baseline and time-by-baseline interaction preceded by a Multiple Imputation step for participants without post-baseline measurement.||0.08281|-0.00514|0.201
72374267|NCT03595618|144258788|SUPERIORITY||Adjusted mean difference|3.12394|STANDARD_ERROR_OF_MEAN|3.13671||0.627|TWO_SIDED|95.0|-3.02464|9.27252||Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05).|ANCOVA||Two-sided 95% Confidence Interval of the estimate without Dunnett adjustment.|Estimate (Standard Error) of the adjusted difference from baseline to last post baseline value between treatment groups means: Placebo minus GLPG1972 dose regimen using an analysis of covariance (ANCOVA) including the factors treatment and region with baseline as covariate and no interaction, after a Multiple Imputation for missing data.||9.27252|-3.02464|0.627
72395056|NCT00720434|144296637|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.46325||||0.1368|TWO_SIDED|95.0|-3.41898|0.49248|||ANCOVA|||An ANCOVA model was used to compare differences among treatments. Independent variables included treatment and log-transformed baseline HCV viral load. Adjusted mean difference and corresponding 95% CI were calculated.||0.49248|-3.41898|0.1368
72395057|NCT00720434|144296637|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.90032||||0.3321|TWO_SIDED|95.0|-2.76711|0.96648|||ANCOVA|||An ANCOVA model was used to compare differences among treatments. Independent variables included treatment and log-transformed baseline HCV viral load. Adjusted mean difference and corresponding 95% CI were calculated.||0.96648|-2.76711|0.3321
72395058|NCT00720434|144296637|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.02865||||0.2839|TWO_SIDED|95.0|-2.95573|0.89844|||ANCOVA|||An ANCOVA model was used to compare differences among treatments. Independent variables included treatment and log-transformed baseline HCV viral load. Adjusted mean difference and corresponding 95% CI were calculated.||0.89844|-2.95573|0.2839
72395059|NCT00720434|144296637|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.12833||||0.8891|TWO_SIDED|95.0|-1.73676|1.99342|||ANCOVA|||An ANCOVA model was used to compare differences among treatments. Independent variables included treatment and log-transformed baseline HCV viral load. Adjusted mean difference and corresponding 95% CI were calculated.||1.99342|-1.73676|0.8891
72395060|NCT00720434|144296638|SUPERIORITY_OR_OTHER||Difference in Proportions|0.6|||||TWO_SIDED|95.0|0.1565|0.8785||||||Week 4: The difference in proportions between treatment groups presented along with 95% CI, were based on exact method for small samples from the binomial distribution.||0.8785|0.1565|
72395061|NCT00720434|144296638|SUPERIORITY_OR_OTHER||Difference in Proportions|0.75|||||TWO_SIDED|95.0|0.233|0.969||||||Week 4: The difference in proportions between treatment groups presented along with 95% CI, were based on exact method for small samples from the binomial distribution.||0.9690|0.2330|
72395062|NCT00720434|144296638|SUPERIORITY_OR_OTHER||Difference in Proportions|0.625|||||TWO_SIDED|95.0|0.0871|0.9191||||||Week 4: The difference in proportions between treatment groups presented along with 95% CI, were based on exact method for small samples from the binomial distribution.||0.9191|0.0871|
72395063|NCT00720434|144296638|SUPERIORITY_OR_OTHER||Difference in Proportions|-0.025|||||TWO_SIDED|95.0|-0.4769|0.4336||||||Week 4: The difference in proportions between treatment groups presented along with 95% CI, were based on exact method for small samples from the binomial distribution.||0.4336|-0.4769|
72374268|NCT03595618|144258788|SUPERIORITY||Adjusted mean difference|0.46842|STANDARD_ERROR_OF_MEAN|3.21111||0.998|TWO_SIDED|95.0|-5.82659|6.76343||Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05).|ANCOVA||Two-sided 95% Confidence Interval of the estimate without Dunnett adjustment.|Estimate (Standard Error) of the adjusted difference from baseline to last post baseline value between treatment groups means: Placebo minus GLPG1972 dose regimen using an ANCOVA including the factors treatment and region with baseline as covariate and no interaction, after a Multiple Imputation for missing data.||6.76343|-5.82659|0.998
72374269|NCT03595618|144258788|SUPERIORITY||Adjusted mean difference|4.11756|STANDARD_ERROR_OF_MEAN|3.2759||0.449|TWO_SIDED|95.0|-2.30536|10.54049||Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05).|ANCOVA||Two-sided 95% Confidence Interval of the estimate without Dunnett adjustment.|Estimate (Standard Error) of the adjusted difference from baseline to last post baseline value between treatment groups means: Placebo minus GLPG1972 dose regimen using an ANCOVA including the factors treatment and region with baseline as covariate and no interaction, after a Multiple Imputation for missing data.||10.54049|-2.30536|0.449
72374270|NCT03595618|144258789|SUPERIORITY||Adjusted mean difference|2.84781|STANDARD_ERROR_OF_MEAN|3.75674||0.789|TWO_SIDED|95.0|-4.51643|10.21205||Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05)|Mixed Models Analysis||Two-sided 95% Confidence Interval of the estimate without Dunnett adjustment.|Estimate (Standard Error) of the adjusted difference from baseline to last post baseline value between treatment groups means: placebo minus GLPG1972 dose regimen using a MMRM including the fixed, categorical effects of treatment, region (Asia and Rest of the World), time and treatment-by-time interaction, as well as the continuous, fixed covariates of baseline and time-by-baseline interaction preceded by a Multiple Imputation step for participants without post-baseline measurement.||10.21205|-4.51643|0.789
72374271|NCT03595618|144258789|SUPERIORITY||Adjusted mean difference|-3.64759|STANDARD_ERROR_OF_MEAN|3.84747||0.661|TWO_SIDED|95.0|-11.19071|3.89553||Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05).|Mixed Models Analysis||Two-sided 95% Confidence Interval of the estimate without Dunnett adjustment.|Estimate (Standard Error) of the adjusted difference from baseline to last post baseline value between treatment groups means: placebo minus GLPG1972 dose regimen using a MMRM including the fixed, categorical effects of treatment, region (Asia and Rest of the World), time and treatment-by-time interaction, as well as the continuous, fixed covariates of baseline and time-by-baseline interaction preceded by a Multiple Imputation step for participants without post-baseline measurement.||3.89553|-11.19071|0.661
72374272|NCT03595618|144258789|SUPERIORITY||Adjusted mean difference|-2.55176|STANDARD_ERROR_OF_MEAN|3.81987||0.843|TWO_SIDED|95.0|-10.04053|4.93701||Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05).|Mixed Models Analysis||Two-sided 95% Confidence Interval of the estimate without Dunnett adjustment.|Estimate (Standard Error) of the adjusted difference from baseline to last post baseline value between treatment groups means: placebo minus GLPG1972 dose regimen using a MMRM including the fixed, categorical effects of treatment, region (Asia and Rest of the World), time and treatment-by-time interaction, as well as the continuous, fixed covariates of baseline and time-by-baseline interaction preceded by a Multiple Imputation step for participants without post-baseline measurement.||4.93701|-10.04053|0.843
72374273|NCT03595618|144258790|SUPERIORITY||Adjusted mean difference|0.0951|STANDARD_ERROR_OF_MEAN|0.0499||0.141|TWO_SIDED|95.0|-0.0028|0.1929||Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05).|ANCOVA||Two-sided 95% Confidence Interval of the estimate without Dunnett adjustment.|Estimate (Standard Error) of the adjusted difference from baseline to last post baseline value between treatment groups means: GLPG1972 dose regimen minus placebo using an ANCOVA including the factors treatment and region with baseline as covariate and no interaction, after a Multiple Imputation for missing data.||0.1929|-0.0028|0.141
72374274|NCT03595618|144258790|SUPERIORITY||Adjusted mean difference|0.0158|STANDARD_ERROR_OF_MEAN|0.0519||0.981|TWO_SIDED|95.0|-0.0861|0.1177||Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05).|ANCOVA||Two-sided 95% Confidence Interval of the estimate without Dunnett adjustment.|Estimate (Standard Error) of the adjusted difference from baseline to last post baseline value between treatment groups means: GLPG1972 dose regimen minus placebo using an ANCOVA including the factors treatment and region with baseline as covariate and no interaction, after a Multiple Imputation for missing data.||0.1177|-0.0861|0.981
72374275|NCT03595618|144258790|SUPERIORITY||Adjusted mean difference|0.0753|STANDARD_ERROR_OF_MEAN|0.0529||0.349|TWO_SIDED|95.0|-0.0286|0.1792||Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05).|ANCOVA||Two-sided 95% Confidence Interval of the estimate without Dunnett adjustment.|Estimate (Standard Error) of the adjusted difference from baseline to last post baseline value between treatment groups means: GLPG1972 dose regimen minus placebo using an ANCOVA including the factors treatment and region with baseline as covariate and no interaction, after a Multiple Imputation for missing data.||0.1792|-0.0286|0.349
72374276|NCT02279407|144258796|SUPERIORITY_OR_OTHER||Geometric mean ratio for difference|0.83||||0.046|TWO_SIDED|95.0|0.7|1.0||Hypotheses tested using Dunnett's multiple testing procedure with a family-wise error rate of 5%, adjusting for 3 pairwise comparisons versus a single control (placebo).|Mixed Models Analysis|||||1.00|0.70|0.046
72493807|NCT02889796|144516580|SUPERIORITY||Difference in Response Rates|9.5|||<|0.001|TWO_SIDED|95.0|5.8|13.1||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg vs Placebo at Week 2||13.1|5.8|<0.001
72493808|NCT02889796|144516580|SUPERIORITY||Difference in Response Rates|4.5||||0.004|TWO_SIDED|95.0|1.4|7.7||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg vs Placebo at Week 2||7.7|1.4|0.004
72374277|NCT02279407|144258797|SUPERIORITY_OR_OTHER||Geometric mean ratio for difference|0.91||||0.502|TWO_SIDED|95.0|0.75|1.11||Conditional upon rejection of at least 1 of the 3 hypotheses for the primary analysis, secondary hypotheses are tested using Tukey's multiple testing procedure with a family-wise error rate of 5%, adjusting for 3 pairwise comparisons.|Mixed Models Analysis|||||1.11|0.75|0.502
72374278|NCT02279407|144258797|SUPERIORITY_OR_OTHER||Geometric mean ratio for difference|0.91||||0.562|TWO_SIDED|95.0|0.73|1.13||Conditional upon rejection of at least 1 of the hypotheses for the primary analysis, secondary hypotheses are tested using Tukey's multiple testing procedure with a family-wise error rate of 5%, adjusting for 3 pairwise comparisons.|Mixed Models Analysis|||||1.13|0.73|0.562
72374279|NCT00864916|144258801|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.34||||0.52|||||||Regression, Linear|||||||0.52
72374280|NCT01816945|144258802|SUPERIORITY|||||||0.15|||||||Fisher Exact|||||||0.15
72374281|NCT01816945|144258805|SUPERIORITY|||||||0.96|||||||t-test, 2 sided|||Two-sample t-test for PHQ-9 at 12 months||||0.96
72374282|NCT01816945|144258806|SUPERIORITY|||||||0.043|||||||t-test, 2 sided|||Two-sample t-test for Social Network Score at 12 month||||0.043
72374283|NCT01087736|144258818|SUPERIORITY_OR_OTHER||Incidence Rate Ratio (IRR)|0.89||||0.019|TWO_SIDED|95.0|0.89|0.98||We tested our Primary hypothesis with a random-intercept repeated subject negative binomial model, modeling week (baseline - week 12) as a continuous variable. All analyses were intent-to-treat and used all observations from all weeks.|negative binomial regression|||Our primary protocol-defined analysis was to examine the within-group efficacy of topiramate to reduce percent drinking days (%DD).||0.98|0.89|0.019
72374284|NCT01087736|144258818|SUPERIORITY_OR_OTHER|||||||0|||||||Other|||There were no pre hoc hypothesis regarding change within placebo group. We were only tested change within the topiramate condition.||||0.00
72374285|NCT01087736|144258818|SUPERIORITY_OR_OTHER||Incidence Rate Ratio (IRR)|0.38||||0.036|TWO_SIDED|95.0|0.15|0.94|||Negative binomial model|||"A secondary analysis was powered to detect a Signal or statistical trend (p\<0.10) for a difference between the topiramate and placebo condition. We compared percent drinking days per week between groups averaged over the active phase of the trial (weeks 1-12). The negative binomial model included fixed effect for week, treatment group, and the interaction between treatment group and week. We covaried for baseline %DD averages to control for prestudy and study enrollment effects."||0.94|0.15|0.036
72374286|NCT01087736|144258819|SUPERIORITY_OR_OTHER||||||<|0.026|||||||Mixed Models Analysis|||We planned to explore the efficacy of topiramate in reducing PTSD symptom severity. We used random-intercept linear mixed models to explore the efficacy for topiramate related reduction in PTSD symptomatology. We looked for an effect of week within TOP. Baseline scores for PTSD symptoms were used as covariates in group comparisons. All analyses were intent-to-treat and used all observations from all weeks.||||<0.026
72374287|NCT01087736|144258819|SUPERIORITY_OR_OTHER|||||||0|||||||Other|||There was not a pre hoc hypothesis regarding change within placebo group. We only examined within group change in the topiramate condition.||||0.00
72374288|NCT02788279|144258851|SUPERIORITY||Hazard Ratio (HR)|1.0||||0.9871|TWO_SIDED|95.0|0.73|1.38|||Stratified Log-Rank|Stratification factors included extended RAS mutation status and time since diagnosis of first metastasis.|Hazard ratio was estimated using stratified Cox regression.|||1.38|0.73|0.9871
72493809|NCT02889796|144516580|SUPERIORITY||Difference in Response Rates|16.2|||<|0.001|TWO_SIDED|95.0|11.3|21.1||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg vs Placebo at Week 4||21.1|11.3|<0.001
72493810|NCT02889796|144516580|SUPERIORITY||Difference in Response Rates|11.2|||<|0.001|TWO_SIDED|95.0|6.5|15.8||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg vs Placebo at Week 4||15.8|6.5|<0.001
72374289|NCT02788279|144258851|SUPERIORITY||Hazard Ratio (HR)|1.19||||0.336|TWO_SIDED|95.0|0.83|1.71|||Stratified Log-Rank|Stratification factors included extended RAS mutation status and time since diagnosis of first metastasis.|Hazard ratio was estimated using stratified Cox regression.|||1.71|0.83|0.3360
72374290|NCT02788279|144258851|SUPERIORITY||Hazard Ratio (HR)|1.01||||0.9686|TWO_SIDED|95.0|0.74|1.38|||Unstratified Log-Rank||Hazard ratio was estimated using unstratified Cox regression.|||1.38|0.74|0.9686
72374291|NCT02788279|144258851|SUPERIORITY||Hazard Ratio (HR)|1.18||||0.3553|TWO_SIDED|95.0|0.83|1.69|||Unstratified Log-Rank||Hazard ratio was estimated using unstratified Cox regression.|||1.69|0.83|0.3553
72374292|NCT02788279|144258852|SUPERIORITY||Hazard Ratio (HR)|1.25||||0.1208|TWO_SIDED|95.0|0.94|1.65|||Stratified Log-Rank|Stratification factors included extended RAS mutation status and time since diagnosis of first metastasis.|Hazard ratio was estimated using stratified Cox regression.|||1.65|0.94|0.1208
72433520|NCT04888585|144380255|SUPERIORITY||Least Squares (LS) Mean Difference|-4.56||||0.014|TWO_SIDED|95.0|-8.21|-0.92|||Mixed Models Analysis|MMRM model includes treatment, visit, treatment-by-visit interaction, stratification factors, and the baseline measurement as covariates.|Response Rate Difference = ABBV-154 40mg EOW - Placebo|||-0.92|-8.21|0.014
72433521|NCT04888585|144380255|SUPERIORITY||Least Squares (LS) Mean Difference|-8.01|||<|0.001|TWO_SIDED|95.0|-11.7|-4.31|||Mixed Models Analysis|MMRM model includes treatment, visit, treatment-by-visit interaction, stratification factors, and the baseline measurement as covariates.|Response Rate Difference = ABBV-154 150mg EOW - Placebo|||-4.31|-11.70|<0.001
72374293|NCT02788279|144258852|SUPERIORITY||Hazard Ratio (HR)|1.39||||0.0509|TWO_SIDED|95.0|1.0|1.94|||Stratified Log-Rank|Stratification factors included extended RAS mutation status and time since diagnosis of first metastasis.|Hazard ratio was estimated using stratified Cox regression.|||1.94|1.00|0.0509
72374294|NCT02788279|144258852|SUPERIORITY||Hazard Ratio (HR)|1.21||||0.1726|TWO_SIDED|95.0|0.92|1.6|||Unstratified Log-Rank||Hazard ratio was estimated using unstratified Cox regression.|||1.60|0.92|0.1726
72374295|NCT02788279|144258852|SUPERIORITY||Hazard Ratio (HR)|1.39||||0.0467|TWO_SIDED|95.0|1.0|1.91|||Unstratified Log-Rank||Hazard ratio was estimated using unstratified Cox regression.|||1.91|1.00|0.0467
72374296|NCT02788279|144258853|SUPERIORITY||Difference in Response Rates|0.51||||1|TWO_SIDED|95.0|-3.92|4.94|||Stratified Cochrane-Mantel-Haenszel|Stratification factors included extended RAS mutation status and time since diagnosis of first metastasis.|95% CI for difference in response rates was constructed using Hauck-Anderson method.|||4.94|-3.92|1.0000
72374297|NCT02788279|144258853|SUPERIORITY||Difference in Response Rates|0.0||||1|TWO_SIDED|95.0|-4.89|4.89|||Stratified Cochran-Mantel-Haenszel|Stratification factors included extended RAS mutation status and time since diagnosis of first metastasis.|95% CI for difference in response rates was constructed using Hauck-Anderson method.|||4.89|-4.89|1.0000
72374298|NCT03996369|144258861|SUPERIORITY||Risk Difference (RD)|9.69|||=|0.026|TWO_SIDED|95.0|1.14|18.23|||Cochran-Mantel-Haenszel|||Week 12||18.23|1.14|=0.026
72374299|NCT03996369|144258862|SUPERIORITY||Risk Difference (RD)|12.11|||=|0.009|TWO_SIDED|95.0|3.0|21.23|||Cochran-Mantel-Haenszel|||Week 12||21.23|3.00|=0.009
72374300|NCT03996369|144258863|SUPERIORITY||Risk Difference (RD)|17.48|||=|0.001|TWO_SIDED|95.0|6.81|28.15|||Cochran-Mantel-Haenszel|||Week 12||28.15|6.81|=0.001
72374301|NCT03996369|144258864|SUPERIORITY||Risk Difference (RD)|7.44|||=|0.036|TWO_SIDED|95.0|0.5|14.39|||Cochran-Mantel-Haenszel|||Week 12||14.39|0.50|=0.036
72374302|NCT03996369|144258865|SUPERIORITY||Risk Difference (RD)|21.23|||<|0.001|TWO_SIDED|95.0|10.18|32.29|||Cochran-Mantel-Haenszel|||Week 12||32.29|10.18|<0.001
72374303|NCT03996369|144258866|SUPERIORITY||Risk Difference (RD)|9.24|||=|0.009|TWO_SIDED|95.0|2.27|16.2|||Cochran-Mantel-Haenszel|||Week 12||16.20|2.27|=0.009
72374304|NCT03996369|144258867|SUPERIORITY||Risk Difference (RD)|5.85|||=|0.115|TWO_SIDED|95.0|-1.42|13.13|||Cochran-Mantel-Haenszel|||Week 2||13.13|-1.42|=0.115
72374305|NCT03996369|144258867|SUPERIORITY||Risk Difference (RD)|11.83|||=|0.007|TWO_SIDED|95.0|3.19|20.47|||Cochran-Mantel-Haenszel|||Week 4||20.47|3.19|=0.007
72374306|NCT03996369|144258867|SUPERIORITY||Risk Difference (RD)|14.84|||=|0.003|TWO_SIDED|95.0|4.98|24.69|||Cochran-Mantel-Haenszel|||Week 8||24.69|4.98|=0.003
72374307|NCT03996369|144258868|SUPERIORITY||Risk Difference (RD)|2.83|||=|0.128|TWO_SIDED|95.0|-0.81|6.48|||Cochran-Mantel-Haenszel|||Week 2||6.48|-0.81|=0.128
72374308|NCT03996369|144258868|SUPERIORITY||Risk Difference (RD)|8.32|||=|0.002|TWO_SIDED|95.0|3.01|13.64|||Cochran-Mantel-Haenszel|||Week 4||13.64|3.01|=0.002
72374309|NCT03996369|144258868|SUPERIORITY||Risk Difference (RD)|7.06|||=|0.032|TWO_SIDED|95.0|0.62|13.49|||Cochran-Mantel-Haenszel|||Week 8||13.49|0.62|=0.032
72374310|NCT03996369|144258868|SUPERIORITY||Risk Difference (RD)|9.18|||=|0.014|TWO_SIDED|95.0|1.82|16.54|||Cochran-Mantel-Haenszel|||Week 12||16.54|1.82|=0.014
72374311|NCT03996369|144258869|SUPERIORITY||Risk Difference (RD)|15.55|||=|0.002|TWO_SIDED|95.0|5.65|25.46|||Cochran-Mantel-Haenszel|||Week 2||25.46|5.65|=0.002
72374312|NCT03996369|144258869|SUPERIORITY||Risk Difference (RD)|14.98|||=|0.007|TWO_SIDED|95.0|4.05|25.91|||Cochran-Mantel-Haenszel|||Week 4||25.91|4.05|=0.007
72374313|NCT03996369|144258869|SUPERIORITY||Risk Difference (RD)|22.6|||<|0.001|TWO_SIDED|95.0|11.95|33.25|||Cochran-Mantel-Haenszel|||Week 8||33.25|11.95|<0.001
72374314|NCT03996369|144258869|SUPERIORITY||Risk Difference (RD)|17.58|||=|0.002|TWO_SIDED|95.0|6.7|28.47|||Cochran-Mantel-Haenszel|||Week 12||28.47|6.70|=0.002
72374315|NCT03996369|144258870|SUPERIORITY||Risk Difference (RD)|15.99|||=|0.002|TWO_SIDED|95.0|6.07|25.91|||Cochran-Mantel-Haenszel|||Week 2||25.91|6.07|=0.002
72374316|NCT03996369|144258870|SUPERIORITY||Risk Difference (RD)|15.45|||=|0.006|TWO_SIDED|95.0|4.54|26.36|||Cochran-Mantel-Haenszel|||Week 4||26.36|4.54|=0.006
72374317|NCT03996369|144258870|SUPERIORITY||Risk Difference (RD)|22.14|||<|0.001|TWO_SIDED|95.0|11.43|32.85|||Cochran-Mantel-Haenszel|||Week 8||32.85|11.43|<0.001
72555609|NCT03100344|144642385|SUPERIORITY||mean difference of percentage changes|-37.3|||<|0.001|TWO_SIDED|95.0|-47.4|-27.2|||Kenward Roger|||Week 8||-27.2|-47.4|<0.001
72374318|NCT03996369|144258870|SUPERIORITY||Risk Difference (RD)|18.49|||<|0.001|TWO_SIDED|95.0|7.65|29.33|||Cochran-Mantel-Haenszel|||Week 12||29.33|7.65|<0.001
72374319|NCT02184572|144258897|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The upper limit of the 2-sided standardised asymptotic 95% Confidence Interval (CI) for the group difference (INV\_MMR minus COM\_MMR) in incidence of fever ≥ 39.0°C (≥ 102.2°F) should be equal to or below 5%.|Difference in incidence of fever|1.11|||||TWO_SIDED|95.0|-0.93|2.89||||||Difference between groups (INV\_MMR Group minus COM\_MMR Group) in incidence of fever \> 39.0°C.||2.89|-0.93|
72374320|NCT02184572|144258897|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The upper limit of the 2-sided standardised asymptotic 95% CI for the group difference (INV\_MMR minus COM\_MMR) in incidence of fever ≥ 38.0°C (≥ 100.4°F) should be equal to or below 10%.|Difference in incidence of fever|1.09|||||TWO_SIDED|95.0|-2.89|4.85||||||Difference between groups (INV\_MMR Group minus COM\_MMR Group) in incidence of fever \> 38.0°C.||4.85|-2.89|
72374321|NCT01185353|144258941|SUPERIORITY_OR_OTHER||||||<|0.001||||||A priori p-value significance threshold: 1-sided ≤0.10|Regression, Logistic|||||||<0.001
72374322|NCT01185353|144258943|SUPERIORITY_OR_OTHER|||||||0.045|TWO_SIDED|||||P-value is for Week 12. A priori p-value significance threshold: 1-sided ≤0.10.|Fisher Exact|||||||0.045
72374323|NCT01185353|144258943|SUPERIORITY_OR_OTHER|||||||0.088|TWO_SIDED|||||P-value is for Week 12. A priori p-value significance threshold: 1-sided ≤0.10.|Fisher Exact|||||||0.088
72374324|NCT01185353|144258943|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||P-value is for Week 12. A priori p-value significance threshold: 1-sided ≤0.10.|Fisher Exact|||||||<0.001
72374325|NCT01185353|144258943|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||P-value is for Week 12. A priori p-value significance threshold: 1-sided ≤0.10.|Fisher Exact|||||||<0.001
72374326|NCT01185353|144258945|SUPERIORITY_OR_OTHER|||||||0.003|TWO_SIDED|||||P-value is for Week 12. A priori p-value significance threshold: 1-sided ≤0.10.|Fisher Exact|||||||0.003
72374327|NCT01185353|144258945|SUPERIORITY_OR_OTHER|||||||0.162|TWO_SIDED|||||P-value is for Week 12. A priori p-value significance threshold: 1-sided ≤0.10.|Fisher Exact|||||||0.162
72374328|NCT01185353|144258945|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||P-value is for Week 12. A priori p-value significance threshold: 1-sided ≤0.10.|Fisher Exact|||||||<0.001
72374329|NCT01185353|144258945|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||P-value is for Week 12. A priori p-value significance threshold: 1-sided ≤0.10.|Fisher Exact|||||||<0.001
72374330|NCT01185353|144258947|SUPERIORITY_OR_OTHER|||||||0.017|TWO_SIDED|||||P-value is for Week 12. A priori p-value significance threshold: 1-sided ≤0.10.|Fisher Exact|||||||0.017
72374331|NCT01185353|144258947|SUPERIORITY_OR_OTHER|||||||0.109|TWO_SIDED|||||P-value is for Week 12. A priori p-value significance threshold: 1-sided ≤0.10.|Fisher Exact|||||||0.109
72374332|NCT01185353|144258947|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||P-value is for Week 12. A priori p-value significance threshold: 1-sided ≤0.10.|Fisher Exact|||||||<0.001
72374333|NCT01185353|144258947|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||P-value is for Week 12. A priori p-value significance threshold: 1-sided ≤0.10.|Fisher Exact|||||||<0.001
72374334|NCT01185353|144258951|SUPERIORITY_OR_OTHER|||||||0.48|TWO_SIDED|||||P-value is for TJC - Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||0.480
72374335|NCT01185353|144258951|SUPERIORITY_OR_OTHER|||||||0.064|TWO_SIDED|||||P-value is for TJC - Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||0.064
72555610|NCT03100344|144642385|SUPERIORITY||mean difference of percentage changes|-34.1|||<|0.001|TWO_SIDED|95.0|-44.4|-23.8|||Kenward Roger|||Week 8||-23.8|-44.4|<0.001
72555611|NCT03100344|144642385|SUPERIORITY||mean difference of percentage changes|-24.1|||<|0.001|TWO_SIDED|95.0|-35.6|-12.5|||Kenward Roger|||Week 12||-12.5|-35.6|<0.001
72374336|NCT01185353|144258951|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||P-value is for TJC - Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||<0.001
72374337|NCT01185353|144258951|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED|||||P-value is for TJC - Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||0.001
72374338|NCT01185353|144258951|SUPERIORITY_OR_OTHER|||||||0.116|TWO_SIDED|||||P-value is for SJC - Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||0.116
72374339|NCT01185353|144258951|SUPERIORITY_OR_OTHER|||||||0.201|TWO_SIDED|||||P-value is for SJC - Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||0.201
72374340|NCT01185353|144258951|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||P-value is for SJC - Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||<0.001
72374341|NCT01185353|144258951|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED|||||P-value is for SJC - Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||0.002
72374342|NCT01185353|144258953|SUPERIORITY_OR_OTHER|||||||0.003|TWO_SIDED|||||P-value is for Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||0.003
72555612|NCT03100344|144642385|SUPERIORITY||mean difference of percentage changes|-38.4|||<|0.001|TWO_SIDED|95.0|-49.7|-27.2|||Kenward Roger|||Week 12||-27.2|-49.7|<0.001
72374343|NCT01185353|144258953|SUPERIORITY_OR_OTHER|||||||0.167|TWO_SIDED|||||P-value is for Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||0.167
72374344|NCT01185353|144258953|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||P-value is for Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||<0.001
72374345|NCT01185353|144258953|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED|||||P-value is for Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||0.001
72374346|NCT01185353|144258955|SUPERIORITY_OR_OTHER|||||||0.016|TWO_SIDED|||||P-value is for Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||0.016
72374347|NCT01185353|144258955|SUPERIORITY_OR_OTHER|||||||0.108|TWO_SIDED|||||P-value is for Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||0.108
72374348|NCT01185353|144258955|SUPERIORITY_OR_OTHER|||||||0.008|TWO_SIDED|||||P-value is for Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||0.008
72374349|NCT01185353|144258955|SUPERIORITY_OR_OTHER|||||||0.368|TWO_SIDED|||||P-value is for Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||0.368
72374350|NCT01185353|144258957|SUPERIORITY_OR_OTHER|||||||0.039|TWO_SIDED|||||P-value is for Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||0.039
72374351|NCT01185353|144258957|SUPERIORITY_OR_OTHER|||||||0.458|TWO_SIDED|||||P-value is for Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||0.458
72374352|NCT01185353|144258957|SUPERIORITY_OR_OTHER|||||||0.008|TWO_SIDED|||||P-value is for Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||0.008
72374353|NCT01185353|144258957|SUPERIORITY_OR_OTHER|||||||0.029|TWO_SIDED|||||P-value is for Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||0.029
72374354|NCT01185353|144258959|SUPERIORITY_OR_OTHER|||||||0.217|TWO_SIDED|||||P-value is for Physician's Assessment of DA - Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||0.217
72433522|NCT04888585|144380255|SUPERIORITY||Least Squares (LS) Mean Difference|-11.41|||<|0.001|TWO_SIDED|95.0|-15.1|-7.73|||Mixed Models Analysis|MMRM model includes treatment, visit, treatment-by-visit interaction, stratification factors, and the baseline measurement as covariates.|Response Rate Difference = ABBV-154 340mg EOW - Placebo|||-7.73|-15.10|<0.001
72433523|NCT04888585|144380255|SUPERIORITY||Least Squares (LS) Mean Difference|-5.29||||0.004|TWO_SIDED|95.0|-8.89|-1.69|||Mixed Models Analysis|MMRM model includes treatment, visit, treatment-by-visit interaction, stratification factors, and the baseline measurement as covariates.|Response Rate Difference = ABBV-154 340mg E4W - Placebo|||-1.69|-8.89|0.004
72433524|NCT04888585|144380256|SUPERIORITY||Response Rate Difference|24.7|||<|0.001|TWO_SIDED|95.0|12.1|37.3|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted for the stratification factors.|Response Rate Difference = ABBV-154 40mg EOW - Placebo|||37.3|12.1|<0.001
72555613|NCT03100344|144642385|SUPERIORITY||mean difference of percentage changes|-30.2|||<|0.001|TWO_SIDED|95.0|-41.7|-18.7|||Kenward Roger|||Week 12||-18.7|-41.7|<0.001
72555614|NCT03100344|144642385|SUPERIORITY||mean difference of percentage changes|-20.9|||<|0.001|TWO_SIDED|95.0|-32.8|-8.9|||Kenward Roger|||Week 16||-8.9|-32.8|<0.001
72555615|NCT03100344|144642385|SUPERIORITY||mean difference of percentage changes|-34.3|||<|0.001|TWO_SIDED|95.0|-46.0|-22.6|||Kenward Roger|||Week 16||-22.6|-46.0|<0.001
72374355|NCT01185353|144258959|SUPERIORITY_OR_OTHER|||||||0.092|TWO_SIDED|||||P-value is for Physician's Assessment of DA - Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||0.092
72374356|NCT01185353|144258959|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||P-value is for Physician's Assessment of DA - Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||<0.001
72374357|NCT01185353|144258959|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||P-value is for Physician's Assessment of DA - Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||<0.001
72374358|NCT01185353|144258959|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||P-value is for Patient's Assessment of DA - Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||<0.001
72374359|NCT01185353|144258959|SUPERIORITY_OR_OTHER|||||||0.072|TWO_SIDED|||||P-value is for Patient's Assessment of DA - Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||0.072
72374360|NCT01185353|144258959|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||P-value is for Patient's Assessment of DA - Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||<0.001
72374361|NCT01185353|144258959|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||P-value is for Patient's Assessment of DA - Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||<0.001
72374362|NCT01185353|144258959|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||P-value is for Patient's Assessment of Pain - Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||<0.001
72374363|NCT01185353|144258959|SUPERIORITY_OR_OTHER|||||||0.082|TWO_SIDED|||||P-value is for Patient's Assessment of Pain - Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||0.082
72374364|NCT01185353|144258959|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||P-value is for Patient's Assessment of Pain - Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||<0.001
72374365|NCT01185353|144258959|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||P-value is for Patient's Assessment of Pain - Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||<0.001
72374366|NCT01185353|144258961|SUPERIORITY_OR_OTHER|||||||0.024|TWO_SIDED|||||P-value is for Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||0.024
72374367|NCT01185353|144258961|SUPERIORITY_OR_OTHER|||||||0.03|TWO_SIDED|||||P-value is for Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||0.030
72374368|NCT01185353|144258961|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||P-value is for Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||<0.001
72374369|NCT01185353|144258961|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||P-value is for Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||<0.001
72374370|NCT01185353|144258963|SUPERIORITY_OR_OTHER|||||||0.12|TWO_SIDED|||||P-value is for comparison of the superiority of the LY3009104 dose level vs. placebo for the ordinal levels of response - Week 12. A priori p-value significance threshold: 1-sided ≤0.10.|Cochran-Mantel-Haenszel|||||||0.120
72374371|NCT01185353|144258963|SUPERIORITY_OR_OTHER|||||||0.012|TWO_SIDED|||||P-value is for comparison of the superiority of the LY3009104 dose level vs. placebo for the ordinal levels of response - Week 12. A priori p-value significance threshold: 1-sided ≤0.10.|Cochran-Mantel-Haenszel|||||||0.012
72374372|NCT01185353|144258963|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||P-value is for comparison of the superiority of the LY3009104 dose level vs. placebo for the ordinal levels of response - Week 12. A priori p-value significance threshold: 1-sided ≤0.10.|Cochran-Mantel-Haenszel|||||||<0.001
72374373|NCT01185353|144258963|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||P-value is for comparison of the superiority of the LY3009104 dose level vs. placebo for the ordinal levels of response - Week 12. A priori p-value significance threshold: 1-sided ≤0.10.|Cochran-Mantel-Haenszel|||||||<0.001
72374374|NCT01185353|144258965|SUPERIORITY_OR_OTHER|||||||0.409|TWO_SIDED|||||P-value is for Low Disease Activity - Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|Fisher Exact|||||||0.409
72374375|NCT01185353|144258965|SUPERIORITY_OR_OTHER|||||||0.371|TWO_SIDED|||||P-value is for Low Disease Activity - Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|Fisher Exact|||||||0.371
72374376|NCT01185353|144258965|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||P-value is for Low Disease Activity - Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|Fisher Exact|||||||<0.001
72493811|NCT02889796|144516580|SUPERIORITY||Difference in Response Rates|26.9|||<|0.001|TWO_SIDED|95.0|20.6|33.3||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg vs Placebo at Week 24||33.3|20.6|<0.001
72493812|NCT02889796|144516580|SUPERIORITY||Difference in Response Rates|19.4|||<|0.001|TWO_SIDED|95.0|13.1|25.8||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg vs Placebo at Week 24||25.8|13.1|<0.001
72493813|NCT02889796|144516582|SUPERIORITY||Difference in Response Rates|4.4|||<|0.001|TWO_SIDED|95.0|2.1|6.7||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg vs Placebo at Week 2.||6.7|2.1|<0.001
72374377|NCT01185353|144258965|SUPERIORITY_OR_OTHER|||||||0.007|TWO_SIDED|||||P-value is for Low Disease Activity - Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|Fisher Exact|||||||0.007
72374378|NCT01185353|144258965|SUPERIORITY_OR_OTHER|||||||0.033|TWO_SIDED|||||P-value is for Remission - Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|Fisher Exact|||||||0.033
72374379|NCT01185353|144258965|SUPERIORITY_OR_OTHER|||||||0.019|TWO_SIDED|||||P-value is for Remission - Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|Fisher Exact|||||||0.019
72374380|NCT01185353|144258965|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||P-value is for Remission - Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|Fisher Exact|||||||<0.001
72374381|NCT01185353|144258965|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED|||||P-value is for Remission - Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|Fisher Exact|||||||0.001
72374382|NCT01185353|144258967|SUPERIORITY_OR_OTHER|||||||0.015|TWO_SIDED|||||P-value is for Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||0.015
72374383|NCT01185353|144258967|SUPERIORITY_OR_OTHER|||||||0.073|TWO_SIDED|||||P-value is for Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||0.073
72374384|NCT01185353|144258967|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||P-value is for Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||<0.001
72374385|NCT01185353|144258967|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||P-value is for Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||<0.001
72374386|NCT01185353|144258968|SUPERIORITY_OR_OTHER|||||||0.021|TWO_SIDED|||||P-value is for PCS. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||0.021
72374387|NCT01185353|144258968|SUPERIORITY_OR_OTHER|||||||0.194|TWO_SIDED|||||P-value is for PCS. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||0.194
72374388|NCT01185353|144258968|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||P-value is for PCS. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||<0.001
72374389|NCT01185353|144258968|SUPERIORITY_OR_OTHER|||||||0.012|TWO_SIDED|||||P-value is for PCS. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||0.012
72374390|NCT01185353|144258968|SUPERIORITY_OR_OTHER|||||||0.449|TWO_SIDED|||||P-value is for MCS. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||0.449
72374391|NCT01185353|144258968|SUPERIORITY_OR_OTHER|||||||0.578|TWO_SIDED|||||P-value is for MCS. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||0.578
72374392|NCT01185353|144258968|SUPERIORITY_OR_OTHER|||||||0.14|TWO_SIDED|||||P-value is for MCS. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||0.140
72374393|NCT01185353|144258968|SUPERIORITY_OR_OTHER|||||||0.266|TWO_SIDED|||||P-value is for MCS. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||0.266
72374394|NCT01185353|144258969|SUPERIORITY_OR_OTHER|||||||0.005|TWO_SIDED||||||ANCOVA|A priori p-value significance threshold: 2-sided ≤0.10.||||||0.005
72374395|NCT01185353|144258969|SUPERIORITY_OR_OTHER|||||||0.135|TWO_SIDED|||||A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||0.135
72374396|NCT01185353|144258969|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||<0.001
72374397|NCT01185353|144258969|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED|||||A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||0.001
72374398|NCT01185353|144258970|SUPERIORITY_OR_OTHER|||||||0.203|TWO_SIDED|||||A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||0.203
72374399|NCT01185353|144258970|SUPERIORITY_OR_OTHER|||||||0.164|TWO_SIDED|||||A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||0.164
72374400|NCT01185353|144258970|SUPERIORITY_OR_OTHER|||||||0.018|TWO_SIDED|||||A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||0.018
72374401|NCT01185353|144258970|SUPERIORITY_OR_OTHER|||||||0.097|TWO_SIDED|||||A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||0.097
72374402|NCT01227629|144258997|SUPERIORITY_OR_OTHER|||||||0.0357||95.0|||||Kruskal-Wallis|||Group comparison of differences from baseline to last available value||||0.0357
72374403|NCT01227629|144258998|SUPERIORITY_OR_OTHER|||||||0.26711||95.0|||||Kruskal-Wallis|||Group comparison of differences from baseline to week 12||||0.26711
72374404|NCT00362180|144259015|SUPERIORITY_OR_OTHER|||||||0.7244|TWO_SIDED||||||exact Wilcoxon Rank-sum test|||The p-value is a comparison between the placebo group and the mipomersen group in Cohort E as a change from Baseline to Day 26.||||0.7244
72374405|NCT00362180|144259015|SUPERIORITY_OR_OTHER|||||||0.0513|TWO_SIDED||||||exact Wilcoxon Rank-sum test|||The p-value is a comparison between the placebo group and the mipomersen group in Cohort E as a change from Baseline to Day 99.||||0.0513
72374406|NCT02558829|144259099|OTHER|Positive percent agreement \[%\] = 100% x A/(A+C). A= MAC outcome positive and ITT outcome positive; C = MAC outcome negative and ITT positive|CI (Clopper Pearson): positive agreement|74.32|||||TWO_SIDED|95.0|62.84|83.78||||||The estimated percentages of the agreements and the two-sided 95% confidence interval (or one-sided 97.5% confidence interval) of the percent agreement based on Clopper-Pearson are presented. The performance of the MAC (cut-off point 2.8 ng/mL) was considered to be acceptable if the lower bound of the two-sided 95% CI (or lower bound of the one-sided 97.5% CI) was 75% or higher for 'percent negative agreement', and 70% or higher for the 'percent positive agreement'.||83.78|62.84|
72374407|NCT02558829|144259099|OTHER|Negative percent agreement \[%\] = 100% x D/(B+D). D = MAC outcome negative and ITT outcome negative; B = MAC outcome positive and ITT outcome negative|CI (Clopper Pearson): negative agreement|93.94|||||TWO_SIDED|95.0|85.2|98.32||||||Please refer to Statistical Analysis 1.||98.32|85.20|
72374408|NCT02558829|144259100|OTHER|The secondary diagnostic accuracy measure was 'percent overall agreement'.|overall agreement|83.57|||||TWO_SIDED|95.0|76.38|89.29||||||This variable was analyzed using the same methodology described for the analyses for the primary efficacy variables. in the below, the results for Step 1 (peak GH level among all post baseline samples) are presented.||89.29|76.38|
72374409|NCT02558829|144259102|OTHER||Mean Difference (Final Values)|-2.9|STANDARD_DEVIATION|6.38|||TWO_SIDED|||||||||"Pre/post dose comparison of ECGs was done for both GHSTs. During the GHSTs, ECGs were measured at pre-dose (up to 15 min before) and 60 minutes post-dose. Furthermore, ECGs were measured at screening and at End-of-Study (EOS) Visit.~Calculations were done from two time points: baseline and 60 min post-dose. Baseline is either the screening or pre-dose value."||||
72374410|NCT02558829|144259102|OTHER|Please refer to Statistical Analysis 1 for this secondary outcome measure.|Mean Difference (Final Values)|1.8|STANDARD_DEVIATION|8.15|||TWO_SIDED|||||||||||||
72374411|NCT02558829|144259103|OTHER|Sensitivity is the probability that the test result is positive given the subject has the disease (for the purpose of this analysis, all group A subjects were assumed to have AGHD, but none of the group D subjects). Sensitivity (SS) was estimated by: SS = TP/(TP+FN). TP=True AGHD positive subject; FN=False AGHD negative subject.|CI (Clopper Pearson)|0.87|||||TWO_SIDED|95.0|0.72|0.96||||||Sensitivity was estimated for the MAC at the pre-defined cut-off point GH: 2.8 ng/mL.||0.96|0.72|
72374412|NCT02558829|144259103|OTHER|"Specificity is the probability that the test result is negative given the subject does not have the disease.~Specificity (SP) was estimated by: SP = TN/(TN+FP). TN = True AGHD negative Subjects; FP = False AGHD positive subjects."|CI (Clopper Pearson)|0.96|||||TWO_SIDED|95.0|0.8|1.0||||||Specificity was estimated for the MAC at the pre-defined cut-off point GH: 2.8 ng/mL.||1.00|0.80|
72374413|NCT02558829|144259104|OTHER|Positive percent agreement \[%\] = 100% x A/(A+C). A= test outcome positive for MAC core study part and positive for MAC repeatability extension; C = test outcome positive for MAC core study part and negative for MAC repeatability extension.|CI (Clopper Pearson): positive agreement|88.89|||||TWO_SIDED|95.0|65.29|98.62||||||Please refer to Statistical Analysis 1 for this outcome.||98.62|65.29|
72433525|NCT04888585|144380256|SUPERIORITY||Response Rate Difference|30.2|||<|0.001|TWO_SIDED|95.0|17.4|42.9|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted for the stratification factors.|Response Rate Difference = ABBV-154 150mg EOW - Placebo|||42.9|17.4|<0.001
72433526|NCT04888585|144380256|SUPERIORITY||Response Rate Difference|45.4|||<|0.001|TWO_SIDED|95.0|33.5|57.4|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted for the stratification factors.|Response Rate Difference = ABBV-154 340mg EOW - Placebo|||57.4|33.5|<0.001
72433527|NCT04888585|144380256|SUPERIORITY||Response Rate Difference|24.6|||<|0.001|TWO_SIDED|95.0|11.9|37.3|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted for the stratification factors|Response Rate Difference = ABBV-154 340mg E4W - Placebo|||37.3|11.9|<0.001
72433528|NCT04888585|144380257|SUPERIORITY||Response Rate Difference|6.5||||0.031|TWO_SIDED|95.0|0.6|12.4|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted for the stratification factors.|Response Rate Difference = ABBV-154 40mg EOW - Placebo|||12.4|0.6|0.031
72433529|NCT04888585|144380257|SUPERIORITY||Response Rate Difference|9.8||||0.007|TWO_SIDED|95.0|2.7|17.0|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted for the stratification factors.|Response Rate Difference = ABBV-154 150mg EOW - Placebo|||17.0|2.7|0.007
72433530|NCT04888585|144380257|SUPERIORITY||Response Rate Difference|10.9||||0.004|TWO_SIDED|95.0|3.6|18.2|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted for the stratification factors.|Response Rate Difference = ABBV-154 340mg EOW - Placebo|||18.2|3.6|0.004
72433531|NCT04888585|144380257|SUPERIORITY||Response Rate Difference|0.9||||0.709|TWO_SIDED|95.0|-4.0|5.9|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted for the stratification factors.|Response Rate Difference = ABBV-154 340mg E4W - Placebo|||5.9|-4.0|0.709
72433532|NCT04888585|144380258|SUPERIORITY||Response Rate Difference|16.9||||0.006|TWO_SIDED|95.0|4.9|28.9|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted for the stratification factors.|Response Rate Difference = ABBV-154 40mg EOW - Placebo|||28.9|4.9|0.006
72374414|NCT02558829|144259104|OTHER|Negative percent agreement \[%\] = 100% x D/(B+D). D = test outcome negative for MAC core study part and negative for MAC repeatability extension; B = test outcome negative for MAC core study part and positive for MAC repeatability extension|CI (Clopper Pearson): negative agreement|100.0|||||TWO_SIDED|95.0|79.41|100.0||||||Amendment no 1 had been issued for selected sites in Europe to obtain exploratory data on the repeatability of the MAC in a subset of subjects that had completed the core study.||100.00|79.41|
72374415|NCT00097981|144259105|SUPERIORITY_OR_OTHER|||||||0.49|||||||Cochran-Mantel-Haenszel|Stratified by International Prognostic Index (IPI) stage 1,2 and 3||||||0.49
72374416|NCT00097981|144259106|SUPERIORITY_OR_OTHER|||||||0.42|||||||Cochran-Mantel-Haenszel|Stratified by International Prognostic Index (IPI) stage 1,2 and 3||||||0.42
72374417|NCT00097981|144259107|SUPERIORITY_OR_OTHER|||||||0.42||95.0|||||Log Rank|||||||0.42
72374418|NCT00097981|144259108|SUPERIORITY_OR_OTHER|||||||0.5162||95.0|||||Log Rank|||||||0.5162
72374419|NCT00097981|144259109|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.975||||0.93|TWO_SIDED|95.0|0.529|1.797|||Log Rank|Stratified log-rank test||||1.797|0.529|0.93
72374420|NCT00538785|144259115|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.746|||||TWO_SIDED|95.0|0.344|1.586|||Guess method|Exact conditional binomial method conditioning on the total number of cases with mid-probability adjustment||Relative risk and confidence interval adjusted for the stratification factor of CHD stratum (cyanotic or other) specified on the CRF||1.586|0.344|
72374421|NCT00538785|144259116|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.495|||||TWO_SIDED|95.0|0.101|1.989|||Guess method|Exact conditional binomial method conditioning on the total number of cases with mid-probability adjustment||Relative risk and confidence interval adjusted for the stratification factor of CHD stratum (cyanotic or other) specified on the CRF||1.989|0.101|
72374422|NCT00791973|144259134|SUPERIORITY_OR_OTHER|||||||0.33|||||||Wilcoxon signed-rank test|||||||0.33
72374423|NCT00791973|144259135|SUPERIORITY_OR_OTHER|||||||0.14|||||||Wilcoxon signed-rank test|||||||0.14
72374424|NCT01101308|144259167|NON_INFERIORITY_OR_EQUIVALENCE|A mixed-model analysis of variance was used to compare (test vs reference) and the 90% confidence intervals were estimated for the ratios (test/reference).|Geometric Test/Ref Ratio x 100|102.0|||||TWO_SIDED|90.0|97.51|107.27|||ANOVA||Bioequivalence is established when 90% Confidence Interval falls within 80%-125%.|||107.27|97.51|
72374425|NCT01101308|144259168|NON_INFERIORITY_OR_EQUIVALENCE|A mixed-model analysis of variance was used to compare (test vs reference) and the 90% confidence intervals were estimated for the ratios (test/reference)|Geometric Test/Ref Ratio x 100|100.0|||||TWO_SIDED|90.0|97.19|103.0|||ANOVA||Bioequivalence is established when 90% Confidence Interval falls within 80%-125%.|||103.00|97.19|
72374426|NCT01101308|144259169|NON_INFERIORITY_OR_EQUIVALENCE|A mixed-model analysis of variance was used to compare (test vs reference) and the 90% confidence intervals were estimated for the ratios (test/reference)|Geometric Test/Ref Ratio x 100|100.0|||||TWO_SIDED|90.0|97.14|102.99|||ANOVA||Bioequivalence is established when 90% Confidence Interval falls within 80%-125%.|||102.99|97.14|
72374427|NCT02614469|144259175|SUPERIORITY_OR_OTHER||Ratio of Geometric Means|103.0|||||TWO_SIDED|90.0|98.0|108.0|||||Fed/Fasting Ratio|To assess the effect of food on the PK of urate, analyses of variance (ANOVA) using a linear mixed-effects model was fitted to the natural logarithmic transformation of PK parameters of urate. The linear mixed-effects model will include subject as a random effect, and treatment, period, and sequence as fixed effects. The 90% confidence intervals were constructed for the ratio of geometric means of PK parameters between fed and fasted treatments, based on log-transformed data.||108|98.0|
72374428|NCT02614469|144259176|SUPERIORITY_OR_OTHER||Ratio of Geometric Means|99.3|||||TWO_SIDED|90.0|96.9|102.0|||||Fed/Fasted Ratio|To assess the effect of food on the PK of urate, analyses of variance (ANOVA) using a linear mixed-effects model was fitted to the natural logarithmic transformation of PK parameters of urate. The linear mixed-effects model will include subject as a random effect, and treatment, period, and sequence as fixed effects. The 90% confidence intervals were constructed for the ratio of geometric means of PK parameters between fed and fasted treatments, based on log-transformed data.||102|96.9|
72374429|NCT02614469|144259180|SUPERIORITY_OR_OTHER||Ratio of Geometric Means|103.0|||||TWO_SIDED|90.0|90.9|118.0|||||Fed/Fasted Ratio|To assess the effect of food on the PK of urate, analyses of variance (ANOVA) using a linear mixed-effects model was fitted to the natural logarithmic transformation of PK parameters of urate. The linear mixed-effects model will include subject as a random effect, and treatment, period, and sequence as fixed effects. The 90% confidence intervals were constructed for the ratio of geometric means of PK parameters between fed and fasted treatments, based on log-transformed data.||118|90.9|
72374430|NCT02614469|144259181|SUPERIORITY_OR_OTHER||Ratio of Geometric Means|83.4|||||TWO_SIDED|90.0|62.1|112.0|||||Fed/Fasted Ratio|To assess the effect of food on the PK of urate, analyses of variance (ANOVA) using a linear mixed-effects model was fitted to the natural logarithmic transformation of PK parameters of urate. The linear mixed-effects model will include subject as a random effect, and treatment, period, and sequence as fixed effects. The 90% confidence intervals were constructed for the ratio of geometric means of PK parameters between fed and fasted treatments, based on log-transformed data.||112|62.1|
72374431|NCT02673541|144259272|OTHER|||||||1|||||||Fisher Exact|||||||1
72374432|NCT01054183|144259281|NON_INFERIORITY_OR_EQUIVALENCE|powered for 62 patients||||||0.57||95.0|||||z test, two-sided|||Null hypothesis: the proportion of successful 1st intubation attempt is the same for both groups||||0.57
72374433|NCT01054183|144259282|NON_INFERIORITY_OR_EQUIVALENCE|powered for 62 patients||||||0.002||95.0|||||z test, two-sided|||Null hypothesis: overall successful intubation rate is the same for both groups.||||0.002
72374434|NCT02112045|144259286|SUPERIORITY|||||||0.43|||||||Log Rank|||||||0.43
72374435|NCT02112045|144259287|SUPERIORITY|||||||0.6|||||||Log Rank|||||||0.60
72374436|NCT02775240|144259290|OTHER||Ratio of geometric means|1.248|||||TWO_SIDED|90.0|1.13|1.378|||Linear mixed effects model||Log-transformed Cmax values were compared between treatment regimens using a linear mixed effects model with treatment regimen as fixed effect and participant as random effect.|Comparison of Treatment B over Treatment A for Cmax of Digoxin||1.378|1.130|
72374437|NCT02775240|144259291|OTHER||Ratio of geometric means|0.944|||||TWO_SIDED|90.0|0.778|1.144|||Linear mixed effects model|||Comparison of Treatment B over Treatment A for Cmax of Dextromethorphan||1.144|0.778|
72433533|NCT04888585|144380258|SUPERIORITY||Response Rate Difference|25.8|||<|0.001|TWO_SIDED|95.0|13.5|38.1|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted for the stratification factors.|Response Rate Difference = ABBV-154 150mg EOW - Placebo|||38.1|13.5|<0.001
72374438|NCT02775240|144259292|OTHER||Ratio of geometric means|0.943|||||TWO_SIDED|90.0|0.883|1.007|||Linear mixed effects model||Log-transformed Cmax values were compared between treatment regimens using a linear mixed effects model with treatment regimen as fixed effect and participant as random effect.|Comparison of Treatment B over Treatment A for Cmax of Dextrorphan||1.007|0.883|
72374439|NCT02775240|144259298|OTHER||Ratio of geometric means|1.206|||||TWO_SIDED|90.0|1.099|1.324|||Linear mixed effects model||Log-transformed AUC0-infinity values were compared between treatment regimens using a linear mixed effects model with treatment regimen as fixed effect and participant as random effect.|Comparison of Treatment B over Treatment A for AUC0-infinity of Digoxin||1.324|1.099|
72374440|NCT02775240|144259300|OTHER||Ratio of geometric means|0.971|||||TWO_SIDED|90.0|0.943|0.999|||Linear mixed effects model||Log-transformed AUC0-infinity values were compared between treatment regimens using a linear mixed effects model with treatment regimen as fixed effect and participant as random effect.|Comparison of Treatment B over Treatment A for AUC0-infinity of Dextrorphan||0.999|0.943|
72374441|NCT02775240|144259301|OTHER||Ratio of geometric means|1.179|||||TWO_SIDED|90.0|1.08|1.287|||Linear mixed effects model||Log-transformed AUClast values were compared between treatment regimens using a linear mixed effects model with treatment regimen as fixed effect and participant as random effect.|Comparison of Treatment B over Treatment A for AUClast for Digoxin||1.287|1.080|
72374442|NCT02775240|144259302|OTHER||Ratio of geometric means|0.882|||||TWO_SIDED|90.0|0.696|1.118|||Linear mixed effects model||Log-transformed AUClast values were compared between treatment regimens using a linear mixed effects model with treatment regimen as fixed effect and participant as random effect.|Comparison of Treatment B over Treatment A for AUClast of Dextromethorphan||1.118|0.696|
72374443|NCT02775240|144259303|OTHER||Ratio of geometric means|0.973|||||TWO_SIDED|90.0|0.949|0.998|||Linear mixed effects model||Log-transformed AUClast values were compared between treatment regimens using a linear mixed effects model with treatment regimen as fixed effect and participant as random effect.|Comparison of Treatment B over Treatment A for AUClast for Dextrorphan||0.998|0.949|
72374444|NCT02775240|144259304|OTHER||Ratio of geometric means|0.905|||||TWO_SIDED|90.0|0.721|1.138|||Linear mixed effects model||Log-transformed AUClast ratio values were compared between treatment regimens using a linear mixed effects model with treatment regimen as fixed effect and participant as random effect.|Comparison of Treatment B over Treatment A for Dextromethorphan/Dextrorphan (Parent/Metabolite) AUClast ratio||1.138|0.721|
72374445|NCT00977080|144259323|SUPERIORITY_OR_OTHER|||||||0.016|TWO_SIDED|95.0||||No adjustments were made for multiple comparisons between treatment groups since the study was designed to evaluate the primary outcome measure by testing a single hypothesis within each stratum independently.|Fisher Exact|||With a sample size of 49 participants in each treatment group in the IV stratum, a Fisher's exact test with a 0.050 2-sided significance level will have 81% power to detect a 30% difference in the percentage of participants who achieve iPTH between 150 and 300 pg/mL, assuming the cinacalcet percentage is 36% and the paricalcitol percentage is 66%.||||0.016
72374446|NCT00977080|144259323|SUPERIORITY_OR_OTHER|||||||0.26|TWO_SIDED|95.0||||No adjustments were made for multiple comparisons between treatment groups since the study was designed to evaluate the primary outcome measure by testing a single hypothesis within each stratum independently.|Fisher Exact|||With a sample size of 49 participants in each treatment group in the oral stratum, a Fisher's exact test with a 0.050 2-sided significance level will have 81% power to detect a 30% difference in the percentage of participants who achieve iPTH between 150 and 300 pg/mL, assuming the cinacalcet percentage is 36% and the paricalcitol percentage is 66%.||||0.260
72374447|NCT00977080|144259324|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Fisher Exact|||||||<0.001
72374448|NCT00977080|144259324|SUPERIORITY_OR_OTHER|||||||0.239||95.0|||||Fisher Exact|||||||0.239
72374449|NCT00977080|144259325|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Fisher Exact|||||||<0.001
72374450|NCT00977080|144259325|SUPERIORITY_OR_OTHER|||||||0.704||95.0|||||Fisher Exact|||||||0.704
72374451|NCT00977080|144259326|SUPERIORITY_OR_OTHER|||||||0.01||95.0|||||Cochran-Mantel-Haenszel|||||||0.010
72374452|NCT00977080|144259327|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Fisher Exact|||||||<0.001
72374453|NCT00977080|144259327|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Fisher Exact|||||||<0.001
72374454|NCT00977080|144259328|SUPERIORITY_OR_OTHER|||||||0.118||95.0|||||Fisher Exact|||||||0.118
72374455|NCT00977080|144259328|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|||||||1.00
72433534|NCT04888585|144380258|SUPERIORITY||Response Rate Difference|31.5|||<|0.001|TWO_SIDED|95.0|18.9|44.2|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted for the stratification factors.|Response Rate Difference = ABBV-154 340mg EOW - Placebo|||44.2|18.9|<0.001
72555616|NCT03100344|144642385|SUPERIORITY||mean difference of percentage changes|-28.7|||<|0.001|TWO_SIDED|95.0|-40.7|-16.8|||Kenward Roger|||Week 16||-16.8|-40.7|<0.001
72374456|NCT00441116|144259332|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|7.54|STANDARD_DEVIATION|20.37||0.0319||95.0|0.75|14.33|||t-test, 2 sided||Mean difference = Drug A minus Drug B|Month 6 - Baseline||14.33|0.75|0.0319
72374457|NCT03192358|144259364|SUPERIORITY||Cohen's d|1.18|||<|0.001|TWO_SIDED|||||A priori threshold for statistical significance was p \< 0.05.|ANOVA||Cohen's d values \> 0.8 are considered large|This was an observational study. The statistical test explores whether there were significant differences in tongue pressure between the two cohorts. The hypothesis was that individuals with ALS would display significantly lower maximum anterior isometric tongue pressures compared to the people with PD.||||< 0.001
72374458|NCT03192358|144259365|SUPERIORITY||Cohen's d|1.75|||<|0.001|TWO_SIDED||||||ANOVA||Cohen's d values \> 0.8 are considered large|This was an observational study rather than a trial. The hypothesis was that individuals with ALS would display significantly lower regular effort saliva swallow pressures than the individuals with PD.||||< 0.001
72374459|NCT04345367|144259423|SUPERIORITY||Estimate of difference|22.6|||<|0.0001|TWO_SIDED|95.0|15.8|29.5||Cochran-Mantel-Haenszel (CMH) method adjusted by baseline disease severity.|Cochran-Mantel-Haenszel||The estimate and confidence interval (CI) for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.|||29.5|15.8|<0.0001
72374460|NCT04345367|144259424|SUPERIORITY||Estimate of difference|14.1|||<|0.0001|TWO_SIDED|95.0|8.2|20.0||CMH method adjusted by baseline disease severity.|Cochran-Mantel-Haenszel||The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.|||20.0|8.2|<0.0001
72374461|NCT04345367|144259425|SUPERIORITY||Estimate of difference|12.5||||0.0008|TWO_SIDED|95.0|5.3|19.7||CMH method adjusted by baseline disease severity.|Cochran-Mantel-Haenszel||The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.|||19.7|5.3|0.0008
72374462|NCT04345367|144259426|OTHER||Estimate of difference|4.5|||||TWO_SIDED|95.0|0.2|8.7|||||Week 2. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.|||8.7|0.2|
72374463|NCT04345367|144259426|OTHER||Estimate of difference|20.0|||||TWO_SIDED|95.0|13.2|26.9|||||Week 8. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.|||26.9|13.2|
72374464|NCT04345367|144259426|OTHER||Estimate of difference|14.0|||||TWO_SIDED|95.0|6.9|21.1|||||Week 12. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.|||21.1|6.9|
72374465|NCT04345367|144259426|OTHER||Estimate of difference|12.7|||||TWO_SIDED|95.0|5.5|20.0|||||Week 20. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.|||20.0|5.5|
72374466|NCT04345367|144259426|OTHER||Estimate of difference|6.9|||||TWO_SIDED|95.0|-0.4|14.3|||||Week 26. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.|||14.3|-0.4|
72374467|NCT04345367|144259427|OTHER||Estimate of difference|8.1|||||TWO_SIDED|95.0|1.8|14.4|||||Week 2. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.|||14.4|1.8|
72493814|NCT02889796|144516582|SUPERIORITY||Difference in Response Rates|1.0||||0.17|TWO_SIDED|95.0|-0.5|2.6||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg vs Placebo at Week 2.||2.6|-0.5|0.17
72493815|NCT02889796|144516582|SUPERIORITY||Difference in Response Rates|10.7|||<|0.001|TWO_SIDED|95.0|7.1|14.4||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg vs Placebo at Week 4.||14.4|7.1|<0.001
72493816|NCT02889796|144516582|SUPERIORITY||Difference in Response Rates|5.8|||<|0.001|TWO_SIDED|95.0|2.6|9.0||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg vs Placebo at Week 4.||9.0|2.6|<0.001
72374468|NCT04345367|144259427|OTHER||Estimate of difference|20.9|||||TWO_SIDED|95.0|13.8|28.0|||||Week 4. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.|||28.0|13.8|
72374469|NCT04345367|144259427|OTHER||Estimate of difference|18.4|||||TWO_SIDED|95.0|11.4|25.3|||||Week 8. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.|||25.3|11.4|
72374470|NCT04345367|144259427|OTHER||Estimate of difference|14.9|||||TWO_SIDED|95.0|8.2|21.5|||||Week 12. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.|||21.5|8.2|
72374471|NCT04345367|144259427|OTHER||Estimate of difference|9.5|||||TWO_SIDED|95.0|3.0|16.0|||||Week 16. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.|||16.0|3.0|
72374472|NCT04345367|144259427|OTHER||Estimate of difference|5.0|||||TWO_SIDED|95.0|-1.4|11.5|||||Week 20. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.|||11.5|-1.4|
72374473|NCT04345367|144259427|OTHER||Estimate of difference|0.7|||||TWO_SIDED|95.0|-5.9|7.2|||||Week 26. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.|||7.2|-5.9|
72374474|NCT04345367|144259428|OTHER||Estimate of difference|7.3|||||TWO_SIDED|95.0|2.8|11.7|||||Week 2. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.|||11.7|2.8|
72374475|NCT04345367|144259428|OTHER||Estimate of difference|20.6|||||TWO_SIDED|95.0|14.3|26.9|||||Week 4. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.|||26.9|14.3|
72374476|NCT04345367|144259428|OTHER||Estimate of difference|19.5|||||TWO_SIDED|95.0|12.5|26.4|||||Week 8. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.|||26.4|12.5|
72374477|NCT04345367|144259428|OTHER||Estimate of difference|15.8|||||TWO_SIDED|95.0|8.7|23.0|||||Week 12. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.|||23.0|8.7|
72374478|NCT04345367|144259428|OTHER||Estimate of difference|13.0|||||TWO_SIDED|95.0|5.9|20.2|||||Week 16. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.|||20.2|5.9|
72374479|NCT04345367|144259428|OTHER||Estimate of difference|9.2|||||TWO_SIDED|95.0|2.0|16.4|||||Week 20. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.|||16.4|2.0|
72493817|NCT02889796|144516582|SUPERIORITY||Difference in Response Rates|32.2|||<|0.001|TWO_SIDED|95.0|26.4|38.0||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg vs Placebo at Week 24.||38.0|26.4|<0.001
72374480|NCT04345367|144259428|OTHER||Estimate of difference|4.5|||||TWO_SIDED|95.0|-2.8|11.8|||||Week 26. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.|||11.8|-2.8|
72374481|NCT04345367|144259429|OTHER||Estimate of difference|7.1|||||TWO_SIDED|95.0|3.1|11.1|||||Day 2. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.|||11.1|3.1|
72374482|NCT04345367|144259429|OTHER||Estimate of difference|6.5|||||TWO_SIDED|95.0|1.7|11.3|||||Day 3. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.|||11.3|1.7|
72374483|NCT04345367|144259429|OTHER||Estimate of difference|11.4|||||TWO_SIDED|95.0|6.0|16.8|||||Day 4. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.|||16.8|6.0|
72374484|NCT04345367|144259429|OTHER||Estimate of difference|14.5|||||TWO_SIDED|95.0|8.8|20.3|||||Day 5. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.|||20.3|8.8|
72374485|NCT04345367|144259429|OTHER||Estimate of difference|12.9|||||TWO_SIDED|95.0|6.9|19.0|||||Day 6. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.|||19.0|6.9|
72374486|NCT04345367|144259429|OTHER||Estimate of difference|19.9|||||TWO_SIDED|95.0|13.8|26.0|||||Day 7. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.|||26.0|13.8|
72374487|NCT04345367|144259429|OTHER||Estimate of difference|22.1|||||TWO_SIDED|95.0|15.9|28.3|||||Day 8. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.|||28.3|15.9|
72374488|NCT04345367|144259429|OTHER||Estimate of difference|21.7|||||TWO_SIDED|95.0|15.2|28.1|||||Day 9. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.|||28.1|15.2|
72374489|NCT04345367|144259429|OTHER||Estimate of other|21.3|||||TWO_SIDED|95.0|14.7|27.9|||||Day 10. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.|||27.9|14.7|
72433535|NCT04888585|144380258|SUPERIORITY||Response Rate Difference|23.2|||<|0.001|TWO_SIDED|95.0|11.0|35.4|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted for the stratification factors.|Response Rate Difference = ABBV-154 340mg E4W - Placebo|||35.4|11.0|<0.001
72374490|NCT04345367|144259429|OTHER||Estimate of difference|20.0|||||TWO_SIDED|95.0|13.3|26.6|||||Day 11. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.|||26.6|13.3|
72374491|NCT04345367|144259429|OTHER||Estimate of difference|21.3|||||TWO_SIDED|95.0|14.6|27.9|||||Day 12. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.|||27.9|14.6|
72374492|NCT04345367|144259429|OTHER||Estimate of difference|22.5|||||TWO_SIDED|95.0|15.8|29.2|||||Day 13. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.|||29.2|15.8|
72374493|NCT04345367|144259429|OTHER||Estimate of difference|22.4|||||TWO_SIDED|95.0|15.6|29.2|||||Day 14. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.|||29.2|15.6|
72374494|NCT04345367|144259429|OTHER||Estimate of difference|22.9|||||TWO_SIDED|95.0|16.0|29.9|||||Day 15. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.|||29.9|16.0|
72374495|NCT04345367|144259430|OTHER||Estimate of difference|17.3|||||TWO_SIDED|95.0|10.1|24.5|||||Week 4. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.|||24.5|10.1|
72374496|NCT04345367|144259430|OTHER||Estimate of difference|13.0|||||TWO_SIDED|95.0|6.0|20.1|||||Week 8. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.|||20.1|6.0|
72374497|NCT04345367|144259430|OTHER||Estimate of difference|4.4|||||TWO_SIDED|95.0|-2.5|11.4|||||Week 12. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.|||11.4|-2.5|
72374498|NCT04345367|144259430|OTHER||Estimate of difference|3.6|||||TWO_SIDED|95.0|-3.4|10.5|||||Week 16. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.|||10.5|-3.4|
72374499|NCT04345367|144259430|OTHER||Estimate of difference|2.0|||||TWO_SIDED|95.0|-4.9|9.0|||||Week 20. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.|||9.0|-4.9|
72374500|NCT04345367|144259430|OTHER||Estimate of difference|5.0|||||TWO_SIDED|95.0|-1.9|11.9|||||Week 26. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.|||11.9|-1.9|
72433536|NCT04888585|144380259|SUPERIORITY||Response Rate Difference|14.1||||0.022|TWO_SIDED|95.0|2.0|26.2|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted for the stratification factors.|Response Rate Difference = ABBV-154 40mg EOW - Placebo|||26.2|2.0|0.022
72433537|NCT04888585|144380259|SUPERIORITY||Response Rate Difference|22.8|||<|0.001|TWO_SIDED|95.0|10.0|35.5|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted for the stratification factors.|Response Rate Difference = ABBV-154 150mg EOW - Placebo|||35.5|10.0|<0.001
72555617|NCT03100344|144642385|SUPERIORITY||mean difference of percentage changes|-21.1||||0.001|TWO_SIDED|95.0|-33.7|-8.4|||Kenward Roger|||Week 20||-8.4|-33.7|0.001
72374501|NCT04345367|144259432|OTHER||Least square mean difference|-9.3|||||TWO_SIDED|95.0|-14.0|-4.6|||||Week 2. Analysis was performed using Mixed Model Repeated Measure (MMRM) with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||-4.6|-14.0|
72374502|NCT04345367|144259432|OTHER||Least square mean difference|-12.5|||||TWO_SIDED|95.0|-17.4|-7.6|||||Week 4. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||-7.6|-17.4|
72374503|NCT04345367|144259432|OTHER||Least square mean difference|-11.1|||||TWO_SIDED|95.0|-15.6|-6.6|||||Week 8. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||-6.6|-15.6|
72374504|NCT04345367|144259432|OTHER||Least square mean difference|-9.4|||||TWO_SIDED|95.0|-13.7|-5.1|||||Week 12. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||-5.1|-13.7|
72374505|NCT04345367|144259432|OTHER||Least square mean difference|-6.9|||||TWO_SIDED|95.0|-10.9|-2.9|||||Week 16. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||-2.9|-10.9|
72374506|NCT04345367|144259432|OTHER||Least square mean difference|-5.3|||||TWO_SIDED|95.0|-9.0|-1.7|||||Week 20. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||-1.7|-9.0|
72374507|NCT04345367|144259432|OTHER||Least square mean difference|-3.4|||||TWO_SIDED|95.0|-7.1|0.4|||||Week 26. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||0.4|-7.1|
72374508|NCT04345367|144259433|OTHER||Least square mean difference|-11.0|||||TWO_SIDED|95.0|-14.5|-7.6|||||Week 2. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||-7.6|-14.5|
72374509|NCT04345367|144259433|OTHER||Least square mean difference|-12.8|||||TWO_SIDED|95.0|-16.0|-9.5|||||Week 4. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||-9.5|-16.0|
72374510|NCT04345367|144259433|OTHER||Least square mean difference|-10.2|||||TWO_SIDED|95.0|-13.6|-6.8|||||Week 8. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||-6.8|-13.6|
72374511|NCT04345367|144259433|OTHER||Least square mean difference|-7.3|||||TWO_SIDED|95.0|-10.5|-4.1|||||Week 12. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||-4.1|-10.5|
72374512|NCT04345367|144259433|OTHER||Least square mean difference|-6.1|||||TWO_SIDED|95.0|-9.3|-3.0|||||Week 16. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||-3.0|-9.3|
72374513|NCT04345367|144259433|OTHER||Least square mean difference|-4.9|||||TWO_SIDED|95.0|-8.2|-1.7|||||Week 20. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||-1.7|-8.2|
72374514|NCT04345367|144259433|OTHER||Least square mean difference|-3.3|||||TWO_SIDED|95.0|-6.6|0.1|||||Week 26. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||0.1|-6.6|
72374515|NCT04345367|144259434|OTHER||Least square mean difference|0.0|||||TWO_SIDED|95.0|-0.4|0.4|||||Week 12. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||0.4|-0.4|
72374516|NCT04345367|144259434|OTHER||Least square mean difference|0.1|||||TWO_SIDED|95.0|-0.3|0.5|||||Week 16. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||0.5|-0.3|
72374517|NCT04345367|144259434|OTHER||Least square mean difference|0.1|||||TWO_SIDED|95.0|-0.3|0.6|||||Week 26. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||0.6|-0.3|
72374518|NCT04345367|144259435|OTHER||Least square mean difference|0.0|||||TWO_SIDED|95.0|-0.3|0.3|||||Week 12. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||0.3|-0.3|
72374519|NCT04345367|144259435|OTHER||Least square mean difference|0.1|||||TWO_SIDED|95.0|-0.2|0.5|||||Week 16. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||0.5|-0.2|
72374520|NCT04345367|144259435|OTHER||Least square mean difference|0.2|||||TWO_SIDED|95.0|-0.1|0.6|||||Week 26. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||0.6|-0.1|
72374521|NCT04345367|144259436|OTHER||Least square mean difference|-2.0|||||TWO_SIDED|95.0|-2.6|-1.3|||||Week 2. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||-1.3|-2.6|
72374522|NCT04345367|144259436|OTHER||Least square mean difference|-1.0|||||TWO_SIDED|95.0|-1.6|-0.4|||||Week 12. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||-0.4|-1.6|
72374523|NCT04345367|144259436|OTHER||Least square mean difference|-0.8|||||TWO_SIDED|95.0|-1.4|-0.2|||||Week 16. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||-0.2|-1.4|
72374524|NCT04345367|144259436|OTHER||Least square mean difference|-0.6|||||TWO_SIDED|95.0|-1.2|0.0|||||Week 20. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||0.0|-1.2|
72374525|NCT04345367|144259436|OTHER||Least square mean difference|-0.3|||||TWO_SIDED|95.0|-1.0|0.4|||||Week 26. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||0.4|-1.0|
72374526|NCT04345367|144259437|OTHER||Least square mean difference|0.818|||||TWO_SIDED|95.0|-1.22|2.856|||||Week 12. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||2.856|-1.220|
72374527|NCT04345367|144259437|OTHER||Least square mean difference|2.093|||||TWO_SIDED|95.0|-0.081|4.267|||||Week 16. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||4.267|-0.081|
72374528|NCT04345367|144259437|OTHER||Least square mean difference|-0.816|||||TWO_SIDED|95.0|-2.914|1.281|||||Week 26. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||1.281|-2.914|
72374529|NCT04345367|144259438|OTHER||Least square mean difference|-1.6|||||TWO_SIDED|95.0|-2.5|-0.7|||||Week 12. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||-0.7|-2.5|
72374530|NCT04345367|144259438|OTHER||Least square mean difference|-1.4|||||TWO_SIDED|95.0|-2.2|-0.5|||||Week 16. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||-0.5|-2.2|
72374531|NCT04345367|144259438|OTHER||Least square mean difference|-0.4|||||TWO_SIDED|95.0|-1.3|0.5|||||Week 26. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||0.5|-1.3|
72493818|NCT02889796|144516582|SUPERIORITY||Difference in Response Rates|19.0|||<|0.001|TWO_SIDED|95.0|13.4|24.6||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg vs Placebo at Week 24.||24.6|13.4|<0.001
72493819|NCT02889796|144516582|SUPERIORITY||Difference in Response Rates|12.7|||<|0.001|TWO_SIDED|95.0|5.6|19.9||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg vs Adalimumab at Week 24.||19.9|5.6|<0.001
72374532|NCT04345367|144259439|OTHER||Least square mean difference|0.2|||||TWO_SIDED|95.0|-0.1|0.6|||||Quantity of hours slept: Week 12. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||0.6|-0.1|
72374533|NCT04345367|144259439|OTHER||Least square mean difference|0.1|||||TWO_SIDED|95.0|-0.2|0.4|||||Quantity of hours slept: Week 16. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||0.4|-0.2|
72374534|NCT04345367|144259439|OTHER||Least square mean difference|0.1|||||TWO_SIDED|95.0|-0.2|0.4|||||Quantity of hours slept: Week 26. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||0.4|-0.2|
72493820|NCT02889796|144516582|SUPERIORITY||Difference in Response Rates|-0.5||||0.88|TWO_SIDED|95.0|-7.5|6.5||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg vs Adalimumab at Week 24.||6.5|-7.5|0.88
72493821|NCT02889796|144516582|NON_INFERIORITY|For non-inferiority test, the approach proposed by Liu 2014 was used to demonstrate that each filgotinib dose preserves more than 50% of the effect of adalimumab on the response rate of DAS28 (CRP) \< 2.6 at using NRI.|||||<|0.001||||||P-value of non-inferiority test was calculated from approach proposed by \[Liu 2014\].|Method proposed by [Liu 2014]|||Filgotinib 200 mg vs Adalimumab at Week 24.||||<0.001
72374535|NCT04345367|144259439|OTHER||Least square mean difference|1.2|||||TWO_SIDED|95.0|-0.9|3.4|||||Short of Breath or Headache score: Week 12. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||3.4|-0.9|
72374536|NCT04345367|144259439|OTHER||Least square mean difference|0.1|||||TWO_SIDED|95.0|-2.0|2.2|||||Short of Breath or Headache score: Week 16. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||2.2|-2.0|
72374537|NCT04345367|144259439|OTHER||Least square mean difference|0.6|||||TWO_SIDED|95.0|-1.5|2.6|||||Short of Breath or Headache score: Week 26. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||2.6|-1.5|
72374538|NCT04345367|144259439|OTHER||Least square mean difference|-1.8|||||TWO_SIDED|95.0|-4.2|0.5|||||Snoring score: Week 12. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||0.5|-4.2|
72374539|NCT04345367|144259439|OTHER||Least square mean difference|-0.9|||||TWO_SIDED|95.0|-3.3|1.5|||||Snoring score: Week 16. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||1.5|-3.3|
72374540|NCT04345367|144259439|OTHER||Least square mean difference|0.8|||||TWO_SIDED|95.0|-1.7|3.4|||||Snoring score: Week 26. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||3.4|-1.7|
72493822|NCT02889796|144516582|NON_INFERIORITY|For non-inferiority test, the approach proposed by Liu 2014 was used to demonstrate that each filgotinib dose preserves more than 50% of the effect of adalimumab on the response rate of DAS28 (CRP) \< 2.6 at using NRI.|||||<|0.001||||||P-value of non-inferiority test was calculated from approach proposed by \[Liu 2014\].|Method proposed by [Liu 2014]|||Filgotinib 100 mg vs Adalimumab at Week 24.||||<0.001
72555618|NCT03100344|144642385|SUPERIORITY||mean difference of percentage changes|-29.7|||<|0.001|TWO_SIDED|95.0|-42.1|-17.3|||Kenward Roger|||Week 20||-17.3|-42.1|<0.001
72493823|NCT02889796|144516588|SUPERIORITY||Least Squares Mean Difference|-4.6|STANDARD_ERROR_OF_MEAN|0.68|<|0.001|TWO_SIDED|95.0|-5.9|-3.2||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-3.2|-5.9|<0.001
72493824|NCT02889796|144516588|SUPERIORITY||Least Squares Mean Difference|-3.0|STANDARD_ERROR_OF_MEAN|0.68|<|0.001|TWO_SIDED|95.0|-4.3|-1.6||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-1.6|-4.3|<0.001
72493825|NCT02889796|144516588|SUPERIORITY||Least Squares Mean Difference|-5.2|STANDARD_ERROR_OF_MEAN|0.73|<|0.001|TWO_SIDED|95.0|-6.6|-3.8||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-3.8|-6.6|<0.001
72493826|NCT02889796|144516588|SUPERIORITY||Least Squares Mean Difference|-3.9|STANDARD_ERROR_OF_MEAN|0.73|<|0.001|TWO_SIDED|95.0|-5.3|-2.4||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-2.4|-5.3|<0.001
72493827|NCT02889796|144516588|SUPERIORITY||Least Squares Mean Difference|-5.9|STANDARD_ERROR_OF_MEAN|0.69|<|0.001|TWO_SIDED|95.0|-7.3|-4.6||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-4.6|-7.3|<0.001
72493828|NCT02889796|144516588|SUPERIORITY||Least Squares Mean Difference|-4.4|STANDARD_DEVIATION|0.69|<|0.001|TWO_SIDED|95.0|-5.8|-3.1||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-3.1|-5.8|<0.001
72493829|NCT02889796|144516588|SUPERIORITY||Least Squares Mean Difference|-5.7|STANDARD_ERROR_OF_MEAN|0.62|<|0.001|TWO_SIDED|95.0|-6.9|-4.5||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-4.5|-6.9|<0.001
72493830|NCT02889796|144516588|SUPERIORITY||Least Squares Mean Difference|-4.1|STANDARD_ERROR_OF_MEAN|0.62|<|0.001|TWO_SIDED|95.0|-5.3|-2.9||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-2.9|-5.3|<0.001
72493831|NCT02889796|144516590|SUPERIORITY||Least Squares Mean Difference|-5.7|STANDARD_ERROR_OF_MEAN|0.7|<|0.001|TWO_SIDED|95.0|-7.1|-4.4||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-4.4|-7.1|<0.001
72493832|NCT02889796|144516590|SUPERIORITY||Least Squares Mean Difference|-3.6|STANDARD_ERROR_OF_MEAN|0.7|<|0.001|TWO_SIDED|95.0|-5.0|-2.2||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-2.2|-5.0|<0.001
72493833|NCT02889796|144516590|SUPERIORITY||Least Squares Mean Difference|-6.1|STANDARD_ERROR_OF_MEAN|0.75|<|0.001|TWO_SIDED|95.0|-7.6|-4.6||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-4.6|-7.6|<0.001
72493834|NCT02889796|144516590|SUPERIORITY||Least Squares Mean Difference|-4.5|STANDARD_ERROR_OF_MEAN|0.75|<|0.001|TWO_SIDED|95.0|-6.0|-3.1||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-3.1|-6.0|<0.001
72504479|NCT00984659|144539586|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.08||||0.08||95.0|-0.02|0.19||ANCOVA adjusted for age, gender, and SOBDA Baseline score; comparison of mean SOBDA score for Participant-Completed mMRC responders and non-responders|ANCOVA|||||0.19|-0.02|0.08
72504480|NCT02951273|144539591|SUPERIORITY|||||||0.0276|||||||repeated measure mixed model|||||||0.0276
72374541|NCT04345367|144259439|OTHER||Least square mean difference|-4.1|||||TWO_SIDED|95.0|-6.6|-1.6|||||Sleep disturbance score: Week 12. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||-1.6|-6.6|
72374542|NCT04345367|144259439|OTHER||Least square mean difference|-3.8|||||TWO_SIDED|95.0|-6.2|-1.4|||||Sleep disturbance score: Week 16. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||-1.4|-6.2|
72374543|NCT04345367|144259439|OTHER||Least square mean difference|-1.7|||||TWO_SIDED|95.0|-4.1|0.7|||||Sleep disturbance score: Week 26. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||0.7|-4.1|
72374544|NCT04345367|144259439|OTHER||Least square mean difference|1.0|||||TWO_SIDED|95.0|-1.6|3.6|||||Sleep adequacy score: Week 12. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||3.6|-1.6|
72374545|NCT04345367|144259439|OTHER||Least square mean difference|2.9|||||TWO_SIDED|95.0|0.4|5.4|||||Sleep adequacy score: Week 16. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||5.4|0.4|
72374546|NCT04345367|144259439|OTHER||Least square mean difference|0.7|||||TWO_SIDED|95.0|-1.9|3.4|||||Sleep adequacy score: Week 26. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||3.4|-1.9|
72374547|NCT04345367|144259439|OTHER||Least square mean difference|-0.8|||||TWO_SIDED|95.0|-2.8|1.3|||||Sleep somnolence score: Week 12. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||1.3|-2.8|
72374548|NCT04345367|144259439|OTHER||Least square mean difference|-2.4|||||TWO_SIDED|95.0|-4.4|-0.4|||||Sleep somnolence score: Week 16. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||-0.4|-4.4|
72374549|NCT04345367|144259439|OTHER||Least square mean difference|-2.3|||||TWO_SIDED|95.0|-4.3|-0.3|||||Sleep somnolence score: Week 26. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||-0.3|-4.3|
72374550|NCT04345367|144259439|OTHER||Least square mean difference|-1.2|||||TWO_SIDED|95.0|-3.0|0.7|||||Sleep Problems Index I score: Week 12. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||0.7|-3.0|
72374551|NCT04345367|144259439|OTHER||Least square mean difference|-2.3|||||TWO_SIDED|95.0|-4.0|-0.5|||||Sleep Problems Index I score: Week 16. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||-0.5|-4.0|
72433538|NCT04888585|144380259|SUPERIORITY||Response Rate Difference|24.3|||<|0.001|TWO_SIDED|95.0|11.6|37.0|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted for the stratification factors.|Response Rate Difference = ABBV-154 340mg EOW - Placebo|||37.0|11.6|<0.001
72433539|NCT04888585|144380259|SUPERIORITY||Response Rate Difference|12.6||||0.042|TWO_SIDED|95.0|0.5|24.7|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted for the stratification factors.|Response Rate Difference = ABBV-154 340mg E4W - Placebo|||24.7|0.5|0.042
72374552|NCT04345367|144259439|OTHER||Least square mean difference|-0.8|||||TWO_SIDED|95.0|-2.5|0.9|||||Sleep Problems Index I score: Week 26. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||0.9|-2.5|
72374553|NCT04345367|144259439|OTHER||Least square mean difference|-2.2|||||TWO_SIDED|95.0|-4.0|-0.3|||||Sleep Problems Index II score: Week 12. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||-0.3|-4.0|
72374554|NCT04345367|144259439|OTHER||Least square mean difference|-2.9|||||TWO_SIDED|95.0|-4.8|-1.1|||||Sleep Problems Index II score: Week 16. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||-1.1|-4.8|
72374555|NCT04345367|144259439|OTHER||Least square mean difference|-1.4|||||TWO_SIDED|95.0|-3.2|0.4|||||Sleep Problems Index II score: Week 26. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||0.4|-3.2|
72374556|NCT04345367|144259440|OTHER||Least square mean difference|-1.1|||||TWO_SIDED|95.0|-1.5|-0.8|||||Week 2. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||-0.8|-1.5|
72374557|NCT04345367|144259440|OTHER||Least square mean difference|-0.4|||||TWO_SIDED|95.0|-0.8|-0.1|||||Week 12. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||-0.1|-0.8|
72374558|NCT04345367|144259440|OTHER||Least square mean difference|-0.2|||||TWO_SIDED|95.0|-0.6|0.1|||||Week 16. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||0.1|-0.6|
72374559|NCT04345367|144259440|OTHER||Least square mean difference|-0.3|||||TWO_SIDED|95.0|-0.6|0.0|||||Week 20. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||0.0|-0.6|
72433540|NCT04888585|144380260|SUPERIORITY||Response Rate Difference|5.1||||0.296|TWO_SIDED|95.0|-4.4|14.6|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted for the stratification factors.|Response Rate Difference = ABBV-154 40mg EOW - Placebo|||14.6|-4.4|0.296
72374560|NCT04345367|144259440|OTHER||Least square mean difference|-0.2|||||TWO_SIDED|95.0|-0.5|0.1|||||Week 26. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||0.1|-0.5|
72374561|NCT04345367|144259441|OTHER||Least square mean difference|18.1|||||TWO_SIDED|95.0|10.5|25.7||||||Analysis was performed using analysis of covariance (ANCOVA) model including treatment as a main effect and baseline disease severity as covariates.||25.7|10.5|
72374562|NCT04345367|144259442|OTHER||Estimate of difference|13.7|||||TWO_SIDED|95.0|7.3|20.1|||||Week 2. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.|||20.1|7.3|
72374563|NCT04345367|144259442|OTHER||Estimate of difference|3.9|||||TWO_SIDED|95.0|-1.6|9.4|||||Week 12. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.|||9.4|-1.6|
72374564|NCT04345367|144259442|OTHER||Estimate of difference|-1.6|||||TWO_SIDED|95.0|-7.1|4.0|||||Week 16. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.|||4.0|-7.1|
72374565|NCT04345367|144259442|OTHER||Estimate of difference|-2.0|||||TWO_SIDED|95.0|-7.6|3.6|||||Week 20. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.|||3.6|-7.6|
72374566|NCT04345367|144259442|OTHER||Estimate of difference|-4.2|||||TWO_SIDED|95.0|-10.3|1.9|||||Week 26. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.|||1.9|-10.3|
72374567|NCT01755026|144259464|SUPERIORITY_OR_OTHER||Mean Difference (Net)|191.0|STANDARD_ERROR_OF_MEAN|166.01|<|0.01|TWO_SIDED|95.0|||||t-test, 2 sided|||||||<0.01
72374568|NCT00392379|144259465|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.0|STANDARD_DEVIATION|43.0|<|0.05|TWO_SIDED|95.0||||No adjustment for multiple comparisons.|Regression, Logistic|||Based upon previous research, we hypothesized that the end-of-treatment abstinence rate for subjects receiving placebo would be 35% and the abstinence rate for subjects receiving the 4-mg nicotine lozenge would be 53%. A resulting power calculation indicated that 270 subjects (135 per group) were required in order to have 85% power to detect a significant difference (two-sided, α = 0.05 level test).||||<0.05
72374569|NCT02184624|144259468|SUPERIORITY_OR_OTHER||||||<|0.001||||||Statistical comparison for categories Error while using only ELLIPTA inhaler Vs Error while using DISKUS/ACCUHALER|Cochran-Mantel-Haenszel|||||||<0.001
72374570|NCT02184624|144259468|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical comparison for categories: Error while using only ELLIPTA inhaler Vs Error while using MDI|Cochran-Mantel-Haenszel|||||||<0.001
72374571|NCT02184624|144259468|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical comparison for categories: Error while using only ELLIPTA inhaler Vs Error while using TURBUHALER|Cochran-Mantel-Haenszel|||||||<0.001
72374572|NCT02184624|144259468|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical comparison for categories: Error while using only ELLIPTA inhaler Vs Error while using HANDIHALER|Cochran-Mantel-Haenszel|||||||<0.001
72374573|NCT02184624|144259468|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical comparison for categories: Error while using only ELLIPTA inhaler Vs Error while using BREEZHALER|Cochran-Mantel-Haenszel|||||||<0.001
72374574|NCT02184624|144259469|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical comparison for categories: Error while using only ELLIPTA inhaler Vs Error while using DISKUS/ACCUHALER|Cochran-Mantel-Haenszel|||||||<0.001
72374575|NCT02184624|144259469|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical comparison for categories: Error while using only ELLIPTA inhaler Vs Error while using MDI|Cochran-Mantel-Haenszel|||||||<0.001
72374576|NCT02184624|144259469|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical comparison for categories: Error while using only ELLIPTA inhaler Vs Error while using TURBUHALER|Cochran-Mantel-Haenszel|||||||<0.001
72374577|NCT02184624|144259469|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical comparison for categories: Error while using only ELLIPTA inhaler Vs Error while using HANDIHALER|Cochran-Mantel-Haenszel|||||||<0.001
72374578|NCT02184624|144259469|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical comparison for categories: Error while using only ELLIPTA inhaler Vs Error while using BREEZHALER|Cochran-Mantel-Haenszel|||||||<0.001
72374579|NCT02184624|144259470|SUPERIORITY_OR_OTHER|||||||0.48||95.0||||Statistical comparison for categories: Error while using only ELLIPTA inhaler Vs Error while using DISKUS/ACCUHALER|Cochran-Mantel-Haenszel|||||||0.480
72374580|NCT02184624|144259470|SUPERIORITY_OR_OTHER|||||||0.044||95.0||||Statistical comparison for categories: Error while using only ELLIPTA inhaler Vs Error while using MDI|Cochran-Mantel-Haenszel|||||||0.044
72374581|NCT02184624|144259470|SUPERIORITY_OR_OTHER|||||||0.025||95.0||||Statistical comparison for categories: Error while using only ELLIPTA inhaler Vs Error while using TURBUHALER|Cochran-Mantel-Haenszel|||||||0.025
72374582|NCT02184624|144259470|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical comparison for categories: Error while using only ELLIPTA inhaler Vs Error while using HANDIHALER|Cochran-Mantel-Haenszel|||||||<0.001
72374583|NCT02184624|144259470|SUPERIORITY_OR_OTHER|||||||0.014||95.0||||Statistical comparison for categories: Error while using only ELLIPTA inhaler Vs Error while using BREEZHALER|Cochran-Mantel-Haenszel|||||||0.014
72374584|NCT02184624|144259471|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical comparison for categories: Error while using only ELLIPTA inhaler Vs Error while using DISKUS/ACCUHALER|Cochran-Mantel-Haenszel|||||||<0.001
72374585|NCT02184624|144259471|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical comparison for categories: Error while using only ELLIPTA inhaler Vs Error while using MDI|Cochran-Mantel-Haenszel|||||||<0.001
72374586|NCT02184624|144259471|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||Statistical comparison for categories: Error while using only ELLIPTA inhaler Vs Error while using TURBUHALER|Cochran-Mantel-Haenszel|||||||0.002
72374587|NCT02184624|144259471|SUPERIORITY_OR_OTHER|||||||0.001||95.0||||Statistical comparison for categories: Error while using only ELLIPTA inhaler Vs Error while using HANDIHALER|Cochran-Mantel-Haenszel|||||||0.001
72374588|NCT02184624|144259471|SUPERIORITY_OR_OTHER|||||||0.003||95.0||||Statistical comparison for categories: Error while using only ELLIPTA inhaler Vs Error while using BREEZHALER|Cochran-Mantel-Haenszel|||||||0.003
72374589|NCT02184624|144259472|SUPERIORITY_OR_OTHER||||||<|0.001||||||Number of participants requiring instructions from the HCP (maximum three times) to demonstrate adequate inhalation technique of ELLIPTA inhaler versus those for DISKUS/ACCUHALER inhaler|Wilcoxon signed rank test|||||||<0.001
72374590|NCT02184624|144259472|SUPERIORITY_OR_OTHER||||||<|0.001||||||Number of participants requiring instructions from the HCP (maximum three times) to demonstrate adequate inhalation technique of ELLIPTA inhaler versus those for MDI inhaler|Wilcoxon signed rank test|||||||<0.001
72374591|NCT02184624|144259472|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Number of participants requiring instructions from the HCP (maximum three times) to demonstrate adequate inhalation technique of ELLIPTA inhaler versus those for TURBUHALER inhaler|Wilcoxon signed rank test|||||||<0.001
72374592|NCT02184624|144259472|SUPERIORITY_OR_OTHER||||||<|0.001||||||Number of participants requiring instructions from the HCP (maximum three times) to demonstrate adequate inhalation technique of ELLIPTA inhaler versus those for HANDIHALER inhaler|Wilcoxon signed rank test|||||||<0.001
72374593|NCT02184624|144259472|SUPERIORITY_OR_OTHER||||||<|0.001||||||Number of participants requiring instructions from the HCP (maximum three times) to demonstrate adequate inhalation technique of ELLIPTA inhaler versus those for BREEZHALER inhaler|Wilcoxon signed rank test|||||||<0.001
72374594|NCT02184624|144259473|SUPERIORITY_OR_OTHER||||||<|0.001||||||Number of participants preferring ELLIPTA device versus number of participants preferring DISKUS/ACCUHALER device as assessed by the 'preference' questionnaire|Cochran-Mantel-Haenszel|||||||<0.001
72374595|NCT02184624|144259473|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Number of participants preferring ELLIPTA device versus number of participants preferring MDI device as assessed by the 'preference' questionnaire|Cochran-Mantel-Haenszel|||||||<0.001
72374596|NCT02184624|144259473|SUPERIORITY_OR_OTHER||||||<|0.001||||||Number of participants preferring ELLIPTA device versus number of participants preferring TURBUHALER device as assessed by the 'preference' questionnaire|Cochran-Mantel-Haenszel|||||||<0.001
72374597|NCT02184624|144259473|SUPERIORITY_OR_OTHER||||||<|0.001||||||Number of participants preferring ELLIPTA device versus number of participants preferring HANDIHALER device as assessed by the 'preference' questionnaire|Cochran-Mantel-Haenszel|||||||<0.001
72374598|NCT02184624|144259473|SUPERIORITY_OR_OTHER||||||<|0.001||||||Number of participants preferring ELLIPTA device versus number of participants preferring BREEZHALER device as assessed by the 'preference' questionnaire|Cochran-Mantel-Haenszel|||||||<0.001
72374599|NCT02184624|144259474|SUPERIORITY_OR_OTHER||||||<|0.001||||||Number of participants preferring ELLIPTA device versus number of participants preferring DISKUS/ACCUHALER device by the 'ease of use' questionnaire|Cochran-Mantel-Haenszel|||||||<0.001
72374600|NCT02184624|144259474|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Number of participants preferring ELLIPTA device versus number of participants preferring MDI device by the 'ease of use' questionnaire|Cochran-Mantel-Haenszel|||||||<0.001
72374601|NCT02184624|144259474|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Number of participants preferring ELLIPTA device versus number of participants preferring TURBUHALER device by the 'ease of use' questionnaire|Cochran-Mantel-Haenszel|||||||<0.001
72374602|NCT02184624|144259474|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Number of participants preferring ELLIPTA device versus number of participants preferring HANDIHALER device by the 'ease of use' questionnaire|Cochran-Mantel-Haenszel|||||||<0.001
72374603|NCT02184624|144259474|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Number of participants preferring ELLIPTA device versus number of participants preferring BREEZHALER device by the 'ease of use' questionnaire|Cochran-Mantel-Haenszel|||||||<0.001
72374604|NCT02365233|144259477|SUPERIORITY||||||||||||||||||IRB withheld the data due to inadequate supporting documentation|||
72374605|NCT01978938|144259481|NON_INFERIORITY|The NI test was based on the lower limit of the 2-sided 95% confidence interval (CI), using the method proposed without stratification by Miettinen and Nurminen. If the lower limit of the 95% CI for the difference in Responder (clinical cure and microbiologic success) rates in the micro-ITT population exceeded -10%, then the null hypothesis was rejected and the NI of eravacycline to levofloxacin was declared.|Treatment Difference|-6.5|||||TWO_SIDED|95.0|-14.1|1.2||||||For the FDA, an NI margin of 10% was used, which was based on historical data regarding the treatment effect of antibiotics. A 10% NI margin for the Responder outcome is robust and can sufficiently confirm a clinically meaningful treatment effect of eravacycline in the treatment of cUTI.||1.2|-14.1|
72374606|NCT02342418|144259484|SUPERIORITY_OR_OTHER|||||||0.314|||||||Wilcoxon (Mann-Whitney)|||||||0.314
72374607|NCT02342418|144259485|SUPERIORITY_OR_OTHER|||||||0.214|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon matched-pair signed-rank test||||0.214
72374608|NCT00428584|144259490|SUPERIORITY_OR_OTHER|||||||0.524||||||P value refers to mean change to 30 minute post injection|ANOVA|||The primary efficacy endpoint was analyzed by using a two-way ANOVA model on ranked data including treatment group and site as fixed effect.||||0.524
72374609|NCT00428584|144259491|SUPERIORITY_OR_OTHER|||||||0.484|||||||ANOVA|||||||0.484
72374610|NCT00428584|144259492|SUPERIORITY_OR_OTHER|||||||0.838|||||||ANOVA|||||||0.838
72374611|NCT00428584|144259493|SUPERIORITY_OR_OTHER|||||||0.451||||||No pain is defined as a VAS = 0 for all 21 full dose injections.|Cochran-Mantel-Haenszel|||||||0.451
72374612|NCT00428584|144259494|SUPERIORITY_OR_OTHER|||||||0.338|||||||ANOVA|||||||0.338
72374613|NCT02285062|144259506|SUPERIORITY||Hazard Ratio (HR)|0.849||||0.2864|TWO_SIDED|95.0|0.632|1.14|||Log Rank|Stratified by: IPI score (2 or ≥ 3), presence or absence of bulky disease (diameter of the lesion ≥ 7 cm or \< 7 cm), and age (\< 65 or ≥ 65 years).|Hazard ratio was derived from Cox proportional hazard model adjusting for the 3 stratification factors|||1.140|0.632|0.2864
72374614|NCT02285062|144259507|SUPERIORITY||Hazard Ratio (HR)|1.038||||0.7294|TWO_SIDED|95.0|0.802|1.344|||Log Rank|Stratified by: IPI score (2 or ≥ 3), presence or absence of bulky disease (diameter of the lesion ≥ 7 cm or \< 7 cm), and age (\< 65 or ≥ 65 years).|Hazard ratio was derived from Cox proportional hazard model adjusting for the 3 stratification factors.|||1.344|0.802|0.7294
72395064|NCT00720434|144296638|SUPERIORITY_OR_OTHER||Difference in Proportions|0.125||||||95.0|-0.4024|0.6049||||||Week 4: The difference in proportions between treatment groups presented along with 95% CI, were based on exact method for small samples from the binomial distribution.||0.6049|-0.4024|
72493835|NCT02889796|144516590|SUPERIORITY||Least Squares Mean Difference|-6.8|STANDARD_ERROR_OF_MEAN|0.71|<|0.001|TWO_SIDED|95.0|-8.2|-5.4||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-5.4|-8.2|<0.001
72555619|NCT03100344|144642385|SUPERIORITY||mean difference of percentage changes|-27.9|||<|0.001|TWO_SIDED|95.0|-40.6|-15.2|||Kenward Roger|||Week 20||-15.2|-40.6|<0.001
72555620|NCT03100344|144642385|SUPERIORITY||mean difference of percentage changes|-22.4||||0.002|TWO_SIDED|95.0|-36.1|-8.6|||Kenward Roger|||Week 24||-8.6|-36.1|0.002
72555621|NCT03100344|144642385|SUPERIORITY||mean difference of percentage changes|-31.5|||<|0.001|TWO_SIDED|95.0|-44.9|-18.0|||Kenward Roger|||Week 24||-18.0|-44.9|<0.001
72555622|NCT03100344|144642385|SUPERIORITY||mean difference of percentage changes|-30.0|||<|0.001|TWO_SIDED|95.0|-43.8|-16.2|||Kenward Roger|||Week 24||-16.2|-43.8|<0.001
72555623|NCT03100344|144642387|SUPERIORITY||Mean Difference (Final Values)|-2.0|||<|0.001|TWO_SIDED|95.0|-3.0|-1.0|||Kenward Roger|||Week 24||-1.0|-3.0|<0.001
72555624|NCT03100344|144642387|SUPERIORITY||Mean Difference (Final Values)|-2.8|||<|0.001|TWO_SIDED|95.0|-3.8|-1.8|||Kenward Roger|||Week 24||-1.8|-3.8|<0.001
72555625|NCT03100344|144642387|SUPERIORITY||Mean Difference (Final Values)|-2.3|||<|0.001|TWO_SIDED|95.0|-3.3|-1.3|||Kenward Roger|||Week 24||-1.3|-3.3|<0.001
72555626|NCT03100344|144642388|SUPERIORITY||Mean Difference (Final Values)|-1.9|||<|0.001|TWO_SIDED|95.0|-3.0|-0.9|||Kenward Roger|||Week 24||-0.9|-3.0|<0.001
72555627|NCT03100344|144642388|SUPERIORITY||Mean Difference (Final Values)|-2.6|||<|0.001|TWO_SIDED|95.0|-3.6|-1.6|||Kenward Roger|||Week 24||-1.6|-3.6|<0.001
72555628|NCT03100344|144642388|SUPERIORITY||Mean Difference (Final Values)|-2.1|||<|0.001|TWO_SIDED|95.0|-3.1|-1.1|||Kenward Roger|||Week 24||-1.1|-3.1|<0.001
72555629|NCT03100344|144642389|SUPERIORITY||mean difference of percentage changes|-23.8|||<|0.001|TWO_SIDED|95.0|-37.7|-9.9|||Kenward Roger|||Week 24||-9.9|-37.7|<0.001
72555630|NCT03100344|144642389|SUPERIORITY||mean difference of percentage changes|-31.4|||<|0.001|TWO_SIDED|95.0|-45.0|-17.7|||Kenward Roger|||Week 24||-17.7|-45.0|<0.001
72374615|NCT02285062|144259508|SUPERIORITY||Hazard Ratio (HR)|0.965||||0.876|TWO_SIDED|95.0|0.716|1.3|||Log Rank|Log-rank test stratified by 3 factors: IPI score (2 or ≥ 3), presence of bulky disease (bulky or nonbulky), and age (\< 65 or ≥ 65).|Hazard ratio was derived from Cox proportional hazard model adjusting for the 3 stratification factors.|||1.300|0.716|0.8760
72555631|NCT03100344|144642389|SUPERIORITY||mean difference of percentage changes|-29.2|||<|0.001|TWO_SIDED|95.0|-43.2|-15.2|||Kenward Roger|||Week 24||-15.2|-43.2|<0.001
72555632|NCT01935674|144642405|SUPERIORITY||Mean Difference (Net)|12.7||||0.003|TWO_SIDED|95.0|2.9|22.5||P-value from Wilcoxon rank-sum test; significance threshold set at α = 0.05. No adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|Two-sided test; analysis based on intention-to-treat population.||Comparison of percentage change in fasting total cholesterol from baseline to week 12 between rosuvastatin and PI/r switch groups. Wilcoxon rank-sum test used. Study powered to detect a 15% difference with 80% power and α = 0.05. All participants included in intention-to-treat analysis.||22.5|2.9|0.003
72555633|NCT01521780|144642415|SUPERIORITY_OR_OTHER||Within subject coefficient of variation|0.0803|||||ONE_SIDED|90.0||0.1163||||||||0.1163||
72555634|NCT01521780|144642416|SUPERIORITY_OR_OTHER||Within subject coefficient of variation|0.0555|||||ONE_SIDED|90.0||0.0733||||||||0.0733||
72555635|NCT03043872|144642420|SUPERIORITY||Hazard Ratio (HR)|0.73||||0.0047|TWO_SIDED|95.0|0.591|0.909||Analysis was performed using the stratified log-rank test, adjusting for planned platinum therapy in Cycle 1 (carboplatin or cisplatin), and using the rank tests of association approach.|Log Rank||The HR and confidence intervals (CIs) were calculated using a stratified Cox proportional hazards model, adjusting for planned platinum therapy in Cycle 1 (carboplatin or cisplatin), and ties handled by Efron approach.|D + EP vs EP. The global cohort interim analysis of OS was based on a Lan-DeMets alpha spending function with O'Brien Fleming type boundary, using the actual number of events observed as a proportion of the planned total. Boundary for declaring statistical significance was 0.0178 for a 4% overall alpha. Hazard Ratio (HR) \<1 favors D + EP to be associated with a longer OS than EP.||0.909|0.591|0.0047
72555636|NCT03043872|144642421|SUPERIORITY||Hazard Ratio (HR)|0.75||||0.0032|TWO_SIDED|95.0|0.625|0.91||Analysis was performed using the stratified log-rank test, adjusting for planned platinum therapy in Cycle 1 (carboplatin or cisplatin), and using the rank tests of association approach.|Log Rank||The HR and CIs were calculated using a stratified Cox proportional hazards model, adjusting for planned platinum therapy in Cycle 1 (carboplatin or cisplatin), and ties handled by Efron approach.|D + EP vs EP. HR \<1 favors D + EP to be associated with a longer OS than EP.||0.910|0.625|0.0032
72555637|NCT03043872|144642421|SUPERIORITY||Hazard Ratio (HR)|0.82||||0.0451|TWO_SIDED|95.0|0.682|0.995||Analysis was performed using the stratified log-rank test, adjusting for planned platinum therapy in Cycle 1 (carboplatin or cisplatin), and using the rank tests of association approach.|Log Rank||The HR and CIs were calculated using a stratified Cox proportional hazards model, adjusting for planned platinum therapy in Cycle 1 (carboplatin or cisplatin), and ties handled by Efron approach.|"D + T + EP vs EP. The alpha level applied at the global cohort final analysis was adjusted (using a generalized Haybittle-Peto method) to account for actual alpha spent at the interim analysis based on the actual final total number of events, and thus maintain control of overall Type I error. Boundary for declaring statistical significance was 0.0418 for a 5% overall alpha.~HR \<1 favors D + T + EP to be associated with a longer OS than EP."||0.995|0.682|0.0451
72618301|NCT00286455|144767662|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.036||||0.819|TWO_SIDED|95.0|-0.347|0.275||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.275|-0.347|0.819
72618302|NCT00286455|144767663|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.079||||0.642|TWO_SIDED|95.0|-0.411|0.253||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.253|-0.411|0.642
72493836|NCT02889796|144516590|SUPERIORITY||Least Squares Mean Difference|-5.1|STANDARD_ERROR_OF_MEAN|0.71|<|0.001|TWO_SIDED|95.0|-6.5|-3.7||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-3.7|-6.5|<0.001
72493837|NCT02889796|144516590|SUPERIORITY||Least Squares Mean Difference|-6.5|STANDARD_ERROR_OF_MEAN|0.65|<|0.001|TWO_SIDED|95.0|-7.8|-5.3||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-5.3|-7.8|<0.001
72493838|NCT02889796|144516590|SUPERIORITY||Least Squares Mean Difference|-4.8|STANDARD_ERROR_OF_MEAN|0.65|<|0.001|TWO_SIDED|95.0|-6.1|-3.5||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-3.5|-6.1|<0.001
72493839|NCT02889796|144516592|SUPERIORITY||Least Squares Mean Difference|-0.39||||0.042|TWO_SIDED|95.0|-0.77|-0.01||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.01|-0.77|0.042
72493840|NCT02889796|144516592|SUPERIORITY||Least Squares Mean Difference|-0.39||||0.039|TWO_SIDED|95.0|-0.77|-0.02||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.02|-0.77|0.039
72493841|NCT02889796|144516593|SUPERIORITY||Difference in non-progression rate|6.6||||0.002|TWO_SIDED|95.0|2.2|11.1||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg vs Placebo at Week 24 for change in mTSS ≤ 0.5.||11.1|2.2|0.002
72493842|NCT02889796|144516593|SUPERIORITY||Difference in non-progression rate|3.9||||0.073|TWO_SIDED|95.0|-0.8|8.6||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg vs Placebo at Week 24 for change in mTSS ≤ 0.5.||8.6|-0.8|0.073
72493843|NCT02889796|144516593|SUPERIORITY||Difference in non-progression rate|7.0||||0.009|TWO_SIDED|95.0|1.5|12.5||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg vs Placebo at Week 24 for change in mTSS ≤ 0.||12.5|1.5|0.009
72493844|NCT02889796|144516593|SUPERIORITY||Difference in non-progression rate|5.0||||0.061|TWO_SIDED|95.0|-0.6|10.6||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg vs Placebo at Week 24 for change in mTSS ≤ 0.||10.6|-0.6|0.061
72493845|NCT02889796|144516593|SUPERIORITY||Difference in non-progression rate|5.5||||0.004|TWO_SIDED|95.0|1.6|9.4||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg vs Placebo at Week 24 for change in mTSS ≤ SDC (1.36).||9.4|1.6|0.004
72493846|NCT02889796|144516593|SUPERIORITY||Difference in non-progression rate|4.7||||0.012|TWO_SIDED|95.0|0.7|8.8||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg vs Placebo at Week 24 for change in mTSS ≤ SDC (1.36).||8.8|0.7|0.012
72493847|NCT02889796|144516597|SUPERIORITY||Least Squares Mean Difference|2.7|STANDARD_ERROR_OF_MEAN|0.4|<|0.001|TWO_SIDED|95.0|1.9|3.4||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||3.4|1.9|<0.001
72493848|NCT02889796|144516597|SUPERIORITY||Least Squares Mean Difference|1.7|STANDARD_ERROR_OF_MEAN|0.4|<|0.001|TWO_SIDED|95.0|1.0|2.5||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||2.5|1.0|<0.001
72493849|NCT02889796|144516597|SUPERIORITY||Least Squares Mean Difference|3.1|STANDARD_ERROR_OF_MEAN|0.52|<|0.001|TWO_SIDED|95.0|2.1|4.1||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||4.1|2.1|<0.001
72493850|NCT02889796|144516597|SUPERIORITY||Least Squares Mean Difference|3.1|STANDARD_ERROR_OF_MEAN|0.52|<|0.001|TWO_SIDED|95.0|2.0|4.1||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||4.1|2.0|<0.001
72504481|NCT02951273|144539592|SUPERIORITY||||||<|0.0001|||||||repeated measure mixed model|||||||<0.0001
72504482|NCT02951273|144539593|SUPERIORITY|||||||0.6025|||||||Regression, Linear|||||||0.6025
72504483|NCT02951273|144539594|SUPERIORITY|||||||0.3213|||||||repeated measure mixed model|||||||0.3213
72493851|NCT02889796|144516601|SUPERIORITY||Least Squares Mean Difference|1.8|STANDARD_ERROR_OF_MEAN|0.48|<|0.001|TWO_SIDED|95.0|0.9|2.8||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||2.8|0.9|<0.001
72493852|NCT02889796|144516601|SUPERIORITY||Least Squares Mean Difference|1.5|STANDARD_ERROR_OF_MEAN|0.48||0.002|TWO_SIDED|95.0|0.6|2.5||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||2.5|0.6|0.002
72493853|NCT02889796|144516601|SUPERIORITY||Least Squares Mean Difference|1.5|STANDARD_ERROR_OF_MEAN|0.52||0.006|TWO_SIDED|95.0|0.4|2.5||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||2.5|0.4|0.006
72493854|NCT02889796|144516601|SUPERIORITY||Least Squares Mean Difference|1.7|STANDARD_ERROR_OF_MEAN|0.52||0.001|TWO_SIDED|95.0|0.7|2.7||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||2.7|0.7|0.001
72493855|NCT02889796|144516601|SUPERIORITY||Least Squares Mean Difference|0.9|STANDARD_ERROR_OF_MEAN|0.55||0.086|TWO_SIDED|95.0|-0.1|2.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||2.0|-0.1|0.086
72493856|NCT02889796|144516601|SUPERIORITY||Least Squares Mean Difference|0.9|STANDARD_ERROR_OF_MEAN|0.55||0.12|TWO_SIDED|95.0|-0.2|1.9||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||1.9|-0.2|0.12
72493857|NCT02889796|144516605|SUPERIORITY||Least Squares Mean Difference|2.8|STANDARD_ERROR_OF_MEAN|0.51|<|0.001|TWO_SIDED|95.0|1.8|3.8||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||3.8|1.8|<0.001
72493858|NCT02889796|144516605|SUPERIORITY||Least Squares Mean Difference|2.2|STANDARD_ERROR_OF_MEAN|0.51|<|0.001|TWO_SIDED|95.0|1.2|3.2||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||3.2|1.2|<0.001
72493859|NCT02889796|144516605|SUPERIORITY||Least Squares Mean Difference|2.6|STANDARD_ERROR_OF_MEAN|0.59|<|0.001|TWO_SIDED|95.0|1.5|3.8||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||3.8|1.5|<0.001
72493860|NCT02889796|144516605|SUPERIORITY||Least Squares Mean Difference|2.8|STANDARD_ERROR_OF_MEAN|0.59|<|0.001|TWO_SIDED|95.0|1.6|3.9||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||3.9|1.6|<0.001
72493861|NCT02889796|144516611|SUPERIORITY||Least Squares Mean Difference|2.0|STANDARD_ERROR_OF_MEAN|1.2||0.049|TWO_SIDED|95.0|0.0|5.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||5.0|0.0|0.049
72493862|NCT02889796|144516611|SUPERIORITY||Least Squares Mean Difference|2.0|STANDARD_ERROR_OF_MEAN|1.2||0.069|TWO_SIDED|95.0|0.0|5.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||5.0|-0.0|0.069
72374616|NCT02285062|144259509|SUPERIORITY|||||||0.2933||||||Obtained from CMH test adjusting for stratification factors: IPI score (2 or ≥ 3), presence of bulky disease (bulky or nonbulky), and age (\< 65 or ≥ 65)|Cochran-Mantel-Haenszel|||||||0.2933
72374617|NCT02285062|144259510|SUPERIORITY|||||||0.9964||||||Obtained from CMH test adjusting for stratification factors: IPI score (2 or ≥ 3), presence of bulky disease (bulky or nonbulky), and age (\< 65 or ≥ 65)|Cochran-Mantel-Haenszel|||||||0.9964
72493863|NCT02889796|144516611|SUPERIORITY||Least Squares Mean Difference|7.0|STANDARD_ERROR_OF_MEAN|1.3|<|0.001|TWO_SIDED|95.0|4.0|9.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||9.0|4.0|<0.001
72493864|NCT02889796|144516611|SUPERIORITY||Least Squares Mean Difference|6.0|STANDARD_ERROR_OF_MEAN|1.3|<|0.001|TWO_SIDED|95.0|4.0|9.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||9.0|4.0|<0.001
72493865|NCT02889796|144516611|SUPERIORITY||Least Squares Mean Difference|3.0|STANDARD_ERROR_OF_MEAN|1.5||0.06|TWO_SIDED|95.0|0.0|6.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||6.0|-0.0|0.060
72493866|NCT02889796|144516611|SUPERIORITY||Least Squares Mean Difference|5.0|STANDARD_ERROR_OF_MEAN|1.5||0.003|TWO_SIDED|95.0|2.0|8.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||8.0|2.0|0.003
72493867|NCT01394081|144516634|SUPERIORITY||||||<|0.0001|||||||Chi-squared, Corrected|||||||<.0001
72493868|NCT01394081|144516635|SUPERIORITY||||||<|0.0001|||||||Log Rank|log rank Mantel Cox χ2 = 25.4||||||<.0001
72493869|NCT02814565|144516648|SUPERIORITY|||||||0.6179|TWO_SIDED|95.0|||||Wilcoxon Rank Sum test|||The 2-sample Wilcoxon rank sum test was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 0.05 level of significance.||||0.6179
72493870|NCT02814565|144516649|SUPERIORITY|||||||0.4338|||||||Wilcoxon Rank Sum Test|||Day 7. The 2-sample Wilcoxon rank sum test was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 0.05 level of significance.||||0.4338
72374618|NCT02285062|144259511|SUPERIORITY||Hazard Ratio (HR)|0.776||||0.2143|TWO_SIDED|95.0|0.521|1.157|||Log Rank|Stratified by: IPI score (2 or ≥ 3), presence or absence of bulky disease (diameter of the lesion ≥ 7 cm or \< 7 cm), and age (\< 65 or ≥ 65 years).|HR was derived from COX model adjusting for the 3 stratification factors mentioned above.|||1.157|0.521|0.2143
72493871|NCT02814565|144516649|SUPERIORITY|||||||0.1657|||||||Wilcoxon Rank Sum Test|||Day 14. The 2-sample Wilcoxon rank sum test was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 0.05 level of significance.||||0.1657
72493872|NCT02814565|144516650|SUPERIORITY|||||||0.0393|||||||Wilcoxon Sum Rank Test|||The 2-sample Wilcoxon sum rank test was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 0.05 level of significance.||||0.0393
72493873|NCT02814565|144516651|SUPERIORITY|||||||0.033|||||||Wilcoxon Sum Rank Test|||Day 7. The 2-sample Wilcoxon sum rank test was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 0.05 level of significance.||||0.0330
72374619|NCT02285062|144259512|SUPERIORITY||Hazard Ratio (HR)|1.167||||0.315||95.0|0.856|1.59|||Log Rank|Stratified by: IPI score (2 or ≥ 3), presence or absence of bulky disease (diameter of the lesion ≥ 7 cm or \< 7 cm), and age (\< 65 or ≥ 65 years).|HR is derived from Cox model|||1.590|0.856|0.3150
72493874|NCT02814565|144516651|SUPERIORITY|||||||0.0262|||||||Wilcoxon Sum Rank Test|||Day 15. The 2-sample Wilcoxon sum rank test was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 0.05 level of significance.||||0.0262
72493875|NCT02814565|144516652|SUPERIORITY|||||||0.5756|||||||Wilcoxon Sum Rank Test|||Day 3. The 2-sample Wilcoxon sum rank test was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 0.05 level of significance.||||0.5756
72493876|NCT02814565|144516652|SUPERIORITY|||||||0.4395|||||||Wilcoxon Sum Rank Test|||Day 7. The 2-sample Wilcoxon sum rank test was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 0.05 level of significance.||||0.4395
72493877|NCT02814565|144516652|SUPERIORITY|||||||0.0905|||||||Wilcoxon Sum Rank Test|||Day 14. The 2-sample Wilcoxon sum rank test was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 0.05 level of significance.||||0.0905
72493878|NCT02814565|144516653|SUPERIORITY|||||||1|||||||Fisher Exact|||"Day 3. A two-tailed Fisher's exact test to compare the number of responders between the Placebo and the Cyclobenzaprine HCl 15 mg treatment group to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 0.05 level of significance."||||1.0000
72493879|NCT02814565|144516653|SUPERIORITY|||||||1|||||||Fisher Exact|||"Day 7. A two-tailed Fisher's exact test to compare the number of responders between the Placebo and the Cyclobenzaprine HCl 15 mg treatment group to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 0.05 level of significance."||||1.0000
72504484|NCT02951273|144539595|SUPERIORITY|||||||0.0005||||||The reported p-value was calculated|repeated measure mixed model|||||||0.0005
72504485|NCT02951273|144539596|SUPERIORITY|||||||0.5404|||||||repeated measure mixed model|||||||0.5404
72374620|NCT01947855|144259527|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-104.87|STANDARD_ERROR_OF_MEAN|19.88|<|0.0001|TWO_SIDED|95.0|-144.77|-64.97|||ANCOVA|Model includes treatment, number of previous antidiabetic medication, baseline renal function, baseline HbA1c and baseline AUC1-4h for plasma glucose.||Difference calculated as empa 25 mg minus placebo. The analyses will be performed sequentially compared with placebo from high dose of empagliflozin and the full significance level (5%) will be maintained by the hierarchical procedure.||-64.97|-144.77|<0.0001
72504486|NCT02951273|144539597|SUPERIORITY|||||||0.8947|||||||repeated measure mixed model|||||||0.8947
72493880|NCT02814565|144516653|SUPERIORITY|||||||0.2757|||||||Fisher Exact|||"Day 14. A two-tailed Fisher's exact test to compare the number of responders between the Placebo and the Cyclobenzaprine HCl 15 mg treatment group to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 0.05 level of significance."||||0.2757
72555638|NCT03043872|144642422|OTHER||Hazard Ratio (HR)|0.65||||0.0664|TWO_SIDED|95.0|0.414|1.029||Analysis was performed using the stratified log-rank test, adjusting for planned platinum therapy in Cycle 1 (carboplatin or cisplatin), and using the rank tests of association approach.|Log Rank||The HR and CIs were calculated using a stratified Cox proportional hazards model, adjusting for planned platinum therapy in Cycle 1 (carboplatin or cisplatin), and ties handled by Efron approach.|D + EP vs EP. HR \<1 favors D + EP to be associated with a longer OS than EP. The study was not designed or powered to show statistical significance for efficacy endpoints in the China cohort, so all statistical analyses for the China cohort were considered exploratory.||1.029|0.414|0.0664
72555639|NCT03043872|144642423|OTHER||Hazard Ratio (HR)|0.75||||0.1455|TWO_SIDED|95.0|0.504|1.106||Analysis was performed using the stratified log-rank test, adjusting for planned platinum therapy in Cycle 1 (carboplatin or cisplatin), and using the rank tests of association approach.|Log Rank||The HR and CIs were calculated using a stratified Cox proportional hazards model, adjusting for planned platinum therapy in Cycle 1 (carboplatin or cisplatin), and ties handled by Efron approach.|D + EP vs EP. HR \<1 favors D + EP to be associated with a longer OS than EP. The study was not designed or powered to show statistical significance for efficacy endpoints in the China cohort, so all statistical analyses for the China cohort were considered exploratory.||1.106|0.504|0.1455
72555640|NCT03043872|144642423|OTHER||Hazard Ratio (HR)|0.65||||0.0314|TWO_SIDED|95.0|0.439|0.964||Analysis was performed using the stratified log-rank test, adjusting for planned platinum therapy in Cycle 1 (carboplatin or cisplatin), and using the rank tests of association approach.|Log Rank||The HR and CIs were calculated using a stratified Cox proportional hazards model, adjusting for planned platinum therapy in Cycle 1 (carboplatin or cisplatin), and ties handled by Efron approach.|D + T + EP vs EP. HR \<1 favors D + T + EP to be associated with a longer OS than EP. The study was not designed or powered to show statistical significance for efficacy endpoints in the China cohort, so all statistical analyses for the China cohort were considered exploratory.||0.964|0.439|0.0314
72555641|NCT03043872|144642424|SUPERIORITY||Hazard Ratio (HR)|1.08||||0.4352|TWO_SIDED|95.0|0.89|1.309||Analysis was performed using the stratified log-rank test, adjusting for planned platinum therapy in Cycle 1 (carboplatin or cisplatin), and using the rank tests of association approach.|Log Rank||The HR and CIs were calculated using a stratified Cox proportional hazards model, adjusting for planned platinum therapy in Cycle 1 (carboplatin or cisplatin), and ties handled by Efron approach.|D + T + EP vs D + EP. HR \<1 favors D + T + EP to be associated with a longer OS than D + EP.||1.309|0.890|0.4352
72555642|NCT03043872|144642425|SUPERIORITY||Hazard Ratio (HR)|0.8||||0.0157|TWO_SIDED|95.0|0.665|0.959||Analysis was performed using the stratified log-rank test, adjusting for planned platinum therapy in Cycle 1 (carboplatin or cisplatin), and using the rank tests of association approach.|Log Rank||The HR and CIs were calculated using a stratified Cox proportional hazards model, adjusting for planned platinum therapy in Cycle 1 (carboplatin or cisplatin), and ties handled by Efron approach.|D + EP vs EP. HR \<1 favors D + EP to be associated with a longer PFS than EP.||0.959|0.665|0.0157
72555643|NCT03043872|144642425|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.0568|TWO_SIDED|95.0|0.696|1.005||Analysis was performed using the stratified log-rank test, adjusting for planned platinum therapy in Cycle 1 (carboplatin or cisplatin), and using the rank tests of association approach.|Log Rank||The HR and CIs were calculated using a stratified Cox proportional hazards model, adjusting for planned platinum therapy in Cycle 1 (carboplatin or cisplatin), and ties handled by Efron approach.|D + T + EP vs EP. HR \<1 favors D + T + EP to be associated with a longer PFS than EP.||1.005|0.696|0.0568
72618303|NCT00286455|144767663|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.003||||0.986|TWO_SIDED|95.0|-0.332|0.338||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.338|-0.332|0.986
72618304|NCT00286455|144767664|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.686||||0.305|TWO_SIDED|95.0|0.622|4.571|||Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, diabetes duration and baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||4.571|0.622|0.305
72618305|NCT00286455|144767664|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.349||||0.091|TWO_SIDED|95.0|0.873|6.321|||Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, diabetes duration and baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||6.321|0.873|0.091
72493881|NCT02814565|144516654|SUPERIORITY|||||||0.302|||||||Wilcoxon Sum Rank Test|||Day 3. The 2-sample Wilcoxon sum rank test was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 0.05 level of significance.||||0.3020
72493882|NCT02814565|144516654|SUPERIORITY|||||||0.2367|||||||Wilcoxon Sum Rank Test|||Day 7. The 2-sample Wilcoxon sum rank test was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 0.05 level of significance.||||0.2367
72493883|NCT02814565|144516654|SUPERIORITY|||||||0.025|||||||Wilcoxon Sum Rank Test|||Day 15. The 2-sample Wilcoxon sum rank test was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 0.05 level of significance.||||0.0250
72493884|NCT02814565|144516655|SUPERIORITY|||||||0.4428|||||||Wilcoxon Sum Rank Test|||Day 3. The 2-sample Wilcoxon sum rank test was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 0.05 level of significance.||||0.4428
72493885|NCT02814565|144516655|SUPERIORITY|||||||0.1163|||||||Wilcoxon Sum Rank Test|||Day 7. The 2-sample Wilcoxon sum rank test was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 0.05 level of significance.||||0.1163
72493886|NCT02814565|144516655|SUPERIORITY|||||||0.0489|||||||Wilcoxon Sum Rank Test|||Day 15. The 2-sample Wilcoxon sum rank test was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 0.05 level of significance.||||0.0489
72618306|NCT00286455|144767665|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.704||||0.001|TWO_SIDED|95.0|1.694|8.1|||Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, diabetes duration and baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||8.100|1.694|0.001
72618307|NCT00286455|144767665|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.305||||0.003|TWO_SIDED|95.0|1.505|7.255|||Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, diabetes duration and baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||7.255|1.505|0.003
72618308|NCT00286455|144767666|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.905||||0.006|TWO_SIDED|95.0|1.359|6.21|||Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, diabetes duration and baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||6.210|1.359|0.006
72618309|NCT00286455|144767666|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.552|||<|0.001|TWO_SIDED|95.0|2.068|10.017|||Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, diabetes duration and baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||10.017|2.068|<0.001
72504487|NCT02951273|144539598|SUPERIORITY|||||||0.0068|||||||Linear mixed models|||||||0.0068
72504488|NCT02951273|144539599|SUPERIORITY||||||<|0.0001|||||||repeated measure mixed model|||||||<0.0001
72504489|NCT02951273|144539600|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||||||<0.0001
72504490|NCT02951273|144539601|SUPERIORITY||||||<|0.0001|||||||repeated measure mixed model|||||||<0.0001
72504491|NCT02951273|144539602|SUPERIORITY||||||<|0.0001|||||||repeated measure mixed model|||||||<0.0001
72504492|NCT00121225|144539607|SUPERIORITY|||||||0.029|||||||Fisher Exact|||||||0.029
72504493|NCT02424149|144539690|SUPERIORITY_OR_OTHER|||||||0.77|||||||t-test, 2 sided|||||||0.77
72504494|NCT02424149|144539691|SUPERIORITY_OR_OTHER|||||||0.73|||||||t-test, 2 sided|||||||0.73
72504495|NCT02424149|144539692|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||||||1.0
72504496|NCT02424149|144539693|SUPERIORITY_OR_OTHER|||||||0.78|||||||t-test, 2 sided|||||||0.78
72504497|NCT02424149|144539694|SUPERIORITY_OR_OTHER|||||||0.04|||||||Fisher Exact|||||||0.04
72504498|NCT02255838|144539735|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|paired t-test||||||<0.05
72504499|NCT01515072|144539743|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.08||||0.38|TWO_SIDED|95.0|-0.37|0.21||This is an unadjusted comparison. P value \< 0.05|t-test, 2 sided|Adjusted analyses for the RIPC effect are provided below.|0.08 less organs per donor in the RIPC group.|Sample Size and Power estimation: A sample size of at least 150 donors in each arm was estimated to provide 80% power to detect a difference of 0.44 of an organ recovered and 0.48 of an organ transplanted per donor. The difference criterion was chosen based on published results achieved with hormonal resuscitation in organ donors. 6 Pooled standard deviations (organs recovered: 1.35; organs transplanted: 1.5) from data of two OPOs were used.||0.21|-0.37|0.38
72504500|NCT01515072|144539744|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.03||||0.7|TWO_SIDED|95.0|-0.33|0.26||This is an unadjusted analysis. P \< 0.05|t-test, 2 sided|Adjusted analyses are provided below.|0.03 less organs per donor in the RIPC group.|Sample Size A sample size of at least 150 donors in each arm was estimated to provide 80% power to detect a difference of 0.44 of an organ recovered and 0.48 of an organ transplanted per donor. The difference criterion was chosen based on published results achieved with hormonal resuscitation in organ donors. 6 Pooled standard deviations (organs recovered: 1.35; organs transplanted: 1.5) from data of two OPOs were used.||0.26|-0.33|0.70
72504501|NCT01515072|144539745|SUPERIORITY_OR_OTHER|||||||0.63||||||P\<0.05|Wilcoxon (Mann-Whitney)|This is an unadjusted comparison||||||0.63
72504502|NCT01515072|144539746|SUPERIORITY_OR_OTHER|||||||0.86|||||||Wilcoxon (Mann-Whitney)|||||||0.86
72504503|NCT01515072|144539747|SUPERIORITY_OR_OTHER|||||||0.55||||||P\<0.05|Wilcoxon (Mann-Whitney)|This is an unadjusted comparison||||||0.55
72504504|NCT01515072|144539748|SUPERIORITY_OR_OTHER|||||||0.55||||||P\<0.05|Wilcoxon (Mann-Whitney)|This is an unadjusted comparison||||||0.55
72504505|NCT01515072|144539749|SUPERIORITY_OR_OTHER|||||||0.48||||||P\<0.05|Wilcoxon (Mann-Whitney)|This is an unadjusted comparison||||||0.48
72504506|NCT01515072|144539750|SUPERIORITY_OR_OTHER|||||||0.04||||||P\<0.05|Wilcoxon (Mann-Whitney)|This is an unadjusted comparison||||||0.04
72504507|NCT01515072|144539751|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-4.7||||0.53|TWO_SIDED|95.0|-10.1|19.5||P\<0.05|Regression, Linear|Final flow was modeled on RIPC and adjusted for donor stratum and duration of perfusion|Data shown above is the the adjusted mean difference in final flow in RIPC group|||19.5|-10.1|0.53
72504508|NCT01515072|144539752|SUPERIORITY_OR_OTHER|||||||0.97|||||||Wilcoxon (Mann-Whitney)|||||||0.97
72504509|NCT01515072|144539753|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.62||||0.07|TWO_SIDED|95.0|0.95|2.76||Adjusted analysis with recipient age as a continuous variable, sex, race as black versus not black, body mass index, diabetes, hypertension,antigen mismatches, donor age as a continuous variable and trial site.|Chi-squared|||||2.76|0.95|0.07
72504510|NCT01515072|144539753|SUPERIORITY_OR_OTHER|||||||0.36||||||Unadjusted analysis|Chi-squared|||||||0.36
72504511|NCT01515072|144539754|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||0.006|TWO_SIDED|95.0|0.03|0.17|||Regression, Linear|Final resistance was modeled on RIPC and adjusted for donor stratum and duration of perfusion.|Data shown above is the adjusted mean difference in final resistance in the RIPC group.|||0.17|0.03|0.006
72504512|NCT01515072|144539755|SUPERIORITY_OR_OTHER|||||||0.5|||||||Fisher Exact|This is an unadjusted comparison||||||0.50
72504513|NCT01515072|144539756|SUPERIORITY_OR_OTHER|||||||0.03|||||||Log Rank|This is an unadjusted comparison||||||0.03
72504514|NCT01515072|144539757|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.19||||0.01|TWO_SIDED|95.0|0.04|0.9|||Log Rank|Results of adjusted Cox proportional hazard analyses for six month death-censored kidney graft survival are shown below|The proportional hazard ratio favors RIPC group|||0.90|0.04|0.01
72504515|NCT01515072|144539758|SUPERIORITY_OR_OTHER|||||||0.37|||||||Log Rank|This is an unadjusted comparison||||||0.37
72504516|NCT01508676|144539759|SUPERIORITY_OR_OTHER|||||||0.04|||||||t-test, 2 sided|||||||.04
72395065|NCT00720434|144296638|SUPERIORITY_OR_OTHER||Difference in Proportions|-0.15|||||TWO_SIDED|95.0|-0.5729|0.3149||||||Week 4: The difference in proportions between treatment groups presented along with 95% CI, were based on exact method for small samples from the binomial distribution.||0.3149|-0.5729|
72555644|NCT03043872|144642425|SUPERIORITY||Hazard Ratio (HR)|1.03||||0.754|TWO_SIDED|95.0|0.857|1.235||Analysis was performed using the stratified log-rank test, adjusting for planned platinum therapy in Cycle 1 (carboplatin or cisplatin), and using the rank tests of association approach.|Log Rank||The HR and CIs were calculated using a stratified Cox proportional hazards model, adjusting for planned platinum therapy in Cycle 1 (carboplatin or cisplatin), and ties handled by Efron approach.|D + T + EP vs D + EP. HR \<1 favors D + T + EP to be associated with a longer PFS than D + EP.||1.235|0.857|0.7540
72555645|NCT03043872|144642426|SUPERIORITY||Odds Ratio (OR)|1.61||||0.0177|TWO_SIDED|95.0|1.086|2.401||Analysis was performed using a logistic regression model, adjusting for planned platinum therapy in Cycle 1 (carboplatin or cisplatin). P-value is based on twice the change in log-likelihood resulting from addition of a treatment factor to the model.|Regression, Logistic|||D + EP vs EP. An odds ratio \>1 favors D + EP.||2.401|1.086|0.0177
72555646|NCT03043872|144642426|SUPERIORITY||Odds Ratio (OR)|1.19||||0.3611|TWO_SIDED|95.0|0.817|1.746||Analysis was performed using a logistic regression model, adjusting for planned platinum therapy in Cycle 1 (carboplatin or cisplatin). P-value is based on twice the change in log-likelihood resulting from addition of a treatment factor to the model.|Regression, Logistic|||D + T + EP vs EP. An odds ratio \>1 favors D + T + EP.||1.746|0.817|0.3611
72555647|NCT03043872|144642438|OTHER||Hazard Ratio (HR)|0.86||||0.447|TWO_SIDED|95.0|0.574|1.277||Analysis was performed using the stratified log-rank test, adjusting for planned platinum therapy in Cycle 1 (carboplatin or cisplatin), and using the rank tests of association approach.|Log Rank||The HR and CIs were calculated using a stratified Cox proportional hazards model, adjusting for planned platinum therapy in Cycle 1 (carboplatin or cisplatin), and ties handled by Efron approach.|D + T + EP vs D + EP. HR \<1 favors D + T + EP to be associated with a longer OS than D + EP. The study was not designed or powered to show statistical significance for efficacy endpoints in the China cohort, so all statistical analyses for the China cohort were considered exploratory.||1.277|0.574|0.4470
72555648|NCT03043872|144642439|OTHER||Hazard Ratio (HR)|0.97||||0.8934|TWO_SIDED|95.0|0.661|1.437||Analysis was performed using the stratified log-rank test, adjusting for planned platinum therapy in Cycle 1 (carboplatin or cisplatin), and using the rank tests of association approach.|Log Rank||The HR and CIs were calculated using a stratified Cox proportional hazards model, adjusting for planned platinum therapy in Cycle 1 (carboplatin or cisplatin), and ties handled by Efron approach.|D + EP vs EP. HR \<1 favors D + EP to be associated with a longer PFS than EP. The study was not designed or powered to show statistical significance for efficacy endpoints in the China cohort, so all statistical analyses for the China cohort were considered exploratory.||1.437|0.661|0.8934
72555649|NCT03043872|144642439|OTHER||Hazard Ratio (HR)|0.72||||0.1035|TWO_SIDED|95.0|0.487|1.068||Analysis was performed using the stratified log-rank test, adjusting for planned platinum therapy in Cycle 1 (carboplatin or cisplatin), and using the rank tests of association approach.|Log Rank||The HR and CIs were calculated using a stratified Cox proportional hazards model, adjusting for planned platinum therapy in Cycle 1 (carboplatin or cisplatin), and ties handled by Efron approach.|D + T + EP vs EP. HR \<1 favors D + T + EP to be associated with a longer PFS than EP. The study was not designed or powered to show statistical significance for efficacy endpoints in the China cohort, so all statistical analyses for the China cohort were considered exploratory.||1.068|0.487|0.1035
72555650|NCT03043872|144642439|OTHER||Hazard Ratio (HR)|0.76||||0.1673|TWO_SIDED|95.0|0.522|1.116||Analysis was performed using the stratified log-rank test, adjusting for planned platinum therapy in Cycle 1 (carboplatin or cisplatin), and using the rank tests of association approach.|Log Rank||The HR and CIs were calculated using a stratified Cox proportional hazards model, adjusting for planned platinum therapy in Cycle 1 (carboplatin or cisplatin), and ties handled by Efron approach.|D + T + EP vs D + EP. HR \<1 favors D + T + EP to be associated with a longer PFS than D + EP. The study was not designed or powered to show statistical significance for efficacy endpoints in the China cohort, so all statistical analyses for the China cohort were considered exploratory.||1.116|0.522|0.1673
72618310|NCT00286455|144767667|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.663||||0.004|TWO_SIDED|95.0|1.367|5.188|||Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, diabetes duration and baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||5.188|1.367|0.004
72618311|NCT00286455|144767667|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.277|||<|0.001|TWO_SIDED|95.0|1.671|6.429|||Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, diabetes duration and baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||6.429|1.671|<0.001
72555651|NCT03043872|144642440|OTHER||Odds Ratio (OR)|1.39||||0.432|TWO_SIDED|95.0|0.61|3.244||Analysis was performed using a logistic regression model, adjusting for planned platinum therapy in Cycle 1 (carboplatin or cisplatin). P-value is based on twice the change in log-likelihood resulting from addition of a treatment factor to the model.|Regression, Logistic|||D + EP vs EP. An odds ratio \>1 favors D + EP. The study was not designed or powered to show statistical significance for efficacy endpoints in the China cohort, so all statistical analyses for the China cohort were considered exploratory.||3.244|0.610|0.4320
72618312|NCT00286455|144767668|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.331||||0.002|TWO_SIDED|95.0|1.714|10.947|||Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, diabetes duration and baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||10.947|1.714|0.002
72493887|NCT02814565|144516656|SUPERIORITY|||||||0.5275|||||||Wilcoxon Sum Rank Test|||Day 3. The 2-sample Wilcoxon sum rank test was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 0.05 level of significance.||||0.5275
72395066|NCT00720434|144296638|SUPERIORITY_OR_OTHER||Difference in Proportions|0.3|||||TWO_SIDED|95.0|-0.1836|0.6931||||||Week 12: The difference in proportions between treatment groups presented along with 95% CI, were based on exact method for small samples from the binomial distribution.||0.6931|-0.1836|
72493888|NCT02814565|144516656|SUPERIORITY|||||||0.088|||||||Wilcoxon Sum Rank Test|||Day 7. The 2-sample Wilcoxon sum rank test was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 0.05 level of significance.||||0.0880
72493889|NCT02814565|144516656|SUPERIORITY|||||||0.2542|||||||Wilcoxon Sum Rank Test|||Day 15. The 2-sample Wilcoxon sum rank test was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 0.05 level of significance.||||0.2542
72493890|NCT02814565|144516657|SUPERIORITY|||||||0.692|||||||Wilcoxon Sum Rank Test|||Day 3. The 2-sample Wilcoxon sum rank test was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 0.05 level of significance.||||0.6920
72493891|NCT02814565|144516657|SUPERIORITY|||||||0.0749|||||||Wilcoxon Sum Rank Test|||Day 7. The 2-sample Wilcoxon sum rank test was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 0.05 level of significance.||||0.0749
72493892|NCT02814565|144516657|SUPERIORITY|||||||0.2371|||||||Wilcoxon Sum Rank Test|||Day 15. The 2-sample Wilcoxon sum rank test was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 0.05 level of significance.||||0.2371
72555652|NCT03043872|144642440|OTHER||Odds Ratio (OR)|2.07||||0.0986|TWO_SIDED|95.0|0.874|5.118||Analysis was performed using a logistic regression model, adjusting for planned platinum therapy in Cycle 1 (carboplatin or cisplatin). P-value is based on twice the change in log-likelihood resulting from addition of a treatment factor to the model.|Regression, Logistic|||D + T + EP vs EP. An odds ratio \>1 favors D + T + EP. The study was not designed or powered to show statistical significance for efficacy endpoints in the China cohort, so all statistical analyses for the China cohort were considered exploratory.||5.118|0.874|0.0986
72555653|NCT04115293|144642457|SUPERIORITY||LS Mean Difference|-2.09|||<|0.001|TWO_SIDED|95.0|-3.24|-0.95|||MMRM ANCOVA|||||-0.95|-3.24|<0.001
72555654|NCT04115293|144642458|SUPERIORITY||LS Mean Difference|-2.94|||<|0.001|TWO_SIDED|95.0|-4.39|-1.49|||MMRM ANCOVA|||||-1.49|-4.39|<0.001
72555655|NCT04115293|144642459|SUPERIORITY||LS Mean Difference|-3.2||||0.0023|TWO_SIDED|95.0|-5.24|-1.16|||MMRM ANCOVA|||||-1.16|-5.24|0.0023
72555656|NCT04115293|144642460|SUPERIORITY||LS Mean Difference|-2.49||||0.0128|TWO_SIDED|95.0|-4.45|-0.54|||MMRM ANCOVA|||||-0.54|-4.45|0.0128
72555657|NCT04115293|144642462|SUPERIORITY||Odds Ratio (OR)|2.608||||0.0885|TWO_SIDED|95.0|0.866|7.86|||Regression, Logistic|||||7.860|0.866|0.0885
72618313|NCT00286455|144767668|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.732||||0.001|TWO_SIDED|95.0|1.862|12.025|||Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, diabetes duration and baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||12.025|1.862|0.001
72395067|NCT00720434|144296638|SUPERIORITY_OR_OTHER||Difference in Proportions|0.375|||||TWO_SIDED|95.0|-0.1732|0.7797||||||Week 12: The difference in proportions between treatment groups presented along with 95% CI, were based on exact method for small samples from the binomial distribution.||0.7797|-0.1732|
72493893|NCT02479802|144516681|OTHER||||||<|0.0001|||||||t-test, 1 sided|||Change from Baseline at Week 48.||||<0.0001
72493894|NCT02479802|144516682|OTHER|||||||0.0006|||||||t-test, 1 sided|||Change from Baseline at Week 48.||||0.0006
72555658|NCT04115293|144642463|SUPERIORITY||Odds Ratio (OR)|3.184|||<|0.001|TWO_SIDED|95.0|1.662|6.101|||Regression, Logistic|||||6.101|1.662|<0.001
72555659|NCT04115293|144642464|SUPERIORITY||Odds Ratio (OR)|2.865||||0.0012|TWO_SIDED|95.0|1.518|5.409|||Regression, Logistic|||||5.409|1.518|0.0012
72555660|NCT02222818|144642486|NON_INFERIORITY_OR_EQUIVALENCE|In order to demonstrate that CAFRPlus is no less effective than CAFR by a non-inferiority margin of 2%, assuming a true paired difference of 6% and a standard deviation of 15% for the paired differences, a sample size of 39 subjects with paired data is required to achieve 90% statistical power using the one-sample t-test for non-inferiority, while controlling the one-sided type I error rate at 0.025.|Mean Difference (Net)|7.0|STANDARD_DEVIATION|8.7|<|0.0001|TWO_SIDED|95.86|4.5|9.5||The threshold for statistical significance was 0.0207, determined by the pre-specified alpha spending function accounting for one interim analysis.|t-test, 1 sided|||Null Hypothesis (Ho): μd ≤ -2% Alternative Hypothesis (Ha): μd \> -2% where μd is the paired difference in percent effective CRT pacing during AF between when CAFRPlus is applied and when CAFR is applied, based on subjects' paired measurements from the two cross-over follow-up periods, and -2% is the non-inferiority margin selected based upon clinical judgment.||9.5|4.5|<0.0001
72555661|NCT02222818|144642487|SUPERIORITY_OR_OTHER||Mean Difference (Net)|7.0|STANDARD_DEVIATION|8.7|<|0.0001|TWO_SIDED|95.86|4.5|9.5||The threshold for statistical significance was 0.0207, determined by the pre-specified alpha spending function accounting for one interim analysis.|t-test, 1 sided|||Null Hypothesis (Ho): μd ≤ 0% Alternative Hypothesis (Ha): μd \> 0% where μd is the paired difference in percent effective CRT pacing during AF between when CAFRPlus is applied and when CAFR is applied, based on subjects' paired measurements from the two cross-over follow-up periods.||9.5|4.5|<0.0001
72555662|NCT04516434|144642533|OTHER|Descriptive analysis||||||1|||||||Mixed Models Analysis|||Change from baseline to after the pressure-flow study||||1
72555663|NCT04516434|144642533|OTHER|Descriptive analysis||||||0.99|||||||Mixed Models Analysis|||Change from baseline to after the pressure-flow study||||0.99
72555664|NCT04516434|144642534|OTHER|Descriptive analysis||||||0.08|||||||Mixed Models Analysis|||Change from baseline to after the pressure-flow study||||0.08
72555665|NCT04516434|144642534|OTHER|Descriptive analysis||||||0.045|||||||Mixed Models Analysis|||Change from baseline to after the pressure-flow study||||0.045
72555666|NCT04516434|144642536|OTHER|Descriptive analysis||||||1|||||||Mixed Models Analysis|||First sensation of bladder filling - change in cystometry before stimulation and after stimulation (up to 60 minutes).||||1
72555667|NCT04516434|144642536|OTHER|Descriptive analysis||||||0.41|||||||Mixed Models Analysis|||First sensation of bladder filling - change in cystometry before stimulation and after stimulation (up to 60 minutes).||||0.41
72555668|NCT04516434|144642536|OTHER|Descriptive analysis||||||1|||||||Mixed Models Analysis|||Maximum cystometric capacity - change in cystometry before stimulation and after stimulation (up to 60 minutes).||||1
72555669|NCT04516434|144642536|OTHER|Descriptive analysis||||||0.01|||||||Mixed Models Analysis|||Maximum cystometric capacity - change in cystometry before stimulation and after stimulation (up to 60 minutes).||||0.01
72555670|NCT04516434|144642537|OTHER|Descriptive analysis||||||1|||||||Mixed Models Analysis|||Change from baseline to after the pressure-flow study||||1
72555671|NCT04516434|144642537|OTHER|Descriptive analysis||||||1|||||||Mixed Models Analysis|||Change from baseline to after the pressure-flow study||||1
72555672|NCT04516434|144642538|OTHER|Descriptive analysis||||||1|||||||Mixed Models Analysis|||Change from baseline to after the pressure-flow study||||1
72555673|NCT04516434|144642538|OTHER|Descriptive analysis||||||0.99|||||||Mixed Models Analysis|||Change from baseline to after the pressure-flow study||||0.99
72555674|NCT02545283|144642576|SUPERIORITY||Hazard Ratio (HR)|1.08||||0.5752|TWO_SIDED|95.0|0.81|1.45|||Log Rank|||||1.45|0.81|0.5752
72555675|NCT02826694|144642615|OTHER|||||||0.168|||||||linear mixed effect model|||T3||||0.168
72555676|NCT02826694|144642615|OTHER|||||||0.026|||||||linear mixed effect model|||T4||||0.026
72555677|NCT03264092|144642660|OTHER|This was just a comparative study. No superiority, equivalence or non inferiority analysis was performed.||||||0.18|||||||Fisher Exact|||||||0.18
72618314|NCT00286455|144767669|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.766||||0.153|TWO_SIDED|95.0|0.685|11.16|||Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, diabetes duration and baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||11.160|0.685|0.153
72618315|NCT00286455|144767669|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.632||||0.029|TWO_SIDED|95.0|1.169|18.354|||Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, diabetes duration and baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||18.354|1.169|0.029
72555678|NCT03264092|144642661|OTHER|This was just a comparative study. No superiority, equivalence or non inferiority analysis was performed.||||||0.41|||||||Fisher Exact|||||||0.41
72555679|NCT03264092|144642662|OTHER|This was just a comparative study. No superiority, equivalence or non inferiority analysis was performed.||||||0.45|||||||Fisher Exact|||||||0.45
72555680|NCT02558491|144642693|OTHER|||||||0.045||||||No a priori sample size was determined due to the feasibility/pilot nature of the trial. Significance level was set at P-value \<0.05.|ANOVA|||Primary statistical analysis was performed using the repeated measure ANOVA, with the treatment mode as within subject factor, and type of insulin treatment (pump vs. MDI) as between subject factor. Based on achieved recruitment, a moderate effect size (0.3) is detectable with 80% power, or a large effect size (0.4) with 95% power (G-Power 3.1.9.2). Outcome measurement was for overall.||||0.045
72555681|NCT02558491|144642693|OTHER|||||||0.07||||||No a priori sample size was determined due to the feasibility/pilot nature of the trial. Significance level was set at P-value \<0.05.|ANOVA|||Primary statistical analysis was performed using the repeated measure ANOVA, with the treatment mode as within subject factor, and type of insulin treatment (pump vs. MDI) as between subject factor. Based on achieved recruitment, a moderate effect size (0.3) is detectable with 80% power, or a large effect size (0.4) with 95% power (G-Power 3.1.9.2). Outcome measurement was for mealtime.||||0.07
72555682|NCT02558491|144642693|OTHER|||||||0.177||||||No a priori sample size was determined due to the feasibility/pilot nature of the trial. Significance level was set at P-value \<0.05.|ANOVA|||Primary statistical analysis was performed using the repeated measure ANOVA, with the treatment mode as within subject factor, and type of insulin treatment (pump vs. MDI) as between subject factor. Based on achieved recruitment, a moderate effect size (0.3) is detectable with 80% power, or a large effect size (0.4) with 95% power (G-Power 3.1.9.2). Outcome measurement was for overnight.||||0.177
72555683|NCT02558491|144642694|OTHER|||||||0.042||||||No a priori sample size was determined due to the feasibility/pilot nature of the trial. Significance level was set at P-value \<0.05.|ANOVA|||Secondary analysis followed the same format unless variables could not be considered normally distributed; in that case a related samples Wilcoxon signed-rank test was used. Data were first binned (to ensure minimum count of five per bins) \& w2 statistics was used with expected counts given by standard of care. Based on achieved recruitment, moderate effect size (0.3) was detectable with 80% power, or large effect size (0.4) with 95% power (G-Power 3.1.9.2). Outcome measurement was for overall.||||0.042
72555684|NCT02558491|144642694|OTHER|||||||0.276||||||No a priori sample size was determined due to the feasibility/pilot nature of the trial. Significance level was set at P-value \<0.05.|ANOVA|||Secondary analysis followed the same format unless variables could not be considered normally distributed; in that case a related samples Wilcoxon signed-rank test is used. Data were first binned (to ensure minimum count of five per bins) and the w2 statistics was used with the expected counts given by SoC. Based on achieved recruitment, a moderate effect size (0.3) is detectable with 80% power, or a large effect size (0.4) with 95% power (G-Power 3.1.9.2). Outcome measurement was for overnight.||||0.276
72555685|NCT02558491|144642695|OTHER|||||||0.026||||||No a priori sample size was determined due to the feasibility/pilot nature of the trial. Significance level was set at P-value \<0.05.|Wilcoxon (Mann-Whitney)|||Secondary analysis followed the same format unless variables could not be considered normally distributed; in that case a related samples Wilcoxon signed-rank test is used. Data were first binned (to ensure minimum count of five per bins) and the w2 statistics was used with the expected counts given by SoC. Based on achieved recruitment, a moderate effect size (0.3) is detectable with 80% power, or a large effect size (0.4) with 95% power (G-Power 3.1.9.2). Outcome measurement was for overall.||||0.026
72555686|NCT02558491|144642695|OTHER|||||||0.173||||||No a priori sample size was determined due to the feasibility/pilot nature of the trial. Significance level was set at P-value \<0.05.|Wilcoxon (Mann-Whitney)|||Secondary analysis followed the same format unless variables could not be considered normally distributed; in that case a related samples Wilcoxon signed-rank test is used. Data were first binned (to ensure minimum count of five per bins) and the w2 statistics was used with the expected counts given by SoC. Based on achieved recruitment, a moderate effect size (0.3) is detectable with 80% power, or a large effect size (0.4) with 95% power (G-Power 3.1.9.2). Outcome measurement was for mealtime.||||0.173
72618316|NCT00286455|144767670|SUPERIORITY_OR_OTHER|||||||0.102||95.0||||No multiplicity adjustments.|Mantel Haenszel|Odd's Ratio and 95% CI not estimable using logistic regression model. Tested using extended Mantel-Haenszel test.||||||0.102
72618317|NCT00286455|144767670|SUPERIORITY_OR_OTHER|||||||0.063||95.0||||No multiplicity adjustments.|Mantel Haenszel|Odd's Ratio and 95% CI not estimable using logistic regression model. Tested using extended Mantel-Haenszel test.||||||0.063
72504517|NCT00609128|144539770|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||ANOVA|ANOVA with preplanned comparisons was used to generate two tailed P values. Paired t tests were used to make appropriate post-ANOVA comparisons.||"tears were collected in season from eyes of allergic patients with or without olopatadine treatment, that is one eye was treated and the patients other eye was not.~Tears from each patient's eyes were pooled to provide enough volume."||||<0.05
72395068|NCT00720434|144296638|SUPERIORITY_OR_OTHER||Difference in Proportions|0.125|||||TWO_SIDED|95.0|-0.4024|0.6049||||||Week 12: The difference in proportions between treatment groups presented along with 95% CI, were based on exact method for small samples from the binomial distribution.||0.6049|-0.4024|
72395069|NCT00720434|144296638|SUPERIORITY_OR_OTHER||Difference in Proportions|0.175|||||TWO_SIDED|95.0|-0.2934|0.5917||||||Week 12: The difference in proportions between treatment groups presented along with 95% CI, were based on exact method for small samples from the binomial distribution.||0.5917|-0.2934|
72395070|NCT00720434|144296638|SUPERIORITY_OR_OTHER||Difference in Proportions|0.25|||||TWO_SIDED|95.0|-0.2913|0.696||||||Week 12: The difference in proportions between treatment groups presented along with 95% CI, were based on exact method for small samples from the binomial distribution.||0.6960|-0.2913|
72395071|NCT00720434|144296638|SUPERIORITY_OR_OTHER||Difference in Proportions|-0.075|||||TWO_SIDED|95.0|-0.5144|0.388||||||Week 12: The difference in proportions between treatment groups presented along with 95% CI, were based on exact method for small samples from the binomial distribution.||0.3880|-0.5144|
72555687|NCT02558491|144642695|OTHER|||||||0.715||||||No a priori sample size was determined due to the feasibility/pilot nature of the trial. Significance level was set at P-value \<0.05.|Wilcoxon (Mann-Whitney)|||Secondary analysis followed the same format unless variables could not be considered normally distributed; in that case a related samples Wilcoxon signed-rank test is used. Data were first binned (to ensure minimum count of five per bins) and the w2 statistics was used with the expected counts given by SoC. Based on achieved recruitment, a moderate effect size (0.3) is detectable with 80% power, or a large effect size (0.4) with 95% power (G-Power 3.1.9.2). Outcome measurement was for overnight.||||0.715
72555688|NCT02558491|144642696|OTHER|||||||0.036||||||No a priori sample size was determined due to the feasibility/pilot nature of the trial. Significance level was set at P-value \<0.05.|Wilcoxon (Mann-Whitney)|||Secondary analysis followed the same format unless variables could not be considered normally distributed; in that case a related samples Wilcoxon signed-rank test is used. Data were first binned (to ensure minimum count of five per bins) and the w2 statistics was used with the expected counts given by SoC. Based on achieved recruitment, a moderate effect size (0.3) is detectable with 80% power, or a large effect size (0.4) with 95% power (G-Power 3.1.9.2). Outcome measurement was for overall.||||0.036
72555689|NCT02558491|144642696|OTHER|||||||0.213||||||No a priori sample size was determined due to the feasibility/pilot nature of the trial. Significance level was set at P-value \<0.05.|Wilcoxon (Mann-Whitney)|||Secondary analysis followed the same format unless variables could not be considered normally distributed; in that case a related samples Wilcoxon signed-rank test is used. Data were first binned (to ensure minimum count of five per bins) and the w2 statistics was used with the expected counts given by SoC. Based on achieved recruitment, a moderate effect size (0.3) is detectable with 80% power, or a large effect size (0.4) with 95% power (G-Power 3.1.9.2). Outcome measurement was for mealtime.||||0.213
72555690|NCT02558491|144642696|OTHER|||||||0.11||||||No a priori sample size was determined due to the feasibility/pilot nature of the trial. Significance level was set at P-value \<0.05.|Wilcoxon (Mann-Whitney)|||Secondary analysis followed the same format unless variables could not be considered normally distributed; in that case a related samples Wilcoxon signed-rank test is used. Data were first binned (to ensure minimum count of five per bins) and the w2 statistics was used with the expected counts given by SoC. Based on achieved recruitment, a moderate effect size (0.3) is detectable with 80% power, or a large effect size (0.4) with 95% power (G-Power 3.1.9.2). Outcome measurement was for overnight.||||0.110
72555691|NCT02558491|144642697|OTHER|||||||0.018||||||No a priori sample size was determined due to the feasibility/pilot nature of the trial. Significance level was set at P-value \<0.05.|Wilcoxon (Mann-Whitney)|||Secondary analysis followed the same format unless variables could not be considered normally distributed; in that case a related samples Wilcoxon signed-rank test is used. Data were first binned (to ensure minimum count of five per bins) and the w2 statistics was used with the expected counts given by SoC. Based on achieved recruitment, a moderate effect size (0.3) is detectable with 80% power, or a large effect size (0.4) with 95% power (G-Power 3.1.9.2). Outcome measurement was for overall.||||0.018
72555692|NCT02558491|144642697|OTHER|||||||0.149||||||No a priori sample size was determined due to the feasibility/pilot nature of the trial. Significance level was set at P-value \<0.05.|Wilcoxon (Mann-Whitney)|||Secondary analysis followed the same format unless variables could not be considered normally distributed; in that case a related samples Wilcoxon signed-rank test is used. Data were first binned (to ensure minimum count of five per bins) and the w2 statistics was used with the expected counts given by SoC. Based on achieved recruitment, a moderate effect size (0.3) is detectable with 80% power, or a large effect size (0.4) with 95% power (G-Power 3.1.9.2). Outcome measurement was for mealtime.||||0.149
72555693|NCT02558491|144642697|OTHER|||||||0.109||||||No a priori sample size was determined due to the feasibility/pilot nature of the trial. Significance level was set at P-value \<0.05.|Wilcoxon (Mann-Whitney)|||Secondary analysis followed the same format unless variables could not be considered normally distributed; in that case a related samples Wilcoxon signed-rank test is used. Data were first binned (to ensure minimum count of five per bins) and the w2 statistics was used with the expected counts given by SoC. Based on achieved recruitment, a moderate effect size (0.3) is detectable with 80% power, or a large effect size (0.4) with 95% power (G-Power 3.1.9.2). Outcome measurement was for overnight.||||0.109
72555694|NCT02558491|144642698|OTHER|||||||0.78||||||No a priori sample size was determined due to the feasibility/pilot nature of the trial. Significance level was set at P-value \<0.05.|ANOVA|||Secondary analysis followed the same format unless variables could not be considered normally distributed; in that case a related samples Wilcoxon signed-rank test is used. Data were first binned (to ensure minimum count of five per bins) and the w2 statistics was used with the expected counts given by SoC. Based on achieved recruitment, a moderate effect size (0.3) is detectable with 80% power, or a large effect size (0.4) with 95% power (G-Power 3.1.9.2). Outcome measurement was for overall.||||0.78
72395072|NCT00720434|144296638|SUPERIORITY_OR_OTHER||Difference in Proportions|0.1|||||TWO_SIDED|95.0|-0.3728|0.5414||||||Week 48: The difference in proportions between treatment groups presented along with 95% CI, were based on exact method for small samples from the binomial distribution.||0.5414|-0.3728|
72555695|NCT02558491|144642698|OTHER|||||||0.399||||||No a priori sample size was determined due to the feasibility/pilot nature of the trial. Significance level was set at P-value \<0.05.|ANOVA|||Secondary analysis followed the same format unless variables could not be considered normally distributed; in that case a related samples Wilcoxon signed-rank test is used. Data were first binned (to ensure minimum count of five per bins) and the w2 statistics was used with the expected counts given by SoC. Based on achieved recruitment, a moderate effect size (0.3) is detectable with 80% power, or a large effect size (0.4) with 95% power (G-Power 3.1.9.2). Outcome measurement was for mealtime.||||0.399
72618318|NCT00286455|144767671|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.37||||0.186|TWO_SIDED|95.0|-0.18|0.93||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.93|-0.18|0.186
72618319|NCT00286455|144767671|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.34||||0.237|TWO_SIDED|95.0|-0.22|0.89||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.89|-0.22|0.237
72493895|NCT01978093|144516693|NON_INFERIORITY|Lower limit of the standardized asymptotic 95% CI for the difference (HibCY group minus the PedHIB group) in the percentage of subjects with anti-PRP concentrations ≥1.0 mg/mL is to be≥-10% (clinical limit for non-inferiority).|Difference in percentage of subjects|0.96|||||TWO_SIDED|95.0|-2.12|4.3|||Group difference in proportions|Before concluding on the primary objectives for Rotarix, Prevnar 13 and Havrix, this primary objective regarding anti-PRP needs to be reached||Difference between HibCY and PedHIB groups in percentage of subjects with anti-PRP concentrations equal to or above the cut-off value of 1.0 µg/mL one month after the fourth dose in HibCY Group and third dose in PedHIB Group.||4.30|-2.12|
72395073|NCT00720434|144296638|SUPERIORITY_OR_OTHER||Difference in Proportions|0.25|||||TWO_SIDED|95.0|-0.2913|0.696||||||Week 48: The difference in proportions between treatment groups presented along with 95% CI, were based on exact method for small samples from the binomial distribution.||0.6960|-0.2913|
72493896|NCT01978093|144516694|NON_INFERIORITY|Non-inferiority is concluded if lower limit of the two-sided standardized asymptotic 97.5% CI on the ratio of anti-rotavirus IgA GMC (HibCY group over PedHIB group) is to be ≥0.5|Adjusted GMC ratios|1.21|||||TWO_SIDED|97.5|0.77|1.9|||ANCOVA|GMC adjusted for BS sub-cohorts;97.5% confidence interval calculated for adjusted GMC ratio(Ancova model:adjustment for BS subcohorts-pooled variance)|To be able to conclude independently on primary objectives of Epoch 001(Rotarix \& Prevnar13 Post dose 3)\& Epoch 002 (Havrix \& Prevnar13 post dose 4),a Bonferroni correction is used in order to test these objectives(1.25% 1sided for Epoch 001 \& 002)|GMC ratios between HibCY and PedHIB groups for anti-Rota IgA concentrations 2 months after the second dose of Rotarix vaccine||1.90|0.77|
72493897|NCT01978093|144516695|NON_INFERIORITY|Lower limit of the two-sided 97.5% CI on the GMC ratio (HibCY group over PedHIB group) for antibodies to S. pneumoniae serotype 1 is to be ≥0.5 (clinical limit for non-inferiority).|Adjusted GMC ratio|1.18|||||TWO_SIDED|97.5|0.95|1.47|||ANCOVA|GMC adjusted for BS sub cohorts;97.5% CI for adjusted GMC ratio (Ancova Model: adjustment for BS sub cohorts-pooled variance)|To be able to conclude independently on primary objectives of Epoch 001(Rotarix \& Prevnar13 post dose 3)\& Epoch 002(Havrix \& Prevnar13 post dose 4),Bonferroni correction is used to test these primary objectives(1.25% 1sided for Epoch 001 \& Epoch 002)|GMC ratio between HibCY and PedHIB groups for antibodies to S. pneumoniae serotype 1 concentrations one month after the third dose.||1.47|0.95|
72493898|NCT01978093|144516695|NON_INFERIORITY|Lower limit of the two-sided 97.5% CI on the GMC ratio (HibCY group over PedHIB group) for antibodies to S. pneumoniae serotype 3 is to be≥0.5 (clinical limit for non-inferiority).|Adjusted GMC ratio|1.15|||||TWO_SIDED|97.5|0.93|1.42|||ANCOVA|GMC adjusted for BS subcohorts;97.5% CI for the adjusted GMC ratio(Ancova model:adjustment for BS subcohorts-pooled variance)|To be able to conclude independently on primary objectives of Epoch 001(Rotarix \& Prevnar13 post dose 3)\& Epoch 002(Havrix\&Prevnar13 post dose 4),a Bonferroni correction is used to test these primary objectives(1.25% 1sided for Epoch 001 \& Epoch 002)|GMC ratio between HibCY and PedHIB groups for antibodies to S. pneumoniae serotype 3 concentrations one month after the third dose.||1.42|0.93|
72493899|NCT01978093|144516695|NON_INFERIORITY|Lower limit of the two-sided 97.5% CI on the GMC ratio (HibCY group over PedHIB group) for antibodies to S. pneumoniae serotype 4 is to be≥ 0.5 (clinical limit for non-inferiority).|Adjusted GMC ratio|1.08|||||TWO_SIDED|97.5|0.9|1.31|||ANCOVA|GMC adjusted for BS subcohorts;97.5% CI for the adjusted GMC ratio(Ancova model:adjustment for BS subcohorts-pooled variance)|To be able to conclude independently on primary objectives of Epoch 001(Rotarix \& Prevnar13 post dose 3)\& Epoch 002(Havrix\&Prevnar13 post dose 4),a Bonferroni correction is used to test these primary objectives(1.25% 1sided for Epoch 001 \& Epoch 002)|GMC ratio between HibCY and PedHIB groups for antibodies to S. pneumoniae serotype 4 concentrations one month after the third dose.||1.31|0.90|
72493900|NCT01978093|144516695|NON_INFERIORITY|Lower limit of the two-sided 97.5% CI on the GMC ratio (HibCY group over PedHIB group) for antibodies to S. pneumoniae serotype 5 is to be ≥ 0.5 (clinical limit for non-inferiority).|Adjusted GMC ratio|1.18|||||TWO_SIDED|97.5|0.95|1.47|||ANCOVA|GMC adjusted for BS subcohorts;97.5% CI for the adjusted GMC ratio(Ancova model:adjustment for BS subcohorts-pooled variance)|To be able to conclude independently on primary objectives of Epoch 001(Rotarix \& Prevnar13 post dose 3)\& Epoch 002(Havrix\&Prevnar13 post dose 4),a Bonferroni correction is used to test these primary objectives(1.25% 1sided for Epoch 001 \& Epoch 002)|GMC ratio between HibCY and PedHIB groups for antibodies to S. pneumoniae serotype 5 concentrations one month after the third dose.||1.47|0.95|
72493901|NCT01978093|144516695|NON_INFERIORITY|Lower limit of the two-sided 97.5% CI on the GMC ratio (HibCY group over PedHIB group) for antibodies to S. pneumoniae serotype 6A is to be ≥0.5 (clinical limit for non-inferiority).|Adjusted GMC ratio|1.29|||||TWO_SIDED|97.5|1.03|1.63|||ANCOVA|GMC adjusted for BS subcohorts;97.5% CI for the adjusted GMC ratio(Ancova model:adjustment for BS subcohorts-pooled variance)|To be able to conclude independently on primary objectives of Epoch 001(Rotarix \& Prevnar13 post dose 3)\& Epoch 002(Havrix\&Prevnar13 post dose 4),a Bonferroni correction is used to test these primary objectives(1.25% 1sided for Epoch 001 \& Epoch 002)|GMC ratio between HibCY and PedHIB groups for antibodies to S. pneumoniae serotype 6A concentrations one month after the third dose.||1.63|1.03|
72493902|NCT01978093|144516695|NON_INFERIORITY|Lower limit of the two-sided 97.5% CI on the GMC ratio (HibCY group over PedHIB group) for antibodies to S. pneumoniae serotype 6B is to be≥0.5 (clinical limit for non-inferiority).|Adjusted GMC ratio|1.17|||||TWO_SIDED|97.5|0.88|1.55|||ANCOVA|GMC adjusted for BS subcohorts;97.5% CI for the adjusted GMC ratio(Ancova model:adjustment for BS subcohorts-pooled variance)|To be able to conclude independently on primary objectives of Epoch 001(Rotarix \& Prevnar13 post dose 3)\& Epoch 002(Havrix\&Prevnar13 post dose 4),a Bonferroni correction is used to test these primary objectives(1.25% 1sided for Epoch 001 \& Epoch 002)|GMC ratio between HibCY and PedHIB groups for antibodies to S. pneumoniae serotype 6B concentrations one month after the third dose.||1.55|0.88|
72493903|NCT01978093|144516695|NON_INFERIORITY|Lower limit of the two-sided 97.5% CI on the GMC ratio (HibCY group over PedHIB group) for antibodies to S. pneumoniae serotype 7F is to be≥0.5 (clinical limit for non-inferiority).|Adjusted GMC ratio|1.11|||||TWO_SIDED|97.5|0.91|1.34|||ANCOVA|GMC adjusted for BS subcohorts;97.5% CI for the adjusted GMC ratio(Ancova model:adjustment for BS subcohorts-pooled variance)|To be able to conclude independently on primary objectives of Epoch 001(Rotarix \& Prevnar13 post dose 3)\& Epoch 002(Havrix\&Prevnar13 post dose 4),a Bonferroni correction is used to test these primary objectives(1.25% 1sided for Epoch 001 \& Epoch 002)|GMC ratio between HibCY and PedHIB groups for antibodies to S. pneumoniae serotype 7F concentrations one month after the third dose.||1.34|0.91|
72504518|NCT02532543|144539771|SUPERIORITY|||||||0.863|||||||ANOVA|||||||0.863
72374621|NCT01947855|144259527|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-85.49|STANDARD_ERROR_OF_MEAN|20.18|<|0.0001|TWO_SIDED|95.0|-126.01|-44.97|||ANCOVA|Model includes treatment, number of previous antidiabetic medication, baseline renal function, baseline HbA1c and baseline AUC1-4h for plasma glucose.||Difference calculated as empa 10 mg minus placebo. The analyses will be performed sequentially compared with placebo from high dose of empagliflozin and the full significance level (5%) will be maintained by the hierarchical procedure.||-44.97|-126.01|<0.0001
72374622|NCT00821509|144259528|SUPERIORITY_OR_OTHER||ratio of proportions|1.03||||0.004|||||||proportion test|The test was carried out using the proportions calculated from the number of sick-leave episodes over the number o total follow-up weeks in each arm||According to the null hypothesis the proportion of weeks with an onset of days-off period in neither of the intervention arms was different from that of control. No in advance power calculations were done.||||0.004
72374623|NCT00821509|144259529|SUPERIORITY_OR_OTHER||ratio of proportions|0.933||||0.04|||||||proportion test|||According to the null hypothesis the proportion of weeks with an onset of an infectious disease period in neither of the intervention arms was different from that of control. No in advance power calculations were done.||||0.04
72374624|NCT03602560|144259535|OTHER|The primary endpoint was analyzed using Cochran-Mantel-Haenszel (CMH) test adjusted for both randomization stratification variables (ALP level: \<350 U/L and 2:350 U/L; pruritus NRS: \<4 and 2:4).|||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
72374625|NCT03602560|144259535|OTHER|The primary endpoint was analyzed using Cochran-Mantel-Haenszel (CMH) test adjusted for both randomization stratification variables (ALP level: \<350 U/L and 2:350 U/L; pruritus NRS: \<4 and 2:4).|||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
72374626|NCT03602560|144259536|OTHER|Two-sided p-value for each pair-wise comparison was based on the CMH test adjusted for both randomization stratification variables (ALP level: \<350 U/L and 350 U/L; pruritus NRS: \<4 and 4). Breslow-Day test was used to check the homogeneity of treatment effects across stratum.|||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
72374627|NCT03602560|144259536|OTHER|Two-sided p-value for each pair-wise comparison is based on the Cochran Mantel Haenszel test adjusted for both randomization stratification variables (ALP level: \< 350 U/L and \>= 350 U/L; pruritus NRS: \< 4 and \>= 4). Breslow-Day test is used to check the homogeneity of treatment effects across stratum.||||||0.0839|||||||Cochran-Mantel-Haenszel|||||||0.0839
72374628|NCT03602560|144259537|OTHER|"Change from baseline is estimated by an analysis of covariance (ANCOVA) model with treatment group (including 3 levels:~Placebo, Initial Dose 5mg, and Initial Dose 10 mg) and randomization ALP stratification as factors, and baseline as a covariate.~The p-value for the interaction between treatment and stratum is 0.7595, hence the interaction is dropped from the model."|Risk Difference (RD)|-1.59||||0.0164|TWO_SIDED|95.0|-2.87|-0.3|||ANCOVA|||||-0.3|-2.87|0.0164
72374629|NCT03602560|144259537|OTHER|"Change from baseline is estimated by an analysis of covariance (ANCOVA) model with treatment group (including 3 levels:~Placebo, Initial Dose 5mg, and Initial Dose 10 mg) and randomization ALP stratification as factors, and baseline as a covariate.~The p-value for the interaction between treatment and stratum is 0.7595, hence the interaction is dropped from the model."|Risk Difference (RD)|-0.46||||0.4781|TWO_SIDED|95.0|-1.77|0.84|||ANCOVA|||||0.84|-1.77|0.4781
72374630|NCT01588470|144259556|SUPERIORITY||||||<|0.01|||||||ANOVA|||||||<0.01
72374631|NCT01588470|144259558|SUPERIORITY||Mean Difference (Final Values)|-1.1|||<|0.05|TWO_SIDED||||||ANOVA|||||||<0.05
72374632|NCT03645434|144259559|SUPERIORITY||Mean Difference (Final Values)|0.202|||<|0.0001|TWO_SIDED|95.0|0.151|0.253|||Mixed Models Analysis|||||0.253|0.151|<0.0001
72374633|NCT03645434|144259564|SUPERIORITY||Mean Difference (Final Values)|0.098|||<|0.0001|TWO_SIDED|95.0|0.051|0.146|||Mixed Models Analysis|||Day 2||0.146|0.051|<0.0001
72374634|NCT03645434|144259564|SUPERIORITY||Mean Difference (Final Values)|0.195|||<|0.0001|TWO_SIDED|95.0|0.148|0.242|||Mixed Models Analysis|||Day 8||0.242|0.148|<0.0001
72374635|NCT03645434|144259565|SUPERIORITY||Mean Difference (Final Values)|0.306|||<|0.0001|TWO_SIDED|95.0|0.266|0.346|||Mixed Models Analysis|||Day 1||0.346|0.266|<0.0001
72493904|NCT01978093|144516695|NON_INFERIORITY|Lower limit of the two-sided 97.5% CI on the GMC ratio (HibCY group over PedHIB group) for antibodies to S. pneumoniae serotype 9V is to be≥0.5 (clinical limit for non-inferiority).|Adjusted GMC ratio|1.25|||||TWO_SIDED|97.5|1.0|1.55|||ANCOVA|GMC adjusted for BS subcohorts;97.5% CI for the adjusted GMC ratio(Ancova model:adjustment for BS subcohorts-pooled variance)|To be able to conclude independently on primary objectives of Epoch 001(Rotarix \& Prevnar13 post dose 3)\& Epoch 002(Havrix\&Prevnar13 post dose 4),a Bonferroni correction is used to test these primary objectives(1.25% 1sided for Epoch 001 \& Epoch 002)|GMC ratio between HibCY and PedHIB groups for antibodies to S. pneumoniae serotype 9V concentrations one month after the third dose.||1.55|1.00|
72504519|NCT02532543|144539772|SUPERIORITY|||||||0.718|||||||ANOVA|||Comparison between each arm/group at 2 mm from the height of the bone crest||||0.718
72374636|NCT03645434|144259565|SUPERIORITY||Mean Difference (Final Values)|0.374|||<|0.0001|TWO_SIDED|95.0|0.324|0.425|||Mixed Models Analysis|||Day 8||0.425|0.324|<0.0001
72374637|NCT03645434|144259565|SUPERIORITY||Mean Difference (Final Values)|0.388|||<|0.0001|TWO_SIDED|95.0|0.329|0.447|||Mixed Models Analysis|||Day 14||0.447|0.329|<0.0001
72374638|NCT03645434|144259566|SUPERIORITY||Mean Difference (Final Values)|-0.551||||0.001|TWO_SIDED|95.0|-0.876|-0.226|||Mixed Models Analysis|||Day 1 to Day 8||-0.226|-0.876|0.0010
72374639|NCT03645434|144259566|SUPERIORITY||Mean Difference (Final Values)|-0.867|||<|0.0001|TWO_SIDED|95.0|-1.248|-0.486|||Mixed Models Analysis|||Day 9 to Day 14||-0.486|-1.248|<0.0001
72374640|NCT03645434|144259566|SUPERIORITY||Mean Difference (Final Values)|-0.722|||<|0.0001|TWO_SIDED|95.0|-1.047|-0.397|||Mixed Models Analysis|||Day 1 to Day 14||-0.397|-1.047|<0.0001
72374641|NCT03645434|144259567|SUPERIORITY||Mean Difference (Final Values)|-1.571||||0.0022|TWO_SIDED|95.0|-2.563|-0.579|||Mixed Models Analysis|||Day 1 to Day 8||-0.579|-2.563|0.0022
72504520|NCT02532543|144539772|SUPERIORITY|||||||0.853|||||||ANOVA|||Comparison between each arm/group at 4 mm from the height of the bone crest||||0.853
72504521|NCT02532543|144539773|SUPERIORITY|||||||0.718|||||||ANOVA|||Comparison between each arm/group of change in mid buccal bone height||||0.718
72374642|NCT03645434|144259567|SUPERIORITY||Mean Difference (Final Values)|-2.386|||<|0.0001|TWO_SIDED|95.0|-3.541|-1.23|||Mixed Models Analysis|||Day 9 to Day 14||-1.230|-3.541|<0.0001
72374643|NCT03645434|144259567|SUPERIORITY||Mean Difference (Final Values)|-1.912||||0.0003|TWO_SIDED|95.0|-2.923|-0.901|||Mixed Models Analysis|||Day 1 to Day 14||-0.901|-2.923|0.0003
72374644|NCT03645434|144259578|SUPERIORITY||Mean Difference (Final Values)|-1.268|||<|0.0001|TWO_SIDED|95.0|-1.741|-0.794|||Mixed Models Analysis|||Day 1 to Day 8||-0.794|-1.741|<0.0001
72374645|NCT03645434|144259578|SUPERIORITY||Mean Difference (Final Values)|-1.302|||<|0.0001|TWO_SIDED|95.0|-1.804|-0.8|||Mixed Models Analysis|||Day 9 to Day 14||-0.800|-1.804|<0.0001
72374646|NCT00833664|144259579|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Test/Ref Ratio of LS Means x 100|98.2||||||90.0|88.1|109.5|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||109.5|88.1|
72374647|NCT00833664|144259580|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Test/Ref Ratio of LS Means x 100|107.6||||||90.0|104.7|110.6|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||110.6|104.7|
72374648|NCT00833664|144259581|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Test/Ref Ratio of LS Means x 100|98.2||||||90.0|92.7|104.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||104.0|92.7|
72374649|NCT02204124|144259599|SUPERIORITY|||||||0.032|||||||Wilcoxon (Mann-Whitney)|||||||0.032
72374650|NCT02204124|144259600|SUPERIORITY|||||||0.513|||||||Chi-squared|||||||0.513
72374651|NCT02204124|144259603|SUPERIORITY|||||||0.013|||||||Wilcoxon (Mann-Whitney)|||||||0.013
72374652|NCT02204124|144259604|SUPERIORITY|||||||0.132|||||||Chi-squared|||||||0.132
72374653|NCT02204124|144259605|SUPERIORITY|||||||0.975|||||||Chi-squared|||Statistical analysis #1 is for readmission||||0.975
72374654|NCT02204124|144259605|SUPERIORITY|||||||0.401|||||||Chi-squared|||Statistical analysis #2 is for wound infection.||||0.401
72374655|NCT02204124|144259605|SUPERIORITY|||||||0.975|||||||Chi-squared|||Statistical analysis #3 is for gastroparesis.||||0.975
72493905|NCT01978093|144516695|NON_INFERIORITY|Lower limit of the two-sided 97.5% CI on the GMC ratio (HibCY group over PedHIB group) for antibodies to S. pneumoniae serotype 14 is to be≥0.5 (clinical limit for non-inferiority).|Adjusted GMC ratio|1.16|||||TWO_SIDED|97.5|0.9|1.5|||ANCOVA|GMC adjusted for BS subcohorts;97.5% CI for the adjusted GMC ratio(Ancova model:adjustment for BS subcohorts-pooled variance)|To be able to conclude independently on primary objectives of Epoch 001(Rotarix \& Prevnar13 post dose 3)\& Epoch 002(Havrix\&Prevnar13 post dose 4),a Bonferroni correction is used to test these primary objectives(1.25% 1sided for Epoch 001 \& Epoch 002)|GMC ratio between HibCY and PedHIB groups for antibodies to S. pneumoniae serotype 14 concentrations one month after the third dose.||1.50|0.90|
72504522|NCT02532543|144539773|SUPERIORITY|||||||0.999|||||||ANOVA|||Comparison between each arm/group of change in mid palatal bone height||||0.999
72504523|NCT02532543|144539773|SUPERIORITY|||||||0.44|||||||ANOVA|||Comparison between each arm/group of change in mesial bone height||||0.440
72374656|NCT02204124|144259605|SUPERIORITY|||||||0.401|||||||Chi-squared|||Statistical analysis #4 is for pancreatic fistula.||||0.401
72374657|NCT02204124|144259605|SUPERIORITY|||||||0.219|||||||Chi-squared|||Statistical analysis #5 is for intraabdominal abscess.||||0.219
72374658|NCT02204124|144259605|SUPERIORITY|||||||0.401|||||||Chi-squared|||Statistical analysis #6 is for anastomotic leakage.||||0.401
72374659|NCT02204124|144259605|SUPERIORITY|||||||0.219|||||||Chi-squared|||Statistical analysis #7 is for blood product transfusion (anemia).||||0.219
72374660|NCT00594425|144259632|SUPERIORITY_OR_OTHER||% success rate|5.53||||0.5288|TWO_SIDED|95.0|-7.97|19.04||Priori threshold for statistical significance was 5%|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by center. No adjustment for multiple comparisons was done||H0: τ (Vehicle PDT) = τ (MAL PDT) versus HA: τ (Vehicle PDT) ≠ τ (MAL PDT)||19.04|-7.97|0.5288
72374661|NCT00594425|144259632|SUPERIORITY_OR_OTHER||% success rate|3.95||||0.7539|TWO_SIDED|95.0|-8.79|16.69||Priori threshold for statistical significance was 5%|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by center. No adjustment for multiple comparisons was done||H0: τ (Vehicle PDT) = τ (MAL PDT) versus HA: τ (Vehicle PDT) ≠ τ (MAL PDT)||16.69|-8.79|0.7539
72374662|NCT00594425|144259633|SUPERIORITY_OR_OTHER||Least squares mean|-2.64||||0.3236|TWO_SIDED|95.0|-7.91|2.63||Priori threshold for statistical significance was 5%|ANCOVA|ANCOVA model including center and baseline lesion count as a covariates. No adjustment for multiple comparisons was done||H0: τ (Vehicle PDT) = τ (MAL PDT) versus HA: τ (Vehicle PDT) ≠ τ (MAL PDT)||2.63|-7.91|0.3236
72374663|NCT00594425|144259633|SUPERIORITY_OR_OTHER||Least squares mean|-1.19||||0.6657|TWO_SIDED|95.0|-6.64|4.26||Priori threshold for statistical significance was 5%|ANCOVA|ANCOVA model including center and baseline lesion count as a covariates. No adjustment for multiple comparisons was done||H0: τ (Vehicle PDT) = τ (MAL PDT) versus HA: τ (Vehicle PDT) ≠ τ (MAL PDT)||4.26|-6.64|0.6657
72374664|NCT00594425|144259661|SUPERIORITY_OR_OTHER||%success rate|3.09||||0.7889|TWO_SIDED|95.0|-11.16|17.33||Priori threshold for statistical significance was 5%|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel stratified by center. No adjustment for multiple comparisons was done||H0: τ (Vehicle PDT) = τ (MAL PDT) versus HA: τ (Vehicle PDT) ≠ τ (MAL PDT)||17.33|-11.16|0.7889
72374665|NCT00594425|144259661|SUPERIORITY_OR_OTHER||Percent success|5.48||||0.888|TWO_SIDED|95.0|-10.15|21.11||Priori threshold for statistical significance was 5%|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test stratified by center. No adjustment for multiple comparisons was done||H0: τ (Vehicle PDT) = τ (MAL PDT) versus HA: τ (Vehicle PDT) ≠ τ (MAL PDT)||21.11|-10.15|0.8880
72374666|NCT00594425|144259662|SUPERIORITY_OR_OTHER||Least squares mean|-0.33||||0.9151|TWO_SIDED|95.0|-6.53|5.86||Priori threshold for statistical significance was 5%|ANCOVA|ANCOVA model including center and baseline lesion count as a covariates. No adjustment for multiple comparisons was done||H0: τ (Vehicle PDT) = τ (MAL PDT) versus HA: τ (Vehicle PDT) ≠ τ (MAL PDT)||5.86|-6.53|0.9151
72374667|NCT00594425|144259662|SUPERIORITY_OR_OTHER||Least squares mean|-1.18||||0.7233|TWO_SIDED|95.0|-7.81|5.45||Priori threshold for statistical significance was 5%|ANCOVA|ANCOVA model including center and baseline lesion count as a covariates. No adjustment for multiple comparisons was done||H0: τ (Vehicle PDT) = τ (MAL PDT) versus HA: τ (Vehicle PDT) ≠ τ (MAL PDT)||5.45|-7.81|0.7233
72504524|NCT02532543|144539773|SUPERIORITY|||||||0.729|||||||ANOVA|||Comparison between each arm/group of change in distal bone height||||0.729
72504525|NCT02532543|144539774|SUPERIORITY|||||||0.613|||||||ANOVA|||||||0.613
72504526|NCT02532543|144539775|SUPERIORITY|||||||0.492|||||||ANOVA|||Comparison between each arm/group at 2 mm from the height of the bone crest||||0.492
72504527|NCT02532543|144539775|SUPERIORITY|||||||0.917|||||||ANOVA|||Comparison between each arm/group at 4 mm from the height of the bone crest||||0.917
72374668|NCT01122264|144259664|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.66|||<|0.001|TWO_SIDED|97.3|0.51|0.85||P-value: Tadalafil Once a Day versus Sildenafil Citrate On Demand treatment groups. Cox's proportional hazards model with factors for randomized treatment group, baseline International Index of Erectile Function-Erectile Function score, and country.|Regression, Cox|||||0.85|0.51|<0.001
72374669|NCT01122264|144259664|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.49|||<|0.001|TWO_SIDED|97.3|0.37|0.65||P-value: Tadalafil On Demand versus Sildenafil Citrate On Demand treatment groups. Cox's proportional hazards model with factors for randomized treatment group, baseline International Index of Erectile Function-Erectile Function score, and country.|Regression, Cox|||||0.65|0.37|<0.001
72374670|NCT01122264|144259664|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.32||||0.033|TWO_SIDED|95.0|1.02|1.71||P-value: Tadalafil On Demand versus Tadalafil Once a Day treatment groups using Cox's proportional hazards model with factors for randomized treatment group, baseline International Index of Erectile Function-Erectile Function score, and country.|Regression, Cox|||||1.71|1.02|0.033
72374671|NCT01323855|144259780|NON_INFERIORITY_OR_EQUIVALENCE|Geometric Mean Ratio (GMR) is contained within the interval \[0.50, 2.00\]|GMR|1.19|||||TWO_SIDED|90.0|0.54|2.62|||||Severe CRI/Healthy|||2.62|0.54|
72374672|NCT01323855|144259781|NON_INFERIORITY_OR_EQUIVALENCE|GMR is contained within the interval \[0.50, 2.00\]|GMR|1.3|||||TWO_SIDED|90.0|0.59|2.87|||||Moderate CRI/Healthy|||2.87|0.59|
72374673|NCT01323855|144259782|NON_INFERIORITY_OR_EQUIVALENCE|GMR is contained within the interval \[0.50, 2.00\]|GMR|2.63|||||TWO_SIDED|90.0|1.38|5.04|||||Mild CRI/Healthy|||5.04|1.38|
72374674|NCT02683746|144259842|NON_INFERIORITY|The primary hypothesis tested was that the liquid drug product would provide glycemic control non-inferior to the lyophilized drug product for a period of 26 weeks of treatment in participants with T2DM. Non-inferiority testing was performed at a one-sided alpha of 0.025 and non-inferiority margin of 0.4.|Mean Difference (Net)|0.06||||0.0002|TWO_SIDED|95.0|-0.13|0.24||P-value from a one-sided t-test to test whether the difference of least square means (Albiglutide liquid - Albiglutide lyophilized) is equal to the pre-specified non-inferiority margin of 0.4%.|MMRM model|||||0.24|-0.13|0.0002
72374675|NCT02683746|144259850|OTHER||Mean Difference (Net)|-0.34|||||TWO_SIDED|95.0|-0.83|0.14||||||||0.14|-0.83|
72374676|NCT02683746|144259851|OTHER||Mean Difference (Net)|0.03|||<|0.0001|TWO_SIDED|95.0|-0.07|0.13||Calculated P-value from a one-sided t-test to test whether the difference of least square means (Albiglutide liquid - Albiglutide lyophilized) is equal to the pre-specified non-inferiority margin of 0.4%.|MMRM model||Difference in HbA1c levels between albiglutide liquid and lyophilized product at Week 4 are presented.|||0.13|-0.07|<0.0001
72374677|NCT02683746|144259851|OTHER||Mean Difference (Net)|0.07|||<|0.0001|TWO_SIDED|95.0|-0.07|0.2||Calculated P-value from a one-sided t-test to test whether the difference of least square means (Albiglutide liquid - Albiglutide lyophilized) is equal to the pre-specified non-inferiority margin of 0.4%.|MMRM model||Difference in HbA1c levels between albiglutide liquid and lyophilized product at Week 8 are presented.|||0.20|-0.07|<0.0001
72374678|NCT02683746|144259851|OTHER||Mean Difference (Net)|0.08|||<|0.0001|TWO_SIDED|95.0|-0.08|0.24||Calculated P-value from a one-sided t-test to test whether the difference of least square means (Albiglutide liquid - Albiglutide lyophilized) is equal to the pre-specified non-inferiority margin of 0.4%.|MMRM model||Difference in HbA1c levels between albiglutide liquid and lyophilized product at Week 12 are presented.|||0.24|-0.08|<0.0001
72374679|NCT02683746|144259851|OTHER||Mean Difference (Net)|0.02|||<|0.0001|TWO_SIDED|95.0|-0.16|0.2||Calculated P-value from a one-sided t-test to test whether the difference of least square means (Albiglutide liquid - Albiglutide lyophilized) is equal to the pre-specified non-inferiority margin of 0.4%.|MMRM model||Difference in HbA1c levels between albiglutide liquid and lyophilized product at Week 16 are presented.|||0.20|-0.16|<0.0001
72374680|NCT02683746|144259851|OTHER||Mean Difference (Net)|0.02|||<|0.0001|TWO_SIDED|95.0|-0.15|0.19||Calculated P-value from a one-sided t-test to test whether the difference of least square means (Albiglutide liquid - Albiglutide lyophilized) is equal to the pre-specified non-inferiority margin of 0.4%.|MMRM model||Difference in HbA1c levels between albiglutide liquid and lyophilized product at Week 20 are presented.|||0.19|-0.15|<0.0001
72374681|NCT02683746|144259851|OTHER||Mean Difference (Net)|0.01|||<|0.0001|TWO_SIDED|95.0|-0.17|0.2||Calculated P-value from a one-sided t-test to test whether the difference of least square means (Albiglutide liquid - Albiglutide lyophilized) is equal to the pre-specified non-inferiority margin of 0.4%.|MMRM model||Difference in HbA1c levels between albiglutide liquid and lyophilized product at Week 26 are presented.|||0.20|-0.17|<0.0001
72374682|NCT02683746|144259852|OTHER||Mean Difference (Net)|0.25|||||TWO_SIDED|95.0|-0.15|0.65|||||Difference in FPG levels between albiglutide liquid and lyophilized product at Week 1 are presented.|||0.65|-0.15|
72374683|NCT02683746|144259852|OTHER||Mean Difference (Net)|0.25|||||TWO_SIDED|95.0|-0.2|0.69|||||Difference in FPG levels between albiglutide liquid and lyophilized product at Week 2 are presented.|||0.69|-0.20|
72374684|NCT02683746|144259852|OTHER||Mean Difference (Net)|-0.01|||||TWO_SIDED|95.0|-0.42|0.4|||||Difference in FPG levels between albiglutide liquid and lyophilized product at Week 3 are presented.|||0.40|-0.42|
72374685|NCT02683746|144259852|OTHER||Mean Difference (Net)|-0.03|||||TWO_SIDED|95.0|-0.42|0.36|||||Difference in FPG levels between albiglutide liquid and lyophilized product at Week 4 are presented.|||0.36|-0.42|
72374686|NCT02683746|144259852|OTHER||Mean Difference (Net)|0.19|||||TWO_SIDED|95.0|-0.19|0.57|||||Difference in FPG levels between albiglutide liquid and lyophilized product at Week 5 are presented.|||0.57|-0.19|
72374687|NCT02683746|144259852|OTHER||Mean Difference (Net)|0.15|||||TWO_SIDED|95.0|-0.26|0.55|||||Difference in FPG levels between albiglutide liquid and lyophilized product at Week 6 are presented.|||0.55|-0.26|
72374688|NCT02683746|144259852|OTHER||Mean Difference (Net)|0.27|||||TWO_SIDED|95.0|-0.16|0.71|||||Difference in FPG levels between albiglutide liquid and lyophilized product at Week 7 are presented.|||0.71|-0.16|
72374689|NCT02683746|144259852|OTHER||Mean Difference (Net)|0.19|||||TWO_SIDED|95.0|-0.22|0.6|||||Difference in FPG levels between albiglutide liquid and lyophilized product at Week 8 are presented.|||0.60|-0.22|
72374690|NCT02683746|144259852|OTHER||Mean Difference (Net)|0.03|||||TWO_SIDED|95.0|-0.41|0.47|||||Difference in FPG levels between albiglutide liquid and lyophilized product at Week 9 are presented.|||0.47|-0.41|
72374691|NCT02683746|144259852|OTHER||Mean Difference (Net)|0.15|||||TWO_SIDED|95.0|-0.28|0.57|||||Difference in FPG levels between albiglutide liquid and lyophilized product at Week 10 are presented.|||0.57|-0.28|
72374692|NCT02683746|144259852|OTHER||Mean Difference (Net)|0.11|||||TWO_SIDED|95.0|-0.34|0.56|||||Difference in FPG levels between albiglutide liquid and lyophilized product at Week 11 are presented.|||0.56|-0.34|
72374693|NCT02683746|144259852|OTHER||Mean Difference (Net)|0.03|||||TWO_SIDED|95.0|-0.41|0.46|||||Difference in FPG levels between albiglutide liquid and lyophilized product at Week 12 are presented.|||0.46|-0.41|
72374694|NCT02683746|144259852|OTHER||Mean Difference (Net)|0.05|||||TWO_SIDED|95.0|-0.47|0.57|||||Difference in FPG levels between albiglutide liquid and lyophilized product at Week 13 are presented.|||0.57|-0.47|
72374695|NCT02683746|144259852|OTHER||Mean Difference (Net)|0.06|||||TWO_SIDED|95.0|-0.41|0.54|||||Difference in FPG levels between albiglutide liquid and lyophilized product at Week 16 are presented.|||0.54|-0.41|
72374696|NCT02683746|144259852|OTHER||Mean Difference (Net)|0.03|||||TWO_SIDED|95.0|-0.47|0.53|||||Difference in FPG levels between albiglutide liquid and lyophilized product at Week 20 are presented.|||0.53|-0.47|
72374697|NCT02683746|144259852|OTHER||Mean Difference (Net)|-0.34|||||TWO_SIDED|95.0|-0.83|0.14|||||Difference in FPG levels between albiglutide liquid and lyophilized product at Week 26 are presented.|||0.14|-0.83|
72374698|NCT04987944|144259854|OTHER||Least square mean difference|-9.8|||||TWO_SIDED|95.0|-24.5|5.0||||||||5.0|-24.5|
72374699|NCT04987944|144259855|OTHER||Least square mean difference|-3.9|||||TWO_SIDED|95.0|-19.4|11.5||||||||11.5|-19.4|
72555696|NCT02558491|144642698|OTHER|||||||0.824||||||No a priori sample size was determined due to the feasibility/pilot nature of the trial. Significance level was set at P-value \<0.05.|ANOVA|||Secondary analysis followed the same format unless variables could not be considered normally distributed; in that case a related samples Wilcoxon signed-rank test is used. Data were first binned (to ensure minimum count of five per bins) and the w2 statistics was used with the expected counts given by SoC. Based on achieved recruitment, a moderate effect size (0.3) is detectable with 80% power, or a large effect size (0.4) with 95% power (G-Power 3.1.9.2). Outcome measurement was for overnight.||||0.824
72374700|NCT04987944|144259856|OTHER||Least square mean difference|0.423|||||TWO_SIDED|95.0|-0.125|0.972||||||||0.972|-0.125|
72374701|NCT00345332|144259859|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||ANOVA|||||||<0.01
72374702|NCT00345332|144259860|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||ANOVA|||||||<0.01
72374703|NCT04121078|144259872|EQUIVALENCE|Point estimate and its 90% confidence interval (CI) were calculated for Treatment B to Treatment A ratio of geometric means for Cmax based on the mixed-effect model of log-transformed Cmax with sequence, treatment, and period as fixed effects, and participant nested within sequence as a random effect. Bioequivalence was concluded if the 90% CI for the ratio of geometric means is entirely contained within 80% to 125% for Cmax. No adjustments were made for multiplicity.|Geometric Mean Ratio|6.24|||||TWO_SIDED|90.0|4.62|8.42||||||||8.42|4.62|
72374704|NCT04121078|144259873|EQUIVALENCE|Point estimate and its 90% CI were calculated for Treatment B to Treatment A ratio of geometric means for AUC∞ based on the mixed-effect model of log-transformed AUC∞ with sequence, treatment, and period as fixed effects, and participant nested within sequence as a random effect. Bioequivalence was concluded if the 90% CI for the ratio of geometric means is entirely contained within 80% to 125% for AUC∞. No adjustments were made for multiplicity.|Geometric Mean Ratio|5.16|||||TWO_SIDED|90.0|4.25|6.25||||||||6.25|4.25|
72374705|NCT04121078|144259874|EQUIVALENCE|Point estimate and its 90% CI were calculated for Treatment B to Treatment A ratio of geometric means for AUClast based on the mixed-effect model of log-transformed AUClast with sequence, treatment, and period as fixed effects, and participant nested within sequence as a random effect. Bioequivalence was concluded if the 90% CI for the ratio of geometric means is entirely contained within 80% to 125% for AUClast. No adjustments were made for multiplicity.|Geometric Mean Ratio|5.21|||||TWO_SIDED|90.0|4.29|6.32||||||||6.32|4.29|
72374706|NCT02012582|144259936|SUPERIORITY_OR_OTHER||||||<|0.04|TWO_SIDED|||||Mixed model analysis for TIL with the patient as random effect and study day, cohort, treatment, and interaction between study day and treatment as fixed effects.|Mixed Models Analysis|||Placebo versus pooled VAS203 Arms/Groups||||<0.04
72374707|NCT02012582|144259937|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||Kruskal-Wallis|||Placebo versus pooled VAS203 Arms/Group||||<0.01
72374708|NCT04740905|144259942|NON_INFERIORITY|If the lower bound of a two-sided 95% confidence interval (CI) for the difference in adjusted means of the two treatments (faricimab minus aflibercept) is greater than -4 letters (the non-inferiority margin), then faricimab is considered non-inferior to aflibercept.|Difference in Adjusted Means|-0.6|STANDARD_ERROR_OF_MEAN|0.84|||TWO_SIDED|95.0|-2.2|1.1|||||The treatment difference in adjusted means of change from baseline BCVA is the calculated difference of Arm A: Faricimab and Arm B: Aflibercept. MMRM adjustments are listed in the outcome measure description.|The null hypothesis, H0: μ(faricimab) - μ(aflibercept) ≤-4 letters; the alternative hypothesis, Ha: μ(faricimab) - μ(aflibercept) \>-4 letters. The final sample size provided \>90% power for the non-inferiority assessment (at a one-sided 0.02485 significance level).||1.1|-2.2|
72374709|NCT04740905|144259942|SUPERIORITY||Difference in Adjusted Means|-0.6|STANDARD_ERROR_OF_MEAN|0.84||0.4978|TWO_SIDED|95.0|-2.2|1.1||Tested at a two-sided 0.0497 significance level.|Mixed Model of Repeated Measures||The treatment difference in adjusted means of change from baseline BCVA is the calculated difference of Arm A: Faricimab and Arm B: Aflibercept. MMRM adjustments are listed in the outcome measure description.|The final sample size provided \>80% power for a 3.5-letter superiority assessment of faricimab over aflibercept.||1.1|-2.2|0.4978
72374710|NCT04740905|144259944|OTHER||Difference in CMH Weighted Percentage|-4.3|||||TWO_SIDED|95.0|-12.3|3.8||||||||3.8|-12.3|
72374711|NCT04740905|144259960|OTHER||Difference in Adjusted Means|-0.4|STANDARD_ERROR_OF_MEAN|0.76|||TWO_SIDED|95.0|-1.9|1.1||||||||1.1|-1.9|
72374712|NCT02700334|144259998|OTHER|||||||0.005|||||||Wilcoxon (Mann-Whitney)|||||||0.005
72374713|NCT02700334|144259999|OTHER|||||||0.093|||||||Wilcoxon (Mann-Whitney)|||||||0.093
72374714|NCT02700334|144260000|OTHER|||||||0.878|||||||Wilcoxon (Mann-Whitney)|||||||0.878
72374715|NCT02700334|144260001|OTHER|||||||0.959|||||||Wilcoxon (Mann-Whitney)|||||||0.959
72374716|NCT02700334|144260002|OTHER|||||||0.005|||||||Wilcoxon (Mann-Whitney)|||||||0.005
72374717|NCT02700334|144260003|OTHER|||||||0.331|||||||Wilcoxon (Mann-Whitney)|||||||0.331
72374718|NCT02700334|144260004|OTHER|||||||0.005|||||||Wilcoxon (Mann-Whitney)|||||||0.005
72374719|NCT02700334|144260005|OTHER|||||||0.005|||||||Wilcoxon (Mann-Whitney)|||||||0.005
72374720|NCT02700334|144260006|OTHER|||||||0.575|||||||Wilcoxon (Mann-Whitney)|||||||0.575
72374721|NCT02700334|144260007|OTHER|||||||0.314|||||||Wilcoxon (Mann-Whitney)|||||||0.314
72374722|NCT02700334|144260008|OTHER|||||||0.721|||||||Wilcoxon (Mann-Whitney)|||||||0.721
72374723|NCT02700334|144260009|OTHER|||||||0.066|||||||Wilcoxon (Mann-Whitney)|||||||0.066
72374724|NCT02700334|144260010|OTHER|||||||0.333|||||||Wilcoxon (Mann-Whitney)|||||||0.333
72374725|NCT02700334|144260011|OTHER|||||||0.859|||||||Wilcoxon (Mann-Whitney)|||||||0.859
72374726|NCT02700334|144260012|OTHER|||||||0.009|||||||Wilcoxon (Mann-Whitney)|||||||0.009
72374727|NCT02700334|144260013|OTHER|||||||0.919|||||||Wilcoxon (Mann-Whitney)|||||||0.919
72374728|NCT02700334|144260014|OTHER|||||||0.72|||||||Wilcoxon (Mann-Whitney)|||||||0.720
72374729|NCT02412488|144260019|OTHER|"The goal of the primary study objective was to estimate the rate of untoward events associated with Reveal LINQ insertions performed in the out-of-cathlab setting through 3-months within a desired level of precision. The target sample size of approximately 200 subjects undergoing Reveal LINQ insertion was selected to ensure that the upper 95% confidence interval would be within 3 percentage points of the point estimate of the untoward event rate assuming the underlying rate was 2%"|Event Rate expressed as a percent|0.0|||||TWO_SIDED|95.0|0.0|2.1|||||The estimate is the observed rate of untoward events expressed as a percentage. The 95% confidence interval is also expressed as a percentage|"There was no formal statistical hypothesis test associated with the primary outcome measure. Rather the goal of the primary study objective was to estimate the rate of untoward events associated with Reveal LINQ insertions performed in the out-of-cathlab setting through 3-months within a desired level of precision."||2.1|0|
72374730|NCT03222492|144260034|SUPERIORITY|||||||1||||||P-value is from comparing the number of participants with the AEs of interest between the two treatment groups using Fisher's exact test.|Fisher Exact|||Treatment start to Week 48||||1.000
72374731|NCT03222492|144260034|SUPERIORITY|||||||0.444||||||P-value is from comparing the number of participants with the AEs of interest between the two treatment groups using Fisher's exact test.|Fisher Exact|||Treatment start to Week 48||||0.444
72504528|NCT02532543|144539776|SUPERIORITY|||||||0.353|||||||ANOVA|||Comparison between each arm/group of change in mid buccal soft tissue height||||0.353
72374732|NCT03222492|144260035|SUPERIORITY|||||||1||||||P-value is from comparing the number of participants with the AEs of interest between the two treatment groups using Fisher's exact test.|Fisher Exact|||Treatment start to Week 48||||1.000
72374733|NCT03222492|144260035|SUPERIORITY|||||||0.4||||||P-value is from comparing the number of participants with the AEs of interest between the two treatment groups using Fisher's exact test.|Fisher Exact|||Treatment start to Week 48||||0.400
72374734|NCT03222492|144260036|SUPERIORITY|||||||1||||||P-value is from comparing the number of participants with the AEs of interest between the two treatment groups using Fisher's exact test.|Fisher Exact|||Treatment start to Week 12||||1.000
72374735|NCT03222492|144260036|SUPERIORITY|||||||1||||||P-value is from comparing the number of participants with the AEs of interest between the two treatment groups using Fisher's exact test.|Fisher Exact|||Treatment start to Week 12||||1.000
72374736|NCT03222492|144260036|SUPERIORITY|||||||1||||||P-value is from comparing the number of participants with the AEs of interest between the two treatment groups using Fisher's exact test.|Fisher Exact|||Treatment start to Week 24||||1.000
72374737|NCT03222492|144260036|SUPERIORITY|||||||1||||||P-value is from comparing the number of participants with the AEs of interest between the two treatment groups using Fisher's exact test.|Fisher Exact|||Treatment start to Week 24||||1.000
72374738|NCT03222492|144260036|SUPERIORITY|||||||1||||||P-value is from comparing the number of participants with the AEs of interest between the two treatment groups using Fisher's exact test.|Fisher Exact|||Treatment start to Week 36||||1.000
72374739|NCT03222492|144260036|SUPERIORITY|||||||0.5||||||P-value is from comparing the number of participants with the AEs of interest between the two treatment groups using Fisher's exact test.|Fisher Exact|||Treatment start to Week 36||||0.500
72374740|NCT03222492|144260037|SUPERIORITY|||||||1||||||P-value is from comparing the number of participants with the AEs of interest between the two treatment groups using Fisher's exact test.|Fisher Exact|||Treatment start to Week 12||||1.000
72374741|NCT03222492|144260037|SUPERIORITY|||||||1||||||P-value is from comparing the number of participants with the AEs of interest between the two treatment groups using Fisher's exact test.|Fisher Exact|||Treatment start to Week 12||||1.000
72374742|NCT03222492|144260038|SUPERIORITY|||||||1||||||P-value is from comparing the number of participants with the AEs of interest between the two treatment groups using Fisher's exact test.|Fisher Exact|||Treatment start to Week 24||||1.000
72374743|NCT03222492|144260038|SUPERIORITY|||||||0.467||||||P-value is from comparing the number of participants with the AEs of interest between the two treatment groups using Fisher's exact test.|Fisher Exact|||Treatment start to Week 24||||0.467
72374744|NCT03222492|144260039|SUPERIORITY|||||||1||||||P-value is from comparing the number of participants with the AEs of interest between the two treatment groups using Fisher's exact test.|Fisher Exact|||Treatment start to Week 36||||1.000
72374745|NCT03222492|144260039|SUPERIORITY|||||||0.4||||||P-value is from comparing the number of participants with the AEs of interest between the two treatment groups using Fisher's exact test.|Fisher Exact|||Treatment start to Week 36||||0.400
72374746|NCT03222492|144260040|SUPERIORITY|||||||0.464||||||P-value is from comparing the number of participants with the AEs of interest between the two treatment groups using Fisher's exact test.|Fisher Exact|||Treatment start to Week 12||||0.464
72374747|NCT03222492|144260040|SUPERIORITY|||||||0.5||||||P-value is from comparing the number of participants with the AEs of interest between the two treatment groups using Fisher's exact test.|Fisher Exact|||Treatment start to Week 12||||0.500
72374748|NCT03222492|144260040|SUPERIORITY|||||||0.25||||||P-value is from comparing the number of participants with the AEs of interest between the two treatment groups using Fisher's exact test.|Fisher Exact|||Treatment start to Week 24||||0.250
72504529|NCT02532543|144539776|SUPERIORITY|||||||0.823|||||||ANOVA|||Comparison between each arm/group of change in mid palatal soft tissue height||||0.823
72504530|NCT02532543|144539776|SUPERIORITY|||||||0.243|||||||ANOVA|||Comparison between each arm/group of change in mesial soft tissue height||||0.243
72504531|NCT02532543|144539776|SUPERIORITY|||||||0.756|||||||ANOVA|||Comparison between each arm/group of change in distal soft tissue height||||0.756
72374749|NCT03222492|144260040|SUPERIORITY|||||||0.167||||||P-value is from comparing the number of participants with the AEs of interest between the two treatment groups using Fisher's exact test.|Fisher Exact|||Treatment start to Week 24||||0.167
72374750|NCT03222492|144260040|SUPERIORITY|||||||0.083||||||P-value is from comparing the number of participants with the AEs of interest between the two treatment groups using Fisher's exact test.|Fisher Exact|||Treatment start to Week 36||||0.083
72374751|NCT03222492|144260040|SUPERIORITY|||||||0.083||||||P-value is from comparing the number of participants with the AEs of interest between the two treatment groups using Fisher's exact test.|Fisher Exact|||Treatment start to Week 48||||0.083
72374752|NCT03222492|144260041|SUPERIORITY|||||||1||||||P-value is from comparing the number of participants with the AEs of interest between the two treatment groups using Fisher's exact test.|Fisher Exact|||Treatment start to Week 12||||1.000
72374753|NCT03222492|144260041|SUPERIORITY|||||||0.429||||||P-value is from comparing the number of participants with the AEs of interest between the two treatment groups using Fisher's exact test.|Fisher Exact|||Treatment start to Week 12||||0.429
72374754|NCT03222492|144260042|SUPERIORITY|||||||0.286||||||P-value is from comparing the number of participants with the AEs of interest between the two treatment groups using Fisher's exact test.|Fisher Exact|||Treatment start to Week 24||||0.286
72374755|NCT03222492|144260042|SUPERIORITY|||||||0.067||||||P-value is from comparing the number of participants with the AEs of interest between the two treatment groups using Fisher's exact test.|Fisher Exact|||Treatment start to Week 24||||0.067
72374756|NCT03222492|144260043|SUPERIORITY|||||||0.1||||||P-value is from comparing the number of participants with the AEs of interest between the two treatment groups using Fisher's exact test.|Fisher Exact|||Treatment start to Week 36||||0.100
72374757|NCT03222492|144260044|SUPERIORITY|||||||0.1||||||P-value is from comparing the number of participants with the AEs of interest between the two treatment groups using Fisher's exact test.|Fisher Exact|||Treatment start to Week 48||||0.100
72374758|NCT03222492|144260055|SUPERIORITY|||||||1||||||P-value is from comparing the number of participants with the AEs of interest between the two treatment groups using Fisher's exact test.|Fisher Exact|||Treatment start to Week 48||||1.000
72374759|NCT03222492|144260055|SUPERIORITY|||||||1||||||P-value is from comparing the number of participants with the AEs of interest between the two treatment groups using Fisher's exact test.|Fisher Exact|||Treatment start to Week 48||||1.000
72374760|NCT03222492|144260056|SUPERIORITY|||||||1||||||P-value is from comparing the number of participants with the AEs of interest between the two treatment groups using Fisher's exact test.|Fisher Exact|||||||1.000
72374761|NCT03222492|144260056|SUPERIORITY|||||||1||||||P-value is from comparing the number of participants with the AEs of interest between the two treatment groups using Fisher's exact test.|Fisher Exact|||Treatment start to Week 48||||1.000
72374762|NCT02189954|144260065|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Chi-squared|||||||<0.05
72374763|NCT02189954|144260065|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Mann Whitney U|||||||<0.05
72374764|NCT02509117|144260104|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-58.659|STANDARD_ERROR_OF_MEAN|0.0642|<|0.0001|TWO_SIDED|80.0|-61.95|-55.08|||Mixed Model Repeated Measures|||ABeta 1-40: General linear model with intervention, as the fixed effect and loge(baseline) as covariate.||-55.08|-61.95|<0.0001
72374765|NCT02509117|144260104|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-68.026|STANDARD_ERROR_OF_MEAN|0.0665|<|0.0001|TWO_SIDED|80.0|-70.66|-65.16|||Mixed Model Repeated Measures|||ABeta 1-40: General linear model with intervention, as the fixed effect and loge(baseline) as covariate.||-65.16|-70.66|<0.0001
72374766|NCT02509117|144260104|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-86.152|STANDARD_ERROR_OF_MEAN|0.0643|<|0.0001|TWO_SIDED|80.0|-87.26|-84.95|||Mixed Model Repeated Measures|||ABeta 1-40: General linear model with intervention, as the fixed effect and loge(baseline) as covariate.||-84.95|-87.26|<0.0001
72374767|NCT02509117|144260104|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-40.558|STANDARD_ERROR_OF_MEAN|0.0558|<|0.0001|TWO_SIDED|80.0|-44.7|-36.1|||Mixed Model Repeated Measures|||ABeta x-40: General linear model with intervention, as the fixed effect and loge(baseline) as covariate.||-36.10|-44.70|<0.0001
72374768|NCT02509117|144260104|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-51.368|STANDARD_ERROR_OF_MEAN|0.0561|<|0.0001|TWO_SIDED|80.0|-54.78|-47.7|||Mixed Model Repeated Measures|||ABeta x-40: General linear model with intervention, as the fixed effect and loge(baseline) as covariate.||-47.70|-54.78|<0.0001
72374769|NCT02509117|144260104|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-59.583|STANDARD_ERROR_OF_MEAN|0.0558|<|0.0001|TWO_SIDED|80.0|-62.4|-56.56|||Mixed Model Repeated Measures|||ABeta x-40: General linear model with intervention, as the fixed effect and loge(baseline) as covariate.||-56.56|-62.40|<0.0001
72374770|NCT02509117|144260104|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-37.373|STANDARD_ERROR_OF_MEAN|0.1007|<|0.0001|TWO_SIDED|80.0|-45.06|-28.62|||Mixed Model Repeated Measures|||ABeta Total: General linear model with intervention, as the fixed effect and loge(baseline) as covariate.||-28.62|-45.06|<0.0001
72374771|NCT02509117|144260104|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-45.018|STANDARD_ERROR_OF_MEAN|0.1001|<|0.0001|TWO_SIDED|80.0|-51.72|-37.38|||Mixed Model Repeated Measures|||ABeta Total: General linear model with intervention, as the fixed effect and loge(baseline) as covariate.||-37.38|-51.72|<0.0001
72374772|NCT02509117|144260104|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-61.797|STANDARD_ERROR_OF_MEAN|0.1014|<|0.0001|TWO_SIDED|80.0|-66.51|-56.42|||Mixed Model Repeated Measures|||ABeta Total: General linear model with intervention, as the fixed effect and loge(baseline) as covariate.||-56.42|-66.51|<0.0001
72374773|NCT01332461|144260117|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.649||||0.05|TWO_SIDED|95.0|0.455|0.926|||Log Rank||Covariates for risk models included Charlson Comorbidity Index, presence of asthma, number and quantity of rescue and controller medications, oxygen, and number of COPD healthcare resource use.|||0.926|0.455|0.05
72374774|NCT01332461|144260118|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.601|||<|0.05|TWO_SIDED|95.0|0.326|1.109||COPD-related hospitalization|Log Rank||Covariates for risk models included Charlson Comorbidity Index, presence of asthma, number and quantity of rescue and controller medications, oxygen, and number of COPD healthcare resource use.|||1.109|0.326|<0.05
72374775|NCT01332461|144260118|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.651|||<|0.05|TWO_SIDED|95.0|0.434|0.977||COPD-related ER visit|Log Rank||Covariates for risk models included Charlson Comorbidity Index, presence of asthma, number and quantity of rescue and controller medications, oxygen, and number of COPD healthcare resource use.|||0.977|0.434|<0.05
72374776|NCT01332461|144260118|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.815|||<|0.05|TWO_SIDED|95.0|0.658|1.008||COPD-related physician + Rx visit|Log Rank||Covariates for risk models included Charlson Comorbidity Index, presence of asthma, number and quantity of rescue and controller medications, oxygen, and number of COPD healthcare resource use.|||1.008|0.658|<0.05
72395074|NCT00720434|144296638|SUPERIORITY_OR_OTHER||Difference in Proportions|0.125|||||TWO_SIDED|95.0|-0.4024|0.6049||||||Week 48: The difference in proportions between treatment groups presented along with 95% CI, were based on exact method for small samples from the binomial distribution.||0.6049|-0.4024|
72504980|NCT01462292|144541163|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-892.88||||0.61|TWO_SIDED|95.0|-4391.1|2605.35||No adjustment for multiplicity was made, so p-values should not be used to make conclusions with regards to statistical significance|Mixed Model Repeated Measures|Model included terms for treatment, visit, treatment by visit, center grouping, baseline and baseline by visit||Treatment difference: Placebo Vs GSK2402968 3 mg, Week 24||2605.35|-4391.10|0.610
72374777|NCT01332461|144260118|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.785|||<|0.05|TWO_SIDED|95.0|0.649|0.948||COPD-related hospitalization/ER visit/physician+Rx|Log Rank||Covariates for risk models included Charlson Comorbidity Index, presence of asthma, number and quantity of rescue and controller medications, oxygen, and number of COPD healthcare resource use.|||0.948|0.649|<0.05
72374778|NCT00796991|144260122|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|0.963|||||TWO_SIDED|90.0|0.794|1.168|||Mixed Models Analysis|A general linear mixed model was applied to paclitaxel log(Cmax) using study day as a fixed effect.||Estimated effect of ipilimumab on paclitaxel Cmax. Point estimates and 90% confidence intervals (CIs) for means and differences between means on the log scale were exponentiated to obtain estimates for geometric means and ratio of geometric means on the original scale for the paclitaxel/carboplatin/ipilimumab combination (Day 43) relative to paclitaxel/carboplatin alone (Day 1)||1.168|0.794|
72374779|NCT00796991|144260122|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|1.027|||||TWO_SIDED|90.0|0.848|1.243|||Mixed Models Analysis|study day was used as a fixed effect||Estimated effect of ipilimumab on dacarbazine Cmax. Point estimates and 90% confidence intervals (CIs) for means and differences between means on the log scale were exponentiated to obtain estimates for geometric means and ratio of geometric means on the original scale for the dacarbazine, ipilimumab combination (Day 43) relative to dacarbazine alone (Day 1).||1.243|0.848|
72374780|NCT00796991|144260122|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|1.058|||||TWO_SIDED|90.0|0.974|1.15|||Mixed Models Analysis|study day was used as a fixed effect||Estimated effect of ipilimumab on AIC Cmax. Point estimates and 90% confidence intervals (CIs) for means and differences between means on the log scale were exponentiated to obtain estimates for geometric means and ratio of geometric means on the original scale for the dacarbazine, ipilimumab combination (Day 43) relative to dacarbazine alone (Day 1).||1.150|0.974|
72374781|NCT00796991|144260122|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|0.934||||||90.0|0.768|1.136|||linear model|treatment arm as a fixed effect||Estimated effect of paclitaxel/carboplatin on ipilimumab Cmax: linear model was applied to ipilimumab log(Cmax)) data from Week 7 (Day 43) PK measurements in first and third arms with treatment arm as a fixed effect. Point estimates and 90% CIs for means and differences between means on the log scale were exponentiated to obtain estimates for geometric means and ratio of geometric means on the original scale for the 3 drug combination relative to ipilimumab alone.||1.136|0.768|
72374782|NCT00796991|144260122|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|0.982|||||TWO_SIDED|90.0|0.798|1.208|||linear model|treatment arm as a fixed effect||Estimated effect of dacarbazine on ipilimumab Cmax: linear model was applied to ipilimumab log(Cmax) data from Week 7 (Day 43) PK measurements in second and third arms with treatment arm as a fixed effect. Point estimates and 90% CIs for means and differences between means on the log scale were exponentiated to obtain estimates for geometric means and ratio of geometric means on the original scale for the dacarbazine, ipilimumab combination relative to ipilimumab alone.||1.208|0.798|
72374783|NCT00796991|144260126|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.068|||||TWO_SIDED|90.0|0.954|1.196|||Mixed Models Analysis|A general linear mixed model was applied to paclitaxel log\[AUC(INF)\] using study day as a fixed effect.||Estimated effect of ipilimumab on paclitaxel AUC(INF). Point estimates and 90% confidence intervals (CIs) for means and differences between means on the log scale were exponentiated to obtain estimates for geometric means and ratio of geometric means on the original scale for the paclitaxel/carboplatin/ipilimumab combination (Day 43) relative to paclitaxel/carboplatin alone (Day 1).||1.196|0.954|
72374784|NCT00796991|144260126|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|0.912|||||TWO_SIDED|90.0|0.757|1.099|||Mixed Models Analysis|A general linear mixed model was applied to dacarbazine log\[AUC(INF)\] using study day as a fixed effect.||Estimated effect of ipilimumab on dacarbazine AUC(INF). Point estimates and 90% confidence intervals (CIs) for means and differences between means on the log scale were exponentiated to obtain estimates for geometric means and ratio of geometric means on the original scale for the dacarbazine, ipilimumab combination (Day 43) relative to dacarbazine alone (Day 1).||1.099|0.757|
72374785|NCT00796991|144260126|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|0.97|||||TWO_SIDED|90.0|0.891|1.056|||Mixed Models Analysis|A general linear mixed model was applied to active metabolite AIC log\[AUC(INF)\] using study day as a fixed effect.||Estimated effect of ipilimumab on AUC(INF) for AIC. Point estimates and 90% confidence intervals (CIs) for means and differences between means on the log scale were exponentiated to obtain estimates for geometric means and ratio of geometric means on the original scale for the dacarbazine, ipilimumab combination (Day 43) relative to dacarbazine alone (Day 1).||1.056|0.891|
72374786|NCT00796991|144260126|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|0.934|||||TWO_SIDED|90.0|0.768|1.136|||linear model|treatment arm as fixed effect||Estimated effect of paclitaxel/carboplatin on ipilimumab AUC: linear model was applied to ipilimumab log(AUC(0-21d)) data from Week 7 (Day 43) PK measurements in first and third arms with treatment arm as a fixed effect. Point estimates and 90% CIs for means and differences between means on the log scale were exponentiated to obtain estimates for geometric means and ratio of geometric means on the original scale for the 3 drug combination relative to ipilimumab alone.||1.136|0.768|
72374787|NCT00796991|144260126|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|0.982|||||TWO_SIDED|90.0|0.7981|1.208|||linear model|treatment arm as a fixed effect||Estimated effect of dacarbazine on ipilimumab AUC: linear model was applied to ipilimumab log(AUC(0-21d)) data from Week 7 (Day 43) PK measurements in second and third arms with treatment arm as a fixed effect. Point estimates and 90% CIs for means and differences between means on the log scale were exponentiated to obtain estimates for geometric means and ratio of geometric means on the original scale for the dacarbazine, ipilimumab combination relative to ipilimumab alone.||1.208|0.7981|
72504926|NCT02747043|144540915|EQUIVALENCE|Clinical equivalence of the primary endpoint will first be demonstrated by comparing the 1-sided 95% lower confidence limit of the RD of ORR by week 28 between ABP 798 and rituximab with a noninferiority margin of -15%. If this is successful, the 1-sided upper 95% confidence limit of the RD of ORR by week 28 will be compared with a nonsuperiority margin of +35.5%.|Risk Difference (RD)|7.7|||||TWO_SIDED|90.0|-1.4|16.8|||||The 2-sided 90% confidence limits of the risk difference (RD) of ORR by week 28 used a generalized linear model adjusted for the stratification factors (geographic region and age group).|||16.8|-1.4|
72374788|NCT00796991|144260132|SUPERIORITY_OR_OTHER|||||||0.027||||||p-value was not corrected for multiple testing. F-statistic = 1.86.|conditional F test|15 degrees freedom (DF) in numerator and 335 DF in denominator.||null hypothesis of no mean ALC changes over time in any treatment group. Conditional F-tests were used to test for mean ALC changes over time in each treatment arm and the difference between treatment arms in the pattern of change in ALC over time.||||0.027
72374789|NCT00796991|144260132|SUPERIORITY_OR_OTHER|||||||0.5||||||P-values were not corrected for multiple testing. F Statistic =0.94|Omnibus conditional F-test|10 Degrees Freedom (DF) in numerator and 335 DF in denominator.||null hypothesis that the pattern of mean ALC values over time is the same in all treatment groups. Test of overall time-by-treatment interaction used an omnibus conditional F-test.||||0.5
72374790|NCT00796991|144260132|SUPERIORITY_OR_OTHER|||||||0.37||||||P-values were not corrected for multiple testing. F Statistic =1.08|conditional F-test|5 Degrees Freedom (DF) in numerator and 335 DF in denominator.||null hypothesis that the pattern of mean ALC values over time is the same in the given pair of treatment groups.||||0.37
72374791|NCT00796991|144260132|SUPERIORITY_OR_OTHER|||||||0.85||||||P-values were not corrected for multiple testing. F Statistic =0.39|conditional F-test|5 Degrees Freedom (DF) in numerator and 335 DF in denominator.||null hypothesis that the pattern of mean ALC values over time is the same in the given pair of treatment groups.||||0.85
72374792|NCT00796991|144260132|SUPERIORITY_OR_OTHER|||||||0.22||||||P-values were not corrected for multiple testing. F Statistic = 1.41|conditional F-test|5 Degrees Freedom (DF) in numerator and 335 DF in denominator.||null hypothesis that the pattern of mean ALC values over time is the same in the given pair of treatment groups.||||0.22
72374793|NCT02199717|144260166|SUPERIORITY_OR_OTHER|||||||0.32|||||||Wilcoxon (Mann-Whitney)|||All statistical analyses were completed using SAS 9.4 (SAS Institute Inc., Cary, NC, USA). Descriptive statistics such as mean (± SD) and range were calculated and provided for demographic variables, accelerometry variables and questionnaire outcomes. Differences between the two groups (mild/moderate versus severe haemophilia) were examined in exploratory analyses.||||0.32
72374794|NCT02199717|144260167|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|306.4|||<|0.01|TWO_SIDED|95.0|254.8|358.0|||Wilcoxon (Mann-Whitney)|||||358|254.8|<0.01
72374795|NCT03567343|144260168|EQUIVALENCE|Significance set to 0.05|Mean Difference (Net)|-2.1||||0.1543|TWO_SIDED|95.0|-5.03|0.82||The threshold for statistical significance was P\< 0.05.|Paired T-test|||||0.82|-5.03|0.1543
72374796|NCT03567343|144260168|EQUIVALENCE|P\<0.05|Mean Difference (Net)|-2.53||||0.1827|TWO_SIDED|95.0|-6.3|1.24|||Paired T-test|||||1.24|-6.3|0.1827
72374797|NCT03567343|144260169|EQUIVALENCE|P\<0.05|Mean Difference (Net)|-0.2||||0.8165|TWO_SIDED|95.0|-1.96|1.56|||Paired T-test|||||1.56|-1.96|0.8165
72374798|NCT03567343|144260169|EQUIVALENCE|P\<0.05|Mean Difference (Net)|1.58||||0.1821|TWO_SIDED|95.0|-0.77|3.94|||Paired T-test|||||3.94|-0.77|0.1821
72374799|NCT03567343|144260170|EQUIVALENCE|P\<0.05|Mean Difference (Net)|20.94||||0.0156|TWO_SIDED|95.0|4.19|37.69|||Paired T-test|||||37.69|4.19|0.0156
72374800|NCT03567343|144260170|EQUIVALENCE|P\<0.05|Mean Difference (Net)|20.08||||0.0572|TWO_SIDED|95.0|-0.64|40.8|||Paired T-test|||||40.8|-0.64|0.0572
72374801|NCT03567343|144260171|EQUIVALENCE|P\<0.05|Mean Difference (Net)|-4.48||||0.0781|TWO_SIDED|95.0|-9.37|0.41|||Paired T-test|||||0.41|-9.37|0.0781
72374802|NCT03567343|144260171|EQUIVALENCE|P\<0.05|Mean Difference (Net)|-3.0||||0.242|TWO_SIDED|95.0|-8.1|2.1|||Paired T-test|||||2.1|-8.1|0.242
72374803|NCT03567343|144260172|EQUIVALENCE|P\<0.05|Mean Difference (Net)|2.91||||0.0195|TWO_SIDED|95.0|0.49|5.32|||Paired T-test|||||5.32|0.49|0.0195
72374804|NCT03567343|144260172|EQUIVALENCE|P\<0.05|Mean Difference (Net)|4.66||||0.0097|TWO_SIDED|95.0|1.19|8.12|||Paired T-test|||||8.12|1.19|0.0097
72374805|NCT03567343|144260173|EQUIVALENCE|P\<0.05|Mean Difference (Net)|0.93|||<|0.0001|TWO_SIDED|95.0|0.59|1.28|||Paired T-test|||||1.28|0.59|<0.0001
72374806|NCT03567343|144260173|EQUIVALENCE|P\<0.05|Mean Difference (Net)|0.45||||0.0179|TWO_SIDED|95.0|0.08|0.81|||Paired T-test|||||0.81|0.08|0.0179
72374807|NCT03567343|144260174|EQUIVALENCE|P\<0.05|Mean Difference (Net)|-0.03||||0.9875|TWO_SIDED|95.0|-3.89|3.83|||Paired T-test|||||3.83|-3.89|0.9875
72374808|NCT03567343|144260174|EQUIVALENCE|P\<0.05|Mean Difference (Net)|-0.2||||0.9463|TWO_SIDED|95.0|-6.23|5.82|||Paired T-test|||||5.82|-6.23|0.9463
72374809|NCT03567343|144260175|EQUIVALENCE|P\<0.05|Mean Difference (Net)|28.5||||0.0037|TWO_SIDED|95.0|9.84|47.17|||Paired T-test|||||47.17|9.84|0.0037
72374810|NCT03567343|144260175|EQUIVALENCE|p\<0.05|Mean Difference (Net)|9.84||||0.4395|TWO_SIDED|95.0|-15.63|35.31|||Paired T-test|||||35.31|-15.63|0.4395
72374811|NCT03567343|144260176|EQUIVALENCE|P\<0.05|Mean Difference (Net)|-0.03||||0.912|TWO_SIDED|95.0|-0.59|0.53|||Paired T-test|||||0.53|-0.59|0.912
72374812|NCT03567343|144260176|EQUIVALENCE|P\<0.05|Mean Difference (Net)|-0.11||||0.8207|TWO_SIDED|95.0|-1.04|0.83|||Paired T-test|||||0.83|-1.04|.8207
72374813|NCT03567343|144260177|EQUIVALENCE|P\<0.05|Mean Difference (Net)|-0.89||||0.1929|TWO_SIDED|95.0|-2.26|0.47|||Paired T-test|||||0.47|-2.26|0.1929
72374814|NCT03567343|144260177|EQUIVALENCE|P\<0.05|Mean Difference (Net)|-0.24||||0.8744|TWO_SIDED|95.0|-3.35|2.86|||Paired T-test|||||2.86|-3.35|0.8744
72374815|NCT03567343|144260178|EQUIVALENCE|P\<0.05|Mean Difference (Net)|-0.95||||0.2048|TWO_SIDED|95.0|-2.45|0.54|||Paired T-test|||||0.54|-2.45|0.2048
72374816|NCT03567343|144260178|EQUIVALENCE|P\<0.05|Mean Difference (Net)|0.96||||0.1933|TWO_SIDED|95.0|-0.5|2.42|||Paired T-test|||||2.42|-0.5|0.1933
72374817|NCT03567343|144260179|EQUIVALENCE|P\<0.05|Mean Difference (Net)|-1.69||||0.034|TWO_SIDED|95.0|-3.25|-0.13|||Paired T-test|||change in mean number of lapses||-0.13|-3.25|0.034
72374818|NCT03567343|144260179|EQUIVALENCE|P\<0.05|Mean Difference (Net)|0.41||||0.5242|TWO_SIDED|95.0|-0.88|1.71|||Paired T-test|||Change in number of lapses||1.71|-0.88|0.5242
72374819|NCT03567343|144260180|EQUIVALENCE|P\<0.05|Mean Difference (Net)|0.67||||0.8106|TWO_SIDED|95.0|-4.92|6.25|||Paired T-test|||POMS-TMD||6.25|-4.92|0.8106
72374820|NCT03567343|144260180|EQUIVALENCE|P\<0.05|Mean Difference (Net)|3.87||||0.1427|TWO_SIDED|95.0|-1.35|9.09|||Paired T-test|||POMS-TMD||9.09|-1.35|0.1427
72374821|NCT03567343|144260180|EQUIVALENCE|P\<0.05|Mean Difference (Net)|0.05||||0.9344|TWO_SIDED|95.0|-1.11|1.21|||Paired T-test|||POMS-Tension||1.21|-1.11|0.9344
72374822|NCT03567343|144260180|EQUIVALENCE|P\<0.05|Mean Difference (Net)|1.54||||0.0092|TWO_SIDED|95.0|0.4|2.69|||Paired T-test|||POMS-Tension||2.69|0.40|0.0092
72374823|NCT03567343|144260180|EQUIVALENCE|P\<0.05|Mean Difference (Net)|0.29||||0.755|TWO_SIDED|95.0|-1.55|2.12|||Paired T-test|||POMS-Depression||2.12|-1.55|0.755
72374824|NCT03567343|144260180|EQUIVALENCE|P\<0.05|Mean Difference (Net)|0.74||||0.2131|TWO_SIDED|95.0|-0.44|1.92|||Paired T-test|||POMS-Depression||1.92|-0.44|0.2131
72374825|NCT03567343|144260180|EQUIVALENCE|P\<0.05|Mean Difference (Net)|1.19||||0.06|TWO_SIDED|95.0|-0.05|2.43|||Paired T-test|||POMS-Anger||2.43|-0.05|0.06
72374826|NCT03567343|144260180|EQUIVALENCE|P\<0.05|Mean Difference (Net)|0.24||||0.4117|TWO_SIDED|95.0|-0.34|0.82|||Paired T-test|||POMS-Anger||0.82|-0.34|0.4117
72374827|NCT03567343|144260180|EQUIVALENCE|P\<0.05|Mean Difference (Net)|0.05||||0.9548|TWO_SIDED|95.0|-1.64|1.73|||Paired T-test|||POMS-Fatigue||1.73|-1.64|0.9548
72374828|NCT03567343|144260180|EQUIVALENCE|P\<0.05|Mean Difference (Net)|0.48||||0.4649|TWO_SIDED|95.0|-0.83|1.79|||Paired T-test|||POMS-Fatigue||1.79|-0.83|0.4649
72374829|NCT03567343|144260180|EQUIVALENCE|P\<0.05|Mean Difference (Net)|0.26||||0.5656|TWO_SIDED|95.0|-0.65|1.18|||Paired T-test|||POMS-Confusion||1.18|-0.65|0.5656
72374830|NCT03567343|144260180|EQUIVALENCE|P\<0.05|Mean Difference (Net)|0.33||||0.4307|TWO_SIDED|95.0|-0.5|1.15|||Paired T-test|||POMS-Confusion||1.15|-0.5|0.4307
72374831|NCT03567343|144260180|EQUIVALENCE|P\<0.05|Mean Difference (Net)|1.17||||0.2651|TWO_SIDED|95.0|-0.92|3.25|||Paired T-test|||POMS-Vigor||3.25|-0.92|0.2651
72374832|NCT03567343|144260180|EQUIVALENCE|P\<0.05|Mean Difference (Net)|-0.54||||0.5992|TWO_SIDED|95.0|-2.61|1.53|||Paired T-test|||POMS-Vigor||1.53|-2.61|0.5992
72374833|NCT03567343|144260181|EQUIVALENCE|P\<0.05|Mean Difference (Net)|0.37||||0.6869|TWO_SIDED|95.0|-1.48|2.22|||Paired T-test|||||2.22|-1.48|0.6869
72618320|NCT00286455|144767672|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.12||||0.702|TWO_SIDED|95.0|-0.74|0.5||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.50|-0.74|0.702
72374834|NCT03567343|144260181|EQUIVALENCE|P\<0.05|Mean Difference (Net)|1.39||||0.1769|TWO_SIDED|95.0|-0.65|3.43|||Paired T-test|||||3.43|-0.65|0.1769
72374835|NCT03567343|144260182|EQUIVALENCE|P\<0.05|Mean Difference (Net)|0.51||||0.6422|TWO_SIDED|95.0|-1.69|2.72|||Paired T-test|||||2.72|-1.69|0.6422
72374836|NCT03567343|144260182|EQUIVALENCE|P\<0.05|Mean Difference (Net)|0.63||||0.4106|TWO_SIDED|95.0|-0.9|2.16|||Paired T-test|||||2.16|-0.9|0.4106
72374837|NCT03567343|144260183|EQUIVALENCE|P\<0.05|Mean Difference (Net)|-0.23||||0.5672|TWO_SIDED|95.0|-1.05|0.58|||Paired T-test|||||0.58|-1.05|0.5672
72374838|NCT03567343|144260183|EQUIVALENCE|P\<0.05|Mean Difference (Net)|0.11||||0.805|TWO_SIDED|95.0|-0.77|0.99|||Paired T-test|||||0.99|-0.77|0.805
72374839|NCT03567343|144260184|EQUIVALENCE|P\<0.05|Median Difference (Net)|-43.09||||0.1236|TWO_SIDED|95.0|-98.43|12.26|||Paired T-test|||Change in lapse time||12.26|-98.43|.1236
72374840|NCT03567343|144260184|EQUIVALENCE|P\<0.05|Mean Difference (Net)|-2.01||||0.8241|TWO_SIDED|95.0|-20.13|16.11|||Paired T-test|||Change in lapse time||16.11|-20.13|.8241
72374841|NCT00678743|144260188|SUPERIORITY|All statistical significance were completed at the 5% level, two-tailed. Comparability of baseline characteristics between those who did and did not opt to enter the extension study was assessed with the chi square test and analysis of variance.||||||0.0008||||||Threshold for statistical significance p\<0.05|ANOVA|||||||0.0008
72374842|NCT01330017|144260192|SUPERIORITY_OR_OTHER|||||||0.4912||95.0||||The p-value reflects mean change from baseline vs. placebo from an ANCOVA model with adjustments for baseline reflective score value, investigative site, age, and gender.|ANCOVA|||||||0.4912
72374843|NCT01330017|144260192|SUPERIORITY_OR_OTHER|||||||0.4519||95.0||||The p-value reflects mean change from baseline vs. placebo from an ANCOVA model with adjustments for baseline reflective score value, investigative site, age, and gender.|ANCOVA|||||||0.4519
72374844|NCT01330017|144260192|SUPERIORITY_OR_OTHER|||||||0.2186||95.0||||The p-value reflects mean change from baseline vs. placebo from an ANCOVA model with adjustments for baseline reflective score value, investigative site, age, and gender.|ANCOVA|||||||0.2186
72374845|NCT01330017|144260192|SUPERIORITY_OR_OTHER|||||||0.5983||95.0||||The p-value reflects mean change from baseline vs. placebo from an ANCOVA model with adjustments for baseline reflective score value, investigative site, age, and gender.|ANCOVA|||||||0.5983
72374846|NCT01221272|144260205|SUPERIORITY_OR_OTHER||Mixed Models Analysis|0.67||||0.29|TWO_SIDED|95.0|-0.6|1.9||The null hypothesis that ranolazine treatment had no effect on PDS would be rejected if the PDS and TPD p-values were less than 0.05 or the PDS p-value was less than 0.05/2 = 0.025.|Mixed Models Analysis|||||1.9|-0.6|0.29
72374847|NCT01221272|144260206|SUPERIORITY_OR_OTHER||Mixed Models Analysis|0.65||||0.22|TWO_SIDED|95.0|-0.4|1.7||The null hypothesis that ranolazine treatment had no effect on TPD would be rejected if the PDS and TPD p-values were less than 0.05 or the TPD p-value was less than 0.05/2 = 0.025.|Mixed Models Analysis|||||1.7|-0.4|0.22
72374848|NCT01106092|144260213|NON_INFERIORITY|Criterion for evaluation of Non-inferiority: The upper limit (UL) of the standardized asymptotic 95% confidence interval (CI) on the group \[Zilbrix/Hib/Poliorix Group - GSK2036874A Group 1\] difference in percentage of seroprotected subjects ≤ 10%. The lower limit of the asymptotic 95% CI on the geometric mean of the individual ratios (post- over pre-booster titres) for anti-poliovirus type 1 is ≥ 2.|Difference in seroprotection rate|0.0|||||TWO_SIDED|95.0|-4.78|4.72||||||To demonstrate the non-inferiority of GSK2036874A vaccine (Formulation 1) compared to Poliorix™ vaccine co-administered with Zilbrix™/Hib vaccine, in terms of seroprotection rates to the three poliovirus types and to demonstrate that the formulation induces at least a two-fold increase in the geometric mean of the individual ratios (post- over pre-booster titres) for anti-polio type 1 antibodies, one month after vaccination.||4.72|-4.78|
72374849|NCT01106092|144260213|NON_INFERIORITY|Criterion for evaluation of Non-inferiority: The UL of the standardized asymptotic 95% CI on the group \[Zilbrix/Hib/Poliorix Group - GSK2036874A Group 2\] difference in percentage of seroprotected subjects ≤ 10%. The lower limit of the asymptotic 95% CI on the geometric mean of the individual ratios (post- over pre-booster titres) for anti-poliovirus type 1 is ≥ 2.|Difference in seroprotection rate|1.28|||||TWO_SIDED|95.0|-3.53|6.94||||||To demonstrate the non-inferiority of GSK2036874A vaccine (Formulation 2) compared to Poliorix™ vaccine co-administered with Zilbrix/Hib™ vaccine, in terms of seroprotection rates to the three poliovirus types and to demonstrate that the formulation induces at least a two-fold increase in the geometric mean of the individual ratios (post- over pre-booster titres) for anti-polio type 1 antibodies, one month after vaccination.||6.94|-3.53|
72395075|NCT00720434|144296638|SUPERIORITY_OR_OTHER||Difference in Proportions|-0.025||||||95.0|-0.4769|0.4336||||||Week 48: The difference in proportions between treatment groups presented along with 95% CI, were based on exact method for small samples from the binomial distribution.||0.4336|-0.4769|
72374850|NCT01106092|144260213|NON_INFERIORITY|Criterion for evaluation of Non-inferiority: The UL of the standardized asymptotic 95% CI on the group \[Zilbrix/Hib/Poliorix Group - GSK2036874A Group 3\] difference in percentage of seroprotected subjects ≤ 10%. The lower limit of the asymptotic 95% CI on the geometric mean of the individual ratios (post- over pre-booster titres) for anti-poliovirus type 1 is ≥ 2.|Difference in seroprotection rate|0.0|||||TWO_SIDED|95.0|-4.78|4.72||||||To demonstrate the non-inferiority of GSK2036874A vaccine (Formulation 3) compared to Poliorix™ vaccine co-administered with Zilbrix/Hib™ vaccine, in terms of seroprotection rates to the three poliovirus types and to demonstrate that the formulation induces at least a two-fold increase in the geometric mean of the individual ratios (post- over pre-booster titres) for anti-polio type 1 antibodies, one month after vaccination.||4.72|-4.78|
72374851|NCT01106092|144260213|NON_INFERIORITY|Criterion for evaluation of Non-inferiority: The UL of the standardized asymptotic 95% CI on the group \[Zilbrix/Hib/Poliorix Group - GSK2036874A Group 1\] difference in percentage of seroprotected subjects ≤ 10%. The lower limit of the asymptotic 95% CI on the geometric mean of the individual ratios (post- over pre-booster titres) for anti-poliovirus type 2 is ≥ 2.|Difference in seroprotection rate|0.0|||||TWO_SIDED|95.0|-4.78|4.78||||||To demonstrate the non-inferiority of GSK2036874A vaccine (Formulation 1) compared to Poliorix™ vaccine co-administered with Zilbrix/Hib™ vaccine, in terms of seroprotection rates to the three poliovirus types and to demonstrate that the formulation induces at least a two-fold increase in the geometric mean of the individual ratios (post- over pre-booster titres) for anti-polio type 2 antibodies, one month after vaccination.||4.78|-4.78|
72374852|NCT01106092|144260213|NON_INFERIORITY|Criterion for evaluation of Non-inferiority: The UL of the standardized asymptotic 95% CI on the group \[Zilbrix/Hib/Poliorix Group - GSK2036874A Group 2\] difference in percentage of seroprotected subjects ≤ 10%. The lower limit of the asymptotic 95% CI on the geometric mean of the individual ratios (post- over pre-booster titres) for anti-poliovirus type 2 is ≥ 2.|Difference in seroprotection rate|0.0|||||TWO_SIDED|95.0|-4.78|4.72||||||To demonstrate the non-inferiority of GSK2036874A vaccine (Formulation 2) compared to Poliorix™ vaccine co-administered with Zilbrix/Hib™ vaccine, in terms of seroprotection rates to the three poliovirus types and to demonstrate that the formulation induces at least a two-fold increase in the geometric mean of the individual ratios (post- over pre-booster titres) for anti-polio type 2 antibodies, one month after vaccination.||4.72|-4.78|
72374853|NCT01106092|144260213|NON_INFERIORITY|Criterion for evaluation of Non-inferiority: The UL of the standardized asymptotic 95% CI on the group \[Zilbrix/Hib/Poliorix Group - GSK2036874A Group 3\] difference in percentage of seroprotected subjects ≤ 10%. The lower limit of the asymptotic 95% CI on the geometric mean of the individual ratios (post- over pre-booster titres) for anti-poliovirus type 2 is ≥ 2.|Difference in seroprotection rate|0.0|||||TWO_SIDED|95.0|-4.78|4.72||||||To demonstrate the non-inferiority of GSK2036874A vaccine (Formulation 3) compared to Poliorix™ vaccine co-administered with Zilbrix/Hib™ vaccine, in terms of seroprotection rates to the three poliovirus types and to demonstrate that the formulation induces at least a two-fold increase in the geometric mean of the individual ratios (post- over pre-booster titres) for anti-polio type 2 antibodies, one month after vaccination.||4.72|-4.78|
72374854|NCT01106092|144260213|NON_INFERIORITY|Criterion for evaluation of Non-inferiority: The UL of the standardized asymptotic 95% CI on the group \[Zilbrix/Hib/Poliorix Group - GSK2036874A Group 1\] difference in percentage of seroprotected subjects ≤ 10%. The lower limit of the asymptotic 95% CI on the geometric mean of the individual ratios (post- over pre-booster titres) for anti-poliovirus type 3 is ≥ 2.|Difference in seroprotection rate|1.28|||||TWO_SIDED|95.0|-3.53|6.94||||||To demonstrate the non-inferiority of GSK2036874A vaccine (Formulation 1) compared to Poliorix™ vaccine co-administered with Zilbrix/Hib™ vaccine, in terms of seroprotection rates to the three poliovirus types and to demonstrate that the formulation induces at least a two-fold increase in the geometric mean of the individual ratios (post- over pre-booster titres) for anti-polio type 3 antibodies, one month after vaccination.||6.94|-3.53|
72374855|NCT01106092|144260213|NON_INFERIORITY|Criterion for evaluation of Non-inferiority: The UL of the standardized asymptotic 95% CI on the group \[Zilbrix/Hib/Poliorix Group - GSK2036874A Group 2\] difference in percentage of seroprotected subjects ≤ 10%. The lower limit of the asymptotic 95% CI on the geometric mean of the individual ratios (post- over pre-booster titres) for anti-poliovirus type 3 is ≥ 2.|Difference in seroprotection rate|1.28|||||TWO_SIDED|95.0|-3.53|6.94||||||To demonstrate the non-inferiority of GSK2036874A vaccine (Formulation 2) compared to Poliorix™ vaccine co-administered with Zilbrix/Hib™ vaccine, in terms of seroprotection rates to the three poliovirus types and to demonstrate that the formulation induces at least a two-fold increase in the geometric mean of the individual ratios (post- over pre-booster titres) for anti-polio type 3 antibodies, one month after vaccination.||6.94|-3.53|
72374856|NCT01106092|144260213|NON_INFERIORITY|Criterion for evaluation of Non-inferiority: The UL of the standardized asymptotic 95% CI on the group \[Zilbrix/Hib/Poliorix Group - GSK2036874A Group 3\] difference in percentage of seroprotected subjects ≤ 10%. The lower limit of the asymptotic 95% CI on the geometric mean of the individual ratios (post- over pre-booster titres) for anti-poliovirus type 3 is ≥ 2.|Difference in seroprotection rate|0.0|||||TWO_SIDED|95.0|-4.78|4.72||||||To demonstrate the non-inferiority of GSK2036874A vaccine (Formulation 3) compared to Poliorix™ vaccine co-administered with Zilbrix/Hib™ vaccine, in terms of seroprotection rates to the three poliovirus types and to demonstrate that the formulation induces at least a two-fold increase in the geometric mean of the individual ratios (post- over pre-booster titres) for anti-polio type 3 antibodies, one month after vaccination.||4.72|-4.78|
72374857|NCT01473368|144260238|SUPERIORITY_OR_OTHER|||||||0.026|||||||ANOVA|||||||0.026
72374858|NCT01473368|144260242|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
72374859|NCT04839562|144260245|SUPERIORITY||Mean Difference (Final Values)|-4.3|||=|0.0106|TWO_SIDED|95.0|-7.7|-1.0|||t-test, 2 sided|||||-1|-7.7|=.0106
72504927|NCT02747043|144540915|OTHER||Risk Difference (RD)|7.7|||||TWO_SIDED|95.0|-3.2|18.6||||||||18.6|-3.2|
72374860|NCT04839562|144260246|SUPERIORITY||||||=|0.002|||||||Fisher Exact|||||||=.002
72374861|NCT04839562|144260247|SUPERIORITY||||||=|0.0173|||||||Fisher Exact|||||||=.0173
72374862|NCT04839562|144260248|SUPERIORITY||||||=|0.1144|||||||Fisher Exact|||||||=.1144
72374863|NCT04839562|144260249|SUPERIORITY||||||=|0.0348|||||||Fisher Exact|||||||=.0348
72504928|NCT02747043|144540916|OTHER||Risk Difference (RD)|0.9|||||TWO_SIDED|90.0|-9.3|11.2||||||The 2-sided 90% confidence limits of the risk difference (RD) of ORR at week 12 used a generalized linear model adjusted for the stratification factors (geographic region and age group).||11.2|-9.3|
72374864|NCT04839562|144260250|SUPERIORITY||||||=|1|||||||Fisher Exact|||||||=1
72493906|NCT01978093|144516695|NON_INFERIORITY|Lower limit of the two-sided 97.5% CI on the GMC ratio (HibCY group over PedHIB group) for antibodies to S. pneumoniae serotype 18C is to be ≥0.5 (clinical limit for non-inferiority).|Adjusted GMC ratio|1.24|||||TWO_SIDED|97.5|1.01|1.52|||ANCOVA|GMC adjusted for BS subcohorts;97.5% CI for the adjusted GMC ratio(Ancova model:adjustment for BS subcohorts-pooled variance)|To be able to conclude independently on primary objectives of Epoch 001(Rotarix \& Prevnar13 post dose 3)\& Epoch 002(Havrix\&Prevnar13 post dose 4),a Bonferroni correction is used to test these primary objectives(1.25% 1sided for Epoch 001 \& Epoch 002)|GMC ratio between HibCY and PedHIB groups for antibodies to S. pneumoniae serotype 18C concentrations one month after the third dose.||1.52|1.01|
72493907|NCT01978093|144516695|NON_INFERIORITY|Lower limit of the two-sided 97.5% CI on the GMC ratio (HibCY group over PedHIB group) for antibodies to S. pneumoniae serotype 19A is to be≥0.5 (clinical limit for non-inferiority).|Adjusted GMC ratio|1.16|||||TWO_SIDED|97.5|0.94|1.43|||ANCOVA|GMC adjusted for BS subcohorts;97.5% CI for the adjusted GMC ratio(Ancova model:adjustment for BS subcohorts-pooled variance)|To be able to conclude independently on primary objectives of Epoch 001(Rotarix \& Prevnar13 post dose 3)\& Epoch 002(Havrix\&Prevnar13 post dose 4),a Bonferroni correction is used to test these primary objectives(1.25% 1sided for Epoch 001 \& Epoch 002)|GMC ratio between HibCY and PedHIB groups for antibodies to S. pneumoniae serotype 19A concentrations one month after the third dose.||1.43|0.94|
72493908|NCT01978093|144516695|NON_INFERIORITY|Lower limit of the two-sided 97.5% CI on the GMC ratio (HibCY group over PedHIB group) for antibodies to S. pneumoniae serotype 19F is to be≥0.5 (clinical limit for non-inferiority).|Adjusted GMC ratio|1.07|||||TWO_SIDED|97.5|0.89|1.29|||ANCOVA|GMC adjusted for BS subcohorts;97.5% CI for the adjusted GMC ratio(Ancova model:adjustment for BS subcohorts-pooled variance)|To be able to conclude independently on primary objectives of Epoch 001(Rotarix \& Prevnar13 post dose 3)\& Epoch 002(Havrix\&Prevnar13 post dose 4),a Bonferroni correction is used to test these primary objectives(1.25% 1sided for Epoch 001 \& Epoch 002)|GMC ratio between HibCY and PedHIB groups for antibodies to S. pneumoniae serotype 19F concentrations one month after the third dose.||1.29|0.89|
72493909|NCT01978093|144516695|NON_INFERIORITY|Lower limit of the two-sided 97.5% CI on the GMC ratio (HibCY group over PedHIB group) for antibodies to S. pneumoniae serotype 23F is to be≥0.5 (clinical limit for non-inferiority).|Adjusted GMC ratio|1.18|||||TWO_SIDED|97.5|0.91|1.53|||ANCOVA|GMC adjusted for BS subcohorts;97.5% CI for the adjusted GMC ratio(Ancova model:adjustment for BS subcohorts-pooled variance)|To be able to conclude independently on primary objectives of Epoch 001(Rotarix \& Prevnar13 post dose 3)\& Epoch 002(Havrix\&Prevnar13 post dose 4),a Bonferroni correction is used to test these primary objectives(1.25% 1sided for Epoch 001 \& Epoch 002)|GMC ratio between HibCY and PedHIB groups for antibodies to S. pneumoniae serotype 23F concentrations one month after the third dose.||1.53|0.91|
72493910|NCT01978093|144516696|NON_INFERIORITY|Lower limit of the two-sided standardized asymptotic 97.5% CI on the difference (HibCY group minus the PedHIB group) in the percentage of subjects with anti-HAV concentrations ≥15 mIU/mL is to be≥-10% (clinical limit for non-inferiority).|Difference in percentage of subjects|0.0|||||TWO_SIDED|97.5|-3.76|3.91|||Group difference in proportions||To be able to conclude independently on primary objectives of Epoch 001(Rotarix \& Prevnar13 post dose 3)\& Epoch 002(Havrix \& Prevnar13 post dose 4),Bonferroni correction is used to test these primary objectives(1.25% 1sided for Epoch 001 \& Epoch 002)|Difference between HibCY and PedHIB groups in percentage of subjects with anti-HAV concentrations equal to or above the cut-off value of 15 mIU/mL one month after the second Havrix dose.||3.91|-3.76|
72493911|NCT01978093|144516697|NON_INFERIORITY|Lower limit of the two-sided 97.5% CI on the GMC ratio (HibCY group over PedHIB group) for antibodies to S. pneumoniae serotype 1 is to be≥0.5 (clinical limit for non-inferiority).|Adjusted GMC ratio|1.25|||||TWO_SIDED|97.5|1.04|1.51|||ANCOVA|GMC adjusted for BS sub cohorts;97.5% CI for adjusted GMC ratio(Ancova model:adjustment for BS sub cohorts-pooled variance)|To be able to conclude independently on primary objectives of Epoch 001 \& Epoch 002, a Bonferroni correction is used to test these primary objectives(1.25% one-sided for Epoch 001 and Epoch 002)|GMC ratios between HibCY and PedHIB groups for antibodies to S. pneumoniae serotype 1 concentrations one month after the fourth dose||1.51|1.04|
72493912|NCT01978093|144516697|NON_INFERIORITY|Lower limit of the two-sided 97.5% CI on the GMC ratio (HibCY group over PedHIB group) for antibodies to S. pneumoniae serotype 3 is to be ≥0.5 (clinical limit for non-inferiority).|Adjusted GMC ratio|1.01|||||TWO_SIDED|97.5|0.83|1.24|||ANCOVA|GMC adjusted for BS sub cohorts;97.5% CI for adjusted GMC ratio(Ancova model:adjustment for BS sub cohorts-pooled variance)|To be able to conclude independently on primary objectives of Epoch 001 \& Epoch 002, a Bonferroni correction is used to test these primary objectives(1.25% one-sided for Epoch 001 and Epoch 002)|GMC ratios between HibCY and PedHIB groups for antibodies to S. pneumoniae serotype 3 concentrations one month after the fourth dose||1.24|0.83|
72493913|NCT01978093|144516697|NON_INFERIORITY|Lower limit of the two-sided 97.5% CI on the GMC ratio (HibCY group over PedHIB group) for antibodies to S. pneumoniae serotype 4 is to be≥0.5 (clinical limit for non-inferiority).|Adjusted GMC ratio|1.1|||||TWO_SIDED|97.5|0.92|1.31|||ANCOVA|GMC adjusted for BS sub cohorts;97.5% CI for adjusted GMC ratio(Ancova model:adjustment for BS sub cohorts-pooled variance)|To be able to conclude independently on primary objectives of Epoch 001 \& Epoch 002, a Bonferroni correction is used to test these primary objectives(1.25% one-sided for Epoch 001 and Epoch 002)|GMC ratios between HibCY and PedHIB groups for antibodies to S. pneumoniae serotype 4 concentrations one month after the fourth dose||1.31|0.92|
72374865|NCT04839562|144260251|SUPERIORITY||||||=|0.0173|||||||Fisher Exact|||||||=.0173
72374866|NCT04839562|144260252|SUPERIORITY||||||=|0.1864|||||||Fisher Exact|||||||=.1864
72374867|NCT04839562|144260253|SUPERIORITY||||||=|0.4173|||||||Fisher Exact|||||||=.4173
72374868|NCT04839562|144260254|SUPERIORITY||||||=|0.0343|||||||Fisher Exact|||||||=.0343
72374869|NCT04839562|144260255|SUPERIORITY||||||=|0.0636|||||||Fisher Exact|||||||=.0636
72374870|NCT04839562|144260256|SUPERIORITY||||||=|0.065|||||||Fisher Exact|||||||=.065
72374871|NCT04839562|144260257|SUPERIORITY||||||=|0.1144|||||||Fisher Exact|||||||=.1144
72374872|NCT04839562|144260258|SUPERIORITY||||||=|0.2829|||||||Fisher Exact|||||||=.2829
72374873|NCT01012219|144260282|SUPERIORITY_OR_OTHER||Geometric least-squares mean ratio|1.23|||||TWO_SIDED|90.0|0.96|1.56||||||||1.56|0.96|
72374874|NCT01350544|144260315|SUPERIORITY||Odds Ratio (OR)|0.79||||0.005|TWO_SIDED|95.0|0.69|0.91||a priori threshold for significance for p \< .05|Mixed Models Analysis|||We used generalized linear mixed models predicting adherence at baseline and 1.5-, 3-, 4.5-, and 6-months post-baseline, with intervention , time, interaction between intervention and time, medical and socio-demographic covariates, and baseline viral load. Sample size was determined with a power analysis assuming .80 power and an alpha level of .05 that would allow for detection of a small-to-medium effect size in adherence between arms.||0.91|0.69|.005
72374875|NCT01369329|144260390|SUPERIORITY_OR_OTHER|||||||0.002||||||A fixed sequence testing procedure was used to control alpha at 0.05 over the outcome measures.|Cochran-Mantel-Haenszel chi-square test|2-sided Cochran-Mantel-Haenszel chi-square test stratified by study region, CDAI score, and initial response to TNF antagonist therapy.||||||0.002
72374876|NCT01369329|144260390|SUPERIORITY_OR_OTHER|||||||0.003||||||A fixed sequence testing procedure was used to control alpha at 0.05 over the outcome measures.|Cochran-Mantel-Haenszel chi-square test|2-sided Cochran-Mantel-Haenszel chi-square test stratified by study region, CDAI score, and initial response to TNF antagonist therapy.||||||0.003
72374877|NCT01369329|144260391|SUPERIORITY_OR_OTHER|||||||0.003||||||A fixed sequence testing procedure was used to control alpha at 0.05 over the outcome measures.|Cochran-Mantel-Haenszel chi-square test|2-sided Cochran-Mantel-Haenszel chi-square test stratified by study region, CDAI score, and initial response to TNF antagonist therapy.||||||0.003
72374878|NCT01369329|144260391|SUPERIORITY_OR_OTHER||||||<|0.001||||||A fixed sequence testing procedure was used to control alpha at 0.05 over the outcome measures.|Cochran-Mantel-Haenszel chi-square test|2-sided Cochran-Mantel-Haenszel chi-square test stratified by study region, CDAI score, and initial response to TNF antagonist therapy.||||||< 0.001
72374879|NCT01369329|144260392|SUPERIORITY_OR_OTHER|||||||0.001||||||A fixed sequence testing procedure was used to control alpha at 0.05 over the outcome measures.|Cochran-Mantel-Haenszel chi-square test|2-sided Cochran-Mantel-Haenszel chi-square test stratified by study region, CDAI score, and initial response to TNF antagonist therapy.||||||0.001
72374880|NCT01369329|144260392|SUPERIORITY_OR_OTHER||||||<|0.001||||||A fixed sequence testing procedure was used to control alpha at 0.05 over the outcome measures.|Cochran-Mantel-Haenszel chi-square test|2-sided Cochran-Mantel-Haenszel chi-square test stratified by study region, CDAI score, and initial response to TNF antagonist therapy.||||||< 0.001
72374881|NCT01369329|144260393|SUPERIORITY_OR_OTHER||||||<|0.001||||||A fixed sequence testing procedure was used to control alpha at 0.05 over the outcome measures.|Cochran-Mantel-Haenszel chi-square test|2-sided Cochran-Mantel-Haenszel chi-square test stratified by study region, CDAI score, and initial response to TNF antagonist therapy.||||||< 0.001
72374882|NCT01369329|144260393|SUPERIORITY_OR_OTHER|||||||0.002||||||A fixed sequence testing procedure was used to control alpha at 0.05 over the outcome measures.|Cochran-Mantel-Haenszel chi-square test|2-sided Cochran-Mantel-Haenszel chi-square test stratified by study region, CDAI score, and initial response to TNF antagonist therapy.||||||0.002
72374883|NCT01369329|144260394|SUPERIORITY_OR_OTHER|||||||0.009||||||A fixed sequence testing procedure was used to control alpha at 0.05 over the outcome measures.|Cochran-Mantel-Haenszel chi-square test|2-sided Cochran-Mantel-Haenszel chi-square test stratified by study region, CDAI score, and initial response to TNF antagonist therapy.||||||0.009
72374884|NCT01369329|144260394|SUPERIORITY_OR_OTHER|||||||0.001||||||A fixed sequence testing procedure was used to control alpha at 0.05 over the outcome measures.|Cochran-Mantel-Haenszel chi-square test|2-sided Cochran-Mantel-Haenszel chi-square test stratified by study region, CDAI score, and initial response to TNF antagonist therapy.||||||0.001
72374885|NCT03259620|144260455|SUPERIORITY|||||||0.2587|||||||Cochran-Mantel-Haenszel|||||||0.2587
72374886|NCT00827931|144260460|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-99.9|STANDARD_ERROR_OF_MEAN|131.99||0.46|TWO_SIDED|95.0|-371.4|171.5|||t-test, 2 sided|||The null hypothesis applicable to the efficacy analyses was that there was no difference between tranexamic acid plus standard care compared to standard care alone. The alternative hypothesis was that there was a difference.||171.5|-371.4|0.460
72374887|NCT00827931|144260461|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-83.6|STANDARD_ERROR_OF_MEAN|147.61||0.579|TWO_SIDED|95.0|-386.5|219.3|||t-test, 2 sided|||The null hypothesis applicable to the efficacy analyses was that there was no difference between tranexamic acid plus standard care compared to standard care alone. The alternative hypothesis was that there was a difference.||219.3|-386.5|0.579
72374888|NCT00827931|144260462|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-183.5|STANDARD_ERROR_OF_MEAN|239.19||0.452|TWO_SIDED|95.0|-672.6|305.5|||t-test, 2 sided|||The null hypothesis applicable to the efficacy analyses was that there was no difference between tranexamic acid plus standard care compared to standard care alone. The alternative hypothesis was that there was a difference.||305.5|-672.6|0.452
72374889|NCT00827931|144260463|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-417.7|STANDARD_ERROR_OF_MEAN|152.51||0.01|TWO_SIDED|95.0|-729.4|-106.1|||t-test, 2 sided|||The null hypothesis applicable to the efficacy analyses was that there was no difference between tranexamic acid plus standard care compared to standard care alone. The alternative hypothesis was that there was a difference.||-106.1|-729.4|0.010
72374890|NCT00827931|144260464|SUPERIORITY_OR_OTHER|||||||0.701|TWO_SIDED||||||Fisher Exact|||Fisher's exact test was used at 5% level of significance.||||0.701
72374891|NCT02081859|144260486|OTHER|||||||0.41|||||||Chi-squared|||||||0.41
72374892|NCT02081859|144260487|OTHER|||||||0.21|||||||Chi-squared|||||||0.21
72395076|NCT00720434|144296638|SUPERIORITY_OR_OTHER||Difference in Proportions|0.125|||||TWO_SIDED|95.0|-0.4024|0.6049||||||Week 48: The difference in proportions between treatment groups presented along with 95% CI, were based on exact method for small samples from the binomial distribution.||0.6049|-0.4024|
72395077|NCT00720434|144296638|SUPERIORITY_OR_OTHER||Difference in Proportions|-0.15|||||TWO_SIDED|95.0|-0.5729|0.3149||||||Week 48: The difference in proportions between treatment groups presented along with 95% CI, were based on exact method for small samples from the binomial distribution.||0.3149|-0.5729|
72374893|NCT00492063|144260500|NON_INFERIORITY_OR_EQUIVALENCE|The percentage of subjects with HI titer ≥40 in the cTIV group is \>10% lower than in the TIV group (i.e., the percentage of subjects with HI titer ≥40 in the cTIV group is non-inferior to that of TIV group if, for strain A/H1N1, the lower limit of the 95% CI of the difference in the percentages is greater than -10%)|Group difference|0.0|||||TWO_SIDED|95.0|-3.0|3.0||||||Non-inferiority testing in immune response (HI titer ≥40) of cTIV to that of TIV vaccine for strain A/H1N1 after one vaccination in adults.||3|-3|
72395078|NCT00720434|144296638|SUPERIORITY_OR_OTHER||Difference in Proportions|-0.2|||||TWO_SIDED|95.0|-0.6191|0.2811||||||Week 60: The difference in proportions between treatment groups presented along with 95% CI, were based on exact method for small samples from the binomial distribution.||0.2811|-0.6191|
72374894|NCT00492063|144260500|NON_INFERIORITY_OR_EQUIVALENCE|The percentage of subjects with HI titer ≥40 in the cTIV group is \>10% lower than in the TIV group (i.e., the percentage of subjects with HI titer ≥40 in the cTIV group is non-inferior to that of TIV group if, for strain A/H3N2, the lower limit of the 95% CI of the difference in the percentages is greater than -10%)|Group difference|0.0|||||TWO_SIDED|95.0|-1.0|2.0||||||Non-inferiority testing in immune response (HI titer ≥40) of cTIV to that of TIV vaccine for strain A/H3N2 after one vaccination in adults.||2|-1|
72374895|NCT00492063|144260500|NON_INFERIORITY_OR_EQUIVALENCE|The percentage of subjects with HI titer ≥40 in the cTIV group is \>10% lower than in the TIV group (i.e., the percentage of subjects with HI titer ≥40 in the cTIV group is non-inferior to that of TIV group if, for strain B, the lower limit of the 95% CI of the difference in the percentages is greater than -10%)|Group difference|0.0|||||TWO_SIDED|95.0|-3.0|3.0||||||Non-inferiority testing in immune response (HI titer ≥40) of cTIV to that of TIV vaccine for strain B after one vaccination in adults.||3|-3|
72374896|NCT00492063|144260500|NON_INFERIORITY_OR_EQUIVALENCE|The percentage of subjects with HI titer ≥40 in the cTIV group is \>10% lower than in the TIV group (i.e., the percentage of subjects with HI titer ≥40 in the cTIV group is non-inferior to that of TIV group if, for strain A/H1N1, the lower limit of the 95% CI of the difference in the percentages is greater than -10%)|Group difference|-1.0|||||TWO_SIDED|95.0|-4.0|3.0||||||Non-inferiority testing in immune response (HI titer ≥40) of cTIV to that of TIV vaccine for strain A/H1N1 after one vaccination in the elderly population.||3|-4|
72374897|NCT00492063|144260500|NON_INFERIORITY_OR_EQUIVALENCE|The percentage of subjects with HI titer ≥40 in the cTIV group is \>10% lower than in the TIV group (i.e., the percentage of subjects with HI titer ≥40 in the cTIV group is non-inferior to that of TIV group if, for strain A/H3N2, the lower limit of the 95% CI of the difference in the percentages is greater than -10%)|Group difference|-1.0|||||TWO_SIDED|95.0|-2.0|1.0||||||Non-inferiority testing in immune response (HI titer ≥40) of cTIV to that of TIV vaccine for strain A/H3N2 after one vaccination in the elderly population.||1|-2|
72374898|NCT00492063|144260500|NON_INFERIORITY_OR_EQUIVALENCE|The percentage of subjects with HI titer ≥40 in the cTIV group is \>10% lower than in the TIV group (i.e., the percentage of subjects with HI titer ≥40 in the cTIV group is non-inferior to that of TIV group if, for strain B, the lower limit of the 95% CI of the difference in the percentages is greater than -10%)|Group difference|1.0|||||TWO_SIDED|95.0|-2.0|4.0||||||Non-inferiority testing in immune response (HI titer ≥40) of cTIV to that of TIV vaccine for strain B after one vaccination in the elderly population.||4|-2|
72374899|NCT00492063|144260501|NON_INFERIORITY_OR_EQUIVALENCE|The percentage of subjects with seroconversion or significant increase in HI titer in the cTIV group is \>10% lower than in the TIV group (i.e., the percentage of subjects with seroconversion or significant in HI titer of cTIV group is non-inferior to that of the TIV group if, for strain A/H1N1, the lower limit of the 95% CI of the difference in the percentages is greater than -10%).|Group difference|2.0|||||TWO_SIDED|95.0|-3.0|7.0||||||Non-inferiority testing in immune response (seroconversion or significant increase in HI titer) after one vaccination of cTIV to that of TIV vaccine for strain A/H1N1 in adults.||7|-3|
72374900|NCT00492063|144260501|NON_INFERIORITY_OR_EQUIVALENCE|The percentage of subjects with seroconversion or significant increase in HI titer in the cTIV group is \>10% lower than in the TIV group (i.e., the percentage of subjects with seroconversion or significant in HI titer of cTIV group is non-inferior to that of the TIV group if, for strain A/H3N2, the lower limit of the 95% CI of the difference in the percentages is greater than -10%).|Group difference|-1.0|||||TWO_SIDED|95.0|-6.0|4.0||||||Non-inferiority testing in immune response (seroconversion or significant increase in HI titer) after one vaccination of cTIV to that of TIV vaccine for strain A/H3N2 in adults.||4|-6|
72374901|NCT00492063|144260501|NON_INFERIORITY_OR_EQUIVALENCE|The percentage of subjects with seroconversion or significant increase in HI titer in the cTIV group is \>10% lower than in the TIV group (i.e., the percentage of subjects with seroconversion or significant in HI titer of cTIV group is non-inferior to that of the TIV group if, for strain B, the lower limit of the 95% CI of the difference in the percentages is greater than -10%).|Group difference|4.0|||||TWO_SIDED|95.0|0.0|8.0||||||Non-inferiority testing in immune response (seroconversion or significant increase in HI titer) after one vaccination of cTIV to that of TIV vaccine for strain B in adults.||8|0|
72395079|NCT00720434|144296638|SUPERIORITY_OR_OTHER||Difference in Proportions|0.0|||||TWO_SIDED|95.0|-0.507|0.507||||||Week 60: The difference in proportions between treatment groups presented along with 95% CI, were based on exact method for small samples from the binomial distribution.||0.5070|-0.5070|
72493914|NCT01978093|144516697|NON_INFERIORITY|Lower limit of the two-sided 97.5% CI on the GMC ratio (HibCY group over PedHIB group) for antibodies to S. pneumoniae serotype 5 is to be ≥0.5 (clinical limit for non-inferiority).|Adjusted GMC ratio|1.06|||||TWO_SIDED|97.5|0.87|1.28|||ANCOVA|GMC adjusted for BS sub cohorts;97.5% CI for adjusted GMC ratio(Ancova model:adjustment for BS sub cohorts-pooled variance)|To be able to conclude independently on primary objectives of Epoch 001 \& Epoch 002, a Bonferroni correction is used to test these primary objectives(1.25% one-sided for Epoch 001 and Epoch 002)|GMC ratios between HibCY and PedHIB groups for antibodies to S. pneumoniae serotype 5 concentrations one month after the fourth dose||1.28|0.87|
72493915|NCT01978093|144516697|NON_INFERIORITY|Lower limit of the two-sided 97.5% CI on the GMC ratio (HibCY group over PedHIB group) for antibodies to S. pneumoniae serotype 6A is to be≥0.5 (clinical limit for non-inferiority).|Adjusted GMC ratio|1.21|||||TWO_SIDED|97.5|1.01|1.44|||ANCOVA|GMC adjusted for BS sub cohorts;97.5% CI for adjusted GMC ratio(Ancova model:adjustment for BS sub cohorts-pooled variance)|To be able to conclude independently on primary objectives of Epoch 001 \& Epoch 002, a Bonferroni correction is used to test these primary objectives(1.25% one-sided for Epoch 001 and Epoch 002)|GMC ratios between HibCY and PedHIB groups for antibodies to S. pneumoniae serotype 6A concentrations one month after the fourth dose||1.44|1.01|
72493916|NCT01978093|144516697|NON_INFERIORITY|Lower limit of the two-sided 97.5% CI on the GMC ratio (HibCY group over PedHIB group) for antibodies to S. pneumoniae serotype 6B is to be≥0.5 (clinical limit for non-inferiority).|Adjusted GMC ratio|1.13|||||TWO_SIDED|97.5|0.94|1.36|||ANCOVA|GMC adjusted for BS sub cohorts;97.5% CI for adjusted GMC ratio(Ancova model:adjustment for BS sub cohorts-pooled variance)|To be able to conclude independently on primary objectives of Epoch 001 \& Epoch 002, a Bonferroni correction is used to test these primary objectives(1.25% one-sided for Epoch 001 and Epoch 002)|GMC ratios between HibCY and PedHIB groups for antibodies to S. pneumoniae serotype 6B concentrations one month after the fourth dose||1.36|0.94|
72374902|NCT00492063|144260501|NON_INFERIORITY_OR_EQUIVALENCE|The percentage of subjects with seroconversion or significant increase in HI titer in the cTIV group is \>10% lower than in the TIV group (i.e., the percentage of subjects with seroconversion or significant in HI titer of cTIV group is non-inferior to that of the TIV group if, for strain A/H1N1, the lower limit of the 95% CI of the difference in the percentages is greater than -10%).|Group difference|0.0|||||TWO_SIDED|95.0|-6.0|5.0||||||Non-inferiority testing in immune response (seroconversion or significant increase in HI titer) after one vaccination of cTIV to that of TIV vaccine for strain A/H1N1 in the elderly population.||5|-6|
72374903|NCT00492063|144260501|NON_INFERIORITY_OR_EQUIVALENCE|The percentage of subjects with seroconversion or significant increase in HI titer in the cTIV group is \>10% lower than in the TIV group (i.e., the percentage of subjects with seroconversion or significant in HI titer of cTIV group is non-inferior to that of the TIV group if, for strain A/H3N2, the lower limit of the 95% CI of the difference in the percentages is greater than -10%).|Group difference|3.0|||||TWO_SIDED|95.0|-2.0|8.0||||||Non-inferiority testing in immune response (seroconversion or significant increase in HI titer) after one vaccination of cTIV to that of TIV vaccine for strain A/H3N2 in the elderly population.||8|-2|
72374904|NCT00492063|144260501|NON_INFERIORITY_OR_EQUIVALENCE|The percentage of subjects with seroconversion or significant increase in HI titer in the cTIV group is \>10% lower than in the TIV group (i.e., the percentage of subjects with seroconversion or significant in HI titer of cTIV group is non-inferior to that of the TIV group if, for strain B, the lower limit of the 95% CI of the difference in the percentages is greater than -10%).|Group difference|6.0|||||TWO_SIDED|95.0|2.0|11.0||||||Non-inferiority testing in immune response (seroconversion or significant increase in HI titer) after one vaccination of cTIV to that of TIV vaccine for strain B in the elderly population.||11|2|
72374905|NCT00492063|144260502|NON_INFERIORITY_OR_EQUIVALENCE|The value of GMR ratio of cTIV to TIV is \>0.5 (i.e., the GMR of the cTIV group is non-inferior to that of the TIV group if, for strain A/H1N1, the lower limit of the 95% CI for ratio of GMRs at day 22 is greater than 0.5).|Ratio of GMRs|1.07|||||TWO_SIDED|95.0|0.9|1.28||||||Non-inferiority testing in immune response (GMR) after one vaccination of cTIV to that of TIV vaccine for strain A/H1N1 in adults.||1.28|0.9|
72374906|NCT00492063|144260502|NON_INFERIORITY_OR_EQUIVALENCE|The value of GMR ratio of cTIV to TIV is \>0.5 (i.e., the GMR of the cTIV group is non-inferior to that of the TIV group if, for strain A/H3N2, the lower limit of the 95% CI for ratio of GMRs at day 22 is greater than 0.5).|Ratio of GMRs|0.85|||||TWO_SIDED|95.0|0.72|0.99||||||Non-inferiority testing in immune response (GMR) after one vaccination of cTIV to that of TIV vaccine for strain A/H3N2 in adults.||0.99|0.72|
72374907|NCT00492063|144260502|NON_INFERIORITY_OR_EQUIVALENCE|The value of GMR ratio of cTIV to TIV is \>0.5 (i.e., the GMR of the cTIV group is non-inferior to that of the TIV group if, for strain B, the lower limit of the 95% CI for ratio of GMRs at day 22 is greater than 0.5).|Ratio of GMRs|1.14|||||TWO_SIDED|95.0|0.99|1.3||||||Non-inferiority testing in immune response (GMR) after one vaccination of cTIV to that of TIV vaccine for strain B in adults.||1.3|0.99|
72374908|NCT00492063|144260502|NON_INFERIORITY_OR_EQUIVALENCE|The value of GMR ratio of cTIV to TIV is \>0.5 (i.e., the GMR of the cTIV group is non-inferior to that of the TIV group if, for strain A/H1N1, the lower limit of the 95% CI for ratio of GMRs at day 22 is greater than 0.5).|Ratio of GMRs|0.96|||||TWO_SIDED|95.0|0.82|1.12||||||Non-inferiority testing in immune response (GMR) after one vaccination of cTIV to that of TIV vaccine for strain A/H1N1 in the elderly population.||1.12|0.82|
72374909|NCT00492063|144260502|NON_INFERIORITY_OR_EQUIVALENCE|The value of GMR ratio of cTIV to TIV is \>0.5 (i.e., the GMR of the cTIV group is non-inferior to that of the TIV group if, for strain A/H3N2, the lower limit of the 95% CI for ratio of GMRs at day 22 is greater than 0.5).|Ratio of GMRs|0.87|||||TWO_SIDED|95.0|0.74|1.02||||||Non-inferiority testing in immune response (GMR) after one vaccination of cTIV to that of TIV vaccine for strain A/H3N2 in the elderly population.||1.02|0.74|
72374910|NCT00492063|144260502|NON_INFERIORITY_OR_EQUIVALENCE|The value of GMR ratio of cTIV to TIV is \>0.5 (i.e., the GMR of the cTIV group is non-inferior to that of the TIV group if, for strain B, the lower limit of the 95% CI for ratio of GMRs at day 22 is greater than 0.5).|Ratio of GMRs|1.27|||||TWO_SIDED|95.0|1.11|1.4||||||Non-inferiority testing in immune response (GMR) after one vaccination of cTIV to that of TIV vaccine for strain B in the elderly population.||1.4|1.11|
72374911|NCT04157673|144260515|SUPERIORITY|||||||0.0002||||||This is the overall treatment effect from the mixed model. p-value threshold set at p = 0.05.|Mixed Models Analysis|||Statistical analysis to support visual inspection of the multiple-baseline graphs included the phase changes from baseline to Episodic future thinking treatment. Phase changes were assessed using mixed model with fixed effects of level and trend for baseline phase and random effects for level and trend for treatment phase.||||0.0002
72374912|NCT04157673|144260516|OTHER|Effect size of mean differences|Mean Difference (Final Values)|2.75|STANDARD_DEVIATION|3.78|||TWO_SIDED||||||||Cohen's d effect size = 0.73|Statistical analysis to support visual inspection of the multiple-baseline graphs included the phase changes from baseline to Episodic future thinking treatment. Phase changes were assessed using mixed model with fixed effects of level and trend for baseline phase and random effects for level and trend for treatment phase.||||
72374913|NCT04157673|144260517|OTHER|Effect size of mean pre-post differences|Mean Difference (Final Values)|0.355|STANDARD_DEVIATION|0.295|||TWO_SIDED||||||||cohen's d effect size for mean differences pre to post-treatment = 1.20|||||
72374914|NCT03011892|144260518|SUPERIORITY||Difference in Least Square (LS) Mean|-59.66|||<|0.0001|TWO_SIDED|95.0|-77.85|-41.47|||MMRM|||||-41.47|-77.85|< 0.0001
72374915|NCT03011892|144260519|SUPERIORITY||Difference in LS Mean|-33.01||||0.0004|TWO_SIDED|95.0|-51.27|-14.76|||MMRM|||DB: Vehicle BID, Ruxolitinib 0.15% QD||-14.76|-51.27|0.0004
72374916|NCT03011892|144260519|SUPERIORITY||Difference in LS Mean|-40.9|||<|0.0001|TWO_SIDED|95.0|-59.23|-22.57|||MMRM|||||-22.57|-59.23|< 0.0001
72374917|NCT03011892|144260519|SUPERIORITY||Difference in LS Mean|-54.82|||<|0.0001|TWO_SIDED|95.0|-72.93|-36.7|||MMRM|||||-36.70|-72.93|< 0.0001
72374918|NCT03011892|144260520|SUPERIORITY||Difference in LS Mean|14.63||||0.1127|TWO_SIDED|95.0|-3.47|32.73|||MMRM|||Triamcinolone 0.1% BID/Vehicle Cream BID, DB: Ruxolitinib 0.15% QD||32.73|-3.47|0.1127
72374919|NCT03011892|144260520|SUPERIORITY||Difference in LS Mean|6.74||||0.4659|TWO_SIDED|95.0|-11.44|24.92|||MMRM|||Triamcinolone 0.1% BID/Vehicle Cream BID, DB: Ruxolitinib 0.5% QD||24.92|-11.44|0.4659
72374920|NCT03011892|144260520|SUPERIORITY||Difference in LS Mean|-7.18||||0.432|TWO_SIDED|95.0|-25.13|10.77|||MMRM|||Triamcinolone 0.1% BID/Vehicle Cream BID, DB: Ruxolitinib 1.5% QD||10.77|-25.13|0.4320
72374921|NCT03011892|144260520|SUPERIORITY||Difference in LS Mean|-12.02||||0.1903|TWO_SIDED|95.0|-30.05|6.0|||MMRM|||||6.00|-30.05|0.1903
72374922|NCT03011892|144260521|SUPERIORITY||Difference in LS Mean|-25.12||||0.0009|TWO_SIDED|95.0|-39.84|-10.41|||MMRM|||Week 2||-10.41|-39.84|0.0009
72374923|NCT03011892|144260521|SUPERIORITY||Difference in LS Mean|-47.85|||<|0.0001|TWO_SIDED|95.0|-62.64|-33.06|||MMRM|||Week 2||-33.06|-62.64|< 0.0001
72374924|NCT03011892|144260521|SUPERIORITY||Difference in LS Mean|-41.04|||<|0.0001|TWO_SIDED|95.0|-56.0|-26.08|||MMRM|||Week 2||-26.08|-56.00|< 0.0001
72374925|NCT03011892|144260521|SUPERIORITY||Difference in LS Mean|-45.05|||<|0.0001|TWO_SIDED|95.0|-59.69|-30.4|||MMRM|||Week 2||-30.40|-59.69|< 0.0001
72374926|NCT03011892|144260521|SUPERIORITY||Difference in LS Mean|9.99||||0.1806|TWO_SIDED|95.0|-4.66|24.63|||MMRM|||Week 2||24.63|-4.66|0.1806
72374927|NCT03011892|144260521|SUPERIORITY||Difference in LS Mean|-5.93||||0.4333|TWO_SIDED|95.0|-20.82|8.95|||MMRM|||Week 2||8.95|-20.82|0.4333
72374928|NCT03011892|144260521|SUPERIORITY||Difference in LS Mean|-9.94||||0.1805|TWO_SIDED|95.0|-24.51|4.63|||MMRM|||Week 2||4.63|-24.51|0.1805
72374929|NCT03011892|144260521|SUPERIORITY||Difference in LS Mean|-12.74||||0.0895|TWO_SIDED|95.0|-27.45|1.98|||MMRM|||Week 2||1.98|-27.45|0.0895
72374930|NCT03011892|144260521|SUPERIORITY||Difference in LS Mean|-28.38||||0.0042|TWO_SIDED|95.0|-47.74|-9.02|||MMRM|||Week 8||-9.02|-47.74|0.0042
72374931|NCT03011892|144260521|SUPERIORITY||Difference in LS Mean|-36.52||||0.0003|TWO_SIDED|95.0|-56.03|-17.01|||MMRM|||Week 8||-17.01|-56.03|0.0003
72374932|NCT03011892|144260521|SUPERIORITY||Difference in LS Mean|-45.19|||<|0.0001|TWO_SIDED|95.0|||||MMRM|||Week 8||||< 0.0001
72374933|NCT03011892|144260521|SUPERIORITY||Difference in LS Mean|-57.15|||<|0.0001|TWO_SIDED|95.0|-76.53|-37.77|||MMRM|||Week 8||-37.77|-76.53|< 0.0001
72555697|NCT02558491|144642699|OTHER|||||||0.863||||||No a priori sample size was determined due to the feasibility/pilot nature of the trial. Significance level was set at P-value \<0.05.|ANOVA|||Secondary analysis followed the same format unless variables could not be considered normally distributed; in that case a related samples Wilcoxon signed-rank test is used. Data were first binned (to ensure minimum count of five per bins) and the w2 statistics was used with the expected counts given by SoC. Based on achieved recruitment, a moderate effect size (0.3) is detectable with 80% power, or a large effect size (0.4) with 95% power (G-Power 3.1.9.2). Outcome measurement was for overall.||||0.863
72618321|NCT00286455|144767672|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3||||0.338|TWO_SIDED|95.0|-0.32|0.93||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.93|-0.32|0.338
72618322|NCT00286455|144767673|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01||||0.978|TWO_SIDED|95.0|-0.74|0.72||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.72|-0.74|0.978
72374934|NCT03011892|144260521|SUPERIORITY||Difference in LS Mean|7.78||||0.4243|TWO_SIDED|95.0|-11.37|26.93|||MMRM|||Week 8||26.93|-11.37|0.4243
72374935|NCT03011892|144260521|SUPERIORITY||Difference in LS Mean|-0.35||||0.9715|TWO_SIDED|95.0|-19.65|18.95|||MMRM|||Week 8||18.95|-19.65|0.9715
72374936|NCT03011892|144260521|SUPERIORITY||Difference in LS Mean|-9.03||||0.3507|TWO_SIDED|95.0|-28.05|9.99|||MMRM|||Week 8||9.99|-28.05|0.3507
72618323|NCT00286455|144767673|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.991|TWO_SIDED|95.0|-0.73|0.74||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.74|-0.73|0.991
72374937|NCT03011892|144260521|SUPERIORITY||Difference in LS Mean|-20.98||||0.032|TWO_SIDED|95.0|-40.15|-1.82|||MMRM|||Week 8||-1.82|-40.15|0.0320
72374938|NCT02312687|144260537|SUPERIORITY||Least Squares (LS) Mean|0.68|||<|0.0001|TWO_SIDED|95.0|0.48|0.88||The generalized estimation equation (GEE) model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|generalized estimation equation (GEE)|||Change at Week 24||0.88|0.48|< 0.0001
72374939|NCT02312687|144260537|SUPERIORITY||LS Mean|0.68|||<|0.0001|TWO_SIDED|95.0|0.57|0.79||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 48||0.79|0.57|< 0.0001
72374940|NCT02312687|144260537|SUPERIORITY||LS Mean|0.59|||<|0.0001|TWO_SIDED|95.0|0.44|0.75||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 72||0.75|0.44|< 0.0001
72374941|NCT02312687|144260537|SUPERIORITY||LS Mean|0.47|||<|0.0001|TWO_SIDED|95.0|0.31|0.63||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 96||0.63|0.31|< 0.0001
72374942|NCT02312687|144260537|SUPERIORITY||LS Mean|0.57|||<|0.0001|TWO_SIDED|95.0|0.41|0.73||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 120||0.73|0.41|< 0.0001
72374943|NCT02312687|144260537|SUPERIORITY||LS Mean|0.59|||<|0.0001|TWO_SIDED|95.0|0.43|0.76||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 144||0.76|0.43|< 0.0001
72374944|NCT02312687|144260538|SUPERIORITY||LS Mean|-9.75||||0.1366|TWO_SIDED|95.0|-22.59|3.09||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE estimate|||Change at Week 24||3.09|-22.59|0.1366
72374945|NCT02312687|144260538|SUPERIORITY||LS Mean|-11.17||||0.1334|TWO_SIDED|95.0|-25.76|3.42||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE estimate|||Change at Week 48||3.42|-25.76|0.1334
72374946|NCT02312687|144260538|SUPERIORITY||LS Mean|-18.12|||<|0.0001|TWO_SIDED|95.0|-27.07|-9.17||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE estimate|||Change at Week 72||-9.17|-27.07|< 0.0001
72374947|NCT02312687|144260538|SUPERIORITY||LS Mean|-25.28|||<|0.0001|TWO_SIDED|95.0|-36.21|-14.35||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE estimate|||Change at Week 96||-14.35|-36.21|< 0.0001
72374948|NCT02312687|144260538|SUPERIORITY||LS Mean|-22.39|||<|0.0001|TWO_SIDED|95.0|-31.51|-13.26||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE estimate|||Change at Week 120||-13.26|-31.51|< 0.0001
72374949|NCT02312687|144260538|SUPERIORITY||LS Mean|-28.33|||<|0.0001|TWO_SIDED|95.0|-40.11|-16.56||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE estimate|||Change at Week 144||-16.56|-40.11|< 0.0001
72374950|NCT02312687|144260539|SUPERIORITY||LS Mean|215493.38|||<|0.0001|TWO_SIDED|95.0|194650.78|236335.97||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 24||236335.97|194650.78|< 0.0001
72374951|NCT02312687|144260539|SUPERIORITY||LS Mean|202525.38|||<|0.0001|TWO_SIDED|95.0|168364.92|236685.83||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 48||236685.83|168364.92|< 0.0001
72374952|NCT02312687|144260539|SUPERIORITY||LS Mean|221481.03|||<|0.0001|TWO_SIDED|95.0|179628.07|263333.98||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 72||263333.98|179628.07|< 0.0001
72374953|NCT02312687|144260539|SUPERIORITY||LS Mean|221674.07|||<|0.0001|TWO_SIDED|95.0|181313.34|262034.81||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 96||262034.81|181313.34|< 0.0001
72374954|NCT02312687|144260539|SUPERIORITY||LS Mean|208270.02|||<|0.0001|TWO_SIDED|95.0|167217.98|249322.06||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 120||249322.06|167217.98|< 0.0001
72374955|NCT02312687|144260539|SUPERIORITY||LS Mean|235953.55|||<|0.0001|TWO_SIDED|95.0|166110.59|305796.52||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 144||305796.52|166110.59|< 0.0001
72374956|NCT02312687|144260540|SUPERIORITY||LS Mean|1277.84|||<|0.0001|TWO_SIDED|95.0|1202.34|1353.34||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 24||1353.34|1202.34|< 0.0001
72374957|NCT02312687|144260540|SUPERIORITY||LS Mean|1244.99|||<|0.0001|TWO_SIDED|95.0|1166.1|1323.88||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 48||1323.88|1166.10|< 0.0001
72374958|NCT02312687|144260540|SUPERIORITY||LS Mean|1298.49|||<|0.0001|TWO_SIDED|95.0|1233.56|1363.43||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 72||1363.43|1233.56|< 0.0001
72493917|NCT01978093|144516697|NON_INFERIORITY|Lower limit of the two-sided 97.5% CI on the GMC ratio (HibCY group over PedHIB group) for antibodies to S. pneumoniae serotype 7F is to be ≥0.5 (clinical limit for non-inferiority).|Adjusted GMC ratio|1.09|||||TWO_SIDED|97.5|0.93|1.29|||ANCOVA|GMC adjusted for BS sub cohorts;97.5% CI for adjusted GMC ratio(Ancova model:adjustment for BS sub cohorts-pooled variance)|To be able to conclude independently on primary objectives of Epoch 001 \& Epoch 002, a Bonferroni correction is used to test these primary objectives(1.25% one-sided for Epoch 001 and Epoch 002)|GMC ratios between HibCY and PedHIB groups for antibodies to S. pneumoniae serotype 7F concentrations one month after the fourth dose||1.29|0.93|
72374959|NCT02312687|144260540|SUPERIORITY||LS Mean|1311.05|||<|0.0001|TWO_SIDED|95.0|1238.3|1383.8||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 96||1383.80|1238.30|< 0.0001
72374960|NCT02312687|144260540|SUPERIORITY||LS Mean|1368.68|||<|0.0001|TWO_SIDED|95.0|1327.4|1409.96||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 120||1409.96|1327.40|< 0.0001
72493918|NCT01978093|144516697|NON_INFERIORITY|Lower limit of the two-sided 97.5% CI on the GMC ratio (HibCY group over PedHIB group) for antibodies to S. pneumoniae serotype 9V is to be ≥0.5 (clinical limit for non-inferiority).|Adjusted GMC ratio|1.12|||||TWO_SIDED|97.5|0.94|1.33|||ANCOVA|GMC adjusted for BS sub cohorts;97.5% CI for adjusted GMC ratio(Ancova model:adjustment for BS sub cohorts-pooled variance)|To be able to conclude independently on primary objectives of Epoch 001 \& Epoch 002, a Bonferroni correction is used to test these primary objectives(1.25% one-sided for Epoch 001 and Epoch 002)|GMC ratios between HibCY and PedHIB groups for antibodies to S. pneumoniae serotype 9V concentrations one month after the fourth dose||1.33|0.94|
72493919|NCT01978093|144516697|NON_INFERIORITY|Lower limit of the two-sided 97.5% CI on the GMC ratio (HibCY group over PedHIB group) for antibodies to S. pneumoniae serotype 14 is to be≥0.5 (clinical limit for non-inferiority).|Adjusted GMC ratio|1.16|||||TWO_SIDED|97.5|0.96|1.41|||ANCOVA|GMC adjusted for BS sub cohorts;97.5% CI for adjusted GMC ratio(Ancova model:adjustment for BS sub cohorts-pooled variance)|To be able to conclude independently on primary objectives of Epoch 001 \& Epoch 002, a Bonferroni correction is used to test these primary objectives(1.25% one-sided for Epoch 001 and Epoch 002)|GMC ratios between HibCY and PedHIB groups for antibodies to S. pneumoniae serotype 14 concentrations one month after the fourth dose||1.41|0.96|
72374961|NCT02312687|144260540|SUPERIORITY||LS Mean|1298.41|||<|0.0001|TWO_SIDED|95.0|1208.31|1388.51||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 144||1388.51|1208.31|< 0.0001
72374962|NCT02312687|144260541|SUPERIORITY||LS Mean|7.87||||0.0011|TWO_SIDED|95.0|3.16|12.58||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 24||12.58|3.16|0.0011
72374963|NCT02312687|144260541|SUPERIORITY||LS Mean|2.7||||0.3092|TWO_SIDED|95.0|-2.5|7.9||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 48||7.90|-2.50|0.3092
72555698|NCT02558491|144642699|OTHER|||||||0.965||||||No a priori sample size was determined due to the feasibility/pilot nature of the trial. Significance level was set at P-value \<0.05.|ANOVA|||Secondary analysis followed the same format unless variables could not be considered normally distributed; in that case a related samples Wilcoxon signed-rank test is used. Data were first binned (to ensure minimum count of five per bins) and the w2 statistics was used with the expected counts given by SoC. Based on achieved recruitment, a moderate effect size (0.3) is detectable with 80% power, or a large effect size (0.4) with 95% power (G-Power 3.1.9.2). Outcome measurement was for mealtime.||||0.965
72374964|NCT02312687|144260541|SUPERIORITY||LS Mean|2.62||||0.2958|TWO_SIDED|95.0|-2.29|7.53||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 72||7.53|-2.29|0.2958
72374965|NCT02312687|144260541|SUPERIORITY||LS Mean|0.31||||0.8796|TWO_SIDED|95.0|-3.71|4.33||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 96||4.33|-3.71|0.8796
72555699|NCT02558491|144642699|OTHER|||||||0.742||||||No a priori sample size was determined due to the feasibility/pilot nature of the trial. Significance level was set at P-value \<0.05.|ANOVA|||Secondary analysis followed the same format unless variables could not be considered normally distributed; in that case a related samples Wilcoxon signed-rank test is used. Data were first binned (to ensure minimum count of five per bins) and the w2 statistics was used with the expected counts given by SoC. Based on achieved recruitment, a moderate effect size (0.3) is detectable with 80% power, or a large effect size (0.4) with 95% power (G-Power 3.1.9.2). Outcome measurement was for overnight.||||0.742
72555700|NCT02558491|144642700|OTHER|||||||0.158||||||No a priori sample size was determined due to the feasibility/pilot nature of the trial. Significance level was set at P-value \<0.05.|Wilcoxon (Mann-Whitney)|||Secondary analysis followed the same format unless variables could not be considered normally distributed; in that case a related samples Wilcoxon signed-rank test is used. Data were first binned (to ensure minimum count of five per bins) and the w2 statistics was used with the expected counts given by SoC. Based on achieved recruitment, a moderate effect size (0.3) is detectable with 80% power, or a large effect size (0.4) with 95% power (G-Power 3.1.9.2). Outcome measurement was for overall.||||0.158
72555701|NCT02558491|144642700|OTHER|||||||0.085||||||No a priori sample size was determined due to the feasibility/pilot nature of the trial. Significance level was set at P-value \<0.05.|Wilcoxon (Mann-Whitney)|||Secondary analysis followed the same format unless variables could not be considered normally distributed; in that case a related samples Wilcoxon signed-rank test is used. Data were first binned (to ensure minimum count of five per bins) and the w2 statistics was used with the expected counts given by SoC. Based on achieved recruitment, a moderate effect size (0.3) is detectable with 80% power, or a large effect size (0.4) with 95% power (G-Power 3.1.9.2). Outcome measurement was for mealtime.||||0.085
72555702|NCT02558491|144642700|OTHER|||||||0.055||||||No a priori sample size was determined due to the feasibility/pilot nature of the trial. Significance level was set at P-value \<0.05.|Wilcoxon (Mann-Whitney)|||Secondary analysis followed the same format unless variables could not be considered normally distributed; in that case a related samples Wilcoxon signed-rank test is used. Data were first binned (to ensure minimum count of five per bins) and the w2 statistics was used with the expected counts given by SoC. Based on achieved recruitment, a moderate effect size (0.3) is detectable with 80% power, or a large effect size (0.4) with 95% power (G-Power 3.1.9.2). Outcome measurement was for overnight.||||0.055
72618324|NCT00286455|144767674|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.28||||0.539|TWO_SIDED|95.0|-1.16|0.61||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.61|-1.16|0.539
72374966|NCT02312687|144260541|SUPERIORITY||LS Mean|-0.48||||0.8396|TWO_SIDED|95.0|-5.11|4.16||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 120||4.16|-5.11|0.8396
72374967|NCT02312687|144260541|SUPERIORITY||LS Mean|-3.43||||0.2284|TWO_SIDED|95.0|-9.0|2.15||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 144||2.15|-9.00|0.2284
72374968|NCT02312687|144260542|SUPERIORITY||LS Mean|0.57|||||TWO_SIDED|95.0|0.32|0.83||||||Change at Week 24||0.83|0.32|
72374969|NCT02312687|144260542|SUPERIORITY||LS Mean|0.47|||||TWO_SIDED|95.0|0.37|0.56||||||Change at Week 48||0.56|0.37|
72374970|NCT02312687|144260542|SUPERIORITY||LS Mean|0.42|||||TWO_SIDED|95.0|0.28|0.56||||||Change at Week 72||0.56|0.28|
72618325|NCT00286455|144767674|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4||||0.379|TWO_SIDED|95.0|-1.29|0.49||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.49|-1.29|0.379
72374971|NCT02312687|144260542|SUPERIORITY||LS Mean|0.44|||||TWO_SIDED|95.0|0.27|0.6||||||Change at Week 96||0.60|0.27|
72374972|NCT02312687|144260542|SUPERIORITY||LS Mean|0.36|||||TWO_SIDED|95.0|0.23|0.48||||||Change at Week 120||0.48|0.23|
72374973|NCT02312687|144260542|SUPERIORITY||LS Mean|0.47|||||TWO_SIDED|95.0|0.32|0.62||||||Change at Week 144||0.62|0.32|
72555703|NCT02558491|144642701|OTHER|||||||0.744||||||No a priori sample size was determined due to the feasibility/pilot nature of the trial. Significance level was set at P-value \<0.05.|Wilcoxon (Mann-Whitney)|||Secondary analysis followed the same format unless variables could not be considered normally distributed; in that case a related samples Wilcoxon signed-rank test is used. Data were first binned (to ensure minimum count of five per bins) and the w2 statistics was used with the expected counts given by SoC. Based on achieved recruitment, a moderate effect size (0.3) is detectable with 80% power, or a large effect size (0.4) with 95% power (G-Power 3.1.9.2). Outcome measurement was for overall.||||0.744
72555704|NCT02558491|144642701|OTHER|||||||0.248||||||No a priori sample size was determined due to the feasibility/pilot nature of the trial. Significance level was set at P-value \<0.05.|Wilcoxon (Mann-Whitney)|||Secondary analysis followed the same format unless variables could not be considered normally distributed; in that case a related samples Wilcoxon signed-rank test is used. Data were first binned (to ensure minimum count of five per bins) and the w2 statistics was used with the expected counts given by SoC. Based on achieved recruitment, a moderate effect size (0.3) is detectable with 80% power, or a large effect size (0.4) with 95% power (G-Power 3.1.9.2). Outcome measurement was for mealtime.||||0.248
72555705|NCT02558491|144642701|OTHER|||||||0.225||||||No a priori sample size was determined due to the feasibility/pilot nature of the trial. Significance level was set at P-value \<0.05.|Wilcoxon (Mann-Whitney)|||Secondary analysis followed the same format unless variables could not be considered normally distributed; in that case a related samples Wilcoxon signed-rank test is used. Data were first binned (to ensure minimum count of five per bins) and the w2 statistics was used with the expected counts given by SoC. Based on achieved recruitment, a moderate effect size (0.3) is detectable with 80% power, or a large effect size (0.4) with 95% power (G-Power 3.1.9.2). Outcome measurement was for overnight.||||0.225
72555706|NCT02558491|144642702|OTHER|||||||0.86||||||No a priori sample size was determined due to the feasibility/pilot nature of the trial. Significance level was set at P-value \<0.05.|ANOVA|||Secondary analysis followed the same format unless variables could not be considered normally distributed; in that case a related samples Wilcoxon signed-rank test is used. Data were first binned (to ensure minimum count of five per bins) and the w2 statistics was used with the expected counts given by SoC. Based on achieved recruitment, a moderate effect size (0.3) is detectable with 80% power, or a large effect size (0.4) with 95% power (G-Power 3.1.9.2). Outcome measurement was for overall.||||0.86
72555707|NCT02558491|144642702|OTHER|||||||0.522||||||No a priori sample size was determined due to the feasibility/pilot nature of the trial. Significance level was set at P-value \<0.05.|ANOVA|||Secondary analysis followed the same format unless variables could not be considered normally distributed; in that case a related samples Wilcoxon signed-rank test is used. Data were first binned (to ensure minimum count of five per bins) and the w2 statistics was used with the expected counts given by SoC. Based on achieved recruitment, a moderate effect size (0.3) is detectable with 80% power, or a large effect size (0.4) with 95% power (G-Power 3.1.9.2). Outcome measurement was for mealtime.||||0.522
72555708|NCT02558491|144642702|OTHER|||||||0.522||||||No a priori sample size was determined due to the feasibility/pilot nature of the trial. Significance level was set at P-value \<0.05.|ANOVA|||Secondary analysis followed the same format unless variables could not be considered normally distributed; in that case a related samples Wilcoxon signed-rank test is used. Data were first binned (to ensure minimum count of five per bins) and the w2 statistics was used with the expected counts given by SoC. Based on achieved recruitment, a moderate effect size (0.3) is detectable with 80% power, or a large effect size (0.4) with 95% power (G-Power 3.1.9.2). Outcome measurement was for overnight.||||0.522
72555709|NCT02558491|144642703|OTHER|||||||0.301||||||No a priori sample size was determined due to the feasibility/pilot nature of the trial. Significance level was set at P-value \<0.05.|ANOVA|||Secondary analysis followed the same format unless variables could not be considered normally distributed; in that case a related samples Wilcoxon signed-rank test is used. Data were first binned (to ensure minimum count of five per bins) and the w2 statistics was used with the expected counts given by SoC. Based on achieved recruitment, a moderate effect size (0.3) is detectable with 80% power, or a large effect size (0.4) with 95% power (G-Power 3.1.9.2). Outcome measurement was for overall.||||0.301
72555710|NCT02558491|144642704|OTHER|||||||0.189||||||No a priori sample size was determined due to the feasibility/pilot nature of the trial. Significance level was set at P-value \<0.05.|ANOVA|||Secondary analysis followed the same format unless variables could not be considered normally distributed; in that case a related samples Wilcoxon signed-rank test is used. Data were first binned (to ensure minimum count of five per bins) and the w2 statistics was used with the expected counts given by SoC. Based on achieved recruitment, a moderate effect size (0.3) is detectable with 80% power, or a large effect size (0.4) with 95% power (G-Power 3.1.9.2). Outcome measurement was for overall.||||0.189
72555711|NCT02558491|144642705|OTHER|||||||0.271||||||No a priori sample size was determined due to the feasibility/pilot nature of the trial. Significance level was set at P-value \<0.05.|ANOVA|||Secondary analysis followed the same format unless variables could not be considered normally distributed; in that case a related samples Wilcoxon signed-rank test is used. Data were first binned (to ensure minimum count of five per bins) and the w2 statistics was used with the expected counts given by SoC. Based on achieved recruitment, a moderate effect size (0.3) is detectable with 80% power, or a large effect size (0.4) with 95% power (G-Power 3.1.9.2). Outcome measurement was for overall.||||0.271
72555712|NCT00834431|144642708|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|92.0||||||90.0|85.9|98.6|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||98.6|85.9|
72555713|NCT00834431|144642709|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|98.6||||||90.0|96.2|101.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||101|96.2|
72374974|NCT02312687|144260543|SUPERIORITY||LS Mean|0.04|||||TWO_SIDED|95.0|0.01|0.07||||||Change at Week 24||0.07|0.01|
72374975|NCT02312687|144260543|SUPERIORITY||LS Mean|0.01|||||TWO_SIDED|95.0|-0.01|0.03||||||Change at Week 48||0.03|-0.01|
72374976|NCT02312687|144260543|SUPERIORITY||LS Mean|0.01|||||TWO_SIDED|95.0|-0.01|0.04||||||Change at Week 72||0.04|-0.01|
72374977|NCT02312687|144260543|SUPERIORITY||LS Mean|0.05|||||TWO_SIDED|95.0|0.02|0.07||||||Change at Week 96||0.07|0.02|
72374978|NCT02312687|144260543|SUPERIORITY||LS Mean|0.01|||||TWO_SIDED|95.0|-0.02|0.03||||||Change at Week 120||0.03|-0.02|
72374979|NCT02312687|144260543|SUPERIORITY||LS Mean|0.02|||||TWO_SIDED|95.0|-0.01|0.05||||||Change at Week 144||0.05|-0.01|
72374980|NCT02312687|144260544|SUPERIORITY||LS Mean|-0.04|||||TWO_SIDED|95.0|-0.07|-0.01||||||Change at Week 24||-0.01|-0.07|
72374981|NCT02312687|144260544|SUPERIORITY||LS Mean|-0.01|||||TWO_SIDED|95.0|-0.03|0.01||||||Change at Week 48||0.01|-0.03|
72374982|NCT02312687|144260544|SUPERIORITY||LS Mean|-0.01|||||TWO_SIDED|95.0|-0.04|0.01||||||Change at Week 72||0.01|-0.04|
72374983|NCT02312687|144260544|SUPERIORITY||LS Mean|-0.05|||||TWO_SIDED|95.0|-0.07|-0.02||||||Change at Week 96||-0.02|-0.07|
72374984|NCT02312687|144260544|SUPERIORITY||LS Mean|-0.01|||||TWO_SIDED|95.0|-0.03|0.02||||||Change at Week 120||0.02|-0.03|
72374985|NCT02312687|144260544|SUPERIORITY||LS Mean|-0.02|||||TWO_SIDED|95.0|-0.05|0.01||||||Change at Week 144||0.01|-0.05|
72374986|NCT02312687|144260545|SUPERIORITY||LS Mean|-0.01|||||TWO_SIDED|95.0|-0.1|0.08||||||Change at Week 24||0.08|-0.10|
72374987|NCT02312687|144260545|SUPERIORITY||LS Mean|0.02|||||TWO_SIDED|95.0|-0.07|0.1||||||Change at Week 48||0.10|-0.07|
72374988|NCT02312687|144260545|SUPERIORITY||LS Mean|0.08|||||TWO_SIDED|95.0|-0.01|0.16||||||Change at Week 72||0.16|-0.01|
72374989|NCT02312687|144260545|SUPERIORITY||LS Mean|-0.01|||||TWO_SIDED|95.0|-0.09|0.06||||||Change at Week 96||0.06|-0.09|
72374990|NCT02312687|144260545|SUPERIORITY||LS Mean|-0.01|||||TWO_SIDED|95.0|-0.12|0.1||||||Change at Week 120||0.10|-0.12|
72374991|NCT02312687|144260545|SUPERIORITY||LS Mean|-0.05|||||TWO_SIDED|95.0|-0.16|0.06||||||Change at Week 144||0.06|-0.16|
72374992|NCT02312687|144260546|SUPERIORITY||LS Mean|22.89|||||TWO_SIDED|95.0|-1.81|47.6||||||Change at Week 24||47.60|-1.81|
72374993|NCT02312687|144260546|SUPERIORITY||LS Mean|15.15|||||TWO_SIDED|95.0|-2.32|32.62||||||Change at Week 48||32.62|-2.32|
72374994|NCT02312687|144260546|SUPERIORITY||LS Mean|11.1|||||TWO_SIDED|95.0|-14.33|36.53||||||Change at Week 72||36.53|-14.33|
72374995|NCT02312687|144260546|SUPERIORITY||LS Mean|-16.65|||||TWO_SIDED|95.0|-37.5|4.2||||||Change at Week 96||4.20|-37.50|
72374996|NCT02312687|144260546|SUPERIORITY||LS Mean|3.48|||||TWO_SIDED|95.0|-32.53|39.49||||||Change at Week 120||39.49|-32.53|
72374997|NCT02312687|144260546|SUPERIORITY||LS Mean|28.55|||||TWO_SIDED|95.0|-11.12|68.22||||||Change at Week 144||68.22|-11.12|
72374998|NCT02312687|144260547|SUPERIORITY||LS Mean|-14.77|||||TWO_SIDED|95.0|-87.62|58.08||||||Change at Week 24||58.08|-87.62|
72374999|NCT02312687|144260547|SUPERIORITY||LS Mean|-70.79|||||TWO_SIDED|95.0|-161.31|19.74||||||Change at Week 48||19.74|-161.31|
72375000|NCT02312687|144260547|SUPERIORITY||LS Mean|-16.11|||||TWO_SIDED|95.0|-110.96|78.73||||||Change at Week 72||78.73|-110.96|
72375001|NCT02312687|144260547|SUPERIORITY||LS Mean|-41.74|||||TWO_SIDED|95.0|-150.61|67.13||||||Change at Week 96||67.13|-150.61|
72375002|NCT02312687|144260547|SUPERIORITY||LS Mean|-76.11|||||TWO_SIDED|95.0|-237.29|85.08||||||Change at Week 120||85.08|-237.29|
72375003|NCT02312687|144260547|SUPERIORITY||LS Mean|-96.06|||||TWO_SIDED|95.0|-206.59|14.46||||||Change at Week 144||14.46|-206.59|
72375004|NCT02312687|144260548|SUPERIORITY||LS Mean|0.01|||||TWO_SIDED|95.0|-0.01|0.03||||||Change at Week 24||0.03|-0.01|
72375005|NCT02312687|144260548|SUPERIORITY||LS Mean|0.01|||||TWO_SIDED|95.0|-0.01|0.04||||||Change at Week 48||0.04|-0.01|
72375006|NCT02312687|144260548|SUPERIORITY||LS Mean|0.0|||||TWO_SIDED|95.0|-0.02|0.02||||||Change at Week 72||0.02|-0.02|
72375007|NCT02312687|144260548|SUPERIORITY||LS Mean|-0.01|||||TWO_SIDED|95.0|-0.04|0.02||||||Change at Week 96||0.02|-0.04|
72375008|NCT02312687|144260548|SUPERIORITY||LS Mean|0.0|||||TWO_SIDED|95.0|-0.02|0.03||||||Change at Week 120||0.03|-0.02|
72375009|NCT02312687|144260548|SUPERIORITY||LS Mean|0.03|||||TWO_SIDED|95.0|-0.01|0.08||||||Change at Week 144||0.08|-0.01|
72375010|NCT02312687|144260549|SUPERIORITY||LS Mean|14.92||||0.0314|TWO_SIDED|95.0|1.33|28.52||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 24||28.52|1.33|0.0314
72375011|NCT02312687|144260549|SUPERIORITY||LS Mean|-1.73||||0.764|TWO_SIDED|95.0|-13.0|9.55||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 48||9.55|-13.00|0.7640
72375012|NCT02312687|144260549|SUPERIORITY||LS Mean|-22.28|||<|0.0001|TWO_SIDED|95.0|-30.2|-14.35||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 72||-14.35|-30.20|< 0.0001
72375013|NCT02312687|144260549|SUPERIORITY||LS Mean|-20.93|||<|0.0001|TWO_SIDED|95.0|-27.92|-13.94||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 96||-13.94|-27.92|< 0.0001
72375014|NCT02312687|144260549|SUPERIORITY||LS Mean|-18.77||||0.0094|TWO_SIDED|95.0|-32.93|-4.6||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 120||-4.60|-32.93|0.0094
72375015|NCT02312687|144260549|SUPERIORITY||LS Mean|-25.72|||<|0.0001|TWO_SIDED|95.0|-36.89|-14.54||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 144||-14.54|-36.89|< 0.0001
72375016|NCT02312687|144260550|SUPERIORITY||LS Mean|4.68||||0.1673|TWO_SIDED|95.0|-1.96|11.32||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 24||11.32|-1.96|0.1673
72375017|NCT02312687|144260550|SUPERIORITY||LS Mean|-2.68||||0.233|TWO_SIDED|95.0|-7.09|1.72||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 48||1.72|-7.09|0.2330
72375018|NCT02312687|144260550|SUPERIORITY||LS Mean|-7.45|||<|0.0001|TWO_SIDED|95.0|-9.54|-5.36||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 72||-5.36|-9.54|< 0.0001
72375019|NCT02312687|144260550|SUPERIORITY||LS Mean|-8.08|||<|0.0001|TWO_SIDED|95.0|-9.86|-6.29||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 96||-6.29|-9.86|< 0.0001
72375020|NCT02312687|144260550|SUPERIORITY||LS Mean|-10.01|||<|0.0001|TWO_SIDED|95.0|-13.07|-6.95||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 120||-6.95|-13.07|< 0.0001
72375021|NCT02312687|144260550|SUPERIORITY||LS Mean|-10.89|||<|0.0001|TWO_SIDED|95.0|-14.77|-7.02||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 144||-7.02|-14.77|< 0.0001
72375022|NCT02312687|144260551|SUPERIORITY||LS Mean|343.38||||0.0113|TWO_SIDED|95.0|77.66|609.11||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 24||609.11|77.66|0.0113
72375023|NCT02312687|144260551|SUPERIORITY||LS Mean|41.45||||0.4972|TWO_SIDED|95.0|-78.23|161.13||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 48||161.13|-78.23|0.4972
72375024|NCT02312687|144260551|SUPERIORITY||LS Mean|-61.96||||0.3288|TWO_SIDED|95.0|-186.34|62.41||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 72||62.41|-186.34|0.3288
72375025|NCT02312687|144260551|SUPERIORITY||LS Mean|-68.62||||0.2772|TWO_SIDED|95.0|-192.39|55.16||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 96||55.16|-192.39|0.2772
72375026|NCT02312687|144260551|SUPERIORITY||LS Mean|-53.41||||0.2907|TWO_SIDED|95.0|-152.47|45.66||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 120||45.66|-152.47|0.2907
72375027|NCT02312687|144260551|SUPERIORITY||LS Mean|-97.46||||0.08|TWO_SIDED|95.0|-206.57|11.65||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 144||11.65|-206.57|0.0800
72375028|NCT02312687|144260552|SUPERIORITY||LS Mean|72.45|||<|0.0001|TWO_SIDED|95.0|39.21|105.7||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 24||105.70|39.21|< 0.0001
72504929|NCT02747043|144540916|OTHER||Risk Difference (RD)|0.9|||||TWO_SIDED|95.0|-11.3|13.2||||||The 2-sided 95% confidence limits of the risk difference (RD) of ORR at week 12 used a generalized linear model adjusted for the stratification factors (geographic region and age group).||13.2|-11.3|
72375029|NCT02312687|144260552|SUPERIORITY||LS Mean|44.4|||<|0.0001|TWO_SIDED|95.0|30.34|58.47||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 48||58.47|30.34|< 0.0001
72375030|NCT02312687|144260552|SUPERIORITY||LS Mean|28.3||||0.0002|TWO_SIDED|95.0|13.24|43.37||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 72||43.37|13.24|0.0002
72375031|NCT02312687|144260552|SUPERIORITY||LS Mean|27.02|||<|0.0001|TWO_SIDED|95.0|13.81|40.22||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 96||40.22|13.81|< 0.0001
72375032|NCT02312687|144260552|SUPERIORITY||LS Mean|13.02||||0.1195|TWO_SIDED|95.0|-3.37|29.4||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 120||29.40|-3.37|0.1195
72375033|NCT02312687|144260552|SUPERIORITY||LS Mean|43.12||||0.2009|TWO_SIDED|95.0|-22.96|109.2||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 144||109.20|-22.96|0.2009
72375034|NCT00223236|144260649|SUPERIORITY_OR_OTHER|||||||0.4637|||||||Chi-squared|df=1 n=34||Null hypothsis is no group association in cocaine use.||||.4637
72375035|NCT01181986|144260653|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|Adjusted for treatment sequence, group (diabetes duration) and time.||||||<0.0001
72375036|NCT01181986|144260653|SUPERIORITY_OR_OTHER|||||||0.006|||||||ANCOVA|Adjusted for treatment sequence.||||||0.006
72375037|NCT01181986|144260653|SUPERIORITY_OR_OTHER|||||||0.003|||||||ANCOVA|Adjusted for treatment sequence.||||||0.003
72375038|NCT01181986|144260654|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|Adjusted for treatment sequence and diabetes duration group.||||||<0.0001
72375039|NCT01181986|144260655|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|||||||<0.0001
72375040|NCT03720652|144260658|OTHER|The statistical test is a paired test assessing change at the End-of-Intervention Interview relative to baseline.||||||0.18|||||||McNemar|||As the study design is quasi-experimental, there is no comparison group - both arms were analyzed jointly for each pre- and post- time interval.||||0.18
72375041|NCT03720652|144260658|OTHER|The statistical test is a paired test assessing change at the 3-Month Follow Up Interview relative to baseline.||||||0.34|||||||McNemar|||As the study design is quasi-experimental, there is no comparison group - both arms were analyzed jointly for each pre- and post- time interval.||||0.34
72395080|NCT00720434|144296638|SUPERIORITY_OR_OTHER||Difference in Proportions|0.0|||||TWO_SIDED|95.0|-0.507|0.507||||||Week 60: The difference in proportions between treatment groups presented along with 95% CI, were based on exact method for small samples from the binomial distribution.||0.5070|-0.5070|
72375042|NCT03720652|144260658|OTHER|The statistical test is a paired test assessing change at the 6-Month Follow Up Interview relative to baseline.||||||0.13|||||||McNemar|||As the study design is quasi-experimental, there is no comparison group - both arms were analyzed jointly for each pre- and post- time interval.||||0.13
72375043|NCT03720652|144260659|OTHER|The statistical test is a paired test assessing change at the End-of-Intervention Interview relative to baseline.||||||0.7|||||||Wilcoxon (Mann-Whitney)|||As the study design is quasi-experimental, there is no comparison group - both arms were analyzed jointly for each pre- and post- time interval.||||0.70
72375044|NCT03720652|144260659|OTHER|The statistical test is a paired test assessing change at the 3-Month Follow Up Interview relative to baseline.||||||0.66|||||||Wilcoxon (Mann-Whitney)|||As the study design is quasi-experimental, there is no comparison group - both arms were analyzed jointly for each pre- and post- time interval.||||0.66
72395081|NCT00720434|144296638|SUPERIORITY_OR_OTHER||Difference in Proportions|-0.2|||||TWO_SIDED|95.0|-0.6191|0.2811||||||Week 60: The difference in proportions between treatment groups presented along with 95% CI, were based on exact method for small samples from the binomial distribution.||0.2811|-0.6191|
72395082|NCT00720434|144296638|SUPERIORITY_OR_OTHER||Difference in Proportions|0.0|||||TWO_SIDED|95.0|-0.507|0.507||||||Week 60: The difference in proportions between treatment groups presented along with 95% CI, were based on exact method for small samples from the binomial distribution.||0.5070|-0.5070|
72395083|NCT00720434|144296638|SUPERIORITY_OR_OTHER||Difference in Proportions|-0.2|||||TWO_SIDED|95.0|-0.6191|0.2811||||||Week 60: The difference in proportions between treatment groups presented along with 95% CI, were based on exact method for small samples from the binomial distribution.||0.2811|-0.6191|
72395084|NCT00720434|144296638|SUPERIORITY_OR_OTHER||Difference in Proportions|-0.2|||||TWO_SIDED|95.0|-0.6191|0.2811||||||Week 72: The difference in proportions between treatment groups presented along with 95% CI, were based on exact method for small samples from the binomial distribution.||0.2811|-0.6191|
72395085|NCT00720434|144296638|SUPERIORITY_OR_OTHER||Difference in Proportions|0.0|||||TWO_SIDED|95.0|-0.507|0.507||||||Week 72: The difference in proportions between treatment groups presented along with 95% CI, were based on exact method for small samples from the binomial distribution.||0.5070|-0.5070|
72375045|NCT03720652|144260659|OTHER|The statistical test is a paired test assessing change at the 6-Month Follow Up Interview relative to baseline.||||||0.84|||||||Wilcoxon (Mann-Whitney)|||As the study design is quasi-experimental, there is no comparison group - both arms were analyzed jointly for each pre- and post- time interval.||||0.84
72375046|NCT03720652|144260660|OTHER|The statistical test is a paired test assessing change at the End-of-Intervention Interview relative to baseline.||||||0.015|||||||Wilcoxon (Mann-Whitney)|||As the study design is quasi-experimental, there is no comparison group - both arms were analyzed jointly for each pre- and post- time interval.||||0.015
72375047|NCT03720652|144260660|OTHER|The statistical test is a paired test assessing change at the 3-Month Follow Up Interview relative to baseline.||||||0.34|||||||Wilcoxon (Mann-Whitney)|||As the study design is quasi-experimental, there is no comparison group - both arms were analyzed jointly for each pre- and post- time interval.||||0.34
72375048|NCT03720652|144260660|OTHER|The statistical test is a paired test assessing change at the End-of-Program Interview relative to baseline.||||||0.002|||||||Wilcoxon (Mann-Whitney)|||As the study design is quasi-experimental, there is no comparison group - both arms were analyzed jointly for each pre- and post- time interval.||||0.002
72375049|NCT03720652|144260661|OTHER|The statistical test is a paired test assessing change at the End-of-Intervention Interview relative to baseline.||||||0.022|||||||Wilcoxon (Mann-Whitney)|||As the study design is quasi-experimental, there is no comparison group - both arms were analyzed jointly for each pre- and post- time interval.||||0.022
72375050|NCT03720652|144260661|OTHER|The statistical test is a paired test assessing change at the 3-Month Follow Up Interview relative to baseline.||||||0.02|||||||Wilcoxon (Mann-Whitney)|||As the study design is quasi-experimental, there is no comparison group - both arms were analyzed jointly for each pre- and post- time interval.||||0.020
72375051|NCT03720652|144260661|OTHER|The statistical test is a paired test assessing change at the 6-Month Follow Up Interview relative to baseline.||||||0.09|||||||Wilcoxon (Mann-Whitney)|||As the study design is quasi-experimental, there is no comparison group - both arms were analyzed jointly for each pre- and post- time interval.||||0.090
72555714|NCT00834431|144642710|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|98.7||||||90.0|96.3|101.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||101|96.3|
72555715|NCT01020474|144642743|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.66||||0.121|TWO_SIDED|95.0|-1.51|0.18||Missing data for week 15 mean pain score are imputed based on distribution of baseline pain scores if participants discontinue due to adverse events/ abnormal laboratory test results or lack of efficacy.|ANCOVA|Based on LS Means using analysis of covariance (ANCOVA) model (including Treatment, Center, Baseline value as covariate).||||0.18|-1.51|0.121
72375052|NCT03720652|144260662|OTHER|The statistical test is a paired test assessing change at the End-of-Intervention Interview relative to baseline.||||||0.051|||||||Wilcoxon (Mann-Whitney)|||As the study design is quasi-experimental, there is no comparison group - both arms were analyzed jointly for each pre- and post- time interval.||||0.051
72375053|NCT03720652|144260662|OTHER|The statistical test is a paired test assessing change at the 3-Month Follow Up Interview relative to baseline.||||||0.044|||||||Wilcoxon (Mann-Whitney)|||As the study design is quasi-experimental, there is no comparison group - both arms were analyzed jointly for each pre- and post- time interval.||||0.044
72375054|NCT03720652|144260662|OTHER|The statistical test is a paired test assessing change at the 6-Month Follow Up Interview relative to baseline.||||||1|||||||Wilcoxon (Mann-Whitney)|||As the study design is quasi-experimental, there is no comparison group - both arms were analyzed jointly for each pre- and post- time interval.||||1.00
72433541|NCT04888585|144380260|SUPERIORITY||Response Rate Difference|19.5|||<|0.001|TWO_SIDED|95.0|8.7|30.2|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted for the stratification factors.|Response Rate Difference = ABBV-154 150mg EOW - Placebo|||30.2|8.7|<0.001
72375055|NCT03720652|144260663|OTHER|The statistical test is a paired test assessing change at the End-of-Intervention Interview relative to baseline.||||||0.023|||||||Wilcoxon (Mann-Whitney)|||As the study design is quasi-experimental, there is no comparison group - both arms were analyzed jointly for each pre- and post- time interval.||||0.023
72375056|NCT03720652|144260663|OTHER|The statistical test is a paired test assessing change at the 3-Month Follow Up Interview relative to baseline.||||||0.56|||||||Wilcoxon (Mann-Whitney)|||As the study design is quasi-experimental, there is no comparison group - both arms were analyzed jointly for each pre- and post- time interval.||||0.56
72375057|NCT03720652|144260663|OTHER|The statistical test is a paired test assessing change at the 6-Month Follow Up Interview relative to baseline.||||||0.16|||||||Wilcoxon (Mann-Whitney)|||As the study design is quasi-experimental, there is no comparison group - both arms were analyzed jointly for each pre- and post- time interval.||||0.16
72375058|NCT03720652|144260664|OTHER|The statistical test is a paired test assessing change at the End-of-Intervention Interview relative to baseline.||||||0.15|||||||Wilcoxon (Mann-Whitney)|||As the study design is quasi-experimental, there is no comparison group - both arms were analyzed jointly for each pre- and post- time interval.||||0.15
72375059|NCT03720652|144260664|OTHER|The statistical test is a paired test assessing change at the 3-Month Follow Up Interview relative to baseline.||||||0.12|||||||Wilcoxon (Mann-Whitney)|||As the study design is quasi-experimental, there is no comparison group - both arms were analyzed jointly for each pre- and post- time interval.||||0.12
72375060|NCT03720652|144260664|OTHER|The statistical test is a paired test assessing change at the 6-Month Follow Up Interview relative to baseline.||||||0.018|||||||Wilcoxon (Mann-Whitney)|||As the study design is quasi-experimental, there is no comparison group - both arms were analyzed jointly for each pre- and post- time interval.||||0.018
72375061|NCT03720652|144260665|OTHER|The statistical test is a paired test assessing change at the End-of-Intervention Interview relative to baseline.||||||0.33|||||||Wilcoxon (Mann-Whitney)|||As the study design is quasi-experimental, there is no comparison group - both arms were analyzed jointly for each pre- and post- time interval.||||0.33
72375062|NCT03720652|144260665|OTHER|The statistical test is a paired test assessing change at the 3-Month Follow Up Interview relative to baseline.||||||0.88|||||||Wilcoxon (Mann-Whitney)|||As the study design is quasi-experimental, there is no comparison group - both arms were analyzed jointly for each pre- and post- time interval.||||0.88
72375063|NCT03720652|144260665|OTHER|The statistical test is a paired test assessing change at the 6-Month Follow Up Interview relative to baseline.||||||0.67|||||||Wilcoxon (Mann-Whitney)|||As the study design is quasi-experimental, there is no comparison group - both arms were analyzed jointly for each pre- and post- time interval.||||0.67
72375064|NCT03720652|144260666|OTHER|The statistical test is a paired test assessing change at the End-of-Intervention Interview relative to baseline.|||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||As the study design is quasi-experimental, there is no comparison group - both arms were analyzed jointly for each pre- and post- time interval.||||<0.001
72375065|NCT03720652|144260666|OTHER|The statistical test is a paired test assessing change at the 3-Month Follow Up Interview relative to baseline.|||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||As the study design is quasi-experimental, there is no comparison group - both arms were analyzed jointly for each pre- and post- time interval.||||<0.001
72555716|NCT01020474|144642744|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.18||||0.655|TWO_SIDED|95.0|-1.0|0.63|||ANCOVA|Based on LS Means using analysis of covariance (ANCOVA) model (including Treatment, Center, Baseline value as covariate).||||0.63|-1.00|0.655
72555717|NCT01020474|144642745|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.07||||0.842|TWO_SIDED|95.0|-0.75|0.61|||Mixed Models Analysis|||Statistical analysis of Week 1.||0.61|-0.75|0.842
72555718|NCT01020474|144642745|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.63||||0.07|TWO_SIDED|95.0|-1.32|0.05|||Mixed Models Analysis|||Statistical analysis of Week 2||0.05|-1.32|0.070
72618326|NCT00286455|144767675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.5||||0.616|TWO_SIDED|95.0|-4.4|7.5||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||7.5|-4.4|0.616
72618327|NCT00286455|144767675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3||||0.93|TWO_SIDED|95.0|-6.4|5.8||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||5.8|-6.4|0.930
72618328|NCT00286455|144767676|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3||||0.915|TWO_SIDED|95.0|-5.3|6.0||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||6.0|-5.3|0.915
72618329|NCT00286455|144767676|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.0||||0.745|TWO_SIDED|95.0|-4.8|6.7||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||6.7|-4.8|0.745
72618330|NCT00286455|144767677|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.0||||0.466|TWO_SIDED|95.0|-3.4|7.5||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||7.5|-3.4|0.466
72618331|NCT00286455|144767677|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.0||||0.154|TWO_SIDED|95.0|-1.5|9.6||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||9.6|-1.5|0.154
72618332|NCT00286455|144767678|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.9||||0.774|TWO_SIDED|95.0|-5.1|6.9||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||6.9|-5.1|0.774
72618333|NCT00286455|144767678|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.9||||0.761|TWO_SIDED|95.0|-5.2|7.1||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||7.1|-5.2|0.761
72618334|NCT00286455|144767679|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.8||||0.559|TWO_SIDED|95.0|-4.2|7.7||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||7.7|-4.2|0.559
72618335|NCT00286455|144767679|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.0||||0.523|TWO_SIDED|95.0|-4.1|8.0||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||8.0|-4.1|0.523
72618336|NCT00286455|144767680|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.1||||0.739|TWO_SIDED|95.0|-7.4|5.2||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||5.2|-7.4|0.739
72375066|NCT03720652|144260666|OTHER|The statistical test is a paired test assessing change at the 6-Month Follow Up Interview relative to baseline.|||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||As the study design is quasi-experimental, there is no comparison group - both arms were analyzed jointly for each pre- and post- time interval.||||<0.001
72375067|NCT03720652|144260667|OTHER|The statistical test is a paired test assessing change at the End-of-Intervention Interview relative to baseline.||||||0.17|||||||Wilcoxon (Mann-Whitney)|||As the study design is quasi-experimental, there is no comparison group - both arms were analyzed jointly for each pre- and post- time interval.||||0.17
72375068|NCT03720652|144260667|OTHER|The statistical test is a paired test assessing change at the 3-Month Follow Up Interview relative to baseline.||||||0.02|||||||Wilcoxon (Mann-Whitney)|||As the study design is quasi-experimental, there is no comparison group - both arms were analyzed jointly for each pre- and post- time interval.||||0.020
72375069|NCT03720652|144260667|OTHER|The statistical test is a paired test assessing change at the 6-Month Follow Up Interview relative to baseline.||||||0.062|||||||Wilcoxon (Mann-Whitney)|||As the study design is quasi-experimental, there is no comparison group - both arms were analyzed jointly for each pre- and post- time interval.||||0.062
72375070|NCT03720652|144260668|OTHER|The statistical test is a paired test assessing change at the End-of-Intervention Interview relative to baseline.||||||0.013|||||||Wilcoxon (Mann-Whitney)|||As the study design is quasi-experimental, there is no comparison group - both arms were analyzed jointly for each pre- and post- time interval.||||0.013
72375071|NCT03720652|144260668|OTHER|The statistical test is a paired test assessing change at the 3-Month Follow Up Interview relative to baseline.||||||0.001|||||||Wilcoxon (Mann-Whitney)|||As the study design is quasi-experimental, there is no comparison group - both arms were analyzed jointly for each pre- and post- time interval.||||0.001
72375072|NCT03720652|144260668|OTHER|The statistical test is a paired test assessing change at the 6-Month Follow Up Interview relative to baseline.||||||0.003|||||||Wilcoxon (Mann-Whitney)|||As the study design is quasi-experimental, there is no comparison group - both arms were analyzed jointly for each pre- and post- time interval.||||0.003
72375073|NCT03720652|144260669|OTHER|The statistical test is a paired test assessing change at the End-of-Intervention Interview relative to baseline.||||||0.001|||||||Wilcoxon (Mann-Whitney)|||As the study design is quasi-experimental, there is no comparison group - both arms were analyzed jointly for each pre- and post- time interval.||||0.001
72555719|NCT01020474|144642745|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.83||||0.019|TWO_SIDED|95.0|-1.51|-0.14|||Mixed Models Analysis|||Statistical analysis of Week 3.||-0.14|-1.51|0.019
72555720|NCT01020474|144642745|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.9||||0.011|TWO_SIDED|95.0|-1.59|-0.21|||Mixed Models Analysis|||Statistical analysis of Week 4.||-0.21|-1.59|0.011
72375074|NCT03720652|144260669|OTHER|The statistical test is a paired test assessing change at the 3-Month Follow Up Interview relative to baseline.||||||0.01|||||||Wilcoxon (Mann-Whitney)|||As the study design is quasi-experimental, there is no comparison group - both arms were analyzed jointly for each pre- and post- time interval.||||0.010
72375075|NCT03720652|144260669|OTHER|The statistical test is a paired test assessing change at the 6-Month Follow Up Interview relative to baseline.||||||0.085|||||||Wilcoxon (Mann-Whitney)|||As the study design is quasi-experimental, there is no comparison group - both arms were analyzed jointly for each pre- and post- time interval.||||0.085
72375076|NCT03720652|144260670|OTHER|The statistical test is a paired test assessing change at the End-of-Intervention Interview relative to baseline.|||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||As the study design is quasi-experimental, there is no comparison group - both arms were analyzed jointly for each pre- and post- time interval.||||<0.001
72375077|NCT03720652|144260670|OTHER|The statistical test is a paired test assessing change at the 3-Month Follow Up Interview relative to baseline.|||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||As the study design is quasi-experimental, there is no comparison group - both arms were analyzed jointly for each pre- and post- time interval.||||<0.001
72375078|NCT03720652|144260670|OTHER|The statistical test is a paired test assessing change at the 6-Month Follow Up Interview relative to baseline.|||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||As the study design is quasi-experimental, there is no comparison group - both arms were analyzed jointly for each pre- and post- time interval.||||<0.001
72375079|NCT03720652|144260671|OTHER|The statistical test is a paired test assessing change at the End-of-Intervention Interview relative to baseline.||||||0.046|||||||Wilcoxon (Mann-Whitney)|||As the study design is quasi-experimental, there is no comparison group - both arms were analyzed jointly for each pre- and post- time interval.||||0.046
72375080|NCT03720652|144260671|OTHER|The statistical test is a paired test assessing change at the 3-Month Follow Up Interview relative to baseline.||||||0.14|||||||Wilcoxon (Mann-Whitney)|||As the study design is quasi-experimental, there is no comparison group - both arms were analyzed jointly for each pre- and post- time interval.||||0.14
72375081|NCT03720652|144260671|OTHER|The statistical test is a paired test assessing change at the 6-Month Follow Up Interview relative to baseline.||||||0.058|||||||Wilcoxon (Mann-Whitney)|||As the study design is quasi-experimental, there is no comparison group - both arms were analyzed jointly for each pre- and post- time interval.||||0.058
72375082|NCT03720652|144260672|OTHER|The statistical test is a paired test assessing change at the End-of-Intervention Interview relative to baseline.|||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||As the study design is quasi-experimental, there is no comparison group - both arms were analyzed jointly for each pre- and post- time interval.||||<0.001
72375083|NCT03720652|144260672|OTHER|The statistical test is a paired test assessing change at the 3-Month Follow Up Interview relative to baseline.|||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||As the study design is quasi-experimental, there is no comparison group - both arms were analyzed jointly for each pre- and post- time interval.||||<0.001
72555721|NCT01020474|144642745|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.68||||0.056|TWO_SIDED|95.0|-1.38|0.02|||Mixed Models Analysis|||Statistical analysis of Week 5.||0.02|-1.38|0.056
72555722|NCT01020474|144642745|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.96||||0.008|TWO_SIDED|95.0|-1.66|-0.26|||Mixed Models Analysis|||Statistical analysis of Week 6.||-0.26|-1.66|0.008
72555723|NCT01020474|144642745|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.89||||0.013|TWO_SIDED|95.0|-1.6|-0.19|||Mixed Models Analysis|||Statistical analysis of Week 7.||-0.19|-1.60|0.013
72555724|NCT01020474|144642745|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.06||||0.004|TWO_SIDED|95.0|-1.77|-0.35|||Mixed Models Analysis|||Statistical analysis of Week 8.||-0.35|-1.77|0.004
72555725|NCT01020474|144642745|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-0.95||||0.009|TWO_SIDED|95.0|-1.67|-0.24|||Mixed Models Analysis|||Statistical analysis of Week 9.||-0.24|-1.67|0.009
72375084|NCT03720652|144260672|OTHER|The statistical test is a paired test assessing change at the 6-Month Follow Up Interview relative to baseline.|||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||As the study design is quasi-experimental, there is no comparison group - both arms were analyzed jointly for each pre- and post- time interval.||||<0.001
72375085|NCT03073733|144260679|SUPERIORITY||least squares mean difference|-2.2|STANDARD_ERROR_OF_MEAN|2.9||0.582|TWO_SIDED|95.0|-10.3|5.8|||linear model for repeated measures|||||5.8|-10.3|0.582
72375086|NCT03073733|144260679|SUPERIORITY||least squares mean difference|-0.1|STANDARD_ERROR_OF_MEAN|2.91||0.984|TWO_SIDED|95.0|-8.2|8.0|||linear model for repeated measures|||||8.0|-8.2|0.984
72375087|NCT03073733|144260680|SUPERIORITY||least squares mean difference|1.2986|STANDARD_ERROR_OF_MEAN|0.8744||0.29|TWO_SIDED|95.0|-1.1341|3.7313|||linear model for repeated measures|||||3.7313|-1.1341|0.290
72375088|NCT03073733|144260680|SUPERIORITY||least squares mean difference|-0.3542|STANDARD_ERROR_OF_MEAN|0.7793||0.759|TWO_SIDED|95.0|-2.6516|1.9433|||linear model for repeated measures|||||1.9433|-2.6516|0.759
72375089|NCT03073733|144260681|SUPERIORITY||least squares mean difference|-278.73|STANDARD_ERROR_OF_MEAN|305.192||0.515|TWO_SIDED|95.0|-1126.21|568.75|||linear model for repeated measures|||||568.75|-1126.21|0.515
72375090|NCT03073733|144260681|SUPERIORITY||least squares mean difference|292.18|STANDARD_ERROR_OF_MEAN|308.659||0.499|TWO_SIDED|95.0|-562.87|1147.23|||linear model for repeated measures|||||1147.23|-562.87|0.499
72555726|NCT01020474|144642745|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.97||||0.008|TWO_SIDED|95.0|-1.69|-0.25|||Mixed Models Analysis|||Statistical analysis of Week 10.||-0.25|-1.69|0.008
72555727|NCT01020474|144642745|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.86||||0.021|TWO_SIDED|95.0|-1.59|-0.13|||Mixed Models Analysis|||Statistical analysis of Week 11.||-0.13|-1.59|0.021
72555728|NCT01020474|144642745|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.97||||0.01|TWO_SIDED|95.0|-1.71|-0.23|||Mixed Models Analysis|||Statistical analysis of Week 12.||-0.23|-1.71|0.010
72375091|NCT03073733|144260682|SUPERIORITY||least squares mean difference|-0.9|STANDARD_ERROR_OF_MEAN|0.42||0.16|TWO_SIDED|95.0|-2.1|0.3|||linear model for repeated measures|||||0.3|-2.1|0.160
72375092|NCT03073733|144260682|SUPERIORITY||least squares mean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.43||0.622|TWO_SIDED|95.0|-1.5|0.9|||linear model for repeated measures|||||0.9|-1.5|0.622
72375093|NCT03073733|144260683|SUPERIORITY||least squares mean difference|-0.111|STANDARD_ERROR_OF_MEAN|0.1038||0.442|TWO_SIDED|95.0|-0.399|0.176|||linear model for repeated measures|||||0.176|-0.399|0.442
72375094|NCT03073733|144260683|SUPERIORITY||least squares mean difference|0.122|STANDARD_ERROR_OF_MEAN|0.1037||0.401|TWO_SIDED|95.0|-0.165|0.409|||linear model for repeated measures|||||0.409|-0.165|0.401
72375095|NCT03073733|144260685|SUPERIORITY|||||||0.205|||||||Fisher Exact|||||||0.205
72375096|NCT03073733|144260686|SUPERIORITY|||||||0.157|||||||Fisher Exact|||||||0.157
72375097|NCT03073733|144260687|SUPERIORITY|||||||0.125|||||||Fisher Exact|||||||0.125
72375098|NCT03073733|144260688|SUPERIORITY|||||||0.173|||||||Fisher Exact|||||||0.173
72375099|NCT03073733|144260689|SUPERIORITY|||||||0.099|||||||t-test, 1 sided|Pooled t-test (variance ratio of 3.2)||||||0.099
72375100|NCT03073733|144260689|SUPERIORITY|||||||0.13|||||||t-test, 1 sided|Pooled t-test (variance ratio of 1.9)||||||0.130
72375101|NCT03073733|144260690|SUPERIORITY|||||||0.0959|||||||Fisher Exact|||||||0.0959
72375102|NCT03073733|144260691|SUPERIORITY|||||||0.1868|||||||Fisher Exact|||||||0.1868
72375103|NCT03073733|144260692|SUPERIORITY|||||||0.608|||||||Fisher Exact|||||||0.608
72375104|NCT03073733|144260693|SUPERIORITY|||||||0.264|||||||t-test, 1 sided|Unpooled t-test (variance ratio of 7.9)||||||0.264
72375105|NCT03073733|144260693|SUPERIORITY|||||||0.139|||||||t-test, 1 sided|Unpooled t-test (variance ratio of 25.9)||||||0.139
72375106|NCT03073733|144260694|SUPERIORITY|||||||0.261|||||||t-test, 1 sided|Unpooled t-test (variance ratio of 7.9)||||||0.261
72433542|NCT04888585|144380260|SUPERIORITY||Response Rate Difference|25.5|||<|0.001|TWO_SIDED|95.0|14.3|36.7|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted for the stratification factors.|Response Rate Difference = ABBV-154 340mg EOW - Placebo|||36.7|14.3|<0.001
72555729|NCT01020474|144642745|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.74||||0.051|TWO_SIDED|95.0|-1.49|0.0|||Mixed Models Analysis|||Statistical analysis of Week 13.||0.00|-1.49|0.051
72555730|NCT01020474|144642745|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.9||||0.02|TWO_SIDED|95.0|-1.66|-0.14|||Mixed Models Analysis|||Statistical analysis of Week 14.||-0.14|-1.66|0.020
72375107|NCT03073733|144260694|SUPERIORITY|||||||0.139|||||||t-test, 1 sided|Unpooled t-test (variance ratio of 6.3)||||||0.139
72375108|NCT03073733|144260695|SUPERIORITY|||||||0.35|||||||t-test, 1 sided|Pooled t-test (variance ratio of 0.8).||||||0.350
72375109|NCT03073733|144260695|SUPERIORITY|||||||0.5|||||||t-test, 1 sided|Pooled t-test (variance ratio of 2.5)||||||0.500
72375110|NCT03073733|144260696|SUPERIORITY|||||||0.22|||||||t-test, 1 sided|Pooled t-test (variance ratio of 2.9).||||||0.220
72375111|NCT03073733|144260696|SUPERIORITY|||||||0.119|||||||t-test, 1 sided|Pooled t-test (variance ratio of 1.9).||||||0.119
72375112|NCT03073733|144260697|SUPERIORITY|||||||0.006|||||||t-test, 1 sided|Pooled t-test (variance ratio of 2.7)||||||0.006
72375113|NCT03073733|144260698|SUPERIORITY|||||||0.009|||||||Fisher Exact|||||||0.009
72375114|NCT03073733|144260699|SUPERIORITY|||||||0.029|||||||Fisher Exact|||||||0.029
72375115|NCT03073733|144260700|SUPERIORITY|||||||0.01|||||||Fisher Exact|||||||0.010
72375116|NCT03073733|144260701|SUPERIORITY|||||||0.072|||||||Fisher Exact|||||||0.072
72375117|NCT03073733|144260702|SUPERIORITY|||||||0.019|||||||t-test, 1 sided|Unpooled t-test (variance ratio of 5.9)||||||0.019
72375118|NCT03073733|144260702|SUPERIORITY|||||||0.019|||||||t-test, 1 sided|Pooled t-test (variance ratio of 3.98)||||||0.019
72375119|NCT03073733|144260703|SUPERIORITY|||||||0.013|||||||Fisher Exact|||||||0.013
72375120|NCT03073733|144260704|SUPERIORITY|||||||0.033|||||||Fisher Exact|||||||0.033
72375121|NCT03073733|144260705|SUPERIORITY|||||||0.199|||||||Fisher Exact|||||||0.199
72375122|NCT03073733|144260706|SUPERIORITY|||||||0.075|||||||t-test, 1 sided|Unpooled t-test (variance ratio of 56.3)||||||0.075
72375123|NCT03073733|144260706|SUPERIORITY|||||||0.062|||||||t-test, 1 sided|Unpooled t-test (variance ratio of 25.2)||||||0.062
72555731|NCT01020474|144642745|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.74||||0.06|TWO_SIDED|95.0|-1.51|0.03|||Mixed Models Analysis|||Statistical analysis of Week 15.||0.03|-1.51|0.060
72375124|NCT03073733|144260707|SUPERIORITY|||||||0.255|||||||t-test, 1 sided|Unpooled t-test (variance ratio of 9.9)||||||0.255
72375125|NCT03073733|144260707|SUPERIORITY|||||||0.109|||||||t-test, 1 sided|Unpooled t-test (variance ratio of 8.7)||||||0.109
72375126|NCT03073733|144260708|SUPERIORITY|||||||0.488|||||||t-test, 1 sided|Pooled t-test (variance ratio of 0.7).||||||0.488
72375127|NCT03073733|144260708|SUPERIORITY|||||||0.273|||||||t-test, 1 sided|Pooled t-test (variance ratio of 2.5)||||||0.273
72375128|NCT03073733|144260709|SUPERIORITY|||||||0.004|||||||Fisher Exact|||||||0.004
72375129|NCT03073733|144260710|SUPERIORITY|||||||0.006|||||||Fisher Exact|||||||0.006
72375130|NCT03073733|144260711|SUPERIORITY|||||||0.016|||||||Fisher Exact|||||||0.016
72555732|NCT01020474|144642746|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.21||||0.54|TWO_SIDED|95.0|-0.9|0.47|||Mixed Models Analysis|||Statistical analysis of Week 1.||0.47|-0.90|0.540
72555733|NCT01020474|144642746|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.19||||0.593|TWO_SIDED|95.0|-0.87|0.5|||Mixed Models Analysis|||Statistical analysis of Week 2||0.50|-0.87|0.593
72375131|NCT03073733|144260712|SUPERIORITY|||||||0.098|||||||Fisher Exact|||||||0.098
72375132|NCT03073733|144260713|SUPERIORITY|||||||0.019|||||||t-test, 1 sided|Unpooled t-test (variance ratio of 8.2)||||||0.019
72375133|NCT03073733|144260713|SUPERIORITY|||||||0.011|||||||t-test, 1 sided|Unpooled t-test (variance ratio of 4.7)||||||0.011
72375134|NCT03073733|144260714|SUPERIORITY|||||||0.039|||||||Fisher Exact|||||||0.039
72375135|NCT03073733|144260715|SUPERIORITY|||||||0.096|||||||Fisher Exact|||||||0.096
72375136|NCT03073733|144260716|SUPERIORITY|||||||0.48|||||||Fisher Exact|||||||0.480
72375137|NCT03073733|144260717|SUPERIORITY|||||||0.076|||||||t-test, 1 sided|Unpooled t-test (variance ratio of 51.5)||||||0.076
72375138|NCT03073733|144260717|SUPERIORITY|||||||0.057|||||||t-test, 1 sided|Unpooled t-test (variance ratio of 26.1)||||||0.057
72375139|NCT03073733|144260718|SUPERIORITY|||||||0.117|||||||t-test, 1 sided|Unpooled t-test (variance ratio of 29.0)||||||0.117
72375140|NCT03073733|144260718|SUPERIORITY|||||||0.083|||||||t-test, 1 sided|Unpooled t-test (variance ratio of 9.5)||||||0.083
72375141|NCT03073733|144260719|SUPERIORITY|||||||0.172|||||||t-test, 1 sided|Unpooled t-test (variance ratio of 6.7)||||||0.172
72375142|NCT03073733|144260719|SUPERIORITY|||||||0.14|||||||t-test, 1 sided|Pooled t-test (variance ratio of 3.98)||||||0.140
72375143|NCT03073733|144260720|SUPERIORITY|||||||0.011|||||||t-test, 1 sided|Unpooled t-test (variance ratio of 5.4).||||||0.011
72375144|NCT03073733|144260721|SUPERIORITY|||||||0.0406|||||||Fisher Exact|||||||0.0406
72375145|NCT03073733|144260722|SUPERIORITY|||||||0.007|||||||Fisher Exact|||||||0.007
72375146|NCT03073733|144260723|SUPERIORITY|||||||0.026|||||||Fisher Exact|||||||0.026
72375147|NCT03073733|144260724|SUPERIORITY|||||||0.2|||||||Fisher Exact|||||||0.200
72375148|NCT03073733|144260725|SUPERIORITY|||||||0.03|||||||t-test, 1 sided|Unpooled t-test (variance ratio of 22.2)||||||0.030
72375149|NCT03073733|144260725|SUPERIORITY|||||||0.033|||||||t-test, 1 sided|Pooled t-test (variance ratio of 3.3)||||||0.033
72375150|NCT03073733|144260726|SUPERIORITY|||||||0.2|||||||Fisher Exact|||||||0.200
72375151|NCT03073733|144260727|SUPERIORITY|||||||0.2|||||||Fisher Exact|||||||0.200
72375152|NCT03073733|144260728|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1
72375153|NCT03073733|144260729|SUPERIORITY|||||||0.08|||||||t-test, 1 sided|Unpooled t-test (variance ratio of 606.4)||||||0.080
72375154|NCT03073733|144260729|SUPERIORITY|||||||0.05|||||||t-test, 1 sided|Unpooled t-test (variance ratio of 52.3)||||||0.050
72375155|NCT03073733|144260730|SUPERIORITY|||||||0.099|||||||t-test, 1 sided|Unpooled t-test (variance ratio of 35.7)||||||0.099
72375156|NCT03073733|144260730|SUPERIORITY|||||||0.076|||||||t-test, 1 sided|Unpooled t-test (variance ratio of 17.6)||||||0.076
72375157|NCT03073733|144260731|SUPERIORITY|||||||0.1099|||||||t-test, 1 sided|Unpooled t-test (variance ratio of 4.5)||||||0.1099
72375158|NCT03073733|144260731|SUPERIORITY|||||||0.012|||||||t-test, 1 sided|Unpooled t-test (variance ratio of 14.3)||||||0.012
72375159|NCT00167778|144260754|SUPERIORITY_OR_OTHER||||||>|0.99||95.0||||Statistical significance was set a-prior at p\<0.05.|Mixed Models Analysis|||||||>0.99
72375160|NCT00167778|144260755|SUPERIORITY_OR_OTHER||||||=|0.09||95.0||||Statistical significance was set a-prior at p\<0.05.|Mixed Models Analysis|||||||=0.09
72375161|NCT00167778|144260756|SUPERIORITY_OR_OTHER||||||=|0.09||95.0||||Statistical significance was set a-prior at p\<0.05.|Mixed Models Analysis|||||||=0.09
72375162|NCT00167778|144260757|SUPERIORITY_OR_OTHER||||||=|0.7||95.0||||Statistical significance was set a-prior at p\<0.05.|Mixed Models Analysis|||||||=0.7
72375163|NCT00167778|144260758|SUPERIORITY_OR_OTHER||||||>|0.99||95.0||||Statistical significance was set a-prior at p\<0.05.|Mixed Models Analysis|||||||>0.99
72375164|NCT00167778|144260760|SUPERIORITY_OR_OTHER||||||=|0.8||95.0||||Statistical significance was set a-prior at p\<0.05.|Mixed Models Analysis|||||||=0.8
72375165|NCT00167778|144260761|SUPERIORITY_OR_OTHER||||||=|0.7||95.0||||Statistical significance was set a-prior at p\<0.05.|Mixed Models Analysis|||||||=0.7
72375166|NCT00167778|144260762|SUPERIORITY_OR_OTHER||||||=|0.4||95.0||||Statistical significance was set a-prior at p\<0.05.|Mixed Models Analysis|||||||=.4
72375167|NCT00167778|144260763|SUPERIORITY_OR_OTHER||||||>|0.15||95.0||||Statistical significance was set a-prior at p\<0.05. Values of p\>0.15 were considered not significant (NS) statistically.|Mixed Models Analysis|The effect of study prosthesis was analyzed using repeated measures one-way analyses of variance.||||||>0.15
72555734|NCT01020474|144642746|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.44||||0.206|TWO_SIDED|95.0|-1.13|0.25|||Mixed Models Analysis|||Statistical analysis of Week 3.||0.25|-1.13|0.206
72555735|NCT01020474|144642746|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.49||||0.168|TWO_SIDED|95.0|-1.18|0.21|||Mixed Models Analysis|||Statistical analysis of Week 4.||0.21|-1.18|0.168
72555736|NCT01020474|144642746|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.38||||0.28|TWO_SIDED|95.0|-1.08|0.32|||Mixed Models Analysis|||Statistical analysis of Week 5.||0.32|-1.08|0.280
72555737|NCT01020474|144642746|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.64||||0.075|TWO_SIDED|95.0|-1.34|0.06|||Mixed Models Analysis|||Statistical analysis of Week 6.||0.06|-1.34|0.075
72555738|NCT01020474|144642746|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.5||||0.168|TWO_SIDED|95.0|-1.21|0.21|||Mixed Models Analysis|||Statistical analysis of Week 7.||0.21|-1.21|0.168
72375168|NCT00167778|144260764|SUPERIORITY_OR_OTHER||||||>|0.15||95.0||||Statistical significance was set a-prior at p\<0.05. Values of p\>0.15 were considered not significant (NS) statistically.|Mixed Models Analysis|The effect of study prosthesis was analyzed using repeated measures one-way analyses of variance.||||||>0.15
72375169|NCT00167778|144260765|SUPERIORITY_OR_OTHER||||||>|0.15||95.0||||Statistical significance was set a-prior at p\<0.05. Values of p\>0.15 were considered not significant (NS) statistically.|Mixed Models Analysis|The effect of study prosthesis was analyzed using repeated measures one-way analyses of variance.||||||>0.15
72375170|NCT00167778|144260766|SUPERIORITY_OR_OTHER||||||>|0.15||95.0||||Statistical significance was set a-prior at p\<0.05. Values of p\>0.15 were considered not significant (NS) statistically.|Mixed Models Analysis|The effect of study prosthesis was analyzed using repeated measures one-way analyses of variance.||||||>0.15
72375171|NCT00167778|144260767|SUPERIORITY_OR_OTHER||||||>|0.15||95.0||||Statistical significance was set a-prior at p\<0.05. Values of p\>0.15 were considered not significant (NS) statistically.|Mixed Models Analysis|The effect of study prosthesis was analyzed using repeated measures one-way analyses of variance.||||||>0.15
72375172|NCT00167778|144260768|SUPERIORITY_OR_OTHER||||||>|0.15||95.0||||Statistical significance was set a-prior at p\<0.05. Values of p\>0.15 were considered not significant (NS) statistically.|Mixed Models Analysis|The effect of study prosthesis was analyzed using repeated measures one-way analyses of variance.||||||>0.15
72375173|NCT00167778|144260769|SUPERIORITY_OR_OTHER||||||=|0.13||95.0||||Statistical significance was set a-prior at p\<0.05.|Wilcoxon (Mann-Whitney)|Wilcoon paired signed rank test for the differences between Rigid and Torsion Adapter pylons||||||=0.13
72375174|NCT00167778|144260770|SUPERIORITY_OR_OTHER||||||=|0.92||95.0||||Statistical significance was set a-prior at p\<0.05.|Wilcoxon (Mann-Whitney)|Wilcoxon paired signed rank test for the differences between Rigid and Torsion Adapter pylons.||||||=0.92
72375175|NCT00167778|144260771|SUPERIORITY_OR_OTHER||||||=|0.37||95.0||||Statistical significance was set a-prior at p\<0.1.|Wilcoxon (Mann-Whitney)|Wilcoxon paired signed rank test for the differences between the Rigid and Torsion Adapter pylons.||||||=0.37
72375176|NCT00167778|144260772|SUPERIORITY_OR_OTHER||||||=|0.27||95.0||||Statistical significance was set a-prior at p\<0.1.|Wilcoxon (Mann-Whitney)|Wilcoxon paired signed rank test for the differences between the Rigid and Torsion Adapter pylons.||||||=0.27
72375177|NCT00167778|144260773|SUPERIORITY_OR_OTHER||||||=|0.2||95.0||||Statistical significance was set a-prior at p\<0.1.|Wilcoxon (Mann-Whitney)|Wilcoxon paired signed rank test for the differences between the Rigid and Torsion Adapter pylons.||||||=0.20
72375178|NCT00167778|144260774|SUPERIORITY_OR_OTHER||||||=|0.59||95.0||||Statistical significance was set a-prior at p\<0.1.|Wilcoxon (Mann-Whitney)|Wilcoxon paired signed rank test for the differences between the Rigid and Torsion Adapter pylons.||||||=0.59
72375179|NCT00167778|144260775|SUPERIORITY_OR_OTHER||||||=|0.057||95.0||||Statistical significance was set a-prior at p\<0.1.|Wilcoxon (Mann-Whitney)|Wilcoxon paired signed rank test for the differences between the Rigid and Torsion Adapter pylons.||||||=0.057
72375180|NCT00167778|144260776|SUPERIORITY_OR_OTHER||||||=|0.78||95.0||||Statistical significance was set a-prior at p\<0.1.|Wilcoxon (Mann-Whitney)|Wilcoxon paired signed rank test for the differences between the Rigid and Torsion Adapter pylons.||||||=0.78
72375181|NCT00576420|144260787|SUPERIORITY_OR_OTHER|||||||0.1564||90.0|||||Likelihood ratio chi-square test|||||||0.1564
72375182|NCT00576420|144260789|SUPERIORITY_OR_OTHER|||||||0.06||95.0|||||Likelihood ratio chi-square test|||||||0.060
72375183|NCT00576420|144260789|SUPERIORITY_OR_OTHER|||||||0.005||95.0|||||Likelihood ratio chi-square test|||||||0.005
72375184|NCT00576420|144260790|SUPERIORITY_OR_OTHER|||||||0.123||95.0|||||Likelihood ratio chi-square test|||||||0.123
72375185|NCT00576420|144260790|SUPERIORITY_OR_OTHER|||||||0.026||95.0|||||Likelihood ratio chi-square test|||||||0.026
72375186|NCT00576420|144260791|SUPERIORITY_OR_OTHER|||||||0.929||95.0|||||Likelihood ratio chi-square test|||||||0.929
72375187|NCT00576420|144260791|SUPERIORITY_OR_OTHER|||||||0.228||95.0|||||Likelihood ratio chi-square test|||||||0.228
72375188|NCT00576420|144260793|SUPERIORITY_OR_OTHER|||||||0.234||95.0|||||Likelihood ratio chi-square test|||||||0.234
72375189|NCT00576420|144260793|SUPERIORITY_OR_OTHER|||||||0.955||95.0|||||Likelihood ratio chi-square test|||||||0.955
72375190|NCT00576420|144260794|SUPERIORITY_OR_OTHER|||||||0.106||95.0|||||Likelihood ratio chi-square test|||||||0.106
72375191|NCT00576420|144260794|SUPERIORITY_OR_OTHER|||||||0.243||95.0|||||Likelihood ratio chi-square test|||||||0.243
72375192|NCT00576420|144260794|SUPERIORITY_OR_OTHER|||||||0.127||95.0|||||Likelihood ratio chi-square test|||||||0.127
72375193|NCT00576420|144260795|SUPERIORITY_OR_OTHER|||||||0.257||95.0|||||Likelihood ratio chi-square test|||||||0.257
72375194|NCT00576420|144260795|SUPERIORITY_OR_OTHER|||||||0.096||95.0|||||Likelihood ratio chi-square test|||||||0.096
72375195|NCT00576420|144260795|SUPERIORITY_OR_OTHER|||||||0.127||95.0|||||Likelihood ratio chi-square test|||||||0.127
72375196|NCT01340872|144260818|SUPERIORITY||Mean Difference (Final Values)|2.18|STANDARD_ERROR_OF_MEAN|0.19|<|0.0001|ONE_SIDED|97.5|1.81||||ANCOVA|||ANCOVA for primary endpoint, Change in Hb concentration from Baseline to Week 12 in double-blind phase, FAS|||1.81|< 0.0001
72375197|NCT01340872|144260822|SUPERIORITY||Mean Difference (Final Values)|1.04|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001|ONE_SIDED|97.5|0.82||||ANCOVA|||ANCOVA analysis of the change in Hb concentration from Baseline to Week 4 of the double-blind phase - Full Analysis Set, multiple imputation|||0.82|< 0.0001
72375198|NCT01340872|144260823|SUPERIORITY||Mean Difference (Final Values)|1.73|STANDARD_ERROR_OF_MEAN|0.15|<|0.0001|ONE_SIDED|97.5|1.43||||ANCOVA|||ANCOVA analysis of Change in Hb concentration from Baseline to Week 8 of double-blind phase - FAS, multiple imputation|||1.43|< 0.0001
72375199|NCT01340872|144260834|SUPERIORITY||Mean Difference (Final Values)|2.18|STANDARD_ERROR_OF_MEAN|0.17|<|0.0001|ONE_SIDED|97.5|1.87||||ANCOVA|||ANCOVA sensitivity analysis of the Primary efficacy endpoint analysis on the PPAS|||1.87|< 0.0001
72433543|NCT04888585|144380260|SUPERIORITY||Response Rate Difference|14.1||||0.007|TWO_SIDED|95.0|3.8|24.5|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted for the stratification factors.|Response Rate Difference = ABBV-154 340mg E4W - Placebo|||24.5|3.8|0.007
72375200|NCT01340872|144260835|SUPERIORITY||Mean Difference (Final Values)|2.15|STANDARD_ERROR_OF_MEAN|0.16|<|0.0001|ONE_SIDED|97.5|1.82||||ANCOVA|||ANCOVA sensitivity analysis of the Primary efficacy endpoint analysis on the FAS LOCF - Change in Haemoglobin Concentration from Baseline to Week 12|||1.82|< 0.0001
72375201|NCT01502332|144260844|SUPERIORITY_OR_OTHER|||||||0.016|||||||Wilcoxon (Mann-Whitney)|||||||0.016
72555739|NCT01020474|144642746|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.01||||0.006|TWO_SIDED|95.0|-1.73|-0.3|||Mixed Models Analysis|||Statistical analysis of Week 8.||-0.30|-1.73|0.006
72555740|NCT01020474|144642746|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-0.57||||0.12|TWO_SIDED|95.0|-1.29|0.15|||Mixed Models Analysis|||Statistical analysis of Week 9.||0.15|-1.29|0.120
72555741|NCT01020474|144642746|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.77||||0.037|TWO_SIDED|95.0|-1.49|-0.05|||Mixed Models Analysis|||Statistical analysis of Week 10.||-0.05|-1.49|0.037
72555742|NCT01020474|144642746|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.43||||0.246|TWO_SIDED|95.0|-1.16|0.3|||Mixed Models Analysis|||Statistical analysis of Week 11.||0.30|-1.16|0.246
72555743|NCT01020474|144642746|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.61||||0.105|TWO_SIDED|95.0|-1.36|0.13|||Mixed Models Analysis|||Statistical analysis of Week 12.||0.13|-1.36|0.105
72555744|NCT01020474|144642746|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.34||||0.376|TWO_SIDED|95.0|-1.09|0.41|||Mixed Models Analysis|||Statistical analysis of Week 13.||0.41|-1.09|0.376
72555745|NCT01020474|144642746|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.41||||0.285|TWO_SIDED|95.0|-1.18|0.35|||Mixed Models Analysis|||Statistical analysis of Week 14.||0.35|-1.18|0.285
72555746|NCT01020474|144642746|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.17||||0.663|TWO_SIDED|95.0|-0.95|0.61|||Mixed Models Analysis|||Statistical analysis of Week 15.||0.61|-0.95|0.663
72555747|NCT01020474|144642747|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.87||||0.037|TWO_SIDED|95.0|-1.68|-0.05|||ANCOVA|Based on LS Means using analysis of covariance (ANCOVA) model (including Treatment, Center, Baseline value as covariate).||||-0.05|-1.68|0.037
72555748|NCT01020474|144642748|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.17||||0.694|TWO_SIDED|95.0|0.53|2.58|||Regression, Logistic|||Statistical analysis at Week 15.||2.58|0.53|0.694
72375202|NCT01502332|144260845|SUPERIORITY_OR_OTHER|||||||0.014|||||||Log Rank|||||||0.014
72375203|NCT01502332|144260846|SUPERIORITY_OR_OTHER|||||||0.037|||||||Log Rank|||||||0.037
72375204|NCT01502332|144260848|SUPERIORITY_OR_OTHER|||||||0.267|||||||Regression, Logistic|||||||0.267
72555749|NCT01020474|144642749|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.25||||0.162|TWO_SIDED|95.0|0.72|7.02|||Regression, Logistic|||Statistical analysis at Week 15.||7.02|0.72|0.162
72555750|NCT01020474|144642750|SUPERIORITY_OR_OTHER_LEGACY|||||||0.013|||||||Cochran-Mantel-Haenszel|P-value uses the row mean score statistic based on Cochran Mantel Haenszel (CMH) test with modified ridit transformation.||Statistical analysis at Week 15.||||0.013
72555751|NCT00835146|144642751|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|97.9||||||90.0|91.8|105.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||105|91.8|
72555752|NCT00835146|144642752|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|99.3||||||90.0|93.3|106.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||106|93.3|
72555753|NCT00466167|144642760|SUPERIORITY_OR_OTHER||Adjusted mean difference from placebo|4.9|STANDARD_ERROR_OF_MEAN|1.3||0.0001|TWO_SIDED|95.0|2.4|7.4|||ANCOVA|||ANCOVA with factors treatment, pooled country and covariate baseline||7.4|2.4|0.0001
72555754|NCT00466167|144642760|SUPERIORITY_OR_OTHER||Adjusted mean difference from placebo|6.6|STANDARD_ERROR_OF_MEAN|1.2|<|0.0001|TWO_SIDED|95.0|4.2|9.1|||ANCOVA|||ANCOVA with factors treatment, pooled country and covariate baseline||9.1|4.2|<.0001
72555755|NCT00466167|144642761|SUPERIORITY_OR_OTHER||Adjusted mean difference from Placebo|4.5|STANDARD_ERROR_OF_MEAN|1.8||0.0122|TWO_SIDED|95.0|1.0|7.9|||ANCOVA|||ANCOVA with factors treatment, pooled country and covariate baseline||7.9|1.0|0.0122
72555756|NCT00466167|144642761|SUPERIORITY_OR_OTHER||Adjusted mean difference from placebo|7.1|STANDARD_ERROR_OF_MEAN|1.7|<|0.0001|TWO_SIDED|95.0|3.7|10.5|||ANCOVA|||ANCOVA with factors treatment, pooled country and covariate baseline||10.5|3.7|<.0001
72555757|NCT02927639|144642782|SUPERIORITY|"A subject was considered completed if they completed all 3 SCI (as indicated in participant flow section) - 13 control, 10 intervention.~However, the mixed model took in to account ALL available data. As such, there were 70 control, 65 intervention that completed at least 1 SCI. Their data was analyzed by the model and used to predict later outcomes so they were considered to be included in the analysis."||||||0.035||||||The mixed model may provide a significantly different change in SCI score from baseline to the 6 month using a per-protocol analysis in the intervention group as compared to the control group. A p value \<0.05 was considered significant.|Mixed Models Analysis|||A multilevel mixed effects linear regression model was used to analyze this data. This analysis allowed for an estimation of missing data. This explains the discrepancy in the number of participant study completion vs participant data analyzed (see below).||||0.035
72555758|NCT02825680|144642786|SUPERIORITY|||||||0.011|||||||Mixed Models Analysis|||This analysis compares reach within the pre-intervention timeframe versus the post-intervention timeframe for each LEAP (intervention) and control case. Intention to treat analysis was used; all participating facilities randomized to the LEAP (intervention) arm were included whether or not they completed the intervention.||||.011
72555759|NCT04633564|144642804|EQUIVALENCE|The equivalence region is (0.73, 1.36).|Risk Ratio (RR)|0.96|||||TWO_SIDED|90.0|0.83|1.12||||||||1.12|0.83|
72555760|NCT02433977|144642805|OTHER||||||<=|0.05|||||||t-test, 1 sided|||||||<=0.05
72555761|NCT02433977|144642806|OTHER||||||<=|0.05|||||||t-test, 1 sided|||||||<=0.05
72555762|NCT02433977|144642807|OTHER||||||<=|0.05|||||||t-test, 1 sided|||||||<=0.05
72555763|NCT02433977|144642808|OTHER||||||<=|0.05|||||||t-test, 1 sided|||||||<=0.05
72555764|NCT02433977|144642810|OTHER||||||<=|0.05|||||||t-test, 1 sided|||||||<=0.05
72555765|NCT02433977|144642812|OTHER||||||<=|0.05|||||||t-test, 1 sided|||||||<=0.05
72555766|NCT02433977|144642813|OTHER||||||<=|0.05|||||||t-test, 1 sided|||||||<=0.05
72555767|NCT02433977|144642814|OTHER||||||<=|0.05|||||||t-test, 1 sided|||||||<=0.05
72375205|NCT03603509|144260865|SUPERIORITY|||||||0.062|||||||Wilcoxon (Mann-Whitney)|||Null Hypothesis: HAI Day 28 - HAI Day 0 for Fluad = HAI Day 28 - HAI Day 0 for Fluzone Alternative Hypothesis: HAI Day 28 - HAI Day 0 for Fluad NE HAI Day 28 - HAI Day 0 for Fluzone||||0.062
72375206|NCT03603509|144260874|SUPERIORITY|null hypothesis: CMV Fluad sample index = CMV Fluzone sample index at Baseline alternate hypothesis: CMV Fluad sample index not equal to CMV Fluzone sample index at Baseline||||||0.29|||||||Wilcoxon (Mann-Whitney)|||||||0.29
72375207|NCT02656680|144260879|SUPERIORITY|||||||0.72|||||||Wilcoxon (Mann-Whitney)|||Mann-Whitney U Test||||0.72
72375208|NCT02656680|144260880|SUPERIORITY|||||||0.31|||||||Chi-squared|||Chi square test comparing proportion retained in each condition.||||0.31
72375209|NCT02656680|144260881|SUPERIORITY|||||||0.69|||||||Chi-squared|||||||0.69
72375210|NCT02656680|144260882|SUPERIORITY|||||||0.218|||||||ANOVA|||We compared mean percent weight loss from baseline across groups with a one-way ANOVA. One participant became pregnant and thus removed from the analysis. This analysis is exploratory given that this pilot study was not powered to detect weight loss differences between groups.||||0.218
72375211|NCT02656680|144260883|SUPERIORITY|||||||0.421|||||||ANOVA|||||||0.421
72375212|NCT04966910|144260884|SUPERIORITY|||||||0.036||||||This p-value applies to the time x condition interaction variable in a repeated-measure ANOVA for client data.|ANOVA|||Repeated measures ANOVA including a time x condition interaction term to test for differences in slopes by condition for client data.||||0.036
72375213|NCT04966910|144260885|SUPERIORITY|||||||0.226||||||This p-value refers to a time x condition interaction term in a repeated measures ANOVA.|ANOVA|||||||.226
72375214|NCT04966910|144260886|SUPERIORITY|||||||0.674||||||This p-value refers to a time x condition interaction term in a repeated measures ANOVA to test for differences in slopes over time.|ANOVA|||||||.674
72375215|NCT04966910|144260887|SUPERIORITY|||||||0.317||||||This p-value refers to a time x condition interaction term in a repeated measures ANOVA to test for differences in slopes over time.|ANOVA|||||||.317
72375216|NCT04966910|144260888|SUPERIORITY|||||||0.741||||||This p-value refers to a time x condition interaction term in a repeated measures ANOVA to test for differences in slopes over time.|ANOVA|||||||.741
72375217|NCT04966910|144260889|SUPERIORITY|||||||0.737||||||This p-value refers to a time x condition interaction term in a repeated measures ANOVA to test for differences in slopes over time.|ANOVA|||||||.737
72375218|NCT00789074|144260901|SUPERIORITY_OR_OTHER|||||||0.14||95.0|||||ANOVA|||||||0.14
72375219|NCT00789074|144260902|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA|Changes were compared using repeated measures analysis of variance||||||<0.001
72375220|NCT00789074|144260903|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||F=16.60|ANOVA|Changes were compared using repeated measures analysis of variance||||||<0.001
72375221|NCT00789074|144260904|SUPERIORITY_OR_OTHER||||||<|0.04||95.0||||F=2.92|ANOVA|Changes were compared using repeated measures analysis of variance||||||<0.04
72375222|NCT00789074|144260905|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||ANOVA|Changes were compared using repeated measures analysis of variance||||||0.02
72375223|NCT00789074|144260906|SUPERIORITY_OR_OTHER|||||||0.97||95.0|||||ANOVA|Changes were compared using repeated measures analysis of variance||||||0.97
72375224|NCT01733212|144260920|EQUIVALENCE|Considering the null hypothesis that the number of participants who will have vomiting will be equal in the two arms, we performed this study with a significance level of 0.05% and power of 80% to prove that there is a difference in the number.||||||0.07|||||||Chi-squared|||Number of participants who had vomiting in each group is compared to the other. Two sided Chi square test was conducted, Type I error of 0.05% and power of 80% are considered.||||0.07
72375225|NCT00775203|144260921|SUPERIORITY_OR_OTHER|||||||0.0119|||||||ANCOVA|ANCOVA with treatment and study center as categorical factors and HAMD-17 baseline as covariate.||The primary null hypothesis for the HAMD-17 total score is that there is no difference between the Trazodone Contramid® OAD group and the placebo group at Week 8. A sample size of 133 in each group will have 90% power to detect a difference in the absolute mean Hamilton Rating Scale for Depression (HAMD-17) change from baseline of 3.0 units assuming that the common standard deviation is 7.5 using a two-group t-test with a 0.05 two-sided significance level.||||0.0119
72375226|NCT01105065|144260935|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Chi-squared, Corrected|||There would be no change in retinal vascular dysregulation after treatment with brimonidine||||<0.0001
72375227|NCT01105065|144260936|SUPERIORITY_OR_OTHER|||||||0.28|||||||paired t-test|||A paired t-test was used to determine if their was a statistically significant difference between the mean deviation of the frequency doubling perimetry in the RVD patients pre and post brimonidine treatment.||||0.28
72375228|NCT02984943|144260937|OTHER|||||||0.1|||||||Skillings-Mack test|||||||0.10
72375229|NCT02984943|144260938|OTHER|||||||0.1|||||||Skillings-Mack test|||||||0.10
72375230|NCT02984943|144260939|OTHER|||||||0.02|||||||Skillings-Mack test|||||||0.02
72375231|NCT02984943|144260940|OTHER|||||||0.02|||||||Skillings-Mack test|||||||0.02
72375232|NCT02984943|144260941|OTHER|||||||0.004|||||||Skillings-Mack test|||||||0.004
72375233|NCT02984943|144260942|OTHER|||||||0.004|||||||Skillings-Mack test|||||||0.004
72375234|NCT02984943|144260943|OTHER|||||||0.2938|||||||Skillings-Mack test|||||||0.2938
72375235|NCT02984943|144260944|OTHER|||||||0.2938|||||||Skillings-Mack test|||||||0.2938
72375236|NCT02984943|144260945|OTHER|||||||0.0608|||||||Skillings-Mack test|||||||0.0608
72375237|NCT02984943|144260946|OTHER|||||||0.0608|||||||Skillings-Mack test|||||||0.0608
72375238|NCT02984943|144260947|OTHER|||||||0.1496|||||||Skillings-Mack test|||||||0.1496
72375239|NCT02984943|144260948|OTHER|||||||0.1496|||||||Skillings-Mack test|||||||0.1496
72375240|NCT02984943|144260949|OTHER|||||||0.36|||||||Skillings-Mack test|||||||0.36
72375241|NCT02984943|144260950|OTHER|||||||0.36|||||||Skillings-Mack test|||||||0.36
72375242|NCT02984943|144260951|OTHER|||||||0.0012|||||||Skillings-Mack test|||||||0.0012
72375243|NCT02984943|144260952|OTHER|||||||0.0012|||||||Skillings-Mack test|||||||0.0012
72375244|NCT02984943|144260953|OTHER|||||||0.9|||||||Skillings-Mack test|||||||0.90
72375245|NCT02984943|144260954|OTHER|||||||0.9|||||||Skillings-Mack test|||||||0.90
72375246|NCT02984943|144260955|OTHER|||||||0.0068|||||||Skillings-Mack test|||||||0.0068
72375247|NCT02984943|144260956|OTHER|||||||0.0068|||||||Skillings-Mack test|||||||0.0068
72375248|NCT02984943|144260957|OTHER|||||||0.0183|||||||Skillings-Mack test|||||||0.0183
72375249|NCT02984943|144260958|OTHER|||||||0.0183|||||||Skillings-Mack test|||||||0.0183
72375250|NCT02984943|144260959|OTHER|||||||0.08|||||||Skillings-Mack test|||||||0.08
72375251|NCT02984943|144260960|OTHER|||||||0.08|||||||Skillings-Mack test|||||||0.08
72375252|NCT02984943|144260961|OTHER||||||||||||||||||Descriptive statistics only were used|||
72375253|NCT02984943|144260962|OTHER||||||||||||||||||Descriptive statistics only were used|||
72375254|NCT02984943|144260963|OTHER||||||||||||||||||Descriptive statistics only were used|||
72375255|NCT02984943|144260964|OTHER||||||||||||||||||Descriptive statistics only were used|||
72555768|NCT02571907|144642816|OTHER||||||||||||||||||A Bayesian beta-binomial model with a Uniform(0, 1) prior was used to compute a 95% credible interval for the proportion of patients meeting the primary endpoint. The lower bound of this credible interval (2.5th percentile of the posterior distribution) was 91.2%, which was greater than the performance goal of 55%.|||
72555769|NCT02571907|144642817|OTHER||||||||||||||||||A Bayesian beta-binomial model with a Uniform(0, 1) prior was used to compute a 95% credible interval for the proportion of patients meeting the secondary endpoint. The lower bound of this credible interval (2.5th percentile of the posterior distribution) was 70.8%, which was greater than the performance goal of 46%.|||
72375256|NCT02984943|144260965|OTHER||||||||||||||||||Descriptive statistics only were used|||
72375257|NCT02984943|144260966|OTHER||||||||||||||||||Descriptive statistics only were used|||
72555770|NCT03666026|144642818|SUPERIORITY||Risk Ratio (RR)|1.02|||||TWO_SIDED|95.0|1.0|1.03||||||||1.03|1.00|
72555771|NCT03666026|144642818|SUPERIORITY||Risk Ratio (RR)|1.02|||||TWO_SIDED|95.0|1.0|1.04||||||||1.04|1.00|
72555772|NCT03666026|144642818|SUPERIORITY||Risk Ratio (RR)|1.02|||||TWO_SIDED|95.0|1.0|1.04||||||||1.04|1.00|
72375258|NCT02984943|144260967|OTHER||||||||||||||||||Descriptive statistics only were used|||
72375259|NCT02984943|144260969|OTHER||||||||||||||||||Descriptive statistics only were used|||
72375260|NCT02984943|144260970|OTHER||||||||||||||||||Descriptive statistics only were used|||
72375261|NCT02984943|144260971|OTHER||||||||||||||||||Descriptive statistics only were used|||
72375262|NCT02984943|144260973|OTHER||||||||||||||||||Descriptive statistics only were used|||
72375263|NCT02984943|144260974|OTHER||||||||||||||||||Descriptive statistics only were used|||
72375264|NCT02984943|144260975|OTHER||||||||||||||||||Descriptive statistics only were used|||
72375265|NCT02984943|144260976|OTHER||||||||||||||||||Descriptive statistics only were used|||
72375266|NCT04575597|144260988|OTHER|Difference in rates % and associated confidence intervals (CIs) were based on the Miettinen \& Nurminen method stratified by randomization strata. Unknown survival status at Day 29 was treated as failure.|Difference in Rates %|-4.1|||||TWO_SIDED|95.0|-12.2|2.5||||||||2.5|-12.2|
72375267|NCT04575597|144260988|OTHER|Difference in rates % and associated CIs were based on the Miettinen \& Nurminen method stratified by randomization strata. Unknown survival status at Day 29 was treated as failure.|Difference in Rates %|-1.5|||||TWO_SIDED|95.0|-9.9|6.2||||||||6.2|-9.9|
72375268|NCT04575597|144260988|OTHER|Difference in rates % and associated CIs were based on the Miettinen \& Nurminen method stratified by randomization strata. Unknown survival status at Day 29 was treated as failure.|Differences in Rates %|-1.3|||||TWO_SIDED|95.0|-9.6|6.4||||||||6.4|-9.6|
72375269|NCT04575597|144260988|SUPERIORITY|Difference in rates %, associated CIs, and p-value were based on the Miettinen \& Nurminen method stratified by randomization strata. Unknown survival status at Day 29 was treated as failure.|Difference in Rates %|-6.8||||0.0012|TWO_SIDED|95.0|-11.3|-2.4|||Miettinen & Nurminen|||||-2.4|-11.3|0.0012
72375270|NCT04575597|144260991|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.74|||||TWO_SIDED|95.0|0.48|1.13||||||||1.13|0.48|
72375271|NCT04575597|144260991|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.7|||||TWO_SIDED|95.0|0.46|1.08||||||||1.08|0.46|
72375272|NCT04575597|144260991|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.72|||||TWO_SIDED|95.0|0.47|1.11||||||||1.11|0.47|
72375273|NCT04575597|144260991|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|1.04|||||TWO_SIDED|95.0|0.92|1.18||||||||1.18|0.92|
72375274|NCT04575597|144260992|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|1.49|||||TWO_SIDED|95.0|0.8|2.76||||||||2.76|0.80|
72375275|NCT04575597|144260992|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|1.2|||||TWO_SIDED|95.0|0.69|2.09||||||||2.09|0.69|
72375276|NCT04575597|144260992|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.93|||||TWO_SIDED|95.0|0.54|1.62||||||||1.62|0.54|
72555773|NCT01343004|144642825|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Fisher Exact|||||||<0.0001
72555774|NCT01343004|144642825|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Fisher Exact|||||||<0.0001
72555775|NCT01343004|144642826|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|P-values were derived from contrast tests based on the ANCOVA model fitted using only the data of the two treatment groups to be compared.||||||<0.0001
72555776|NCT01343004|144642826|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|P-values were derived from contrast tests based on the ANCOVA model fitted using only the data of the two treatment groups to be compared.||||||<0.0001
72555777|NCT01343004|144642826|SUPERIORITY_OR_OTHER|||||||0.8155|||||||ANCOVA|P-values were derived from contrast tests based on the ANCOVA model fitted using only the data of the two treatment groups to be compared.||||||0.8155
72555778|NCT01343004|144642827|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|P-values were derived from contrast tests based on the ANCOVA model fitted using only the data of the two treatment groups to be compared.||||||<0.0001
72555779|NCT01343004|144642827|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|P-values were derived from contrast tests based on the ANCOVA model fitted using only the data of the two treatment groups to be compared.||||||<0.0001
72555780|NCT01343004|144642827|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|P-values were derived from contrast tests based on the ANCOVA model fitted using only the data of the two treatment groups to be compared.||||||<0.0001
72375277|NCT04575597|144260992|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|1.12|||||TWO_SIDED|95.0|0.95|1.33||||||||1.33|0.95|
72375278|NCT04575597|144260993|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.95|||||TWO_SIDED|95.0|0.62|1.46||||||||1.46|0.62|
72375279|NCT04575597|144260993|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|1.16|||||TWO_SIDED|95.0|0.75|1.79||||||||1.79|0.75|
72375280|NCT04575597|144260993|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.69|||||TWO_SIDED|95.0|0.45|1.07||||||||1.07|0.45|
72375281|NCT04575597|144260993|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|1.07|||||TWO_SIDED|95.0|0.93|1.23||||||||1.23|0.93|
72375282|NCT04575597|144260994|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|1.06|||||TWO_SIDED|95.0|0.62|1.83||||||||1.83|0.62|
72375283|NCT04575597|144260994|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.71|||||TWO_SIDED|95.0|0.4|1.26||||||||1.26|0.40|
72375284|NCT04575597|144260994|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.41|||||TWO_SIDED|95.0|0.2|0.85||||||||0.85|0.20|
72375285|NCT04575597|144260994|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|1.01|||||TWO_SIDED|95.0|0.86|1.18||||||||1.18|0.86|
72375286|NCT04575597|144260995|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.66|||||TWO_SIDED|95.0|0.32|1.34||||||||1.34|0.32|
72375287|NCT04575597|144260995|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|1.44|||||TWO_SIDED|95.0|0.76|2.71||||||||2.71|0.76|
72375288|NCT04575597|144260995|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.75|||||TWO_SIDED|95.0|0.39|1.42||||||||1.42|0.39|
72555781|NCT01343004|144642828|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|P-values were derived from contrast tests based on the ANCOVA model fitted using only the data of the two treatment groups to be compared.||||||<0.0001
72375289|NCT04575597|144260995|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|1.14|||||TWO_SIDED|95.0|0.94|1.37||||||||1.37|0.94|
72555782|NCT01343004|144642828|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|P-values were derived from contrast tests based on the ANCOVA model fitted using only the data of the two treatment groups to be compared.||||||<0.0001
72375290|NCT04575597|144260996|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|1.03|||||TWO_SIDED|95.0|0.66|1.61||||||||1.61|0.66|
72375291|NCT04575597|144260996|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|1.32|||||TWO_SIDED|95.0|0.83|2.09||||||||2.09|0.83|
72375292|NCT04575597|144260996|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.76|||||TWO_SIDED|95.0|0.47|1.23||||||||1.23|0.47|
72375293|NCT04575597|144260996|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|1.01|||||TWO_SIDED|95.0|0.88|1.16||||||||1.16|0.88|
72375294|NCT04575597|144260997|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.93|||||TWO_SIDED|95.0|0.62|1.41||||||||1.41|0.62|
72375295|NCT04575597|144260997|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|1.09|||||TWO_SIDED|95.0|0.7|1.69||||||||1.69|0.70|
72375296|NCT04575597|144260997|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|1.0|||||TWO_SIDED|95.0|0.66|1.51||||||||1.51|0.66|
72375297|NCT04575597|144260997|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|1.15|||||TWO_SIDED|95.0|1.01|1.31||||||||1.31|1.01|
72375298|NCT04575597|144260998|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.96|||||TWO_SIDED|95.0|0.54|1.69||||||||1.69|0.54|
72433544|NCT04888585|144380261|SUPERIORITY||Response Rate Difference|7.1||||0.017|TWO_SIDED|95.0|1.3|13.0|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted for the stratification factors.|Response Rate Difference = ABBV-154 40mg EOW - Placebo|||13.0|1.3|0.017
72555783|NCT01343004|144642828|SUPERIORITY_OR_OTHER|||||||0.0004|||||||ANCOVA|P-values were derived from contrast tests based on the ANCOVA model fitted using only the data of the two treatment groups to be compared.||||||0.0004
72555784|NCT01343004|144642829|SUPERIORITY_OR_OTHER|||||||0.0318|||||||Chi-squared|||||||0.0318
72555785|NCT01343004|144642829|SUPERIORITY_OR_OTHER|||||||0.2304|||||||Chi-squared|||||||0.2304
72555786|NCT01343004|144642829|SUPERIORITY_OR_OTHER|||||||0.3361|||||||Chi-squared|||||||0.3361
72555787|NCT00526188|144642832|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.46||||||95.0|6.0|12.93|||Test performed based on the 95% CI||Comparison was post-contrast MRI minus pre-contrast MRI|Difference in sensitivity of lesion detection between post- and pre-contrast MRI image set was calculated. Null hypothesis: No difference between post- and pre-contrast MRI image set. Test was performed based on a normal-approximated confidence interval (CI) for the average blinded reader difference. This CI had a confidence level of 95% and was two-sided. The study was planned with a power of 80%.||12.93|6.00|
72555788|NCT00526188|144642833|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.81||||||95.0|1.84|7.78|||Test performed based on the 95% CI||Comparison was post-contrast MRI minus pre-contrast MRI (for investigator's result)|Difference in sensitivity of lesion detection between post- and pre-contrast MRI image sets, based on investigators assessments was calculated. Null hypothesis: No difference between post and pre contrast MRI image set. Test was performed based on a normal-approximated confidence interval (CI) for the investigators difference. This CI had a confidence level of 95% and was two-sided.||7.78|1.84|
72555789|NCT00526188|144642834|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.36||||||95.0|7.45|15.28|||Test performed based on the 95% CI||Comparison was combined pre- and post-contrast MRI minus pre-contrast MRI|Difference in precision of lesion characterization between combined pre and post contrast MRI and pre contrast MRI image set was calculated. Null hypothesis: No difference between combined pre- and post-contrast MRI and pre contrast MRI image set. Test was performed based on a normal-approximated confidence interval (CI) for the average blinded reader difference. This CI had a confidence level of 95% and was two-sided.||15.28|7.45|
72555790|NCT00834717|144642849|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Geometric Test/Ref Ratio x 100|97.86||||||90.0|92.36|103.69|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||103.69|92.36|
72555791|NCT00834717|144642850|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Geometric Test/Ref Ratio x 100|92.57||||||90.0|82.8|103.48|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||103.48|82.80|
72555792|NCT00834717|144642851|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Geometric Test/Ref Ratio x 100|92.95||||||90.0|83.11|103.97|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||103.97|83.11|
72555793|NCT00238615|144642918|SUPERIORITY_OR_OTHER||probability of survival at 2 years|0.72|STANDARD_DEVIATION|0.0|||TWO_SIDED|95.0|0.36|0.9||The primary endpoint of 2 year overall survival was (0.72) = 72%||||2-year overall survival (OS) Our null hypothesis was a probability of survival at 2 years of 0.30. The study was powered at 80% (with α 5% two-tailed) to detect a probability of survival at 2 years of 0.55. This would require 30 patients assuming accrual over 2 years with 1 year of additional follow-up. The probability of survival at 2 years of 0.55 is based on previous studies of neoadjuvant approaches with reported 2 year survival in the 40-60% range.||0.90|0.36|
72555794|NCT05710718|144642919|SUPERIORITY|||||||0.076|||||||paired T-test|No formal hypothesis test was planned for this pilot study. P-values are provided for exploratory purposes and are unadjusted for multiplicity.||||||0.076
72555795|NCT00446966|144642928|SUPERIORITY||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||||||<0.01
72555796|NCT00859521|144642937|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Ratio of Geometric Means|96.7||||||90.0|92.4|101.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||101|92.4|
72555797|NCT00859521|144642938|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Ratio of Geometric Means|98.4||||||90.0|96.9|100.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||100|96.9|
72555798|NCT00859521|144642939|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Ratio of Geometric Means|98.8||||||90.0|97.2|100.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||100|97.2|
72555799|NCT00834132|144642940|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using PROC GLM procedures in SAS, analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Test/Ref Ratio of LS Means x 100|94.81||||||90.0|84.77|106.04|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||106.04|84.77|
72555800|NCT00834132|144642941|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using PROC GLM procedures in SAS, analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Test/Ref Ratio of LS Means x 100|100.89||||||90.0|96.0|106.03|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||106.03|96.00|
72555801|NCT00834132|144642942|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using PROC GLM procedures in SAS, analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Test/Ref Ratio of LS Means x 100|101.14||||||90.0|96.05|106.49|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||106.49|96.05|
72555802|NCT02718963|144642954|OTHER||Mean Difference (Final Values)|0.05|||<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Wilcoxon signed rank test was used to compare the Videofluoroscopic swallowing study(VFSS) kinematic variables, VDS, PAS, and high resolution manometry (HRM) variables between the neuromuscular electrical stimulation session and the control session in swallowing thin fluid and thick fluid for healthy, dysphagic and whole participants. Mann-Whitney test was used to compare the differences of VFSS variables, VDS, PAS, and HRM variables between the healthy participants and dysphagic participants.||||< 0.05
72555803|NCT00836472|144642970|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|96.41||||||90.0|88.43|105.1|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||105.10|88.43|
72375299|NCT04575597|144260998|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|1.1|||||TWO_SIDED|95.0|0.61|2.0||||||||2.00|0.61|
72375300|NCT04575597|144260998|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.83|||||TWO_SIDED|95.0|0.5|1.38||||||||1.38|0.50|
72375301|NCT04575597|144260998|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|1.04|||||TWO_SIDED|95.0|0.9|1.21||||||||1.21|0.90|
72375302|NCT04575597|144260999|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|1.46|||||TWO_SIDED|95.0|0.77|2.76||||||||2.76|0.77|
72375303|NCT04575597|144260999|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|1.76|||||TWO_SIDED|95.0|0.92|3.38||||||||3.38|0.92|
72375304|NCT04575597|144260999|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|1.52|||||TWO_SIDED|95.0|0.81|2.86||||||||2.86|0.81|
72375305|NCT04575597|144260999|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|1.05|||||TWO_SIDED|95.0|0.89|1.24||||||||1.24|0.89|
72375306|NCT04575597|144261000|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|1.33|||||TWO_SIDED|95.0|0.81|2.2||||||||2.20|0.81|
72375307|NCT04575597|144261000|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|1.4|||||TWO_SIDED|95.0|0.85|2.31||||||||2.31|0.85|
72375308|NCT04575597|144261000|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.97|||||TWO_SIDED|95.0|0.57|1.65||||||||1.65|0.57|
72375309|NCT04575597|144261000|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|1.02|||||TWO_SIDED|95.0|0.89|1.18||||||||1.18|0.89|
72375310|NCT04575597|144261001|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.83|||||TWO_SIDED|95.0|0.36|1.91||||||||1.91|0.36|
72375311|NCT04575597|144261001|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|1.37|||||TWO_SIDED|95.0|0.64|2.97||||||||2.97|0.64|
72375312|NCT04575597|144261001|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.86|||||TWO_SIDED|95.0|0.37|2.02||||||||2.02|0.37|
72375313|NCT04575597|144261001|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.92|||||TWO_SIDED|95.0|0.74|1.14||||||||1.14|0.74|
72375314|NCT04575597|144261002|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.68|||||TWO_SIDED|95.0|0.44|1.06||||||||1.06|0.44|
72375315|NCT04575597|144261003|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.21|||||TWO_SIDED|95.0|0.06|0.67||||||||0.67|0.06|
72375316|NCT04575597|144261003|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.33|||||TWO_SIDED|95.0|0.13|0.83||||||||0.83|0.13|
72375317|NCT04575597|144261003|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.27|||||TWO_SIDED|95.0|0.09|0.79||||||||0.79|0.09|
72375318|NCT04575597|144261003|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|1.09|||||TWO_SIDED|95.0|0.87|1.36||||||||1.36|0.87|
72375319|NCT04575597|144261004|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|1.29|||||TWO_SIDED|95.0|0.74|2.23||||||||2.23|0.74|
72375320|NCT04575597|144261004|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.9|||||TWO_SIDED|95.0|0.45|1.8||||||||1.80|0.45|
72375321|NCT04575597|144261004|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|1.02|||||TWO_SIDED|95.0|0.55|1.89||||||||1.89|0.55|
72375322|NCT04575597|144261004|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|1.13|||||TWO_SIDED|95.0|0.94|1.37||||||||1.37|0.94|
72375323|NCT04575597|144261005|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|1.39|||||TWO_SIDED|95.0|0.83|2.33||||||||2.33|0.83|
72375324|NCT04575597|144261005|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.86|||||TWO_SIDED|95.0|0.5|1.48||||||||1.48|0.50|
72375325|NCT04575597|144261005|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.98|||||TWO_SIDED|95.0|0.56|1.72||||||||1.72|0.56|
72375326|NCT04575597|144261005|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|1.2|||||TWO_SIDED|95.0|1.01|1.43||||||||1.43|1.01|
72375327|NCT04575597|144261006|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.79|||||TWO_SIDED|95.0|0.29|2.19||||||||2.19|0.29|
72375328|NCT04575597|144261006|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.91|||||TWO_SIDED|95.0|0.34|2.44||||||||2.44|0.34|
72375329|NCT04575597|144261006|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|1.77|||||TWO_SIDED|95.0|0.74|4.23||||||||4.23|0.74|
72375330|NCT04575597|144261006|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.83|||||TWO_SIDED|95.0|0.67|1.04||||||||1.04|0.67|
72375331|NCT04575597|144261007|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|2.52|||||TWO_SIDED|95.0|0.98|6.53||||||||6.53|0.98|
72375332|NCT04575597|144261007|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.77|||||TWO_SIDED|95.0|0.23|2.52||||||||2.52|0.23|
72375333|NCT04575597|144261007|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.46|||||TWO_SIDED|95.0|0.11|1.84||||||||1.84|0.11|
72375334|NCT04575597|144261007|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.88|||||TWO_SIDED|95.0|0.66|1.16||||||||1.16|0.66|
72375335|NCT04575597|144261008|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|1.23|||||TWO_SIDED|95.0|0.46|3.32||||||||3.32|0.46|
72375336|NCT04575597|144261008|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|1.42|||||TWO_SIDED|95.0|0.54|3.74||||||||3.74|0.54|
72375337|NCT04575597|144261008|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.97|||||TWO_SIDED|95.0|0.34|2.76||||||||2.76|0.34|
72375338|NCT04575597|144261008|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.85|||||TWO_SIDED|95.0|0.66|1.1||||||||1.10|0.66|
72375339|NCT04575597|144261009|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|1.02|||||TWO_SIDED|95.0|0.41|2.52||||||||2.52|0.41|
72375340|NCT04575597|144261009|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.71|||||TWO_SIDED|95.0|0.26|1.9||||||||1.90|0.26|
72375341|NCT04575597|144261009|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|1.24|||||TWO_SIDED|95.0|0.51|3.0||||||||3.00|0.51|
72375342|NCT04575597|144261009|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.9|||||TWO_SIDED|95.0|0.69|1.17||||||||1.17|0.69|
72375343|NCT04575597|144261010|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.8|||||TWO_SIDED|95.0|0.36|1.75||||||||1.75|0.36|
72375344|NCT04575597|144261010|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.73|||||TWO_SIDED|95.0|0.33|1.64||||||||1.64|0.33|
72375345|NCT04575597|144261010|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.71|||||TWO_SIDED|95.0|0.31|1.62||||||||1.62|0.31|
72375346|NCT04575597|144261010|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.94|||||TWO_SIDED|95.0|0.76|1.16||||||||1.16|0.76|
72375347|NCT04575597|144261011|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.59|||||TWO_SIDED|95.0|0.25|1.39||||||||1.39|0.25|
72375348|NCT04575597|144261011|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.83|||||TWO_SIDED|95.0|0.38|1.78||||||||1.78|0.38|
72375349|NCT04575597|144261011|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.59|||||TWO_SIDED|95.0|0.25|1.39||||||||1.39|0.25|
72555804|NCT00836472|144642971|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|98.78||||||90.0|95.14|102.57|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||102.57|95.14|
72555805|NCT00836472|144642972|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|98.52||||||90.0|94.44|102.78|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||102.78|94.44|
72555806|NCT00836472|144642973|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|94.08||||||90.0|89.6|98.77|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||98.77|89.60|
72555807|NCT00836472|144642974|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|96.33||||||90.0|92.6|100.21|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||100.21|92.60|
72555808|NCT00836472|144642975|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|96.01||||||90.0|92.18|100.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||100.00|92.18|
72555809|NCT01695239|144642976|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Regression, Logistic|||||||<0.001
72555810|NCT01695239|144642976|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Regression, Logistic|||||||<0.001
72555811|NCT01695239|144642976|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Regression, Logistic|||||||<0.001
72555812|NCT03552484|144643021|SUPERIORITY||Median Difference (Final Values)|0.05||||0.59|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||Within-group paired t-tests and between-group paired t-tests||||0.59
72555813|NCT03552484|144643022|SUPERIORITY||Mean Difference (Final Values)|-1.43||||0.59|TWO_SIDED|95.0||||Between-group comparison|t-test, 2 sided|||||||0.59
72555814|NCT03552484|144643023|SUPERIORITY||Mean Difference (Final Values)|0.44||||0.62|TWO_SIDED|||||Between-group comparison of change in Multidimensional Caregiver Strain Index|t-test, 2 sided|||||||0.62
72555815|NCT02663349|144643039|SUPERIORITY|||||||0.08|||||||t-test, 2 sided|df = 14||Within sample analysis of change between baseline and 3 month assessment.||||.08
72555816|NCT02663349|144643040|SUPERIORITY|||||||0.69|||||||t-test, 2 sided|||Within sample change between baseline and 6 month assessment.||||.69
72555817|NCT02663349|144643041|SUPERIORITY|||||||0.02|||||||t-test, 2 sided|df=14||Within sample change assessed between baseline and 3-month assessment||||.02
72555818|NCT02663349|144643042|SUPERIORITY|||||||0.34|||||||t-test, 2 sided|df = 14||Change between baseline and 6 month assessment||||.34
72555819|NCT02663349|144643043|SUPERIORITY||||||>|0.05|||||||t-test, 2 sided|||completer analysis of change between baseline and 3-month assessment on the AIHQ Hostility scale||||>.05
72555820|NCT02663349|144643043|SUPERIORITY|||||||0.04|||||||t-test, 2 sided|||Completer analysis to examine within group change between baseline and 3-month assessment on the AIHQ Aggression scale||||.04
72555821|NCT02663349|144643044|SUPERIORITY||||||>|0.05|||||||t-test, 2 sided|||completer analysis of within group change on the AIHQ Hostility scale between baseline and the 6-month assessment||||>.05
72555822|NCT02663349|144643044|SUPERIORITY||||||>|0.05|||||||t-test, 2 sided|||completer analysis of within group change on the AIHQ Aggression scale between baseline and the 6 month assessment||||> .05
72555823|NCT02663349|144643045|SUPERIORITY||||||>|0.05|||||||t-test, 2 sided|df = 15||Change within group between baseline and 3 month assessment on the TASIT total score for part 3||||> .05
72555824|NCT02663349|144643046|SUPERIORITY||||||>|0.05|||||||t-test, 2 sided|df = 15||within group change on the TASIT total score for Part 3 between baseline and the 6 month assessment||||> .05
72555825|NCT02663349|144643047|SUPERIORITY||||||>|0.05|||||||t-test, 2 sided|df = 14||Within group change on SSPA Total Score between baseline and 3-month assessment||||>.05
72555826|NCT02663349|144643048|SUPERIORITY||||||>|0.05|||||||t-test, 2 sided|df = 14||Within group change on the SSPA total score between baseline and 6 month assessment||||> .05
72555827|NCT02663349|144643049|SUPERIORITY||||||>|0.05|||||||t-test, 2 sided|df = 15||Within group change on the First Episode Social Functioning Scale Performance Total score on scales 1-7 between baseline and 3-month follow-up||||> .05
72555828|NCT02663349|144643050|SUPERIORITY||||||>|0.05|||||||t-test, 2 sided|df = 15||Within group change between baseline and 6-month assessment on the First Episode Social Functioning Scale Performance total score on scales 1-7||||> .05
72555829|NCT02663349|144643051|SUPERIORITY|||||||0.15|||||||t-test, 2 sided|df = 13||Within group change on the MCSS Collegial Support scale between Baseline and 3-Month assessments||||.15
72555830|NCT02663349|144643051|SUPERIORITY|||||||0.1|||||||t-test, 2 sided|df = 13||Within group change on the MCSS Task Support scale between baseline and 3-month assessments||||.10
72555831|NCT02663349|144643051|SUPERIORITY||||||>|0.05|||||||t-test, 2 sided|df = 13||Within group change on the MCSS Mentor scale between baseline and the 3-month assessment||||>.05
72555832|NCT02663349|144643051|SUPERIORITY||||||>|0.05|||||||t-test, 2 sided|df = 13||Within group change on the MCSS Coach scale between baseline and the 3 month assessment||||> .05
72555833|NCT02663349|144643052|SUPERIORITY|||||||0.01|||||||t-test, 2 sided|df = 13||Within group change on the MCSS Collegial Support scale between baseline and the 6-month assessment||||.01
72555834|NCT02663349|144643052|SUPERIORITY|||||||0.03|||||||t-test, 2 sided|df = 13||Within group change on the MCSS Task Support scale between baseline and 6-month assessment||||.03
72555835|NCT02663349|144643052|SUPERIORITY||||||>|0.05|||||||t-test, 2 sided|df = 13||Within group change on the MCSS Mentor scale between baseline and the 6-month assessment||||> .05
72555836|NCT02663349|144643052|SUPERIORITY||||||>|0.05|||||||t-test, 2 sided|df = 13||Within group change on the MCSS Coach scale between baseline and the 6-month assessment||||> .05
72555837|NCT02663349|144643053|SUPERIORITY|||||||0.09|||||||t-test, 2 sided|df = 13||Within group change on the VETSS Self Disclosure scale between Baseline and 3-Month Assessment||||.09
72375350|NCT04575597|144261011|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|1.16|||||TWO_SIDED|95.0|0.91|1.48||||||||1.48|0.91|
72375351|NCT04575597|144261012|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.59|||||TWO_SIDED|95.0|0.26|1.34||||||||1.34|0.26|
72375352|NCT04575597|144261012|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.62|||||TWO_SIDED|95.0|0.28|1.37||||||||1.37|0.28|
72375353|NCT04575597|144261012|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.82|||||TWO_SIDED|95.0|0.38|1.74||||||||1.74|0.38|
72375354|NCT04575597|144261012|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.96|||||TWO_SIDED|95.0|0.79|1.21||||||||1.21|0.79|
72375355|NCT04575597|144261013|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|1.19|||||TWO_SIDED|95.0|0.47|3.02||||||||3.02|0.47|
72375356|NCT04575597|144261013|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.8|||||TWO_SIDED|95.0|0.29|2.2||||||||2.20|0.29|
72375357|NCT04575597|144261013|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.89|||||TWO_SIDED|95.0|0.32|2.45||||||||2.45|0.32|
72375358|NCT04575597|144261013|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.83|||||TWO_SIDED|95.0|0.62|1.11||||||||1.11|0.62|
72375359|NCT04575597|144261014|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.82|||||TWO_SIDED|95.0|0.3|2.27||||||||2.27|0.30|
72375360|NCT04575597|144261014|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.21|||||TWO_SIDED|95.0|0.04|1.0||||||||1.00|0.04|
72375361|NCT04575597|144261014|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.66|||||TWO_SIDED|95.0|0.23|1.91||||||||1.91|0.23|
72555838|NCT02663349|144643053|SUPERIORITY|||||||0.12|||||||t-test, 2 sided|df = 13||Within group change on the VETSS Workplace Coping scale between Baseline and 3-Month Assessment||||.12
72375362|NCT04575597|144261014|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.87|||||TWO_SIDED|95.0|0.62|1.23||||||||1.23|0.62|
72375363|NCT04575597|144261015|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.58|||||TWO_SIDED|95.0|0.28|1.2||||||||1.20|0.28|
72375364|NCT04575597|144261015|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.44|||||TWO_SIDED|95.0|0.2|0.95||||||||0.95|0.20|
72375365|NCT04575597|144261015|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.82|||||TWO_SIDED|95.0|0.43|1.59||||||||1.59|0.43|
72375366|NCT04575597|144261015|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.93|||||TWO_SIDED|95.0|0.73|1.19||||||||1.19|0.73|
72375367|NCT04575597|144261016|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.86|||||TWO_SIDED|95.0|0.35|2.11||||||||2.11|0.35|
72375368|NCT04575597|144261016|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.46|||||TWO_SIDED|95.0|0.16|1.34||||||||1.34|0.16|
72375369|NCT04575597|144261016|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|1.18|||||TWO_SIDED|95.0|0.5|2.79||||||||2.79|0.50|
72375370|NCT04575597|144261016|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.99|||||TWO_SIDED|95.0|0.74|1.32||||||||1.32|0.74|
72375371|NCT04575597|144261017|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.97|||||TWO_SIDED|95.0|0.06|15.54||||||||15.54|0.06|
72375372|NCT04575597|144261017|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.0|||||TWO_SIDED|95.0|0.0||NA = Upper limit not reached as no events were recorded||||||||0.00|
72375373|NCT04575597|144261017|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|1.0|||||TWO_SIDED|95.0|0.06|15.99||||||||15.99|0.06|
72555839|NCT02663349|144643054|SUPERIORITY||||||>|0.05|||||||t-test, 2 sided|df = 13||Within group change on VETSS Self Disclosure scale between Baseline and 6 month assessment||||> .05
72555840|NCT02663349|144643054|SUPERIORITY||||||>|0.05|||||||t-test, 2 sided|df = 13||Within group change on VETSS Workplace Coping scale between baseline and the 6 month assessment||||> .05
72555841|NCT00488774|144643056|SUPERIORITY_OR_OTHER|||||||0.467|||||||Chi-squared|||||||0.467
72555842|NCT00488774|144643056|SUPERIORITY_OR_OTHER|||||||0.081|||||||Chi-squared|||||||0.081
72555843|NCT00488774|144643056|SUPERIORITY_OR_OTHER|||||||0.145|||||||Chi-squared|||||||0.145
72555844|NCT00488774|144643057|SUPERIORITY_OR_OTHER|||||||0.832|||||||Chi-squared|||||||0.832
72555845|NCT00488774|144643057|SUPERIORITY_OR_OTHER|||||||0.37|||||||Chi-squared|||||||0.370
72555846|NCT00488774|144643057|SUPERIORITY_OR_OTHER|||||||0.702|||||||Chi-squared|||||||0.702
72555847|NCT00673660|144643081|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||p-Values less than 0.05 were considered statistically significant.|t-test, 2 sided|||Total cholesterol||||<0.001
72555848|NCT00673660|144643081|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||p-Values less than 0.05 were considered statistically significant.|t-test, 2 sided|||LDL cholesterol||||<0.001
72555849|NCT00673660|144643081|SUPERIORITY_OR_OTHER_LEGACY|||||||0.972|TWO_SIDED|||||p-Values less than 0.05 were considered statistically significant.|t-test, 1 sided|||HDL cholesterol||||0.972
72555850|NCT00673660|144643081|SUPERIORITY_OR_OTHER_LEGACY|||||||0.034|TWO_SIDED|||||p-Values less than 0.05 were considered statistically significant.|t-test, 2 sided|||Triglycerides||||0.034
72555851|NCT05099380|144643099|NON_INFERIORITY|Non-inferiority was declared if the lower bound of the 2-sided 95% confidence interval of the mean difference was above -5.|Least-square Mean Difference|3.1|STANDARD_ERROR_OF_MEAN|1.86|||TWO_SIDED|95.0|-0.6|6.7|||Linear Mixed Model|Kenward and Roger method was used for denominator degrees of freedom.|Least-square Mean difference was calculated as Test minus Control|Based on the sample size calculation using a two independent sample t test with a 2-sided type I error of 0.05, there would be enough power (i.e., 80%) for testing non-inferiority of the Test relative to the Control with 286 subjects (143 for each lens group) competing the study assuming the Test was 2 points higher than the Control.||6.7|-0.6|
72555852|NCT05099380|144643100|NON_INFERIORITY|Non-inferiority was declared if the upper bound of the 2-sided 95% confidence interval of the mean difference was below 0.05.|Least-square Mean Difference|0.008|STANDARD_ERROR_OF_MEAN|0.008|||TWO_SIDED|95.0|-0.02|0.01|||Linear Mixed Model|Kenward and Roger method was used for denominator degrees of freedom.|Least-square Mean difference was calculated as Test minus Control|Based on the sample size calculation using a linear mixed model-based method with a 2-sided type I error of 0.05, there would be enough power (i.e., at least 80%) for testing non-inferiority of the Test relative to the Control with 16 subjects (8 for each lens group) competing the study assuming no difference between the Test and the Control.||0.01|-0.02|
72555853|NCT05099380|144643101|NON_INFERIORITY|Non-inferiority was declared if the upper bound of the 95% central posterior credible interval of proportion difference was below 0.05.|Mean Proportion Difference|0.0|STANDARD_DEVIATION|0.002|||TWO_SIDED|95.0|-0.004|0.004|||Bayesian hierarchical model||Proportion difference was calculated as Test minus Control|Based on the sample size calculation using a simulation approach and Bayesian analysis with the 95% central posterior credible interval, there would be enough power (i.e., at least 80%) for assessing non-inferiority of the Test relative to the Control with 240 subjects (120 for each lens group) competing the study assuming no difference between the Test and the Control.||0.004|-0.004|
72555854|NCT05099380|144643102|NON_INFERIORITY|Non- inferiority was declared if the upper bound of the 95% central posterior credible interval of proportion difference was below 0.1.|Mean Proportion Difference|0.0|STANDARD_DEVIATION|0.002|||TWO_SIDED|95.0|-0.004|0.004|||Bayesian hierarchical model||Proportion difference was calculated as Test minus Control|Based on the sample size calculation using a simulation approach and Bayesian analysis with the 95% central posterior credible interval, there would be enough power (i.e., at least 80%) for assessing non-inferiority of the Test relative to the Control with 140 subjects (70 for each lens group) competing the study assuming no difference between the Test and the Control.||0.004|-0.004|
72555855|NCT05099380|144643103|NON_INFERIORITY|Non-inferiority was declared if the lower bound of the 2-sided 95% confidence interval of the mean difference was above -5.|Least-square Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|2.35|||TWO_SIDED|95.0|-4.8|4.5|||Linear Mixed Model|Kenward and Roger method was used for denominator degrees of freedom.|Least-square Mean difference was calculated as Test minus Control|Based on the sample size calculated for the primary endpoints (i.e., 286 subjects with 143 per lens group), assuming the Test was 2 points higher than the Control, the estimated statistical power for testing non-inferiority of the Test relative to the Control was 73% for CLUE comfort using a two independent sample t test with a 2-sided type I error of 0.05.||4.5|-4.8|
72555856|NCT05099380|144643104|NON_INFERIORITY|Non-inferiority was declared if the lower bound of the 2-sided 95% confidence interval of the mean difference was above -5.|Least-square Mean Difference|-1.9|STANDARD_ERROR_OF_MEAN|2.13|||TWO_SIDED|95.0|-6.0|2.3|||Linear Mixed Model|Kenward and Roger method was used for denominator degrees of freedom.|Least-square Mean difference was calculated as Test minus Control|Based on the sample size calculated for the primary endpoints (i.e., 286 subjects with 143 per lens group), assuming the Test was 2 points lower than the Control, the estimated statistical power for testing non-inferiority of the Test relative to the Control was 23% for CLUE handling using a two independent sample t test with a 2-sided type I error of 0.05.||2.3|-6.0|
72555857|NCT05099380|144643105|NON_INFERIORITY|Non-inferiority was declared if the lower bound of the 2-sided 95% confidence interval of the odds ratio was greater than 0.67.|Odds Ratio (OR)|1.34|||||TWO_SIDED|95.0|0.83|2.16|||Linear Mixed Model||Odds Ratio was calculated as Test over Control|"Based on the sample size calculated for the primary endpoints (i.e., 286 subjects with 143 per lens group), assuming the percentage of Excellent rating for the Test was 10% higher than the Control, the estimated statistical power for testing non-inferiority of the Test relative to the Control was 93% using a Pearson chi-square test for two proportions with a 2-sided type I error of 0.05."||2.16|0.83|
72555858|NCT05099380|144643106|SUPERIORITY|Superiority was declared if the lower bound of the 2-sided 95% confidence interval of the preference ratio was greater than 1.|Preference Ratio|2.4|||||TWO_SIDED|95.0|1.4|4.1|||Linear Mixed Model||Preference ratio was calculated as Study lens over Habitual lens within the Test lens group.|Based on the sample size calculated for the primary endpoints (i.e., 286 subjects with 143 per lens group), assuming the percentage of subjects preferring Study lens was 20% higher than preferring Habitual lens in the Test lens group, the estimated statistical power for testing superiority of the Test relative to the Habitual was 88% using a simulation approach with a 2-sided type I error of 0.05.||4.10|1.40|
72555859|NCT00835263|144643131|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|103.23||||||90.0|100.78|105.73|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||105.73|100.78|
72375374|NCT04575597|144261017|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.76|||||TWO_SIDED|95.0|0.46|1.25||||||||1.25|0.46|
72375375|NCT04575597|144261018|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|1.49|||||TWO_SIDED|95.0|0.58|3.83||||||||3.83|0.58|
72375376|NCT04575597|144261018|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|1.14|||||TWO_SIDED|95.0|0.42|3.05||||||||3.05|0.42|
72375377|NCT04575597|144261018|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|1.49|||||TWO_SIDED|95.0|0.57|3.93||||||||3.93|0.57|
72375378|NCT04575597|144261018|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.82|||||TWO_SIDED|95.0|0.61|1.1||||||||1.10|0.61|
72375379|NCT04575597|144261019|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.36|||||TWO_SIDED|95.0|0.11|1.21||||||||1.21|0.11|
72375380|NCT04575597|144261019|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.52|||||TWO_SIDED|95.0|0.2|1.36||||||||1.36|0.20|
72375381|NCT04575597|144261019|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.74|||||TWO_SIDED|95.0|0.29|1.89||||||||1.89|0.29|
72375382|NCT04575597|144261019|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.91|||||TWO_SIDED|95.0|0.68|1.2||||||||1.20|0.68|
72375383|NCT04575597|144261020|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.35|||||TWO_SIDED|95.0|0.09|1.33||||||||1.33|0.09|
72375384|NCT04575597|144261020|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.8|||||TWO_SIDED|95.0|0.3|2.15||||||||2.15|0.30|
72375385|NCT04575597|144261020|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.51|||||TWO_SIDED|95.0|0.18|1.48||||||||1.48|0.18|
72375386|NCT04575597|144261020|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.81|||||TWO_SIDED|95.0|0.62|1.04||||||||1.04|0.62|
72375387|NCT04575597|144261021|OTHER|Odds ratio was based on the proportional odds model with WHO-11 score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|Odds Ratio (OR)|3.04|||||TWO_SIDED|95.0|0.59|15.59||||||||15.59|0.59|
72375388|NCT04575597|144261021|OTHER|Odds ratio was based on the proportional odds model with WHO-11 score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|Odds Ratio (OR)|1.33|||||TWO_SIDED|95.0|0.29|6.16||||||||6.16|0.29|
72375389|NCT04575597|144261021|OTHER|Odds ratio was based on the proportional odds model with WHO-11 score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|Odds Ratio (OR)|0.37|||||TWO_SIDED|95.0|0.09|1.44||||||||1.44|0.09|
72375390|NCT04575597|144261021|OTHER|Odds ratio was based on the proportional odds model with WHO-11 score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|Odds Ratio (OR)|1.19|||||TWO_SIDED|95.0|0.62|2.3||||||||2.30|0.62|
72375391|NCT04575597|144261022|OTHER|Odds ratio was based on the proportional odds model with WHO-11 score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|Odds Ratio (OR)|3.67|||||TWO_SIDED|95.0|1.14|11.88||||||||11.88|1.14|
72375392|NCT04575597|144261022|OTHER|Odds ratio was based on the proportional odds model with WHO-11 score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|Odds Ratio (OR)|1.16|||||TWO_SIDED|95.0|0.34|3.98||||||||3.98|0.34|
72375393|NCT04575597|144261022|OTHER|Odds ratio was based on the proportional odds model with WHO-11 score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|Odds Ratio (OR)|0.85|||||TWO_SIDED|95.0|0.27|2.68||||||||2.68|0.27|
72375394|NCT04575597|144261022|OTHER|Odds ratio was based on the proportional odds model with WHO-11 score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|Odds Ratio (OR)|1.52|||||TWO_SIDED|95.0|0.96|2.39||||||||2.39|0.96|
72375395|NCT04575597|144261023|OTHER|Odds ratio was based on the proportional odds model with WHO-11 score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|Odds Ratio (OR)|1.68|||||TWO_SIDED|95.0|0.82|3.45||||||||3.45|0.82|
72375396|NCT04575597|144261023|OTHER|Odds ratio was based on the proportional odds model with WHO-11 score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|Odds Ratio (OR)|1.13|||||TWO_SIDED|95.0|0.55|2.33||||||||2.33|0.55|
72375397|NCT04575597|144261023|OTHER|Odds ratio was based on the proportional odds model with WHO-11 score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|Odds Ratio (OR)|0.59|||||TWO_SIDED|95.0|0.27|1.29||||||||1.29|0.27|
72395086|NCT00720434|144296638|SUPERIORITY_OR_OTHER||Difference in Proportions|0.0|||||TWO_SIDED|95.0|-0.507|0.507||||||Week 72: The difference in proportions between treatment groups presented along with 95% CI, were based on exact method for small samples from the binomial distribution.||0.5070|-0.5070|
72375398|NCT04575597|144261023|OTHER|Odds ratio was based on the proportional odds model with WHO-11 score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|Odds Ratio (OR)|1.58|||||TWO_SIDED|95.0|1.14|2.2||||||||2.20|1.14|
72375399|NCT04575597|144261024|OTHER|Odds ratio was based on the proportional odds model with WHO-11 score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|Odds Ratio (OR)|1.41|||||TWO_SIDED|95.0|0.73|2.73||||||||2.73|0.73|
72375400|NCT04575597|144261024|OTHER|Odds ratio was based on the proportional odds model with WHO-11 score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|Odds Ratio (OR)|1.0|||||TWO_SIDED|95.0|0.52|1.94||||||||1.94|0.52|
72375401|NCT04575597|144261024|OTHER|Odds ratio was based on the proportional odds model with WHO-11 score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|Odds Ratio (OR)|0.67|||||TWO_SIDED|95.0|0.34|1.32||||||||1.32|0.34|
72375402|NCT04575597|144261024|OTHER|Odds ratio was based on the proportional odds model with WHO-11 score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|Odds Ratio (OR)|1.36|||||TWO_SIDED|95.0|1.03|1.78||||||||1.78|1.03|
72375403|NCT04575597|144261025|OTHER|Odds ratio was based on the proportional odds model with WHO-11 score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|Odds Ratio (OR)|0.76|||||TWO_SIDED|95.0|0.35|1.66||||||||1.66|0.35|
72375404|NCT04575597|144261025|OTHER|Odds ratio was based on the proportional odds model with WHO-11 score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|Odds Ratio (OR)|0.82|||||TWO_SIDED|95.0|0.38|1.79||||||||1.79|0.38|
72375405|NCT04575597|144261025|OTHER|Odds ratio was based on the proportional odds model with WHO-11 score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|Odds Ratio (OR)|0.82|||||TWO_SIDED|95.0|0.37|1.81||||||||1.81|0.37|
72375406|NCT04575597|144261025|OTHER|Odds ratio was based on the proportional odds model with WHO-11 score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|Odds Ratio (OR)|1.04|||||TWO_SIDED|95.0|0.84|1.29||||||||1.29|0.84|
72555860|NCT00835263|144643132|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|103.31||||||90.0|100.75|105.93|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||105.93|100.75|
72555861|NCT00835263|144643133|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|102.14||||||90.0|100.06|104.26|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||104.26|100.06|
72555862|NCT01604941|144643145|SUPERIORITY_OR_OTHER_LEGACY|||||||0.296|TWO_SIDED|||||The P-value is from analysis of paired t-test at post treatment timepoint vs. Baseline.|paired t-test|||Analysis of Week 12 for 50 mg/kg/d dosing||||0.2960
72555863|NCT01604941|144643145|SUPERIORITY_OR_OTHER_LEGACY|||||||0.04|TWO_SIDED|||||The P-value is from analysis of paired t-test at post treatment timepoint vs. Baseline.|paired t-test|||Analysis of Week 12 for all participants with BID dosing||||0.0400
72555864|NCT01604941|144643145|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6303|TWO_SIDED|||||The P-value is from analysis of paired t-test at post treatment timepoint vs. Baseline.|paired t-test|||Analysis of Week 24 for all participants with BID dosing||||0.6303
72555865|NCT01604941|144643146|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0365|TWO_SIDED|||||P-value is from analysis of paired t-test at post treatment timepoint vs. Baseline.|paired t-test|||Analysis of Week 12 for 50 mg/kg/d dosing||||0.0365
72555866|NCT01604941|144643146|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0019|TWO_SIDED|||||The P-value is from analysis of paired t-test at post treatment timepoint vs. Baseline.|paired t-test|||Analysis of Week 12 for all participants with BID dosing||||0.0019
72555867|NCT01604941|144643146|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1695|TWO_SIDED|||||The P-value is from analysis of paired t-test at post treatment timepoint vs. Baseline.|paired t-test|||Analysis of Week 24 for all participants with BID dosing||||0.1695
72375407|NCT04575597|144261026|OTHER|Difference in rates % and associated CIs were based on the Miettinen \& Nurminen method stratified by randomization strata. Unknown survival status at Day 29 was treated as failure.|Difference in Rates %|-3.0|||||TWO_SIDED|95.0|-5.9|-0.1||||||||-0.1|-5.9|
72375408|NCT01976988|144261051|SUPERIORITY_OR_OTHER|||||||0.72|||||||Fisher Exact|||||||0.72
72375409|NCT01976988|144261052|SUPERIORITY_OR_OTHER|||||||0.36|||||||Fisher Exact|||||||0.36
72375410|NCT01976988|144261053|SUPERIORITY_OR_OTHER|||||||0.03|||||||Fisher Exact|||||||0.03
72375411|NCT01976988|144261054|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||||||1
72375412|NCT01976988|144261055|SUPERIORITY_OR_OTHER|||||||0.46|||||||Wilcoxon (Mann-Whitney)|||||||0.46
72375413|NCT01976988|144261056|SUPERIORITY_OR_OTHER|||||||0.34|||||||Fisher Exact|||||||0.34
72375414|NCT03207438|144261057|SUPERIORITY||Hazard Ratio (HR)|1.39|STANDARD_ERROR_OF_MEAN|0.06|<|0.001|TWO_SIDED||||||Regression, Cox|||Main effect of quetiapine vs. placebo||||<.001
72375415|NCT03207438|144261057|SUPERIORITY||Hazard Ratio (HR)|1.15|STANDARD_ERROR_OF_MEAN|0.1||0.18|TWO_SIDED||||||Regression, Cox|||Interaction - treatment condition x melancholia||||.18
72375416|NCT03207438|144261057|SUPERIORITY||Hazard Ratio (HR)|1.46|STANDARD_ERROR_OF_MEAN|0.06|<|0.001|TWO_SIDED||||||Regression, Cox|Adjusted for baseline depression severity, Study number (1-4), and melancholic-by-time interaction.||Main effect of quetiapine vs. placebo||||<.001
72375417|NCT03207438|144261057|SUPERIORITY||Hazard Ratio (HR)|1.17|STANDARD_ERROR_OF_MEAN|0.1||0.14|TWO_SIDED||||||Regression, Cox|Adjusted for baseline depression severity, Study number (1-4), and melancholic-by-time interaction.||Interaction - treatment condition by melancholia||||.14
72375418|NCT03207438|144261058|SUPERIORITY||Hazard Ratio (HR)|1.35|STANDARD_ERROR_OF_MEAN|0.06|<|0.001|TWO_SIDED||||||Regression, Cox|||Main effect of quetiapine vs. placebo||||<.001
72375419|NCT03207438|144261058|SUPERIORITY||Hazard Ratio (HR)|1.16|STANDARD_ERROR_OF_MEAN|0.11||0.17|TWO_SIDED||||||Regression, Cox|||Interaction - treatment condition x melancholia||||.17
72375420|NCT03207438|144261058|SUPERIORITY||Hazard Ratio (HR)|1.3|STANDARD_ERROR_OF_MEAN|0.06|<|0.001|TWO_SIDED||||||Regression, Cox|Adjusted for baseline depression severity, Study number (1-4), and melancholic-by-time interaction.||Main effect of quetiapine vs. placebo||||<.001
72375421|NCT03207438|144261058|SUPERIORITY||Hazard Ratio (HR)|1.18|STANDARD_ERROR_OF_MEAN|0.11||0.13|TWO_SIDED||||||Regression, Cox|Adjusted for baseline depression severity, Study number (1-4), and melancholic-by-time interaction.||Interaction - treatment condition by melancholia||||.13
72375422|NCT03207438|144261059|SUPERIORITY|||||||0.33|||||||Fisher's exact test|||Day 4 - Fisher's exact test comparing the proportion of quetiapine responders in each sleep subgroup|An exact OR could not be estimated by R; the 95% confidence interval was 0.31 to infinity, p = .33.|||.33
72375423|NCT03207438|144261059|SUPERIORITY||Odds Ratio (OR)|1.3||||0.44|TWO_SIDED||||||Fisher's exact test||The exact limits of 95% confidence interval could not be estimated, it was reported as 0.40 to infinity.|Week 1 - Fisher's exact test comparing the proportion of quetiapine responders in each sleep subgroup||||.44
72375424|NCT03207438|144261059|SUPERIORITY||Chi-squared|0.38||||0.73|TWO_SIDED||||||Chi-squared, Corrected|||Week 2 - Chi-squared test comparing the proportion of quetiapine responders in each sleep subgroup||||.73
72375425|NCT03207438|144261059|SUPERIORITY||Chi-squared|1.5||||0.11|TWO_SIDED||||||Chi-squared, Corrected|||Week 4 - Chi-squared test comparing the proportion of quetiapine responders in each sleep subgroup||||.11
72375426|NCT03207438|144261059|SUPERIORITY||Chi-squared|0.001||||0.5|TWO_SIDED||||||Chi-squared, Corrected||The actual estimated Chi-squared statistic was 6.35(10\^-31)|Week 6 - Chi-squared test comparing the proportion of quetiapine responders in each sleep subgroup||||.50
72375427|NCT03207438|144261060|SUPERIORITY||Chi-squared|0.001||||0.5|TWO_SIDED||||||Chi-squared, Corrected||Estimated chi-squared statistic was 1.88(10\^-29).|Day 4 - chi-squared test comparing response rates between groups.||||.5
72375428|NCT03207438|144261060|SUPERIORITY||Chi-squared|3.3||||0.03|TWO_SIDED||||||Chi-squared, Corrected|||Week 1 - chi-squared test comparing response rates between groups.||||.03
72375429|NCT03207438|144261060|SUPERIORITY||Chi-squared|3.87||||0.02|TWO_SIDED||||||Chi-squared, Corrected|||Week 2 - chi-squared test comparing response rates between groups.||||.02
72375430|NCT03207438|144261060|SUPERIORITY||Chi-squared|0.62||||0.22|TWO_SIDED||||||Chi-squared, Corrected|||Week 4 - chi-squared test comparing response rates between groups.||||.22
72375431|NCT03207438|144261060|SUPERIORITY||Chi-squared|2.45||||0.059|TWO_SIDED||||||Chi-squared, Corrected|||Week 6 - chi-squared test comparing response rates between groups.||||.059
72375432|NCT01512667|144261088|NON_INFERIORITY_OR_EQUIVALENCE|Similarity will be concluded if the GMR (severe renal insufficiency / healthy) is contained within the interval \[0.40, 2.50\].|GMR|1.6|||||TWO_SIDED|90.0|1.15|2.23||||||Natural log-transformed plasma values were analyzed using an analysis of covariance (ANCOVA) model with a categorical factor for population (severe renal insufficiency participants, healthy matched control participants) and continuous covariates for age and body mass index (BMI). Data are back transformed to geometric least-squares mean ratio (GMR) (severe renal insufficiency / healthy) and 90% confidence intervals.||2.23|1.15|
72375433|NCT01512667|144261089|SUPERIORITY_OR_OTHER||GMR|1.46|||||TWO_SIDED|90.0|1.18|1.81||||||Natural log-transformed plasma values were analyzed using an ANCOVA model with a categorical factor for population (severe renal insufficiency participants, healthy matched control participants) and continuous covariates for age and BMI. Data are back transformed to GMR (severe renal insufficiency / healthy) and 90% confidence intervals.||1.81|1.18|
72375434|NCT00853996|144261104|OTHER||||||<|0.001||||||No adjustment for multiple comparisons since this was primary endpoint. A priori threshold for statistical significance was set at \<0.05.|Wilcoxon (Mann-Whitney)|||||||<0.001
72375435|NCT00853996|144261105|OTHER|||||||0.067||||||No adjustment for multiple comparisons. A priori threshold for statistical significance was set at \<0.05.|Wilcoxon (Mann-Whitney)|||||||0.067
72375436|NCT00853996|144261106|OTHER|||||||0.001||||||No adjustment for multiple comparisons. A priori threshold for statistical significance was set at \<0.05|Wilcoxon (Mann-Whitney)|||||||0.001
72375437|NCT00853996|144261107|OTHER|||||||0.002||||||No adjustment for multiple comparisons. A priori threshold for statistical significance was set at \<0.05|Wilcoxon (Mann-Whitney)|||||||0.002
72375438|NCT00853996|144261108|OTHER|||||||0.002||||||No adjustment for multiple comparisons. A priori threshold for statistical significance set at 0.05|Wilcoxon (Mann-Whitney)|||||||0.002
72375439|NCT00770146|144261116|SUPERIORITY_OR_OTHER||||||<|0.001||||||Statistical significance was concluded if p ≤ 0.05.|Wilcoxon (Mann-Whitney)|||Based upon prior clinical study experience with mipomersen, it was estimated that the standard deviation of the percent change in LDL-C is approximately 22%. With at least 20 patients in the control group and 40 patients in the mipomersen-treated group, this study would have at least 90% power to detect a 20% difference between the 2 groups.||||<0.001
72375440|NCT00770146|144261118|SUPERIORITY_OR_OTHER||||||<|0.001||||||Inflation of type 1 error was controlled by specifying a small number of secondary parameters and a sequential inferential approach in which inferential conclusions about each successive parameter required statistical significance of the prior one.|Wilcoxon (Mann-Whitney)|||||||<0.001
72375441|NCT00770146|144261120|SUPERIORITY_OR_OTHER||||||<|0.001||||||Inflation of type 1 error was controlled by specifying a small number of secondary parameters and a sequential inferential approach in which inferential conclusions about each successive parameter required statistical significance of the prior one.|t-test, 2 sided|||||||<0.001
72375442|NCT00770146|144261122|SUPERIORITY_OR_OTHER||||||<|0.001||||||Inflation of type 1 error was controlled by specifying a small number of secondary parameters and a sequential inferential approach in which inferential conclusions about each successive parameter required statistical significance of the prior one.|Wilcoxon (Mann-Whitney)|||||||<0.001
72375443|NCT00770146|144261124|SUPERIORITY_OR_OTHER||||||<|0.001||||||No adjustments were made for tertiary parameters.|Wilcoxon (Mann-Whitney)|||||||<0.001
72375444|NCT00770146|144261126|SUPERIORITY_OR_OTHER|||||||0.977||||||No adjustments were made for tertiary parameters.|t-test, 2 sided|||||||0.977
72375445|NCT00770146|144261128|SUPERIORITY_OR_OTHER||||||<|0.001||||||No adjustments were made for tertiary parameters.|t-test, 2 sided|||||||<0.001
72375446|NCT00770146|144261130|SUPERIORITY_OR_OTHER||||||<|0.001||||||No adjustments were made for tertiary parameters.|Wilcoxon (Mann-Whitney)|||||||<0.001
72375447|NCT00770146|144261132|SUPERIORITY_OR_OTHER||||||<|0.001||||||No adjustments were made for tertiary parameters.|t-test, 2 sided|||||||<0.001
72375448|NCT00770146|144261134|SUPERIORITY_OR_OTHER|||||||0.032||||||No adjustments were made for tertiary parameters.|t-test, 2 sided|||||||0.032
72375449|NCT00816023|144261141|SUPERIORITY_OR_OTHER|||||||0.474||95.0|||||Jonckheere-Terpstra|||||||0.474
72375450|NCT05027971|144261151|OTHER||Proportion by cohort|0.02|||||TWO_SIDED|95.0|0.002|0.07||||||||.07|.002|
72375451|NCT05027971|144261152|OTHER||Proportion by cohort|0.03|||||TWO_SIDED|95.0|0.006|0.084||||||||.084|.006|
72375452|NCT05027971|144261153|OTHER||Proportion by cohort|0.667|||||TWO_SIDED|95.0|0.553|0.768||||||||.768|.553|
72375453|NCT05027971|144261154|OTHER||Mean Difference (Final Values)|-15.8|||||TWO_SIDED|95.0|-17.4|-14.2||||||||-14.2|-17.4|
72375454|NCT05027971|144261157|OTHER||Proportion by cohort|1.0|||||TWO_SIDED|95.0|0.963|1.0||||||||1|.963|
72375455|NCT05027971|144261158|OTHER||Proportion by cohort|1.0|||||TWO_SIDED|95.0|0.963|1.0||||||||1|.963|
72375456|NCT05027971|144261159|OTHER||Proportion by cohort|1.0|||||TWO_SIDED|95.0|0.963|1.0||||||||1|.963|
72375457|NCT05027971|144261160|OTHER||Proportion by cohort|0.889|||||TWO_SIDED|95.0|0.81|0.943||||||||.943|.810|
72375458|NCT05027971|144261161|OTHER||Mean Difference (Final Values)|15.0|||||TWO_SIDED|95.0|11.3|18.6||||||||18.6|11.3|
72375459|NCT05027971|144261162|OTHER||Mean Difference (Final Values)|-3.4|||||TWO_SIDED|95.0|-3.9|-2.9||||||||-2.9|-3.9|
72375460|NCT05027971|144261163|OTHER||Proportion by cohort|1.0|||||TWO_SIDED|95.0|0.963|1.0||||||||1|.963|
72375461|NCT02486627|144261164|NON_INFERIORITY|95% CIs for the difference in cure rates were calculated using the Newcombe method with continuity correction.|Difference|-3.4|||||TWO_SIDED|95.0|-10.0|3.1||||||||3.1|-10|
72375462|NCT02486627|144261165|NON_INFERIORITY|95% CIs for the difference in cure rates were calculated using the Newcombe method with continuity correction.|Difference|11.6|||||TWO_SIDED|95.0|2.7|20.3||||||||20.3|2.7|
72375463|NCT00445588|144261195|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.85||||0.4|TWO_SIDED|95.0|0.6|1.3||cox regression model was used to estimate the HR of death compared to NABTT historical control with same histology, adjusted for age, KPS, and surgical procedure|Regression, Cox|cox regression model used to estimate the HR of death compared to NABTT historical control same histology, adjusted for age, KPS, surgical procedure||The overall failure rate will be estimated by dividing the number of events (death) with the total exposure time in the study cohort. 95% confidence intervals and median time of survival will be calculated using standard methods.||1.3|0.6|0.4
72375464|NCT03554486|144261197|OTHER|||||||0.051|||||||t-test, 2 sided|||||||0.051
72375465|NCT03554486|144261198|OTHER|||||||0.17|||||||t-test, 2 sided|||||||0.17
72375466|NCT03554486|144261199|OTHER|||||||0.74|||||||t-test, 2 sided|||||||0.74
72375467|NCT01738477|144261217|NON_INFERIORITY|To assess the non-inferiority of the second dose of Boostrix (Boostrix 2 Group) minus first dose of Boostrix (Boostrix 1 Group) for anti-diphtheria. Objective of non-inferiority was considered to be met if the lower limit (LL) of the 95% confidence interval (CI) was greater than, or equal to -10%.|Mean Difference (Final Values)|0.0||||||95.0|-3.25|9.95||||||Non-inferiority in terms of seroprotection rates to diphtheria.||9.95|-3.25|
72375468|NCT01738477|144261217|NON_INFERIORITY|To assess the non-inferiority of the second dose of Boostrix (Boostrix 2 Group) minus first dose of Boostrix (Boostrix 1 Group) for anti-tetanus. Objective of non-inferiority was considered to be met if the LL of the 95% CI was above -10%.|Mean Difference (Final Values)|0.0||||||95.0|-3.25|9.95||||||Non-inferiority in terms of seroprotection rates to tetanus.||9.95|-3.25|
72375469|NCT00029146|144261308|SUPERIORITY_OR_OTHER||Difference in estimated 2 yr rates|1.7||||0.78||95.0|-10.4|13.8|||2-sided z-statistic|The difference in estimated rates divided by the standard error of that difference was compared to a standard unit normal distribution.|Positive indicates lower rate in surgical group|Rates for each group were based on product limit estimates of 2-year rates and their standard errors. The test statistic was calculated as the difference in estimated rates divided by the standard error of that difference. The 2-sided z-statistic was compared to a standard unit normal distribution.The study was terminated early for futility after 195 of the planned 372 participants were enrolled.||13.8|-10.4|0.78
72375470|NCT00029146|144261309|SUPERIORITY_OR_OTHER||Difference in estimated 2 yr rates|3.5||||0.59|TWO_SIDED|95.0|-9.2|16.1|||2-sided z-statistic|The difference in estimated rates divided by the standard error of that difference was compared to a standard unit normal distribution.|Positive indicates lower rate in surgical group|Rates for each group were based on product limit estimates of 2-year rates and their standard errors.||16.1|-9.2|0.59
72375471|NCT00029146|144261310|SUPERIORITY_OR_OTHER||Difference in estimated 2 yr rates|-3.2||||0.27|TWO_SIDED|95.0|-9.0|2.6|||2-sided z-statistic|The difference in estimated rates divided by the standard error of that difference was compared to a standard unit normal distribution.|Negative indicates lower rate in non-surgical group|Rates for each group were based on product limit estimates of 2-year rates and their standard errors. The test statistic was calculated as the difference in estimated rates divided by the standard error of that difference.||2.6|-9.0|0.27
72375472|NCT00029146|144261311|SUPERIORITY_OR_OTHER||Difference in estimated 2 yr rates|1.3||||0.5|TWO_SIDED|95.0|-2.5|5.2|||2-sided z-statistic|The difference in estimated rates divided by the standard error of that difference was compared to a standard unit normal distribution.|Positive indicates lower rate in surgical group|Rates for each group were based on product limit estimates of 2-year rates and their standard errors. The test statistic was calculated as the difference in estimated rates divided by the standard error of that difference.||5.2|-2.5|0.50
72375473|NCT00029146|144261312|SUPERIORITY_OR_OTHER||Difference in estimated 2 yr rates|4.0||||0.13|TWO_SIDED|95.0|-1.2|9.7|||2-sided z-statistic|The difference in estimated rates divided by the standard error of that difference was compared to a standard unit normal distribution.|Positive indicates lower rate in surgical group|Rates for each group were based on product limit estimates of 2-year rates and their standard errors. The test statistic was calculated as the difference in estimated rates divided by the standard error of that difference.||9.7|-1.2|0.13
72375474|NCT00029146|144261313|SUPERIORITY_OR_OTHER||Difference in estimated 2 yr rates|6.5||||0.33|TWO_SIDED|95.0|-6.5|19.6|||2-sided z-statistic|The difference in estimated rates divided by the standard error of that difference was compared to a standard unit normal distribution.|Positive indicates lower rate in surgical group|Rates for each group were based on product limit estimates of 2-year rates and their standard errors. The test statistic was calculated as the difference in estimated rates divided by the standard error of that difference.||19.6|-6.5|.33
72375475|NCT00029146|144261314|SUPERIORITY_OR_OTHER||Difference in estimated 2 yr rates|-6.6||||0.41|TWO_SIDED|95.0|-20.6|7.3|||Fisher Exact||Negative indicates lower rate in non-surgical group. In this case, lower rate is worse since Rankin 0-1 indicates a good outcome.|||7.3|-20.6|0.41
72375476|NCT00029146|144261315|SUPERIORITY_OR_OTHER||Difference in estimated 2 yr rates|4.4||||0.7|TWO_SIDED|95.0|-8.2|16.9|||Fisher Exact||Positive indicates lower rate in surgical group In this case, lower rate is worse since Rankin 0-2 indicates a good outcome.|||16.9|-8.2|0.70
72375477|NCT00029146|144261316|SUPERIORITY_OR_OTHER|||||||0.85||95.0|||||Fisher's Exact Test|||||||0.85
72375478|NCT00029146|144261317|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.24||||0.13|TWO_SIDED|95.0|-0.54|0.07|||t-test, 2 sided||Negative indicates lower score in non-surgical group.A higher score indicates better quality of life|||0.07|-0.54|0.13
72375479|NCT00029146|144261318|SUPERIORITY_OR_OTHER||Difference in estimated 2 yr rates|1.5||||0.81|TWO_SIDED|95.0|-10.7|13.7|||2-sided z-statistic|The difference in estimated rates divided by the standard error of that difference was compared to a standard unit normal distribution.||Rates for each group were based on product limit estimates of 2-year rates and their standard errors. The test statistic was calculated as the difference in estimated rates divided by the standard error of that difference.||13.7|-10.7|0.81
72375480|NCT00043550|144261322|SUPERIORITY|The proposed sample size had at least 80% power to detect effect sizes of 0.36 between the two active treatment conditions and placebo during the active phase. These power calculations were based on a priori values of within-subject correlation of 0.50, 10% attrition, and 6 assessment points.|Slope|1.0||||0.95|TWO_SIDED|||||Overall significant effect for treatment, as well as the two moderating effects, used a Bonferroni-corrected alpha level of 0.0167 (0.05/3).|HLM|||Comparison of conditions||||.95
72375481|NCT00043550|144261322|SUPERIORITY||||||<|0.0001|||||||HLM|||effects of conditions over time||||<.0001
72375482|NCT00043550|144261322|SUPERIORITY||Slope|0.03|||||TWO_SIDED|95.0|-0.35|0.41||||||||.41|-.35|
72375483|NCT00043550|144261322|SUPERIORITY||Slope|0.06|||||TWO_SIDED|95.0|-0.33|0.45||||||||.45|-.33|
72375484|NCT01143701|144261335|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.54|||<|0.05|TWO_SIDED|95.0|-5.89|-1.19|||Mixed Models Analysis|||Utilizing the full sample (n=577), an intent-to-treat analyses was conducted comparing patient outcomes across intervention and control groups using a three-level mixed model. Baseline ratings were entered as a covariate. Post-baseline ratings collected closest to 12-months post-baseline were entered as dependent variables.||-1.19|-5.89|<.05
72375485|NCT01143701|144261336|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.48|||<|0.05|TWO_SIDED|95.0|-4.71|1.75|||Mixed Models Analysis|||An intent-to-treat analyses was conducted comparing patient outcomes across intervention and control groups using a three-level mixed model. Baseline ratings were entered as a covariate. Post-baseline ratings collected closest to 12-months post-baseline were entered as dependent variables.||1.75|-4.71|<0.05
72375486|NCT02564432|144261363|EQUIVALENCE|This is not a randomized clinical trial but is an observational study, each patient's thigh skin site served as the control.|Base mean abundance|0.03|||<|0.05|TWO_SIDED|||||The reported p-value was calculated.|Unweighted UniFrac (qualitative)|Both weighted and unweighted UniFrac were calculated; weighted UniFrac is calculated to be p = 0.398 while unweighted UniFrac was P\<0.03|Differential abundance of Staphylococcus aureus in the stoma calculated by Log2 fold change (y-axis) versus base mean abundance (x-axis)|Sample similarity was calculated using the statistical comparisons of community composition.||||<0.05
72375487|NCT02564432|144261363|OTHER|"In this study, dissimilarities between the stomal and healthy thigh skins were tested.~Observational study. Used only for visualizing trends in the data."|PERMANOVA|0.001|||<|0.005|TWO_SIDED|||||Each stomal community type was distinguished by both its diversity and taxonomic composition|Bray-Curtis dissimilarities|Nonmetric multidimensional scaling (NMDS) of Bray-Curtis dissimilarities|||Loess Regression was used to visualize temporal trends in the Shannnon Diversity and relative abundance of microbes (Staphylococcus, Streptococcus, Corynebacterium, and obligate anaerobes).|||<0.005
72375488|NCT00730028|144261365|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.2||||0.7688|TWO_SIDED|95.0|-7.6|5.1||Adjustments for multiple comparisons were made using a Bonferroni correction.|Fisher Exact||The mean difference is determined by the cure rate of TMP-SMX minus Clindamycin.|Primary null hypothesis: Clindamycin and TMP-SMX have equal rates of cure in the treatment of cellulitis/larger abscess at the Test of Cure (TOC) visit.||5.1|-7.6|0.7688
72375489|NCT00730028|144261365|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2||||1|TWO_SIDED|95.0|-5.4|5.1||Adjustments for multiple comparisons were made using a Bonferroni correction.|Fisher Exact||The mean difference is determined by the cure rate of TMP-SMX minus Clindamycin.|Primary null hypothesis: After successful surgical drainage, placebo, Clindamycin, and TMP-SMX have equal rates of cure in the treatment of limited abscess at the TOC visit.||5.1|-5.4|1.0000
72375490|NCT00730028|144261365|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.4|||<|0.0001|TWO_SIDED|95.0|-19.2|-5.6||Adjustments for multiple comparisons were made using a Bonferroni correction.|Fisher Exact||The mean difference is determined by the cure rate of Placebo minus Clindamycin.|Primary null hypothesis: After successful surgical drainage, placebo, Clindamycin, and TMP-SMX have equal rates of cure in the treatment of limited abscess at the TOC visit.||-5.6|-19.2|<0.0001
72375491|NCT00730028|144261365|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.2||||0.0002|TWO_SIDED|95.0|-19.1|-5.4||Adjustments for multiple comparisons were made using a Bonferroni correction.|Fisher Exact||The mean difference is determined by the cure rate of Placebo minus TMP-SMX.|Primary null hypothesis: After successful surgical drainage, placebo, Clindamycin, and TMP-SMX have equal rates of cure in the treatment of limited abscess at the TOC visit.||-5.4|-19.1|0.0002
72375492|NCT00730028|144261368|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.6||||0.52|TWO_SIDED|95.0|-10.2|4.9||Adjustments for multiple comparisons were made using a Bonferroni correction.|Fisher Exact||The mean difference is determined by the cure rate of TMP-SMX minus Clindamycin.|Primary null hypothesis: Clindamycin and TMP-SMX have equal rates of cure in the treatment of cellulitis/larger abscess at the Test of Cure (TOC) visit.||4.9|-10.2|0.5200
72555868|NCT01604941|144643147|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0394|TWO_SIDED|||||The P-value is from analysis of paired t-test at post treatment timepoint vs. Baseline.|paired t-test|||Analysis of Week 12 for 50 mg/kg/d dosing||||0.0394
72375493|NCT00730028|144261368|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.3||||0.7324|TWO_SIDED|95.0|-8.4|5.7||Adjustments for multiple comparisons were made using a Bonferroni correction.|Fisher Exact||The mean difference is determined by the cure rate of TMP-SMX minus Clindamycin.|Primary null hypothesis: After successful surgical drainage, placebo, Clindamycin, and TMP-SMX have equal rates of cure in the treatment of limited abscess at the TOC visit.||5.7|-8.4|0.7324
72375494|NCT00730028|144261368|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.2||||0.0001|TWO_SIDED|95.0|-22.0|-6.4||Adjustments for multiple comparisons were made using a Bonferroni correction.|Fisher Exact||The mean difference is determined by the cure rate of Placebo minus Clindamycin.|Primary null hypothesis: After successful surgical drainage, placebo, Clindamycin, and TMP-SMX have equal rates of cure in the treatment of limited abscess at the TOC visit.||-6.4|-22.0|0.0001
72375495|NCT00730028|144261368|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.9||||0.0008|TWO_SIDED|95.0|-20.8|-5.0||Adjustments for multiple comparisons were made using a Bonferroni correction.|Fisher Exact||The mean difference is determined by the cure rate of Placebo minus TMP-SMX.|Primary null hypothesis: After successful surgical drainage, placebo, Clindamycin, and TMP-SMX have equal rates of cure in the treatment of limited abscess at the TOC visit.||-5.0|-20.8|0.0008
72555869|NCT01604941|144643147|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0004|TWO_SIDED|||||The P-value is from analysis of paired t-test at post treatment timepoint vs. Baseline.|paired t-test|||Analysis of Week 12 for all participants with BID dosing||||0.0004
72555870|NCT01604941|144643147|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0332|TWO_SIDED|||||The P-value is from analysis of paired t-test at post treatment timepoint vs. Baseline.|paired t-test|||Analysis of Week 24 for all participants with BID dosing||||0.0332
72555871|NCT01604941|144643148|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3202|TWO_SIDED|||||The P-value is from Paired t-test for log-transformed data at post treatment timepoint vs. Baseline.|paired t-test|||Analysis of Week 12 for 50 mg/kg/d dosing||||0.3202
72555872|NCT01604941|144643148|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4549|TWO_SIDED|||||The P-value is from Paired t-test for log-transformed data at post treatment timepoint vs. Baseline.|paired t-test|||Analysis of Week 12 for all participants with BID dosing||||0.4549
72555873|NCT01604941|144643148|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3291|TWO_SIDED|||||The P-value is from Paired t-test for log-transformed data at post treatment timepoint vs. Baseline.|paired t-test|||Analysis of Week 24 for all participants with BID dosing||||0.3291
72555874|NCT01604941|144643149|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6703|TWO_SIDED|||||The P-value is from Paired t-test for log-transformed data at post treatment timepoint vs. Baseline.|paired t-test|||Analysis of Week 8 for 50 mg/kg/d dosing||||0.6703
72555875|NCT01604941|144643149|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2618|TWO_SIDED|||||The P-value is from Paired t-test for log-transformed data at post treatment timepoint vs. Baseline.|paired t-test|||Analysis of Week 8 for all participants with BID dosing||||0.2618
72555876|NCT01604941|144643149|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7679|TWO_SIDED|||||The P-value is from Paired t-test for log-transformed data at post treatment timepoint vs. Baseline.|paired t-test|||Analysis of Week 16 for all participants with BID dosing||||0.7679
72555877|NCT01604941|144643150|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1683|TWO_SIDED|||||The P-value is from analysis of paired t-test at post treatment timepoint vs. Baseline.|paired t-test|||Analysis of Week 12 for 50 mg/kg/d dosing||||0.1683
72375496|NCT00730028|144261369|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9||||0.7707|TWO_SIDED|95.0|-7.1|5.3||Adjustments for multiple comparisons were not made for secondary efficacy outcome measures.|Fisher Exact||The mean difference is determined by the cure rate of TMP-SMX minus Clindamycin.|Null hypothesis: Clindamycin and TMP-SMX have equal rates of cure in the treatment of cellulitis/larger abscess.||5.3|-7.1|0.7707
72375497|NCT00730028|144261369|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.3||||0.2141|TWO_SIDED|95.0|-2.0|8.5||Adjustments for multiple comparisons were not made for secondary efficacy outcome measures.|Fisher Exact||The mean difference is determined by the cure rate of TMP-SMX minus Clindamycin.|Null hypothesis: After successful surgical drainage, placebo, Clindamycin, and TMP-SMX have equal rates of cure in the treatment of limited abscess.||8.5|-2.0|0.2141
72375498|NCT00730028|144261369|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.0||||0.0593|TWO_SIDED|95.0|-12.4|0.5||Adjustments for multiple comparisons were not made for secondary efficacy outcome measures.|Fisher Exact||The mean difference is determined by the cure rate of Placebo minus Clindamycin.|Null hypothesis: After successful surgical drainage, placebo, Clindamycin, and TMP-SMX have equal rates of cure in the treatment of limited abscess.||0.5|-12.4|0.0593
72395087|NCT00720434|144296638|SUPERIORITY_OR_OTHER||Difference in Proportions|-0.2|||||TWO_SIDED|95.0|-0.6191|0.2811||||||Week 72: The difference in proportions between treatment groups presented along with 95% CI, were based on exact method for small samples from the binomial distribution.||0.2811|-0.6191|
72395088|NCT00720434|144296638|SUPERIORITY_OR_OTHER||Difference in Proportions|0.0|||||TWO_SIDED|95.0|-0.507|0.507||||||Week 72: The difference in proportions between treatment groups presented along with 95% CI, were based on exact method for small samples from the binomial distribution.||0.5070|-0.5070|
72555878|NCT01604941|144643150|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0123|TWO_SIDED|||||The P-value is from analysis of paired t-test at post treatment timepoint vs. Baseline.|paired t-test|||Analysis of Week 12 for all participants with BID dosing||||0.0123
72555879|NCT01604941|144643150|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2334|TWO_SIDED|||||The P-value is from analysis of paired t-test at post treatment timepoint vs. Baseline.|paired t-test|||Analysis of Week 24 for all participants with BID dosing||||0.2334
72555880|NCT01640197|144643173|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||ANOVA|||||||>0.05
72555881|NCT01640197|144643174|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||ANOVA|||||||>0.05
72555882|NCT01640197|144643175|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||ANOVA|||||||>0.05
72555883|NCT01640197|144643176|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||ANOVA|||||||>0.05
72555884|NCT01640197|144643177|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||ANOVA|||||||>0.05
72555885|NCT01640197|144643178|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||ANOVA|||||||>0.05
72375499|NCT00730028|144261369|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.2||||0.0017|TWO_SIDED|95.0|-15.3|-3.1||Adjustments for multiple comparisons were not made for secondary efficacy outcome measures.|Fisher Exact||The mean difference is determined by the cure rate of Placebo minus TMP-SMX.|Null hypothesis: After successful surgical drainage, placebo, Clindamycin, and TMP-SMX have equal rates of cure in the treatment of limited abscess.||-3.1|-15.3|0.0017
72375500|NCT00730028|144261370|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.7||||0.1381|TWO_SIDED|95.0|-13.1|1.8||Adjustments for multiple comparisons were not made for secondary efficacy outcome measures.|Fisher Exact||The mean difference is determined by the cure rate of TMP-SMX minus Clindamycin.|Null hypothesis: Clindamycin and TMP-SMX have equal rates of cure in the treatment of cellulitis/larger abscess.||1.8|-13.1|0.1381
72375501|NCT00730028|144261370|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.9||||0.8302|TWO_SIDED|95.0|-6.4|8.2||Adjustments for multiple comparisons were not made for secondary efficacy outcome measures.|Fisher Exact||The mean difference is determined by the cure rate of TMP-SMX minus Clindamycin.|Null hypothesis: After successful surgical drainage, placebo, Clindamycin, and TMP-SMX have equal rates of cure in the treatment of limited abscess.||8.2|-6.4|0.8302
72375502|NCT00730028|144261370|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.6||||0.0838|TWO_SIDED|95.0|-14.3|1.1||Adjustments for multiple comparisons were not made for secondary efficacy outcome measures.|Fisher Exact||The mean difference is determined by the cure rate of Placebo minus Clindamycin.|Null hypothesis: After successful surgical drainage, placebo, Clindamycin, and TMP-SMX have equal rates of cure in the treatment of limited abscess.||1.1|-14.3|0.0838
72375503|NCT00730028|144261370|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.5||||0.0507|TWO_SIDED|95.0|-15.2|0.2||Adjustments for multiple comparisons were not made for secondary efficacy outcome measures.|Fisher Exact||The mean difference is determined by the cure rate of Placebo minus TMP-SMX.|Null hypothesis: After successful surgical drainage, placebo, Clindamycin, and TMP-SMX have equal rates of cure in the treatment of limited abscess.||0.2|-15.2|0.0507
72375504|NCT00730028|144261371|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.7||||0.1505|TWO_SIDED|95.0|-13.3|1.9||Adjustments for multiple comparisons were not made for secondary efficacy outcome measures.|Fisher Exact||The mean difference is determined by the cure rate of TMP-SMX minus Clindamycin.|Null hypothesis: Clindamycin and TMP-SMX have equal rates of cure in the treatment of cellulitis/larger abscess.||1.9|-13.3|0.1505
72375505|NCT00730028|144261371|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.4||||0.1666|TWO_SIDED|95.0|-10.9|2.2||Adjustments for multiple comparisons were not made for secondary efficacy outcome measures.|Fisher Exact||The mean difference is determined by the cure rate of TMP-SMX minus Clindamycin.|Null hypothesis: After successful surgical drainage, placebo, Clindamycin, and TMP-SMX have equal rates of cure in the treatment of limited abscess.||2.2|-10.9|0.1666
72375506|NCT00730028|144261371|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.5|||<|0.0001|TWO_SIDED|95.0|-23.0|-8.0||Adjustments for multiple comparisons were not made for secondary efficacy outcome measures.|Fisher Exact||The mean difference is determined by the cure rate of Placebo minus Clindamycin.|Null hypothesis: After successful surgical drainage, placebo, Clindamycin, and TMP-SMX have equal rates of cure in the treatment of limited abscess.||-8.0|-23.0|<0.0001
72375507|NCT00730028|144261371|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.1||||0.0046|TWO_SIDED|95.0|-19.0|-3.2||Adjustments for multiple comparisons were not made for secondary efficacy outcome measures.|Fisher Exact||The mean difference is determined by the cure rate of Placebo minus TMP-SMX.|Null hypothesis: After successful surgical drainage, placebo, Clindamycin, and TMP-SMX have equal rates of cure in the treatment of limited abscess.||-3.2|-19.0|0.0046
72555886|NCT01640197|144643179|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||ANOVA|||||||>0.05
72555887|NCT01075282|144643207|NON_INFERIORITY_OR_EQUIVALENCE|Family-wise Type I error rate was controlled by applying gatekeeping strategy.|LS Mean Difference|-0.45|||<|0.001|TWO_SIDED|95.0|-0.6|-0.29||P-value is adjusted for multiplicity, based on tree-gatekeeping strategy. To determine significance, p-value is compared to the family-wise 1-sided Type I error of 0.025. The confidence interval is not adjusted for multiplicity.|ANCOVA|||The study was designed with 90% power to detect non-inferiority of LY2189265 1.5 mg vs insulin glargine on HbA1c change from baseline at the 52-week primary endpoint with a margin of 0.4%, a standard deviation of 1.3%, and a 1-sided alpha of 0.025 assuming no true difference between treatments. This corresponds to 223 participants per arm, with an assumed drop-out rate of 20%.||-0.29|-0.60|<0.001
72375508|NCT00730028|144261372|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.4||||0.1815|TWO_SIDED|95.0|-13.6|2.8||Adjustments for multiple comparisons were not made for secondary efficacy outcome measures.|Fisher Exact||The mean difference is determined by the cure rate of TMP-SMX minus Clindamycin.|Null hypothesis: Clindamycin and TMP-SMX have equal rates of cure in the treatment of cellulitis/larger abscess.||2.8|-13.6|0.1815
72375509|NCT00730028|144261372|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.6||||0.1552|TWO_SIDED|95.0|-13.2|2.1||Adjustments for multiple comparisons were not made for secondary efficacy outcome measures.|Fisher Exact||The mean difference is determined by the cure rate of TMP-SMX minus Clindamycin.|Null hypothesis: After successful surgical drainage, placebo, Clindamycin, and TMP-SMX have equal rates of cure in the treatment of limited abscess.||2.1|-13.2|0.1552
72375510|NCT00730028|144261372|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.9|||<|0.0001|TWO_SIDED|95.0|-24.0|-7.8||Adjustments for multiple comparisons were not made for secondary efficacy outcome measures.|Fisher Exact||The mean difference is determined by the cure rate of Placebo minus Clindamycin.|Null hypothesis: After successful surgical drainage, placebo, Clindamycin, and TMP-SMX have equal rates of cure in the treatment of limited abscess.||-7.8|-24.0|<0.0001
72375511|NCT00730028|144261372|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.4||||0.0145|TWO_SIDED|95.0|-18.7|-2.0||Adjustments for multiple comparisons were not made for secondary efficacy outcome measures.|Fisher Exact||The mean difference is determined by the cure rate of Placebo minus TMP-SMX.|Null hypothesis: After successful surgical drainage, placebo, Clindamycin, and TMP-SMX have equal rates of cure in the treatment of limited abscess.||-2.0|-18.7|0.0145
72375512|NCT00528970|144261375|OTHER||Mean Difference (Final Values)|2.0||||0.944||||||Threshold for significance at 0.05 level.|Log Rank|||Analysis was performed using log-rank test stratified by surgery type and region for comparisons of survival distributions for active MOA versus Placebo group.||||0.944
72375513|NCT00528970|144261375|OTHER||Mean Difference (Final Values)|9.1||||0.208||||||Threshold for significance at 0.05 level.|Log Rank|||Analysis was performed using log-rank test stratified by surgery type and region for comparisons of survival distributions for active MOA versus Placebo group.||||0.208
72375514|NCT03860935|144261379|SUPERIORITY||||||<|0.0001|||||||Finkelstein-Schoenfeld Method|||||||<0.0001
72375515|NCT03860935|144261380|SUPERIORITY||Least Squares Mean Difference|39.64|STANDARD_ERROR_OF_MEAN|9.477|<|0.0001|TWO_SIDED|96.0|20.18|59.1|||Mixed Models Analysis|||LS means are from a MMRM model with treatment group, visit, randomization stratification factors of genotype, NT-proBNP level and eGFR level (as recorded in IXRS) and treatment group-by-visit interaction as factors, and baseline value as covariate. Missing measurements due to early discontinuation of study treatment and due to death were imputed using the Jump to Reference (J2R) method and sampling with replacement from the worst 5% of observed values, respectively, as specified in study SAP.||59.10|20.18|<0.0001
72375516|NCT03860935|144261381|SUPERIORITY||Least Squares Mean Difference|9.94|STANDARD_ERROR_OF_MEAN|2.024|<|0.0001|TWO_SIDED|96.0|5.79|14.1|||Mixed Models Analysis|||LS means are from a MMRM model with treatment group, visit, randomization stratification factors of genotype, NT-proBNP level and eGFR level (as recorded in IXRS) and treatment group-by-visit interaction as factors, and baseline value as covariate. Missing measurements due to early discontinuation of study treatment and due to death were imputed using the Jump to Reference (J2R) method and sampling with replacement from the worst 5% of observed values, respectively, as specified in study SAP.||14.10|5.79|<0.0001
72375517|NCT03860935|144261382|SUPERIORITY||Least Squares Mean Difference|7.1|STANDARD_ERROR_OF_MEAN|0.665|<|0.0001|TWO_SIDED|96.0|5.73|8.46|||Mixed Models Analysis|||LS means are from a MMRM model with treatment group, visit, randomization stratification factors of genotype, NT-proBNP level and eGFR level (as recorded in IXRS) and treatment group-by-visit interaction as factors, and baseline value as covariate. Missing measurements due to early discontinuation of study treatment and due to death were imputed using the Jump to Reference (J2R) method and sampling with replacement from the worst 5% of observed values, respectively, as specified in study SAP.||8.46|5.73|<0.0001
72375518|NCT03860935|144261383|SUPERIORITY||Relative Risk Reduction (%)|25.0||||0.0569|TWO_SIDED|||||Cochran-Mantel-Haenszel test is stratified by randomization stratification factors of genotype, NT-proBNP level and eGFR level as recorded in IXRS.|Cochran-Mantel-Haenszel|||||||0.0569
72375519|NCT03086967|144261384|SUPERIORITY|||||||0.8|||||||t-test, 2 sided|||||||0.8
72375520|NCT03086967|144261385|SUPERIORITY|||||||0.133|||||||t-test, 2 sided|||||||0.133
72375521|NCT03086967|144261386|SUPERIORITY|||||||0.58|||||||t-test, 2 sided|||||||0.58
72375522|NCT03086967|144261387|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
72375523|NCT03086967|144261388|SUPERIORITY|||||||0.8|||||||Chi-squared|||||||0.8
72375524|NCT03086967|144261389|SUPERIORITY|||||||0.95|||||||Chi-squared|||||||0.95
72375525|NCT03086967|144261390|SUPERIORITY|||||||0.98|||||||Chi-squared|||||||0.98
72375526|NCT03086967|144261391|SUPERIORITY|||||||0.95|||||||t-test, 2 sided|||||||0.95
72375527|NCT03086967|144261392|SUPERIORITY|||||||0.1|||||||t-test, 2 sided|||||||0.1
72375528|NCT03086967|144261393|SUPERIORITY|||||||0.0003|||||||t-test, 2 sided|||||||0.0003
72375529|NCT03086967|144261394|SUPERIORITY|||||||0.48|||||||t-test, 2 sided|||||||0.48
72375530|NCT02660138|144261450|SUPERIORITY|If both p-values for the 2 primary tests (the test of Dysport® 800 U vs. placebo and the test of Dysport® 600 U vs. placebo) were lower than 0.05, both were declared statistically significant. If 1 of the primary tests had a p-value greater than or equal to 0.05, then the other test was declared statistically significant if its p-value was lower than 0.025.|LS Mean Difference|-10.83||||0.0001|TWO_SIDED|95.0|-16.36|-5.31|||MMRM|||Treatment group, visit (Week 2, Week 6 and Week 12), treatment-by-visit interaction, recorded stratification factors (aetiology of NDO \[SCI or MS\], prior intradetrusor \[Botulinum toxin \[BTX\]-naïve or BTX-non-naïve\]) and study baseline value (weekly number of UI episodes) as fixed effect variables, and subject as a random effect.||-5.31|-16.36|0.0001
72375531|NCT02660138|144261450|SUPERIORITY|If both p-values for the 2 primary tests (the test of Dysport® 800 U vs. placebo and the test of Dysport® 600 U vs. placebo) were lower than 0.05, both were declared statistically significant. If 1 of the primary tests had a p-value greater than or equal to 0.05, then the other test was declared statistically significant if its p-value was lower than 0.025.|LS Mean Difference|-12.19|||<|0.0001|TWO_SIDED|95.0|-17.65|-6.73|||MMRM|||Treatment group, visit (Week 2, Week 6 and Week 12), treatment-by-visit interaction, recorded stratification factors (aetiology of NDO \[SCI or MS\], prior intradetrusor \[BTX-naïve or BTX-non-naïve\]) and study baseline value (weekly number of UI episodes) as fixed effect variables, and subject as a random effect.||-6.73|-17.65|<0.0001
72375532|NCT02660138|144261451|SUPERIORITY|This secondary endpoint was included in the hierarchical analysis and was tested for both doses at the 0.05 level using a hierarchical methodology.|LS Mean Difference|160.9|||<|0.0001|TWO_SIDED|95.0|109.9|211.9|||ANCOVA|||Treatment group, recorded stratification factors (aetiology of NDO \[SCI or MS\], prior intradetrusor \[BTX-naïve or BTX-non-naïve\]) and baseline value of MCC as covariates.||211.9|109.9|<0.0001
72375533|NCT02660138|144261451|SUPERIORITY|This secondary endpoint was included in the hierarchical analysis and was tested for both doses at the 0.05 level using a hierarchical methodology.|LS Mean Difference|189.2|||<|0.0001|TWO_SIDED|95.0|140.1|238.2|||ANCOVA|||Treatment group, recorded stratification factors (aetiology of NDO \[SCI or MS\], prior intradetrusor \[BTX-naïve or BTX-non-naïve\]) and baseline value of MCC as covariates.||238.2|140.1|<0.0001
72375534|NCT02660138|144261452|SUPERIORITY|This secondary endpoint was included in the hierarchical analysis and was tested for both doses at the 0.05 level using a hierarchical methodology.|LS Mean Difference|-24.3|||<|0.0001|TWO_SIDED|95.0|-32.3|-16.4|||ANCOVA|||Treatment group, recorded stratification factors (aetiology of NDO \[SCI or MS\], prior intradetrusor \[BTX-naïve or BTX-non-naïve\]) and baseline value of MDP as covariates.||-16.4|-32.3|<0.0001
72375535|NCT02660138|144261452|SUPERIORITY|This secondary endpoint was included in the hierarchical analysis and was tested for both doses at the 0.05 level using a hierarchical methodology.|LS Mean Difference|-28.6|||<|0.0001|TWO_SIDED|95.0|-36.2|-21.1|||ANCOVA|||Treatment group, recorded stratification factors (aetiology of NDO \[SCI or MS\], prior intradetrusor \[BTX-naïve or BTX-non-naïve\]) and baseline value of MDP as covariates.||-21.1|-36.2|<0.0001
72555888|NCT01075282|144643207|NON_INFERIORITY_OR_EQUIVALENCE|Family-wise Type I error rate was controlled by applying gatekeeping strategy.|LS Mean Difference|-0.13|||<|0.001|TWO_SIDED|95.0|-0.29|0.02||P-value is adjusted for multiplicity, based on tree-gatekeeping strategy. To determine significance, p-value is compared to the family-wise 1-sided Type I error of 0.025. The confidence interval is not adjusted for multiplicity.|ANCOVA|||Non-inferiority analysis.||0.02|-0.29|<0.001
72375536|NCT02660138|144261453|SUPERIORITY|This secondary endpoint was included in the hierarchical analysis and was tested for both doses at the 0.05 level using a hierarchical methodology.|LS Mean Difference|155.5|||<|0.0001|TWO_SIDED|95.0|100.5|210.4|||ANCOVA|||Treatment group, recorded stratification factors (aetiology of NDO \[SCI or MS\], prior intradetrusor \[BTX-naïve or BTX-non-naïve\]) and baseline value of Vol@1stIDC as covariates.||210.4|100.5|<0.0001
72375537|NCT02660138|144261453|SUPERIORITY|This secondary endpoint was included in the hierarchical analysis and was tested for both doses at the 0.05 level using a hierarchical methodology.|LS Mean Difference|181.8|||<|0.0001|TWO_SIDED|95.0|129.2|234.3|||ANCOVA|||Treatment group, recorded stratification factors (aetiology of NDO \[SCI or MS\], prior intradetrusor \[BTX-naïve or BTX-non-naïve\]) and baseline value of Vol@1stIDC as covariates.||234.3|129.2|<0.0001
72375538|NCT02660138|144261454|SUPERIORITY|This secondary endpoint was included in the hierarchical analysis and was tested for both doses at the 0.05 level using a hierarchical methodology.|Odds Ratio (OR)|9.83||||0.0006|TWO_SIDED|95.0|2.72|35.6|||Generalised linear mixed model (GLMM)|||Treatment group, recorded stratification factors, visit (Week 2, Week 6 and Week 12), treatment-by-visit interaction, study baseline-by-visit interaction and study baseline weekly number of UI episodes as fixed effect.||35.60|2.72|0.0006
72375539|NCT02660138|144261454|SUPERIORITY|This secondary endpoint was included in the hierarchical analysis and was tested for both doses at the 0.05 level using a hierarchical methodology.|Odds Ratio (OR)|10.99||||0.0003|TWO_SIDED|95.0|3.05|39.61|||GLMM|||Treatment group, recorded stratification factors, visit (Week 2, Week 6 and Week 12), treatment-by-visit interaction, study baseline-by-visit interaction and study baseline weekly number of UI episodes as fixed effect.||39.61|3.05|0.0003
72375540|NCT02660138|144261455|SUPERIORITY|This secondary endpoint was included in the hierarchical analysis and was tested for both doses at the 0.05 level using a hierarchical methodology.|Odds Ratio (OR)|5.73||||0.001|TWO_SIDED|95.0|2.02|16.24|||Regression, Logistic|||Treatment group, and recorded stratification factors (aetiology of NDO, previous BTX-A usage) and study baseline (prior intradetrusor BTX-A usage for UI) as explanatory variables.||16.24|2.02|0.0010
72375541|NCT02660138|144261455|SUPERIORITY|This secondary endpoint was included in the hierarchical analysis and was tested for both doses at the 0.05 level using a hierarchical methodology.|Odds Ratio (OR)|16.08|||<|0.0001|TWO_SIDED|95.0|5.82|44.43|||Regression, Logistic|||Treatment group, and recorded stratification factors (aetiology of NDO, previous BTX-A usage) and study baseline (prior intradetrusor BTX-A usage for UI) as explanatory variables.||44.43|5.82|<0.0001
72375542|NCT02660138|144261456|SUPERIORITY|This secondary endpoint was included in the hierarchical analysis and was tested for both doses at the 0.05 level using a hierarchical methodology.|LS Mean Difference|13.3||||0.0003|TWO_SIDED|95.0|6.22|20.37|||MMRM|||Treatment group, visit (Week 6 and Week 12), treatment-by-visit interaction, recorded stratification factors (aetiology of NDO \[SCI or MS\], prior intradetrusor \[BTX-naïve or BTX-non-naïve\]) and study baseline value (I-QoL summary total score) as fixed variables, and subject as a random effect.||20.37|6.22|0.0003
72375543|NCT02660138|144261456|SUPERIORITY|The secondary endpoint was included in the hierarchical analysis and was tested for both doses at the 0.05 level using a hierarchical methodology.|LS Mean Difference|17.25|||<|0.0001|TWO_SIDED|95.0|10.36|24.15|||MMRM|||Treatment group, visit (Week 6 and Week 12), treatment-by-visit interaction, recorded stratification factors (aetiology of NDO \[SCI or MS\], prior intradetrusor \[BTX-naïve or BTX-non-naïve\]) and study baseline value (I-QoL summary total score) as fixed variables, and subject as a random effect.||24.15|10.36|<0.0001
72375544|NCT02660138|144261457|SUPERIORITY|Treatment group, recorded stratification factors, visit (Week 2, Week 6 and Week 12), treatment-by-visit interaction, study baseline-by-visit interaction and study baseline weekly number of UI episodes as fixed effect.|Odds Ratio (OR)|4.0||||0.0007|TWO_SIDED|95.0|1.8|8.86||This secondary endpoint was not included within the hierarchical testing procedure and was analysed for exploratory purposes only to compare each Dysport® dose to placebo at a 0.05 type one error rate.|GLMM|||Treatment comparison at ≥30% Improvement Level: Dysport® 600 U versus Placebo.||8.86|1.80|0.0007
72375545|NCT02660138|144261457|SUPERIORITY|Treatment group, recorded stratification factors, visit (Week 2, Week 6 and Week 12), treatment-by-visit interaction, study baseline-by-visit interaction and study baseline weekly number of UI episodes as fixed effect.|Odds Ratio (OR)|3.63||||0.0012|TWO_SIDED|95.0|1.68|7.86||This secondary endpoint was not included within the hierarchical testing procedure and was analysed for exploratory purposes only to compare each Dysport® dose to placebo at a 0.05 type one error rate.|GLMM|||Treatment comparison at ≥30% Improvement Level: Dysport® 800 U versus Placebo||7.86|1.68|0.0012
72375546|NCT02660138|144261457|SUPERIORITY|Treatment group, recorded stratification factors, visit (Week 2, Week 6 and Week 12), treatment-by-visit interaction, study baseline-by-visit interaction and study baseline weekly number of UI episodes as fixed effect.|Odds Ratio (OR)|8.03|||<|0.0001|TWO_SIDED|95.0|3.56|18.09||This secondary endpoint was not included within the hierarchical testing procedure and was analysed for exploratory purposes only to compare each Dysport® dose to placebo at a 0.05 type one error rate.|GLMM|||Treatment comparison at ≥50% Improvement Level: Dysport® 600 U versus Placebo.||18.09|3.56|<0.0001
72375547|NCT02660138|144261457|SUPERIORITY|Treatment group, recorded stratification factors, visit (Week 2, Week 6 and Week 12), treatment-by-visit interaction, study baseline-by-visit interaction and study baseline weekly number of UI episodes as fixed effect.|Odds Ratio (OR)|8.22|||<|0.0001|TWO_SIDED|95.0|3.66|18.47||This secondary endpoint was not included within the hierarchical testing procedure and was analysed for exploratory purposes only to compare each Dysport® dose to placebo at a 0.05 type one error rate.|GLMM|||Treatment comparison at ≥50% Improvement Level: Dysport® 800 U versus Placebo||18.47|3.66|<0.0001
72555889|NCT01075282|144643207|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.45|||<|0.001|TWO_SIDED|95.0|-0.6|-0.29||P-value is adjusted for multiplicity, based on tree-gatekeeping strategy. To determine significance, p-value is compared to the family-wise 1-sided Type I error of 0.025. The confidence interval is not adjusted for multiplicity.|ANCOVA|||Superiority analysis.||-0.29|-0.60|<0.001
72375548|NCT02660138|144261457|OTHER|Treatment group, recorded stratification factors, visit (Week 2, Week 6 and Week 12), treatment-by-visit interaction, study baseline-by-visit interaction and study baseline weekly number of UI episodes as fixed effect.|Odds Ratio (OR)|10.7|||<|0.0001|TWO_SIDED|95.0|4.59|24.95||This secondary endpoint was not included within the hierarchical testing procedure and was analysed for exploratory purposes only to compare each Dysport® dose to placebo at a 0.05 type one error rate.|GLMM|||Treatment comparison at ≥75% Improvement Level: Dysport® 600 U versus Placebo.||24.95|4.59|<0.0001
72375549|NCT02660138|144261457|SUPERIORITY|Treatment group, recorded stratification factors, visit (Week 2, Week 6 and Week 12), treatment-by-visit interaction, study baseline-by-visit interaction and study baseline weekly number of UI episodes as fixed effect.|Odds Ratio (OR)|12.63|||<|0.0001|TWO_SIDED|95.0|5.4|29.56||This secondary endpoint was not included within the hierarchical testing procedure and was analysed for exploratory purposes only to compare each Dysport® dose to placebo at a 0.05 type one error rate.|GLMM|||Treatment comparison at ≥75% Improvement Level: Dysport® 800 U versus Placebo.||29.56|5.40|<0.0001
72375550|NCT02660138|144261458|SUPERIORITY|This secondary endpoint was not included within the hierarchical testing procedure and was analysed for exploratory purposes only to compare each Dysport® dose to placebo at a 0.05 type one error rate.|LS Mean Difference|84.81|||<|0.0001|TWO_SIDED|95.0|43.73|125.89|||MMRM|||Treatment group, visit (Week 2, Week 6 and Week 12), treatment-by-visit interaction, recorded stratification factors (aetiology of NDO \[SCI or MS\], prior intradetrusor \[BTX-naïve or BTX-non-naïve\]) and study baseline value (total volume per void) as fixed effect variables, and subject as a random effect.||125.89|43.73|<0.0001
72375551|NCT02660138|144261458|SUPERIORITY|This secondary endpoint was not included within the hierarchical testing procedure and was analysed for exploratory purposes only to compare each Dysport® dose to placebo at a 0.05 type one error rate.|LS Mean Difference|110.57|||<|0.0001|TWO_SIDED|95.0|70.17|150.98|||MMRM|||Treatment group, visit (Week 2, Week 6 and Week 12), treatment-by-visit interaction, recorded stratification factors (aetiology of NDO \[SCI or MS\], prior intradetrusor \[BTX-naïve or BTX-non-naïve\]) and study baseline value (total volume per void) as fixed effect variables, and subject as a random effect.||150.98|70.17|<0.0001
72375552|NCT04876690|144261471|SUPERIORITY||||||=|0.1217|||||||t-test for Independent Samples|||PCS-12: Sex||||=0.1217
72375553|NCT04876690|144261471|SUPERIORITY||||||=|0.8241|||||||ANOVA|ANOVA=Analysis of variance||PCS-12: Employment Status||||=0.8241
72375554|NCT04876690|144261471|SUPERIORITY||||||=|0.3471|||||||ANOVA|||PCS-12: Smoking Status||||=0.3471
72375555|NCT04876690|144261471|SUPERIORITY||||||=|0.9951|||||||ANOVA|||PCS-12: Age at Onset||||=0.9951
72375556|NCT04876690|144261471|SUPERIORITY||||||=|0.0631|||||||ANOVA|||PCS-12: Disease Location||||=0.0631
72375557|NCT04876690|144261471|SUPERIORITY||||||=|0.7473|||||||ANOVA|||PCS-12: Disease Behavior||||=0.7473
72375558|NCT04876690|144261471|SUPERIORITY||||||=|0.4422|||||||t-test for Independent Samples|||PCS-12: Presence of any Extraintestinal Manifestation of CD||||=0.4422
72375559|NCT04876690|144261471|SUPERIORITY||||||=|0.1796|||||||t-test for Independent Samples|||PCS-12: Fistula With High Intersphincteric Type||||=0.1796
72375560|NCT04876690|144261471|SUPERIORITY||||||=|0.3535|||||||t-test for Independent Samples|||PCS-12: Fistula With High Transsphincteric Type||||=0.3535
72375561|NCT04876690|144261471|SUPERIORITY||||||=|0.1508|||||||t-test for Independent Samples|||PCS-12: Fistula With Suprasphincteric Type||||=0.1508
72375562|NCT04876690|144261471|SUPERIORITY||||||=|0.2671|||||||t-test for Independent Samples|||PCS-12: Fistula with Extrasphincteric Type||||=0.2671
72375563|NCT04876690|144261471|SUPERIORITY||||||=|0.0594|||||||t-test for Independent Samples|||PCS-12: Fistula With Low Intersphincteric Type||||=0.0594
72375564|NCT04876690|144261471|SUPERIORITY||||||=|0.5484|||||||t-test for Independent Samples|||PCS-12: Fistula With Low Transsphincteric Type||||=0.5484
72375565|NCT04876690|144261471|SUPERIORITY||||||=|0.5387|||||||t-test for Independent Samples|||PCS-12: Fistula With Midline Position||||=0.5387
72375566|NCT04876690|144261471|SUPERIORITY||||||=|0.527|||||||t-test for Independent Samples|||PCS-12: Fistula With Lateral Position||||=0.5270
72375567|NCT04876690|144261471|SUPERIORITY||||||=|0.3863|||||||t-test for Independent Samples|||PCS-12: Fistula With Seton||||=0.3863
72375568|NCT04876690|144261471|SUPERIORITY||||||=|0.4206|||||||ANOVA|||PCS-12: HBI Categories (Remission, Mild and Moderate Activity)||||=0.4206
72375569|NCT04876690|144261471|SUPERIORITY||||||=|0.0538|||||||t-test for Independent Samples|||PCS-12: Surgery-naïve||||=0.0538
72375570|NCT04876690|144261471|SUPERIORITY||||||=|0.9572|||||||t-test for Independent Samples|||PCS-12: Surgery - Fistulotomy||||=0.9572
72375571|NCT04876690|144261471|SUPERIORITY||||||=|0.4742|||||||t-test for Independent Samples|||PCS-12: Surgery - Loose Seton||||=0.4742
72375572|NCT04876690|144261471|SUPERIORITY||||||=|0.5735|||||||t-test for Independent Samples|||PCS-12: Surgery - Other||||=0.5735
72375573|NCT04876690|144261471|SUPERIORITY||||||=|0.376|||||||t-test for Independent Samples|||PCS-12: Presence of Perianal Abscess||||=0.3760
72375574|NCT04876690|144261472|SUPERIORITY||||||=|0.4814|||||||t-test for Independent Samples|||MCS-12: Sex||||=0.4814
72375575|NCT04876690|144261472|SUPERIORITY||||||=|0.3136|||||||Kruskal-Wallis|||MCS-12: Employment Status||||=0.3136
72375576|NCT04876690|144261472|SUPERIORITY||||||=|0.5808|||||||ANOVA|||MCS-12: Smoking Status||||=0.5808
72375577|NCT04876690|144261472|SUPERIORITY||||||=|0.2965|||||||ANOVA|||MCS-12: Age at Onset||||=0.2965
72375578|NCT04876690|144261472|SUPERIORITY||||||=|0.2874|||||||ANOVA|||MCS-12: Disease Location||||=0.2874
72375579|NCT04876690|144261472|SUPERIORITY||||||=|0.4269|||||||ANOVA|||MCS-12: Disease Behavior||||=0.4269
72375580|NCT04876690|144261472|SUPERIORITY||||||=|0.8931|||||||t-test for Independent Samples|||MCS-12: Presence of any Extraintestinal Manifestation of CD||||=0.8931
72375581|NCT04876690|144261472|SUPERIORITY||||||=|0.9384|||||||t-test for Independent Samples|||MCS-12: Fistula With High Intersphincteric Type||||=0.9384
72375582|NCT04876690|144261472|SUPERIORITY||||||=|0.8286|||||||Mann-Whitney|||MCS-12: Fistula With High Transsphincteric Type||||=0.8286
72375583|NCT04876690|144261472|SUPERIORITY||||||=|0.1919|||||||t-test for Independent Samples|||MCS-12: Fistula With Suprasphincteric Type||||=0.1919
72375584|NCT04876690|144261472|SUPERIORITY||||||=|0.6452|||||||t-test for Independent Samples|||MCS-12: Fistula with Extrasphincteric Type||||=0.6452
72375585|NCT04876690|144261472|SUPERIORITY||||||=|0.7218|||||||t-test for Independent Samples|||MCS-12: Fistula With Low Intersphincteric Type||||=0.7218
72375586|NCT04876690|144261472|SUPERIORITY||||||=|0.9738|||||||t-test for Independent Samples|||MCS-12: Fistula With Low Transsphincteric Type||||=0.9738
72375587|NCT04876690|144261472|SUPERIORITY||||||=|0.2419|||||||t-test for Independent Samples|||MCS-12: Fistula With Midline Position||||=0.2419
72375588|NCT04876690|144261472|SUPERIORITY||||||=|0.5524|||||||t-test for Independent Samples|||MCS-12: Fistula With Lateral Position||||=0.5524
72375589|NCT04876690|144261472|SUPERIORITY||||||=|0.4443|||||||t-test for Independent Samples|||MCS-12: Fistula With Seton||||=0.4443
72375590|NCT04876690|144261472|SUPERIORITY||||||=|0.4106|||||||ANOVA|||MCS-12: HBI Categories (Remission, Mild and Moderate Activity)||||=0.4106
72375591|NCT04876690|144261472|SUPERIORITY||||||=|0.7795|||||||t-test for Independent Samples|||MCS-12: Surgery-naïve||||=0.7795
72375592|NCT04876690|144261472|SUPERIORITY||||||=|0.2964|||||||t-test for Independent Samples|||MCS-12: Surgery - Fistulotomy||||=0.2964
72375593|NCT04876690|144261472|SUPERIORITY||||||=|0.3287|||||||t-test for Independent Samples|||MCS-12: Surgery - Loose Seton||||=0.3287
72375594|NCT04876690|144261472|SUPERIORITY||||||=|0.0091|||||||t-test for Independent Samples|||MCS-12: Surgery - Other||||=0.0091
72375595|NCT04876690|144261472|SUPERIORITY||||||=|0.3889|||||||t-test for Independent Samples|||MCS-12: Presence of Perianal Abscess||||=0.3889
72375596|NCT04876690|144261473|SUPERIORITY||||||=|0.8001|||||||Pearson Correlation Coefficient|||PCS- 12: Age||||=0.8001
72375597|NCT04876690|144261473|SUPERIORITY||||||=|0.4532|||||||Pearson Correlation Coefficient|||PCS- 12: BMI||||=0.4532
72375598|NCT04876690|144261473|SUPERIORITY||||||=|0.9597|||||||Spearman Correlation Coefficient|||PCS- 12: Time Between CD Diagnosis Date and Date of Study Visit||||=0.9597
72375599|NCT04876690|144261473|SUPERIORITY||||||=|0.3304|||||||Spearman Correlation Coefficient|||PCS- 12: Total Number of CPFs per Participant||||=0.3304
72375600|NCT04876690|144261473|SUPERIORITY||||||=|0.6333|||||||Pearson Correlation Coefficient|||PCS- 12: Time Since Seton Replacement||||=0.6333
72375601|NCT04876690|144261473|SUPERIORITY||||||=|0.8003|||||||Spearman Correlation Coefficient|||PCS- 12: Time Between First CPF Diagnosis Date and Date of Study Visit||||=0.8003
72375602|NCT04876690|144261473|SUPERIORITY||||||=|0.0032|||||||Pearson Correlation Coefficient|||PCS- 12: PDAI Score||||=0.0032
72555890|NCT01075282|144643207|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.13||||0.05|TWO_SIDED|95.0|-0.29|0.02||P-value is adjusted for multiplicity, based on tree-gatekeeping strategy. To determine significance, p-value is compared to the family-wise 1-sided Type I error of 0.025. The confidence interval is not adjusted for multiplicity.|ANCOVA|||Superiority analysis.||0.02|-0.29|0.05
72375603|NCT04876690|144261473|SUPERIORITY||||||=|0.0923|||||||Spearman Correlation Coefficient|||PCS- 12: Number of Internal Fistula Openings per Participant||||=0.0923
72375604|NCT04876690|144261473|SUPERIORITY||||||=|0.0994|||||||Spearman Correlation Coefficient|||PCS- 12: Number of External Fistula Openings per Participant||||=0.0994
72375605|NCT04876690|144261473|SUPERIORITY||||||=|0.0444|||||||Pearson Correlation Coefficient|||PCS- 12: SIBDQ Score||||=0.0444
72375606|NCT04876690|144261473|SUPERIORITY||||||=|0.086|||||||Pearson Correlation Coefficient|||PCS- 12: SQoL-M Score||||=0.0860
72375607|NCT04876690|144261473|SUPERIORITY||||||=|0.9415|||||||Pearson Correlation Coefficient|||PCS- 12: SQoL-F Score||||=0.9415
72375608|NCT04876690|144261473|SUPERIORITY||||||=|0.3709|||||||Pearson Correlation Coefficient|||PCS- 12: Wexner Score||||=0.3709
72375609|NCT04876690|144261474|SUPERIORITY||||||=|0.0674|||||||Pearson Correlation Coefficient|||MCS- 12: Age||||=0.0674
72375610|NCT04876690|144261474|SUPERIORITY||||||=|0.9392|||||||Pearson Correlation Coefficient|||MCS- 12: BMI||||=0.9392
72375611|NCT04876690|144261474|SUPERIORITY||||||=|0.6387|||||||Spearman Correlation Coefficient|||MCS- 12: Time Between CD Diagnosis Date and Date of Study Visit||||=0.6387
72375612|NCT04876690|144261474|SUPERIORITY||||||=|0.7846|||||||Spearman Correlation Coefficient|||MCS- 12: Total Number of CPFs per Participant||||=0.7846
72375613|NCT04876690|144261474|SUPERIORITY||||||=|0.3972|||||||Pearson Correlation Coefficient|||MCS- 12: Time Since Seton Placement||||=0.3972
72375614|NCT04876690|144261474|SUPERIORITY||||||=|0.9496|||||||Spearman Correlation Coefficient|||MCS- 12: Time Between First CPF Diagnosis Date and Date of Study Visit||||=0.9496
72375615|NCT04876690|144261474|SUPERIORITY||||||=|0.813|||||||Pearson Correlation Coefficient|||MCS- 12: PDAI Score||||=0.8130
72375616|NCT04876690|144261474|SUPERIORITY||||||=|0.4588|||||||Spearman Correlation Coefficient|||MCS- 12: Number of Internal Fistula Openings per Participant||||=0.4588
72375617|NCT04876690|144261474|SUPERIORITY||||||=|0.8663|||||||Spearman Correlation Coefficient|||MCS- 12: Number of External Fistula Openings per Participant||||=0.8663
72375618|NCT04876690|144261474|SUPERIORITY||||||=|0.1349|||||||Pearson Correlation Coefficient|||MCS- 12: SIBDQ Score||||=0.1349
72375619|NCT04876690|144261474|SUPERIORITY||||||=|0.5647|||||||Pearson Correlation Coefficient|||MCS- 12: SQoL-M Score||||=0.5647
72375620|NCT04876690|144261474|SUPERIORITY||||||=|0.9509|||||||Pearson Correlation Coefficient|||MCS- 12: SQoL-F Score||||=0.9509
72375621|NCT04876690|144261474|SUPERIORITY||||||=|0.5328|||||||Pearson Correlation Coefficient|||MCS- 12: Wexner Score||||=0.5328
72375622|NCT00308581|144261476|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.1||||0.696||95.0|0.7|1.7||Logistic regression model including terms for treatment arm and geographical region (North America versus Europe).|Regression, Logistic||Direction of comparison is Q4W regimen (active 1) versus Q2W regimen (active 2).|With a sample size of 165 patients per treatment arm, assuming a percentage of responders of 45% with the Q4W regimen, the study had 80% power to show a statistically significant difference in percentage of responders at Week 26 between the two treatment groups, when there is a true difference of 16% in percentage of responders in favor of the Q2W regimen, and using a 2-sided chi-square at the 5% significance level.||1.7|0.7|0.696
72375623|NCT00899353|144261541|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.1|STANDARD_ERROR_OF_MEAN|2.7||0.78|TWO_SIDED|95.0|-5.0|11.2|||ANOVA|Games-Howell Correction was applied to adjust for unequal variances, unequal sample size and for non-parametric distribution.||"Omnibus analysis. Statistical significance was determined by Games Howell Multiple Comparison test. Significance was determined as α\< 0.05.~Analysis based on global response."||11.2|-5.0|0.78
72375624|NCT00899353|144261541|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.0|STANDARD_ERROR_OF_MEAN|2.5||0.75|TWO_SIDED|95.0|-4.6|10.7|||ANOVA|Games-Howell Correction was applied to adjust for unequal variances, unequal sample size and for non-parametric distribution.||"Omnibus analysis. Statistical significance was determined by Games Howell Multiple Comparison test. Significance was determined as α\< 0.05.~Analysis based on global response."||10.7|-4.6|0.75
72375625|NCT00899353|144261541|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.6|STANDARD_ERROR_OF_MEAN|2.3||0.08|TWO_SIDED|95.0|-0.6|13.7|||ANOVA|Games-Howell Correction was applied to adjust for unequal variances, unequal sample size and for non-parametric distribution.||"Omnibus analysis. Statistical significance was determined by Games Howell Multiple Comparison test. Significance was determined as α\< 0.05.~Analysis based on global response."||13.7|-0.6|0.08
72375626|NCT00899353|144261541|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.8|STANDARD_ERROR_OF_MEAN|2.4||0.17|TWO_SIDED|95.0|-1.6|13.2|||ANOVA|Games-Howell Correction was applied to adjust for unequal variances, unequal sample size and for non-parametric distribution.||"Omnibus analysis. Statistical significance was determined by Games Howell Multiple Comparison test. Significance was determined as α\< 0.05.~Analysis based on global response."||13.2|-1.6|0.17
72375627|NCT00899353|144261541|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.3|STANDARD_ERROR_OF_MEAN|3.7||0.61|TWO_SIDED|95.0|-6.5|17.2|||ANOVA|Games-Howell Correction was applied to adjust for unequal variances, unequal sample size and for non-parametric distribution.||"Omnibus analysis. Statistical significance was determined by Games Howell Multiple Comparison test. Significance was determined as α\< 0.05.~Analysis based on High Initial NFkB Activation Expressers."||17.2|-6.5|0.61
72375628|NCT00899353|144261541|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.3|STANDARD_ERROR_OF_MEAN|3.1||0.32|TWO_SIDED|95.0|-4.1|16.8|||ANOVA|Games-Howell Correction was applied to adjust for unequal variances, unequal sample size and for non-parametric distribution.||"Omnibus analysis. Statistical significance was determined by Games Howell Multiple Comparison test. Significance was determined as α\< 0.05.~Analysis based on High Initial NFkB Activation Expressers."||16.8|-4.1|0.32
72375629|NCT00899353|144261541|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.0|STANDARD_ERROR_OF_MEAN|2.8||0.03|TWO_SIDED|95.0|1.6|22.3|||ANOVA|Games-Howell Correction was applied to adjust for unequal variances, unequal sample size and for non-parametric distribution.||"Omnibus analysis. Statistical significance was determined by Games Howell Multiple Comparison test. Significance was determined as α\< 0.05.~Analysis based on High Initial NFkB Activation Expressers."||22.3|1.6|0.03
72375630|NCT00899353|144261541|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.1|STANDARD_ERROR_OF_MEAN|3.1||0.04|TWO_SIDED|95.0|0.5|21.8|||ANOVA|Games-Howell Correction was applied to adjust for unequal variances, unequal sample size and for non-parametric distribution.||"Omnibus analysis. Statistical significance was determined by Games Howell Multiple Comparison test. Significance was determined as α\< 0.05.~Analysis based on High Initial NFkB Activation Expressers."||21.8|0.5|0.04
72375631|NCT00899353|144261541|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.4||1|TWO_SIDED|95.0|-1.5|1.2|||ANOVA|Games-Howell Correction was applied to adjust for unequal variances, unequal sample size and for non-parametric distribution.||"Omnibus analysis. Statistical significance was determined by Games Howell Multiple Comparison test. Significance was determined as α\< 0.05.~Analysis based on Low Initial NFkB Activation Expressers."||1.2|-1.5|1.00
72375632|NCT00899353|144261541|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.7||0.88|TWO_SIDED|95.0|-3.5|2.3|||ANOVA|Games-Howell Correction was applied to adjust for unequal variances, unequal sample size and for non-parametric distribution.||"Omnibus analysis. Statistical significance was determined by Games Howell Multiple Comparison test. Significance was determined as α\< 0.05.~Analysis based on Low Initial NFkB Activation Expressers."||2.3|-3.5|0.88
72375633|NCT00899353|144261541|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.3||0.98|TWO_SIDED|95.0|-0.8|1.0|||ANOVA|Games-Howell Correction was applied to adjust for unequal variances, unequal sample size and for non-parametric distribution.||"Omnibus analysis. Statistical significance was determined by Games Howell Multiple Comparison test. Significance was determined as α\< 0.05.~Analysis based on Low Initial NFkB Activation Expressers."||1.0|-0.8|0.98
72375634|NCT00899353|144261541|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|1.2||0.98|TWO_SIDED|95.0|-6.6|5.3|||ANOVA|Games-Howell Correction was applied to adjust for unequal variances, unequal sample size and for non-parametric distribution.||"Omnibus analysis. Statistical significance was determined by Games Howell Multiple Comparison test. Significance was determined as α\< 0.05.~Analysis based on Low Initial NFkB Activation Expressers."||5.3|-6.6|0.98
72433545|NCT04888585|144380261|SUPERIORITY||Response Rate Difference|2.0||||0.424|TWO_SIDED|95.0|-2.8|6.8|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted for the stratification factors.|Response Rate Difference = ABBV-154 150mg EOW - Placebo|||6.8|-2.8|0.424
72375635|NCT01247298|144261546|OTHER||Kaplan Meier Estimate|82.0|||||TWO_SIDED||||||||Kaplan Meier Estimates of Progression Free Survival (PFS)|||||
72375636|NCT02650921|144261557|SUPERIORITY||Difference in Responder Rate|64.7|||<|0.0001|TWO_SIDED|95.0|53.3|76.1|||McNemar|||||76.1|53.3|<0.0001
72375637|NCT02650921|144261558|SUPERIORITY||Difference in Responder Rate|72.3|||<|0.0001|TWO_SIDED|95.0|61.9|82.7|||McNemar|||||82.7|61.9|<0.0001
72375638|NCT02650921|144261559|SUPERIORITY||Difference in Responder Rate|57.3|||<|0.0001|TWO_SIDED|95.0|44.8|69.8|||McNemar|||||69.8|44.8|<0.0001
72375639|NCT02650921|144261560|SUPERIORITY||Difference in Responder Rate|45.8|||<|0.0001|TWO_SIDED|95.0|32.3|59.3|||McNemar|||||59.3|32.3|<0.0001
72375640|NCT01087788|144261591|SUPERIORITY_OR_OTHER||Difference in Percentages|33.7|||<|0.001|TWO_SIDED|95.0|22.8|44.6||Difference of Certolizumab Pegol 200 mg versus Placebo (and corresponding 95 % Confidence Interval and p-value) were estimated using a standard two-sided Wald asymptotic test with a 5 % alpha level.|Wald-test, 2-sided|||A hierarchical test procedure was applied to protect the overall significance level for the multiplicity of dose groups and endpoints. Conditional on the first test being significant, the second hypothesis was tested with the same alpha level of 5 %. Statistical testing for the following hypotheses was performed only if the previous null hypothesis in the hierarchy was rejected.||44.6|22.8|<0.001
72395089|NCT00720434|144296638|SUPERIORITY_OR_OTHER||Difference in Proportions|-0.2|||||TWO_SIDED|95.0|-0.6191|0.2811||||||Week 72: The difference in proportions between treatment groups presented along with 95% CI, were based on exact method for small samples from the binomial distribution.||0.2811|-0.6191|
72375641|NCT01087788|144261591|SUPERIORITY_OR_OTHER||Difference in Percentages|27.6|||<|0.001|TWO_SIDED|95.0|16.5|38.7||Difference of Certolizumab Pegol 400 mg versus Placebo (and corresponding 95 % Confidence Interval and p-value) were estimated using a standard two-sided Wald asymptotic test with a 5 % alpha level.|Wald-test, 2-sided|||A hierarchical test procedure was applied to protect the overall significance level for the multiplicity of dose groups and endpoints. Conditional on the first test being significant, the second hypothesis was tested with the same alpha level of 5 %. Statistical testing for the following hypotheses was performed only if the previous null hypothesis in the hierarchy was rejected.||38.7|16.5|<0.001
72375642|NCT01087788|144261592|SUPERIORITY_OR_OTHER||Least Square Mean Difference (Net)|-10.64|STANDARD_ERROR_OF_MEAN|8.35|=|0.203|TWO_SIDED|95.0|-27.05|5.77||Diff. of CZP 200mg+400mg versus PBO (and corresponding 95% Confidence Interval and p-value) were estimated using an ANCOVA model with treatment, region and prior Tumor Necrosis Factor(TNF)-antagonist exposure as factors \& BL mTSS score as a covariate|ANCOVA|||A hierarchical test procedure was applied to protect the overall significance level for the multiplicity of dose groups and endpoints. Conditional on the first test being significant, the second hypothesis was tested with the same alpha level of 5 %. Statistical testing for the following hypotheses was performed only if the previous null hypothesis in the hierarchy was rejected. This is the pre-defined primary analysis.||5.77|-27.05|=0.203
72555891|NCT01075282|144643208|NON_INFERIORITY_OR_EQUIVALENCE|Family-wise Type I error rate was controlled by applying gatekeeping strategy.|LS Mean Difference|-0.51|||<|0.001|TWO_SIDED|95.0|-0.65|-0.37||Treatment comparison at 26 weeks. P-value is adjusted for multiplicity, based on tree-gatekeeping strategy, and compared to the family-wise 1-sided Type I error of 0.025. The confidence interval is not adjusted for multiplicity.|ANCOVA|||Non-inferiority analysis.||-0.37|-0.65|<0.001
72375643|NCT01087788|144261592|SUPERIORITY_OR_OTHER||Least Square Mean Difference (Net)|-0.21|STANDARD_ERROR_OF_MEAN|0.09|=|0.017|TWO_SIDED|95.0|-0.38|-0.04||Difference of CZP 200 mg versus Placebo (and corresponding 95 % Confidence Interval and p-value) were estimated using an ANCOVA model with treatment, region and prior TNF-antagonist exposure as factors and Baseline mTSS score as a covariate.|ANCOVA|||A hierarchical test procedure was applied to protect the overall significance level for the multiplicity of dose groups and endpoints.Conditional on the 1st test being significant, the 2nd hypothesis was tested with the same alpha level of 5%. Stat. testing for the following hypotheses was performed only if the previous null hypothesis in the hierarchy was rejected Re-analysis approach, restricted to subjects in the RS who have at least 2 x-ray values at scheduled visits (at least 8 wks apart)||-0.04|-0.38|=0.017
72375644|NCT01087788|144261592|SUPERIORITY_OR_OTHER||Least Square Mean Difference (Net)|-0.1|STANDARD_ERROR_OF_MEAN|0.09|=|0.261|TWO_SIDED|95.0|-0.27|0.07||Difference of CZP 400 mg versus Placebo (and corresponding 95 % Confidence Interval and p-value) were estimated using an ANCOVA model with treatment, region and prior TNF-antagonist exposure as factors and Baseline mTSS score as a covariate.|ANCOVA|||A hierarchical test procedure was applied to protect the overall significance level for the multiplicity of dose groups and endpoints.Conditional on the 1st test being significant, the 2nd hypothesis was tested with the same alpha level of 5%. Stat. testing for the following hypotheses was performed only if the previous null hypothesis in the hierarchy was rejected Re-analysis approach, restricted to subjects in the RS who have at least 2 x-ray values at scheduled visits (at least 8 wks apart)||0.07|-0.27|=0.261
72375645|NCT01087788|144261593|SUPERIORITY_OR_OTHER||Difference in Percentages|40.2|||<|0.001|TWO_SIDED|95.0|29.5|51.0||Difference of Certolizumab Pegol 200 mg versus Placebo (and corresponding 95 % Confidence Interval and p-value) were estimated using a standard two-sided Wald asymptotic test with a 5 % alpha level.|Wald-test, 2-sided|||A hierarchical test procedure was applied to protect the overall significance level for the multiplicity of dose groups and endpoints. Conditional on the first test being significant, the second hypothesis was tested with the same alpha level of 5 %. Statistical testing for the following hypotheses was performed only if the previous null hypothesis in the hierarchy was rejected.||51.0|29.5|<0.001
72375646|NCT01087788|144261593|SUPERIORITY_OR_OTHER||Difference in Percentages|32.8|||<|0.001|TWO_SIDED|95.0|21.8|43.8||Difference of Certolizumab Pegol 400 mg versus Placebo (and corresponding 95 % Confidence Interval and p-value) were estimated using a standard two-sided Wald asymptotic test with a 5 % alpha level.|Wald-test, 2-sided|||A hierarchical test procedure was applied to protect the overall significance level for the multiplicity of dose groups and endpoints. Conditional on the first test being significant, the second hypothesis was tested with the same alpha level of 5 %. Statistical testing for the following hypotheses was performed only if the previous null hypothesis in the hierarchy was rejected.||43.8|21.8|<0.001
72375647|NCT01087788|144261594|SUPERIORITY_OR_OTHER||Least Square Mean Difference (Net)|-0.31|STANDARD_ERROR_OF_MEAN|0.06|<|0.001|TWO_SIDED|95.0|-0.42|-0.2||Difference of CZP 200 mg + 400 mg vs. Placebo (and corresponding 95 % Confidence Interval and p-value) were estimated using an ANCOVA model with treatment, region and prior TNF-antagonist exposure as factors and Baseline HAQ-DI score as a covariate.|ANCOVA|||A hierarchical test procedure was applied to protect the overall significance level for the multiplicity of dose groups and endpoints. Conditional on the first test being significant, the second hypothesis was tested with the same alpha level of 5 %. Statistical testing for the following hypotheses was performed only if the previous null hypothesis in the hierarchy was rejected.||-0.20|-0.42|<0.001
72375648|NCT01087788|144261595|SUPERIORITY_OR_OTHER||Difference in Percentages|46.3|||<|0.001|TWO_SIDED|95.0|35.7|56.9||Difference of Certolizumab Pegol 200 mg + 400 mg versus Placebo (and corresponding 95 % Confidence Interval and p-value) were estimated using a standard two-sided Wald asymptotic test with a 5 % alpha level.|Wald-test, 2-sided|||A hierarchical test procedure was applied to protect the overall significance level for the multiplicity of dose groups and endpoints. Conditional on the first test being significant, the second hypothesis was tested with the same alpha level of 5 %. Statistical testing for the following hypotheses was performed only if the previous null hypothesis in the hierarchy was rejected.||56.9|35.7|<0.001
72433546|NCT04888585|144380261|SUPERIORITY||Response Rate Difference|2.6||||0.303|TWO_SIDED|95.0|-2.3|7.5|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted for the stratification factors.|Response Rate Difference = ABBV-154 340mg EOW - Placebo|||7.5|-2.3|0.303
72375649|NCT01087788|144261596|SUPERIORITY_OR_OTHER||Least Square Mean Difference (Net)|-0.19|STANDARD_ERROR_OF_MEAN|0.12|=|0.127|TWO_SIDED|95.0|-0.43|0.05||Difference of CZP 200 mg + 400 mg versus Placebo (and corresponding 95 % Confidence Interval and p-value) were estimated using an ANCOVA model with treatment, region and prior TNF-antagonist exposure as factors and Baseline mTSS score as a covariate.|ANCOVA|||A hierarchical test procedure was applied to protect the overall significance level for the multiplicity of dose groups and endpoints. Conditional on the first test being significant, the second hypothesis was tested with the same alpha level of 5 %. Statistical testing for the following hypotheses was performed only if the previous null hypothesis in the hierarchy was rejected. This is the predefined analysis.||0.05|-0.43|=0.127
72375650|NCT01087788|144261596|SUPERIORITY_OR_OTHER||Least Square Mean Difference (Net)|-0.52|STANDARD_ERROR_OF_MEAN|0.26|=|0.048|TWO_SIDED|95.0|-1.04|-0.01||Difference of CZP 200 mg + 400 mg versus Placebo (and corresponding 95 % Confidence Interval and p-value) were estimated using an ANCOVA model with treatment, region and prior TNF-antagonist exposure as factors and Baseline mTSS score as a covariate.|ANCOVA|||A hierarchical test procedure was applied to protect the overall significance level for the multiplicity of dose groups and endpoints. Conditional on the first test being significant, the second hypothesis was tested with the same alpha level of 5 %. Statistical testing for the following hypotheses was performed only if the previous null hypothesis in the hierarchy was rejected. This is the post-hoc analysis for the subgroup 'Baseline mTSS \> 6'.||-0.01|-1.04|=0.048
72375651|NCT00160667|144261610|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.29|||=|0.965|TWO_SIDED|95.0|-12.82|13.41|||ANCOVA||Estimated value is the difference of Least Square Means.|||13.41|-12.82|=0.965
72375652|NCT00160667|144261610|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.48|||=|0.825|TWO_SIDED|95.0|-11.69|14.65|||ANCOVA||Estimated value is the difference of Least Square Means.|||14.65|-11.69|=0.825
72375653|NCT01779219|144261626|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED|||||Fisher's exact test (two-tailed)|Fisher Exact|||||||1.0
72375654|NCT01779219|144261627|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Fisher Exact|||||||1.0
72375655|NCT01779219|144261628|SUPERIORITY_OR_OTHER|||||||0.16|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Total length of hospital stay||||0.16
72375656|NCT01779219|144261628|SUPERIORITY_OR_OTHER|||||||0.73|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Length of the preoperative hospital stay||||0.73
72375657|NCT01779219|144261628|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Length of the postoperative hospital stay||||1.0
72375658|NCT01779219|144261629|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Total OR time||||<0.001
72375659|NCT01779219|144261629|SUPERIORITY_OR_OTHER|||||||0.004|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Time of preoperative preparations||||0.004
72375660|NCT01779219|144261629|SUPERIORITY_OR_OTHER|||||||0.024|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||"Time of the operation (skin-to-skin)"||||0.024
72375661|NCT00534313|144261637|SUPERIORITY_OR_OTHER||Difference|22.9||||0.022|TWO_SIDED|95.0|4.0|41.8||The p-value (two-sided) was based on Cochran-Mantel-Haenszel method (CMH) with stratification of baseline body surface area (BSA) affected by psoriasis.|Cochran-Mantel-Haenszel||Difference was based on CMH with stratification of baseline BSA affected by psoriasis.|||41.8|4.0|0.022
72375662|NCT00534313|144261637|SUPERIORITY_OR_OTHER||Difference|28.7||||0.006|TWO_SIDED|95.0|9.4|48.0||p-value (two-sided) was based on CMH with stratification of baseline BSA affected by psoriasis.|Cochran-Mantel-Haenszel||Difference was based on CMH with stratification of baseline BSA affected by psoriasis.|||48.0|9.4|0.006
72375663|NCT00534313|144261637|SUPERIORITY_OR_OTHER||Difference|14.6||||0.121|TWO_SIDED|95.0|-3.5|32.6||p-value (2-sided) was based on CMH with stratification of baseline BSA affected by psoriasis.|Cochran-Mantel-Haenszel||Difference was based on CMH with stratification of baseline BSA affected by psoriasis.|||32.6|-3.5|0.121
72375664|NCT00534313|144261644|SUPERIORITY_OR_OTHER||Difference|-6.0|||||TWO_SIDED|95.0|-23.0|11.0|||Cochran-Mantel-Haenszel||Difference and 95% confidence intervals (CI) was based on CMH with stratification of baseline BSA affected by psoriasis.|||11.0|-23.0|
72375665|NCT00534313|144261644|SUPERIORITY_OR_OTHER||Difference|-0.5|||||TWO_SIDED|95.0|-18.0|17.1|||Cochran-Mantel-Haenszel||Difference and 95% CI was based on CMH with stratification of baseline BSA affected by psoriasis.|||17.1|-18.0|
72433547|NCT04888585|144380261|SUPERIORITY||Response Rate Difference|1.3||||0.551|TWO_SIDED|95.0|-2.9|5.4|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted for the stratification factors.|Response Rate Difference = ABBV-154 340 E4W - Placebo|||5.4|-2.9|0.551
72375666|NCT00534313|144261644|SUPERIORITY_OR_OTHER||Difference|10.4|||||TWO_SIDED|95.0|-7.6|28.5|||Cochran-Mantel-Haenszel||Difference and 95% CI was based on CMH with stratification of baseline BSA affected by psoriasis.|||28.5|-7.6|
72375667|NCT00534313|144261645|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|18.77|||||TWO_SIDED|95.0|-7.02|44.56|||ANCOVA|||||44.56|-7.02|
72375668|NCT00534313|144261645|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|22.34|||||TWO_SIDED|95.0|-3.93|48.6|||ANCOVA|||||48.60|-3.93|
72375669|NCT00534313|144261645|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|30.48|||||TWO_SIDED|95.0|4.82|56.15|||ANCOVA|||||56.15|4.82|
72375670|NCT00534313|144261647|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.08||||||95.0|-4.79|8.96|||ANCOVA|ANCOVA model with treatment as factor and baseline value as covariate was used for the analysis.||||8.96|-4.79|
72375671|NCT00534313|144261647|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.01|||||TWO_SIDED|95.0|-4.94|8.95|||ANCOVA|ANCOVA model with treatment as factor and baseline value as covariate was used for the analysis.||||8.95|-4.94|
72375672|NCT00534313|144261647|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.75|||||TWO_SIDED|95.0|-6.08|7.58|||ANCOVA|ANCOVA model with treatment as factor and baseline value as covariate was used for the analysis.||||7.58|-6.08|
72375673|NCT00534313|144261651|SUPERIORITY_OR_OTHER||Mean Difference (Net)|7.15|||||TWO_SIDED|95.0|1.97|12.33|||ANCOVA|Analysis of covariance (ANCOVA) model with treatment as factor and baseline value as covariate was used for the analysis.||||12.33|1.97|
72375674|NCT00534313|144261651|SUPERIORITY_OR_OTHER||Mean Difference (Net)|9.12|||||TWO_SIDED|95.0|3.83|14.41|||ANCOVA|ANCOVA model with treatment as factor and baseline value as covariate was used for the analysis||||14.41|3.83|
72375675|NCT00534313|144261651|SUPERIORITY_OR_OTHER||Mean Difference (Net)|6.17|||||TWO_SIDED|95.0|1.01|11.32|||ANCOVA|ANCOVA model with treatment as factor and baseline value as covariate was used for the analysis.||||11.32|1.01|
72375676|NCT00534313|144261652|SUPERIORITY_OR_OTHER||Difference|16.0|||||TWO_SIDED|95.0|-2.5|34.5|||Cochran-Mantel-Haenszel||Difference and 95% CI was based on CMH with stratification of baseline BSA affected by psoriasis.|||34.5|-2.5|
72375677|NCT00534313|144261652|SUPERIORITY_OR_OTHER||Difference|26.1||||||95.0|6.8|45.5|||Cochran-Mantel-Haenszel||Difference and 95% CI was based on CMH with stratification of baseline BSA affected by psoriasis.|||45.5|6.8|
72375678|NCT00534313|144261652|SUPERIORITY_OR_OTHER||Difference|16.6||||||95.0|-1.8|34.9|||Cochran-Mantel-Haenszel||Difference and 95% CI was based on CMH with stratification of baseline BSA affected by psoriasis.|||34.9|-1.8|
72375679|NCT03044574|144261672|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||<0.001
72375680|NCT03044574|144261673|SUPERIORITY|||||||0.03|||||||Fisher Exact|||||||0.03
72375681|NCT03044574|144261674|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||<0.001
72375682|NCT03044574|144261675|SUPERIORITY|||||||0.03|||||||Fisher Exact|||||||0.03
72375683|NCT03044574|144261676|SUPERIORITY||||||>|0.05|||||||Fisher Exact|||||||>0.05
72375684|NCT03044574|144261677|SUPERIORITY||||||>|0.05|||||||Fisher Exact|||||||>0.05
72375685|NCT03044574|144261678|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||<0.001
72375686|NCT03044574|144261680|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||<0.001
72375687|NCT01402427|144261688|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.01||||0.28|TWO_SIDED|95.0|-0.011|0.033|||Fisher Exact|||||0.033|-0.011|0.28
72375688|NCT01402427|144261689|SUPERIORITY_OR_OTHER|||||||0.11|||||||Fisher Exact|||||||0.11
72375689|NCT01402427|144261690|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Fisher Exact|||||||<0.0001
72433548|NCT04888585|144380262|SUPERIORITY||Least Squares (LS) Mean Difference|-0.18||||0.022|TWO_SIDED|95.0|-0.33|-0.03|||Mixed Models Analysis|MMRM model includes treatment, visit, treatment-by-visit interaction, stratification factors, and the baseline measurement as covariates.|ABBV-154 40mg EOW - Placebo|||-0.03|-0.33|0.022
72375690|NCT01402427|144261691|SUPERIORITY_OR_OTHER|||||||0.37|||||||Wilcoxon (Mann-Whitney)|||||||0.37
72375691|NCT01402427|144261692|SUPERIORITY_OR_OTHER|||||||0.28|||||||Wilcoxon (Mann-Whitney)|||||||0.28
72375692|NCT01402427|144261693|SUPERIORITY_OR_OTHER|||||||0.74|||||||Wilcoxon (Mann-Whitney)|||||||0.74
72375693|NCT01402427|144261694|SUPERIORITY_OR_OTHER|||||||0.45|||||||Fisher Exact|||||||0.45
72375694|NCT04355728|144261696|SUPERIORITY|||||||0.04|||||||Fisher Exact|||"The null hypothesis is the following: There is no difference in the number of subjects experiencing serious adverse events in the UC-MSC vs control group."||||.04
72375695|NCT04355728|144261705|SUPERIORITY||Hazard Ratio (HR)|0.289||||0.0307|TWO_SIDED|95.0|0.088|0.948|||Log Rank||Censoring was limited to dropout from study, and the event of interest was recovery. In the case of death, the patient's time to recovery was censored at the end of study observation; thus the patient remained in the risk set for all KM estimations.|"The null hypothesis is the following: There is no difference in Time to Recovery up to 31 days post infusion between the UC-MSC group and control group. Time to recovery was estimated in each group with Kaplan-Meier survival estimates. Log-rank tests were used to compare hazards between groups."||0.948|0.088|0.0307
72375696|NCT04355728|144261706|SUPERIORITY|||||||0.0563|||||||Wilcoxon (Mann-Whitney)|||Null Hypothesis: The center of the distributions of ventilator free days are equal in the UC-MSC and control group.||||.0563
72375697|NCT04355728|144261707|SUPERIORITY|||||||0.0563|||||||Wilcoxon (Mann-Whitney)|||Null Hypothesis: The center of the distributions of ventilator free days are equal in the UC-MSC and control group.||||.0563
72375698|NCT04355728|144261738|SUPERIORITY|||||||0.0356|||||||Wilcoxon (Mann-Whitney)|||||||0.0356
72375699|NCT04355728|144261739|SUPERIORITY|||||||0.0215|||||||Wilcoxon (Mann-Whitney)|||||||0.0215
72375700|NCT04355728|144261740|SUPERIORITY||Mean Difference (Net)|-3498.0|STANDARD_DEVIATION|3078.2||0.021|TWO_SIDED|95.0|-6404.7|-591.2|||t-test, 2 sided|||||-591.2|-6404.7|0.0210
72375701|NCT04355728|144261742|SUPERIORITY|||||||0.48|||||||Fisher Exact|||"The null hypothesis is the following: There is no association between PRA (class I) status and treatment group at 3 days post first infusion."||||0.48
72375702|NCT04355728|144261742|SUPERIORITY|||||||0.41|||||||Fisher Exact|||"The null hypothesis is the following: There is no association between PRA (class II) status and treatment group at 3 days post first infusion."||||0.41
72375703|NCT04355728|144261743|SUPERIORITY|||||||1|||||||Fisher Exact|||"The null hypothesis is the following: There is no association between PRA (class I) status and treatment group at 6 days post first infusion."||||1.00
72375704|NCT04355728|144261743|SUPERIORITY|||||||1|||||||Fisher Exact|||"The null hypothesis is the following: There is no association between PRA (Class II) status and treatment group at 6 days post first infusion."||||1.00
72375705|NCT04355728|144261744|SUPERIORITY|||||||0.44|||||||Fisher Exact|||"The null hypothesis is the following: There is no association between PRA (class I) status and treatment group at 14 days post first infusion."||||0.44
72375706|NCT04355728|144261744|SUPERIORITY|||||||0.5238|||||||Fisher Exact|||"The null hypothesis is the following: There is no association between PRA (class II) status and treatment group at 14 days post first infusion."||||0.5238
72375707|NCT00608569|144261789|SUPERIORITY_OR_OTHER|||||||0.133||95.0||||Results were considered to be statistically significant if p\<0.05|Fisher Exact|||Fisher exact test (unstratified)||||0.133
72375708|NCT02282293|144261797|OTHER||Risk Ratio (RR)|1.96||||0.5|TWO_SIDED|95.0|0.5|7.61||Calculated p-value|Chi-squared|||||7.61|0.50|0.50
72375709|NCT02282293|144261799|OTHER||Risk Ratio (RR)|1.96||||0.5|TWO_SIDED|95.0|0.5|7.61|||Chi-squared|||||7.61|0.50|0.50
72375710|NCT02282293|144261801|OTHER||Risk Ratio (RR)|0.45||||0.19|TWO_SIDED|95.0|0.13|1.48||Calculated p-value|GEE|||||1.48|0.13|0.19
72375711|NCT02282293|144261802|OTHER||Risk Ratio (RR)|1.33||||0.35|TWO_SIDED|95.0|0.72|2.45|||Chi-squared|||||2.45|0.72|0.35
72375712|NCT03381729|144261816|SUPERIORITY||Difference in Percent|-6.0|||>|0.9999|TWO_SIDED|95.0|-21.8|22.8|||Fisher Exact|||Difference in the percentage of participants who achieved the ability to stand alone.|Data for the current study were compared to historical control data (Finkel et al 2014 - PubMed 25080519) where 7 (13.7%) participants achieved the ability to stand alone and 44 (86.3%) participants did not achieve the ability to stand alone.|22.8|-21.8|>0.9999
72375713|NCT03381729|144261817|SUPERIORITY||Difference Between Least Squares Mean|5.5||||0.0027|TWO_SIDED|95.0|1.9|9.0|||Mixed-Model Repeat Measure||||Data for the current study were compared to historical control data (Finkel et al 2014 - PubMed 25080519) where the least squares mean (95% confidence interval) of the change from baseline in HFMSE scores at 12 months was 0.5 (-2.2 to 3.2).|9.0|1.9|0.0027
72375714|NCT03381729|144261819|SUPERIORITY||Percentage Difference|-2.1|||>|0.9999|TWO_SIDED|95.0|-17.2|27.0|||Fisher Exact|||Difference in the percentage of participants who achieved the ability to walk alone.|Data for the current study were compared to historical control data (Finkel et al 2014 PubMed 25080519) where 5 (9.8%) participants achieved the ability to walk alone and 46 (90.2%) participants did not achieve the ability to walk alone.|27.0|-17.2|>0.9999
72375715|NCT03758755|144261821|EQUIVALENCE|The a priori threshold for statistical significance was set at 0.05.||||||0.0219|||||||t-test, 1 sided|||Null hypothesis: there is no difference between groups in IKDC score at 12 weeks post-op.||||0.0219
72375716|NCT03758755|144261822|EQUIVALENCE|The a priori threshold for statistical significance was set at 0.05.||||||0.008|||||||t-test, 1 sided|||Null hypothesis: there is no difference between groups in VAS score at 12 weeks post-op.||||0.008
72375717|NCT03758755|144261823|EQUIVALENCE|The a priori threshold for statistical significance was set at 0.05.||||||0.011|||||||t-test, 1 sided|||This analysis compares the change over time in quadriceps tendon strength between the BFR Therapy group and the No BFR Group. Underlying data was collected on a biweekly basis as the percent difference of the operated knee compared to the contralateral side. This statistical test utilized the null hypothesis that there would be no difference between groups in the change in quadriceps tendon strength over time.||||0.011
72375718|NCT03758755|144261824|EQUIVALENCE|The a priori threshold for statistical significance was set at 0.05.||||||0.223|||||||t-test, 1 sided|||This analysis compares the change over time in thigh circumference between the BFR Therapy group and the No BFR Group. Underlying data was collected on a biweekly basis as the percent difference of the operated knee compared to the contralateral side. This statistical test utilized the null hypothesis that there would be no difference between groups in the change in thigh circumference over time.||||0.223
72375719|NCT03758755|144261825|EQUIVALENCE|The a priori threshold for statistical significance was set at 0.05.||||||0.242|||||||t-test, 1 sided|||This analysis compares the change over time in degrees of knee flexion between the BFR Therapy group and the No BFR Group from 2 weeks post-op to 12 weeks post-op. Underlying data was collected on a biweekly basis. This statistical test utilized the null hypothesis that there would be no difference between groups in the change in degrees of knee flexion over time.||||0.242
72375720|NCT03758755|144261826|EQUIVALENCE|The a priori threshold for statistical significance was set at 0.05.||||||0.049|||||||t-test, 1 sided|||This analysis compares the change over time in degrees of knee extension between the BFR Therapy group and the No BFR Group from 2 weeks post-op to 12 weeks post-op. Underlying data was collected on a biweekly basis. This statistical test utilized the null hypothesis that there would be no difference between groups in the change in degrees of knee extension over time.||||0.049
72375721|NCT00906971|144261844|NON_INFERIORITY_OR_EQUIVALENCE|Statistical analysis to compare the two groups at the end of the follow-up period with regard to the primary outcome measures was blind, by intention-to-treat, considering loss of follow-up as treatment failure. In such cases, at the end of the follow-up period, the frequency of defecations was recorded.|||||<|0.05|||||||t-test, 1 sided|The Mann-Whitney test was used for numerical variables with non-normal distribution.||||||<0.05
72375722|NCT00906971|144261845|NON_INFERIORITY_OR_EQUIVALENCE|Statistical analysis to compare the two groups at the end of the follow-up period with regard to the primary outcome measures was blind, by intention-to-treat, considering loss of follow-up as treatment failure. In such cases, at the end of the follow-up period, the frequency of fecal incontinence was recorded reported at the beginning of the study|||||>|0.05|||||||t-test, 1 sided|The Mann-Whitney test was used for numerical variables with non-normal distribution.||||||>0.05
72375723|NCT01634191|144261865|OTHER||Geometric Mean Ratio|113.0|||||TWO_SIDED|90.0|94.2|135.0|||||Geometric mean ratio (Elderly/Young) and 90% confidence interval (CI) of the ratio calculated from a 2-way ANOVA model, and presented as percentages.|To assess the effect of age on the PK of apremilast after a single 30 mg dose, a 2-way analysis of variance (ANOVA) model was performed on the log-transformed AUC0-t. The ANOVA model included age group (elderly and young), sex (male and female), and age group by sex as a fixed effect.||135|94.2|
72375724|NCT01634191|144261867|OTHER||Geometric Mean Ratio|128.0|||||TWO_SIDED|90.0|107.0|154.0|||||Geometric mean ratio (Female/Male) and 90% CI of the ratio calculated from a 2-way ANOVA model, and presented as percentages.|To assess the effect of sex on the PK of apremilast after a single 30 mg dose, a 2-way analysis of variance (ANOVA) model was performed on the log-transformed AUC0-t. The ANOVA model included age group (elderly and young), sex (male and female), and age group by sex as a fixed effect.||154|107|
72375725|NCT01634191|144261868|OTHER||Geometric Mean Ratio|113.0|||||TWO_SIDED|90.0|94.1|135.0|||||Geometric mean ratio (Elderly/Young) and 90% CI of the ratio calculated from a 2-way ANOVA model, and presented as percentages.|To assess the effect of age on the PK of apremilast after a single 30 mg dose, a 2-way analysis of variance (ANOVA) model was performed on the log-transformed AUC0-∞. The ANOVA model included age group (elderly and young), sex (male and female), and age group by sex as a fixed effect.||135|94.1|
72375726|NCT01634191|144261869|OTHER||Geometric Mean Ratio|131.0|||||TWO_SIDED|90.0|109.0|157.0|||||Geometric mean ratio (Female/Male) and 90% CI of the ratio calculated from a 2-way ANOVA model, and presented as percentages.|To assess the effect of sex on the PK of apremilast after a single 30 mg dose, a 2-way ANOVA model was performed on the log-transformed AUC0-∞. The ANOVA model included age group (elderly and young), sex (male and female), and age group by sex as a fixed effect.||157|109|
72375727|NCT01634191|144261870|OTHER||Geometric Mean Ratio|106.0|||||TWO_SIDED|90.0|90.5|123.0|||||Geometric mean ratio (Elderly/Young) and 90% CI of the ratio calculated from a 2-way ANOVA model, and presented as percentages.|To assess the effect of age on the PK of apremilast after a single 30 mg dose, a 2-way analysis of ANOVA model was performed on the log-transformed Cmax. The ANOVA model included age group (elderly and young), sex (male and female), and age group by sex as a fixed effect.||123|90.5|
72433549|NCT04888585|144380262|SUPERIORITY||Least Squares (LS) Mean Difference|-0.25||||0.001|TWO_SIDED|95.0|-0.41|-0.1|||Mixed Models Analysis|MMRM model includes treatment, visit, treatment-by-visit interaction, stratification factors, and the baseline measurement as covariates.|Response Rate Difference = ABBV-154 150mg EOW - Placebo|||-0.10|-0.41|0.001
72375728|NCT01634191|144261871|OTHER||Geometric Mean Ratio|108.0|||||TWO_SIDED|90.0|92.3|126.0|||||Geometric mean ratio (Female/Male) and 90% CI of the ratio calculated from a 2-way ANOVA model, and presented as percentages.|To assess the effect of sex on the PK of apremilast after a single 30 mg dose, a 2-way ANOVA model was performed on the log-transformed Cmax. The ANOVA model included age group (elderly and young), sex (male and female), and age group by sex as a fixed effect.||126|92.3|
72375729|NCT01634191|144261872|OTHER||Median Difference|0.5||||0.153|TWO_SIDED|90.0|0.0|2.0|||Wilcoxon rank-sum test||Median difference (Elderly - Young) calculated from the Hodges-Lehmann estimate.|Tmax was analyzed by nonparametric methods. The median difference and 90% CI of the median difference were calculated from the Hodges-Lehrmann estimate.||2.00|0.000|0.153
72375730|NCT01634191|144261873|OTHER||Median Difference|0.5||||0.169|TWO_SIDED|90.0|0.0|2.0|||Wilcoxon rank-sum test||Median difference (Female - Male) and 90% CI of the difference calculated from the Hodges-Lehmann estimate.|Tmax was analyzed by nonparametric methods. The median difference and 90% CI of the median difference were calculated from the Hodges-Lehrmann estimate.||2.00|0.000|0.169
72375731|NCT02880956|144261899|SUPERIORITY||Least Squares (LS) Mean of Difference|0.06|STANDARD_ERROR_OF_MEAN|0.178||0.74|TWO_SIDED|95.0|-0.291|0.409||The statistical model: CDR change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.409|-0.291|0.740
72375732|NCT02880956|144261899|SUPERIORITY||Effect size/pooled SD|-0.04|STANDARD_DEVIATION|1.38|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
72375733|NCT02880956|144261899|SUPERIORITY||LS Mean of Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.176||0.367|TWO_SIDED|95.0|-0.504|0.187||The statistical model: CDR change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.187|-0.504|0.367
72375734|NCT02880956|144261899|SUPERIORITY||Effect size/pooled SD|0.12|STANDARD_DEVIATION|1.33|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
72375735|NCT02880956|144261899|SUPERIORITY||LS Mean of Difference|0.04|STANDARD_ERROR_OF_MEAN|0.18||0.843|TWO_SIDED|95.0|-0.318|0.389||The statistical model: CDR change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.389|-0.318|0.843
72375736|NCT02880956|144261899|SUPERIORITY||Effect size/pooled SD|-0.03|STANDARD_DEVIATION|1.37|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
72375737|NCT02880956|144261899|SUPERIORITY||LS Mean of Difference|0.08|STANDARD_ERROR_OF_MEAN|0.222||0.703|TWO_SIDED|95.0|-0.351|0.52||The statistical model: CDR change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||0.520|-0.351|0.703
72375738|NCT02880956|144261899|SUPERIORITY||Effect size/pooled SD|-0.05|STANDARD_DEVIATION|1.62|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
72375739|NCT02880956|144261899|SUPERIORITY||LS Mean of Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.218||0.947|TWO_SIDED|95.0|-0.442|0.413||The statistical model: CDR change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||0.413|-0.442|0.947
72375740|NCT02880956|144261899|SUPERIORITY||Effect size/pooled SD|-0.01|STANDARD_DEVIATION|1.69|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
72375741|NCT02880956|144261899|SUPERIORITY||LS Mean of Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.222||0.732|TWO_SIDED|95.0|-0.514|0.361||The statistical model: CDR change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||0.361|-0.514|0.732
72375742|NCT02880956|144261899|SUPERIORITY||Effect size/pooled SD|0.05|STANDARD_DEVIATION|1.51|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
72375743|NCT02880956|144261899|SUPERIORITY||LS Mean of Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.305||0.939|TWO_SIDED|95.0|-0.623|0.576||The statistical model: CDR change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||0.576|-0.623|0.939
72375744|NCT02880956|144261899|SUPERIORITY||Effect size/pooled SD|0.01|STANDARD_DEVIATION|2.19|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
72375745|NCT02880956|144261899|SUPERIORITY||LS Mean of Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.299||0.872|TWO_SIDED|95.0|-0.637|0.54||The statistical model: CDR change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||0.540|-0.637|0.872
72375746|NCT02880956|144261899|SUPERIORITY||Effect size/pooled SD|0.02|STANDARD_DEVIATION|2.27|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
72375747|NCT02880956|144261899|SUPERIORITY||LS Mean of Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.305||0.773|TWO_SIDED|95.0|-0.688|0.512||The statistical model: CDR change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||0.512|-0.688|0.773
72375748|NCT02880956|144261899|SUPERIORITY||Effect size/pooled SD|0.04|STANDARD_DEVIATION|2.13|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
72555892|NCT01075282|144643208|NON_INFERIORITY_OR_EQUIVALENCE|Family-wise Type I error rate was controlled by applying gatekeeping strategy.|LS Mean Difference|-0.24|||<|0.001|TWO_SIDED|95.0|-0.38|-0.1||Treatment comparison at 26 weeks. P-value is adjusted for multiplicity, based on tree-gatekeeping strategy, and compared to the family-wise 1-sided Type I error of 0.025. The confidence interval is not adjusted for multiplicity.|ANCOVA|||Non-inferiority analysis.||-0.10|-0.38|<0.001
72555893|NCT01075282|144643208|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.51|||<|0.001|TWO_SIDED|95.0|-0.65|-0.37||Treatment comparison at 26 weeks. P-value is adjusted for multiplicity, based on tree-gatekeeping strategy, and compared to the family-wise 1-sided Type I error of 0.025. The confidence interval is not adjusted for multiplicity.|ANCOVA|||Superiority analysis.||-0.37|-0.65|<0.001
72375749|NCT02880956|144261899|SUPERIORITY||LS Mean of Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.387||0.848|TWO_SIDED|95.0|-0.834|0.686||The statistical model: CDR change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||0.686|-0.834|0.848
72375750|NCT02880956|144261899|SUPERIORITY||Effect size/pooled SD|0.03|STANDARD_DEVIATION|2.64|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
72375751|NCT02880956|144261899|SUPERIORITY||LS Mean of Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.38||0.869|TWO_SIDED|95.0|-0.81|0.684||The statistical model: CDR change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||0.684|-0.810|0.869
72375752|NCT02880956|144261899|SUPERIORITY||Effect size/pooled SD|0.02|STANDARD_DEVIATION|2.75|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
72375753|NCT02880956|144261899|SUPERIORITY||LS Mean of Difference|0.16|STANDARD_ERROR_OF_MEAN|0.389||0.679|TWO_SIDED|95.0|-0.603|0.925||The statistical model: CDR change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||0.925|-0.603|0.679
72375754|NCT02880956|144261899|SUPERIORITY||Effect size/pooled SD|-0.06|STANDARD_DEVIATION|2.72|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
72375755|NCT02880956|144261908|SUPERIORITY||LS Mean of Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.693||0.562|TWO_SIDED|95.0|-1.764|0.96||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.960|-1.764|0.562
72375756|NCT02880956|144261908|SUPERIORITY||Effect size/pooled SD|0.08|STANDARD_DEVIATION|4.92|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
72375757|NCT02880956|144261908|SUPERIORITY||LS Mean of Difference|-1.26|STANDARD_ERROR_OF_MEAN|0.682||0.066|TWO_SIDED|95.0|-2.602|0.081||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.081|-2.602|0.066
72375758|NCT02880956|144261908|SUPERIORITY||Effect size/pooled SD|0.25|STANDARD_DEVIATION|5.08|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
72375759|NCT02880956|144261908|SUPERIORITY||LS Mean of Difference|0.03|STANDARD_ERROR_OF_MEAN|0.7||0.962|TWO_SIDED|95.0|-1.343|1.41||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||1.410|-1.343|0.962
72375760|NCT02880956|144261908|SUPERIORITY||Effect size/pooled SD|-0.01|STANDARD_DEVIATION|5.33|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
72375761|NCT02880956|144261908|SUPERIORITY||LS Mean of Difference|-0.99|STANDARD_ERROR_OF_MEAN|0.887||0.265|TWO_SIDED|95.0|-2.734|0.755||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||0.755|-2.734|0.265
72375762|NCT02880956|144261908|SUPERIORITY||Effect size/pooled SD|0.16|STANDARD_DEVIATION|6.32|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
72375763|NCT02880956|144261908|SUPERIORITY||LS Mean of Difference|-1.08|STANDARD_ERROR_OF_MEAN|0.863||0.212|TWO_SIDED|95.0|-2.775|0.618||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||0.618|-2.775|0.212
72375764|NCT02880956|144261908|SUPERIORITY||Effect size/pooled SD|0.17|STANDARD_DEVIATION|6.29|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
72375765|NCT02880956|144261908|SUPERIORITY||LS Mean of Difference|-0.47|STANDARD_ERROR_OF_MEAN|0.893||0.602|TWO_SIDED|95.0|-2.223|1.29||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||1.290|-2.223|0.602
72375766|NCT02880956|144261908|SUPERIORITY||Effect size/pooled SD|0.07|STANDARD_DEVIATION|6.35|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
72433550|NCT04888585|144380262|SUPERIORITY||Least Squares (LS) Mean Difference|-0.32|||<|0.001|TWO_SIDED|95.0|-0.48|-0.17|||Mixed Models Analysis|MMRM model includes treatment, visit, treatment-by-visit interaction, stratification factors, and the baseline measurement as covariates.|Response Rate Difference = ABBV-154 340mg EOW - Placebo|||-0.17|-0.48|<0.001
72375767|NCT02880956|144261908|SUPERIORITY||LS Mean of Difference|-0.48|STANDARD_ERROR_OF_MEAN|1.019||0.635|TWO_SIDED|95.0|-2.489|1.519||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||1.519|-2.489|0.635
72375768|NCT02880956|144261908|SUPERIORITY||Effect size/pooled SD|0.08|STANDARD_DEVIATION|6.31|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
72375769|NCT02880956|144261908|SUPERIORITY||LS Mean of Difference|-0.26|STANDARD_ERROR_OF_MEAN|1.003||0.795|TWO_SIDED|95.0|-2.233|1.712||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||1.712|-2.233|0.795
72375770|NCT02880956|144261908|SUPERIORITY||Effect size/pooled SD|0.04|STANDARD_DEVIATION|7.02|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
72555894|NCT01075282|144643208|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.24|||<|0.001|TWO_SIDED|95.0|-0.38|-0.1||Treatment comparison at 26 weeks. P-value is adjusted for multiplicity, based on tree-gatekeeping strategy, and compared to the family-wise 1-sided Type I error of 0.025. The confidence interval is not adjusted for multiplicity.|ANCOVA|||Superiority analysis.||-0.10|-0.38|<0.001
72555895|NCT01075282|144643208|NON_INFERIORITY_OR_EQUIVALENCE|Family-wise Type I error rate was controlled by applying gatekeeping strategy.|LS Mean Difference|-0.31|||<|0.001|TWO_SIDED|95.0|-0.5|-0.13||Treatment comparison at 78 weeks. P-value is adjusted for multiplicity, based on tree-gatekeeping strategy, and compared to the family-wise 1-sided Type I error of 0.025. The confidence interval is not adjusted for multiplicity.|ANCOVA|||Non-inferiority analysis.||-0.13|-0.50|<0.001
72555896|NCT01075282|144643208|NON_INFERIORITY_OR_EQUIVALENCE|Family-wise Type I error rate was controlled by applying gatekeeping strategy.|LS Mean Difference|-0.03|||<|0.001|TWO_SIDED|95.0|-0.21|0.15||Treatment comparison at 78 weeks. P-value is adjusted for multiplicity, based on tree-gatekeeping strategy, and compared to the family-wise 1-sided Type I error of 0.025. The confidence interval is not adjusted for multiplicity.|ANCOVA|||Non-inferiority analysis.||0.15|-0.21|<0.001
72555897|NCT01075282|144643208|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.31|||<|0.001|TWO_SIDED|95.0|-0.5|-0.13||Treatment comparison at 78 weeks. P-value is adjusted for multiplicity, based on tree-gatekeeping strategy, and compared to the family-wise 1-sided Type I error of 0.025. The confidence interval is not adjusted for multiplicity.|ANCOVA|||Superiority analysis.||-0.13|-0.50|<0.001
72555898|NCT01075282|144643208|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.03||||0.378|TWO_SIDED|95.0|-0.21|0.15||Treatment comparison at 78 weeks. P-value is adjusted for multiplicity, based on tree-gatekeeping strategy, and compared to the family-wise 1-sided Type I error of 0.025. The confidence interval is not adjusted for multiplicity.|ANCOVA|||Superiority analysis.||0.15|-0.21|0.378
72555899|NCT01075282|144643209|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.61|||<|0.001|TWO_SIDED|95.0|2.98|7.11||Treatment comparison at 26 weeks.|Regression, Logistic|||||7.11|2.98|<0.001
72375771|NCT02880956|144261908|SUPERIORITY||LS Mean of Difference|1.11|STANDARD_ERROR_OF_MEAN|1.027||0.281|TWO_SIDED|95.0|-0.91|3.128||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||3.128|-0.910|0.281
72375772|NCT02880956|144261908|SUPERIORITY||Effect size/pooled SD|-0.16|STANDARD_DEVIATION|7.02|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
72555900|NCT01075282|144643209|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.13|||<|0.001|TWO_SIDED|95.0|1.41|3.24||Treatment comparison at 26 weeks.|Regression, Logistic|||||3.24|1.41|<0.001
72555901|NCT01075282|144643209|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.76|||<|0.001|TWO_SIDED|95.0|2.45|5.75||Treatment comparison at 52 weeks.|Regression, Logistic|||||5.75|2.45|<0.001
72375773|NCT02880956|144261908|SUPERIORITY||LS Mean of Difference|-0.44|STANDARD_ERROR_OF_MEAN|1.261||0.729|TWO_SIDED|95.0|-2.918|2.043||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||2.043|-2.918|0.729
72375774|NCT02880956|144261908|SUPERIORITY||Effect size/pooled SD|0.06|STANDARD_DEVIATION|7.4|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
72375775|NCT02880956|144261908|SUPERIORITY||LS Mean of Difference|-0.59|STANDARD_ERROR_OF_MEAN|1.248||0.636|TWO_SIDED|95.0|-3.047|1.863||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||1.863|-3.047|0.636
72555902|NCT01075282|144643209|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.42||||0.098|TWO_SIDED|95.0|0.94|2.15||Treatment comparison at 52 weeks.|Regression, Logistic|||||2.15|0.94|0.098
72555903|NCT01075282|144643209|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.77|||<|0.001|TWO_SIDED|95.0|1.85|4.14||Treatment comparison at 78 weeks.|Regression, Logistic|||||4.14|1.85|<0.001
72555904|NCT01075282|144643209|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.22||||0.334|TWO_SIDED|95.0|0.82|1.82||Treatment comparison at 78 weeks.|Regression, Logistic|||||1.82|0.82|0.334
72555905|NCT01075282|144643210|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.7|||<|0.001|TWO_SIDED|95.0|2.9|7.63||Treatment comparison at 26 weeks.|Regression, Logistic|||||7.63|2.90|<0.001
72555906|NCT01075282|144643210|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.54|||<|0.001|TWO_SIDED|95.0|1.57|4.11||Treatment comparison at 26 weeks.|Regression, Logistic|||||4.11|1.57|<0.001
72555907|NCT01075282|144643210|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.97|||<|0.001|TWO_SIDED|95.0|1.81|4.85||Treatment comparison at 52 weeks.|Regression, Logistic|||||4.85|1.81|<0.001
72555908|NCT01075282|144643210|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.07||||0.004|TWO_SIDED|95.0|1.26|3.39||Treatment comparison at 52 weeks.|Regression, Logistic|||||3.39|1.26|0.004
72555909|NCT01075282|144643210|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.27|||<|0.001|TWO_SIDED|95.0|1.44|3.57||Treatment comparison at 78 weeks.|Regression, Logistic|Treatment comparison at 78 weeks.||||3.57|1.44|<0.001
72375776|NCT02880956|144261908|SUPERIORITY||Effect size/pooled SD|0.08|STANDARD_DEVIATION|7.46|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
72375777|NCT02880956|144261908|SUPERIORITY||LS Mean of Difference|1.03|STANDARD_ERROR_OF_MEAN|1.294||0.427|TWO_SIDED|95.0|-1.515|3.575||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||3.575|-1.515|0.427
72375778|NCT02880956|144261908|SUPERIORITY||Effect size/pooled SD|-0.13|STANDARD_DEVIATION|7.9|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
72375779|NCT02880956|144261909|SUPERIORITY||LS Mean of Difference|0.02|STANDARD_ERROR_OF_MEAN|0.053||0.69|TWO_SIDED|95.0|-0.083|0.126||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.126|-0.083|0.690
72375780|NCT02880956|144261909|SUPERIORITY||Effect size/pooled SD|-0.05|STANDARD_DEVIATION|0.39|||TWO_SIDED|95.0|||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
72375781|NCT02880956|144261909|SUPERIORITY||LS Mean of Difference|0.03|STANDARD_ERROR_OF_MEAN|0.052||0.595|TWO_SIDED|95.0|-0.075|0.131||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.131|-0.075|0.595
72375782|NCT02880956|144261909|SUPERIORITY||Effect size/pooled SD|-0.08|STANDARD_DEVIATION|0.36|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
72375783|NCT02880956|144261909|SUPERIORITY||LS Mean of Difference|0.07|STANDARD_ERROR_OF_MEAN|0.054||0.201|TWO_SIDED|95.0|0.037|0.175||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.175|0.037|0.201
72375784|NCT02880956|144261909|SUPERIORITY||Effect size/pooled SD|-0.15|STANDARD_DEVIATION|0.45|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
72375785|NCT02880956|144261909|SUPERIORITY||LS Mean of Difference|0.06|STANDARD_ERROR_OF_MEAN|0.064||0.361|TWO_SIDED|95.0|-0.067|0.184||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||0.184|-0.067|0.361
72375786|NCT02880956|144261909|SUPERIORITY||Effect size/pooled SD|-0.12|STANDARD_DEVIATION|0.49|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
72375787|NCT02880956|144261909|SUPERIORITY||LS Mean of Difference|0.04|STANDARD_ERROR_OF_MEAN|0.062||0.522|TWO_SIDED|95.0|-0.082|0.162||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|Week 48||0.162|-0.082|0.522
72375788|NCT02880956|144261909|SUPERIORITY||Effect size/pooled SD|-0.1|STANDARD_DEVIATION|0.41|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
72375789|NCT02880956|144261909|SUPERIORITY||LS Mean of Difference|0.09|STANDARD_ERROR_OF_MEAN|0.064||0.147|TWO_SIDED|95.0|-0.033|0.219||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||0.219|-0.033|0.147
72375790|NCT02880956|144261909|SUPERIORITY||Effect size/pooled SD|-0.17|STANDARD_DEVIATION|0.53|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
72375791|NCT02880956|144261909|SUPERIORITY||LS Mean of Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.091||0.492|TWO_SIDED|95.0|-0.243|0.117||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||0.117|-0.243|0.492
72375792|NCT02880956|144261909|SUPERIORITY||Effect size/pooled SD|0.11|STANDARD_DEVIATION|0.57|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
72375793|NCT02880956|144261909|SUPERIORITY||LS Mean of Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.09||0.691|TWO_SIDED|95.0|-0.213|0.141||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||0.141|-0.213|0.691
72375794|NCT02880956|144261909|SUPERIORITY||Effect size/pooled SD|0.06|STANDARD_DEVIATION|0.6|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
72375795|NCT02880956|144261909|SUPERIORITY||LS Mean of Difference|0.14|STANDARD_ERROR_OF_MEAN|0.091||0.135|TWO_SIDED|95.0|-0.043|0.317||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||0.317|-0.043|0.135
72433551|NCT04888585|144380262|SUPERIORITY||Least Squares (LS) Mean Difference|-0.21||||0.007|TWO_SIDED|95.0|-0.36|-0.06|||Mixed Models Analysis|MMRM model includes treatment, visit, treatment-by-visit interaction, stratification factors, and the baseline measurement as covariates.|Response Rate Difference = ABBV-154 340mg E4W - Placebo|||-0.06|-0.36|0.007
72433552|NCT03722446|144380267|SUPERIORITY||||||<|0.0001|||||||Chi-squared|||||||<0.0001
72375796|NCT02880956|144261909|SUPERIORITY||Effect size/pooled SD|-0.19|STANDARD_DEVIATION|0.74|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
72375797|NCT02880956|144261909|SUPERIORITY||LS Mean of Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.117||0.713|TWO_SIDED|95.0|-0.273|0.187||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||0.187|-0.273|0.713
72375798|NCT02880956|144261909|SUPERIORITY||Effect size/pooled SD|0.06|STANDARD_ERROR_OF_MEAN|0.74|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
72375799|NCT02880956|144261909|SUPERIORITY||LS Mean of Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.115||0.318|TWO_SIDED|95.0|-0.341|0.111||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||0.111|-0.341|0.318
72375800|NCT02880956|144261909|SUPERIORITY||Effect size/pooled SD|0.14|STANDARD_DEVIATION|0.8|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
72375801|NCT02880956|144261909|SUPERIORITY||LS Mean of Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.119||0.927|TWO_SIDED|95.0|-0.244|0.222||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||0.222|-0.244|0.927
72375802|NCT02880956|144261909|SUPERIORITY||Effect size/pooled SD|0.01|STANDARD_DEVIATION|0.84|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
72375803|NCT02880956|144261910|SUPERIORITY||LS Mean of Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.081||0.456|TWO_SIDED|95.0|-0.219|0.098||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 24||0.098|-0.219|0.456
72375804|NCT02880956|144261910|SUPERIORITY||Effect size/pooled SD|0.09|STANDARD_DEVIATION|0.64|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
72555910|NCT01075282|144643210|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.53||||0.073|TWO_SIDED|95.0|0.96|2.42||Treatment comparison at 78 weeks.|Regression, Logistic|||||2.42|0.96|0.073
72375805|NCT02880956|144261910|SUPERIORITY||LS Mean of Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.079||0.093|TWO_SIDED|95.0|-0.29|0.023||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 24||0.023|-0.290|0.093
72375806|NCT02880956|144261910|SUPERIORITY||Effect size/pooled SD|0.23|STANDARD_DEVIATION|0.59|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
72375807|NCT02880956|144261910|SUPERIORITY||LS Mean of Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.082||0.75|TWO_SIDED|95.0|-0.187|0.135||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 24||0.135|-0.187|0.750
72375808|NCT02880956|144261910|SUPERIORITY||Effect size/pooled SD|0.04|STANDARD_DEVIATION|0.63|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
72375809|NCT02880956|144261910|SUPERIORITY||LS Mean of Difference|0.16|STANDARD_ERROR_OF_MEAN|0.106||0.134|TWO_SIDED|95.0|-0.049|0.366||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 48||0.366|-0.049|0.134
72375810|NCT02880956|144261910|SUPERIORITY||Effect size/pooled SD|-0.2|STANDARD_DEVIATION|0.79|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
72375811|NCT02880956|144261910|SUPERIORITY||LS Mean of Difference|0.1|STANDARD_ERROR_OF_MEAN|0.103||0.316|TWO_SIDED|95.0|-0.099|0.305||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 48||0.305|-0.099|0.316
72375812|NCT02880956|144261910|SUPERIORITY||Effect size/pooled SD|-0.14|STANDARD_DEVIATION|0.72|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
72375813|NCT02880956|144261910|SUPERIORITY||LS Mean of Difference|0.13|STANDARD_ERROR_OF_MEAN|0.106||0.218|TWO_SIDED|95.0|-0.078|0.339||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 48||0.339|-0.078|0.218
72375814|NCT02880956|144261910|SUPERIORITY||Effect size/pooled SD|-0.17|STANDARD_DEVIATION|0.76|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
72375815|NCT02880956|144261910|SUPERIORITY||LS Mean of Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.099||0.799|TWO_SIDED|95.0|-0.219|0.169||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 72||0.169|-0.219|0.799
72433553|NCT03722446|144380268|SUPERIORITY|||||||0.0102|||||||t-test, 1 sided|||||||0.01020
72555911|NCT01075282|144643211|SUPERIORITY_OR_OTHER|||||||0.109||||||Treatment comparison at 26 weeks.|Mixed Models Analysis|||||||0.109
72555912|NCT01075282|144643211|SUPERIORITY_OR_OTHER|||||||0.335||||||Treatment comparison at 26 weeks.|Mixed Models Analysis|||||||0.335
72555913|NCT01075282|144643211|SUPERIORITY_OR_OTHER|||||||0.091||||||Treatment comparison at 52 weeks.|Mixed Models Analysis|||||||0.091
72375816|NCT02880956|144261910|SUPERIORITY||Effect size/pooled SD|0.04|STANDARD_DEVIATION|0.7|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
72555914|NCT01075282|144643211|SUPERIORITY_OR_OTHER|||||||0.4||||||Treatment comparison at 52 weeks.|Mixed Models Analysis|||||||0.400
72375817|NCT02880956|144261910|SUPERIORITY||LS Mean of Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.098||0.406|TWO_SIDED|95.0|-0.273|0.111||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 72||0.111|-0.273|0.406
72375818|NCT02880956|144261910|SUPERIORITY||Effect size/pooled SD|0.11|STANDARD_DEVIATION|0.74|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
72375819|NCT02880956|144261910|SUPERIORITY||LS Mean of Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.099||0.363|TWO_SIDED|95.0|-0.285|0.105||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 72||0.105|-0.285|0.363
72375820|NCT02880956|144261910|SUPERIORITY||Effect size/pooled SD|0.12|STANDARD_DEVIATION|0.76|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
72375821|NCT02880956|144261910|SUPERIORITY||LS Mean of Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.125||0.22|TWO_SIDED|95.0|-0.4|0.093||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 96||0.093|-0.400|0.220
72375822|NCT02880956|144261910|SUPERIORITY||Effect size/pooled SD|0.18|STANDARD_DEVIATION|0.85|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
72375823|NCT02880956|144261910|SUPERIORITY||LS Mean of Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.123||0.245|TWO_SIDED|95.0|-0.386|0.099||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 96||0.099|-0.386|0.245
72375824|NCT02880956|144261910|SUPERIORITY||Effect size/pooled SD|0.17|STANDARD_DEVIATION|0.83|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
72375825|NCT02880956|144261910|SUPERIORITY||LS Mean of Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.127||0.569|TWO_SIDED|95.0|-0.323|0.178||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 96||0.178|-0.323|0.569
72375826|NCT02880956|144261910|SUPERIORITY||Effect size/pooled SD|0.08|STANDARD_DEVIATION|0.95|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
72375827|NCT02880956|144261911|SUPERIORITY||LS Mean of Difference|0.01|STANDARD_ERROR_OF_MEAN|0.093||0.945|TWO_SIDED|95.0|-0.177|0.19||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 24||0.190|-0.177|0.945
72375828|NCT02880956|144261911|SUPERIORITY||Effect size/pooled SD|-0.01|STANDARD_DEVIATION|0.86|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
72555915|NCT01075282|144643211|SUPERIORITY_OR_OTHER|||||||0.641||||||Treatment comparison at 78 weeks.|Mixed Models Analysis|||||||0.641
72375829|NCT02880956|144261911|SUPERIORITY||LS Mean of Difference|0.0|STANDARD_ERROR_OF_MEAN|0.092||0.974|TWO_SIDED|95.0|-0.184|0.178||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 24||0.178|-0.184|0.974
72375830|NCT02880956|144261911|SUPERIORITY||Effect size/pooled SD|0.0|STANDARD_DEVIATION|0.74|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
72375831|NCT02880956|144261911|SUPERIORITY||LS Mean of Difference|0.0|STANDARD_ERROR_OF_MEAN|0.094||0.963|TWO_SIDED|95.0|-0.19|0.181||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||||0.181|-0.190|0.963
72375832|NCT02880956|144261911|SUPERIORITY||Effect size/pooled SD|0.01|STANDARD_DEVIATION|0.76|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
72375833|NCT02880956|144261911|SUPERIORITY||LS Mean of Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.104||0.625|TWO_SIDED|95.0|-0.255|0.154||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 48||0.154|-0.255|0.625
72433554|NCT03722446|144380269|SUPERIORITY|||||||1|||||||Chi-squared|||||||1.0000
72433555|NCT03722446|144380270|SUPERIORITY|||||||0.3753|||||||Chi-squared|||||||0.3753
72555916|NCT01075282|144643211|SUPERIORITY_OR_OTHER|||||||0.055||||||Treatment comparison at 78 weeks.|Mixed Models Analysis|||||||0.055
72555917|NCT01075282|144643214|SUPERIORITY_OR_OTHER||LS Mean Difference|2.83|||<|0.001|TWO_SIDED|95.0|2.33|3.33||Treatment comparison at 26 weeks.|ANCOVA|||||3.33|2.33|<0.001
72555918|NCT01075282|144643214|SUPERIORITY_OR_OTHER||LS Mean Difference|2.48|||<|0.001|TWO_SIDED|95.0|1.99|2.99||Treatment comparison at 26 weeks.|ANCOVA|||||2.99|1.99|<0.001
72555919|NCT01075282|144643214|SUPERIORITY_OR_OTHER||LS Mean Difference|3.31|||<|0.001|TWO_SIDED|95.0|2.71|3.9||Treatment comparison at 52 weeks.|ANCOVA|||||3.90|2.71|<0.001
72555920|NCT01075282|144643214|SUPERIORITY_OR_OTHER||LS Mean Difference|2.77|||<|0.001|TWO_SIDED|95.0|2.17|3.36||Treatment comparison at 52 weeks.|ANCOVA|||||3.36|2.17|<0.001
72375834|NCT02880956|144261911|SUPERIORITY||Effect size/pooled SD|0.07|STANDARD_DEVIATION|0.74|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
72375835|NCT02880956|144261911|SUPERIORITY||LS Mean of Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.101||0.468|TWO_SIDED|95.0|-0.272|0.125||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 48||0.125|-0.272|0.468
72375836|NCT02880956|144261911|SUPERIORITY||Effect size/pooled SD|0.1|STANDARD_DEVIATION|0.71|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
72375837|NCT02880956|144261911|SUPERIORITY||LS Mean of Difference|0.05|STANDARD_ERROR_OF_MEAN|0.104||0.636|TWO_SIDED|95.0|-0.155|0.254||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 48||0.254|-0.155|0.636
72375838|NCT02880956|144261911|SUPERIORITY||Effect size/pooled SD|-0.06|STANDARD_DEVIATION|0.88|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
72375839|NCT02880956|144261911|SUPERIORITY||LS Mean of Difference|0.02|STANDARD_ERROR_OF_MEAN|0.112||0.887|TWO_SIDED|95.0|-0.204|0.236||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 72||0.236|-0.204|0.887
72375840|NCT02880956|144261911|SUPERIORITY||Effect size/pooled SD|-0.02|STANDARD_DEVIATION|0.84|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
72375841|NCT02880956|144261911|SUPERIORITY||LS Mean of Difference|0.27|STANDARD_ERROR_OF_MEAN|0.111||0.016|TWO_SIDED|95.0|0.051|0.486||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 72||0.486|0.051|0.016
72375842|NCT02880956|144261911|SUPERIORITY||Effect size/pooled SD|-0.33|STANDARD_DEVIATION|0.8|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
72375843|NCT02880956|144261911|SUPERIORITY||LS Mean of Difference|0.12|STANDARD_ERROR_OF_MEAN|0.112||0.272|TWO_SIDED|95.0|-0.097|0.342||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 72||0.342|-0.097|0.272
72375844|NCT02880956|144261911|SUPERIORITY||Effect size/pooled SD|-0.15|STANDARD_DEVIATION|0.81|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
72375845|NCT02880956|144261911|SUPERIORITY||LS Mean of Difference|0.06|STANDARD_ERROR_OF_MEAN|0.145||0.671|TWO_SIDED|95.0|-0.223|0.347||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 96||0.347|-0.223|0.671
72375846|NCT02880956|144261911|SUPERIORITY||Effect size/pooled SD|-0.07|STANDARD_DEVIATION|0.88|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
72375847|NCT02880956|144261911|SUPERIORITY||LS Mean of Difference|0.1|STANDARD_ERROR_OF_MEAN|0.143||0.493|TWO_SIDED|95.0|-0.183|0.378||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 96||0.378|-0.183|0.493
72375848|NCT02880956|144261911|SUPERIORITY||Effect size/pooled SD|-0.11|STANDARD_DEVIATION|0.92|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
72375849|NCT02880956|144261911|SUPERIORITY||LS Mean of Difference|0.1|STANDARD_ERROR_OF_MEAN|0.147||0.501|TWO_SIDED|95.0|-0.19|0.387||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 96||0.387|-0.190|0.501
72375850|NCT02880956|144261911|SUPERIORITY||Effect size/pooled SD|-0.1|STANDARD_DEVIATION|0.98|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
72375851|NCT02880956|144261912|SUPERIORITY||LS Mean of Difference|0.06|STANDARD_ERROR_OF_MEAN|0.188||0.742|TWO_SIDED|95.0|-0.307|0.431||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 24||0.431|-0.307|0.742
72375852|NCT02880956|144261912|SUPERIORITY||Effect size/pooled SD|-0.04|STANDARD_DEVIATION|1.5|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
72375853|NCT02880956|144261912|SUPERIORITY||LS Mean of Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.185||0.431|TWO_SIDED|95.0|-0.511|0.218||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 24||0.218|-0.511|0.431
72375854|NCT02880956|144261912|SUPERIORITY||Effect size/pooled SD|0.1|STANDARD_DEVIATION|1.5|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
72375855|NCT02880956|144261912|SUPERIORITY||LS Mean of Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.19||0.29|TWO_SIDED|95.0|-0.574|0.172||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 24||0.172|-0.574|0.290
72433556|NCT03722446|144380271|SUPERIORITY|||||||1|||||||Chi-squared|||||||1.0000
72375856|NCT02880956|144261912|SUPERIORITY||effect size|0.13|STANDARD_DEVIATION|1.51|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
72375857|NCT02880956|144261912|SUPERIORITY||LS Mean of Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.191||0.541|TWO_SIDED|95.0|-0.492|0.258||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 48||0.258|-0.492|0.541
72375858|NCT02880956|144261912|SUPERIORITY||Effect size/pooled SD|0.08|STANDARD_DEVIATION|1.55|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
72375859|NCT02880956|144261912|SUPERIORITY||LS Mean of Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.186||0.617|TWO_SIDED|95.0|-0.459|0.272||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 48||0.272|-0.459|0.617
72375860|NCT02880956|144261912|SUPERIORITY||Effect size/pooled SD|0.06|STANDARD_DEVIATION|1.49|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
72375861|NCT02880956|144261912|SUPERIORITY||LS Mean of Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.191||0.457|TWO_SIDED|95.0|-0.517|0.233||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 48||0.233|-0.517|0.457
72375862|NCT02880956|144261912|SUPERIORITY||Effect size/pooled SD|0.09|STANDARD_DEVIATION|1.5|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
72375863|NCT02880956|144261912|SUPERIORITY||LS Mean of Difference|0.22|STANDARD_ERROR_OF_MEAN|0.188||0.245|TWO_SIDED|95.0|-0.151|0.59||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 72||0.590|-0.151|0.245
72555921|NCT01075282|144643214|SUPERIORITY_OR_OTHER||LS Mean Difference|3.24|||<|0.001|TWO_SIDED|95.0|2.59|3.89||Treatment comparison at 78 weeks.|ANCOVA|||||3.89|2.59|<0.001
72375864|NCT02880956|144261912|SUPERIORITY||Effect size/pooled SD|-0.15|STANDARD_DEVIATION|1.49|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
72375865|NCT02880956|144261912|SUPERIORITY||LS Mean of Difference|0.13|STANDARD_ERROR_OF_MEAN|0.187||0.491|TWO_SIDED|95.0|-0.238|0.496||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 72||0.496|-0.238|0.491
72375866|NCT02880956|144261912|SUPERIORITY||Effect size/pooled SD|-0.08|STANDARD_DEVIATION|1.6|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
72375867|NCT02880956|144261912|SUPERIORITY||LS Mean of Difference|0.28|STANDARD_ERROR_OF_MEAN|0.188||0.132|TWO_SIDED|95.0|-0.085|0.652||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 72||0.652|-0.085|0.132
72375868|NCT02880956|144261912|SUPERIORITY||Effect size/pooled SD|-0.18|STANDARD_DEVIATION|1.58|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
72375869|NCT02880956|144261912|SUPERIORITY||LS Mean of Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.19||0.751|TWO_SIDED|95.0|-0.434|0.313||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 96||0.313|-0.434|0.751
72375870|NCT02880956|144261912|SUPERIORITY||Effect size/pooled SD|0.04|STANDARD_DEVIATION|1.53|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
72375871|NCT02880956|144261912|SUPERIORITY||LS Mean of Difference|-0.27|STANDARD_ERROR_OF_MEAN|0.188||0.157|TWO_SIDED|95.0|-0.635|0.103||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 96||0.103|-0.635|0.157
72375872|NCT02880956|144261912|SUPERIORITY||Effect size/pooled SD|0.16|STANDARD_DEVIATION|1.63|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
72375873|NCT02880956|144261912|SUPERIORITY||LS Mean of Difference|-0.21|STANDARD_ERROR_OF_MEAN|0.192||0.283|TWO_SIDED|95.0|-0.585|0.172||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 96||0.172|-0.585|0.283
72375874|NCT02880956|144261912|SUPERIORITY||Effect size/pooled SD|0.14|STANDARD_DEVIATION|1.44|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
72433557|NCT03722446|144380272|SUPERIORITY||||||<|0.0001|||||||t-test, 1 sided|||||||<0.0001
72433558|NCT05273801|144380281|SUPERIORITY|||||||0.73|||||||t-test, 2 sided|||How frequently clinician ask about RPE/HR during session||||0.73
72433559|NCT05273801|144380281|SUPERIORITY|||||||0.05|||||||t-test, 2 sided|||How frequently education provided regarding HR/RPE during session||||0.05
72433560|NCT05273801|144380281|SUPERIORITY|||||||0.007|||||||t-test, 2 sided|||How frequently HR/RPE target is mentioned in session||||0.007
72433561|NCT05273801|144380281|SUPERIORITY|||||||0.005|||||||t-test, 2 sided|||How frequently clinician modifies session/task to reach HR/RPE target||||0.005
72433562|NCT05273801|144380281|SUPERIORITY|||||||1e-05|||||||t-test, 2 sided|||How frequently clinicians monitor HR/RPE during session||||0.00001
72375875|NCT02880956|144261913|SUPERIORITY||LS Mean of Difference|0.07|STANDARD_ERROR_OF_MEAN|0.08||0.363|TWO_SIDED|95.0|-0.085|0.231||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 24||0.231|-0.085|0.363
72375876|NCT02880956|144261913|SUPERIORITY||Effect size/pooled SD|-0.11|STANDARD_DEVIATION|0.66|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
72375877|NCT02880956|144261913|SUPERIORITY||LS Mean of Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.079||0.688|TWO_SIDED|95.0|-0.188|0.124||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 24||0.124|-0.188|0.688
72375878|NCT02880956|144261913|SUPERIORITY||Effect size/pooled SD|0.05|STANDARD_DEVIATION|0.64|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
72375879|NCT02880956|144261913|SUPERIORITY||LS Mean of Difference|0.12|STANDARD_ERROR_OF_MEAN|0.081||0.137|TWO_SIDED|95.0|-0.039|0.281||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 24||0.281|-0.039|0.137
72375880|NCT02880956|144261913|SUPERIORITY||Effect size/pooled SD|-0.18|STANDARD_DEVIATION|0.67|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
72375881|NCT02880956|144261913|SUPERIORITY||LS Mean of Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.107||0.408|TWO_SIDED|95.0|-0.3|0.122||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 48||0.122|-0.300|0.408
72375882|NCT02880956|144261913|SUPERIORITY||Effect size/pooled SD|0.1|STANDARD_DEVIATION|0.89|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
72375883|NCT02880956|144261913|SUPERIORITY||LS Mean of Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.104||0.249|TWO_SIDED|95.0|-0.325|0.085||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 48||0.085|-0.325|0.249
72375884|NCT02880956|144261913|SUPERIORITY||Effect size/pooled SD|0.15|STANDARD_DEVIATION|0.79|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
72375885|NCT02880956|144261913|SUPERIORITY||LS Mean of Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.107||0.616|TWO_SIDED|95.0|-0.265|0.157||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 48||0.157|-0.265|0.616
72375886|NCT02880956|144261913|SUPERIORITY||Effect size/pooled SD|0.06|STANDARD_DEVIATION|0.95|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
72375887|NCT02880956|144261913|SUPERIORITY||LS Mean of Difference|0.07|STANDARD_ERROR_OF_MEAN|0.119||0.555|TWO_SIDED|95.0|-0.163|0.304||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 72||0.304|-0.163|0.555
72375888|NCT02880956|144261913|SUPERIORITY||Effect size/pooled SD|-0.08|STANDARD_DEVIATION|0.83|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
72375889|NCT02880956|144261913|SUPERIORITY||LS Mean of Difference|0.03|STANDARD_ERROR_OF_MEAN|0.117||0.815|TWO_SIDED|95.0|-0.203|0.258||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||0.258|-0.203|0.815
72375890|NCT02880956|144261913|SUPERIORITY||Effect size/pooled SD|-0.03|STANDARD_DEVIATION|0.82|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
72375891|NCT02880956|144261913|SUPERIORITY||LS Mean of Difference|0.18|STANDARD_ERROR_OF_MEAN|0.119||0.138|TWO_SIDED|95.0|-0.057|0.409||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 72||0.409|-0.057|0.138
72375892|NCT02880956|144261913|SUPERIORITY||Effect size/pooled SD|-0.2|STANDARD_DEVIATION|0.89|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
72375893|NCT02880956|144261913|SUPERIORITY||LS Mean of Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.157||0.573|TWO_SIDED|95.0|-0.397|0.22||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 96||0.220|-0.397|0.573
72493920|NCT01978093|144516697|NON_INFERIORITY|Lower limit of the two-sided 97.5% CI on the GMC ratio (HibCY group over PedHIB group) for antibodies to S. pneumoniae serotype 18C is to be ≥0.5 (clinical limit for non-inferiority).|Adjusted GMC ratio|1.14|||||TWO_SIDED|97.5|0.97|1.35|||ANCOVA|GMC adjusted for BS sub cohorts;97.5% CI for adjusted GMC ratio(Ancova model:adjustment for BS sub cohorts-pooled variance)|To be able to conclude independently on primary objectives of Epoch 001 \& Epoch 002, a Bonferroni correction is used to test these primary objectives(1.25% one-sided for Epoch 001 and Epoch 002)|GMC ratios between HibCY and PedHIB groups for antibodies to S. pneumoniae serotype 18C concentrations one month after the fourth dose||1.35|0.97|
72375894|NCT02880956|144261913|SUPERIORITY||Effect size/pooled SD|0.09|STANDARD_DEVIATION|1.0|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
72375895|NCT02880956|144261913|SUPERIORITY||LS Mean of Difference|0.06|STANDARD_ERROR_OF_MEAN|0.154||0.689|TWO_SIDED|95.0|-0.241|0.365||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 96||0.365|-0.241|0.689
72375896|NCT02880956|144261913|SUPERIORITY||Effect size/pooled SD|-0.06|STANDARD_ERROR_OF_MEAN|1.11|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
72375897|NCT02880956|144261913|SUPERIORITY||LS Mean of Difference|0.07|STANDARD_ERROR_OF_MEAN|0.159||0.662|TWO_SIDED|95.0|-0.243|0.382||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 96||0.382|-0.243|0.662
72375898|NCT02880956|144261913|SUPERIORITY||Effect size/pooled SD|-0.06|STANDARD_DEVIATION|1.14|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
72375899|NCT02880956|144261914|SUPERIORITY||LS Mean of Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.184||0.291|TWO_SIDED|95.0|-0.555|0.167||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 24||0.167|-0.555|0.291
72375900|NCT02880956|144261914|SUPERIORITY||Effect size/pooled SD|0.13|STANDARD_DEVIATION|1.48|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
72375901|NCT02880956|144261914|SUPERIORITY||Effect size/pooled SD|-0.36|STANDARD_ERROR_OF_MEAN|0.182||0.051|TWO_SIDED|95.0|-0.713|0.001||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 24||0.001|-0.713|0.051
72375902|NCT02880956|144261914|SUPERIORITY||Effect size/pooled SD|0.23|STANDARD_DEVIATION|1.52|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
72375903|NCT02880956|144261914|SUPERIORITY||LS Mean of Difference|0.02|STANDARD_ERROR_OF_MEAN|0.185||0.921|TWO_SIDED|95.0|-0.346|0.383||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 24||0.383|-0.346|0.921
72375904|NCT02880956|144261914|SUPERIORITY||Effect size/pooled SD|-0.01|STANDARD_DEVIATION|1.53|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
72375905|NCT02880956|144261914|SUPERIORITY||LS Mean of Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.211||0.163|TWO_SIDED|95.0|-0.711|0.12||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 48||0.120|-0.711|0.163
72375906|NCT02880956|144261914|SUPERIORITY||Effect size/pooled SD|0.18|STANDARD_DEVIATION|1.67|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
72375907|NCT02880956|144261914|SUPERIORITY||LS Mean of Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.205||0.424|TWO_SIDED|95.0|-0.567|0.239||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 48||0.239|-0.567|0.424
72375908|NCT02880956|144261914|SUPERIORITY||Effect size/pooled SD|0.1|STANDARD_DEVIATION|1.61|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
72375909|NCT02880956|144261914|SUPERIORITY||LS Mean of Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.213||0.664|TWO_SIDED|95.0|-0.51|0.326||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 48||0.326|-0.510|0.664
72375910|NCT02880956|144261914|SUPERIORITY||Effect size/pooled SD|0.06|STANDARD_DEVIATION|1.67|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
72375911|NCT02880956|144261914|SUPERIORITY||LS Mean of Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.229||0.417|TWO_SIDED|95.0|-0.638|0.265||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 72||0.265|-0.638|0.417
72375912|NCT02880956|144261914|SUPERIORITY||Effect size/pooled SD|0.11|STANDARD_DEVIATION|1.71|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
72375913|NCT02880956|144261914|SUPERIORITY||LS Mean of Difference|-0.28|STANDARD_ERROR_OF_MEAN|0.227||0.217|TWO_SIDED|95.0|-0.727|0.166||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 72||0.166|-0.727|0.217
72375914|NCT02880956|144261914|SUPERIORITY||Effect size/pooled SD|0.17|STANDARD_DEVIATION|1.68|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
72375915|NCT02880956|144261914|SUPERIORITY||LS Mean of Difference|0.07|STANDARD_ERROR_OF_MEAN|0.231||0.753|TWO_SIDED|95.0|-0.381|0.526||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 72||0.526|-0.381|0.753
72504930|NCT02747043|144540922|OTHER|Risk difference (ABP 798 - Rituximab) and CIs were estimated by Wald asymptotic confidence limits, or exact confidence limits if n \< 25 for either treatment.|Risk Difference (RD)|4.0|||||TWO_SIDED|95.0|-8.3|16.3||||||Percentage risk difference for 'Any adverse event of interest'||16.3|-8.3|
72375916|NCT02880956|144261914|SUPERIORITY||Effect size/pooled SD|-0.04|STANDARD_DEVIATION|1.8|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
72375917|NCT02880956|144261914|SUPERIORITY||LS Mean of Difference|-0.23|STANDARD_ERROR_OF_MEAN|0.257||0.362|TWO_SIDED|95.0|-0.74|0.27||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 96||0.270|-0.740|0.362
72375918|NCT02880956|144261914|SUPERIORITY||Effect size/pooled SD|0.14|STANDARD_DEVIATION|1.62|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
72375919|NCT02880956|144261914|SUPERIORITY||LS Mean of Difference|0.07|STANDARD_ERROR_OF_MEAN|0.256||0.78|TWO_SIDED|95.0|-0.432|0.575||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 96||0.575|-0.432|0.780
72375920|NCT02880956|144261914|SUPERIORITY||Effect size/pooled SD|-0.04|STANDARD_DEVIATION|1.72|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
72375921|NCT02880956|144261914|SUPERIORITY||LS Mean of Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.263||0.974|TWO_SIDED|95.0|-0.526|0.509||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 96||0.509|-0.526|0.974
72375922|NCT02880956|144261914|SUPERIORITY||Effect size/pooled SD|0.01|STANDARD_DEVIATION|1.67|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
72504931|NCT02747043|144540922|OTHER|Risk difference (ABP 798 - Rituximab) and CIs were estimated by Wald asymptotic confidence limits, or exact confidence limits if n \< 25 for either treatment.|Risk Difference (RD)|0.1|||||TWO_SIDED|95.0|-12.1|12.3||||||Percentage risk difference for 'Infusion reactions including hypersensitivity'||12.3|-12.1|
72375923|NCT02880956|144261915|SUPERIORITY||LS Mean of Difference|0.0|STANDARD_ERROR_OF_MEAN|0.139||0.976|TWO_SIDED|95.0|-0.269|0.278||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 24||0.278|-0.269|0.976
72375924|NCT02880956|144261915|SUPERIORITY||Effect size/pooled SD|0.0|STANDARD_DEVIATION|1.1|||TWO_SIDED|||||||||Week 24||||
72375925|NCT02880956|144261915|SUPERIORITY||LS Mean of Difference|0.03|STANDARD_ERROR_OF_MEAN|0.137||0.85|TWO_SIDED|95.0|-0.244|0.296||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 24||0.296|-0.244|0.850
72375926|NCT02880956|144261915|SUPERIORITY||Effect size/pooled SD|-0.02|STANDARD_DEVIATION|1.13|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
72375927|NCT02880956|144261915|SUPERIORITY||LS Mean of Difference|0.0|STANDARD_ERROR_OF_MEAN|0.141||0.981|TWO_SIDED|95.0|-0.281|0.275||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 24||0.275|-0.281|0.981
72375928|NCT02880956|144261915|SUPERIORITY||Effect size/pooled SD|0.0|STANDARD_DEVIATION|1.05|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
72375929|NCT02880956|144261915|SUPERIORITY||LS Mean of Difference|0.0|STANDARD_ERROR_OF_MEAN|0.163||0.989|TWO_SIDED|95.0|-0.323|0.318||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 48||0.318|-0.323|0.989
72375930|NCT02880956|144261915|SUPERIORITY||Effect size/pooled SD|0.0|STANDARD_DEVIATION|1.32|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
72375931|NCT02880956|144261915|SUPERIORITY||LS Mean of Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.159||0.97|TWO_SIDED|95.0|-0.319|0.307||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 48||0.307|-0.319|0.970
72375932|NCT02880956|144261915|SUPERIORITY||effect size|0.0|STANDARD_DEVIATION|1.23|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
72375933|NCT02880956|144261915|SUPERIORITY||LS Mean of Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.164||0.215|TWO_SIDED|95.0|-0.526|0.119||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 48||0.119|-0.526|0.215
72375934|NCT02880956|144261915|SUPERIORITY||Effect size/pooled SD|0.17|STANDARD_DEVIATION|1.18|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
72375935|NCT02880956|144261915|SUPERIORITY||LS Mean of Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.163||0.665|TWO_SIDED|95.0|-0.392|0.25||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 72||0.250|-0.392|0.665
72555922|NCT01075282|144643214|SUPERIORITY_OR_OTHER||LS Mean Difference|2.82|||<|0.001|TWO_SIDED|95.0|2.17|3.46||Treatment comparison at 78 weeks.|ANCOVA|||||3.46|2.17|<0.001
72504932|NCT02747043|144540922|OTHER|Risk difference (ABP 798 - Rituximab) and CIs were estimated by Wald asymptotic confidence limits, or exact confidence limits if n \< 25 for either treatment.|Risk Difference (RD)|0.7|||||TWO_SIDED|95.0|-11.8|13.0||||||Percentage risk difference for 'Hematological reactions'||13.0|-11.8|
72504933|NCT02747043|144540922|OTHER|Risk difference (ABP 798 - Rituximab) and CIs were estimated by Wald asymptotic confidence limits, or exact confidence limits if n \< 25 for either treatment.|Risk Difference (RD)|0.8|||||TWO_SIDED|95.0|-11.8|13.2||||||Percentage risk difference in 'Cardiac disorders'||13.2|-11.8|
72504934|NCT02747043|144540922|OTHER|Risk difference (ABP 798 - Rituximab) and CIs were estimated by Wald asymptotic confidence limits, or exact confidence limits if n \< 25 for either treatment.|Risk Difference (RD)|1.6|||||TWO_SIDED|95.0|-10.9|14.0||||||Percentage risk difference in 'Serious infections'||14.0|-10.9|
72504935|NCT02747043|144540922|OTHER|Risk difference (ABP 798 - Rituximab) and CIs were estimated by Wald asymptotic confidence limits, or exact confidence limits if n \< 25 for either treatment.|Risk Difference (RD)|0.8|||||TWO_SIDED|95.0|-11.7|13.2||||||Percentage risk difference in 'Severe mucocutaneous reactions'||13.2|-11.7|
72504936|NCT01629667|144540933|SUPERIORITY_OR_OTHER||Least square mean difference|-1.77||||0.14|TWO_SIDED|95.0|-4.13|0.59|||ANCOVA|||||0.59|-4.13|0.140
72504937|NCT01629667|144540933|SUPERIORITY_OR_OTHER||Least square mean difference|-1.41||||0.234|TWO_SIDED|95.0|-3.73|0.91|||ANCOVA|||||0.91|-3.73|0.234
72504938|NCT01512368|144540961|SUPERIORITY_OR_OTHER||Slope|0.089|STANDARD_ERROR_OF_MEAN|0.063|<|0.001|TWO_SIDED|95.0|0.034|0.144||All reported p values are based on two-sided tests considering ≤0.05 as significant.|Regression, Linear|Adjusted for age, time of exercise, creatinine, waist to hip ratio, fat percentage, body mass index, mean rest heart rate, blood pressure.|Metabolic equivalents (METs) consumed were independently associated with the log of delta (final-basal) FGF21 levels.|"FGF21 was log transformed to approximate normality before analyses. Null hypothesis was Ho = Y1 (FGF21 level at baseline) = Y2 (FGF21 level after two weeks of exercising). Power calculation was 80% with 60 participants evaluated (one group). To evaluate the effect of exercise on clinical and biochemical parameters, we used the difference between final - basal levels (delta)."||0.144|0.034|<0.001
72504939|NCT00949650|144541032|SUPERIORITY_OR_OTHER|||||||0.0002||||||Two-sided p-value from log-rank test stratified by EGFR mutation group and race.|Log Rank|||||||0.0002
72504940|NCT00949650|144541032|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.576||||0.0002||95.0|0.426|0.778|||Regression, Cox|Cox Proportional Hazard (PH) regression stratified by epidermal growth factor receptor (EGFR) mutation group and race.|Afatinib 40 mg versus Pemetrexed/Cisplatin Chemotherapy.|||0.778|0.426|0.0002
72504941|NCT00949650|144541033|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.802|||<|0.0001||95.0|2.855|8.075|||Regression, Logistic|Logistic regression stratified for EGFR mutation group and race.|Afatinib 40 mg-Pemetrexed/Cisplatin Chemotherapy.|||8.075|2.855|<0.0001
72504942|NCT00949650|144541034|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.288||||0.0118||95.0|1.202|4.356|||Regression, Logistic|Logistic regression stratified for EGFR mutation group and race.|Afatinib 40 mg-Pemetrexed/Cisplatin Chemotherapy.|||4.356|1.202|0.0118
72504943|NCT00949650|144541035|SUPERIORITY_OR_OTHER|||||||0.7916||||||Two-sided p-value from log-rank test stratified by EGFR mutation group and race.|Log Rank|||||||0.7916
72504944|NCT00949650|144541035|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.88||||0.385||95.0|0.66|1.174|||Regression, Cox|Cox PH regression stratified by EGFR mutation group and race.|Afatinib 40 mg-Pemetrexed/Cisplatin Chemotherapy.|||1.174|0.660|0.3850
72504945|NCT00949650|144541036|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.82|||<|0.0001||95.0|-13.64|-5.99|||ANCOVA|Adjusted for baseline SoD, EGFR mutation group and race.|Afatinib 40 mg-Pemetrexed/Cisplatin Chemotherapy.|||-5.99|-13.64|<0.0001
72504946|NCT00949650|144541039|SUPERIORITY_OR_OTHER|||||||0.0062||||||Two-sided p-value from log-rank test stratified by EGFR mutation group and race.|Log Rank|||||||0.0062
72504947|NCT00949650|144541039|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.589||||0.2133||95.0|0.401|0.866|||Regression, Cox|Cox PH regression stratified by EGFR mutation group and race.|Afatinib 40 mg vs. Pemetrexed/Cisplatin Chemotherapy, if HR\<1 then favours Afatinib 40 mg.|||0.866|0.401|0.2133
72504948|NCT00949650|144541040|SUPERIORITY_OR_OTHER|||||||0.0129||||||Two-sided p-value from log-rank test stratified by EGFR mutation group and race.|Log Rank|||||||0.0129
72504949|NCT00949650|144541040|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.68||||0.0078||95.0|0.499|0.927|||Regression, Cox|Cox PH regression stratified by EGFR mutation group and race.|Afatinib 40 mg vs. Pemetrexed/Cisplatin Chemotherapy, if HR\<1 then favours Afatinib 40 mg.|||0.927|0.499|0.0078
72504950|NCT00949650|144541041|SUPERIORITY_OR_OTHER|||||||0.1882||||||Two-sided p-value from log-rank test stratified by EGFR mutation group and race.|Log Rank|||||||0.1882
72504951|NCT00949650|144541041|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.826||||0.0427||95.0|0.618|1.104|||Regression, Cox|Cox PH regression stratified by EGFR mutation group and race.|Afatinib 40 mg vs. Pemetrexed/Cisplatin Chemotherapy, if HR\<1 then favours Afatinib 40 mg.|||1.104|0.618|0.0427
72504952|NCT02708212|144541092|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||The two-sample t test will be used to compare the total doses of fentanyl and midazolam between the two study groups.||||<0.0001
72504953|NCT02708212|144541093|SUPERIORITY_OR_OTHER|||||||0.0012|||||||t-test, 2 sided|||The two-sample t test will be used to compare the total doses of midazolam between the two study groups.||||0.0012
72504954|NCT02708212|144541094|SUPERIORITY_OR_OTHER|||||||0.6967|||||||t-test, 2 sided|||||||0.6967
72504955|NCT05341466|144541095|SUPERIORITY||Mean Difference (Net)|0.528|STANDARD_ERROR_OF_MEAN|0.188||0.0098|||||||Mixed Models Analysis|||||||0.0098
72504956|NCT05341466|144541095|OTHER||Adjusted R-squared|0.418||||0.014|||||||Regression, Linear|||Linear regression analyses performed with the change in the MEP amplitude versus step length asymmetry.||||0.014
72504957|NCT05341466|144541095|OTHER||Adjusted R-squared|0.496||||0.006|||||||Regression, Linear|||Linear regression analyses performed with the change in the MEP amplitude versus step time asymmetry.||||0.006
72504958|NCT05341466|144541095|OTHER||Adjusted R-squared|0.666||||0.001|||||||Regression, Linear|||Linear regression analyses performed with the change in the MEP amplitude versus changes in net metabolic power.||||0.001
72504959|NCT05341466|144541096|SUPERIORITY||Median Difference (Net)|-0.0042|STANDARD_DEVIATION|0.0232||0.744|||||||ANOVA|||||||0.744
72375936|NCT02880956|144261915|SUPERIORITY||Effect size/pooled SD|0.06|STANDARD_DEVIATION|1.28|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
72375937|NCT02880956|144261915|SUPERIORITY||LS Mean of Difference|-0.31|STANDARD_ERROR_OF_MEAN|0.162||0.059|TWO_SIDED|95.0|-0.625|0.012||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 72||0.012|-0.625|0.059
72375938|NCT02880956|144261915|SUPERIORITY||Effect size/pooled SD|0.28|STANDARD_DEVIATION|1.11|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
72375939|NCT02880956|144261915|SUPERIORITY||LS Mean of Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.164||0.663|TWO_SIDED|95.0|-0.394|0.251||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 72||0.251|-0.394|0.663
72375940|NCT02880956|144261915|SUPERIORITY||Effect size/pooled SD|0.06|STANDARD_DEVIATION|1.27|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
72375941|NCT02880956|144261915|SUPERIORITY||LS Mean of Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.193||0.866|TWO_SIDED|95.0|-0.413|0.348||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 96||0.348|-0.413|0.866
72375942|NCT02880956|144261915|SUPERIORITY||Effect size/pooled SD|0.03|STANDARD_DEVIATION|1.23|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
72375943|NCT02880956|144261915|SUPERIORITY||LS Mean of Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.191||0.471|TWO_SIDED|95.0|-0.514|0.238||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 96||0.238|-0.514|0.471
72375944|NCT02880956|144261915|SUPERIORITY||Effect size/pooled SD|0.11|STANDARD_DEVIATION|1.24|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
72375945|NCT02880956|144261915|SUPERIORITY||LS Mean of Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.198||0.604|TWO_SIDED|95.0|-0.493|0.287||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 96||0.287|-0.493|0.604
72375946|NCT02880956|144261915|SUPERIORITY||Effect size/pooled SD|0.09|STANDARD_DEVIATION|1.21|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
72375947|NCT02880956|144261916|SUPERIORITY||LS Mean of Difference|0.07|STANDARD_ERROR_OF_MEAN|0.069||0.325|TWO_SIDED|95.0|-0.067|0.202||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 24||0.202|-0.067|0.325
72375948|NCT02880956|144261916|SUPERIORITY||Effect size/pooled SD|-0.12|STANDARD_DEVIATION|0.57|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
72375949|NCT02880956|144261916|SUPERIORITY||LS Mean of Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.067||0.51|TWO_SIDED|95.0|-0.177|0.088||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 24||0.088|-0.177|0.510
72375950|NCT02880956|144261916|SUPERIORITY||Effect size/pooled SD|0.1|STANDARD_DEVIATION|0.44|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
72375951|NCT02880956|144261916|SUPERIORITY||LS Mean of Difference|0.04|STANDARD_ERROR_OF_MEAN|0.069||0.601|TWO_SIDED|95.0|-0.1|0.172||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 24||0.172|-0.100|0.601
72375952|NCT02880956|144261916|SUPERIORITY||Effect size/pooled SD|-0.07|STANDARD_DEVIATION|0.49|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
72375953|NCT02880956|144261916|SUPERIORITY||LS Mean of Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.07||0.783|TWO_SIDED|95.0|-0.157|0.119||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 48||0.119|-0.157|0.783
72375954|NCT02880956|144261916|SUPERIORITY||Effect size/pooled SD|0.04|STANDARD_DEVIATION|0.52|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
72375955|NCT02880956|144261916|SUPERIORITY||LS Mean of Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.068||0.646|TWO_SIDED|95.0|-0.165|0.103||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 48||0.103|-0.165|0.646
72375956|NCT02880956|144261916|SUPERIORITY||Effect size/pooled SD|0.06|STANDARD_DEVIATION|0.48|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
72504960|NCT05341466|144541097|SUPERIORITY||Mean Difference (Net)|0.01|STANDARD_DEVIATION|0.0231||0.269|||||||ANOVA|||||||0.269
72504961|NCT05341466|144541098|SUPERIORITY||Median Difference (Net)|-0.4|STANDARD_DEVIATION|0.681||0.02|||||||ANOVA|||||||0.020
72375957|NCT02880956|144261916|SUPERIORITY||LS Mean of Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.07||0.209|TWO_SIDED|95.0|-0.226|0.05||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 48||0.050|-0.226|0.209
72375958|NCT02880956|144261916|SUPERIORITY||Effect size/pooled SD|0.18|STANDARD_DEVIATION|0.49|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
72375959|NCT02880956|144261916|SUPERIORITY||LS Mean of Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.091||0.454|TWO_SIDED|95.0|-0.246|0.11||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 72||0.110|-0.246|0.454
72375960|NCT02880956|144261916|SUPERIORITY||Effect size/pooled SD|0.1|STANDARD_DEVIATION|0.66|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
72375961|NCT02880956|144261916|SUPERIORITY||LS Mean of Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.089||0.141|TWO_SIDED|95.0|-0.306|0.043||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 72||0.043|-0.306|0.141
72375962|NCT02880956|144261916|SUPERIORITY||Effect size/pooled SD|0.23|STANDARD_DEVIATION|0.58|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
72375963|NCT02880956|144261916|SUPERIORITY||LS Mean of Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.09||0.107|TWO_SIDED|95.0|-0.323|0.031||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 72||0.031|-0.323|0.107
72375964|NCT02880956|144261916|SUPERIORITY||Effect size/pooled SD|0.24|STANDARD_DEVIATION|0.59|||TWO_SIDED|||||||||Week 72||||
72375965|NCT02880956|144261916|SUPERIORITY||LS Mean of Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.121||0.961|TWO_SIDED|95.0|-0.243|0.232||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 96||0.232|-0.243|0.961
72375966|NCT02880956|144261916|SUPERIORITY||Effect size/pooled SD|0.01|STANDARD_DEVIATION|0.79|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
72375967|NCT02880956|144261916|SUPERIORITY||LS Mean of Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.118||0.618|TWO_SIDED|95.0|-0.29|0.173||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 96||0.173|-0.290|0.618
72375968|NCT02880956|144261916|SUPERIORITY||Effect size/pooled SD|0.08|STANDARD_DEVIATION|0.77|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
72375969|NCT02880956|144261916|SUPERIORITY||LS Mean of Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.121||0.227|TWO_SIDED|95.0|-0.385|0.092||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 96||0.092|-0.385|0.227
72375970|NCT02880956|144261916|SUPERIORITY||Effect size/pooled SD|0.18|STANDARD_DEVIATION|0.79|||TWO_SIDED|||||||||Week 96||||
72375971|NCT02880956|144261917|SUPERIORITY||LS Mean of Difference|0.34|STANDARD_ERROR_OF_MEAN|0.18||0.056|TWO_SIDED|95.0|-0.009|0.697||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 24||0.697|-0.009|0.056
72375972|NCT02880956|144261917|SUPERIORITY||Effect size/pooled SD|-0.23|STANDARD_DEVIATION|1.49|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
72375973|NCT02880956|144261917|SUPERIORITY||LS Mean of Difference|0.0|STANDARD_ERROR_OF_MEAN|0.177||0.997|TWO_SIDED|95.0|-0.348|0.349||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 24||0.349|-0.348|0.997
72375974|NCT02880956|144261917|SUPERIORITY||Effect size/pooled SD|0.0|STANDARD_DEVIATION|1.34|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
72375975|NCT02880956|144261917|SUPERIORITY||LS Mean of Difference|0.41|STANDARD_ERROR_OF_MEAN|0.182||0.023|TWO_SIDED|95.0|0.056|0.772||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 24||0.772|0.056|0.023
72375976|NCT02880956|144261917|SUPERIORITY||Effect size/pooled SD|-0.3|STANDARD_DEVIATION|1.36|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
72375977|NCT02880956|144261917|SUPERIORITY||LS Mean of Difference|0.14|STANDARD_ERROR_OF_MEAN|0.212||0.502|TWO_SIDED|95.0|-0.274|0.558||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 48||0.558|-0.274|0.502
72375978|NCT02880956|144261917|SUPERIORITY||Effect size/pooled SD|-0.09|STANDARD_DEVIATION|1.58|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
72504962|NCT01065428|144541117|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||t-test, 2 sided|||||||<0.05
72504963|NCT01065428|144541118|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||t-test, 2 sided|||||||<0.05
72555923|NCT02709018|144643259|SUPERIORITY|||||||0.66|||||||Mixed Models Analysis|||||||0.66
72555924|NCT02709018|144643260|SUPERIORITY|||||||0.57|||||||Mixed Models Analysis|||||||0.57
72375979|NCT02880956|144261917|SUPERIORITY||LS Mean of Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.206||0.379|TWO_SIDED|95.0|-0.587|0.224||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 48||0.224|-0.587|0.379
72375980|NCT02880956|144261917|SUPERIORITY||Effect size/pooled SD|0.11|STANDARD_DEVIATION|1.61|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
72375981|NCT02880956|144261917|SUPERIORITY||LS Mean of Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.212||0.916|TWO_SIDED|95.0|-0.439|0.394||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 48||0.394|-0.439|0.916
72375982|NCT02880956|144261917|SUPERIORITY||Effect size/pooled SD|0.01|STANDARD_DEVIATION|1.57|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
72375983|NCT02880956|144261917|SUPERIORITY||LS Mean of Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.238||0.487|TWO_SIDED|95.0|-0.633|0.302||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 72||0.302|-0.633|0.487
72375984|NCT02880956|144261917|SUPERIORITY||Effect size/pooled SD|0.1|STANDARD_DEVIATION|1.7|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
72375985|NCT02880956|144261917|SUPERIORITY||LS Mean of Difference|0.01|STANDARD_ERROR_OF_MEAN|0.235||0.963|TWO_SIDED|95.0|-0.451|0.473||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 72||0.473|-0.451|0.963
72375986|NCT02880956|144261917|SUPERIORITY||Effect size/pooled SD|-0.01|STANDARD_DEVIATION|1.66|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
72375987|NCT02880956|144261917|SUPERIORITY||LS Mean of Difference|0.04|STANDARD_ERROR_OF_MEAN|0.238||0.856|TWO_SIDED|95.0|-0.424|0.51||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 72||0.510|-0.424|0.856
72375988|NCT02880956|144261917|SUPERIORITY||Effect size/pooled SD|-0.03|STANDARD_DEVIATION|1.71|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
72375989|NCT02880956|144261917|SUPERIORITY||LS Mean of Difference|0.2|STANDARD_ERROR_OF_MEAN|0.277||0.463|TWO_SIDED|95.0|-0.341|0.748||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 96||0.748|-0.341|0.463
72375990|NCT02880956|144261917|SUPERIORITY||Effect size/pooled SD|-0.11|STANDARD_DEVIATION|1.87|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
72375991|NCT02880956|144261917|SUPERIORITY||LS Mean of Difference|0.02|STANDARD_ERROR_OF_MEAN|0.273||0.943|TWO_SIDED|95.0|-0.518|0.557||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 96||0.557|-0.518|0.943
72375992|NCT02880956|144261917|SUPERIORITY||Effect size/pooled SD|-0.01|STANDARD_DEVIATION|1.93|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
72375993|NCT02880956|144261917|SUPERIORITY||LS Mean of Difference|0.74|STANDARD_ERROR_OF_MEAN|0.281||0.009|TWO_SIDED|95.0|0.191|1.295||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 96||1.295|0.191|0.009
72375994|NCT02880956|144261917|SUPERIORITY||Effect size/pooled SD|-0.38|STANDARD_DEVIATION|1.97|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
72375995|NCT02880956|144261918|SUPERIORITY||LS Mean of Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.138||0.325|TWO_SIDED|95.0|-0.408|0.136||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 24||0.136|-0.408|0.325
72375996|NCT02880956|144261918|SUPERIORITY||Effect size/pooled SD|0.13|STANDARD_DEVIATION|1.02|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
72555925|NCT01494532|144643270|SUPERIORITY_OR_OTHER|||||||0.814||95.0||||P-values were estimated from Mixed Model Repeated Measures (MMRM).|Mixed Models Analysis|||4mg/day vs Placebo||||0.814
72375997|NCT02880956|144261918|SUPERIORITY||LS Mean of Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.137||0.966|TWO_SIDED|95.0|-0.274|0.263||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 24||0.263|-0.274|0.966
72375998|NCT02880956|144261918|SUPERIORITY||Effect size/pooled SD|0.01|STANDARD_DEVIATION|1.11|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
72375999|NCT02880956|144261918|SUPERIORITY||LS Mean of Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.14||0.695|TWO_SIDED|95.0|-0.33|0.22||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 24||0.220|-0.330|0.695
72555926|NCT01494532|144643270|SUPERIORITY_OR_OTHER|||||||0.013||95.0||||P-values were estimated from Mixed Model Repeated Measures (MMRM).|Mixed Models Analysis|||8 mg/day vs Placebo||||0.013
72555927|NCT01494532|144643270|SUPERIORITY_OR_OTHER|||||||0.287||95.0||||P-values were estimated from Mixed Model Repeated Measures (MMRM).|Mixed Models Analysis|||12 mg/day vs Placebo||||0.287
72555928|NCT01494532|144643270|SUPERIORITY_OR_OTHER|||||||0.027||95.0||||P-values were estimated from Mixed Model Repeated Measures (MMRM).|Mixed Models Analysis|||16 mg/day vs Placebo||||0.027
72555929|NCT01494532|144643270|SUPERIORITY_OR_OTHER|||||||0.39||95.0||||P-values were estimated from Mixed Model Repeated Measures (MMRM).|Mixed Models Analysis|||24 mg/day vs Placebo||||0.390
72555930|NCT01494532|144643270|SUPERIORITY_OR_OTHER|||||||0.844||95.0||||P-values are from a nonparametric rank ANCOVA|ANCOVA|||4mg/day vs Placebo||||0.844
72555931|NCT01494532|144643270|SUPERIORITY_OR_OTHER|||||||0.03||95.0||||P-values are from a nonparametric rank ANCOVA|ANCOVA|||8 mg/day vs Placebo||||0.030
72555932|NCT01494532|144643270|SUPERIORITY_OR_OTHER|||||||0.437||95.0||||P-values are from a nonparametric rank ANCOVA|ANCOVA|||12 mg/day vs Placebo||||0.437
72555933|NCT01494532|144643270|SUPERIORITY_OR_OTHER|||||||0.034||95.0||||P-values are from a nonparametric rank ANCOVA|ANCOVA|||16 mg/day vs Placebo||||0.034
72555934|NCT01494532|144643270|SUPERIORITY_OR_OTHER|||||||0.808||95.0||||P-values are from a nonparametric rank ANCOVA|ANCOVA|||24 mg/day vs Placebo||||0.808
72555935|NCT01494532|144643271|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.123||||0.826|TWO_SIDED|95.0|0.398|3.166|||Generalized Estimating Equations model|||||3.166|0.398|0.826
72555936|NCT01494532|144643271|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.622||||0.233|TWO_SIDED|95.0|0.732|3.593|||Generalized Estimating Equations model|||||3.593|0.732|0.233
72555937|NCT01494532|144643271|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.953||||0.902|TWO_SIDED|95.0|0.439|2.065|||Generalized Estimating Equations model|||||2.065|0.439|0.902
72555938|NCT01494532|144643271|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.866||||0.127|TWO_SIDED|95.0|0.837|4.158|||Generalized Estimating Equations model|||||4.158|0.837|0.127
72555939|NCT01494532|144643271|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.362||||0.564|TWO_SIDED|95.0|0.477|3.888|||Generalized Estimating Equations model|||||3.888|0.477|0.564
72555940|NCT01494532|144643272|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.908||||0.861|TWO_SIDED|95.0|0.31|2.659|||Generalized Estimating Equations model|||||2.659|0.310|0.861
72555941|NCT01494532|144643272|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.608||||0.277|TWO_SIDED|95.0|0.684|3.782|||Generalized Estimating Equations model|||||3.782|0.684|0.277
72555942|NCT01494532|144643272|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.074||||0.869|TWO_SIDED|95.0|0.461|2.5|||Generalized Estimating Equations model|||||2.500|0.461|0.869
72555943|NCT01494532|144643272|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.916||||0.14|TWO_SIDED|95.0|0.808|4.545|||Generalized Estimating Equations model|||||4.545|0.808|0.140
72555944|NCT01494532|144643272|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.689||||0.362|TWO_SIDED|95.0|0.547|5.218|||Generalized Estimating Equations model|||||5.218|0.547|0.362
72555945|NCT01494532|144643273|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.723||||0.525|TWO_SIDED|95.0|0.266|1.965|||Generalized Estimating Equations model|||||1.965|0.266|0.525
72555946|NCT01494532|144643273|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.851||||0.13|TWO_SIDED|95.0|0.834|4.109|||Generalized Estimating Equations model|||||4.109|0.834|0.130
72555947|NCT01494532|144643273|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.996||||0.992|TWO_SIDED|95.0|0.444|2.232|||Generalized Estimating Equations model|||||2.232|0.444|0.992
72555948|NCT01494532|144643273|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.48||||0.329|TWO_SIDED|95.0|0.674|3.248|||Generalized Estimating Equations model|||||3.248|0.674|0.329
72555949|NCT01494532|144643273|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.907||||0.856|TWO_SIDED|95.0|0.315|2.61|||Generalized Estimating Equations model|||||2.610|0.315|0.856
72555950|NCT01494532|144643275|SUPERIORITY_OR_OTHER|||||||0.376|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.376
72555951|NCT01494532|144643275|SUPERIORITY_OR_OTHER|||||||0.036|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.036
72555952|NCT01494532|144643275|SUPERIORITY_OR_OTHER|||||||0.362|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.362
72555953|NCT01494532|144643275|SUPERIORITY_OR_OTHER|||||||0.089|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.089
72555954|NCT01494532|144643275|SUPERIORITY_OR_OTHER|||||||0.403|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.403
72555955|NCT01494532|144643276|SUPERIORITY_OR_OTHER|||||||0.419|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.419
72555956|NCT01494532|144643276|SUPERIORITY_OR_OTHER|||||||0.026|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.026
72555957|NCT01494532|144643276|SUPERIORITY_OR_OTHER|||||||0.23|TWO_SIDED|95.0|||||Mixed Models Analysis|||||||0.230
72555958|NCT01494532|144643276|SUPERIORITY_OR_OTHER|||||||0.033|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.033
72555959|NCT01494532|144643276|SUPERIORITY_OR_OTHER|||||||0.266|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.266
72555960|NCT01494532|144643277|SUPERIORITY_OR_OTHER|||||||0.073|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.073
72555961|NCT01494532|144643277|SUPERIORITY_OR_OTHER|||||||0.996|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.996
72555962|NCT01494532|144643277|SUPERIORITY_OR_OTHER|||||||0.791|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.791
72555963|NCT01494532|144643277|SUPERIORITY_OR_OTHER|||||||0.747|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.747
72555964|NCT01494532|144643277|SUPERIORITY_OR_OTHER|||||||0.6|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.600
72555965|NCT01494532|144643278|SUPERIORITY_OR_OTHER|||||||0.998|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.998
72555966|NCT01494532|144643278|SUPERIORITY_OR_OTHER|||||||0.017|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.017
72555967|NCT01494532|144643278|SUPERIORITY_OR_OTHER|||||||0.312|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.312
72555968|NCT01494532|144643278|SUPERIORITY_OR_OTHER|||||||0.008|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.008
72555969|NCT01494532|144643278|SUPERIORITY_OR_OTHER|||||||0.659|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.659
72555970|NCT01494532|144643279|SUPERIORITY_OR_OTHER|||||||0.337|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.337
72555971|NCT01494532|144643279|SUPERIORITY_OR_OTHER|||||||0.126|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.126
72376000|NCT02880956|144261918|SUPERIORITY||Effect size/pooled SD|0.05|STANDARD_DEVIATION|1.09|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
72376001|NCT02880956|144261918|SUPERIORITY||LS Mean of Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.145||0.662|TWO_SIDED|95.0|-0.348|0.221||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 48||0.221|-0.348|0.662
72376002|NCT02880956|144261918|SUPERIORITY||Effect size/pooled SD|0.06|STANDARD_DEVIATION|1.01|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
72376003|NCT02880956|144261918|SUPERIORITY||LS Mean of Difference|0.03|STANDARD_ERROR_OF_MEAN|0.141||0.849|TWO_SIDED|95.0|-0.25|0.304||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 48||0.304|-0.250|0.849
72376004|NCT02880956|144261918|SUPERIORITY||Effect size/pooled SD|-0.03|STANDARD_DEVIATION|1.08|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
72376005|NCT02880956|144261918|SUPERIORITY||LS Mean of Difference|0.0|STANDARD_ERROR_OF_MEAN|0.145||0.995|TWO_SIDED|95.0|-0.286|0.284||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 48||0.284|-0.286|0.995
72376006|NCT02880956|144261918|SUPERIORITY||Effect size/pooled SD|0.0|STANDARD_DEVIATION|0.96|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
72376007|NCT02880956|144261918|SUPERIORITY||LS Mean of Difference|0.06|STANDARD_ERROR_OF_MEAN|0.161||0.707|TWO_SIDED|95.0|-0.256|0.378||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 72||0.378|-0.256|0.707
72555972|NCT01494532|144643279|SUPERIORITY_OR_OTHER|||||||0.283|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.283
72555973|NCT01494532|144643279|SUPERIORITY_OR_OTHER|||||||0.148|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.148
72376008|NCT02880956|144261918|SUPERIORITY||Effect size/pooled SD|-0.05|STANDARD_DEVIATION|1.13|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
72376009|NCT02880956|144261918|SUPERIORITY||LS Mean of Difference|0.02|STANDARD_ERROR_OF_MEAN|0.159||0.901|TWO_SIDED|95.0|-0.294|0.333||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 72||0.333|-0.294|0.901
72555974|NCT01494532|144643279|SUPERIORITY_OR_OTHER|||||||0.581|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.581
72376010|NCT02880956|144261918|SUPERIORITY||Effect size/pooled SD|-0.02|STANDARD_DEVIATION|1.23|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
72376011|NCT02880956|144261918|SUPERIORITY||LS Mean of Difference|0.12|STANDARD_ERROR_OF_MEAN|0.161||0.451|TWO_SIDED|95.0|-0.195|0.439||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 72||0.439|-0.195|0.451
72376012|NCT02880956|144261918|SUPERIORITY||Effect size/pooled SD|-0.11|STANDARD_DEVIATION|1.13|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
72376013|NCT02880956|144261918|SUPERIORITY||LS Mean of Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.185||0.722|TWO_SIDED|95.0|-0.429|0.298||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 96||0.298|-0.429|0.722
72376014|NCT02880956|144261918|SUPERIORITY||Effect size/pooled SD|0.06|STANDARD_DEVIATION|1.13|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
72376015|NCT02880956|144261918|SUPERIORITY||LS Mean of Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.181||0.42|TWO_SIDED|95.0|-0.503|0.21||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 96||0.210|-0.503|0.420
72376016|NCT02880956|144261918|SUPERIORITY||Effect size/pooled SD|0.12|STANDARD_DEVIATION|1.21|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
72555975|NCT01494532|144643280|SUPERIORITY_OR_OTHER|||||||0.486|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.486
72555976|NCT01494532|144643280|SUPERIORITY_OR_OTHER|||||||0.026|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.026
72555977|NCT01494532|144643280|SUPERIORITY_OR_OTHER|||||||0.121|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.121
72555978|NCT01494532|144643280|SUPERIORITY_OR_OTHER|||||||0.081|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.081
72555979|NCT01494532|144643280|SUPERIORITY_OR_OTHER|||||||0.187|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.187
72555980|NCT01494532|144643281|SUPERIORITY_OR_OTHER|||||||0.134|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.134
72555981|NCT01494532|144643281|SUPERIORITY_OR_OTHER|||||||0.768|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.768
72555982|NCT01494532|144643281|SUPERIORITY_OR_OTHER|||||||0.859|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.859
72376017|NCT02880956|144261918|SUPERIORITY||LS Mean of Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.187||0.498|TWO_SIDED|95.0|-0.495|0.241||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 96||0.241|-0.495|0.498
72376018|NCT02880956|144261918|SUPERIORITY||Effect size/pooled SD|0.11|STANDARD_DEVIATION|1.2|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
72555983|NCT01494532|144643281|SUPERIORITY_OR_OTHER|||||||0.903|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.903
72555984|NCT01494532|144643281|SUPERIORITY_OR_OTHER|||||||0.47|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.470
72555985|NCT01494532|144643282|SUPERIORITY_OR_OTHER|||||||0.822|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.822
72555986|NCT01494532|144643282|SUPERIORITY_OR_OTHER|||||||0.025|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.025
72555987|NCT01494532|144643282|SUPERIORITY_OR_OTHER|||||||0.267|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.267
72555988|NCT01494532|144643282|SUPERIORITY_OR_OTHER|||||||0.039|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.039
72555989|NCT01494532|144643282|SUPERIORITY_OR_OTHER|||||||0.458|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.458
72555990|NCT01494532|144643283|SUPERIORITY_OR_OTHER|||||||0.734|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.734
72555991|NCT01494532|144643283|SUPERIORITY_OR_OTHER|||||||0.048|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.048
72555992|NCT01494532|144643283|SUPERIORITY_OR_OTHER|||||||0.443|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.443
72555993|NCT01494532|144643283|SUPERIORITY_OR_OTHER|||||||0.123|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.123
72555994|NCT01494532|144643283|SUPERIORITY_OR_OTHER|||||||0.641|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.641
72555995|NCT01494532|144643284|SUPERIORITY_OR_OTHER|||||||0.822|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.822
72555996|NCT01494532|144643284|SUPERIORITY_OR_OTHER|||||||0.025|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.025
72376019|NCT02880956|144261919|SUPERIORITY||LS Mean of Difference|0.0|STANDARD_ERROR_OF_MEAN|0.071||0.975|TWO_SIDED|95.0|-0.138|0.142||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 24||0.142|-0.138|0.975
72376020|NCT02880956|144261919|SUPERIORITY||Effect size/pooled SD|0.0|STANDARD_DEVIATION|0.45|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
72555997|NCT01494532|144643284|SUPERIORITY_OR_OTHER|||||||0.267|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.267
72555998|NCT01494532|144643284|SUPERIORITY_OR_OTHER|||||||0.039|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.039
72555999|NCT01494532|144643284|SUPERIORITY_OR_OTHER|||||||0.458|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.458
72556000|NCT01494532|144643285|SUPERIORITY_OR_OTHER|||||||0.814|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.814
72556001|NCT01494532|144643285|SUPERIORITY_OR_OTHER|||||||0.013|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.013
72556002|NCT01494532|144643285|SUPERIORITY_OR_OTHER|||||||0.287|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.287
72556003|NCT01494532|144643285|SUPERIORITY_OR_OTHER|||||||0.027|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.027
72556004|NCT01494532|144643285|SUPERIORITY_OR_OTHER|||||||0.39|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.390
72556005|NCT01494532|144643286|SUPERIORITY_OR_OTHER|||||||0.376|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.376
72556006|NCT01494532|144643286|SUPERIORITY_OR_OTHER|||||||0.036|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.036
72556007|NCT01494532|144643286|SUPERIORITY_OR_OTHER|||||||0.362|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.362
72556008|NCT01494532|144643286|SUPERIORITY_OR_OTHER|||||||0.089|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.089
72556009|NCT01494532|144643286|SUPERIORITY_OR_OTHER|||||||0.403|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.403
72556010|NCT01494532|144643287|SUPERIORITY_OR_OTHER|||||||0.419|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.419
72556011|NCT01494532|144643287|SUPERIORITY_OR_OTHER|||||||0.026|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.026
72556012|NCT01494532|144643287|SUPERIORITY_OR_OTHER|||||||0.23|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.230
72556013|NCT01494532|144643287|SUPERIORITY_OR_OTHER|||||||0.033|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.033
72556014|NCT01494532|144643287|SUPERIORITY_OR_OTHER|||||||0.266|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.266
72556015|NCT01494532|144643288|SUPERIORITY_OR_OTHER|||||||0.073|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.073
72556016|NCT01494532|144643288|SUPERIORITY_OR_OTHER|||||||0.996|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.996
72556017|NCT01494532|144643288|SUPERIORITY_OR_OTHER|||||||0.791|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.791
72556018|NCT01494532|144643288|SUPERIORITY_OR_OTHER|||||||0.747|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.747
72556019|NCT01494532|144643288|SUPERIORITY_OR_OTHER|||||||0.6|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.600
72556020|NCT01494532|144643289|SUPERIORITY_OR_OTHER|||||||0.007|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.007
72376021|NCT02880956|144261919|SUPERIORITY||LS Mean of Difference|0.12|STANDARD_ERROR_OF_MEAN|0.07||0.078|TWO_SIDED|95.0|-0.014|0.261||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 24||0.261|-0.014|0.078
72376022|NCT02880956|144261919|SUPERIORITY||Effect size/pooled SD|-0.19|STANDARD_DEVIATION|0.66|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
72376023|NCT02880956|144261919|SUPERIORITY||LS Mean of Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.072||0.514|TWO_SIDED|95.0|-0.188|0.094||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 24||0.094|-0.188|0.514
72556021|NCT01494532|144643289|SUPERIORITY_OR_OTHER|||||||0.014|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.014
72376024|NCT02880956|144261919|SUPERIORITY||Effect size/pooled SD|0.1|STANDARD_DEVIATION|0.47|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
72376025|NCT02880956|144261919|SUPERIORITY||LS Mean of Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.102||0.107|TWO_SIDED|95.0|-0.367|0.036||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 48||0.036|-0.367|0.107
72376026|NCT02880956|144261919|SUPERIORITY||Effect size/pooled SD|0.23|STANDARD_DEVIATION|0.73|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
72376027|NCT02880956|144261919|SUPERIORITY||LS Mean of Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.099||0.425|TWO_SIDED|95.0|-0.275|0.116||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 48||0.116|-0.275|0.425
72376028|NCT02880956|144261919|SUPERIORITY||Effect size/pooled SD|0.09|STANDARD_DEVIATION|0.85|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
72376029|NCT02880956|144261919|SUPERIORITY||LS Mean of Difference|-0.21|STANDARD_ERROR_OF_MEAN|0.102||0.039|TWO_SIDED|95.0|-0.413|-0.011||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 48||-0.011|-0.413|0.039
72376030|NCT02880956|144261919|SUPERIORITY||Effect size/pooled SD|0.28|STANDARD_DEVIATION|0.77|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
72376031|NCT02880956|144261919|SUPERIORITY||LS Mean of Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.131||0.729|TWO_SIDED|95.0|-0.302|0.212||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 72||0.212|-0.302|0.729
72376032|NCT02880956|144261919|SUPERIORITY||Effect size/pooled SD|0.06|STANDARD_DEVIATION|0.81|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
72376033|NCT02880956|144261919|SUPERIORITY||LS Mean of Difference|0.05|STANDARD_ERROR_OF_MEAN|0.128||0.671|TWO_SIDED|95.0|-0.198|0.307||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 72||0.307|-0.198|0.671
72376034|NCT02880956|144261919|SUPERIORITY||Effect size/pooled SD|-0.06|STANDARD_DEVIATION|0.94|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
72376035|NCT02880956|144261919|SUPERIORITY||LS Mean of Difference|0.02|STANDARD_ERROR_OF_MEAN|0.13||0.876|TWO_SIDED|95.0|-0.235|0.276||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 72||0.276|-0.235|0.876
72376036|NCT02880956|144261919|SUPERIORITY||Effect size/pooled SD|-0.02|STANDARD_DEVIATION|0.92|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
72376037|NCT02880956|144261919|SUPERIORITY||LS Mean of Difference|0.05|STANDARD_ERROR_OF_MEAN|0.159||0.763|TWO_SIDED|95.0|-0.266|0.362||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 96||0.362|-0.266|0.763
72376038|NCT02880956|144261919|SUPERIORITY||Effect size/pooled SD|-0.04|STANDARD_DEVIATION|1.11|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
72376039|NCT02880956|144261919|SUPERIORITY||LS Mean of Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.157||0.429|TWO_SIDED|95.0|-0.434|0.185||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 96||0.185|-0.434|0.429
72556022|NCT01494532|144643289|SUPERIORITY_OR_OTHER|||||||0.016|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.016
72556023|NCT01494532|144643289|SUPERIORITY_OR_OTHER|||||||0.005|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.005
72556024|NCT01494532|144643289|SUPERIORITY_OR_OTHER|||||||0.008|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.008
72556025|NCT01494532|144643290|SUPERIORITY_OR_OTHER|||||||0.047|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.047
72556026|NCT01494532|144643290|SUPERIORITY_OR_OTHER|||||||0.005|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.005
72556027|NCT01494532|144643290|SUPERIORITY_OR_OTHER|||||||0.172|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.172
72556028|NCT01494532|144643290|SUPERIORITY_OR_OTHER|||||||0.034|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.034
72556029|NCT01494532|144643290|SUPERIORITY_OR_OTHER|||||||0.039|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.039
72556030|NCT01494532|144643291|SUPERIORITY_OR_OTHER|||||||0.292|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.292
72556031|NCT01494532|144643291|SUPERIORITY_OR_OTHER|||||||0.068|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.068
72556032|NCT01494532|144643291|SUPERIORITY_OR_OTHER|||||||0.17|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.170
72556033|NCT01494532|144643291|SUPERIORITY_OR_OTHER|||||||0.003|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.003
72556034|NCT01494532|144643291|SUPERIORITY_OR_OTHER|||||||0.153|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.153
72556035|NCT01494532|144643292|SUPERIORITY_OR_OTHER|||||||0.409|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.409
72556036|NCT01494532|144643292|SUPERIORITY_OR_OTHER|||||||0.598|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.598
72556037|NCT01494532|144643292|SUPERIORITY_OR_OTHER|||||||0.992|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.992
72556038|NCT01494532|144643292|SUPERIORITY_OR_OTHER|||||||0.169|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.169
72556039|NCT01494532|144643292|SUPERIORITY_OR_OTHER|||||||0.348|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.348
72376040|NCT02880956|144261919|SUPERIORITY||Effect size/pooled SD|0.12|STANDARD_DEVIATION|1.01|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
72376041|NCT02880956|144261919|SUPERIORITY||LS Mean of Difference|0.06|STANDARD_ERROR_OF_MEAN|0.162||0.701|TWO_SIDED|95.0|-0.256|0.381||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 96||0.381|-0.256|0.701
72556040|NCT00772603|144643306|SUPERIORITY_OR_OTHER||Median Difference (Net)|-18.3|||=|0.003|TWO_SIDED|95.0|-30.4|-5.8||P values reported are not adjusted for multiple comparisons. To preserve the overall Type I error-rate at 0.050, a step-up Hochberg procedure was used for the pair-wise comparisons.|Wilcoxon (Mann-Whitney)|||A Wilcoxon rank-sum test was used to test the hypothesis of equal median reduction in PCH(T) from baseline between SPN-804 and placebo. The sample size of 120 patients per treatment arm provides over 95% power to detect a difference of 31% to 42% between placebo and 2400mg SPN-804 at a two-sided 0.025 level for an overall Type I error rate of 0.050.||-5.80|-30.40|=0.003
72556041|NCT00772603|144643306|SUPERIORITY_OR_OTHER||Median Difference (Net)|-10.3|||=|0.078|TWO_SIDED|95.0|-22.3|1.2||P values reported are not adjusted for multiple comparisons. To preserve the overall Type I error-rate at 0.050, a step-up Hochberg procedure was used for the pair-wise comparisons.|Wilcoxon (Mann-Whitney)|||A Wilcoxon rank-sum test was used to test the hypothesis of equal median reduction in PCH(T) from baseline between SPN-804 and placebo. The sample size of 120 patients per treatment arm provides over 95% power to detect a difference of 24% to 32% between placebo and 1200mg SPN-804 at a two-sided 0.025 level for an overall Type I error rate of 0.050.||1.20|-22.30|=0.078
72556042|NCT00772603|144643307|SUPERIORITY_OR_OTHER||Median Difference (Net)|-33.0|||=|0.003|TWO_SIDED|95.0|-33.0|-6.3||P values reported are not adjusted for multiple comparisons. To preserve the overall Type I error-rate at 0.050, a step-up Hochberg procedure was used for the pair-wise comparisons.|Wilcoxon (Mann-Whitney)|||A Wilcoxon rank-sum test was used to test the hypothesis of equal median reduction in PCH(M) from baseline between SPN-804 and placebo. The sample size of 120 patients per treatment arm provides over 95% power to detect a difference of 31% to 42% between placebo and 2400mg SPN-804 at a two-sided 0.025 level for an overall Type I error rate of 0.050.||-6.30|-33.00|=0.003
72556043|NCT00772603|144643307|SUPERIORITY_OR_OTHER||Median Difference (Net)|-3.3|||=|0.589|TWO_SIDED|95.0|-16.2|9.7||P values reported are not adjusted for multiple comparisons. To preserve the overall Type I error-rate at 0.050, a step-up Hochberg procedure was used for the pair-wise comparisons.|Wilcoxon (Mann-Whitney)|||A Wilcoxon rank-sum test was used to test the hypothesis of equal median reduction in PCH(M) from baseline between SPN-804 and placebo. The sample size of 120 patients per treatment arm provides over 95% power to detect a difference of 24% to 32% between placebo and 1200mg SPN-804 at a two-sided 0.025 level for an overall Type I error rate of 0.050.||9.70|-16.20|=0.589
72556044|NCT00772603|144643308|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.983|||=|0.018|TWO_SIDED|95.0|1.126|3.494|||Regression, Logistic|||The treatment response was analyzed using a logistic regression model with treatment group as a factor and country (or cluster), age, sex, and baseline seizure frequency per 28 days as explanatory variables.||3.494|1.126|=0.018
72556045|NCT00772603|144643308|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.67|||=|0.075||95.0|0.95|2.937|||Regression, Logistic|||The treatment response was analyzed using a logistic regression model with treatment group as a factor and country (or cluster), age, sex, and baseline seizure frequency per 28 days as explanatory variables.||2.937|0.950|=0.075
72556046|NCT00772603|144643309|SUPERIORITY_OR_OTHER||||||=|0.013||95.0|||||Fisher Exact|||Pairwise comparisons of OXC XR 2400mg/day vs. placebo seizure-free rates during the Treatment Phase were made by means of Fisher's exact test for the ITT population.||||=0.013
72556047|NCT00772603|144643309|SUPERIORITY_OR_OTHER||||||=|0.528||95.0|||||Fisher Exact|||Pairwise comparisons of OXC XR 1200mg/day vs. placebo seizure-free rates during the Treatment Phase were made by means of Fisher's exact test for the ITT population.||||=0.528
72556048|NCT00772603|144643310|SUPERIORITY_OR_OTHER||||||=|0.008||95.0|||||Fisher Exact|||Pairwise comparisons of OXC XR 2400mg/day vs. placebo seizure-free rates during the Maintenance Period were made by means of Fisher's exact test for the ITT population.||||=0.008
72556049|NCT00772603|144643310|SUPERIORITY_OR_OTHER||||||=|0.0546||95.0|||||Fisher Exact|||Pairwise comparisons of OXC XR 1200mg/day vs. placebo seizure-free rates during the Maintenance Period were made by means of Fisher's exact test for the ITT population.||||=0.0546
72376042|NCT02880956|144261919|SUPERIORITY||Effect size/pooled SD|-0.06|STANDARD_DEVIATION|1.02|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
72376043|NCT02880956|144261920|SUPERIORITY||LS Mean of Difference|0.01|STANDARD_ERROR_OF_MEAN|0.064||0.867|TWO_SIDED|95.0|-0.115|0.137||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 24||0.137|-0.115|0.867
72376044|NCT02880956|144261920|SUPERIORITY||Effect size/pooled SD|-0.02|STANDARD_DEVIATION|0.48|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
72376045|NCT02880956|144261920|SUPERIORITY||LS Mean of Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.063||0.898|TWO_SIDED|95.0|-0.132|0.116||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 24||0.116|-0.132|0.898
72376046|NCT02880956|144261920|SUPERIORITY||Effect size/pooled SD|0.02|STANDARD_DEVIATION|0.51|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
72376047|NCT02880956|144261920|SUPERIORITY||LS Mean of Difference|0.04|STANDARD_ERROR_OF_MEAN|0.065||0.537|TWO_SIDED|95.0|-0.088|0.168||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 24||0.168|-0.088|0.537
72376048|NCT02880956|144261920|SUPERIORITY||Effect size/pooled SD|-0.07|STANDARD_DEVIATION|0.54|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
72376049|NCT02880956|144261920|SUPERIORITY||LS Mean of Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.074||0.176|TWO_SIDED|95.0|-0.245|0.045||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 48||0.045|-0.245|0.176
72376050|NCT02880956|144261920|SUPERIORITY||Effect size/pooled SD|0.15|STANDARD_DEVIATION|0.65|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
72376051|NCT02880956|144261920|SUPERIORITY||LS Mean of Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.072||0.125|TWO_SIDED|95.0|-0.251|0.031||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 48||0.031|-0.251|0.125
72376052|NCT02880956|144261920|SUPERIORITY||Effect size/pooled SD|0.21|STANDARD_DEVIATION|0.53|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
72376053|NCT02880956|144261920|SUPERIORITY||LS Mean of Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.074||0.676|TWO_SIDED|95.0|-0.176|0.114||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||week 48||0.114|-0.176|0.676
72376054|NCT02880956|144261920|SUPERIORITY||Effect size/pooled SD|0.05|STANDARD_DEVIATION|0.61|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
72556050|NCT00836004|144643311|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, ANOVA (Analysis of Variance) will be performed on log-transformed AUC0-t, AUC0-inf and Cmax at the alpha level of 0.05.|Test/Ref Ratio of LS Means x 100|99.69||||||90.0|93.88|105.85|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||105.85|93.88|
72376055|NCT02880956|144261920|SUPERIORITY||LS Mean of Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.095||0.226|TWO_SIDED|95.0|-0.301|0.071||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 72||0.071|-0.301|0.226
72376056|NCT02880956|144261920|SUPERIORITY||Effect size/pooled SD|0.18|STANDARD_DEVIATION|0.62|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
72376057|NCT02880956|144261920|SUPERIORITY||LS Mean of Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.093||0.683|TWO_SIDED|95.0|-0.222|0.145||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||0.145|-0.222|0.683
72376058|NCT02880956|144261920|SUPERIORITY||Effect size/pooled SD|0.06|STANDARD_DEVIATION|0.63|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
72376059|NCT02880956|144261920|SUPERIORITY||LS Mean of Difference|0.02|STANDARD_ERROR_OF_MEAN|0.094||0.848|TWO_SIDED|95.0|-0.168|0.204||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||0.204|-0.168|0.848
72556051|NCT00836004|144643312|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, ANOVA (Analysis of Variance) will be performed on log-transformed AUC0-t, AUC0-inf and Cmax at the alpha level of 0.05.|Test/Ref Ratio of LS Means x 100|96.23||||||90.0|90.62|102.19|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||102.19|90.62|
72556052|NCT00836004|144643313|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, ANOVA (Analysis of Variance) will be performed on log-transformed AUC0-t, AUC0-inf and Cmax at the alpha level of 0.05.|Test/Ref Ratio of LS Means x 100|97.17||||||90.0|92.14|102.48|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||102.48|92.14|
72376060|NCT02880956|144261920|SUPERIORITY||Effect size/pooled SD|-0.03|STANDARD_DEVIATION|0.67|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
72376061|NCT02880956|144261920|SUPERIORITY||LS Mean of Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.126||0.656|TWO_SIDED|95.0|-0.305|0.192||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||0.192|-0.305|0.656
72376062|NCT02880956|144261920|SUPERIORITY||Effect size/pooled SD|0.07|STANDARD_DEVIATION|0.78|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
72376063|NCT02880956|144261920|SUPERIORITY||LS Mean of Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.124||0.777|TWO_SIDED|95.0|-0.279|0.209||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||0.209|-0.279|0.777
72376064|NCT02880956|144261920|SUPERIORITY||Effect size/pooled SD|0.04|STANDARD_DEVIATION|0.88|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
72376065|NCT02880956|144261920|SUPERIORITY||LS Mean of Difference|0.15|STANDARD_ERROR_OF_MEAN|0.128||0.256|TWO_SIDED|95.0|-0.106|0.397||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||0.397|-0.106|0.256
72376066|NCT02880956|144261920|SUPERIORITY||Effect size/pooled SD|-0.16|STANDARD_DEVIATION|0.89|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
72376067|NCT02880956|144261921|SUPERIORITY||LS Mean of Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.101||0.479|TWO_SIDED|95.0|-0.269|0.126||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.126|-0.269|0.479
72376068|NCT02880956|144261921|SUPERIORITY||Effect size/pooled SD|0.09|STANDARD_DEVIATION|0.78|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
72376069|NCT02880956|144261921|SUPERIORITY||LS Mean of Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.099||0.295|TWO_SIDED|95.0|-0.299|0.091||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.091|-0.299|0.295
72376070|NCT02880956|144261921|SUPERIORITY||Effect size/pooled SD|0.13|STANDARD_DEVIATION|0.77|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
72376071|NCT02880956|144261921|SUPERIORITY||LS Mean of Difference|0.01|STANDARD_ERROR_OF_MEAN|0.102||0.884|TWO_SIDED|95.0|-0.186|0.215||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.215|-0.186|0.884
72376072|NCT02880956|144261921|SUPERIORITY||Effect size/pooled SD|-0.02|STANDARD_DEVIATION|0.83|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
72556053|NCT02888756|144643332|SUPERIORITY|||||||0.14|||||||Mixed Models Analysis|||Analyzed for week 6, to provide statistical information for decision on execution of intracellular cytokine staining (ICS).||||0.14
72376073|NCT02880956|144261921|SUPERIORITY||LS Mean of Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.111||0.569|TWO_SIDED|95.0|-0.281|0.155||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||0.155|-0.281|0.569
72556054|NCT04590027|144643345|NON_INFERIORITY|power calculation was not recorded Definition of non inferiority: two point difference of pain score at the measurement times|||||<|0.05|||||||ANCOVA|To rule out confounders due to an age difference, the ANCOVA test was applied to compare the differences in pain scores age-unrelatedly.|||Fisher Yates Test to compare the requirement of resue medication|||<0.05
72376074|NCT02880956|144261921|SUPERIORITY||Effect size/pooled SD|0.08|STANDARD_DEVIATION|0.78|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
72376075|NCT02880956|144261921|SUPERIORITY||Effect size/pooled SD|-0.04|STANDARD_ERROR_OF_MEAN|0.108||0.702|TWO_SIDED|95.0|-0.254|0.171||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||0.171|-0.254|0.702
72376076|NCT02880956|144261921|SUPERIORITY||Effect size/pooled SD|0.05|STANDARD_DEVIATION|0.78|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
72376077|NCT02880956|144261921|SUPERIORITY||LS Mean of Difference|0.06|STANDARD_ERROR_OF_MEAN|0.111||0.566|TWO_SIDED|95.0|-0.155|0.283||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||0.283|-0.155|0.566
72376078|NCT02880956|144261921|SUPERIORITY||Effect size/pooled SD|-0.07|STANDARD_DEVIATION|0.91|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
72556055|NCT04590027|144643346|SUPERIORITY||||||<|0.05|||||||Chi-squared|||||||<0.05
72556056|NCT00075478|144643363|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.57||||0.09|TWO_SIDED|95.0|0.3|1.1|||Regression, Cox|||Reference arm is Arm 2.||1.1|0.3|.09
72556057|NCT00075478|144643364|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.67||||0.59|TWO_SIDED|95.0|0.1|3.0|||Regression, Cox|||||3.0|0.1|0.59
72376079|NCT02880956|144261921|SUPERIORITY||LS Mean of Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.133||0.141|TWO_SIDED|95.0|-0.458|0.065||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||0.065|-0.458|0.141
72376080|NCT02880956|144261921|SUPERIORITY||Effect size/pooled SD|0.22|STANDARD_DEVIATION|0.91|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
72376081|NCT02880956|144261921|SUPERIORITY||LS Mean of Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.131||0.834|TWO_SIDED|95.0|-0.285|0.23||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||0.230|-0.285|0.834
72376082|NCT02880956|144261921|SUPERIORITY||Effect size/pooled SD|0.03|STANDARD_DEVIATION|0.99|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
72376083|NCT02880956|144261921|SUPERIORITY||LS Mean of Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.133||0.724|TWO_SIDED|95.0|-0.309|0.215||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||0.215|-0.309|0.724
72376084|NCT02880956|144261921|SUPERIORITY||Effect size/pooled SD|0.05|STANDARD_DEVIATION|1.0|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
72376085|NCT02880956|144261921|SUPERIORITY||LS Mean of Difference|-0.23|STANDARD_ERROR_OF_MEAN|0.166||0.163|TWO_SIDED|95.0|-0.559|0.095||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||0.095|-0.559|0.163
72376086|NCT02880956|144261921|SUPERIORITY||Effect size/pooled SD|0.24|STANDARD_DEVIATION|0.98|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
72376087|NCT02880956|144261921|SUPERIORITY||LS Mean of Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.163||0.497|TWO_SIDED|95.0|-0.432|0.21||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||0.210|-0.432|0.497
72376088|NCT02880956|144261921|SUPERIORITY||effect size|0.1|STANDARD_DEVIATION|1.09|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
72376089|NCT02880956|144261921|SUPERIORITY||LS Mean of Difference|0.02|STANDARD_ERROR_OF_MEAN|0.168||0.919|TWO_SIDED|95.0|-0.314|0.349||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||0.349|-0.314|0.919
72376090|NCT02880956|144261921|SUPERIORITY||Effect size/pooled SD|-0.01|STANDARD_DEVIATION|1.17|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
72376091|NCT02880956|144261922|SUPERIORITY||LS Mean of Difference|-0.28|STANDARD_ERROR_OF_MEAN|0.352||0.423|TWO_SIDED|95.0|-0.974|0.409||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.409|-0.974|0.423
72376092|NCT02880956|144261922|SUPERIORITY||Effect size/pooled SD|0.09|STANDARD_DEVIATION|3.09|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
72376093|NCT02880956|144261922|SUPERIORITY||LS Mean of Difference|-0.73|STANDARD_ERROR_OF_MEAN|0.346||0.036|TWO_SIDED|95.0|-1.408|-0.047||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||-0.047|-1.408|0.036
72376094|NCT02880956|144261922|SUPERIORITY||Effect size/pooled SD|0.25|STANDARD_DEVIATION|2.96|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
72376095|NCT02880956|144261922|SUPERIORITY||LS Mean of Difference|-0.55|STANDARD_ERROR_OF_MEAN|0.355||0.121|TWO_SIDED|95.0|-1.25|0.147||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.147|-1.250|0.121
72376096|NCT02880956|144261922|SUPERIORITY||Effect size/pooled SD|0.18|STANDARD_DEVIATION|3.09|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
72376097|NCT02880956|144261922|SUPERIORITY||LS Mean of Difference|-0.43|STANDARD_ERROR_OF_MEAN|0.371||0.244|TWO_SIDED|95.0|-1.163|0.296||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||0.296|-1.163|0.244
72376098|NCT02880956|144261922|SUPERIORITY||Effect size/pooled SD|0.15|STANDARD_DEVIATION|2.88|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
72376099|NCT02880956|144261922|SUPERIORITY||LS Mean of Difference|-0.62|STANDARD_ERROR_OF_MEAN|0.36||0.085|TWO_SIDED|95.0|-1.33|0.086||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||0.086|-1.330|0.085
72376100|NCT02880956|144261922|SUPERIORITY||Effect size/pooled SD|0.21|STANDARD_DEVIATION|3.03|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
72376101|NCT02880956|144261922|SUPERIORITY||LS Mean of Difference|-0.55|STANDARD_ERROR_OF_MEAN|0.371||0.137|TWO_SIDED|95.0|-1.28|0.177||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||0.177|-1.280|0.137
72376102|NCT02880956|144261922|SUPERIORITY||Effect size/pooled SD|0.19|STANDARD_DEVIATION|2.85|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
72376103|NCT02880956|144261922|SUPERIORITY||LS Mean of Difference|0.4|STANDARD_ERROR_OF_MEAN|0.352||0.258|TWO_SIDED|95.0|-0.294|1.091||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||1.091|-0.294|0.258
72376104|NCT02880956|144261922|SUPERIORITY||Effect size/pooled SD|-0.14|STANDARD_DEVIATION|2.88|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
72376105|NCT02880956|144261922|SUPERIORITY||LS Mean of Difference|0.13|STANDARD_ERROR_OF_MEAN|0.348||0.711|TWO_SIDED|95.0|-0.555|0.814||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||0.814|-0.555|0.711
72376106|NCT02880956|144261922|SUPERIORITY||Effect size/pooled SD|-0.04|STANDARD_DEVIATION|3.05|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
72376107|NCT02880956|144261922|SUPERIORITY||LS Mean of Difference|0.24|STANDARD_ERROR_OF_MEAN|0.35||0.503|TWO_SIDED|95.0|-0.454|0.924||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||0.924|-0.454|0.503
72556058|NCT00075478|144643365|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.55||||0.06|TWO_SIDED|95.0|0.3|1.0|||Regression, Cox|||||1.0|0.3|0.06
72376108|NCT02880956|144261922|SUPERIORITY||Effect size/pooled SD|-0.08|STANDARD_DEVIATION|2.99|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
72376109|NCT02880956|144261922|SUPERIORITY||LS Mean of Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.404||0.978|TWO_SIDED|95.0|-0.806|0.784||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||0.784|-0.806|0.978
72376110|NCT02880956|144261922|SUPERIORITY||Effect size/pooled SD|0.0|STANDARD_DEVIATION|3.12|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
72376111|NCT02880956|144261922|SUPERIORITY||LS Mean of Difference|-0.45|STANDARD_ERROR_OF_MEAN|0.402||0.265|TWO_SIDED|95.0|-1.239|0.342||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||0.342|-1.239|0.265
72376112|NCT02880956|144261922|SUPERIORITY||Effect size/pooled SD|0.14|STANDARD_DEVIATION|3.15|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
72376113|NCT02880956|144261922|SUPERIORITY||LS Mean of Difference|0.11|STANDARD_ERROR_OF_MEAN|0.414||0.789|TWO_SIDED|95.0|-0.704|0.925||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||0.925|-0.704|0.789
72376114|NCT02880956|144261922|SUPERIORITY||Effect size/pooled SD|-0.04|STANDARD_DEVIATION|2.82|||TWO_SIDED|||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.||||
72376115|NCT02880956|144261923|SUPERIORITY||LS Mean of Difference|0.21|STANDARD_ERROR_OF_MEAN|0.6||0.72|TWO_SIDED|95.0|-0.965|1.395||The statistical model: FAQ change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||1.395|-0.965|0.720
72376116|NCT02880956|144261923|SUPERIORITY||Effect size/pooled SD|-0.05|STANDARD_DEVIATION|4.73|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
72376117|NCT02880956|144261923|SUPERIORITY||LS Mean of Difference|-0.44|STANDARD_ERROR_OF_MEAN|0.592||0.455|TWO_SIDED|95.0|-1.607|0.722||The statistical model: FAQ change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.722|-1.607|0.455
72376118|NCT02880956|144261923|SUPERIORITY||Effect size/pooled SD|0.1|STANDARD_DEVIATION|4.55|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
72376119|NCT02880956|144261923|SUPERIORITY||LS Mean of Difference|0.43|STANDARD_ERROR_OF_MEAN|0.605||0.473|TWO_SIDED|95.0|-0.755|1.625||The statistical model: FAQ change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||1.625|-0.755|0.473
72556059|NCT00075478|144643366|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.53||||0.09|TWO_SIDED|95.0|0.3|1.1|||Regression, Cox|||||1.1|0.3|0.09
72556060|NCT00075478|144643367|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.6||||0.16|TWO_SIDED|95.0|0.8|3.1|||Regression, Cox|||||3.1|0.8|0.16
72556061|NCT00075478|144643368|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.52||||0.14|TWO_SIDED|95.0|0.9|2.7|||Regression, Cox|||||2.7|0.9|0.14
72376120|NCT02880956|144261923|SUPERIORITY||Effect size/pooled SD|-0.1|STANDARD_DEVIATION|4.25|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
72376121|NCT02880956|144261923|SUPERIORITY||LS Mean of Difference|0.16|STANDARD_ERROR_OF_MEAN|0.686||0.813|TWO_SIDED|95.0|-1.187|1.512||The statistical model: FAQ change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||1.512|-1.187|0.813
72376122|NCT02880956|144261923|SUPERIORITY||Effect size/pooled SD|-0.03|STANDARD_DEVIATION|5.3|||TWO_SIDED|||||||||Week 48||||
72376123|NCT02880956|144261923|SUPERIORITY||LS Mean of Difference|-0.54|STANDARD_ERROR_OF_MEAN|0.672||0.421|TWO_SIDED|95.0|-1.863|0.78||The statistical model: FAQ change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||0.780|-1.863|0.421
72376124|NCT02880956|144261923|SUPERIORITY||Effect size/pooled SD|0.1|STANDARD_DEVIATION|5.51|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
72376125|NCT02880956|144261923|SUPERIORITY||LS Mean of Difference|0.21|STANDARD_ERROR_OF_MEAN|0.687||0.758|TWO_SIDED|95.0|-1.139|1.564||The statistical model: FAQ change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||1.564|-1.139|0.758
72376126|NCT02880956|144261923|SUPERIORITY||Effect size/pooled SD|-0.04|STANDARD_DEVIATION|5.18|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
72376127|NCT02880956|144261923|SUPERIORITY||LS Mean of Difference|-0.54|STANDARD_ERROR_OF_MEAN|0.815||0.511|TWO_SIDED|95.0|-2.14|1.066||The statistical model: FAQ change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||1.066|-2.140|0.511
72376128|NCT02880956|144261923|SUPERIORITY||Effect size/pooled SD|0.09|STANDARD_DEVIATION|6.19|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
72376129|NCT02880956|144261923|SUPERIORITY||LS Mean of Difference|-1.05|STANDARD_ERROR_OF_MEAN|0.801||0.192|TWO_SIDED|95.0|-2.623|0.527||The statistical model: FAQ change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||0.527|-2.623|0.192
72376130|NCT02880956|144261923|SUPERIORITY||Effect size/pooled SD|0.17|STANDARD_DEVIATION|6.16|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
72376131|NCT02880956|144261923|SUPERIORITY||LS Mean of Difference|0.69|STANDARD_ERROR_OF_MEAN|0.816||0.398|TWO_SIDED|95.0|-0.914|2.294||The statistical model: FAQ change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||2.294|-0.914|0.398
72376132|NCT02880956|144261923|SUPERIORITY||Effect size/pooled SD|-0.12|STANDARD_DEVIATION|5.92|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
72376133|NCT02880956|144261923|SUPERIORITY||LS Mean of Difference|0.97|STANDARD_ERROR_OF_MEAN|0.924||0.296|TWO_SIDED|95.0|-0.851|2.784||The statistical model: FAQ change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||2.784|-0.851|0.296
72556062|NCT00075478|144643370|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.56||||0.05|TWO_SIDED|95.0|0.3|1.0|||Regression, Cox|||||1.0|0.3|0.05
72376134|NCT02880956|144261923|SUPERIORITY||Effect size/pooled SD|-0.14|STANDARD_DEVIATION|6.74|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
72376135|NCT02880956|144261923|SUPERIORITY||LS Mean of Difference|-0.34|STANDARD_ERROR_OF_MEAN|0.907||0.706|TWO_SIDED|95.0|-2.126|1.442||The statistical model: FAQ change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||1.442|-2.126|0.706
72376136|NCT02880956|144261923|SUPERIORITY||Effect size/pooled SD|0.05|STANDARD_DEVIATION|6.49|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
72376137|NCT02880956|144261923|SUPERIORITY||LS Mean of Difference|1.79|STANDARD_ERROR_OF_MEAN|0.929||0.055|TWO_SIDED|95.0|-0.036|3.617||The statistical model: FAQ change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||3.617|-0.036|0.055
72376138|NCT02880956|144261923|SUPERIORITY||Effect size/pooled SD|-0.28|STANDARD_DEVIATION|6.45|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
72376139|NCT02880956|144261924|SUPERIORITY||LS Mean of Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.11||0.651|TWO_SIDED|95.0|-0.266|0.166||The statistical model: ADCS-CGIC-MCI change from baseline = treatment + site + visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||0.166|-0.266|0.651
72556063|NCT00462228|144643396|SUPERIORITY_OR_OTHER|||||||0.55||95.0||||6 week comparison, alpha = 0.05.|Sign test|||Null hypothesis: The change from baseline occurring with memantine is equal to the change from baseline occurring with placebo at 6 weeks for HVLT-R total recall learning scores.||||0.55
72376140|NCT02880956|144261924|SUPERIORITY||Effect size/pooled SD|0.06|STANDARD_DEVIATION|0.82|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
72376141|NCT02880956|144261924|SUPERIORITY||LS Mean of Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.107||0.32|TWO_SIDED|95.0|-0.318|0.104||The statistical model: ADCS-CGIC-MCI change from baseline = treatment + site + visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||0.104|-0.318|0.320
72376142|NCT02880956|144261924|SUPERIORITY||Effect size/pooled SD|0.13|STANDARD_DEVIATION|0.81|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
72376143|NCT02880956|144261924|SUPERIORITY||LS Mean of Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.11||0.757|TWO_SIDED|95.0|-0.25|0.182||The statistical model: ADCS-CGIC-MCI change from baseline = treatment + site + visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||0.182|-0.250|0.757
72376144|NCT02880956|144261924|SUPERIORITY||Effect size/pooled SD|0.04|STANDARD_DEVIATION|0.83|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
72376145|NCT02880956|144261924|SUPERIORITY||LS Mean of Difference|0.0|STANDARD_ERROR_OF_MEAN|0.121||0.984|TWO_SIDED|95.0|-0.241|0.236||The statistical model: ADCS-CGIC-MCI change from baseline = treatment + site + visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||0.236|-0.241|0.984
72376146|NCT02880956|144261924|SUPERIORITY||Effect size/pooled SD|0.0|STANDARD_DEVIATION|0.85|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
72376147|NCT02880956|144261924|SUPERIORITY||LS Mean of Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.118||0.595|TWO_SIDED|95.0|-0.296|0.17||The statistical model: ADCS-CGIC-MCI change from baseline = treatment + site + visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||0.170|-0.296|0.595
72376148|NCT02880956|144261924|SUPERIORITY||Effect size/pooled SD|0.07|STANDARD_DEVIATION|0.93|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
72376149|NCT02880956|144261924|SUPERIORITY||LS Mean of Difference|0.05|STANDARD_ERROR_OF_MEAN|0.122||0.67|TWO_SIDED|95.0|-0.187|0.291||The statistical model: ADCS-CGIC-MCI change from baseline = treatment + site + visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||0.291|-0.187|0.670
72376150|NCT02880956|144261924|SUPERIORITY||Effect size/pooled SD|-0.06|STANDARD_DEVIATION|0.91|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
72376151|NCT02880956|144261925|SUPERIORITY||LS Mean of Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.112||0.722|TWO_SIDED|95.0|-0.26|0.18||The statistical model: ADCS-CGIC-MCI change from baseline = treatment + site + visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||0.180|-0.260|0.722
72376152|NCT02880956|144261925|SUPERIORITY||Effect size/pooled SD|0.05|STANDARD_DEVIATION|0.86|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
72376153|NCT02880956|144261925|SUPERIORITY||LS Mean of Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.109||0.878|TWO_SIDED|95.0|-0.232|0.198||The statistical model: ADCS-CGIC-MCI change from baseline = treatment + site + visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||0.198|-0.232|0.878
72376154|NCT02880956|144261925|SUPERIORITY||Effect size/pooled SD|0.02|STANDARD_ERROR_OF_MEAN|0.8|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
72376155|NCT02880956|144261925|SUPERIORITY||LS Mean of Difference|0.07|STANDARD_ERROR_OF_MEAN|0.112||0.535|TWO_SIDED|95.0|-0.151|0.29||The statistical model: ADCS-CGIC-MCI change from baseline = treatment + site + visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||0.290|-0.151|0.535
72376156|NCT02880956|144261925|SUPERIORITY||Effect size/pooled SD|-0.09|STANDARD_DEVIATION|0.81|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
72376157|NCT02880956|144261925|SUPERIORITY||Effect size/pooled SD|-0.01|STANDARD_ERROR_OF_MEAN|0.129||0.916|TWO_SIDED|95.0|-0.266|0.239||The statistical model: ADCS-CGIC-MCI change from baseline = treatment + site + visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||0.239|-0.266|0.916
72376158|NCT02880956|144261925|SUPERIORITY||Effect size/pooled SD|0.01|STANDARD_DEVIATION|0.91|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
72376159|NCT02880956|144261925|SUPERIORITY||LS Mean of Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.126||0.511|TWO_SIDED|95.0|-0.33|0.165||The statistical model: ADCS-CGIC-MCI change from baseline = treatment + site + visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||0.165|-0.330|0.511
72376160|NCT02880956|144261925|SUPERIORITY||Effect size/pooled SD|0.08|STANDARD_DEVIATION|1.0|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
72376161|NCT02880956|144261925|SUPERIORITY||LS Mean of Difference|0.04|STANDARD_ERROR_OF_MEAN|0.129||0.771|TWO_SIDED|95.0|-0.217|0.292||The statistical model: ADCS-CGIC-MCI change from baseline = treatment + site + visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||0.292|-0.217|0.771
72376162|NCT02880956|144261925|SUPERIORITY||Effect size/pooled SD|-0.04|STANDARD_DEVIATION|0.94|||TWO_SIDED|||||||||Week 96||||
72376163|NCT02880956|144261926|SUPERIORITY||LS Mean of Difference|0.01|STANDARD_ERROR_OF_MEAN|0.086||0.903|TWO_SIDED|95.0|-0.159|0.18||The statistical model: ADCS-CGIC-MCI change from baseline = treatment + site + visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||0.180|-0.159|0.903
72376164|NCT02880956|144261926|SUPERIORITY||Effect size/pooled SD|-0.02|STANDARD_DEVIATION|0.63|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
72376165|NCT02880956|144261926|SUPERIORITY||LS Mean of Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.084||0.811|TWO_SIDED|95.0|-0.185|0.145||The statistical model: ADCS-CGIC-MCI change from baseline = treatment + site + visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||0.145|-0.185|0.811
72376166|NCT02880956|144261926|SUPERIORITY||Effect size/pooled SD|0.03|STANDARD_DEVIATION|0.61|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
72376167|NCT02880956|144261926|SUPERIORITY||LS Mean of Difference|0.02|STANDARD_ERROR_OF_MEAN|0.086||0.775|TWO_SIDED|95.0|-0.145|0.194||The statistical model: ADCS-CGIC-MCI change from baseline = treatment + site + visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||0.194|-0.145|0.775
72376168|NCT02880956|144261926|SUPERIORITY||Effect size/pooled SD|-0.04|STANDARD_DEVIATION|0.62|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
72376169|NCT02880956|144261926|SUPERIORITY||LS Mean of Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.11||0.273|TWO_SIDED|95.0|-0.337|0.096||The statistical model: ADCS-CGIC-MCI change from baseline = treatment + site + visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||0.096|-0.337|0.273
72376170|NCT02880956|144261926|SUPERIORITY||Effect size/pooled SD|0.17|STANDARD_DEVIATION|0.73|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
72376171|NCT02880956|144261926|SUPERIORITY||LS Mean of Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.108||0.74|TWO_SIDED|95.0|-0.248|0.176||The statistical model: ADCS-CGIC-MCI change from baseline = treatment + site + visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||0.176|-0.248|0.740
72376172|NCT02880956|144261926|SUPERIORITY||Effect size/pooled SD|0.05|STANDARD_DEVIATION|0.8|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
72376173|NCT02880956|144261926|SUPERIORITY||LS Mean of Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.111||0.567|TWO_SIDED|95.0|-0.282|0.155||The statistical model: ADCS-CGIC-MCI change from baseline = treatment + site + visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||0.155|-0.282|0.567
72376174|NCT02880956|144261926|SUPERIORITY||Effect size/pooled SD|0.08|STANDARD_DEVIATION|0.8|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
72376175|NCT02880956|144261927|SUPERIORITY||LS Mean of Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.099||0.931|TWO_SIDED|95.0|-0.204|0.187||The statistical model: ADCS-CGIC-MCI change from baseline = treatment + site + visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||0.187|-0.204|0.931
72376176|NCT02880956|144261927|SUPERIORITY||Effect size/pooled SD|0.01|STANDARD_DEVIATION|0.73|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
72376177|NCT02880956|144261927|SUPERIORITY||LS Mean of Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.097||0.187|TWO_SIDED|95.0|-0.32|0.063||The statistical model: ADCS-CGIC-MCI change from baseline = treatment + site + visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||0.063|-0.320|0.187
72376178|NCT02880956|144261927|SUPERIORITY||Effect size/pooled SD|0.16|STANDARD_DEVIATION|0.78|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
72376179|NCT02880956|144261927|SUPERIORITY||LS Mean of Difference|0.0|STANDARD_ERROR_OF_MEAN|0.1||0.961|TWO_SIDED|95.0|-0.191|0.201||The statistical model: ADCS-CGIC-MCI change from baseline = treatment + site + visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||0.201|-0.191|0.961
72376180|NCT02880956|144261927|SUPERIORITY||Effect size/pooled SD|-0.01|STANDARD_DEVIATION|0.73|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
72376181|NCT02880956|144261927|SUPERIORITY||LS Mean of Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.124||0.894|TWO_SIDED|95.0|-0.26|0.227||The statistical model: ADCS-CGIC-MCI change from baseline = treatment + site + visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||0.227|-0.260|0.894
72376182|NCT02880956|144261927|SUPERIORITY||Effect size/pooled SD|0.02|STANDARD_DEVIATION|0.87|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
72376183|NCT02880956|144261927|SUPERIORITY||LS Mean of Difference|0.01|STANDARD_ERROR_OF_MEAN|0.121||0.917|TWO_SIDED|95.0|-0.226|0.251||The statistical model: ADCS-CGIC-MCI change from baseline = treatment + site + visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||0.251|-0.226|0.917
72376184|NCT02880956|144261927|SUPERIORITY||Effect size/pooled SD|-0.01|STANDARD_DEVIATION|0.91|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
72376185|NCT02880956|144261927|SUPERIORITY||LS Mean of Difference|0.06|STANDARD_ERROR_OF_MEAN|0.124||0.639|TWO_SIDED|95.0|-0.186|0.303||The statistical model: ADCS-CGIC-MCI change from baseline = treatment + site + visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||0.303|-0.186|0.639
72376186|NCT02880956|144261927|SUPERIORITY||Effect size/pooled SD|-0.06|STANDARD_DEVIATION|0.91|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
72376187|NCT02880956|144261928|SUPERIORITY||LS Mean of Difference|-1.57|STANDARD_ERROR_OF_MEAN|2.175||0.47|TWO_SIDED|95.0|-5.851|2.703||The statistical model: UPSA-Brief change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||2.703|-5.851|0.470
72376188|NCT02880956|144261928|SUPERIORITY||Effect size/pooled SD|-0.1|STANDARD_DEVIATION|15.44|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
72376189|NCT02880956|144261928|SUPERIORITY||LS Mean of Difference|0.36|STANDARD_ERROR_OF_MEAN|2.127||0.864|TWO_SIDED|95.0|-3.819|4.548||The statistical model: UPSA-Brief change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||4.548|-3.819|0.864
72376190|NCT02880956|144261928|SUPERIORITY||Effect size/pooled SD|0.02|STANDARD_DEVIATION|15.95|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
72376191|NCT02880956|144261928|SUPERIORITY||LS Mean of Difference|-4.49|STANDARD_ERROR_OF_MEAN|2.206||0.043|TWO_SIDED|95.0|-8.826|-0.15||The statistical model: UPSA-Brief change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||-0.150|-8.826|0.043
72376192|NCT02880956|144261928|SUPERIORITY||Effect size/pooled SD|-0.28|STANDARD_DEVIATION|16.24|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
72376193|NCT02880956|144261928|SUPERIORITY||LS Mean of Difference|0.61|STANDARD_ERROR_OF_MEAN|2.874||0.831|TWO_SIDED|95.0|-5.041|6.27||The statistical model: UPSA-Brief change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||6.270|-5.041|0.831
72376194|NCT02880956|144261928|SUPERIORITY||Effect size/pooled SD|0.03|STANDARD_DEVIATION|18.06|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
72376195|NCT02880956|144261928|SUPERIORITY||LS Mean of Difference|1.81|STANDARD_ERROR_OF_MEAN|2.843||0.525|TWO_SIDED|95.0|-3.784|7.404||The statistical model: UPSA-Brief change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||7.404|-3.784|0.525
72376196|NCT02880956|144261928|OTHER||Effect size/pooled SD|0.1|STANDARD_ERROR_OF_MEAN|18.47|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
72376197|NCT02880956|144261928|SUPERIORITY||LS Mean of Difference|-1.49|STANDARD_ERROR_OF_MEAN|2.921||0.61|TWO_SIDED|95.0|-7.239|4.255||The statistical model: UPSA-Brief change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||4.255|-7.239|0.610
72376198|NCT02880956|144261928|SUPERIORITY||Effect size/pooled SD|-0.08|STANDARD_DEVIATION|19.53|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
72376199|NCT02880956|144261929|SUPERIORITY||LS Mean of Difference|-0.79|STANDARD_ERROR_OF_MEAN|1.02||0.438|TWO_SIDED|95.0|-2.798|1.214||The statistical model: ADCS-MCI-ADL-24 change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; var-covar structure = Unstructured.|repeated measures model|||Week 48||1.214|-2.798|0.438
72376200|NCT02880956|144261929|SUPERIORITY||Effect size/pooled SD|-0.1|STANDARD_DEVIATION|7.87|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
72376201|NCT02880956|144261929|SUPERIORITY||LS Mean of Difference|0.81|STANDARD_ERROR_OF_MEAN|1.005||0.419|TWO_SIDED|95.0|-1.164|2.788||The statistical model: ADCS-MCI-ADL-24 change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; var-covar structure = Unstructured.|repeated measures model|||Week 48||2.788|-1.164|0.419
72376202|NCT02880956|144261929|SUPERIORITY||Effect size/pooled SD|0.1|STANDARD_DEVIATION|7.91|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
72376203|NCT02880956|144261929|SUPERIORITY||LS Mean of Difference|0.07|STANDARD_ERROR_OF_MEAN|1.03||0.948|TWO_SIDED|95.0|-1.959|2.092||The statistical model: ADCS-MCI-ADL-24 change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; var-covar structure = Unstructured.|repeated measures model|||Week 48||2.092|-1.959|0.948
72376204|NCT02880956|144261929|SUPERIORITY||Effect size/pooled SD|0.01|STANDARD_DEVIATION|8.01|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
72376205|NCT02880956|144261929|SUPERIORITY||LS Mean of Difference|-1.04|STANDARD_ERROR_OF_MEAN|1.597||0.516|TWO_SIDED|95.0|-4.18|2.101||The statistical model: ADCS-MCI-ADL-24 change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; var-covar structure = Unstructured.|repeated measures model|||Week 96||2.101|-4.180|0.516
72376206|NCT02880956|144261929|SUPERIORITY||Effect size/pooled SD|-0.1|STANDARD_DEVIATION|10.87|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
72376207|NCT02880956|144261929|SUPERIORITY||LS Mean of Difference|0.06|STANDARD_ERROR_OF_MEAN|1.582||0.971|TWO_SIDED|95.0|-3.055|3.168||The statistical model: ADCS-MCI-ADL-24 change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; var-covar structure = Unstructured.|repeated measures model|||Week 96||3.168|-3.055|0.971
72376208|NCT02880956|144261929|SUPERIORITY||Effect size/pooled SD|0.01|STANDARD_DEVIATION|11.24|||TWO_SIDED|||||||||Week 96||||
72376209|NCT02880956|144261929|SUPERIORITY||LS Mean of Difference|-1.39|STANDARD_ERROR_OF_MEAN|1.621||0.392|TWO_SIDED|95.0|-4.577|1.8||The statistical model: ADCS-MCI-ADL-24 change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; var-covar structure = Unstructured.|repeated measures model|||Week 96||1.800|-4.577|0.392
72376210|NCT02880956|144261929|SUPERIORITY||Effect size/pooled SD|-0.13|STANDARD_DEVIATION|10.87|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
72376211|NCT02880956|144261930|SUPERIORITY||LS Mean of Difference|-1.31|STANDARD_ERROR_OF_MEAN|0.902||0.148|TWO_SIDED|95.0|-3.08|0.465||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.465|-3.080|0.148
72376212|NCT02880956|144261930|SUPERIORITY||Effect size/pooled SD|-0.19|STANDARD_DEVIATION|6.81|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
72376213|NCT02880956|144261930|SUPERIORITY||LS Mean of Difference|-1.52|STANDARD_ERROR_OF_MEAN|0.896||0.092|TWO_SIDED|95.0|-3.278|0.246||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.246|-3.278|0.092
72376214|NCT02880956|144261930|SUPERIORITY||Effect size/pooled SD|-0.21|STANDARD_DEVIATION|7.14|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
72376215|NCT02880956|144261930|SUPERIORITY||LS Mean of Difference|-1.65|STANDARD_ERROR_OF_MEAN|0.915||0.073|TWO_SIDED|95.0|-3.446|0.152||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.152|-3.446|0.073
72556064|NCT00462228|144643396|SUPERIORITY_OR_OTHER|||||||1||95.0||||12 week comparison, alpha = 0.05.|Sign test|||Null hypothesis:The change from baseline occurring with memantine is equal to the change from baseline occurring with placebo at 12 weeks for HVLT-R total recall learning scores.||||1.00
72376216|NCT02880956|144261930|SUPERIORITY||Effect size/pooled SD|-0.25|STANDARD_DEVIATION|6.55|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
72556065|NCT00462228|144643396|SUPERIORITY_OR_OTHER|||||||0.45||95.0||||6 week comparison, alpha = 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis: The change from baseline occurring with memantine is equal to the change from baseline occurring with placebo at 6 weeks for HVLT-R total recall learning scores.||||0.45
72376217|NCT02880956|144261930|SUPERIORITY||LS Mean of Difference|0.47|STANDARD_ERROR_OF_MEAN|1.081||0.662|TWO_SIDED|95.0|-1.652|2.599||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||2.599|-1.652|0.662
72376218|NCT02880956|144261930|SUPERIORITY||Effect size/pooled SD|0.06|STANDARD_DEVIATION|8.07|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
72376219|NCT02880956|144261930|SUPERIORITY||LS Mean of Difference|-0.01|STANDARD_ERROR_OF_MEAN|1.057||0.992|TWO_SIDED|95.0|-2.089|2.068||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||2.068|-2.089|0.992
72376220|NCT02880956|144261930|SUPERIORITY||Effect size/pooled SD|0.0|STANDARD_DEVIATION|8.38|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
72376221|NCT02880956|144261930|SUPERIORITY||LS Mean of Difference|-0.82|STANDARD_ERROR_OF_MEAN|1.088||0.451|TWO_SIDED|95.0|-2.961|1.32||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||1.320|-2.961|0.451
72376222|NCT02880956|144261930|SUPERIORITY||Effect size/pooled SD|-0.11|STANDARD_DEVIATION|7.72|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
72376223|NCT02880956|144261930|SUPERIORITY||LS Mean of Difference|-0.67|STANDARD_ERROR_OF_MEAN|1.227||0.583|TWO_SIDED|95.0|-3.088|1.739||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||1.739|-3.088|0.583
72376224|NCT02880956|144261930|SUPERIORITY||Effect size/pooled SD|-0.08|STANDARD_DEVIATION|8.67|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
72376225|NCT02880956|144261930|SUPERIORITY||LS Mean of Difference|-1.59|STANDARD_ERROR_OF_MEAN|1.213||0.191|TWO_SIDED|95.0|-3.975|0.795||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||0.795|-3.975|0.191
72376226|NCT02880956|144261930|SUPERIORITY||Effect size/pooled SD|-0.17|STANDARD_DEVIATION|9.37|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
72556066|NCT00462228|144643396|SUPERIORITY_OR_OTHER|||||||0.43||95.0||||12 week comparison, alpha = 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis:The change from baseline occurring with memantine is equal to the change from baseline occurring with placebo at 12 weeks for HVLT-R total recall learning scores.||||0.43
72556067|NCT00462228|144643397|SUPERIORITY_OR_OTHER|||||||0.23||95.0||||6 week comparison,alpha = 0.05.|Sign test|||Null hypothesis: The change from baseline occurring with memantine is equal to the change from baseline occurring with placebo at 6 weeks for HVLT-R delayed recall scores||||0.23
72376227|NCT02880956|144261930|SUPERIORITY||LS Mean of Difference|-1.11|STANDARD_ERROR_OF_MEAN|1.238||0.372|TWO_SIDED|95.0|-3.541|1.329|||repeated measures model|||Week 72||1.329|-3.541|0.372
72376228|NCT02880956|144261930|SUPERIORITY||Effect size/pooled SD|-0.12|STANDARD_DEVIATION|8.96|||TWO_SIDED|||||||||Week 72||||
72376229|NCT02880956|144261930|SUPERIORITY||LS Mean of Difference|-0.99|STANDARD_ERROR_OF_MEAN|1.303||0.447|TWO_SIDED|95.0|-3.553|1.571||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||1.571|-3.553|0.447
72376230|NCT02880956|144261930|SUPERIORITY||Effect size/pooled SD|-0.11|STANDARD_DEVIATION|9.35|||TWO_SIDED|||||||||Week 96||||
72376231|NCT02880956|144261930|SUPERIORITY||LS Mean of Difference|0.19|STANDARD_ERROR_OF_MEAN|1.285||0.881|TWO_SIDED|95.0|-2.334|2.719||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||2.719|-2.334|0.881
72376232|NCT02880956|144261930|SUPERIORITY||Effect size/pooled SD|0.02|STANDARD_DEVIATION|8.68|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
72376233|NCT02880956|144261930|SUPERIORITY||LS Mean of Difference|-0.25|STANDARD_ERROR_OF_MEAN|1.338||0.853|TWO_SIDED|95.0|-2.881|2.383||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||2.383|-2.881|0.853
72376234|NCT02880956|144261930|SUPERIORITY||Effect size/pooled SD|-0.03|STANDARD_DEVIATION|8.54|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
72376235|NCT02880956|144261931|SUPERIORITY||LS Mean of Difference|-0.9|STANDARD_ERROR_OF_MEAN|0.846||0.287|TWO_SIDED|95.0|-2.567|0.762||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.762|-2.567|0.287
72376236|NCT02880956|144261931|SUPERIORITY||Effect size/pooled SD|-0.13|STANDARD_DEVIATION|6.76|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
72376237|NCT02880956|144261931|SUPERIORITY||LS Mean of Difference|-1.01|STANDARD_ERROR_OF_MEAN|0.838||0.227|TWO_SIDED|95.0|-2.661|0.633||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.633|-2.661|0.227
72376238|NCT02880956|144261931|SUPERIORITY||Effect size/pooled SD|-0.15|STANDARD_DEVIATION|6.83|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
72556068|NCT00462228|144643397|SUPERIORITY_OR_OTHER|||||||0.022||95.0||||12 week comparison, alpha = 0.05.|Sign test|||Null hypothesis: The change from baseline occurring with memantine is equal to the change from baseline occurring with placebo at 12 weeks for HVLT-R delayed recall scores.||||0.022
72376239|NCT02880956|144261931|SUPERIORITY||LS Mean of Difference|-1.01|STANDARD_ERROR_OF_MEAN|0.859||0.241|TWO_SIDED|95.0|-2.698|0.681||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.681|-2.698|0.241
72376240|NCT02880956|144261931|SUPERIORITY||Effect size/pooled SD|-0.16|STANDARD_DEVIATION|6.22|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
72376241|NCT02880956|144261931|SUPERIORITY||LS Mean of Difference|0.81|STANDARD_ERROR_OF_MEAN|0.958||0.397|TWO_SIDED|95.0|-1.073|2.696||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||2.696|-1.073|0.397
72376242|NCT02880956|144261931|SUPERIORITY||Effect size/pooled SD|0.11|STANDARD_DEVIATION|7.45|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
72376243|NCT02880956|144261931|SUPERIORITY||LS Mean of Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.936||0.671|TWO_SIDED|95.0|-2.239|1.443||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||1.443|-2.239|0.671
72376244|NCT02880956|144261931|SUPERIORITY||Effect size/pooled SD|-0.05|STANDARD_DEVIATION|7.59|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
72376245|NCT02880956|144261931|SUPERIORITY||LS Mean of Difference|-1.16|STANDARD_ERROR_OF_MEAN|0.964||0.231|TWO_SIDED|95.0|-3.052|0.738||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||0.738|-3.052|0.231
72376246|NCT02880956|144261931|SUPERIORITY||Effect size/pooled SD|-0.16|STANDARD_DEVIATION|7.25|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
72376247|NCT02880956|144261931|SUPERIORITY||LS Mean of Difference|2.47|STANDARD_ERROR_OF_MEAN|1.137||0.031|TWO_SIDED|95.0|0.23|4.701||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||4.701|0.230|0.031
72556069|NCT00462228|144643397|SUPERIORITY_OR_OTHER|||||||0.06||95.0||||6 week comparison, alpha = 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis: The change from baseline occurring with memantine is equal to the change from baseline occurring with placebo at 6 weeks for HVLT-R delayed recall scores.||||0.06
72556070|NCT00462228|144643397|SUPERIORITY_OR_OTHER|||||||0.027||95.0||||12 week comparison, alpha = 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis: The change from baseline occurring with memantine is equal to the change from baseline occurring with placebo at 12 weeks for HVLT-R delayed recall scores.||||0.027
72376248|NCT02880956|144261931|SUPERIORITY||Effect size/pooled SD|0.29|STANDARD_DEVIATION|8.65|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
72376249|NCT02880956|144261931|SUPERIORITY||LS Mean of Difference|0.68|STANDARD_ERROR_OF_MEAN|1.124||0.547|TWO_SIDED|95.0|-1.532|2.888||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||2.888|-1.532|0.547
72376250|NCT02880956|144261931|SUPERIORITY||Effect size/pooled SD|0.07|STANDARD_DEVIATION|9.1|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
72376251|NCT02880956|144261931|SUPERIORITY||LS Mean of Difference|0.73|STANDARD_ERROR_OF_MEAN|1.145||0.524|TWO_SIDED|95.0|-1.521|2.984||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||2.984|-1.521|0.524
72556071|NCT00462228|144643398|SUPERIORITY_OR_OTHER|||||||1||95.0||||6 week comparison, alpha = 0.05.|Sign test|||Null hypothesis: The change from baseline occurring with memantine is equal to the change from baseline occurring with placebo at 6 weeks for the Trail Making Test Part A.||||1.0
72556072|NCT00462228|144643398|SUPERIORITY_OR_OTHER|||||||0.55||95.0||||12 week comparison, alpha = 0.05.|Sign test|||Null hypothesis: The change from baseline occurring with memantine is equal to the change from baseline occurring with placebo at 12 weeks for the Trail Making Test Part A.||||0.55
72618337|NCT00286455|144767680|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.8||||0.388|TWO_SIDED|95.0|-9.3|3.6||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||3.6|-9.3|0.388
72618338|NCT05894564|144767681|SUPERIORITY|Posterior probability of efficacy (P(HR\>1))|Hazard Ratio (HR)|0.99|||||TWO_SIDED|95.0|0.88|1.1|||||The interval is a highest-density credible interval. Adjustment variables: randomization, age, sex, duration of symptoms prior to study drug, calendar time, vaccination status, geographic region, call center indicator, and baseline symptom severity.|||1.10|0.88|
72618339|NCT05894564|144767682|SUPERIORITY||Hazard Ratio (HR)|0.51|||||TWO_SIDED|95.0|0.05|5.65|||||Low event rate precluded covariate adjustment.|No hypothesis test or decision rule was evaluated.||5.65|0.05|
72618340|NCT05894564|144767685|SUPERIORITY|Posterior probability of efficacy (P(HR\<1))|Hazard Ratio (HR)|0.7|||||TWO_SIDED|95.0|0.31|1.28|||||The interval is a highest-density credible interval. Adjustment variables: randomization, age, sex, duration of symptoms prior to study drug, calendar time, vaccination status, geographic region, call center indicator, and baseline symptom severity.|No hypothesis test or decision rule was evaluated.||1.28|0.31|
72618341|NCT05894564|144767686|SUPERIORITY||Odds Ratio (OR)|1.16|||||TWO_SIDED|95.0|0.56|1.87|||||The interval is a highest-density credible interval. Adjustment variables: randomization, age, sex, duration of symptoms prior to study drug, calendar time, vaccination status, geographic region, call center indicator, and baseline symptom severity.|No hypothesis test or decision rule was evaluated.||1.87|0.56|
72618342|NCT05894564|144767687|SUPERIORITY||Odds Ratio (OR)|0.67|||||TWO_SIDED|95.0|0.25|1.16|||||The interval is a highest-density credible interval. Adjustment variables: randomization, age, sex, duration of symptoms prior to study drug, calendar time, vaccination status, geographic region, call center indicator, and baseline symptom severity.|No hypothesis test or decision rule was evaluated.||1.16|0.25|
72618343|NCT05894564|144767688|SUPERIORITY||Odds Ratio (OR)|0.95|||||TWO_SIDED|95.0|0.33|1.74|||||The interval is a highest-density credible interval. Adjustment variables: randomization, age, sex, duration of symptoms prior to study drug, calendar time, vaccination status, geographic region, call center indicator, and baseline symptom severity.|No hypothesis test or decision rule was evaluated.||1.74|0.33|
72376252|NCT02880956|144261931|SUPERIORITY||Effect size/pooled SD|0.09|STANDARD_DEVIATION|8.42|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
72376253|NCT02880956|144261931|SUPERIORITY||LS Mean of Difference|-0.83|STANDARD_ERROR_OF_MEAN|1.356||0.54|TWO_SIDED|95.0|-3.499|1.836||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||1.836|-3.499|0.540
72556073|NCT00462228|144643398|SUPERIORITY_OR_OTHER|||||||0.81||95.0||||6 week comparison, alpha = 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis: The change from baseline occurring with memantine is equal to the change from baseline occurring with placebo at 6 weeks for the Trail Making Test Part A.||||0.81
72556074|NCT00462228|144643398|SUPERIORITY_OR_OTHER|||||||0.57||95.0||||12 week comparison, alpha = 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis: The change from baseline occurring with memantine is equal to the change from baseline occurring with placebo at 12 weeks for the Trail Making Test Part A.||||0.57
72618344|NCT05894564|144767689|OTHER||Odds Ratio (OR)|0.93|||||TWO_SIDED|95.0|0.71|1.21|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 7||1.21|0.71|
72618345|NCT05894564|144767689|OTHER||Odds Ratio (OR)|0.89|||||TWO_SIDED|95.0|0.67|1.19|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 14||1.19|0.67|
72618346|NCT05894564|144767689|OTHER||Odds Ratio (OR)|0.85|||||TWO_SIDED|95.0|0.61|1.19|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 28||1.19|0.61|
72376254|NCT02880956|144261931|SUPERIORITY||Effect size/pooled SD|-0.08|STANDARD_DEVIATION|10.02|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
72376255|NCT02880956|144261931|SUPERIORITY||LS Mean of Difference|-0.58|STANDARD_ERROR_OF_MEAN|1.336||0.664|TWO_SIDED|95.0|-3.208|2.046||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||2.046|-3.208|0.664
72376256|NCT02880956|144261931|SUPERIORITY||Effect size/pooled SD|-0.06|STANDARD_DEVIATION|10.16|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
72376257|NCT02880956|144261931|SUPERIORITY||LS Mean of Difference|-1.19|STANDARD_ERROR_OF_MEAN|1.39||0.393|TWO_SIDED|95.0|-3.923|1.546||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||1.546|-3.923|0.393
72376258|NCT02880956|144261931|SUPERIORITY||Effect size/pooled SD|-0.13|STANDARD_DEVIATION|9.48|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
72376259|NCT02880956|144261932|SUPERIORITY||LS Mean of Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.262||0.946|TWO_SIDED|95.0|-0.534|0.498||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.498|-0.534|0.946
72376260|NCT02880956|144261932|SUPERIORITY||Effect size/pooled SD|-0.01|STANDARD_DEVIATION|2.13|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
72376261|NCT02880956|144261932|SUPERIORITY||LS Mean of Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.259||0.242|TWO_SIDED|95.0|-0.813|0.206||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.206|-0.813|0.242
72376262|NCT02880956|144261932|SUPERIORITY||Effect size/pooled SD|-0.14|STANDARD_DEVIATION|2.12|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
72376263|NCT02880956|144261932|SUPERIORITY||LS Mean of Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.266||0.541|TWO_SIDED|95.0|-0.685|0.36||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.360|-0.685|0.541
72376264|NCT02880956|144261932|SUPERIORITY||Effect size/pooled SD|-0.07|STANDARD_DEVIATION|2.3|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
72376265|NCT02880956|144261932|SUPERIORITY||LS Mean of Difference|0.11|STANDARD_ERROR_OF_MEAN|0.298||0.724|TWO_SIDED|95.0|-0.481|0.691||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||0.691|-0.481|0.724
72376266|NCT02880956|144261932|SUPERIORITY||Effect size/pooled SD|0.04|STANDARD_DEVIATION|2.36|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
72376267|NCT02880956|144261932|SUPERIORITY||LS Mean of Difference|0.34|STANDARD_ERROR_OF_MEAN|0.29||0.236|TWO_SIDED|95.0|-0.226|0.913||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||0.913|-0.226|0.236
72376268|NCT02880956|144261932|SUPERIORITY||Effect size/pooled SD|0.17|STANDARD_DEVIATION|2.03|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
72376269|NCT02880956|144261932|SUPERIORITY||LS Mean of Difference|0.11|STANDARD_ERROR_OF_MEAN|0.298||0.714|TWO_SIDED|95.0|-0.477|0.695||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||0.695|-0.477|0.714
72376270|NCT02880956|144261932|SUPERIORITY||Effect size/pooled SD|0.05|STANDARD_DEVIATION|2.11|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
72556075|NCT00462228|144643399|SUPERIORITY_OR_OTHER|||||||0.55||95.0||||6 week comparison, alpha = 0.05.|Sign test|||Null hypothesis: The change from baseline occurring with memantine is equal to the change from baseline occurring with placebo at 6 weeks for the Trail Making Test Part B.||||0.55
72376271|NCT02880956|144261932|SUPERIORITY||LS Mean of Difference|0.05|STANDARD_ERROR_OF_MEAN|0.277||0.86|TWO_SIDED|95.0|-0.496|0.593||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||0.593|-0.496|0.860
72376272|NCT02880956|144261932|SUPERIORITY||Effect size/pooled SD|0.02|STANDARD_DEVIATION|2.08|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
72376273|NCT02880956|144261932|SUPERIORITY||LS Mean of Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.274||0.476|TWO_SIDED|95.0|-0.733|0.343||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||0.343|-0.733|0.476
72376274|NCT02880956|144261932|SUPERIORITY||Effect size/pooled SD|-0.1|STANDARD_DEVIATION|2.0|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
72376275|NCT02880956|144261932|SUPERIORITY||LS Mean of Difference|0.15|STANDARD_ERROR_OF_MEAN|0.276||0.586|TWO_SIDED|95.0|-0.393|0.694||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||0.694|-0.393|0.586
72376276|NCT02880956|144261932|SUPERIORITY||Effect size/pooled SD|0.08|STANDARD_DEVIATION|1.97|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
72376277|NCT02880956|144261932|SUPERIORITY||LS Mean of Difference|0.27|STANDARD_ERROR_OF_MEAN|0.324||0.412|TWO_SIDED|95.0|-0.371|0.903||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||0.903|-0.371|0.412
72376278|NCT02880956|144261932|SUPERIORITY||Effect size/pooled SD|0.12|STANDARD_DEVIATION|2.2|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
72376279|NCT02880956|144261932|SUPERIORITY||LS Mean of Difference|0.24|STANDARD_ERROR_OF_MEAN|0.319||0.45|TWO_SIDED|95.0|-0.386|0.868||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||0.868|-0.386|0.450
72376280|NCT02880956|144261932|SUPERIORITY||Effect size/pooled SD|0.11|STANDARD_DEVIATION|2.23|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
72376281|NCT02880956|144261932|SUPERIORITY||LS Mean of Difference|0.17|STANDARD_ERROR_OF_MEAN|0.33||0.612|TWO_SIDED|95.0|-0.481|0.816||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||0.816|-0.481|0.612
72376282|NCT02880956|144261932|SUPERIORITY||Effect size/pooled SD|0.08|STANDARD_DEVIATION|2.1|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
72376283|NCT02880956|144261933|SUPERIORITY||LS Mean of Difference|-0.26|STANDARD_ERROR_OF_MEAN|0.405||0.52|TWO_SIDED|95.0|-1.058|0.535||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.535|-1.058|0.520
72376284|NCT02880956|144261933|SUPERIORITY||Effect size/pooled SD|-0.07|STANDARD_DEVIATION|3.52|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
72376285|NCT02880956|144261933|SUPERIORITY||LS Mean of Difference|-0.41|STANDARD_ERROR_OF_MEAN|0.401||0.303|TWO_SIDED|95.0|-1.201|0.374||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.374|-1.201|0.303
72376286|NCT02880956|144261933|SUPERIORITY||Effect size/pooled SD|-0.13|STANDARD_DEVIATION|3.28|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
72376287|NCT02880956|144261933|SUPERIORITY||LS Mean of Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.412||0.23|TWO_SIDED|95.0|-1.307|0.315||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.315|-1.307|0.230
72376288|NCT02880956|144261933|SUPERIORITY||Effect size/pooled SD|-0.14|STANDARD_DEVIATION|3.53|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
72376289|NCT02880956|144261933|SUPERIORITY||LS Mean of Difference|-0.67|STANDARD_ERROR_OF_MEAN|0.5222||0.2|TWO_SIDED|95.0|-1.698|0.356||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||0.356|-1.698|0.200
72504981|NCT01462292|144541163|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2054.86||||0.248|TWO_SIDED|95.0|-5587.33|1477.6||No adjustment for multiplicity was made, so p-values should not be used to make conclusions with regards to statistical significance|Mixed Model Repeated Measures|Model included terms for treatment, visit, treatment by visit, center grouping, baseline and baseline by visit||Treatment difference: Placebo Vs GSK2402968 3 mg, Week 48||1477.60|-5587.33|0.248
72376290|NCT02880956|144261933|SUPERIORITY||Effect size/pooled SD|-0.16|STANDARD_DEVIATION|4.07|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
72376291|NCT02880956|144261933|SUPERIORITY||LS Mean of Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.508||0.873|TWO_SIDED|95.0|-1.08|0.917||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||0.917|-1.080|0.873
72376292|NCT02880956|144261933|SUPERIORITY||Effect size/pooled SD|-0.02|STANDARD_DEVIATION|4.13|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
72376293|NCT02880956|144261933|SUPERIORITY||LS Mean of Difference|-0.45|STANDARD_ERROR_OF_MEAN|0.524||0.388|TWO_SIDED|95.0|-1.482|0.576||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||0.576|-1.482|0.388
72376294|NCT02880956|144261933|SUPERIORITY||Effect size/pooled SD|-0.12|STANDARD_DEVIATION|3.92|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
72376295|NCT02880956|144261933|SUPERIORITY||LS Mean of Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.587||0.734|TWO_SIDED|95.0|-1.355|0.955||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||0.955|-1.355|0.734
72376296|NCT02880956|144261933|SUPERIORITY||Effect size/pooled SD|-0.05|STANDARD_DEVIATION|3.91|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
72376297|NCT02880956|144261933|SUPERIORITY||LS Mean of Difference|-0.47|STANDARD_ERROR_OF_MEAN|0.579||0.417|TWO_SIDED|95.0|-1.608|0.668||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||0.668|-1.608|0.417
72376298|NCT02880956|144261933|SUPERIORITY||Effect size/pooled SD|-0.11|STANDARD_DEVIATION|4.14|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
72376299|NCT02880956|144261933|SUPERIORITY||LS Mean of Difference|-0.68|STANDARD_ERROR_OF_MEAN|0.589||0.252|TWO_SIDED|95.0|-1.836|0.482||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||0.482|-1.836|0.252
72376300|NCT02880956|144261933|SUPERIORITY||Effect size/pooled SD|-0.16|STANDARD_DEVIATION|4.16|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
72376301|NCT02880956|144261933|SUPERIORITY||LS Mean of Difference|0.15|STANDARD_ERROR_OF_MEAN|0.669||0.827|TWO_SIDED|95.0|-1.17|1.462||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||1.462|-1.170|0.827
72376302|NCT02880956|144261933|SUPERIORITY||Effect size/pooled SD|0.03|STANDARD_DEVIATION|4.69|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
72376303|NCT02880956|144261933|SUPERIORITY||LS Mean of Difference|0.33|STANDARD_ERROR_OF_MEAN|0.657||0.615|TWO_SIDED|95.0|-0.962|1.624||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|repeated measures model|||Week 96||1.624|-0.962|0.615
72556076|NCT00462228|144643399|SUPERIORITY_OR_OTHER|||||||1||95.0||||12 week comparison, alpha = 0.05.|Sign test|||Null hypothesis: The change from baseline occurring with memantine is equal to the change from baseline occurring with placebo at 12 weeks for the Trail Making Test Part B.||||1.0
72376304|NCT02880956|144261933|SUPERIORITY||Effect size/pooled SD|0.07|STANDARD_DEVIATION|4.61|||TWO_SIDED|||||||||Week 96||||
72376305|NCT02880956|144261933|SUPERIORITY||LS Mean of Difference|-0.32|STANDARD_ERROR_OF_MEAN|0.678||0.637|TWO_SIDED|95.0|-1.653|1.014||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||1.014|-1.653|0.637
72376306|NCT02880956|144261933|SUPERIORITY||Effect size/pooled SD|-0.07|STANDARD_DEVIATION|4.89|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
72376307|NCT02880956|144261934|SUPERIORITY||LS Mean of Difference|-0.41|STANDARD_ERROR_OF_MEAN|0.367||0.261|TWO_SIDED|95.0|-1.135|0.308||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.308|-1.135|0.261
72376308|NCT02880956|144261934|SUPERIORITY||Effect size/pooled SD|-0.13|STANDARD_DEVIATION|3.12|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
72556077|NCT00462228|144643399|SUPERIORITY_OR_OTHER|||||||0.17||95.0||||6 week comparison, alpha = 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis: The change from baseline occurring with memantine is equal to the change from baseline occurring with placebo at 6 weeks for the Trail Making Test Part B.||||0.17
72376309|NCT02880956|144261934|SUPERIORITY||LS Mean of Difference|0.29|STANDARD_ERROR_OF_MEAN|0.361||0.423|TWO_SIDED|95.0|-0.42|1.001||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||1.001|-0.420|0.423
72376310|NCT02880956|144261934|SUPERIORITY||Effect size/pooled SD|0.09|STANDARD_DEVIATION|3.23|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
72376311|NCT02880956|144261934|SUPERIORITY||LS Mean of Difference|-0.37|STANDARD_ERROR_OF_MEAN|0.371||0.322|TWO_SIDED|95.0|-1.097|0.361||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.361|-1.097|0.322
72376312|NCT02880956|144261934|SUPERIORITY||Effect size/pooled SD|-0.15|STANDARD_DEVIATION|2.48|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
72376313|NCT02880956|144261934|SUPERIORITY||LS Mean of Difference|0.27|STANDARD_ERROR_OF_MEAN|0.397||0.498|TWO_SIDED|95.0|-0.511|1.049||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||1.049|-0.511|0.498
72376314|NCT02880956|144261934|SUPERIORITY||Effect size/pooled SD|0.08|STANDARD_DEVIATION|3.33|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
72556078|NCT00462228|144643399|SUPERIORITY_OR_OTHER|||||||0.64||95.0||||12 week comparison, alpha = 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis: The change from baseline occurring with memantine is equal to the change from baseline occurring with placebo at 12 weeks for the Trail Making Test Part B.||||0.64
72556079|NCT00462228|144643400|SUPERIORITY_OR_OTHER|||||||0.34||95.0||||6 week comparison, alpha = 0.05.|Sign test|||Null hypothesis: The change from baseline occurring with memantine is equal to the change from baseline occurring with placebo at 6 weeks for BVMT-R total recall scores.||||0.34
72376315|NCT02880956|144261934|SUPERIORITY||LS Mean of Difference|0.75|STANDARD_ERROR_OF_MEAN|0.386||0.052|TWO_SIDED|95.0|-0.006|1.51||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||1.510|-0.006|0.052
72376316|NCT02880956|144261934|SUPERIORITY||Effect size/pooled SD|0.23|STANDARD_DEVIATION|3.26|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
72376317|NCT02880956|144261934|SUPERIORITY||LS Mean of Difference|-0.21|STANDARD_ERROR_OF_MEAN|0.398||0.597|TWO_SIDED|95.0|-0.993|0.572||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||0.572|-0.993|0.597
72376318|NCT02880956|144261934|SUPERIORITY||Effect size/pooled SD|-0.08|STANDARD_DEVIATION|2.57|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
72376319|NCT02880956|144261934|SUPERIORITY||LS Mean of Difference|0.05|STANDARD_ERROR_OF_MEAN|0.376||0.896|TWO_SIDED|95.0|-0.689|0.788||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||0.788|-0.689|0.896
72376320|NCT02880956|144261934|SUPERIORITY||Effect size/pooled SD|0.01|STANDARD_DEVIATION|3.4|||TWO_SIDED|||||||||Week 72||||
72376321|NCT02880956|144261934|SUPERIORITY||LS Mean of Difference|0.53|STANDARD_ERROR_OF_MEAN|0.369||0.149|TWO_SIDED|95.0|-0.192|1.258||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||1.258|-0.192|0.149
72376322|NCT02880956|144261934|SUPERIORITY||Effect size/pooled SD|0.18|STANDARD_DEVIATION|3.0|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
72376323|NCT02880956|144261934|SUPERIORITY||LS Mean of Difference|-0.24|STANDARD_ERROR_OF_MEAN|0.376||0.522|TWO_SIDED|95.0|-0.98|0.499||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||0.499|-0.980|0.522
72376324|NCT02880956|144261934|SUPERIORITY||Effect size/pooled SD|-0.09|STANDARD_DEVIATION|2.82|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
72376325|NCT02880956|144261934|SUPERIORITY||LS Mean of Difference|-0.27|STANDARD_ERROR_OF_MEAN|0.424||0.528|TWO_SIDED|95.0|-1.103|0.567||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||0.567|-1.103|0.528
72376326|NCT02880956|144261934|SUPERIORITY||Effect size/pooled SD|-0.07|STANDARD_DEVIATION|3.63|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
72376327|NCT02880956|144261934|SUPERIORITY||LS Mean of Difference|0.3|STANDARD_ERROR_OF_MEAN|0.416||0.474|TWO_SIDED|95.0|-0.519|1.116||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||1.116|-0.519|0.474
72376328|NCT02880956|144261934|SUPERIORITY||Effect size/pooled SD|0.09|STANDARD_DEVIATION|3.2|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
72376329|NCT02880956|144261934|SUPERIORITY||LS Mean of Difference|-0.33|STANDARD_ERROR_OF_MEAN|0.429||0.441|TWO_SIDED|95.0|-1.176|0.513||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||0.513|-1.176|0.441
72376330|NCT02880956|144261934|SUPERIORITY||Effect size/pooled SD|-0.11|STANDARD_DEVIATION|3.02|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
72376331|NCT02880956|144261935|SUPERIORITY||LS Mean of Difference|-0.73|STANDARD_ERROR_OF_MEAN|0.331||0.027|TWO_SIDED|95.0|-1.383|-0.082||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||-0.082|-1.383|0.027
72376332|NCT02880956|144261935|SUPERIORITY||Effect size/pooled SD|-0.26|STANDARD_DEVIATION|2.81|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
72376333|NCT02880956|144261935|SUPERIORITY||LS Mean of Difference|-0.48|STANDARD_ERROR_OF_MEAN|0.328||0.146|TWO_SIDED|95.0|-1.123|0.167||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.167|-1.123|0.146
72376334|NCT02880956|144261935|SUPERIORITY||Effect size/pooled SD|-0.16|STANDARD_DEVIATION|2.97|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
72376335|NCT02880956|144261935|SUPERIORITY||LS Mean of Difference|-0.88|STANDARD_ERROR_OF_MEAN|0.335||0.009|TWO_SIDED|95.0|-1.537|-0.22||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||-0.220|-1.537|0.009
72376336|NCT02880956|144261935|SUPERIORITY||Effect size/pooled SD|-0.31|STANDARD_DEVIATION|2.87|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
72376337|NCT02880956|144261935|SUPERIORITY||LS Mean of Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.333||0.952|TWO_SIDED|95.0|-0.674|0.634||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||0.634|-0.674|0.952
72376338|NCT02880956|144261935|SUPERIORITY||Effect size/pooled SD|-0.01|STANDARD_DEVIATION|3.01|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
72376339|NCT02880956|144261935|SUPERIORITY||LS Mean of Difference|0.1|STANDARD_ERROR_OF_MEAN|0.324||0.764|TWO_SIDED|95.0|-0.54|0.734||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||0.734|-0.540|0.764
72376340|NCT02880956|144261935|SUPERIORITY||Effect size/pooled SD|0.03|STANDARD_DEVIATION|2.85|||TWO_SIDED|||||||||Week 48||||
72376341|NCT02880956|144261935|SUPERIORITY||LS Mean of Difference|-0.54|STANDARD_ERROR_OF_MEAN|0.331||0.103|TWO_SIDED|95.0|-1.191|0.109||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||0.109|-1.191|0.103
72376342|NCT02880956|144261935|SUPERIORITY||Effect size/pooled SD|-0.19|STANDARD_DEVIATION|2.83|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
72376343|NCT02880956|144261935|SUPERIORITY||LS Mean of Difference|-0.68|STANDARD_ERROR_OF_MEAN|0.362||0.06|TWO_SIDED|95.0|-1.396|0.028||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||0.028|-1.396|0.060
72376344|NCT02880956|144261935|SUPERIORITY||Effect size/pooled SD|-0.22|STANDARD_DEVIATION|3.09|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
72376345|NCT02880956|144261935|SUPERIORITY||LS Mean of Difference|-0.61|STANDARD_ERROR_OF_MEAN|0.36||0.091|TWO_SIDED|95.0|-1.316|0.098||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||0.098|-1.316|0.091
72376346|NCT02880956|144261935|SUPERIORITY||Effect size/pooled SD|-0.2|STANDARD_DEVIATION|3.03|||TWO_SIDED|||||||||Week 72||||
72376347|NCT02880956|144261935|SUPERIORITY||LS Mean of Difference|-0.56|STANDARD_ERROR_OF_MEAN|0.361||0.12|TWO_SIDED|95.0|-1.274|0.147||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||0.147|-1.274|0.120
72376348|NCT02880956|144261935|SUPERIORITY||Effect size/pooled SD|-0.19|STANDARD_DEVIATION|2.92|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
72376349|NCT02880956|144261935|SUPERIORITY||LS Mean of Difference|-0.31|STANDARD_ERROR_OF_MEAN|0.395||0.429|TWO_SIDED|95.0|-1.09|0.464||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||0.464|-1.090|0.429
72376350|NCT02880956|144261935|SUPERIORITY||Effect size/pooled SD|-0.1|STANDARD_DEVIATION|3.13|||TWO_SIDED|||||||||Week 96||||
72376351|NCT02880956|144261935|SUPERIORITY||LS Mean of Difference|0.21|STANDARD_ERROR_OF_MEAN|0.389||0.597|TWO_SIDED|95.0|-0.559|0.97||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||0.970|-0.559|0.597
72376352|NCT02880956|144261935|SUPERIORITY||Effect size/pooled SD|0.07|STANDARD_DEVIATION|2.98|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
72376353|NCT02880956|144261935|SUPERIORITY||LS Mean of Difference|0.07|STANDARD_ERROR_OF_MEAN|0.4||0.86|TWO_SIDED|95.0|-0.717|0.858||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||0.858|-0.717|0.860
72376354|NCT02880956|144261935|SUPERIORITY||Effect size/pooled SD|0.02|STANDARD_DEVIATION|3.22|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
72376355|NCT02880956|144261936|SUPERIORITY||LS Mean of Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.497||0.854|TWO_SIDED|95.0|-1.069|0.885||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.885|-1.069|0.854
72376356|NCT02880956|144261936|SUPERIORITY||Effect size/pooled SD|-0.02|STANDARD_DEVIATION|4.02|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
72376357|NCT02880956|144261936|SUPERIORITY||LS Mean of Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.491||0.412|TWO_SIDED|95.0|-1.368|0.562||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.562|-1.368|0.412
72618347|NCT05894564|144767689|OTHER||Odds Ratio (OR)|0.88|||||TWO_SIDED|95.0|0.61|1.28|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 90||1.28|0.61|
72618348|NCT05894564|144767689|OTHER||Odds Ratio (OR)|1.02|||||TWO_SIDED|95.0|0.7|1.49|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 120||1.49|0.70|
72376358|NCT02880956|144261936|SUPERIORITY||Effect size/pooled SD|-0.1|STANDARD_DEVIATION|4.08|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
72556080|NCT00462228|144643400|SUPERIORITY_OR_OTHER|||||||1||95.0||||12 week comparison, alpha = 0.05.|Sign test|||Null hypothesis: The change from baseline occurring with memantine is equal to the change from baseline occurring with placebo at 12 weeks for BVLT-R total recall scores.||||1.0
72376359|NCT02880956|144261936|SUPERIORITY||LS Mean of Difference|-0.57|STANDARD_ERROR_OF_MEAN|0.503||0.262|TWO_SIDED|95.0|-1.554|0.424||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.424|-1.554|0.262
72376360|NCT02880956|144261936|SUPERIORITY||Effect size/pooled SD|-0.15|STANDARD_DEVIATION|3.82|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
72376361|NCT02880956|144261936|SUPERIORITY||LS Mean of Difference|0.91|STANDARD_ERROR_OF_MEAN|0.571||0.11|TWO_SIDED|95.0|-0.209|2.036||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||2.036|-0.209|0.110
72376362|NCT02880956|144261936|SUPERIORITY||Effect size/pooled SD|0.22|STANDARD_DEVIATION|4.09|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
72376363|NCT02880956|144261936|SUPERIORITY||LS Mean of Difference|-0.62|STANDARD_ERROR_OF_MEAN|0.555||0.263|TWO_SIDED|95.0|-1.713|0.469||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||0.469|-1.713|0.263
72376364|NCT02880956|144261936|SUPERIORITY||Effect size/pooled SD|-0.15|STANDARD_DEVIATION|4.21|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
72376365|NCT02880956|144261936|SUPERIORITY||LS Mean of Difference|0.1|STANDARD_ERROR_OF_MEAN|0.57||0.868|TWO_SIDED|95.0|-1.026|1.217||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||1.217|-1.026|0.868
72376366|NCT02880956|144261936|SUPERIORITY||Effect size/pooled SD|0.02|STANDARD_DEVIATION|3.92|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
72376367|NCT02880956|144261936|SUPERIORITY||LS Mean of Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.592||0.82|TWO_SIDED|95.0|-1.298|1.029||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||1.029|-1.298|0.820
72376368|NCT02880956|144261936|SUPERIORITY||Effect size/pooled SD|-0.03|STANDARD_DEVIATION|4.49|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
72618349|NCT05894564|144767690|OTHER||Odds Ratio (OR)|1.01|||||TWO_SIDED|95.0|0.8|1.27|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 7||1.27|0.80|
72618350|NCT05894564|144767690|OTHER||Odds Ratio (OR)|0.98|||||TWO_SIDED|95.0|0.77|1.26|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 14||1.26|0.77|
72376369|NCT02880956|144261936|SUPERIORITY||LS Mean of Difference|0.16|STANDARD_ERROR_OF_MEAN|0.583||0.781|TWO_SIDED|95.0|-0.984|1.308||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||1.308|-0.984|0.781
72376370|NCT02880956|144261936|SUPERIORITY||Effect size/pooled SD|0.04|STANDARD_DEVIATION|4.49|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
72376371|NCT02880956|144261936|SUPERIORITY||LS Mean of Difference|0.08|STANDARD_ERROR_OF_MEAN|0.59||0.895|TWO_SIDED|95.0|-1.082|1.238||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||1.238|-1.082|0.895
72376372|NCT02880956|144261936|SUPERIORITY||Effect size/pooled SD|0.02|STANDARD_DEVIATION|4.75|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
72376373|NCT02880956|144261936|SUPERIORITY||LS Mean of Difference|0.63|STANDARD_ERROR_OF_MEAN|0.69||0.359|TWO_SIDED|95.0|-0.724|1.991||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||1.991|-0.724|0.359
72376374|NCT02880956|144261936|SUPERIORITY||Effect size/pooled SD|0.14|STANDARD_DEVIATION|4.55|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
72376375|NCT02880956|144261936|SUPERIORITY||LS Mean of Difference|0.34|STANDARD_ERROR_OF_MEAN|0.675||0.612|TWO_SIDED|95.0|-0.985|1.67||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||1.670|-0.985|0.612
72376376|NCT02880956|144261936|SUPERIORITY||Effect size/pooled SD|0.07|STANDARD_DEVIATION|4.72|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
72376377|NCT02880956|144261936|SUPERIORITY||LS Mean of Difference|0.5|STANDARD_ERROR_OF_MEAN|0.696||0.475|TWO_SIDED|95.0|-0.872|1.867||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||1.867|-0.872|0.475
72376378|NCT02880956|144261936|SUPERIORITY||Effect size/pooled SD|0.11|STANDARD_DEVIATION|4.57|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
72556081|NCT00462228|144643400|SUPERIORITY_OR_OTHER|||||||0.54||95.0||||6 week comparison, alpha = 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis: The change from baseline occurring with memantine is equal to the change from baseline occurring with placebo at 6 weeks for HVLT-R total recall scores.||||0.54
72618351|NCT05894564|144767690|OTHER||Odds Ratio (OR)|0.87|||||TWO_SIDED|95.0|0.67|1.14|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 28||1.14|0.67|
72618352|NCT05894564|144767690|OTHER||Odds Ratio (OR)|1.02|||||TWO_SIDED|95.0|0.77|1.36|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 90||1.36|0.77|
72618353|NCT05894564|144767690|OTHER||Odds Ratio (OR)|1.01|||||TWO_SIDED|95.0|0.76|1.33|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 120||1.33|0.76|
72618354|NCT05894564|144767691|OTHER||Odds Ratio (OR)|0.85|||||TWO_SIDED|95.0|0.65|1.09|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 7||1.09|0.65|
72556082|NCT00462228|144643400|SUPERIORITY_OR_OTHER|||||||0.91||95.0||||12 week comparison, alpha = 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis: The change from baseline occurring with memantine is equal to the change from baseline occurring with placebo at 12 weeks for BVLT-R total recall scores.||||0.91
72556083|NCT00462228|144643401|SUPERIORITY_OR_OTHER|||||||0.34||95.0||||6 week comparison, alpha = 0.05.|Sign test|||Null hypothesis: The change from baseline occurring with memantine is equal to the change from baseline occurring with placebo at 6 weeks for BVMT-R delayed recall scores.||||0.34
72556084|NCT00462228|144643401|SUPERIORITY_OR_OTHER|||||||0.55||95.0||||12 week comparison, alpha = 0.05.|Sign test|||Null hypothesis: The change from baseline occurring with memantine is equal to the change from baseline occurring with placebo at 12 weeks for BVMT-R delayed recall scores.||||0.55
72556085|NCT00462228|144643401|SUPERIORITY_OR_OTHER|||||||0.37||95.0||||6 week comparison, alpha = 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis: The change from baseline occurring with memantine is equal to the change from baseline occurring with placebo at 6 weeks for BVMT-R delayed recall scores.||||0.37
72556086|NCT00462228|144643401|SUPERIORITY_OR_OTHER|||||||0.95||95.0||||12 week comparison, alpha = 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis: The change from baseline occurring with memantine is equal to the change from baseline occurring with placebo at 12 weeks for BVMT-R delayed recall scores.||||0.95
72556087|NCT00462228|144643402|SUPERIORITY_OR_OTHER|||||||0.75||95.0||||6 week comparison, alpha = 0.05.|Sign test|||Null hypothesis: The change from baseline occurring with memantine is equal to the change from baseline occurring with placebo at 6 weeks for the SDMT Written Score.||||0.75
72618355|NCT05894564|144767691|OTHER||Odds Ratio (OR)|0.99|||||TWO_SIDED|95.0|0.74|1.32|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 14||1.32|0.74|
72618356|NCT05894564|144767691|OTHER||Odds Ratio (OR)|0.88|||||TWO_SIDED|95.0|0.64|1.21|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 28||1.21|0.64|
72376379|NCT02880956|144261937|SUPERIORITY||LS Mean of Difference|0.04|STANDARD_ERROR_OF_MEAN|0.427||0.926|TWO_SIDED|95.0|-0.799|0.878||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.878|-0.799|0.926
72556088|NCT00462228|144643402|SUPERIORITY_OR_OTHER|||||||0.51||95.0||||12 week comparison, alpha = 0.05.|Sign test|||Null hypothesis: The change from baseline occurring with memantine is equal to the change from baseline occurring with placebo at 12 weeks for the SDMT Written Score.||||0.51
72556089|NCT00462228|144643402|SUPERIORITY_OR_OTHER|||||||0.31||95.0||||6 week comparison, alpha = 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis: The change from baseline occurring with memantine is equal to the change from baseline occurring with placebo at 6 weeks for the SDMT Written Score.||||0.31
72556090|NCT00462228|144643402|SUPERIORITY_OR_OTHER|||||||0.46||95.0||||12 week comparison, alpha = 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis: The change from baseline occurring with memantine is equal to the change from baseline occurring with placebo at 12 weeks for the SDMT Written Score.||||0.46
72556091|NCT00462228|144643403|SUPERIORITY_OR_OTHER|||||||0.34||95.0||||6 week comparison, alpha = 0.05.|Sign test|||Null hypothesis: The change from baseline occurring with memantine is equal to the change from baseline occurring with placebo at 6 weeks for the SDMT Oral Score.||||0.34
72556092|NCT00462228|144643403|SUPERIORITY_OR_OTHER|||||||0.75||95.0||||12 week comparison, alpha = 0.05.|Sign test|||Null hypothesis: The change from baseline occurring with memantine is equal to the change from baseline occurring with placebo at 12 weeks for the SDMT Oral Score.||||0.75
72556093|NCT00462228|144643403|SUPERIORITY_OR_OTHER|||||||0.37||95.0||||6 week comparison, alpha = 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis: The change from baseline occurring with memantine is equal to the change from baseline occurring with placebo at 6 weeks for the SDMT Oral Score.||||0.37
72618357|NCT05894564|144767691|OTHER||Odds Ratio (OR)|1.22|||||TWO_SIDED|95.0|0.87|1.73|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 90||1.73|0.87|
72618358|NCT05894564|144767691|OTHER||Odds Ratio (OR)|1.18|||||TWO_SIDED|95.0|0.85|1.64|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 120||1.64|0.85|
72618359|NCT05894564|144767692|OTHER||Odds Ratio (OR)|0.99|||||TWO_SIDED|95.0|0.74|1.33|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 7||1.33|0.74|
72376380|NCT02880956|144261937|SUPERIORITY||Effect size/pooled SD|0.01|STANDARD_DEVIATION|3.78|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
72376381|NCT02880956|144261937|SUPERIORITY||LS Mean of Difference|-0.25|STANDARD_ERROR_OF_MEAN|0.423||0.553|TWO_SIDED|95.0|-1.082|0.58||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.580|-1.082|0.553
72376382|NCT02880956|144261937|SUPERIORITY||Effect size/pooled SD|-0.06|STANDARD_DEVIATION|3.96|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
72376383|NCT02880956|144261937|SUPERIORITY||LS Mean of Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.432||0.69|TWO_SIDED|95.0|-1.021|0.677||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.677|-1.021|0.690
72376384|NCT02880956|144261937|SUPERIORITY||Effect size/pooled SD|-0.04|STANDARD_DEVIATION|4.13|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
72376385|NCT02880956|144261937|SUPERIORITY||LS Mean of Difference|0.9|STANDARD_ERROR_OF_MEAN|0.499||0.073|TWO_SIDED|95.0|-0.085|1.879||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||1.879|-0.085|0.073
72376386|NCT02880956|144261937|SUPERIORITY||Effect size/pooled SD|0.22|STANDARD_DEVIATION|4.03|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
72376387|NCT02880956|144261937|SUPERIORITY||LS Mean of Difference|0.32|STANDARD_ERROR_OF_MEAN|0.487||0.517|TWO_SIDED|95.0|-0.641|1.273||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|repeated measures model|||Week 48||1.273|-0.641|0.517
72376388|NCT02880956|144261937|SUPERIORITY||Effect size/pooled SD|0.07|STANDARD_DEVIATION|4.21|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
72376389|NCT02880956|144261937|SUPERIORITY||LS Mean of Difference|0.38|STANDARD_ERROR_OF_MEAN|0.501||0.454|TWO_SIDED|95.0|-0.609|1.36||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||1.360|-0.609|0.454
72556094|NCT00462228|144643403|SUPERIORITY_OR_OTHER|||||||0.45||95.0||||12 week comparison, alpha = 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis: The change from baseline occurring with memantine is equal to the change from baseline occurring with placebo at 12 weeks for the SDMT Oral Score.||||0.45
72376390|NCT02880956|144261937|SUPERIORITY||Effect size/pooled SD|0.08|STANDARD_DEVIATION|4.45|||TWO_SIDED|||||||||Week 48||||
72376391|NCT02880956|144261937|SUPERIORITY||LS Mean of Difference|0.57|STANDARD_ERROR_OF_MEAN|0.522||0.276|TWO_SIDED|95.0|-0.456|1.596||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||1.596|-0.456|0.276
72376392|NCT02880956|144261937|SUPERIORITY||Effect size/pooled SD|0.14|STANDARD_DEVIATION|3.94|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
72376393|NCT02880956|144261937|SUPERIORITY||LS Mean of Difference|0.04|STANDARD_ERROR_OF_MEAN|0.516||0.935|TWO_SIDED|95.0|-0.973|1.058||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||1.058|-0.973|0.935
72376394|NCT02880956|144261937|SUPERIORITY||Effect size/pooled SD|0.01|STANDARD_DEVIATION|4.35|||TWO_SIDED|95.0|||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
72376395|NCT02880956|144261937|SUPERIORITY||LS Mean of Difference|0.04|STANDARD_ERROR_OF_MEAN|0.523||0.942|TWO_SIDED|95.0|-0.99|1.066||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||1.066|-0.990|0.942
72376396|NCT02880956|144261937|SUPERIORITY||Effect size/pooled SD|0.01|STANDARD_DEVIATION|4.35|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
72376397|NCT02880956|144261937|SUPERIORITY||LS Mean of Difference|0.32|STANDARD_ERROR_OF_MEAN|0.569||0.578|TWO_SIDED|95.0|-0.802|1.436||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||1.436|-0.802|0.578
72376398|NCT02880956|144261937|SUPERIORITY||Effect size/pooled SD|0.09|STANDARD_DEVIATION|3.57|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
72376399|NCT02880956|144261937|SUPERIORITY||LS Mean of Difference|0.56|STANDARD_ERROR_OF_MEAN|0.34||0.545|TWO_SIDED|95.0|-0.762|1.441||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|repeated measures model|||Week 96||1.441|-0.762|0.545
72376400|NCT02880956|144261937|SUPERIORITY||Effect size/pooled SD|0.09|STANDARD_DEVIATION|3.94|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
72556095|NCT03437265|144643407|OTHER||||||||||||||||||PK parameters were estimated for each subject by non-compartmental analysis methods using Phoenix® WinNonlin® software (v8.0, Certara USA, Inc., USA). Summary statistics (n, mean, SD, CV%, median, minimum, maximum, geometric n, geometric mean (geometric SD) and geometric CV%) were presented.|||
72376401|NCT02880956|144261937|SUPERIORITY||LS Mean of Difference|-0.55|STANDARD_ERROR_OF_MEAN|0.583||0.346|TWO_SIDED|95.0|-1.697|0.597||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||0.597|-1.697|0.346
72376402|NCT02880956|144261937|SUPERIORITY||Effect size/pooled SD|-0.14|STANDARD_DEVIATION|3.81|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
72376403|NCT02880956|144261938|SUPERIORITY||LS Mean of Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.146||0.202|TWO_SIDED|95.0|-0.473|0.1||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.100|-0.473|0.202
72376404|NCT02880956|144261938|SUPERIORITY||Effect size/pooled SD|-0.15|STANDARD_DEVIATION|1.26|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
72376405|NCT02880956|144261938|SUPERIORITY||LS Mean of Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.144||0.76|TWO_SIDED|95.0|-0.327|0.239||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.239|-0.327|0.760
72376406|NCT02880956|144261938|SUPERIORITY||Effect size/pooled SD|-0.04|STANDARD_DEVIATION|1.15|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
72376407|NCT02880956|144261938|SUPERIORITY||LS Mean of Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.147||0.419|TWO_SIDED|95.0|-0.409|0.17||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.170|-0.409|0.419
72376408|NCT02880956|144261938|SUPERIORITY||Effect size/pooled SD|-0.12|STANDARD_DEVIATION|1.03|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
72376409|NCT02880956|144261938|SUPERIORITY||LS Mean of Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.173||0.893|TWO_SIDED|95.0|-0.363|0.317||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||0.317|-0.363|0.893
72556096|NCT03437265|144643408|OTHER||||||||||||||||||PK parameters were estimated for each subject by non-compartmental analysis methods using Phoenix® WinNonlin® software (v8.0, Certara USA, Inc., USA). Summary statistics (n, mean, SD, CV%, median, minimum, maximum, geometric n, geometric mean (geometric SD) and geometric CV%) were presented.|||
72618360|NCT05894564|144767692|OTHER||Odds Ratio (OR)|0.8|||||TWO_SIDED|95.0|0.59|1.1|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 14||1.10|0.59|
72376410|NCT02880956|144261938|SUPERIORITY||Effect size/pooled SD|-0.02|STANDARD_DEVIATION|1.26|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|||||
72376411|NCT02880956|144261938|SUPERIORITY||LS Mean of Difference|0.02|STANDARD_ERROR_OF_MEAN|0.168||0.886|TWO_SIDED|95.0|-0.306|0.354||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||0.354|-0.306|0.886
72376412|NCT02880956|144261938|SUPERIORITY||Effect size/pooled SD|0.02|STANDARD_DEVIATION|1.46|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
72376413|NCT02880956|144261938|SUPERIORITY||LS Mean of Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.172||0.306|TWO_SIDED|95.0|-0.515|0.162||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||0.162|-0.515|0.306
72376414|NCT02880956|144261938|SUPERIORITY||Effect size/pooled SD|-0.16|STANDARD_DEVIATION|1.12|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
72376415|NCT02880956|144261938|SUPERIORITY||LS Mean of Difference|-0.31|STANDARD_ERROR_OF_MEAN|0.116||0.008|TWO_SIDED|95.0|-0.535|-0.079||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||-0.079|-0.535|0.008
72376416|NCT02880956|144261938|SUPERIORITY||Effect size/pooled SD|-0.26|STANDARD_DEVIATION|1.2|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
72376417|NCT02880956|144261938|SUPERIORITY||LS Mean of Difference|-0.25|STANDARD_ERROR_OF_MEAN|0.115||0.031|TWO_SIDED|95.0|-0.474|-0.023||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||-0.023|-0.474|0.031
72376418|NCT02880956|144261938|SUPERIORITY||Effect size/pooled SD|-0.21|STANDARD_DEVIATION|1.16|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
72618361|NCT05894564|144767692|OTHER||Odds Ratio (OR)|0.81|||||TWO_SIDED|95.0|0.59|1.12|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 28||1.12|0.59|
72376419|NCT02880956|144261938|SUPERIORITY||LS Mean of Difference|-0.29|STANDARD_ERROR_OF_MEAN|0.116||0.014|TWO_SIDED|95.0|-0.514|-0.059||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||-0.059|-0.514|0.014
72376420|NCT02880956|144261938|SUPERIORITY||Effect size/pooled SD|-0.25|STANDARD_DEVIATION|1.15|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|||||
72376421|NCT02880956|144261938|SUPERIORITY||LS Mean of Difference|-0.25|STANDARD_ERROR_OF_MEAN|0.135||0.065|TWO_SIDED|95.0|-0.514|0.016||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||0.016|-0.514|0.065
72376422|NCT02880956|144261938|SUPERIORITY||Effect size/pooled SD|-0.21|STANDARD_DEVIATION|1.17|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
72376423|NCT02880956|144261938|SUPERIORITY||LS Mean of Difference|-0.21|STANDARD_ERROR_OF_MEAN|0.132||0.121|TWO_SIDED|95.0|-0.465|0.055||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||0.055|-0.465|0.121
72376424|NCT02880956|144261938|SUPERIORITY||Effect size/pooled SD|1.05|STANDARD_DEVIATION|1.17|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
72556097|NCT03437265|144643409|OTHER||||||||||||||||||PK parameters were estimated for each subject by non-compartmental analysis methods using Phoenix® WinNonlin® software (v8.0, Certara USA, Inc., USA). Summary statistics (n, mean, SD, CV%, median, minimum, maximum, geometric n, geometric mean (geometric SD) and geometric CV%) were presented.|||
72556098|NCT03437265|144643410|OTHER||||||||||||||||||PK parameters were estimated for each subject by non-compartmental analysis methods using Phoenix® WinNonlin® software (v8.0, Certara USA, Inc., USA). Summary statistics (n, mean, SD, CV%, median, minimum, maximum, geometric n, geometric mean (geometric SD) and geometric CV%) were presented.|||
72556099|NCT03437265|144643411|OTHER||||||||||||||||||PK parameters were estimated for each subject by non-compartmental analysis methods using Phoenix® WinNonlin® software (v8.0, Certara USA, Inc., USA). Summary statistics (n, mean, SD, CV%, median, minimum, maximum, geometric n, geometric mean (geometric SD) and geometric CV%) were presented.|||
72556100|NCT03437265|144643412|OTHER||||||||||||||||||PK parameters were estimated for each subject by non-compartmental analysis methods using Phoenix® WinNonlin® software (v8.0, Certara USA, Inc., USA). Summary statistics (n, mean, SD, CV%, median, minimum, maximum, geometric n, geometric mean (geometric SD) and geometric CV%) were presented. The Geometric CV for glycolic acid was Not Calculated (appears as 0%).|||
72556101|NCT03437265|144643413|OTHER||||||||||||||||||Summary of the number of bowel movements per time period for the PD analysis set|||
72376425|NCT02880956|144261938|SUPERIORITY||LS Mean of Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.136||0.21|TWO_SIDED|95.0|-0.438|0.097||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||0.097|-0.438|0.210
72376426|NCT02880956|144261938|SUPERIORITY||Effect size/pooled SD|-0.17|STANDARD_DEVIATION|1.0|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
72556102|NCT03437265|144643414|OTHER||||||||||||||||||The time (in minutes) to achieve clear effluent/time to turbid contents is presented for the PD analysis set.|||
72376427|NCT02880956|144261939|SUPERIORITY||LS Mean of Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.188||0.303|TWO_SIDED|95.0|-0.564|0.176||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.176|-0.564|0.303
72376428|NCT02880956|144261939|SUPERIORITY||Effect size/pooled SD|-0.14|STANDARD_DEVIATION|1.42|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
72376429|NCT02880956|144261939|SUPERIORITY||LS Mean of Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.186||0.358|TWO_SIDED|95.0|-0.536|0.194||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.194|-0.536|0.358
72376430|NCT02880956|144261939|SUPERIORITY||Effect size/pooled SD|-0.13|STANDARD_ERROR_OF_MEAN|1.31|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
72376431|NCT02880956|144261939|SUPERIORITY||LS Mean of Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.19||0.347|TWO_SIDED|95.0|-0.553|0.195||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.195|-0.553|0.347
72556103|NCT00840476|144643419|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Test/Ref Ratio of LS Means x 100|100.26||||||90.0|93.12|107.95|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||107.95|93.12|
72556104|NCT00840476|144643420|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Test/Ref Ratio of LS Means x 100|105.14||||||90.0|100.27|110.25|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||110.25|100.27|
72556105|NCT00840476|144643421|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Test/Ref Ratio of LS Means x 100|104.33||||||90.0|99.16|109.76|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||109.76|99.16|
72618362|NCT05894564|144767692|OTHER||Odds Ratio (OR)|1.16|||||TWO_SIDED|95.0|0.83|1.62|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 90||1.62|0.83|
72376432|NCT02880956|144261939|SUPERIORITY||Effect size/pooled SD|-0.15|STANDARD_DEVIATION|1.21|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
72618363|NCT05894564|144767692|OTHER||Odds Ratio (OR)|0.97|||||TWO_SIDED|95.0|0.7|1.34|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 120||1.34|0.70|
72618364|NCT05894564|144767693|OTHER||Odds Ratio (OR)|1.03|||||TWO_SIDED|95.0|0.79|1.34|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 7||1.34|0.79|
72618365|NCT05894564|144767693|OTHER||Odds Ratio (OR)|0.99|||||TWO_SIDED|95.0|0.74|1.32|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 14||1.32|0.74|
72618366|NCT05894564|144767693|OTHER||Odds Ratio (OR)|0.88|||||TWO_SIDED|95.0|0.64|1.2|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 28||1.20|0.64|
72618367|NCT05894564|144767693|OTHER||Odds Ratio (OR)|0.96|||||TWO_SIDED|95.0|0.7|1.34|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 90||1.34|0.70|
72618368|NCT05894564|144767693|OTHER||Odds Ratio (OR)|0.9|||||TWO_SIDED|95.0|0.64|1.25|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 120||1.25|0.64|
72618369|NCT05894564|144767694|OTHER||Odds Ratio (OR)|0.79|||||TWO_SIDED|95.0|0.61|1.01|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 7||1.01|0.61|
72376433|NCT02880956|144261939|SUPERIORITY||LS Mean of Difference|0.11|STANDARD_ERROR_OF_MEAN|0.16||0.494|TWO_SIDED|95.0|-0.205|0.423||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||0.423|-0.205|0.494
72618370|NCT05894564|144767694|OTHER||Odds Ratio (OR)|0.85|||||TWO_SIDED|95.0|0.64|1.11|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 14||1.11|0.64|
72618371|NCT05894564|144767694|OTHER||Odds Ratio (OR)|0.84|||||TWO_SIDED|95.0|0.63|1.12|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 28||1.12|0.63|
72618372|NCT05894564|144767694|OTHER||Odds Ratio (OR)|0.82|||||TWO_SIDED|95.0|0.6|1.12|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 90||1.12|0.60|
72618373|NCT05894564|144767694|OTHER||Odds Ratio (OR)|0.91|||||TWO_SIDED|95.0|0.67|1.24|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 120||1.24|0.67|
72618374|NCT05894564|144767695|OTHER||Odds Ratio (OR)|1.02|||||TWO_SIDED|95.0|0.81|1.27|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 7||1.27|0.81|
72618375|NCT05894564|144767695|OTHER||Odds Ratio (OR)|0.95|||||TWO_SIDED|95.0|0.76|1.18|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 14||1.18|0.76|
72618376|NCT05894564|144767695|OTHER||Odds Ratio (OR)|0.91|||||TWO_SIDED|95.0|0.72|1.14|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 28||1.14|0.72|
72618377|NCT05894564|144767695|OTHER||Odds Ratio (OR)|1.0|||||TWO_SIDED|95.0|0.79|1.26|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 90||1.26|0.79|
72376434|NCT02880956|144261939|SUPERIORITY||Effect size/pooled SD|0.09|STANDARD_DEVIATION|1.22|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
72618378|NCT05894564|144767695|OTHER||Odds Ratio (OR)|0.81|||||TWO_SIDED|95.0|0.64|1.01|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 120||1.01|0.64|
72618379|NCT05894564|144767696|SUPERIORITY|Posterior probability of efficacy (P(Difference in MTU (Active - Placebo)\<0))|Difference in model estimate time unwell|-0.17|||||TWO_SIDED|95.0|-0.56|0.26|||||The mean time unwell is estimated from receipt of study drug to study day 14. The interval is a highest density credible interval.|No hypothesis test or decision rule was evaluated.||0.26|-0.56|
72618380|NCT05894564|144767697|SUPERIORITY|Posterior probability of efficacy (P(Difference days benefit (Active - Placebo)\>0))|Difference in model estimated means|0.21|||||TWO_SIDED|95.0|-0.29|0.68|||||The interval is a highest density credible interval.|Analysis is exploratory. No hypothesis test or decision rule was evaluated.||0.68|-0.29|
72376435|NCT02880956|144261939|SUPERIORITY||LS Mean of Difference|0.12|STANDARD_ERROR_OF_MEAN|0.156||0.454|TWO_SIDED|95.0|-0.189|0.423||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||0.423|-0.189|0.454
72376436|NCT02880956|144261939|SUPERIORITY||Effect size/pooled SD|0.1|STANDARD_DEVIATION|1.13|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
72376437|NCT02880956|144261939|SUPERIORITY||LS Mean of Difference|0.07|STANDARD_DEVIATION|0.16||0.644|TWO_SIDED|95.0|-0.24|0.388||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||0.388|-0.240|0.644
72376438|NCT02880956|144261939|SUPERIORITY||Effect size/pooled SD|0.07|STANDARD_DEVIATION|1.1|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
72376439|NCT02880956|144261939|SUPERIORITY||LS Mean of Difference|0.09|STANDARD_ERROR_OF_MEAN|0.232||0.685|TWO_SIDED|95.0|-0.363|0.551||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||0.551|-0.363|0.685
72376440|NCT02880956|144261939|SUPERIORITY||Effect size/pooled SD|0.06|STANDARD_DEVIATION|1.64|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
72376441|NCT02880956|144261939|SUPERIORITY||LS Mean of Difference|0.28|STANDARD_ERROR_OF_MEAN|0.228||0.219|TWO_SIDED|95.0|-0.168|0.73||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||0.730|-0.168|0.219
72376442|NCT02880956|144261939|SUPERIORITY||Effect size/pooled SD|0.18|STANDARD_DEVIATION|1.55|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
72376443|NCT02880956|144261939|SUPERIORITY||LS Mean of Difference|0.15|STANDARD_ERROR_OF_MEAN|0.232||0.507|TWO_SIDED|95.0|-0.302|0.61||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||0.610|-0.302|0.507
72493921|NCT01978093|144516697|NON_INFERIORITY|Lower limit of the two-sided 97.5% CI on the GMC ratio (HibCY group over PedHIB group) for antibodies to S. pneumoniae serotype 19A is to be ≥0.5 (clinical limit for non-inferiority).|Adjusted GMC ratio|1.09|||||TWO_SIDED|97.5|0.9|1.31|||ANCOVA|GMC adjusted for BS sub cohorts;97.5% CI for adjusted GMC ratio(Ancova model:adjustment for BS sub cohorts-pooled variance)|To be able to conclude independently on primary objectives of Epoch 001 \& Epoch 002, a Bonferroni correction is used to test these primary objectives(1.25% one-sided for Epoch 001 and Epoch 002)|GMC ratios between HibCY and PedHIB groups for antibodies to S. pneumoniae serotype 19A concentrations one month after the fourth dose||1.31|0.90|
72376444|NCT02880956|144261939|SUPERIORITY||Effect size/pooled SD|0.1|STANDARD_DEVIATION|1.49|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
72376445|NCT02880956|144261939|SUPERIORITY||LS Mean of Difference|-0.26|STANDARD_ERROR_OF_MEAN|0.216||0.233|TWO_SIDED|95.0|-0.683|0.167||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||0.167|-0.683|0.233
72376446|NCT02880956|144261939|SUPERIORITY||Effect size/pooled SD|-0.2|STANDARD_DEVIATION|1.27|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
72376447|NCT02880956|144261939|SUPERIORITY||LS Mean of Difference|0.03|STANDARD_ERROR_OF_MEAN|0.211||0.881|TWO_SIDED|95.0|-0.383|0.446||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||0.446|-0.383|0.881
72376448|NCT02880956|144261939|SUPERIORITY||Effect size/pooled SD|0.02|STANDARD_DEVIATION|1.42|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
72376449|NCT02880956|144261939|SUPERIORITY||LS Mean of Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.217||0.671|TWO_SIDED|95.0|-0.52|0.335||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||0.335|-0.520|0.671
72376450|NCT02880956|144261939|OTHER||Effect size/pooled SD|-0.08|STANDARD_DEVIATION|1.2|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
72376451|NCT02880956|144261940|SUPERIORITY||LS Mean of Difference|-0.43|STANDARD_ERROR_OF_MEAN|0.409||0.297|TWO_SIDED|95.0|-1.232|0.377||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.377|-1.232|0.297
72376452|NCT02880956|144261940|SUPERIORITY||Effect size/pooled SD|-0.12|STANDARD_DEVIATION|3.7|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
72493922|NCT01978093|144516697|NON_INFERIORITY|Lower limit of the two-sided 97.5% CI on the GMC ratio (HibCY group over PedHIB Group) for antibodies to S. pneumoniae serotype 19F is to be≥0.5 (clinical limit for non-inferiority).|Adjusted GMC ratio|1.12|||||TWO_SIDED|97.5|0.95|1.34|||ANCOVA|GMC adjusted for BS sub cohorts;97.5% CI for adjusted GMC ratio(Ancova model:adjustment for BS sub cohorts-pooled variance)|To be able to conclude independently on primary objectives of Epoch 001 \& Epoch 002, a Bonferroni correction is used to test these primary objectives(1.25% one-sided for Epoch 001 and Epoch 002)|GMC ratios between HibCY and PedHIB groups for antibodies to S. pneumoniae serotype 19F concentrations one month after the fourth dose||1.34|0.95|
72376453|NCT02880956|144261940|SUPERIORITY||LS Mean of Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.405||0.979|TWO_SIDED|95.0|-0.808|0.786||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.786|-0.808|0.979
72376454|NCT02880956|144261940|SUPERIORITY||Effect size/pooled SD|0.0|STANDARD_DEVIATION|3.63|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
72376455|NCT02880956|144261940|SUPERIORITY||LS Mean of Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.415||0.663|TWO_SIDED|95.0|-0.996|0.634||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.634|-0.996|0.663
72376456|NCT02880956|144261940|SUPERIORITY||Effect size/pooled SD|-0.05|STANDARD_DEVIATION|3.71|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
72376457|NCT02880956|144261940|SUPERIORITY||LS Mean of Difference|0.03|STANDARD_ERROR_OF_MEAN|0.636||0.961|TWO_SIDED|95.0|-1.22|1.282||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||1.282|-1.220|0.961
72376458|NCT02880956|144261940|SUPERIORITY||Effect size/pooled SD|0.01|STANDARD_DEVIATION|4.88|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
72376459|NCT02880956|144261940|SUPERIORITY||LS Mean of Difference|0.13|STANDARD_ERROR_OF_MEAN|0.617||0.833|TWO_SIDED|95.0|-1.083|1.344||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||1.344|-1.083|0.833
72376460|NCT02880956|144261940|SUPERIORITY||Effect size/pooled SD|0.03|STANDARD_DEVIATION|5.06|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
72376461|NCT02880956|144261940|OTHER||LS Mean of Difference|0.23|STANDARD_ERROR_OF_MEAN|0.636||0.714|TWO_SIDED|95.0|-1.017|1.484||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||1.484|-1.017|0.714
72376462|NCT02880956|144261940|SUPERIORITY||Effect size/pooled SD|0.05|STANDARD_DEVIATION|5.13|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
72556106|NCT00848536|144643422|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin was 1.5 mmHg.|Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.35|||TWO_SIDED|95.0|-0.9|0.5|||||Treatment group differences were calculated as the mean IOP in the Travoprost APS group minus the mean IOP in the Travatan group. Non-inferiority was demonstrated if the upper 95% CL of the between treatment difference in mean IOP was \< 1.5 mmHg.|A hypothesis test was performed using a repeated measures analysis of variance model. For the test of non-inferiority, a two-sided 95% confidence intervals for the treatment group difference in mean IOP at each visit and time point was constructed based on analysis of variance.||0.5|-0.9|
72376463|NCT02880956|144261940|SUPERIORITY||LS Mean of Difference|-0.43|STANDARD_ERROR_OF_MEAN|0.663||0.518|TWO_SIDED|95.0|-1.733|0.876||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||0.876|-1.733|0.518
72376464|NCT02880956|144261940|SUPERIORITY||Effect size/pooled SD|-0.08|STANDARD_DEVIATION|5.17|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
72376465|NCT02880956|144261940|SUPERIORITY||LS Mean of Difference|-0.31|STANDARD_ERROR_OF_MEAN|0.654||0.633|TWO_SIDED|95.0|-1.598|0.973||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||0.973|-1.598|0.633
72376466|NCT02880956|144261940|SUPERIORITY||Effect size/pooled SD|-0.06|STANDARD_DEVIATION|4.9|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
72376467|NCT02880956|144261940|SUPERIORITY||LS Mean of Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.661||0.776|TWO_SIDED|95.0|-1.488|1.112||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||1.112|-1.488|0.776
72376468|NCT02880956|144261940|SUPERIORITY||Effect size/pooled SD|-0.04|STANDARD_DEVIATION|4.93|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
72376469|NCT02880956|144261940|SUPERIORITY||LS Mean of Difference|-0.58|STANDARD_ERROR_OF_MEAN|0.58||0.316|TWO_SIDED|95.0|-1.723|0.558||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||0.558|-1.723|0.316
72376470|NCT02880956|144261940|SUPERIORITY||Effect size/pooled SD|-0.15|STANDARD_DEVIATION|4.01|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
72376471|NCT02880956|144261940|SUPERIORITY||LS Mean of Difference|-0.55|STANDARD_ERROR_OF_MEAN|0.567||0.336|TWO_SIDED|95.0|-1.66|0.569||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||0.569|-1.660|0.336
72376472|NCT02880956|144261940|SUPERIORITY||Effect size/pooled SD|-0.14|STANDARD_DEVIATION|3.9|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
72376473|NCT02880956|144261940|SUPERIORITY||LS Mean of Difference|-0.49|STANDARD_ERROR_OF_MEAN|0.587||0.403|TWO_SIDED|95.0|-1.647|0.663||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||0.663|-1.647|0.403
72376474|NCT02880956|144261940|SUPERIORITY||Effect size/pooled SD|-0.13|STANDARD_DEVIATION|3.92|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
72376475|NCT02880956|144261941|SUPERIORITY||LS Mean of Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.4||0.861|TWO_SIDED|95.0|-0.856|0.716||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.716|-0.856|0.861
72376476|NCT02880956|144261941|SUPERIORITY||Effect size/pooled SD|-0.02|STANDARD_DEVIATION|3.51|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
72376477|NCT02880956|144261941|SUPERIORITY||LS Mean of Difference|0.13|STANDARD_ERROR_OF_MEAN|0.395||0.746|TWO_SIDED|95.0|-0.648|0.905||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.905|-0.648|0.746
72376478|NCT02880956|144261941|SUPERIORITY||Effect size/pooled SD|0.04|STANDARD_DEVIATION|3.46|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
72376479|NCT02880956|144261941|SUPERIORITY||LS Mean of Difference|0.07|STANDARD_ERROR_OF_MEAN|0.405||0.859|TWO_SIDED|95.0|-0.724|0.868||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.868|-0.724|0.859
72376480|NCT02880956|144261941|SUPERIORITY||Effect size/pooled SD|0.02|STANDARD_DEVIATION|3.64|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
72376481|NCT02880956|144261941|SUPERIORITY||LS Mean of Difference|0.55|STANDARD_ERROR_OF_MEAN|0.467||0.24|TWO_SIDED|95.0|-0.369|1.469||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||1.469|-0.369|0.240
72376482|NCT02880956|144261941|SUPERIORITY||Effect size/pooled SD|0.16|STANDARD_DEVIATION|3.41|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
72376483|NCT02880956|144261941|SUPERIORITY||LS Mean of Difference|0.91|STANDARD_ERROR_OF_MEAN|0.454||0.044|TWO_SIDED|95.0|0.023|1.087||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||1.087|0.023|0.044
72376484|NCT02880956|144261941|SUPERIORITY||Effect size/pooled SD|0.26|STANDARD_DEVIATION|3.51|||TWO_SIDED|||||||||Week 48||||
72376485|NCT02880956|144261941|SUPERIORITY||LS Mean of Difference|0.61|STANDARD_ERROR_OF_MEAN|0.467||0.195|TWO_SIDED|95.0|-0.312|1.524||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||1.524|-0.312|0.195
72376486|NCT02880956|144261941|SUPERIORITY||Effect size/pooled SD|0.17|STANDARD_DEVIATION|3.53|||TWO_SIDED|||||||||Week 48||||
72376487|NCT02880956|144261941|SUPERIORITY||LS Mean of Difference|0.15|STANDARD_ERROR_OF_MEAN|0.547||0.778|TWO_SIDED|95.0|-0.921|1.229||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||1.229|-0.921|0.778
72376488|NCT02880956|144261941|OTHER||Effect size/pooled SD|0.04|STANDARD_DEVIATION|3.99|||TWO_SIDED|||||||||Week 72||||
72376489|NCT02880956|144261941|SUPERIORITY||LS Mean of Difference|0.32|STANDARD_ERROR_OF_MEAN|0.539||0.558|TWO_SIDED|95.0|-0.743|1.376||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||1.376|-0.743|0.558
72376490|NCT02880956|144261941|SUPERIORITY||Effect size/pooled SD|0.08|STANDARD_DEVIATION|3.89|||TWO_SIDED|||||||||Week 72||||
72376491|NCT02880956|144261941|SUPERIORITY||LS Mean of Difference|0.05|STANDARD_ERROR_OF_MEAN|0.546||0.928|TWO_SIDED|95.0|-1.025|1.124||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||1.124|-1.025|0.928
72618381|NCT03882801|144767698|SUPERIORITY||Least Square Geometric Means Ratio|0.92|||||TWO_SIDED|90.0|0.73|1.17|||||Back transformed least squares mean and confidence interval from linear mixed effects model performed on natural log-transformed values.|||1.17|0.73|
72376492|NCT02880956|144261941|SUPERIORITY||Effect size/pooled SD|0.01|STANDARD_DEVIATION|4.27|||TWO_SIDED|||||||||Week 72||||
72376493|NCT02880956|144261941|SUPERIORITY||LS Mean of Difference|0.64|STANDARD_ERROR_OF_MEAN|0.541||0.238|TWO_SIDED|95.0|-0.425|1.704||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||1.704|-0.425|0.238
72376494|NCT02880956|144261941|SUPERIORITY||Effect size/pooled SD|0.18|STANDARD_DEVIATION|3.61|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
72376495|NCT02880956|144261941|SUPERIORITY||LS Mean of Difference|0.86|STANDARD_ERROR_OF_MEAN|0.53||0.107|TWO_SIDED|95.0|-0.186|1.898||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||1.898|-0.186|0.107
72376496|NCT02880956|144261941|SUPERIORITY||Effect size/pooled SD|0.25|STANDARD_DEVIATION|3.41|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
72376497|NCT02880956|144261941|SUPERIORITY||LS Mean of Difference|0.86|STANDARD_ERROR_OF_MEAN|0.548||0.116|TWO_SIDED|95.0|-0.214|1.942||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||1.942|-0.214|0.116
72376498|NCT02880956|144261941|SUPERIORITY||Effect size/pooled SD|0.23|STANDARD_DEVIATION|3.75|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
72376499|NCT02880956|144261942|SUPERIORITY||LS Mean of Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.186||0.683|TWO_SIDED|95.0|-0.442|0.29||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.290|-0.442|0.683
72376500|NCT02880956|144261942|SUPERIORITY||Effect size/pooled SD|-0.04|STANDARD_DEVIATION|1.98|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
72376501|NCT02880956|144261942|SUPERIORITY||LS Mean of Difference|0.01|STANDARD_ERROR_OF_MEAN|0.184||0.973|TWO_SIDED|95.0|-0.356|0.368||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.368|-0.356|0.973
72376502|NCT02880956|144261942|SUPERIORITY||Effect size/pooled SD|0.0|STANDARD_DEVIATION|1.78|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
72376503|NCT02880956|144261942|SUPERIORITY||LS Mean of Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.189||0.921|TWO_SIDED|95.0|-0.389|0.352||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.352|-0.389|0.921
72376504|NCT02880956|144261942|SUPERIORITY||Effect size/pooled SD|-0.01|STANDARD_DEVIATION|1.74|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
72376505|NCT02880956|144261942|SUPERIORITY||LS Mean of Difference|-0.25|STANDARD_ERROR_OF_MEAN|0.256||0.335|TWO_SIDED|95.0|-0.751|0.257||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||0.257|-0.751|0.335
72556107|NCT00848536|144643423|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin was 1.5 mmHg.|Median Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.35|||TWO_SIDED|95.0|-0.8|0.6|||||Treatment group differences were calculated as the mean IOP in the Travoprost APS group minus the mean IOP in the Travatan group. Non-inferiority was demonstrated if the upper 95% CL of the between treatment difference in mean IOP was \< 1.5 mmHg.|A hypothesis test was performed using a repeated measures analysis of variance model. For the test of non-inferiority, a two-sided 95% confidence intervals for the treatment group difference in mean IOP at each visit and time point was constructed based on analysis of variance.||00.6|-0.8|
72618382|NCT03548415|144767720|SUPERIORITY|||||||0.306||||||The p-value was analyzed using the nonparametric test, Van Elteren test with IGF-1 level as stratification factor.|Van Elteren test|||||||0.306
72376506|NCT02880956|144261942|SUPERIORITY||Effect size/pooled SD|-0.11|STANDARD_DEVIATION|2.2|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
72376507|NCT02880956|144261942|SUPERIORITY||LS Mean of Difference|0.11|STANDARD_ERROR_OF_MEAN|0.249||0.67|TWO_SIDED|95.0|-0.383|0.596||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||0.596|-0.383|0.670
72376508|NCT02880956|144261942|SUPERIORITY||Effect size/pooled SD|0.05|STANDARD_DEVIATION|2.01|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
72376509|NCT02880956|144261942|SUPERIORITY||LS Mean of Difference|0.02|STANDARD_ERROR_OF_MEAN|0.256||0.95|TWO_SIDED|95.0|-0.486|0.519||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||0.519|-0.486|0.950
72376510|NCT02880956|144261942|SUPERIORITY||Effect size/pooled SD|0.01|STANDARD_DEVIATION|2.04|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
72376511|NCT02880956|144261942|SUPERIORITY||LS Mean of Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.257||0.383|TWO_SIDED|95.0|-0.729|0.281||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||0.281|-0.729|0.383
72376512|NCT02880956|144261942|SUPERIORITY||Effect size/pooled SD|-0.1|STANDARD_DEVIATION|2.33|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
72376513|NCT02880956|144261942|SUPERIORITY||LS Mean of Difference|0.0|STANDARD_ERROR_OF_MEAN|0.254||0.985|TWO_SIDED|95.0|-0.504|0.494||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||0.494|-0.504|0.985
72376514|NCT02880956|144261942|SUPERIORITY||Effect size/pooled SD|0.0|STANDARD_DEVIATION|2.23|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
72376515|NCT02880956|144261942|SUPERIORITY||LS Mean of Difference|-0.48|STANDARD_ERROR_OF_MEAN|0.256||0.064|TWO_SIDED|95.0|-0.982|0.027||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||0.027|-0.982|0.064
72376516|NCT02880956|144261942|SUPERIORITY||Effect size/pooled SD|-0.2|STANDARD_DEVIATION|2.4|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
72376517|NCT02880956|144261942|SUPERIORITY||LS Mean of Difference|0.18|STANDARD_ERROR_OF_MEAN|0.28||0.527|TWO_SIDED|95.0|-0.374|0.729||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||0.729|-0.374|0.527
72556108|NCT00848536|144643424|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin was 1.5 mmHg.|Median Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.35|||TWO_SIDED|95.0|-0.9|0.5|||||Treatment group differences were calculated as the mean IOP in the Travoprost APS group minus the mean IOP in the Travatan group. Non-inferiority was demonstrated if the upper 95% CL of the between treatment difference in mean IOP was \< 1.5 mmHg.|A hypothesis test was performed using a repeated measures analysis of variance model. For the test of non-inferiority, a two-sided 95% confidence intervals for the treatment group difference in mean IOP at each visit and time point was constructed based on analysis of variance.||0.5|-0.9|
72556109|NCT03261167|144643432|OTHER||Difference|18.1|||||TWO_SIDED|95.0|1.1|35.0||||||||35.0|1.1|
72556110|NCT03261167|144643433|OTHER||Adjusted rate difference|33.1|||||TWO_SIDED|95.0|17.0|49.2|||||Week 2, Elbow flexion. Analysis was based on the Mantel-Haenszel method using Baseline MAS score of the elbow flexors.|||49.2|17.0|
72556111|NCT03261167|144643433|OTHER||Adjusted rate difference|21.7|||||TWO_SIDED|95.0|4.9|38.5|||||Week 4, Elbow flexion. Analysis was based on the Mantel-Haenszel method using Baseline MAS score of the elbow flexors.|||38.5|4.9|
72618383|NCT01292473|144767752|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.69||||0.4637|TWO_SIDED|95.0|-2.54|1.16||Refer to the Type-I error control plan.|ANCOVA|Covariates included in the analysis were baseline weekly itch severity score (\< 13 vs ≥ 13) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis is that there is no difference between the placebo and omalizumab 75 mg groups.||1.16|-2.54|0.4637
72618384|NCT01292473|144767752|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-3.04||||0.0011|TWO_SIDED|95.0|-4.85|-1.24||Refer to the Type-I error control plan.|ANCOVA|Covariates included in the analysis were baseline weekly itch severity score (\< 13 vs ≥ 13) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis is that there is no difference between the placebo and omalizumab 150 mg groups.||-1.24|-4.85|0.0011
72618385|NCT01292473|144767752|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-4.81|||<|0.0001|TWO_SIDED|95.0|-6.49|-3.13||Refer to the Type-I error control plan.|ANCOVA|Covariates included in the analysis were baseline weekly itch severity score (\< 13 vs ≥ 13) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis is that there is no difference between the placebo and omalizumab 300 mg groups.||-3.13|-6.49|<0.0001
72376518|NCT02880956|144261942|SUPERIORITY||Effect size/pooled SD|0.08|STANDARD_DEVIATION|2.3|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
72376519|NCT02880956|144261942|SUPERIORITY||LS Mean of Difference|0.31|STANDARD_ERROR_OF_MEAN|0.275||0.254|TWO_SIDED|95.0|-0.226|0.854||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||0.854|-0.226|0.254
72556112|NCT03261167|144643433|OTHER||Adjusted rate difference|18.4|||||TWO_SIDED|95.0|1.3|35.5|||||Week 6, Elbow flexion. Analysis was based on the Mantel-Haenszel method using Baseline MAS score of the elbow flexors.|||35.5|1.3|
72556113|NCT03261167|144643433|OTHER||Adjusted rate difference|12.9|||||TWO_SIDED|95.0|-4.2|30.1|||||Week 12, Elbow flexion. Analysis was based on the Mantel-Haenszel method using Baseline MAS score of the elbow flexors.|||30.1|-4.2|
72618386|NCT01292473|144767753|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-2.73||||0.1575|TWO_SIDED|95.0|-6.53|1.07||Refer to the Type-I error control plan. The p-value was not evaluated for statistical significance in accordance with the Type I error control plan provided in the Detailed Description.|ANCOVA|Covariates included in the analysis were baseline UAS7 (\< median vs ≥ median) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis is that there is no difference between the placebo and omalizumab 75 mg groups.||1.07|-6.53|0.1575
72618387|NCT01292473|144767753|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-7.69||||0.0001||95.0|-11.49|-3.88||Refer to the Type-I error control plan.|ANCOVA|Covariates included in the analysis were baseline UAS7 (\< median vs ≥ median) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis is that there is no difference between the placebo and omalizumab 150 mg groups.||-3.88|-11.49|0.0001
72618388|NCT01292473|144767753|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-12.4|||<|0.0001|TWO_SIDED|95.0|-16.13|-8.66||Refer to the Type-I error control plan.|ANCOVA|Covariates included in the analysis were baseline UAS7 (\< median vs ≥ median) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis is that there is no difference between the placebo and omalizumab 300 mg groups.||-8.66|-16.13|<0.0001
72556114|NCT03261167|144643433|OTHER||Adjusted rate difference|-5.6|||||TWO_SIDED|95.0|-20.9|9.8|||||Week 2, Wrist flexion. Analysis was based on the Mantel-Haenszel method using Baseline MAS score of the elbow flexors.|||9.8|-20.9|
72556115|NCT03261167|144643433|OTHER||Adjusted rate difference|-8.6|||||TWO_SIDED|95.0|-23.0|5.9|||||Week 4, Wrist flexion. Analysis was based on the Mantel-Haenszel method using Baseline MAS score of the elbow flexors.|||5.9|-23.0|
72556116|NCT03261167|144643433|OTHER||Adjusted rate difference|-12.1|||||TWO_SIDED|95.0|-27.5|3.2|||||Week 6, Wrist flexion. Analysis was based on the Mantel-Haenszel method using Baseline MAS score of the elbow flexors.|||3.2|-27.5|
72556117|NCT03261167|144643433|OTHER||Adjusted rate difference|-9.6|||||TWO_SIDED|95.0|-27.2|7.9|||||Week 12, Wrist flexion. Analysis was based on the Mantel-Haenszel method using Baseline MAS score of the elbow flexors.|||7.9|-27.2|
72556118|NCT03261167|144643433|OTHER||Adjusted rate difference|-8.6|||||TWO_SIDED|95.0|-21.9|4.7|||||Week 2, Finger flexion. Analysis was based on the Mantel-Haenszel method using Baseline MAS score of the elbow flexors.|||4.7|-21.9|
72556119|NCT03261167|144643433|OTHER||Adjusted rate difference|-10.4|||||TWO_SIDED|95.0|-24.3|3.4|||||Week 4, Finger flexion. Analysis was based on the Mantel-Haenszel method using Baseline MAS score of the elbow flexors.|||3.4|-24.3|
72556120|NCT03261167|144643433|OTHER||Adjusted rate difference|-8.9|||||TWO_SIDED|95.0|-23.8|6.0|||||Week 6, Finger flexion. Analysis was based on the Mantel-Haenszel method using Baseline MAS score of the elbow flexors.|||6.0|-23.8|
72376520|NCT02880956|144261942|SUPERIORITY||Effect size/pooled SD|0.14|STANDARD_DEVIATION|2.32|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
72376521|NCT02880956|144261942|SUPERIORITY||LS Mean of Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.284||0.805|TWO_SIDED|95.0|-0.628|0.488||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||0.488|-0.628|0.805
72376522|NCT02880956|144261942|SUPERIORITY||Effect size/pooled SD|-0.03|STANDARD_DEVIATION|2.13|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
72376523|NCT02880956|144261943|SUPERIORITY||LS Mean of Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.361||0.534|TWO_SIDED|95.0|-0.935|0.485||The statistical model: MMSE change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.485|-0.935|0.534
72376524|NCT02880956|144261943|SUPERIORITY||Effect size/pooled SD|-0.08|STANDARD_DEVIATION|2.76|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
72376525|NCT02880956|144261943|SUPERIORITY||LS Mean of Difference|0.12|STANDARD_ERROR_OF_MEAN|0.356||0.735|TWO_SIDED|95.0|-0.58|0.821||The statistical model: MMSE change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.821|-0.580|0.735
72376526|NCT02880956|144261943|SUPERIORITY||Effect size/pooled SD|0.04|STANDARD_DEVIATION|2.74|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
72376527|NCT02880956|144261943|SUPERIORITY||LS Mean of Difference|-0.96|STANDARD_ERROR_OF_MEAN|0.365||0.009|TWO_SIDED|95.0|-1.673|-0.24||The statistical model: MMSE change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||-0.240|-1.673|0.009
72376528|NCT02880956|144261943|SUPERIORITY||Effect size/pooled SD|-0.35|STANDARD_DEVIATION|2.75|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
72376529|NCT02880956|144261943|SUPERIORITY||LS Mean of Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.422||0.954|TWO_SIDED|95.0|-0.854|0.806||The statistical model: MMSE change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||0.806|-0.854|0.954
72493923|NCT01978093|144516697|NON_INFERIORITY|Lower limit of the two-sided 97.5% CI on the GMC ratio (HibCY group over PedHIB group) for antibodies to S. pneumoniae serotype 23F is to be≥0.5 (clinical limit for non-inferiority).|Adjusted GMC ratio|1.22|||||TWO_SIDED|97.5|1.0|1.5|||ANCOVA|GMC adjusted for BS sub cohorts;97.5% CI for adjusted GMC ratio(Ancova model:adjustment for BS sub cohorts-pooled variance)|To be able to conclude independently on primary objectives of Epoch 001 \& Epoch 002, a Bonferroni correction is used to test these primary objectives(1.25% one-sided for Epoch 001 and Epoch 002)|GMC ratios between HibCY and PedHIB groups for antibodies to S. pneumoniae serotype 23F concentrations one month after the fourth dose||1.50|1.00|
72376530|NCT02880956|144261943|SUPERIORITY||Effect size/pooled SD|-0.01|STANDARD_DEVIATION|2.97|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
72376531|NCT02880956|144261943|SUPERIORITY||LS Mean of Difference|0.19|STANDARD_ERROR_OF_MEAN|0.412||0.649|TWO_SIDED|95.0|-0.622|0.997||The statistical model: MMSE change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||0.997|-0.622|0.649
72376532|NCT02880956|144261943|SUPERIORITY||Effect size/pooled SD|0.06|STANDARD_DEVIATION|2.95|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
72376533|NCT02880956|144261943|SUPERIORITY||LS Mean of Difference|-0.39|STANDARD_ERROR_OF_MEAN|0.423||0.358|TWO_SIDED|95.0|-1.22|0.443||The statistical model: MMSE change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||0.443|-1.220|0.358
72376534|NCT02880956|144261943|SUPERIORITY||Effect size/pooled SD|-0.13|STANDARD_DEVIATION|2.99|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
72376535|NCT02880956|144261943|SUPERIORITY||LS Mean of Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.539||0.859|TWO_SIDED|95.0|-1.155|0.963||The statistical model: MMSE change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||0.963|-1.155|0.859
72376536|NCT02880956|144261943|SUPERIORITY||Effect size/pooled SD|-0.03|STANDARD_DEVIATION|3.74|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
72376537|NCT02880956|144261943|SUPERIORITY||LS Mean of Difference|0.4|STANDARD_ERROR_OF_MEAN|0.529||0.455|TWO_SIDED|95.0|-0.644|1.437||The statistical model: MMSE change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||1.437|-0.644|0.455
72376538|NCT02880956|144261943|SUPERIORITY||Effect size/pooled SD|0.11|STANDARD_DEVIATION|3.6|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
72376539|NCT02880956|144261943|SUPERIORITY||LS Mean of Difference|-0.52|STANDARD_ERROR_OF_MEAN|0.538||0.335|TWO_SIDED|95.0|-1.578|0.539||The statistical model: MMSE change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||0.539|-1.578|0.335
72376540|NCT02880956|144261943|SUPERIORITY||Effect size/pooled SD|-0.15|STANDARD_DEVIATION|3.57|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
72376541|NCT02880956|144261943|SUPERIORITY||LS Mean of Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.681||0.875|TWO_SIDED|95.0|-1.447|1.233||The statistical model: MMSE change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||1.233|-1.447|0.875
72376542|NCT02880956|144261943|SUPERIORITY||Effect size/pooled SD|-0.02|STANDARD_DEVIATION|4.57|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
72376543|NCT02880956|144261943|SUPERIORITY||LS Mean of Difference|0.25|STANDARD_ERROR_OF_MEAN|0.668||0.712|TWO_SIDED|95.0|-1.068|1.561||The statistical model: MMSE change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||1.561|-1.068|0.712
72376544|NCT02880956|144261943|SUPERIORITY||Effect size/pooled SD|0.05|STANDARD_DEVIATION|4.62|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
72376545|NCT02880956|144261943|SUPERIORITY||LS Mean of Difference|-0.76|STANDARD_ERROR_OF_MEAN|0.687||0.269|TWO_SIDED|95.0|-2.112|0.59||The statistical model: MMSE change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||0.590|-2.112|0.269
72376546|NCT02880956|144261943|SUPERIORITY||Effect size/pooled SD|-0.16|STANDARD_DEVIATION|4.78|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
72376547|NCT02880956|144261944|SUPERIORITY||LS Mean of Difference|0.03|STANDARD_ERROR_OF_MEAN|0.785||0.966|TWO_SIDED|95.0|-1.509|1.577||The statistical model: NPI change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||1.577|-1.509|0.966
72376548|NCT02880956|144261944|SUPERIORITY||Effect size/pooled SD|-0.01|STANDARD_DEVIATION|6.32|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
72376549|NCT02880956|144261944|SUPERIORITY||LS Mean of Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.775||0.874|TWO_SIDED|95.0|-1.646|1.4||The statistical model: NPI change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||1.400|-1.646|0.874
72376550|NCT02880956|144261944|SUPERIORITY||Effect size/pooled SD|0.02|STANDARD_DEVIATION|5.89|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
72376551|NCT02880956|144261944|SUPERIORITY||LS Mean of Difference|0.99|STANDARD_ERROR_OF_MEAN|0.794||0.213|TWO_SIDED|95.0|-0.572|2.551||The statistical model: NPI change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||2.551|-0.572|0.213
72376552|NCT02880956|144261944|SUPERIORITY||Effect size/pooled SD|-0.15|STANDARD_DEVIATION|6.67|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
72376553|NCT02880956|144261944|SUPERIORITY||LS Mean of Difference|0.88|STANDARD_ERROR_OF_MEAN|0.695||0.208|TWO_SIDED|95.0|-0.49|2.242||The statistical model: NPI change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||2.242|-0.490|0.208
72493924|NCT02653768|144516714|OTHER|As noted above, a statistical test was not specified at this time point. Rather, the data for all time points were included in the model and are presented here descriptively.|Mean Difference (Final Values)|-5.1|||||TWO_SIDED|95.0|-8.2|-2.0||||||This analysis of between-group difference in change from baseline to 3-month follow-up. We have not included a p-value because there was no pre-specified hypothesis for this time point. Rather, these are additional data obtained from the overall model, for which the 9-month time point was primary and included a pre-specified hypothesis.||-2.0|-8.2|
72504982|NCT01462292|144541163|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1305.46||||0.439|TWO_SIDED|95.0|-4668.41|2057.48||No adjustment for multiplicity was made, so p-values should not be used to make conclusions with regards to statistical significance|Mixed Model Repeated Measures|Model included terms for treatment, visit, treatment by visit, center grouping, baseline and baseline by visit||Treatment difference: Placebo Vs GSK2402968 6 mg, Week 24||2057.48|-4668.41|0.439
72376554|NCT02880956|144261944|SUPERIORITY||Effect size/pooled SD|-0.17|STANDARD_DEVIATION|5.26|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
72376555|NCT02880956|144261944|SUPERIORITY||LS Mean of Difference|1.03|STANDARD_ERROR_OF_MEAN|0.68||0.131|TWO_SIDED|95.0|-0.307|2.365||The statistical model: NPI change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||2.365|-0.307|0.131
72376556|NCT02880956|144261944|SUPERIORITY||Effect size/pooled SD|-0.18|STANDARD_DEVIATION|5.57|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
72376557|NCT02880956|144261944|SUPERIORITY||LS Mean of Difference|1.35|STANDARD_ERROR_OF_MEAN|0.695||0.052|TWO_SIDED|95.0|-0.014|2.719||The statistical model: NPI change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||2.719|-0.014|0.052
72376558|NCT02880956|144261944|SUPERIORITY||Effect size/pooled SD|-0.24|STANDARD_DEVIATION|5.55|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
72556121|NCT03261167|144643433|OTHER||Adjusted rate difference|-0.1|||||TWO_SIDED|95.0|-17.7|17.4|||||Week 12, Finger flexion. Analysis was based on the Mantel-Haenszel method using Baseline MAS score of the elbow flexors.|||17.4|-17.7|
72376559|NCT02880956|144261944|SUPERIORITY||LS Mean of Difference|0.18|STANDARD_ERROR_OF_MEAN|1.062||0.866|TWO_SIDED|95.0|-1.908|2.268||The statistical model: NPI change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||2.268|-1.908|0.866
72376560|NCT02880956|144261944|SUPERIORITY||Effect size/pooled SD|-0.03|STANDARD_DEVIATION|6.15|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
72376561|NCT02880956|144261944|SUPERIORITY||LS Mean of Difference|0.46|STANDARD_ERROR_OF_MEAN|1.048||0.66|TWO_SIDED|95.0|-1.599|2.523||The statistical model: NPI change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||2.523|-1.599|0.660
72376562|NCT02880956|144261944|SUPERIORITY||Effect size/pooled SD|-0.07|STANDARD_DEVIATION|6.94|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
72376563|NCT02880956|144261944|SUPERIORITY||LS Mean of Difference|1.91|STANDARD_ERROR_OF_MEAN|1.062||0.074|TWO_SIDED|95.0|-0.184|3.995||The statistical model: NPI change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||3.995|-0.184|0.074
72376564|NCT02880956|144261944|SUPERIORITY||Effect size/pooled SD|-0.22|STANDARD_DEVIATION|8.65|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
72376565|NCT02880956|144261944|SUPERIORITY||LS Mean of Difference|-0.36|STANDARD_ERROR_OF_MEAN|1.111||0.747|TWO_SIDED|95.0|-2.545|1.828||The statistical model: NPI change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||1.828|-2.545|0.747
72376566|NCT02880956|144261944|SUPERIORITY||Effect size/pooled SD|0.04|STANDARD_DEVIATION|7.99|||TWO_SIDED|||||||||Week 96||||
72376567|NCT02880956|144261944|SUPERIORITY||LS Mean of Difference|0.15|STANDARD_ERROR_OF_MEAN|1.095||0.891|TWO_SIDED|95.0|-2.004|2.304||The statistical model: NPI change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||2.304|-2.004|0.891
72376568|NCT02880956|144261944|SUPERIORITY||Effect size/pooled SD|-0.02|STANDARD_DEVIATION|8.28|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
72376569|NCT02880956|144261944|SUPERIORITY||LS Mean of Difference|0.55|STANDARD_ERROR_OF_MEAN|1.12||0.621|TWO_SIDED|95.0|-1.65|2.759||The statistical model: NPI change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||2.759|-1.650|0.621
72376570|NCT02880956|144261944|SUPERIORITY||Effect size/pooled SD|-0.07|STANDARD_DEVIATION|8.19|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
72376571|NCT02880956|144261945|SUPERIORITY||LS Mean of Difference|0.03|STANDARD_ERROR_OF_MEAN|0.019||0.147|TWO_SIDED|95.0|-0.01|0.064||The statistical model: ADCOMS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.064|-0.010|0.147
72376572|NCT02880956|144261945|SUPERIORITY||Effect size/pooled SD|-0.2|STANDARD_DEVIATION|0.14|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
72376573|NCT02880956|144261945|SUPERIORITY||LS Mean of Difference|0.0|STANDARD_ERROR_OF_MEAN|0.018||0.795|TWO_SIDED|95.0|-0.041|0.031||The statistical model: ADCOMS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.031|-0.041|0.795
72376574|NCT02880956|144261945|SUPERIORITY||Effect size/pooled SD|0.12|STANDARD_DEVIATION|0.147|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
72376575|NCT02880956|144261945|SUPERIORITY||LS Mean of Difference|0.03|STANDARD_ERROR_OF_MEAN|0.019||0.095|TWO_SIDED|95.0|-0.006|0.069||The statistical model: ADCOMS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.069|-0.006|0.095
72376576|NCT02880956|144261945|SUPERIORITY||Effect size/pooled SD|-0.24|STANDARD_DEVIATION|0.13|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
72376577|NCT02880956|144261945|SUPERIORITY||LS Mean of Difference|0.02|STANDARD_ERROR_OF_MEAN|0.025||0.39|TWO_SIDED|95.0|-0.028|0.072||The statistical model: ADCOMS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||0.072|-0.028|0.390
72376578|NCT02880956|144261945|SUPERIORITY||Effect size/pooled SD|-0.12|STANDARD_DEVIATION|0.18|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
72376579|NCT02880956|144261945|SUPERIORITY||LS Mean of Difference|0.0|STANDARD_ERROR_OF_MEAN|0.025||0.898|TWO_SIDED|95.0|-0.052|0.045||The statistical model: ADCOMS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||0.045|-0.052|0.898
72556122|NCT03261167|144643433|OTHER||Adjusted rate difference|-9.9|||||TWO_SIDED|95.0|-26.4|6.5|||||Week 2, Thumb flexion. Analysis was based on the Mantel-Haenszel method using Baseline MAS score of the elbow flexors.|||6.5|-26.4|
72556123|NCT03261167|144643433|OTHER||Adjusted rate difference|-6.7|||||TWO_SIDED|95.0|-23.6|10.3|||||Week 4, Thumb flexion. Analysis was based on the Mantel-Haenszel method using Baseline MAS score of the elbow flexors.|||10.3|-23.6|
72376580|NCT02880956|144261945|SUPERIORITY||Effect size/pooled SD|0.02|STANDARD_DEVIATION|0.19|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
72376581|NCT02880956|144261945|SUPERIORITY||LS Mean of Difference|0.01|STANDARD_ERROR_OF_MEAN|0.026||0.8|TWO_SIDED|95.0|-0.044|0.057||The statistical model: ADCOMS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||0.057|-0.044|0.800
72376582|NCT02880956|144261945|SUPERIORITY||Effect size/pooled SD|-0.04|STANDARD_DEVIATION|0.18|||TWO_SIDED|||||||||Week 48||||
72376583|NCT02880956|144261945|SUPERIORITY||LS Mean of Difference|0.0|STANDARD_ERROR_OF_MEAN|0.033||0.977|TWO_SIDED|95.0|-0.066|0.064||The statistical model: ADCOMS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||0.064|-0.066|0.977
72376584|NCT02880956|144261945|SUPERIORITY||Effect size/pooled SD|0.0|STANDARD_DEVIATION|0.23|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
72376585|NCT02880956|144261945|SUPERIORITY||LS Mean of Difference|0.0|STANDARD_ERROR_OF_MEAN|0.032||0.99|TWO_SIDED|95.0|-0.063|0.064||The statistical model: ADCOMS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||0.064|-0.063|0.990
72376586|NCT02880956|144261945|SUPERIORITY||Effect size/pooled SD|0.0|STANDARD_DEVIATION|0.24|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
72376587|NCT02880956|144261945|SUPERIORITY||LS Mean of Difference|0.0|STANDARD_ERROR_OF_MEAN|0.033||0.944|TWO_SIDED|95.0|-0.063|0.067||The statistical model: ADCOMS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||0.067|-0.063|0.944
72376588|NCT02880956|144261945|SUPERIORITY||Effect size/pooled SD|-0.01|STANDARD_DEVIATION|0.23|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
72376589|NCT02880956|144261945|SUPERIORITY||LS Mean of Difference|0.0|STANDARD_ERROR_OF_MEAN|0.042||0.942|TWO_SIDED|95.0|-0.079|0.085||The statistical model: ADCOMS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||0.085|-0.079|0.942
72376590|NCT02880956|144261945|SUPERIORITY||Effect size/pooled SD|-0.01|STANDARD_DEVIATION|0.28|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
72376591|NCT02880956|144261945|SUPERIORITY||LS Mean of Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.041||0.876|TWO_SIDED|95.0|-0.087|0.074||The statistical model: ADCOMS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||0.074|-0.087|0.876
72376592|NCT02880956|144261945|SUPERIORITY||Effect size/pooled SD|0.02|STANDARD_DEVIATION|0.27|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
72556124|NCT03261167|144643433|OTHER||Adjusted rate difference|-1.5|||||TWO_SIDED|95.0|-18.8|15.7|||||Week 6, Thumb flexion. Analysis was based on the Mantel-Haenszel method using Baseline MAS score of the elbow flexors.|||15.7|-18.8|
72376593|NCT02880956|144261945|SUPERIORITY||LS Mean of Difference|0.06|STANDARD_ERROR_OF_MEAN|0.043||0.163|TWO_SIDED|95.0|-0.024|0.143||The statistical model: ADCOMS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||0.143|-0.024|0.163
72556125|NCT03261167|144643433|OTHER||Adjusted rate difference|-0.5|||||TWO_SIDED|95.0|-18.8|17.9|||||Week 12, Thumb flexion. Analysis was based on the Mantel-Haenszel method using Baseline MAS score of the elbow flexors.|||17.9|-18.8|
72376594|NCT02880956|144261945|SUPERIORITY||Effect size/pooled SD|-0.21|STANDARD_DEVIATION|0.28|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
72376595|NCT00830791|144261965|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.74||||0.325|TWO_SIDED|90.0|0.43|1.26|||ANCOVA||The mean square error on a log scale for this comparison was 0.322.|||1.26|0.43|0.325
72376596|NCT00830791|144261966|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.95||||0.718|TWO_SIDED|90.0|0.76|1.2|||ANCOVA||The mean square error on a log scale was 0.061 for this comparison.|||1.20|0.76|0.718
72376597|NCT00830791|144261967|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.63||||0.014|TWO_SIDED|90.0|1.21|2.2|||ANCOVA||The mean square error on a log scale was 0.104 for this comparison.|||2.20|1.21|0.014
72376598|NCT00830791|144261969|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.14||||0.505|TWO_SIDED|90.0|0.81|1.6|||ANCOVA||The mean square error on a log scale for this comparison was 0.133.|||1.60|0.81|0.505
72376599|NCT00830791|144261971|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.0|||||TWO_SIDED|90.0|0.0|0.5|||ANCOVA|||||0.50|0.00|
72376600|NCT00830791|144261972|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.0|||||TWO_SIDED|90.0|0.0|0.5|||ANCOVA|||||0.50|0.00|
72556126|NCT03261167|144643434|OTHER||Mean Difference (Net)|-0.48|||||TWO_SIDED|95.0|-0.75|-0.22|||||Week 2, Elbow flexion. Analysis method was MMRM with Treatment, Visit, Treatment by visit interation, Baseline, and Baseline by visit interaction as fixed effects.|||-0.22|-0.75|
72556127|NCT03261167|144643434|OTHER||Mean Difference (Net)|-0.42|||||TWO_SIDED|95.0|-0.71|-0.13|||||Week 4, Elbow flexion. Analysis method was MMRM with Treatment, Visit, Treatment by visit interation, Baseline, and Baseline by visit interaction as fixed effects.|||-0.13|-0.71|
72556128|NCT03261167|144643434|OTHER||Mean Difference (Net)|-0.37|||||TWO_SIDED|95.0|-0.71|-0.04|||||Week 6, Elbow flexion. Analysis method was MMRM with Treatment, Visit, Treatment by visit interation, Baseline, and Baseline by visit interaction as fixed effects.|||-0.04|-0.71|
72376601|NCT01527357|144261986|SUPERIORITY||||||<|0.0001|||||||Log Rank|||||||< 0.0001
72376602|NCT01527357|144261987|SUPERIORITY||||||<|0.0001|||||||Log Rank|||||||< 0.0001
72376603|NCT01527357|144261988|SUPERIORITY||||||<|0.0001|||||||Log Rank|||||||< 0.0001
72376604|NCT01527357|144261989|SUPERIORITY||||||<|0.0001|||||||Log Rank|||||||< 0.0001
72376605|NCT02446171|144261994|SUPERIORITY_OR_OTHER||Ratio#|98.89|||||TWO_SIDED|90.0|92.4|105.84|||ANOVA|The results are based on ANOVA of log transformed PK parameters with sequence, period, treatment, and subject nested within sequence as fixed effects.||||105.84|92.40|
72376606|NCT02446171|144261994|SUPERIORITY_OR_OTHER||Ratio#|100.04|||||TWO_SIDED|90.0|93.17|107.43|||ANOVA|The results are based on ANOVA of log transformed PK parameters with sequence, period, treatment, and subject nested within sequence as fixed effects.||||107.43|93.17|
72376607|NCT02446171|144261994|SUPERIORITY_OR_OTHER||Ratio#|94.37|||||TWO_SIDED|90.0|88.7|100.4|||ANOVA|The results are based on ANOVA of log transformed PK parameters with sequence, period, treatment, and subject nested within sequence as fixed effects.||||100.40|88.70|
72376608|NCT02446171|144261995|SUPERIORITY_OR_OTHER||Ratio#|98.79|||||TWO_SIDED|90.0|92.24|105.8|||ANOVA|The results are based on ANOVA of log transformed PK parameters with sequence, period, treatment, and subject nested within sequence as fixed effects.||||105.80|92.24|
72376609|NCT02446171|144261995|SUPERIORITY_OR_OTHER||Ratio#|100.44|||||TWO_SIDED|90.0|93.65|107.72|||ANOVA|The results are based on ANOVA of log transformed PK parameters with sequence, period, treatment, and subject nested within sequence as fixed effects.||||107.72|93.65|
72376610|NCT02446171|144261995|SUPERIORITY_OR_OTHER||Ratio#|94.83|||||TWO_SIDED|90.0|89.2|100.82|||ANOVA|The results are based on ANOVA of log transformed PK parameters with sequence, period, treatment, and subject nested within sequence as fixed effects.||||100.82|89.20|
72376611|NCT02446171|144261996|SUPERIORITY_OR_OTHER||Ratio#|97.05|||||TWO_SIDED|90.0|88.09|106.92|||ANOVA|The results are based on ANOVA of log transformed PK parameters with sequence, period, treatment, and subject nested within sequence as fixed effects.||||106.92|88.09|
72376612|NCT02446171|144261996|SUPERIORITY_OR_OTHER||Ratio#|100.56|||||TWO_SIDED|90.0|91.8|110.16|||ANOVA|The results are based on ANOVA of log transformed PK parameters with sequence, period, treatment, and subject nested within sequence as fixed effects.||||110.16|91.80|
72376613|NCT02446171|144261996|SUPERIORITY_OR_OTHER||Ratio#|102.5|||||TWO_SIDED|90.0|93.13|111.82|||ANOVA|The results are based on ANOVA of log transformed PK parameters with sequence, period, treatment, and subject nested within sequence as fixed effects.||||111.82|93.13|
72376614|NCT04531462|144262011|SUPERIORITY|Null hypothesis: Mean change from baseline in HbA1c after 52 weeks of treatment with empagliflozin 10 mg = mean change from baseline in HbA1c after 52 weeks of treatment with placebo.|Mean Difference (Net)|-0.57|||<|0.0001|TWO_SIDED|95.0|-0.78|-0.36||Threshold level for statistical significance: α = 0.05 .|Mixed Model Repeated Measures (MMRM)||Empagliflozin 10 mg- Placebo|Restricted maximum likelihood (REML)-based mixed model repeated measures (MMRM) which included fixed classification effects for treatment, gender, baseline renal function, visit and visit-by-treatment interaction, and a linear covariate for baseline HbA1c and age. An unstructured covariance structure was used to model the within patient errors. The Kenward-Roger approximation was used to estimate the denominator degrees of freedom.||-0.36|-0.78|<0.0001
72556129|NCT03261167|144643434|OTHER||Mean Difference (Net)|-0.27|||||TWO_SIDED|95.0|-0.51|-0.02|||||Week 12, Elbow flexion. Analysis method was MMRM with Treatment, Visit, Treatment by visit interation, Baseline, and Baseline by visit interaction as fixed effects.|||-0.02|-0.51|
72556130|NCT03261167|144643434|OTHER||Mean Difference (Net)|0.08|||||TWO_SIDED|95.0|-0.27|0.42|||||Week 2, Wrist flexion. Analysis method was MMRM with Treatment, Visit, Treatment by visit interation, Baseline, and Baseline by visit interaction as fixed effects.|||0.42|-0.27|
72376615|NCT04531462|144262012|OTHER||Mean Difference (Net)|-0.61||||0.231|TWO_SIDED|95.0|-1.61|0.39|||ANCOVA||Empagliflozin 10 mg- Placebo|Analysis of Covariance (ANCOVA) included baseline muscle mass, age, baseline glycated hemoglobin (HbA1c), baseline body mass index (BMI) as linear covariates and sex, treatment as fixed effects.||0.39|-1.61|0.2310
72376616|NCT04531462|144262013|OTHER||Mean Difference (Net)|-1.84|||<|0.0001|TWO_SIDED|95.0|-2.65|-1.04|||ANCOVA||Empagliflozin 10 mg- Placebo|Analysis of Covariance (ANCOVA) included baseline body fat measurement, age, baseline glycated hemoglobin (HbA1c), baseline body mass index (BMI) as linear covariates and sex, treatment as fixed effects.||-1.04|-2.65|<0.0001
72376617|NCT04531462|144262014|OTHER||Mean Difference (Net)|-0.53||||0.1632|TWO_SIDED|95.0|-1.28|0.22|||ANCOVA||Empagliflozin 10 mg- Placebo|Analysis of Covariance (ANCOVA) included baseline lean body mass, age, baseline glycated hemoglobin (HbA1c), baseline body mass index (BMI) as linear covariates and sex, treatment as fixed effects.||0.22|-1.28|0.1632
72376618|NCT04531462|144262015|OTHER||Mean Difference (Net)|-0.63||||0.0384|TWO_SIDED|95.0|-1.23|-0.03|||ANCOVA||Empagliflozin 10 mg- Placebo|Analysis of Covariance (ANCOVA) included baseline total body water, age, baseline glycated hemoglobin (HbA1c), baseline body mass index (BMI) as linear covariates and sex, treatment as fixed effects.||-0.03|-1.23|0.0384
72376619|NCT04531462|144262016|OTHER||Mean Difference (Net)|-0.03||||0.1975|TWO_SIDED|95.0|-0.07|0.01|||ANCOVA||Empagliflozin 10 mg- Placebo|Analysis of Covariance (ANCOVA) included baseline bone mineral content, age, baseline glycated hemoglobin (HbA1c), baseline body mass index (BMI) as linear covariates and sex, treatment as fixed effects.||0.01|-0.07|0.1975
72376620|NCT04531462|144262017|OTHER||Mean Difference (Net)|-0.081||||0.3725|TWO_SIDED|95.0|-0.259|0.098|||ANCOVA||Empagliflozin 10 mg- Placebo|Analysis of Covariance (ANCOVA) which included baseline skeletal muscle index, age, baseline glycated hemoglobin (HbA1c), baseline body mass index (BMI) as linear covariates and sex, treatment as fixed effects.||0.098|-0.259|0.3725
72376621|NCT04531462|144262018|OTHER||Mean Difference (Net)|-0.3||||0.4208|TWO_SIDED|95.0|-1.1|0.5|||ANCOVA||Empagliflozin 10 mg- Placebo|Analysis of Covariance (ANCOVA) included baseline grip strength, age, baseline glycated hemoglobin (HbA1c), baseline body mass index (BMI) as linear covariates and sex, treatment as fixed effects.||0.5|-1.1|0.4208
72376622|NCT04531462|144262019|OTHER||Mean Difference (Net)|0.0||||0.9267|TWO_SIDED|95.0|-1.0|0.9|||ANCOVA||Empagliflozin 10 mg- Placebo|Analysis of Covariance (ANCOVA) included baseline 5-time chair stand test, age, baseline glycated hemoglobin (HbA1c), baseline body mass index (BMI) as linear covariates and sex, treatment as fixed effects.||0.9|-1.0|0.9267
72376623|NCT04175509|144262022|SUPERIORITY|||||||0.378|||||||t-test, 2 sided|||||||.378
72376624|NCT04175509|144262023|SUPERIORITY|||||||0.753|||||||t-test, 2 sided|||||||.753
72376625|NCT04175509|144262024|SUPERIORITY|||||||0.3|||||||t-test, 2 sided|||||||0.30
72376626|NCT04175509|144262025|SUPERIORITY|||||||0.43|||||||t-test, 2 sided|||||||0.43
72376627|NCT04175509|144262026|SUPERIORITY|||||||0.61|||||||t-test, 2 sided|||||||0.61
72376628|NCT04175509|144262027|SUPERIORITY|||||||0.77|||||||t-test, 2 sided|||||||0.77
72376629|NCT04175509|144262028|SUPERIORITY|||||||0.48|||||||t-test, 2 sided|||||||0.48
72376630|NCT04175509|144262029|SUPERIORITY|||||||0.78|||||||t-test, 2 sided|||||||0.78
72376631|NCT03811093|144262069|SUPERIORITY||Mean Difference (Net)|2.036|||<|0.01|TWO_SIDED|95.0|1.243|2.828||p-value is calculated using SPSS.|t-test, 2 sided|||The null hypothesis states that in the population from where the sample was obtained there was no difference between the intervention (invisa-RED Elite) and placebo groups in the mean change in the primary outcome variable, i.e. Change in Body Fat Percentage.||2.828|1.243|<0.01
72376632|NCT03811093|144262069|OTHER|||||||0.2||||||The significance value has been Lilliefors corrected and represents the lower bound of the true significance.|Kolmogorov-Smirnov Test|||"A single sample Kolmogorov-Smirnov normality test was used to examine if variables are normally distributed for the population from which the trial groups are drawn.~The null hypothesis is that the distribution of Percent of Body Fat Lost or Gained is normal with mean -.83 and standard deviation 1.50218."||||0.20
72376633|NCT03811093|144262069|OTHER|||||||0.075|||||||Levene's Test for Equality of Variance|||To test that the trial participant's population variances are equal (or exhibit homogeneity of variance), a Levene's Test for Equality of Variance was conducted. It tests the null hypothesis that the population variances are equal (called homogeneity of variance or homoscedasticity). For this test if the resulting p-value of Levene's test is less than .05, the obtained differences in sample variances are unlikely to have occurred based on random sampling from a population with equal variances.||||0.075
72376634|NCT03811093|144262070|SUPERIORITY||Mean Difference (Net)|7.063|||<|0.01|TWO_SIDED|95.0|3.829|10.296||p-value is calculated using SPSS.|t-test, 2 sided|||Designed as a superiority trial with the aim of establishing whether the intervention was superior or inferior to a placebo in effectiveness as a therapy for change over time in measured body circumference. The null hypothesis states that in the population from where the sample was obtained there was no difference between the intervention (invisa-RED Elite) and placebo groups in the mean change in the primary outcome variable, i.e. measured body circumference.||10.296|3.829|<0.01
72376635|NCT03811093|144262070|OTHER|||||||0.2||||||The significance value has been Lilliefors corrected and represents the lower bound of the true significance.|Kolmogorov-Smirnov Test|||"A Kolmogorov-Smirnov normality test was used to examine if variables are normally distributed for the population from which the trial groups are drawn.~The null hypothesis is that the distribution of Total Inches Lost or Gained is normal with mean -7.136 and standard deviation 5.796."||||0.20
72376636|NCT03811093|144262070|OTHER|||||||0.44|||||||Levene's Test for Equality of Variance|||To test that the trial participant's population variances are equal (or exhibit homogeneity of variance), a Levene's Test for Equality of Variance was conducted. It tests the null hypothesis that the population variances are equal (called homogeneity of variance or homoscedasticity). For this test if the resulting p-value of Levene's test is less than .05, the obtained differences in sample variances are unlikely to have occurred based on random sampling from a population with equal variances.||||0.44
72376637|NCT03811093|144262071|SUPERIORITY||Mean Difference (Net)|4.4703|||<|0.01|TWO_SIDED|95.0|2.3372|6.6034||p-value is computed using SPSS.|t-test, 2 sided|||Designed as a superiority trial with the aim of establishing whether the intervention was superior or inferior to a placebo in effectiveness as a therapy for change in body fat, measured in pounds. The null hypothesis states that in the population from where the sample was obtained there was no difference between the intervention (invisa-RED Elite) and placebo groups in the mean change in the primary outcome variable, i.e. change in pounds of body fat.||6.6034|2.3372|<0.01
72376638|NCT03811093|144262071|OTHER|||||||0.2||||||The significance value has been Lilliefors corrected and represents the lower bound of the true significance.|Kolmogorov-Smirnov Test|||"A single sample Kolmogorov-Smirnov normality test was used to examine if variables are normally distributed for the population from which the trial groups are drawn.~The null hypothesis is that the distribution of the Weight of Body Fat Lost or Gained is normal with mean -2.49 and standard deviation 3.71209."||||.200
72376639|NCT03811093|144262071|OTHER|||||||0.438|||||||Levene's Test for Equality of Variance|||To test that the trial participant's population variances are equal (or exhibit homogeneity of variance), a Levene's Test for Equality of Variance was conducted. It tests the null hypothesis that the population variances are equal (called homogeneity of variance or homoscedasticity). For this test if the resulting p-value of Levene's test is less than .05, the obtained differences in sample variances are unlikely to have occurred based on random sampling from a population with equal variances.||||.438
72376640|NCT00464490|144262072|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED|||||P-value \<0.05 was considered significant|t-test, 2 sided|||H(0): Ventilator time (DG) = Ventilator time (CG)||||0.02
72376641|NCT00924170|144262117|SUPERIORITY||||||<|0.0001|||||||Kaplan Meier|||Published response duration of 15 patients with leukemic adult T cell leukemia treated with Alemtuzumab.||||<0.0001
72376642|NCT01203852|144262157|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-value for one sided t-test of mean change in blood pressure before and after treatment with metoprolol and chlorthalidone were \<0.0001.|t-test, 1 sided|||||||<0.0001
72376643|NCT01203852|144262158|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-value for one sided t-test for mean glucose change before and after treatment with chlorthalidone was \<0.0001.|t-test, 1 sided|||Mean glucose change after treatment with chlorthalidone||||<0.0001
72376644|NCT01203852|144262158|SUPERIORITY_OR_OTHER|||||||0.049|TWO_SIDED|||||P-value for one sided t-test for mean glucose change before and after treatment with metoprolol was 0.049.|t-test, 1 sided|||Mean glucose change after treatment with metoprolol||||0.049
72376645|NCT00247611|144262167|SUPERIORITY_OR_OTHER|||||||0.12||||||The p-value was not adjusted for multiple comparisons, and thresholds for significance were 0.05 alpha two tailed.|HLM|||For the ITT sample, the observed pattern of an increasing proportion of participants in the intervention arm reporting perfect adherence as time progressed from was associated with a p-value of 0.12, two-tailed alpha 0.05.||||0.12
72376646|NCT00247611|144262167|SUPERIORITY_OR_OTHER|||||||0.024||95.0||||The p-value was not adjusted for multiple comparisons, and thresholds for significance was 0.05 alpha, two tailed.|HLM|||For the on protocol sample, study arm was associated with perfect ACTG-assessed 3-day ARV adherence at p = 0.024, alpha two-tailed.||||0.024
72556131|NCT03261167|144643434|OTHER||Mean Difference (Net)|0.11|||||TWO_SIDED|95.0|-0.25|0.46|||||Week 4, Wrist flexion. Analysis method was MMRM with Treatment, Visit, Treatment by visit interation, Baseline, and Baseline by visit interaction as fixed effects.|||0.46|-0.25|
72556132|NCT03261167|144643434|OTHER||Mean Difference (Net)|-0.02|||||TWO_SIDED|95.0|-0.37|0.33|||||Week 6, Wrist flexion. Analysis method was MMRM with Treatment, Visit, Treatment by visit interation, Baseline, and Baseline by visit interaction as fixed effects.|||0.33|-0.37|
72556133|NCT03261167|144643434|OTHER||Mean Difference (Net)|0.09|||||TWO_SIDED|95.0|-0.19|0.38|||||Week 12, Wrist flexion. Analysis method was MMRM with Treatment, Visit, Treatment by visit interation, Baseline, and Baseline by visit interaction as fixed effects.|||0.38|-0.19|
72556134|NCT03261167|144643434|OTHER||Mean Difference (Net)|0.1|||||TWO_SIDED|95.0|-0.23|0.43|||||Week 2, Finger flexion. Analysis method was MMRM with Treatment, Visit, Treatment by visit interation, Baseline, and Baseline by visit interaction as fixed effects.|||0.43|-0.23|
72556135|NCT03261167|144643434|OTHER||Mean Difference (Net)|0.17|||||TWO_SIDED|95.0|-0.17|0.52|||||Week 4, Finger flexion. Analysis method was MMRM with Treatment, Visit, Treatment by visit interation, Baseline, and Baseline by visit interaction as fixed effects.|||0.52|-0.17|
72556136|NCT03261167|144643434|OTHER||Mean Difference (Net)|-0.14|||||TWO_SIDED|95.0|-0.2|0.48|||||Week 6, Finger flexion. Analysis method was MMRM with Treatment, Visit, Treatment by visit interaction, Baseline, and Baseline by visit interaction as fixed effects.|||0.48|-0.20|
72556137|NCT03261167|144643434|OTHER||Mean Difference (Net)|0.05|||||TWO_SIDED|95.0|-0.25|0.34|||||Week 12, Finger flexion. Analysis method was MMRM with Treatment, Visit, Treatment by visit interaction, Baseline, and Baseline by visit interaction as fixed effects.|||0.34|-0.25|
72556138|NCT03261167|144643434|OTHER||Mean Difference (Net)|0.28|||||TWO_SIDED|95.0|-0.08|0.63|||||Week 2, Thumb flexion. Analysis method was MMRM with Treatment, Visit, Treatment by visit interation, Baseline, and Baseline by visit interaction as fixed effects.|||0.63|-0.08|
72556139|NCT03261167|144643434|OTHER||Mean Difference (Net)|0.14|||||TWO_SIDED|95.0|-0.23|0.51|||||Week 4, Thumb flexion. Analysis method was MMRM with Treatment, Visit, Treatment by visit interation, Baseline, and Baseline by visit interaction as fixed effects.|||0.51|-0.23|
72556140|NCT03261167|144643434|OTHER||Mean Difference (Net)|0.03|||||TWO_SIDED|95.0|-0.33|0.38|||||Week 6, Thumb flexion. Analysis method was MMRM with Treatment, Visit, Treatment by visit interation, Baseline, and Baseline by visit interaction as fixed effects.|||0.38|-0.33|
72556141|NCT03261167|144643434|OTHER||Mean Difference (Net)|0.08|||||TWO_SIDED|95.0|-0.31|0.47|||||Week 12, Thumb flexion. Analysis method was MMRM with Treatment, Visit, Treatment by visit interation, Baseline, and Baseline by visit interaction as fixed effects.|||0.47|-0.31|
72556142|NCT03261167|144643435|OTHER||Mean Difference (Net)|-0.24|||||TWO_SIDED|95.0|-0.48|0.0|||||Week 2. Analysis method was MMRM with Treatment, Visit, Treatment by visit interaction, Baseline, and Baseline by visit interaction as fixed effects.|||0.00|-0.48|
72556143|NCT03261167|144643435|OTHER||Mean Difference (Net)|-0.16|||||TWO_SIDED|95.0|-0.42|0.09|||||Week 4. Analysis method was MMRM with Treatment, Visit, Treatment by visit interation, Baseline, and Baseline by visit interaction as fixed effects.|||0.09|-0.42|
72556144|NCT03261167|144643435|OTHER||Mean Difference (Net)|-0.15|||||TWO_SIDED|95.0|-0.37|0.08|||||Week 6. Analysis method was MMRM with Treatment, Visit, Treatment by visit interation, Baseline, and Baseline by visit interaction as fixed effects.|||0.08|-0.37|
72556145|NCT03261167|144643435|OTHER||Mean Difference (Net)|-0.28|||||TWO_SIDED|95.0|-0.52|-0.04|||||Week 12. Analysis method was MMRM with Treatment, Visit, Treatment by visit interation, Baseline, and Baseline by visit interaction as fixed effects.|||-0.04|-0.52|
72556146|NCT03364192|144643448|OTHER|Multilevel modeling adapted for multiple-baseline design comparing participant goal attainment before, during, and after peer-delivered Whole Health Coaching.|||||<|0.05|||||||Multilevel Modeling|||||||<0.05
72556147|NCT05133180|144643455|SUPERIORITY|The following null hypothesis is defined on this endpoint: the number of patients reaching a value of Schirmer I test (without anaesthesia) \>10mm/5min at week 4 in cenegermin (rhNGF) is lower or equal than control. The null hypothesis is rejected if the associated primary analysis p-value is lower than 0.025.|Odds Ratio (OR)|16.946|||<|0.001|TWO_SIDED|95.0|3.412|84.165||P-value of treatment variable from logistic regression model on the number of patients reaching a value of Schirmer I test (without anaesthesia) \>10mm/5min|Regression, Logistic|||It was analyzed by means of a logistic regression model adjusting by pre-defined baseline factors (treatment, gender, age class, baseline Schirmer I test value as fixed effects and site as random effect). For the imputation of missing data at week 4, a Multiple Imputation approach is adopted by performing a regression model with the baseline Schirmer I test value, gender, age class, and Schirmer I test at week 2 as explanatory variables and generating 200 datasets.||84.165|3.412|<0.001
72556148|NCT05133180|144643456|SUPERIORITY|The following null hypothesis is defined on this endpoint: the change from baseline (reduction) in the global SANDE score at week 12 in cenegermin is lower or equal than control. The null hypothesis is rejected if the associated primary analysis p-value is lower than 0.025.|adjusted mean difference|-4.561||||0.322|TWO_SIDED|95.0|-13.581|4.459||P-value of adjusted means difference between treatments from the ANCOVA model on change from baseline in the global SANDE score.|ANCOVA|||This endpoint was analyzed by means of an Analysis of Covariance with change from baseline in global SANDE Score at Week 12 as dependent variable, treatment, gender, age class, baseline global SANDE score as fixed effects and site as random effect. For missing data, Multiple Imputation approach is adopted by performing a regression model with the baseline global SANDE score, gender, age class, and intermediate global SANDE scores up to week 12 as explanatory variables and generating 200 datasets||4.459|-13.581|0.322
72556149|NCT05133180|144643457|SUPERIORITY|Analysis was based on a logistic regression with the number of patients reaching a value of Schirmer I test \>10mm/5min at week 8 as dependent variable, treatment, gender, age class and baseline Schirmer I test value as qualitative independent variables. Site was considered as random effects that vary randomly among patients.|Odds Ratio (OR)|15.95|||<|0.001|TWO_SIDED|95.0|3.091|82.31|||Regression, Logistic|||This key secondary endpoint was analyzed by means of a logistic regression model with the number of patients reaching a value of Schirmer I test \>10mm/5min at Week 8 as dependent variable, treatment, gender, age class and baseline Schirmer I test value as fixed effects and site as random effect.||82.310|3.091|<0.001
72376647|NCT00247611|144262168|SUPERIORITY_OR_OTHER||||||>|0.5||95.0||||No adjustments were made.|Generalized Linear Model (GLM)|||For the ITT or OP samples, the significance threshold between groups over time for differential increases in proportion with suppressed (undetectable) viral load was p \> 0.50. The study was underpowered to detect differences in Viral load.||||>0.50
72376648|NCT00247611|144262169|SUPERIORITY_OR_OTHER|||||||0.12||0.0||||The p-value was not adjusted for multiple comparisons and is reported as 0.12 at alpha 0.05 two tailed|HLM|||For the ITT sample (t=586) the observed pattern of an increasing proportion of participants in the intervention arm reporting perfect adherence as time progressed from baseline was associated with a p-value of 0.12, alpha 0.05 two-tailed.||||0.12
72376649|NCT00247611|144262169|SUPERIORITY_OR_OTHER|||||||0.12||95.0||||The p-value was not adjusted for multiple comparisons, and is reported as 0.12 at alpha 0.05 two tailed.|HLM|||For the on protocol sample the pattern of increased proportion of participants in the intervention arm reporting perfect adherence as time progressed from baseline was associated with a p-value of 0.12, alpha 0.05 two-tailed.||||0.12
72376650|NCT00247611|144262170|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||P-value for difference in unemployment rate between On Protocol (OP) sample, and participants excluded from on protocol analysis.||||<0.001
72376651|NCT00247611|144262170|SUPERIORITY_OR_OTHER||||||<|0.01||95.0|||||Chi-squared|||P-value for difference of participants on disability between On Protocol (OP) sample, and participants excluded from on protocol analysis.||||<0.01
72376652|NCT01587898|144262171|SUPERIORITY_OR_OTHER|||||||0.5888|||||||Mixed effects linear regression model|The modeled Hgb change from baseline over 4 weeks was derived using a random coefficient mixed effects linear regression model.||Subgroup: Baseline Hgb||||0.5888
72376653|NCT01587898|144262171|SUPERIORITY_OR_OTHER|||||||0.66||95.0|||||Mixed effects linear regression model|The modeled Hgb change from baseline over 4 weeks was derived using a random coefficient mixed effects linear regression model.||Subgroup: Baseline Weight||||0.6600
72376654|NCT01587898|144262171|SUPERIORITY_OR_OTHER|||||||0.7999|||||||Mixed effects linear regression model|The modeled Hgb change from baseline over 4 weeks was derived using a random coefficient mixed effects linear regression model.||Subgroup: Baseline estimated glomerular filtration rate (eGFR)||||0.7999
72376655|NCT01587898|144262171|SUPERIORITY_OR_OTHER|||||||0.2092|||||||Mixed effects linear regression model|The modeled Hgb change from baseline over 4 weeks was derived using a random coefficient mixed effects linear regression model.||Covariate: Ethnicity||||0.2092
72376656|NCT01587898|144262171|SUPERIORITY_OR_OTHER|||||||0.9996||95.0|||||Mixed effects linear regression model|The modeled Hgb change from baseline over 4 weeks was derived using a random coefficient mixed effects linear regression model.||Covariate: Geographic Ancestry||||0.9996
72376657|NCT01587898|144262171|SUPERIORITY_OR_OTHER|||||||0.7002|||||||Mixed effects linear regression model|The modeled Hgb change from baseline over 4 weeks was derived using a random coefficient mixed effects linear regression model.||Covariate: Sex||||0.7002
72376658|NCT01587898|144262171|SUPERIORITY_OR_OTHER|||||||0.5536||95.0|||||Mixed effects linear regression model|The modeled Hgb change from baseline over 4 weeks was derived using a random coefficient mixed effects linear regression model.||Covariate: Age||||0.5536
72376659|NCT01587898|144262171|SUPERIORITY_OR_OTHER|||||||0.0085||95.0|||||Mixed effects linear regression model|The modeled Hgb change from baseline over 4 weeks was derived using a random coefficient mixed effects linear regression model.||Co-administration with food||||0.0085
72433563|NCT00984282|144380301|SUPERIORITY_OR_OTHER||||||<|0.0001||||||stratified by age group (\< 60 years, \>= 60 years) and region (Europe, North-America, Asia)|Log Rank|||The two treatment groups were compared using a stratified one-sided log rank test with an overall alpha of 0.01 stratified by age group and region. The null hypothesis that both treatment arms have the same PFS distribution will be tested against the alternative hypothesis that the distribution of PFS times in the sorafenib arm is different from the control arm according to the Lehmann alternative, which is equivalent to the assumption of proportional hazards of the treatment arms.||||<0.0001
72433564|NCT00984282|144380301|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.587|||||TWO_SIDED|95.0|0.454|0.758|||Regression, Cox|stratified by age group and region||||0.758|0.454|
72433565|NCT00984282|144380302|SUPERIORITY_OR_OTHER|||||||0.2892|||||||Log Rank|stratified by age group and region||||||0.2892
72376660|NCT01587898|144262171|SUPERIORITY_OR_OTHER|||||||0.0021||95.0|||||Mixed effects linear regression model|The modeled Hgb change from baseline over 4 weeks was derived using a random coefficient mixed effects linear regression model.||Covariate: Diabetic||||0.0021
72376661|NCT01587898|144262171|SUPERIORITY_OR_OTHER|||||||0.2194||95.0|||||Mixed effects linear regression model|The modeled Hgb change from baseline over 4 weeks was derived using a random coefficient mixed effects linear regression model.||Covariate: Region||||0.2194
72376662|NCT01903252|144262217|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority, pre-defined non-inferiority margin 10% A two-sided 95% confidence interval about the difference in proportions was constructed. If the lower limit of the confidence interval was no less than -10% it would be concluded that the test product is non-inferior to the comparator.|Risk Difference (RD)|-2.2||||0.005|TWO_SIDED|95.0|-8.1|3.8|||Non-inferiority|||If the lower limit of the confidence interval was no less than -10% it would be concluded that the test product is non-inferior to the comparator.||3.8|-8.1|0.005
72376663|NCT01903252|144262218|SUPERIORITY_OR_OTHER||Percentag|75.3|||||TWO_SIDED|95.0|69.4|80.6||||||||80.6|69.4|
72376664|NCT01903252|144262220|NON_INFERIORITY_OR_EQUIVALENCE|non-inferiority|Risk Difference (RD)|-2.1|||<|0.001|TWO_SIDED|95.0|-6.5|2.2|||Non-inferiority|||||2.2|-6.5|<0.001
72376665|NCT01903252|144262221|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority|Risk Difference (RD)|-3.1||||0.026|TWO_SIDED|95.0|-10.1|3.9|||Non-inferiority|||||3.9|-10.1|0.026
72376666|NCT01903252|144262222|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority|Risk Difference (RD)|-4.8||||0.048|TWO_SIDED|95.0|-10.9|1.4|||Non-inferiority|||||1.4|-10.9|0.048
72376667|NCT01903252|144262223|NON_INFERIORITY_OR_EQUIVALENCE|Non-Inferiority|Risk Difference (RD)|-3.9||||0.042|TWO_SIDED|95.0|-10.8|3.1|||Non-inferiortiy|||||3.1|-10.8|0.042
72376668|NCT01903252|144262224|NON_INFERIORITY|Non-Inferiority|Risk Difference (RD)|-4.2||||0.048|TWO_SIDED|95.0|-11.0|2.7|||Non-inferiority|||||2.7|-11.0|0.048
72376669|NCT01903252|144262225|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority|Risk Difference (RD)|-5.3||||0.068|TWO_SIDED|95.0|-11.5|0.9|||Non-inferiority|||||0.9|-11.5|0.068
72433566|NCT00984282|144380302|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.928|||||TWO_SIDED|95.0|0.713|1.208|||Regression, Cox|stratified by age group and region||||1.208|0.713|
72618389|NCT01292473|144767754|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-2.01||||0.0603|TWO_SIDED|95.0|-4.11|0.09||Refer to the Type-I error control plan. The p-value was not evaluated for statistical significance in accordance with the Type I error control plan provided in the Detailed Description.|ANCOVA|Covariates included in the analysis were baseline weekly number of hives (\< median vs ≥ median) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis is that there is no difference between the placebo and omalizumab 75 mg groups.||0.09|-4.11|0.0603
72618390|NCT01292473|144767754|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-4.51|||<|0.0001|TWO_SIDED|95.0|-6.65|-2.36||Refer to the Type-I error control plan.|ANCOVA|Covariates included in the analysis were baseline weekly number of hives (\< median vs ≥ median) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis is that there is no difference between the placebo and omalizumab 150 mg groups.||-2.36|-6.65|<0.0001
72618391|NCT01292473|144767754|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-7.09|||<|0.0001|TWO_SIDED|95.0|-9.26|-4.93||Refer to the Type-I error control plan.|ANCOVA|Covariates included in the analysis were baseline weekly number of hives (\< median vs ≥ median) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis is that there is no difference between the placebo and omalizumab 300 mg groups.||-4.93|-9.26|<0.0001
72618392|NCT01292473|144767755|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.43||||0.0478|TWO_SIDED|95.0|1.0|2.05||Refer to the Type-I error control plan. The p-value was not evaluated for statistical significance in accordance with the Type I error control plan provided in the Detailed Description.|Cox proportional hazards model|Covariates included in the analysis were baseline weekly itch severity score (\< 13 vs ≥ 13) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis is that there is no difference between Placebo and Omalizumab 75 mg.||2.05|1.00|0.0478
72618393|NCT01292473|144767755|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.59||||0.0101|TWO_SIDED|95.0|1.12|2.26||Refer to the Type-I error control plan.|Cox proportional hazards model|Covariates included in the analysis were baseline weekly itch severity score (\< 13 vs ≥ 13) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis is that there is no difference between the placebo and omalizumab 150 mg groups.||2.26|1.12|0.0101
72618394|NCT01292473|144767755|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.12|||<|0.0001|TWO_SIDED|95.0|1.48|3.03||Refer to the Type-I error control plan.|Cox proportional hazards model|Covariates included in the analysis were baseline weekly itch severity score (\< 13 vs ≥ 13) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis is that there is no difference between placebo and omalizumab 300 mg groups.||3.03|1.48|<0.0001
72618395|NCT01292473|144767756|SUPERIORITY_OR_OTHER|||||||0.3419||||||Refer to the Type-I error control plan. The p-value was not evaluated for statistical significance in accordance with the Type I error control plan provided in the Detailed Description.|Cochran-Mantel-Haenszel|Covariates included in the analysis were baseline UAS7 (\< median vs ≥ median) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis is that there is no difference between the placebo and omalizumab 75 mg groups.||||0.3419
72618396|NCT01292473|144767756|SUPERIORITY_OR_OTHER|||||||0.001||||||Refer to the Type-I error control plan.|Cochran-Mantel-Haenszel|Covariates included in the analysis were baseline UAS7 (\< median vs ≥ median) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis is that there is no difference between the placebo and omalizumab 150 mg groups.||||0.0010
72618397|NCT01292473|144767756|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Refer to the Type-I error control plan.|Cochran-Mantel-Haenszel|Covariates included in the analysis were baseline UAS7 (\< median vs ≥ median) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis is that there is no difference between placebo and omalizumab 300 mg groups.||||<0.0001
72618398|NCT01292473|144767757|SUPERIORITY_OR_OTHER|||||||0.4366||||||Refer to the Type-I error control plan. The p-value was not evaluated for statistical significance in accordance with the Type I error control plan provided in the Detailed Description.|Cochran-Mantel-Haenszel|Covariates included in the analysis were baseline weekly itch severity score (\< 13 vs ≥ 13) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis is that there is no difference between the placebo and omalizumab 75 mg groups.||||0.4366
72618399|NCT01292473|144767757|SUPERIORITY_OR_OTHER|||||||0.0045||||||Refer to the Type-I error control plan.|Cochran-Mantel-Haenszel|Covariates included in the analysis were baseline weekly itch severity score (\< 13 vs ≥ 13) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis is that there is no difference between the placebo and omalizumab 150 mg groups.||||0.0045
72618400|NCT01292473|144767757|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Refer to the Type-I error control plan.|Cochran-Mantel-Haenszel|Covariates included in the analysis were baseline weekly itch severity score (\< 13 vs ≥ 13) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis is that there is no difference between the placebo and omalizumab 300 mg groups.||||<0.0001
72618401|NCT01292473|144767758|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-2.48||||0.0082|TWO_SIDED|95.0|-4.32|-0.65||Refer to the Type-I error control plan. The p-value was not evaluated for statistical significance in accordance with the Type I error control plan provided in the Detailed Description.|ANCOVA|Covariates included in the analysis were baseline weekly size of largest hive score (\< median vs ≥ median) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis is that there is no difference between the placebo and omalizumab 75 mg groups.||-0.65|-4.32|0.0082
72618402|NCT01292473|144767758|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-3.76|||<|0.0001|TWO_SIDED|95.0|-5.61|-1.9||Refer to the Type-I error control plan.|ANCOVA|Covariates included in the analysis were baseline weekly size of largest hive score (\< median vs ≥ median) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis is that there is no difference between the placebo and omalizumab 150 mg groups.||-1.90|-5.61|<0.0001
72618403|NCT01292473|144767758|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-7.15|||<|0.0001|TWO_SIDED|95.0|-9.03|-5.27||Refer to the Type-I error control plan.|ANCOVA|Covariates included in the analysis were baseline weekly size of largest hive score (\< median vs ≥ median) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis is that there is no difference between the placebo and the omalizumab 300 mg groups.||-5.27|-9.03|<0.0001
72376670|NCT01903252|144262226|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority|Risk Difference (RD)|-2.9||||0.021|TWO_SIDED|95.0|-9.8|4.0|||Non-inferiortiy|||||4.0|-9.8|0.021
72376671|NCT01903252|144262227|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority|Risk Difference (RD)|-3.4||||0.031|TWO_SIDED|95.0|-10.3|3.7|||Non-inferiortiy|||||3.7|-10.3|0.031
72376672|NCT01903252|144262228|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority|Risk Difference (RD)|-3.7||||0.013|TWO_SIDED|95.0|-9.2|1.8|||Non-inferiority|||||1.8|-9.2|0.013
72376673|NCT01903252|144262229|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority|Risk Difference (RD)|-3.9||||0.042|TWO_SIDED|95.0|-10.8|3.0|||Non-inferiority|||||3.0|-10.8|0.042
72376674|NCT01903252|144262230|OTHER||Mean Difference (Net)|-0.1||||0.557|TWO_SIDED|95.0|-0.5|0.3|||t-test, 2 sided|||||0.3|-0.5|0.557
72376675|NCT01903252|144262231|OTHER||Mean Difference (Net)|0.0||||0.987|TWO_SIDED|95.0|-0.3|0.3|||t-test, 2 sided|||||0.3|-0.3|0.987
72376676|NCT01903252|144262232|OTHER||Mean Difference (Net)|0.1||||0.455|TWO_SIDED|95.0|-0.1|0.2|||t-test, 2 sided||The result of the mean difference is not corresponding to the values in the table due to rounding as specified in the Statistical Analysis Plan (SAP).|||0.2|-0.1|0.455
72376677|NCT01903252|144262233|OTHER||Mean Difference (Net)|0.0||||0.937|TWO_SIDED|95.0|-0.1|0.1|||t-test, 2 sided||The apparent difference between the values in the table and the mean difference is due to rounding as defined in the SAP.|||0.1|-0.1|0.937
72376678|NCT01903252|144262234|OTHER||Mean Difference (Net)|-0.1||||0.357|TWO_SIDED|95.0|-0.2|0.1|||t-test, 2 sided|||||0.1|-0.2|0.357
72376679|NCT01903252|144262235|OTHER||Mean Difference (Net)|-0.1||||0.099|TWO_SIDED|95.0|-0.2|0.0|||t-test, 2 sided|||||0.0|-0.2|0.099
72376680|NCT01903252|144262236|OTHER||Percentage|21.8|||||TWO_SIDED|95.0|16.8|27.5||||||||27.5|16.8|
72376681|NCT01903252|144262237|OTHER||Percentage|60.1|||||TWO_SIDED|95.0|53.6|66.3||||||||66.3|53.6|
72556150|NCT05133180|144643458|SUPERIORITY||adjusted mean difference|-2.753||||0.572|TWO_SIDED|95.0|-12.303|6.798||P-value of adjusted means difference between treatments from the ANCOVA model on change from baseline in SANDE score for frequency at Week 12.|ANCOVA regression model|||This endpoint was analyzed by means of an ANCOVA adjusting by pre-defined baseline factors (treatment, gender, age class, baseline SANDE score for severity as fixed effects and site as random effect).||6.798|-12.303|0.572
72556151|NCT05133180|144643459|SUPERIORITY||adjusted mean difference|-4.732||||0.307|TWO_SIDED|95.0|-13.819|4.354||P-value of adjusted means difference between treatments from the ANCOVA model on change from baseline in SANDE score for severity at Week 12.|ANCOVA regression model|||This endpoint was analyzed by means of an ANCOVA adjusting by pre-defined baseline factors (treatment, gender, age class, baseline SANDE score for severity as fixed effects and site as random effect).||4.354|-13.819|0.307
72556152|NCT05133180|144643460|SUPERIORITY|"Changes from baseline in each IDEEL modules scale score was analyzed using a mixed model for repeated measures (MMRM) adjusting by gender, age class, IDEEL module baseline value, treatment, visit and treatment by visit interaction. Subject was considered as a random effect. The covariance matrix used was unstructured. Comparisons vs vehicle TID was provided using least square means at each visit and overall."|least square mean difference|2.16||||0.468|TWO_SIDED|95.0|-3.668|7.988||P-value of Least Square (LS) means difference between treatments from the MMRM on change from baseline in IDEEL Quality of Life Module (Daily Activities) at Week 4|MMRM|||Impact on daily activities at week 4.||7.988|-3.668|0.468
72556153|NCT05133180|144643460|SUPERIORITY|"Changes from baseline in each IDEEL modules scale score was analyzed using a mixed model for repeated measures (MMRM) adjusting by gender, age class, IDEEL module baseline value, treatment, visit and treatment by visit interaction. Subject was considered as a random effect. The covariance matrix used was unstructured. Comparisons vs vehicle TID was provided using least square means at each visit and overall."|least square mean difference|2.431||||0.492|TWO_SIDED|95.0|-4.5|9.362||P-value of LS means difference between treatments from the MMRM on change from baseline in IDEEL Quality of Life Module (Emotional Impact) at Week 4.|MMRM|||Emotional Impact due to Dry eye at week 4.||9.362|-4.500|0.492
72556154|NCT05133180|144643460|SUPERIORITY|"Changes from baseline in each IDEEL modules scale score was analyzed using a mixed model for repeated measures (MMRM). Analyses included the fixed, categorical effects of treatment, visit and treatment by visit interaction. Subject was considered as a random effect. The covariance matrix used was unstructured. Comparisons vs vehicle TID was provided using least square means at each visit and overall. Missing data will be imputed according to the questionnaire manuals"|LS means difference|3.3||||0.51|TWO_SIDED|95.0|-6.511|13.111||P-value of LS means difference between treatments from the MMRM on change from baseline in IDEEL Quality of Life Module (Impact on Work) at Week 4.|MMRM|||Impact on Work due to Dry Eye at week 4.||13.111|-6.511|0.510
72556155|NCT05133180|144643460|SUPERIORITY|"Changes from baseline in each IDEEL modules scale score was analyzed using a mixed model for repeated measures (MMRM) adjusting by gender, age class, IDEEL module baseline value, treatment, visit and treatment by visit interaction. Subject was considered as a random effect. The covariance matrix used was unstructured. Comparisons vs vehicle TID was provided using least square means at each visit and overall."|Least square mean difference|4.078||||0.268|TWO_SIDED|95.0|-3.142|11.299||P-value of LS means difference between treatments from the MMRM on change from baseline in IDEEL Quality of Life Module (Daily Activities) at Week 12.|MMRM|||Quality of life - Impact on daily activities - Week 12||11.299|-3.142|0.268
72556156|NCT05133180|144643460|SUPERIORITY|"Changes from baseline in each IDEEL modules scale score was analyzed using a mixed model for repeated measures (MMRM) adjusting by gender, age class, IDEEL module baseline value, treatment, visit and treatment by visit interaction. Subject was considered as a random effect. The covariance matrix used was unstructured. Comparisons vs vehicle TID was provided using least square means at each visit and overall"|least square mean difference|5.55||||0.227|TWO_SIDED|95.0|-3.462|14.562||P-value of LS means difference between treatments from the MMRM on change from baseline in IDEEL Quality of Life Module (Emotional Impact) at Week 12.|MMRM|||Quality of life - Emotional Impact due to Dry eye - Week 12||14.562|-3.462|0.227
72556157|NCT05133180|144643460|SUPERIORITY|"Changes from baseline in each IDEEL modules scale score was analyzed using a mixed model for repeated measures (MMRM) adjusting by gender, age class, IDEEL module baseline value, treatment, visit and treatment by visit interaction. Subject was considered as a random effect. The covariance matrix used was unstructured. Comparisons vs vehicle TID was provided using least square means at each visit and overall."|least square mean difference|3.475||||0.501|TWO_SIDED|95.0|-6.651|13.601||P-value of LS means difference between treatments from the MMRM on change from baseline in IDEEL Quality of Life Module (Impact on Work) at Week 12.|MMRM|||Quality of life - Impact on Work due to Dry Eye - Week 12||13.601|-6.651|0.501
72556158|NCT05133180|144643461|SUPERIORITY|"Changes from baseline in each IDEEL modules scale score was analyzed using a mixed model for repeated measures (MMRM) adjusting by gender, age class, IDEEL module baseline value, treatment, visit and treatment by visit interaction. Subject was considered as a random effect. The covariance matrix used was unstructured. Comparisons vs vehicle TID was provided using least square means at each visit and overall."|least square mean difference|-0.549||||0.924|TWO_SIDED|95.0|-11.82|10.723||P-value of LS means difference between treatments from the MMRM on change from baseline in IDEEL Treatment Satisfaction \& Bother module (Satisfaction with Treatment Effectiveness) at Week 4.|MMRM|||IDEEL Treatment satisfaction \& Bother Module Satisfaction with Treatment Effectiveness - week 4||10.723|-11.820|0.924
72556159|NCT05133180|144643461|SUPERIORITY|"Changes from baseline in each IDEEL modules scale score was analyzed using a mixed model for repeated measures (MMRM) adjusting by gender, age class, IDEEL module baseline value, treatment, visit and treatment by visit interaction. Subject was considered as a random effect. The covariance matrix used was unstructured. Comparisons vs vehicle TID was provided using least square means at each visit and overall."|least square mean difference|1.072||||0.745|TWO_SIDED|95.0|-5.398|7.542||P-value of LS means difference between treatments from the MMRM on change from baseline in IDEEL Treatment Satisfaction \& Bother module (Treatment- Related Bother / Inconvenience) at Week 4.|MMRM|||IDEEL Treatment satisfaction \& Bother Module - Treatment- Related Bother / Inconvenience - week 4||7.542|-5.398|0.745
72556160|NCT05133180|144643461|SUPERIORITY|"Changes from baseline in each IDEEL modules scale score was analyzed using a mixed model for repeated measures (MMRM)adjusting by gender, age class, IDEEL module baseline value, treatment, visit and treatment by visit interaction. Subject was considered as a random effect. The covariance matrix used was unstructured. Comparisons vs vehicle TID was provided using least square means at each visit and overall."|least square mean difference|-4.206||||0.467|TWO_SIDED|95.0|-15.53|7.118||P-value of LS means difference between treatments from the MMRM on change from baseline in IDEEL Treatment Satisfaction \& Bother module (Satisfaction with Treatment Effectiveness) at Week 12.|MMRM|||IDEEL Treatment satisfaction \& Bother Module - Satisfaction with Treatment Effectiveness - week 12||7.118|-15.530|0.467
72556161|NCT05133180|144643461|SUPERIORITY|"Changes from baseline in each IDEEL modules scale score was analyzed using a mixed model for repeated measures (MMRM)adjusting by gender, age class, IDEEL module baseline value, treatment, visit and treatment by visit interaction. Subject was considered as a random effect. The covariance matrix used was unstructured. Comparisons vs vehicle TID was provided using least square means at each visit and overall."|least square mean difference|2.244||||0.564|TWO_SIDED|95.0|-5.387|9.874||P-value of LS means difference between treatments from the MMRM on change from baseline in IDEEL Treatment Satisfaction \& Bother module (Treatment- Related Bother / Inconvenience) at Week 12.|MMRM|||IDEEL Treatment satisfaction \& Bother Module - Treatment- Related Bother / Inconvenience - week 12||9.874|-5.387|0.564
72556162|NCT05133180|144643462|SUPERIORITY|"Changes from baseline in each IDEEL modules scale score was analyzed using a mixed model for repeated measures (MMRM) adjusting by gender, age class, IDEEL module baseline value, treatment, visit and treatment by visit interaction. Subject was considered as a random effect. The covariance matrix used was unstructured. Comparisons vs vehicle TID was provided using least square means at each visit and overall."|least square mean difference|-0.805||||0.802|TWO_SIDED|95.0|-7.086|5.476||P-value of LS means difference between treatments from the MMRM on change from baseline in IDEEL Symptom Bother Module at Week 4.|MMRM|||IDEEL - Symptom Bother module - week 4||5.476|-7.086|0.802
72556163|NCT05133180|144643462|SUPERIORITY|"Changes from baseline in each IDEEL modules scale score was analyzed using a mixed model for repeated measures (MMRM) adjusting by gender, age class, IDEEL module baseline value, treatment, visit and treatment by visit interaction. Subject was considered as a random effect. The covariance matrix used was unstructured. Comparisons vs vehicle TID was provided using least square means at each visit and overall."|least square mean difference|-8.789||||0.019|TWO_SIDED|95.0|-16.16|-1.418||P-value of LS means difference between treatments from the MMRM on change from baseline in IDEEL Symptom Bother Module at Week 12.|MMRM|||IDEEL - Symptom Bother module - week 12||-1.418|-16.160|0.019
72556164|NCT05133180|144643463|SUPERIORITY||least square mean difference|-1.518||||0.045|TWO_SIDED|95.0|-3.005|-0.031||P-value of LS means difference between treatments from the MMRM on change from baseline in Cornea and conjunctiva vital staining with fluorescein NEI scale at Week 4.|MMRM|||Herein Week 4 was considered. The change from baseline in Cornea and conjunctiva vital staining with fluorescein NEI scale was analyzed by means of an MMRM adjusting by pre-defined factors (gender, age class, NEI scale baseline value, treatment, visit, and treatment by visit interaction; subject was considered as a random effect).||-0.031|-3.005|0.045
72556165|NCT05133180|144643463|SUPERIORITY||least square mean difference|-1.773||||0.038|TWO_SIDED|95.0|-3.446|-0.101||P-value of LS means difference between treatments from the MMRM on change from baseline in Cornea and conjunctiva vital staining with fluorescein NEI scale at Week 8.|MMRM|||Herein Week 8 was considered. The change from baseline in Cornea and conjunctiva vital staining with fluorescein NEI scale was analyzed by means of an MMRM adjusting by pre-defined factors (gender, age class, NEI scale baseline value, treatment, visit, and treatment by visit interaction; subject was considered as a random effect).||-0.101|-3.446|0.038
72376682|NCT01903252|144262238|OTHER||Percentage|26.3|||||TWO_SIDED|95.0|20.9|32.3||||||||32.3|20.9|
72376683|NCT01903252|144262239|OTHER||Percentage|44.9|||||TWO_SIDED|95.0|38.5|51.3||||||||51.3|38.5|
72376684|NCT01903252|144262240|OTHER||Percentage|0.0|||||TWO_SIDED|95.0|0.0|1.5||||||||1.5|0.0|
72376685|NCT03467685|144262251|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|||||||< 0.05
72376686|NCT01227824|144262262|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority could be concluded if the lower bound of a two-sided 95% confidence interval for the difference (DTG - RAL) in percentages between the two treatment arms was \> -10%.|Difference in percentage|2.5|||||TWO_SIDED|95.0|-2.2|7.1|||||Analysis was based on Cochran-Mantel Haenszel stratified analysis adjusted for the following Baseline stratification factors: baseline HIV-1 RNA and background dual NRTI.|||7.1|-2.2|
72376687|NCT03836001|144262274|SUPERIORITY|||||||0.59||||||A p-value of \<0.05 would be considered statistically significant.|Fisher Exact|||||||0.59
72376688|NCT03836001|144262275|SUPERIORITY|||||||1||||||A p-value of \<0.05 would be considered statistically significant.|Fisher Exact|||||||1
72376689|NCT03836001|144262276|SUPERIORITY|||||||1||||||A p-value of \<0.05 would be considered statistically significant.|Fisher Exact|||||||1
72376690|NCT03836001|144262277|SUPERIORITY|||||||0.67||||||A p-value of \<0.05 would be considered statistically significant.|Fisher Exact|||||||0.67
72376691|NCT03836001|144262278|SUPERIORITY|||||||1||||||A p-value of \<0.05 would be considered statistically significant.|Fisher Exact|||||||1
72376692|NCT03836001|144262279|OTHER||Mean Difference (Net)|-0.11||||0.09|TWO_SIDED|95.0|-0.24|0.02||A p-value of \<0.05 would be considered statistically significant.|Mixed Models Analysis|||Analysis of change from baseline through week 8 including all time points. For this analysis, data were censored at the time of participant discontinuation.||0.02|-0.24|0.09
72376693|NCT03836001|144262280|SUPERIORITY||Mean Difference (Net)|-0.08||||0.16|TWO_SIDED|95.0|-0.19|0.03||A p-value of \<0.05 would be considered statistically significant.|Mixed Models Analysis|||Analysis of change from baseline through week 8 including all time points. For this analysis, data were censored at the time of participant discontinuation.||0.03|-0.19|0.16
72376694|NCT03836001|144262282|OTHER||Mean Difference (Net)|-0.25||||0.002|TWO_SIDED|95.0|-0.41|-0.09||A p-value of \<0.05 would be considered statistically significant.|Mixed Models Analysis|||Analysis of change from baseline through week 8 including all time points. For this analysis, data were censored at the time of participant discontinuation.||-0.09|-0.41|0.002
72376695|NCT03400956|144262375|SUPERIORITY||Risk Difference (RD)|0.82|||<|0.0001|TWO_SIDED|95.0|0.72|0.93|||Cochran-Mantel-Haenszel||Number of subjects per treatment: 63 (Vilaprisan) / 33 (Placebo).|Vilaprisan (A1) and Vilaprisan+Placebo (B2) combined vs. Placebo+Vilaprisan (B1) in treatment period 1||0.93|0.72|<.0001
72376696|NCT02589600|144262386|SUPERIORITY||Incident Rate Ratio|1.05||||0.7251|TWO_SIDED|95.0|0.9|1.22|||Negative binomial regression||Placebo group is the reference group||Negative binomial regression implemented in the SAS®️ GENMOD procedure with fracture outcome as the dependent variable; duration of follow-up as an offset to account for each participant's exposure; treatment arm as the main independent factor of interest.|1.22|.90|0.7251
72376697|NCT01816451|144262401|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||For pre-post training variables data were expressed as mean and standard deviation. Heart Rate and Blood Lactate, were by three-way ANOVA (Measure x Group x Time) with repeated measures for the factors Measure and Time. The variables absolute and relative VO2, tVO2, Body Fat, Body Mass, RPE, were made two-way ANOVAs (Group x Measure) with repeated measures on the factor Measure. Where the ANOVA was significant, the Tukey-Kramer as post-hoc was used.||||< 0.05
72376698|NCT01816451|144262401|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||For pre; during (retest I 0-6weeks; retest II 0-10 weeks) and post training data were expressed as mean and standard deviation. HR and \[La\], were by three-way ANOVA (Measure x Group x Time) with repeated measures for the factors Measure and Time. The variables RPE, Velocity were made two-way ANOVAs (Group x Measure) with repeated measures on the factor Measure. Where the ANOVA was significant, the Tukey-Kramer as post-hoc was used. Control didn't do submaximal test for training intensities.||||<0.05
72376699|NCT00481507|144262443|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.82|||>|0.05|TWO_SIDED|95.0|0.54|1.43||Reply: Only one test was performed for the primary outcome. No covariates were entered into this model and p-value is unadjusted.|Chi-squared|The results obtained from the logistic regression are equivalent to the chi-square test with one degree of freedom.||Reply: The null hypothesis was the rates of diarrhea for Kefir vs. Placebo are not different. Post power calculation was not performed because the difference observed (21.9% vs. 18%) was less than a difference that which would be considered clinically important.||1.43|0.54|>.05
72376700|NCT03445156|144262478|OTHER|ANCOVA||||||0.04|||||||ANCOVA|F(2, 273) = 3.16, p = .044, partial c\^2 = .023||||||0.04
72376701|NCT03445156|144262478|OTHER|ANCOVA||||||0.0001|||||||ANCOVA|F(1, 36) = 44.42||||||.0001
72376702|NCT03445156|144262479|OTHER|ANCOVA|||||<|0.001|||||||ANCOVA|F(1, 36) = 44.42||Hypothesis: Participants who played a violent FPS game were expected to have more hits to targets with heads or faces than were participants who played a nonviolent shooting game.||||<.001
72376703|NCT03445156|144262479|OTHER|ANCOVA||||||0.044|||||||ANCOVA|F(2, 273) = 3.16||Hypothesis: Participants who played a violent FPS game were expected to hit the mannequin's head more often than were participants who played either the nonviolent shooting game or the nonviolent non-shooting game Covariates: participant gender, number of guns owned over their lifetime, attitudes toward guns, and number of times they had fired a gun.||||.044
72376704|NCT03445156|144262479|OTHER|ANCOVA||||||0.17|||||||t-test, 2 sided|t(274) = 2.40||"Hypothesis: Because the nonviolent shooting game rewards other shots, participants who played a nonviolent shooting game were expected to hit the mannequin's torso more often than were participants who played the nonviolent non-shooting game.~Covariates: participant gender, number of guns owned over their lifetime, attitudes toward guns, and number of times they had fired a gun."||||0.17
72376705|NCT03445156|144262479|OTHER|ANCOVA||||||0.449|||||||t-test, 2 sided|t(274) = -0.76||Hypothesis: participants who played a nonviolent shooting game were expected to hit the mannequin's head less often than were participants who played the nonviolent non-shooting game Covariates: participant gender, number of guns owned over their lifetime, attitudes toward guns, and number of times they had fired a gun.||||.449
72376706|NCT03445156|144262479|OTHER|ANCOVA||||||0.645|||||||t-test, 2 sided|t(273) = -0.46||"Hypothesis: participants who played a nonviolent shooting game were expected to hit the mannequin's torso more often than were participants who played the nonviolent non-shooting game.~Covariates: participant gender, number of guns owned over their lifetime, attitudes toward guns, and number of times they had fired a gun."||||.645
72376707|NCT03445156|144262479|OTHER|Zero-order correlation||||||0.032|||||||Zero-order correlation|||Hypothesis: A positive correlation was expected between the number of violent shooting games participants listed among their three favorite video games and hits to the mannequin's head.||||.032
72376708|NCT00545129|144262505|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) Mean Difference|-0.26|STANDARD_ERROR_OF_MEAN|0.45||0.569|TWO_SIDED|95.0|-1.18|0.66|||ANCOVA|||Analysis of covariance (ANCOVA) model included treatment and cancer type as fixed effects, baseline value as covariate and study site as random effect. Least squares (LS) mean difference, and corresponding 95% confidence interval (CI) were estimated from ANCOVA model.||0.66|-1.18|0.569
72395090|NCT00720434|144296641|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-2.36357||||0.0131|TWO_SIDED|95.0|-4.19228|-0.53485|||ANCOVA|||An ANCOVA model was used to compare differences among treatments. Independent variables included treatment and log-transformed baseline HCV viral load. Adjusted mean difference and corresponding 95% CI were calculated.||-0.53485|-4.19228|0.0131
72376709|NCT00545129|144262506|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.23||0.581|TWO_SIDED|95.0|-0.6|0.34|||ANCOVA|||Change at Week 1: ANCOVA model included treatment and cancer type as fixed effects, baseline value as covariate and study site as random effect. LS mean difference and corresponding 95% CI were estimated from ANCOVA model.||0.34|-0.60|0.581
72376710|NCT00545129|144262506|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.08|STANDARD_ERROR_OF_MEAN|0.32||0.795|TWO_SIDED|95.0|-0.56|0.73|||ANCOVA|||Change at Week 2: ANCOVA model included treatment and cancer type as fixed effects, baseline value as covariate and study site as random effect. LS mean difference and corresponding 95% CI were estimated from ANCOVA model.||0.73|-0.56|0.795
72376711|NCT00545129|144262506|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.08|STANDARD_ERROR_OF_MEAN|0.41||0.843|TWO_SIDED|95.0|-0.76|0.93|||ANCOVA|||Change at Week 4: ANCOVA model included treatment and cancer type as fixed effects, baseline value as covariate and study site as random effect. LS mean difference and corresponding 95% CI were estimated from ANCOVA model.||0.93|-0.76|0.843
72376712|NCT00545129|144262506|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.46|STANDARD_ERROR_OF_MEAN|0.43||0.292|TWO_SIDED|95.0|-1.34|0.42|||ANCOVA|||Change at Week 8: ANCOVA model included treatment and cancer type as fixed effects, baseline value as covariate and study site as random effect. LS mean difference and corresponding 95% CI were estimated from ANCOVA model.||0.42|-1.34|0.292
72376713|NCT00545129|144262507|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.24|STANDARD_ERROR_OF_MEAN|0.23||0.299|TWO_SIDED|95.0|-0.72|0.23|||ANCOVA|||Change at Week 1: ANCOVA model included treatment and cancer type as fixed effects, baseline value as covariate and study site as random effect. LS mean difference and corresponding 95% CI were estimated from ANCOVA model.||0.23|-0.72|0.299
72376714|NCT00545129|144262507|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.22|STANDARD_ERROR_OF_MEAN|0.34||0.519|TWO_SIDED|95.0|-0.47|0.91|||ANCOVA|||Change at Week 2: ANCOVA model included treatment and cancer type as fixed effects, baseline value as covariate and study site as random effect. LS mean difference and corresponding 95% CI were estimated from ANCOVA model.||0.91|-0.47|0.519
72376715|NCT00545129|144262507|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.12|STANDARD_ERROR_OF_MEAN|0.42||0.776|TWO_SIDED|95.0|-0.74|0.98|||ANCOVA|||Change at Week 4: ANCOVA model included treatment and cancer type as fixed effects, baseline value as covariate and study site as random effect. LS mean difference and corresponding 95% CI were estimated from ANCOVA model.||0.98|-0.74|0.776
72376716|NCT00545129|144262507|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.45||0.978|TWO_SIDED|95.0|-0.93|0.91|||ANCOVA|||Change at Week 6: ANCOVA model included treatment and cancer type as fixed effects, baseline value as covariate and study site as random effect. LS mean difference and corresponding 95% CI were estimated from ANCOVA model.||0.91|-0.93|0.978
72376717|NCT00545129|144262507|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.45||0.689|TWO_SIDED|95.0|-1.1|0.73|||ANCOVA|||Change at Week 8: ANCOVA model included treatment and cancer type as fixed effects, baseline value as covariate and study site as random effect. LS mean difference and corresponding 95% CI were estimated from ANCOVA model.||0.73|-1.10|0.689
72376718|NCT00545129|144262508|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.24|STANDARD_ERROR_OF_MEAN|0.23||0.299|TWO_SIDED|95.0|-0.72|0.23|||ANCOVA|||Change at Week 1: ANCOVA model included treatment and cancer type as fixed effects, baseline value as covariate and study site as random effect. LS mean difference and corresponding 95% CI were estimated from ANCOVA model.||0.23|-0.72|0.299
72376719|NCT00545129|144262508|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.22|STANDARD_ERROR_OF_MEAN|0.34||0.519|TWO_SIDED|95.0|-0.47|0.91|||ANCOVA|||Change at Week 2: ANCOVA model included treatment and cancer type as fixed effects, baseline value as covariate and study site as random effect. LS mean difference and corresponding 95% CI were estimated from ANCOVA model.||0.91|-0.47|0.519
72376720|NCT00545129|144262508|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.22|STANDARD_ERROR_OF_MEAN|0.44||0.618|TWO_SIDED|95.0|-0.68|1.13|||ANCOVA|||Change at Week 4: ANCOVA model included treatment and cancer type as fixed effects, baseline value as covariate and study site as random effect. LS mean difference and corresponding 95% CI were estimated from ANCOVA model.||1.13|-0.68|0.618
72376721|NCT00545129|144262508|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.11|STANDARD_ERROR_OF_MEAN|0.47||0.818|TWO_SIDED|95.0|-0.85|1.07|||ANCOVA|||Change at Week 6: ANCOVA model included treatment and cancer type as fixed effects, baseline value as covariate and study site as random effect. LS mean difference and corresponding 95% CI were estimated from ANCOVA model.||1.07|-0.85|0.818
72376722|NCT00545129|144262508|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.11|STANDARD_ERROR_OF_MEAN|0.48||0.819|TWO_SIDED|95.0|-0.87|1.09||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 8: ANCOVA model included treatment and cancer type as fixed effects, baseline value as covariate and study site as random effect. LS mean difference and corresponding 95% CI were estimated from ANCOVA model.||1.09|-0.87|0.819
72376723|NCT00545129|144262509|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.04|STANDARD_ERROR_OF_MEAN|0.34||0.906|TWO_SIDED|95.0|-0.66|0.74|||ANCOVA|||Change at Week 1: ANCOVA model included treatment and cancer type as fixed effects, baseline value as covariate and study site as random effect. LS mean difference and corresponding 95% CI were estimated from ANCOVA model.||0.74|-0.66|0.906
72376724|NCT00545129|144262509|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.44||0.906|TWO_SIDED|95.0|-0.95|0.85|||ANCOVA|||Change at Week 2: ANCOVA model included treatment and cancer type as fixed effects, baseline value as covariate and study site as random effect. LS mean difference and corresponding 95% CI were estimated from ANCOVA model.||0.85|-0.95|0.906
72376725|NCT00545129|144262509|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.26|STANDARD_ERROR_OF_MEAN|0.5||0.613|TWO_SIDED|95.0|-0.78|1.29|||ANCOVA|||Change at Week 4: ANCOVA model included treatment and cancer type as fixed effects, baseline value as covariate and study site as random effect. LS mean difference and corresponding 95% CI were estimated from ANCOVA model.||1.29|-0.78|0.613
72433567|NCT00984282|144380303|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Log Rank|stratified by age group and region||||||<0.0001
72433568|NCT00984282|144380303|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.557|||||TWO_SIDED|95.0|0.429|0.724|||Regression, Cox|stratified by age group and region||||0.724|0.429|
72556166|NCT05133180|144643463|SUPERIORITY||least square mean difference|-1.224||||0.2|TWO_SIDED|95.0|-3.096|0.649||P-value of LS means difference between treatments from the MMRM on change from baseline in Cornea and conjunctiva vital staining with fluorescein NEI scale at Week 12|MMRM|||Herein Week 12 was considered. The change from baseline in Cornea and conjunctiva vital staining with fluorescein NEI scale was analyzed by means of an MMRM adjusting by pre-defined factors (gender, age class, NEI scale baseline value, treatment, visit, and treatment by visit interaction; subject was considered as a random effect).||0.649|-3.096|0.200
72376726|NCT00545129|144262509|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.46||0.988|TWO_SIDED|95.0|-0.95|0.94|||ANCOVA|||Change at Week 6: ANCOVA model included treatment and cancer type as fixed effects, baseline value as covariate and study site as random effect. LS mean difference and corresponding 95% CI were estimated from ANCOVA model.||0.94|-0.95|0.988
72376727|NCT00545129|144262509|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.47||0.922|TWO_SIDED|95.0|-1.01|0.92|||ANCOVA|||Change at Week 8: ANCOVA model included treatment and cancer type as fixed effects, baseline value as covariate and study site as random effect. LS mean difference and corresponding 95% CI were estimated from ANCOVA model.||0.92|-1.01|0.922
72376728|NCT00545129|144262510|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.4||0.655|TWO_SIDED|95.0|-1.03|0.66|||ANCOVA|||Change at Week 1: ANCOVA model included treatment and cancer type as fixed effects, baseline value as covariate and study site as random effect. LS mean difference and corresponding 95% CI were estimated from ANCOVA model.||0.66|-1.03|0.655
72376729|NCT00545129|144262510|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.06|STANDARD_ERROR_OF_MEAN|0.44||0.897|TWO_SIDED|95.0|-0.85|0.96|||ANCOVA|||Change at Week 2: ANCOVA model included treatment and cancer type as fixed effects, baseline value as covariate and study site as random effect. LS mean difference and corresponding 95% CI were estimated from ANCOVA model.||0.96|-0.85|0.897
72376730|NCT00545129|144262510|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.13|STANDARD_ERROR_OF_MEAN|0.51||0.798|TWO_SIDED|95.0|-0.93|1.2|||ANCOVA|||Change at Week 4: ANCOVA model included treatment and cancer type as fixed effects, baseline value as covariate and study site as random effect. LS mean difference and corresponding 95% CI were estimated from ANCOVA model.||1.20|-0.93|0.798
72376731|NCT00545129|144262510|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.22|STANDARD_ERROR_OF_MEAN|0.51||0.672|TWO_SIDED|95.0|-0.83|1.27|||ANCOVA|||Change at Week 6: ANCOVA model included treatment and cancer type as fixed effects, baseline value as covariate and study site as random effect. LS mean difference and corresponding 95% CI were estimated from ANCOVA model.||1.27|-0.83|0.672
72556167|NCT05133180|144643464|SUPERIORITY||least square mean difference|1.64||||0.016|TWO_SIDED|95.0|0.3|2.98||P-value of LS means difference between treatments from the MMRM on change from baseline in TFBUT at Week 4.|MMRM|||Herein week 4 was considered. The change from baseline in TFBUT values was analyzed by means of a MMRM adjusting by pre-defined factors (gender, age class, TFBUT baseline value, treatment, visit, and treatment by visit interaction; subject was considered as a random effect).||2.980|0.300|0.016
72556168|NCT05133180|144643464|SUPERIORITY||least ssquare mean difference|1.133||||0.129|TWO_SIDED|95.0|-0.329|2.596||P-value of LS means difference between treatments from the MMRM on change from baseline in TFBUT at Week 8.|MMRM|||Herein week 8 was considered. The change from baseline in TFBUT values was analyzed by means of a MMRM adjusting by pre-defined factors (gender, age class, TFBUT baseline value, treatment, visit, and treatment by visit interaction; subject was considered as a random effect).||2.596|-0.329|0.129
72556169|NCT05133180|144643464|SUPERIORITY||least square mean difference|1.36||||0.05|TWO_SIDED|95.0|-0.002|2.722||P-value of LS means difference between treatments from the MMRM on change from baseline in TFBUT at Week 12.|MMRM|||Herein week 12 was considered. The change from baseline in TFBUT values was analyzed by means of a MMRM adjusting by pre-defined factors (gender, age class, TFBUT baseline value, treatment, visit, and treatment by visit interaction; subject was considered as a random effect).||2.722|-0.002|0.050
72556170|NCT05133180|144643465|SUPERIORITY||||||<|0.001||||||p-value corresponds to a non-parametric Mann-Whitney-Wilcoxon (Wilcoxon rank sum) test of the comparisons between Cenegermin and Vehicle in all participants.|Wilcoxon (Mann-Whitney)|||Herein Week 4 was considered. Change from baseline between the two treatment groups was compared using a two-sample t-test or a Mann-Whitney-Wilcoxon (Wilson rank sum) test if normality assumption not met.||||<0.001
72376732|NCT00545129|144262510|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.57|STANDARD_ERROR_OF_MEAN|0.48||0.243|TWO_SIDED|95.0|-1.56|0.41|||ANCOVA|||Change at Week 8: ANCOVA model included treatment and cancer type as fixed effects, baseline value as covariate and study site as random effect. LS mean difference and corresponding 95% CI were estimated from ANCOVA model.||0.41|-1.56|0.243
72376733|NCT00545129|144262511|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.32|STANDARD_ERROR_OF_MEAN|0.41||0.445|TWO_SIDED|95.0|-1.16|0.52|||ANCOVA|||Change at Week 1: ANCOVA model included treatment and cancer type as fixed effects, baseline value as covariate and study site as random effect. LS mean difference and corresponding 95% CI were estimated from ANCOVA model.||0.52|-1.16|0.445
72376734|NCT00545129|144262511|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.49||0.992|TWO_SIDED|95.0|-1.0|1.0|||ANCOVA|||Change at Week 2: ANCOVA model included treatment and cancer type as fixed effects, baseline value as covariate and study site as random effect. LS mean difference and corresponding 95% CI were estimated from ANCOVA model.||1.00|-1.00|0.992
72376735|NCT00545129|144262511|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.24|STANDARD_ERROR_OF_MEAN|0.53||0.655|TWO_SIDED|95.0|-1.34|0.86|||ANCOVA|||Change at Week 4: ANCOVA model included treatment and cancer type as fixed effects, baseline value as covariate and study site as random effect. LS mean difference and corresponding 95% CI were estimated from ANCOVA model.||0.86|-1.34|0.655
72376736|NCT00545129|144262511|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.58||0.86|TWO_SIDED|95.0|-1.09|1.3|||ANCOVA|||Change at Week 6: ANCOVA model included treatment and cancer type as fixed effects, baseline value as covariate and study site as random effect. LS mean difference and corresponding 95% CI were estimated from ANCOVA model.||1.30|-1.09|0.860
72433569|NCT00984282|144380304|SUPERIORITY_OR_OTHER||Difference of response rates|11.7||||0.0015|TWO_SIDED|95.0|3.9|19.4||stratified by age group and region|Cochran-Mantel-Haenszel||Difference of disease control rates sorafenib minus placebo. Cochran-Mantel-Haenszel confidence interval stratified by age group and region|||19.4|3.9|0.0015
72376737|NCT00545129|144262511|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.31|STANDARD_ERROR_OF_MEAN|0.59||0.595|TWO_SIDED|95.0|-1.52|0.89|||ANCOVA|||Change at Week 8: ANCOVA model included treatment and cancer type as fixed effects, baseline value as covariate and study site as random effect. LS mean difference and corresponding 95% CI were estimated from ANCOVA model.||0.89|-1.52|0.595
72376738|NCT00545129|144262512|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.5||0.179|TWO_SIDED|95.0|-1.76|0.35|||ANCOVA|||Change at Week 1: ANCOVA model included treatment and cancer type as fixed effects, baseline value as covariate and study site as random effect. LS mean difference and corresponding 95% CI were estimated from ANCOVA model.||0.35|-1.76|0.179
72433570|NCT00984282|144380305|SUPERIORITY_OR_OTHER||Difference in response rate|11.8|||<|0.0001|TWO_SIDED|95.0|7.0|16.5||stratified by age group and region|Cochran-Mantel-Haenszel||Difference of response rates sorafenib minus placebo. Cochran-Mantel-Haenszel confidence interval stratified by age group and region|||16.5|7.0|<0.0001
72433571|NCT02359435|144380315|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.016|||<|0.05|TWO_SIDED||||||Chi-squared|||||||<0.05
72433572|NCT01549314|144380316|SUPERIORITY|||||||0.77|||||||t-test, 2 sided|||Change from baseline to 24 months in cortical volumentric bone mineral density was determined and compared between subjects with CF taking ivacaftor and subjects with CF not taking ivacaftor.||||0.77
72433573|NCT01549314|144380316|SUPERIORITY|||||||0.82|||||||t-test, 2 sided|||Change from baseline to 24 months in cortical volumentric bone mineral density was determined and compared between subjects with CF not taking ivacaftor and healthy subjects.||||0.82
72433574|NCT01549314|144380317|SUPERIORITY|||||||0.64|||||||t-test, 2 sided|||Change from baseline to 24 months in DXA PA spine bone mineral density was determined and compared between subjects with CF taking ivacaftor and subjects with CF not taking ivacaftor.||||0.64
72433575|NCT01549314|144380317|SUPERIORITY|||||||0.78|||||||t-test, 2 sided|||Change from baseline to 24 months in DXA PA spine bone mineral density was determined and compared between subjects with CF not taking ivacaftor and healthy subjects.||||0.78
72433576|NCT01549314|144380318|SUPERIORITY|||||||0.86|||||||t-test, 2 sided|||Change from baseline to 24 months in osteocalcin was determined and compared between subjects with CF taking ivacaftor and subjects with CF not taking ivacaftor.||||0.86
72433577|NCT01549314|144380318|SUPERIORITY|||||||0.99|||||||t-test, 2 sided|||Change from baseline to 24 months in osteocalcin was determined and compared between subjects with CF not taking ivacaftor and healthy subjects.||||0.99
72433578|NCT01289119|144380324|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.58|||<|0.001|TWO_SIDED|95.0|-0.78|-0.37|||ANCOVA|ANCOVA model with treatment as a fixed effect, and baseline HbA1c as a covariate.||The analysis was conducted at the 2-sided 5% significance level without a multiplicity adjustment.||-0.37|-0.78|<0.001
72433579|NCT01289119|144380324|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.69|||<|0.001|TWO_SIDED|95.0|-0.87|-0.51||ANCOVA model with treatment as a fixed effect, and baseline HbA1c with baseline metformin dose as covariates.|ANCOVA|||The analysis was conducted at the 2-sided 5% significance level without a multiplicity adjustment.||-0.51|-0.87|<0.001
72556171|NCT05133180|144643465|SUPERIORITY|||||||0.009||||||p-value corresponds to a non-parametric Mann-Whitney-Wilcoxon (Wilcoxon rank sum) test of the comparisons between Cenegermin and Vehicle in all participants|Wilcoxon (Mann-Whitney)|||Herein Week 8 was considered. Change from baseline between the two treatment groups was compared using a two-sample t-test or a Mann-Whitney-Wilcoxon (Wilson rank sum) test if normality assumption not met.||||0.009
72556172|NCT05133180|144643465|SUPERIORITY|||||||0.02||||||p-value corresponds to a non-parametric Mann-Whitney-Wilcoxon (Wilcoxon rank sum) test of the comparisons between Cenegermin and Vehicle in all participants.|Wilcoxon (Mann-Whitney)|||Herein Week 12 was considered. Change from baseline between the two treatment groups was compared using a two-sample t-test or a Mann-Whitney-Wilcoxon (Wilson rank sum) test if normality assumption not met.||||0.020
72376739|NCT00545129|144262512|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.04|STANDARD_ERROR_OF_MEAN|0.51||0.938|TWO_SIDED|95.0|-1.02|1.1|||ANCOVA|||Change at Week 2: ANCOVA model included treatment and cancer type as fixed effects, baseline value as covariate and study site as random effect. LS mean difference and corresponding 95% CI were estimated from ANCOVA model.||1.10|-1.02|0.938
72433580|NCT01289119|144380324|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.52|||<|0.001|TWO_SIDED|95.0|-0.75|-0.28|||ANCOVA|ANCOVA model with treatment as a fixed effect, and baseline HbA1c with baseline metformin therapy status and baseline pioglitazone dose as covariates.||The analysis was conducted at the 2-sided 5% significance level without a multiplicity adjustment.||-0.28|-0.75|<0.001
72433581|NCT00991276|144380365|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-27.1|STANDARD_ERROR_OF_MEAN|4.38|<|0.0001|TWO_SIDED|95.0|-35.78|-18.42||This analysis was step 1 in a step-down procedure (if p-value \< 0.05, then continue to next step) used to control the Type I error rate.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The least squares (LS) means and standard errors (SE) were used to test for a treatment difference and construct 2-sided 95% confidence intervals (CIs). The hypothesis test was 2-sided and conducted at the 5% level of significance.||-18.42|-35.78|<0.0001
72433582|NCT00991276|144380365|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-26.93|STANDARD_ERROR_OF_MEAN|4.35|<|0.0001|TWO_SIDED|95.0|-35.54|-18.32||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||-18.32|-35.54|<0.0001
72433583|NCT00991276|144380365|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|4.32||0.9684|TWO_SIDED|95.0|-8.72|8.38||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||8.38|-8.72|0.9684
72376740|NCT00545129|144262512|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.28|STANDARD_ERROR_OF_MEAN|0.55||0.621|TWO_SIDED|95.0|-1.41|0.86|||ANCOVA|||Change at Week 4: ANCOVA model included treatment and cancer type as fixed effects, baseline value as covariate and study site as random effect. LS mean difference and corresponding 95% CI were estimated from ANCOVA model.||0.86|-1.41|0.621
72376741|NCT00545129|144262512|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.64||0.863|TWO_SIDED|95.0|-1.44|1.21|||ANCOVA|||Change at Week 6: ANCOVA model included treatment and cancer type as fixed effects, baseline value as covariate and study site as random effect. LS mean difference and corresponding 95% CI were estimated from ANCOVA model.||1.21|-1.44|0.863
72376742|NCT00545129|144262512|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.72|STANDARD_ERROR_OF_MEAN|0.59||0.237|TWO_SIDED|95.0|-1.95|0.51|||ANCOVA|||Change at Week 8: ANCOVA model included treatment and cancer type as fixed effects, baseline value as covariate and study site as random effect. LS mean difference and corresponding 95% CI were estimated from ANCOVA model.||0.51|-1.95|0.237
72376743|NCT00545129|144262513|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.75||||1|TWO_SIDED|95.0|0.1|4.94|||Fisher Exact|||Week 1 (\>=30%) reduction: The odds ratio with 95% 2-sided CI for the treatment contrast was given.||4.94|0.10|1.000
72376744|NCT00545129|144262513|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.88||||1|TWO_SIDED|95.0|0.23|3.32|||Fisher Exact|||Week 2 (\>=30%) reduction: The odds ratio with 95% 2-sided CI for the treatment contrast was given.||3.32|0.23|1.000
72376745|NCT00545129|144262513|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.67||||1|TWO_SIDED|95.0|0.05|6.35|||Fisher Exact|||Week 2 (\>=50%) reduction: The odds ratio with 95% 2-sided CI for the treatment contrast was given.||6.35|0.05|1.000
72376746|NCT00545129|144262513|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.4||||0.601|TWO_SIDED|95.0|0.44|4.53|||Fisher Exact|||Week 4 (\>=30%) reduction: The odds ratio with 95% 2-sided CI for the treatment contrast was given.||4.53|0.44|0.601
72376747|NCT00545129|144262513|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.9||||0.36|TWO_SIDED|95.0|0.46|8.51|||Fisher Exact|||Week 4 (\>=50%) reduction: The odds ratio with 95% 2-sided CI for the treatment contrast was given.||8.51|0.46|0.360
72376748|NCT00545129|144262513|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.5||||1|TWO_SIDED|95.0|0.01|10.24|||Fisher Exact|||Week 4 (\>=70%) reduction: The odds ratio with 95% 2-sided CI for the treatment contrast was given.||10.24|0.01|1.000
72376749|NCT00545129|144262513|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.41||||0.596|TWO_SIDED|95.0|0.43|4.66|||Fisher Exact|||Week 6 (\>=30%) reduction: The odds ratio with 95% 2-sided CI for the treatment contrast was given.||4.66|0.43|0.596
72376750|NCT00545129|144262513|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.52||||0.552|TWO_SIDED|95.0|0.39|6.24|||Fisher Exact|||Week 6 (\>=50%) reduction: The odds ratio with 95% 2-sided CI for the treatment contrast was given.||6.24|0.39|0.552
72376751|NCT00545129|144262513|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.15||||0.612|TWO_SIDED|95.0|0.1|131.03|||Fisher Exact|||Week 6 (\>=70%) reduction: The odds ratio with 95% 2-sided CI for the treatment contrast was given.||131.03|0.10|0.612
72376752|NCT00545129|144262513|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.0||||1|TWO_SIDED|95.0|0.0|19.66|||Fisher Exact|||Week 6 (\>=90%) reduction: The odds ratio with 95% 2-sided CI for the treatment contrast was given.||19.66|0.00|1.000
72376753|NCT00545129|144262513|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|3.73||||0.029|TWO_SIDED|95.0|1.04|14.32|||Fisher Exact|||Week 8 (\>=30%) reduction: The odds ratio with 95% 2-sided CI for the treatment contrast was given.||14.32|1.04|0.029
72376754|NCT00545129|144262513|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.63||||0.143|TWO_SIDED|95.0|0.67|11.36|||Fisher Exact|||Week 8 (\>=50%) reduction: The odds ratio with 95% 2-sided CI for the treatment contrast was given.||11.36|0.67|0.143
72376755|NCT00545129|144262513|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.04||||1|TWO_SIDED|95.0|0.07|15.25|||Fisher Exact|||Week 8 (\>=70%) reduction: The odds ratio with 95% 2-sided CI for the treatment contrast was given.||15.25|0.07|1.000
72376756|NCT00545129|144262513|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.0||||0.492|TWO_SIDED|95.0|0.0|3.57|||Fisher Exact|||Week 8 (\>=90%) reduction: The odds ratio with 95% 2-sided CI for the treatment contrast was given.||3.57|0.00|0.492
72376757|NCT00545129|144262514|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.75||||1|TWO_SIDED|95.0|0.1|4.94|||Fisher Exact|||Week 1 (\>=30%) reduction: The odds ratio with 95% 2-sided CI for the treatment contrast was given.||4.94|0.10|1.000
72376758|NCT00545129|144262514|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.88||||1|TWO_SIDED|95.0|0.23|3.32|||Fisher Exact|||Week 2 (\>=30%) reduction: The odds ratio with 95% 2-sided CI for the treatment contrast was given.||3.32|0.23|1.000
72376759|NCT00545129|144262514|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.67||||1|TWO_SIDED|95.0|0.05|6.35|||Fisher Exact|||Week 2 (\>=50%) reduction: The odds ratio with 95% 2-sided CI for the treatment contrast was given.||6.35|0.05|1.000
72376760|NCT00545129|144262514|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.22||||0.795|TWO_SIDED|95.0|0.38|3.88|||Fisher Exact|||Week 4 (\>=30%) reduction: odds ratio with 95% 2-sided CI for the treatment contrast was given.||3.88|0.38|0.795
72376761|NCT00545129|144262514|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.9||||0.36|TWO_SIDED|95.0|0.46|8.51|||Fisher Exact|||Week 4 (\>=50%) reduction: The odds ratio with 95% 2-sided CI for the treatment contrast was given.||8.51|0.46|0.360
72376762|NCT00545129|144262514|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.5||||1|TWO_SIDED|95.0|0.01|10.24|||Fisher Exact|||Week 4 (\>=70%) reduction: The odds ratio with 95% 2-sided CI for the treatment contrast was given.||10.24|0.01|1.000
72376763|NCT00545129|144262514|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.06||||1|TWO_SIDED|95.0|0.33|3.39|||Fisher Exact|||Week 6 (\>=30%) reduction: The odds ratio with 95% 2-sided CI for the treatment contrast was given.||3.39|0.33|1.000
72376764|NCT00545129|144262514|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.25||||0.771|TWO_SIDED|95.0|0.33|4.83|||Fisher Exact|||Week 6 (\>=50%) reduction: The odds ratio with 95% 2-sided CI for the treatment contrast was given.||4.83|0.33|0.771
72376765|NCT00545129|144262514|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.15||||0.612|TWO_SIDED|95.0|0.1|131.03|||Fisher Exact|||Week 6 (\>=70%) reduction: The odds ratio with 95% 2-sided CI for the treatment contrast was given.||131.03|0.10|0.612
72376766|NCT00545129|144262514|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.0||||1|TWO_SIDED|95.0|0.0|19.66|||Fisher Exact|||Week 6 (\>=90%) reduction: The odds ratio with 95% 2-sided CI for the treatment contrast was given.||19.66|0.00|1.000
72376767|NCT00545129|144262514|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.18||||0.187|TWO_SIDED|95.0|0.66|7.3|||Fisher Exact|||Week 8 (\>=30%) reduction: The odds ratio with 95% 2-sided CI for the treatment contrast was given.||7.30|0.66|0.187
72376768|NCT00545129|144262514|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.73||||0.399|TWO_SIDED|95.0|0.48|6.43|||Fisher Exact|||Week 8 (\>=50%) reduction: The odds ratio with 95% 2-sided CI for the treatment contrast was given.||6.43|0.48|0.399
72376769|NCT00545129|144262514|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.04||||1|TWO_SIDED|95.0|0.07|15.25|||Fisher Exact|||Week 8 (\>=70%) reduction: The odds ratio with 95% 2-sided CI for the treatment contrast was given.||15.25|0.07|1.000
72376770|NCT00545129|144262514|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.0||||0.492|TWO_SIDED|95.0|0.0|3.57|||Fisher Exact|||Week 8 (\>=90%) reduction: The odds ratio with 95% 2-sided CI for the treatment contrast was given.||3.57|0.00|0.492
72376771|NCT00545129|144262516|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|1.7|STANDARD_ERROR_OF_MEAN|0.68||0.188|TWO_SIDED|95.0|0.77|3.73|||Negative binomial regression|||Week 1: Negative binomial regression model with model terms for treatment as a main effect. P-value was based on negative binomial regression model from pairwise comparisons. LS mean difference and corresponding 95% CI were estimated from the corresponding negative binomial regression model.||3.73|0.77|0.188
72376772|NCT00545129|144262516|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|1.81|STANDARD_ERROR_OF_MEAN|0.85||0.207|TWO_SIDED|95.0|0.72|4.54|||Negative binomial regression|||Week 2: Negative binomial regression model with model terms for treatment as a main effect. P-value was based on negative binomial regression model from pairwise comparisons. LS mean difference and corresponding 95% CI were estimated from the corresponding negative binomial regression model.||4.54|0.72|0.207
72376773|NCT00545129|144262516|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|1.71|STANDARD_ERROR_OF_MEAN|0.92||0.317|TWO_SIDED|95.0|0.6|4.93|||Negative binomial regression|||Week 3: Negative binomial regression model with model terms for treatment as a main effect. P-value was based on negative binomial regression model from pairwise comparisons. LS mean difference and corresponding 95% CI were estimated from the corresponding negative binomial regression model.||4.93|0.60|0.317
72376774|NCT00545129|144262516|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|1.36|STANDARD_ERROR_OF_MEAN|0.7||0.554|TWO_SIDED|95.0|0.5|3.71|||Negative binomial regression|||Week 4: Negative binomial regression model with model terms for treatment as a main effect. P-value was based on negative binomial regression model from pairwise comparisons. LS mean difference and corresponding 95% CI were estimated from the corresponding negative binomial regression model.||3.71|0.50|0.554
72376775|NCT00545129|144262516|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.78|STANDARD_ERROR_OF_MEAN|0.35||0.581|TWO_SIDED|95.0|0.32|1.89|||Negative binomial regression|||Week 5: Negative binomial regression model with model terms for treatment as a main effect. P-value was based on negative binomial regression model from pairwise comparisons. LS mean difference and corresponding 95% CI were estimated from the corresponding negative binomial regression model.||1.89|0.32|0.581
72376776|NCT00545129|144262516|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.61|STANDARD_ERROR_OF_MEAN|0.27||0.252|TWO_SIDED|95.0|0.26|1.43|||Negative binomial regression|||Week 6: Negative binomial regression model with model terms for treatment as a main effect. P-value was based on negative binomial regression model from pairwise comparisons. LS mean difference and corresponding 95% CI were estimated from the corresponding negative binomial regression model.||1.43|0.26|0.252
72376777|NCT00545129|144262516|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.65|STANDARD_ERROR_OF_MEAN|0.31||0.365|TWO_SIDED|95.0|0.26|1.64|||Negative binomial regression|||Week 7: Negative binomial regression model with model terms for treatment as a main effect. P-value was based on negative binomial regression model from pairwise comparisons. LS mean difference and corresponding 95% CI were estimated from the corresponding negative binomial regression model.||1.64|0.26|0.365
72376778|NCT00545129|144262516|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.58|STANDARD_ERROR_OF_MEAN|0.25||0.212|TWO_SIDED|95.0|0.25|1.36|||Negative binomial regression|||Week 8: Negative binomial regression model with model terms for treatment as a main effect. P-value was based on negative binomial regression model from pairwise comparisons. LS mean difference and corresponding 95% CI were estimated from the corresponding negative binomial regression model.||1.36|0.25|0.212
72376779|NCT00545129|144262517|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.21|STANDARD_ERROR_OF_MEAN|0.17||0.215|TWO_SIDED|95.0|-0.13|0.55|||ANCOVA|||Change at Week 2 (Fatigue MDA): LS mean difference and corresponding 95% CI were estimated from the corresponding repeated measures ANCOVA model.||0.55|-0.13|0.215
72376780|NCT00545129|144262517|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.21||0.947|TWO_SIDED|95.0|-0.45|0.42|||ANCOVA|||Change at Week 4 (Fatigue MDA): LS mean difference and corresponding 95% CI were estimated from the corresponding repeated measures ANCOVA model.||0.42|-0.45|0.947
72376781|NCT00545129|144262517|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.18||0.341|TWO_SIDED|95.0|-0.56|0.2|||ANCOVA|||Change at Week 6 (Fatigue MDA): LS mean difference and corresponding 95% CI were estimated from the corresponding repeated measures ANCOVA model.||0.20|-0.56|0.341
72376782|NCT00545129|144262517|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.33|STANDARD_ERROR_OF_MEAN|0.24||0.18|TWO_SIDED|95.0|-0.83|0.17|||ANCOVA|||Change at Week 2 (Drowsiness MDA): LS mean difference and corresponding 95% CI were estimated from the corresponding repeated measures ANCOVA model.||0.17|-0.83|0.180
72376783|NCT00545129|144262517|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|0.3||0.509|TWO_SIDED|95.0|-0.43|0.84|||ANCOVA|||Change at Week 4 (Drowsiness MDA): LS mean difference and corresponding 95% CI were estimated from the corresponding repeated measures ANCOVA model.||0.84|-0.43|0.509
72376784|NCT00545129|144262517|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.34||0.767|TWO_SIDED|95.0|-0.62|0.82|||ANCOVA|||Change at Week 6 (Drowsiness MDA): LS mean difference and corresponding 95% CI were estimated from the corresponding repeated measures ANCOVA model.||0.82|-0.62|0.767
72376785|NCT00545129|144262517|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.42|STANDARD_ERROR_OF_MEAN|0.25||0.108|TWO_SIDED|95.0|-0.11|0.95|||ANCOVA|||Change at Week 2 (Inability to Concentrate MDA): LS mean difference and corresponding 95% CI were estimated from the corresponding repeated measures ANCOVA model.||0.95|-0.11|0.108
72376786|NCT00545129|144262517|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.43|STANDARD_ERROR_OF_MEAN|0.37||0.28|TWO_SIDED|95.0|-1.26|0.41|||ANCOVA|||Change at Week 4 (Inability to Concentrate MDA): LS mean difference and corresponding 95% CI were estimated from the corresponding repeated measures ANCOVA model.||0.41|-1.26|0.280
72376787|NCT00545129|144262517|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.57||0.747|TWO_SIDED|95.0|-1.53|1.15|||ANCOVA|||Change at Week 6 (Inability to Concentrate MDA): LS mean difference and corresponding 95% CI were estimated from the corresponding repeated measures ANCOVA model.||1.15|-1.53|0.747
72376788|NCT00545129|144262517|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.39||0.991|TWO_SIDED|95.0|-0.87|0.88|||ANCOVA|||Change at Week 2 (Nausea MDA): LS mean difference and corresponding 95% CI were estimated from the corresponding repeated measures ANCOVA model.||0.88|-0.87|0.991
72376789|NCT00545129|144262517|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.29|STANDARD_ERROR_OF_MEAN|0.27||0.335|TWO_SIDED|95.0|-0.41|0.99|||ANCOVA|||Change at Week 4 (Nausea MDA): LS mean difference and corresponding 95% CI were estimated from the corresponding repeated measures ANCOVA model.||0.99|-0.41|0.335
72376790|NCT00545129|144262517|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.55|STANDARD_ERROR_OF_MEAN|0.7||0.159|TWO_SIDED|95.0|-4.57|1.48|||ANCOVA|||Change at Week 6 (Nausea MDA): LS mean difference and corresponding 95% CI were estimated from the corresponding repeated measures ANCOVA model.||1.48|-4.57|0.159
72376791|NCT00545129|144262517|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.39|STANDARD_ERROR_OF_MEAN|0.23||0.136|TWO_SIDED|95.0|-0.16|0.94|||ANCOVA|||Change at Week 2 (Dizziness MDA): LS mean difference and corresponding 95% CI were estimated from the corresponding repeated measures ANCOVA model.||0.94|-0.16|0.136
72376792|NCT00545129|144262517|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|1.22|STANDARD_ERROR_OF_MEAN|0.37||0.186|TWO_SIDED|95.0|-3.46|5.9|||ANCOVA|||Change at Week 6 (Dizziness MDA): LS mean difference and corresponding 95% CI were estimated from the corresponding repeated measures ANCOVA model.||5.90|-3.46|0.186
72376793|NCT00545129|144262517|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.52|STANDARD_ERROR_OF_MEAN|0.48||0.292|TWO_SIDED|95.0|-1.52|0.49|||ANCOVA|||Change at Week 2 (Constipation MDA): LS mean difference and corresponding 95% CI were estimated from the corresponding repeated measures ANCOVA model.||0.49|-1.52|0.292
72376794|NCT00545129|144262517|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.48|STANDARD_ERROR_OF_MEAN|0.38||0.225|TWO_SIDED|95.0|-0.34|1.3|||ANCOVA|||Change at Week 4 (Constipation MDA): LS mean difference and corresponding 95% CI were estimated from the corresponding repeated measures ANCOVA model.||1.30|-0.34|0.225
72376795|NCT00545129|144262517|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.25|STANDARD_ERROR_OF_MEAN|0.36||0.517|TWO_SIDED|95.0|-0.58|1.07|||ANCOVA|||Change at Week 6 (Constipation MDA): LS mean difference and corresponding 95% CI were estimated from the corresponding repeated measures ANCOVA model.||1.07|-0.58|0.517
72556173|NCT05133180|144643465|SUPERIORITY|||||||0.022||||||p-value corresponds to a non-parametric Mann-Whitney-Wilcoxon (Wilcoxon rank sum) test of the comparisons between Cenegermin and Vehicle in all participants.|Wilcoxon (Mann-Whitney)|||Herein Week 16 was considered. Change from baseline between the two treatment groups was compared using a two-sample t-test or a Mann-Whitney-Wilcoxon (Wilson rank sum) test if normality assumption not met.||||0.022
72376796|NCT00545129|144262517|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.58||1|TWO_SIDED|95.0|-2.48|2.48|||ANCOVA|||Change at Week 2 (Itching MDA): LS mean difference and corresponding 95% CI were estimated from the corresponding repeated measures ANCOVA model.||2.48|-2.48|1.000
72376797|NCT00545129|144262517|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.0|<|0.001|TWO_SIDED|95.0|-1.01|-0.99|||ANCOVA|||Change at Week 4 (Itching MDA): LS mean difference and corresponding 95% CI were estimated from the corresponding repeated measures ANCOVA model.||-0.99|-1.01|<0.001
72376798|NCT00545129|144262517|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.44|STANDARD_ERROR_OF_MEAN|0.43||0.362|TWO_SIDED|95.0|-0.75|1.63|||ANCOVA|||Change at Week 2 (Difficulty with Urination MDA): LS mean difference and corresponding 95% CI were estimated from the corresponding repeated measures ANCOVA model.||1.63|-0.75|0.362
72376799|NCT00545129|144262517|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|4.08||1|TWO_SIDED|95.0|-51.87|51.87|||ANCOVA|||Change at Week 4 (Difficulty with Urination MDA): LS mean difference and corresponding 95% CI were estimated from the corresponding repeated measures ANCOVA model.||51.87|-51.87|1.000
72376800|NCT00545129|144262517|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-2.03|STANDARD_ERROR_OF_MEAN|0.1||0.031|TWO_SIDED|95.0|-3.3|-0.76|||ANCOVA|||Change at Week 4 (Retching/Vomiting MDR): LS mean difference and corresponding 95% CI were estimated from the corresponding repeated measures ANCOVA model.||-0.76|-3.30|0.031
72376801|NCT00545129|144262517|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.02|STANDARD_ERROR_OF_MEAN|0.15||0.886|TWO_SIDED|95.0|-0.28|0.32|||ANCOVA|||Change at Week 2 (Frequency Composite Score): LS mean difference and corresponding 95% CI were estimated from the corresponding repeated measures ANCOVA model.||0.32|-0.28|0.886
72376802|NCT00545129|144262517|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.21||0.66|TWO_SIDED|95.0|-0.52|0.33|||ANCOVA|||Change at Week 4 (Frequency Composite Score): LS mean difference and corresponding 95% CI were estimated from the corresponding repeated measures ANCOVA model.||0.33|-0.52|0.660
72376803|NCT00545129|144262517|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.17||0.238|TWO_SIDED|95.0|-0.54|0.14|||ANCOVA|||Change at Week 6 (Frequency Composite Score): LS mean difference and corresponding 95% CI were estimated from the corresponding repeated measures ANCOVA model.||0.14|-0.54|0.238
72376804|NCT00545129|144262517|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.14||0.36|TWO_SIDED|95.0|-0.42|0.16|||ANCOVA|||Change at Week 2 (Severity Composite Score): LS mean difference and corresponding 95% CI were estimated from the corresponding repeated measures ANCOVA model.||0.16|-0.42|0.360
72376805|NCT00545129|144262517|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.19|STANDARD_ERROR_OF_MEAN|0.17||0.278|TWO_SIDED|95.0|-0.16|0.54|||ANCOVA|||Change at Week 4 (Severity Composite Score): LS mean difference and corresponding 95% CI were estimated from the corresponding repeated measures ANCOVA model.||0.54|-0.16|0.278
72376806|NCT00545129|144262517|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.15||0.809|TWO_SIDED|95.0|-0.34|0.27|||ANCOVA|||Change at Week 6 (Severity Composite Score): LS mean difference and corresponding 95% CI were estimated from the corresponding repeated measures ANCOVA model.||0.27|-0.34|0.809
72556174|NCT05133180|144643466|SUPERIORITY|||||||0.065||||||p-value corresponds to a non-parametric Mann-Whitney-Wilcoxon (Wilcoxon rank sum) test of the comparisons between Cenegermin and Vehicle in all participants|Wilcoxon (Mann-Whitney)|||Herein Week 16 was considered. Change from baseline between the two treatment groups was compared using a two-sample t-test or a Mann-Whitney-Wilcoxon (Wilson rank sum) test if normality assumption not met.||||0.065
72556175|NCT05133180|144643467|SUPERIORITY|||||||0.125||||||p-value corresponds to a non-parametric Mann-Whitney-Wilcoxon (Wilcoxon rank sum) test of the comparisons between Cenegermin and Vehicle in all participants.|Wilcoxon (Mann-Whitney)|||Herein week 16 was considered. Change from baseline between the two treatment groups was compared using a two-sample t-test or a Mann-Whitney-Wilcoxon (Wilson rank sum) test if normality assumption not met.||||0.125
72556176|NCT05133180|144643468|SUPERIORITY|||||||0.005||||||p-value corresponds to a non-parametric Mann-Whitney-Wilcoxon (Wilcoxon rank sum) test of the comparisons between Cenegermin and Vehicle in all participants.|Wilcoxon (Mann-Whitney)|||Herein Week 8 was considered. Change from baseline between the two treatment groups was compared using a two-sample t-test or a Mann-Whitney-Wilcoxon (Wilson rank sum) test if normality assumption not met.||||0.005
72556177|NCT05133180|144643468|SUPERIORITY|||||||0.116||||||p-value corresponds to a non-parametric Mann-Whitney-Wilcoxon (Wilcoxon rank sum) test of the comparisons between Cenegermin and Vehicle in all participants.|Wilcoxon (Mann-Whitney)|||Herein Week 12 was considered. Change from baseline between the two treatment groups was compared using a two-sample t-test or a Mann-Whitney-Wilcoxon (Wilson rank sum) test if normality assumption not met.||||0.116
72556178|NCT05133180|144643468|SUPERIORITY|||||||0.864||||||p-value corresponds to a non-parametric Mann-Whitney-Wilcoxon (Wilcoxon rank sum) test of the comparisons between Cenegermin and Vehicle in all participants.|Wilcoxon (Mann-Whitney)|||Herein Week 16 was considered. Change from baseline between the two treatment groups was compared using a two-sample t-test or a Mann-Whitney-Wilcoxon (Wilson rank sum) test if normality assumption not met.||||0.864
72556179|NCT05133180|144643469|SUPERIORITY|||||||0.011||||||p-value corresponds to a non-parametric Mann-Whitney-Wilcoxon (Wilcoxon rank sum) test of the comparisons between Cenegermin and Vehicle in all participants.|Wilcoxon (Mann-Whitney)|||Herein Week 8 was considered. Change from baseline between the two treatment groups was compared using a two-sample t-test or a Mann-Whitney-Wilcoxon (Wilson rank sum) test if normality assumption not met.||||0.011
72556180|NCT05133180|144643469|SUPERIORITY|||||||0.316||||||p-value corresponds to a non-parametric Mann-Whitney-Wilcoxon (Wilcoxon rank sum) test of the comparisons between Cenegermin and Vehicle in all participants.|Wilcoxon (Mann-Whitney)|||Herein Week 12 was considered. Change from baseline between the two treatment groups was compared using a two-sample t-test or a Mann-Whitney-Wilcoxon (Wilson rank sum) test if normality assumption not met.||||0.316
72556181|NCT05133180|144643469|SUPERIORITY|||||||0.685||||||p-value corresponds to a non-parametric Mann-Whitney-Wilcoxon (Wilcoxon rank sum) test of the comparisons between Cenegermin and Vehicle in all participants.|Wilcoxon (Mann-Whitney)|||Herein Week 16 was considered. Change from baseline between the two treatment groups was compared using a two-sample t-test or a Mann-Whitney-Wilcoxon (Wilson rank sum) test if normality assumption not met.||||0.685
72556182|NCT05133180|144643470|SUPERIORITY|||||||0.016||||||p-value corresponds to a non-parametric Mann-Whitney-Wilcoxon (Wilcoxon rank sum) test of the comparisons between Cenegermin and Vehicle in all participants.|Wilcoxon (Mann-Whitney)|||Herein Week 8 was considered. Change from baseline between the two treatment groups was compared using a two-sample t-test or a Mann-Whitney-Wilcoxon (Wilson rank sum) test if normality assumption not met.||||0.016
72556183|NCT05133180|144643470|SUPERIORITY|||||||0.16||||||p-value corresponds to a non-parametric Mann-Whitney-Wilcoxon (Wilcoxon rank sum) test of the comparisons between Cenegermin and Vehicle in all participants|Wilcoxon (Mann-Whitney)|||Herein Week 12 was considered. Change from baseline between the two treatment groups was compared using a two-sample t-test or a Mann-Whitney-Wilcoxon (Wilson rank sum) test if normality assumption not met.||||0.160
72556184|NCT05133180|144643470|SUPERIORITY|||||||0.839||||||p-value corresponds to a non-parametric Mann-Whitney-Wilcoxon (Wilcoxon rank sum) test of the comparisons between Cenegermin and Vehicle in all participants.|Wilcoxon (Mann-Whitney)|||Herein Week 16 was considered. Change from baseline between the two treatment groups was compared using a two-sample t-test or a Mann-Whitney-Wilcoxon (Wilson rank sum) test if normality assumption not met.||||0.839
72556185|NCT05133180|144643471|SUPERIORITY|||||||0.0455|||||||Chi-squared|||||||0.0455
72556186|NCT05133180|144643472|SUPERIORITY|Changes from baseline in each IDEEL modules scale score was analyzed by comparing the two treatment groups using a two-sample t-test or a Mann-Whitney-Wilcoxon (Wilson rank sum) test if normality assumption was not met.||||||0.06||||||p-value corresponds to two sample (independent group) t-test of the comparisons between Cenegermin and Vehicle in all participants.|t-test, 2 sided|||Quality of life - Impact on daily activities - Week 8||||0.060
72376807|NCT00545129|144262517|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.18||0.944|TWO_SIDED|95.0|-0.35|0.38|||ANCOVA|||Change at Week 2 (Bother Composite Score): LS mean difference and corresponding 95% CI were estimated from the corresponding repeated measures ANCOVA model.||0.38|-0.35|0.944
72376808|NCT00545129|144262517|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.03|STANDARD_ERROR_OF_MEAN|0.26||0.892|TWO_SIDED|95.0|-0.48|0.55|||ANCOVA|||Change at Week 4 (Bother Composite Score): LS mean difference and corresponding 95% CI were estimated from the corresponding repeated measures ANCOVA model.||0.55|-0.48|0.892
72556187|NCT05133180|144643472|SUPERIORITY|Changes from baseline in each IDEEL modules scale score was analyzed by comparing the two treatment groups using a two-sample t-test or a Mann-Whitney-Wilcoxon (Wilson rank sum) test if normality assumption was not met.||||||0.079||||||p-value corresponds to two sample (independent group) t-test of the comparisons between Cenegermin and Vehicle in all participants.|t-test, 2 sided|||Quality of life - Emotional impact due to Dry eye - Week 8||||0.079
72556188|NCT05133180|144643472|SUPERIORITY|Changes from baseline in each IDEEL modules scale score was analyzed by comparing the two treatment groups using a two-sample t-test or a Mann-Whitney-Wilcoxon (Wilson rank sum) test if normality assumption was not met.||||||0.251||||||p-value corresponds to two sample (independent group) t-test of the comparisons between Cenegermin and Vehicle in all participants|t-test, 2 sided|||Quality of life - Impact on work due to Dry Eye - Week 8||||0.251
72376809|NCT00545129|144262517|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.03|STANDARD_ERROR_OF_MEAN|0.21||0.884|TWO_SIDED|95.0|-0.39|0.45|||ANCOVA|||Change at Week 6 (Bother Composite Score): LS mean difference and corresponding 95% CI were estimated from the corresponding repeated measures ANCOVA model.||0.45|-0.39|0.884
72376810|NCT00545129|144262517|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.13||0.919|TWO_SIDED|95.0|-0.26|0.28|||ANCOVA|||Change at Week 2 (MDA Composite Score): LS mean difference and corresponding 95% CI were estimated from the corresponding repeated measures ANCOVA model.||0.28|-0.26|0.919
72376811|NCT00545129|144262517|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.06|STANDARD_ERROR_OF_MEAN|0.19||0.752|TWO_SIDED|95.0|-0.33|0.45|||ANCOVA|||Change at Week 4 (MDA Composite Score): LS mean difference and corresponding 95% CI were estimated from the corresponding repeated measures ANCOVA model.||0.45|-0.33|0.752
72376812|NCT00545129|144262517|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.14||0.715|TWO_SIDED|95.0|-0.34|0.24|||ANCOVA|||Change at Week 6 (MDA Composite Score): LS mean difference and corresponding 95% CI were estimated from the corresponding repeated measures ANCOVA model.||0.24|-0.34|0.715
72376813|NCT00545129|144262518|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.21|STANDARD_ERROR_OF_MEAN|0.47||0.666|TWO_SIDED|95.0|-0.77|1.18|||ANCOVA|||Change at Week 1 (Composite Score): ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.||1.18|-0.77|0.666
72376814|NCT00545129|144262518|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.16|STANDARD_ERROR_OF_MEAN|0.49||0.745|TWO_SIDED|95.0|-0.86|1.18|||ANCOVA|||Change at Week 2 (Composite Score): ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.||1.18|-0.86|0.745
72376815|NCT00545129|144262518|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.48||0.749|TWO_SIDED|95.0|-1.14|0.83|||ANCOVA|||Change at Week 4 (Composite Score): ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.||0.83|-1.14|0.749
72376816|NCT00545129|144262518|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.5||0.794|TWO_SIDED|95.0|-1.16|0.9|||ANCOVA|||Change at Week 6 (Composite Score): ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.||0.90|-1.16|0.794
72376817|NCT00545129|144262518|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.56||0.772|TWO_SIDED|95.0|-1.33|1.0|||ANCOVA|||Change at Week 8 (Composite Score): ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.||1.00|-1.33|0.772
72556189|NCT05133180|144643472|SUPERIORITY|Changes from baseline in each IDEEL modules scale score was analyzed by comparing the two treatment groups using a two-sample t-test or a Mann-Whitney-Wilcoxon (Wilson rank sum) test if normality assumption was not met.||||||0.203||||||p-value corresponds to two sample (independent group) t-test of the comparisons between Cenegermin and Vehicle in all participants.|t-test, 2 sided|||Quality of life - Impact on daily activities - Week 16||||0.203
72376818|NCT00545129|144262518|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.31|STANDARD_ERROR_OF_MEAN|0.5||0.547|TWO_SIDED|95.0|-0.73|1.34|||ANCOVA|||Change at Week 1 (General Activity): ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.||1.34|-0.73|0.547
72376819|NCT00545129|144262518|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.26|STANDARD_ERROR_OF_MEAN|0.57||0.65|TWO_SIDED|95.0|-1.43|0.91|||ANCOVA|||Change at Week 2 (General Activity): ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.||0.91|-1.43|0.650
72376820|NCT00545129|144262518|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.55||0.808|TWO_SIDED|95.0|-1.27|1.0|||ANCOVA|||Change at Week 4 (General Activity): ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.||1.00|-1.27|0.808
72376821|NCT00545129|144262518|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.55||0.915|TWO_SIDED|95.0|-1.19|1.07|||ANCOVA|||Change at Week 6 (General Activity): ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.||1.07|-1.19|0.915
72376822|NCT00545129|144262518|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.65||0.757|TWO_SIDED|95.0|-1.54|1.14|||ANCOVA|||Change at Week 8 (General Activity): ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.||1.14|-1.54|0.757
72376823|NCT00545129|144262518|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.57||0.987|TWO_SIDED|95.0|-1.19|1.17|||ANCOVA|||Change at Week 1 (Walking Ability): ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.||1.17|-1.19|0.987
72376824|NCT00545129|144262518|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.18|STANDARD_ERROR_OF_MEAN|0.64||0.781|TWO_SIDED|95.0|-1.14|1.51|||ANCOVA|||Change at Week 2 (Walking Ability): ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.||1.51|-1.14|0.781
72376825|NCT00545129|144262518|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.13|STANDARD_ERROR_OF_MEAN|0.61||0.834|TWO_SIDED|95.0|-1.13|1.38|||ANCOVA|||Change at Week 4 (Walking Ability): ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.||1.38|-1.13|0.834
72376826|NCT00545129|144262518|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.59||0.851|TWO_SIDED|95.0|-1.32|1.1|||ANCOVA|||Change at Week 6 (Walking Ability): ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.||1.10|-1.32|0.851
72376827|NCT00545129|144262518|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.27|STANDARD_ERROR_OF_MEAN|0.68||0.701|TWO_SIDED|95.0|-1.68|1.15|||ANCOVA|||Change at Week 8 (Walking Ability): ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.||1.15|-1.68|0.701
72376828|NCT00545129|144262518|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.45|STANDARD_ERROR_OF_MEAN|0.59||0.453|TWO_SIDED|95.0|-1.68|0.77|||ANCOVA|||Change at Week 1 (Normal Work): ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.||0.77|-1.68|0.453
72376829|NCT00545129|144262518|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.77|STANDARD_ERROR_OF_MEAN|0.67||0.258|TWO_SIDED|95.0|-2.15|0.6|||ANCOVA|||Change at Week 2 (Normal Work): ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.||0.60|-2.15|0.258
72376830|NCT00545129|144262518|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.64||0.736|TWO_SIDED|95.0|-1.53|1.09|||ANCOVA|||Change at Week 4 (Normal Work): ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.||1.09|-1.53|0.736
72376831|NCT00545129|144262518|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.45|STANDARD_ERROR_OF_MEAN|0.64||0.491|TWO_SIDED|95.0|-1.76|0.87|||ANCOVA|||Change at Week 6 (Normal Work): ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.||0.87|-1.76|0.491
72376832|NCT00545129|144262518|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.25|STANDARD_ERROR_OF_MEAN|0.62||0.695|TWO_SIDED|95.0|-1.53|1.04|||ANCOVA|||Change at Week 8 (Normal Work): ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.||1.04|-1.53|0.695
72376833|NCT00545129|144262519|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.6||0.897|TWO_SIDED|95.0|-1.34|1.19|||ANCOVA|||Change at Week 1 (Composite Score): ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.||1.19|-1.34|0.897
72556190|NCT05133180|144643472|SUPERIORITY|Changes from baseline in each IDEEL modules scale score was analyzed by comparing the two treatment groups using a two-sample t-test or a Mann-Whitney-Wilcoxon (Wilson rank sum) test if normality assumption was not met.||||||0.114||||||p-value corresponds to two sample (independent group) t-test of the comparisons between Cenegermin and Vehicle in all participants.|t-test, 2 sided|||Quality of life - Emotional impact due to Dry eye - Week 16||||0.114
72376834|NCT00545129|144262519|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.26|STANDARD_ERROR_OF_MEAN|0.56||0.643|TWO_SIDED|95.0|-0.9|1.43|||ANCOVA|||Change at Week 2 (Composite Score): ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.||1.43|-0.90|0.643
72376835|NCT00545129|144262519|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.38|STANDARD_ERROR_OF_MEAN|0.51||0.464|TWO_SIDED|95.0|-1.45|0.68|||ANCOVA|||Change at Week 4 (Composite Score): ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.||0.68|-1.45|0.464
72376836|NCT00545129|144262519|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.56||0.593|TWO_SIDED|95.0|-1.46|0.86|||ANCOVA|||Change at Week 6 (Composite Score): ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.||0.86|-1.46|0.593
72376837|NCT00545129|144262519|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.61||0.423|TWO_SIDED|95.0|-1.77|0.77|||ANCOVA|||Change at Week 8 (Composite Score): ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.||0.77|-1.77|0.423
72376838|NCT00545129|144262519|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.16|STANDARD_ERROR_OF_MEAN|0.65||0.805|TWO_SIDED|95.0|-1.21|1.54|||ANCOVA|||Change at Week 1 (General Activity): ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.||1.54|-1.21|0.805
72376839|NCT00545129|144262519|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.68||0.882|TWO_SIDED|95.0|-1.3|1.51|||ANCOVA|||Change at Week 2 (General Activity): ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.||1.51|-1.30|0.882
72376840|NCT00545129|144262519|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.49|STANDARD_ERROR_OF_MEAN|0.63||0.446|TWO_SIDED|95.0|-1.79|0.81|||ANCOVA|||Change at Week 4 (General Activity): ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.||0.81|-1.79|0.446
72376841|NCT00545129|144262519|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.36|STANDARD_ERROR_OF_MEAN|0.68||0.604|TWO_SIDED|95.0|-1.77|1.05|||ANCOVA|||Change at Week 6 (General Activity): ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.||1.05|-1.77|0.604
72376842|NCT00545129|144262519|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.66|STANDARD_ERROR_OF_MEAN|0.76||0.393|TWO_SIDED|95.0|-2.24|0.91|||ANCOVA|||Change at Week 8 (General Activity): ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.||0.91|-2.24|0.393
72376843|NCT00545129|144262519|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.68|STANDARD_ERROR_OF_MEAN|0.79||0.399|TWO_SIDED|95.0|-2.33|0.97|||ANCOVA|||Change at Week 1 (Walking Ability): ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.||0.97|-2.33|0.399
72376844|NCT00545129|144262519|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.12|STANDARD_ERROR_OF_MEAN|0.75||0.876|TWO_SIDED|95.0|-1.43|1.66|||ANCOVA|||Change at Week 2 (Walking Ability): ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.||1.66|-1.43|0.876
72376845|NCT00545129|144262519|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.66||0.74|TWO_SIDED|95.0|-1.58|1.14|||ANCOVA|||Change at Week 4 (Walking Ability): ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.||1.14|-1.58|0.740
72376846|NCT00545129|144262519|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.69||0.854|TWO_SIDED|95.0|-1.56|1.31|||ANCOVA|||Change at Week 6 (Walking Ability): ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.||1.31|-1.56|0.854
72395091|NCT00720434|144296641|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-2.4919||||0.0142|TWO_SIDED|95.0|-4.44619|-0.5376|||ANCOVA|||An ANCOVA model was used to compare differences among treatments. Independent variables included treatment and log-transformed baseline HCV viral load. Adjusted mean difference and corresponding 95% CI were calculated.||-0.53760|-4.44619|0.0142
72395092|NCT00720434|144296641|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.46325||||0.1368|TWO_SIDED|95.0|-3.41898|0.49248|||ANCOVA|||An ANCOVA model was used to compare differences among treatments. Independent variables included treatment and log-transformed baseline HCV viral load. Adjusted mean difference and corresponding 95% CI were calculated.||0.49248|-3.41898|0.1368
72395093|NCT00720434|144296641|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.90032||||0.3321|TWO_SIDED|95.0|-2.76711|0.96648|||ANCOVA|||An ANCOVA model was used to compare differences among treatments. Independent variables included treatment and log-transformed baseline HCV viral load. Adjusted mean difference and corresponding 95% CI were calculated.||0.96648|-2.76711|0.3321
72395094|NCT00720434|144296641|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.02865||||0.2839|TWO_SIDED|95.0|-2.95573|0.89844|||ANCOVA|||An ANCOVA model was used to compare differences among treatments. Independent variables included treatment and log-transformed baseline HCV viral load. Adjusted mean difference and corresponding 95% CI were calculated.||0.89844|-2.95573|0.2839
72395095|NCT00720434|144296641|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.12833||||0.8891|TWO_SIDED|95.0|-1.73676|1.99342|||ANCOVA|||An ANCOVA model was used to compare differences among treatments. Independent variables included treatment and log-transformed baseline HCV viral load. Adjusted mean difference and corresponding 95% CI were calculated.||1.99342|-1.73676|0.8891
72395096|NCT01577329|144296642|SUPERIORITY_OR_OTHER|||||||0.05||||||This is a calculated P value and was not adjusted for multiple comparisons.|ANOVA|||This is a calculated P value comparing two groups at baseline and follow-up||||0.05
72395097|NCT02557698|144296654|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.9||||0.002|TWO_SIDED|95.0|-3.1|-0.8|||t-test, 2 sided|||H0=Intervention and control groups do not differ with respect to the TEWL forearm at visit 3 H1=The TEWL on the forearm at visit 3 differs between the groups||-0.8|-3.1|0.002
72395098|NCT02557698|144296655|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.3|||<|0.001|TWO_SIDED|95.0|-3.5|-1.2|||t-test, 2 sided|||||-1.2|-3.5|<0.001
72395099|NCT02557698|144296656|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.7||||0.024|TWO_SIDED|95.0|-3.2|-0.2|||t-test, 2 sided|||||-0.2|-3.2|0.024
72395100|NCT02557698|144296657|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.7||||0.017|TWO_SIDED|95.0|-3.1|-0.3|||t-test, 2 sided|||||-0.3|-3.1|0.017
72395101|NCT02557698|144296658|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.964|TWO_SIDED|95.0|-3.9|3.7|||t-test, 2 sided|||||3.7|-3.9|0.964
72395102|NCT02557698|144296659|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.4||||0.025|TWO_SIDED|95.0|0.5|8.2|||t-test, 2 sided|||||8.2|0.5|0.025
72395103|NCT02557698|144296660|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7||||0.458|TWO_SIDED|95.0|-2.5|1.1|||t-test, 2 sided|||||1.1|-2.5|0.458
72395104|NCT02557698|144296661|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.7||||0.066|TWO_SIDED|95.0|-3.5|0.1|||t-test, 2 sided|||||0.1|-3.5|0.066
72395105|NCT02557698|144296662|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.6||||0.171|TWO_SIDED|95.0|-13.7|2.5|||t-test, 2 sided|||||2.5|-13.7|0.171
72395106|NCT02557698|144296663|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.5||||0.059|TWO_SIDED|95.0|-15.3|0.3|||t-test, 2 sided|||||0.3|-15.3|0.059
72395107|NCT02557698|144296664|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2||||0.4|TWO_SIDED|95.0|-0.2|0.5|||t-test, 2 sided|||||0.5|-0.2|0.400
72395108|NCT02557698|144296665|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||0.1|TWO_SIDED|95.0|-0.1|0.4|||t-test, 2 sided|||||0.4|-0.1|0.100
72395109|NCT02557698|144296666|SUPERIORITY_OR_OTHER|||||||1|||||||Wilcoxon (Mann-Whitney)|||||||1.000
72395110|NCT02557698|144296667|SUPERIORITY_OR_OTHER|||||||0.914|||||||Wilcoxon (Mann-Whitney)|||||||0.914
72395111|NCT02557698|144296668|SUPERIORITY_OR_OTHER|||||||0.822|||||||Wilcoxon (Mann-Whitney)|||||||0.822
72395112|NCT02557698|144296669|SUPERIORITY_OR_OTHER|||||||0.585|||||||Wilcoxon (Mann-Whitney)|||||||0.585
72395113|NCT02557698|144296670|SUPERIORITY_OR_OTHER|||||||0.259|||||||Wilcoxon (Mann-Whitney)|||||||0.259
72395114|NCT02557698|144296671|SUPERIORITY_OR_OTHER|||||||0.581|||||||Wilcoxon (Mann-Whitney)|||||||0.581
72395115|NCT02557698|144296672|SUPERIORITY_OR_OTHER|||||||0.182|||||||Wilcoxon (Mann-Whitney)|||||||0.182
72395116|NCT02557698|144296673|SUPERIORITY_OR_OTHER|||||||0.759|||||||Wilcoxon (Mann-Whitney)|||||||0.759
72376847|NCT00545129|144262519|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.62|STANDARD_ERROR_OF_MEAN|0.78||0.436|TWO_SIDED|95.0|-2.24|1.0|||ANCOVA|||Change at Week 8 (Walking Ability): ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.||1.00|-2.24|0.436
72376848|NCT00545129|144262519|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.3|STANDARD_ERROR_OF_MEAN|0.72||0.087|TWO_SIDED|95.0|-2.81|0.21|||ANCOVA|||Change at Week 1 (Normal Work): ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.||0.21|-2.81|0.087
72376849|NCT00545129|144262519|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.84|STANDARD_ERROR_OF_MEAN|0.75||0.278|TWO_SIDED|95.0|-2.4|0.72|||ANCOVA|||Change at Week 2 (Normal Work): ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.||0.72|-2.40|0.278
72376850|NCT00545129|144262519|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.42|STANDARD_ERROR_OF_MEAN|0.69||0.548|TWO_SIDED|95.0|-1.84|1.0|||ANCOVA|||Change at Week 4 (Normal Work): ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.||1.00|-1.84|0.548
72376851|NCT00545129|144262519|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.77|STANDARD_ERROR_OF_MEAN|0.75||0.318|TWO_SIDED|95.0|-2.33|0.79|||ANCOVA|||Change at Week 6 (Normal Work): ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.||0.79|-2.33|0.318
72376852|NCT00545129|144262519|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.52|STANDARD_ERROR_OF_MEAN|0.73||0.484|TWO_SIDED|95.0|-2.02|0.99|||ANCOVA|||Change at Week 8 (Normal Work): ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.||0.99|-2.02|0.484
72376853|NCT00545129|144262520|SUPERIORITY_OR_OTHER_LEGACY|||||||0.399|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 1: P-value was calculated by Cochran-Mantel-Haenszel (CMH test) stratified by center.||||0.399
72376854|NCT00545129|144262520|SUPERIORITY_OR_OTHER_LEGACY|||||||0.779|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 2: P-value was calculated by CMH test stratified by center.||||0.779
72433584|NCT00991276|144380366|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-3.68|STANDARD_ERROR_OF_MEAN|0.89|<|0.0001|TWO_SIDED|95.0|-5.44|-1.92||This analysis was step 2 in a step-down procedure (if p-value \< 0.05, then continue to next step) used to control the Type I error rate.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||-1.92|-5.44|<0.0001
72376855|NCT00545129|144262520|SUPERIORITY_OR_OTHER_LEGACY|||||||0.922|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 4: P-value was calculated by CMH test stratified by center.||||0.922
72376856|NCT00545129|144262520|SUPERIORITY_OR_OTHER_LEGACY|||||||0.811|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 6: P-value was calculated by CMH test stratified by center.||||0.811
72376857|NCT00545129|144262520|SUPERIORITY_OR_OTHER_LEGACY|||||||0.237|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 8: P-value was calculated by CMH test stratified by center.||||0.237
72376858|NCT00545129|144262521|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.37|STANDARD_ERROR_OF_MEAN|0.22||0.108|TWO_SIDED|95.0|-0.82|0.09|||ANCOVA|||Change at Week 1: ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean and corresponding 95% CI were estimated from the corresponding ANCOVA model.||0.09|-0.82|0.108
72376859|NCT00545129|144262521|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.27|STANDARD_ERROR_OF_MEAN|0.21||0.202|TWO_SIDED|95.0|-0.7|0.16|||ANCOVA|||Change at Week 2: ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean and corresponding 95% CI were estimated from the corresponding ANCOVA model.||0.16|-0.70|0.202
72376860|NCT00545129|144262521|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.2||0.571|TWO_SIDED|95.0|-0.54|0.3|||ANCOVA|||Change at Week 4: ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean and corresponding 95% CI were estimated from the corresponding ANCOVA model.||0.30|-0.54|0.571
72376861|NCT00545129|144262521|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.24||0.808|TWO_SIDED|95.0|-0.55|0.43|||ANCOVA|||Change at Week 6: ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean and corresponding 95% CI were estimated from the corresponding ANCOVA model.||0.43|-0.55|0.808
72376862|NCT00545129|144262521|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.26||0.913|TWO_SIDED|95.0|-0.57|0.51|||ANCOVA|||Change at Week 8: ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean and corresponding 95% CI were estimated from the corresponding ANCOVA model.||0.51|-0.57|0.913
72376863|NCT00545129|144262522|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.37|STANDARD_ERROR_OF_MEAN|0.22||0.108|TWO_SIDED|95.0|-0.82|0.09|||ANCOVA|||Change at Week 1: ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.||0.09|-0.82|0.108
72618404|NCT01292473|144767759|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-1.68||||0.1207|TWO_SIDED|95.0|-3.82|0.45||Refer to the Type-I error control plan. The p-value was not evaluated for statistical significance in accordance with the Type I error control plan provided in the Detailed Description.|ANCOVA|Covariates included in the analysis were baseline overall DLQI score (\< median vs ≥ median) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis is that there is no difference between the placebo and omalizumab 75 mg groups.||0.45|-3.82|0.1207
72376864|NCT00545129|144262522|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.21|STANDARD_ERROR_OF_MEAN|0.21||0.339|TWO_SIDED|95.0|-0.65|0.23|||ANCOVA|||Change at Week 2: ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.||0.23|-0.65|0.339
72376865|NCT00545129|144262522|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.23||0.408|TWO_SIDED|95.0|-0.67|0.28|||ANCOVA|||Change at Week 4: ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.||0.28|-0.67|0.408
72376866|NCT00545129|144262522|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.27||0.686|TWO_SIDED|95.0|-0.67|0.45|||ANCOVA|||Change at Week 6: ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.||0.45|-0.67|0.686
72376867|NCT00545129|144262522|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.21|STANDARD_ERROR_OF_MEAN|0.3||0.493|TWO_SIDED|95.0|-0.81|0.4|||ANCOVA|||Change at Week 8: ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.||0.40|-0.81|0.493
72376868|NCT00545129|144262523|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.58||||0.724|TWO_SIDED|95.0|0.03|12.27|||Fisher Exact|||Week 1: The odds ratio with 95% 2-sided CI for the treatment contrast was given.||12.27|0.03|0.724
72376869|NCT00545129|144262523|SUPERIORITY_OR_OTHER_LEGACY|||||||0.947|TWO_SIDED||||||Fisher Exact|||Week 2: P-value was calculated using Fisher Extract method.||||0.947
72376870|NCT00545129|144262523|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.5||||0.634|TWO_SIDED|95.0|0.03|8.71|||Fisher Exact|||Week 4: The odds ratio with 95% 2-sided CI for the treatment contrast was given.||8.71|0.03|0.634
72376871|NCT00545129|144262523|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.03||||0.975|TWO_SIDED|95.0|0.14|7.74|||Fisher Exact|||Week 6: The odds ratio with 95% 2-sided CI for the treatment contrast was given.||7.74|0.14|0.975
72376872|NCT00545129|144262523|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.49||||0.759|TWO_SIDED|95.0|0.12|18.86|||Fisher Exact|||Week 8: The odds ratio with 95% 2-sided CI for the treatment contrast was given.||18.86|0.12|0.759
72376873|NCT00545129|144262524|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.58||||0.724|TWO_SIDED|95.0|0.03|12.27|||Fisher Exact|||Week 1: The odds ratio with 95% 2-sided CI for the treatment contrast was given.||12.27|0.03|0.724
72376874|NCT00545129|144262524|SUPERIORITY_OR_OTHER_LEGACY|||||||0.95|TWO_SIDED||||||Fisher Exact|||Week 2: P-value was calculated using Fisher Extract test.||||0.950
72376875|NCT00545129|144262524|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.5||||0.634|TWO_SIDED|95.0|0.03|8.71|||Fisher Exact|||Week 4: The odds ratio with 95% 2-sided CI for the treatment contrast was given.||8.71|0.03|0.634
72376876|NCT00545129|144262524|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.03||||0.975|TWO_SIDED|95.0|0.14|7.74|||Fisher Exact|||Week 6: The odds ratio with 95% 2-sided CI for the treatment contrast was given.||7.74|0.14|0.975
72376877|NCT00545129|144262524|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.02||||0.578|TWO_SIDED|95.0|0.17|23.89|||Fisher Exact|||Week 8: The odds ratio with 95% 2-sided CI for the treatment contrast was given.||23.89|0.17|0.578
72376878|NCT02057042|144262554|SUPERIORITY||||||<|0.05|||||||Mixed Models Analysis|||||||<0.05
72376879|NCT02057042|144262555|SUPERIORITY||||||<|0.05|||||||Mixed Models Analysis|||||||<0.05
72376880|NCT02057042|144262556|SUPERIORITY||||||<|0.05|||||||Mixed Models Analysis|||||||<0.05
72376881|NCT02057042|144262557|SUPERIORITY||||||<|0.05|||||||Mixed Models Analysis|||||||<0.05
72376882|NCT02057042|144262558|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
72376883|NCT02057042|144262559|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
72376884|NCT02882152|144262568|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||"Results were compared by means of the ANOVA of repeated measures followed by Bonferroni test.~Comparing: all four moments, from zero to 72hs within femoral blockade group, all four moments within morphine group, and all four moments between the groups"||||<0.05
72376885|NCT02882152|144262569|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||"Results were compared by means of the ANOVA of repeated measures followed by Bonferroni test.~Comparing: all four moments, from zero to 72hs within femoral blockade group, all four moments within morphine group, and all four moments between the groups"||||<0.05
72618405|NCT01292473|144767759|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-2.51||||0.0215|TWO_SIDED|95.0|-4.64|-0.38||Refer to the Type-I error control plan.|ANCOVA|Covariates included in the analysis were baseline overall DLQI score (\< median vs ≥ median) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis is that there is no difference between the placebo and omalizumab 150 mg groups.||-0.38|-4.64|0.0215
72376886|NCT01475071|144262594|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non inferiority margin of -10%|Mean Difference (Final Values)|-3.5|STANDARD_DEVIATION|15.6||0.0345|ONE_SIDED|95.0|-6.8||||paired Student's t statistic|||The primary purpose of this study is to demonstrate the non-inferiority of Metvix and daylight compared to Metvix and the lamp in terms of lesion complete response rate.|||-6.8|0.0345
72376887|NCT01475071|144262595|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.9|STANDARD_DEVIATION|2.7|<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|two-sided Wilcoxon rank signed||superiority of Metvix adaylight and Metvix Lamp in term of pain||||<0.001
72376888|NCT01437995|144262622|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.07|||||TWO_SIDED|95.3|0.69|1.65||||||||1.65|0.69|
72376889|NCT01437995|144262623|SUPERIORITY_OR_OTHER|||||||0.43|||||||Kruskal-Wallis|||||||0.43
72376890|NCT01437995|144262623|SUPERIORITY_OR_OTHER|||||||0.022|||||||Kruskal-Wallis|||||||0.022
72376891|NCT01437995|144262623|SUPERIORITY_OR_OTHER|||||||0.002|||||||Kruskal-Wallis|||||||0.002
72376892|NCT01437995|144262624|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.93|||||TWO_SIDED|95.0|0.63|1.41||||||||1.41|0.63|
72376893|NCT01437995|144262624|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.18|||||TWO_SIDED|95.0|0.8|1.73||||||||1.73|0.80|
72376894|NCT01437995|144262624|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.24|||||TWO_SIDED|95.0|0.83|1.81||||||||1.81|0.83|
72376895|NCT01437995|144262625|SUPERIORITY_OR_OTHER|||||||0.15|||||||Kruskal-Wallis|||Comparing change in pre-bronchodilator FEV1||||0.15
72376896|NCT01437995|144262625|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Kruskal-Wallis|||Comparing change in pre-bronchodilator FEV1||||<0.001
72376897|NCT01437995|144262625|SUPERIORITY_OR_OTHER|||||||0.027|||||||Kruskal-Wallis|||Comparing change in pre-bronchodilator FEV1||||0.027
72376898|NCT01437995|144262625|SUPERIORITY_OR_OTHER|||||||0.4|||||||Kruskal-Wallis|||Comparison of change in pre-bronchodilator FVC||||0.40
72376899|NCT01437995|144262625|SUPERIORITY_OR_OTHER|||||||0.032|||||||Kruskal-Wallis|||Comparison of change in pre-bronchodilator FVC||||0.032
72376900|NCT01437995|144262625|SUPERIORITY_OR_OTHER|||||||0.21|||||||Kruskal-Wallis|||Comparison of change in pre-bronchodilator FVC||||0.21
72376901|NCT01437995|144262626|SUPERIORITY_OR_OTHER|||||||0.14|||||||Kruskal-Wallis|||Comparison of change in FEV1/FVC ratio||||0.14
72376902|NCT01437995|144262626|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Kruskal-Wallis|||Comparison of change in FEV1/FVC ratio||||<0.001
72376903|NCT01437995|144262626|SUPERIORITY_OR_OTHER|||||||0.031|||||||Kruskal-Wallis|||Comparison of change in FEV1/FVC ratio||||0.031
72376904|NCT04456673|144262632|SUPERIORITY|A hierarchical testing procedure was used to control type I error and handle primary and first 4 secondary endpoints (reported sequentially) analyses at a 2-sided significance level of 0.05.|Risk Difference (RD)|-0.435||||0.0002|TWO_SIDED|95.0|-0.682|-0.188|||Negative binomial model||Derived using delta method|Derived using negative binomial model with the total number of the events occurring during the 52-week treatment period as the response variable, and treatment group, region (pooled country), ICS dose, smoking status at screening, baseline disease severity, and number of moderate or severe COPD exacerbation events within one year prior to the study as covariates, and log-transformed treatment duration as an offset variable.||-0.188|-0.682|0.0002
72376905|NCT04456673|144262633|SUPERIORITY|A hierarchical testing procedure was used to control type I error and handle primary and first 4 secondary endpoints (reported sequentially) analyses at a 2-sided significance level of 0.05.|Least Square (LS) Mean Difference|0.082||||0.0001|TWO_SIDED|95.0|0.04|0.124|||MMRM model|||Derived from mixed-effect model with repeated measures (MMRM) model with the change from baseline in pre-bronchodilator FEV1 up to Week 12 as response variables, and treatment group, age, sex, height, region (pooled country), ICS dose, smoking status at screening, visit, treatment-by-visit interaction, baseline pre-bronchodilator FEV1, and FEV1 baseline-by-visit interaction as covariates.||0.124|0.040|0.0001
72376906|NCT04456673|144262634|SUPERIORITY|A hierarchical testing procedure was used to control type I error and handle primary and first 4 secondary endpoints (reported sequentially) analyses at a 2-sided significance level of 0.05.|LS Mean Difference|-3.371||||0.0068|TWO_SIDED|95.0|-5.811|-0.931|||MMRM model|||Derived from MMRM model with the change from baseline in SGRQ total score up to Week 52 as response variables, and treatment group, region (pooled country), ICS dose, smoking status at screening, treatment-by-visit interaction, baseline SGRQ total score, and SGRQ baseline-by-visit interaction as covariates.||-0.931|-5.811|0.0068
72376907|NCT04456673|144262635|SUPERIORITY|A hierarchical testing procedure was used to control type I error and handle primary and first 4 secondary endpoints (reported sequentially) analyses at a 2-sided significance level of 0.05.|Odds Ratio (OR)|1.164||||0.3329|TWO_SIDED|95.0|0.856|1.581|||Regression, Logistic|||Derived from logistic regression model which includes treatment group, region (pooled country), ICS dose, smoking status at screening, and baseline SGRQ total score as covariates.||1.581|0.856|0.3329
72376908|NCT04456673|144262636|SUPERIORITY|A hierarchical testing procedure was used to control type I error and handle primary and first 4 secondary endpoints (reported sequentially) analyses at a 2-sided significance level of 0.05.|LS Mean Difference|0.062||||0.0182|TWO_SIDED|95.0|0.011|0.113|||MMRM model|||Derived from MMRM model with the change from baseline in pre-bronchodilator FEV1 up to Week 52 as response variables, and treatment group, age, sex, height, region (pooled country), ICS dose, smoking status at screening, visit, treatment-by-visit interaction, baseline pre-bronchodilator FEV1, and FEV1 baseline-by-visit interaction as covariates.||0.113|0.011|0.0182
72376909|NCT03874429|144262652|NON_INFERIORITY|Non- inferiority was demonstrated if the upper bound of the 95% CI was no higher than 2 points for the the difference of T2259 minus Vismed Multi.|Mean Difference (Net)|0.31|STANDARD_ERROR_OF_MEAN|0.37|||TWO_SIDED|95.0|-0.42|1.05|||ANCOVA|||To assess the non inferiority of T2259 compared to Vismed Multi, two-sided 95% confidence interval from ANCOVA model was computed of the difference of T2259 minus Vismed Multi. The model was adjusted for the main effects of investigation product and baseline score.||1.05|-0.42|
72376910|NCT05028361|144262662|NON_INFERIORITY|One-sided non-inferiority test with the alpha level set at 0.025 and non-inferiority margin of 10%, stratified by site.|Difference in proportions|-5.6||||0.0007|TWO_SIDED|95.0|-15.2|4.0||The upper limit of the 95% CI of the difference was 4% with a noninferiority margin of 10%.|Cochran-Mantel-Haenszel|The upper bound of a site-stratified Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting was used.||The null hypothesis is the Simultaneous group is inferior (i.e., Simultaneous group will have a higher proportion) to the Sequential group in regards to the proportion of participants with at least one moderate or severe fever, chills, myalgia, or arthralgia event after visits 1 and 2 using 10% non-inferiority margin.||4.0|-15.2|0.0007
72376911|NCT05028361|144262663|SUPERIORITY|||||||0.3851|||||||Mantel Haenszel|||||||0.3851
72493925|NCT02653768|144516714|OTHER|As noted above, a statistical test was not specified at this time point. Rather, the data for all time points were included in the model and are presented here descriptively.|Mean Difference (Final Values)|-1.4|||||TWO_SIDED|95.0|-5.2|2.3||||||This is the analysis of between-group difference in change from baseline to 6-month follow-up. We have not included a p-value because there was no pre-specified hypothesis for this time point. Rather, these are additional data obtained from the overall model, for which the 9-month time point was primary and included a pre-specified hypothesis.||2.3|-5.2|
72376912|NCT05028361|144262664|SUPERIORITY|||||||0.2886|||||||Mantel Haenszel|||||||0.2886
72376913|NCT05028361|144262666|OTHER||Comparison of Frequencies|-0.01|||||TWO_SIDED|95.0|-1.66|1.64||The comparison in number of participants with reported SAEs regardless of relationship to study product were made using a difference in proportions along with a 95% confidence interval of the difference.||||||1.64|-1.66|
72376914|NCT02047318|144262670|EQUIVALENCE|The null hypothesis that the mean change was equal to zero was tested using the Student's t-test to determine if the mean change in sBA levels between MRX baseline and Week 48 was statistically significant.|Mean Difference (Net)|-94.4|STANDARD_DEVIATION|98.915||0.0012|TWO_SIDED|95.0|-145.26|-43.55||Data for this analysis were obtained from 19 participants at MRX baseline; 17 of those participants contributed Week 48 data.|Student's t-test|||This analysis investigated whether a statistically significant change in sBA levels was observed when comparing MRX baseline to Week 48. The analysis was based on the safety population.||-43.55|-145.26|0.0012
72376915|NCT02047318|144262671|EQUIVALENCE|The null hypothesis that the mean change was equal to zero was tested using the Student's t-test to determine if the mean change in sBA levels from baseline over time (to Week 252) was statistically significant.|Mean Difference (Net)|-141.94|STANDARD_DEVIATION|117.992||0.032|TWO_SIDED|95.0|-265.77|-18.12||Data for this analysis were obtained from 19 participants at MRX baseline; 6 of those participants contributed Week 252 data.|Student's t-test|||This analysis investigated whether a statistically significant change in sBA levels was observed over time (with Week 252 chosen as the end point, as the last analysis visit with at least 6 participants). The analysis was based on the safety population.||-18.12|-265.77|0.032
72376916|NCT02047318|144262672|EQUIVALENCE|The null hypothesis that the mean change was equal to zero was tested using the Student's t-test to determine if the mean change in sBA levels between MRX baseline and Week 48 was statistically significant.|Mean Difference (Net)|-1.095|STANDARD_DEVIATION|0.7173|<|0.0001|TWO_SIDED|95.0|-1.464|-0.726||Data for this analysis were obtained from 19 participants at MRX baseline; 17 of those participants contributed Week 48 data.|Student's t-test|||This analysis investigated whether a statistically significant change in ItchRO(Obs) scores was observed when comparing MRX baseline to Week 48. The analysis was based on the safety population.||-0.726|-1.464|< 0.0001
72376917|NCT02047318|144262673|EQUIVALENCE|The null hypothesis that the mean change was equal to zero was tested using the Student's t-test to determine if the mean change in ItchRO(Obs) scores from baseline over time (to Week 158) was statistically significant.|Mean Difference (Net)|-0.958|STANDARD_DEVIATION|0.7868||0.0307|TWO_SIDED|95.0|-1.784|-0.132||Data for this analysis were obtained from 19 participants at MRX baseline; 6 of those participants contributed Week 158 data.|Student's t-test|||This analysis investigated whether a statistically significant change in ItchRO(Obs) scores was observed over time (with Week 158 chosen as the end point, as the last analysis visit with at least 6 participants). The analysis was based on the safety population.||-0.132|-1.784|0.0307
72376918|NCT02047318|144262676|EQUIVALENCE|The null hypothesis that the mean change was equal to zero was tested using the Student's t-test to determine if the mean change in ALP levels between MRX baseline and Week 48 was statistically significant.|Mean Difference (Net)|7.4|STANDARD_DEVIATION|210.32||0.8863|TWO_SIDED|95.0|-100.7|115.6||Data for this analysis were obtained from 19 participants at MRX baseline; 17 of those participants contributed Week 48 data.|Student's t-test|||This analysis investigated whether a statistically significant change in ALP levels was observed when comparing MRX baseline to Week 48. The analysis was based on the safety population.||115.6|-100.7|0.8863
72376919|NCT02047318|144262677|EQUIVALENCE|The null hypothesis that the mean change was equal to zero was tested using the Student's t-test to determine if the mean change in ALP levels from baseline over time (to Week 252) was statistically significant.|Mean Difference (Net)|-184.3|STANDARD_DEVIATION|322.22||0.22|TWO_SIDED|95.0|-522.5|153.8||Data for this analysis were obtained from 19 participants at MRX baseline; 6 of those participants contributed Week 252 data.|Student's t-test|||This analysis investigated whether a statistically significant change in ALP levels was observed over time (with Week 252 chosen as the end point as the last analysis visit with at least 6 participants). The analysis was based on the safety population.||153.8|-522.5|0.22
72376920|NCT02047318|144262678|EQUIVALENCE|The null hypothesis that the mean change was equal to zero was tested using the Student's t-test to determine if the mean change in ALT levels between MRX baseline and Week 48 was statistically significant.|Mean Difference (Net)|51.6|STANDARD_DEVIATION|89.77||0.0307|TWO_SIDED|95.0|5.4|97.7||Data for this analysis were obtained from 19 participants at MRX baseline; 17 of those participants contributed Week 48 data.|Student's t-test|||This analysis investigated whether a statistically significant change in ALT levels was observed when comparing MRX baseline to Week 48. The analysis was based on the safety population.||97.7|5.4|0.0307
72376921|NCT02047318|144262679|EQUIVALENCE|The null hypothesis that the mean change was equal to zero was tested using the Student's t-test to determine if the mean change in ALT levels from baseline over time (to Week 252) was statistically significant.|Mean Difference (Net)|42.3|STANDARD_DEVIATION|140.41||0.4934|TWO_SIDED|95.0|-105.0|189.7||Data for this analysis were obtained from 19 participants at MRX baseline; 6 of those participants contributed Week 252 data.|Student's t-test|||This analysis investigated whether a statistically significant change in ALT levels was observed over time (with Week 252 chosen as the end point, as the last analysis visit with at least 6 participants). The analysis was based on the safety population.||189.7|-105|0.4934
72556191|NCT05133180|144643472|SUPERIORITY|Changes from baseline in each IDEEL modules scale score was analyzed by comparing the two treatment groups using a two-sample t-test or a Mann-Whitney-Wilcoxon (Wilson rank sum) test if normality assumption was not met.||||||0.112||||||p-value corresponds to two sample (independent group) t-test of the comparisons between Cenegermin and Vehicle in all participants.|t-test, 2 sided|||Quality of life - Impact on work due to Dry Eye - Week 16||||0.112
72556192|NCT05133180|144643473|SUPERIORITY|Changes from baseline in each IDEEL modules scale score was analyzed by comparing the two treatment groups using a two-sample t-test or a Mann-Whitney-Wilcoxon (Wilson rank sum) test if normality assumption was not met.||||||0.002||||||p-value corresponds to two sample (independent group) t-test of the comparisons between Cenegermin and Vehicle in all participants|t-test, 2 sided|||Symptom bother module - Week 8||||0.002
72395117|NCT02557698|144296674|SUPERIORITY_OR_OTHER|||||||0.831|||||||Wilcoxon (Mann-Whitney)|||||||0.831
72395118|NCT02557698|144296675|SUPERIORITY_OR_OTHER|||||||0.084|||||||Wilcoxon (Mann-Whitney)|||||||0.084
72395119|NCT02557698|144296676|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.6||||0.07|TWO_SIDED|95.0|-0.3|7.4|||t-test, 2 sided|||||7.4|-0.3|0.07
72395120|NCT02557698|144296677|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.1||||0.029|TWO_SIDED|95.0|0.4|7.7|||t-test, 2 sided|||||7.7|0.4|0.029
72376922|NCT02047318|144262680|EQUIVALENCE|The null hypothesis that the mean change was equal to zero was tested using the Student's t-test to determine if the mean change in AST levels between MRX baseline and Week 48 was statistically significant|Mean Difference (Net)|21.2|STANDARD_DEVIATION|58.98||0.1571|TWO_SIDED|95.0|-9.1|51.6||Data for this analysis were obtained from 19 participants at MRX baseline; 17 of those participants contributed Week 48 data.|Student's t-test|||This analysis investigated whether a statistically significant change in AST levels was observed when comparing MRX baseline to Week 48. The analysis was based on the safety population.||51.6|-9.1|0.1571
72376923|NCT02047318|144262681|EQUIVALENCE|The null hypothesis that the mean change was equal to zero was tested using the Student's t-test to determine if the mean change in AST levels from baseline over time (to Week 252) was statistically significant.|Mean Difference (Net)|12.2|STANDARD_DEVIATION|101.84||0.7815|TWO_SIDED|95.0|-94.7|119.0||Data for this analysis were obtained from 19 participants at MRX baseline; 6 of those participants contributed Week 252 data.|Student's t-test|||This analysis investigated whether a statistically significant change in AST levels was observed over time (with Week 252 chosen as the end point as the last analysis visit with at least 6 participants). The analysis was based on the safety population.||119|-94.7|0.7815
72376924|NCT02047318|144262682|EQUIVALENCE|The null hypothesis that the mean change was equal to zero was tested using the Student's t-test to determine if the mean change in GGT levels between MRX baseline and Week 48 was statistically significant.|Mean Difference (Net)|-3.9|STANDARD_DEVIATION|257.78||0.9513|TWO_SIDED|95.0|-136.4|128.7||Data for this analysis were obtained from 19 participants at MRX baseline; 17 of those participants contributed Week 48 data.|Student's t-test|||This analysis investigated whether a statistically significant change in GGT levels was observed when comparing MRX baseline to Week 48. The analysis was based on the safety population.||128.7|-136.4|0.9513
72376925|NCT02047318|144262683|EQUIVALENCE|The null hypothesis that the mean change was equal to zero was tested using the Student's t-test to determine if the mean change in GGT levels from baseline over time (to Week 252) was statistically significant.|Mean Difference (Net)|-56.7|STANDARD_DEVIATION|356.88||0.7133|TWO_SIDED|95.0|-431.2|317.9||Data for this analysis were obtained from 19 participants at MRX baseline; 6 of those participants contributed Week 252 data.|Student's t-test|||This analysis investigated whether a statistically significant change in GGT levels was observed over time (with Week 252 chosen as the end point as the last analysis visit with at least 6 participants). The analysis was based on the safety population.||317.9|-431.2|0.7133
72376926|NCT02047318|144262684|EQUIVALENCE|The null hypothesis that the mean change was equal to zero was tested using the Student's t-test to determine if the mean change in total bilirubin levels between MRX baseline and Week 48 was statistically significant.|Mean Difference (Net)|0.16|STANDARD_DEVIATION|2.348||0.7839|TWO_SIDED|95.0|-1.05|1.37||Data for this analysis were obtained from 19 participants at MRX baseline; 17 of those participants contributed Week 48 data.|Student's t-test|||This analysis investigated whether a statistically significant change in total bilirubin levels was observed when comparing MRX baseline to Week 48. The analysis was based on the safety population.||1.37|-1.05|0.7839
72376927|NCT02047318|144262684|EQUIVALENCE|The null hypothesis that the mean change was equal to zero was tested using the Student's t-test to determine if the mean change in direct bilirubin levels between MRX baseline and Week 48 was statistically significant.|Mean Difference (Net)|-0.15|STANDARD_DEVIATION|0.982||0.5298|TWO_SIDED|95.0|-0.66|0.35||Data for this analysis were obtained from 19 participants at MRX baseline; 17 of those participants contributed Week 48 data.|Student's t-test|||This analysis investigated whether a statistically significant change in direct bilirubin levels was observed when comparing MRX baseline to Week 48. The analysis was based on the safety population.||0.35|-0.66|0.5298
72376928|NCT02047318|144262685|EQUIVALENCE|The null hypothesis that the mean change was equal to zero was tested using the Student's t-test to determine if the mean change in total bilirubin levels from baseline over time (to Week 252) was statistically significant.|Mean Difference (Net)|-0.53|STANDARD_DEVIATION|5.505||0.8218|TWO_SIDED|95.0|-6.31|5.24||Data for this analysis were obtained from 19 participants at MRX baseline; 6 of those participants contributed Week 252 data.|Student's t-test|||This analysis investigated whether a statistically significant change in total bilirubin levels was observed over time (with Week 252 chosen as the end point as the last analysis visit with at least 6 participants). The analysis was based on the safety population.||5.24|-6.31|0.8218
72376929|NCT02047318|144262685|EQUIVALENCE|The null hypothesis that the mean change was equal to zero was tested using the Student's t-test to determine if the mean change in direct bilirubin levels from baseline over time (to Week 252) was statistically significant.|Mean Difference (Net)|-0.52|STANDARD_DEVIATION|2.001||0.5549|TWO_SIDED|95.0|-2.62|1.58||Data for this analysis were obtained from 19 participants at MRX baseline; 6 of those participants contributed Week 252 data.|Student's t-test|||This analysis investigated whether a statistically significant change in direct bilirubin levels was observed over time (with Week 252 chosen as the end point as the last analysis visit with at least 6 participants). The analysis was based on the safety population.||1.58|-2.62|0.5549
72376930|NCT02296138|144262686|SUPERIORITY|This hypothesis testing strategy ensures that the overall type I error is protected at 2-sided 0.01 level.|Ratio of rates vs. Tiotropium 5 μg|0.93||||0.0498|TWO_SIDED|99.0|0.85|1.02|||Negative binomial model||Ratio of events Tiotropium (5 μg) + Olodaterol (5 μg) versus Tiotropium (5 μg) is provided.|Annualised rate of moderate to severe COPD exacerbation was analysed using a negative binomial model including the fixed, categorical effect of treatment as well as the logarithm of the treatment exposure as an offset.||1.02|0.85|0.0498
72395121|NCT02557698|144296678|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6||||0.325|TWO_SIDED|95.0|-1.8|0.6|||t-test, 2 sided|||||0.6|-1.8|0.325
72395122|NCT02557698|144296679|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9||||0.365|TWO_SIDED|95.0|-2.6|0.9|||t-test, 2 sided|||||0.9|-2.6|0.365
72395123|NCT02557698|144296680|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.6||||0.143|TWO_SIDED|95.0|-8.5|1.3|||t-test, 2 sided|||||1.3|-8.5|0.143
72395124|NCT02557698|144296681|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.1||||0.662|TWO_SIDED|95.0|-6.5|4.2|||t-test, 2 sided|||||4.2|-6.5|0.662
72395125|NCT02557698|144296682|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.326|TWO_SIDED|95.0|-0.4|0.1|||t-test, 2 sided|||||0.1|-0.4|0.326
72395126|NCT02557698|144296683|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.687|TWO_SIDED|95.0|-0.2|0.4|||t-test, 2 sided|||||0.4|-0.2|0.687
72376931|NCT02296138|144262686|SUPERIORITY||Ratio of rates|0.89||||0.001|TWO_SIDED|95.0|0.84|0.96|||Negative binomial model||Ratio of rates Tiotropium (5 μg) versus Tiotropium (5 μg) + Olodaterol (5 μg) is provided.|Model was based on SPARK/FLAME- Covariates: Smoking status, baseline inhaled corticosteroid, Global Initiative on Chronic Obstructive Lung Disease stage, region, COPD Assessment Test score (replacing baseline symptom score), exacerbations treated with antibiotics/steroids history in previous year (replacing 1-year history of exacerbations)||0.96|0.84|0.0010
72376932|NCT02296138|144262686|SUPERIORITY||Ratio of rates|0.91||||0.008|TWO_SIDED|95.0|0.85|0.98|||Negative binomial model||Ratio of rates Tiotropium (5 μg) versus Tiotropium (5 μg) + Olodaterol (5 μg) is provided.|Model was based on HERMES- Covariates: age, sex, smoking status, baseline Long-acting Beta-agonist/inhaled corticosteroid, region and percent predicted post-bronchodilator Forced Expiratory Volume in One Second||0.98|0.85|0.0080
72376933|NCT02296138|144262686|SUPERIORITY||Ratio of rates|0.89||||0.0011|TWO_SIDED|95.0|0.84|0.96|||Negative binomial model||Ratio of rates Tiotropium (5 μg) versus Tiotropium (5 μg) + Olodaterol (5 μg) is provided.|Model was based on TRINITY/TRILOGY- Covariates: Treatment, region, severity of airflow limitation, and smoking status as effects, and exacerbations treated with antibiotics/steroids in previous year.||0.96|0.84|0.0011
72376934|NCT02296138|144262687|SUPERIORITY|This hypothesis testing strategy ensures that the overall type I error is protected at 2-sided 0.01 level.|Hazard Ratio (HR)|0.95||||0.1188|TWO_SIDED|99.0|0.87|1.03|||Log Rank||Tiotropium (5 μg) + Olodaterol (5 μg) versus Tiotropium (5 μg)|A Cox's proportional hazard model was used to estimate the hazard ratio and the corresponding Confidence Interval. A log-rank test was used to obtain the p-value||1.03|0.87|0.1188
72376935|NCT02296138|144262688|SUPERIORITY||Ratio of events vs. Tiotropium 5 μg|0.89||||0.1265|TWO_SIDED|95.0|0.76|1.03|||Negative binomial model||Ratio of events Tiotropium (5 μg) + Olodaterol (5 μg) versus Tiotropium (5 μg) is provided.|Annualised rate of exacerbations leading to hospitalization was analysed using a negative binomial model including the fixed, categorical effect of treatment as well as the logarithm of the treatment exposure as an offset.||1.03|0.76|0.1265
72376936|NCT02296138|144262689|SUPERIORITY||Hazard Ratio (HR)|0.93||||0.2773|TWO_SIDED|95.0|0.82|1.06|||Log Rank||Tiotropium (5 μg) + Olodaterol (5 μg) versus Tiotropium (5 μg)|A Cox's proportional hazard model was used to estimate the hazard ratio and the corresponding Confidence Interval. A log-rank test was used to obtain the p-value||1.06|0.82|0.2773
72376937|NCT02296138|144262690|SUPERIORITY||Hazard Ratio (HR)|1.09||||0.7357|TWO_SIDED|95.0|0.67|1.75|||Log Rank||Tiotropium (5 μg) + Olodaterol (5 μg) versus Tiotropium (5 μg)|A Cox's proportional hazard model was used to estimate the hazard ratio and the corresponding Confidence Interval. A log-rank test was used to obtain the p-value||1.75|0.67|0.7357
72376938|NCT00711516|144262691|SUPERIORITY_OR_OTHER||Median Difference (Net)|-241.8||||0.7382|TWO_SIDED|95.0|-2470.0|2102.3||The hierarchical testing procedure was employed to control the studywise error rate at 0.05.|Wilcoxon (Mann-Whitney)|The assumption of normality was violated (p-value ≤0.05), therefore the treatment comparison was made using a Wilcoxon rank-sum test.||Using the standardized difference of 1.10, 28 evaluable patients (14 per treatment group) were required to provide 80% power while controlling the 2-sided, Type 1 error rate at 0.05. With an estimated 25% attrition rate, a total of 38 patients (19 per group) were planned. First analyzed using ANCOVA,the residuals were used to test for normality using Shapiro-Wilk; normality was violated therefore treatment comparison used the Wilcoxon rank sum.||2102.3|-2470.0|0.7382
72433585|NCT00991276|144380366|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|1.26|STANDARD_ERROR_OF_MEAN|0.88||0.1541|TWO_SIDED|95.0|-0.48|3.01||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||3.01|-0.48|0.1541
72493926|NCT02653768|144516714|SUPERIORITY||Mean Difference (Final Values)|-6.8||||0.0003|TWO_SIDED|95.0|-10.5|-3.2|||Mixed Models Analysis|||This is the analysis of between-group difference in change from baseline to 9-month follow-up. This is the primary outcome assessment time point.||-3.2|-10.5|0.0003
72556193|NCT05133180|144643473|SUPERIORITY|Changes from baseline in each IDEEL modules scale score was analyzed by comparing the two treatment groups using a two-sample t-test or a Mann-Whitney-Wilcoxon (Wilson rank sum) test if normality assumption was not met.||||||0.076||||||p-value corresponds to two sample (independent group) t-test of the comparisons between Cenegermin and Vehicle in all participants|t-test, 2 sided|||Symptom bother module - Week 16||||0.076
72376939|NCT00711516|144262692|SUPERIORITY_OR_OTHER||Median Difference (Net)|53.2||||0.1661|TWO_SIDED|95.0|-17.8|136.1|||Wilcoxon (Mann-Whitney)|||The statistical hypothesis for this key secondary efficacy variable was to be tested using the same model as specified for the primary objective efficacy variable (ANCOVA, ANOVA, and Wilcoxon as appropriate). All statistical tests were 2 tailed at the 0.05 level of significance.||136.1|-17.8|0.1661
72376940|NCT00711516|144262693|SUPERIORITY_OR_OTHER||Median Difference (Net)|78.9||||0.5774|TWO_SIDED|95.0|-157.8|311.3|||Wilcoxon (Mann-Whitney)|||||311.3|-157.8|0.5774
72376941|NCT00711516|144262694|SUPERIORITY_OR_OTHER||Median Difference (Net)|90.1||||0.861|TWO_SIDED|95.0|-806.7|707.0|||Wilcoxon (Mann-Whitney)|||||707.0|-806.7|0.8610
72376942|NCT00711516|144262695|SUPERIORITY_OR_OTHER||Median Difference (Net)|252.8||||0.6907|TWO_SIDED|95.0|-1066.5|1523.8|||Wilcoxon (Mann-Whitney)|||||1523.8|-1066.5|0.6907
72376943|NCT00711516|144262696|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.0||||0.2456|TWO_SIDED|95.0|-8.0|0.0|||Wilcoxon (Mann-Whitney)|||||0.0|-8.0|0.2456
72376944|NCT00711516|144262697|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.0||||0.7115|TWO_SIDED|95.0|-8.0|9.0|||Wilcoxon (Mann-Whitney)|||||9.0|-8.0|0.7115
72376945|NCT00711516|144262698|SUPERIORITY_OR_OTHER||Median Difference (Net)|4.0||||0.6103|TWO_SIDED|95.0|-13.0|19.0|||Wilcoxon (Mann-Whitney)|||||19.0|-13.0|0.6103
72376946|NCT00711516|144262699|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.0||||0.9619|TWO_SIDED|95.0|-18.0|17.0|||Wilcoxon (Mann-Whitney)|||||17.0|-18.0|0.9619
72376947|NCT00711516|144262700|SUPERIORITY_OR_OTHER||Median Difference (Net)|-335.5||||0.4544|TWO_SIDED|95.0|-1270.7|723.3|||Wilcoxon (Mann-Whitney)|||||723.3|-1270.7|0.4544
72556194|NCT05133180|144643474|SUPERIORITY|Changes from baseline in each IDEEL modules scale score was analyzed by comparing the two treatment groups using a two-sample t-test or a Mann-Whitney-Wilcoxon (Wilson rank sum) test if normality assumption was not met.||||||0.16||||||p-value corresponds to two sample (independent group) t-test of the comparisons between Cenegermin and Vehicle in all participants|t-test, 2 sided|||IDEEL - Satisfaction with Treatment Effectiveness - Week 8||||0.160
72556195|NCT05133180|144643474|SUPERIORITY|Changes from baseline in each IDEEL modules scale score was analyzed by comparing the two treatment groups using a two-sample t-test or a Mann-Whitney-Wilcoxon (Wilson rank sum) test if normality assumption was not met.||||||0.009||||||p-value corresponds to two sample (independent group) t-test of the comparisons between Cenegermin and Vehicle in all participants.|t-test, 2 sided|||IDEEL - Treatment- Related Bother / Inconvenience - Week 8||||0.009
72376948|NCT00711516|144262701|SUPERIORITY_OR_OTHER||Median Difference (Net)|6410.3||||0.0193|TWO_SIDED|95.0|1064.7|12087.3|||Wilcoxon (Mann-Whitney)|||||12087.3|1064.7|0.0193
72376949|NCT00711516|144262702|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.0||||0.1704|TWO_SIDED|95.0|-0.1|0.0|||Wilcoxon (Mann-Whitney)|||||0.0|-0.1|0.1704
72376950|NCT00711516|144262703|SUPERIORITY_OR_OTHER||Median Difference (Net)|-0.2||||0.0609|TWO_SIDED|95.0|-0.3|0.0|||Wilcoxon (Mann-Whitney)|||||0.0|-0.3|0.0609
72376951|NCT00711516|144262704|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.9||||0.0499|TWO_SIDED|95.0|-5.8|0.0||Nominal P-value for treatment comparison is from an analysis of covariance (ANCOVA) with treatment and center as factors and the baseline value as covariate.|ANCOVA|||Hierarchical testing procedure was used to control the studywise error rate at 0.05. If treatment was statistically significant on the primary variable, the key secondary variable would be claimed as significant if p-value was \<= 0.05. If primary and key secondary variables were significant subsequent secondary variables following the order presented here would be claimed as significant if their p-values were \<= 0.05. If any were \>0.05 subsequent p-values would be reported as nominal p-values.||-0.0|-5.8|0.0499
72376952|NCT00711516|144262705|SUPERIORITY_OR_OTHER|||||||0.7343||95.0|||||Fisher Exact|||||||0.7343
72376953|NCT00711516|144262706|SUPERIORITY_OR_OTHER||Mean Difference (Net)|6.2||||0.1246|TWO_SIDED|95.0|-1.8|14.3||P-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment and center as factors and the baseline value as a covariate.|ANCOVA|||||14.3|-1.8|0.1246
72376954|NCT00711516|144262707|SUPERIORITY_OR_OTHER||Median Difference (Net)|-4.026||||0.7382|TWO_SIDED|95.0|-21.684|19.98|||Wilcoxon (Mann-Whitney)|||||19.980|-21.684|0.7382
72376955|NCT00711516|144262708|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.086||||1|TWO_SIDED|95.0|-19.195|25.043|||Wilcoxon (Mann-Whitney)|||||25.043|-19.195|1.000
72376956|NCT00711516|144262709|SUPERIORITY_OR_OTHER||Median Difference (Net)|1.282||||0.8861|TWO_SIDED|95.0|-11.46|14.77|||Wilcoxon (Mann-Whitney)|||||14.770|-11.460|0.8861
72376957|NCT00711516|144262710|SUPERIORITY_OR_OTHER||Median Difference (Net)|11.825||||0.4738|TWO_SIDED|95.0|-12.601|37.987|||Wilcoxon (Mann-Whitney)|||||37.987|-12.601|0.4738
72376958|NCT00711516|144262711|SUPERIORITY_OR_OTHER|||||||0.0573||95.0|||||Pearson's Correlation Coefficient|The SAS CORR procedure was used to analyze the activation performance relationships. All estimations are based on Fisher's z-transformation.||Pearson's correlation coefficient was used to assess the relationship between fMRI variable and performance on the 2-back working memory test||||0.0573
72376959|NCT00711516|144262711|SUPERIORITY_OR_OTHER|||||||0.0754||95.0|||||Pearson's Correlation Coefficient|The SAS CORR procedure was used to analyze the activation performance relationships. All estimations are based on Fisher's z-transformation.||||||.0754
72376960|NCT00711516|144262712|SUPERIORITY_OR_OTHER|||||||0.2727||95.0|||||Pearson's Correlation Coefficient|||||||0.2727
72376961|NCT00711516|144262712|SUPERIORITY_OR_OTHER|||||||0.5671||95.0|||||Pearson's Correlation Coefficient|||||||.5671
72376962|NCT00711516|144262713|SUPERIORITY_OR_OTHER|||||||0.1169||95.0|||||Pearson's Correlation Coefficient|The SAS CORR procedure was used to analyze the activation performance relationships. All estimations are based on Fisher's z-transformation.||||||0.1169
72376963|NCT00711516|144262713|SUPERIORITY_OR_OTHER|||||||0.1634||95.0|||||Pearson's Correlation Coefficient|The SAS CORR procedure was used to analyze the activation performance relationships. All estimations are based on Fisher's z-transformation.||||||0.1634
72376964|NCT00711516|144262714|SUPERIORITY_OR_OTHER|||||||0.0692||95.0|||||Pearson's Correlation Coefficient|The SAS CORR procedure was used to analyze the activation performance relationships. All estimations are based on Fisher's Z-transformation.||||||0.0692
72376965|NCT00711516|144262714|SUPERIORITY_OR_OTHER|||||||0.8876||95.0|||||Pearson's Correlation Coefficient|The SAS CORR procedure was used to analyze the activation performance relationships. All estimations are based on Fisher's z-transformation.||||||.8876
72376966|NCT00711516|144262715|SUPERIORITY_OR_OTHER|||||||0.603||95.0|||||Pearson's Correlation Coefficient|The SAS CORR procedure was used to analyze the activation performance relationships. All estimations are based on Fisher's Z-transformation.||||||0.6030
72376967|NCT00711516|144262715|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Pearson's Correlation Coefficient|The SAS CORR procedure was used to analyze the activation performance relationships. All estimations are based on Fisher's z-transformation.||||||<.0001
72376968|NCT00711516|144262716|SUPERIORITY_OR_OTHER|||||||0.917||95.0|||||Pearson's Correlation Coefficient|The SAS CORR procedure was used to analyze the activation performance relationships. All estimations are based on Fisher's Z-transformation.||||||0.9170
72376969|NCT00711516|144262716|SUPERIORITY_OR_OTHER|||||||0.9642||95.0|||||Pearson's Correlation Coefficient|The SAS CORR procedure was used to analyze the activation performance relationships. All estimations are based on Fisher's z-transformation.||||||.9642
72376970|NCT00711516|144262717|SUPERIORITY_OR_OTHER|||||||0.7813||95.0|||||Pearson's Correlation Coefficient|The SAS CORR procedure was used to analyze the activation performance relationships. All estimations are based on Fisher's z-transformation.||||||0.7813
72376971|NCT00711516|144262717|SUPERIORITY_OR_OTHER|||||||0.156||95.0|||||Pearson's Correlation Coefficient|The SAS CORR procedure was used to analyze the activation performance relationships. All estimations are based on Fisher's z-transformation.||||||0.1560
72376972|NCT00711516|144262718|SUPERIORITY_OR_OTHER|||||||0.901||95.0|||||Pearson's Correlation Coefficient|The SAS CORR procedure was used to analyze the activation performance relationships. All estimations are based on Fisher's z-transformation.||||||0.9010
72376973|NCT00711516|144262718|SUPERIORITY_OR_OTHER|||||||0.0135||95.0|||||Pearson's Correlation Coefficient|The SAS CORR procedure was used to analyze the activation performance relationships. All estimations are based on Fisher's z-transformation.||||||0.0135
72376974|NCT00711516|144262727|SUPERIORITY_OR_OTHER||Median Difference (Net)|4.841||||0.7053|TWO_SIDED|95.0|-27.778|19.313|||Wilcoxon (Mann-Whitney)|||||19.313|-27.778|0.7053
72376975|NCT00711516|144262728|SUPERIORITY_OR_OTHER||Median Difference (Net)|4.792||||0.5163|TWO_SIDED|95.0|-30.631|16.19|||Wilcoxon (Mann-Whitney)|||||16.190|-30.631|0.5163
72376976|NCT00711516|144262729|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.108||||0.8711|TWO_SIDED|95.0|-14.341|5.498|||Wilcoxon (Mann-Whitney)|||||5.498|-14.341|0.8711
72376977|NCT00711516|144262730|SUPERIORITY_OR_OTHER||Median Difference (Net)|13.855||||0.1825||95.0|-15.357|25.714|||Wilcoxon (Mann-Whitney)|||||25.714|-15.357|0.1825
72376978|NCT00711516|144262731|SUPERIORITY_OR_OTHER||Median Difference (Net)|-323.5||||0.9282|TWO_SIDED|95.0|-9311.0|2375.5|||Wilcoxon (Mann-Whitney)|||||2375.5|-9311.0|0.9282
72376979|NCT00711516|144262732|SUPERIORITY_OR_OTHER||Median Difference (Net)|1.0||||1|TWO_SIDED|95.0|-1069.0|426.0|||Wilcoxon (Mann-Whitney)|||||426.0|-1069.0|1.0000
72376980|NCT00711516|144262733|SUPERIORITY_OR_OTHER||Median Difference (Net)|-82.8||||0.5284|TWO_SIDED|95.0|-788.0|165.5|||Wilcoxon (Mann-Whitney)|||||165.5|-788.0|0.5284
72376981|NCT00711516|144262734|SUPERIORITY_OR_OTHER||Median Difference (Net)|-145.8||||0.8997|TWO_SIDED|95.0|-3151.0|1006.5|||Wilcoxon (Mann-Whitney)|||||1006.5|-3151.0|0.8997
72376982|NCT00711516|144262735|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-25.1||||0.1305|TWO_SIDED|95.0|-58.2|8.0|||ANCOVA|||||8.0|-58.2|0.1305
72376983|NCT02108262|144262745|NON_INFERIORITY|The calculation used a non-inferiority argument powering the test of the alternative hypothesis of no difference in the rates. Within each co-primary endpoint, the two active treatment groups are assumed to have the same endpoint rates. Total alpha is 0.05 with 0.025 allocated to each co-primary endpoint, which in turn involves comparisons of two active treatment groups to placebo without further alpha control.|Difference in event rates (%)|1.0|||=|0.1241|TWO_SIDED|95.0|-0.1|2.5|||Newcombe-Wilson score method|||||2.5|-0.1|= 0.1241
72376984|NCT02108262|144262745|NON_INFERIORITY|The calculation used a non-inferiority argument powering the test of the alternative hypothesis of no difference in the rates. Within each co-primary endpoint, the two active treatment groups are assumed to have the same endpoint rates. Total alpha is 0.05 with 0.025 allocated to each co-primary endpoint, which in turn involves comparisons of two active treatment groups to placebo without further alpha control.|Difference in event rates (%)|0.5|||=|0.4994|TWO_SIDED|95.0|-0.5|1.7|||Newcombe-Wilson score method|||||1.7|-0.5|= 0.4994
72376985|NCT02108262|144262746|NON_INFERIORITY|The calculation used a non-inferiority argument powering the test of the alternative hypothesis of no difference in the rates. Within each co-primary endpoint, the two active treatment groups are assumed to have the same endpoint rates. Total alpha is 0.05 with 0.025 allocated to each co-primary endpoint, which in turn involves comparisons of two active treatment groups to placebo without further alpha control.|Difference in event rates (%)|-0.2|||=|0.4988|TWO_SIDED|95.0|-1.4|0.7|||Newcombe-Wilson score method|||||0.7|-1.4|= 0.4988
72433586|NCT00991276|144380366|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-4.94|STANDARD_ERROR_OF_MEAN|0.88|<|0.0001|TWO_SIDED|95.0|-6.68|-3.21||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||-3.21|-6.68|<0.0001
72376986|NCT02108262|144262746|NON_INFERIORITY|The calculation used a non-inferiority argument powering the test of the alternative hypothesis of no difference in the rates. Within each co-primary endpoint, the two active treatment groups are assumed to have the same endpoint rates. Total alpha is 0.05 with 0.025 allocated to each co-primary endpoint, which in turn involves comparisons of two active treatment groups to placebo without further alpha control.|Difference in event rates (%)|0.5|||=|0.6241|TWO_SIDED|95.0|-0.7|1.9|||Newcombe-Wilson score method|||||1.9|-0.7|= 0.6241
72376987|NCT02108262|144262747|OTHER||Hazard Ratio (HR)|1.18|||=|0.5733|TWO_SIDED|95.0|0.67|2.05||Stratified log-rank p-value|Log Rank|||||2.05|0.67|= 0.5733
72376988|NCT02108262|144262747|OTHER||Hazard Ratio (HR)|1.02|||=|0.9717|TWO_SIDED|95.0|0.57|1.8||Stratified log-rank p-value|Log Rank|||||1.80|0.57|= 0.9717
72376989|NCT00420641|144262827|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.78||||0.485|TWO_SIDED|90.0|-2.6|1.05|||Mixed Model Repeated Measures (MMRM)||The point estimate was calculated as least square (LS) mean difference (final value) of placebo and GSK372475.|Placebo versus GSK372475 in MADRS total score at Week 10.||1.05|-2.60|0.485
72376990|NCT00420641|144262827|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.99||||0|TWO_SIDED|90.0|-5.75|-2.22|||MMRM||The point estimate was calculated as LS mean difference (final value) of placebo and Paroxetine.|Placebo versus Paroxetine in MADRS total score at Week 10.||-2.22|-5.75|0.000
72376991|NCT00420641|144262828|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.53||||0.252|TWO_SIDED|90.0|-1.28|0.23|||MMRM||The point estimate was calculated as LS mean difference (final value) of placebo and GSK372475.|Placebo versus GSK372475 in Bech score at Week 10.||0.23|-1.28|0.252
72376992|NCT00420641|144262828|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.77||||0|TWO_SIDED|90.0|-2.49|-1.05|||MMRM||The point estimate was calculated as LS mean difference (final value) of placebo and Paroxetine.|Placebo versus Paroxetine in MADRS total score at Week 10.||-1.05|-2.49|0.000
72376993|NCT00420641|144262829|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.66||||0.279|TWO_SIDED|90.0|-4.19|0.87|||MMRM||The point estimate was calculated as LS mean difference (final value) of placebo and GSK372475.|Placebo versus GSK372475 in IDS-CR total score at Week 10.||0.87|-4.19|0.279
72376994|NCT00420641|144262829|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.12||||0.001|TWO_SIDED|90.0|-7.55|-2.68|||MMRM||The point estimate was calculated as LS mean difference (final value) of placebo and Paroxetine.|Placebo versus Paroxetine in IDS-CR total score at Week 10.||-2.68|-7.55|0.001
72376995|NCT00420641|144262830|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.05||||0.287|TWO_SIDED|90.0|-5.23|1.12|||MMRM||The point estimate was calculated as LS mean difference (final value) of placebo and GSK372475.|Placebo versus GSK372475 in IDS-SR total score at Week 10.||1.12|-5.23|0.287
72376996|NCT00420641|144262830|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.23||||0.001|TWO_SIDED|90.0|-9.21|-3.25|||MMRM||The point estimate was calculated as LS mean difference (final value) of placebo and Paroxetine.|Placebo versus Paroxetine in IDS-SR total score at Week 10.||-3.25|-9.21|0.001
72376997|NCT00420641|144262831|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.53||||0.352|TWO_SIDED|90.0|-1.47|0.41|||MMRM||The point estimate was calculated as LS mean difference (final value) of placebo and GSK372475.|Placebo versus GSK372475 in QIDS-CR16 total score at Week 10.||0.41|-1.47|0.352
72376998|NCT00420641|144262831|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.71||||0.002|TWO_SIDED|90.0|-2.62|-0.81|||MMRM||The point estimate was calculated as LS mean difference (final value) of placebo and Paroxetine.|Placebo versus Paroxetine in QIDS-CR16 total score at Week 10.||-0.81|-2.62|0.002
72376999|NCT00420641|144262832|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.03||||0.168|TWO_SIDED|90.0|-2.27|0.2|||MMRM||The point estimate was calculated as LS mean difference (final value) of placebo and GSK372475.|Placebo versus GSK372475 in QIDS-SR16 total score at Week 10.||0.20|-2.27|0.168
72377000|NCT00420641|144262832|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.12||||0.002|TWO_SIDED|90.0|-3.27|-0.97|||MMRM||The point estimate was calculated as LS mean difference (final value) of placebo and Paroxetine.|Placebo versus Paroxetine in QIDS-SR16 total score at Week 10.||-0.97|-3.27|0.002
72377001|NCT00420641|144262833|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.19||||0.257|TWO_SIDED|90.0|-0.46|0.09|||MMRM||The point estimate was calculated as LS mean difference (final value) of placebo and GSK372475.|Placebo versus GSK372475 in MADRS Item 2 score at Week 10.||0.09|-0.46|0.257
72377002|NCT00420641|144262833|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.51||||0.001|TWO_SIDED|90.0|-0.77|-0.25|||MMRM||The point estimate was calculated as LS mean difference (final value) of placebo and Paroxetine.|Placebo versus Paroxetine in MADRS Item 2 score at Week 10.||-0.25|-0.77|0.001
72377003|NCT00420641|144262834|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.17||||0.096|TWO_SIDED|90.0|-0.33|0.0|||MMRM||The point estimate was calculated as LS mean difference (final value) of placebo and GSK372475.|Placebo versus GSK372475 in IDS-CR Item 5 score at Week 10.||-0.00|-0.33|0.096
72377004|NCT00420641|144262834|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.37||||0|TWO_SIDED|90.0|-0.53|-0.22|||MMRM||The point estimate was calculated as LS mean difference (final value) of placebo and Paroxetine.|Placebo versus Paroxetine in IDS-CR Item 5 at Week 10.||-0.22|-0.53|0.000
72377005|NCT00420641|144262835|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.47||||0.576|TWO_SIDED|90.0|-1.84|0.91|||MMRM||The point estimate was calculated as LS mean difference (final value) of placebo and GSK372475.|Placebo versus GSK372475 in HAMD-17 total score at Week 10.||0.91|-1.84|0.576
72377006|NCT00420641|144262835|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.96||||0|TWO_SIDED|90.0|-4.28|-1.64|||MMRM||The point estimate was calculated as LS mean difference (final value) of placebo and Paroxetine.|Placebo versus Paroxetine in HAMD-17 total score at Week 10.||-1.64|-4.28|0.000
72377007|NCT00420641|144262836|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.16||||0.209|TWO_SIDED|90.0|-0.38|0.05|||MMRM||The point estimate was calculated as LS mean difference (final value) of placebo and GSK372475.|Placebo versus GSK372475 in HAMD-17 Item 1 score at Week 10.||0.05|-0.38|0.209
72377008|NCT00420641|144262836|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.39||||0.002|TWO_SIDED|90.0|-0.6|-0.19|||MMRM||The point estimate was calculated as LS mean difference (final value) of placebo and Paroxetine.|Placebo versus Paroxetine in HAMD-17 Item 1 score at Week 10.||-0.19|-0.60|0.002
72377009|NCT00420641|144262837|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.55||||0.175|TWO_SIDED|90.0|-1.23|0.12|||MMRM||The point estimate was calculated as LS mean difference (final value) of placebo and GSK372475.|Placebo versus GSK372475 in IDS-CR 5 Item subscale total score at Week 10.||0.12|-1.23|0.175
72433587|NCT00991276|144380367|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|30.81|STANDARD_ERROR_OF_MEAN|7.42|<|0.0001|TWO_SIDED|95.0|16.14|45.49||This analysis was step 3 in a step-down procedure (if p-value \< 0.05, then continue to next step) used to control the Type I error rate.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||45.49|16.14|<0.0001
72433588|NCT00991276|144380367|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|26.79|STANDARD_ERROR_OF_MEAN|7.34||0.0004|TWO_SIDED|95.0|12.26|41.32||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||41.32|12.26|0.0004
72433589|NCT00991276|144380367|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|4.03|STANDARD_ERROR_OF_MEAN|7.27||0.5807|TWO_SIDED|95.0|-10.36|18.41||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||18.41|-10.36|0.5807
72377010|NCT00420641|144262837|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.15||||0.003|TWO_SIDED|90.0|-1.79|-0.5|||MMRM||The point estimate was calculated as LS mean difference (final value) of placebo and Paroxetine.|Placebo versus Paroxetine in IDS-CR 5 Item subscale total score at Week 10.||-0.50|-1.79|0.003
72377011|NCT00420641|144262837|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.99||||0.082|TWO_SIDED|90.0|-1.92|-0.05|||MMRM||The point estimate was calculated as LS mean difference (final value) of placebo and GSK372475.|Placebo versus GSK372475 in IDS-SR 5 Item subscale total score at Week 10.||-0.05|-1.92|0.082
72377012|NCT00420641|144262837|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.77||||0.001|TWO_SIDED|90.0|-2.64|-0.9|||MMRM||The point estimate was calculated as LS mean difference (final value) of placebo and Paroxetine.|Placebo versus Paroxetine in IDS-SR 5 Item subscale total score at Week 10.||-0.90|-2.64|0.001
72556196|NCT05133180|144643474|SUPERIORITY|Changes from baseline in each IDEEL modules scale score was analyzed by comparing the two treatment groups using a two-sample t-test or a Mann-Whitney-Wilcoxon (Wilson rank sum) test if normality assumption was not met.||||||0.076||||||p-value corresponds to two sample (independent group) t-test of the comparisons between Cenegermin and Vehicle in all participants|t-test, 2 sided|||IDEEL - Satisfaction with Treatment Effectiveness - Week 16||||0.076
72377013|NCT00420641|144262838|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.19||||0.208|TWO_SIDED|90.0|-0.45|0.06|||MMRM||The point estimate was calculated as LS mean difference (final value) of placebo and GSK372475.|Placebo versus GSK372475 in CGI-S score at Week 10.||0.06|-0.45|0.208
72377014|NCT00420641|144262838|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.52||||0|TWO_SIDED|90.0|-0.76|-0.28|||MMRM||The point estimate was calculated as LS mean difference (final value) of placebo and Paroxetine.|Placebo versus Paroxetine in CGI-S score at Week 10.||-0.28|-0.76|0.000
72377015|NCT00420641|144262839|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.76||||0.516|TWO_SIDED|90.0|-2.71|6.24|||MMRM||The point estimate was calculated as LS mean difference (final value) of placebo and GSK372475.|Placebo versus GSK372475 in MEI total score at Week 10.||6.24|-2.71|0.516
72377016|NCT00420641|144262839|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.22||||0.016|TWO_SIDED|90.0|1.97|10.48|||MMRM||The point estimate was calculated as LS mean difference (final value) of placebo and Paroxetine.|Placebo versus Paroxetine in MEI total score at Week 10.||10.48|1.97|0.016
72377017|NCT00420641|144262840|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.72||||0.126|TWO_SIDED|90.0|-0.13|3.57|||MMRM||The point estimate was calculated as LS mean difference (final value) of placebo and GSK372475.|Placebo versus GSK372475 in CSFQ-14SF total score at Week 10.||3.57|-0.13|0.126
72377018|NCT00420641|144262840|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.06||||0.957|TWO_SIDED|90.0|-1.69|1.81|||MMRM||The point estimate was calculated as LS mean difference (final value) of placebo and Paroxetine.|Placebo versus Paroxetine in CSFQ-14SF total score at Week 10.||1.81|-1.69|0.957
72433590|NCT00991276|144380368|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-5.67|STANDARD_ERROR_OF_MEAN|2.09||0.0076|TWO_SIDED|95.0|-9.8|-1.54||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||Stage N1 sleep: P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||-1.54|-9.80|0.0076
72493927|NCT02653768|144516715|SUPERIORITY||Mean Difference (Final Values)|0.4||||0.43|TWO_SIDED|95.0|-0.6|1.3|||Mixed Models Analysis|||This is the analysis between-group difference in change from baseline to 9-month follow-up for the 30 second chair stand.||1.3|-0.6|0.43
72493928|NCT02653768|144516716|OTHER||Mean Difference (Final Values)|-2.3||||0.23|TWO_SIDED|95.0|-6.1|1.5|||Mixed Models Analysis|||||1.5|-6.1|0.23
72493929|NCT01784965|144516717|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
72377019|NCT00420641|144262844|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.64||||0.5061|TWO_SIDED|90.0|0.21|1.93|||Generalized estimating equation model|||Placebo versus GSK372475 in MADRS responders at Week 1.||1.93|0.21|0.5061
72377020|NCT00420641|144262844|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.22||||0.7398|TWO_SIDED|90.0|0.46|3.25|||Generalized estimating equation model|||Placebo versus Paroxetine in MADRS responders at Week 1.||3.25|0.46|0.7398
72377021|NCT00420641|144262844|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.04||||0.9209|TWO_SIDED|90.0|0.52|2.08|||Generalized estimating equation model|||Placebo versus GSK372475 in MADRS responders at Week 2.||2.08|0.52|0.9209
72377022|NCT00420641|144262844|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.56||||0.2908|TWO_SIDED|90.0|0.78|3.13|||Generalized estimating equation model|||Placebo versus Paroxetine in MADRS responders at Week 2.||3.13|0.78|0.2908
72377023|NCT00420641|144262844|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.41||||0.0086|TWO_SIDED|90.0|0.23|0.72|||Generalized estimating equation model|||Placebo versus GSK372475 in MADRS responders at Week 3.||0.72|0.23|0.0086
72377024|NCT00420641|144262844|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.08||||0.8087|TWO_SIDED|90.0|0.64|1.83|||Generalized estimating equation model|||Placebo versus Paroxetine in MADRS responders at Week 3.||1.83|0.64|0.8087
72377025|NCT00420641|144262844|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.31||||0.0002|TWO_SIDED|90.0|0.18|0.52|||Generalized estimating equation model|||Placebo versus GSK372475 in MADRS responders at Week 4.||0.52|0.18|0.0002
72377026|NCT00420641|144262844|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.23||||0.4606|TWO_SIDED|90.0|0.78|1.94|||Generalized estimating equation model|||Placebo versus Paroxetine in MADRS responders at Week 4.||1.94|0.78|0.4606
72377027|NCT00420641|144262844|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.65||||0.1399|TWO_SIDED|90.0|0.4|1.05|||Generalized estimating equation model|||Placebo versus GSK372475 in MADRS responders at Week 5.||1.05|0.40|0.1399
72377028|NCT00420641|144262844|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.73||||0.0461|TWO_SIDED|90.0|1.1|2.73|||Generalized estimating equation model|||Placebo versus Paroxetine in MADRS responders at Week 5.||2.73|1.10|0.0461
72377029|NCT00420641|144262844|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.66||||0.14|TWO_SIDED|90.0|0.41|1.05|||Generalized estimating equation model|||Placebo versus GSK372475 in MADRS responders at Week 6.||1.05|0.41|0.1400
72377030|NCT00420641|144262844|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.71||||0.0002|TWO_SIDED|90.0|1.74|4.21|||Generalized estimating equation model|||Placebo versus Paroxetine in MADRS responders at Week 6.||4.21|1.74|0.0002
72377031|NCT00420641|144262844|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.98||||0.9596|TWO_SIDED|90.0|0.59|1.64|||Generalized estimating equation model|||Placebo versus GSK372475 in MADRS responders at Week 8.||1.64|0.59|0.9596
72377032|NCT00420641|144262844|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.24||||0|TWO_SIDED|90.0|2.01|5.23|||Generalized estimating equation model|||Placebo versus Paroxetine in MADRS responders at Week 8.||5.23|2.01|0.0000
72377033|NCT00420641|144262844|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.15||||0.653|TWO_SIDED|90.0|0.69|1.93|||Generalized estimating equation model|||Placebo versus GSK372475 in MADRS responders at Week 10.||1.93|0.69|0.6530
72377034|NCT00420641|144262844|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.48||||0|TWO_SIDED|90.0|2.11|5.73|||Generalized estimating equation model|||Placebo versus Paroxetine in MADRS responders at Week 10.||5.73|2.11|0.0000
72377035|NCT00420641|144262844|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.89||||0.8844|TWO_SIDED|90.0|0.23|3.48|||Generalized estimating equation model|||Placebo versus GSK372475 in MADRS remitters at Week 1.||3.48|0.23|0.8844
72377036|NCT00420641|144262844|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.29||||0.7425|TWO_SIDED|90.0|0.36|4.68|||Generalized estimating equation model|||Placebo versus Paroxetine in MADRS remitters at Week 1.||4.68|0.36|0.7425
72377037|NCT00420641|144262844|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.9||||0.8355|TWO_SIDED|90.0|0.39|2.07|||Generalized estimating equation model|||Placebo versus GSK372475 in MADRS remitters at Week 2.||2.07|0.39|0.8355
72377038|NCT00420641|144262844|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.93||||0.1786|TWO_SIDED|90.0|0.86|4.32|||Generalized estimating equation model|||Placebo versus Paroxetine in MADRS remitters at Week 2.||4.32|0.86|0.1786
72377039|NCT00420641|144262844|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.5||||0.0835|TWO_SIDED|90.0|0.26|0.97|||Generalized estimating equation model|||Placebo versus GSK372475 in MADRS remitters at Week 3.||0.97|0.26|0.0835
72377040|NCT00420641|144262844|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.07||||0.8558|TWO_SIDED|90.0|0.58|1.98|||Generalized estimating equation model|||Placebo versus Paroxetine in MADRS remitters at Week 3.||1.98|0.58|0.8558
72377041|NCT00420641|144262844|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.36||||0.0067|TWO_SIDED|90.0|0.2|0.67|||Generalized estimating equation model|||Placebo versus GSK372475 in MADRS remitters at Week 4.||0.67|0.20|0.0067
72377042|NCT00420641|144262844|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.15||||0.6647|TWO_SIDED|90.0|0.67|1.98|||Generalized estimating equation model|||Placebo versus Paroxetine in MADRS remitters at Week 4.||1.98|0.67|0.6647
72377043|NCT00420641|144262844|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.98||||0.9553|TWO_SIDED|90.0|0.55|1.74|||Generalized estimating equation model|||Placebo versus GSK372475 in MADRS remitters at Week 5.||1.74|0.55|0.9553
72377044|NCT00420641|144262844|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.58||||0.004||90.0|1.5|4.42|||Generalized estimating equation model|||Placebo versus Paroxetine in MADRS remitters at Week 5.||4.42|1.50|0.0040
72377045|NCT00420641|144262844|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.86||||0.6327|TWO_SIDED|90.0|0.52|1.43|||Generalized estimating equation model|||Placebo versus GSK372475 in MADRS remitters at Week 6.||1.43|0.52|0.6327
72556197|NCT05133180|144643474|SUPERIORITY|Changes from baseline in each IDEEL modules scale score was analyzed by comparing the two treatment groups using a two-sample t-test or a Mann-Whitney-Wilcoxon (Wilson rank sum) test if normality assumption was not met.||||||0.128||||||p-value corresponds to two sample (independent group) t-test of the comparisons between Cenegermin and Vehicle in all participants.|t-test, 2 sided|||IDEEL - Treatment- Related Bother / Inconvenience - Week 16||||0.128
72377046|NCT00420641|144262844|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.36||||0.0027|TWO_SIDED|90.0|1.47|3.79|||Generalized estimating equation model|||Placebo versus Paroxetine in MADRS remitters at Week 6.||3.79|1.47|0.0027
72377047|NCT00420641|144262844|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.76||||0.3961|TWO_SIDED|90.0|0.45|1.29|||Generalized estimating equation model|||Placebo versus GSK372475 in MADRS remitters at Week 8.||1.29|0.45|0.3961
72377048|NCT00420641|144262844|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.89||||0.0298|TWO_SIDED|90.0|1.17|3.06|||Generalized estimating equation model|||Placebo versus Paroxetine in MADRS remitters at Week 8.||3.06|1.17|0.0298
72377049|NCT00420641|144262844|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.95||||0.8826|TWO_SIDED|90.0|0.56|1.61|||Generalized estimating equation model|||Placebo versus GSK372475 in MADRS remitters at Week 10.||1.61|0.56|0.8826
72377050|NCT00420641|144262844|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.48||||0.0022|TWO_SIDED|90.0|1.52|4.05|||Generalized estimating equation model|||Placebo versus Paroxetine in MADRS remitters at Week 10.||4.05|1.52|0.0022
72377051|NCT00420641|144262845|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.65||||0.5072|TWO_SIDED|90.0|0.22|1.89|||Generalized estimating equation model|||Placebo versus GSK372475 in IDS-CR responders at Week 1.||1.89|0.22|0.5072
72377052|NCT00420641|144262845|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.23||||0.6886|TWO_SIDED|90.0|0.52|2.93|||Generalized estimating equation model|||Placebo versus Paroxetine in IDS-CR responders at Week 1.||2.93|0.52|0.6886
72377053|NCT00420641|144262845|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.07||||0.8664|TWO_SIDED|90.0|0.56|2.04|||Generalized estimating equation model|||Placebo versus GSK372475 in IDS-CR responders at Week 2.||2.04|0.56|0.8664
72377054|NCT00420641|144262845|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.5||||0.2897|TWO_SIDED|90.0|0.8|2.79|||Generalized estimating equation model|||Placebo versus Paroxetine in IDS-CR responders at Week 2.||2.79|0.80|0.2897
72377055|NCT00420641|144262845|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.68||||0.2474|TWO_SIDED|90.0|0.39|1.18|||Generalized estimating equation model|||Placebo versus GSK372475 in IDS-CR responders at Week 3.||1.18|0.39|0.2474
72377056|NCT00420641|144262845|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.49||||0.2007|TWO_SIDED|90.0|0.89|2.47|||Generalized estimating equation model|||Placebo versus Paroxetine in IDS-CR responders at Week 3.||2.47|0.89|0.2007
72377057|NCT00420641|144262845|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.49||||0.0214|TWO_SIDED|90.0|0.29|0.82|||Generalized estimating equation model|||Placebo versus GSK372475 in IDS-CR responders at Week 4.||0.82|0.29|0.0214
72377058|NCT00420641|144262845|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.4||||0.2368|TWO_SIDED|90.0|0.88|2.23|||Generalized estimating equation model|||Placebo versus Paroxetine in IDS-CR responders at Week 4.||2.23|0.88|0.2368
72377059|NCT00420641|144262845|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.0||||0.987|TWO_SIDED|90.0|0.63|1.59|||Generalized estimating equation model|||Placebo versus GSK372475 in IDS-CR responders at Week 5.||1.59|0.63|0.9870
72377060|NCT00420641|144262845|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.91||||0.0193|TWO_SIDED|90.0|1.21|3.0|||Generalized estimating equation model|||Placebo versus Paroxetine in IDS-CR responders at Week 5.||3.00|1.21|0.0193
72377061|NCT00420641|144262845|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.94||||0.8351|TWO_SIDED|90.0|0.59|1.5|||Generalized estimating equation model|||Placebo versus GSK372475 in IDS-CR responders at Week 6.||1.50|0.59|0.8351
72377062|NCT00420641|144262845|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.01||||0.0001|TWO_SIDED|90.0|1.9|4.77|||Generalized estimating equation model|||Placebo versus Paroxetine in IDS-CR responders at Week 6.||4.77|1.90|0.0001
72377063|NCT00420641|144262845|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.1||||0.751|TWO_SIDED|90.0|0.67|1.8|||Generalized estimating equation model|||Placebo versus GSK372475 in IDS-CR responders at Week 8.||1.80|0.67|0.7510
72377064|NCT00420641|144262845|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.37||||0.0029|TWO_SIDED|90.0|1.47|3.8|||Generalized estimating equation model|||Placebo versus Paroxetine in IDS-CR responders at Week 8.||3.80|1.47|0.0029
72377065|NCT00420641|144262845|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.53||||0.1707|TWO_SIDED|90.0|0.92|2.55|||Generalized estimating equation model|||Placebo versus GSK372475 in IDS-CR responders at Week 10.||2.55|0.92|0.1707
72377066|NCT00420641|144262845|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.27||||0.0001|TWO_SIDED|90.0|1.99|5.36|||Generalized estimating equation model|||Placebo versus Paroxetine in IDS-CR responders at Week 10.||5.36|1.99|0.0001
72377067|NCT00420641|144262845|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.27||||0.205|TWO_SIDED|90.0|0.05|1.48|||Generalized estimating equation model|||Placebo versus GSK372475 in IDS-CR remitters at Week 1.||1.48|0.05|0.2050
72377068|NCT00420641|144262845|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.36||||0.1735|TWO_SIDED|90.0|0.11|1.24|||Generalized estimating equation model|||Placebo versus Paroxetine in IDS-CR remitters at Week 1.||1.24|0.11|0.1735
72377069|NCT00420641|144262845|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.93||||0.2305|TWO_SIDED|90.0|0.78|4.75|||Generalized estimating equation model|||Placebo versus GSK372475 in IDS-CR remitters at Week 2.||4.75|0.78|0.2305
72377070|NCT00420641|144262845|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.86||||0.2507|TWO_SIDED|90.0|0.77|4.5|||Generalized estimating equation model|||Placebo versus Paroxetine in IDS-CR remitters at Week 2.||4.50|0.77|0.2507
72377071|NCT00420641|144262845|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.76||||0.5608|TWO_SIDED|90.0|0.35|1.64|||Generalized estimating equation model|||Placebo versus GSK372475 in IDS-CR remitters at Week 3.||1.64|0.35|0.5608
72377072|NCT00420641|144262845|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.21||||0.6526|TWO_SIDED|90.0|0.6|2.42|||Generalized estimating equation model|||Placebo versus Paroxetine in IDS-CR remitters at Week 3.||2.42|0.60|0.6526
72377073|NCT00420641|144262845|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.41||||0.0208|TWO_SIDED|90.0|0.21|0.77|||Generalized estimating equation model|||Placebo versus GSK372475 in IDS-CR remitters at Week 4.||0.77|0.21|0.0208
72377074|NCT00420641|144262845|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.69||||0.2859|TWO_SIDED|90.0|0.39|1.22|||Generalized estimating equation model|||Placebo versus Paroxetine in IDS-CR remitters at Week 4.||1.22|0.39|0.2859
72377075|NCT00420641|144262845|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.91||||0.7921|TWO_SIDED|90.0|0.49|1.66|||Generalized estimating equation model|||Placebo versus GSK372475 in IDS-CR remitters at Week 5.||1.66|0.49|0.7921
72556198|NCT02284867|144643524|NON_INFERIORITY_OR_EQUIVALENCE|"Multivariable binary logistic regression was done to examine the relation between CD16+ NK and preterm labor as adjusted for other confounding factors the enter method was used to build the regression model.~A two-sided p-value \<0.05 was considered statistically significant."|Odds Ratio (OR)|65.01|STANDARD_ERROR_OF_MEAN|1.14|<|0.0002|TWO_SIDED|95.0|6.96|606.76||To our best of known , no previous human studies was analyzing this issue|Regression, Logistic|||"Categorical data were presented as number and percentage and differences were compared using the Pearson chi-squared test. Ordinal data were compared using the chi-squared test for trend~A two-sided p-value \<0.05 was considered statistically significant."||606.76|6.96|<0.0002
72377076|NCT00420641|144262845|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.35||||0.362|TWO_SIDED|90.0|0.79|2.31|||Generalized estimating equation model|||Placebo versus Paroxetine in IDS-CR remitters at Week 5.||2.31|0.79|0.3620
72377077|NCT00420641|144262845|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.77||||0.4331|TWO_SIDED|90.0|0.44|1.34|||Generalized estimating equation model|||Placebo versus GSK372475 in IDS-CR remitters at Week 6.||1.34|0.44|0.4331
72377078|NCT00420641|144262845|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.3||||0.0047|TWO_SIDED|90.0|1.42|3.75|||Generalized estimating equation model|||Placebo versus Paroxetine in IDS-CR remitters at Week 6.||3.75|1.42|0.0047
72377079|NCT00420641|144262845|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.78||||0.4431|TWO_SIDED|90.0|0.46|1.32|||Generalized estimating equation model|||Placebo versus GSK372475 in IDS-CR remitters at Week 8.||1.32|0.46|0.4431
72377080|NCT00420641|144262845|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.48||||0.1901|TWO_SIDED|90.0|0.9|2.44|||Generalized estimating equation model|||Placebo versus Paroxetine in IDS-CR remitters at Week 8.||2.44|0.90|0.1901
72377081|NCT00420641|144262845|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.97||||0.9222|TWO_SIDED|90.0|0.56|1.66|||Generalized estimating equation model|||Placebo versus GSK372475 in IDS-CR remitters at Week 10.||1.66|0.56|0.9222
72377082|NCT00420641|144262845|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.5||||0.1665|TWO_SIDED|90.0|0.93|2.43|||Generalized estimating equation model|||Placebo versus Paroxetine in IDS-CR remitters at Week 10.||2.43|0.93|0.1665
72377083|NCT00420641|144262846|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.63||||0.5057|TWO_SIDED|90.0|0.2|1.98|||Generalized estimating equation model|||Placebo versus GSK372475 in HAMD-17 responders at Week 1.||1.98|0.20|0.5057
72377084|NCT00420641|144262846|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.12||||0.8633|TWO_SIDED|90.0|0.38|3.3|||Generalized estimating equation model|||Placebo versus Paroxetine in HAMD-17 responders at Week 1.||3.30|0.38|0.8633
72377085|NCT00420641|144262846|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.09||||0.8428|TWO_SIDED|90.0|0.55|2.16|||Generalized estimating equation model|||Placebo versus GSK372475 in HAMD-17 responders at Week 2.||2.16|0.55|0.8428
72377086|NCT00420641|144262846|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.47||||0.3416|TWO_SIDED|90.0|0.76|2.84|||Generalized estimating equation model|||Placebo versus Paroxetine in HAMD-17 responders at Week 2.||2.84|0.76|0.3416
72377087|NCT00420641|144262846|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.71||||0.3287|TWO_SIDED|90.0|0.4|1.26|||Generalized estimating equation model|||Placebo versus GSK372475 in HAMD-17 responders at Week 3.||1.26|0.40|0.3287
72377088|NCT00420641|144262846|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.5||||0.2112|TWO_SIDED|90.0|0.88|2.57|||Generalized estimating equation model|||Placebo versus Paroxetine in HAMD-17 responders at Week 3.||2.57|0.88|0.2112
72377089|NCT00420641|144262846|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.44||||0.0134|TWO_SIDED|90.0|0.26|0.76|||Generalized estimating equation model|||Placebo versus GSK372475 in HAMD-17 responders at Week 4.||0.76|0.26|0.0134
72377090|NCT00420641|144262846|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.33||||0.3412|TWO_SIDED|90.0|0.81|2.17|||Generalized estimating equation model|||Placebo versus Paroxetine in HAMD-17 responders at Week 4.||2.17|0.81|0.3412
72377091|NCT00420641|144262846|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.94||||0.8434|TWO_SIDED|90.0|0.58|1.54|||Generalized estimating equation model|||Placebo versus GSK372475 in HAMD-17 responders at Week 5.||1.54|0.58|0.8434
72377092|NCT00420641|144262846|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.65||||0.0819|TWO_SIDED|90.0|1.03|2.63|||Generalized estimating equation model|||Placebo versus Paroxetine in HAMD-17 responders at Week 5.||2.63|1.03|0.0819
72377093|NCT00420641|144262846|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.72||||0.2832|TWO_SIDED|90.0|0.44|1.19|||Generalized estimating equation model|||Placebo versus GSK372475 in HAMD-17 responders at Week 6.||1.19|0.44|0.2832
72377094|NCT00420641|144262846|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.47||||0.0016|TWO_SIDED|90.0|1.54|3.97|||Generalized estimating equation model|||Placebo versus Paroxetine in HAMD-17 responders at Week 6.||3.97|1.54|0.0016
72377095|NCT00420641|144262846|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.99||||0.9727|TWO_SIDED|90.0|0.6|1.63|||Generalized estimating equation model|||Placebo versus GSK372475 in HAMD-17 responders at Week 8.||1.63|0.60|0.9727
72377096|NCT00420641|144262846|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.57||||0.001|TWO_SIDED|90.0|1.6|4.13|||Generalized estimating equation model|||Placebo versus Paroxetine in HAMD-17 responders at Week 8.||4.13|1.60|0.0010
72377097|NCT00420641|144262846|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.07||||0.8312|TWO_SIDED|90.0|0.64|1.8|||Generalized estimating equation model|||Placebo versus GSK372475 in HAMD-17 responders at Week 10.||1.80|0.64|0.8312
72377098|NCT00420641|144262846|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.06||||0.0002|TWO_SIDED|90.0|1.86|5.02|||Generalized estimating equation model|||Placebo versus Paroxetine in HAMD-17 responders at Week 10.||5.02|1.86|0.0002
72377099|NCT00420641|144262846|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.58||||0.553|TWO_SIDED|90.0|0.13|2.6|||Generalized estimating equation model|||Placebo versus GSK372475 in HAMD-17 remitters at Week 1.||2.60|0.13|0.5530
72377100|NCT00420641|144262846|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.98||||0.978|TWO_SIDED|90.0|0.28|3.41|||Generalized estimating equation model|||Placebo versus Paroxetine in HAMD-17 remitters at Week 1.||3.41|0.28|0.9780
72377101|NCT00420641|144262846|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.14||||0.8312|TWO_SIDED|90.0|0.43|3.03|||Generalized estimating equation model|||Placebo versus GSK372475 in HAMD-17 remitters at Week 2.||3.03|0.43|0.8312
72433591|NCT00991276|144380368|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-10.32|STANDARD_ERROR_OF_MEAN|2.08|<|0.0001|TWO_SIDED|95.0|-14.43|-6.21||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||Stage N1 sleep: P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||-6.21|-14.43|<0.0001
72433592|NCT00991276|144380368|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|4.65|STANDARD_ERROR_OF_MEAN|2.06||0.0257|TWO_SIDED|95.0|0.58|8.73||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||Stage N1 sleep: P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||8.73|0.58|0.0257
72377102|NCT00420641|144262846|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.09||||0.1881|TWO_SIDED|90.0|0.83|5.25|||Generalized estimating equation model|||Placebo versus Paroxetine in HAMD-17 remitters at Week 2.||5.25|0.83|0.1881
72377103|NCT00420641|144262846|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.81||||0.6384|TWO_SIDED|90.0|0.39|1.69|||Generalized estimating equation model|||Placebo versus GSK372475 in HAMD-17 remitters at Week 3.||1.69|0.39|0.6384
72377104|NCT00420641|144262846|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.68||||0.216|TWO_SIDED|90.0|0.84|3.37|||Generalized estimating equation model|||Placebo versus Paroxetine in HAMD-17 remitters at Week 3.||3.37|0.84|0.2160
72377105|NCT00420641|144262846|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.4||||0.0259|TWO_SIDED|90.0|0.2|0.79|||Generalized estimating equation model|||Placebo versus GSK372475 in HAMD-17 remitters at Week 4.||0.79|0.20|0.0259
72377106|NCT00420641|144262846|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.73||||0.3959|TWO_SIDED|90.0|0.39|1.35|||Generalized estimating equation model|||Placebo versus Paroxetine in HAMD-17 remitters at Week 4.||1.35|0.39|0.3959
72377107|NCT00420641|144262846|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.72||||0.3857|TWO_SIDED|90.0|0.39|1.34|||Generalized estimating equation model|||Placebo versus GSK372475 in HAMD-17 remitters at Week 5.||1.34|0.39|0.3857
72377108|NCT00420641|144262846|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.42||||0.3126|TWO_SIDED|90.0|0.8|2.52|||Generalized estimating equation model|||Placebo versus Paroxetine in HAMD-17 remitters at Week 5.||2.52|0.80|0.3126
72377109|NCT00420641|144262846|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.61||||0.1182|TWO_SIDED|90.0|0.36|1.03|||Generalized estimating equation model|||Placebo versus GSK372475 in HAMD-17 remitters at Week 6.||1.03|0.36|0.1182
72377110|NCT00420641|144262846|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.1||||0.0125|TWO_SIDED|90.0|1.29|3.43|||Generalized estimating equation model|||Placebo versus Paroxetine in HAMD-17 remitters at Week 6.||3.43|1.29|0.0125
72377111|NCT00420641|144262846|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.69||||0.2147|TWO_SIDED|90.0|0.42|1.13|||Generalized estimating equation model|||Placebo versus GSK372475 in HAMD-17 remitters at Week 8.||1.13|0.42|0.2147
72377112|NCT00420641|144262846|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.67||||0.0783|TWO_SIDED|90.0|1.03|2.69|||Generalized estimating equation model|||Placebo versus Paroxetine in HAMD-17 remitters at Week 8.||2.69|1.03|0.0783
72377113|NCT00420641|144262846|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.96||||0.9067||90.0|0.57|1.64|||Generalized estimating equation model|||Placebo versus GSK372475 in HAMD-17 remitters at Week 10.||1.64|0.57|0.9067
72377114|NCT00420641|144262846|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.83||||0.0328|TWO_SIDED|90.0|1.15|2.92|||Generalized estimating equation model|||Placebo versus Paroxetine in HAMD-17 remitters at Week 10.||2.92|1.15|0.0328
72493930|NCT05215600|144516751|OTHER|P-values account for preoperative versus postoperative mean values at 1 and 2 years|||||<|0.001|||||||t-test, 2 sided|T-Test (Pooled)||||||<0.001
72493931|NCT05215600|144516752|OTHER|P-values account for preoperative versus postoperative mean values at 1 and 2 years|||||<|0.001|||||||t-test, 2 sided|T-Test (Pooled)||||||<0.001
72618406|NCT01292473|144767759|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-3.79||||0.0004|TWO_SIDED|95.0|-5.85|-1.73||Refer to the Type-I error control plan.|ANCOVA|Covariates included in the analysis were baseline overall DLQI score (\< median vs ≥ median) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis is that there is no difference between the placebo and omalizumab 300 mg groups.||-1.73|-5.85|0.0004
72377115|NCT00420641|144262847|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.29||||0.6928|TWO_SIDED|90.0|0.44|3.76|||Generalized estimating equation model|||Placebo versus GSK372475 in percentage of participants with CGI-I at Week 1.||3.76|0.44|0.6928
72377116|NCT00420641|144262847|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.86||||0.3039|TWO_SIDED|90.0|0.69|5.01|||Generalized estimating equation model|||Placebo versus Paroxetine in percentage of participants with CGI-I at Week 1.||5.01|0.69|0.3039
72377117|NCT00420641|144262847|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.55||||0.1938|TWO_SIDED|90.0|0.89|2.7|||Generalized estimating equation model|||Placebo versus GSK372475 in percentage of participants with CGI-I at Week 2.||2.70|0.89|0.1938
72377118|NCT00420641|144262847|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.85||||0.06|TWO_SIDED|90.0|1.08|3.16|||Generalized estimating equation model|||Placebo versus Paroxetine in percentage of participants with CGI-I at Week 2.||3.16|1.08|0.0600
72377119|NCT00420641|144262847|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.96||||0.8989|TWO_SIDED|90.0|0.61|1.53|||Generalized estimating equation model|||Placebo versus GSK372475 in percentage of participants with CGI-I at Week 3.||1.53|0.61|0.8989
72377120|NCT00420641|144262847|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.95||||0.0136|TWO_SIDED|90.0|1.25|3.05|||Generalized estimating equation model|||Placebo versus Paroxetine in percentage of participants with CGI-I at Week 3.||3.05|1.25|0.0136
72377121|NCT00420641|144262847|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.77||||0.3099|TWO_SIDED|90.0|0.5|1.18|||Generalized estimating equation model|||Placebo versus GSK372475 in percentage of participants with CGI-I at Week 4.||1.18|0.50|0.3099
72377122|NCT00420641|144262847|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.49||||0.1137|TWO_SIDED|90.0|0.98|2.27|||Generalized estimating equation model|||Placebo versus Paroxetine in percentage of participants with CGI-I at Week 4.||2.27|0.98|0.1137
72377123|NCT00420641|144262847|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.05||||0.8682||90.0|0.67|1.64|||Generalized estimating equation model|||Placebo versus GSK372475 in percentage of participants with CGI-I at Week 5.||1.64|0.67|0.8682
72377124|NCT00420641|144262847|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.56||||0.0006|TWO_SIDED|90.0|1.63|4.03|||Generalized estimating equation model|||Placebo versus Paroxetine in percentage of participants with CGI-I at Week 5.||4.03|1.63|0.0006
72377125|NCT00420641|144262847|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.97||||0.8992|TWO_SIDED|90.0|0.62|1.51|||Generalized estimating equation model|||Placebo versus GSK372475 in percentage of participants with CGI-I at Week 6.||1.51|0.62|0.8992
72377126|NCT00420641|144262847|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.61||||0.0004|TWO_SIDED|90.0|1.67|4.09|||Generalized estimating equation model|||Placebo versus Paroxetine in percentage of participants with CGI-I at Week 6.||4.09|1.67|0.0004
72377127|NCT00420641|144262847|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.37||||0.28|TWO_SIDED|90.0|0.85|2.23|||Placebo versus GSK372475 in percentage o|||Placebo versus GSK372475 in percentage of participants with CGI-I at Week 8.||2.23|0.85|0.2800
72377128|NCT00420641|144262847|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.69||||0|TWO_SIDED|90.0|2.24|6.08|||Generalized estimating equation model|||Placebo versus Paroxetine in percentage of participants with CGI-I at Week 8.||6.08|2.24|0.0000
72377129|NCT00420641|144262847|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.86||||0.0507|TWO_SIDED|90.0|1.1|3.13|||Generalized estimating equation model|||Placebo versus GSK372475 in percentage of participants with CGI-I at Week 10.||3.13|1.10|0.0507
72377130|NCT00420641|144262847|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.97||||0.0003|TWO_SIDED|90.0|1.81|4.88|||Generalized estimating equation model|||Placebo versus Paroxetine in percentage of participants with CGI-I at Week 10.||4.88|1.81|0.0003
72377131|NCT00420641|144262848|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.96||||0.8782|TWO_SIDED|90.0|0.62|1.5|||Regression, Logistic|||Placebo versus GSK372475 in percentage of participants Satisfied with Study Medication at Week 10.||1.50|0.62|0.8782
72377132|NCT00420641|144262848|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.45||||0.0011|TWO_SIDED|90.0|1.56|3.86|||Regression, Logistic|||Placebo versus Paroxetine in percentage of participants Satisfied with Study Medication at Week 10.||3.86|1.56|0.0011
72377133|NCT02815280|144262860|SUPERIORITY||Mean Difference (Final Values)|3.15|STANDARD_ERROR_OF_MEAN|1.12||0.0051|TWO_SIDED|95.0|0.95|5.35|||ANCOVA|||Change from baseline in inflammatory lesion count was analyzed using an analysis of covariance (ANCOVA) model, which included treatment, baseline inflammatory lesion count and pooled investigational site as a blocking factor.||5.35|0.95|0.0051
72377134|NCT02815280|144262861|SUPERIORITY|P-value is for the null hypothesis that the combined log (Risk Ratio) equals 0.|Risk ratio|1.88|STANDARD_ERROR_OF_MEAN|0.31||0.0424|TWO_SIDED|95.0|1.02|3.46|||Mantel Haenszel|||||3.46|1.02|0.0424
72377135|NCT02815280|144262862|SUPERIORITY||Mean Difference (Final Values)|12.84|STANDARD_ERROR_OF_MEAN|5.3||0.0155|TWO_SIDED|95.0|2.44|23.23||Percent change from baseline was analyzed using an ANCOVA model, which included treatment, baseline non-inflammatory lesion counts and pooled investigational site as a blocking factor. For the superiority comparison between FMX101 4% and vehicle.|ANCOVA|||||23.23|2.44|0.0155
72377136|NCT02815280|144262863|SUPERIORITY|Change from baseline in inflammatory lesion count for Week 6 was analyzed using an ANCOVA model, which included treatment, baseline inflammatory lesion counts and pooled investigational site as a blocking factor.|Mean Difference (Final Values)|3.89|STANDARD_ERROR_OF_MEAN|1.03||0.0001|TWO_SIDED|95.0|1.88|5.9|||ANCOVA|||||5.90|1.88|0.0001
72377137|NCT02815280|144262863|SUPERIORITY|Change from baseline in inflammatory lesion count for Week 9 was analyzed using an ANCOVA model, which included treatment, baseline inflammatory lesion counts and pooled investigational site as a blocking factor.|Mean Difference (Final Values)|3.78|STANDARD_ERROR_OF_MEAN|1.11||0.0007|TWO_SIDED|95.0|1.6|5.95|||ANCOVA|||||5.95|1.60|0.0007
72377138|NCT02815280|144262864|SUPERIORITY|P-value is for the null hypothesis that the combined log (Risk Ratio) equals 0. Percentage of participants achieving IGA treatment success at Week 6.|Risk Difference (RD)|3.87|STANDARD_ERROR_OF_MEAN|1.44||0.0071|TWO_SIDED|95.0|1.06|6.69|||Cochran-Mantel-Haenszel|||||6.69|1.06|0.0071
72377139|NCT02815280|144262864|SUPERIORITY||Risk Difference (RD)|1.64|STANDARD_ERROR_OF_MEAN|2.52||0.5143|TWO_SIDED|95.0|-3.3|6.58|||Cochran-Mantel-Haenszel|||||6.58|-3.30|0.5143
72377140|NCT00603642|144262866|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
72377141|NCT00603642|144262867|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||Fisher Exact|||||||<0.0001
72377142|NCT00603642|144262868|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0003|||||||ANCOVA|||||||0.0003
72377143|NCT00603642|144262869|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
72377144|NCT00603642|144262870|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6015|||||||Fisher Exact|||||||0.6015
72377145|NCT02514473|144262886|SUPERIORITY||Least Square (LS) Mean Difference|-1.09|||<|0.0001|TWO_SIDED|95.0|-1.43|-0.75|||MMRM|||Analysis was performed using mixed-effects model for repeated measures (MMRM). The model included treatment, visit and treatment-by-visit interaction as fixed effects; and participant as a random effect with adjustments for baseline, weight (less than \[\<\] 25 kilogram \[kg\] versus greater than or equal to \[\>=\] 25 kg) and percent predicted forced expiratory volume in 1 second (FEV1) severity (\<90 versus \>=90) at screening.||-0.75|-1.43|< 0.0001
72377146|NCT01607203|144262909|NON_INFERIORITY_OR_EQUIVALENCE|t -test||||||0.04|TWO_SIDED||||||Fisher Exact|||||||0.04
72377147|NCT00579436|144262929|SUPERIORITY|||||||0.05|||||||t-test, 2 sided|||||||.05
72377148|NCT00579436|144262930|SUPERIORITY|||||||0.05|||||||t-test, 2 sided|||||||0.05
72618407|NCT01292473|144767760|SUPERIORITY_OR_OTHER|||||||0.1361||||||Refer to the Type-I error control plan. The p-value was not evaluated for statistical significance in accordance with the Type I error control plan provided in the Detailed Description.|Stratified Wilcoxon|Stratification variables included in the analysis were presence of angioedema at baseline (yes vs no) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis is that there is no difference between the placebo and omalizumab 75 mg groups.||||0.1361
72377149|NCT00579436|144262931|SUPERIORITY|||||||0.5|||||||t-test, 2 sided|||||||0.5
72377150|NCT00579436|144262932|SUPERIORITY|||||||0.5|||||||t-test, 2 sided|||||||0.5
72377151|NCT02312882|144262933|OTHER||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
72377152|NCT02025556|144262956|SUPERIORITY||Mean Difference (Final Values)|-2.81|STANDARD_ERROR_OF_MEAN|0.64|<|0.0001|TWO_SIDED|95.0|-4.07|-1.55||The threshold for statistical significance was p = .05.|Mixed Models Analysis|||||-1.55|-4.07|< .0001
72377153|NCT02025556|144262956|SUPERIORITY||Mean Difference (Final Values)|-2.64|STANDARD_ERROR_OF_MEAN|0.64|<|0.0001|TWO_SIDED|95.0|-3.9|-1.38||The threshold for statistical significance was p = .05.|Mixed Models Analysis|||||-1.38|-3.9|< .0001
72377154|NCT01894568|144262968|NON_INFERIORITY_OR_EQUIVALENCE|0.4% is the margin of Non-inferiority|LS Mean Difference|-0.24||||0.005|TWO_SIDED|95.0|-0.41|-0.07|||Mixed Models Analysis|||||-0.07|-0.41|0.005
72377155|NCT04545944|144262986|OTHER||Geometric Least Squares Mean Ratio|192.4|||||TWO_SIDED|90.0|152.8|242.4||||||A linear mixed model with treatment as a fixed effect and participant as a random effect was performed on the natural log-transformed values to assess the effect of vonoprazan on the PK of midazolam.||242.4|152.8|
72377156|NCT04545944|144262987|OTHER||Geometric Least Squares Mean Ratio|188.9|||||TWO_SIDED|90.0|150.6|236.9||||||A linear mixed model with treatment as a fixed effect and participant as a random effect was performed on the natural log-transformed values to assess the effect of vonoprazan on the PK of midazolam.||236.9|150.6|
72377157|NCT04545944|144262988|OTHER||Geometric Least Squares Mean Ratio|193.4|||||TWO_SIDED|90.0|160.5|233.1||||||A linear mixed model with treatment as a fixed effect and participant as a random effect was performed on the natural log-transformed values to assess the effect of vonoprazan on the PK of midazolam.||233.1|160.5|
72618408|NCT01292473|144767760|SUPERIORITY_OR_OTHER|||||||0.0905||||||Refer to the Type-I error control plan.|Stratified Wilcoxon|Stratification variables included in the analysis were presence of angioedema at baseline (yes vs no) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis is that there is no difference between the placebo and omalizumab 150 mg groups.||||0.0905
72377158|NCT01514370|144262994|OTHER|||||||0.271|||||||Chi-squared|||||||0.271
72377159|NCT01551420|144263015|SUPERIORITY|Null hypothesis of no change after home use|Mean Difference (Net)|0.002|STANDARD_DEVIATION|0.68||0.9358|TWO_SIDED|95.0|-0.27|0.28||Two way comparison between scores at baseline and after 9-12 weeks of Prosthetic use. Alpha=0.05|t-test, 2 sided|paired t-tests||||0.28|-0.27|.9358
72377160|NCT01551420|144263015|SUPERIORITY||Slope|-0.69||||0.08|TWO_SIDED|95.0|-1.47|0.09|||Regression, Linear|||Linear regression of QOL measure at 9-12 weeks, comparing groups by control type, controlling for amputation level (transhumeral or transradial). Persons with shoulder level devices are excluded from this analysis.||0.09|-1.47|0.08
72377161|NCT01551420|144263016|SUPERIORITY||Mean Difference (Net)|0.3|STANDARD_DEVIATION|0.42|<|0.0001|TWO_SIDED|95.0|0.17|0.43|||t-test, 2 sided|The sample for this analyses was 44 participants.|Mean difference is the change in scores from baseline to End of A.|Pairwise t-test for data from prosthesis users at baseline and completers at End of A (i.e participants with UEFS data at both time points).||0.43|0.17|<0.0001
72433593|NCT00991276|144380368|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|22.7|STANDARD_ERROR_OF_MEAN|6.05||0.0003|TWO_SIDED|95.0|10.74|34.67||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||Stage N2 sleep: P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||34.67|10.74|0.0003
72377162|NCT01551420|144263016|SUPERIORITY||Slope|-0.56|STANDARD_ERROR_OF_MEAN|0.08|<|0.0001|TWO_SIDED|95.0|-0.73|-0.4|||Regression, Linear|The sample for this analysis was 23 participants with TR or TH amputation level who completed data collection for UEFS at End of Part B.|Effect of EMG-PR (compared to IMU group)|Linear regression of scores from UEFS use measure at 9-12 weeks (End of B), comparing groups by control type, and controlling for amputation level (transhumeral or transradial). Persons with shoulder level devices are excluded from this analysis.||-0.40|-0.73|<0.0001
72377163|NCT01551420|144263017|SUPERIORITY||Mean Difference (Net)|-0.22|STANDARD_DEVIATION|0.94||0.186|TWO_SIDED|95.0|-0.55|0.11|||t-test, 2 sided|The sample for this analysis was 34 participants.|Mean difference is the change in scores from baseline to End of A.|Pairwise t-test for data from prosthesis users at baseline and completers at End of A (i.e participants with TAPES data at both time points).||0.11|-0.55|0.186
72377164|NCT01551420|144263017|SUPERIORITY||Slope|-1.15|STANDARD_ERROR_OF_MEAN|0.44||0.0168|TWO_SIDED|95.0|-2.06|-0.23|||Regression, Linear|The sample for this analysis was 24 participants with TR or TH amputation level who completed data collection for TAPES at End of Part B.|Effect of EMG-PR (compared to IMU group)|Linear regression of scores from TAPES measure at 9-12 weeks (End of B), comparing groups by control type, and controlling for amputation level (transhumeral or transradial). Persons with shoulder level devices are excluded from this analysis.||-0.23|-2.06|0.0168
72377165|NCT01551420|144263018|SUPERIORITY||Mean Difference (Net)|-0.97|STANDARD_DEVIATION|5.61||0.3367|TWO_SIDED|95.0|-2.99|1.05|||t-test, 2 sided|The sample for this paired t-test was 43 participants.|Mean difference is the change in scores from baseline to End of A.|Pairwise t-test for data from prosthesis users at baseline and completers at End of A (i.e. participants with UEFS data at both time points).||1.05|-2.99|0.3367
72377166|NCT01551420|144263018|SUPERIORITY||Slope|-0.72|STANDARD_ERROR_OF_MEAN|1.49||0.6339|TWO_SIDED|95.0|-3.84|2.39|||Regression, Linear|The sample for this analysis was 22 participants with TR or TH amputation level who completed data collection for UEFS at End of Part B.|Effect of EMG-PR (compared to IMU group)|Linear regression of scores from AM-ULA measure at 9-12 weeks (End of B), comparing groups by control type, and controlling for amputation level (transhumeral or transradial). Persons with shoulder level devices are excluded from this analysis.||2.39|-3.84|0.6339
72377167|NCT01551420|144263019|SUPERIORITY||Mean Difference (Net)|-1.74|STANDARD_DEVIATION|18.8||0.5465|TWO_SIDED|95.0|-7.53|4.05|||t-test, 2 sided|The sample for this paired t-test was 43 participants.|Mean difference is the change in scores from baseline to End of A.|Pairwise t-test for data for participants at baseline and completers at End of A (i.e participants with SF-36V Role Physical data at both time points).||4.05|-7.53|0.5465
72377168|NCT01551420|144263019|SUPERIORITY||Mean Difference (Net)|-3.78|STANDARD_DEVIATION|17.37||0.161|TWO_SIDED|95.0|-9.12|1.57|||t-test, 2 sided|The sample for this paired t-test was 43 participants.|Mean difference is the change in scores from baseline to End of A.|Pairwise t-test for data for participants at baseline to End of A (with SF-36V Social Functioning data at both time points).||1.57|-9.12|0.1610
72377169|NCT01551420|144263019|SUPERIORITY||Mean Difference (Net)|-0.61|STANDARD_DEVIATION|13.9||0.7765|TWO_SIDED|95.0|-4.9|3.68|||t-test, 2 sided|The sample for this paired t-test was 43 participants.|Mean difference is the change in scores from baseline to End of A.|Pairwise t-test for data for participants at baseline to End of A (with SF-36V Physical Functioning data at both time points).||3.68|-4.90|0.7765
72395127|NCT02289690|144296684|OTHER||RP2D for veliparib in mg BID for 14 days|240.0|||||TWO_SIDED||||||||The RP2D for veliparib was determined to be 240 mg BID for 14 days with carboplatin (AUC 5 mg/mL\*min) on Day 1 and etoposide (100 mg/m²) on Days 1 to 3 during 21-day cycles for 4 cycles.|A primary objective of Phase 1 was to establish the recommended phase 2 dose (RP2D) for veliparib combined with carboplatin and etoposide. The RP2D was determined by the rate of DLTs and overall tolerability of veliparib plus carboplatin and etoposide.||||
72493932|NCT04175626|144516754|SUPERIORITY||||||<|0.0001|||||||Exact, binomial|||The primary endpoint was evaluated by performing an exact, binomial test comparing the rate of TLF for the Orsiro stent at 1 year to a performance goal of 6.9%, with Type I error (alpha) of 0.025 and power of 80%. The null hypothesis (Ho) was stated as: The TLF rate of the Orsiro stent at 1 year is greater than or equal to 6.9%. The alternative hypothesis (Ha) was stated as: The TLF rate of the Orsiro stent at 1 year is less than 6.9%.||||<0.0001
72556199|NCT03930732|144643534|SUPERIORITY|A hierarchical testing procedure was used to control type I error and handle primary and a few secondary endpoint analyses at a 2-sided significance level of 0.049. Testing was then performed sequentially in the order the endpoints are reported (till OM 9). The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.049 level.|Risk Difference (RD)|-0.324||||0.0005|TWO_SIDED|95.0|-0.508|-0.14|||Negative binomial model||Derived using delta method.|Derived using negative binomial model with the total number of the events occurring during the 52-week treatment period as the response variable, and treatment group, region (pooled country), inhaled corticosteroid (ICS) dose, smoking status at screening, baseline disease severity, and number of moderate or severe COPD exacerbation events within one year prior to the study as covariates, and log-transformed treatment duration as an offset variable.||-0.140|-0.508|0.0005
72556200|NCT03930732|144643535|SUPERIORITY||Least Square (LS) Mean Difference|0.083|||<|0.0001|TWO_SIDED|95.0|0.042|0.125||Threshold for significance at 0.049 level.|MMRM model|||Derived from mixed-effect model with repeated measures (MMRM) model with the change from baseline in pre-BD FEV1 up to Week 12 as response variables, and treatment group, age, sex, height, region (pooled country), ICS dose, smoking status at screening, visit, treatment-by-visit interaction, baseline pre-BD FEV1, and FEV1 baseline-by-visit interaction as covariates. Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||0.125|0.042|<0.0001
72556201|NCT03930732|144643536|SUPERIORITY||LS Mean Difference|0.083||||0.0003|TWO_SIDED|95.0|0.038|0.128||Threshold for significance at 0.049 level.|MMRM model|||Derived from MMRM model with the change from baseline in pre-BDFEV1 up to Week 52 as response variables, and treatment group, age, sex, height, region (pooled country), ICS dose, smoking status at screening, visit, treatment-by-visit interaction, baseline pre-BD FEV1, and FEV1 baseline-by-visit interaction as covariates. Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||0.128|0.038|0.0003
72556202|NCT03930732|144643537|SUPERIORITY||LS Mean Difference|0.124||||0.0022|TWO_SIDED|95.0|0.045|0.203||Threshold for significance at 0.049 level.|MMRM model|||Derived from MMRM model with the change from baseline in pre-BD FEV1 up to Week 12 as response variables, and treatment group, age, sex, height, region (pooled country), ICS dose, smoking status at screening, visit, treatment-by-visit interaction, baseline pre-BD FEV1, and FEV1 baseline-by-visit interaction as covariates. Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||0.203|0.045|0.0022
72556203|NCT03930732|144643538|SUPERIORITY||LS Mean Difference|0.127||||0.0034|TWO_SIDED|95.0|0.042|0.212||Threshold for significance at 0.049 level.|MMRM model|||Derived from MMRM model with the change from baseline in pre-BD FEV1 up to Week 52 as response variables, and treatment group, age, sex, height, region (pooled country), ICS dose, smoking status at screening, visit, treatment-by-visit interaction, baseline pre-BD FEV1, and FEV1 baseline-by-visit interaction as covariates. Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||0.212|0.042|0.0034
72377170|NCT01551420|144263019|SUPERIORITY||Slope|-13.35|STANDARD_ERROR_OF_MEAN|6.91||0.0669|TWO_SIDED|95.0|-27.72|1.02|||Regression, Linear|The sample for this analysis was 23 participants with TR or TH amputation level who completed data collection for SF-36 at End of Part B.|Effect of EMG-PR (compared to IMU group)|Linear regression of SF-36V; Role Physical measure at 9-12 weeks, comparing groups by control type, controlling for amputation level (transhumeral or transradial). Persons with shoulder level devices are excluded from this analysis.||1.02|-27.72|0.0669
72377171|NCT01551420|144263019|SUPERIORITY||Slope|-8.24|STANDARD_ERROR_OF_MEAN|7.1||0.2592|TWO_SIDED|95.0|-23.01|6.54|||Regression, Linear|The sample for this analysis was 23 participants with TR or TH amputation level who completed data collection for SF-36 at End of Part B.|Effect of EMG-PR (compared to IMU group)|Linear regression of SF-36V: Social Functioning measure at 9-12 weeks, comparing groups by control type, controlling for amputation level (transhumeral or transradial). Persons with shoulder level devices are excluded from this analysis.||6.54|-23.01|0.2592
72377172|NCT01551420|144263019|SUPERIORITY||Slope|-30.23|STANDARD_ERROR_OF_MEAN|6.25|<|0.0001|TWO_SIDED|95.0|-43.23|-17.23|||Regression, Linear|The sample for this analysis was 23 participants with TR or TH amputation level who completed data collection for SF-36 at End of Part B.|Effect of EMG-PR (compared to IMU group)|Linear regression of SF-36V: Physical Functioning measure at 9-12 weeks, comparing groups by control type, controlling for amputation level (transhumeral or transradial). Persons with shoulder level devices are excluded from this analysis.||-17.23|-43.23|<0.0001
72377173|NCT01551420|144263020|SUPERIORITY||Mean Difference (Net)|0.01|STANDARD_DEVIATION|0.17||0.6691|TWO_SIDED|95.0|-0.05|0.07|||t-test, 2 sided|The sample for this paired t-test was 31 participants.|Mean difference is the change in scores from baseline to End of A.|Pairwise t-test for data from prosthesis users at baseline and completers at End of A (i.e. participants with JTHFT: Writing data at both time points).||0.07|-0.05|0.6691
72377174|NCT01551420|144263020|SUPERIORITY||Mean Difference (Net)|-0.02|STANDARD_DEVIATION|0.06||0.0511|TWO_SIDED|95.0|-0.05|0.0|||t-test, 2 sided|The sample for this paired t-test was 31 participants.|Mean difference is the change in scores from baseline to End of A.|Pairwise t-test for data from prosthesis users at baseline and completers at End of A (i.e. participants with JTHFT: Page turning data at both time points).||0.00|-0.05|0.0511
72377175|NCT01551420|144263020|SUPERIORITY||Mean Difference (Net)|0.01|STANDARD_DEVIATION|0.09||0.5942|TWO_SIDED|95.0|-0.02|0.04|||t-test, 2 sided|The sample for this paired t-test was 31 participants.|Mean difference is the change in scores from baseline to End of A.|Pairwise t-test for data from prosthesis users at baseline and completers at End of A (i.e. participants with JTHFT: Lifting Small Items data at both time points).||0.04|-0.02|0.5942
72377176|NCT01551420|144263020|SUPERIORITY||Mean Difference (Net)|-0.05|STANDARD_DEVIATION|0.08||0.0101|TWO_SIDED|95.0|-0.07|-0.01|||t-test, 2 sided|The sample for this paired t-test was 31 participants.|Mean difference is the change in scores from baseline to End of A.|Pairwise t-test for data from prosthesis users at baseline and completers at End of A (i.e. participants with JTHFT: Checkers data at both time points).||-0.01|-0.07|0.0101
72377177|NCT01551420|144263020|SUPERIORITY||Mean Difference (Net)|-0.03|STANDARD_DEVIATION|0.09||0.1063|TWO_SIDED|95.0|-0.06|0.01|||t-test, 2 sided|The sample for this paired t-test was 31 participants.|Mean difference is the change in scores from baseline to End of A.|Pairwise t-test for data from prosthesis users at baseline and completers at End of A (i.e. participants with JTHFT: Feeding data at both time points).||0.01|-0.06|0.1063
72377178|NCT01551420|144263020|SUPERIORITY||Mean Difference (Net)|-0.03|STANDARD_DEVIATION|0.12||0.2474|TWO_SIDED|95.0|-0.06|0.01|||t-test, 2 sided|The sample for this paired t-test was 31 participants.|Mean difference is the change in scores from baseline to End of A.|Pairwise t-test for data from prosthesis users at baseline and completers at End of A (i.e. participants with JTHFT: Light Cans data at both time points).||0.01|-0.06|0.2474
72377179|NCT01551420|144263020|SUPERIORITY||Mean Difference (Net)|-0.04|STANDARD_DEVIATION|0.14||0.1604|TWO_SIDED|95.0|-0.09|0.02|||t-test, 2 sided|The sample for this paired t-test was 31 participants.|Mean difference is the change in scores from baseline to End of A.|Pairwise t-test for data from prosthesis users at baseline and completers at End of A (i.e. participants with JTHFT: Heavy Cans data at both time points).||0.02|-0.09|0.1604
72377180|NCT01551420|144263020|SUPERIORITY||Slope|-0.06|STANDARD_ERROR_OF_MEAN|0.07||0.4208|TWO_SIDED|95.0|-0.12|0.09|||Regression, Linear|The sample for this analysis was 24 participants with TR or TH amputation level who completed data collection for JTHFT at End of Part B.|Effect of EMG-PR (compared to IMU group)|Linear regression of scores from JTHFT: Writing measure at 9-12 weeks (End of B), comparing groups by control type, and controlling for amputation level (transhumeral or transradial). Persons with shoulder level devices are excluded from this analysis.||0.09|-0.12|0.4208
72377181|NCT01551420|144263020|SUPERIORITY||Slope|-0.04|STANDARD_ERROR_OF_MEAN|0.03||0.1959|TWO_SIDED|95.0|-0.09|0.02|||Regression, Linear|The sample for this analysis was 23 participants with TR or TH amputation level who completed data collection for JTHFT at End of Part B.|Effect of EMG-PR (compared to IMU group)|Linear regression of scores from JTHFT: Page Turning measure at 9-12 weeks (End of B), comparing groups by control type, and controlling for amputation level (transhumeral or transradial). Persons with shoulder level devices are excluded from this analysis.||0.02|-0.09|0.1959
72377182|NCT01551420|144263020|SUPERIORITY|Linear regression of scores from JTHFT: Lifting Small Items measure at 9-12 weeks (End of B), comparing groups by control type, and controlling for amputation level (transhumeral or transradial). Persons with shoulder level devices are excluded from this analysis.|Slope|-0.03|STANDARD_ERROR_OF_MEAN|0.03||0.3328|TWO_SIDED|95.0|-0.09|0.03|||Regression, Linear|The sample for this analysis was 23 participants with TR or TH amputation level who completed data collection for JTHFT at End of Part B.|Effect of EMG-PR (compared to IMU group)|||0.03|-0.09|0.3328
72377183|NCT01551420|144263020|SUPERIORITY||Slope|0.01|STANDARD_ERROR_OF_MEAN|0.03||0.6585|TWO_SIDED|95.0|-0.05|0.08|||Regression, Linear|The sample for this analysis was 23 participants with TR or TH amputation level who completed data collection for JTHFT at End of Part B.|Effect of EMG-PR (compared to IMU group)|Linear regression of scores from JTHFT: Checkers measure at 9-12 weeks (End of B), comparing groups by control type, and controlling for amputation level (transhumeral or transradial). Persons with shoulder level devices are excluded from this analysis.||0.08|-0.05|0.6585
72618409|NCT01292473|144767760|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Refer to the Type-I error control plan.|Stratified Wilcoxon|Stratification variables included in the analysis were presence of angioedema at baseline (yes vs no) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis is that there is no difference between the placebo and omalizumab 300 mg.||||<0.0001
72377184|NCT01551420|144263020|SUPERIORITY|Linear regression of scores from JTHFT: Feeding measure at 9-12 weeks (End of B), comparing groups by control type, and controlling for amputation level (transhumeral or transradial). Persons with shoulder level devices are excluded from this analysis.|Slope|-0.06|STANDARD_ERROR_OF_MEAN|0.03||0.0552|TWO_SIDED|95.0|-0.12|0.0|||Regression, Linear|The sample for this analysis was 23 participants with TR or TH amputation level who completed data collection for JTHFT at End of Part B.|Effect of EMG-PR (compared to IMU group)|||0.00|-0.12|0.0552
72377185|NCT01551420|144263020|SUPERIORITY||Slope|-0.13|STANDARD_ERROR_OF_MEAN|0.06||0.0319|TWO_SIDED|95.0|-0.25|-0.01|||Regression, Linear|The sample for this analysis was 23 participants with TR or TH amputation level who completed data collection for JTHFT at End of Part B.|Effect of EMG-PR (compared to IMU group)|Linear regression of scores from JTHFT: Light Cans measure at 9-12 weeks (End of B), comparing groups by control type, and controlling for amputation level (transhumeral or transradial). Persons with shoulder level devices are excluded from this analysis.||-0.01|-0.25|0.0319
72377186|NCT01551420|144263020|SUPERIORITY||Slope|-0.14|STANDARD_ERROR_OF_MEAN|0.05||0.0073|TWO_SIDED|95.0|-0.24|-0.04|||Regression, Linear|The sample for this analysis was 23 participants with TR or TH amputation level who completed data collection for JTHFT at End of Part B.|Effect of EMG-PR (compared to IMU group)|Linear regression of scores from JTHFT: Heavy Cans measure at 9-12 weeks (End of B), comparing groups by control type, and controlling for amputation level (transhumeral or transradial). Persons with shoulder level devices are excluded from this analysis.||-0.04|-0.24|0.0073
72377187|NCT01551420|144263021|SUPERIORITY||Mean Difference (Net)|-0.04|STANDARD_DEVIATION|0.52||0.6529|TWO_SIDED|95.0|-0.24|0.15|||t-test, 2 sided|The sample for this paired t-test was 30 participants.|Mean difference is the change in scores from baseline to End of A.|Pairwise t-test for data from prosthesis users at baseline and completers at End of A (i.e. participants with UNB: Spontaneity data at both time points).||0.15|-0.24|0.6529
72377188|NCT01551420|144263021|SUPERIORITY||Mean Difference (Net)|-0.02|STANDARD_DEVIATION|0.64||0.849|TWO_SIDED|95.0|-0.26|0.22|||t-test, 2 sided|The sample for this paired t-test was 30 participants.|Mean difference is the change in scores from baseline to End of A.|Pairwise t-test for data from prosthesis users at baseline and completers at End of A (i.e. participants with UNB: Skill data at both time points).||0.22|-0.26|0.8490
72377189|NCT01551420|144263021|SUPERIORITY||Slope|0.13|STANDARD_ERROR_OF_MEAN|0.17||0.4589|TWO_SIDED|95.0|-0.22|0.48|||Regression, Linear|The sample for this analysis was 23 participants with TR or TH amputation level who completed data collection for UNB: Spontaneity at End of Part B.|Effect of EMG-PR (compared to IMU group)|Linear regression of scores from UNB: Spontaneity measure at 9-12 weeks (End of B), comparing groups by control type, and controlling for amputation level (transhumeral or transradial). Persons with shoulder level devices are excluded from this analysis.||0.48|-0.22|0.4589
72377190|NCT01551420|144263021|SUPERIORITY||Slope|0.07|STANDARD_ERROR_OF_MEAN|0.18||0.711|TWO_SIDED|95.0|-0.31|0.44|||Regression, Linear|The sample for this analysis was 23 participants with TR or TH amputation level who completed data collection for UNB: Skill at End of Part B.|Effect of EMG-PR (compared to IMU group)|Linear regression of scores from UNB: Skill measure at 9-12 weeks (End of B), comparing groups by control type, and controlling for amputation level (transhumeral or transradial). Persons with shoulder level devices are excluded from this analysis.||0.44|-0.31|0.7110
72377191|NCT01551420|144263022|SUPERIORITY||Mean Difference (Net)|253.6|STANDARD_DEVIATION|325.2|<|0.0001|TWO_SIDED|95.0|146.7|360.5|||t-test, 2 sided|The sample for this paired t-test was 38 participants.||Pairwise t-test for data for participants at baseline and completers at End of A (i.e participants with T-MAP data at both time points).|Mean difference is the change in scores from Baseline to End of A.|360.5|146.7|<0.0001
72377192|NCT01551420|144263022|SUPERIORITY||Slope|-183.1|STANDARD_ERROR_OF_MEAN|186.9||0.3397|TWO_SIDED|95.0|-574.3|208.2|||Regression, Linear|The sample for this analysis was 22 participants with TR or TH amputation level who completed data collection for T-MAP at End of Part B.|Effect of EMG-PR (compared to IMU group)|Linear regression of scores from T-MAP measure at 9-12 weeks (End of B), comparing groups by control type, and controlling for amputation level (transhumeral or transradial). Persons with shoulder level devices are excluded from this analysis.||208.2|-574.3|0.3397
72377193|NCT01551420|144263023|SUPERIORITY||Mean Difference (Net)|4.3|STANDARD_DEVIATION|10.01||0.0465|TWO_SIDED|95.0|0.07|8.53|||t-test, 2 sided|The sample for this paired t-test was 24 participants.|Mean difference is the change in scores from Baseline to End of A.|Pairwise t-test for data from prosthesis users at baseline and completers at End of A (i.e. participants with UEFS data at both time points).||8.53|0.07|0.0465
72377194|NCT01551420|144263023|SUPERIORITY||Slope|-2.39|STANDARD_ERROR_OF_MEAN|2.46||0.345|TWO_SIDED|95.0|-7.6|2.82|||Regression, Linear|The sample for this analysis was 19participants with TR or TH amputation level who completed data collection for UEFS at End of Part B.|Effect of EMG-PR (compared to IMU group)|Linear regression of scores from UEFS measure at 9-12 weeks (End of B), comparing groups by control type, and controlling for amputation level (transhumeral or transradial). Persons with shoulder level devices are excluded from this analysis.||2.82|-7.60|0.3450
72377195|NCT01551420|144263024|SUPERIORITY||Mean Difference (Net)|0.47|STANDARD_DEVIATION|7.54||0.6881|TWO_SIDED|95.0|-1.86|2.79|||t-test, 2 sided|The sample for this paired t-test was 43 participants.|Mean difference is the change in scores from Baseline to End of A.|Pairwise t-test for data for participants at baseline and completers at End of A (i.e participants with CRIS: Extent of Limitations data at both time points).||2.79|-1.86|0.6881
72377196|NCT01551420|144263024|SUPERIORITY||Mean Difference (Net)|-0.72|STANDARD_DEVIATION|13.95||0.7363|TWO_SIDED|95.0|-5.01|3.67|||t-test, 2 sided|The sample for this paired t-test was 43 participants.|Mean difference is the change in scores from Baseline to End of A.|Pairwise t-test for data from prosthesis users at baseline and completers at End of A (i.e. participants with CRIS: Perceived Limitations data at both time points).||3.67|-5.01|0.7363
72377197|NCT01551420|144263024|SUPERIORITY||Mean Difference (Net)|-1.49|STANDARD_DEVIATION|8.12||0.2361|TWO_SIDED|95.0|-3.99|1.01|||t-test, 2 sided|The sample for this paired t-test was 43 participants.|Mean difference is the change in scores from Baseline to End of A.|Pairwise t-test for data from prosthesis users at baseline and completers at End of A (i.e. participants with CRIS: Satisfaction data at both time points).||1.01|-3.99|0.2361
72618410|NCT00337194|144767774|SUPERIORITY_OR_OTHER|||||||0.06|TWO_SIDED||||||Chi-squared|||||||0.06
72618411|NCT00337194|144767775|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Fisher Exact|||||||1.0
72618412|NCT01623752|144767800|OTHER|||||||0.278|||||||Paired t-test|||P-value was calculated using Paired t-test for the change in normalized progression.||||0.278
72377198|NCT01551420|144263024|SUPERIORITY||Slope|-7.07|STANDARD_ERROR_OF_MEAN|4.02||0.0932|TWO_SIDED|95.0|-15.43|1.29|||Regression, Linear|The sample for this analysis was 24 participants with TR or TH amputation level who completed data collection for CRIS-CAT at End of Part B.|Effect of EMG-PR (compared to IMU group)|Linear regression of scores from CRIS-CAT: Extent of Limitations measure at 9-12 weeks (End of B), comparing groups by control type, and controlling for amputation level (transhumeral or transradial). Persons with shoulder level devices are excluded from this analysis.||1.29|-15.43|0.0932
72377199|NCT01551420|144263024|SUPERIORITY||Mean Difference (Final Values)|-10.5|STANDARD_ERROR_OF_MEAN|6.0||0.0951|TWO_SIDED|95.0|-22.9|1.99|||Regression, Linear|The sample for this analysis was 24 participants with TR or TH amputation level who completed data collection for CRIS-CAT at End of Part B.|Effect of EMG-PR (compared to IMU group)|Linear regression of scores from CRIS-CAT: Perceived Limitations measure at 9-12 weeks (End of B), comparing groups by control type, and controlling for amputation level (transhumeral or transradial). Persons with shoulder level devices are excluded from this analysis.||1.99|-22.9|0.0951
72377200|NCT01551420|144263024|SUPERIORITY||Slope|-4.91|STANDARD_ERROR_OF_MEAN|4.01||0.2346|TWO_SIDED|95.0|-13.3|3.43|||Regression, Linear|The sample for this analysis was 24 participants with TR or TH amputation level who completed data collection for CRIS-CAT at End of Part B.|Effect of EMG-PR (compared to IMU group)|Linear regression of scores from CRIS-CAT: Satisfaction measure at 9-12 weeks (End of B), comparing groups by control type, and controlling for amputation level (transhumeral or transradial). Persons with shoulder level devices are excluded from this analysis.||3.43|-13.3|0.2346
72377201|NCT03039621|144263037|SUPERIORITY|||||||0.026||||||a priori threshold for statistical significance equals 0.05|Wilcoxon (Mann-Whitney)|||||||0.026
72377202|NCT03039621|144263038|SUPERIORITY|||||||0.031|||||||Wilcoxon (Mann-Whitney)|||||||0.031
72377203|NCT03039621|144263039|SUPERIORITY|||||||0.022|||||||Wilcoxon (Mann-Whitney)|||||||0.022
72377204|NCT03039621|144263040|SUPERIORITY|||||||0.024|||||||Wilcoxon (Mann-Whitney)|||||||0.024
72377205|NCT03039621|144263041|SUPERIORITY|||||||0.0201||||||"The p-value associated with treatment factor of total severity index of the disease from Day 2 to Day 3, 4, 5 and 6 endpoint between Ergoferon and Placebo treatment groups. Model includes treatment, visit and treatment\*visit interaction."|Mixed Models Analysis|||||||0.0201
72618413|NCT01623752|144767800|OTHER|||||||0.222|||||||Paired t-test|||P-value was calculated using Paired t-test for the change in normalized progression.||||0.222
72618414|NCT01623752|144767801|OTHER|||||||0.251|||||||Paired t-test|||P-value was calculated using Paired t-test for the change in normalized progression.||||0.251
72377206|NCT03039621|144263042|SUPERIORITY|||||||0.046|||||||Wilcoxon (Mann-Whitney)|||||||0.046
72377207|NCT03039621|144263043|SUPERIORITY|||||||0.0025|||||||Cochran-Mantel-Haenszel|||||||0.0025
72377208|NCT03039621|144263043|OTHER|Test for assessing the homogeneity of the odds ratio in several 2 × 2 contingency tables.||||||0.22|||||||Breslow-Day test|||||||0.22
72377209|NCT03039621|144263044|SUPERIORITY|||||||0.0037||||||"The p-value associated with treatment factor of total severity index of the disease from Day 1 to Day 2, 3 and 4 endpoint between Ergoferon and Placebo treatment groups. Model includes treatment, visit and treatment\*visit interaction."|Mixed Models Analysis|||||||0.0037
72433594|NCT00991276|144380368|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-14.47|STANDARD_ERROR_OF_MEAN|6.0||0.0174|TWO_SIDED|95.0|-26.35|-2.59||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||Stage N2 sleep: P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||-2.59|-26.35|0.0174
72377210|NCT03039621|144263045|SUPERIORITY|||||||0.0001|||||||Fisher Exact|||||||0.0001
72377211|NCT01879579|144263050|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Chi-squared|||||||<0.0001
72377212|NCT01879579|144263051|SUPERIORITY_OR_OTHER|||||||0.007|TWO_SIDED||||||Interval-censoring survival analysis|||||||0.007
72377213|NCT01879579|144263052|SUPERIORITY_OR_OTHER|||||||0.99|TWO_SIDED||||||Wilcoxon rank-sum test|||||||0.99
72377214|NCT01879579|144263053|SUPERIORITY_OR_OTHER|||||||0.78|TWO_SIDED||||||Wilcoxon rank-sum test|||||||0.78
72377215|NCT01879579|144263054|SUPERIORITY_OR_OTHER|||||||0.04|TWO_SIDED||||||Wilcoxon rank-sum test|||||||0.04
72377216|NCT01879579|144263055|SUPERIORITY_OR_OTHER|||||||0.13|TWO_SIDED||||||Wilcoxon rank-sum test|||||||0.13
72377217|NCT01879579|144263060|SUPERIORITY_OR_OTHER|||||||0.008|TWO_SIDED||||||Generalized estimating equation modeling|||||||0.008
72377218|NCT01879579|144263061|SUPERIORITY_OR_OTHER|||||||0.003|TWO_SIDED||||||Wilcoxon rank-sum test|||||||0.003
72377219|NCT01949337|144263072|SUPERIORITY||Hazard Ratio (HR)|0.93||||0.33|TWO_SIDED|95.0|0.8|1.08|||Log Rank|||||1.08|0.80|0.33
72377220|NCT02519855|144263079|NON_INFERIORITY_OR_EQUIVALENCE|A lower bound of the 95% CI on the fold difference (GMT ratio \[Concomitant / Nonconcomitant\] at 4 weeks postvaccination) \>0.67 implied that the difference is statistically significantly noninferior to the prespecified clinically relevant decrease of 1.5-fold. A p-value ≤0.025 also supported a conclusion of noninferiority.|GMT Ratio at 4 weeks postvaccination|0.87|||<|0.001|TWO_SIDED|95.0|0.8|0.95|||Longitudinal regression model|GMT ratio, 95% CI and p-value were based on a longitudinal regression model adjusting for prevaccination titers and age.||||0.95|0.80|<0.001
72377221|NCT02519855|144263080|SUPERIORITY_OR_OTHER||GMFR from Baseline|1.9|||<|0.001|TWO_SIDED|95.0|1.76|2.05||A lower bound of the 95% CI on the GMFR \> 1.4 indicated that the Concomitant Group induces an acceptable VZV antibody response. A p-value ≤0.025 also supported this conclusion.|Longitudinal regression||Estimated GMFR, 95% CI and p-value were based on a longitudinal regression model adjusting for age.|||2.05|1.76|<0.001
72618415|NCT01623752|144767801|OTHER|||||||0.218|||||||Paired t-test|||P-value was calculated using Paired t-test for the change in normalized progression.||||0.218
72618416|NCT01623752|144767804|OTHER|||||||0.675|||||||Regression, Linear|||||||0.675
72618417|NCT01623752|144767804|OTHER|||||||0.357|||||||Regression, Linear|||||||0.357
72618418|NCT01623752|144767805|OTHER|||||||0.106|||||||ANOVA|||Statistical analysis (P value) composite for all categories.||||0.106
72618419|NCT01623752|144767805|OTHER|||||||0.181|||||||ANOVA|||Statistical analysis (P value) composite for all categories.||||0.181
72618420|NCT01623752|144767806|OTHER|||||||0.015|||||||ANOVA|||Statistical analysis (P value) composite for all categories.||||0.015
72377222|NCT02519855|144263081|NON_INFERIORITY_OR_EQUIVALENCE|A lower bound of the 95% CI on the fold difference (GMT ratio \[Concomitant / Nonconcomitant\] at 4 weeks postvaccination) \>0.67 implied that the difference is statistically significantly noninferior to the prespecified clinically relevant decrease of 1.5-fold. A p-value ≤0.025 also supported the conclusion of noninferiority.|GMT Ratio at 4 weeks postvaccination|1.02|||<|0.001|TWO_SIDED|95.0|0.88|1.18|||Longitudinal regression|GMT ratio, 95% CI and p-value were based on a longitudinal regression model adjusting for prevaccination titers and age.||||1.18|0.88|<0.001
72377223|NCT02519855|144263082|NON_INFERIORITY_OR_EQUIVALENCE|A lower bound of the 95% CI on the fold difference (GMT ratio \[Concomitant / Nonconcomitant\] at 4 weeks postvaccination) \>0.67 implied that the difference is statistically significantly noninferior to the prespecified clinically relevant decrease of 1.5-fold. A p-value ≤0.025 also supported the conclusion of noninferiority.|GMT Ratio at 4 weeks postvaccination|1.1|||<|0.001|TWO_SIDED|95.0|0.94|1.29|||Longitudinal regression|GMT ratio, 95% CI and p-value were based on a longitudinal regression model adjusting for prevaccination titers and age.||||1.29|0.94|<0.001
72377224|NCT02519855|144263083|NON_INFERIORITY_OR_EQUIVALENCE|A lower bound of the 95% CI on the fold difference (GMT ratio \[Concomitant / Nonconcomitant\] at 4 weeks postvaccination) \>0.67 implied that the difference is statistically significantly noninferior to the prespecified clinically relevant decrease of 1.5-fold. A p-value ≤0.025 also supported the conclusion of noninferiority.|GMT Ratio at 4 weeks postvaccination|1.0|||<|0.001|TWO_SIDED|95.0|0.88|1.14|||Longitudinal regression|GMT ratio, 95% CI and p-value were based on a longitudinal regression model adjusting for prevaccination titers and age.||||1.14|0.88|<0.001
72377225|NCT02519855|144263084|NON_INFERIORITY_OR_EQUIVALENCE|A lower bound of the 95% CI on the fold difference (GMT ratio \[Concomitant / Nonconcomitant\] at 4 weeks postvaccination) \>0.67 implied that the difference is statistically significantly noninferior to the prespecified clinically relevant decrease of 1.5-fold. A p-value ≤0.025 also supported the conclusion of noninferiority.|GMT Ratio at 4 weeks postvaccination|0.99|||<|0.001|TWO_SIDED|95.0|0.87|1.13|||Longitudinal regression|GMT ratio, 95% CI and p-value were based on a longitudinal regression model adjusting for prevaccination titers and age.||||1.13|0.87|<0.001
72377226|NCT02415842|144263235|EQUIVALENCE|Adjusted GMC ratios of anti-H1 HA stalk ELISA antibody concentration between groups (H1N1\_AS over H1N1\_NAS) at Day 21. Adjusted GMC = GMC adjusted for baseline concentration.|Adjusted GMC ratio|1.12|||||TWO_SIDED|95.0|0.73|1.72|||ANCOVA|ANCOVA model on logarithm10 transformation of concentration, with vaccine group as fixed effect and anti- H1 stalk ELISA result at Day 0 as covariates||||1.72|0.73|
72377227|NCT02415842|144263235|EQUIVALENCE|Adjusted GMC ratios of anti-H1 HA stalk ELISA antibody concentration between groups (H1N1\_AS over H1N1\_NAS) at Day 42. Adjusted GMC = GMC adjusted for baseline concentration.|Adjusted GMC ratio|1.23|||||TWO_SIDED|95.0|0.83|1.81|||ANCOVA|ANCOVA model on logarithm10 transformation of concentration, with vaccine group as fixed effect and anti- H1 stalk ELISA result at Day 0 as covariates||||1.81|0.83|
72377228|NCT02415842|144263235|EQUIVALENCE|Adjusted GMC ratios of anti-H1 HA stalk ELISA antibody concentration between groups (H1N1\_AS over H1N1\_NAS) at Day 182. Adjusted GMC = GMC adjusted for baseline concentration.|Adjusted GMC ratio|0.88|||||TWO_SIDED|95.0|0.63|1.24|||ANCOVA|ANCOVA model on logarithm10 transformation of concentration, with vaccine group as fixed effect and anti- H1 stalk ELISA result at Day 0 as covariates||||1.24|0.63|
72377229|NCT02415842|144263236|EQUIVALENCE|Adjusted GMC ratios of anti-H1 HA stalk ELISA antibody concentration between groups (H5N1\_AS over H5N1\_NAS) at Day 21 . Adjusted GMC = GMC adjusted for baseline concentration.|Adjusted GMC ratio|1.66|||||TWO_SIDED|95.0|1.12|2.47|||ANCOVA|ANCOVA model on logarithm10 transformation of concentration, with vaccine group as fixed effect and anti- H1 stalk ELISA result at Day 0 as covariates||||2.47|1.12|
72377230|NCT02415842|144263236|EQUIVALENCE|Adjusted GMC ratios of anti-H1 HA stalk ELISA antibody concentration between groups (H5N1\_AS over H5N1\_NAS) at Day 42. Adjusted GMC = GMC adjusted for baseline concentration.|Adjusted GMC ratio|2.16|||||TWO_SIDED|95.0|1.54|3.03|||ANCOVA|ANCOVA model on logarithm10 transformation of concentration, with vaccine group as fixed effect and anti- H1 stalk ELISA result at Day 0 as covariates||||3.03|1.54|
72377231|NCT02415842|144263236|EQUIVALENCE|Adjusted GMC ratios of anti-H1 HA stalk ELISA antibody concentration between groups (H5N1\_AS over H5N1\_NAS) at Day 182. Adjusted GMC = GMC adjusted for baseline concentration.|Adjusted GMC ratio|1.95|||||TWO_SIDED|95.0|1.49|2.54|||ANCOVA|ANCOVA model on logarithm10 transformation of concentration, with vaccine group as fixed effect and anti- H1 stalk ELISA result at Day 0 as covariates||||2.54|1.49|
72377232|NCT02415842|144263236|EQUIVALENCE|Adjusted GMC ratios of anti-H1 HA stalk ELISA antibody concentration between groups (H5N1\_AS over H5N1\_NAS) at Day 385 . Adjusted GMC = GMC adjusted for baseline concentration.|Adjusted GMC ratio|1.63|||||TWO_SIDED|95.0|1.32|2.01|||ANCOVA|ANCOVA model on logarithm10 transformation of concentration, with vaccine group as fixed effect and anti- H1 stalk ELISA result at Day 0 as covariates||||2.01|1.32|
72377233|NCT02415842|144263237|EQUIVALENCE|Adjusted GMC ratios of anti-H1 HA stalk ELISA antibody concentration between groups (H9N2\_AS over H9N2\_NAS) at Day 21. Adjusted GMC = GMC adjusted for baseline concentration.|Adjusted GMC ratio|1.39|||||TWO_SIDED|95.0|1.14|1.69|||ANCOVA|ANCOVA model on logarithm10 transformation of concentration, with vaccine group as fixed effect and anti- H1 stalk ELISA result at Day 0 as covariates||||1.69|1.14|
72556204|NCT03930732|144643539|SUPERIORITY||LS Mean Difference|-3.363||||0.0017|TWO_SIDED|95.0|-5.459|-1.266||Threshold for significance at 0.049 level.|MMRM model|||Derived from MMRM model with the change from baseline in SGRQ total score up to Week 52 as response variables, and treatment group, region (pooled country), ICS dose, smoking status at screening, treatment-by-visit interaction, baseline SGRQ total score, and SGRQ baseline-by-visit interaction as covariates. Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-1.266|-5.459|0.0017
72556205|NCT03930732|144643540|SUPERIORITY||Odds Ratio (OR)|1.439||||0.0089|TWO_SIDED|95.0|1.096|1.89||Threshold for significance at 0.049 level.|Regression, Logistic|||Derived from logistic regression model which includes treatment group, region (pooled country), ICS dose, smoking status at screening, and baseline SGRQ total score as covariates. Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||1.890|1.096|0.0089
72377234|NCT02415842|144263237|EQUIVALENCE|Adjusted GMC ratios of anti-H1 HA stalk ELISA antibody concentration between groups (H9N2\_AS over H9N2\_NAS) at Day 42. Adjusted GMC = GMC adjusted for baseline concentration.|Adjusted GMC ratio|1.49|||||TWO_SIDED|95.0|1.28|1.73|||ANCOVA|ANCOVA model on logarithm10 transformation of concentration, with vaccine group as fixed effect and anti- H1 stalk ELISA result at Day 0 as covariates||||1.73|1.28|
72377235|NCT02415842|144263237|EQUIVALENCE|Adjusted GMC ratios of anti-H1 HA stalk ELISA antibody concentration between groups (H9N2\_AS over H9N2\_NAS) at Day 182. Adjusted GMC = GMC adjusted for baseline concentration.|Adjusted GMC ratio|1.2|||||TWO_SIDED|95.0|1.0|1.44|||ANCOVA|ANCOVA model on logarithm10 transformation of concentration, with vaccine group as fixed effect and anti- H1 stalk ELISA result at Day 0 as covariates||||1.44|1.00|
72377236|NCT02415842|144263238|EQUIVALENCE|Difference between groups (H1N1\_AS minus H1N1\_NAS) in percentage of subjects with at least 4-fold increase of anti-H1 stalk ELISA at Day 21.|Difference in percentage of subjects|10.79|||||TWO_SIDED|95.0|-16.5|36.83|||Asymptotic standardized 95% CI|||||36.83|-16.50|
72377237|NCT02415842|144263238|EQUIVALENCE|Difference between groups (H1N1\_AS minus H1N1\_NAS) in percentage of subjects with at least 4-fold increase of anti-H1 stalk ELISA at Day 42.|Difference in percentage of subjects|12.0|||||TWO_SIDED|95.0|-14.45|36.98|||Asymptotic standardized 95% CI|||||36.98|-14.45|
72377238|NCT02415842|144263238|EQUIVALENCE|Difference between groups (H1N1\_AS minus H1N1\_NAS) in percentage of subjects with at least 4-fold increase of anti-H1 stalk ELISA at Day 182.|Difference in percentage of subjects|-6.07|||||TWO_SIDED|95.0|-30.56|18.65|||Asymptotic standardized 95% CI|||||18.65|-30.56|
72377239|NCT02415842|144263239|EQUIVALENCE|Difference between groups (H5N1\_AS minus H5N1\_NAS) in percentage of subjects with at least 4-fold increase of anti-H1 stalk ELISA at Day 21.|Difference in percentage of subjects|27.08|||||TWO_SIDED|95.0|5.96|47.01|||Asymptotic standardized 95% CI|||||47.01|5.96|
72377240|NCT02415842|144263239|EQUIVALENCE|Difference between groups (H5N1\_AS minus H5N1\_NAS) in percentage of subjects with at least 4-fold increase of anti-H1 stalk ELISA at Day 42.|Difference in percentage of subjects|36.65|||||TWO_SIDED|95.0|11.41|57.53|||Asymptotic standardized 95% CI|||||57.53|11.41|
72377241|NCT02415842|144263239|EQUIVALENCE|Difference between groups (H5N1\_AS minus H5N1\_NAS) in percentage of subjects with at least 4-fold increase of anti-H1 stalk ELISA at Day 182.|Difference in percentage of subjects|6.39|||||TWO_SIDED|95.0|-11.91|24.71|||Asymptotic standardized 95% CI|||||24.71|-11.91|
72377242|NCT02415842|144263239|EQUIVALENCE|Difference between groups (H5N1\_AS minus H5N1\_NAS) in percentage of subjects with at least 4-fold increase of anti-H1 stalk ELISA at Day 365.|Difference in percentage of subjects|6.9|||||TWO_SIDED|95.0|-6.19|22.15|||Asymptotic standardized 95% CI|||||22.15|-6.19|
72377243|NCT02415842|144263240|EQUIVALENCE|Difference between groups (H9N2\_AS minus H9N2\_NAS) in percentage of subjects with at least 4-fold increase of anti-H1 stalk ELISA at Day 21.|Difference in percentage of subjects|3.33|||||TWO_SIDED|95.0|-13.06|20.24|||Asymptotic standardized 95% CI|||||20.24|-13.06|
72377244|NCT02415842|144263240|EQUIVALENCE|Difference between groups (H9N2\_AS minus H9N2\_NAS) in percentage of subjects with at least 4-fold increase of anti-H1 stalk ELISA at Day 42.|Difference in percentage of subjects|16.67|||||TWO_SIDED|95.0|0.35|34.76|||Asymptotic standardized 95% CI|||||34.76|0.35|
72377245|NCT02415842|144263240|EQUIVALENCE|Difference between groups (H9N2\_AS minus H9N2\_NAS) in percentage of subjects with at least 4-fold increase of anti-H1 stalk ELISA at Day 182.|Difference in percentage of subjects|0.24|||||TWO_SIDED|95.0|-13.76|15.0|||Asymptotic standardized 95% CI|||||15.00|-13.76|
72377246|NCT03739242|144263271|SUPERIORITY||Least Square Mean difference|-39.16|||<|0.0001|TWO_SIDED|95.0|-48.57|-29.75|||ANCOVA|||||-29.75|-48.57|<0.0001
72377247|NCT03739242|144263272|SUPERIORITY||Least Square Mean difference|-41.24||||0.0001|TWO_SIDED|95.0|-51.73|-30.74|||ANCOVA|||||-30.74|-51.73|0.0001
72377248|NCT03739242|144263273|SUPERIORITY||Least Square Mean difference|0.09||||0.951|TWO_SIDED|95.0|-2.87|3.05|||ANCOVA|||||3.05|-2.87|0.9510
72377249|NCT03739242|144263274|SUPERIORITY||Least Square Mean difference|-41.7|||<|0.0001|TWO_SIDED|95.0|-51.58|-31.82|||ANCOVA|||||-31.82|-51.58|<0.0001
72377250|NCT03739242|144263275|SUPERIORITY||Least Square Mean difference|-7.0||||0.1924|TWO_SIDED|95.0|-17.59|3.59|||ANCOVA|||||3.59|-17.59|0.1924
72377251|NCT03739242|144263276|SUPERIORITY||Least Square Mean difference|-17.26|||<|0.0001|TWO_SIDED|95.0|-23.54|-10.98|||ANCOVA|||||-10.98|-23.54|<0.0001
72377252|NCT03739242|144263277|SUPERIORITY||Least Square Mean difference|-0.91|||<|0.0001|TWO_SIDED|95.0|-1.19|-0.62|||ANCOVA|||||-0.62|-1.19|<0.0001
72377253|NCT03739242|144263278|SUPERIORITY||Least Square Mean difference|-0.82|||<|0.0001|TWO_SIDED|95.0|-1.05|-0.59|||ANCOVA|||||-0.59|-1.05|<0.0001
72377254|NCT03739242|144263279|SUPERIORITY||Least Square Mean difference|-3.47||||0.4535|TWO_SIDED|95.0|-12.64|5.7|||ANCOVA|||||5.7|-12.64|0.4535
72377255|NCT03739242|144263280|SUPERIORITY||Least Square Mean difference|0.74||||0.5594|TWO_SIDED|95.0|-1.76|3.24|||ANCOVA|||||3.24|-1.76|0.5594
72377256|NCT03739242|144263281|SUPERIORITY||Least Square Mean difference|-0.07||||0.9266|TWO_SIDED|95.0|-1.63|1.48|||ANCOVA|||||1.48|-1.63|0.9266
72377257|NCT03739242|144263282|SUPERIORITY||Least Square Mean difference|6.02||||0.2654|TWO_SIDED|95.0|-4.66|16.69|||ANCOVA|||||16.69|-4.66|0.2654
72377258|NCT03739242|144263283|SUPERIORITY||Least Square Mean difference|-5.95||||0.2595|TWO_SIDED|95.0|-16.37|4.47|||ANCOVA|||||4.47|-16.37|0.2595
72377259|NCT03739242|144263284|SUPERIORITY||Least Square Mean difference|0.003||||0.8476|TWO_SIDED|95.0|-0.039|0.032|||ANCOVA|||||0.032|-0.039|0.8476
72377260|NCT03739242|144263285|SUPERIORITY||Least Square Mean difference|-0.21||||0.1499|TWO_SIDED|95.0|-0.49|0.08|||ANCOVA|||||0.08|-0.49|0.1499
72377261|NCT03739242|144263286|SUPERIORITY||Least Square Mean difference|1.71||||0.7224|TWO_SIDED|95.0|-7.83|11.25|||ANCOVA|||||11.25|-7.83|0.7224
72377262|NCT01029405|144263343|SUPERIORITY_OR_OTHER||||||<|0.001|||||||2-sided sign test|||||||<0.001
72377263|NCT01895361|144263360|OTHER||Hodges-Lehmann median absolute diff.|-1.01|||=|0.01|TWO_SIDED|95.0|-2.0|0.0|||Stratified Wilcoxon Rank Sum Test|with HU therapy (yes, no) and categorized crisis history (2 to 4, 5 to 10) as recorded in the IXRS system as the strata.||||0.00|-2.00|= 0.010
72377264|NCT01895361|144263360|OTHER||Hodges-Lehmann median absolute diff.|-0.69|||=|0.18|TWO_SIDED|95.0|-1.84|0.02|||Stratified Wilcoxon Rank Sum Test|with HU therapy (yes, no) and categorized crises history (2 to 4, 5 to 10) as recorded in the IXRS system as the strata.||||0.02|-1.84|= 0.180
72377265|NCT01895361|144263361|OTHER||Change vs placebo (%)|-45.3|||||ONE_SIDED|||||||||||||
72377266|NCT01895361|144263361|OTHER||Change vs placebo (%)|-32.6|||||ONE_SIDED|||||||||||||
72377267|NCT01895361|144263362|OTHER||Hodges-Lehmann median absolute diff.|0.0|||=|0.45|TWO_SIDED|95.0|-4.36|0.0|||Stratified Wilcoxon Rank Sum Test|with HU therapy (yes, no) and categorized crises history (2 to 4, 5 to 10) as recorded in the IXRS system as the strata.||||0.00|-4.36|= 0.450
72618421|NCT01623752|144767806|OTHER|||||||0.969|||||||ANOVA|||Statistical analysis (P value) composite for all categories.||||0.969
72377268|NCT01895361|144263362|OTHER||Hodges-Lehmann median absolute diff.|0.0|||=|0.837|TWO_SIDED|95.0|-3.9|2.61|||Stratified Wilcoxon Rank Sum Test|with HU therapy (yes, no) and categorized crises history (2 to 4, 5 to 10) as recorded in the IXRS system as the strata.||||2.61|-3.90|= 0.837
72377269|NCT01895361|144263363|OTHER||Hazard Ratio (HR)|0.495|||=|0.001|TWO_SIDED|95.0|0.331|0.741|||Log Rank||Calculated based on Cox regression analysis with HU therapy (yes, no), categorized crises history (2 to 4, 5 to 10), and treatment as covariates|||0.741|0.331|= 0.001
72377270|NCT01895361|144263363|OTHER||Hazard Ratio (HR)|0.752|||=|0.136|TWO_SIDED|95.0|0.515|1.097|||Log Rank||Calculated based on Cox regression analysis with HU therapy (yes, no), categorized crises history (2 to 4, 5 to 10), and treatment as covariates|||1.097|0.515|= 0.136
72377271|NCT01895361|144263364|OTHER||Hazard Ratio (HR)|0.534|||=|0.022|TWO_SIDED|95.0|0.329|0.866|||Log Rank||Calculated based on Cox regression analysis with HU therapy (yes, no), categorized crises history (2 to 4, 5 to 10), and treatment as covariates|||0.866|0.329|= 0.022
72377272|NCT01895361|144263364|OTHER||Hazard Ratio (HR)|0.693|||=|0.1|TWO_SIDED|95.0|0.44|1.092|||Log Rank||Calculated based on Cox regression analysis with HU therapy (yes, no), categorized crises history (2 to 4, 5 to 10), and treatment as covariates|||1.092|0.440|= 0.100
72377273|NCT01895361|144263365|OTHER||Hodges-Lehmann median absolute diff.|-1.0|||=|0.015|TWO_SIDED|95.0|-1.98|0.0|||Stratified Wilcoxon Rank Sum Test|with HU therapy (yes, no) and categorized crises history (2 to 4, 5 to 10) as recorded in the IXRS system as the strata||||0.00|-1.98|= 0.015
72377274|NCT01895361|144263365|OTHER||Hodges-Lehmann median absolute diff.|-0.87|||=|0.12|TWO_SIDED|95.0|-1.77|0.0|||Stratified Wilcoxon Rank Sum Test|with HU therapy (yes, no) and categorized crises history (2 to 4, 5 to 10) as recorded in the IXRS system as the strata||||0.00|-1.77|= 0.120
72377275|NCT01895361|144263366|OTHER||Hodges-Lehmann median absolute diff.|0.0|||=|0.78|TWO_SIDED|95.0|0.0|0.0|||Stratified Wilcoxon Rank Sum test|with HU therapy (yes, no) and categorized crises history (2 to 4, 5 to 10) as recorded in the IXRS system as the strata||||0.00|0.00|= 0.780
72377276|NCT01895361|144263366|OTHER||Hodges-Lehmann median absolute diff.|0.0|||=|0.868|TWO_SIDED|95.0|0.0|0.0|||Stratified Wilcoxon Rank Sum test|with HU therapy (yes, no) and categorized crises history (2 to 4, 5 to 10) as recorded in the IXRS system as the strata.||||0.00|0.00|= 0.868
72377277|NCT02692651|144263384|SUPERIORITY|||||||0.195|||||||Chi-squared, Corrected|||||||0.195
72377278|NCT02692651|144263385|SUPERIORITY|||||||0.99|||||||Chi-squared, Corrected|||||||.99
72377279|NCT02692651|144263386|SUPERIORITY|||||||0.999|||||||Chi-squared, Corrected|||||||.999
72377280|NCT01860846|144263395|SUPERIORITY_OR_OTHER||||||=|0.004||||||Baseline vs. 12 months|Wilcoxon signed-ranked test|||The null hypothesis was set as no difference.||||=0.004
72377281|NCT01860846|144263396|SUPERIORITY_OR_OTHER||||||=|0.022||||||Baseline vs. 12 Months|Wilcoxon signed-ranked test|||The null hypothesis was set as no difference.||||= 0.022
72377282|NCT01860846|144263397|SUPERIORITY_OR_OTHER||||||=|0.006||||||Baseline vs. 12 Months|Wilcoxon signed-ranked test|||The null hypothesis was set as no difference.||||= 0.006
72377283|NCT01860846|144263398|SUPERIORITY_OR_OTHER||||||<|0.001||||||Baseline vs. 12 Months|Wilcoxon signed-ranked test|||The null hypothesis was set as no difference.||||< 0.001
72377284|NCT01860846|144263399|SUPERIORITY_OR_OTHER||||||<|0.001||||||Baseline vs. 12 Months|Wilcoxon signed-ranked test|||Physical Functioning Scores: the null hypothesis was set as no difference.||||< 0.001
72377285|NCT01860846|144263399|SUPERIORITY_OR_OTHER||||||<|0.001||||||Baseline vs. 12 Months|Wilcoxon signed-ranked test|||Role-Physical Scores: the null hypothesis was set as no difference.||||< 0.001
72377286|NCT01860846|144263399|SUPERIORITY_OR_OTHER||||||=|0.001||||||Baseline vs. 12 Months|Wilcoxon signed-ranked test|||Role-Emotional Scores: the null hypothesis was set as no difference.||||= 0.001
72377287|NCT01860846|144263399|SUPERIORITY_OR_OTHER||||||=|0.019||||||Baseline vs. 12 Months|Wilcoxon signed-ranked test|||Vitality Scores: the null hypothesis was set as no difference.||||= 0.019
72377288|NCT01860846|144263399|SUPERIORITY_OR_OTHER||||||=|0.017||||||Baseline vs. 12 Months|Wilcoxon signed-ranked test|||Mental Health Scores: the null hypothesis was set as no difference.||||= 0.017
72377289|NCT01860846|144263399|SUPERIORITY_OR_OTHER||||||=|0.007||||||Baseline vs. 12 Months|Wilcoxon signed-ranked test|||Social Functioning Scores: the null hypothesis was set as no difference.||||= 0.007
72377290|NCT01860846|144263399|SUPERIORITY_OR_OTHER||||||<|0.001||||||Baseline vs. 12 Months|Wilcoxon signed-ranked test|||Bodily Pain Scores: the null hypothesis was set as no difference.||||< 0.001
72377291|NCT01860846|144263399|SUPERIORITY_OR_OTHER||||||=|0.005||||||Baseline vs. 12 Months|Wilcoxon signed-ranked test|||General Health Scores: the null hypothesis was set as no difference.||||= 0.005
72377292|NCT01860846|144263400|SUPERIORITY_OR_OTHER||||||<|0.001||||||Baseline vs. 12 Months|Wilcoxon signed-ranked test|||Bowel-related Symptoms Scores: The null hypothesis was set as no difference.||||< 0.001
72377293|NCT01860846|144263400|SUPERIORITY_OR_OTHER||||||<|0.001||||||Baseline vs. 12 Months|Wilcoxon signed-ranked test|||Systemic Symptoms Scores:The null hypothesis was set as no difference.||||< 0.001
72377294|NCT01860846|144263400|SUPERIORITY_OR_OTHER||||||<|0.001||||||Baseline vs. 12 Months|Wilcoxon signed-ranked test|||Emotional Function Scores: the null hypothesis was set as no difference.||||< 0.001
72377295|NCT01860846|144263400|SUPERIORITY_OR_OTHER||||||<|0.001||||||Baseline vs. 12 Months|Wilcoxon signed-ranked test|||Social Function Scores: The null hypothesis was set as no difference.||||< 0.001
72377296|NCT02239120|144263404|SUPERIORITY||Hazard Ratio (HR)|0.85||||0.1028|TWO_SIDED|95.0|0.69|1.03|||Regression, Cox|Covariates in model are age(\<or\>= 75years), creatinine clearance \< or \>= 50mL/min and stroke or transient ischaemic attack(TIA) prior to index stroke.||||1.03|0.69|0.1028
72377297|NCT02239120|144263405|SUPERIORITY||Hazard Ratio (HR)|1.36||||0.1076|TWO_SIDED|95.0|0.94|1.97|||Regression, Cox|Covariates in model are age(\<or\>= 75years), creatinine clearance \< or \>= 50mL/min and stroke or transient ischaemic attack(TIA) prior to index stroke.||||1.97|0.94|0.1076
72377298|NCT02239120|144263406|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.0892|TWO_SIDED|95.0|0.68|1.03|||Regression, Cox|Covariates in model are age(\<or\>= 75years), creatinine clearance \< or \>= 50mL/min and stroke or transient ischaemic attack(TIA) prior to index stroke.||||1.03|0.68|0.0892
72377299|NCT02239120|144263407|SUPERIORITY||Hazard Ratio (HR)|0.88||||0.1911|TWO_SIDED|95.0|0.73|1.06|||Regression, Cox|Covariates in model are age(\<or\>= 75years), creatinine clearance \< or \>= 50mL/min and stroke or transient ischaemic attack(TIA) prior to index stroke.||||1.06|0.73|0.1911
72618422|NCT01623752|144767807|OTHER|||||||0.489|||||||ANOVA|||Statistical analysis (P value) composite for all categories.||||0.489
72377300|NCT02239120|144263408|SUPERIORITY||Hazard Ratio (HR)|0.59||||0.0354|TWO_SIDED|95.0|0.36|0.96|||Regression, Cox|Covariates in model are age(\<or\>= 75years), creatinine clearance \< or \>= 50mL/min and stroke or transient ischaemic attack(TIA) prior to index stroke.||||0.96|0.36|0.0354
72377301|NCT02239120|144263409|SUPERIORITY||Hazard Ratio (HR)|0.96||||0.8074|TWO_SIDED|95.0|0.66|1.38|||Regression, Cox|Covariates in model are age(\<or\>= 75years), creatinine clearance \< or \>= 50mL/min and stroke or transient ischaemic attack(TIA) prior to index stroke.||||1.38|0.66|0.8074
72377302|NCT02239120|144263410|SUPERIORITY||Hazard Ratio (HR)|1.03||||0.9064|TWO_SIDED|95.0|0.58|1.83|||Regression, Cox|Covariates in model are age(\<or\>= 75years), creatinine clearance \< or \>= 50mL/min and stroke or transient ischaemic attack(TIA) prior to index stroke.||||1.83|0.58|0.9064
72377303|NCT02239120|144263412|SUPERIORITY||Hazard Ratio (HR)|0.82||||0.4352|TWO_SIDED|95.0|0.49|1.36|||Regression, Cox|Covariates in model are age(\<or\>= 75years), creatinine clearance \< or \>= 50mL/min and stroke or transient ischaemic attack(TIA) prior to index stroke.||||1.36|0.49|0.4352
72377304|NCT02239120|144263413|SUPERIORITY||Hazard Ratio (HR)|1.28||||0.0003|TWO_SIDED|95.0|1.12|1.47|||Regression, Cox|Covariates in model are age(\<or\>= 75years), creatinine clearance \< or \>= 50mL/min and stroke or transient ischaemic attack(TIA) prior to index stroke.||||1.47|1.12|0.0003
72377305|NCT05072470|144263421|SUPERIORITY|When p-value is adjusted for multiple comparisons, the level of statistical significance must be \</= to .01666667 (.05/3)|||||<|0.01|||||||t-test, 2 sided|||Speech intelligibility will be better with hearing aids plus Roger device, than with hearing aids alone when tested using standardized speech test at 0 dB SNR||||<0.01
72377306|NCT05072470|144263421|SUPERIORITY|||||||0.031||||||When p value is adjusted for multiple comparisons, the level of statistical significance must be \</= to .01666667 (.05/3)|t-test, 2 sided|||Speech intelligibility will be better with hearing aids plus Roger device, than with hearing aids alone when tested using standardized speech test at -5 dB SNR||||.031
72377307|NCT05072470|144263421|SUPERIORITY|||||||0.046||||||When p-values are adjusted for multiple comparisons, the level of statistical significance must be \</= .01666667 (.05/3)|t-test, 2 sided|||Speech intelligibility will be equal or better with hearing aids plus Roger device than with hearing aids alone when tested using standardized speech test at +5 dB SNR.||||.046
72377308|NCT04456153|144263431|SUPERIORITY|||||||0.17|||||||GLMM|||||||0.170
72433595|NCT00991276|144380368|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|37.17|STANDARD_ERROR_OF_MEAN|5.96|<|0.0001|TWO_SIDED|95.0|25.38|48.96||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||Stage N2 sleep: P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||48.96|25.38|<0.0001
72377309|NCT04456153|144263432|SUPERIORITY|||||||0.051|||||||GLMM|||||||0.051
72377310|NCT04456153|144263435|SUPERIORITY|||||||0.68|||||||Chi-squared|||||||0.68
72377311|NCT04456153|144263436|SUPERIORITY|||||||0.76|||||||trapezoidal method|||||||0.76
72377312|NCT02387476|144263443|NON_INFERIORITY|This analysis was planned to assume a non-inferiority (NI) margin of 5 units and a 1-sided alpha level of 2.5%. A 2-sided 95% confidence interval (CI) was also planned to be provided around the difference between treatments, where non-inferiority would also be demonstrated if the upper bound of the 95% CI is less than or equal to the NI margin of 5 units. In this scenario, the 2-sided 95% CI equates to testing the 1-sided non-inferiority hypothesis.|Mean Difference (Final Values)|0.6|STANDARD_DEVIATION|1.13|<|0.001|TWO_SIDED|95.0|-1.7|2.9||The p-value to test non-inferiority of FRESCA Mask compared with CPAP Mask (FRESCA-CPAP\<5 units) assumes a 1-sided test using a level of significance of 2.5% and NI margin of 5 units.|t-test, 1 sided||The mean AHI is rounded to a single decimal point in the text of the report (3.0 and 2.4, respectively), in order to be consistent with standard reporting of AHI.|This analysis was planned to assume a non-inferiority (NI) margin of 5 units and a 1-sided alpha level of 2.5%. A 2-sided 95% confidence interval (CI) was also planned to be provided around the difference between treatments, where non-inferiority would also be demonstrated if the upper bound of the 95% CI is less than or equal to the NI margin of 5 units. In this scenario, the 2-sided 95% CI equates to testing the 1-sided non-inferiority hypothesis.||2.9|-1.7|<0.001
72377313|NCT02387476|144263444|NON_INFERIORITY|This analysis was planned to assume a non-inferiority (NI) margin of 5 units and a 1-sided alpha level of 2.5%. A 2-sided 95% confidence interval (CI) was also planned to be provided around the difference between treatments, where non-inferiority would also be demonstrated if the upper bound of the 95% CI is less than or equal to the NI margin of 5 units. In this scenario, the 2-sided 95% CI equates to testing the 1-sided non-inferiority hypothesis.|Mean Difference (Final Values)|0.3|STANDARD_DEVIATION|0.36|<|0.001|TWO_SIDED|95.0|-0.4|1.0||The p-value to test non-inferiority of FRESCA Mask compared with CPAP Mask (FRESCA-CPAP\<5 units) assumes a 1-sided test using a level of significance of 2.5% and NI margin of 5 units.|t-test, 1 sided||The mean ODI values are rounded to a single decimal point value in the text of the table (1.4 and 1.1, respectively) to ensure consistency with ODI reporting standards.|This analysis was planned to assume a non-inferiority (NI) margin of 5 units and a 1-sided alpha level of 2.5%. A 2-sided 95% confidence interval (CI) was also planned to be provided around the difference between treatments, where non-inferiority would also be demonstrated if the upper bound of the 95% CI is less than or equal to the NI margin of 5 units. In this scenario, the 2-sided 95% CI equates to testing the 1-sided non-inferiority hypothesis.||1.0|-0.4|<0.001
72377314|NCT02081248|144263522|SUPERIORITY|||||||0.37||||||Testing was performed at a significance level of 0.05|t-test, 2 sided|Two-sample t-test comparing mean QuIC-A scores performed using 150 degrees of freedom||The null hypothesis is that there is no difference in comprehension of the parent clinical trial, as measured by the QuIC-A, between participants reviewing a standard consent and easy-to-read informed consent (ETRIC) forms. Mean QuIC-A scores were compared between arms, which should be approximately equal under the null hypothesis.||||0.37
72377315|NCT02081248|144263523|SUPERIORITY|||||||0.39||||||Testing performed at a significance level of 0.05|Wilcoxon (Mann-Whitney)|||The null hypothesis is that there is no difference in participants' perception of their comprehension of the parent clinical trial, as measured by the QuIC-B, between participants reviewing a standard consent and easy-to-read informed consent (ETRIC) forms. Median QuIC-B scores were compared between arms, which should be approximately equal under the null hypothesis.||||0.39
72377316|NCT02081248|144263524|SUPERIORITY|||||||0.17||||||Testing was performed at a significance level of 0.05|Wilcoxon (Mann-Whitney)|||The null hypothesis is that there is no difference in participants' comprehension of the parent clinical trial, as measured by the DICCT, between participants reviewing a standard consent and easy-to-read informed consent (ETRIC) forms. Median DICCT scores were compared between arms, which should be approximately equal under the null hypothesis.||||0.17
72377317|NCT02081248|144263527|SUPERIORITY|||||||0.21||||||Testing was performed at a significance level of 0.05|Wilcoxon (Mann-Whitney)|||The null hypothesis is that there is no difference in participants' state anxiety, as measured by the STAI, between participants reviewing a standard consent and easy-to-read informed consent (ETRIC) forms. Median state anxiety subscores of the STAI were compared between arms, which should be equal under the null hypothesis.||||0.21
72377318|NCT02081248|144263527|SUPERIORITY|||||||0.25||||||Testing was performed at a significance level of 0.05|Wilcoxon (Mann-Whitney)|||The null hypothesis is that there is no difference in participants' trait anxiety, as measured by the STAI, between participants reviewing a standard consent and easy-to-read informed consent (ETRIC) forms. Median trait anxiety subscores of the STAI were compared between arms, which should be equal under the null hypothesis.||||0.25
72377319|NCT02081248|144263528|SUPERIORITY|||||||0.8||||||Testing was performed at a significance level of 0.05|Wilcoxon (Mann-Whitney)|||The null hypothesis is that there is no difference in satisfaction with the consent process, as measured by a study-specific questionnaire, between participants reviewing a standard consent and easy-to-read informed consent (ETRIC) forms. Median participant satisfaction scores were compared between arms, which should be equal under the null hypothesis.||||0.80
72377320|NCT02081248|144263529|SUPERIORITY|||||||0.73||||||Testing was performed at a significance level of 0.05|Wilcoxon (Mann-Whitney)|||The null hypothesis is that there is no difference in the time required to find the main goal of the study between participants reviewing a standard consent and easy-to-read informed consent (ETRIC) forms. Median time required to find the main goal of the study was compared between arms, which should be equal under the null hypothesis.||||0.73
72377321|NCT02081248|144263529|SUPERIORITY|||||||0.26||||||Testing was performed at a significance level of 0.05|Wilcoxon (Mann-Whitney)|||The null hypothesis is that there is no difference in the time required to find who to contact for questions between participants reviewing a standard consent and easy-to-read informed consent (ETRIC) forms. Median time required to find who to contact for questions was compared between arms, which should be equal under the null hypothesis.||||0.26
72377322|NCT02081248|144263529|SUPERIORITY|||||||0.74||||||Testing was performed at a significance level of 0.05|Wilcoxon (Mann-Whitney)|||The null hypothesis is that there is no difference in the time required to find the risks and benefits section between participants reviewing a standard consent and easy-to-read informed consent (ETRIC) forms. Median time required to find the risks and benefits section was compared between arms, which should be equal under the null hypothesis.||||0.74
72377323|NCT02081248|144263529|SUPERIORITY|||||||0.56||||||Testing was performed at a significance level of 0.05|Wilcoxon (Mann-Whitney)|||The null hypothesis is that there is no difference in the time required to find how to leave the study between participants reviewing a standard consent and easy-to-read informed consent (ETRIC) forms. Median time required to find how to leave the study was compared between arms, which should be equal under the null hypothesis.||||0.56
72377324|NCT02081248|144263529|SUPERIORITY|||||||0.79||||||Testing was performed at a significance level of 0.05|Wilcoxon (Mann-Whitney)|||The null hypothesis is that there is no difference in the time required to find study procedures between participants reviewing a standard consent and easy-to-read informed consent (ETRIC) forms. Median time required to find study procedures was compared between arms, which should be equal under the null hypothesis.||||0.79
72377325|NCT02081248|144263530|SUPERIORITY|||||||1||||||Testing was performed at a significance level of 0.05|Fisher Exact|||The null hypothesis is that there is no difference in the consent rates to BMT CTN 0901 between participants reviewing a standard consent and easy-to-read informed consent (ETRIC) forms. Consent rates to BMT CTN 0901 were compared between arms in participants considering enrollment, which should be equal under the null hypothesis.||||1.00
72377326|NCT02081248|144263530|SUPERIORITY|||||||0.77||||||Testing was performed at a significance level of 0.05|Fisher Exact|||The null hypothesis is that there is no difference in the consent rates to BMT CTN 1101 between participants reviewing a standard consent and easy-to-read informed consent (ETRIC) forms. Consent rates to BMT CTN 1101 were compared between arms in participants considering enrollment, which should be approximately equal under the null hypothesis.||||0.77
72377327|NCT02081248|144263530|SUPERIORITY|||||||0.69||||||Testing was performed at a significance level of 0.05|Fisher Exact|||The null hypothesis is that there is no difference in the consent rates to BMT CTN 1203 between participants reviewing a standard consent and easy-to-read informed consent (ETRIC) forms. Consent rates to BMT CTN 1203 were compared between arms in participants considering enrollment, which should be approximately equal under the null hypothesis.||||0.69
72377328|NCT02081248|144263530|SUPERIORITY|||||||0.26||||||Testing was performed at a significance level of 0.05|Fisher Exact|||The null hypothesis is that there is no difference in the consent rates to BMT CTN 1301 between participants reviewing a standard consent and easy-to-read informed consent (ETRIC) forms. Consent rates to BMT CTN 1501 were compared between arms in participants considering enrollment, which should be approximately equal under the null hypothesis.||||0.26
72377329|NCT04268823|144263607|SUPERIORITY||Least Squares mean|-0.203|STANDARD_ERROR_OF_MEAN|0.1938||0.298|TWO_SIDED|80.0|-0.524|0.119|||Mixed effects Model for Repeated Measure||Treatment difference (QBW251-placebo)|||0.119|-0.524|0.298
72377330|NCT04268823|144263608|SUPERIORITY||Least Squares mean|-0.2|STANDARD_ERROR_OF_MEAN|0.44||0.651|TWO_SIDED|80.0|-0.9|0.5|||Mixed effects Model for Repeated Measure||Treatment difference (QBW251-placebo)|||0.5|-0.9|0.651
72377331|NCT04268823|144263609|SUPERIORITY||Least Squares mean|-1.39|STANDARD_ERROR_OF_MEAN|1.29||0.288|TWO_SIDED|80.0|-3.55|0.78|||Mixed effects Model for Repeated Measure||Treatment difference (QBW251-placebo)|||0.78|-3.55|0.288
72377332|NCT04268823|144263610|SUPERIORITY||Least Squares mean|4.2|STANDARD_ERROR_OF_MEAN|4.336||0.338|TWO_SIDED|80.0|-3.09|11.48|||Mixed effects Model for Repeated Measure||Treatment difference (QBW251-placebo)|||11.48|-3.09|0.338
72377333|NCT04268823|144263611|SUPERIORITY||Least Squares mean|-0.82|STANDARD_ERROR_OF_MEAN|3.147||0.795|TWO_SIDED|80.0|-6.05|4.42|||Mixed effects Model for Repeated Measure||Treatment difference (QBW251-placebo)|Total score||4.42|-6.05|0.795
72618423|NCT01623752|144767807|OTHER|||||||0.386|||||||ANOVA|||Statistical analysis (P value) composite for all categories.||||0.386
72377334|NCT04268823|144263611|SUPERIORITY||Least Squares mean|5.75|STANDARD_ERROR_OF_MEAN|4.155||0.17|TWO_SIDED|80.0|-1.16|12.66|||Mixed effects Model for Repeated Measure||Treatment difference (QBW251-placebo)|Symptoms score||12.66|-1.16|0.170
72377335|NCT04268823|144263611|SUPERIORITY||Least Squares mean|-0.61|STANDARD_ERROR_OF_MEAN|3.259||0.851|TWO_SIDED|80.0|-6.02|4.8|||Mixed effects Model for Repeated Measure||Treatment difference (QBW251-placebo)|Activity score||4.80|-6.02|0.851
72377336|NCT04268823|144263611|SUPERIORITY||Least Squares mean|-2.07|STANDARD_ERROR_OF_MEAN|4.035||0.61|TWO_SIDED|80.0|-8.78|4.65|||Mixed effects Model for Repeated Measure||Treatment difference (QBW251-placebo)|Impact score||4.65|-8.78|0.610
72377337|NCT04268823|144263612|SUPERIORITY||Least Squares mean|0.25|STANDARD_ERROR_OF_MEAN|4.557||0.956|TWO_SIDED|80.0|-7.3|7.8|||Mixed effects Model for Repeated Measure||Treatment difference (QBW251-placebo)|Cough symptom score||7.80|-7.30|0.956
72377338|NCT04268823|144263612|SUPERIORITY||Least Squares mean|4.22|STANDARD_ERROR_OF_MEAN|4.671||0.369|TWO_SIDED|80.0|-3.55|11.99|||Mixed effects Model for Repeated Measure||Treatment difference (QBW251-placebo)|Sputum symptom score||11.99|-3.55|0.369
72377339|NCT04268823|144263612|SUPERIORITY||Least Squares mean|2.03|STANDARD_ERROR_OF_MEAN|4.001||0.613|TWO_SIDED|80.0|-4.61|8.68|||Mixed effects Model for Repeated Measure||Treatment difference (QBW251-placebo)|Cough impact score||8.68|-4.61|0.613
72377340|NCT04268823|144263612|SUPERIORITY||Least Squares mean|0.94|STANDARD_ERROR_OF_MEAN|4.518||0.835|TWO_SIDED|80.0|-6.58|8.47|||Mixed effects Model for Repeated Measure||Treatment difference (QBW251-placebo)|Sputum impact score||8.47|-6.58|0.835
72377341|NCT04268823|144263614|SUPERIORITY||Least Squares Mean|0.0|STANDARD_ERROR_OF_MEAN|0.04||0.335|TWO_SIDED|80.0|0.0|0.1|||Mixed effects Model for Repeated Measure||Treatment difference (QBW251-placebo)|||0.1|0.0|0.335
72377342|NCT04268823|144263615|SUPERIORITY||Least Squares mean|0.0|STANDARD_ERROR_OF_MEAN|0.07||0.645|TWO_SIDED|80.0|-0.1|0.1|||Mixed effects Model for Repeated Measure||Treatment difference (QBW251-placebo)|||0.1|-0.1|0.645
72377343|NCT04268823|144263616|SUPERIORITY||Least Squares mean|2.1|STANDARD_ERROR_OF_MEAN|0.8||0.01|TWO_SIDED|80.0|0.8|3.4|||Mixed effects Model for Repeated Measure||Treatment difference (QBW251-placebo)|||3.4|0.8|0.010
72377344|NCT03386253|144263645|SUPERIORITY|||||||0.77||||||Group x time p value|ANOVA|||||||0.77
72377345|NCT01198158|144263662|SUPERIORITY|||||||0.739|||||||Log Rank|OS was analyzed based on an intent-to-treat approach using the stratified log-rank statistic adjusting on the stratification factors.||||||0.739
72377346|NCT01198158|144263663|SUPERIORITY|||||||0.832|||||||Log Rank|PFS was analyzed based on an intent-to-treat approach using the stratified log-rank statistic adjusting on the stratification factors||||||0.832
72377347|NCT01205581|144263670|SUPERIORITY_OR_OTHER|||||||0.78|||||||Fisher Exact|||||||0.78
72377348|NCT01205581|144263673|SUPERIORITY_OR_OTHER|||||||0.48|||||||Fisher Exact|||||||0.48
72377349|NCT01205581|144263674|SUPERIORITY_OR_OTHER|||||||0.51|||||||Fisher Exact|||||||0.51
72377350|NCT01205581|144263675|SUPERIORITY_OR_OTHER|||||||0.29|||||||Fisher Exact|||||||0.29
72377351|NCT01205581|144263676|SUPERIORITY_OR_OTHER|||||||0.43|||||||Fisher Exact|||||||0.43
72504983|NCT01462292|144541163|SUPERIORITY_OR_OTHER||Mean Difference (Net)|167.39||||0.921|TWO_SIDED|95.0|-3208.98|3543.77||No adjustment for multiplicity was made, so p-values should not be used to make conclusions with regards to statistical significance|Mixed Model Repeated Measures|Model included terms for treatment, visit, treatment by visit, center grouping, baseline and baseline by visit||Treatment difference: Placebo Vs GSK2402968 6 mg, Week 48||3543.77|-3208.98|0.921
72377352|NCT01205581|144263677|SUPERIORITY_OR_OTHER|||||||0.11|||||||Fisher Exact|||||||0.11
72377353|NCT01063712|144263692|SUPERIORITY_OR_OTHER||||||<|0.01|||||||percentage|||It is not a analysis of two groups. Only one group of patients was analyzed.||||<0.01
72377354|NCT01063712|144263693|SUPERIORITY_OR_OTHER||||||<|0.01|||||||percentage|The analysis was made on the basis of the percentage of patients with completely regressed dilation.||It is a one arm clinical study. No comparison between groups was made.||||<0.01
72377355|NCT05033002|144263708|SUPERIORITY||Slope|-0.41|||<|0.0001|TWO_SIDED|||||The p-value is for the t-test of the coefficient of linear (TimeXGroup) trends.|Mixed Models Analysis||The estimated value is for the slope of linear (TimeXGroup) trends. Controlled for significant covariates.|||||<.0001
72377356|NCT05033002|144263708|SUPERIORITY||Slope|0.002|||<|0.0001|TWO_SIDED|||||The p-value is for the t-test of the coefficient of quadratic (TimeXTimeXGroup) trends.|Mixed Models Analysis||The estimated value is for the slope of quadratic (TimeXTimeXGroup) trends. Controlled for significant covariates.|||||<.0001
72377357|NCT05033002|144263709|SUPERIORITY||Slope|0.06||||0.002|TWO_SIDED|||||The p-value is for the t-test of the coefficient of linear (TimeXGroup) trends.|Mixed Models Analysis||The estimated value is for the slope of linear (TimeXGroup) trends. Controlled for significant covariates.|||||.002
72377358|NCT05033002|144263709|SUPERIORITY||Slope|-0.0003||||0.01|TWO_SIDED|||||The p-value is for the t-test of the coefficient of quadratic (TimeXTimeXGroup) trends.|Mixed Models Analysis||The estimated value is for the slope of quadratic (TimeXTimeXGroup) trends. Controlled for significant covariates.|||||.010
72377359|NCT05033002|144263710|SUPERIORITY||Slope|0.05||||0.001|TWO_SIDED|||||The p-value is for the t-test of the coefficient of linear (TimeXGroup) trends.|Mixed Models Analysis||The estimated value is for the slope of linear (TimeXGroup) trends. Controlled for significant covariates.|||||.001
72377360|NCT05033002|144263710|SUPERIORITY||Slope|-0.0002||||0.032|TWO_SIDED|||||The p-value is for the t-test of the coefficient of quadratic (TimeXTimeXGroup) trends.|Mixed Models Analysis||The estimated value is for the slope of quadratic (TimeXTimeXGroup) trends. Controlled for significant covariates.|||||.032
72377361|NCT05033002|144263711|SUPERIORITY||Mean Difference (Final Values)|0.34||||0.506|TWO_SIDED||||||t-test, 2 sided|||||||0.506
72377362|NCT05033002|144263712|SUPERIORITY|||||||0.441||||||The p-value is for the t-test of the coefficient of linear (TimeXGroup) trends.|Mixed Models Analysis|The estimated value is for the slope of linear (TimeXGroup) trends. Controlled for significant covariates.||||||.441
72377363|NCT05033002|144263712|SUPERIORITY||Slope|0.0002||||0.734|TWO_SIDED|||||The p-value is for the t-test of the coefficient of quadratic (TimeXTimeXGroup) trends.|Mixed Models Analysis||The estimated value is for the slope of quadratic (TimeXTimeXGroup) trends. Controlled for significant covariates.|||||.734
72377364|NCT00246571|144263728|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.203||||0.8885|TWO_SIDED|95.0|0.8889|1.628||One-sided log-rank test stratified for the number of prior chemotherapy regiments (1 versus more than 1), which is from the interactive voice response system (IVRS).|Log Rank|||For core radiology laboratory assessment||1.6280|0.8889|0.8885
72377365|NCT00246571|144263728|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.1598||||0.8472|TWO_SIDED|95.0|0.8703|1.5457||One-sided log-rank test stratified for the number of prior chemotherapy regiments (1 versus more than 1), which is from IVRS.|Log Rank|||For investigator's assessment||1.5457|0.8703|0.8472
72377366|NCT00246571|144263729|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.38||||0.9624|TWO_SIDED|95.0|0.06|1.71||The stratified analysis was from Cochran-Mantel-Haenszel (CMH) test stratified by randomization stratification factor, the number of prior chemotherapy regimens (1 versus more than 1), which is from IVRS.|Cochran-Mantel-Haenszel|||Core radiology laboratory assessment||1.71|0.06|0.9624
72377367|NCT00246571|144263729|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.74||||0.814|TWO_SIDED|95.0|0.27|1.98||The stratified analysis was from Cochran-Mantel-Haenszel (CMH) test stratified by randomization stratification factor, the number of prior chemotherapy regimens (1 versus more than 1), which is from IVRS.|Cochran-Mantel-Haenszel|||Investigator's assessment||1.98|0.27|0.8140
72377368|NCT00246571|144263732|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.1599||||0.8394|TWO_SIDED|95.0|0.8648|1.5558||One-sided log rank test stratified for the number of prior chemotherapy regimens (1 versus more than 1), which is from IVRS.|Log Rank||Hazard ratio for sunitinib versus standard of care.|||1.5558|0.8648|0.8394
72377369|NCT04896229|144263748|SUPERIORITY||Slope|1.2|STANDARD_ERROR_OF_MEAN|0.52||0.022|TWO_SIDED||||||t-test, 2 sided|||The results show the condition x time interaction from the growth model, and the parameter estimate describes the relative change of the intervention condition to the treatment-as-usual condition, for a unit change in time.||||.022
72377370|NCT04896229|144263749|SUPERIORITY||Slope|0.09|STANDARD_ERROR_OF_MEAN|0.35||0.8|TWO_SIDED||||||t-test, 2 sided|||The results show the condition x time interaction from the growth model, and the parameter estimate describes the relative change of the intervention condition to the treatment-as-usual condition, for a unit change in time.||||.800
72377371|NCT04896229|144263750|SUPERIORITY||Slope|0.58|STANDARD_ERROR_OF_MEAN|0.49||0.235|TWO_SIDED||||||t-test, 2 sided|||The results show the condition x time interaction from the growth model, and the parameter estimate describes the relative change of the intervention condition to the treatment-as-usual condition, for a unit change in time.||||.235
72377372|NCT04896229|144263751|SUPERIORITY||Slope|0.29|STANDARD_ERROR_OF_MEAN|0.3||0.325|TWO_SIDED||||||t-test, 2 sided|||The results show the condition x time interaction from the growth model, and the parameter estimate describes the relative change of the intervention condition to the treatment-as-usual condition, for a unit change in time.||||.325
72377373|NCT04896229|144263752|SUPERIORITY||Slope|-0.02|STANDARD_ERROR_OF_MEAN|0.03||0.502|TWO_SIDED||||||t-test, 2 sided|||The results show the condition x time interaction from the growth model, and the parameter estimate describes the relative change of the intervention condition to the treatment-as-usual condition, for a unit change in time.||||.502
72377374|NCT04896229|144263753|SUPERIORITY||Slope|0.06|STANDARD_ERROR_OF_MEAN|0.02||0.005|TWO_SIDED||||||t-test, 2 sided|||The results show the condition x time interaction from the growth model, and the parameter estimate describes the relative change of the intervention condition to the treatment-as-usual condition, for a unit change in time.||||.005
72377375|NCT04896229|144263754|SUPERIORITY||Slope|-0.1|STANDARD_ERROR_OF_MEAN|0.03||0.712|TWO_SIDED||||||t-test, 2 sided|||The results show the condition x time interaction from the growth model, and the parameter estimate describes the relative change of the intervention condition to the treatment-as-usual condition, for a unit change in time.||||.712
72377376|NCT04896229|144263755|SUPERIORITY||Slope|0.03|STANDARD_ERROR_OF_MEAN|0.03||0.245|TWO_SIDED||||||t-test, 2 sided|||The results show the condition x time interaction from the growth model, and the parameter estimate describes the relative change of the intervention condition to the treatment-as-usual condition, for a unit change in time.||||.245
72377377|NCT04896229|144263756|SUPERIORITY||Slope|-0.03|STANDARD_ERROR_OF_MEAN|0.03||0.282|TWO_SIDED||||||t-test, 2 sided|||The results show the condition x time interaction from the growth model, and the parameter estimate describes the relative change of the intervention condition to the treatment-as-usual condition, for a unit change in time.||||.282
72377378|NCT04896229|144263757|SUPERIORITY||Slope|0.04|STANDARD_ERROR_OF_MEAN|0.03||0.289|TWO_SIDED||||||t-test, 2 sided|||The results show the condition x time interaction from the growth model, and the parameter estimate describes the relative change of the intervention condition to the treatment-as-usual condition, for a unit change in time.||||.289
72377379|NCT04896229|144263758|SUPERIORITY||Slope|-0.02|STANDARD_ERROR_OF_MEAN|0.02||0.296|TWO_SIDED||||||t-test, 2 sided|||The results show the condition x time interaction from the growth model, and the parameter estimate describes the relative change of the intervention condition to the treatment-as-usual condition, for a unit change in time.||||.296
72377380|NCT00159822|144263783|SUPERIORITY_OR_OTHER||Percent of subjects with success|31.7||||||95.0|18.08|48.09|||||Number of subjects with successful global outcomes were summarized and 95% two-sided confidence intervals based on the exact Clopper-Pearson method for the binomial distribution provided.|For sample size calculation, null hypothesis (p\<p0) is defined as response rate \<15% (ie, weak drug efficacy). Alternative hypothesis (p\>pA) defined as response rate \>30%. To reduce the chance of incorrectly rejecting the null hypothesis to 5% (α=5%) and incorrectly rejecting the alternate hypothesis to 20% (β=20%) it was calculated that a sample size of 48 subjects was required. Null hypothesis was rejected (assessing efficacy of study drug) if the number of eligible success was ≥ than n=12.||48.09|18.08|
72377381|NCT00159822|144263784|SUPERIORITY_OR_OTHER||Percent of subjects with success|33.3||||||95.0|18.6|51.0|||||Number of subjects with successful global outcomes were summarized and 95% two-sided confidence intervals based on the exact Clopper-Pearson method for the binomial distribution provided.|Month 3 success=yes||51.0|18.6|
72377382|NCT00159822|144263784|SUPERIORITY_OR_OTHER||Percent of subjects with success|43.9||||||95.0|28.5|60.3|||||Number of subjects with successful global outcomes were summarized and 95% two-sided confidence intervals based on the exact Clopper-Pearson method for the binomial distribution provided.|EOT success=yes||60.3|28.5|
72377383|NCT00159822|144263790|SUPERIORITY_OR_OTHER||Kaplan-Meier estimate overall survival|0.85||||||95.0|0.725|0.976|||||Global survival rate calculated using Kaplan-Meier estimate of overall survival.|||0.976|0.725|
72493933|NCT03178487|144516776|SUPERIORITY|To preserve the overall type I error rate at α=0.05 level, a step-down approach was used to test the primary and multiplicity-controlled key secondary endpoints. The testing began with the primary endpoint at α=0.05 and continued conditional on significance of higher-ranked endpoint.|Response Rate Difference|26.1|||<|0.001|TWO_SIDED|95.0|12.6|39.5|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusting for stratification factor of Screening hsCRP level.|Response Rate Difference = Upadacitinib - Placebo|||39.5|12.6|<0.001
72377384|NCT03702244|144263795|SUPERIORITY|Statistical testing for recurrent events was performed using the negative binomial methods for recurrent events.|Hazard Ratio (HR)|0.29|||<|0.001|TWO_SIDED|95.0|0.2|0.41|||Log Rank||Hazard ratio was adjusted for age, sex, and coronary artery disease equivalent (diabetes, history of peripheral artery disease or cerebrovascular disease), and intended first test strata (invasive or noninvasive).|Sample size and power calculations for this study are based on the hypothesis that the precision evaluation arm is superior to the usual care arm on the time-to-first event of the composite 3-component endpoint: all-cause death, non-fatal MI, or invasive cardiac catheterization without obstructive CAD over a 12-month of follow-up. Time to event analysis will use the date of the event, including the date of catheterization at which the absence of obstructive CAD is demonstrated.||0.41|0.20|<.001
72377385|NCT00713310|144263801|SUPERIORITY_OR_OTHER||High-Low Dose Difference Success Rates|-1.1||||0.924|TWO_SIDED|95.0|-22.7|20.5|||Cochran-Mantel-Haenszel|||A total of about 100 subjects were to be enrolled in the study with the expectation that about 80 subjects (40/dose level) would complete. Minimum of 9 subjects in 5-8 year old range were to be enrolled, 4-5 per dose level (high/low). A 2-sided α=0.05 Fisher's Exact test has an estimated power of P=0.50 with 40 subjects per dose level.||20.5|-22.7|0.9240
72377386|NCT00713310|144263802|SUPERIORITY_OR_OTHER||High-Low Dose Difference Success Rates|1.4||||0.8193|TWO_SIDED|95.0|-20.2|23.0|||Cochran-Mantel-Haenszel|||A total of about 100 subjects were to be enrolled in the study with the expectation that about 80 subjects (40/dose level) would complete. Minimum of 9 subjects in 5-8 year old range were to be enrolled, 4-5 per dose level (high/low). A 2-sided α=0.05 Fisher's Exact test has an estimated power of P=0.50 with 40 subjects per dose level.||23.0|-20.2|0.8193
72377387|NCT00329901|144263811|NON_INFERIORITY_OR_EQUIVALENCE|The immune response to Tdap + MenACWY-CRM was considered non-inferior to that of Tdap+saline if for all five antigens (diphtheria, tetanus, PT, FHA, PRN) the lower limit of the 95% CI of the difference \[(Tdap + MenACWY-CRM) minus(Tdap + saline)\] was greater than -10, at 1 month (Day 29) after vaccination|Vaccine Group difference|9.0|||||TWO_SIDED|95.0|5.0|14.0||||||Non-inferiority of anti-diphtheria immune response following concomitant administration of Tdap with MenACWY-CRM as compared to Tdap given with placebo saline||14|5|
72377388|NCT00329901|144263811|NON_INFERIORITY_OR_EQUIVALENCE|The immune response to Tdap + MenACWY-CRM was considered non-inferior to that of Tdap+saline if for all five antigens (diphtheria, tetanus, PT, FHA, PRN) the lower limit of the 95% CI of the difference \[(Tdap + MenACWY-CRM) minus(Tdap + saline)\] was greater than -10, at 1 month (Day 29) after vaccination|Vaccine Group Difference|1.0|||||TWO_SIDED|95.0|-1.0|2.0||||||Non-inferiority of anti-tetanus immune response following concomitant administration of Tdap with MenACWY-CRM compared to Tdap given concomitantly with saline placebo||2|-1|
72377389|NCT00329901|144263811|NON_INFERIORITY_OR_EQUIVALENCE|The immune response to Tdap + MenACWY-CRM was considered non-inferior to that of Tdap+saline if for all five antigens (diphtheria, tetanus, PT, FHA, PRN) the lower limit of the 95% CI of the difference \[(Tdap + MenACWY-CRM) minus (Tdap + saline)\] was greater than -10, at 1 month (Day 29) after vaccination|Vaccine Group difference|-5.0|||||TWO_SIDED|95.0|-12.0|1.0||||||Non-inferiority of anti-PT antigen immune response following concomitant administration of Tdap with MenACWY as compared to Tdap given concomitantly with saline placebo||1|-12|
72377390|NCT00329901|144263811|NON_INFERIORITY_OR_EQUIVALENCE|The immune response to Tdap + MenACWY-CRM was considered non-inferior to that of Tdap+saline if for all five antigens (diphtheria, tetanus, PT, FHA, PRN) the lower limit of the 95% CI of the difference \[(Tdap + MenACWY-CRM) minus (Tdap + saline)\] was greater than -10, at 1 month (Day 29) after vaccination|Vaccine Group Difference|-3.0|||||TWO_SIDED|95.0|-9.0|3.0||||||Non-inferiority of anti-FHA antigen immune response following concomitant administration of Tdap with MenACWY as compared to Tdap given concomitantly with saline placebo||3|-9|
72377391|NCT00329901|144263811|NON_INFERIORITY_OR_EQUIVALENCE|The immune response to Tdap + MenACWY-CRM was considered non-inferior to that of Tdap+saline if for all five antigens (diphtheria, tetanus, PT, FHA, PRN) the lower limit of the 95% CI of the difference \[(Tdap + MenACWY-CRM) minus (Tdap + saline)\] was greater than -10, at 1 month (Day 29) after vaccination|Vaccine Group Difference|-7.0|||||TWO_SIDED|95.0|-13.0|-2.0||||||Non-inferiority of anti-PRN antigen immune response following concomitant administration of Tdap with MenACWY as compared to Tdap given concomitantly with saline placebo||-2|-13|
72377392|NCT00992589|144263822|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-0.449||||0.168|TWO_SIDED|95.0|-1.087|0.19|||ANCOVA|||Analysis of Covariance with Treatment as fixed effect, Region and Age as stratification factors and Change from Open-label (OL) Baseline to OL Endpoint as covariate to test the hypothesis of no difference in change in daily average frequency of regurgitation from Double-blind (DB) Baseline to DB Endpoint between rabeprazole sodium total and placebo.||0.190|-1.087|0.168
72377393|NCT00992589|144263823|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|0.03||||0.44|TWO_SIDED|95.0|-0.047|0.108|||ANCOVA|||Analysis of Covariance with Treatment as fixed effect, Region and Age as stratification factors and Double-blind (DB) Baseline as covariate to test the hypothesis of no difference in change in Weight-for-Age Z-Score from DB Baseline to DB Endpoint between Rabeprazole Sodium Total and Placebo.||0.108|-0.047|0.440
72377394|NCT00992589|144263825|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|0.006||||0.984|TWO_SIDED|95.0|-0.619|0.632|||ANCOVA|||Analysis of Covariance with Treatment as fixed effect, Region and Age as stratification factors and Change from Open-label (OL) Baseline to OL Endpoint as covariate to test the hypothesis of no difference in change in weekly average I-GERQ-DD Regurgitation Subscale Score from Double-blind (DB) Baseline to DB Endpoint between rabeprazole sodium total and placebo.||0.632|-0.619|0.984
72377395|NCT00992589|144263826|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-0.182||||0.479|TWO_SIDED|95.0|-0.69|0.325|||ANCOVA|||Analysis of Covariance with Treatment as fixed effect, Region and Age as stratification factors and Change from Open-label (OL) Baseline to OL Endpoint as covariate to test the hypothesis of no difference in change in weekly average I-GERQ-DD Discomfort Subscale Score from Double-blind (DB) Baseline to DB Endpoint between rabeprazole sodium total and placebo.||0.325|-0.690|0.479
72377396|NCT00992589|144263827|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-0.192||||0.498|TWO_SIDED|95.0|-0.751|0.366|||ANCOVA|||Analysis of Covariance with Treatment as fixed effect, Region and Age as stratification factors and Change from Open-label (OL) Baseline to OL Endpoint as covariate to test the hypothesis of no difference in change in weekly average I-GERQ-DD Eating Behavior Subscale Score from Double-blind (DB) Baseline to DB Endpoint between rabeprazole sodium total and placebo.||0.366|-0.751|0.498
72618424|NCT01623752|144767808|OTHER|||||||0.364|||||||ANOVA|||Statistical analysis (P value) composite for all categories.||||0.364
72377397|NCT00992589|144263828|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|0.042||||0.96|TWO_SIDED|95.0|-1.615|1.7|||ANCOVA|||Analysis of Covariance with Treatment as fixed effect, Region and Age as stratification factors and Change from Open-label (OL) Baseline to OL Endpoint as covariate to test the hypothesis of no difference in change in I-GERQ-R Total Score from Double-blind (DB) Baseline to DB Endpoint between rabeprazole sodium total and placebo.||1.700|-1.615|0.960
72377398|NCT00992589|144263829|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|0.024||||0.968|TWO_SIDED|95.0|-1.167|1.214|||ANCOVA|||Analysis of Covariance with Treatment as fixed effect, Region and Age as stratification factors and Change from Open-label (OL) Baseline to OL Endpoint as covariate to test the hypothesis of no difference in change in Weekly Average I-GERQ-DD Total Score from Double-blind (DB) Baseline to DB Endpoint between rabeprazole sodium total and placebo.||1.214|-1.167|0.968
72377399|NCT02142387|144263830|OTHER|||||||0.34|TWO_SIDED|95.0|||||Chi-squared|||||||0.34
72377400|NCT02142387|144263831|OTHER|||||||0.7|||||||Chi-squared|||||||0.7
72377401|NCT02142387|144263832|OTHER|||||||0.11|||||||Chi-squared|||||||0.11
72377402|NCT01848782|144263833|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.5|TWO_SIDED|95.0|-0.4|0.7|||Mixed Models Analysis|||||0.7|-0.4|0.5
72377403|NCT01848782|144263834|SUPERIORITY||Mean Difference (Final Values)|0.07||||0.8|TWO_SIDED|95.0|-0.5|0.6|||Mixed Models Analysis|||||0.6|-0.5|0.8
72504984|NCT01462292|144541170|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.41||||0.541|TWO_SIDED|95.0|0.02|7.01||No adjustment for multiplicity was made, so p-values should not be used to make conclusions with regards to statistical significance|Regression, Logistic|Model includes terms for Treatment and Centre Grouping||Placebo (combined), GSK2402968 3 mg/kg/week||7.01|0.02|0.541
72377404|NCT01848782|144263835|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.6|TWO_SIDED|95.0|-0.4|0.7|||Mixed Models Analysis|||||0.7|-0.4|0.6
72377405|NCT01848782|144263836|SUPERIORITY||Mean Difference (Final Values)|-0.08||||0.8|TWO_SIDED|95.0|-0.6|0.5|||Mixed Models Analysis|||||0.5|-0.6|0.8
72377406|NCT01848782|144263837|SUPERIORITY||Mean Difference (Final Values)|-0.4||||0.2|TWO_SIDED|95.0|-1.0|0.2|||Mixed Models Analysis|||||0.2|-1.0|0.2
72377407|NCT01856764|144263839|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.55|STANDARD_ERROR_OF_MEAN|0.496||0.276|TWO_SIDED|95.0|-1.5542|0.4574||Mixed Model Repeated Measures (MMRM) Model: SCORAD change from baseline = treatment + visit + treatment by visit interaction + baseline SCORAD score|Mixed Models Analysis|||||0.4574|-1.5542|0.276
72377408|NCT01856764|144263840|SUPERIORITY_OR_OTHER||LS Mean Difference|-5.91|STANDARD_ERROR_OF_MEAN|3.454||0.095|TWO_SIDED|95.0|-12.9134|1.0835||MMRM model: TEWL change from baseline = treatment + visit + treatment by visit interaction + baseline TEWL score|Mixed Models Analysis|||||1.0835|-12.9134|0.095
72377409|NCT01856764|144263841|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.56|STANDARD_ERROR_OF_MEAN|0.596||0.013|TWO_SIDED|95.0|-2.7656|-0.3492||MMRM model: Assessment of Pruritus change from baseline = treatment + visit + treatment by visit interaction + baseline Assessment of Pruritus score|Mixed Models Analysis|||||-0.3492|-2.7656|0.013
72377410|NCT00609362|144263862|SUPERIORITY_OR_OTHER|||||||0.055||95.0||||P-value is un-adjusted. A priori threshold for significance: 0.05|t-test, 2 sided|||The minimum number of participants was determined by power calculations to be 44 (22 in each group), assuming a difference in change in BMD of 1.7%, a standard deviation of 2%, a power of 80%, and a level of significance of 5%.||||0.055
72377411|NCT00609362|144263863|SUPERIORITY_OR_OTHER|||||||0.056||95.0|||||t-test, 2 sided|||||||0.056
72377412|NCT00609362|144263864|SUPERIORITY_OR_OTHER|||||||0.003||95.0|||||t-test, 2 sided|||||||0.003
72377413|NCT00548405|144263873|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.58||||0.0084|TWO_SIDED|95.0|0.38|0.87||Hochberg method was used to adjust for the two co-primary outcomes.|Cox Proportional Hazards Regression|||Cox proportional hazards (PH) regression model with robust variance estimation using treatment group and geographic region as covariate was used.||0.87|0.38|0.0084
72377414|NCT00548405|144263874|SUPERIORITY_OR_OTHER||Rate ratio|0.51|||<|0.0001|TWO_SIDED|95.0|0.39|0.65||Hochberg method was used to adjust for the two co-primary outcomes.|Proportional means regression|||Proportional means regression model with robust variance estimation and covariate adjustment for geographic region was used.||0.65|0.39|<0.0001
72377415|NCT00548405|144263875|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.53|||<|0.0001|TWO_SIDED|95.0|0.41|0.69|||Cox Proportional Hazards Regression|||Cox PH regression model with robust variance estimation and covariate adjustment for geographic region was used.||0.69|0.41|<0.0001
72377416|NCT00548405|144263876|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wei-Lachin|||The analysis was performed using Wei-Lachin method for non-parametric analysis of repeated measures.||||<0.0001
72377417|NCT00548405|144263877|SUPERIORITY_OR_OTHER|||||||0.0022|||||||Wei-Lachin|||Change at Year 2: the analysis was performed using Wei-Lachin method for non-parametric analysis of repeated measures.||||0.0022
72377418|NCT00548405|144263878|SUPERIORITY_OR_OTHER|||||||0.1371|TWO_SIDED||||||Ranked ANCOVA|||Ranked ANCOVA models with covariate adjustment for geographic region and Baseline T2 lesion volume was used.||||0.1371
72377419|NCT03102190|144263879|OTHER||||||||||||||||||The analysis of the safety endpoints will be presented with means and standard deviations of their occurrence within the study population. The safety of the drug will be determined by analyzing the rate of adverse events in both phases of the trial. An occurrence of 10% within the study population will be considered significant.|||
72377420|NCT02582684|144263888|OTHER|Binomial Proportion of Participants with Virologic Success and 95% Confidence Interval|proportion|0.9|||||TWO_SIDED|95.0|0.83|0.95|||||Confidence interval was calculated using the Clopper-Pearson exact method.|||0.95|0.83|
72377421|NCT02582684|144263889|OTHER|Binomial Proportion of Participants with Virologic Success and 95% Confidence Interval|Proportion|0.89|||||TWO_SIDED|95.0|0.82|0.94|||||Confidence interval was calculated using the Clopper-Pearson exact method.|||0.94|0.82|
72377422|NCT02582684|144263890|OTHER|Binomial Proportion of Participants with Virologic Success and 95% Confidence Interval|proportion|0.85|||||TWO_SIDED|95.0|0.77|0.91|||||Confidence interval was calculated using the Clopper-Pearson exact method.|||0.91|0.77|
72377423|NCT01431300|144263911|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|54.0|STANDARD_DEVIATION|12.0|<|0.01|TWO_SIDED|95.0|||||t-test, 2 sided|||signal-to-noise (SNR) ratios of the central veins in the 0.01 mmol/kg and 0.03mmol/kg dose groups were compared.||||<0.01
72377424|NCT01431300|144263911|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|43.0|STANDARD_DEVIATION|19.0|<|0.01||95.0|||||t-test, 2 sided|||contrast-to-noise (CNR) ratios of the central veins in the 0.01 mmol/kg and 0.03mmol/kg dose groups were compared.||||<0.01
72377425|NCT06054269|144263912|SUPERIORITY|||||||0.004|||||||Wilcoxon (Mann-Whitney)|||For comparison of post-vaccination geometric mean antibody titers to the influenza A(H1N1)pdm09 vaccine virus between recipients of FLUAD Quadrivalent and FluQuadri.||||0.004
72377426|NCT06054269|144263912|SUPERIORITY|||||||0.066|||||||Wilcoxon (Mann-Whitney)|||For comparison of post-vaccination geometric mean antibody titers to the influenza A(H3N2) vaccine virus between recipients of FLUAD Quadrivalent and FluQuadri.||||0.066
72377427|NCT06054269|144263912|SUPERIORITY|||||||0.694|||||||Wilcoxon (Mann-Whitney)|||For comparison of post-vaccination geometric mean antibody titers to the influenza B/Victoria vaccine virus between recipients of FLUAD Quadrivalent and FluQuadri.||||0.694
72377428|NCT06054269|144263912|SUPERIORITY|||||||0.408|||||||Wilcoxon (Mann-Whitney)|||For comparison of post-vaccination geometric mean antibody titers to the influenza B/Yamagata vaccine virus between recipients of FLUAD Quadrivalent and FluQuadri.||||0.408
72377429|NCT06054269|144263913|SUPERIORITY|||||||0.164|||||||Wilcoxon (Mann-Whitney)|||For comparison of post-vaccination geometric mean antibody titers to the influenza A(H1N1)pdm09 vaccine virus between recipients of FLUAD Quadrivalent and FluQuadri.||||0.164
72377430|NCT06054269|144263913|SUPERIORITY|||||||0.113|||||||Wilcoxon (Mann-Whitney)|||For comparison of post-vaccination geometric mean antibody titers to the influenza A(H3N2) vaccine virus between recipients of FLUAD Quadrivalent and FluQuadri.||||0.113
72377431|NCT06054269|144263913|SUPERIORITY|||||||0.404|||||||Wilcoxon (Mann-Whitney)|||For comparison of post-vaccination geometric mean antibody titers to the influenza B/Victoria vaccine virus between recipients of FLUAD Quadrivalent and FluQuadri.||||0.404
72377432|NCT06054269|144263913|SUPERIORITY|||||||0.879|||||||Wilcoxon (Mann-Whitney)|||For comparison of post-vaccination geometric mean antibody titers to the influenza B/Yamagata vaccine virus between recipients of FLUAD Quadrivalent and FluQuadri.||||0.879
72377433|NCT06054269|144263914|SUPERIORITY||||||<|0.001|||||||Chi-squared|||For comparison of post-vaccination seroconversion rate to the influenza A(H1N1)pdm09 vaccine virus between recipients of FLUAD Quadrivalent and FluQuadri.||||<0.001
72377434|NCT06054269|144263914|SUPERIORITY|||||||0.002|||||||Chi-squared|||For comparison of post-vaccination seroconversion rate to the influenza A(H3N2) vaccine virus between recipients of FLUAD Quadrivalent and FluQuadri.||||0.002
72377435|NCT06054269|144263914|SUPERIORITY|||||||0.468|||||||Chi-squared|||For comparison of post-vaccination seroconversion rate to the influenza B/Victoria vaccine virus between recipients of FLUAD Quadrivalent and FluQuadri.||||0.468
72377436|NCT06054269|144263914|SUPERIORITY|||||||0.057|||||||Chi-squared|||For comparison of post-vaccination seroconversion rate to the influenza B/Yamagata vaccine virus between recipients of FLUAD Quadrivalent and FluQuadri.||||0.057
72377437|NCT06054269|144263915|SUPERIORITY|||||||0.112|||||||Chi-squared|||For comparison of post-vaccination seroconversion rate to the influenza A(H1N1)pdm09 vaccine virus between recipients of FLUAD Quadrivalent and FluQuadri.||||0.112
72377438|NCT06054269|144263915|SUPERIORITY|||||||0.149|||||||Chi-squared|||For comparison of post-vaccination seroconversion rate to the influenza A(H3N2) vaccine virus between recipients of FLUAD Quadrivalent and FluQuadri.||||0.149
72377439|NCT06054269|144263915|SUPERIORITY|||||||0.101|||||||Chi-squared|||For comparison of post-vaccination seroconversion rate to the influenza B/Victoria vaccine virus between recipients of FLUAD Quadrivalent and FluQuadri.||||0.101
72377440|NCT06054269|144263915|SUPERIORITY|||||||0.259|||||||Chi-squared|||For comparison of post-vaccination seroconversion rate to the influenza B/Yamagata vaccine virus between recipients of FLUAD Quadrivalent and FluQuadri.||||0.259
72377441|NCT06054269|144263916|SUPERIORITY|||||||0.097|||||||Chi-squared|||For comparison of post-vaccination seroprotection rate to the influenza A(H1N1)pdm09 vaccine virus between recipients of FLUAD Quadrivalent and FluQuadri.||||0.097
72377442|NCT06054269|144263916|SUPERIORITY|||||||0.733|||||||Chi-squared|||For comparison of post-vaccination seroprotection rate to the influenza A(H3N2) vaccine virus between recipients of FLUAD Quadrivalent and FluQuadri.||||0.733
72377443|NCT06054269|144263916|SUPERIORITY|||||||0.477|||||||Chi-squared|||For comparison of post-vaccination seroprotection rate to the influenza B/Victoria vaccine virus between recipients of FLUAD Quadrivalent and FluQuadri.||||0.477
72377444|NCT06054269|144263916|SUPERIORITY|||||||0.312|||||||Chi-squared|||For comparison of post-vaccination seroprotection rate to the influenza B/Yamagata vaccine virus between recipients of FLUAD Quadrivalent and FluQuadri.||||0.312
72377445|NCT06054269|144263917|SUPERIORITY|||||||0.22|||||||Chi-squared|||For comparison of post-vaccination seroprotection rate to the influenza A(H1N1)pdm09 vaccine virus between recipients of FLUAD Quadrivalent and FluQuadri.||||0.220
72377446|NCT06054269|144263917|SUPERIORITY|||||||0.003|||||||Chi-squared|||For comparison of post-vaccination seroprotection rate to the influenza A(H3N2) vaccine virus between recipients of FLUAD Quadrivalent and FluQuadri.||||0.003
72377447|NCT06054269|144263917|SUPERIORITY|||||||0.897|||||||Chi-squared|||For comparison of post-vaccination seroprotection rate to the influenza B/Victoria vaccine virus between recipients of FLUAD Quadrivalent and FluQuadri.||||0.897
72377448|NCT06054269|144263917|SUPERIORITY|||||||0.931|||||||Chi-squared|||For comparison of post-vaccination seroprotection rate to the influenza B/Yamagata vaccine virus between recipients of FLUAD Quadrivalent and FluQuadri.||||0.931
72377449|NCT00899392|144263936|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Student's t test|t-test, 2 sided|||||||<0.0001
72377450|NCT00899392|144263937|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||Wilcoxon (Mann-Whitney)|||Mann Whitney Test-non parametric||||>0.05
72377451|NCT00899392|144263938|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||t-test, 2 sided|paired||||||>0.05
72377452|NCT00899392|144263939|SUPERIORITY_OR_OTHER|||||||0.0053||95.0|||||t-test, 2 sided|||||||0.0053
72377453|NCT00402233|144263995|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.4|||<|0.0001||95.0|-6.53|-2.26|||ANCOVA|||||-2.26|-6.53|<0.0001
72377454|NCT00402233|144263995|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.41|||<|0.0001||95.0|-6.54|-2.28|||ANCOVA|||||-2.28|-6.54|<0.0001
72377455|NCT00402233|144263995|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.72|||<|0.0001||95.0|-6.91|-2.52|||ANCOVA|||||-2.52|-6.91|<0.0001
72377456|NCT00402233|144263996|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.893||||||95.0|0.431|1.849|||Regression, Logistic|||||1.849|0.431|
72377457|NCT00402233|144263996|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.885||||||95.0|0.424|1.845|||Regression, Logistic|||||1.845|0.424|
72377458|NCT00402233|144263996|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.687||||||95.0|0.317|1.492|||Regression, Logistic|||||1.492|0.317|
72377459|NCT00402233|144263997|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.14||||0.014||95.0|0.23|2.04|||ANCOVA|||||2.04|0.23|0.014
72377460|NCT00402233|144263997|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.0||||0.03||95.0|0.094|1.9|||ANCOVA|||||1.9|0.094|0.03
72556206|NCT03930732|144643541|SUPERIORITY||LS Mean Difference|-1.137||||0.0012|TWO_SIDED|95.0|-1.823|-0.45||Threshold for significance at 0.049 level.|MMRM model|||Derived from MMRM model with the change from baseline in E-RS: COPD RS-Total Score to Week 52 as response variables, and treatment group, region (pooled country), ICS dose, smoking status at screening, visit, treatment-by-visit interaction, baseline E-RS: COPD RS-Total Score, and baseline E-RS: COPD RS-Total Score-by-visit interaction as covariates. Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-0.450|-1.823|0.0012
72556207|NCT03930732|144643542|SUPERIORITY|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).|Risk Difference (RD)|-0.418||||0.0052|TWO_SIDED|95.0|-0.728|-0.109||Threshold for significance at 0.049 level.|Negative binomial model||Derived using delta method.|Derived using negative binomial model with the total number of the events occurring during the 52-week treatment period as the response variable, and treatment group, region (pooled country), ICS dose, smoking status at screening, baseline disease severity, and number of moderate or severe COPD exacerbation events within one year prior to the study as covariates, and log-transformed treatment duration as an offset variable.||-0.109|-0.728|0.0052
72377461|NCT00402233|144263997|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.49||||0.0019||95.0|0.56|2.43|||ANCOVA|||||2.43|0.56|0.0019
72377462|NCT00402233|144263998|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.55||||0.39||95.0|-1.82|0.71|||ANCOVA|||||0.71|-1.82|0.39
72377463|NCT00402233|144263998|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.57||||0.37||95.0|-1.84|0.69|||ANCOVA|||||0.69|-1.84|0.37
72377464|NCT00402233|144263998|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.47||||0.48||95.0|-1.78|0.84|||ANCOVA|||||0.84|-1.78|0.48
72377465|NCT04721067|144264043|SUPERIORITY||Mean Difference (Net)|-2.27||||0.607|TWO_SIDED|95.0|-15.14|10.6|||Regression, Logistic|Adjusted for baseline values||||10.60|-15.14|0.607
72377466|NCT04721067|144264044|SUPERIORITY||Mean Difference (Net)|-2.99||||0.766|TWO_SIDED|95.0|-10.74|4.76|||ANCOVA|||||4.76|-10.74|0.766
72556208|NCT04708028|144643559|SUPERIORITY|||||||0.379|||||||Wilcoxon (Mann-Whitney)|||Baseline||||0.379
72377467|NCT04721067|144264045|SUPERIORITY||Mean Difference (Net)|145.54||||0.465|TWO_SIDED|95.0|-264.05|555.14|||ANCOVA|||||555.14|-264.05|0.465
72377468|NCT04721067|144264046|SUPERIORITY||Mean Difference (Net)|137.79||||0.178|TWO_SIDED|95.0|-68.71|344.3|||ANCOVA|||||344.30|-68.71|0.178
72377469|NCT04721067|144264047|SUPERIORITY||Mean Difference (Net)|1.87||||0.548|TWO_SIDED|95.0|-4.58|8.31|||ANCOVA|||||8.31|-4.58|0.548
72377470|NCT04721067|144264048|SUPERIORITY||Mean Difference (Net)|-0.67||||0.579|TWO_SIDED|95.0|-3.14|1.8|||ANCOVA|||||1.80|-3.14|0.579
72377471|NCT04721067|144264049|SUPERIORITY||Mean Difference (Net)|-0.63||||0.766|TWO_SIDED|95.0|-5.0|3.74|||ANCOVA|||||3.74|-5.00|0.766
72377472|NCT04721067|144264050|SUPERIORITY||Mean Difference (Net)|-1.23||||0.42|TWO_SIDED|95.0|-4.39|1.93|||ANCOVA|||||1.93|-4.39|0.42
72377473|NCT04721067|144264051|SUPERIORITY||Mean Difference (Net)|-0.07||||0.91|TWO_SIDED|95.0|-1.34|1.2|||ANCOVA|||||1.20|-1.34|0.91
72377474|NCT04721067|144264052|SUPERIORITY||Mean Difference (Net)|0.79||||0.73|TWO_SIDED|95.0|-4.03|5.6|||ANCOVA|||||5.60|-4.03|0.73
72377475|NCT04721067|144264053|SUPERIORITY||Mean Difference (Net)|0.19||||0.42|TWO_SIDED|95.0|-0.3|0.68|||ANCOVA|||||0.68|-0.30|0.42
72377476|NCT04721067|144264054|SUPERIORITY||Mean Difference (Net)|1.79||||0.18|TWO_SIDED|95.0|-0.9|4.48|||ANCOVA|||||4.48|-0.90|0.18
72377477|NCT04721067|144264055|SUPERIORITY||Mean Difference (Net)|-2.03||||0.48|TWO_SIDED|95.0|-7.97|3.9|||ANCOVA|||||3.90|-7.97|0.48
72377478|NCT04721067|144264056|SUPERIORITY||Mean Difference (Net)|1.42||||0.08|TWO_SIDED|95.0|-0.24|3.08|||ANCOVA|||||3.08|-0.24|0.08
72377479|NCT04721067|144264057|SUPERIORITY||Mean Difference (Net)|0.51||||0.94|TWO_SIDED|95.0|-13.5|14.52|||ANCOVA|||||14.52|-13.50|0.94
72377480|NCT04721067|144264060|SUPERIORITY||Mean Difference (Final Values)|0.43||||0.32|TWO_SIDED|95.0|-0.45|1.32|||t-test, 2 sided|||||1.32|-0.45|0.32
72377481|NCT04721067|144264061|SUPERIORITY||Mean Difference (Final Values)|0.25||||0.61|TWO_SIDED|95.0|-0.75|1.25|||t-test, 2 sided|||||1.25|-0.75|0.61
72377482|NCT04721067|144264062|SUPERIORITY||Mean Difference (Net)|-1.05||||0.52|TWO_SIDED|95.0|-4.42|2.31|||ANCOVA|||||2.31|-4.42|0.52
72377483|NCT04721067|144264063|SUPERIORITY||Mean Difference (Net)|-0.44||||0.61|TWO_SIDED|95.0|-2.2|1.32|||ANCOVA|||||1.32|-2.20|0.61
72377484|NCT04721067|144264064|SUPERIORITY||Mean Difference (Net)|3.68||||0.16|TWO_SIDED|95.0|-1.61|8.97|||ANCOVA|||||8.97|-1.61|0.16
72377485|NCT04721067|144264065|SUPERIORITY||Mean Difference (Net)|0.43||||0.13|TWO_SIDED|95.0|-0.13|1.0|||ANCOVA|||||1.00|-0.13|0.13
72377486|NCT04721067|144264066|SUPERIORITY||Mean Difference (Net)|3.88||||0.03|TWO_SIDED|95.0|0.35|7.41|||ANCOVA|||||7.41|0.35|0.03
72377487|NCT04721067|144264067|SUPERIORITY||Mean Difference (Net)|-3.2||||0.41|TWO_SIDED|95.0|-11.07|4.66|||ANCOVA|||||4.66|-11.07|0.41
72377488|NCT04721067|144264068|SUPERIORITY||Mean Difference (Net)|1.7||||0.17|TWO_SIDED|95.0|-0.83|4.22|||ANCOVA|||||4.22|-0.83|0.17
72377489|NCT04721067|144264069|SUPERIORITY||Mean Difference (Net)|3.49||||0.58|TWO_SIDED|95.0|-9.58|16.55|||ANCOVA|||||16.55|-9.58|0.58
72377490|NCT04721067|144264070|SUPERIORITY||Mean Difference (Net)|0.15||||0.74|TWO_SIDED|95.0|-0.79|1.1|||ANCOVA|||||1.10|-0.79|0.74
72377491|NCT04721067|144264071|SUPERIORITY||Mean Difference (Net)|129.077||||0.17|TWO_SIDED|95.0|-57.78|315.92|||ANCOVA|||||315.92|-57.78|0.17
72377492|NCT04721067|144264072|SUPERIORITY||Mean Difference (Net)|109.71||||0.31|TWO_SIDED|95.0|-108.37|327.78|||ANCOVA|||||327.78|-108.37|0.31
72377493|NCT04721067|144264073|SUPERIORITY||Mean Difference (Net)|0.24||||0.92|TWO_SIDED|95.0|-4.52|5.0|||ANCOVA|||||5.00|-4.52|0.92
72377494|NCT04721067|144264074|SUPERIORITY||Mean Difference (Net)|-1.11||||0.66|TWO_SIDED|95.0|-6.28|4.06|||ANCOVA|||||4.06|-6.28|0.66
72377495|NCT02233478|144264075|OTHER||Mean Difference (Final Values)|0.001||||0.82|TWO_SIDED||||||t-test, 2 sided|||"Comparison of ellagic acid concentration 0 to 24 hours post-dose area under the curve was made to PJ alone vs. PJ with soy protein after intervention.~Due to the quality issue of soybean flour, data from this intervention group was not analyzed."||||0.82
72377496|NCT00873873|144264078|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2||95.0|||||ANOVA|||Is there a difference in airway wall thickness among the 4 groups?||||0.2
72377497|NCT00604214|144264089|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.088||||0.313|TWO_SIDED|95.0|0.923|1.283||No adjustment for multiple comparisons.|Chi-squared|||The study was planned to have 80% power to detect a 20% relative risk reduction in 28-day all-cause mortality in drotrecogin alpha (activated) compared to placebo. The final power was 75% because of the lower than anticipated placebo mortality.||1.283|0.923|0.313
72377498|NCT00604214|144264090|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.93||||0.54|TWO_SIDED|95.0|0.737|1.173||No adjustments for multiple comparisons.|Chi-squared|||||1.173|0.737|0.540
72377499|NCT00604214|144264091|SUPERIORITY_OR_OTHER|||||||0.181||95.0||||No adjustments for multiple comparisons.|ANOVA|||||||0.181
72377500|NCT00604214|144264092|SUPERIORITY_OR_OTHER|||||||0.733||95.0||||No adjustments for multiple comparisons.|ANOVA|||||||0.733
72377501|NCT00604214|144264093|SUPERIORITY_OR_OTHER|||||||0.122||95.0||||No adjustments for multiple comparisons.|ANOVA|||||||0.122
72377502|NCT00604214|144264094|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.042||||0.556|TWO_SIDED|95.0|0.909|1.193||No adjustments for multiple comparisons.|Chi-squared|||||1.193|0.909|0.556
72377503|NCT00604214|144264095|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.02||||0.758|TWO_SIDED|95.0|0.898|1.16||No adjustments for multiple comparisons.|Chi-squared|||||1.160|0.898|0.758
72377504|NCT00604214|144264097|SUPERIORITY_OR_OTHER|||||||0.788||95.0||||P-value is for Baseline, unadjusted for multiple comparisons.|ANOVA|||||||0.788
72377505|NCT00604214|144264097|SUPERIORITY_OR_OTHER|||||||0.73||95.0||||P-value is for Day 28, unadjusted for multiple comparisons.|ANOVA|||||||0.730
72556209|NCT04708028|144643559|SUPERIORITY|||||||0.646|||||||Wilcoxon (Mann-Whitney)|||8 minutes Post intervention (Dog exposure or no dog exposure)||||0.646
72556210|NCT04708028|144643559|SUPERIORITY|||||||0.219|||||||Wilcoxon (Mann-Whitney)|||8 minutes after starting dental procedure||||0.219
72377506|NCT00604214|144264097|SUPERIORITY_OR_OTHER|||||||0.662||95.0||||P-value is for Day 90, unadjusted for multiple comparisons.|ANOVA|||||||0.662
72377507|NCT00604214|144264097|SUPERIORITY_OR_OTHER|||||||0.846||95.0||||P-value is for Day 180, unadjusted for multiple comparisons.|ANOVA|||||||0.846
72377508|NCT00604214|144264098|SUPERIORITY_OR_OTHER|||||||0.697||95.0||||P-value is for Baseline, unadjusted for multiple comparisons.|ANOVA|||||||0.697
72377509|NCT00604214|144264098|SUPERIORITY_OR_OTHER|||||||0.306||95.0||||P-value is for Day 28, unadjusted for multiple comparisons.|ANOVA|||||||0.306
72377510|NCT00604214|144264098|SUPERIORITY_OR_OTHER|||||||0.645||95.0||||P-value is for Day 90, unadjusted for multiple comparisons.|ANOVA|||||||0.645
72377511|NCT00604214|144264098|SUPERIORITY_OR_OTHER|||||||0.69||95.0||||P-value is for Day 180, unadjusted for multiple comparisons.|ANOVA|||||||0.690
72377512|NCT00604214|144264099|SUPERIORITY_OR_OTHER|||||||0.482||95.0||||P-value is for physical component at Baseline, unadjusted for multiple comparisons.|ANOVA|||Analysis on ranked data.||||0.482
72377513|NCT00604214|144264099|SUPERIORITY_OR_OTHER|||||||0.584||95.0||||P-value is for physical component at Day 28, unadjusted for multiple comparisons.|ANOVA|||Analysis on ranked data.||||0.584
72377514|NCT00604214|144264099|SUPERIORITY_OR_OTHER|||||||0.164||95.0||||P-value is for physical component at Day 90, unadjusted for multiple comparisons.|ANOVA|||Analysis on ranked data.||||0.164
72377515|NCT00604214|144264099|SUPERIORITY_OR_OTHER|||||||0.666||95.0||||P-value is for physical component at Day 180, unadjusted for multiple comparisons.|ANOVA|||Analysis on ranked data.||||0.666
72377516|NCT00604214|144264099|SUPERIORITY_OR_OTHER|||||||0.786||95.0||||P-value is for mental component at Baseline, unadjusted for multiple comparisons.|ANOVA|||Analysis on ranked data.||||0.786
72377517|NCT00604214|144264099|SUPERIORITY_OR_OTHER|||||||0.16||95.0||||P-value is for mental component at Day 28, unadjusted for multiple comparisons.|ANOVA|||Analysis on ranked data.||||0.160
72377518|NCT00604214|144264099|SUPERIORITY_OR_OTHER|||||||0.696||95.0||||P-value is for mental component at Day 90, unadjusted for multiple comparisons.|ANOVA|||Analysis on ranked data.||||0.696
72377519|NCT00604214|144264099|SUPERIORITY_OR_OTHER|||||||0.966||95.0||||P-value is for mental component at Day 180, unadjusted for multiple comparisons.|ANOVA|||Analysis on ranked data.||||0.966
72377520|NCT00604214|144264100|SUPERIORITY_OR_OTHER|||||||0.758||95.0||||P-value is for participants with ≥1 event. No adjustments for multiple comparisons.|Fisher Exact|||||||0.758
72377521|NCT00604214|144264101|SUPERIORITY_OR_OTHER|||||||0.154||95.0||||Unadjusted for multiple comparisons.|Fisher Exact|||||||0.154
72377522|NCT02233946|144264110|SUPERIORITY||Cox Proportional Hazard|0.69|||||TWO_SIDED|95.0|0.47|1.02||||||Participants who reported past-12-month use of alcohol or other drugs at baseline||1.02|0.47|
72377523|NCT02233946|144264110|SUPERIORITY||Cox Proportional Hazard|0.87|||||TWO_SIDED|95.0|0.57|1.31||||||Participants who reported no past-12-month use of alcohol or other drugs at baseline||1.31|0.57|
72377524|NCT02233946|144264111|SUPERIORITY||Cox Proportional Hazard|0.66|||||TWO_SIDED|95.0|0.4|1.1||||||Participants who reported past-12-month use of alcohol or other drugs at baseline||1.10|0.40|
72377525|NCT02233946|144264112|SUPERIORITY|Participants who reported past-12-month use of alcohol or other drugs at baseline|Cox Proportional Hazard|0.62|||||TWO_SIDED|95.0|0.41|0.94||||||||0.94|0.41|
72377526|NCT02233946|144264112|SUPERIORITY||Cox Proportional Hazard|0.76|||||TWO_SIDED|95.0|0.44|1.32||||||Participants who reported no past-12-month use of alcohol or other drugs at baseline||1.32|0.44|
72377527|NCT02233946|144264113|SUPERIORITY||Risk Ratio (RR)|0.82|||||TWO_SIDED|95.0|0.5|1.34||||||"Participants with riding risk at baseline:~Adjusted Relative Risk Ratio (ARRR) of past-3-month riding risk at 6 months follow-up, cSBI vs. TAU."||1.34|0.50|
72377528|NCT02233946|144264113|SUPERIORITY||Risk Ratio (RR)|0.73|||||TWO_SIDED|95.0|0.44|1.19||||||"Participants with riding risk at baseline:~Adjusted Relative Risk Ratio (ARRR) of past-3-month riding risk at 9 months follow-up, cSBI vs. TAU."||1.19|0.44|
72377529|NCT02233946|144264113|SUPERIORITY||Risk Ratio (RR)|0.58|||||TWO_SIDED|95.0|0.37|0.91||||||"Participants with riding risk at baseline:~Adjusted Relative Risk Ratio (ARRR) of past-3-month riding risk at 12 months follow-up, cSBI vs. TAU."||0.91|0.37|
72377530|NCT02233946|144264113|SUPERIORITY||Risk Ratio (RR)|0.72|||||TWO_SIDED|95.0|0.43|1.23||||||"Participants with no riding risk at baseline:~Adjusted Relative Risk Ratio (ARRR) of past-3-month riding risk at 6 months follow-up, cSBI vs. TAU."||1.23|0.43|
72556211|NCT04708028|144643559|SUPERIORITY|||||||0.223|||||||Wilcoxon (Mann-Whitney)|||8 minutes after completion of dental procedure||||0.223
72556212|NCT04708028|144643560|SUPERIORITY|||||||0.41|||||||Wilcoxon (Mann-Whitney)|||Baseline||||0.410
72556213|NCT04708028|144643560|SUPERIORITY|||||||0.127|||||||Wilcoxon (Mann-Whitney)|||8 minutes Post intervention (Dog exposure or no dog exposure)||||0.127
72377531|NCT02233946|144264113|SUPERIORITY||Risk Ratio (RR)|1.33|||||TWO_SIDED|95.0|0.67|2.66||||||"Participants with no riding risk at baseline:~Adjusted Relative Risk Ratio (ARRR) of past-3-month riding risk at 9 months follow-up, cSBI vs. TAU."||2.66|0.67|
72377532|NCT02233946|144264113|SUPERIORITY||Risk Ratio (RR)|0.99|||||TWO_SIDED|95.0|0.5|1.99||||||"Participants with no riding risk at baseline:~Adjusted Relative Risk Ratio (ARRR) of past-3-month riding risk at 12 months follow-up, cSBI vs. TAU."||1.99|0.50|
72377533|NCT02927067|144264114|NON_INFERIORITY|Non-inferiority (NI) margin of primary efficacy endpoint was 7%. If lower limit of 95% confidence interval (CI) was greater than -7%, NI was assumed. Power calculation: Assuming 68% (maribavir), 60% (valganciclovir) participants achieve confirmed viremia clearance,494 participants (247 per group) would yield \>90% power to declare NI based on 2-group test of equivalence in proportions. Considering 10% dropout,550 participants (275 per group) were planned to be enrolled and randomized.|Difference in Percentage of Responders|-7.7|||||TWO_SIDED|95.0|-14.98|-0.36|||||Cochran-Mantel-Haenszel (CMH) weighted average approach (stratified for baseline plasma CMV DNA concentration and acute GVHD status) was used for adjusted difference in percentage of responders (Maribavir-Valganciclovir), 95% CI, and p-value.|||-0.36|-14.98|
72377534|NCT02927067|144264115|NON_INFERIORITY|The non-inferiority margin of the key secondary efficacy endpoint was 7%. If the lower limit of the 95% CI was greater than -7%, then noninferiority (NI) was assumed. Because the NI of the primary efficacy endpoint was not established, the NI hypothesis of the key secondary endpoint was not tested formally.|Difference in Percentage of Responders|4.4|||||TWO_SIDED|95.0|-3.91|12.76|||||CMH weighted average approach (stratified for baseline plasma CMV DNA concentration and acute GVHD status) was used for the adjusted difference in percentage of responders (Maribavir-Valganciclovir), the corresponding 95% CI, and the p-value.|||12.76|-3.91|
72377535|NCT02927067|144264116|SUPERIORITY||Difference in Percentage of Responders|8.0|||=|0.061|TWO_SIDED|95.0|-0.38|16.3||The CMH weighted average approach (stratified for baseline plasma CMV DNA concentration and acute GVHD status) was used for the adjusted difference in percentage of responders (Maribavir-Valganciclovir), the corresponding 95% CI, and the p-value.|Cochran-Mantel-Haenszel|||||16.30|-0.38|=0.061
72377536|NCT02927067|144264117|SUPERIORITY||Difference in Percentage of Responders|8.0|||=|0.061|TWO_SIDED|95.0|-0.38|16.3||The CMH weighted average approach (stratified for baseline plasma CMV DNA concentration and acute GVHD status) was used for the adjusted difference in percentage of responders (Maribavir-Valganciclovir), the corresponding 95% CI, and the p-value.|Cochran-Mantel-Haenszel|||Week 8||16.30|-0.38|=0.061
72377537|NCT02927067|144264117|SUPERIORITY||Difference in Percentage of Responders|13.4|||=|0.001|TWO_SIDED|95.0|5.23|21.62||The CMH weighted average approach (stratified for baseline plasma CMV DNA concentration and acute GVHD status) was used for the adjusted difference in percentage of responders (Maribavir-Valganciclovir), the corresponding 95% CI, and the p-value.|Cochran-Mantel-Haenszel|||Week 12||21.62|5.23|=0.001
72377538|NCT02927067|144264117|SUPERIORITY||Difference in Percentage of Responders|13.8|||<|0.001|TWO_SIDED|95.0|5.8|21.87||The CMH weighted average approach (stratified for baseline plasma CMV DNA concentration and acute GVHD status) was used for the adjusted difference in percentage of responders (Maribavir-Valganciclovir), the corresponding 95% CI, and the p-value.|Cochran-Mantel-Haenszel|||Week 16||21.87|5.80|<0.001
72377539|NCT02927067|144264117|SUPERIORITY||Difference in Percentage of Responders|9.7|||=|0.014|TWO_SIDED|95.0|1.98|17.5||The CMH weighted average approach (stratified for baseline plasma CMV DNA concentration and acute GVHD status) was used for the adjusted difference in percentage of responders (Maribavir-Valganciclovir), the corresponding 95% CI, and the p-value.|Cochran-Mantel-Haenszel|||Week 20||17.50|1.98|=0.014
72377540|NCT02927067|144264118|SUPERIORITY||Difference in Percentage of Responders|-7.3|||=|0.051|TWO_SIDED|95.0|-14.64|0.02||The CMH weighted average approach (stratified for baseline plasma CMV DNA concentration and acute GVHD status) was used for the adjusted difference in percentage of responders (Maribavir-Valganciclovir), the corresponding 95% CI, and the p-value.|Cochran-Mantel-Haenszel|||Week 8||0.02|-14.64|=0.051
72377541|NCT02927067|144264118|SUPERIORITY||Difference in Percentage of Responders|2.2|||=|0.606|TWO_SIDED|95.0|-6.05|10.37||The CMH weighted average approach (stratified for baseline plasma CMV DNA concentration and acute GVHD status) was used for the adjusted difference in percentage of responders (Maribavir-Valganciclovir), the corresponding 95% CI, and the p-value.|Cochran-Mantel-Haenszel|||Week 12||10.37|-6.05|=0.606
72377542|NCT02927067|144264118|SUPERIORITY||Difference in Percentage of Responders|1.0|||=|0.809|TWO_SIDED|95.0|-7.27|9.31||The CMH weighted average approach (stratified for baseline plasma CMV DNA concentration and acute GVHD status) was used for the adjusted difference in percentage of responders (Maribavir-Valganciclovir), the corresponding 95% CI, and the p-value.|Cochran-Mantel-Haenszel|||Week 20||9.31|-7.27|=0.809
72377543|NCT01727700|144264133|SUPERIORITY_OR_OTHER||Treatment difference|-6.26||||0.002|TWO_SIDED|95.0|-10.18|-2.34||The Hochberg procedure was used to adjust for multiplicity.|Mixed Models Analysis|Treatment, week, treatment by week interaction, region, and weight group were fixed categorical effects; baseline value as a fixed covariate.||Assuming 5% of participants may drop out of the trial without a postbaseline efficacy evaluation, a total of 126 participants were required to provide at least 80% power to detect a treatment difference of -5 (common standard deviation \[SD\] of 8.5) between at least 1 of 2 aripiprazole dose levels and placebo in the primary outcome.||-2.34|-10.18|0.0020
72377544|NCT01727700|144264133|SUPERIORITY_OR_OTHER||Treatment difference|-9.85|||<|0.0001|TWO_SIDED|95.0|-13.84|-5.86||The Hochberg procedure was used to adjust for multiplicity.|Mixed Models Analysis|Treatment, week, treatment by week interaction, region, and weight group were fixed categorical effects; baseline value as a fixed covariate.||Assuming 5% of participants may drop out of the trial without a postbaseline efficacy evaluation, a total of 126 participants were required to provide at least 80% power to detect a treatment difference of -5 (common standard SD of 8.5) between at least 1 of 2 aripiprazole dose levels and placebo in the primary outcome.||-5.86|-13.84|<0.0001
72433596|NCT00991276|144380368|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|20.93|STANDARD_ERROR_OF_MEAN|4.2|<|0.0001|TWO_SIDED|95.0|12.61|29.25||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||Stage N3 sleep/SWS: P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||29.25|12.61|<0.0001
72377545|NCT01727700|144264134|SUPERIORITY_OR_OTHER||Treatment difference|-1.03||||0.0001|TWO_SIDED|95.0|-1.54|-0.52||The Hochberg procedure was used to adjust for multiplicity.|Mixed Models Analysis|Treatment, week, treatment by week interaction, region, and weight group were fixed categorical effects; baseline value as a fixed covariate.||||-0.52|-1.54|0.0001
72377546|NCT01727700|144264134|SUPERIORITY_OR_OTHER||Treatment difference|-1.02||||0.0002|TWO_SIDED|95.0|-1.54|-0.49||The Hochberg procedure was used to adjust for multiplicity.|Mixed Models Analysis|Treatment, week, treatment by week interaction, region, and weight group were fixed categorical effects; baseline value as a fixed covariate.||||-0.49|-1.54|0.0002
72377547|NCT01727700|144264135|SUPERIORITY_OR_OTHER||Treatment difference|-13.26||||0.0017|TWO_SIDED|95.0|-21.43|-5.08||Treatment, week, treatment by week interaction, region, and weight group were fixed categorical effects; baseline value as a fixed covariate.|Mixed Models Analysis|||||-5.08|-21.43|0.0017
72377548|NCT01727700|144264135|SUPERIORITY_OR_OTHER||Treatment difference|-19.37|||<|0.0001|TWO_SIDED|95.0|-27.7|-11.04||Treatment, week, treatment by week interaction, region, and weight group were fixed categorical effects; baseline value as a fixed covariate.|Mixed Models Analysis|||||-11.04|-27.70|<0.0001
72377549|NCT01727700|144264136|SUPERIORITY_OR_OTHER||Treatment difference|-0.8||||0.001|TWO_SIDED|95.0|-1.27|-0.33||Treatment, week, treatment by week interaction, region, and weight group were fixed categorical effects; baseline value as a fixed covariate.|Mixed Models Analysis|||||-0.33|-1.27|0.0010
72377550|NCT01727700|144264136|SUPERIORITY_OR_OTHER||MMRM|-0.92||||0.0002|TWO_SIDED|95.0|-1.41|-0.44||Treatment, week, treatment by week interaction, region, and weight group were fixed categorical effects; baseline value as a fixed covariate.|Mixed Models Analysis|||||-0.44|-1.41|0.0002
72377551|NCT01727700|144264137|SUPERIORITY_OR_OTHER||Response ratio|1.36||||0.0835|TWO_SIDED|95.0|0.98|1.88||P-value derived from Cochran-Mantel-Haenszel (CMH) General Association Test adjusting for region and weight group.|Cochran-Mantel-Haenszel|Response ratio \> 1 favors aripiprazole.||||1.88|0.98|0.0835
72377552|NCT01727700|144264137|SUPERIORITY_OR_OTHER||Response ratio|1.61||||0.0014|TWO_SIDED|95.0|1.2|2.16||P-value derived from CMH General Association Test adjusting for region and weight group.|Cochran-Mantel-Haenszel|Response ratio \> 1 favors aripiprazole.||||2.16|1.20|0.0014
72377553|NCT01727700|144264138|SUPERIORITY_OR_OTHER||Discontinuation ratio|1.16||||0.9187|TWO_SIDED|95.0|0.19|7.05||Discontinuation ratio \< 1 favors aripiprazole. P-value derived from CMH General Association Test adjusting for region and weight group.|Cochran-Mantel-Haenszel|||||7.05|0.19|0.9187
72377554|NCT01727700|144264138|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.05||||0.9576||||||Hazard ratio \< 1 favors aripiprazole. P-value derived from Cox proportional hazard regression adjusting for region and weight group.|Regression, Cox|||||||0.9576
72377555|NCT01727700|144264138|SUPERIORITY_OR_OTHER||Discontinuation ratio|4.06||||0.0132|TWO_SIDED|95.0|1.1|14.95||Discontinuation ratio \< 1 favors aripiprazole. P-value derived from CMH General Association Test adjusting for region and weight group.|Cochran-Mantel-Haenszel|||||14.95|1.10|0.0132
72377556|NCT01727700|144264138|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|5.51||||0.0278||||||Hazard ratio \< 1 favors aripiprazole. P-value derived from Cox proportional hazard regression adjusting for region and weight group.|Regression, Cox|||||||0.0278
72556214|NCT04708028|144643560|SUPERIORITY|||||||0.268|||||||Wilcoxon (Mann-Whitney)|||8 minutes after starting dental procedure||||0.268
72377557|NCT02484859|144264149|SUPERIORITY||||||>|0.69|||||||Wilcoxon (Mann-Whitney)|||Median intraoperative bleeding scores were compared with Wilcoxon test. In this pilot study the power analysis showed that a sample size of 44 patients in each group was sufficient to detect a difference of 0.2 in the mean (standard deviation of 0.4) with an 80% power with an alpha error of 0.05 and a beta error of 20%. The Shapiro-Wilk test was used to test the distribution of data.||||>0.69
72377558|NCT02484859|144264150|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
72377559|NCT02484859|144264151|SUPERIORITY|||||||0.052|||||||t-test, 2 sided|||||||0.052
72377560|NCT02484859|144264152|SUPERIORITY|||||||0.05|||||||Chi-squared|||Null hypothesis was that the visual analog pain scores (VAS) of patients at arrrival to post anesthetic care unit (PACU) were similar.||||0.05
72377561|NCT02484859|144264152|SUPERIORITY|||||||0.55|||||||Chi-squared|||Null hypothesis was that the visual analog pain scores (VAS) of patients at discharge from post anesthetic care unit (PACU) were similar.||||0.55
72377562|NCT02484859|144264153|SUPERIORITY|||||||0.47|||||||Chi-squared|||||||0.47
72377563|NCT02054481|144264154|SUPERIORITY_OR_OTHER||Mean Difference (Net)|36.4|||<|0.0001|TWO_SIDED|95.0|19.0|53.8|||Cochran-Mantel-Haenszel|Adjusted for weight (=\<100kg vs \>100kg) \& prior exposure to 2 or more tumour necrosis factor antagonists with discontinuation due to lack of efficacy|Difference calculated as BI 90+180 mg minus Stelara|||53.8|19.0|<0.0001
72377564|NCT02054481|144264155|SUPERIORITY_OR_OTHER||Mean Difference (Net)|14.6||||0.0355|TWO_SIDED|95.0|1.0|28.2|||Cochran-Mantel-Haenszel|Adjusted for weight (=\<100kg vs \>100kg) \& prior exposure to 2 or more tumour necrosis factor antagonists with discontinuation due to lack of efficacy|Difference calculated as BI 90+180 mg minus Stelara|Week 12||28.2|1.0|0.0355
72377565|NCT02054481|144264155|SUPERIORITY_OR_OTHER||Mean Difference (Net)|21.1||||0.0062|TWO_SIDED|95.0|6.0|36.2|||Cochran-Mantel-Haenszel|Adjusted for weight (=\<100kg vs \>100kg) \& prior exposure to 2 or more tumour necrosis factor antagonists with discontinuation due to lack of efficacy|Difference calculated as BI 90+180 mg minus Stelara|Week 24||36.2|6.0|0.0062
72377566|NCT02054481|144264156|SUPERIORITY_OR_OTHER||Mean Difference (Net)|27.1||||0.0008|TWO_SIDED|95.0|11.3|42.9|||Cochran-Mantel-Haenszel|Adjusted for weight (=\<100kg vs \>100kg) \& prior exposure to 2 or more tumour necrosis factor antagonists with discontinuation due to lack of efficacy|Difference calculated as BI 90+180 mg minus Stelara|||42.9|11.3|0.0008
72377567|NCT02054481|144264157|SUPERIORITY_OR_OTHER||Mean Difference (Net)|10.1||||0.0706|TWO_SIDED|95.0|-0.8|21.1|||Cochran-Mantel-Haenszel|Adjusted for weight (=\<100kg vs \>100kg) \& prior exposure to 2 or more tumour necrosis factor antagonists with discontinuation due to lack of efficacy|Difference calculated as BI 90+180 mg minus Stelara|||21.1|-0.8|0.0706
72556215|NCT04708028|144643560|SUPERIORITY|||||||0.353|||||||Wilcoxon (Mann-Whitney)|||8 minutes after completion of dental procedure||||0.353
72556216|NCT02450539|144643563|SUPERIORITY||Hazard Ratio (HR)|1.765||||0.0068|TWO_SIDED|95.0|1.165|2.672|||Stratified log-rank test.||Stratified Cox proportional hazard model|Stratified by baseline ECOG performance status (0 vs 1), number of Prior Therapies (received only platinum-based therapy vs Received platinum-based Therapy plus Immune Checkpoint Inhibitor), and time since initiation of first line therapy (\<=9 months vs \>9 months).||2.672|1.165|0.0068
72377568|NCT02054481|144264158|SUPERIORITY_OR_OTHER||Mean Difference (Net)|19.8||||0.03|TWO_SIDED|95.0|1.9|37.7|||Cochran-Mantel-Haenszel|Adjusted for weight (=\<100kg vs \>100kg) \& prior exposure to 2 or more tumour necrosis factor antagonists with discontinuation due to lack of efficacy|Difference calculated as BI 90+180 mg minus Stelara|||37.7|1.9|0.0300
72377569|NCT02054481|144264160|SUPERIORITY_OR_OTHER||Mean Difference (Net)|21.2||||0.0072|TWO_SIDED|95.0|5.7|36.6|||Cochran-Mantel-Haenszel|Adjusted for weight (=\<100kg vs \>100kg) \& prior exposure to 2 or more tumour necrosis factor antagonists with discontinuation due to lack of efficacy|Difference calculated as BI 90+180 mg minus Stelara|||36.6|5.7|0.0072
72377570|NCT02054481|144264161|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.1844|||<|0.0001|TWO_SIDED|95.0|0.1|0.4|||Log Rank|||||0.4|0.1|<0.0001
72377571|NCT01842633|144264202|SUPERIORITY_OR_OTHER||Treatment Difference|-0.47|||||TWO_SIDED|95.0|-1.36|0.42||||||||0.42|-1.36|
72377572|NCT00178503|144264216|SUPERIORITY_OR_OTHER||Linear trend P value|0.0|||=|0.001|||||||ANOVA|||Data were analyzed using SPSS-PC repeated measures one-way analysis of variance (ANOVA), with MPH dosing regimen as the within-subjects variable.||||=.001
72377573|NCT00178503|144264217|SUPERIORITY_OR_OTHER||Linear p|0.005||||0.005|||||||ANOVA|||||||.005
72377574|NCT00178503|144264218|SUPERIORITY_OR_OTHER||Linear p|0.0|||<|0.001||0.0|||||ANOVA|||||||<.001
72377575|NCT02093351|144264233|EQUIVALENCE|If the 90% confidence interval (CI) for the tamoxifen treatment ratio falls within 0.7 to 1.43, olaparib can be considered to have had an effect on tamoxifen exposure that is unlikely to be clinically relevant.|GLS Mean Ratio|1.13|||||TWO_SIDED|90.0|1.06|1.22|||||olaparib + tamoxifen vs. tamoxifen|Analysis of tamoxifen PK parameters.||1.22|1.06|
72377576|NCT02093351|144264234|EQUIVALENCE|If the 90% CI for the olaparib treatment ratio falls within 0.7 to 1.43, tamoxifen can be considered to have had an effect on olaparib exposure that is unlikely to be clinically relevant.|GLS Mean Ratio|0.8|||||TWO_SIDED|90.0|0.71|0.9|||||olaparib + tamoxifen vs. olaparib|Analysis of olaparib PK parameters.||0.90|0.71|
72377577|NCT02093351|144264235|EQUIVALENCE|If the 90% CI for the anastrozole treatment ratio falls within 0.8 to 1.25, olaparib can be considered to have had little or no effect on anastrozole exposure.|Geometric Least Squares (GLS) Mean Ratio|0.9|||||TWO_SIDED|90.0|0.84|0.97|||||olaparib + anastrozole vs. anastrozole|Analysis of anastrozole PK parameters.||0.97|0.84|
72377578|NCT02093351|144264236|EQUIVALENCE|If the 90% CI for the olaparib treatment ratio falls within 0.7 to 1.43, anastrozole can be considered to have had an effect on olaparib exposure that is unlikely to be clinically relevant.|GLS Mean Ratio|0.94|||||TWO_SIDED|90.0|0.84|1.04|||||olaparib + anastrozole vs. olaparib|Analysis of olaparib PK parameters.||1.04|0.84|
72377579|NCT02093351|144264237|EQUIVALENCE|If the 90% CI for the letrozole treatment ratio falls within 0.8 to 1.25, olaparib can be considered to have had little or no effect on letrozole exposure.|GLS Mean Ratio|0.94|||||TWO_SIDED|90.0|0.91|0.98|||||olaparib + letrozole vs. letrozole|Analysis of letrozole PK parameters.||0.98|0.91|
72377580|NCT02093351|144264238|EQUIVALENCE|If the 90% CI for the olaparib treatment ratio falls within 0.7 to 1.43, letrozole can be considered to have had an effect on olaparib exposure that is unlikely to be clinically relevant.|GLS Mean Ratio|1.09|||||TWO_SIDED|90.0|0.99|1.21|||||olaparib + letrozole vs. olaparib|Analysis of olaparib PK parameters||1.21|0.99|
72377581|NCT02093351|144264239|EQUIVALENCE|If the 90% CI for the tamoxifen treatment ratio falls within 0.7 to 1.43, olaparib can be considered to have had an effect on tamoxifen exposure that is unlikely to be clinically relevant.|GLS Mean Ratio|1.16|||||TWO_SIDED|90.0|1.11|1.21|||||olaparib + tamoxifen vs. tamoxifen|Analysis of tamoxifen PK parameters.||1.21|1.11|
72377582|NCT02093351|144264240|EQUIVALENCE|If the 90% CI for the olaparib treatment ratio falls within 0.7 to 1.43, tamoxifen can be considered to have had an effect on olaparib exposure that is unlikely to be clinically relevant.|GLS Mean Ratio|0.73|||||TWO_SIDED|90.0|0.63|0.84|||||olaparib + tamoxifen vs. olaparib|Analysis of olaparib PK parameters.||0.84|0.63|
72377583|NCT02093351|144264241|EQUIVALENCE|If the 90% CI for the anastrozole treatment ratio falls within 0.8 to 1.25, olaparib can be considered to have had little or no effect on anastrozole exposure.|GLS Mean Ratio|0.86|||||TWO_SIDED|90.0|0.8|0.93|||||olaparib + anastrozole vs. anastrozole|Analysis of anastrozole PK parameters.||0.93|0.80|
72377584|NCT02093351|144264242|EQUIVALENCE|If the 90% CI for the olaparib treatment ratio falls within 0.7 to 1.43, anastrozole can be considered to have had an effect on olaparib exposure that is unlikely to be clinically relevant.|GLS Mean Ratio|0.89|||||TWO_SIDED|90.0|0.76|1.05|||||olaparib + anastrozole vs. olaparib|Analysis of olaparib PK parameters.||1.05|0.76|
72377585|NCT02093351|144264243|EQUIVALENCE|If the 90% CI for the letrozole treatment ratio falls within 0.8 to 1.25, olaparib can be considered to have had little or no effect on letrozole exposure.|GLS Mean Ratio|0.95|||||TWO_SIDED|90.0|0.91|0.99|||||olaparib + letrozole vs. letrozole|Analysis of letrozole PK parameters.||0.99|0.91|
72377586|NCT02093351|144264244|EQUIVALENCE|If the 90% CI for the olaparib treatment ratio falls within 0.7 to 1.43, letrozole can be considered to have had an effect on olaparib exposure that is unlikely to be clinically relevant.|GLS Mean Ratio|1.15|||||TWO_SIDED|90.0|1.07|1.25|||||olaparib + letrozole vs. olaparib|Analysis of olaparib PK parameters.||1.25|1.07|
72377587|NCT02446743|144264245|OTHER|Vaccine comparison at Persistence at 4/7.5 years/Baseline in V72\_75 \[(Group 3B (V72\_41) vs. Group B\_0\_1 (V72\_41)\]|Vaccine Group Difference|77.0|||||TWO_SIDED|95.0|68.1|84.1|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis group B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||84.1|68.1|
72377588|NCT02446743|144264245|OTHER|Vaccine comparison at Persistence at 4/7.5 years/Baseline in V72\_75 \[Group 3B (V72P10) vs. Group B\_0\_1 (V72P10)\]|Vaccine group difference|60.0|||||TWO_SIDED|95.0|49.9|69.2|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis group B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||69.2|49.9|
72377589|NCT02446743|144264245|OTHER|Vaccine comparison at Persistence at 4/7.5 years/Baseline in V72\_75 (Group 3B vs. Group B\_0\_1)|Vaccine group difference|68.0|||||TWO_SIDED|95.0|60.5|73.5|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis group B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||73.5|60.5|
72618425|NCT01623752|144767808|OTHER|||||||0.849|||||||ANOVA|||Statistical analysis (P value) composite for all categories.||||0.849
72618426|NCT05529173|144767875|OTHER||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
72377590|NCT02446743|144264245|OTHER|Vaccine comparison at Persistence at 4/7.5 years/Baseline in V72\_75 \[Group 3B (V72\_41) vs. Group B\_0\_1 (V72\_41)\]|Vaccine group difference|9.0|||||TWO_SIDED|95.0|5.3|14.8|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis group B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||14.8|5.3|
72377591|NCT02446743|144264245|OTHER|Vaccine comparison at Persistence at 4/7.5 years/Baseline in V72\_75 \[Group 3B (V72P10 vs. Group B\_0\_1 (V72P10)\]|Vaccine group difference|14.0|||||TWO_SIDED|95.0|4.9|24.2|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis group B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||24.2|4.9|
72377592|NCT02446743|144264245|OTHER|Vaccine comparison at Persistence at 4/7.5 years/Baseline in V72\_75 (Group 3B vs. Group B\_0\_1)|Vaccine group difference|10.0|||||TWO_SIDED|95.0|4.3|15.9|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis group B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||15.9|4.3|
72377593|NCT02446743|144264246|OTHER|Vaccine comparison at Persistence at 4/7.5 years/Baseline in V72\_75 (Group 3B vs. Group B\_0\_1)|vaccine group difference|25.0|||||TWO_SIDED|95.0|18.2|31.4|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis group B indicator strain H44/76and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||31.4|18.2|
72377594|NCT02446743|144264246|OTHER|Vaccine comparison at Persistence at 4/7.5 years/Baseline in V72\_75 \[(Group 3B (V72\_41) vs. Group B\_0\_1 (V72\_41)\]|Vaccine groups difference|22.0|||||TWO_SIDED|95.0|13.2|30.1|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis group B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||30.1|13.2|
72377595|NCT02446743|144264246|OTHER|Vaccine comparison at Persistence at 4/7.5 years/Baseline in V72\_75 \[Group 3B (V72P10) vs. Group B\_0\_1 (V72P10)\]|Vaccine group difference|30.0|||||TWO_SIDED|95.0|20.0|39.6|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis group B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||39.6|20.0|
72377596|NCT02446743|144264246|OTHER|Vaccine comparison at Persistence at 4/7.5 years/Baseline in V72\_75 (Group 3B vs. Group B\_0\_1)|Vaccine group difference|4.0|||||TWO_SIDED|95.0|-3.4|11.9|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis group B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||11.9|-3.4|
72377597|NCT02446743|144264246|OTHER|Vaccine comparison at Persistence at 4/7.5 years/Baseline in V72\_75 \[Group 3B (V72\_41) vs. Group B\_0\_1(V72\_41)\]|vaccine group differences|12.0|||||TWO_SIDED|95.0|0.33|24.2|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis group B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||24.2|0.33|
72377598|NCT02446743|144264246|OTHER|Vaccine comparison at Persistence at 4/7.5 years/Baseline in V72\_75 \[Group 3B (V72P10) vs. Group B\_0\_1(V72P10)\]|Vaccine group difference|0.0|||||TWO_SIDED|95.0|-10.0|9.5|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis group B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||9.5|-10.0|
72377599|NCT02446743|144264248|OTHER|Vaccine comparison at Persistence at 4/7.5 years/Baseline in V72\_75 (Group 3B vs. Group B\_0\_1)|Vaccine group difference|22.0|||||TWO_SIDED|95.0|16.5|28.6|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis group B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||28.6|16.5|
72556217|NCT02450539|144643566|SUPERIORITY||Hazard Ratio (HR)|1.333||||0.1746|TWO_SIDED|95.0|0.879|2.022|||Stratified log-rank test||Stratified Cox proportional hazard model|Stratified by baseline ECOG performance status (0 vs 1), number of Prior Therapies (received only platinum-based therapy vs Received platinum-based Therapy plus Immune Checkpoint Inhibitor), and time since initiation of first line therapy (\<=9 months vs \>9 months).\]||2.022|0.879|0.1746
72377600|NCT02446743|144264248|OTHER|Vaccine comparison at Persistence at 4/7.5 years/Baseline in V72\_75 \[Group 3B (V72\_41) vs. Group B\_0\_1 (V72\_41)\]|Vaccine group difference|21.0|||||TWO_SIDED|95.0|14.6|28.9|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis group B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||28.9|14.6|
72377601|NCT02446743|144264248|OTHER|Vaccine comparison at Persistence at 4/7.5 years/Baseline in V72\_75 \[Group 3B (V72P10) vs. Group B\_0\_1 (V72P10)\]|Vaccine group difference|26.0|||||TWO_SIDED|95.0|16.4|35.3|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis group B indicator strain H44/76and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||35.3|16.4|
72377602|NCT02446743|144264248|OTHER|Vaccine comparison at Persistence at 4/7.5 years/Baseline in V72\_75 (Group 3B vs. Group B\_0\_1)|Vaccine group difference|68.0|||||TWO_SIDED|95.0|60.8|73.7|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis group B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||73.7|60.8|
72377603|NCT02446743|144264248|OTHER|Vaccine comparison at Persistence at 4/7.5 years/Baseline in V72\_75 \[Group 3B (V72\_41) vs. Group B\_0\_1 (V72\_41)\]|Vaccine group difference|74.0|||||TWO_SIDED|95.0|65.3|81.3|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis group B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||81.3|65.3|
72556218|NCT02450539|144643567|SUPERIORITY||Rate Difference|-17.9|||||TWO_SIDED|95.0|-29.3|-6.6|||||Confidence intervals are based on the normal approximation to the binomial.|||-6.6|-29.3|
72618427|NCT02046200|144767930|SUPERIORITY_OR_OTHER|||||||0.0563|||||||ANOVA|||||||0.0563
72377604|NCT02446743|144264248|OTHER|Vaccine comparison at Persistence at 4/7.5 years/Baseline in V72\_75 \[Group 3B (V72P10) vs. Group B\_0\_1 (V72P10)\]|Vaccine group difference|64.0|||||TWO_SIDED|95.0|53.6|72.3|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis group B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||72.3|53.6|
72377605|NCT02446743|144264248|OTHER|Vaccine comparison at Persistence at 4/7.5 years/Baseline in V72\_75 (Group 3B vs. Group B\_0\_1)|Vaccine group difference|9.0|||||TWO_SIDED|95.0|3.7|14.0|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis group B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||14.0|3.7|
72377606|NCT02446743|144264248|OTHER|Vaccine comparison at Persistence at 4/7.5 years/Baseline in V72\_75 \[Group 3B (V72\_41) vs. Group B\_0\_1 (V72\_41)\]|Vaccine group difference|7.0|||||TWO_SIDED|95.0|3.3|12.3|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis group B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||12.3|3.3|
72377607|NCT02446743|144264248|OTHER|Vaccine comparison at Persistence at 4/7.5 years/Baseline in V72\_75 \[Group 3B (V72P10) vs. Group B\_0\_1 (V72P10)\]|Vaccine group difference|13.0|||||TWO_SIDED|95.0|4.5|22.0|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis group B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||22.0|4.5|
72377608|NCT02446743|144264248|OTHER|Vaccine comparison at Persistence at 4/7.5 years/Baseline in V72\_75 (Group 3B vs. Group B\_0\_1)|Vaccine group difference|5.0|||||TWO_SIDED|95.0|-3.4|12.8|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis group B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||12.8|-3.4|
72377609|NCT02446743|144264248|OTHER|Vaccine comparison at Persistence at 4/7.5 years/Baseline in V72\_75 \[Group 3B (V72\_41) vs. Group B\_0\_1 (V72\_41)\]|Vaccine group difference|9.0|||||TWO_SIDED|95.0|-3.3|21.4|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis group B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||21.4|-3.3|
72377610|NCT02446743|144264248|OTHER|Vaccine comparison at Persistence at 4/7.5 years/Baseline in V72\_75 \[Group 3B (V72P10) vs. Group B\_0\_1 (V72P10)\]|Vaccine group difference|4.0|||||TWO_SIDED|95.0|-6.4|14.5|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis group B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||14.5|-6.4|
72377611|NCT02446743|144264249|OTHER|Vaccine comparison at Persistence at 4/7.5 years/Baseline in V72\_75 (Group 3B vs. Group B\_0\_1)|Vaccine group difference|15.0|||||TWO_SIDED|95.0|10.1|20.9|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||20.9|10.1|
72377612|NCT02446743|144264249|OTHER|Vaccine comparison at Persistence at 4/7.5 years/Baseline in V72\_75 \[Group 3B (V72\_41) vs. Group B\_0\_1 (V72\_41)\]|Vaccine group difference|12.0|||||TWO_SIDED|95.0|7.5|18.1|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||18.1|7.5|
72377613|NCT02446743|144264249|OTHER|Vaccine comparison at Persistence at 4/7.5 years/Baseline in V72\_75 \[Group 3B (V72P10) vs. Group B\_0\_1 (V72P10)\]|Vaccine group difference|21.0|||||TWO_SIDED|95.0|12.3|29.9|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||29.9|12.3|
72377614|NCT02446743|144264249|OTHER|Vaccine comparison at Persistence at 4/7.5 years/Baseline in V72\_75 (Group 3B vs. Group B\_0\_1)|vaccine group difference|66.0|||||TWO_SIDED|95.0|59.6|72.4|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||72.4|59.6|
72377615|NCT02446743|144264249|OTHER|Vaccine comparison at Persistence at 4/7.5 years/Baseline in V72\_75 \[Group 3B (V72\_41) vs. Group B\_0\_1 (V72\_41)\]|Vaccine group difference|70.0|||||TWO_SIDED|95.0|60.8|77.0|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||77.0|60.8|
72377616|NCT02446743|144264249|OTHER|Vaccine comparison at Persistence at 4/7.5 years/Baseline in V72\_75 \[Group 3B (V72P10) vs. Group B\_0\_1 (V72P10)\]|Vaccine group difference|65.0|||||TWO_SIDED|95.0|55.2|73.7|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||73.7|55.2|
72377617|NCT02446743|144264249|OTHER|Vaccine comparison at Persistence at 4/7.5 years/Baseline in V72\_75 (Group 3B vs. Group B\_0\_1)|Vaccine group difference|9.0|||||TWO_SIDED|95.0|4.9|13.6|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||13.6|4.9|
72504985|NCT01462292|144541170|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.36||||0.417|TWO_SIDED|95.0|0.03|4.27||No adjustment for multiplicity was made, so p-values should not be used to make conclusions with regards to statistical significance|Regression, Logistic|Model includes terms for Treatment and Centre Grouping||Placebo (combined), GSK2402968 6 mg/kg/week||4.27|0.03|0.417
72504986|NCT02973815|144541176|OTHER||Mean Difference (Final Values)|-0.062|STANDARD_ERROR_OF_MEAN|0.065||0.342|TWO_SIDED|95.0|-0.194|0.067|||Regression, Linear|||This was adjusted for the baseline BMI-Z score, child sex, baseline child age, and economic assistance||0.067|-0.194|0.342
72618428|NCT02046200|144767931|SUPERIORITY_OR_OTHER|||||||0.0342|||||||ANOVA|||||||0.0342
72556219|NCT02450539|144643568|SUPERIORITY||Rate Difference|-13.2|||||TWO_SIDED|95.0|-29.2|2.8|||||Confidence intervals are based on the normal approximation to the binomial.|||2.8|-29.2|
72556220|NCT02450539|144643569|SUPERIORITY||Hazard Ratio (HR)|1.184||||0.7039|TWO_SIDED|95.0|0.502|2.792|||Stratified Log Rank||Stratified Cox regression model.|Stratification factors are baseline ECOG performance status (0 vs 1), Number of Prior Therapies (received only platinum-based therapy vs Received platinum-based Therapy plus Immune Checkpoint Inhibitor), and time since initiation of first line therapy (\<=9 months vs \>9 months).||2.792|0.502|0.7039
72556221|NCT02450539|144643570|SUPERIORITY||Mean Difference (Final Values)|0.18|STANDARD_ERROR_OF_MEAN|0.23|||TWO_SIDED|||||||||Headache||||
72556222|NCT02450539|144643570|SUPERIORITY||Mean Difference (Final Values)|0.86|STANDARD_ERROR_OF_MEAN|0.29|||TWO_SIDED|||||||||Diarrhea||||
72556223|NCT02450539|144643570|SUPERIORITY||Mean Difference (Final Values)|0.53|STANDARD_ERROR_OF_MEAN|0.22|||TWO_SIDED|||||||||Mean core symptom severity||||
72556224|NCT02450539|144643570|SUPERIORITY||Mean Difference (Final Values)|0.32|STANDARD_ERROR_OF_MEAN|0.34|||TWO_SIDED|||||||||Mean interference||||
72556225|NCT02450539|144643570|SUPERIORITY||Mean Difference (Final Values)|0.39|STANDARD_ERROR_OF_MEAN|0.19|||TWO_SIDED|||||||||Mean lung cancer symptom severity||||
72556226|NCT02450539|144643570|SUPERIORITY||Mean Difference (Final Values)|0.52|STANDARD_ERROR_OF_MEAN|0.21|||TWO_SIDED|||||||||Mean core plus lung cancer symptom severity||||
72556227|NCT02450539|144643570|SUPERIORITY||Mean Difference (Final Values)|0.06|STANDARD_ERROR_OF_MEAN|0.19|||TWO_SIDED|||||||||Mean brain tumor symptom severity||||
72556228|NCT02450539|144643570|SUPERIORITY||Mean Difference (Final Values)|0.69|STANDARD_ERROR_OF_MEAN|0.28|||TWO_SIDED|||||||||Mean core plus lung worst 5 symptoms severity||||
72556229|NCT02450539|144643570|SUPERIORITY||Mean Difference (Final Values)|0.09|STANDARD_ERROR_OF_MEAN|0.22|||TWO_SIDED|||||||||Rash||||
72556230|NCT02450539|144643571|SUPERIORITY||Mean Difference (Final Values)|-3.13|STANDARD_ERROR_OF_MEAN|2.07|||TWO_SIDED|||||||||EQ VAS Overall Self-rated Health Score||||
72556231|NCT02450539|144643572|SUPERIORITY||Median Difference (Final Values)|-0.04|STANDARD_ERROR_OF_MEAN|0.03|||TWO_SIDED|||||||||EQ-5D-5L Index Value||||
72556232|NCT02699463|144643573|SUPERIORITY||||||<|0.01||||||The calculated p-value was \<0.01|ANCOVA|||||||<0.01
72556233|NCT01108445|144643574|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.406||||0.157|TWO_SIDED||||||Log Rank|||||||0.157
72556234|NCT01108445|144643576|SUPERIORITY_OR_OTHER||Median PFS|5.6|||||TWO_SIDED||||||||The 95% CI for the HC was (4,6). If the median PFS for RAD001 is within the 95% CI for the HC, it is determined that there is not enough statistical evidence to say that the median PFS is different than the HC.|A comparison of the median PFS for RAD001 arm was compared to the 95% confidence interval(CI) of the median PFS of the historical control (HC). The null hypothesis was that there is no difference in the median PFS between the treatment arms and the historical control. If the median PFS is outside the 95%CI for the HC,it is determined there is statistical evidence that median PFS is different from the HC.||||
72556235|NCT01108445|144643576|SUPERIORITY_OR_OTHER||Median PFS|8.3|||||TWO_SIDED||||||||95% CI for HC was(4,6). If the median PFS for Sunitinib is within the 95% CI for the HC,it is determined that there is not enough statistical evidence to say that the median PFS is different than the HC.|A comparison of the median PFS for Sunitinib arm was compared to the 95% confidence interval(CI) of the median PFS of the historical control (HC). The null hypothesis was that there is no difference in the median PFS between the treatment arms and the historical control. If the median PFS is outside the 95%CI for the HC,it is determined there is statistical evidence that median PFS is different from the HC.||||
72556236|NCT01108445|144643578|SUPERIORITY_OR_OTHER|||||||0.589|TWO_SIDED||||||Chi-squared|||||||0.589
72556237|NCT01108445|144643579|SUPERIORITY_OR_OTHER|||||||0.066|TWO_SIDED||||||Chi-squared|||||||0.066
72556238|NCT04188392|144643591|OTHER|Rate of subjects enrolled per month of recruitment; based on 6 subjects enrolled over 5.8 months of recruitment.|Rate (per month)|1.03|||||TWO_SIDED|95.0|0.38|2.25|||||Based on 6 subjects enrolled over 5.8 months of recruitment|Recruitment goal of 6 subjects total.||2.25|0.38|
72556239|NCT04188392|144643592|OTHER|Total participants = 6; completed protocol: yes = 6, no = 0|Point estimate|1.0|||||TWO_SIDED|95.0|0.54|1.0|||||Point estimate = 100% (95% C.I. 54%,100%)|Binary outcome (completed protocol yes vs. no); goal of 75% of subjects completing protocol|Point estimate of completion rate and 95% confidence interval|1|0.54|
72556240|NCT04188392|144643593|OTHER|paired t-test|Mean of the differences|21.7||||0.2873|TWO_SIDED|95.0|-27.4|70.8||A priori significance threshold of p\<0.05|t-test, 2 sided|t=1.2263, df=4||alternative hypothesis: true difference in means is not equal to 0||70.8|-27.4|0.2873
72556241|NCT04188392|144643594|OTHER|Total participants = 6; discontinued due to adverse effects: yes = 0, no =6|Point estimate, 95% confidence interval|0.0|||||TWO_SIDED|95.0|0.0|0.46|||||Discontinuation rates due to adverse effects: Point estimate 0% (95% C.I. 0%, 45.9%)|Binary outcome: Discontinued due to adverse effects yes vs. no||0.46|0|
72556242|NCT04188392|144643595|OTHER|Total participants = 6; completed sleep study 1: yes = 6, no=0|point estimate|1.0|||||TWO_SIDED|95.0|0.54|1.0|||||Point estimate of completion rate for sleep study 1 = 100% (95% C.I. 54%, 100%)|Binary outcome: Completed sleep study 1 yes vs. no||1|0.54|
72556243|NCT04188392|144643595|OTHER|Total participants = 6; completed sleep study 2: yes = 6, no=0|point estimate|1.0|||||TWO_SIDED|95.0|0.54|1.0|||||Point estimate of completion rate for sleep study 2 = 100% (95% C.I. 54%, 100%)|Binary outcome: completed sleep study 2 yes vs. no||1|0.54|
72556244|NCT04188392|144643595|OTHER|Total participants = 6; completed sleep study 3: yes = 5, no=1|point estimate|0.83|||||TWO_SIDED|95.0|0.36|0.996|||||Point estimate of completion rate for sleep study 3 = 83.3% (95% C.I. 36%, 99.6%)|Binary outcome: completed sleep study 3 yes vs. no||0.996|0.36|
72556245|NCT04188392|144643595|OTHER|Total participants = 6; at least 4 days of actigraphy data: yes = 6, no=0|point estimate|1.0|||||TWO_SIDED|95.0|0.54|1.0|||||Point estimate of completion rate for at least 4 days of actigraphy pre-treatment = 100% (95% C.I. 54%, 100%).|Binary outcome: at least 4 days of actigraphy data pre-treatment yes vs. no||1|0.54|
72556246|NCT04188392|144643595|OTHER|Total participants = 6; at least 4 days of actigraphy post-treatment: yes = 6, no =0|point estimate|1.0|||||TWO_SIDED|95.0|0.54|1.0|||||Point estimate of at least 4 days of actigraphy post-treatment = 100% (95% C.I. 54%, 100%)|Binary outcome: at least 4 days of actigraphy post-treatment yes vs. no||1|0.54|
72556247|NCT04188392|144643595|OTHER|Total participants = 6; at least 4 days of sleep diary pre-treatment: yes = 6, no = 0|point estimate|1.0|||||TWO_SIDED|95.0|0.54|1.0|||||Point estimate of at least 4 days of sleep diary pre-treatment = 100% (95% C.I. 54%, 100%)|Binary outcome: at least 4 days of sleep diary pre-treatment yes vs. no||1|0.54|
72618429|NCT02046200|144767932|SUPERIORITY_OR_OTHER|||||||0.1597|||||||ANOVA|||||||0.1597
72377618|NCT02446743|144264249|OTHER|Vaccine comparison at Persistence at 4/7.5 years/Baseline in V72\_75 \[Group 3B (V72\_41) vs. Group B\_0\_1 (V72\_41)\]|Vaccine group difference|5.0|||||TWO_SIDED|95.0|1.2|9.7|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||9.7|1.2|
72377619|NCT02446743|144264249|OTHER|Vaccine comparison at Persistence at 4/7.5 years/Baseline in V72\_75 \[Group 3B (V72P10) vs. Group B\_0\_1 (V72P10)\]|Vaccine group difference|15.0|||||TWO_SIDED|95.0|7.5|22.6|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||22.6|7.5|
72377620|NCT02446743|144264249|OTHER|Vaccine comparison at Persistence at 4/7.5 years/Baseline in V72\_75 (Group 3B vs. Group B\_0\_1)|Vaccine group difference|2.0|||||TWO_SIDED|95.0|-6.8|10.0|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||10.0|-6.8|
72377621|NCT02446743|144264249|OTHER|Vaccine comparison at Persistence at 4/7.5 years/Baseline in V72\_75 \[Group 3B (V72\_41) vs. Group B\_0\_1 (V72\_41)\]|Vaccine group difference|3.0|||||TWO_SIDED|95.0|-9.8|15.2|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||15.2|-9.8|
72377622|NCT02446743|144264249|OTHER|Vaccine comparison at Persistence at 4/7.5 years/Baseline in V72\_75 \[Group 3B (V72P10) vs. Group B\_0\_1 (V72P10)\]|Vaccine group difference|4.0|||||TWO_SIDED|95.0|-7.8|14.7|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||14.7|-7.8|
72377623|NCT02446743|144264250|OTHER|Vaccine Comparison at Persistence at 4 years/Baseline in V72\_75 (Group 3B vs. Group B\_0\_1)|vaccine group ratio of GMTs|2.54|||||TWO_SIDED|95.0|2.07|3.12|||ANOVA|Adjusted by vaccine group and country||Adjusted geometric mean titers for H44/76 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country.||3.12|2.07|
72377624|NCT02446743|144264250|OTHER|Vaccine Comparison at Persistence at 4 years/Baseline in V72\_75 \[Group 3B (V72\_41) vs. Group B\_0\_1 (V72\_41)\]|vaccine group ratio of GMTs|2.13|||||TWO_SIDED|95.0|1.66|2.72|||ANOVA|Adjusted by vaccine group and country||Adjusted geometric mean titers for H44/76 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country.||2.72|1.66|
72377625|NCT02446743|144264250|OTHER|Vaccine Comparison at Persistence at 4 years/Baseline in V72\_75 \[Group 3B (V72P10) vs. Group B\_0\_1 (V72P10)\]|vaccine group ratio of GMTs|2.96|||||TWO_SIDED|95.0|2.15|4.07|||ANOVA|Adjusted by vaccine group and country||Adjusted geometric mean titers for H44/76 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country.||4.07|2.15|
72377626|NCT02446743|144264250|OTHER|Vaccine Comparison at Persistence at 4 years/Baseline in V72\_75 (Group 3B vs. Group B\_0\_1)|Vaccine group ratio of GMTs|16.0|||||TWO_SIDED|95.0|12.0|21.0|||ANOVA|Adjusted by vaccine group and country||Adjusted geometric mean titers for 5/99 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country.||21|12|
72377627|NCT02446743|144264250|OTHER|Vaccine Comparison at Persistence at 4 years/Baseline in V72\_75 \[Group 3B (V72\_41) vs. Group B\_0\_1 (V72\_41)\]|vaccine group ratio of GMTs|20.0|||||TWO_SIDED|95.0|14.0|28.0|||ANOVA|Adjusted by vaccine group and country||Adjusted geometric mean titers for 5/99 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country.||28|14|
72377628|NCT02446743|144264250|OTHER|Vaccine Comparison at Persistence at 4 years/Baseline in V72\_75 \[Group 3B (V72P10) vs. Group B\_0\_1 (V72P10)\]|vaccine group ratio of GMTs|14.0|||||TWO_SIDED|95.0|9.05|20.0|||ANOVA|Adjusted by vaccine group and country||Adjusted geometric mean titers for 5/99 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country.||20|9.05|
72377629|NCT02446743|144264250|OTHER|Vaccine Comparison at Persistence at 4 years/Baseline in V72\_75 (Group 3B vs. Group B\_0\_1)|Vaccine group ratio of GMTs|1.5|||||TWO_SIDED|95.0|1.26|1.78|||ANOVA|Adjusted by vaccine group and country||Adjusted geometric mean titers for NZ98/254 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country||1.78|1.26|
72377630|NCT02446743|144264250|OTHER|Vaccine Comparison at Persistence at 4 years/Baseline in V72\_75 \[Group 3B (V72\_41) vs. Group B\_0\_1 (V72\_41)\]|vaccine group ratio of GMTs|1.3|||||TWO_SIDED|95.0|1.11|1.51|||ANOVA|Adjusted by vaccine group and country||Adjusted geometric mean titers for NZ98/254 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country||1.51|1.11|
72504987|NCT02973815|144541177|OTHER||Mean Difference (Net)|1.25|STANDARD_ERROR_OF_MEAN|0.73104||0.09|TWO_SIDED|95.0|-0.2|2.71|||Regression, Linear|||Adjusted for: baseline HFI Fruit value, and economic assistance status||2.71|-0.20|0.09
72504988|NCT02973815|144541178|OTHER||Mean Difference (Net)|1.23|STANDARD_ERROR_OF_MEAN|0.61||0.047|TWO_SIDED|95.0|0.02|2.44|||Regression, Linear|||Adjusted for: baseline HFI Vegetable value, and economic assistance status||2.44|0.02|0.047
72504989|NCT02973815|144541179|OTHER||Mean Difference (Net)|0.48|STANDARD_ERROR_OF_MEAN|0.2||0.019|TWO_SIDED|95.0|0.08|0.88|||Regression, Linear|||Adjusted for: baseline healthfulness score and economic assistance status||0.88|0.08|0.019
72377631|NCT02446743|144264250|OTHER|Vaccine Comparison at Persistence at 4 years/Baseline in V72\_75 \[Group 3B (V72P10) vs. Group B\_0\_1 (V72P10)\]|vaccine group ratio of GMTs|1.7|||||TWO_SIDED|95.0|1.27|2.28|||ANOVA|Adjusted by vaccine group and country||Adjusted geometric mean titers for NZ98/254 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country||2.28|1.27|
72377632|NCT02446743|144264250|OTHER|Vaccine Comparison at Persistence at 4 years/Baseline in V72\_75 (Group 3B vs. Group B\_0\_1)|Vaccine group ratio of GMTs|1.26|||||TWO_SIDED|95.0|0.94|1.68|||ANOVA|Adjusted by vaccine group and country||Adjusted geometric mean titers for M10713 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country||1.68|0.94|
72377633|NCT02446743|144264250|OTHER|Vaccine Comparison at Persistence at 4 years/Baseline in V72\_75 \[Group 3B (V72\_41) vs. Group B\_0\_1 (V72\_41)\]|vaccine group ratio of GMTs|1.32|||||TWO_SIDED|95.0|0.85|2.05|||ANOVA|Adjusted by vaccine group and country||Adjusted geometric mean titers for M10713 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country||2.05|0.85|
72377634|NCT02446743|144264250|OTHER|Vaccine Comparison at Persistence at 4 years/Baseline in V72\_75 \[Group 3B (V72P10) vs. Group B\_0\_1 (V72P10)\]|vaccine group ratio of GMTs|1.2|||||TWO_SIDED|95.0|0.81|1.78|||ANOVA|Adjusted by vaccine group and country||Adjusted geometric mean titers for M10713 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country||1.78|0.81|
72377635|NCT02446743|144264255|OTHER|Vaccine comparison at 1 month after booster /1st dose in V72\_75 \[Group 3B (V72\_41) vs. Group B\_0\_1 (V72\_41)\]|Vaccine group difference|13.0|||||TWO_SIDED|95.0|8.0|21.6|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference were calculated using the method of Miettinen and Nurminen||21.6|8.0|
72377636|NCT02446743|144264255|OTHER|Vaccine comparison at 1 month after booster /1st dose in V72\_75 \[Group 3B (V72P10) vs. Group B\_0\_1 (V72P10)\]|Vaccine group difference|16.0|||||TWO_SIDED|95.0|10.8|23.1|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference were calculated using the method of Miettinen and Nurminen||23.1|10.8|
72377637|NCT02446743|144264255|OTHER|Vaccine comparison at 1 month after booster /1st dose in V72\_75 (Group 3B vs. Group B\_0\_1)|Vaccine group difference|15.0|||||TWO_SIDED|95.0|11.0|20.1|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference were calculated using the method of Miettinen and Nurminen||20.1|11.0|
72377638|NCT02446743|144264255|OTHER|Vaccine comparison at 1 month after booster /1st dose in V72\_75 \[Group 3B (V72\_41) vs. Group B\_0\_1 (V72\_41)\]|Vaccine group difference|54.0|||||TWO_SIDED|95.0|43.0|63.3|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference were calculated using the method of Miettinen and Nurminen||63.3|43.0|
72377639|NCT02446743|144264255|OTHER|Vaccine comparison at 1 month after booster /1st dose in V72\_75 \[Group 3B (V72P10) vs. Group B\_0\_1 (V72P10)\]|Vaccine group difference|31.0|||||TWO_SIDED|95.0|22.0|40.1|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference were calculated using the method of Miettinen and Nurminen||40.1|22.0|
72377640|NCT02446743|144264255|OTHER|Vaccine comparison at 1 month after booster /1st dose in V72\_75 (Group 3B vs. Group B\_0\_1)|Vaccine group difference|41.0|||||TWO_SIDED|95.0|33.6|47.2|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference were calculated using the method of Miettinen and Nurminen||47.2|33.6|
72377641|NCT02446743|144264256|OTHER|Vaccine comparison at 1 month after booster /1st dose in V72\_75 (Group 3B vs. Group B\_0\_1)|Vaccine group difference|20.0|||||TWO_SIDED|95.0|15.0|25.4|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference were calculated using the method of Miettinen and Nurminen||25.4|15.0|
72377642|NCT02446743|144264256|OTHER|Vaccine comparison at 1 month after booster /1st dose in V72\_75 \[Group 3B (V72\_41) vs. Group B\_0\_1 (V72\_41)\]|Vaccine group difference|18.0|||||TWO_SIDED|95.0|10.7|27.0|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference were calculated using the method of Miettinen and Nurminen||27.0|10.7|
72377643|NCT02446743|144264256|OTHER|Vaccine comparison at 1 month after booster /1st dose in V72\_75 \[Group 3B (V72P10) vs. Group B\_0\_1 (V72P10)\]|Vaccine group difference|21.0|||||TWO_SIDED|95.0|15.6|28.8|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference were calculated using the method of Miettinen and Nurminen||28.8|15.6|
72433597|NCT00991276|144380368|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|32.1|STANDARD_ERROR_OF_MEAN|4.18|<|0.0001|TWO_SIDED|95.0|23.83|40.36||This analysis was step 4 in a step-down procedure (if p-value \< 0.05, then continue to next step) used to control the Type I error rate.|Mixed Models Analysis|||Stage N3 sleep/SWS: P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||40.36|23.83|<0.0001
72504990|NCT02973815|144541180|OTHER||Mean Difference (Net)|-0.15|STANDARD_ERROR_OF_MEAN|0.12||0.218|TWO_SIDED|95.0|-0.4|0.09|||Regression, Linear|||Adjusted for: baseline vegetable intake, child age (baseline), parent education status (bachelors or higher vs lower)||0.09|-0.4|0.218
72377644|NCT02446743|144264256|OTHER|Vaccine comparison at 1 month after booster /1st dose in V72\_75 (Group 3B vs. Group B\_0\_1)|vaccine group difference|12.0|||||TWO_SIDED|95.0|8.0|16.8|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||16.8|8.0|
72377645|NCT02446743|144264256|OTHER|Vaccine comparison at 1 month after booster /1st dose in V72\_75 \[Group 3B (V72\_41) vs. Group B\_0\_1 (V72\_41)\]|Vaccine group difference|20.0|||||TWO_SIDED|95.0|12.8|28.6|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||28.6|12.8|
72377646|NCT02446743|144264256|OTHER|Vaccine comparison at 1 month after booster /1st dose in V72\_75 \[Group 3B (V72P10) vs. Group B\_0\_1 (V72P10)\]|Vaccine group difference|6.0|||||TWO_SIDED|95.0|1.5|12.2|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||12.2|1.5|
72377647|NCT02446743|144264257|OTHER|Vaccine comparison at 1 month after booster /1st dose in V72\_75 (Group 3B vs. Group B\_0\_1)|Vaccine group difference|27.0|||||TWO_SIDED|95.0|21.9|33.3|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference were calculated using the method of Miettinen and Nurminen||33.3|21.9|
72377648|NCT02446743|144264257|OTHER|Vaccine comparison at 1 month after booster /1st dose in V72\_75 \[Group 3B (V72\_41) vs. Group B\_0\_1 (V72\_41)\]|Vaccine group difference|31.0|||||TWO_SIDED|95.0|21.8|40.3|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference were calculated using the method of Miettinen and Nurminen||40.3|21.8|
72377649|NCT02446743|144264257|OTHER|Vaccine comparison at 1 month after booster /1st dose in V72\_75 \[Group 3B (V72P10) vs. Group B\_0\_1 (V72P10)\]|Vaccine group difference|26.0|||||TWO_SIDED|95.0|19.2|33.1|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference were calculated using the method of Miettinen and Nurminen||33.1|19.2|
72377650|NCT02446743|144264257|OTHER|Vaccine comparison at 1 month after booster /1st dose in V72\_75 (Group 3B vs. Group B\_0\_1)|vaccine group difference|19.0|||||TWO_SIDED|95.0|14.3|24.3|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference were calculated using the method of Miettinen and Nurminen||24.3|14.3|
72377651|NCT02446743|144264257|OTHER|Vaccine comparison at 1 month after booster /1st dose in V72\_75 \[Group 3B (V72\_41) vs. Group B\_0\_1 (V72\_41)\]|Vaccine group difference|19.0|||||TWO_SIDED|95.0|12.1|27.5|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference were calculated using the method of Miettinen and Nurminen||27.5|12.1|
72377652|NCT02446743|144264257|OTHER|Vaccine comparison at 1 month after booster /1st dose in V72\_75 \[Group 3B (V72P10) vs. Group B\_0\_1 (V72P10)\]|Vaccine group difference|19.0|||||TWO_SIDED|95.0|13.3|26.4|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference were calculated using the method of Miettinen and Nurminen||26.4|13.3|
72377653|NCT02446743|144264257|OTHER|Vaccine comparison at 1 month after booster /1st dose in V72\_75 (Group 3B vs. Group B\_0\_1)|vaccine group difference|43.0|||||TWO_SIDED|95.0|35.2|49.9|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference were calculated using the method of Miettinen and Nurminen||49.9|35.2|
72377654|NCT02446743|144264257|OTHER|Vaccine comparison at 1 month after booster /1st dose in V72\_75 \[Group 3B (V72\_41) vs. Group B\_0\_1 (V72\_41)\]|Vaccine group difference|58.0|||||TWO_SIDED|95.0|46.6|67.3|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference were calculated using the method of Miettinen and Nurminen||67.3|46.6|
72377655|NCT02446743|144264257|OTHER|Vaccine comparison at 1 month after booster /1st dose in V72\_75 \[Group 3B (V72P10) vs. Group B\_0\_1 (V72P10)\]|Vaccine group difference|33.0|||||TWO_SIDED|95.0|23.0|42.5|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference were calculated using the method of Miettinen and Nurminen||42.5|23.0|
72377656|NCT02446743|144264257|OTHER|Vaccine comparison at 1 month after booster /1st dose in V72\_75 (Group 3B vs. Group B\_0\_1)|vaccine group difference|13.0|||||TWO_SIDED|95.0|8.8|18.3|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference were calculated using the method of Miettinen and Nurminen||18.3|8.8|
72377657|NCT02446743|144264257|OTHER|Vaccine comparison at 1 month after booster /1st dose in V72\_75 \[Group 3B (V72\_41) vs. Group B\_0\_1 (V72\_41)\]|Vaccine group difference|20.0|||||TWO_SIDED|95.0|12.6|29.0|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference were calculated using the method of Miettinen and Nurminen||29.0|12.6|
72504991|NCT02973815|144541181|OTHER||Mean Difference (Net)|0.37|STANDARD_ERROR_OF_MEAN|0.2||0.066|TWO_SIDED|95.0|-0.03|0.77|||Regression, Linear|||Adjusted for: baseline fruit intake, child age (baseline), parent education status (bachelors or higher vs lower)||0.77|-0.03|0.066
72504992|NCT02973815|144541182|OTHER||Mean Difference (Net)|-4.79|STANDARD_ERROR_OF_MEAN|4.41||0.28|TWO_SIDED|95.0|-13.56|3.98|||Regression, Linear|||Adjusted for: baseline MVPA, child age (baseline), and child sex||3.98|-13.56|0.28
72504993|NCT02973815|144541183|OTHER||Mean Difference (Net)|0.01|STANDARD_ERROR_OF_MEAN|0.17||0.928|TWO_SIDED|95.0|-0.31|0.34|||Regression, Linear|||Adjusted for: baseline screentime, child age (baseline), and child sex||0.34|-0.31|0.928
72504994|NCT02342561|144541189|SUPERIORITY_OR_OTHER|||||||0.601|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||At end of surgery||||0.601
72504995|NCT02342561|144541189|SUPERIORITY_OR_OTHER|||||||0.823|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||After skin disinfection||||0.823
72504996|NCT02342561|144541190|SUPERIORITY_OR_OTHER|||||||0.731|TWO_SIDED||||||Fisher Exact|||Difference in prevalence of CoNs between the 2 groups was analysed. The null-hypothesis was no difference.||||0.731
72504997|NCT01145391|144541191|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence||||||0.5||95.0||||For systolic blood pressure|Mixed Models Analysis|||||||0.50
72504998|NCT03037905|144541217|SUPERIORITY||Mean Difference (Final Values)|-6.7||||0.2|TWO_SIDED|95.0|-17.1|3.7|||Mixed Models Analysis|||||3.7|-17.1|0.20
72504999|NCT03037905|144541218|SUPERIORITY||Mean Difference (Final Values)|2.2||||0.6|TWO_SIDED|95.0|-5.9|10.3|||Mixed Models Analysis|||||10.3|-5.9|0.60
72505000|NCT03037905|144541219|SUPERIORITY||Mean Difference (Final Values)|-1.0||||0.76|TWO_SIDED|95.0|-7.0|5.1|||Mixed Models Analysis|||||5.1|-7.0|.76
72505001|NCT03037905|144541220|SUPERIORITY|||||||0.83|||||||Wilcoxon (Mann-Whitney)|||||||.83
72505002|NCT02042131|144541252|SUPERIORITY|||||||0.082|||||||Log Rank|||Omnibus test of all three groups||||.082
72505003|NCT02042131|144541252|SUPERIORITY|||||||0.028|||||||Log Rank|||Planned contrast #1: TAU vs. S-CRP/E-CRP||||.028
72505004|NCT02042131|144541252|SUPERIORITY||Cox Proportional Hazard|0.24||||0.04|TWO_SIDED|95.0|0.06|0.96|||Regression, Cox|||Planned contrast #1: TAU vs. S-CRP/E-CRP||0.96|0.06|.040
72505005|NCT02042131|144541253|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||Omnibus test comparing all three groups.||||<0.001
72505006|NCT02042131|144541253|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||Planned contrast #1: TAU vs. S-CRP/E-CRP||||<0.001
72505007|NCT02042131|144541254|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||Planned contrast #1: TAU vs. S-CRP/E-CRP||||<0.001
72505008|NCT02042131|144541255|SUPERIORITY|||||||0.04|||||||Chi-squared|||Omnibus test of all groups||||0.040
72505009|NCT02042131|144541255|SUPERIORITY||Odds Ratio (OR)|0.1||||0.045|TWO_SIDED|95.0|0.002|0.9|||Chi-squared|||Planned contrast #2: E-CRP vs. TAU/S-CRP||0.9|0.002|0.045
72618430|NCT02046200|144767933|SUPERIORITY_OR_OTHER|||||||0.7617|||||||ANOVA|||||||0.7617
72505010|NCT00377299|144541290|SUPERIORITY_OR_OTHER|||||||0.05||95.0||||Significance was set at a p value of ≤ 0.05.|ANCOVA|||||||0.05
72618431|NCT02046200|144767934|SUPERIORITY_OR_OTHER|||||||0.93|||||||ANOVA|||||||0.93
72618432|NCT02046200|144767935|SUPERIORITY_OR_OTHER|||||||0.95|||||||ANOVA|||||||0.95
72505011|NCT00377299|144541291|SUPERIORITY_OR_OTHER||||||>|0.05||95.0||||Significance was set at a p value of ≤ 0.05.|ANCOVA|||||||>0.05
72505012|NCT00377299|144541292|SUPERIORITY_OR_OTHER||||||>|0.05||95.0||||Significance was set at a p value of ≤ 0.05.|ANCOVA|||||||>0.05
72505013|NCT00377299|144541293|SUPERIORITY_OR_OTHER||||||>|0.05||95.0||||Significance was set at a p value of ≤ 0.05.|ANCOVA|||||||>0.05
72505014|NCT00377299|144541294|SUPERIORITY_OR_OTHER||||||>|0.05||95.0||||Significance was set at a p value of ≤ 0.05.|ANCOVA|||||||>0.05
72505015|NCT03165981|144541295|SUPERIORITY||Risk Ratio (RR)|0.87||||0.7588|TWO_SIDED|95.0|0.36|2.1|||Mantel Haenszel|Mantel Haenzel is stratified by site.|RR is adjusted by site.|||2.10|0.36|0.7588
72505016|NCT03165981|144541296|SUPERIORITY||Risk Ratio (RR)|0.97||||0.9412|TWO_SIDED|95.0|0.39|2.4|||Mantel Haenszel|Mantel Haenzel is stratified by site.|RR is adjusted by site.|||2.40|0.39|.9412
72505017|NCT03165981|144541297|SUPERIORITY|||||||0.3408|||||||Mantel Haenszel|Mantel Haenzel is stratified by site.||||||0.3408
72505018|NCT03165981|144541298|SUPERIORITY||Risk Ratio (RR)|0.87||||0.8325|TWO_SIDED|95.0|0.24|3.13|||Mantel Haenszel|Mantel Haenzel is stratified by site.|RR is adjusted by site.|||3.13|0.24|0.8325
72505019|NCT03165981|144541299|SUPERIORITY|||||||0.3408|||||||Mantel Haenszel|Mantel Haenzel is stratified by site.||||||0.3408
72505020|NCT03165981|144541300|SUPERIORITY||Risk Ratio (RR)|0.73||||0.6101|TWO_SIDED|95.0|0.21|2.48|||Mantel Haenszel|Mantel Haenzel is stratified by site.|RR is adjusted by site.|||2.48|0.21|0.6101
72505021|NCT03165981|144541301|SUPERIORITY|||||||0.848|||||||Wilcoxon (Mann-Whitney)|||||||0.848
72505022|NCT03165981|144541303|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||||||1.000
72505023|NCT03952546|144541352|NON_INFERIORITY|The test for non-inferiority was carried out by calculating the upper 95% confidence limit (one sided confidence interval) for the difference in estimated blood loss (δ = Unipolar electrocautery system - Saline-coupled bipolar sealer), with the margin of inferiority (δ), set at 200 cc.||||||0.1254|||||||t-test, 1 sided|||||||0.1254
72505024|NCT03952546|144541353|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
72505025|NCT04315363|144541355|EQUIVALENCE|Two by two Mixed Analysis of Variance (ANOVA) models (i.e., within-subject effect: pre- and post- intervention \* between-subject effect: intervention and control group) were estimated to investigate the primary outcome changes (i.e., sedentary time) before and after the intervention.||||||0.8|||||||ANOVA|||||||0.8
72505026|NCT04315363|144541356|EQUIVALENCE|Two by two Mixed Analysis of Variance (ANOVA) models (i.e., within-subject effect: pre- and post- intervention \* between-subject effect: intervention and control group) were estimated to investigate the secondary outcome changes (i.e., moderate-to-vigorous physical activity) before and after the intervention.||||||0.35|||||||ANOVA|||||||0.35
72505027|NCT00641147|144541407|SUPERIORITY|||||||0.58|||||||t-test, 2 sided|||||||0.58
72505028|NCT00641147|144541407|SUPERIORITY|||||||0.57|||||||ANCOVA|||||||0.57
72505029|NCT00641147|144541408|SUPERIORITY|||||||0.76|||||||t-test, 2 sided|||||||0.76
72505030|NCT00641147|144541409|SUPERIORITY|||||||0.85|||||||Chi-squared|||||||0.85
72505031|NCT00641147|144541410|SUPERIORITY|||||||0.16|||||||Chi-squared|||||||0.16
72505032|NCT00641147|144541411|SUPERIORITY|||||||0.31|||||||Wilcoxon (Mann-Whitney)|||||||0.31
72505033|NCT00641147|144541412|SUPERIORITY|||||||0.63|||||||t-test, 2 sided|||||||0.63
72505034|NCT00641147|144541413|SUPERIORITY|||||||0.24|||||||t-test, 2 sided|||||||0.24
72505035|NCT00641147|144541414|SUPERIORITY|||||||0.63|||||||t-test, 2 sided|||||||0.63
72505036|NCT00641147|144541415|SUPERIORITY|||||||0.93|||||||t-test, 2 sided|||||||0.93
72505037|NCT00641147|144541416|SUPERIORITY|||||||0.41|||||||t-test, 2 sided|||||||0.41
72505038|NCT00641147|144541417|SUPERIORITY|||||||0.14|||||||t-test, 2 sided|||||||0.14
72505039|NCT00641147|144541418|SUPERIORITY|||||||0.09|||||||t-test, 2 sided|||||||0.09
72505040|NCT00641147|144541422|SUPERIORITY|||||||0.95|||||||Chi-squared|||||||0.95
72377658|NCT02446743|144264257|OTHER|Vaccine comparison at 1 month after booster /1st dose in V72\_75 \[Group 3B (V72P10) vs. Group B\_0\_1 (V72P10)\]|Vaccine group difference|8.0|||||TWO_SIDED|95.0|2.7|14.7|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference were calculated using the method of Miettinen and Nurminen||14.7|2.7|
72377659|NCT02446743|144264258|OTHER|Vaccine comparison at 1 month after booster /1st dose in V72\_75 (Group 3B vs. Group B\_0\_1)|vaccine group difference|40.0|||||TWO_SIDED|95.0|33.9|46.3|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||46.3|33.9|
72377660|NCT02446743|144264258|OTHER|Vaccine comparison at 1 month after booster /1st dose in V72\_75 \[Group 3B (V72\_41) vs. Group B\_0\_1 (V72\_41)\]|Vaccine group difference|49.0|||||TWO_SIDED|95.0|38.9|58.5|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||58.5|38.9|
72377661|NCT02446743|144264258|OTHER|Vaccine comparison at 1 month after booster /1st dose in V72\_75 \[Group 3B (V72P10) vs. Group B\_0\_1 (V72P10)\]|Vaccine group difference|34.0|||||TWO_SIDED|95.0|26.6|42.2|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||42.2|26.6|
72377662|NCT02446743|144264258|OTHER|Vaccine comparison at 1 month after booster /1st dose in V72\_75 (Group 3B vs. Group B\_0\_1)|vaccine group difference|27.0|||||TWO_SIDED|95.0|21.6|33.0|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||33.0|21.6|
72377663|NCT02446743|144264258|OTHER|Vaccine comparison at 1 month after booster /1st dose in V72\_75 \[Group 3B (V72\_41) vs. Group B\_0\_1 (V72\_41)\]|Vaccine group difference|23.0|||||TWO_SIDED|95.0|15.5|32.0|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||32.0|15.5|
72377664|NCT02446743|144264258|OTHER|Vaccine comparison at 1 month after booster /1st dose in V72\_75 \[Group 3B (V72P10) vs. Group B\_0\_1 (V72P10)\]|Vaccine group difference|30.0|||||TWO_SIDED|95.0|22.9|38.1|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||38.1|22.9|
72377665|NCT02446743|144264258|OTHER|Vaccine comparison at 1 month after booster /1st dose in V72\_75 (Group 3B vs. Group B\_0\_1)|vaccine group difference|43.0|||||TWO_SIDED|95.0|35.1|50.6|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||50.6|35.1|
72377666|NCT02446743|144264258|OTHER|Vaccine comparison at 1 month after booster /1st dose in V72\_75 \[Group 3B (V72\_41) vs. Group B\_0\_1 (V72\_41)\]|Vaccine group difference|51.0|||||TWO_SIDED|95.0|39.3|60.9|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||60.9|39.3|
72377667|NCT02446743|144264258|OTHER|Vaccine comparison at 1 month after booster /1st dose in V72\_75 \[Group 3B (V72P10) vs. Group B\_0\_1 (V72P10)\]|Vaccine group difference|41.0|||||TWO_SIDED|95.0|29.9|50.2|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||50.2|29.9|
72377668|NCT02446743|144264258|OTHER|Vaccine comparison at 1 month after booster /1st dose in V72\_75 (Group 3B vs. Group B\_0\_1)|vaccine group difference|19.0|||||TWO_SIDED|95.0|12.9|24.6|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||24.6|12.9|
72556248|NCT04188392|144643595|OTHER|Total participants = 6; at least 4 days of sleep diary post-treatment: yes = 6, no = 0|point estimate|1.0|||||TWO_SIDED|95.0|0.54|1.0|||||Point estimate of at least 4 days of sleep diary post-treatment = 100% (95% C.I. 54%, 100%)|Binary outcome: at least 4 days of sleep diary post-treatment yes vs. no||1|0.54|
72377669|NCT02446743|144264258|OTHER|Vaccine comparison at 1 month after booster /1st dose in V72\_75 \[Group 3B (V72\_41) vs. Group B\_0\_1 (V72\_41)\]|Vaccine group difference|28.0|||||TWO_SIDED|95.0|17.9|37.8|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||37.8|17.9|
72377670|NCT02446743|144264258|OTHER|Vaccine comparison at 1 month after booster /1st dose in V72\_75 \[Group 3B (V72P10) vs. Group B\_0\_1 (V72P10)\]|Vaccine group difference|13.0|||||TWO_SIDED|95.0|6.4|20.1|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||20.1|6.4|
72377671|NCT02446743|144264259|OTHER|"Vaccine comparison Pre-booster or pre-1st dose in V72\_75 (Group 3B vs. Group B~\_0\_1)"|Ratio of GMTs|2.6|||||TWO_SIDED|95.0|2.11|3.2|||ANOVA|||Pre booster/Pre first dose-Adjusted geometric mean titers for H44/76 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country.||3.20|2.11|
72556249|NCT00835692|144643616|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The pharmacokinetic parameters will be evaluated statistically by an analysis of variance (ANOVA) appropriate for the experimental design of this study.|Test/Ref Ratio of LS Mean x 100|98.4||||||90.0|91.5|106.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||106|91.5|
72377672|NCT02446743|144264259|OTHER|"Vaccine comparison Post-booster or post-1st dose in V72\_75 (Group 3B vs. Group B~\_0\_1)"|Ratio of GMTs|11.0|||||TWO_SIDED|95.0|8.85|15.0|||ANOVA|||Post booster/Post first dose-Adjusted geometric mean titers for H44/76 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country||15|8.85|
72377673|NCT02446743|144264259|OTHER|Vaccine comparison-Pre-booster or pre-1st dose in V72\_75 \[Group 3B (V72\_41) vs. Group B\_0\_1 (V72\_41)\]|Ratio of GMTs|2.18|||||TWO_SIDED|95.0|1.7|2.79|||ANOVA|||Pre booster/Pre first dose-Adjusted geometric mean titers for H44/76 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country.||2.79|1.70|
72377674|NCT02446743|144264259|OTHER|Vaccine comparison-post-booster or post-1st dose in V72\_75 \[Group 3B (V72\_41) vs. Group B\_0\_1 (V72\_41)\]|Ratio of GMTs|12.0|||||TWO_SIDED|95.0|8.22|17.0|||ANOVA|||Post booster/Post first dose-Adjusted geometric mean titers for H44/76 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country||17|8.22|
72377675|NCT02446743|144264259|OTHER|Vaccine comparison- Pre-booster or pre-1st dose in V72\_75 \[Group 3B (V72P10) vs. Group B\_0\_1 (V72P10)\]|Ratio of GMTs|3.04|||||TWO_SIDED|95.0|2.2|4.2|||ANOVA|||Pre booster/Pre first dose-Adjusted geometric mean titers for H44/76 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country.||4.20|2.20|
72377676|NCT02446743|144264259|OTHER|Vaccine comparison- post-booster or post-1st dose in V72\_75 \[Group 3B (V72P10) vs. Group B\_0\_1 (V72P10)\]|Ratio of GMTs|11.0|||||TWO_SIDED|95.0|7.75|16.0|||ANOVA|||Post booster/Post first dose-Adjusted geometric mean titers for H44/76 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country||16|7.75|
72377677|NCT02446743|144264259|OTHER|"Vaccine comparison Pre-booster or pre-1st dose in V72\_75 (Group 3B vs. Group B~\_0\_1)"|Ratio of GMTs|16.0|||||TWO_SIDED|95.0|12.0|21.0|||ANOVA|||Pre booster/Pre first dose-Adjusted geometric mean titers for 5/99 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country||21|12|
72377678|NCT02446743|144264259|OTHER|"Vaccine comparison Post-booster or post-1st dose in V72\_75 (Group 3B vs. Group B~\_0\_1)"|Ratio of GMTs|68.0|||||TWO_SIDED|95.0|51.0|90.0|||ANOVA|||Post booster/Post first dose-Adjusted geometric mean titers for 5/99 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country||90|51|
72377679|NCT02446743|144264259|OTHER|Vaccine comparison- Pre-booster or pre-1st dose in V72\_75 \[Group 3B (V72\_41) vs. Group B\_0\_1 (V72\_41)\]|Ratio of GMTs|18.0|||||TWO_SIDED|95.0|13.0|26.0|||ANOVA|||Pre booster/Pre first dose-Adjusted geometric mean titers for 5/99 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country.||26|13|
72377680|NCT02446743|144264259|OTHER|Vaccine comparison- post-booster or post-1st dose in V72\_75 \[Group 3B (V72\_41) vs. Group B\_0\_1 (V72\_41)\]|Ratio of GMTs|74.0|||||TWO_SIDED|95.0|51.0|107.0|||ANOVA|||Post booster/Post first dose-Adjusted geometric mean titers for 5/99 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country||107|51|
72377681|NCT02446743|144264259|OTHER|Vaccine comparison- Pre-booster or pre-1st dose in V72\_75 \[Group 3B (V72P10) vs. Group B\_0\_1 (V72P10)\]|Ratio of GMTs|14.0|||||TWO_SIDED|95.0|8.99|22.0|||ANOVA|||Pre booster/Pre first dose-Adjusted geometric mean titers for 5/99 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country.||22|8.99|
72377682|NCT02446743|144264259|OTHER|Vaccine comparison- post-booster or post-1st dose in V72\_75 \[Group 3B (V72P10) vs. Group B\_0\_1 (V72P10)\]|Ratio of GMTs|63.0|||||TWO_SIDED|95.0|41.0|95.0|||ANOVA|||Post booster/Post first dose-Adjusted geometric mean titers for 5/99 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country||95|41|
72556250|NCT00835692|144643617|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The pharmacokinetic parameters will be evaluated statistically by an analysis of variance (ANOVA) appropriate for the experimental design of this study.|Test/Ref Ratio of LS Means x 100|93.5||||||90.0|89.6|97.6|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||97.6|89.6|
72556251|NCT00835692|144643618|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The pharmacokinetic parameters will be evaluated statistically by an analysis of variance (ANOVA) appropriate for the experimental design of this study.|Test/Ref Ratio of LS Means x 100|93.5||||||90.0|89.5|97.7|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||97.7|89.5|
72618433|NCT02046200|144767936|SUPERIORITY_OR_OTHER|||||||0.43|||||||ANOVA|||||||0.43
72377683|NCT02446743|144264259|OTHER|"Vaccine comparison Pre-booster or pre-1st dose in V72\_75 (Group 3B vs. Group B~\_0\_1)"|Ratio of GMTs|1.48|||||TWO_SIDED|95.0|1.24|1.75|||ANOVA|||Pre booster/Pre first dose-Adjusted geometric mean titers for NZ98/254 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country||1.75|1.24|
72377684|NCT02446743|144264259|OTHER|"Vaccine comparison Post-booster or post-1st dose in V72\_75 (Group 3B vs. Group B~\_0\_1)"|Ratio of GMTs|5.9|||||TWO_SIDED|95.0|4.49|7.76|||ANOVA|||Post booster dose/ post first dose-Adjusted geometric mean titers for NZ98/254 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country.||7.76|4.49|
72556252|NCT01149733|144643619|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of Geometric Means|97.9|||||TWO_SIDED|90.0|91.0|105.32|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the test (T) and reference (R) product fall within the interval of 80-125%.|||105.32|91.00|
72618434|NCT02046200|144767937|SUPERIORITY_OR_OTHER|||||||0.06|||||||ANOVA|||||||0.06
72377685|NCT02446743|144264259|OTHER|Vaccine comparison- Pre-booster or pre-1st dose in V72\_75 \[Group 3B (V72\_41) vs. Group B\_0\_1 (V72\_41)\]|Ratio of GMTs|1.32|||||TWO_SIDED|95.0|1.13|1.54|||ANOVA|||Pre booster/Pre first dose-Adjusted geometric mean titers for NZ98/254 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country.||1.54|1.13|
72377686|NCT02446743|144264259|OTHER|Vaccine comparison- post-booster or post-1st dose in V72\_75 \[Group 3B (V72\_41) vs. Group B\_0\_1 (V72\_41)\]|Ratio of GMTs|8.27|||||TWO_SIDED|95.0|5.83|12.0|||ANOVA|||Post booster/Post first dose-Adjusted geometric mean titers for NZ98/254 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country||12|5.83|
72377687|NCT02446743|144264259|OTHER|Vaccine comparison- Pre-booster or pre-1st dose in V72\_75 \[Group 3B (V72P10) vs. Group B\_0\_1 (V72P10)\]|Ratio of GMTs|1.64|||||TWO_SIDED|95.0|1.22|2.2|||ANOVA|||Pre booster/Pre first dose-Adjusted geometric mean titers for NZ98/254 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country.||2.20|1.22|
72377688|NCT02446743|144264259|OTHER|Vaccine comparison- post-booster or post-1st dose in V72\_75 \[Group 3B (V72P10) vs. Group B\_0\_1 (V72P10)\]|Ratio of GMTs|4.36|||||TWO_SIDED|95.0|2.88|6.58|||ANOVA|||Post booster/Post first dose-Adjusted geometric mean titers for NZ98/254 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country||6.58|2.88|
72377689|NCT02446743|144264259|OTHER|"Vaccine comparison Pre-booster or pre-1st dose in V72\_75 (Group 3B vs. Group B~\_0\_1)"|Ratio of GMTs|1.3|||||TWO_SIDED|95.0|0.97|1.75|||ANOVA|||Pre booster/Pre first dose-Adjusted geometric mean titers for M10713 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country||1.75|0.97|
72377690|NCT02446743|144264259|OTHER|"Vaccine comparison Post-booster or post-1st dose in V72\_75 (Group 3B vs. Group B~\_0\_1)"|Ratio of GMTs|2.6|||||TWO_SIDED|95.0|2.08|3.25|||ANOVA|||Post booster/Post first dose-Adjusted geometric mean titers for M10713 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country||3.25|2.08|
72377691|NCT02446743|144264259|OTHER|Vaccine comparison- Pre-booster or pre-1st dose in V72\_75 \[Group 3B (V72\_41) vs. Group B\_0\_1 (V72\_41)\]|Ratio of GMTs|1.4|||||TWO_SIDED|95.0|0.9|2.18|||ANOVA|||Pre booster/Pre first dose-Adjusted geometric mean titers for M10713 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country.||2.18|0.90|
72377692|NCT02446743|144264259|OTHER|Vaccine comparison- post-booster or post-1st dose in V72\_75 \[Group 3B (V72\_41) vs. Group B\_0\_1 (V72\_41)\]|Ratio of GMTs|2.79|||||TWO_SIDED|95.0|2.04|3.81|||ANOVA|||Post booster/Post first dose-Adjusted geometric mean titers for M10713 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country||3.81|2.04|
72377693|NCT02446743|144264259|OTHER|Vaccine comparison- Pre-booster or pre-1st dose in V72\_75 \[Group 3B (V72P10) vs. Group B\_0\_1 (V72P10)\]|Ratio of GMTs|1.23|||||TWO_SIDED|95.0|0.82|1.82|||ANOVA|||Pre booster/Pre first dose-Adjusted geometric mean titers for M10713 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country.||1.82|0.82|
72377694|NCT02446743|144264259|OTHER|Vaccine comparison- post-booster or post-1st dose in V72\_75 \[Group 3B (V72P10) vs. Group B\_0\_1 (V72P10)\]|Ratio of GMTs|2.45|||||TWO_SIDED|95.0|1.79|3.36|||ANOVA|||Post booster/Post first dose-Adjusted geometric mean titers for M10713 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country||3.36|1.79|
72377695|NCT02446743|144264261|OTHER|1 month post booster/first dose of vaccination: Four-fold Increase (Group 3B vs. Group B\_0\_1) Difference|Vaccine group difference|27.0|||||TWO_SIDED|95.0|20.7|33.0|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||33.0|20.7|
72377696|NCT02446743|144264261|OTHER|1 month post booster/first dose of vaccination: Four-fold Increase \[Group 3B (V72\_41) vs. Group B\_0\_1 (V72\_41) Difference|Vaccine group difference|29.0|||||TWO_SIDED|95.0|19.3|38.7|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||38.7|19.3|
72618435|NCT02046200|144767938|SUPERIORITY_OR_OTHER|||||||0.21|||||||ANOVA|||||||0.21
72618436|NCT02046200|144767939|SUPERIORITY_OR_OTHER|||||||0.09|||||||ANOVA|||||||0.09
72618437|NCT02046200|144767940|SUPERIORITY_OR_OTHER|||||||0.99|||||||ANOVA|||||||0.99
72556253|NCT01149733|144643620|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of Geometric Means|91.81|||||TWO_SIDED|90.0|87.72|96.1|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the test (T) and reference (R) product fall within the interval of 80-125%.|||96.10|87.72|
72556254|NCT01149733|144643621|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of Geometric Means|90.64|||||TWO_SIDED|90.0|86.59|94.89|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the test (T) and reference (R) product fall within the interval of 80-125%.|||94.89|86.59|
72556255|NCT00115063|144643650|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||||||<0.001
72556256|NCT00115063|144643651|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||||||<0.001
72556257|NCT00115063|144643652|SUPERIORITY_OR_OTHER|||||||0.09||95.0||||P-value for systolic blood pressure mean.|t-test, 2 sided|||||||0.09
72556258|NCT00115063|144643652|SUPERIORITY_OR_OTHER|||||||0.6||95.0||||P-value for dystolic blood pressure mean.|t-test, 2 sided|||||||0.60
72556259|NCT00115063|144643653|SUPERIORITY_OR_OTHER|||||||0.73||95.0||||P-value for LDL cholesterol|t-test, 2 sided|||||||0.73
72556260|NCT00115063|144643653|SUPERIORITY_OR_OTHER|||||||0.01||95.0||||P-value for HDL cholesterol|t-test, 2 sided|||||||0.01
72556261|NCT00115063|144643653|SUPERIORITY_OR_OTHER|||||||0.42||95.0||||P-value for triglycerides|t-test, 2 sided|||||||0.42
72618438|NCT01691482|144767947|SUPERIORITY_OR_OTHER||Adjusted Mean|0.058|STANDARD_ERROR_OF_MEAN|0.0046||||95.0|0.049|0.067|||||Treatment: A/S alone. A mixed model analysis, with period, treatment (A+I, I+A, Albuterol alone, Ipratropium alone), FEV1 Baseline, smoking status at Screening, and center fitted as fixed effects and participant as a random effect was used.|||0.067|0.049|
72556262|NCT00115063|144643653|SUPERIORITY_OR_OTHER|||||||0.05||95.0||||P-value for uric acid|t-test, 2 sided|||||||0.05
72556263|NCT00115063|144643654|SUPERIORITY_OR_OTHER|||||||0.16||95.0|||||t-test, 2 sided|||||||0.16
72556264|NCT00115063|144643655|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||t-test, 2 sided|||||||0.001
72556265|NCT01447511|144643670|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||The null hypothesis is that the mean S-warfarin clearance among the five CYP2C9 genotypes under control conditions is the same.||||<0.0001
72556266|NCT01447511|144643670|SUPERIORITY_OR_OTHER||||||=|0.0001|||||||ANOVA|||The null hypothesis is that the mean S-warfarin clearance among the five CYP2C9 genotypes under fluconazole conditions is the same.||||=0.0001
72556267|NCT01447511|144643670|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||The null hypothesis is that the mean S-warfarin clearance among the five CYP2C9 genotypes under rifampin conditions is the same.||||<0.0001
72556268|NCT01447511|144643670|SUPERIORITY_OR_OTHER||||||=|0.3058|||||||ANOVA|||The null hypothesis is that the mean R-warfarin clearance among the five CYP2C9 genotypes under control conditions is the same.||||=0.3058
72556269|NCT01447511|144643670|SUPERIORITY_OR_OTHER||||||=|0.3278|||||||ANOVA|||The null hypothesis is that the mean R-warfarin clearance among the five CYP2C9 genotypes under fluconazole conditions is the same.||||=0.3278
72556270|NCT01447511|144643670|SUPERIORITY_OR_OTHER||||||=|0.6155|||||||ANOVA|||The null hypothesis is that the mean R-warfarin clearance among the five CYP2C9 genotypes under rifampin conditions is the same.||||=0.6155
72556271|NCT03503318|144643710|OTHER||Hazard Ratio (HR)|0.2|||<|0.0001|TWO_SIDED|95.0|0.109|0.367||Threshold for significance at 0.05 level.|Log Rank|||Analysis was performed using the stratified Cox proportional hazard model, with treatment (placebo, TV-46000 q1m and TV-46000 q2m or placebo and TV-46000 overall \[including q1m and q2m\]) as explanatory variable and sex-dose as a stratification factor, and the stratified log rank test p-value (sex-dose as a stratification factor) referred to (TV-46000/placebo) comparison.||0.367|0.109|<0.0001
72556272|NCT03503318|144643710|OTHER||Hazard Ratio (HR)|0.375|||<|0.0001|TWO_SIDED|95.0|0.227|0.618||Threshold for significance at 0.05 level.|Log Rank|||Analysis was performed using the stratified Cox proportional hazard model, with treatment (placebo, TV-46000 q1m and TV-46000 q2m or placebo and TV-46000 overall \[including q1m and q2m\]) as explanatory variable and sex-dose as a stratification factor, and the stratified log rank test p-value (sex-dose as a stratification factor) referred to (TV-46000/placebo) comparison.||0.618|0.227|<0.0001
72556273|NCT00834873|144643752|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|94.77||||||90.0|85.04|105.61|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||105.61|85.04|
72556274|NCT00834873|144643753|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|96.23||||||90.0|90.59|102.23|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||102.23|90.59|
72556275|NCT00834873|144643754|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|96.11||||||90.0|90.45|102.12|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||102.12|90.45|
72556276|NCT01125163|144643755|SUPERIORITY_OR_OTHER|||||||0.59|TWO_SIDED|95.0||||All infants were analyzed according to their assigned groups.|Wilcoxon (Mann-Whitney)|||A non-parametric rank sum analysis was performed as follows so that infants who died before 36 wks and infants who were transfused could be included in an intention-to-treat analysis. Infants were ranked by death (lowest rank) then by number of transfusions (next lowest ranks). For infants who survived and were not transfused, the 36 wks PMA Hct was used as the primary outcome.||||0.59
72618439|NCT01691482|144767947|SUPERIORITY_OR_OTHER||Adjusted Mean|0.071|STANDARD_ERROR_OF_MEAN|0.0046||||95.0|0.062|0.08|||||Treatment: ipratropium alone. A mixed model analysis, with period, treatment (A+I, I+A, Albuterol alone, Ipratropium alone), FEV1 Baseline, smoking status at Screening, and center fitted as fixed effects and participant as a random effect was used.|||0.080|0.062|
72377697|NCT02446743|144264261|OTHER|1 month post booster/first dose of vaccination: Four-fold Increase \[Group 3B (V72P10) vs. Group B\_0\_1 (V72P10) Difference|Vaccine group difference|26.0|||||TWO_SIDED|95.0|18.3|33.9|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||33.9|18.3|
72377698|NCT02446743|144264261|OTHER|1 month post booster/first dose of vaccination: Four-fold Increase (Group 3B vs. Group B\_0\_1) Difference|Vaccine group difference|22.0|||||TWO_SIDED|95.0|15.9|27.9|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval or the difference was calculated using the method of Miettinen and Nurminen||27.9|15.9|
72377699|NCT02446743|144264261|OTHER|1 month post booster/first dose of vaccination: Four-fold Increase \[Group 3B (V72\_41) vs. Group B\_0\_1 (V72\_41) Difference|Vaccine group difference|19.0|||||TWO_SIDED|95.0|11.5|28.5|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||28.5|11.5|
72377700|NCT02446743|144264261|OTHER|1 month post booster/first dose of vaccination: Four-fold Increase \[Group 3B (V72P10) vs. Group B\_0\_1 (V72P10) Difference|Vaccine group difference|23.0|||||TWO_SIDED|95.0|14.6|31.9|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||31.9|14.6|
72377701|NCT02446743|144264261|OTHER|1 month post booster/first dose of vaccination: Four-fold Increase (Group 3B vs. Group B\_0\_1) Difference|Vaccine group difference|38.0|||||TWO_SIDED|95.0|29.8|45.4|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||45.4|29.8|
72377702|NCT02446743|144264261|OTHER|1 month post booster/first dose of vaccination: Four-fold Increase \[Group 3B (V72\_41) vs. Group B\_0\_1 (V72\_41) Difference|Vaccine group difference|55.0|||||TWO_SIDED|95.0|43.5|64.7|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||64.7|43.5|
72377703|NCT02446743|144264261|OTHER|1 month post booster/first dose of vaccination: Four-fold Increase \[Group 3B (V72P10) vs. Group B\_0\_1 (V72P10) Difference|Vaccine group difference|24.0|||||TWO_SIDED|95.0|12.9|35.1|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||35.1|12.9|
72377704|NCT02446743|144264261|OTHER|1 month post booster/first dose of vaccination: Four-fold Increase (Group 3B vs. Group B\_0\_1) Difference|Vaccine group difference|23.0|||||TWO_SIDED|95.0|14.7|30.8|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||30.8|14.7|
72377705|NCT02446743|144264261|OTHER|1 month post booster/first dose of vaccination: Four-fold Increase \[Group 3B (V72\_41) vs. Group B\_0\_1 (V72\_41) Difference|Vaccine group difference|24.0|||||TWO_SIDED|95.0|12.2|35.5|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||35.5|12.2|
72377706|NCT02446743|144264261|OTHER|1 month post booster/first dose of vaccination: Four-fold Increase \[Group 3B (V72P10) vs. Group B\_0\_1 (V72P10) Difference|Vaccine group difference|22.0|||||TWO_SIDED|95.0|10.6|32.9|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||32.9|10.6|
72377707|NCT02446743|144264262|OTHER|Vaccine comparison at Day 4 Group 3B vs Day 34 Group B\_0\_1 (3 days after booster or 2nd dose)|Vaccine group difference|-6.0|||||TWO_SIDED|95.0|-15.0|4.5||Vaccine comparison at Day 4 Group 3B vs Day 34 Group B\_0\_1 (3 days after booster or 2nd dose)|Miettinen and Nurminen score method|||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||4.5|-15.0|
72377708|NCT02446743|144264262|OTHER|Vaccine comparison at Day 4 Group 3B (V72\_41) vs Day 34 Group B\_0\_1 (V72\_41) (3 days after booster or 2nd dose)|Vaccine group difference|-4.0|||||TWO_SIDED|95.0|-17.0|11.4|||Miettinen and Nurminen score method|||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||11.4|-17.0|
72377709|NCT02446743|144264262|OTHER|Vaccine comparison at Day 4 Group 3B (V72P10) vs Day 34 Group B\_0\_1 (V72P10) (3 days after booster or 2nd dose)|Vaccine group difference|-8.0|||||TWO_SIDED|95.0|-20.0|7.3|||Miettinen and Nurminen score method|||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||7.3|-20.0|
72377710|NCT02446743|144264262|OTHER|Vaccine comparison at Day 8 Group 3B vs Day 38 Group B\_0\_1 (7 days after booster or 2nd dose)|Vaccine group difference|1.0|||||TWO_SIDED|95.0|-0.9|6.2|||Miettinen and Nurminen score method|||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||6.2|-0.9|
72556277|NCT01125163|144643756|SUPERIORITY_OR_OTHER|||||||0.64|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||A non-parametric rank sum analysis was performed as follows so that infants who died before 36 wks and infants who were transfused could be included in an intention-to-treat analysis. Infants were ranked by death (lowest rank) then by number of transfusions (next lowest ranks). For infants who survived and were not transfused, the 36 wks PMA Hct was used as the primary outcome.||||0.64
72433598|NCT00991276|144380368|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-11.17|STANDARD_ERROR_OF_MEAN|4.14||0.008|TWO_SIDED|95.0|-19.37|-2.97||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||Stage N3 sleep/SWS: P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||-2.97|-19.37|0.0080
72377711|NCT02446743|144264262|OTHER|Vaccine comparison at Day 8 Group 3B (V72\_41) vs Day 38 Group B\_0\_1 (V72\_41) (7 days after booster or 2nd dose)|Vaccine group difference|0.0|||||TWO_SIDED|95.0|-3.6|8.8|||Miettinen and Nurminen score method|||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||8.8|-3.6|
72377712|NCT02446743|144264262|OTHER|Vaccine comparison at Day 8 Group 3B (V72P10) vs Day 34 Group B\_0\_1 (V72P10) (7 days after booster or 2nd dose)|Vaccine group difference|2.0|||||TWO_SIDED|95.0|-2.5|11.0|||Miettinen and Nurminen score method|||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||11.0|-2.5|
72377713|NCT02446743|144264262|OTHER|Vaccine comparison at Day 31 Group 3B (V72\_41) vs Day 61 Group B\_0\_1(V72\_41) (1 month after booster or 2nd dose)|Vaccine group difference|0.0|||||TWO_SIDED|95.0|-3.6|4.4|||Miettinen and Nurminen score method|||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||4.4|-3.6|
72377714|NCT02446743|144264262|OTHER|Vaccine comparison at Day 31 Group 3B (V72P10) vs Day 61 Group B\_0\_1 (V72P10) (1 month after booster or 2nd dose)|Vaccine group difference|2.0|||||TWO_SIDED|95.0|-2.3|7.8|||Miettinen and Nurminen score method|||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||7.8|-2.3|
72377715|NCT02446743|144264262|OTHER|Vaccine comparison at Day 31 Group 3B vs Day 61 Group B\_0\_1 (1 month after booster or 2nd dose)|Vaccine group difference|1.0|||||TWO_SIDED|95.0|-0.9|4.1|||Miettinen and Nurminen score method|||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||4.1|-0.9|
72377716|NCT02446743|144264262|OTHER|Vaccine comparison at Day 4 Group 3B (V72\_41) vs Day 34 Group B\_0\_1 (V72\_41) (3 days after booster or 2nd dose)|Vaccine group difference|-20.0|||||TWO_SIDED|95.0|-35.2|-7.5|||Miettinen and Nurminen score method|||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||-7.5|-35.2|
72377717|NCT02446743|144264262|OTHER|Vaccine comparison at Day 4 Group 3B (V72P10) vs Day 34 Group B\_0\_1 (V72P10) (3 days after booster or 2nd dose)|Vaccine group difference|-32.0|||||TWO_SIDED|95.0|-46.5|-15.7|||Miettinen and Nurminen score method|||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||-15.7|-46.5|
72377718|NCT02446743|144264262|OTHER|Vaccine comparison at Day 4 Group 3B vs Day 34 Group B\_0\_1 (3 days after booster or 2nd dose)|Vaccine group difference|-28.0|||||TWO_SIDED|95.0|-38.4|-17.1|||Miettinen and Nurminen score method|||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||-17.1|-38.4|
72377719|NCT02446743|144264262|OTHER|Vaccine comparison at Day 8 Group 3B (V72\_41) vs Day 38 Group B\_0\_1 (V72\_41) (7 days after booster or 2nd dose)|Vaccine group difference|-6.0|||||TWO_SIDED|95.0|-19.2|9.2|||Miettinen and Nurminen score method|||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||9.2|-19.2|
72377720|NCT02446743|144264262|OTHER|Vaccine comparison at Day 8 Group 3B (V72\_41) vs Day 38 Group B\_0\_1 (V72\_41) (7 days after booster or 2nd dose)|Vaccine group difference|-2.0|||||TWO_SIDED|95.0|-14.1|12.3|||Miettinen and Nurminen score method|||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||12.3|-14.1|
72377721|NCT02446743|144264262|OTHER|Vaccine comparison at Day 8 Group 3B vs Day 38 Group B\_0\_1 (7 days after booster or 2nd dose)|Vaccine group difference|-5.0|||||TWO_SIDED|95.0|-13.6|5.6|||Miettinen and Nurminen score method|||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||5.6|-13.6|
72377722|NCT02446743|144264262|OTHER|Vaccine comparison at Day 31 Group 3B (V72\_41) vs Day 61 Group B\_0\_1 (V72\_41) (1 month after booster or 2nd dose)|Vaccine group difference|12.0|||||TWO_SIDED|95.0|3.6|21.6|||Miettinen and Nurminen score method|||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||21.6|3.6|
72377723|NCT02446743|144264262|OTHER|Vaccine comparison at Day 31 Group 3B (V72P10) vs Day 61 Group B\_0\_1 (V72P10) (1 month after booster or 2nd dose)|Vaccine group difference|15.0|||||TWO_SIDED|95.0|6.4|24.6|||Miettinen and Nurminen score method|||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||24.6|6.4|
72377724|NCT02446743|144264262|OTHER|Vaccine comparison at Day 31 Group 3B vs Day 61 Group B\_0\_1 (1 month after booster or 2nd dose)|Vaccine group difference|14.0|||||TWO_SIDED|95.0|7.6|20.3|||Miettinen and Nurminen score method|||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||20.3|7.6|
72433599|NCT00991276|144380368|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-4.97|STANDARD_ERROR_OF_MEAN|2.85||0.0834|TWO_SIDED|95.0|-10.61|0.67||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||Stage R sleep: P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||0.67|-10.61|0.0834
72433600|NCT00991276|144380368|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|18.59|STANDARD_ERROR_OF_MEAN|2.83|<|0.0001|TWO_SIDED|95.0|12.99|24.19||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||Stage R sleep: P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||24.19|12.99|<0.0001
72377725|NCT02446743|144264263|OTHER|Vaccine comparison at Day 4 Group 3B vs Day 34 Group B\_0\_1 (3 days after booster or 2nd dose)|vaccine group difference|-44.0|||||TWO_SIDED|95.0|-52.7|-33.1|||Miettinen and Nurminen score method|||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||-33.1|-52.7|
72377726|NCT02446743|144264263|OTHER|Vaccine comparison at Day 8 Group 3B vs Day 38 Group B\_0\_1 (7 days after booster or 2nd dose)|vaccine group difference|-1.0|||||TWO_SIDED|95.0|-3.9|3.6|||Miettinen and Nurminen score method|||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||3.6|-3.9|
72377727|NCT02446743|144264263|OTHER|Vaccine comparison at Day 31 Group 3B vs Day 61 Group B\_0\_1 (1 month after booster or 2nd dose)|vaccine group difference|0.0|||||TWO_SIDED|95.0|-2.7|2.4|||Miettinen and Nurminen score method|||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||2.4|-2.7|
72377728|NCT02446743|144264263|OTHER|Vaccine comparison at Day 4 Group 3B (V72\_41) vs Day 34 Group B\_0\_1 (V72\_41) (3 days after booster or 2nd dose)|vaccine group difference|-46.0|||||TWO_SIDED|95.0|-58.4|-29.8|||Miettinen and Nurminen score method|||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||-29.8|-58.4|
72377729|NCT02446743|144264263|OTHER|Vaccine comparison at Day 8 Group 3B (V72\_41) vs Day 38 Group B\_0\_1 (V72\_41) (7 days after booster or 2nd dose)|vaccine group difference|-3.0|||||TWO_SIDED|95.0|-7.7|5.1|||Miettinen and Nurminen score method|||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||5.1|-7.7|
72377730|NCT02446743|144264263|OTHER|Vaccine comparison at Day 31 Group 3B (V72\_41) vs Day 61 Group B\_0\_1 (V72\_41) (1 month after booster or 2nd dose)|vaccine group difference|-1.0|||||TWO_SIDED|95.0|-5.7|3.7|||Miettinen and Nurminen score method|||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||3.7|-5.7|
72377731|NCT02446743|144264263|OTHER|Vaccine comparison at Day 4 Group 3B (V72P10) vs Day 34 Group B\_0\_1 (V72P10) (3 days after booster or 2nd dose)|Vaccine group difference|-40.0|||||TWO_SIDED|95.0|-51.8|-25.4|||Miettinen and Nurminen score method|||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||-25.4|-51.8|
72377732|NCT02446743|144264263|OTHER|Vaccine comparison at Day 8 Group 3B (V72P10) vs Day 38 Group B\_0\_1 (V72P10) (7 days after booster or 2nd dose)|vaccine group difference|1.0|||||TWO_SIDED|95.0|-3.3|9.0|||Miettinen and Nurminen score method|||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||9.0|-3.3|
72377733|NCT02446743|144264263|OTHER|Vaccine comparison at Day 31 Group 3B (V72P10) vs Day 61 Group B\_0\_1 (V72P10) (1 month after booster or 2nd dose)|vaccine group difference|1.0|||||TWO_SIDED|95.0|-2.4|5.0|||Miettinen and Nurminen score method|||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||5.0|-2.4|
72377734|NCT02446743|144264263|OTHER|Vaccine comparison at Day 4 Group 3B vs Day 34 Group B\_0\_1 (3 days after booster or 2nd dose)|vaccine group difference|-4.0|||||TWO_SIDED|95.0|-12.4|5.8|||Miettinen and Nurminen score method|||3 days post vaccination-The group difference in percentages of subjects with response N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||5.8|-12.4|
72377735|NCT02446743|144264263|OTHER|Vaccine comparison at Day 8 Group 3B vs Day 38 Group B\_0\_1 (7 days after booster or 2nd dose)|vaccine group difference|2.0|||||TWO_SIDED|95.0|-2.2|7.7|||Miettinen and Nurminen score method|||7 days post vaccination-The group difference in percentages of subjects with response N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||7.7|-2.2|
72377736|NCT02446743|144264263|OTHER|Vaccine comparison at Day 31 Group 3B vs Day 61 Group B\_0\_1 (1 month after booster or 2nd dose)|vaccine group difference|6.0|||||TWO_SIDED|95.0|2.8|10.5|||Miettinen and Nurminen score method|||1 month post vaccination-The group difference in percentages of subjects with response N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||10.5|2.8|
72377737|NCT02446743|144264263|OTHER|Vaccine comparison at Day 4 Group 3B (V72\_41) vs Day 34 Group B\_0\_1 (V72\_41) (3 days after booster or 2nd dose)|vaccine group difference|-5.0|||||TWO_SIDED|95.0|-17.8|10.6|||Miettinen and Nurminen score method|||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||10.6|-17.8|
72377738|NCT02446743|144264263|OTHER|Vaccine comparison at Day 8 Group 3B (V72\_41) vs Day 38 Group B\_0\_1 (V72\_41) (7 days after booster or 2nd dose)|vaccine group difference|2.0|||||TWO_SIDED|95.0|-3.2|13.0|||Miettinen and Nurminen score method|||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||13.0|-3.2|
72377739|NCT02446743|144264263|OTHER|Vaccine comparison at Day 31 Group 3B (V72\_41) vs Day 61 Group B\_0\_1 (V72\_41) (1 month after booster or 2nd dose)|vaccine group difference|9.0|||||TWO_SIDED|95.0|3.7|16.5|||Miettinen and Nurminen score method|||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||16.5|3.7|
72377740|NCT02446743|144264263|OTHER|Vaccine comparison at Day 4 Group 3B (V72P10) vs Day 34 Group B\_0\_1 (V72P10) (3 days after booster or 2nd dose)|vaccine group difference|-2.0|||||TWO_SIDED|95.0|-11.8|11.0|||Miettinen and Nurminen score method|||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||11.0|-11.8|
72377741|NCT02446743|144264263|OTHER|Vaccine comparison at Day 8 Group 3B (V72\_41) vs Day 38 Group B\_0\_1 (V72\_41) (7 days after booster or 2nd dose)|vaccine group difference|1.0|||||TWO_SIDED|95.0|-4.6|10.1|||Miettinen and Nurminen score method|||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||10.1|-4.6|
72377742|NCT02446743|144264263|OTHER|Vaccine comparison at Day 31 Group 3B (V72P10) vs Day 61 Group B\_0\_1 (V72P10) (1 month days after booster or 2nd dose)|vaccine group difference|4.0|||||TWO_SIDED|95.0|-0.8|9.5|||Miettinen and Nurminen score method|||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||9.5|-0.8|
72377743|NCT02446743|144264264|OTHER|Vaccine comparison at Day 4 Group 3B vs Day 34 Group B\_0\_1 (3 days after booster or 2nd dose)|vaccine group difference|-45.0|||||TWO_SIDED|95.0|-54.4|-34.3|||Miettinen and Nurminen score method|||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||-34.3|-54.4|
72377744|NCT02446743|144264264|OTHER|Vaccine comparison at Day 8 Group 3B vs Day 38 Group B\_0\_1 (7 days after booster or 2nd dose)|vaccine group difference|-1.0|||||TWO_SIDED|95.0|-4.5|5.2|||Miettinen and Nurminen score method|||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||5.2|-4.5|
72377745|NCT02446743|144264264|OTHER|Vaccine comparison at Day 31 Group 3B vs Day 61 Group B\_0\_1 (1 month after booster or 2nd dose)|vaccine group difference|1.0|||||TWO_SIDED|95.0|-1.9|3.9|||Miettinen and Nurminen score method|||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||3.9|-1.9|
72377746|NCT02446743|144264264|OTHER|Vaccine comparison at Day 4 Group 3B (V72\_41) vs Day 34 Group B\_0\_1 (V72\_41) (3 days after booster or 2nd dose)|vaccine group difference|-48.0|||||TWO_SIDED|95.0|-60.8|-32.0|||Miettinen and Nurminen score method|||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||-32.0|-60.8|
72377747|NCT02446743|144264264|OTHER|Vaccine comparison at Day 8 Group 3B (V72\_41) vs Day 38 Group B\_0\_1 (V72\_41) (7 days after booster or 2nd dose)|vaccine group difference|-1.0|||||TWO_SIDED|95.0|-7.3|10.1|||Miettinen and Nurminen score method|||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||10.1|-7.3|
72377748|NCT02446743|144264264|OTHER|Vaccine comparison at Day 31 Group 3B (V72\_41) vs Day 61 Group B\_0\_1 (V72\_41) (1 month after booster or 2nd dose)|vaccine group difference|-1.0|||||TWO_SIDED|95.0|-5.7|3.7|||Miettinen and Nurminen score method|||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||3.7|-5.7|
72433601|NCT00991276|144380368|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-23.56|STANDARD_ERROR_OF_MEAN|2.81|<|0.0001|TWO_SIDED|95.0|-29.12|-18.01||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||Stage R sleep: P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||-18.01|-29.12|<0.0001
72377749|NCT02446743|144264264|OTHER|Vaccine comparison at Day 4 Group 3B (V72P10) vs Day 34 Group B\_0\_1 (V72P10) (3 days after booster or 2nd dose)|vaccine group difference|-41.0|||||TWO_SIDED|95.0|-53.3|-25.5|||Miettinen and Nurminen score method|||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||-25.5|-53.3|
72377750|NCT02446743|144264264|OTHER|Vaccine comparison at Day 8 Group 3B (V72P10) vs Day 38 Group B\_0\_1 (V72P10) (7 days after booster or 2nd dose)|vaccine group difference|0.0|||||TWO_SIDED|95.0|-4.8|8.1|||Miettinen and Nurminen score method|||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||8.1|-4.8|
72377751|NCT02446743|144264264|OTHER|Vaccine comparison at Day 31 Group 3B (V72P10) vs Day 61 Group B\_0\_1 (V72P10) (1 month days after booster or 2nd dose)|vaccine group difference|3.0|||||TWO_SIDED|95.0|-0.6|7.8|||Miettinen and Nurminen score methodx|||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||7.8|-0.6|
72377752|NCT02446743|144264264|OTHER|Vaccine comparison at Day 4 Group 3B vs Day 34 Group B\_0\_1 (3 days after booster or 2nd dose)|vaccine group difference|-6.0|||||TWO_SIDED|95.0|-15.9|4.6|||Miettinen and Nurminen score method|||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||4.6|-15.9|
72377753|NCT02446743|144264264|OTHER|Vaccine comparison at Day 8 Group 3B vs Day 38 Group B\_0\_1 (7 days after booster or 2nd dose)|vaccine group difference|1.0|||||TWO_SIDED|95.0|-0.9|6.2|||Miettinen and Nurminen score method|||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||6.2|-0.9|
72377754|NCT02446743|144264264|OTHER|Vaccine comparison at Day 31 Group 3B vs Day 61 Group B\_0\_1 (1 month after booster or 2nd dose)|vaccine group difference|1.0|||||TWO_SIDED|95.0|-0.9|4.1|||Miettinen and Nurminen score method|||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||4.1|-0.9|
72377755|NCT02446743|144264264|OTHER|Vaccine comparison at Day 4 Group 3B (V72\_41) vs Day 34 Group B\_0\_1 (V72\_41) (3 days after booster or 2nd dose)|vaccine group difference|-6.0|||||TWO_SIDED|95.0|-19.2|10.3|||Miettinen and Nurminen score method|||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||10.3|-19.2|
72377756|NCT02446743|144264264|OTHER|Vaccine comparison at Day 8 Group 3B (V72\_41) vs Day 38 Group B\_0\_1 (V72\_41) (7 days after booster or 2nd dose)|vaccine group difference|0.0|||||TWO_SIDED|95.0|-3.6|8.8|||Miettinen and Nurminen score method|||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||8.8|-3.6|
72377757|NCT02446743|144264264|OTHER|Vaccine comparison at Day 31 Group 3B (V72\_41) vs Day 61 Group B\_0\_1 (V72\_41) (1 month after booster or 2nd dose)|vaccine group difference|0.0|||||TWO_SIDED|95.0|-3.6|4.4|||Miettinen and Nurminen score method|||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||4.4|-3.6|
72377758|NCT02446743|144264264|OTHER|Vaccine comparison at Day 4 Group 3B (V72P10) vs Day 34 Group B\_0\_1 (V72P10) (3 days after booster or 2nd dose)|vaccine group difference|-6.0|||||TWO_SIDED|95.0|-19.4|9.1|||Miettinen and Nurminen score method|||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||9.1|-19.4|
72377759|NCT02446743|144264264|OTHER|Vaccine comparison at Day 8 Group 3B (V72P10) vs Day 38 Group B\_0\_1 (V72P10) (7 days after booster or 2nd dose)|vaccine group difference|2.0|||||TWO_SIDED|95.0|-2.5|11.0|||Miettinen and Nurminen score method|||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||11.0|-2.5|
72377760|NCT02446743|144264264|OTHER|Vaccine comparison at Day 31 Group 3B (V72P10) vs Day 61 Group B\_0\_1 (V72P10) (1 month days after booster or 2nd dose)|vaccine group difference|2.0|||||TWO_SIDED|95.0|-2.3|7.8|||Miettinen and Nurminen score method|||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||7.8|-2.3|
72377761|NCT02446743|144264264|OTHER|Vaccine comparison at Day 4 Group 3B vs Day 34 Group B\_0\_1 (3 days after booster or 2nd dose)|vaccine group difference|-26.0|||||TWO_SIDED|95.0|-36.6|-15.7|||Miettinen and Nurminen score method|||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||-15.7|-36.6|
72493934|NCT03178487|144516777|SUPERIORITY|To preserve the overall type I error rate at α=0.05 level, a step-down approach was used to test the primary and multiplicity-controlled key secondary endpoints. The testing began with the primary endpoint at α=0.05 and continued conditional on significance of higher-ranked endpoint.|Least Squares (LS) Mean Difference|-0.91|||<|0.001|TWO_SIDED|95.0|-1.14|-0.68|||Mixed Effect Model Repeated Measurement|MMRM model includes treatment, visit, treatment-by-visit interaction as fixed effects and Screening hsCRP level and Baseline value as covariates.|Treatment difference = Upadacitinib - Placebo|||-0.68|-1.14|<0.001
72556278|NCT00830258|144643832|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Geometric Test/Ref Ratio x 100|105.76||||||90.0|98.17|113.93|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||113.93|98.17|
72377762|NCT02446743|144264264|OTHER|Vaccine comparison at Day 8 Group 3B vs Day 38 Group B\_0\_1 (7 days after booster or 2nd dose)|vaccine group difference|-3.0|||||TWO_SIDED|95.0|-13.3|8.5|||Miettinen and Nurminen score method|||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||8.5|-13.3|
72556279|NCT00830258|144643833|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Geometric Test/Ref Ratio x 100|110.45||||||90.0|104.31|116.96|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||116.96|104.31|
72377763|NCT02446743|144264264|OTHER|Vaccine comparison at Day 31 Group 3B vs Day 61 Group B\_0\_1 (1 month after booster or 2nd dose)|vaccine group difference|21.0|||||TWO_SIDED|95.0|12.8|28.3|||Miettinen and Nurminen score method|||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||28.3|12.8|
72377764|NCT02446743|144264264|OTHER|Vaccine comparison at Day 4 Group 3B (V72\_41) vs Day 34 Group B\_0\_1 (V72\_41) (3 days after booster or 2nd dose)|vaccine group difference|-18.0|||||TWO_SIDED|95.0|-32.5|-5.8|||Miettinen and Nurminen score method|||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||-5.8|-32.5|
72377765|NCT02446743|144264264|OTHER|Vaccine comparison at Day 8 Group 3B (V72\_41) vs Day 38 Group B\_0\_1 (V72\_41) (7 days after booster or 2nd dose)|vaccine group difference|-7.0|||||TWO_SIDED|95.0|-22.3|9.5|||Miettinen and Nurminen score method|||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||9.5|-22.3|
72377766|NCT02446743|144264264|OTHER|Vaccine comparison at Day 31 Group 3B (V72\_41) vs Day 61 Group B\_0\_1 (V72\_41) (1 month after booster or 2nd dose)|vaccine group difference|20.0|||||TWO_SIDED|95.0|8.4|31.3|||Miettinen and Nurminen score method|||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||31.3|8.4|
72377767|NCT02446743|144264264|OTHER|Vaccine comparison at Day 4 Group 3B (V72P10) vs Day 34 Group B\_0\_1 (V72P10) (3 days after booster or 2nd dose)|vaccine group difference|-31.0|||||TWO_SIDED|95.0|-46.0|-15.5|||Miettinen and Nurminen score method|||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||-15.5|-46.0|
72377768|NCT02446743|144264264|OTHER|Vaccine comparison at Day 8 Group 3B (V72P10) vs Day 38 Group B\_0\_1 (V72P10) (7 days after booster or 2nd dose)|vaccine group difference|3.0|||||TWO_SIDED|95.0|-10.8|18.8|||Miettinen and Nurminen score method|||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||18.8|-10.8|
72377769|NCT02446743|144264264|OTHER|Vaccine comparison at Day 31 Group 3B (V72P10) vs Day 61 Group B\_0\_1 (V72P10) (1 month days after booster or 2nd dose)|vaccine group difference|22.0|||||TWO_SIDED|95.0|12.1|32.8|||Miettinen and Nurminen score method|||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||32.8|12.1|
72377770|NCT02446743|144264264|OTHER|Vaccine comparison at Day 4 Group 3B vs Day 34 Group B\_0\_1 (3 days after booster or 2nd dose)|vaccine group difference|-4.0|||||TWO_SIDED|95.0|-13.4|7.1|||Miettinen and Nurminen score method|||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||7.1|-13.4|
72377771|NCT02446743|144264264|OTHER|Vaccine comparison at Day 8 Group 3B vs Day 38 Group B\_0\_1 (7 days after booster or 2nd dose)|vaccine group difference|2.0|||||TWO_SIDED|95.0|-3.2|8.5|||Miettinen and Nurminen score method|||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||8.5|-3.2|
72377772|NCT02446743|144264264|OTHER|Vaccine comparison at Day 31 Group 3B vs Day 61 Group B\_0\_1 (1 month after booster or 2nd dose)|vaccine group difference|8.0|||||TWO_SIDED|95.0|4.2|13.2|||Miettinen and Nurminen score method|||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||13.2|4.2|
72493935|NCT03178487|144516778|SUPERIORITY|To preserve the overall type I error rate at α=0.05 level, a step-down approach was used to test the primary and multiplicity-controlled key secondary endpoints. The testing began with the primary endpoint at α=0.05 and continued conditional on significance of higher-ranked endpoint.|LS Mean Difference|-6.71|||<|0.001|TWO_SIDED|95.0|-9.01|-4.41|||ANCOVA|ANCOVA model including treatment and Screening hsCRP level as fixed factors and Baseline value as covariate.|Treatment difference = Upadacitinib - Placebo|||-4.41|-9.01|<0.001
72377773|NCT02446743|144264264|OTHER|Vaccine comparison at Day 4 Group 3B (V72\_41) vs Day 34 Group B\_0\_1 (V72\_41) (3 days after booster or 2nd dose)|vaccine group difference|0.0|||||TWO_SIDED|95.0|-15.1|16.1|||Miettinen and Nurminen score method|||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||16.1|-15.1|
72556280|NCT00830258|144643834|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Geometric Test/Ref Ratio x 100|110.61||||||90.0|104.39|117.2|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||117.20|104.39|
72556281|NCT05511935|144643866|SUPERIORITY||Mean Difference (Final Values)|1.75|STANDARD_ERROR_OF_MEAN|3.69||0.64|TWO_SIDED|95.0|-5.57|9.06|||t-test, 2 sided|||||9.06|-5.57|0.64
72377774|NCT02446743|144264264|OTHER|Vaccine comparison at Day 8 Group 3B (V72\_41) vs Day 38 Group B\_0\_1 (V72\_41) (7 days after booster or 2nd dose)|vaccine group difference|2.0|||||TWO_SIDED|95.0|-4.7|13.9|||Miettinen and Nurminen score method|||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||13.9|-4.7|
72377775|NCT02446743|144264264|OTHER|Vaccine comparison at Day 31 Group 3B (V72\_41) vs Day 61 Group B\_0\_1 (V72\_41) (1 month after booster or 2nd dose)|vaccine group difference|12.0|||||TWO_SIDED|95.0|5.9|20.9|||Miettinen and Nurminen score method|||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||20.9|5.9|
72377776|NCT02446743|144264264|OTHER|Vaccine comparison at Day 4 Group 3B (V72P10) vs Day 34 Group B\_0\_1 (V72P10) (3 days after booster or 2nd dose)|vaccine group difference|-5.0|||||TWO_SIDED|95.0|-16.7|8.6|||Miettinen and Nurminen score method|||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||8.6|-16.7|
72377777|NCT02446743|144264264|OTHER|Vaccine comparison at Day 8 Group 3B (V72P10) vs Day 38 Group B\_0\_1 (V72P10) (7 days after booster or 2nd dose)|vaccine group difference|1.0|||||TWO_SIDED|95.0|-5.7|11.1|||Miettinen and Nurminen score method|||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||11.1|-5.7|
72377778|NCT02446743|144264264|OTHER|Vaccine comparison at Day 31 Group 3B (V72P10) vs Day 61 Group B\_0\_1 (V72P10) (1 month after booster or 2nd dose)|vaccine group difference|5.0|||||TWO_SIDED|95.0|-0.7|11.1||||||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||11.1|-0.7|
72377779|NCT02446743|144264265|OTHER|Vaccine comparison at Day 4 Group 3B vs Day 34 Group B\_0\_1 (3 days after booster or 2nd dose)|vaccine group difference|-30.0|||||TWO_SIDED|95.0|-40.4|-19.0|||Miettinen and Nurminen score method|||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||-19.0|-40.4|
72377780|NCT02446743|144264265|OTHER|Vaccine comparison at Day 8 Group 3B vs Day 38 Group B\_0\_1 (7 days after booster or 2nd dose)|vaccine group difference|3.0|||||TWO_SIDED|95.0|-2.6|10.3|||Miettinen and Nurminen score method|||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||10.3|-2.6|
72377781|NCT02446743|144264265|OTHER|Vaccine comparison at Day 31 Group 3B vs Day 61 Group B\_0\_1 (1 month after booster or 2nd dose)|vaccine group difference|8.0|||||TWO_SIDED|95.0|3.9|12.5|||Miettinen and Nurminen score method|||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||12.5|3.9|
72377782|NCT02446743|144264265|OTHER|Vaccine comparison at Day 4 Group 3B (V72\_41) vs Day 34 Group B\_0\_1 (V72\_41) (3 days after booster or 2nd dose)|vaccine group difference|-27.0|||||TWO_SIDED|95.0|-41.8|-12.9|||Miettinen and Nurminen score method|||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||-12.9|-41.8|
72377783|NCT02446743|144264265|OTHER|Vaccine comparison at Day 8 Group 3B (V72\_41) vs Day 38 Group B\_0\_1 (V72\_41) (7 days after booster or 2nd dose)|vaccine group difference|3.0|||||TWO_SIDED|95.0|-6.0|16.2|||Miettinen and Nurminen score method|||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||16.2|-6.0|
72618440|NCT01691482|144767947|SUPERIORITY_OR_OTHER||Adjusted Mean|0.053|STANDARD_ERROR_OF_MEAN|0.0046||||95.0|0.044|0.062|||||Treatment: A+I. A mixed model analysis, with period, treatment (A+I, I+A, Albuterol alone, Ipratropium alone), FEV1 Baseline, smoking status at Screening, and center fitted as fixed effects and participant as a random effect was used.|||0.062|0.044|
72377784|NCT02446743|144264265|OTHER|Vaccine comparison at Day 31 Group 3B (V72\_41) vs Day 61 Group B\_0\_1 (V72\_41) (1 month after booster or 2nd dose)|vaccine group difference|7.0|||||TWO_SIDED|95.0|1.4|15.2|||Miettinen and Nurminen score method|||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||15.2|1.4|
72377785|NCT02446743|144264265|OTHER|Vaccine comparison at Day 4 Group 3B (V72P10) vs Day 34 Group B\_0\_1 (V72P10) (3 days after booster or 2nd dose)|vaccine group difference|-31.0|||||TWO_SIDED|95.0|-45.1|-14.6|||Miettinen and Nurminen score method|||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||-14.6|-45.1|
72377786|NCT02446743|144264265|OTHER|Vaccine comparison at Day 8 Group 3B (V72P10) vs Day 38 Group B\_0\_1 (V72P10) (7 days after booster or 2nd dose)|vaccine group difference|4.0|||||TWO_SIDED|95.0|1.9|13.5|||Miettinen and Nurminen score method|||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||13.5|1.9|
72556282|NCT05511935|144643867|SUPERIORITY||Mean Difference (Final Values)|1.3|STANDARD_ERROR_OF_MEAN|1.81||0.47|TWO_SIDED|95.0|-2.28|4.89|||t-test, 2 sided|||||4.89|-2.28|0.47
72556283|NCT05511935|144643868|SUPERIORITY||Mean Difference (Final Values)|-2.33|STANDARD_ERROR_OF_MEAN|4.25||0.59|TWO_SIDED|95.0|-10.77|6.11|||t-test, 2 sided|||||6.11|-10.77|0.59
72556284|NCT05511935|144643869|SUPERIORITY||Mean Difference (Final Values)|-1.61|STANDARD_ERROR_OF_MEAN|5.53||0.77|TWO_SIDED|95.0|-12.61|9.38|||t-test, 2 sided|||||9.38|-12.61|0.77
72377787|NCT02446743|144264265|OTHER|Vaccine comparison at Day 31 Group 3B (V72P10) vs Day 61 Group B\_0\_1 (V72P10) (1 month after booster or 2nd dose)|vaccine group difference|8.0|||||TWO_SIDED|95.0|4.4|15.0|||Miettinen and Nurminen score method|||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||15.0|4.4|
72377788|NCT02446743|144264265|OTHER|Vaccine comparison at Day 4 Group 3B vs Day 34 Group B\_0\_1 (3 days after booster or 2nd dose)|vaccine group difference|-5.0|||||TWO_SIDED|95.0|-16.0|6.5|||Miettinen and Nurminen score method|||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||6.5|-16.0|
72377789|NCT02446743|144264265|OTHER|Vaccine comparison at Day 8 Group 3B vs Day 38 Group B\_0\_1 (7 days after booster or 2nd dose)|vaccine group difference|1.0|||||TWO_SIDED|95.0|-0.9|6.2|||Miettinen and Nurminen score method|||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||6.2|-0.9|
72377790|NCT02446743|144264265|OTHER|Vaccine comparison at Day 31 Group 3B vs Day 61 Group B\_0\_1 (1 month after booster or 2nd dose)|vaccine group difference|2.0|||||TWO_SIDED|95.0|-0.33|5.0|||Miettinen and Nurminen score method|||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||5.0|-0.33|
72377791|NCT02446743|144264265|OTHER|Vaccine comparison at Day 4 Group 3B (V72\_41) vs Day 34 Group B\_0\_1 (V72\_41) (3 days after booster or 2nd dose)|vaccine group difference|-6.0|||||TWO_SIDED|95.0|-20.5|10.6|||Miettinen and Nurminen score method|||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||10.6|-20.5|
72377792|NCT02446743|144264265|OTHER|Vaccine comparison at Day 8 Group 3B (V72\_41) vs Day 38 Group B\_0\_1 (V72\_41) (7 days after booster or 2nd dose)|vaccine group difference|0.0|||||TWO_SIDED|95.0|-3.6|8.8|||Miettinen and Nurminen score method|||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||8.8|-3.6|
72377793|NCT02446743|144264265|OTHER|Vaccine comparison at Day 31 Group 3B (V72\_41) vs Day 61 Group B\_0\_1 (V72\_41) (1 month after booster or 2nd dose)|vaccine group difference|0.0|||||TWO_SIDED|95.0|-3.6|4.4|||Miettinen and Nurminen score method|||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||4.4|-3.6|
72377794|NCT02446743|144264265|OTHER|Vaccine comparison at Day 4 Group 3B (V72P10) vs Day 34 Group B\_0\_1 (V72P10) (3 days after booster or 2nd dose)|vaccine group difference|-4.0|||||TWO_SIDED|95.0|-19.4|13.0|||Miettinen and Nurminen score method|||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||13.0|-19.4|
72377795|NCT02446743|144264265|OTHER|Vaccine comparison at Day 8 Group 3B (V72P10) vs Day 38 Group B\_0\_1 (V72P10) (7 days after booster or 2nd dose)|vaccine group difference|2.0|||||TWO_SIDED|95.0|-2.5|11.0|||Miettinen and Nurminen score method|||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||11.0|-2.5|
72377796|NCT02446743|144264265|OTHER|Vaccine comparison at Day 31 Group 3B (V72P10) vs Day 61 Group B\_0\_1 (V72P10) (1 month after booster or 2nd dose)|vaccine group difference|3.0|||||TWO_SIDED|95.0|-1.2|9.4|||Miettinen and Nurminen score method|||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||9.4|-1.2|
72377797|NCT02446743|144264265|OTHER|Vaccine comparison at Day 4 Group 3B vs Day 34 Group B\_0\_1 (3 days after booster or 2nd dose)|vaccine group difference|-20.0|||||TWO_SIDED|95.0|-30.0|-11.1|||Miettinen and Nurminen score method|||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||-11.1|-30.0|
72377798|NCT02446743|144264265|OTHER|Vaccine comparison at Day 8 Group 3B vs Day 38 Group B\_0\_1 (7 days after booster or 2nd dose)|vaccine group difference|4.0|||||TWO_SIDED|95.0|-7.6|15.7|||Miettinen and Nurminen score method|||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||15.7|-7.6|
72377799|NCT02446743|144264265|OTHER|Vaccine comparison at Day 31 Group 3B vs Day 61 Group B\_0\_1 (1 month after booster or 2nd dose)|vaccine group difference|32.0|||||TWO_SIDED|95.0|23.2|40.2|||Miettinen and Nurminen score method|||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||40.2|23.2|
72556285|NCT05511935|144643870|SUPERIORITY||Mean Difference (Final Values)|-12.21|STANDARD_ERROR_OF_MEAN|2.89|<|0.001|TWO_SIDED|95.0|-17.95|-6.47|||t-test, 2 sided|||||-6.47|-17.95|<0.001
72556286|NCT05511935|144643871|SUPERIORITY||Mean Difference (Final Values)|1.62|STANDARD_ERROR_OF_MEAN|1.87||0.39|TWO_SIDED|95.0|-2.1|5.34|||t-test, 2 sided|||||5.34|-2.10|0.39
72556287|NCT05511935|144643872|SUPERIORITY||Mean Difference (Final Values)|-8.88|STANDARD_ERROR_OF_MEAN|2.84|<|0.01|TWO_SIDED|95.0|-14.52|-3.24|||t-test, 2 sided|||||-3.24|-14.52|<0.01
72556288|NCT05511935|144643873|SUPERIORITY||Mean Difference (Final Values)|-2.84|STANDARD_ERROR_OF_MEAN|4.06||0.49|TWO_SIDED|95.0|-10.9|5.23|||t-test, 2 sided|||||5.23|-10.90|0.49
72377800|NCT02446743|144264265|OTHER|Vaccine comparison at Day 4 Group 3B (V72\_41) vs Day 34 Group B\_0\_1 (V72\_41) (3 days after booster or 2nd dose)|vaccine group difference|-13.0|||||TWO_SIDED|95.0|-25.9|-3.0|||Miettinen and Nurminen score method|||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||-3.0|-25.9|
72377801|NCT02446743|144264265|OTHER|Vaccine comparison at Day 8 Group 3B (V72\_41) vs Day 38 Group B\_0\_1 (V72\_41) (7 days after booster or 2nd dose)|vaccine group difference|0.0|||||TWO_SIDED|95.0|-17.1|15.9|||Miettinen and Nurminen score method|||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||15.9|-17.1|
72377802|NCT02446743|144264265|OTHER|Vaccine comparison at Day 31 Group 3B (V72\_41) vs Day 61 Group B\_0\_1 (V72\_41) (1 month after booster or 2nd dose)|vaccine group difference|33.0|||||TWO_SIDED|95.0|20.5|45.3|||Miettinen and Nurminen score method|||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||45.3|20.5|
72377803|NCT02446743|144264265|OTHER|Vaccine comparison at Day 4 Group 3B (V72P10) vs Day 34 Group B\_0\_1 (V72P10) (3 days after booster or 2nd dose)|vaccine group difference|-25.0|||||TWO_SIDED|95.0|-40.1|-11.2|||Miettinen and Nurminen score method|||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||-11.2|-40.1|
72377804|NCT02446743|144264265|OTHER|Vaccine comparison at Day 8 Group 3B (V72P10) vs Day 38 Group B\_0\_1 (V72P10) (7 days after booster or 2nd dose)|vaccine group difference|12.0|||||TWO_SIDED|95.0|-3.9|28.1|||Miettinen and Nurminen score method|||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||28.1|-3.9|
72377805|NCT02446743|144264265|OTHER|Vaccine comparison at Day 31 Group 3B (V72P10) vs Day 61 Group B\_0\_1 (V72P10) (1 month after booster or 2nd dose)|vaccine group difference|33.0|||||TWO_SIDED|95.0|22.0|44.1|||Miettinen and Nurminen score method|||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||44.1|22.0|
72377806|NCT02446743|144264265|OTHER|Vaccine comparison at Day 4 Group 3B vs Day 34 Group B\_0\_1 (3 days after booster or 2nd dose)|vaccine group difference|-5.0|||||TWO_SIDED|95.0|-16.0|6.0|||Miettinen and Nurminen score method|||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||6.0|-16.0|
72377807|NCT02446743|144264265|OTHER|Vaccine comparison at Day 8 Group 3B vs Day 38 Group B\_0\_1 (7 days after booster or 2nd dose)|vaccine group difference|0.0|||||TWO_SIDED|95.0|-6.8|8.9|||Miettinen and Nurminen score method|||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||8.9|-6.8|
72377808|NCT02446743|144264265|OTHER|Vaccine comparison at Day 31 Group 3B vs Day 61 Group B\_0\_1 (1 month after booster or 2nd dose)|vaccine group difference|11.0|||||TWO_SIDED|95.0|5.3|16.9|||Miettinen and Nurminen score method|||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||16.9|5.3|
72377809|NCT02446743|144264265|OTHER|Vaccine comparison at Day 4 Group 3B (V72\_41) vs Day 34 Group B\_0\_1 (V72\_41) (3 days after booster or 2nd dose)|vaccine group difference|-2.0|||||TWO_SIDED|95.0|-18.0|14.1|||Miettinen and Nurminen score method|||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||14.1|-18.0|
72433602|NCT00991276|144380369|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-2.67|STANDARD_ERROR_OF_MEAN|0.99||0.0077|TWO_SIDED|95.0|-4.63|-0.72||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||-0.72|-4.63|0.0077
72377810|NCT02446743|144264265|OTHER|Vaccine comparison at Day 8 Group 3B (V72\_41) vs Day 38 Group B\_0\_1 (V72\_41) (7 days after booster or 2nd dose)|vaccine group difference|1.0|||||TWO_SIDED|95.0|-9.7|15.7|||Miettinen and Nurminen score method|||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||15.7|-9.7|
72377811|NCT02446743|144264265|OTHER|Vaccine comparison at Day 31 Group 3B (V72\_41) vs Day 61 Group B\_0\_1 (V72\_41) (1 month after booster or 2nd dose)|vaccine group difference|17.0|||||TWO_SIDED|95.0|8.2|27.8|||Miettinen and Nurminen score method|||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||27.8|8.2|
72377812|NCT02446743|144264265|OTHER|Vaccine comparison at Day 4 Group 3B (V72P10) vs Day 34 Group B\_0\_1 (V72P10) (3 days after booster or 2nd dose)|vaccine group difference|-6.0|||||TWO_SIDED|95.0|-19.1|9.1|||Miettinen and Nurminen score method|||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||9.1|-19.1|
72556289|NCT05511935|144643875|SUPERIORITY||Slope|7.71|STANDARD_ERROR_OF_MEAN|5.28||0.15|TWO_SIDED|95.0|-2.92|18.35|||Regression, Linear|||||18.35|-2.92|0.15
72377813|NCT02446743|144264265|OTHER|Vaccine comparison at Day 8 Group 3B (V72P10) vs Day 38 Group B\_0\_1 (V72P10) (7 days after booster or 2nd dose)|vaccine group difference|0.0|||||TWO_SIDED|95.0|-8.4|11.8|||Miettinen and Nurminen score method|||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||11.8|-8.4|
72377814|NCT02446743|144264265|OTHER|Vaccine comparison at Day 31 Group 3B (V72P10) vs Day 61 Group B\_0\_1 (V72P10) (1 month after booster or 2nd dose)|vaccine group difference|6.0|||||TWO_SIDED|95.0|-0.47|12.6|||Miettinen and Nurminen score method|||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||12.6|-0.47|
72377815|NCT02446743|144264266|OTHER|Vaccine Comparison Day 31 Group 3B vs Day 61 Group B\_0\_1(1 month after booster or 2nd dose)|Ratio of GMTs|3.49|||||TWO_SIDED|95.0|2.85|4.29|||ANOVA|||Adjusted geometric mean titers for H44/76 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country.||4.29|2.85|
72377816|NCT02446743|144264266|OTHER|Vaccine Comparison Day 31 Group 3B (V72\_41) vs Day 61 Group B\_0\_1 (V72\_41) (1 month after booster or 2nd dose)|Ratio of GMTs|2.73|||||TWO_SIDED|95.0|2.02|3.69|||ANOVA|||Adjusted geometric mean titers for H44/76 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country.||3.69|2.02|
72377817|NCT02446743|144264266|OTHER|Vaccine Comparison Day 31 Group 3B (V72P10) vs Day 61 Group B\_0\_1 (V72P10) (1 month after booster or 2nd dose)|Ratio of GMTs|4.46|||||TWO_SIDED|95.0|3.38|5.88|||ANOVA|||Adjusted geometric mean titers for H44/76 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country.||5.88|3.38|
72377818|NCT02446743|144264266|OTHER|Vaccine Comparison Day 31 Group 3B vs Day 61 Group B\_0\_1(1 month after booster or 2nd dose)|Ratio of GMTs|8.18|||||TWO_SIDED|95.0|6.51|10.0|||ANOVA|||Adjusted geometric mean titers for 5/99 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country||10|6.51|
72377819|NCT02446743|144264266|OTHER|Vaccine Comparison Day 31 Group 3B (V72\_41) vs Day 61 Group B\_0\_1 (V72\_41) (1 month after booster or 2nd dose)|Ratio of GMTs|9.58|||||TWO_SIDED|95.0|7.17|13.0|||ANOVA|||Adjusted geometric mean titers for 5/99 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country.||13|7.17|
72377820|NCT02446743|144264266|OTHER|Vaccine Comparison Day 31 Group 3B (V72P10) vs Day 61 Group B\_0\_1 (V72P10) (1 month after booster or 2nd dose)|Ratio of GMTs|6.9|||||TWO_SIDED|95.0|4.82|9.87|||ANOVA|||Adjusted geometric mean titers for 5/99 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country.||9.87|4.82|
72377821|NCT02446743|144264266|OTHER|Vaccine Comparison Day 31 Group 3B vs Day 61 Group B\_0\_1(1 month after booster or 2nd dose)|Ratio of GMTs|2.58|||||TWO_SIDED|95.0|1.98|3.36|||ANOVA|||Adjusted geometric mean titers for NZ98/254 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country||3.36|1.98|
72377822|NCT02446743|144264266|OTHER|Vaccine Comparison Day 31 Group 3B (V72\_41) vs Day 61 Group B\_0\_1 (V72\_41) (1 month after booster or 2nd dose)|Ratio of GMTs|2.65|||||TWO_SIDED|95.0|1.89|3.73|||ANOVA|||Adjusted geometric mean titers for NZ98/254 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country.||3.73|1.89|
72377823|NCT02446743|144264266|OTHER|Vaccine Comparison Day 31 Group 3B (V72P10) vs Day 61 Group B\_0\_1 (V72P10) (1 month after booster or 2nd dose)|Ratio of GMTs|2.51|||||TWO_SIDED|95.0|1.67|3.78|||ANOVA|||Adjusted geometric mean titers for NZ98/254 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country.||3.78|1.67|
72556290|NCT05511935|144643876|SUPERIORITY||Slope|0.43|STANDARD_ERROR_OF_MEAN|4.19||0.92|TWO_SIDED|95.0|-8.13|8.99|||Regression, Linear|||||8.99|-8.13|0.92
72377824|NCT02446743|144264266|OTHER|Vaccine Comparison Day 31 Group 3B vs Day 61 Group B\_0\_1(1 month after booster or 2nd dose)|Ratio of GMTs|1.9|||||TWO_SIDED|95.0|1.52|2.36|||ANOVA|||Adjusted geometric mean titers for M10713 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country||2.36|1.52|
72377825|NCT02446743|144264266|OTHER|Vaccine Comparison Day 31 Group 3B (V72\_41) vs Day 61 Group B\_0\_1 (V72\_41) (1 month after booster or 2nd dose)|Ratio of GMTs|1.88|||||TWO_SIDED|95.0|1.37|2.59|||ANOVA|||Adjusted geometric mean titers for M10713 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country.||2.59|1.37|
72556291|NCT05511935|144643877|SUPERIORITY||Slope|7.66|STANDARD_ERROR_OF_MEAN|5.81||0.2|TWO_SIDED|95.0|-4.17|19.49|||Regression, Linear|||||19.49|-4.17|0.20
72556292|NCT05511935|144643878|SUPERIORITY||Slope|-9.29|STANDARD_ERROR_OF_MEAN|10.74||0.39|TWO_SIDED|95.0|-31.15|12.56|||Regression, Linear|||||12.56|-31.15|0.39
72556293|NCT05090839|144643886|EQUIVALENCE|The 95% confidence interval is used to assess the difference between the means of the 2 x 2 (English vs. Spanish) and (Trauma vs. Non-trauma) writing groups.|variance explained by the IV.|0.072|||<|0.05|TWO_SIDED|95.0|0.0|0.234|||ANOVA|||||.234|.0000|<0.05
72618441|NCT01691482|144767947|SUPERIORITY_OR_OTHER||Slope|0.062|STANDARD_ERROR_OF_MEAN|0.0046||||95.0|0.053|0.071|||||Treatment: I+A. A mixed model analysis, with period, treatment (A+I, I+A, Albuterol alone, Ipratropium alone), FEV1 Baseline, smoking status at Screening, and center fitted as fixed effects and participant as a random effect was used.|||0.071|0.053|
72377826|NCT02446743|144264266|OTHER|Vaccine Comparison Day 31 Group 3B (V72P10) vs Day 61 Group B\_0\_1 (V72P10) (1 month after booster or 2nd dose)|Ratio of GMTs|1.91|||||TWO_SIDED|95.0|1.41|2.58|||ANOVA|||Adjusted geometric mean titers for M10713 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country.||2.58|1.41|
72377827|NCT02446743|144264268|OTHER|3 Days Post Booster/Second Vaccination. Four-fold Increase (Group 3B vs. Group B\_0\_1) Difference|Vaccine group difference|-2.0|||||TWO_SIDED|95.0|-7.5|1.8|||Miettinen and Nurminen score method|||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||1.8|-7.5|
72377828|NCT02446743|144264268|OTHER|7 Days Post Booster/Second Vaccination. Four-fold Increase (Group 3B vs. Group B\_0\_1) Difference|vaccine group difference|53.0|||||TWO_SIDED|95.0|42.1|62.5|||Miettinen and Nurminen score method|||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||62.5|42.1|
72377829|NCT02446743|144264268|OTHER|1 Month Post Booster/Second Vaccination. Four-fold Increase (Group 3B vs. Group B\_0\_1) Difference|vaccine group difference|58.0|||||TWO_SIDED|95.0|50.5|64.7|||Miettinen and Nurminen score method|||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||64.7|50.5|
72377830|NCT02446743|144264268|OTHER|3 Days Post Booster/Second Vaccination. Four-fold Increase \[Group 3B (V72\_41) vs. Group B\_0\_1 (V72\_41)\] Difference|vaccine group difference|-4.0|||||TWO_SIDED|95.0|-14.1|2.0|||Miettinen and Nurminen score method|||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||2.0|-14.1|
72377831|NCT02446743|144264268|OTHER|7 Days Post Booster/Second Vaccination. Four-fold Increase \[Group 3B (V72\_41) vs. Group B\_0\_1 (V72\_41)\] Difference|vaccine group difference|44.0|||||TWO_SIDED|95.0|28.1|58.5|||Miettinen and Nurminen score method|||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||58.5|28.1|
72377832|NCT02446743|144264268|OTHER|1 month Post Booster/Second Vaccination. Four-fold Increase \[Group 3B (V72\_41) vs. Group B\_0\_1 (V72\_41)\] Difference|vaccine group difference|44.0|||||TWO_SIDED|95.0|32.7|54.1|||Miettinen and Nurminen score method|||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||54.1|32.7|
72377833|NCT02446743|144264268|OTHER|3 Days Post Booster/Second Vaccination. Four-fold Increase \[Group 3B (V72P10) vs. Group B\_0\_1 (V72P10)\] Difference|vaccine group difference|0.0|||||TWO_SIDED|95.0|-8.0|4.8|||Miettinen and Nurminen score method|||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||4.8|-8.0|
72377834|NCT02446743|144264268|OTHER|7 Days Post Booster/Second Vaccination. Four-fold Increase \[Group 3B (V72P10) vs. Group B\_0\_1 (V72P10)\] Difference|Vaccine group difference|60.0|||||TWO_SIDED|95.0|45.0|71.5|||Miettinen and Nurminen score method|||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||71.5|45.0|
72377835|NCT02446743|144264268|OTHER|1 month Post Booster/Second Vaccination. Four-fold Increase \[Group 3B (V72P10) vs. Group B\_0\_1 (V72P10)\] Difference|vaccine group difference|71.0|||||TWO_SIDED|95.0|61.2|78.5|||Miettinen and Nurminen score method|||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||78.5|61.2|
72377836|NCT02446743|144264268|OTHER|3 Days Post Booster/Second Vaccination. Four-fold Increase (Group 3B vs. Group B\_0\_1) Difference|vaccine group difference|-1.0|||||TWO_SIDED|95.0|-9.1|4.0|||Miettinen and Nurminen score method|||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||4|-9.1|
72377837|NCT02446743|144264268|OTHER|7 Days Post Booster/Second Vaccination. Four-fold Increase (Group 3B vs. Group B\_0\_1) Difference|vaccine group difference|37.0|||||TWO_SIDED|95.0|27.0|48.1|||Miettinen and Nurminen score method|||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||48.1|27.0|
72556294|NCT05090839|144643888|EQUIVALENCE|The 95% confidence interval is used to assess the difference between the means of the 2 x 2 (English vs. Spanish) and (Trauma vs. Non-trauma) writing groups.|Mean Difference (Final Values)|0.358|||<|0.05|TWO_SIDED|95.0|0.0|0.554|||ANOVA|||This is a comparison that is specific to the contrast of visualizing traumatic versus stressful events.||.554|0|<0.05
72618442|NCT01691482|144767951|SUPERIORITY_OR_OTHER||Adjusted Mean|0.058|STANDARD_ERROR_OF_MEAN|0.0046||||95.0|0.049|0.067|||||Treatment: A/S alone. A mixed model analysis, with period, treatment (A+I, I+A, Albuterol alone, Ipratropium alone), FEV1 Baseline, smoking status at Screening, and center fitted as fixed effects and participant as a random effect was used.|||0.067|0.049|
72618443|NCT01691482|144767951|SUPERIORITY_OR_OTHER||Adjusted Mean|0.071|STANDARD_ERROR_OF_MEAN|0.0046||||95.0|0.062|0.08|||||Treatment: ipratropium alone. A mixed model analysis, with period, treatment (A+I, I+A, Albuterol alone, Ipratropium alone), FEV1 Baseline, smoking status at Screening, and center fitted as fixed effects and participant as a random effect was used.|||0.080|0.062|
72556295|NCT05090839|144643889|EQUIVALENCE|The 95% confidence interval is used to assess the difference between the means of the 2 x 2 (English vs. Spanish) and (Trauma vs. Non-trauma) writing groups.|Mean Difference (Final Values)|0.51|||<|0.05|TWO_SIDED|95.0|0.0|0.676|||ANOVA|||||.676|.000|<0.05
72618444|NCT01691482|144767951|SUPERIORITY_OR_OTHER||Adjusted Mean|0.053|STANDARD_ERROR_OF_MEAN|0.0046||||95.0|0.044|0.062|||||Treatment: A+I. A mixed model analysis, with period, treatment (A+I, I+A, Albuterol alone, Ipratropium alone), FEV1 Baseline, smoking status at Screening, and center fitted as fixed effects and participant as a random effect was used.|||0.062|0.044|
72618445|NCT01691482|144767951|SUPERIORITY_OR_OTHER||Adjusted Mean|0.062||||||95.0|0.053|0.071|||||Treatment: I+A. A mixed model analysis, with period, treatment (A+I, I+A, Albuterol alone, Ipratropium alone), FEV1 Baseline, smoking status at Screening, and center fitted as fixed effects and participant as a random effect was used.|||0.071|0.053|
72618446|NCT01691482|144767952|SUPERIORITY_OR_OTHER||Adjusted Mean|0.067|STANDARD_ERROR_OF_MEAN|0.0045||||95.0|0.058|0.076|||||Treatment: A/S alone. A mixed model analysis, with period, treatment (A+I, I+A, Albuterol alone, Ipratropium alone), IC Baseline, smoking status at Screening, and center fitted as fixed effects and participant as a random effect was used.|||0.076|0.058|
72618447|NCT01691482|144767952|SUPERIORITY_OR_OTHER||Adjusted Mean|0.07|STANDARD_ERROR_OF_MEAN|0.0045||||95.0|0.061|0.079|||||Treatment: ipratropium alone. A mixed model analysis, with period, treatment (A+I, I+A, Albuterol alone, Ipratropium alone), IC Baseline, smoking status at Screening, and center fitted as fixed effects and participant as a random effect was used.|||0.079|0.061|
72618448|NCT01691482|144767952|SUPERIORITY_OR_OTHER||Adjusted Mean|0.069|STANDARD_ERROR_OF_MEAN|0.0045||||95.0|0.06|0.078|||||Treatment: A+I. A mixed model analysis, with period, treatment (A+I, I+A, Albuterol alone, Ipratropium alone), IC Baseline, smoking status at Screening, and center fitted as fixed effects and participant as a random effect was used.|||0.078|0.060|
72618449|NCT01691482|144767952|SUPERIORITY_OR_OTHER||Adjusted Mean|0.064|STANDARD_ERROR_OF_MEAN|0.0045||||95.0|0.055|0.073|||||Treatment: I+A. A mixed model analysis, with period, treatment (A+I, I+A, Albuterol alone, Ipratropium alone), IC Baseline, smoking status at Screening, and center fitted as fixed effects and participant as a random effect was used.|||0.073|0.055|
72618450|NCT01691482|144767953|SUPERIORITY_OR_OTHER||Adjusted Mean|0.228|STANDARD_ERROR_OF_MEAN|0.014||||95.0|0.2|0.255|||||Treatment: A/S alone. A mixed model analysis, with period, treatment (A+I, I+A, Albuterol alone, Ipratropium alone), IC Baseline, smoking status at Screening, and center fitted as fixed effects and participant as a random effect was used.|||0.255|0.200|
72618451|NCT01691482|144767953|SUPERIORITY_OR_OTHER||Adjusted Mean|0.231|STANDARD_ERROR_OF_MEAN|0.014||||95.0|0.203|0.258|||||Treatment: ipratropium alone. A mixed model analysis, with period, treatment (A+I, I+A, Albuterol alone, Ipratropium alone), IC Baseline, smoking status at Screening, and center fitted as fixed effects and participant as a random effect was used.|||0.258|0.203|
72618452|NCT01691482|144767953|SUPERIORITY_OR_OTHER||Adjusted Mean|0.232|STANDARD_ERROR_OF_MEAN|0.014||||95.0|0.204|0.259|||||Treatment: A+I. A mixed model analysis, with period, treatment (A+I, I+A, Albuterol alone, Ipratropium alone), IC Baseline, smoking status at Screening, and center fitted as fixed effects and participant as a random effect was used.|||0.259|0.204|
72618453|NCT01691482|144767953|SUPERIORITY_OR_OTHER||Adjusted Mean|0.217|STANDARD_ERROR_OF_MEAN|0.014||||95.0|0.19|0.245|||||Treatment: I+A. A mixed model analysis, with period, treatment (A+I, I+A, Albuterol alone, Ipratropium alone), IC Baseline, smoking status at Screening, and center fitted as fixed effects and participant as a random effect was used.|||0.245|0.190|
72618454|NCT00395512|144767954|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.56|||<|0.001|TWO_SIDED|95.0|-0.78|-0.33||ANCOVA model with treatment and geographic region as class variables and baseline HbA1c as a covariate.|ANCOVA|||The primary efficacy variable was defined as change from Baseline in HbA1c level at Week 26. The null hypothesis was that the average change from Baseline in HbA1c at Week 26 for the A25 + P30 group would be equal to the average changes for the P30 alone and A25 alone groups; further, under the null hypothesis, the average change from Baseline in HbA1c at Week 26 for the A12.5 + P30 group was equal to the average change for the P30 alone group.||-0.33|-0.78|<0.001
72618455|NCT00395512|144767954|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.75|||<|0.001|TWO_SIDED|95.0|-0.98|-0.53||ANCOVA model with treatment and geographic region as class variables and baseline HbA1c as a covariate.|ANCOVA|||||-0.53|-0.98|<0.001
72618456|NCT00395512|144767954|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4|||<|0.001|TWO_SIDED|95.0|-0.63|-0.18||ANCOVA model with treatment and geographic region as class variables and baseline HbA1c as a covariate.|ANCOVA|||||-0.18|-0.63|<0.001
72618457|NCT00395512|144767955|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.33||||0.003|TWO_SIDED|95.0|-0.55|-0.12|||ANCOVA|ANCOVA model with treatment and geographic region as class variables and baseline HbA1c as a covariate.||Comparison of change from Baseline at Week 20 between Pioglitazone 30 mg and Alogliptin 12.5 mg + Pioglitazone 30 mg.||-0.12|-0.55|0.003
72618458|NCT00395512|144767955|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.52|||<|0.001|TWO_SIDED|95.0|-0.74|-0.3|||ANCOVA|ANCOVA model with treatment and geographic region as class variables and baseline HbA1c as a covariate.||Comparison of change from Baseline at Week 20 between Pioglitazone 30 mg and Alogliptin 25 mg + Pioglitazone 30 mg.||-0.30|-0.74|<0.001
72618459|NCT00395512|144767955|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.73|||<|0.001|TWO_SIDED|95.0|-0.94|-0.51|||ANCOVA|ANCOVA model with treatment and geographic region as class variables and baseline HbA1c as a covariate.||Comparison of change from Baseline at Week 20 between Alogliptin 25 mg and Alogliptin 25 mg + Pioglitazone 30 mg.||-0.51|-0.94|<0.001
72618460|NCT00395512|144767956|SUPERIORITY_OR_OTHER||LS Mean Difference|-11.2||||0.017|TWO_SIDED|95.0|-20.3|-2.0|||ANCOVA|P-value is from an ANCOVA model with treatment and geographic region as class variables and Baseline fasting plasma glucose as covariate.||Comparison of change from Baseline in fasting plasma glucose at Week 26 between Pioglitazone 30 mg and Alogliptin 12.5 mg + Pioglitazone 30 mg.||-2.0|-20.3|0.017
72618461|NCT00395512|144767956|SUPERIORITY_OR_OTHER||LS Mean Difference|-12.9||||0.006|TWO_SIDED|95.0|-22.0|-3.8|||ANCOVA|P-value is from an ANCOVA model with treatment and geographic region as class variables and Baseline fasting plasma glucose as covariate.||Comparison of change from Baseline in fasting plasma glucose at Week 26 between Pioglitazone 30 mg and Alogliptin 25 mg + Pioglitazone 30 mg.||-3.8|-22.0|0.006
72618462|NCT00395512|144767956|SUPERIORITY_OR_OTHER||LS Mean Difference|-24.5|||<|0.001|TWO_SIDED|95.0|-33.5|-15.4|||ANCOVA|P-value is from an ANCOVA model with treatment and geographic region as class variables and Baseline fasting plasma glucose as covariate.||Comparison of change from Baseline in fasting plasma glucose at Week 26 between Alogliptin 25 mg and Alogliptin 25 mg + Pioglitazone 30 mg.||-15.4|-33.5|<0.001
72377838|NCT02446743|144264268|OTHER|1 Month Post Booster/Second Vaccination. Four-fold Increase (Group 3B vs. Group B\_0\_1) Difference|Vaccine group difference|33.0|||||TWO_SIDED|95.0|25.2|40.4|||Miettinen and Nurminen score method|||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||40.4|25.2|
72377839|NCT02446743|144264268|OTHER|3 Days Post Booster/Second Vaccination. Four-fold Increase \[Group 3B (V72\_41) vs. Group B\_0\_1 (V72\_41)\] Difference|vaccine group difference|2.0|||||TWO_SIDED|95.0|-8.7|10.2|||Miettinen and Nurminen score method|||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||10.2|-8.7|
72377840|NCT02446743|144264268|OTHER|7 Days Post Booster/Second Vaccination. Four-fold Increase \[Group 3B (V72\_41) vs. Group B\_0\_1 (V72\_41)\] Difference|vaccine group difference|43.0|||||TWO_SIDED|95.0|27.7|58.6|||Miettinen and Nurminen score method|||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||58.6|27.7|
72377841|NCT02446743|144264268|OTHER|1 month Post Booster/Second Vaccination. Four-fold Increase \[Group 3B (V72\_41) vs. Group B\_0\_1 (V72\_41)\] Difference|vaccine group difference|42.0|||||TWO_SIDED|95.0|31.1|53.0|||Miettinen and Nurminen score method|||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||53.0|31.1|
72377842|NCT02446743|144264268|OTHER|3 Days Post Booster/Second Vaccination. Four-fold Increase \[Group 3B (V72P10) vs. Group B\_0\_1 (V72P10)\] Difference|vaccine group difference|-6.0|||||TWO_SIDED|95.0|-19.2|0.9|||Miettinen and Nurminen score method|||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||0.9|-19.2|
72377843|NCT02446743|144264268|OTHER|7 Days Post Booster/Second Vaccination. Four-fold Increase \[Group 3B (V72P10) vs. Group B\_0\_1 (V72P10)\] Difference|vaccine group difference|32.0|||||TWO_SIDED|95.0|18.2|47.0|||Miettinen and Nurminen score method|||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||47.0|18.2|
72377844|NCT02446743|144264268|OTHER|1 month Post Booster/Second Vaccination. Four-fold Increase \[Group 3B (V72P10) vs. Group B\_0\_1 (V72P10)\] Difference|vaccine group difference|24.0|||||TWO_SIDED|95.0|13.2|34.4|||Miettinen and Nurminen score method|||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||34.4|13.2|
72377845|NCT02446743|144264268|OTHER|3 Days Post Booster/Second Vaccination. Four-fold Increase (Group 3B vs. Group B\_0\_1) Difference|vaccine group difference|0.0|||||TWO_SIDED|95.0|-4.7|3.4|||Miettinen and Nurminen score method|||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||3.4|-4.7|
72377846|NCT02446743|144264268|OTHER|7 Days Post Booster/Second Vaccination. Four-fold Increase (Group 3B vs. Group B\_0\_1) Difference|Vaccine group difference|36.0|||||TWO_SIDED|95.0|25.6|45.7|||Miettinen and Nurminen score method|||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||45.7|25.6|
72377847|NCT02446743|144264268|OTHER|1 Month Post Booster/Second Vaccination. Four-fold Increase (Group 3B vs. Group B\_0\_1) Difference|vaccine group difference|54.0|||||TWO_SIDED|95.0|45.2|61.1|||Miettinen and Nurminen score method|||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||61.1|45.2|
72377848|NCT02446743|144264268|OTHER|3 Days Post Booster/Second Vaccination. Four-fold Increase \[Group 3B (V72\_41) vs. Group B\_0\_1 (V72\_41)\] Difference|vaccine group difference|0.0|||||TWO_SIDED|95.0|-8.4|5.0|||Miettinen and Nurminen score method|||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||5.0|-8.4|
72377849|NCT02446743|144264268|OTHER|7 Days Post Booster/Second Vaccination. Four-fold Increase \[Group 3B (V72\_41) vs. Group B\_0\_1 (V72\_41)\] Difference|vaccine group difference|29.0|||||TWO_SIDED|95.0|12.1|43.0|||Miettinen and Nurminen score method|||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||43.0|12.1|
72377850|NCT02446743|144264268|OTHER|1 month Post Booster/Second Vaccination. Four-fold Increase \[Group 3B (V72\_41) vs. Group B\_0\_1 (V72\_41)\] Difference|Vaccine group difference|46.0|||||TWO_SIDED|95.0|33.6|57.1|||Miettinen and Nurminen score method|||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/154 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||57.1|33.6|
72618463|NCT04576949|144767995|SUPERIORITY||Odds Ratio (OR)|8.0|||<|0.0001|TWO_SIDED|95.0|3.94|16.25||Two-sided, calculated by exact computations with clinical site as a stratifier.|exact computations||Stratified by site|Abstinence from Week 3 to Week 6||16.25|3.94|< 0.0001
72618464|NCT04576949|144767995|SUPERIORITY||Marginal Difference in Proportions|0.21|||<|0.0001|TWO_SIDED|95.0|0.16|0.25||p-value for difference in proportions|Cochran-Mantel-Haenszel|||||0.25|0.16|<0.0001
72618465|NCT04576949|144767996|SUPERIORITY||Odds Ratio (OR)|6.29|||<|0.0001|TWO_SIDED|95.0|3.69|11.57||Two-sided, calculated by exact computations with clinical site as a stratifier.|exact computations||Stratified by site|Abstinence from Week 9 to Week 12||11.57|3.69|< 0.0001
72377851|NCT02446743|144264268|OTHER|3 Days Post Booster/Second Vaccination. Four-fold Increase \[Group 3B (V72P10) vs. Group B\_0\_1 (V72P10)\] Difference|Vaccine group difference|0.0|||||TWO_SIDED|95.0|-8.0|5.4|||Miettinen and Nurminen score method|||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||5.4|-8.0|
72377852|NCT02446743|144264268|OTHER|7 Days Post Booster/Second Vaccination. Four-fold Increase \[Group 3B (V72P10) vs. Group B\_0\_1 (V72P10)\] Difference|Vaccine group difference|42.0|||||TWO_SIDED|95.0|27.8|54.5|||Miettinen and Nurminen score method|||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||54.5|27.8|
72377853|NCT02446743|144264268|OTHER|1 month Post Booster/Second Vaccination. Four-fold Increase \[Group 3B (V72P10) vs. Group B\_0\_1 (V72P10)\] Difference|vaccine group difference|60.0|||||TWO_SIDED|95.0|47.9|69.6|||Miettinen and Nurminen score method|||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||69.6|47.9|
72377854|NCT02446743|144264268|OTHER|3 Days Post Booster/Second Vaccination. Four-fold Increase (Group 3B vs. Group B\_0\_1) Difference|vaccine group difference|3.0|||||TWO_SIDED|95.0|-1.1|5.4|||Miettinen and Nurminen score method|||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||5.4|-1.1|
72377855|NCT02446743|144264268|OTHER|7 Days Post Booster/Second Vaccination. Four-fold Increase (Group 3B vs. Group B\_0\_1) Difference|vaccine group difference|28.0|||||TWO_SIDED|95.0|19.1|34.9|||Miettinen and Nurminen score method|||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||34.9|19.1|
72377856|NCT02446743|144264268|OTHER|1 Month Post Booster/Second Vaccination. Four-fold Increase (Group 3B vs. Group B\_0\_1) Difference|vaccine group difference|39.0|||||TWO_SIDED|95.0|31.6|46.6|||Miettinen and Nurminen score method|||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||46.6|31.6|
72377857|NCT02446743|144264268|OTHER|3 Days Post Booster/Second Vaccination. Four-fold Increase \[Group 3B (V72\_41) vs. Group B\_0\_1 (V72\_41)\] Difference|Vaccine group difference|2.0|||||TWO_SIDED|95.0|-4.9|6.7|||Miettinen and Nurminen score method|||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||6.7|-4.9|
72377858|NCT02446743|144264268|OTHER|7 Days Post Booster/Second Vaccination. Four-fold Increase \[Group 3B (V72\_41) vs. Group B\_0\_1 (V72\_41)\] Difference|Vaccine group difference|25.0|||||TWO_SIDED|95.0|9.7|37.1|||Miettinen and Nurminen score method|||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||37.1|9.7|
72377859|NCT02446743|144264268|OTHER|1 month Post Booster/Second Vaccination. Four-fold Increase \[Group 3B (V72\_41) vs. Group B\_0\_1 (V72\_41)\] Difference|Vaccine group difference|37.0|||||TWO_SIDED|95.0|25.1|47.0|||Miettinen and Nurminen score method|||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||47.0|25.1|
72377860|NCT02446743|144264268|OTHER|3 Days Post Booster/Second Vaccination. Four-fold Increase \[Group 3B (V72P10) vs. Group B\_0\_1 (V72P10)\] Difference|Vaccine group difference|3.0|||||TWO_SIDED|95.0|-3.9|7.6|||Miettinen and Nurminen score method|||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||7.6|-3.9|
72377861|NCT02446743|144264268|OTHER|7 Days Post Booster/Second Vaccination. Four-fold Increase \[Group 3B (V72P10) vs. Group B\_0\_1 (V72P10)\] Difference|Vaccine group difference|28.0|||||TWO_SIDED|95.0|20.2|36.6|||Miettinen and Nurminen score method|||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||36.6|20.2|
72377862|NCT02446743|144264268|OTHER|1 month Post Booster/Second Vaccination. Four-fold Increase \[Group 3B (V72P10) vs. Group B\_0\_1 (V72P10)\] Difference|Vaccine group difference|42.0|||||TWO_SIDED|95.0|31.0|51.9|||Miettinen and Nurminen score method|||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||51.9|31.0|
72377863|NCT03718299|144264276|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||Week 52||||<0.001
72377864|NCT03718299|144264277|SUPERIORITY|||||||0.011|||||||t-test, 2 sided|||||||0.011
72377865|NCT03718299|144264278|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
72377866|NCT03718299|144264279|SUPERIORITY||Clopper-Pearson|62.2|||||TWO_SIDED|95.0|46.5|76.2||||||||76.2|46.5|
72377867|NCT03718299|144264280|SUPERIORITY||Clopper-Pearson|93.3|||||TWO_SIDED|95.0|81.7|98.6||||||||98.6|81.7|
72377868|NCT03718299|144264281|SUPERIORITY||Clopper-Pearson|78.9|||||TWO_SIDED|95.0|62.7|90.4||||||||90.4|62.7|
72377869|NCT03718299|144264282|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
72618466|NCT04576949|144767996|SUPERIORITY||Marginal Difference in Proportions|0.26|||<|0.0001|TWO_SIDED|95.0|0.2|0.3||p-value for difference in proportions|Cochran-Mantel-Haenszel|||||0.30|0.20|<0.0001
72377870|NCT03718299|144264283|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
72377871|NCT03718299|144264284|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
72377872|NCT03718299|144264285|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
72377873|NCT03718299|144264286|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
72377874|NCT03718299|144264287|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
72377875|NCT03718299|144264288|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
72377876|NCT03718299|144264289|SUPERIORITY||Mean (Clopper-Pearson)|24.4|||||TWO_SIDED|95.0|12.9|39.5||||||||39.5|12.9|
72377877|NCT03718299|144264290|SUPERIORITY||Mean (Clopper-Pearson)|17.8|||||TWO_SIDED|95.0|8.0|32.1||||||||32.1|8.0|
72377878|NCT03718299|144264291|SUPERIORITY||Clopper-Pearson|48.9|||||TWO_SIDED|95.0|33.7|64.2||||||||64.2|33.7|
72377879|NCT03718299|144264292|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||Total Activity Impairment||||<0.001
72377880|NCT03718299|144264292|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||Total Work Productivity Impairment||||<0.001
72377881|NCT03718299|144264293|SUPERIORITY||Mean|79.5|STANDARD_DEVIATION|20.06|||TWO_SIDED|||||||||Treatment Satisfaction Questionnaire for Medication over time- Effectiveness||||
72377882|NCT03718299|144264293|SUPERIORITY||||||<|0.001|||||||Exact binomial test|||Treatment Satisfaction Questionnaire for Medication over time-Side Effects||||<0.001
72377883|NCT03718299|144264293|SUPERIORITY||Mean|82.2|STANDARD_DEVIATION|16.35|||TWO_SIDED|||||||||Treatment Satisfaction Questionnaire for Medication over time - Convenience||||
72377884|NCT03718299|144264293|SUPERIORITY||Mean|81.9|STANDARD_DEVIATION|20.47|||TWO_SIDED|||||||||Treatment Satisfaction Questionnaire for Medication over time - Global Satisfaction||||
72377885|NCT03718299|144264294|SUPERIORITY||Mean|8.7|STANDARD_DEVIATION|2.01|||TWO_SIDED|||||||||Improvement in Symptoms||||
72618467|NCT04576949|144767997|SUPERIORITY||Odds Ratio (OR)|3.67||||0.0016|TWO_SIDED|95.0|1.5|10.24||Two-sided, calculated by exact computations with clinical site as a stratifier.|exact computations|||Abstinence from Week 6 to Week 24|Stratified by site|10.24|1.50|0.0016
72618468|NCT04576949|144767997|SUPERIORITY||Marginal Difference in Proportions|0.06||||0.0015|TWO_SIDED|95.0|0.03|0.09||p-value for difference in proportions|Cochran-Mantel-Haenszel|||||0.09|0.03|0.0015
72377886|NCT03718299|144264294|SUPERIORITY||Mean|8.3|STANDARD_DEVIATION|2.3|||TWO_SIDED|||||||||Speed of Symptom Improvement||||
72377887|NCT03718299|144264294|SUPERIORITY||Mean|9.1|STANDARD_DEVIATION|1.7|||TWO_SIDED|||||||||Frequency of Taking Medication||||
72377888|NCT03718299|144264294|SUPERIORITY||Mean|9.6|STANDARD_DEVIATION|0.68|||TWO_SIDED|||||||||Side Effects||||
72377889|NCT03718299|144264295|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
72377890|NCT04972630|144264324|OTHER|Comparison via 95% confidence interval|Mean Difference (Final Values)|0.6|||||TWO_SIDED|95.0||||||||Baseline control vs. intervention||||
72377891|NCT04972630|144264324|OTHER|Comparison via 95% confidence interval|Mean Difference (Final Values)|0.1|||||TWO_SIDED|95.0||||||||Week 4 control vs. intervention||||
72377892|NCT04972630|144264324|OTHER|Comparison via 95% confidence interval|Mean Difference (Final Values)|1.3|||||TWO_SIDED|95.0||||||||Week 12, control vs. intervention||||
72377893|NCT04972630|144264324|OTHER|Comparison via 95% confidence interval|Mean Difference (Final Values)|1.9|||||TWO_SIDED|95.0||||||||Week 24, control vs. intervention||||
72618469|NCT04576949|144767998|SUPERIORITY||Odds Ratio (OR)|5.32|||<|0.0001|TWO_SIDED|95.0|2.81|11.09||Two-sided, calculated by exact computations with clinical site as a stratifier.|exact computations||Stratified by site|Abstinence from Week 12 to Week 24||11.09|2.81|< 0.0001
72377894|NCT04972630|144264325|OTHER|Comparison via 95% confidence interval|Mean Difference (Final Values)|0.5|||||TWO_SIDED|95.0||||||||||||
72377895|NCT04972630|144264326|OTHER|Comparison via 95% confidence interval|Mean Difference (Final Values)|1.5|||||TWO_SIDED|95.0||||||||||||
72377896|NCT04972630|144264327|OTHER|Comparison via 95% confidence interval|Mean Difference (Final Values)|-1.7|||||TWO_SIDED|95.0||||||||||||
72377897|NCT04972630|144264328|OTHER|Comparison via 95% confidence interval|Mean Difference (Final Values)|-2.8|||||TWO_SIDED|95.0||||||||||||
72377898|NCT04972630|144264329|OTHER|Comparison via 95% confidence interval|Mean Difference (Final Values)|-9.2|||||TWO_SIDED|95.0||||||||||||
72377899|NCT04972630|144264330|OTHER|Comparison via 95% confidence interval|Mean Difference (Final Values)|3.2|||||TWO_SIDED|95.0||||||||||||
72377900|NCT04972630|144264331|OTHER|Comparison via 95% confidence interval|Mean Difference (Final Values)|-5.0|||||TWO_SIDED|95.0||||||||||||
72377901|NCT04972630|144264332|OTHER|Comparison via 95% confidence interval|Mean Difference (Final Values)|-4.5|||||TWO_SIDED|95.0||||||||||||
72377902|NCT04972630|144264333|OTHER|Comparison via 95% confidence interval|Mean Difference (Final Values)|-6.4|||||TWO_SIDED|95.0||||||||||||
72377903|NCT04972630|144264334|OTHER|Comparison via 95% confidence interval|Mean Difference (Final Values)|-3.8|||||TWO_SIDED|95.0||||||||||||
72377904|NCT04972630|144264335|OTHER|Comparison via 95% confidence interval|Mean Difference (Final Values)|-16.7|||||TWO_SIDED|95.0||||||||||||
72377905|NCT04972630|144264336|OTHER|Comparison via 95% confidence interval|Mean Difference (Final Values)|0.5|||||TWO_SIDED|95.0||||||||||||
72377906|NCT04972630|144264337|OTHER|Comparison via 95% confidence interval|Mean Difference (Final Values)|0.4|||||TWO_SIDED|95.0||||||||Baseline, control vs. intervention||||
72377907|NCT04972630|144264337|OTHER|Comparison via 95% confidence interval|Mean Difference (Final Values)|5.5|||||TWO_SIDED|95.0||||||||Week 4, control vs. intervention||||
72377908|NCT04972630|144264337|OTHER|Comparison via 95% confidence interval|Mean Difference (Final Values)|0.9|||||TWO_SIDED|95.0||||||||Week 12, control vs. intervention||||
72377909|NCT04972630|144264337|OTHER|Comparison via 95% confidence interval|Mean Difference (Final Values)|2.6|||||TWO_SIDED|95.0||||||||Week 24, control vs. intervention||||
72377910|NCT04972630|144264338|OTHER|Comparison via 95% confidence interval|Mean Difference (Final Values)|-2.2|||||TWO_SIDED|95.0||||||||Baseline, control vs. intervention||||
72377911|NCT04972630|144264338|OTHER|Comparison via 95% confidence interval|Mean Difference (Final Values)|0.5|||||TWO_SIDED|95.0||||||||Week 4, control vs. intervention||||
72377912|NCT04972630|144264338|OTHER|Comparison via 95% confidence interval|Mean Difference (Final Values)|-0.9|||||TWO_SIDED|95.0||||||||Week 12, control vs. intervention||||
72377913|NCT04972630|144264338|OTHER|Comparison via 95% confidence interval|Mean Difference (Final Values)|-0.8|||||TWO_SIDED|95.0||||||||Week 24, control vs. intervention||||
72377914|NCT00075270|144264339|SUPERIORITY_OR_OTHER||Hazard Ratio, log|0.87||||0.142|TWO_SIDED|95.0|0.72|1.05||P-value from stratified log-rank test, stratifying for stage of disease and site of disease at screening|Log Rank||The estimate of the treatment hazard ratio is based on the log-rank test.|||1.05|0.72|0.142
72377915|NCT00075270|144264340|SUPERIORITY_OR_OTHER||Hazard Ratio, log|0.82||||0.094|TWO_SIDED|95.0|0.65|1.04||P-value from stratified log-rank test, stratifying for stage of disease and site of disease at screening|Log Rank||The estimate of the treatment hazard ratio was based on the log-rank test.|||1.04|0.65|0.094
72377916|NCT03390842|144264377|SUPERIORITY||Difference in % of subjects|24.9|||=|0.0015|TWO_SIDED|95.0|10.2|38.7|||Fisher Exact|||% Subjects Who Met Endpoint (≥ 4 mEq/L Change from Baseline Serum Bicarbonate or Serum Bicarbonate in the Normal Range \[22 - 29 mEq/L\]): TRC101-Placebo||38.7|10.2|= 0.0015
72377917|NCT03390842|144264377|SUPERIORITY||Treatment difference in % of subjects|24.4|||=|0.0015|TWO_SIDED|95.0|9.7|38.2|||Fisher Exact|||% Subjects with ≥ 4mEq/L Change from Baseline in Serum Bicarbonate: TRC101-Placebo||38.2|9.7|= 0.0015
72377918|NCT03390842|144264377|SUPERIORITY||Treatment difference in % of subjects|30.2|||<|0.0001|TWO_SIDED|95.0|15.6|43.7|||Fisher Exact|||% Subjects with Serum Bicarbonate in Normal Range (22 - 29 mEq/L): TRC101-Placebo||43.7|15.6|< 0.0001
72377919|NCT03390842|144264378|SUPERIORITY||Treatment difference in LS means|1.99|STANDARD_ERROR_OF_MEAN|0.524|=|0.0002|TWO_SIDED|95.0|0.96|3.03|||Mixed-effect repeated measures model||Standard error presented above is for the LS mean.|Least Squares Mean Change from Baseline: TRC101-Placebo||3.03|0.96|= 0.0002
72377920|NCT03390842|144264379|SUPERIORITY||||||<|0.0001||||||p-value based on analysis of covariance model with rank of change from baseline in total score as dependent variable; treatment (PBO or TRC101) as a fixed effect; and baseline total score, Baseline eGFR, Baseline Bicarbonate as continuous covariates.|ANCOVA|||Mean Change from Baseline in KDQOL-PFD: TRC101-Placebo||||< 0.0001
72377921|NCT03390842|144264380|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||Change from Baseline for Repeated Chair Stand Test: TRC101-Placebo||||< 0.0001
72377922|NCT00708201|144264428|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.773|||<|0.0001|TWO_SIDED|95.0|1.359|2.311|||Wald's Chi-Square|||||2.311|1.359|<0.0001
72377923|NCT00708201|144264429|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-24.7|||<|0.001|TWO_SIDED|95.0|-37.8|-11.5|||Log Rank|||||-11.5|-37.8|<0.001
72377924|NCT00708201|144264430|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-22.4|||<|0.001|TWO_SIDED|95.0|-35.0|-9.9|||Log Rank|||||-9.9|-35.0|<0.001
72377925|NCT00708201|144264431|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<0.01
72377926|NCT00708201|144264432|SUPERIORITY_OR_OTHER||Relative Risk|1.38|||<|0.01|TWO_SIDED|95.0|1.12|1.71|||Fisher Exact||This is the relative risk for being a responder (alvimopan/placebo).|||1.71|1.12|<0.01
72377927|NCT00708201|144264433|SUPERIORITY_OR_OTHER||Percent difference|-20.71|||<|0.001|TWO_SIDED||||||Fisher Exact||Percent difference = alvimopan - placebo|Statistical analysis for overall POM is presented.||||<0.001
72377928|NCT00708201|144264434|SUPERIORITY_OR_OTHER||Percent difference|27.05|||<|0.0001|TWO_SIDED||||||Fisher Exact||Percent difference = alvimopan - placebo|Statistical analysis for day of surgery (Day 0) through PSD 7 is presented.||||<0.0001
72377929|NCT00708201|144264435|SUPERIORITY_OR_OTHER||Percent difference|25.2|||<|0.0001|TWO_SIDED||||||Fisher Exact||Percent difference = alvimopan - placebo|Statistical analysis for day of surgery (Day 0) through PSD 7 is presented.||||<0.0001
72377930|NCT00708201|144264436|SUPERIORITY_OR_OTHER||Percent difference|-6.94||||0.0946|TWO_SIDED|95.0|-14.5|0.62|||Fisher Exact||Percent difference = alvimopan - placebo.|||0.62|-14.5|0.0946
72377931|NCT01653132|144264437|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.194|STANDARD_DEVIATION|0.61|||TWO_SIDED|95.0|-0.71|0.32|||||negative values correspond to a reduction in saliva weight with Inco-A.|Based on the primary outcome measure of mean reduction in saliva weight at 1 month post Inco-A /placebo as compared to baseline, using paired t-test with a two-sided nominal significance (alpha) of 0.05, assuming a correlation of 0.5 between observations, a sample size of 10 pairs has a power of 0.803 to detect a 50% difference in salivary weight.||0.32|-0.71|
72377932|NCT01653132|144264438|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-22.3|STANDARD_DEVIATION|0.34|||TWO_SIDED|95.0|-50.8|6.2|||||negative numbers represent reduction in saliva weight with Inco-A|||6.2|-50.8|
72377933|NCT01653132|144264439|SUPERIORITY_OR_OTHER||Median Difference (Net)|-0.33|STANDARD_DEVIATION|1.41|||TWO_SIDED|95.0|-1.16|0.69|||||negative values represent reduction in scores (improvement in drooling) with Inco-A|||0.69|-1.16|
72377934|NCT01653132|144264440|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.333|||||TWO_SIDED|95.0|-0.633|0.071||||||||0.071|-0.633|
72377935|NCT01653132|144264441|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.11|||||TWO_SIDED|95.0|-0.46|0.28||||||||0.28|-0.46|
72433603|NCT00991276|144380369|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-7.87|STANDARD_ERROR_OF_MEAN|0.98|<|0.0001|TWO_SIDED|95.0|-9.81|-5.93||This analysis was step 5 in a step-down procedure (if p-value \< 0.05, then continue to next step) used to control the Type I error rate.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||-5.93|-9.81|<0.0001
72618470|NCT04576949|144767998|SUPERIORITY||Marginal Difference in Proportions|0.16|||<|0.0001|TWO_SIDED|95.0|0.11|0.2||p-value for difference in proportions|Cochran-Mantel-Haenszel|||||0.20|0.11|<.0001
72377936|NCT03828370|144264442|SUPERIORITY|||||||0.04|||||||ANOVA|||||||.04
72377937|NCT03828370|144264443|SUPERIORITY|||||||0.034|||||||Chi-squared|||||||.034
72377938|NCT00461331|144264454|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|96.4|STANDARD_DEVIATION|8.5||0.52||95.0|87.9|100.0|||Regression, Linear|7 patients underwent early termination of either one or both of their test period due to loss of glycemic control||Glucose levels for patients when they were on each insulin were analyzed. All data was analyzed on an intention to treat basis. Repeated measures, paired t-test and Pearson's correlation on SPSS 14.0 for windows and statistical R-package were used to compare the various variables. This was a pilot study.||100.0|87.9|0.52
72377939|NCT00461331|144264455|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|5.35|STANDARD_DEVIATION|4.165||0.15||95.0|0.97|9.23|||Regression, Linear||This was between days 3 and 5 after the last pump infusion line change using Insulin Aspart and Insulin Lispro. Adequate samples were not available to do the analysis for day 2.|All data was analyzed on an intention to treat basis. Repeated measures, paired t-test and Pearson's correlation on SPSS 14.0 for windows and statistical R-package were used to compare the various variables.||9.23|0.97|0.15
72377940|NCT00461331|144264456|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|6.7|STANDARD_DEVIATION|2.35||0.55||95.0|4.4|9.4|||Regression, Linear||This was for test period 1 between days 3 and 5 after the last pump infusion line change.|All data was analyzed on an intention to treat basis. Repeated measures, paired t-test and Pearson's correlation on SPSS 14.0 for windows and statistical R-package were used to compare the various variables.||9.4|4.4|0.55
72618471|NCT04576949|144767999|SUPERIORITY||Odds Ratio (OR)|1.31||||0.3484|TWO_SIDED|95.0|0.75|2.33||Two-sided, calculated by exact computations with clinical site as a stratifier.|exact computations||Stratified by site|Relapse free from Week 6 to Week 24||2.33|0.75|0.3484
72618472|NCT00407030|144768000|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.0|||<|0.001|TWO_SIDED|95.0|-12.0|-5.9||Due to the hierarchical testing no adjustment of type I error was necessary.|ANCOVA|Independent variables in the model were treatment, baseline TWSTRS-Total score, gender, age, pre-treatment of cervical dystonia, and pooled center.||Hierarchical testing: Primary null hypothesis: incobotulinumtoxinA (Xeomin) (240 Units) identical to placebo. Rejection of 1st hypothesis lead to test of 2nd null hypothesis: incobotulinumtoxinA (Xeomin) (120 Units) identical to placebo. Rejection of 2nd hypothesis lead to test of 3rd null hypothesis: incobotulinumtoxinA (Xeomin) (240 Units) identical to incobotulinumtoxinA (Xeomin) (120 Units). 3 separate models were used to test these hypotheses which results in different LS means estimates.||-5.9|-12.0|<0.001
72618473|NCT00407030|144768006|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.5|||<|0.001|TWO_SIDED|95.0|-10.4|-4.6||Due to the hierarchical testing no adjustment of type I error was necessary.|ANCOVA|Independent variables in the model were treatment, baseline TWSTRS-Total score, gender, age, pre-treatment of cervical dystonia, and pooled center.||Hierarchical testing: Primary null hypothesis: incobotulinumtoxinA (Xeomin) (240 Units) identical to placebo. Rejection of 1st hypothesis lead to test of 2nd null hypothesis: incobotulinumtoxinA (Xeomin) (120 Units) identical to placebo. Rejection of 2nd hypothesis lead to test of 3rd null hypothesis: incobotulinumtoxinA (Xeomin) (240 Units) identical to incobotulinumtoxinA (Xeomin) (120 Units). 3 separate models were used to test these hypotheses which results in different LS means estimates.||-4.6|-10.4|<0.001
72618474|NCT00407030|144768007|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.3||||0.447|TWO_SIDED|95.0|-2.1|4.6||Due to the hierarchical testing no adjustment of type I error was necessary.|ANCOVA|Independent variables in the model were treatment, baseline TWSTRS-Total score, gender, age, pre-treatment of cervical dystonia, and pooled center.||Hierarchical testing: Primary null hypothesis: incobotulinumtoxinA (Xeomin) (240 Units) identical to placebo. Rejection of 1st hypothesis lead to test of 2nd null hypothesis: incobotulinumtoxinA (Xeomin) (120 Units) identical to placebo. Rejection of 2nd hypothesis lead to test of 3rd null hypothesis: incobotulinumtoxinA (Xeomin) (240 Units) identical to incobotulinumtoxinA (Xeomin) (120 Units). 3 separate models were used to test these hypotheses which results in different LS means estimates.||4.6|-2.1|0.447
72618475|NCT03193307|144768008|OTHER||Geometric Mean (T1/R1) ratio (%)|153.2|||||TWO_SIDED|90.0|134.34|174.7|||||"Analysis of variance (ANOVA) model including random effect for 'subject' and fixed effect for 'treatment' was used.~Intra-individual geometric coefficient of variation (gCV \[%\]) =21.4."|||174.70|134.34|
72618476|NCT03193307|144768009|OTHER||Geometric Mean (T1/R1) ratio (%)|115.91|||||TWO_SIDED|90.0|104.559|128.502|||||"Analysis of variance (ANOVA) including random effect for 'subject' and fixed effect for 'treatment' was used.~Intra-individual geometric coefficient of variation (gCV \[%\]) = 16.7."|||128.502|104.559|
72618477|NCT03193307|144768010|OTHER||Geometric Mean (T2/R2) ratio (%)|104.82|||||TWO_SIDED|90.0|102.092|107.613|||||"Analysis of variance (ANOVA) model including random effect for 'subject' and fixed effect for 'treatment' was used.~Intra-individual geometric coefficient of variation (gCV \[%\]) =4.3."|||107.613|102.092|
72618478|NCT03193307|144768011|OTHER||Geometric Mean (T2/R2) ratio (%)|102.77|||||TWO_SIDED|90.0|100.66|104.92|||||"Analysis of variance (ANOVA) model including random effect for 'subject' and fixed effect for 'treatment' was used.~Intra-individual geometric coefficient of variation (gCV \[%\]) = 3.3."|||104.92|100.66|
72618479|NCT03193307|144768012|OTHER||Geometric Mean (T2/R2) ratio (%)|114.12|||||TWO_SIDED|90.0|109.266|119.183|||||"Analysis of variance (ANOVA) model including random effect for 'subject' and fixed effect for 'treatment' was used.~Intra-individual geometric coefficient of variation (gCV \[%\])=7.0."|||119.183|109.266|
72618480|NCT03193307|144768013|OTHER||Geometric Mean (T2/R2) ratio (%)|110.7|||||TWO_SIDED|90.0|105.8|115.83|||||"Analysis of variance (ANOVA) model including random effect for 'subject' and fixed effect for 'treatment' was used.~Intra-individual geometric coefficient of variation (gCV \[%\]) = 7.3."|||115.83|105.80|
72618481|NCT03193307|144768014|OTHER||Geometric Mean (T1/R1) ratio (%)|154.15|||||TWO_SIDED|90.0|133.81|177.58|||||"Analysis of variance (ANOVA) model including random effect for 'subject' and fixed effect for 'treatment' was used.~Intra-individual geometric coefficient of variation (gCV \[%\]) = 22.4."|||177.58|133.81|
72618482|NCT00567112|144768035|NON_INFERIORITY_OR_EQUIVALENCE|Geometric Mean Ratio of OCT (fasted)/DFC (fasted)|Geometric Mean Ratio|0.98|||>|0.2|TWO_SIDED|90.0|0.92|1.05|||ANOVA|||OCT (fasted)/DFC (fasted)||1.05|0.92|>0.200
72618483|NCT00567112|144768036|NON_INFERIORITY_OR_EQUIVALENCE|Geometric Mean Ratio of OCT (fasted)/DFC (fasted)|Geometric Mean Ratio|0.98|||>|0.2|TWO_SIDED|90.0|0.8|1.19|||ANOVA|||OCT (fasted)/DFC (fasted)||1.19|0.80|>0.200
72618484|NCT00567112|144768037|NON_INFERIORITY_OR_EQUIVALENCE|Geometric Mean Ratio of OCT (after meal)/OCT (fasted)|Geometric Mean Ratio|0.92||||0.026|TWO_SIDED|90.0|0.86|0.98|||ANOVA|||OCT (after meal)/OCT (fasted)||0.98|0.86|0.026
72618485|NCT00567112|144768038|NON_INFERIORITY_OR_EQUIVALENCE|Geometric Mean Ratio OCT (after meal)/OCT (fasted)|Geometric Mean Ratio|0.59|||<|0.001|TWO_SIDED|90.0|0.49|0.72|||ANOVA|||OCT (after meal)/OCT (fasted)||0.72|0.49|<0.001
72618486|NCT00567112|144768039|SUPERIORITY_OR_OTHER||||||>|0.2||95.0|||||ANOVA|||OCT (fasted)/DFC (fasted)||||>0.200
72377941|NCT03312751|144264457|SUPERIORITY||Overall response rate|62.9||||0.0053|TWO_SIDED|95.0|44.9|78.5|||Exact binomial|||The primary efficacy endpoint was analyzed with an exact binomial test to evaluate the null hypothesis that the Overall Response Rate was, at most, 40%. This test was performed at the one sided 0.025 significance level.||78.5|44.9|0.0053
72377942|NCT03312751|144264457|SUPERIORITY|||||||0.2839|||||||Exact binomial|||The primary efficacy endpoint was analyzed with an exact binomial test to evaluate the null hypothesis that the Overall Response Rate was, at most, 40%. This test was performed at the one sided 0.025 significance level.||||0.2839
72618487|NCT00567112|144768040|SUPERIORITY_OR_OTHER||||||>|0.2||95.0|||||ANOVA|||OCT (fasted)/DFC (fasted)||||>0.200
72377943|NCT03312751|144264457|SUPERIORITY|||||||0.0031|||||||Exact binomial|||The primary efficacy endpoint was analyzed with an exact binomial test to evaluate the null hypothesis that the Overall Response Rate was, at most, 40%. This test was performed at the one sided 0.025 significance level.||||0.0031
72377944|NCT03490981|144264475|SUPERIORITY||Mean Difference (Final Values)|0.33|STANDARD_ERROR_OF_MEAN|0.47||0.486|TWO_SIDED||||||ANCOVA|||||||.486
72377945|NCT03490981|144264476|SUPERIORITY||Mean Difference (Final Values)|1.12|STANDARD_ERROR_OF_MEAN|1.16||0.342|TWO_SIDED||||||ANCOVA|||||||.342
72377946|NCT03490981|144264477|SUPERIORITY||Mean Difference (Final Values)|-0.61|STANDARD_ERROR_OF_MEAN|1.31||0.646|TWO_SIDED||||||ANCOVA|||||||.646
72377947|NCT03490981|144264478|SUPERIORITY||Mean Difference (Final Values)|1.13|STANDARD_ERROR_OF_MEAN|0.205||0.205|TWO_SIDED||||||ANCOVA|||||||.205
72377948|NCT03490981|144264479|SUPERIORITY||Mean Difference (Final Values)|-2.05|STANDARD_ERROR_OF_MEAN|2.94||0.492|TWO_SIDED||||||ANCOVA|||||||.492
72377949|NCT03490981|144264480|SUPERIORITY||Mean Difference (Final Values)|4.31|STANDARD_ERROR_OF_MEAN|3.84||0.272|TWO_SIDED||||||ANCOVA|||||||.272
72377950|NCT03490981|144264481|SUPERIORITY||Mean Difference (Final Values)|-0.8|STANDARD_ERROR_OF_MEAN|4.82||0.87|TWO_SIDED||||||ANCOVA|||||||.870
72377951|NCT03490981|144264482|SUPERIORITY||Mean Difference (Final Values)|0.96|STANDARD_ERROR_OF_MEAN|1.67||0.57|TWO_SIDED||||||ANCOVA|||||||.570
72377952|NCT00282464|144264493|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0056||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 1||||0.0056
72377953|NCT00282464|144264493|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0866||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 2||||0.0866
72377954|NCT00282464|144264493|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0568||||||For all secondary efficacy analyses, no multiple comparison adjustment were made.|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 3||||0.0568
72377955|NCT00282464|144264493|SUPERIORITY_OR_OTHER_LEGACY|||||||0.013||||||For all secondary efficacy analyses, no multiple comparison adjustment were made.|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 4||||0.0130
72377956|NCT00282464|144264493|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0188||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 5||||0.0188
72377957|NCT00282464|144264493|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6394||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 6||||0.6394
72377958|NCT00282464|144264493|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7707||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Endpoint||||0.7707
72377959|NCT00282464|144264494|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2185||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 3||||0.2185
72377960|NCT00282464|144264494|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4124||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 6||||0.4124
72377961|NCT00282464|144264494|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6098||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Endpoint||||0.6098
72377962|NCT00282464|144264495|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0005||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 1||||0.0005
72377963|NCT00282464|144264495|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0099||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 2||||0.0099
72377964|NCT00282464|144264495|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0423||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 3||||0.0423
72377965|NCT00282464|144264495|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0618||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 4||||0.0618
72377966|NCT00282464|144264495|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0451||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 5||||0.0451
72377967|NCT00282464|144264495|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2633||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 6||||0.2633
72377968|NCT00282464|144264495|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2206||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Endpoint||||0.2206
72377969|NCT00282464|144264496|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9863||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 3||||0.9863
72618488|NCT00567112|144768041|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA|||OCT (after meal)/OCT (fasted)||||<0.001
72618489|NCT00567112|144768042|SUPERIORITY_OR_OTHER||||||>|0.2|||||||ANOVA|||OCT (after meal)/OCT (fasted)||||>0.200
72377970|NCT00282464|144264496|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1017||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 6||||0.1017
72377971|NCT00282464|144264496|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4033||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Endpoint||||0.4033
72377972|NCT00282464|144264497|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002||||||No multiple comparison adjustment is applicable. Statistical significance level was 0.05|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 1||||0.002
72377973|NCT00282464|144264497|SUPERIORITY_OR_OTHER_LEGACY|||||||0.019|||||||Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 2||||0.019
72377974|NCT00282464|144264497|SUPERIORITY_OR_OTHER_LEGACY|||||||0.038|||||||Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 3||||0.038
72377975|NCT00282464|144264497|SUPERIORITY_OR_OTHER_LEGACY|||||||0.069|||||||Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 4||||0.069
72377976|NCT00282464|144264497|SUPERIORITY_OR_OTHER_LEGACY|||||||0.053|||||||Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 5||||0.053
72377977|NCT00282464|144264497|SUPERIORITY_OR_OTHER_LEGACY|||||||0.154|||||||Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 6 An estimated sample size of 180 was needed per treatment arm in order to achieve 85% power to detect a treatment difference of 3.5 in the mean change from baseline to Week 6 in MADRS total score with a two-sided t-test at the 0.05 significance level. The common standard deviation was estimated as 11.0. The null hypotheses is equality of mean change from baseline to Week 6 in MADRS total score between ziprasidone and placebo groups.||||0.154
72377978|NCT00282464|144264497|SUPERIORITY_OR_OTHER_LEGACY|||||||0.007|||||||Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Overall||||0.007
72377979|NCT00282464|144264498|SUPERIORITY_OR_OTHER_LEGACY|||||||0.112||||||For all efficacy analyses, no multiple comparisons adjustments were made|ANCOVA|ANCOVA model included effects of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate.||Week 3||||0.112
72377980|NCT00282464|144264498|SUPERIORITY_OR_OTHER_LEGACY|||||||0.352||||||For all efficacy analyses, no multiple comparisons adjustments were made|ANCOVA|ANCOVA model included effects of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Week 6||||0.352
72618490|NCT04913675|144768060|NON_INFERIORITY|This outcome measure was analyzed using a hypothetical estimand and assessing non-inferiority of 500 mg IM dose versus 500 mg IV using a non-inferiority margin of 3.5 percent (%) on the risk difference scale. A post-hoc weekly imputation algorithm imputes the missing outcome iteratively for each week, where missing outcomes at Day 8, 15, 22, 29 are imputed.|Risk Difference (RD)|1.06|||||TWO_SIDED|95.0|-1.15|3.26|||||Analysis was performed using a binomial regression model with identity link function and with treatment (Sotrovimab 500mg IM, 500mg IV), age (\<65, =\>65 years old) and gender (male, female) as covariates.|||3.26|-1.15|
72377981|NCT00282464|144264498|SUPERIORITY_OR_OTHER_LEGACY|||||||0.873||||||For all efficacy analyses, no multiple comparisons adjustments were made|ANCOVA|ANCOVA model included effects of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate.||Endpoint||||0.873
72377982|NCT00282464|144264499|SUPERIORITY_OR_OTHER_LEGACY|||||||0.305||||||For all efficacy analyses, no multiple comparisons adjustments were made|ANCOVA|ANCOVA model included effects of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate.||Week 3||||0.305
72377983|NCT00282464|144264499|SUPERIORITY_OR_OTHER_LEGACY|||||||0.51||||||For all efficacy analyses, no multiple comparisons adjustments were made.|ANCOVA|ANCOVA model included effects of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate.||Week 6||||0.510
72377984|NCT00282464|144264499|SUPERIORITY_OR_OTHER_LEGACY|||||||0.71||||||For all efficacy analyses, no multiple comparisons adjustments were made|ANCOVA|ANCOVA model included effects of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate.||Endpoint||||0.710
72377985|NCT00282464|144264500|SUPERIORITY_OR_OTHER_LEGACY|||||||0.026||||||For all efficacy analyses, no multiple comparisons adjustments were made|ANCOVA|ANCOVA model included effects of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate.||Week 3||||0.026
72377986|NCT00282464|144264500|SUPERIORITY_OR_OTHER_LEGACY|||||||0.223||||||For all efficacy analyses, no multiple comparisons adjustments were made|ANCOVA|ANCOVA model included effects of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate.||Week 6||||0.223
72377987|NCT00282464|144264500|SUPERIORITY_OR_OTHER_LEGACY|||||||0.848||||||For all efficacy analyses, no multiple comparisons adjustments were made|ANCOVA|ANCOVA model included effects of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate.||Endpoint||||0.848
72377988|NCT00282464|144264501|SUPERIORITY_OR_OTHER_LEGACY|||||||0.381||||||For all efficacy analyses, no multiple comparisons adjustments were made|ANCOVA|ANCOVA model included effects of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate.||Week 3||||0.381
72377989|NCT00282464|144264501|SUPERIORITY_OR_OTHER_LEGACY|||||||0.676||||||For all efficacy analyses, no multiple comparisons adjustments were made|ANCOVA|ANCOVA model included effects of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate.||Week 6||||0.676
72377990|NCT00282464|144264501|SUPERIORITY_OR_OTHER_LEGACY|||||||0.295||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|ANCOVA model included effects of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate.||Endpoint||||0.295
72377991|NCT00282464|144264502|SUPERIORITY_OR_OTHER_LEGACY|||||||0.068||||||For all efficacy analyses, no multiple comparisons adjustments were made|ANCOVA|ANCOVA model included effects of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate.||Week 3||||0.068
72377992|NCT00282464|144264502|SUPERIORITY_OR_OTHER_LEGACY|||||||0.043||||||For all efficacy analyses, no multiple comparisons adjustments were made|ANCOVA|ANCOVA model included effects of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate.||Week 6||||0.043
72377993|NCT00282464|144264502|SUPERIORITY_OR_OTHER_LEGACY|||||||0.404||||||For all efficacy analyses, no multiple comparisons adjustments were made|ANCOVA|ANCOVA model included effects of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate.||Endpoint||||0.404
72377994|NCT00282464|144264503|SUPERIORITY_OR_OTHER_LEGACY|||||||0.899||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|ANCOVA model included effects of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Week 3||||0.899
72377995|NCT00282464|144264503|SUPERIORITY_OR_OTHER_LEGACY|||||||0.739||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|ANCOVA model included effects of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Week 6||||0.739
72377996|NCT00282464|144264503|SUPERIORITY_OR_OTHER_LEGACY|||||||0.797||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|ANCOVA model included effects of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate.||Endpoint||||0.797
72377997|NCT00282464|144264504|SUPERIORITY_OR_OTHER_LEGACY|||||||0.434||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|ANCOVA model included effects of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate.||Week 3||||0.434
72377998|NCT00282464|144264504|SUPERIORITY_OR_OTHER_LEGACY|||||||0.777||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|ANCOVA model included effects of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate.||Week 6||||0.777
72377999|NCT00282464|144264504|SUPERIORITY_OR_OTHER_LEGACY|||||||0.82||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|ANCOVA model included effects of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate.||Endpoint||||0.820
72378000|NCT00282464|144264505|SUPERIORITY_OR_OTHER_LEGACY|||||||0.468||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 1||||0.468
72378001|NCT00282464|144264505|SUPERIORITY_OR_OTHER_LEGACY|||||||0.11||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 2||||0.110
72378002|NCT00282464|144264505|SUPERIORITY_OR_OTHER_LEGACY|||||||0.738||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 3||||0.738
72378003|NCT00282464|144264505|SUPERIORITY_OR_OTHER_LEGACY|||||||0.617||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 4||||0.617
72378004|NCT00282464|144264505|SUPERIORITY_OR_OTHER_LEGACY|||||||0.642||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 5||||0.642
72378005|NCT00282464|144264505|SUPERIORITY_OR_OTHER_LEGACY|||||||0.644||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 6||||0.644
72378006|NCT00282464|144264505|SUPERIORITY_OR_OTHER_LEGACY|||||||0.789||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Overall||||0.789
72378007|NCT00282464|144264506|SUPERIORITY_OR_OTHER_LEGACY|||||||0.042||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 1||||0.042
72378008|NCT00282464|144264506|SUPERIORITY_OR_OTHER_LEGACY|||||||0.088||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 2||||0.088
72378009|NCT00282464|144264506|SUPERIORITY_OR_OTHER_LEGACY|||||||0.651||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 3||||0.651
72378010|NCT00282464|144264506|SUPERIORITY_OR_OTHER_LEGACY|||||||0.665||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 4||||0.665
72433604|NCT00991276|144380369|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|5.2|STANDARD_ERROR_OF_MEAN|0.97|<|0.0001|TWO_SIDED|95.0|3.27|7.12||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||7.12|3.27|<0.0001
72378011|NCT00282464|144264506|SUPERIORITY_OR_OTHER_LEGACY|||||||0.349||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 5||||0.349
72378012|NCT00282464|144264506|SUPERIORITY_OR_OTHER_LEGACY|||||||0.685||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 6||||0.685
72378013|NCT00282464|144264506|SUPERIORITY_OR_OTHER_LEGACY|||||||0.257||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Overall||||0.257
72378014|NCT00282464|144264507|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0099||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical effect: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction.||Week 1||||0.0099
72378015|NCT00282464|144264507|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0654||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical effect: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction.||Week 2||||0.0654
72378016|NCT00282464|144264507|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1807||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical effect: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction.||Week 3||||0.1807
72378017|NCT00282464|144264507|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0957||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical effect: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction.||Week 4||||0.0957
72378018|NCT00282464|144264507|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0752||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical effect: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction.||Week 5||||0.0752
72378019|NCT00282464|144264507|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3964||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical effect: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction.||Week 6||||0.3964
72378020|NCT00282464|144264507|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0287||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical effect: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction.||Overall||||0.0287
72378021|NCT00282464|144264508|SUPERIORITY_OR_OTHER_LEGACY|||||||0.965||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|ANCOVA model included effects of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate.||Change from baseline to endpoint||||0.965
72378022|NCT00282464|144264509|SUPERIORITY_OR_OTHER_LEGACY|||||||0.86||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|ANCOVA model included effects of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate.||Change from baseline to endpoint||||0.860
72378023|NCT00282464|144264510|SUPERIORITY_OR_OTHER_LEGACY|||||||0.428||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|ANCOVA model included effects of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate.||Baseline to endpoint||||0.428
72378024|NCT00282464|144264511|SUPERIORITY_OR_OTHER_LEGACY|||||||0.708||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANOVA|ANOVA model included effects of treatment, rapid cycling, center and prior hospitalization status||Change from baseline to endpoint||||0.708
72378025|NCT00282464|144264512|SUPERIORITY_OR_OTHER_LEGACY|||||||0.898||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANOVA|ANCOVA model included effects of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate.||Endpoint||||0.898
72378026|NCT00282464|144264513|SUPERIORITY_OR_OTHER_LEGACY|||||||0.559||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANOVA|ANOVA model included effects of treatment, rapid cycling, center and prior hospitalization status.||Endpoint||||0.559
72378027|NCT00282464|144264514|SUPERIORITY_OR_OTHER_LEGACY|||||||0.458||||||For all secondary efficacy analyses, no multiple adjustments were made|ANOVA|ANVOVA model included effects of treatment, rapid cycling, center and prior hospitalization status.||Endpoint||||0.458
72378028|NCT00046891|144264533|SUPERIORITY_OR_OTHER|||||||0.84|TWO_SIDED||||||t-test, 2 sided|||Total HSCS Area Under the Curve (AUC) scores between the two treatment arms.||||0.84
72378029|NCT04391569|144264568|OTHER|||||||0||||||P-value from logistic regression is used for interim data, and Boschloo's test p-value is used for post interim data.|fixed weight combination test|P-value is derived by fixed weight (2/3 for interim and 1/3 for post interim) combination test.||||||0.0000
72378030|NCT04391569|144264569|OTHER|||||||0.1619||||||P-value from logistics regression is used for interim data, and Boschloo's test p-value is used for post interim data.|fixed weight combination test|P-value is derive by fixed weight (2/3 for interim and 1/3 for post interim) combination test.||||||0.1619
72378031|NCT04391569|144264571|OTHER|||||||0.2097|||||||fixed weight combination test|||||||0.2097
72378032|NCT04391569|144264572|OTHER|||||||0|||||||Log Rank|||||||0.0000
72378033|NCT04391569|144264573|OTHER|||||||0.0075||||||P-value is derived by fixed weight (2/3 for interim and 1/3 for post interim) combination test. P-value from logistics regression is used for interim data, and Boschloo's test p-value is used for post interim data.|fixed weight combination test|||||||0.0075
72378034|NCT04445792|144264598|SUPERIORITY|||||||0.7195|||||||Wilcoxon (Mann-Whitney)|||||||0.7195
72378035|NCT04445792|144264598|SUPERIORITY|||||||0.8054|||||||Wilcoxon (Mann-Whitney)|||||||0.8054
72378036|NCT04445792|144264598|SUPERIORITY|||||||0.861|||||||Wilcoxon (Mann-Whitney)|||||||0.861
72378037|NCT04445792|144264599|SUPERIORITY|||||||0.4385|||||||Wilcoxon (Mann-Whitney)|||||||0.4385
72378038|NCT04445792|144264599|SUPERIORITY|||||||0.7185|||||||Wilcoxon (Mann-Whitney)|||||||0.7185
72378039|NCT04445792|144264599|SUPERIORITY|||||||0.431|||||||Wilcoxon (Mann-Whitney)|||||||0.431
72378040|NCT04445792|144264600|SUPERIORITY|||||||0.9222|||||||Wilcoxon (Mann-Whitney)|||||||0.9222
72378041|NCT04445792|144264600|SUPERIORITY|||||||0.1918|||||||Wilcoxon (Mann-Whitney)|||||||0.1918
72378042|NCT04445792|144264600|SUPERIORITY|||||||0.0119|||||||Wilcoxon (Mann-Whitney)|||||||0.0119
72378043|NCT04445792|144264601|SUPERIORITY|||||||0.6971|||||||Wilcoxon (Mann-Whitney)|||||||0.6971
72378044|NCT04445792|144264601|SUPERIORITY|||||||0.2309|||||||Wilcoxon (Mann-Whitney)|||||||0.2309
72378045|NCT04445792|144264601|SUPERIORITY|||||||0.0441|||||||Wilcoxon (Mann-Whitney)|||||||0.0441
72378046|NCT04445792|144264602|SUPERIORITY|||||||0.7988|||||||Wilcoxon (Mann-Whitney)|||||||0.7988
72378047|NCT04445792|144264602|SUPERIORITY|||||||0.0483|||||||Wilcoxon (Mann-Whitney)|||||||0.0483
72378048|NCT04445792|144264602|SUPERIORITY|||||||0.0104|||||||Wilcoxon (Mann-Whitney)|||||||0.0104
72378049|NCT04445792|144264603|SUPERIORITY|||||||0.521|||||||Wilcoxon (Mann-Whitney)|||||||0.521
72378050|NCT04445792|144264603|SUPERIORITY|||||||0.2348|||||||Wilcoxon (Mann-Whitney)|||||||0.2348
72378051|NCT04445792|144264603|SUPERIORITY|||||||0.0517|||||||Wilcoxon (Mann-Whitney)|||||||0.0517
72378052|NCT04445792|144264604|SUPERIORITY|||||||0.6835|||||||Wilcoxon (Mann-Whitney)|||||||0.6835
72378053|NCT04445792|144264604|SUPERIORITY|||||||0.0205|||||||Wilcoxon (Mann-Whitney)|||||||0.0205
72378054|NCT04445792|144264604|SUPERIORITY|||||||0.0036|||||||Wilcoxon (Mann-Whitney)|||||||0.0036
72378055|NCT04445792|144264605|SUPERIORITY|||||||0.5878|||||||Wilcoxon (Mann-Whitney)|||||||0.5878
72378056|NCT04445792|144264605|SUPERIORITY|||||||0.1051|||||||Wilcoxon (Mann-Whitney)|||||||0.1051
72378057|NCT04445792|144264605|SUPERIORITY|||||||0.0292|||||||Wilcoxon (Mann-Whitney)|||||||0.0292
72378058|NCT04445792|144264606|SUPERIORITY||||||<|0.0001|||||||Chi-squared|||||||<0.0001
72378059|NCT04445792|144264606|SUPERIORITY|||||||0.5973|||||||Chi-squared|||||||0.5973
72378060|NCT04445792|144264606|SUPERIORITY|||||||0.0046|||||||Chi-squared|||||||0.0046
72378061|NCT02320903|144264618|EQUIVALENCE|What was the within-group change over time effect size (Cohen's d)?|||||||||||||Paired samples T test (change over time)|||Paired sample T tests were used to measure change for parents over time.|Cohen's d for parent report on this measure was 0.16.|||
72378062|NCT02320903|144264618|EQUIVALENCE|What was the within-group change over time effect size (Cohen's d)?|||||||||||||Paired samples T test (change over time)|||Paired sample T tests were used to measure change over time for teens.|Cohen's d for youth report was d = 0.22.|||
72378063|NCT02320903|144264619|EQUIVALENCE|What was the within-group change over time effect size (Cohen's d)?|||||||||||||Paired samples T test (change over time)|||Paired sample T tests were used to measure change for parents over time.|Cohen's d for parent report on this measure was d = 0.22.|||
72378064|NCT02320903|144264619|OTHER|What was the within-group change over time effect size?||||||||||||||||Paired sample T tests were used to measure change for teens over time.|Cohen's d for teen report on this measure was d = 0.22.|||
72378065|NCT02320903|144264620|EQUIVALENCE|What was the within-group change over time effect size (Cohen's d)?|||||||||||||Paired samples T test (change over time)|||Paired sample T tests were used to measure change for parents over time.|Cohen's d for parent report on this measure was d = 0.10.|||
72378066|NCT02320903|144264620|EQUIVALENCE|What was the within-group change over time effect size? (Cohen's d)||||||||||||||||Paired samples T tests were used to measure change over time for teens.|Cohen's d for youth report was d = 0.28.|||
72378067|NCT02320903|144264621|EQUIVALENCE|What was the within-group change over time effect size (Cohen's d)?|||||||||||||Paired samples T test (change over time)|||Paired sample T tests were used to measure change for parents over time.|Cohen's d for parent report on this measure was d = 0.16.|||
72378068|NCT02320903|144264621|EQUIVALENCE|What was the within-group change over time effect size? (Cohen's d)||||||||||||||||Paired sample T tests were used to measure change for teens over time.|Cohen's d for youth report was d = 0.21.|||
72378069|NCT02320903|144264622|EQUIVALENCE|What was the within-group change over time effect size (Cohen's d)?|||||||||||||Paired samples T test (change over time)|||Paired sample T tests were used to measure change for parents over time.|Cohen's d for parent report on this measure was d = 0.62.|||
72378070|NCT02320903|144264622|EQUIVALENCE|What was the within-group change over time effect size (Cohen's d)?||||||||||||||||Paired sample T tests were used to measure change over time for teens.|Cohen's d for youth report was d = 0.23.|||
72378071|NCT02320903|144264623|EQUIVALENCE|What was the within-group change over time effect size (Cohen's d)?||||||||||||||||Paired sample T tests were used to measure change for parents over time.|Cohen's d for parent report on this measure was d = 0.22.|||
72378072|NCT02320903|144264623|EQUIVALENCE|What was the within-group change over time effect size (Cohen's d)?||||||||||||||||Paired samples T tests were used to measure within-groups change over time for teens.|Cohen's d for youth report was d = 0.26.|||
72378073|NCT02320903|144264624|EQUIVALENCE|What was the within-group change over time effect size (Cohen's d)?||||||||||||||||Paired sample T tests were used to measure change for parents over time.|Cohen's d for parent report on this measure was d =.12.|||
72378074|NCT02320903|144264625|EQUIVALENCE|What was the within-group change over time effect size (Cohen's d)?||||||||||||||||Paired sample T tests were used to measure change for parents over time.|Cohen's d for parent report on this measure was d = 0.81.|||
72378075|NCT02320903|144264626|EQUIVALENCE|What was the within-group change over time effect size (Cohen's d)?||||||||||||||||Paired sample T tests were used to measure change for parents over time.|Cohen's d for parent report on this measure was d = 0.43.|||
72378076|NCT02320903|144264627|EQUIVALENCE|What was the within-group change over time effect size (Cohen's d)?||||||||||||||||Paired sample T tests were used to measure change for teens over time.|Cohen's d for youth report on this measure was d = 24.|||
72378077|NCT03493815|144264628|SUPERIORITY||Risk Ratio (RR)|0.73||||0.51|TWO_SIDED|95.0|0.28|1.9|||binary regression w/ comp log-log link||Ultrasound guided is the numerator and traditional is the denominator.|||1.90|0.28|0.51
72378078|NCT03493815|144264629|SUPERIORITY||Risk Ratio (RR)|0.58||||0.41|TWO_SIDED|95.0|0.15|2.18|||binary regression w/ comp log-log link||Ultrasound guided is the numerator and traditional is the denominator.|||2.18|0.15|0.41
72378079|NCT03493815|144264630|SUPERIORITY|||||||0.76|||||||t-test, 2 sided|||||||0.76
72378080|NCT03493815|144264631|SUPERIORITY|||||||0.7|||||||Fisher Exact|||||||0.70
72378081|NCT01099709|144264632|NON_INFERIORITY_OR_EQUIVALENCE|A mixed-model analysis of variance was used to compare (test vs reference) and the 90% confidence intervals were estimated for the ratios (test/reference).|Geometric Test/Ref Ratio x 100|105.0|||||TWO_SIDED|90.0|101.06|108.51|||||Bioequivalence was established when 90% Confidence Interval fell within 80%-125%.|||108.51|101.06|
72378082|NCT01099709|144264632|NON_INFERIORITY_OR_EQUIVALENCE|A mixed-model analysis of variance was used to compare (test vs reference) and the 90% confidence intervals were estimated for the ratios (test/reference)|Geometric Test/Ref Ratio x 100|105.0|||||TWO_SIDED|90.0|101.06|108.51|||ANOVA||Bioequivalence is established when 90% Confidence Interval falls within 80%-125%.|||108.51|101.06|
72378083|NCT01099709|144264633|NON_INFERIORITY_OR_EQUIVALENCE|A mixed-model analysis of variance was used to compare (test vs reference) and the 90% confidence intervals were estimated for the ratios (test/reference)|Geometric Test/Ref Ratio x 100|95.6|||||TWO_SIDED|90.0|93.73|97.53|||ANOVA||Bioequivalence is established when 90% Confidence Interval falls within 80%-125%.|||97.53|93.73|
72378084|NCT01099709|144264634|NON_INFERIORITY_OR_EQUIVALENCE|A mixed-model analysis of variance was used to compare (test vs reference) and the 90% confidence intervals were estimated for the ratios (test/reference)|Geometric test/Ref Ratio x 100|95.7|||||TWO_SIDED|90.0|93.85|97.68|||ANOVA||Bioequivalence is established when 90% Confidence Interval falls within 80%-125%.|||97.68|93.85|
72378085|NCT01122394|144264645|SUPERIORITY_OR_OTHER|||||||0.29|||||||robust regression|controlling for provider clustering||Robust regressions were performed||||0.29
72378086|NCT01122394|144264646|SUPERIORITY_OR_OTHER|||||||0.25|||||||Regression, Logistic|This analysis includes participants in pre-action and action/maintenance||||||0.25
72378087|NCT01122394|144264647|SUPERIORITY_OR_OTHER|||||||0.11|||||||Wilcoxon (Mann-Whitney)|||||||0.11
72378088|NCT01122394|144264648|SUPERIORITY_OR_OTHER|||||||0.81|||||||Regression, Linear|||||||0.81
72378089|NCT01122394|144264649|SUPERIORITY_OR_OTHER|||||||0.12|||||||Regression, Linear|||||||0.12
72378090|NCT00039871|144264650|SUPERIORITY_OR_OTHER||Binomial Approximation|0.217||||||99.0|0.195|0.239||||||||0.239|0.195|
72378091|NCT00039871|144264651|SUPERIORITY_OR_OTHER||Binomial Approximation|0.563||||||95.0|0.529|0.596||||||||0.596|0.529|
72378092|NCT00039871|144264652|SUPERIORITY_OR_OTHER||Binomial Approximation|0.122||||||95.0|0.076|0.169||||||||0.169|0.076|
72378093|NCT01555957|144264654|SUPERIORITY|||||||0.94|||||||Chi-squared|||we hypothesized that among ≥ 34 weeks GA infants with GISDs, infants receiving 1g/kg/day S-ILE (lipid minimizing strategy) would have decreased incidence of IFALD compared to those receiving 2g/kg/day S-ILE. We also hypothesized that the rate of rise of DB would be lower among ≥ 34 weeks GA infants with GISDs receiving 1g/kg/day versus 2g/kg/day of S-ILE.||||0.94
72378094|NCT01555957|144264655|SUPERIORITY|||||||0.0005|||||||Mixed Models Analysis|||We also hypothesized that the rate of rise of direct bilirubin would be lower among ≥ 34 weeks GA infants with GISDs receiving 1g/kg/day versus 2g/kg/day of S-ILE.||||0.0005
72378095|NCT00718081|144264656|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|19.48|STANDARD_ERROR_OF_MEAN|4.92|<|0.001|ONE_SIDED|95.0|||||ANCOVA|||||||<0.001
72378096|NCT00718081|144264656|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|24.62|STANDARD_ERROR_OF_MEAN|4.86|<|0.001|ONE_SIDED|95.0|||||ANCOVA|||||||<0.001
72378097|NCT01931670|144264685|SUPERIORITY||||||<|0.001||||||An elagolix dose group was to be considered more efficacious than placebo for the co-primary endpoints if and only if both co-primary endpoints (DYS and NMPP) were statistically significant for the elagolix dose group at the 0.025 significance level.|Regression, Logistic|||||||< 0.001
72378098|NCT01931670|144264685|SUPERIORITY||||||<|0.001||||||An elagolix dose group was to be considered more efficacious than placebo for the co-primary endpoints if and only if both co-primary endpoints (DYS and NMPP) were statistically significant for the elagolix dose group at the 0.025 significance level.|Regression, Logistic|||||||< 0.001
72378099|NCT01931670|144264686|SUPERIORITY|||||||0.003||||||An elagolix dose group was to be considered more efficacious than placebo for the co-primary endpoints if and only if both co-primary endpoints (DYS and NMPP) were statistically significant for the elagolix dose group at the 0.025 significance level.|Regression, Logistic|||||||0.003
72378100|NCT01931670|144264686|SUPERIORITY||||||<|0.001||||||An elagolix dose group was to be considered more efficacious than placebo for the co-primary endpoints if and only if both co-primary endpoints (DYS and NMPP) were statistically significant for the elagolix dose group at the 0.025 significance level.|Regression, Logistic|||||||< 0.001
72378101|NCT01931670|144264687|SUPERIORITY||Difference in LS Mean Change|-0.57|STANDARD_ERROR_OF_MEAN|0.156|<|0.001|TWO_SIDED|||||For an elagolix dose group to be considered statistically significantly better than placebo on a secondary endpoint, the P value must have been ≤ 0.025 for that endpoint, for all higher-ranking secondary endpoints, and for the co-primary endpoints.|mixed-effects model|||Ranked secondary efficacy endpoint 1 of 7.||||<0.001
72378102|NCT01931670|144264687|SUPERIORITY||Difference in LS Mean Change|-1.22|STANDARD_ERROR_OF_MEAN|0.156|<|0.001|TWO_SIDED|||||For an elagolix dose group to be considered statistically significantly better than placebo on a secondary endpoint, the P value must have been ≤ 0.025 for that endpoint, for all higher-ranking secondary endpoints, and for the co-primary endpoints.|mixed-effects model|||Ranked secondary efficacy endpoint 1 of 7.||||< 0.001
72378103|NCT01931670|144264688|SUPERIORITY||Difference in LS Mean Change|-0.54|STANDARD_ERROR_OF_MEAN|0.074|<|0.001|TWO_SIDED|||||For an elagolix dose group to be considered statistically significantly better than placebo on a secondary endpoint, the P value must have been ≤ 0.025 for that endpoint, for all higher-ranking secondary endpoints, and for the co-primary endpoints.|mixed-effects model|||Ranked secondary efficacy endpoint 2 of 7.||||< 0.001
72433605|NCT00991276|144380370|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-5.35|STANDARD_ERROR_OF_MEAN|2.57||0.0396|TWO_SIDED|95.0|-10.44|-0.26||This analysis was step 6 in a step-down procedure (if p-value \< 0.05, then continue to next step) used to control the Type I error rate.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||-0.26|-10.44|0.0396
72378104|NCT01931670|144264688|SUPERIORITY||Difference in LS Mean Change|-1.13|STANDARD_ERROR_OF_MEAN|0.074|<|0.001|TWO_SIDED|||||For an elagolix dose group to be considered statistically significantly better than placebo on a secondary endpoint, the P value must have been ≤ 0.025 for that endpoint, for all higher-ranking secondary endpoints, and for the co-primary endpoints.|mixed-effects model|||Ranked secondary efficacy endpoint 2 of 7.||||< 0.001
72556296|NCT03913377|144643890|EQUIVALENCE|A statistically significant difference in NIBUT/NIKBUT between Test lens and Spectacles was concluded if the upper confidence limit of the 95% CI is below zero or the lower limit is above zero.|LS Mean Difference|-2.79|STANDARD_ERROR_OF_MEAN|0.678|||TWO_SIDED|95.0|-4.14|-1.44|||Mixed Model Analysis|Kenward and Roger method was used for denominator degrees of freedom.|LS Mean difference was calculated as Test minus Control|The null and alternative hypotheses for testing significant difference between Test lens and Spectacles among habitual lens users with respect to NIBUT/NIKBUT.||-1.44|-4.14|
72378105|NCT01931670|144264689|SUPERIORITY||Difference in LS Mean Change|-0.15|STANDARD_ERROR_OF_MEAN|0.056||0.009|TWO_SIDED|||||For an elagolix dose group to be considered statistically significantly better than placebo on a secondary endpoint, the P value must have been ≤ 0.025 for that endpoint, for all higher-ranking secondary endpoints, and for the co-primary endpoints.|mixed-effects model|||Ranked secondary efficacy endpoint 3 of 7.||||0.009
72378106|NCT01931670|144264689|SUPERIORITY||Difference in LS Mean Change|-0.32|STANDARD_ERROR_OF_MEAN|0.056|<|0.001|TWO_SIDED|||||For an elagolix dose group to be considered statistically significantly better than placebo on a secondary endpoint, the P value must have been ≤ 0.025 for that endpoint, for all higher-ranking secondary endpoints, and for the co-primary endpoints.|mixed-effects model|||Ranked secondary efficacy endpoint 3 of 7.||||< 0.001
72378107|NCT01931670|144264690|SUPERIORITY||Difference in LS Mean Change|-0.05|STANDARD_ERROR_OF_MEAN|0.044||0.26|TWO_SIDED|||||For an elagolix dose group to be considered statistically significantly better than placebo on a secondary endpoint, the P value must have been ≤ 0.025 for that endpoint, for all higher-ranking secondary endpoints, and for the co-primary endpoints.|mixed-effects model|||Ranked secondary efficacy endpoint 4 of 7.||||0.26
72378108|NCT01931670|144264690|SUPERIORITY||Difference in LS Mean Change|-0.18|STANDARD_ERROR_OF_MEAN|0.044|<|0.001|TWO_SIDED|||||For an elagolix dose group to be considered statistically significantly better than placebo on a secondary endpoint, the P value must have been ≤ 0.025 for that endpoint, for all higher-ranking secondary endpoints, and for the co-primary endpoints.|mixed-effects model|||Ranked secondary efficacy endpoint 4 of 7.||||< 0.001
72378109|NCT01931670|144264691|SUPERIORITY||Difference in LS Mean Change|-0.08|STANDARD_ERROR_OF_MEAN|0.048||0.088|TWO_SIDED|||||For an elagolix dose group to be considered statistically significantly better than placebo on a secondary endpoint, the P value must have been ≤ 0.025 for that endpoint, for all higher-ranking secondary endpoints, and for the co-primary endpoints.|mixed-effects model|||Ranked secondary efficacy endpoint 5 of 7.||||0.088
72378110|NCT01931670|144264691|SUPERIORITY||Difference in LS Mean Change|-0.21|STANDARD_ERROR_OF_MEAN|0.048|<|0.001|TWO_SIDED|||||For an elagolix dose group to be considered statistically significantly better than placebo on a secondary endpoint, the P value must have been ≤ 0.025 for that endpoint, for all higher-ranking secondary endpoints, and for the co-primary endpoints.|mixed-effects model|||Ranked secondary efficacy endpoint 5 of 7.||||< 0.001
72378111|NCT01931670|144264692|SUPERIORITY||Difference in LS Mean Change|-0.09|STANDARD_ERROR_OF_MEAN|0.067||0.172|TWO_SIDED|||||For an elagolix dose group to be considered statistically significantly better than placebo on a secondary endpoint, the P value must have been ≤ 0.025 for that endpoint, for all higher-ranking secondary endpoints, and for the co-primary endpoints.|mixed-effects model|||Ranked secondary efficacy endpoint 6 of 7.||||0.172
72378112|NCT01931670|144264692|SUPERIORITY||Difference in LS Mean Change|-0.3|STANDARD_ERROR_OF_MEAN|0.067|<|0.001|TWO_SIDED|||||For an elagolix dose group to be considered statistically significantly better than placebo on a secondary endpoint, the P value must have been ≤ 0.025 for that endpoint, for all higher-ranking secondary endpoints, and for the co-primary endpoints.|mixed-effects model|||Ranked secondary efficacy endpoint 6 of 7.||||< 0.001
72378113|NCT01931670|144264693|SUPERIORITY||Difference in LS Mean Change|0.0|STANDARD_ERROR_OF_MEAN|0.03||0.968|TWO_SIDED|||||For an elagolix dose group to be considered statistically significantly better than placebo on a secondary endpoint, the P value must have been ≤ 0.025 for that endpoint, for all higher-ranking secondary endpoints, and for the co-primary endpoints.|mixed-effects model|||Ranked secondary efficacy endpoint 7 of 7.||||0.968
72378114|NCT01931670|144264693|SUPERIORITY||Difference in LS Mean Change|-0.08|STANDARD_ERROR_OF_MEAN|0.03||0.007|TWO_SIDED|||||For an elagolix dose group to be considered statistically significantly better than placebo on a secondary endpoint, the P value must have been ≤ 0.025 for that endpoint, for all higher-ranking secondary endpoints, and for the co-primary endpoints.|mixed-effects model|||Ranked secondary efficacy endpoint 7 of 7.||||0.007
72378115|NCT01931670|144264694|SUPERIORITY||Odds Ratio (OR)|2.361|||<|0.001|TWO_SIDED|97.5|1.507|3.697|||Regression, Logistic|||Month 1||3.697|1.507|< 0.001
72378116|NCT01931670|144264694|SUPERIORITY||Odds Ratio (OR)|4.185|||<|0.001|TWO_SIDED|97.5|2.707|6.469|||Regression, Logistic|||Month 1||6.469|2.707|< 0.001
72378117|NCT01931670|144264694|SUPERIORITY||Odds Ratio (OR)|2.795|||<|0.001|TWO_SIDED|97.5|1.811|4.312|||Regression, Logistic|||Month 2||4.312|1.811|< 0.001
72433606|NCT00991276|144380370|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-4.9|STANDARD_ERROR_OF_MEAN|2.55||0.0568|TWO_SIDED|95.0|-9.95|0.14||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||0.14|-9.95|0.0568
72556297|NCT03913377|144643891|OTHER|Estimated 95% confidence intervals for the point estimates of Test and Control|Mean Proportion|85.59|STANDARD_ERROR_OF_MEAN|1.038|||TWO_SIDED|95.0|43.2|97.89|||Mixed Model Analysis|||Point estimates for Test and Control with 95% confidence intervals||97.89|43.2|
72378118|NCT01931670|144264694|SUPERIORITY||Odds Ratio (OR)|10.378|||<|0.001|TWO_SIDED|97.5|6.615|16.282|||Regression, Logistic|||Month 2||16.282|6.615|< 0.001
72378119|NCT01931670|144264694|SUPERIORITY||Odds Ratio (OR)|3.178|||<|0.001|TWO_SIDED|97.5|2.084|4.845|||Regression, Logistic|||Month 4||4.845|2.084|< 0.001
72378120|NCT01931670|144264694|SUPERIORITY||Odds Ratio (OR)|15.216|||<|0.001|TWO_SIDED|97.5|9.429|24.554|||Regression, Logistic|||Month 4||24.554|9.429|< 0.001
72378121|NCT01931670|144264694|SUPERIORITY||Odds Ratio (OR)|2.548|||<|0.001|TWO_SIDED|97.5|1.683|3.859|||Regression, Logistic|||Month 5||3.859|1.683|< 0.001
72378122|NCT01931670|144264694|SUPERIORITY||Odds Ratio (OR)|14.055|||<|0.001|TWO_SIDED|97.5|8.716|22.664|||Regression, Logistic|||Month 5||22.664|8.716|< 0.001
72378123|NCT01931670|144264694|SUPERIORITY||Odds Ratio (OR)|2.536|||<|0.001|TWO_SIDED|97.5|1.685|3.816|||Regression, Logistic|||Month 6||3.816|1.685|< 0.001
72378124|NCT01931670|144264694|SUPERIORITY||Odds Ratio (OR)|10.106|||<|0.001|TWO_SIDED|97.5|6.434|15.874|||Regression, Logistic|||Month 6||15.874|6.434|< 0.001
72378125|NCT01931670|144264695|SUPERIORITY||Odds Ratio (OR)|1.191||||0.376|TWO_SIDED|97.5|0.765|1.855|||Regression, Logistic|||Month 1||1.855|0.765|0.376
72378126|NCT01931670|144264695|SUPERIORITY||Odds Ratio (OR)|1.376||||0.101|TWO_SIDED|97.5|0.89|2.127|||Regression, Logistic|||Month 1||2.127|0.890|0.101
72378127|NCT01931670|144264695|SUPERIORITY||Odds Ratio (OR)|1.358||||0.088|TWO_SIDED|97.5|0.909|2.029|||Regression, Logistic|||Month 2||2.029|0.909|0.088
72378128|NCT01931670|144264695|SUPERIORITY||Odds Ratio (OR)|2.208|||<|0.001|TWO_SIDED|97.5|1.488|3.278|||Regression, Logistic|||Month 2||3.278|1.488|< 0.001
72378129|NCT01931670|144264695|SUPERIORITY||Odds Ratio (OR)|1.678||||0.003|TWO_SIDED|97.5|1.136|2.477|||Regression, Logistic|||Month 4||2.477|1.136|0.003
72618491|NCT04913675|144768060|NON_INFERIORITY|This outcome measure was analyzed using a hypothetical estimand and assessing non-inferiority of 500 mg IM vs 500 mg IV using a non-inferiority margin of 3.5 percent (%) on the risk difference scale. A pre-specified daily imputation algorithm imputed the missing outcome iteratively for each study day starting with Day 2 and ending at Day 29.|Risk Difference (RD)|1.16|||||TWO_SIDED|95.0|-1.23|3.56|||||Analysis was performed using a binomial regression model with identity link function and with treatment (Sotrovimab 500mg IM, 500mg IV), age (\<65, =\>65 years old) and gender (male, female) as covariates.|||3.56|-1.23|
72378130|NCT01931670|144264695|SUPERIORITY||Odds Ratio (OR)|2.722|||<|0.001|TWO_SIDED|97.5|1.832|4.044|||Regression, Logistic|||Month 4||4.044|1.832|< 0.001
72378131|NCT01931670|144264695|SUPERIORITY||Odds Ratio (OR)|1.537||||0.013|TWO_SIDED|97.5|1.042|2.267|||Regression, Logistic|||Month 5||2.267|1.042|0.013
72378132|NCT01931670|144264695|SUPERIORITY||Odds Ratio (OR)|2.598|||<|0.001|TWO_SIDED|97.5|1.75|3.857|||Regression, Logistic|||Month 5||3.857|1.750|< 0.001
72378133|NCT01931670|144264695|SUPERIORITY||Odds Ratio (OR)|1.565||||0.01|TWO_SIDED|97.5|1.062|2.306|||Regression, Logistic|||Month 6||2.306|1.062|0.01
72378134|NCT01931670|144264695|SUPERIORITY||Odds Ratio (OR)|2.412|||<|0.001|TWO_SIDED|97.5|1.63|3.57|||Regression, Logistic|||Month 6||3.570|1.630|< 0.001
72378135|NCT01931670|144264696|SUPERIORITY||Odds Ratio (OR)|1.028||||0.901|TWO_SIDED|97.5|0.624|1.693|||Regression, Logistic|||Month 1||1.693|0.624|0.901
72378136|NCT01931670|144264696|SUPERIORITY||Odds Ratio (OR)|1.103||||0.65|TWO_SIDED|97.5|0.68|1.789|||Regression, Logistic|||Month 1||1.789|0.680|0.65
72378137|NCT01931670|144264696|SUPERIORITY||Odds Ratio (OR)|1.351||||0.154|TWO_SIDED|97.5|0.841|2.17|||Regression, Logistic|||Month 2||2.170|0.841|0.154
72378138|NCT01931670|144264696|SUPERIORITY||Odds Ratio (OR)|1.871||||0.003|TWO_SIDED|97.5|1.175|2.979|||Regression, Logistic|||Month 2||2.979|1.175|0.003
72378139|NCT01931670|144264696|SUPERIORITY||Odds Ratio (OR)|1.25||||0.294|TWO_SIDED|97.5|0.776|2.013|||Regression, Logistic|||Month 3||2.013|0.776|0.294
72378140|NCT01931670|144264696|SUPERIORITY||Odds Ratio (OR)|1.865||||0.003|TWO_SIDED|97.5|1.163|2.989|||Regression, Logistic|||Month 3||2.989|1.163|0.003
72378141|NCT01931670|144264696|SUPERIORITY||Odds Ratio (OR)|1.145||||0.521|TWO_SIDED|97.5|0.713|1.839|||Regression, Logistic|||Month 4||1.839|0.713|0.521
72378142|NCT01931670|144264696|SUPERIORITY||Odds Ratio (OR)|2.474|||<|0.001|TWO_SIDED|97.5|1.544|3.963|||Regression, Logistic|||Month 4||3.963|1.544|< 0.001
72378143|NCT01931670|144264696|SUPERIORITY||Odds Ratio (OR)|1.262||||0.27|TWO_SIDED|97.5|0.787|2.023|||Regression, Logistic|||Month 5||2.023|0.787|0.27
72378144|NCT01931670|144264696|SUPERIORITY||Odds Ratio (OR)|2.416|||<|0.001|TWO_SIDED|97.5|1.5|3.891|||Regression, Logistic|||Month 5||3.891|1.500|< 0.001
72378145|NCT01931670|144264696|SUPERIORITY||Odds Ratio (OR)|1.013||||0.953|TWO_SIDED|97.5|0.631|1.624|||Regression, Logistic|||Month 6||1.624|0.631|0.953
72378146|NCT01931670|144264696|SUPERIORITY||Odds Ratio (OR)|1.997|||<|0.001|TWO_SIDED|97.5|1.253|3.183|||Regression, Logistic|||Month 6||3.183|1.253|< 0.001
72378147|NCT01931670|144264697|SUPERIORITY||LS Mean of Difference|-0.53|STANDARD_ERROR_OF_MEAN|0.071|<|0.001|TWO_SIDED|97.5|-0.69|-0.37|||mixed-effects model|||Month 1||-0.37|-0.69|< 0.001
72378148|NCT01931670|144264697|SUPERIORITY||LS Mean of Difference|-0.78|STANDARD_ERROR_OF_MEAN|0.071|<|0.001|TWO_SIDED|97.5|-0.94|-0.62|||mixed-effects model|||Month 1||-0.62|-0.94|< 0.001
72378149|NCT01931670|144264697|SUPERIORITY||LS Mean of Difference|-0.44|STANDARD_ERROR_OF_MEAN|0.068|<|0.001|TWO_SIDED|97.5|-0.6|-0.29|||mixed-effects model|||Month 2||-0.29|-0.6|< 0.001
72378150|NCT01931670|144264697|SUPERIORITY||LS Mean of Difference|-1.27|STANDARD_ERROR_OF_MEAN|0.068|<|0.001|TWO_SIDED|97.5|-1.43|-1.12|||mixed-effects model|||Month 2||-1.12|-1.43|< 0.001
72378151|NCT01931670|144264697|SUPERIORITY||LS Mean of Difference|-0.53|STANDARD_ERROR_OF_MEAN|0.068|<|0.001|TWO_SIDED|97.5|-0.68|-0.37|||mixed-effects model|||Month 3||-0.37|-0.68|< 0.001
72378152|NCT01931670|144264697|SUPERIORITY||LS Mean of Difference|-1.25|STANDARD_ERROR_OF_MEAN|0.067|<|0.001|TWO_SIDED|97.5|-1.4|-1.09|||mixed-effects model|||Month 3||-1.09|-1.4|< 0.001
72378153|NCT01931670|144264697|SUPERIORITY||LS Mean of Difference|-0.58|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|97.5|-0.73|-0.42|||mixed-effects model|||Month 4||-0.42|-0.73|< 0.001
72378154|NCT01931670|144264697|SUPERIORITY||LS Mean of Difference|-1.27|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|97.5|-1.42|-1.11|||mixed-effects model|||Month 4||-1.11|-1.42|< 0.001
72378155|NCT01931670|144264697|SUPERIORITY||LS Mean of Difference|-0.49|STANDARD_ERROR_OF_MEAN|0.071|<|0.001|TWO_SIDED|97.5|-0.65|-0.33|||mixed-effects model|||Month 5||-0.33|-0.65|< 0.001
72378156|NCT01931670|144264697|SUPERIORITY||LS Mean of Difference|-1.26|STANDARD_ERROR_OF_MEAN|0.071|<|0.001|TWO_SIDED|97.5|-1.42|-1.1|||mixed-effects model|||Month 5||-1.10|-1.42|< 0.001
72378157|NCT01931670|144264698|SUPERIORITY||LS Mean of Difference|-25.31|STANDARD_ERROR_OF_MEAN|3.669|<|0.001|TWO_SIDED|97.5|-33.55|-17.07|||mixed-effects model|||Month 1||-17.07|-33.55|< 0.001
72378158|NCT01931670|144264698|SUPERIORITY||LS Mean of Difference|-39.32|STANDARD_ERROR_OF_MEAN|3.657|<|0.001|TWO_SIDED|97.5|-47.53|-31.11|||mixed-effects model|||Month 1||-31.11|-47.53|< 0.001
72378159|NCT01931670|144264698|SUPERIORITY||LS Mean of Difference|-21.9|STANDARD_ERROR_OF_MEAN|3.355|<|0.001|TWO_SIDED|97.5|-29.44|-14.36|||mixed-effects model|||Month 2||-14.36|-29.44|< 0.001
72378160|NCT01931670|144264698|SUPERIORITY||LS Mean of Difference|-63.31|STANDARD_ERROR_OF_MEAN|3.365|<|0.001|TWO_SIDED|97.5|-70.87|-55.76|||mixed-effects model|||Month 2||-55.76|-70.87|< 0.001
72378161|NCT01931670|144264698|SUPERIORITY||LS Mean of Difference|-25.15|STANDARD_ERROR_OF_MEAN|3.241|<|0.001|TWO_SIDED|97.5|-32.43|-17.88|||mixed-effects model|||Month 3||-17.88|-32.43|< 0.001
72378162|NCT01931670|144264698|SUPERIORITY||LS Mean of Difference|-61.94|STANDARD_ERROR_OF_MEAN|3.233|<|0.001|TWO_SIDED|97.5|-69.2|-54.68|||mixed-effects model|||Month 3||-54.68|-69.20|< 0.001
72378163|NCT01931670|144264698|SUPERIORITY||LS Mean of Difference|-26.97|STANDARD_ERROR_OF_MEAN|3.344|<|0.001|TWO_SIDED|97.5|-34.48|-19.46|||mixed-effects model|||Month 4||-19.46|-34.48|< 0.001
72378164|NCT01931670|144264698|SUPERIORITY||LS Mean of Difference|-62.37|STANDARD_ERROR_OF_MEAN|3.346|<|0.001|TWO_SIDED|97.5|-69.89|-54.86|||mixed-effects model|||Month 4||-54.86|-69.89|< 0.001
72378165|NCT01931670|144264698|SUPERIORITY||LS Mean of Difference|-23.36|STANDARD_ERROR_OF_MEAN|3.428|<|0.001|TWO_SIDED|97.5|-31.06|-15.66|||mixed-effects model|||Month 5||-15.66|-31.06|< 0.001
72618492|NCT04913675|144768078|NON_INFERIORITY|This outcome measure was analyzed using a hypothetical estimand and assessing non-inferiority of IM dose versus IV using a non-inferiority margin of 3.5% on the risk difference scale. Weekly imputation algorithm imputes the missing outcome iteratively for each week, where missing outcomes at Day 8, 15, 22, 29 are imputed.|Risk Difference (RD)|0.86|||||TWO_SIDED|95.0|-1.56|3.28|||||Post-hoc analysis was performed using a binomial regression model with identify link function and with treatment (Sotrovimab 500 mg IM, 500 mg IV), age (\<65, \>-65 years old), and sex (male, female) as covariates.|||3.28|-1.56|
72378166|NCT01931670|144264698|SUPERIORITY||LS Mean of Difference|-62.9|STANDARD_ERROR_OF_MEAN|3.42|<|0.001|TWO_SIDED|97.5|-70.58|-55.22|||mixed-effects model|||Month 5||-55.22|-70.58|< 0.001
72378167|NCT01931670|144264698|SUPERIORITY||LS Mean of Difference|-25.89|STANDARD_ERROR_OF_MEAN|3.528|<|0.001|TWO_SIDED|97.5|-33.81|-17.97|||mixed-effects model|||Month 6||-17.97|-33.81|< 0.001
72378168|NCT01931670|144264698|SUPERIORITY||LS Mean of Difference|-56.62|STANDARD_ERROR_OF_MEAN|3.522|<|0.001|TWO_SIDED|97.5|-64.53|-48.7|||mixed-effects model|||Month 6||-48.70|-64.53|< 0.001
72378169|NCT01931670|144264699|SUPERIORITY||LS Mean of Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.04||0.549|TWO_SIDED|97.5|-0.11|0.07|||mixed-effects model|||Month 1||0.07|-0.11|0.549
72378170|NCT01931670|144264699|SUPERIORITY||LS Mean of Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.04||0.02|TWO_SIDED|97.5|-0.18|0.0|||mixed-effects model|||Month 1||0.00|-0.18|0.02
72378171|NCT01931670|144264699|SUPERIORITY||LS Mean of Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.044||0.11|TWO_SIDED|97.5|-0.17|0.03|||mixed-effects model|||Month 2||0.03|-0.17|0.11
72378172|NCT01931670|144264699|SUPERIORITY||LS Mean of Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.043|<|0.001|TWO_SIDED|97.5|-0.3|-0.11|||mixed-effects model|||Month 2||-0.11|-0.30|< 0.001
72378173|NCT01931670|144264699|SUPERIORITY||LS Mean of Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.05||0.041|TWO_SIDED|97.5|-0.22|0.01|||mixed-effects model|||Month 3||0.01|-0.22|0.041
72378174|NCT01931670|144264699|SUPERIORITY||LS Mean of Difference|-0.29|STANDARD_ERROR_OF_MEAN|0.05|<|0.001|TWO_SIDED|97.5|-0.41|-0.18|||mixed-effects model|||Month 3||-0.18|-0.41|< 0.001
72378175|NCT01931670|144264699|SUPERIORITY||LS Mean of Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.052||0.081|TWO_SIDED|97.5|-0.21|0.03|||mixed-effects model|||Month 4||0.03|-0.21|0.081
72378176|NCT01931670|144264699|SUPERIORITY||LS Mean of Difference|-0.33|STANDARD_ERROR_OF_MEAN|0.052|<|0.001|TWO_SIDED|97.5|-0.45|-0.22|||mixed-effects model|||Month 4||-0.22|-0.45|<0.001
72378177|NCT01931670|144264699|SUPERIORITY||LS Mean of Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.054||0.062|TWO_SIDED|97.5|-0.22|0.02|||mixed-effects model|||Month 5||0.02|-0.22|0.062
72378178|NCT01931670|144264699|SUPERIORITY||LS Mean of Difference|-0.34|STANDARD_ERROR_OF_MEAN|0.054|<|0.001|TWO_SIDED|97.5|-0.46|-0.22|||mixed-effects model|||Month 5||-0.22|-0.46|< 0.001
72378179|NCT01931670|144264700|SUPERIORITY||LS Mean of Difference|-3.04|STANDARD_ERROR_OF_MEAN|2.94||0.301|TWO_SIDED|97.5|-9.64|3.56|||mixed-effects model|||Month 1||3.56|-9.64|0.301
72378180|NCT01931670|144264700|SUPERIORITY||LS Mean of Difference|-6.43|STANDARD_ERROR_OF_MEAN|2.92||0.028|TWO_SIDED|97.5|-12.99|0.13|||mixed-effects model|||Month 1||0.13|-12.99|0.028
72378181|NCT01931670|144264700|SUPERIORITY||LS Mean of Difference|-5.17|STANDARD_ERROR_OF_MEAN|2.964||0.082|TWO_SIDED|97.5|-11.82|1.49|||mixed-effects model|||Month 2||1.49|-11.82|0.082
72378182|NCT01931670|144264700|SUPERIORITY||LS Mean of Difference|-13.19|STANDARD_ERROR_OF_MEAN|2.956|<|0.001|TWO_SIDED|97.5|-19.83|-6.55|||mixed-effects model|||Month 2||-6.55|-19.83|< 0.001
72378183|NCT01931670|144264700|SUPERIORITY||LS Mean of Difference|-6.84|STANDARD_ERROR_OF_MEAN|3.379||0.043|TWO_SIDED|97.5|-14.43|0.75|||mixed-effects model|||Month 3||0.75|-14.43|0.043
72378184|NCT01931670|144264700|SUPERIORITY||LS Mean of Difference|-19.05|STANDARD_ERROR_OF_MEAN|3.364|<|0.001|TWO_SIDED|97.5|-26.61|-11.49|||mixed-effects model|||Month 3||-11.49|-26.61|< 0.001
72378185|NCT01931670|144264700|SUPERIORITY||LS Mean of Difference|-6.25|STANDARD_ERROR_OF_MEAN|3.473||0.072|TWO_SIDED|97.5|-14.05|1.55|||mixed-effects model|||Month 4||1.55|-14.05|0.072
72378186|NCT01931670|144264700|SUPERIORITY||LS Mean of Difference|-21.58|STANDARD_ERROR_OF_MEAN|3.46|<|0.001|TWO_SIDED|97.5|-29.35|-13.81|||mixed-effects model|||Month 4||-13.81|-29.35|< 0.001
72378187|NCT01931670|144264700|SUPERIORITY||LS Mean of Difference|-6.21|STANDARD_ERROR_OF_MEAN|3.536||0.08|TWO_SIDED|97.5|-14.15|1.73|||mixed-effects model|||Month 5||1.73|-14.15|0.08
72378188|NCT01931670|144264700|SUPERIORITY||LS Mean of Difference|-21.66|STANDARD_ERROR_OF_MEAN|3.52|<|0.001|TWO_SIDED|97.5|-29.56|-13.75|||mixed-effects model|||Month 5||-13.75|-29.56|< 0.001
72378189|NCT01931670|144264700|SUPERIORITY||LS Mean of Difference|-10.83|STANDARD_ERROR_OF_MEAN|3.744||0.004|TWO_SIDED|97.5|-19.24|-2.43|||mixed-effects model|||Month 6||-2.43|-19.24|0.004
72378190|NCT01931670|144264700|SUPERIORITY||LS Mean of Difference|-21.16|STANDARD_ERROR_OF_MEAN|3.729|<|0.001|TWO_SIDED|97.5|-29.54|-12.79|||mixed-effects model|||Month 6||-12.79|-29.54|< 0.001
72378191|NCT01931670|144264701|SUPERIORITY||LS Mean of Difference|0.02|STANDARD_ERROR_OF_MEAN|0.059||0.688|TWO_SIDED|97.5|-0.11|0.16|||mixed-effects model|||Month 1||0.16|-0.11|0.688
72378192|NCT01931670|144264701|SUPERIORITY||LS Mean of Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.058||0.431|TWO_SIDED|97.5|-0.18|0.08|||mixed-effects model|||Month 1||0.08|-0.18|0.431
72378193|NCT01931670|144264701|SUPERIORITY||LS Mean of Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.06||0.277|TWO_SIDED|97.5|-0.2|0.07|||mixed-effects model|||Month 2||0.07|-0.20|0.277
72378194|NCT01931670|144264701|SUPERIORITY||LS Mean of Difference|-0.24|STANDARD_ERROR_OF_MEAN|0.06|<|0.001|TWO_SIDED|97.5|-0.37|-0.1|||mixed-effects model|||Month 2||-0.10|-0.37|< 0.001
72378195|NCT01931670|144264701|SUPERIORITY||LS Mean of Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.071||0.494|TWO_SIDED|97.5|-0.21|0.11|||mixed-effects model|||Month 4||0.11|-0.21|0.494
72378196|NCT01931670|144264701|SUPERIORITY||LS Mean of Difference|-0.27|STANDARD_ERROR_OF_MEAN|0.071|<|0.001|TWO_SIDED|97.5|-0.43|-0.11|||mixed-effects model|||Month 4||-0.11|-0.43|< 0.001
72378197|NCT01931670|144264701|SUPERIORITY||LS Mean of Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.072||0.765|TWO_SIDED|97.5|-0.18|0.14|||mixed-effects model|||Month 5||0.14|-0.18|0.765
72378198|NCT01931670|144264701|SUPERIORITY||LS Mean of Difference|-0.31|STANDARD_ERROR_OF_MEAN|0.073|<|0.001|TWO_SIDED|97.5|-0.47|-0.15|||mixed-effects model|||Month 5||-0.15|-0.47|< 0.001
72378199|NCT01931670|144264701|SUPERIORITY||LS Mean of Difference|-0.06|STANDARD_DEVIATION|0.076||0.468|TWO_SIDED|97.5|-0.23|0.12|||mixed-effects model|||Month 6||0.12|-0.23|0.468
72378200|NCT01931670|144264701|SUPERIORITY||LS Mean of Difference|-0.33|STANDARD_ERROR_OF_MEAN|0.076|<|0.001|TWO_SIDED|97.5|-0.5|-0.16|||mixed-effects model|||Month 6||-0.16|-0.50|< 0.001
72556298|NCT03913377|144643891|OTHER|Estimated 95% confidence intervals for the point estimates of Test and Control|Mean Proportion|84.17|STANDARD_ERROR_OF_MEAN|0.871|||TWO_SIDED|95.0|48.67|96.75|||Mixed Model Analysis|||Point estimates for Test and Control with 95% confidence intervals||96.75|48.67|
72378201|NCT01931670|144264702|SUPERIORITY||LS Mean of Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.04||0.029|TWO_SIDED|97.5|-0.18|0.0|||mixed-effects model|||Month 1||0.00|-0.18|0.029
72378202|NCT01931670|144264702|SUPERIORITY||LS Mean of Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.039||0.004|TWO_SIDED|97.5|-0.2|-0.03|||mixed-effects model|||Month 1||-0.03|-0.20|0.004
72378203|NCT01931670|144264702|SUPERIORITY||LS Mean of Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.042||0.076|TWO_SIDED|97.5|-0.17|0.02|||mixed-effects model|||Month 2||0.02|-0.17|0.076
72378204|NCT01931670|144264702|SUPERIORITY||LS Mean of Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.042|<|0.001|TWO_SIDED|97.5|-0.28|-0.09|||mixed-effects model|||Month 2||-0.09|-0.28|< 0.001
72378205|NCT01931670|144264702|SUPERIORITY||LS Mean of Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.045||0.058|TWO_SIDED|97.5|-0.19|0.02|||mixed-effects model|||Month 4||0.02|-0.19|0.058
72378206|NCT01931670|144264702|SUPERIORITY||LS Mean of Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.045|<|0.001|TWO_SIDED|97.5|-0.32|-0.12|||mixed-effects model|||Month 4||-0.12|-0.32|< 0.001
72378207|NCT01931670|144264702|SUPERIORITY||LS Mean of Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.049||0.284|TWO_SIDED|97.5|-0.16|0.06|||mixed-effects model|||Month 5||0.06|-0.16|0.284
72378208|NCT01931670|144264702|SUPERIORITY||LS Mean of Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.048|<|0.001|TWO_SIDED|97.5|-0.33|-0.11|||mixed-effects model|||Month 5||-0.11|-0.33|< 0.001
72378209|NCT01931670|144264703|SUPERIORITY||LS Mean of Difference|-0.37|STANDARD_ERROR_OF_MEAN|0.099|<|0.001|TWO_SIDED|95.0|-0.56|-0.18|||ANOVA|||Month 1||-0.18|-0.56|< 0.001
72378210|NCT01931670|144264703|SUPERIORITY||LS Mean of Difference|-0.65|STANDARD_ERROR_OF_MEAN|0.099|<|0.001|TWO_SIDED|95.0|-0.84|-0.46|||ANOVA|||Month 1||-0.46|-0.84|< 0.001
72556299|NCT03913377|144643892|OTHER|Estimated 95% confidence intervals for the point estimates of test.|Mean|0.52|STANDARD_ERROR_OF_MEAN|0.053|||TWO_SIDED|95.0|0.4|0.65|||Mixed Model Analysis|Kenward and Rogers Metod was used for degrees of freedom|||Point estimate was calculated for Test.|0.65|0.40|
72378211|NCT01931670|144264703|SUPERIORITY||LS Mean of Difference|-0.62|STANDARD_ERROR_OF_MEAN|0.102|<|0.001|TWO_SIDED|95.0|-0.82|-0.42|||ANOVA|||Month 2||-0.42|-0.82|< 0.001
72378212|NCT01931670|144264703|SUPERIORITY||LS Mean of Difference|-1.09|STANDARD_ERROR_OF_MEAN|0.102|<|0.001|TWO_SIDED|95.0|-1.29|-0.89|||ANOVA|||Month 2||-0.89|-1.29|< 0.001
72378213|NCT01931670|144264703|SUPERIORITY||LS Mean of Difference|-0.63|STANDARD_ERROR_OF_MEAN|0.106|<|0.001|TWO_SIDED|95.0|-0.84|-0.42|||ANOVA|||Month 3||-0.42|-0.84|< 0.001
72378214|NCT01931670|144264703|SUPERIORITY||LS Mean of Difference|-1.14|STANDARD_ERROR_OF_MEAN|0.106|<|0.001|TWO_SIDED|95.0|-1.35|-0.93|||ANOVA|||Month 3||-0.93|-1.35|< 0.001
72378215|NCT01931670|144264703|SUPERIORITY||LS Mean of Difference|-0.62|STANDARD_ERROR_OF_MEAN|0.109|<|0.001|TWO_SIDED|95.0|-0.84|-0.41|||ANOVA|||Month 4||-0.41|-0.84|< 0.001
72378216|NCT01931670|144264703|SUPERIORITY||LS Mean of Difference|-1.21|STANDARD_ERROR_OF_MEAN|0.109|<|0.001|TWO_SIDED|95.0|-1.43|-1.0|||ANOVA|||Month 4||-1.00|-1.43|< 0.001
72378217|NCT01931670|144264703|SUPERIORITY||LS Mean of Difference|-0.79|STANDARD_ERROR_OF_MEAN|0.113|<|0.001|TWO_SIDED|95.0|-1.01|-0.57|||ANOVA|||Month 5||-0.57|-1.01|< 0.001
72378218|NCT01931670|144264703|SUPERIORITY||LS Mean of Difference|-1.24|STANDARD_ERROR_OF_MEAN|0.113|<|0.001|TWO_SIDED|95.0|-1.47|-1.02|||ANOVA|||Month 5||-1.02|-1.47|< 0.001
72556300|NCT03913377|144643892|OTHER|Estimated 95% confidence intervals for the point estimates of Control.|Mean|0.13|STANDARD_ERROR_OF_MEAN|0.036|||TWO_SIDED|95.0|-0.19|0.44|||Mixed Model Analysis|Kenward and Rogers Metod was used for degrees of freedom|||Point estimates were calculated for Control.|0.44|-0.19|
72378219|NCT01931670|144264703|SUPERIORITY||LS Mean of Difference|-0.72|STANDARD_ERROR_OF_MEAN|0.116|<|0.001|TWO_SIDED|95.0|-0.95|-0.49|||ANOVA|||Month 6||-0.49|-0.95|< 0.001
72378220|NCT01931670|144264703|SUPERIORITY||LS Mean of Difference|-1.27|STANDARD_ERROR_OF_MEAN|0.117|<|0.001|TWO_SIDED|95.0|-1.5|-1.04|||ANOVA|||Month 6||-1.04|-1.50|< 0.001
72378221|NCT01931670|144264704|SUPERIORITY||LS Mean of Difference|-0.28|STANDARD_ERROR_OF_MEAN|0.12||0.02|TWO_SIDED|97.5|-0.55|-0.01|||mixed-effects model|||Month 1||-0.01|-0.55|0.02
72378222|NCT01931670|144264704|SUPERIORITY||LS Mean of Difference|-0.45|STANDARD_ERROR_OF_MEAN|0.119|<|0.001|TWO_SIDED|97.5|-0.72|-0.18|||mixed-effects model|||Month 1||-0.18|-0.72|< 0.001
72378223|NCT01931670|144264704|SUPERIORITY||LS Mean of Difference|-0.54|STANDARD_ERROR_OF_MEAN|0.137|<|0.001|TWO_SIDED|97.5|-0.85|-0.23|||mixed-effects model|||Month 2||-0.23|-0.85|< 0.001
72378224|NCT01931670|144264704|SUPERIORITY||LS Mean of Difference|-0.96|STANDARD_ERROR_OF_MEAN|0.137|<|0.001|TWO_SIDED|97.5|-1.27|-0.65|||mixed-effects model|||Month 2||-0.65|-1.27|< 0.001
72378225|NCT01931670|144264704|SUPERIORITY||LS Mean of Difference|-0.58|STANDARD_ERROR_OF_MEAN|0.164|<|0.001|TWO_SIDED|97.5|-0.95|-0.21|||mixed-effects model|||Month 4||-0.21|-0.95|< 0.001
72378226|NCT01931670|144264704|SUPERIORITY||LS Mean of Difference|-1.36|STANDARD_ERROR_OF_MEAN|0.164|<|0.001|TWO_SIDED|97.5|-1.72|-0.99|||mixed-effects model|||Month 4||-0.99|-1.72|< 0.001
72378227|NCT01931670|144264704|SUPERIORITY||LS Mean of Difference|-0.61|STANDARD_ERROR_OF_MEAN|0.168|<|0.001|TWO_SIDED|97.5|-0.99|-0.23|||mixed-effects model|||Month 5||-0.23|-0.99|< 0.001
72378228|NCT01931670|144264704|SUPERIORITY||LS Mean of Difference|-1.37|STANDARD_ERROR_OF_MEAN|0.168|<|0.001|TWO_SIDED|97.5|-1.75|-1.0|||mixed-effects model|||Month 5||-1.00|-1.75|< 0.001
72378229|NCT01931670|144264704|SUPERIORITY||LS Mean of Difference|-0.69|STANDARD_ERROR_OF_MEAN|0.175|<|0.001|TWO_SIDED|97.5|-1.08|-0.3|||mixed-effects model|||Month 6||-0.30|-1.08|< 0.001
72378230|NCT01931670|144264704|SUPERIORITY||LS Mean of Difference|-1.28|STANDARD_ERROR_OF_MEAN|0.175|<|0.001|TWO_SIDED|97.5|-1.67|-0.89|||mixed-effects model|||Month 6||-0.89|-1.67|< 0.001
72378231|NCT01931670|144264705|SUPERIORITY||Difference in LS Means|-4.2|STANDARD_ERROR_OF_MEAN|1.55||0.007|TWO_SIDED|95.0|-7.25|-1.16|||ANCOVA|||Month 1||-1.16|-7.25|0.007
72378232|NCT01931670|144264705|SUPERIORITY||Difference in LS Means|-7.55|STANDARD_ERROR_OF_MEAN|1.55|<|0.001|TWO_SIDED|95.0|-10.6|-4.5|||ANCOVA|||Month 1||-4.50|-10.6|< 0.001
72378233|NCT01931670|144264705|SUPERIORITY||Difference in LS Means|-7.33|STANDARD_ERROR_OF_MEAN|1.74|<|0.001|TWO_SIDED|95.0|-10.75|-3.91|||ANCOVA|||Month 3||-3.91|-10.75|< 0.001
72378234|NCT01931670|144264705|SUPERIORITY||Difference in LS Means|-15.43|STANDARD_ERROR_OF_MEAN|1.75|<|0.001|TWO_SIDED|95.0|-18.87|-11.99|||ANCOVA|||Month 3||-11.99|-18.87|< 0.001
72378235|NCT01931670|144264705|SUPERIORITY||Difference in LS Means|-8.7|STANDARD_ERROR_OF_MEAN|2.09|<|0.001|TWO_SIDED|95.0|-12.81|-4.6|||ANCOVA|||Month 6||-4.60|-12.81|< 0.001
72378236|NCT01931670|144264705|SUPERIORITY||Difference in LS Means|-16.92|STANDARD_ERROR_OF_MEAN|2.07|<|0.001|TWO_SIDED|95.0|-20.98|-12.86|||ANCOVA|||Month 6||-12.86|-20.98|< 0.001
72378237|NCT01931670|144264706|SUPERIORITY||Difference in LS Means|-0.57|STANDARD_ERROR_OF_MEAN|1.95||0.77|TWO_SIDED|95.0|-4.4|3.26|||ANCOVA|||Month 1||3.26|-4.40|0.77
72378238|NCT01931670|144264706|SUPERIORITY||Difference in LS Means|-4.4|STANDARD_ERROR_OF_MEAN|1.93||0.023|TWO_SIDED|95.0|-8.19|-0.61|||ANCOVA|||Month 1||-0.61|-8.19|0.023
72378239|NCT01931670|144264706|SUPERIORITY||Difference in LS Means|-2.74|STANDARD_ERROR_OF_MEAN|2.42||0.257|TWO_SIDED|95.0|-7.5|2.01|||ANCOVA|||Month 3||2.01|-7.50|0.257
72378240|NCT01931670|144264706|SUPERIORITY||Difference in LS Means|-10.69|STANDARD_ERROR_OF_MEAN|2.38|<|0.001|TWO_SIDED|95.0|-15.37|-6.01|||ANCOVA|||Month 3||-6.01|-15.37|< 0.001
72556301|NCT03913377|144643893|OTHER|Estimated 95% confidence intervals for the point estimates of Test.|Mean Proportion|30.7|STANDARD_ERROR_OF_MEAN|19.87|||TWO_SIDED|95.0|6.5|73.8|||Mixed Model Analysis||Point estimates were calculated for Test|||73.8|6.5|
72378241|NCT01931670|144264706|SUPERIORITY||Difference in LS Means|-2.93|STANDARD_ERROR_OF_MEAN|2.91||0.315|TWO_SIDED|95.0|-8.66|2.8|||ANCOVA|||Month 6||2.80|-8.66|0.315
72378242|NCT01931670|144264706|SUPERIORITY||Difference in LS Means|-14.1|STANDARD_ERROR_OF_MEAN|2.82|<|0.001|TWO_SIDED|95.0|-19.64|-8.55|||ANCOVA|||Month 6||-8.55|-19.64|< 0.001
72378243|NCT01931670|144264707|SUPERIORITY||Difference in LS Means|-1.01|STANDARD_ERROR_OF_MEAN|0.43||0.019|TWO_SIDED|95.0|-1.86|-0.17|||ANCOVA|||Month 1||-0.17|-1.86|0.019
72378244|NCT01931670|144264707|SUPERIORITY||Difference in LS Means|-0.95|STANDARD_ERROR_OF_MEAN|0.433||0.028|TWO_SIDED|95.0|-1.8|-0.1|||ANCOVA|||Month 1||-0.10|-1.80|0.028
72378245|NCT01931670|144264707|SUPERIORITY||Difference in LS Means|-0.98|STANDARD_ERROR_OF_MEAN|0.397||0.014|TWO_SIDED|95.0|-1.76|-0.2|||ANCOVA|||Month 2||-0.20|-1.76|0.014
72378246|NCT01931670|144264707|SUPERIORITY||Difference in LS Means|-1.44|STANDARD_ERROR_OF_MEAN|0.397|<|0.001|TWO_SIDED|95.0|-2.22|-0.65|||ANCOVA|||Month 2||-0.65|-2.22|< 0.001
72378247|NCT01931670|144264707|SUPERIORITY||Difference in LS Means|-0.67|STANDARD_ERROR_OF_MEAN|0.432||0.121|TWO_SIDED|95.0|-1.52|0.18|||ANCOVA|||Month 3||0.18|-1.52|0.121
72378248|NCT01931670|144264707|SUPERIORITY||Difference in LS Means|-1.41|STANDARD_ERROR_OF_MEAN|0.431||0.001|TWO_SIDED|95.0|-2.25|-0.56|||ANCOVA|||Month 3||-0.56|-2.25|0.001
72378249|NCT01931670|144264707|SUPERIORITY||Difference in LS Means|-1.25|STANDARD_ERROR_OF_MEAN|0.561||0.026|TWO_SIDED|95.0|-2.35|-0.15|||ANCOVA|||Month 4||-0.15|-2.35|0.026
72378250|NCT01931670|144264707|SUPERIORITY||Difference in LS Means|-1.48|STANDARD_ERROR_OF_MEAN|0.555||0.008|TWO_SIDED|95.0|-2.57|-0.39|||ANCOVA|||Month 4||-0.39|-2.57|0.008
72378251|NCT01931670|144264707|SUPERIORITY||Difference in LS Means|-0.73|STANDARD_ERROR_OF_MEAN|0.327||0.027|TWO_SIDED|95.0|-1.37|-0.08|||ANCOVA|||Month 5||-0.08|-1.37|0.027
72378252|NCT01931670|144264707|SUPERIORITY||Difference in LS Means|-1.11|STANDARD_ERROR_OF_MEAN|0.327|<|0.001|TWO_SIDED|95.0|-1.75|-0.47|||ANCOVA|||Month 5||-0.47|-1.75|< 0.001
72378253|NCT01931670|144264707|SUPERIORITY||Difference in LS Means|-0.57|STANDARD_ERROR_OF_MEAN|0.391||0.143|TWO_SIDED|95.0|-1.34|0.2|||ANCOVA|||Month 6||0.20|-1.34|0.143
72378254|NCT01931670|144264707|SUPERIORITY||Difference in LS Means|-0.91|STANDARD_ERROR_OF_MEAN|0.385||0.019|TWO_SIDED|95.0|-1.67|-0.15|||ANCOVA|||Month 6||-0.15|-1.67|0.019
72378255|NCT01931670|144264708|SUPERIORITY||Difference in LS Means|-0.63|STANDARD_ERROR_OF_MEAN|0.415||0.131|TWO_SIDED|95.0|-1.44|0.19|||ANCOVA|||Month 1||0.19|-1.44|0.131
72378256|NCT01931670|144264708|SUPERIORITY||Difference in LS Means|-0.85|STANDARD_ERROR_OF_MEAN|0.409||0.037|TWO_SIDED|95.0|-1.65|-0.05|||ANCOVA|||Month 1||-0.05|-1.65|0.037
72378257|NCT01931670|144264708|SUPERIORITY||Difference in LS Means|-1.12|STANDARD_ERROR_OF_MEAN|0.423||0.008|TWO_SIDED|95.0|-1.96|-0.29|||ANCOVA|||Month 2||-0.29|-1.96|0.008
72378258|NCT01931670|144264708|SUPERIORITY||Difference in LS Means|-1.44|STANDARD_ERROR_OF_MEAN|0.426|<|0.001|TWO_SIDED|95.0|-2.27|-0.6|||ANCOVA|||Month 2||-0.60|-2.27|< 0.001
72378259|NCT01931670|144264708|SUPERIORITY||Difference in LS Means|-0.91|STANDARD_ERROR_OF_MEAN|0.434||0.036|TWO_SIDED|95.0|-1.76|-0.06|||ANCOVA|||Month 3||-0.06|-1.76|0.036
72378260|NCT01931670|144264708|SUPERIORITY||Difference in LS Means|-0.91|STANDARD_ERROR_OF_MEAN|0.431||0.035|TWO_SIDED|95.0|-1.76|-0.06|||ANCOVA|||Month 3||-0.06|-1.76|0.035
72378261|NCT01931670|144264708|SUPERIORITY||Difference in LS Means|-0.34|STANDARD_ERROR_OF_MEAN|0.453||0.452|TWO_SIDED|95.0|-1.23|0.55|||ANCOVA|||Month 4||0.55|-1.23|0.452
72378262|NCT01931670|144264708|SUPERIORITY||Difference in LS Means|-1.33|STANDARD_ERROR_OF_MEAN|0.432||0.002|TWO_SIDED|95.0|-2.18|-0.48|||ANCOVA|||Month 4||-0.48|-2.18|0.002
72378263|NCT01931670|144264708|SUPERIORITY||Difference in LS Means|-1.12|STANDARD_ERROR_OF_MEAN|0.443||0.012|TWO_SIDED|95.0|-1.99|-0.25|||ANCOVA|||Month 5||-0.25|-1.99|0.012
72378264|NCT01931670|144264708|SUPERIORITY||Difference in LS Means|-1.64|STANDARD_ERROR_OF_MEAN|0.439|<|0.001|TWO_SIDED|95.0|-2.5|-0.78|||ANCOVA|||Month 5||-0.78|-2.5|< 0.001
72378265|NCT01931670|144264708|SUPERIORITY||Difference in LS Means|-0.73|STANDARD_ERROR_OF_MEAN|0.478||0.13|TWO_SIDED|95.0|-1.67|0.21|||ANCOVA|||Month 6||0.21|-1.67|0.13
72378266|NCT01931670|144264708|SUPERIORITY||Difference in LS Means|-1.45|STANDARD_ERROR_OF_MEAN|0.454||0.001|TWO_SIDED|95.0|-2.34|-0.56|||ANCOVA|||Month 6||-0.56|-2.34|0.001
72378267|NCT01931670|144264709|SUPERIORITY||Difference in LS Means|-1.34|STANDARD_ERROR_OF_MEAN|1.01||0.186|TWO_SIDED|95.0|-3.32|0.65|||ANCOVA|||Month 1||0.65|-3.32|0.186
72378268|NCT01931670|144264709|SUPERIORITY||Difference in LS Means|-3.09|STANDARD_ERROR_OF_MEAN|1.013||0.002|TWO_SIDED|95.0|-5.08|-1.1|||ANCOVA|||Month 1||-1.10|-5.08|0.002
72378269|NCT01931670|144264709|SUPERIORITY||Difference in LS Means|-1.31|STANDARD_ERROR_OF_MEAN|1.005||0.195|TWO_SIDED|95.0|-3.28|0.67|||ANCOVA|||Month 2||0.67|-3.28|0.195
72378270|NCT01931670|144264709|SUPERIORITY||Difference in LS Means|-3.65|STANDARD_ERROR_OF_MEAN|1.007|<|0.001|TWO_SIDED|95.0|-5.63|-1.67|||ANCOVA|||Month 2||-1.67|-5.63|< 0.001
72378271|NCT01931670|144264709|SUPERIORITY||Difference in LS Means|-2.03|STANDARD_ERROR_OF_MEAN|1.02||0.047|TWO_SIDED|95.0|-4.03|-0.02|||ANCOVA|||Month 3||-0.02|-4.03|0.047
72378272|NCT01931670|144264709|SUPERIORITY||Difference in LS Means|-3.2|STANDARD_ERROR_OF_MEAN|1.021||0.002|TWO_SIDED|95.0|-5.21|-1.19|||ANCOVA|||Month 3||-1.19|-5.21|0.002
72378273|NCT01931670|144264709|SUPERIORITY||Difference in LS Means|-1.63|STANDARD_ERROR_OF_MEAN|0.998||0.103|TWO_SIDED|95.0|-3.59|0.33|||ANCOVA|||Month 4||0.33|-3.59|0.103
72378274|NCT01931670|144264709|SUPERIORITY||Difference in LS Means|-4.78|STANDARD_ERROR_OF_MEAN|0.99|<|0.001|TWO_SIDED|95.0|-6.72|-2.83|||ANCOVA|||Month 4||-2.83|-6.72|< 0.001
72378275|NCT01931670|144264709|SUPERIORITY||Difference in LS Means|-2.29|STANDARD_ERROR_OF_MEAN|0.97||0.019|TWO_SIDED|95.0|-4.2|-0.38|||ANCOVA|||Month 5||-0.38|-4.20|0.019
72556302|NCT03913377|144643893|OTHER|Estimated 95% confidence intervals for the point estimates of Control.|Mean Proportion|27.9|STANDARD_ERROR_OF_MEAN|18.17|||TWO_SIDED|95.0|6.1|69.8|||Mixed Model Analysis||Point estimates were calculated for Control.|||69.8|6.1|
72378276|NCT01931670|144264709|SUPERIORITY||Difference in LS Means|-5.14|STANDARD_ERROR_OF_MEAN|0.975|<|0.001|TWO_SIDED|95.0|-7.06|-3.22|||ANCOVA|||Month 5||-3.22|-7.06|< 0.001
72378277|NCT01931670|144264709|SUPERIORITY||Difference in LS Means|-0.97|STANDARD_ERROR_OF_MEAN|1.112||0.383|TWO_SIDED|95.0|-3.16|1.22|||ANCOVA|||Month 6||1.22|-3.16|0.383
72378278|NCT01931670|144264709|SUPERIORITY||Difference in LS Means|-3.02|STANDARD_ERROR_OF_MEAN|1.092||0.006|TWO_SIDED|95.0|-5.17|-0.87|||ANCOVA|||Month 6||-0.87|-5.17|0.006
72378279|NCT01931670|144264710|SUPERIORITY||Difference in LS Means|0.01|STANDARD_ERROR_OF_MEAN|0.422||0.975|TWO_SIDED|95.0|-0.81|0.84|||ANCOVA|||Month 1||0.84|-0.81|0.975
72378280|NCT01931670|144264710|SUPERIORITY||Difference in LS Means|-0.02|STANDARD_ERROR_OF_MEAN|0.415||0.969|TWO_SIDED|95.0|-0.83|0.8|||ANCOVA|||Month 1||0.80|-0.83|0.969
72378281|NCT01931670|144264710|SUPERIORITY||Difference in LS Means|-0.22|STANDARD_ERROR_OF_MEAN|0.389||0.569|TWO_SIDED|95.0|-0.99|0.54|||ANCOVA|||Month 2||0.54|-0.99|0.569
72378282|NCT01931670|144264710|SUPERIORITY||Difference in LS Means|-0.4|STANDARD_ERROR_OF_MEAN|0.393||0.311|TWO_SIDED|95.0|-1.17|0.37|||ANCOVA|||Month 2||0.37|-1.17|0.311
72378283|NCT01931670|144264710|SUPERIORITY||Difference in LS Means|0.43|STANDARD_ERROR_OF_MEAN|0.505||0.398|TWO_SIDED|95.0|-0.56|1.42|||ANCOVA|||Month 3||1.42|-0.56|0.398
72378284|NCT01931670|144264710|SUPERIORITY||Difference in LS Means|-0.15|STANDARD_ERROR_OF_MEAN|0.505||0.761|TWO_SIDED|95.0|-1.15|0.84|||ANCOVA|||Month 3||0.84|-1.15|0.761
72378285|NCT01931670|144264710|SUPERIORITY||Difference in LS Means|0.08|STANDARD_ERROR_OF_MEAN|0.491||0.874|TWO_SIDED|95.0|-0.89|1.04|||ANCOVA|||Month 4||1.04|-0.89|0.874
72378286|NCT01931670|144264710|SUPERIORITY||Difference in LS Means|-0.93|STANDARD_ERROR_OF_MEAN|0.468||0.048|TWO_SIDED|95.0|-1.85|-0.01|||ANCOVA|||Month 4||-0.01|-1.85|0.048
72378287|NCT01931670|144264710|SUPERIORITY||Difference in LS Means|-0.89|STANDARD_ERROR_OF_MEAN|0.635||0.16|TWO_SIDED|95.0|-2.14|0.35|||ANCOVA|||Month 5||0.35|-2.14|0.16
72378288|NCT01931670|144264710|SUPERIORITY||Difference in LS Means|-0.9|STANDARD_ERROR_OF_MEAN|0.63||0.152|TWO_SIDED|95.0|-2.14|0.33|||ANCOVA|||Month 5||0.33|-2.14|0.152
72378289|NCT01931670|144264710|SUPERIORITY||Difference in LS Means|-0.83|STANDARD_ERROR_OF_MEAN|0.498||0.095|TWO_SIDED|95.0|-1.81|0.15|||ANCOVA|||Month 6||0.15|-1.81|0.095
72378290|NCT01931670|144264710|SUPERIORITY||Difference in LS Means|-0.86|STANDARD_ERROR_OF_MEAN|0.474||0.071|TWO_SIDED|95.0|-1.79|0.07|||ANCOVA|||Month 6||0.07|-1.79|0.071
72378291|NCT01931670|144264711|SUPERIORITY||Difference in LS Means|-1.83|STANDARD_ERROR_OF_MEAN|1.106||0.098|TWO_SIDED|95.0|-4.01|0.34|||ANCOVA|||Month 1||0.34|-4.01|0.098
72378292|NCT01931670|144264711|SUPERIORITY||Difference in LS Means|-3.72|STANDARD_ERROR_OF_MEAN|1.113|<|0.001|TWO_SIDED|95.0|-5.91|-1.54|||ANCOVA|||Month 1||-1.54|-5.91|< 0.001
72378293|NCT01931670|144264711|SUPERIORITY||Difference in LS Means|-2.02|STANDARD_ERROR_OF_MEAN|1.091||0.065|TWO_SIDED|95.0|-4.16|0.13|||ANCOVA|||Month 2||0.13|-4.16|0.065
72378294|NCT01931670|144264711|SUPERIORITY||Difference in LS Means|-5.1|STANDARD_ERROR_OF_MEAN|1.089|<|0.001|TWO_SIDED|95.0|-7.24|-2.96|||ANCOVA|||Month 2||-2.96|-7.24|< 0.001
72378295|NCT01931670|144264711|SUPERIORITY||Difference in LS Means|-2.65|STANDARD_ERROR_OF_MEAN|1.14||0.02|TWO_SIDED|95.0|-4.89|-0.41|||ANCOVA|||Month 3||-0.41|-4.89|0.02
72378296|NCT01931670|144264711|SUPERIORITY||Difference in LS Means|-4.64|STANDARD_ERROR_OF_MEAN|1.135|<|0.001|TWO_SIDED|95.0|-6.87|-2.41|||ANCOVA|||Month 3||-2.41|-6.87|< 0.001
72378297|NCT01931670|144264711|SUPERIORITY||Difference in LS Means|-2.72|STANDARD_ERROR_OF_MEAN|1.138||0.017|TWO_SIDED|95.0|-4.95|-0.48|||ANCOVA|||Month 4||-0.48|-4.95|0.017
72618493|NCT04913675|144768081|EQUIVALENCE|IM dose was assessed for equivalence to IV based on the two-sided 90% confidence interval for the treatment ratio falling within equivalence bounds of 0.5 to 2.0.|Ratio of least square(LS) geometric mean|1.04|||||TWO_SIDED|90.0|1.0|1.07|||||LS geometric mean was calculated for 500mg IV versus IM by using an Analysis of Covariance (ANCOVA) Model with treatment group (sotrovimab 500mg IM, 500mg IV), age (\<65, =\>65 years old), gender (male, female) and Baseline viral load as covariates.|||1.07|1.00|
72378298|NCT01931670|144264711|SUPERIORITY||Difference in LS Means|-6.27|STANDARD_ERROR_OF_MEAN|1.124|<|0.001|TWO_SIDED|95.0|-8.48|-4.06|||ANCOVA|||Month 4||-4.06|-8.48|< 0.001
72378299|NCT01931670|144264711|SUPERIORITY||Difference in LS Means|-2.49|STANDARD_ERROR_OF_MEAN|1.095||0.023|TWO_SIDED|95.0|-4.64|-0.34|||ANCOVA|||Month 5||-0.34|-4.64|0.023
72378300|NCT01931670|144264711|SUPERIORITY||Difference in LS Means|-5.83|STANDARD_ERROR_OF_MEAN|1.095|<|0.001|TWO_SIDED|95.0|-7.98|-3.68|||ANCOVA|||Month 5||-3.68|-7.98|< 0.001
72378301|NCT01931670|144264711|SUPERIORITY||Difference in LS Means|-1.28|STANDARD_ERROR_OF_MEAN|1.264||0.311|TWO_SIDED|95.0|-3.77|1.2|||ANCOVA|||Month 6||1.20|-3.77|0.311
72378302|NCT01931670|144264711|SUPERIORITY||Difference in LS Means|-3.97|STANDARD_ERROR_OF_MEAN|1.241||0.001|TWO_SIDED|95.0|-6.42|-1.53|||ANCOVA|||Month 6||-1.53|-6.42|0.001
72378303|NCT01931670|144264712|SUPERIORITY||Difference in LS Means|-0.6|STANDARD_ERROR_OF_MEAN|0.62||0.335|TWO_SIDED|95.0|-1.81|0.62|||ANCOVA|||Month 1||0.62|-1.81|0.335
72378304|NCT01931670|144264712|SUPERIORITY||Difference in LS Means|-0.72|STANDARD_ERROR_OF_MEAN|0.611||0.242|TWO_SIDED|95.0|-1.91|0.48|||ANCOVA|||Month 1||0.48|-1.91|0.242
72378305|NCT01931670|144264712|SUPERIORITY||Difference in LS Means|-1.33|STANDARD_ERROR_OF_MEAN|0.652||0.042|TWO_SIDED|95.0|-2.61|-0.05|||ANCOVA|||Month 2||-0.05|-2.61|0.042
72378306|NCT01931670|144264712|SUPERIORITY||Difference in LS Means|-1.77|STANDARD_ERROR_OF_MEAN|0.656||0.007|TWO_SIDED|95.0|-3.06|-0.48|||ANCOVA|||Month 2||-0.48|-3.06|0.007
72378307|NCT01931670|144264712|SUPERIORITY||Difference in LS Means|-0.48|STANDARD_ERROR_OF_MEAN|0.71||0.503|TWO_SIDED|95.0|-1.87|0.92|||ANCOVA|||Month 3||0.92|-1.87|0.503
72378308|NCT01931670|144264712|SUPERIORITY||Difference in LS Means|-0.97|STANDARD_ERROR_OF_MEAN|0.707||0.169|TWO_SIDED|95.0|-2.36|0.41|||ANCOVA|||Month 3||0.41|-2.36|0.169
72378309|NCT01931670|144264712|SUPERIORITY||Difference in LS Means|-0.31|STANDARD_ERROR_OF_MEAN|0.737||0.675|TWO_SIDED|95.0|-1.76|1.14|||ANCOVA|||Month 4||1.14|-1.76|0.675
72378310|NCT01931670|144264712|SUPERIORITY||Difference in LS Means|-2.17|STANDARD_ERROR_OF_MEAN|0.703||0.002|TWO_SIDED|95.0|-3.55|-0.79|||ANCOVA|||Month 4||-0.79|-3.55|0.002
72378311|NCT01931670|144264712|SUPERIORITY||Difference in LS Means|-2.04|STANDARD_ERROR_OF_MEAN|0.856||0.017|TWO_SIDED|95.0|-3.72|-0.36|||ANCOVA|||Month 5||-0.36|-3.72|0.017
72618494|NCT01026038|144768103|SUPERIORITY_OR_OTHER||GMC ratio|0.81|||||TWO_SIDED|95.0|0.61|1.07||||||Serotype 4: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||1.07|0.61|
72378312|NCT01931670|144264712|SUPERIORITY||Difference in LS Means|-2.54|STANDARD_ERROR_OF_MEAN|0.848||0.003|TWO_SIDED|95.0|-4.21|-0.87|||ANCOVA|||Month 5||-0.87|-4.21|0.003
72378313|NCT01931670|144264712|SUPERIORITY||Difference in LS Means|-1.59|STANDARD_ERROR_OF_MEAN|0.778||0.042|TWO_SIDED|95.0|-3.12|-0.06|||ANCOVA|||Month 6||-0.06|-3.12|0.042
72378314|NCT01931670|144264712|SUPERIORITY||Difference in LS Means|-2.28|STANDARD_ERROR_OF_MEAN|0.738||0.002|TWO_SIDED|95.0|-3.73|-0.83|||ANCOVA|||Month 6||-0.83|-3.73|0.002
72378315|NCT01992159|144264753|SUPERIORITY||Treatment Difference|7.5|||<|0.0001|ONE_SIDED|95.0|6.5|||P-values were adjusted for multiplicity using a combination of a sequential test procedure and Hochberg's method to control type 1 error for the primary endpoint.|Repeated Measures Model|||The primary analysis was based on a repeated measures model with the percent change from baseline at months 6 and 12 in BMD of the lumbar spine as the dependent variable, and baseline BMD, machine type, interaction of baseline BMD and machine type, visit (categorical), treatment (categorical), and interaction of treatment and visit as the independent variables; using an unstructured variance covariance structure.|||6.5|< 0.0001
72378316|NCT01992159|144264753|SUPERIORITY||Treatment Difference|12.4|||<|0.0001|ONE_SIDED|95.0|11.1|||P-values were adjusted for multiplicity using a combination of a sequential test procedure and Hochberg's method to control type 1 error for the primary endpoint.|Repeated Measures Model|||The primary analysis was based on a repeated measures model with the percent change from baseline at months 6 and 12 in BMD of the lumbar spine as the dependent variable, and baseline BMD, machine type, interaction of baseline BMD and machine type, visit (categorical), treatment (categorical), and interaction of treatment and visit as the independent variables; using an unstructured variance covariance structure.|||11.1|< 0.0001
72378317|NCT01992159|144264753|SUPERIORITY||Treatment Difference|16.0|||<|0.0001|ONE_SIDED|95.0|14.6|||One-sided p-values were adjusted for multiplicity using a combination of a sequential test procedure and Hochberg's method to control type 1 error for the primary endpoint.|Repeated Measures Model|||The primary analysis was based on a repeated measures model with the percent change from baseline at months 6 and 12 in BMD of the lumbar spine as the dependent variable, and baseline BMD, machine type, interaction of baseline BMD and machine type, visit (categorical), treatment (categorical), and interaction of treatment and visit as the independent variables; using an unstructured variance covariance structure.|||14.6|< 0.0001
72378318|NCT01992159|144264754|SUPERIORITY||Treatment Difference|5.3|||<|0.0001|ONE_SIDED|95.0|4.4||||Repeated Measures Model|||The analysis was based on a repeated measures model with the percent change from baseline at months 6 and 12 in BMD of the lumbar spine as the dependent variable, and baseline BMD, machine type, interaction of baseline BMD and machine type, visit (categorical), treatment (categorical), and interaction of treatment and visit as the independent variables; using an unstructured variance covariance structure.|||4.4|< 0.0001
72378319|NCT01992159|144264754|SUPERIORITY||Treatment Difference|9.0|||<|0.0001|ONE_SIDED|95.0|8.0||||Repeated Measures Model|||The analysis was based on a repeated measures model with the percent change from baseline at months 6 and 12 in BMD of the lumbar spine as the dependent variable, and baseline BMD, machine type, interaction of baseline BMD and machine type, visit (categorical), treatment (categorical), and interaction of treatment and visit as the independent variables; using an unstructured variance covariance structure.|||8.0|< 0.0001
72378320|NCT01992159|144264754|SUPERIORITY||Treatment Difference|11.9|||<|0.0001|ONE_SIDED|95.0|10.6||||Repeated Measures Model|||The analysis was based on a repeated measures model with the percent change from baseline at months 6 and 12 in BMD of the lumbar spine as the dependent variable, and baseline BMD, machine type, interaction of baseline BMD and machine type, visit (categorical), treatment (categorical), and interaction of treatment and visit as the independent variables; using an unstructured variance covariance structure.|||10.6|< 0.0001
72378321|NCT01992159|144264755|SUPERIORITY||Treatment Difference|0.6||||0.125|ONE_SIDED|95.0|-0.3||||Repeated Measures Model|||The analysis was based on a repeated measures model with the percent change from baseline at months 6 and 12 in BMD of the total hip as the dependent variable, and baseline BMD, machine type, interaction of baseline BMD and machine type, visit (categorical), treatment (categorical), and interaction of treatment and visit as the independent variables; using an unstructured variance covariance structure.|||-0.3|0.1250
72378322|NCT01992159|144264755|SUPERIORITY||Treatment Difference|1.7||||0.0002|ONE_SIDED|95.0|0.9||||Repeated Measures Model|||The analysis was based on a repeated measures model with the percent change from baseline at months 6 and 12 in BMD of the total hip as the dependent variable, and baseline BMD, machine type, interaction of baseline BMD and machine type, visit (categorical), treatment (categorical), and interaction of treatment and visit as the independent variables; using an unstructured variance covariance structure.|||0.9|0.0002
72378323|NCT01992159|144264755|SUPERIORITY||Treatment Difference|2.6|||<|0.0001|ONE_SIDED|95.0|1.7||||Repeated Measures Model|||The analysis was based on a repeated measures model with the percent change from baseline at months 6 and 12 in BMD of the total hip as the dependent variable, and baseline BMD, machine type, interaction of baseline BMD and machine type, visit (categorical), treatment (categorical), and interaction of treatment and visit as the independent variables; using an unstructured variance covariance structure.|||1.7|< 0.0001
72378324|NCT01992159|144264756|SUPERIORITY||Treatment Difference|1.5||||0.0012|ONE_SIDED|95.0|0.7||||Repeated Measures Model|||The analysis was based on a repeated measures model with the percent change from baseline at months 6 and 12 in BMD of the total hip as the dependent variable, and baseline BMD, machine type, interaction of baseline BMD and machine type, visit (categorical), treatment (categorical), and interaction of treatment and visit as the independent variables; using an unstructured variance covariance structure.|||0.7|0.0012
72378325|NCT01992159|144264756|SUPERIORITY||Treatment Difference|2.6|||<|0.0001|ONE_SIDED|95.0|1.8||||Repeated Measures Model|||The analysis was based on a repeated measures model with the percent change from baseline at months 6 and 12 in BMD of the total hip as the dependent variable, and baseline BMD, machine type, interaction of baseline BMD and machine type, visit (categorical), treatment (categorical), and interaction of treatment and visit as the independent variables; using an unstructured variance covariance structure.|||1.8|< 0.0001
72378326|NCT01992159|144264756|SUPERIORITY||Treatment Difference|4.1|||<|0.0001|ONE_SIDED|95.0|3.3||||Repeated Measures Model|||The analysis was based on a repeated measures model with the percent change from baseline at months 6 and 12 in BMD of the total hip as the dependent variable, and baseline BMD, machine type, interaction of baseline BMD and machine type, visit (categorical), treatment (categorical), and interaction of treatment and visit as the independent variables; using an unstructured variance covariance structure.|||3.3|< 0.0001
72378327|NCT01992159|144264757|SUPERIORITY||Treatment Difference|0.3||||0.2846|ONE_SIDED|95.0|-0.6||||Repeated Measures Model|||The analysis was based on a repeated measures model with the percent change from baseline at months 6 and 12 in BMD of the femoral neck as the dependent variable, and baseline BMD, machine type, interaction of baseline BMD and machine type, visit (categorical), treatment (categorical), and interaction of treatment and visit as the independent variables; using an unstructured variance covariance structure.|||-0.6|0.2846
72378328|NCT01992159|144264757|SUPERIORITY||Treatment Difference|1.3||||0.0151|ONE_SIDED|95.0|0.3||||Repeated Measures Model|||The analysis was based on a repeated measures model with the percent change from baseline at months 6 and 12 in BMD of the femoral neck as the dependent variable, and baseline BMD, machine type, interaction of baseline BMD and machine type, visit (categorical), treatment (categorical), and interaction of treatment and visit as the independent variables; using an unstructured variance covariance structure.|||0.3|0.0151
72378329|NCT01992159|144264757|SUPERIORITY||Treatment Difference|2.6||||0.0001|ONE_SIDED|95.0|1.5||||Repeated Measures Model|||The analysis was based on a repeated measures model with the percent change from baseline at months 6 and 12 in BMD of the femoral neck as the dependent variable, and baseline BMD, machine type, interaction of baseline BMD and machine type, visit (categorical), treatment (categorical), and interaction of treatment and visit as the independent variables; using an unstructured variance covariance structure.|||1.5|0.0001
72378330|NCT01992159|144264758|SUPERIORITY||Treatment Difference|1.6||||0.0067|ONE_SIDED|95.0|0.5||||Repeated Measures Model|||The analysis was based on a repeated measures model with the percent change from baseline at months 6 and 12 in BMD of the femoral neck as the dependent variable, and baseline BMD, machine type, interaction of baseline BMD and machine type, visit (categorical), treatment (categorical), and interaction of treatment and visit as the independent variables; using an unstructured variance covariance structure.|||0.5|0.0067
72556303|NCT00862563|144643978|SUPERIORITY_OR_OTHER||Difference between least squares means|-2.1|STANDARD_ERROR_OF_MEAN|1.1||0.06|TWO_SIDED|||||p\<0.05 considered to be significant|ANOVA|||Comparison of Week 10 means for mean drinks per day obtained for the placebo and zonisamide groups. Means used for the analysis are least means squares from a two-way repeated measures mixed models analysis, with Week (time) as the the within subject factor and treatment as the between group factor. Baseline values were used as covariates.||||0.06
72378331|NCT01992159|144264758|SUPERIORITY||Treatment Difference|2.6|||<|0.0001|ONE_SIDED|95.0|1.6||||Repeated Measures Model|||The analysis was based on a repeated measures model with the percent change from baseline at months 6 and 12 in BMD of the femoral neck as the dependent variable, and baseline BMD, machine type, interaction of baseline BMD and machine type, visit (categorical), treatment (categorical), and interaction of treatment and visit as the independent variables; using an unstructured variance covariance structure.|||1.6|< 0.0001
72556304|NCT00862563|144643978|SUPERIORITY_OR_OTHER||Difference between least squares means|-3.0|STANDARD_ERROR_OF_MEAN|1.1||0.008|TWO_SIDED|||||p\< 0.05 was considered to be significant.|ANOVA|||Comparison of Week 11 means for mean drinks per day obtained for the placebo and zonisamide groups. Means used for the analysis are least squares means from a two-way repeated measures mixed models analysis, with Week (time) as the the within subject factor and treatment as the between group factor. Baseline values were used as covariates.||||0.008
72378332|NCT01992159|144264758|SUPERIORITY||Treatment Difference|3.5|||<|0.0001|ONE_SIDED|95.0|2.3||||Repeated Measures Model|||The analysis was based on a repeated measures model with the percent change from baseline at months 6 and 12 in BMD of the femoral neck as the dependent variable, and baseline BMD, machine type, interaction of baseline BMD and machine type, visit (categorical), treatment (categorical), and interaction of treatment and visit as the independent variables; using an unstructured variance covariance structure.|||2.3|< 0.0001
72378333|NCT01992159|144264763|SUPERIORITY||Treatment Difference|-15.3||||0.5084|TWO_SIDED|95.0|-60.8|30.2|||ANCOVA|ANCOVA model with the AUC of P1NP at month 12 as the dependent variable, and baseline P1NP and treatment (categorical) as the independent variables.||||30.2|-60.8|0.5084
72378334|NCT01992159|144264763|SUPERIORITY||Treatment Difference|84.1||||0.0002|TWO_SIDED|95.0|40.1|128.0|||ANCOVA|ANCOVA model with the AUC of P1NP at month 12 as the dependent variable, and baseline P1NP and treatment (categorical) as the independent variables.||||128.0|40.1|0.0002
72378335|NCT01992159|144264763|SUPERIORITY||Treatment Difference|153.8|||<|0.0001|TWO_SIDED|95.0|109.2|198.4|||ANCOVA|ANCOVA model with the AUC of P1NP at months 12 as the dependent variable, and baseline P1NP and treatment (categorical) as the independent variables.||||198.4|109.2|< 0.0001
72378336|NCT01545843|144264769|SUPERIORITY_OR_OTHER_LEGACY|||||||0.202|TWO_SIDED||||||Mixed Models Analysis|||||||.202
72378337|NCT04243421|144264777|OTHER||Median Difference (Final Values)|6.0||||0.0007|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.0007
72378338|NCT04243421|144264778|OTHER||Median Difference (Final Values)|1.25||||0.0005|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.0005
72618495|NCT01026038|144768103|SUPERIORITY_OR_OTHER||GMC Ratio|1.15|||||TWO_SIDED|95.0|0.87|1.52||||||Serotype 4: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.52|0.87|
72378339|NCT04243421|144264778|OTHER||Median Difference (Final Values)|1.0||||0.0034|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.0034
72378340|NCT04243421|144264779|OTHER|||||||0.39|||||||Wilcoxon (Mann-Whitney)|||||||0.39
72378341|NCT01249118|144264785|SUPERIORITY_OR_OTHER||Ratio of LS Means|8.45|||||TWO_SIDED|90.0|7.08|10.08|||||The 90 percent (%) confidence intervals (CI) of test group (oral dose) means relative to reference group (IV dose) means were obtained by taking antilog of corresponding 90% CI for the differences between the means on the log scale.|Least squares (LS) mean was calculated from analysis of variance (ANOVA). Data for dose-normalized Cmax were natural log-transformed prior to analysis.||10.08|7.08|
72378342|NCT01249118|144264789|SUPERIORITY_OR_OTHER||Ratio of LS Means|48.6|||||TWO_SIDED|90.0|41.43|56.94|||||The 90% CI of the test group (oral dose) means relative to the reference group (IV dose) means were obtained by taking the antilog of the corresponding 90% CI for the differences between the means on the log scale.|LS means was calculated from ANOVA. Data for dose-normalized AUC (0 - t) were natural log-transformed prior to analysis.||56.94|41.43|
72433607|NCT00991276|144380370|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.45|STANDARD_ERROR_OF_MEAN|2.52||0.8589|TWO_SIDED|95.0|-5.44|4.54||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||4.54|-5.44|0.8589
72378343|NCT01249118|144264791|SUPERIORITY_OR_OTHER||Ratio of LS Means|45.9|||||TWO_SIDED|90.0|39.74|53.06|||||The 90% CI of the test group (oral dose) means relative to the reference group (IV dose) means were obtained by taking the antilog of the corresponding 90% CI for the differences between the means on the log scale.|LS mean was calculated from ANOVA. Data for dose-normalized AUC (0 - ∞) were natural log-transformed prior to analysis.||53.06|39.74|
72378344|NCT00095238|144264818|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2|||||TWO_SIDED|95.0|-0.8|1.3|||Mixed Models Analysis|baseline score used as covariate; treatment, visit, treatment-by-visit, \& baseline angiotensin-converting enzyme (ACE) inhibitors used as predictors||Comparison of 2 treatment arms at Month 6 (first 2 columns)||1.3|-0.8|
72378345|NCT00095238|144264818|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.6|||||TWO_SIDED|95.0|-0.5|1.7|||Mixed Models Analysis|baseline score used as covariate; treatment, visit, treatment-by-visit, \& baseline angiotensin-converting enzyme (ACE) inhibitors used as predictors||comparison of 2 treatment arms at Month 14 (columns 3 and 4)||1.7|-0.5|
72378346|NCT02524977|144264863|SUPERIORITY_OR_OTHER|||||||0.02|||||||Chi-squared|||||||0.02
72378347|NCT02106923|144264872|NON_INFERIORITY_OR_EQUIVALENCE|Model includes effects for sequence, subjects within sequences, period and treatment.|Adjusted geometric mean ratio (%)|102.98|STANDARD_ERROR_OF_MEAN|1.014|<|0.0001|TWO_SIDED|90.0|100.505|105.514|||ANOVA|P-value for ratio outside interval 80%-125%|Ratio calculated as Empa/ 1000 mg Met FDC (Fasted) divided by Empa/1000 mg Glumetza® (Fasted)|||105.514|100.505|<0.0001
72378348|NCT02106923|144264872|NON_INFERIORITY_OR_EQUIVALENCE|Model includes effects for sequence, subjects within sequences, period and treatment.|Adjusted geometric mean ratio (%)|100.25|STANDARD_ERROR_OF_MEAN|1.021|<|0.0001|TWO_SIDED|90.0|96.809|103.823|||ANOVA|P-value for ratio outside interval 80%-125%|Ratio calculated as Empa/ 1000 mg Met FDC (Fed) divided by Empa/1000 mg Glumetza ® (Fed)|||103.823|96.809|<0.0001
72378349|NCT02106923|144264872|NON_INFERIORITY_OR_EQUIVALENCE|Model includes effects for sequence, subjects within sequences, period and treatment.|Adjusted geometric mean ratio (%)|96.08|STANDARD_ERROR_OF_MEAN|1.016|<|0.0001|TWO_SIDED|90.0|93.507|98.721|||ANOVA|P-value for ratio outside interval 80%-125%|Ratio calculated as Empa/ 1500 mg Met FDC (Fasted) divided by Empa/ 1500 mg Glumetza® (Fasted)|||98.721|93.507|<0.0001
72378350|NCT02106923|144264873|NON_INFERIORITY_OR_EQUIVALENCE|Model includes effects for sequence, subjects within sequences, period and treatment.|Adjusted geometric mean ratio (%)|102.04|STANDARD_ERROR_OF_MEAN|1.06||0.0011|TWO_SIDED|90.0|92.3|112.81|||ANOVA|P-value for ratio outside interval 80%-125%|Ratio calculated as Empa/ 1000 mg Met FDC (Fasted) divided by Empa/1000 mg Glumetza® (Fasted)|||112.81|92.30|0.0011
72378351|NCT02106923|144264873|NON_INFERIORITY_OR_EQUIVALENCE|Model includes effects for sequence, subjects within sequences, period and treatment.|Adjusted geometric mean ratio (%)|98.93|STANDARD_ERROR_OF_MEAN|1.02|<|0.0001|TWO_SIDED|90.0|95.45|102.53|||ANOVA|P-value for ratio outside interval 80%-125%|Ratio calculated as Empa/ 1000 mg Met FDC (Fed) divided by Empa/1000 mg Glumetza ® (Fed)|||102.53|95.45|<0.0001
72378352|NCT02106923|144264873|NON_INFERIORITY_OR_EQUIVALENCE|Model includes effects for sequence, subjects within sequences, period and treatment.|Adjusted geometric mean ratio (%)|101.7|STANDARD_ERROR_OF_MEAN|1.05||0.0002|TWO_SIDED|90.0|93.59|110.52|||ANOVA|P-value for ratio outside interval 80%-125%|Ratio calculated as Empa/ 1500 mg Met FDC (Fasted) divided by Empa/ 1500 mg Glumetza® (Fasted)|||110.52|93.59|0.0002
72378353|NCT02106923|144264874|NON_INFERIORITY_OR_EQUIVALENCE|Model includes effects for sequence, subjects within sequences, period and treatment.|Adjusted geometric mean ratio (%)|102.88|STANDARD_ERROR_OF_MEAN|1.014|<|0.0001|TWO_SIDED|90.0|100.446|105.373|||ANOVA|P-value for ratio outside interval 80%-125%|Ratio calculated as Empa/ 1000 mg Met FDC (Fasted) divided by Empa/1000 mg Glumetza® (Fasted)|||105.373|100.446|<0.0001
72378354|NCT02106923|144264874|NON_INFERIORITY_OR_EQUIVALENCE|Model includes effects for sequence, subjects within sequences, period and treatment.|Adjusted geometric mean ratio (%)|100.03|STANDARD_ERROR_OF_MEAN|1.021|<|0.0001|TWO_SIDED|90.0|96.448|103.738|||ANOVA|P-value for ratio outside interval 80%-125%|Ratio calculated as Empa/ 1000 mg Met FDC (Fed) divided by Empa/1000 mg Glumetza ® (Fed)|||103.738|96.448|<0.0001
72378355|NCT02106923|144264874|NON_INFERIORITY_OR_EQUIVALENCE|Model includes effects for sequence, subjects within sequences, period and treatment.|Adjusted geometric mean ratio (%)|96.49|STANDARD_ERROR_OF_MEAN|1.017|<|0.0001|TWO_SIDED|90.0|93.758|99.311|||ANOVA|P-value for ratio outside interval 80%-125%|Ratio calculated as Empa/ 1500 mg Met FDC (Fasted) divided by Empa/ 1500 mg Glumetza® (Fasted)|||99.311|93.758|<0.0001
72378356|NCT02106923|144264875|NON_INFERIORITY_OR_EQUIVALENCE|Model includes effects for sequence, subjects within sequences, period and treatment.|Adjusted geometric mean ratio (%)|104.83|STANDARD_ERROR_OF_MEAN|1.031|<|0.0001|TWO_SIDED|90.0|99.522|110.412|||ANOVA|P-value for ratio outside interval 80%-125%|Ratio calculated as Empa/ 1000 mg Met FDC (Fasted) divided by Empa/1000 mg Glumetza® (Fasted)|||110.412|99.522|<0.0001
72378357|NCT02106923|144264875|NON_INFERIORITY_OR_EQUIVALENCE|Model includes effects for sequence, subjects within sequences, period and treatment.|Adjusted geometric mean ratio (%)|101.84|STANDARD_ERROR_OF_MEAN|1.041|<|0.0001|TWO_SIDED|90.0|95.03|109.134|||ANOVA|P-value for ratio outside interval 80%-125%|Ratio calculated as Empa/ 1000 mg Met FDC (Fed) divided by Empa/1000 mg Glumetza ® (Fed)|||109.134|95.030|<0.0001
72378358|NCT02106923|144264875|NON_INFERIORITY_OR_EQUIVALENCE|Model includes effects for sequence, subjects within sequences, period and treatment.|Adjusted geometric mean ratio (%)|96.03|STANDARD_ERROR_OF_MEAN|1.037|<|0.0001|TWO_SIDED|90.0|90.217|102.211|||ANOVA|P-value for ratio outside interval 80%-125%|Ratio calculated as Empa/ 1500 mg Met FDC (Fasted) divided by Empa/ 1500 mg Glumetza® (Fasted)|||102.211|90.217|<0.0001
72378359|NCT02106923|144264876|NON_INFERIORITY_OR_EQUIVALENCE|Model includes effects for sequence, subjects within sequences, period and treatment.|Adjusted geometric mean ratio (%)|98.94|STANDARD_DEVIATION|1.071||0.0027|TWO_SIDED|90.0|87.925|111.329|||ANOVA|P-value for ratio outside interval 80%-125%|Ratio calculated as Empa/ 1000 mg Met FDC (Fasted) divided by Empa/1000 mg Glumetza® (Fasted)|||111.329|87.925|0.0027
72378360|NCT02106923|144264876|NON_INFERIORITY_OR_EQUIVALENCE|Model includes effects for sequence, subjects within sequences, period and treatment.|Adjusted geometric mean ratio (%)|108.18|STANDARD_ERROR_OF_MEAN|1.03|<|0.0001|TWO_SIDED|90.0|102.792|113.859|||ANOVA|P-value for ratio outside interval 80%-125%|Ratio calculated as Empa/ 1000 mg Met FDC (Fed) divided by Empa/1000 mg Glumetza ® (Fed)|||113.859|102.792|<0.0001
72378361|NCT02106923|144264876|NON_INFERIORITY_OR_EQUIVALENCE|Model includes effects for sequence, subjects within sequences, period and treatment.|Adjusted geometric mean ratio (%)|103.62|STANDARD_ERROR_OF_MEAN|1.071||0.006|TWO_SIDED|90.0|92.116|116.559|||ANOVA|P-value for ratio outside interval 80%-125%|Ratio calculated as Empa/ 1500 mg Met FDC (Fasted) divided by Empa/ 1500 mg Glumetza® (Fasted)|||116.559|92.116|0.0060
72378362|NCT02106923|144264877|NON_INFERIORITY_OR_EQUIVALENCE|Model includes effects for sequence, subjects within sequences, period and treatment.|Adjusted geometric mean ratio (%)|98.33|STANDARD_ERROR_OF_MEAN|1.06||0.0008|TWO_SIDED|90.0|89.13|108.47|||ANOVA|P-value for ratio outside interval 80%-125%|Ratio calculated as Empa/ 1000 mg Met FDC (Fasted) divided by Empa/1000 mg Glumetza® (Fasted)|||108.47|89.13|0.0008
72378363|NCT02106923|144264877|NON_INFERIORITY_OR_EQUIVALENCE|Model includes effects for sequence, subjects within sequences, period and treatment.|Adjusted geometric mean ratio (%)|98.71|STANDARD_ERROR_OF_MEAN|1.02|<|0.0001|TWO_SIDED|90.0|94.77|102.8|||ANOVA|P-value for ratio outside interval 80%-125%|Ratio calculated as Empa/ 1000 mg Met FDC (Fed) divided by Empa/1000 mg Glumetza ® (Fed)|||102.80|94.77|<0.0001
72618496|NCT01026038|144768103|SUPERIORITY_OR_OTHER||GMC Ratio|1.42|||||TWO_SIDED|95.0|1.03|1.96||||||Serotype 4: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.96|1.03|
72378364|NCT02106923|144264877|NON_INFERIORITY_OR_EQUIVALENCE|Model includes effects for sequence, subjects within sequences, period and treatment.|Adjusted geometric mean ratio (%)|103.9|STANDARD_ERROR_OF_MEAN|1.06||0.0021|TWO_SIDED|90.0|94.09|114.74|||ANOVA|P-value for ratio outside interval 80%-125%|Ratio calculated as Empa/ 1500 mg Met FDC (Fasted) divided by Empa/ 1500 mg Glumetza® (Fasted)|||114.74|94.09|0.0021
72378365|NCT03485495|144264878|SUPERIORITY|||||||0.007||||||A priori threshold for statistical significance is split evenly between primary and secondary endpoints. α=0.025.|t-test, 2 sided|||This analysis applies to ∆ between baseline and after 12 weeks row.||||0.007
72378366|NCT03485495|144264879|SUPERIORITY|||||||0.0272||||||A priori threshold for statistical significance is split evenly between primary and secondary endpoints. α=0.025.|Fisher Exact|||||||0.0272
72378367|NCT03485495|144264880|SUPERIORITY|||||||0.8762|||||||t-test, 2 sided|||This analysis applies to ∆ between baseline and after 12 weeks row.||||0.8762
72378368|NCT03485495|144264881|SUPERIORITY|||||||0.2082|||||||Wilcoxon (Mann-Whitney)|||This analysis applies to ∆ between baseline and after 12 weeks row.||||0.2082
72378369|NCT03485495|144264882|SUPERIORITY|||||||0.0038||||||"The p-value associated with treatment\*visit interaction between Divaza and Placebo treatment groups. Model includes cuff test status, treatment, visit and treatment\*visit interaction."|Mixed Models Analysis|||This analysis applies to NO-3 data.||||0.0038
72378370|NCT03485495|144264882|SUPERIORITY|||||||0.0018||||||"The p-value associated with treatment\*visit interaction between Divaza and Placebo treatment groups. Model includes cuff test status, treatment, visit and treatment\*visit interaction."|Mixed Models Analysis|||This analysis applies to NO-2 data.||||0.0018
72378371|NCT03485495|144264882|SUPERIORITY|||||||0.46||||||"The p-value associated with treatment\*visit interaction between Divaza and Placebo treatment groups. Model includes cuff test status, treatment, visit and treatment\*visit interaction."|Mixed Models Analysis|||This analysis applies to NO data.||||0.46
72378372|NCT03485495|144264883|SUPERIORITY|||||||0.88||||||"The p-value associated with treatment\*visit interaction between Divaza and Placebo treatment groups. Model includes cuff test status, treatment, visit and treatment\*visit interaction."|Mixed Models Analysis|||This analysis applies to ADP-PA data.||||0.88
72378373|NCT03485495|144264883|SUPERIORITY|||||||0.93||||||"The p-value associated with treatment\*visit interaction between Divaza and Placebo treatment groups. Model includes cuff test status, treatment, visit and treatment\*visit interaction."|Mixed Models Analysis|||This analysis applies to ADR-PA data.||||0.93
72378374|NCT00773838|144264905|OTHER|||||||0.419|||||||Exact Test for Binomial Parameter|||||||0.419
72378375|NCT02502006|144264919|SUPERIORITY||||||<|0.0001|||||||ANOVA|||||||<0.0001
72378376|NCT02502006|144264920|SUPERIORITY|||||||0.0004|||||||ANOVA|||||||0.0004
72378377|NCT02502006|144264921|SUPERIORITY||||||<|0.0001|||||||ANOVA|||||||<0.0001
72378378|NCT02502006|144264922|SUPERIORITY|||||||0.2217|||||||ANOVA|||||||0.2217
72378379|NCT02502006|144264923|SUPERIORITY|||||||0.77||||||Adjusted for multiple comparisons|ANOVA|||||||0.77
72378380|NCT02502006|144264923|SUPERIORITY|||||||0.18||||||Adjusted for multiple comparisons|ANOVA|||||||0.18
72378381|NCT02502006|144264924|SUPERIORITY|||||||0.57||||||Adjusted for multiple comparisons|ANOVA|||||||0.57
72378382|NCT02502006|144264924|SUPERIORITY|||||||0.07||||||Adjusted for multiple comparisons|ANOVA|||||||0.07
72378383|NCT02502006|144264925|SUPERIORITY|||||||0.88||||||Adjusted for multiple comparisons|ANOVA|||||||0.88
72556305|NCT00862563|144643978|SUPERIORITY_OR_OTHER||Difference between least squares means|-2.1|STANDARD_ERROR_OF_MEAN|1.2||0.07|TWO_SIDED|||||p\< 0.05 was considered to be significant.|Mixed Models Analysis|||Comparison of Week 12 mean for mean drinks per day obtained for the placebo and zonisamide groups. Means used for the analysis are least squares means from a two-way repeated measures mixed models analysis, with Week (time) as the the within subject factor and treatment as the between group factor. Baseline values were used as covariates.||||0.07
72378384|NCT02502006|144264925|SUPERIORITY||||||<|0.05||||||Adjusted for multiple comparisons|ANOVA|||||||<0.05
72378385|NCT00997113|144264942|SUPERIORITY_OR_OTHER|||||||0.94|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Comparison of the change in serum catecholamines from one minute before the procedure to one minute after. In order to detect a 20% difference in mean catecholamine values between groups, assuming a 30% standard deviation, with an alpha of 0.05 and a beta of 0.2 (80% power), power analysis indicated that 10 patients per group were required.||||0.940
72378386|NCT02674854|144264952|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|PG324 vs. netarsudil||||||<0.0001
72378387|NCT02674854|144264952|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|PG324 vs. latanoprost||||||<0.0001
72378388|NCT02889562|144264958|OTHER|Pearson chi-squared tests or Fisher exact tests||||||1|||||||Chi-squared|||||||1.0
72378389|NCT02889562|144264961|OTHER|t-test and Wilcoxon analysis||||||0.17|||||||t-test, 1 sided|||||||0.17
72378390|NCT01943474|144264963|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Fisher Exact|||||||<0.0001
72378391|NCT01943474|144264964|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Fisher Exact|||||||<0.0001
72378392|NCT01943474|144264965|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Fisher Exact|||||||<0.0001
72378393|NCT01943474|144264966|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||t-test, 2 sided|||||||<0.0001
72378394|NCT01943474|144264967|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||t-test, 2 sided|||||||<0.0001
72378395|NCT01943474|144264970|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||t-test, 2 sided|||||||<0.0001
72378396|NCT01943474|144264971|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||t-test, 2 sided|||||||<0.0001
72378397|NCT02119676|144264981|OTHER||Hazard Ratio (HR)|1.04||||0.588|TWO_SIDED|95.0|0.73|1.49||1-sided|Log Rank|Log-rank test stratified by modified Glasgow Prognostic Score (mGPS) and geographical region.|Estimated using a Cox regression model with Efron's method used for ties, stratified by mGPS score and geographical region|||1.49|0.73|0.588
72378398|NCT02119676|144264981|OTHER||Hazard Ratio (HR)|0.77||||0.136|TWO_SIDED|95.0|0.48|1.23||1-sided|Log Rank|Log rank test stratified by geographical region.|Estimated using Cox regression model with Efron's method used for ties, stratified by geographical region|||1.23|0.48|0.136
72378399|NCT02216812|144264987|OTHER|||||||0.63|||||||Regression, Linear|||We tested the null hypothesis that there is no difference in DPC six weeks after fracture of the distal radius between patients taking vitamin C and placebo.||||0.63
72378400|NCT00266864|144264992|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.4|STANDARD_DEVIATION|2.7|<|0.01|TWO_SIDED|95.0||||One sample t -tests were performed on the percent change from baseline to month 12 \[(month 12- baseline)/baseline\*100\] for comparison to the null hypothesis. An a priori level of significance was set at p ≤ 0.05.|ANOVA|||Separate 2 factor (group: treatment, control) analysis of variance (ANOVA) with repeated measures on visit (baseline, month 12) were performed to identify changes in lean tissue mass across time. To further characterize significant main and interaction effects, post-hoc paired t -tests were performed within group.||||<0.01
72378401|NCT00266864|144264993|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|101.0|STANDARD_DEVIATION|103.0||0.051|TWO_SIDED|95.0||||One sample t -tests were performed on the percent change from baseline to month 12 \[(month 12- baseline)/baseline\*100\] for comparison to the null hypothesis. An a priori level of significance was set at p ≤ 0.05.|ANOVA|||Separate 2 factor (group: treatment, control) analysis of variance (ANOVA) with repeated measures on visit (baseline, month 12) were performed to identify changes in resting energy expenditure across time. To further characterize significant main and interaction effects, post-hoc paired t -tests were performed within group.||||0.051
72378402|NCT01077154|144264994|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.7|TWO_SIDED|95.0|0.82|1.14|||Stratified Log Rank|Stratified by breast cancer therapy/LN status, hormone receptor status, HER-2 status, age, and geographic region.|Based on a Cox proportional hazards model stratified by the randomization stratification factors; a hazard ratio \< 1 favors denosumab.|||1.14|0.82|0.70
72378403|NCT01077154|144264995|SUPERIORITY||Hazard Ratio (HR)|1.04||||0.57|TWO_SIDED|95.0|0.91|1.19|||Stratified Log Rank|Stratified by breast cancer therapy/LN status, hormone receptor status, HER-2 status, age, and geographic region.|Based on a Cox proportional hazards model stratified by the randomization stratification factors; a hzard ratio \< 1 favors denosumab.|||1.19|0.91|0.57
72378404|NCT01077154|144264996|SUPERIORITY||Hazard Ratio (HR)|1.12||||0.26|TWO_SIDED|95.0|0.92|1.36|||Stratified Log Rank|Stratified by breast cancer therapy/LN status, hormone receptor status, HER-2 status, age, and geographic region.|Based on a Cox proportional hazards model stratified by the randomization stratification factors; a hazard ratio \< 1 favors denosumab.|||1.36|0.92|0.26
72378405|NCT01077154|144264997|SUPERIORITY||Hazard Ratio (HR)|1.01||||0.94|TWO_SIDED|95.0|0.83|1.22|||Stratified Log Rank|Stratified by breast cancer therapy/LN status, hormone receptor status, HER-2 status, age, and geographic region.|Based on a Cox proportional hazards model stratified by the randomization stratification factors; a hazard ratio \< 1 favors denosumab.|||1.22|0.83|0.94
72378406|NCT01077154|144264998|SUPERIORITY||Hazard Ratio (HR)|1.06||||0.41|TWO_SIDED|95.0|0.92|1.21|||Stratified Log Rank|Stratified by breast cancer therapy/LN status, hormone receptor status, HER-2 status, age, and geographic region.|Based on a Cox proportional hazards model stratified by the randomization stratification factors; a hazard ratio \< 1 favors denosumab.|||1.21|0.92|0.41
72378407|NCT03050775|144265006|SUPERIORITY|||||||0.807|||||||t-test, 2 sided|||||||0.807
72378408|NCT03050775|144265006|SUPERIORITY||Mean Difference (Final Values)|0.076||||0.358|TWO_SIDED|95.0|-0.085|0.237|||ANCOVA|||||0.237|-0.085|0.358
72378409|NCT03050775|144265007|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.823|TWO_SIDED|95.0|-0.3|0.2|||t-test, 2 sided|||\~30 minutes post-induction||0.2|-0.3|0.823
72378410|NCT03050775|144265007|SUPERIORITY||Median Difference (Final Values)|0.0||||0.853|TWO_SIDED|95.0|-0.2|0.3|||t-test, 2 sided|||\~60 minutes post-induction. Data was obtained from 33 subjects in the treatment group.||0.3|-0.2|0.853
72378411|NCT03050775|144265007|SUPERIORITY||Median Difference (Final Values)|0.0||||0.986|TWO_SIDED|95.0|-0.2|0.2|||t-test, 2 sided|||\~120 minutes post-induction||0.2|-0.2|0.986
72378412|NCT03050775|144265008|SUPERIORITY||Odds Ratio (OR)|1.7||||0.54|TWO_SIDED|95.0|0.5|5.9|||Fisher Exact|||Post-operative shivering observed||5.9|0.5|0.540
72378413|NCT03050775|144265009|SUPERIORITY||Median Difference (Final Values)|0.0||||0.672|TWO_SIDED|95.0|-1.0|1.0|||Wilcoxon (Mann-Whitney)|||||1|-1|0.672
72378414|NCT03050775|144265010|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.571|TWO_SIDED|95.0|-0.2|0.1|||t-test, 2 sided|||Data was obtained from 32 subjects in the treatment group.||0.1|-0.2|0.571
72378415|NCT03050775|144265011|SUPERIORITY||Odds Ratio (OR)|1.4||||0.619|TWO_SIDED|95.0|0.5|3.7|||Fisher Exact|||||3.7|0.5|0.619
72378416|NCT03050775|144265012|SUPERIORITY||Median Difference (Final Values)|75.0||||0.404|TWO_SIDED|95.0|-100.0|250.0|||Wilcoxon (Mann-Whitney)|||||250|-100|0.404
72378417|NCT03274999|144265016|SUPERIORITY|||||||0.156||||||Eye-opening, T0: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T0) between the intranasal (test) and extranasal (control) applications are zero.||||0.156
72378418|NCT03274999|144265016|SUPERIORITY|||||||0.395||||||Eye-opening, T15: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T15) between the intranasal (test) and extranasal (control) applications are zero.||||0.395
72378419|NCT03274999|144265016|SUPERIORITY|||||||0.114||||||Eye-opening, T30: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T30) between the intranasal (test) and extranasal (control) applications are zero.||||0.114
72378420|NCT03274999|144265016|SUPERIORITY|||||||0.211||||||Eye-opening, T60: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T60) between the intranasal (test) and extranasal (control) applications are zero.||||0.211
72378421|NCT03274999|144265016|SUPERIORITY|||||||0.332||||||Eye-opening, T120: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T120) between the intranasal (test) and extranasal (control) applications are zero.||||0.332
72378422|NCT03274999|144265016|SUPERIORITY|||||||0.318||||||Eye-opening, T180: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T180) between the intranasal (test) and extranasal (control) applications are zero.||||0.318
72378423|NCT03274999|144265016|SUPERIORITY|||||||0.375||||||Eye-opening, T240: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T240) between the intranasal (test) and extranasal (control) applications are zero.||||0.375
72378424|NCT03274999|144265016|SUPERIORITY|||||||0.352||||||Eye-opening, T300: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T300) between the intranasal (test) and extranasal (control) applications are zero.||||0.352
72378425|NCT03274999|144265016|SUPERIORITY|||||||0.312||||||Eye-opening, T360: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T360) between the intranasal (test) and extranasal (control) applications are zero.||||0.312
72378426|NCT03274999|144265016|SUPERIORITY|||||||0.134||||||Pre-blink, T0: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T0) between the intranasal (test) and extranasal (control) applications are zero.||||0.134
72378427|NCT03274999|144265016|SUPERIORITY|||||||0.315||||||Pre-blink, T15: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T15) between the intranasal (test) and extranasal (control) applications are zero.||||0.315
72618497|NCT01026038|144768103|SUPERIORITY_OR_OTHER||GMC ratio|0.62|||||TWO_SIDED|95.0|0.46|0.84||||||Serotype 6B: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||0.84|0.46|
72378428|NCT03274999|144265016|SUPERIORITY|||||||0.071||||||Pre-blink, T30: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T30) between the intranasal (test) and extranasal (control) applications are zero.||||0.071
72378429|NCT03274999|144265016|SUPERIORITY|||||||0.26||||||Pre-blink, T60: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T60) between the intranasal (test) and extranasal (control) applications are zero.||||0.260
72378430|NCT03274999|144265016|SUPERIORITY|||||||0.264||||||Pre-blink, T120: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T120) between the intranasal (test) and extranasal (control) applications are zero.||||0.264
72378431|NCT03274999|144265016|SUPERIORITY|||||||0.381||||||Pre-blink, T180: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T180) between the intranasal (test) and extranasal (control) applications are zero.||||0.381
72378432|NCT03274999|144265016|SUPERIORITY|||||||0.249||||||Pre-blink, T240: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T240) between the intranasal (test) and extranasal (control) applications are zero.||||0.249
72378433|NCT03274999|144265016|SUPERIORITY|||||||0.451||||||Pre-blink, T300: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T300) between the intranasal (test) and extranasal (control) applications are zero.||||0.451
72378434|NCT03274999|144265016|SUPERIORITY|||||||0.393||||||Pre-blink, T360: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T360) between the intranasal (test) and extranasal (control) applications are zero.||||0.393
72378435|NCT03274999|144265017|SUPERIORITY|||||||0.006||||||Eye-opening, T0: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T0) between the intranasal (test) and extranasal (control) applications are zero.||||0.006
72378436|NCT03274999|144265017|SUPERIORITY|||||||0.063||||||Eye-opening, T15: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T15) between the intranasal (test) and extranasal (control) applications are zero.||||0.063
72378437|NCT03274999|144265017|SUPERIORITY|||||||0.005||||||Eye-opening, T30: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T30) between the intranasal (test) and extranasal (control) applications are zero.||||0.005
72378438|NCT03274999|144265017|SUPERIORITY|||||||0.089||||||Eye-opening, T60: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T60) between the intranasal (test) and extranasal (control) applications are zero.||||0.089
72378439|NCT03274999|144265017|SUPERIORITY|||||||0.112||||||Eye-opening, T120: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T120) between the intranasal (test) and extranasal (control) applications are zero.||||0.112
72378440|NCT03274999|144265017|SUPERIORITY|||||||0.16||||||Eye-opening, T180: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T180) between the intranasal (test) and extranasal (control) applications are zero.||||0.16
72378441|NCT03274999|144265017|SUPERIORITY|||||||0.077||||||Eye-opening, T240: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T240) between the intranasal (test) and extranasal (control) applications are zero.||||0.077
72378442|NCT03274999|144265017|SUPERIORITY|||||||0.157||||||Eye-opening, T300: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T300) between the intranasal (test) and extranasal (control) applications are zero.||||0.157
72378443|NCT03274999|144265017|SUPERIORITY|||||||0.111||||||Eye-opening, T360: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T360) between the intranasal (test) and extranasal (control) applications are zero.||||0.111
72378444|NCT03274999|144265017|SUPERIORITY|||||||0.04||||||Pre-blink, T0: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T0) between the intranasal (test) and extranasal (control) applications are zero.||||0.040
72378445|NCT03274999|144265017|SUPERIORITY|||||||0.241||||||Pre-blink, T15: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T15) between the intranasal (test) and extranasal (control) applications are zero.||||0.241
72378446|NCT03274999|144265017|SUPERIORITY|||||||0.284||||||Pre-blink, T30: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T30) between the intranasal (test) and extranasal (control) applications are zero.||||0.284
72378447|NCT03274999|144265017|SUPERIORITY|||||||0.313||||||Pre-blink, T60: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T60) between the intranasal (test) and extranasal (control) applications are zero.||||0.313
72378448|NCT03274999|144265017|SUPERIORITY|||||||0.433||||||Pre-blink, T120: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T120) between the intranasal (test) and extranasal (control) applications are zero.||||0.433
72378449|NCT03274999|144265017|SUPERIORITY|||||||0.406||||||Pre-blink, T180: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T180) between the intranasal (test) and extranasal (control) applications are zero.||||0.406
72378450|NCT03274999|144265017|SUPERIORITY|||||||0.318||||||Pre-blink, T240: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T240) between the intranasal (test) and extranasal (control) applications are zero.||||0.318
72378451|NCT03274999|144265017|SUPERIORITY|||||||0.499||||||Pre-blink, T300: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T300) between the intranasal (test) and extranasal (control) applications are zero.||||0.499
72378452|NCT03274999|144265017|SUPERIORITY|||||||0.39||||||Pre-blink, T360: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T360) between the intranasal (test) and extranasal (control) applications are zero.||||0.390
72378453|NCT03274999|144265018|SUPERIORITY|||||||0.053||||||T0: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T0) between the intranasal (test) and extranasal (control) applications are zero.||||0.053
72378454|NCT03274999|144265018|SUPERIORITY|||||||0.206||||||T15: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T15) between the intranasal (test) and extranasal (control) applications are zero.||||0.206
72378455|NCT03274999|144265018|SUPERIORITY|||||||0.221||||||T30: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T30) between the intranasal (test) and extranasal (control) applications are zero.||||0.221
72556306|NCT00862563|144643978|SUPERIORITY_OR_OTHER||Difference between least squares means.|-3.4|STANDARD_ERROR_OF_MEAN|1.1||0.003|TWO_SIDED|||||p\<0.05 is considered as being significant.|ANOVA|||Comparison of Week 10 mean for mean drinks per day obtained for the placebo and topiramate groups. Means used for the analysis are least squares means from a two-way repeated measures mixed models analysis, with Week (time) as the the within subject factor and treatment as the between group factor. Baseline values were used as covariates,||||0.003
72378456|NCT03274999|144265018|SUPERIORITY|||||||0.126||||||T60: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T60) between the intranasal (test) and extranasal (control) applications are zero.||||0.126
72378457|NCT03274999|144265018|SUPERIORITY|||||||0.124||||||T120: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T120) between the intranasal (test) and extranasal (control) applications are zero.||||0.124
72378458|NCT03274999|144265018|SUPERIORITY|||||||0.167||||||T180: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T180) between the intranasal (test) and extranasal (control) applications are zero.||||0.167
72378459|NCT03274999|144265018|SUPERIORITY|||||||0.377||||||T240: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T240) between the intranasal (test) and extranasal (control) applications are zero.||||0.377
72378460|NCT03274999|144265018|SUPERIORITY|||||||0.397||||||T300: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T300) between the intranasal (test) and extranasal (control) applications are zero.||||0.397
72378461|NCT03274999|144265018|SUPERIORITY|||||||0.441||||||T360: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T360) between the intranasal (test) and extranasal (control) applications are zero.||||0.441
72378462|NCT03274999|144265019|SUPERIORITY|||||||0.034||||||T0: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T0) between the intranasal (test) and extranasal (control) applications are zero.||||0.034
72618498|NCT01026038|144768103|SUPERIORITY_OR_OTHER||GMC ratio|0.89|||||TWO_SIDED|95.0|0.66|1.2||||||Serotype 6B: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.20|0.66|
72378463|NCT03274999|144265019|SUPERIORITY|||||||0.143||||||T15: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T15) between the intranasal (test) and extranasal (control) applications are zero.||||0.143
72378464|NCT03274999|144265019|SUPERIORITY|||||||0.328||||||T30: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T30) between the intranasal (test) and extranasal (control) applications are zero.||||0.328
72378465|NCT03274999|144265019|SUPERIORITY|||||||0.25||||||T60: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T60) between the intranasal (test) and extranasal (control) applications are zero.||||0.250
72378466|NCT03274999|144265019|SUPERIORITY|||||||0.09||||||T120: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T120) between the intranasal (test) and extranasal (control) applications are zero.||||0.090
72378467|NCT03274999|144265019|SUPERIORITY|||||||0.328||||||T180: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T180) between the intranasal (test) and extranasal (control) applications are zero.||||0.328
72378468|NCT03274999|144265019|SUPERIORITY|||||||0.055||||||T240: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T240) between the intranasal (test) and extranasal (control) applications are zero.||||0.055
72378469|NCT03274999|144265019|SUPERIORITY|||||||0.09||||||T300: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T300) between the intranasal (test) and extranasal (control) applications are zero.||||0.090
72378470|NCT03274999|144265019|SUPERIORITY|||||||0.233||||||T360: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T360) between the intranasal (test) and extranasal (control) applications are zero.||||0.233
72378471|NCT03274999|144265020|SUPERIORITY|||||||0.072||||||T0: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T0) between the intranasal (test) and extranasal (control) applications are zero.||||0.072
72378472|NCT03274999|144265020|SUPERIORITY|||||||0.297||||||T15: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T15) between the intranasal (test) and extranasal (control) applications are zero.||||0.297
72378473|NCT03274999|144265020|SUPERIORITY|||||||0.328||||||T30: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T30) between the intranasal (test) and extranasal (control) applications are zero.||||0.328
72378474|NCT03274999|144265020|SUPERIORITY|||||||0.447||||||T60: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T60) between the intranasal (test) and extranasal (control) applications are zero.||||0.447
72378475|NCT03274999|144265020|SUPERIORITY|||||||0.328||||||T120: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T120) between the intranasal (test) and extranasal (control) applications are zero.||||0.328
72378476|NCT03274999|144265020|SUPERIORITY|||||||0.09||||||T180: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T180) between the intranasal (test) and extranasal (control) applications are zero.||||0.090
72378477|NCT03274999|144265020|SUPERIORITY|||||||0.055||||||T240: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T240) between the intranasal (test) and extranasal (control) applications are zero.||||0.055
72378478|NCT03274999|144265020|SUPERIORITY|||||||0.09||||||T300: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T300) between the intranasal (test) and extranasal (control) applications are zero.||||0.090
72378479|NCT03274999|144265020|SUPERIORITY|||||||0.5||||||T360: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T360) between the intranasal (test) and extranasal (control) applications are zero.||||0.500
72378480|NCT01206387|144265035|SUPERIORITY_OR_OTHER|||||||0.0003|||||||t-test, 2 sided|||||||0.0003
72378481|NCT01206387|144265036|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
72378482|NCT01206387|144265037|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
72378483|NCT01206387|144265038|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
72378484|NCT01206387|144265039|SUPERIORITY_OR_OTHER|||||||0.0011|||||||t-test, 2 sided|||||||0.0011
72378485|NCT00706849|144265040|SUPERIORITY_OR_OTHER||||||<|0.001||||||Statistical significance was concluded if p ≤ 0.05.|t-test, 2 sided|||Based upon prior clinical study experience with mipomersen, it was estimated that the standard deviation of the percent change in LDL-C is approximately 22%. With 20 patients in the control group and 40 patients in the mipomersen-treated group, this study would have at least 90% power to detect a 20% difference between the 2 treatment groups.||||<0.001
72378486|NCT00706849|144265042|SUPERIORITY_OR_OTHER||||||<|0.001||||||Inflation of type 1 error was controlled by specifying a small number of secondary parameters and a sequential inferential approach in which inferential conclusions about each successive parameter required statistical significance of the prior one.|t-test, 2 sided|||||||<0.001
72378487|NCT00706849|144265044|SUPERIORITY_OR_OTHER||||||<|0.001||||||Inflation of type 1 error was controlled by specifying a small number of secondary parameters and a sequential inferential approach in which inferential conclusions about each successive parameter required statistical significance of the prior one.|t-test, 2 sided|||||||<0.001
72378488|NCT00706849|144265046|SUPERIORITY_OR_OTHER||||||<|0.001||||||Inflation of type 1 error was controlled by specifying a small number of secondary parameters and a sequential inferential approach in which inferential conclusions about each successive parameter required statistical significance of the prior one.|t-test, 2 sided|||||||<0.001
72618499|NCT01026038|144768103|SUPERIORITY_OR_OTHER||GMC ratio|1.44|||||TWO_SIDED|95.0|1.02|2.04||||||Serotype 6B: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||2.04|1.02|
72378489|NCT00706849|144265048|SUPERIORITY_OR_OTHER|||||||0.042||||||No adjustments were made for tertiary parameters.|Wilcoxon (Mann-Whitney)|||||||0.042
72378490|NCT00706849|144265050|SUPERIORITY_OR_OTHER||||||<|0.001||||||No adjustments were made for tertiary parameters.|Wilcoxon (Mann-Whitney)|||||||<0.001
72378491|NCT00706849|144265052|SUPERIORITY_OR_OTHER|||||||0.023||||||No adjustments were made for tertiary parameters.|Wilcoxon (Mann-Whitney)|||||||0.023
72378492|NCT00706849|144265054|SUPERIORITY_OR_OTHER||||||<|0.001||||||No adjustments were made for tertiary parameters.|Wilcoxon (Mann-Whitney)|||||||<0.001
72378493|NCT00706849|144265056|SUPERIORITY_OR_OTHER|||||||0.004||||||No adjustments were made for tertiary parameters.|t-test, 2 sided|||||||0.004
72378494|NCT00706849|144265058|SUPERIORITY_OR_OTHER|||||||0.207||||||No adjustments were made for tertiary parameters.|Wilcoxon (Mann-Whitney)|||||||0.207
72378495|NCT00920907|144265073|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric mean|1.01|||||TWO_SIDED|90.0|0.916|1.114|||Least squared linear regression|||Biocomparability of ipilimumab Process C to ipilimumab Process B was concluded if the 90% confidence intervals (CIs) for the ratio of geometric means for Cmax were contained within 80% to 125%.||1.114|0.916|
72378496|NCT00920907|144265077|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric mean|1.032|||||TWO_SIDED|90.0|0.922|1.156|||Least squared linear regression|||Biocomparability of ipilimumab Process C to ipilimumab Process B was to be concluded if the 90% confidence intervals (CIs) for the ratio of geometric means for ipilimumab Cmax were contained within 80% to 125%. Point estimates and 90% CIs were constructed for the ratio of geometric means (Process C/Process B) for ipilimumab Cmax.||1.156|0.922|
72378497|NCT00920907|144265082|SUPERIORITY_OR_OTHER||omnibus conditional F-test|0.4||||0.85||||||Not corrected for multiple testing|F-test|numerator 5 degrees freedom, denominator 782 degrees freedom||Time-by-process interaction. Null hypothesis that the pattern of mean ALC values over time is the same for both processes.||||0.85
72378498|NCT00920907|144265082|SUPERIORITY_OR_OTHER||F-statistic|4.35|||<|0.0001|||||||F-test|numerator 10 degrees freedom, denominator 782 degrees freedom||Overall time effect. Null hypothesis of no mean ALC changes over time in either process group (treatment arm).||||<0.0001
72378499|NCT02616601|144265090|EQUIVALENCE|If the 90% confidence interval on the percentage difference between generic fluorouracil cream and Carac (fluorouracil) cream lesion clearance were contained within the interval -0.20 to +0.20, and each of these percentages was greater than and statistically different (p\<0.05) from the vehicle cream percentage, then generic fluorouracil cream and Carac (fluorouracil) cream were considered to be therapeutically equivalent.|Mean Difference (Net)|0.04|||||TWO_SIDED|90.0|-11.03|11.11|||||90% Wald's confidence interval with a continuity correction for the difference (Generic Fluorouracil Cream - Carac \[Fluorouracil\] Cream) in complete clearance rates.|||11.11|-11.03|
72378500|NCT02616601|144265090|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||||||<0.0001
72378501|NCT02616601|144265090|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||||||<0.0001
72378502|NCT02186301|144265091|OTHER||Kaplan-Meier Median|274.0|||||TWO_SIDED|95.0|109.0||Upper Confidence Limit is not available because it cannot be calculated||||||||109|
72378503|NCT02186301|144265091|OTHER||Kaplan-Meier Median|207.0|||||TWO_SIDED|95.0|112.0|260.0||||||||260.0|112.0|
72378504|NCT02186301|144265091|OTHER||Kaplan Meier Median|390.0|||||TWO_SIDED|95.0|282.0|499.0||||||||499.0|282.0|
72378505|NCT02186301|144265092|OTHER||Percentage|25.0|||||TWO_SIDED|95.0|8.7|49.1||||||||49.1|8.7|
72378506|NCT02186301|144265092|OTHER||Percentage|40.0|||||TWO_SIDED|95.0|22.7|59.4||||||||59.4|22.7|
72378507|NCT02186301|144265092|OTHER||Percentage|78.0|||||TWO_SIDED|95.0|64.0|88.5||||||||88.5|64.0|
72378508|NCT02186301|144265093|OTHER||Kaplan Meier Median|225.0|||||TWO_SIDED|95.0|113.0||Upper Confidence Limit is not available because it cannot be calculated.||||||||113|
72378509|NCT02186301|144265093|OTHER||Kaplan Meier Median|195.5|||||TWO_SIDED|95.0|143.0|617.0||||||||617.0|143.0|
72378510|NCT02186301|144265093|OTHER||Kaplan Meier Median|335.0|||||TWO_SIDED|95.0|282.0|480.0||||||||480.0|282.0|
72378511|NCT03560739|144265097|EQUIVALENCE|For reference-scaled average bioequivalence testing, both criteria have to be met: 1) geo-mean ratio needs to fall in \[0.8, 1.25\]; 2) 95% upper bound of the linearized criterion needs to be \<= 0. This part is regarding criterion 1.|Geo-mean ratio|1.03|||||TWO_SIDED|90.0|0.8|1.25|||||The confidence interval reported in the Point Estimate section below is the one from the criterion, not the estimated confidence interval.|Criteria 1 for bioequivalence testing of AUCtau||1.25|.8|
72378512|NCT03560739|144265097|EQUIVALENCE|For reference-scaled average bioequivalence testing, both criteria have to be met: 1) geo-mean ratio needs to fall in \[0.8, 1.25\]; 2) 95% upper bound of the linearized criterion needs to be \<= 0. This part is regarding criterion 2.|95% upper bound of the linearized criter|-0.3131|||||ONE_SIDED|95.0||0.0|||||The upper limit reported in the Point Estimate section below is the limit on the 95% upper bound from the criterion, not the estimated upper limit of the 95% upper bound of the linearized criterion|Criteria 2 for bioequivalence testing of AUCtau||0||
72378513|NCT03560739|144265098|EQUIVALENCE|For reference-scaled average bioequivalence testing, both criteria have to be met: 1) geo-mean ratio needs to fall in \[0.8, 1.25\]; 2) 95% upper bound of the linearized criterion needs to be \<= 0. This part is regarding criterion 1.|geo-mean ratio|1.0|||||TWO_SIDED|90.0|0.8|1.25|||||The confidence interval reported in the Point Estimate section below is the one from the criterion, not the estimated confidence interval.|Criteria 1 for bioequivalence testing of Cmax||1.25|.8|
72378514|NCT03560739|144265098|EQUIVALENCE|For reference-scaled average bioequivalence testing, both criteria have to be met: 1) geo-mean ratio needs to fall in \[0.8, 1.25\]; 2) 95% upper bound of the linearized criterion needs to be \<= 0. This part is regarding criterion 2.|95% upper bound of the linearized criter|-0.2446|||||ONE_SIDED|95.0||0.0|||||The upper limit reported in the Point Estimate section below is the limit on the 95% upper bound from the criterion, not the estimated upper limit of the 95% upper bound of the linearized criterion.|Criteria 2 for bioequivalence testing of Cmax||0||
72378515|NCT04389970|144265106|OTHER|Single group, within subject pre/post change.||||||0.39|||||||t-test, 2 sided|Paired-samples t-test||This was a feasibility study and was not powered to detect statistical significance. Significance values are presented but no conclusion of significance can be made.||||.39
72378516|NCT04389970|144265107|OTHER|Single group, within subject pre/post change.||||||0.3|||||||t-test, 2 sided|Paired-samples t-test||This was a feasibility study and was not powered to detect statistical significance. Significance values are presented but no evaluation of significance can be concluded.||||.3
72378517|NCT04389970|144265108|OTHER|Single group, within subjects pre/post change.||||||0.77|||||||t-test, 2 sided|Paired-sample t-test||This was a feasibility study and was not powered to detect statistical significance. Significance values are presented but no evaluation of significance can be concluded.||||.77
72378518|NCT04389970|144265109|OTHER|Single group, within subjects pre/post change.||||||0.66|||||||t-test, 2 sided|Paired-samples t-test.||This was a feasibility study and was not powered to detect statistical significance. Significance values are presented but no evaluation of significance can be concluded.||||.66
72378519|NCT04389970|144265110|OTHER|Single group, within subjects pre/post change||||||0.88|||||||t-test, 2 sided|Paired samples t-test||This was a feasibility study and was not powered to detect statistical significance. Significance values are presented but no evaluation of significance can be concluded.||||.88
72378520|NCT04389970|144265111|OTHER|Single group, within subjects pre/post change||||||0.03|||||||t-test, 2 sided|Paired-samples t-test||This was a feasibility study and was not powered to detect statistical significance. Significance values are presented but no evaluation of significance can be concluded.||||.03
72378521|NCT04389970|144265112|OTHER|Single group, within subjects pre/post change.||||||0.06|||||||t-test, 2 sided|Paired samples t-test||This was a feasibility study and was not powered to detect statistical significance. Significance values are presented but no evaluation of significance can be concluded.||||.06
72378522|NCT04389970|144265113|OTHER|Single group, within subjects pre/post change||||||0.04|||||||t-test, 2 sided|Paired samples t-test||This was a feasibility study and was not powered to detect statistical significance. Significance values are presented but no evaluation of significance can be concluded.||||.04
72378523|NCT04389970|144265114|OTHER|Single group, within subjects analysis.||||||0|||||||t-test, 2 sided|Paired sample t-test||This was a feasibility study and was not powered to detect statistical significance. Significance values are presented but no evaluation of significance can be concluded.||||0
72378524|NCT03123185|144265116|OTHER|No hypothesis was tested and no acceptance range was specified.|Geometric mean (gMean) ratio (%)|158.61|STANDARD_ERROR_OF_MEAN|22.4|||TWO_SIDED|90.0|133.679|188.195|||||gMean ratio = 10 mg BI 705564 fed/10 mg BI 705564 fast. Standard Error of the mean is actually the intra-individual geometric coefficient variation.|"The statistical model was an analysis of variance (ANOVA) on the logarithmic scale including effects for 'sequence', 'subjects nested within sequences', 'period' and 'treatment'. The effect subjects within sequences will be considered as random, the other effects as fixed."||188.195|133.679|
72378525|NCT03123185|144265117|OTHER|No hypothesis was tested and no acceptance range was specified.|gMean ratio (%)|194.18|STANDARD_ERROR_OF_MEAN|26.4|||TWO_SIDED|90.0|158.912|237.267|||||gMean ratio = 10 mg BI 705564 fed/10 mg BI 705564 fast. Standard Error of the mean is actually the intra-individual geometric coefficient variation.|"The statistical model was an analysis of variance (ANOVA) on the logarithmic scale including effects for 'sequence', 'subjects nested within sequences', 'period' and 'treatment'. The effect subjects within sequences will be considered as random, the other effects as fixed."||237.267|158.912|
72378526|NCT03123185|144265118|OTHER||Slope|0.4879|STANDARD_ERROR_OF_MEAN|0.0546|||TWO_SIDED|95.0|0.3767|0.599|||||Based on the estimate for slope parameter, a 2-sided 95% Confidence Interval (CI) for the slope was computed. Standard error of the mean is actually standard error of slope. Perfect dose proportionality would correspond to a slope of 1.|The basic model for the investigation of dose proportionality for fasted condition was a power model that describes the functional relationship between the dose and PK endpoints.||0.5990|0.3767|
72378527|NCT03123185|144265118|OTHER||Slope|0.7553|STANDARD_ERROR_OF_MEAN|0.0876|||TWO_SIDED|95.0|0.5736|0.937|||||Based on the estimate for slope parameter, a 2-sided 95% CI for the slope was computed. Standard error of the mean is actually standard error of slope. Perfect dose proportionality would correspond to a slope of 1.|The basic model for the investigation of dose proportionality for fed condition was a power model that describes the functional relationship between the dose and PK endpoints.||0.9370|0.5736|
72378528|NCT03123185|144265119|OTHER||Slope|0.4651|STANDARD_ERROR_OF_MEAN|0.1274|||TWO_SIDED|95.0|0.1935|0.7368|||||Based on the estimate for slope parameter, a 2-sided 95% CI for the slope was computed. Standard error of the mean is actually standard error of slope. Perfect dose proportionality would correspond to a slope of 1.|The basic model for the investigation of dose proportionality for fasted condition was a power model that describes the functional relationship between the dose and PK endpoints.||0.7368|0.1935|
72378529|NCT03123185|144265119|OTHER||Slope|0.6651|STANDARD_ERROR_OF_MEAN|0.1385|||TWO_SIDED|95.0|0.3679|0.9622|||Power model||Based on the estimate for slope parameter, a 2-sided 95% CI for the slope was computed. Standard error of the mean is actually standard error of slope. Perfect dose proportionality would correspond to a slope of 1.|The basic model for the investigation of dose proportionality for fed condition was a power model that describes the functional relationship between the dose and PK endpoints.||0.9622|0.3679|
72378530|NCT03505671|144265141|OTHER|||||||0.61|||||||ANCOVA|||||||0.61
72378531|NCT03505671|144265141|OTHER||Correlation Coefficient|0.15|||||TWO_SIDED||||||||Correlation between EORTC Sensory Subscale baseline and 12 weeks (overall, N=20)|||||
72378532|NCT03505671|144265141|OTHER||Correlation coefficient|0.25|||||TWO_SIDED||||||||Correlation between EORTC Sensory Subscale baseline and 12 weeks (intervention, N=9)|||||
72378533|NCT03505671|144265141|OTHER||Correlation coefficient|0.09|||||TWO_SIDED||||||||Correlation between EORTC Sensory Subscale baseline and 12 weeks (Usual Care, N=11)|||||
72378534|NCT03505671|144265142|OTHER|||||||0.91||||||P value for the motor subscale|ANCOVA|||||||0.91
72378535|NCT03505671|144265142|OTHER|||||||0.55||||||P value for autonomic subscale|ANCOVA|||||||0.55
72378536|NCT03505671|144265143|OTHER|||||||0.41||||||P value for baseline numbness or tingling severity data|Fisher Exact|||||||0.41
72378537|NCT03505671|144265143|OTHER|||||||0.22||||||P value for baseline numbness or tingling interference data|Fisher Exact|||||||0.22
72378538|NCT03505671|144265143|OTHER|||||||0.58||||||Week 12 p value for numbness or tingling severity data|Fisher Exact|||||||0.58
72378539|NCT03505671|144265143|OTHER|||||||0.12||||||P value for Week 12 numbness or tingling interference data|Fisher Exact|||||||0.12
72378540|NCT03505671|144265143|OTHER|||||||0.57||||||Week 12 - Baseline p value for numbness or tingling severity data|Fisher Exact|||||||0.57
72378541|NCT03505671|144265143|OTHER|||||||0.55||||||Week 12 - Baseline p value for numbness or tingling interference|Fisher Exact|||||||0.55
72378542|NCT03505671|144265144|OTHER|||||||0.99||||||P value for baseline numbness or tingling severity Grade 1-3|Fisher Exact|||||||0.99
72378543|NCT03505671|144265144|OTHER|||||||0.99||||||P value for 12 weeks numbness or tingling severity Grade 1-3|Fisher Exact|||||||0.99
72378544|NCT03505671|144265144|OTHER|||||||0.99||||||P value for week 12 - baseline change in numbness or tingling severity|Fisher Exact|||||||0.99
72378545|NCT03505671|144265145|OTHER|||||||0.99|||||||Fisher Exact|||||||0.99
72378546|NCT03505671|144265146|OTHER|||||||0.69|||||||t-test, 2 sided|||||||0.69
72378547|NCT03505671|144265147|OTHER|||||||0.46||||||P value for cross sectional area sural data|ANCOVA|||||||0.46
72378548|NCT03505671|144265147|OTHER|||||||0.22||||||P value for cross sectional area for median data|ANCOVA|||||||0.22
72378549|NCT03505671|144265148|OTHER|||||||0.2||||||P value for amplitude - sural data|ANCOVA|||||||0.20
72378550|NCT03505671|144265148|OTHER|||||||0.28||||||P value for amplitude - tibial, ankle|ANCOVA|||||||0.28
72378551|NCT03505671|144265148|OTHER|||||||0.13||||||P value for amplitude tibial, pop fossa|ANCOVA|||||||0.13
72378552|NCT03505671|144265148|OTHER|||||||0.71||||||P value for amplitude median, wrist|ANCOVA|||||||0.71
72378553|NCT03505671|144265148|OTHER|||||||0.46||||||P value for amplitude, median, elbow|ANCOVA|||||||0.46
72378554|NCT03505671|144265149|OTHER|||||||0.81||||||P value for latency sural data|ANCOVA|||||||0.81
72378555|NCT03505671|144265149|OTHER|||||||0.76||||||P value for latency tibial, ankle data|ANCOVA|||||||0.76
72378556|NCT03505671|144265149|OTHER|||||||0.24||||||P value for latency tibial, pop fossa|ANCOVA|||||||0.24
72556307|NCT00862563|144643978|SUPERIORITY_OR_OTHER||Difference between least squares means|-4.4|STANDARD_ERROR_OF_MEAN|1.1||0.0002|TWO_SIDED||||||ANOVA|||Comparison of Week 11 means for mean drinks per day obtained for the placebo and topiramate groups. Means used for the analysis are least squares means from a two-way repeated measures mixed models analysis, with Week (time) as the the within subject factor and treatment as the between group factor. Baseline values were used as covariates. .||||0.0002
72556308|NCT00862563|144643978|SUPERIORITY_OR_OTHER||Difference between least squares means|-4.1|STANDARD_ERROR_OF_MEAN|1.2||0.0007|TWO_SIDED||||||ANOVA|||Comparison of Week 12 means for mean drinks per day obtained for the placebo and topiramate groups. Means used for the analysis are least squares means from a two-way repeated measures mixed models analysis, with Week (time) as the the within subject factor and treatment as the between group factor. Baseline values were used as covariates.||||0.0007
72378557|NCT03505671|144265149|OTHER|||||||0.2||||||P value for latency median wrist data|ANCOVA|||||||0.20
72378558|NCT03505671|144265149|OTHER|||||||0.51||||||P value for latency median elbow data|ANCOVA|||||||0.51
72378559|NCT03505671|144265150|OTHER|||||||0.98||||||P value for velocity sural data|ANCOVA|||||||0.98
72378560|NCT03505671|144265150|OTHER|||||||0.03||||||P value for velocity tibial data|ANCOVA|||||||0.03
72378561|NCT03505671|144265150|OTHER|||||||0.81||||||P value for velocity median data|ANCOVA|||||||0.81
72378562|NCT02038829|144265152|SUPERIORITY|A sample size of 66 subjects (rounding to 72 for using Williams squares and 96 with dropouts) provides \~90% power to detect a 100 mL treatment difference in mean change trough FEV1 between SUN-101 and placebo at a Bonferroni-adjusted significance level of 0.0125 using a 2-tailed paired t-test and assuming a within-subject standard deviation for change in trough FEV1 of 176 and a within-subject correlation of 0.3.|LS Mean (SE)|0.0126|STANDARD_ERROR_OF_MEAN|0.0225||0.973|TWO_SIDED|95.0|-0.0318|0.0569||P-values were adjusted using Dunnett's method for comparing the multiple treatments to placebo. The comparison of aclidinium to placebo was performed at the 0.05 significance level to establish assay sensitivity.|LS Mean (SE)|||An mixed effects model was used with mean change from baseline in trough FEV1 as the response, with factors for treatment, period, sequence, baseline FEV1 as a covariate and a random effect for subject nested within sequence. The Kenward and Roger correction to the degrees of freedom was used. An unstructured covariance model was used to model intrasubject correlation.||0.0569|-0.0318|0.9730
72378563|NCT02038829|144265152|SUPERIORITY|A sample size of 66 subjects (rounding to 72 for using Williams squares and 96 with dropouts) provides \~90% power to detect a 100 mL treatment difference in mean change trough FEV1 between SUN-101 and placebo at a Bonferroni-adjusted significance level of 0.0125 using a 2-tailed paired t-test and assuming a within-subject standard deviation for change in trough FEV1 of 176 and a within-subject correlation of 0.3.|LS Mean (SE)|0.0822|STANDARD_ERROR_OF_MEAN|0.0225||0.0014|TWO_SIDED|95.0|0.038|0.1264||P-values were adjusted using Dunnett's method for comparing the multiple treatments to placebo. The comparison of aclidinium to placebo was performed at the 0.05 significance level to establish assay sensitivity.|LS Mean (SE)|||An mixed effects model was used with mean change from baseline in trough FEV1 as the response, with factors for treatment, period, sequence, baseline FEV1 as a covariate and a random effect for subject nested within sequence. The Kenward and Roger correction to the degrees of freedom was used. An unstructured covariance model was used to model intrasubject correlation.||0.1264|0.0380|0.0014
72378564|NCT02038829|144265152|SUPERIORITY|A sample size of 66 subjects (rounding to 72 for using Williams squares and 96 with dropouts) provides \~90% power to detect a 100 mL treatment difference in mean change trough FEV1 between SUN-101 and placebo at a Bonferroni-adjusted significance level of 0.0125 using a 2-tailed paired t-test and assuming a within-subject standard deviation for change in trough FEV1 of 176 and a within-subject correlation of 0.3.|LS Mean (SE)|0.1088|STANDARD_ERROR_OF_MEAN|0.0226|<|0.0001|TWO_SIDED|95.0|0.0644|0.1532||P-values were adjusted using Dunnett's method for comparing the multiple treatments to placebo. The comparison of aclidinium to placebo was performed at the 0.05 significance level to establish assay sensitivity.|LS Mean (SE)|||An mixed effects model was used with mean change from baseline in trough FEV1 as the response, with factors for treatment, period, sequence, baseline FEV1 as a covariate and a random effect for subject nested within sequence. The Kenward and Roger correction to the degrees of freedom was used. An unstructured covariance model was used to model intrasubject correlation.||0.1532|0.0644|<0.0001
72395128|NCT02289690|144296700|SUPERIORITY||Hazard Ratio (HR)|0.665||||0.059|TWO_SIDED|80.0|0.503|0.88|||Log Rank|Two-sided log-rank test stratified by lactate dehydrogenase (LDH) level|Hazard ratio estimate was obtained from a Cox proportional hazards model stratified by LDH level. A hazard ratio \< 1 favors veliparib in combination with carboplatin and etoposide followed by veliparib maintenance monotherapy (Arm A).|"The primary efficacy analysis in the Phase 2 portion of the study was the comparison of PFS among participants who received veliparib in combination with carboplatin and etoposide followed by veliparib maintenance monotherapy (Arm A) vs. placebo in combination with carboplatin and etoposide followed by placebo maintenance monotherapy (Arm C).~Statistical significance was determined by a two-sided p-value ≤ 0.2"||0.880|0.503|0.059
72378565|NCT02038829|144265152|SUPERIORITY|A sample size of 66 subjects (rounding to 72 for using Williams squares and 96 with dropouts) provides \~90% power to detect a 100 mL treatment difference in mean change trough FEV1 between SUN-101 and placebo at a Bonferroni-adjusted significance level of 0.0125 using a 2-tailed paired t-test and assuming a within-subject standard deviation for change in trough FEV1 of 176 and a within-subject correlation of 0.3.|LS Mean (SE)|0.1375|STANDARD_ERROR_OF_MEAN|0.0226|<|0.0001|TWO_SIDED|95.0|0.0931|0.1818||P-values were adjusted using Dunnett's method for comparing the multiple treatments to placebo. The comparison of aclidinium to placebo was performed at the 0.05 significance level to establish assay sensitivity.|LS Mean (SE)|||An mixed effects model was used with mean change from baseline in trough FEV1 as the response, with factors for treatment, period, sequence, baseline FEV1 as a covariate and a random effect for subject nested within sequence. The Kenward and Roger correction to the degrees of freedom was used. An unstructured covariance model was used to model intrasubject correlation||0.1818|0.0931|<0.0001
72378566|NCT02038829|144265152|SUPERIORITY|A sample size of 66 subjects (rounding to 72 for using Williams squares and 96 with dropouts) provides \~90% power to detect a 100 mL treatment difference in mean change trough FEV1 between SUN-101 and placebo at a Bonferroni-adjusted significance level of 0.0125 using a 2-tailed paired t-test and assuming a within-subject standard deviation for change in trough FEV1 of 176 and a within-subject correlation of 0.3.|LS Mean (SE)|0.1567|STANDARD_ERROR_OF_MEAN|0.0226|<|0.0001|TWO_SIDED|95.0|0.1121|0.2012||P-values were adjusted using Dunnett's method for comparing the multiple treatments to placebo. The comparison of aclidinium to placebo was performed at the 0.05 significance level to establish assay sensitivity.|LS Mean (SE)|||An mixed effects model was used with mean change from baseline in trough FEV1 as the response, with factors for treatment, period, sequence, baseline FEV1 as a covariate and a random effect for subject nested within sequence. The Kenward and Roger correction to the degrees of freedom was used. An unstructured covariance model was used to model intrasubject correlation.||0.2012|0.1121|<0.0001
72378567|NCT02038829|144265153|SUPERIORITY|A sample size of 78 subjects (rounding to 84 for using Williams squares) provides \~80% power to detect a 55 mL treatment difference in mean change trough FEV1 between SUN-101 and placebo at a Bonferroni-adjusted significance level of 0.0125 using a 2-tailed paired t-test and assuming a within-subject standard deviation for change in AUC(0-12) of 143 and a within-subject correlation of 0.3.|LS Mean (SE)|0.0526|STANDARD_ERROR_OF_MEAN|0.0184||0.0046|TWO_SIDED|95.0|0.0163|0.0888|||LS Mean (SE)|||An mixed effects model was used with standardized FEV1 AUC(0-12) on Day 7 as the response, with factors for treatment, period, sequence, baseline FEV1 as a covariate and a random effect for subject nested within sequence. The Kenward and Roger correction to the degrees of freedom was used. An unstructured covariance model was used to model intrasubject correlation.||0.0888|0.0163|0.0046
72378568|NCT02038829|144265153|SUPERIORITY|A sample size of 78 subjects (rounding to 84 for using Williams squares) provides \~80% power to detect a 55 mL treatment difference in mean change trough FEV1 between SUN-101 and placebo at a Bonferroni-adjusted significance level of 0.0125 using a 2-tailed paired t-test and assuming a within-subject standard deviation for change in AUC(0-12) of 143 and a within-subject correlation of 0.3.|LS Mean (SE)|0.0842|STANDARD_ERROR_OF_MEAN|0.0185|<|0.0001|TWO_SIDED|95.0|0.0478|0.1206|||LS Mean (SE)|||An mixed effects model was used with standardized FEV1 AUC(0-12) on Day 7 as the response, with factors for treatment, period, sequence, baseline FEV1 as a covariate and a random effect for subject nested within sequence. The Kenward and Roger correction to the degrees of freedom was used. An unstructured covariance model was used to model intrasubject correlation.||0.1206|0.0478|<0.0001
72378569|NCT02038829|144265153|NON_INFERIORITY|A sample size of 78 subjects (rounding to 84 for using Williams squares) provides \~80% power to detect a 55 mL treatment difference in mean change trough FEV1 between SUN-101 and placebo at a Bonferroni-adjusted significance level of 0.0125 using a 2-tailed paired t-test and assuming a within-subject standard deviation for change in AUC(0-12) of 143 and a within-subject correlation of 0.3.|LS Mean (SE)|0.1255|STANDARD_ERROR_OF_MEAN|0.0186|<|0.0001|TWO_SIDED|95.0|0.089|0.1621|||LS Mean (SE)|||An mixed effects model was used with standardized FEV1 AUC(0-12) on Day 7 as the response, with factors for treatment, period, sequence, baseline FEV1 as a covariate and a random effect for subject nested within sequence. The Kenward and Roger correction to the degrees of freedom was used. An unstructured covariance model was used to model intrasubject correlation.||0.1621|0.0890|<0.0001
72378570|NCT02038829|144265153|SUPERIORITY|A sample size of 78 subjects (rounding to 84 for using Williams squares) provides \~80% power to detect a 55 mL treatment difference in mean change trough FEV1 between SUN-101 and placebo at a Bonferroni-adjusted significance level of 0.0125 using a 2-tailed paired t-test and assuming a within-subject standard deviation for change in AUC(0-12) of 143 and a within-subject correlation of 0.3.|LS Mean (SE)|0.1963|STANDARD_ERROR_OF_MEAN|0.0184|<|0.0001|TWO_SIDED|95.0|0.1601|0.2325|||LS Mean (SE)|||An mixed effects model was used with standardized FEV1 AUC(0-12) on Day 7 as the response, with factors for treatment, period, sequence, baseline FEV1 as a covariate and a random effect for subject nested within sequence. The Kenward and Roger correction to the degrees of freedom was used. An unstructured covariance model was used to model intrasubject correlation.||0.2325|0.1601|<0.0001
72378571|NCT02038829|144265153|SUPERIORITY|A sample size of 78 subjects (rounding to 84 for using Williams squares) provides \~80% power to detect a 55 mL treatment difference in mean change trough FEV1 between SUN-101 and placebo at a Bonferroni-adjusted significance level of 0.0125 using a 2-tailed paired t-test and assuming a within-subject standard deviation for change in AUC(0-12) of 143 and a within-subject correlation of 0.3.|LS Mean (SE)|0.1902|STANDARD_ERROR_OF_MEAN|0.0186|<|0.0001|TWO_SIDED|95.0|0.1537|0.2268|||LS Mean (SE)|||An mixed effects model was used with standardized FEV1 AUC(0-12) on Day 7 as the response, with factors for treatment, period, sequence, baseline FEV1 as a covariate and a random effect for subject nested within sequence. The Kenward and Roger correction to the degrees of freedom was used. An unstructured covariance model was used to model intrasubject correlation.||0.2268|0.1537|<0.0001
72378572|NCT01993836|144265187|OTHER||Spearman Correlation|-0.03|||||TWO_SIDED|95.0|-0.23|0.18||||||Correlation between 6-week change in Tau and continuous cognitive index||0.18|-0.23|
72378573|NCT01993836|144265187|OTHER||Spearman Correlation|-0.08|||||TWO_SIDED|95.0|-0.29|0.13||||||Correlation between 6-week change in Abeta and continuous cognitive index||0.13|-0.29|
72378574|NCT01993836|144265187|OTHER||Spearman Correlation|0.12|||||TWO_SIDED|95.0|-0.08|0.32||||||Correlation between 6-week change in P-Tau and continuous cognitive index||0.32|-0.08|
72378575|NCT01993836|144265188|OTHER||Spearman Correlation|0.02|||||TWO_SIDED|95.0|-0.19|0.22||||||Correlation between 6-week change in Tau/Abeta ratio and continuous cognitive index||0.22|-0.19|
72378576|NCT01993836|144265188|OTHER||Spearman Correlation|0.16|||||TWO_SIDED|95.0|-0.05|0.34||||||Correlation between 6-week change in P-Tau/Abeta ratio and continuous cognitive index||0.34|-0.05|
72378577|NCT01993836|144265189|OTHER|||||||0.36|||||||t-test, 2 sided|||||||0.360
72378578|NCT01993836|144265190|OTHER|||||||0.532|||||||Wilcoxon (Mann-Whitney)|||Difference in 6-week Tau Change between anesthetic groups||||0.532
72378579|NCT01993836|144265190|OTHER|||||||0.565|||||||Wilcoxon (Mann-Whitney)|||Difference in 6-week Abeta Change between anesthetic groups||||0.565
72378580|NCT01993836|144265190|OTHER|||||||0.11|||||||Wilcoxon (Mann-Whitney)|||Difference in 6-week P-Tau Change between anesthetic groups||||0.110
72378581|NCT01993836|144265191|OTHER|||||||0.439|||||||Wilcoxon (Mann-Whitney)|||Difference in 6-week Tau/Abeta ratio Change between anesthetic groups||||0.439
72378582|NCT01993836|144265191|OTHER|||||||0.082|||||||Wilcoxon (Mann-Whitney)|||Difference in 6-week P-Tau/Abeta Change between anesthetic groups||||0.082
72378583|NCT01993836|144265192|OTHER|||||||0.801|||||||Wilcoxon Signed Rank|||||||0.801
72378584|NCT04369924|144265205|SUPERIORITY||F test for time by condition interaction|1.49||||0.25|TWO_SIDED||||||ANOVA|||||||.25
72378585|NCT04369924|144265206|SUPERIORITY||F test for time by condition interaction|2.8||||0.12|TWO_SIDED||||||ANOVA|||||||.12
72378586|NCT04369924|144265207|SUPERIORITY||F test for time by condition interaction|0.7||||0.7|TWO_SIDED||||||ANOVA|||||||.70
72378587|NCT04369924|144265208|SUPERIORITY||F test for time by condition interaction|3.67||||0.07|TWO_SIDED||||||ANOVA|||||||.07
72378588|NCT04369924|144265209|SUPERIORITY||Slope|0.16||||0.82|TWO_SIDED||||||Mixed Models Analysis|||||||.82
72378589|NCT04369924|144265210|SUPERIORITY||Slope|-2.41||||0.59|TWO_SIDED||||||Mixed Models Analysis|||||||.59
72378590|NCT02554279|144265211|NON_INFERIORITY|The study had at least 80% power, to demonstrate the non-inferiority of menotropin to recombinant FSH at 1-sided significance level of 0.025 with a -12% non-inferiority margin.|Absolute difference|4.7|||||TWO_SIDED|95.0|-2.7|12.1||||||Null hypothesis was defined as the difference between ongoing pregnancy rate of participants randomized and treated with menotropin and recombinant FSH, as ≤-12%.||12.1|-2.7|
72378591|NCT02554279|144265212|OTHER||Absolute difference|1.2|||||TWO_SIDED|95.0|-6.6|8.9||||||||8.9|-6.6|
72378592|NCT02554279|144265213|OTHER||Absolute difference|3.8|||||TWO_SIDED|95.0|-3.8|11.3||||||||11.3|-3.8|
72378593|NCT02554279|144265214|OTHER||Absolute difference|-9.5|||||TWO_SIDED|95.0|-19.2|0.2||||||||0.2|-19.2|
72378594|NCT02360605|144265233|SUPERIORITY|||||||0.61||||||p-values control for age (in years), race (African American vs Caucasian and Hispanic), gender, and literacy (2 categories) The a priori threshold for statistical significance was p\<0.05|Mixed Models Analysis|||FIT completion rates were defined as the percentage of FIT tests returned. Screening ratios were defined as the PC to AC ratio of FIT completion rates. Multivariate analyses adjusting for age, race, gender, and literacy level were done using generalized linear models. Multivariate analyses adjusting for age, race, gender, and literacy level were done using generalized linear models. A test for interaction between literacy level and study arm were assessed.||||0.61
72378595|NCT02360605|144265234|SUPERIORITY|||||||0.3||||||p-values control for age (in years), race (African American vs Caucasian and Hispanic), gender, and literacy (2 categories) The a priori threshold for statistical significance was p\<0.05|Mixed Models Analysis|||Multivariate analyses adjusting for age, race, gender, and health literacy level were done using generalized linear models. A test for interaction between study arm and each of literacy level, age, gender and race was performed to determine whether treatment effect differed by levels of these factors. An unadjusted test for the main effect of each of health literacy level, age, gender, race and study arm was performed to determine whether screening rates differed by levels of these factors.||||0.30
72378596|NCT02360605|144265235|SUPERIORITY|||||||0.97||||||p-values control for age (in years), race (African American vs Caucasian and Hispanic), gender, and literacy (2 categories) The a priori threshold for statistical significance was p\<0.05|Mixed Models Analysis|||Multivariate analyses adjusting for age, race, gender, and health literacy level were done using generalized linear models. A test for interaction between study arm and each of literacy level, age, gender and race was performed to determine whether treatment effect differed by levels of these factors. An unadjusted test for the main effect of each of health literacy level, age, gender, race and study arm was performed to determine whether screening rates differed by levels of these factors.||||0.97
72378597|NCT01933789|144265242|SUPERIORITY||Probit regression coefficient|1.145|||<|0.001|TWO_SIDED|95.0|0.844|1.446||No adjustment for multiple tests. A priori threshold of 0.05 for statistical significance.|Clustered probit regression|Patients clustered under clinicians. Bivariate model; there were no confounders.|Control group coded 0; intervention group coded 1.|||1.446|0.844|<0.001
72378598|NCT01933789|144265243|SUPERIORITY||Probit regression coefficient|1.251|||<|0.001|TWO_SIDED|95.0|0.92|1.583||No adjustment for multiple tests. A priori threshold of 0.05 for statistical significance.|Clustered probit regression|Patients clustered under clinicians. Bivariate model; there were no confounders.|Control group coded 0; intervention group coded 1.|||1.583|0.920|<0.001
72378599|NCT01933789|144265244|SUPERIORITY||Probit regression coefficient|1.381|||<|0.001|TWO_SIDED|95.0|1.046|1.715||No adjustment for multiple tests. A priori threshold of 0.05 for statistical significance.|Clustered probit regression|Patients clustered under clinicians. Bivariate model; there were no confounders.|Control group coded 0; intervention group coded 1.|||1.715|1.046|<0.001
72378600|NCT01933789|144265246|SUPERIORITY||Probit regression coefficient|0.334||||0.073|TWO_SIDED|95.0|-0.031|0.699||No adjustment for multiple tests. A priori threshold of 0.05 for statistical significance.|Clustered probit regression|Patients clustered under clinicians. Adjusted for the patient's treatment preference (focus on life extension vs. comfort care).|Control group coded 0; intervention group coded 1.|Occurrence of goal-concordant care||0.699|-0.031|0.073
72378601|NCT01933789|144265247|SUPERIORITY||Probit regression coefficient|0.481||||0.017|TWO_SIDED|95.0|0.085|0.877||No adjustment for multiple tests. A priori threshold of 0.05 for statistical significance.|Clustered probit regression|Patients clustered under clinicians. Adjusted for the patient's treatment preference (focus on life extension vs. comfort care).|Control group coded 0; intervention group coded 1.|||0.877|0.085|0.017
72378602|NCT01933789|144265248|SUPERIORITY||Probit regression coefficient|2.022||||0.01|TWO_SIDED|95.0|0.476|3.569||No adjustment for multiple tests. A priori threshold of 0.05 for statistical significance.|Clustered probit regression|Patients clustered under clinicians. Adjusted for the latent variable as measured at baseline.|Control group coded 0; intervention group coded 1.|||3.569|0.476|0.010
72378603|NCT01933789|144265249|SUPERIORITY||Tobit regression coefficient|2.209||||0.001|TWO_SIDED|95.0|0.939|3.479||No adjustment for multiple tests. A priori threshold of 0.05 for statistical significance.|Clustered Tobit regression|Patients clustered under clinicians. Adjusted for the outcome variable as measured at baseline.|Control group coded 0; intervention group coded 1.|"Patient rating of clinician's quality of communication about patient's feelings about getting sicker.~Variable with range 0-11, defined as censored from below because of strong floor effect."||3.479|0.939|0.001
72556309|NCT00862563|144643978|SUPERIORITY_OR_OTHER||Difference between least squares means|-1.64|STANDARD_ERROR_OF_MEAN|1.1||0.15|TWO_SIDED|||||p\<0.05 considered to be significant|ANOVA|||Comparison of Week 10 means for mean drinks per day obtained for the placebo and levetiracetam groups. Means used for the analysis are least squares means from a two-way repeated measures mixed models analysis, with Week (time) as the the within subject factor and treatment as the between group factor. Baseline values were used as covariates.||||0.15
72378604|NCT01933789|144265249|SUPERIORITY||Tobit regression coefficient|1.237||||0.122|TWO_SIDED|95.0|-0.33|2.804||No adjustment for multiple tests. A priori threshold of 0.05 for statistical significance.|Clustered Tobit regression|Patients clustered under clinicians. Adjusted for the outcome variable as measured at baseline.|Control group coded 0; intervention group coded 1.|"Patient rating of clinician's quality of communication about details of getting sicker.~Variable with range 0-11, defined as censored from below because of strong floor effect."||2.804|-0.330|0.122
72378605|NCT01933789|144265249|SUPERIORITY||Tobit regression coefficient|2.329||||0.098|TWO_SIDED|95.0|-0.426|5.083||No adjustment for multiple tests. A priori threshold of 0.05 for statistical significance.|Clustered Tobit regression|Patients clustered under clinicians. Adjusted for the outcome variable as measured at baseline and clinician specialty.|Control group coded 0; intervention group coded 1.|"Patient rating of clinician's quality of communication about how long the patient might have to live.~Variable with range 0-11, defined as censored from below because of strong floor effect."||5.083|-0.426|0.098
72378606|NCT01933789|144265249|SUPERIORITY||Tobit regression coefficient|1.573||||0.352|TWO_SIDED|95.0|-1.742|4.887||No adjustment for multiple tests. A priori threshold of 0.05 for statistical significance.|Clustered Tobit regression|Pts clustered under clins. Adjusted for outcome variable as measured at baseline: pt. minority status, education, income; clinician type \& specialty.|Control group coded 0; intervention group coded 1.|"Patient rating of clinician's quality of communication about what dying might be like.~Variable with range 0-11, defined as censored from below because of strong floor effect."||4.887|-1.742|0.352
72378607|NCT01933789|144265249|SUPERIORITY||Tobit regression coefficient|4.625|||<|0.001|TWO_SIDED|95.0|2.06|7.19||No adjustment for multiple tests. A priori threshold of 0.05 for statistical significance.|Clustered Tobit regression|Patients clustered under clinicians. Adjusted for the outcome variable as measured at baseline.|Control group coded 0; intervention group coded 1.|"Patient rating of clinician's quality of communication about patient's involvement in end-of-life treatment decisions.~Variable with range 0-11, defined as censored from below because of strong floor effect."||7.190|2.060|<0.001
72378608|NCT01933789|144265249|SUPERIORITY||Tobit regression coefficient|2.404||||0.002|TWO_SIDED|95.0|0.898|3.909||No adjustment for multiple tests. A priori threshold of 0.05 for statistical significance.|Clustered Tobit regression|Patients clustered under clinicians. Adjusted for the outcome variable as measured at baseline.|Control group coded 0; intervention group coded 1.|"Patient rating of clinician's quality of communication about things in life that are important to the patient.~Variable with range 0-11, defined as censored from below because of strong floor effect."||3.909|0.898|0.002
72378609|NCT01933789|144265249|SUPERIORITY||Tobit regression coefficient|2.455||||0.075|TWO_SIDED|95.0|-0.25|5.159||No adjustment for multiple tests. A priori threshold of 0.05 for statistical significance.|Clustered Tobit regression|Patients clustered under clinicians. Adjusted for the outcome variable as measured at baseline and clinician type.|Control group coded 0; intervention group coded 1.|"Patient rating of clinician's quality of communication about patient's religious/spiritual beliefs.~Variable with range 0-11, defined as censored from below because of strong floor effect."||5.159|-0.250|0.075
72378610|NCT01933789|144265250|SUPERIORITY||Probit regression coefficient|-0.103||||0.369|TWO_SIDED|95.0|-0.327|0.122||No adjustment for multiple tests. A priori threshold of 0.05 for statistical significance.|Clustered probit regression|Patients clustered under clinicians. Adjusted for baseline level of the latent depression variable and for the patient racial/ethnic minority status.|Control group coded 0; intervention group coded 1.|Symptoms of depression - Two-indicator latent variable with measurement invariance imposed between groups and over time.||0.122|-0.327|0.369
72378611|NCT01933789|144265251|SUPERIORITY||Probit regression coefficient|0.263||||0.536|TWO_SIDED|95.0|-0.571|1.097||No adjustment for multiple tests. A priori threshold of 0.05 for statistical significance.|Clustered robust linear regression|Patients clustered under clinicians. Adjusted for baseline level of the PHQ-8 composite score.|Control group coded 0; intervention group coded 1.|Symptoms of depression: standard PHQ-8 composite score.||1.097|-0.571|0.536
72378612|NCT01933789|144265252|SUPERIORITY||Probit regression coefficient|0.208||||0.106|TWO_SIDED|95.0|-0.044|0.461||No adjustment for multiple tests. A priori threshold of 0.05 for statistical significance.|Clustered probit regression|Pts clustered under clins. Adjusted for baseline level of the latent depression var; pt age, minority status, education, health status; clin specialty|Control group coded 0; intervention group coded 1.|Symptoms of depression: Two-indicator latent variable with measurement invariance imposed between groups and over time||0.461|-0.044|0.106
72556310|NCT00862563|144643978|SUPERIORITY_OR_OTHER||Difference between least squares means|-2.9|STANDARD_ERROR_OF_MEAN|1.2||0.014|TWO_SIDED|||||p\< 0.05 is considered to be significant.|ANOVA|||Comparison of Week 11 means for mean drinks per day obtained for the placebo and levetiracetam groups. Means used for the analysis are least squares means from a two-way repeated measures mixed models analysis, with Week (time) as the the within subject factor and treatment as the between group factor. Baseline values were used as covariate values.||||0.014
72378613|NCT01933789|144265253|SUPERIORITY||Probit regression coefficient|0.446||||0.343|TWO_SIDED|95.0|-0.476|1.368||No adjustment for multiple tests. A priori threshold of 0.05 for statistical significance.|Clustered robust linear regression|Patients clustered under clinicians. Adjusted for baseline level of the PHQ-8 composite score and clinician specialty.|Control group coded 0; intervention group coded 1.|Symptoms of depression: Standard PHQ-8 composite score||1.368|-0.476|0.343
72378614|NCT01933789|144265254|SUPERIORITY||Probit regression coefficient|-0.034||||0.734|TWO_SIDED|95.0|-0.232|0.163||No adjustment for multiple tests. A priori threshold of 0.05 for statistical significance.|Clustered probit regression|Patients clustered under clinicians. Adjusted for baseline level of the latent anxiety variable.|Control group coded 0; intervention group coded 1.|Symptoms of anxiety: Two-indicator latent variable with measurement invariance imposed between groups and over time||0.163|-0.232|0.734
72378615|NCT01933789|144265255|SUPERIORITY||Tobit regression coefficient|0.041||||0.935|TWO_SIDED|95.0|-0.946|1.028||No adjustment for multiple tests. A priori threshold of 0.05 for statistical significance.|Clustered Tobit regression|Pts clustered under clins. Clustered Tobit regression because strong floor effect on composite score. Adjusted for baseline level of composite score.|Control group coded 0; intervention group coded 1.|Symptoms of anxiety: Standard GAD-7 composite score||1.028|-0.946|0.935
72378616|NCT01933789|144265256|SUPERIORITY||Probit regression coefficient|-0.042||||0.689|TWO_SIDED|95.0|-0.247|0.163||No adjustment for multiple tests. A priori threshold of 0.05 for statistical significance.|Clustered probit regression|Patients clustered under clinicians. Adjusted for baseline level of the latent anxiety variable.|Control group coded 0; intervention group coded 1.|Symptoms of anxiety: Two-indicator latent variable with measurement invariance imposed between groups and over time||0.163|-0.247|0.689
72378617|NCT01933789|144265257|SUPERIORITY||Tobit regression coefficient|-0.105||||0.852|TWO_SIDED|95.0|-1.204|0.995||"No adjustment for multiple tests. A priori threshold of 0.05 for statistical significance.~Patients clustered under clinicians. Clustered Tobit regression because of strong floor effect on composite score."|Clustered Tobit regression|Adjusted for baseline level of the GAD-7 composite score.|Control group coded 0; intervention group coded 1.|||0.995|-1.204|0.852
72378618|NCT01933789|144265258|SUPERIORITY||probit regression coefficient|-0.221||||0.418|TWO_SIDED|95.0|-0.923|0.482||"No adjustment for multiple tests. A priori threshold of 0.05 for statistical significance.~Patients clustered under clinicians."|clustered probit regression|Adjusted for confounding by patient race and health status and by clinician type and specialty|Control group coded 0; intervention group coded 1.|||0.482|-0.923|0.418
72378619|NCT01933789|144265259|SUPERIORITY||probit regression coefficient|0.175||||0.568|TWO_SIDED|95.0|-0.613|0.962||"No adjustment for multiple tests. A priori threshold of 0.05 for statistical significance.~Patients clustered under clinicians."|clustered probit regression|No covariate adjustment.|Control group coded 0; intervention group coded 1.|||0.962|-0.613|0.568
72378620|NCT01933789|144265260|SUPERIORITY||probit regression coefficient|0.14||||0.592|TWO_SIDED|95.0|-0.534|0.815||"No adjustment for multiple tests. A priori threshold of 0.05 for statistical significance.~Patients clustered under clinicians."|clustered probit regression|No covariate adjustment|Control group coded 0; intervention group coded 1.|||0.815|-0.534|0.592
72378621|NCT01933789|144265263|SUPERIORITY||probit regression coefficient|-0.179||||0.705|TWO_SIDED|95.0|-1.398|1.04||"No adjustment for multiple tests. A priori threshold of 0.05 for statistical significance.~Patients clustered under clinicians."|clustered probit regression|No covariate adjustment|Control group coded 0; intervention group coded 1.|||1.040|-1.398|0.705
72378622|NCT01933789|144265264|SUPERIORITY||probit regression coefficient|0.123||||0.644|TWO_SIDED|95.0|-0.56|0.805||"No adjustment for multiple tests. A priori threshold of 0.05 for statistical significance.~Patients clustered under clinicians."|clustered probit regression|No covariate adjustment|Control group coded 0; intervention group coded 1.|||0.805|-0.560|0.644
72556311|NCT00862563|144643978|SUPERIORITY_OR_OTHER||Difference between least squares means|-2.0|STANDARD_ERROR_OF_MEAN|1.2||0.1|TWO_SIDED|||||p\< 0.05 is considered to be significant.|ANOVA|||Comparison of Week 12 means for mean drinks per day obtained for the placebo and levetiracetam groups. Means used for the analysis are least squares means s from a two-way repeated measures mixed models analysis, with Week (time) as the the within subject factor and treatment as the between group factor. Baseline values were used as covariates.||||0.1
72618500|NCT01026038|144768103|SUPERIORITY_OR_OTHER||GMC ratio|1.04|||||TWO_SIDED|95.0|0.82|1.32||||||Serotype 9V: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||1.32|0.82|
72618501|NCT01026038|144768103|SUPERIORITY_OR_OTHER||GMC ratio|1.09|||||TWO_SIDED|95.0|0.86|1.39||||||Serotype 9V: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.39|0.86|
72378623|NCT01933789|144265265|SUPERIORITY||probit regression coefficient|-0.165||||0.908|TWO_SIDED|95.0|-3.833|3.503||"No adjustment for multiple tests. A priori threshold of 0.05 for statistical significance.~Patients clustered under clinicians."|clustered probit regression|Adjusted for confounding by patient education and health status and by clinician gender.|Control group coded 0; intervention group coded 1.|||3.503|-3.833|0.908
72378624|NCT01933789|144265266|SUPERIORITY||probit regression coefficient|-0.121||||0.552|TWO_SIDED|95.0|-0.646|0.403||"No adjustment for multiple tests. A priori threshold of 0.05 for statistical significance.~Patients clustered under clinicians."|clustered probit regression|No covariate adjustment.|Control group coded 0; intervention group coded 1.|||0.403|-0.646|0.552
72378625|NCT01933789|144265267|SUPERIORITY||probit regression coefficient|-0.293||||0.372|TWO_SIDED|95.0|-1.139|0.553||"No adjustment for multiple tests. A priori threshold of 0.05 for statistical significance.~Patients clustered under clinicians."|clustered probit regression|No covariate adjustment.|Control group coded 0; intervention group coded 1.|||0.553|-1.139|0.372
72378626|NCT01933789|144265268|SUPERIORITY||probit regression coefficient|-0.13||||0.501|TWO_SIDED|95.0|-0.63|0.369||"No adjustment for multiple tests. A priori threshold of 0.05 for statistical significance.~Patients clustered under clinicians."|clustered probit regression|No covariate adjustment.|Control group coded 0; intervention group coded 1.|||0.369|-0.630|0.501
72378627|NCT01933789|144265269|SUPERIORITY||probit regression coefficient|-0.39||||0.192|TWO_SIDED|95.0|-1.16|0.38||"No adjustment for multiple tests. A priori threshold of 0.05 for statistical significance.~Patients clustered under clinicians."|clustered probit regression|No covariate adjustment.|Control group coded 0; intervention group coded 1.|||0.380|-1.160|0.192
72378628|NCT01933789|144265270|SUPERIORITY||probit regression coefficient|-0.014||||0.94|TWO_SIDED|95.0|-0.489|0.461||"No adjustment for multiple tests. A priori threshold of 0.05 for statistical significance.~Patients clustered under clinicians."|clustered probit regression|No covariate adjustment.|Control group coded 0; intervention group coded 1.|||0.461|-0.489|0.940
72378629|NCT01933789|144265271|SUPERIORITY||probit regression coefficient|-0.229||||0.47|TWO_SIDED|95.0|-1.044|0.587||"No adjustment for multiple tests. A priori threshold of 0.05 for statistical significance.~Patients clustered under clinicians."|clustered probit regression|No covariate adjustment.|Control group coded 0; intervention group coded 1.|||0.587|-1.044|0.470
72378630|NCT01933789|144265272|SUPERIORITY||probit regression coefficient|-0.01||||0.955|TWO_SIDED|95.0|-0.474|0.454||"No adjustment for multiple tests. A priori threshold of 0.05 for statistical significance.~Patients clustered under clinicians."|clustered probit regression|No covariate adjustment.|Control group coded 0; intervention group coded 1.|||0.454|-0.474|0.955
72378631|NCT01933789|144265273|SUPERIORITY||probit regression coefficient|-0.287||||0.303|TWO_SIDED|95.0|-1.005|0.431||"No adjustment for multiple tests. A priori threshold of 0.05 for statistical significance.~Patients clustered under clinicians."|clustered probit regression|No covariate adjustment.|Control group coded 0; intervention group coded 1.|||0.431|-1.005|0.303
72378632|NCT01277081|144265280|SUPERIORITY_OR_OTHER||Adjusted Mean difference|0.72|||<|0.0001|TWO_SIDED|95.0|0.58|0.86|||Repeated Measure Analysis|Repeated measures analysis with factors for time and treatment\*time interaction. Baseline score was adjusted as part of the repeated measures series.|Difference was first named treatment minus second named treatment such that a positive difference favours the first named treatment|Null Hypothesis considered no difference in treatments being compared for breathing score over the first 15 minutes compared to baseline.||0.86|0.58|<0.0001
72378633|NCT01277081|144265281|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.58|||<|0.0001|TWO_SIDED|95.0|0.44|0.72|||Repeated measures analysis|Repeated measures analysis with factors for time and treatment\*time interaction. Baseline score was adjusted as part of the repeated measures series.|Difference was first named treatment minus second named treatment such that a positive difference favours the first named treatment.|Null hypothesis considered no difference in treatments being compared for breathing score over 60 minutes.||0.72|0.44|<0.0001
72378634|NCT01277081|144265282|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.5|||<|0.0001|TWO_SIDED|95.0|0.36|0.65|||Repeated measures analysis|Repeated measures analysis with factors for time and treatment\*time interaction. Baseline score was adjusted as part of the repeated measures series.|Difference was first named treatment minus second named treatment such that a positive difference favours the first named treatment.|Null Hypothesis considered no difference in treatments being compared for cold symptoms score after 60 minutes.||0.65|0.36|<0.0001
72378635|NCT01277081|144265283|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.52|||<|0.0001|TWO_SIDED|95.0|0.38|0.67|||Repeated measures analysis|Repeated measures analysis with factors for time and treatment\*time interaction. Baseline score was adjusted as part of the repeated measures series.|Difference was first named treatment minus second named treatment such that a positive difference favours the first named treatment.|Null hypothesis considered two treatments being compared to be equal for cold symptom score after 60 minutes.||0.67|0.38|<0.0001
72378636|NCT00740051|144265286|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.57|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001||95.0|-0.86|-0.29||No adjustment of p-values|ANCOVA|||Linagliptin versus Placebo||-0.29|-0.86|<0.0001
72378637|NCT00740051|144265287|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001||95.0|-0.88|-0.32||No adjustment of p-values|ANCOVA|||Linagliptin versus Placebo. The primary analysis performed at the interim was re-run at the end of the study to accommodate changes made to the final study database.||-0.32|-0.88|<0.0001
72378638|NCT00740051|144265288|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-20.5|STANDARD_ERROR_OF_MEAN|5.4||0.0002||95.0|-31.1|-9.9||No adjustment of p-values|ANCOVA|||Linagliptin versus Placebo||-9.9|-31.1|0.0002
72378639|NCT00740051|144265289|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.576||||0.0374||95.0|1.057|6.279||No adjustment of p-values|Regression, Logistic|||Linagliptin versus Placebo||6.279|1.057|0.0374
72556312|NCT00862563|144643979|SUPERIORITY_OR_OTHER||Mean difference Week 12|8.9|STANDARD_ERROR_OF_MEAN|3.6||0.015|TWO_SIDED|||||p\< 0.05 is considered to be significant.|ANOVA|||Comparison between mean values obtained for the topiramate and placebo groups for Week 12. Model generated least mean squares were used for this analysis.||||0.015
72556313|NCT00862563|144643979|SUPERIORITY_OR_OTHER||Mean Difference Week 12|0.98|STANDARD_ERROR_OF_MEAN|3.6||0.784|TWO_SIDED|||||p\< 0.05 is considered to be significant.|ANOVA|||Comparison of means for the zonisamide and placebo group for Week 12. Mixed models generated means were used in this analysis.||||0.784
72378640|NCT00740051|144265290|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.285||||0.1281||95.0|0.71|15.196||No adjustment of p-values|Regression, Logistic|||Linagliptin vs. Placebo||15.196|0.710|0.1281
72378641|NCT00740051|144265291|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.801||||0.0046||95.0|1.374|5.711||No adjustment of p-values|Regression, Logistic|||Linagliptin versus Placebo||5.711|1.374|0.0046
72378642|NCT01673282|144265323|SUPERIORITY_OR_OTHER||Least Square Mean|-0.24|STANDARD_ERROR_OF_MEAN|0.06|=|0.0003|TWO_SIDED|95.0|-0.36|-0.11|||ANCOVA|||Based on an ANCOVA model for absolute change in ratio of dose and DDD with group as a fixed effect and the ratio of dose and DDD at Baseline as a covariate.||-0.11|-0.36|=0.0003
72378643|NCT03935399|144265324|SUPERIORITY|Exploratory analysis without power calculation||||||0.83|||||||ANOVA|Repeated measures one factor ANOVA||Exploratory analysis without power calculation||||0.83
72378644|NCT03935399|144265325|SUPERIORITY|Exploratory analysis without power calculation||||||0.92|||||||ANOVA|One factor repeated measures ANOVA||Exploratory analysis without power calculation||||0.92
72378645|NCT03935399|144265326|SUPERIORITY|Exploratory analysis without power calculation||||||0.79|||||||ANOVA|One factor repeated measures ANOVA||Exploratory analysis without power calculation||||0.79
72556314|NCT00862563|144643979|SUPERIORITY_OR_OTHER||Mean difference Week 12|3.65|STANDARD_ERROR_OF_MEAN|3.3||0.264|TWO_SIDED|||||p\< 0.05 is considered to be significant.|ANOVA|||Comparison of means for the levetiracetam and placebo groups for Week 12. Model generated least mean squares were used for this analysis.||||0.264
72378646|NCT03935399|144265327|SUPERIORITY|Exploratory analysis without power calculation||||||0.93||||||Exploratory analysis without power calculation|ANOVA|One factor repeated measures ANOVA||||||0.93
72378647|NCT03935399|144265328|SUPERIORITY|Exploratory analysis without power calculation||||||0.89||||||Exploratory analysis without power calculation|ANOVA|Two factor repeated measures ANOVA||||||0.89
72378648|NCT03935399|144265329|SUPERIORITY|Exploratory analysis without power calculation||||||0.83||||||Exploratory analysis without power calculation|ANOVA|Two way repeated measures ANOVA||||||0.83
72378649|NCT03935399|144265330|SUPERIORITY|Exploratory analysis without power caclulation||||||0.57||||||Exploratory analysis without power caclulation|ANOVA|Two way repeated measures ANOVA||||||0.57
72378650|NCT01112683|144265331|SUPERIORITY_OR_OTHER|||||||0.403|ONE_SIDED|90.0|||||Mixed Models Analysis|An alpha level of 0.05 or lower represents statistical significance, no correction was made for multiple comparisons to minimize type II errors.||20 subjects per group were expected to provide 60% power to detect a between-group mean difference of 1.2 correct patterns (change from baseline to week 16) on the Paired Associates Learning and to provide 40% power to detect a between-group mean difference of 1.2 patterns recognized on the Pattern Recognition Memory. A two-sided test at type I error rate of 5% was used. Sample size incorporated an inflation factor of 20% to account for ineligibility of 10% of randomized participants.||||0.403
72378651|NCT01112683|144265332|SUPERIORITY_OR_OTHER|||||||0.371|ONE_SIDED|90.0||||This P-Value refers to the SIB-R Broad independence score.|Mixed Models Analysis|An alpha level of 0.05 or lower represents statistical significance, no correction was made for multiple comparisons to minimize type II errors.||No power calculations were performed for the secondary measures.||||0.371
72378652|NCT02915874|144265344|SUPERIORITY||Slope|-1.13|STANDARD_ERROR_OF_MEAN|0.47||0.02|TWO_SIDED|||||a priori threshold: 0.05|Mixed Models Analysis|||||||0.02
72378653|NCT02915874|144265345|SUPERIORITY||Slope|-1.02|STANDARD_ERROR_OF_MEAN|0.78||0.19|TWO_SIDED|||||a priori threshold: 0.05|Mixed Models Analysis|||||||0.19
72378654|NCT02915874|144265346|SUPERIORITY||Slope|2.07|STANDARD_ERROR_OF_MEAN|1.86||0.27|TWO_SIDED|||||a priori threshold: 0.05|Mixed Models Analysis|||||||0.27
72378655|NCT02915874|144265347|SUPERIORITY||Slope|-0.49|STANDARD_ERROR_OF_MEAN|21.3||0.98|TWO_SIDED|||||a priori threshold: 0.05|Mixed Models Analysis|||||||0.98
72378656|NCT02915874|144265348|SUPERIORITY||Slope|1.03|STANDARD_ERROR_OF_MEAN|2.58||0.69|TWO_SIDED|||||a priori: 0.05|Mixed Models Analysis|||||||0.69
72378657|NCT02915874|144265349|SUPERIORITY||Slope|-2.77|STANDARD_ERROR_OF_MEAN|4.93||0.58|TWO_SIDED||||||Mixed Models Analysis|||||||0.58
72378658|NCT02915874|144265350|SUPERIORITY||Slope|-1.02|STANDARD_ERROR_OF_MEAN|0.58||0.08|TWO_SIDED|||||a priori threshold: 0.05|Mixed Models Analysis|||||||0.08
72556315|NCT00862563|144643980|SUPERIORITY_OR_OTHER||Difference between least squares means|-24.4|STANDARD_ERROR_OF_MEAN|9.7||0.013|TWO_SIDED|||||p\< 0.05 is considered to be significant.|ANOVA|||Comparison of Week 10 means for mean percent heavy drinking days obtained for the placebo and zonisamide groups Means used for the analysis are least squares means from a two-way repeated measures mixed models analysis, with Week (time) as the the within subject factor and treatment as the between group factor. Baseline values were used as covariates.||||0.013
72618502|NCT01026038|144768103|SUPERIORITY_OR_OTHER||GMC ratio|1.05|||||TWO_SIDED|95.0|0.79|1.39||||||Serotype 9V: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.39|0.79|
72618503|NCT01026038|144768103|SUPERIORITY_OR_OTHER||GMC ratio|1.02|||||TWO_SIDED|95.0|0.77|1.34||||||Serotype 14: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||1.34|0.77|
72378659|NCT03036800|144265395|SUPERIORITY||Odds Ratio (OR)|5.19|||<|0.001|TWO_SIDED|95.0|2.09|12.88|||Regression, Logistic|||A logistic regression with a binary outcome of weight loss of ≥15% from baseline at 52 weeks was fitted. The main covariate was randomised arm, with the model also being adjusted for the stratification variables: site and baseline body mass index (≥45kg/m2; \<45kg/m2).||12.88|2.09|<0.001
72378660|NCT03036800|144265396|SUPERIORITY||Odds Ratio (OR)|5.94|||<|0.001|TWO_SIDED|95.0|2.45|14.4|||Regression, Logistic|||A logistic regression with a binary outcome of weight loss of ≥15% from baseline at 52 weeks was fitted. The main covariate was randomised arm, with the model also being adjusted for the stratification variables: site and baseline body mass index (≥45kg/m2; \<45kg/m2).||14.4|2.45|<0.001
72378661|NCT03036800|144265397|SUPERIORITY||Odds Ratio (OR)|5.04||||0.002|TWO_SIDED|95.0|1.81|14.01|||Regression, Logistic|||A logistic regression with a binary outcome of weight loss of ≥15% from baseline at 52 weeks was fitted. The main covariate was randomised arm, with the model also being adjusted for the stratification variables: site and baseline body mass index (≥45kg/m2; \<45kg/m2).||14.01|1.81|0.002
72378662|NCT03036800|144265398|SUPERIORITY||Odds Ratio (OR)|5.24||||0.002|TWO_SIDED|95.0|1.88|14.64|||Regression, Logistic|||A logistic regression with a binary outcome of weight loss of ≥15% from baseline at 52 weeks was fitted. The main covariate was randomised arm, with the model also being adjusted for the stratification variables: site and baseline body mass index (≥45kg/m2; \<45kg/m2).||14.64|1.88|0.002
72378663|NCT03036800|144265415|SUPERIORITY||Odds Ratio (OR)|10.12|||<|0.001|TWO_SIDED|95.0|5.26|19.48|||Regression, Logistic|||A logistic regression with a binary outcome of weight loss of ≥5% from baseline at 16 weeks was fitted. The main covariate was randomised arm, with the model also being adjusted for the stratification variables: site and baseline body mass index (≥45kg/m2; \<45kg/m2).||19.48|5.26|<0.001
72378664|NCT03036800|144265416|SUPERIORITY||Odds Ratio (OR)|5.17|||<|0.001|TWO_SIDED|95.0|2.86|9.36|||Regression, Logistic|||A logistic regression with a binary outcome of weight loss of ≥5% from baseline at 32 weeks was fitted. The main covariate was randomised arm, with the model also being adjusted for the stratification variables: site and baseline body mass index (≥45kg/m2; \<45kg/m2).||9.36|2.86|<0.001
72378665|NCT03036800|144265417|SUPERIORITY||Odds Ratio (OR)|4.16|||<|0.001|TWO_SIDED|95.0|2.39|7.22|||Regression, Logistic|||A logistic regression with a binary outcome of weight loss of ≥5% from baseline at 52 weeks was fitted. The main covariate was randomised arm, with the model also being adjusted for the stratification variables: site and baseline body mass index (≥45kg/m2; \<45kg/m2).||7.22|2.39|<0.001
72378666|NCT03036800|144265418|SUPERIORITY||Odds Ratio (OR)|2.44||||0.01|TWO_SIDED|95.0|1.23|4.84|||Regression, Logistic|||A logistic regression with a binary outcome of weight loss of ≥5% from baseline at 104 weeks was fitted. The main covariate was randomised arm, with the model also being adjusted for the stratification variables: site and baseline body mass index (≥45kg/m2; \<45kg/m2).||4.84|1.23|0.010
72378667|NCT03036800|144265419|SUPERIORITY||Odds Ratio (OR)|5.14|||<|0.001|TWO_SIDED|95.0|2.14|12.39|||Regression, Logistic|||A logistic regression with a binary outcome of weight loss of ≥10% from baseline at 16 weeks was fitted. The main covariate was randomised arm, with the model also being adjusted for the stratification variables: site and baseline body mass index (≥45kg/m2; \<45kg/m2).||12.39|2.14|<0.001
72378668|NCT03036800|144265420|SUPERIORITY||Odds Ratio (OR)|6.53|||<|0.001|TWO_SIDED|95.0|3.32|12.86|||Regression, Logistic|||A logistic regression with a binary outcome of weight loss of ≥10% from baseline at 32 weeks was fitted. The main covariate was randomised arm, with the model also being adjusted for the stratification variables: site and baseline body mass index (≥45kg/m2; \<45kg/m2).||12.86|3.32|<0.001
72378669|NCT03036800|144265421|SUPERIORITY||Odds Ratio (OR)|8.08|||<|0.001|TWO_SIDED|95.0|3.8|17.16|||Regression, Logistic|||A logistic regression with a binary outcome of weight loss of ≥10% from baseline at 52 weeks was fitted. The main covariate was randomised arm, with the model also being adjusted for the stratification variables: site and baseline body mass index (≥45kg/m2; \<45kg/m2).||17.16|3.80|<0.001
72378670|NCT03036800|144265422|SUPERIORITY||Odds Ratio (OR)|2.28||||0.065|TWO_SIDED|95.0|0.95|5.47|||Regression, Logistic|||A logistic regression with a binary outcome of weight loss of ≥10% from baseline at 104 weeks was fitted. The main covariate was randomised arm, with the model also being adjusted for the stratification variables: site and baseline body mass index (≥45kg/m2; \<45kg/m2).||5.47|0.95|0.065
72378671|NCT03036800|144265423|SUPERIORITY||Odds Ratio (OR)|2.84||||0.206|TWO_SIDED|95.0|0.56|14.34|||Regression, Logistic|||A logistic regression with a binary outcome of weight loss of ≥15% from baseline at 16 weeks was fitted. The main covariate was randomised arm, with the model also being adjusted for the stratification variables: site and baseline body mass index (≥45kg/m2; \<45kg/m2).||14.34|0.56|0.206
72378672|NCT03036800|144265424|SUPERIORITY||Odds Ratio (OR)|3.23||||0.023|TWO_SIDED|95.0|1.17|8.9|||Regression, Logistic|||A logistic regression with a binary outcome of weight loss of ≥32% from baseline at 16 weeks was fitted. The main covariate was randomised arm, with the model also being adjusted for the stratification variables: site and baseline body mass index (≥45kg/m2; \<45kg/m2).||8.90|1.17|0.023
72378673|NCT03036800|144265425|SUPERIORITY||Odds Ratio (OR)|4.11||||0.07|TWO_SIDED|95.0|0.89|18.93|||Regression, Logistic|||A logistic regression with a binary outcome of weight loss of ≥15% from baseline at 104 weeks was fitted. The main covariate was randomised arm, with the model also being adjusted for the stratification variables: site and baseline body mass index (≥45kg/m2; \<45kg/m2).||18.93|0.89|0.070
72378674|NCT03036800|144265426|SUPERIORITY||Odds Ratio (OR)|0.59||||0.601|TWO_SIDED|95.0|0.08|4.24|||Regression, Logistic|||A logistic regression with a binary outcome of weight loss of ≥15% from baseline at 104 weeks was fitted. The main covariate was randomised arm, with the model also being adjusted for the stratification variables: site and baseline body mass index (≥45kg/m2; \<45kg/m2).||4.24|0.08|0.601
72378675|NCT03036800|144265427|SUPERIORITY||Mean Difference (Net)|-4.63|||<|0.001|TWO_SIDED|95.0|-5.85|-3.4|||Regression, Linear|||A linear regression model was fitted for the continuous outcome of absolute weight change (kg) from baseline at 16 weeks. The main covariate was randomised arm, with the model also being adjusted for the stratification variables: site and baseline body mass index (≥45kg/m2; \<45kg/m2).||-3.4|-5.85|<0.001
72378676|NCT03036800|144265428|SUPERIORITY||Mean Difference (Net)|-5.89|||<|0.001|TWO_SIDED|95.0|-7.76|-4.02|||Regression, Linear|||A linear regression model was fitted for the continuous outcome of absolute weight change (kg) from baseline at 32 weeks. The main covariate was randomised arm, with the model also being adjusted for the stratification variables: site and baseline body mass index (≥45kg/m2; \<45kg/m2).||-4.02|-7.76|<0.001
72378677|NCT03036800|144265429|SUPERIORITY||Mean Difference (Net)|-6.87|||<|0.001|TWO_SIDED|95.0|-9.03|-4.71|||Regression, Linear|||A linear regression model was fitted for the continuous outcome of absolute weight change (kg) from baseline at 52 weeks. The main covariate was randomised arm, with the model also being adjusted for the stratification variables: site and baseline body mass index (≥45kg/m2; \<45kg/m2).||-4.71|-9.03|<0.001
72433608|NCT00991276|144380371|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-14.5|STANDARD_ERROR_OF_MEAN|2.91|<|0.0001|TWO_SIDED|95.0|-20.26|-8.74||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||-8.74|-20.26|<0.0001
72618504|NCT01026038|144768103|SUPERIORITY_OR_OTHER||GMC ratio|1.04|||||TWO_SIDED|95.0|0.79|1.37||||||Serotype 14: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.37|0.79|
72378678|NCT03036800|144265430|SUPERIORITY||Mean Difference (Net)|-5.44|||<|0.001|TWO_SIDED|95.0|-8.34|-2.53|||Regression, Linear|||A linear regression model was fitted for the continuous outcome of absolute weight change (kg) from baseline at 104 weeks. The main covariate was randomised arm, with the model also being adjusted for the stratification variables: site and baseline body mass index (≥45kg/m2; \<45kg/m2).||-2.53|-8.34|<0.001
72378679|NCT03036800|144265431|SUPERIORITY||Mean Difference (Net)|-3.72|||<|0.001|TWO_SIDED|95.0|-4.63|-2.8|||Regression, Linear|||A linear regression model was fitted for the continuous outcome of relative weight change (%) from baseline at 16 weeks. The main covariate was randomised arm, with the model also being adjusted for the stratification variables: site and baseline body mass index (≥45kg/m2; \<45kg/m2).||-2.80|-4.63|<0.001
72378680|NCT03036800|144265432|SUPERIORITY||Mean Difference (Net)|-4.7|||<|0.001|TWO_SIDED|95.0|-6.14|-3.25|||Regression, Linear|||A linear regression model was fitted for the continuous outcome of relative weight change (%) from baseline at 32 weeks. The main covariate was randomised arm, with the model also being adjusted for the stratification variables: site and baseline body mass index (≥45kg/m2; \<45kg/m2).||-3.25|-6.14|<0.001
72378681|NCT03036800|144265433|SUPERIORITY||Mean Difference (Net)|-5.37|||<|0.001|TWO_SIDED|95.0|-7.02|-3.71|||Regression, Linear|||A linear regression model was fitted for the continuous outcome of relative weight change (%) from baseline at 52 weeks. The main covariate was randomised arm, with the model also being adjusted for the stratification variables: site and baseline body mass index (≥45kg/m2; \<45kg/m2).||-3.71|-7.02|<0.001
72378682|NCT03036800|144265434|SUPERIORITY||Mean Difference (Net)|-4.1||||0.001|TWO_SIDED|95.0|-6.42|-1.77|||Regression, Linear|||A linear regression model was fitted for the continuous outcome of relative weight change (%) from baseline at 104 weeks. The main covariate was randomised arm, with the model also being adjusted for the stratification variables: site and baseline body mass index (≥45kg/m2; \<45kg/m2).||-1.77|-6.42|0.001
72378683|NCT03036800|144265435|SUPERIORITY||Mean Difference (Net)|-2.7|||<|0.001|TWO_SIDED|95.0|-3.5|-1.91|||Regression, Linear|||A linear regression model was fitted for the continuous outcome of absolute BMI change (kg/m2) from baseline at 52 weeks. The main covariate was randomised arm, with the model also being adjusted for the stratification variables: site and baseline body mass index (≥45kg/m2; \<45kg/m2).||-1.91|-3.5|<0.001
72378684|NCT03036800|144265436|SUPERIORITY||Mean Difference (Net)|-1.89|||<|0.001|TWO_SIDED|95.0|-2.91|-0.86|||Regression, Linear|||A linear regression model was fitted for the continuous outcome of absolute BMI change (kg/m2) from baseline at 104 weeks. The main covariate was randomised arm, with the model also being adjusted for the stratification variables: site and baseline body mass index (≥45kg/m2; \<45kg/m2).||-0.86|-2.91|<0.001
72378685|NCT03036800|144265437|SUPERIORITY||Mean Difference (Net)|-3.28||||0.01|TWO_SIDED|95.0|-5.77|-0.8|||Regression, Linear|||A linear regression model was fitted for the continuous outcome of absolute waist circumference change (cm) from baseline at 52 weeks. The main covariate was randomised arm, with the model also being adjusted for the stratification variables: site and baseline body mass index (≥45kg/m2; \<45kg/m2).||-0.80|-5.77|0.01
72378686|NCT03036800|144265438|SUPERIORITY||Mean Difference (Net)|-5.51||||0.003|TWO_SIDED|95.0|-9.09|-1.94|||Regression, Linear|||A linear regression model was fitted for the continuous outcome of absolute waist circumference change (cm) from baseline at 104 weeks. The main covariate was randomised arm, with the model also being adjusted for the stratification variables: site and baseline body mass index (≥45kg/m2; \<45kg/m2).||-1.94|-9.09|0.003
72378687|NCT03036800|144265458|SUPERIORITY||Odds Ratio (OR)|10.53|||<|0.001|TWO_SIDED|95.0|3.83|28.97|||Regression, Logistic|||A logistic regression with a binary outcome of weight loss of ≥5% from baseline at 104 weeks was fitted. The main covariate was randomised arm, with the model also being adjusted for the stratification variables: site and baseline body mass index (≥45kg/m2; \<45kg/m2).||28.97|3.83|<0.001
72378688|NCT03036800|144265459|SUPERIORITY||Odds Ratio (OR)|23.1|||<|0.001|TWO_SIDED|95.0|7.55|70.67|||Regression, Logistic|||A logistic regression with a binary outcome of weight loss of ≥10% from baseline at 16 weeks was fitted. The main covariate was randomised arm, with the model also being adjusted for the stratification variables: site and baseline body mass index (≥45kg/m2; \<45kg/m2).||70.67|7.55|<0.001
72378689|NCT03036800|144265462|SUPERIORITY||Odds Ratio (OR)|7.71|||<|0.001|TWO_SIDED|95.0|2.75|21.6|||Regression, Logistic|||A logistic regression with a binary outcome of weight loss of ≥10% from baseline at 104 weeks was fitted. The main covariate was randomised arm, with the model also being adjusted for the stratification variables: site and baseline body mass index (≥45kg/m2; \<45kg/m2).||21.60|2.75|<0.001
72378690|NCT03036800|144265463|SUPERIORITY||Odds Ratio (OR)|6.14||||0.032|TWO_SIDED|95.0|1.16|32.32|||Regression, Logistic|||A logistic regression with a binary outcome of weight loss of ≥15% from baseline at 16 weeks was fitted. The main covariate was randomised arm, with the model also being adjusted for the stratification variables: site and baseline body mass index (≥45kg/m2; \<45kg/m2).||32.32|1.16|0.032
72378691|NCT03036800|144265464|SUPERIORITY||Odds Ratio (OR)|11.48|||<|0.001|TWO_SIDED|95.0|3.8|34.67|||Regression, Logistic|||A logistic regression with a binary outcome of weight loss of ≥15% from baseline at 32 weeks was fitted. The main covariate was randomised arm, with the model also being adjusted for the stratification variables: site and baseline body mass index (≥45kg/m2; \<45kg/m2).||34.67|3.80|<0.001
72378692|NCT03036800|144265466|SUPERIORITY||Odds Ratio (OR)|13.63||||0.003|TWO_SIDED|95.0|2.47|75.09|||Regression, Logistic|||A logistic regression with a binary outcome of weight loss of ≥15% from baseline at 104 weeks was fitted. The main covariate was randomised arm, with the model also being adjusted for the stratification variables: site and baseline body mass index (≥45kg/m2; \<45kg/m2).||75.09|2.47|0.003
72378693|NCT03036800|144265467|SUPERIORITY||Odds Ratio (OR)|0.59||||0.601|TWO_SIDED|95.0|0.08|4.24|||Regression, Logistic|||A logistic regression with a binary outcome of maintenance of weight loss of ≥15% at 104 weeks was fitted. The main covariate was randomised arm, with the model also being adjusted for the stratification variables: site and baseline body mass index (≥45kg/m2; \<45kg/m2).||4.24|0.08|0.601
72378694|NCT03036800|144265468|SUPERIORITY||Mean Difference (Net)|-6.55|||<|0.001|TWO_SIDED|95.0|-7.81|-5.29|||Regression, Linear|||A linear regression model was fitted for the continuous outcome of relative weight change (%) from baseline at 16 weeks. The main covariate was randomised arm, with the model also being adjusted for the stratification variables: site and baseline body mass index (≥45kg/m2; \<45kg/m2).||-5.29|-7.81|<0.001
72433609|NCT00991276|144380371|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|11.35|STANDARD_ERROR_OF_MEAN|2.88||0.0001|TWO_SIDED|95.0|5.65|17.04||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||17.04|5.65|0.0001
72618505|NCT01026038|144768103|SUPERIORITY_OR_OTHER||GMC ratio|1.02|||||TWO_SIDED|95.0|0.74|1.4||||||Serotype 14: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.40|0.74|
72378695|NCT03036800|144265469|SUPERIORITY||Mean Difference (Net)|-9.59|||<|0.001|TWO_SIDED|95.0|-11.3|-7.88|||Regression, Linear|||A linear regression model was fitted for the continuous outcome of relative weight change (%) from baseline at 32 weeks. The main covariate was randomised arm, with the model also being adjusted for the stratification variables: site and baseline body mass index (≥45kg/m2; \<45kg/m2).||-7.88|-11.30|<0.001
72378696|NCT03036800|144265470|SUPERIORITY||Mean Difference (Net)|-13.51|||<|0.001|TWO_SIDED|95.0|-15.51|-11.51|||Regression, Linear|||A linear regression model was fitted for the continuous outcome of relative weight change (%) from baseline at 52 weeks. The main covariate was randomised arm, with the model also being adjusted for the stratification variables: site and baseline body mass index (≥45kg/m2; \<45kg/m2).||-11.51|-15.51|<0.001
72378697|NCT03036800|144265471|SUPERIORITY||Mean Difference (Net)|-9.3|||<|0.001|TWO_SIDED|95.0|-12.35|-6.26|||Regression, Linear|||A linear regression model was fitted for the continuous outcome of relative weight change (%) from baseline at 104 weeks. The main covariate was randomised arm, with the model also being adjusted for the stratification variables: site and baseline body mass index (≥45kg/m2; \<45kg/m2).||-6.26|-12.35|<0.001
72378698|NCT03036800|144265472|SUPERIORITY||Mean Difference (Net)|-6.16|||<|0.001|TWO_SIDED|95.0|-7.03|-5.28|||Regression, Linear|||A linear regression model was fitted for the continuous outcome of absolute BMI change (kg/m2) from baseline at 52 weeks. The main covariate was randomised arm, with the model also being adjusted for the stratification variables: site and baseline body mass index (≥45kg/m2; \<45kg/m2).||-5.28|-7.03|<0.001
72378699|NCT03036800|144265473|SUPERIORITY||Mean Difference (Net)|-4.22|||<|0.001|TWO_SIDED|95.0|-5.56|-2.89|||Regression, Linear|||A linear regression model was fitted for the continuous outcome of absolute BMI change (kg/m2) from baseline at 104 weeks. The main covariate was randomised arm, with the model also being adjusted for the stratification variables: site and baseline body mass index (≥45kg/m2; \<45kg/m2).||-2.89|-5.56|<0.001
72378700|NCT03036800|144265474|SUPERIORITY||Median Difference (Net)|-8.8|||<|0.001|TWO_SIDED|95.0|-11.96|-5.64|||Regression, Linear|||A linear regression model was fitted for the continuous outcome of absolute waist circumference change (cm) from baseline at 52 weeks. The main covariate was randomised arm, with the model also being adjusted for the stratification variables: site and baseline body mass index (≥45kg/m2; \<45kg/m2).||-5.64|-11.96|<0.001
72378701|NCT03036800|144265475|SUPERIORITY||Median Difference (Net)|-9.59||||0.001|TWO_SIDED|95.0|-14.91|-4.27|||Regression, Linear|||A linear regression model was fitted for the continuous outcome of absolute waist circumference change (cm) from baseline at 104 weeks. The main covariate was randomised arm, with the model also being adjusted for the stratification variables: site and baseline body mass index (≥45kg/m2; \<45kg/m2).||-4.27|-14.91|0.001
72378702|NCT05985980|144265476|EQUIVALENCE|The null hypothesis is true that the ST/HR index (μV/bpm) ıs similar between the early and late follicular phases||||||0.521|||||||t-test, 2 sided|||||||0.521
72378703|NCT05985980|144265477|EQUIVALENCE|High-sensitive cardiac troponin T (hs-cTnT) levels before and after ETT at the early and late follicular phases are compared.||||||0.109|||||||ANOVA|||High-sensitive cardiac troponin T (hs-cTnT) levels before and after ETT at the early and late follicular phases are compared.||||0.109
72378704|NCT05985980|144265478|EQUIVALENCE|ETT maximal exercise capacity (METs score) is compared between the early and late follicular phases of menstrual cycle||||||0.111|||||||t-test, 2 sided|||ETT maximal exercise capacity (METs score) is compared between the early and late follicular phases of menstrual cycle||||0.111
72378705|NCT05985980|144265479|EQUIVALENCE|ETT ST/HR slope (μV/bpm) is compared between the early and late follicular phases of menstrual cycle||||||0.414|||||||t-test, 2 sided|||ETT ST/HR slope (μV/bpm) is compared between the early and late follicular phases of menstrual cycle||||0.414
72378706|NCT05985980|144265480|EQUIVALENCE|Maximal horizontal or down slope ST segment depression (mm) during exercise treadmill test is compared between the early and late follicular phases of menstrual cycle||||||0.062|||||||t-test, 2 sided|||Maximal horizontal or down slope ST segment depression (mm) during exercise treadmill test is compared between the early and late follicular phases of menstrual cycle||||0.062
72378707|NCT05985980|144265481|EQUIVALENCE|Estrogen levels increase at the late follicular phase.|||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
72618506|NCT01026038|144768103|SUPERIORITY_OR_OTHER||GMC ratio|0.75|||||TWO_SIDED|95.0|0.57|0.97||||||Serotype 18C: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||0.97|0.57|
72378708|NCT02478398|144265521|SUPERIORITY||Mean Difference (Final Values)|-2.73|||<|0.001|TWO_SIDED|95.0|-3.45|-2.0|||ANOVA|Model included fixed effects of treatment, baseline asthma status, age group, pollen season, and pollen region nested within pollen season||||-2.00|-3.45|< 0.001
72378709|NCT02478398|144265522|SUPERIORITY||Difference in LS Mean|-1.86|||<|0.001|TWO_SIDED|95.0|-2.46|-1.27|||ANOVA|Model included fixed effects of treatment, baseline asthma status, age group, pollen season, and pollen region nested within pollen season||||-1.27|-2.46|< 0.001
72378710|NCT02478398|144265523|SUPERIORITY||Mean Difference (Final Values)|-1.4|||<|0.001|TWO_SIDED|95.0|-1.81|-0.99|||ANOVA|Model included fixed effects of treatment, baseline asthma status, age group, pollen season, and pollen region nested within pollen season||||-0.99|-1.81|< 0.001
72378711|NCT02478398|144265524|SUPERIORITY||Mean Difference (Final Values)|-1.84|||<|0.001|TWO_SIDED|95.0|-2.6|-1.08|||Zero-Inflated Log-Normal Model|Model included fixed effects of treatment, baseline asthma, age group, pollen season, and pollen region nested within pollen season||||-1.08|-2.60|< 0.001
72378712|NCT02478398|144265525|OTHER||Difference in % estimates|37.61|||<|0.001|TWO_SIDED|95.0|31.82|43.12|||Miettinen & Nurminen|||||43.12|31.82|< 0.001
72378713|NCT02478398|144265526|OTHER||Difference in % estimates|0.39|||=|0.32|TWO_SIDED|95.0|-0.57|1.53|||Miettinen & Nurminen|||||1.53|-0.57|= 0.320
72378714|NCT02478398|144265527|OTHER||Difference in % estimates|0.0|||=|0.996|TWO_SIDED|95.0|-0.92|0.92|||Miettinen & Nurminen|||||0.92|-0.92|= 0.996
72378715|NCT03160859|144265553|SUPERIORITY|||||||0.62|||||||Chi-squared|||Chi Square||||0.62
72378716|NCT02522871|144265557|NON_INFERIORITY|non-inferiority margin = 0.075|Difference of Proportion|-0.132|||<|0.0001|ONE_SIDED|95.0||-0.049|||one-sided Farrington and Manning|||||-0.049||<0.0001
72378717|NCT02522871|144265557|NON_INFERIORITY|non-inferiority margin = 0.075|Difference of Proportion|-0.145|||<|0.0001|ONE_SIDED|95.0||-0.062|||one-sided Farrington and Manning|||||-0.062||<0.0001
72378718|NCT02522871|144265558|NON_INFERIORITY|non-inferiority margin of 1.0|Mean Difference (Final Values)|-0.03|||<|0.0001|TWO_SIDED|95.0|-0.084|0.025|||t-test, 1 sided|||||0.025|-0.084|<0.0001
72378719|NCT02522871|144265559|NON_INFERIORITY|non-inferiority margin = 0.075|Difference of Proportion|0.0||||0.0004|ONE_SIDED|95.0||0.036|||one-sided Farrington and Manning|||||0.036||0.0004
72378720|NCT02522871|144265559|NON_INFERIORITY|non-inferiority margin = 0.075|Difference of Proportion|0.0||||0.0004|ONE_SIDED|95.0||0.036|||one-sided Farrington and Manning|||||0.036||0.0004
72378721|NCT02522871|144265560|NON_INFERIORITY|non-inferiority margin = 0.075|Difference of Proportion|-0.001||||0.0006|ONE_SIDED|95.0||0.038|||one-sided Farrington and Manning|||||0.038||0.0006
72378722|NCT02522871|144265560|NON_INFERIORITY|non-inferiority margin = 0.075|Difference of Proportion|-0.001||||0.0006|ONE_SIDED|95.0||0.038|||one-sided Farrington and Manning|||||0.038||0.0006
72378723|NCT00509262|144265563|NON_INFERIORITY_OR_EQUIVALENCE|The pre-specified non-inferiority margin was 0.4%; i.e., non-inferiority required that the upper boundary of the 95% confidence interval for the treatment difference (sitagliptin minus glipizide) to be less than 0.4%.|Difference in least squares mean|-0.11|STANDARD_DEVIATION|0.74|||TWO_SIDED|95.0|-0.29|0.06|||ANCOVA||Based on analysis of covariance with terms for treatment, renal insufficiency stratum at Visit 4/Week -2 (moderate, or severe), prior diabetes pharmacotherapy (on or not on oral antihyperglycemic agent), and a covariate for baseline A1C.|||0.06|-0.29|
72378724|NCT00509262|144265564|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.8||||0.001|TWO_SIDED|95.0|-17.1|-4.8|||Miettirnen& Nurminen method||Miettirnen \& Nurminen method stratified by renal insufficiency stratum at Visit 4/Week -2 (moderate or severe) \& prior diabetes pharmacotherapy|||-4.8|-17.1|0.001
72378725|NCT00509262|144265565|SUPERIORITY_OR_OTHER||Difference in least squares mean|7.1|STANDARD_DEVIATION|38.3|||TWO_SIDED|95.0|-1.9|16.1|||ANCOVA||Analysis of covariance with terms for treatment, renal insufficiency stratum at Visit 4/Week -2 (moderate or severe), prior diabetes pharmacotherapy (on or not on oral antihyperglycemic agent), and a covariate for baseline Fasting Plasma Glucose.|||16.1|-1.9|
72378726|NCT00509262|144265566|SUPERIORITY_OR_OTHER||Difference in least squares mean|-1.8|STANDARD_DEVIATION|3.8|<|0.001|TWO_SIDED|95.0|-2.6|-1.0|||ANCOVA||Analysis of covariance with terms of treatment, renal insufficiency stratum at Visit 4/Week -2 (moderate or severe), prior diabetes pharmacotherapy (on or not on oral antihyperglycemic agent), and a covariate for baseline body weight.|||-1.0|-2.6|<0.001
72378727|NCT02635646|144265661|OTHER|T test for mean comparisons between independent groups||||||0.844||||||Significant p value less than 0.05|t-test, 2 sided|||||||0.844
72378728|NCT02635646|144265662|OTHER|||||||0.624|||||||t-test, 2 sided|||||||0.624
72378729|NCT02635646|144265663|OTHER||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
72378730|NCT02635646|144265664|OTHER|||||||0.516|||||||t-test, 2 sided|||||||0.516
72378731|NCT02635646|144265665|OTHER||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
72378732|NCT00400153|144265674|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin is 0.05 liter|Mean Difference (Final Values)|-0.0035|STANDARD_ERROR_OF_MEAN|0.0095||0.7135||95.0|-0.0222|0.0152|||ANCOVA|||||0.0152|-0.0222|0.7135
72378733|NCT00400153|144265675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.047|STANDARD_ERROR_OF_MEAN|0.01|<|0.0001||95.0|0.028|0.066|||ANCOVA|||||0.066|0.028|< 0.0001
72378734|NCT00400153|144265676|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin is 0.05 liters|Mean Difference (Final Values)|-0.017|STANDARD_ERROR_OF_MEAN|0.011||0.1389||95.0|-0.039|0.005|||ANCOVA|||||0.005|-0.039|0.1389
72504964|NCT00196937|144541121|NON_INFERIORITY|Non-inferiority with respect to seroconversion was shown if, for both anti-HPV-16 and anti-HPV-18 antibodies, the upper limit of the 95% confidence interval (CI) for the difference \[Cervarix (15-25 years) Group minus Cervarix (26-45 years) Group\] was below 10%.|Difference in SCR|0.0|||||TWO_SIDED|95.0|-1.97|2.29||||||Immune response to anti-HPV-16 in terms of SCR: To evaluate if the immunogenicity (as determined by ELISA) of the Cervarix vaccine, one month after the third dose (Month 7), in young women 26 - 45 years of age is non-inferior to that in women 15 - 25 years of age.||2.29|-1.97|
72378735|NCT00400153|144265677|NON_INFERIORITY_OR_EQUIVALENCE|This analysis is purely exploratory. Non-inferiority margin is not established for this comparison.|Mean Difference (Final Values)|-0.016|STANDARD_ERROR_OF_MEAN|0.01||0.124||95.0|-0.036|0.004|||ANCOVA|||||0.004|-0.036|0.124
72378736|NCT00400153|144265678|NON_INFERIORITY_OR_EQUIVALENCE|This analysis is purely exploratory. Non-inferiority margin is not established for this comparison.|Mean Difference (Final Values)|-0.007|STANDARD_ERROR_OF_MEAN|0.01||0.4888||95.0|-0.026|0.013|||ANCOVA|||||0.013|-0.026|0.4888
72378737|NCT00400153|144265679|NON_INFERIORITY_OR_EQUIVALENCE|This analysis is purely exploratory. Non-inferiority margin is not established for this comparison.|Mean Difference (Final Values)|-0.014||||0.1433||95.0|-0.033|0.005|||ANCOVA|||||0.005|-0.033|0.1433
72378738|NCT00400153|144265680|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.061|STANDARD_ERROR_OF_MEAN|0.011|<|0.0001||95.0|0.04|0.083|||ANCOVA|||This analysis is purely exploratory.||0.083|0.04|< 0.0001
72378739|NCT00400153|144265681|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.044|STANDARD_ERROR_OF_MEAN|0.01|<|0.0001||95.0|0.024|0.065|||ANCOVA|||This analysis is purely exploratory.||0.065|0.024|< 0.0001
72378740|NCT00400153|144265682|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.047|STANDARD_ERROR_OF_MEAN|0.01|<|0.0001||95.0|0.027|0.067|||ANCOVA|||This analysis is purely exploratory.||0.067|0.027|< 0.0001
72378741|NCT00400153|144265683|NON_INFERIORITY_OR_EQUIVALENCE|This analysis is purely exploratory. Non-inferiority margin is not established.|Mean Difference (Final Values)|0.026|STANDARD_ERROR_OF_MEAN|0.012||0.0258||95.0|0.003|0.049|||ANCOVA|||||0.049|0.003|0.0258
72378742|NCT00400153|144265684|NON_INFERIORITY_OR_EQUIVALENCE|This analysis is purely exploratory. Non-inferiority margin is not established.|Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.011||0.3749||95.0|-0.032|0.012|||ANCOVA|||||0.012|-0.032|0.3749
72378743|NCT00400153|144265685|NON_INFERIORITY_OR_EQUIVALENCE|This analysis is purely exploratory. Non-inferiority margin is not established.|Mean Difference (Final Values)|-0.011|STANDARD_ERROR_OF_MEAN|0.011||0.3355||95.0|-0.033|0.011|||ANCOVA|||||0.011|-0.033|0.3355
72378744|NCT00400153|144265686|NON_INFERIORITY_OR_EQUIVALENCE|This analysis is purely exploratory. Non-inferiority margin is not established.|Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.011||0.0743||95.0|-0.042|0.002|||ANCOVA|||||0.002|-0.042|0.0743
72378745|NCT00400153|144265687|NON_INFERIORITY_OR_EQUIVALENCE|This analysis is purely exploratory. Non-inferiority margin is not established.|Mean Difference (Final Values)|0.006|STANDARD_ERROR_OF_MEAN|0.011||0.5711||95.0|-0.015|0.028|||ANCOVA|||||0.028|-0.015|0.5711
72378746|NCT00400153|144265688|NON_INFERIORITY_OR_EQUIVALENCE|This analysis is purely exploratory. Non-inferiority margin is not established.|Mean Difference (Final Values)|-0.013|STANDARD_ERROR_OF_MEAN|0.011||0.2274||95.0|-0.033|0.008|||ANCOVA|||||0.008|-0.033|0.2274
72378747|NCT00400153|144265689|NON_INFERIORITY_OR_EQUIVALENCE|This analysis is purely exploratory. Non-inferiority margin is not established.|Mean Difference (Final Values)|0.003|STANDARD_ERROR_OF_MEAN|0.011||0.8065||95.0|-0.018|0.024|||ANCOVA|||||0.024|-0.018|0.8065
72378748|NCT00400153|144265690|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.065|STANDARD_ERROR_OF_MEAN|0.011|<|0.0001||95.0|0.043|0.087|||ANCOVA|||This analysis is purely exploratory.||0.087|0.043|< 0.0001
72378749|NCT00400153|144265691|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.065|STANDARD_ERROR_OF_MEAN|0.011|<|0.0001||95.0|0.044|0.087|||ANCOVA|||This analysis is purely exploratory.||0.087|0.044|< 0.0001
72378750|NCT00400153|144265692|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.06|STANDARD_ERROR_OF_MEAN|0.011|<|0.0001||95.0|0.04|0.081|||ANCOVA|||This analysis is purely exploratory.||0.081|0.04|< 0.0001
72378751|NCT00400153|144265693|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.068|STANDARD_ERROR_OF_MEAN|0.011|<|0.0001||95.0|0.047|0.089|||ANCOVA|||This analysis is purely exploratory.||0.089|0.047|< 0.0001
72378752|NCT00400153|144265706|NON_INFERIORITY_OR_EQUIVALENCE|This analysis is purely exploratory. Non-inferiority margin is not established.|Mean Difference (Final Values)|-0.017|STANDARD_ERROR_OF_MEAN|0.021||0.417||95.0|-0.058|0.024|||ANCOVA|||||0.024|-0.058|0.417
72378753|NCT00400153|144265707|NON_INFERIORITY_OR_EQUIVALENCE|This analysis is purely exploratory. Non-inferiority margin is not established.|Mean Difference (Final Values)|-0.019|STANDARD_ERROR_OF_MEAN|0.02||0.3505||95.0|-0.059|0.021|||ANCOVA|||||0.021|-0.059|0.3505
72378754|NCT00400153|144265708|NON_INFERIORITY_OR_EQUIVALENCE|This analysis is purely exploratory. Non-inferiority margin is not established.|Mean Difference (Final Values)|-0.019|STANDARD_ERROR_OF_MEAN|0.02||0.3499||95.0|-0.058|0.021|||ANCOVA|||||0.021|-0.058|0.3499
72378755|NCT00400153|144265709|NON_INFERIORITY_OR_EQUIVALENCE|This analysis is purely exploratory. Non-inferiority margin is not established.|Mean Difference (Final Values)|-0.004|STANDARD_ERROR_OF_MEAN|0.02||0.8288||95.0|-0.044|0.035|||ANCOVA|||||0.035|-0.044|0.8288
72378756|NCT00400153|144265710|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.112|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001||95.0|0.069|0.154|||ANCOVA|||This analysis is purely exploratory.||0.154|0.069|< 0.0001
72378757|NCT00400153|144265711|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.09|STANDARD_ERROR_OF_MEAN|0.021|<|0.0001||95.0|0.049|0.132|||ANCOVA|||This analysis is purely exploratory.||0.132|0.049|< 0.0001
72378758|NCT00400153|144265712|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.097|STANDARD_ERROR_OF_MEAN|0.021|<|0.0001||95.0|0.056|0.138|||ANCOVA|||This analysis is purely exploratory.||0.138|0.056|< 0.0001
72378759|NCT00400153|144265713|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.094|STANDARD_ERROR_OF_MEAN|0.021|<|0.0001||95.0|0.054|0.135|||ANCOVA|||This analysis is purely exploratory.||0.135|0.054|< 0.0001
72378760|NCT00400153|144265714|NON_INFERIORITY_OR_EQUIVALENCE|This analysis is purely exploratory. Non-inferiority margin is not established.|Mean Difference (Final Values)|0.043|STANDARD_ERROR_OF_MEAN|0.024||0.0688||95.0|-0.003|0.09|||ANCOVA|||||0.09|-0.003|0.0688
72378761|NCT00400153|144265715|NON_INFERIORITY_OR_EQUIVALENCE|This analysis is purely exploratory. Non-inferiority margin is not established.|Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.023||0.3895||95.0|-0.064|0.025|||ANCOVA|||||0.025|-0.064|0.3895
72378762|NCT00400153|144265716|NON_INFERIORITY_OR_EQUIVALENCE|This analysis is purely exploratory. Non-inferiority margin is not established.|Mean Difference (Final Values)|-0.001|STANDARD_ERROR_OF_MEAN|0.022||0.959||95.0|-0.045|0.042|||ANCOVA|||||0.042|-0.045|0.959
72433610|NCT00991276|144380371|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-25.84|STANDARD_ERROR_OF_MEAN|2.86|<|0.0001|TWO_SIDED|95.0|-31.51|-20.17||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||-20.17|-31.51|<0.0001
72433611|NCT00991276|144380372|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-14.53|STANDARD_ERROR_OF_MEAN|3.19|<|0.0001|TWO_SIDED|95.0|-20.84|-8.22||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||-8.22|-20.84|<0.0001
72433612|NCT00991276|144380372|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|14.42|STANDARD_ERROR_OF_MEAN|3.15|<|0.0001|TWO_SIDED|95.0|8.18|20.67||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||20.67|8.18|<0.0001
72378763|NCT00400153|144265717|NON_INFERIORITY_OR_EQUIVALENCE|This analysis is purely exploratory. Non-inferiority margin is not established.|Mean Difference (Final Values)|-0.007|STANDARD_ERROR_OF_MEAN|0.023||0.7652||95.0|-0.053|0.039|||ANCOVA|||||0.039|-0.053|0.7652
72378764|NCT00400153|144265718|NON_INFERIORITY_OR_EQUIVALENCE|This analysis is purely exploratory. Non-inferiority margin is not established.|Mean Difference (Final Values)|-0.011|STANDARD_ERROR_OF_MEAN|0.023||0.6244||95.0|-0.057|0.034|||ANCOVA|||||0.034|-0.057|0.6244
72378765|NCT00400153|144265719|NON_INFERIORITY_OR_EQUIVALENCE|This analysis is purely exploratory. Non-inferiority margin is not established.|Mean Difference (Final Values)|0.004|STANDARD_ERROR_OF_MEAN|0.023||0.873||95.0|-0.041|0.049|||ANCOVA|||||0.049|-0.041|0.873
72378766|NCT00400153|144265720|NON_INFERIORITY_OR_EQUIVALENCE|This analysis is purely exploratory. Non-inferiority margin is not established.|Mean Difference (Final Values)|-0.015|STANDARD_ERROR_OF_MEAN|0.023||0.5294||95.0|-0.06|0.031|||ANCOVA|||||0.031|-0.06|0.5294
72378767|NCT00400153|144265721|NON_INFERIORITY_OR_EQUIVALENCE|This analysis is purely exploratory. Non-inferiority margin is not established.|Mean Difference (Final Values)|0.013|STANDARD_ERROR_OF_MEAN|0.023||0.563||95.0|-0.032|0.058|||ANCOVA|||||0.058|-0.032|0.563
72378768|NCT00400153|144265722|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.121|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001||95.0|0.075|0.167|||ANCOVA|||This analysis is purely exploratory.||0.167|0.075|< 0.0001
72378769|NCT00400153|144265723|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.129|STANDARD_ERROR_OF_MEAN|0.023|<|0.0001||95.0|0.084|0.174|||ANCOVA|||This analysis is purely exploratory.||0.174|0.084|< 0.0001
72378770|NCT00400153|144265724|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.118|STANDARD_ERROR_OF_MEAN|0.023|<|0.0001||95.0|0.072|0.163|||ANCOVA|||This analysis is purely exploratory.||0.163|0.072|< 0.0001
72378771|NCT00400153|144265725|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.126|STANDARD_ERROR_OF_MEAN|0.023|<|0.0001||95.0|0.081|0.171|||ANCOVA|||This analysis is purely exploratory.||0.171|0.081|< 0.0001
72378772|NCT00400153|144265730|NON_INFERIORITY_OR_EQUIVALENCE|This analysis is purely exploratory. Non-inferiority margin is not established.|Mean Difference (Final Values)|-0.00045|STANDARD_ERROR_OF_MEAN|0.06396||0.9943||95.0|-0.1259|0.125|||ANCOVA|||||0.125|-0.1259|0.9943
72378773|NCT00400153|144265730|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01995|STANDARD_ERROR_OF_MEAN|0.06441||0.7569|TWO_SIDED|95.0|-0.1463|0.1064|||ANCOVA|||This analysis is purely exploratory.||0.1064|-0.1463|0.7569
72378774|NCT00400153|144265731|NON_INFERIORITY_OR_EQUIVALENCE|This analysis is purely exploratory. Non-inferiority margin is not established.|Mean Difference (Final Values)|0.1091|STANDARD_ERROR_OF_MEAN|0.1206||0.3659||95.0|-0.1276|0.3458|||ANCOVA|||||0.3458|-0.1276|0.3659
72378775|NCT00400153|144265731|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1554|STANDARD_ERROR_OF_MEAN|0.122||0.203|TWO_SIDED|95.0|-0.3947|0.08395|||ANCOVA|||This analysis is purely exploratory.||0.08395|-0.3947|0.203
72378776|NCT00400153|144265732|NON_INFERIORITY_OR_EQUIVALENCE|This analysis is purely exploratory. Non-inferiority margin is not established.|Mean Difference (Final Values)|0.007734|STANDARD_ERROR_OF_MEAN|0.03199||0.809||95.0|-0.05503|0.0705|||ANCOVA|||||0.0705|-0.05503|0.809
72378777|NCT00400153|144265732|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.06501|STANDARD_ERROR_OF_MEAN|0.03225||0.044|TWO_SIDED|95.0|0.001746|0.1283|||ANCOVA|||This analysis is purely exploratory.||0.1283|0.001746|0.044
72378778|NCT00400153|144265733|NON_INFERIORITY_OR_EQUIVALENCE|This analysis is purely exploratory. Non-inferiority margin is not established.|Mean Difference (Final Values)|0.0129|STANDARD_ERROR_OF_MEAN|0.03002||0.6674||95.0|-0.04598|0.07179|||ANCOVA|||||0.07179|-0.04598|0.6674
72378779|NCT00400153|144265733|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01573|STANDARD_ERROR_OF_MEAN|0.03033||0.604|TWO_SIDED|95.0|-0.04376|0.07523|||ANCOVA|||This analysis is purely exploratory.||0.07523|-0.04376|0.604
72378780|NCT00400153|144265734|NON_INFERIORITY_OR_EQUIVALENCE|This analysis is purely exploratory. Non-inferiority margin is not established.|Mean Difference (Final Values)|1.6526|STANDARD_ERROR_OF_MEAN|2.0653||0.4238||95.0|-2.3995|5.7047|||ANCOVA|||||5.7047|-2.3995|0.4238
72378781|NCT00400153|144265734|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.4376|STANDARD_ERROR_OF_MEAN|2.0874||0.2431|TWO_SIDED|95.0|-1.6578|6.533|||ANCOVA|||This analysis is purely exploratory.||6.533|-1.6578|0.2431
72378782|NCT00400153|144265735|NON_INFERIORITY_OR_EQUIVALENCE|This analysis is purely exploratory. Non-inferiority margin is not established.|Mean Difference (Final Values)|0.077|STANDARD_ERROR_OF_MEAN|0.056||0.173||95.0|-0.034|0.187|||ANCOVA|||||0.187|-0.034|0.173
72378783|NCT00400153|144265735|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.054|STANDARD_ERROR_OF_MEAN|0.056||0.336|TWO_SIDED|95.0|-0.165|0.056|||ANCOVA|||This analysis is purely exploratory.||0.056|-0.165|0.336
72378784|NCT00400153|144265736|NON_INFERIORITY_OR_EQUIVALENCE|This analysis is purely exploratory. Non-inferiority margin is not established.|Mean Difference (Final Values)|0.006|STANDARD_ERROR_OF_MEAN|0.062||0.924||95.0|-0.115|0.127|||ANCOVA|||||0.127|-0.115|0.924
72556316|NCT00862563|144643980|SUPERIORITY_OR_OTHER||Difference between least squares means|-20.9|STANDARD_ERROR_OF_MEAN|9.8||0.036|TWO_SIDED|||||p\<0.05 is considered to be significant|ANOVA|||Comparison of Week 11 means for mean percent heavy drinking days obtained for the placebo and zonisamide groups Means used for the analysis are least squares means from a two-way repeated measures mixed models analysis, with Week (time) as the the within subject factor and treatment as the between group factor. Baseline values were used as covariates.||||0.036
72378785|NCT00400153|144265736|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.069|STANDARD_ERROR_OF_MEAN|0.062||0.266|TWO_SIDED|95.0|-0.19|0.053|||ANCOVA|||This analysis is purely exploratory.||0.053|-0.19|0.266
72378786|NCT00400153|144265737|NON_INFERIORITY_OR_EQUIVALENCE|This analysis is purely exploratory. Non-inferiority margin is not established.|Mean Difference (Final Values)|0.097|STANDARD_ERROR_OF_MEAN|0.065||0.139||95.0|-0.031|0.225|||ANCOVA|||||0.225|-0.031|0.139
72556317|NCT00862563|144643980|SUPERIORITY_OR_OTHER||Difference between least squares means|-22.8|STANDARD_ERROR_OF_MEAN|9.9||0.24|TWO_SIDED|||||p\< 0.05 is considered to be significant|ANOVA|||Comparison of Week 12 means for mean percent heavy drinking days obtained for the placebo and zonisamide groups Means used for the analysis are least squares means from a two-way repeated measures mixed models analysis, with Week (time) as the the within subject factor and treatment as the between group factor. Baseline values were used as covariates.||||0.24
72378787|NCT00400153|144265737|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.018|STANDARD_ERROR_OF_MEAN|0.066||0.788|TWO_SIDED|95.0|-0.111|0.146|||ANCOVA|||This analysis is purely exploratory.||0.146|-0.111|0.788
72378788|NCT00400153|144265742|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.398|STANDARD_ERROR_OF_MEAN|0.065|<|0.0001||95.0|||||ANOVA|||Difference: Respimat - MDI||||< 0.0001
72378789|NCT00400153|144265743|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.482|STANDARD_ERROR_OF_MEAN|0.065|<|0.0001||95.0|||||ANOVA|||Difference: Respimat - MDI||||<0.0001
72378790|NCT00400153|144265744|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.612|STANDARD_ERROR_OF_MEAN|0.075|<|0.0001||95.0|||||ANOVA|||Difference: Respimat - MDI||||<0.0001
72378791|NCT00400153|144265745|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.508|STANDARD_ERROR_OF_MEAN|0.058|<|0.0001||95.0|||||ANOVA|||Difference: Respimat - MDI||||<0.0001
72378792|NCT00400153|144265746|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.421|STANDARD_ERROR_OF_MEAN|0.061|<|0.0001||95.0|||||ANOVA|||Difference: Respimat - MDI||||< 0.0001
72378793|NCT00400153|144265747|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.226|STANDARD_ERROR_OF_MEAN|0.047|<|0.0001||95.0|||||ANOVA|||Difference: Respimat - MDI||||< 0.0001
72378794|NCT00400153|144265748|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.265|STANDARD_ERROR_OF_MEAN|0.05|<|0.0001||95.0|||||ANOVA|||Difference: Respimat - MDI||||< 0.0001
72378795|NCT00400153|144265749|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.378|STANDARD_ERROR_OF_MEAN|0.06|<|0.0001||95.0|||||ANOVA|||Difference: Respimat - MDI||||< 0.0001
72378796|NCT00400153|144265750|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.402|STANDARD_ERROR_OF_MEAN|0.062|<|0.0001||95.0|||||ANOVA|||Difference: Respimat - MDI||||< 0.0001
72378797|NCT00400153|144265751|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.464|STANDARD_ERROR_OF_MEAN|0.063|<|0.0001||95.0|||||ANOVA|||Difference: Respimat - MDI||||< 0.0001
72378798|NCT01150474|144265772|SUPERIORITY_OR_OTHER|||||||0.82|TWO_SIDED||||||t-test, 2 sided|||||||0.82
72556318|NCT00862563|144643980|SUPERIORITY_OR_OTHER||Difference between least squares means|-33.0|STANDARD_ERROR_OF_MEAN|9.0||0.0004|TWO_SIDED|||||p\<0.05 is considered to be significant.|ANOVA|||Comparison of Week 10 means for mean percent heavy drinking days obtained for the placebo and topiramate groups Means used for the analysis are least squares means from a two-way repeated measures mixed models analysis, with Week (time) as the the within subject factor and treatment as the between group factor. Baseline values were used as covariates.||||0.0004
72618507|NCT01026038|144768103|SUPERIORITY_OR_OTHER||GMC ratio|0.85|||||TWO_SIDED|95.0|0.65|1.11||||||Serotype 18C: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.11|0.65|
72378799|NCT01150474|144265773|SUPERIORITY_OR_OTHER|||||||0.75|TWO_SIDED||||||t-test, 2 sided|||||||0.75
72378800|NCT01150474|144265774|SUPERIORITY_OR_OTHER|||||||0.07|TWO_SIDED||||||t-test, 2 sided|||||||0.07
72378801|NCT01150474|144265775|SUPERIORITY_OR_OTHER|||||||0.43|TWO_SIDED||||||t-test, 2 sided|||||||0.43
72378802|NCT01150474|144265776|SUPERIORITY_OR_OTHER|||||||0.3|TWO_SIDED||||||t-test, 2 sided|||||||0.30
72378803|NCT01150474|144265777|SUPERIORITY_OR_OTHER|||||||0.14|TWO_SIDED||||||t-test, 2 sided|||||||0.14
72378804|NCT01150474|144265778|SUPERIORITY_OR_OTHER|||||||0.83|TWO_SIDED||||||t-test, 2 sided|||||||0.83
72378805|NCT01150474|144265779|SUPERIORITY_OR_OTHER|||||||0.55|TWO_SIDED||||||t-test, 2 sided|||||||0.55
72378806|NCT01150474|144265780|SUPERIORITY_OR_OTHER|||||||0.59|TWO_SIDED||||||t-test, 2 sided|||||||0.59
72378807|NCT01423604|144265781|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.733||||0.0494|TWO_SIDED|95.0|0.506|1.061||One-sided p-value.|Log Rank|||||1.061|0.506|0.0494
72433613|NCT00991276|144380372|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-28.95|STANDARD_ERROR_OF_MEAN|3.14|<|0.0001|TWO_SIDED|95.0|-35.16|-22.74||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||-22.74|-35.16|<0.0001
72618508|NCT01026038|144768103|SUPERIORITY_OR_OTHER||GMCratio|1.14|||||TWO_SIDED|95.0|0.84|1.56||||||Serotype 18C: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.56|0.84|
72378808|NCT01423604|144265781|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.502||||0.0081|TWO_SIDED|95.0|0.281|0.888||One-sided p-value.|Log Rank|||Cox Regression Analysis of Overall Survival: C-reactive protein (CRP) \> 13 μg/ml; Statistical analysis plan (SAP) specified subgroup analysis||0.888|0.281|0.0081
72378809|NCT01423604|144265782|SUPERIORITY_OR_OTHER||Efron approximation of hazard ratio|0.75||||0.134|TWO_SIDED|95.0|0.513|1.094||Two-sided p-value.|Cox proportional hazards model|||||1.094|0.513|0.1340
72378810|NCT01423604|144265784|SUPERIORITY_OR_OTHER|||||||0.0236|||||||Pearson's chi-square test|||||||0.0236
72378811|NCT00424255|144265786|SUPERIORITY_OR_OTHER|||||||0.2251||95.0||||The one-sided p-value is unstratified as there are too few events per stratum to perform a stratified test.|Non-stratified log-rank test|||||||0.2251
72378812|NCT00424255|144265786|SUPERIORITY_OR_OTHER|||||||0.4502||95.0||||The two-sided p-value is unstratified as there are too few events per stratum to perform a stratified test.|Non-stratified log-rank test|||||||0.4502
72378813|NCT00424255|144265786|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.1|||||TWO_SIDED|95.0|0.85|1.43|||||Hazard Ratios were estimated using a Pike estimator.|||1.43|0.85|
72378814|NCT02290431|144265810|SUPERIORITY||||||<|0.0001|||||||single-sample binomial test|||||||< 0.0001
72378815|NCT00219544|144265838|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.78|STANDARD_ERROR_OF_MEAN|0.25||0.0018||95.0|-1.27|-0.3|||ANCOVA||Difference = pregabalin minus placebo|The study is powered to detect clinically significant difference of 1.2 between treatment groups in mean pain score at end of treatment. The statistical sample size calculation requires a total of 144 subjects to complete the Double-Blind phase of the study: a sample size of 72 in each treatment group will have 90% power to detect a difference in treatment mean pain scores of 1.2 assuming that the common standard deviation is 2.2 using a two group t-test with a 0.05 two-sided significance level.||-0.30|-1.27|0.0018
72378816|NCT00219544|144265841|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.72|STANDARD_ERROR_OF_MEAN|0.22||0.001||95.0|-1.15|-0.3|||ANCOVA||pregabalin minus placebo|Week 5||-0.30|-1.15|0.0010
72378817|NCT00219544|144265841|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.97|STANDARD_ERROR_OF_MEAN|0.22|<|0.0001||95.0|-1.41|-0.53|||ANCOVA||pregabalin minus placebo|Week 6||-0.53|-1.41|<.0001
72378818|NCT00219544|144265841|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.93|STANDARD_ERROR_OF_MEAN|0.23|<|0.0001||95.0|-1.39|-0.47|||ANCOVA||pregabalin minus placebo|Week 7||-0.47|-1.39|<.0001
72378819|NCT00219544|144265841|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.93|STANDARD_ERROR_OF_MEAN|0.23|<|0.0001||95.0|-1.39|-0.47|||ANCOVA||pregabalin minus placebo|Week 8||-0.47|-1.39|<.0001
72378820|NCT00219544|144265841|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.69|STANDARD_ERROR_OF_MEAN|0.23||0.0022||95.0|-1.14|-0.25|||ANCOVA||pregabalin minus placebo|Week 9||-0.25|-1.14|0.0022
72378821|NCT00219544|144265847|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Net)|-0.71|STANDARD_ERROR_OF_MEAN|0.24||0.0031||95.0|-1.18|-0.24|||ANCOVA|||||-0.24|-1.18|0.0031
72378822|NCT00219544|144265850|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.52|STANDARD_ERROR_OF_MEAN|0.22||0.0177||95.0|-0.94|-0.09|||ANCOVA||pregabalin minus placebo|Week 5||-0.09|-0.94|0.0177
72378823|NCT00219544|144265850|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.87|STANDARD_ERROR_OF_MEAN|0.22|<|0.0001||95.0|-1.31|-0.44|||ANCOVA||pregabalin minus placebo|Week 6||-0.44|-1.31|<.0001
72378824|NCT00219544|144265850|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.82|STANDARD_ERROR_OF_MEAN|0.23||0.0005||95.0|-1.28|-0.36|||ANCOVA||pregabalin minus placebo|Week 7||-0.36|-1.28|0.0005
72378825|NCT00219544|144265850|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.85|STANDARD_ERROR_OF_MEAN|0.23||0.0003||95.0|-1.31|-0.39|||ANCOVA||pregabalin minus placebo|Week 8||-0.39|-1.31|0.0003
72378826|NCT00219544|144265850|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.74|STANDARD_ERROR_OF_MEAN|0.22||0.0011||95.0|-1.18|-0.3|||ANCOVA||pregabalin minus placebo|Week 9||-0.30|-1.18|0.0011
72618509|NCT01026038|144768103|SUPERIORITY_OR_OTHER||GMC ratio|1.37|||||TWO_SIDED|95.0|0.97|1.94||||||Serotype 19F: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||1.94|0.97|
72378827|NCT00219544|144265851|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-9.0|STANDARD_ERROR_OF_MEAN|3.3||0.0069||95.0|-15.5|-2.5|||ANCOVA|||||-2.5|-15.5|0.0069
72378828|NCT00219544|144265852|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-1.3|STANDARD_ERROR_OF_MEAN|0.4||0.0023||95.0|-2.1|-0.5|||ANCOVA||pregabalin minus placebo|HADS-A||-0.5|-2.1|0.0023
72378829|NCT00219544|144265852|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-1.2|STANDARD_ERROR_OF_MEAN|0.4||0.0013||95.0|-1.9|-0.5|||ANCOVA||pregabalin minus placebo|HADS-D||-0.5|-1.9|0.0013
72378830|NCT00219544|144265853|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|5.98|STANDARD_ERROR_OF_MEAN|3.42||0.0828||95.0|-0.79|12.75|||ANCOVA||pregabalin minus placebo|Impact||12.75|-0.79|0.0828
72378831|NCT00219544|144265853|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|6.49|STANDARD_ERROR_OF_MEAN|2.75||0.0197||95.0|1.05|11.94|||ANCOVA||pregabalin minus placebo|Satisfaction||11.94|1.05|0.0197
72378832|NCT00219544|144265854|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0278||95.0|||||Mantel Haenszel|||The distribution of the responses to the PGIC at EOT was compared between the 2 treatment groups using the 7 categories of the PGIC.||||0.0278
72378833|NCT00219544|144265855|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.76|STANDARD_ERROR_OF_MEAN|0.26||0.0049||95.0|-1.28|-0.23|||ANCOVA|||Pain interference||-0.23|-1.28|0.0049
72378834|NCT00219544|144265855|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.77|STANDARD_ERROR_OF_MEAN|0.26||0.0037||95.0|-1.29|-0.25|||ANCOVA|||Pain severity||-0.25|-1.29|0.0037
72378835|NCT00219544|144265856|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.05|STANDARD_ERROR_OF_MEAN|0.03||0.0719||95.0|0.0|0.11|||ANCOVA||pregabalin minus placebo|Health State Profile||0.11|-0.00|0.0719
72378836|NCT00219544|144265856|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|2.07|STANDARD_ERROR_OF_MEAN|2.54||0.418||95.0|-2.96|7.1|||ANCOVA||pregabalin minus placebo|Visual Analog Scale||7.10|-2.96|0.4180
72378837|NCT01007253|144265860|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Friedman ANOVA|||Analysis of variance (ANOVA) was used to test the null hypothesis of no mean eye symptoms score difference among the four treatment groups.||||<0.001
72378838|NCT01007253|144265861|SUPERIORITY_OR_OTHER|||||||0.05|||||||Friedman ANOVA|||Analysis of variance (ANOVA) was used to test the null hypothesis of no mean nasal symptoms score difference among the four treatment groups.||||0.05
72618510|NCT01026038|144768103|SUPERIORITY_OR_OTHER||GMC ratio|1.1|||||TWO_SIDED|95.0|0.78|1.55||||||Serotype 19F: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.55|0.78|
72378839|NCT01007253|144265862|SUPERIORITY_OR_OTHER|||||||0.001|||||||Friedman ANOVA|||Analysis of variance (ANOVA) was used to test the null hypothesis of no mean sneeze difference among the four treatment groups.||||0.001
72378840|NCT01007253|144265863|SUPERIORITY_OR_OTHER|||||||0.11|||||||Friedman ANOVA|||Analysis of variance (ANOVA) was used to test the null hypothesis of no mean histamine level difference among the four treatment groups.||||0.11
72378841|NCT01007253|144265864|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Friedman ANOVA|||Analysis of variance (ANOVA) was used to test the null hypothesis of no mean tryptase level difference among the four treatment groups.||||<0.001
72378842|NCT00814801|144265866|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.49||||0.0113|TWO_SIDED|95.0|-2.64|-0.34|||Least Square Means|||||-0.34|-2.64|0.0113
72378843|NCT00814801|144265866|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.59|||<|0.0001|TWO_SIDED|95.0|-3.74|-1.44|||Least Square Means|||||-1.44|-3.74|<0.0001
72378844|NCT00814801|144265868|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.8||||0.0774|TWO_SIDED|95.0|-0.2|3.7|||Least Square Means|||||3.7|-0.2|0.0774
72378845|NCT00814801|144265868|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.5||||0.6207|TWO_SIDED|95.0|-1.5|2.4|||Least Square Means|||||2.4|-1.5|0.6207
72378846|NCT00814801|144265869|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||0.8419|TWO_SIDED|95.0|-0.6|0.8|||Least Square Means|||||0.8|-0.6|0.8419
72378847|NCT00814801|144265869|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.7942|TWO_SIDED|95.0|-0.8|0.6|||Least Square Means|||||0.6|-0.8|0.7942
72378848|NCT00814801|144265870|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5||||0.3141|TWO_SIDED|95.0|-1.6|0.5|||Least Square Means|||||0.5|-1.6|0.3141
72378849|NCT00814801|144265870|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3||||0.6089|TWO_SIDED|95.0|-1.3|0.8|||Least Square Means|||||0.8|-1.3|0.6089
72378850|NCT02751931|144265884|OTHER||Mean Difference (Net)|72.09|||<|0.001|TWO_SIDED|95.0|45.28|98.89||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 24 - Children||98.89|45.28|<0.001
72378851|NCT02751931|144265884|OTHER||Mean Difference (Net)|113.21|||<|0.001|TWO_SIDED|95.0|78.95|147.47||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 24 - Adolescents||147.47|78.95|<0.001
72378852|NCT02751931|144265885|OTHER||Mean Difference (Net)|-4.09||||0.618|TWO_SIDED|95.0|-20.55|12.38||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 4 - Children||12.38|-20.55|0.618
72378853|NCT02751931|144265885|OTHER||Mean Difference (Net)|15.16||||0.005|TWO_SIDED|95.0|5.1|25.22||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 4 - Adolescents||25.22|5.10|0.005
72378854|NCT02751931|144265885|OTHER||Mean Difference (Net)|14.62||||0.055|TWO_SIDED|95.0|-0.31|29.54||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 24 - Children||29.54|-0.31|0.055
72378855|NCT02751931|144265885|OTHER||Mean Difference (Net)|13.59|||<|0.001|TWO_SIDED|95.0|6.75|20.42||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 24 - Adolescents||20.42|6.75|<0.001
72378856|NCT02751931|144265886|OTHER||Mean Difference (Net)|41.36|||<|0.001|TWO_SIDED|95.0|18.75|63.97||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change from Baseline at week 4 - Children.||63.97|18.75|<0.001
72378857|NCT02751931|144265886|OTHER||Mean Difference (Net)|80.78|||<|0.001|TWO_SIDED|95.0|39.2|122.36||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 4 - Adolescents||122.36|39.20|<0.001
72378858|NCT02751931|144265887|OTHER||Mean Difference (Net)|0.44||||0.632|TWO_SIDED|95.0|-1.4|2.28||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 4 - Children||2.28|-1.40|0.632
72378859|NCT02751931|144265887|OTHER||Mean Difference (Net)|-0.64||||0.321|TWO_SIDED|95.0|-1.94|0.67|||t-test, 2 sided|||Change From Baseline at Week 4 - Adolescents||0.67|-1.94|0.321
72378860|NCT02751931|144265887|OTHER||Mean Difference (Net)|-1.86||||0.011|TWO_SIDED|95.0|-3.27|-0.45||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 24 - Children||-0.45|-3.27|0.011
72378861|NCT02751931|144265887|OTHER||Mean Difference (Net)|-0.77||||0.359|TWO_SIDED|95.0|-2.49|0.94||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 24 - Adolescents||0.94|-2.49|0.359
72378862|NCT02751931|144265888|OTHER||Mean Difference (Net)|-12.38|||<|0.001|TWO_SIDED|95.0|-18.56|-6.21||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 4 - Children||-6.21|-18.56|<0.001
72378863|NCT02751931|144265888|OTHER||Mean Difference (Net)|-6.48||||0.334|TWO_SIDED|95.0|-20.09|7.13||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 4 - Adolescents||7.13|-20.09|0.334
72378864|NCT02751931|144265888|OTHER||Mean Difference (Net)|-18.11|||<|0.001|TWO_SIDED|95.0|-24.87|-11.35||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 24 - Children||-11.35|-24.87|<0.001
72378865|NCT02751931|144265888|OTHER||Mean Difference (Net)|-13.19||||0.005||95.0|-22.02|-4.36||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 24 - Adolescents||-4.36|-22.02|0.005
72378866|NCT02751931|144265889|OTHER||||||<|0.001||||||From a Wilcoxon signed-rank test, testing the null hypothesis that week 4 median is equal to baseline median.|Wilcoxon signed-rank test|||Change From Baseline at Week 4 - Children||||<0.001
72378867|NCT02751931|144265889|OTHER|||||||0.148||||||From a Wilcoxon signed-rank test, testing the null hypothesis that week 4 median is equal to baseline median.|Wilcoxon signed-rank test|||Change From Baseline at Week 4 - Adolescents||||0.148
72378868|NCT02751931|144265889|OTHER|||||||0.002||||||From a Wilcoxon signed-rank test, testing the null hypothesis that week 24 median is equal to baseline median.|Wilcoxon signed-rank test|||Change From Baseline at Week 24 - Children||||0.002
72378869|NCT02751931|144265889|OTHER|||||||0.039||||||From a Wilcoxon signed-rank test, testing the null hypothesis that week 24 median is equal to baseline median.|Wilcoxon signed-rank test|||Change From Baseline at Week 24 - Adolescents||||0.039
72378870|NCT02751931|144265890|OTHER||||||<|0.001||||||From a Wilcoxon signed-rank test, testing the null hypothesis that week 4 median is equal to baseline median.|Wilcoxon signed-rank test|||Change From Baseline at Week 4 - Children||||<0.001
72378871|NCT02751931|144265890|OTHER|||||||0.007||||||From a Wilcoxon signed-rank test, testing the null hypothesis that week 4 median is equal to baseline median.|Wilcoxon signed-rank test|||Change From Baseline at Week 4 - Adolescents||||0.007
72378872|NCT02751931|144265890|OTHER||||||<|0.001||||||From a Wilcoxon signed-rank test, testing the null hypothesis that week 24 median is equal to baseline median.|Wilcoxon signed-rank test|||Change From Baseline at Week 24 - Children||||< 0.001
72378873|NCT02751931|144265890|OTHER||||||<|0.001||||||From a Wilcoxon signed-rank test, testing the null hypothesis that week 24 median is equal to baseline median.|Wilcoxon signed-rank test|||Change From Baseline at Week 24 - Adolescents||||< 0.001
72378874|NCT02751931|144265891|OTHER||||||<|0.001||||||From a 2-sided paired t-test, testing the null hypothesis that change from baseline was equal to 0.|t-test, 2 sided|||Change From Baseline at Week 4 - Children||||<0.001
72378875|NCT02751931|144265891|OTHER|||||||0.006||||||From a 2-sided paired t-test, testing the null hypothesis that change from baseline was equal to 0.|t-test, 2 sided|||Change From Baseline at Week 4 - Adolescents||||0.006
72378876|NCT02751931|144265891|OTHER||||||<|0.001||||||From a 2-sided paired t-test, testing the null hypothesis that change from baseline was equal to 0.|t-test, 2 sided|||Change From Baseline at Week 24 - Children||||< 0.001
72378877|NCT02751931|144265891|OTHER|||||||0.001||||||From a 2-sided paired t-test, testing the null hypothesis that change from baseline was equal to 0.|t-test, 2 sided|||Change From Baseline at Week 24 - Adolescents||||0.001
72378878|NCT02751931|144265892|OTHER||Mean Difference (Net)|14.58||||0.035|TWO_SIDED|95.0|1.0|28.1||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 2 - Children||28.1|1.0|0.035
72378879|NCT02751931|144265892|OTHER||Mean Difference (Net)|35.99||||0.003|TWO_SIDED|95.0|13.1|58.9||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 2 - Adolescents||58.9|13.1|0.003
72378880|NCT02751931|144265892|OTHER||Mean Difference (Net)|30.08|||<|0.001|TWO_SIDED|95.0|14.7|45.5||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 4 - Children||45.5|14.7|<0.001
72378881|NCT02751931|144265892|OTHER||Mean Difference (Net)|51.96|||<|0.001|TWO_SIDED|95.0|24.6|79.3||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 4 - Adolescents||79.3|24.6|<0.001
72378882|NCT02751931|144265892|OTHER||Mean Difference (Net)|36.9|||<|0.001|TWO_SIDED|95.0|22.7|51.1||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 8 - Children||51.1|22.7|<0.001
72378883|NCT02751931|144265892|OTHER||Mean Difference (Net)|45.1|||<|0.001|TWO_SIDED|95.0|21.3|68.9||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 8 - Adolescents||68.9|21.3|<0.001
72378884|NCT02751931|144265892|OTHER||Mean Difference (Net)|32.25|||<|0.001|TWO_SIDED|95.0|18.2|46.3||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 12 - Children||46.3|18.2|<0.001
72378885|NCT02751931|144265892|OTHER||Mean Difference (Net)|43.94||||0.001|TWO_SIDED|95.0|19.2|68.6||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 12 - Adolescents||68.6|19.2|0.001
72378886|NCT02751931|144265892|OTHER||Mean Difference (Net)|41.63|||<|0.001|TWO_SIDED|95.0|23.3|60.0||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 24 - Children||60.0|23.3|<0.001
72378887|NCT02751931|144265892|OTHER||Mean Difference (Net)|59.31||||0.002|TWO_SIDED|95.0|23.8|94.9||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 24 - Adolescents||94.9|23.8|0.002
72378888|NCT02751931|144265892|OTHER||Mean Difference (Net)|53.87|||<|0.001|TWO_SIDED|95.0|24.5|83.2||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 36 - Children||83.2|24.5|<0.001
72378889|NCT02751931|144265892|OTHER||Mean Difference (Net)|52.14||||0.002|TWO_SIDED|95.0|20.5|83.8||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 36 - Adolescents||83.8|20.5|0.002
72378890|NCT02751931|144265892|OTHER||Mean Difference (Net)|42.84|||<|0.001|TWO_SIDED|95.0|22.0|63.7||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 52 - Children||63.7|22.0|<0.001
72378891|NCT02751931|144265892|OTHER||Mean Difference (Net)|42.4||||0.008|TWO_SIDED|95.0|12.5|72.3||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 52 - Adolescents||72.3|12.5|0.008
72378892|NCT02751931|144265893|OTHER||Mean Difference (Net)|17.5||||0.126|TWO_SIDED|95.0|-5.1|40.1||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 2 - Children||40.1|-5.1|0.126
72378893|NCT02751931|144265893|OTHER||Mean Difference (Net)|42.38||||0.014|TWO_SIDED|95.0|9.3|75.4||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 2 - Adolescents||75.4|9.3|0.014
72378894|NCT02751931|144265893|OTHER||Mean Difference (Net)|46.69|||<|0.001|TWO_SIDED|95.0|21.7|71.7||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 4 - Children||71.7|21.7|<0.001
72378895|NCT02751931|144265893|OTHER||Mean Difference (Net)|73.25||||0.002|TWO_SIDED|95.0|29.3|117.2||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 4 - Adolescents||117.2|29.3|0.002
72433614|NCT00991276|144380373|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-2.86|STANDARD_ERROR_OF_MEAN|0.54|<|0.0001|TWO_SIDED|95.0|-3.93|-1.8||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||-1.80|-3.93|<0.0001
72378896|NCT02751931|144265893|OTHER|Pre-Specified|Mean Difference (Net)|45.27|||<|0.001|TWO_SIDED|95.0|22.1|68.4||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 8 - Children||68.4|22.1|<0.001
72378897|NCT02751931|144265893|OTHER||Mean Difference (Net)|42.86||||0.02|TWO_SIDED|95.0|7.4|78.3||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 8 - Adolescents||78.3|7.4|0.020
72378898|NCT02751931|144265893|OTHER||Mean Difference (Net)|33.23||||0.003|TWO_SIDED|95.0|12.2|54.3||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 12 - Children||54.3|12.2|0.003
72433615|NCT00991276|144380373|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-4.71|STANDARD_ERROR_OF_MEAN|0.53|<|0.0001|TWO_SIDED|95.0|-5.76|-3.65||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||-3.65|-5.76|<0.0001
72618511|NCT01026038|144768103|SUPERIORITY_OR_OTHER||GMC ratio|0.8|||||TWO_SIDED|95.0|0.54|1.19||||||Serotype 19F: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.19|0.54|
72378899|NCT02751931|144265893|OTHER||Mean Difference (Net)|47.29||||0.003|TWO_SIDED|95.0|17.8|76.8||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 12 - Adolescents||76.8|17.8|0.003
72378900|NCT02751931|144265893|OTHER||Mean Difference (Net)|49.88||||0.004|TWO_SIDED|95.0|17.1|82.6||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 24 - Children||82.6|17.1|0.004
72378901|NCT02751931|144265893|OTHER||Mean Difference (Net)|84.39||||0.003|TWO_SIDED|95.0|31.6|137.1||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 24 - Adolescents||137.1|31.6|0.003
72378902|NCT02751931|144265893|OTHER||Mean Difference (Net)|60.09||||0.003|TWO_SIDED|95.0|21.2|99.0||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 36 - Children||99.0|21.2|0.003
72378903|NCT02751931|144265893|OTHER||Mean Difference (Net)|54.78||||0.017|TWO_SIDED|95.0|10.6|98.9||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 36 - Adolescents||98.9|10.6|0.017
72378904|NCT02751931|144265893|OTHER||Mean Difference (Net)|53.51||||0.001|TWO_SIDED|95.0|22.6|84.4||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 52 - Children||84.4|22.6|0.001
72378905|NCT02751931|144265893|OTHER||Mean Difference (Net)|54.3||||0.021|TWO_SIDED|95.0|9.0|99.6||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 52 - Adolescents||99.6|9.0|0.021
72378906|NCT02751931|144265894|OTHER||Mean Difference (Net)|18.13||||0.113|TWO_SIDED|95.0|-4.5|40.7||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 2 - Children||40.7|-4.5|0.113
72378907|NCT02751931|144265894|OTHER||Mean Difference (Net)|35.58||||0.056|TWO_SIDED|95.0|-1.1|72.2||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 2 - Adolescents||72.2|-1.1|0.056
72378908|NCT02751931|144265894|OTHER||Mean Difference (Net)|37.71||||0.005|TWO_SIDED|95.0|11.7|63.7|||t-test, 2 sided|From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.||Change From Baseline at Week 4 - Children||63.7|11.7|0.005
72378909|NCT02751931|144265894|OTHER||Mean Difference (Net)|70.35||||0.006|TWO_SIDED|95.0|22.2|118.5||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 4 - Adolescents||118.5|22.2|0.006
72378910|NCT02751931|144265894|OTHER||Mean Difference (Net)|43.91|||<|0.001|TWO_SIDED|95.0|21.0|66.8||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 8 - Children||66.8|21.0|<0.001
72378911|NCT02751931|144265894|OTHER||Mean Difference (Net)|38.11||||0.063|TWO_SIDED|95.0|-2.2|78.4||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 8 - Adolescents||78.4|-2.2|0.063
72378912|NCT02751931|144265894|OTHER||Mean Difference (Net)|29.05||||0.008|TWO_SIDED|95.0|8.2|49.9||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 12 - Children||49.9|8.2|0.008
72378913|NCT02751931|144265894|OTHER||Mean Difference (Net)|43.04||||0.009|TWO_SIDED|95.0|11.9|74.2||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 12 - Adolescents||74.2|11.9|0.009
72378914|NCT02751931|144265894|OTHER||Mean Difference (Net)|44.2||||0.006|TWO_SIDED|95.0|13.2|75.2||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 24 - Children||75.2|13.2|0.006
72378915|NCT02751931|144265894|OTHER||Mean Difference (Net)|81.37||||0.003|TWO_SIDED|95.0|30.4|132.3||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 24 - Adolescents||132.3|30.4|0.003
72378916|NCT02751931|144265894|OTHER||Mean Difference (Net)|58.49||||0.004|TWO_SIDED|95.0|19.8|97.2||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 36 - Children||97.2|19.8|0.004
72378917|NCT02751931|144265894|OTHER||Mean Difference (Net)|50.9||||0.039|TWO_SIDED|95.0|2.7|99.1||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 36 - Adolescents||99.1|2.7|0.039
72378918|NCT02751931|144265894|OTHER||Mean Difference (Net)|53.76||||0.002|TWO_SIDED|95.0|21.7|85.8||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 52 - Children||85.8|21.7|0.002
72618512|NCT01026038|144768103|SUPERIORITY_OR_OTHER||GMC ratio|0.8|||||TWO_SIDED|95.0|0.61|1.05||||||Serotype 23F: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||1.05|0.61|
72618513|NCT01026038|144768103|SUPERIORITY_OR_OTHER||GMC ratio|0.95|||||TWO_SIDED|95.0|0.73|1.25||||||Serotype 23F: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.25|0.73|
72378919|NCT02751931|144265894|OTHER||Mean Difference (Net)|49.13||||0.057|TWO_SIDED|95.0|-1.6|99.8||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 52 - Adolescents||99.8|-1.6|0.057
72378920|NCT02751931|144265895|OTHER||Mean Difference (Net)|7.98||||0.617|TWO_SIDED|95.0|-24.0|40.0||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 2 - Children||40.0|-24.0|0.617
72378921|NCT02751931|144265895|OTHER||Mean Difference (Net)|39.52||||0.035|TWO_SIDED|95.0|3.0|76.0||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 2 - Adolescents||76.0|3.0|0.035
72378922|NCT02751931|144265895|OTHER||Mean Difference (Net)|19.81||||0.167|TWO_SIDED|95.0|-8.7|48.3||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 4 - Children||48.3|-8.7|0.167
72378923|NCT02751931|144265895|OTHER||Mean Difference (Net)|75.25||||0.005|TWO_SIDED|95.0|25.8|124.7||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 4 - Adolescents||124.7|25.8|0.005
72378924|NCT02751931|144265895|OTHER||Mean Difference (Net)|34.01||||0.02|TWO_SIDED|95.0|5.7|62.3||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 8 - Children||62.3|5.7|0.020
72378925|NCT02751931|144265895|OTHER||Mean Difference (Net)|44.43||||0.033|TWO_SIDED|95.0|3.9|84.9||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 8 - Adolescents||84.9|3.9|0.033
72378926|NCT02751931|144265895|OTHER||Mean Difference (Net)|8.68||||0.503|TWO_SIDED|95.0|-17.3|34.7||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0|t-test, 2 sided|||Change From Baseline at Week 12 - Children||34.7|-17.3|0.503
72378927|NCT02751931|144265895|OTHER||Mean Difference (Net)|38.23||||0.016|TWO_SIDED|95.0|7.8|68.6||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 12 - Adolescents||68.6|7.8|0.016
72378928|NCT02751931|144265895|OTHER||Mean Difference (Net)|40.76||||0.043|TWO_SIDED|95.0|1.4|80.2||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 24 - Children||80.2|1.4|0.043
72378929|NCT02751931|144265895|OTHER||Mean Difference (Net)|86.66|||<|0.001|TWO_SIDED|95.0|41.5|131.8||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 24 - Adolescents||131.8|41.5|<0.001
72378930|NCT02751931|144265895|OTHER||Mean Difference (Net)|31.08||||0.203|TWO_SIDED|95.0|-17.5|79.6||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 36 - Children||79.6|-17.5|0.203
72378931|NCT02751931|144265895|OTHER||Mean Difference (Net)|68.47||||0.019|TWO_SIDED|95.0|12.7|124.2||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 36 - Adolescents||124.2|12.7|0.019
72378932|NCT02751931|144265895|OTHER||Mean Difference (Net)|31.83||||0.042|TWO_SIDED|95.0|1.3|62.4||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 52 - Children||62.4|1.3|0.042
72378933|NCT02751931|144265895|OTHER||Mean Difference (Net)|38.14||||0.121|TWO_SIDED|95.0|-11.0|87.3||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 52 - Adolescents||87.3|-11.0|0.121
72378934|NCT02751931|144265896|OTHER||Mean Difference (Net)|0.35||||0.818|TWO_SIDED|95.0|-2.7|3.4||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 2 - Children||3.4|-2.7|0.818
72378935|NCT02751931|144265896|OTHER||Mean Difference (Net)|-0.53||||0.114|TWO_SIDED|95.0|-1.2|0.1||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 2 - Adolescents||0.1|-1.2|0.114
72378936|NCT02751931|144265896|OTHER||Mean Difference (Net)|-1.14||||0.052|TWO_SIDED|95.0|-2.3|0.0||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 4 - Children||0.0|-2.3|0.052
72378937|NCT02751931|144265896|OTHER||Mean Difference (Net)|-0.87||||0.066|TWO_SIDED|95.0|-1.8|0.1||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 4 - Adolescents||0.1|-1.8|0.066
72378938|NCT02751931|144265896|OTHER||Mean Difference (Net)|1.16||||0.674|TWO_SIDED|95.0|-4.4|6.7||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 8 - Children||6.7|-4.4|0.674
72556319|NCT00862563|144643980|SUPERIORITY_OR_OTHER||Difference between least squares means|-29.7|STANDARD_ERROR_OF_MEAN|9.2||0.0015|TWO_SIDED|||||p\< 0.05 is considered to be significant|ANOVA|||Comparison of Week 11 means for mean percent heavy drinking days obtained for the placebo and topiramate groups Means used for the analysis are least squares means from a two-way repeated measures mixed models analysis, with Week (time) as the the within subject factor and treatment as the between group factor. Baseline values were used as covariates.||||0.0015
72378939|NCT02751931|144265896|OTHER||Mean Difference (Net)|-0.65||||0.278|TWO_SIDED|95.0|-1.9|0.6||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 8 - Adolescents||0.6|-1.9|0.278
72378940|NCT02751931|144265896|OTHER||Mean Difference (Net)|0.37||||0.871|TWO_SIDED|95.0|-4.2|5.0||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 12 - Children||5.0|-4.2|0.871
72378941|NCT02751931|144265896|OTHER||Mean Difference (Net)|-0.65||||0.153|TWO_SIDED|95.0|-1.6|0.3||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 12 - Adolescents||0.3|-1.6|0.153
72378942|NCT02751931|144265896|OTHER||Mean Difference (Net)|0.18||||0.922|TWO_SIDED|95.0|-3.5|3.9||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 24 - Children||3.9|-3.5|0.922
72378943|NCT02751931|144265896|OTHER||Mean Difference (Net)|-0.75||||0.047|TWO_SIDED|95.0|-1.5|0.0||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 24 - Adolescents||0.0|-1.5|0.047
72378944|NCT02751931|144265896|OTHER||Mean Difference (Net)|-1.98||||0.018|TWO_SIDED|95.0|-3.6|-0.4||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 36 - Children||-0.4|-3.6|0.018
72378945|NCT02751931|144265896|OTHER||Mean Difference (Net)|-0.81||||0.07|TWO_SIDED|95.0|-1.7|0.1||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 36 - Adolescents||0.1|-1.7|0.070
72378946|NCT02751931|144265896|OTHER||Mean Difference (Net)|-0.94||||0.083|TWO_SIDED|95.0|-2.0|0.1||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 52 - Children||0.1|-2.0|0.083
72378947|NCT02751931|144265896|OTHER||Mean Difference (Net)|-1.12||||0.064|TWO_SIDED|95.0|-2.3|0.1||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 52 - Adolescents||0.1|-2.3|0.064
72378948|NCT02751931|144265897|OTHER|||||||0.692||||||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 2 - Children||||0.692
72378949|NCT02751931|144265897|OTHER|||||||0.018||||||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 2 - Adolescents||||0.018
72378950|NCT02751931|144265897|OTHER|||||||0.061||||||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 4 - Children||||0.061
72378951|NCT02751931|144265897|OTHER|||||||0.008||||||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 4 - Adolescents||||0.008
72378952|NCT02751931|144265897|OTHER|||||||0.612||||||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 8 - Children||||0.612
72378953|NCT02751931|144265897|OTHER|||||||0.018||||||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 8 - Adolescents||||0.018
72378954|NCT02751931|144265897|OTHER|||||||0.858||||||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 12 - Children||||0.858
72378955|NCT02751931|144265897|OTHER|||||||0.004||||||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 12 - Adolescents||||0.004
72378956|NCT02751931|144265897|OTHER|||||||0.003||||||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 24 - Children||||0.003
72378957|NCT02751931|144265897|OTHER||||||<|0.001||||||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 24 - Adolescents||||< 0.001
72378958|NCT02751931|144265897|OTHER|||||||0.045||||||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 36 - Children||||0.045
72378959|NCT02751931|144265897|OTHER|||||||0.002||||||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 36 - Adolescents||||0.002
72378960|NCT02751931|144265897|OTHER|||||||0.006||||||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 52 - Children||||0.006
72378961|NCT02751931|144265897|OTHER|||||||0.007||||||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 52 - Adolescents||||0.007
72378962|NCT02751931|144265898|OTHER||Mean Difference (Net)|0.34||||0.018|TWO_SIDED|95.0|0.1|0.6||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 2 - Children||0.6|0.1|0.018
72378963|NCT02751931|144265898|OTHER||Mean Difference (Net)|0.82||||0.045|TWO_SIDED|95.0|0.0|1.6||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 2 - Adolescents||1.6|0.0|0.045
72378964|NCT02751931|144265898|OTHER||Mean Difference (Net)|0.68||||0.013|TWO_SIDED|95.0|0.1|1.2||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 4 - Children||1.2|0.1|0.013
72378965|NCT02751931|144265898|OTHER||Mean Difference (Net)|1.36||||0.002|TWO_SIDED|95.0|0.6|2.2||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 4 - Adolescents||2.2|0.6|0.002
72378966|NCT02751931|144265898|OTHER||Mean Difference (Net)|1.14||||0.001|TWO_SIDED|95.0|0.5|1.8||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 8 - Children||1.8|0.5|0.001
72378967|NCT02751931|144265898|OTHER||Mean Difference (Net)|2.26|||<|0.001|TWO_SIDED|95.0|1.2|3.3||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 8 - Adolescents||3.3|1.2|<0.001
72378968|NCT02751931|144265898|OTHER||Mean Difference (Net)|1.31||||0.001|TWO_SIDED|95.0|0.5|2.1||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 12 - Children||2.1|0.5|0.001
72378969|NCT02751931|144265898|OTHER||Mean Difference (Net)|1.93|||<|0.001|TWO_SIDED|95.0|0.9|3.0||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 12 - Adolescents||3.0|0.9|<0.001
72378970|NCT02751931|144265898|OTHER||Mean Difference (Net)|1.34|||<|0.001|TWO_SIDED|95.0|0.7|2.0||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 24 - Children||2.0|0.7|<0.001
72378971|NCT02751931|144265898|OTHER||Mean Difference (Net)|2.17|||<|0.001|TWO_SIDED|95.0|1.2|3.2||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 24 - Adolescents||3.2|1.2|<0.001
72618514|NCT01026038|144768103|SUPERIORITY_OR_OTHER||GMC ratio|1.19|||||TWO_SIDED|95.0|0.87|1.64||||||Serotype 23F: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.64|0.87|
72378972|NCT02751931|144265898|OTHER||Mean Difference (Net)|1.33||||0.002|TWO_SIDED|95.0|0.5|2.1||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 36 - Children||2.1|0.5|0.002
72378973|NCT02751931|144265898|OTHER||Mean Difference (Net)|1.88|||<|0.001|TWO_SIDED|95.0|1.0|2.8||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 36 - Adolescents||2.8|1.0|<0.001
72378974|NCT02751931|144265898|OTHER||Mean Difference (Net)|1.38||||0.002|TWO_SIDED|95.0|0.5|2.2||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 52 - Children||2.2|0.5|0.002
72378975|NCT02751931|144265898|OTHER||Mean Difference (Net)|2.14|||<|0.001|TWO_SIDED|95.0|1.1|3.2||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 52 - Adolescents||3.2|1.1|<0.001
72378976|NCT02751931|144265899|OTHER||Mean Difference (Net)|2.04||||0.352|TWO_SIDED|95.0|-2.4|6.49||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 24 - Children||6.49|-2.40|0.352
72378977|NCT02751931|144265899|OTHER||Mean Difference (Net)|-4.9||||0.127|TWO_SIDED|95.0|-11.34|1.53||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 24 - Adolescents||1.53|-11.34|0.127
72378978|NCT02751931|144265899|OTHER||Mean Difference (Net)|1.3||||0.613|TWO_SIDED|95.0|-3.96|6.57||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 52 - Children||6.57|-3.96|0.613
72378979|NCT02751931|144265899|OTHER||Mean Difference (Net)|-6.79||||0.056|TWO_SIDED|95.0|-13.78|0.2||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 52 - Adolescents||0.20|-13.78|0.056
72378980|NCT02751931|144265900|OTHER||Mean Difference (Net)|0.36||||0.153|TWO_SIDED|95.0|-0.14|0.86||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 24 - Children||0.86|-0.14|0.153
72378981|NCT02751931|144265900|OTHER||Mean Difference (Net)|0.64||||0.007|TWO_SIDED|95.0|0.19|1.08||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 24 - Adolescents||1.08|0.19|0.007
72378982|NCT02751931|144265900|OTHER||Mean Difference (Net)|0.42||||0.106|TWO_SIDED|95.0|-0.1|0.93||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 52 - Children||0.93|-0.10|0.106
72378983|NCT02751931|144265900|OTHER||Mean Difference (Net)|0.95||||0.003|TWO_SIDED|95.0|0.38|1.51||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 52 - Adolescents||1.51|0.38|0.003
72378984|NCT01037088|144265916|SUPERIORITY||||||>|0.05||||||not significant|Mixed Models Analysis|||Hour 1 after Administration of Cannabis||||>.05
72378985|NCT01037088|144265916|SUPERIORITY||||||=|0.0002|||||||Mixed Models Analysis|||Hour 2 after Administration of Cannabis||||=.0002
72378986|NCT01037088|144265916|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||Hour 3 after Administration of Cannabis (after the second inhalation of cannabis)||||<.0001
72378987|NCT01037088|144265916|SUPERIORITY||||||=|0.0004|||||||Mixed Models Analysis|||Hour 4 after Administration of Cannabis||||=.0004
72378988|NCT01037088|144265916|SUPERIORITY||||||=|0.0018|||||||Mixed Models Analysis|||Hour 5 after Administration of Cannabis||||=.0018
72378989|NCT04030026|144265950|SUPERIORITY||Geometric Mean Ratio|0.32|||<|0.0001|TWO_SIDED|95.0|0.208|0.431||Mixed-effects model: unstructured, heterogeneous toeplitz and autoregressive covariance matrices. Dependent variable: change from baseline in log-transformed scale of Daytime Cough Frequency. Fixed effects: sequence (arm), period and treatment.|Mixed-effects model|||||0.431|0.208|< 0.0001
72378990|NCT04030026|144265952|SUPERIORITY||Geometric Mean Ratio|0.32|||<|0.0001|TWO_SIDED|95.0|0.208|0.431||Mixed-effects model: unstructured, heterogeneous toeplitz and autoregressive covariance matrices. Dependent variable: change from baseline in log-transformed scale of Daytime Cough Frequency. Fixed effects: sequence (arm), period and treatment.|Mixed-effects model|||||0.431|0.208|<0.0001
72378991|NCT04030026|144265953|SUPERIORITY||Geometric Mean Ratio|0.47||||0.0087|TWO_SIDED|95.0|0.23|0.717||Mixed-effects model: unstructured, heterogeneous toeplitz and autoregressive covariance matrices. Dependent variable: change from baseline in log-transformed scale of Daytime Cough Frequency. Fixed effects: sequence (arm), period and treatment.|Mixed-effects model|||||0.717|0.230|0.0087
72378992|NCT04030026|144265954|SUPERIORITY|||||||0.0014||||||Student's T-test was used to evaluate if the difference in mean change from baseline is different between planned treatments (NAL ER vs placebo).|Student's T-test|||Change from baseline at Day 9||||0.0014
72378993|NCT04030026|144265954|SUPERIORITY|||||||0.0001||||||Student's T-test was used to evaluate if the difference in mean change from baseline is different between planned treatments (NAL ER vs placebo).|Student's T-test|||Change from baseline at Day 16||||0.0001
72618515|NCT01026038|144768103|SUPERIORITY_OR_OTHER||GMC ratio|3.62|||||TWO_SIDED|95.0|2.76|4.74||||||Serotype 1: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||4.74|2.76|
72378994|NCT04030026|144265954|SUPERIORITY|||||||0.001||||||Student's T-test was used to evaluate if the difference in mean change from baseline is different between planned treatments (NAL ER vs placebo).|Student's T-test|||Change from baseline at Day 22||||0.001
72378995|NCT04030026|144265955|SUPERIORITY|||||||0.0198||||||Student's T-test was used to evaluate if the difference in mean change from baseline is different between planned treatments (NAL ER vs placebo).|Student's T-test|||Change from baseline at Day 9||||0.0198
72378996|NCT04030026|144265955|SUPERIORITY|||||||0.0374||||||Student's T-test was used to evaluate if the difference in mean change from baseline is different between planned treatments (NAL ER vs placebo).|Student's T-test|||Change from baseline at Day 16||||0.0374
72378997|NCT04030026|144265955|SUPERIORITY|||||||0.2982||||||Student's T-test was used to evaluate if the difference in mean change from baseline is different between planned treatments (NAL ER vs placebo).|Student's T-test|||Change from baseline at Day 22||||0.2982
72378998|NCT04030026|144265956|SUPERIORITY|||||||0.0054||||||Student's T-test was used to evaluate if the difference in mean change from baseline is different between planned treatments (NAL ER vs placebo)|Student's T-test|||Change from baseline at Day 8||||0.0054
72378999|NCT04030026|144265956|SUPERIORITY||||||<|0.0001||||||Student's T-test was used to evaluate if the difference in mean change from baseline is different between planned treatments (NAL ER vs placebo).|Student's T-test|||Change from baseline at Day 15||||<0.0001
72379000|NCT04030026|144265956|SUPERIORITY|||||||0.0001||||||Student's T-test was used to evaluate if the difference in mean change from baseline is different between planned treatments (NAL ER vs placebo).|Student's T-test|||Change from baseline at Day 21||||0.0001
72379001|NCT04030026|144265957|SUPERIORITY|||||||0.0107||||||Student's T-test was used to evaluate if the difference in mean change from baseline is different between planned treatments (NAL ER vs placebo).|Student's T-test|||Change from baseline at Day 9||||0.0107
72379002|NCT04030026|144265957|SUPERIORITY|||||||0.0051||||||Student's T-test was used to evaluate if the difference in mean change from baseline is different between planned treatments (NAL ER vs placebo).|Student's T-test|||Change for baseline at Day 16||||0.0051
72379003|NCT04030026|144265957|SUPERIORITY|||||||0.1513||||||Student's T-test was used to evaluate if the difference in mean change from baseline is different between planned treatments (NAL ER vs placebo).|Student's T-test|||Change from baseline at Day 22||||0.1513
72379004|NCT04030026|144265958|SUPERIORITY|||||||0.3601||||||Student's T-test was used to evaluate if the difference in mean change from baseline is different between planned treatments (NAL ER vs placebo).|Student's T-test|||||||0.3601
72379005|NCT02207946|144265960|SUPERIORITY||LS mean difference|-0.43|STANDARD_ERROR_OF_MEAN|0.28||0.144|TWO_SIDED|95.0|-1.02|0.16|||ANCOVA|||Least square (LS) means are from analysis of covariance (ANCOVA) with treatment and site included as fixed factors and baseline included as covariate.||0.16|-1.02|0.144
72379006|NCT02104739|144266035|SUPERIORITY|||||||0.27|||||||Non-parametric Wilcoxon paired rank sum|||Exenatide at baseline and 2 hours after ingestion of meal is compared.||||0.27
72379007|NCT02104739|144266035|SUPERIORITY|||||||0.59|||||||Non-parametric Wilcoxon paired rank sum|||Saxagliptin at baseline and 2 hours after ingestion of meal is compared.||||0.59
72379008|NCT02104739|144266035|SUPERIORITY|||||||0.51|||||||Non-parametric Wilcoxon paired rank sum|||Placebo at baseline and 2 hours after ingestion of meal is compared.||||0.51
72379009|NCT02104739|144266035|SUPERIORITY|||||||0.31|||||||Non-parametric Wilcoxon paired rank sum|||Exenatide extended-release (ER) at baseline and 2 hours after ingestion of meal is compared.||||0.31
72379010|NCT02104739|144266037|SUPERIORITY|||||||0.02|||||||ANOVA|||||||0.02
72379011|NCT02104739|144266039|SUPERIORITY||||||<|0.05|||||||ANOVA|||The reported p-value compares exenatide and saxagliptin over all time points (2 hours, 4 hours, 6 hours).||||<0.05
72379012|NCT02104739|144266039|SUPERIORITY||||||<|0.05|||||||ANOVA|||The reported p-value compares exenatide and placebo over all time points (2 hours, 4 hours, 6 hours).||||<0.05
72379013|NCT02104739|144266041|SUPERIORITY|||||||0.018|||||||ANOVA|||||||0.018
72379014|NCT02104739|144266043|SUPERIORITY||||||<|0.05|||||||ANOVA|||The reported p-value compares exenatide and saxagliptin over all time points (2 hours, 4 hours, 6 hours).||||<0.05
72379015|NCT02104739|144266043|SUPERIORITY||||||<|0.05|||||||ANOVA|||The reported p-value compares exenatide and placebo over all time points (2 hours, 4 hours, 6 hours).||||<0.05
72379016|NCT02104739|144266045|SUPERIORITY|||||||0.5|||||||ANOVA|||||||0.5
72379017|NCT02104739|144266046|SUPERIORITY||||||>|0.05|||||||ANOVA|||The reported p-value compares exenatide and saxagliptin over all time points (3 hours, 6 hours).||||>0.05
72379018|NCT02104739|144266046|SUPERIORITY||||||>|0.05|||||||ANOVA|||The reported p-value compares exenatide and placebo over all time points (3 hours, 6 hours).||||>0.05
72379019|NCT05772702|144266047|OTHER|This was a single-arm, open-label trial. Reported statistics reflect changes from baseline levels.|||||<|0.0005|||||||t-test, 2 sided|||HDRS-17 change score were submitted to a t-test to estimate the group difference from 0 (i.e., no change in depression symptoms from D1 to FU2). Null hypothesis: D1 == FU2||||<0.0005
72379020|NCT05772702|144266048|OTHER|This was a single-arm, open-label trial. Reported statistics reflect changes from baseline levels.|||||<|0.0005|||||||t-test, 2 sided|||HDRS-17 change score were submitted to a t-test to estimate the group difference from 0 (i.e., no change in depression symptoms from D1 to D5). Note: D5 HDRS-17 were determined prior to receiving the final treatment on D5. Null hypothesis: D1 == D5||||<0.0005
72379021|NCT05772702|144266050|OTHER|This was a single-arm, open-label trial. Reported statistics reflect changes from baseline levels.|||||<|0.0005|||||||ANOVA|Mauchly's test of sphericity determined the sphericity assumption was violated, so Greenhouse-Geisser corrections were applied.||QIDS change score were submitted to a repeated measures ANOVA to measure change from baseline over time. Note: D5 QIDS surveys were completed prior to receiving the final treatment on D5. Null hypothesis: D1 = D5 = FU1 = FU2||||<0.0005
72379022|NCT05772702|144266051|OTHER|This was a single-arm, open-label trial. Reported statistics reflect changes from baseline levels.|||||<|0.0005|||||||ANOVA|||ASRM scores were submitted to a repeated measures ANOVA to measure change from baseline over time. Note: D5 ASRM surveys were completed prior to receiving the final treatment on D5. Null hypothesis: D1 = D5 = FU1 = FU2||||<0.0005
72379023|NCT05772702|144266052|OTHER|This was a single-arm, open-label trial. Reported statistics reflect changes from baseline levels.|||||<|0.0005|||||||ANOVA|Mauchly's test of sphericity determined the sphericity assumption was violated, so Greenhouse-Geisser corrections were applied.||SHAPS scores were submitted to a repeated measures ANOVA to measure change from baseline over time. Note: D5 SHAPS surveys were completed prior to receiving the final treatment on D5. Null hypothesis: D1 = D5 = FU1 = FU2||||<0.0005
72379024|NCT05772702|144266053|OTHER|This was a single-arm, open-label trial. Reported statistics reflect changes from baseline levels.|||||<|0.0005|||||||ANOVA|Mauchly's test of sphericity determined the sphericity assumption was violated, so Greenhouse-Geisser corrections were applied.||DASS-42 OVERALL scores were submitted to a repeated measures ANOVA to measure change from baseline over time. Note: D5 DASS-42 surveys were completed prior to receiving the final treatment on D5. Null hypothesis: D1 = D5 = FU1 = FU2||||<0.0005
72379025|NCT05772702|144266053|OTHER|This was a single-arm, open-label trial. Reported statistics reflect changes from baseline levels.|||||<|0.0005|||||||ANOVA|This subscale did not require sphericity corrections.||DASS-42 DEPRESSION SUBSCORES were submitted to a repeated measures ANOVA to measure change from baseline over time. Note: D5 DASS-42 surveys were completed prior to receiving the final treatment on D5. Null hypothesis: D1 = D5 = FU1 = FU2||||<0.0005
72379026|NCT05772702|144266053|OTHER|This was a single-arm, open-label trial. Reported statistics reflect changes from baseline levels.|||||<|0.0005|||||||ANOVA|Mauchly's test of sphericity determined the sphericity assumption was violated, so Greenhouse-Geisser corrections were applied.||DASS-42 ANXIETY SUBSCORES were submitted to a repeated measures ANOVA to measure change from baseline over time. Note: D5 DASS-42 surveys were completed prior to receiving the final treatment on D5. Null hypothesis: D1 = D5 = FU1 = FU2||||<0.0005
72433616|NCT00991276|144380373|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|1.84|STANDARD_ERROR_OF_MEAN|0.53||0.0007|TWO_SIDED|95.0|0.79|2.89||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||2.89|0.79|0.0007
72379027|NCT05772702|144266053|OTHER|This was a single-arm, open-label trial. Reported statistics reflect changes from baseline levels.|||||<|0.0005|||||||ANOVA|Mauchly's test of sphericity determined the sphericity assumption was violated, so Greenhouse-Geisser corrections were applied.||DASS-42 STRESS SUBSCORES were submitted to a repeated measures ANOVA to measure change from baseline over time. Note: D5 DASS-42 surveys were completed prior to receiving the final treatment on D5. Null hypothesis: D1 = D5 = FU1 = FU2||||<0.0005
72379028|NCT05772702|144266054|OTHER|This was a single-arm, open-label trial. Reported statistics reflect changes from baseline levels.||||||0.021|||||||ANOVA|Mauchly's test of sphericity determined the sphericity assumption was violated, so Greenhouse-Geisser corrections were applied.||STAI scores were submitted to a repeated measures ANOVA to measure change from baseline over time. Note: D5 STAI surveys were completed prior to receiving the final treatment on D5. Null hypothesis: D1 = D5 = FU1 = FU2||||0.021
72379029|NCT05772702|144266055|OTHER|This was a single-arm, open-label trial. Reported statistics reflect changes from baseline levels.|||||<|0.0005|||||||ANOVA|||QIDS scores were submitted to a repeated measures ANOVA to measure change from baseline over time. Note: D5 QIDS surveys were completed prior to receiving the final treatment on D5. Null hypothesis: D1 = D5 = FU1 = FU2||||<0.0005
72379030|NCT05772702|144266056|OTHER|This was a single-arm, open-label trial. Reported statistics reflect changes from baseline levels.|||||<|0.0005|||||||ANOVA|||CGI severity scores were submitted to a repeated measures ANOVA to measure change from baseline over time. Note: D5 CGI assessments were completed prior to receiving the final treatment on D5. Null hypothesis: D1 = D5 = FU2||||<0.0005
72379031|NCT05772702|144266056|OTHER|This was a single-arm, open-label trial. Reported statistics reflect changes from baseline levels.||||||0.006|||||||t-test, 2 sided|||CGI improvement scores were submitted to a paired t-test to measure difference between the improvement assessment on D5 and the assessment at FU2. Note: D5 CGI assessments were completed prior to receiving the final treatment on D5. Null hypothesis: D5 = FU2||||0.006
72379032|NCT01362595|144266079|OTHER||||||||||||||||||Due to the small sample size, the statistical approach is primarily descriptive in nature.|||
72379033|NCT01083173|144266134|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Paired t-test|||CD4 cell counts at 24 weeks as compared to baseline||||< 0.0001
72379034|NCT01083173|144266134|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Paired t-test|||CD4 cell counts at 48 weeks as compared to baseline||||< 0.0001
72379035|NCT01850602|144266148|NON_INFERIORITY|"Non-Inferiority margin: 1.0 mg/dL~Non-Inferiority was considerd to be confirmed if the upper limit of two-sided confidence interval became 1.0 mg/dL or less."|Mean Difference (Final Values)|-0.34||||0.02|TWO_SIDED|95.0|-0.63|-0.05|||ANCOVA|||||-0.05|-0.63|0.020
72379036|NCT01857310|144266152|SUPERIORITY||Risk Difference (RD)|-0.9|||||TWO_SIDED|95.0|-4.7|2.8|||||Adjusted for infertility treatment stratum and study site|"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. Live birth will be compared using two sided tests conducted at the 0.05 level."||2.8|-4.7|
72379037|NCT01857310|144266152|SUPERIORITY||Risk Ratio (RR)|0.98|||||TWO_SIDED|95.0|0.88|1.09|||||Adjusted for infertility treatment stratum and study site|"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. Live birth will be compared using two sided tests conducted at the 0.05 level."||1.09|0.88|
72379038|NCT01857310|144266153|SUPERIORITY||Mean Difference (Final Values)|0.0|||||TWO_SIDED|95.0|-0.2|0.2|||||Adjusted for infertility treatment stratum and study site.|"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. Semen volume will be compared using two sided tests conducted at the 0.05 level."||0.2|-0.2|
72618516|NCT01026038|144768103|SUPERIORITY_OR_OTHER||GMC ratio|0.52|||||TWO_SIDED|95.0|0.4|0.68||||||Serotype 1: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||0.68|0.40|
72379039|NCT01857310|144266153|SUPERIORITY||Mean Difference (Final Values)|0.0|||||TWO_SIDED|95.0|-0.1|0.2|||||Weighted for loss to follow-up and adjusted for infertility treatment stratum and study site.|"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. Semen volume will be compared using two sided tests conducted at the 0.05 level."||0.2|-0.1|
72379040|NCT01857310|144266154|SUPERIORITY||Mean Difference (Final Values)|-4.3|||||TWO_SIDED|95.1|-12.5|3.9|||||Adjusted for infertility treatment stratum and study site.|"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. The confidence interval for sperm concentration represents 95.1% coverage to properly account for the alpha spent in the interim analysis."||3.9|-12.5|
72379041|NCT01857310|144266154|SUPERIORITY||Mean Difference (Final Values)|-5.2|||||TWO_SIDED|95.1|-13.6|3.1|||||Weighted for loss to follow-up and adjusted for fertility treatment stratum and study site.|"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. The confidence interval for sperm concentration represents 95.1% coverage to properly account for the alpha spent in the interim analysis."||3.1|-13.6|
72379042|NCT01857310|144266155|SUPERIORITY||Mean Difference (Final Values)|-0.5|||||TWO_SIDED|95.1|-2.5|1.5|||||Adjusted for infertility treatment stratum and study site.|"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. The confidence interval for sperm motility represents 95.1% coverage to properly account for the alpha spent in the interim analysis."||1.5|-2.5|
72379043|NCT01857310|144266155|SUPERIORITY||Mean Difference (Final Values)|-0.6|||||TWO_SIDED|95.1|-2.7|1.4|||||Weighted for loss to follow-up and adjusted for infertility treatment stratum and study site.|"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. The confidence interval for sperm motility represents 95.1% coverage to properly account for the alpha spent in the interim analysis."||1.4|-2.7|
72379044|NCT01857310|144266156|SUPERIORITY||Mean Difference (Final Values)|-0.4|||||TWO_SIDED|95.1|-0.8|0.1|||||Adjusted for infertility treatment stratum and study site.|"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. The confidence interval for sperm morphology represents 95.1% coverage to properly account for the alpha spent in the interim analysis."||0.1|-0.8|
72618517|NCT01026038|144768103|SUPERIORITY_OR_OTHER||GMC ratio|0.14|||||TWO_SIDED|95.0|0.1|0.2||||||Serotype 1: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||0.20|0.10|
72618518|NCT01026038|144768103|SUPERIORITY_OR_OTHER||GMC ratio|1.13|||||TWO_SIDED|95.0|0.8|1.59||||||Serotype 3: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||1.59|0.80|
72379045|NCT01857310|144266156|SUPERIORITY||Mean Difference (Final Values)|-0.4|||||TWO_SIDED|95.1|-0.9|0.0|||||Weighted for loss to follow-up and adjusted for infertility treatment stratum and study site.|"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. The confidence interval for sperm morphology represents 95.1% coverage to properly account for the alpha spent in the interim analysis."||0|-0.9|
72379046|NCT01857310|144266157|SUPERIORITY||Mean Difference (Final Values)|2.4|||||TWO_SIDED|95.0|0.5|4.4|||||Adjusted for infertility treatment stratum and study site.|"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. DNA fragmentation will be compared using two sided tests conducted at the 0.05 level."||4.4|0.5|
72379047|NCT01857310|144266157|SUPERIORITY||Mean Difference (Final Values)|2.3|||||TWO_SIDED|95.0|0.3|4.3|||||Weighted for loss to follow-up and adjusted for infertility treatment stratum and study site.|"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. DNA fragmentation will be compared using two sided tests conducted at the 0.05 level."||4.3|0.3|
72379048|NCT01857310|144266158|SUPERIORITY||Mean Difference (Final Values)|1.4|||||TWO_SIDED|95.0|-19.7|22.5|||||Adjusted for infertility treatment stratum and study site.|"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. Total motile sperm count will be compared using two sided tests conducted at the 0.05 level."||22.5|-19.7|
72379049|NCT01857310|144266158|SUPERIORITY||Mean Difference (Final Values)|0.3|||||TWO_SIDED|95.0|-20.9|21.4|||||Weighted for loss to follow-up and adjusted for infertility treatment stratum and study site.|"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. Total motile sperm count will be compared using two sided tests conducted at the 0.05 level."||21.4|-20.9|
72379050|NCT01857310|144266159|SUPERIORITY||Risk Difference (RD)|-0.9|||||TWO_SIDED|95.0|-4.7|3.0|||||Adjusted for infertility treatment stratum and study site.|"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. hCG detected pregnancy will be compared using two sided tests conducted at the 0.05 level."||3.0|-4.7|
72379051|NCT01857310|144266159|SUPERIORITY||Risk Ratio (RR)|1.0|||||TWO_SIDED|95.0|0.91|1.09|||||Adjusted for infertility treatment stratum and study site.|"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. hCG detected pregnancy will be compared using two sided tests conducted at the 0.05 level."||1.09|0.91|
72379052|NCT01857310|144266160|SUPERIORITY||Risk Difference (RD)|-1.0|||||TWO_SIDED|95.0|-4.9|2.8|||||Adjusted for infertility treatment stratum and study site.|"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. Clinical intrauterine pregnancy will be compared using two sided tests conducted at the 0.05 level."||2.8|-4.9|
72379053|NCT01857310|144266160|SUPERIORITY||Risk Ratio (RR)|0.98|||||TWO_SIDED|95.0|0.89|1.08|||||Adjusted for infertility treatment stratum and study site.|"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. Clinical intrauterine pregnancy will be compared using two sided tests conducted at the 0.05 level."||1.08|0.89|
72379054|NCT01857310|144266161|SUPERIORITY||Risk Difference (RD)|0.1|||||TWO_SIDED|95.0|-0.5|0.6|||||Adjusted for infertility treatment stratum and study site.|"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. Ectopic pregnancy will be compared using two sided tests conducted at the 0.05 level."||0.6|-0.5|
72379055|NCT01857310|144266161|SUPERIORITY||Risk Ratio (RR)|1.21|||||TWO_SIDED|95.0|0.37|3.97|||||Adjusted for fertility treatment stratum and study site.|"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. Ectopic pregnancy will be compared using two sided tests conducted at the 0.05 level."||3.97|0.37|
72379056|NCT01857310|144266162|SUPERIORITY||Risk Difference (RD)|-1.1|||||TWO_SIDED|95.0|-3.7|1.5|||||Adjusted for infertility treatment stratum and study site.|"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. Early pregnancy loss will be compared using two sided tests conducted at the 0.05 level."||1.5|-3.7|
72379057|NCT01857310|144266162|SUPERIORITY||Risk Ratio (RR)|0.93|||||TWO_SIDED|95.0|0.75|1.15|||||Adjusted for infertility treatment stratum and study site.|"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. Early pregnancy loss will be compared using two sided tests conducted at the 0.05 level."||1.15|0.75|
72556320|NCT00862563|144643980|SUPERIORITY_OR_OTHER||Difference between least squares means|-37.7|STANDARD_ERROR_OF_MEAN|9.3|<|0.0001|TWO_SIDED|||||p\<0.05 is considered to be significant.|ANOVA|||Comparison of Week 12 means for mean percent heavy drinking days obtained for the placebo and topiramate groups Means used for the analysis are least squares means from a two-way repeated measures mixed models analysis, with Week (time) as the the within subject factor and treatment as the between group factor. Baseline values were used as covariates.||||<0.0001
72379058|NCT01857310|144266163|SUPERIORITY||Risk Difference (RD)|-0.3|||||TWO_SIDED|95.0|-1.9|1.3|||||Adjusted for infertility treatment stratum and study site.|"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. Preeclampsia/gestational hypertension will be compared using two sided tests conducted at the 0.05 level."||1.3|-1.9|
72379059|NCT01857310|144266163|SUPERIORITY||Risk Ratio (RR)|0.92|||||TWO_SIDED|95.0|0.63|1.36|||||Adjusted for infertility treatment stratum and study site.|"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. Preeclampsia/gestational hypertension will be compared using two sided tests conducted at the 0.05 level."||1.36|0.63|
72379060|NCT01857310|144266164|SUPERIORITY||Risk Difference (RD)|-0.7|||||TWO_SIDED|95.0|-1.9|0.6|||||Adjusted for infertility treatment stratum and study site.|"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. Gestational diabetes will be compared using two sided tests conducted at the 0.05 level."||0.6|-1.9|
72379061|NCT01857310|144266164|SUPERIORITY||Risk Ratio (RR)|0.77|||||TWO_SIDED|95.0|0.47|1.27|||||Adjusted for infertility treatment stratum and study site.|"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. Gestational diabetes will be compared using two sided tests conducted at the 0.05 level."||1.27|0.47|
72379062|NCT01857310|144266165|SUPERIORITY||Risk Difference (RD)|1.2|||||TWO_SIDED|95.0|-1.4|3.8|||||Adjusted for infertility treatment stratum and study site.|"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. Cesarean delivery will be compared using two sided tests conducted at the 0.05 level."||3.8|-1.4|
72379063|NCT01857310|144266165|SUPERIORITY||Risk Ratio (RR)|1.12|||||TWO_SIDED|95.0|0.89|1.39|||||Adjusted for infertility treatment stratum and study site.|"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. Cesarean delivery will be compared using two sided tests conducted at the 0.05 level."||1.39|0.89|
72379064|NCT01857310|144266166|SUPERIORITY||Risk Difference (RD)|1.9|||||TWO_SIDED|95.0|0.2|3.6|||||Adjusted for infertility treatment stratum and study site.|"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. Preterm delivery will be compared using two sided tests conducted at the 0.05 level."||3.6|0.2|
72379065|NCT01857310|144266166|SUPERIORITY||Risk Ratio (RR)|1.49|||||TWO_SIDED|95.0|1.04|2.16|||||Adjusted for infertility treatment stratum and study site.|"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. Preterm delivery will be compared using two sided tests conducted at the 0.05 level."||2.16|1.04|
72379066|NCT01857310|144266167|SUPERIORITY||Risk Difference (RD)|0.3|||||TWO_SIDED|95.0|-1.5|2.0|||||Adjusted for infertility treatment stratum and study site.|"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. Small for gestational age will be compared using two sided tests conducted at the 0.05 level."||2.0|-1.5|
72379067|NCT01857310|144266167|SUPERIORITY||Risk Ratio (RR)|1.05|||||TWO_SIDED|95.0|0.75|1.49|||||Adjusted for infertility treatment stratum and study site.|"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. Small for gestational age will be compared using two sided tests conducted at the 0.05 level."||1.49|0.75|
72379068|NCT01857310|144266168|SUPERIORITY||Risk Difference (RD)|-0.2|||||TWO_SIDED|95.0|-0.5|0.1|||||Adjusted for infertility treatment stratum and study site.|"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. Gestational age will be compared using two sided tests conducted at the 0.05 level."||0.1|-0.5|
72379069|NCT01857310|144266169|SUPERIORITY||Risk Difference (RD)|-64.7|||||TWO_SIDED|95.0|-156.0|26.4|||||Adjusted for infertility treatment stratum and study site.|"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. Birth weight will be compared using two sided tests conducted at the 0.05 level."||26.4|-156|
72379070|NCT01857310|144266170|SUPERIORITY||Risk Difference (RD)|-0.2|||||TWO_SIDED|95.0|-0.6|0.1|||||Adjusted for infertility treatment stratum and study site.|"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. Stillbirth will be compared using two sided tests conducted at the 0.05 level."||0.1|-0.6|
72379071|NCT01857310|144266170|SUPERIORITY||Risk Ratio (RR)|0.25|||||TWO_SIDED|95.0|0.03|2.24|||||Adjusted for infertility treatment stratum and study site.|"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. Stillbirth will be compared using two sided tests conducted at the 0.05 level."||2.24|0.03|
72618519|NCT01026038|144768103|SUPERIORITY_OR_OTHER||GMC ratio|0.87|||||TWO_SIDED|95.0|0.62|1.23||||||Serotype 3: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.23|0.62|
72379072|NCT01857310|144266171|SUPERIORITY||Risk Difference (RD)|0.1|||||TWO_SIDED|95.0|-0.3|0.5|||||Adjusted for infertility treatment stratum and study site.|"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. Neonatal mortality will be compared using two sided tests conducted at the 0.05 level."||0.5|-0.3|
72379073|NCT01857310|144266171|SUPERIORITY||Risk Ratio (RR)|1.5|||||TWO_SIDED|95.0|0.25|8.95|||||Adjusted for infertility treatment stratum and study site.|"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. Neonatal mortality will be compared using two sided tests conducted at the 0.05 level."||8.95|0.25|
72379074|NCT01857310|144266172|SUPERIORITY||Risk Difference (RD)|0.1|||||TWO_SIDED|95.0|-0.2|0.4|||||Adjusted for infertility treatment stratum and study site.|"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. Major neonatal complications will be compared using two sided tests conducted at the 0.05 level."||0.4|-0.2|
72379075|NCT01857310|144266172|SUPERIORITY||Risk Ratio (RR)|1.99|||||TWO_SIDED|95.0|0.18|21.9|||||Adjusted for infertility treatment stratum and study site.|"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. Major neonatal complications will be compared using two sided tests conducted at the 0.05 level."||21.9|0.18|
72379076|NCT01857310|144266173|SUPERIORITY||Risk Difference (RD)|0.1|||||TWO_SIDED|95.0|-0.8|1.0|||||Adjusted for infertility treatment stratum and study site.|"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. Structural malformations will be compared using two sided tests conducted at the 0.05 level."||1.0|-0.8|
72379077|NCT01857310|144266173|SUPERIORITY||Risk Ratio (RR)|1.08|||||TWO_SIDED|95.0|0.53|2.21|||||Adjusted for infertility treatment stratum and study site.|"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. Structural malformations will be compared using two sided tests conducted at the 0.05 level."||2.21|0.53|
72379078|NCT01857310|144266174|SUPERIORITY||Risk Difference (RD)|0.4|||||TWO_SIDED|95.0|-0.4|1.3|||||Adjusted for infertility treatment stratum and study site.|"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. Severe maternal morbidity will be compared using two sided tests conducted at the 0.05 level."||1.3|-0.4|
72379079|NCT01857310|144266174|SUPERIORITY||Risk Ratio (RR)|1.5|||||TWO_SIDED|95.0|0.68|3.32|||||Adjusted for infertility treatment stratum and study site.|"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. Severe maternal morbidity will be compared using two sided tests conducted at the 0.05 level."||3.32|0.68|
72379080|NCT01857310|144266175|SUPERIORITY||Mean Difference (Final Values)|-2.34|||||TWO_SIDED|95.0|-7.9|3.23||||||"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. Fertilization rate will be compared using generalized estimating equations accounting for multiple cycles per couple."||3.23|-7.90|
72379081|NCT01857310|144266176|SUPERIORITY||Mean Difference (Final Values)|-0.11|||||TWO_SIDED|95.0|-0.33|0.11||||||"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. Number of good quality embryos will be compared using Poisson regression with generalized estimating equations accounting for multiple cycles per couple."||0.11|-0.33|
72379082|NCT01857310|144266177|SUPERIORITY||Mean Difference (Final Values)|-1.31|||||TWO_SIDED|95.0|-6.66|4.05||||||"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. Proportion of good quality embryos on day 5 will be compared using generalized estimating equations accounting for multiple cycles per couple."||4.05|-6.66|
72379083|NCT01857310|144266178|SUPERIORITY||Mean Difference (Final Values)|-0.01|||||TWO_SIDED|95.0|-0.11|0.1||||||"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. Number of embryos transferred will be compared using Poisson regression with generalized estimating equations accounting for multiple cycles per couple."||0.10|-0.11|
72379084|NCT01857310|144266179|SUPERIORITY||Mean Difference (Final Values)|-0.02|||||TWO_SIDED|95.0|-0.23|0.18||||||"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. Number of embryos cryopreserved will be compared using Poisson regression with generalized estimating equations accounting for multiple cycles per couple."||0.18|-0.23|
72379085|NCT01857310|144266180|SUPERIORITY||Mean Difference (Final Values)|-12.1|||||TWO_SIDED|95.0|-45.4|21.2||||||"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. Sperm penetration percentage will be compared using generalized estimating equations accounting for multiple cycles per couple."||21.2|-45.4|
72618520|NCT01026038|144768103|SUPERIORITY_OR_OTHER||GMC ratio|0.77|||||TWO_SIDED|95.0|0.52|1.15||||||Serotype 3: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.15|0.52|
72379086|NCT01857310|144266181|SUPERIORITY||Mean Difference (Final Values)|-0.07|||||TWO_SIDED|95.0|-0.16|0.03||||||"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. Number of cells on day 3 will be compared with Poisson regression using generalized estimating equations accounting for multiple embryos per cycle and multiple cycles per couple."||0.03|-0.16|
72379087|NCT01857310|144266182|SUPERIORITY||Risk Ratio (RR)|1.19|||||TWO_SIDED|95.0|0.88|1.61|||||Fewer than 4 cells|"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. Number of cells on day 3 will be compared using generalized estimating equations accounting for multiple embryos per cycle and multiple cycles per couple."||1.61|0.88|
72379088|NCT01857310|144266183|SUPERIORITY||Risk Ratio (RR)|1.05|||||TWO_SIDED|95.0|0.77|1.43|||||Fewer than 8 cells|"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. Number of cells on day 5 will be compared using generalized estimating equations accounting for multiple embryos per cycle and multiple cycles per couple."||1.43|0.77|
72379089|NCT01857310|144266184|SUPERIORITY||Risk Ratio (RR)|0.98|||||TWO_SIDED|95.0|0.87|1.09|||||Excellent or good morphology|"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. Embryo morphology on day 3 will be compared using generalized estimating equations accounting for multiple embryos per cycle and multiple cycles per couple."||1.09|0.87|
72379090|NCT01857310|144266185|SUPERIORITY||Risk Ratio (RR)|0.82|||||TWO_SIDED|95.0|0.63|1.06|||||Excellent or good morphology|"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. Embryo morphology on day 5 will be compared using generalized estimating equations accounting for multiple embryos per cycle and multiple cycles per couple."||1.06|0.63|
72379091|NCT01857310|144266186|SUPERIORITY||Risk Ratio (RR)|0.93|||||TWO_SIDED|95.0|0.8|1.09|||||ICSI|"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. Method of fertilization will be compared using generalized estimating equations accounting for multiple embryos per cycle and multiple cycles per couple."||1.09|0.80|
72379092|NCT01857310|144266187|SUPERIORITY||Risk Ratio (RR)|1.03|||||TWO_SIDED|95.0|0.88|1.21|||||Excellent or good quality|"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. Quality of embryos transferred will be compared using generalized estimating equations accounting for multiple embryos per cycle and multiple cycles per couple."||1.21|0.88|
72379093|NCT01857310|144266188|SUPERIORITY||Risk Ratio (RR)|2.35|||||TWO_SIDED|95.0|0.74|7.43|||||Abnormal|"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. Chromosomal complement will be compared using generalized estimating equations accounting for multiple cycles per couple."||7.43|0.74|
72379094|NCT02757950|144266199|OTHER|The comparison of the relative risk with its two sided 95% CI of each primary endpoint between the Exposed cohort and the Unexposed cohort was obtained by means of logistic regression model, using the exposure status as a binary independent variable in the model. Absence of increased relative risk was concluded if the respective 95% CI contained 1.|Incidence rate ratio|0.548||||0.1147|TWO_SIDED|95.0|0.259|1.157||A multiple logistic regression model was fitted with a backward selection to identify the possible confounding factors for each of the primary safety event using an alpha level of 0.1.|Regression, Logistic|||The analysis contained only the subjects with vaccination date in the Exposed cohort and subjects from the Unexposed cohort.||1.157|0.259|0.1147
72379095|NCT02757950|144266200|OTHER|The comparison of the relative risk with its two sided 95% CI of each primary endpoint between the Exposed cohort and the Unexposed cohort was obtained by means of logistic regression model, using the exposure status as a binary independent variable in the model. Absence of increased relative risk was concluded if the respective 95% CI contained 1.|Incidence rate ratio|0.428||||0.0155|TWO_SIDED|95.0|0.215|0.851||A multiple logistic regression model was fitted with a backward selection to identify the possible confounding factors for each of the primary safety event using an alpha level of 0.1.|Regression, Logistic|||The analysis contained only the subjects with vaccination date in the Exposed cohort and subjects from the Unexposed cohort.||0.851|0.215|0.0155
72379096|NCT02757950|144266201|OTHER|The comparison of the relative risk with its two sided 95% CI of each primary endpoint between the Exposed cohort and the Unexposed cohort was obtained by means of logistic regression model, using the exposure status as a binary independent variable in the model. Absence of increased relative risk was concluded if the respective 95% CI contained 1.|Incidence rate ratio|0.254||||0.0127|TWO_SIDED|95.0|0.086|0.746||A multiple logistic regression model was fitted with a backward selection to identify the possible confounding factors for each of the primary safety event using an alpha level of 0.1.|Regression, Logistic|||The analysis contained only the subjects with vaccination date in the Exposed cohort and subjects from the Unexposed cohort.||0.746|0.086|0.0127
72556321|NCT00862563|144643980|SUPERIORITY_OR_OTHER||Difference between least squares means|-20.7|STANDARD_ERROR_OF_MEAN|10.0||0.04|TWO_SIDED|||||p\< 0.05 is considered to be significant|ANOVA|||Comparison of Week 10 means for mean percent heavy drinking days obtained for the placebo and levetiracetam groups Means used for the analysis are least squares means from a two-way repeated measures mixed models analysis, with Week (time) as the the within subject factor and treatment as the between group factor. Baseline values were used as covariates.||||0.04
72618521|NCT01026038|144768103|SUPERIORITY_OR_OTHER||GMC ratio|3.49|||||TWO_SIDED|95.0|2.68|4.54||||||Serotype 5: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||4.54|2.68|
72379097|NCT02757950|144266202|OTHER|The comparison of the relative risk with its two sided 95% CI of each primary endpoint between the Exposed cohort and the Unexposed cohort was obtained by means of logistic regression model, using the exposure status as a binary independent variable in the model. Absence of increased relative risk was concluded if the respective 95% CI contained 1.|Incidence rate ratio|0.638||||0.0036|TWO_SIDED|95.0|0.471|0.863||A multiple logistic regression model was fitted with a backward selection to identify the possible confounding factors for each of the primary safety event using an alpha level of 0.1.|Regression, Logistic|||The analysis contained only the subjects with vaccination date in the Exposed cohort and subjects from the Unexposed cohort.||0.863|0.471|0.0036
72379098|NCT02757950|144266203|OTHER|The comparison of the relative risk with its two sided 95% CI of each primary endpoint between the Exposed cohort and the Unexposed cohort was obtained by means of logistic regression model, using the exposure status as a binary independent variable in the model. Absence of increased relative risk was concluded if the respective 95% CI contained 1.|Incidence rate ratio|1.342||||0.0931|TWO_SIDED|95.0|0.952|1.89||A multiple logistic regression model was fitted with a backward selection to identify the possible confounding factors for each of the primary safety event using an alpha level of 0.1.|Regression, Logistic|||The analysis contained only the subjects with vaccination date in the Exposed cohort and subjects from the Unexposed cohort.||1.890|0.952|0.0931
72379099|NCT00930982|144266222|SUPERIORITY_OR_OTHER||Difference in Least square means|-2.368|STANDARD_ERROR_OF_MEAN|2.674|<|0.001||||||p-value should be \< 0.023 (one-sided) for a significant result as an interim analysis was performed. Results based on the no-interaction model which was defined as primary analysis.|ANCOVA|Baseline cfu was covariate, treatment and pooled centers factors. As the p-value for interaction was 0.214, the no-interaction model is appropriate.|Least square mean Ciprofloxacin minus placebo|"Ho: CFU(EOT\|Cipro) - CFU(baseline\|Cipro) \> CFU(EOT\|Placebo) - CFU(baseline\|Placebo) CFU = colony forming units EOT=End of treatment (Day 29) Sample size was based a difference of 1.2 log10 CFU/g between placebo and Ciprofloxacin and a standard deviation of 2 log10 CFU/g"||||< 0.001
72379100|NCT00645788|144266311|SUPERIORITY_OR_OTHER|||||||0.076|||||||ANCOVA|||"Ho: \|Cipro 32.5 mg - matching placebo\|=0 and \|Cipro 48.75 mg - matching placebo\|=0"||||0.076
72379101|NCT00645788|144266313|SUPERIORITY_OR_OTHER|||||||0.068|||||||ANCOVA|||"At visit 7 (End of treatment) Ho: \|Cipro 32.5 - matching placebo\| =0 and~\|Cipro 48.75 - matching placebo\| =0"||||0.068
72379102|NCT03149848|144266323|OTHER||Ratio|0.786|||||TWO_SIDED|90.0|0.743|0.831||||||||0.831|0.743|
72379103|NCT03149848|144266324|OTHER||Ratio|0.825|||||TWO_SIDED|90.0|0.761|0.895||||||||0.895|0.761|
72379104|NCT03149848|144266325|OTHER||Ratio|0.738|||||TWO_SIDED|90.0|0.702|0.776||||||||0.776|0.702|
72379105|NCT03149848|144266328|OTHER||Ratio|1.272|||||TWO_SIDED|90.0|1.204|1.345||||||||1.345|1.204|
72379106|NCT01244490|144266346|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Mean|-8.9|||<|0.001|TWO_SIDED|95.0|-11.9|-5.8|||ANCOVA|||||-5.8|-11.9|<0.001
72379107|NCT01244490|144266346|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Mean|-3.8||||0.017|TWO_SIDED|95.0|-6.8|-0.7|||ANCOVA|||||-0.7|-6.8|0.017
72379108|NCT01244490|144266347|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentage Improvement|23.7|||<|0.001|TWO_SIDED|95.0|11.1|36.4|||Cochran-Mantel-Haenszel|||||36.4|11.1|<0.001
72379109|NCT01244490|144266347|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentage Improvement|12.1||||0.024|TWO_SIDED|95.0|-0.9|25.1|||Cochran-Mantel-Haenszel|||||25.1|-0.9|0.024
72379110|NCT01244490|144266348|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Mean|-0.217||||0.003|TWO_SIDED|95.0|-0.358|-0.076|||ANCOVA|||||-0.076|-0.358|0.003
72379111|NCT01244490|144266348|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Mean|-0.162||||0.026|TWO_SIDED|95.0|-0.305|-0.019|||ANCOVA|||||-0.019|-0.305|0.026
72379112|NCT01244490|144266349|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Mean|-0.209||||0.006|TWO_SIDED|95.0|-0.358|-0.059|||ANCOVA|||||-0.059|-0.358|0.006
72379113|NCT01244490|144266349|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Mean|-0.09||||0.242|TWO_SIDED|95.0|-0.241|0.061|||ANCOVA|||||0.061|-0.241|0.242
72618522|NCT01026038|144768103|SUPERIORITY_OR_OTHER||GMC ratio|0.52|||||TWO_SIDED|95.0|0.4|0.68||||||Serotype 5: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||0.68|0.40|
72379114|NCT01244490|144266350|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||Nominal p-value uncorrected for multiplicity.|Cochran-Mantel-Haenszel|||||||<0.001
72379115|NCT01244490|144266350|SUPERIORITY_OR_OTHER_LEGACY|||||||0.196||||||Nominal p-value uncorrected for multiplicity.|Cochran-Mantel-Haenszel|||||||0.196
72379116|NCT01244490|144266352|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.165||||0.001|TWO_SIDED|95.0|-0.266|-0.064||Nominal p-value uncorrected for multiplicity.|ANCOVA|||||-0.064|-0.266|0.001
72379117|NCT01244490|144266352|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.104||||0.048|TWO_SIDED|95.0|-0.207|-0.001||Nominal p-value uncorrected for multiplicity.|ANCOVA|||||-0.001|-0.207|0.048
72379118|NCT01244490|144266353|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Mean|-0.211||||0.043|TWO_SIDED|95.0|-0.416|-0.007||Nominal p-value uncorrected for multiplicity.|ANCOVA|||||-0.007|-0.416|0.043
72379119|NCT01244490|144266353|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Mean|-0.125||||0.231|TWO_SIDED|95.0|-0.331|0.08||Nominal p-value uncorrected for multiplicity.|ANCOVA|||||0.080|-0.331|0.231
72379120|NCT01244490|144266354|SUPERIORITY_OR_OTHER_LEGACY||Diiference in Least Squares Mean|-0.229|||<|0.001|TWO_SIDED|95.0|-0.364|-0.094||Nominal p-value uncorrected for multiplicity.|ANCOVA|||||-0.094|-0.364|<0.001
72379121|NCT01244490|144266354|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Mean|-0.181||||0.009|TWO_SIDED|95.0|-0.317|-0.045||Nominal p-value uncorrected for multiplicity.|ANCOVA|||||-0.045|-0.317|0.009
72379122|NCT01244490|144266355|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Mean|-0.094||||0.096|TWO_SIDED|95.0|-0.204|0.017||Nominal p-value uncorrected for multiplicity.|ANCOVA|||||0.017|-0.204|0.096
72379123|NCT01244490|144266355|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Mean|-0.067||||0.242|TWO_SIDED|95.0|-0.18|0.046||Nominal p-value uncorrected for multiplicity.|ANCOVA|||||0.046|-0.180|0.242
72379124|NCT01244490|144266356|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Mean|-0.049||||0.5|TWO_SIDED|95.0|-0.191|0.094||Nominal p-value uncorrected for multiplicity.|ANCOVA|||||0.094|-0.191|0.500
72379125|NCT01244490|144266356|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Mean|-0.078||||0.288|TWO_SIDED|95.0|-0.222|0.066||Nominal p-value uncorrected for multiplicity.|ANCOVA|||||0.066|-0.222|0.288
72379126|NCT01244490|144266357|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Mean|-0.233||||0.001|TWO_SIDED|95.0|-0.374|-0.092||Nominal p-value uncorrected for multiplicity.|ANCOVA|||||-0.092|-0.374|0.001
72379127|NCT01244490|144266357|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Mean|-0.111||||0.124|TWO_SIDED|95.0|-0.253|0.031||Nominal p-value uncorrected for multiplicity.|ANCOVA|||||0.031|-0.253|0.124
72379128|NCT01244490|144266358|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Mean|-0.056||||0.139|TWO_SIDED|95.0|-0.131|0.018||Nominal p-value uncorrected for multiplicity.|ANCOVA|||||0.018|-0.131|0.139
72379129|NCT01244490|144266358|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Mean|-0.039||||0.315|TWO_SIDED|95.0|-0.115|0.037||Nominal p-value uncorrected for multiplicity.|ANCOVA|||||0.037|-0.115|0.315
72379130|NCT00971620|144266365|SUPERIORITY_OR_OTHER||Hodges-Lehmann|0.0||||0.7|TWO_SIDED|95.0|-2.0|4.0|||Wilcoxon rank sum test|||||4.00|-2.00|.70
72556322|NCT00862563|144643980|SUPERIORITY_OR_OTHER||Difference between least squares means|-23.3|STANDARD_ERROR_OF_MEAN|10.2||0.025|TWO_SIDED|||||p\< 0.05 is considered to be significant|ANOVA|||Comparison of Week 11 means for mean percent heavy drinking days obtained for the placebo and levetiracetam groups Means used for the analysis are least squares means from a two-way repeated measures mixed models analysis, with Week (time) as the the within subject factor and treatment as the between group factor. Baseline values were used as covariates.||||0.025
72379131|NCT00971620|144266367|SUPERIORITY_OR_OTHER|||||||0.06|||||||Wilcoxon rank sum test|||||||.06
72379132|NCT00971620|144266368|SUPERIORITY_OR_OTHER|||||||0.007|||||||WIlcoxon rank sum test|||||||.007
72379133|NCT00971620|144266369|SUPERIORITY_OR_OTHER|||||||0.48|||||||Wilcoxon rank sum test|||||||0.48
72379134|NCT00971620|144266370|SUPERIORITY_OR_OTHER|||||||0.04|||||||Wilcoxon rank sum test|||||||.04
72379135|NCT00971620|144266372|SUPERIORITY_OR_OTHER|||||||0.07|||||||Wilcoxon rank sum test|||||||.07
72379136|NCT02581943|144266386|OTHER|||||||0.366|||||||Log Rank|||||||0.366
72379137|NCT02581943|144266387|EQUIVALENCE|Null hypothesis: no difference between treatment arms in the post-pre difference in cell counts.||||||0.327|||||||Wilcoxon (Mann-Whitney)|test for CD4+FoxP3||||||0.327
72379138|NCT02581943|144266387|EQUIVALENCE|Null hypothesis: no difference between treatment arms in the post-pre difference in cell counts.||||||0.142|||||||Wilcoxon (Mann-Whitney)|test for MDSC||||||0.142
72379139|NCT02581943|144266387|EQUIVALENCE|Null hypothesis: no difference between treatment arms in the post-pre difference in cell counts.||||||0.462||||||test for CD4+ICOS+|Wilcoxon (Mann-Whitney)|||||||0.462
72379140|NCT02581943|144266387|EQUIVALENCE|Null hypothesis: no difference between treatment arms in the post-pre difference in cell counts.||||||0.87||||||test for CD8+ICOS+|Wilcoxon (Mann-Whitney)|||||||0.870
72379141|NCT02581943|144266387|EQUIVALENCE|Null hypothesis: no difference between treatment arms in the post-pre difference in cell counts.||||||0.414||||||test for Plamacytoid DC|Wilcoxon (Mann-Whitney)|||||||0.414
72379142|NCT02581943|144266387|EQUIVALENCE|Null hypothesis: no difference between treatment arms in the post-pre difference in cell counts.||||||0.121||||||test for Monocytes|Wilcoxon (Mann-Whitney)|||||||0.121
72379143|NCT02581943|144266387|EQUIVALENCE|Null hypothesis: no difference between treatment arms in the post-pre difference in cell counts.||||||0.624||||||test for T cells (CD3+)|Wilcoxon (Mann-Whitney)|||||||0.624
72379144|NCT02581943|144266388|OTHER|||||||0.348|||||||Fisher Exact|||||||0.348
72618523|NCT01026038|144768103|SUPERIORITY_OR_OTHER||GMC ratio|0.15|||||TWO_SIDED|95.0|0.11|0.2||||||Serotype 5: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||0.20|0.11|
72379145|NCT02581943|144266389|OTHER|||||||0.63|||||||Log Rank|||||||0.63
72379146|NCT02581943|144266390|OTHER|||||||0.692|||||||Log Rank|||||||0.692
72379147|NCT02581943|144266391|OTHER|||||||0.345|||||||Fisher Exact|||||||0.345
72379148|NCT02581943|144266392|OTHER|||||||0.917|||||||Kruskal-Wallis|Test for CD8+ICOS||||||0.917
72379149|NCT02581943|144266392|OTHER|||||||0.746|||||||Kruskal-Wallis|test for MDSC||||||0.746
72379150|NCT02581943|144266392|OTHER|||||||0.302||||||test for CD4+ICOS|Kruskal-Wallis|||||||0.302
72379151|NCT02581943|144266392|OTHER|||||||0.13|||||||Kruskal-Wallis|test for CD8+ICOS+||||||0.130
72379152|NCT02581943|144266392|OTHER|||||||0.628||||||test for Plamacytoid DC|Kruskal-Wallis|||||||0.628
72379153|NCT02581943|144266392|OTHER|||||||0.567||||||test for Monocytes|Kruskal-Wallis|||||||0.567
72379154|NCT02581943|144266392|OTHER|||||||0.311||||||test for T cells (CD3+)|Kruskal-Wallis|||||||0.311
72379155|NCT02380690|144266453|SUPERIORITY|ECLIPSE was powered to detect an effect size of 0.45.||||||0.981||||||Statistical significance was set at p\<0.05|Regression, Linear|||||||0.981
72379156|NCT02380690|144266454|SUPERIORITY|||||||0.774|||||||Regression, Linear|||||||0.774
72379157|NCT02380690|144266455|SUPERIORITY|Power was based on primary outcome.||||||0.999||||||Statistical significance was set at p\<0.05. A Sidak adjustment was used to account for multiple comparisons. Unadjusted p-value = 0.546.|Regression, Linear|||||||0.999
72379158|NCT02380690|144266456|SUPERIORITY|||||||0.999||||||Statistical significance was set at p\<0.05. A Sidak adjustment was used to account for multiple comparisons. Unadjusted p-value = 0.403.|Regression, Linear|||||||0.999
72379159|NCT02380690|144266457|SUPERIORITY|||||||0.999||||||Statistical significance was set at p\<0.05. A Sidak adjustment was used to account for multiple comparisons. Unadjusted p-value = 0.452.|Regression, Linear|||||||0.999
72379160|NCT02380690|144266458|SUPERIORITY|||||||0.98||||||Statistical significance was set at p\<0.05. A Sidak adjustment was used to account for multiple comparisons. Unadjusted p-value = 0.243.|Regression, Linear|||||||0.980
72379161|NCT02380690|144266459|SUPERIORITY|||||||0.864||||||Statistical significance was set at p\<0.05. A Sidak adjustment was used to account for multiple comparisons. Unadjusted p-value = 0.133.|Regression, Linear|||||||0.864
72379162|NCT02380690|144266460|SUPERIORITY|||||||0.78||||||Statistical significance was set at p\<0.05. A Sidak adjustment was used to account for multiple comparisons. Unadjusted p-value = 0.102.|Regression, Linear|||||||0.780
72379163|NCT02380690|144266461|SUPERIORITY|||||||0.999||||||Statistical significance was set at p\<0.05. A Sidak adjustment was used to account for multiple comparisons. Unadjusted p-value = 0.536.|Regression, Linear|||||||0.999
72379164|NCT02380690|144266462|SUPERIORITY|||||||0.997||||||Statistical significance was set at p\<0.05. A Sidak adjustment was used to account for multiple comparisons. Unadjusted p-value = 0.340.|Regression, Linear|||||||0.997
72379165|NCT02380690|144266463|SUPERIORITY|||||||0.999||||||Statistical significance was set at p\<0.05. A Sidak adjustment was used to account for multiple comparisons. Unadjusted p-value = 0.384.|Regression, Linear|||||||0.999
72379166|NCT02380690|144266464|SUPERIORITY|||||||0.999||||||Statistical significance was set at p\<0.05. A Sidak adjustment was used to account for multiple comparisons. Unadjusted p-value = 0.730.|Regression, Linear|||||||0.999
72379167|NCT02380690|144266465|SUPERIORITY|||||||0.914||||||Statistical significance was set at p\<0.05. A Sidak adjustment was used to account for multiple comparisons. Unadjusted p-value = 0.161.|Regression, Linear|||||||0.914
72379168|NCT02380690|144266466|SUPERIORITY|||||||0.999||||||Statistical significance was set at p\<0.05. A Sidak adjustment was used to account for multiple comparisons. Unadjusted p-value = 0.930.|Regression, Linear|||||||0.999
72379169|NCT02380690|144266467|SUPERIORITY|||||||0.999||||||Statistical significance was set at p\<0.05. A Sidak adjustment was used to account for multiple comparisons. Unadjusted p-value = 0.379.|Regression, Linear|||||||0.999
72379170|NCT02380690|144266468|SUPERIORITY|||||||0.999||||||Statistical significance was set at p\<0.05. A Sidak adjustment was used to account for multiple comparisons. Unadjusted p-value = 0.969.|Regression, Linear|||||||0.999
72433617|NCT00991276|144380374|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-2.45|STANDARD_ERROR_OF_MEAN|1.3||0.0617|TWO_SIDED|95.0|-5.02|0.12||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||0.12|-5.02|0.0617
72379171|NCT00829933|144266472|SUPERIORITY_OR_OTHER|||||||0.429|TWO_SIDED||||||Chi-squared|||For the incidence of bleeding events, paired comparison between the DU-176b groups was performed using the χ2 test.||||0.429
72379172|NCT00829933|144266472|SUPERIORITY_OR_OTHER|||||||0.077|TWO_SIDED||||||Chi-squared|||||||0.077
72379173|NCT00829933|144266472|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|-1.5|||||TWO_SIDED|95.0|-11.2|8.1|||Wilcoxon (Mann-Whitney)|||||8.1|-11.2|
72379174|NCT00829933|144266472|SUPERIORITY_OR_OTHER|||||||0.32|TWO_SIDED||||||Chi-squared|||||||0.320
72379175|NCT00829933|144266472|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|2.4|||||TWO_SIDED|95.0|-7.6|12.3|||Wilcoxon (Mann-Whitney)|||||12.3|-7.6|
72379176|NCT00829933|144266472|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|7.7|||||TWO_SIDED|95.0|-2.7|18.1|||Wilcoxon (Mann-Whitney)|||||18.1|-2.7|
72379177|NCT02338336|144266478|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA|||||||<0.001
72379178|NCT01986933|144266480|SUPERIORITY||Mean Difference (Final Values)|-21.39|STANDARD_ERROR_OF_MEAN|7.02||0.0027|TWO_SIDED|95.0|-35.25|-7.53||Since a hierarchical decision procedure can be regarded as a closed testing procedure, no inflation of the alpha level due to multiple comparisons was necessary, and the global 1-sided significance alpha level of 0.025 was maintained.|ANCOVA|||||-7.53|-35.25|0.0027
72379179|NCT01986933|144266480|SUPERIORITY||Mean Difference (Final Values)|-41.16|STANDARD_ERROR_OF_MEAN|7.1|<|0.0001|TWO_SIDED|95.0|-55.17|-27.15||Since a hierarchical decision procedure can be regarded as a closed testing procedure, no inflation of the alpha level due to multiple comparisons was necessary, and the global 1-sided significance alpha level of 0.025 was maintained.|ANCOVA|||||-27.15|-55.17|<0.0001
72379180|NCT01986933|144266480|SUPERIORITY||Mean Difference (Final Values)|-40.39|STANDARD_ERROR_OF_MEAN|6.95|<|0.0001|TWO_SIDED|95.0|-54.11|-26.67||Since a hierarchical decision procedure can be regarded as a closed testing procedure, no inflation of the alpha level due to multiple comparisons was necessary, and the global 1-sided significance alpha level of 0.025 was maintained.|ANCOVA|||||-26.67|-54.11|<0.0001
72379181|NCT03119701|144266489|SUPERIORITY||Odds Ratio (OR)|1.3||||0.78|TWO_SIDED|95.0|0.21|8.19||The threshold for statistical significance was p = 0.05.|Regression, Logistic|||||8.19|0.21|0.78
72379182|NCT03119701|144266490|SUPERIORITY||Odds Ratio (OR)|1.7||||0.57|TWO_SIDED|95.0|0.28|10.52||The threshold for statistical significance was p = 0.05.|Regression, Logistic|||||10.52|0.28|0.57
72379183|NCT03119701|144266491|SUPERIORITY|||||||0.08||||||The threshold for statistical significance was p = 0.05.|Wilcoxon (Mann-Whitney)|||||||0.08
72618524|NCT01026038|144768103|SUPERIORITY_OR_OTHER||GMC ratio|1.61|||||TWO_SIDED|95.0|1.15|2.23||||||Serotype 6A: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||2.23|1.15|
72379184|NCT03119701|144266493|SUPERIORITY||||||>|0.999||||||The threshold for statistical significance was p = 0.05.|Wilcoxon (Mann-Whitney)|||||||>0.999
72379185|NCT03119701|144266496|SUPERIORITY|||||||0.362||||||The threshold for statistical significance was p = 0.05.|Mantel Haenszel|Exact Mantel-Haenszel Chi-Square Test||||||0.3620
72379186|NCT03119701|144266499|SUPERIORITY||||||<|0.0001||||||Day 2, Day 3, Day 4, Day 5, and Day 6.|ANOVA|Repeated measures ANOVA||The lower limit of quantification (LLOQ) is equal 5 ng/ml. Values below the LLOQ were set to LLOQ/2 = 2.5 ng/ml. Values over the upper limit of quantitation (ULOQ) were set to 320 ng/ml.||||<.0001
72379187|NCT03119701|144266499|SUPERIORITY|||||||0.13||||||Baseline visit|ANOVA|Repeated measures ANOVA||The lower limit of quantification (LLOQ) is equal 5 ng/ml. Values below the LLOQ were set to LLOQ/2 = 2.5 ng/ml. Values over the upper limit of quantitation (ULOQ) were set to 320 ng/ml.||||0.13
72379188|NCT03119701|144266499|SUPERIORITY|||||||0.0035||||||Day 1|ANOVA|Repeated measures ANOVA||The lower limit of quantification (LLOQ) is equal 5 ng/ml. Values below the LLOQ were set to LLOQ/2 = 2.5 ng/ml. Values over the upper limit of quantitation (ULOQ) were set to 320 ng/ml.||||0.0035
72379189|NCT03119701|144266499|SUPERIORITY|||||||0.009||||||Day 9|ANOVA|Repeated measures ANOVA||The lower limit of quantification (LLOQ) is equal 5 ng/ml. Values below the LLOQ were set to LLOQ/2 = 2.5 ng/ml. Values over the upper limit of quantitation (ULOQ) were set to 320 ng/ml.||||0.009
72379190|NCT03119701|144266499|SUPERIORITY|||||||0.1||||||Day 13|ANOVA|Repeated measures ANOVA||The lower limit of quantification (LLOQ) is equal 5 ng/ml. Values below the LLOQ were set to LLOQ/2 = 2.5 ng/ml. Values over the upper limit of quantitation (ULOQ) were set to 320 ng/ml.||||0.10
72379191|NCT03119701|144266500|SUPERIORITY|||||||0.66||||||The threshold for statistical significance was p = 0.05.|ANOVA|Repeated measures ANOVA||Patients with an observation below the lower limit of quantification (LLOQ) value at baseline for CD73 were set to have the LLOQ value (LLOQ = 4 ng/ml) at baseline for subgroup determination purposes (2-fold increase in CD73 from baseline). Values below the LLOQ were set to LLOQ/2 = 2 ng/mL.||||0.66
72379192|NCT03119701|144266501|SUPERIORITY|||||||0.3||||||The threshold for statistical significance was p = 0.05.|ANOVA|Repeated measures ANOVA||Observations of zero were imputed as 1 pg/ml before logarithmic transformation.||||0.3
72379193|NCT04480424|144266538|SUPERIORITY||Risk Difference|-4.0||||0.8275|TWO_SIDED|95.0|-22.3|14.5||p-value was calculated using Fisher's exact method with 5% level of significance to test the null hypothesis of no difference in mortality rate between the two treatment groups.|Fisher Exact|||||14.5|-22.3|0.8275
72379194|NCT04480424|144266539|SUPERIORITY|||||||0.8599||||||p-value was calculated using Gray's test for equality of the Cumulative Incidence Function (CIF) between treatment groups.|Gray's test|||||||0.8599
72379195|NCT04480424|144266540|SUPERIORITY||Least Square Mean (LSM) Difference|2.58||||0.2626|TWO_SIDED|95.0|-1.96|7.12||p-value was calculated using an Analysis of Variance (ANOVA) model, including the number of days on mechanical ventilation as a dependent variable and treatment group as a fixed effect.|ANOVA|||||7.12|-1.96|0.2626
72379196|NCT04480424|144266541|SUPERIORITY|||||||0.6854||||||p-value was calculated using Gray's test for equality of the CIF between treatment groups.|Gray's test|||||||0.6854
72379197|NCT04480424|144266542|SUPERIORITY||LSM Difference|-0.02||||0.9917|TWO_SIDED|95.0|-3.82|3.78||95% CI for difference in least square mean (LSM) between treatment groups and the associated p-value were calculated using an ANOVA model, including the number of days on oxygen as a dependent variable and treatment group as a fixed effect.|ANOVA|||||3.78|-3.82|0.9917
72379198|NCT04480424|144266543|SUPERIORITY||LSM Difference|0.05||||0.7557|TWO_SIDED|95.0|-0.29|0.4|||Kenward-Roger|p-value were calculated using restricted maximum likelihood with the Kenward-Roger method for calculating the denominator degrees of freedom.||||0.40|-0.29|0.7557
72379199|NCT04480424|144266544|SUPERIORITY||LSM Difference|0.4||||0.0922|TWO_SIDED|95.0|-0.07|0.86||p-value were calculated using restricted maximum likelihood with the Kenward-Roger method for calculating the denominator degrees of freedom.|Kenward-Roger|||||0.86|-0.07|0.0922
72379200|NCT04480424|144266548|SUPERIORITY||Kenward-Roger|0.4||||0.3611|TWO_SIDED|95.0|-0.47|1.28||p-value was calculated using restricted maximum likelihood with the Kenward-Roger method for calculating the denominator degrees of freedom.|LSM Difference|||||1.28|-0.47|0.3611
72379201|NCT04480424|144266548|SUPERIORITY||Kenward-Roger|-0.1||||0.9238|TWO_SIDED|95.0|-2.13|1.94||p-value was calculated using restricted maximum likelihood with the Kenward-Roger method for calculating the denominator degrees of freedom.|LSM Difference|||||1.94|-2.13|0.9238
72433618|NCT00991276|144380374|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-6.35|STANDARD_ERROR_OF_MEAN|1.29|<|0.0001|TWO_SIDED|95.0|-8.91|-3.8||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||-3.80|-8.91|<0.0001
72379202|NCT04480424|144266548|SUPERIORITY||Kenward-Roger|0.08||||0.9541|TWO_SIDED|95.0|-2.58|2.73||p-value was calculated using restricted maximum likelihood with the Kenward-Roger method for calculating the denominator degrees of freedom.|LSM Difference|||||2.73|-2.58|0.9541
72379203|NCT04480424|144266549|SUPERIORITY||LSM Difference|0.06||||0.9366|TWO_SIDED|95.0|-1.42|1.53||p-value was calculated using restricted maximum likelihood with the Kenward-Roger method for calculating the denominator degrees of freedom.|LSM Difference|||||1.53|-1.42|0.9366
72379204|NCT00734747|144266582|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<.001
72379205|NCT03150485|144266640|SUPERIORITY|Superiority was established is the lower limit of the 95% confidence interval was above 50%.|Estimated Proportion|77.27|||||TWO_SIDED|95.0|56.15|90.29|||Agresti-Coull|||The Agresti-Coull method was used to estimate the confidence interval of the binomial proportions of subjects with less than 2 lens modifications.||90.29|56.15|
72379206|NCT00472459|144266673|NON_INFERIORITY|Participant's number of new skin lesions between treated and contralateral control area were evaluated using a paired t-test for lesions of any type as well as stratified by lesion type.|Mean Difference (Final Values)|0.514||||0.012|TWO_SIDED|95.0|0.116|0.911|||t-test, 2 sided||The 95 % confidence intervals for the lesion complete response rates and lesion recurrence rates were estimated using the method of Clopper and Pearson.|||0.911|0.116|0.0120
72379207|NCT00472459|144266674|NON_INFERIORITY|Participant's number of new skin lesions between treated and contralateral control area were evaluated using a paired t-test for lesions of any type as well as stratified by lesion type.|Mean Difference (Final Values)|0.413||||0.1761|TWO_SIDED|95.0|-0.19|1.016|||t-test, 2 sided|||||1.016|-0.190|0.1761
72379208|NCT00472459|144266675|NON_INFERIORITY|Participant's number of new skin lesions between treated and contralateral control area were evaluated using a paired t-test for lesions of any type as well as stratified by lesion type.|Mean Difference (Final Values)|0.6||||0.1183|TWO_SIDED|95.0|-0.156|1.357|||t-test, 2 sided|||||1.357|-0.156|0.1183
72556323|NCT00862563|144643980|SUPERIORITY_OR_OTHER||Difference between least squares means|-24.8|STANDARD_ERROR_OF_MEAN|10.3||0.018|TWO_SIDED|||||p\<0.05 is considered to be significant|ANOVA|||Comparison of Week 12 means for mean percent heavy drinking days obtained for the placebo and levetiracetam groups Means used for the analysis are least squares means from a two-way repeated measures mixed models analysis, with Week (time) as the the within subject factor and treatment as the between group factor. Baseline values were used as covariates.||||0.018
72379209|NCT00472459|144266676|NON_INFERIORITY|Participant's number of new skin lesions between treated and contralateral control area were evaluated using a paired t-test for lesions of any type as well as stratified by lesion type.|Mean Difference (Final Values)|0.493||||0.2322|TWO_SIDED|95.0|-0.323|1.309|||t-test, 2 sided|||||1.309|-0.323|0.2322
72379210|NCT00472459|144266677|NON_INFERIORITY|Participant's number of new skin lesions between treated and contralateral control area were evaluated using a paired t-test for lesions of any type as well as stratified by lesion type.|Mean Difference (Final Values)|0.68||||0.1286|TWO_SIDED|95.0|-0.202|1.562|||t-test, 2 sided|||||1.562|-0.202|0.1286
72379211|NCT01966692|144266763|EQUIVALENCE|Bioequivalence of the two treatments was to be concluded if the 90% CIs for the ratio of geometric means for AUC0-last fell completely within (80%, 125%).|ratio (%) of geometric means|106.0||||0.4132|TWO_SIDED|90.0|99.0|114.0||The threshold for statistical significane was p=0.05.|Mixed Models Analysis||Mean difference and the 90% CI for the difference were exponentiated to provide an estimate of the ratio of adjusted geometric means (test/reference).|"Test: Fluticasone Propionate Formulation 2 (B-3.8 µm); Reference: Fluticasone Propionate Formulation 1 (A-4.5 µm); Natural log transformed AUC0-last: mixed models analysis with sequence, period, treatment as fixed effects and subject within sequence as a random effect.~All reported p-values are Bonferroni adjusted p-values."||114|99|0.4132
72379212|NCT01966692|144266763|EQUIVALENCE|Bioequivalence of the two treatments was to be concluded if the 90% CIs for the ratio of geometric means for AUC0-last fell completely within (80%, 125%).|ratio (%) of geometric means|109.0||||0.1295|TWO_SIDED|90.0|102.0|116.0||The threshold for statistical significane was p=0.05.|Mixed Models Analysis||Mean difference and the 90% CI for the difference were exponentiated to provide an estimate of the ratio of adjusted geometric means (test/reference).|"Test: Fluticasone Propionate Formulation 3 (C-3.7 µm); Reference: Fluticasone Propionate Formulation 1 (A-4.5 µm); Natural log transformed AUC0-last: mixed models analysis with sequence, period, treatment as fixed effects and subject within sequence as a random effect.~All reported p-values are Bonferroni adjusted p-values."||116|102|0.1295
72379213|NCT01966692|144266763|EQUIVALENCE|Bioequivalence of the two treatments was to be concluded if the 90% CIs for the ratio of geometric means for AUC0-last fell completely within (80%, 125%).|ratio (%) of geometric means|114.0||||0.0078|TWO_SIDED|90.0|106.0|122.0||The threshold for statistical significane was p=0.05.|Mixed Models Analysis||Mean difference and the 90% CI for the difference were exponentiated to provide an estimate of the ratio of adjusted geometric means (test/reference).|"Test: Fluticasone Propionate Formulation 3 (C-3.7 µm)\*; Reference: Fluticasone Propionate Formulation 1 (A-4.5 µm); Natural log transformed AUC0-last: mixed models analysis with sequence, period, treatment as fixed effects and subject within sequence as a random effect.~All reported p-values are Bonferroni adjusted p-values."||122|106|0.0078
72379214|NCT01966692|144266764|EQUIVALENCE|Bioequivalence of the two treatments was to be concluded if the 90% CIs for the ratio of geometric means for Cmax fell completely within (80%, 125%).|ratio (%) of geometric means|182.0|||<|0.001|TWO_SIDED|90.0|159.0|208.0||The threshold for statistical significane was p=0.05.|Mixed Models Analysis||Mean difference and the 90% CI for the difference were exponentiated to provide an estimate of the ratio of adjusted geometric means (test/reference).|"Test: Fluticasone Propionate Formulation 2 (B-3.8 µm); Reference: Fluticasone Propionate Formulation 1 (A-4.5 µm); Natural log transformed Cmax: mixed models analysis with sequence, period, treatment as fixed effects and subject within sequence as a random effect.~All reported p-values are Bonferroni adjusted p-values."||208|159|<0.001
72379215|NCT01966692|144266764|EQUIVALENCE|Bioequivalence of the two treatments was to be concluded if the 90% CIs for the ratio of geometric means for Cmax fell completely within (80%, 125%).|ratio (%) of geometric means|190.0|||<|0.001|TWO_SIDED|90.0|166.0|217.0||The threshold for statistical significance was p=0.05.|Mixed Models Analysis||Mean difference and the 90% CI for the difference were exponentiated to provide an estimate of the ratio of adjusted geometric means (test/reference).|"Test: Fluticasone Propionate Formulation 3 (C-3.7 µm); Reference: Fluticasone Propionate Formulation 1 (A-4.5 µm); Natural log transformed Cmax: mixed models analysis with sequence, period, treatment as fixed effects and subject within sequence as a random effect.~All reported p-values are Bonferroni adjusted p-values."||217|166|<0.001
72379216|NCT01966692|144266764|EQUIVALENCE|Bioequivalence of the two treatments was to be concluded if the 90% CIs for the ratio of geometric means for Cmax fell completely within (80%, 125%).|ratio (%) of geometric means|213.0|||<|0.001|TWO_SIDED|90.0|186.0|244.0||The threshold for statistical significance was p=0.05.|Mixed Models Analysis||Mean difference and the 90% CI for the difference were exponentiated to provide an estimate of the ratio of adjusted geometric means (test/reference).|"Test: Fluticasone Propionate Formulation 3 (C-3.7 µm)\*; Reference: Fluticasone Propionate Formulation 1 (A-4.5 µm); Natural log transformed Cmax: mixed models analysis with sequence, period, treatment as fixed effects and subject within sequence as a random effect.~All reported p-values are Bonferroni adjusted p-values."||244|186|<0.001
72379217|NCT00478881|144266768|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.045||||0.5293||95.0|-33.194|17.104||Bladder volume (mL) at first detrusor contraction tested first. If significant, the change in the average number of daily micturitions was to be tested using a P\<0.05.|ANCOVA||Placebo-Vardenafil|Countries were pooled into 2 clusters, which allowed for testing of Treatment by Center interaction. An ANCOVA including Baseline (Visit 2) as a covariate with main effects for treatment and country (see pooling above) was used to test treatment difference for the primary variable and co-primary variable.||17.104|-33.194|0.5293
72379218|NCT00478881|144266769|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.668||||0.0575||95.0|-0.021|1.358||Bladder volume (mL) at first detrusor contraction tested first. If significant, the change in the average number of daily micturitions was to be tested using a P \<0.05.|ANCOVA||Placebo - Vardenafil|Countries were pooled into 2 clusters, which allowed for testing of Treatment by Center interaction. An ANCOVA including Baseline (Visit 2) as a covariate with main effects for treatment and country (see pooling above) was used to test treatment difference for the primary variable and co-primary variable.||1.358|-0.021|0.0575
72379219|NCT00478881|144266770|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.657||||0.8533||95.0|-6.335|7.65||P-values were reported as nominal values and without any adjustments for multiplicity.|ANCOVA||Placebo- Vardenafil|ANCOVA models used for the secondary efficacy variables were the models determined for the primary efficacy variable or co-primary efficacy variable depending on the type of variable.||7.650|-6.335|0.8533
72493936|NCT03178487|144516779|SUPERIORITY|To preserve the overall type I error rate at α=0.05 level, a step-down approach was used to test the primary and multiplicity-controlled key secondary endpoints. The testing began with the primary endpoint at α=0.05 and continued conditional on significance of higher-ranked endpoint. The testing sequence included a group of endpoints tested by the Hochberg procedure, including BASDAI 50; within the group, the allocated α was adjusted based on the magnitude of p values.|Response Rate Difference|21.8||||0.002|TWO_SIDED|95.0|8.5|35.0|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusting for stratification factor of Screening hsCRP level.|Response rate difference = Upadacitinib - Placebo|||35.0|8.5|0.002
72379220|NCT00478881|144266771|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.59||||0.1539||95.0|-37.057|5.876||P-values were reported as nominal values and without any adjustments for multiplicity.|ANCOVA||Placebo- Vardenafil|ANCOVA models used for the secondary efficacy variables were the models determined for the primary efficacy variable or co-primary efficacy variable depending on the type of variable.||5.876|-37.057|0.1539
72379221|NCT00478881|144266772|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.374||||0.2348||95.0|-32.834|8.087||P-values were reported as nominal values and without any adjustments for multiplicity.|ANCOVA||placebo - vardenafil|ANCOVA models used for the secondary efficacy variables were the models determined for the primary efficacy variable or co-primary efficacy variable depending on the type of variable.||8.087|-32.834|0.2348
72379222|NCT00478881|144266773|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.195||||0.3289||95.0|-24.692|8.303||P-values were reported as nominal values and without any adjustments for multiplicity.|ANCOVA||placebo - vardenafil|ANCOVA models used for the secondary efficacy variables were the models determined for the primary efficacy variable or co-primary efficacy variable depending on the type of variable.||8.303|-24.692|0.3289
72379223|NCT00478881|144266774|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.721||||0.0609||95.0|-0.033|1.476||P-values were reported as nominal values and without any adjustments for multiplicity.|ANCOVA||placebo - vardenafil|ANCOVA models used for the secondary efficacy variables were the models determined for the primary efficacy variable or co-primary efficacy variable depending on the type of variable.||1.476|-0.033|0.0609
72379224|NCT00478881|144266775|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.118||||0.4928||95.0|-0.22|0.456||P-values were reported as nominal values and without any adjustments for multiplicity.|ANCOVA||placebo - vardenafil|ANCOVA models used for the secondary efficacy variables were the models determined for the primary efficacy variable or co-primary efficacy variable depending on the type of variable.||0.456|-0.220|0.4928
72379225|NCT00478881|144266776|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.823||||0.3248||95.0|-2.476|0.829||P-values were reported as nominal values and without any adjustments for multiplicity.|ANCOVA||placebo - vardenafil|ANCOVA models used for the secondary efficacy variables were the models determined for the primary efficacy variable or co-primary efficacy variable depending on the type of variable.||0.829|-2.476|0.3248
72379226|NCT00478881|144266777|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.095||||0.5312||95.0|-4.533|2.342||P-values were reported as nominal values and without any adjustments for multiplicity.|ANCOVA|||ANCOVA models used for the secondary efficacy variables were the models determined for the primary efficacy variable or co-primary efficacy variable depending on the type of variable.||2.342|-4.533|0.5312
72379227|NCT00737464|144266779|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.52|||||TWO_SIDED|||||||||||||
72379228|NCT03569293|144266819|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 30 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|63.4|||<|0.001|TWO_SIDED|95.0|57.1|69.8|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||69.8|57.1|<0.001
72556324|NCT00862563|144643981|SUPERIORITY_OR_OTHER||Difference between least squares means|-22.5|STANDARD_ERROR_OF_MEAN|7.8||0.005|TWO_SIDED|||||p\<0.05 is considered to be significant|ANOVA|||Comparison of Week 10 means for mean percent drinking days obtained for the placebo and zonisamide groups Means used for the analysis are least squares means from a two-way repeated measures mixed models analysis, with Week (time) as the the within subject factor and treatment as the between group factor. Baseline values were used as covariates.||||0.005
72379229|NCT03569293|144266819|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 15 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|53.3|||<|0.001|TWO_SIDED|95.0|46.4|60.2|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||60.2|46.4|<0.001
72379230|NCT03569293|144266820|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 30 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|53.6|||<|0.001|TWO_SIDED|95.0|47.2|60.0|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response rate difference = Upadacitinib - Placebo|||60.0|47.2|<0.001
72379231|NCT03569293|144266820|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 15 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|39.8|||<|0.001|TWO_SIDED|95.0|33.2|46.4|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response rate difference = Upadacitinib - Placebo|||46.4|33.2|<0.001
72493937|NCT03178487|144516780|SUPERIORITY|To preserve the overall type I error rate at α=0.05 level, a step-down approach was used to test the primary and multiplicity-controlled key secondary endpoints. The testing began with the primary endpoint at α=0.05 and continued conditional on significance of higher-ranked endpoint. The testing sequence included a group of endpoints tested by the Hochberg procedure, including ASQoL; within the group, the allocated α was adjusted based on the magnitude of p values.|LS Mean Difference|-1.54||||0.016|TWO_SIDED|95.0|-2.78|-0.3|||Mixed Effect Model Repeated Measurement|MMRM model includes treatment, visit, treatment-by-visit interaction as fixed effects and Screening hsCRP level and Baseline value as covariates.|Treatment difference = Upadacitinib - Placebo|||-0.30|-2.78|0.016
72618525|NCT01026038|144768103|SUPERIORITY_OR_OTHER||GMC ratio|1.24|||||TWO_SIDED|95.0|0.89|1.72||||||Serotype 6A: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.72|0.89|
72379232|NCT03569293|144266821|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 30 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|48.2|||<|0.001|TWO_SIDED|95.0|41.3|55.0|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||55.0|41.3|<0.001
72379233|NCT03569293|144266821|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 15 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|40.5|||<|0.001|TWO_SIDED|95.0|33.5|47.5|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||47.5|33.5|<0.001
72379234|NCT03569293|144266822|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 30 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|57.8|||<|0.001|TWO_SIDED|95.0|51.5|64.1|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||64.1|51.5|<0.001
72379235|NCT03569293|144266822|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 15 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|45.1|||<|0.001|TWO_SIDED|95.0|38.6|51.7|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||51.7|38.6|<0.001
72379236|NCT03569293|144266823|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 30 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|62.3|||<|0.001|TWO_SIDED|95.0|56.3|68.3|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||68.3|56.3|<0.001
72379237|NCT03569293|144266823|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 15 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|47.1|||<|0.001|TWO_SIDED|95.0|40.7|53.4|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||53.4|40.7|<0.001
72379238|NCT03569293|144266824|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 30 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|43.9|||<|0.001|TWO_SIDED|95.0|37.7|50.0|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||50.0|37.7|<0.001
72379239|NCT03569293|144266824|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 15 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|34.5|||<|0.001|TWO_SIDED|95.0|28.6|40.5|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||40.5|28.6|<0.001
72379240|NCT03569293|144266825|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 30 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|19.2|||<|0.001|TWO_SIDED|95.0|14.6|23.9|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||23.9|14.6|<0.001
72433619|NCT00991276|144380374|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|3.9|STANDARD_ERROR_OF_MEAN|1.28||0.0028|TWO_SIDED|95.0|1.37|6.44||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||6.44|1.37|0.0028
72493938|NCT03178487|144516781|SUPERIORITY|To preserve the overall type I error rate at α=0.05 level, a step-down approach was used to test the primary and multiplicity-controlled key secondary endpoints. The testing began with the primary endpoint at α=0.05 and continued conditional on significance of higher-ranked endpoint. The testing sequence included a group of endpoints tested by the Hochberg procedure, including ASAS PR; within the group, the allocated α was adjusted based on the magnitude of p values.|Response Rate Difference|18.3|||<|0.001|TWO_SIDED|95.0|10.0|26.6|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusting for stratification factor of Screening hsCRP level.|Response rate difference = Upadacitinib - Placebo|||26.6|10.0|<0.001
72379241|NCT03569293|144266825|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 15 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|14.6|||<|0.001|TWO_SIDED|95.0|10.3|18.8|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||18.8|10.3|<0.001
72379242|NCT03569293|144266826|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 30 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|8.1|||<|0.001|TWO_SIDED|95.0|3.8|12.5|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||12.5|3.8|<0.001
72379243|NCT03569293|144266827|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 15 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|13.0|||<|0.001|TWO_SIDED|95.0|8.1|17.8|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||17.8|8.1|<0.001
72379244|NCT03569293|144266828|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 30 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|-25.2|||<|0.001|TWO_SIDED|95.0|-30.3|-20.1|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||-20.1|-30.3|<0.001
72379245|NCT03569293|144266828|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 15 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|-24.1|||<|0.001|TWO_SIDED|95.0|-29.3|-18.9|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||-18.9|-29.3|<0.001
72379246|NCT03569293|144266829|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 30 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|52.9|||<|0.001|TWO_SIDED|95.0|45.2|60.6|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||60.6|45.2|<0.001
72379247|NCT03569293|144266829|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 15 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|41.8|||<|0.001|TWO_SIDED|95.0|33.9|49.7|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||49.7|33.9|<0.001
72379248|NCT03569293|144266830|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 30 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|48.6|||<|0.001|TWO_SIDED|95.0|41.0|56.1|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||56.1|41.0|<0.001
72504868|NCT00401973|144540836|SUPERIORITY_OR_OTHER|||||||0.065||95.0||||P-value for Olanzapine versus pooled olanzapine+amantadine and olanzapine+metformin.|Mixed Models Analysis|Repeated Measures Analysis||To detect a difference between treatment arms of 3.06 kg in mean weight change from baseline to endpoint, 150 patients must be enrolled in stepped intervention arm and 50 in control arm. Assuming a standard deviation of 6.87 kg, there is 80% power to detect a difference between treatment arms on a 1-sided 2-sample t-test at the 5% significance level. Primary analysis was the comparison of mean weight change for 'olanzapine only' versus pooled 'olanzapine \& adjunctive treatment' arm at Week 22.||||0.065
72504869|NCT00401973|144540836|SUPERIORITY_OR_OTHER|||||||0.113||95.0|||||Mixed Models Analysis|Repeated Measures Analysis||Hypothesis=weight gain associated with olanzapine can be prevented or mitigated with an adjunctive pharmacological algorithm.||||0.113
72504870|NCT00401973|144540836|SUPERIORITY_OR_OTHER|||||||0.036||95.0|||||Mixed Models Analysis|Repeated Measures Analysis||||||0.036
72504871|NCT00401973|144540837|SUPERIORITY_OR_OTHER|||||||0.498||95.0||||P-value for Change from Baseline for Olanzapine versus pooled olanzapine+amantadine and olanzapine+metformin.|ANCOVA|||||||0.498
72504872|NCT00401973|144540837|SUPERIORITY_OR_OTHER|||||||0.637||95.0||||P-value for Change from Baseline.|ANCOVA|||||||0.637
72504873|NCT00401973|144540837|SUPERIORITY_OR_OTHER|||||||0.125||95.0||||P-value for Change from Baseline.|ANCOVA|||||||0.125
72504874|NCT00401973|144540838|SUPERIORITY_OR_OTHER|||||||0.173||95.0||||P-value for Change from Baseline.|ANCOVA|||||||0.173
72504875|NCT00401973|144540838|SUPERIORITY_OR_OTHER|||||||0.016||95.0||||P-value for Change from Baseline.|ANCOVA|||||||0.016
72504876|NCT00401973|144540838|SUPERIORITY_OR_OTHER|||||||0.029||95.0||||P-value for Change from Baseline for Olanzapine versus pooled olanzapine+amantadine and olanzapine+metformin.|ANCOVA|||||||0.029
72504877|NCT00401973|144540839|SUPERIORITY_OR_OTHER|||||||0.017||95.0||||P-value for Change from Baseline for Olanzapine versus pooled olanzapine+amantadine and olanzapine+metformin.|ANCOVA|||||||0.017
72379249|NCT03569293|144266830|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 15 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|38.7|||<|0.001|TWO_SIDED|95.0|30.9|46.5|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||46.5|30.9|<0.001
72379250|NCT03569293|144266831|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 30 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|52.9|||<|0.001|TWO_SIDED|95.0|45.4|60.3|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||60.3|45.4|<0.001
72379251|NCT03569293|144266831|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 15 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|38.3|||<|0.001|TWO_SIDED|95.0|30.4|46.2|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||46.2|30.4|<0.001
72379252|NCT03569293|144266832|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 30 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|52.5|||<|0.001|TWO_SIDED|95.0|44.7|60.4|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||60.4|44.7|<0.001
72379253|NCT03569293|144266832|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 15 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|42.7|||<|0.001|TWO_SIDED|95.0|34.4|50.9|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||50.9|34.4|<0.001
72379254|NCT03569293|144266833|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 30 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|53.1|||<|0.001|TWO_SIDED|95.0|44.9|61.3|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||61.3|44.9|<0.001
72379255|NCT03569293|144266833|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 15 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|44.7|||<|0.001|TWO_SIDED|95.0|36.2|53.2|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||53.2|36.2|<0.001
72379256|NCT03569293|144266834|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 30 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|25.3|||<|0.001|TWO_SIDED|95.0|20.0|30.6|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||30.6|20.0|<0.001
72379257|NCT03569293|144266834|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 15 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|15.0|||<|0.001|TWO_SIDED|95.0|10.4|19.6|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||19.6|10.4|<0.001
72504878|NCT00401973|144540839|SUPERIORITY_OR_OTHER|||||||0.015||95.0||||P-value for Change from Baseline.|ANCOVA|||||||0.015
72504879|NCT00401973|144540839|SUPERIORITY_OR_OTHER|||||||0.071||95.0||||P-value for Change from Baseline.|ANCOVA|||||||0.071
72504880|NCT00401973|144540840|SUPERIORITY_OR_OTHER|||||||0.152||95.0||||P-value for Change from Baseline for Olanzapine versus pooled olanzapine+amantadine and olanzapine+metformin.|ANCOVA|||||||0.152
72504881|NCT00401973|144540840|SUPERIORITY_OR_OTHER|||||||0.35||95.0||||P-value for Change from Baseline.|ANCOVA|||||||0.350
72504882|NCT00401973|144540840|SUPERIORITY_OR_OTHER|||||||0.123||95.0||||P-value for Change from Baseline.|ANCOVA|||||||0.123
72504883|NCT00401973|144540841|SUPERIORITY_OR_OTHER|||||||0.499||95.0||||P-value for Change from Baseline for Olanzapine versus pooled olanzapine+amantadine and olanzapine+metformin.|ANCOVA|||||||0.499
72504884|NCT00401973|144540841|SUPERIORITY_OR_OTHER|||||||0.833||95.0||||P-value for Change from Baseline.|ANCOVA|||||||0.833
72504885|NCT00401973|144540841|SUPERIORITY_OR_OTHER|||||||0.339||95.0||||P-value for Change from Baseline.|ANCOVA|||||||0.339
72504886|NCT00401973|144540842|SUPERIORITY_OR_OTHER|||||||0.278||95.0||||P-value for Change from Baseline for Olanzapine versus pooled olanzapine+amantadine and olanzapine+metformin.|ANCOVA|||||||0.278
72379258|NCT03569293|144266835|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 30 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer. This endpoint was a multiplicity-controlled key secondary endpoint for European Union (EU)/European Medicines Agency (EMA) regulatory purposes only.|Least Squares (LS) Mean Difference|-45.98|STANDARD_ERROR_OF_MEAN|6.549|<|0.001|TWO_SIDED|95.0|-58.82|-33.15|||Mixed Effect Model Repeated Measurement|Mixed-effect model repeat measurement with Baseline, treatment, visit, treatment by visit interaction, Baseline vIGA-AD category and age in the model.|Difference = Upadacitinib - Placebo|||-33.15|-58.82|<0.001
72379259|NCT03569293|144266835|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 15 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer. This endpoint was a multiplicity-controlled key secondary endpoint for EU/EMA regulatory purposes only.|LS Mean Difference|-36.74|||<|0.001|TWO_SIDED|95.0|-49.66|-23.81|||Mixed Effect Model Repeated Measurement|Mixed-effect model repeat measurement with Baseline, treatment, visit, treatment by visit interaction, Baseline vIGA-AD category and age in the model.|Difference = Upadacitinib - Placebo|||-23.81|-49.66|<0.001
72379260|NCT03569293|144266836|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 30 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer. This endpoint was a multiplicity-controlled key secondary endpoint for EU/EMA regulatory purposes only.|LS Mean Difference|-47.03|STANDARD_ERROR_OF_MEAN|2.716|<|0.001|TWO_SIDED|95.0|-52.37|-41.7|||Mixed Effect Model Repeated Measurement|Mixed-effect model repeat measurement with Baseline, treatment, visit, treatment by visit interaction, Baseline vIGA-AD category and age in the model.|Difference = Upadacitinib - Placebo|||-41.70|-52.37|<0.001
72379261|NCT03569293|144266836|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 15 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer. This endpoint was a multiplicity-controlled key secondary endpoint for EU/EMA regulatory purposes only.|LS Mean Difference|-39.53|STANDARD_ERROR_OF_MEAN|2.738|<|0.001|TWO_SIDED|95.0|-44.91|-34.15|||Mixed Effect Model Repeated Measurement|Mixed-effect model repeat measurement with Baseline, treatment, visit, treatment by visit interaction, Baseline vIGA-AD category and age in the model.|Difference = Upadacitinib - Placebo|||-34.15|-44.91|<0.001
72379262|NCT03569293|144266837|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 30 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer. This endpoint was a multiplicity-controlled key secondary endpoint for EU/EMA regulatory purposes only.|Adjusted Response Rate Difference|58.6|||<|0.001|TWO_SIDED|95.0|51.9|65.3|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||65.3|51.9|<0.001
72379263|NCT03569293|144266837|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 15 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer. This endpoint was a multiplicity-controlled key secondary endpoint for EU/EMA regulatory purposes only.|Adjusted Response Rate Difference|52.3|||<|0.001|TWO_SIDED|95.0|45.2|59.4|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||59.4|45.2|<0.001
72379264|NCT03569293|144266838|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 30 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer. This endpoint was a multiplicity-controlled key secondary endpoint for EU/EMA regulatory purposes only.|Adjusted Response Rate Difference|53.2|||<|0.001|TWO_SIDED|95.0|45.9|60.5|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||60.5|45.9|<0.001
72433620|NCT00991276|144380375|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.69|STANDARD_ERROR_OF_MEAN|0.24||0.0056|TWO_SIDED|95.0|-1.17|-0.21||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||-0.21|-1.17|0.0056
72504887|NCT00401973|144540842|SUPERIORITY_OR_OTHER|||||||0.976||95.0||||P-value for Change from Baseline.|ANCOVA|||||||0.976
72504888|NCT00401973|144540842|SUPERIORITY_OR_OTHER|||||||0.049||95.0||||P-value for Change from Baseline.|ANCOVA|||||||0.049
72504889|NCT00401973|144540843|SUPERIORITY_OR_OTHER|||||||0.122||95.0||||P-value for Change from Baseline for Olanzapine versus pooled olanzapine+amantadine and olanzapine+metformin.|ANCOVA|||||||0.122
72504890|NCT00401973|144540843|SUPERIORITY_OR_OTHER|||||||0.225||95.0||||P-value for Change from Baseline.|ANCOVA|||||||0.225
72504891|NCT00401973|144540843|SUPERIORITY_OR_OTHER|||||||0.124||95.0||||P-value for Change from Baseline.|ANCOVA|||||||0.124
72504892|NCT00401973|144540844|SUPERIORITY_OR_OTHER|||||||0.02||95.0||||P-value for Change from Baseline for Olanzapine versus pooled olanzapine+amantadine and olanzapine+metformin.|ANCOVA|||||||0.020
72504893|NCT00401973|144540844|SUPERIORITY_OR_OTHER|||||||0.037||95.0||||P-value for Change from Baseline|ANCOVA|||||||0.037
72504894|NCT00401973|144540844|SUPERIORITY_OR_OTHER|||||||0.038||95.0||||P-value for Change from Baseline.|ANCOVA|||||||0.038
72379265|NCT03569293|144266838|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 15 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer. This endpoint was a multiplicity-controlled key secondary endpoint for EU/EMA regulatory purposes only.|Adjusted Response Rate Difference|46.7|||<|0.001|TWO_SIDED|95.0|39.0|54.4|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||54.4|39.0|<0.001
72379266|NCT03569293|144266839|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 30 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer. This endpoint was a multiplicity-controlled key secondary endpoint for EU/EMA regulatory purposes only.|LS Mean Difference|-40.39|STANDARD_ERROR_OF_MEAN|2.732|<|0.001|TWO_SIDED|95.0|-45.75|-35.03|||Mixed Effect Model Repeated Measurement|Mixed-effect model repeat measurement with Baseline, treatment, visit, treatment by visit interaction, Baseline vIGA-AD category and age in the model.|Difference = Upadacitinib - Placebo|||-35.03|-45.75|<0.001
72379267|NCT03569293|144266839|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 15 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer. This endpoint was a multiplicity-controlled key secondary endpoint for EU/EMA regulatory purposes only.|LS Mean Difference|-33.03|STANDARD_ERROR_OF_MEAN|2.758|<|0.001|TWO_SIDED|95.0|-38.44|-27.61|||Mixed Effect Model Repeated Measurement|Mixed-effect model repeat measurement with Baseline, treatment, visit, treatment by visit interaction, Baseline vIGA-AD category and age in the model.|Difference = Upadacitinib - Placebo|||-27.61|-38.44|<0.001
72379268|NCT03569293|144266840|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 30 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer. This endpoint was a multiplicity-controlled key secondary endpoint for EU/EMA regulatory purposes only.|Adjusted Response Rate Difference|34.9|||<|0.001|TWO_SIDED|95.0|24.8|45.1|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||45.1|24.8|<0.001
72379269|NCT03569293|144266840|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 15 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer. This endpoint was a multiplicity-controlled key secondary endpoint for EU/EMA regulatory purposes only.|Adjusted Response Rate Difference|31.5|||<|0.001|TWO_SIDED|95.0|21.4|41.6|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||41.6|21.4|<0.001
72379270|NCT03569293|144266841|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 30 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer. This endpoint was a multiplicity-controlled key secondary endpoint for EU/EMA regulatory purposes only.|Adjusted Response Rate Difference|37.3|||<|0.001|TWO_SIDED|95.0|30.8|43.8|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||43.8|30.8|<0.001
72379271|NCT03569293|144266841|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 15 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer. This endpoint was a multiplicity-controlled key secondary endpoint for EU/EMA regulatory purposes only.|Adjusted Response Rate Difference|25.9|||<|0.001|TWO_SIDED|95.0|19.7|32.1|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||32.1|19.7|<0.001
72379272|NCT03569293|144266842|SUPERIORITY||Adjusted Response Rate Difference|66.6|||<|0.001|TWO_SIDED|95.0|53.8|79.4|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||79.4|53.8|<0.001
72379273|NCT03569293|144266842|SUPERIORITY||Adjusted Response Rate Difference|62.0|||<|0.001|TWO_SIDED|95.0|48.6|75.4|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||75.4|48.6|<0.001
72379274|NCT03569293|144266843|SUPERIORITY||Adjusted Response Rate Difference|57.4|||<|0.001|TWO_SIDED|95.0|44.6|70.2|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||70.2|44.6|<0.001
72504895|NCT00401973|144540845|SUPERIORITY_OR_OTHER|||||||0.474||95.0||||P-value for Change from Baseline for Olanzapine versus pooled olanzapine+amantadine and olanzapine+metformin.|ANCOVA|||||||0.474
72504896|NCT00401973|144540845|SUPERIORITY_OR_OTHER|||||||0.404||95.0||||P-value for Change from Baseline.|ANCOVA|||||||0.404
72504897|NCT00401973|144540845|SUPERIORITY_OR_OTHER|||||||0.652||95.0||||P-value for Change from Baseline|ANCOVA|||||||0.652
72504898|NCT01650779|144540859|SUPERIORITY_OR_OTHER|||||||0.0002|||||||One sample t-test|||Baseline versus Month 2: Analysis was performed using one sample t-test.||||0.0002
72504899|NCT01650779|144540859|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||One sample t-test|||Baseline versus Month 4: Analysis was performed using one sample t-test.||||<0.0001
72504900|NCT01650779|144540859|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||One sample t-test|||Baseline versus Month 6: Analysis was performed using one sample t-test.||||<0.0001
72504901|NCT01650779|144540860|SUPERIORITY_OR_OTHER|||||||0.1178|||||||One sample t-test|||Baseline versus Month 2: Analysis was performed using one sample t-test.||||0.1178
72556325|NCT00862563|144643981|SUPERIORITY_OR_OTHER||Difference between least squares means|-24.1|STANDARD_ERROR_OF_MEAN|7.9||0.003|TWO_SIDED||||||ANOVA|||Comparison of Week 11 means for mean percent drinking days obtained for the placebo and zonisamide groups Means used for the analysis are least squares means from a two-way repeated measures mixed models analysis, with Week (time) as the the within subject factor and treatment as the between group factor. Baseline values were used as covariates.||||0.003
72556326|NCT00862563|144643981|SUPERIORITY_OR_OTHER||Difference between least square means|-16.3|STANDARD_ERROR_OF_MEAN|8.0||0.044|TWO_SIDED|||||p\< 0.05 is considered to be significant.|ANOVA|||Comparison of Week 12 means for mean percent drinking days obtained for the placebo and zonisamide groups Means used for the analysis are least squares means from a two-way repeated measures mixed models analysis, with Week (time) as the the within subject factor and treatment as the between group factor. Baseline values were used as covariates.||||0.044
72379275|NCT03569293|144266843|SUPERIORITY||Adjusted Response Rate Difference|39.1|||<|0.001|TWO_SIDED|95.0|25.6|52.6|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||52.6|25.6|<0.001
72379276|NCT03569293|144266844|SUPERIORITY||Adjusted Response Rate Difference|46.6|||<|0.001|TWO_SIDED|95.0|32.6|60.6|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||60.6|32.6|<0.001
72379277|NCT03569293|144266844|SUPERIORITY||Adjusted Response Rate Difference|38.7|||<|0.001|TWO_SIDED|95.0|24.3|53.1|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||53.1|24.3|<0.001
72379278|NCT03569293|144266845|SUPERIORITY||Adjusted Response Rate Difference|63.9|||<|0.001|TWO_SIDED|95.0|51.8|75.9|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||75.9|51.8|<0.001
72379279|NCT03569293|144266845|SUPERIORITY||Adjusted Response Rate Difference|43.8|||<|0.001|TWO_SIDED|95.0|30.9|56.7|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||56.7|30.9|<0.001
72379280|NCT03569293|144266846|SUPERIORITY||Adjusted Response Rate Difference|54.7|||<|0.001|TWO_SIDED|95.0|41.7|67.8|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||67.8|41.7|<0.001
72379281|NCT03569293|144266846|SUPERIORITY||Adjusted Response Rate Difference|45.2|||<|0.001|TWO_SIDED|95.0|32.0|58.3|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||58.3|32.0|<0.001
72379282|NCT03569293|144266847|SUPERIORITY||Adjusted Response Rate Difference|47.1|||<|0.001|TWO_SIDED|95.0|34.0|60.2|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||60.2|34.0|<0.001
72379283|NCT03569293|144266847|SUPERIORITY||Adjusted Response Rate Difference|35.9|||<|0.001|TWO_SIDED|95.0|23.2|48.6|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||48.6|23.2|<0.001
72379284|NCT03569293|144266848|SUPERIORITY||Adjusted Response Rate Difference|21.0|||<|0.001|TWO_SIDED|95.0|11.0|31.1|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||31.1|11.0|<0.001
72504902|NCT01650779|144540860|SUPERIORITY_OR_OTHER|||||||0.1176|||||||One sample t-test|||Baseline versus Month 4: Analysis was performed using one sample t-test.||||0.1176
72618526|NCT01026038|144768103|SUPERIORITY_OR_OTHER||GMC ratio|0.77|||||TWO_SIDED|95.0|0.53|1.13||||||Serotype 6A: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.13|0.53|
72379285|NCT03569293|144266848|SUPERIORITY||Adjusted Response Rate Difference|9.4||||0.008|TWO_SIDED|95.0|2.5|16.4|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||16.4|2.5|0.008
72379286|NCT03569293|144266849|SUPERIORITY||Adjusted Response Rate Difference|11.0||||0.015|TWO_SIDED|95.0|2.1|19.9|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||19.9|2.1|0.015
72379287|NCT03569293|144266849|SUPERIORITY||Adjusted Response Rate Difference|6.5||||0.086|TWO_SIDED|95.0|-0.9|13.9|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||13.9|-0.9|0.086
72379288|NCT03569293|144266850|SUPERIORITY||Adjusted Response Rate Difference|10.8||||0.045|TWO_SIDED|95.0|0.2|21.4|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||21.4|0.2|0.045
72379289|NCT03569293|144266850|SUPERIORITY||Adjusted Response Rate Difference|11.0||||0.04|TWO_SIDED|95.0|0.5|21.5|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||21.5|0.5|0.040
72379290|NCT03569293|144266851|SUPERIORITY||Adjusted Response Rate Difference|-22.1|||<|0.001|TWO_SIDED|95.0|-32.6|-11.5|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||-11.5|-32.6|<0.001
72379291|NCT03569293|144266851|SUPERIORITY||Adjusted Response Rate Difference|-22.1|||<|0.001|TWO_SIDED|95.0|-32.7|-11.5|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||-11.5|-32.7|<0.001
72504903|NCT01650779|144540860|SUPERIORITY_OR_OTHER|||||||0.0322|||||||One sample t-test|||Baseline versus Month 6: Analysis was performed using one sample t-test.||||0.0322
72504904|NCT01650779|144540861|SUPERIORITY_OR_OTHER|||||||0.5811|||||||One sample test of median (sign test)|||Baseline versus Month 2: Analysis was performed using one sample test of median (sign test). The percent change and absolute change from baseline in urine GL-3 levels were not normally distributed and thus medians were evaluated.||||0.5811
72504905|NCT01650779|144540861|SUPERIORITY_OR_OTHER|||||||0.7744|||||||One sample test of median (sign test)|||Baseline versus Month 4: Analysis was performed using one sample test of median (sign test). The percent change and absolute change from baseline in urine GL-3 levels were not normally distributed and thus medians were evaluated.||||0.7744
72556327|NCT00862563|144643981|SUPERIORITY_OR_OTHER||Difference between least squares means|-38.1|STANDARD_ERROR_OF_MEAN|9.0|<|0.0001|TWO_SIDED|||||p\< 0.05 is considered to be significant|ANOVA|||Comparison of Week 10 means for mean percent drinking days obtained for the placebo and topiramate. Means used for the analysis are least squares means from a two-way repeated measures mixed models analysis, with Week (time) as the the within subject factor and treatment as the between group factors. Baseline values were used as covariates.||||<0.0001
72379292|NCT03569293|144266852|SUPERIORITY||Adjusted Response Rate Difference|53.6|||<|0.001|TWO_SIDED|95.0|37.7|69.4|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||69.4|37.7|<0.001
72379293|NCT03569293|144266852|SUPERIORITY||Adjusted Response Rate Difference|34.8|||<|0.001|TWO_SIDED|95.0|18.1|51.4|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||51.4|18.1|<0.001
72379294|NCT03569293|144266853|SUPERIORITY||Adjusted Response Rate Difference|56.6|||<|0.001|TWO_SIDED|95.0|42.0|71.1|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||71.1|42.0|<0.001
72379295|NCT03569293|144266853|SUPERIORITY||Adjusted Response Rate Difference|32.5|||<|0.001|TWO_SIDED|95.0|16.9|48.1|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||48.1|16.9|<0.001
72379296|NCT03569293|144266854|SUPERIORITY||Adjusted Response Rate Difference|50.9|||<|0.001|TWO_SIDED|95.0|35.1|66.7|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||66.7|35.1|<0.001
72379297|NCT03569293|144266854|SUPERIORITY||Adjusted Response Rate Difference|35.7|||<|0.001|TWO_SIDED|95.0|18.8|52.6|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||52.6|18.8|<0.001
72379298|NCT03569293|144266855|SUPERIORITY||Adjusted Response Rate Difference|54.4|||<|0.001|TWO_SIDED|95.0|37.4|71.3|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||71.3|37.4|<0.001
72379299|NCT03569293|144266855|SUPERIORITY||Adjusted Response Rate Difference|38.1|||<|0.001|TWO_SIDED|95.0|19.8|56.4|||Chi-squared, Corrected|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||56.4|19.8|<0.001
72379300|NCT03569293|144266856|SUPERIORITY||Adjusted Response Rate Difference|51.2|||<|0.001|TWO_SIDED|95.0|33.3|69.1|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||69.1|33.3|<0.001
72379301|NCT03569293|144266856|SUPERIORITY||Adjusted Response Rate Difference|28.1||||0.006|TWO_SIDED|95.0|8.0|48.2|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||48.2|8.0|0.006
72379302|NCT03569293|144266857|SUPERIORITY||Adjusted Response Rate Difference|31.2|||<|0.001|TWO_SIDED|95.0|19.9|42.5|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||42.5|19.9|<0.001
72618527|NCT01026038|144768103|SUPERIORITY_OR_OTHER||GMC ratio|1.63|||||TWO_SIDED|95.0|1.28|2.08||||||Serotype 7F: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||2.08|1.28|
72379303|NCT03569293|144266857|SUPERIORITY||Adjusted Response Rate Difference|15.8||||0.001|TWO_SIDED|95.0|6.9|24.6|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||24.6|6.9|0.001
72379304|NCT03569293|144266858|SUPERIORITY||LS Mean Difference|-42.42|||<|0.001|TWO_SIDED|95.0|-56.16|-28.68|||Mixed Effect Model Repeated Measurement|Mixed-effect model repeat measurement with Baseline, treatment, visit, treatment by visit interaction, and Baseline vIGA-AD category in the model.|Difference = Upadacitinib - Placebo|||-28.68|-56.16|<0.001
72379305|NCT03569293|144266858|SUPERIORITY||LS Mean Difference|-33.88|||<|0.001|TWO_SIDED|95.0|-47.76|-19.99|||Mixed Effect Model Repeated Measurement|Mixed-effect model repeat measurement with Baseline, treatment, visit, treatment by visit interaction, and Baseline vIGA-AD category in the model.|Difference = Upadacitinib - Placebo|||-19.99|-47.76|<0.001
72379306|NCT03569293|144266859|SUPERIORITY||LS Mean Difference|-41.84|||<|0.001|TWO_SIDED|95.0|-52.09|-31.58|||Mixed Effect Model Repeated Measurement|Mixed-Effect Model Repeat Measurement with Baseline, treatment, visit, treatment by visit interaction, and Baseline vIGA-AD category in the model.|Difference = Upadacitinib - Placebo|||-31.58|-52.09|<0.001
72379307|NCT03569293|144266859|SUPERIORITY||LS Mean Difference|-37.84|||<|0.001|TWO_SIDED|95.0|-48.17|-27.52|||Mixed Effect Model Repeated Measurement|Mixed-Effect Model Repeat Measurement with Baseline, treatment, visit, treatment by visit interaction, and Baseline vIGA-AD category in the model.|Difference = Upadacitinib - Placebo|||-27.52|-48.17|<0.001
72379308|NCT03569293|144266860|SUPERIORITY||Adjusted Response Rate Difference|54.8|||<|0.001|TWO_SIDED|95.0|40.3|69.4|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||69.4|40.3|<0.001
72379309|NCT03569293|144266860|SUPERIORITY||Adjusted Response Rate Difference|50.0|||<|0.001|TWO_SIDED|95.0|34.8|65.3|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||65.3|34.8|<0.001
72379310|NCT03569293|144266861|SUPERIORITY||Adjusted Response Rate Difference|45.1|||<|0.001|TWO_SIDED|95.0|21.0|69.2|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||69.2|21.0|<0.001
72379311|NCT03569293|144266861|SUPERIORITY||Adjusted Response Rate Difference|49.6|||<|0.001|TWO_SIDED|95.0|26.7|72.5|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||72.5|26.7|<0.001
72379312|NCT03569293|144266862|SUPERIORITY||LS Mean Difference|-38.92|||<|0.001|TWO_SIDED|95.0|-49.54|-28.31|||Mixed Effect Model Repeated Measurement|Mixed-effect model repeat measurement with Baseline, treatment, visit, treatment by visit interaction, and Baseline vIGA-AD category|Difference = Upadacitinib - Placebo|||-28.31|-49.54|<0.001
72379313|NCT03569293|144266862|SUPERIORITY||LS Mean Difference|-32.7|||<|0.001|TWO_SIDED|95.0|-43.44|-21.96|||Mixed Effect Model Repeated Measurement|Mixed-effect model repeat measurement with Baseline, treatment, visit, treatment by visit interaction, and Baseline vIGA-AD category|Difference = Upadacitinib - Placebo|||-21.96|-43.44|<0.001
72379314|NCT03569293|144266863|SUPERIORITY||Adjusted Response Rate Difference|51.7|||<|0.001|TWO_SIDED|95.0|31.7|71.8|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||71.8|31.7|<0.001
72379315|NCT03569293|144266863|SUPERIORITY||Adjusted Response Rate Difference|44.7|||<|0.001|TWO_SIDED|95.0|26.7|62.8|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||62.8|26.7|<0.001
72379316|NCT03569293|144266864|SUPERIORITY||Adjusted Response Rate Difference|25.1||||0.006|TWO_SIDED|95.0|7.3|43.0|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||43.0|7.3|0.006
72379317|NCT03569293|144266864|SUPERIORITY||Adjusted Response Rate Difference|15.8||||0.093|TWO_SIDED|95.0|-2.6|34.2|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||34.2|-2.6|0.093
72379318|NCT05803603|144266888|SUPERIORITY||Odds Ratio (OR)|2.0||||0.125|TWO_SIDED|95.0|0.37|10.92|||McNemar|||We recruited 8 homeless individuals and followed them for 12 months. 4 individuals (50%) were housed at 6 months and 3 (37.5) were housed at 12 months.|See results above|10.92|.37|.125
72379319|NCT05128929|144266889|SUPERIORITY||Mean Difference (Final Values)|0.614||||0.541|TWO_SIDED|95.0|-1.47|2.79|||Mixed Models Analysis|Analysis was adjusted for the randomization stratum of PAH Group.||"Null: There is no significant difference in the mean primary endpoint (PVR) at 24 weeks between the treatment (H01) and placebo group.~The following analysis utilizes PVR determined by TD."||2.79|-1.47|0.541
72379320|NCT05128929|144266891|SUPERIORITY||Mean Difference (Final Values)|1.47||||0.599|TWO_SIDED|95.0|-4.34|7.27|||Mixed Models Analysis|Analysis was adjusted for the randomization stratum of PAH Group.||Null: There is no significant difference in the mean secondary endpoint (mPAP) at 24 weeks between the treatment (H01) and placebo group.||7.27|-4.34|0.599
72379321|NCT05128929|144266892|SUPERIORITY||Mean Difference (Final Values)|47.26||||0.166|TWO_SIDED|95.0|-21.43|115.95|||Mixed Models Analysis|Analysis was adjusted for the randomization stratum of PAH Group.||Null: There is no significant difference in the mean secondary endpoint (6MWT distance) at 24 weeks between the treatment (H01) and placebo group.||115.95|-21.43|0.166
72379322|NCT05128929|144266893|SUPERIORITY||Mean Difference (Final Values)|-0.12||||0.975|TWO_SIDED|95.0|-8.22|7.98|||Mixed Models Analysis|Analysis was adjusted for the randomization stratum of PAH Group.||Null: There is no significant difference in the mean secondary endpoint (emPHasis-10 score) at 24 weeks between the treatment (H01) and placebo group.||7.98|-8.22|0.975
72379323|NCT05128929|144266894|SUPERIORITY||Mean Difference (Final Values)|-9.0||||0.086|TWO_SIDED|95.0|-19.4|1.4|||Mixed Models Analysis|Analysis was adjusted for the randomization stratum of PAH Group.||Null: There is no significant difference in the mean secondary endpoint (SGRQ Score) at 24 weeks between the treatment (H01) and placebo group.||1.4|-19.40|0.086
72379324|NCT05128929|144266895|SUPERIORITY||Mean Difference (Final Values)|73.92||||0.215|TWO_SIDED|95.0|-45.61|193.46|||Mixed Models Analysis|Analysis was adjusted for the randomization stratum of PAH Group.||Null: There is no significant difference in the mean secondary endpoint (serum HA) at 24 weeks between the treatment (H01) and placebo group.||193.46|-45.61|0.215
72556328|NCT00862563|144643981|SUPERIORITY_OR_OTHER||Difference between least squares means|-47.6|STANDARD_ERROR_OF_MEAN|9.1|<|0.0001|TWO_SIDED|||||p\<0.05 is considered to be significant.|ANOVA|||Comparison of Week 11 means for mean percent drinking days obtained for the placebo and topiramate. Means used for the analysis are least squares means from a two-way repeated measures mixed models analysis, with Week (time) as the the within subject factor and treatment as the between group factor. Baseline values were used as covariates.||||<0.0001
72556329|NCT00862563|144643981|SUPERIORITY_OR_OTHER||Difference between least squares means|-34.0|STANDARD_ERROR_OF_MEAN|9.2||0.0004|TWO_SIDED|||||p\<0.05 is considered to be significant.|ANOVA|||Week 12.Comparison of Week 12 means for mean percent drinking days obtained for the placebo and topiramate. Means used for the analysis are least squares means from a two-way repeated measures mixed models analysis, with Week (time) as the the within subject factor and treatment as the between group factor. Baseline values were used as covariates.||||0.0004
72379325|NCT05128929|144266896|SUPERIORITY||Mean Difference (Final Values)|231.47||||0.442|TWO_SIDED|95.0|-377.26|840.2|||Mixed Models Analysis|||There is no significant difference in the mean secondary endpoint (NT-proBNP) at 24 weeks between the treatment (H01) and placebo group.||840.20|-377.26|0.442
72379326|NCT02742246|144266906|SUPERIORITY|||||||0.11||||||Group by Time interaction.|Regression, Linear|||||||0.11
72379327|NCT02742246|144266907|SUPERIORITY|||||||0.14||||||Group by time interaction.|Regression, Linear|||||||0.14
72379328|NCT03553836|144266908|SUPERIORITY||Hazard Ratio (HR)|0.61||||0.00046|TWO_SIDED|95.0|0.45|0.82||One-sided p-value based on log-rank test stratified by melanoma T Stage (T3b, T4a, T4b).|Log Rank||Hazard Ratio based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by melanoma T Stage (T3b, T4a, T4b).|||0.82|0.45|0.00046
72379329|NCT03553836|144266911|OTHER|Difference in percentage based on Miettinen \& Nurminen method.|Difference in Percentage|4.1|||||TWO_SIDED|95.0|1.0|7.3||||||||7.3|1.0|
72379330|NCT03553836|144266912|OTHER|Difference in percentage based on Miettinen \& Nurminen method.|Difference in percentage|12.9|||||TWO_SIDED|95.0|9.1|16.9||||||||16.9|9.1|
72379331|NCT02397564|144266919|SUPERIORITY_OR_OTHER|||||||0.019|||||||Wilcoxon (Mann-Whitney)|||||||0.019
72379332|NCT03584373|144266921|NON_INFERIORITY|Non-inferiority margin of 1.3|Mean Difference (Net)|-0.14||||0.7|TWO_SIDED|95.0|-0.89|0.6|||t-test, 2 sided|||||0.60|-0.89|0.70
72379333|NCT03584373|144266922|NON_INFERIORITY|Non-inferiority margin of 1.3|Mean Difference (Net)|-0.23||||0.58|TWO_SIDED|95.0|-1.08|0.61|||t-test, 2 sided|||||0.61|-1.08|0.58
72379334|NCT03584373|144266923|NON_INFERIORITY|Non-inferiority margin of 1.3|Mean Difference (Net)|-1.91||||0.006|TWO_SIDED|95.0|-3.25|-0.56|||t-test, 2 sided|||||-0.56|-3.25|0.006
72379335|NCT03584373|144266924|NON_INFERIORITY|Non-inferiority margin of 1.3|Mean Difference (Net)|-1.16||||0.04|TWO_SIDED|95.0|-2.26|-0.06|||t-test, 2 sided|||||-0.06|-2.26|0.04
72379336|NCT03584373|144266925|NON_INFERIORITY|Non-inferiority margin of 1.3|Mean Difference (Net)|-0.55||||0.33|TWO_SIDED|95.0|-1.67|0.56|||t-test, 2 sided|||||0.56|-1.67|0.33
72379337|NCT03584373|144266926|NON_INFERIORITY|Non-inferiority margin of 1.3|Mean Difference (Net)|0.06||||0.47|TWO_SIDED|95.0|-0.1|0.21|||t-test, 2 sided|||||0.21|-0.10|0.47
72379338|NCT01155479|144266959|SUPERIORITY_OR_OTHER||Difference in Estimated Means|2.6||||0.0033|TWO_SIDED|95.0|0.86|4.3|||constrained longitudinal analysis|||Preladenant 2 mg (Part 1) vs Placebo (Part 1)||4.30|0.86|0.0033
72379339|NCT01155479|144266959|SUPERIORITY_OR_OTHER||Difference in Estimated Means|1.3||||0.1382|TWO_SIDED|95.0|-0.41|2.94|||constrained longitudinal analysis|||Preladenant 5 mg (Part 1) vs Placebo (Part 1)||2.94|-0.41|0.1382
72379340|NCT01155479|144266959|SUPERIORITY_OR_OTHER||Difference in Estimated Means|0.4||||0.6378|TWO_SIDED|95.0|-1.29|2.11|||constrained longitudinal analysis|||Preladenant 10 mg (Part 1) vs Placebo (Part 1)||2.11|-1.29|0.6378
72379341|NCT01155479|144266959|SUPERIORITY_OR_OTHER||Difference in Estimated Means|0.3||||0.6923|TWO_SIDED|95.0|-1.35|2.03|||constrained longitudinal analysis|||Rasagiline (Part 1) vs Placebo (Part 1)||2.03|-1.35|0.6923
72379342|NCT01155479|144266960|SUPERIORITY_OR_OTHER||Difference vs Placebo (%)|-9.7||||0.0785|TWO_SIDED|95.0|-21.0|1.82||p-value is for the estimated Odds Ratio based on a generalized linear mixed model with baseline UPDRS2+3 as a covariate and treatment-by-time interaction as fixed effect and participant as random effect.|generalized linear mixed model|||Preladenant 2 mg (Part 1) vs Placebo (Part 1)||1.82|-21.0|0.0785
72379343|NCT01155479|144266960|SUPERIORITY_OR_OTHER||Difference vs Placebo (%)|-6.3||||0.2735|TWO_SIDED|95.0|-17.6|5.05||p-value is for the estimated Odds Ratio based on a generalized linear mixed model with baseline UPDRS2+3 as a covariate and treatment-by-time interaction as fixed effect and participant as random effect.|generalized linear mixed model|||Preladenant 5 mg (Part 1) vs Placebo (Part 1)||5.05|-17.6|0.2735
72379344|NCT01155479|144266960|SUPERIORITY_OR_OTHER||Difference vs Placebo (%)|-3.7||||0.4823|TWO_SIDED|95.0|-15.2|7.99||p-value is for the estimated Odds Ratio based on a generalized linear mixed model with baseline UPDRS2+3 as a covariate and treatment-by-time interaction as fixed effect and participant as random effect.|generalized linear mixed model|||Preladenant 10 mg (Part 1) vs Placebo (Part 1)||7.99|-15.2|0.4823
72379345|NCT01155479|144266960|SUPERIORITY_OR_OTHER||Difference vs Placebo (%)|-2.3||||0.6827|TWO_SIDED|95.0|-13.9|9.24||p-value is for the estimated Odds Ratio based on a generalized linear mixed model with baseline UPDRS2+3 as a covariate and treatment-by-time interaction as fixed effect and participant as random effect.|generalized linear mixed model|||Rasagiline (Part 1) vs Placebo (Part 1)||9.24|-13.9|0.6827
72504906|NCT01650779|144540861|SUPERIORITY_OR_OTHER|||||||0.3877|||||||One sample test of median (sign test)|||Baseline versus Month 6: Analysis was performed using one sample test of median (sign test). The percent change and absolute change from baseline in urine GL-3 levels were not normally distributed and thus medians were evaluated.||||0.3877
72504907|NCT00283712|144540875|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.0||||1|TWO_SIDED|90.0|-0.22|0.22|||Fisher Exact|||The study goals were to gather evidence of safety and possible efficacy of infliximab for treatment of pemphigus vulgaris (PV). The analyses focused on estimation rather than hypothesis testing; therefore, there was not sufficient power to detect plausible treatment differences unless they were very large. The sample size reflects a balance between the desire to meet study goals and to expose as few participants as possible until the safety of infliximab for treatment of PV has been clarified.||0.22|-0.22|1.00
72379346|NCT01155479|144266961|SUPERIORITY_OR_OTHER||Difference in Estimated Means|0.7||||0.0235|TWO_SIDED|95.0|0.09|1.27|||constrained longitudinal analysis|||Preladenant 2 mg (Part 1) vs Placebo (Part 1)||1.27|0.09|0.0235
72379347|NCT01155479|144266961|SUPERIORITY_OR_OTHER||Difference in Estimated Means|0.5||||0.1093|TWO_SIDED|95.0|-0.11|1.04|||constrained longitudinal analysis|||Preladenant 5 mg (Part 1) vs Placebo (Part 1)||1.04|-0.11|0.1093
72379348|NCT01155479|144266961|SUPERIORITY_OR_OTHER||Difference in Estimated Means|0.2||||0.5756|TWO_SIDED|95.0|-0.42|0.75|||constrained longitudinal analysis|||Preladenant 10 mg (Part 1) vs Placebo (Part 1)||0.75|-0.42|0.5756
72379349|NCT01155479|144266961|SUPERIORITY_OR_OTHER||Difference in Estimated Means|0.1||||0.6657|TWO_SIDED|95.0|-0.45|0.7|||constrained longitudinal analysis|||Rasagiline (Part 1) vs Placebo (Part 1)||0.70|-0.45|0.6657
72379350|NCT00998764|144266967|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.74||||0.324|TWO_SIDED|95.0|-0.74|2.23|||Mixed Models Analysis|||Change from baseline in Alzheimer's Disease Assesment Scale-Cognitive Subscale (ADAS-Cog) at week 13||2.23|-0.74|0.324
72379351|NCT00998764|144266967|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.29||||0.723|TWO_SIDED|95.0|-1.33|1.92|||Mixed Models Analysis|||Change from baseline in Alzheimer's Disease Assesment Scale-Cognitive Subscale (ADAS-Cog) at week 26||1.92|-1.33|0.723
72379352|NCT00998764|144266967|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.04||||0.966|TWO_SIDED|95.0|-1.81|1.89|||Mixed Models Analysis|||Change from baseline in Alzheimer's Disease Assesment Scale-Cognitive Subscale (ADAS-Cog) at week 39||1.89|-1.81|0.966
72379353|NCT00998764|144266967|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.996|TWO_SIDED|95.0|-1.93|1.92|||Mixed Models Analysis|||Change from baseline in Alzheimer's Disease Assesment Scale-Cognitive Subscale (ADAS-Cog) at week 52||1.92|-1.93|0.996
72379354|NCT00998764|144266967|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.21||||0.336|TWO_SIDED|95.0|-3.67|1.26|||Mixed Models Analysis|||Change from baseline in Alzheimer's Disease Assesment Scale-Cognitive Subscale (ADAS-Cog) at week 78||1.26|-3.67|0.336
72379355|NCT00998764|144266968|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.16||||0.737|TWO_SIDED|95.0|-1.11|0.79|||Mixed Models Analysis|||Change from extension study baseline in ADAS-Cog at week 13||0.79|-1.11|0.737
72504908|NCT00283712|144540875|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.0||||1|TWO_SIDED|90.0|0.02|42.67|||Fisher Exact|||||42.67|0.02|1.00
72504909|NCT00283712|144540876|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.1|||||TWO_SIDED|90.0|-0.26|0.06||||||||0.06|-0.26|
72504910|NCT00283712|144540877|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.02||||1|TWO_SIDED|90.0|-0.31|0.36||All secondary analyses are considered supplemental supportive analyses|Fisher Exact|||The primary endpoint analysis was replicated using the per-protocol population.||0.36|-0.31|1.00
72504911|NCT00283712|144540877|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.83||||1|TWO_SIDED|90.0|0.02|38.35||All secondary analyses are considered supplemental supportive analyses|Fisher Exact|||The primary endpoint analysis was replicated using the per-protocol population.||38.35|0.02|1.00
72379356|NCT00998764|144266968|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.68||||0.213|TWO_SIDED|95.0|-1.76|0.4|||Mixed Models Analysis|||Change from extension study baseline in ADAS-Cog at week 26||0.40|-1.76|0.213
72379357|NCT00998764|144266968|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9||||0.168|TWO_SIDED|95.0|-2.19|0.38|||Mixed Models Analysis|||Change from extension study baseline in ADAS-Cog at week 39||0.38|-2.19|0.168
72379358|NCT00998764|144266968|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.91||||0.197|TWO_SIDED|95.0|-2.3|0.48|||Mixed Models Analysis|||Change from extension study baseline in ADAS-Cog at week 52||0.48|-2.30|0.197
72379359|NCT00998764|144266968|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.13||||0.044|TWO_SIDED|95.0|-4.21|0.06|||Mixed Models Analysis|||Change from extension study baseline in ADAS-Cog at week 78||0.06|-4.21|0.044
72379360|NCT00998764|144266969|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.99||||0.077|TWO_SIDED|95.0|-6.3|0.33|||Mixed Models Analysis|||Change from base study baseline in DAD score at Week 13||0.33|-6.30|0.077
72379361|NCT00998764|144266969|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.67||||0.117|TWO_SIDED|95.0|-6.02|0.67|||Mixed Models Analysis|||Change from base study baseline in DAD score at Week 26||0.67|-6.02|0.117
72379362|NCT00998764|144266969|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.6||||0.063|TWO_SIDED|95.0|-7.38|0.19|||Mixed Models Analysis|||Change from base study baseline in DAD score at Week 39||0.19|-7.38|0.063
72379363|NCT00998764|144266969|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.75||||0.412|TWO_SIDED|95.0|-5.95|2.44|||Mixed Models Analysis|||Change from base study baseline in DAD score at Week 52||2.44|-5.95|0.412
72379364|NCT00998764|144266969|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.78||||0.321|TWO_SIDED|95.0|-8.28|2.73|||Mixed Models Analysis|||Change from base study baseline in DAD score at Week 78||2.73|-8.28|0.321
72379365|NCT00998764|144266970|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.08||||0.329|TWO_SIDED|95.0|-3.24|1.09|||Mixed Models Analysis|||Change from extension study baseline in DAD score at Week 13||1.09|-3.24|0.329
72379366|NCT00998764|144266970|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7||||0.601|TWO_SIDED|95.0|-3.31|1.92|||Mixed Models Analysis|||Change from extension study baseline in DAD score at Week 26||1.92|-3.31|0.601
72379367|NCT00998764|144266970|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.55||||0.328|TWO_SIDED|95.0|-4.67|1.56|||Mixed Models Analysis|||Change from extension study baseline in DAD score at Week 39||1.56|-4.67|0.328
72379368|NCT00998764|144266970|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.71||||0.68|TWO_SIDED|95.0|-2.7|4.13|||Mixed Models Analysis|||Change from extension study baseline in DAD score at Week 52||4.13|-2.70|0.680
72379369|NCT00998764|144266970|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.14||||0.954|TWO_SIDED|95.0|-5.05|4.77|||Mixed Models Analysis|||Change from extension study baseline in DAD score at Week 78||4.77|-5.05|0.954
72379370|NCT00998764|144266971|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.11||||0.931|TWO_SIDED|95.0|-2.4|2.62|||Mixed Models Analysis|||Change from base study baseline in NPI score at week 26.||2.62|-2.40|0.931
72504912|NCT00283712|144540878|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.2||||0.65|TWO_SIDED|90.0|-0.15|0.55|||Fisher Exact|||||0.55|-0.15|0.65
72379371|NCT00998764|144266971|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8||||0.524|TWO_SIDED|95.0|-3.26|1.67|||Mixed Models Analysis|||Change from base study baseline in NPI score at week 52.||1.67|-3.26|0.524
72379372|NCT00998764|144266971|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.03||||0.353|TWO_SIDED|95.0|-6.32|2.27|||Mixed Models Analysis|||Change from base study baseline in NPI score at week 78.||2.27|-6.32|0.353
72379373|NCT00998764|144266972|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.71||||0.531|TWO_SIDED|95.0|-2.92|1.51|||Mixed Models Analysis|||Change from extension study baseline in NPI score at week 26.||1.51|-2.92|0.531
72379374|NCT00998764|144266972|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.84||||0.137|TWO_SIDED|95.0|-4.28|0.59|||Mixed Models Analysis|||Change from extension study baseline in NPI score at week 52.||0.59|-4.28|0.137
72379375|NCT00998764|144266972|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.32||||0.128|TWO_SIDED|95.0|-7.6|0.96|||Mixed Models Analysis|||Change from extension study baseline in NPI score at week 78.||0.96|-7.60|0.128
72379376|NCT00998764|144266973|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.07||||0.811|TWO_SIDED|95.0|-0.49|0.63|||Mixed Models Analysis|||Change from base study baseline in MMSE score at Week 6.||0.63|-0.49|0.811
72379377|NCT00998764|144266973|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.12||||0.681|TWO_SIDED|95.0|-0.45|0.69|||Mixed Models Analysis|||Change from base study baseline in MMSE score at Week 19.||0.69|-0.45|0.681
72379378|NCT00998764|144266973|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||0.742|TWO_SIDED|95.0|-0.51|0.72|||Mixed Models Analysis|||Change from extension study baseline in MMSE score at Week 32.||0.72|-0.51|0.742
72379379|NCT00998764|144266973|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.18||||0.598|TWO_SIDED|95.0|-0.48|0.83|||Mixed Models Analysis|||Change from extension study baseline in MMSE score at Week 45.||0.83|-0.48|0.598
72379380|NCT00998764|144266973|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.04||||0.922|TWO_SIDED|95.0|-0.85|0.77|||Mixed Models Analysis|||Change from extension study baseline in MMSE score at Week 78.||0.77|-0.85|0.922
72379381|NCT00998764|144266974|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.41||||0.099|TWO_SIDED|95.0|-0.08|0.9|||Mixed Models Analysis|||Change from extension study baseline in MMSE score at Week 6.||0.90|-0.08|0.099
72379382|NCT00998764|144266974|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.47||||0.089|TWO_SIDED|95.0|-0.07|1.01|||Mixed Models Analysis|||Change from extension study baseline in MMSE score at Week 19.||1.01|-0.07|0.089
72379383|NCT00998764|144266974|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.45||||0.152|TWO_SIDED|95.0|-0.17|1.08|||Mixed Models Analysis|||Change from extension study baseline in MMSE score at Week 32.||1.08|-0.17|0.152
72379384|NCT00998764|144266974|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.52||||0.16|TWO_SIDED|95.0|-0.21|1.25|||Mixed Models Analysis|||Change from extension study baseline in MMSE score at Week 45.||1.25|-0.21|0.160
72379385|NCT00998764|144266974|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.26||||0.603|TWO_SIDED|95.0|-0.73|1.26|||Mixed Models Analysis|||Change from extension study baseline in MMSE score at Week 78.||1.26|-0.73|0.603
72504913|NCT00283712|144540878|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.43||||0.65|TWO_SIDED|90.0|0.06|2.79|||Fisher Exact|||||2.79|0.06|0.650
72504914|NCT00283712|144540888|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||1|TWO_SIDED|90.0|-0.3|0.3|||Fisher Exact|||||0.3|-0.3|1.00
72379386|NCT04761627|144266975|EQUIVALENCE|The prespecified similarity margin was 0.8 to 1.25.|Geometric Least Squares (LS) Means Ratio|0.9325|||||TWO_SIDED|90.0|0.8874|0.9799|||||Switching group vs Continued-use group.|The ratio of geometric LS means, and 90% confidence intervals (CIs) were estimated using the analysis of covariance (ANCOVA) model adjusted for the actual stratification factors if prior biologic use for psoriasis, baseline body weight group, geographic region, and PK trough concentration at week 28.||0.9799|0.8874|
72379387|NCT04761627|144266976|EQUIVALENCE|The prespecified similarity margin was 0.8 to 1.25.|Geometric LS Means Ratio|0.9483|||||TWO_SIDED|90.0|0.8977|1.0018|||||Switching group vs Continued-use group.|The ratio of geometric LS means, and 90% CIs were estimated using the ANCOVA model adjusted for the actual stratification factors if prior biologic use for psoriasis, baseline body weight group, geographic region, and PK trough concentration at week 28.||1.0018|0.8977|
72379388|NCT04761627|144266978|EQUIVALENCE|The prespecified similarity margin was 0.8 to 1.25.|Geometric LS Means Ratio|0.9617|||||TWO_SIDED|90.0|0.8319|1.1119|||||Ctrough,ss at Week 28: Switching group vs Continued-use group|The ratio of Geometric LS means, and 90% CI for Ctrough,ss at week 28 were estimated based on an ANCOVA model adjusted for the actual stratification factors of prior biologic use for psoriasis, baseline body weight group, and geographic region.||1.1119|0.8319|
72379389|NCT04761627|144266978|EQUIVALENCE|The prespecified similarity margin was 0.8 to 1.25.|Geometric LS Means Ratio|0.9662|||||TWO_SIDED|90.0|0.8879|1.0515|||||Ctrough,ss at Week 40: Switching group vs Continued-use group|The ratio of geometric LS means, and 90% CI for Ctrough,ss at week 40 between the 2 treatment groups were estimated using an ANCOVA model adjusting for stratification factors and PK trough concentration at week 28.||1.0515|0.8879|
72379390|NCT04761627|144266978|EQUIVALENCE|The prespecified similarity margin was 0.8 to 1.25.|Geomtric LS Means Ratio|0.9806|||||TWO_SIDED|90.0|0.8916|1.0785|||||Ctrough,ss at Week 52: Switching group vs Continued-use group|The ratio of geometric LS means, and 90% CI for Ctrough,ss at week 52 between the 2 treatment groups were estimated using an ANCOVA model adjusting for stratification factors and PK trough concentration at week 28.||1.0785|0.8916|
72379391|NCT04761627|144266979|EQUIVALENCE|The prespecified similarity margin was 0.8 to 1.25.|Mean difference|0.07|||||TWO_SIDED|90.0|-2.62|2.77|||||Mean difference in PASI percent improvement from baseline at Week 64: Switching group - Continued-use group|Multiple imputation was applied for the point estimate and CI of the mean difference between the switching and continued-use groups. Missing PASI scores at the week 64 visit were imputed by MI.||2.77|-2.62|
72379392|NCT04761627|144266980|EQUIVALENCE|The prespecified similarity margin was 0.8 to 1.25.|Response difference|0.2|||||TWO_SIDED|90.0|-5.7|6.2|||||Response difference in PASI 75 Response at Week 64: Switching group - Continued-use group|Response difference was estimated by the Mantel-Haenszel estimate, and the 90% CIs were estimated by the stratified Newcombe confidence limits, adjusting for the prior biologic use of psoriasis, baseline body weight group, geographic region. Missing post-baseline binary response data were imputed by NRI.||6.2|-5.7|
72379393|NCT04761627|144266981|EQUIVALENCE|The prespecified similarity margin was 0.8 to 1.25.|Response difference|0.2|||||TWO_SIDED|90.0|-7.4|7.8|||||Response difference in PASI 100 Response at Week 64: Switching group - Continued-use group|Response difference was estimated by the Mantel-Haenszel estimate, and the 90% CIs were estimated by the stratified Newcombe confidence limits, adjusting for the prior biologic use of psoriasis, baseline body weight group, geographic region. Missing post-baseline binary response data were imputed by NRI.||7.8|-7.4|
72379394|NCT04761627|144266983|EQUIVALENCE|The prespecified similarity margin was 0.8 to 1.25.|Risk Difference (RD)|-0.48|||||TWO_SIDED|90.0|-4.17|3.1|||||Switching group - continued-use group|Risk difference for any EOI: risk difference and CIs were estimated by Wald asymptotic confidence limits, or exact confidence limits if n \< 25 for either treatment.||3.10|-4.17|
72379395|NCT01634178|144266999|OTHER|Food was considered to have no effect on the PK of apremilast if the 90% confidence interval (CI) of the geometric least squares (LS) mean ratios for AUC0-t and Cmax were completely contained within the range of 80% to 125%.|Ratio of Geometric Least Squares Means|98.3|||||TWO_SIDED|90.0|90.7|106.6|||||Ratio of the geometric LS means (Fed/Fasted), reported as percentages.|To assess the food effect, an analysis of variance model (ANOVA) with treatment, sequence, and period as fixed effects, and subject nested within sequence as a random effect, was performed on the natural log-transformed Cmax of apremilast.||106.6|90.7|
72379396|NCT01634178|144267001|OTHER||Median Difference|0.75||||0.0077|TWO_SIDED|90.0|0.25|1.25|||Wilcoxon signed-rank test||Median difference (Fed - Fasted) calculated from the Hodges-Lehmann estimate.|Tmax was analyzed by nonparametric methods. The median difference and 90% CI of the median difference were calculated from the Hodges-Lehrmann estimate.||1.25|0.25|0.0077
72379397|NCT01634178|144267002|OTHER|Food was considered to have no effect on the PK of apremilast if the 90% CI of the geometric LS mean ratios for AUC0-t and Cmax were completely contained within the range of 80% to 125%.|Ratio of Geometric LS Means|112.4|||||TWO_SIDED|90.0|109.3|115.6|||||Ratio of the geometric LS means (Fed/Fasted), reported as percentages.|To assess the food effect, an analysis of variance model (ANOVA) with treatment, sequence, and period as fixed effects, and subject nested within sequence as a random effect, was performed on the natural log-transformed AUC0-t of apremilast.||115.6|109.3|
72379398|NCT01634178|144267003|OTHER||Ratio of Geometric Least Squares Means|112.0|||||TWO_SIDED|90.0|108.9|115.1|||||Ratio of the geometric LS means (Fed/Fasted), reported as percentages.|To assess the food effect, an ANOVA with treatment, sequence, and period as fixed effects, and subject nested within sequence as a random effect, was performed on the natural log-transformed AUC0-∞ of apremilast.||115.1|108.9|
72379399|NCT00251004|144267065|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin was set at 10%.|Difference in percentage|2.2||||0.001|TWO_SIDED|95.0|-2.9|7.3||To control for multiple comparisons, the two-sided significance level was set at 0.025.|Z-test|||Everolimus is non-inferior to mycophenolic acid (MPA) if the upper limit of the 95% confidence interval for the difference in combined graft loss, death or loss to follow-up rates is \<10%.||7.3|-2.9|0.001
72379400|NCT00251004|144267065|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin was set at 10%.|Difference in Percentage|0.3|||<|0.001|TWO_SIDED|95.0|-4.6|5.2||To control for multiple comparisons, the two-sided significance level was set at 0.025.|Z-test|||Everolimus is non-inferior to MPA if the upper limit of the 95% confidence interval for the difference in combined graft loss, death or loss to follow-up rates is \<10%.||5.2|-4.6|<0.001
72504915|NCT04329923|144540890|SUPERIORITY||Cox Proportional Hazard|0.58||||0.28|TWO_SIDED||||||Regression, Cox|||||||0.28
72379401|NCT00251004|144267066|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin was set at 10%.|Difference in percentage|1.8||||0.014|TWO_SIDED|95.0|-5.5|9.1||To control for multiple comparisons, the two-sided significance level was set at 0.025.|Z - test|||Everolimus is non-inferior to mycophenolic acid (MPA) if the upper limit of the 95% confidence interval for the difference in percentage of participants composite efficacy failure is \<10%.||9.1|-5.5|0.014
72379402|NCT00251004|144267066|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin was set at 10%.|Difference in percentage|-3.8|||<|0.001|TWO_SIDED|95.0|-10.8|3.3||To control for multiple comparisons, the two-sided significance level was set at 0.025.|Z-test|||Everolimus is non-inferior to MPA if the upper limit of the 95% confidence interval for the difference in composite efficacy failure rates is \<10%.||3.3|-10.8|<0.001
72379403|NCT00251004|144267067|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin was set at -8 mL/min/1.73m\^2.|Mean Difference (Net)|2.42|||<|0.001|TWO_SIDED|95.0|-1.6|6.5||To control for multiple comparisons, the two-sided significance level was set at 0.025.|t-test, 2 sided|||The null hypothesis: the mean GFR of the everolimus arm is lower (worse) than that of the MPA arm by 8 mL/min/1.73m\^2 or more.||6.5|-1.6|<0.001
72379404|NCT00251004|144267067|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin was set at -8 mL/min/1.73m\^2.|Mean Difference (Net)|-0.83|||<|0.001|TWO_SIDED|95.0|-4.9|3.3||To control for multiple comparisons, the two-sided significance level was set at 0.025.|t-test, 2 sided|||The null hypothesis: the mean GFR of the everolimus arm is lower (worse) than that of the MPA arm by 8 mL/min/1.73m\^2 or more.||3.3|-4.9|<0.001
72379405|NCT01723696|144267070|SUPERIORITY||Mean Difference (Final Values)|12.1||||0.19|TWO_SIDED|95.0|-6.1|30.3||P-value adjusted for design factors of site, gestational age at randomization and covariates of length, race, and sex of infant.|ANCOVA|||Our targeted sample size of 218 infants with successful FEFs at 3 months of age was determined to detect with 90% power, at a significance level of 0.05, increases of 15% in mean FEF75 in the vitamin C group compared to the placebo group.||30.3|-6.1|0.19
72379406|NCT02021656|144267073|SUPERIORITY||||||<|0.001|||||||Binomial Exact Test|||A sample size of 100 Chinese participants in the treatment naive group provided at least 90% power to detect a 17% improvement in SVR12 rate from the historical control rate of 57% using 2-sided exact one-sample binomial test at significant level of 0.05.||||<0.001
72379407|NCT02043379|144267080|NON_INFERIORITY_OR_EQUIVALENCE|We used alpha level of 0.05 and power of 0.8 to calculate the sample size necessary to detect a meaningful clinical difference for our primary endpoint.||||||1||||||A p-value of \<0.05 represents the threshold for statistical significance.|Chi-squared|||||||1
72379408|NCT02043379|144267081|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation.||||||1||||||A p-value of \<0.05 represents the threshold for statistical significance.|Chi-squared|||||||1
72379409|NCT02043379|144267082|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation.||||||0.38||||||A p-value of \<0.05 represents the threshold for statistical significance.|Chi-squared|||||||0.38
72379410|NCT02043379|144267083|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation.||||||0.26||||||A p-value of \<0.05 represents the threshold for statistical significance.|Chi-squared|||||||0.26
72379411|NCT02043379|144267084|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation||||||0.42|TWO_SIDED|95.0||||A p-value of \<0.05 represents the threshold for statistical significance.|t-test, 2 sided|||24 hour post-CPB albumin||||0.42
72379412|NCT02043379|144267084|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation||||||0.06||||||a p-value of \<0.05 represents the threshold for test signficance|t-test, 2 sided|||48 hour post CPB albumin||||0.06
72379413|NCT02043379|144267085|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation.||||||0.52||||||A p-value of \<0.05 represents the threshold for statistical significance.|Wilcoxon (Mann-Whitney)|||||||0.52
72379414|NCT02043379|144267086|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation.||||||0.81||||||A p-value of \<0.05 represents the threshold for statistical significance.|Wilcoxon (Mann-Whitney)|||Admit Inotrope Score||||0.81
72379415|NCT02043379|144267086|NON_INFERIORITY_OR_EQUIVALENCE|power calculations were not performed on this statistical calculation||||||0.82||||||a p value of \<0.05 represents the threshold for statistical significance|Wilcoxon (Mann-Whitney)|||12 hours post-operative inotrope score||||0.82
72379416|NCT02043379|144267086|NON_INFERIORITY_OR_EQUIVALENCE|power calculations were not performed on this statistical calculation||||||0.9||||||a p value of \<0.05 represents the threshold for statistical significance|Wilcoxon (Mann-Whitney)|||24 hours post-operative inotrope score||||0.9
72379417|NCT02043379|144267086|NON_INFERIORITY_OR_EQUIVALENCE|power calculations were not performed on this statistical calculation||||||0.23||||||a p-value of \<0.05 represents the threshold for statistical signficance|Wilcoxon (Mann-Whitney)|||48 hours post-operative inotrope score||||0.23
72379418|NCT02043379|144267087|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation.||||||0.49||||||A p-value of \<0.05 represents the threshold for statistical significance.|Wilcoxon (Mann-Whitney)|||||||0.49
72379419|NCT02043379|144267088|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation.||||||0.79||||||A p-value of \<0.05 represents the threshold for statistical significance.|Wilcoxon (Mann-Whitney)|||||||0.79
72379420|NCT02043379|144267089|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation.||||||0.32||||||A p-value of \<0.05 represents the threshold for statistical significance.|t-test, 2 sided|||pre-operative IgG level||||0.32
72379421|NCT02043379|144267089|NON_INFERIORITY_OR_EQUIVALENCE|power calculations were not performed on this statistical calculation||||||0.36||||||a p-value of \<0.05 represents the threshold for statistical significance|Wilcoxon (Mann-Whitney)|||12 hours post-operative IgG level||||0.36
72379422|NCT02043379|144267089|NON_INFERIORITY_OR_EQUIVALENCE|power calculations were not performed on this statistical calculation|||||<|0.01||||||p-value of \<0.05 represents the threshold for statistical signficance|Wilcoxon (Mann-Whitney)|||post-operative day 3 (72 hours) IgG level||||<0.01
72379423|NCT02043379|144267089|NON_INFERIORITY_OR_EQUIVALENCE|power calculations were not performed on this statistical calculation|||||<|0.01||||||p-value of \<0.05 represents the threshold for statistical significance|Wilcoxon (Mann-Whitney)|||post-operative day 5 (120 hours) IgG level||||<0.01
72379424|NCT02043379|144267090|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation||||||0.6||||||A p-value of \<0.05 represents the threshold for statistical significance.|Wilcoxon (Mann-Whitney)|||pre-operative||||0.60
72379425|NCT02043379|144267090|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation||||||0.06||||||A p-value of \<0.05 represents the threshold for statistical significance|Wilcoxon (Mann-Whitney)|||0 hour post-operative||||0.06
72379426|NCT02043379|144267090|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation||||||0.06||||||A p-value of \<0.05 represents the threshold for statistical significance|Wilcoxon (Mann-Whitney)|||4 hour post-operative||||0.06
72379427|NCT02043379|144267090|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation||||||0.33||||||A p-value of \<0.05 represents the threshold for statistical significance|Wilcoxon (Mann-Whitney)|||12 hours post-operative||||0.33
72379428|NCT02043379|144267090|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation||||||0.05||||||A p-value of \<0.05 represents the threshold for statistical significance|Wilcoxon (Mann-Whitney)|||24 hours post-operative||||0.05
72379429|NCT02043379|144267090|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation||||||0.83||||||A p-value of \<0.05 represents the threshold for statistical significance|Wilcoxon (Mann-Whitney)|||48 hours post-operative||||0.83
72379430|NCT02043379|144267091|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation||||||0.27||||||A p-value of \<0.05 represents the threshold for statistical significance.|Wilcoxon (Mann-Whitney)|||0 hour levels||||0.27
72379431|NCT02043379|144267091|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation||||||0.34||||||A p-value of \<0.05 represents the threshold for statistical significance.|Wilcoxon (Mann-Whitney)|||4 hour level||||0.34
72379432|NCT02043379|144267091|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation||||||0.14||||||A p-value of \<0.05 represents the threshold for statistical significance.|Wilcoxon (Mann-Whitney)|||8 hour level||||0.14
72379433|NCT02043379|144267091|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation||||||0.13||||||A p-value of \<0.05 represents the threshold for statistical significance.|Wilcoxon (Mann-Whitney)|||12 hour level||||0.13
72379434|NCT02043379|144267091|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation||||||0.02||||||A p-value of \<0.05 represents the threshold for statistical significance.|Wilcoxon (Mann-Whitney)|||24 hour level||||0.02
72379435|NCT02043379|144267092|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation.||||||1||||||A p-value of \<0.05 represents the threshold for statistical significance.|Chi-squared|||||||1
72379436|NCT02043379|144267093|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation.||||||0.4||||||A p-value of \<0.05 represents the threshold for statistical significance.|Wilcoxon (Mann-Whitney)|||||||0.4
72556330|NCT00862563|144643981|SUPERIORITY_OR_OTHER||Difference between least squares means|-19.3|STANDARD_DEVIATION|8.0||0.017|TWO_SIDED|||||p\<0.05 is considered to be significant|ANOVA|||Comparison of Week 10 means for mean percent drinking days obtained for the placebo and levetiracetam groups. Means used for the analysis are least squares means from a two-way repeated measures mixed models analysis. Baseline values were used as covariates.||||0.017
72379437|NCT02043379|144267094|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation.||||||0.09||||||A p-value of \<0.05 represents the threshold for statistical significance.|Wilcoxon (Mann-Whitney)|||0-48 hours post-CPB||||0.09
72379438|NCT02043379|144267094|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation.||||||0.52||||||A p-value of \<0.05 represents the threshold for statistical significance.|Wilcoxon (Mann-Whitney)|||0-24 hours post CPB||||0.52
72379439|NCT02043379|144267095|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation.||||||0.72||||||A p-value of \<0.05 represents the threshold for statistical significance.|Wilcoxon (Mann-Whitney)|||||||0.72
72379440|NCT02043379|144267096|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation.||||||0.63||||||A p-value of \<0.05 represents the threshold for statistical significance.|Wilcoxon (Mann-Whitney)|||||||0.63
72379441|NCT02043379|144267097|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation.||||||0.41||||||A p-value of \<0.05 represents the threshold for statistical significance.|Wilcoxon (Mann-Whitney)|||pre-operative||||0.41
72379442|NCT02043379|144267097|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation||||||0.34||||||A p-value of \<0.05 represents the threshold for statistical significance|Wilcoxon (Mann-Whitney)|||0 hour post-operative||||0.34
72379443|NCT02043379|144267097|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation||||||0.47||||||A p-value of \<0.05 represents the threshold for statistical significance|Wilcoxon (Mann-Whitney)|||4 hour post-operative||||0.47
72379444|NCT02043379|144267097|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation||||||0.42||||||A p-value of \<0.05 represents the threshold for statistical significance|Wilcoxon (Mann-Whitney)|||12 hour post-operative||||0.42
72379445|NCT02043379|144267097|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation||||||0.82||||||A p-value of \<0.05 represents the threshold for statistical significance|Wilcoxon (Mann-Whitney)|||24 hour post-operative||||0.82
72379446|NCT02043379|144267097|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation||||||0.44||||||A p-value of \<0.05 represents the threshold for statistical significance|Wilcoxon (Mann-Whitney)|||48 hour post-operative||||0.44
72379447|NCT02043379|144267098|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation.||||||0.28||||||A p-value of \<0.05 represents the threshold for statistical significance.|Wilcoxon (Mann-Whitney)|||pre-operative||||0.28
72379448|NCT02043379|144267098|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation||||||0.37||||||A p-value of \<0.05 represents the threshold for statistical significance|Wilcoxon (Mann-Whitney)|||0 hour post-operative||||0.37
72379449|NCT02043379|144267098|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation||||||0.42||||||A p-value of \<0.05 represents the threshold for statistical significance|Wilcoxon (Mann-Whitney)|||4 hour post-operative||||0.42
72379450|NCT02043379|144267098|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation||||||0.31||||||A p-value of \<0.05 represents the threshold for statistical significance|Wilcoxon (Mann-Whitney)|||12 hour post-operative||||0.31
72379451|NCT02043379|144267098|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation||||||0.38||||||A p-value of \<0.05 represents the threshold for statistical significance|Wilcoxon (Mann-Whitney)|||24 hour post-operative||||0.38
72379452|NCT02043379|144267098|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation||||||0.4||||||A p-value of \<0.05 represents the threshold for statistical significance|Wilcoxon (Mann-Whitney)|||48 hour post-operative||||0.4
72379453|NCT02043379|144267099|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation.||||||0.1||||||A p-value of \<0.05 represents the threshold for statistical significance.|Wilcoxon (Mann-Whitney)|||pre-operative||||0.1
72379454|NCT02043379|144267099|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation||||||0.12||||||A p-value of \<0.05 represents the threshold for statistical significance|Wilcoxon (Mann-Whitney)|||0 hour post-operative||||0.12
72379455|NCT02043379|144267099|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation||||||0.51||||||A p-value of \<0.05 represents the threshold for statistical significance|Wilcoxon (Mann-Whitney)|||4 hour post-operative||||0.51
72379456|NCT02043379|144267099|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation||||||0.27||||||A p-value of \<0.05 represents the threshold for statistical significance|Wilcoxon (Mann-Whitney)|||12 hour post-operative||||0.27
72379457|NCT02043379|144267099|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation||||||0.88||||||A p-value of \<0.05 represents the threshold for statistical significance|Wilcoxon (Mann-Whitney)|||24 hour post-operative||||0.88
72379458|NCT02043379|144267099|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation||||||0.38||||||A p-value of \<0.05 represents the threshold for statistical significance|Wilcoxon (Mann-Whitney)|||48 hour post-operative||||0.38
72379459|NCT02043379|144267100|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation.||||||0.35||||||A p-value of \<0.05 represents the threshold for statistical significance.|Wilcoxon (Mann-Whitney)|||pre-operative||||0.35
72379460|NCT02043379|144267100|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation||||||0.39||||||A p-value of \<0.05 represents the threshold for statistical significance|Wilcoxon (Mann-Whitney)|||0 hour post-operative||||0.39
72379461|NCT02043379|144267100|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation||||||0.58||||||A p-value of \<0.05 represents the threshold for statistical significance|Wilcoxon (Mann-Whitney)|||4 hour post-operative||||0.58
72379462|NCT02043379|144267100|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation||||||0.36||||||A p-value of \<0.05 represents the threshold for statistical significance|Wilcoxon (Mann-Whitney)|||12 hour post-operative||||0.36
72379463|NCT02043379|144267100|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation||||||0.61||||||A p-value of \<0.05 represents the threshold for statistical significance|Wilcoxon (Mann-Whitney)|||24 hour post-operative||||0.61
72379464|NCT02043379|144267100|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation||||||0.38||||||A p-value of \<0.05 represents the threshold for statistical significance|Wilcoxon (Mann-Whitney)|||48 hour post-operative||||0.38
72379465|NCT02043379|144267101|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation.||||||0.1||||||A p-value of \<0.05 represents the threshold for statistical significance.|Wilcoxon (Mann-Whitney)|||pre-operative||||0.1
72379466|NCT02043379|144267101|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation||||||0.02||||||A p-value of \<0.05 represents the threshold for statistical significance|Wilcoxon (Mann-Whitney)|||0 hour post-operative||||0.02
72379467|NCT02043379|144267101|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation||||||0.34||||||A p-value of \<0.05 represents the threshold for statistical significance|Wilcoxon (Mann-Whitney)|||4 hour post-operative||||0.34
72618528|NCT01026038|144768103|SUPERIORITY_OR_OTHER||GMC ratio|1.03|||||TWO_SIDED|95.0|0.81|1.3||||||Serotype 7F: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.30|0.81|
72379468|NCT02043379|144267101|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation||||||0.35||||||A p-value of \<0.05 represents the threshold for statistical significance|Wilcoxon (Mann-Whitney)|||12 hour post-operative||||0.35
72379469|NCT02043379|144267101|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation||||||0.67||||||A p-value of \<0.05 represents the threshold for statistical significance|Wilcoxon (Mann-Whitney)|||24 hour post-operative||||0.67
72379470|NCT02043379|144267101|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation||||||0.47||||||A p-value of \<0.05 represents the threshold for statistical significance|Wilcoxon (Mann-Whitney)|||48 hour post-operative||||0.47
72379471|NCT02043379|144267102|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation||||||0.46||||||A p-value of \<0.05 represents the threshold for statistical significance.|Wilcoxon (Mann-Whitney)|||pre-operative||||0.46
72379472|NCT02043379|144267102|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation||||||0.04||||||A p-value of \<0.05 represents the threshold for statistical significance|Wilcoxon (Mann-Whitney)|||0 hour post-operative||||0.04
72379473|NCT02043379|144267102|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation||||||0.14||||||A p-value of \<0.05 represents the threshold for statistical significance|Wilcoxon (Mann-Whitney)|||4 hour post-operative||||0.14
72379474|NCT02043379|144267102|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation||||||0.82||||||A p-value of \<0.05 represents the threshold for statistical significance|Wilcoxon (Mann-Whitney)|||12 hour post-operative||||0.82
72379475|NCT02043379|144267102|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation||||||0.9||||||A p-value of \<0.05 represents the threshold for statistical significance|Wilcoxon (Mann-Whitney)|||24 hour post-operative||||0.9
72556331|NCT00862563|144643981|SUPERIORITY_OR_OTHER||Difference between least squares means|-31.2|STANDARD_ERROR_OF_MEAN|8.1||0.0002|TWO_SIDED|||||p\<0.05 is considered to be significant.|ANOVA|||Comparison of Week 11 means for mean percent drinking days obtained for the placebo and levetiracetam groups. Means used for the analysis are least squares means from a two-way repeated measures mixed models analysis. Baseline values were used as covariates.||||0.0002
72379476|NCT02043379|144267102|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation||||||0.78||||||A p-value of \<0.05 represents the threshold for statistical significance|Wilcoxon (Mann-Whitney)|||48 hour post-operative||||0.78
72379477|NCT02043379|144267103|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation.||||||0.37||||||A p-value of \<0.05 represents the threshold for statistical significance.|Wilcoxon (Mann-Whitney)|||0 hour level||||0.37
72379478|NCT02043379|144267103|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation||||||0.47||||||A p-value of \<0.05 represents the threshold for statistical significance.|Wilcoxon (Mann-Whitney)|||4 hour level||||0.47
72379479|NCT02043379|144267103|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation||||||0.47||||||A p-value of \<0.05 represents the threshold for statistical significance.|Wilcoxon (Mann-Whitney)|||8 hour level||||0.47
72379480|NCT02043379|144267103|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation||||||0.79||||||A p-value of \<0.05 represents the threshold for statistical significance.|Wilcoxon (Mann-Whitney)|||12 hour level||||0.79
72379481|NCT02043379|144267103|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation||||||0.04||||||A p-value of \<0.05 represents the threshold for statistical significance.|Wilcoxon (Mann-Whitney)|||24 hour level||||0.04
72379482|NCT02043379|144267104|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation.||||||0.43||||||A p-value of \<0.05 represents the threshold for statistical significance.|t-test, 2 sided|||pre-operative||||0.43
72379483|NCT02043379|144267104|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation||||||0.68||||||A p-value of \<0.05 represents the threshold for statistical significance|t-test, 2 sided|||max||||0.68
72379484|NCT02043379|144267105|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation.||||||0.87||||||A p-value of \<0.05 represents the threshold for statistical significance.|t-test, 2 sided|||pre-operative||||0.87
72379485|NCT02043379|144267105|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation||||||0.79||||||A p-value of \<0.05 represents the threshold for statistical significance|t-test, 2 sided|||24 hour post-operative max||||0.79
72379486|NCT00282347|144267106|SUPERIORITY_OR_OTHER|||||||0.5538|TWO_SIDED||||||Stratified Wilcoxon-Rank Sum Test|||||||0.5538
72379487|NCT00491556|144267120|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.08|STANDARD_DEVIATION|5.13|<|0.0001|TWO_SIDED|95.0|-12.2|-7.97|||t-test, 2 sided||Difference was calculated as Baseline minus Week 48|Null hypothesis is no changes between Baseline and Week 48.||-7.97|-12.20|<0.0001
72379488|NCT00491556|144267121|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.81|STANDARD_DEVIATION|5.0||0.0834|TWO_SIDED|95.0|-3.87|0.26|||t-test, 2 sided||Difference was calculated as Week 48 minus Week 152|Null hypothesis is no changes between Week 48 and Week 152||0.26|-3.87|0.0834
72379489|NCT00491556|144267122|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-317.36|STANDARD_DEVIATION|176.07|<|0.0001|TWO_SIDED|95.0|-390.04|-244.68|||t-test, 2 sided||Difference was calculated as Baseline minus Week 48|Null hypothesis is no changes between Baseline and Week 48.||-244.68|-390.04|<0.0001
72379490|NCT00491556|144267123|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-24.2|STANDARD_DEVIATION|242.38||0.6222|TWO_SIDED|95.0|-124.25|75.85|||t-test, 2 sided||Difference was calculated as Week 48 minus Week 152|Null hypothesis is no changes between Week 48 and Week 152||75.85|-124.25|0.6222
72379491|NCT00491556|144267124|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-58.79|STANDARD_DEVIATION|152.57||0.0781|TWO_SIDED|95.0|-124.77|7.18|||t-test, 2 sided|||Null hypothesis is no changes between Baseline and Week 48.||7.18|-124.77|0.0781
72379492|NCT00491556|144267125|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-103.53|STANDARD_DEVIATION|176.61||0.0102|TWO_SIDED|95.0|-179.9|-27.16|||t-test, 2 sided|||Null hypothesis is no changes between Week 48 and Week 152||-27.16|-179.90|0.0102
72556332|NCT00862563|144643981|SUPERIORITY_OR_OTHER||Difference between least squares means|-18.5|STANDARD_ERROR_OF_MEAN|8.2||0.026|TWO_SIDED|||||p\< 0.05 is considered to be significant|ANOVA|||.Comparison of Week 12 means for mean percent drinking days obtained for the placebo and levetiracetam groups. Means used for the analysis are least squares means from a two-way repeated measures mixed models analysis.Baseline values were used as covariates.||||0.026
72379493|NCT00491556|144267126|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.13|STANDARD_DEVIATION|56.72||0.1616|TWO_SIDED|95.0|-41.66|7.4|||t-test, 2 sided||Difference was calculated as Baseline minus Week 48|Null hypothesis is no changes between Baseline and Week 48.||7.40|-41.66|0.1616
72379494|NCT00491556|144267127|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-43.08|STANDARD_DEVIATION|75.17||0.0117|TWO_SIDED|95.0|-75.59|-10.58|||t-test, 2 sided||Difference was calculated as Week 48 minus Week 152|Null hypothesis is no changes between Week 48 and Week 152||-10.58|-75.59|0.0117
72379495|NCT00491556|144267128|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-76.92|STANDARD_DEVIATION|56.31|<|0.0001|TWO_SIDED|95.0|-101.27|-52.57|||t-test, 2 sided||Difference was calculated as Baseline minus Week 48|Null hypothesis is no changes between Week 48 and Week 152||-52.57|-101.27|< 0.0001
72379496|NCT00491556|144267129|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.87|STANDARD_DEVIATION|68.75||0.2519|TWO_SIDED|95.0|-12.86|46.6|||t-test, 2 sided||Difference was calculated as Week 48 minus Week 152|Null hypothesis is no changes between Week 48 and Week 152||46.60|-12.86|0.2519
72379497|NCT00491556|144267130|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-126.79|STANDARD_DEVIATION|105.61|<|0.0001|TWO_SIDED|95.0|-172.46|-81.12|||t-test, 2 sided||Difference was calculated as Baseline minus Week 48.|Null hypothesis is no changes between Baseline and Week 48.||-81.12|-172.46|< 0.0001
72379498|NCT00491556|144267131|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|87.64|STANDARD_DEVIATION|97.71||0.0003|TWO_SIDED|95.0|45.39|129.9|||t-test, 2 sided||Difference was calculated as Week 48 minus Week 152.|Null hypothesis is no changes between Week 48 and Week 152.||129.90|45.39|0.0003
72379499|NCT00491556|144267132|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|40.46|STANDARD_DEVIATION|213.77||0.3739|TWO_SIDED|95.0|-51.98|132.9|||t-test, 2 sided||Difference was calculated as Baseline minus Week 48.|Null hypothesis is no changes between Baseline and Week 48.||132.90|-51.98|0.3739
72379500|NCT00491556|144267133|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-91.86|STANDARD_DEVIATION|166.4||0.0147|TWO_SIDED|95.0|-163.82|-19.9|||t-test, 2 sided||Difference was calculated as Week 48 minus Week 152.|Null hypothesis is no changes between Week 48 and Week 152.||-19.90|-163.82|0.0147
72379501|NCT00491556|144267134|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|79.81|STANDARD_DEVIATION|76.07|<|0.0001|TWO_SIDED|95.0|46.92|112.71|||t-test, 2 sided||Difference was calculated as Baseline minus Week 48.|Null hypothesis is no changes between Baseline and Week 48.||112.71|46.92|< 0.0001
72379502|NCT00491556|144267135|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-20.4|STANDARD_DEVIATION|58.18||0.1067|TWO_SIDED|95.0|-45.56|4.76|||t-test, 2 sided||Difference was calculated as Week 48 minus Week 152.|Null hypothesis is no changes between Week 48 and Week 152.||4.76|-45.56|0.1067
72379503|NCT00491556|144267136|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|90.82|STANDARD_DEVIATION|107.8||0.0005|TWO_SIDED|95.0|44.2|137.43|||t-test, 2 sided||Difference was calculated as Baseline minus Week 48.|Null hypothesis is no changes between Baseline and Week 48.||137.43|44.20|0.0005
72379504|NCT00491556|144267137|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|33.49|STANDARD_DEVIATION|64.41||0.0207|TWO_SIDED|95.0|5.64|61.34|||t-test, 2 sided||Difference was calculated as Week 48 minus Week 152.|Null hypothesis is no changes between Week 48 and Week 152.||61.34|5.64|0.0207
72379505|NCT00491556|144267138|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-39.37|STANDARD_DEVIATION|145.62||0.2082|TWO_SIDED|95.0|-102.34|23.6|||t-test, 2 sided||Difference was calculated as Baseline minus Week 48.|Null hypothesis is no changes between Week 48 and Week 152.||23.60|-102.34|0.2082
72379506|NCT00491556|144267139|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|86.98|STANDARD_DEVIATION|139.33||0.0067|TWO_SIDED|95.0|26.73|147.23|||t-test, 2 sided||Difference was calculated as Week 48 minus Week 152.|Null hypothesis is no changes between Week 48 and Week 152.||147.23|26.73|0.0067
72379507|NCT00491556|144267140|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-18.07|STANDARD_DEVIATION|13.2|<|0.0001|TWO_SIDED|95.0|-23.78|-12.36|||t-test, 2 sided||Difference was calculated as Baseline minus Week 48.|Null hypothesis is no changes between Baseline and Week 48.||-12.36|-23.78|< 0.0001
72379508|NCT00491556|144267141|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.66|STANDARD_DEVIATION|14.2||0.5815|TWO_SIDED|95.0|-4.48|7.8|||t-test, 2 sided||Difference was calculated as Week 48 minus Week 152.|Null hypothesis is no changes between Week 48 and Week 152.||7.80|-4.48|0.5815
72379509|NCT00491556|144267142|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.24|STANDARD_DEVIATION|7.82|<|0.0001|TWO_SIDED|95.0|7.85|14.62|||t-test, 2 sided||Difference was calculated as Baseline minus Week 48.|Null hypothesis is no changes between Baseline and Week 48.||14.62|7.85|< 0.0001
72379510|NCT00491556|144267143|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.87|STANDARD_DEVIATION|6.93||0.0594|TWO_SIDED|95.0|-5.87|0.12|||t-test, 2 sided||Difference was calculated as Week 48 minus Week 152.|Null hypothesis is no changes between Week 48 and Week 152.||0.12|-5.87|0.0594
72379511|NCT00491556|144267144|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.58|STANDARD_DEVIATION|10.24||0.0001|TWO_SIDED|95.0|8.15|17.01|||t-test, 2 sided||Difference was calculated as Baseline minus Week 48.|Null hypothesis is no changes between Baseline and Week 48.||17.01|8.15|0.0001
72379512|NCT00491556|144267145|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.93|STANDARD_DEVIATION|10.95||0.0995|TWO_SIDED|95.0|-0.81|8.66|||t-test, 2 sided||Difference was calculated as Week 48 minus Week 152.|Null hypothesis is no changes between Week 48 and Week 152.||8.66|-0.81|0.0995
72379513|NCT00491556|144267146|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.95|STANDARD_DEVIATION|2.07||0.0002|TWO_SIDED|95.0|1.05|2.84|||t-test, 2 sided||Difference was calculated as Baseline minus Week 48.|Null hypothesis is no changes between Baseline and Week 48.||2.84|1.05|0.0002
72379514|NCT00491556|144267147|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.03|STANDARD_DEVIATION|1.49||0.915|TWO_SIDED|95.0|-0.61|0.68|||t-test, 2 sided||Difference was calculated as Week 48 minus Week 152.|Null hypothesis is no changes between Week 48 and Week 152.||0.68|-0.61|0.9150
72379515|NCT00491556|144267148|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-23.52|STANDARD_DEVIATION|13.79|<|0.0001|TWO_SIDED|95.0|-29.48|-17.55|||t-test, 2 sided||Difference was calculated as Baseline minus Week 48.|Null hypothesis is no changes between Baseline and Week 48.||-17.55|-29.48|< 0.0001
72379516|NCT00491556|144267149|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.95|STANDARD_DEVIATION|16.96||0.5864|TWO_SIDED|95.0|-5.38|9.28|||t-test, 2 sided||Difference was calculated as Week 48 minus Week 152.|Null hypothesis is no changes between Week 48 and Week 152.||9.28|-5.38|0.5864
72379517|NCT00491556|144267150|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|21.98|STANDARD_DEVIATION|8.48|<|0.0001|TWO_SIDED|95.0|18.31|25.65|||t-test, 2 sided||Difference was calculated as Baseline minus Week 48.|Null hypothesis is no changes between Baseline and Week 48.||25.65|18.31|< 0.0001
72618529|NCT01026038|144768103|SUPERIORITY_OR_OTHER||GMC ratio|0.63|||||TWO_SIDED|95.0|0.47|0.83||||||Serotype 7F: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||0.83|0.47|
72379518|NCT00491556|144267151|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.2|STANDARD_DEVIATION|7.25||0.1592|TWO_SIDED|95.0|-5.34|0.93|||t-test, 2 sided||Difference was calculated as Week 48 minus Week 152.|Null hypothesis is no changes between Week 48 and Week 152.||0.93|-5.34|0.1592
72379519|NCT00491556|144267152|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.97|STANDARD_DEVIATION|11.04||0.042|TWO_SIDED|95.0|0.2|9.74|||t-test, 2 sided||Difference was calculated as Baseline minus Week 48.|Null hypothesis is no changes between Baseline and Week 48.||9.74|0.20|0.0420
72379520|NCT00491556|144267153|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.2|STANDARD_DEVIATION|12.39||0.4029|TWO_SIDED|95.0|-7.56|3.16|||t-test, 2 sided||Difference was calculated as Week 48 minus Week 152.|Null hypothesis is no changes between Week 48 and Week 152.||3.16|-7.56|0.4029
72379521|NCT00491556|144267154|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.6|STANDARD_DEVIATION|6.03|<|0.0001|TWO_SIDED|95.0|11.99|17.21|||t-test, 2 sided||Difference was calculated as Baseline minus Week 48.|Null hypothesis is no changes between Baseline and Week 48.||17.21|11.99|< 0.0001
72618530|NCT01026038|144768103|SUPERIORITY_OR_OTHER||GMC ratio|1.99|||||TWO_SIDED|95.0|1.51|2.63||||||Serotype 19A: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||2.63|1.51|
72379522|NCT00491556|144267155|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.14|STANDARD_DEVIATION|6.2||0.0239|TWO_SIDED|95.0|-5.81|-0.46|||t-test, 2 sided||Difference was calculated as Week 48 minus Week 152.|Null hypothesis is no changes between Week 48 and Week 152.||-0.46|-5.81|0.0239
72379523|NCT00491556|144267156|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.35|STANDARD_DEVIATION|10.26|<|0.0001|TWO_SIDED|95.0|-23.79|-14.91|||t-test, 2 sided||Difference was calculated as Baseline minus Week 48.|Null hypothesis is no changes between Baseline and Week 48.||-14.91|-23.79|< 0.0001
72379524|NCT00491556|144267157|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.45|STANDARD_DEVIATION|13.6||0.2363|TWO_SIDED|95.0|-9.33|2.43|||t-test, 2 sided||Difference was calculated as Week 48 minus Week 152.|Null hypothesis is no changes between Week 48 and Week 152.||2.43|-9.33|0.2363
72379525|NCT00491556|144267158|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|19.69|STANDARD_DEVIATION|8.7|<|0.0001|TWO_SIDED|95.0|15.93|23.45|||t-test, 2 sided||Difference was calculated as Baseline minus Week 48.|Null hypothesis is no changes between Baseline and Week 48.||23.45|15.93|< 0.0001
72379526|NCT00491556|144267159|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.03|STANDARD_ERROR_OF_MEAN|5.55||0.0929|TWO_SIDED|95.0|-4.43|0.37|||t-test, 2 sided||Difference was calculated as Week 48 minus Week 152.|Null hypothesis is no changes between Week 48 and Week 152.||0.37|-4.43|0.0929
72379527|NCT00491556|144267160|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.53|STANDARD_DEVIATION|8.94||0.1886|TWO_SIDED|95.0|-6.4|1.34|||t-test, 2 sided||Difference was calculated as Baseline minus Week 48.|Null hypothesis is no changes between Baseline and Week 48.||1.34|-6.40|0.1886
72379528|NCT00491556|144267161|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.87|STANDARD_DEVIATION|8.13||0.2831|TWO_SIDED|95.0|-1.65|5.38|||t-test, 2 sided||Difference was calculated as Week 48 minus Week 152.|Null hypothesis is no changes between Week 48 and Week 152.||5.38|-1.65|0.2831
72379529|NCT00491556|144267162|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.52|STANDARD_DEVIATION|5.59|<|0.0001|TWO_SIDED|95.0|9.1|13.94|||t-test, 2 sided||Difference was calculated as Baseline minus Week 48.|Null hypothesis is no changes between Baseline and Week 48.||13.94|9.10|< 0.0001
72379530|NCT00491556|144267163|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.21|STANDARD_DEVIATION|5.88||0.0157|TWO_SIDED|95.0|-5.75|-0.67|||t-test, 2 sided||Difference was calculated as Week 48 minus Week 152.|Null hypothesis is no changes between Week 48 and Week 152.||-0.67|-5.75|0.0157
72379531|NCT00491556|144267164|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-22.65|STANDARD_DEVIATION|12.93|<|0.0001|TWO_SIDED|95.0|-28.24|-17.06|||t-test, 2 sided||Difference was calculated as Baseline minus Week 48.|Null hypothesis is no changes between Baseline and Week 48.||-17.06|-28.24|< 0.0001
72379532|NCT00491556|144267165|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.23|STANDARD_DEVIATION|15.37||0.1999|TWO_SIDED|95.0|-2.41|10.88|||t-test, 2 sided||Difference was calculated as Week 48 minus Week 152.|Null hypothesis is no changes between Week 48 and Week 152.||10.88|-2.41|0.1999
72379533|NCT00491556|144267166|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.47|STANDARD_DEVIATION|6.81|<|0.0001|TWO_SIDED|95.0|9.52|15.41|||t-test, 2 sided||Difference was calculated as Baseline minus Week 48.|Null hypothesis is no changes between Baseline and Week 48.||15.41|9.52|< 0.0001
72379534|NCT00491556|144267167|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.95|STANDARD_DEVIATION|5.12||0.0808|TWO_SIDED|95.0|-4.17|0.26|||t-test, 2 sided||Difference was calculated as Week 48 minus Week 152.|Null hypothesis is no changes between Week 48 and Week 152.||0.26|-4.17|0.0808
72379535|NCT00491556|144267168|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.7|STANDARD_DEVIATION|13.83||0.0005|TWO_SIDED|95.0|5.72|17.69|||t-test, 2 sided||Difference was calculated as Baseline minus Week 48.|Null hypothesis is no changes between Baseline and Week 48.||17.69|5.72|0.0005
72379536|NCT00491556|144267169|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_DEVIATION|14.12||0.9198|TWO_SIDED|95.0|-6.41|5.81|||t-test, 2 sided||Difference was calculated as Week 48 minus Week 152.|Null hypothesis is no changes between Week 48 and Week 152.||5.81|-6.41|0.9198
72379537|NCT00491556|144267170|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.69|STANDARD_DEVIATION|2.97|<|0.0001|TWO_SIDED|95.0|2.4|4.97|||t-test, 2 sided||Difference was calculated as Baseline minus Week 48.|Null hypothesis is no changes between Baseline and Week 48.||4.97|2.40|< 0.0001
72433621|NCT00991276|144380375|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.42|STANDARD_ERROR_OF_MEAN|0.24|<|0.0001|TWO_SIDED|95.0|-1.9|-0.95||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||-0.95|-1.90|<0.0001
72618531|NCT01026038|144768103|SUPERIORITY_OR_OTHER||GMC ratio|1.04|||||TWO_SIDED|95.0|0.79|1.37||||||Serotype 19A: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.37|0.79|
72379538|NCT00491556|144267171|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.31|STANDARD_DEVIATION|2.54||0.0215|TWO_SIDED|95.0|-2.41|-0.21|||t-test, 2 sided||Difference was calculated as Week 48 minus Week 152.|Null hypothesis is no changes between Week 48 and Week 152.||-0.21|-2.41|0.0215
72379539|NCT04854642|144267174|OTHER||Least square mean difference|71.62|||<|0.0001|TWO_SIDED|90.0|68.13|75.29|||ANOVA|||||75.29|68.13|<0.0001
72379540|NCT04854642|144267175|OTHER||Least square mean difference|90.93||||0.017|TWO_SIDED|90.0|85.3|96.93|||ANOVA|||||96.93|85.30|0.0170
72379541|NCT04854642|144267176|OTHER||Least square mean difference|90.9||||0.0213|TWO_SIDED|90.0|85.04|97.16|||ANOVA|||||97.16|85.04|0.0213
72379542|NCT04854642|144267177|OTHER||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
72379543|NCT00562627|144267192|SUPERIORITY_OR_OTHER|||||||0.009||95.0|||||ANOVA|||||||0.009
72379544|NCT00562627|144267193|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||ANOVA|||||||0.001
72379545|NCT00562627|144267194|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA|||||||<0.001
72556333|NCT00862563|144643982|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||p\< 0.01 is considered to be significant.|Mixed Models Analysis|p value is for the group x time interaction term.'||Data were analyzed using two-way repeated measures mixed models analysis. It was hypothesized that COWAT-Letter Fluency scores would change towards a downward direction for the zonisamide as compared to the placebo group resulting in significant treatment x time interaction.||||<0.0001
72379546|NCT01709578|144267197|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.711|||<|0.0001|TWO_SIDED|95.0|1.73|4.247||Threshold for significance at 0.025 level|Mantel Haenszel||Sarilumab 150 mg q2w vs Placebo q2w|A hierarchical testing procedure was used to control type I error rate at 0.05 and handle multiple endpoint analyses. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when previous endpoint was statistically significant at 0.025 level.||4.247|1.730|<0.0001
72379547|NCT01709578|144267197|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.284|||<|0.0001|TWO_SIDED|95.0|2.108|5.115||Threshold for significance at 0.025 level|Mantel Haenszel||Sarilumab 200 mg q2w vs Placebo q2w|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||5.115|2.108|<0.0001
72379548|NCT01709578|144267198|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.202||||0.0007|TWO_SIDED|95.0|-0.318|-0.086||Threshold for significance at 0.025 level|Mixed Models Analysis||Sarilumab 150 mg q2w vs Placebo q2w|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-0.086|-0.318|0.0007
72379549|NCT01709578|144267198|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.21||||0.0004|TWO_SIDED|95.0|-0.325|-0.095||Threshold for significance at 0.025 level|Mixed Models Analysis||Sarilumab 200 mg q2w vs Placebo q2w|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-0.095|-0.325|0.0004
72379550|NCT01709578|144267199|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.971|||<|0.0001|TWO_SIDED|95.0|-1.283|-0.658||Threshold for significance at 0.025 level|Mixed Models Analysis||Sarilumab 150 mg q2w vs Placebo q2w|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-0.658|-1.283|<0.0001
72379551|NCT01709578|144267199|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.444|||<|0.0001|TWO_SIDED|95.0|-1.752|-1.135||Threshold for significance at 0.025 level|Mixed Models Analysis||Sarilumab 200 mg q2w vs Placebo q2w|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-1.135|-1.752|<0.0001
72379552|NCT01709578|144267200|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.958|||<|0.0001|TWO_SIDED|95.0|1.764|4.959||Threshold for significance at 0.025 level|Mantel Haenszel||Sarilumab 150 mg q2w vs Placebo q2w|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||4.959|1.764|<0.0001
72379553|NCT01709578|144267200|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.374|||<|0.0001|TWO_SIDED|95.0|2.045|5.566||Threshold for significance was 0.025 level|Mantel Haenszel||Sarilumab 200 mg q2w vs Placebo q2w|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||5.566|2.045|<0.0001
72379554|NCT01709578|144267201|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.607||||0.0002|TWO_SIDED|95.0|1.774|7.332||Threshold for significance at 0.025 level|Mantel Haenszel||Sarilumab 150 mg q2w vs Placebo q2w|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||7.332|1.774|0.0002
72379555|NCT01709578|144267201|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.653||||0.0056|TWO_SIDED|95.0|1.308|5.383||Threshold for significance at 0.025 level|Mantel Haenszel||Sarilumab 200 mg q2w vs Placebo q2w|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||5.383|1.308|0.0056
72379556|NCT01709578|144267202|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.622|||<|0.0001|TWO_SIDED|95.0|2.339|9.132||Threshold for significance at 0.025 level|Mantel Haenszel||Sarilumab 150 mg q2w vs Placebo q2w|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||9.132|2.339|<0.0001
72379557|NCT01709578|144267202|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.801|||<|0.0001|TWO_SIDED|95.0|2.948|11.413||Threshold for significance at 0.025 level|Mantel Haenszel||Sarilumab 200 mg q2w vs Placebo q2w|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||11.413|2.948|<0.0001
72379558|NCT01709578|144267203|SUPERIORITY_OR_OTHER||LS Mean Difference|-7.306|||<|0.0001|TWO_SIDED|95.0|-10.444|-4.167||Threshold for significance at 0.025 level|Mixed Models Analysis||Sarilumab 150 mg q2w vs Placebo q2w|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-4.167|-10.444|<0.0001
72379559|NCT01709578|144267203|SUPERIORITY_OR_OTHER||LS Mean Difference|-9.727|||<|0.0001|TWO_SIDED|95.0|-12.833|-6.622||Threshold for significance at 0.025 level|Mixed Models Analysis||Sarilumab 200 mg q2w vs Placebo q2w|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-6.622|-12.833|<0.0001
72379560|NCT01709578|144267204|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.183||||0.0078|TWO_SIDED|95.0|-0.318|-0.048||Threshold for significance was 0.025 level|Mixed Models Analysis||Sarilumab 150 mg q2w vs Placebo q2w|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-0.048|-0.318|0.0078
72493939|NCT03178487|144516782|SUPERIORITY|To preserve the overall type I error rate at α=0.05 level, a step-down approach was used to test the primary and multiplicity-controlled key secondary endpoints. The testing began with the primary endpoint at α=0.05 and continued conditional on significance of higher-ranked endpoint. The testing sequence included a group of endpoints tested by the Hochberg procedure, including BASFI; within the group, the allocated α was adjusted based on the magnitude of p values.|LS Mean Difference|-1.0||||0.001|TWO_SIDED|95.0|-1.6|-0.39|||Mixed Effect Model Repeated Measurement|MMRM model includes treatment, visit, treatment-by-visit interaction as fixed effects and Screening hsCRP level and Baseline value as covariates.|Treatment difference = Upadacitinib - Placebo|||-0.39|-1.60|0.001
72618532|NCT01026038|144768103|SUPERIORITY_OR_OTHER||GMC ratio|0.52|||||TWO_SIDED|95.0|0.38|0.72||||||Serotype 19A: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||0.72|0.38|
72618533|NCT01026038|144768104|SUPERIORITY_OR_OTHER||||||>|0.99|||||||Fisher Exact|||Pain (Any): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/7vPnC/13vPnC.||||>0.990
72379561|NCT01709578|144267204|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.242||||0.0004|TWO_SIDED|95.0|-0.376|-0.109||Threshold for significance was 0.025 level|Mixed Models Analysis||Sarilumab 200 mg q2w vs Placebo q2w|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-0.109|-0.376|0.0004
72379562|NCT01709578|144267205|SUPERIORITY_OR_OTHER||LS Mean Difference|3.25||||0.0004|TWO_SIDED|95.0|1.45|5.049||Threshold for significance at 0.025 level|Mixed Models Analysis||Sarilumab 150 mg q2w vs Placebo q2w|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||5.049|1.450|0.0004
72379563|NCT01709578|144267205|SUPERIORITY_OR_OTHER||LS Mean Difference|4.075|||<|0.0001|TWO_SIDED|95.0|2.305|5.846||Threshold for significance at 0.025 level|Mixed Models Analysis||Sarilumab 200 mg q2w vs Placebo q2w|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||5.846|2.305|<0.0001
72379564|NCT01709578|144267206|SUPERIORITY_OR_OTHER||LS Mean Difference|1.515||||0.2026|TWO_SIDED|95.0|-0.818|3.848||Threshold for significance at 0.025 level|Mixed Models Analysis||Sarilumab 150 mg q2w vs Placebo q2w|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||3.848|-0.818|0.2026
72379565|NCT01709578|144267206|SUPERIORITY_OR_OTHER||LS Mean Difference|2.013||||0.0854|TWO_SIDED|95.0|-0.282|4.309||Threshold for significance at 0.025 level|Mixed Models Analysis||Sarilumab 200 mg q2w vs Placebo q2w|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||4.309|-0.282|0.0854
72379566|NCT00902161|144267259|SUPERIORITY_OR_OTHER||Least Squared Mean Treatment Difference|32.0||||0.005|TWO_SIDED|95.0|15.0|49.0||There was only 1 primary hypothesis, so no multiplicity adjustment was required.|A linear mixed effect (LME) model|||The p-value is for testing the null hypothesis that the difference on Rt(65) between the \[MK-0893 1g + Propranolol\] vs. \[PBO + Propranolol\] \>=60 min. If p-value \< 0.05, then the null hypothesis is rejected at the significance level of 0.05, thus supporting the primary hypothesis that the treatment difference is less than 60 minutes.||49|15|0.005
72379567|NCT00988325|144267275|SUPERIORITY_OR_OTHER||Median time to cessation of viral sheddi|119.0|||=|0.166|TWO_SIDED|95.0|113.0|230.0||p-value is for the comparison of the age cohorts (treatment groups)|Wilcoxon (Mann-Whitney)|Wilcoxon Test was used for testing homogeneity of survival curves|Median time was estimated from the Kaplan-Meier curve (unstratified)|||230|113|=0.166
72379568|NCT00988325|144267277|SUPERIORITY_OR_OTHER||Time to Resolution of Fever in Patients|14.5|||=|0.059|TWO_SIDED|95.0|12.0|20.0||The p-value is for the comparison of the age cohorts (not including Total)|Wilcoxon (Mann-Whitney)||Median time was estimated from the Kaplan-Meier curve (unstratified)|||20|12|=0.059
72379569|NCT01314911|144267293|SUPERIORITY||Mean Difference (Final Values)|-12.2|STANDARD_ERROR_OF_MEAN|4.6||0.0097|TWO_SIDED|95.0|-21.4|-3.0||P-value was not adjusted for multiple interim analyses.|Z-test, 2-sided|Comparison of randomized arms was based on the normal approximation to the binomial distribution.|The difference in percents was calculated as the percent detectable in the Oseltamivir arm minus the percent detectable in the Placebo arm.|Assuming that pooled percentage of participants with virus detectable by PCR at Day 3 is 50%, assuming that the Oseltamivir arm was better than the placebo arm and that the detectable rate in the Oseltamivir arm was 42.5% compared to 57.5% in the placebo arm (a 15% reduction), and assuming 10% subjects with missing qPCR at Day 3, in a two-sided, two-sample 0.05-level t- test with 546 participants combined across both arms, there was 90% power.||-3.0|-21.4|0.0097
72379570|NCT01314911|144267296|SUPERIORITY|||||||0.0243||||||P-value was not adjusted for multiple interim analyses.|Wilcoxon (Mann-Whitney)|||||||0.0243
72379571|NCT01314911|144267297|SUPERIORITY|||||||0.41||||||P-value was not adjusted for multiple interim analyses.|Log Rank|||||||0.41
72379572|NCT01314911|144267298|SUPERIORITY|||||||0.88||||||P-value was not adjusted for multiple interim analyses.|Log Rank|||||||0.88
72379573|NCT01314911|144267299|SUPERIORITY|||||||0.7461||||||P-value was not adjusted for multiple interim analyses.|Log Rank|||||||0.7461
72379574|NCT01314911|144267300|SUPERIORITY|||||||0.1501||||||P-value was not adjusted for multiple interim analyses.|Log Rank|||||||0.1501
72379575|NCT01314911|144267301|SUPERIORITY|||||||0.3025||||||P-value was not adjusted for multiple interim analyses.|Log Rank|||||||0.3025
72379576|NCT01314911|144267302|SUPERIORITY|||||||0.5466||||||P-value was not adjusted for multiple interim analyses.|Log Rank|||||||0.5466
72379577|NCT01314911|144267304|SUPERIORITY||Mean Difference (Final Values)|0.7||||0.5311|TWO_SIDED|95.0|-1.4|3.0||P-value was not adjusted for multiple interim analyses.|two-sample binomial exact test|The two-sample binomial exact test was performed in PROC STATXACT.|The difference in percents was calculated as the percent in the Oseltamivir arm minus the percent in the placebo arm.|||3.0|-1.4|0.5311
72379578|NCT01314911|144267305|SUPERIORITY||Mean Difference (Final Values)|0.4||||0.8498|TWO_SIDED|95.0|-3.8|4.7||P-value was not adjusted for multiple interim analyses.|Z test||The difference in percents was calculated as the percent in the Oseltamivir arm minus the percent in the placebo arm.|This test compared the difference in percentages of participants with at least one complication between two randomized arms.||4.7|-3.8|0.8498
72379579|NCT01314911|144267307|SUPERIORITY||Mean Difference (Final Values)|-13.6||||0.0021|TWO_SIDED|95.0|-22.2|-5.1||P-value was not adjusted for multiple interim analyses.|Z test||||The difference in percents was calculated as the percent with detectable in the Oseltamivir arm minus the percent with detectable in the placebo arm.|-5.1|-22.2|0.0021
72379580|NCT01314911|144267310|SUPERIORITY|||||||0.022||||||P-value was not adjusted for multiple interim analyses.|Wilcoxon (Mann-Whitney)|||||||0.022
72379581|NCT00403403|144267363|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.528||||0.0097||95.0|0.323|0.862|||Log Rank||HR estimated from a stratified Cox regression model, stratified for ECOG performance (0-1 vs. 2) and chemotherapy type (cisplatin vs. carboplatin)|||0.862|0.323|0.0097
72379582|NCT00403403|144267364|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.16||||0.6054|TWO_SIDED|95.0|0.66|2.039|||Log Rank||HR estimated from a stratified Cox regression model, stratified for ECOG performance (0-1 vs. 2) and chemotherapy type (cisplatin vs. carboplatin)|||2.039|0.660|0.6054
72379583|NCT00403403|144267365|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.7||||0.3269||95.0|-9.6|29.0|||Chi-squared|||||29.0|-9.6|0.3269
72379584|NCT00403403|144267367|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.305||||0.0011|TWO_SIDED|95.0|0.144|0.644|||Log Rank||HR estimated from a stratified Cox regression model, stratified for ECOG performance (0-1 vs. 2) and chemotherapy type (cisplatin vs. carboplatin)|||0.644|0.144|0.0011
72379585|NCT02284178|144267423|SUPERIORITY|||||||0.432|||||||GEE analysis|||||||0.432
72379586|NCT02284178|144267424|SUPERIORITY|||||||0.684|||||||GEE|||||||0.684
72379587|NCT02284178|144267425|SUPERIORITY|||||||0.858|||||||Chi-squared|||||||0.858
72379588|NCT02284178|144267427|SUPERIORITY|||||||0.46|||||||GEE analysis|||||||0.460
72379589|NCT02284178|144267428|SUPERIORITY|||||||0.214|||||||t-test, 2 sided|||||||0.214
72379590|NCT02284178|144267429|SUPERIORITY|||||||0.155|||||||t-test, 2 sided|||||||0.155
72379591|NCT02284178|144267430|SUPERIORITY|||||||0.05|||||||t-test, 2 sided|||||||0.050
72379592|NCT04251156|144267460|SUPERIORITY|Responses were analysed using an analysis of covariance model with randomized treatment and type 2 diabetes status as factors and baseline body weight as covariate.|Treatment difference|-8.47|||<|0.0001|TWO_SIDED|95.0|-10.17|-6.76|||ANCOVA|||Treatment policy estimand||-6.76|-10.17|<0.0001
72379593|NCT04251156|144267461|SUPERIORITY|Responses were analysed using a binary logistic regression model with randomized treatment and type 2 diabetes status as factors and baseline body weight as covariate.|Odds Ratio (OR)|13.07|||<|0.0001|TWO_SIDED|95.0|7.4|23.1|||Regression, Logistic|||Treatment policy estimand||23.10|7.40|<0.0001
72379594|NCT01041495|144267503|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.869||||0.869|TWO_SIDED|95.0||||P values below 0.05 were considered statistically significant|t-test, 2 sided|||||||.869
72379595|NCT01041495|144267504|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.0||||0.486|TWO_SIDED||||||t-test, 2 sided|||Visual Analogue Pain Scale (VAPS). The final visit VAPS at 8th week will be compared against baseline VAPS scores for both treatment groups||||.486
72379596|NCT01041495|144267504|SUPERIORITY||Mean Difference (Final Values)|1.0||||0.486|TWO_SIDED||||||t-test, 1 sided|||||||.486
72379597|NCT01041495|144267505|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|17.0||||0.869|TWO_SIDED||||||t-test, 2 sided||As above- this was the difference between the groups on mean avg, it was used here|||||.869
72379598|NCT01041495|144267505|SUPERIORITY||Mean Difference (Final Values)|17.0||||0.275|TWO_SIDED||||||t-test, 1 sided|||||||.275
72379599|NCT02882074|144267506|SUPERIORITY||Mean Difference (Final Values)|0.27||||0.158|TWO_SIDED|95.0|-0.11|0.64|||Regression, Linear|||||0.64|-0.11|0.158
72379600|NCT02882074|144267507|SUPERIORITY||Ratio of geometric means|0.86||||0.388|TWO_SIDED|97.5|0.57|1.28||The significance criterion is p-value \< 0.025 (i.e. 0.05/2), corrected for multiple comparisons.|Mixed Models Analysis||Syndecan values were all log-transformed to meet the linearity requirement. Thus the treatment effect was presented as the ratio of geometric means.|||1.28|0.57|0.388
72379601|NCT02882074|144267508|SUPERIORITY||Ratio of geometric means|1.19||||0.257|TWO_SIDED|97.5|0.84|1.68||The significance criterion is p-value \< 0.025 (i.e. 0.05/2), corrected for multiple comparisons.|Mixed Models Analysis||Endocan values were all log-transformed to meet the linearity requirement. Thus the treatment effect was presented as the ratio of geometric means.|||1.68|0.84|0.257
72379602|NCT02882074|144267509|SUPERIORITY||Mean Difference (Final Values)|0.62||||0.003|TWO_SIDED|95.0|0.23|1.01|||Regression, Linear|||||1.01|0.23|0.003
72379603|NCT05867342|144267517|OTHER|||||||0.77||||||A p-value of \< 0.05 would be considered statistically significant.|t-test, 2 sided|||||||0.77
72379604|NCT05867342|144267518|OTHER|||||||0.002||||||A p-value of \< 0.05 would be considered statistically significant.|t-test, 2 sided|||||||0.002
72379605|NCT05867342|144267519|OTHER|||||||0.126||||||A p-value of \< 0.05 would be considered statistically significant.|t-test, 2 sided|||||||0.126
72379606|NCT05867342|144267521|OTHER|||||||0.213||||||A p-value of \< 0.05 would be considered statistically significant.|t-test, 2 sided|||||||0.213
72379607|NCT05867342|144267522|OTHER|||||||0.418||||||A p-value of \< 0.05 would be considered statistically significant.|t-test, 2 sided|||||||0.418
72379608|NCT05867342|144267523|OTHER|||||||0.756||||||A p-value of \< 0.05 would be considered statistically significant.|t-test, 2 sided|||||||0.756
72379609|NCT02313454|144267559|SUPERIORITY||Mean Difference (Final Values)|-0.6|STANDARD_DEVIATION|0.8||0.008|TWO_SIDED|95.0|-1.0|-0.19|||Paired t-test||Intranasal Application relative to the Extranasal Application|||-0.19|-1.0|0.008
72379610|NCT02313454|144267560|SUPERIORITY||Mean Difference (Final Values)|-11.2|STANDARD_ERROR_OF_MEAN|15.7||0.004|TWO_SIDED|95.0|-19.0|-3.4|||Paired t-test||Intranasal application relative to Extranasal application|||-3.4|-19.0|0.004
72379611|NCT03170232|144267606|OTHER||Mean Difference (Final Values)|-67.2|STANDARD_ERROR_OF_MEAN|159.7||0.679|TWO_SIDED|95.0|-400.6|266.2|||Repeated measures random coefficient|||||266.2|-400.6|0.679
72379612|NCT01101191|144267637|NON_INFERIORITY_OR_EQUIVALENCE|A mixed-model analysis of variance was used to compare (test vs reference) and the 90% confidence intervals were estimated for the ratios (test/reference)|Geometric Test/Ref Ratio x 100|103.0|||||TWO_SIDED|90.0|98.67|106.66|||ANOVA||Bioequivalence is established when 90% Confidence Interval falls within 80%-125%.|||106.66|98.67|
72379613|NCT01101191|144267638|NON_INFERIORITY_OR_EQUIVALENCE|A mixed-model analysis of variance was used to compare (test vs reference) and the 90% confidence intervals were estimated for the ratios (test/reference)|Geometric Test/Ref Ratio x 100|97.0|||||TWO_SIDED|90.0|94.2|99.81|||ANOVA||Bioequivalence is established when 90% Confidence Interval falls within 80%-125%.|||99.81|94.20|
72379614|NCT01101191|144267639|NON_INFERIORITY_OR_EQUIVALENCE|A mixed-model analysis of variance was used to compare (test vs reference) and the 90% confidence intervals were estimated for the ratios (test/reference)|Geometric Test/Ref Ratio x 100|97.1|||||TWO_SIDED|90.0|94.41|99.94|||ANOVA||Bioequivalence is established when 90% Confidence Interval falls within 80%-125%.|||99.94|94.41|
72379615|NCT00718237|144267643|SUPERIORITY_OR_OTHER||Vaccine Efficacy (1-Relative Risk [RR])|80.2|||<|0.001|TWO_SIDED|95.0|47.4|94.1||Hypothesis: Efficacy \>0%. Based on p\< 1/(1+k); p = proportion of participants with outcome in vaccine group relative to total number of subjects with outcome; k = ratio of follow-up time; placebo/vaccine. Based on conditional binomial approach.|Exact Conditional Test|Exact Conditional Test based on Binomial Distribution|Efficacy = 1-RR, expressed as a percentage; the RR is the incidence in the vaccine group / the incidence in the placebo group, adjusted for the ratio of the follow-up period in each group.|||94.1|47.4|<0.001
72379616|NCT00718237|144267644|SUPERIORITY_OR_OTHER||Vaccine Efficacy (1-Relative Risk [RR])|74.5|||<|0.001|TWO_SIDED|95.0|39.9|90.6||Hypothesis: Efficacy \>0%. Based on p\< 1/(1+k); p = proportion of participants with outcome in vaccine group relative to total number of subjects with outcome; k = ratio of follow-up time; placebo/vaccine. Based on conditional binomial approach.|Exact Conditional Test|Exact Conditional Test based on Binomial Distribution|Efficacy = 1-RR, expressed as a percentage; the RR is the incidence in the vaccine group / the incidence in the placebo group, adjusted for the ratio of the follow-up period in each group.|||90.6|39.9|<0.001
72379617|NCT00718237|144267645|SUPERIORITY_OR_OTHER||Vaccine Efficacy (1-Relative Risk [RR])|100.0|||<|0.001|TWO_SIDED|95.0|55.4|100.0||Hypothesis: Efficacy \>0%. Based on p\< 1/(1+k); p = proportion of participants with outcome in vaccine group relative to total number of subjects with outcome; k = ratio of follow-up time; placebo/vaccine. Based on conditional binomial approach.|Exact Conditional Test|Exact Conditional Test based on Binomial Distribution|Efficacy = 1-RR, expressed as a percentage; the RR is the incidence in the vaccine group / the incidence in the placebo group, adjusted for the ratio of the follow-up period in each group.|||100.0|55.4|<0.001
72379618|NCT02925793|144267653|SUPERIORITY||Mean Difference|-2.9||||0.0106|TWO_SIDED||||||SAS Proc Mixed||For each subject, change in NRS score from baseline to week 8 was calculated as Week 8 NRS value minus Baseline NRS value. Mean change in NRS score from baseline to week 8 for each group was then calculated using a Generalized Linear Mixed Model.|Both 1% and 5% groups (statistical analysis 2) produced the same estimated value (-2.9)||||0.0106
72379619|NCT02925793|144267653|SUPERIORITY||Mean Difference|-2.9||||0.0483|TWO_SIDED||||||SAS Proc Mixed||For each subject, change in NRS score from baseline to week 8 was calculated as Week 8 NRS value minus Baseline NRS value. Mean change in NRS score from baseline to week 8 for each group was then calculated using a Generalized Linear Mixed Model.|Both 1%(statistical analysis 1) and 5% groups produced the same estimated value (-2.9)||||0.0483
72379620|NCT00829985|144267703|SUPERIORITY_OR_OTHER||Risk Ratio, log|1.92|||<|0.0001|TWO_SIDED|95.0|1.51|2.45|||Mixed Models Analysis||The estimated value and associated confidence interval represent the ratio of baseline-to-post-baseline change in the placebo group (denominator = 1.12) vs. the extract group (numerator = 2.16).|||2.45|1.51|<0.0001
72379621|NCT00829985|144267704|SUPERIORITY_OR_OTHER||Risk Ratio, log|1.13||||0.088|TWO_SIDED|95.0|0.98|1.32|||Mixed Models Analysis||The estimated value and associated confidence interval represent the ratio of baseline-to-post-baseline change in the placebo group (denominator = 0.93) vs. the extract group (numerator = 1.06).|||1.32|0.98|0.088
72379622|NCT00829985|144267705|SUPERIORITY_OR_OTHER||Treatment Effect|0.37||||0.37|TWO_SIDED|95.0|-4.89|12.99|||Mixed Models Analysis||Estimated value and associated confidence interval represent the treatment effect: change in the extract group (4.7) minus change in the placebo group (0.7).|||12.99|-4.89|0.37
72379623|NCT00829985|144267706|SUPERIORITY_OR_OTHER||Treatment Effect|5.4||||0.09|TWO_SIDED|95.0|-0.77|11.51|||Mixed Models Analysis||Estimated value and associated confidence interval represent the treatment effect: change in the extract group (4.0) minus change in the placebo group (-1.3).|||11.51|-0.77|0.09
72379624|NCT03324581|144267714|SUPERIORITY||Difference|0.81|||=|0.7554|TWO_SIDED|95.0|-4.3|5.92||The change from baseline in CAARS-O:SV was analyzed using a Mixed-effect Model Repeated Measures (MMRM) methodology with the unstructured variance covariance matrix.|Mixed-effect Model Repeated Measures|It included fixed class-effect terms: treatment,trial site,visit week, interaction term: treatment by visit week, Baseline CAARS-O:SV as a covariate.||||5.92|-4.30|=0.7554
72379625|NCT03324581|144267714|SUPERIORITY||Difference|-6.61|||=|0.0101|TWO_SIDED|95.0|-11.6|-1.6||The change from baseline in CAARS-O:SV was analyzed using a MMRM methodology with the unstructured variance covariance matrix.|Mixed-effect Model Repeated Measures|It included fixed class-effect terms: treatment,trial site,visit week, interaction term: treatment by visit week, Baseline CAARS-O:SV as a covariate.||||-1.60|-11.6|=0.0101
72379626|NCT03324581|144267714|SUPERIORITY||Difference|-7.42|||=|0.0033|TWO_SIDED|95.0|-12.3|-2.5||The change from baseline in CAARS-O:SV was analyzed using a MMRM methodology with the unstructured variance covariance matrix.|Mixed-effect Model Repeated Measures|It included fixed class-effect terms: treatment,trial site,visit week, interaction term: treatment by visit week, Baseline CAARS-O:SV as a covariate.||||-2.50|-12.3|=0.0033
72379627|NCT04473482|144267750|SUPERIORITY|Generalized estimating equations with robust sandwich estimators used with Wald 95% confidence intervals and conversion to odds ratios|Odds Ratio (OR)|2.25|||||TWO_SIDED|95.0|||||||Generalized estimating equations with robust sandwich estimators used with Wald 95% confidence intervals and conversion to odds ratios||Generalized estimating equations with robust sandwich estimators used with Wald 95% confidence intervals|||
72379628|NCT04473482|144267751|SUPERIORITY||Odds Ratio (OR)|2.31|||||TWO_SIDED|95.0|||||||GEEs with robust sandwich estimators and Wald 95% CIs with conversion to Odds Ratios|||||
72379629|NCT01076075|144267766|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-0.68|||<|0.001|TWO_SIDED|95.0|-0.87|-0.5|||ANCOVA|Based on an ANCOVA model controlling for treatment, stratum (type of sulfonylurea) and baseline value.||Pairwise comparison - Sitagliptin vs. Placebo, using the difference in the Least Squares Means.||-0.50|-0.87|<0.001
72379630|NCT01076075|144267767|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-33.5|||<|0.001|TWO_SIDED|95.0|-45.3|-21.7|||ANCOVA|Based on an ANCOVA model controlling for treatment, stratum (type of sulfonylurea) and baseline value.||Pairwise comparison - Sitagliptin vs. Placebo, difference in the Least Squares Means.||-21.7|-45.3|<0.001
72379631|NCT01076075|144267768|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-18.6|||<|0.001|TWO_SIDED|95.0|-26.4|-10.7|||ANCOVA|Based on an ANCOVA model controlling for treatment, stratum (type of sulfonylurea) and baseline value.||Pairwise comparison - Sitagliptin vs. Placebo, using the difference in the Least Squares Means.||-10.7|-26.4|<0.001
72379632|NCT00076024|144267781|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.237||||0.156|TWO_SIDED|95.0|0.819|1.867|||Log Rank|One-sided log-rank test at alpha = 0.1 significance level was used.||P-value was calculated using one-sided Log rank test, stratified for estrogen receptor (ER) status (ER-positive or ER-negative/unknown), prior adjuvant chemotherapy (yes or no), and Eastern Cooperative Oncology Group (ECOG) performance status (less than or equal to \[=\<1\] or 2). The stratified Cox proportional hazards model was fitted, using the same stratification variables as above.||1.867|0.819|0.156
72379633|NCT00076024|144267782|SUPERIORITY_OR_OTHER||Difference in response rates|17.4||||0.038|TWO_SIDED|95.0|3.0|31.9|||Fisher Exact|||||31.9|3.0|0.038
72618534|NCT01026038|144768104|SUPERIORITY_OR_OTHER|||||||0.429||95.0|||||Fisher Exact|||Pain (Any): Fisher exact test, 2-sided was used. Pairwise comparison was made between 7vPnC/7vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.||||0.429
72618535|NCT01026038|144768104|SUPERIORITY_OR_OTHER|||||||0.314||95.0|||||Fisher Exact|||Pain (Any): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.||||0.314
72618536|NCT01026038|144768104|SUPERIORITY_OR_OTHER||||||>|0.99||95.0|||||Fisher Exact|||Pain (Mild): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/7vPnC/13vPnC.||||>0.990
72379634|NCT03981822|144267809|SUPERIORITY|||||||0.0048||||||P-value is based on the CMH test stratified by gender.|Cochran-Mantel-Haenszel|||Part B summary is pooled with its respective treatments from Part A.||||0.0048
72379635|NCT03981822|144267809|SUPERIORITY|||||||0.0075||||||P-value is based on the CMH test stratified by gender.|Cochran-Mantel-Haenszel|||Part B summary is pooled with its respective treatments from Part A.||||0.0075
72379636|NCT03981822|144267810|SUPERIORITY|||||||0.3642||||||P-value is based on the CMH test stratified by gender.|Cochran-Mantel-Haenszel|||Treatment Visit 2 - Part B summary is pooled with its respective treatments from Part A.||||0.3642
72379637|NCT03981822|144267810|SUPERIORITY|||||||0.0967||||||P-value is based on the CMH test stratified by gender.|Cochran-Mantel-Haenszel|||Treatment Visit 2: Part B summary is pooled with its respective treatments from Part A.||||0.0967
72379638|NCT03981822|144267810|SUPERIORITY|||||||0.0648||||||P-value is based on the CMH test stratified by gender.|Cochran-Mantel-Haenszel|||Treatment Visit 3: Part B summary is pooled with its respective treatments from Part A.||||0.0648
72379639|NCT03981822|144267810|SUPERIORITY|||||||0.1357||||||P-value is based on the CMH test stratified by gender.|Cochran-Mantel-Haenszel|||Treatment Visit 3: Part B summary is pooled with its respective treatments from Part A.||||0.1357
72379640|NCT03981822|144267810|SUPERIORITY|||||||0.019||||||P-value is based on the CMH test stratified by gender. Part B summary is pooled with its respective treatments from|Cochran-Mantel-Haenszel|||Treatment Visit 4 Part B summary is pooled with its respective treatments from Part A.||||0.0190
72379641|NCT03981822|144267810|SUPERIORITY|||||||0.0184||||||P-value is based on the CMH test stratified by gender.|Cochran-Mantel-Haenszel|||Treatment Visit 4 Part B summary is pooled with its respective treatments from Part A.||||0.0184
72379642|NCT03981822|144267810|SUPERIORITY|||||||0.0048||||||P-value is based on the CMH test stratified by gender.|Cochran-Mantel-Haenszel|||Study Day 84 EOT Visit - Part B summary is pooled with its respective treatments from Part A.||||0.0048
72379643|NCT03981822|144267810|SUPERIORITY|||||||0.0075||||||P-value is based on the CMH test stratified by gender.|Cochran-Mantel-Haenszel|||Study Day 84 EOT Visit - Part B summary is pooled with its respective treatments from Part A.||||0.0075
72379644|NCT03981822|144267810|SUPERIORITY|||||||0.0539||||||P-value is based on the CMH test stratified by gender.|Cochran-Mantel-Haenszel|||Follow-up Visit Day 112 - Part B summary is pooled with its respective treatments from Part A.||||0.0539
72379645|NCT03981822|144267810|SUPERIORITY|||||||0.1638||||||P-value is based on the CMH test stratified by gender.|Cochran-Mantel-Haenszel|||Follow-up Visit Day 112 - Part B summary is pooled with its respective treatments from Part A.||||0.1638
72379646|NCT03981822|144267810|SUPERIORITY|||||||0.4766||||||P-value is based on the CMH test stratified by gender.|Cochran-Mantel-Haenszel|||Follow-up Visit Day 147 EOS - Part B summary is pooled with its respective treatments from Part A.||||0.4766
72379647|NCT03981822|144267810|SUPERIORITY|||||||0.1588||||||P-value is based on the CMH test stratified by gender.|Cochran-Mantel-Haenszel|||Follow-up Visit Day 147 EOS - Part B summary is pooled with its respective treatments from Part A.||||0.1588
72379648|NCT03981822|144267811|SUPERIORITY|||||||0.3642||||||P-value is based on the CMH test stratified by gender. Part B summary is pooled with its respective treatments from Part A.|Cochran-Mantel-Haenszel|||Treatment Visit 2 Part B summary is pooled with its respective treatments from Part A.||||0.3642
72379649|NCT03981822|144267811|SUPERIORITY|||||||0.0356|||||||Cochran-Mantel-Haenszel|P-value is based on the CMH test stratified by gender.||Treatment Visit 3 Part B summary is pooled with its respective treatments from Part A.||||0.0356
72379650|NCT03981822|144267811|SUPERIORITY|||||||0.0118|||||||Cochran-Mantel-Haenszel|P-value is based on the CMH test stratified by gender||Treatment Visit 4 Part B summary is pooled with its respective treatments from Part A.||||0.0118
72379651|NCT03981822|144267811|SUPERIORITY|||||||0.0026||||||P-value is based on the CMH test stratified by gender.|Cochran-Mantel-Haenszel|||Study Day84 EOT Part B summary is pooled with its respective treatments from Part A.||||0.0026
72379652|NCT03981822|144267811|SUPERIORITY|||||||0.0174|||||||Cochran-Mantel-Haenszel|P-value is based on the CMH test stratified by gender.||Follow-up Visit Day 112 Part B summary is pooled with its respective treatments from Part A.||||0.0174
72379653|NCT03981822|144267811|SUPERIORITY|||||||0.1311|||||||Cochran-Mantel-Haenszel|P-value is based on the CMH test stratified by gender.||Follow-up Visit Day 147 EOS Part B summary is pooled with its respective treatments from Part A.||||0.1311
72379654|NCT03981822|144267811|SUPERIORITY|||||||0.0967|||||||Cochran-Mantel-Haenszel|P-value is based on the CMH test stratified by gender.||Treatment Visit 2 Part B summary is pooled with its respective treatments from Part A.||||0.0967
72379655|NCT03981822|144267811|SUPERIORITY|||||||0.1357|||||||Cochran-Mantel-Haenszel|P-value is based on the CMH test stratified by gender.||Treatment Visit 3 Part B summary is pooled with its respective treatments from Part A.||||0.1357
72379656|NCT03981822|144267811|SUPERIORITY|||||||0.0184|||||||Cochran-Mantel-Haenszel|P-value is based on the CMH test stratified by gender.||Treatment Visit 4 Part B summary is pooled with its respective treatments from Part A.||||0.0184
72379657|NCT03981822|144267811|SUPERIORITY|||||||0.0024|||||||Cochran-Mantel-Haenszel|P-value is based on the CMH test stratified by gender.||Study Day 84 EOT Visit Part B summary is pooled with its respective treatments from Part A.||||0.0024
72379658|NCT03981822|144267811|SUPERIORITY|||||||0.1034|||||||Cochran-Mantel-Haenszel|P-value is based on the CMH test stratified by gender.||Follow-up Visit Day 112 Part B summary is pooled with its respective treatments from Part A.||||0.1034
72379659|NCT03981822|144267811|SUPERIORITY|||||||0.1029|||||||Cochran-Mantel-Haenszel|P-value is based on the CMH test stratified by gender.||Follow-up Visit Day 147 EOS Part B summary is pooled with its respective treatments from Part A.||||0.1029
72379660|NCT03981822|144267812|SUPERIORITY|||||||0.0356|||||||Cochran-Mantel-Haenszel|P-value is based on the CMH test stratified by gender.||Treatment Visit 2: Part B summary is pooled with its respective treatments from Part A.||||0.0356
72379661|NCT03981822|144267812|SUPERIORITY|||||||0.1477|||||||Cochran-Mantel-Haenszel|P-value is based on the CMH test stratified by gender.||Treatment Visit 2: Part B summary is pooled with its respective treatments from Part A.||||0.1477
72379662|NCT03981822|144267812|SUPERIORITY|||||||0.0062|||||||Cochran-Mantel-Haenszel|P-value is based on the CMH test stratified by gender.||Treatment Visit 3: Part B summary is pooled with its respective treatments from Part A.||||0.0062
72379663|NCT03981822|144267812|SUPERIORITY|||||||0.0046|||||||Cochran-Mantel-Haenszel|P-value is based on the CMH test stratified by gender.||Treatment Visit 3: Part B summary is pooled with its respective treatments from Part A.||||0.0046
72379664|NCT03981822|144267812|SUPERIORITY|||||||0.0177|||||||Cochran-Mantel-Haenszel|P-value is based on the CMH test stratified by gender.||Treatment Visit 4: Part B summary is pooled with its respective treatments from Part A.||||0.0177
72379665|NCT03981822|144267812|SUPERIORITY|||||||0.0054|||||||Cochran-Mantel-Haenszel|P-value is based on the CMH test stratified by gender.||Treatment Visit 4: Part B summary is pooled with its respective treatments from Part A.||||0.0054
72379666|NCT03981822|144267812|SUPERIORITY|||||||0.0013|||||||Cochran-Mantel-Haenszel|P-value is based on the CMH test stratified by gender.||Study Day 84 (EOT) visit: Part B summary is pooled with its respective treatments from Part A.||||0.0013
72379667|NCT03981822|144267812|SUPERIORITY|||||||0.0034|||||||Cochran-Mantel-Haenszel|P-value is based on the CMH test stratified by gender.||Study Day 84 (EOT) Visit: Part B summary is pooled with its respective treatments from Part A.||||0.0034
72379668|NCT03981822|144267812|SUPERIORITY|||||||0.0156|||||||Cochran-Mantel-Haenszel|P-value is based on the CMH test stratified by gender.||Follow-up visit day 112: Part B summary is pooled with its respective treatments from Part A.||||0.0156
72379669|NCT03981822|144267812|SUPERIORITY|||||||0.0367|||||||Cochran-Mantel-Haenszel|P-value is based on the CMH test stratified by gender.||Follow-up visit day 112: Part B summary is pooled with its respective treatments from Part A.||||0.0367
72379670|NCT03981822|144267812|SUPERIORITY|||||||0.1746|||||||Cochran-Mantel-Haenszel|P-value is based on the CMH test stratified by gender.||Follow-up visit day 147 (EOS): Part B summary is pooled with its respective treatments from Part A.||||0.1746
72379671|NCT03981822|144267812|SUPERIORITY|||||||0.0123|||||||Cochran-Mantel-Haenszel|P-value is based on the CMH test stratified by gender.||Follow-up visit day 147 (EOS): Part B summary is pooled with its respective treatments from Part A.||||0.0123
72379672|NCT03981822|144267813|SUPERIORITY||LS mean difference|-3.96||||0.0021|TWO_SIDED|95.0|-5.41|-1.24||Analysis is based on MMRM model|Mixed Models Analysis|"MMRM model with gender, Tx, visit, Tx by visit interaction, and baseline wart count as factors.~An unstructured covariance model was used."||Treatment Visit 2: Part B summary is pooled with its respective treatments from Part A.||-1.24|-5.41|0.0021
72379673|NCT03981822|144267813|SUPERIORITY||LS mean difference|-4.72||||0.015|TWO_SIDED|95.0|-5.95|-0.66|||Mixed Models Analysis|"MMRM model with gender, Tx, visit, treatment by visit interaction, and baseline wart count as factors.~An unstructured covariance model was used."||Treatment Visit 3: Part B summary is pooled with its respective treatments from Part A.||-0.66|-5.95|0.0150
72379674|NCT03981822|144267813|SUPERIORITY||LS mean difference|-5.31||||0.0011|TWO_SIDED|95.0|-6.54|-1.69||Analysis is based on MMRM model|Mixed Models Analysis|"MMRM model with gender, Tx, visit, treatment by visit interaction, and baseline wart count as factors.~An unstructured covariance model was used."||Treatment Visit 4: Part B summary is pooled with its respective treatments from Part A.||-1.69|-6.54|0.0011
72379675|NCT03981822|144267813|SUPERIORITY||LS mean difference|-6.5||||0.0007|TWO_SIDED|95.0|-8.25|-2.32||P-value is based on MMRM model|Mixed Models Analysis|"MMRM model with gender, Tx, visit, treatment by visit interaction, and baseline wart count as factors.~An unstructured covariance model was used."||Study Day 84 EOT Visit: Part B summary is pooled with its respective treatments from Part A.||-2.32|-8.25|0.0007
72379676|NCT03981822|144267813|SUPERIORITY||LS mean difference|-6.15||||0.0012|TWO_SIDED|95.0|-7.5|-1.91||P-value is based on MMRM model|Mixed Models Analysis|"MMRM model with gender, Tx, visit, treatment by visit interaction, and baseline wart count as factors.~An unstructured covariance model was used."||Follow-up day 112: Part B summary is pooled with its respective treatments from Part A.||-1.91|-7.50|0.0012
72379677|NCT03981822|144267813|SUPERIORITY||LS mean difference|-5.02||||0.0349|TWO_SIDED|95.0|-6.78|-0.26||P-value is based on MMRM model|Mixed Models Analysis|"MMRM model with gender, Tx, visit, treatment by visit interaction, and baseline wart count as factors.~An unstructured covariance model was used."||Follow-up visit day 147 (EOS): Part B summary is pooled with its respective treatments from Part A.||-0.26|-6.78|0.0349
72379678|NCT03981822|144267813|SUPERIORITY||LS mean difference|-4.76|||<|0.0001|TWO_SIDED|95.0|-7.47|-2.85||P-value is based on MMRM mode|Mixed Models Analysis|"MMRM model with gender, Tx, visit, treatment by visit interaction, and baseline wart count as factors.~An unstructured covariance model was used."||Treatment visit 2: Part B summary is pooled with its respective treatments from Part A.||-2.85|-7.47|<0.0001
72379679|NCT03981822|144267813|SUPERIORITY||LS mean difference|-6.0||||0.0005|TWO_SIDED|95.0|-8.37|-2.43||Analysis is based on MMRM model|Mixed Models Analysis|"MMRM model with gender, Tx, visit, treatment by visit interaction, and baseline wart count as factors.~An unstructured covariance model was used."||Treatment Visit 3: Degrees of freedom associated with the error term were computed using Kenward-Rogers method.||-2.43|-8.37|0.0005
72379680|NCT03981822|144267813|SUPERIORITY||LS mean difference|-6.64|||<|0.0001|TWO_SIDED|95.0|-9.65|-4.12||Analysis based on MMRM model|Mixed Models Analysis|"MMRM model with gender, Tx, visit, treatment by visit interaction, and baseline wart count as factors.~An unstructured covariance model was used."||Treatment visit 4: Part B summary is pooled with its respective treatments from Part A.||-4.12|-9.65|<0.0001
72556334|NCT00862563|144643982|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||p\<0.01 is considered to be significant|Mixed Models Analysis|p value is for group x time interaction term for the comparison of data for the topiramate and placebo group.||Data were analyzed using two-way repeated measures mixed models analysis. It was hypothesized that COWAT-Letter Fluency scores would change towards a downward direction for the topiramate as compared to the placebo group resulting in a significant treatment x time interaction.||||<0.0001
72379681|NCT03981822|144267813|SUPERIORITY||LS mean difference|-6.49||||0.0004|TWO_SIDED|95.0|-9.67|-2.92||Analysis is based on MMRM model|Mixed Models Analysis|"MMRM model with gender, Tx, visit, treatment by visit interaction, and baseline wart count as factors.~An unstructured covariance model was used."||Study Day 84 (EOT): Part B summary is pooled with its respective treatments from Part A.||-2.92|-9.67|0.0004
72379682|NCT03981822|144267813|SUPERIORITY||LS mean difference|-6.96|||<|0.0001|TWO_SIDED|95.0|-9.89|-3.57||Analysis based on MMRM model|Mixed Models Analysis|"MMRM model with gender, Tx, visit, treatment by visit interaction, and baseline wart count as factors.~An unstructured covariance model was used."||Follow-up day 112: Part B summary is pooled with its respective treatments from Part A.||-3.57|-9.89|<0.0001
72379683|NCT03981822|144267813|SUPERIORITY||LS mean difference|-6.99||||0.0005|TWO_SIDED|95.0|-10.2|-2.94||Analysis based on MMRM model|Mixed Models Analysis|"MMRM model with gender, Tx, visit, treatment by visit interaction, and baseline wart count as factors.~An unstructured covariance model was used."||Follow up day 147 (EOS): Part B summary is pooled with its respective treatments from Part A.||-2.94|-10.20|0.0005
72379684|NCT03981822|144267814|SUPERIORITY||LS mean difference|-41.47|||<|0.0001|TWO_SIDED|95.0|-51.31|-20.87||P-value is based on MMRM model|Mixed Models Analysis|"MMRM model with gender, Tx, visit, treatment by visit interaction, and baseline wart count as factors.~An unstructured covariance model was used."||Treatment Visit 2: Part B summary is pooled with its respective treatments from Part A.||-20.87|-51.31|<0.0001
72379685|NCT03981822|144267814|SUPERIORITY||LS mean difference|-50.95||||0.0004|TWO_SIDED|95.0|-66.18|-19.56||P-value is based on MMRM model|Mixed Models Analysis|"MMRM model with gender, Tx, visit, treatment by visit interaction, and baseline wart count as factors.~An unstructured covariance model was used."||Treatment Visit 3: Part B summary is pooled with its respective treatments from Part A.||-19.56|-66.18|0.0004
72379686|NCT03981822|144267814|SUPERIORITY||LS mean difference|-66.21|||<|0.0001|TWO_SIDED|95.0|-88.15|-35.87||P-value is based on MMRM model|Mixed Models Analysis|"MMRM model with gender, Tx, visit, treatment by visit interaction, and baseline wart count as factors.~An unstructured covariance model was used."||Treatment Visit 4: Part B summary is pooled with its respective treatments from Part A.||-35.87|-88.15|<0.0001
72379687|NCT03981822|144267814|SUPERIORITY||LS mean difference|-79.37|||<|0.0001|TWO_SIDED|95.0|-111.44|-49.77||P-value is based on MMRM model|Mixed Models Analysis|"MMRM model with gender, Tx, visit, treatment by visit interaction, and baseline wart count as factors.~An unstructured covariance model was used."||Study Day 84 End of Treatment Visit: Part B summary is pooled with its respective treatments from Part A.||-49.77|-111.44|<0.0001
72379688|NCT03981822|144267814|SUPERIORITY||LS mean difference|-69.79||||0.0001|TWO_SIDED|95.0|-103.17|-35.25||P-value is based on MMRM model|Mixed Models Analysis|"MMRM model with gender, Tx, visit, treatment by visit interaction, and baseline wart count as factors.~An unstructured covariance model was used."||Follow up Day 112: Part B summary is pooled with its respective treatments from Part A.||-35.25|-103.17|0.0001
72379689|NCT03981822|144267814|SUPERIORITY||LS mean difference|-41.22||||0.1033|TWO_SIDED|95.0|-90.61|8.56||P-value is based on MMRM model|Mixed Models Analysis|"MMRM model with gender, Tx, visit, treatment by visit interaction, and baseline wart count as factors.~An unstructured covariance model was used."||Follow up Visit Day 147 End of Study: Part B summary is pooled with its respective treatments from Part A.||8.56|-90.61|0.1033
72379690|NCT03981822|144267814|SUPERIORITY||LS mean difference|-58.43|||<|0.0001|TWO_SIDED|95.0|-73.26|-39.39||P-value is based on MMRM model|Mixed Models Analysis|"MMRM model with gender, Tx, visit, treatment by visit interaction, and baseline wart count as factors.~An unstructured covariance model was used."||Treatment Visit 2: Part B summary is pooled with its respective treatments from Part A.||-39.39|-73.26|<0.0001
72379691|NCT03981822|144267814|SUPERIORITY||LS mean difference|-69.86|||<|0.0001|TWO_SIDED|95.0|-81.61|-28.8||P-value is based on MMRM model|Mixed Models Analysis|"MMRM model with gender, Tx, visit, treatment by visit interaction, and baseline wart count as factors.~An unstructured covariance model was used."||Treatment Visit 3: Part B summary is pooled with its respective treatments from Part A.||-28.80|-81.61|<0.0001
72379692|NCT03981822|144267814|SUPERIORITY||LS mean difference|-76.55|||<|0.0001|TWO_SIDED|95.0|-107.19|-45.61||P-value is based on MMRM model with gender, treatment, visit, treatment by visit interaction, and baseline wart count as factors.|Mixed Models Analysis|"MMRM model with gender, Tx, visit, treatment by visit interaction, and baseline wart count as factors.~An unstructured covariance model was used."||Treatment Visit 4: Part B summary is pooled with its respective treatments from Part A.||-45.61|-107.19|<0.0001
72379693|NCT03981822|144267814|SUPERIORITY||LS mean difference|-74.29||||0.0003|TWO_SIDED|95.0|-102.96|-31.55||P-value is based on MMRM model with gender, treatment, visit, treatment by visit interaction, and baseline wart count as factors.|Mixed Models Analysis|"MMRM model with gender, Tx, visit, treatment by visit interaction, and baseline wart count as factors.~An unstructured covariance model was used."||Study Day 84 End of Treatment Visit: Part B summary is pooled with its respective treatments from Part A.||-31.55|-102.96|0.0003
72379694|NCT03981822|144267814|SUPERIORITY||LS mean difference|-77.1||||0.0004|TWO_SIDED|95.0|-110.32|-32.78||P-value is based on MMRM model|Mixed Models Analysis|"MMRM model with gender, Tx, visit, treatment by visit interaction, and baseline wart count as factors.~An unstructured covariance model was used."||Follow-up Day 112: Part B summary is pooled with its respective treatments from Part A.||-32.78|-110.32|0.0004
72379695|NCT03981822|144267814|SUPERIORITY||LS mean difference|-77.52||||0.0178|TWO_SIDED|95.0|-120.82|-11.88||P-value is based on MMRM model|Mixed Models Analysis|"MMRM model with gender, Tx, visit, treatment by visit interaction, and baseline wart count as factors.~An unstructured covariance model was used."||Follow-up Visit Day 147 End of Study: Part B summary is pooled with its respective treatments from Part A.||-11.88|-120.82|0.0178
72379696|NCT03981822|144267815|SUPERIORITY|||||||0.0004||||||P-value is based on the CMH test stratified by gender.|Cochran-Mantel-Haenszel|||Treatment Visit 2: Part B summary is pooled with its respective treatments from Part A.||||0.0004
72379697|NCT03981822|144267815|SUPERIORITY|||||||0.0005||||||P-value is based on the CMH test stratified by gender.|Cochran-Mantel-Haenszel|||Treatment Visit 2: Part B summary is pooled with its respective treatments from Part A.||||0.0005
72379698|NCT03981822|144267815|SUPERIORITY|||||||0.0698||||||P-value is based on the CMH test stratified by gender.|Cochran-Mantel-Haenszel|||Treatment Visit 3: Part B summary is pooled with its respective treatments from Part A.||||0.0698
72379699|NCT03981822|144267815|SUPERIORITY|||||||0.01||||||P-value is based on the CMH test stratified by gender.|Cochran-Mantel-Haenszel|||Treatment Visit 3: Part B summary is pooled with its respective treatments from Part A.||||0.0100
72433622|NCT00991276|144380375|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.74|STANDARD_ERROR_OF_MEAN|0.24||0.0026|TWO_SIDED|95.0|0.26|1.21||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||1.21|0.26|0.0026
72379700|NCT03981822|144267815|SUPERIORITY|||||||0.0101||||||P-value is based on the CMH test stratified by gender.|Cochran-Mantel-Haenszel|||Treatment Visit 4: Part B summary is pooled with its respective treatments from Part A.||||0.0101
72379701|NCT03981822|144267815|SUPERIORITY|||||||0.0077||||||P-value is based on the CMH test stratified by gender.|Cochran-Mantel-Haenszel|||Treatment Visit 4: Part B summary is pooled with its respective treatments from Part A.||||0.0077
72379702|NCT03981822|144267815|SUPERIORITY|||||||0.064||||||P-value is based on the CMH test stratified by gender.|Cochran-Mantel-Haenszel|||Study Day 84 EOT Visit: Part B summary is pooled with its respective treatments from Part A.||||0.0640
72379703|NCT03981822|144267815|SUPERIORITY|||||||0.0045||||||P-value is based on the CMH test stratified by gender.|Cochran-Mantel-Haenszel|||Study Day 84 EOT: Part B summary is pooled with its respective treatments from Part A.||||0.0045
72379704|NCT03981822|144267815|SUPERIORITY|||||||0.284||||||P-value is based on the CMH test stratified by gender.|Cochran-Mantel-Haenszel|||Follow-up Visit Day 112: Part B summary is pooled with its respective treatments from Part A.||||0.2840
72379705|NCT03981822|144267815|SUPERIORITY|||||||0.0132||||||P-value is based on the CMH test stratified by gender.|Cochran-Mantel-Haenszel|||Follow-up Visit Day 112: Part B summary is pooled with its respective treatments from Part A.||||0.0132
72379706|NCT03981822|144267815|SUPERIORITY|||||||0.4668||||||P-value is based on the CMH test stratified by gender.|Cochran-Mantel-Haenszel|||Follow-up Visit Day 147 EOS: Part B summary is pooled with its respective treatments from Part A.||||0.4668
72556335|NCT00862563|144643982|SUPERIORITY_OR_OTHER|||||||0.3|TWO_SIDED|||||p\<0.01 is considered to be significant.|Mixed Models Analysis|p value is for interaction effect for the comparison of data for the levetiracetam and placebo groups.||Data were analyzed using two-way repeated measures mixed models analysis. It was hypothesized that COWAT-Letter Fluency scores would change towards a downward direction for the levetiracetam as compared to the placebo group resulting in a significant treatment x time interaction.||||0.30
72379707|NCT03981822|144267815|SUPERIORITY|||||||0.0064||||||P-value is based on the CMH test stratified by gender.|Cochran-Mantel-Haenszel|||Follow-up Visit Day 147 EOS: Part B summary is pooled with its respective treatments from Part A.||||0.0064
72379708|NCT03981822|144267816|SUPERIORITY|||||||0.0364|||||||Mantel Haenszel|Stratified by gender||Part B summary is pooled with its respective treatments from Part A.||||0.0364
72379709|NCT03981822|144267816|SUPERIORITY|||||||0.0215|||||||Cochran-Mantel-Haenszel|Stratified by gender||Part B summary is pooled with its respective treatments from Part A.||||0.0215
72379710|NCT03981822|144267817|SUPERIORITY||LS mean difference|-59.63||||0.1222|TWO_SIDED|95.0|-76.1|9.23||Analysis is based on MMRM model|Mixed Models Analysis|"MMRM model with gender, Tx, visit, treatment by visit interaction, and baseline wart area as factors.~An unstructured covariance model was used."||Study Day 84 (EOT: Part B summary is pooled with its respective treatments from Part A.||9.23|-76.10|0.1222
72379711|NCT03981822|144267817|SUPERIORITY||LS mean difference|-69.51||||0.0403|TWO_SIDED|95.0|-81.3|-1.9||Analysis based on MMRM model|Mixed Models Analysis|"MMRM model with gender, Tx, visit, treatment by visit interaction, and baseline wart area as factors.~An unstructured covariance model was used."||Study Day 112 (EOT: Part B summary is pooled with its respective treatments from Part A.||-1.90|-81.30|0.0403
72379712|NCT03981822|144267817|SUPERIORITY||LS mean difference|-58.88||||0.0863|TWO_SIDED|95.0|-77.79|5.33||Analysis is based on MMRM model|Mixed Models Analysis|"MMRM model with gender, Tx, visit, treatment by visit interaction, and baseline wart area as factors.~An unstructured covariance model was used."||Follow-up Visit Day 147 (EOS): Part B summary is pooled with its respective treatments from Part A.||5.33|-77.79|0.0863
72556336|NCT00862563|144643983|SUPERIORITY_OR_OTHER|||||||0.003|TWO_SIDED|||||p\<0.01 is considered to be significant.|Mixed Models Analysis|p value is for the group x time interaction effect for the paired comparison of COWAT-category data for the zonisamide and placebo groups.||Data were analyzed using two-way repeated measures mixed models analysis. It was hypothesized that COWAT-Category scores would change towards a downward direction for the zonisamide as compared to the placebo group resulting in significant treatment x time interaction.||||0.003
72379713|NCT03981822|144267817|SUPERIORITY||LS mean difference|-62.13||||0.0428|TWO_SIDED|95.0|-100.76|-1.73||Analysis is based on MMRM model|Mixed Models Analysis|"MMRM model with gender, Tx, visit, treatment by visit interaction, and baseline wart area as factors.~An unstructured covariance model was used."||Study Day 84 (EOT): Part B summary is pooled with its respective treatments from Part A.||-1.73|-100.76|0.0428
72379714|NCT03981822|144267817|SUPERIORITY||LS mean difference|-71.93||||0.0084|TWO_SIDED|95.0|-110.46|-17.0||Analysis is based on MMRM model|Mixed Models Analysis|"MMRM model with gender, Tx, visit, treatment by visit interaction, and baseline wart area as factors.~An unstructured covariance model was used."||Follow-up Day 112: Part B summary is pooled with its respective treatments from Part A.||-17.00|-110.46|0.0084
72379715|NCT03981822|144267817|SUPERIORITY||LS mean difference|-63.11||||0.0273|TWO_SIDED|95.0|-103.08|-6.35||Analysis is based on MMRM model|Mixed Models Analysis|"MMRM model with gender, Tx, visit, treatment by visit interaction, and baseline wart area as factors.~An unstructured covariance model was used."||Follow-up Visit Day 147 (EOS): Part B summary is pooled with its respective treatments from Part A.||-6.35|-103.08|0.0273
72618537|NCT01026038|144768104|SUPERIORITY_OR_OTHER|||||||0.552||95.0|||||Fisher Exact|||Pain (Mild): Fisher exact test, 2-sided was used. Pairwise comparison was made between 7vPnC/7vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.||||0.552
72379716|NCT03981822|144267818|SUPERIORITY|Analysis is based on MMRM model|LS mean difference|-44.65||||0.3083|TWO_SIDED|95.0|-69.96|22.47|||Mixed Models Analysis|"MMRM model with gender, Tx, visit, treatment by visit interaction, and baseline wart area as factors.~An unstructured covariance model was used."||Study Day 84 (EOT): Part B summary is pooled with its respective treatments from Part A.||22.47|-69.96|0.3083
72379717|NCT03981822|144267818|SUPERIORITY||LS mean difference|-55.8||||0.1686|TWO_SIDED|95.0|-86.93|15.56||Analysis is based on MMRM model|Mixed Models Analysis|"MMRM model with gender, Tx, visit, treatment by visit interaction, and baseline wart area as factors.~An unstructured covariance model was used."||Follow-up Day 112: Part B summary is pooled with its respective treatments from Part A.||15.56|-86.93|0.1686
72379718|NCT03981822|144267818|SUPERIORITY||LS mean difference|-38.06||||0.2384|TWO_SIDED|95.0|-87.04|22.1||Analysis is based on MMRM model|Mixed Models Analysis|"MMRM model with gender, Tx, visit, treatment by visit interaction, and baseline wart area as factors.~An unstructured covariance model was used."||Follow-up Visit Day 147 End of Study: Part B summary is pooled with its respective treatments from Part A.||22.10|-87.04|0.2384
72379719|NCT03981822|144267818|SUPERIORITY||LS mean difference|-61.96||||0.0603|TWO_SIDED|95.0|-103.37|2.27||Analysis is based on MMRM model|Mixed Models Analysis|"MMRM model with gender, Tx, visit, treatment by visit interaction, and baseline wart area as factors.~An unstructured covariance model was used."||Study Day 84 (EOT): Part B summary is pooled with its respective treatments from Part A.||2.27|-103.37|0.0603
72379720|NCT03981822|144267818|SUPERIORITY||LS mean difference|-74.87||||0.0109|TWO_SIDED|95.0|-138.71|-18.83||Analysis is based on MMRM model|Mixed Models Analysis|"MMRM model with gender, Tx, visit, treatment by visit interaction, and baseline wart area as factors.~An unstructured covariance model was used."||Follow-up Visit Day 112: Part B summary is pooled with its respective treatments from Part A.||-18.83|-138.71|0.0109
72379721|NCT03981822|144267818|SUPERIORITY||LS mean difference|-66.62||||0.0467|TWO_SIDED|95.0|-127.64|-0.99||Analysis is base on MMRM model|Mixed Models Analysis|"MMRM model with gender, Tx, visit, treatment by visit interaction, and baseline wart area as factors.~An unstructured covariance model was used."||Follow-up Visit Day 147 End of Study: Part B summary is pooled with its respective treatments from Part A.||-0.99|-127.64|0.0467
72379722|NCT06460493|144267819|OTHER|The proportion of subjects classified as responders at week 12, standard errors, and corresponding 95% CI was estimated by negative binomial regression with background therapy (LABA/LAMA or LABA/LAMA/ICS) included as a fixed effect, and with baseline CAT score included as a covariate. The scale parameter in the negative binomial model was held fixed by specifying a noscale option.|Negative binomial regression|67.0|||||TWO_SIDED|95.0|38.0|100.0|||||A two-sided unadjusted 95% confidence interval for the proportion was used to determine study success with the lower bound of the CI \> 0 indicating success.|||100.0|38.0|
72379723|NCT06460493|144267820|OTHER|The proportion of subjects classified as responders at week 6, standard errors, and corresponding 95% CI was estimated by negative binomial regression with background therapy (LABA/LAMA or LABA/LAMA/ICS) included as a fixed effect, and with baseline CAT score included as a covariate. The scale parameter in the negative binomial model was held fixed by specifying a noscale option.|Negative binomial regression|44.4|||||TWO_SIDED|95.0|22.0|89.5|||||A two-sided unadjusted 95% confidence interval for the proportion was used to determine study success with the lower bound of the CI \> 0 indicating success.|||89.5|22.0|
72379724|NCT03780400|144267846|OTHER|test for within group change from baseline to 4 month follow-up||||||0.5145|||||||t-test, 2 sided|||||||0.5145
72379725|NCT03780400|144267847|OTHER|test for within group change from baseline to 4 month follow-up||||||0.3683|||||||t-test, 2 sided|||||||0.3683
72379726|NCT03780400|144267848|OTHER|test for within group change from baseline to 4 month follow-up||||||0.9858|||||||t-test, 2 sided|||||||0.9858
72379727|NCT03780400|144267849|OTHER|test for within group change from baseline to 4 month follow-up|||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
72379728|NCT03780400|144267850|OTHER|test for within group change from baseline to 4 month follow-up|||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
72379729|NCT03577171|144267883|OTHER||LS Mean Difference|-1.154||||0.0077|TWO_SIDED|95.0|-1.986|-0.322|||Repeated measures analysis|||Least Squares (LS) Mean Difference ABI-H0731 + SOC ETV minus Placebo + SOC ETV at Week 12||-0.322|-1.986|0.0077
72379730|NCT03577171|144267883|OTHER||LS Mean Difference|-1.141||||0.0084|TWO_SIDED|95.0|-1.973|-0.309|||Repeated measures analysis|||Least Squares Mean Difference ABI-H0731 + SOC ETV minus Placebo + SOC ETV at Week 24||-0.309|-1.973|0.0084
72379731|NCT03190369|144267950|SUPERIORITY||LS Mean difference|0.125|STANDARD_ERROR_OF_MEAN|0.137||0.361|TWO_SIDED|95.0|-0.144|0.395||Threshold for significance at 0.05 level.|ANCOVA|Least-square (LS) means, standard errors (SE) were analyzed from repeated measures ANCOVA.||Least-square (LS) means, standard errors (SE) were analyzed from repeated measures analysis of covariance (ANCOVA). The model included treatment groups (Hylan G-F 20 and placebo), site, visit and visit by treatment interaction, as well as the baseline WOMAC A1 score as a covariate).||0.395|-0.144|0.3610
72379732|NCT04543409|144267984|SUPERIORITY||Odds Ratio (OR)|117.49|||<|0.0001|TWO_SIDED|95.0|38.17|361.64|||Cochran-Mantel-Haenszel||The OR estimate and p-value was obtained from the CMH test controlling for region (North America and Rest of the world), baseline steroid use, and presence of strictures at baseline. Odds ratio values \>1 favor Benra 30 mg treatment group.|Analysis completed at Week 24.||361.64|38.17|<0.0001
72379733|NCT04543409|144267985|SUPERIORITY|For any patients with intercurrent events, the DSQ scores after the occurrence of those events were imputed using return-to-baseline MI. Missing data not due to intercurrent events were imputed using MI (MAR). Analysis was repeated on 100 imputed datasets, and results were combined using Rubin's formula.|Difference in Least Squares Means|2.999||||0.177|TWO_SIDED|95.0|-1.36|7.35|||ANCOVA|Model: Change from baseline in DSQ = Treatment + baseline DSQ + Region + Baseline steroid use + Presence of strictures at baseline.||Analysis completed at Week 24.||7.35|-1.36|0.1770
72379734|NCT04543409|144267986|SUPERIORITY|For any patients with intercurrent events, the Peak Esophageal intraepithelial eosinophil (eos) counts after the occurrence of those events were imputed using return-to-baseline MI. Missing data not due to intercurrent events were imputed using MI (MAR).|Difference in Least Squares Means|-96.2|||<|0.0001|TWO_SIDED|95.0|-114.53|-77.85|||ANCOVA|Model: Percent change from baseline in Peak Esophageal intraepithelial eos counts = Treatment + baseline Peak Esophageal intraepithelial eos counts.||Analysis completed at Week 24.||-77.85|-114.53|<0.0001
72379735|NCT04543409|144267987|SUPERIORITY|For any patients with intercurrent events, the EoE-HSS total grade score after the occurrence of those events were imputed using return-to-baseline MI. Missing data not due to intercurrent events were imputed using MI (MAR).|Difference in Least Squares Means|-0.175|||<|0.0001|TWO_SIDED|95.0|-0.21|-0.14|||ANCOVA|Change from baseline in EoE-HSS TGS = Treatment + baseline EoE-HSS grade score + Region + Baseline steroid use + Presence of strictures at baseline||||-0.14|-0.21|<0.0001
72379736|NCT04543409|144267988|SUPERIORITY|For any patients with intercurrent events, the EoE-HSS total stage score after the occurrence of those events were imputed using return-to-baseline MI. Missing data not due to intercurrent events were imputed using MI (MAR).|Difference in Least Squares Means|-0.122|||<|0.0001|TWO_SIDED|95.0|-0.16|-0.09|||ANCOVA|Change from baseline in EoE-HSS TSS = Treatment + baseline EoE-HSS stage score + Region + Baseline steroid use + Presence of strictures at baseline||||-0.09|-0.16|<0.0001
72379737|NCT04543409|144267989|SUPERIORITY|For any patients with intercurrent events, the centrally-read EREFS total score after the occurrence of those events were imputed using return-to-baseline MI. Missing data not due to intercurrent events were imputed using MI (MAR).|Difference in Least Squares Means|-0.1||||0.7322|TWO_SIDED|95.0|-0.52|0.32|||ANCOVA|Model: Change from baseline in EREFS TS = Treatment + baseline EREFS TS + Region + Baseline steroid use + Presence of strictures at baseline||Analysis completed at Week 24.||0.32|-0.52|0.7322
72379738|NCT04543409|144267990|SUPERIORITY||Odds Ratio (OR)|15.86|||<|0.0001|TWO_SIDED|95.0|5.79|43.47|||Cochran-Mantel-Haenszel||Controlling for region (North America and Rest of the world), baseline steroid use, and presence of strictures at baseline. OR values \>1 would favor Benra 30 mg treatment group.|||43.47|5.79|<0.0001
72556337|NCT00862563|144643983|SUPERIORITY_OR_OTHER|||||||0.01|TWO_SIDED|||||p\< 0.01 is considered to be significant.|Mixed Models Analysis|The p value shown is for the group x time interaction effect for the comparison of data from the topiramate and the placebo groups.||Data were analyzed using two-way repeated measures mixed models analysis. It was hypothesized that COWAT-Category scores would change towards a downward direction for the topiramate as compared to the placebo group resulting in significant treatment x time interaction||||0.01
72379739|NCT04543409|144267994|SUPERIORITY|For any patients with intercurrent events, the EoE-3D scores after the occurrence of those events were imputed using return-to-baseline MI. Missing data not due to intercurrent events were imputed using MI (MAR).|Difference in Least Squares Means|-0.04||||0.8656|TWO_SIDED|95.0|-0.5|0.42|||ANCOVA|Model: Change from baseline item score = Treatment + baseline item score + Region + Baseline steroid use + Presence of strictures at baseline.||Dysphagia-related pain.||0.42|-0.50|0.8656
72379740|NCT04543409|144267994|SUPERIORITY|For any patients with intercurrent events, the EoE-3D scores after the occurrence of those events were imputed using return-to-baseline MI. Missing data not due to intercurrent events were imputed using MI (MAR).|Difference in Least Squares Means|-0.181||||0.3926|TWO_SIDED|95.0|-0.6|0.23|||ANCOVA|Model: Change from baseline item score = Treatment + baseline item score + Region + Baseline steroid use + Presence of strictures at baseline.||Dysphagia-related discomfort.||0.23|-0.60|0.3926
72379741|NCT04543409|144267994|SUPERIORITY|For any patients with intercurrent events, the EoE-3D scores after the occurrence of those events were imputed using return-to-baseline MI. Missing data not due to intercurrent events were imputed using MI (MAR).|Difference in Least Squares Means|-0.344||||0.0867|TWO_SIDED|95.0|-0.74|0.05|||ANCOVA|Model: Change from baseline item score = Treatment + baseline item score + Region + Baseline steroid use + Presence of strictures at baseline||Overall episode severity.||0.05|-0.74|0.0867
72379742|NCT04543409|144267996|SUPERIORITY|For any patients with intercurrent events, the EoE-3D scores after the occurrence of those events were imputed using return-to-baseline MI. Missing data not due to intercurrent events were imputed using MI (MAR).|Difference in Least Squares Means|0.267||||0.2248|TWO_SIDED|95.0|-0.16|0.7|||ANCOVA|Model: Change from baseline item score = Treatment + baseline item score + Region + Baseline steroid use + Presence of strictures at baseline.||Abdominal pain severity||0.70|-0.16|0.2248
72379743|NCT04543409|144267996|SUPERIORITY|For any patients with intercurrent events, the EoE-3D scores after the occurrence of those events were imputed using return-to-baseline MI. Missing data not due to intercurrent events were imputed using MI (MAR).|Difference in Least Squares Means|0.296||||0.1575|TWO_SIDED|95.0|-0.11|0.71|||ANCOVA|Model: Change from baseline item score = Treatment + baseline item score + Region + Baseline steroid use + Presence of strictures at baseline||Nausea severity.||0.71|-0.11|0.1575
72379744|NCT04543409|144267999|SUPERIORITY|For any patients with intercurrent events, the EoE-QoL-A scores after the occurrence of those events were imputed using return-to-baseline MI. Missing data not due to intercurrent events were imputed using MI (MAR).|Difference in Least Squares Means|0.202||||0.8239|TWO_SIDED|95.0|-1.57|1.98|||ANCOVA|Model: Change from baseline item score = Treatment + baseline item score + Region + Baseline steroid use + Presence of strictures at baseline.||Eating/Diet Impact||1.98|-1.57|0.8239
72379745|NCT04543409|144267999|SUPERIORITY|For any patients with intercurrent events, the EoE-QoL-A scores after the occurrence of those events were imputed using return-to-baseline MI. Missing data not due to intercurrent events were imputed using MI (MAR).|Difference in Least Squares Means|0.147||||0.7623|TWO_SIDED|95.0|-0.8|1.1|||ANCOVA|Model: Change from baseline item score = Treatment + baseline item score + Region + Baseline steroid use + Presence of strictures at baseline||Social Impact||1.10|-0.80|0.7623
72379746|NCT04543409|144267999|SUPERIORITY|For any patients with intercurrent events, the EoE-QoL-A scores after the occurrence of those events were imputed using return-to-baseline MI. Missing data not due to intercurrent events were imputed using MI (MAR).|Difference of Least Squares Means|0.01||||0.9898|TWO_SIDED|95.0|-1.47|1.49|||ANCOVA|Model: Change from baseline item score = Treatment + baseline item score + Region + Baseline steroid use + Presence of strictures at baseline||Emotional Impact||1.49|-1.47|0.9898
72379747|NCT04543409|144267999|SUPERIORITY|For any patients with intercurrent events, the EoE-QoL-A scores after the occurrence of those events were imputed using return-to-baseline MI. Missing data not due to intercurrent events were imputed using MI (MAR).|Difference in Least Squares Means|0.386||||0.4603|TWO_SIDED|95.0|-0.64|1.41|||ANCOVA|Model: Change from baseline item score = Treatment + baseline item score + Region + Baseline steroid use + Presence of strictures at baseline||Disease Anxiety||1.41|-0.64|0.4603
72379748|NCT04543409|144267999|SUPERIORITY|For any patients with intercurrent events, the EoE-QoL-A scores after the occurrence of those events were imputed using return-to-baseline MI. Missing data not due to intercurrent events were imputed using MI (MAR).|Difference in Least Squares Means|-0.162||||0.6613|TWO_SIDED|95.0|-0.89|0.56|||ANCOVA|Model: Change from baseline item score = Treatment + baseline item score + Region + Baseline steroid use + Presence of strictures at baseline||Swallowing Anxiety||0.56|-0.89|0.6613
72379749|NCT04543409|144267999|SUPERIORITY|For any patients with intercurrent events, the EoE-QoL-A scores after the occurrence of those events were imputed using return-to-baseline MI. Missing data not due to intercurrent events were imputed using MI (MAR).|Difference in Least Squares Means|1.017||||0.6965|TWO_SIDED|95.0|-4.09|6.13|||ANCOVA|Model: Change from baseline item score = Treatment + baseline item score + Region + Baseline steroid use + Presence of strictures at baseline||Total Score||6.13|-4.09|0.6965
72379750|NCT04543409|144268001|SUPERIORITY|For any patients with intercurrent events, the SF-36 domain scores after the occurrence of those events were imputed using return-to-baseline MI. Missing data not due to intercurrent events were imputed using MI (MAR).|Difference in Least Squares Means|-0.3||||0.6852|TWO_SIDED|95.0|-1.93|1.27|||ANCOVA|Model: Change from baseline item score = Treatment + baseline item score + Region + Baseline steroid use + Presence of strictures at baseline.||Physical functioning (PF)||1.27|-1.93|0.6852
72556338|NCT00862563|144643983|SUPERIORITY_OR_OTHER|||||||0.36|TWO_SIDED|||||p\<0.01 is considered to be significant.|Mixed Models Analysis|The p value is for the group x time interaction effect for the comparison of the levetiracetam and placebo groups.||Data were analyzed using two-way repeated measures mixed models analysis. It was hypothesized that COWAT-Category scores would change towards a downward direction for the levetiracetam as compared to the placebo group resulting in significant treatment x time interaction||||0.36
72618538|NCT01026038|144768104|SUPERIORITY_OR_OTHER|||||||0.499||95.0|||||Fisher Exact|||Pain (Mild): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.||||0.499
72379751|NCT04543409|144268001|SUPERIORITY|For any patients with intercurrent events, the SF-36 domain scores after the occurrence of those events were imputed using return-to-baseline MI. Missing data not due to intercurrent events were imputed using MI (MAR).|Difference in Least Squares Means|-0.9||||0.2685|TWO_SIDED|95.0|-2.57|0.72|||ANCOVA|Model: Change from baseline item score = Treatment + baseline item score + Region + Baseline steroid use + Presence of strictures at baseline||Role limitations due to physical health (RP)||0.72|-2.57|0.2685
72379752|NCT04543409|144268001|SUPERIORITY|For any patients with intercurrent events, the SF-36 domain scores after the occurrence of those events were imputed using return-to-baseline MI. Missing data not due to intercurrent events were imputed using MI (MAR).|Difference in Least Squares Means|-0.8||||0.538|TWO_SIDED|95.0|-3.27|1.71|||ANCOVA|Model: Change from baseline item score = Treatment + baseline item score + Region + Baseline steroid use + Presence of strictures at baseline||Bodily pain (BP)||1.71|-3.27|0.5380
72379753|NCT04543409|144268001|SUPERIORITY|For any patients with intercurrent events, the SF-36 domain scores after the occurrence of those events were imputed using return-to-baseline MI. Missing data not due to intercurrent events were imputed using MI (MAR).|Difference in Least Squares Means|0.0||||0.9734|TWO_SIDED|95.0|-1.81|1.75|||ANCOVA|Model: Change from baseline item score = Treatment + baseline item score + Region + Baseline steroid use + Presence of strictures at baseline.||General health perceptions (GH)||1.75|-1.81|0.9734
72379754|NCT04543409|144268001|SUPERIORITY|For any patients with intercurrent events, the SF-36 domain scores after the occurrence of those events were imputed using return-to-baseline MI. Missing data not due to intercurrent events were imputed using MI (MAR).|Difference in Least Squares Means|0.0||||0.9653|TWO_SIDED|95.0|-2.09|2.19|||ANCOVA|Model: Change from baseline item score = Treatment + baseline item score + Region + Baseline steroid use + Presence of strictures at baseline||Vitality (VT)||2.19|-2.09|0.9653
72379755|NCT04543409|144268001|SUPERIORITY|For any patients with intercurrent events, the SF-36 domain scores after the occurrence of those events were imputed using return-to-baseline MI. Missing data not due to intercurrent events were imputed using MI (MAR).|Difference in Least Squares Means|-1.5||||0.2326|TWO_SIDED|95.0|-4.04|0.98|||ANCOVA|Model: Change from baseline item score = Treatment + baseline item score + Region + Baseline steroid use + Presence of strictures at baseline||Social functioning (SF)||0.98|-4.04|0.2326
72379756|NCT04543409|144268001|SUPERIORITY|For any patients with intercurrent events, the SF-36 domain scores after the occurrence of those events were imputed using return-to-baseline MI. Missing data not due to intercurrent events were imputed using MI (MAR).|Difference in Least Squares Means|-0.7||||0.6274|TWO_SIDED|95.0|-3.44|2.08|||ANCOVA|Model: Change from baseline item score = Treatment + baseline item score + Region + Baseline steroid use + Presence of strictures at baseline||Role limitations due to emotional problems (RE)||2.08|-3.44|0.6274
72379757|NCT04543409|144268001|SUPERIORITY|For any patients with intercurrent events, the SF-36 domain scores after the occurrence of those events were imputed using return-to-baseline MI. Missing data not due to intercurrent events were imputed using MI (MAR).|Difference in Least Squares Means|-0.9||||0.4599|TWO_SIDED|95.0|-3.14|1.42|||ANCOVA|Model: Change from baseline item score = Treatment + baseline item score + Region + Baseline steroid use + Presence of strictures at baseline||Mental health (MH)||1.42|-3.14|0.4599
72379758|NCT04543409|144268001|SUPERIORITY|For any patients with intercurrent events, the SF-36 domain scores after the occurrence of those events were imputed using return-to-baseline MI. Missing data not due to intercurrent events were imputed using MI (MAR).|Difference in Least Squares Means|-0.4||||0.6456|TWO_SIDED|95.0|-2.07|1.28|||ANCOVA|Model: Change from baseline item score = Treatment + baseline item score + Region + Baseline steroid use + Presence of strictures at baseline||Psychometrically-based physical summary score (PCS)||1.28|-2.07|0.6456
72379759|NCT04543409|144268001|SUPERIORITY|For any patients with intercurrent events, the SF-36 domain scores after the occurrence of those events were imputed using return-to-baseline MI. Missing data not due to intercurrent events were imputed using MI (MAR).|Difference in Least Squares Means|-0.6||||0.6206|TWO_SIDED|95.0|-3.08|1.84|||ANCOVA|Model: Change from baseline item score = Treatment + baseline item score + Region + Baseline steroid use + Presence of strictures at baseline.||Mental health component summary scores (MCS)||1.84|-3.08|0.6206
72379760|NCT03977454|144268013|SUPERIORITY||Mean Difference (Net)|1.2||||0.69|TWO_SIDED||||||t-test, 2 sided|||The primary endpoint was a comparison between groups at 24 hours.||||0.69
72379761|NCT03977454|144268014|SUPERIORITY||Mean Difference (Net)|0.1||||0.92|TWO_SIDED||||||t-test, 2 sided|||Scores were compared at 2 days post operation.||||0.92
72379762|NCT03977454|144268015|SUPERIORITY||Mean Difference (Net)|0.5||||0.91|TWO_SIDED||||||t-test, 2 sided|||||||0.91
72379763|NCT03977454|144268017|SUPERIORITY||Mean Difference (Net)|0.0||||0.85|TWO_SIDED||||||t-test, 2 sided|||Scores were compared at 2 weeks.||||0.85
72379764|NCT00518973|144268043|SUPERIORITY|||||||0.15||||||t = 2.8|t-test, 2 sided|Hours occupied by preoccupations.||||||.15
72379765|NCT00518973|144268043|SUPERIORITY|||||||0.4||||||t = .56|t-test, 2 sided|Hours of rituals||||||.40
72379766|NCT00518973|144268044|SUPERIORITY|||||||0.72||||||t = .13|t-test, 2 sided|||||||.72
72379767|NCT00518973|144268045|SUPERIORITY|||||||0.48||||||t = .52|t-test, 2 sided|Reporting for Trait||||||.48
72379768|NCT00518973|144268045|SUPERIORITY|||||||0.77||||||t = .09|t-test, 2 sided|Reporting for State||||||.77
72379769|NCT00518973|144268046|SUPERIORITY|||||||0.83||||||t = .05|t-test, 2 sided|||||||.83
72379770|NCT00518973|144268047|SUPERIORITY|||||||0.4||||||t = .78|t-test, 2 sided|Positive Scale||||||.40
72379771|NCT00518973|144268047|SUPERIORITY|||||||0.11||||||t=3.0|t-test, 2 sided|Negative Scale||||||.11
72379772|NCT00518973|144268047|SUPERIORITY|||||||0.9||||||t = .02|t-test, 2 sided|General Scale||||||.90
72379773|NCT02129777|144268048|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.008||||0.925|TWO_SIDED|95.0|-0.162|0.179|||Cochran-Mantel-Haenszel||Risk difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Cochran-Mantel-Haenszel (CMH) P-values are from a CMH Chi-Square test using a 2\*2 contingency table of treatment and responder status controlling for visit.||0.179|-0.162|0.925
72379774|NCT02129777|144268048|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.087||||0.162|TWO_SIDED|95.0|-0.202|0.028|||Cochran-Mantel-Haenszel||Risk difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|CMH P-values are from a CMH Chi-Square test using a 2\*2 contingency table of treatment and responder status controlling for visit.||0.028|-0.202|0.162
72379775|NCT02129777|144268048|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.034||||0.671|TWO_SIDED|95.0|-0.187|0.118|||Cochran-Mantel-Haenszel||Risk difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|CMH P-values are from a CMH Chi-Square test using a 2\*2 contingency table of treatment and responder status controlling for visit.||0.118|-0.187|0.671
72379776|NCT02129777|144268048|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.087||||0.182|TWO_SIDED|95.0|-0.202|0.028|||Cochran-Mantel-Haenszel||Risk difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|CMH P-values are from a CMH Chi-Square test using a 2\*2 contingency table of treatment and responder status controlling for visit.||0.028|-0.202|0.182
72379777|NCT02129777|144268050|SUPERIORITY_OR_OTHER||LS Mean Difference|1.4|STANDARD_ERROR_OF_MEAN|1.75||0.435|TWO_SIDED|95.0|-2.1|4.9|||MMRM||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Week 12: Post-baseline least squares means and p-values were from a MMRM model with main effect of study site, treatment, visit and interaction between visit and treatment as fixed effects, baseline value as a covariate with an unstructured covariance structure.||4.9|-2.1|0.435
72379778|NCT02129777|144268050|SUPERIORITY_OR_OTHER||LS Mean Difference|1.9|STANDARD_ERROR_OF_MEAN|1.74||0.279|TWO_SIDED|95.0|-1.6|5.4|||MMRM||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Week 12: Post-baseline least squares means and p-values were from a MMRM model with main effect of study site, treatment, visit and interaction between visit and treatment as fixed effects, baseline value as a covariate with an unstructured covariance structure.||5.4|-1.6|0.279
72379779|NCT02129777|144268050|SUPERIORITY_OR_OTHER||LS Mean Difference|3.0|STANDARD_ERROR_OF_MEAN|1.74||0.085|TWO_SIDED|95.0|-0.4|6.5|||MMRM||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Week 12: Post-baseline least squares means and p-values were from a MMRM model with main effect of study site, treatment, visit and interaction between visit and treatment as fixed effects, baseline value as a covariate with an unstructured covariance structure.||6.5|-0.4|0.085
72379780|NCT02129777|144268050|SUPERIORITY_OR_OTHER||LS Mean Difference|2.8|STANDARD_ERROR_OF_MEAN|1.76||0.11|TWO_SIDED|95.0|-0.7|6.3|||MMRM||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Week 12: Post-baseline least squares means and p-values were from a MMRM model with main effect of study site, treatment, visit and interaction between visit and treatment as fixed effects, baseline value as a covariate with an unstructured covariance structure.||6.3|-0.7|0.110
72379781|NCT02129777|144268051|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.027||||0.827|TWO_SIDED|95.0|-0.265|0.211|||Cochran-Mantel-Haenszel||Risk difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Week 12: CMH P-values are from a CMH Chi-Square test using a 2\*2 contingency table of treatment and responder status controlling for visit.||0.211|-0.265|0.827
72379782|NCT02129777|144268051|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.036||||0.768|TWO_SIDED|95.0|-0.269|0.198|||Cochran-Mantel-Haenszel||Risk difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Week 12: CMH P-values are from a CMH Chi-Square test using a 2\*2 contingency table of treatment and responder status controlling for visit.||0.198|-0.269|0.768
72379783|NCT02129777|144268051|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.112||||0.338|TWO_SIDED|95.0|-0.33|0.106|||Cochran-Mantel-Haenszel||Risk difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Week 12: CMH P-values are from a CMH Chi-Square test using a 2\*2 contingency table of treatment and responder status controlling for visit.||0.106|-0.330|0.338
72379784|NCT02129777|144268051|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.017||||0.89|TWO_SIDED|95.0|-0.261|0.226|||Cochran-Mantel-Haenszel||Risk difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Week 12: CMH P-values are from a CMH Chi-Square test using a 2\*2 contingency table of treatment and responder status controlling for visit.||0.226|-0.261|0.890
72379785|NCT02129777|144268052|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.048||||0.295|TWO_SIDED|95.0|-0.043|0.139|||Cochran-Mantel-Haenszel||Risk difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Week 12:CMH P-values are from a CMH Chi-Square test using a 2\*2 contingency table of treatment and responder status controlling for visit.||0.139|-0.043|0.295
72379786|NCT02129777|144268053|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.012||||0.906|TWO_SIDED|95.0|-0.191|0.216|||Cochran-Mantel-Haenszel||Risk difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Week 12: CMH P-values are from a CMH Chi-Square test using a 2\*2 contingency table of treatment and sPGA response category controlling for visit.||0.216|-0.191|0.906
72379787|NCT02129777|144268053|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.04||||0.677|TWO_SIDED|95.0|-0.222|0.143|||Cochran-Mantel-Haenszel||Risk difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Week 12: CMH P-values are from a CMH Chi-Square test using a 2\*2 contingency table of treatment and sPGA response category controlling for visit.||0.143|-0.222|0.677
72379788|NCT02129777|144268053|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.13||||0.107|TWO_SIDED|95.0|-0.268|0.007|||Cochran-Mantel-Haenszel||Risk difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Week 12: CMH P-values are from a CMH Chi-Square test using a 2\*2 contingency table of treatment and sPGA response category controlling for visit.||0.007|-0.268|0.107
72504916|NCT01272180|144540895|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The immune response of ABCWY+OMV group was considered to be non-inferior to that of ACWY group if the lower limit of the two-sided 95% confidence interval on the difference between groups in percentage of subjects with seroresponse is greater than -10% for each of A, C, W-135and Y serogroups, at 30 days after the last vaccination.|Group Difference % (ABCWY+OMV - ACWY)|16.0|||||TWO_SIDED|95.0|5.0|29.0||||||Non-inferiority of seroresponse against N.meningitidis serogroup A of two doses of MenABCWY combination vaccine to that of one dose of MenACWY vaccine.||29|5|
72379789|NCT02129777|144268053|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.08||||0.371|TWO_SIDED|95.0|-0.248|0.087|||Cochran-Mantel-Haenszel||Risk difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Week 12: CMH P-values are from a CMH Chi-Square test using a 2\*2 contingency table of treatment and sPGA response category controlling for visit.||0.087|-0.248|0.371
72379790|NCT02129777|144268054|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.095||||0.134|TWO_SIDED|95.0|-0.03|0.221|||Cochran-Mantel-Haenszel||Risk difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Week 12: CMH P-values are from a CMH Chi-Square test using a 2\*2 contingency table of treatment and sPGA response category controlling for visit.||0.221|-0.030|0.134
72379791|NCT02129777|144268055|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.18||0.258|TWO_SIDED|95.0|-0.6|0.2|||MMRM||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Week 12: Post-baseline least squares means and p-values were from a MMRM model with main effect of study site, treatment, visit and interaction between visit and treatment as fixed effects, baseline value as a covariate with an unstructured covariance structure. Baseline least squares means and p-values were obtained using an analysis of variance (ANOVA) model with terms for treatment and study site.||0.2|-0.6|0.258
72379792|NCT02129777|144268055|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.18||0.365|TWO_SIDED|95.0|-0.5|0.2|||MMRM||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Week 12: Post-baseline least squares means and p-values were from a MMRM model with main effect of study site, treatment, visit and interaction between visit and treatment as fixed effects, baseline value as a covariate with an unstructured covariance structure. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.||0.2|-0.5|0.365
72379793|NCT02129777|144268055|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.18||0.757|TWO_SIDED|95.0|-0.3|0.4|||MMRM||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Week 12: Post-baseline least squares means and p-values were from a MMRM model with main effect of study site, treatment, visit and interaction between visit and treatment as fixed effects, baseline value as a covariate with an unstructured covariance structure. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.||0.4|-0.3|0.757
72379794|NCT02129777|144268055|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.18||0.825|TWO_SIDED|95.0|-0.4|0.3|||MMRM||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Week 12: Post-baseline least squares means and p-values were from a MMRM model with main effect of study site, treatment, visit and interaction between visit and treatment as fixed effects, baseline value as a covariate with an unstructured covariance structure. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.||0.3|-0.4|0.825
72379795|NCT02129777|144268056|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|2.163||0.931|TWO_SIDED|95.0|-4.48|4.1|||MMRM||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Week 12: Post-baseline least squares means and p-values were from a MMRM model with main effect of study site, treatment, visit and interaction between visit and treatment as fixed effects, baseline value as a covariate with an unstructured covariance structure. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.||4.10|-4.48|0.931
72379796|NCT02129777|144268056|SUPERIORITY_OR_OTHER||LS Mean Difference|1.59|STANDARD_ERROR_OF_MEAN|2.143||0.459|TWO_SIDED|95.0|-2.65|5.84|||MMRM||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Week 12: Post-baseline least squares means and p-values were from a MMRM model with main effect of study site, treatment, visit and interaction between visit and treatment as fixed effects, baseline value as a covariate with an unstructured covariance structure. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.||5.84|-2.65|0.459
72379797|NCT02129777|144268056|SUPERIORITY_OR_OTHER||LS Mean Difference|3.65|STANDARD_ERROR_OF_MEAN|2.161||0.094|TWO_SIDED|95.0|-0.63|7.93|||MMRM||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Week 12: Post-baseline least squares means and p-values were from a MMRM model with main effect of study site, treatment, visit and interaction between visit and treatment as fixed effects, baseline value as a covariate with an unstructured covariance structure. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.||7.93|-0.63|0.094
72379798|NCT02129777|144268056|SUPERIORITY_OR_OTHER||LS Mean Difference|2.78|STANDARD_ERROR_OF_MEAN|2.173||0.203|TWO_SIDED|95.0|-1.52|7.09|||MMRM||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Week 12: Post-baseline least squares means and p-values were from a MMRM model with main effect of study site, treatment, visit and interaction between visit and treatment as fixed effects, baseline value as a covariate with an unstructured covariance structure. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.||7.09|-1.52|0.203
72379799|NCT02129777|144268057|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.53|STANDARD_ERROR_OF_MEAN|0.7||0.448|TWO_SIDED|95.0|-1.92|0.86|||MMRM||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Week 12: Post-baseline least squares means and p-values were from a MMRM model with main effect of study site, treatment, visit and interaction between visit and treatment as fixed effects, baseline value as a covariate with an unstructured covariance structure. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.||0.86|-1.92|0.448
72379800|NCT02129777|144268057|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.15|STANDARD_ERROR_OF_MEAN|0.692||0.099|TWO_SIDED|95.0|-2.53|0.22|||MMRM||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Week 12: Post-baseline least squares means and p-values were from a MMRM model with main effect of study site, treatment, visit and interaction between visit and treatment as fixed effects, baseline value as a covariate with an unstructured covariance structure. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.||0.22|-2.53|0.099
72433623|NCT00991276|144380376|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-6.1|STANDARD_ERROR_OF_MEAN|1.01|<|0.0001|TWO_SIDED|95.0|-8.1|-4.09||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||-4.09|-8.10|<0.0001
72505041|NCT01380093|144541430|SUPERIORITY_OR_OTHER||LS Mean Difference|-24.9|||<|0.0001|TWO_SIDED|95.0|-31.7|-18.1||p-value adjusted for multiple comparisons with Hochberg adjustment. At least one primary outcome for each of drug liking and high was required to be significant with adjusted p-value less than or equal to 0.05.|Mixed Models Analysis|||Least square (LS) mean and 95% confidence interval (CI) were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-18.1|-31.7|<0.0001
72379801|NCT02129777|144268057|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.59|STANDARD_ERROR_OF_MEAN|0.69||0.396|TWO_SIDED|95.0|-1.96|0.78|||MMRM||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Week 12: Post-baseline least squares means and p-values were from a MMRM model with main effect of study site, treatment, visit and interaction between visit and treatment as fixed effects, baseline value as a covariate with an unstructured covariance structure. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.||0.78|-1.96|0.396
72379802|NCT02129777|144268057|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.15|STANDARD_ERROR_OF_MEAN|0.697||0.102|TWO_SIDED|95.0|-2.54|0.23|||MMRM||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Week 12: Post-baseline least squares means and p-values were from a MMRM model with main effect of study site, treatment, visit and interaction between visit and treatment as fixed effects, baseline value as a covariate with an unstructured covariance structure. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.||0.23|-2.54|0.102
72379803|NCT02129777|144268058|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.04|STANDARD_ERROR_OF_MEAN|0.626||0.099|TWO_SIDED|95.0|-2.29|-0.2|||MMRM||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Week 12: Post-baseline least squares means and p-values were from a MMRM model with main effect of study site, treatment, visit and interaction between visit and treatment as fixed effects, baseline value as a covariate with an unstructured covariance structure. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.||-0.20|-2.29|0.099
72379804|NCT02129777|144268058|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.26|STANDARD_ERROR_OF_MEAN|0.619||0.045|TWO_SIDED|95.0|-2.49|-0.03|||MMRM||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Week 12: Post-baseline least squares means and p-values were from a MMRM model with main effect of study site, treatment, visit and interaction between visit and treatment as fixed effects, baseline value as a covariate with an unstructured covariance structure. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.||-0.03|-2.49|0.045
72379805|NCT02129777|144268058|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.98|STANDARD_ERROR_OF_MEAN|0.62||0.118|TWO_SIDED|95.0|-2.21|0.25|||MMRM||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Week 12: Post-baseline least squares means and p-values were from a MMRM model with main effect of study site, treatment, visit and interaction between visit and treatment as fixed effects, baseline value as a covariate with an unstructured covariance structure. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.||0.25|-2.21|0.118
72379806|NCT02129777|144268058|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.22|STANDARD_ERROR_OF_MEAN|0.616||0.05|TWO_SIDED|95.0|-2.44|0.0|||MMRM||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Week 12: Post-baseline least squares means and p-values were from a MMRM model with main effect of study site, treatment, visit and interaction between visit and treatment as fixed effects, baseline value as a covariate with an unstructured covariance structure. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.||0.00|-2.44|0.050
72379807|NCT02129777|144268059|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.63|STANDARD_ERROR_OF_MEAN|0.503||0.211|TWO_SIDED|95.0|-1.63|0.36|||MMRM||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Week 12: Post-baseline least squares means and p-values were from a MMRM model with main effect of study site, treatment, visit and interaction between visit and treatment as fixed effects, baseline value as a covariate with an unstructured covariance structure. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.||0.36|-1.63|0.211
72379808|NCT02129777|144268059|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.86|STANDARD_ERROR_OF_MEAN|0.497||0.087|TWO_SIDED|95.0|-1.85|0.13|||MMRM||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Week 12: Post-baseline least squares means and p-values were from a MMRM model with main effect of study site, treatment, visit and interaction between visit and treatment as fixed effects, baseline value as a covariate with an unstructured covariance structure. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.||0.13|-1.85|0.087
72379809|NCT02129777|144268059|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.27|STANDARD_ERROR_OF_MEAN|0.494||0.58|TWO_SIDED|95.0|-1.26|0.71|||MMRM||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Week 12: Post-baseline least squares means and p-values were from a MMRM model with main effect of study site, treatment, visit and interaction between visit and treatment as fixed effects, baseline value as a covariate with an unstructured covariance structure. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.||0.71|-1.26|0.580
72379810|NCT02129777|144268059|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.496||0.873|TWO_SIDED|95.0|-1.06|0.9|||MMRM||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Week 12: Post-baseline least squares means and p-values were from a MMRM model with main effect of study site, treatment, visit and interaction between visit and treatment as fixed effects, baseline value as a covariate with an unstructured covariance structure. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.||0.90|-1.06|0.873
72556339|NCT00862563|144643984|SUPERIORITY_OR_OTHER|||||||0.07|TWO_SIDED|||||p\<0.01 is considered to be significant|Mixed Models Analysis|p value is for the group x time interaction effect||Data were analyzed using two-way repeated measures mixed models analysis. It was hypothesized that Digit span scores would change towards a downward direction for the zonisamide as compared to the placebo group resulting in significant treatment x time interaction.||||0.07
72556340|NCT00862563|144643984|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||p\<0.01 is considered to be significant.|Mixed Models Analysis|p value shown is for the group X time interaction effect.||Data were analyzed using two-way repeated measures mixed models analysis. It was hypothesized that age adjusted Digit Span scores would change towards a downward direction for the topiramate as compared to the placebo group resulting in significant treatment x time interaction.||||<0.0001
72618539|NCT01026038|144768104|SUPERIORITY_OR_OTHER|||||||0.376||95.0|||||Fisher Exact|||Pain (Moderate): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/7vPnC/13vPnC.||||0.376
72556341|NCT00862563|144643984|SUPERIORITY_OR_OTHER|||||||0.95|TWO_SIDED|||||p\<0.01 is considered to be significant.|Mixed Models Analysis|p value shown is for the group x time interaction effect.||Data were analyzed using two-way repeated measures mixed models analysis. It was hypothesized that Digit span scores would change towards a downward direction for the levetiracetam as compared to the placebo group resulting in significant treatment x time interaction.||||0.95
72379811|NCT02129777|144268060|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.7|STANDARD_ERROR_OF_MEAN|6.7||0.803|TWO_SIDED|95.0|-15.2|11.8|||MMRM||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Week 12: Post-baseline least squares means and p-values were from a MMRM model with main effect of study site, treatment, visit and interaction between visit and treatment as fixed effects, baseline value as a covariate with an unstructured covariance structure. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.||11.8|-15.2|0.803
72379812|NCT02129777|144268060|SUPERIORITY_OR_OTHER||LS Mean Difference|7.9|STANDARD_ERROR_OF_MEAN|6.73||0.248|TWO_SIDED|95.0|-5.7|21.4|||MMRM||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Week 12: Post-baseline least squares means and p-values were from a MMRM model with main effect of study site, treatment, visit and interaction between visit and treatment as fixed effects, baseline value as a covariate with an unstructured covariance structure. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.||21.4|-5.7|0.248
72379813|NCT02129777|144268060|SUPERIORITY_OR_OTHER||LS Mean Difference|0.7|STANDARD_ERROR_OF_MEAN|6.67||0.914|TWO_SIDED|95.0|-12.7|14.2|||MMRM||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Week 12: Post-baseline least squares means and p-values were from a MMRM model with main effect of study site, treatment, visit and interaction between visit and treatment as fixed effects, baseline value as a covariate with an unstructured covariance structure. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.||14.2|-12.7|0.914
72379814|NCT02129777|144268060|SUPERIORITY_OR_OTHER||LS Mean Difference|4.3|STANDARD_ERROR_OF_MEAN|6.74||0.523|TWO_SIDED|95.0|-9.2|17.9|||MMRM||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Week 12: Post-baseline least squares means and p-values were from a MMRM model with main effect of study site, treatment, visit and interaction between visit and treatment as fixed effects, baseline value as a covariate with an unstructured covariance structure. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.||17.9|-9.2|0.523
72379815|NCT02129777|144268061|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|1.37||0.978|TWO_SIDED|95.0|-2.7|2.8|||ANCOVA||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Post-baseline least squares means and p-values were from an Analysis of covariance (ANCOVA) model with main effect of study site and treatment with baseline value as a covariate. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.||2.8|-2.7|0.978
72379816|NCT02129777|144268061|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|1.36||0.389|TWO_SIDED|95.0|-3.9|1.5|||ANCOVA||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Post-baseline least squares means and p-values were from an ANCOVA model with main effect of study site and treatment with baseline value as a covariate. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.||1.5|-3.9|0.389
72379817|NCT02129777|144268061|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.4|STANDARD_ERROR_OF_MEAN|1.39||0.316|TWO_SIDED|95.0|-4.2|1.4|||ANCOVA||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Post-baseline least squares means and p-values were from an ANCOVA model with main effect of study site and treatment with baseline value as a covariate. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.||1.4|-4.2|0.316
72379818|NCT02129777|144268061|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.1|STANDARD_ERROR_OF_MEAN|1.41||0.142|TWO_SIDED|95.0|-4.9|0.7|||ANCOVA||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Post-baseline least squares means and p-values were from an ANCOVA model with main effect of study site and treatment with baseline value as a covariate. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.||0.7|-4.9|0.142
72379819|NCT02129777|144268062|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.1|STANDARD_ERROR_OF_MEAN|1.73||0.229|TWO_SIDED|95.0|-5.6|1.4|||ANCOVA||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Physical Health Summary Score: Post-baseline least squares means and p-values were from an ANCOVA model with main effect of study site and treatment with baseline value as a covariate. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.||1.4|-5.6|0.229
72379820|NCT02129777|144268062|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|1.65||0.863|TWO_SIDED|95.0|-3.6|3.0|||ANCOVA||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Physical Health Summary Score: Post-baseline least squares means and p-values were from an ANCOVA model with main effect of study site and treatment with baseline value as a covariate. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.||3.0|-3.6|0.863
72379821|NCT02129777|144268062|SUPERIORITY_OR_OTHER||LS Mean Difference|1.4|STANDARD_ERROR_OF_MEAN|1.67||0.403|TWO_SIDED|95.0|-1.9|4.7|||ANCOVA||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Physical Health Summary Score: Post-baseline least squares means and p-values were from an ANCOVA model with main effect of study site and treatment with baseline value as a covariate. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.||4.7|-1.9|0.403
72379822|NCT02129777|144268062|SUPERIORITY_OR_OTHER||LS Mean Difference|0.9|STANDARD_ERROR_OF_MEAN|1.74||0.597|TWO_SIDED|95.0|-2.5|4.4|||ANCOVA||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Physical Health Summary Score: Post-baseline least squares means and p-values were from an ANCOVA model with main effect of study site and treatment with baseline value as a covariate. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.||4.4|-2.5|0.597
72556342|NCT00862563|144643985|SUPERIORITY_OR_OTHER|||||||0.038|TWO_SIDED|||||p\<0.01 is considered to be significant.|Mixed Models Analysis|p value shown is for the group x time effect.||Data were analyzed using two-way repeated measures mixed models analysis. It was hypothesized that Spatial Span scores would change towards a downward direction for the zonisamide as compared to the placebo group resulting in significant treatment x time interaction.||||0.038
72379823|NCT02129777|144268062|SUPERIORITY_OR_OTHER||LS Mean Difference|1.9|STANDARD_ERROR_OF_MEAN|2.32||0.416|TWO_SIDED|95.0|-2.7|6.5|||ANCOVA||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Mental Health Summary Score: Post-baseline least squares means and p-values were from an ANCOVA model with main effect of study site and treatment with baseline value as a covariate. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.||6.5|-2.7|0.416
72379824|NCT02129777|144268062|SUPERIORITY_OR_OTHER||LS Mean Difference|0.7|STANDARD_ERROR_OF_MEAN|2.24||0.77|TWO_SIDED|95.0|-3.8|5.1|||ANCOVA||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Mental Health Summary Score: Post-baseline least squares means and p-values were from an ANCOVA model with main effect of study site and treatment with baseline value as a covariate. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.||5.1|-3.8|0.770
72379825|NCT02129777|144268062|SUPERIORITY_OR_OTHER||LS Mean Difference|0.6|STANDARD_ERROR_OF_MEAN|2.31||0.798|TWO_SIDED|95.0|-4.0|5.2|||ANCOVA||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Mental Health Summary Score: Post-baseline least squares means and p-values were from an ANCOVA model with main effect of study site and treatment with baseline value as a covariate. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.||5.2|-4.0|0.798
72379826|NCT02129777|144268062|SUPERIORITY_OR_OTHER||LS Mean Difference|0.7|STANDARD_ERROR_OF_MEAN|2.4||0.767|TWO_SIDED|95.0|-4.1|5.5|||ANCOVA||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Mental Health Summary Score: Post-baseline least squares means and p-values were from an ANCOVA model with main effect of study site and treatment with baseline value as a covariate. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.||5.5|-4.1|0.767
72379827|NCT02129777|144268063|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.043||0.57|TWO_SIDED|95.0|-0.11|0.06|||ANCOVA||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Post-baseline least squares means and p-values were from an ANCOVA model with main effect of study site and treatment with baseline value as a covariate. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.||0.06|-0.11|0.570
72379828|NCT02129777|144268063|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.042||0.619|TWO_SIDED|95.0|-0.1|0.06|||ANCOVA||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Post-baseline least squares means and p-values were from an ANCOVA model with main effect of study site and treatment with baseline value as a covariate. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.||0.06|-0.10|0.619
72379829|NCT02129777|144268063|SUPERIORITY_OR_OTHER||LS Mean Difference|0.02|STANDARD_ERROR_OF_MEAN|0.043||0.597|TWO_SIDED|95.0|-0.06|0.11|||ANCOVA||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Post-baseline least squares means and p-values were from an ANCOVA model with main effect of study site and treatment with baseline value as a covariate. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.||0.11|-0.06|0.597
72379830|NCT02129777|144268063|SUPERIORITY_OR_OTHER||LS Mean Difference|0.03|STANDARD_ERROR_OF_MEAN|0.044||0.509|TWO_SIDED|95.0|-0.06|0.12|||ANCOVA||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Post-baseline least squares means and p-values were from an ANCOVA model with main effect of study site and treatment with baseline value as a covariate. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.||0.12|-0.06|0.509
72379831|NCT02129777|144268064|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|5.32||0.845|TWO_SIDED|95.0|-11.7|9.6|||ANCOVA||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Post-baseline least squares means and p-values were from an ANCOVA model with main effect of study site and treatment with baseline value as a covariate. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.||9.6|-11.7|0.845
72379832|NCT02129777|144268064|SUPERIORITY_OR_OTHER||LS Mean Difference|4.8|STANDARD_ERROR_OF_MEAN|4.8||0.323|TWO_SIDED|95.0|-4.8|14.4|||ANCOVA||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Post-baseline least squares means and p-values were from an ANCOVA model with main effect of study site and treatment with baseline value as a covariate. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.||14.4|-4.8|0.323
72379833|NCT02129777|144268064|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.9|STANDARD_ERROR_OF_MEAN|4.89||0.697|TWO_SIDED|95.0|-11.7|7.8|||ANCOVA||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Post-baseline least squares means and p-values were from an ANCOVA model with main effect of study site and treatment with baseline value as a covariate. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.||7.8|-11.7|0.697
72556343|NCT00862563|144643985|SUPERIORITY_OR_OTHER|||||||0.0025|TWO_SIDED|||||p\<0.01 is considered to be significant.|Mixed Models Analysis|p value shown is for the group x time interaction effect.||Data were analyzed using two-way repeated measures mixed models analysis. It was hypothesized that Digit span scores would change towards a downward direction for the topiramate as compared to the placebo group resulting in significant treatment x time interaction.||||0.0025
72618540|NCT01026038|144768104|SUPERIORITY_OR_OTHER|||||||0.633||95.0|||||Fisher Exact|||Pain (Moderate): Fisher exact test, 2-sided was used. Pairwise comparison was made between 7vPnC/7vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.||||0.633
72618541|NCT01026038|144768104|SUPERIORITY_OR_OTHER|||||||0.658||95.0|||||Fisher Exact|||Pain (Moderate): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.||||0.658
72618542|NCT01026038|144768104|SUPERIORITY_OR_OTHER|||||||0.544||95.0|||||Fisher Exact|||Pain (Severe): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/7vPnC/13vPnC.||||0.544
72379834|NCT02129777|144268064|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.4|STANDARD_ERROR_OF_MEAN|5.1||0.633|TWO_SIDED|95.0|-12.6|7.7|||ANCOVA||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Post-baseline least squares means and p-values were from an ANCOVA model with main effect of study site and treatment with baseline value as a covariate. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.||7.7|-12.6|0.633
72379835|NCT02129777|144268065|SUPERIORITY_OR_OTHER||LS Mean Difference|1.0|STANDARD_ERROR_OF_MEAN|1.64||0.537|TWO_SIDED|95.0|-2.2|4.3|||MMRM||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Week 12: Post-baseline least squares means and p-values were from a MMRM model with main effect of study site,treatment,visit and interaction between visit and treatment as fixed effects,baseline value as a covariate with an unstructured covariance structure. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.||4.3|-2.2|0.537
72379836|NCT02129777|144268065|SUPERIORITY_OR_OTHER||LS Mean Difference|2.4|STANDARD_ERROR_OF_MEAN|1.62||0.142|TWO_SIDED|95.0|-0.8|5.6|||MMRM||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Week 12: Post-baseline least squares means and p-values were from a MMRM model with main effect of study site,treatment,visit and interaction between visit and treatment as fixed effects,baseline value as a covariate with an unstructured covariance structure. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.||5.6|-0.8|0.142
72379837|NCT02129777|144268065|SUPERIORITY_OR_OTHER||LS Mean Difference|4.0|STANDARD_ERROR_OF_MEAN|1.63||0.015|TWO_SIDED|95.0|0.8|7.3|||MMRM||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Week 12: Post-baseline least squares means and p-values were from a MMRM model with main effect of study site,treatment,visit and interaction between visit and treatment as fixed effects,baseline value as a covariate with an unstructured covariance structure. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.||7.3|0.8|0.015
72379838|NCT02129777|144268065|SUPERIORITY_OR_OTHER||LS Mean Difference|2.6|STANDARD_ERROR_OF_MEAN|1.64||0.121|TWO_SIDED|95.0|-0.7|5.8|||MMRM||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Week 12: Post-baseline least squares means and p-values were from a MMRM model with main effect of study site,treatment,visit and interaction between visit and treatment as fixed effects,baseline value as a covariate with an unstructured covariance structure. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.||5.8|-0.7|0.121
72379839|NCT01754909|144268087|SUPERIORITY|Occurrence rates, comparison by t test||||||0.05|||||||t-test, 2 sided|||||||0.05
72379840|NCT01923168|144268132|OTHER|Bayesian double criteria|Mean Difference (Final Values)|-1.3||||0.282|TWO_SIDED|80.0|-4.5|1.7|||Posterior mean diff. & credible interval|||||1.7|-4.5|0.282
72379841|NCT01923168|144268133|OTHER|Bayesian double criteria|Mean Difference (Final Values)|1.1||||0.697|TWO_SIDED|80.0|-1.9|4.2|||Posterior mean difference|Posterior mean difference||||4.2|-1.9|0.697
72379842|NCT01923168|144268134|OTHER|Bayesian double criteria|Mean Difference (Final Values)|-1.4||||0.435|TWO_SIDED|80.0|-12.5|9.7|||Posterior mean diff. & credible interval|||||9.7|-12.5|0.435
72379843|NCT01923168|144268135|OTHER|Bayesian double criteria|Mean Difference (Final Values)|2.4||||0.611|TWO_SIDED|80.0|-8.4|13.2|||Posterior mean diff. & credible interval|||||13.2|-8.4|0.611
72379844|NCT01255787|144268170|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.61|STANDARD_ERROR_OF_MEAN|1.123||0.907|TWO_SIDED|95.0|-3.258|2.035||Adjustment for multiplicity for the comparisons was based on the Dunnett-Hsu procedure.|ANCOVA|Analysis of covariance (ANCOVA), with treatment as a fixed factors and baseline MADRS as a covariate.||All statistical tests were 2-sided with the estimated P-values at the 5% level of significance.||2.035|-3.258|0.9070
72379845|NCT01255787|144268170|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.69|STANDARD_ERROR_OF_MEAN|1.114||0.3006|TWO_SIDED|95.0|-4.31|0.938|||ANCOVA|Analysis of covariance (ANCOVA), with treatment as a fixed factors and baseline MADRS as a covariate.||||0.938|-4.310|0.3006
72379846|NCT01255787|144268170|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.82|STANDARD_ERROR_OF_MEAN|1.11||0.2399|TWO_SIDED|95.0|-4.436|0.794|||ANCOVA|Analysis of covariance (ANCOVA), with treatment as a fixed factors and baseline MADRS as a covariate.||||0.794|-4.436|0.2399
72379847|NCT03519386|144268184|NON_INFERIORITY|criteria for statistical and clinical non-inferiority: upper limit of the 95% CI of the difference between the implant group and the timolol group was \< 1.5 mmHg and also \< 1 mmHg for all 6 timepoints for Implant Group 2 vs. Timolol|Mean Difference (Final Values)|-0.79|||||TWO_SIDED|95.0|-1.45|-0.13||"Fixed sequence hierarchical testing procedure was used, first testing for non-inferiority of Implant Group 2 to timolol at all 6 timepoints before testing non-inferiority of Implant Group~1 to timolol"||||Day 10, 8AM Difference between Implant Group 2 and timolol||-0.13|-1.45|
72379848|NCT03519386|144268184|NON_INFERIORITY|criteria for statistical and clinical non-inferiority: upper limit of the 95% CI of the difference between the implant group and the timolol group was \< 1.5 mmHg and also \< 1 mmHg for all 6 timepoints for Implant Group 2 vs Timolol|Mean Difference (Final Values)|-1.24|||||TWO_SIDED|95.0|-1.92|-0.56||"Fixed sequence hierarchical testing procedure was used, first testing for non-inferiority of Implant Group 2 to timolol at all 6 timepoints before testing non-inferiority of Implant Group~1 to timolol"||||Day 10, 10AM Difference between Implant Group 2 and timolol||-0.56|-1.92|
72379849|NCT03519386|144268184|NON_INFERIORITY|criteria for statistical and clinical non-inferiority: upper limit of the 95% CI of the difference between the implant group and the timolol group was \< 1.5 mmHg and also \< 1 mmHg for all 6 timepoints for Implant Group 2 vs Timolol|Mean Difference (Final Values)|-0.18|||||TWO_SIDED|95.0|-0.86|0.51||"Fixed sequence hierarchical testing procedure was used, first testing for non-inferiority of Implant Group 2 to timolol at all 6 timepoints before testing non-inferiority of Implant Group~1 to timolol"||||Week 6, 8AM Difference between Implant Group 2 and timolol||0.51|-0.86|
72618543|NCT01026038|144768104|SUPERIORITY_OR_OTHER||||||>|0.99||95.0|||||Fisher Exact|||Pain (Severe): Fisher exact test, 2-sided was used. Pairwise comparison was made between 7vPnC/7vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.||||>0.990
72618544|NCT01026038|144768104|SUPERIORITY_OR_OTHER||||||>|0.99||95.0|||||Fisher Exact|||Pain (Severe): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.||||>0.990
72379850|NCT03519386|144268184|NON_INFERIORITY|criteria for statistical and clinical non-inferiority: upper limit of the 95% CI of the difference between the implant group and the timolol group was \< 1.5 mmHg and also \< 1 mmHg for all 6 timepoints for Implant Group 2 vs Timolol|Mean Difference (Final Values)|-0.77|||||TWO_SIDED|95.0|-1.43|-0.11||"Fixed sequence hierarchical testing procedure was used, first testing for non-inferiority of Implant Group 2 to timolol at all 6 timepoints before testing non-inferiority of Implant Group~1 to timolol"||||Week 6, 10AM Difference between Implant Group 2 and timolol||-0.11|-1.43|
72379851|NCT03519386|144268184|NON_INFERIORITY|criteria for statistical and clinical non-inferiority: upper limit of the 95% CI of the difference between the implant group and the timolol group was \< 1.5 mmHg and also \< 1 mmHg for all 6 timepoints for Implant Group 2 vs Timolol|Mean Difference (Final Values)|0.1|||||TWO_SIDED|95.0|-0.63|0.82||"Fixed sequence hierarchical testing procedure was used, first testing for non-inferiority of Implant Group 2 to timolol at all 6 timepoints before testing non-inferiority of Implant Group~1 to timolol"||||Month 3, 8AM Difference between Implant Group 2 and timolol||0.82|-0.63|
72379852|NCT03519386|144268184|NON_INFERIORITY|criteria for statistical and clinical non-inferiority: upper limit of the 95% CI of the difference between the implant group and the timolol group was \< 1.5 mmHg and also \< 1 mmHg for all 6 timepoints for Implant Group 2 vs Timolol|Mean Difference (Final Values)|-0.16|||||TWO_SIDED|95.0|-0.89|0.57||"Fixed sequence hierarchical testing procedure was used, first testing for non-inferiority of Implant Group 2 to timolol at all 6 timepoints before testing non-inferiority of Implant Group~1 to timolol"||||Month 3, 10AM Difference between Implant Group 2 and timolol||0.57|-0.89|
72379853|NCT03519386|144268184|NON_INFERIORITY|criteria for statistical and clinical non-inferiority: upper limit of the 95% CI of the difference between the implant group and the timolol group was \< 1.5 mmHg and also \< 1 mmHg for all 6 timepoints for Implant Group 1 vs. Timolol|Mean Difference (Final Values)|-0.72|||||TWO_SIDED|95.0|-1.38|-0.06||"Fixed sequence hierarchical testing procedure was used, first testing for non-inferiority of Implant Group 2 to timolol at all 6 timepoints before testing non-inferiority of Implant Group~1 to timolol"||||Day 10, 8AM Difference between Implant Group 1 vs. Timolol||-0.06|-1.38|
72379854|NCT03519386|144268184|NON_INFERIORITY|criteria for statistical and clinical non-inferiority: upper limit of the 95% CI of the difference between the implant group and the timolol group was \< 1.5 mmHg and also \< 1 mmHg for all 6 timepoints for Implant Group 1 vs Timolol|Mean Difference (Final Values)|-1.15|||||TWO_SIDED|95.0|-1.83|-0.48||"Fixed sequence hierarchical testing procedure was used, first testing for non-inferiority of Implant Group 2 to timolol at all 6 timepoints before testing non-inferiority of Implant Group~1 to timolol"||||Day 10, 10AM Difference between Implant Group 1 vs. Timolol||-0.48|-1.83|
72379855|NCT03519386|144268184|NON_INFERIORITY|criteria for statistical and clinical non-inferiority: upper limit of the 95% CI of the difference between the implant group and the timolol group was \< 1.5 mmHg and also \< 1 mmHg for all 6 timepoints for Implant Group 1 vs. Timolol|Mean Difference (Final Values)|-0.25|||||TWO_SIDED|95.0|-0.93|0.43||"Fixed sequence hierarchical testing procedure was used, first testing for non-inferiority of Implant Group 2 to timolol at all 6 timepoints before testing non-inferiority of Implant Group~1 to timolol"||||Week 6, 8AM Difference between Implant Group 1 and timolol||0.43|-0.93|
72379856|NCT03519386|144268184|NON_INFERIORITY|criteria for statistical and clinical non-inferiority: upper limit of the 95% CI of the difference between the implant group and the timolol group was \< 1.5 mmHg and also \< 1 mmHg for all 6 timepoints for Implant Group 1 vs Timolol|Mean Difference (Final Values)|-0.74|||||TWO_SIDED|95.0|-1.4|-0.08||"Fixed sequence hierarchical testing procedure was used, first testing for non-inferiority of Implant Group 2 to timolol at all 6 timepoints before testing non-inferiority of Implant Group~1 to timolol"||||Week 6, 10AM Difference between Implant Group 1 and timolol||-0.08|-1.40|
72379857|NCT03519386|144268184|NON_INFERIORITY|criteria for statistical and clinical non-inferiority: upper limit of the 95% CI of the difference between the implant group and the timolol group was \< 1.5 mmHg and also \< 1 mmHg for all 6 timepoints for Implant Group 1 vs. Timolol|Mean Difference (Final Values)|0.1|||||TWO_SIDED|95.0|-0.62|0.83||"Fixed sequence hierarchical testing procedure was used, first testing for non-inferiority of Implant Group 2 to timolol at all 6 timepoints before testing non-inferiority of Implant Group~1 to timolol"||||Month 3, 8AM Difference between Implant Group 1 and timolol||0.83|-0.62|
72379858|NCT03519386|144268184|NON_INFERIORITY|criteria for statistical and clinical non-inferiority: upper limit of the 95% CI of the difference between the implant group and the timolol group was \< 1.5 mmHg and also \< 1 mmHg for all 6 timepoints for Implant Group 1 vs Timolol|Mean Difference (Final Values)|-0.04|||||TWO_SIDED|95.0|-0.77|0.69||"Fixed sequence hierarchical testing procedure was used, first testing for non-inferiority of Implant Group 2 to timolol at all 6 timepoints before testing non-inferiority of Implant Group~1 to timolol"||||Month 3, 10AM Difference between Implant Group 1 and timolol||0.69|-0.77|
72379859|NCT03101267|144268221|SUPERIORITY||Adjusted mean difference|0.09||||0.777|TWO_SIDED|95.0|-0.52|0.69|||Mixed model for repeated measures (MMRM)|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||3TNSS treatment comparison||0.69|-0.52|0.777
72379860|NCT03101267|144268221|SUPERIORITY||Adjusted mean difference|-0.01||||0.983||95.0|-0.61|0.59|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||3TNSS treatment comparison||0.59|-0.61|0.983
72379861|NCT03101267|144268222|SUPERIORITY||Adjusted mean difference|0.17||||0.71|TWO_SIDED|95.0|-0.75|1.1|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||4TNSS treatment comparison at day 127||1.10|-0.75|0.710
72618545|NCT01026038|144768104|SUPERIORITY_OR_OTHER|||||||0.859||95.0|||||Fisher Exact|||Swelling (Any): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/7vPnC/13vPnC.||||0.859
72618546|NCT01026038|144768104|SUPERIORITY_OR_OTHER|||||||0.197||95.0|||||Fisher Exact|||Swelling (Any): Fisher exact test, 2-sided was used. Pairwise comparison was made between 7vPnC/7vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.||||0.197
72379862|NCT03101267|144268222|SUPERIORITY||Adjusted mean difference|0.07||||0.872|TWO_SIDED|95.0|-0.84|0.99|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||4TNSS treatment comparison at day 127||0.99|-0.84|0.872
72379863|NCT03101267|144268222|SUPERIORITY||Adjusted mean difference|0.18||||0.701|TWO_SIDED|95.0|-0.73|1.08|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||4TNSS treatment comparison at day 155||1.08|-0.73|0.701
72556344|NCT00862563|144643985|SUPERIORITY_OR_OTHER|||||||0.3|TWO_SIDED|||||p\<0.01 is considered to be significant|Mixed Models Analysis|p value shown is for the group x time interaction effect.||Data were analyzed using two-way repeated measures mixed models analysis. It was hypothesized that Digit span scores would change towards a downward direction for the levetiracetam as compared to the placebo group resulting in significant treatment x time interaction.||||0.3
72379864|NCT03101267|144268222|SUPERIORITY||Adjusted mean difference|-0.04||||0.925||95.0|-0.95|0.86|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||4TNSS treatment comparison at day 155||0.86|-0.95|0.925
72379865|NCT03101267|144268222|SUPERIORITY||Adjusted mean difference|0.16||||0.69|TWO_SIDED|95.0|-0.64|0.97|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||4TNSS treatment comparison at day 183||0.97|-0.64|0.690
72379866|NCT03101267|144268222|SUPERIORITY||Adjusted mean difference|0.07||||0.868|TWO_SIDED|95.0|-0.73|0.87|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||4TNSS treatment comparison at day 183||0.87|-0.73|0.868
72379867|NCT03101267|144268223|SUPERIORITY||Adjusted mean difference|0.07||||0.502|TWO_SIDED|95.0|-0.14|0.29|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||Sneezing score treatment comparison at day 127||0.29|-0.14|0.502
72379868|NCT03101267|144268223|SUPERIORITY||Adjusted mean difference|-0.02||||0.879|TWO_SIDED|95.0|-0.23|0.2|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||Sneezing score treatment comparison at day 127||0.20|-0.23|0.879
72379869|NCT03101267|144268223|SUPERIORITY||Adjusted mean difference|0.06||||0.444|TWO_SIDED|95.0|-0.1|0.22|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||Sneezing score treatment comparison at day 155||0.22|-0.10|0.444
72379870|NCT03101267|144268223|SUPERIORITY||Adjusted mean difference|0.0||||0.987|TWO_SIDED|95.0|-0.16|0.16|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||Sneezing score treatment comparison at day 155||0.16|-0.16|0.987
72379871|NCT03101267|144268223|SUPERIORITY||Adjusted mean difference|0.03||||0.645|TWO_SIDED|95.0|-0.12|0.18|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||Sneezing score treatment comparison at day 183||0.18|-0.12|0.645
72379872|NCT03101267|144268223|SUPERIORITY||Adjusted mean difference|-0.07||||0.357|TWO_SIDED|95.0|-0.22|0.08|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||Sneezing score treatment comparison at day 183||0.08|-0.22|0.357
72379873|NCT03101267|144268224|SUPERIORITY||Adjusted mean difference|0.12||||0.472|TWO_SIDED|95.0|-0.2|0.44|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||Nasal discharge score treatment comparison at day 127||0.44|-0.20|0.472
72379874|NCT03101267|144268224|SUPERIORITY||Adjusted mean difference|-0.11||||0.497|TWO_SIDED|95.0|-0.43|0.21|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||Nasal discharge score treatment comparison at day 127||0.21|-0.43|0.497
72379875|NCT03101267|144268224|SUPERIORITY||Adjusted mean difference|0.04||||0.821|TWO_SIDED|95.0|-0.28|0.36|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||Nasal discharge score treatment comparison at day 155||0.36|-0.28|0.821
72379876|NCT03101267|144268224|SUPERIORITY||Adjusted mean difference|-0.13||||0.414|TWO_SIDED|95.0|-0.45|0.19|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||Nasal discharge score treatment comparison at day 155||0.19|-0.45|0.414
72556345|NCT03246503|144643998|OTHER||Pearson correlation coefficient|0.82|||<|0.001|TWO_SIDED|95.0|0.77|0.87||statistical significance of Pearson correlation coefficient|Pearson correlation coefficient||Bootstrapping with 1000 replications was used to estimate 95% confidence intervals.|Bootstrapping with 1000 replications was used to estimate 95% confidence intervals.||.87|0.77|<.001
72379877|NCT03101267|144268224|SUPERIORITY||Adjusted mean difference|0.12||||0.414|TWO_SIDED|95.0|-0.17|0.41|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||Nasal discharge score treatment comparison at day 183||0.41|-0.17|0.414
72379878|NCT03101267|144268224|SUPERIORITY||Adjusted mean difference|0.08||||0.566|TWO_SIDED|95.0|-0.2|0.37|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||Nasal discharge score treatment comparison at day 183||0.37|-0.20|0.566
72379879|NCT03101267|144268225|SUPERIORITY||Adjusted mean difference|-0.04||||0.822||95.0|-0.37|0.3|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||Nasal congestion score treatment comparison at day 127||0.30|-0.37|0.822
72556346|NCT03246503|144643999|OTHER|t-statistic from regression analysis|intercept of regression line|4.13|||<|0.001|TWO_SIDED|95.0|3.35|4.91|||Regression, Linear|||||4.91|3.35|<.001
72379880|NCT03101267|144268225|SUPERIORITY||Adjusted mean difference|0.09||||0.587|TWO_SIDED|95.0|-0.24|0.42|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||Nasal congestion score treatment comparison at day 127||0.42|-0.24|0.587
72379881|NCT03101267|144268225|SUPERIORITY||Adjusted mean difference|0.0||||0.975|TWO_SIDED|95.0|-0.3|0.31|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||Nasal congestion score treatment comparison at day 155||0.31|-0.30|0.975
72379882|NCT03101267|144268225|SUPERIORITY||Adjusted mean difference|0.0||||0.98|TWO_SIDED|95.0|-0.31|0.31|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||Nasal congestion score treatment comparison at day 155||0.31|-0.31|0.980
72556347|NCT03246503|144644000|OTHER|t-statistic from regression analysis|Slope|0.68|||<|0.001|TWO_SIDED|95.0|0.6|0.76|||Regression, Linear|||||0.76|0.60|<.001
72379883|NCT03101267|144268225|SUPERIORITY||Adjusted mean difference|-0.07||||0.621|TWO_SIDED|95.0|-0.35|0.21|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||Nasal congestion score treatment comparison at day 183||0.21|-0.35|0.621
72379884|NCT03101267|144268225|SUPERIORITY||Adjusted mean difference|-0.03||||0.831|TWO_SIDED|95.0|-0.31|0.25|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||Nasal congestion score treatment comparison at day 183||0.25|-0.31|0.831
72379885|NCT03101267|144268226|SUPERIORITY||Adjusted mean difference|0.03||||0.864|TWO_SIDED|95.0|-0.29|0.35|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||Itchy nose score treatment comparison at day 127||0.35|-0.29|0.864
72379886|NCT03101267|144268226|SUPERIORITY||Adjusted mean difference|0.11||||0.502|TWO_SIDED|95.0|-0.21|0.43|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||Itchy nose score treatment comparison at day 127||0.43|-0.21|0.502
72379887|NCT03101267|144268226|SUPERIORITY||Adjusted mean difference|0.07||||0.652|TWO_SIDED|95.0|-0.25|0.4|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||Itchy nose score treatment comparison at day 155||0.40|-0.25|0.652
72379888|NCT03101267|144268226|SUPERIORITY||Adjusted mean difference|0.08||||0.633|TWO_SIDED|95.0|-0.25|0.41|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||Itchy nose score treatment comparison at day 155||0.41|-0.25|0.633
72379889|NCT03101267|144268226|SUPERIORITY||Adjusted mean difference|0.07||||0.596|TWO_SIDED|95.0|-0.2|0.35|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||Itchy nose score treatment comparison at day 183||0.35|-0.20|0.596
72379890|NCT03101267|144268226|SUPERIORITY||Adjusted mean difference|0.07||||0.621|TWO_SIDED|95.0|-0.21|0.34|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||Itchy nose score treatment comparison at day 183||0.34|-0.21|0.621
72379891|NCT03101267|144268227|SUPERIORITY||Adjusted mean difference|0.21||||0.336|TWO_SIDED|95.0|-0.22|0.65|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||TNNSS treatment comparison at day 127||0.65|-0.22|0.336
72379892|NCT03101267|144268227|SUPERIORITY||Adjusted mean difference|0.36||||0.102|TWO_SIDED|95.0|-0.07|0.8|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||TNNSS treatment comparison at day 127||0.80|-0.07|0.102
72379893|NCT03101267|144268227|SUPERIORITY||Adjusted mean difference|0.11||||0.625|TWO_SIDED|95.0|-0.34|0.56|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||TNNSS treatment comparison at day 155||0.56|-0.34|0.625
72379894|NCT03101267|144268227|SUPERIORITY||Adjusted mean difference|0.33||||0.145|TWO_SIDED|95.0|-0.12|0.78|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||TNNSS treatment comparison at day 155||0.78|-0.12|0.145
72618547|NCT01026038|144768104|SUPERIORITY_OR_OTHER|||||||0.198||95.0|||||Fisher Exact|||Swelling (Any): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.||||0.198
72379895|NCT03101267|144268227|SUPERIORITY||Adjusted mean difference|0.19||||0.364|TWO_SIDED|95.0|-0.22|0.59|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||TNNSS treatment comparison at day 183||0.59|-0.22|0.364
72379896|NCT03101267|144268227|SUPERIORITY||Adjusted mean difference|0.35||||0.082|TWO_SIDED|95.0|-0.05|0.76|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||TNNSS treatment comparison at day 183||0.76|-0.05|0.082
72379897|NCT03101267|144268228|SUPERIORITY||Adjusted mean difference|0.07||||0.623|TWO_SIDED|95.0|-0.21|0.35|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||Itchy eyes treatment comparison at day 127||0.35|-0.21|0.623
72379898|NCT03101267|144268228|SUPERIORITY||Adjusted mean difference|0.15||||0.288|TWO_SIDED|95.0|-0.13|0.43|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||Itchy eyes treatment comparison at day 127||0.43|-0.13|0.288
72379899|NCT03101267|144268228|SUPERIORITY||Adjusted mean difference|0.03||||0.83|TWO_SIDED|95.0|-0.24|0.3|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||Itchy eyes treatment comparison at day 155||0.30|-0.24|0.830
72379900|NCT03101267|144268228|SUPERIORITY||Adjusted mean difference|0.17||||0.208|TWO_SIDED|95.0|-0.1|0.44|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||Itchy eyes treatment comparison at day 155||0.44|-0.10|0.208
72379901|NCT03101267|144268228|SUPERIORITY||Adjusted mean difference|0.06||||0.616|TWO_SIDED|95.0|-0.19|0.31|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||Itchy eyes treatment comparison at day 183||0.31|-0.19|0.616
72379902|NCT03101267|144268228|SUPERIORITY||Adjusted mean difference|0.16||||0.207|TWO_SIDED|95.0|-0.09|0.41|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||Itchy eyes treatment comparison at day 183||0.41|-0.09|0.207
72379903|NCT03101267|144268229|SUPERIORITY||Adjusted mean difference|0.15||||0.157|TWO_SIDED|95.0|-0.06|0.35|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||Watery eyes treatment comparison at day 127||0.35|-0.06|0.157
72379904|NCT03101267|144268229|SUPERIORITY||Adjusted mean difference|0.21||||0.039|TWO_SIDED|95.0|0.01|0.41|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||Watery eyes treatment comparison at day 127||0.41|0.01|0.039
72556348|NCT01492439|144644019|SUPERIORITY_OR_OTHER|||||||0.029||||||This applies to Semester 1.|t-test, 1 sided|||||||0.029
72379905|NCT03101267|144268229|SUPERIORITY||Adjusted mean difference|0.08||||0.459|TWO_SIDED|95.0|-0.14|0.3|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||Watery eyes treatment comparison at day 155||0.30|-0.14|0.459
72379906|NCT03101267|144268229|SUPERIORITY||Adjusted mean difference|0.16||||0.153|TWO_SIDED|95.0|-0.06|0.38|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||Watery eyes treatment comparison at day 155||0.38|-0.06|0.153
72379907|NCT03101267|144268229|SUPERIORITY||Adjusted mean difference|0.12||||0.195|TWO_SIDED|95.0|-0.06|0.31|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||Watery eyes treatment comparison at day 183||0.31|-0.06|0.195
72379908|NCT03101267|144268229|SUPERIORITY||Adjusted mean difference|0.2||||0.038|TWO_SIDED|95.0|0.01|0.38|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||Watery eyes treatment comparison at day 183||0.38|0.01|0.038
72379909|NCT03101267|144268230|SUPERIORITY||Adjusted mean difference|0.37||||0.433|TWO_SIDED|95.0|-0.56|1.29|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||5TSS treatment comparison at day 127||1.29|-0.56|0.433
72379910|NCT03101267|144268230|SUPERIORITY||Adjusted mean difference|0.33||||0.479|TWO_SIDED|95.0|-0.59|1.24|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||5TSS treatment comparison at day 127||1.24|-0.59|0.479
72379911|NCT03101267|144268230|SUPERIORITY||Adjusted mean difference|0.22||||0.648|TWO_SIDED|95.0|-0.71|1.14|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||5TSS treatment comparison at day 155||1.14|-0.71|0.648
72379912|NCT03101267|144268230|SUPERIORITY||Adjusted mean difference|0.21||||0.654|TWO_SIDED|95.0|-0.72|1.14|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||5TSS treatment comparison at day 155||1.14|-0.72|0.654
72379913|NCT03101267|144268230|SUPERIORITY||Adjusted mean difference|0.27||||0.514|TWO_SIDED|95.0|-0.55|1.09|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||5TSS treatment comparison at day 183||1.09|-0.55|0.514
72379914|NCT03101267|144268230|SUPERIORITY||Adjusted mean difference|0.35||||0.4|TWO_SIDED|95.0|-0.47|1.17|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||5TSS treatment comparison at day 183||1.17|-0.47|0.400
72379915|NCT03101267|144268231|SUPERIORITY||Adjusted mean difference,|0.39||||0.505|TWO_SIDED|95.0|-0.76|1.54||The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.|MMRM|||6TSS treatment comparison at day 127||1.54|-0.76|0.505
72379916|NCT03101267|144268231|SUPERIORITY||Adjusted mean difference,|0.44||||0.451|TWO_SIDED|95.0|-0.71|1.58|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||6TSS treatment comparison at day 127||1.58|-0.71|0.451
72556349|NCT01492439|144644019|SUPERIORITY_OR_OTHER|||||||0.225||||||This applies to semester 2.|t-test, 1 sided|||||||0.225
72379917|NCT03101267|144268231|SUPERIORITY||Adjusted mean difference,|0.29||||0.623|TWO_SIDED|95.0|-0.88|1.46|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||6TSS treatment comparison at day 155||1.46|-0.88|0.623
72379918|NCT03101267|144268231|SUPERIORITY||Adjusted mean difference,|0.29||||0.62|TWO_SIDED|95.0|-0.87|1.46|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||6TSS treatment comparison at day 155||1.46|-0.87|0.620
72379919|NCT03101267|144268231|SUPERIORITY||Adjusted mean difference,|0.35||||0.504|TWO_SIDED|95.0|-0.68|1.37|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||6TSS treatment comparison at day 183||1.37|-0.68|0.504
72379920|NCT03101267|144268231|SUPERIORITY||Adjusted mean difference,|0.42||||0.414|TWO_SIDED|95.0|-0.6|1.45|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||6TSS treatment comparison at day 183||1.45|-0.60|0.414
72379921|NCT02398227|144268240|SUPERIORITY|||||||0.968|||||||ANCOVA|p value reported for overall effect across all-time points between treatment arms||||||.968
72379922|NCT02398227|144268241|SUPERIORITY|||||||0.56|||||||ANCOVA|p value reported for overall effect across all-time points between treatment arms||||||.560
72379923|NCT01262352|144268254|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.069||||0.0004|TWO_SIDED|95.0|-2.98|-1.15|||Mixed Models Analysis|||The primary analysis for the primary efficacy variable was based on a mixed effect model. The model included the absolute change from the baseline in each period as the dependent variable, sequence, treatment, and period as fixed effects, study baseline LCI as the covariate, and subject nested within sequence as the random effect.||-1.15|-2.98|0.0004
72379924|NCT01262352|144268255|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.007||||0.0117|TWO_SIDED|95.0|1.8|12.21||P-value was not adjusted for multiple comparisons.|Mixed Models Analysis|||Analysis for this efficacy variable was performed in a similar way as the analysis for the primary efficacy variable.||12.21|1.80|0.0117
72379925|NCT01262352|144268256|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-45.848|||<|0.0001|TWO_SIDED|95.0|-53.54|-38.16||P-value was not adjusted for multiple comparisons.|Mixed Models Analysis|||Analysis for change from baseline in average sweat chloride was similar to the analysis of the primary efficacy variable.||-38.16|-53.54|<0.0001
72379926|NCT01262352|144268257|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.991||||0.3796|TWO_SIDED|95.0|-5.4|13.39||P-value was not adjusted for multiple comparisons.|Mixed Models Analysis|||The raw scores in CFQ-R were summarized into different domains of health (12 domains for adolescents and adults 14 years of age and older, 8 domains for children ages 12 and 13 years, 8 domains for children ages 6 to 11 years, and 11 domains for parents/caregivers). Each domain was analyzed in a similar way as for the primary efficacy variable. The primary analytical focus was the respiratory health domain which was analyzed by combining all self-response questionnaire versions.||13.39|-5.40|0.3796
72556350|NCT01492439|144644020|SUPERIORITY_OR_OTHER|||||||0.247||||||This applies to the 'positive' subscale of the PANSS.|ANCOVA|||||||0.247
72379927|NCT00107952|144268270|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin of 20% was specified based on historical regulatory precedent.|Risk Difference (RD)|-1.6||||||95.0|-8.6|5.5||p-values were not calculated in deference to confidence intervals.|||"Statistical analysis applies to cure"|||5.5|-8.6|
72379928|NCT01306877|144268299|NON_INFERIORITY_OR_EQUIVALENCE|The objective is to reject H0 at the 0.05 significance level. A one-sided 95% confidence upper limit for PC - PE will be constructed by Newcombe's generalized Wilson score method (Newcombe 1998). H0 will be rejected at the 0.05 significance level if this upper limit is \<7%.|Risk Difference (RD)|-0.314||||0.0001|ONE_SIDED|95.0||-0.18||P-value calculated from per protocol analysis set|Chi-squared|||||-0.18||0.0001
72379929|NCT01306877|144268303|SUPERIORITY_OR_OTHER|||||||0.1844|||||||Wilcoxon (Mann-Whitney)|||||||0.1844
72379930|NCT01306877|144268304|SUPERIORITY_OR_OTHER|||||||0.5647|||||||Wilcoxon (Mann-Whitney)|||||||0.5647
72379931|NCT01306877|144268305|SUPERIORITY_OR_OTHER|||||||0.9062|||||||Wilcoxon (Mann-Whitney)|||||||0.9062
72379932|NCT02376283|144268322|OTHER|A p value \< 0.05 was considered to be statistically significant.Comparison of means between groups assessed using ANOVA allowing comparison of more than 2 means and enabled assessment made of the relationship between different drugs (clopidogrel vs prasugrel vs ticagrelor), different clinical states (STEMI vs NSTEMI/UA (Unstable angina)) and different time points.|||||<|0.05||||||Assessment made of relationship between groups-clop vs pras vs tic,rows of STEMI vs NSTEMI/UA and different time points.P-values reported are calculated values based on data collated during sample collection and review of clinical characteristics.|ANOVA|||Continuous variables expressed as mean ± SD (standard deviation) and categorical variables as frequencies (%).Continuous variables analysed individually using student's independent sample t-tests. Categorical variables assessed using separate Fisher's exact (Chi-square) test.||||<0.05
72379933|NCT02376283|144268322|OTHER|Comparison of means between groups assessed using ANOVA allowing comparison of more than 2 means and enabled assessment made of the relationship between different drugs (clopidogrel vs prasugrel vs ticagrelor), different clinical states (STEMI vs NSTEMI/UA (Unstable angina)) and different time points.|||||<|0.0001|||||||ANOVA|ANOVA F(3,36) = 12.282||STEMI- clop vs prasl vs tic||||< 0.0001
72379934|NCT02376283|144268322|OTHER|Comparison of means between groups assessed using ANOVA allowing comparison of more than 2 means and enabled assessment made of the relationship between different drugs (clopidogrel vs prasugrel vs ticagrelor), different clinical states (STEMI vs NSTEMI/UA (Unstable angina)) and different time points.|||||<|0.0001||||||Assessment made of relationship between groups-clop vs pras vs tic,rows of STEMI vs NSTEMI/UA and different time points.P-values reported are calculated values based on data collated during sample collection and review of clinical characteristics.|ANOVA|ANOVA F(2,40) = 29.097||NSTEMI- clopidogrel vs prasugrel vs ticagrelor||||< 0.0001
72379935|NCT02376283|144268323|OTHER|Comparison of means between groups was assessed using analysis of variance (ANOVA) technique. ANOVA allowed for a comparison of more than two means and enabled an assessment to be made of the relationship between, different drugs (clopidogrel active metabolite vs prasugrel active metabolite vs ticagrelor parent compound and active metabolite), different clinical states (STEMI vs NSTEMI/UA (Unstable angina)) and different time points.|||||<|0.05||||||Assessment made of relationship between groups-clop vs pras vs tic, rows of STEMI vs NSTEMI/UA and different time points. P-values reported are calculated values based on data collated during sample collection and review of clinical characteristics.|ANOVA|||"Continuous variables were expressed as mean ± SEM (Standard Error of Measurement) and categorical variables as frequencies (%).~Continuous variables were analysed individually using student's independent sample t-tests. Categorical variables were assessed using separate Fisher's exact (Chi-square) test."||||<0.05
72379936|NCT02376283|144268323|OTHER|Comparison of means between groups was assessed using analysis of variance (ANOVA) technique. ANOVA allowed for a comparison of more than two means and enabled an assessment to be made of the relationship between, different drugs (clopidogrel active metabolite vs prasugrel active metabolite vs ticagrelor parent compound and active metabolite), different clinical states (STEMI vs NSTEMI/UA (Unstable angina)) and different time points.|||||=|0.123|||||||ANOVA|ANOVA F(6,56)=1.707||STEMI- different drugs (as stated above)||||=0.123
72379937|NCT02376283|144268323|OTHER|Comparison of means between groups was assessed using analysis of variance (ANOVA) technique. ANOVA allowed for a comparison of more than two means and enabled an assessment to be made of the relationship between, different drugs (clopidogrel active metabolite vs prasugrel active metabolite vs ticagrelor parent compound and active metabolite), different clinical states (STEMI vs NSTEMI/UA (Unstable angina)) and different time points.|||||<|0.0001||||||Assessment made of relationship between groups-clop vs pras vs tic, rows of STEMI vs NSTEMI/UA and different time points. P-values reported are calculated values based on data collated during sample collection and review of clinical characteristics.|ANOVA|ANOVA F(4,62)=18.932||NSTEMI- different drugs (as stated above)||||<0.0001
72379938|NCT02376283|144268324|OTHER|Comparison of means between groups was assessed using analysis of variance (ANOVA) technique. ANOVA allowed for a comparison of more than two means and enabled an assessment to be made of the relationship between, different drugs (clopidogrel vs prasugrel vs ticagrelor), different clinical states (STEMI vs NSTEMI/UA) and different time points.|||||<|0.05||||||Assessment made of relationship between groups-clop vs pras vs tic, rows of STEMI vs NSTEMI/UA and different time points. P-values reported are calculated values based on data collated during sample collection and review of clinical characteristics.|ANOVA|||"Continuous variables were expressed as mean ± SD and categorical variables as frequencies (%).~Continuous variables were analysed individually using student's independent sample t-tests. Categorical variables were assessed using separate Fisher's exact (Chi-square) test."||||<0.05
72618548|NCT01026038|144768104|SUPERIORITY_OR_OTHER|||||||0.443||95.0|||||Fisher Exact|||Swelling (Mild): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/7vPnC/13vPnC.||||0.443
72504917|NCT01272180|144540895|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The immune response of ABCWY+OMV group was considered to be non-inferior to that of ACWY group if the lower limit of the two-sided 95% confidence interval on the difference between MenABCWY and MenACWY groups in percentage of subjects with seroresponse is greater than -10% for each of A, C, W-135and Y serogroups, at 30 days after the last vaccination.|Group Difference % (ABCWY+OMV - ACWY)|32.0|||||TWO_SIDED|95.0|21.0|44.0||||||Non-inferiority of seroresponse against N.meningitidis serogroup C of two doses of ABCWY+OMV combination vaccine to that of one dose of MenACWY vaccine.||44|21|
72618549|NCT01026038|144768104|SUPERIORITY_OR_OTHER|||||||0.261||95.0|||||Fisher Exact|||Swelling (Mild): Fisher exact test, 2-sided was used. Pairwise comparison was made between 7vPnC/7vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.||||0.261
72379939|NCT02376283|144268324|OTHER|Comparison of means between groups was assessed using analysis of variance (ANOVA) technique. ANOVA allowed for a comparison of more than two means and enabled an assessment to be made of the relationship between, different drugs (clopidogrel vs prasugrel vs ticagrelor), different clinical states (STEMI vs NSTEMI/UA) and different time points.|||||=|0.81||||||STEMI- clopidogrel vs prasugrel vs ticagrelor|ANOVA|ANOVA F(3,17) = 0.321||"Continuous variables were expressed as mean ± SD and categorical variables as frequencies (%).~Continuous variables were analysed individually using student's independent sample t-tests. Categorical variables were assessed using separate Fisher's exact (Chi-square) test."||||=0.810
72379940|NCT02376283|144268324|OTHER|Comparison of means between groups was assessed using analysis of variance (ANOVA) technique. ANOVA allowed for a comparison of more than two means and enabled an assessment to be made of the relationship between, different drugs (clopidogrel vs prasugrel vs ticagrelor), different clinical states (STEMI vs NSTEMI/UA) and different time points.|||||<|0.0001||||||NSTEMI- clopi vs pras vs tic|ANOVA|ANOVA F(2,25) = 14.103||"Continuous variables were expressed as mean ± SD and categorical variables as frequencies (%).~Continuous variables were analysed individually using student's independent sample t-tests. Categorical variables were assessed using separate Fisher's exact (Chi-square) test."||||< 0.0001
72379941|NCT05080660|144268344|SUPERIORITY||Posterior Mean Difference|0.23|||||TWO_SIDED|95.0|-0.26|0.73|||||Posterior mean difference with 95% credible interval is reported.|||0.73|-0.26|
72379942|NCT05080660|144268345|SUPERIORITY||Posterior Mean Difference|0.19|||||TWO_SIDED|95.0|-0.39|0.76|||||Posterior mean difference with 95% credible interval is reported.|||0.76|-0.39|
72379943|NCT05080660|144268346|SUPERIORITY||Posterior Mean Difference|0.62|||||TWO_SIDED|95.0|-0.23|1.47|||||Posterior mean difference with 95% credible interval is reported.|||1.47|-0.23|
72379944|NCT05080660|144268347|SUPERIORITY||Posterior Mean Difference|0.34|||||TWO_SIDED|95.0|-0.67|1.34|||||Posterior mean difference with 95% credible interval is reported.|||1.34|-0.67|
72379945|NCT05080660|144268348|SUPERIORITY||Posterior Mean Difference|0.08|||||TWO_SIDED|95.0|-0.35|0.5|||||Posterior mean difference with 95% credible interval is reported.|||0.50|-0.35|
72379946|NCT05080660|144268349|SUPERIORITY||Posterior Mean Difference|0.1|||||TWO_SIDED|95.0|-0.35|0.55|||||Posterior mean difference with 95% credible interval is reported.|||0.55|-0.35|
72379947|NCT05080660|144268350|SUPERIORITY||Posterior Mean Difference|1.98|||||TWO_SIDED|95.0|-0.88|4.88|||||Posterior mean difference with 95% credible interval is reported.|||4.88|-0.88|
72556351|NCT01492439|144644020|SUPERIORITY_OR_OTHER|||||||0.747||||||This applies to the 'negative' subscale of the PANSS.|ANCOVA|||||||0.747
72379948|NCT05080660|144268351|SUPERIORITY||Posterior Mean Difference|3.05|||||TWO_SIDED|95.0|-0.29|6.38|||||Posterior mean difference with 95% credible interval is reported.|||6.38|-0.29|
72556352|NCT01492439|144644020|SUPERIORITY_OR_OTHER|||||||0.582||||||This applies to the 'general psychopathology' subscale of the PANSS.|ANCOVA|||||||0.582
72379949|NCT05080660|144268352|SUPERIORITY||Posterior Mean Difference|0.13|||||TWO_SIDED|95.0|-0.23|0.5|||||Posterior mean difference with 95% credible interval is reported.|||0.50|-0.23|
72379950|NCT05080660|144268353|SUPERIORITY||Posterior Mean Difference|-0.01|||||TWO_SIDED|95.0|-0.39|0.37|||||Posterior mean difference with 95% credible interval is reported.|||0.37|-0.39|
72379951|NCT05080660|144268354|SUPERIORITY||Posterior Mean Difference|0.3|||||TWO_SIDED|95.0|-0.21|0.81|||||Posterior mean difference with 95% credible interval is reported.|||0.81|-0.21|
72379952|NCT05080660|144268355|SUPERIORITY||Posterior Mean Difference|0.29|||||TWO_SIDED|95.0|-0.31|0.9|||||Posterior mean difference with 95% credible interval is reported.|||0.90|-0.31|
72379953|NCT05080660|144268356|SUPERIORITY||Posterior Mean Difference|6.14|||||TWO_SIDED|95.0|-0.24|12.52|||||Posterior mean difference with 95% credible interval is reported.|||12.52|-0.24|
72379954|NCT05080660|144268357|SUPERIORITY||Posterior Mean Difference|5.15|||||TWO_SIDED|95.0|-1.9|12.18|||||Posterior mean difference with 95% credible interval is reported.|||12.18|-1.90|
72379955|NCT05080660|144268358|SUPERIORITY||Posterior Mean Difference|-0.02|||||TWO_SIDED|95.0|-0.32|0.27|||||Posterior mean difference with 95% credible interval is reported.|||0.27|-0.32|
72379956|NCT05080660|144268359|SUPERIORITY||Posterior Mean Difference|-0.2|||||TWO_SIDED|95.0|-0.52|0.13|||||Posterior mean difference with 95% credible interval is reported.|||0.13|-0.52|
72379957|NCT05080660|144268360|SUPERIORITY||Posterior Mean Difference|98.35|||||TWO_SIDED|95.0|-51.95|250.88|||||Posterior mean difference with 95% credible interval is reported.|||250.88|-51.95|
72379958|NCT05080660|144268361|SUPERIORITY||Posterior Mean Difference|123.36|||||TWO_SIDED|95.0|-46.51|293.69|||||Posterior mean difference with 95% credible interval is reported.|||293.69|-46.51|
72379959|NCT05080660|144268362|SUPERIORITY||Posterior Mean Difference|-0.01|||||TWO_SIDED|95.0|-0.06|0.05|||||Posterior mean difference with 95% credible interval is reported.|||0.05|-0.06|
72379960|NCT05080660|144268363|SUPERIORITY||Posterior Mean Difference|0.0|||||TWO_SIDED|95.0|-0.07|0.07|||||Posterior mean difference with 95% credible interval is reported.|||0.07|-0.07|
72379961|NCT04533685|144268364|SUPERIORITY||Adjusted Risk Ratio|1.01|||||TWO_SIDED|95.0|1.0|1.02|||||Adjusted risk ratio. These results compare arms which received reminder letters to the arm receiving no reminder letter (control)|Comparing the risk of receiving an influenza vaccination||1.02|1.00|
72379962|NCT04533685|144268364|SUPERIORITY||Adjusted Risk Ratio|1.0|||||TWO_SIDED|95.0|0.98|1.01|||||These results compare arms which received direct appointment scheduling to the arms not receiving direct appointment scheduling.|Comparing the risk of receiving an influenza vaccination||1.01|0.98|
72556353|NCT01492439|144644021|SUPERIORITY_OR_OTHER|||||||0|||||||ANCOVA|||||||0.000
72556354|NCT01492439|144644022|SUPERIORITY_OR_OTHER|||||||0.95||||||This applies to the 'positive' subscale of the PANSS.|ANCOVA|||||||0.950
72556355|NCT01492439|144644022|SUPERIORITY_OR_OTHER|||||||0.027||||||This applies to the 'negative' subscale of the PANSS.|ANCOVA|||||||0.027
72556356|NCT01492439|144644022|SUPERIORITY_OR_OTHER|||||||0.639||||||This applies to the 'general psychopathology' subscale of the PANSS.|ANCOVA|||||||0.639
72556357|NCT01492439|144644023|SUPERIORITY_OR_OTHER|||||||0.008|||||||ANCOVA|||||||0.008
72556358|NCT01492439|144644024|SUPERIORITY_OR_OTHER|||||||0.314||||||This applies to Trial 1 on the CVLT.|ANCOVA|||||||0.314
72556359|NCT01492439|144644024|SUPERIORITY_OR_OTHER|||||||0.242||||||This applies to the total score of trials 1-4 (total free recall) of the CVLT.|ANCOVA|||||||0.242
72556360|NCT01492439|144644024|SUPERIORITY_OR_OTHER|||||||0.669||||||This applies to the 'long delay free recall' subtest of the CVLT.|ANCOVA|||||||0.669
72556361|NCT01492439|144644025|SUPERIORITY_OR_OTHER|||||||0.139||||||This applies to the 'trial 1' subtest of the CVLT.|ANCOVA|||||||0.139
72379963|NCT04533685|144268364|SUPERIORITY||Adjusted Risk Ratio|1.0|||||TWO_SIDED|95.0|1.0|1.01|||||These results compare arms which received pre-commitment reminders to the arms not receiving pre-commitment reminders.|Comparing the risk of receiving an influenza vaccination||1.01|1.00|
72556362|NCT01492439|144644025|SUPERIORITY_OR_OTHER|||||||0.269||||||This applies to the total of trials 1-4 (total free recall) of the CVLT.|ANCOVA|||||||0.269
72618550|NCT01026038|144768104|SUPERIORITY_OR_OTHER|||||||0.687||95.0|||||Fisher Exact|||Swelling (Mild): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.||||0.687
72379964|NCT04533685|144268364|SUPERIORITY||Adjusted Risk Ratio|1.0|||||TWO_SIDED|95.0|0.99|1.01|||||These results compare arms which received pre-appointment reminder to the arms not receiving pre-appointment reminder.|Comparing the risk of receiving an influenza vaccination||1.01|0.99|
72379965|NCT04221230|144268365|OTHER||Least square mean difference|-1.7|STANDARD_ERROR_OF_MEAN|1.08||0.121|TWO_SIDED|95.0|-3.8|0.4|||Mixed Model Repeated Measures|||||0.4|-3.8|0.121
72379966|NCT03687970|144268384|OTHER|Multivariable logistic regression was applied to predict binary outcome while controlling for other potential confounding factors (age, cumulative chemotherapy dose, chemotherapy group).|Slope|-0.13||||0.05|TWO_SIDED|||||threshold for p value is 0.05.|Regression, Logistic|||||||0.05
72379967|NCT03687970|144268385|OTHER|Spearman correlation coefficient between the Aδ:C fiber detection threshold ratio and the severity of painful CIPN on NPSI scale for patients with painful CIPN was calculated.|rho coefficient|0.22||||0.7525|TWO_SIDED|||||The thrshold for p value is 0.05.|Spearman's correlation coefficient|||||||0.7525
72379968|NCT03687970|144268385|OTHER|Spearman correlation coefficient between the Aδ:C fiber detection threshold ratio and the severity of painful CIPN on NPSI scale for Control group patients without painful CIPN was calculated.|rho coefficient|0.32||||0.1876|TWO_SIDED|||||The threshold for p value is 0.05.|Spearman's correlation coefficien|||||||0.1876
72379969|NCT03687970|144268385|OTHER|Spearman correlation coefficient between the Aδ:C fiber pain threshold ratio and the severity of painful CIPN on NPSI scale for patients with painful CIPN was calculated.|rho coefficient|0.13||||0.61|TWO_SIDED|||||The threshold for p value is 0.05.|Spearman's correlation coefficient|||||||0.61
72379970|NCT03687970|144268385|OTHER|Spearman correlation coefficient between the Aδ:C fiber detection threshold ratio and the severity of painful CIPN on NPSI scale for patients with painful CIPN was calculated.|rho coefficient|-0.2812205||||0.2914|TWO_SIDED|||||The threshold for p value is 0.05.|Spearman's correlation coefficient|||||||0.2914
72379971|NCT03070444|144268387|OTHER|GEE analysis|GEE analysis|0.99||||0.0002|TWO_SIDED|95.0|0.48|1.51|||GEE analysis|||||1.51|0.48|0.0002
72379972|NCT03070444|144268388|OTHER|Mann-Whitney U test||||||0.55|||||||Wilcoxon (Mann-Whitney)|||||||0.55
72433624|NCT00991276|144380376|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-3.07|STANDARD_ERROR_OF_MEAN|1.01||0.0029|TWO_SIDED|95.0|-5.07|-1.07||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||-1.07|-5.07|0.0029
72379973|NCT01373489|144268389|SUPERIORITY||Mean Difference (Final Values)|10.0|||<|0.05|TWO_SIDED|95.0|||||ANCOVA|||||||<0.05
72379974|NCT02582255|144268395|OTHER|||||||0.05|||||||Clopper-Pearson|||||||0.05
72379975|NCT02582255|144268396|OTHER|||||||0.025|||||||Clopper-Pearson|||||||0.025
72379976|NCT02582255|144268397|OTHER|||||||0.025|||||||Clopper-Pearson|||||||0.025
72379977|NCT02582255|144268398|OTHER|||||||0.05|||||||Clopper-Pearson|||||||0.05
72379978|NCT02417844|144268402|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence range of 80% to 125%.|Geometric mean ratio (%)|99.66|STANDARD_DEVIATION|19.15|||TWO_SIDED|90.0|92.19|107.74|||||"The standard deviation in the statistical analysis is actually the intra-individual coefficient of variation.~Ratio calculated as test divided by reference."|||107.74|92.19|
72379979|NCT02417844|144268403|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence range of 80% to 125%.|Geometric mean ratio (%)|99.58|STANDARD_DEVIATION|13.51|||TWO_SIDED|90.0|94.23|105.24|||||"The standard deviation in the statistical analysis is actually the intra-individual coefficient of variation.~Ratio calculated as test divided by reference."|||105.24|94.23|
72379980|NCT02417844|144268404|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence range of 80% to 125%.|Geometric mean ratio (%)|99.48|STANDARD_DEVIATION|14.12|||TWO_SIDED|90.0|93.9|105.39|||||"The standard deviation in the statistical analysis is actually the intra-individual coefficient of variation.~Ratio calculated as test divided by reference."|||105.39|93.90|
72379981|NCT01155219|144268411|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Fisher Exact|||||||< 0.001
72379982|NCT03614975|144268441|OTHER|||||||0.28||||||A/H1N1|Chi-squared|||||||0.28
72379983|NCT03614975|144268441|OTHER|||||||0.64||||||A/H3N2|Chi-squared|||||||0.64
72379984|NCT03614975|144268441|OTHER|||||||0.64||||||B/Colorado|Chi-squared|||||||0.64
72379985|NCT03614975|144268441|OTHER|||||||0.23||||||B/Phuket|Chi-squared|||||||0.23
72379986|NCT03614975|144268442|OTHER|||||||0.42||||||Vaccine Strain: A/H1N1:Day 0|Chi-squared|||||||0.42
72379987|NCT03614975|144268442|OTHER|||||||0.16||||||Vaccine Strain: A/H1N1: Day 21|Chi-squared|||||||0.16
72556363|NCT01492439|144644025|SUPERIORITY_OR_OTHER|||||||0.666||||||This applies to the 'long delay free recall' subtest of the CVLT.|ANCOVA|||||||0.666
72556364|NCT01492439|144644026|SUPERIORITY_OR_OTHER|||||||0.391|||||||ANCOVA|||||||0.391
72556365|NCT01492439|144644027|SUPERIORITY_OR_OTHER|||||||0.958|||||||ANCOVA|||||||0.958
72618551|NCT01026038|144768104|SUPERIORITY_OR_OTHER|||||||0.671||95.0|||||Fisher Exact|||Swelling (Moderate): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/7vPnC/13vPnC.||||0.671
72379988|NCT03614975|144268442|OTHER|||||||0.42||||||Vaccine Strain: A/H3N2: Day 0|Chi-squared|||||||0.42
72379989|NCT03614975|144268442|OTHER|||||||0.94||||||Vaccine Strain: A/H3N2: Day 21|Chi-squared|||||||0.94
72379990|NCT03614975|144268442|OTHER|||||||0.87||||||Vaccine Strain: B/Colorado :Day 0|Chi-squared|||||||0.87
72379991|NCT03614975|144268442|OTHER|||||||0.77||||||Vaccine Strain: B/Colorado : Day 21|Chi-squared|||||||0.77
72556366|NCT01492439|144644028|SUPERIORITY_OR_OTHER|||||||0.754||||||This applies to the 'forward' sequence of the Digit Span Test.|ANCOVA|||||||0.754
72556367|NCT01492439|144644028|SUPERIORITY_OR_OTHER|||||||0.518||||||This applies to the 'backward' sequence of the Digit Span Test.|ANCOVA|||||||0.518
72379992|NCT03614975|144268442|OTHER|||||||0.33||||||Vaccine Strain: B/Phuket: Day 0|Chi-squared|||||||0.33
72379993|NCT03614975|144268442|OTHER|||||||0.21||||||Vaccine Strain: B/Phuket: Day 21|Chi-squared|||||||0.21
72379994|NCT03614975|144268443|OTHER|||||||0.49||||||Vaccine Strain: A/H1N1: Day 0|Kruskal-Wallis|||||||0.49
72379995|NCT03614975|144268443|OTHER|||||||0.23||||||Vaccine Strain: A/H1N1: Day 21|Kruskal-Wallis|||||||0.23
72379996|NCT03614975|144268443|OTHER|||||||0.1||||||Vaccine Strain: A/H3N2: Day 0|Kruskal-Wallis|||||||0.10
72379997|NCT03614975|144268443|OTHER|||||||0.86||||||Vaccine Strain: A/H3N2: Day 21|Kruskal-Wallis|||||||0.86
72379998|NCT03614975|144268443|OTHER|||||||0.73||||||Vaccine Strain: B/Colorado: Day 0|Kruskal-Wallis|||||||0.73
72379999|NCT03614975|144268443|OTHER|||||||0.67||||||Vaccine Strain: B/Colorado: Day 21|Kruskal-Wallis|||||||0.67
72380000|NCT03614975|144268443|OTHER|||||||0.36||||||Vaccine Strain: B/Phuket: Day 0|Kruskal-Wallis|||||||0.36
72618552|NCT01026038|144768104|SUPERIORITY_OR_OTHER|||||||0.253||95.0|||||Fisher Exact|||Swelling (Moderate): Fisher exact test, 2-sided was used. Pairwise comparison was made between 7vPnC/7vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.||||0.253
72380001|NCT03614975|144268443|OTHER|||||||0.65||||||Vaccine Strain: B/Phuket: Day 21|Kruskal-Wallis|||||||0.65
72380002|NCT01569464|144268450|SUPERIORITY_OR_OTHER||LS Mean|-0.27|STANDARD_ERROR_OF_MEAN|1.36||0.8451|TWO_SIDED|95.0|-2.96|2.42||A hierarchical test procedure was done for the primary efficacy variables at an α-level of 5 %. If a test was statistically significant, a test for the next variable was performed. If a test was not statistically significant the procedure stopped.|ANCOVA|||ANCOVA model was used for analysis with fixed effects for treatment assignment (main factor) and the subject's investigational center (stratifying factor) and a covariate for the Baseline Visit value of the IRLS sum score.||2.42|-2.96|0.8451
72380003|NCT01569464|144268451|SUPERIORITY_OR_OTHER||LS Mean|0.07|STANDARD_ERROR_OF_MEAN|0.34||0.8336|TWO_SIDED|95.0|-0.61|0.75||A hierarchical test procedure was done for the primary efficacy variables at an α-level of 5 %. If a test was statistically significant, a test for the next variable was performed. If a test was not statistically significant the procedure stopped.|ANCOVA|||ANCOVA model was used for analysis with fixed effects for treatment assignment (main factor) and the subject's investigational center (stratifying factor) and a covariate for the Baseline Visit value of the IRLS sum score.||0.75|-0.61|0.8336
72380004|NCT01390220|144268472|SUPERIORITY|||||||0.0109|||||||Fisher Exact|2-sided||||||0.0109
72380005|NCT01390220|144268473|SUPERIORITY|||||||0.0043|||||||Fisher Exact|2-sided||||||0.0043
72380006|NCT01390220|144268474|SUPERIORITY|||||||0.0124|||||||Log Rank|||||||0.0124
72380007|NCT01390220|144268475|SUPERIORITY|||||||0.0124|||||||Log Rank|||Kaplan-Meier estimates.||||0.0124
72380008|NCT01856023|144268493|SUPERIORITY|one -sample binomial test - 1-year estimated OS for these 28 patients was 75% (95%CI: 51%, 88%)||||||0.001||||||compared to the historical control rate of 46% one year survival|Log Rank|||OS rates of the Evaluable population in entire cohort was compared with the historical control rate of 46% (Hodi, et al NEJM 2010) using a one-sample binomial test due to early termination of enrollment without reaching target accrual; planned analysis to be the difference between treatment arms using log-rank test. One year OS along with 95% CI estimated for entire population and each treatment arm separately.||||.001
72380009|NCT04718103|144268499|SUPERIORITY|Analysis performed using a generalized linear model assuming a negative binomial distribution and covariates of treatment group, baseline ICS dose (medium or high), exacerbation history (2, 3, 4+), geographical region and baseline pre-bronchodilator percent predicted Forced Expiratory Volume in one second (FEV1) and offset of log (total time in the study in years).|Rate Ratio|0.52|||<|0.001|TWO_SIDED|95.0|0.36|0.73|||Negative Binomial Distribution|||To demonstrate the superiority of GSK3511294 100 mg SC + SoC following two doses (at Week 0 and at Week 26) compared with placebo + SoC, assessed by the annualized rate of clinically significant exacerbations measured over the study intervention period of 52 weeks.||0.73|0.36|<0.001
72505042|NCT01380093|144541430|SUPERIORITY_OR_OTHER||LS Mean Difference|11.9||||0.0009|TWO_SIDED|95.0|5.1|18.6||p-value adjusted for multiple comparisons with Hochberg adjustment.|Mixed Models Analysis|||LS mean and 95% CI were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||18.6|5.1|0.0009
72618553|NCT01026038|144768104|SUPERIORITY_OR_OTHER|||||||0.074||95.0|||||Fisher Exact|||Swelling (Moderate): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.||||0.074
72380010|NCT04718103|144268500|SUPERIORITY||Least-square (LS) means|-2.31||||0.2|TWO_SIDED|95.0|-5.84|1.23|||Mixed Models Repeated Measures (MMRM)|||To demonstrate the superiority of GSK3511294 100 mg SC + SoC following two doses (at Week 0 and at Week 26) compared with placebo + SoC, assessed by SGRQ Total Score measured over the study intervention period of 52 weeks.||1.23|-5.84|0.200
72380011|NCT04718103|144268501|SUPERIORITY||Difference in Least-Square Mean|-0.11||||0.333|TWO_SIDED|95.0|-0.33|0.11|||Mixed Models Repeated Measures (MMRM)|||Analysis performed using a repeated measures model with covariates of treatment group, baseline ICS dose (medium or high), exacerbation history (2, 3, 4+), geographical region, baseline ACQ-5 score, baseline pre-bronchodilator percent predicted FEV1, visit, visit by baseline ACQ-5 score and visit by treatment group.||0.11|-0.33|0.333
72380012|NCT04718103|144268502|SUPERIORITY||Difference in Least-Square Means|0.056||||0.267|TWO_SIDED|95.0|-0.043|0.154|||Mixed Models Repeated Measures (MMRM)|||Analysis performed using a repeated measures model with covariates of treatment group, baseline ICS dose (medium or high), exacerbation history (2, 3, 4+), geographical region, baseline pre-bronchodilator FEV1, visit, visit by baseline pre-bronchodilator FEV1 and visit by treatment group.||0.154|-0.043|0.267
72380013|NCT04718103|144268503|SUPERIORITY||Difference in Least square means|-0.21||||0.173|TWO_SIDED|95.0|-0.52|0.09|||Mixed Models Repeated Measures (MMRM)|||Analysis performed using a repeated measures model with covariates of treatment group, baseline ICS dose (medium or high), exacerbation history (2, 3, 4+), geographical region, baseline ANSD weekly mean score, baseline pre-bronchodilator percent predicted FEV1, visit, visit by baseline ANSD weekly mean score and visit by treatment group.||0.09|-0.52|0.173
72380014|NCT04718103|144268504|SUPERIORITY||Difference in Least square means|-0.21||||0.138|TWO_SIDED|95.0|-0.48|0.07|||Mixed Models Repeated Measures (MMRM)|||Analysis performed using a repeated measures model with covariates of treatment group, baseline ICS dose (medium or high), exacerbation history (2, 3, 4+), geographical region, baseline ADSD weekly mean score, baseline pre-bronchodilator percent predicted FEV1, visit, visit by baseline ADSD weekly mean score and visit by treatment group.||0.07|-0.48|0.138
72618554|NCT01026038|144768104|SUPERIORITY_OR_OTHER|||||||0.323||95.0|||||Fisher Exact|||Swelling (Severe): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/7vPnC/13vPnC.||||0.323
72380015|NCT04718103|144268505|SUPERIORITY|Analysis performed using a generalized linear model assuming a negative binomial distribution and covariates of treatment group, baseline ICS dose (medium or high), exacerbation history (2, 3, 4+), geographical region and baseline pre-bronchodilator percent predicted FEV1.|Rate Ratio|0.42||||0.087|TWO_SIDED|95.0|0.16|1.13|||Negative binomial distribution|||||1.13|0.16|0.087
72380016|NCT00322153|144268506|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.6||||0.001|TWO_SIDED|95.0|1.0|4.2|||ANCOVA|Least-squares mean (-0.4 in placebo and 2.2 in memantine ER) are controlled for center and adjusted for SIB baseline value.||The co-primary efficacy parameter was change from Baseline to Week 24 in SIB total score. Missing SIB total scores at Week 24 were imputed using the last-observation-carried-forward (LOCF) approach.||4.2|1.0|0.001
72380017|NCT00322153|144268507|SUPERIORITY_OR_OTHER|||||||0.008|||||||Cochran-Mantel-Haenszel|||The co-primary efficacy parameter was CIBIC-Plus total score at week 24. Missing CIBIC-Plus total scores at Week 24 were imputed using the last-observation-carried-forward (LOCF) approach.||||0.008
72380018|NCT00322153|144268508|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.7||||0.177|TWO_SIDED|95.0|-0.3|1.8|||ANCOVA|Least-squares mean (-1.7 in placebo and -1.0 in memantine ER) are controlled for center and adjusted for ADCS-ADL19 baseline value.||The secondary efficacy parameter was change from Baseline at Week 24 in the total score of the 19-Item Alzheimer's Disease Cooperative Study-Activities of Daily Living Inventory (ADCS-ADL19). Missing scores at week 24 were imputed using the last-observation-carried-forward (LOCF) approach.||1.8|-0.3|0.177
72380019|NCT00136604|144268509|NON_INFERIORITY|Criterion for non-inferiority evaluation: The lower limit (LL) of the standardized asymptotic 95% confidence interval (CI) on the difference in the percentage of subjects with SBA-MenC titre ≥ 1:128 between the Tritanrix-Hepb/Hib-MenAC-TT Group and (minus) the TRITANRIX-HEPB+Mencevax + Meningitec control group was above -10%.|Difference in percentage of subjects|0.0|||||TWO_SIDED|95.0|-1.53|3.05||||||Demonstration of non-inferiority of a fourth dose of the Tritanrix-HepB/Hib-MenAC-TT vaccine versus a fourth dose of the Tritanrix-HepB/Hiberix and Meningitec vaccine given concomitantly in terms of the percentage of subjects with an SBA-MenC titre ≥ 1:128.||3.05|-1.53|
72380020|NCT00136604|144268511|NON_INFERIORITY|Criterion for non-inferiority evaluation: The lower limit (LL) of the standardized asymptotic 95% CI on the difference in seroprotection (anti-PRP concentration ≥ 1.0 µg/mL) between the Tritanrix-Hepb/Hib-MenAC-TT Group and (minus) the Tritanrix-Hepb/Mencevax+Tritanrix-HepB/Hiberix Group was above -10%.|Difference in seroprotection rate|0.0|||||TWO_SIDED|95.0|-1.53|3.05||||||Demonstration of non-inferiority of the Tritanrix-HepB/Hib-MenAC-TT vaccine versus the Tritanrix-HepB/Hiberix vaccine when used as a booster vaccine in Tritanrix-HepB/Hib-MenAC-TT primed subjects in terms of the percentage of subjects with an anti-PRP concentration ≥ 1.0 µg/mL.||3.05|-1.53|
72380021|NCT00591578|144268551|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.64|||<|0.001|TWO_SIDED|95.0|-5.59|-1.69||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value presented. Overall 0.05 level of significance for multiple comparisons controlled using stepwise testing procedure.|ANCOVA|||||-1.69|-5.59|<0.001
72380022|NCT00591578|144268551|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.03|||<|0.001|TWO_SIDED|95.0|-6.01|-2.06||Unadjusted p-value presented. Overall 0.05 level of significance for multiple comparisons controlled using stepwise testing procedure.|ANCOVA|||||-2.06|-6.01|<0.001
72380023|NCT00591578|144268552|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.27||||0.015|TWO_SIDED|95.0|-5.9|-0.63||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). The unadjusted p-value is presented.|ANCOVA|||||-0.63|-5.90|0.015
72380024|NCT00591578|144268552|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.34|||<|0.001|TWO_SIDED|95.0|-8.0|-2.68||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). The unadjusted p-value is presented.|ANCOVA|||||-2.68|-8.00|<0.001
72380025|NCT00591578|144268553|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.16|||<|0.001|TWO_SIDED|95.0|-3.44|-0.88||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). The unadjusted p-value is presented.|ANCOVA|||||-0.88|-3.44|<0.001
72380026|NCT00591578|144268553|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.69|||<|0.001|TWO_SIDED|95.0|-3.99|-1.4||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). The unadjusted p-value is presented.|ANCOVA|||||-1.40|-3.99|<0.001
72380027|NCT00591578|144268554|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.52||||0.001|TWO_SIDED|95.0|-4.06|-0.98||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). The unadjusted p-value is presented.|ANCOVA|||||-0.98|-4.06|0.001
72380028|NCT00591578|144268554|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.76|||<|0.001|TWO_SIDED|95.0|-4.32|-1.21||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). The unadjusted p-value is presented.|ANCOVA|||||-1.21|-4.32|<0.001
72433625|NCT00991276|144380376|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-3.03|STANDARD_ERROR_OF_MEAN|1.01||0.0032|TWO_SIDED|95.0|-5.02|-1.04||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||-1.04|-5.02|0.0032
72618555|NCT01026038|144768104|SUPERIORITY_OR_OTHER|||||||0.489||95.0|||||Fisher Exact|||Swelling (Severe): Fisher exact test, 2-sided was used. Pairwise comparison was made between 7vPnC/7vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.||||0.489
72505043|NCT01380093|144541430|SUPERIORITY_OR_OTHER||LS Mean Difference|36.8|||<|0.0001|TWO_SIDED|95.0|30.0|43.6||p-value adjusted for multiple comparisons with Hochberg adjustment.|Mixed Models Analysis|||LS mean and 95% CI were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||43.6|30.0|<0.0001
72618556|NCT01026038|144768104|SUPERIORITY_OR_OTHER|||||||0.607||95.0|||||Fisher Exact|||Redness (Any): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/7vPnC/13vPnC.||||0.607
72380029|NCT00591578|144268555|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.49|||<|0.001|TWO_SIDED|95.0|-5.53|-1.44||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). The unadjusted p-value is presented.|ANCOVA|||||-1.44|-5.53|<0.001
72380030|NCT00591578|144268555|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.9|||<|0.001|TWO_SIDED|95.0|-5.96|-1.83||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). The unadjusted p-value is presented.|ANCOVA|||||-1.83|-5.96|<0.001
72380031|NCT00591578|144268556|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.17||||0.002|TWO_SIDED|95.0|-3.54|-0.79||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). The unadjusted p-value is presented.|ANCOVA|||||-0.79|-3.54|0.002
72380032|NCT00591578|144268556|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.67|||<|0.001|TWO_SIDED|95.0|-4.06|-1.28||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). The unadjusted p-value is presented.|ANCOVA|||||-1.28|-4.06|<0.001
72380033|NCT00591578|144268557|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.79|||<|0.001|TWO_SIDED|95.0|-5.96|-1.62||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). The unadjusted p-value is presented.|ANCOVA|||||-1.62|-5.96|<0.001
72380034|NCT00591578|144268557|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.44|||<|0.001|TWO_SIDED|95.0|-6.63|-2.24||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). The unadjusted p-value is presented.|ANCOVA|||||-2.24|-6.63|<0.001
72380035|NCT00591578|144268558|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.0||||0.008|TWO_SIDED|95.0|-3.48|-0.53||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). The unadjusted p-value is presented.|ANCOVA|||||-0.53|-3.48|0.008
72380036|NCT00591578|144268558|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.84|||<|0.001|TWO_SIDED|95.0|-4.33|-1.35||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). The unadjusted p-value is presented.|ANCOVA|||||-1.35|-4.33|<0.001
72380037|NCT00591578|144268559|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.44||||0.002|TWO_SIDED|95.0|-5.57|-1.3||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). The unadjusted p-value is presented.|ANCOVA|||||-1.30|-5.57|0.002
72380038|NCT00591578|144268559|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.01|||<|0.001|TWO_SIDED|95.0|-6.16|-1.85||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). The unadjusted p-value is presented.|ANCOVA|||||-1.85|-6.16|<0.001
72380039|NCT00591578|144268560|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.18||||0.003|TWO_SIDED|95.0|-3.63|-0.72||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). The unadjusted p-value is presented.|ANCOVA|||||-0.72|-3.63|0.003
72380040|NCT00591578|144268560|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.73|||<|0.001|TWO_SIDED|95.0|-4.2|-1.25||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). The unadjusted p-value is presented.|ANCOVA|||||-1.25|-4.20|<0.001
72380041|NCT00591578|144268561|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.38||||0.005|TWO_SIDED|95.0|-5.76|-1.0||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). The unadjusted p-value is presented.|ANCOVA|||||-1.00|-5.76|0.005
72380042|NCT00591578|144268561|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.47||||0.005|TWO_SIDED|95.0|-5.87|-1.06||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). The unadjusted p-value is presented.|ANCOVA|||||-1.06|-5.87|0.005
72380043|NCT00591578|144268562|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.31||||0.009|TWO_SIDED|95.0|-4.04|-0.59||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). The unadjusted p-value is presented.|ANCOVA|||||-0.59|-4.04|0.009
72380044|NCT00591578|144268562|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.59||||0.004|TWO_SIDED|95.0|-4.34|-0.84||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). The unadjusted p-value is presented.|ANCOVA|||||-0.84|-4.34|0.004
72380045|NCT00591578|144268563|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.46||||0.016|TWO_SIDED|95.0|1.07|2.0||P-value for response criteria for systolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value is presented.|Regression, Logistic|Includes only those participants with a baseline and at least one post-baseline value.||||2.00|1.07|0.016
72380046|NCT00591578|144268563|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.63||||0.002|TWO_SIDED|95.0|1.19|2.23||P-value for response criteria for systolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value is presented.|Regression, Logistic|Includes only those participants with a baseline and at least one post-baseline value.||||2.23|1.19|0.002
72380047|NCT00591578|144268564|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.46||||0.041|TWO_SIDED|95.0|1.02|2.1||P-value for response criteria for diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic diastolic blood pressure as a covariate. The unadjusted p-value is presented.|Regression, Logistic|Includes only those participants with a baseline and at least one post-baseline value.||||2.10|1.02|0.041
72380048|NCT00591578|144268564|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.58||||0.015|TWO_SIDED|95.0|1.09|2.28||P-value for response criteria for diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic diastolic blood pressure as a covariate. The unadjusted p-value is presented.|Regression, Logistic|Includes only those participants with a baseline and at least one post-baseline value.||||2.28|1.09|0.015
72380049|NCT00591578|144268565|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.46||||0.018|TWO_SIDED|95.0|1.07|1.99||P-value for joint response criteria for systolic blood pressure and diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value is presented.|Regression, Logistic|Includes only those participants with a baseline and at least one post-baseline value.||||1.99|1.07|0.018
72556368|NCT01492439|144644028|SUPERIORITY_OR_OTHER|||||||0.531||||||This applies to the total score (forward+backwards) on the Digit Span Test.|ANCOVA|||||||0.531
72380050|NCT00591578|144268565|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.7|||<|0.001|TWO_SIDED|95.0|1.24|2.33||P-value for joint response criteria for systolic blood pressure and diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value is presented.|Regression, Logistic|Includes only those participants with a baseline and at least one post-baseline value.||||2.33|1.24|<0.001
72380051|NCT05038904|144268682|SUPERIORITY|We estimated that 10 subjects allowed for 80% power to detect a 3-fold increase (1.1 natural log units; i.e. 1 food dose escalation) in the threshold food dose using a paired t test with p\<0.05. For this sample size determination, the primary endpoint was assumed to be normally distributed with a standard deviation of 1.1 natural log units.||||||0.002|||||||Wilcoxon (Mann-Whitney)|||||||0.002
72380052|NCT05038904|144268683|SUPERIORITY|||||||0.0014|||||||t-test, 2 sided|||||||0.0014
72380053|NCT05038904|144268684|SUPERIORITY|||||||0.002|||||||Wilcoxon (Mann-Whitney)|||||||0.002
72380054|NCT05038904|144268685|SUPERIORITY|||||||0.002|||||||Wilcoxon (Mann-Whitney)|||Participants' ex vivo basophil activation during acalabrutinib treatment was compared to their own baseline level.||||0.002
72380055|NCT02730208|144268772|OTHER|Treatment effect outcomes are estimates.|Least Squares (LS) Mean Difference|-1.48|||||TWO_SIDED|95.0|-7.47|4.52||||||||4.52|-7.47|
72380056|NCT00245219|144268774|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|TWO_SIDED||||||Regression, Linear|||The comparison between the peer support condition and the control condition at Time 2. The full regression model included 2 dummy coded variables, 1 contrasting the education and control condition, and 1 contrasting the peer support and control condition. The baseline measure of the outcome variable was included, in order to examine changes in the outcomes over time. This model tested the main effects of the conditions among patients with early stage cancer, late stage patients were excluded.||||>0.05
72380057|NCT00245219|144268774|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|TWO_SIDED||||||Regression, Linear|||The comparison between the education condition and the control condition at Time 2. The full regression model included 2 dummy coded variables, 1 contrasting the education and control condition, and 1 contrasting the peer support and control condition. The baseline measure of the outcome variable was included, in order to examine changes in the outcomes over time. This model tested the main effects of the conditions among patients with early stage cancer, late stage patients were excluded.||||>0.05
72380058|NCT00245219|144268774|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|TWO_SIDED||||||Regression, Linear|||The comparison between the peer support condition and the control condition at Time 3. The full regression model included 2 dummy coded variables, 1 contrasting the education and control condition, and 1 contrasting the peer support and control condition. The baseline measure of the outcome variable was included, in order to examine changes in the outcomes over time. This model tested the main effects of the conditions among patients with early stage cancer, late stage patients were excluded.||||>0.05
72380059|NCT00245219|144268774|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|TWO_SIDED||||||Regression, Linear|||The comparison between the education condition and the control condition at Time 3. The full regression model included 2 dummy coded variables, 1 contrasting the education and control condition, and 1 contrasting the peer support and control condition. The baseline measure of the outcome variable was included, in order to examine changes in the outcomes over time. This model tested the main effects of the conditions among patients with early stage cancer, late stage patients were excluded.||||>0.05
72618557|NCT01026038|144768104|SUPERIORITY_OR_OTHER|||||||0.549||95.0|||||Fisher Exact|||Redness (Any): Fisher exact test, 2-sided was used. Pairwise comparison was made between 7vPnC/7vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.||||0.549
72380060|NCT00245219|144268774|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|TWO_SIDED||||||Regression, Linear|||The comparison between the peer support condition and control condition at Time 2, among both late and early stage patients. The full regression model consisted of 3 steps: The 1st step contained the baseline measure of the dependent variable. The 2nd step contained two dummy coded variables contrasting each condition with control. The 3rd step contained the interaction between the peer support condition and cancer stage. Patients in the education condition were excluded from this analysis.||||>0.05
72380061|NCT00245219|144268774|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|TWO_SIDED||||||Regression, Linear|||The comparison between the peer support condition and control condition at Time 3, among both late and early stage patients. The full regression model consisted of 3 steps: The 1st step contained the baseline measure of the dependent variable. The 2nd step contained two dummy coded variables contrasting each condition with control. The 3rd step contained the interaction between the peer support condition and cancer stage. Patients in the education condition were excluded from this analysis.||||>0.05
72556369|NCT01492439|144644029|SUPERIORITY_OR_OTHER|||||||0.802||||||This applies to the 'forward' sequence of the Digit Span Test.|ANCOVA|||||||0.802
72380062|NCT00245219|144268774|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|TWO_SIDED||||||Regression, Linear|||The interaction between the peer support condition and cancer stage at Time 2. The full regression model consisted of 3 steps: The 1st step contained the baseline measure of the dependent variable. The 2nd step contained two dummy coded variables contrasting each condition with control. The 3rd step contained the interaction between the peer support condition and cancer stage. Patients in the education condition were excluded from this analysis.||||>0.05
72380063|NCT00245219|144268774|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|TWO_SIDED||||||Regression, Linear|||The interaction between the peer support condition and cancer stage at Time 3. The full regression model consisted of 3 steps: The 1st step contained the baseline measure of the dependent variable. The 2nd step contained two dummy coded variables contrasting each condition with control. The 3rd step contained the interaction between the peer support condition and cancer stage. Patients in the education condition were excluded from this analysis.||||>0.05
72380064|NCT00245219|144268775|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|TWO_SIDED||||||Regression, Linear|||The comparison between the peer support condition and the control condition at Time 2. The full regression model included 2 dummy coded variables, 1 contrasting the education and control condition, and 1 contrasting the peer support and control condition. The baseline measure of the outcome variable was included, in order to examine changes in the outcomes over time. This model tested the main effects of the conditions among patients with early stage cancer, late stage patients were excluded.||||>0.05
72556370|NCT01492439|144644029|SUPERIORITY_OR_OTHER|||||||0.091||||||This applies to the 'backwards' sequence of the Digit Span Test.|ANCOVA|||||||0.091
72380065|NCT00245219|144268775|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|TWO_SIDED||||||Regression, Linear|||The comparison between the education condition and the control condition at Time 2. The full regression model included 2 dummy coded variables, 1 contrasting the education and control condition, and 1 contrasting the peer support and control condition. The baseline measure of the outcome variable was included, in order to examine changes in the outcomes over time. This model tested the main effects of the conditions among patients with early stage cancer, late stage patients were excluded.||||>0.05
72380066|NCT00245219|144268775|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|TWO_SIDED||||||Regression, Linear|||The comparison between the peer support condition and the control condition at Time 3. The full regression model included 2 dummy coded variables, 1 contrasting the education and control condition, and 1 contrasting the peer support and control condition. The baseline measure of the outcome variable was included, in order to examine changes in the outcomes over time. This model tested the main effects of the conditions among patients with early stage cancer, late stage patients were excluded.||||>0.05
72380067|NCT00245219|144268775|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|TWO_SIDED||||||Regression, Linear|||The comparison between the education condition and the control condition at Time 3. The full regression model included 2 dummy coded variables, 1 contrasting the education and control condition, and 1 contrasting the peer support and control condition. The baseline measure of the outcome variable was included, in order to examine changes in the outcomes over time. This model tested the main effects of the conditions among patients with early stage cancer, late stage patients were excluded.||||>0.05
72380068|NCT00245219|144268775|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|TWO_SIDED||||||Regression, Linear|||The comparison between the peer support condition and control condition at Time 2, among both late and early stage patients. The full regression model consisted of 3 steps: The 1st step contained the baseline measure of the dependent variable. The 2nd step contained two dummy coded variables contrasting each condition with control. The 3rd step contained the interaction between the peer support condition and cancer stage. Patients in the education condition were excluded from this analysis.||||>0.05
72380069|NCT00245219|144268775|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|TWO_SIDED||||||Regression, Linear|||The interaction between the peer support condition and breast cancer stage at Time 2. The full regression model consisted of 3 steps: The 1st step contained the baseline measure of the dependent variable. The 2nd step contained two dummy coded variables contrasting each condition with control. The 3rd step contained the interaction between the peer support condition and cancer stage. Patients in the education condition were excluded from this analysis.||||>0.05
72380070|NCT00245219|144268775|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|TWO_SIDED||||||Regression, Linear|||The comparison between the peer support condition and control condition at Time 3, among both late and early stage patients. The full regression model consisted of 3 steps: The 1st step contained the baseline measure of the dependent variable. The 2nd step contained two dummy coded variables contrasting each condition with control. The 3rd step contained the interaction between the peer support condition and cancer stage. Patients in the education condition were excluded from this analysis.||||>0.05
72380071|NCT00245219|144268775|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|TWO_SIDED||||||Regression, Linear|||The interaction between the peer support condition and breast cancer stage at Time 3. The full regression model consisted of 3 steps: The 1st step contained the baseline measure of the dependent variable. The 2nd step contained two dummy coded variables contrasting each condition with control. The 3rd step contained the interaction between the peer support condition and cancer stage. Patients in the education condition were excluded from this analysis.||||>0.05
72380072|NCT00245219|144268776|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|TWO_SIDED||||||Regression, Logistic|||The comparison between the peer support condition and the control condition at Time 2. The full regression model included 2 dummy coded variables, 1 contrasting the education and control condition, and 1 contrasting the peer support and control condition. The baseline measure of the outcome variable was included, in order to examine changes in the outcomes over time. This model tested the main effects of the conditions among patients with early stage cancer, late stage patients were excluded.||||>0.05
72380073|NCT00245219|144268776|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|TWO_SIDED||||||Regression, Logistic|||The comparison between the education condition and the control condition at Time 2. The full regression model included 2 dummy coded variables, 1 contrasting the education and control condition, and 1 contrasting the peer support and control condition. The baseline measure of the outcome variable was included, in order to examine changes in the outcomes over time. This model tested the main effects of the conditions among patients with early stage cancer, late stage patients were excluded.||||>0.05
72380074|NCT00245219|144268776|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|TWO_SIDED||||||Regression, Logistic|||The comparison between the peer support condition and the control condition at Time 3. The full regression model included 2 dummy coded variables, 1 contrasting the education and control condition, and 1 contrasting the peer support and control condition. The baseline measure of the outcome variable was included, in order to examine changes in the outcomes over time. This model tested the main effects of the conditions among patients with early stage cancer, late stage patients were excluded.||||>0.05
72380075|NCT00245219|144268776|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|TWO_SIDED||||||Regression, Logistic|||The comparison between the education condition and the control condition at Time 3. The full regression model included 2 dummy coded variables, 1 contrasting the education and control condition, and 1 contrasting the peer support and control condition. The baseline measure of the outcome variable was included, in order to examine changes in the outcomes over time. This model tested the main effects of the conditions among patients with early stage cancer, late stage patients were excluded.||||>0.05
72380076|NCT00245219|144268776|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|TWO_SIDED||||||Regression, Logistic|||The comparison between the peer support condition and control condition at Time 2, among both late and early stage patients. The full regression model consisted of 3 steps: The 1st step contained the baseline measure of the dependent variable. The 2nd step contained two dummy coded variables contrasting each condition with control. The 3rd step contained the interaction between the peer support condition and cancer stage. Patients in the education condition were excluded from this analysis.||||>0.05
72618558|NCT01026038|144768104|SUPERIORITY_OR_OTHER|||||||0.864||95.0|||||Fisher Exact|||Redness (Any): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.||||0.864
72618559|NCT01026038|144768104|SUPERIORITY_OR_OTHER|||||||0.859||95.0|||||Fisher Exact|||Redness (Mild): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/7vPnC/13vPnC.||||0.859
72380077|NCT00245219|144268776|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|TWO_SIDED||||||Regression, Logistic|||The interaction between the peer support condition and breast cancer stage at Time 2. The full regression model consisted of 3 steps: The 1st step contained the baseline measure of the dependent variable. The 2nd step contained two dummy coded variables contrasting each condition with control. The 3rd step contained the interaction between the peer support condition and cancer stage. Patients in the education condition were excluded from this analysis.||||>0.05
72380078|NCT00245219|144268776|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|TWO_SIDED||||||Regression, Logistic|||The comparison between the peer support condition and control condition at Time 3, among both late and early stage patients. The full regression model consisted of 3 steps: The 1st step contained the baseline measure of the dependent variable. The 2nd step contained two dummy coded variables contrasting each condition with control. The 3rd step contained the interaction between the peer support condition and cancer stage. Patients in the education condition were excluded from this analysis.||||>0.05
72380079|NCT00245219|144268776|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|TWO_SIDED||||||Regression, Logistic|||The interaction between the peer support condition and breast cancer stage at Time 3. The full regression model consisted of 3 steps: The 1st step contained the baseline measure of the dependent variable. The 2nd step contained two dummy coded variables contrasting each condition with control. The 3rd step contained the interaction between the peer support condition and cancer stage. Patients in the education condition were excluded from this analysis.||||>0.05
72380080|NCT01827358|144268780|OTHER|For strong control of the family-wise error rate at the 0.05 confidence level, the Holm procedure (Holm 1979) is used. Under this procedure, the p-values from the two tests are sorted as p\_((1)) (smaller p-value) and p\_((2)) (larger p-value). If p\_((1))=0.025 and p\_((2))=0.05, then the null hypotheses for both tests are rejected. If p\_((1))=0.025 and p\_((2))\>0.05, then only the null hypothesis associated with the smaller p-value is rejected. In any other case, neither null hypothesis is rejected|Odds Ratio (OR)|315.2|||<|0.001|TWO_SIDED|97.5|49.6|2698.8|||Fisher Exact|||||2698.8|49.6|<0.001
72380081|NCT01827358|144268781|OTHER|For strong control of the family-wise error rate at the 0.05 confidence level, the Holm procedure (Holm 1979) is used. Under this procedure, the p-values from the two tests are sorted as p\_((1)) (smaller p-value) and p\_((2)) (larger p-value). If p\_((1))=0.025 and p\_((2))=0.05, then the null hypotheses for both tests are rejected. If p\_((1))=0.025 and p\_((2))\>0.05, then only the null hypothesis associated with the smaller p-value is rejected. In any other case, neither null hypothesis is rejected|Odds Ratio (OR)|39.5|||<|0.001|TWO_SIDED|95.0|5.5|1666.3|||Fisher Exact|||||1666.3|5.5|<0.001
72380082|NCT01827358|144268782|OTHER||Hazard Ratio (HR)|1.0||||0.997|TWO_SIDED|95.0|0.3|3.28|||Cox proportional hazards model|||The association between mupirocin treatment and non-clinical SA Infection on or before Day 85 was assessed via a Cox Proportional Hazards Model. Onset time was defined as the first day of non-SA infection. Infants were right-censored at the time of discharge from the hospital or at Day 85, whichever came first.||3.28|0.30|0.997
72380083|NCT01827358|144268783|OTHER||Hazard Ratio (HR)|1.33||||0.656|TWO_SIDED|95.0|0.37|4.76|||Cox proportional hazards model|||The association between mupirocin treatment and non-clinical SA Infection on or before Day 85 was assessed via a Cox Proportional Hazards Model. Onset time was defined as the first day of non-SA infection. Infants were right-censored at the time of discharge from the hospital or at Day 85, whichever came first.||4.76|0.37|0.656
72380084|NCT01827358|144268785|OTHER||Hazard Ratio (HR)|0.23||||0.182|TWO_SIDED|95.0|0.03|2.01|||Cox proportional hazards models|||The time to clinical infection with SA on or prior to Day 22 was analyzed using Kaplan-Meier estimates of the survival curve and Cox proportional hazards models (with treatment as the only independent variable). Infants were censored at Day 22 or completion or early termination from the study. Estimates of the hazard ratio (values less than one indicating a treatment benefit) with Wald 95% confidence intervals and accompanying p-values were calculated.||2.01|0.03|0.182
72380085|NCT01827358|144268786|OTHER||Hazard Ratio (HR)|0.24||||0.198|TWO_SIDED|95.0|0.03|2.12|||Cox proportional hazards model|||The time to clinical infection with SA on or prior to Day 22 was analyzed using Kaplan-Meier estimates of the survival curve and Cox proportional hazards models (with treatment as the only independent variable). Infants were censored at Day 22 or completion or early termination from the study. Estimates of the hazard ratio (values less than one indicating a treatment benefit) with Wald 95% confidence intervals and accompanying p-values were calculated.||2.12|0.03|0.198
72380086|NCT00510952|144268791|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority margin was 0.4%.|Mean Difference (Net)|-0.05||||0.551||95.0|-0.21|0.11||P-value for Change from Baseline.|ANCOVA|ANCOVA Model: Variable = Treatment + Baseline + Country + Baseline Sulfonylurea Group.|The two-sided 95% confidence interval is for the Least Squares Mean difference between the two treatments (Insulin Lispro Protamine Suspension minus Glargine).|Hypothesis: Basal analog insulin lispro protamine suspension, injected once or twice daily is noninferior to basal analog insulin glargine, injected once a day, with regard to glycemic control as measured by change in HbA1c from baseline to 24 week endpoint (last observation carried forward).||0.11|-0.21|0.551
72380087|NCT00510952|144268792|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.06||||0.427||95.0|-0.21|0.09||P-value for Week 12 HbA1c.|ANCOVA|ANCOVA Model: Variable = Treatment + Baseline + Country + Baseline Sulfonylurea Group.|The two-sides 95% confidence interval is for the Least Squares Mean difference between the two treatments (Insulin Lispro Protamine Suspension minus Glargine).|||0.09|-0.21|0.427
72380088|NCT00510952|144268792|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.06||||0.427||95.0|-0.21|0.09||P-value for Week 12 Change from Baseline.|ANCOVA|ANCOVA Model: Variable = Treatment + Baseline + Country + Baseline Sulfonylurea Group.|The two-sides 95% confidence interval is for the Least Squares Mean difference between the two treatments (Insulin Lispro Protamine Suspension minus Glargine).|||0.09|-0.21|0.427
72380089|NCT00510952|144268792|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.09||||0.254||95.0|-0.25|0.07||P-value for Week 24 HbA1c.|ANCOVA|ANCOVA Model: Variable = Treatment + Baseline + Country + Baseline Sulfonylurea Group.|The two-sides 95% confidence interval is for the Least Squares Mean difference between the two treatments (Insulin Lispro Protamine Suspension minus Glargine).|||0.07|-0.25|0.254
72380090|NCT00510952|144268792|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.09||||0.254||95.0|-0.25|0.07||P-value for Week 24 Change from Baseline.|ANCOVA|ANCOVA Model: Variable = Treatment + Baseline + Country + Baseline Sulfonylurea Group.|The two-sides 95% confidence interval is for the Least Squares Mean difference between the two treatments (Insulin Lispro Protamine Suspension minus Glargine).|||0.07|-0.25|0.254
72380091|NCT00510952|144268793|SUPERIORITY_OR_OTHER|||||||0.634||95.0||||P-value for HbA1c \<7.0%.|Fisher Exact|||||||0.634
72556371|NCT01492439|144644029|SUPERIORITY_OR_OTHER|||||||0.171||||||This applies to the total score (forward + backwards) on the Digit Span Test.|ANCOVA|||||||0.171
72380092|NCT00510952|144268793|SUPERIORITY_OR_OTHER|||||||0.504||95.0||||P-value for HbA1c ≤6.5%.|Fisher Exact|||||||0.504
72380093|NCT00510952|144268794|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority margin of 0.8 millimoles per liter (mmol/L).|Mean Difference (Net)|0.06||||0.323||95.0|-0.06|0.19|||ANOVA|ANOVA Model: Variable = Treatment + Country + Baseline HbA1c + Baseline Sulfonylurea Group.|The two-sided 95% confidence interval is for the Least Squares Mean difference between the two treatment groups (Insulin Lispro Protamine Suspension minus Glargine).|Hypothesis: Insulin lispro protamine suspension is noninferior to glargine at actual morning pre-meal at endpoint.||0.19|-0.06|0.323
72380094|NCT00510952|144268795|SUPERIORITY_OR_OTHER|||||||0.302||95.0||||P-value for Actual Morning Pre-Meal.|ANOVA|ANOVA Model: Variable = Treatment + Country + Baseline HbA1c + Baseline Sulfonylurea Group.||||||0.302
72380095|NCT00510952|144268795|SUPERIORITY_OR_OTHER|||||||0.144||95.0||||P-value for Actual Morning Postprandial Meal.|ANOVA|ANOVA Model: Variable = Treatment + Country + Baseline HbA1c + Baseline Sulfonylurea Group.||||||0.144
72380096|NCT00510952|144268795|SUPERIORITY_OR_OTHER|||||||0.279||95.0||||P-value for Actual Midday Pre-Meal.|ANOVA|ANOVA Model: Variable = Treatment + Country + Baseline HbA1c + Baseline Sulfonylurea Group.||||||0.279
72380097|NCT00510952|144268795|SUPERIORITY_OR_OTHER|||||||0.928||95.0||||P-value for Actual Midday Postprandial Meal.|ANOVA|ANOVA Model: Variable = Treatment + Country + Baseline HbA1c + Baseline Sulfonylurea Group.||||||0.928
72380098|NCT00510952|144268795|SUPERIORITY_OR_OTHER|||||||0.918||95.0||||P-value for Actual Evening Pre-Meal.|ANOVA|ANOVA Model: Variable = Treatment + Country + Baseline HbA1c + Baseline Sulfonylurea Group.||||||0.918
72380099|NCT00510952|144268795|SUPERIORITY_OR_OTHER|||||||0.875||95.0||||P-value for Actual Evening Postprandial Meal.|ANOVA|ANOVA Model: Variable = Treatment + Country + Baseline HbA1c + Baseline Sulfonylurea Group.||||||0.875
72380100|NCT00510952|144268795|SUPERIORITY_OR_OTHER|||||||0.316||95.0||||P-value for Actual 0300 Hours.|ANOVA|ANOVA Model: Variable = Treatment + Country + Baseline HbA1c + Baseline Sulfonylurea Group.||||||0.316
72380101|NCT00510952|144268795|SUPERIORITY_OR_OTHER|||||||0.389||95.0||||P-value for Daily Mean 7-Point SMBG.|ANOVA|ANOVA Model: Variable = Treatment + Country + Baseline HbA1c + Baseline Sulfonylurea Group.||||||0.389
72380102|NCT00510952|144268795|SUPERIORITY_OR_OTHER|||||||0.836||95.0||||P-value for Daily Mean Pre-Meal.|ANOVA|ANOVA Model: Variable = Treatment + Country + Baseline HbA1c + Baseline Sulfonylurea Group.||||||0.836
72380103|NCT00510952|144268795|SUPERIORITY_OR_OTHER|||||||0.394||95.0||||P-value for Daily Mean Postprandial Meal.|ANOVA|ANOVA Model: Variable = Treatment + Country + Baseline HbA1c + Baseline Sulfonylurea Group.||||||0.394
72380104|NCT00510952|144268795|SUPERIORITY_OR_OTHER|||||||0.609||95.0||||P-value for Daily Mean Morning+Evening Pre-Meal.|ANOVA|ANOVA Model: Variable = Treatment + Country + Baseline HbA1c + Baseline Sulfonylurea Group.||||||0.609
72380105|NCT00510952|144268796|SUPERIORITY_OR_OTHER|||||||0.468||95.0||||P-value for All Hypoglycemic Episodes.|Fisher Exact|||||||0.468
72380106|NCT00510952|144268796|SUPERIORITY_OR_OTHER|||||||0.011||95.0||||P-value for Nocturnal Hypoglycemic Episodes.|Fisher Exact|||||||0.011
72380107|NCT00510952|144268796|SUPERIORITY_OR_OTHER|||||||0.036||95.0||||P-value for Severe Hypoglycemic Episodes.|Fisher Exact|||||||0.036
72380108|NCT00510952|144268797|SUPERIORITY_OR_OTHER|||||||0.316||95.0||||P-value for Hypoglycemic Rate.|ANOVA|Nonparametric ANOVA Model: Rank of Variable=Treatment + Country + Baseline HbA1c + Baseline Sulfonylurea Group. Hypoglycemic Rate (1 year) was used.||||||0.316
72380109|NCT00510952|144268797|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-Value for Nocturnal Hypoglycemic Rate.|ANOVA|Nonparametric ANOVA Model: Rank of Variable=Treatment + Country + Baseline HbA1c + Baseline Sulfonylurea Group. Hypoglycemic Rate (1 year) was used.||||||<0.001
72380110|NCT00510952|144268797|SUPERIORITY_OR_OTHER|||||||0.102||95.0||||P-value for Severe Hypoglycemic Rate.|ANOVA|Nonparametric ANOVA Model: Rank of Variable=Treatment + Country + Baseline HbA1c + Baseline Sulfonylurea Group. Hypoglycemic Rate (1 year) was used.||||||0.102
72380111|NCT00510952|144268799|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority margin of 1.5 kilograms (kg).|Mean Difference (Net)|-0.01||||0.975||95.0|-0.61|0.59||P-value for Change from Baseline.|ANCOVA|ANCOVA Model: Variable = Treatment + Baseline + Country + Baseline HbA1c + Baseline Sulfonylurea Group.|The two-sided 95% confidence interval is for the Least Squares Mean difference between the two treatments (Insulin Lispro Protamine Suspension minus Glargine).|Hypothesis: insulin lispro protamine suspension is noninferior to glargine with regard to change in absolute body weight from baseline to endpoint.||0.59|-0.61|0.975
72380112|NCT00510952|144268800|SUPERIORITY_OR_OTHER|||||||0.031||95.0|||||ANCOVA|ANCOVA Model: Variable = Treatment + Country + Baseline HbA1c + Baseline Sulfonylurea Group + Change in HbA1c from Baseline.||||||0.031
72380113|NCT00510952|144268801|SUPERIORITY_OR_OTHER|||||||0.015||95.0|||||ANCOVA|ANCOVA Model: Variable = Treatment + Country + Baseline HbA1c + Baseline Sulfonylurea Group + Change in HbA1c from Baseline.||||||0.015
72380114|NCT02101112|144268869|SUPERIORITY_OR_OTHER||Ratio of Adjusted Geometric Means|1.054|||||TWO_SIDED|90.0|0.994|1.118||||||Apixaban, 10 mg (crushed and suspended in water) vs. Apixaban, 10 mg (whole tablets)||1.118|0.994|
72380115|NCT02101112|144268869|SUPERIORITY_OR_OTHER||Ratio of Adjusted Geometric Means|0.788|||||TWO_SIDED|90.0|0.741|0.839||||||Apixaban, 10 mg (crushed and mixed with applesauce) vs. Apixaban, 10 mg (whole tablets)||0.839|0.741|
72380116|NCT02101112|144268870|SUPERIORITY_OR_OTHER||Ratio of Adjusted Geometric Means|1.027|||||TWO_SIDED|90.0|0.981|1.076||||||Apixaban, 10 mg (crushed and suspended in water) vs. Apixaban, 10 mg (whole tablets)||1.076|0.981|
72380117|NCT02101112|144268870|SUPERIORITY_OR_OTHER||Ratio of Adjusted Geometric Means|0.835|||||TWO_SIDED|90.0|0.797|0.875||||||Apixaban, 10 mg (crushed and mixed with applesauce) vs. Apixaban, 10 mg (whole tablets)||0.875|0.797|
72556372|NCT01492439|144644030|SUPERIORITY_OR_OTHER|||||||0.267|||||||ANCOVA|||||||0.267
72556373|NCT01492439|144644031|SUPERIORITY_OR_OTHER|||||||0.527|||||||ANCOVA|||||||0.527
72556374|NCT01492439|144644032|SUPERIORITY_OR_OTHER|||||||0.852||||||This applies to the percentage of perseverative errors on the WCST.|ANCOVA|||||||0.852
72556375|NCT01492439|144644032|SUPERIORITY_OR_OTHER|||||||0.637||||||This applies to the percentage of conceptual level responses on the WCST.|ANCOVA|||||||0.637
72556376|NCT01492439|144644033|SUPERIORITY_OR_OTHER|||||||0.612||||||This applies to the total number of correct categories on the WCST|ANCOVA|||||||0.612
72556377|NCT01492439|144644034|SUPERIORITY_OR_OTHER|||||||0.156||||||This applies to the percentage of perseverative errors on the WCST.|ANCOVA|||||||0.156
72380118|NCT02101112|144268871|SUPERIORITY_OR_OTHER||Ratio of Adjusted Geometric Means|1.027|||||TWO_SIDED|90.0|0.981|1.075||||||Apixaban, 10 mg (crushed and suspended in water) vs. Apixaban, 10 mg (whole tablets)||1.075|0.981|
72380119|NCT02101112|144268871|SUPERIORITY_OR_OTHER||Ratio of Adjusted Geometric Means|0.832|||||TWO_SIDED|90.0|0.794|0.871||||||Apixaban, 10 mg (crushed and mixed with applesauce) vs. Apixaban, 10 mg (whole tablets)||0.871|0.794|
72380120|NCT04340063|144268876|OTHER||Odds Ratio, log|0.4|||<|0.001|TWO_SIDED|95.0|0.25|0.55||Effect of time (pre-, mid-, and post- assessments)|Mixed Models Analysis|||A linear mixed-effects model (LMM) evaluated the effect of training (pre-, mid-, and post- assessments). Random effect of participant was used and fixed effects were time (assessment order) and a time by group interaction (Treadmill or Movement Amplification). A binomial distribution was used for this model.||0.55|0.25|<0.001
72380121|NCT04340063|144268876|OTHER||Odds Ratio, log|-0.03||||0.8|TWO_SIDED|95.0|-0.22|0.16||Interaction effect for time (pre-, mid-, and post- assessments) by group (Movement Amplification)|Mixed Models Analysis|||||0.16|-0.22|0.8
72380122|NCT04340063|144268876|OTHER||Odds Ratio, log|0.09||||0.5|TWO_SIDED|95.0|-0.18|0.36||Effect of time (post-training and follow-up assessments)|Mixed Models Analysis|||A linear mixed-effects model (LMM) evaluated the post-training and follow-up assessments if an effect was found during training. Random effect of participant and fixed effects of time (assessment order) and the time by group (Treadmill or Movement Amplification) interaction were used. A binomial distribution was used for this model.||0.36|-0.18|0.5
72380123|NCT04340063|144268876|OTHER||Odds Ratio, log|-0.07||||0.6|TWO_SIDED|95.0|-0.31|0.17||Interaction effect of time (post-training and follow-up assessments) by group (Movement Amplification)|Mixed Models Analysis|||A linear mixed-effects model (LMM) evaluated the post-training and follow-up assessments if an effect was found during training. Random effect of participant and fixed effects of time (assessment order) and the time by group (Treadmill or Movement Amplification) interaction were used. A binomial distribution was used for this model.||0.17|-0.31|0.6
72380124|NCT04340063|144268877|OTHER||Slope|0.06||||0.8|TWO_SIDED|95.0|-0.5|0.62||Effect of time (pre-, mid-, and post- assessments)|Mixed Models Analysis|||A linear mixed-effects model (LMM) evaluated the effect of training (pre-, mid-, and post- assessments). Random effect of participant and fixed effects of time (assessment order) and time by group (Treadmill or Movement Amplification) interaction were used||0.62|-0.50|0.8
72380125|NCT04340063|144268877|OTHER||Slope|-0.7||||0.012|TWO_SIDED|95.0|-1.2|-0.16||Interaction effect of time by group (Movement Amplification)|Mixed Models Analysis|||A linear mixed-effects model (LMM) evaluated the effect of training (pre-, mid-, and post- assessments). Random effect of participant and fixed effects of time (assessment order) and the time by group (Treadmill or Movement Amplification) interaction were used.||-0.16|-1.2|0.012
72380126|NCT04340063|144268877|OTHER||Slope|0.26||||0.3|TWO_SIDED|95.0|-0.22|0.75||Effect of time (post-training to follow-up)|Mixed Models Analysis|||A linear mixed-effects model (LMM) evaluated the post-training and follow-up assessments if an effect was found during training. Random effect of participant and fixed effects of time (assessment order) and the time by group (Treadmill or Movement Amplification) interaction were used.||0.75|-0.22|0.3
72380127|NCT04340063|144268877|OTHER||Slope|-0.2||||0.4|TWO_SIDED|95.0|-0.69|0.29||Interaction effect of time (post-training to follow-up) by group|Mixed Models Analysis|||A linear mixed-effects model (LMM) evaluated the post-training and follow-up assessments if an effect was found during training. Random effect of participant and fixed effects of time (assessment order) and the time by group (Treadmill or Movement Amplification) interaction were used.||0.29|-0.69|0.4
72380128|NCT04340063|144268878|OTHER||Slope|-52.0||||0.9|TWO_SIDED|95.0|-651.0|456.0||Effect of time (pre-, mid-, and post- assessments)|Mixed Models Analysis|||A linear mixed-effects model (LMM) evaluated the effect of training (pre-, mid-, and post- assessments). Random effect of participant and fixed effects of time (assessment order) and the time by group (Treadmill or Movement Amplification) interaction were used.||456|-651|0.9
72380129|NCT04340063|144268878|OTHER||Slope|79.0||||0.8|TWO_SIDED|95.0|-622.0|780.0||Interaction effect of time by group (Movement Amplification)|Mixed Models Analysis|||A linear mixed-effects model (LMM) evaluated the effect of training (pre-, mid-, and post- assessments). Random effect of participant and fixed effects of time (assessment order) and the time by group (Treadmill or Movement Amplification) interaction were used.||780|-622|0.8
72380130|NCT01857583|144268896|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|12.6|||||TWO_SIDED|95.0|-10.0|33.6|||ANCOVA|||||33.6|-10.0|
72380131|NCT01857583|144268896|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|17.3|||||TWO_SIDED|95.0|-10.2|42.1|||ANCOVA|||||42.1|-10.2|
72380132|NCT04894916|144268912|OTHER|single group|mean|81.9|||<|0.001|TWO_SIDED||||||t-test, 2 sided|||"One-sample t-test comparing the sample mean to the threshold value of 71 indicative of good usability. The null hypothesis: true mean is equal to 71."||||<0.001
72380133|NCT04894916|144268915|SUPERIORITY||Mean Difference (Net)|0.73|||<|0.01|TWO_SIDED||||||t-test, 2 sided|||||||<0.01
72380134|NCT04894916|144268916|OTHER||Mean Difference (Net)|1.17||||0.08|TWO_SIDED||||||t-test, 2 sided|||||||0.08
72380135|NCT04894916|144268917|OTHER|||||||0.68|||||||McNemar|||Analysis for pre-post change in knowledge of definition of A1C||||0.68
72380136|NCT04894916|144268917|OTHER|||||||0.18|||||||McNemar|||Analysis for pre-post change in knowledge of goal range for hemoglobin A1c.||||0.18
72380137|NCT04894916|144268917|OTHER|||||||0.18|||||||McNemar|||Analysis for pre-post change in knowledge of definition of systolic blood pressure||||0.18
72380138|NCT04894916|144268917|OTHER|||||||0.17|||||||McNemar|||Analysis of pre-post change in knowledge of goal range for systolic blood pressure||||0.17
72380139|NCT04894916|144268917|OTHER|||||||0.33|||||||McNemar|||Analysis of pre-post change in knowledge of definition of LDL cholesterol||||0.33
72380140|NCT04894916|144268917|OTHER|||||||0.4|||||||McNemar|||Analysis for pre-post change in knowledge of goal range for LDL cholesterol||||0.40
72380141|NCT04894916|144268917|OTHER|||||||1|||||||McNemar|||Analysis of pre-post change in knowledge of definition of flu vaccine||||1.00
72380142|NCT04894916|144268917|OTHER|||||||0.37|||||||McNemar|||Analysis of pre-post change in knowledge of recommended frequency of flu vaccination||||0.37
72380143|NCT04894916|144268918|OTHER||Mean Difference (Net)|-0.71||||0.16|TWO_SIDED||||||t-test, 2 sided|||||||0.16
72380144|NCT04894916|144268919|OTHER|||||||0.03|||||||McNemar|||Analysis of pre-post change in interest in information about how my diabetes health data compares to other patients like me (i.e., social comparison information)||||0.03
72556378|NCT01492439|144644034|SUPERIORITY_OR_OTHER|||||||0.926||||||This applies to the percentage of conceptual level responses on the WCST.|ANCOVA|||||||0.926
72380145|NCT04894916|144268919|OTHER|||||||0.45|||||||McNemar|||Analysis of pre-post change in interest in information about how their diabetes health data compares to the goal range (i.e., goal-based comparison information)||||0.45
72380146|NCT04894916|144268919|OTHER|||||||0.17|||||||McNemar|||Analysis of pre-post change in agreement with statement: 'Information about how my diabetes health data compares to other patients like me \[social comparison information\] is useful.||||0.17
72380147|NCT04894916|144268919|OTHER|||||||0.62|||||||McNemar|||Analysis of pre-post change in agreement with statement: 'Information about how my diabetes health data compares to the goals range \[goal-based comparison information\] is useful.||||0.62
72380148|NCT04894916|144268921|OTHER||Mean Difference (Net)|0.09||||0.53|TWO_SIDED||||||t-test, 2 sided|||||||0.53
72380149|NCT04894916|144268922|OTHER||Mean Difference (Net)|0.03||||0.86|TWO_SIDED||||||t-test, 2 sided|||||||0.86
72380150|NCT04894916|144268923|OTHER||Mean Difference (Net)|0.28||||0.22|TWO_SIDED||||||t-test, 2 sided|||||||0.22
72380151|NCT04894916|144268924|OTHER||Mean Difference (Net)|0.25||||0.21|TWO_SIDED||||||t-test, 2 sided|||||||0.21
72380152|NCT04894916|144268925|OTHER||Mean Difference (Net)|-0.39||||0.18|TWO_SIDED||||||t-test, 2 sided|||||||0.18
72556379|NCT01492439|144644035|SUPERIORITY_OR_OTHER|||||||0.843|||||||ANCOVA|||This applies to the total number of categories on the WCST.||||0.843
72556380|NCT01492439|144644036|SUPERIORITY_OR_OTHER|||||||0.129||||||This applies to the total number of errors made on the DVT.|ANCOVA|||||||0.129
72556381|NCT01492439|144644037|SUPERIORITY_OR_OTHER|||||||0.004|||||||ANCOVA|||This applies to the total time taken to complete the DVT.||||0.004
72380153|NCT00396032|144268942|SUPERIORITY_OR_OTHER|||||||0.0044||95.0||||Stratified by baseline BFR: 0-199 mL/min, 200-274 mL/min, and 275-299 mL/min.|Cochran-Mantel-Haenszel|||||||0.0044
72556382|NCT01492439|144644038|SUPERIORITY_OR_OTHER|||||||0.853|||||||ANCOVA|This applies to the total number of errors on the DVT.||||||0.853
72556383|NCT01492439|144644039|SUPERIORITY_OR_OTHER|||||||0.468|||||||ANCOVA|||This applies to the total time taken to complete the DVT.||||0.468
72556384|NCT00824291|144644056|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.12||||0.002|TWO_SIDED|95.0|0.78|3.46|||ANCOVA|||||3.46|0.78|0.002
72380154|NCT00396032|144268942|SUPERIORITY_OR_OTHER|||||||0.0035||95.0|||||Chi-squared|||||||0.0035
72380155|NCT00396032|144268944|SUPERIORITY_OR_OTHER|||||||0.0396||95.0||||Stratified by baseline BFR: 0-199 mL/min, 200-274 mL/min, and 275-299 mL/min.|Cochran-Mantel-Haenszel|||||||0.0396
72380156|NCT05523323|144268947|OTHER||Estimate difference|29.5||||0.0002014|TWO_SIDED|95.0|14.0|43.9|||Unstratified Miettinen & Nurminen method|One-sided p-value was calculated using the unstratified Miettinen \& Nurminen method.|The exact binomial method by Clopper and Pearson was used to generate the estimate difference and the associated 95% confidence intervals (CIs).|||43.9|14.0|0.0002014
72380157|NCT05523323|144268948|OTHER||Hazard Ratio (HR)|0.34||||3.7e-06|TWO_SIDED|95.0|0.21|0.55|||unstratified Log-rank test.|One-sided p-value was calculated using unstratified Log-rank test.|The unstratified Cox-Regression model with Efron's method of tie handling with treatment as covariate was used to generate Hazard Ratio (HR) and the associated 95%CI.|||0.55|0.21|0.0000037
72380158|NCT05523323|144268949|OTHER||Hazard Ratio (HR)|0.86||||0.30933|TWO_SIDED|95.0|0.49|1.54|||Unstratified Log-rank test|One-sided p-value was calculated using unstratified Log-rank test.|The unstratified Cox-Regression model with Efron's method of tie handling with treatment as covariate was used to generate Hazard Ratio (HR) and the associated 95%CI.|||1.54|0.49|0.30933
72380159|NCT01948310|144268959|SUPERIORITY||||||>|0.05|||||||t-test, 2 sided|||2-0 weeks||||>0.05
72380160|NCT01948310|144268959|SUPERIORITY|||||||0.03|||||||t-test, 2 sided|||0-14 weeks||||0.03
72380161|NCT01948310|144268959|SUPERIORITY||||||>|0.05|||||||t-test, 2 sided|||2-0 weeks||||>0.05
72380162|NCT01948310|144268959|SUPERIORITY|||||||0.005|||||||t-test, 2 sided|||14-0 weeks||||0.005
72380163|NCT01948310|144268960|SUPERIORITY||||||>|0.05|||||||t-test, 2 sided|||2-0 weeks||||>0.05
72380164|NCT01948310|144268960|SUPERIORITY||||||>|0.05|||||||t-test, 2 sided|||14-0 weeks||||>0.05
72380165|NCT01948310|144268960|SUPERIORITY|||||||0.03|||||||t-test, 2 sided|||2-0 weeks||||0.03
72380166|NCT01948310|144268960|SUPERIORITY||||||>|0.05|||||||t-test, 2 sided|||14-0 weeks||||>0.05
72380167|NCT01948310|144268961|SUPERIORITY||||||>|0.05|||||||t-test, 2 sided|||2-0 weeks||||>0.05
72380168|NCT01948310|144268961|SUPERIORITY|||||||0.13|||||||t-test, 2 sided|||0-14 weeks||||0.13
72380169|NCT01948310|144268961|SUPERIORITY||||||>|0.05|||||||t-test, 2 sided|||2-0 weeks||||>0.05
72380170|NCT01948310|144268961|SUPERIORITY|||||||0.013|||||||t-test, 2 sided|||14-0 weeks||||0.013
72380171|NCT00920829|144268970|SUPERIORITY|||||||0.724|||||||Mixed Models Analysis|||A linear mixed model with unstructured variance/covariance matrices was used to evaluate the primary outcome measure.||||0.724
72380172|NCT00920829|144268970|SUPERIORITY|||||||0.023|||||||Mixed Models Analysis|||This is a test of the main effect of medication, with a null hypothesis of no difference between Naltrexone and Placebo groups.||||0.023
72380173|NCT05654441|144268974|OTHER||||||<|0.001|||||||ANOVA|||||||<0.001
72380174|NCT05654441|144268975|OTHER||||||<|0.001|||||||ANOVA|||||||<0.001
72380175|NCT05654441|144268976|OTHER|||||||0.007|||||||ANOVA|||||||0.007
72380176|NCT05654441|144268977|OTHER||||||<|0.001|||||||ANOVA|||||||<0.001
72380177|NCT05654441|144268978|OTHER|||||||0.886|||||||t-test, 2 sided|||||||0.886
72380178|NCT05654441|144268979|OTHER|||||||0.666|||||||t-test, 2 sided|||||||.666
72380179|NCT05654441|144268980|OTHER|||||||0.522|||||||t-test, 2 sided|||||||.522
72380180|NCT05654441|144268981|OTHER|||||||0.438|||||||t-test, 2 sided|||||||.438
72380181|NCT05654441|144268982|OTHER|||||||0.181|||||||t-test, 2 sided|||||||.181
72556385|NCT00824291|144644057|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.33||||0.067|TWO_SIDED|95.0|-0.09|2.76|||ANCOVA|||||2.76|-0.09|0.067
72556386|NCT00824291|144644058|SUPERIORITY_OR_OTHER|||||||0.001|||||||Cochran-Mantel-Haenszel|||||||0.001
72556387|NCT00824291|144644059|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||Cochran-Mantel-Haenszel|||||||0.002
72556388|NCT00824291|144644060|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.23||||0.04|TWO_SIDED|95.0|0.01|0.44|||ANCOVA|||||0.44|0.01|0.040
72556389|NCT00824291|144644061|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.26||||0.035|TWO_SIDED|95.0|0.16|4.37|||ANCOVA|||||4.37|0.16|0.035
72556390|NCT00824291|144644062|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.44||||0.041|TWO_SIDED|95.0|0.1|4.78|||ANCOVA|||||4.78|0.10|0.041
72556391|NCT00824291|144644063|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.39||||0.145|TWO_SIDED|95.0|-0.13|0.91|||ANCOVA|||||0.91|-0.13|0.145
72380182|NCT05654441|144268983|OTHER|||||||0.833|||||||t-test, 2 sided|||||||.833
72380183|NCT05654441|144268984|OTHER|||||||0.455|||||||t-test, 2 sided|||||||.455
72380184|NCT03718871|144269016|SUPERIORITY||intracluster correlation coefficient|0.086|||<|0.001|TWO_SIDED|95.0|0.015|0.363||The threshold for significance was set at p \< 0.05.|Fisher Exact|||Given that the intervention arm showed 100% uptake, a multi-level regression model could not be created with a zero in the denominator in the intervention group. We therefore used Fisher's exact test to assess for significant differences in proportion of HIV testing between study arms.||0.363|0.015|<0.001
72380185|NCT03718871|144269017|SUPERIORITY|||||||0.002|||||||Fisher Exact|||||||0.002
72380186|NCT03718871|144269018|SUPERIORITY|||||||0.015|||||||Fisher Exact|||||||0.015
72380187|NCT03718871|144269019|OTHER|No comparison between study arm groups was made in this analysis, as it was limited to control arm only.|Odds Ratio (OR)|1.04|STANDARD_DEVIATION|0.039|<|0.01|TWO_SIDED|95.0|1.02|1.06||Significance threshold two-sided alpha = 0.05|Regression, Linear|||We considered variables that predicted the primary outcome of receiving an HIV test among control arm only, as uptake was 100% in the intervention. First we identified variables that were significant (two-sided p-value\<0.05) in univariate analysis and creating multivariate mixed-effects logistic regression model accounting for covariates and intercorrelation between participants from the same healer by including healers as random effects.||1.06|1.02|<0.01
72380188|NCT03718871|144269020|OTHER|No comparison was made with the intervention arm|Odds Ratio (OR)|0.56||||0.07|TWO_SIDED|95.0|0.3|1.04||Univariate analysis|Fisher Exact|||We considered variables that predicted the primary outcome of receiving an HIV test among control arm only, as uptake was 100% in the intervention. First we identified variables that were significant (two-sided p-value\<0.05) in univariate analysis and creating multivariate mixed-effects logistic regression model accounting for covariates and intercorrelation between participants from the same healer by including healers as random effects.||1.04|0.30|0.07
72380189|NCT03718871|144269021|OTHER|Comparison between study arms was not performed|Odds Ratio (OR)|0.43||||0.09|TWO_SIDED|95.0|0.16|1.18|||Fisher Exact|||We considered variables that predicted the primary outcome of receiving an HIV test among control arm only, as uptake was 100% in the intervention. First we identified variables that were significant (two-sided p-value\<0.05) in univariate analysis and creating multivariate mixed-effects logistic regression model accounting for covariates and intercorrelation between participants from the same healer by including healers as random effects.||1.18|0.16|0.09
72380190|NCT00054717|144269065|SUPERIORITY_OR_OTHER|||||||0.0001||95.0|||||Cochran-Mantel-Haenszel|Weighted by the size of enfuvirtide and protease inhibitor strata||||||0.0001
72380191|NCT00054717|144269066|SUPERIORITY_OR_OTHER|||||||0.0001||95.0|||||Log Rank|||||||0.0001
72618560|NCT01026038|144768104|SUPERIORITY_OR_OTHER|||||||0.836||95.0|||||Fisher Exact|||Redness (Mild): Fisher exact test, 2-sided was used. Pairwise comparison was made between 7vPnC/7vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.||||0.836
72380192|NCT00054717|144269067|SUPERIORITY_OR_OTHER|||||||0.0001||95.0|||||Cochran-Mantel-Haenszel|Weighted by the size of enfuvirtide and protease inhibitor strata||||||0.0001
72380193|NCT00054717|144269068|SUPERIORITY_OR_OTHER|||||||0.0001||95.0|||||Cochran-Mantel-Haenszel|Weighted by the size of enfuvirtide and protease inhibitor strata||||||0.0001
72380194|NCT00054717|144269069|SUPERIORITY_OR_OTHER|||||||0.0001||95.0|||||Cochran-Mantel-Haenszel|Weighted by the size of enfuvirtide and protease inhibitor strata||||||0.0001
72380195|NCT00054717|144269070|SUPERIORITY_OR_OTHER|||||||0.0001||95.0|||||Cochran-Mantel-Haenszel|Weighted by the size of enfuvirtide and protease inhibitor strata||||||0.0001
72380196|NCT00054717|144269071|SUPERIORITY_OR_OTHER|||||||0.0001||95.0|||||Cochran-Mantel-Haenszel|Weighted by the size of enfuvirtide and protease inhibitor strata||||||0.0001
72380197|NCT00054717|144269072|SUPERIORITY_OR_OTHER|||||||0.0001||95.0|||||Cochran-Mantel-Haenszel|Weighted by the size of enfuvirtide and protease inhibitor strata||||||0.0001
72380198|NCT00054717|144269073|SUPERIORITY_OR_OTHER|||||||0.0001||95.0|||||Cochran-Mantel-Haenszel|Weighted by the size of enfuvirtide and protease inhibitor strata||||||0.0001
72380199|NCT00054717|144269074|SUPERIORITY_OR_OTHER|||||||0.0001||95.0|||||Cochran-Mantel-Haenszel|Weighted by the size of enfuvirtide and protease inhibitor strata||||||0.0001
72380200|NCT00054717|144269075|SUPERIORITY_OR_OTHER|||||||0.0001||95.0|||||Cochran-Mantel-Haenszel|Weighted by the size of enfuvirtide and protease inhibitor strata||||||0.0001
72380201|NCT00054717|144269076|SUPERIORITY_OR_OTHER|||||||0.0001||95.0|||||Cochran-Mantel-Haenszel|Weighted by the size of enfuvirtide and protease inhibitor strata||||||0.0001
72380202|NCT00054717|144269077|SUPERIORITY_OR_OTHER|||||||0.0001||95.0|||||Cochran-Mantel-Haenszel|Weighted by the size of enfuvirtide and protease inhibitor strata||||||0.0001
72380203|NCT00054717|144269078|SUPERIORITY_OR_OTHER|||||||0.0001||95.0|||||Cochran-Mantel-Haenszel|Weighted by the size of enfuvirtide and protease inhibitor strata||||||0.0001
72380204|NCT00054717|144269079|SUPERIORITY_OR_OTHER|||||||0.0001||95.0|||||Cochran-Mantel-Haenszel|Weighted by the size of enfuvirtide and protease inhibitor strata||||||0.0001
72380205|NCT00054717|144269080|SUPERIORITY_OR_OTHER|||||||0.0001||95.0|||||Cochran-Mantel-Haenszel|Weighted by the size of enfuvirtide and protease inhibitor strata||||||0.0001
72380206|NCT00054717|144269081|SUPERIORITY_OR_OTHER|||||||0.0001||95.0|||||Cochran-Mantel-Haenszel|Weighted by the size of enfuvirtide and protease inhibitor strata||||||0.0001
72380207|NCT00054717|144269082|SUPERIORITY_OR_OTHER|||||||0.0001||95.0|||||Log Rank|||||||0.0001
72380208|NCT00054717|144269083|SUPERIORITY_OR_OTHER|||||||0.0001||95.0|||||Log Rank|||||||0.0001
72380209|NCT00054717|144269084|SUPERIORITY_OR_OTHER|||||||0.0001||95.0|||||Log Rank|||||||0.0001
72380210|NCT00054717|144269124|SUPERIORITY_OR_OTHER|||||||0.9894||95.0|||||Log Rank|||||||0.9894
72380211|NCT04626310|144269211|SUPERIORITY||Linear slope difference DBT-ER-IP|0.096|STANDARD_ERROR_OF_MEAN|0.08||0.8|TWO_SIDED||||||Mixed Models Analysis|||Comparisons of Linear Slopes (DBT-ER vs. IP) in latent growth curve models (in multilevel/mixed effects framework, Mplus v8.1) with quadratic effects.||||.8
72380212|NCT04626310|144269211|SUPERIORITY||Linear Slope difference DBT-IE-IP|-0.234|STANDARD_ERROR_OF_MEAN|0.385||0.544|TWO_SIDED||||||Mixed Models Analysis|||Comparisons of Linear Slopes (DBT-IE vs. IP) in latent growth curve models (in multilevel/mixed effects framework, Mplus v8.1) with quadratic effects.||||.544
72556392|NCT00395694|144644074|SUPERIORITY_OR_OTHER||Percentage of participants|4.9|||||TWO_SIDED|95.0|1.6|11.1|||||The estimated value represents the percentage of participants with rash events.|||11.1|1.6|
72380213|NCT04626310|144269211|SUPERIORITY||Linear Slope difference DBT-ER-DBT-IE|0.329|STANDARD_ERROR_OF_MEAN|0.429||0.442|TWO_SIDED||||||Mixed Models Analysis|||Comparisons of Linear Slopes (DBT-ER vs. DBT-IE) in latent growth curve models (in multilevel/mixed effects framework, Mplus v8.1) with quadratic effects.||||.442
72380214|NCT04626310|144269212|SUPERIORITY||Linear slope difference DBT-ER-IP|1.951|STANDARD_ERROR_OF_MEAN|1.15||0.09|TWO_SIDED||||||Mixed Models Analysis|||Comparisons of Linear Slopes (DBT-ER vs. IP) in latent growth curve models (in multilevel/mixed effects framework, Mplus v8.1) with quadratic effects.||||.09
72380215|NCT04626310|144269212|SUPERIORITY||Linear slope difference DBT-IE-IP|0.1|STANDARD_ERROR_OF_MEAN|1.228||0.93|TWO_SIDED||||||Mixed Models Analysis|||Comparisons of Linear Slopes (DBT-ER vs. DBT-IE) in latent growth curve models (in multilevel/mixed effects framework, Mplus v8.1) with quadratic effects.||||.93
72380216|NCT04626310|144269212|SUPERIORITY||Linear slope difference DBT-ER-DBT-IE|1.851|STANDARD_ERROR_OF_MEAN|1.103||0.93|TWO_SIDED||||||Mixed Models Analysis|||Comparisons of Linear Slopes (DBT-ER vs. DBT-IE) in latent growth curve models (in multilevel/mixed effects framework, Mplus v8.1) with quadratic effects.||||.93
72380217|NCT04626310|144269212|SUPERIORITY||Quad slope difference DBT-ER-IP|-0.028|STANDARD_ERROR_OF_MEAN|0.15||0.93|TWO_SIDED||||||Mixed Models Analysis|||Comparisons of Quadratic Slopes (DBT-ER vs. IP) in latent growth curve models (in multilevel/mixed effects framework, Mplus v8.1) with quadratic effects.||||.93
72380218|NCT04626310|144269212|SUPERIORITY||Quad slope difference DBT-IE-IP|-0.029|STANDARD_ERROR_OF_MEAN|0.145||0.836|TWO_SIDED||||||Mixed Models Analysis|||Comparisons of Quadratic Slopes (DBT-IE vs. IP) in latent growth curve models (in multilevel/mixed effects framework, Mplus v8.1) with quadratic effects.||||.836
72380219|NCT04626310|144269212|SUPERIORITY||Quad slope difference DBT-ER-DBT-IE|0.001|STANDARD_ERROR_OF_MEAN|0.145||0.994|TWO_SIDED||||||Mixed Models Analysis|||Comparisons of Quadratic Slopes (DBT-IE vs. IP) in latent growth curve models (in multilevel/mixed effects framework, Mplus v8.1) with quadratic effects.||||.994
72380220|NCT04626310|144269213|SUPERIORITY||Linear slope difference DBT-ER-IP|0.059|STANDARD_ERROR_OF_MEAN|0.083||0.475|TWO_SIDED||||||Mixed Models Analysis|||Latent growth curve models (in multilevel/mixed effects framework, Mplus v8.1) were estimated with maximum likelihood. The slopes of the difference between neutral and negative-maintain were regressed on time (weeks, centered around the start of treatment) and calculated per condition. Models tested whether these slopes differed by condition. This test compared DBT-ER to IP.||||.475
72380221|NCT04626310|144269213|SUPERIORITY||Linear slope difference DBT-IE-IP|0.037|STANDARD_ERROR_OF_MEAN|0.082||0.654|TWO_SIDED||||||Mixed Models Analysis|||Latent growth curve models (in multilevel/mixed effects framework, Mplus v8.1) were estimated with maximum likelihood. The slopes of the difference between neutral and negative-maintain were regressed on time (weeks, centered around the start of treatment) and calculated per condition. Models tested whether these slopes differed by condition. This test compared DBT-IE to IP.||||.654
72556393|NCT01648582|144644086|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analyses were based on a pre-defined non-inferiority margin of 0.4%.|Mean Difference (Net)|-0.57|||||TWO_SIDED|95.0|-0.74|-0.4||||||||-0.40|-0.74|
72556394|NCT01648582|144644086|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analyses were based on a pre-defined non-inferiority margin of 0.4%.|Mean Difference (Net)|-0.18|||||TWO_SIDED|95.0|-0.35|-0.01||||||||-0.01|-0.35|
72380222|NCT04626310|144269213|SUPERIORITY||Linear slope difference DBT-ER-DBT-IE|0.022|STANDARD_ERROR_OF_MEAN|0.085||0.791|TWO_SIDED||||||Mixed Models Analysis|||Latent growth curve models (in multilevel/mixed effects framework, Mplus v8.1) were estimated with maximum likelihood. The slopes of the difference between neutral and negative-maintain were regressed on time (weeks, centered around the start of treatment) and calculated per condition. Models tested whether these slopes differed by condition. This test compared DBT-ER to DBT-IE.||||.791
72380223|NCT04626310|144269214|SUPERIORITY||Linear slope difference DBT-ER-IP|-0.332|STANDARD_ERROR_OF_MEAN|0.095||0.001|TWO_SIDED||||||Mixed Models Analysis|||Latent growth curve models (in multilevel/mixed effects framework, Mplus v8.1) were estimated with maximum likelihood. We examined the effect of Negative Decrease vs. Negative Maintain over time per condition. Models tested whether these slopes differed by condition. This test compared DBT-ER to IP.||||.001
72380224|NCT04626310|144269214|SUPERIORITY||Linear slope difference DBT-IE-IP|-0.165|STANDARD_ERROR_OF_MEAN|0.094||0.078|TWO_SIDED||||||Mixed Models Analysis|||Latent growth curve models (in multilevel/mixed effects framework, Mplus v8.1) were estimated with maximum likelihood. We examined the effect of Negative Decrease vs. Negative Maintain over time per condition. Models tested whether these slopes differed by condition. This test compared DBT-IE to IP.||||.078
72380225|NCT04626310|144269214|SUPERIORITY||Linear slope difference DBT-ER-DBT-IE|-0.167|STANDARD_ERROR_OF_MEAN|0.095||0.08|TWO_SIDED||||||Mixed Models Analysis|||Latent growth curve models (in multilevel/mixed effects framework, Mplus v8.1) were estimated with maximum likelihood. We examined the effect of Negative Decrease vs. Negative Maintain over time per condition. Models tested whether these slopes differed by condition. This test compared DBT-ER to DBT-IE.||||.080
72380226|NCT04626310|144269215|SUPERIORITY||Linear Slope Diff DBT-ER-IP|0.091|STANDARD_ERROR_OF_MEAN|0.06||0.13|TWO_SIDED||||||Mixed Models Analysis|||Latent growth curve models (in multilevel/mixed effects framework, Mplus v8.1) were estimated with maximum likelihood. The Negative x Novel x time (weeks, centered around the start of treatment) slopes were calculated per condition. Models tested whether these slopes differed by condition. This test compared DBT-ER to IP.||||.13
72380227|NCT04626310|144269215|SUPERIORITY||Linear slope difference DBT-IE-IP|0.12|STANDARD_ERROR_OF_MEAN|0.06||0.046|TWO_SIDED||||||Mixed Models Analysis|||Latent growth curve models (in multilevel/mixed effects framework, Mplus v8.1) were estimated with maximum likelihood. The Negative x Novel x time (weeks, centered around the start of treatment) slopes were calculated per condition. Models tested whether these slopes differed by condition. This test compared DBT-IE to IP.||||.046
72556395|NCT01648582|144644087|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analyses were based on a pre-defined non-inferiority margin of 0.4%.|Mean Difference (Net)|-0.57|||||TWO_SIDED|95.0|-0.77|-0.38||||||||-0.38|-0.77|
72556396|NCT01648582|144644087|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analyses were based on a pre-defined non-inferiority margin of 0.4%.|Mean Difference (Net)|-0.13|||||TWO_SIDED|95.0|-0.33|-0.06||||||||-0.06|-0.33|
72556397|NCT01648582|144644088|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Fisher Exact|||\<7.0% Week 26||||<0.001
72556398|NCT01648582|144644088|SUPERIORITY_OR_OTHER_LEGACY|||||||0.004|||||||Fisher Exact|||\<7.0 Week 26||||0.004
72618561|NCT01026038|144768104|SUPERIORITY_OR_OTHER||||||>|0.99||95.0|||||Fisher Exact|||Redness (Mild): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.||||>0.990
72556399|NCT01648582|144644088|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Fisher Exact|||\<=6.5% Week 26||||<0.001
72380228|NCT04626310|144269215|SUPERIORITY||Linear slope difference DBT-ER-DBT-IE|-0.028|STANDARD_ERROR_OF_MEAN|0.057||0.617|TWO_SIDED||||||Mixed Models Analysis|||Latent growth curve models (in multilevel/mixed effects framework, Mplus v8.1) were estimated with maximum likelihood. The Negative x Novel x time (weeks, centered around the start of treatment) slopes were calculated per condition. Models tested whether these slopes differed by condition. This test compared DBT-ER to DBT-IE.||||.617
72380229|NCT04626310|144269216|SUPERIORITY||Linear slope difference DBT-ER-IP|-0.29|STANDARD_ERROR_OF_MEAN|0.103||0.005|TWO_SIDED||||||Mixed Models Analysis|||Latent growth curve models (in multilevel/mixed effects framework, Mplus v8.1) were estimated with maximum likelihood. Simple slopes of change in this interaction effect were calculated for each condition. Models tested whether these slopes differed by condition. This test compared DBT-ER to IP.||||.005
72380230|NCT04626310|144269216|SUPERIORITY||Linear slope difference DBT-IE-IP|-0.111|STANDARD_ERROR_OF_MEAN|0.103||0.281|TWO_SIDED||||||Mixed Models Analysis|||Latent growth curve models (in multilevel/mixed effects framework, Mplus v8.1) were estimated with maximum likelihood. Simple slopes of change in this interaction effect were calculated for each condition. Models tested whether these slopes differed by condition. This test compared DBT-IE to IP.||||.281
72380231|NCT04626310|144269216|SUPERIORITY||Linear slope difference DBT-ER-DBT-IE|-0.18|STANDARD_ERROR_OF_MEAN|0.098||0.066|TWO_SIDED||||||Mixed Models Analysis|||Latent growth curve models (in multilevel/mixed effects framework, Mplus v8.1) were estimated with maximum likelihood. Simple slopes of change in this interaction effect were calculated for each condition. Models tested whether these slopes differed by condition. This test compared DBT-ER to DBT-IE.||||.066
72380232|NCT04626310|144269217|SUPERIORITY||Linear slope difference DBT-ER-IP|1.049|STANDARD_ERROR_OF_MEAN|0.653||0.108|TWO_SIDED||||||Mixed Models Analysis|||Latent growth curve models (in multilevel/mixed effects framework, Mplus v8.1) were estimated with maximum likelihood. Simple slopes of the effect of negative maintain vs. neutral images on weeks were calculated for each condition. Models tested whether these slopes differed by condition. This test compared DBT-ER to IP.||||.108
72380233|NCT04626310|144269217|SUPERIORITY||Linear slope difference DBT-IE-IP|-1.21|STANDARD_ERROR_OF_MEAN|0.454||0.014|TWO_SIDED||||||Mixed Models Analysis|||Latent growth curve models (in multilevel/mixed effects framework, Mplus v8.1) were estimated with maximum likelihood. Simple slopes of the effect of negative maintain vs. neutral images on weeks were calculated for each condition. Models tested whether these slopes differed by condition. This test compared DBT-IE to IP.||||.014
72380234|NCT04626310|144269217|SUPERIORITY||Linear slope difference DBT-ER-DBT-IE|2.17|STANDARD_ERROR_OF_MEAN|0.631||0.001|TWO_SIDED||||||Mixed Models Analysis|||Latent growth curve models (in multilevel/mixed effects framework, Mplus v8.1) were estimated with maximum likelihood. Simple slopes of the effect of negative maintain vs. neutral images on weeks were calculated for each condition. Models tested whether these slopes differed by condition. This test compared DBT-ER to DBT-IE.||||.001
72380235|NCT04626310|144269218|OTHER||Linear Slope difference DBT-ER-IP|0.17|STANDARD_ERROR_OF_MEAN|0.136||0.211|TWO_SIDED||||||Mixed Models Analysis|||Latent growth curve models (in multilevel/mixed effects framework, Mplus v8.1) were estimated with maximum likelihood. Simple slopes of the effect of negative maintain vs. negative decrease on weeks were calculated for each condition. Models tested whether these slopes differed by condition. This test compared DBT-ER to IP.||||.211
72380236|NCT04626310|144269218|SUPERIORITY||Linear Slope difference DBT-IE-IP|-0.195|STANDARD_ERROR_OF_MEAN|0.135||0.148|TWO_SIDED||||||Mixed Models Analysis|||Latent growth curve models (in multilevel/mixed effects framework, Mplus v8.1) were estimated with maximum likelihood. Simple slopes of the effect of negative maintain vs. negative decrease on weeks were calculated for each condition. Models tested whether these slopes differed by condition. This test compared DBT-IE to IP.||||.148
72380237|NCT04626310|144269218|SUPERIORITY||Linear Slope difference DBT-ER-DBT-IE|-0.025|STANDARD_ERROR_OF_MEAN|0.137||0.857|TWO_SIDED||||||Mixed Models Analysis|||Latent growth curve models (in multilevel/mixed effects framework, Mplus v8.1) were estimated with maximum likelihood. Simple slopes of the effect of negative maintain vs. negative decrease on weeks were calculated for each condition. Models tested whether these slopes differed by condition. This test compared DBT-ER to DBT-IE.||||.857
72380238|NCT04626310|144269219|SUPERIORITY||Linear Slope Difference in DSS DBT-ER-IP|-0.313|STANDARD_ERROR_OF_MEAN|0.794||0.693|TWO_SIDED||||||Mixed Models Analysis|||Latent growth curve models (in multilevel/mixed effects framework, Mplus v8.1) were estimated with maximum likelihood. Simple slopes of DSS over weeks were calculated for each condition. Models tested whether these slopes differed by condition. This test compared DBT-ER to IP.||||.693
72380239|NCT04626310|144269219|SUPERIORITY||Linear Slope Difference in DSS DBT-IE-IP|0.002|STANDARD_ERROR_OF_MEAN|0.767||0.998|TWO_SIDED||||||Mixed Models Analysis|||Latent growth curve models (in multilevel/mixed effects framework, Mplus v8.1) were estimated with maximum likelihood. Simple slopes of DSS over weeks were calculated for each condition. Models tested whether these slopes differed by condition. This test compared DBT-IE to IP.||||.998
72380240|NCT04626310|144269219|SUPERIORITY||Linear Slope Diff in DSS DBT-ER-DBT-IE|-0.315|STANDARD_ERROR_OF_MEAN|0.765||0.68|TWO_SIDED||||||Mixed Models Analysis|||Latent growth curve models (in multilevel/mixed effects framework, Mplus v8.1) were estimated with maximum likelihood. Simple slopes of DSS over weeks were calculated for each condition. Models tested whether these slopes differed by condition. This test compared DBT-ER to DBT-IE.||||.680
72380241|NCT04626310|144269219|SUPERIORITY||Linear Slope Difference in DC1 DBT-ER-IP|0.098|STANDARD_ERROR_OF_MEAN|0.101||0.333|TWO_SIDED||||||Mixed Models Analysis|||Latent growth curve models (in multilevel/mixed effects framework, Mplus v8.1) were estimated with maximum likelihood. Simple slopes of DC1 over weeks were calculated for each condition. Models tested whether these slopes differed by condition. This test compared DBT-ER to IP.||||.333
72556400|NCT01648582|144644088|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Fisher Exact|||\<=6.5% Week 26||||<0.001
72556401|NCT01648582|144644088|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Fisher Exact|||\<7.0% Week 52||||<0.001
72556402|NCT01648582|144644088|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002|||||||Fisher Exact|||\<7.0% Week 52||||0.002
72556403|NCT01648582|144644088|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Fisher Exact|||\<=6.5% Week 52||||<0.001
72556404|NCT01648582|144644088|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Fisher Exact|||\<=6.5% Week 52||||<0.001
72618562|NCT01026038|144768104|SUPERIORITY_OR_OTHER|||||||0.297||95.0|||||Fisher Exact|||Redness (Moderate): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/7vPnC/13vPnC.||||0.297
72380242|NCT04626310|144269219|SUPERIORITY||Linear Slope Diff in DC1 DBT-IE-IP|-0.046|STANDARD_ERROR_OF_MEAN|0.097||0.632|TWO_SIDED||||||Mixed Models Analysis|||Latent growth curve models (in multilevel/mixed effects framework, Mplus v8.1) were estimated with maximum likelihood. Simple slopes of DC1 over weeks were calculated for each condition. Models tested whether these slopes differed by condition. This test compared DBT-IE to IP.||||.632
72380243|NCT04626310|144269219|SUPERIORITY||Linear Slope Diff in DC1 DBT-ER-DBT-IE|0.144|STANDARD_ERROR_OF_MEAN|0.107||0.178|TWO_SIDED||||||Mixed Models Analysis|||Latent growth curve models (in multilevel/mixed effects framework, Mplus v8.1) were estimated with maximum likelihood. Simple slopes of DC1 over weeks were calculated for each condition. Models tested whether these slopes differed by condition. This test compared DBT-IE to DBT-ER.||||.178
72380244|NCT04626310|144269219|SUPERIORITY||Linear Slope Diff in DC2 DBT-ER-IP|0.045|STANDARD_ERROR_OF_MEAN|0.112||0.689|TWO_SIDED||||||Mixed Models Analysis|||Latent growth curve models (in multilevel/mixed effects framework, Mplus v8.1) were estimated with maximum likelihood. Simple slopes of DC2 over weeks were calculated for each condition. Models tested whether these slopes differed by condition. This test compared the slope differences DBT-ER to IP.||||.689
72380245|NCT04626310|144269219|SUPERIORITY||Linear Slope Diff in DC2 DBT-IE-IP|-0.011|STANDARD_ERROR_OF_MEAN|0.109||0.917|TWO_SIDED||||||Mixed Models Analysis|||Latent growth curve models (in multilevel/mixed effects framework, Mplus v8.1) were estimated with maximum likelihood. Simple slopes of DC2 over weeks were calculated for each condition. Models tested whether these slopes differed by condition. This test compared the slope differences DBT-IE to IP.||||.917
72380246|NCT04626310|144269219|SUPERIORITY||Linear Slope Diff in DC2 DBT-ER-DBT-IE|0.056|STANDARD_ERROR_OF_MEAN|0.108||0.603|TWO_SIDED||||||Mixed Models Analysis|||Latent growth curve models (in multilevel/mixed effects framework, Mplus v8.1) were estimated with maximum likelihood. Simple slopes of DC2 over weeks were calculated for each condition. Models tested whether these slopes differed by condition. This test compared the slope differences DBT-ER to DBT-IE.||||.603
72380247|NCT04626310|144269220|SUPERIORITY||Other[Quad Slope difference DBT-ER-IP]|0.013|STANDARD_ERROR_OF_MEAN|0.044||0.762|TWO_SIDED||||||Mixed Models Analysis|||Comparisons of Quadratic Slopes (DBT-ER vs. IP) in latent growth curve models (in multilevel/mixed effects framework, Mplus v8.1) with quadratic effects.||||.762
72380248|NCT04626310|144269220|SUPERIORITY||Quad Slope difference DBT-IE-IP|0.034|STANDARD_ERROR_OF_MEAN|0.047||0.478|TWO_SIDED||||||Mixed Models Analysis|||Comparisons of Quadratic Slopes (DBT-IE vs. IP) in latent growth curve models (in multilevel/mixed effects framework, Mplus v8.1) with quadratic effects.||||.478
72380249|NCT04626310|144269220|SUPERIORITY||Quad Slope difference DBT-ER-DBT-IE|-0.089|STANDARD_ERROR_OF_MEAN|0.054||0.705|TWO_SIDED||||||Mixed Models Analysis|||Comparisons of Quadratic Slopes (DBT-ER vs. DBT-IE) in latent growth curve models (in multilevel/mixed effects framework, Mplus v8.1) with quadratic effects.||||.705
72380250|NCT04626310|144269221|SUPERIORITY||Quad slope difference DBT-ER-IP|-0.028|STANDARD_ERROR_OF_MEAN|0.15||0.93|TWO_SIDED||||||Mixed Models Analysis|||Comparisons of Quadratic Slopes (DBT-ER vs. IP) in latent growth curve models (in multilevel/mixed effects framework, Mplus v8.1) with quadratic effects.||||.93
72380251|NCT04626310|144269221|SUPERIORITY||Quad slope difference DBT-IE-IP|-0.029|STANDARD_ERROR_OF_MEAN|0.145||0.836|TWO_SIDED||||||Mixed Models Analysis|||Comparisons of Quadratic Slopes (DBT-IE vs. IP) in latent growth curve models (in multilevel/mixed effects framework, Mplus v8.1) with quadratic effects.||||.836
72380252|NCT04626310|144269221|SUPERIORITY||Quad slope difference DBT-ER-DBT-IE|0.001|STANDARD_ERROR_OF_MEAN|0.145||0.994|TWO_SIDED||||||Mixed Models Analysis|||Comparisons of Quadratic Slopes (DBT-IE vs. IP) in latent growth curve models (in multilevel/mixed effects framework, Mplus v8.1) with quadratic effects.||||.994
72556405|NCT01648582|144644089|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.24||||0.177|TWO_SIDED|95.0|-0.11|0.59|||Mixed Models Analysis|||Week 26||0.59|-0.11|0.177
72556406|NCT01648582|144644089|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.88|||<|0.001|TWO_SIDED|95.0|0.53|1.23|||Mixed Models Analysis|||Week 26||1.23|0.53|<0.001
72380253|NCT04626310|144269222|SUPERIORITY||Quad slope diff in DC1 DBT-ER-IP|0.013|STANDARD_ERROR_OF_MEAN|0.013||0.313|TWO_SIDED||||||Mixed Models Analysis|||Latent growth curve models (in multilevel/mixed effects framework, Mplus v8.1) were estimated with maximum likelihood. Simple slopes of DC1 over weeks were calculated for each condition. Models tested whether these slopes differed by condition. This test compared the quadratic effects differed DBT-ER to IP.||||.313
72380254|NCT04626310|144269222|SUPERIORITY||Quad Slope in DC1 DBT-IE-IP|0.003|STANDARD_ERROR_OF_MEAN|0.01||0.747|TWO_SIDED||||||Mixed Models Analysis|||Latent growth curve models (in multilevel/mixed effects framework, Mplus v8.1) were estimated with maximum likelihood. Simple slopes of DC1 over weeks were calculated for each condition. Models tested whether these slopes differed by condition. This test compared the quadratic effects differed DBT-IE to IP.||||.747
72380255|NCT04626310|144269222|SUPERIORITY||Quad slope diff in DC1 DBT-ER-DBT-IE|0.009|STANDARD_ERROR_OF_MEAN|0.012||0.444|TWO_SIDED||||||Mixed Models Analysis|||Latent growth curve models (in multilevel/mixed effects framework, Mplus v8.1) were estimated with maximum likelihood. Simple slopes of DC1 over weeks were calculated for each condition. Models tested whether these slopes differed by condition. This test compared the quadratic effects differed DBT-ER to DBT-IE.||||.444
72380256|NCT02278341|144269223|NON_INFERIORITY|Non Inferiority, Margin = -0.75|LSM Difference|0.235|||<|0.001|TWO_SIDED|95.0|0.132|0.339||p-value for non-inferiority test based on 1-sided significance level.|Mixed Models Analysis|||The model includes treatment arm, region, CV History, previous ESA treatment, visits and visit by treatment as categorical variables and baseline Hb and baseline Hb by visit as continuous variable.||0.339|0.132|<0.001
72556407|NCT01648582|144644089|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.12||||0.518|TWO_SIDED|95.0|-0.25|0.5|||Mixed Models Analysis|||Week 52||0.50|-0.25|0.518
72556408|NCT01648582|144644089|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.82|||<|0.001|TWO_SIDED|95.0|0.45|1.2|||Mixed Models Analysis|||Week 52||1.20|0.45|<0.001
72556409|NCT01648582|144644090|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.65|||<|0.001|TWO_SIDED|95.0|0.42|0.88|||Mixed Models Analysis|||Morning pre-meal, Week 26||0.88|0.42|<0.001
72556410|NCT01648582|144644090|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.94|||<|0.001|TWO_SIDED|95.0|0.71|1.17|||Mixed Models Analysis|||Morning pre-meal, Week 26||1.17|0.71|<0.001
72556411|NCT01648582|144644090|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.49||||0.024|TWO_SIDED|95.0|-0.92|-0.07|||Mixed Models Analysis|||Morning 2-hours post-meal, Week 26||-0.07|-0.92|0.024
72380257|NCT02278341|144269224|NON_INFERIORITY|Non-Inferiority, Margin = -0.75|LSM Difference|0.171|||<|0.001|TWO_SIDED|95.0|0.082|0.261||p-value for non-inferiority test based on 1-sided significance level.|ANCOVA|||The model includes treatment arm, region, CV History, previous ESA treatment as categorical variables and baseline Hb as continuous variable. Statistical analysis used was ANCOVA model with multiple imputations (MI). Missing hemoglobin data was imputed for each treatment relying on non-missing data from all participants within each treatment group using the MCMC imputation model.||0.261|0.082|<0.001
72380258|NCT02278341|144269225|NON_INFERIORITY|Non-inferiority of roxadustat versus ESA (the non-inferiority margin for the difference between groups is -15%).|Difference of Percentages|2.3|||<|0.05|TWO_SIDED|95.0|-2.9|7.6||p-value for non-inferiority test based on 1-sided significance level.|Miettinen and Nurminen|||A generalized linear model was used to estimate the difference in response rates between the arms, as an approximation for the Miettinen and Nurminen method, adjusting for following covariates: region, previous ESA treatment, cardiovascular history and baseline Hb as categorical variables.||7.6|-2.9|<0.05
72380259|NCT02278341|144269226|SUPERIORITY||LSM Difference|-0.377|||<|0.001|TWO_SIDED|95.0|-0.451|-0.304||p-value for superiority test based on 2-sided significance level|Mixed Models Analysis|||The model includes treatment arm, region, CV History, previous ESA treatment, visits and visit by treatment as categorical variables and baseline LDL, baseline Hb as continuous variables.||-0.304|-0.451|<0.001
72380260|NCT02278341|144269227|SUPERIORITY||LSM Difference|-31.9|||<|0.001|TWO_SIDED|95.0|-41.4|-22.4||p-value for superiority test based on 2-sided significance level|ANCOVA|||The model includes treatment arm, region, CV History, previous ESA treatment as categorical variables and baseline Hb as continuous variable.||-22.4|-41.4|<0.001
72380261|NCT02278341|144269228|NON_INFERIORITY|The margin for non-inferiority was -3.|LSM Difference|0.205|||<|0.05|TWO_SIDED|95.0|-0.649|1.059||p-value for non-inferiority test based on 1-sided significance level|Mixed Models Analysis|||The model includes treatment arm, region, CV History, previous ESA treatment, visits (week 8, week 12, week 28) and visit by treatment as categorical variables, and baseline SF-36 PF, baseline Hb as continuous variables.||1.059|-0.649|<0.05
72380262|NCT02278341|144269229|NON_INFERIORITY|The margin for non-inferiority was -3.|LSM Difference|0.856|||<|0.05|TWO_SIDED|95.0|-0.115|1.828|||Mixed Models Analysis|||The model includes treatment arm, region, CV History, previous ESA treatment, visits (week 8, week 12, week 28) and visit by treatment as categorical variables, and baseline SF-36 VT, baseline Hb as continuous variables.||1.828|-0.115|<0.05
72380263|NCT02278341|144269230|NON_INFERIORITY|The margin for non-inferiority was 1.|LSM Difference|-0.849|||<|0.05|TWO_SIDED|95.0|-1.971|0.273||p-value for non-inferiority test based on 1-sided significance level|Mixed Models Analysis|||The model includes treatment arm, region, CV History, previous ESA treatment, visits and visit by treatment as categorical variables, and baseline MAP, baseline Hb as continuous variables.||0.273|-1.971|<0.05
72380264|NCT02278341|144269231|NON_INFERIORITY|Non-inferiority (hazard ratio margin of 1.3).|Hazard Ratio (HR)|0.924|||<|0.05|TWO_SIDED|95.0|0.669|1.276||p-value for non-inferiority test based on 1-sided significance level.|Regression, Cox|||Hazard Ratio was calculated using stratified Cox Proportional Hazards regression stratifying on region, CV history, previous ESA treatment, and adjusting on Hb at baseline as continuous covariate. Non-inferiority was declared if the upper bound of the 95% CI is below 1.3.||1.276|0.669|<0.05
72380265|NCT02278341|144269232|SUPERIORITY||LSM Difference|-0.579|||=|0.308|TWO_SIDED|95.0|-1.694|0.536||p-value for superiority test based on 2-sided significance level.|Mixed Models Analysis|||The model includes treatment arm, region, CV History, previous ESA treatment, visits and visit by treatment as categorical variables, and baseline MAP, baseline Hb as continuous variables.||0.536|-1.694|=0.308
72380266|NCT02278341|144269233|SUPERIORITY||Hazard Ratio (HR)|0.915|||=|0.582|TWO_SIDED|95.0|0.668|1.254||p-value for superiority test based on 2-sided significance level.|Regression, Cox|||Hazard Ratio was calculated using stratified Cox Proportional Hazards regression stratifying on region, CV history, previous ESA treatment, and adjusting on Hb at baseline as continuous covariate. Superiority was declared if the upper bound of the 95% CI is lower than 1.||1.254|0.668|=0.582
72380267|NCT02278341|144269234|SUPERIORITY||Difference of Percentages|1.4|||=|0.609|TWO_SIDED|95.0|-3.8|6.5||p-value for superiority test based on 2-sided significance level|Miettinen and Nurminen method|||A generalized linear model was used to estimate the difference in response rates between the arms, as an approximation for the Miettinen and Nurminen method, adjusting for following covariates: region, previous ESA treatment, cardiovascular history and baseline Hb as categorical variables.||6.5|-3.8|=0.609
72380268|NCT02278341|144269235|SUPERIORITY||LSM Difference|0.164|||<|0.001|TWO_SIDED|95.0|0.072|0.256||p-value for superiority test based on 2-sided significance level.|Mixed Models Analysis|||Week 1- The model included treatment, visit, visit by treatment interaction, Previous ESA Treatment, region and history of CV disease as fixed class factors and baseline Hb as continuous covariates.||0.256|0.072|<0.001
72493940|NCT03178487|144516783|SUPERIORITY|To preserve the overall type I error rate at α=0.05 level, a step-down approach was used to test the primary and multiplicity-controlled key secondary endpoints. The testing began with the primary endpoint at α=0.05 and continued conditional on significance of higher-ranked endpoint. The testing sequence included a group of endpoints tested by the Hochberg procedure, including BASMI(lin); within the group, the allocated α was adjusted based on the magnitude of p values.|LS Mean Difference|-0.22||||0.03|TWO_SIDED|95.0|-0.43|-0.02|||ANCOVA|ANCOVA model including treatment and Screening hsCRP level as fixed factors and Baseline value as covariate.|Treatment difference = Upadacitinib - Placebo|||-0.02|-0.43|0.030
72493941|NCT03178487|144516784|SUPERIORITY|To preserve the overall type I error rate at α=0.05 level, a step-down approach was used to test the primary and multiplicity-controlled key secondary endpoints. The testing began with the primary endpoint at α=0.05 and continued conditional on significance of higher-ranked endpoint. The testing sequence included a group of endpoints tested by the Hochberg procedure, including MASES; within the group, the allocated α was adjusted based on the magnitude of p values.|LS Mean Difference|-0.84||||0.049|TWO_SIDED|95.0|-1.68|0.0|||Mixed Effect Model Repeated Measurement|MMRM model includes treatment, visit, treatment-by-visit interaction as fixed effects and Screening hsCRP level and Baseline value as covariates.|Treatment difference = Upadacitinib - Placebo|||-0.00|-1.68|0.049
72556412|NCT01648582|144644090|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.11||||0.617|TWO_SIDED|95.0|-0.53|0.32|||Mixed Models Analysis|||Morning 2-hours post-meal, Week 26||0.32|-0.53|0.617
72380269|NCT02278341|144269235|SUPERIORITY||LSM Difference|0.443|||<|0.001|TWO_SIDED|95.0|0.339|0.546||p-value for superiority test based on 2-sided significance level.|Mixed Models Analysis|||Week 2- The model included treatment, visit, visit by treatment interaction, Previous ESA Treatment, region and history of CV disease as fixed class factors and baseline Hb as continuous covariates.||0.546|0.339|<0.001
72380270|NCT02278341|144269235|SUPERIORITY||LSM Difference|0.561|||<|0.001|TWO_SIDED|95.0|0.451|0.672||p-value for superiority test based on 2-sided significance level.|Mixed Models Analysis|||Week 3 - The model included treatment, visit, visit by treatment interaction, Previous ESA Treatment, region and history of CV disease as fixed class factors and baseline Hb as continuous covariates.||0.672|0.451|<0.001
72380271|NCT02278341|144269235|SUPERIORITY||LSM Difference|0.708|||<|0.001||95.0|0.588|0.828||p-value for superiority test based on 2-sided significance level.|Mixed Models Analysis|||Week 4 - The model included treatment, visit, visit by treatment interaction, Previous ESA Treatment, region and history of CV disease as fixed class factors and baseline Hb as continuous covariates.||0.828|0.588|<0.001
72380272|NCT02278341|144269235|SUPERIORITY||LSM Difference|0.768|||<|0.001|TWO_SIDED|95.0|0.645|0.89||p-value for superiority test based on 2-sided significance level.|Mixed Models Analysis|||Week 5 - The model included treatment, visit, visit by treatment interaction, Previous ESA Treatment, region and history of CV disease as fixed class factors and baseline Hb as continuous covariates.||0.890|0.645|<0.001
72380273|NCT02278341|144269235|SUPERIORITY||LSM Difference|0.729|||<|0.001|TWO_SIDED|95.0|0.604|0.855||p-value for superiority test based on 2-sided significance level.|Mixed Models Analysis|||Week 6 - The model included treatment, visit, visit by treatment interaction, Previous ESA Treatment, region and history of CV disease as fixed class factors and baseline Hb as continuous covariates.||0.855|0.604|<0.001
72380274|NCT02278341|144269235|SUPERIORITY||LSM Difference|0.729|||<|0.001|TWO_SIDED|95.0|0.603|0.856||p-value for superiority test based on 2-sided significance level.|Mixed Models Analysis|||Week 7 - The model included treatment, visit, visit by treatment interaction, Previous ESA Treatment, region and history of CV disease as fixed class factors and baseline Hb as continuous covariates.||0.856|0.603|<0.001
72380275|NCT02278341|144269235|SUPERIORITY||LSM Difference|0.7|||<|0.001|TWO_SIDED|95.0|0.574|0.826||p-value for superiority test based on 2-sided significance level.|Mixed Models Analysis|||Week 8 - The model included treatment, visit, visit by treatment interaction, Previous ESA Treatment, region and history of CV disease as fixed class factors and baseline Hb as continuous covariates.||0.826|0.574|<0.001
72380276|NCT02278341|144269235|SUPERIORITY||LSM Difference|0.659|||<|0.001|TWO_SIDED|95.0|0.53|0.788||p-value for superiority test based on 2-sided significance level.|Mixed Models Analysis|||Week 10 - The model included treatment, visit, visit by treatment interaction, Previous ESA Treatment, region and history of CV disease as fixed class factors and baseline Hb as continuous covariates.||0.788|0.530|<0.001
72556413|NCT01648582|144644090|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.35||||0.055|TWO_SIDED|95.0|-0.7|0.01|||Mixed Models Analysis|||Mid-day pre-meal, Week 26||0.01|-0.70|0.055
72618563|NCT01026038|144768104|SUPERIORITY_OR_OTHER|||||||0.145||95.0|||||Fisher Exact|||Redness (Moderate): Fisher exact test, 2-sided was used. Pairwise comparison was made between 7vPnC/7vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.||||0.145
72380277|NCT02278341|144269235|SUPERIORITY||LSM Difference|0.593|||<|0.001|TWO_SIDED|95.0|0.459|0.727||p-value for superiority test based on 2-sided significance level.|Mixed Models Analysis|||Week 12 - The model included treatment, visit, visit by treatment interaction, Previous ESA Treatment, region and history of CV disease as fixed class factors and baseline Hb as continuous covariates.||0.727|0.459|<0.001
72380278|NCT02278341|144269235|SUPERIORITY||LSM Difference|0.503|||<|0.001|TWO_SIDED|95.0|0.366|0.64||p-value for superiority test based on 2-sided significance level.|Mixed Models Analysis|||Week 14 - The model included treatment, visit, visit by treatment interaction, Previous ESA Treatment, region and history of CV disease as fixed class factors and baseline Hb as continuous covariates.||0.640|0.366|<0.001
72380279|NCT02278341|144269235|SUPERIORITY||LSM Difference|0.369|||<|0.001|TWO_SIDED|95.0|0.229|0.51||p-value for superiority test based on 2-sided significance level.|Mixed Models Analysis|||Week 16 - The model included treatment, visit, visit by treatment interaction, Previous ESA Treatment, region and history of CV disease as fixed class factors and baseline Hb as continuous covariates.||0.510|0.229|<0.001
72380280|NCT02278341|144269235|SUPERIORITY||LSM Difference|0.363|||<|0.001|TWO_SIDED|95.0|0.23|0.496||p-value for superiority test based on 2-sided significance level.|Mixed Models Analysis|||Week 18 - The model included treatment, visit, visit by treatment interaction, Previous ESA Treatment, region and history of CV disease as fixed class factors and baseline Hb as continuous covariates.||0.496|0.230|<0.001
72380281|NCT02278341|144269235|SUPERIORITY||LSM Difference|0.284|||<|0.001|TWO_SIDED|95.0|0.154|0.414||p-value for superiority test based on 2-sided significance level.|Mixed Models Analysis|||Week 20 - The model included treatment, visit, visit by treatment interaction, Previous ESA Treatment, region and history of CV disease as fixed class factors and baseline Hb as continuous covariates.||0.414|0.154|<0.001
72380282|NCT02278341|144269235|SUPERIORITY||LSM Difference|0.197|||=|0.003|TWO_SIDED|95.0|0.065|0.329||p-value for superiority test based on 2-sided significance level.|Mixed Models Analysis|||Week 22 - The model included treatment, visit, visit by treatment interaction, Previous ESA Treatment, region and history of CV disease as fixed class factors and baseline Hb as continuous covariates.||0.329|0.065|=0.003
72380283|NCT02278341|144269235|SUPERIORITY||LSM Difference|0.187|||=|0.004|TWO_SIDED|95.0|0.059|0.316||p-value for superiority test based on 2-sided significance level.|Mixed Models Analysis|||Week 24 - The model included treatment, visit, visit by treatment interaction, Previous ESA Treatment, region and history of CV disease as fixed class factors and baseline Hb as continuous covariates.||0.316|0.059|=0.004
72380284|NCT02278341|144269235|SUPERIORITY||LSM Difference|0.243|||<|0.001|TWO_SIDED|95.0|0.113|0.373||p-value for superiority test based on 2-sided significance level.|Mixed Models Analysis|||Week 26 - The model included treatment, visit, visit by treatment interaction, Previous ESA Treatment, region and history of CV disease as fixed class factors and baseline Hb as continuous covariates.||0.373|0.113|<0.001
72556414|NCT01648582|144644090|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.03||||0.855|TWO_SIDED|95.0|-0.32|0.39|||Mixed Models Analysis|||Mid-day pre-meal, Week 26||0.39|-0.32|0.855
72556415|NCT01648582|144644090|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-1.05|||<|0.001|TWO_SIDED|95.0|-1.46|-0.64|||Mixed Models Analysis|||Mid-day 2-hours post-meal, Week 26||-0.64|-1.46|<0.001
72380285|NCT02278341|144269235|SUPERIORITY||LSM Difference|0.207|||=|0.002|TWO_SIDED|95.0|0.074|0.34||p-value for superiority test based on 2-sided significance level.|Mixed Models Analysis|||Week 28 - The model included treatment, visit, visit by treatment interaction, Previous ESA Treatment, region and history of CV disease as fixed class factors and baseline Hb as continuous covariates.||0.340|0.074|=0.002
72380286|NCT02278341|144269235|SUPERIORITY||LSM Difference|0.227|||<|0.001|TWO_SIDED|95.0|0.096|0.358||p-value for superiority test based on 2-sided significance level.|Mixed Models Analysis|||Week 30 - The model included treatment, visit, visit by treatment interaction, Previous ESA Treatment, region and history of CV disease as fixed class factors and baseline Hb as continuous covariates.||0.358|0.096|<0.001
72380287|NCT02278341|144269235|SUPERIORITY||LSM Difference|0.199|||=|0.004|TWO_SIDED|95.0|0.064|0.334|||Mixed Models Analysis|p-value for superiority test based on 2-sided significance level.||Week 32 - The model included treatment, visit, visit by treatment interaction, Previous ESA Treatment, region and history of CV disease as fixed class factors and baseline Hb as continuous covariates.||0.334|0.064|=0.004
72380288|NCT02278341|144269235|SUPERIORITY||LSM Difference|0.279|||<|0.001||95.0|0.15|0.409||p-value for superiority test based on 2-sided significance level.|Mixed Models Analysis|||Week 34 - The model included treatment, visit, visit by treatment interaction, Previous ESA Treatment, region and history of CV disease as fixed class factors and baseline Hb as continuous covariates.||0.409|0.150|<0.001
72380289|NCT02278341|144269235|SUPERIORITY||LSM Difference|0.256|||<|0.001|TWO_SIDED|95.0|0.121|0.391||p-value for superiority test based on 2-sided significance level.|Mixed Models Analysis|||Week 36- The model included treatment, visit, visit by treatment interaction, Previous ESA Treatment, region and history of CV disease as fixed class factors and baseline Hb as continuous covariates.||0.391|0.121|<0.001
72380290|NCT02278341|144269235|SUPERIORITY||LSM Difference|0.136|||=|0.06|TWO_SIDED|95.0|-0.006|0.277||p-value for superiority test based on 2-sided significance level.|Mixed Models Analysis|||Week 40 - The model included treatment, visit, visit by treatment interaction, Previous ESA Treatment, region and history of CV disease as fixed class factors and baseline Hb as continuous covariates.||0.277|-0.006|=0.060
72380291|NCT02278341|144269235|SUPERIORITY||LSM Difference|0.082|||=|0.293|TWO_SIDED|95.0|-0.071|0.236||p-value for superiority test based on 2-sided significance level.|Mixed Models Analysis|||Week 44 - The model included treatment, visit, visit by treatment interaction, Previous ESA Treatment, region and history of CV disease as fixed class factors and baseline Hb as continuous covariates.||0.236|-0.071|=0.293
72380292|NCT02278341|144269235|SUPERIORITY||LSM Difference|0.027|||=|0.723|TWO_SIDED|95.0|-0.123|0.177||p-value for superiority test based on 2-sided significance level.|Mixed Models Analysis|||Week 48 - The model included treatment, visit, visit by treatment interaction, Previous ESA Treatment, region and history of CV disease as fixed class factors and baseline Hb as continuous covariates.||0.177|-0.123|=0.723
72380293|NCT02278341|144269235|SUPERIORITY||LSM Difference|0.199|||=|0.009|TWO_SIDED|95.0|0.049|0.348||p-value for superiority test based on 2-sided significance level.|Mixed Models Analysis|||Week 52 - The model included treatment, visit, visit by treatment interaction, Previous ESA Treatment, region and history of CV disease as fixed class factors and baseline Hb as continuous covariates.||0.348|0.049|=0.009
72380294|NCT02278341|144269235|SUPERIORITY||LSM Difference|0.147|||=|0.056|TWO_SIDED|95.0|-0.004|0.298||p-value for superiority test based on 2-sided significance level.|Mixed Models Analysis|||Week 56 - The model included treatment, visit, visit by treatment interaction, Previous ESA Treatment, region and history of CV disease as fixed class factors and baseline Hb as continuous covariates.||0.298|-0.004|=0.056
72380295|NCT02278341|144269235|SUPERIORITY||LSM Difference|0.196|||=|0.01|TWO_SIDED|95.0|0.047|0.346||p-value for superiority test based on 2-sided significance level.|Mixed Models Analysis|||Week 60 - The model included treatment, visit, visit by treatment interaction, Previous ESA Treatment, region and history of CV disease as fixed class factors and baseline Hb as continuous covariates.||0.346|0.047|=0.010
72433626|NCT00991276|144380378|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|10.69|STANDARD_ERROR_OF_MEAN|7.71||0.1677|TWO_SIDED|95.0|-4.56|25.95||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||25.95|-4.56|0.1677
72556416|NCT01648582|144644090|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.6||||0.004|TWO_SIDED|95.0|-1.01|-0.19|||Mixed Models Analysis|||Mid-day 2-hours post-meal, Week 26||-0.19|-1.01|0.004
72380296|NCT02278341|144269235|SUPERIORITY||LSM Difference|0.275|||<|0.001|TWO_SIDED|95.0|0.123|0.427||p-value for superiority test based on 2-sided significance level.|Mixed Models Analysis|||Week 64 - The model included treatment, visit, visit by treatment interaction, Previous ESA Treatment, region and history of CV disease as fixed class factors and baseline Hb as continuous covariates.||0.427|0.123|<0.001
72380297|NCT02278341|144269235|SUPERIORITY||LSM Difference|0.206|||=|0.006|TWO_SIDED|95.0|0.059|0.353||p-value for superiority test based on 2-sided significance level.|Mixed Models Analysis|||Week 68 - The model included treatment, visit, visit by treatment interaction, Previous ESA Treatment, region and history of CV disease as fixed class factors and baseline Hb as continuous covariates.||0.353|0.059|=0.006
72380298|NCT02278341|144269235|SUPERIORITY||LSM Difference|0.118|||=|0.127|TWO_SIDED|95.0|-0.033|0.269||p-value for superiority test based on 2-sided significance level.|Mixed Models Analysis|||Week 72 - The model included treatment, visit, visit by treatment interaction, Previous ESA Treatment, region and history of CV disease as fixed class factors and baseline Hb as continuous covariates.||0.269|-0.033|=0.127
72556417|NCT01648582|144644090|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.63|||<|0.001|TWO_SIDED|95.0|-0.97|-0.29|||Mixed Models Analysis|||Evening pre-meal, Week 26||-0.29|-0.97|<0.001
72556418|NCT01648582|144644090|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.12||||0.489|TWO_SIDED|95.0|-0.45|0.22|||Mixed Models Analysis|||Evening pre-meal, Week 26||0.22|-0.45|0.489
72556419|NCT01648582|144644090|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.89|||<|0.001|TWO_SIDED|95.0|-1.3|-0.48|||Mixed Models Analysis|||Evening 2-hours post-meal, Week 26||-0.48|-1.30|<0.001
72556420|NCT01648582|144644090|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.47||||0.024|TWO_SIDED|95.0|-0.88|-0.06|||Mixed Models Analysis|||Evening 2-hours post-meal, Week 26||-0.06|-0.88|0.024
72380299|NCT02278341|144269235|SUPERIORITY||LSM Difference|0.211|||=|0.01|TWO_SIDED|95.0|0.051|0.371||p-value for superiority test based on 2-sided significance level.|Mixed Models Analysis|||Week 76 - The model included treatment, visit, visit by treatment interaction, Previous ESA Treatment, region and history of CV disease as fixed class factors and baseline Hb as continuous covariates.||0.371|0.051|=0.010
72380300|NCT02278341|144269235|SUPERIORITY||LSM Difference|0.102|||=|0.191|TWO_SIDED|95.0|-0.051|0.255||p-value for superiority test based on 2-sided significance level.|Mixed Models Analysis|||Week 80 - The model included treatment, visit, visit by treatment interaction, Previous ESA Treatment, region and history of CV disease as fixed class factors and baseline Hb as continuous covariates.||0.255|-0.051|=0.191
72380301|NCT02278341|144269235|SUPERIORITY||LSM Difference|0.192|||=|0.018|TWO_SIDED|95.0|0.033|0.351||p-value for superiority test based on 2-sided significance level.|Mixed Models Analysis|||Week 84 - The model included treatment, visit, visit by treatment interaction, Previous ESA Treatment, region and history of CV disease as fixed class factors and baseline Hb as continuous covariates.||0.351|0.033|=0.018
72380302|NCT02278341|144269235|SUPERIORITY||LSM Difference|0.044|||=|0.576|TWO_SIDED|95.0|-0.111|0.2||p-value for superiority test based on 2-sided significance level.|Mixed Models Analysis|||Week 88 - The model included treatment, visit, visit by treatment interaction, Previous ESA Treatment, region and history of CV disease as fixed class factors and baseline Hb as continuous covariates.||0.200|-0.111|=0.576
72380303|NCT02278341|144269235|SUPERIORITY||LSM Difference|0.203|||=|0.017|TWO_SIDED|95.0|0.037|0.369||p-value for superiority test based on 2-sided significance level.|Mixed Models Analysis|||Week 92 - The model included treatment, visit, visit by treatment interaction, Previous ESA Treatment, region and history of CV disease as fixed class factors and baseline Hb as continuous covariates.||0.369|0.037|=0.017
72380304|NCT02278341|144269235|SUPERIORITY||LSM Difference|0.184|||=|0.019|TWO_SIDED|95.0|0.031|0.338||p-value for superiority test based on 2-sided significance level.|Mixed Models Analysis|||Week 96 - The model included treatment, visit, visit by treatment interaction, Previous ESA Treatment, region and history of CV disease as fixed class factors and baseline Hb as continuous covariates.||0.338|0.031|=0.019
72380305|NCT02278341|144269235|SUPERIORITY||LSM Difference|0.164|||=|0.056||95.0|-0.004|0.333||p-value for superiority test based on 2-sided significance level.|Mixed Models Analysis|||Week 100 - The model included treatment, visit, visit by treatment interaction, Previous ESA Treatment, region and history of CV disease as fixed class factors and baseline Hb as continuous covariates.||0.333|-0.004|=0.056
72380306|NCT02278341|144269235|SUPERIORITY||LSM Difference|0.099|||=|0.267|TWO_SIDED|95.0|-0.076|0.273||p-value for superiority test based on 2-sided significance level.|Mixed Models Analysis|||Week 104 - The model included treatment, visit, visit by treatment interaction, Previous ESA Treatment, region and history of CV disease as fixed class factors and baseline Hb as continuous covariates.||0.273|-0.076|=0.267
72380307|NCT02278341|144269236|SUPERIORITY||LSM Difference|0.237|||<|0.001|TWO_SIDED|95.0|0.127|0.347||p-value for superiority test based on 2-sided significance level.|Mixed Models Analysis|||Weeks 28-36 - The model includes treatment arm, region, CV History, previous ESA treatment, visits and visit by treatment as categorical variables and baseline Hb as continuous variable.||0.347|0.127|<0.001
72380308|NCT02278341|144269236|SUPERIORITY||LSM Difference|0.105|||=|0.086|TWO_SIDED|95.0|-0.015|0.225||p-value for superiority test based on 2-sided significance level|Mixed Models Analysis|||Weeks 44-52 - The model includes treatment arm, region, CV History, previous ESA treatment, visits and visit by treatment as categorical variables and baseline Hb as continuous variable.||0.225|-0.015|=0.086
72380309|NCT02278341|144269236|SUPERIORITY||LSM Difference|0.149|||=|0.031|TWO_SIDED|95.0|0.014|0.284||p-value for superiority test based on 2-sided significance level|Mixed Models Analysis|||Weeks 96-104 - The model includes treatment arm, region, CV History, previous ESA treatment, visits and visit by treatment as categorical variables and baseline Hb as continuous variable.||0.284|0.014|=0.031
72504918|NCT01272180|144540895|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The immune response of ABCWY+OMV group was considered to be non-inferior to that of ACWY group if the lower limit of the two-sided 95% confidence interval on the difference between groups in percentage of subjects with seroresponse is greater than -10% for each of A, C, W-135and Y serogroups, at 30 days after the last vaccination.|Group Difference % (ABCWY+OMV - ACWY)|15.0|||||TWO_SIDED|95.0|0.0|30.0||||||Non-inferiority of seroresponse against N.meningitidis serogroup W-135 of two doses of ABCWY+OMV combination vaccine to that of one dose of MenACWY vaccine.||30|0|
72380310|NCT02278341|144269237|SUPERIORITY||LSM Difference|0.235|||<|0.001|TWO_SIDED|95.0|0.125|0.346|||Mixed Models Analysis|||Weeks 28-36 - The model includes treatment arm, region, CV History, previous ESA treatment, visits and visit by treatment as categorical variables and baseline Hb as continuous variable.||0.346|0.125|<0.001
72380311|NCT02278341|144269237|SUPERIORITY||LSM Difference|0.104|||=|0.11|TWO_SIDED|95.0|-0.024|0.232|||Mixed Models Analysis|||Weeks 44-52 - The model includes treatment arm, region, CV History, previous ESA treatment, visits and visit by treatment as categorical variables and baseline Hb as continuous variable.||0.232|-0.024|=0.110
72380312|NCT02278341|144269237|SUPERIORITY||LSM Difference|0.149|||=|0.036|TWO_SIDED|95.0|0.01|0.288|||Mixed Models Analysis|||Weeks 96-104 - The model includes treatment arm, region, CV History, previous ESA treatment, visits and visit by treatment as categorical variables and baseline Hb as continuous variable.||0.288|0.010|=0.036
72380313|NCT02278341|144269242|SUPERIORITY||Hazard Ratio (HR)|1.154|||=|0.164|TWO_SIDED|95.0|0.943|1.411||p-value for superiority test based on 2-sided significance level|Regression, Cox|||Hazard Ratio was calculated using stratified Cox Proportional Hazards regression stratifying on region, CV history, previous ESA treatment and adjusting on Hb at baseline as continuous covariate. Superiority was declared if the upper bound of the 95% CI was below 1.0.||1.411|0.943|=0.164
72380314|NCT02278341|144269243|SUPERIORITY||Hazard Ratio (HR)|0.979|||=|0.917|TWO_SIDED|95.0|0.656|1.462|||Regression, Cox|||Hazard Ratio was calculated using stratified Cox Proportional Hazards regression stratifying on region, CV history, previous ESA treatment and adjusting on Hb at baseline as continuous covariate. Superiority was declared if the upper bound of the 95% CI was below 1.0.||1.462|0.656|=0.917
72380315|NCT02278341|144269244|SUPERIORITY||Hazard Ratio (HR)|0.867|||=|0.501|TWO_SIDED|95.0|0.573|1.313||p-value for superiority test based on 2-sided significance level|Regression, Cox|||Hazard Ratio was calculated using stratified Cox Proportional Hazards regression stratifying on region, CV history, previous ESA treatment, and adjusting on Hb at baseline as continuous covariate. Superiority was declared if the upper bound of the 95% CI was below 1.0.||1.313|0.573|=0.501
72380316|NCT02278341|144269245|SUPERIORITY||LSM Difference|-0.006|||=|0.507|TWO_SIDED|95.0|-0.02|0.01||p-value for superiority test based on 2-sided significance level|ANCOVA|||The model included treatment arm, region, CV History, previous ESA treatment as categorical variables and baseline Hb as continuous variable.||0.01|-0.02|=0.507
72380317|NCT02278341|144269246|SUPERIORITY||LSM Difference|0.132|||=|0.949|TWO_SIDED|95.0|-3.9|4.16|||ANCOVA|||The model included treatment arm, region, CV History, previous ESA treatment as categorical variables and baseline Hb as continuous variable.||4.16|-3.90|=0.949
72380318|NCT02278341|144269247|SUPERIORITY||Hazard Ratio (HR)|0.368|||<|0.001|TWO_SIDED|95.0|0.291|0.465|||Regression, Cox|||Hazard Ratio was calculated using stratified Cox Proportional Hazards regression stratifying on region, CV history, previous ESA treatment and adjusting on Hb at baseline as continuous covariate. Superiority was declared if the upper bound of the 95% CI was below 1.0.||0.465|0.291|<0.001
72380319|NCT02278341|144269248|SUPERIORITY||LSM Difference|-35.1|||<|0.001|TWO_SIDED|95.0|-51.8|-18.4|||ANCOVA|||Weeks 37-52 - Participants with no or missing medication records of IV Iron had their monthly IV Iron use set to 0 mg. The model includes treatment arm, region, CV History, previous ESA treatment as categorical variables and baseline Hb as continuous variable.||-18.4|-51.8|<0.001
72380320|NCT02278341|144269248|SUPERIORITY||LSM Difference|-48.7|||<|0.001|TWO_SIDED|95.0|-70.3|-27.0|||ANCOVA|||Weeks 53-104 - Participants with no or missing medication records of IV Iron had their monthly IV Iron use set to 0 mg. The model includes treatment arm, region, CV History, previous ESA treatment as categorical variables and baseline Hb as continuous variable.||-27.0|-70.3|<0.001
72380321|NCT02278341|144269258|SUPERIORITY||LSM Difference|0.521|||=|0.161|TWO_SIDED|95.0|-0.208|1.25||p-value for superiority test based on 2-sided significance level|Mixed Models Analysis|||The model includes treatment, visit, visit by treatment interaction, Previous ESA Treatment, region and history of CV disease as fixed class factors and baseline SF-36 PCS, baseline Hb, as continuous covariates.||1.250|-0.208|=0.161
72380322|NCT02278341|144269259|SUPERIORITY||LSM Difference|0.126|||=|0.845|TWO_SIDED|95.0|-1.135|1.387||p-value for superiority test based on 2-sided significance level|Mixed Models Analysis|||The model includes treatment, visit, visit by treatment interaction, Previous ESA Treatment, region and history of CV disease as fixed class factors and baseline FACT-An Ans, baseline Hb, as continuous covariates.||1.387|-1.135|=0.845
72380323|NCT02278341|144269260|SUPERIORITY||LSM Difference|-0.128|||=|0.922|TWO_SIDED|95.0|-2.703|2.447||p-value for superiority test based on 2-sided significance level|Mixed Models Analysis|||The model includes treatment, visit, visit by treatment interaction, Previous ESA Treatment, region and history of CV disease as fixed class factors and baseline FACT-An Ans, baseline Hb, as continuous covariates.||2.447|-2.703|=0.922
72380324|NCT02604017|144269268|NON_INFERIORITY|The noninferiority of the rate of SVR12 for the 12-week treatment group as compared with the historical rate was analyzed; the lower confidence bound of the 2-sided 95% confidence interval (95% CI) for the percentage of participants with SVR12 must exceed 91% to achieve noninferiority.|Percentage of Participants|99.7|||||TWO_SIDED|95.0|99.1|100.0||||||Based on a 2-sided significance level of 0.05 and an underlying rate of ≥97% in the 12-week arm, 270 participants provides \>90% power to demonstrate noninferiority of the 12-week arm to the historical control rate for HCV GT1 subjects who are treatment-naïve or treated with pegIFN/RBV (based on the normal approximation of a single binomial proportion in a one-sample test for superiority).||100.0|99.1|
72556421|NCT01648582|144644090|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.79|||<|0.001|TWO_SIDED|95.0|-1.17|-0.41|||Mixed Models Analysis|||Bedtime, Week 26||-0.41|-1.17|<0.001
72556422|NCT01648582|144644090|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.35||||0.067|TWO_SIDED|95.0|-0.73|-0.03|||Mixed Models Analysis|||Bedtime, Week 26||-0.03|-0.73|0.067
72556423|NCT01648582|144644090|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.77|||<|0.001|TWO_SIDED|95.0|0.52|1.01|||Mixed Models Analysis|||Morning pre-meal, Week 52||1.01|0.52|<0.001
72556424|NCT01648582|144644090|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|1.06|||<|0.001|TWO_SIDED|95.0|0.82|1.31|||Mixed Models Analysis|||Morning pre-meal, Week 52||1.31|0.82|<0.001
72556425|NCT01648582|144644090|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.53||||0.025|TWO_SIDED|95.0|-1.0|-0.07|||Mixed Models Analysis|||Morning 2-hours post-meal, Week 52||-0.07|-1.00|0.025
72380325|NCT02604017|144269269|NON_INFERIORITY|The noninferiority of the rate of SVR12 for the 8-week treatment group as compared with the 12-week treatment group was analyzed; the lower confidence bound of the 2-sided 95% confidence interval (95% CI) for the difference in percentage of participants with SVR12 (8-week group minus 12-week group) must be above -5% to achieve noninferiority.|Difference in Percentage of Participants|0.0|||||TWO_SIDED|95.0|-1.1|1.1||||||Based on a 2-sided significance level of 0.05 and an -5% noninferiority margin and an underlying rate of ≥97% in the 8-week arm (270 participants) and ≥97% in the 12-week arm (270 participants) provides \>90% power to demonstrate noninferiority of the 8-week arm to the 12-week arm.||1.1|-1.1|
72380326|NCT02604017|144269270|NON_INFERIORITY|The noninferiority of the rate of SVR12 for the 8-week treatment group as compared with the 12-week treatment group was analyzed; the lower confidence bound of the 2-sided 95% confidence interval (95% CI) for the difference in percentage of participants with SVR12 must be above -5% to achieve noninferiority.|Difference in Percentage of Participants|-0.6|||||TWO_SIDED|95.0|-1.8|0.6||||||Based on a 2-sided significance level of 0.05 and a -5% noninferiority margin, and an underlying rate of ≥97% in the 8-week arm (270 participants) and ≥97% in the 12-week arm (270 participants) provides \>90% power to demonstrate noninferiority of the 8-week arm to the 12-week arm.||0.6|-1.8|
72556426|NCT01648582|144644090|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.21||||0.384|TWO_SIDED|95.0|-0.67|0.26|||Mixed Models Analysis|||Morning 2-hours post-meal, Week 52||0.26|-0.67|0.384
72556427|NCT01648582|144644090|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.43||||0.024|TWO_SIDED|95.0|-0.8|-0.06|||Mixed Models Analysis|||Mid-day pre-meal, Week 52||-0.06|-0.80|0.024
72556428|NCT01648582|144644090|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.05||||0.783|TWO_SIDED|95.0|-0.32|0.42|||Mixed Models Analysis|||Mid-day pre-meal, Week 52||0.42|-0.32|0.783
72556429|NCT01648582|144644090|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.63||||0.004|TWO_SIDED|95.0|-1.07|-0.2|||Mixed Models Analysis|||Mid-day 2-hours post-meal, Week 52||-0.20|-1.07|0.004
72556430|NCT01648582|144644090|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.48||||0.029|TWO_SIDED|95.0|-0.92|-0.05|||Mixed Models Analysis|||Mid-day 2-hours post-meal, Week 52||-0.05|-0.92|0.029
72556431|NCT01648582|144644090|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.64|||<|0.001|TWO_SIDED|95.0|-1.01|-0.27|||Mixed Models Analysis|||Evening pre-meal, Week 52||-0.27|-1.01|<0.001
72380327|NCT00366340|144269292|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lowest limit of the 2-sided 95% CI for the difference between the 2 groups \> -10%.|Difference|0.0|||||TWO_SIDED|95.0|-2.5|2.6||||||For serotype 4 the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||2.6|-2.5|
72380328|NCT00366340|144269292|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lowest limit of the 2-sided 95% CI for the difference between the 2 groups \> -10%.|Difference|-9.6|||||TWO_SIDED|95.0|-16.0|-3.3||||||For serotype 6B the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||-3.3|-16.0|
72380329|NCT00366340|144269292|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lowest limit of the 2-sided 95% CI for the difference between the 2 groups \> -10%.|Difference|2.2|||||TWO_SIDED|95.0|-0.4|5.2||||||For serotype 9V the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||5.2|-0.4|
72380330|NCT00366340|144269292|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lowest limit of the 2-sided 95% CI for the difference between the 2 groups \> -10%.|Difference|1.5|||||TWO_SIDED|95.0|-0.9|4.1||||||For serotype 14 the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||4.1|-0.9|
72380331|NCT00366340|144269292|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lowest limit of the 2-sided 95% CI for the difference between the 2 groups \> -10%.|Difference|-1.4|||||TWO_SIDED|95.0|-4.2|1.2||||||For serotype 18C the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||1.2|-4.2|
72380332|NCT00366340|144269292|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lowest limit of the 2-sided 95% CI for the difference between the 2 groups \> -10%.|Difference|-0.3|||||TWO_SIDED|95.0|-3.8|3.3||||||For serotype 19F the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||3.3|-3.8|
72380333|NCT00366340|144269292|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lowest limit of the 2-sided 95% CI for the difference between the 2 groups \> -10%.|Difference|-0.8|||||TWO_SIDED|95.0|-6.0|4.5||||||For serotype 23F the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||4.5|-6.0|
72380334|NCT00366340|144269293|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the GMC ratio (13vPnC/7vPnC) \> 0.5 (2-fold criterion).|Ratio|0.73|||||TWO_SIDED|95.0|0.63|0.84||||||For serotype 4 the GMC ratio (13vPnC/7vPnC) was calculated||0.84|0.63|
72380335|NCT00366340|144269293|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the GMC ratio (13vPnC/7vPnC) \> 0.5 (2-fold criterion).|Ratio|0.65|||||TWO_SIDED|95.0|0.52|0.82||||||For serotype 6B the GMC ratio (13vPnC/7vPnC) was calculated||0.82|0.52|
72380336|NCT00366340|144269293|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the GMC ratio (13vPnC/7vPnC) \> 0.5 (2-fold criterion).|Ratio|0.84|||||TWO_SIDED|95.0|0.74|0.96||||||For serotype 9V the GMC ratio (13vPnC/7vPnC) was calculated||0.96|0.74|
72380337|NCT00366340|144269293|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the GMC ratio (13vPnC/7vPnC) \> 0.5 (2-fold criterion).|Ratio|0.9|||||TWO_SIDED|95.0|0.76|1.07||||||For serotype 14 the GMC ratio (13vPnC/7vPnC) was calculated||1.07|0.76|
72433627|NCT00991276|144380378|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-35.77|STANDARD_ERROR_OF_MEAN|7.63|<|0.0001|TWO_SIDED|95.0|-50.88|-20.66||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||-20.66|-50.88|<0.0001
72380338|NCT00366340|144269293|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the GMC ratio (13vPnC/7vPnC) \> 0.5 (2-fold criterion).|Ratio|2.25|||||TWO_SIDED|95.0|2.04|2.49||||||For serotype 18C the GMC ratio (13vPnC/7vPnC) was calculated||2.49|2.04|
72380339|NCT00366340|144269293|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the GMC ratio (13vPnC/7vPnC) \> 0.5 (2-fold criterion).|Ratio|0.6|||||TWO_SIDED|95.0|0.51|0.71||||||For serotype 19F the GMC ratio (13vPnC/7vPnC) was calculated||0.71|0.51|
72380340|NCT00366340|144269293|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the GMC ratio (13vPnC/7vPnC) \> 0.5 (2-fold criterion).|Ratio|0.88|||||TWO_SIDED|95.0|0.73|1.06||||||For serotype 23F the GMC ratio (13vPnC/7vPnC) was calculated||1.06|0.73|
72380341|NCT00366340|144269296|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|2.6|||||TWO_SIDED|95.0|-3.0|8.3||||||For Haemophilus influenzae type b the difference in percentage between the two groups (13vPnC - 7vPnC) at 0.15 µg/mL threshold was calculated||8.3|-3.0|
72556432|NCT01648582|144644090|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.1||||0.603|TWO_SIDED|95.0|-0.47|0.27|||Mixed Models Analysis|||Evening pre-meal, Week 52||0.27|-0.47|0.603
72380342|NCT00366340|144269296|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|4.5|||||TWO_SIDED|95.0|-4.1|13.0||||||For Haemophilus influenzae type b the difference in percentages between the two groups (13vPnC - 7vPnC) at 1.0 µg/mL threshold was calculated||13.0|-4.1|
72380343|NCT00366340|144269296|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|0.0||||||95.0|-1.4|1.5||||||For diphtheria toxoid the difference in percentages between the two groups(13vPnC - 7vPnC) at 0.01 IU/mL threshold was calculated||1.5|-1.4|
72380344|NCT00366340|144269296|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|-4.5||||||95.0|-9.3|0.3||||||For diphtheria toxoid the difference in percentages between the two groups (13vPnC - 7vPnC) at 0.1 IU/mL threshold was calculated||0.3|-9.3|
72380345|NCT00366340|144269296|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|0.0|||||TWO_SIDED|95.0|-1.5|1.5||||||For Haemophilus Influenzae Type b the difference in percentages between the two groups (13vPnC - 7vPnC) at 0.15 µg/mL threshold was calculated||1.5|-1.5|
72380346|NCT00366340|144269296|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|-1.3||||||95.0|-5.0|2.3||||||For hepatitis B the difference in percentages between the two groups (13vPnC - 7vPnC) at ≥ 10.0 mIU/mL threshold was calculated||2.3|-5.0|
72380347|NCT00366340|144269296|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|1.7|||||TWO_SIDED|95.0|-0.4|4.4||||||For Haemophilus influenzae type b the difference in percentages between the two groups (13vPnC - 7vPnC) at 1.0 µg/mL threshold was calculated||4.4|-0.4|
72380348|NCT00366340|144269296|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|0.0||||||95.0|-1.4|1.4||||||For diphtheria toxoid the difference in percentages between the two groups (13vPnC - 7vPnC) at 0.01 IU/mL threshold was calculated||1.4|-1.4|
72380349|NCT00366340|144269296|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|0.0||||||95.0|-1.4|1.4||||||For diphtheria toxoid the difference in percentages between the two groups (13vPnC - 7vPnC) at 0.1 IU/mL threshold was calculated||1.4|-1.4|
72380350|NCT00366340|144269296|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|0.8||||||95.0|-1.3|3.3||||||For hepatitis B the difference in percentages between the two groups (13vPnC - 7vPnC) at ≥ 10.0 mIU/mL threshold was calculated||3.3|-1.3|
72380351|NCT00366340|144269297|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for the concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|1.23|||||TWO_SIDED|95.0|0.96|1.58||||||For Haemophilus influenzae type b the GMC ratio (13vPnC/7vPnC) was calculated||1.58|0.96|
72380352|NCT00366340|144269297|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for the concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|1.15|||||TWO_SIDED|95.0|0.95|1.39||||||For Haemophilus influenzae type b µg/mL the GMC ratio (13vPnC/7vPnC) was calculated||1.39|0.95|
72380353|NCT00366340|144269298|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for the concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|0.68|||||TWO_SIDED|95.0|0.57|0.8||||||For diphtheria toxoid the GMC ratio (13vPnC/7vPnC) was calculated||0.80|0.57|
72380354|NCT00366340|144269298|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for the concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|0.87|||||TWO_SIDED|95.0|0.75|1.01||||||For diphtheria toxoid the GMC ratio (13vPnC/7vPnC) was calculated||1.01|0.75|
72380355|NCT00366340|144269299|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for the concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|0.88|||||TWO_SIDED|95.0|0.69|1.11||||||For hepatitis B the GMC ratio (13vPnC/7vPnC) was calculated.||1.11|0.69|
72433628|NCT00991276|144380378|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|46.47|STANDARD_ERROR_OF_MEAN|7.59|<|0.0001|TWO_SIDED|95.0|31.45|61.48||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||61.48|31.45|<0.0001
72380356|NCT00366340|144269299|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for the concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|0.93|||||TWO_SIDED|95.0|0.71|1.22||||||For hepatitis B the GMC ratio (13vPnC/7vPnC) was calculated||1.22|0.71|
72380357|NCT01315236|144269307|SUPERIORITY|||||||0.072||||||Conducted in the mITT population using a stratified Wilcoxon rank sum test, to compare the treatment arms at a 2-sided significance level of 0.05, adjusting for the randomization strata (presence/absence of CF and MAC versus Mycobacterium abscessus).|Wilcoxon rank sum test|||"The primary efficacy analysis tested the following hypotheses:~* H0: There is no difference at Day 84 between the LAI arm and the placebo arm~* Ha: There is a difference at Day 84 between the LAI arm and the placebo arm~Statistical analysis applies to all day 84 rows."||||0.072
72380358|NCT01315236|144269308|SUPERIORITY|||||||0.003|||||||Cochran-Mantel-Haenszel|||stratified Cochran-Mantel-Haenszel test||||0.003
72380359|NCT01315236|144269309|SUPERIORITY||Cox Proportional Hazard|5.68||||0.0129|TWO_SIDED|95.0|1.25|25.79|||Regression, Cox|||Cox proportional hazard model||25.79|1.25|0.0129
72380360|NCT01315236|144269310|SUPERIORITY|||||||0.077|||||||Regression, Logistic|||Ordinal Logistic Regressions Model||||0.077
72380361|NCT01315236|144269311|SUPERIORITY|||||||0.4545|||||||Wilcoxon (Mann-Whitney)|||Stratified Wilcoxon-rank sum||||0.4545
72380362|NCT01315236|144269313|SUPERIORITY||Cox Proportional Hazard|2.69||||0.0076|TWO_SIDED|95.0|1.28|5.64|||Regression, Cox|||Cox Proportional Hazard Model||5.64|1.28|0.0076
72380363|NCT02821910|144269325|SUPERIORITY_OR_OTHER_LEGACY||ratio (%)|96.7|STANDARD_DEVIATION|5.9|||TWO_SIDED|90.0|92.89|100.66|||||Relative bioavailability was estimated by the adjusted gMean ratio of T1 divided by R1. Standard deviation is actually intra-individual geometric coefficient variation (gCV).|The statistical model used was an Analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period', and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||100.66|92.89|
72556433|NCT01648582|144644090|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.83|||<|0.001|TWO_SIDED|95.0|-1.26|-0.41|||Mixed Models Analysis|||Evening 2-hours post-meal, Week 52||-0.41|-1.26|<0.001
72380364|NCT02821910|144269325|SUPERIORITY_OR_OTHER_LEGACY||ratio (%)|100.8|STANDARD_DEVIATION|4.8|||TWO_SIDED|90.0|97.99|103.7|||||Relative bioavailability was estimated by the adjusted gMean ratio of T2 divided by R2. Standard deviation is actually intra-individual geometric coefficient variation (gCV).|The statistical model used was an Analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period', and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||103.70|97.99|
72380365|NCT02821910|144269325|SUPERIORITY_OR_OTHER_LEGACY||ratio (%)|99.83|STANDARD_DEVIATION|5.9|||TWO_SIDED|90.0|95.96|103.85|||||Relative bioavailability was estimated by the adjusted gMean ratio of T3 divided by R3. Standard deviation is actually intra-individual geometric coefficient variation (gCV).|The statistical model used was an Analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period', and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||103.85|95.96|
72380366|NCT02821910|144269326|SUPERIORITY_OR_OTHER_LEGACY||ratio (%)|96.82|STANDARD_DEVIATION|9.7|||TWO_SIDED|90.0|90.65|103.42|||||Relative bioavailability was estimated by the adjusted gMean ratio of T1 divided by R1. Standard deviation is actually intra-individual geometric coefficient variation (gCV).|The statistical model used was an Analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period', and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||103.42|90.65|
72380367|NCT02821910|144269326|SUPERIORITY_OR_OTHER_LEGACY||ratio (%)|95.67|STANDARD_DEVIATION|15.5|||TWO_SIDED|90.0|87.44|104.68|||||Relative bioavailability was estimated by the adjusted gMean ratio of T2 divided by R2. Standard deviation is actually intra-individual geometric coefficient variation (gCV).|The statistical model used was an Analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period', and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||104.68|87.44|
72380368|NCT02821910|144269326|SUPERIORITY_OR_OTHER_LEGACY||ratio (%)|98.47|STANDARD_DEVIATION|9.9|||TWO_SIDED|90.0|92.12|105.25|||||Relative bioavailability was estimated by the adjusted gMean ratio of T3 divided by R3. Standard deviation is actually intra-individual geometric coefficient variation (gCV).|The statistical model used was an Analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period', and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||105.25|92.12|
72380369|NCT02821910|144269327|SUPERIORITY_OR_OTHER_LEGACY||ratio (%)|94.94|STANDARD_DEVIATION|13.8|||TWO_SIDED|90.0|86.6|104.08|||||Relative bioavailability was estimated by the adjusted gMean ratio of T1 divided by R1. Standard deviation is actually intra-individual geometric coefficient variation (gCV).|The statistical model used was an Analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period', and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||104.08|86.60|
72380370|NCT02821910|144269327|SUPERIORITY_OR_OTHER_LEGACY||ratio (%)|106.63|STANDARD_DEVIATION|9.9|||TWO_SIDED|90.0|100.65|112.96|||||Relative bioavailability was estimated by the adjusted gMean ratio of T2 divided by R2. Standard deviation is actually intra-individual geometric coefficient variation (gCV).|The statistical model used was an Analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period', and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||112.96|100.65|
72380371|NCT02821910|144269327|SUPERIORITY_OR_OTHER_LEGACY||ratio (%)|100.41|STANDARD_DEVIATION|8.9|||TWO_SIDED|90.0|94.54|106.64|||||Relative bioavailability was estimated by the adjusted gMean ratio of T3 divided by R3. Standard deviation is actually intra-individual geometric coefficient variation (gCV).|The statistical model used was an Analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period', and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||106.64|94.54|
72380372|NCT02821910|144269328|SUPERIORITY_OR_OTHER_LEGACY||ratio (%)|97.97|STANDARD_DEVIATION|10.2|||TWO_SIDED|90.0|91.46|104.94|||||Relative bioavailability was estimated by the adjusted gMean ratio of T1 divided by R1. Standard deviation is actually intra-individual geometric coefficient variation (gCV).|The statistical model used was an Analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period', and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||104.94|91.46|
72380373|NCT02821910|144269328|SUPERIORITY_OR_OTHER_LEGACY||ratio (%)|100.04|STANDARD_DEVIATION|17.9|||TWO_SIDED|90.0|90.23|110.91|||||Relative bioavailability was estimated by the adjusted gMean ratio of T2 divided by R2. Standard deviation is actually intra-individual geometric coefficient variation (gCV).|The statistical model used was an Analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period', and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||110.91|90.23|
72556434|NCT01648582|144644090|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.45||||0.039|TWO_SIDED|95.0|-0.87|-0.02|||Mixed Models Analysis|||Evening 2-hours post-meal, Week 52||-0.02|-0.87|0.039
72556435|NCT01648582|144644090|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.99|||<|0.001|TWO_SIDED|95.0|-1.39|-0.6|||Mixed Models Analysis|||Bedtime, Week 52||-0.60|-1.39|<0.001
72618564|NCT01026038|144768104|SUPERIORITY_OR_OTHER|||||||0.517||95.0|||||Fisher Exact|||Redness (Moderate): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.||||0.517
72618565|NCT01026038|144768104|SUPERIORITY_OR_OTHER|||||||0.323||95.0|||||Fisher Exact|||Redness (Severe): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/7vPnC/13vPnC.||||0.323
72380374|NCT02821910|144269328|SUPERIORITY_OR_OTHER_LEGACY||ratio (%)|101.24|STANDARD_DEVIATION|10.1|||TWO_SIDED|90.0|94.58|108.38|||||Relative bioavailability was estimated by the adjusted gMean ratio of T3 divided by R3. Standard deviation is actually intra-individual geometric coefficient variation (gCV).|The statistical model used was an Analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period', and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||108.38|94.58|
72380375|NCT02821910|144269329|SUPERIORITY_OR_OTHER_LEGACY||ratio (%)|97.5|STANDARD_DEVIATION|12.0|||TWO_SIDED|90.0|89.94|105.71|||||Relative bioavailability was estimated by the adjusted gMean ratio of T1 divided by R1. Standard deviation is actually intra-individual geometric coefficient variation (gCV).|The statistical model used was an Analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period', and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||105.71|89.94|
72380376|NCT02821910|144269329|SUPERIORITY_OR_OTHER_LEGACY||ratio (%)|117.31|STANDARD_DEVIATION|22.0|||TWO_SIDED|90.0|103.41|133.07|||||Relative bioavailability was estimated by the adjusted gMean ratio of T2 divided by R2. Standard deviation is actually intra-individual geometric coefficient variation (gCV).|The statistical model used was an Analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period', and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||133.07|103.41|
72380377|NCT02821910|144269329|SUPERIORITY_OR_OTHER_LEGACY||ratio (%)|102.74|STANDARD_DEVIATION|6.2|||TWO_SIDED|90.0|98.56|107.1|||||Relative bioavailability was estimated by the adjusted gMean ratio of T3 divided by R3. Standard deviation is actually intra-individual geometric coefficient variation (gCV).|The statistical model used was an Analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period', and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||107.10|98.56|
72380378|NCT02821910|144269330|SUPERIORITY_OR_OTHER_LEGACY||ratio (%)|96.34|STANDARD_DEVIATION|6.6|||TWO_SIDED|90.0|92.13|100.75|||||Relative bioavailability was estimated by the adjusted gMean ratio of T1 divided by R1. Standard deviation is actually intra-individual geometric coefficient variation (gCV).|The statistical model used was an Analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period', and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||100.75|92.13|
72380379|NCT02821910|144269330|SUPERIORITY_OR_OTHER_LEGACY||ratio (%)|105.07|STANDARD_DEVIATION|8.6|||TWO_SIDED|90.0|99.95|110.45|||||Relative bioavailability was estimated by the adjusted gMean ratio of T2 divided by R2. Standard deviation is actually intra-individual geometric coefficient variation (gCV).|The statistical model used was an Analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period', and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||110.45|99.95|
72380380|NCT02821910|144269330|SUPERIORITY_OR_OTHER_LEGACY||ratio (%)|100.31|STANDARD_DEVIATION|5.9|||TWO_SIDED|90.0|96.41|104.38|||||Relative bioavailability was estimated by the adjusted gMean ratio of T3 divided by R3. Standard deviation is actually intra-individual geometric coefficient variation (gCV).|The statistical model used was an Analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period', and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||104.38|96.41|
72380381|NCT02821910|144269331|SUPERIORITY_OR_OTHER_LEGACY||ratio (%)|96.63|STANDARD_DEVIATION|5.8|||TWO_SIDED|90.0|92.86|100.54|||||Relative bioavailability was estimated by the adjusted gMean ratio of T1 divided by R1. Standard deviation is actually intra-individual geometric coefficient variation (gCV).|The statistical model used was an Analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period', and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||100.54|92.86|
72380382|NCT02821910|144269331|SUPERIORITY_OR_OTHER_LEGACY||ratio (%)|100.87|STANDARD_DEVIATION|5.0|||TWO_SIDED|90.0|97.96|103.86|||||Relative bioavailability was estimated by the adjusted gMean ratio of T2 divided by R2. Standard deviation is actually intra-individual geometric coefficient variation (gCV).|The statistical model used was an Analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period', and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||103.86|97.96|
72493942|NCT03178487|144516785|SUPERIORITY|To preserve the overall type I error rate at α=0.05 level, a step-down approach was used to test the primary and multiplicity-controlled key secondary endpoints. The testing began with the primary endpoint at α=0.05 and continued conditional on significance of higher-ranked endpoint. The testing sequence included a group of endpoints tested by the Hochberg procedure, including WPAI; within the group, the allocated α was adjusted based on the magnitude of p values.|LS Mean Difference|-5.52||||0.19|TWO_SIDED|95.0|-13.82|2.78|||ANCOVA|ANCOVA model including treatment and Screening hsCRP level as fixed factors and Baseline value as covariate.|Treatment difference = Upadacitinib - Placebo|||2.78|-13.82|0.190
72556436|NCT01648582|144644090|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.59||||0.003|TWO_SIDED|95.0|-0.98|-0.2|||Mixed Models Analysis|||Bedtime, Week 52||-0.20|-0.98|0.003
72618566|NCT01026038|144768104|SUPERIORITY_OR_OTHER|||||||0.489||95.0|||||Fisher Exact|||Redness (Severe): Fisher exact test, 2-sided was used. Pairwise comparison was made between 7vPnC/7vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.||||0.489
72618567|NCT01026038|144768105|SUPERIORITY_OR_OTHER|||||||0.075|TWO_SIDED||||||Fisher Exact|||Fever (\>=38 degree C to \<=39 degree C): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/7vPnC/13vPnC||||0.075
72380383|NCT02821910|144269331|SUPERIORITY_OR_OTHER_LEGACY||ratio (%)|99.75|STANDARD_DEVIATION|6.0|||TWO_SIDED|90.0|95.81|103.86|||||Relative bioavailability was estimated by the adjusted gMean ratio of T3 divided by R3. Standard deviation is actually intra-individual geometric coefficient variation (gCV).|The statistical model used was an Analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period', and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||103.86|95.81|
72380384|NCT02821910|144269332|SUPERIORITY_OR_OTHER_LEGACY||ratio (%)|96.57|STANDARD_DEVIATION|8.9|||TWO_SIDED|90.0|90.94|102.56|||||Relative bioavailability was estimated by the adjusted gMean ratio of T1 divided by R1. Standard deviation is actually intra-individual geometric coefficient variation (gCV).|The statistical model used was an Analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period', and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||102.56|90.94|
72380385|NCT02821910|144269332|SUPERIORITY_OR_OTHER_LEGACY||ratio (%)|95.4|STANDARD_DEVIATION|14.9|||TWO_SIDED|90.0|87.5|104.01|||||Relative bioavailability was estimated by the adjusted gMean ratio of T2 divided by R2. Standard deviation is actually intra-individual geometric coefficient variation (gCV).|The statistical model used was an Analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period', and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||104.01|87.50|
72380386|NCT02821910|144269332|SUPERIORITY_OR_OTHER_LEGACY||ratio (%)|98.45|STANDARD_DEVIATION|9.4|||TWO_SIDED|90.0|92.44|104.85|||||Relative bioavailability was estimated by the adjusted gMean ratio of T3 divided by R3. Standard deviation is actually intra-individual geometric coefficient variation (gCV).|The statistical model used was an Analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period', and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||104.85|92.44|
72380387|NCT02821910|144269333|SUPERIORITY_OR_OTHER_LEGACY||ratio (%)|95.08|STANDARD_DEVIATION|12.6|||TWO_SIDED|90.0|87.36|103.48|||||Relative bioavailability was estimated by the adjusted gMean ratio of T1 divided by R1. Standard deviation is actually intra-individual geometric coefficient variation (gCV).|The statistical model used was an Analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period', and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||103.48|87.36|
72380388|NCT02821910|144269333|SUPERIORITY_OR_OTHER_LEGACY||ratio (%)|105.72|STANDARD_DEVIATION|11.7|||TWO_SIDED|90.0|98.78|113.15|||||Relative bioavailability was estimated by the adjusted gMean ratio of T2 divided by R2. Standard deviation is actually intra-individual geometric coefficient variation (gCV).|The statistical model used was an Analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period', and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||113.15|98.78|
72618568|NCT01026038|144768105|SUPERIORITY_OR_OTHER|||||||0.345||95.0|||||Fisher Exact|||Fever (\>=38 degree C to \<=39 degree C): Fisher exact test, 2-sided was used. Pairwise comparison was made between 7vPnC/7vPnC/13vPnC and 7vPnC/13vPnC/13vPnC||||0.345
72380389|NCT02821910|144269333|SUPERIORITY_OR_OTHER_LEGACY||ratio (%)|101.61|STANDARD_DEVIATION|14.9|||TWO_SIDED|90.0|92.0|112.22|||||Relative bioavailability was estimated by the adjusted gMean ratio of T3 divided by R3. Standard deviation is actually intra-individual geometric coefficient variation (gCV).|The statistical model used was an Analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period', and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||112.22|92.00|
72380390|NCT04218123|144269337|EQUIVALENCE|p value \<0.05 required to be considered nonequivalent|||||<|0.001|||||||ANOVA|||||||<0.001
72380391|NCT04218123|144269337|EQUIVALENCE|p value of \<0.05 required for result to be considered nonequivalent|||||<|0.05|||||||ANOVA|Anova Post Hoc Analysis||||||<0.05
72380392|NCT04218123|144269337|EQUIVALENCE|p value of \<0.05 required for result to be considered nonequivalent|||||<|0.05|||||||ANOVA|Anova Post Hoc Analysis||||||<0.05
72380393|NCT04218123|144269337|EQUIVALENCE|p value of \<0.05 required for result to be considered nonequivalent|||||>|0.05|||||||ANOVA|Anova Post Hoc Analysis||||||>0.05
72380394|NCT04218123|144269339|EQUIVALENCE|p value \<0.05 required to be considered nonequivalent|||||=|0.31|||||||ANOVA|||SF20 Physical Functioning||||=0.31
72380395|NCT04218123|144269339|EQUIVALENCE|p value of \<0.05 required for result to be considered nonequivalent||||||0.633|||||||ANOVA|||SF20 Role Functioning||||0.633
72380396|NCT04218123|144269339|EQUIVALENCE|p value of \<0.05 required for result to be considered nonequivalent||||||0.424|||||||ANOVA|||SF20 Mental Health||||0.424
72618569|NCT01026038|144768105|SUPERIORITY_OR_OTHER|||||||0.628||95.0|||||Fisher Exact|||Fever (\>=38 degree C to \<=39 degree C): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/13vPnC/13vPnC||||0.628
72380397|NCT04218123|144269339|EQUIVALENCE|p value of \<0.05 required for result to be considered nonequivalent||||||0.057|||||||ANOVA|||SF20 Social Functioning||||0.057
72380398|NCT04218123|144269339|EQUIVALENCE|p value of \<0.05 required for result to be considered nonequivalent||||||0.296|||||||ANOVA|||SF20 Health Perceptions||||0.296
72380399|NCT04218123|144269339|EQUIVALENCE|p value of \<0.05 required for result to be considered nonequivalent||||||0.872|||||||ANOVA|||SF20 Pain||||0.872
72380400|NCT04218123|144269340|EQUIVALENCE|p value \<0.05 required to be considered nonequivalent|||||=|0.538|||||||ANOVA|||||||=0.538
72380401|NCT04218123|144269341|EQUIVALENCE|p value \<0.05 required to be considered nonequivalent|||||=|0.686|||||||ANOVA|||||||=0.686
72556437|NCT01648582|144644091|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|34.41|STANDARD_ERROR_OF_MEAN|3.831||0.352|TWO_SIDED||||||Mixed Models Analysis|||HOMA2-%B, Dula 1.5 mg, Week 26||||0.352
72380402|NCT04218123|144269342|EQUIVALENCE|p value \<0.05 required to be considered nonequivalent|||||=|0.167|||||||ANOVA|||||||=0.167
72380403|NCT04218123|144269343|EQUIVALENCE|p value \<0.05 required to be considered nonequivalent|||||=|0.8|||||||ANOVA|||||||=0.8
72380404|NCT04218123|144269344|EQUIVALENCE|p value \<0.05 required to be considered nonequivalent|||||=|0.425|||||||ANOVA|||||||=0.425
72380405|NCT04218123|144269345|EQUIVALENCE|p value \<0.05 required to be considered nonequivalent.|||||=|0.054|||||||ANOVA|||||||=0.054
72380406|NCT01082640|144269346|SUPERIORITY_OR_OTHER||LS mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.134||0.459|TWO_SIDED|95.0|-0.37|0.17||No adjustment for multiplicity was made.|ANCOVA|The model included treatment as a factor, and the baseline value and prior use of an ARB or an ACEi or none as covariates.||All statistical tests were two sided and conducted at the 0.05 significance level.||0.17|-0.37|0.459
72380407|NCT01082640|144269346|SUPERIORITY_OR_OTHER||LS mean difference|0.04|STANDARD_ERROR_OF_MEAN|0.133||0.789|TWO_SIDED|95.0|-0.23|0.3||No adjustment for multiplicity was made.|ANCOVA|The model included treatment as a factor, and the baseline value and prior use of an ARB or an ACEi or none as covariates.||All statistical tests were two sided and conducted at the 0.05 significance level.||0.30|-0.23|0.789
72380408|NCT01082640|144269347|SUPERIORITY_OR_OTHER||LS mean difference|2.38|STANDARD_ERROR_OF_MEAN|1.687||0.162|TWO_SIDED|95.0|-0.97|5.73||No adjustment for multiplicity was made.|ANCOVA|The model included treatment as a factor, and the baseline value and prior use of an ARB or an ACEi or none as covariates.||||5.73|-0.97|0.162
72380409|NCT01082640|144269347|SUPERIORITY_OR_OTHER||LS mean difference|1.19|STANDARD_ERROR_OF_MEAN|1.698||0.485|TWO_SIDED|95.0|-2.18|4.57||No adjustment for multiplicity was made.|ANCOVA|The model included treatment as a factor, and the baseline value and prior use of an ARB or an ACEi or none as covariates.||||4.57|-2.18|0.485
72380410|NCT01082640|144269348|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|Prior use of an ARB, ACEi, or none was a stratification variable.||||||<0.001
72380411|NCT01082640|144269348|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|Prior use of an ARB, ACEi, or none was a stratification variable.||||||<0.001
72380412|NCT01082640|144269348|SUPERIORITY_OR_OTHER|||||||0.062|||||||Cochran-Mantel-Haenszel|Prior use of an ARB, ACEi, or none was a stratification variable.||||||0.062
72556438|NCT01648582|144644091|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|31.17|STANDARD_ERROR_OF_MEAN|3.761||0.352|TWO_SIDED||||||Mixed Models Analysis|||HOMA2-%B, Dula 0.75 mg, Week 26||||0.352
72380413|NCT02011893|144269382|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin is 7.5 points, where the Visual Analog Scale (VAS) scores were measured on a scale of 0 to 100. Testing was carried out at a 5% significance level.|||||<|0.001|||||||t-distribution|95% UCB and p-value for non-inferiority are based on t-distribution with n1 + n2-2 degrees of freedom where n1 and n2 are number of subjects per arm.||||||<0.001
72380414|NCT02011893|144269383|SUPERIORITY_OR_OTHER|||||||0.083||||||Superiority analysis performed|McNemar|||||||0.083
72380415|NCT02011893|144269385|SUPERIORITY_OR_OTHER|||||||0.017||||||Superiority analysis performed|t-distribution|95% UCB and p-value for superiority are based on t-distribution with n1 + n2-2 degrees of freedom where n1 and n2 are number of subjects per arm.||||||0.017
72380416|NCT01289782|144269386|SUPERIORITY_OR_OTHER||Difference in proportions of SVR12|29.3|||<|0.001|TWO_SIDED|95.0|20.1|38.6|||Cochran-Mantel-Haenszel|||Null hypothesis: There is no difference in proportions of SVR12 between the treatment groups.||38.6|20.1|<0.001
72380417|NCT01289782|144269387|SUPERIORITY_OR_OTHER||Difference in proportions of SVRW72|28.9|||<|0.001|TWO_SIDED|95.0|19.6|38.2|||Cochran-Mantel-Haenszel|||There is no difference in proportions of SVRW72 between the treatment groups.||38.2|19.6|<0.001
72380418|NCT01289782|144269388|SUPERIORITY_OR_OTHER||Difference in proportions of SVR24|30.1|||<|0.001|TWO_SIDED|95.0|20.8|39.3|||Cochran-Mantel-Haenszel|||There is no difference in proportions of SVR24 between the treatment groups.||39.3|20.8|<0.001
72380419|NCT01289782|144269389|SUPERIORITY_OR_OTHER||Difference in proportions of SVR4|25.8|||<|0.001|TWO_SIDED|95.0|16.8|34.8|||Cochran-Mantel-Haenszel|||There is no difference in proportions of SVR4 between the treatment groups.||34.8|16.8|<0.001
72433629|NCT00991276|144380379|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-7.73|STANDARD_ERROR_OF_MEAN|4.72||0.104|TWO_SIDED|95.0|-17.07|1.61||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||1.61|-17.07|0.1040
72380420|NCT01289782|144269416|SUPERIORITY_OR_OTHER||Mean differences|-20.679|STANDARD_ERROR_OF_MEAN|6.0979|<|0.001|TWO_SIDED|95.0|-32.6399|-8.7181|||Piecewise-Linear Model Approach|||Fatigue Severity Score AUC60||-8.7181|-32.6399|<0.001
72380421|NCT01289782|144269416|SUPERIORITY_OR_OTHER||Mean differences|-23.8|STANDARD_ERROR_OF_MEAN|7.2358|<|0.001|TWO_SIDED|95.0|-37.9931|-9.6064|||Piecewise Linear Model|||Fatigue Severity Score AUC72||-9.6064|-37.9931|<0.001
72380422|NCT01289782|144269417|SUPERIORITY_OR_OTHER||Mean differences|-230.464|STANDARD_ERROR_OF_MEAN|105.9203||0.03|TWO_SIDED|95.0|-438.2662|-22.6626|||Piecewise Linear Model|||Impairment in Work Productivity AUC60||-22.6626|-438.2662|0.030
72380423|NCT01289782|144269417|SUPERIORITY_OR_OTHER||Mean differences|-248.208|STANDARD_ERROR_OF_MEAN|124.6753||0.047|TWO_SIDED|95.0|-492.8253|-3.5916|||Piecewise Linear Model|||Impairment in Work Productivity AUC72||-3.5916|-492.8253|0.047
72380424|NCT01289782|144269418|SUPERIORITY_OR_OTHER||Mean Differences|-278.06|STANDARD_ERROR_OF_MEAN|105.6088||0.009|TWO_SIDED|95.0|-485.2529|-70.8668|||Piecewise linear model|||Impairment in Daily Activities AUC60||-70.8668|-485.2529|0.009
72380425|NCT01289782|144269418|SUPERIORITY_OR_OTHER||Mean differences|-307.722|STANDARD_ERROR_OF_MEAN|124.1956||0.013|TWO_SIDED|95.0|-551.4006|-64.0429|||Piecewise Linear Model|||Impairment in Daily Activities AUC72||-64.0429|-551.4006|0.013
72380426|NCT01289782|144269419|SUPERIORITY_OR_OTHER||Mean differences|46.399|STANDARD_ERROR_OF_MEAN|99.7966||0.642|TWO_SIDED|95.0|-149.6374|242.436|||Piecewise linear model|||Time Missed from Work AUC60||242.4360|-149.6374|0.642
72380427|NCT01289782|144269419|SUPERIORITY_OR_OTHER||Mean differences|57.164|STANDARD_ERROR_OF_MEAN|115.1548||0.62|TWO_SIDED|95.0|-169.1143|283.4414|||Piecewise Linear Model|||Time Missed from Work AUC72||283.4414|-169.1143|0.620
72556439|NCT01648582|144644091|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|45.12|STANDARD_ERROR_OF_MEAN|4.147||0.025|TWO_SIDED||||||Mixed Models Analysis|||HOMA2-%B, Dula 1.5, Week 52||||0.025
72556440|NCT01648582|144644091|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|36.64|STANDARD_ERROR_OF_MEAN|4.061||0.025|TWO_SIDED||||||Mixed Models Analysis|||HOMA2-%B, Dula 0.75 mg, Week 52||||0.025
72380428|NCT03239665|144269427|EQUIVALENCE|Two-sided Wilcoxon Rank-Sum test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)||||||0.0081||||||Two-sided Wilcoxon Rank-Sum test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)|Wilcoxon (Mann-Whitney)|||Testing total knowledge score change between groups from baseline to post intervention||||0.0081
72380429|NCT03239665|144269427|EQUIVALENCE|Two-sided Wilcoxon Rank-Sum test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)||||||0.0243||||||Two-sided Wilcoxon Rank-Sum test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)|Wilcoxon (Mann-Whitney)|||Testing zoster knowledge score change between groups from baseline to post intervention||||0.0243
72380430|NCT03239665|144269427|EQUIVALENCE|Two-sided Wilcoxon Rank-Sum test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)||||||0.071||||||Two-sided Wilcoxon Rank-Sum test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)|Wilcoxon (Mann-Whitney)|||Testing pneumonia knowledge score change between groups from baseline to post intervention||||0.0710
72380431|NCT03239665|144269427|EQUIVALENCE|Two-sided Wilcoxon Rank-Sum test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)||||||0.0008||||||Two-sided Wilcoxon Rank-Sum test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)|Wilcoxon (Mann-Whitney)|||Testing influenza knowledge score change between groups from baseline to post intervention||||0.0008
72380432|NCT03239665|144269427|EQUIVALENCE|Two-sided Wilcoxon Rank-Sum test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)||||||0.1094||||||Two-sided Wilcoxon Rank-Sum test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)|Wilcoxon (Mann-Whitney)|||Testing total knowledge score change between groups from baseline to one-month follow-up||||0.1094
72380433|NCT03239665|144269427|EQUIVALENCE|Two-sided Wilcoxon Rank-Sum test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)||||||0.2029||||||Two-sided Wilcoxon Rank-Sum test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)|Wilcoxon (Mann-Whitney)|||Testing zoster knowledge score change between groups from baseline to one-month follow-up||||0.2029
72380434|NCT03239665|144269427|EQUIVALENCE|Two-sided Wilcoxon Rank-Sum test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)||||||0.8599||||||Two-sided Wilcoxon Rank-Sum test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)|Wilcoxon (Mann-Whitney)|||Testing pneumonia knowledge score change between groups from baseline to one-month follow-up||||0.8599
72380435|NCT03239665|144269427|EQUIVALENCE|Two-sided Wilcoxon Rank-Sum test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)||||||0.0007||||||Two-sided Wilcoxon Rank-Sum test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)|Wilcoxon (Mann-Whitney)|||Testing influenza knowledge score change between groups from baseline to one-month follow-up||||0.0007
72380436|NCT03239665|144269427|EQUIVALENCE|Two-sided Wilcoxon Rank-Sum test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)||||||0.0246||||||Two-sided Wilcoxon Rank-Sum test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)|Wilcoxon (Mann-Whitney)|||Testing total knowledge score change between groups from post-intervention to one-month follow-up||||0.0246
72380437|NCT03239665|144269427|EQUIVALENCE|Two-sided Wilcoxon Rank-Sum test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)||||||0.078||||||Two-sided Wilcoxon Rank-Sum test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)|Wilcoxon (Mann-Whitney)|||Testing zoster knowledge score change between groups from post-intervention to one-month follow-up||||0.0780
72380438|NCT03239665|144269427|EQUIVALENCE|Two-sided Wilcoxon Rank-Sum test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)||||||0.0167||||||Two-sided Wilcoxon Rank-Sum test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)|Wilcoxon (Mann-Whitney)|||Testing pneumonia knowledge score change between groups from post-intervention to one-month follow-up||||0.0167
72380439|NCT03239665|144269427|EQUIVALENCE|Two-sided Wilcoxon Rank-Sum test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)||||||0.9417||||||Two-sided Wilcoxon Rank-Sum test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)|Wilcoxon (Mann-Whitney)|||Testing influenza knowledge score change between groups from post-intervention to one-month follow-up||||0.9417
72380440|NCT03239665|144269428|EQUIVALENCE|Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)||||||0.0011||||||Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)|Sign test|||"Testing within-group changes in beliefs for the statement Getting vaccinations is important to my health from baseline to post-intervention"||||0.0011
72380441|NCT03239665|144269428|EQUIVALENCE|Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)|||||<|0.0001||||||Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)|Sign test|||"Testing within-group changes in beliefs for the statement Getting vaccinations is important to my health from baseline to post-intervention"||||<0.0001
72380442|NCT03239665|144269428|EQUIVALENCE|Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)||||||0.0028||||||Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)|Sign test|||"Testing within-group changes in beliefs for the statement Getting vaccinations is important to my health from baseline to one-month follow-up"||||0.0028
72380443|NCT03239665|144269428|EQUIVALENCE|Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)|||||<|0.0001||||||Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)|Sign test|||"Testing within-group changes in beliefs for the statement Getting vaccinations is important to my health from baseline to one-month follow-up"||||<0.0001
72556441|NCT01648582|144644092|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|36.57|STANDARD_ERROR_OF_MEAN|2.977||0.025|TWO_SIDED||||||Mixed Models Analysis|||HOMA2-%S, Dula 1.5 mg, Week 26||||0.025
72556442|NCT01648582|144644092|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|30.42|STANDARD_ERROR_OF_MEAN|2.94||0.025|TWO_SIDED||||||Mixed Models Analysis|||HOMA2-%S, Dula 0.75 mg, Week 26||||0.025
72556443|NCT01648582|144644092|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|41.02|STANDARD_ERROR_OF_MEAN|2.9||0.029|TWO_SIDED||||||Mixed Models Analysis|||HOMA2-%S, Dula 1.5 mg, Week 52||||0.029
72380444|NCT03239665|144269428|EQUIVALENCE|Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)||||||1||||||Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)|Sign test|||"Testing within-group changes in beliefs for the statement Getting vaccinations is important to my health from post-intervention to one-month follow-up"||||1.0
72380445|NCT03239665|144269428|EQUIVALENCE|Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)||||||0.643||||||Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)|Sign test|||"Testing within-group changes in beliefs for the statement Getting vaccinations is important to my health from post-intervention to one-month follow-up"||||0.6430
72380446|NCT03239665|144269428|EQUIVALENCE|Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)||||||0.1193||||||Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)|Sign test|||"Testing within-group changes in beliefs for the statement Getting vaccinations can be harmful to my health from baseline to post-intervention"||||0.1193
72380447|NCT03239665|144269428|EQUIVALENCE|Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)|||||<|0.0001||||||Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)|Sign test|||"Testing within-group changes in beliefs for the statement Getting vaccinations can be harmful to my health from baseline to post-intervention"||||<0.0001
72380448|NCT03239665|144269428|EQUIVALENCE|Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)||||||0.4861||||||Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)|Sign test|||"Testing within-group changes in beliefs for the statement Getting vaccinations can be harmful to my health from baseline to one-month follow-up"||||0.4861
72380449|NCT03239665|144269428|EQUIVALENCE|Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)||||||0.0002||||||Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)|Sign test|||"Testing within-group changes in beliefs for the statement Getting vaccinations can be harmful to my health from baseline to one-month follow-up"||||0.0002
72380450|NCT03239665|144269428|EQUIVALENCE|Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)||||||0.3247||||||Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)|Sign test|||"Testing within-group changes in beliefs for the statement Getting vaccinations can be harmful to my health from post-intervention to one-month follow-up"||||0.3247
72380451|NCT03239665|144269428|EQUIVALENCE|Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)||||||0.4627||||||Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)|Sign test|||"Testing within-group changes in beliefs for the statement Getting vaccinations can be harmful to my health from post-intervention to one-month follow-up"||||0.4627
72380452|NCT03239665|144269428|EQUIVALENCE|Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)||||||0.1244||||||Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)|Sign test|||"Testing within-group changes in beliefs for the statement I trust my doctor to give me information about vaccines and the diseases they prevent from baseline to post-intervention"||||0.1244
72380453|NCT03239665|144269428|EQUIVALENCE|Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)||||||0.0575||||||Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)|Sign test|||"Testing within-group changes in beliefs for the statement I trust my doctor to give me information about vaccines and the diseases they prevent from baseline to post-intervention"||||0.0575
72493943|NCT03178487|144516786|OTHER|"To preserve the overall type I error rate at α=0.05 level, a step-down approach was used to test the primary and multiplicity-controlled key secondary endpoints. The testing began with the primary endpoint at α=0.05 and continued conditional on significance of higher-ranked endpoint.~ASAS HI was to be evaluated only if the group of endpoints tested by Hochberg procedure were all significant."|LS Mean Difference|-1.37||||0.007|TWO_SIDED|95.0|-2.37|-0.37||This comparison was not tested for statistical significance because the hierarchical testing procedures stopped during the Hochberg procedure.|Mixed Effect Model Repeated Measurement|MMRM model includes treatment, visit, treatment-by-visit interaction as fixed effects and Screening hsCRP level and Baseline value as covariates.|Treatment difference = Upadacitinib - Placebo|||-0.37|-2.37|0.007
72556444|NCT01648582|144644092|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|35.19|STANDARD_ERROR_OF_MEAN|2.864||0.029|TWO_SIDED||||||Mixed Models Analysis|||HOMA2-%S, Dula 0.75 mg, Week 52||||0.029
72380454|NCT03239665|144269428|EQUIVALENCE|Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)||||||0.7489||||||Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)|Sign test|||"Testing within-group changes in beliefs for the statement I trust my doctor to give me information about vaccines and the diseases they prevent from baseline to one-month follow-up"||||0.7489
72380455|NCT03239665|144269428|EQUIVALENCE|Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)||||||0.0098||||||Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)|Sign test|||"Testing within-group changes in beliefs for the statement I trust my doctor to give me information about vaccines and the diseases they prevent from baseline to one-month follow-up"||||0.0098
72380456|NCT03239665|144269428|EQUIVALENCE|Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)||||||0.1797||||||Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)|Sign test|||"Testing within-group changes in beliefs for the statement I trust my doctor to give me information about vaccines and the diseases they prevent from post-intervention to one-month follow-up"||||0.1797
72493944|NCT03178487|144516787|OTHER||Response Rate Difference|24.1||||0.001|TWO_SIDED|95.0|10.2|38.0||This comparison was not part of the pre-specified multiplicity testing sequence.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusting for stratification factor of Screening hsCRP level.|||Response Rate Difference = Upadacitinib - Placebo|38.0|10.2|0.001
72556445|NCT01648582|144644095|SUPERIORITY_OR_OTHER_LEGACY|||||||0.008||||||Overall p-value|Mixed Models Analysis|||Week 26 SBP||||0.008
72380457|NCT03239665|144269428|EQUIVALENCE|Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)||||||0.3613||||||Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)|Sign test|||"Testing within-group changes in beliefs for the statement I trust my doctor to give me information about vaccines and the diseases they prevent from post-intervention to one-month follow-up"||||0.3613
72380458|NCT03239665|144269428|EQUIVALENCE|Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)||||||0.5972||||||Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)|Sign test|||"Testing within-group changes in beliefs for the statement I trust my pharmacist to give me information about vaccines and the diseases they prevent from baseline to post-intervention"||||0.5972
72380459|NCT03239665|144269428|EQUIVALENCE|Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)||||||0.024||||||Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)|Sign test|||"Testing within-group changes in beliefs for the statement I trust my pharmacist to give me information about vaccines and the diseases they prevent from baseline to post-intervention"||||0.0240
72380460|NCT03239665|144269428|EQUIVALENCE|Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)||||||0.2437||||||Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)|Sign test|||"Testing within-group changes in beliefs for the statement I trust my pharmacist to give me information about vaccines and the diseases they prevent from baseline to one-month follow-up"||||0.2437
72380461|NCT03239665|144269428|EQUIVALENCE|Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)||||||0.0631||||||Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)|Sign test|||"Testing within-group changes in beliefs for the statement I trust my pharmacist to give me information about vaccines and the diseases they prevent from baseline to one-month follow-up"||||0.0631
72380462|NCT03239665|144269428|EQUIVALENCE|Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)||||||0.054||||||Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)|Sign test|||"Testing within-group changes in beliefs for the statement I trust my pharmacist to give me information about vaccines and the diseases they prevent from post-intervention to one-month follow-up"||||0.0540
72380463|NCT03239665|144269428|EQUIVALENCE|Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)||||||0.7298||||||Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)|Sign test|||"Testing within-group changes in beliefs for the statement I trust my pharmacist to give me information about vaccines and the diseases they prevent from post-intervention to one-month follow-up"||||0.7298
72380464|NCT03239665|144269428|EQUIVALENCE|Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)||||||0.4218||||||Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)|Sign test|||"Testing within-group changes in beliefs for the statement I trust a peer educator to give me information about vaccines and the diseases they prevent from baseline to post-intervention"||||0.4218
72380465|NCT03239665|144269428|EQUIVALENCE|Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)||||||0.2282||||||Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)|Sign test|||"Testing within-group changes in beliefs for the statement I trust a peer educator to give me information about vaccines and the diseases they prevent from baseline to post-intervention"||||0.2282
72380466|NCT03239665|144269428|EQUIVALENCE|Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)||||||0.8711||||||Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)|Sign test|||"Testing within-group changes in beliefs for the statement I trust a peer educator to give me information about vaccines and the diseases they prevent from baseline to one-month follow-up"||||0.8711
72380467|NCT03239665|144269428|EQUIVALENCE|Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)||||||0.0027||||||Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)|Sign test|||"Testing within-group changes in beliefs for the statement I trust a peer educator to give me information about vaccines and the diseases they prevent from baseline to one-month follow-up"||||0.0027
72556446|NCT01648582|144644095|SUPERIORITY_OR_OTHER_LEGACY|||||||0.584||||||Overall p-value|Mixed Models Analysis|||Week 26 DBP||||0.584
72556447|NCT01648582|144644095|SUPERIORITY_OR_OTHER_LEGACY|||||||0.169||||||Overall p-value|Mixed Models Analysis|||Week 52 SBP||||0.169
72380468|NCT03239665|144269428|EQUIVALENCE|Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)||||||0.7579||||||Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)|Sign test|||"Testing within-group changes in beliefs for the statement I trust a peer educator to give me information about vaccines and the diseases they prevent from post-intervention to one-month follow-up"||||0.7579
72380469|NCT03239665|144269428|EQUIVALENCE|Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)||||||0.1299||||||Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)|Sign test|||"Testing within-group changes in beliefs for the statement I trust a peer educator to give me information about vaccines and the diseases they prevent from post-intervention to one-month follow-up"||||0.1299
72380470|NCT03239665|144269430|EQUIVALENCE|Fisher's Exact test was used (2 x 2) with a significance threshold of 0.05.||||||1||||||Fisher's Exact test was used (2 x 2) with a significance threshold of 0.05.|Fisher Exact|||Testing between-group differences in dichotomous engagement in the program immediately post-intervention via Fisher's Exact test||||1.0
72556448|NCT01648582|144644095|SUPERIORITY_OR_OTHER_LEGACY|||||||0.11||||||Overall p-value|Mixed Models Analysis|||Week 52 DBP||||0.110
72556449|NCT01648582|144644096|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||Overall p-value|Mixed Models Analysis|||Week 26||||<0.001
72556450|NCT01648582|144644096|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||Overall p-value|Mixed Models Analysis|||Week 52||||<0.001
72556451|NCT01648582|144644103|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||Week 26|Mixed Models Analysis|||||||<0.001
72380471|NCT03239665|144269430|EQUIVALENCE|Fisher's Exact test was used (2 x 2) with a significance threshold of 0.05.||||||0.6806||||||Fisher's Exact test was used (2 x 2) with a significance threshold of 0.05.|Fisher Exact|||Testing between-group differences in dichotomous engagement in the program at the one-month follow-up via Fisher's Exact test||||0.6806
72380472|NCT03239665|144269430|EQUIVALENCE|Fisher's Exact test was used (2 x 2) with a significance threshold of 0.05.||||||1||||||Fisher's Exact test was used (2 x 2) with a significance threshold of 0.05.|Fisher Exact|||Testing between-group differences in dichotomous satisfaction with the program's content immediately post-intervention via Fisher's Exact test||||1.0
72380473|NCT03239665|144269430|EQUIVALENCE|Fisher's Exact test was used (2 x 2) with a significance threshold of 0.05.||||||0.4908||||||Fisher's Exact test was used (2 x 2) with a significance threshold of 0.05.|Fisher Exact|||Testing between-group differences in dichotomous satisfaction with the program's content at the one-month follow-up via Fisher's Exact test||||0.4908
72380474|NCT03239665|144269431|EQUIVALENCE|Chi-squared test was used with a significance threshold of 0.05.||||||0.7728|||||||Chi-squared|||Testing between-group differences in number of participants planning to receive zoster vaccine at baseline via Chi-squared test||||0.7728
72380475|NCT03239665|144269431|EQUIVALENCE|Chi-squared test was used with a significance threshold of 0.05.||||||0.6871|||||||Chi-squared|||Testing between-group differences in number of participants planning to receive zoster vaccine post-intervention via Chi-squared test||||0.6871
72380476|NCT03239665|144269431|EQUIVALENCE|Chi-squared test was used with a significance threshold of 0.05.||||||0.8259|||||||Chi-squared|||Testing between-group differences in number of participants planning to receive zoster vaccine at one-month follow-up via Chi-squared test||||0.8259
72380477|NCT03239665|144269431|EQUIVALENCE|Chi-squared test was used with a significance threshold of 0.05.||||||0.8868|||||||Chi-squared|||Testing between-group differences in number of participants planning to receive influenza vaccine at baseline via Chi-squared test||||0.8868
72380478|NCT03239665|144269431|EQUIVALENCE|Chi-squared test was used with a significance threshold of 0.05.||||||0.8069|||||||Chi-squared|||Testing between-group differences in number of participants planning to receive influenza vaccine post-intervention via Chi-squared test||||0.8069
72380479|NCT03239665|144269431|EQUIVALENCE|Chi-squared test was used with a significance threshold of 0.05.||||||0.8489|||||||Chi-squared|||Testing between-group differences in number of participants planning to receive influenza vaccine at one-month follow-up via Chi-squared test||||0.8489
72380480|NCT03239665|144269431|EQUIVALENCE|Chi-squared test was used with a significance threshold of 0.05.||||||0.3985|||||||Chi-squared|||Testing between-group differences in number of participants planning to receive pneumonia vaccine at baseline via Chi-squared test||||0.3985
72433630|NCT00991276|144380379|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|4.68||0.9325|TWO_SIDED|95.0|-9.67|8.87||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||8.87|-9.67|0.9325
72556452|NCT01648582|144644103|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||Week 52||||<0.001
72380481|NCT03239665|144269431|EQUIVALENCE|Chi-squared test was used with a significance threshold of 0.05.||||||0.1722|||||||Chi-squared|||Testing between-group differences in number of participants planning to receive pneumonia vaccine post-intervention via Chi-squared test||||0.1722
72380482|NCT03239665|144269431|EQUIVALENCE|Chi-squared test was used with a significance threshold of 0.05.||||||0.7318|||||||Chi-squared|||Testing between-group differences in number of participants planning to receive pneumonia vaccine at one-month follow-up via Chi-squared test||||0.7318
72556453|NCT01648582|144644104|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||Week 26||||<0.001
72618570|NCT01026038|144768105|SUPERIORITY_OR_OTHER|||||||0.592||95.0|||||Fisher Exact|||Fever (\>=39 degree C to \<=40 degree C): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/7vPnC/13vPnC.||||0.592
72380483|NCT03239665|144269431|EQUIVALENCE|Chi-squared test was used with a significance threshold of 0.05.||||||0.6309|||||||Chi-squared|||Among those without positive vaccination history at post-test, testing between-group differences in number of participants planning to receive zoster vaccine post-intervention via Chi-squared test||||0.6309
72380484|NCT03239665|144269431|EQUIVALENCE|Chi-squared test was used with a significance threshold of 0.05.||||||0.7881|||||||Chi-squared|||Among those without positive vaccination history at post-test, testing between-group differences in number of participants planning to receive zoster vaccine at one-month follow-up via Chi-squared test||||0.7881
72380485|NCT03239665|144269431|EQUIVALENCE|Chi-squared test was used with a significance threshold of 0.05.||||||0.6798|||||||Chi-squared|||Among those without positive vaccination history at post-test, testing between-group differences in number of participants planning to receive influenza vaccine post-intervention via Chi-squared test||||0.6798
72380486|NCT03239665|144269431|EQUIVALENCE|Chi-squared test was used with a significance threshold of 0.05.||||||0.8548|||||||Chi-squared|||Among those without positive vaccination history at post-test, testing between-group differences in number of participants planning to receive influenza vaccine at one-month follow-up via Chi-squared test||||0.8548
72380487|NCT03239665|144269431|EQUIVALENCE|Chi-squared test was used with a significance threshold of 0.05.||||||0.3182|||||||Chi-squared|||Among those without positive vaccination history at post-test, testing between-group differences in number of participants planning to receive pneumonia vaccine post-intervention via Chi-squared test||||0.3182
72380488|NCT03239665|144269431|EQUIVALENCE|Chi-squared test was used with a significance threshold of 0.05.||||||0.7986|||||||Chi-squared|||Among those without positive vaccination history at post-test, testing between-group differences in number of participants planning to receive pneumonia vaccine at one-month follow-up via Chi-squared test||||0.7986
72556454|NCT01648582|144644104|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||Week 52||||<0.001
72556455|NCT00840216|144644160|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using PROC GLM procedures in SAS, analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Test/Ref Ratio of LS Means x 100|106.9||||||90.0|||||||Bioequivalence is established when the ratio of the mean falls within 80-125.|||||
72380489|NCT03239665|144269432|EQUIVALENCE|Chi-squared test was used with a significance threshold of 0.05.||||||0.0163|||||||Chi-squared|||Testing between-group differences in number of participants reporting positive history of zoster vaccine at baseline via Chi-squared test||||0.0163
72380490|NCT03239665|144269432|EQUIVALENCE|Chi-squared test was used with a significance threshold of 0.05.||||||0.0028|||||||Chi-squared|||Testing between-group differences in number of participants reporting positive history of zoster vaccine post-intervention via Chi-squared test||||0.0028
72380491|NCT03239665|144269432|EQUIVALENCE|Chi-squared test was used with a significance threshold of 0.05.||||||0.0433|||||||Chi-squared|||Testing between-group differences in number of participants reporting positive history of zoster vaccine at one-month follow-up via Chi-squared test||||0.0433
72380492|NCT03239665|144269432|EQUIVALENCE|Chi-squared test was used with a significance threshold of 0.05.||||||0.0592|||||||Chi-squared|||Testing between-group differences in number of participants reporting positive history of influenza vaccine at baseline via Chi-squared test||||0.0592
72380493|NCT03239665|144269432|EQUIVALENCE|Chi-squared test was used with a significance threshold of 0.05.||||||0.1843|||||||Chi-squared|||Testing between-group differences in number of participants reporting positive history of influenza vaccine post-intervention via Chi-squared test||||0.1843
72380494|NCT03239665|144269432|EQUIVALENCE|Chi-squared test was used with a significance threshold of 0.05.||||||0.5933|||||||Chi-squared|||Testing between-group differences in number of participants reporting positive history of influenza vaccine at one-month follow-up via Chi-squared test||||0.5933
72380495|NCT03239665|144269432|EQUIVALENCE|Chi-squared test was used with a significance threshold of 0.05.||||||0.3942|||||||Chi-squared|||Testing between-group differences in number of participants reporting positive history of pneumonia vaccine at baseline via Chi-squared test||||0.3942
72380496|NCT03239665|144269432|EQUIVALENCE|Chi-squared test was used with a significance threshold of 0.05.||||||0.9062|||||||Chi-squared|||Testing between-group differences in number of participants reporting positive history of pneumonia vaccine post-intervention via Chi-squared test||||0.9062
72380497|NCT03239665|144269432|EQUIVALENCE|Chi-squared test was used with a significance threshold of 0.05.||||||0.9618|||||||Chi-squared|||Testing between-group differences in number of participants reporting positive history of pneumonia vaccine at one-month follow-up via Chi-squared test||||0.9618
72556456|NCT00840216|144644161|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using PROC GLM procedures in SAS, analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Test/Ref Ratio of LS Means x 100|92.7||||||90.0|||||||Bioequivalence is established when ratio of the mean falls within 80-125.|||||
72380498|NCT03239665|144269432|EQUIVALENCE|Chi-squared test was used with a significance threshold of 0.05.||||||0.114|||||||Chi-squared|||Among those without positive vaccination history at post-test, testing between-group differences in number of participants reporting positive history of zoster vaccine at one-month follow-up via Chi-squared test||||0.1140
72380499|NCT03239665|144269432|EQUIVALENCE|Chi-squared test was used with a significance threshold of 0.05.||||||0.0141|||||||Chi-squared|||Among those without positive vaccination history at post-test, testing between-group differences in number of participants reporting positive history of influenza vaccine at one-month follow-up via Chi-squared test||||0.0141
72380500|NCT03239665|144269432|EQUIVALENCE|Chi-squared test was used with a significance threshold of 0.05.||||||0.0457|||||||Chi-squared|||Among those without positive vaccination history at post-test, testing between-group differences in number of participants reporting positive history of pneumonia vaccine at one-month follow-up via Chi-squared test||||0.0457
72380501|NCT03239665|144269433|EQUIVALENCE|Chi-squared test was used with a significance threshold of 0.05.||||||0.6153|||||||Chi-squared|||Testing between-group differences in number of participants planning to discuss vaccines with their doctor at baseline via Chi-squared test||||0.6153
72380502|NCT03239665|144269433|EQUIVALENCE|Chi-squared test was used with a significance threshold of 0.05.||||||0.8299|||||||Chi-squared|||Testing between-group differences in number of participants planning to discuss vaccines with their doctor post-intervention via Chi-squared test||||0.8299
72380503|NCT03239665|144269433|EQUIVALENCE|Chi-squared test was used with a significance threshold of 0.05.||||||0.0405|||||||Chi-squared|||Testing between-group differences in number of participants planning to discuss vaccines with their doctor at one-month follow-up via Chi-squared test||||0.0405
72380504|NCT03239665|144269433|EQUIVALENCE|Chi-squared test was used with a significance threshold of 0.05.||||||0.3776|||||||Chi-squared|||Testing between-group differences in number of participants planning to discuss vaccines with their pharmacist at baseline via Chi-squared test||||0.3776
72380505|NCT03239665|144269433|EQUIVALENCE|Chi-squared test was used with a significance threshold of 0.05.||||||0.2856|||||||Chi-squared|||Testing between-group differences in number of participants planning to discuss vaccines with their pharmacist post-intervention via Chi-squared test||||0.2856
72380506|NCT03239665|144269433|EQUIVALENCE|Chi-squared test was used with a significance threshold of 0.05.||||||0.0016|||||||Chi-squared|||Testing between-group differences in number of participants planning to discuss vaccines with their pharmacist at one-month follow-up via Chi-squared test||||0.0016
72380507|NCT03239665|144269433|EQUIVALENCE|Chi-squared test was used with a significance threshold of 0.05.||||||0.9449|||||||Chi-squared|||Testing between-group differences in number of participants planning to discuss vaccines with their family/friends at baseline via Chi-squared test||||0.9449
72380508|NCT03239665|144269433|EQUIVALENCE|Chi-squared test was used with a significance threshold of 0.05.||||||0.6143|||||||Chi-squared|||Testing between-group differences in number of participants planning to discuss vaccines with their family/friends post-intervention via Chi-squared test||||0.6143
72380509|NCT03239665|144269433|EQUIVALENCE|Chi-squared test was used with a significance threshold of 0.05.||||||0.0036|||||||Chi-squared|||Testing between-group differences in number of participants planning to discuss vaccines with their family/friends at one-month follow-up via Chi-squared test||||0.0036
72380510|NCT03239665|144269434|EQUIVALENCE|Chi-squared test was used with a significance threshold of 0.05.|||||<|0.0001|||||||Chi-squared|||Testing between-group differences in number of participants having discussed vaccines with their doctor at one-month follow-up via Chi-squared test||||<0.0001
72380511|NCT03239665|144269434|EQUIVALENCE|Chi-squared test was used with a significance threshold of 0.05.||||||0.0012|||||||Chi-squared|||Testing between-group differences in number of participants having discussed vaccines with their pharmacist at one-month follow-up via Chi-squared test||||0.0012
72380512|NCT03239665|144269434|EQUIVALENCE|Chi-squared test was used with a significance threshold of 0.05.||||||0.0034|||||||Chi-squared|||Testing between-group differences in number of participants having discussed vaccines with their family/friends at one-month follow-up via Chi-squared test||||0.0034
72380513|NCT01582854|144269449|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.3|STANDARD_ERROR_OF_MEAN|0.82||0.005|TWO_SIDED|95.0|-3.9|-0.7|||ANCOVA|||||-0.7|-3.9|0.005
72380514|NCT01582854|144269450|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|0.74||0.122|TWO_SIDED|95.0|-2.6|0.3|||ANCOVA|||Month 3||0.3|-2.6|0.122
72380515|NCT01582854|144269450|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.7|STANDARD_ERROR_OF_MEAN|0.93|<|0.001|TWO_SIDED|95.0|-5.5|-1.9|||ANCOVA|||Month 12||-1.9|-5.5|<0.001
72380516|NCT01582854|144269451|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|0.2||0.111|TWO_SIDED|95.0|-0.1|0.7|||ANCOVA|||End of Infusion Period||0.7|-0.1|0.111
72380517|NCT01582854|144269451|SUPERIORITY_OR_OTHER||LS Mean Difference|0.7|STANDARD_ERROR_OF_MEAN|0.27||0.016|TWO_SIDED|95.0|0.1|1.2|||ANCOVA|||Month 3||1.2|0.1|0.016
72380518|NCT01582854|144269451|SUPERIORITY_OR_OTHER||LS Mean Difference|0.7|STANDARD_ERROR_OF_MEAN|0.29||0.013|TWO_SIDED|95.0|0.2|1.3|||ANCOVA|||Month 6||1.3|0.2|0.013
72380519|NCT01582854|144269451|SUPERIORITY_OR_OTHER||LS Mean Difference|1.0|STANDARD_ERROR_OF_MEAN|0.34||0.003|TWO_SIDED|95.0|0.3|1.7|||ANCOVA|||Month 12||1.7|0.3|0.003
72380520|NCT01582854|144269452|SUPERIORITY_OR_OTHER||Percent Difference|10.2||||0.032|TWO_SIDED|95.0|0.9|19.5|||Chi-squared|||Month 3||19.5|0.9|0.032
72380521|NCT01582854|144269452|SUPERIORITY_OR_OTHER||Percent Difference|10.2||||0.034|TWO_SIDED|95.0|0.8|19.5|||Chi-squared|||Month 6||19.5|0.8|0.034
72556457|NCT00840216|144644162|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using PROC GLM procedures in SAS, analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Test/Ref Ratio of LS Means x 100|93.0||||||90.0|||||||Bioequivalence is established when ratio of the mean falls within 80-125.|||||
72380522|NCT01582854|144269452|SUPERIORITY_OR_OTHER||Percent Difference|10.1||||0.035|TWO_SIDED|95.0|0.8|19.3|||Chi-squared|||Month 12||19.3|0.8|0.035
72380523|NCT01582854|144269453|SUPERIORITY_OR_OTHER||Percent Difference|-3.2||||0.251|TWO_SIDED|95.0|-8.5|2.1|||Fisher Exact|||Month 6||2.1|-8.5|0.251
72380524|NCT01582854|144269453|SUPERIORITY_OR_OTHER||Percent Difference|-4.0||||0.221|TWO_SIDED|95.0|-9.7|1.7|||Fisher Exact|||Month 12||1.7|-9.7|0.221
72380525|NCT01582854|144269454|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.14||0.239|TWO_SIDED|95.0|-0.4|0.1|||ANCOVA|||End of Infusion Period||0.1|-0.4|0.239
72380526|NCT01582854|144269454|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.14||0.136|TWO_SIDED|95.0|-0.5|0.1|||ANCOVA|||Month 3||0.1|-0.5|0.136
72380527|NCT01582854|144269454|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.14||0.89|TWO_SIDED|95.0|-0.3|0.2|||ANCOVA|||Month 6||0.2|-0.3|0.890
72380528|NCT01582854|144269454|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.14||0.455|TWO_SIDED|95.0|-0.4|0.2|||ANCOVA|||Month 12||0.2|-0.4|0.455
72380529|NCT06138145|144269461|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
72380530|NCT06138145|144269461|OTHER||||||<|0.05|TWO_SIDED|95.0|||||Mann-Whitney U test|||||||<0.05
72380531|NCT06138145|144269461|SUPERIORITY||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
72380532|NCT02652767|144269462|SUPERIORITY||Mean Difference (Net)|-0.012||||0.889|TWO_SIDED|95.0|-0.182|0.158|||ANCOVA|||A mixed model of analysis of covariance (ANCOVA) was used with change from baseline at Week 48 as the response, and participants, eyes of the participant as random factor, treatment and baseline LogMAR value as covariates in the model. P-value is used to assess the significance of the difference between All-GS010 and All-Sham with respect to change of LogMAR from baseline.||0.158|-0.182|0.8890
72380533|NCT02797054|144269557|OTHER|||||||0.069|||||||Chi-squared|||||||0.069
72380534|NCT02797054|144269558|OTHER|||||||0.303|||||||Chi-squared|||||||0.303
72380535|NCT02797054|144269559|OTHER|||||||0.001|||||||Chi-squared|||||||0.001
72380536|NCT02797054|144269560|OTHER|||||||0.895|||||||Chi-squared|||||||0.895
72380537|NCT02797054|144269561|OTHER|||||||0.58|||||||Chi-squared|||||||0.58
72380538|NCT02797054|144269562|OTHER|||||||0.0015|||||||Chi-squared|||||||0.0015
72380539|NCT02797054|144269563|OTHER|||||||0.0056|||||||Chi-squared|||||||0.0056
72380540|NCT02797054|144269564|OTHER|||||||0.21|||||||Chi-squared|||||||0.21
72380541|NCT04644783|144269565|SUPERIORITY||||||<|0.0001|||||||Regression, non-linear mixed effects|||||||<0.0001
72380542|NCT04644783|144269566|SUPERIORITY||||||<|0.0001|||||||Regression, non-linear mixed effects|||||||<0.0001
72380543|NCT01476644|144269577|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.01|||||||Regression, Linear|||||||<0.01
72380544|NCT00495131|144269592|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||Null hypothesis: no difference between 2 groups SVR estimation: 24 weeks (60%), 48 weeks (75%) alfa erros: 0.05, power: 0.80||||< 0.001
72380545|NCT00744471|144269595|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) Mean Difference|-1.28|STANDARD_ERROR_OF_MEAN|0.3|<|0.001|TWO_SIDED|95.0|-1.87|-0.69||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 16: Analysis of Covariance (ANCOVA) was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-0.69|-1.87|<0.001
72380546|NCT00744471|144269595|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.69|STANDARD_ERROR_OF_MEAN|0.3|<|0.001|TWO_SIDED|95.0|-2.28|-1.1||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 16: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-1.10|-2.28|<0.001
72380547|NCT00744471|144269595|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.75|STANDARD_ERROR_OF_MEAN|0.3|<|0.001|TWO_SIDED|95.0|-2.34|-1.16||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 16: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-1.16|-2.34|<0.001
72556458|NCT01058668|144644163|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-6.1|||<|0.001|TWO_SIDED|95.0|-8.4|-3.8|||Mixed Models Analysis||cariprazine (3-6 mg/day) - placebo|||-3.8|-8.4|<0.001
72556459|NCT01058668|144644163|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-5.9|||<|0.001|TWO_SIDED|95.0|-8.2|-3.6|||Mixed Models Analysis||cariprazine (6-12 mg/day) - placebo|||-3.6|-8.2|<0.001
72556460|NCT01058668|144644164|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.6|||<|0.001|TWO_SIDED|95.0|-0.9|-0.4|||Mixed Models Analysis||cariprazine (3-6 mg/day) - placebo|||-0.4|-0.9|<0.001
72556461|NCT01058668|144644164|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.6|||<|0.001|TWO_SIDED|95.0|-0.9|-0.3|||Mixed Models Analysis||cariprazine (6-12 mg/day) - placebo|||-0.3|-0.9|<0.001
72380548|NCT00744471|144269596|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.18|STANDARD_ERROR_OF_MEAN|0.29|<|0.001|TWO_SIDED|95.0|-1.74|-0.61||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 16: ANCOVA was performed with treatment as main effects, baseline value, as a covariate, and study site as a random effect.||-0.61|-1.74|<0.001
72380549|NCT00744471|144269596|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.49|STANDARD_ERROR_OF_MEAN|0.29|<|0.001|TWO_SIDED|95.0|-2.06|-0.92||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 16: ANCOVA model includes treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.92|-2.06|<0.001
72380550|NCT00744471|144269596|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.61|STANDARD_ERROR_OF_MEAN|0.29|<|0.001|TWO_SIDED|95.0|-2.17|-1.04||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 16: ANCOVA model includes treatment as main effects, baseline value as a covariate, and study site as a random effect.||-1.04|-2.17|<0.001
72380551|NCT00744471|144269597|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.32|STANDARD_ERROR_OF_MEAN|0.1||0.001|TWO_SIDED|95.0|-0.51|-0.13||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 16: ANCOVA model includes treatment as main effect, baseline value as a covariate, and study site as a random effect.||-0.13|-0.51|0.001
72380552|NCT00744471|144269597|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.45|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.64|-0.25||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 16: ANCOVA model includes treatment as main effect, baseline value as a covariate, and study site as a random effect.||-0.25|-0.64|<0.001
72380553|NCT00744471|144269597|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.47|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.66|-0.28||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 16: ANCOVA model includes treatment as main effect, baseline value as a covariate, and study site as a random effect.||-0.28|-0.66|<0.001
72380554|NCT00744471|144269598|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.41|STANDARD_ERROR_OF_MEAN|0.27|<|0.001|TWO_SIDED|95.0|-1.93|-0.88||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 2: ANCOVA model includes treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.88|-1.93|<0.001
72380555|NCT00744471|144269598|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.73|STANDARD_ERROR_OF_MEAN|0.27|<|0.001|TWO_SIDED|95.0|-2.26|-1.2||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 2: ANCOVA model includes treatment as main effects, baseline value as a covariate, and study site as a random effect.||-1.20|-2.26|<0.001
72380556|NCT00744471|144269598|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.33|STANDARD_ERROR_OF_MEAN|0.27|<|0.001|TWO_SIDED|95.0|-1.85|-0.8||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 2: ANCOVA model includes treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.80|-1.85|<0.001
72380557|NCT00744471|144269598|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.57|STANDARD_ERROR_OF_MEAN|0.28|<|0.001|TWO_SIDED|95.0|-2.11|-1.02||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 4: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-1.02|-2.11|<0.001
72380558|NCT00744471|144269598|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-2.03|STANDARD_ERROR_OF_MEAN|0.28|<|0.001|TWO_SIDED|95.0|-2.57|-1.48||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 4: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-1.48|-2.57|<0.001
72556462|NCT01068821|144644165|SUPERIORITY_OR_OTHER|||||||0.1|TWO_SIDED|95.0|||||t-test, 2 sided|||Sample size calculations (yielding 25 patients per group): two-sided 5% significance level and a power of 80% for detection of a 2 cm (SD 2.5 cm) difference. Continuous variables analyzed by Student's T-test and One way Analysis of Variance (ANOVA) with statistical significance: p value ≤ 0.05 or 95% Confidence Interval excluding one. Confirmation by Wilcoxon Rank-Sum/Mann-Whitney and Kruskal-Wallis tests. Categorical variables by Chi Square Test, confirmed by Fisher's Exact test.||||0.1
72380559|NCT00744471|144269598|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.95|STANDARD_ERROR_OF_MEAN|0.28|<|0.001|TWO_SIDED|95.0|-2.5|-1.41||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 4: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-1.41|-2.50|<0.001
72380560|NCT00744471|144269598|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.09|STANDARD_ERROR_OF_MEAN|0.28|<|0.001|TWO_SIDED|95.0|-1.65|-0.53||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 8: ANCOVA model was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.53|-1.65|<0.001
72380561|NCT00744471|144269598|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.64|STANDARD_ERROR_OF_MEAN|0.29|<|0.001|TWO_SIDED|95.0|-2.2|-1.08||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 8: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-1.08|-2.20|<0.001
72380562|NCT00744471|144269598|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-2.0|STANDARD_ERROR_OF_MEAN|0.28|<|0.001|TWO_SIDED|95.0|-2.56|-1.45||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 8: ANCOVA model was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-1.45|-2.56|<0.001
72493945|NCT03178487|144516788|OTHER||LS Mean Difference|-3.69|||<|0.001|TWO_SIDED|95.0|-5.31|-2.08||This comparison was not part of the pre-specified multiplicity testing sequence.|ANCOVA|ANCOVA model including treatment and Screening hsCRP level as fixed factors and Baseline value as covariate.|Treatment difference = Upadacitinib - Placebo|||-2.08|-5.31|<0.001
72380563|NCT00744471|144269598|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.49|STANDARD_ERROR_OF_MEAN|0.31|<|0.001|TWO_SIDED|95.0|-2.1|-0.88||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 12: ANCOVA model was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.88|-2.10|<0.001
72493946|NCT03178487|144516789|OTHER||LS Mean Difference|-6.21|||<|0.001|TWO_SIDED|95.0|-8.27|-4.14|||ANCOVA|ANCOVA model including treatment and Screening hsCRP level as fixed factors and Baseline value as covariate.|Treatment difference = Upadacitinib - Placebo|||-4.14|-8.27|<0.001
72380564|NCT00744471|144269598|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.85|STANDARD_ERROR_OF_MEAN|0.31|<|0.001|TWO_SIDED|95.0|-2.46|-1.25||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 12: ANCOVA model was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-1.25|-2.46|<0.001
72380565|NCT00744471|144269598|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.97|STANDARD_ERROR_OF_MEAN|0.31|<|0.001|TWO_SIDED|95.0|-2.57|-1.37||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 12: ANCOVA model was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-1.37|-2.57|<0.001
72380566|NCT00744471|144269598|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.16|STANDARD_ERROR_OF_MEAN|0.3|<|0.001|TWO_SIDED|95.0|-1.75|-0.56||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 24: ANCOVA model was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.56|-1.75|<0.001
72380567|NCT00744471|144269598|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.52|STANDARD_ERROR_OF_MEAN|0.3|<|0.001|TWO_SIDED|95.0|-2.12|-0.92||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 24: ANCOVA model was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.92|-2.12|<0.001
72380568|NCT00744471|144269598|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.6|STANDARD_ERROR_OF_MEAN|0.3|<|0.001|TWO_SIDED|95.0|-2.2|-1.01||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 24: ANCOVA model was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-1.01|-2.20|<0.001
72380569|NCT00744471|144269599|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.41|STANDARD_ERROR_OF_MEAN|0.27|<|0.001|TWO_SIDED|95.0|-1.93|-0.88||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 2: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.88|-1.93|<0.001
72380570|NCT00744471|144269599|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.73|STANDARD_ERROR_OF_MEAN|0.27|<|0.001|TWO_SIDED|95.0|-2.26|-1.2||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 2: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-1.20|-2.26|<0.001
72380571|NCT00744471|144269599|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.33|STANDARD_ERROR_OF_MEAN|0.27|<|0.001|TWO_SIDED|95.0|-1.85|-0.8||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 2: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.80|-1.85|<0.001
72380572|NCT00744471|144269599|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.55|STANDARD_ERROR_OF_MEAN|0.27|<|0.001|TWO_SIDED|95.0|-2.08|-1.02||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 4: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-1.02|-2.08|<0.001
72380573|NCT00744471|144269599|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.99|STANDARD_ERROR_OF_MEAN|0.27|<|0.001|TWO_SIDED|95.0|-2.52|-1.46||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 4: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-1.46|-2.52|<0.001
72380574|NCT00744471|144269599|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-2.01|STANDARD_ERROR_OF_MEAN|0.27|<|0.001|TWO_SIDED|95.0|-2.54|-1.48||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 4: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-1.48|-2.54|<0.001
72493947|NCT03178487|144516790|OTHER||LS Mean Difference|-2.55|||<|0.001|TWO_SIDED|95.0|-4.01|-1.08|||ANCOVA|ANCOVA model including treatment and Screening hsCRP level as fixed factors and Baseline value as covariate.|Treatment difference = Upadacitinib - Placebo|||-1.08|-4.01|<0.001
72618571|NCT01026038|144768105|SUPERIORITY_OR_OTHER|||||||0.608||95.0|||||Fisher Exact|||Fever (\>=39 degree C to \<=40 degree C): Fisher exact test, 2-sided was used. Pairwise comparison was made between 7vPnC/7vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.||||0.608
72380575|NCT00744471|144269599|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.17|STANDARD_ERROR_OF_MEAN|0.28|<|0.001|TWO_SIDED|95.0|-1.71|-0.63||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 8: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.63|-1.71|<0.001
72380576|NCT00744471|144269599|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.66|STANDARD_ERROR_OF_MEAN|0.28|<|0.001|TWO_SIDED|95.0|-2.21|-1.12||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 8: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-1.12|-2.21|<0.001
72380577|NCT00744471|144269599|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-2.06|STANDARD_ERROR_OF_MEAN|0.27|<|0.001|TWO_SIDED|95.0|-2.6|-1.52||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 8: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-1.52|-2.60|<0.001
72380578|NCT00744471|144269599|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.55|STANDARD_ERROR_OF_MEAN|0.29|<|0.001|TWO_SIDED|95.0|-2.11|-0.99||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 12: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.99|-2.11|<0.001
72380579|NCT00744471|144269599|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.88|STANDARD_ERROR_OF_MEAN|0.29|<|0.001|TWO_SIDED|95.0|-2.45|-1.32||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 12: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-1.32|-2.45|<0.001
72380580|NCT00744471|144269599|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-2.26|STANDARD_ERROR_OF_MEAN|0.28|<|0.001|TWO_SIDED|95.0|-2.82|-1.7||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 12: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-1.70|-2.82|<0.001
72380581|NCT00744471|144269599|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.27|STANDARD_ERROR_OF_MEAN|0.28|<|0.001|TWO_SIDED|95.0|-1.82|-0.71||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 16: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.71|-1.82|<0.001
72556463|NCT01068821|144644166|SUPERIORITY_OR_OTHER|||||||0.5||95.0|||||Fisher Exact|||Fischer's exact test, significance defined as p\<0.05||||0.5
72380582|NCT00744471|144269599|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.59|STANDARD_ERROR_OF_MEAN|0.28|<|0.001|TWO_SIDED|95.0|-2.15|-1.03||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 16: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-1.03|-2.15|<0.001
72380583|NCT00744471|144269599|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.96|STANDARD_ERROR_OF_MEAN|0.28|<|0.001|TWO_SIDED|95.0|-2.51|-1.4||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 16: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-1.40|-2.51|<0.001
72380584|NCT00744471|144269599|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.29|STANDARD_ERROR_OF_MEAN|0.29|<|0.001|TWO_SIDED|95.0|-1.85|-0.72||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 24: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.72|-1.85|<0.001
72380585|NCT00744471|144269599|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.58|STANDARD_ERROR_OF_MEAN|0.29|<|0.001|TWO_SIDED|95.0|-2.15|-1.01||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 24: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-1.01|-2.15|<0.001
72380586|NCT00744471|144269599|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.83|STANDARD_ERROR_OF_MEAN|0.29|<|0.001|TWO_SIDED|95.0|-2.4|-1.27||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 24: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-1.27|-2.40|<0.001
72380587|NCT00744471|144269600|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.31|STANDARD_ERROR_OF_MEAN|0.26|<|0.001|TWO_SIDED|95.0|-1.83|-0.8||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 2: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-0.80|-1.83|<0.001
72380588|NCT00744471|144269600|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.71|STANDARD_ERROR_OF_MEAN|0.26|<|0.001|TWO_SIDED|95.0|-2.23|-1.19||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 2: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-1.19|-2.23|<0.001
72380589|NCT00744471|144269600|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.32|STANDARD_ERROR_OF_MEAN|0.26|<|0.001|TWO_SIDED|95.0|-1.83|-0.8||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 2: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-0.80|-1.83|<0.001
72380590|NCT00744471|144269600|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.6|STANDARD_ERROR_OF_MEAN|0.26|<|0.001|TWO_SIDED|95.0|-2.12|-1.08||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 4: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-1.08|-2.12|<0.001
72380591|NCT00744471|144269600|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-2.12|STANDARD_ERROR_OF_MEAN|0.26|<|0.001|TWO_SIDED|95.0|-2.64|-1.6||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 4: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-1.60|-2.64|<0.001
72380592|NCT00744471|144269600|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.94|STANDARD_ERROR_OF_MEAN|0.26|<|0.001|TWO_SIDED|95.0|-2.46|-1.43||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 4: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-1.43|-2.46|<0.001
72380593|NCT00744471|144269600|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.18|STANDARD_ERROR_OF_MEAN|0.28|<|0.001|TWO_SIDED|95.0|-1.72|-0.64||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 8: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-0.64|-1.72|<0.001
72380594|NCT00744471|144269600|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.64|STANDARD_ERROR_OF_MEAN|0.28|<|0.001|TWO_SIDED|95.0|-2.18|-1.09||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 8: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-1.09|-2.18|<0.001
72380595|NCT00744471|144269600|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.89|STANDARD_ERROR_OF_MEAN|0.27|<|0.001|TWO_SIDED|95.0|-2.43|-1.35||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 8: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-1.35|-2.43|<0.001
72380596|NCT00744471|144269600|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.35|STANDARD_ERROR_OF_MEAN|0.3|<|0.001|TWO_SIDED|95.0|-1.93|-0.77||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 12: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-0.77|-1.93|<0.001
72380597|NCT00744471|144269600|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-1.73|STANDARD_ERROR_OF_MEAN|0.3|<|0.001|TWO_SIDED|95.0|-2.31|-1.15||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 12 :Analysis of Covariance (ANCOVA) was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-1.15|-2.31|<0.001
72380598|NCT00744471|144269600|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.89|STANDARD_ERROR_OF_MEAN|0.29|<|0.001|TWO_SIDED|95.0|-2.47|-1.32||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 12: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-1.32|-2.47|<0.001
72380599|NCT00744471|144269600|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.96|STANDARD_ERROR_OF_MEAN|0.29|<|0.001|TWO_SIDED|95.0|-1.52|-0.4||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 24 : ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-0.40|-1.52|<0.001
72380600|NCT00744471|144269600|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.35|STANDARD_ERROR_OF_MEAN|0.29|<|0.001|TWO_SIDED|95.0|-1.91|-0.78||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 24 :Analysis of Covariance (ANCOVA) was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-0.78|-1.91|<0.001
72380601|NCT00744471|144269600|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.53|STANDARD_ERROR_OF_MEAN|0.28|<|0.001|TWO_SIDED|95.0|-2.09|-0.97||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 24 :Analysis of Covariance (ANCOVA) was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-0.97|-2.09|<0.001
72380602|NCT00744471|144269601|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.31|STANDARD_ERROR_OF_MEAN|0.26|<|0.001|TWO_SIDED|95.0|-1.83|-0.8||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 2: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-0.80|-1.83|<0.001
72380603|NCT00744471|144269601|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.71|STANDARD_ERROR_OF_MEAN|0.26|<|0.001|TWO_SIDED|95.0|-2.23|-1.19||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 2: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-1.19|-2.23|<0.001
72380604|NCT00744471|144269601|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.32|STANDARD_ERROR_OF_MEAN|0.26|<|0.001|TWO_SIDED|95.0|-1.83|-0.8||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 2: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-0.80|-1.83|<0.001
72380605|NCT00744471|144269601|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.59|STANDARD_ERROR_OF_MEAN|0.26|<|0.001|TWO_SIDED|95.0|-2.1|-1.08|||ANCOVA|||Change at Week 4: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-1.08|-2.10|<0.001
72380606|NCT00744471|144269601|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-2.1|STANDARD_ERROR_OF_MEAN|0.26|<|0.001|TWO_SIDED|95.0|-2.61|-1.59||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 4: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-1.59|-2.61|<0.001
72556464|NCT04859517|144644167|SUPERIORITY||Risk Difference (RD)|-5.0||||0.0123|TWO_SIDED|95.0|-8.87|-1.08|||Regression, Logistic||||A statistical method described in Ge et al. (2011) was used to compute a population-level estimate for the treatment difference (in terms of difference in proportion) with adjustment for the pre-defined prognostic factors. The variance of the estimated treatment difference or relative risk reduction was estimated using the delta method.|-1.08|-8.87|0.0123
72556465|NCT04859517|144644168|SUPERIORITY||Risk Difference (RD)|-3.9|||<|0.0001|TWO_SIDED|95.0|-5.75|-2.01|||Regression, Logistic|||||-2.01|-5.75|<0.0001
72380607|NCT00744471|144269601|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-2.0|STANDARD_ERROR_OF_MEAN|0.26|<|0.001|TWO_SIDED|95.0|-2.51|-1.49||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 4: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-1.49|-2.51|<0.001
72380608|NCT00744471|144269601|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.29|STANDARD_ERROR_OF_MEAN|0.27|<|0.001|TWO_SIDED|95.0|-1.83|-0.76||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 8: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-0.76|-1.83|<0.001
72380609|NCT00744471|144269601|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.72|STANDARD_ERROR_OF_MEAN|0.27|<|0.001|TWO_SIDED|95.0|-2.26|-1.19||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 8: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-1.19|-2.26|<0.001
72380610|NCT00744471|144269601|SUPERIORITY_OR_OTHER_LEGACY||Slope|-1.99|STANDARD_ERROR_OF_MEAN|0.27|<|0.001|TWO_SIDED|95.0|-2.53|-1.46||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 8: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-1.46|-2.53|<0.001
72380611|NCT00744471|144269601|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.56|STANDARD_ERROR_OF_MEAN|0.28|<|0.001|TWO_SIDED|95.0|-2.11|-1.0||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 12: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-1.00|-2.11|<0.001
72380612|NCT00744471|144269601|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-1.93|STANDARD_ERROR_OF_MEAN|0.29|<|0.001|TWO_SIDED|95.0|-2.49|-1.37||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 12: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-1.37|-2.49|<0.001
72380613|NCT00744471|144269601|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-2.28|STANDARD_ERROR_OF_MEAN|0.28|<|0.001|TWO_SIDED|95.0|-2.83|-1.72||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 12: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-1.72|-2.83|<0.001
72380614|NCT00744471|144269601|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.31|STANDARD_ERROR_OF_MEAN|0.28|<|0.001|TWO_SIDED|95.0|-1.87|-0.75||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 16: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-0.75|-1.87|<0.001
72380615|NCT00744471|144269601|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.58|STANDARD_ERROR_OF_MEAN|0.29|<|0.001|TWO_SIDED|95.0|-2.14|-1.02||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 16: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-1.02|-2.14|<0.001
72380616|NCT00744471|144269601|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.92|STANDARD_ERROR_OF_MEAN|0.28|<|0.001|TWO_SIDED|95.0|-2.47|-1.36||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 16: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-1.36|-2.47|<0.001
72380617|NCT00744471|144269601|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.3|STANDARD_ERROR_OF_MEAN|0.28|<|0.001|TWO_SIDED|95.0|-1.86|-0.74||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 24: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-0.74|-1.86|<0.001
72380618|NCT00744471|144269601|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.61|STANDARD_ERROR_OF_MEAN|0.28|<|0.001|TWO_SIDED|95.0|-2.17|-1.05||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 24: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-1.05|-2.17|<0.001
72618572|NCT01026038|144768105|SUPERIORITY_OR_OTHER||||||>|0.99||95.0|||||Fisher Exact|||Fever (\>=39 degree C to \<=40 degree C): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.||||>0.990
72618573|NCT01026038|144768105|SUPERIORITY_OR_OTHER||||||>|0.99||95.0|||||Fisher Exact|||Fever (\>40 degree C): Fisher exact test, 2-sided was used. Pairwise comparison was made between 7vPnC/7vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.||||>0.990
72380619|NCT00744471|144269601|SUPERIORITY_OR_OTHER_LEGACY||Slope|-1.91|STANDARD_ERROR_OF_MEAN|0.28|<|0.001|TWO_SIDED|95.0|-2.47|-1.36||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 24: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-1.36|-2.47|<0.001
72380620|NCT00744471|144269602|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.37|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.55|-0.18||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 2: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-0.18|-0.55|<0.001
72380621|NCT00744471|144269602|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.64|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.83|-0.45||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 2: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-0.45|-0.83|<0.001
72380622|NCT00744471|144269602|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.41|STANDARD_ERROR_OF_MEAN|0.09|<|0.001|TWO_SIDED|95.0|-0.6|-0.22||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 2: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-0.22|-0.60|<0.001
72380623|NCT00744471|144269602|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.46|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.65|-0.27||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 4: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-0.27|-0.65|<0.001
72380624|NCT00744471|144269602|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.69|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.88|-0.5||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 4: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-0.50|-0.88|<0.001
72380625|NCT00744471|144269602|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.55|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.73|-0.36||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 4: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-0.36|-0.73|<0.001
72380626|NCT00744471|144269602|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.1||0.054|TWO_SIDED|95.0|-0.39|0.0||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 8: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||0.00|-0.39|0.054
72380627|NCT00744471|144269602|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.48|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.68|-0.29||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 8: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-0.29|-0.68|<0.001
72380628|NCT00744471|144269602|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.45|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.65|-0.26||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 8: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-0.26|-0.65|<0.001
72380629|NCT00744471|144269602|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.35|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.55|-0.15||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 12: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-0.15|-0.55|<0.001
72380630|NCT00744471|144269602|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.61|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.81|-0.4||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 12: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-0.40|-0.81|<0.001
72380631|NCT00744471|144269602|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.53|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.73|-0.32||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 12: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-0.32|-0.73|<0.001
72556466|NCT04859517|144644171|SUPERIORITY||Standardized Risk Difference|-7.6||||0.0153|TWO_SIDED|95.0|-13.74|-1.46|||Regression, Logistic||||A statistical method described in Ge et al. (2011) was used to compute a population-level estimate for the treatment difference (in terms of difference in proportion) with adjustment for the pre-defined prognostic factors. The variance of the estimated treatment difference or relative risk reduction was estimated using the delta method.|-1.46|-13.74|0.0153
72380632|NCT00744471|144269602|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.26|STANDARD_ERROR_OF_MEAN|0.1||0.008|TWO_SIDED|95.0|-0.45|-0.07||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 24: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-0.07|-0.45|0.008
72380633|NCT00744471|144269602|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.41|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.6|-0.22||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 24: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-0.22|-0.60|<0.001
72380634|NCT00744471|144269602|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.24|STANDARD_ERROR_OF_MEAN|0.1||0.012|TWO_SIDED|95.0|-0.43|-0.05||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 24: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-0.05|-0.43|0.012
72380635|NCT00744471|144269603|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.37|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.55|-0.18||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 2: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-0.18|-0.55|<0.001
72380636|NCT00744471|144269603|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.64|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.83|-0.45||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 2: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-0.45|-0.83|<0.001
72618574|NCT01026038|144768105|SUPERIORITY_OR_OTHER|||||||0.333||95.0|||||Fisher Exact|||Fever (\>40 degree C): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.||||0.333
72380637|NCT00744471|144269603|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.41|STANDARD_ERROR_OF_MEAN|0.09|<|0.001|TWO_SIDED|95.0|-0.6|-0.22||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 2: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-0.22|-0.60|<0.001
72380638|NCT00744471|144269603|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.46|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.65|-0.27||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 4: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-0.27|-0.65|<0.001
72380639|NCT00744471|144269603|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.68|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.87|-0.5||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 4: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-0.50|-0.87|<0.001
72380640|NCT00744471|144269603|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.58|STANDARD_ERROR_OF_MEAN|0.09|<|0.001|TWO_SIDED|95.0|-0.76|-0.39||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 4: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-0.39|-0.76|<0.001
72380641|NCT00744471|144269603|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.23|STANDARD_ERROR_OF_MEAN|0.1||0.022|TWO_SIDED|95.0|-0.43|-0.03||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 8: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-0.03|-0.43|0.022
72380642|NCT00744471|144269603|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.47|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.67|-0.27||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 8: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-0.27|-0.67|<0.001
72380643|NCT00744471|144269603|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.46|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.65|-0.26||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 8: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-0.26|-0.65|<0.001
72380644|NCT00744471|144269603|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.6|-0.19||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 12: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-0.19|-0.60|<0.001
72380645|NCT00744471|144269603|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.68|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.88|-0.47||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 12: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-0.47|-0.88|<0.001
72380646|NCT00744471|144269603|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.59|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.79|-0.39||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 12: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-0.39|-0.79|<0.001
72380647|NCT00744471|144269603|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.33|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.53|-0.14||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 16: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-0.14|-0.53|<0.001
72380648|NCT00744471|144269603|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.48|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.68|-0.28||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 16: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-0.28|-0.68|<0.001
72556467|NCT04859517|144644172|SUPERIORITY||Risk Difference (RD)|-4.4||||0.0612|TWO_SIDED|95.0|-9.03|0.21|||Regression, Logistic||||A statistical method described in Ge et al. (2011) was used to compute a population-level estimate for the treatment difference (in terms of difference in proportion) with adjustment for the pre-defined prognostic factors. The variance of the estimated treatment difference or relative risk reduction was estimated using the delta method.|0.21|-9.03|0.0612
72380649|NCT00744471|144269603|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.51|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.71|-0.32||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 16: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-0.32|-0.71|<0.001
72380650|NCT00744471|144269603|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.27|STANDARD_ERROR_OF_MEAN|0.1||0.01|TWO_SIDED|95.0|-0.47|-0.06||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 24: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-0.06|-0.47|0.010
72380651|NCT00744471|144269603|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.46|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.66|-0.25||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 24: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-0.25|-0.66|<0.001
72556468|NCT04859517|144644191|SUPERIORITY||Hazard Ratio (HR)|0.22||||0.0077|TWO_SIDED|95.0|0.06|0.76|||Log Rank|||||0.76|0.06|0.0077
72380652|NCT00744471|144269603|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.33|STANDARD_ERROR_OF_MEAN|0.1||0.001|TWO_SIDED|95.0|-0.53|-0.13||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 24: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-0.13|-0.53|0.001
72380653|NCT04706416|144269627|SUPERIORITY||Odds Ratio (OR)|0.6||||0.297|TWO_SIDED|95.0|0.26|1.48|||Fisher Exact|||||1.48|0.26|0.297
72380654|NCT04706416|144269627|SUPERIORITY||Odds Ratio (OR)|0.68||||0.541|TWO_SIDED|95.0|0.19|2.3|||Regression, Logistic|||||2.30|0.19|0.541
72380655|NCT04706416|144269628|SUPERIORITY||Odds Ratio (OR)|0.37||||0.039|TWO_SIDED|95.0|0.15|0.91|||Fisher Exact|||||0.91|0.15|0.039
72380656|NCT04706416|144269628|SUPERIORITY||Odds Ratio (OR)|0.34||||0.081|TWO_SIDED|95.0|0.09|1.07|||Regression, Logistic|||||1.07|0.09|0.081
72380657|NCT04706416|144269629|SUPERIORITY||Hodges-Lehmann estimator|0.0||||0.643|TWO_SIDED|95.0|-1.0|3.0|||Wilcoxon (Mann-Whitney)|||||3.0|-1.0|0.643
72380658|NCT04706416|144269629|SUPERIORITY||β-coefficient|-4.27||||0.001|TWO_SIDED|95.0|-5.67|-2.87|||Regression, Linear|||||-2.87|-5.67|0.001
72556469|NCT04859517|144644192|SUPERIORITY||Hazard Ratio (HR)|0.27|||<|0.0001|TWO_SIDED|95.0|0.14|0.49|||Log Rank|||||0.49|0.14|<0.0001
72380659|NCT04706416|144269630|SUPERIORITY||Odds Ratio (OR)|0.53||||0.133|TWO_SIDED|95.0|0.25|1.19|||Fisher Exact|||||1.19|0.25|0.133
72380660|NCT04706416|144269631|SUPERIORITY||Hodges-Lehmann estimator|4.0||||0.092|TWO_SIDED|95.0|-1.0|12.0|||Wilcoxon (Mann-Whitney)|||||12.0|-1.0|0.092
72380661|NCT04706416|144269632|SUPERIORITY||Hodges-Lehmann estimator|0.0||||0.834|TWO_SIDED|95.0|-2.0|2.0|||Wilcoxon (Mann-Whitney)|||||2.0|-2.0|0.834
72380662|NCT04706416|144269633|SUPERIORITY||Odds Ratio (OR)|0.001||||0.149|TWO_SIDED|95.0|0.0|1.52|||Fisher Exact|||||1.52|0|0.149
72380663|NCT04706416|144269634|SUPERIORITY||Odds Ratio (OR)|0.3||||0.015|TWO_SIDED|95.0|0.12|0.8|||Fisher Exact|||||0.80|0.12|0.015
72380664|NCT01539317|144269640|SUPERIORITY_OR_OTHER|||||||0.0149|||||||Wilcoxon (Mann-Whitney)|||Phase II: During Blinded 4 weeks||||0.0149
72380665|NCT01539317|144269640|SUPERIORITY_OR_OTHER|||||||0.412|||||||Wilcoxon (Mann-Whitney)|||Phase III||||0.412
72556470|NCT01642277|144644197|SUPERIORITY_OR_OTHER||Standardized test statistic (z-score)|-1.94||||0.052|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||For symptom-severity score, the non-parametric Mann-Whitney test was used to compare the responder and non-responder groups due to low sample size and non-normal distributions of symptom severity scores. The null hypothesis is that there is no difference between the two groups in symptom severity, and the two-sided alternative hypothesis is that one of the two groups has higher (or lower) symptom severity than the other group.||||.052
72618575|NCT01026038|144768105|SUPERIORITY_OR_OTHER|||||||0.215||95.0|||||Fisher Exact|||Vomiting (Any): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/7vPnC/13vPnC.||||0.215
72618576|NCT01026038|144768105|SUPERIORITY_OR_OTHER|||||||0.714||95.0|||||Fisher Exact|||Vomiting (Any): Fisher exact test, 2-sided was used. Pairwise comparison was made between 7vPnC/7vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.||||0.714
72380666|NCT01539317|144269641|SUPERIORITY_OR_OTHER|||||||0.66|||||||Wilcoxon (Mann-Whitney)|||Desire||||0.66
72618577|NCT01026038|144768105|SUPERIORITY_OR_OTHER|||||||0.397||95.0|||||Fisher Exact|||Vomiting (Any): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.||||0.397
72618578|NCT01026038|144768105|SUPERIORITY_OR_OTHER|||||||0.215||95.0|||||Fisher Exact|||Vomiting (Mild): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/7vPnC/13vPnC.||||0.215
72380667|NCT01539317|144269641|SUPERIORITY_OR_OTHER|||||||0.11|||||||Wilcoxon (Mann-Whitney)|||Arousal (S)||||0.11
72380668|NCT01539317|144269641|SUPERIORITY_OR_OTHER|||||||0.15|||||||Wilcoxon (Mann-Whitney)|||Arousal (L)||||0.15
72380669|NCT01539317|144269641|SUPERIORITY_OR_OTHER|||||||0.28|||||||Wilcoxon (Mann-Whitney)|||Arousal (C)||||0.28
72380670|NCT01539317|144269641|SUPERIORITY_OR_OTHER|||||||0.07|||||||Wilcoxon (Mann-Whitney)|||Orgasm||||0.07
72380671|NCT01539317|144269641|SUPERIORITY_OR_OTHER|||||||0.004|||||||Wilcoxon (Mann-Whitney)|||Pain||||0.004
72380672|NCT01539317|144269641|SUPERIORITY_OR_OTHER|||||||0.54|||||||Wilcoxon (Mann-Whitney)|||Enjoyment||||0.54
72380673|NCT01539317|144269641|SUPERIORITY_OR_OTHER|||||||0.92|||||||Wilcoxon (Mann-Whitney)|||Partner||||0.92
72380674|NCT01539317|144269642|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Each of 8 site comparisons had its own P-value and a value of \<0.001 was the difference at the most tender sites|Wilcoxon (Mann-Whitney)|||||||<0.001
72380675|NCT01876810|144269667|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|0.1||0.1|TWO_SIDED|95.0||||For all analyses, results are considered significant at p\<.05.|t-test, 2 sided|||||||0.1
72380676|NCT01876810|144269667|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.0||0.1|TWO_SIDED|95.0||||For all analyses, results were considered significant at p\< 0.05|t-test, 2 sided|||||||0.1
72380677|NCT01876810|144269668|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.77|STANDARD_ERROR_OF_MEAN|0.034||0.9|TWO_SIDED|95.0||||For all analyses, results were considered significant at p\< 0.05|t-test, 2 sided|||||||0.9
72380678|NCT01876810|144269668|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.77|STANDARD_ERROR_OF_MEAN|0.05||0.9|TWO_SIDED|95.0||||For all analyses, results were considered significant at p\< 0.05|t-test, 2 sided|||||||0.9
72380679|NCT01876810|144269669|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|51.3|STANDARD_ERROR_OF_MEAN|31.7||0.4|TWO_SIDED|95.0|||||ANOVA|Repeated-measures ANOVA on Drug X Cue X Time were used|participants self-reportd VAS craving at the time of neutral cue presentation|||||0.4
72380680|NCT01876810|144269669|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|43.7|STANDARD_ERROR_OF_MEAN|26.5||0.4|TWO_SIDED|95.0||||For all analyses, results were considered significant at p\< 0.05|ANOVA|Repeated-measures ANOVA on Drug X Cue X Time were used||||||0.4
72380681|NCT00749580|144269711|SUPERIORITY_OR_OTHER|||||||0.935|||||||Fisher Exact|||||||0.935
72380682|NCT00905827|144269713|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||ANOVA|||Pairwise comparisons (ANOVA simple effect comparisons) adjusted for baseline scores||||<0.01
72380683|NCT00905827|144269713|SUPERIORITY_OR_OTHER|||||||0.01|TWO_SIDED||||||ANOVA|||Pairwise comparisons (ANOVA simple effect comparisons) adjusted for baseline scores||||0.01
72380684|NCT00509392|144269715|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||||||<0.0001
72380685|NCT00509392|144269716|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||||||<0.0001
72380686|NCT00509392|144269717|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||||||<0.0001
72380687|NCT00509392|144269718|SUPERIORITY_OR_OTHER|||||||0.2962||95.0|||||t-test, 2 sided|||||||0.2962
72380688|NCT00509392|144269719|SUPERIORITY_OR_OTHER|||||||0.0048||95.0|||||t-test, 2 sided|||||||0.0048
72380689|NCT00509392|144269720|SUPERIORITY_OR_OTHER|||||||0.0036||95.0|||||t-test, 2 sided|||||||0.0036
72380690|NCT00509392|144269721|SUPERIORITY_OR_OTHER|||||||0.0005||95.0|||||t-test, 2 sided|||||||0.0005
72380691|NCT00509392|144269722|SUPERIORITY_OR_OTHER|||||||0.5761||95.0|||||t-test, 2 sided|||||||0.5761
72380692|NCT00509392|144269723|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Fisher Exact|||||||<0.0001
72380693|NCT00509392|144269724|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Fisher Exact|||||||<0.0001
72380694|NCT00509392|144269725|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Fisher Exact|||||||<0.0001
72380695|NCT00509392|144269726|SUPERIORITY_OR_OTHER|||||||0.005||95.0|||||Fisher Exact|||||||0.0050
72380696|NCT00509392|144269728|SUPERIORITY_OR_OTHER|||||||0.0009||95.0|||||t-test, 2 sided|||||||0.0009
72380697|NCT00509392|144269729|SUPERIORITY_OR_OTHER|||||||0.0002||95.0|||||t-test, 2 sided|||||||0.0002
72380698|NCT00509392|144269730|SUPERIORITY_OR_OTHER|||||||0.0035||95.0|||||t-test, 2 sided|||||||0.0035
72380699|NCT00509392|144269731|SUPERIORITY_OR_OTHER|||||||0.2825||95.0|||||t-test, 2 sided|||||||0.2825
72380700|NCT00509392|144269732|SUPERIORITY_OR_OTHER|||||||0.0854||95.0|||||t-test, 2 sided|||||||0.0854
72380701|NCT00509392|144269733|SUPERIORITY_OR_OTHER|||||||0.0044||95.0|||||t-test, 2 sided|||||||0.0044
72380702|NCT00509392|144269734|SUPERIORITY_OR_OTHER|||||||0.0457||95.0|||||t-test, 2 sided|||||||0.0457
72380703|NCT00509392|144269735|SUPERIORITY_OR_OTHER|||||||0.9463||95.0|||||t-test, 2 sided|||||||0.9463
72380704|NCT03954041|144269738|SUPERIORITY||LS mean difference|4.62|||=|0.3752|TWO_SIDED|95.0|-5.74|14.98||P-value was analyzed by ANCOVA model with covariates: treatment, interactive response technology (IRT) stratification factors at randomization, baseline total contusion volume based on central read, imaging modality at Hour 96 (MRI vs NCCT).|ANCOVA|||Statistical analysis of combined BIIB093 vs placebo||14.98|-5.74|= 0.3752
72380705|NCT03954041|144269739|SUPERIORITY||Odds Ratio (OR)|1.16|||||TWO_SIDED|95.0|0.4|3.36||||||Statistical analysis of combined BIIB093 vs placebo||3.36|0.40|
72380706|NCT03954041|144269740|SUPERIORITY||Odds Ratio (OR)|1.47|||=|0.4306|TWO_SIDED|95.0|0.56|3.86||P-value was analyzed by ordinal logistic regression on mRS adjusting for covariates: treatment, IRT stratification factors at randomization, baseline mRS score, and baseline total contusion volume based on central read.|Regression, Logistic|||Statistical analysis of combined BIIB093 vs placebo||3.86|0.56|=0.4306
72380707|NCT03954041|144269742|SUPERIORITY||LS Mean difference|-1.53|||=|0.6478|TWO_SIDED|95.0|-8.19|5.13||P-value was analyzed by ANCOVA model with covariates: treatment, IRT stratification factors at randomization, baseline total contusion volume based on central read.|ANCOVA|||Statistical analysis of combined BIIB093 vs placebo||5.13|-8.19|= 0.6478
72618579|NCT01026038|144768105|SUPERIORITY_OR_OTHER|||||||0.714||95.0|||||Fisher Exact|||Vomiting (Mild): Fisher exact test, 2-sided was used. Pairwise comparison was made between 7vPnC/7vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.||||0.714
72380708|NCT03954041|144269743|SUPERIORITY||LS Mean Difference|-0.09|||=|0.9314|TWO_SIDED|95.0|-2.2|2.02||P-value was analyzed by ANCOVA model with covariates: treatment, IRT stratification factors at randomization, baseline Glasgow Coma Scale (GCS) based on eCRF, and baseline absolute hematoma volume based on central read.|ANCOVA|||Statistical analysis of combined BIIB093 vs placebo||2.02|-2.20|=0.9314
72380709|NCT03954041|144269744|SUPERIORITY||LS Mean difference|2.18|||=|0.6569|TWO_SIDED|95.0|-7.61|11.98||P-value was analyzed by ANCOVA model with covariates: treatment, IRT stratification factors at randomization, baseline absolute edema volume based on central read, baseline GCS based on eCRF, and imaging modality at Hour 96 (MRI vs NCCT).|ANCOVA|||Statistical analysis of combined BIIB093 vs placebo||11.98|-7.61|= 0.6569
72380710|NCT03868124|144269748|NON_INFERIORITY|criteria for statistical and clinical non-inferiority: upper limit of the 95% CI of the difference between the implant group and the timolol group was \< 1.5 mmHg and also \< 1 mmHg for all 6 timepoints for Implant Group 2 vs Timolol|Mean Difference (Final Values)|-1.25|||||TWO_SIDED|95.0|-1.99|-0.5||Fixed sequence hierarchical testing procedure was used, first testing for non-inferiority of Implant Group 2 to timolol at all 6 timepoints before testing non-inferiority of Implant Group 1 to timolol||||"Day 10, 8AM Difference between Implant Group 2 and timolol~Note: Multiple imputation techniques were used to account for missing data such that the sample size at each visit /timepoint was the same for purposes of statistical analyses"||-0.50|-1.99|
72380711|NCT03868124|144269748|NON_INFERIORITY|criteria for statistical and clinical non-inferiority: upper limit of the 95% CI of the difference between the implant group and the timolol group was \< 1.5 mmHg and also \< 1 mmHg for all 6 timepoints for Implant Group 2 vs Timolol|Mean Difference (Final Values)|-1.2|||||TWO_SIDED|95.0|-1.88|-0.52||Fixed sequence hierarchical testing procedure was used, first testing for non-inferiority of Implant Group 2 to timolol at all 6 timepoints before testing non-inferiority of Implant Group 1 to timolol||||"Month 3, 10AM Difference between Implant Group 2 and timolol~Note: Multiple imputation techniques were used to account for missing data such that the sample size at each visit /timepoint was the same for purposes of statistical analyses"||-0.52|-1.88|
72380712|NCT03868124|144269748|NON_INFERIORITY|criteria for statistical and clinical non-inferiority: upper limit of the 95% CI of the difference between the implant group and the timolol group was \< 1.5 mmHg and also \< 1 mmHg for all 6 timepoints for Implant Group 2 vs Timolol|Mean Difference (Final Values)|-0.03|||||TWO_SIDED|95.0|-0.76|0.69||Fixed sequence hierarchical testing procedure was used, first testing for non-inferiority of Implant Group 2 to timolol at all 6 timepoints before testing non-inferiority of Implant Group 1 to timolol||||"Week 6, 8AM Difference between Implant Group 2 and timolol~Note: Multiple imputation techniques were used to account for missing data such that the sample size at each visit /timepoint was the same for purposes of statistical analyses"||0.69|-0.76|
72380713|NCT03868124|144269748|NON_INFERIORITY|criteria for statistical and clinical non-inferiority: upper limit of the 95% CI of the difference between the implant group and the timolol group was \< 1.5 mmHg and also \< 1 mmHg for all 6 timepoints for Implant Group 2 vs Timolol|Mean Difference (Final Values)|0.32|||||TWO_SIDED|95.0|-0.37|1.01||Fixed sequence hierarchical testing procedure was used, first testing for non-inferiority of Implant Group 2 to timolol at all 6 timepoints before testing non-inferiority of Implant Group 1 to timolol||||"Week 6, 10AM Difference between Implant Group 2 and Timolol~Note: Multiple imputation techniques were used to account for missing data such that the sample size at each visit /timepoint was the same for purposes of statistical analyses"||1.01|-0.37|
72504919|NCT01272180|144540895|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The immune response of ABCWY+OMV group was considered to be non-inferior to that of ACWY group if the lower limit of the two-sided 95% confidence interval on the difference between groups in percentage of subjects with seroresponse is greater than -10% for each of A, C, W-135and Y serogroups, at 30 days after the last vaccination.|Group Difference % (ABCWY+OMV - ACWY)|18.0|||||TWO_SIDED|95.0|5.0|31.0||||||Non-inferiority of seroresponse against N.meningitidis serogroup Y of two doses MenABCWY combination vaccine to that of one dose of MenACWY vaccine.||31|5|
72504920|NCT01272180|144540895|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The immune response of MenABCWY+qOMV group was considered to be non-inferior to that of ACWY group if the lower limit of the two-sided 95% confidence interval on the difference between groups in percentage of subjects with seroresponse is greater than -10% for each of A, C, W-135and Y serogroups, at 30 days after the last vaccination.|Group Difference % (ABCWY+qOMV - ACWY)|18.0|||||TWO_SIDED|95.0|7.0|30.0||||||Non-inferiority of seroresponse against N.meningitidis serogroup A of two doses of MenABCWY+qOMV combination vaccine to that of one dose of MenACWY vaccine.||30|7|
72380714|NCT03868124|144269748|NON_INFERIORITY|criteria for statistical and clinical non-inferiority: upper limit of the 95% CI of the difference between the implant group and the timolol group was \< 1.5 mmHg and also \< 1 mmHg for all 6 timepoints for Implant Group 2 vs Timolol|Mean Difference (Final Values)|0.16|||||TWO_SIDED|95.0|-0.59|0.91||Fixed sequence hierarchical testing procedure was used, first testing for non-inferiority of Implant Group 2 to timolol at all 6 timepoints before testing non-inferiority of Implant Group 1 to timolol||||"Month 3, 8AM Difference between Implant Group 2 and timolol~Note: Multiple imputation techniques were used to account for missing data such that the sample size at each visit /timepoint was the same for purposes of statistical analyses"||0.91|-0.59|
72380715|NCT03868124|144269748|NON_INFERIORITY|criteria for statistical and clinical non-inferiority: upper limit of the 95% CI of the difference between the implant group and the timolol group was \< 1.5 mmHg and also \< 1 mmHg for all 6 timepoints for Implant Group 2 vs Timolol|Mean Difference (Final Values)|-0.03|||||TWO_SIDED|95.0|-0.77|0.71||Fixed sequence hierarchical testing procedure was used, first testing for non-inferiority of Implant Group 2 to timolol at all 6 timepoints before testing non-inferiority of Implant Group 1 to timolol||||"Month 3, 10AM Difference between Implant Group 2 and timolol~Note: Multiple imputation techniques were used to account for missing data such that the sample size at each visit /timepoint was the same for purposes of statistical analyses"||0.71|-0.77|
72380716|NCT03868124|144269748|NON_INFERIORITY|criteria for statistical and clinical non-inferiority: upper limit of the 95% CI of the difference between the implant group and the timolol group was \< 1.5 mmHg and also \< 1 mmHg for all 6 timepoints for Implant Group 1 vs. Timolol|Mean Difference (Final Values)|-1.1|||||TWO_SIDED|95.0|-1.84|-0.36||Fixed sequence hierarchical testing procedure was used, first testing for non-inferiority of Implant Group 2 to timolol at all 6 timepoints before testing non-inferiority of Implant Group 1 to timolol||||"Day 10, 8AM Difference between Implant Group 1 vs. Timolol~Note: Multiple imputation techniques were used to account for missing data such that the sample size at each visit /timepoint was the same for purposes of statistical analyses"||-0.36|-1.84|
72380717|NCT03868124|144269748|NON_INFERIORITY|criteria for statistical and clinical non-inferiority: upper limit of the 95% CI of the difference between the implant group and the timolol group was \< 1.5 mmHg and also \< 1 mmHg for all 6 timepoints for Implant Group 1 vs Timolol|Mean Difference (Final Values)|-1.13|||||TWO_SIDED|95.0|-1.81|-0.45||Fixed sequence hierarchical testing procedure was used, first testing for non-inferiority of Implant Group 2 to timolol at all 6 timepoints before testing non-inferiority of Implant Group 1 to timolol||||"Day 10, 10AM Difference between Implant Group 1 vs. Timolol~Note: Multiple imputation techniques were used to account for missing data such that the sample size at each visit /timepoint was the same for purposes of statistical analyses"||-0.45|-1.81|
72380718|NCT03868124|144269748|NON_INFERIORITY|criteria for statistical and clinical non-inferiority: upper limit of the 95% CI of the difference between the implant group and the timolol group was \< 1.5 mmHg and also \< 1 mmHg for all 6 timepoints for Implant Group 1 vs Timolol|Mean Difference (Final Values)|0.33|||||TWO_SIDED|95.0|-0.39|1.06||Fixed sequence hierarchical testing procedure was used, first testing for non-inferiority of Implant Group 2 to timolol at all 6 timepoints before testing non-inferiority of Implant Group 1 to timolol||||"Week 6, 8AM Difference between Implant Group 1 vs. Timolol~Note: Multiple imputation techniques were used to account for missing data such that the sample size at each visit /timepoint was the same for purposes of statistical analyses"||1.06|-0.39|
72380719|NCT03868124|144269748|NON_INFERIORITY|criteria for statistical and clinical non-inferiority: upper limit of the 95% CI of the difference between the implant group and the timolol group was \< 1.5 mmHg and also \< 1 mmHg for all 6 timepoints for Implant Group 1 vs Timolol|Mean Difference (Final Values)|0.23|||||TWO_SIDED|95.0|-0.46|0.93||Fixed sequence hierarchical testing procedure was used, first testing for non-inferiority of Implant Group 2 to timolol at all 6 timepoints before testing non-inferiority of Implant Group 1 to timolol||||"Week 6, 10AM Difference between Implant Group 1 vs. Timolol~Note: Multiple imputation techniques were used to account for missing data such that the sample size at each visit /timepoint was the same for purposes of statistical analyses"||0.93|-0.46|
72380720|NCT03868124|144269748|NON_INFERIORITY|criteria for statistical and clinical non-inferiority: upper limit of the 95% CI of the difference between the implant group and the timolol group was \< 1.5 mmHg and also \< 1 mmHg for all 6 timepoints for Implant Group 1 vs Timolol|Mean Difference (Final Values)|0.53|||||TWO_SIDED|95.0|-0.23|1.28||Fixed sequence hierarchical testing procedure was used, first testing for non-inferiority of Implant Group 2 to timolol at all 6 timepoints before testing non-inferiority of Implant Group 1 to timolol||||"Month 3, 8AM Difference between Implant Group 1 and Timolol~Note: Multiple imputation techniques were used to account for missing data such that the sample size at each visit /timepoint was the same for purposes of statistical analyses"||1.28|-0.23|
72380721|NCT03868124|144269748|NON_INFERIORITY|criteria for statistical and clinical non-inferiority: upper limit of the 95% CI of the difference between the implant group and the timolol group was \< 1.5 mmHg and also \< 1 mmHg for all 6 timepoints for Implant Group 1 vs Timolol|Mean Difference (Final Values)|0.55|||||TWO_SIDED|95.0|-0.19|1.29||Fixed sequence hierarchical testing procedure was used, first testing for non-inferiority of Implant Group 2 to timolol at all 6 timepoints before testing non-inferiority of Implant Group 1 to timolol||||"Month 3, 10AM Difference between Implant Group 1 and Timolol~Note: Multiple imputation techniques were used to account for missing data such that the sample size at each visit /timepoint was the same for purposes of statistical analyses"||1.29|-0.19|
72380722|NCT04902326|144269767|SUPERIORITY|||||||0.78|||||||Regression, Linear|||Compare the mean decrease of HbA1c of the Combo Arm, Financial Incentives arm, and the Tailored Messages arm each with the EUC arm.||||0.78
72380723|NCT04902326|144269768|SUPERIORITY|||||||0.64|||||||Regression, Linear|||Compare the mean decrease of HbA1c of the Combo Arm, Financial Incentives arm, and the Tailored Messages arm each with the EUC arm.||||0.64
72618580|NCT01026038|144768105|SUPERIORITY_OR_OTHER|||||||0.397||95.0|||||Fisher Exact|||Vomiting (Mild): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.||||0.397
72380724|NCT04902326|144269769|SUPERIORITY|||||||0.87|||||||Regression, Linear|||Compare the mean decrease of weight of the Combo Arm, Financial Incentives arm, and the Tailored Messages arm each with the EUC arm.||||0.87
72618581|NCT01026038|144768105|SUPERIORITY_OR_OTHER|||||||0.161||95.0|||||Fisher Exact|||Diarrhea (Any): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/7vPnC/13vPnC.||||0.161
72618582|NCT01026038|144768105|SUPERIORITY_OR_OTHER|||||||0.226||95.0|||||Fisher Exact|||Diarrhea (Any): Fisher exact test, 2-sided was used. Pairwise comparison was made between 7vPnC/7vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.||||0.226
72380725|NCT04902326|144269770|SUPERIORITY|||||||0.87|||||||Regression, Linear|||Compare the mean decrease of weight of the Combo Arm, Financial Incentives arm, and the Tailored Messages arm each with the EUC arm.||||0.87
72380726|NCT04902326|144269771|SUPERIORITY||||||<|0.0001|||||||Regression, Linear|||Compare the mean months engaged (with DPP or metformin) of the Combo Arm, Financial Incentives arm, and the Tailored Messages arm each with the EUC arm.||||<0.0001
72380727|NCT01117051|144269772|SUPERIORITY_OR_OTHER_LEGACY|||||||0.305||95.0|||||Cochran-Mantel-Haenszel|||||||0.305
72380728|NCT03355664|144269815|SUPERIORITY||Hazard Ratio (HR)|0.6||||0.38|TWO_SIDED|95.0|0.2|1.9|||Regression, Cox|||||1.9|0.2|0.38
72380729|NCT01617148|144269850|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
72380730|NCT01617148|144269851|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
72380731|NCT01617148|144269852|SUPERIORITY_OR_OTHER|||||||0.038|||||||t-test, 2 sided|||||||0.038
72380732|NCT01617148|144269853|SUPERIORITY_OR_OTHER|||||||0.038|||||||t-test, 2 sided|||||||0.038
72380733|NCT00423670|144269864|SUPERIORITY_OR_OTHER||Percent difference in SVR|16.7||||0.0126|TWO_SIDED|95.0|3.5|30.0|||Cochran-Mantel Haenszel Chi-square test|Adjusted for baseline stratification factors: black versus non-black, and cirrhosis versus no cirrhosis.||||30|3.5|0.0126
72380734|NCT00423670|144269864|SUPERIORITY_OR_OTHER||Percent difference in SVR|18.8||||0.0048|TWO_SIDED|95.0|5.5|32.2|||Cochran-Mantel Haenszel Chi-square test|Adjusted for baseline stratification factors: black versus non-black, and cirrhosis versus no cirrhosis.||||32.2|5.5|0.0048
72380735|NCT00423670|144269864|SUPERIORITY_OR_OTHER||Percent difference in SVR|29.5|||<|0.0001|TWO_SIDED|95.0|16.5|42.5|||Cochran-Mantel Haenszel Chi-square test|Adjusted for baseline stratification factors: black versus non-black, and cirrhosis versus no cirrhosis.||||42.5|16.5|<0.0001
72380736|NCT00423670|144269864|SUPERIORITY_OR_OTHER||Percent difference in SVR|37.3|||<|0.0001|TWO_SIDED|95.0|24.7|49.8|||Cochran-Mantel Haenszel Chi-square test|Adjusted for baseline stratification factors: black versus non-black, and cirrhosis versus no cirrhosis.||||49.8|24.7|<0.0001
72618583|NCT01026038|144768105|SUPERIORITY_OR_OTHER||||||>|0.99||95.0|||||Fisher Exact|||Diarrhea (Any): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.||||>0.990
72380737|NCT00423670|144269865|SUPERIORITY_OR_OTHER||Percent difference in SVR rates|5.1||||0.2864|TWO_SIDED|95.0|-4.2|14.3|||Cochran-Mantel-Haenszel Chi-Square Test|Adjusted for baseline stratification factors: black versus non black, and cirrhosis versus no cirrhosis.||||14.3|-4.2|0.2864
72380738|NCT00423670|144269866|SUPERIORITY_OR_OTHER||Percent difference in SVR rates|15.6||||0.0009|TWO_SIDED|95.0|6.5|24.8|||Cochran-Mantel-Haenszel Chi-Square Test|Adjusted for the baseline stratification factors: black versus non black, and cirrhosis versus no cirrhosis.||||24.8|6.5|0.0009
72380739|NCT00450112|144269872|SUPERIORITY_OR_OTHER||||||>|0.1||95.0|||||Fisher Exact|||||||>0.1
72380740|NCT00450112|144269873|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||One-sample 2 sided t-test of change from baseline within 2Gel-200 group; no between-group test was performed.||||<0.0001
72380741|NCT00450112|144269873|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||One-sample 2 sided t-test of change from baseline within 1PBS1Gel-200 group; no between-group test was performed.||||<0.0001
72380742|NCT00450112|144269874|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||One-sample 2 sided t-test of change from baseline within 2Gel-200 group; no between-group test was performed.||||<0.0001
72380743|NCT00450112|144269874|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||One-sample 2 sided t-test of change from baseline within 1PBS1Gel-200 group; no between-group test was performed.||||<0.0001
72380744|NCT00450112|144269875|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||One-sample 2 sided t-test of change from baseline within 2Gel-200 group; no between-group test was performed.||||<0.0001
72380745|NCT00450112|144269875|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||One-sample 2 sided t-test of change from baseline within 1PBS1Gel-200 group; no between-group test was performed.||||<0.0001
72380746|NCT00450112|144269876|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||One-sample 2 sided t-test of change from baseline within 2Gel-200 group; no between-group test was performed..||||<0.0001
72380747|NCT00450112|144269876|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||One-sample 2 sided t-test of change from baseline within 1PBS1Gel-200 group; no between-group test was performed.||||<0.0001
72380748|NCT00450112|144269878|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||One-sample 2 sided t-test of change from baseline within 2Gel-200 group; no between-group test was performed.||||<0.0001
72380749|NCT00450112|144269878|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||One-sample 2 sided t-test of change from baseline within 1PBS1Gel-200 group; no between-group test was performed.||||<0.0001
72380750|NCT00450112|144269879|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||One-sample 2 sided t-test of change from baseline within 2Gel-200 group; no between-group test was performed.||||<0.0001
72380751|NCT00450112|144269879|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||One-sample 2 sided t-test of change from baseline within 1PBS1Gel-200 group; no between-group test was performed.||||<0.0001
72380752|NCT01227564|144269996|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.002||||0.9538|TWO_SIDED|95.0|-0.075|0.071||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|||A mixed-effect model repeated measures was used, with the baseline measure of average SUVRs over ROIs and Apo E4 Status (Carrier or Non-carrier) as covariates, time, treatment, and treatment\*time as fixed effects. Estimates of the adjusted mean differences (test-reference) and corresponding 95% confidence intervals were obtained from the model. ACC 3 µg+QS-21 50 µg was the test treatment and placebo was the reference treatment. Statistical analysis presented above for Week 52.||0.071|-0.075|0.9538
72618584|NCT01026038|144768105|SUPERIORITY_OR_OTHER|||||||0.161||95.0|||||Fisher Exact|||Diarrhea (Mild): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/7vPnC/13vPnC.||||0.161
72618585|NCT01026038|144768105|SUPERIORITY_OR_OTHER|||||||0.226||95.0|||||Fisher Exact|||Diarrhea (Mild): Fisher exact test, 2-sided was used. Pairwise comparison was made between 7vPnC/7vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.||||0.226
72618586|NCT01026038|144768105|SUPERIORITY_OR_OTHER||||||>|0.99||95.0|||||Fisher Exact|||Diarrhea (Mild): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.||||>0.990
72380753|NCT01227564|144269996|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.006||||0.8787|TWO_SIDED|95.0|-0.07|0.081||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed-effect model repeated measures was used, with the baseline measure of average SUVRs over ROIs and Apo E4 Status (Carrier or Non-carrier) as covariates, time, treatment, and treatment\*time as fixed effects. Estimates of the adjusted mean differences (test-reference) and corresponding 95% confidence intervals were obtained from the model. ACC 10 µg+QS-21 50 µg was the test treatment and placebo was the reference treatment. Statistical analysis presented above for Week 52.||0.081|-0.070|0.8787
72380754|NCT01227564|144269996|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.002||||0.9544|TWO_SIDED|95.0|-0.062|0.066||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed-effect model repeated measures was used, with the baseline measure of average SUVRs over ROIs and Apo E4 Status (Carrier or Non-carrier) as covariates, time, treatment, and treatment\*time as fixed effects. Estimates of the adjusted mean differences (test-reference) and corresponding 95% confidence intervals were obtained from the model. ACC 3 µg or ACC 10 µg + QS-21 50 µg was the test treatment and placebo was the reference treatment. Statistical analysis presented above for Week 52.||0.066|-0.062|0.9544
72380755|NCT01227564|144269996|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.003||||0.955|TWO_SIDED|95.0|-0.106|0.112||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed-effect model repeated measures was used, with the baseline measure of average SUVRs over ROIs and Apo E4 Status (Carrier or Non-carrier) as covariates, time, treatment, and treatment\*time as fixed effects. Estimates of the adjusted mean differences (test-reference) and corresponding 95% confidence intervals were obtained from the model. ACC 3 µg+QS-21 50 µg was the test treatment and placebo was the reference treatment. Statistical analysis presented above for Week 78.||0.112|-0.106|0.9550
72380756|NCT01227564|144269996|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.008||||0.8874|TWO_SIDED|95.0|-0.121|0.105||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed-effect model repeated measures was used, with the baseline measure of average SUVRs over ROIs and Apo E4 Status (Carrier or Non-carrier) as covariates, time, treatment, and treatment\*time as fixed effects. Estimates of the adjusted mean differences (test-reference) and corresponding 95% confidence intervals were obtained from the model. ACC 10 µg+QS-21 50 µg was the test treatment and placebo was the reference treatment. Statistical analysis presented above for Week 78.||0.105|-0.121|0.8874
72380757|NCT01227564|144269996|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.002||||0.9595|TWO_SIDED|95.0|-0.099|0.095||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed-effect model repeated measures was used, with the baseline measure of average SUVRs over ROIs and Apo E4 Status (Carrier or Non-carrier) as covariates, time, treatment, and treatment\*time as fixed effects. Estimates of the adjusted mean differences (test-reference) and corresponding 95% confidence intervals were obtained from the model. ACC 3 µg or ACC 10 µg + QS-21 50 µg was the test treatment and placebo was the reference treatment. Statistical analysis presented above for Week 78.||0.095|-0.099|0.9595
72380758|NCT01227564|144269996|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.05||||0.3826|TWO_SIDED|95.0|-0.164|0.064||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed-effect model repeated measures was used, with the baseline measure of average SUVRs over ROIs and Apo E4 Status (Carrier or Non-carrier) as covariates, time, treatment, and treatment\*time as fixed effects. Estimates of the adjusted mean differences (test-reference) and corresponding 95% confidence intervals were obtained from the model. ACC 3 µg+QS-21 50 µg was the test treatment and placebo was the reference treatment. Statistical analysis presented above for Week 104.||0.064|-0.164|0.3826
72433631|NCT00991276|144380379|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-7.33|STANDARD_ERROR_OF_MEAN|4.65||0.1175|TWO_SIDED|95.0|-16.54|1.87||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||1.87|-16.54|0.1175
72433632|NCT00991276|144380380|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-23.98|STANDARD_ERROR_OF_MEAN|4.45|<|0.0001|TWO_SIDED|95.0|-32.78|-15.18||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||-15.18|-32.78|<0.0001
72618587|NCT01026038|144768105|SUPERIORITY_OR_OTHER||||||>|0.99||95.0|||||Fisher Exact|||Diarrhea (Moderate): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/7vPnC/13vPnC.||||>0.990
72618588|NCT01026038|144768105|SUPERIORITY_OR_OTHER||||||>|0.99||95.0|||||Fisher Exact|||Diarrhea (Moderate): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.||||>0.990
72380759|NCT01227564|144269996|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.049||||0.3912|TWO_SIDED|95.0|-0.164|0.065||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed-effect model repeated measures was used, with the baseline measure of average SUVRs over ROIs and Apo E4 Status (Carrier or Non-carrier) as covariates, time, treatment, and treatment\*time as fixed effects. Estimates of the adjusted mean differences (test-reference) and corresponding 95% confidence intervals were obtained from the model. ACC 10 µg+QS-21 50 µg was the test treatment and placebo was the reference treatment. Statistical analysis presented above for Week 104.||0.065|-0.164|0.3912
72380760|NCT01227564|144269996|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.05||||0.3221|TWO_SIDED|95.0|-0.149|0.05||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed-effect model repeated measures was used, with the baseline measure of average SUVRs over ROIs and Apo E4 Status (Carrier or Non-carrier) as covariates, time, treatment, and treatment\*time as fixed effects. Estimates of the adjusted mean differences (test-reference) and corresponding 95% confidence intervals were obtained from the model. ACC 3 µg or ACC 10 µg + QS-21 50 µg was the test treatment and placebo was the reference treatment. Statistical analysis presented above for Week 104.||0.050|-0.149|0.3221
72380761|NCT01227564|144269997|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|48.18||||0.9384|TWO_SIDED|95.0|-1197.07|1293.42||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|ANCOVA|||Analysis of Covariance (ANCOVA) was used with baseline assessment and ApoE4 status as covariates, in addition to treatment included in the ANCOVA model.||1293.42|-1197.07|0.9384
72380762|NCT01227564|144269997|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|581.98||||0.3945|TWO_SIDED|95.0|-778.17|1942.13||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|ANCOVA|||ANCOVA was used with baseline assessment and ApoE4 status as covariates, in addition to treatment included in the ANCOVA model.||1942.13|-778.17|0.3945
72380763|NCT01227564|144269997|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|315.08||||0.5773|TWO_SIDED|95.0|-812.15|1442.3||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|ANCOVA|||ANCOVA was used with baseline assessment and ApoE4 status as covariates, in addition to treatment included in the ANCOVA model.||1442.30|-812.15|0.5773
72380764|NCT01227564|144269998|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|24.16||||0.5818|TWO_SIDED|95.0|-63.31|111.62||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|ANCOVA|||ANCOVA was used with baseline assessment and ApoE4 status as covariates, in addition to treatment included in the ANCOVA model.||111.62|-63.31|0.5818
72380765|NCT01227564|144269998|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|84.42||||0.0648|TWO_SIDED|95.0|-5.37|174.21||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|ANCOVA|||ANCOVA was used with baseline assessment and ApoE4 status as covariates, in addition to treatment included in the ANCOVA model.||174.21|-5.37|0.0648
72380766|NCT01227564|144269998|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|54.29||||0.1672|TWO_SIDED|95.0|-23.47|132.05||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|ANCOVA|||ANCOVA was used with baseline assessment and ApoE4 status as covariates, in addition to treatment included in the ANCOVA model.||132.05|-23.47|0.1672
72380767|NCT01227564|144269999|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.36||||0.3106|TWO_SIDED|95.0|-9.94|3.22||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|ANCOVA|||ANCOVA was used with baseline assessment and ApoE4 status as covariates, in addition to treatment included in the ANCOVA model.||3.22|-9.94|0.3106
72380768|NCT01227564|144269999|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.51||||0.1876|TWO_SIDED|95.0|-11.28|2.27||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|ANCOVA|||ANCOVA was used with baseline assessment and ApoE4 status as covariates, in addition to treatment included in the ANCOVA model.||2.27|-11.28|0.1876
72380769|NCT01227564|144269999|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.93||||0.1742|TWO_SIDED|95.0|-9.66|1.79||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|ANCOVA|||ANCOVA was used with baseline assessment and ApoE4 status as covariates, in addition to treatment included in the ANCOVA model.||1.79|-9.66|0.1742
72380770|NCT01227564|144270000|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-30.36||||0.4089|TWO_SIDED|95.0|-103.52|42.81||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|ANCOVA|||ANCOVA was used with baseline assessment and ApoE4 status as covariates, in addition to treatment included in the ANCOVA model.||42.81|-103.52|0.4089
72380771|NCT01227564|144270000|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-83.4||||0.0327|TWO_SIDED|95.0|-159.69|-7.11||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|ANCOVA|||ANCOVA was used with baseline assessment and ApoE4 status as covariates, in addition to treatment included in the ANCOVA model.||-7.11|-159.69|0.0327
72618589|NCT01026038|144768105|SUPERIORITY_OR_OTHER|||||||0.237||95.0|||||Fisher Exact|||Fatigue (Any): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/7vPnC/13vPnC.||||0.237
72618590|NCT01026038|144768105|SUPERIORITY_OR_OTHER|||||||0.045||95.0|||||Fisher Exact|||Fatigue (Any): Fisher exact test, 2-sided was used. Pairwise comparison was made between 7vPnC/7vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.||||0.045
72380772|NCT01227564|144270000|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-56.88||||0.0801|TWO_SIDED|95.0|-120.82|7.06||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|ANCOVA|||ANCOVA was used with baseline assessment and ApoE4 status as covariates, in addition to treatment included in the ANCOVA model.||7.06|-120.82|0.0801
72380773|NCT01227564|144270001|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|19.78||||0.4892|TWO_SIDED|95.0|-37.15|76.71||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 12.||76.71|-37.15|0.4892
72380774|NCT01227564|144270001|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|51.06||||0.0915|TWO_SIDED|95.0|-8.51|110.63||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 12.||110.63|-8.51|0.0915
72380775|NCT01227564|144270001|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|35.42||||0.1638|TWO_SIDED|95.0|-14.88|85.72||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 12.||85.72|-14.88|0.1638
72380776|NCT01227564|144270001|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|99.29||||0.2006|TWO_SIDED|95.0|-54.28|252.86||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 26.||252.86|-54.28|0.2006
72380777|NCT01227564|144270001|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|225.63||||0.0067|TWO_SIDED|95.0|65.18|386.09||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 26.||386.09|65.18|0.0067
72380778|NCT01227564|144270001|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|162.46||||0.0204|TWO_SIDED|95.0|26.05|298.87||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 26.||298.87|26.05|0.0204
72380779|NCT01227564|144270001|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|114.13||||0.0766|TWO_SIDED|95.0|-12.63|240.89||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 52.||240.89|-12.63|0.0766
72380780|NCT01227564|144270001|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|226.82||||0.0181|TWO_SIDED|95.0|40.23|413.41||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 52.||413.41|40.23|0.0181
72618591|NCT01026038|144768105|SUPERIORITY_OR_OTHER|||||||0.285||95.0|||||Fisher Exact|||Fatigue (Any): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.||||0.285
72618592|NCT01026038|144768105|SUPERIORITY_OR_OTHER||||||>|0.99||95.0|||||Fisher Exact|||Fatigue (Mild): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/7vPnC/13vPnC.||||>0.990
72618593|NCT01026038|144768105|SUPERIORITY_OR_OTHER|||||||0.174||95.0|||||Fisher Exact|||Fatigue (Mild): Fisher exact test, 2-sided was used. Pairwise comparison was made between 7vPnC/7vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.||||0.174
72380781|NCT01227564|144270001|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|167.33||||0.0387|TWO_SIDED|95.0|9.03|325.63||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 52.||325.63|9.03|0.0387
72380782|NCT01227564|144270001|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|107.84||||0.2277|TWO_SIDED|95.0|-69.29|284.97||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 78.||284.97|-69.29|0.2277
72380783|NCT01227564|144270001|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|226.82||||0.0181|TWO_SIDED|95.0|40.23|413.41||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 78.||413.41|40.23|0.0181
72380784|NCT01227564|144270001|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|167.33||||0.0387|TWO_SIDED|95.0|9.03|325.63||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 78.||325.63|9.03|0.0387
72380785|NCT01227564|144270001|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|141.92||||0.0747|TWO_SIDED|95.0|-14.62|298.45||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 104.||298.45|-14.62|0.0747
72380786|NCT01227564|144270001|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|204.4||||0.0151|TWO_SIDED|95.0|41.02|367.79||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 104.||367.79|41.02|0.0151
72380787|NCT01227564|144270001|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|173.16||||0.0161|TWO_SIDED|95.0|33.25|313.07||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 104.||313.07|33.25|0.0161
72380788|NCT01227564|144270002|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.652||||0.1807|TWO_SIDED|95.0|-6.57|1.267||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline total brain volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 10.||1.267|-6.570|0.1807
72433633|NCT00991276|144380380|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-24.74|STANDARD_ERROR_OF_MEAN|4.41|<|0.0001|TWO_SIDED|95.0|-33.46|-16.02||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||-16.02|-33.46|<0.0001
72556471|NCT01642277|144644197|SUPERIORITY_OR_OTHER||Standardized test statistic (z-score)|2.06||||0.04|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||For coping score, the non-parametric Mann-Whitney test was used to compare the responder and non-responder groups due to low sample size, non-normal distributions, and outliers of coping scores. The null hypothesis is that there is no difference between the two groups in coping, and the two-sided alternative hypothesis is that one of the two groups has higher (or lower) coping than the other group.||||.04
72618594|NCT01026038|144768105|SUPERIORITY_OR_OTHER|||||||0.125||95.0|||||Fisher Exact|||Fatigue (Mild): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.||||0.125
72380789|NCT01227564|144270002|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.497||||0.8051|TWO_SIDED|95.0|-3.515|4.508||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline total brain volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 10.||4.508|-3.515|0.8051
72380790|NCT01227564|144270002|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.078||||0.5331|TWO_SIDED|95.0|-4.519|2.364||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline total brain volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 10.||2.364|-4.519|0.5331
72380791|NCT01227564|144270002|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.174||||0.9274|TWO_SIDED|95.0|-3.99|3.641||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline total brain volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 24.||3.641|-3.990|0.9274
72380792|NCT01227564|144270002|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.549||||0.0743|TWO_SIDED|95.0|-0.36|7.458||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline total brain volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 24.||7.458|-0.360|0.0743
72380793|NCT01227564|144270002|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.687||||0.3163|TWO_SIDED|95.0|-1.656|5.031||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline total brain volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 24.||5.031|-1.656|0.3163
72380794|NCT01227564|144270002|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.645||||0.519|TWO_SIDED|95.0|-6.721|3.43||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline total brain volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 50.||3.430|-6.721|0.5190
72380795|NCT01227564|144270002|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.758||||0.074|TWO_SIDED|95.0|-0.476|9.991||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline total brain volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 50.||9.991|-0.476|0.0740
72380796|NCT01227564|144270002|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|5.394||||0.4909|TWO_SIDED|95.0|-2.937|6.049||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline total brain volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 50.||6.049|-2.937|0.4909
72380797|NCT01227564|144270002|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.383||||0.9151|TWO_SIDED|95.0|-7.549|6.783||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline total brain volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 76.||6.783|-7.549|0.9151
72556472|NCT01642277|144644197|SUPERIORITY_OR_OTHER||Standardized test statistic (z-score)|2.176||||0.03|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||For the concern score, the non-parametric Mann-Whitney test was used to compare the responder and non-responder groups due to low sample size, non-normal distributions, and outlier of the concern scores. The null hypothesis is that there is no difference between the two groups in their concern, and the two-sided alternative hypothesis is that one of the two groups has higher (or lower) concern than the other group.||||.03
72380798|NCT01227564|144270002|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.394||||0.1533|TWO_SIDED|95.0|-2.069|12.857||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline total brain volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 76.||12.857|-2.069|0.1533
72380799|NCT01227564|144270002|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.506||||0.4371|TWO_SIDED|95.0|-3.904|8.915||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline total brain volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 76.||8.915|-3.904|0.4371
72380800|NCT01227564|144270002|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.21||||0.6167|TWO_SIDED|95.0|-10.999|6.579||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline total brain volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 104.||6.579|-10.999|0.6167
72380801|NCT01227564|144270002|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.11||||0.1844|TWO_SIDED|95.0|-2.993|15.212||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline total brain volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 104.||15.212|-2.993|0.1844
72380802|NCT01227564|144270002|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.95||||0.6205|TWO_SIDED|95.0|-5.888|9.878||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline total brain volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 104.||9.878|-5.888|0.6205
72380803|NCT01227564|144270003|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.418||||0.1695|TWO_SIDED|95.0|-0.183|1.018||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline ventricular volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 10.||1.018|-0.183|0.1695
72380804|NCT01227564|144270003|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.147||||0.6331|TWO_SIDED|95.0|-0.465|0.759||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline ventricular volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 10.||0.759|-0.465|0.6331
72380805|NCT01227564|144270003|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.282||||0.2907|TWO_SIDED|95.0|-0.247|0.812||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline ventricular volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 10.||0.812|-0.247|0.2907
72433634|NCT00991276|144380380|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.76|STANDARD_ERROR_OF_MEAN|4.38||0.8622|TWO_SIDED|95.0|-7.9|9.43||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||9.43|-7.90|0.8622
72618595|NCT01026038|144768105|SUPERIORITY_OR_OTHER|||||||0.058||95.0|||||Fisher Exact|||Fatigue (Moderate): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/7vPnC/13vPnC.||||0.058
72618596|NCT01026038|144768105|SUPERIORITY_OR_OTHER|||||||0.092||95.0|||||Fisher Exact|||Fatigue (Moderate): Fisher exact test, 2-sided was used. Pairwise comparison was made between 7vPnC/7vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.||||0.092
72618597|NCT01026038|144768105|SUPERIORITY_OR_OTHER||||||>|0.99||95.0|||||Fisher Exact|||Fatigue (Moderate): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.||||>0.990
72380806|NCT01227564|144270003|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.007||||0.9846|TWO_SIDED|95.0|-0.675|0.688||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline ventricular volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 24.||0.688|-0.675|0.9846
72380807|NCT01227564|144270003|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.304||||0.3845|TWO_SIDED|95.0|-1.0|0.392||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline ventricular volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 24.||0.392|-1.000|0.3845
72380808|NCT01227564|144270003|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.149||||0.6204|TWO_SIDED|95.0|-0.748|0.45||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline ventricular volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 24.||0.450|-0.748|0.6204
72380809|NCT01227564|144270003|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.014||||0.981|TWO_SIDED|95.0|-1.221|1.192||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline ventricular volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 50.||1.192|-1.221|0.9810
72380810|NCT01227564|144270003|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.796||||0.2034|TWO_SIDED|95.0|-2.034|0.443||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline ventricular volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 50.||0.443|-2.034|0.2034
72380811|NCT01227564|144270003|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.405||||0.4491|TWO_SIDED|95.0|-1.469|0.659||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline ventricular volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 50.||0.659|-1.469|0.4491
72380812|NCT01227564|144270003|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.255||||0.8074|TWO_SIDED|95.0|-1.827|2.337||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline ventricular volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 76.||2.337|-1.827|0.8074
72380813|NCT01227564|144270003|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.029||||0.3444|TWO_SIDED|95.0|-3.189|1.131||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline ventricular volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 76.||1.131|-3.189|0.3444
72433635|NCT00991276|144380381|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-3.3|STANDARD_ERROR_OF_MEAN|1.87||0.08|TWO_SIDED|95.0|-7.0|0.4||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||0.40|-7.00|0.0800
72618598|NCT01026038|144768105|SUPERIORITY_OR_OTHER||||||>|0.99||95.0|||||Fisher Exact|||Fatigue (Severe): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/7vPnC/13vPnC.||||>0.990
72618599|NCT01026038|144768105|SUPERIORITY_OR_OTHER||||||>|0.99||95.0|||||Fisher Exact|||Fatigue (Severe): Fisher exact test, 2-sided was used. Pairwise comparison was made between 7vPnC/7vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.||||>0.990
72618600|NCT01026038|144768105|SUPERIORITY_OR_OTHER||||||>|0.99||95.0|||||Fisher Exact|||Fatigue (Severe): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.||||>0.990
72380814|NCT01227564|144270003|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.387||||0.6772|TWO_SIDED|95.0|-2.239|1.464||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline ventricular volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 76.||1.464|-2.239|0.6772
72380815|NCT01227564|144270003|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.652||||0.6325|TWO_SIDED|95.0|-2.063|3.367||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline ventricular volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 104.||3.367|-2.063|0.6325
72380816|NCT01227564|144270003|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8||||0.5706|TWO_SIDED|95.0|-3.606|2.007||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline ventricular volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 104.||2.007|-3.606|0.5706
72380817|NCT01227564|144270003|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.074||||0.9513|TWO_SIDED|95.0|-2.485|2.337||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline ventricular volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 104.||2.337|-2.485|0.9513
72380818|NCT01227564|144270004|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.015||||0.6054|TWO_SIDED|95.0|-0.074|0.043||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 10.||0.043|-0.074|0.6054
72380819|NCT01227564|144270004|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.025||||0.4087|TWO_SIDED|95.0|-0.035|0.084||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 10.||0.084|-0.035|0.4087
72380820|NCT01227564|144270004|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.005||||0.8518|TWO_SIDED|95.0|-0.046|0.056||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 10.||0.056|-0.046|0.8518
72380821|NCT01227564|144270004|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.025||||0.4216|TWO_SIDED|95.0|-0.085|0.036||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 24.||0.036|-0.085|0.4216
72380822|NCT01227564|144270004|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.034||||0.273|TWO_SIDED|95.0|-0.028|0.097||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 24.||0.097|-0.028|0.2730
72433636|NCT00991276|144380381|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-2.28|STANDARD_ERROR_OF_MEAN|1.86||0.2209|TWO_SIDED|95.0|-5.95|1.39||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||1.39|-5.95|0.2209
72380823|NCT01227564|144270004|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.005||||0.8549|TWO_SIDED|95.0|-0.048|0.058||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 24.||0.058|-0.048|0.8549
72380824|NCT01227564|144270004|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.026||||0.5847|TWO_SIDED|95.0|-0.12|0.068||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 50.||0.068|-0.120|0.5847
72380825|NCT01227564|144270004|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.067||||0.174|TWO_SIDED|95.0|-0.03|0.163||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 50.||0.163|-0.030|0.1740
72380826|NCT01227564|144270004|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.02||||0.6255|TWO_SIDED|95.0|-0.063|0.103||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 50.||0.103|-0.063|0.6255
72380827|NCT01227564|144270004|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.023||||0.7658|TWO_SIDED|95.0|-0.177|0.131||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 76.||0.131|-0.177|0.7658
72380828|NCT01227564|144270004|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.079||||0.3309|TWO_SIDED|95.0|-0.082|0.24||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 76.||0.240|-0.082|0.3309
72380829|NCT01227564|144270004|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.028||||0.6872|TWO_SIDED|95.0|-0.11|0.166||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 76.||0.166|-0.110|0.6872
72380830|NCT01227564|144270004|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.003||||0.9752|TWO_SIDED|95.0|-0.196|0.202||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 104.||0.202|-0.196|0.9752
72433637|NCT00991276|144380381|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.02|STANDARD_ERROR_OF_MEAN|1.84||0.5815|TWO_SIDED|95.0|-4.66|2.63||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||2.63|-4.66|0.5815
72433638|NCT00991276|144380382|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|32.72|STANDARD_ERROR_OF_MEAN|5.41|<|0.0001|TWO_SIDED|95.0|22.02|43.42||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||43.42|22.02|<0.0001
72380831|NCT01227564|144270004|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.143||||0.1715|TWO_SIDED|95.0|-0.064|0.349||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 104.||0.349|-0.064|0.1715
72380832|NCT01227564|144270004|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.073||||0.4145|TWO_SIDED|95.0|-0.105|0.25||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 104.||0.250|-0.105|0.4145
72380833|NCT01227564|144270005|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.011||||0.5134|TWO_SIDED|95.0|-0.043|0.022||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline left hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 10.||0.022|-0.043|0.5134
72380834|NCT01227564|144270005|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.008||||0.6083|TWO_SIDED|95.0|-0.024|0.041||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline left hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 10.||0.041|-0.024|0.6083
72380835|NCT01227564|144270005|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.001||||0.9401|TWO_SIDED|95.0|-0.029|0.027||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline left hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 10.||0.027|-0.029|0.9401
72380836|NCT01227564|144270005|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.018||||0.295|TWO_SIDED|95.0|-0.051|0.016||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline left hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 24.||0.016|-0.051|0.2950
72380837|NCT01227564|144270005|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.003||||0.8817|TWO_SIDED|95.0|-0.031|0.037||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline left hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 24.||0.037|-0.031|0.8817
72380838|NCT01227564|144270005|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.008||||0.6072|TWO_SIDED|95.0|-0.037|0.022||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline left hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 24.||0.022|-0.037|0.6072
72380839|NCT01227564|144270005|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.012||||0.6259|TWO_SIDED|95.0|-0.06|0.036||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline left hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 50.||0.036|-0.060|0.6259
72433639|NCT00991276|144380382|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|25.86|STANDARD_ERROR_OF_MEAN|5.37|<|0.0001|TWO_SIDED|95.0|15.22|36.49||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||36.49|15.22|<0.0001
72556473|NCT01642277|144644197|SUPERIORITY_OR_OTHER||Standardized test statistic (z-score)|0.9||||0.37|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||For the sleep score, the non-parametric Mann-Whitney test was used to compare the responder and non-responder groups due to low sample size, non-normal distributions, and outliers of sleep scores. The null hypothesis is that there is no difference between the two groups in sleep scores, and the two-sided alternative hypothesis is that one of the two groups has higher (or lower) sleep scores than the other group.||||.37
72380840|NCT01227564|144270005|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.027||||0.2807|TWO_SIDED|95.0|-0.023|0.076||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline left hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 50.||0.076|-0.023|0.2807
72380841|NCT01227564|144270005|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.008||||0.7224|TWO_SIDED|95.0|-0.035|0.05||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline left hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 50.||0.050|-0.035|0.7224
72380842|NCT01227564|144270005|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.007||||0.8532|TWO_SIDED|95.0|-0.08|0.067||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline left hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 76.||0.067|-0.080|0.8532
72380843|NCT01227564|144270005|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.039||||0.3116|TWO_SIDED|95.0|-0.038|0.116||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline left hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 76.||0.116|-0.038|0.3116
72380844|NCT01227564|144270005|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.016||||0.6246|TWO_SIDED|95.0|-0.049|0.082||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline left hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 76.||0.082|-0.049|0.6246
72380845|NCT01227564|144270005|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.008||||0.8697|TWO_SIDED|95.0|-0.092|0.108||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline left hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 104.||0.108|-0.092|0.8697
72380846|NCT01227564|144270005|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.072||||0.1707|TWO_SIDED|95.0|-0.032|0.176||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline left hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 104.||0.176|-0.032|0.1707
72380847|NCT01227564|144270005|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.04||||0.3732|TWO_SIDED|95.0|-0.049|0.129||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline left hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 104.||0.129|-0.049|0.3732
72433640|NCT00991276|144380382|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|6.86|STANDARD_ERROR_OF_MEAN|5.33||0.2005|TWO_SIDED|95.0|-3.69|17.42||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||17.42|-3.69|0.2005
72618601|NCT01026038|144768106|SUPERIORITY_OR_OTHER||GMC ratio|0.75|||||TWO_SIDED|95.0|0.56|1.0||||||Serotype 4: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||1.00|0.56|
72380848|NCT01227564|144270006|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.006||||0.7259|TWO_SIDED|95.0|-0.04|0.028||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline right hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 10.||0.028|-0.040|0.7259
72380849|NCT01227564|144270006|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.016||||0.3517|TWO_SIDED|95.0|-0.018|0.051||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline right hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 10.||0.051|-0.018|0.3517
72380850|NCT01227564|144270006|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.005||||0.7311|TWO_SIDED|95.0|-0.024|0.035||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline right hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 10.||0.035|-0.024|0.7311
72380851|NCT01227564|144270006|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.008||||0.6446|TWO_SIDED|95.0|-0.041|0.026||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline right hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 24.||0.026|-0.041|0.6446
72380852|NCT01227564|144270006|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.032||||0.064|TWO_SIDED|95.0|-0.002|0.066||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline right hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 24.||0.066|-0.002|0.0640
72380853|NCT01227564|144270006|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.012||||0.4057|TWO_SIDED|95.0|-0.017|0.041||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline right hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 24.||0.041|-0.017|0.4057
72380854|NCT01227564|144270006|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.015||||0.5742|TWO_SIDED|95.0|-0.066|0.037||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline right hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 50.||0.037|-0.066|0.5742
72433641|NCT00991276|144380383|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|6.8|STANDARD_ERROR_OF_MEAN|1.12|<|0.0001|TWO_SIDED|95.0|4.57|9.02||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||9.02|4.57|<0.0001
72433642|NCT00991276|144380383|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|5.24|STANDARD_ERROR_OF_MEAN|1.12|<|0.0001|TWO_SIDED|95.0|3.02|7.45||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||7.45|3.02|<0.0001
72618602|NCT01026038|144768106|SUPERIORITY_OR_OTHER||GMC Ratio|0.96|||||TWO_SIDED|95.0|0.73|1.28||||||Serotype 4: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.28|0.73|
72380855|NCT01227564|144270006|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.04||||0.1336|TWO_SIDED|95.0|-0.013|0.093||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline right hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 50.||0.093|-0.013|0.1336
72380856|NCT01227564|144270006|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.013||||0.5734|TWO_SIDED|95.0|-0.033|0.058||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline right hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 50.||0.058|-0.033|0.5734
72380857|NCT01227564|144270006|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.016||||0.7067|TWO_SIDED|95.0|-0.104|0.071||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline right hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 76.||0.071|-0.104|0.7067
72380858|NCT01227564|144270006|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.042||||0.36|TWO_SIDED|95.0|-0.049|0.132||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline right hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 76.||0.132|-0.049|0.3600
72380859|NCT01227564|144270006|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.013||||0.7454|TWO_SIDED|95.0|-0.065|0.09||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline right hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 76.||0.090|-0.065|0.7454
72380860|NCT01227564|144270006|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.006||||0.9037|TWO_SIDED|95.0|-0.113|0.1||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline right hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 104.||0.100|-0.113|0.9037
72380861|NCT01227564|144270006|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.07||||0.2082|TWO_SIDED|95.0|-0.04|0.181||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline right hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 104.||0.181|-0.040|0.2082
72380862|NCT01227564|144270006|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.032||||0.5044|TWO_SIDED|95.0|-0.063|0.127||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline right hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 104.||0.127|-0.063|0.5044
72380863|NCT01227564|144270007|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.03||||0.7687|TWO_SIDED|95.0|-0.23|0.17||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 26.||0.17|-0.23|0.7687
72618603|NCT01026038|144768106|SUPERIORITY_OR_OTHER||GMC Ratio|1.29|||||TWO_SIDED|95.0|0.92|1.79||||||Serotype 4: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.79|0.92|
72618604|NCT01026038|144768106|SUPERIORITY_OR_OTHER||GMC ratio|0.7|||||TWO_SIDED|95.0|0.49|1.0||||||Serotype 6B: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||1.00|0.49|
72380864|NCT01227564|144270007|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.04||||0.6804|TWO_SIDED|95.0|-0.16|0.24||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 26.||0.24|-0.16|0.6804
72380865|NCT01227564|144270007|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01||||0.9452|TWO_SIDED|95.0|-0.17|0.18||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 26.||0.18|-0.17|0.9452
72380866|NCT01227564|144270007|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02||||0.8825|TWO_SIDED|95.0|-0.27|0.23||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 52.||0.23|-0.27|0.8825
72380867|NCT01227564|144270007|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02||||0.8791|TWO_SIDED|95.0|-0.28|0.24||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 52.||0.24|-0.28|0.8791
72380868|NCT01227564|144270007|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.02||||0.8628|TWO_SIDED|95.0|-0.24|0.2||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 52.||0.20|-0.24|0.8628
72380869|NCT01227564|144270007|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.04||||0.7843|TWO_SIDED|95.0|-0.35|0.26||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 78.||0.26|-0.35|0.7843
72380870|NCT01227564|144270007|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.28||||0.0857|TWO_SIDED|95.0|-0.04|0.6||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 78.||0.60|-0.04|0.0857
72380871|NCT01227564|144270007|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.12||||0.3878|TWO_SIDED|95.0|-0.15|0.39||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 78.||0.39|-0.15|0.3878
72380872|NCT01227564|144270007|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.03||||0.8918|TWO_SIDED|95.0|-0.39|0.45||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 104.||0.45|-0.39|0.8918
72618605|NCT01026038|144768106|SUPERIORITY_OR_OTHER||GMC ratio|0.89|||||TWO_SIDED|95.0|0.62|1.27||||||Serotype 6B: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.27|0.62|
72618606|NCT01026038|144768106|SUPERIORITY_OR_OTHER||GMC ratio|1.27|||||TWO_SIDED|95.0|0.84|1.94||||||Serotype 6B: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.94|0.84|
72380873|NCT01227564|144270007|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.33||||0.1233|TWO_SIDED|95.0|-0.09|0.76||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 104.||0.76|-0.09|0.1233
72380874|NCT01227564|144270007|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.18||||0.3302|TWO_SIDED|95.0|-0.19|0.55||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 104.||0.55|-0.19|0.3302
72380875|NCT01227564|144270008|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.65||||0.1597|TWO_SIDED|95.0|-0.67|3.97||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 26.||3.97|-0.67|0.1597
72380876|NCT01227564|144270008|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.55||||0.213|TWO_SIDED|95.0|-4.01|0.91||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 26.||0.91|-4.01|0.2130
72380877|NCT01227564|144270008|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.05||||0.9616|TWO_SIDED|95.0|-2.06|2.16||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 26.||2.16|-2.06|0.9616
72380878|NCT01227564|144270008|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.78||||0.2143|TWO_SIDED|95.0|-1.06|4.62||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 52.||4.62|-1.06|0.2143
72380879|NCT01227564|144270008|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.87||||0.2151|TWO_SIDED|95.0|-4.87|1.12||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 52.||1.12|-4.87|0.2151
72380880|NCT01227564|144270008|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.05||||0.9704|TWO_SIDED|95.0|-2.61|2.51||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 52.||2.51|-2.61|0.9704
72380881|NCT01227564|144270008|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.47||||0.7857|TWO_SIDED|95.0|-3.0|3.95||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 78.||3.95|-3.00|0.7857
72618607|NCT01026038|144768106|SUPERIORITY_OR_OTHER||GMC ratio|0.78|||||TWO_SIDED|95.0|0.58|1.03||||||Serotype 9V: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||1.03|0.58|
72618608|NCT01026038|144768106|SUPERIORITY_OR_OTHER||GMC ratio|1.01|||||TWO_SIDED|95.0|0.76|1.33||||||Serotype 9V: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.33|0.76|
72380882|NCT01227564|144270008|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.79||||0.1323|TWO_SIDED|95.0|-6.45|0.87||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 78.||0.87|-6.45|0.1323
72380883|NCT01227564|144270008|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.16||||0.4618|TWO_SIDED|95.0|-4.29|1.97||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 78.||1.97|-4.29|0.4618
72380884|NCT01227564|144270008|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.24||||0.2622|TWO_SIDED|95.0|-1.74|6.22||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 104.||6.22|-1.74|0.2622
72380885|NCT01227564|144270008|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.55||||0.4499|TWO_SIDED|95.0|-5.64|2.55||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 104.||2.55|-5.64|0.4499
72380886|NCT01227564|144270008|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.35||||0.8454|TWO_SIDED|95.0|-3.21|3.91||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 104.||3.91|-3.21|0.8454
72380887|NCT01227564|144270009|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.39||||0.1796|TWO_SIDED|95.0|-0.18|0.96||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 26.||0.96|-0.18|0.1796
72380888|NCT01227564|144270009|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||0.7281|TWO_SIDED|95.0|-0.49|0.69||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 26.||0.69|-0.49|0.7281
72380889|NCT01227564|144270009|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.25||||0.3347|TWO_SIDED|95.0|-0.26|0.75||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 26.||0.75|-0.26|0.3347
72556474|NCT01642277|144644197|SUPERIORITY_OR_OTHER||Standardized test statistic (z-score)|2.02||||0.04|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||For social score, the non-parametric Mann-Whitney test was used to compare the responder and non-responder groups due to low sample size, non-normal distributions, and outliers of social scores. The null hypothesis is that there is no difference between the two groups in social scores, and the two-sided alternative hypothesis is that one of the two groups has higher (or lower) social scores than the other group.||||.04
72556475|NCT01642277|144644197|SUPERIORITY_OR_OTHER||Standardized test statistic (z-score)|2.03||||0.04|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||For the overall health related quality of life (HRQL) score, the non-parametric Mann-Whitney test was used to compare the responder and non-responder groups due to low sample size, non-normal distributions, and outliers of HRQL scores. The null hypothesis is that there is no difference between the two groups in health related quality of life, and the two-sided alternative hypothesis is that one of the two groups has higher (or lower) health realted quality of life than the other group.||||.04
72618609|NCT01026038|144768106|SUPERIORITY_OR_OTHER||GMC ratio|1.29|||||TWO_SIDED|95.0|0.93|1.8||||||Serotype 9V: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.80|0.93|
72380890|NCT01227564|144270009|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.39||||0.3425|TWO_SIDED|95.0|-0.43|1.2||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 52.||1.20|-0.43|0.3425
72380891|NCT01227564|144270009|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.32||||0.4501|TWO_SIDED|95.0|-1.16|0.52||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 52.||0.52|-1.16|0.4501
72380892|NCT01227564|144270009|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.04||||0.9227|TWO_SIDED|95.0|-0.68|0.75||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 52.||0.75|-0.68|0.9227
72380893|NCT01227564|144270009|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.47||||0.345|TWO_SIDED|95.0|-0.51|1.45||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 78.||1.45|-0.51|0.3450
72380894|NCT01227564|144270009|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.56||||0.274|TWO_SIDED|95.0|-1.58|0.45||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 78.||0.45|-1.58|0.2740
72380895|NCT01227564|144270009|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.05||||0.914|TWO_SIDED|95.0|-0.92|0.82||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 78.||0.82|-0.92|0.9140
72380896|NCT01227564|144270009|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.03||||0.0923|TWO_SIDED|95.0|-0.18|2.24||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 104.||2.24|-0.18|0.0923
72380897|NCT01227564|144270009|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.12||||0.8482|TWO_SIDED|95.0|-1.11|1.35||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 104.||1.35|-1.11|0.8482
72380898|NCT01227564|144270009|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.57||||0.284|TWO_SIDED|95.0|-0.49|1.64||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 104.||1.64|-0.49|0.2840
72618610|NCT01026038|144768106|SUPERIORITY_OR_OTHER||GMC ratio|1.04|||||TWO_SIDED|95.0|0.69|1.58||||||Serotype 14: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||1.58|0.69|
72618611|NCT01026038|144768106|SUPERIORITY_OR_OTHER||GMC ratio|1.3|||||TWO_SIDED|95.0|0.86|1.97||||||Serotype 14: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.97|0.86|
72556476|NCT01642277|144644198|SUPERIORITY_OR_OTHER||Standardized test statistic (z-score)|-0.74||||0.46|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||For the obstructive discomfort score, the non-parametric Mann-Whitney test was used to compare the responder and non-responder groups due to low sample size in the non-responder group (n = 13). The null hypothesis is that there is no difference between the two groups in obstructive discomfort, and and the two-sided alternative hypothesis is that one of the two groups has higher (or lower) obstructive discomfort than the other group.||||.46
72556477|NCT01642277|144644198|SUPERIORITY_OR_OTHER||Standardized test statistic (z-score)|-1.8||||0.07|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||For the irritative score, the non-parametric Mann-Whitney test was used to compare the responder and non-responder groups due to low sample size in the non-responder group (n = 13). The null hypothesis is that there is no difference between the two groups in irritation, and the two-sided alternative hypothesis is that one of the two groups has higher (or lower) irritation than the other group.||||.07
72556478|NCT01642277|144644198|SUPERIORITY_OR_OTHER||Standardized test statistic (z-score)|-1.59||||0.11|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||For the stress score, the non-parametric Mann-Whitney test was used to compare the responder and non-responder groups due to low sample size in the non-responder group (n = 13). The null hypothesis is that there is no difference between the two groups in stress, and the two-sided alternative hypothesis is that one of the two groups has higher (or lower) stress than the other group.||||.11
72618612|NCT01026038|144768106|SUPERIORITY_OR_OTHER||GMC ratio|1.25|||||TWO_SIDED|95.0|0.77|2.03||||||Serotype 14: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||2.03|0.77|
72618613|NCT01026038|144768106|SUPERIORITY_OR_OTHER||GMC ratio|0.58|||||TWO_SIDED|95.0|0.42|0.78||||||Serotype 18C: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||0.78|0.42|
72380899|NCT01227564|144270010|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.99||||0.1767|TWO_SIDED|95.0|-4.9|0.92||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 26.||0.92|-4.90|0.1767
72380900|NCT01227564|144270010|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.26||||0.0057|TWO_SIDED|95.0|-7.23|-1.29||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 26.||-1.29|-7.23|0.0057
72380901|NCT01227564|144270010|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.13||||0.0176|TWO_SIDED|95.0|-5.69|-0.57||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 26.||-0.57|-5.69|0.0176
72433643|NCT00991276|144380383|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|1.56|STANDARD_ERROR_OF_MEAN|1.11||0.1622|TWO_SIDED|95.0|-0.64|3.75||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||3.75|-0.64|0.1622
72556479|NCT01642277|144644198|SUPERIORITY_OR_OTHER||Standardized test statistic (z-score)|-1.69||||0.09|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||For the urinary distress inventory score, the non-parametric Mann-Whitney test was used to compare the responder and non-responder groups due to low sample size in the non-responder group (n = 13). The null hypothesis is that there is no difference between the two groups in urinary distress, and the two-sided alternative hypothesis is that one of the two groups has higher (or lower) urinary distress than the other group.||||.09
72556480|NCT01642277|144644198|SUPERIORITY_OR_OTHER||Standardized test statistic (z-score)|-1.68||||0.09|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||For the general score, the non-parametric Mann-Whitney test was used to compare the responder and non-responder groups due to low sample size in the non-responder group (n = 13). The null hypothesis is that there is no difference between the two groups in general pelvic floor disease severity, and the two-sided alternative hypothesis is that one of the two groups has higher (or lower) general pelvic floor disease severity than the other group.||||.09
72556481|NCT01642277|144644198|SUPERIORITY_OR_OTHER||Standardized test statistic (z-score)|-0.23||||0.82|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||For the anterior score, the non-parametric Mann-Whitney test was used to compare the responder and non-responder groups due to low sample size in the non-responder group (n = 13). The null hypothesis is that there is no difference between the two groups in anterior pelvic floor disease severity, and the two-sided alternative hypothesis is that one of the two groups has higher (or lower) anterior pelvic floor disease severity than the other group.||||.82
72556482|NCT01642277|144644198|SUPERIORITY_OR_OTHER||Standardized test statistic (z-score)|-1.92||||0.06|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||For the posterior score, the non-parametric Mann-Whitney test was used to compare the responder and non-responder groups due to low sample size in the non-responder group (n = 13). The null hypothesis is that there is no difference between the two groups in posterior pelvic floor disease severity, and the two-sided alternative hypothesis is that one of the two groups has higher (or lower) posterior pelvic floor disease severity than the other group.||||.06
72380902|NCT01227564|144270010|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.68||||0.679|TWO_SIDED|95.0|-3.98|2.61||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 52.||2.61|-3.98|0.6790
72380903|NCT01227564|144270010|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.21||||0.9028|TWO_SIDED|95.0|-3.62|3.2||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 52.||3.20|-3.62|0.9028
72380904|NCT01227564|144270010|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.45||||0.76|TWO_SIDED|95.0|-3.36|2.47||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 52.||2.47|-3.36|0.7600
72380905|NCT01227564|144270010|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.32||||0.4089|TWO_SIDED|95.0|-4.51|1.86||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 78.||1.86|-4.51|0.4089
72380906|NCT01227564|144270010|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.17||||0.1964|TWO_SIDED|95.0|-5.49|1.15||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 78.||1.15|-5.49|0.1964
72380907|NCT01227564|144270010|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.75||||0.2234|TWO_SIDED|95.0|-4.58|1.09||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 78.||1.09|-4.58|0.2234
72380908|NCT01227564|144270010|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7||||0.6186|TWO_SIDED|95.0|-3.52|2.12||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 104.||2.12|-3.52|0.6186
72380909|NCT01227564|144270010|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.77||||0.5853|TWO_SIDED|95.0|-3.6|2.06||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 104.||2.06|-3.60|0.5853
72380910|NCT01227564|144270010|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.74||||0.5541|TWO_SIDED|95.0|-3.23|1.75||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 104.||1.75|-3.23|0.5541
72433644|NCT00991276|144380390|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.83|STANDARD_ERROR_OF_MEAN|0.18|<|0.0001|TWO_SIDED|95.0|-1.18|-0.47||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||-0.47|-1.18|<0.0001
72380911|NCT01227564|144270011|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.08||||0.937|TWO_SIDED|95.0|-2.09|1.93||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 26.||1.93|-2.09|0.9370
72380912|NCT01227564|144270011|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.16||||0.2597|TWO_SIDED|95.0|-3.19|0.88||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 26.||0.88|-3.19|0.2597
72380913|NCT01227564|144270011|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.62||||0.4852|TWO_SIDED|95.0|-2.38|1.14||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 26.||1.14|-2.38|0.4852
72380914|NCT01227564|144270011|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.73||||0.4542|TWO_SIDED|95.0|-2.69|1.22||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 52.||1.22|-2.69|0.4542
72380915|NCT01227564|144270011|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.03||||0.3061|TWO_SIDED|95.0|-3.04|0.97||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 52.||0.97|-3.04|0.3061
72380916|NCT01227564|144270011|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.88||||0.3082|TWO_SIDED|95.0|-2.61|0.84||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 52.||0.84|-2.61|0.3082
72380917|NCT01227564|144270011|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.11||||0.2672|TWO_SIDED|95.0|-3.09|0.87||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 78.||0.87|-3.09|0.2672
72380918|NCT01227564|144270011|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.11||||0.0427|TWO_SIDED|95.0|-4.15|-0.07||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 78.||-0.07|-4.15|0.0427
72433645|NCT00991276|144380390|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.96|STANDARD_ERROR_OF_MEAN|0.18|<|0.0001|TWO_SIDED|95.0|-1.31|-0.6||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||-0.60|-1.31|<0.0001
72433646|NCT00991276|144380390|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.13|STANDARD_ERROR_OF_MEAN|0.18||0.4677|TWO_SIDED|95.0|-0.22|0.48||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||0.48|-0.22|0.4677
72433647|NCT00991276|144380391|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-25.32|STANDARD_ERROR_OF_MEAN|5.31|<|0.0001|TWO_SIDED|95.0|-35.83|-14.8||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||-14.80|-35.83|<0.0001
72380919|NCT01227564|144270011|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.61||||0.0716|TWO_SIDED|95.0|-3.37|0.15||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 78.||0.15|-3.37|0.0716
72380920|NCT01227564|144270011|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.46||||0.7184|TWO_SIDED|95.0|-2.09|3.0||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 104.||3.00|-2.09|0.7184
72380921|NCT01227564|144270011|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.49||||0.7004|TWO_SIDED|95.0|-2.06|3.03||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 104.||3.03|-2.06|0.7004
72380922|NCT01227564|144270011|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.47||||0.6723|TWO_SIDED|95.0|-1.77|2.71||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 104.||2.71|-1.77|0.6723
72380923|NCT01227564|144270012|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.05||||0.9535|TWO_SIDED|95.0|-1.58|1.68||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 26.||1.68|-1.58|0.9535
72380924|NCT01227564|144270012|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01||||0.9914|TWO_SIDED|95.0|-1.63|1.65||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 26.||1.65|-1.63|0.9914
72380925|NCT01227564|144270012|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.03||||0.9682|TWO_SIDED|95.0|-1.39|1.44||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 26.||1.44|-1.39|0.9682
72380926|NCT01227564|144270012|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.16||||0.2008|TWO_SIDED|95.0|-2.96|0.64||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 52.||0.64|-2.96|0.2008
72380927|NCT01227564|144270012|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.23||||0.7988|TWO_SIDED|95.0|-2.07|1.6||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 52.||1.60|-2.07|0.7988
72380928|NCT01227564|144270012|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.7||||0.3764|TWO_SIDED|95.0|-2.27|0.87||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 52.||0.87|-2.27|0.3764
72380929|NCT01227564|144270012|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.86||||0.4177|TWO_SIDED|95.0|-2.98|1.25||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 78.||1.25|-2.98|0.4177
72380930|NCT01227564|144270012|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5||||0.6494|TWO_SIDED|95.0|-2.67|1.68||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 78.||1.68|-2.67|0.6494
72380931|NCT01227564|144270012|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.68||||0.4674|TWO_SIDED|95.0|-2.54|1.18||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 78.||1.18|-2.54|0.4674
72380932|NCT01227564|144270012|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.02||||0.4709|TWO_SIDED|95.0|-3.85|1.81||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 104.||1.81|-3.85|0.4709
72380933|NCT01227564|144270012|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.19||||0.4128|TWO_SIDED|95.0|-1.7|4.07||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 104.||4.07|-1.70|0.4128
72380934|NCT01227564|144270012|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.08||||0.9478|TWO_SIDED|95.0|-2.41|2.58||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 104.||2.58|-2.41|0.9478
72380935|NCT01227564|144270013|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.53||||0.7146|TWO_SIDED|95.0|-3.4|2.35||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 54.||2.35|-3.40|0.7146
72380936|NCT01227564|144270013|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.64||||0.2733|TWO_SIDED|95.0|-4.6|1.33||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 54.||1.33|-4.60|0.2733
72433648|NCT00991276|144380391|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-28.45|STANDARD_ERROR_OF_MEAN|5.27|<|0.0001|TWO_SIDED|95.0|-38.89|-18.02||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||-18.02|-38.89|<0.0001
72380937|NCT01227564|144270013|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.08||||0.3969|TWO_SIDED|95.0|-3.62|1.46||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 54.||1.46|-3.62|0.3969
72380938|NCT01227564|144270013|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.24||||0.8566|TWO_SIDED|95.0|-2.43|2.92||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 86.||2.92|-2.43|0.8566
72380939|NCT01227564|144270013|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.28||||0.346|TWO_SIDED|95.0|-3.98|1.42||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 86.||1.42|-3.98|0.3460
72380940|NCT01227564|144270013|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.52||||0.6582|TWO_SIDED|95.0|-2.86|1.82||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 86.||1.82|-2.86|0.6582
72380941|NCT01227564|144270015|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.5||||0.7537|TWO_SIDED|95.0|-18.36|13.36||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 26.||13.36|-18.36|0.7537
72380942|NCT01227564|144270015|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.51||||0.1266|TWO_SIDED|95.0|-28.86|3.65||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 26.||3.65|-28.86|0.1266
72380943|NCT01227564|144270015|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.96||||0.6724|TWO_SIDED|95.0|-28.34|18.41||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 52.||18.41|-28.34|0.6724
72380944|NCT01227564|144270015|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-29.7||||0.017|TWO_SIDED|95.0|-53.89|-5.5||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 52.||-5.50|-53.89|0.0170
72504921|NCT01272180|144540895|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The immune response of MenABCWY+qOMV group was considered to be non-inferior to that of MenACWY group if the lower limit of the two-sided 95% confidence interval on the difference between groups in percentage of subjects with seroresponse is greater than -10% for each of A, C, W-135and Y serogroups, at 30 days after the last vaccination.|Group Difference % (ABCWY+qOMV - ACWY)|30.0|||||TWO_SIDED|95.0|18.0|42.0||||||Non-inferiority of seroresponse against N.meningitidis serogroup C of two doses of MenABCWY+qOMV combination vaccine to that of one dose of MenACWY vaccine.||42|18|
72504922|NCT01272180|144540895|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The immune response of MenABCWY+qOMV group was considered to be non-inferior to that of MenACWY group if the lower limit of the two-sided 95% confidence interval on the difference between groups in percentage of subjects with seroresponse is greater than -10% for each of A, C, W-135and Y serogroups, at 30 days after the last vaccination.|Group Difference % (ABCWY+qOMV - ACWY)|19.0|||||TWO_SIDED|95.0|4.0|33.0||||||Non-inferiority of seroresponse against N.meningitidis serogroup W-135 of two doses of MenABCWY+qOMV combination vaccine to that of one dose of MenACWY vaccine.||33|4|
72380945|NCT01227564|144270015|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-30.94||||0.3196|TWO_SIDED|95.0|-92.67|30.78||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 78.||30.78|-92.67|0.3196
72380946|NCT01227564|144270015|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-64.97||||0.049|TWO_SIDED|95.0|-129.64|-0.31||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 78.||-0.31|-129.64|0.0490
72380947|NCT01227564|144270015|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.04||||0.2969|TWO_SIDED|95.0|-14.7|46.79||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 104.||46.79|-14.70|0.2969
72380948|NCT01227564|144270015|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-26.2||||0.0973|TWO_SIDED|95.0|-57.42|5.03||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 104.||5.03|-57.42|0.0973
72380949|NCT01227564|144270016|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.42||||0.6653|TWO_SIDED|95.0|-7.94|5.1||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 26.||5.10|-7.94|0.6653
72380950|NCT01227564|144270016|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.48||||0.4613|TWO_SIDED|95.0|-4.2|9.15||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 26.||9.15|-4.20|0.4613
72380951|NCT01227564|144270016|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.72||||0.771|TWO_SIDED|95.0|-4.18|5.61||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 52.||5.61|-4.18|0.7710
72380952|NCT01227564|144270016|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.02||||0.2328|TWO_SIDED|95.0|-1.99|8.04||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 52.||8.04|-1.99|0.2328
72380953|NCT01227564|144270016|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.8||||0.3693|TWO_SIDED|95.0|-0.97|2.58||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 78.||2.58|-0.97|0.3693
72433649|NCT00991276|144380391|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|3.14|STANDARD_ERROR_OF_MEAN|5.19||0.5461|TWO_SIDED|95.0|-7.13|13.4||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||13.40|-7.13|0.5461
72380954|NCT01227564|144270016|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.74||||0.422|TWO_SIDED|95.0|-1.09|2.56||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 78.||2.56|-1.09|0.4220
72380955|NCT01227564|144270016|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.51||||0.3728|TWO_SIDED|95.0|-24.25|9.23||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 104.||9.23|-24.25|0.3728
72380956|NCT01227564|144270016|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.07||||0.3452|TWO_SIDED|95.0|-25.05|8.91||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 104.||8.91|-25.05|0.3452
72380957|NCT02378025|144270047|SUPERIORITY|||||||0.25|||||||Mixed Models Analysis|||||||.25
72380958|NCT02378025|144270048|SUPERIORITY|||||||0.08|||||||Mixed Models Analysis|||||||.08
72380959|NCT02378025|144270049|SUPERIORITY|||||||0.04|||||||Mixed Models Analysis|||||||.04
72380960|NCT02378025|144270050|SUPERIORITY|||||||0.25|||||||Regression, Logistic|||||||.25
72380961|NCT02378025|144270051|SUPERIORITY|||||||0.22|||||||Regression, Logistic|||||||.22
72380962|NCT02378025|144270052|SUPERIORITY|||||||0.41|||||||Regression, Logistic|||||||.41
72380963|NCT00633867|144270066|SUPERIORITY_OR_OTHER||||||<|0.01||95.0|||||Log Rank|||||||<0.01
72380964|NCT01436162|144270084|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|0.92||0.583|TWO_SIDED|95.0|-2.3|1.3|||Mixed-effects Model for Repeat Measures|||||1.3|-2.3|0.583
72380965|NCT01436162|144270085|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.65||0.354|TWO_SIDED|95.0|-1.9|0.7|||Mixed-effects Model for Repeat Measures|||||0.7|-1.9|0.354
72380966|NCT00859027|144270104|OTHER|||||||0.004|||||||One way ANOVA|||Percent change in femoral neck BMD from baseline||||0.004
72380967|NCT00859027|144270104|OTHER|||||||0.001|||||||One way ANOVA|||Percent change in total hip BMD from baseline||||0.001
72380968|NCT00859027|144270104|OTHER|||||||0.04|||||||One way ANOVA|||Percent change in lumbar spine BMD from baseline||||0.04
72380969|NCT00859027|144270104|OTHER||||||<|0.01|||||||ANOVA|||Between group difference of percent change for the femoral neck BMD||||<0.01
72380970|NCT00859027|144270104|OTHER||||||<|0.01|||||||ANOVA|||Between group difference of percent change for total hip BMD||||<0.01
72380971|NCT00859027|144270105|OTHER|||||||0.015|||||||ANOVA|||Between group difference of percent change for NTX||||0.015
72380972|NCT00859027|144270105|OTHER|||||||0.01|||||||ANOVA|||Between group difference of percent change for CTX||||0.01
72380973|NCT02775903|144270138|SUPERIORITY|||||||0.1838|||||||Wald asymptotic two-sided test|||||||0.1838
72380974|NCT02775903|144270139|SUPERIORITY|||||||0.618|||||||Wald asymptotic two-sided test|||||||0.6180
72380975|NCT02775903|144270140|OTHER|P-values were not part of the formal testing.||||||0.7016|||||||Log Rank|Log-rank test stratified according to the cytogenetic risk at time of randomization (very good, good and intermediate vs poor and very poor)||||||0.7016
72380976|NCT02775903|144270141|OTHER|P-values were not part of the formal testing.||||||0.6076|||||||Log Rank|Log-rank test stratified according to the cytogenetic risk at time of randomization (very good, good and intermediate vs poor and very poor).||||||0.6076
72380977|NCT02775903|144270142|OTHER|P-values were not part of the formal testing.||||||0.384|||||||Wald asymptotic two-sided test|||||||0.3840
72380978|NCT02775903|144270143|OTHER|P-values were not part of the formal testing.||||||0.8961|||||||Log Rank|Log-rank test stratified according to the cytogenetic risk at time of randomization (very good, good and intermediate vs poor and very poor).||||||0.8961
72380979|NCT02775903|144270144|OTHER|P-values were not part of the formal testing.||||||0.3591|||||||Log Rank|Log-rank test stratified according to the cytogenetic risk at time of randomization (very good, good and intermediate vs poor and very poor).||||||0.3591
72380980|NCT02775903|144270145|OTHER|P-values were not part of the formal testing.||||||0.9031|||||||Log Rank|Log-rank test stratified according to the cytogenetic risk at time of randomization (very good, good and intermediate vs poor and very poor).||||||0.9031
72380981|NCT02775903|144270147|OTHER|P-values were not part of the formal testing.||||||0.2409|||||||Log Rank|Log-rank test stratified according to the cytogenetic risk at time of randomization (very intermediate vs poor).||||||0.2409
72380982|NCT02775903|144270148|OTHER|P-values were not part of the formal testing.||||||0.0688|||||||Log Rank|Log-rank test stratified according to the cytogenetic risk at time of randomization (intermediate vs poor).||||||0.0688
72380983|NCT02775903|144270149|OTHER|P-values were not part of the formal testing.||||||0.4894|||||||Wald asymptotic two-sided test|||||||0.4894
72380984|NCT02775903|144270151|OTHER|P-values were not part of the formal testing.||||||0.0381|||||||Log Rank|Log-rank test stratified according to the cytogenetic risk at time of randomization (intermediate vs poor).||||||0.0381
72380985|NCT02775903|144270153|OTHER|P-values were not part of the formal testing.||||||0.8973|||||||Log Rank|Log-rank test stratified according to the cytogenetic risk at time of randomization (very good, good and intermediate vs poor and very poor).||||||0.8973
72380986|NCT02775903|144270153|OTHER|P-values were not part of the formal testing.||||||0.0691|||||||Log Rank|Log-rank test stratified according to the cytogenetic risk at time of randomization (intermediate vs poor).||||||0.0691
72380987|NCT04571515|144270171|SUPERIORITY||Mean Difference (Final Values)|28.3|STANDARD_ERROR_OF_MEAN|9.25||0.003|TWO_SIDED|95.0|9.9|46.6|||Emax|||||46.6|9.9|0.003
72380988|NCT04571515|144270171|SUPERIORITY||Mean Difference (Final Values)|29.6|STANDARD_ERROR_OF_MEAN|7.94|<|0.001|TWO_SIDED|95.0|13.8|45.3|||Emax|||||45.3|13.8|<0.001
72380989|NCT04571515|144270171|SUPERIORITY||Mean Difference (Final Values)|30.3|STANDARD_ERROR_OF_MEAN|8.04|<|0.001|TWO_SIDED|95.0|14.4|46.2|||Emax|||||46.2|14.4|<0.001
72380990|NCT04571515|144270171|SUPERIORITY||Mean Difference (Final Values)|31.1|STANDARD_ERROR_OF_MEAN|8.87|<|0.001|TWO_SIDED|95.0|13.5|48.6|||Emax|||||48.6|13.5|<0.001
72380991|NCT04571515|144270172|OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.62|||TWO_SIDED|95.0|-1.4|1.1||||||||1.1|-1.4|
72380992|NCT04571515|144270172|OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.6|||TWO_SIDED|95.0|-1.5|0.9||||||||0.9|-1.5|
72380993|NCT04571515|144270172|OTHER||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.61|||TWO_SIDED|95.0|-1.8|0.6||||||||0.6|-1.8|
72380994|NCT04571515|144270172|OTHER||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.61|||TWO_SIDED|95.0|-1.1|1.3||||||||1.3|-1.1|
72380995|NCT04571515|144270173|SUPERIORITY||Mean Difference (Final Values)|15.2|STANDARD_ERROR_OF_MEAN|3.99|<|0.001|TWO_SIDED|95.0|7.3|23.1|||Emax|||||23.1|7.3|<0.001
72380996|NCT04571515|144270173|SUPERIORITY||Mean Difference (Final Values)|16.1|STANDARD_ERROR_OF_MEAN|3.43|<|0.001|TWO_SIDED|95.0|9.3|22.9|||Emax|||||22.9|9.3|<0.001
72380997|NCT04571515|144270173|SUPERIORITY||Mean Difference (Final Values)|16.5|STANDARD_ERROR_OF_MEAN|3.47|<|0.001|TWO_SIDED|95.0|9.7|23.4|||Emax|||||23.4|9.7|<0.001
72380998|NCT04571515|144270173|SUPERIORITY||Mean Difference (Final Values)|17.1|STANDARD_ERROR_OF_MEAN|3.84|<|0.001|TWO_SIDED|95.0|9.4|24.7|||Emax|||||24.7|9.4|<0.001
72380999|NCT04571515|144270174|SUPERIORITY|||||||0.208|||||||Log Rank|||Time to Perceptible Pain Relief Subjects are censored at 24 hours if they do not report relief.||||0.208
72381000|NCT04571515|144270174|SUPERIORITY|||||||0.005|||||||Log Rank|||Time to Perceptible Pain Relief Subjects are censored at 24 hours if they do not report relief.||||0.005
72556483|NCT01642277|144644198|SUPERIORITY_OR_OTHER||Standardized test statistic (z-score)|-1.85||||0.07|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||For the pelvic organ prolapse distress score, the non-parametric Mann-Whitney test was used to compare the responder and non-responder groups due to low sample size in the non-responder group (n = 13). The null hypothesis is that there is no difference between the two groups in pelvic organ prolapse distress, and the two-sided alternative hypothesis is that one of the two groups has higher (or lower) pelvic organ prolapse distress than the other group.||||.07
72381001|NCT04571515|144270174|SUPERIORITY|||||||0.192|||||||Log Rank|||Time to Perceptible Pain Relief Subjects are censored at 24 hours if they do not report relief.||||0.192
72381002|NCT04571515|144270174|SUPERIORITY|||||||0.067|||||||Log Rank|||Time to Perceptible Pain Relief Subjects are censored at 24 hours if they do not report relief.||||0.067
72381003|NCT04571515|144270174|SUPERIORITY|||||||0.059|||||||Log Rank|||Time to Meaningful Pain Relief Subjects are censored at 24 hours if they do not report relief.||||0.059
72381004|NCT04571515|144270174|SUPERIORITY||||||<|0.001|||||||Log Rank|||Time to Meaningful Pain Relief Subjects are censored at 24 hours if they do not report relief.||||<0.001
72381005|NCT04571515|144270174|SUPERIORITY|||||||0.017|||||||Log Rank|||Time to Meaningful Pain Relief Subjects are censored at 24 hours if they do not report relief.||||0.017
72381006|NCT04571515|144270174|SUPERIORITY|||||||0.002|||||||Log Rank|||Time to Meaningful Pain Relief Subjects are censored at 24 hours if they do not report relief.||||0.002
72381007|NCT04571515|144270175|SUPERIORITY|||||||0.051|||||||Regression, Logistic|||||||0.051
72381008|NCT04571515|144270175|SUPERIORITY|||||||0.035|||||||Regression, Logistic|||||||0.035
72381009|NCT04571515|144270175|SUPERIORITY|||||||0.016|||||||Regression, Logistic|||||||0.016
72381010|NCT04571515|144270175|SUPERIORITY|||||||0.18|||||||Regression, Logistic|||||||0.180
72381011|NCT04571515|144270176|SUPERIORITY|||||||0.022|||||||Wilcoxon Rank Sum|||||||0.022
72381012|NCT04571515|144270176|SUPERIORITY|||||||0.028|||||||Wilcoxon Rank Sum|||||||0.028
72381013|NCT04571515|144270176|SUPERIORITY|||||||0.007|||||||Wilcoxon Rank Sum|||||||0.007
72381014|NCT04571515|144270176|SUPERIORITY|||||||0.005|||||||Wilcoxon Rank Sum|||||||0.005
72381015|NCT01711372|144270219|OTHER||||||||||||||Chi-squared|||AUC or ROC for Groundskeeper Game|AUC of ROC is 0.78|||
72381016|NCT01711372|144270220|OTHER||||||||||||||||||AUC of ROC. Proportion of accurate ADHD diagnoses is 0.76|||
72381017|NCT01711372|144270221|OTHER|AUC of ROC|||||||||||||||||AUC of ROC. Proportion of accurate ADHD diagnosis is 0.62|||
72381018|NCT03052764|144270227|SUPERIORITY||Least Squares Mean Difference|-2.57|STANDARD_ERROR_OF_MEAN|0.561|<|0.0001|TWO_SIDED|95.0|-3.68|-1.46|||ANCOVA|||||-1.46|-3.68|<.0001
72381019|NCT03052764|144270228|SUPERIORITY||Odds Ratio (OR)|6.15|||||TWO_SIDED|95.0|0.75|50.37|||||Values obtained were from a Cochran Mantel-Haenszel test adjusting for the number of UUI episodes reported at Baseline (\<= 9 versus \> 9 daily episodes)at each scheduled visit.|||50.37|0.75|
72381020|NCT03052764|144270229|SUPERIORITY||Least Squares Mean Difference|-2.24|STANDARD_ERROR_OF_MEAN|0.534|<|0.0001|TWO_SIDED|95.0|-3.3|-1.18|||ANCOVA|||||-1.18|-3.30|<.0001
72381021|NCT03052764|144270230|SUPERIORITY||Least Squares Mean Difference|-2.56|STANDARD_ERROR_OF_MEAN|0.59|<|0.0001|TWO_SIDED|95.0|-3.73|-1.39|||ANCOVA|||||-1.39|-3.73|<.0001
72381022|NCT03052764|144270231|SUPERIORITY||Least Squares Mean Difference|-0.71|STANDARD_ERROR_OF_MEAN|0.192||0.0004|TWO_SIDED|95.0|-1.09|-0.32|||ANCOVA|||||-0.32|-1.09|0.0004
72381023|NCT03052764|144270232|SUPERIORITY||Odds Ratio (OR)|13.03|||||TWO_SIDED|95.0|3.23|52.57|||||Values were obtained from a Cochran Mantel-Haenszel test adjusting for the number of UUI episodes reported at Baseline (\<= 9 versus \> 9 daily episodes) at each scheduled visit.|||52.57|3.23|
72381024|NCT03332771|144270266|NON_INFERIORITY|The non-inferiority hypothesis was declared significant if the upper bound of the 2-sided 95% confidence interval (CI) for the adjusted mean difference is \<0.3.|Difference in Least Squares (LS) Mean|0.12|STANDARD_ERROR_OF_MEAN|0.122||0.3306|TWO_SIDED|95.0|-0.12|0.357|||ANCOVA|||The change from baseline to Week 52 is analyzed using ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of SBP (\<130, ≥130 mmHg) at screening, and country as fixed effects, and baseline HbA1c as a covariate.||0.357|-0.120|0.3306
72381025|NCT03332771|144270266|NON_INFERIORITY|The non-inferiority hypothesis was declared significant if the upper bound of the 2-sided 95% CI for the adjusted mean difference is \<0.3.|Difference in LS Mean|-0.04|STANDARD_ERROR_OF_MEAN|0.114||0.7112|TWO_SIDED|95.0|-0.265|0.181|||ANCOVA|||The change from baseline to Week 52 is analyzed using ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of SBP (\<130, ≥130 mmHg) at screening, and country as fixed effects, and baseline HbA1c as a covariate.||0.181|-0.265|0.7112
72381026|NCT03332771|144270267|SUPERIORITY||Difference in LS Mean|-0.21|STANDARD_ERROR_OF_MEAN|0.119||0.0827|TWO_SIDED|95.0|-0.44|0.027|||ANCOVA|||The change from baseline to Week 26 is analyzed using ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of SBP (\<130, ≥130 mmHg) at screening, and country as fixed effects, and baseline HbA1c as a covariate.||0.027|-0.440|0.0827
72381027|NCT03332771|144270267|SUPERIORITY||Difference in LS Mean|-0.37|STANDARD_ERROR_OF_MEAN|0.103||0.0003|TWO_SIDED|95.0|-0.571|-0.167|||ANCOVA|||The change from baseline to Week 26 is analyzed using ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of SBP (\<130, ≥130 mmHg) at screening, and country as fixed effects, and baseline HbA1c as a covariate.||-0.167|-0.571|0.0003
72381028|NCT03332771|144270268|SUPERIORITY||Difference in LS Mean|-1.49|STANDARD_ERROR_OF_MEAN|0.349|<|0.0001|TWO_SIDED|95.0|-2.173|-0.803|||ANCOVA|||The change from baseline to Week 26 is analyzed using ANCOVA model with treatment groups (placebo, sotagliflozin 200 mg, sotagliflozin 400 mg, glimepiride), randomization strata of HbA1c (≤ 8.5, \>8.5%) at screening, randomization strata of SBP (\<130,≥ 130 mmHg) at screening, and country as fixed effects, and baseline body weight as a covariate.||-0.803|-2.173|<0.0001
72381029|NCT03332771|144270268|SUPERIORITY||Difference in LS Mean|-3.58|STANDARD_ERROR_OF_MEAN|0.544|<|0.0001|TWO_SIDED|95.0|-4.651|-2.517|||ANCOVA|||The change from baseline to Week 52 is analyzed using analysis of ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of SBP (\<130, ≥130 mmHg) at screening, and country as fixed effects and baseline body weight as a covariate.||-2.517|-4.651|< 0.0001
72381030|NCT03332771|144270269|SUPERIORITY||Difference in LS Mean|-4.18|STANDARD_ERROR_OF_MEAN|1.288||0.0012|TWO_SIDED|95.0|-6.701|-1.65|||ANCOVA|||The change from baseline to Week 12 is analyzed using ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, and country as fixed effects, and baseline SBP as a covariate.||-1.650|-6.701|0.0012
72381031|NCT03332771|144270269|SUPERIORITY||Difference in LS Mean|-2.7|STANDARD_ERROR_OF_MEAN|0.0973||0.0973|TWO_SIDED|95.0|-5.89|0.491|||ANCOVA|||The change from baseline to Week 12 is analyzed using ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, and country as fixed effects, and baseline SBP as a covariate.||0.491|-5.890|0.0973
72381032|NCT03332771|144270270|SUPERIORITY||Difference in LS Mean|-4.02|STANDARD_ERROR_OF_MEAN|0.87|<|0.0001|TWO_SIDED|95.0|-5.73|-2.319|||ANCOVA|||The change from baseline to Week 12 is analyzed using ANCOVA model with treatment groups, randomization strata of HbA1c (≤ 8.5, \>8.5%) at screening, and country as fixed effects, and baseline SBP as a covariate.||-2.319|-5.730|<0.0001
72381033|NCT03332771|144270271|SUPERIORITY||Percentage difference|-15.4|||<|0.0001|TWO_SIDED|95.0|-19.67|-11.12|||Cochran-Mantel-Haenszel|||Weighted average of percentage difference between treatment groups from each stratum \[randomization strata of HbA1c \[≤8.5%, \>8.5%\] at screening, randomization strata of mean SBP \[\<130, ≥130 mmHg\] at screening using Cochran-Mantel-Haenszel weights.||-11.12|-19.67|<0.0001
72381034|NCT01557894|144270334|SUPERIORITY_OR_OTHER||||||<|0.01|ONE_SIDED|95.0||||The a priori threshold for statistical significance was set at .05|ANCOVA|Changes in primary outcome measures were evaluated using univariate ANCOVA, with pre-intervention scores as covariates, and group as a fixed factor||||||<0.01
72381035|NCT01557894|144270335|SUPERIORITY_OR_OTHER||||||<|0.01|ONE_SIDED|95.0||||The a priori threshold for statistical significance was set at .05|ANCOVA|Changes in primary outcome measures were evaluated using univariate ANCOVA, with pre-intervention scores as covariates, and group as a fixed factor||||||<0.01
72381036|NCT01557894|144270336|SUPERIORITY_OR_OTHER||||||<|0.01||95.0|||||ANCOVA|Changes in primary outcome measures were evaluated using univariate ANCOVA, with pre-intervention scores as covariates, and group as a fixed factor.||||||<0.01
72381037|NCT01557894|144270337|SUPERIORITY_OR_OTHER||||||<|0.01||95.0|||||ANCOVA|||||||<0.01
72381038|NCT01557894|144270338|SUPERIORITY_OR_OTHER||||||<|0.01||95.0|||||ANCOVA|||||||<0.01
72381039|NCT04123665|144270339|SUPERIORITY||Mean Difference (Net)|-0.07|||<|0.0001|TWO_SIDED|95.0|-0.11|-0.04|||ANCOVA|Analysis of Covariance (ANCOVA) with factors for treatment group and gender, and the baseline whole mouth mean BI and whole mouth MGI as covariates.|Difference is first named treatment (experimental) minus second named treatment (control).|||-0.04|-0.11|<0.0001
72433650|NCT00991276|144380392|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|1.04|STANDARD_ERROR_OF_MEAN|0.21|<|0.0001|TWO_SIDED|95.0|0.63|1.45||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||1.45|0.63|<0.0001
72556484|NCT00908128|144644203|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analyses of Variance (PROC MIXED) was performed on lon-transformed AUCt, AUCinf and Cmax parameters.|Geometric Test/Ref Ratio x 100|90.96||||||90.0|82.4|100.41|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||100.41|82.40|
72381040|NCT02237911|144270348|SUPERIORITY||Mean Difference (Final Values)|-2.1||||0.071|TWO_SIDED|98.3|-4.9|0.7|||Mixed Models Analysis|Contrasts from a linear mixed models analysis at 3 months adjusted for randomization factors (age, gender, BMI, WOMAC-PF, knee flexion).||||0.7|-4.9|0.071
72381041|NCT02237911|144270348|SUPERIORITY||Mean Difference (Final Values)|-2.1||||0.074|TWO_SIDED|98.3|-5.0|0.7|||Mixed Models Analysis|||Contrasts from a linear mixed models analysis at 6 months adjusted by baseline age, gender, BMI, WOMAC-PF, knee flexion.||0.7|-5.0|0.074
72381042|NCT02237911|144270348|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.93|TWO_SIDED|98.3|-2.7|2.9|||Mixed Models Analysis|||Contrasts from a linear mixed models analysis at 3 months adjusted by baseline age, gender, BMI, WOMAC-PF, knee flexion.||2.9|-2.7|0.930
72381043|NCT02237911|144270348|SUPERIORITY||Mean Difference (Final Values)|-0.8||||0.491|TWO_SIDED|98.3|-3.7|2.0|||Mixed Models Analysis|Contrasts from a linear mixed models analysis at 6 months adjusted for randomization factors (age, gender, BMI, WOMAC-PF, knee flexion).||||2.0|-3.7|0.491
72381044|NCT02237911|144270348|SUPERIORITY||Mean Difference (Final Values)|-2.2||||0.021|TWO_SIDED|98.3|-4.5|0.1|||Mixed Models Analysis|Contrasts from a linear mixed models analysis at 3 months adjusted for randomization factors (age, gender, BMI, WOMAC-PF, knee flexion).||||0.1|-4.5|0.021
72381045|NCT02237911|144270348|SUPERIORITY||Mean Difference (Final Values)|-1.3||||0.179|TWO_SIDED|98.3|-3.6|1.0|||Mixed Models Analysis|Contrasts from a linear mixed models analysis at 6 months adjusted for randomization factors (age, gender, BMI, WOMAC-PF, knee flexion).||||1.0|-3.6|0.179
72381046|NCT02237911|144270349|SUPERIORITY||Mean Difference (Final Values)|0.3|||<|0.0001|TWO_SIDED|98.3|0.1|0.4|||Mixed Models Analysis|Contrasts from a linear mixed models analysis at 3 months adjusted for randomization factors (age, gender, BMI, WOMAC-PF, knee flexion).||||0.4|0.1|<0.0001
72381047|NCT02237911|144270349|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.012|TWO_SIDED|98.3|0.01|0.4|||Mixed Models Analysis|Contrasts from a linear mixed models analysis at 6 months adjusted for randomization factors (age, gender, BMI, WOMAC-PF, knee flexion).||||0.4|0.01|0.012
72381048|NCT02237911|144270349|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.005|TWO_SIDED|98.3|0.02|0.3|||Mixed Models Analysis|Contrasts from a linear mixed models analysis at 3 months adjusted for randomization factors (age, gender, BMI, WOMAC-PF, knee flexion).||||0.3|0.02|0.005
72381049|NCT02237911|144270349|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.052|TWO_SIDED|98.3|-0.003|0.3|||Mixed Models Analysis|Contrasts from a linear mixed models analysis at 6 months adjusted for randomization factors (age, gender, BMI, WOMAC-PF, knee flexion).||||0.3|-0.003|0.052
72381050|NCT02237911|144270349|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.015|TWO_SIDED|98.3|0.02|0.3|||Mixed Models Analysis|Contrasts from a linear mixed models analysis at 3 months adjusted for randomization factors (age, gender, BMI, WOMAC-PF, knee flexion).||||0.3|0.02|0.015
72381051|NCT02237911|144270349|SUPERIORITY||Mean Difference (Final Values)|0.02||||0.489|TWO_SIDED|98.3|-0.003|0.3|||Mixed Models Analysis|Contrasts from a linear mixed models analysis at 6 months adjusted for randomization factors (age, gender, BMI, WOMAC-PF, knee flexion).||||0.3|-0.003|0.489
72381052|NCT02237911|144270350|SUPERIORITY||Mean Difference (Final Values)|4.0||||0.943|TWO_SIDED|95.0|-106.0|114.0|||Mixed Models Analysis|Contrasts from a linear mixed models analysis at 3 months adjusted for randomization factors (age, gender, BMI, WOMAC-PF, knee flexion).||||114|-106|0.943
72381053|NCT02237911|144270350|SUPERIORITY||Mean Difference (Final Values)|15.0||||0.814|TWO_SIDED|95.0|-112.0|142.0|||Mixed Models Analysis|Contrasts from a linear mixed models analysis at 6 months adjusted for randomization factors (age, gender, BMI, WOMAC-PF, knee flexion).||||142|-112|0.814
72433651|NCT00991276|144380392|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|1.05|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001|TWO_SIDED|95.0|0.65|1.46||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||1.46|0.65|<0.0001
72556485|NCT00908128|144644204|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analyses of Variance (PROC MIXED) was performed on log-transformed AUCt, AUCinf and Cmax parameters.|Geometric Test/Ref Ratio x 100|99.16||||||90.0|96.24|102.16|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||102.16|96.24|
72381054|NCT02237911|144270350|SUPERIORITY||Mean Difference (Final Values)|-15.0||||0.787|TWO_SIDED|95.0|-125.0|95.0|||Mixed Models Analysis|Contrasts from a linear mixed models analysis at 3 months adjusted for randomization factors (age, gender, BMI, WOMAC-PF, knee flexion).||||95|-125|0.787
72381055|NCT02237911|144270350|SUPERIORITY||Mean Difference (Final Values)|-36.0||||0.581|TWO_SIDED|95.0|-164.0|92.0|||Mixed Models Analysis|Contrasts from a linear mixed models analysis at 6 months adjusted for randomization factors (age, gender, BMI, WOMAC-PF, knee flexion).||||92|-164|0.581
72381056|NCT02237911|144270350|SUPERIORITY||Mean Difference (Final Values)|19.0||||0.676|TWO_SIDED|95.0|-71.0|109.0|||Mixed Models Analysis|Contrasts from a linear mixed models analysis at 3 months adjusted for randomization factors (age, gender, BMI, WOMAC-PF, knee flexion).||||109|-71|0.676
72381057|NCT02237911|144270350|SUPERIORITY||Mean Difference (Final Values)|51.0||||0.33|TWO_SIDED|95.0|-52.0|154.0|||Mixed Models Analysis|Contrasts from a linear mixed models analysis at 6 months adjusted for randomization factors (age, gender, BMI, WOMAC-PF, knee flexion).||||154|-52|0.330
72381058|NCT00958789|144270366|NON_INFERIORITY|"For the primary efficacy hypothesis, H0, the total KSS change from preoperative to 2 years postoperative will be less than or equal to delta. The alternative hypothesis, Ha, will be that the total KSS change from preop to 2 years postoperative is greater than delta. When delta=63, the hypothesis will test for non-inferiority. When delta=70, the hypothesis will test for superiority.~H0: mean 2-year - mean preop less than or equal to delta. Ha: mean 2-year - mean preop greater than delta."|Mean Difference (Final Values)|70.7|||||ONE_SIDED|95.0|64.43||||||||||64.43|
72381059|NCT02131532|144270400|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.25|STANDARD_ERROR_OF_MEAN|3.321||0.03|TWO_SIDED|95.0|1.398|17.102|||t-test, 2 sided|Paired t-test|P values below 0.05 are considered statistically significant in this study.|Null hypothesis: there was no difference in fatigue scores between baseline and three-month assessments||17.102|1.398|0.03
72381060|NCT02131532|144270401|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.625|STANDARD_ERROR_OF_MEAN|1.401||0.1|TWO_SIDED|95.0|-0.687|5.937|||t-test, 2 sided|Paired t-test|P values below 0.05 are considered statistically significant in this study.|Null hypothesis: there was no difference in depression scores between baseline and three-month assessments||5.937|-0.687|0.10
72381061|NCT02131532|144270402|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.25|STANDARD_ERROR_OF_MEAN|0.313||0.45|TWO_SIDED|95.0|-0.991|0.491|||t-test, 2 sided|Paired t-test|P values below 0.05 are considered statistically significant in this study.|Null hypothesis: there was no difference in independence scores between baseline and three-month assessments||0.491|-0.991|0.45
72618614|NCT01026038|144768106|SUPERIORITY_OR_OTHER||GMC ratio|0.91|||||TWO_SIDED|95.0|0.67|1.23||||||Serotype 18C: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.23|0.67|
72381062|NCT02131532|144270403|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.875|STANDARD_ERROR_OF_MEAN|5.03||0.03|TWO_SIDED|95.0|-25.769|-1.981|||t-test, 2 sided|Paired t-test|P values below 0.05 are considered statistically significant in this study.|Null hypothesis: there was no difference in scores of general rating of recovery between baseline and three-month assessments||-1.981|-25.769|0.03
72381063|NCT02131532|144270404|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.781|STANDARD_ERROR_OF_MEAN|5.594||0.89|TWO_SIDED|95.0|-14.01|12.448|||t-test, 2 sided|Paired t-test|P values below 0.05 are considered statistically significant in this study.|Null hypothesis: there was no difference in physical strength scores between baseline and three-month assessments||12.448|-14.010|0.89
72381064|NCT02131532|144270405|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.105|STANDARD_ERROR_OF_MEAN|2.378||0.009|TWO_SIDED|95.0|-7.729|3.519|||t-test, 2 sided|Paired t-test|P values below 0.05 are considered statistically significant in this study.|Null hypothesis: there was no difference in memory and thinking scores between baseline and three-month assessments||3.519|-7.729|0.009
72381065|NCT02131532|144270406|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-18.403|STANDARD_ERROR_OF_MEAN|5.168||0.009|TWO_SIDED|95.0|-30.624|-6.183|||t-test, 2 sided|Paired t-test|P values below 0.05 are considered statistically significant in this study.|Null hypothesis: there was no difference in emotion scores between baseline and three-month assessments||-6.183|-30.624|0.009
72381066|NCT02131532|144270407|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.142|STANDARD_ERROR_OF_MEAN|3.696||0.1|TWO_SIDED|95.0|-15.883|1.598|||t-test, 2 sided|Paired t-test|P values below 0.05 are considered statistically significant in this study.|Null hypothesis: there was no difference in communication scores between baseline and three-month assessments||1.598|-15.883|0.10
72381067|NCT02131532|144270408|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.5|STANDARD_ERROR_OF_MEAN|1.25||0.09|TWO_SIDED|95.0|-5.455|0.455|||t-test, 2 sided|Paired t-test|P values below 0.05 are considered statistically significant in this study.|Null hypothesis: there was no difference in daily activities scores between baseline and three-month assessments||0.455|-5.455|0.09
72381068|NCT02131532|144270409|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.821|STANDARD_ERROR_OF_MEAN|1.382||0.03|TWO_SIDED|95.0|-7.091|-0.551|||t-test, 2 sided|Paired t-test|P values below 0.05 are considered statistically significant in this study.|Null hypothesis: there was no difference in mobility scores between baseline and three-month assessments||-0.551|-7.091|0.03
72381069|NCT02131532|144270410|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.875|STANDARD_ERROR_OF_MEAN|3.264||0.58|TWO_SIDED|95.0|-9.594|5.844||The critical level was adjusted for the multiple comparisons for the eight subscales of the Stroke Impact Scale|t-test, 2 sided|Paired t-test|P values below 0.05 are considered statistically significant in this study.|Null hypothesis: there was no difference in hand function scores between baseline and three-month assessments||5.844|-9.594|0.58
72381070|NCT02131532|144270411|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.576|STANDARD_ERROR_OF_MEAN|3.691||0.006|TWO_SIDED|95.0|-23.304|-5.847||The critical level was adjusted for the multiple comparisons for the eight subscales of the Stroke Impact Scale|t-test, 2 sided|Paired t-test|P values below 0.05 are considered statistically significant in this study.|Null hypothesis: there was no difference in social activity scores between baseline and three-month assessments||-5.847|-23.304|0.006
72381071|NCT00417482|144270419|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.94||||0.02|TWO_SIDED|95.0|1.09|3.45|||Stratified Cox analysis|||The primary hypothesis of a difference in survival functions between the initial Phase B placebo (Arm 3) and risperidone continuation (Arms 1+2) conditions was tested in the primary analysis using the stratified Cox analysis. For descriptive purposes, the overall rate of relapse was assessed as the number of follow-up or for secondary interpretative support, as a simple proportion of patients entering a 16-week period.||3.45|1.09|0.02
72381072|NCT00417482|144270420|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|4.88||||0.02|TWO_SIDED|95.0|1.08|21.98|||stratified cox analyses|||Similar analyses were used to test the secondary hypothesis in the relapse risk in weeks 17 to 32 of Phase B between the patients who continued to receive risperidone (Arm 1) \& the patients who discontinued risperidone at week 16 \& were switched to placebo (Arm 2). Patients who died \& those in whom a relapse was considered to be imminent before they were dropped out in Phase B were classified as having relapse.||21.98|1.08|0.02
72381073|NCT00417482|144270421|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.64|STANDARD_ERROR_OF_MEAN|0.36||0.08|TWO_SIDED|95.0|-0.08|1.35|||t-test, 2 sided|||The null hypothesis is that there is no difference between the risperidone and placebo groups over the 16 week period post randomization, with respect to change in MMSE.||1.35|-0.08|0.08
72618615|NCT01026038|144768106|SUPERIORITY_OR_OTHER||GMC ratio|1.58|||||TWO_SIDED|95.0|1.11|2.25||||||Serotype 18C: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||2.25|1.11|
72381074|NCT00417482|144270422|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.04|STANDARD_ERROR_OF_MEAN|0.49||0.94||95.0|-1.01|0.93|||t-test, 2 sided|||The null hypothesis is that there is no difference between the risperidone and placebo groups over the 16 week period post randomization, with respect to change in TESS.||0.93|-1.01|0.94
72381075|NCT00417482|144270423|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.54|STANDARD_ERROR_OF_MEAN|0.48||0.26|TWO_SIDED|95.0|-1.5|0.41|||t-test, 2 sided|||The null hypothesis is that the difference between placebo and risperidone groups in terms of mean change in EPS, between randomization and week 16, is zero.||0.41|-1.50|0.26
72381076|NCT00417482|144270424|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.22|STANDARD_ERROR_OF_MEAN|0.14||0.13|TWO_SIDED|95.0|-0.5|0.07|||t-test, 2 sided|||The null hypothesis is that the difference between placebo and risperidone groups in terms of mean change in AIMS, between randomization and week 16, is zero.||0.07|-0.50|0.13
72381077|NCT00417482|144270425|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.62|STANDARD_ERROR_OF_MEAN|0.43||0.149|TWO_SIDED|95.0|-1.47|0.23|||t-test, 2 sided|||The null hypothesis is that the difference between placebo and risperidone groups in terms of mean change in PSMS, between randomization and week 16, is zero.||0.23|-1.47|0.149
72381078|NCT00417482|144270426|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.41|STANDARD_ERROR_OF_MEAN|1.69||0.81|TWO_SIDED|95.0|-3.77|2.95|||t-test, 2 sided|||The null hypothesis is that the difference between placebo and risperidone groups in terms of mean change in weight, between randomization and week 16, is zero.||2.95|-3.77|0.81
72381079|NCT05402020|144270427|OTHER||Hazard Ratio (HR)|1.0|||||TWO_SIDED|95.0|0.87|1.15|||||Ratio calculated as \[Tio/Olo\]/\[ICS/LABA\]|Univariate proportional hazards regression was used to compare the time to event (first moderate or severe COPD exacerbations) between the two treatment groups. In the event that there were baseline covariates with unequal distribution between the treatment groups, defined as absolute standardized difference larger than 0.1, the covariate(s) were included in a multiple regression model in addition to the exposure status (Tio/Olo or ICS/LABA).||1.15|0.87|
72381080|NCT05402020|144270428|OTHER||Hazard Ratio (HR)|0.67|||||TWO_SIDED|95.0|0.53|0.85|||||Ratio calculated as \[Tio/Olo\]/\[ICS/LABA\]|Univariate proportional hazards regression was used to compare the time to event (triple therapy escalation) between the two treatment groups. In the event that there were baseline covariates with unequal distribution between the treatment groups, defined as absolute standardized difference larger than 0.1, the covariate(s) were included in a multiple regression model in addition to the exposure status (Tio/Olo or ICS/LABA).||0.85|0.53|
72381081|NCT05402020|144270429|OTHER||Incidence difference|-37.9|||||TWO_SIDED|95.0|-60.1|-15.8|||||Incidence difference calculated as \[incidence rate of Tio/Olo\]-\[incidence rate of ICS/LABA\].|The rate ratio of Tio+Olo - exposed group relative to LABA/ICS group, along with 95% CIs were derived using a univariate negative binomial model. In the event that there are baseline covariates with unequal distribution between the treatment groups, defined as absolute standardized difference larger than 0.1, the covariate(s) will be included in a multiple regression model in addition to the exposure status (Tio/Olo or LABA/ICS).||-15.8|-60.1|
72381082|NCT05402020|144270429|OTHER||Incidence Rate Ratio|0.66|||||TWO_SIDED|95.0|0.51|0.85|||||Ratio calculated as \[incidence rate of Tio/Olo\]/\[incidence rate of ICS/LABA\].|The rate ratio of Tio+Olo - exposed group relative to LABA/ICS group, along with 95% CIs were derived using a univariate negative binomial model. In the event that there are baseline covariates with unequal distribution between the treatment groups, defined as absolute standardized difference larger than 0.1, the covariate(s) will be included in a multiple regression model in addition to the exposure status (Tio/Olo or LABA/ICS).||0.85|0.51|
72381083|NCT05402020|144270430|OTHER||Hazard Ratio (HR)|0.84|||||TWO_SIDED|95.0|0.36|1.93|||||Ratio calculated as \[Tio/Olo\]/\[ICS/LABA\]|Univariate proportional hazards regression was used to compare the time to event (first hospitalization for community-acquired pneumonia after initiation of study drug) between the two treatment groups. In the event that there were baseline covariates with unequal distribution between the treatment groups, defined as absolute standardized difference larger than 0.1, the covariate(s) were included in a multiple regression model in addition to the exposure status (Tio/Olo or ICS/LABA).||1.93|0.36|
72381084|NCT05402020|144270431|OTHER||Annualized rate ratio|0.92|||||TWO_SIDED|95.0|0.81|1.03|||||Annualized rate ratio calculated as \[annualized rate of Tio/Olo\]/\[annualized rate of ICS/LABA\].|The rate ratio of Tio+Olo - exposed group relative to LABA/ICS group, along with 95% CIs were derived using a univariate negative binomial model. In the event that there are baseline covariates with unequal distribution between the treatment groups, defined as absolute standardized difference larger than 0.1, the covariate(s) will be included in a multiple regression model in addition to the exposure status (Tio/Olo or LABA/ICS).||1.03|0.81|
72381085|NCT05402020|144270432|OTHER||Annualized rate ratio|1.01|||||TWO_SIDED|95.0|0.87|1.18|||||Annualized rate ratio calculated as \[annualized rate of Tio/Olo\]/\[annualized rate of ICS/LABA\].|The rate ratio of Tio+Olo - exposed group relative to LABA/ICS group, along with 95% CIs were derived using a univariate negative binomial model. In the event that there are baseline covariates with unequal distribution between the treatment groups, defined as absolute standardized difference larger than 0.1, the covariate(s) will be included in a multiple regression model in addition to the exposure status (Tio/Olo or LABA/ICS).||1.18|0.87|
72381086|NCT06400979|144270433|SUPERIORITY|||||||0.008|||||||ANCOVA|||||||0.008
72381087|NCT06400979|144270434|SUPERIORITY|To assess the reduction of nausea following aromatherapy, pre- and post- aromatherapy scores were compared using paired t-tests||||||0.13|||||||ANCOVA|||||||0.13
72381088|NCT06400979|144270435|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
72381089|NCT06400979|144270436|OTHER|Perceived effectiveness of aromatherapy for patient satisfaction were compared with respect to post-aromatherapy scores and pre-post changes in scores using two-sample t-tests||||||0.02|TWO_SIDED|73.4|||||t-test, 2 sided|||||||0.02
72433652|NCT00991276|144380392|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.2||0.9403|TWO_SIDED|95.0|-0.42|0.39||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||0.39|-0.42|0.9403
72381090|NCT06400979|144270437|SUPERIORITY|||||||0.02|||||||ANCOVA|||||||0.02
72381091|NCT06400979|144270438|SUPERIORITY|||||||0.02|||||||ANCOVA|||||||0.02
72381092|NCT03739840|144270439|SUPERIORITY||Percent reduction|-5.6|||=|0.687|TWO_SIDED|95.0|-38.1|19.2||Adjusted p-values are from the Hochberg step-up procedure within SAS® Proc Multtest to control Type I error.|ANCOVA|||Percent reduction over placebo was calculated as 100\*(1-exp(diff)), where diff was the model estimate of the log ratio between each PSL group and placebo group.||19.2|-38.1|=0.687
72381093|NCT03739840|144270439|SUPERIORITY||Percent reduction|6.5|||=|0.687|TWO_SIDED|95.0|-22.7|28.7||Adjusted p-values were from the Hochberg step-up procedure within SAS® Proc Multtest to control Type I error.|ANCOVA|||Percent reduction over placebo was calculated as 100\*(1-exp(diff)), where diff was the model estimate of the log ratio between each PSL group and placebo group.||28.7|-22.7|=0.687
72381094|NCT03739840|144270439|SUPERIORITY||Percent reduction|6.3|||=|0.687|TWO_SIDED|95.0|-22.9|28.6||Adjusted p-values were from the Hochberg step-up procedure within SAS® Proc Multtest to control Type I error.|ANCOVA|||Percent reduction over placebo was calculated as 100\*(1-exp(diff)), where diff was the model estimate of the log ratio between each PSL group and placebo group.||28.6|-22.9|=0.687
72381095|NCT03739840|144270443|SUPERIORITY||Odds Ratio (OR)|1.15|||=|0.803|TWO_SIDED|95.0|0.39|3.38||Nominal p-values were not adjusted for multiplicity.|Regression, Logistic|||PSL dose/Placebo calculated using logistic regression with categorical factors for treatment group (each PSL dose group referenced to the placebo group), Region (Europe, non-Europe), Baseline SV2A use (Yes, No) and log-transformed Baseline seizure frequency as a continuous covariate.||3.38|0.39|=0.803
72381096|NCT03739840|144270443|SUPERIORITY||Odds Ratio (OR)|0.84|||=|0.772|TWO_SIDED|95.0|0.27|2.65||Nominal p-values were not adjusted for multiplicity.|Regression, Logistic|||PSL dose/Placebo calculated using logistic regression with categorical factors for treatment group (each PSL dose group referenced to the placebo group), Region (Europe, non-Europe), Baseline SV2A use (Yes, No) and log-transformed Baseline seizure frequency as a continuous covariate.||2.65|0.27|=0.772
72381097|NCT03739840|144270443|SUPERIORITY||Odds Ratio (OR)|1.01|||=|0.989|TWO_SIDED|95.0|0.33|3.08||Nominal p-values were not adjusted for multiplicity.|Regression, Logistic|||PSL dose/Placebo calculated using logistic regression with categorical factors for treatment group (each PSL dose group referenced to the placebo group), Region (Europe, non-Europe), Baseline SV2A use (Yes, No) and log-transformed Baseline seizure frequency as a continuous covariate.||3.08|0.33|=0.989
72381098|NCT03739840|144270444|SUPERIORITY||Odds Ratio (OR)|1.4|||=|0.425|TWO_SIDED|95.0|0.61|3.18||Nominal p-values were not adjusted for multiplicity.|Regression, Logistic|||PSL dose/Placebo calculated using logistic regression with categorical factors for treatment group (each PSL dose group referenced to the placebo group), Region (Europe, non-Europe), Baseline SV2A use (Yes, No) and log-transformed Baseline seizure frequency as a continuous covariate.||3.18|0.61|=0.425
72381099|NCT03739840|144270444|SUPERIORITY||Odds Ratio (OR)|1.23|||=|0.625|TWO_SIDED|95.0|0.53|2.85||Nominal p-values were not adjusted for multiplicity.|Regression, Logistic|||PSL dose/Placebo calculated using logistic regression with categorical factors for treatment group (each PSL dose group referenced to the placebo group), Region (Europe, non-Europe), Baseline SV2A use (Yes, No) and log-transformed Baseline seizure frequency as a continuous covariate||2.85|0.53|=0.625
72381100|NCT03739840|144270444|SUPERIORITY||Odds Ratio (OR)|1.9|||=|0.125|TWO_SIDED|95.0|0.84|4.34||Nominal p-values were not adjusted for multiplicity.|Regression, Logistic|||PSL dose/Placebo calculated using logistic regression with categorical factors for treatment group (each PSL dose group referenced to the placebo group), Region (Europe, non-Europe), Baseline SV2A use (Yes, No) and log-transformed Baseline seizure frequency as a continuous covariate||4.34|0.84|=0.125
72381101|NCT03739840|144270445|SUPERIORITY||Median Difference (Final Values)|3.25|||=|0.737|TWO_SIDED|95.0|-17.08|20.36||Nominal p-values were not adjusted for multiplicity.|Wilcoxon (Mann-Whitney)|||Dose group comparisons to Placebo p-value are based on the Wilcoxon-Mann-Whitney test. Hodges Lehmann nonparametric effect estimates and corresponding two-sided 95% asymptotic confidence intervals are provided for the effect difference between each PSL dose and placebo.||20.36|-17.08|=0.737
72381102|NCT03739840|144270445|SUPERIORITY||Median Difference (Net)|6.17|||=|0.458|TWO_SIDED|95.0|-10.0|21.91||Nominal p-values were not adjusted for multiplicity.|Wilcoxon (Mann-Whitney)|||Dose group comparisons to Placebo p-value are based on the Wilcoxon-Mann-Whitney test. Hodges Lehmann nonparametric effect estimates and corresponding two-sided 95% asymptotic confidence intervals are provided for the effect difference between each PSL dose and placebo.||21.91|-10.00|=0.458
72381103|NCT03739840|144270445|SUPERIORITY||Median Difference (Net)|9.31|||=|0.341|TWO_SIDED|95.0|-10.92|28.21||Nominal p-values were not adjusted for multiplicity.|Wilcoxon (Mann-Whitney)|||Dose group comparisons to Placebo p-value are based on the Wilcoxon-Mann-Whitney test. Hodges Lehmann nonparametric effect estimates and corresponding two-sided 95% asymptotic confidence intervals are provided for the effect difference between each PSL dose and placebo.||28.21|-10.92|=0.341
72381104|NCT01058265|144270447|SUPERIORITY_OR_OTHER|||||||0.487||95.0|||||Wilcoxon (Mann-Whitney)|||The null hypothesis is that there is no difference in PCS between two groups.||||0.487
72381105|NCT01058265|144270448|SUPERIORITY_OR_OTHER|||||||0.817||95.0|||||Wilcoxon (Mann-Whitney)|||The null hypothesis is that there is no difference in MCS between two groups.||||0.817
72381106|NCT02343081|144270449|NON_INFERIORITY_OR_EQUIVALENCE|Assuming an intrasubject CV of 15%, an enrollment of 16 subjects was selected to provide a minimum of 80% power for the 90% CI of the ratio of the mean for Cmax for Temozolomide reference and test to fall within the 80-125% confidence range.|Cmax|94.37|||<|0.05|TWO_SIDED|90.0|82.69|107.69|||ANOVA|Primary parameters were analyzed using ANOVA. A linear, mixed model for crossover designs (two-period, two-sequence, two-treatment) was used.|Cmax Test/Reference Ratio|Bioequivalence assessment was made for the 90% CI for the ratio of log transformed pharmacokinetic parameters μT / μR and with the two one-sided Schuirmann T-test procedure under the null hypothesis||107.69|82.69|<0.05
72381107|NCT02343081|144270453|NON_INFERIORITY_OR_EQUIVALENCE|Assuming an intrasubject CV of 15%, an enrollment of 16 subjects was selected to provide a minimum of 80% power for the 90% CI of the means ratio for AUC0-t for Temozolomide reference and test to fall within the 80-125% confidence range.|AUC0-t|100.99|||<|0.05|TWO_SIDED|90.0|97.81|104.28|||ANOVA||AUC0-t Test/Reference Ratio|||104.28|97.81|<0.05
72381108|NCT02343081|144270454|NON_INFERIORITY_OR_EQUIVALENCE|Assuming an intrasubject CV of 15%, an enrollment of 16 subjects was selected to provide a minimum of 80% power for the 90% CI of the means ratio for AUC0-inf for Temozolomide reference and test to fall within the 80-125% confidence range.|AUC0-inf|101.53|||<|0.05|TWO_SIDED|90.0|98.6|104.54|||ANOVA||AUC0-inf Test/Reference Ratio|||104.54|98.60|<0.05
72381109|NCT02169284|144270455|OTHER|||||||0.208|||||||Wilcoxon rank-sum test|||Nucleus P-EGFR in benign tissue between erlotinib and placebo||||0.208
72381110|NCT02169284|144270455|OTHER|||||||0.208|||||||Wilcoxon rank-sum test|||Cytoplasm P-EGFR in benign tissue between erlotinib and placebo||||0.208
72381111|NCT02169284|144270455|OTHER|||||||0.272|||||||Wilcoxon rank-sum test|||Membrane P-EGFR in benign tissue between erlotinib and placebo||||0.272
72381112|NCT02169284|144270455|OTHER|||||||0.22|||||||Wilcoxon rank-sum test|||Entire Cell P-EGFR in benign tissue between erlotinib and placebo||||0.220
72381113|NCT02169284|144270456|OTHER|||||||0.361|||||||Wilcoxon rank-sum test|||Nucleus P-EGFR in Tumor Tissue, p-value between placebo and Erlotinib||||0.361
72381114|NCT02169284|144270456|OTHER|||||||0.383|||||||Wilcoxon rank-sum test|||Cytoplasm P-EGFR in Tumor Tissue, p-value between placebo and Erlotinib||||0.383
72381115|NCT02169284|144270456|OTHER|||||||0.427|||||||Wilcoxon rank-sum test|||Membrane P-EGFR in Tumor Tissue, p-value between placebo and Erlotinib||||0.427
72381116|NCT02169284|144270456|OTHER|||||||0.416|||||||Wilcoxon rank-sum test|||Entire Cell P-EGFR in Tumor Tissue, p-value between placebo and Erlotinib||||0.416
72381117|NCT02169284|144270457|OTHER|||||||1|||||||Wilcoxon rank-sum test|||Baseline visit - p-value between erlotinib and placebo arms||||1.000
72381118|NCT02169284|144270457|OTHER|||||||0.199|||||||Wilcoxon rank-sum test|||Day 8 - p-value between erlotinib and placebo arms||||0.199
72381119|NCT02169284|144270457|OTHER||||||<|0.001|||||||Wilcoxon rank-sum test|||Surgery visit - p-value between erlotinib and placebo arms||||<0.001
72504923|NCT01272180|144540895|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The immune response of MenABCWY+qOMV group was considered to be non-inferior to that of MenACWY group if the lower limit of the two-sided 95% confidence interval on the difference between groups in percentage of subjects with seroresponse is greater than -10% for each of A, C, W-135and Y serogroups, at 30 days.|Group Difference % (ABCWY+qOMV - ACWY)|15.0|||||TWO_SIDED|95.0|3.0|29.0||||||Non-inferiority of seroresponse against N.meningitidis serogroup Y of two doses of MenABCWY+qOMV combination vaccine to that of one dose of MenACWY vaccine.||29|3|
72381120|NCT02169284|144270458|OTHER|||||||1|||||||Wilcoxon rank-sum test|||Baseline visit - p-value between erlotinib and placebo arms||||1.000
72381121|NCT02169284|144270458|OTHER|||||||0.288|||||||Wilcoxon rank-sum test|||Day 8 - p-value between erlotinib and placebo arms||||0.288
72381122|NCT02169284|144270458|OTHER||||||<|0.001|||||||Wilcoxon rank-sum test|||Surgery visit - p-value between erlotinib and placebo arms||||<0.001
72381123|NCT02169284|144270459|OTHER|||||||0.792|||||||Wilcoxon rank-sum test|||P-value between groups at Baseline||||0.792
72381124|NCT02169284|144270459|OTHER|||||||0.261|||||||Wilcoxon rank-sum test|||P-value between groups at surgery visit||||0.261
72381125|NCT02169284|144270460|OTHER|||||||0.721|||||||Wilcoxon rank-sum test|||Expression of e-cadherin in Benign Tissue, P-Value between arms||||0.721
72381126|NCT02169284|144270460|OTHER|||||||0.108|||||||Wilcoxon rank-sum test|||Expression of e-cadherin in Tumor Tissue, P-Value between arms||||0.108
72381127|NCT02169284|144270461|OTHER|||||||0.444|||||||Wilcoxon rank-sum test|||Expression of KI-67 in Benign Tissue, P-Value between arms||||0.444
72381128|NCT02169284|144270461|OTHER|||||||0.663|||||||Wilcoxon rank-sum test|||Expression of KI-67 in Tumor Tissue, P-Value between arms||||0.663
72381129|NCT02169284|144270462|OTHER|||||||1|||||||Wilcoxon rank-sum test|||Difference in p-ERK between Normal and Tumor Tissue, P-Value between arms||||1.000
72381130|NCT02169284|144270462|OTHER|||||||0.792|||||||Wilcoxon rank-sum test|||Difference in Cytoplasm p-ERK between Normal and Tumor Tissue, P-Value between arms||||0.792
72381131|NCT02169284|144270462|OTHER|||||||1|||||||Wilcoxon rank-sum test|||Difference in Entire Cell p-ERK between Normal and Tumor Tissue, p-value between arms||||1.000
72381132|NCT02169284|144270463|OTHER|||||||0.772|||||||Wilcoxon rank-sum test|||||||0.772
72381133|NCT03583073|144270467|SUPERIORITY|||||||0.053|||||||Chi-squared, Corrected|DF = 1||||||.053
72381134|NCT03583073|144270468|SUPERIORITY||Mean Difference (Final Values)|1.94||||0.072|TWO_SIDED|95.0|-0.18|4.06|||Chi-squared, Corrected|||||4.06|-0.18|.072
72381135|NCT01367119|144270469|SUPERIORITY_OR_OTHER|||||||0.171||95.0|||||t-test, 2 sided|||P-values take into account variability across treatments and within subject.||||0.171
72381136|NCT01367119|144270470|SUPERIORITY_OR_OTHER|||||||0.258||95.0|||||t-test, 2 sided|||P-values take into account variability across treatments and within subject.||||0.258
72381137|NCT01367119|144270471|SUPERIORITY_OR_OTHER|||||||0.091||95.0|||||t-test, 2 sided|||Comparison between groups for nausea||||0.091
72381138|NCT01367119|144270471|SUPERIORITY_OR_OTHER|||||||0.763||95.0|||||t-test, 2 sided|||Comparison between groups for headache||||0.763
72556486|NCT00908128|144644205|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analyses of Variance (PROC MIXED) was performed on the log-transformed AUCt, AUCinf and Cmax parameters.|Geometric Test/Ref Ratio x 100|98.78||||||90.0|95.76|101.89|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||101.89|95.76|
72381139|NCT01367119|144270471|SUPERIORITY_OR_OTHER|||||||0.356||95.0|||||t-test, 2 sided|||Comparison between groups for myalgia||||0.356
72381140|NCT01367119|144270471|SUPERIORITY_OR_OTHER|||||||0.093||95.0|||||t-test, 2 sided|||Comparison between groups for visual disturbance||||0.093
72381141|NCT01367119|144270471|SUPERIORITY_OR_OTHER|||||||0.003||95.0|||||t-test, 2 sided|||Comparison between groups for confusion||||0.003
72381142|NCT01367119|144270471|SUPERIORITY_OR_OTHER|||||||0.86||95.0|||||t-test, 2 sided|||Comparison between groups for recovery room agitation||||0.860
72381143|NCT03180684|144270472|SUPERIORITY|||||||0.0071|||||||Clopper Pearson|A 1-sided p-value was calculated to prove superiority over historical control of 2%. Superiority of VGX-3100 alone was declared if p-value is \<0.025.||||||0.0071
72381144|NCT03180684|144270472|SUPERIORITY|||||||0.0004|||||||Clopper Pearson|1-sided p-value was calculated to prove superiority over historical control of 2%.Superiority of VGX-3100+imiquimod was declared if p-value is \<0.025.||||||0.0004
72381145|NCT02675231|144270484|SUPERIORITY|The abemaciclib plus trastuzumab plus fulvestrant arm will be compared to the standard of care (SOC) chemotherapy plus trastuzumab arm first, and the abemaciclib doublet arm will be compared to the SOC chemotherapy plus trastuzumab arm only if the test for the triplet vs the SOC chemotherapy plus trastuzumab arm is significant.||||||0.0506|||||||Log Rank|Stratified by number of prior systemic regimens for advanced breast cancer (2 to 3 versus(vs) \>3) and status of disease(measurable vs non-measurable).||PFS analysis was planned after approximately 165 PFS events occurred in the enrolled population, yielding greater than or equal to (≥) 80% power assuming a Hazard ration (HR) of 0·667 at an experiment-wise 2-sided alpha level of 0·2.||||0.0506
72381146|NCT02675231|144270484|SUPERIORITY|The abemaciclib plus trastuzumab plus fulvestrant arm will be compared to the standard of care (SOC) chemotherapy plus trastuzumab arm first, and the abemaciclib doublet arm will be compared to the SOC chemotherapy plus trastuzumab arm only if the test for the triplet vs the SOC chemotherapy plus trastuzumab arm is significant.||||||0.7695|||||||Log Rank|Stratified by number of prior systemic regimens for advanced breast cancer (2 to 3 versus(vs) \>3) and status of disease(measurable vs non-measurable).||PFS analysis was planned after approximately 165 PFS events occurred in the enrolled population, yielding greater than or equal to (≥) 80% power assuming a Hazard ration (HR) of 0·667 at an experiment-wise 2-sided alpha level of 0·2.||||0.7695
72381147|NCT02675231|144270485|SUPERIORITY||Hazard Ratio (HR)|0.68||||0.241|TWO_SIDED|95.0|0.36|1.3|||Log Rank||Stratified by the number of previous regimens (excluding single-agent endocrine therapy) for advanced breast cancer and the status of disease (measurable vs. non-measurable).|||1.30|0.36|0.241
72381148|NCT02675231|144270485|SUPERIORITY||Hazard Ratio (HR)|0.72||||0.313|TWO_SIDED|95.0|0.38|1.36|||Log Rank||Stratified by the number of previous regimens (excluding single-agent endocrine therapy) for advanced breast cancer and the status of disease (measurable vs. non-measurable).|||1.36|0.38|0.313
72381149|NCT02675231|144270486|SUPERIORITY||Hazard Ratio (HR)|0.67||||0.104|TWO_SIDED|95.0|0.42|1.08|||Log Rank||Stratified by the number of previous regimens (excluding single-agent endocrine therapy) for advanced breast cancer and the status of disease (measurable vs. non-measurable).|||1.08|0.42|0.104
72381150|NCT02675231|144270486|SUPERIORITY||Hazard Ratio (HR)|0.69||||0.12|TWO_SIDED|95.0|0.43|1.1|||Log Rank||Stratified by the number of previous regimens (excluding single-agent endocrine therapy) for advanced breast cancer and the status of disease (measurable vs. non-measurable).|||1.10|0.43|0.120
72381151|NCT02675231|144270487|SUPERIORITY||Hazard Ratio (HR)|0.65||||0.049|TWO_SIDED|95.0|0.42|1.0|||Log Rank||Stratified by the number of previous regimens (excluding single-agent endocrine therapy) for advanced breast cancer and the status of disease (measurable vs. non-measurable).|||1.00|0.42|0.049
72381152|NCT02675231|144270487|SUPERIORITY||Hazard Ratio (HR)|0.74||||0.153|TWO_SIDED|95.0|0.48|1.12|||Log Rank||Stratified by the number of previous regimens (excluding single-agent endocrine therapy) for advanced breast cancer and the status of disease (measurable vs. non-measurable).|||1.12|0.48|0.153
72381153|NCT02675231|144270492|SUPERIORITY||Mean Difference (Final Values)|-0.31||||0.232|TWO_SIDED|||||p-values are from Type 3 sums of squares mixed models repeated measures model (MMRM): Change from baseline = Treatment + Visit + Treatment\*Visit + Baseline.|MMRM Model|||||||0.232
72381154|NCT02675231|144270493|SUPERIORITY||Least Square (LS) Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|2.4||0.689|TWO_SIDED|||||p-values are from Type 3 sums of squares mixed models repeated measures model (MMRM): Change from baseline = Treatment + Visit + Treatment\*Visit + Baseline.|MMRM Model|||Global health status||||0.689
72381155|NCT02675231|144270493|SUPERIORITY||LS Mean Difference|3.4|STANDARD_ERROR_OF_MEAN|2.3||0.141|TWO_SIDED|||||p-values are from Type 3 sums of squares mixed models repeated measures model (MMRM): Change from baseline = Treatment + Visit + Treatment\*Visit + Baseline.|MMRM Model|||Functional scales: Physical functioning||||0.141
72381156|NCT02675231|144270493|SUPERIORITY||LS Mean Difference|5.5|STANDARD_ERROR_OF_MEAN|3.3||0.095|TWO_SIDED|||||p-values are from Type 3 sums of squares mixed models repeated measures model (MMRM): Change from baseline = Treatment + Visit + Treatment\*Visit + Baseline.|MMRM Model|||Functional scale: Role functioning||||0.095
72381157|NCT02675231|144270493|SUPERIORITY||LS Mean Difference|1.3|STANDARD_ERROR_OF_MEAN|2.5||0.591|TWO_SIDED|||||p-values are from Type 3 sums of squares mixed models repeated measures model (MMRM): Change from baseline = Treatment + Visit + Treatment\*Visit + Baseline.|MMRM Model|||Functional scale: Emotional functioning||||0.591
72381158|NCT02675231|144270493|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|2.1||0.935|TWO_SIDED|||||p-values are from Type 3 sums of squares mixed models repeated measures model (MMRM): Change from baseline = Treatment + Visit + Treatment\*Visit + Baseline.|MMRM Model|||Functional scale: Cognitive functioning||||0.935
72556487|NCT02842853|144644207|EQUIVALENCE|Lot consistency was demonstrated across the 3 lots, if, for each pair of lots and each antigen, the 2-sided 95% Confidence Interval (CI) for the ratio of the GMTs lies between 1/2 and 2.|GMT Ratio|0.88|||||TWO_SIDED|95.0|0.751|1.03||||||Serogroup A: Lot 1 vs Lot 2||1.03|0.751|
72556488|NCT02842853|144644207|EQUIVALENCE|Lot consistency was demonstrated across the 3 lots, if, for each pair of lots and each antigen, the 2-sided 95% CI for the ratio of the GMTs lies between 1/2 and 2.|GMT Ratio|0.985|||||TWO_SIDED|95.0|0.843|1.15||||||Serogroup A: Lot 2 vs Lot 3||1.15|0.843|
72381159|NCT02675231|144270493|SUPERIORITY||LS Mean Difference|1.5|STANDARD_ERROR_OF_MEAN|2.7||0.578|TWO_SIDED|||||p-values are from Type 3 sums of squares mixed models repeated measures model (MMRM): Change from baseline = Treatment + Visit + Treatment\*Visit + Baseline.|MMRM Model|||Functional scale: Social functioning||||0.578
72381160|NCT02675231|144270493|SUPERIORITY||LS Mean Difference|-2.9|STANDARD_ERROR_OF_MEAN|2.8||0.308|TWO_SIDED|||||p-values are from Type 3 sums of squares mixed models repeated measures model (MMRM): Change from baseline = Treatment + Visit + Treatment\*Visit + Baseline.|MMRM Model|||Symptom scale: Fatigue||||0.308
72381161|NCT02675231|144270493|SUPERIORITY||LS Mean Difference|4.1|STANDARD_ERROR_OF_MEAN|2.0||0.043|TWO_SIDED|||||p-values are from Type 3 sums of squares mixed models repeated measures model (MMRM): Change from baseline = Treatment + Visit + Treatment\*Visit + Baseline.|MMRM Model|||Symptom scale: Nausea and vomiting||||0.043
72381162|NCT02675231|144270493|SUPERIORITY||LS Mean Difference|-6.8|STANDARD_ERROR_OF_MEAN|3.0||0.026|TWO_SIDED|||||p-values are from Type 3 sums of squares mixed models repeated measures model (MMRM): Change from baseline = Treatment + Visit + Treatment\*Visit + Baseline.|MMRM Model|||Symptom scale: Pain||||0.026
72381163|NCT02675231|144270493|SUPERIORITY||LS Mean Difference|-3.1|STANDARD_ERROR_OF_MEAN|2.8||0.276|TWO_SIDED|||||p-values are from Type 3 sums of squares mixed models repeated measures model (MMRM): Change from baseline = Treatment + Visit + Treatment\*Visit + Baseline.|MMRM Model|||Symptom scale: Dyspnoea||||0.276
72381164|NCT02675231|144270493|SUPERIORITY||LS Mean Difference|-6.4|STANDARD_ERROR_OF_MEAN|3.1||0.041|TWO_SIDED|||||p-values are from Type 3 sums of squares mixed models repeated measures model (MMRM): Change from baseline = Treatment + Visit + Treatment\*Visit + Baseline.|MMRM Model|||Symptom scale: Insomnia||||0.041
72381165|NCT02675231|144270493|SUPERIORITY||LS Mean Difference|3.9|STANDARD_ERROR_OF_MEAN|3.4||0.262|TWO_SIDED|||||p-values are from Type 3 sums of squares mixed models repeated measures model (MMRM): Change from baseline = Treatment + Visit + Treatment\*Visit + Baseline.|MMRM Model|||Symptom scale: Appetite loss||||0.262
72381166|NCT02675231|144270493|SUPERIORITY||LS Mean Difference|-2.9|STANDARD_ERROR_OF_MEAN|2.7||0.285|TWO_SIDED|||||p-values are from Type 3 sums of squares mixed models repeated measures model (MMRM): Change from baseline = Treatment + Visit + Treatment\*Visit + Baseline.|MMRM Model|||Symptom scale: Constipation||||0.285
72381167|NCT02675231|144270493|SUPERIORITY||LS Mean Difference|19.3|STANDARD_ERROR_OF_MEAN|3.2|<|0.001|TWO_SIDED|||||p-values are from Type 3 sums of squares mixed models repeated measures model (MMRM): Change from baseline = Treatment + Visit + Treatment\*Visit + Baseline.|MMRM Model|||Symptom scale: Diarrhoea||||< 0.001
72381168|NCT02675231|144270493|SUPERIORITY||LS Mean Difference|4.0|STANDARD_ERROR_OF_MEAN|3.0||0.18|TWO_SIDED|||||p-values are from Type 3 sums of squares mixed models repeated measures model (MMRM): Change from baseline = Treatment + Visit + Treatment\*Visit + Baseline.|MMRM Model|||Symptom scale: Financial difficulties||||0.180
72381169|NCT02675231|144270494|SUPERIORITY||LS Mean Difference|0.05|STANDARD_ERROR_OF_MEAN|0.02||0.033|TWO_SIDED|||||p-values are from Type 3 sums of squares mixed models repeated measures model: Change from baseline = Treatment + Visit + Treatment\*Visit + Baseline.|MMRM Model|||||||0.033
72381170|NCT02675231|144270494|SUPERIORITY||LS Mean Difference|0.03|STANDARD_ERROR_OF_MEAN|0.02||0.275|TWO_SIDED|||||p-values are from Type 3 sums of squares mixed models repeated measures model: Change from baseline = Treatment + Visit + Treatment\*Visit + Baseline.|MMRM Model|||||||0.275
72381171|NCT02675231|144270495|SUPERIORITY||LS Mean Difference|1.22|STANDARD_ERROR_OF_MEAN|2.02||0.546|TWO_SIDED||||||MMRM Model|||||||0.546
72381172|NCT02675231|144270495|SUPERIORITY||LS Mean Difference|-1.02|STANDARD_ERROR_OF_MEAN|2.1||0.62|TWO_SIDED||||||MMRM Model|||||||0.620
72381173|NCT05014490|144270497|EQUIVALENCE|The ANOVA model was utilized in comparing the effects between the test and reference products. The level of significance was set to the standard value of 5% (0.05) for all statistical tests.|Ratio of the T/R geometric mean x 100|102.15|||||TWO_SIDED|90.0|94.54|110.37|||||The ratio of geometric LSmeans with corresponding 90% CI calculated from the exponential of the difference between the test and reference products for the ln-transformed parameters should be within the acceptance interval of 80.00 - 125.00%.|||110.37|94.54|
72618616|NCT01026038|144768106|SUPERIORITY_OR_OTHER||GMC ratio|1.05|||||TWO_SIDED|95.0|0.66|1.68||||||Serotype 19F: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||1.68|0.66|
72381174|NCT05014490|144270498|EQUIVALENCE|The ANOVA model was utilized in comparing the effects between the test and reference products. The level of significance was set to the standard value of 5% (0.05) for all statistical tests.|Ratio of the T/R geometric mean x 100|99.23|||||TWO_SIDED|90.0|96.97|101.54|||||The ratio of geometric LSmeans with corresponding 90% CI calculated from the exponential of the difference between the test and reference products for the ln-transformed parameters should be within the acceptance interval of 80.00 - 125.00%.|||101.54|96.97|
72381175|NCT03880461|144270513|SUPERIORITY|||||||0.014|||||||t-test, 2 sided|||||||0.014
72381176|NCT03880461|144270514|SUPERIORITY|||||||0.003|||||||t-test, 2 sided|||||||0.003
72381177|NCT03880461|144270515|SUPERIORITY|||||||0.108|||||||ANOVA|||||||0.108
72381178|NCT04025710|144270541|OTHER|single arm design|SADE-free rate|0.97||||0.05|TWO_SIDED|95.0|0.9|1.0|||t-test, 2 sided|||The primary hypothesis evaluates the SADE free rate (pSADE\_free) at 3 months. Ho: SADE-free rate through 3 months post-implant ≤ 90.0% Ha: SADE-free rate through 3 months post-implant \> 90.0%||1|0.9|0.05
72381179|NCT02431247|144270546|NON_INFERIORITY|One-sided p-value for non-inferiority of Test versus Control arm. The non-|Difference in percentage|2.7|||<|0.001|TWO_SIDED|95.0|-1.6|7.1||inferiority margin is 10%.|Mantel Haenszel|||||7.1|-1.6|< 0.001
72381180|NCT02431247|144270549|OTHER||Least square mean difference|-0.05|STANDARD_ERROR_OF_MEAN|0.063|=|0.437|TWO_SIDED|95.0|-0.171|0.074|||ANCOVA|||||0.074|-0.171|= 0.437
72381181|NCT02431247|144270550|OTHER||LS mean difference|18.48|STANDARD_ERROR_OF_MEAN|14.808|=|0.213|TWO_SIDED|95.0|-10.595|47.55|||ANCOVA|||||47.550|-10.595|= 0.213
72381182|NCT02431247|144270551|OTHER||LS mean difference|-0.04|STANDARD_ERROR_OF_MEAN|0.008|<|0.001|TWO_SIDED|95.0|-0.05|-0.02|||ANCOVA|||||-0.02|-0.05|< 0.001
72381183|NCT02431247|144270552|OTHER||LS mean difference|3.12|STANDARD_ERROR_OF_MEAN|0.786|<|0.001|TWO_SIDED|95.0|1.57|4.66|||ANCOVA|||||4.66|1.57|< 0.001
72381184|NCT02431247|144270553|OTHER||LS mean difference|6.04|STANDARD_ERROR_OF_MEAN|1.126|<|0.001|TWO_SIDED|95.0|3.83|8.25|||ANCOVA|||||8.25|3.83|< 0.001
72381185|NCT02431247|144270554|OTHER||LS mean difference|2.4|STANDARD_ERROR_OF_MEAN|0.747|=|0.001|TWO_SIDED|95.0|0.93|3.87|||ANCOVA|||||3.87|0.93|= 0.001
72381186|NCT02431247|144270556|OTHER||||||=|0.033|||||||Wilcoxon rank sum test|||||||= 0.033
72381187|NCT02431247|144270557|OTHER||||||=|0.033|||||||Wilcoxon rank sum test|||||||= 0.033
72381188|NCT02431247|144270558|OTHER||||||<|0.001|||||||Wilcoxon rank sum test|||||||< 0.001
72381189|NCT02431247|144270559|OTHER||||||<|0.001|||||||Wilcoxon rank sum test|||||||< 0.001
72381190|NCT02431247|144270560|OTHER||||||=|0.147|||||||Wilcoxon rank sum test|||||||= 0.147
72381191|NCT02431247|144270565|OTHER||LS mean difference|1.95|STANDARD_ERROR_OF_MEAN|0.368|<|0.001|TWO_SIDED|95.0|1.227|2.678|||ANCOVA|||Hip region BMD (Week 24)||2.678|1.227|< 0.001
72381192|NCT02431247|144270565|OTHER||LS mean difference|2.86|STANDARD_ERROR_OF_MEAN|0.47|<|0.001|TWO_SIDED|95.0|1.934|3.791|||ANCOVA|||Hip region BMD (Week 48)||3.791|1.934|< 0.001
72381193|NCT02431247|144270565|OTHER||LS mean difference|2.09|STANDARD_ERROR_OF_MEAN|0.421|<|0.001|TWO_SIDED|95.0|1.259|2.919|||ANCOVA|||Spine region BMD (Week 24)||2.919|1.259|< 0.001
72381194|NCT02431247|144270565|OTHER||LS mean difference|1.7|STANDARD_ERROR_OF_MEAN|0.588|=|0.004|TWO_SIDED|95.0|0.539|2.858|||ANCOVA|||Spine region BMD (Week 48)||2.858|0.539|= 0.004
72381195|NCT01369485|144270605|SUPERIORITY_OR_OTHER|||||||0.3636|||||||Chi-squared|||The sample size calculation was determined using the 2-sided Chi-square test with a significance level of 5% and 80% power based upon the following assumptions: (1) proportion of responders at end of 12 weeks of treatment would be 50% in the active (test) group and 25% in the inactive (control) group; (2) a responder was defined as a subject who experienced decrease of ≥50% in mean urgency urinary incontinence episodes (leaks) between baseline and Week 12 of the study; (3) 20 % dropout rate.||||0.3636
72381196|NCT01369485|144270605|SUPERIORITY_OR_OTHER|||||||0.4849|||||||Chi-squared|||||||0.4849
72381197|NCT01369485|144270606|SUPERIORITY_OR_OTHER|||||||0.2893|||||||Wilcoxon (Mann-Whitney)|||||||0.2893
72381198|NCT01369485|144270606|SUPERIORITY_OR_OTHER|||||||0.3223|||||||Wilcoxon (Mann-Whitney)|||||||0.3223
72381199|NCT01369485|144270607|SUPERIORITY_OR_OTHER|||||||0.3387|||||||Wilcoxon (Mann-Whitney)|||||||0.3387
72381200|NCT01369485|144270608|SUPERIORITY_OR_OTHER|||||||0.6557|||||||Wilcoxon (Mann-Whitney)|||||||0.6557
72381201|NCT01369485|144270609|SUPERIORITY_OR_OTHER|||||||0.4354|||||||Wilcoxon (Mann-Whitney)|||||||0.4354
72381202|NCT01369485|144270610|SUPERIORITY_OR_OTHER|||||||0.9918|||||||Wilcoxon (Mann-Whitney)|||||||0.9918
72381203|NCT01369485|144270610|SUPERIORITY_OR_OTHER|||||||0.377|||||||Wilcoxon (Mann-Whitney)|||||||0.3770
72381204|NCT01369485|144270611|SUPERIORITY_OR_OTHER|||||||0.4147|||||||Fisher Exact|||||||0.4147
72381205|NCT01369485|144270611|SUPERIORITY_OR_OTHER|||||||0.0877|||||||Fisher Exact|||||||0.0877
72381206|NCT01369485|144270612|SUPERIORITY_OR_OTHER|||||||0.2032|||||||Fisher Exact|||||||0.2032
72381207|NCT01369485|144270613|SUPERIORITY_OR_OTHER|||||||0.4151||||||Calculated for only those patients who had prior OAB treatment only.|Wilcoxon (Mann-Whitney)|||||||0.4151
72381208|NCT01369485|144270614|SUPERIORITY_OR_OTHER|||||||0.9814|||||||Fisher Exact|||"Endpoint defined as percentage of patients that much improved or very much improved following treatment."||||0.9814
72381209|NCT01369485|144270614|SUPERIORITY_OR_OTHER|||||||0.7305|||||||Fisher Exact|||||||0.7305
72381210|NCT01369485|144270615|SUPERIORITY_OR_OTHER|||||||0.2191|||||||Wilcoxon (Mann-Whitney)|||||||0.2191
72381211|NCT01369485|144270615|SUPERIORITY_OR_OTHER|||||||0.5357|||||||Wilcoxon (Mann-Whitney)|||||||0.5357
72381212|NCT01858636|144270617|SUPERIORITY_OR_OTHER|||||||0.0029|TWO_SIDED||||||Fisher Exact|A one-sided Fisher's exact test was performed with a 95% upper confidence bound of 5.5%||Ho: Pt ≥ 8% Ha: Pt \< 8%, where Pt is the proportion of deployed subjects with a protocol-defined vascular complication.||||0.0029
72381213|NCT01858636|144270618|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Fisher Exact|A one-sided Fisher's exact test was performed with a 95% lower confidence bound of 96.4%||Ho: St ≤ 90% Ha: St \> 90%, where St is the proportion of deployed subjects achieving hemostasis within 5 minutes.||||<0.0001
72381214|NCT04616027|144270637|OTHER|ANOVA|Ratio (Test/Reference) of Adjusted Means|99.67|||||TWO_SIDED|90.0|70.15|141.6||||||"T2DM Normal Renal Function was test, Healthy and Normal Renal Function was reference."||141.60|70.15|
72381215|NCT04616027|144270637|OTHER|ANOVA|Ratio (Test/Reference) of Adjusted Means|101.34|||||TWO_SIDED|90.0|70.51|145.63||||||"T2DM Mild Renal Impairment was test, T2DM Normal Renal Function was reference."||145.63|70.51|
72381216|NCT04616027|144270637|OTHER|ANOVA|Ratio (Test/Reference) of Adjusted Means|146.56|||||TWO_SIDED|90.0|103.16|208.22||||||"T2DM Moderate Renal Impairment was test, T2DM Normal Renal Function was reference."||208.22|103.16|
72381217|NCT04616027|144270637|OTHER|ANOVA|Ratio (Test/Reference) of Adjusted Means|101.31|||||TWO_SIDED|90.0|71.31|143.92||||||"T2DM Severe Renal Impairment was test, T2DM Normal Renal Function was reference."||143.92|71.31|
72381218|NCT04616027|144270638|OTHER|ANOVA|Ratio (Test/Reference) of Adjusted Means|111.71|||||TWO_SIDED|90.0|79.52|156.93||||||"T2DM Normal Renal Function was test, Healthy and Normal Renal Function was reference."||156.93|79.52|
72381219|NCT04616027|144270638|OTHER|ANOVA|Ratio (Test/Reference) of Adjusted Means|120.31|||||TWO_SIDED|90.0|83.49|173.38||||||"T2DM Mild Renal Impairment was test, T2DM Normal Renal Function was reference."||173.38|83.49|
72381220|NCT04616027|144270638|OTHER|ANOVA|Ratio (Test/Reference) of Adjusted Means|134.18|||||TWO_SIDED|90.0|94.46|190.62||||||"T2DM Moderate Renal Impairment was test, T2DM Normal Renal Function was reference."||190.62|94.46|
72381221|NCT04616027|144270638|OTHER|ANOVA|Ratio (Test/Reference) of Adjusted Means|100.99|||||TWO_SIDED|90.0|71.89|141.87||||||"T2DM Severe Renal Impairment was test, T2DM Normal Renal Function was reference."||141.87|71.89|
72381222|NCT04616027|144270639|OTHER|ANOVA|Ratio (Test/Reference) of Adjusted Means|111.02|||||TWO_SIDED|90.0|79.6|154.86||||||"T2DM Normal Renal Function was test, Healthy and Normal Renal Function was reference."||154.86|79.60|
72381223|NCT04616027|144270639|OTHER|ANOVA|Ratio (Test/Reference) of Adjusted Means|116.7|||||TWO_SIDED|90.0|82.76|164.56||||||"T2DM Mild Renal Impairment was test, T2DM Normal Renal Function was reference."||164.56|82.76|
72381224|NCT04616027|144270639|OTHER|ANOVA|Ratio (Test/Reference) of Adjusted Means|134.68|||||TWO_SIDED|90.0|96.56|187.85||||||"T2DM Moderate Renal Impairment was test, T2DM Normal Renal Function was reference."||187.85|96.56|
72381225|NCT04616027|144270639|OTHER|ANOVA|Ratio (Test/Reference) of Adjusted Means|101.31|||||TWO_SIDED|90.0|72.63|141.3||||||"T2DM Severe Renal Impairment was test, T2DM Normal Renal Function was reference."||141.30|72.63|
72381226|NCT04616027|144270640|OTHER|ANOVA|Ratio (Test/Reference) of Adjusted Means|101.52|||||TWO_SIDED|90.0|88.89|115.94||||||"T2DM Normal Renal Function was test, Healthy and Normal Renal Function was reference."||115.94|88.89|
72381227|NCT04616027|144270640|OTHER|ANOVA|Ratio (Test/Reference) of Adjusted Means|110.17|||||TWO_SIDED|90.0|96.05|126.37||||||"T2DM Mild Renal Impairment was test, T2DM Normal Renal Function was reference."||126.37|96.05|
72381228|NCT04616027|144270640|OTHER|ANOVA|Ratio (Test/Reference) of Adjusted Means|120.63|||||TWO_SIDED|90.0|105.63|137.77||||||"T2DM Moderate Renal Impairment was test, T2DM Normal Renal Function was reference."||137.77|105.63|
72381229|NCT04616027|144270640|OTHER|ANOVA|Ratio (Test/Reference) of Adjusted Means|127.06|||||TWO_SIDED|90.0|111.26|145.12||||||"T2DM Severe Renal Impairment was test, T2DM Normal Renal Function was reference."||145.12|111.26|
72381230|NCT03737851|144270655|OTHER|a statistical test was not performed|Odds Ratio (OR)|1.202|||||TWO_SIDED|95.0|0.559|2.584||||||Logistic regression model for EDSS+ includes baseline values for EDSS, Timed 25-Foot Walk, 9-Hole Peg Test-dominant, 9-Hole Peg Test-nondominant, and treatment as a main effect. Subjects with missing values were imputed as non-responders.||2.584|0.559|
72381231|NCT03737851|144270655|OTHER|a statistical test was not performed|Odds Ratio (OR)|0.615|||||TWO_SIDED|95.0|0.266|1.421||||||Logistic regression model for EDSS+ includes baseline values for EDSS, Timed 25-Foot Walk, 9-Hole Peg Test-dominant, 9-Hole Peg Test-nondominant, and treatment as a main effect. Subjects with missing values were imputed as non-responders.||1.421|0.266|
72381232|NCT05032859|144270737|SUPERIORITY||Risk Ratio, log|2.27|||<|0.0001|TWO_SIDED|95.0|1.54|3.32|||Cochran-Mantel-Haenszel|Stratified by Baseline vIGA-AD Score and Age Group|Adjusted logit-based estimate of the common relative risk of success (Tapinarof Cream 1%/Vehicle Cream) over all strata. Multiple imputation p-value is for null hypothesis that the log (Relative Risk) equals 0.|H0: The proportion of subjects who achieve a vIGA-AD score of clear (0) or almost clear (1) and at least a 2-grade reduction from Baseline at Week 8 is equal between tapinarof cream, 1% and vehicle cream; H1: The proportion of subjects who achieve a vIGA-AD score of clear (0) or almost clear (1) and at least a 2-grade reduction from Baseline at Week 8 is different between the tapinarof cream, 1% and vehicle cream.||3.32|1.54|<0.0001
72381233|NCT05032859|144270738|SUPERIORITY||Risk Ratio, log|2.14|||<|0.0001|TWO_SIDED|95.0|1.53|3.0|||Cochran-Mantel-Haenszel|Stratified by vIGA-AD score at Baseline (vIGA-AD scores of 3 or 4) and age group (2-6 yrs, 7-11 yrs, 12-17 yrs, 18+ yrs)|Adjusted logit-based estimate of the common relative risk of success (Tapinarof Cream 1%/Vehicle Cream) over all strata. Multiple imputation p-value is for null hypothesis that the log (Relative Risk) equals 0.|||3.00|1.53|<0.0001
72381234|NCT05032859|144270739|SUPERIORITY||Least squares mean difference|-6.6|STANDARD_ERROR_OF_MEAN|0.803|<|0.0001|TWO_SIDED|95.0|-8.17|-5.02|||ANCOVA|age\*vIGA cohort and treatment as categorical covariates, and baseline %BSA as a continuous covariate||||-5.02|-8.17|<0.0001
72618617|NCT01026038|144768106|SUPERIORITY_OR_OTHER||GMC ratio|1.54|||||TWO_SIDED|95.0|0.97|2.44||||||Serotype 19F: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||2.44|0.97|
72381235|NCT05032859|144270740|SUPERIORITY||Risk Ratio, log|2.34||||0.0013|TWO_SIDED|95.0|1.39|3.94|||Cochran-Mantel-Haenszel|Stratified by Baseline vIGA-AD Score and Age Group|Adjusted logit-based estimate of the common relative risk of success (Tapinarof Cream 1%/Vehicle Cream) over all strata. Multiple imputation p-value is for null hypothesis that the log (Relative Risk) equals 0.||Adjusted logit-based estimate of the common relative risk of success (Tapinarof Cream 1%/Vehicle Cream) over all strata. Multiple imputation p-value is for null hypothesis that the log (Relative Risk) equals 0.|3.94|1.39|0.0013
72381236|NCT05032859|144270741|SUPERIORITY||Risk Ratio, log|2.17||||0.0015|TWO_SIDED|95.0|1.34|3.5|||Cochran-Mantel-Haenszel|Stratified by Baseline vIGA-AD Score and Age Group|Adjusted logit-based estimate of the common relative risk of success (Tapinarof Cream 1%/Vehicle Cream) over all strata. Multiple imputation p-value is for null hypothesis that the log (Relative Risk) equals 0.|||3.50|1.34|0.0015
72381237|NCT01535664|144270742|SUPERIORITY_OR_OTHER||Difference in least square means|4.04|STANDARD_ERROR_OF_MEAN|1.51||0.015|TWO_SIDED|95.0|0.87|7.2||A step-down procedure using the primary statistical analysis was followed. If the p-value for the overall gait was less than 0.05, then overall balance was tested in the same manner. Otherwise, the testing procedure was stopped.|Mixed Models Analysis|P-value is based on a mixed model ANOVA with a fixed effect for treatment.||The co-primary efficacy variable was overall gait. This novel composite score was created from standardized individual NeuroCom test results (Z-scores). Overall gait was the average of WA, TW, and SQT; a higher score is indicative of better performance.||7.20|0.87|0.015
72381238|NCT01535664|144270743|SUPERIORITY_OR_OTHER||Difference in least square means|1.7|STANDARD_ERROR_OF_MEAN|0.5||0.003|TWO_SIDED|95.0|0.7|2.8|||Mixed Models Analysis|P-value is based on a mixed model ANOVA with a fixed effect for treatment||||2.8|0.7|0.003
72381239|NCT01535664|144270744|SUPERIORITY_OR_OTHER||Difference in least square means|7.729|STANDARD_ERROR_OF_MEAN|2.495||0.006|TWO_SIDED|95.0|2.507|12.95|||Mixed Models Analysis|P-value is based on a mixed model ANOVA with a fixed effect for treatment||||12.950|2.507|0.006
72381240|NCT01535664|144270745|SUPERIORITY_OR_OTHER||Difference in least square means|0.36|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|0.19|0.54|||Mixed Models Analysis|P-value is based on a mixed model ANOVA with a fixed effect for treatment||||0.54|0.19|<.001
72381241|NCT01535664|144270746|SUPERIORITY_OR_OTHER||Difference in least square means|-2.38|STANDARD_ERROR_OF_MEAN|2.97||0.434|TWO_SIDED|95.0|-8.6|3.84||A step-down procedure using the primary statistical analysis was followed. If the p-value for the overall gait was less than 0.05, then overall balance was tested in the same manner. Otherwise, the testing procedure was stopped.|Mixed Models Analysis|P-value is based on a mixed model ANOVA with a fixed effect for treatment||The co-primary efficacy variable was overall balance. This novel composite score was created from standardized individual NeuroCom test results (Z-scores). Overall balance was a weighted average of SOT, LOS, and ADT.||3.84|-8.60|0.434
72381242|NCT01885871|144270763|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.0001
72381243|NCT00090051|144270785|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.76||||0.0218|TWO_SIDED|95.0|0.6|0.96|||Log Rank|non-stratified|The hazard ratio was estimated using Cox regression. The hazard ratio is relative to the fludarabine+cyclophosphamide(FC) group.|The null hypothesis was that there was no difference between the 2 treatment groups. The alternative hypothesis was that progression-free survival was longer in the fludarabine+cyclophosphamide+rituximab (FCR) group.||0.96|0.60|0.0218
72381244|NCT00090051|144270786|SUPERIORITY_OR_OTHER|||||||0.2874||95.0|||||Log Rank|non-stratified||||||0.2874
72381245|NCT00090051|144270788|SUPERIORITY_OR_OTHER|||||||0.0002||95.0|||||Log Rank|non-stratified||||||0.0002
72381246|NCT00090051|144270791|SUPERIORITY_OR_OTHER|||||||0.8842||95.0|||||Log Rank|non-stratified||||||0.8842
72381247|NCT00090051|144270793|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.66|||<|0.0001|TWO_SIDED|95.0|0.54|0.8|||Log Rank|||||0.80|0.54|<.0001
72381248|NCT00090051|144270794|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.94||||0.5976|TWO_SIDED|95.0|0.74|1.19|||Log Rank|||||1.19|0.74|0.5976
72381249|NCT00090051|144270795|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.65|||<|0.0001|TWO_SIDED|95.0|0.54|0.79|||Log Rank|||||0.79|0.54|<.0001
72381250|NCT00090051|144270796|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.15||||0.0005|TWO_SIDED|95.0|1.39|3.35|||Chi-squared|||||3.35|1.39|0.0005
72381251|NCT00090051|144270797|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.77||||0.3085|TWO_SIDED|95.0|0.46|1.28|||Log Rank|||||1.28|0.46|0.3085
72618618|NCT01026038|144768106|SUPERIORITY_OR_OTHER||GMC ratio|1.46|||||TWO_SIDED|95.0|0.85|2.51||||||Serotype 19F: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||2.51|0.85|
72618619|NCT01026038|144768106|SUPERIORITY_OR_OTHER||GMC ratio|0.8|||||TWO_SIDED|95.0|0.56|1.15||||||Serotype 23F: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||1.15|0.56|
72381252|NCT00090051|144270798|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.65||||0.0007|TWO_SIDED|95.0|0.51|0.84|||Log Rank|||||0.84|0.51|0.0007
72381253|NCT00090051|144270799|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.68||||0.0002|TWO_SIDED|95.0|0.55|0.84|||Log Rank|||||0.84|0.55|0.0002
72381254|NCT01896479|144270846|NON_INFERIORITY|The non-inferiority margin used was 1.58.|Cox Proportional Hazard|1.24||||0.1916|TWO_SIDED|95.0|0.9|1.7||Stratification factors comprised RET M918T mutational status (positive, negative, and unknown).|Log Rank|||||1.70|0.90|0.1916
72381255|NCT01896479|144270847|OTHER|Descriptive statistical analysis.|Odds Ratio (OR)|1.0195||||0.9437|TWO_SIDED|95.0|0.6|1.7|||Cochran-Mantel-Haenszel|Stratification factors comprised RET M918T mutational status (positive, negative, and unknown).||||1.7|0.6|0.9437
72381256|NCT00433511|144270848|SUPERIORITY||Hazard Ratio (HR)|0.87||||0.17|TWO_SIDED|95.0|0.71|1.06||Two-sided; based on stratified test using stratification factors at randomization.|Regression, Cox||Hazard ratio: Arm C/Arm A|The primary objective of this trial was to determine whether the addition of bevacizumab improved IDFS. A two-step hierarchical approach was used. In the 1st step, Arm C was to be compared to Arm A. If Arm C significantly improved IDFS relative to Arm A, then in the 2nd step, a comparison of Arm B to Arm A was to be performed. If the treatment in both Arm C and Arm B significantly improved IDFS relative to Arm A, then a comparison of Arm C to Arm B was to be performed with respect to IDFS.||1.06|0.71|0.17
72381257|NCT00433511|144270849|SUPERIORITY||Hazard Ratio (HR)|0.89||||0.41|TWO_SIDED|95.0|0.68|1.17||Two-sided; based on stratified test using stratification factors at randomization.|Regression, Cox||Hazard ratio: Arm C/Arm A|||1.17|0.68|0.41
72381258|NCT00433511|144270849|SUPERIORITY||Hazard Ratio (HR)|1.01||||0.92|TWO_SIDED|95.0|0.77|1.33||Two-sided; based on stratified test using stratification factors at randomization.|Regression, Cox||Hazard ratio: Arm B/Arm A|||1.33|0.77|0.92
72381259|NCT00433511|144270849|SUPERIORITY||Hazard Ratio (HR)|0.9||||0.36|TWO_SIDED|95.0|0.72|1.13||Two-sided; based on stratified test using stratification factors at randomization|Regression, Cox||Hazard ratio: Arm C/Arm B|||1.13|0.72|0.36
72381260|NCT03139604|144270851|OTHER||Odds Ratio (OR)|1.45||||0.0782|TWO_SIDED|95.0|0.959|2.204||Not adjusted for multiplicity with interim and final analyses|Cochran-Mantel-Haenszel|||binomial distribution||2.204|0.959|0.0782
72381261|NCT05007717|144270886|SUPERIORITY||Risk Ratio (RR)|1.04||||0.631|TWO_SIDED|95.0|0.89|1.2|||Mixed Models Analysis|Adjusted for ever missing a visit during a 6 months pre-enrollment period and always coming to clinic by yourself.||||1.20|0.89|0.631
72381262|NCT05007717|144270887|SUPERIORITY||Risk Ratio (RR)|0.79||||0.237|TWO_SIDED|95.0|0.54|1.16|||Mixed Models Analysis|Adjusted for ever being virally unsuppressed during a 6 months pre-enrollment period and always coming to clinic by yourself.||||1.16|0.54|0.237
72381263|NCT05007717|144270888|SUPERIORITY||Risk Ratio (RR)|0.98||||0.386|TWO_SIDED|95.0|0.94|1.02|||Mixed Models Analysis|Adjusted for always having \>80% coverage during a 6 months pre-enrollment period and always coming to clinic by yourself.||||1.02|0.94|0.386
72381264|NCT05007717|144270889|SUPERIORITY||Hazard Ratio (HR)|1.0||||0.991|TWO_SIDED|95.0|0.71|1.41|||Regression, Cox|Adjusted for always coming to clinic by yourself.||||1.41|0.71|0.991
72381265|NCT05007717|144270890|SUPERIORITY||Risk Ratio (RR)|1.21||||0.037|TWO_SIDED|95.0|1.01|1.46|||Mixed Models Analysis|Adjusted for having been given fast track visits during a 6 months pre-enrollment period and always coming to clinic by yourself.||||1.46|1.01|0.037
72381266|NCT05007717|144270891|SUPERIORITY||Risk Ratio (RR)|1.04||||0.276|TWO_SIDED|95.0|0.97|1.12|||Mixed Models Analysis|Adjusted for having been given long intervals during a 6 months pre-enrollment period and always coming to clinic by yourself.||||1.12|0.97|0.276
72381267|NCT02840240|144270903|NON_INFERIORITY|Noninferiority deltas were defined a priori as 1.1 for the ratio in geometric means of opioid consumption converted to IV morphine equivalents (ie, no more than 10% difference between group's median doses) and 1 point for pain score (ie, no more than 1 point worse).|Mean Difference (Final Values)|-0.19||||0.003|TWO_SIDED|95.0|-1.07|0.69|||Regression, Linear|||||0.69|-1.07|0.003
72381268|NCT02840240|144270904|NON_INFERIORITY|Noninferiority deltas were defined a priori as 1.1 for the ratio in geometric means of opioid consumption converted to IV morphine equivalents (ie, no more than 10% difference between group's median doses) and 1 point for pain score (ie, no more than 1 point worse).|Ratio of geometric means|2.12||||0.77|TWO_SIDED|95.0|0.21|18.54|||Regression, Linear|||Comparisons of opioid consumption were conducted independently for each study site. This analysis is for patients at the Cleveland Clinic main campus.||18.54|0.21|0.77
72504924|NCT01183858|144540906|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.05||||0.671|TWO_SIDED|95.0|0.83|1.33||Unstratified analysis.|Log Rank|||||1.33|0.83|0.671
72504925|NCT01183858|144540912|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.06||||0.625|TWO_SIDED|95.0|0.84|1.33|||Log Rank|||||1.33|0.84|0.625
72381269|NCT02840240|144270904|NON_INFERIORITY|Noninferiority deltas were defined a priori as 1.1 for the ratio in geometric means of opioid consumption converted to IV morphine equivalents (ie, no more than 10% difference between group's median doses) and 1 point for pain score (ie, no more than 1 point worse).|Ratio of geometric means|0.32||||0.09|TWO_SIDED|95.0|0.03|3.16|||Regression, Linear|||Comparisons of opioid consumption were conducted independently for each study site. This analysis is for patients at the Cleveland Clinic Fairview hospital.||3.16|0.03|0.09
72381270|NCT02840240|144270905|SUPERIORITY||Odds Ratio (OR)|3.5||||0.11|TWO_SIDED|98.75|0.5|24.3|||Regression, Logistic|||||24.3|0.5|0.11
72381271|NCT02840240|144270906|SUPERIORITY||Odds Ratio (OR)|0.7||||0.6|TWO_SIDED|98.75|0.2|3.1|||Regression, Logistic|||||3.1|0.2|0.60
72381272|NCT02007512|144270915|OTHER||Hazard Ratio (HR)|0.82||||0.3631|TWO_SIDED|95.0|0.535|1.257|||Stratified log-rank|||Hazard ratio was based on stratified Cox regression model.||1.257|0.535|0.3631
72381273|NCT02007512|144270915|OTHER||Hazard Ratio (HR)|1.022||||0.9212|TWO_SIDED|95.0|0.659|1.586|||Stratified log-rank|||Hazard ratio was based on stratified Cox regression model.||1.586|0.659|0.9212
72381274|NCT02007512|144270916|OTHER||Hazard Ratio (HR)|0.442||||0.0335|TWO_SIDED|95.0|0.205|0.955|||Stratified log-rank|||Hazard ratio was based on stratified Cox regression model.||0.955|0.205|0.0335
72381275|NCT02007512|144270916|OTHER||Hazard Ratio (HR)|0.554||||0.1936|TWO_SIDED|95.0|0.225|1.363|||Stratified log-rank|||Hazard ratio was based on stratified Cox regression model.||1.363|0.225|0.1936
72381276|NCT02007512|144270933|OTHER||Hazard Ratio (HR)|0.928||||0.7378|TWO_SIDED|95.0|0.599|1.438|||Stratified log-rank|||Hazard ratio was based on stratified Cox regression model.||1.438|0.599|0.7378
72381277|NCT02007512|144270933|OTHER||Hazard Ratio (HR)|0.968||||0.8817|TWO_SIDED|95.0|0.632|1.483|||Stratified log-rank|||Hazard ratio was based on stratified Cox regression model.||1.483|0.632|0.8817
72433653|NCT00991276|144380393|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-7.58|STANDARD_ERROR_OF_MEAN|3.26||0.0215|TWO_SIDED|95.0|-14.03|-1.14||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||-1.14|-14.03|0.0215
72556489|NCT02842853|144644207|EQUIVALENCE|Lot consistency was demonstrated across the 3 lots, if, for each pair of lots and each antigen, the 2-sided 95% CI for the ratio of the GMTs lies between 1/2 and 2.|GMT Ratio|0.867|||||TWO_SIDED|95.0|0.74|1.02||||||Serogroup A: Lot 1 vs Lot 3||1.02|0.740|
72381278|NCT02007512|144270934|OTHER||Hazard Ratio (HR)|0.522||||0.127|TWO_SIDED|95.0|0.224|1.217|||Stratified log-rank|||Hazard ratio was based on stratified Cox regression model.||1.217|0.224|0.1270
72381279|NCT02007512|144270934|OTHER||Hazard Ratio (HR)|0.37||||0.0359|TWO_SIDED|95.0|0.143|0.961|||Stratified log-rank|||Hazard ratio was based on stratified Cox regression model.||0.961|0.143|0.0359
72381280|NCT01466595|144270984|SUPERIORITY_OR_OTHER|||||||0.028||||||not adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|no other adjustments||"Null hypothesis:~There is no difference between the two arms in the change in T-cell activation from baseline to week 4"||||0.028
72381281|NCT02117414|144271034|SUPERIORITY_OR_OTHER||Percentage|100.0|||<|0.0001|ONE_SIDED|95.0|97.75|||A priori threshold for statistical significance was 0.025.|one-proportion binomial exact test|||The alternative hypothesis is that the MRI-related event-free rate between the MRI procedure and one month post-MRI is greater than 90%. The null hypothesis will be rejected if the one-sided 97.5% lower confidence bound is greater than 90% or, equivalently, if the p-value is less than 0.025. Assuming type I error rate 0.025, even-free rate under null hypothesis 90% and true even-free rate 0.995, the minimum required sample size is 54 MRI scanned subjects in order to obtain 90% power.|||97.75|<0.0001
72381282|NCT02117414|144271035|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin was 10%.|Difference in percentages|1.2|||<|0.0001|ONE_SIDED|95.0|-3.8|||A priori threshold for statistical significance was 0.025.|Farrington-Manning non-inferiority test|||"The percentage of subjects who experience a VPCT increase less than or equal to 0.5V from the pre-MRI/waiting period to one month post-MRI/waiting period in the MRI group is greater than that in the Control group minus 10%.~H0: % successes MRI group ≤ % successes Control group - 10% HA: % successes MRI group \> % successes Control group - 10%"|||-3.8|<0.0001
72381283|NCT02117414|144271036|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin is 8%.|Difference in percentages|0.6||||0.0001|ONE_SIDED|95.0|-4.1|||A priori threshold for statistical significance was 0.025.|Farrington-Manning non-inferiority test|||"The percentage of subjects who do not experience a significant decrease in ventricular sensing amplitude from the pre-MRI/waiting period to one month post-MRI/waiting period is greater than that in the Control group minus 8%.~H0: % successes MRI group ≤ % successes Control group - 8% HA: % successes MRI group \> % successes Control group - 8%"|||-4.1|0.0001
72381284|NCT02117414|144271037|NON_INFERIORITY_OR_EQUIVALENCE|The null hypothesis will be rejected if the one-sided 95% log-log transformed lower confidence bound at 120 days post-implant calculated using Kaplan-Meier (K-M) method is greater than 80%.|Complication-free rate|95.9|||<|0.0001|ONE_SIDED|95.0|93.0|||A priori threshold for statistical significance was 0.05.|Kaplan-Meier method|||"The system-related complication-free rate between the implant procedure and the one month post-MRI/waiting period is greater than 80%.~H0: p ≤ 0.80 HA: p \> 0.80 where p is the system-related complication-free rate between the implant procedure and 120 days (the approximate time of the one month post-MRI/waiting period visit)."|||93.0|<0.0001
72381285|NCT02117414|144271038|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin is 10%.|Difference in percentages|1.2|||<|1e-05|ONE_SIDED|90.0|-3.1|||A priori threshold for statistical significance was 0.05.|Farrington-Manning non-inferiority test|||"The percentage of subjects who have a defibrillation impedance between 20 and 100 ohms at the one month post-MRI/waiting period visit in the MRI group is greater than that in the Control group minus 10%.~H0: % successes MRI group ≤ % successes Control group - 10% HA: % successes MRI group \> % successes Control group - 10% Where % successes means the % of subjects whose defibrillation impedance at the one month post-MRI/waiting period visit is between 20 and 100 ohms."|||-3.1|<0.00001
72618620|NCT01026038|144768106|SUPERIORITY_OR_OTHER||GMC ratio|1.06|||||TWO_SIDED|95.0|0.74|1.52||||||Serotype 23F: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.52|0.74|
72618621|NCT01026038|144768106|SUPERIORITY_OR_OTHER||GMC ratio|1.32|||||TWO_SIDED|95.0|0.87|2.01||||||Serotype 23F: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||2.01|0.87|
72433654|NCT00991276|144380393|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|1.9|STANDARD_ERROR_OF_MEAN|3.23||0.5569|TWO_SIDED|95.0|-4.49|8.29||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||8.29|-4.49|0.5569
72433655|NCT00991276|144380393|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-9.48|STANDARD_ERROR_OF_MEAN|3.2||0.0036|TWO_SIDED|95.0|-15.81|-3.16||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||-3.16|-15.81|0.0036
72433656|NCT00991276|144380394|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.71|STANDARD_ERROR_OF_MEAN|1.8||0.6947|TWO_SIDED|95.0|-2.85|4.27||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||Awaken Short of Breath/with Headache: P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||4.27|-2.85|0.6947
72433657|NCT00991276|144380394|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.52|STANDARD_ERROR_OF_MEAN|1.79||0.398|TWO_SIDED|95.0|-5.06|2.02||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||Awaken Short of Breath/with Headache: P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||2.02|-5.06|0.3980
72433658|NCT00991276|144380394|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|2.23|STANDARD_ERROR_OF_MEAN|1.78||0.2144|TWO_SIDED|95.0|-1.3|5.76||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||Awaken Short of Breath/with Headache: P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||5.76|-1.30|0.2144
72381286|NCT02117414|144271039|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin is 10%|Difference in percentages|0.0|||||TWO_SIDED|||||A priori threshold for statistical significance was 0.05. Because the success rate was 100% in each group, a p-value could not be calculated.|Farrington-Manning non-inferiority test|||"The percentage of subjects who have a SVC defibrillation impedance between 20 and 100 ohms at the one month post-MRI/waiting period visit in the MRI group is greater than that in the Control group minus 10%.~H0: % successes MRI group ≤ % successes Control group - 10% HA: % successes MRI group \> % successes Control group - 10% Where % successes means the % of subjects whose SVC defibrillation impedance at the one month post-MRI/waiting period visit is between 20 and 100 ohms."||||
72381287|NCT02117414|144271040|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin is 10%.|Difference in percentages|-1.3||||0.006|ONE_SIDED|90.0|-7.0||||Farrington-Manning non-inferiority test|||"The percentage of subjects who experience an APCT increase less than or equal to 0.5V from the pre-MRI/waiting period to one month post-MRI/waiting period in the MRI group is greater than that in the Control group minus 10%.~H0: % successes MRI group ≤ % successes Control group - 10% HA: % successes MRI group \> % successes Control group - 10%"|||-7.0|0.006
72381288|NCT02117414|144271041|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin is 10%.|Difference in percentages|0.3||||0.005|ONE_SIDED|90.0|-6.2|||A priori threshold for statistical significance was 0.05|Farrington-Manning non-inferiority test|||"The percentage of subjects who do not experience a 50% decrease in atrial sensing amplitude from the pre-MRI/waiting period to one month post-MRI/waiting period is greater than that in the Control group minus 10%.~H0: % successes MRI group ≤ % successes Control group - 10% HA: % successes MRI group \> % successes Control group - 10%"|||-6.2|0.005
72381289|NCT02869438|144271051|SUPERIORITY||Mean Difference (Final Values)|0.077||||0.0707|TWO_SIDED|95.0|-0.007|0.161|||Mixed Models Analysis|Model includes covariates of treatment, baseline pre-BD FEV1, region, visit, treatment by visit interaction.|For Day 28|||0.161|-0.007|0.0707
72381290|NCT02869438|144271051|SUPERIORITY||Mean Difference (Final Values)|0.013||||0.7747|TWO_SIDED|95.0|-0.077|0.104|||Mixed Models Analysis|Model includes covariates of treatment, baseline pre-BD FEV1, region, visit, treatment by visit interaction.|For Day 56|||0.104|-0.077|0.7747
72556490|NCT02842853|144644207|EQUIVALENCE|Lot consistency was demonstrated across the 3 lots, if, for each pair of lots and each antigen, the 2-sided 95% CI for the ratio of the GMTs lies between 1/2 and 2.|GMT Ratio|1.07|||||TWO_SIDED|95.0|0.888|1.29||||||Serogroup C: Lot 1 vs Lot 2||1.29|0.888|
72618622|NCT01026038|144768106|SUPERIORITY_OR_OTHER||GMC ratio|2.59|||||TWO_SIDED|95.0|1.8|3.73||||||Serotype 1: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||3.73|1.80|
72381291|NCT02869438|144271051|SUPERIORITY||Mean Difference (Final Values)|0.079||||0.0969|TWO_SIDED|95.0|-0.014|0.173|||Mixed Models Analysis|Model includes covariates of treatment, baseline pre-BD FEV1, region, visit, treatment by visit interaction.|For Day 84|||0.173|-0.014|0.0969
72381292|NCT02869438|144271051|SUPERIORITY||Mean Difference (Final Values)|0.057||||0.1558|TWO_SIDED|95.0|-0.022|0.135|||Mixed Models Analysis|Model includes covariates of treatment, baseline pre-BD FEV1, region, visit, treatment by visit interaction.|For average over Day 28, 56, and 84|||0.135|-0.022|0.1558
72381293|NCT02869438|144271052|SUPERIORITY||Mean Difference (Final Values)|-0.176||||0.2847|TWO_SIDED|95.0|-0.505|0.153|||Mixed Models Analysis|Model includes covariates of treatment, baseline RV, region, visit, treatment by visit interaction.||||0.153|-0.505|0.2847
72381294|NCT02869438|144271053|SUPERIORITY||Mean Difference (Final Values)|-101.0|||<|0.0001|TWO_SIDED|95.0|-118.9|-83.06|||Mixed Models Analysis|Model includes covariates of treatment, baseline eosinophils counts, region, visit, treatment by visit interaction.||||-83.06|-118.9|<0.0001
72381295|NCT02869438|144271054|SUPERIORITY||Mean Difference (Final Values)|0.015||||0.6384|TWO_SIDED|95.0|-0.049|0.08|||Mixed Models Analysis|Model includes covariates of treatment, baseline pre-BD FEV1, region, visit, treatment by visit interaction.|For Day 3|||0.08|-0.049|0.6384
72381296|NCT02869438|144271054|SUPERIORITY||Mean Difference (Final Values)|0.046||||0.148|TWO_SIDED|95.0|-0.016|0.109|||Mixed Models Analysis|Model includes covariates of treatment, baseline pre-BD FEV1, region, visit, treatment by visit interaction.|For Day 7|||0.109|-0.016|0.148
72381297|NCT02869438|144271054|SUPERIORITY||Mean Difference (Final Values)|0.026||||0.4959|TWO_SIDED|95.0|-0.049|0.101|||Mixed Models Analysis|Model includes covariates of treatment, baseline pre-BD FEV1, region, visit, treatment by visit interaction.|For Day 14|||0.101|-0.049|0.4959
72381298|NCT02869438|144271055|SUPERIORITY||Mean Difference (Final Values)|0.006||||0.8667|TWO_SIDED|95.0|-0.062|0.073|||Mixed Models Analysis|Model includes covariates of treatment, baseline pre-BD FVC, region, visit, treatment by visit interaction.|For Day 3|||0.073|-0.062|0.8667
72381299|NCT02869438|144271055|SUPERIORITY||Mean Difference (Final Values)|0.041||||0.2734|TWO_SIDED|95.0|-0.033|0.115|||Mixed Models Analysis|Model includes covariates of treatment, baseline pre-BD FVC, region, visit, treatment by visit interaction.|For Day 7|||0.115|-0.033|0.2734
72381300|NCT02869438|144271055|SUPERIORITY||Mean Difference (Final Values)|0.015||||0.7252|TWO_SIDED|95.0|-0.068|0.098|||Mixed Models Analysis|Model includes covariates of treatment, baseline pre-BD FVC, region, visit, treatment by visit interaction.|For Day 14|||0.098|-0.068|0.7252
72381301|NCT02869438|144271055|SUPERIORITY||Mean Difference (Final Values)|0.075||||0.0976|TWO_SIDED|95.0|-0.014|0.164|||Mixed Models Analysis|Model includes covariates of treatment, baseline pre-BD FVC, region, visit, treatment by visit interaction.|For Day 28|||0.164|-0.014|0.0976
72381302|NCT02869438|144271055|SUPERIORITY||Mean Difference (Final Values)|0.023||||0.6536|TWO_SIDED|95.0|-0.077|0.122|||Mixed Models Analysis|Model includes covariates of treatment, baseline pre-BD FVC, region, visit, treatment by visit interaction.|For Day 56|||0.122|-0.077|0.6536
72381303|NCT02869438|144271055|SUPERIORITY||Mean Difference (Final Values)|0.092||||0.0595|TWO_SIDED|95.0|-0.004|0.188|||Mixed Models Analysis|Model includes covariates of treatment, baseline pre-BD FVC, region, visit, treatment by visit interaction.|For Day 84|||0.188|-0.004|0.0595
72381304|NCT02869438|144271055|SUPERIORITY||Mean Difference (Final Values)|0.063||||0.1377|TWO_SIDED|95.0|-0.02|0.147|||Mixed Models Analysis|Model includes covariates of treatment, baseline pre-BD FVC, region, visit, treatment by visit interaction.|For average of Day 28, 56, 84.|||0.147|-0.02|0.1377
72381305|NCT02869438|144271056|SUPERIORITY||Odds Ratio (OR)|1.49||||0.1604|TWO_SIDED|95.0|0.85|2.58|||Regression, Logistic|Model includes covariates of treatment, baseline pre-BD FEV1, region, visit, treatment by visit interaction.|For Day 3|||2.58|0.85|0.1604
72381306|NCT02869438|144271056|SUPERIORITY||Odds Ratio (OR)|1.29||||0.34|TWO_SIDED|95.0|0.76|2.19|||Regression, Logistic|Model includes covariates of treatment, baseline pre-BD FEV1, region, visit, treatment by visit interaction.|For Day 7|||2.19|0.76|0.3400
72381307|NCT02869438|144271056|SUPERIORITY||Odds Ratio (OR)|1.58||||0.0924|TWO_SIDED|95.0|0.93|2.7|||Regression, Logistic|Model includes covariates of treatment, baseline pre-BD FEV1, region, visit, treatment by visit interaction.|For Day 14|||2.70|0.93|0.0924
72381308|NCT02869438|144271056|SUPERIORITY||Odds Ratio (OR)|1.57||||0.1052|TWO_SIDED|95.0|0.91|2.71|||Regression, Logistic|Model includes covariates of treatment, baseline pre-BD FEV1, region, visit, treatment by visit interaction.|For Day 28|||2.71|0.91|0.1052
72556491|NCT02842853|144644207|EQUIVALENCE|Lot consistency was demonstrated across the 3 lots, if, for each pair of lots and each antigen, the 2-sided 95% CI for the ratio of the GMTs lies between 1/2 and 2.|GMT Ratio|0.866|||||TWO_SIDED|95.0|0.714|1.05||||||Serogroup C: Lot 2 vs Lot 3||1.05|0.714|
72381309|NCT02869438|144271056|SUPERIORITY||Odds Ratio (OR)|1.3||||0.3271|TWO_SIDED|95.0|0.77|2.21|||Regression, Logistic|Model includes covariates of treatment, baseline pre-BD FEV1, region, visit, treatment by visit interaction.|For Day 56|||2.21|0.77|0.3271
72381310|NCT02869438|144271056|SUPERIORITY||Odds Ratio (OR)|1.33||||0.3017|TWO_SIDED|95.0|0.77|2.29|||Regression, Logistic|Model includes covariates of treatment, baseline pre-BD FEV1, region, visit, treatment by visit interaction.|For Day 84|||2.29|0.77|0.3017
72381311|NCT02869438|144271057|SUPERIORITY||Mean Difference (Final Values)|-0.293||||0.0024|TWO_SIDED|95.0|-0.481|-0.105|||Mixed Models Analysis|Model includes covariates of treatment, baseline ACQ-6 score, region, visit, treatment by visit interaction.|For Day 14|||-0.105|-0.481|0.0024
72381312|NCT02869438|144271057|SUPERIORITY||Mean Difference (Final Values)|-0.402||||0.0002|TWO_SIDED|95.0|-0.609|-0.195|||Mixed Models Analysis|Model includes covariates of treatment, baseline ACQ-6 score, region, visit, treatment by visit interaction.|For Day 28|||-0.195|-0.609|0.0002
72381313|NCT02869438|144271057|SUPERIORITY||Mean Difference (Final Values)|-0.312||||0.0117|TWO_SIDED|95.0|-0.554|-0.07|||Mixed Models Analysis|Model includes covariates of treatment, baseline ACQ-6 score, region, visit, treatment by visit interaction.|For Day 56|||-0.07|-0.554|0.0117
72381314|NCT02869438|144271057|SUPERIORITY||Mean Difference (Final Values)|-0.472||||0.0004|TWO_SIDED|95.0|-0.731|-0.213|||Mixed Models Analysis|Model includes covariates of treatment, baseline ACQ-6 score, region, visit, treatment by visit interaction.|For Day 84|||-0.213|-0.731|0.0004
72381315|NCT02869438|144271057|SUPERIORITY||Mean Difference (Final Values)|-0.395||||0.0002|TWO_SIDED|95.0|-0.603|-0.188|||Mixed Models Analysis|Model includes covariates of treatment, baseline ACQ-6 score, region, visit, treatment by visit interaction.|For average of Day 28, 56, 84.|||-0.188|-0.603|0.0002
72381316|NCT02869438|144271058|SUPERIORITY||Mean Difference (Final Values)|-7.229||||0.0001|TWO_SIDED|95.0|-10.832|-3.626|||Mixed Models Analysis|Model includes covariates of treatment, baseline SGRQ score, region, visit, treatment by visit interaction.|For Day 28|||-3.626|-10.832|0.0001
72381317|NCT02869438|144271058|SUPERIORITY||Mean Difference (Final Values)|-5.942||||0.0115|TWO_SIDED|95.0|-10.538|-1.346|||Mixed Models Analysis|Model includes covariates of treatment, baseline SGRQ score, region, visit, treatment by visit interaction.|For Day 56|||-1.346|-10.538|0.0115
72556492|NCT02842853|144644207|EQUIVALENCE|Lot consistency was demonstrated across the 3 lots, if, for each pair of lots and each antigen, the 2-sided 95% CI for the ratio of the GMTs lies between 1/2 and 2.|GMT Ratio|0.927|||||TWO_SIDED|95.0|0.766|1.12||||||Serogroup C: Lot 1 vs Lot 3||1.12|0.766|
72556493|NCT02842853|144644207|EQUIVALENCE|Lot consistency was demonstrated across the 3 lots, if, for each pair of lots and each antigen, the 2-sided 95% CI for the ratio of the GMTs lies between 1/2 and 2.|GMT Ratio|1.02|||||TWO_SIDED|95.0|0.869|1.19||||||Serogroup Y: Lot 1 vs Lot 2||1.19|0.869|
72556494|NCT02842853|144644207|EQUIVALENCE|Lot consistency was demonstrated across the 3 lots, if, for each pair of lots and each antigen, the 2-sided 95% CI for the ratio of the GMTs lies between 1/2 and 2.|GMT Ratio|0.961|||||TWO_SIDED|95.0|0.816|1.13||||||Serogroup Y: Lot 2 vs Lot 3||1.13|0.816|
72556495|NCT02842853|144644207|EQUIVALENCE|Lot consistency was demonstrated across the 3 lots, if, for each pair of lots and each antigen, the 2-sided 95% CI for the ratio of the GMTs lies between 1/2 and 2.|GMT Ratio|0.975|||||TWO_SIDED|95.0|0.829|1.15||||||Serogroup Y: Lot 1 vs Lot 3||1.15|0.829|
72556496|NCT02842853|144644207|EQUIVALENCE|Lot consistency was demonstrated across the 3 lots, if, for each pair of lots and each antigen, the 2-sided 95% CI for the ratio of the GMTs lies between 1/2 and 2.|GMT Ratio|1.04|||||TWO_SIDED|95.0|0.878|1.22||||||Serogroup W: Lot 1 vs Lot 2||1.22|0.878|
72381318|NCT02869438|144271058|SUPERIORITY||Mean Difference (Final Values)|-8.599||||0.0004|TWO_SIDED|95.0|-13.3|-3.898|||Mixed Models Analysis|Model includes covariates of treatment, baseline SGRQ score, region, visit, treatment by visit interaction.|For Day 84|||-3.898|-13.3|0.0004
72381319|NCT02869438|144271058|SUPERIORITY||Mean Difference (Final Values)|-7.257||||0.0003|TWO_SIDED|95.0|-11.133|-3.38|||Mixed Models Analysis|Model includes covariates of treatment, baseline SGRQ score, region, visit, treatment by visit interaction.|For average of Day 28, 56, 84.|||-3.38|-11.133|0.0003
72381320|NCT02869438|144271059|SUPERIORITY||Mean Difference (Final Values)|5.414||||0.2825|TWO_SIDED|95.0|-4.492|15.321|||Mixed Models Analysis|Model includes covariates of treatment, baseline FeNO value, region, visit, treatment by visit interaction.||||15.321|-4.492|0.2825
72381321|NCT02869438|144271069|SUPERIORITY||Mean Difference (Final Values)|-0.365||||0.012|TWO_SIDED|95.0|-0.649|-0.081|||Mixed Models Analysis|Model includes covariates of treatment, baseline PGI-S score, region, visit, treatment by visit interaction.|For Day 84|||-0.081|-0.649|0.0120
72381322|NCT02869438|144271070|SUPERIORITY||Odds Ratio (OR)|2.97||||0.0018|TWO_SIDED|95.0|1.5|5.88|||Regression, Logistic|Model includes covariates of treatment, region.|For Day 84|Responder analysis: responder is defined as Very much improved, improved, and minimally improved.||5.88|1.50|0.0018
72381323|NCT02869438|144271071|SUPERIORITY||Odds Ratio (OR)|2.51||||0.0107|TWO_SIDED|95.0|1.24|5.09|||Regression, Logistic|Model includes covariates of treatment, region.|For Day 84|Responder analysis: responder is defined as Very much improved, improved, and minimally improved.||5.09|1.24|0.0107
72556497|NCT02842853|144644207|EQUIVALENCE|Lot consistency was demonstrated across the 3 lots, if, for each pair of lots and each antigen, the 2-sided 95% CI for the ratio of the GMTs lies between 1/2 and 2.|GMT Ratio|0.936|||||TWO_SIDED|95.0|0.791|1.11||||||Serogroup W: Lot 2 vs Lot 3||1.11|0.791|
72556498|NCT02842853|144644207|EQUIVALENCE|Lot consistency was demonstrated across the 3 lots, if, for each pair of lots and each antigen, the 2-sided 95% CI for the ratio of the GMTs lies between 1/2 and 2.|GMT Ratio|0.97|||||TWO_SIDED|95.0|0.818|1.15||||||Serogroup W: Lot 1 vs Lot 3||1.15|0.818|
72556499|NCT02842853|144644208|NON_INFERIORITY|95% CI of the difference was calculated from the Wilson Score Method without continuity correction. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference is \> -10% for all serogroups.|Percentage Difference|19.1|||||TWO_SIDED|95.0|14.8|23.5||||||Serogroup A||23.5|14.8|
72556500|NCT02842853|144644208|NON_INFERIORITY|95% CI of the difference was calculated from the Wilson Score Method without continuity correction. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference is \> -10% for all serogroups.|Percentage Difference|40.9|||||TWO_SIDED|95.0|36.7|45.0||||||Serogroup C||45|36.7|
72556501|NCT02842853|144644208|NON_INFERIORITY|95% CI of the difference was calculated from the Wilson Score Method without continuity correction. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference is \> -10% for all serogroups.|Percentage Difference|18.1|||||TWO_SIDED|95.0|14.5|21.9||||||Serogroup Y||21.9|14.5|
72556502|NCT02842853|144644208|NON_INFERIORITY|95% CI of the difference was calculated from the Wilson Score Method without continuity correction. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference is \> -10% for all serogroups.|Percentage Difference|19.1|||||TWO_SIDED|95.0|14.9|23.3||||||Serogroup W||23.3|14.9|
72556503|NCT02842853|144644209|NON_INFERIORITY|95% CI of the difference was calculated from the Wilson Score Method without continuity correction. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference is \> -10% for all serogroups.|Percentage Difference|19.6|||||TWO_SIDED|95.0|13.5|25.8||||||Serogroup A||25.8|13.5|
72556504|NCT02842853|144644209|NON_INFERIORITY|95% CI of the difference was calculated from the Wilson Score Method without continuity correction. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference is \> -10% for all serogroups.|Percentage Difference|41.1|||||TWO_SIDED|95.0|35.0|46.9||||||Serogroup C||46.9|35.0|
72556505|NCT02842853|144644209|NON_INFERIORITY|95% CI of the difference was calculated from the Wilson Score Method without continuity correction. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference is \> -10% for all serogroups.|Percentage Difference|27.4|||||TWO_SIDED|95.0|21.7|33.3||||||Serogroup Y||33.3|21.7|
72556506|NCT02842853|144644209|NON_INFERIORITY|95% CI of the difference was calculated from the Wilson Score Method without continuity correction. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference is \> -10% for all serogroups.|Percentage Difference|26.8|||||TWO_SIDED|95.0|20.7|32.9||||||Serogroup W||32.9|20.7|
72556507|NCT02842853|144644210|NON_INFERIORITY|95% CI of the difference was calculated from the Wilson Score Method without continuity correction. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference is \> -10% for all serogroups.|Percentage Difference|18.7|||||TWO_SIDED|95.0|12.5|24.9||||||Serogroup A||24.9|12.5|
72556508|NCT02842853|144644210|NON_INFERIORITY|95% CI of the difference was calculated from the Wilson Score Method without continuity correction. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference is \> -10% for all serogroups.|Percentage Difference|42.3|||||TWO_SIDED|95.0|36.6|48.0||||||Serogroup C||48.0|36.6|
72381328|NCT03475875|144271117|NON_INFERIORITY|A non-inferiority margin of -5 points was used. This margin is based on a 10% shift in the distribution of CLUE scores.|Mean Difference (Final Values)|-4.3|STANDARD_ERROR_OF_MEAN|1.73|||TWO_SIDED|95.0|-7.7|-0.9|||Linear Mixed Model|Kenward and Roger Method was used for the Degrees of Freedom|Mean difference was calculated as Test - Control|It was calculated that 80 participants randomized in a 1:1 fashion between the two sequences would have at least 90% power to detect a 5 points difference in mean overall comfort at the 2-week follow-up. Sample size was determined using Stroup's Method (alpha=0.05).||-0.9|-7.7|
72381329|NCT03475875|144271118|NON_INFERIORITY|A non-inferiority margin of -5 points was used. This margin is based on a 10% shift in the distribution of CLUE scores.|Mean Difference (Final Values)|-1.9|STANDARD_ERROR_OF_MEAN|1.43|||TWO_SIDED|95.0|-4.7|1.0|||Linear Mixed Model|Kenward and Roger Method was used for the Degrees of Freedom|Mean difference was calculated as Test - Control|It was calculated that 80 participants randomized in a 1:1 fashion between the two sequences would have at least 90% power to detect a 5 points difference in mean overall comfort at the 2-week follow-up. Sample size was determined using Stroup's Method (alpha=0.05).||1.0|-4.7|
72381330|NCT00586196|144271130|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.9|||||TWO_SIDED|95.0|0.4|2.3|||GEE|||||2.3|0.4|
72381331|NCT00586196|144271131|SUPERIORITY_OR_OTHER||Effect Size|-0.2|||||TWO_SIDED|95.0|-1.5|1.2|||GEE|||||1.2|-1.5|
72381332|NCT01484054|144271140|NON_INFERIORITY_OR_EQUIVALENCE|A non-inferiority margin of -5 points(CLUE) was used.|Least square mean difference|1.0|STANDARD_ERROR_OF_MEAN|2.117|||TWO_SIDED|95.0|-3.2|5.2|||Mixed Models Analysis|||The alternative hypothesis is that etafilcon A with PVP lenses is non-inferior to etafilcon A control lenses for the Overall Quality of Lens Vision at 7-9 days of follow-up.||5.20|-3.20|
72381333|NCT01484054|144271141|NON_INFERIORITY_OR_EQUIVALENCE|A non-inferiority margin of -5 points(CLUE) was used.|Least square mean difference|4.7|STANDARD_ERROR_OF_MEAN|2.772|||TWO_SIDED|95.0|-0.79|10.19|||Mixed Models Analysis|||The alternative hypothesis is that etafilcon A with PVP lenses is non-inferior to etafilcon A control lenses for the Overall Lens Comfort at 7-9 days of follow-up.||10.19|-0.79|
72381334|NCT01484054|144271142|NON_INFERIORITY_OR_EQUIVALENCE|A non-inferiority margin of -5 points(CLUE) was used.|Least square mean difference|9.44|STANDARD_ERROR_OF_MEAN|1.829|||TWO_SIDED|95.0|5.81|13.07|||Mixed Models Analysis|||Ho: The test lens is non-inferior to the active comparator lens for Handling at 7-9 days follow-up.||13.07|5.81|
72381335|NCT01610271|144271143|SUPERIORITY|ABS was expected to be superior to Control.|Odds Ratio (OR)|0.11|STANDARD_ERROR_OF_MEAN|0.16||0.067|TWO_SIDED|95.0|0.01|2.05||a priori threshold was 0.05|Regression, Logistic|penalized maximum likelihood (Firth) logistic regression, because infection rate was very low (\<3%), as expected|The dispersion is the SE of the OR. ABS was the numerator group, Control was the denominator.|A sample size of 150 per group provided a power of 80% to detect a statistically significant (α≤0.05) 3% difference in SSI rate based on a historical infection rate of 6% in the facility where operations were performed.||2.05|0.01|0.067
72381336|NCT00364130|144271147|SUPERIORITY_OR_OTHER|||||||0.38||||||The outcome is not adjusted for multiple comparisons|Regression, Linear|||||||0.38
72381337|NCT00364130|144271148|SUPERIORITY_OR_OTHER|||||||0.8||||||The outcome is not adjusted for multiple comparisons|Regression, Linear|||||||0.80
72381338|NCT00364130|144271149|SUPERIORITY_OR_OTHER|||||||0.02||||||The outcome is not adjusted for multiple comparisons|Regression, Linear|||||||0.02
72381339|NCT00364130|144271150|SUPERIORITY_OR_OTHER|||||||0.27||||||The outcome was not adjusted for multiple comparisons|Regression, Linear|||||||0.27
72381340|NCT00364130|144271151|SUPERIORITY_OR_OTHER|||||||0.84||||||The outcome is not adjusted for multiple comparisons|Regression, Linear|||||||0.84
72381341|NCT00364130|144271152|SUPERIORITY_OR_OTHER|||||||0.66||||||The outcome is not adjusted for multiple comparisons|Regression, Linear|||||||0.66
72381342|NCT00364130|144271153|SUPERIORITY_OR_OTHER|||||||0.7||||||The outcome is not adjusted for multiple comparisons|Regression, Linear|||||||0.70
72381343|NCT00364130|144271154|SUPERIORITY_OR_OTHER|||||||0.98||||||Outcome is not adjusted for multiple comparisons|Regression, Linear|||||||0.98
72381344|NCT00410202|144271175|SUPERIORITY_OR_OTHER||Difference Estimate|8.9||||0.1336|TWO_SIDED|95.0|-2.0|19.9|||Hochberg procedure|||||19.9|-2.0|0.1336
72381345|NCT00410202|144271175|SUPERIORITY_OR_OTHER||Difference Estimate|5.7||||0.2619|TWO_SIDED|95.0|-4.2|15.5|||Hochberg procedure|||||15.5|-4.2|0.2619
72381346|NCT00410202|144271176|SUPERIORITY_OR_OTHER||Difference estimate|15.0||||0.0095|TWO_SIDED|95.0|3.7|26.4|||Hochberg procedure|||||26.4|3.7|0.0095
72381347|NCT00410202|144271177|SUPERIORITY_OR_OTHER||Difference Estimate|11.8|||||TWO_SIDED|95.0|2.5|21.1||||||||21.1|2.5|
72381348|NCT00410202|144271177|SUPERIORITY_OR_OTHER||Difference Estimate|8.6|||||TWO_SIDED|95.0|-1.1|18.2||||||||18.2|-1.1|
72381349|NCT00410202|144271178|SUPERIORITY_OR_OTHER||Difference estimate|12.9|||||TWO_SIDED|95.0|1.8|23.9||||||||23.9|1.8|
72381350|NCT00410202|144271179|SUPERIORITY_OR_OTHER||Difference Estimate|8.9|||||TWO_SIDED|95.0|0.3|17.4||||||||17.4|0.3|
72381351|NCT00410202|144271179|SUPERIORITY_OR_OTHER||Difference Estimate|8.6|||||TWO_SIDED|95.0|-0.1|17.3||||||||17.3|-0.1|
72381352|NCT00410202|144271180|SUPERIORITY_OR_OTHER||Difference estimate|12.9|||||TWO_SIDED|95.0|2.4|23.4||||||||23.4|2.4|
72381353|NCT00410202|144271183|SUPERIORITY_OR_OTHER||Difference Estimate|-1.26|||||TWO_SIDED|95.0|-1.534|-0.994|||Regression, Linear|||||-0.994|-1.534|
72381354|NCT00410202|144271183|SUPERIORITY_OR_OTHER||Difference Estimate|-0.55|||||TWO_SIDED|95.0|-0.824|-0.281|||Regression, Linear|||||-0.281|-0.824|
72381355|NCT00410202|144271185|SUPERIORITY_OR_OTHER||Difference Estimate|-2.4|||||TWO_SIDED|95.0|-15.5|10.7||||||||10.7|-15.5|
72381356|NCT00410202|144271185|SUPERIORITY_OR_OTHER||Difference Estimate|-1.2|||||TWO_SIDED|95.0|-15.0|12.6||||||||12.6|-15.0|
72381357|NCT00410202|144271186|SUPERIORITY_OR_OTHER||Difference Estimate|-2.8|||||TWO_SIDED|95.0|-16.2|10.6||||||||10.6|-16.2|
72381358|NCT00410202|144271187|SUPERIORITY_OR_OTHER||Difference Estimate|0.8|||||TWO_SIDED|95.0|-5.2|6.7||||||||6.7|-5.2|
72381359|NCT00410202|144271187|SUPERIORITY_OR_OTHER||Difference Estimate|1.3|||||TWO_SIDED|95.0|-4.6|7.2||||||||7.2|-4.6|
72381360|NCT00410202|144271188|SUPERIORITY_OR_OTHER||Difference Estimate|-1.5|||||TWO_SIDED|95.0|-9.5|6.4||||||||6.4|-9.5|
72381361|NCT00410202|144271189|SUPERIORITY_OR_OTHER||Difference Estimate|2.2|||||TWO_SIDED|95.0|-2.4|6.8||||||||6.8|-2.4|
72381362|NCT00410202|144271189|SUPERIORITY_OR_OTHER||Difference Estimate|1.4|||||TWO_SIDED|95.0|-3.5|6.2||||||||6.2|-3.5|
72381363|NCT00410202|144271190|SUPERIORITY_OR_OTHER||Difference Estimate|2.1|||||TWO_SIDED|95.0|-3.6|7.8||||||||7.8|-3.6|
72381364|NCT00410202|144271191|SUPERIORITY_OR_OTHER||Difference Estimate|0.7|||||TWO_SIDED|95.0|-0.7|2.1||||||||2.1|-0.7|
72381365|NCT00410202|144271191|SUPERIORITY_OR_OTHER||Difference Estimate|0.0|||||TWO_SIDED|95.0|-2.0|2.0||||||||2.0|-2.0|
72381366|NCT00410202|144271193|SUPERIORITY_OR_OTHER||Difference Estimate|0.7|||||TWO_SIDED|95.0|-0.7|2.1||||||||2.1|-0.7|
72433659|NCT00991276|144380394|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|14.17|STANDARD_ERROR_OF_MEAN|4.0||0.0006|TWO_SIDED|95.0|6.25|22.08||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||Adequacy: P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||22.08|6.25|0.0006
72381367|NCT00410202|144271193|SUPERIORITY_OR_OTHER||Difference Estimate|0.7|||||TWO_SIDED|95.0|-0.7|2.1||||||||2.1|-0.7|
72381368|NCT00144027|144271210|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|7.57||||0.03|TWO_SIDED|95.0|1.21|47.53|||Regression, Logistic|logistic regression predicting 6-month adherence, controling for baseline depression, extrapyramidal side effects, and baseline adherence.||||47.53|1.21|0.03
72381369|NCT00395538|144271217|OTHER|A contrast statement within the mixed models analysis tested for differences in the cn.BV/TV between the baseline and the year 1 biopsy.||||||0.015||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Cn.BV/TV at biopsy baseline, year 1, 2 \& 4 combined as the dependent variable; biopsy year as the independent variable, covariate for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2. No bone biopsy baseline covariate was included because it would over-parameterize the model.||||0.015
72381370|NCT00395538|144271217|OTHER|A contrast statement within the mixed models analysis tested for differences in the cn.BV/TV between the baseline and the years 2 and 4 (combined) biopsy.||||||0.002||||||No adjustments were made for multiple comparisons, because the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Cn.BV/TV at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2. No bone biopsy baseline covariate included because it would over-parameterize the model.||||0.002
72381371|NCT00395538|144271217|EQUIVALENCE|A contrast statement within the mixed models analysis tested for differences in the cn.BV/TV between the year 1 biopsy and the years 2 and 4 (combined) biopsy.||||||0.649||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis was performed with: Cn.BV/TV change from baseline at biopsy year 1 or years 2 and 4 combined as the dependent variable; biopsy year, and baseline Cn.BV/TV, as model covariates; and a random effect for participant. Since Cohort 2 had a time delay of 30 to 31 months from the baseline biopsy to start of HPTH therapy, this time delay (centered to stabilize variance) was added as a covariate to the model for Cohort 2 only (using a Cohort 2 indicator variable).||||0.649
72381372|NCT00395538|144271218|OTHER|A contrast statement within the mixed models analysis tested for differences in the Ct.Po.N between the baseline and the year 1 biopsy. P-value interpretation is questionable since there were only 4 participants with non-missing Ct.Po.N values for both their baseline and year 1 biopsies.||||||0.371||||||No adjustments were made for multiple comparisons, because the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ct.Po.N at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.371
72381373|NCT00395538|144271218|OTHER|A contrast statement within the mixed models analysis tested for differences in the Ct.Po.N between the baseline and the years 2 and 4 (combined) biopsy.||||||0.129||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis was performed with: Ct.Po.N change from baseline at biopsy year 1 or years 2 and 4 combined as the dependent variable; biopsy year, and baseline Ct.Po.N, as model covariates; and a random effect for participant. Since Cohort 2 had a time delay of 30 to 31 months from the baseline biopsy to start of HPTH therapy, this time delay (centered to stabilize variance) was added as a covariate to the model for Cohort 2 only (using a Cohort 2 indicator variable).||||0.129
72381374|NCT00395538|144271218|EQUIVALENCE|A contrast statement within the mixed models analysis tested for differences in the Ct.Po.N between the year 1 biopsy and the years 2 and 4 (combined) biopsy.||||||0.538||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ct.Po.N at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.538
72381375|NCT00395538|144271219|OTHER|A contrast statement within the mixed models analysis tested for differences in the Cn.BFR/BS between the baseline and the year 1 biopsy.||||||0.009||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|A baseline covariate not added to model since it would over-parameterize the model.||Mixed models analysis: Cn.BFR/BS at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.009
72381376|NCT00395538|144271219|OTHER|A contrast statement within the mixed models analysis tested for differences in the Cn.BFR/BS between the baseline and the years 2 and 4 (combined) biopsy.|||||<|0.001||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Cn.BFR/BS at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||<0.001
72381377|NCT00395538|144271219|EQUIVALENCE|A contrast statement within the mixed models analysis tested for differences in the Cn.BFR/BS between the year 1 biopsy and the years 2 and 4 (combined) biopsy.||||||0.374||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Cn.BFR/BS at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.374
72381378|NCT00395538|144271220|OTHER|A contrast statement within the mixed models analysis tested for differences in the Cn.MS/BS between the baseline and the year 1 biopsy.||||||0.002||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Cn.MS/BS at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.002
72381379|NCT00395538|144271220|OTHER|A contrast statement within the mixed models analysis tested for differences in the Cn.MS/BS between the baseline and the years 2 and 4 (combined) biopsy.|||||<|0.001||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Cn.MS/BS at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||<0.001
72381380|NCT00395538|144271220|EQUIVALENCE|A contrast statement within the mixed models analysis tested for differences in the Cn.MS/BS between the year 1 biopsy and the years 2 and 4 (combined) biopsy.||||||0.168||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Cn.MS/BS at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.168
72381381|NCT00395538|144271221|OTHER|A contrast statement within the mixed models analysis tested for differences in the Ec.BFR/BS between the baseline and the year 1 biopsy. P-value interpretation is questionable since there were only 4 participants with non-missing Ec.BFR/BS values for both their baseline and year 1 biopsies.||||||0.083||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ec.BFR/BS at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.083
72433660|NCT00991276|144380394|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|11.07|STANDARD_ERROR_OF_MEAN|3.97||0.0061|TWO_SIDED|95.0|3.22|18.92||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||Adequacy: P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||18.92|3.22|0.0061
72381382|NCT00395538|144271221|OTHER|A contrast statement within the mixed models analysis tested for differences in the Ec.BFR/BS between the baseline and the years 2 and 4 (combined) biopsy.||||||0.001||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ec.BFR/BS at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.001
72381383|NCT00395538|144271221|EQUIVALENCE|A contrast statement within the mixed models analysis tested for differences in the Ec.BFR/BS between the year 1 biopsy and the years 2 and 4 (combined) biopsy.||||||0.164||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ec.BFR/BS at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.164
72381384|NCT00395538|144271222|OTHER|A contrast statement within the mixed models analysis tested for differences in the Ec.MS/BS between the baseline and the year 1 biopsy. P-value interpretation is questionable since there were only 4 participants with non-missing Ec.MS/BS values for both their baseline and year 1 biopsies.||||||0.031||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ec.MS/BS at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.031
72381385|NCT00395538|144271222|OTHER|A contrast statement within the mixed models analysis tested for differences in the Ec.MS/BS between the baseline and the years 2 and 4 (combined) biopsy.||||||0.001||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ec.MS/BS at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.001
72381386|NCT00395538|144271222|EQUIVALENCE|A contrast statement within the mixed models analysis tested for differences in the Ec.MS/BS between the year 1 biopsy and the years 2 and 4 (combined) biopsy.||||||0.178||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ec.MS/BS at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.178
72395129|NCT02289690|144296700|SUPERIORITY||Hazard Ratio (HR)|0.979||||0.924|TWO_SIDED|80.0|0.744|1.288|||Log Rank|Two-sided log-rank test stratified by lactate dehydrogenase (LDH) level|Hazard ratio estimate was obtained from a Cox proportional hazards model stratified by LDH level. A hazard ratio of \< 1 favors veliparib in combination with carboplatin and etoposide followed by placebo maintenance monotherapy (Arm B).|"If the primary analysis of PFS (Arm A vs Arm C) was statistically significant a fixed sequence testing procedure was to be performed with a 2-sided significance level of 0.2 for the following key secondary endpoints:~1. OS (Arm A vs Arm C)~2. PFS (Arms B vs Arm C)~3. OS (Arm B vs Arm C)~4. ORR (Arm A vs Arm C)~5. ORR (Arm B vs Arm C)~If significance versus Arm C was not demonstrated, all endpoints later in the testing hierarchy were to be considered exploratory."||1.288|0.744|0.924
72433661|NCT00991276|144380394|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|3.1|STANDARD_ERROR_OF_MEAN|3.95||0.4342|TWO_SIDED|95.0|-4.72|10.93||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||Adequacy: P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||10.93|-4.72|0.4342
72433662|NCT00991276|144380394|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-2.43|STANDARD_ERROR_OF_MEAN|2.07||0.242|TWO_SIDED|95.0|-6.53|1.66||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||Somnolence: P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||1.66|-6.53|0.2420
72381387|NCT00395538|144271223|OTHER|A contrast statement within the mixed models analysis tested for differences in the Ic.BFR/BS between the baseline and the year 1 biopsy. P-value interpretation is questionable since there were only 4 participants with non-missing Ic.BFR/BS values for both their baseline and year 1 biopsies.||||||0.001||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ic.BFR/BS at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.001
72381388|NCT00395538|144271223|OTHER|A contrast statement within the mixed models analysis tested for differences in the Ic.BFR/BS between the baseline and the years 2 and 4 (combined) biopsy.||||||0.022||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ic.BFR/BS at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.022
72381389|NCT00395538|144271223|EQUIVALENCE|A contrast statement within the mixed models analysis tested for differences in the Ic.BFR/BS between the year 1 biopsy and the years 2 and 4 (combined) biopsy.||||||0.172||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ic.BFR/BS at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.172
72381390|NCT00395538|144271224|OTHER|A contrast statement within the mixed models analysis tested for differences in the Ic.MS/BS between the baseline and the year 1 biopsy. P-value interpretation is questionable since there were only 4 participants with non-missing Ic.MS/BS values for both their baseline and year 1 biopsies.||||||0.001||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ic.MS/BS at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.001
72381391|NCT00395538|144271224|OTHER|A contrast statement within the mixed models analysis tested for differences in the Ic.MS/BS between the baseline and the years 2 and 4 (combined) biopsy.||||||0.018||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ic.MS/BS at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.018
72381392|NCT00395538|144271224|EQUIVALENCE|A contrast statement within the mixed models analysis tested for differences in the Ic.MS/BS between the year 1 biopsy and the years 2 and 4 (combined) biopsy.||||||0.155||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ic.MS/BS at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.155
72381393|NCT00395538|144271225|OTHER|A contrast statement within the mixed models analysis tested for differences in the Tb.Th between the baseline and the year 1 biopsy.||||||0.72||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Tb.Th at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.720
72433663|NCT00991276|144380394|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|2.05||0.981|TWO_SIDED|95.0|-4.12|4.02||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||Somnolence: P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||4.02|-4.12|0.9810
72556509|NCT02842853|144644210|NON_INFERIORITY|95% CI of the difference was calculated from the Wilson Score Method without continuity correction. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference is \> -10% for all serogroups.|Percentage Difference|10.0|||||TWO_SIDED|95.0|6.18|14.5||||||Serogroup Y||14.5|6.18|
72381394|NCT00395538|144271225|OTHER|A contrast statement within the mixed models analysis tested for differences in the Tb.Th between the baseline and the years 2 and 4 (combined) biopsy.||||||0.944||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Tb.Th at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.944
72381395|NCT00395538|144271225|OTHER|A contrast statement within the mixed models analysis tested for differences in the Tb.Th between the year 1 biopsy and the years 2 and 4 (combined) biopsy.||||||0.73||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Tb.Th at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.730
72381396|NCT00395538|144271226|OTHER|A contrast statement within the mixed models analysis tested for differences in the Tb.N between the baseline and the year 1 biopsy.||||||0.019||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis was performed with: Tb.N change from baseline at biopsy year 1 or years 2 and 4 combined as the dependent variable; biopsy year, and baseline Tb.N, as model covariates; and a random effect for participant. Since Cohort 2 had a time delay of 30 to 31 months from the baseline biopsy to start of HPTH therapy, this time delay (centered to stabilize variance) was added as a covariate to the model for Cohort 2 only (using a Cohort 2 indicator variable).||||0.019
72381397|NCT00395538|144271226|OTHER|A contrast statement within the mixed models analysis tested for differences in the Tb.N between the baseline and the years 2 and 4 (combined) biopsy.||||||0.017||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis was performed with: Tb.N change from baseline at biopsy year 1 or years 2 and 4 combined as the dependent variable; biopsy year, and baseline Tb.N, as model covariates; and a random effect for participant. Since Cohort 2 had a time delay of 30 to 31 months from the baseline biopsy to start of HPTH therapy, this time delay (centered to stabilize variance) was added as a covariate to the model for Cohort 2 only (using a Cohort 2 indicator variable).||||0.017
72381398|NCT00395538|144271226|OTHER|A contrast statement within the mixed models analysis tested for differences in the Tb.N between the year 1 biopsy and the years 2 and 4 (combined) biopsy.||||||0.843||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis was performed with: Tb.N change from baseline at biopsy year 1 or years 2 and 4 combined as the dependent variable; biopsy year, and baseline Tb.N, as model covariates; and a random effect for participant. Since Cohort 2 had a time delay of 30 to 31 months from the baseline biopsy to start of HPTH therapy, this time delay (centered to stabilize variance) was added as a covariate to the model for Cohort 2 only (using a Cohort 2 indicator variable).||||0.843
72381399|NCT00395538|144271227|OTHER|A contrast statement within the mixed models analysis tested for differences in the Tb.Sp between the baseline and the year 1 biopsy.||||||0.013||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Tb.Sp at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.013
72381400|NCT00395538|144271227|OTHER|A contrast statement within the mixed models analysis tested for differences in the Tb.Sp between the baseline and the years 2 and 4 (combined) biopsy.||||||0.025||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Tb.Sp at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.025
72618623|NCT01026038|144768106|SUPERIORITY_OR_OTHER||GMC ratio|1.26|||||TWO_SIDED|95.0|0.88|1.79||||||Serotype 1: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.79|0.88|
72381401|NCT00395538|144271227|OTHER|A contrast statement within the mixed models analysis tested for differences in the Tb.Sp between the year 1 biopsy and the years 2 and 4 (combined) biopsy.||||||0.608||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Tb.Sp at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.608
72381402|NCT00395538|144271228|OTHER|A contrast statement within the mixed models analysis tested for differences in the Ct.Th between the baseline and the year 1 biopsy. P-value interpretation is questionable since there were only 4 participants with non-missing Ct.Th values for both their baseline and year 1 biopsies.||||||0.043||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ct.Th at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.043
72381403|NCT00395538|144271228|OTHER|A contrast statement within the mixed models analysis tested for differences in the Ct.Th between the baseline and the years 2 and 4 (combined) biopsy.||||||0.334||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ct.Th at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.334
72381404|NCT00395538|144271228|OTHER|A contrast statement within the mixed models analysis tested for differences in the Ct.Th between the year 1 biopsy and the years 2 and 4 (combined) biopsy.||||||0.269||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis was performed with: Ct.Th change from baseline at biopsy year 1 or years 2 and 4 combined as the dependent variable; biopsy year, and baseline Ct.Th, as model covariates; and a random effect for participant. Since Cohort 2 had a time delay of 30 to 31 months from the baseline biopsy to start of HPTH therapy, this time delay (centered to stabilize variance) was added as a covariate to the model for Cohort 2 only (using a Cohort 2 indicator variable).||||0.269
72381405|NCT00395538|144271229|OTHER|A contrast statement within the mixed models analysis tested for differences in the Ct.Ar between the baseline and the year 1 biopsy. P-value interpretation is questionable since there were only 4 participants with non-missing Ct.Ar values for both their baseline and year 1 biopsies.||||||0.358||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ct.Ar at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.358
72381406|NCT00395538|144271229|OTHER|A contrast statement within the mixed models analysis tested for differences in the Ct.Ar between the baseline and the years 2 and 4 (combined) biopsy.||||||0.76||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ct.Ar at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.760
72381407|NCT00395538|144271229|OTHER|A contrast statement within the mixed models analysis tested for differences in the Ct.Ar between the year 1 biopsy and the years 2 and 4 (combined) biopsy.||||||0.57||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ct.Ar at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.570
72395130|NCT02289690|144296701|SUPERIORITY||Hazard Ratio (HR)|1.432||||0.088|TWO_SIDED|80.0|1.092|1.879|||Log Rank|Two-sided log rank test stratified by LDH level.|Hazard ratio estimate was obtained from a Cox proportional hazards model stratified by LDH level. A hazard ratio of \< 1 favors veliparib in combination with carboplatin and etoposide followed by veliparib maintenance monotherapy (Arm A).|"If the primary analysis of PFS (Arm A vs Arm C) was statistically significant a fixed sequence testing procedure was to be performed with a 2-sided significance level of 0.2 for the following key secondary endpoints:~1. OS (Arm A vs Arm C)~2. PFS (Arms B vs Arm C)~3. OS (Arm B vs Arm C)~4. ORR (Arm A vs Arm C)~5. ORR (Arm B vs Arm C)~If significance versus Arm C was not demonstrated, all endpoints later in the testing hierarchy were to be considered exploratory."||1.879|1.092|0.088
72556510|NCT02842853|144644210|NON_INFERIORITY|95% CI of the difference was calculated from the Wilson Score Method without continuity correction. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference is \> -10% for all serogroups.|Percentage Difference|12.5|||||TWO_SIDED|95.0|7.22|18.2||||||Serogroup W||18.2|7.22|
72556511|NCT02842853|144644211|OTHER||Percentage Difference|-5.4|||||TWO_SIDED|95.0|-9.59|-1.16||||||Serogroup A: Lot 1 vs Lot 2||-1.16|-9.59|
72556512|NCT02842853|144644211|OTHER||Percentage Difference|2.9|||||TWO_SIDED|95.0|-1.3|7.01||||||Serogroup A: Lot 2 vs Lot 3||7.01|-1.3|
72556513|NCT02842853|144644211|OTHER||Percentage Difference|-2.5|||||TWO_SIDED|95.0|-6.78|1.74||||||Serogroup A: Lot 1 vs Lot 3||1.74|-6.78|
72556514|NCT02842853|144644211|OTHER||Percentage Difference|1.3|||||TWO_SIDED|95.0|-1.58|4.28||||||Serogroup C: Lot 1 vs Lot 2||4.28|-1.58|
72556515|NCT02842853|144644211|OTHER||Percentage Difference|2.4|||||TWO_SIDED|95.0|-0.74|5.54||||||Serogroup C: Lot 2 vs Lot 3||5.54|-0.740|
72556516|NCT02842853|144644211|OTHER||Percentage Difference|3.7|||||TWO_SIDED|95.0|0.708|6.79||||||Serogroup C: Lot 1 vs Lot 3||6.79|0.708|
72556517|NCT02842853|144644211|OTHER||Percentage Difference|0.5|||||TWO_SIDED|95.0|-2.14|3.07||||||Serogroup Y: Lot 1 vs Lot 2||3.07|-2.14|
72381408|NCT00395538|144271230|OTHER|A contrast statement within the mixed models analysis tested for differences in the Ct.Po.Ar between the baseline and the year 1 biopsy. P-value interpretation is questionable since there were only 4 participants with non-missing Ct.Po.Ar values for both their baseline and year 1 biopsies.||||||0.166||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ct.Po.Ar at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.166
72381409|NCT00395538|144271230|OTHER|A contrast statement within the mixed models analysis tested for differences in the Ct.Po.Ar between the baseline and the years 2 and 4 (combined) biopsy.||||||0.895||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ct.Po.Ar at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.895
72381410|NCT00395538|144271230|OTHER|A contrast statement within the mixed models analysis tested for differences in the Ct.Po.Ar between the year 1 biopsy and the years 2 and 4 (combined) biopsy.||||||0.282||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ct.Po.Ar at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.282
72433664|NCT00991276|144380394|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-2.38|STANDARD_ERROR_OF_MEAN|2.05||0.2468|TWO_SIDED|95.0|-6.44|1.67||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||Somnolence: P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||1.67|-6.44|0.2468
72433665|NCT00991276|144380394|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.46|STANDARD_ERROR_OF_MEAN|0.32||0.1496|TWO_SIDED|95.0|-0.17|1.09||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||Sleep Quantity: P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||1.09|-0.17|0.1496
72618624|NCT01026038|144768106|SUPERIORITY_OR_OTHER||GMC ratio|0.49|||||TWO_SIDED|95.0|0.32|0.74||||||Serotype 1: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||0.74|0.32|
72433666|NCT00991276|144380394|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.31||0.8184|TWO_SIDED|95.0|-0.69|0.55||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||Sleep Quantity: P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||0.55|-0.69|0.8184
72556518|NCT02842853|144644211|OTHER||Percentage Difference|2.0|||||TWO_SIDED|95.0|-0.763|4.79||||||Serogroup Y: Lot 2 vs Lot 3||4.79|-0.763|
72556519|NCT02842853|144644211|OTHER||Percentage Difference|2.5|||||TWO_SIDED|95.0|-0.248|5.2||||||Serogroup Y: Lot 1 vs Lot 3||5.20|-0.248|
72556520|NCT02842853|144644211|OTHER||Percentage Difference|0.8|||||TWO_SIDED|95.0|-3.0|4.54||||||Serogroup W: Lot 1 vs Lot 2||4.54|-3.00|
72556521|NCT02842853|144644211|OTHER||Percentage Difference|2.0|||||TWO_SIDED|95.0|-1.84|5.89||||||Serogroup W: Lot 2 vs Lot 3||5.89|-1.84|
72556522|NCT02842853|144644211|OTHER||Percentage Difference|2.8|||||TWO_SIDED|95.0|-1.02|6.61||||||Serogroup W: Lot 1 vs Lot 3||6.61|-1.02|
72556523|NCT02842853|144644212|OTHER||GMT Ratio|1.93|||||TWO_SIDED|95.0|1.67|2.24||||||Serogroup A||2.24|1.67|
72556524|NCT02842853|144644212|OTHER||GMT Ratio|8.05|||||TWO_SIDED|95.0|6.58|9.84||||||Serogroup C||9.84|6.58|
72556525|NCT02842853|144644212|OTHER||GMT Ratio|3.22|||||TWO_SIDED|95.0|2.71|3.84||||||Serogroup Y||3.84|2.71|
72556526|NCT02842853|144644212|OTHER||GMT Ratio|1.9|||||TWO_SIDED|95.0|1.61|2.24||||||Serogroup W||2.24|1.61|
72556527|NCT03317444|144644235|SUPERIORITY||Treatment difference in % of subjects|36.7|||<|0.0001|TWO_SIDED|95.0|23.5|48.9|||Fisher Exact|||% Subjects Who Met Endpoint (≥ 4 mEq/L Change from Baseline Serum Bicarbonate or Serum Bicarbonate in the Normal Range \[22 - 29 mEq/L\]): TRC101-Placebo||48.9|23.5|< 0.0001
72556528|NCT03317444|144644235|SUPERIORITY||Treatment difference in % of subjects|34.5|||<|0.0001|TWO_SIDED|95.0|21.2|46.8|||Fisher Exact|||% Subjects with ≥ 4 mEq/L Change from Baseline in Serum Bicarbonate: TRC101-Placebo||46.8|21.2|< 0.0001
72556529|NCT03317444|144644235|SUPERIORITY||Treatment difference in % of subjects|33.1|||<|0.0001|TWO_SIDED|95.0|19.7|45.6|||Fisher Exact|||% Subjects with Serum Bicarbonate in the Normal Range (22 - 29 mEq/L): TRC101-Placebo||45.6|19.7|< 0.0001
72433667|NCT00991276|144380394|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.53|STANDARD_ERROR_OF_MEAN|0.31||0.0918|TWO_SIDED|95.0|-0.09|1.15||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||Sleep Quantity: P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||1.15|-0.09|0.0918
72433668|NCT00991276|144380394|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-9.89|STANDARD_ERROR_OF_MEAN|2.48||0.0001|TWO_SIDED|95.0|-14.8|-4.99||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||6-Item Sleep Problems Index: P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||-4.99|-14.80|0.0001
72433669|NCT00991276|144380394|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-6.54|STANDARD_ERROR_OF_MEAN|2.46||0.0089|TWO_SIDED|95.0|-11.42|-1.67||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||6-Item Sleep Problems Index: P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||-1.67|-11.42|0.0089
72433670|NCT00991276|144380394|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-3.35|STANDARD_ERROR_OF_MEAN|2.45||0.1746|TWO_SIDED|95.0|-8.21|1.51||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||6-Item Sleep Problems Index: P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||1.51|-8.21|0.1746
72433671|NCT00991276|144380394|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-10.14|STANDARD_ERROR_OF_MEAN|2.44|<|0.0001|TWO_SIDED|95.0|-14.96|-5.32||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||9-Item Sleep Problems Index: P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||-5.32|-14.96|<0.0001
72433672|NCT00991276|144380394|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-5.13|STANDARD_ERROR_OF_MEAN|2.42||0.0359|TWO_SIDED|95.0|-9.91|-0.34||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||9-Item Sleep Problems Index: P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||-0.34|-9.91|0.0359
72433673|NCT00991276|144380394|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-5.01|STANDARD_ERROR_OF_MEAN|2.41||0.0395|TWO_SIDED|95.0|-9.78|-0.24||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||9-Item Sleep Problems Index: P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||-0.24|-9.78|0.0395
72433674|NCT00991276|144380394|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.14|STANDARD_ERROR_OF_MEAN|0.06||0.0278|TWO_SIDED|95.0|0.02|0.27||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||Optimal Sleep: P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||0.27|0.02|0.0278
72433675|NCT00991276|144380394|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.08|STANDARD_ERROR_OF_MEAN|0.06||0.2||95.0|-0.04|0.2||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||Optimal Sleep: P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||0.20|-0.04|0.2000
72433676|NCT00991276|144380394|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.06|STANDARD_ERROR_OF_MEAN|0.06||0.3396|TWO_SIDED|95.0|-0.06|0.18||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||Optimal Sleep: P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||0.18|-0.06|0.3396
72556530|NCT03317444|144644236|SUPERIORITY||Treatment difference in LS means|2.63|STANDARD_ERROR_OF_MEAN|0.44|<|0.0001|TWO_SIDED|95.0|1.77|3.5|||Mixed-effect repeated measures model||Standard error presented above is for the LS mean.|Least Squares (LS) Mean Change from Baseline: TRC101-Placebo||3.5|1.77|< 0.0001
72556531|NCT02944617|144644238|OTHER|||||||1|||||||Fisher Exact|||||||1.00
72556532|NCT02944617|144644240|OTHER|||||||0.077|||||||Log Rank|||||||0.077
72433677|NCT00991276|144380394|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-14.56|STANDARD_ERROR_OF_MEAN|3.22|<|0.0001|TWO_SIDED|95.0|-20.93|-8.19||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||Sleep Disturbance: P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||-8.19|-20.93|<0.0001
72433678|NCT00991276|144380394|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-6.11|STANDARD_ERROR_OF_MEAN|3.2||0.0584|TWO_SIDED|95.0|-12.43|0.22||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||Sleep Disturbance: P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||0.22|-12.43|0.0584
72433679|NCT00991276|144380394|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-8.45|STANDARD_ERROR_OF_MEAN|3.19||0.009|TWO_SIDED|95.0|-14.76|-2.15||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||Sleep Disturbance: P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||-2.15|-14.76|0.0090
72433680|NCT00991276|144380394|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-2.69|STANDARD_ERROR_OF_MEAN|2.28||0.2405|TWO_SIDED|95.0|-7.2|1.82||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||Snoring: P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||1.82|-7.20|0.2405
72433681|NCT00991276|144380394|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|2.26||0.7565|TWO_SIDED|95.0|-5.18|3.77||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||Snoring: P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||3.77|-5.18|0.7565
72433682|NCT00991276|144380394|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.98|STANDARD_ERROR_OF_MEAN|2.25||0.3792|TWO_SIDED|95.0|-6.43|2.47||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||Snoring: P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||2.47|-6.43|0.3792
72433683|NCT00991276|144380395|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|5.27|STANDARD_ERROR_OF_MEAN|1.66||0.0019|TWO_SIDED|95.0|1.98|8.55||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||8.55|1.98|0.0019
72433684|NCT00991276|144380395|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|3.25|STANDARD_ERROR_OF_MEAN|1.65||0.0506|TWO_SIDED|95.0|-0.01|6.51||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||6.51|-0.01|0.0506
72433685|NCT00991276|144380395|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|2.01|STANDARD_ERROR_OF_MEAN|1.64||0.2222|TWO_SIDED|95.0|-1.24|5.26||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||5.26|-1.24|0.2222
72433686|NCT00711646|144380397|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-0.517||||0.048|TWO_SIDED|95.0|-1.029|-0.004|||ANCOVA|||The change in mean 11-point Numerical Rating Scale spasticity score was compared between treatment groups using analysis of covariance (ANCOVA). The model included treatment and centre as factors and baseline 11-point Numerical Rating Scale spasticity score as a covariate.||-0.004|-1.029|0.048
72493948|NCT01562548|144516794|SUPERIORITY_OR_OTHER||Least Squares Means Difference|-0.21||||0.68|TWO_SIDED|95.0|-1.23|0.8||P-value was associated with t-test for difference of LS means|t-test, 2 sided|The model included factors for treatment (as a fixed effect) and site (as a random effect).|Least Square mean from Mixed Model including factors for treatment (as a fixed effect) and site (as a random effect). Difference was First named treatment - second named treatment|Null hypotheses was tested as: H01: There was no difference in the mean change from baseline of muscle spasm score between Guaifenesin 600mg and placebo. H02: There was no difference in the mean change from baseline of muscle spasm score between Guaifenesin 1200mg and placebo. H03: There was no difference in the mean change from baseline of muscle spasm score between Guaifenesin 1200mg and Guaifenesin 600mg.||0.80|-1.23|0.68
72433687|NCT00711646|144380398|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-0.11||||0.218|TWO_SIDED|95.0|-0.29|0.07|||ANCOVA|||The change in mean Ashworth Scale score was compared between treatment groups using ANCOVA. The model included treatment and centre as factors and baseline Ashworth Scale score as a covariate.||0.07|-0.29|0.218
72433688|NCT00711646|144380399|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-0.17||||0.141|TWO_SIDED|95.0|-0.39|0.06|||ANCOVA|||The change in mean spasm frequency score was compared between treatment groups using ANCOVA. The model included treatment and centre as factors and baseline spasm frequency score as a covariate.||0.06|-0.39|0.141
72433689|NCT00711646|144380400|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|1.3||||0.766|TWO_SIDED|95.0|-7.47|10.07|||ANCOVA|||The change in mean Motricity Index score was compared between treatment groups using ANCOVA. The model included treatment and centre as factors and baseline Motricity Index score as a covariate.||10.07|-7.47|0.766
72433690|NCT00711646|144380401|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|8.46||||0.349|TWO_SIDED|95.0|-6.74|23.66|||Fisher Exact|||The proportion of subjects who considered their condition 'Very Much Improved', 'Much Improved' or 'Minimally Improved' was compared between treatment groups using Fisher's Exact Test.||23.66|-6.74|0.349
72433691|NCT00711646|144380403|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|3.86||||0.054|TWO_SIDED|95.0|-0.06|7.78|||ANCOVA|||The change in mean Motricity Index score was compared between treatment groups using ANCOVA. The model included treatment and centre as factors and baseline Motricity Index score as a covariate.||7.78|-0.06|0.054
72433692|NCT01020838|144380469|SUPERIORITY_OR_OTHER||Sensitivity|0.774|||||TWO_SIDED|95.0|0.654|0.894|||||Point estimate of sensitivity was calculated by the method of Rao and Scott. Variance for sensitivity is based on subjects that contribute at least one brain region, which is amyloid positive according to the SoT|"For the primary analysis, point estimates together with normal-approximated, two sided 95% confidence intervals, were given for sensitivity in beta-amyloid detection based on the majority read.~The following hypothesis was formulated for sensitivity:~H0,sens: sensitivity ≤ 0.6 vs. H1, sens: sensitivity \> 0.6 H0,sens was to be rejected if the lower bound of the two-sided 95% CI is larger than 0.6"||0.894|0.654|
72433693|NCT01020838|144380469|SUPERIORITY_OR_OTHER||Specificity|0.942|||||TWO_SIDED|95.0|0.886|0.998|||||Point estimate of specificity was calculated using the method of Rao and Scott. Variance for specificity is based on subjects that contribute at least one brain region, which is amyloid negative according to the SoT|"For the primary analysis, point estimates together with normal-approximated, two sided 95% confidence intervals, were given for specificity in amyloid detection based on the majority read.~The following hypothesis was formulated for specificity:~H0,spec: specificity ≤ 0.8 vs. H1, spec: specificity \> 0.8 H0,spec was to be rejected if the lower bound of the two-sided 95% CI is larger than 0.8"||0.998|0.886|
72433694|NCT00930813|144380494|SUPERIORITY_OR_OTHER|||||||0.016|TWO_SIDED||||||t-test, 2 sided|||The study required 100 subjects to provide 80% power to detect a clinically meaningful difference in late lumen loss of 15% of reference vessel diameter between treatment groups on the basis of a 2-sample Student t test with 2-sided alpha 0.05.||||0.016
72433695|NCT00315120|144380505|SUPERIORITY_OR_OTHER||Response ratio|2.0||||0.007|TWO_SIDED|95.0|1.2|3.2|||Chi-squared|||||3.2|1.2|0.007
72433696|NCT00315120|144380510|SUPERIORITY_OR_OTHER||Response ratio|1.1||||0.72|TWO_SIDED|95.0|0.7|1.7|||Chi-squared|||||1.7|0.7|0.72
72433697|NCT02145182|144380540|SUPERIORITY||Odds Ratio (OR)|0.81||||0.3983|TWO_SIDED|95.0|0.49|1.33|||Regression, Logistic|Logistic regression results for the DGF composite, the effect of treatment adjusted for preservation type, donor type, and Irish score.|Calculated using the logistic regression model.|Analysis of DGF composite||1.33|0.49|0.3983
72618625|NCT01026038|144768106|SUPERIORITY_OR_OTHER||GMC ratio|1.06|||||TWO_SIDED|95.0|0.61|1.87||||||Serotype 3: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||1.87|0.61|
72433698|NCT00558363|144380561|SUPERIORITY_OR_OTHER||Relative Risk (Hazard Ratio)|0.34|||<|0.001|TWO_SIDED|95.0|0.23|0.5||Comparing 24-month survival curves (includes time to PSA doubling as well as time to censoring); stratified by site cluster and previous therapy|Log Rank||Relative risk of dutasteride compared to placebo, derived from Cox Proportional Hazard model stratified by site cluster and previous therapy|||0.50|0.23|<0.001
72433699|NCT00558363|144380571|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Comparing percentages of participants with PSA doubling: 57% versus 28%|Mantel-Haenszel Chi-Square|||||||<0.001
72433700|NCT00558363|144380572|SUPERIORITY_OR_OTHER||Relative Risk (Hazard Ratio)|0.25|||<|0.001||95.0|0.14|0.45||Comparing 12-month survival curves (includes time to PSA doubling as well as time to censoring); stratified by site cluster and previous therapy|Log Rank||Relative risk of dutasteride compared to placebo, derived from Cox proportional hazard model stratified by site cluster and previous therapy|||0.45|0.14|<0.001
72433701|NCT00558363|144380573|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Comparing percentages of participants with PSA doubling: 35% versus 10%|Mantel-Haenszel Chi-Square|||||||<0.001
72433702|NCT03102710|144380586|SUPERIORITY|Covariates included 1) age, 2) cream randomization, and 3) the difference in ERS for lidocaine before and after expectancy manipulation (which represented how well the expectancy was modulated) in Session 2.|Mean Difference (Final Values)|0.4||||0.03|TWO_SIDED|||||The threshold for significance was \<0.05.|ANCOVA||The mean difference between anodal vs. sham was 0.4, between cathodal vs. sham was 1.2, and between anodal vs. cathodal was -0.8.|To assess the modulation effects of tDCS on placebo, we first performed an analysis of covariance (ANCOVA) with placebo as the dependent variable and group (i.e., anodal, cathodal, and sham tDCS) as the fixed factor.||||0.03
72493949|NCT01562548|144516794|SUPERIORITY_OR_OTHER||Least Squares Means Difference|0.35||||0.52|TWO_SIDED|95.0|-0.72|1.42||P-value associated with t-test for difference of LS means|t-test, 2 sided||Least Square mean from Mixed Model including factors for treatment (as a fixed effect) and site (as a random effect). Difference was First named treatment - second named treatment|Null hypotheses was tested as: H01: There was no difference in the mean change from baseline of muscle spasm score between Guaifenesin 600mg and placebo. H02: There was no difference in the mean change from baseline of muscle spasm score between Guaifenesin 1200mg and placebo. H03: There was no difference in the mean change from baseline of muscle spasm score between Guaifenesin 1200mg and Guaifenesin 600mg.||1.42|-0.72|0.52
72433703|NCT03102710|144380586|SUPERIORITY|Covariates included 1) age, 2) cream randomization, and 3) the difference in ERS for capsaicin before and after expectancy manipulation (which represented how well the expectancy was modulated) in Session 2. In addition, we added the STAI state and trait anxiety scores as covariates when assessing the modulation effects of tDCS on the nocebo effect, as previous studies have suggested that anxiety level could affect nocebo hyperalgesia.|Mean Difference (Final Values)|1.3||||0.04|TWO_SIDED|||||The threshold for significance was \<0.05.|ANCOVA||The mean difference between anodal vs. sham was 1.4, between cathodal vs. sham was 1.0, and between anodal vs. cathodal was -0.3.|To assess the modulation effects of tDCS on nocebo, we first performed an analysis of covariance (ANCOVA) with nocebo as the dependent variable and group (i.e., anodal, cathodal, and sham tDCS) as the fixed factor.||||0.04
72433704|NCT00742274|144380602|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||||||<0.001
72433705|NCT01101165|144380603|NON_INFERIORITY_OR_EQUIVALENCE|A mixed-model analysis of variance was used to compare (test vs reference) and the 90% confidence intervals were estimated for the ratios (test/reference).|Geometric Test/Ref Ratio x 100|96.6|||||TWO_SIDED|90.0|92.8|100.56|||ANOVA||Bioequivalence is established when 90% Confidence Interval falls within 80%-125%.|||100.56|92.80|
72433706|NCT01101165|144380604|NON_INFERIORITY_OR_EQUIVALENCE|A mixed-model analysis of variance was used to compare (test vs reference) and the 90% confidence intervals were estimated for the ratios (test/reference)|Geometric Test/Ref Ratio x 100|94.8|||||TWO_SIDED|90.0|92.42|97.24|||ANOVA||Bioequivalence is established when 90% Confidence Interval falls within 80%-125%.|||97.24|92.42|
72433707|NCT01101165|144380605|NON_INFERIORITY_OR_EQUIVALENCE|A mixed-model analysis of variance was used to compare (test vs reference) and the 90% confidence intervals were estimated for the ratios (test/reference)|Geometric Test/Ref Ratio x 100|95.5|||||TWO_SIDED|90.0|92.93|98.18|||ANOVA||Bioequivalence is established when 90% Confidence Interval falls within 80%-125%.|||98.18|92.93|
72433708|NCT02219490|144380610|SUPERIORITY||||||<|0.001|||||||Log-rank test|||Comparisons between participants in studies M14-222 and M14-423 who achieved SVR12 and those who did not were performed using a log-rank test.||||<0.001
72433709|NCT02219490|144380610|SUPERIORITY||Cox Proportional Hazard Ratio|0.126|||<|0.001|TWO_SIDED|95.0|0.044|0.358|||Cox proportional hazards model||The estimated value represents the hazard ratio for developing the event in the group of participants in studies M14-222 and M14-423 who achieved SVR12 compared to the group of participants in studies M14-222 and M14-423 who didn't achieve SVR12.|A Cox proportional hazards (PH) model was constructed. The covariates for the model included baseline age, BMI, HCV genotype 1 subtype (1b, non-1b), IL28B genotype (CC, non-CC), prior treatment history (naive, experienced), baseline HCV RNA levels, baseline fibrosis stage (F0-1, F2, F3, F4), baseline albumin, baseline creatinine clearance, baseline platelet count, history of diabetes (yes, no), APRI, race (white, other), and alcohol use status (current, former, non-drinker).||0.358|0.044|<0.001
72556533|NCT00506831|144644277|SUPERIORITY_OR_OTHER|||||||0.005||95.0|||||t-test, 2 sided|||Null hypothesis is that the mRSS is not significantly different at month 6 compared with baseline. Paired t-test was used to compare the mean mRSS at month 6 compared with baseline.||||0.005
72433710|NCT02219490|144380611|SUPERIORITY||||||<|0.001|||||||Log-rank test|||Comparisons between participants in studies M14-222 and M14-423 who achieved SVR12 and those who did not were performed using a log-rank test.||||<0.001
72433711|NCT02219490|144380611|SUPERIORITY||Cox Proportional Hazard Ratio|0.031||||0.007|TWO_SIDED|95.0|0.003|0.38|||Cox proportional hazards model||The estimated value represents the hazard ratio for developing the event in the group of participants in studies M14-222 and M14-423 who achieved SVR12 compared to the group of participants in studies M14-222 and M14-423 who didn't achieve SVR12.|A Cox proportional hazards (PH) model was constructed. The covariates for the model included baseline age, BMI, HCV genotype 1 subtype (1b, non-1b), IL28B genotype (CC, non-CC), prior treatment history (naive, experienced), baseline HCV RNA levels, baseline fibrosis stage (F0-1, F2, F3, F4), baseline albumin, baseline creatinine clearance, baseline platelet count, history of diabetes (yes, no), APRI, race (white, other), and alcohol use status (current, former, non-drinker).||0.380|0.003|0.007
72433712|NCT02219490|144380612|SUPERIORITY||||||<|0.001|||||||Log-rank test|||Comparisons between participants in studies M14-222 and M14-423 who achieved SVR12 and those who did not were performed using a log-rank test.||||<0.001
72433713|NCT02219490|144380612|SUPERIORITY||Cox Proportional Hazard Ratio|0.038|||<|0.001|TWO_SIDED|95.0|0.009|0.156|||Cox proportional hazards model||The estimated value represents the hazard ratio for developing the event in the group of participants in studies M14-222 and M14-423 who achieved SVR12 compared to the group of participants in studies M14-222 and M14-423 who didn't achieve SVR12.|A Cox proportional hazards (PH) model was constructed. The covariates for the model included baseline age, BMI, HCV genotype 1 subtype (1b, non-1b), IL28B genotype (CC, non-CC), prior treatment history (naive, experienced), baseline HCV RNA levels, baseline fibrosis stage (F0-1, F2, F3, F4), baseline albumin, baseline creatinine clearance, baseline platelet count, history of diabetes (yes, no), APRI, race (white, other), and alcohol use status (current, former, non-drinker).||0.156|0.009|<0.001
72433714|NCT02219490|144380613|SUPERIORITY|||||||0.86|||||||Log-rank test|||Comparisons between participants in studies M14-222 and M14-423 who achieved SVR12 and those who did not were performed using a log-rank test.||||0.860
72433715|NCT02219490|144380613|SUPERIORITY|||||||0.997||||||The Hazard Ratio for experiencing the event in the group of participants in studies M14-222 and M14-423 who achieved SVR12 compared to those who did not achieve SVR12 is infinite and the CI is not bounded due to zero events in one of the groups.|Cox proportional hazards model|||A Cox proportional hazards (PH) model was constructed. The covariates for the model included baseline age, BMI, HCV genotype 1 subtype (1b, non-1b), IL28B genotype (CC, non-CC), prior treatment history (naive, experienced), baseline HCV RNA levels, baseline fibrosis stage (F0-1, F2, F3, F4), baseline albumin, baseline creatinine clearance, baseline platelet count, history of diabetes (yes, no), APRI, race (white, other), and alcohol use status (current, former, non-drinker).||||0.997
72556534|NCT02488239|144644297|OTHER||||||<|0.001|||||||exact binomial rate|||||||<0.001
72556535|NCT02488239|144644298|OTHER||||||<|0.001|||||||t-test, 1 sided|||||||<0.001
72556536|NCT02336074|144644323|SUPERIORITY|||||||0.26||||||Treatment arms were compared in terms of absolute total HIV DNA levels (on a log10-scale) at post-randomization weeks 16 and 18 adjusted for the baseline (i.e. randomization) level and by stratum.|Regression, Linear|||||||0.26
72433716|NCT02219490|144380614|SUPERIORITY|||||||0.608|||||||Log-rank test|||Comparisons between participants in studies M14-222 and M14-423 who achieved SVR12 and those who did not were performed using a log-rank test.||||0.608
72433717|NCT02219490|144380614|SUPERIORITY|||||||0.992||||||The Hazard Ratio for experiencing the event in the group of participants in studies M14-222 and M14-423 who achieved SVR12 compared to those who did not achieve SVR12 is infinite and the CI is not bounded due to zero events in one of the groups.|Cox proportional hazards model|||A Cox proportional hazards (PH) model was constructed. The covariates for the model included baseline age, BMI, HCV genotype 1 subtype (1b, non-1b), IL28B genotype (CC, non-CC), prior treatment history (naive, experienced), baseline HCV RNA levels, baseline fibrosis stage (F0-1, F2, F3, F4), baseline albumin, baseline creatinine clearance, baseline platelet count, history of diabetes (yes, no), APRI, race (white, other), and alcohol use status (current, former, non-drinker).||||0.992
72433718|NCT02219490|144380615|SUPERIORITY||||||<|0.001|||||||Log-rank test|||Comparisons between participants in studies M14-222 and M14-423 who achieved SVR12 and those who did not were performed using a log-rank test.||||<0.001
72433719|NCT02219490|144380615|SUPERIORITY||Cox Proportional Hazard Ratio|0.133|||<|0.001|TWO_SIDED|95.0|0.057|0.313|||Cox proportional hazards model||The estimated value represents the hazard ratio for developing the event in the group of participants in studies M14-222 and M14-423 who achieved SVR12 compared to the group of participants in studies M14-222 and M14-423 who didn't achieve SVR12.|A Cox proportional hazards (PH) model was constructed. The covariates for the model included baseline age, BMI, HCV genotype 1 subtype (1b, non-1b), IL28B genotype (CC, non-CC), prior treatment history (naive, experienced), baseline HCV RNA levels, baseline fibrosis stage (F0-1, F2, F3, F4), baseline albumin, baseline creatinine clearance, baseline platelet count, history of diabetes (yes, no), APRI, race (white, other), and alcohol use status (current, former, non-drinker).||0.313|0.057|<0.001
72433720|NCT02219490|144380616|SUPERIORITY||LS Mean Difference|1.0|STANDARD_ERROR_OF_MEAN|0.7||0.151|TWO_SIDED|95.0|-0.37|2.37|||ANCOVA||Difference = with SVR12 minus without SVR12|"Final Treatment Visit~The effect of sustained virologic response on change from baseline in FibroScan score was evaluated by comparing mean change from baseline between subjects who achieved SVR12 and those who did not using ANCOVA analyses. SVR12 status was included as a factor and baseline FibroScan score was included as a covariate in the ANCOVA model."||2.37|-0.37|0.151
72433721|NCT02219490|144380616|SUPERIORITY||LS Mean Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.78||0.878|TWO_SIDED|95.0|-1.64|1.4|||ANCOVA||Difference = with SVR12 minus without SVR12|"Post-Treatment Week 12~The effect of sustained virologic response on change from baseline in FibroScan score was evaluated by comparing mean change from baseline between subjects who achieved SVR12 and those who did not using ANCOVA analyses. SVR12 status was included as a factor and baseline FibroScan score was included as a covariate in the ANCOVA model."||1.4|-1.64|0.878
72433722|NCT02219490|144380616|SUPERIORITY||LS Mean Difference|-0.92|STANDARD_ERROR_OF_MEAN|0.72|=|0.199|TWO_SIDED|95.0|-2.33|0.48|||ANCOVA||Difference = with SVR12 minus without SVR12|"Post-Treatment Week 24~The effect of sustained virologic response on change from baseline in FibroScan score was evaluated by comparing mean change from baseline between subjects who achieved SVR12 and those who did not using ANCOVA analyses. SVR12 status was included as a factor and baseline FibroScan score was included as a covariate in the ANCOVA model."||0.48|-2.33|=0.199
72433723|NCT02219490|144380616|SUPERIORITY||LS Mean Difference|-2.16|STANDARD_ERROR_OF_MEAN|0.93||0.021|TWO_SIDED|95.0|-4.0|-0.33|||ANCOVA||Difference = with SVR12 minus without SVR12|"Post-Treatment Week 52~The effect of sustained virologic response on change from baseline in FibroScan score was evaluated by comparing mean change from baseline between subjects who achieved SVR12 and those who did not using ANCOVA analyses. SVR12 status was included as a factor and baseline FibroScan score was included as a covariate in the ANCOVA model."||-0.33|-4|0.021
72433724|NCT02219490|144380616|SUPERIORITY||LS Mean Difference|-2.47|STANDARD_ERROR_OF_MEAN|0.89||0.006|TWO_SIDED|95.0|-4.22|-0.71|||ANCOVA||Difference = with SVR12 minus without SVR12|"Post-Treatment Week 104~The effect of sustained virologic response on change from baseline in FibroScan score was evaluated by comparing mean change from baseline between subjects who achieved SVR12 and those who did not using ANCOVA analyses. SVR12 status was included as a factor and baseline FibroScan score was included as a covariate in the ANCOVA model."||-0.71|-4.22|0.006
72433725|NCT02219490|144380616|SUPERIORITY||LS Mean Difference|-2.58|STANDARD_ERROR_OF_MEAN|0.92||0.005|TWO_SIDED|95.0|-4.38|-0.79|||ANCOVA||Difference = with SVR12 minus without SVR12|"Post-Treatment Week 156~The effect of sustained virologic response on change from baseline in FibroScan score was evaluated by comparing mean change from baseline between subjects who achieved SVR12 and those who did not using ANCOVA analyses. SVR12 status was included as a factor and baseline FibroScan score was included as a covariate in the ANCOVA model."||-0.79|-4.38|0.005
72433726|NCT02219490|144380616|SUPERIORITY||LS Mean Difference|-1.36|STANDARD_ERROR_OF_MEAN|1.0||0.172|TWO_SIDED|95.0|-3.32|0.59|||ANCOVA||Difference = with SVR12 minus without SVR12|"Post-Treatment Week 208~The effect of sustained virologic response on change from baseline in FibroScan score was evaluated by comparing mean change from baseline between subjects who achieved SVR12 and those who did not using ANCOVA analyses. SVR12 status was included as a factor and baseline FibroScan score was included as a covariate in the ANCOVA model."||0.59|-3.32|0.172
72433727|NCT02219490|144380616|SUPERIORITY||LS Mean Difference|-1.13|STANDARD_ERROR_OF_MEAN|1.14||0.322|TWO_SIDED|95.0|-3.35|1.1|||ANCOVA||Difference = with SVR12 minus without SVR12|"Post-Treatment Week 260~The effect of sustained virologic response on change from baseline in FibroScan score was evaluated by comparing mean change from baseline between subjects who achieved SVR12 and those who did not using ANCOVA analyses. SVR12 status was included as a factor and baseline FibroScan score was included as a covariate in the ANCOVA model."||1.1|-3.35|0.322
72556537|NCT02336074|144644325|SUPERIORITY||Odds Ratio (OR)|0.41||||0.145|TWO_SIDED||||||Regression, Logistic|||"Comparison of the proportion of patients with undetectable viral outgrowth using logistic regression.~The analysis was adjusted for stratum and baseline viral outgrowth. Missing baseline values were imputed."||||0.145
72433728|NCT03879642|144380636|SUPERIORITY||partial eta squared|0.117|||||TWO_SIDED||||||ANOVA|||||||
72433729|NCT03879642|144380637|SUPERIORITY||partial eta squared|0.005|||||TWO_SIDED||||||repeated measures ANOVA|||||||
72433730|NCT03404843|144380656|OTHER|||||||0.97|||||||ANOVA|||Within group comparison of treatment||||0.97
72433731|NCT03404843|144380656|OTHER||||||<|0.05|||||||ANOVA|||Within group comparison of treatment||||<0.05
72433732|NCT03404843|144380657|OTHER||||||<|0.05|||||||ANOVA|||Within group comparison of treatment||||<0.05
72433733|NCT03404843|144380657|OTHER||||||<|0.05|||||||ANOVA|||Within group comparison of treatment||||<0.05
72433734|NCT03404843|144380658|OTHER|||||||0.28|||||||ANOVA|||Within group comparison of treatment||||0.28
72433735|NCT03404843|144380658|OTHER|||||||0.37|||||||ANOVA|||Within group comparison of treatment||||0.37
72433736|NCT03404843|144380659|OTHER|||||||0.89|||||||ANOVA|||Within group comparison of treatment||||0.89
72433737|NCT03404843|144380659|OTHER|||||||0.3|||||||ANOVA|||Within group comparison of treatment||||0.30
72381411|NCT00395538|144271231|OTHER|A contrast statement within the mixed models analysis tested for differences in the Cn.O.Th between the baseline and the year 1 biopsy.||||||0.003||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Cn.O.Th at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.003
72381412|NCT00395538|144271231|OTHER|A contrast statement within the mixed models analysis tested for differences in the Cn.O.Th between the baseline and the years 2 and 4 (combined) biopsy.|||||<|0.001||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Cn.O.Th at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||<0.001
72381413|NCT00395538|144271231|OTHER|A contrast statement within the mixed models analysis tested for differences in the Cn.O.Th between the year 1 biopsy and the years 2 and 4 (combined) biopsy.||||||0.68||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Cn.O.Th at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.680
72381414|NCT00395538|144271232|OTHER|A contrast statement within the mixed models analysis tested for differences in the Cn.MAR between the baseline and the year 1 biopsy.||||||0.006||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Cn.MAR at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.006
72433738|NCT03404843|144380660|OTHER|||||||0.08|||||||ANOVA|||Within group comparison of treatment||||0.08
72433739|NCT03404843|144380660|OTHER|||||||0.05|||||||ANOVA|||Within group comparison of treatment||||0.05
72433740|NCT00567164|144380662|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.85|STANDARD_DEVIATION|30.356||0.0001||95.0|-16.3|-7.394|||t-test, 2 sided|||||-7.394|-16.3|0.0001
72433741|NCT03441984|144380685|OTHER||Ratio of geometric LS means|1.6946|||||TWO_SIDED|90.0|1.569|1.8373|||||Treatment comparison of pediatric TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg dispersible tablets) and adult TRIUMEQ (DTG 50 mg/ABC 600 mg/3TC 300 mg tablet) is presented|||1.8373|1.5690|
72433742|NCT03441984|144380685|OTHER||Ratio of geometric LS means|1.3512|||||TWO_SIDED|90.0|1.2465|1.4647|||||Treatment comparison of pediatric TRUMEQ (DTG 5 mg/ABC 60 mg/3TC 30mg dispersible tablet direct to mouth) and adult TRIUMEQ (DTG 50 mg/ABC 600 mg/3TC 300 mg tablet) is presented.|||1.4647|1.2465|
72433743|NCT03441984|144380685|OTHER||Ratio of geometric LS means|1.2541|||||TWO_SIDED|90.0|1.1569|1.3595|||||Treatment comparison of pediatric TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg dispersible tablets) and pediatric TRUMEQ (DTG 5 mg/ABC 60 mg/3TC 30mg dispersible tablet direct to mouth) is presented|||1.3595|1.1569|
72433744|NCT03441984|144380686|OTHER||Ratio of geometric LS means|1.7001|||||TWO_SIDED|90.0|1.5685|1.8428|||||Treatment comparison of pediatric TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg dispersible tablets) and adult TRIUMEQ (DTG 50 mg/ABC 600 mg/3TC 300 mg tablet) is presented.|||1.8428|1.5685|
72433745|NCT03441984|144380686|OTHER||Ratio of geometric LS means|1.3519|||||TWO_SIDED|90.0|1.2475|1.465|||||Treatment comparison of pediatric TRUMEQ (DTG 5 mg/ABC 60 mg/3TC 30mg dispersible tablet direct to mouth) and adult TRIUMEQ (DTG 50 mg/ABC 600 mg/3TC 300 mg tablet) is presented.|||1.4650|1.2475|
72433746|NCT03441984|144380686|OTHER||Ratio of geometric LS means|1.2576|||||TWO_SIDED|90.0|1.1605|1.3629|||||Treatment comparison of pediatric TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg dispersible tablets) and pediatric TRUMEQ (DTG 5 mg/ABC 60 mg/3TC 30mg dispersible tablet direct to mouth) is presented.|||1.3629|1.1605|
72433747|NCT03441984|144380687|OTHER||Ratio of geometric LS means|1.7382|||||TWO_SIDED|90.0|1.5983|1.8904|||||Treatment comparison of pediatric TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg dispersible tablets) and adult TRIUMEQ (DTG 50 mg/ABC 600 mg/3TC 300 mg tablet) is presented.|||1.8904|1.5983|
72433748|NCT03441984|144380687|OTHER||Ratio of geometric LS means|1.3614|||||TWO_SIDED|90.0|1.2525|1.4798|||||Treatment comparison of pediatric TRUMEQ (DTG 5 mg/ABC 60 mg/3TC 30mg dispersible tablet direct to mouth) and adult TRIUMEQ (DTG 50 mg/ABC 600 mg/3TC 300 mg tablet) is presented.|||1.4798|1.2525|
72433749|NCT03441984|144380687|OTHER||Ratio of geometric LS means|1.2768|||||TWO_SIDED|90.0|1.1746|1.3878|||||Treatment comparison of pediatric TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg dispersible tablets) and pediatric TRUMEQ (DTG 5 mg/ABC 60 mg/3TC 30mg dispersible tablet direct to mouth) is presented.|||1.3878|1.1746|
72433750|NCT03441984|144380688|OTHER||Ratio of geometric LS means|1.0407|||||TWO_SIDED|90.0|1.0118|1.0704|||||Treatment comparison of pediatric TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg dispersible tablets) and adult TRIUMEQ (DTG 50 mg/ABC 600 mg/3TC 300 mg tablet) is presented.|||1.0704|1.0118|
72433751|NCT03441984|144380688|OTHER||Ratio of geometric LS means|1.0228|||||TWO_SIDED|90.0|0.9944|1.052|||||Treatment comparison of pediatric TRUMEQ (DTG 5 mg/ABC 60 mg/3TC 30mg dispersible tablet direct to mouth) and adult TRIUMEQ (DTG 50 mg/ABC 600 mg/3TC 300 mg tablet) is presented.|||1.0520|0.9944|
72433752|NCT03441984|144380688|OTHER||Ratio of geometric LS means|1.0175|||||TWO_SIDED|90.0|0.9893|1.0465|||||Treatment comparison of pediatric TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg dispersible tablets) and pediatric TRUMEQ (DTG 5 mg/ABC 60 mg/3TC 30mg dispersible tablet direct to mouth) is presented.|||1.0465|0.9893|
72433753|NCT03441984|144380689|OTHER||Ratio of geometric LS means|1.041|||||TWO_SIDED|90.0|1.0121|1.0708|||||Treatment comparison of pediatric TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg dispersible tablets) and adult TRIUMEQ (DTG 50 mg/ABC 600 mg/3TC 300 mg tablet) is presented.|||1.0708|1.0121|
72433754|NCT03441984|144380689|OTHER||Ratio of geometric LS means|1.0232|||||TWO_SIDED|90.0|0.9948|1.0524|||||Treatment comparison of pediatric TRUMEQ (DTG 5 mg/ABC 60 mg/3TC 30mg dispersible tablet direct to mouth) and adult TRIUMEQ (DTG 50 mg/ABC 600 mg/3TC 300 mg tablet) is presented.|||1.0524|0.9948|
72433755|NCT03441984|144380689|OTHER||Ratio of geometric LS means|1.0174|||||TWO_SIDED|90.0|0.9892|1.0465|||||Treatment comparison of pediatric TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg dispersible tablets) and pediatric TRUMEQ (DTG 5 mg/ABC 60 mg/3TC 30mg dispersible tablet direct to mouth) is presented.|||1.0465|0.9892|
72433756|NCT03441984|144380690|OTHER||Ratio of geometric LS means|1.0533|||||TWO_SIDED|90.0|0.9885|1.1223|||||Treatment comparison of pediatric TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg dispersible tablets) and adult TRIUMEQ (DTG 50 mg/ABC 600 mg/3TC 300 mg tablet) is presented.|||1.1223|0.9885|
72433757|NCT03441984|144380690|OTHER||Ratio of geometric LS means|0.9766|||||TWO_SIDED|90.0|0.9167|1.0405|||||Treatment comparison of pediatric TRUMEQ (DTG 5 mg/ABC 60 mg/3TC 30mg dispersible tablet direct to mouth) and adult TRIUMEQ (DTG 50 mg/ABC 600 mg/3TC 300 mg tablet) is presented.|||1.0405|0.9167|
72433758|NCT03441984|144380690|OTHER||Ratio of geometric LS means|1.0785|||||TWO_SIDED|90.0|1.0123|1.149|||||Treatment comparison of pediatric TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg dispersible tablets) and pediatric TRUMEQ (DTG 5 mg/ABC 60 mg/3TC 30mg dispersible tablet direct to mouth) is presented.|||1.1490|1.0123|
72433759|NCT03441984|144380691|OTHER||Ratio of geometric LS means|1.0|||||TWO_SIDED|90.0|0.9536|1.0486|||||Treatment comparison of pediatric TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg dispersible tablets) and adult TRIUMEQ (DTG 50 mg/ABC 600 mg/3TC 300 mg tablet) is presented.|||1.0486|0.9536|
72433760|NCT03441984|144380691|OTHER||Ratio of geometric LS means|0.9478|||||TWO_SIDED|90.0|0.9039|0.9939|||||Treatment comparison of pediatric TRUMEQ (DTG 5 mg/ABC 60 mg/3TC 30mg dispersible tablet direct to mouth) and adult TRIUMEQ (DTG 50 mg/ABC 600 mg/3TC 300 mg tablet) is presented.|||0.9939|0.9039|
72618626|NCT01026038|144768106|SUPERIORITY_OR_OTHER||GMC ratio|1.19|||||TWO_SIDED|95.0|0.68|2.09||||||Serotype 3: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||2.09|0.68|
72618627|NCT01026038|144768106|SUPERIORITY_OR_OTHER||GMC ratio|1.12|||||TWO_SIDED|95.0|0.59|2.15||||||Serotype 3: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||2.15|0.59|
72433761|NCT03441984|144380691|OTHER||Ratio of geometric LS means|1.055|||||TWO_SIDED|90.0|1.0061|1.1063|||||Treatment comparison of pediatric TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg dispersible tablets) and pediatric TRUMEQ (DTG 5 mg/ABC 60 mg/3TC 30mg dispersible tablet direct to mouth) is presented.|||1.1063|1.0061|
72433762|NCT03441984|144380692|OTHER||Ratio of geometric LS means|0.9994|||||TWO_SIDED|90.0|0.9525|1.0486|||||Treatment comparison of pediatric TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg dispersible tablets) and adult TRIUMEQ (DTG 50 mg/ABC 600 mg/3TC 300 mg tablet) is presented.|||1.0486|0.9525|
72433763|NCT03441984|144380692|OTHER||Ratio of geometric LS means|0.9432|||||TWO_SIDED|90.0|0.899|0.9896|||||Treatment comparison of pediatric TRUMEQ (DTG 5 mg/ABC 60 mg/3TC 30mg dispersible tablet direct to mouth) and adult TRIUMEQ (DTG 50 mg/ABC 600 mg/3TC 300 mg tablet) is presented.|||0.9896|0.8990|
72433764|NCT03441984|144380692|OTHER||Ratio of geometric LS means|1.0596|||||TWO_SIDED|90.0|1.0099|1.1117|||||Treatment comparison of pediatric TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg dispersible tablets) and pediatric TRUMEQ (DTG 5 mg/ABC 60 mg/3TC 30mg dispersible tablet direct to mouth) is presented.|||1.1117|1.0099|
72433765|NCT03441984|144380693|OTHER||Ratio of geometric LS means|0.9362|||||TWO_SIDED|90.0|0.8677|1.0101|||||Treatment comparison of pediatric TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg dispersible tablets) and adult TRIUMEQ (DTG 50 mg/ABC 600 mg/3TC 300 mg tablet) is presented.|||1.0101|0.8677|
72433766|NCT03441984|144380693|OTHER||Ratio of geometric LS means|0.9079|||||TWO_SIDED|90.0|0.8416|0.9795|||||Treatment comparison of pediatric TRUMEQ (DTG 5 mg/ABC 60 mg/3TC 30mg dispersible tablet direct to mouth) and adult TRIUMEQ (DTG 50 mg/ABC 600 mg/3TC 300 mg tablet) is presented.|||0.9795|0.8416|
72433767|NCT03441984|144380693|OTHER||Ratio of geometric LS means|1.0312|||||TWO_SIDED|90.0|0.9558|1.1124|||||Treatment comparison of pediatric TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg dispersible tablets) and pediatric TRUMEQ (DTG 5 mg/ABC 60 mg/3TC 30mg dispersible tablet direct to mouth) is presented.|||1.1124|0.9558|
72433768|NCT03441984|144380694|OTHER||Ratio of geometric LS means|1.6439|||||TWO_SIDED|90.0|1.4649|1.8449|||||Treatment comparison of pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet) and adult DTG/3TC (DTG 50 mg/3TC 300 mg tablet) is presented.|||1.8449|1.4649|
72433769|NCT03441984|144380694|OTHER||Ratio of geometric LS means|1.2698|||||TWO_SIDED|90.0|1.1315|1.425|||||Treatment comparison of pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet direct to mouth) and pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet) is presented.|||1.4250|1.1315|
72433770|NCT03441984|144380694|OTHER||Ratio of geometric LS means|1.2946|||||TWO_SIDED|90.0|1.1536|1.4529|||||Treatment comparison of pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet direct to mouth) and pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet direct to mouth) is presented.|||1.4529|1.1536|
72433771|NCT03441984|144380695|OTHER||Ratio of geometric LS means|1.6578|||||TWO_SIDED|90.0|1.4709|1.8685|||||Treatment comparison of pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet) and adult DTG/3TC (DTG 50 mg/3TC 300 mg tablet) is presented.|||1.8685|1.4709|
72556538|NCT02679729|144644331|SUPERIORITY_OR_OTHER||Slope|0.625|||||TWO_SIDED|95.0|0.396|0.853||||||Statistical Analysis for Part A||0.853|0.396|
72556539|NCT02679729|144644332|SUPERIORITY_OR_OTHER||Slope|1.2|||||TWO_SIDED|95.0|0.905|1.49||||||Statistical Analysis for Part A||1.49|0.905|
72433772|NCT03441984|144380695|OTHER||Ratio of geometric LS means|1.2755|||||TWO_SIDED|90.0|1.1317|1.4375|||||Treatment comparison of pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet direct to mouth) and pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet) is presented.|||1.4375|1.1317|
72433773|NCT03441984|144380695|OTHER||Ratio of geometric LS means|1.2998|||||TWO_SIDED|90.0|1.1533|1.465|||||Treatment comparison of pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet direct to mouth) and pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet direct to mouth) is presented.|||1.4650|1.1533|
72433774|NCT03441984|144380696|OTHER||Ratio of geometric LS means|1.9758|||||TWO_SIDED|90.0|1.7585|2.2201|||||Treatment comparison of pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet) and adult DTG/3TC (DTG 50 mg/3TC 300 mg tablet) is presented.|||2.2201|1.7585|
72433775|NCT03441984|144380696|OTHER||Ratio of geometric LS means|1.2873|||||TWO_SIDED|90.0|1.1457|1.4465|||||Treatment comparison of pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet direct to mouth) and pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet) is presented.|||1.4465|1.1457|
72433776|NCT03441984|144380696|OTHER||Ratio of geometric LS means|1.5348|||||TWO_SIDED|90.0|1.366|1.7245|||||Treatment comparison of pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet direct to mouth) and pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet direct to mouth) is presented.|||1.7245|1.3660|
72433777|NCT03441984|144380697|OTHER||Ratio of geometric LS means|0.9798|||||TWO_SIDED|90.0|0.9241|1.0389|||||Treatment comparison of pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet) and adult DTG/3TC (DTG 50 mg/3TC 300 mg tablet) is presented.|||1.0389|0.9241|
72433778|NCT03441984|144380697|OTHER||Ratio of geometric LS means|0.9605|||||TWO_SIDED|90.0|0.9059|1.0185|||||Treatment comparison of pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet direct to mouth) and pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet) is presented.|||1.0185|0.9059|
72433779|NCT03441984|144380697|OTHER||Ratio of geometric LS means|1.0201|||||TWO_SIDED|90.0|0.9633|1.0802|||||Treatment comparison of pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet direct to mouth) and pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet direct to mouth) is presented.|||1.0802|0.9633|
72433780|NCT03441984|144380698|OTHER||Ratio of geometric LS means|0.9831|||||TWO_SIDED|90.0|0.9243|1.0457|||||Treatment comparison of pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet) and adult DTG/3TC (DTG 50 mg/3TC 300 mg tablet) is presented.|||1.0457|0.9243|
72433781|NCT03441984|144380698|OTHER||Ratio of geometric LS means|0.9702|||||TWO_SIDED|90.0|0.9121|1.032|||||Treatment comparison of pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet direct to mouth) and pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet) is presented.|||1.0320|0.9121|
72433782|NCT03441984|144380698|OTHER||Ratio of geometric LS means|1.0134|||||TWO_SIDED|90.0|0.9527|1.0779|||||Treatment comparison of pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet direct to mouth) and pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet direct to mouth) is presented.|||1.0779|0.9527|
72556540|NCT02679729|144644333|SUPERIORITY_OR_OTHER||Slope|1.55|||||TWO_SIDED|95.0|1.34|1.76||||||Statistical Analysis for Part A||1.76|1.34|
72433783|NCT03441984|144380699|OTHER||Ratio of geometric LS means|0.91|||||TWO_SIDED|90.0|0.8196|1.0102|||||Treatment comparison of pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet) and adult DTG/3TC (DTG 50 mg/3TC 300 mg tablet) is presented.|||1.0102|0.8196|
72433784|NCT03441984|144380699|OTHER||Ratio of geometric LS means|0.9198|||||TWO_SIDED|90.0|0.8285|1.0212|||||Treatment comparison of pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet direct to mouth) and pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet) is presented.|||1.0212|0.8285|
72433785|NCT03441984|144380699|OTHER||Ratio of geometric LS means|0.9893|||||TWO_SIDED|90.0|0.8911|1.0983|||||Treatment comparison of pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet direct to mouth) and pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet direct to mouth) is presented.|||1.0983|0.8911|
72433786|NCT03441984|144380705|OTHER||Ratio of geometric LS means|1.6503|||||TWO_SIDED|90.0|1.5131|1.8|||||Treatment comparison of pediatric TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg dispersible tablets) and adult TRIUMEQ (DTG 50 mg/ABC 600 mg/3TC 300 mg tablet) is presented.|||1.8000|1.5131|
72433787|NCT03441984|144380705|OTHER||Ratio of geometric LS means|1.3501|||||TWO_SIDED|90.0|1.2381|1.4722|||||Treatment comparison of pediatric TRUMEQ (DTG 5 mg/ABC 60 mg/3TC 30mg dispersible tablet direct to mouth) and adult TRIUMEQ (DTG 50 mg/ABC 600 mg/3TC 300 mg tablet) is presented.|||1.4722|1.2381|
72433788|NCT03441984|144380705|OTHER||Ratio of geometric LS means|1.2224|||||TWO_SIDED|90.0|1.121|1.333|||||Treatment comparison of pediatric TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg dispersible tablets) and pediatric TRUMEQ (DTG 5 mg/ABC 60 mg/3TC 30mg dispersible tablet direct to mouth) is presented.|||1.3330|1.1210|
72433789|NCT03441984|144380714|OTHER||Ratio of geometric LS means|1.0251|||||TWO_SIDED|90.0|0.848|1.2392|||||Treatment comparison between Pediatric TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg, 10 dispersible tablets) and Adult TRIUMEQ (DTG 50 mg/ABC 600 mg/3TC 300 mg, 1 conventional tablet) is presented|||1.2392|0.8480|
72433790|NCT03441984|144380714|OTHER||Ratio of geometric LS means|0.9181|||||TWO_SIDED|90.0|0.7592|1.1103|||||Treatment comparison between Pediatric TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg, 10 dispersible tablets) and Adult TRIUMEQ (DTG 50 mg/ABC 600 mg/3TC 300 mg, 1 conventional tablet) is presented|||1.1103|0.7592|
72433791|NCT03441984|144380714|OTHER||Ratio of geometric LS means|1.1165|||||TWO_SIDED|90.0|0.9376|1.3295|||||Treatment comparison between Pediatric TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg, 10 dispersible tablets) and Pediatric TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg, 10 dispersible tablets) is presented|||1.3295|0.9376|
72433792|NCT03441984|144380722|OTHER||Ratio of geometric LS means|1.0844|||||TWO_SIDED|90.0|0.9904|1.1873|||||Treatment comparison between Pediatric TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg, 10 dispersible tablets) and Adult TRIUMEQ (DTG 50 mg/ABC 600 mg/3TC 300 mg, 1 conventional tablet) is presented|||1.1873|0.9904|
72433793|NCT03441984|144380722|OTHER||Ratio of geometric LS means|1.1311|||||TWO_SIDED|90.0|1.0334|1.2379|||||Treatment comparison between Pediatric TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg, 10 dispersible tablets) and Adult TRIUMEQ (DTG 50 mg/ABC 600 mg/3TC 300 mg, 1 conventional tablet) is presented|||1.2379|1.0334|
72556541|NCT04667338|144644347|SUPERIORITY||||||=|0.5061|||||||Chi-squared|||Pharmacological||||=0.5061
72556542|NCT04667338|144644347|SUPERIORITY||||||=|0.2053|||||||Chi-squared|||Non-pharmacological||||=0.2053
72556543|NCT04667338|144644348|SUPERIORITY||||||=|0.4016|||||||Chi-squared|||||||=0.4016
72556544|NCT04667338|144644351|SUPERIORITY||||||=|0.5274|||||||Chi-squared|||Educational level ongoing or completed level of education||||=0.5274
72556545|NCT04667338|144644351|SUPERIORITY||||||=|0.7051|||||||Chi-squared|||Occupational status and occupation||||=0.7051
72433794|NCT03441984|144380722|OTHER||Ratio of geometric LS means|0.9587|||||TWO_SIDED|90.0|0.876|1.0493|||||Treatment comparison of pediatric TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg dispersible tablets) and pediatric TRUMEQ (DTG 5 mg/ABC 60 mg/3TC 30mg dispersible tablet direct to mouth) is presented.|||1.0493|0.8760|
72433795|NCT03441984|144380730|OTHER||Ratio of geometric LS means|1.5619|||||TWO_SIDED|90.0|1.3678|1.7835|||||Treatment comparison between Pediatric DTG/3TC (DTG 5 mg/3TC 30 mg, 10 dispersible tablets) and Adult DTG (50 mg, 1 conventional tablet) and adult 3TC (300 mg, 1 conventional tablet) is presented|||1.7835|1.3678|
72433796|NCT03441984|144380730|OTHER||Ratio of geometric LS means|1.253|||||TWO_SIDED|90.0|1.0973|1.4307|||||Treatment comparison of pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet direct to mouth) and pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet) is presented.|||1.4307|1.0973|
72433797|NCT03441984|144380730|OTHER||Ratio of geometric LS means|1.2466|||||TWO_SIDED|90.0|1.0917|1.4234|||||Treatment comparison of pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet direct to mouth) and pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet direct to mouth) is presented.|||1.4234|1.0917|
72433798|NCT03441984|144380739|OTHER||Ratio of geometric LS means|1.0745|||||TWO_SIDED|90.0|0.9997|1.1549|||||Treatment comparison between Pediatric DTG/3TC (DTG 5 mg/3TC 30 mg, 10 dispersible tablets) and Adult DTG (50 mg, 1 conventional tablet) and adult 3TC (300 mg, 1 conventional tablet) is presented|||1.1549|0.9997|
72433799|NCT03441984|144380739|OTHER||Ratio of geometric LS means|1.0706|||||TWO_SIDED|90.0|0.9961|1.1507|||||Treatment comparison of pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet direct to mouth) and pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet) is presented.|||1.1507|0.9961|
72433800|NCT03441984|144380739|OTHER||Ratio of geometric LS means|1.0036|||||TWO_SIDED|90.0|0.9338|1.0787|||||Treatment comparison of pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet direct to mouth) and pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet direct to mouth) is presented.|||1.0787|0.9338|
72433801|NCT01879371|144380827|SUPERIORITY_OR_OTHER||Geometric mean ratio (net)|107.85|||||TWO_SIDED|90.0|105.334|110.431|||||The geometric mean ratio is calculated as the geometric mean of 'Ibuprofen + Caffeine (FDC) tablet ' divided by the geometric mean of ' Ibuprofen acid film-coated tablet '.|"The ANOVA (analysis of variance) model on the logarithmic scale included effects accounting for the following sources of variation: 'sequence', 'period' and 'treatment' as fixed effects and 'subjects within sequences' as random effect.~The main focus was on estimation and not on testing, that is, formal statistical hypotheses were not tested."||110.431|105.334|
72433802|NCT01879371|144380827|SUPERIORITY_OR_OTHER||Geometric mean ratio (net)|109.48|||||TWO_SIDED|90.0|107.072|111.936|||||The geometric mean ratio is calculated as the geometric mean of 'Ibuprofen + Caffeine (FDC) tablet ' divided by the geometric mean of ' Ibuprofen lysinate film-coated tablet '.|The ANOVA (analysis of variance) model on the logarithmic scale included effects accounting for the following sources of variation: 'sequence', 'period' and 'treatment' as fixed effects and 'subjects within sequences' as random effect. The main focus was on estimation and not on testing, that is, formal statistical hypotheses were not tested.||111.936|107.072|
72556546|NCT04667338|144644351|SUPERIORITY||||||=|0.3543|||||||Chi-squared|||Civil status||||=0.3543
72433803|NCT01879371|144380828|SUPERIORITY_OR_OTHER||Geometric mean ratio (net)|99.65|||||TWO_SIDED|90.0|93.874|105.776|||||The geometric mean ratio is calculated as the geometric mean of 'Ibuprofen + Caffeine (FDC) tablet ' divided by the geometric mean of ' Ibuprofen acid film-coated tablet '.|The ANOVA (analysis of variance) model on the logarithmic scale included effects accounting for the following sources of variation: 'sequence', 'period' and 'treatment' as fixed effects and 'subjects within sequences' as random effect. The main focus was on estimation and not on testing, that is, formal statistical hypotheses were not tested.||105.776|93.874|
72433804|NCT01879371|144380828|SUPERIORITY_OR_OTHER||Geometric mean ratio (net)|70.42|||||TWO_SIDED|90.0|67.087|73.928|||||The geometric mean ratio is calculated as the geometric mean of 'Ibuprofen + Caffeine (FDC) tablet ' divided by the geometric mean of ' Ibuprofen lysinate film-coated tablet '.|The ANOVA (analysis of variance) model on the logarithmic scale included effects accounting for the following sources of variation: 'sequence', 'period' and 'treatment' as fixed effects and 'subjects within sequences' as random effect. The main focus was on estimation and not on testing, that is, formal statistical hypotheses were not tested.||73.928|67.087|
72433805|NCT01879371|144380829|SUPERIORITY_OR_OTHER||Geometric mean ratio (net)|106.5|||||TWO_SIDED|90.0|104.05|109.004|||||The geometric mean ratio is calculated as the geometric mean of 'Ibuprofen + Caffeine (FDC) tablet ' divided by the geometric mean of ' Ibuprofen acid film-coated tablet '.|The ANOVA (analysis of variance) model on the logarithmic scale included effects accounting for the following sources of variation: 'sequence', 'period' and 'treatment' as fixed effects and 'subjects within sequences' as random effect. The main focus was on estimation and not on testing, that is, formal statistical hypotheses were not tested.||109.004|104.050|
72433806|NCT01879371|144380829|SUPERIORITY_OR_OTHER||Geometric mean ratio (net)|108.59|||||TWO_SIDED|90.0|106.185|111.054|||||The geometric mean ratio is calculated as the geometric mean of 'Ibuprofen + Caffeine (FDC) tablet ' divided by the geometric mean of ' Ibuprofen lysinate film-coated tablet '.|The ANOVA (analysis of variance) model on the logarithmic scale included effects accounting for the following sources of variation: 'sequence', 'period' and 'treatment' as fixed effects and 'subjects within sequences' as random effect. The main focus was on estimation and not on testing, that is, formal statistical hypotheses were not tested.||111.054|106.185|
72433807|NCT03068611|144380831|SUPERIORITY|||||||0.9|||||||Chi-squared|||||||.90
72433808|NCT03068611|144380832|SUPERIORITY|||||||0.54|||||||Chi-squared|||||||.54
72433809|NCT03068611|144380833|SUPERIORITY|||||||0.36|||||||t-test, 2 sided|Data were log-transformed transformed due to positive skewness||||||.36
72493950|NCT01562548|144516794|SUPERIORITY_OR_OTHER||Least Squares Means Difference|0.24||||0.58|TWO_SIDED|95.0|-0.64|1.13||P-value associated with t-test for difference of LS means|t-test, 2 sided||Least Square mean from Mixed Model including factors for treatment (as a fixed effect) and site (as a random effect). Difference was Second named treatment - first named treatment|Null hypotheses was tested as: H01: There was no difference in the mean change from baseline of muscle spasm score between Guaifenesin 600mg and placebo. H02: There was no difference in the mean change from baseline of muscle spasm score between Guaifenesin 1200mg and placebo. H03: There was no difference in the mean change from baseline of muscle spasm score between Guaifenesin 1200mg and Guaifenesin 600mg.||1.13|-0.64|0.58
72556547|NCT04667338|144644351|SUPERIORITY||||||=|0.0368|||||||Chi-squared|||Living conditions||||=0.0368
72556548|NCT04667338|144644351|SUPERIORITY||||||=|0.3512|||||||Chi-squared|||Smoking status||||=0.3512
72556549|NCT04667338|144644351|SUPERIORITY||||||=|0.104|||||||Chi-squared|||Alcohol intake||||=0.1040
72433810|NCT03068611|144380834|SUPERIORITY|||||||0.92|||||||t-test, 2 sided|Data were log-transformed to correct positive skewness||||||.92
72433811|NCT01467700|144380889|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|1.28||0.518|TWO_SIDED|98.0|-2.9|3.1||P-values were from an MMRM model with baseline\*week, pooled center, week, treatment, baseline, and week\*treatment as factors in the analysis.|Mixed Models Analysis|||||3.1|-2.9|0.518
72433812|NCT01467700|144380889|SUPERIORITY_OR_OTHER||LS Mean Difference|2.6|STANDARD_ERROR_OF_MEAN|1.29||0.979|TWO_SIDED|98.0|-0.4|5.7||P-values were from an MMRM model with baseline\*week, pooled center, week, treatment, baseline, and week\*treatment as factors in the analysis.|Mixed Models Analysis|||||5.7|-0.4|0.979
72433813|NCT01467700|144380889|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|1.29||0.4|TWO_SIDED|99.0|-3.7|3.0||P-values were from an MMRM model with baseline\*week, pooled center, week, treatment, baseline, and week\*treatment as factors in the analysis.|Mixed Models Analysis|||||3.0|-3.7|0.400
72433814|NCT01467700|144380890|SUPERIORITY_OR_OTHER||LS Mean Difference|4.7|STANDARD_ERROR_OF_MEAN|2.22||0.017|TWO_SIDED|98.0|-0.5|9.9||P-values were from an MMRM model with baseline\*week, pooled center, week, treatment, baseline, and week\*treatment as factors in the analysis.|Mixed Models Analysis|||||9.9|-0.5|0.017
72433815|NCT01467700|144380890|SUPERIORITY_OR_OTHER||LS Mean Difference|0.8|STANDARD_ERROR_OF_MEAN|2.25||0.361|TWO_SIDED|98.0|-4.5|6.1||P-values were from an MMRM model with baseline\*week, pooled center, week, treatment, baseline, and week\*treatment as factors in the analysis.|Mixed Models Analysis|||||6.1|-4.5|0.361
72433816|NCT01467700|144380890|SUPERIORITY_OR_OTHER||LS Mean Difference|6.4|STANDARD_ERROR_OF_MEAN|2.23||0.002|TWO_SIDED|99.0|0.6|12.1||P-values were from an MMRM model with baseline\*week, pooled center, week, treatment, baseline, and week\*treatment as factors in the analysis.|Mixed Models Analysis|||||12.1|0.6|0.002
72433817|NCT00299702|144380973|SUPERIORITY_OR_OTHER|||||||0.684||||||Hochberg procedure was used for adjusting multiple endpoint comparisons|Log Rank|Insufficient number of subjects who had an event for median estimation.||Null hypothesis: there is no difference in time to relapse||||0.684
72433818|NCT00299702|144380974|SUPERIORITY_OR_OTHER|||||||0.646||||||Hochberg procedure was used for adjusting multiple endpoint comparisons|Wilcoxon (Mann-Whitney)|||Null hypothesis: there is no difference in time in remission between the two treatment groups||||0.646
72433819|NCT05460663|144380979|EQUIVALENCE|Paired Wilcoxon signed ranks tests were used to compare changes at 12-week, 18-week, or 24-week follow-ups from the baseline scores for all measurements in each training modality separately and combined. Comparisons were made with participants who had data at both baseline and the follow-up. Difference-in-difference comparison of changes between two training modalities at each follow-up from the baseline were made to assess differences between CBT and in-person training.||||||0.083||||||The reported P-value is for differences between groups at 24-weeks post-intervention.The Benjamini \& Hochberg adjustment was applied to control for the false-discovery rate among all pairwise pre-post comparisons.|Wilcoxon (Mann-Whitney)|||||||.083
72433820|NCT00762463|144381016|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|LS mean difference calculated as LS mean change for Celecoxib 200 mg once daily minus LS mean change for Diclofenac SR 75 mg once daily. Non-inferiority was declared if the upper bound of the 95% confidence interval was \<10 mm.|LS Mean Difference|3.3|STANDARD_ERROR_OF_MEAN|2.79||0.0085|TWO_SIDED|95.0|-2.2|8.8|||ANCOVA|Analysis of covariance (ANCOVA); factors: treatment group and study center; covariate: baseline Patient's Assessment of Global Pain Intensity score.||"Null hypothesis: Least Squares (LS) mean difference between Celecoxib 200 mg once daily versus Diclofenac SR 75 mg once daily on change in Global Pain Intensity from baseline to Week 6 was at least 10 mm. Corresponding alternative hypothesis: This difference was \<10 mm.~For the non-inferiority test, power was 80% and significance level was 0.025 (1-sided)."||8.8|-2.2|0.0085
72433821|NCT00762463|144381018|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|2.5||0.7849|TWO_SIDED|95.0|-5.6|4.2|||ANCOVA|Change from baseline analyzed using ANCOVA with treatment group and investigational centers as factors and baseline value as a covariate.||Change from baseline to Week 2. The p-value is for the null hypothesis test H0: u1=u2 vs. H1: u1 is not equal to u2.||4.2|-5.6|0.7849
72433822|NCT00762463|144381018|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|2.6|STANDARD_ERROR_OF_MEAN|2.62||0.3223|TWO_SIDED|95.0|-2.6|7.8|||ANCOVA|Change from baseline was analyzed using ANCOVA with treatment group and investigational centers as factors and baseline value as a covariate.||Change from baseline to Week 4. The p-value is for the null hypothesis test H0: u1=u2 vs. H1: u1 is not equal to u2.||7.8|-2.6|0.3223
72433823|NCT00762463|144381020|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.08||0.8938|TWO_SIDED|95.0|-0.15|0.17|||ANCOVA|Change from baseline was analyzed using ANCOVA with treatment group and investigational centers as factors and baseline value as a covariate.||Change from baseline to Week 2. The p-value is for the null hypothesis test H0: u1=u2 vs. H1: u1 is not equal to u2.||0.17|-0.15|0.8938
72433824|NCT00762463|144381020|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|0.08||0.0426|TWO_SIDED|95.0|0.01|0.31|||ANCOVA|Change from baseline was analyzed using ANCOVA with treatment group and investigational centers as factors and baseline value as a covariate.||Change from baseline to Week 4. The p-value is for the null hypothesis test H0: u1=u2 vs. H1: u1 is not equal to u2.||0.31|0.01|0.0426
72433825|NCT00762463|144381020|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.09||0.1502|TWO_SIDED|95.0|-0.05|0.29|||ANCOVA|Change from baseline was analyzed using ANCOVA with treatment group and investigational centers as factors and baseline value as a covariate.||Change from baseline to Week 6. The p-value is for the null hypothesis test H0: u1=u2 vs. H1: u1 is not equal to u2.||0.29|-0.05|0.1502
72493951|NCT01496066|144516808|SUPERIORITY||||||<|0.0001|||||||Chi-squared|||||||<.0001
72493952|NCT01496066|144516809|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||||||<.0001
72556550|NCT04667338|144644351|SUPERIORITY||||||=|0.0202|||||||Chi-squared|||Exercise status||||=0.0202
72556551|NCT04667338|144644351|SUPERIORITY||||||=|0.3503|||||||Chi-squared|||Family history of narcolepsy||||=0.3503
72556552|NCT04667338|144644356|SUPERIORITY||||||=|0.0715|||||||Chi-squared|||General practitioner||||=0.0715
72556553|NCT04667338|144644356|SUPERIORITY||||||=|0.0929|||||||Chi-squared|||Neurologist||||=0.0929
72556554|NCT04667338|144644356|SUPERIORITY||||||=|0.3092|||||||Chi-squared|||Neuropediatrician||||=0.3092
72556555|NCT04667338|144644356|SUPERIORITY||||||=|0.4528|||||||Chi-squared|||Neurophysiologist||||=0.4528
72556556|NCT04667338|144644356|SUPERIORITY||||||<|0.0001|||||||Chi-squared|||Pneumologist||||<0.0001
72433826|NCT00762463|144381022|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.07||0.5945|TWO_SIDED|95.0|-0.2|0.1|||ANCOVA|Change from baseline was analyzed using ANCOVA with treatment group and investigational centers as factors and baseline value as a covariate.||Change from baseline to Week 2. The p-value is for the null hypothesis test H0: u1=u2 vs. H1: u1 is not equal to u2.||0.1|-0.2|0.5945
72433827|NCT00762463|144381022|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.07||0.3427|TWO_SIDED|95.0|-0.1|0.2|||ANCOVA|Change from baseline was analyzed using ANCOVA with treatment group and investigational centers as factors and baseline value as a covariate.||Change from baseline to Week 4. The p-value is for the null hypothesis test H0: u1=u2 vs. H1: u1 is not equal to u2.||0.2|-0.1|0.3427
72433828|NCT00762463|144381022|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.08||0.6522|TWO_SIDED|95.0|-0.1|0.2|||ANCOVA|Change from baseline was analyzed using ANCOVA with treatment group and investigational centers as factors and baseline value as a covariate.||Change from baseline to Week 6. The p-value is for the null hypothesis test H0: u1=u2 vs. H1: u1 is not equal to u2.||0.2|-0.1|0.6522
72433829|NCT00762463|144381024|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.18||0.9358|TWO_SIDED|95.0|-0.3|0.4|||ANCOVA|Change from baseline was analyzed using ANCOVA with treatment group and investigational centers as factors and baseline value as a covariate.||Change from baseline to Week 2. The p-value is for the null hypothesis test H0: u1=u2 vs. H1: u1 is not equal to u2.||0.4|-0.3|0.9358
72433830|NCT00762463|144381024|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.2||0.5916|TWO_SIDED|95.0|-0.3|0.5|||ANCOVA|Change from baseline was analyzed using ANCOVA with treatment group and investigational centers as factors and baseline value as a covariate.||Change from baseline to Week 4. The p-value is for the null hypothesis test H0: u1=u2 vs. H1: u1 is not equal to u2.||0.5|-0.3|0.5916
72433831|NCT00762463|144381024|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|0.2||0.179|TWO_SIDED|95.0|-0.1|0.7|||ANCOVA|Change from baseline was analyzed using ANCOVA with treatment group and investigational centers as factors and baseline value as a covariate.||Change from baseline to Week 6. The p-value is for the null hypothesis test H0: u1=u2 vs. H1: u1 is not equal to u2.||0.7|-0.1|0.1790
72433832|NCT00762463|144381026|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.2||0.6335|TWO_SIDED|95.0|-0.3|0.5|||ANCOVA|Change from baseline was analyzed using ANCOVA with treatment group and investigational centers as factors and baseline value as a covariate.||Change from baseline to Week 2. The p-value is for the null hypothesis test H0: u1=u2 vs. H1: u1 is not equal to u2.||0.5|-0.3|0.6335
72433833|NCT00762463|144381026|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|0.21||0.2729|TWO_SIDED|95.0|-0.2|0.6|||ANCOVA|Change from baseline was analyzed using ANCOVA with treatment group and investigational centers as factors and baseline value as a covariate.||Change from baseline to Week 4. The p-value is for the null hypothesis test H0: u1=u2 vs. H1: u1 is not equal to u2.||0.6|-0.2|0.2729
72433834|NCT00762463|144381026|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|0.22||0.1559|TWO_SIDED|95.0|-0.1|0.8|||ANCOVA|Change from baseline was analyzed using ANCOVA with treatment group and investigational centers as factors and baseline value as a covariate.||Change from baseline to Week 6. The p-value is for the null hypothesis test H0: u1=u2 vs. H1: u1 is not equal to u2.||0.8|-0.1|0.1559
72433835|NCT00762463|144381029|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|4.3|STANDARD_ERROR_OF_MEAN|2.67||0.1111|TWO_SIDED|95.0|-1.0|9.5|||ANCOVA|Change from baseline was analyzed using ANCOVA with treatment group and investigational centers as factors and baseline value as a covariate.||Change from baseline to Week 2. The p-value is for the null hypothesis test H0: u1=u2 vs. H1: u1 is not equal to u2.||9.5|-1.0|0.1111
72556557|NCT04667338|144644356|SUPERIORITY||||||=|0.1785|||||||Chi-squared|||Somnologist||||=0.1785
72433836|NCT00762463|144381029|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|2.5|STANDARD_ERROR_OF_MEAN|2.74||0.3574|TWO_SIDED|95.0|-2.9|7.9|||ANCOVA|Change from baseline was analyzed using ANCOVA with treatment group and investigational centers as factors and baseline value as a covariate.||Change from baseline to Week 4. The p-value is for the null hypothesis test H0: u1=u2 vs. H1: u1 is not equal to u2.||7.9|-2.9|0.3574
72433837|NCT00762463|144381029|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|4.0|STANDARD_ERROR_OF_MEAN|2.76||0.1464|TWO_SIDED|95.0|-1.4|9.5|||ANCOVA|Change from baseline was analyzed using ANCOVA with treatment group and investigational centers as factors and baseline value as a covariate.||Change from baseline to Week 6. The p-value is for the null hypothesis test H0: u1=u2 vs. H1: u1 is not equal to u2.||9.5|-1.4|0.1464
72433838|NCT00762463|144381031|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.87||0.9641|TWO_SIDED|95.0|-1.7|1.8|||ANCOVA|Change from baseline was analyzed using ANCOVA with treatment group and investigational centers as factors and baseline value as a covariate.||Change from baseline to Week 2. The p-value is for the null hypothesis test H0: u1=u2 vs. H1: u1 is not equal to u2.||1.8|-1.7|0.9641
72433839|NCT00762463|144381031|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|0.98||0.7749|TWO_SIDED|95.0|-1.6|2.2|||ANCOVA|Change from baseline was analyzed using ANCOVA with treatment group and investigational centers as factors and baseline value as a covariate.||Change from baseline to Week 4. The p-value is for the null hypothesis test H0: u1=u2 vs. H1: u1 is not equal to u2.||2.2|-1.6|0.7749
72433840|NCT00762463|144381031|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|0.95||0.7529|TWO_SIDED|95.0|-1.6|2.2|||ANCOVA|Change from baseline was analyzed using ANCOVA with treatment group and investigational centers as factors and baseline value as a covariate.||Change from baseline to Week 6. The p-value is for the null hypothesis test H0: u1=u2 vs. H1: u1 is not equal to u2.||2.2|-1.6|0.7529
72433841|NCT00762463|144381033|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.11||0.878|TWO_SIDED|95.0|-0.2|0.2|||ANCOVA|Change from baseline was analyzed using ANCOVA with treatment group and investigational centers as factors and baseline value as a covariate.||Change from baseline to Week 2. The p-value is for the null hypothesis test H0: u1=u2 vs. H1: u1 is not equal to u2.||0.2|-0.2|0.8780
72493953|NCT01496066|144516810|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||||||<.0001
72493954|NCT01496066|144516811|SUPERIORITY|||||||0.0318|||||||t-test, 2 sided|||||||.0318
72556558|NCT04667338|144644356|SUPERIORITY||||||=|0.1474|||||||Chi-squared|||Somnologist-unit||||=0.1474
72556559|NCT04667338|144644357|SUPERIORITY||||||=|0.2042|||||||Chi-squared|||Clinical history||||=0.2042
72556560|NCT04667338|144644357|SUPERIORITY||||||=|0.5818|||||||Chi-squared|||Clinical assessment: ESS||||=0.5818
72433842|NCT00762463|144381033|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|0.13||0.2202|TWO_SIDED|95.0|-0.1|0.4|||ANCOVA|Change from baseline was analyzed using ANCOVA with treatment group and investigational centers as factors and baseline value as a covariate.||Change from baseline to Week 4. The p-value is for the null hypothesis test H0: u1=u2 vs. H1: u1 is not equal to u2.||0.4|-0.1|0.2202
72433843|NCT00762463|144381033|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.14||0.534|TWO_SIDED|95.0|-0.2|0.4|||ANCOVA|Change from baseline was analyzed using ANCOVA with treatment group and investigational centers as factors and baseline value as a covariate.||Change from baseline to Week 6. The p-value is for the null hypothesis test H0: u1=u2 vs. H1: u1 is not equal to u2.||0.4|-0.2|0.5340
72433844|NCT00762463|144381035|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|1.81||0.7003|TWO_SIDED|95.0|-4.3|2.9|||ANCOVA|Change from baseline analyzed using ANCOVA with treatment group and investigational centers as factors and baseline value as a covariate.||The p-value is for the null hypothesis test H0: u1=u2 vs. H1: u1 is not equal to u2.||2.9|-4.3|0.7003
72433845|NCT00762463|144381037|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.44|STANDARD_ERROR_OF_MEAN|2.221||0.5183|TWO_SIDED|95.0|-5.82|2.94|||ANCOVA|Change from baseline analyzed using ANCOVA with treatment group and investigational centers as factors and baseline value as a covariate.||The p-value is for the null hypothesis test H0: u1=u2 vs. H1: u1 is not equal to u2.||2.94|-5.82|0.5183
72433846|NCT01306331|144381042|NON_INFERIORITY|If the upper bound for the confidence interval of the difference was \< 5.5, then the null hypothesis would be rejected.|Mean Difference (Final Values)|0.5|||||TWO_SIDED|95.0|-2.2|3.2||||||The primary hypothesis test was performed using 95% confidence interval for the difference in cumulative pregnancy rates between the treatment arms. If the upper bound for the confidence interval of the difference was \< 5.5, then the null hypothesis would be rejected.||3.2|-2.2|
72433847|NCT00151996|144381077|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||t-test, 2 sided|||Change from baseline in ADHD-RS-IV total score||||<0.0001
72433848|NCT00151996|144381077|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||t-test, 2 sided|||Change from baseline in ADHD-RS-IV total score||||<0.0001
72433849|NCT00151996|144381079|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||t-test, 2 sided|||Change from baseline in CPRS-R total score||||<0.0001
72433850|NCT00151996|144381079|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0002||95.0|||||t-test, 2 sided|||Change from baseline in CPRS-R total score||||0.0002
72433851|NCT00151996|144381081|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7004||95.0|||||t-test, 2 sided|||Change in physical summary score||||0.7004
72433852|NCT00151996|144381081|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||t-test, 2 sided|||Change in psychosocial summary score||||<0.0001
72433853|NCT00151996|144381081|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9257||95.0|||||t-test, 2 sided|||Change in physical summary score||||0.9257
72433854|NCT00151996|144381081|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||t-test, 2 sided|||Change in psychosocial summary score||||<0.0001
72433855|NCT01167426|144381182|SUPERIORITY_OR_OTHER||Difference in mean ranks|79.6|||<|0.0001||95.0|||||Wilcoxon Signed-Rank||Difference in mean ranks between Week 2 and Week 6|Comparison of Week 2 (20 mg/1.0 mL utilizing autoject 2 for glass syringe) to Week 6 (20 mg/0.5 mL utilizing the autoject 2 20 mg/0.5 mL).||||<0.0001
72433856|NCT01167426|144381183|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Goodness-of-fit p-value comparing overall preference to expected frequencies of 33.3% in each category. That is, no preference across the full sample of patients in the study.|Chi-squared|||||||<0.0001
72433857|NCT01859312|144381189|OTHER|||||||0.021|||||||t-test, 2 sided|||Comparisons of CSHI (at 6 months) with conventional glucocorticoid therapy (at baseline) were made. Continuous data between baseline and 6 months were compared by paired t tests.||||0.021
72433858|NCT01859312|144381191|OTHER|||||||0.027|||||||t-test, 2 sided|||Comparisons of CSHI (at 6 months) with conventional glucocorticoid therapy (at baseline) were made. Continuous data between baseline and 6 months were compared by paired t tests.||||0.027
72433859|NCT01859312|144381193|OTHER|||||||0.008|||||||t-test, 2 sided|||Comparisons of CSHI (at 6 months) with conventional glucocorticoid therapy (at baseline) were made. Continuous data between baseline and 6 months were compared by paired t tests.||||0.008
72433860|NCT01859312|144381195|OTHER|||||||0.012|||||||t-test, 2 sided|||Comparisons of CSHI (at 6 months) with conventional glucocorticoid therapy (at baseline) were made. Continuous data between baseline and 6 months were compared by paired t tests.||||0.012
72433861|NCT01859312|144381197|OTHER|||||||0.157|||||||t-test, 2 sided|||Comparisons of CSHI (at 6 months) with conventional glucocorticoid therapy (at baseline) were made. Continuous data between baseline and 6 months were compared by paired t tests.||||0.157
72433862|NCT01859312|144381199|OTHER|||||||0.015|||||||t-test, 2 sided|||Comparisons of CSHI (at 6 months) with conventional glucocorticoid therapy (at baseline) were made. Continuous data between baseline and 6 months were compared by paired t tests.||||0.015
72433863|NCT01859312|144381201|OTHER|||||||0.009|||||||t-test, 2 sided|||Comparisons of CSHI (at 6 months) with conventional glucocorticoid therapy (at baseline) were made. Continuous data between baseline and 6 months were compared by paired t tests.||||0.009
72433864|NCT01859312|144381203|OTHER|||||||0.008|||||||t-test, 2 sided|||Comparisons of CSHI (at 6 months) with conventional glucocorticoid therapy (at baseline) were made. Continuous data between baseline and 6 months were compared by paired t tests.||||0.008
72433865|NCT01859312|144381205|OTHER|||||||0.009|||||||t-test, 2 sided|||Comparisons of CSHI (at 6 months) with conventional glucocorticoid therapy (at baseline) were made. Continuous data between baseline and 6 months were compared by paired t tests.||||0.009
72433866|NCT01859312|144381207|OTHER|||||||0.043|||||||t-test, 2 sided|||Comparisons of CSHI (at 6 months) with conventional glucocorticoid therapy (at baseline) were made. Continuous data between baseline and 6 months were compared by paired t tests.||||0.043
72433867|NCT01859312|144381209|OTHER|||||||0.024|||||||t-test, 2 sided|||Comparisons of CSHI (at 6 months) with conventional glucocorticoid therapy (at baseline) were made. Continuous data between baseline and 6 months were compared by paired t tests.||||0.024
72433868|NCT01859312|144381211|OTHER|||||||0.031|||||||t-test, 2 sided|||Comparisons of CSHI (at 6 months) with conventional glucocorticoid therapy (at baseline) were made. Continuous data between baseline and 6 months were compared by paired t tests.||||0.031
72433869|NCT01859312|144381213|OTHER|||||||0.005|||||||t-test, 2 sided|||Comparisons of CSHI (at 6 months) with conventional glucocorticoid therapy (at baseline) were made. Continuous data between baseline and 6 months were compared by paired t tests.||||0.005
72556561|NCT04667338|144644357|SUPERIORITY||||||=|0.0368|||||||Chi-squared|||Neurological assessment||||=0.0368
72381415|NCT00395538|144271232|OTHER|A contrast statement within the mixed models analysis tested for differences in the Cn.MAR between the baseline and the years 2 and 4 (combined) biopsy.||||||0.004||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Cn.MAR at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.004
72381416|NCT00395538|144271232|OTHER|A contrast statement within the mixed models analysis tested for differences in the Cn.MAR between the year 1 biopsy and the years 2 and 4 (combined) biopsy.||||||0.904||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Cn.MAR at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.904
72381417|NCT00395538|144271233|OTHER|A contrast statement within the mixed models analysis tested for differences in the Cn.OS/BS between the baseline and the year 1 biopsy.||||||0.002||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Cn.OS/BS at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.002
72381418|NCT00395538|144271233|OTHER|A contrast statement within the mixed models analysis tested for differences in the Cn.OS/BS between the baseline and the years 2 and 4 (combined) biopsy.|||||<|0.001||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Cn.OS/BS at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||<0.001
72381419|NCT00395538|144271233|OTHER|A contrast statement within the mixed models analysis tested for differences in the Cn.OS/BS between the year 1 biopsy and the years 2 and 4 (combined) biopsy.||||||0.01||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Cn.OS/BS at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.010
72381420|NCT00395538|144271234|OTHER|A contrast statement within the mixed models analysis tested for differences in the Cn.ES/BS between the baseline and the year 1 biopsy.||||||0.001||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Cn.ES/BS at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.001
72433870|NCT01859312|144381215|OTHER|||||||0.004|||||||t-test, 2 sided|||Comparisons of CSHI (at 6 months) with conventional glucocorticoid therapy (at baseline) were made. Continuous data between baseline and 6 months were compared by paired t tests.||||0.004
72433871|NCT01859312|144381217|OTHER|||||||0.524|||||||t-test, 2 sided|||Comparisons of CSHI (at 6 months) with conventional glucocorticoid therapy (at baseline) were made. Continuous data between baseline and 6 months were compared by paired t tests.||||0.524
72433872|NCT01859312|144381219|OTHER|||||||0.007|||||||t-test, 2 sided|||Comparisons of CSHI (at 6 months) with conventional glucocorticoid therapy (at baseline) were made. Continuous data between baseline and 6 months were compared by paired t tests.|Comparison of hormone levels on conventional glucocorticoid therapy at baseline and following 6 months of CSHI.|||0.007
72433873|NCT01859312|144381221|OTHER|||||||0.084|||||||t-test, 2 sided|||Comparisons of CSHI (at 6 months) with conventional glucocorticoid therapy (at baseline) were made. Continuous data between baseline and 6 months were compared by paired t tests.||||0.084
72556562|NCT04667338|144644357|SUPERIORITY||||||=|0.1128|||||||Chi-squared|||MSLT||||=0.1128
72556563|NCT04667338|144644357|SUPERIORITY||||||=|0.3396|||||||Chi-squared|||AHI||||=0.3396
72556564|NCT04667338|144644357|SUPERIORITY||||||=|0.6794|||||||Chi-squared|||Other procedures||||=0.6794
72556565|NCT04667338|144644357|SUPERIORITY||||||=|0.0138|||||||Chi-squared|||HLA typing||||=0.0138
72556566|NCT04667338|144644357|SUPERIORITY||||||=|0.0597|||||||Chi-squared|||Hypocretin-1 CSF or Orexin||||=0.0597
72556567|NCT04667338|144644358|SUPERIORITY||||||=|0.1171|||||||t-test, 2 sided|||||||=0.1171
72556568|NCT04667338|144644359|SUPERIORITY||||||=|0.3834|||||||t-test, 2 sided|||||||=0.3834
72433874|NCT01859312|144381223|OTHER|||||||0.057|||||||t-test, 2 sided|||Comparisons of CSHI (at 6 months) with conventional glucocorticoid therapy (at baseline) were made. Continuous data between baseline and 6 months were compared by paired t tests.||||0.057
72433875|NCT01859312|144381225|OTHER|||||||0.103|||||||t-test, 2 sided|||Comparisons of CSHI (at 6 months) with conventional glucocorticoid therapy (at baseline) were made. Continuous data between baseline and 6 months were compared by paired t tests.||||0.103
72433876|NCT01859312|144381227|OTHER|||||||0.07|||||||t-test, 2 sided|||Comparisons of CSHI (at 6 months) with conventional glucocorticoid therapy (at baseline) were made. Continuous data between baseline and 6 months were compared by paired t tests.||||0.070
72433877|NCT05824351|144381259|EQUIVALENCE|Equivalence is defined as an average difference of \< or = 2|Mean of paired differences|-0.2571|STANDARD_DEVIATION|0.7|<|0.0001|TWO_SIDED||||||t-test, 1 sided|One-sided lower t-test||Draize scores for erythema/eschar and edema were summed for analysis (range of 0 to 8, where a higher score indicated greater irritation).||||<0.0001
72433878|NCT05824351|144381259|EQUIVALENCE|Equivalence is defined as an average difference of \< or = 2|Mean of paired differences|0.0294|STANDARD_DEVIATION|0.79||0.0003|TWO_SIDED||||||t-test, 1 sided|One-sided upper t-test||Draize scores for erythema/eschar and edema were summed for analysis (range of 0 to 8, where a higher score indicated greater irritation).||||0.0003
72433879|NCT02929069|144381333|SUPERIORITY||Risk Ratio (RR)|0.88||||0.52|TWO_SIDED|95.0|0.52|1.25|||Regression, Logistic|||||1.25|.52|0.52
72433880|NCT00813488|144381393|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.13|STANDARD_ERROR_OF_MEAN|0.09||0.0004|TWO_SIDED|95.0|0.06|0.2|||Mixed effects ANOVA crossover model|||The statistical hypothesis to be tested was: HO: µFBT = µOXY versus Ha: µFBT ≠ µoxy where µFBT and µOXY denote the mean PID15 for double-blind episodes for which patients use FBT and OXY, respectively. The primary variable was analyzed using a mixed effects ANOVA crossover model, with treatment as randomized (FBT or OXY), period, and treatment sequence (as randomized) as fixed factors and patient as a random factor, using compound symmetry for the variance-covariance matrix.||0.20|0.06|0.0004
72433881|NCT00813488|144381394|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.02||0.2242|TWO_SIDED|95.0|-0.01|0.05||LS mean, SE of LS mean and p-value for treatment comparison are from ANOVA based on individual episodes with treatment as randomized, phase, and sequence as fixed factors and patient as random factor, using compound symmetry.|ANOVA|||The statistical hypothesis to be tested was: HO: µFBT = µOXY versus Ha: µFBT ≠ µoxy where µFBT and µOXY denote the mean PID5 for double-blind episodes for which patients use FBT and OXY, respectively. The primary variable was analyzed using a mixed effects ANOVA crossover model, with treatment as randomized (FBT or OXY), period, and treatment sequence (as randomized) as fixed factors and patient as a random factor, using compound symmetry for the variance-covariance matrix.||.05|-0.01|0.2242
72433882|NCT00813488|144381395|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.06|STANDARD_ERROR_OF_MEAN|0.05||0.0106|TWO_SIDED|95.0|0.01|0.11||LS mean, SE of LS mean and p-value for treatment comparison are from ANOVA based on individual episodes with treatment as randomized, phase, and sequence as fixed factors and patient as random factor, using compound symmetry.|ANOVA|||The statistical hypothesis to be tested was: HO: µFBT = µOXY versus Ha: µFBT ≠ µoxy where µFBT and µOXY denote the mean PID10 for double-blind episodes for which patients use FBT and OXY, respectively. The primary variable was analyzed using a mixed effects ANOVA crossover model, with treatment as randomized (FBT or OXY), period, and treatment sequence (as randomized) as fixed factors and patient as a random factor, using compound symmetry for the variance-covariance matrix.||.11|0.01|0.0106
72433883|NCT00813488|144381396|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|0.21|0.4||LS mean, SE of LS mean and p-value for treatment comparison are from ANOVA based on individual episodes with treatment as randomized, phase, and sequence as fixed factors and patient as random factor, using compound symmetry.|ANOVA|||The statistical hypothesis to be tested was: HO: µFBT = µOXY versus Ha: µFBT ≠ µoxy where µFBT and µOXY denote the mean PID30 for double-blind episodes for which patients use FBT and OXY, respectively. The primary variable was analyzed using a mixed effects ANOVA crossover model, with treatment as randomized (FBT or OXY), period, and treatment sequence (as randomized) as fixed factors and patient as a random factor, using compound symmetry for the variance-covariance matrix.||.40|.21|<0.0001
72433884|NCT00813488|144381397|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.28|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|0.18|0.37||LS mean, SE of LS mean and p-value for treatment comparison are from ANOVA based on individual episodes with treatment as randomized, phase, and sequence as fixed factors and patient as random factor, using compound symmetry.|ANOVA|||The statistical hypothesis to be tested was: HO: µFBT = µOXY versus Ha: µFBT ≠ µoxy where µFBT and µOXY denote the mean PID45 for double-blind episodes for which patients use FBT and OXY, respectively. The primary variable was analyzed using a mixed effects ANOVA crossover model, with treatment as randomized (FBT or OXY), period, and treatment sequence (as randomized) as fixed factors and patient as a random factor, using compound symmetry for the variance-covariance matrix.||.37|0.18|<0.0001
72433885|NCT00813488|144381398|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.17|STANDARD_ERROR_OF_MEAN|0.15||0.0002|TWO_SIDED|95.0|0.08|0.27||LS mean, SE of LS mean and p-value for treatment comparison are from ANOVA based on individual episodes with treatment as randomized, phase, and sequence as fixed factors and patient as random factor, using compound symmetry.|ANOVA|||The statistical hypothesis to be tested was: HO: µFBT = µOXY versus Ha: µFBT ≠ µoxy where µFBT and µOXY denote the mean PID60 for double-blind episodes for which patients use FBT and OXY, respectively. The primary variable was analyzed using a mixed effects ANOVA crossover model, with treatment as randomized (FBT or OXY), period, and treatment sequence (as randomized) as fixed factors and patient as a random factor, using compound symmetry for the variance-covariance matrix.||0.27|0.08|0.0002
72433886|NCT00813488|144381405|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.37|||<|0.0001|TWO_SIDED|95.0|0.25|0.5|||ANOVA|||||0.50|0.25|<0.0001
72556569|NCT04667338|144644364|SUPERIORITY||||||=|0.0531|||||||t-test, 2 sided|||||||=0.0531
72433887|NCT00813488|144381406|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.82|||<|0.0001|TWO_SIDED|95.0|0.55|1.1|||ANOVA|||||1.10|.55|<0.0001
72556570|NCT04667338|144644365|SUPERIORITY||||||=|0.0005|||||||Chi-squared|||Take short naps||||=0.0005
72556571|NCT04667338|144644365|SUPERIORITY||||||=|0.8221|||||||Chi-squared|||Maintain a regular sleep schedule||||=0.8221
72556572|NCT04667338|144644365|SUPERIORITY||||||=|0.2291|||||||Chi-squared|||Avoid caffeine or alcohol before bedtime||||=0.2291
72433888|NCT00813488|144381407|SUPERIORITY_OR_OTHER|||||||0.5575|||||||Wilcoxon (Mann-Whitney)|P-value for the treatment comparison is from a one-sample Wilcoxon signed rank test.||||||0.5575
72433889|NCT00813488|144381408|SUPERIORITY_OR_OTHER|||||||0.0981|||||||Wilcoxon (Mann-Whitney)|P-value for the treatment comparison is from a one-sample Wilcoxon signed rank test.||||||0.0981
72433890|NCT00813488|144381409|SUPERIORITY_OR_OTHER|||||||0.0443|||||||Wilcoxon (Mann-Whitney)|P-value for the treatment comparison is from a one-sample Wilcoxon signed rank test.||||||0.0443
72433891|NCT00813488|144381410|SUPERIORITY_OR_OTHER|||||||0.0004|||||||Wilcoxon (Mann-Whitney)|P-value for the treatment comparison is from a one-sample Wilcoxon signed rank test.||||||0.0004
72433892|NCT00813488|144381411|SUPERIORITY_OR_OTHER|||||||0.0001|||||||Wilcoxon (Mann-Whitney)|P-value for the treatment comparison is from a one-sample Wilcoxon signed rank test.||||||0.0001
72433893|NCT00813488|144381412|SUPERIORITY_OR_OTHER|||||||0.0018|||||||Wilcoxon (Mann-Whitney)|P-value for the treatment comparison is from a one-sample Wilcoxon signed rank test.||||||0.0018
72433894|NCT00813488|144381413|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.74|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001||95.0|0.58|0.9||LS mean, SE of LS mean and p-value for treatment comparison are from ANOVA based on individual episodes with treatment as randomized, phase, and sequence as fixed factors and patient as random factor, using compound symmetry.|ANOVA|||||0.90|0.58|<0.0001
72433895|NCT00813488|144381415|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.1464||||0.7012|TWO_SIDED|95.0|0.6|2.3|||Generalized Estimating Equation|||Analysis is based on a generalized estimating equation model with treatment as a fixed effect and patient as a random effect. A logit link function and compound symmetry working correlation were applied in this model.||2.3|0.6|0.7012
72433896|NCT00813488|144381416|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.0704||||0.6545|TWO_SIDED|95.0|0.8|1.4|||Generalized Estimating Equation|||Analysis is based on a generalized estimating equation model with treatment as a fixed effect and patient as a random effect. A logit link function and compound symmetry working correlation were applied in this model.||1.4|0.8|0.6545
72433897|NCT00813488|144381417|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.2544||||0.0407|TWO_SIDED|95.0|1.0|1.6|||Generalized Estimating Equation|||Analysis is based on a generalized estimating equation model with treatment as a fixed effect and patient as a random effect. A logit link function and compound symmetry working correlation were applied in this model.||1.6|1.0|0.0407
72433898|NCT00813488|144381418|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.5745||||0.0007|TWO_SIDED|95.0|1.2|2.0|||Generalized Estimating Equation|||Analysis is based on a generalized estimating equation model with treatment as a fixed effect and patient as a random effect. A logit link function and compound symmetry working correlation were applied in this model.||2.0|1.2|0.0007
72433899|NCT00813488|144381419|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.5828||||0.0372|TWO_SIDED|95.0|1.0|2.4|||Generalized Estimating Equation|||Analysis is based on a generalized estimating equation model with treatment as a fixed effect and patient as a random effect. A logit link function and compound symmetry working correlation were applied in this model.||2.4|1.0|0.0372
72433900|NCT00813488|144381420|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.3722||||0.3099|TWO_SIDED|95.0|0.7|2.5|||Generalized Estimating Equation|||Analysis is based on a generalized estimating equation model with treatment as a fixed effect and patient as a random effect. A logit link function and compound symmetry working correlation were applied in this model.||2.5|0.7|0.3099
72433901|NCT00813488|144381421|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.8434||||0.5777|TWO_SIDED|95.0|0.5|1.5|||Generalized Estimating Equation|||Analysis is based on a generalized estimating equation model with treatment as a fixed effect and patient as a random effect. A logit link function and compound symmetry working correlation were applied in this model.||1.5|.5|0.5777
72433902|NCT00813488|144381422|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.986||||0.9567|TWO_SIDED|95.0|0.6|1.6|||Generalized Estimating Equation|||Analysis is based on a generalized estimating equation model with treatment as a fixed effect and patient as a random effect. A logit link function and compound symmetry working correlation were applied in this model.||1.6|0.6|0.9567
72433903|NCT00813488|144381423|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.1366||||0.4253|TWO_SIDED|95.0|0.8|1.6|||Generalized Estimating Equation|||Analysis is based on a generalized estimating equation model with treatment as a fixed effect and patient as a random effect. A logit link function and compound symmetry working correlation were applied in this model.||1.6|0.8|0.4253
72433904|NCT00813488|144381424|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.4269||||0.0038|TWO_SIDED|95.0|1.1|1.8|||Generalized Estimating Equation|||Analysis is based on a generalized estimating equation model with treatment as a fixed effect and patient as a random effect. A logit link function and compound symmetry working correlation were applied in this model.||1.8|1.1|0.0038
72433905|NCT00813488|144381425|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.5118||||0.0012||95.0|1.2|1.9|||Generalized Estimating Equation|||Analysis is based on a generalized estimating equation model with treatment as a fixed effect and patient as a random effect. A logit link function and compound symmetry working correlation were applied in this model.||1.9|1.2|0.0012
72433906|NCT00813488|144381426|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.5826||||0.0074|TWO_SIDED|95.0|1.1|2.2|||Generalized Estimating Equation|||Analysis is based on a generalized estimating equation model with treatment as a fixed effect and patient as a random effect. A logit link function and compound symmetry working correlation were applied in this model.||2.2|1.1|0.0074
72433907|NCT00813488|144381427|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.059||||0.8444|TWO_SIDED|95.0|0.6|1.9|||Generalized Estimating Equation|||Analysis is based on a generalized estimating equation model with treatment as a fixed effect and patient as a random effect. A logit link function and compound symmetry working correlation were applied in this model.||1.9|0.6|0.8444
72433908|NCT00813488|144381428|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.6033|||<|0.0001|TWO_SIDED|95.0|1.4|1.8|||Generalized Estimating Equation|||Analysis is based on a generalized estimating equation model with treatment as a fixed effect and patient as a random effect. A cumulative logit link function and independent working correlation were applied in this model. Treatment differences for each time point were measured across all categories of responses.||1.8|1.4|<0.0001
72433909|NCT00813488|144381429|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.3334|||<|0.0001|TWO_SIDED|95.0|1.2|1.5|||Generalized Estimating Equation|||Analysis is based on a generalized estimating equation model with treatment as a fixed effect and patient as a random effect. A cumulative logit link function and independent working correlation were applied in this model. Treatment differences for each time point were measured across all categories of responses.||1.5|1.2|<0.0001
72493955|NCT01496066|144516812|EQUIVALENCE|a two-group t-test of equivalence in means was used|Mean Difference (Final Values)|-0.04|||||TWO_SIDED|99.0|-0.06|-0.02||||||||-0.02|-0.06|
72381421|NCT00395538|144271234|OTHER|A contrast statement within the mixed models analysis tested for differences in the Cn.ES/BS between the baseline and the years 2 and 4 (combined) biopsy.|||||<|0.001||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Cn.ES/BS at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||<0.001
72381422|NCT00395538|144271234|OTHER|A contrast statement within the mixed models analysis tested for differences in the Cn.ES/BS between the year 1 biopsy and the years 2 and 4 (combined) biopsy.||||||0.02||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Cn.ES/BS at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.020
72381423|NCT00395538|144271235|OTHER|A contrast statement within the mixed models analysis tested for differences in the Cn.AjAR between the baseline and the year 1 biopsy.||||||0.002||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Cn.AjAR at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.002
72381424|NCT00395538|144271235|OTHER|A contrast statement within the mixed models analysis tested for differences in the Cn.AjAR between the baseline and the years 2 and 4 (combined) biopsy.||||||0.022||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Cn.AjAR at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.022
72381425|NCT00395538|144271235|OTHER|A contrast statement within the mixed models analysis tested for differences in the Cn.AjAR between the year 1 biopsy and the years 2 and 4 (combined) biopsy.||||||0.228||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Cn.AjAR at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.228
72381426|NCT00395538|144271236|OTHER|A contrast statement within the mixed models analysis tested for differences in the Ec.O.Th between the baseline and the year 1 biopsy. P-value interpretation is questionable since there were only 4 participants with non-missing Ec.O.Th values for both their baseline and year 1 biopsies.||||||0.004||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ec.O.Th at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.004
72433910|NCT00635817|144381466|SUPERIORITY_OR_OTHER|||||||0.099||||||There were no adjustments for multiple comparisons.|t-test, 2 sided|||Summary statistics were calculated and tests of significance of the change versus no change were performed.||||0.099
72433911|NCT00635817|144381466|SUPERIORITY_OR_OTHER|||||||0.074||||||There were no adjustments for multiple comparisons.|t-test, 2 sided|||Summary statistics were calculated and tests of significance of the change versus no change were performed.||||0.074
72433912|NCT00635817|144381466|SUPERIORITY_OR_OTHER|||||||0.026||95.0||||There were no adjustments for multiple comparisons.|t-test, 2 sided|||Summary statistics were calculated and tests of significance of the change versus no change were performed.||||0.026
72433913|NCT00635817|144381466|SUPERIORITY_OR_OTHER|||||||0.102||95.0||||There were no adjustments for multiple comparisons.|t-test, 2 sided|||Summary statistics were calculated and tests of significance of the change versus no change were performed.||||0.102
72433914|NCT00635817|144381467|SUPERIORITY_OR_OTHER|||||||0.008||||||There were no adjustments for multiple comparisons.|Wilcoxon (Mann-Whitney)|||Summary statistics were calculated and tests of significance of the ratio versus 1 were performed. All analyses and summaries were conducted separately for the 2 treatment groups (subjects who received leuprolide acetate depot 11.25 mg and 30 mg).||||0.008
72433915|NCT00635817|144381467|SUPERIORITY_OR_OTHER|||||||0.002||||||There were no adjustments for multiple comparisons.|Wilcoxon (Mann-Whitney)|||Summary statistics were calculated and tests of significance of the ratio versus 1 were performed. All analyses and summaries were conducted separately for the 2 treatment groups (subjects who received leuprolide acetate depot 11.25 mg and 30 mg).||||0.002
72381427|NCT00395538|144271236|OTHER|A contrast statement within the mixed models analysis tested for differences in the Ec.O.Th between the baseline and the years 2 and 4 (combined) biopsy.||||||0.006||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ec.O.Th at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.006
72381428|NCT00395538|144271236|OTHER|A contrast statement within the mixed models analysis tested for differences in the Ec.O.Th between the year 1 biopsy and the years 2 and 4 (combined) biopsy.||||||0.67||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ec.O.Th at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.670
72381429|NCT00395538|144271237|OTHER|A contrast statement within the mixed models analysis tested for differences in the Ec.MAR between the baseline and the year 1 biopsy. P-value interpretation is questionable since there were only 4 participants with non-missing Ec.MAR values for both their baseline and year 1 biopsies.||||||0.003||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ec.MAR at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.003
72381430|NCT00395538|144271237|OTHER|A contrast statement within the mixed models analysis tested for differences in the Ec.MAR between the baseline and the years 2 and 4 (combined) biopsy.||||||0.001||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ec.MAR at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.001
72381431|NCT00395538|144271237|OTHER|A contrast statement within the mixed models analysis tested for differences in the Ec.MAR between the year 1 biopsy and the years 2 and 4 (combined) biopsy.||||||0.712||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ec.MAR at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.712
72381432|NCT00395538|144271238|OTHER|A contrast statement within the mixed models analysis tested for differences in the Ec.OS/BS between the baseline and the year 1 biopsy. P-value interpretation is questionable since there were only 4 participants with non-missing Ec.OS/BS values for both their baseline and year 1 biopsies.||||||0.029||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ec.OS/BS at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.029
72381433|NCT00395538|144271238|OTHER|A contrast statement within the mixed models analysis tested for differences in the Ec.OS/BS between the baseline and the years 2 and 4 (combined) biopsy.|||||<|0.001||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ec.OS/BS at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||<0.001
72395131|NCT02289690|144296701|SUPERIORITY||Hazard Ratio (HR)|1.46||||0.083|TWO_SIDED|80.0|1.104|1.931|||Log Rank|Two-sided log rank test stratified by LDH level.|Hazard ratio estimate was obtained from a Cox proportional hazards model stratified by LDH level. A hazard ratio of \< 1 favors veliparib in combination with carboplatin and etoposide followed by placebo maintenance monotherapy (Arm B).|"If the primary analysis of PFS (Arm A vs Arm C) was statistically significant a fixed sequence testing procedure was to be performed with a 2-sided significance level of 0.2 for the following key secondary endpoints:~1. OS (Arm A vs Arm C)~2. PFS (Arms B vs Arm C)~3. OS (Arm B vs Arm C)~4. ORR (Arm A vs Arm C)~5. ORR (Arm B vs Arm C)~If significance versus Arm C was not demonstrated, all endpoints later in the testing hierarchy were to be considered exploratory."||1.931|1.104|0.083
72556573|NCT04667338|144644365|SUPERIORITY||||||=|0.9177|||||||Chi-squared|||Avoid smoking, especially at night||||=0.9177
72556574|NCT04667338|144644365|SUPERIORITY||||||=|0.4188|||||||Chi-squared|||Exercise daily||||=0.4188
72433916|NCT00635817|144381467|SUPERIORITY_OR_OTHER|||||||0.347||||||There were no adjustments for multiple comparisons.|Wilcoxon (Mann-Whitney)|||Summary statistics were calculated and tests of significance of the ratio versus 1 were performed. All analyses and summaries were conducted separately for the 2 treatment groups (subjects who received leuprolide acetate depot 11.25 mg and 30 mg).||||0.347
72556575|NCT04667338|144644365|SUPERIORITY||||||=|0.5818|||||||Chi-squared|||Avoid large, heavy meals right before bedtime||||=0.5818
72381434|NCT00395538|144271238|OTHER|A contrast statement within the mixed models analysis tested for differences in the Ec.OS/BS between the year 1 biopsy and the years 2 and 4 (combined) biopsy.||||||0.104||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ec.OS/BS at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.104
72381435|NCT00395538|144271239|OTHER|A contrast statement within the mixed models analysis tested for differences in the Ec.ES/BS between the baseline and the year 1 biopsy. P-value interpretation is questionable since there were only 4 participants with non-missing Ec.ES/BS values for both their baseline and year 1 biopsies.||||||0.088||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ec.ES/BS at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.088
72381436|NCT00395538|144271239|OTHER|A contrast statement within the mixed models analysis tested for differences in the Ec.ES/BS between the baseline and the years 2 and 4 (combined) biopsy.||||||0.009||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ec.ES/BS at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.009
72381437|NCT00395538|144271239|OTHER|A contrast statement within the mixed models analysis tested for differences in the Ec.ES/BS between the year 1 biopsy and the years 2 and 4 (combined) biopsy.||||||0.325||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ec.ES/BS at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.325
72381438|NCT00395538|144271240|OTHER|A contrast statement within the mixed models analysis tested for differences in the Ec.AjAR between the baseline and the year 1 biopsy. P-value interpretation is questionable since there were only 3 participants with non-missing Ec.AjAR values for both their baseline and year 1 biopsies.||||||0.001||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ec.AjAR at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.001
72381439|NCT00395538|144271240|OTHER|A contrast statement within the mixed models analysis tested for differences in the Ec.AjAR between the baseline and the years 2 and 4 (combined) biopsy.||||||0.001||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ec.AjAR at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.001
72381440|NCT00395538|144271240|OTHER|A contrast statement within the mixed models analysis tested for differences in the Ec.AjAR between the year 1 biopsy and the years 2 and 4 (combined) biopsy.||||||0.974||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ec.AjAR at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.974
72556576|NCT04667338|144644365|SUPERIORITY||||||=|0.5432|||||||Chi-squared|||Other||||=0.5432
72556577|NCT04667338|144644366|SUPERIORITY||||||=|0.5432|||||||Chi-squared|||Treatment||||=0.5432
72433917|NCT00635817|144381467|SUPERIORITY_OR_OTHER|||||||0.15||95.0||||There were no adjustments for multiple comparisons.|Wilcoxon (Mann-Whitney)|||Summary statistics were calculated and tests of significance of the ratio versus 1 were performed. All analyses and summaries were conducted separately for the 2 treatment groups (subjects who received leuprolide acetate depot 11.25 mg and 30 mg).||||0.150
72433918|NCT01391013|144381478|SUPERIORITY_OR_OTHER|||||||0.08|TWO_SIDED||||||Nonparametric Wilcoxon rank sum test|||||||0.08
72433919|NCT01391013|144381479|SUPERIORITY_OR_OTHER|||||||0.88|TWO_SIDED||||||Nonparametric Wilcoxon rank sum test|||||||0.88
72433920|NCT01391013|144381480|SUPERIORITY_OR_OTHER|||||||0.31|TWO_SIDED||||||Nonparametric Wilcoxon rank sum test|This statistical analysis applies to 'Week 48'.||||||0.31
72433921|NCT01391013|144381481|SUPERIORITY_OR_OTHER|||||||0.37|TWO_SIDED||||||Nonparametric Wilcoxon rank sum test|This statistical analysis applies to 'Week 48'.||||||0.37
72433922|NCT01391013|144381482|SUPERIORITY_OR_OTHER|||||||0.66|TWO_SIDED||||||Nonparametric Wilcoxon rank sum test|This statistical analysis applies to 'Week 48'.||||||0.66
72433923|NCT01391013|144381483|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED||||||Nonparametric Wilcoxon rank sum test|This statistical analysis applies to 'Week 48'.||||||0.02
72433924|NCT01391013|144381484|SUPERIORITY_OR_OTHER|||||||0.12|TWO_SIDED||||||Nonparametric Wilcoxon rank sum test|This statistical analysis applies to 'Week 48'.||||||0.12
72433925|NCT01391013|144381485|SUPERIORITY_OR_OTHER|||||||0.71|TWO_SIDED||||||Nonparametric Wilcoxon rank sum test|This statistical analysis applies to 'Week 48'.||||||0.71
72433926|NCT01391013|144381486|SUPERIORITY_OR_OTHER|||||||0.83|TWO_SIDED||||||Nonparametric Wilcoxon rank sum test|This statistical analysis applies to 'Week 48'.||||||0.83
72433927|NCT01391013|144381487|SUPERIORITY_OR_OTHER|||||||0.66|TWO_SIDED||||||Nonparametric Wilcoxon rank sum test|This statistical analysis applies to 'Week 48'.||||||0.66
72433928|NCT01391013|144381488|SUPERIORITY_OR_OTHER|||||||0.76|TWO_SIDED||||||Nonparametric Wilcoxon rank sum test|||||||0.76
72433929|NCT01391013|144381489|SUPERIORITY_OR_OTHER|||||||0.56|TWO_SIDED||||||Nonparametric Wilcoxon rank sum test|||||||0.56
72433930|NCT01391013|144381490|SUPERIORITY_OR_OTHER|||||||0.11|TWO_SIDED||||||Nonparametric Wilcoxon rank sum test|||||||0.11
72433931|NCT01391013|144381491|SUPERIORITY_OR_OTHER|||||||0.18|TWO_SIDED||||||Nonparametric Wilcoxon rank sum test|||||||0.18
72433932|NCT01391013|144381492|SUPERIORITY_OR_OTHER|||||||0.03|TWO_SIDED||||||Nonparametric Wilcoxon rank sum test|||||||0.03
72433933|NCT01391013|144381493|SUPERIORITY_OR_OTHER|||||||0.04|TWO_SIDED||||||Nonparametric Wilcoxon rank sum test|||||||0.04
72493956|NCT00493038|144516813|NON_INFERIORITY_OR_EQUIVALENCE|"The non-inferiority margin was set to 15% in the protocol. Sample size was estimated using the method as described in Farrington-Manning (STATISTICS IN MEDICINE, Vol. 9; Farrington CP, Manning G: Test statistics and sample size formulae for comparative binomial trials with null hypothesis of non-zero risk difference..., pg.1447-1454 \[1990\]). Estimation was performed to achieve 90% power, based on the equivalence delta of 15%, and a clinical success rate of 80% in the per protocol population."|Mean Difference (Final Values)|2.1||||||95.0|-1.9|6.2|||||Mean difference denotes the difference of clinical cure rates between the two treatment groups (moxifloxacin minus amoxicillin/clavulanate).|Calculated were 95% confidence intervals for the difference in success rates between treatment groups (moxifloxacin minus comparator). Method as described in Koch et al. ('Categorical Data Analysis' in Statistical methodology in the pharmaceutical sciences / edited by D. A. Berry, p. 415 ff., Marcel Dekker, 1990)||6.2|-1.9|
72433934|NCT03820986|144381509|SUPERIORITY|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate and stratified by BRAF mutation positive (Yes vs. No).|Hazard Ratio (HR)|0.83||||0.0295||95.0|0.69|1.0|||Log Rank|One-sided p-value based on log-rank test and stratified by BRAF mutation positive (Yes vs. No).|HR=Pembrolizumab + Lenvatinib vs. Pembrolizumab + Placebo|||1.00|0.69|0.0295
72433935|NCT03820986|144381510|SUPERIORITY|HR based on Cox regression model with Efron's method of tie handling with treatment as a covariate and stratified by BRAF mutation positive (Yes vs. No).|Hazard Ratio (HR)|1.2||||0.9521|TWO_SIDED|95.0|0.97|1.48|||Log Rank|One-sided p-value based on log-rank test and stratified by BRAF mutation positive (Yes vs. No).|HR=Pembrolizumab + Lenvatinib vs. Pembrolizumab + Placebo|||1.48|0.97|0.9521
72433936|NCT03820986|144381515|OTHER||Difference in LS means|-3.69||||0.0345|TWO_SIDED|95.0|-7.1|-0.27|||cLDA model||Difference in LS means=Pembrolizumab + Lenvatinib vs. Pembrolizumab + Placebo|Based on a constrained longitudinal data analysis (cLDA) model with GHS/QoL as the response variable, with covariates for treatment by time interaction, stratification factor BRAF mutation status as covariate.||-0.27|-7.10|0.0345
72433937|NCT03820986|144381516|OTHER||Difference in LS means|-5.49||||0.0004|TWO_SIDED|95.0|-8.53|-2.45|||cLDA model||Difference in LS means=Pembrolizumab + Lenvatinib vs. Pembrolizumab + Placebo|Based on a cLDA model with PF as the response variable, with covariates for treatment by time interaction, stratification factor BRAF mutation status as covariate.||-2.45|-8.53|0.0004
72433938|NCT03820986|144381517|OTHER||Hazard Ratio (HR)|1.58||||0.0001|TWO_SIDED|95.0|1.25|2.0|||Log Rank||HR=Lenvatinib + Pembrolizumab vs. Placebo + Pembrolizumab|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by BRAF mutation status (positive vs wild type or unknown)||2.00|1.25|0.0001
72433939|NCT03820986|144381518|OTHER||Hazard Ratio (HR)|1.95||||0.0001|TWO_SIDED|95.0|1.52|2.5|||Log Rank||HR=Lenvatinib + Pembrolizumab vs. Placebo + Pembrolizumab|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by BRAF mutation status (positive vs wild type or unknown).||2.50|1.52|.0001
72433940|NCT01677936|144381519|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|23.0|||=|0.024||||||Compared to snacks, raisins reduced percent post-prandial glucose levels by 23%, which met the a priori threshold for statistical significance.|t-test, 2 sided|||||||=0.024
72433941|NCT01677936|144381520|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.7|||=|0.035||||||Compared with snacks, the 8.8 mmHg reduction with raisins met the a priori threshold for statistical significance.|t-test, 2 sided|||||||=0.035
72433942|NCT04358549|144381521|SUPERIORITY||Median Difference (Final Values)|14.0||||0.0415|TWO_SIDED|90.0|||||Log Rank|||||||0.0415
72433943|NCT04358549|144381522|SUPERIORITY||Odds Ratio (OR)|0.653|||||TWO_SIDED|90.0|0.19|2.24||||||||2.240|0.190|
72433944|NCT04358549|144381523|SUPERIORITY||Median Difference (Final Values)|3.0||||0.9879|TWO_SIDED|90.0|||||Log Rank|||||||0.9879
72433945|NCT00470626|144381564|SUPERIORITY_OR_OTHER||Probability of Successful Retrieval|0.9||||||95.0|||||||Probability of successful retrieval is from Kaplan-Meier analysis.|||||
72433946|NCT01729819|144381568|SUPERIORITY|The change in mean nocturnal voids from baseline as the dependent variable, baseline mean nocturnal voids as a covariate, and treatments and visit (Month 1, Month 2, and Month 3) as factors, was considered for the analysis. Longitudinal analysis based on repeated measures using analysis of covariance with subject as random effect. Missing values post-baseline were not imputed.|Mean Difference (Final Values)|-0.34||||0.112|TWO_SIDED|95.0|-0.77|0.08|||ANCOVA|Change in mean nocturnal voids as the dependent variable and baseline mean nocturnal voids as a covariate, treatment and visit as factors.|Longitudinal analysis based on repeated measures using analysis of covariance with subject as random effect. The estimated value represents the contrast of combination - tolterodine.|Combination versus tolterodine (i.e. effect in combination group minus effect in tolterodine group) is presented. The trial was to be declared positive if a statistically significant (two-sided, p \< 0.05) positive effect for combining tolterodine and desmopressin compared to tolterodine monotherapy on the primary endpoint had been demonstrated.||0.08|-0.77|0.112
72433947|NCT01729819|144381569|SUPERIORITY||Mean Difference (Final Values)|18.0||||0.385|TWO_SIDED|95.0|-22.96|58.96|||ANCOVA|Change in mean time to first void as dependent variable and baseline mean time to first void as a covariate, and treatment and visit as factors.|The estimated value represents the contrast of combination - tolterodine.|Combination versus tolterodine (i.e. effect in combination group minus effect in tolterodine group) is presented.||58.96|-22.96|0.385
72433948|NCT01729819|144381570|SUPERIORITY||Mean Difference (Final Values)|-64.16||||0.103|TWO_SIDED|95.0|-141.46|13.14|||ANCOVA|Change in mean nocturnal volume as the dependent variable and baseline mean nocturnal volume as a covariate, and treatment and visit as factors.|The estimated value represents the contrast of combination - tolterodine.|Combination versus tolterodine (i.e. effect in combination group minus effect in tolterodine group) is presented||13.14|-141.46|0.103
72433949|NCT01729819|144381571|SUPERIORITY||Odds Ratio (OR)|1.36||||0.352|TWO_SIDED|95.0|0.71|2.62||33% responder status as dependent variable, baseline mean nocturnal voids as covariate, treatment, and visit as factors.|Generalized Estimating Equation|||Combination versus tolterodine (i.e. odds of being responder in combination group versus odds of being responder in tolterodine group) is presented. The proportion of responders during three months of treatment was analysed (i.e. the odds ratio of the odds of being a responder) longitudinally using Generalised Estimating Equation (GEE) for a repeated logistic regression.||2.62|0.71|0.352
72433950|NCT01729819|144381572|SUPERIORITY|Estimated contrast (Combination - tolterodine) from longitudinal analysis including a treatment-by visit interaction term||||||0.443||||||Adjusted treatment difference (Combination-tolterodine) in mean number of nocturnal voids at Month 1|ANCOVA|||Treatment difference (Combination-tolterodine) at Month 1||||0.443
72433951|NCT01729819|144381572|SUPERIORITY|Estimated contrast (Combination - tolterodine) from longitudinal analysis including a treatment-by visit interaction term||||||0.086||||||Adjusted treatment difference in mean number of nocturnal voids (Combination-tolterodine) at Month 2|ANCOVA|||Treatment difference (Combination-tolterodine) at Month 2||||0.086
72433952|NCT01729819|144381572|SUPERIORITY|Estimated contrast (Combination - tolterodine) from longitudinal analysis including a treatment-by visit interaction term||||||0.055||||||Adjusted treatment difference (Combination-tolterodine) in mean number of nocturnal voids at Month 3|ANCOVA|||Treatment difference (Combination-tolterodine) at Month 3||||0.055
72433953|NCT01729819|144381572|SUPERIORITY|Estimated contrast (Combination - tolterodine) from longitudinal analysis including a treatment-by visit interaction term||||||0.106||||||Adjusted treatment difference (Combination-tolterodine) in mean number of nocturnal voids for the duration of 3 months|ANCOVA|||Treatment difference (Combination-tolterodine) for the duration of 3 months||||0.106
72433954|NCT01729819|144381573|SUPERIORITY||Mean Difference (Final Values)|0.42||||0.178|TWO_SIDED|95.0|-0.2|1.05|||ANCOVA|Quality of sleep rating score as dependent variable, baseline quality of sleep rating scale value as a covariate, and responder status as a factor.|Estimated contrast (Combination - tolterodine) from longitudinal analysis of covariance|"Combination versus tolterodine (i.e. score on scale in combination group versus score on scale in tolterodine group) is presented.Statistical analysis for from very tired to wide awake, how do you feel now"||1.05|-0.20|0.178
72433955|NCT01729819|144381573|SUPERIORITY||Mean Difference (Final Values)|0.34||||0.257|TWO_SIDED|95.0|-0.26|0.94|||ANCOVA|Quality of sleep rating score as dependent variable, baseline quality of sleep rating scale value as a covariate, and responder status as a factor.|Estimated contrast (Combination - tolterodine) from longitudinal analysis of covariance|"Combination versus tolterodine (i.e. score on scale in combination group versus score on scale in tolterodine group) is presented. Statistical analysis for Rate how refreshed you feel now"||0.94|-0.26|0.257
72433956|NCT01729819|144381573|SUPERIORITY|Quality of sleep rating score as dependent variable, baseline quality of sleep rating scale value as a covariate, and responder status as a factor.|Mean Difference (Final Values)|0.28||||0.36|TWO_SIDED|95.0|-0.32|0.88|||ANCOVA|Longitudinal analysis of covariance on change from baseline with baseline as a covariate, and treatment and visit as factors.|Estimated contrast (Combination - tolterodine) from longitudinal analysis of covariance|"Combination versus tolterodine (i.e. score on scale in combination group versus score on scale in tolterodine group) is presented. Statistical analysis for Rate the quality of your sleep last night"||0.88|-0.32|0.360
72433957|NCT03686813|144381577|OTHER|||||||0.317|||||||McNemar|||||||0.317
72433958|NCT03686813|144381578|OTHER|||||||0.317|||||||McNemar|||||||0.317
72433959|NCT03686813|144381579|OTHER||||||>|0.999|||||||McNemar|||||||>0.999
72433960|NCT03686813|144381580|OTHER|||||||0.18|||||||McNemar|||||||0.18
72433961|NCT03686813|144381581|OTHER|||||||0.29|||||||McNemar|||||||0.29
72433962|NCT02467491|144381586|SUPERIORITY_OR_OTHER|||||||0.04|TWO_SIDED||||||t-test, 2 sided|||The Short Physical Performance Battery (SPPB) score at baseline was compared with the SPPB scored after 4 weeks of physical activity intervention with a paired t-test||||0.04
72433963|NCT02467491|144381587|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED||||||t-test, 2 sided|||The Short Physical Performance Battery (SPPB) score after 4 weeks of physical activity intervention was compared with the SPPB score after 2 to 3 months from the completion of the physical activity intervention with a paired t-test||||0.02
72433964|NCT03107611|144381588|SUPERIORITY|||||||0.0817|||||||Fisher Exact|||||||0.0817
72433965|NCT03107611|144381588|SUPERIORITY|||||||0.2874|||||||Fisher Exact|||||||0.2874
72381441|NCT00395538|144271241|OTHER|A contrast statement within the mixed models analysis tested for differences in the Ic.O.Th between the baseline and the year 1 biopsy. P-value interpretation is questionable since there were only 4 participants with non-missing Ic.O.Th values for both their baseline and year 1 biopsies.||||||0.004||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ic.O.Th at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.004
72556578|NCT04667338|144644366|SUPERIORITY||||||=|0.0397|||||||Chi-squared|||Routine monitoring visits||||=0.0397
72381442|NCT00395538|144271241|OTHER|A contrast statement within the mixed models analysis tested for differences in the Ic.O.Th between the baseline and the years 2 and 4 (combined) biopsy.||||||0.023||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ic.O.Th at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.023
72381443|NCT00395538|144271241|OTHER|A contrast statement within the mixed models analysis tested for differences in the Ic.O.Th between the year 1 biopsy and the years 2 and 4 (combined) biopsy.||||||0.288||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ic.O.Th at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.288
72381444|NCT00395538|144271242|OTHER|A contrast statement within the mixed models analysis tested for differences in the Ic.MAR between the baseline and the year 1 biopsy. P-value interpretation is questionable since there were only 4 participants with non-missing Ic.MAR values for both their baseline and year 1 biopsies.||||||0.202||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ic.MAR at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.202
72433966|NCT03107611|144381589|EQUIVALENCE|Equivalence margin: -0.20, +0.20|Difference in proportions|-0.03|||||TWO_SIDED|90.0|-0.12|0.06||||||||0.06|-0.12|
72433967|NCT01720446|144381592|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority of semaglutide versus placebo was considered to be confirmed if the upper limit of the two-sided 95% CI for the HR was below 1.8 or equivalent if the p-value for the one-sided test of: H0: HR ≥ 1.8 against Ha: HR \<1.8 was less than 2.5% (or equivalent to 5% for a two-sided test).|Hazard Ratio (HR)|0.74|||<|0.0001|TWO_SIDED|95.0|0.58|0.95||The 'p-value' is for the two-sided Wald test of non-inferiority with limit 1.8.|Regression, Cox||Semaglutide/Placebo|The primary endpoint was analysed using a stratified Cox proportional hazards model with treatment group (semaglutide, placebo) as fixed factor. Assuming the same population MACE risk for the semaglutide and placebo groups (i.e., the population hazards ratio \[HR\] equals 1), a total minimum of 122 events were needed in order to have at least 90% power to ascertain that the upper two-sided 95% confidence limit for the HR was less than 1.8.||0.95|0.58|<0.0001
72433968|NCT01720446|144381592|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.74||||0.0167|TWO_SIDED|95.0|0.58|0.95||The 'p-value' is for the two-sided Wald test of no difference.|Regression, Cox||Semaglutide/Placebo|A post hoc analysis of superiority of semaglutide versus placebo was performed based on the pre-specified Cox proportional hazard analysis using the two-sided Wald test of no difference, with treatment (semaglutide, placebo) as fixed factor and stratified by all possible combinations of the three stratification factors used in the randomisation procedure (in total 9 levels).||0.95|0.58|0.0167
72433969|NCT01720446|144381593|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.74||||0.0016|TWO_SIDED|95.0|0.62|0.89|||Regression, Cox||Semaglutide/Placebo|Analysis was done by Cox proportional hazards model with treatment (semaglutide; placebo) as a fixed factor and stratified by all possible combinations of the three stratification factors used in the randomisation procedure (in total 9 levels).||0.89|0.62|0.0016
72433970|NCT01720446|144381594|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.98||||0.9181|TWO_SIDED|95.0|0.65|1.48|||Regression, Cox||Semaglutide/Placebo|Analysis for CV death was done by Cox proportional hazards model with treatment (semaglutide; placebo) as a fixed factor and stratified by all possible combinations of the three stratification factors used in the randomisation procedure (in total 9 levels).||1.48|0.65|0.9181
72556579|NCT04667338|144644366|SUPERIORITY||||||=|0.0306|||||||Chi-squared|||Tests||||=0.0306
72556580|NCT04667338|144644366|SUPERIORITY||||||=|0.7451|||||||Chi-squared|||Emergency visits||||=0.7451
72556581|NCT04667338|144644366|SUPERIORITY||||||=|0.0845|||||||Chi-squared|||Hospitalizations||||=0.0845
72556582|NCT04667338|144644366|SUPERIORITY||||||=|0.3813|||||||Chi-squared|||Complications||||=0.3813
72556583|NCT04667338|144644368|SUPERIORITY||||||=|0.0034|||||||t-test, 2 sided|||Absenteeism||||=0.0034
72556584|NCT04667338|144644368|SUPERIORITY||||||=|0.2178|||||||t-test, 2 sided|||Presenteeism||||=0.2178
72556585|NCT04667338|144644368|SUPERIORITY||||||=|0.1758|||||||t-test, 2 sided|||Work productivity loss||||=0.1758
72433971|NCT01720446|144381594|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.74||||0.1194|TWO_SIDED|95.0|0.51|1.08|||Regression, Cox||Semaglutide/Placebo|Analysis for non-fatal myocardial infarction was done by Cox proportional hazards model with treatment (semaglutide; placebo) as a fixed factor and stratified by all possible combinations of the three stratification factors used in the randomisation procedure (in total 9 levels).||1.08|0.51|0.1194
72433972|NCT01720446|144381594|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.61||||0.0438|TWO_SIDED|95.0|0.38|0.99|||Regression, Cox||Semaglutide/Placebo|Analysis for non-fatal stroke was done by Cox proportional hazards model with treatment (semaglutide; placebo) as a fixed factor and stratified by all possible combinations of the three stratification factors used in the randomisation procedure (in total 9 levels).||0.99|0.38|0.0438
72433973|NCT01720446|144381594|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.65||||0.0027|TWO_SIDED|95.0|0.5|0.86|||Regression, Cox||Semaglutide/Placebo|Analysis for revascularisation was done by Cox proportional hazards model with treatment (semaglutide; placebo) as a fixed factor and stratified by all possible combinations of the three stratification factors used in the randomisation procedure (in total 9 levels).||0.86|0.50|0.0027
72433974|NCT01720446|144381594|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.82||||0.4914|TWO_SIDED|95.0|0.47|1.44|||Regression, Cox||Semaglutide/Placebo|Analysis for 'unstable angina requiring hospitalisation' was done by Cox proportional hazards model with treatment (semaglutide; placebo) as a fixed factor and stratified by all possible combinations of the three stratification factors used in the randomisation procedure (in total 9 levels).||1.44|0.47|0.4914
72433975|NCT01720446|144381594|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.11||||0.5735|TWO_SIDED|95.0|0.77|1.61|||Regression, Cox||Semaglutide/Placcbo|Analysis for hospitalisation for heart failure was done by Cox proportional hazards model with treatment (semaglutide; placebo) as a fixed factor and stratified by all possible combinations of the three stratification factors used in the randomisation procedure (in total 9 levels).||1.61|0.77|0.5735
72433976|NCT01720446|144381595|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.77||||0.0292|TWO_SIDED|95.0|0.61|0.97|||Regression, Cox||Semaglutide/Placebo|Analysis for all-cause death, non-fatal MI or non-fatal stroke was done by Cox proportional hazards model with treatment (semaglutide; placebo) as a fixed factor and stratified by all possible combinations of the three stratification factors used in the randomisation procedure (in total 9 levels).||0.97|0.61|0.0292
72433977|NCT01720446|144381596|SUPERIORITY_OR_OTHER||Treatment difference|-0.66|||<|0.0001|TWO_SIDED|95.0|-0.8|-0.52|||Mixed Models Analysis||Sema 0.5 mg - Placebo 0.5 mg|Analysis was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.||-0.52|-0.80|<0.0001
72433978|NCT01720446|144381596|SUPERIORITY_OR_OTHER||Treatment difference|-1.05|||<|0.0001|TWO_SIDED|95.0|-1.19|-0.91|||Mixed Models Analysis||Sema 1.0 mg - Placebo 1.0 mg|Analysis was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.||-0.91|-1.19|<0.0001
72433979|NCT01720446|144381597|SUPERIORITY_OR_OTHER||Treatment difference|-0.72|||<|0.0001|TWO_SIDED|95.0|-1.06|-0.38|||Mixed Models Analysis||Sema 0.5 mg - Placebo 0.5 mg|Analysis was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.||-0.38|-1.06|<0.0001
72433980|NCT01720446|144381597|SUPERIORITY_OR_OTHER||Treatment difference|-1.22|||<|0.0001|TWO_SIDED|95.0|-1.56|-0.88|||Mixed Models Analysis||Sema 1.0 mg - Placebo 1.0 mg|Analysis was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.||-0.88|-1.56|<0.0001
72433981|NCT01720446|144381598|SUPERIORITY_OR_OTHER||Treatment difference|-2.95|||<|0.0001|TWO_SIDED|95.0|-3.47|-2.44|||Mixed Models Analysis||Sema 0.5 mg - Placebo|Analysis was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.||-2.44|-3.47|<0.0001
72433982|NCT01720446|144381598|SUPERIORITY_OR_OTHER||Treatment difference|-4.27|||<|0.0001|TWO_SIDED|95.0|-4.78|-3.75|||Mixed Models Analysis||Semaglutide 1.0 mg - Placebo|Analysis was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.||-3.75|-4.78|<0.0001
72433983|NCT01720446|144381599|SUPERIORITY_OR_OTHER||Treatment ratio|0.97||||0.0149|TWO_SIDED|95.0|0.95|1.0|||Mixed Models Analysis||Semaglutide 0.5 mg/Placebo 0.5 mg|Analysis for total cholesterol was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit. The response and its baseline value were log-transformed before analysis.||1.00|0.95|0.0149
72433984|NCT01720446|144381599|SUPERIORITY_OR_OTHER||Treatment ratio|0.99||||0.258|TWO_SIDED|95.0|0.97|1.01|||Mixed Models Analysis||Semaglutide 1.0 mg/Placebo 1.0 mg|Analysis for total cholesterol was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit. The response and its baseline value were log-transformed before analysis.||1.01|0.97|0.2580
72433985|NCT01720446|144381599|SUPERIORITY_OR_OTHER||Treatment ratio|1.0||||0.8106|TWO_SIDED|95.0|0.99|1.02|||Mixed Models Analysis||Semaglutide 0.5 mg/Placebo 0.5 mg|Analysis for HDL-cholesterol was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.||1.02|0.99|0.8106
72433986|NCT01720446|144381599|SUPERIORITY_OR_OTHER||Treatment ratio|1.04|||<|0.0001|TWO_SIDED|95.0|1.02|1.06|||Mixed Models Analysis||Semaglutide 1.0 mg/Placebo 1.0 mg|Analysis for HDL-cholesterol was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.||1.06|1.02|<0.0001
72556586|NCT04667338|144644368|SUPERIORITY||||||=|0.1789|||||||t-test, 2 sided|||Activity Impairment / disability||||=0.1789
72556587|NCT04667338|144644369|SUPERIORITY||||||=|0.5806|||||||Chi-squared|||||||=0.5806
72556588|NCT04667338|144644371|SUPERIORITY||||||=|0.1602|||||||Chi-squared|||Mobility||||=0.1602
72556589|NCT04667338|144644371|SUPERIORITY||||||=|0.5249|||||||Chi-squared|||Self-Care||||=0.5249
72556590|NCT04667338|144644371|SUPERIORITY||||||=|0.1095|||||||Chi-squared|||Usual activities||||=0.1095
72556591|NCT04667338|144644371|SUPERIORITY||||||=|0.3528|||||||Chi-squared|||Pain / Discomfort||||=0.3528
72556592|NCT04667338|144644371|SUPERIORITY||||||=|0.7434|||||||Chi-squared|||Anxiety / Depression||||=0.7434
72381445|NCT00395538|144271242|OTHER|A contrast statement within the mixed models analysis tested for differences in the Ic.MAR between the baseline and the years 2 and 4 (combined) biopsy.||||||0.486||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ic.MAR at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.486
72381446|NCT00395538|144271242|OTHER|A contrast statement within the mixed models analysis tested for differences in the Ic.MAR between the year 1 biopsy and the years 2 and 4 (combined) biopsy.||||||0.535||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ic.MAR at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.535
72381447|NCT00395538|144271243|OTHER|A contrast statement within the mixed models analysis tested for differences in the Ic.OS/BS between the baseline and the year 1 biopsy. P-value interpretation is questionable since there were only 4 participants with non-missing Ic.OS/BS values for both their baseline and year 1 biopsies.||||||0.001||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ic.OS/BS at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.001
72381448|NCT00395538|144271243|OTHER|A contrast statement within the mixed models analysis tested for differences in the Ic.OS/BS between the baseline and the years 2 and 4 (combined) biopsy.||||||0.003||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ic.OS/BS at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.003
72381449|NCT00395538|144271243|OTHER|A contrast statement within the mixed models analysis tested for differences in the Ic.OS/BS between the year 1 biopsy and the years 2 and 4 (combined) biopsy.||||||0.328||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ic.OS/BS at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.328
72381450|NCT00395538|144271244|OTHER|A contrast statement within the mixed models analysis tested for differences in the Ic.ES/BS between the baseline and the year 1 biopsy. P-value interpretation is questionable since there were only 4 participants with non-missing Ic.ES/BS values for both their baseline and year 1 biopsies.||||||0.002||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ic.ES/BS at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.002
72395132|NCT02289690|144296702|SUPERIORITY||Odds Ratio (OR)|1.9||||0.115|TWO_SIDED|80.0|1.1|3.2|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by LDH level.|Odds ratio was from a Cochran-Mantel-Haenszel test stratified by LDH level. An odds ratio of \> 1 favors veliparib in combination with carboplatin and etoposide followed by veliparib maintenance monotherapy (Arm A).|"If the primary analysis of PFS (Arm A vs Arm C) was statistically significant a fixed sequence testing procedure was to be performed with a 2-sided significance level of 0.2 for the following key secondary endpoints:~1. OS (Arm A vs Arm C)~2. PFS (Arms B vs Arm C)~3. OS (Arm B vs Arm C)~4. ORR (Arm A vs Arm C)~5. ORR (Arm B vs Arm C)~If significance versus Arm C was not demonstrated, all endpoints later in the testing hierarchy were to be considered exploratory."||3.2|1.1|0.115
72433987|NCT01720446|144381599|SUPERIORITY_OR_OTHER||Treatment ratio|0.96||||0.0185|TWO_SIDED|95.0|0.93|0.99|||Mixed Models Analysis||Semaglutide 0.5 mg/Placebo 0.5 mg|Analysis for LDL-cholesterol was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.||0.99|0.93|0.0185
72433988|NCT01720446|144381599|SUPERIORITY_OR_OTHER||Treatment ratio|0.99||||0.5996|TWO_SIDED|95.0|0.96|1.03|||Mixed Models Analysis||Semaglutide 1.0 mg/Placebo 1.0 mg|Analysis for LDL-cholesterol was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.||1.03|0.96|0.5996
72618628|NCT01026038|144768106|SUPERIORITY_OR_OTHER||GMC ratio|1.15|||||TWO_SIDED|95.0|0.87|1.52||||||Serotype 5: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||1.52|0.87|
72433989|NCT01720446|144381599|SUPERIORITY_OR_OTHER||Treatment ratio|0.97||||0.1833|TWO_SIDED|95.0|0.93|1.01|||Mixed Models Analysis||Semaglutide 0.5 mg/Placebo 0.5 mg|Analysis for triglycerides was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.||1.01|0.93|0.1833
72433990|NCT01720446|144381599|SUPERIORITY_OR_OTHER||Treatment ratio|0.93||||0.0009|TWO_SIDED|95.0|0.89|0.97|||Mixed Models Analysis||Semaglutide 1.0 mg/Placebo 1.0 mg|Analysis for triglycerides was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.||0.97|0.89|0.0009
72433991|NCT01720446|144381600|SUPERIORITY_OR_OTHER||Treatment ratio|0.78||||0.0003|TWO_SIDED|95.0|0.68|0.89|||Mixed Models Analysis||Sema 0.5 mg / Placebo 0.5 mg|Analysis for urinary albumin to creatinine ration was donne using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit. The response and its baseline value were log-transformed before analysis.||0.89|0.68|0.0003
72433992|NCT01720446|144381600|SUPERIORITY_OR_OTHER||Treatment ratio|0.71|||<|0.0001|TWO_SIDED|95.0|0.62|0.81|||Mixed Models Analysis||Sema 1.0 mg / Placebo 1.0 mg|Analysis for urinary albumin to creatinine ration was donne using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.||0.81|0.62|<0.0001
72433993|NCT01720446|144381601|SUPERIORITY_OR_OTHER||Treatment difference|0.04||||0.9205|TWO_SIDED|95.0|-0.83|0.92|||Mixed Models Analysis||Semaglutide 0.5 mg - Placebo 0.5 mg|Analysis for diastolic blood pressure was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.||0.92|-0.83|0.9205
72433994|NCT01720446|144381601|SUPERIORITY_OR_OTHER||Treatment difference|0.14||||0.7477|TWO_SIDED|95.0|-0.74|1.03|||Mixed Models Analysis||Semaglutide 1.0 mg - Placebo 1.0 mg|Analysis for diastolic blood pressure was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.||1.03|-0.74|0.7477
72433995|NCT01720446|144381601|SUPERIORITY_OR_OTHER||Treatment difference|-1.27||||0.0976|TWO_SIDED|95.0|-2.77|0.23|||Mixed Models Analysis||Semaglutide 0.5 mg - Placebo 0.5 mg|Analysis for systolic blood pressure was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.||0.23|-2.77|0.0976
72433996|NCT01720446|144381601|SUPERIORITY_OR_OTHER||Treatment difference|-2.59||||0.0008|TWO_SIDED|95.0|-4.09|-1.08|||Mixed Models Analysis||Semaglutide 1.0 mg - Placebo 1.0 mg|Analysis for systolic blood pressure was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.||-1.08|-4.09|0.0008
72433997|NCT01720446|144381605|SUPERIORITY_OR_OTHER||Treatment difference|0.5||||0.3171|TWO_SIDED|95.0|-0.48|1.47|||Mixed Models Analysis||Semaglutide 0.5 mg - Placebo 0.5 mg|Analysis for bodily pain was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.||1.47|-0.48|0.3171
72433998|NCT01720446|144381605|SUPERIORITY_OR_OTHER||Treatment difference|1.47||||0.0031|TWO_SIDED|95.0|0.5|2.45|||Mixed Models Analysis||Semaglutide 1.0 mg - Placebo 1.0 mg|Analysis for bodily pain was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.||2.45|0.50|0.0031
72433999|NCT01720446|144381605|SUPERIORITY_OR_OTHER||Treatment difference|0.87||||0.035|TWO_SIDED|95.0|0.06|1.69|||Mixed Models Analysis||Semaglutide 0.5 mg - Placebo 0.5 mg|Analysis for general health was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.||1.69|0.06|0.0350
72434000|NCT01720446|144381605|SUPERIORITY_OR_OTHER||Treatment difference|1.42||||0.0007|TWO_SIDED|95.0|0.6|2.24|||Mixed Models Analysis||Semaglutide 1.0 mg - Placebo 1.0 mg|Analysis for general health was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.||2.24|0.60|0.0007
72434001|NCT01720446|144381605|SUPERIORITY_OR_OTHER||Treatment difference|0.17||||0.7277|TWO_SIDED|95.0|-0.79|1.13|||Mixed Models Analysis||Semaglutide 0.5 mg - Placebo 0.5 mg|Analysis for mental component summary was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.||1.13|-0.79|0.7277
72434002|NCT01720446|144381605|SUPERIORITY_OR_OTHER||Treatment difference|0.97||||0.0489|TWO_SIDED|95.0|0.0|1.94|||Mixed Models Analysis||Semaglutide 1.0 mg - Placebo 1.0 mg|Analysis for mental component summary was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.||1.94|0.00|0.0489
72434003|NCT01720446|144381605|SUPERIORITY_OR_OTHER||Treatment Difference|0.61||||0.186|TWO_SIDED|95.0|-0.3|1.53|||Mixed Models Analysis||Semaglutide 0.5 mg - Placebo 0.5 mg|Analysis for mental health was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.||1.53|-0.30|0.1860
72434004|NCT01720446|144381605|SUPERIORITY_OR_OTHER||Treatment difference|1.39||||0.0029|TWO_SIDED|95.0|0.48|2.31|||Mixed Models Analysis||Semaglutide 1.0 mg - Placebo 1.0 mg|Analysis for mental health was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.||2.31|0.48|0.0029
72381451|NCT00395538|144271244|OTHER|A contrast statement within the mixed models analysis tested for differences in the Ic.ES/BS between the baseline and the years 2 and 4 (combined) biopsy.|||||<|0.001||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ic.ES/BS at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||<0.001
72381452|NCT00395538|144271244|EQUIVALENCE|A contrast statement within the mixed models analysis tested for differences in the Ic.ES/BS between the year 1 biopsy and the years 2 and 4 (combined) biopsy.||||||0.789||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ic.ES/BS at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.789
72381453|NCT00395538|144271245|OTHER|A contrast statement within the mixed models analysis tested for differences in the Ic.AjAR between the baseline and the year 1 biopsy. P-value interpretation is questionable since there were only 4 participants with non-missing Ic.AjAR values for both their baseline and year 1 biopsies.||||||0.651||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ic.AjAR at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.651
72381454|NCT00395538|144271245|OTHER|A contrast statement within the mixed models analysis tested for differences in the Ic.AjAR between the baseline and the years 2 and 4 (combined) biopsy.||||||0.58||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ic.AjAR at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.580
72381455|NCT00395538|144271245|OTHER|A contrast statement within the mixed models analysis tested for differences in the Ic.AjAR between the year 1 biopsy and the years 2 and 4 (combined) biopsy.||||||0.338||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ic.AjAR at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.338
72381456|NCT00395538|144271246|OTHER|A contrast statement within the mixed models analysis tested for differences in the Cortex 1 Spectral Calcium Mean between the baseline and the year 1 biopsy.||||||0.02||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis was performed with Cortex 1 Spectral Calcium Mean as the dependent variable; biopsy year (baseline, year 1, and years 2 and 4 combined) as the independent variable; study cohort as a covariate; and a random effect for participant. No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.020
72381457|NCT00395538|144271246|OTHER|A contrast statement within the mixed models analysis tested for differences in the Cortex 1 Spectral Calcium Mean between the baseline and the years 2 and 4 (combined) biopsy.||||||0.11||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis was performed with Cortex 1 Spectral Calcium Mean as the dependent variable; biopsy year (baseline, year 1, and years 2 and 4 combined) as the independent variable; study cohort as a covariate; and a random effect for participant. No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.110
72381458|NCT00395538|144271246|OTHER|A contrast statement within the mixed models analysis tested for differences in the Cortex 1 Spectral Calcium Mean between the year 1 biopsy and the years 2 and 4 (combined) biopsy.||||||0.764||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis was performed with Cortex 1 Spectral Calcium Mean as the dependent variable; biopsy year (baseline, year 1, and years 2 and 4 combined) as the independent variable; study cohort as a covariate; and a random effect for participant. No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.764
72381459|NCT00395538|144271247|OTHER|A contrast statement within the mixed models analysis tested for differences in the Cortex 1 Spectral Calcium Peak between the baseline and the year 1 biopsy.||||||0.227||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis was performed with Cortex 1 Spectral Calcium Peak as the dependent variable; biopsy year (baseline, year 1, and years 2 and 4 combined) as the independent variable; study cohort as a covariate; and a random effect for participant. No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.227
72434005|NCT01720446|144381605|SUPERIORITY_OR_OTHER||Treatment difference|0.68||||0.0833|TWO_SIDED|95.0|-0.09|1.45|||Mixed Models Analysis||Semaglutide 0.5 mg - Placebo 0.5 mg|Analysis for physical component summary was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.||1.45|-0.09|0.0833
72556593|NCT04667338|144644372|SUPERIORITY||||||=|0.0396|||||||t-test, 2 sided|||||||=0.0396
72618629|NCT01026038|144768106|SUPERIORITY_OR_OTHER||GMC ratio|0.91|||||TWO_SIDED|95.0|0.69|1.2||||||Serotype 5: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.20|0.69|
72381460|NCT00395538|144271247|OTHER|A contrast statement within the mixed models analysis tested for differences in the Cortex 1 Spectral Calcium Peak between the baseline and the years 2 and 4 (combined) biopsy.||||||0.194||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis was performed with Cortex 1 Spectral Calcium Peak as the dependent variable; biopsy year (baseline, year 1, and years 2 and 4 combined) as the independent variable; study cohort as a covariate; and a random effect for participant. No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.194
72381461|NCT00395538|144271247|OTHER|A contrast statement within the mixed models analysis tested for differences in the Cortex 1 Spectral Calcium Peak between the year 1 biopsy and the years 2 and 4 (combined) biopsy.||||||0.434||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis was performed with Cortex 1 Spectral Calcium Peak as the dependent variable; biopsy year (baseline, year 1, and years 2 and 4 combined) as the independent variable; study cohort as a covariate; and a random effect for participant. No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.434
72381462|NCT00395538|144271248|OTHER|A contrast statement within the mixed models analysis tested for differences in the Cortex 1 Spectral Calcium Width between the baseline and the year 1 biopsy.||||||0.003||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis was performed with Cortex 1 Spectral Calcium Width as the dependent variable; biopsy year (baseline, year 1, and years 2 and 4 combined) as the independent variable; study cohort as a covariate; and a random effect for participant. No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.003
72381463|NCT00395538|144271248|OTHER|A contrast statement within the mixed models analysis tested for differences in the Cortex 1 Spectral Calcium Width between the baseline and the years 2 and 4 (combined) biopsy.||||||0.002||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis was performed with Cortex 1 Spectral Calcium Width as the dependent variable; biopsy year (baseline, year 1, and years 2 and 4 combined) as the independent variable; study cohort as a covariate; and a random effect for participant. No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.002
72381464|NCT00395538|144271248|OTHER|A contrast statement within the mixed models analysis tested for differences in the Cortex 1 Spectral Calcium Width between the year 1 biopsy and the years 2 and 4 (combined) biopsy.||||||0.787||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis was performed with Cortex 1 Spectral Calcium Width as the dependent variable; biopsy year (baseline, year 1, and years 2 and 4 combined) as the independent variable; study cohort as a covariate; and a random effect for participant. No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.787
72381465|NCT00395538|144271249|OTHER|A contrast statement within the mixed models analysis tested for differences in the Cortex 1 Spectral Calcium Low between the baseline and the year 1 biopsy.||||||0.082||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis was performed with Cortex 1 Spectral Calcium Low as the dependent variable; biopsy year (baseline, year 1, and years 2 and 4 combined) as the independent variable; study cohort as a covariate; and a random effect for participant. No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.082
72381466|NCT00395538|144271249|OTHER|A contrast statement within the mixed models analysis tested for differences in the Cortex 1 Spectral Calcium Low between the baseline and the years 2 and 4 (combined) biopsy.||||||0.057||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis was performed with Cortex 1 Spectral Calcium Low as the dependent variable; biopsy year (baseline, year 1, and years 2 and 4 combined) as the independent variable; study cohort as a covariate; and a random effect for participant. No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.057
72381467|NCT00395538|144271249|OTHER|A contrast statement within the mixed models analysis tested for differences in the Cortex 1 Spectral Calcium Low between the year 1 biopsy and the years 2 and 4 (combined) biopsy.||||||0.547||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis was performed with Cortex 1 Spectral Calcium Low as the dependent variable; biopsy year (baseline, year 1, and years 2 and 4 combined) as the independent variable; study cohort as a covariate; and a random effect for participant. No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.547
72434006|NCT01720446|144381605|SUPERIORITY_OR_OTHER||Treatment difference|1.4||||0.0004|TWO_SIDED|95.0|0.62|2.17|||Mixed Models Analysis||Semaglutide 1.0 mg - Placebo 1.0 mg|Analysis for physical component summary was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.||2.17|0.62|0.0004
72434007|NCT01720446|144381605|SUPERIORITY_OR_OTHER||Treatment difference|0.8||||0.0799|TWO_SIDED|95.0|-0.1|1.69|||Mixed Models Analysis||Semaglutide 0.5 mg - Placebo 0.5 mg|Analysis for physical functioning was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.||1.69|-0.10|0.0799
72556594|NCT04667338|144644373|SUPERIORITY||||||=|0.0394|||||||t-test, 2 sided|||Effectiveness||||=0.0394
72556595|NCT04667338|144644373|SUPERIORITY||||||=|0.3093|||||||t-test, 2 sided|||Convenience||||=0.3093
72556596|NCT04667338|144644373|SUPERIORITY||||||=|0.2296|||||||t-test, 2 sided|||Global satisfaction||||=0.2296
72556597|NCT04667338|144644374|SUPERIORITY||||||=|0.1817|||||||Chi-squared|||Depression||||=0.1817
72556598|NCT04667338|144644374|SUPERIORITY||||||=|0.0885|||||||Chi-squared|||Bipolar disorder||||=0.0885
72556599|NCT04667338|144644374|SUPERIORITY||||||=|0.3043|||||||Chi-squared|||Anxiety disorders||||=0.3043
72381468|NCT00395538|144271250|OTHER|A contrast statement within the mixed models analysis tested for differences in the Cortex 1 Spectral Calcium High between the baseline and the year 1 biopsy.||||||0.922||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis was performed with Cortex 1 Spectral Calcium High as the dependent variable; biopsy year (baseline, year 1, and years 2 and 4 combined) as the independent variable; study cohort as a covariate; and a random effect for participant. No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.922
72381469|NCT00395538|144271250|OTHER|A contrast statement within the mixed models analysis tested for differences in the Cortex 1 Spectral Calcium High between the year 1 and the years 2 and 4 (combined) biopsy.||||||0.342||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis was performed with Cortex 1 Spectral Calcium High as the dependent variable; biopsy year (baseline, year 1, and years 2 and 4 combined) as the independent variable; study cohort as a covariate; and a random effect for participant. No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.342
72381470|NCT00395538|144271250|OTHER|A contrast statement within the mixed models analysis tested for differences in the Cortex 1 Spectral Calcium High between the year 1 biopsy and the years 2 and 4 (combined) biopsy.||||||0.449||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis was performed with Cortex 1 Spectral Calcium High as the dependent variable; biopsy year (baseline, year 1, and years 2 and 4 combined) as the independent variable; study cohort as a covariate; and a random effect for participant. No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.449
72381471|NCT01074047|144271283|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.84||||0.0829|TWO_SIDED|95.0|0.69|1.02|||Log Rank|The p-value is two-sided from an unstratified log-rank test|The hazard ratio is from a Cox proportional hazards model stratified by ECOG performance status and cytogenetic risk status.|||1.02|0.69|0.0829
72381472|NCT01074047|144271283|SUPERIORITY||Hazard Ratio (HR)|0.85||||0.1009|TWO_SIDED|95.0|0.69|1.03|||Log Rank||The hazard ratio is from a Cox proportional hazards model stratified by ECOG performance status and cytogenetic risk status.|||1.03|0.69|0.1009
72381473|NCT01074047|144271284|SUPERIORITY_OR_OTHER||Difference|12.26|||||TWO_SIDED|95.0|3.5|21.0|||||Estimates of the 1-year (365 day) survival probabilities and corresponding 95% confidence intervals (CI) were presented by treatment group. The CI for the difference in the 1-year survival probabilities was derived using Greenwoods variance estimate.|||21.0|3.5|
72381474|NCT01074047|144271285|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.87||||0.1495|TWO_SIDED|95.0|0.72|1.05|||Log Rank|2 sided unstratified|The hazard ratio is from an unstratified Cox proportional hazards model.|Median is estimated from a Kaplan-Meier distribution of EFS||1.05|0.72|0.1495
72381475|NCT01074047|144271286|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.11||||0.5832|TWO_SIDED|95.0|0.75|1.66|||Log Rank|2 sided unstratified|The hazard ratio is from an unstratified Cox proportional hazards model.|Median is estimated from a Kaplan-Meier distribution of RFS||1.66|0.75|0.5832
72381476|NCT01074047|144271287|SUPERIORITY_OR_OTHER|||||||0.5384|||||||Fisher Exact|P-value is from Fishers exact test||||||0.5384
72381477|NCT01074047|144271289|SUPERIORITY_OR_OTHER|||||||0.0376|||||||Fisher Exact|P-value is from Fishers exact test||||||0.0376
72381478|NCT01074047|144271313|SUPERIORITY_OR_OTHER||Relative Ratio|0.79||||0.0721|TWO_SIDED|95.0|0.62|1.02|||negative binomial regression analysis|||||1.02|0.62|0.0721
72556600|NCT04667338|144644374|SUPERIORITY||||||=|0.0885|||||||Chi-squared|||Panic disorder||||=0.0885
72556601|NCT04667338|144644374|SUPERIORITY||||||=|0.5603|||||||Chi-squared|||Phobia disorder||||=0.5603
72556602|NCT04667338|144644374|SUPERIORITY||||||=|0.5603|||||||Chi-squared|||Obsessive compulsive disorder||||=0.5603
72556603|NCT04667338|144644374|SUPERIORITY||||||=|0.3646|||||||Chi-squared|||Diagnosis of ADHD||||=0.3646
72556604|NCT04667338|144644374|SUPERIORITY||||||=|0.2615|||||||Chi-squared|||Obesity||||=0.2615
72556605|NCT04667338|144644374|SUPERIORITY||||||=|0.3076|||||||Chi-squared|||Endocrine Disorders||||=0.3076
72556606|NCT04667338|144644374|SUPERIORITY||||||=|0.409|||||||Chi-squared|||Peripheral vascular disease||||=0.4090
72556607|NCT04667338|144644374|SUPERIORITY||||||=|0.5603|||||||Chi-squared|||Cardiovascular accident or transient ischemic attack (TIA)||||=0.5603
72556608|NCT04667338|144644374|SUPERIORITY||||||=|0.5603|||||||Chi-squared|||COPD||||=0.5603
72556609|NCT04667338|144644374|SUPERIORITY||||||=|0.5603|||||||Chi-squared|||Connective tissue disease||||=0.5603
72556610|NCT04667338|144644374|SUPERIORITY||||||=|0.7451|||||||Chi-squared|||Liver Disease||||=0.7451
72556611|NCT04667338|144644374|SUPERIORITY||||||=|0.3108|||||||Chi-squared|||Diabetes Mellitus||||=0.3108
72556612|NCT04667338|144644374|SUPERIORITY||||||=|0.2407|||||||Chi-squared|||Solid Tumor||||=0.2407
72556613|NCT04667338|144644374|SUPERIORITY||||||=|0.5603|||||||Chi-squared|||AIDS||||=0.5603
72556614|NCT04667338|144644374|SUPERIORITY||||||=|0.1739|||||||Chi-squared|||Others||||=0.1739
72556615|NCT04667338|144644375|SUPERIORITY||||||=|0.3585|||||||t-test, 2 sided|||||||=0.3585
72556616|NCT03488108|144644385|SUPERIORITY|||||||0.009|||||||Wilcoxon (Mann-Whitney)|||||||.009
72556617|NCT03488108|144644386|SUPERIORITY|||||||0.9|||||||Wilcoxon (Mann-Whitney)|||||||.90
72556618|NCT03488108|144644387|SUPERIORITY|||||||0.003|||||||Wilcoxon (Mann-Whitney)|||||||.003
72556619|NCT03488108|144644388|SUPERIORITY|||||||0.005|||||||Wilcoxon (Mann-Whitney)|||||||.005
72618630|NCT01026038|144768106|SUPERIORITY_OR_OTHER||GMC ratio|0.79|||||TWO_SIDED|95.0|0.57|1.1||||||Serotype 5: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.10|0.57|
72618631|NCT01026038|144768106|SUPERIORITY_OR_OTHER||GMC ratio|2.14|||||TWO_SIDED|95.0|1.52|3.02||||||Serotype 6A: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||3.02|1.52|
72434008|NCT01720446|144381605|SUPERIORITY_OR_OTHER||Treatment difference|1.5||||0.0011|TWO_SIDED|95.0|0.6|2.4|||Mixed Models Analysis||Semaglutide 1.0 mg - Placebo 1.0 mg|Analysis for physical functioning was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.||2.40|0.60|0.0011
72434009|NCT01720446|144381605|SUPERIORITY_OR_OTHER||Treatment difference|0.53||||0.3717|TWO_SIDED|95.0|-0.63|1.68|||Mixed Models Analysis||Semaglutide 0.5 mg - Placebo 0.5 mg|Analysis for role emotional was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.||1.68|-0.63|0.3717
72434010|NCT01720446|144381605|SUPERIORITY_OR_OTHER||Treatment difference|0.94||||0.1136|TWO_SIDED|95.0|-0.22|2.1|||Mixed Models Analysis||Semaglutide 1.0 mg - Placebo 1.0 mg|Analysis for role emotional was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.||2.10|-0.22|0.1136
72434011|NCT01720446|144381605|SUPERIORITY_OR_OTHER||Treatment difference|0.72||||0.1431|TWO_SIDED|95.0|-0.24|1.67|||Mixed Models Analysis||Semaglutide 0.5 mg - Placebo 0.5 mg|Analysis for role physical was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.||1.67|-0.24|0.1431
72434012|NCT01720446|144381605|SUPERIORITY_OR_OTHER||Treatment difference|1.14||||0.0197|TWO_SIDED|95.0|0.18|2.11|||Mixed Models Analysis||Semaglutide 1.0 mg - Placebo 1.0 mg|Analysis for role physical was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.||2.11|0.18|0.0197
72434013|NCT01720446|144381605|SUPERIORITY_OR_OTHER||Treatment difference|-0.05||||0.9223|TWO_SIDED|95.0|-1.03|0.93|||Mixed Models Analysis||Semaglutide 0.5 mg - Placebo 0.5 mg|Analysis for social functioning was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.||0.93|-1.03|0.9223
72434014|NCT01720446|144381605|SUPERIORITY_OR_OTHER||Treatment difference|1.14||||0.0237|TWO_SIDED|95.0|0.15|2.13|||Mixed Models Analysis||Semaglutide 1.0 mg - Placebo 1.0 mg|Analysis for social functioning was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.||2.13|0.15|0.0237
72434015|NCT01720446|144381605|SUPERIORITY_OR_OTHER||Treatment difference|0.33||||0.4523|TWO_SIDED|95.0|-0.53|1.19|||Mixed Models Analysis||Semaglutide 0.5 mg - Placebo 0.5 mg|Analysis for vitality was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.||1.19|-0.53|0.4523
72618632|NCT01026038|144768106|SUPERIORITY_OR_OTHER||GMC ratio|1.64|||||TWO_SIDED|95.0|1.16|2.3||||||Serotype 6A: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||2.30|1.16|
72434016|NCT01720446|144381605|SUPERIORITY_OR_OTHER||Treatment difference|1.2||||0.0064|TWO_SIDED|95.0|0.34|2.07|||Mixed Models Analysis||Semaglutide 1.0 mg - Placebo 1.0 mg|Analysis for vitality was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.||2.07|0.34|0.0064
72434017|NCT01720446|144381606|SUPERIORITY_OR_OTHER||Treatment ratio|0.99||||0.7796|TWO_SIDED|95.0|0.95|1.04|||Mixed Models Analysis||Semaglutide 0.5 mg/Placebo 0.5 mg|Analysis for free fatty acids was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.||1.04|0.95|0.7796
72434018|NCT01720446|144381606|SUPERIORITY_OR_OTHER||Treatment ratio|0.92||||0.0003|TWO_SIDED|95.0|0.88|0.96|||Mixed Models Analysis||Semaglutide 1.0 mg/Placebo 1.0 mg|Analysis for free fatty acids was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.||0.96|0.88|0.0003
72434019|NCT01720446|144381607|SUPERIORITY_OR_OTHER||Treatment difference|2.02|||<|0.0001|TWO_SIDED|95.0|1.07|2.98|||Mixed Models Analysis||Semaglutide 0.5 mg - Placebo 0.5 mg|Analysis for pulse rate was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.||2.98|1.07|<0.0001
72434020|NCT01720446|144381607|SUPERIORITY_OR_OTHER||Treatment difference|2.47|||<|0.0001|TWO_SIDED|95.0|1.52|3.43|||Mixed Models Analysis||Semaglutide 1.0 mg - Placebo 1.0 mg|Analysis for pulse rate was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.||3.43|1.52|<0.0001
72434021|NCT02175212|144381609|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.88||||0.01|TWO_SIDED|95.0|1.12|3.15|||Regression, Cox|||||3.15|1.12|0.01
72434022|NCT02175212|144381610|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|2.31||||0.01|TWO_SIDED|95.0|1.23|3.85|||Regression, Cox|||||3.85|1.23|0.01
72434023|NCT02175212|144381611|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|2.48||||0.009|TWO_SIDED|95.0|1.31|4.68|||Regression, Cox|||||4.68|1.31|0.009
72434024|NCT00606580|144381634|SUPERIORITY_OR_OTHER|||||||0.0001|||||||Chi-squared|||H01: There is no difference in the final clinical cure rate between WR 279,396 and Vehicle AND there is no difference in the final clinical cure rate between Paromomycin Alone and Vehicle.||||0.0001
72434025|NCT00606580|144381634|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Chi-squared|||H01: There is no difference in the final clinical cure rate between WR 279,396 and Vehicle AND there is no difference in the final clinical cure rate between Paromomycin Alone and Vehicle.||||<0.0001
72434026|NCT00606580|144381634|NON_INFERIORITY_OR_EQUIVALENCE|Test of H02: If H01 was rejected, then H02 would be tested. The comparison of WR 279,396 versus Paromomycin Alone would be considered statistically significant if p \< .05.||||||0.871|||||||Chi-squared|||H02: There is no difference in clinical cure between WR 279,396 and Paromomycin Alone. Test of H02: If H01 was rejected, then H02 would be tested. The comparison of WR 279,396 versus Paromomycin Alone would be considered statistically significant if p \< .05.||||0.871
72381479|NCT05063318|144271322|SUPERIORITY||Least-squares geometric mean ratio|272.73|||||TWO_SIDED|90.0|213.22|348.86|||ANOVA|ANOVA mixed-effects model included treatment, period and sequence as fixed effects, and patient (sequence) as a random effect||||348.86|213.22|
72618633|NCT01026038|144768106|SUPERIORITY_OR_OTHER||GMC ratio|0.76|||||TWO_SIDED|95.0|0.51|1.14||||||Serotype 6A: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.14|0.51|
72381480|NCT05063318|144271323|SUPERIORITY||Least-squares geometric mean ratio|236.73|||||TWO_SIDED|90.0|177.35|316.0|||ANOVA|ANOVA mixed-effects model included treatment, period and sequence as fixed effects, and patient (sequence) as a random effect||||316.00|177.35|
72381481|NCT05063318|144271324|SUPERIORITY||least-squares geometric mean ratio.|115.51|||||TWO_SIDED|90.0|100.07|133.33|||ANOVA|ANOVA mixed-effects model included treatment, period and sequence as fixed effects, and patient (sequence) as a random effect||||133.33|100.07|
72381482|NCT05063318|144271325|SUPERIORITY||Least-squares geometric mean ratio.|217.57|||||TWO_SIDED|90.0|151.81|311.82|||ANOVA|ANOVA mixed-effects model included treatment, period and sequence (TR or RT) as fixed effects, and patient (sequence) as a random effect.||||311.82|151.81|
72381483|NCT05063318|144271326|SUPERIORITY||Least-squares geometric mean ratio|36.67|||||TWO_SIDED|90.0|28.66|46.9|||ANOVA|ANOVA mixed-effects model included treatment, period and sequence as fixed effects, and patient (sequence) as a random effect||||46.9|28.66|
72381484|NCT05063318|144271327|SUPERIORITY||Least-squares geometric mean ratio|99.89|||||TWO_SIDED|90.0|65.76|151.74|||ANOVA|ANOVA mixed-effects model included treatment, period and sequence as fixed effects, and patient (sequence) as a random effect||||151.74|65.76|
72381485|NCT01659658|144271328|SUPERIORITY||Odds Ratio (OR)|1.1|||=|0.7623|TWO_SIDED|95.0|0.6|2.01||P-value was calculated from the unstratified Cochran-Mantel-Haenszel (CMH) test to compare hematologic response rate between the treatment arms.|Cochran-Mantel-Haenszel||Odds ratio was derived from a logistic regression model with treatment and 95% confidence interval (CI) for the odds ratio was based on the Wald approximation.|Statistical analysis was planned to be collected and analyzed in a combined manner for the non-ixazomib arm groups versus ixazomib group in this outcome measure.||2.01|0.60|=0.7623
72381486|NCT01659658|144271329|SUPERIORITY||Odds Ratio (OR)|0.75|||=|0.351|TWO_SIDED|95.0|0.41|1.38||P-value was calculated from the unstratified CMH test to make comparisons between the 2 treatment arms.|Cochran-Mantel-Haenszel||Odds ratio was derived from a logistic regression model with treatment and 95% CI for the odds ratio was based on the Wald approximation.|||1.38|0.41|=0.3510
72381487|NCT01659658|144271331|SUPERIORITY||Hazard Ratio (HR)|0.82|||=|0.389|TWO_SIDED|95.0|0.52|1.29||P-value was calculated using log-rank test stratified by the stratification factors.|Log Rank||||Unadjusted stratified Cox regression model was used to estimate the hazard ratio and its 95% CIs for the treatment effect using the stratification factors.|1.29|0.52|=0.389
72381488|NCT01659658|144271332|SUPERIORITY||Hazard Ratio (HR)|0.76|||=|0.135|TWO_SIDED|95.0|0.52|1.09||P-value was calculated using stratified log-rank test with stratification factors.|Log Rank||||Unadjusted stratified Cox regression model was used to estimate the hazard ratio and its 95% CIs for the treatment effect using the stratification factors.|1.09|0.52|=0.135
72381489|NCT01659658|144271333|SUPERIORITY||Hazard Ratio (HR)|0.76||||0.2421|TWO_SIDED|95.0|0.48|1.21||P-value was calculated using log-rank test stratified by the stratification factors.|Log Rank||||Unadjusted stratified Cox regression model was used to estimate the hazard ratio and its 95% CIs for the treatment effect using the stratification factors.|1.21|0.48|0.2421
72381490|NCT01659658|144271334|SUPERIORITY||Hazard Ratio (HR)|0.62|||=|0.036|TWO_SIDED|95.0|0.39|0.97||P-value was calculated using log-rank test stratified by the stratification factors.|Log Rank||||Unadjusted stratified Cox regression model was used to estimate the hazard ratio and its 95% CIs for the treatment effect using the stratification factors.|0.97|0.39|=0.036
72381491|NCT01659658|144271335|SUPERIORITY||Odds Ratio (OR)|1.69|||=|0.226|TWO_SIDED|95.0|0.72|3.99||P-value was calculated from the unstratified CMH test to compare vital organ response rate between the 2 treatment arms.|Cochran-Mantel-Haenszel||Odds ratio was calculated from a logistic regression model with treatment and 95% CI for the odds ratio was based on the Wald approximation.|||3.99|0.72|=0.2260
72381492|NCT01659658|144271336|SUPERIORITY||Hazard Ratio (HR)|0.76|||=|0.163|TWO_SIDED|95.0|0.52|1.12||P-value was calculated using stratified log-rank test with stratification factors.|Log Rank||Unadjusted stratified Cox regression model was used to estimate the hazard ratio and its 95% CIs for the treatment effect using the stratification factors.|||1.12|0.52|=0.163
72381493|NCT01659658|144271339|SUPERIORITY||Hazard Ratio (HR)|0.68|||=|0.025|TWO_SIDED|95.0|0.49|0.96||P-value was calculated using stratified log-rank test with stratification factors.|Log Rank||||Unadjusted stratified Cox regression model was used to estimate the hazard ratio and its 95% CIs for the treatment effect using the stratification factors.|0.96|0.49|=0.025
72381494|NCT01659658|144271340|SUPERIORITY||Hazard Ratio (HR)|0.58|||=|0.01|TWO_SIDED|95.0|0.38|0.88||P-value was calculated using stratified log-rank test with stratification factors.|Log Rank||||Unadjusted stratified Cox regression model was used to estimate the hazard ratio and its 95% CIs for the treatment effect using the stratification factors.|0.88|0.38|=0.010
72381495|NCT04233034|144271354|SUPERIORITY||Mean Difference (Final Values)|-0.01||||0.89|TWO_SIDED|95.0|-0.11|0.1|||Mixed Models Analysis|The model included age, days from T1D diagnosis to randomization, and drug group as fixed effects and clinical site as a random effect.|Mean difference (HCL - Non-HCL) at 52 weeks adjusted for age, days from T1D diagnosis to randomization, RCT drug group, and clinical site.|||0.10|-0.11|0.89
72434027|NCT00606580|144381635|SUPERIORITY_OR_OTHER|||||||0.0006|||||||Chi-squared|||||||0.0006
72434028|NCT00606580|144381635|SUPERIORITY_OR_OTHER|||||||0.0002|||||||Chi-squared|||||||0.0002
72434029|NCT00606580|144381635|NON_INFERIORITY_OR_EQUIVALENCE|Test of H02: If H01 was rejected, then H02 would be tested. The comparison of WR 279,396 versus Paromomycin Alone would be considered statistically significant if p \< .05.||||||0.767|||||||Chi-squared|||||||0.767
72434030|NCT00606580|144381636|SUPERIORITY_OR_OTHER|||||||0.33|||||||Log Rank|Mantel-Cox (log-rank) grouped failure time test using proportion re-epithelialized at each of the scheduled assessments through Day 42 without relapse||||||0.330
72434031|NCT00606580|144381636|SUPERIORITY_OR_OTHER|||||||0.275|||||||Log Rank|||||||0.275
72381496|NCT04233034|144271354|SUPERIORITY||Mean Difference (Final Values)|0.14||||0.04|TWO_SIDED|95.0|0.01|0.27|||Mixed Models Analysis|The model included age, days from T1D diagnosis to randomization, and Intensive group as fixed effects and clinical site as a random effect.|Mean difference (Verapamil - Placebo) at 52 weeks adjusted for age, days from T1D diagnosis to randomization, RCT intensive/standard care group, and clinical site.|||0.27|0.01|0.04
72381497|NCT04233034|144271355|SUPERIORITY||Mean Difference (Final Values)|-0.01||||0.8|TWO_SIDED|95.0|-0.1|0.08||P-value adjusted for multiplicity using the Benjamini-Hochberg procedure.|Mixed Models Analysis|The model included age, days from T1D diagnosis to randomization, and drug group as fixed effects and clinical site as a random effect.|Mean difference (HCL - Non-HCL) at 13 weeks adjusted for age, days from T1D diagnosis to randomization, RCT drug group, and clinical site.|||0.08|-0.10|0.80
72381498|NCT04233034|144271355|SUPERIORITY||Mean Difference (Final Values)|0.03||||0.8|TWO_SIDED|95.0|-0.08|0.13||P-value adjusted for multiplicity using the Benjamini-Hochberg procedure.|Mixed Models Analysis|The model included age, days from T1D diagnosis to randomization, and drug group as fixed effects and clinical site as a random effect.|Mean difference (HCL - Non-HCL) at 26 weeks adjusted for age, days from T1D diagnosis to randomization, RCT drug group, and clinical site.|||0.13|-0.08|0.80
72381499|NCT04233034|144271355|SUPERIORITY||Mean Difference (Final Values)|-0.02||||0.8|TWO_SIDED|95.0|-0.13|0.09||P-value was adjusted for multiplicity using the Benjamini-Hochberg procedure.|Mixed Models Analysis|The model included age, days from T1D diagnosis to randomization, and drug group as fixed effects and clinical site as a random effect.|Mean difference (HCL - Non-HCL) at 39 weeks adjusted for age, days from T1D diagnosis to randomization, RCT drug group, and clinical site.|||0.09|-0.13|0.80
72381500|NCT04233034|144271355|SUPERIORITY||Mean Difference (Final Values)|0.02||||0.69|TWO_SIDED|95.0|-0.09|0.13||P-value adjusted for multiplicity using the Benjamini-Hochberg procedure.|Mixed Models Analysis|The model included age, days from T1D diagnosis to randomization, and Intensive group as fixed effects and clinical site as a random effect.|Mean difference (Verapamil - Placebo) at 13 weeks adjusted for age, days from T1D diagnosis to randomization, RCT intensive/standard care group, and clinical site.|||0.13|-0.09|0.69
72381501|NCT04233034|144271355|SUPERIORITY||Mean Difference (Final Values)|0.12||||0.08|TWO_SIDED|95.0|-0.02|0.25||P-value was adjusted for multiplicity using the Benjamini-Hochberg procedure.|Mixed Models Analysis|The model included age, days from T1D diagnosis to randomization, and Intensive group as fixed effects and clinical site as a random effect.|Mean difference (Verapamil - Placebo) at 26 weeks adjusted for age, days from T1D diagnosis to randomization, RCT intensive/standard care group, and clinical site.|||0.25|-0.02|0.08
72381502|NCT04233034|144271355|SUPERIORITY||Mean Difference (Final Values)|0.14||||0.08|TWO_SIDED|95.0|-0.01|0.28||P-value adjusted for multiplicity using the Benjamini-Hochberg procedure.|Mixed Models Analysis|The model included age, days from T1D diagnosis to randomization, and Intensive group as fixed effects and clinical site as a random effect.|Mean difference (Verapamil - Placebo) at 39 weeks adjusted for age, days from T1D diagnosis to randomization, RCT intensive/standard care group, and clinical site.|||0.28|-0.01|0.08
72381503|NCT04233034|144271358|SUPERIORITY||Mean Difference (Final Values)|-25.0|||<|0.001|TWO_SIDED|95.0|-37.0|-14.0|||Mixed Models Analysis||Mean difference (HCL - Non-HCL) at 52 weeks adjusted for age, days from T1D diagnosis to randomization, RCT drug group, and clinical site.|||-14|-37|<0.001
72381504|NCT04233034|144271358|SUPERIORITY||Mean Difference (Final Values)|-4.0||||0.74|TWO_SIDED|95.0|-25.0|16.0|||Mixed Models Analysis||Mean difference (Verapamil - Placebo) at 52 weeks adjusted for age, days from T1D diagnosis to randomization, RCT intensive/standard care group, and clinical site.|||16|-25|0.74
72381505|NCT04233034|144271359|SUPERIORITY||Mean Difference (Final Values)|16.0|||<|0.001|TWO_SIDED|95.0|10.0|22.0|||Mixed Models Analysis||Mean difference (HCL - Non-HCL) at 52 weeks adjusted for age, days from T1D diagnosis to randomization, RCT drug group, and clinical site.|||22|10|<0.001
72381506|NCT04233034|144271359|SUPERIORITY||Mean Difference (Final Values)|2.0||||0.74|TWO_SIDED|95.0|-9.0|13.0|||Mixed Models Analysis||Mean difference (Verapamil - Placebo) at 52 weeks adjusted for age, days from T1D diagnosis to randomization, RCT intensive/standard care group, and clinical site.|||13|-9|0.74
72381507|NCT04233034|144271360|SUPERIORITY||Mean Difference (Final Values)|16.0|||<|0.001|TWO_SIDED|95.0|10.0|22.0|||Mixed Models Analysis||Mean difference (HCL - Non-HCL) at 52 weeks adjusted for age, days from T1D diagnosis to randomization, RCT drug group, and clinical site.|||22|10|<0.001
72381508|NCT04233034|144271360|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.95|TWO_SIDED|95.0|-8.0|14.0|||Mixed Models Analysis||Mean difference (Verapamil - Placebo) at 52 weeks adjusted for age, days from T1D diagnosis to randomization, RCT intensive/standard care group, and clinical site.|||14|-8|0.95
72381509|NCT04233034|144271361|SUPERIORITY||Risk Difference (RD)|0.38|||<|0.001|TWO_SIDED|95.0|0.21|0.53|||Regression, Logistic|||||0.53|0.21|<0.001
72381510|NCT04233034|144271361|SUPERIORITY||Risk Difference (RD)|0.03||||0.79|TWO_SIDED|95.0|-0.26|0.32|||Regression, Logistic|||||0.32|-0.26|0.79
72381511|NCT04233034|144271363|SUPERIORITY||Mean Difference (Final Values)|-16.0|||<|0.001|TWO_SIDED|95.0|-22.0|-9.0|||Mixed Models Analysis||Mean difference (HCL - Non-HCL) at 52 weeks adjusted for age, days from T1D diagnosis to randomization, RCT drug group, and clinical site.|||-9|-22|<0.001
72381512|NCT04233034|144271363|SUPERIORITY||Mean Difference (Final Values)|-2.0||||0.74|TWO_SIDED|95.0|-13.0|9.0|||Mixed Models Analysis||Mean difference at 52 weeks (verapamil - placebo) adjusted for age, days from T1D diagnosis to randomization, RCT intensive/standard care group, and clinical site.|||9|-13|0.74
72381513|NCT04233034|144271364|SUPERIORITY||Mean Difference (Final Values)|-4.0||||0.003|TWO_SIDED|95.0|-7.0|-1.0|||Mixed Models Analysis||Mean difference (HCL - Non-HCL) at 52 weeks adjusted for age, days from T1D diagnosis to randomization, RCT drug group, and clinical site.|||-1|-7|0.003
72381514|NCT04233034|144271364|SUPERIORITY||Mean Difference (Final Values)|-1.0||||0.74|TWO_SIDED|95.0|-6.0|4.0|||Mixed Models Analysis||Mean difference (verapamil - placebo) at 52 weeks adjusted for age, days from T1D diagnosis to randomization, RCT intensive/standard care group, and clinical site.|||4|-6|0.74
72381515|NCT04233034|144271365|SUPERIORITY||Mean Difference (Final Values)|0.06||||0.23|TWO_SIDED|95.0|-0.04|0.17|||Regression, Linear||Mean difference (HCL - Non-HCL) at 52 weeks adjusted for age, days from T1D diagnosis to randomization, RCT drug group, and clinical site.|||0.17|-0.04|0.23
72434032|NCT00606580|144381636|NON_INFERIORITY_OR_EQUIVALENCE|The comparison of WR 279,396 versus Paromomycin Alone would be considered statistically significant if p \< .05.||||||0.83|||||||Log Rank|||||||0.830
72434033|NCT00606580|144381641|SUPERIORITY_OR_OTHER|||||||0.0001|||||||Chi-squared|||||||0.0001
72434034|NCT00606580|144381641|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Chi-squared|||||||<0.0001
72434035|NCT00606580|144381641|NON_INFERIORITY_OR_EQUIVALENCE|Test of H02: If H01 was rejected, then H02 would be tested. The comparison of WR 279,396 versus Paromomycin Alone would be considered statistically significant if p \< .05.||||||0.725|||||||Chi-squared|||||||0.725
72434036|NCT00606580|144381642|SUPERIORITY_OR_OTHER|||||||0.005|||||||Chi-squared|||||||0.005
72434037|NCT00606580|144381642|SUPERIORITY_OR_OTHER|||||||0.005|||||||Chi-squared|||||||0.005
72434038|NCT00606580|144381642|NON_INFERIORITY_OR_EQUIVALENCE|Test of H02: If H01 was rejected, then H02 would be tested. The comparison of WR 279,396 versus Paromomycin Alone would be considered statistically significant if p \< .05.||||||1|||||||Chi-squared|||||||1.000
72434039|NCT00606580|144381643|SUPERIORITY_OR_OTHER|||||||0.003|||||||Chi-squared|||||||0.003
72434040|NCT00606580|144381643|SUPERIORITY_OR_OTHER|||||||0.002|||||||Chi-squared|||||||0.002
72434041|NCT00606580|144381643|NON_INFERIORITY_OR_EQUIVALENCE|Test of H02: If H01 was rejected, then H02 would be tested. The comparison of WR 279,396 versus Paromomycin Alone would be considered statistically significant if p \< .05.||||||0.893|||||||Chi-squared|||||||0.893
72434042|NCT00606580|144381644|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Chi-squared|||||||<0.001
72434043|NCT00606580|144381644|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Chi-squared|||||||<0.001
72504711|NCT01954628|144540210|SUPERIORITY_OR_OTHER||Least sqaure mean difference|23.7||||0.759|TWO_SIDED|95.0|-128.3|175.7||AAC were compared between treatments using an analysis of variance model adjusting for treatment and region as factors and including the baseline score as a covariate.|ANOVA|||Sample size based on area above the daily EXACT score curve (AAC) from Day 1 to Day 29 from subjects with an acute COPD exacerbation, collected over 28 days. Assuming a residual SD of 500 points, a sample size of 200 subjects per arm would be expected to have an 80% power to detect a true treatment difference in the AAC of 140 points over 12-weeks treatment, using a 2-sided test; alpha-level of 0.05.This difference corresponds to a mean daily improvement of 1.67 points on the EXACT symptom score||175.7|-128.3|0.759
72434044|NCT00606580|144381644|NON_INFERIORITY_OR_EQUIVALENCE|The comparison of WR 279,396 versus Paromomycin Alone would be considered statistically significant if p \< .05.||||||0.247|||||||Chi-squared|||||||0.247
72434045|NCT00606580|144381645|SUPERIORITY_OR_OTHER|||||||0.409|||||||Chi-squared|||||||0.409
72434046|NCT00606580|144381645|SUPERIORITY_OR_OTHER|||||||0.651|||||||Chi-squared|||||||0.651
72434047|NCT00606580|144381645|NON_INFERIORITY_OR_EQUIVALENCE|The comparison of WR 279,396 versus Paromomycin Alone would be considered statistically significant if p \< .05.||||||0.701|||||||Chi-squared|||||||0.701
72434048|NCT00667693|144381676|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.35|||<|0.001|TWO_SIDED|95.0|0.23|0.55|||Regression, Cox|||||0.55|0.23|<0.001
72434049|NCT02020018|144381681|SUPERIORITY|||||||0.55|||||||Fisher Exact|||||||0.55
72434050|NCT04044664|144381684|OTHER|||||||0.1728|||||||t-test, 1 sided|||CAPS-5 Total Score||||0.1728
72434051|NCT04044664|144381684|OTHER|||||||0.0962|||||||t-test, 1 sided|||Cognition and Mood sub-score||||0.0962
72434052|NCT04044664|144381684|OTHER|||||||0.0191|||||||t-test, 1 sided|||Arousal and Reactivity sub-score||||0.0191
72434053|NCT04044664|144381690|OTHER|||||||0.0452|||||||t-test, 1 sided|||||||0.0452
72434054|NCT04044664|144381690|OTHER|||||||0.0614|||||||t-test, 1 sided|||||||0.0614
72434055|NCT04044664|144381691|OTHER|||||||0.0182|||||||t-test, 1 sided|||greater than or equal to 30% decrease from baseline||||0.0182
72434056|NCT04044664|144381691|OTHER|||||||0.0705|||||||t-test, 1 sided|||greater than or equal to 50% decrease from baseline||||0.0705
72434057|NCT03736785|144381693|EQUIVALENCE|Equivalence margin is zero.|||||<|0.001||||||P-value reported is within group comparison between Week 32 and baseline.|Mixed Models Analysis|||||||<0.001
72434058|NCT03736785|144381693|EQUIVALENCE|Equivalence margin is zero.|||||<|0.001||||||P-value reported is within group comparison between Week 32 and baseline.|Mixed Models Analysis|||||||<0.001
72434059|NCT03736785|144381693|EQUIVALENCE|Equivalence margin is zero.|||||<|0.001||||||P-value reported is within group comparison between Week 32 and baseline.|Mixed Models Analysis|||||||<0.001
72434060|NCT03736785|144381694|NON_INFERIORITY|Non-inferiority margin is 0.4%|LSMean Difference|0.08|||||TWO_SIDED|90.0|-0.11|0.28|||Mixed Models Analysis|||||0.28|-0.11|
72434061|NCT03736785|144381694|NON_INFERIORITY|Non-inferiority margin is 0.4%|LSMean Difference|0.09|||||TWO_SIDED|90.0|-0.1|0.29|||Mixed Models Analysis|||||0.29|-0.10|
72434062|NCT01549652|144381721|SUPERIORITY_OR_OTHER|||||||0.87||||||Students' t-tests for paired samples with Bonferroni correction for multiple comparisons were used to compare differences between the outcome measures for crossover treatment arms (placebo vs. ondansetron).|t-test, 2 sided|||For the purposes of our post-hoc power calculation we considered a 30% treatment effect clinically significant. Based on the mean observed OOWS score during withdrawal during the placebo session and the variance of that mean score and assuming a paired data analysis and an alpha of 0.05, we found that we had 80% power to detect a treatment effect as low as 25% reduction in OOWS.||||0.87
72434063|NCT01549652|144381722|SUPERIORITY_OR_OTHER|||||||0.92|||||||t-test, 2 sided|||||||0.92
72434064|NCT01549652|144381723|SUPERIORITY_OR_OTHER|||||||0.47|||||||t-test, 2 sided|||||||0.47
72434065|NCT01549652|144381724|SUPERIORITY_OR_OTHER|||||||0.91|||||||t-test, 2 sided|||||||0.91
72434066|NCT01549652|144381725|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
72434067|NCT01549652|144381726|SUPERIORITY_OR_OTHER|||||||0.003|||||||t-test, 2 sided|||||||0.003
72434068|NCT01549652|144381727|SUPERIORITY_OR_OTHER|||||||0.6||||||Students' t-test for paired samples were used to compare differences between the outcome measures for treatment groups (placebo vs. ondansetron).|t-test, 2 sided|||We aimed for a 20% change in OOWS score to show the treatment effect with a power of 80% and an alpha of 0.05, yielding a target of 23 patients per treatment group.||||0.6
72434069|NCT01549652|144381728|SUPERIORITY_OR_OTHER|||||||0.2|||||||t-test, 2 sided|||||||0.20
72434070|NCT01549652|144381729|SUPERIORITY_OR_OTHER|||||||0.34|||||||t-test, 2 sided|||||||0.34
72434071|NCT01549652|144381730|SUPERIORITY_OR_OTHER|||||||0.4|||||||t-test, 2 sided|||||||0.40
72434072|NCT01549652|144381731|SUPERIORITY_OR_OTHER|||||||0.84|||||||t-test, 2 sided|||||||0.84
72434073|NCT01549652|144381732|SUPERIORITY_OR_OTHER|||||||0.02|||||||t-test, 2 sided|||||||0.02
72556620|NCT03602339|144644401|NON_INFERIORITY|"The score to evaluate the non-inferiority is calculated for each subject as (combined unenhanced/gadobutrol-enhanced - unenhanced) - 0.8\*(combined unenhanced/gadoterate-enhanced - unenhanced). The 95% CI is based on a t-distribution. The non-inferiority for gadobutrol is achieved if the one-sided p-value for H0: (gadobutrol minus unenhanced) - 0.8\*(gadoterate minus unenhanced) ≤ 0 is lower than 0.025."|Mean Difference (Final Values)|0.455|||<|0.0001|TWO_SIDED|95.0|0.347|0.562||No type I error adjustment for multiple comparisons is needed because tests on all 3 primary efficacy variables must be significant to demonstrate primary efficacy.|Paired t-test|||Difference (gadobutrol minus unenhanced) - (gadoterate minus unenhanced)||0.562|0.347|< 0.0001
72556621|NCT03602339|144644402|NON_INFERIORITY|"The score to evaluate the non-inferiority is calculated for each subject as (combined unenhanced/gadobutrol-enhanced - unenhanced) - 0.8\*(combined unenhanced/gadoterate-enhanced - unenhanced). The 95% CI is based on a t-distribution. The non-inferiority for gadobutrol is achieved if the one-sided p-value for H0: (gadobutrol minus unenhanced) - 0.8\*(gadoterate minus unenhanced) ≤ 0 is lower than 0.025."|Mean Difference (Final Values)|0.18|||=|0.0151|TWO_SIDED|95.0|0.017|0.342||No type I error adjustment for multiple comparisons is needed because tests on all 3 primary efficacy variables must be significant to demonstrate primary efficacy.|Paired t-test|||Difference (gadobutrol minus unenhanced) - (gadoterate minus unenhanced)||0.342|0.017|= 0.0151
72556622|NCT03602339|144644403|NON_INFERIORITY|"The score to evaluate the non-inferiority is calculated for each subject as (combined unenhanced/gadobutrol-enhanced - unenhanced) - 0.8\*(combined unenhanced/gadoterate-enhanced - unenhanced). The 95% CI is based on a t-distribution. The non-inferiority for gadobutrol is achieved if the one-sided p-value for H0: (gadobutrol minus unenhanced) - 0.8\*(gadoterate minus unenhanced) ≤ 0 is lower than 0.025."|Mean Difference (Final Values)|0.15|||=|0.01|TWO_SIDED|95.0|0.024|0.275||No type I error adjustment for multiple comparisons is needed because tests on all 3 primary efficacy variables must be significant to demonstrate primary efficacy.|Paired t-test|||Difference (gadobutrol minus unenhanced) - (gadoterate minus unenhanced)||0.275|0.024|= 0.0100
72556623|NCT03602339|144644404|NON_INFERIORITY|Non-inferiority margin is 0.35. If the lower limit of the 95% CI is \> -0.35, then non-inferiority is achieved.|Mean Difference (Final Values)|0.073|||||TWO_SIDED|95.0|-0.03|0.176||||||Difference (Gadobutrol - Gadoterate)||0.176|-0.030|
72556624|NCT03602339|144644405|NON_INFERIORITY|Non-inferiority margin = 10%, if the lower limit of the confidence interval \> -10%, then non-inferiority is achieved.|Difference (Gadobutrol - Gadoterate)|0.0|||||TWO_SIDED|95.0|-3.4|3.4|||||The 95% confidence intervals are based on McNemar's test.|Accuracy Difference (Gadobutrol - Gadoterate)||3.40|-3.40|
72381516|NCT04233034|144271365|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.79|TWO_SIDED|95.0|-1.0|0.6|||Regression, Linear||Mean difference (Verapamil - Placebo) at 52 weeks adjusted for age, days from T1D diagnosis to randomization, RCT intensive/standard care group, and clinical site.|||0.6|-1.0|0.79
72434074|NCT02512042|144381733|EQUIVALENCE|The limits of each two-sided 95% confidence interval of the treatment difference (test-reference) for mean IOP of both eyes at approximately 8:00 (hours 0, before the morning drop) at the Day 14 visit should be within +/-1.5mm Hg, and should be within +/-1.0mm Hg for majority of time points using the PP population.|Mean Difference (Net)|-0.36|||||TWO_SIDED|95.0|-0.69|-0.03||||||||-0.03|-0.69|
72434075|NCT02512042|144381733|EQUIVALENCE|The limits of each two-sided 95% confidence interval of the treatment difference (test-reference) for mean IOP of both eyes at approximately 8:00 hour on Day 42 should be within +/-1.5mm Hg, and should be within +/- 1.0mm Hg for majority of time points using the PP population.|Mean Difference (Net)|-0.11|||||TWO_SIDED|95.0|-0.43|0.22||||||||0.22|-0.43|
72556625|NCT03602339|144644405|NON_INFERIORITY|Non-inferiority margin = 10%, if the lower limit of the confidence interval \> -10%, then non-inferiority is achieved.|Difference (Gadobutrol - Gadoterate)|0.0|||||TWO_SIDED|95.0|-5.22|5.22|||||The 95% confidence intervals are based on McNemar's test.|Sensitivity Difference (Gadobutrol - Gadoterate)||5.22|-5.22|
72556626|NCT03602339|144644405|NON_INFERIORITY|Non-inferiority margin = 10%, if the lower limit of the confidence interval \> -10%, then non-inferiority is achieved.|Difference (Gadobutrol - Gadoterate)|0.0|||||TWO_SIDED|95.0|0.0|0.0|||||The 95% confidence intervals are based on McNemar's test. No continuity correction for calculation of the confidence interval was included. Zero cells lead to degenerated confidence interval.|Specificity Difference (Gadobutrol - Gadoterate)||0.00|0.00|
72556627|NCT03602339|144644406|OTHER||Mean Difference (Final Values)|0.076|||||TWO_SIDED|95.0|0.011|0.14||||||Difference (Gadobutrol - Gadoterate)||0.140|0.011|
72381517|NCT04233034|144271366|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.39|TWO_SIDED|95.0|-0.3|0.7|||Regression, Linear||Mean difference (HCL - Non-HCL) at 52 weeks adjusted for age, days from T1D diagnosis to randomization, RCT drug group, and clinical site.|||0.7|-0.3|0.39
72556628|NCT03602339|144644407|OTHER||Mean Difference (Final Values)|0.0||||0.9149|TWO_SIDED|95.0|-0.1|0.11|||Wilcoxon signed-rank test|||Comparison of image quality between gadobutrol and gadoterate||0.11|-0.10|0.9149
72556629|NCT03602339|144644408|OTHER||Mean Difference (Final Values)|-0.01968|||||TWO_SIDED|95.0|-0.03491|-0.00445||||||Difference (Gadobutrol-Gadoterate) for Relative score||-0.00445|-0.03491|
72556630|NCT03602339|144644408|OTHER||Mean Difference (Final Values)|0.00586|||||TWO_SIDED|95.0|-0.00589|0.01762||||||Difference (Gadobutrol-Gadoterate) for Full image score||0.01762|-0.00589|
72556631|NCT03602339|144644408|OTHER||Mean Difference (Final Values)|0.00139|||||TWO_SIDED|95.0|-0.00471|0.00749||||||Difference (Gadobutrol-Gadoterate) for Dice score||0.00749|-0.00471|
72381518|NCT04233034|144271366|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.74|TWO_SIDED|95.0|-1.0|0.6|||Regression, Linear||Mean difference (Verapamil - Placebo) at 52 weeks adjusted for age, days from T1D diagnosis to randomization, RCT intensive/standard care group, and clinical site.|||0.6|-1.0|0.74
72434076|NCT02512042|144381733|EQUIVALENCE|The limits of each two-sided 95% confidence interval of the treatment difference (test-reference) for mean IOP of both eyes at approximately 10:00 hour on Day 14 should be within +/-1.5mm Hg, and should be within +/-1.0mm Hg for majority of time points using the PP population.|Mean Difference (Net)|-0.4|||||TWO_SIDED|95.0|-0.71|-0.09||||||||-0.09|-0.71|
72434077|NCT02512042|144381733|EQUIVALENCE|The limits of each two-sided 95% confidence interval of the treatment difference (test-reference) for mean IOP of both eyes at approximately 10:00 hour on Day 42 should be within +/-1.5mm Hg, and should be within +/-1.0mm Hg for majority of time points using the PP population|Mean Difference (Net)|-0.19|||||TWO_SIDED|95.0|-0.5|0.13||||||||0.13|-0.50|
72434078|NCT00964119|144381739|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|90.0||||P-value \< .05 is the computed p-value for this measurement.|t-test, 2 sided|||PI and lead author left the institution before publishing data. Study has been closed and data files archived.||||<.05
72434079|NCT03727854|144381740|SUPERIORITY|||||||0.933|||||||t-test, 2 sided|||||||0.933
72434080|NCT03727854|144381741|SUPERIORITY|||||||0.971|||||||t-test, 2 sided|||||||0.971
72434081|NCT03727854|144381742|SUPERIORITY|||||||0.608|||||||t-test, 2 sided|||||||0.608
72434082|NCT03727854|144381743|SUPERIORITY|||||||0.617|||||||t-test, 2 sided|||||||0.617
72434083|NCT03727854|144381744|SUPERIORITY|||||||0.823|||||||t-test, 2 sided|||||||0.823
72434084|NCT03727854|144381745|SUPERIORITY|||||||0.74|||||||t-test, 2 sided|||||||0.740
72434085|NCT03727854|144381746|SUPERIORITY|||||||0.551|||||||t-test, 2 sided|||||||0.551
72434086|NCT03727854|144381747|SUPERIORITY|||||||0.652|||||||t-test, 2 sided|||||||0.652
72434087|NCT03727854|144381748|SUPERIORITY|||||||0.639|||||||t-test, 2 sided|||||||0.639
72434088|NCT01078246|144381749|SUPERIORITY_OR_OTHER||Incidence Rate Ratio|2.282||||0.002|TWO_SIDED|95.0|1.344|3.875|||Poisson Regression|The analysis included adjustments for raltegravir exposure, propensity score, and treatment regimen (1st, 2nd, 3rd+).||AIDS-defining malignancies||3.875|1.344|0.002
72434089|NCT01078246|144381749|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.84|||<|0.05|TWO_SIDED|95.0|1.621|4.977|||Cox Proportional Hazard Regression|The analysis included adjustments for raltegravir exposure, propensity score, and treatment regimen (1st, 2nd, 3rd+).||AIDS-defining malignancies||4.977|1.621|<0.05
72434090|NCT01078246|144381749|SUPERIORITY_OR_OTHER||Incidence Rate Ratio|1.871||||0.005|TWO_SIDED|95.0|1.207|2.899|||Poisson Regression|The analysis included adjustments for raltegravir exposure, propensity score, and treatment regimen (1st, 2nd, 3rd+).||AIDS-defining malignancies||2.899|1.207|0.005
72434091|NCT01078246|144381749|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.879||||0.004|TWO_SIDED|95.0|1.227|2.879|||Cox Proportional Hazard Regression|The analysis included adjustments for raltegravir exposure, propensity score, and treatment regimen (1st, 2nd, 3rd+).||AIDS-defining malignancies||2.879|1.227|0.004
72434092|NCT01078246|144381749|SUPERIORITY_OR_OTHER||Incidence Rate Ratio|1.943||||0.008|TWO_SIDED|95.0|1.191|3.168|||Poisson Regression|The analysis included adjustments for raltegravir exposure, propensity score, and treatment regimen (1st, 2nd, 3rd+).||Non-AIDS-defining malignancies||3.168|1.191|0.008
72434093|NCT01078246|144381749|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.459||||0.001|TWO_SIDED|95.0|1.454|4.159|||Cox Proportional Hazard Regression|The analysis included adjustments for raltegravir exposure, propensity score, and treatment regimen (1st, 2nd, 3rd+).||Non-AIDS-defining malignancies||4.159|1.454|0.001
72556632|NCT03602339|144644410|EQUIVALENCE|An equivalence test was calculated using the two one-sided t-tests (TOST) procedure with null hypotheses H01: (gadobutrol - gadoterate) ≤ -0.05 \* (gadoterate), and H02: (gadobutrol - gadoterate) ≥ +0.05 \* (gadoterate).||||||0.0049||||||The overall p-value was calculated as max(p1, p2) where p1 and p2 are the results of null hypotheses H01 and H02 respectively.|Two one-sided t-tests (TOST)|||||||0.0049
72556633|NCT03602339|144644411|EQUIVALENCE|An equivalence test was calculated using the two one-sided t-tests (TOST) procedure with null hypotheses H01: (gadobutrol - gadoterate) ≤ -0.05 \* (gadoterate) and H02: (gadobutrol - gadoterate) ≥ +0.05 \* (gadoterate).||||||0.0013||||||The overall p-value was calculated as max(p1, p2) where p1 and p2 are the results of null hypotheses H01 and H02 respectively.|Two one-sided t-tests (TOST)|||||||0.0013
72434094|NCT01078246|144381749|SUPERIORITY_OR_OTHER||Incidence Rate Ratio|1.776||||0.004|TWO_SIDED|95.0|1.199|2.631|||Poisson Regression|The analysis included adjustments for raltegravir exposure, propensity score, and treatment regimen (1st, 2nd, 3rd+).||Non-AIDS-defining malignancies||2.631|1.199|0.004
72434095|NCT01078246|144381749|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.86||||0.001|TWO_SIDED|95.0|1.274|2.717|||Cox Proportional Hazard Regression|The analysis included adjustments for raltegravir exposure, propensity score, and treatment regimen (1st, 2nd, 3rd+).||Non-AIDS-defining malignancies||2.717|1.274|0.001
72434096|NCT01078246|144381750|SUPERIORITY_OR_OTHER||Incidence Rate Ratio|0.807||||0.255|TWO_SIDED|95.0|0.557|1.168|||Poisson regression|The analysis included adjustments for raltegravir exposure, propensity score, treatment regimen (1st, 2nd, 3rd+), and Hepatitis B/C status.||||1.168|0.557|0.255
72434097|NCT01078246|144381750|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.907||||0.646|TWO_SIDED|95.0|0.597|1.376|||Cox Proportional Hazard Regression|The analysis included adjustments for raltegravir exposure, propensity score, treatment regimen (1st, 2nd, 3rd+), and Hepatitis B/C status.||||1.376|0.597|0.646
72434098|NCT01078246|144381750|SUPERIORITY_OR_OTHER||Incidence Rate Ratio|1.268||||0.182|TWO_SIDED|95.0|0.895|1.795|||Poisson Regression|The analysis included adjustments for raltegravir exposure, propensity score, treatment regimen (1st, 2nd, 3rd+), and Hepatitis B/C status.||||1.795|0.895|0.182
72434099|NCT01078246|144381750|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.257||||0.188|TWO_SIDED|95.0|0.894|1.768|||Cox Proportional Hazard Regression|The analysis included adjustments for raltegravir exposure, propensity score, treatment regimen (1st, 2nd, 3rd+), and Hepatitis B/C status.||||1.768|0.894|0.188
72434100|NCT01078246|144381751|SUPERIORITY_OR_OTHER||Incidence Rate Ratio|1.016||||0.897|TWO_SIDED|95.0|0.796|1.297|||Poisson Regression|The analysis included adjustments for raltegravir exposure, propensity score, and treatment regimen (1st, 2nd, 3rd+).||||1.297|0.796|0.897
72434101|NCT01078246|144381751|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.287||||0.07|TWO_SIDED|95.0|0.98|1.69|||Cox Proportional Hazard Regression|The analysis included adjustments for raltegravir exposure, propensity score, and treatment regimen (1st, 2nd, 3rd+).||||1.690|0.980|0.070
72434102|NCT01078246|144381751|SUPERIORITY_OR_OTHER||Incidence Rate Ratio|1.067||||0.575|TWO_SIDED|95.0|0.85|1.339|||Poisson Regression|The analysis included adjustments for raltegravir exposure, propensity score, and treatment regimen (1st, 2nd, 3rd+).||||1.339|0.850|0.575
72434103|NCT01078246|144381751|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.057||||0.626|TWO_SIDED|95.0|0.847|1.319|||Cox Proportional Hazard Regression|The analysis included adjustments for raltegravir exposure, propensity score, and treatment regimen (1st, 2nd, 3rd+).||||1.319|0.847|0.626
72434104|NCT01078246|144381753|SUPERIORITY_OR_OTHER||Incidence Rate Ratio|0.389|||<|0.0001|TWO_SIDED|95.0|0.274|0.551|||Poisson Regression|The analysis included adjustments for raltegravir exposure, propensity score, and treatment regimen (1st, 2nd, 3rd+).||||0.551|0.274|<0.0001
72556634|NCT03602339|144644412|EQUIVALENCE|An equivalence test was calculated using the two one-sided t-tests (TOST) procedure with null hypotheses H01: (gadobutrol - gadoterate) ≤ -0.05 \* (gadoterate) and H02: (gadobutrol - gadoterate) ≥ +0.05 \* (gadoterate).||||||0.0065||||||The overall p-value was calculated as max(p1, p2) where p1 and p2 are the results of null hypotheses H01 and H02 respectively.|Two one-sided t-tests (TOST)|||||||0.0065
72556635|NCT00834275|144644433|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model containing factors for sequence of products, subjects within sequence, periods, and products was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|99.0||||||90.0|94.0|104.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%|||104|94|
72556636|NCT00834275|144644434|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model containing factors for sequence of products, subjects within sequence, periods, and products was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|101.0||||||90.0|98.3|105.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%|||105|98.3|
72556637|NCT00834275|144644435|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model containing factors for sequence of products, subjects within sequence, periods, and products was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|101.0||||||90.0|98.3|104.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%|||104|98.3|
72556638|NCT01030133|144644438|SUPERIORITY_OR_OTHER|||||||0.05|||||||Chi-squared|0.75||||||0.05
72556639|NCT04517604|144644468|SUPERIORITY||Mean Difference (Final Values)|-5.02|STANDARD_DEVIATION|4.984||0.343|TWO_SIDED|95.0|-16.52|6.47||no adjustment for multiple comparisons as was a pilot|Mixed Models Analysis|||||6.47|-16.52|.343
72381519|NCT04233034|144271368|SUPERIORITY||Mean Difference (Final Values)|-0.7|||<|0.001|TWO_SIDED|95.0|-1.1|-0.3|||Mixed Models Analysis||Mean difference (HCL - Non-HCL) at 52 weeks adjusted for age, days from T1D diagnosis to randomization, RCT drug group, and clinical site.|||-0.3|-1.1|<0.001
72381520|NCT04233034|144271368|SUPERIORITY||Mean Difference (Final Values)|-0.3||||0.65|TWO_SIDED|95.0|-1.0|0.4|||Mixed Models Analysis||Mean difference (Verapamil - Placebo) at 52 weeks adjusted for age, days from T1D diagnosis to randomization, RCT intensive/standard care group, and clinical site.|||0.4|-1.0|0.65
72381521|NCT04233034|144271371|SUPERIORITY||Mean Difference (Final Values)|0.09||||0.07|TWO_SIDED|95.0|-0.01|0.2|||Mixed Models Analysis||Mean difference (HCL - Non-HCL) at 52 weeks adjusted for age, days from T1D diagnosis to randomization, RCT drug group, and clinical site.|||0.20|-0.01|0.07
72381522|NCT04233034|144271371|SUPERIORITY||Mean Difference (Final Values)|-0.12||||0.52|TWO_SIDED|95.0|-0.3|0.05|||Mixed Models Analysis||Mean difference (Verapamil - Placebo) at 52 weeks adjusted for age, days from T1D diagnosis to randomization, RCT intensive/standard care group, and clinical site.|||0.05|-0.30|0.52
72381523|NCT01865084|144271408|SUPERIORITY_OR_OTHER_LEGACY|||||||0.307||||||The p-value is based on the treatment difference LS Mean changes from baseline between tadalafil and placebo.|Mixed Models Analysis|||||||0.307
72556640|NCT04517604|144644469|SUPERIORITY|This was a pilot study funded under a pilot funding mechanism which specifically did not require a power analysis.|Mean Difference (Final Values)|-1.7|STANDARD_DEVIATION|0.42||0.0026|TWO_SIDED|95.0|-2.63|-0.77||no test for multiple comparisons as this was a pilot study|Mixed Models Analysis|||This was an open-label, single group study using a within subject design. We compared pre-treatment values to post-treatment values.||-.77|-2.63|.0026
72381524|NCT01865084|144271408|SUPERIORITY_OR_OTHER_LEGACY|||||||0.538||||||The p-value is based on the treatment difference LS Mean changes from baseline between tadalafil and placebo.|Mixed Models Analysis|||||||0.538
72381525|NCT04824365|144271447|SUPERIORITY||Mean Difference (Final Values)|-0.3379|STANDARD_ERROR_OF_MEAN|0.1438||0.0197|TWO_SIDED|95.0|-0.6213|-0.0545|||ANOVA|two-way ANOVA||||-0.0545|-0.6213|0.0197
72381526|NCT04824365|144271448|SUPERIORITY||Mean Difference (Final Values)|0.0381|STANDARD_ERROR_OF_MEAN|0.1129||0.736|TWO_SIDED|95.0|-0.1843|0.2605|||ANOVA|Two-way ANOVA||||0.2605|-0.1843|0.736
72556641|NCT02635750|144644470|OTHER||Adjusted gMean ratio(%)|99.95|||||TWO_SIDED|90.0|89.502|111.62|||||"Ratio of BI 409306 25mg with donepezil 10mg and BI 409306 25mg alone (BI 409306+ don / BI 409306).~Intra-individual coefficient of variation (gCV (%)) = 18.6."|"The statistical model used for the analysis of those endpoints was an analysis of variance (ANOVA) model on the logarithmic scale (natural logarithm). This model included effects accounting for the following sources of variation: 'subjects' and 'treatment'. The effect 'subjects' was considered as random, whereas the other effect was considered as fixed.~Abbreviations used: geometric mean (gMean), donepezil (don)"||111.62|89.502|
72618634|NCT01026038|144768106|SUPERIORITY_OR_OTHER||GMC ratio|3.11|||||TWO_SIDED|95.0|2.23|4.33||||||Serotype 7F: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||4.33|2.23|
72381527|NCT04824365|144271449|SUPERIORITY||Mean Difference (Final Values)|0.3131|STANDARD_ERROR_OF_MEAN|0.1049||0.003|TWO_SIDED|95.0|0.1069|0.5193|||ANOVA|Two-way ANOVA||||0.5193|0.1069|0.0030
72381528|NCT04824365|144271450|SUPERIORITY||Mean Difference (Final Values)|1.704|STANDARD_ERROR_OF_MEAN|0.3035|<|0.0001|TWO_SIDED|95.0|1.105|2.302|||ANOVA|Two-way ANOVA||||2.302|1.105|<0.0001
72381529|NCT04824365|144271451|SUPERIORITY||Mean Difference (Final Values)|1.633|STANDARD_ERROR_OF_MEAN|0.3362|<|0.0001|TWO_SIDED|95.0|0.9672|2.298|||ANOVA|Two-way ANOVA||||2.298|0.9672|<0.0001
72381530|NCT04824365|144271452|SUPERIORITY||Mean Difference (Final Values)|1.964|STANDARD_ERROR_OF_MEAN|0.2473|<|0.0001|TWO_SIDED|95.0|1.477|2.452|||ANOVA|Two-way ANOVA||||2.452|1.477|<0.0001
72618635|NCT01026038|144768106|SUPERIORITY_OR_OTHER||GMC ratio|0.84|||||TWO_SIDED|95.0|0.61|1.17||||||Serotype 7F: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.17|0.61|
72434105|NCT01078246|144381753|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.471|||<|0.05|TWO_SIDED|95.0|0.314|0.707|||Cox Proportional Hazard Regression|The analysis included adjustments for raltegravir exposure, propensity score, and treatment regimen (1st, 2nd, 3rd+).||||0.707|0.314|<0.05
72434106|NCT01078246|144381753|SUPERIORITY_OR_OTHER||Incidence Rate Ratio|1.65||||0.015|TWO_SIDED|95.0|1.102|2.47|||Poisson Regression|The analysis included adjustments for raltegravir exposure, propensity score, and treatment regimen (1st, 2nd, 3rd+).||||2.470|1.102|0.015
72434107|NCT01078246|144381753|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.622||||0.018|TWO_SIDED|95.0|1.085|2.425|||Cox Proportional Hazard Regression|The analysis included adjustments for raltegravir exposure, propensity score, and treatment regimen (1st, 2nd, 3rd+).||||2.425|1.085|0.018
72434108|NCT01078246|144381754|SUPERIORITY_OR_OTHER||Incidence Rate Ratio|0.75||||0.423|TWO_SIDED|95.0|0.37|1.517|||Poisson Regression|The analysis included adjustments for raltegravir exposure, propensity score, and treatment regimen (1st, 2nd, 3rd+).||||1.517|0.370|0.423
72434109|NCT01078246|144381754|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.208||||0.631|TWO_SIDED|95.0|0.559|2.612|||Cox Proportional Hazard Regression|The analysis included adjustments for raltegravir exposure, propensity score, and treatment regimen (1st, 2nd, 3rd+).||||2.612|0.559|0.631
72434110|NCT01078246|144381754|SUPERIORITY_OR_OTHER||Incidence Rate Ratio|0.845||||0.592|TWO_SIDED|95.0|0.458|1.561|||Poisson Regression|The analysis included adjustments for raltegravir exposure, propensity score, and treatment regimen (1st, 2nd, 3rd+).||||1.561|0.458|0.592
72434111|NCT01078246|144381754|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.022||||0.943|TWO_SIDED|95.0|0.565|1.85|||Cox Proportional Hazard Regression|The analysis included adjustments for raltegravir exposure, propensity score, and treatment regimen (1st, 2nd, 3rd+).||||1.850|0.565|0.943
72434112|NCT01078246|144381755|SUPERIORITY_OR_OTHER||Incidence Rate Ratio|0.708||||0.109|TWO_SIDED|95.0|0.464|1.08|||Poisson Regression|The analysis included adjustments for raltegravir exposure, propensity score, and treatment regimen (1st, 2nd, 3rd+).||||1.080|0.464|0.109
72434113|NCT01078246|144381755|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.794||||0.356|TWO_SIDED|95.0|0.486|1.296|||Cox Proportional Hazard Regression|The analysis included adjustments for raltegravir exposure, propensity score, and treatment regimen (1st, 2nd, 3rd+).||||1.296|0.486|0.356
72434114|NCT01078246|144381755|SUPERIORITY_OR_OTHER||Incidence Rate Ratio|1.556||||0.039|TWO_SIDED|95.0|1.022|2.37|||Poisson Regression|The analysis included adjustments for raltegravir exposure, propensity score, and treatment regimen (1st, 2nd, 3rd+).||||2.370|1.022|0.039
72381531|NCT04824365|144271453|SUPERIORITY||Mean Difference (Final Values)|-0.4831|STANDARD_ERROR_OF_MEAN|0.2382||0.0435|TWO_SIDED|95.0|-0.9521|-0.01413|||ANOVA|Two-way ANOVA||||-0.01413|-0.9521|0.0435
72434115|NCT01078246|144381755|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.564||||0.033|TWO_SIDED|95.0|1.036|2.361|||Cox Proportional Hazard Regression|The analysis included adjustments for raltegravir exposure, propensity score, and treatment regimen (1st, 2nd, 3rd+).||||2.361|1.036|0.033
72556642|NCT02635750|144644471|OTHER||Adjusted gMean ratio(%)|100.82|||||TWO_SIDED|90.0|81.861|124.17|||||Ratio of BI 409306 25mg with donepezil 10mg and BI 409306 25mg alone (BI 409306+don / BI 409306). Intra-individual coefficient of variation (gCV (%)) = 35.8.|"The statistical model used for the analysis of those endpoints was an analysis of variance (ANOVA) model on the logarithmic scale (natural logarithm). This model included effects accounting for the following sources of variation: 'subjects' and 'treatment'. The effect 'subjects' was considered as random, whereas the other effect was considered as fixed.~Abbreviations used: geometric mean (gMean), donepezil (don)"||124.17|81.861|
72434116|NCT01078246|144381755|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.72||||0.125|TWO_SIDED|95.0|0.861|3.437|||Cox Proportional Hazard Regression|The analysis included adjustments for raltegravir exposure, and propensity score, and was stratified by the 1st treatment regimen.||||3.437|0.861|0.125
72434117|NCT01078246|144381755|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.056||||0.881|TWO_SIDED|95.0|0.517|2.155|||Cox Proportional Hazard Regression|The analysis included adjustments for raltegravir exposure, and propensity score, and was stratified by the 2nd treatment regimen.||||2.155|0.517|0.881
72618636|NCT01026038|144768106|SUPERIORITY_OR_OTHER||GMC ratio|0.27|||||TWO_SIDED|95.0|0.19|0.4||||||Serotype 7F: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||0.40|0.19|
72381532|NCT04824365|144271454|SUPERIORITY||Mean Difference (Final Values)|-0.05102|STANDARD_ERROR_OF_MEAN|0.2711||0.8509|TWO_SIDED|95.0|-0.5862|0.4841|||ANOVA|Two-way ANOVA||||0.4841|-0.5862|0.8509
72381533|NCT04824365|144271455|SUPERIORITY||Mean Difference (Final Values)|0.1339|STANDARD_ERROR_OF_MEAN|0.3177||0.6738|TWO_SIDED|95.0|-0.4921|0.76|||ANOVA|Two-way ANOVA||||0.7600|-0.4921|0.6738
72381534|NCT04824365|144271456|SUPERIORITY||Mean Difference (Final Values)|0.3095|STANDARD_ERROR_OF_MEAN|0.2832||0.2753|TWO_SIDED|95.0|-0.2478|0.8669|||ANOVA|Two-way ANOVA||||0.8669|-0.2478|0.2753
72381535|NCT04824365|144271457|SUPERIORITY||Mean Difference (Final Values)|-1.426|STANDARD_ERROR_OF_MEAN|0.2636|<|0.0001|TWO_SIDED|95.0|-1.948|-0.9043|||ANOVA|Two-way ANOVA||||-0.9043|-1.948|<0.0001
72434118|NCT01078246|144381755|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.077||||0.107|TWO_SIDED|95.0|0.854|5.05|||Cox Proportional Hazard Regression|The analysis included adjustments for raltegravir exposure, and propensity score, and was stratified by the 3rd+ treatment regimen.||||5.05|0.854|0.107
72434119|NCT01081145|144381756|SUPERIORITY_OR_OTHER_LEGACY||Difference in treatment failures|-15.6||||0.006|TWO_SIDED|95.0|-26.6|-4.5|||Cochran-Mantel-Haenszel|||||-4.5|-26.6|0.006
72434120|NCT01081145|144381757|SUPERIORITY_OR_OTHER_LEGACY|||||||0.003|||||||Log Rank|||||||0.003
72434121|NCT01081145|144381758|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Mean|-6.24|||<|0.001|TWO_SIDED|95.0|-9.01|-3.48||Nominal p-value uncorrected for multiplicity.|ANCOVA|||||-3.48|-9.01|<0.001
72434122|NCT01081145|144381759|SUPERIORITY_OR_OTHER_LEGACY||Difference in percent of subjects|17.5||||0.001|TWO_SIDED|95.0|6.6|28.5||Nominal p-value uncorrected for multiplicity.|Cochran-Mantel-Haenszel|||||28.5|6.6|0.001
72434123|NCT01081145|144381760|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Mean|-0.06||||0.118|TWO_SIDED|95.0|-0.14|0.02||Nominal p-value uncorrected for multiplicity.|ANCOVA|||||0.02|-0.14|0.118
72434124|NCT01081145|144381763|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||Nominal p-value uncorrected for multiplicity.|t-test, 2 sided|||||||<0.001
72434125|NCT01081145|144381767|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||Nominal p-value uncorrected for multiplicity.|t-test, 2 sided|||||||<0.001
72556643|NCT02635750|144644472|OTHER||Adjusted gMean ratio (%)|100.84|||||TWO_SIDED|90.0|97.584|104.19|||||Ratio of donepezil 5mg with BI 409306 100mg and donepezil 5mg alone (BI 409306+don / don). Intra-individual coefficient of variation (gCV (%)) = 4.9.|The PK endpoints were log transformed (natural logarithm) prior to fitting the ANOVA model. This model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'periods' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed. Abbreviations used: geometric mean (gMean), donepezil (don)||104.19|97.584|
72381536|NCT03463031|144271465|SUPERIORITY||Least Square Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.17||0.001|TWO_SIDED|95.0|-0.9|-0.2|||Mixed Models Analysis|||||-0.2|-0.9|0.001
72381537|NCT03463031|144271466|SUPERIORITY||Least Square Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.17|<|0.001|TWO_SIDED|95.0|-1.0|-0.3|||Mixed Models Analysis|||||-0.3|-1.0|<0.001
72381538|NCT03463031|144271467|SUPERIORITY||Least Square Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.09|<|0.001|TWO_SIDED|95.0|-0.5|-0.1|||ANCOVA|||||-0.1|-0.5|< 0.001
72381539|NCT03463031|144271468|SUPERIORITY||Least Square Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.19||0.233|TWO_SIDED|95.0|-0.6|0.1|||Mixed Models Analysis|||||0.1|-0.6|0.233
72381540|NCT00559754|144271553|SUPERIORITY_OR_OTHER|||||||0.4915|||||||Fisher Exact|||||||0.4915
72381541|NCT00559754|144271554|SUPERIORITY_OR_OTHER|||||||0.4864|||||||Chi-squared|||||||0.4864
72381542|NCT00559754|144271555|SUPERIORITY_OR_OTHER|||||||0.3613|||||||Fisher Exact|||||||0.3613
72381543|NCT00559754|144271556|SUPERIORITY_OR_OTHER|||||||0.6605|||||||Fisher Exact|||||||0.6605
72381544|NCT00559754|144271557|SUPERIORITY_OR_OTHER|||||||0.8311|||||||Fisher Exact|||||||0.8311
72381545|NCT00559754|144271558|SUPERIORITY_OR_OTHER|||||||0.223|||||||Fisher Exact|||||||0.2230
72381546|NCT00559754|144271559|SUPERIORITY_OR_OTHER|||||||0.8696|||||||Fisher Exact|||||||0.8696
72381547|NCT00559754|144271560|SUPERIORITY_OR_OTHER|||||||0.0074|||||||Fisher Exact|||||||0.0074
72381548|NCT00559754|144271561|SUPERIORITY_OR_OTHER|||||||0.3235|||||||Fisher Exact|||||||0.3235
72381549|NCT00559754|144271562|SUPERIORITY_OR_OTHER|||||||0.0693|||||||Fisher Exact|||||||0.0693
72381550|NCT00559754|144271564|SUPERIORITY_OR_OTHER|||||||0.4254|||||||Fisher Exact|||||||0.4254
72434126|NCT03593070|144381796|OTHER|Analyses compared changes in total scores for the MM-CGI from baseline to 24 weeks, for both arms of the intervention (CGMI-V and MT).|Slope|0.646|STANDARD_DEVIATION|0.622||0.001|TWO_SIDED|||||A priori alpha=0.05.|Regression, Linear|||||||0.001
72381551|NCT00559754|144271566|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||||||1.0000
72434127|NCT03593070|144381797|OTHER||Slope|0.444|STANDARD_DEVIATION|0.105||0.001|TWO_SIDED|||||A priori alpha=0.05.|Regression, Linear|||Analyses compared changes in total scores for the CESD from baseline to 24 weeks, for both arms of the intervention (CGMI-V and MT).||||0.001
72434128|NCT03593070|144381798|OTHER|Analyses compared changes in total State Trait Anxiety Inventory (STAI) scores from baseline to 24 weeks, for both arms of the intervention (CGMI-V and MT).|Slope|0.514|STANDARD_DEVIATION|0.102||0.001|TWO_SIDED|||||A priori alpha=0.05.|Regression, Linear|||||||0.001
72381552|NCT00559754|144271567|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||||||1.0000
72381553|NCT00559754|144271569|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||||||1.0000
72381554|NCT00701376|144271589|SUPERIORITY||Mean Difference (Net)|-6.32||||0.03|TWO_SIDED|99.8|-15.6|2.94|||paired t-test|||||2.94|-15.6|0.03
72381555|NCT00701376|144271590|SUPERIORITY||Mean Difference (Net)|-7.56||||0.08|TWO_SIDED|99.8|-22.0|6.83|||Wilcoxon (Mann-Whitney)|||||6.83|-22.0|0.08
72381556|NCT00701376|144271591|SUPERIORITY||Mean Difference (Net)|5.84||||0.14|TWO_SIDED|99.8|-7.55|19.2|||paired t-test|||||19.2|-7.55|0.14
72381557|NCT00701376|144271593|SUPERIORITY||Mean Difference (Net)|-0.2|||<|0.001|TWO_SIDED|99.8|-0.38|-0.02|||paired t-test|||||-0.02|-0.38|<0.001
72381558|NCT00701376|144271594|SUPERIORITY||Mean Difference (Net)|-0.23||||0.1|TWO_SIDED|99.8|-0.68|0.23|||paired t-test|||||0.23|-0.68|0.10
72381559|NCT00701376|144271595|SUPERIORITY||Mean Difference (Net)|-1.72||||0.21|TWO_SIDED|99.8|-8.68|5.25|||paired t-test|||||5.25|-8.68|0.21
72381560|NCT00701376|144271597|SUPERIORITY|||||||0.002|||||||Wilcoxon signed-rank test|||||||0.002
72381561|NCT00701376|144271598|SUPERIORITY|||||||0.04|||||||Wilcoxon signed-rank test|||||||0.04
72381562|NCT00701376|144271599|SUPERIORITY|||||||0.005|||||||Wilcoxon signed-rank test|||||||0.005
72381563|NCT00701376|144271600|SUPERIORITY|||||||0.001|||||||Wilcoxon signed-rank test|||||||0.001
72381564|NCT02537574|144271610|SUPERIORITY||Odds Ratio (OR)|1.02|STANDARD_ERROR_OF_MEAN|0.264||0.94|TWO_SIDED|95.0|0.61|1.7|||Regression, Logistic|||||1.70|0.61|0.940
72381565|NCT02537574|144271610|SUPERIORITY||Odds Ratio (OR)|0.8|STANDARD_ERROR_OF_MEAN|0.207||0.383|TWO_SIDED|95.0|0.48|1.33|||Regression, Logistic|||||1.33|0.48|0.383
72381566|NCT03595774|144271628|SUPERIORITY|||||||0.0833||||||a priori threshold for statistical significance of P\<0.05|ANOVA|One-way ANOVA for repeated measures followed by Holm-Šídák's multiple comparisons test||||||0.0833
72381567|NCT03595774|144271629|SUPERIORITY|||||||0.0131||||||a priori threshold for statistical significance of P\<0.05|ANOVA|One-way ANOVA for repeated measures followed by Holm-Šídák's multiple comparisons test||||||0.0131
72381568|NCT03595774|144271630|SUPERIORITY|||||||0.012728||||||a prior threshold for significant of P\<0.05|ANOVA|Two-way ANOVA for repeated measured followed by Holm-Šídák's multiple comparisons test||||||0.012728
72381569|NCT03595774|144271631|SUPERIORITY|||||||2e-08||||||a priori threshold for statistical significance of P\<0.05|ANOVA|Two-way ANOVA for repeated measures followed by Holm-Šídák's multiple comparisons test||||||0.00000002
72381570|NCT03595774|144271632|SUPERIORITY|||||||0.017215||||||a priori threshold for statistical significance of P\<0.05|ANOVA|Two-way ANOVA for repeated measures followed by Holm-Šídák's multiple comparisons test||||||0.017215
72381571|NCT01593722|144271634|SUPERIORITY_OR_OTHER|||||||0.68|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.68
72434129|NCT03593070|144381799|OTHER|Analyses compared changes in total positive state of mind scale (PSOMS) scores from baseline to 24 weeks, for both arms of the intervention (CGMI-V and MT).|Slope|0.653|STANDARD_DEVIATION|0.093||0.001|TWO_SIDED|||||A priori alpha=0.05.|Regression, Linear|||||||0.001
72434130|NCT03593070|144381800|OTHER|Analyses compared changes in conflict scores (based on FPCR) from baseline to 24 weeks, for both arms of the intervention (CGMI-V and MT)|Slope|0.609|STANDARD_DEVIATION|0.07||0.001|TWO_SIDED|||||A priori alpha=0.05.|Regression, Linear|||||||0.001
72381572|NCT02788474|144271653|OTHER||Adjusted mean difference|-0.00066|STANDARD_ERROR_OF_MEAN|0.00282||0.8146|TWO_SIDED|95.0|-0.00621|0.00488||random coefficient regression (random slopes and intercepts) model including sex, age and height as covariates (Due to the low number of measurements per patient, baseline CRPM was included as a response rather than as a covariate in the analysis)|random coefficient regression|The Kenward-Roger approximation was used to estimate denominators degrees of freedom.|Difference calculated as Nintedanib minus Placebo|"The rate of change (slope) in blood CRPM was assumed to be linear in each subject over the 12 weeks of treatment. The intercepts and slopes were assumed to be normally distributed with arbitrary covariance matrix.~Since the distribution of the data was not normal, a log10 transformation was performed before conducting the statistical analyses.~Significance tests were based on least-square means using 2-sided 95% confidence intervals (2-sided α=0.05)."||0.00488|-0.00621|0.8146
72381573|NCT02788474|144271654|OTHER||slope estimate|22.001||||0.2084|TWO_SIDED|95.0|-11.83|57.58|||Regression, Logistic||Slope estimate is the monthly rate of change in CRPM up to week 12|To assess the association between disease progression (as defined by absolute forced vital capacity (FVC) decline \>=10% or death) and the change in the Extracellular matrix (ECM) biomarker CRPM in the first 12 weeks, a logistic regression analysis including baseline blood CRPM and the monthly rate of change (slope) in blood CRPM in the first 12 weeks as covariates was applied for placebo-treated patients only to evaluate the potential of CRPM as a prognostic biomarker.||57.58|-11.83|0.2084
72381574|NCT02788474|144271654|OTHER||slope estimate|-45.566||||0.1537|TWO_SIDED|95.0|-109.55|16.37|||Regression, Logistic||Slope estimate is the monthly rate of change in CRPM up to week 12|To assess how nintedanib treatment affected the association between disease progression (as defined by absolute forced vital capacity (FVC) decline \>=10% or death) and the change in CRPM in the first 12 weeks, a logistic regression analysis including baseline blood CRPM, the monthly rate of change (slope) in blood CRPM up to Week 12, treatment and treatment-CRPM slope interaction as covariates was applied.||16.37|-109.55|0.1537
72381575|NCT02788474|144271654|OTHER||Odds Ratio (OR)|0.769||||0.3116|TWO_SIDED|95.0|0.46|1.27|||Regression, Logistic|||To assess whether the overall treatment regimen affected disease progression (as defined by absolute forced vital capacity (FVC) decline \>=10% or death), a logistic regression analysis including baseline blood CRPM and randomised treatment as covariates was applied.||1.27|0.46|0.3116
72381576|NCT02788474|144271654|OTHER||Odds Ratio (OR)|0.772||||0.3175|TWO_SIDED|95.0|0.46|1.27|||Regression, Logistic|||To assess whether the monthly rate of change (slope) in blood CRPM in the first 12 weeks could explain the effect of treatment on disease progression (as defined by absolute forced vital capacity (FVC) decline \>=10% or death), a logistic regression analysis including baseline blood CRPM, the rate of change (slope) in blood CRPM in the first 12 weeks and randomised treatment as covariates was applied.||1.27|0.46|0.3175
72381577|NCT02788474|144271655|OTHER||Adjusted mean difference|0.00121|STANDARD_ERROR_OF_MEAN|0.002||0.5469|TWO_SIDED|95.0|-0.00273|0.00515||random coefficient regression model (C1M (negative reciprocal root-transformed)) with fixed effects for gender, age, height and random effect of patient specific intercept and time.|random coefficient regression||Difference calculated as Nintedanib minus Placebo. Inter-individual variability is modelled by a Variance-Components variance-covariance matrix.|"The rate of change (slope) in blood C1M was assumed to be linear in each subject over the 12 weeks of treatment.~Within-patient errors are modelled by an Unstructured variance-covariance matrix."||0.00515|-0.00273|0.5469
72381578|NCT02788474|144271656|OTHER||Adjusted mean difference|-0.00307|STANDARD_ERROR_OF_MEAN|0.00262||0.2429|TWO_SIDED|95.0|-0.00823|0.00209||random coefficient regression model (C3M (log10-transformed)) with fixed effects for gender, age, height and random effect of patient specific intercept and time.|random coefficient regression||Difference calculated as Nintedanib minus Placebo. Inter-individual variability is modelled by a Variance-Components variance-covariance matrix.|"The rate of change (slope) in blood C3M was assumed to be linear in each subject over the 12 weeks of treatment.~Within-patient errors are modelled by an Unstructured variance-covariance matrix."||0.00209|-0.00823|0.2429
72381579|NCT01272284|144271657|SUPERIORITY_OR_OTHER_LEGACY||Proportion successful|85.4|||<|0.0001|ONE_SIDED|95.81|78.1||||Fisher Exact|||The final significance level is 0.04191 accounting for one interim analysis conducted at 80% of final information, thus a 95.81% Confidence Limit (CL) was used.|||78.1|<0.0001
72434131|NCT03593070|144381801|OTHER|Analyses compared changes in total scores for satisfaction with care measure (FPCT) from baseline to 24 weeks, for both arms of the intervention (CGMI-V and MT)|Slope|0.731|STANDARD_DEVIATION|0.074||0.001|TWO_SIDED|||||A priori alpha=0.05.|Regression, Linear|||||||0.001
72434132|NCT03593070|144381802|OTHER|Analyses compared changes in total Family Knowledge of Alzheimer's Test (FKAT) scores from baseline to 24 weeks, for both arms of the intervention (CGMI-V and MT)|Slope|0.687|STANDARD_DEVIATION|0.084||0.001|TWO_SIDED|||||A priori alpha=0.05.|Regression, Linear|||||||0.001
72434133|NCT03593070|144381803|OTHER||Slope|0.527|STANDARD_DEVIATION|0.088||0.001|TWO_SIDED|||||A prior alpha=0.05.|Regression, Linear|||Analyses compared changes in caregiver sense of loss, guilt, and role captivity scores from baseline to 24 weeks, for both arms of the intervention (CGMI-V and MT). This measure uses 51 items of the FPCR measure.||||0.001
72434134|NCT00816829|144381804|SUPERIORITY_OR_OTHER|||||||0.048||95.0|||||ANCOVA|||Comparison between groups was performed using an ANCOVA on log-transformed data at one month after the start of the treatment.||||0.048
72434135|NCT00816829|144381805|SUPERIORITY_OR_OTHER|||||||0.203||95.0|||||ANCOVA|||Comparison between groups was performed using an ANCOVA on log-transformed data at one month after the start of the treatment.||||0.203
72434136|NCT00816829|144381806|SUPERIORITY_OR_OTHER|||||||0.007||95.0|||||Wilcoxon (Mann-Whitney)|||Comparison between groups was performed using Wilcoxon Test on data at one month after the start of the treatment.||||0.007
72434137|NCT00816829|144381807|SUPERIORITY_OR_OTHER|||||||0.199||95.0|||||ANCOVA|||Comparison between groups was performed using an ANCOVA on log-transformed data at one month after the start of the treatment.||||0.199
72434138|NCT00816829|144381808|SUPERIORITY_OR_OTHER|||||||0.114||95.0|||||ANCOVA|||Comparison between groups was performed using an ANCOVA on log-transformed data at one month after the start of the treatment.||||0.114
72434139|NCT00816829|144381809|SUPERIORITY_OR_OTHER|||||||0.533||95.0|||||ANCOVA|||Comparison between groups was performed using an ANCOVA on log-transformed data at one month after the start of the treatment.||||0.533
72434140|NCT00816829|144381810|SUPERIORITY_OR_OTHER|||||||0.521||95.0|||||ANCOVA|||Comparison between groups was performed using an ANCOVA on log-transformed data at one month after the start of the treatment.||||0.521
72381580|NCT00048061|144271670|NON_INFERIORITY_OR_EQUIVALENCE|The monthly dosing regimen (Ibandronate 50/50 mg monthly) was considered non-inferior to the 2.5 mg daily regimen if the lower bound of the two-sided 95% CI on the difference in mean percent change in BMD was greater or equal to -1 percentage point.|Mean Difference (Final Values)|0.615||||0.045|TWO_SIDED|95.0|0.013|1.216|||ANOVA||Treatment effect is the difference in the mean values of the monthly oral dose regimens (Ibandronate 50/50) and the active-control.|||1.216|0.013|0.045
72434141|NCT00816829|144381811|SUPERIORITY_OR_OTHER|||||||0.333||95.0|||||ANCOVA|||Comparison between groups was performed using an ANCOVA on log-transformed data at one month after the start of the treatment.||||0.333
72434142|NCT00816829|144381812|SUPERIORITY_OR_OTHER|||||||0.264||95.0|||||ANCOVA|||Comparison between groups was performed using an ANCOVA on log-transformed data at one month after the start of the treatment.||||0.264
72434143|NCT00816829|144381813|SUPERIORITY_OR_OTHER|||||||0.401||95.0|||||ANCOVA|||Comparison between groups was performed using an ANCOVA on log-transformed data at one month after the start of the treatment.||||0.401
72434144|NCT02197234|144381822|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|90% CIs being within 70% to 143%.|Geometric mean ratio|77.08|||||TWO_SIDED|90.0|63.41|93.7|||||Simvastatin + AZD9291 / Simvastatin alone. Based on linear mixed-effects model with treatment as fixed effect and patient as a random effect.|Study sized so experiment-wise power for the 90% CIs of geometric mean ratios for both AUC and Cmax of AUC9291 being within 70-143% was 90% (95% for each parameter). Within patient CV assumed to be 45%. No change in exposure was also assumed.||93.70|63.41|
72434145|NCT02197234|144381823|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|90% CIs being within 70% to 143%.|Geometric mean ratio|91.46|||||TWO_SIDED|90.0|77.16|108.41|||||Simvastatin + AZD9291 / Simvastatin alone. Based on linear mixed-effects model with treatment as fixed effect and patient as a random effect.|Study sized so experiment-wise power for the 90% CIs of geometric mean ratios for both AUC and Cmax of AUC9291 being within 70-143% was 90% (95% for each parameter). Within patient CV assumed to be 45%. No change in exposure was also assumed.||108.41|77.16|
72469435|NCT04750577|144462631|OTHER|MMRM estimates were used as input for the MCP-Mod. including the fixed, categorical effects of treatment at each visit (baseline, Week 6, Week 12 and Week 20), and the continuous effect of baseline at each visit as well as random effects of patient.||||||0.0245|||||||MCP-Mod exponential model fit|Model assumption: 20% of the maximum effect is achieved at 3 mg.||A flat vs. non-flat dose-response relationship across the 3 doses of BI 685509 and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, exponential, quadratic, Emax and Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.050). The total daily dose was considered for MCP-Mod analysis (placebo, active BI 685509 3 mg, 6 mg, and 9 mg).||||0.0245
72493957|NCT00493038|144516814|NON_INFERIORITY_OR_EQUIVALENCE|"The non-inferiority margin was set to 15% in the protocol. Sample size was estimated using the method as described in Farrington-Manning (STATISTICS IN MEDICINE, Vol. 9; Farrington CP, Manning G: Test statistics and sample size formulae for comparative binomial trials with null hypothesis of non-zero risk difference..., pg.1447-1454 \[1990\]). Estimation was performed to achieve 90% power, based on the equivalence delta of 15%, and a clinical success rate of 80% in the per protocol population."|Mean Difference (Final Values)|-0.5||||||95.0|-7.9|6.8||||||Calculated were 95% confidence intervals for the difference in success rates between treatment groups (moxifloxacin minus comparator). Method as described in Koch et al. ('Categorical Data Analysis' in Statistical methodology in the pharmaceutical sciences / edited by D. A. Berry, p. 415 ff., Marcel Dekker, 1990)||6.8|-7.9|
72381581|NCT00048061|144271670|NON_INFERIORITY_OR_EQUIVALENCE|The monthly dosing regimen (Ibandronate 100 mg) was considered non-inferior to the 2.5 mg daily regimen if the lower bound of the two-sided 95% CI on the difference in mean percent change in BMD was greater or equal to -1 percentage point.|Mean Difference (Final Values)|0.297||||0.338|TWO_SIDED|95.0|-0.312|0.906|||ANOVA||Treatment effect is the difference in the mean values of the monthly oral dose regimens (Ibandronate 100 mg) and the active-control|||0.906|-0.312|0.338
72381582|NCT00048061|144271670|NON_INFERIORITY_OR_EQUIVALENCE|The monthly dosing regimen (Ibandronate 150 mg) was considered non-inferior to the 2.5 mg daily regimen if the lower bound of the two-sided 95% CI on the difference in mean percent change in BMD was greater or equal to -1 percentage point.|Mean Difference (Final Values)|1.0||||0.001|TWO_SIDED|95.0|0.395|1.605|||ANOVA||Treatment effect is the difference in the mean values of the monthly oral dose regimens (Ibandronate 150 mg) and the active-control.|||1.605|0.395|0.001
72381583|NCT00573248|144271723|SUPERIORITY_OR_OTHER||||||<|0.025|ONE_SIDED|||||Adjusted for multiple comparisons|ANOVA|||2 (nicotine versus placebo) x 2 (smokers versus nonsmokers) ANOVA for each diary item||||<0.025
72381584|NCT00573248|144271724|SUPERIORITY_OR_OTHER||||||<|0.025|ONE_SIDED||||||ANOVA|||2 (nicotine versus placebo) x 2 (smoker versus nonsmoker) ANOVA||||<0.025
72381585|NCT00573248|144271725|SUPERIORITY_OR_OTHER||||||<|0.025|ONE_SIDED|||||Adjusted for multiple comparisons|ANOVA|||2 (nicotine versus placebo) x 2 (smokers versus nonsmokers) ANOVA for each diary item||||<0.025
72381586|NCT00573248|144271726|SUPERIORITY_OR_OTHER||||||<|0.025|ONE_SIDED|||||Adjusted for multiple comparisons|ANOVA|||2 (nicotine versus placebo) x 2 (smokers versus nonsmokers) ANOVA for each diary item||||<0.025
72381587|NCT02017171|144271727|SUPERIORITY||Mean Difference (Final Values)|0.001||||0.999|TWO_SIDED|95.0|-1.9|1.9||p value is not adjusted for multiple comparisons, a priori threshold for statistical significance: p\<0.05|linear model for correlated errors||Treatment difference = Allopurinol-Placebo|||1.9|-1.9|0.999
72381588|NCT02017171|144271728|SUPERIORITY||Mean Difference (Final Values)|0.3|||||TWO_SIDED|95.0|-1.6|2.2||For secondary outcomes, 95% confidence intervals are reported, without P values. The confidence intervals are not adjusted for multiplicity and should not be used to infer treatment effects.|||Treatment difference = Allopurinol - Placebo|||2.2|-1.6|
72381589|NCT02017171|144271729|SUPERIORITY||Mean Difference (Final Values)|0.3|||||TWO_SIDED|95.0|-1.7|2.3||For secondary outcomes, 95% confidence intervals are reported, without P values. The confidence intervals are not adjusted for multiplicity and should not be used to infer treatment effects.|||Treatment difference = Allopurinol - Placebo|||2.3|-1.7|
72381590|NCT02017171|144271730|SUPERIORITY||Mean Difference (Final Values)|-0.6|||||TWO_SIDED|95.0|-1.5|0.4||For secondary outcomes, 95% confidence intervals are reported, without P values.|||Treatment difference = Allopurinol - Placebo. Confidence intervals are not adjusted for multiplicity and should not be used to infer treatment effects.|||0.4|-1.5|
72381591|NCT02017171|144271731|SUPERIORITY||Mean Difference (Final Values)|-0.3|||||TWO_SIDED|95.0|-1.0|0.5||For secondary outcomes, 95% confidence intervals are reported, without P values.|||Treatment difference = Allopurinol - Placebo. Confidence intervals are not adjusted for multiplicity and should not be used to infer treatment effects.|||0.5|-1.0|
72381592|NCT02017171|144271732|SUPERIORITY||Hazard Ratio (HR)|1.2|||||TWO_SIDED|95.0|0.5|2.9||For secondary outcomes, 95% confidence intervals are reported, without P values.|||Hazard ratio = Allopurinol / Placebo. Confidence intervals are not adjusted for multiplicity and should not be used to infer treatment effects.|||2.9|0.5|
72381593|NCT02017171|144271733|SUPERIORITY||Ratio (Final Values)|1.4|||||TWO_SIDED|95.0|1.0|1.8||For secondary outcomes, 95% confidence intervals are reported, without P values.|||Ratio = Allopurinol / Placebo. Confidence intervals are not adjusted for multiplicity and should not be used to infer treatment effects.|||1.8|1.0|
72381594|NCT02017171|144271734|SUPERIORITY||Ratio (Final Values)|1.3|||||TWO_SIDED|95.0|1.0|1.6||For secondary outcomes, 95% confidence intervals are reported, without P values.|||||Ratio = Allopurinol / Placebo. Confidence intervals are not adjusted for multiplicity and should not be used to infer treatment effects.|1.6|1.0|
72381595|NCT02017171|144271735|SUPERIORITY||Hazard Ratio (HR)|1.9|||||TWO_SIDED|95.0|0.8|4.5||For secondary outcomes, 95% confidence intervals are reported, without P values.|||Hazard Ratio = Allopurinol / Placebo. Confidence intervals are not adjusted for multiplicity and should not be used to infer treatment effects.|||4.5|0.8|
72381596|NCT02220998|144271750|NON_INFERIORITY_OR_EQUIVALENCE|A sample size of 120 per treatment group provided 90% power to establish non-inferiority in the SVR12 rates between the SOF/VEL group and the SOF+RBV group. It was based on the assumptions that the non-inferiority margin is 10%, both groups have a SVR12 rate of 94%, and the significance level is 0.025 one-sided.|Difference in proportions|5.2|||||TWO_SIDED|95.0|0.2|10.3|||||Difference in proportions between treatment groups and associated 95% confidence intervals (CI) are calculated based on stratum-adjusted Mantel-Haenszel proportions.|||10.3|0.2|
72381597|NCT02220998|144271750|SUPERIORITY_OR_OTHER|||||||0.018||||||P-value was stratified by cirrhosis status and prior treatment experience.|Cochran-Mantel-Haenszel|||The superiority of SOF/VEL for 12 weeks over SOF+RBV for 12 weeks was to be tested if the efficacy of SOF/VEL for 12 weeks was demonstrated to be statistically noninferior to SOF+RBV for 12 weeks (ie, if the lower bound of the 95% CI for the strata-adjusted difference in the proportions between groups was greater than the prespecified noninferiority margin of -10%).||||0.018
72381598|NCT02314143|144271758|OTHER||Odds Ratio (OR)|1.0||||1|TWO_SIDED|95.0|0.224|4.459|||Cochran-Mantel-Haenszel||The odds ratio for dabrafenib followed by combination therapy versus combination therapy has been presented.|||4.459|0.224|1.0000
72381599|NCT02314143|144271758|OTHER||Odds Ratio (OR)|1.97||||0.4216|TWO_SIDED|95.0|0.382|10.166|||Cochran-Mantel-Haenszel||The odds ratio for trametinib followed by combination therapy versus combination therapy has been presented.|||10.166|0.382|0.4216
72381600|NCT00873860|144271770|SUPERIORITY_OR_OTHER|||||||0.573||||||Change at Day 92: p-value was based on analysis of variance (ANOVA).|ANOVA|||||||0.573
72381601|NCT00873860|144271770|SUPERIORITY_OR_OTHER|||||||0.64||||||Change at Day 92: p-value was based on ANOVA.|ANOVA|||||||0.640
72381602|NCT00873860|144271770|SUPERIORITY_OR_OTHER|||||||0.224||||||Change at Day 92: p-value was based on ANOVA.|ANOVA|||||||0.224
72381603|NCT00873860|144271771|SUPERIORITY_OR_OTHER|||||||0.4686||||||Day 1 to 92: P-value was calculated against placebo group from a stratified log-rank test with atopic asthma status and tertile of baseline mean ACQ score as the stratification factors.|Log Rank|||P-value were calculated with log-rank test, which was constructed by computing the observed and expected number of events (defined as achieving improvement from baseline in mean ACQ-6 score \>= 0.5) at each observed event time and added to obtain an overall summary across all-time points where there was an event. Number of events was different for data through Day 92 comparing with data through Day 169. Therefore, the p-values were different for data through Day 92 and Day 169.||||0.4686
72381604|NCT00873860|144271771|SUPERIORITY_OR_OTHER|||||||0.317||||||Day 1 to 92: P-value was calculated against placebo group from a stratified log-rank test with atopic asthma status and tertile of baseline mean ACQ score as the stratification factors.|Log Rank|||P-value were calculated with log-rank test, which was constructed by computing the observed and expected number of events (defined as achieving improvement from baseline in mean ACQ-6 score \>= 0.5) at each observed event time and added to obtain an overall summary across all-time points where there was an event. Number of events was different for data through Day 92 comparing with data through Day 169. Therefore, the p-values were different for data through Day 92 and Day 169.||||0.3170
72381605|NCT00873860|144271771|SUPERIORITY_OR_OTHER|||||||0.1664||||||Day 1 to 92: P-value was calculated against placebo group from a stratified log-rank test with atopic asthma status and tertile of baseline mean ACQ score as the stratification factors.|Log Rank|||P-value were calculated with log-rank test, which was constructed by computing the observed and expected number of events (defined as achieving improvement from baseline in mean ACQ-6 score \>= 0.5) at each observed event time and added to obtain an overall summary across all-time points where there was an event. Number of events was different for data through Day 92 comparing with data through Day 169. Therefore, the p-values were different for data through Day 92 and Day 169.||||0.1664
72381606|NCT00873860|144271771|SUPERIORITY_OR_OTHER|||||||0.3234||||||Day 1 to 169: P-value was calculated against placebo group from a stratified log-rank test with atopic asthma status and tertile of baseline mean ACQ score as the stratification factors.|Log Rank|||P-value were calculated with log-rank test, which was constructed by computing the observed and expected number of events (defined as achieving improvement from baseline in mean ACQ-6 score \>= 0.5) at each observed event time and added to obtain an overall summary across all-time points where there was an event. Number of events was different for data through Day 92 comparing with data through Day 169. Therefore, the p-values were different for data through Day 92 and Day 169.||||0.3234
72381607|NCT00873860|144271771|SUPERIORITY_OR_OTHER|||||||0.3133||||||Day 1 to 169: P-value was calculated against placebo group from a stratified log-rank test with atopic asthma status and tertile of baseline mean ACQ score as the stratification factors.|Log Rank|||P-value were calculated with log-rank test, which was constructed by computing the observed and expected number of events (defined as achieving improvement from baseline in mean ACQ-6 score \>= 0.5) at each observed event time and added to obtain an overall summary across all-time points where there was an event. Number of events was different for data through Day 92 comparing with data through Day 169. Therefore, the p-values were different for data through Day 92 and Day 169.||||0.3133
72434146|NCT01018511|144381831|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Overall power was 90% power for non-inferiority vs placebo for total IPSS. Only the FDC(s) that succeeded in stage 1 were evaluated in stage 2 for total IPSS. If both FDCs succeeded in stage 1, then both FDCs proceeded to stage 2 and the Hochberg procedure was implemented at one-sided alpha = 0.025. If one FDC succeeded in stage 1, then only this FDC proceeded to stage 2 and the FDC vs. TOCAS alone for non-inferiority was assessed at one-sided alpha = 0.025/2 = 0.0125.|Least Squares Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.41||0.001|TWO_SIDED|97.5|-1.73|0.11||The primary analysis was adjusted for multiplicity for IPSS using the Hochberg procedure involving 2 stages: Stage 1, superiority to placebo and Stage 2: non-inferiority to tamsulosin alone, with a switch to superiority where applicable.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||The non-inferiority of FDC vs TOCAS on the change from baseline to end of treatment in total IPSS. A FDC was regarded successful if it showed superiority vs. placebo for total IPSS, noninferiority vs. TOCAS alone for total IPSS along with superiority vs. TOCAS alone for TUS.||0.11|-1.73|0.001
72434147|NCT01018511|144381831|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Only the FDC(s) that succeeded in stage 1 were evaluated in stage 2 for total IPSS. If both FDCs succeeded in stage 1, then both FDCs proceeded to stage 2 and the Hochberg procedure was implemented at one-sided alpha = 0.025. If one FDC succeeded in stage 1, then only this FDC proceeded to stage 2 and the FDC vs. TOCAS alone for non-inferiority was assessed at one-sided alpha = 0.025/2 = 0.0125.|Least Squares Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.41||0.028|TWO_SIDED|97.5|-1.22|0.64||The primary analysis was adjusted for multiplicity for IPSS using the Hochberg procedure involving 2 stages: Stage 1, superiority to placebo and Stage 2: non-inferiority to tamsulosin alone, with a switch to superiority where applicable.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||The non-inferiority of FDC vs. TOCAS on the change from baseline to end of treatment in total IPSS. A FDC was regarded successful if it showed superiority vs. placebo for total IPSS, noninferiority vs. TOCAS alone for total IPSS along with superiority vs. TOCAS alone for TUS.||0.64|-1.22|0.028
72434148|NCT01018511|144381831|SUPERIORITY_OR_OTHER_LEGACY|||||||0.048|TWO_SIDED|||||The primary analysis was adjusted for multiplicity for IPSS using the Hochberg procedure involving 2 stages: Stage 1, superiority to placebo and Stage 2: non-inferiority to tamsulosin alone, with a switch to superiority where applicable.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||The superiority of FDC vs. TOCAS on the change from baseline to end of treatment in total IPSS.||||0.048
72556644|NCT02635750|144644473|OTHER||Adjusted gMean ratio(%)|113.08|||||TWO_SIDED|90.0|106.41|120.15|||||Ratio of donepezil 5mg with BI 409306 100mg and donepezil 5mg alone. (BI 409306+don / don) Intra-individual coefficient of variation (gCV (%)) = 9.0.|"The PK endpoints were log transformed (natural logarithm) prior to fitting the ANOVA model. This model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'periods' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.~Abbreviations used: geometric mean (gMean), donepezil (don)"||120.15|106.41|
72556645|NCT02635750|144644474|OTHER||Adjusted gMean ratio(%)|100.01|||||TWO_SIDED|90.0|89.549|111.68|||||Ratio of BI 409306 25mg with donepezil 10mg and BI 409306 25mg alone (BI 409306+don/ BI 409306). Intra-individual coefficient of variation (gCV(%)) = 18.6.|The statistical model used for the analysis of those endpoints was an analysis of variance (ANOVA) model on the logarithmic scale (natural logarithm). This model included effects accounting for the following sources of variation: 'subjects' and 'treatment'. The effect 'subjects' was considered as random, whereas the other effect was considered as fixed. Abbreviations used: geometric mean (gMean), donepezil (don)||111.68|89.549|
72556646|NCT02635750|144644475|OTHER||Adjusted gMean ratio(%)|98.38|||||TWO_SIDED|90.0|93.413|103.6|||||Ratio of donepezil 5mg with BI 409306 100mg and donepezil 5mg alone (BI 409306+don / don). Intra-individual coefficient of variation (gCV (%)) = 7.7.|"The PK endpoints were log transformed (natural logarithm) prior to fitting the ANOVA model. This model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'periods' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.~Abbreviations used: geometric mean (gMean), donepezil (don)"||103.60|93.413|
72556647|NCT00835705|144644492|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of Least Squares Means|103.03||||||90.0|98.4|107.88|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||107.88|98.40|
72381608|NCT00873860|144271771|SUPERIORITY_OR_OTHER|||||||0.2108||||||Day 1 to 169: P-value was calculated against placebo group from a stratified log-rank test with atopic asthma status and tertile of baseline mean ACQ score as the stratification factors.|Log Rank|||P-value were calculated with log-rank test, which was constructed by computing the observed and expected number of events (defined as achieving improvement from baseline in mean ACQ-6 score \>= 0.5) at each observed event time and added to obtain an overall summary across all-time points where there was an event. Number of events was different for data through Day 92 comparing with data through Day 169. Therefore, the p-values were different for data through Day 92 and Day 169.||||0.2108
72381609|NCT00873860|144271778|SUPERIORITY_OR_OTHER|||||||0.934||||||ACQ score \<=0.75, Day 92: Fisher exact test was used to compare all arms.|Fisher Exact|||||||0.934
72381610|NCT00873860|144271778|SUPERIORITY_OR_OTHER|||||||0.592||||||ACQ score \<=0.75, Day 169: Fisher exact test was used to compare all arms.|Fisher Exact|||||||0.592
72556648|NCT00835705|144644493|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of Least Squares Means|98.43||||||90.0|96.71|100.18|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||100.18|96.71|
72556649|NCT00835705|144644494|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of Least Squares Means|98.29||||||90.0|96.58|100.03|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||100.03|96.58|
72381611|NCT00873860|144271783|SUPERIORITY_OR_OTHER|||||||1||||||Day 92: Fisher exact test was used for the analysis.|Fisher Exact|||||||1.0000
72381612|NCT00873860|144271783|SUPERIORITY_OR_OTHER|||||||0.6022||||||Day 92: Fisher exact test was used for the analysis.|Fisher Exact|||||||0.6022
72381613|NCT00873860|144271783|SUPERIORITY_OR_OTHER|||||||1||||||Day 92: Fisher exact test was used for the analysis.|Fisher Exact|||||||1.0000
72381614|NCT00873860|144271783|SUPERIORITY_OR_OTHER|||||||1||||||Day 169: Fisher exact test was used for the analysis.|Fisher Exact|||||||1.0000
72434149|NCT01018511|144381831|SUPERIORITY_OR_OTHER_LEGACY|||||||0.483|TWO_SIDED|||||The primary analysis was adjusted for multiplicity for IPSS using the Hochberg procedure involving 2 stages: Stage 1, superiority to placebo and Stage 2: non-inferiority to tamsulosin alone, with a switch to superiority where applicable.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||The superiority of FDC vs. TOCAS on the change from baseline to end of treatment in total IPSS.||||0.483
72434150|NCT01018511|144381831|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-1.6|STANDARD_ERROR_OF_MEAN|0.4|<|0.001|TWO_SIDED|95.0|-2.4|-0.9||The primary analysis was adjusted for multiplicity for IPSS using the Hochberg procedure involving 2 stages: Stage 1, superiority to placebo and Stage 2: non-inferiority to tamsulosin alone, with a switch to superiority where applicable.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||The superiority of the FDC vs placebo on the change from baseline to end of treatment in total IPSS. A FDC was regarded successful if it showed superiority vs. placebo for total IPSS, noninferiority vs. TOCAS alone for total IPSS along with superiority vs. TOCAS alone for TUS.||-0.9|-2.4|<0.001
72434151|NCT01018511|144381831|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|0.41||0.006|TWO_SIDED|95.0|-1.9|-0.3||The primary analysis was adjusted for multiplicity for IPSS using the Hochberg procedure involving 2 stages: Stage 1, superiority to placebo and Stage 2: non-inferiority to tamsulosin alone, with a switch to superiority where applicable.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||The superiority of the FDC vs. placebo on the change from baseline to end of treatment in total IPSS. A FDC was regarded successful if it showed superiority vs. placebo for total IPSS, noninferiority vs. TOCAS alone for total IPSS along with superiority vs. TOCAS alone for TUS.||-0.3|-1.9|0.006
72434152|NCT01018511|144381831|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.41||0.039|TWO_SIDED|95.0|-1.6|0.0||No adjustments for multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||The superiority of TOCAS vs. placebo on the change from baseline to end of treatment in total IPSS. With a sample size of 274 participants per arm, the overall power to meet this outcome measure was 97% power for superiority vs placebo for total IPSS.||-0.0|-1.6|0.039
72434153|NCT01018511|144381832|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-1.4|STANDARD_ERROR_OF_MEAN|0.64||0.025|TWO_SIDED|97.5|-2.9|0.0||The primary analysis was adjusted for multiplicity for TUS using the Hochberg procedure.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||The superiority of FDC 0.4 mg/6 mg vs. TOCAS in the change from baseline to end of treatment in TUS. A FDC was regarded successful if it showed superiority vs. placebo for total IPSS, noninferiority vs. TOCAS alone for total IPSS along with superiority vs. TOCAS alone for TUS.||0.0|-2.9|0.025
72556650|NCT00835705|144644495|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of Least Squares Means|103.16||||||90.0|95.33|111.64|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||111.64|95.33|
72381615|NCT00873860|144271783|SUPERIORITY_OR_OTHER|||||||1||||||Day 169: Fisher exact test was used for the analysis.|Fisher Exact|||||||1.0000
72434154|NCT01018511|144381832|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.9|STANDARD_ERROR_OF_MEAN|0.64||0.162|TWO_SIDED|97.5|-2.3|0.5||The primary analysis was adjusted for multiplicity for TUS using the Hochberg procedure.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||The superiority of FDC 0.4 mg/6 mg vs. TOCAS in the change from baseline to end of treatment in TUS. A FDC was regarded successful if it showed superiority vs. placebo for total IPSS, noninferiority vs. TOCAS alone for total IPSS along with superiority vs. TOCAS alone for TUS.||0.5|-2.3|0.162
72434155|NCT01018511|144381832|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-3.7|STANDARD_ERROR_OF_MEAN|0.62|<|0.001|TWO_SIDED|95.0|-4.9|-2.5||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||The superiority of FDC 0.4 mg/6 mg vs. placebo on the change from baseline to end of treatment in TUS.||-2.5|-4.9|<0.001
72556651|NCT00835705|144644496|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of Least Squares Means|103.79||||||90.0|95.75|112.5|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||112.50|95.75|
72381616|NCT00873860|144271783|SUPERIORITY_OR_OTHER|||||||1||||||Day 169: Fisher exact test was used for the analysis.|Fisher Exact|||||||1.0000
72381617|NCT00873860|144271784|SUPERIORITY_OR_OTHER|||||||0.551||||||Day 1 to 92: P-value was calculated against placebo group from Van Elteren Test.|Van Elteren Test|||||||0.551
72381618|NCT00873860|144271784|SUPERIORITY_OR_OTHER|||||||0.492||||||Day 1 to 92: P-value was calculated against placebo group from Van Elteren Test.|Van Elteren Test|||||||0.492
72381619|NCT00873860|144271784|SUPERIORITY_OR_OTHER|||||||0.983||||||Day 1 to 92: P-value was calculated against placebo group from Van Elteren Test.|Van Elteren Test|||||||0.983
72381620|NCT00873860|144271784|SUPERIORITY_OR_OTHER|||||||0.991||||||Day 1 to 169: P-value was calculated against placebo group from Van Elteren Test.|Van Elteren Test|||||||0.991
72381621|NCT00873860|144271784|SUPERIORITY_OR_OTHER|||||||0.9||||||Day 1 to 169: P-value was calculated against placebo group from Van Elteren Test.|Van Elteren Test|||||||0.900
72556652|NCT00835705|144644497|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of Least Squares Means|104.26||||||90.0|95.76|113.52|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||113.52|95.76|
72556653|NCT01750294|144644498|SUPERIORITY_OR_OTHER|||||||0.01||||||a = 0.05|Mixed Models Analysis|||||||0.01
72556654|NCT01592240|144644580|SUPERIORITY_OR_OTHER||Adjusted mean difference|-34.28|||<|0.001|TWO_SIDED|95.0|-45.06|-23.5|||Mixed models repeated measures analysis|||||-23.50|-45.06|<0.001
72556655|NCT01592240|144644580|SUPERIORITY_OR_OTHER||Adjusted mean difference|-45.07|||<|0.001|TWO_SIDED|95.0|-55.93|-34.21|||Mixed models repeated measures analysis|||||-34.21|-55.93|<0.001
72556656|NCT01592240|144644580|SUPERIORITY_OR_OTHER||Adjusted mean difference|-53.42|||<|0.001|TWO_SIDED|95.0|-64.14|-42.7|||Mixed models repeated measures analysis|||||-42.70|-64.14|<0.001
72556657|NCT01592240|144644580|SUPERIORITY_OR_OTHER||Adjusted mean difference|-27.58|||<|0.001|TWO_SIDED|95.0|-40.49|-14.67|||Mixed models repeated measures analysis|||||-14.67|-40.49|<0.001
72381622|NCT00873860|144271784|SUPERIORITY_OR_OTHER|||||||0.673||||||Day 1 to 169: P-value was calculated against placebo group from Van Elteren Test.|Van Elteren Test|||||||0.673
72381623|NCT00873860|144271785|SUPERIORITY_OR_OTHER|||||||0.546||||||Day 1 to 92: P-value was calculated against placebo group from a stratified log-rank test with atopic asthma status and tertile of baseline mean ACQ score as the stratification factors.|Log Rank|||||||0.546
72381624|NCT00873860|144271785|SUPERIORITY_OR_OTHER|||||||0.534||||||Day 1 to 92: P-value was calculated against placebo group from a stratified log-rank test with atopic asthma status and tertile of baseline mean ACQ score as the stratification factors.|Log Rank|||||||0.534
72381625|NCT00873860|144271785|SUPERIORITY_OR_OTHER|||||||0.847||||||Day 1 to 92: P-value was calculated against placebo group from a stratified log-rank test with atopic asthma status and tertile of baseline mean ACQ score as the stratification factors.|Log Rank|||||||0.847
72381626|NCT00873860|144271785|SUPERIORITY_OR_OTHER|||||||0.987||||||Day 1 to 169: P-value was calculated against placebo group from a stratified log-rank test with atopic asthma status and tertile of baseline mean ACQ score as the stratification factors.|Log Rank|||||||0.987
72381627|NCT00873860|144271785|SUPERIORITY_OR_OTHER|||||||0.992||||||Day 1 to 169: P-value was calculated against placebo group from a stratified log-rank test with atopic asthma status and tertile of baseline mean ACQ score as the stratification factors.|Log Rank|||||||0.992
72434156|NCT01018511|144381832|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-3.2|STANDARD_ERROR_OF_MEAN|0.63|<|0.001|TWO_SIDED|95.0|-4.4|-1.9||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||The superiority of FDC 0.4 mg/9 mg vs. placebo on the change from baseline to end of treatment in TUS.||-1.9|-4.4|<0.001
72434157|NCT01018511|144381832|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-2.3|STANDARD_ERROR_OF_MEAN|0.64|<|0.001|TWO_SIDED|95.0|-3.5|-1.0||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||The superiority of TOCAS vs. placebo on the change from baseline to end of treatment in TUS.||-1.0|-3.5|<0.001
72434158|NCT01018511|144381833|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.17|<|0.001|TWO_SIDED|95.0|-1.0|-0.3||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs TOCAS.||-0.3|-1.0|<0.001
72556658|NCT01592240|144644580|SUPERIORITY_OR_OTHER||Adjusted mean difference|-44.85|||<|0.001|TWO_SIDED|95.0|-57.65|-32.05|||Mixed models repeated measures analysis|||||-32.05|-57.65|<0.001
72556659|NCT01592240|144644581|SUPERIORITY_OR_OTHER||Adjusted mean difference|-28.41|||<|0.001|TWO_SIDED|95.0|-39.15|-17.67|||Mixed models repeated measures analysis|||||-17.67|-39.15|<0.001
72381628|NCT00873860|144271785|SUPERIORITY_OR_OTHER|||||||0.688||||||Day 1 to 169: P-value was calculated against placebo group from a stratified log-rank test with atopic asthma status and tertile of baseline mean ACQ score as the stratification factors.|Log Rank|||||||0.688
72381629|NCT00708071|144271786|SUPERIORITY_OR_OTHER||Difference in Proportions|0.25||||0.143||95.0|-0.04|0.49|||McNemar||Difference in Proportions = SoC - FS VH S/D 4|||0.49|-0.04|0.143
72556660|NCT01592240|144644581|SUPERIORITY_OR_OTHER||Adjusted mean difference|-43.21|||<|0.001|TWO_SIDED|95.0|-53.9|-32.51|||Mixed models repeated measures analysis|||||-32.51|-53.90|<0.001
72381630|NCT00708071|144271787|SUPERIORITY_OR_OTHER||Difference in proportions|0.31|||||TWO_SIDED|90.0|0.12|0.48|||||Difference in proportions = SoC - FS VH S/D 4|||0.48|0.12|
72556661|NCT01592240|144644581|SUPERIORITY_OR_OTHER||Adjusted mean difference|-41.03|||<|0.001|TWO_SIDED|95.0|-51.66|-30.41|||Mixed models repeated measures analysis|||||-30.41|-51.66|<0.001
72556662|NCT01592240|144644581|SUPERIORITY_OR_OTHER||Adjusted mean difference|-23.77|||<|0.001|TWO_SIDED|95.0|-33.7|-13.84|||Mixed models repeated measures analysis|||||-13.84|-33.70|<0.001
72556663|NCT01592240|144644581|SUPERIORITY_OR_OTHER||Adjusted mean difference|-30.36|||<|0.001|TWO_SIDED|95.0|-40.24|-20.49|||Mixed models repeated measures analysis|||||-20.49|-40.24|<0.001
72381631|NCT00708071|144271788|SUPERIORITY_OR_OTHER||Difference in proportions|0.111|||||TWO_SIDED|90.0|-0.11|0.32|||||Difference in proportions = SoC - FS VH S/D 4|||0.32|-0.11|
72381632|NCT00708071|144271789|SUPERIORITY_OR_OTHER||Difference in proportions|-0.032|||||TWO_SIDED|90.0|-0.24|0.18|||||Difference in proportions = SoC - FS VH S/D 4|||0.18|-0.24|
72381633|NCT00708071|144271790|SUPERIORITY_OR_OTHER||Difference in proportions|0.0|||||TWO_SIDED|90.0|-0.21|0.21|||||Difference in proportions = SoC - FS VH S/D 4|||0.21|-0.21|
72556664|NCT01592240|144644582|SUPERIORITY_OR_OTHER||Adjusted mean difference|-35.0|||<|0.001|TWO_SIDED|95.0|-44.91|-25.1|||Mixed models repeated measures analysis|||Week 12||-25.10|-44.91|<0.001
72556665|NCT01592240|144644582|SUPERIORITY_OR_OTHER||Adjusted mean difference|-42.32|||<|0.001|TWO_SIDED|95.0|-52.3|-32.33|||Mixed models repeated measures analysis|||Week 12||-32.33|-52.30|<0.001
72556666|NCT01592240|144644582|SUPERIORITY_OR_OTHER||Adjusted mean difference|-53.12|||<|0.001|TWO_SIDED|95.0|-62.97|-43.27|||Mixed models repeated measures analysis|||Week 12||-43.27|-62.97|<0.001
72556667|NCT01592240|144644582|SUPERIORITY_OR_OTHER||Adjusted mean difference|-26.96|||<|0.001|TWO_SIDED|95.0|-38.25|-15.67|||Mixed models repeated measures analysis|||Week 12||-15.67|-38.25|<0.001
72556668|NCT01592240|144644582|SUPERIORITY_OR_OTHER||Adjusted mean difference|-41.13|||<|0.001|TWO_SIDED|95.0|-52.32|-29.94|||Mixed models repeated measures analysis|||Week 12||-29.94|-52.32|<0.001
72556669|NCT01592240|144644582|SUPERIORITY_OR_OTHER||Adjusted mean difference|-29.09|||<|0.001|TWO_SIDED|95.0|-38.42|-19.77|||Mixed models repeated measures analysis|||Week 24||-19.77|-38.42|<0.001
72556670|NCT01592240|144644582|SUPERIORITY_OR_OTHER||Adjusted mean difference|-40.14|||<|0.001|TWO_SIDED|95.0|-49.43|-30.86|||Mixed models repeated measures analysis|||Week 24||-30.86|-49.43|<0.001
72556671|NCT01592240|144644582|SUPERIORITY_OR_OTHER||Adjusted mean difference|-39.16|||<|0.001|TWO_SIDED|95.0|-48.37|-29.94|||Mixed models repeated measures analysis|||Week 24||-29.94|-48.37|<0.001
72556672|NCT01592240|144644582|SUPERIORITY_OR_OTHER||Adjusted mean difference|-23.79|||<|0.001|TWO_SIDED|95.0|-32.88|-14.7|||Mixed models repeated measures analysis|||Week 24||-14.70|-32.88|<0.001
72556673|NCT01592240|144644582|SUPERIORITY_OR_OTHER||Adjusted mean difference|-29.08|||<|0.001|TWO_SIDED|95.0|-38.13|-20.04|||Mixed models repeated measures analysis|||Week 24||-20.04|-38.13|<0.001
72556674|NCT01592240|144644583|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|1.64||||0.281|TWO_SIDED|95.0|-1.35|4.63|||Mixed models repeated measures analysis|||Week 12||4.63|-1.35|0.281
72556675|NCT01592240|144644583|SUPERIORITY_OR_OTHER||Adjusted mean difference|1.73||||0.251|TWO_SIDED|95.0|-1.24|4.71|||Mixed models repeated measures analysis|||Week 12||4.71|-1.24|0.251
72556676|NCT01592240|144644583|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.53||||0.724|TWO_SIDED|95.0|-2.43|3.5|||Mixed models repeated measures analysis|||Week 12||3.50|-2.43|0.724
72556677|NCT01592240|144644583|SUPERIORITY_OR_OTHER||Adjusted mean difference|4.45||||0.007|TWO_SIDED|95.0|1.21|7.7|||Mixed models repeated measures analysis|||Week 12||7.70|1.21|0.007
72556678|NCT01592240|144644583|SUPERIORITY_OR_OTHER||Adjusted mean difference|3.86||||0.019|TWO_SIDED|95.0|0.63|7.09|||Mixed models repeated measures analysis|||Week 12||7.09|0.63|0.019
72556679|NCT01592240|144644583|SUPERIORITY_OR_OTHER||Adjusted mean difference|1.72||||0.225|TWO_SIDED|95.0|-1.07|4.51|||Mixed models repeated measures analysis|||Week 24||4.51|-1.07|0.225
72381634|NCT00708071|144271791|SUPERIORITY_OR_OTHER||Difference in proportions|0.038|||||TWO_SIDED|90.0|-0.17|0.24|||||Difference in proportions = SoC - FS VH S/D 4|||0.24|-0.17|
72381635|NCT00708071|144271792|SUPERIORITY_OR_OTHER|||||||0.645|||||||Two-sided Wilcoxon paired sample tests|alpha = 10%||||||0.645
72381636|NCT00708071|144271793|SUPERIORITY_OR_OTHER|||||||0.103||90.0|||||Two-sided Wilcoxon paired sample tests|alpha = 10%||||||0.103
72381637|NCT00708071|144271794|SUPERIORITY_OR_OTHER|||||||0.833||90.0|||||Two-sided Wilcoxon paired sample tests|alpha = 10%||||||0.833
72381638|NCT00708071|144271795|SUPERIORITY_OR_OTHER|||||||0.501||90.0|||||Two-sided Wilcoxon paired sample tests|alpha = 10%||||||0.501
72381639|NCT00708071|144271796|SUPERIORITY_OR_OTHER|||||||0.247||90.0|||||Two-sided Wilcoxon paired sample tests|alpha = 10%||||||0.247
72381640|NCT00708071|144271797|SUPERIORITY_OR_OTHER|||||||0.715||90.0|||||Two-sided Wilcoxon paired sample tests|alpha = 10%||||||0.715
72381641|NCT00708071|144271799|SUPERIORITY_OR_OTHER|||||||0.754||90.0|||||Two-sided Wilcoxon paired sample tests|alpha = 10%||||||0.754
72381642|NCT00708071|144271800|SUPERIORITY_OR_OTHER|||||||0.388||90.0|||||Two-sided Wilcoxon paired sample tests|alpha = 10%||||||0.388
72381643|NCT00708071|144271801|SUPERIORITY_OR_OTHER|||||||0.234||90.0|||||Two-sided Wilcoxon paired sample tests|alpha = 10%||||||0.234
72556680|NCT01592240|144644583|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.79||||0.571|TWO_SIDED|95.0|-1.97|3.56|||Mixed models repeated measures analysis|||Week 24||3.56|-1.97|0.571
72556681|NCT01592240|144644583|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.49||||0.725|TWO_SIDED|95.0|-2.25|3.24|||Mixed models repeated measures analysis|||Week 24||3.24|-2.25|0.725
72556682|NCT01592240|144644583|SUPERIORITY_OR_OTHER||Adjusted mean difference|2.01||||0.268|TWO_SIDED|95.0|-1.56|5.57|||Mixed models repeated measures analysis|||Week 24||5.57|-1.56|0.268
72556683|NCT01592240|144644583|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.01||||0.996|TWO_SIDED|95.0|-3.55|3.54|||Mixed models repeated measures analysis|||Week 24||3.54|-3.55|0.996
72556684|NCT01592240|144644584|SUPERIORITY_OR_OTHER||Adjusted mean difference|3.41||||0.246|TWO_SIDED|95.0|-2.38|9.21|||Mixed models repeated measures analysis|||Week 12||9.21|-2.38|0.246
72556685|NCT01592240|144644584|SUPERIORITY_OR_OTHER||Adjusted mean difference|2.62||||0.371|TWO_SIDED|95.0|-3.14|8.38|||Mixed models repeated measures analysis|||Week 12||8.38|-3.14|0.371
72556686|NCT01592240|144644584|SUPERIORITY_OR_OTHER||Adjusted mean difference|1.35||||0.643|TWO_SIDED|95.0|-4.4|7.1|||Mixed models repeated measures analysis|||Week 12||7.10|-4.40|0.643
72556687|NCT01592240|144644584|SUPERIORITY_OR_OTHER||Adjusted mean difference|7.66||||0.018|TWO_SIDED|95.0|1.33|13.99|||Mixed models repeated measures analysis|||Week 12||13.99|1.33|0.018
72556688|NCT01592240|144644584|SUPERIORITY_OR_OTHER||Adjusted mean difference|6.52||||0.043|TWO_SIDED|95.0|0.22|12.83|||Mixed models repeated measures analysis|||Week 12||12.83|0.22|0.043
72556689|NCT01592240|144644584|SUPERIORITY_OR_OTHER||Adjusted mean difference|3.9||||0.16|TWO_SIDED|95.0|-1.56|9.36|||Mixed models repeated measures analysis|||Week 24||9.36|-1.56|0.160
72556690|NCT01592240|144644584|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.85||||0.758|TWO_SIDED|95.0|-4.56|6.25|||Mixed models repeated measures analysis|||Week 24||6.25|-4.56|0.758
72556691|NCT01592240|144644584|SUPERIORITY_OR_OTHER||Adjusted mean difference|2.57||||0.347|TWO_SIDED|95.0|-2.81|7.95|||Mixed models repeated measures analysis|||Week 24||7.95|-2.81|0.347
72556692|NCT01592240|144644584|SUPERIORITY_OR_OTHER||Adjusted mean difference|2.99||||0.343|TWO_SIDED|95.0|-3.22|9.21|||Mixed models repeated measures analysis|||Week 24||9.21|-3.22|0.343
72556693|NCT01592240|144644584|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.7||||0.824|TWO_SIDED|95.0|-6.87|5.48|||Mixed models repeated measures analysis|||Week 24||5.48|-6.87|0.824
72556694|NCT01592240|144644585|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-18.55|||<|0.001|TWO_SIDED|95.0|-25.44|-11.67|||Mixed models repeated measures analysis|||Week 12||-11.67|-25.44|<0.001
72556695|NCT01592240|144644585|SUPERIORITY_OR_OTHER||Adjusted mean difference|-27.67|||<|0.001|TWO_SIDED|95.0|-34.55|-20.79|||Mixed models repeated measures analysis|||Week 12||-20.79|-34.55|<0.001
72556696|NCT01592240|144644585|SUPERIORITY_OR_OTHER||Adjusted mean difference|-32.09|||<|0.001|TWO_SIDED|95.0|-38.95|-25.22|||Mixed models repeated measures analysis|||Week 12||-25.22|-38.95|<0.001
72381644|NCT00708071|144271802|SUPERIORITY_OR_OTHER|||||||0.688||90.0||||Two-sided Wilcoxon paired sample tests|Two-sided Wilcoxon paired sample tests|alpha = 10%||||||0.688
72381645|NCT00708071|144271803|SUPERIORITY_OR_OTHER|||||||0.625||90.0|||||Two-sided Wilcoxon paired sample tests|alpha = 10%||||||0.625
72434159|NCT01018511|144381833|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.17||0.223|TWO_SIDED|95.0|-0.6|0.1||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs TOCAS.||0.1|-0.6|0.223
72381646|NCT00708071|144271804|SUPERIORITY_OR_OTHER|||||||0.688||90.0|||||Two-sided Wilcoxon paired sample tests|alpha = 10%||||||0.688
72381647|NCT00708071|144271805|SUPERIORITY_OR_OTHER|||||||1||90.0|||||Two-sided Wilcoxon paired sample tests|alpha = 10%||||||1.000
72381648|NCT00708071|144271806|SUPERIORITY_OR_OTHER|||||||0.521||90.0|||||Two-sided Wilcoxon paired sample tests|alpha = 10%||||||0.521
72381649|NCT00708071|144271807|SUPERIORITY_OR_OTHER|||||||0.324||90.0||||alpha = 10%|Two-sided Wilcoxon paired sample tests|||||||0.324
72434160|NCT01018511|144381833|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-1.2|STANDARD_ERROR_OF_MEAN|0.17|<|0.001|TWO_SIDED|95.0|-1.5|-0.8||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.||-0.8|-1.5|< 0.001
72434161|NCT01018511|144381833|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.7|STANDARD_ERROR_OF_MEAN|0.17|<|0.001|TWO_SIDED|95.0|-1.1|-0.4||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate||Mean change vs placebo.||-0.4|-1.1|< 0.001
72434162|NCT01018511|144381833|SUPERIORITY_OR_OTHER_LEGACY||least squares mean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.17||0.002|TWO_SIDED|95.0|-0.9|-0.2||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.||-0.2|-0.9|0.002
72434163|NCT01018511|144381834|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|23.1|STANDARD_ERROR_OF_MEAN|3.33|<|0.001|TWO_SIDED|95.0|16.6|29.6||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs TOCAS.||29.6|16.6|< 0.001
72434164|NCT01018511|144381834|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|23.2|STANDARD_ERROR_OF_MEAN|3.36|<|0.001|TWO_SIDED|95.0|16.6|29.8||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs TOCAS.||29.8|16.6|< 0.001
72434165|NCT01018511|144381834|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|27.4|STANDARD_ERROR_OF_MEAN|3.27|<|0.001|TWO_SIDED|95.0|21.0|33.9||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.||33.9|21.0|< 0.001
72434166|NCT01018511|144381834|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|27.6|STANDARD_ERROR_OF_MEAN|3.3|<|0.001|TWO_SIDED|95.0|21.1|34.1||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.||34.1|21.1|< 0.001
72434167|NCT01018511|144381834|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|4.4|STANDARD_ERROR_OF_MEAN|3.32||0.189|TWO_SIDED|95.0|-2.2|10.9||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate||Mean change vs placebo.||10.9|-2.2|0.189
72434168|NCT01018511|144381835|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|14.5|STANDARD_ERROR_OF_MEAN|7.51||0.053|TWO_SIDED|95.0|-0.2|29.3||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs TOCAS.||29.3|-0.2|0.053
72434169|NCT01018511|144381835|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|14.7|STANDARD_ERROR_OF_MEAN|7.59||0.053|TWO_SIDED|95.0|-0.2|29.6||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs TOCAS.||29.6|-0.2|0.053
72434170|NCT01018511|144381835|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|18.5|STANDARD_ERROR_OF_MEAN|7.37||0.012|TWO_SIDED|95.0|4.1|33.0||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.||33.0|4.1|0.012
72434171|NCT01018511|144381835|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|18.7|STANDARD_ERROR_OF_MEAN|7.45||0.012|TWO_SIDED|95.0|4.1|33.4||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.||33.4|4.1|0.012
72434172|NCT01018511|144381835|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|4.0|STANDARD_ERROR_OF_MEAN|7.49||0.591|TWO_SIDED|95.0|-10.7|18.7||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.||18.7|-10.7|0.591
72434173|NCT01018511|144381836|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.25||0.616|TWO_SIDED|95.0|-0.6|0.4||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs TOCAS.||0.4|-0.6|0.616
72434174|NCT01018511|144381836|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.25||0.319|TWO_SIDED|95.0|-0.7|0.2||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs TOCAS.||0.2|-0.7|0.319
72504712|NCT01954628|144540211|SUPERIORITY_OR_OTHER||Least sqaure mean difference|-0.34||||0.588|TWO_SIDED|95.0|-1.57|0.89|||ANOVA|||ANOVA model with fixed factors treatment, region and baseline total CAT score as covariate were used. Missing post-treatment data were imputed using the Last Observation Carried Forward principle.||0.89|-1.57|0.588
72434175|NCT01018511|144381836|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-1.0|STANDARD_ERROR_OF_MEAN|0.24|<|0.001|TWO_SIDED|95.0|-1.5|-0.6||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.||-0.6|-1.5|< 0.001
72434176|NCT01018511|144381836|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-1.2|STANDARD_ERROR_OF_MEAN|0.25|<|0.001|TWO_SIDED|95.0|-1.7|-0.7||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.||-0.7|-1.7|< 0.001
72434177|NCT01018511|144381836|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.9|STANDARD_ERROR_OF_MEAN|0.25|<|0.001|TWO_SIDED|95.0|-1.4|-0.4||No adjustments to multiplicity were made|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.||-0.4|-1.4|< 0.001
72434178|NCT01018511|144381837|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|0.1|STANDARD_ERROR_OF_MEAN|0.22||0.591|TWO_SIDED|95.0|-0.3|0.5||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs TOCAS.||0.5|-0.3|0.591
72434179|NCT01018511|144381837|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|0.3|STANDARD_ERROR_OF_MEAN|0.21||0.102|TWO_SIDED|95.0|-0.1|0.8||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs TOCAS.||0.8|-0.1|0.102
72434180|NCT01018511|144381837|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.19||0.204|TWO_SIDED|95.0|-0.6|0.1||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.||0.1|-0.6|0.204
72434181|NCT01018511|144381837|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.19||0.936|TWO_SIDED|95.0|-0.4|0.4||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.||0.4|-0.4|0.936
72434182|NCT01018511|144381837|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.21||0.081|TWO_SIDED|95.0|-0.8|0.0||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.||0.0|-0.8|0.081
72556697|NCT01592240|144644585|SUPERIORITY_OR_OTHER||Adjusted mean difference|-14.56|||<|0.001|TWO_SIDED|95.0|-22.89|-6.24|||Mixed models repeated measures analysis|||Week 12||-6.24|-22.89|<0.001
72556698|NCT01592240|144644585|SUPERIORITY_OR_OTHER||Adjusted mean difference|-28.5|||<|0.001|TWO_SIDED|95.0|-36.83|-20.16|||Mixed models repeated measures analysis|||Week 12||-20.16|-36.83|<0.001
72556699|NCT01592240|144644585|SUPERIORITY_OR_OTHER||Adjusted mean difference|-19.67|||<|0.001|TWO_SIDED|95.0|-27.07|-12.27|||Mixed models repeated measures analysis|||Week 24||-12.27|-27.07|<0.001
72556700|NCT01592240|144644585|SUPERIORITY_OR_OTHER||Adjusted mean difference|-28.17|||<|0.001|TWO_SIDED|95.0|-35.52|-20.82|||Mixed models repeated measures analysis|||Week 24||-20.82|-35.52|<0.001
72434183|NCT01018511|144381838|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|0.2|STANDARD_ERROR_OF_MEAN|0.24||0.511|TWO_SIDED|95.0|-0.3|0.6||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs TOCAS.||0.6|-0.3|0.511
72556701|NCT01592240|144644585|SUPERIORITY_OR_OTHER||Adjusted mean difference|-25.41|||<|0.001|TWO_SIDED|95.0|-32.73|-18.09|||Mixed models repeated measures analysis|||Week 24||-18.09|-32.73|<0.001
72556702|NCT01592240|144644585|SUPERIORITY_OR_OTHER||Adjusted mean difference|-12.72|||<|0.001|TWO_SIDED|95.0|-19.35|-6.09|||Mixed models repeated measures analysis|||Week 24||-6.09|-19.35|<0.001
72556703|NCT01592240|144644585|SUPERIORITY_OR_OTHER||Adjusted mean difference|-16.85|||<|0.001|TWO_SIDED|95.0|-23.47|-10.23|||Mixed models repeated measures analysis|||Week 24||-10.23|-23.47|<0.001
72381650|NCT00708071|144271808|SUPERIORITY_OR_OTHER|||||||0.661||90.0|||||Two-sided Wilcoxon paired sample tests|alpha = 10%||||||0.661
72381651|NCT00708071|144271809|SUPERIORITY_OR_OTHER|||||||1||90.0|||||Two-sided Wilcoxon paired sample tests|alpha = 10%||||||1.000
72381652|NCT00708071|144271810|SUPERIORITY_OR_OTHER|||||||0.699||90.0|||||Two-sided Wilcoxon paired sample tests|alpha = 10%||||||0.699
72381653|NCT00708071|144271813|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||two-sided paired t-test|alpha = 5%||||||0.0010
72381654|NCT00708071|144271815|SUPERIORITY_OR_OTHER||Difference in proportions|0.182||||0.014|TWO_SIDED|95.0|0.04|0.34|||McNemar's test of paired proportions|Alpha = 5%|Difference in Proportions = (Number of SoC Participants with Hematoma/Seroma) - (Number of FS VH S/D 4 Participants with Hematoma/Seroma)|||0.34|0.04|0.014
72381655|NCT02140775|144271821|SUPERIORITY|||||||0.602|||||||Chi-squared|degrees of freedom = 1||A Chi-Square test was conducted between the treatment groups and the dichotomous outcome of successful achievement of employment goal.||||.602
72381656|NCT02140775|144271822|SUPERIORITY||Mean Difference (Final Values)|-3.74|STANDARD_ERROR_OF_MEAN|2.0||0.066|TWO_SIDED|95.0|-7.75|0.26|||t-test, 2 sided|||||0.26|-7.75|.066
72556704|NCT01592240|144644586|SUPERIORITY_OR_OTHER||Adjusted mean difference|-21.58|||<|0.001|TWO_SIDED|95.0|-29.23|-13.92|||Mixed models repeated measures analysis|||Week 12||-13.92|-29.23|<0.001
72556705|NCT01592240|144644586|SUPERIORITY_OR_OTHER||Adjusted mean difference|-30.54|||<|0.001|TWO_SIDED|95.0|-38.19|-22.89|||Mixed models repeated measures analysis|||Week 12||-22.89|-38.19|<0.001
72556706|NCT01592240|144644586|SUPERIORITY_OR_OTHER||Adjusted mean difference|-35.95|||<|0.001|TWO_SIDED|95.0|-43.59|-28.31|||Mixed models repeated measures analysis|||Week 12||-28.31|-43.59|<0.001
72556707|NCT01592240|144644586|SUPERIORITY_OR_OTHER||Adjusted mean difference|-17.14|||<|0.001|TWO_SIDED|95.0|-25.87|-8.41|||Mixed models repeated measures analysis|||Week 12||-8.41|-25.87|<0.001
72556708|NCT01592240|144644586|SUPERIORITY_OR_OTHER||Adjusted mean difference|-30.72|||<|0.001|TWO_SIDED|95.0|-39.45|-21.98|||Mixed models repeated measures analysis|||Week 12||-21.98|-39.45|<0.001
72434184|NCT01018511|144381838|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|0.3|STANDARD_ERROR_OF_MEAN|0.24||0.182|TWO_SIDED|95.0|-0.2|0.8||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs TOCAS.||0.8|-0.2|0.182
72556709|NCT01592240|144644586|SUPERIORITY_OR_OTHER||Adjusted mean difference|-22.09|||<|0.001|TWO_SIDED|95.0|-30.32|-13.86|||Mixed models repeated measures analysis|||Week 24||-13.86|-30.32|<0.001
72556710|NCT01592240|144644586|SUPERIORITY_OR_OTHER||Adjusted mean difference|-30.95|||<|0.001|TWO_SIDED|95.0|-39.13|-22.77|||Mixed models repeated measures analysis|||Week 24||-22.77|-39.13|<0.001
72381657|NCT02140775|144271823|SUPERIORITY||Mean Difference (Final Values)|-3.25|STANDARD_ERROR_OF_MEAN|7.68||0.674|TWO_SIDED|95.0|-18.59|12.09|||t-test, 2 sided|||||12.09|-18.59|.674
72381658|NCT00945854|144271824|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANCOVA|||||||<0.05
72381659|NCT05308290|144271844|OTHER|||||||0.6||||||the a priori threshold for statistical significance was \<0.05|t-test, 2 sided|||||||0.60
72381660|NCT05308290|144271845|OTHER|||||||0.6||||||the a priori threshold for statistical significance was \<0.05|t-test, 2 sided|||||||0.60
72381661|NCT05308290|144271846|OTHER|||||||1||||||the a priori threshold for statistical significance was \<0.05|Fisher Exact|||||||1.0
72381662|NCT05308290|144271847|OTHER|||||||1||||||the a priori threshold for statistical significance was \<0.05|Fisher Exact|||||||1.0
72381663|NCT05308290|144271848|OTHER|||||||0.28||||||the a priori threshold for statistical significance was \<0.05|Fisher Exact|||||||0.28
72381664|NCT04437368|144271855|SUPERIORITY||LS Mean Difference|0.291|STANDARD_ERROR_OF_MEAN|0.2838|||TWO_SIDED|90.0|-0.195|0.777|||mixed model repeated measures|||Week 12||0.777|-0.195|
72381665|NCT04437368|144271855|SUPERIORITY||LS Mean Difference|0.282|STANDARD_ERROR_OF_MEAN|0.2843|||TWO_SIDED|90.0|-0.206|0.769|||mixed model repeated measures|||Week 12||0.769|-0.206|
72381666|NCT04437368|144271855|SUPERIORITY||LS Mean Difference|0.658|STANDARD_ERROR_OF_MEAN|0.373|||TWO_SIDED|90.0|0.017|1.299|||mixed model repeated measures|||Week 24||1.299|0.017|
72381667|NCT04437368|144271855|SUPERIORITY||LS Mean Difference|0.84|STANDARD_ERROR_OF_MEAN|0.3791|||TWO_SIDED|90.0|0.189|1.49|||mixed model repeated measures|||Week 24||1.490|0.189|
72381668|NCT04437368|144271855|SUPERIORITY||LS Mean Difference|0.668|STANDARD_ERROR_OF_MEAN|0.4954|||TWO_SIDED|90.0|-0.177|1.512|||mixed model repeated measures|||Week 36||1.512|-0.177|
72381669|NCT04437368|144271855|SUPERIORITY||LS Mean Difference|0.912|STANDARD_ERROR_OF_MEAN|0.4887|||TWO_SIDED|90.0|0.078|1.746|||mixed model repeated measures|||Week 36||1.746|0.078|
72381670|NCT04437368|144271855|SUPERIORITY||LS Mean Difference|0.976|STANDARD_ERROR_OF_MEAN|0.4813|||TWO_SIDED|90.0|0.15|1.803|||mixed model repeated measures|||Week 48||1.803|0.150|
72434185|NCT01018511|144381838|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.22||0.552|TWO_SIDED|95.0|-0.6|0.3||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.||0.3|-0.6|0.552
72381671|NCT04437368|144271855|SUPERIORITY||LS Mean Difference|1.233|STANDARD_ERROR_OF_MEAN|0.4573|||TWO_SIDED|90.0|0.445|2.022|||mixed model repeated measures|||Week 48||2.022|0.445|
72381672|NCT04437368|144271856|SUPERIORITY||LS Mean Difference|1.769|STANDARD_ERROR_OF_MEAN|1.2808|||TWO_SIDED|90.0|-0.441|3.979|||mixed model repeated measures|||Week 72||3.979|-0.441|
72381673|NCT04437368|144271856|SUPERIORITY||LS Mean Difference|1.274|STANDARD_ERROR_OF_MEAN|1.2349|||TWO_SIDED|90.0|-0.863|3.412|||mixed model repeated measures|||Week 72||3.412|-0.863|
72381674|NCT04437368|144271856|SUPERIORITY||LS Mean Difference|2.041|STANDARD_ERROR_OF_MEAN|1.4177|||TWO_SIDED|90.0|-0.386|4.468|||mixed model repeated measures|||Week 96||4.468|-0.386|
72381675|NCT04437368|144271856|SUPERIORITY||LS Mean|1.278|STANDARD_ERROR_OF_MEAN|1.3857|||TWO_SIDED|90.0|-1.099|3.655|||mixed model repeated measures|||Week 96||3.655|-1.099|
72381676|NCT04437368|144271862|SUPERIORITY||LS Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|5.49|||TWO_SIDED|90.0|-10.3|8.1|||mixed model repeated measures|||Week 12||8.1|-10.3|
72381677|NCT04437368|144271862|SUPERIORITY||LS Mean Difference|-6.3|STANDARD_ERROR_OF_MEAN|5.96|||TWO_SIDED|90.0|-16.3|3.7|||mixed model repeated measures|||Week 12||3.7|-16.3|
72381678|NCT04437368|144271862|SUPERIORITY||LS Mean Difference|-5.2|STANDARD_ERROR_OF_MEAN|5.54|||TWO_SIDED|90.0|-14.5|4.1|||mixed model repeated measures|||Week 24||4.1|-14.5|
72381679|NCT04437368|144271862|SUPERIORITY||LS Mean Difference|-11.7|STANDARD_ERROR_OF_MEAN|6.0|||TWO_SIDED|90.0|-21.7|-1.6|||mixed model repeated measures|||Week 24||-1.6|-21.7|
72381680|NCT04437368|144271862|SUPERIORITY||LS Mean Difference|-9.0|STANDARD_ERROR_OF_MEAN|5.63|||TWO_SIDED|90.0|-18.4|0.5|||mixed model repeated measures|||Week 36||0.5|-18.4|
72381681|NCT04437368|144271862|SUPERIORITY||LS Mean Difference|-11.9|STANDARD_ERROR_OF_MEAN|6.08|||TWO_SIDED|90.0|-22.1|-1.7|||mixed model repeated measures|||Week 36||-1.7|-22.1|
72381682|NCT04437368|144271862|SUPERIORITY||LS Mean Difference|-2.9|STANDARD_ERROR_OF_MEAN|5.88|||TWO_SIDED|90.0|-12.7|6.9|||mixed model repeated measures|||Week 48||6.9|-12.7|
72381683|NCT04437368|144271862|SUPERIORITY||LS Mean Difference|-7.6|STANDARD_ERROR_OF_MEAN|6.14|||TWO_SIDED|90.0|-17.9|2.7|||mixed model repeated measures|||Week 48||2.7|-17.9|
72381684|NCT04437368|144271862|SUPERIORITY||LS Mean Difference|2.6|STANDARD_ERROR_OF_MEAN|5.96|||TWO_SIDED|90.0|-7.4|12.5|||mixed model repeated measures|||Week 72||12.5|-7.4|
72381685|NCT04437368|144271862|SUPERIORITY||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|6.18|||TWO_SIDED|90.0|-11.1|9.6|||mixed model repeated measures|||Week 72||9.6|-11.1|
72381686|NCT04437368|144271862|SUPERIORITY||LS Mean Difference|1.4|STANDARD_ERROR_OF_MEAN|6.07|||TWO_SIDED|90.0|-8.7|11.5|||mixed model repeated measures|||Week 96||11.5|-8.7|
72381687|NCT04437368|144271862|SUPERIORITY||LS Mean Difference|-3.0|STANDARD_ERROR_OF_MEAN|6.47|||TWO_SIDED|90.0|-13.8|7.8|||mixed model repeated measures|||Week 96||7.8|-13.8|
72381688|NCT04105543|144271914|OTHER|nonparametric rank test|Median Difference (Final Values)|-4.22||||0.173|TWO_SIDED|95.0|-12.64|4.24|||Wilcoxon Signed Rank Tests|||Wilcoxon Signed Rank Tests for MDADI Composite Baseline to 3 months (n=9)||4.24|-12.64|0.173
72556711|NCT01592240|144644586|SUPERIORITY_OR_OTHER||Adjusted mean difference|-27.23|||<|0.001|TWO_SIDED|95.0|-35.38|-19.09|||Mixed models repeated measures analysis|||Week 24||-19.09|-35.38|<0.001
72556712|NCT01592240|144644586|SUPERIORITY_OR_OTHER||Adjusted mean difference|-15.34|||<|0.001|TWO_SIDED|95.0|-22.9|-7.78|||Mixed models repeated measures analysis|||Week 24||-7.78|-22.90|<0.001
72556713|NCT01592240|144644586|SUPERIORITY_OR_OTHER||Adjusted mean difference|-19.15|||<|0.001|TWO_SIDED|95.0|-26.7|-11.59|||Mixed models repeated measures analysis|||Week 24||-11.59|-26.70|<0.001
72556714|NCT01592240|144644587|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|1.77||||0.667|TWO_SIDED|95.0|-6.33|9.88|||Mixed models repeated measures analysis|||Week 12||9.88|-6.33|0.667
72556715|NCT01592240|144644587|SUPERIORITY_OR_OTHER||Adjusted mean difference|5.44||||0.187|TWO_SIDED|95.0|-2.66|13.54|||Mixed models repeated measures analysis|||Week 12||13.54|-2.66|0.187
72556716|NCT01592240|144644587|SUPERIORITY_OR_OTHER||Adjusted mean difference|3.82||||0.352|TWO_SIDED|95.0|-4.25|11.9|||Mixed models repeated measures analysis|||Week 12||11.90|-4.25|0.352
72556717|NCT01592240|144644587|SUPERIORITY_OR_OTHER||Adjusted mean difference|5.6||||0.09|TWO_SIDED|95.0|-0.89|12.09|||Mixed models repeated measures analysis|||Week 12||12.09|-0.89|0.090
72556718|NCT01592240|144644587|SUPERIORITY_OR_OTHER||Adjusted mean difference|4.36||||0.184|TWO_SIDED|95.0|-2.1|10.82|||Mixed models repeated measures analysis|||Week 12||10.82|-2.10|0.184
72556719|NCT01592240|144644587|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.59||||0.879|TWO_SIDED|95.0|-7.09|8.28|||Mixed models repeated measures analysis|||Week 24||8.28|-7.09|0.879
72556720|NCT01592240|144644587|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.43||||0.911|TWO_SIDED|95.0|-7.17|8.02|||Mixed models repeated measures analysis|||Week 24||8.02|-7.17|0.911
72556721|NCT01592240|144644587|SUPERIORITY_OR_OTHER||Adjusted mean difference|4.12||||0.283|TWO_SIDED|95.0|-3.44|11.69|||Mixed models repeated measures analysis|||Week 24||11.69|-3.44|0.283
72556722|NCT01592240|144644587|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.41||||0.728|TWO_SIDED|95.0|-9.41|6.59|||Mixed models repeated measures analysis|||Week 24||6.59|-9.41|0.728
72556723|NCT01592240|144644587|SUPERIORITY_OR_OTHER||Adjusted mean difference|-2.19||||0.587|TWO_SIDED|95.0|-10.13|5.75|||Mixed models repeated measures analysis|||Week 24||5.75|-10.13|0.587
72381689|NCT04105543|144271914|OTHER|nonparametric rank test|Median Difference (Final Values)|-9.998||||0.225|TWO_SIDED|95.0|-28.43|7.39|||Wilcoxon Signed Rank Test|||Wilcoxon Signed Rank Test for MDADI Composite Baseline to 6 months (n=5)||7.39|-28.43|0.225
72381690|NCT04105543|144271915|OTHER|nonparametric rank test|Median Difference (Final Values)|-0.037||||0.779|TWO_SIDED|95.0|-0.246|0.09|||Wilcoxon Signed Rank Tests|||Wilcoxon Signed Rank Tests for Stimulated Saliva Flow Baseline to 3 months (n=8)||0.09|-0.246|0.779
72618637|NCT01026038|144768106|SUPERIORITY_OR_OTHER||GMC ratrio|1.82|||||TWO_SIDED|95.0|1.25|2.66||||||Serotype 19A: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||2.66|1.25|
72381691|NCT04105543|144271915|OTHER|nonparametric rank test|Median Difference (Final Values)|-0.049||||0.465|TWO_SIDED|95.0|-0.218|0.12|||Wilcoxon Signed Rank Test|||Wilcoxon Signed Rank Test for Stimulated Saliva Flow Baseline to 6 months (n=4)||0.12|-0.218|0.465
72381692|NCT04105543|144271916|OTHER|nonparametric rank test|Median Difference (Final Values)|-4.444||||0.213|TWO_SIDED|95.0|-14.4|4.4|||Wilcoxon Signed Rank Tests|||Wilcoxon Signed Rank Tests for EORTC QLQ-C30 Functional Score Baseline to 3 months (n=9)||4.4|-14.4|0.213
72381693|NCT04105543|144271916|OTHER|nonparametric rank test|Median Difference (Final Values)|-6.667||||0.686|TWO_SIDED|95.0|-17.8|20.0|||Wilcoxon Signed Rank Test|||Wilcoxon Signed Rank Test for EORTC QLQ-C30 Functional Scores Baseline to 6 months (n=5)||20|-17.8|0.686
72381694|NCT04105543|144271916|OTHER|nonparametric rank test|Median Difference (Final Values)|3.846||||0.498|TWO_SIDED|95.0|-0.769|12.82|||Wilcoxon Signed Rank Test|||Wilcoxon Signed Rank Tests for EORTC QLQ-C30 Symptom Score Baseline to 3 months (n=9)||12.82|-0.769|0.498
72556724|NCT01592240|144644588|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.66||||0.89|TWO_SIDED|95.0|-10.05|8.74|||Mixed models repeated measures analysis|||Week 12||8.74|-10.05|0.890
72556725|NCT01592240|144644588|SUPERIORITY_OR_OTHER||Adjusted mean difference|2.32||||0.625|TWO_SIDED|95.0|-7.04|11.68|||Mixed models repeated measures analysis|||Week 12||11.68|-7.04|0.625
72556726|NCT01592240|144644588|SUPERIORITY_OR_OTHER||Adjusted mean difference|6.54||||0.172|TWO_SIDED|95.0|-2.86|15.94|||Mixed models repeated measures analysis|||Week 12||15.94|-2.86|0.172
72556727|NCT01592240|144644588|SUPERIORITY_OR_OTHER||Adjusted mean difference|3.5||||0.109|TWO_SIDED|95.0|-0.79|7.8|||Mixed models repeated measures analysis|||Week 12||7.80|-0.79|0.109
72556728|NCT01592240|144644588|SUPERIORITY_OR_OTHER||Adjusted mean difference|2.67||||0.218|TWO_SIDED|95.0|-1.6|6.94|||Mixed models repeated measures analysis|||Week 12||6.94|-1.60|0.218
72556729|NCT01592240|144644588|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.86||||0.812|TWO_SIDED|95.0|-8.01|6.29|||Mixed models repeated measures analysis|||Week 24||6.29|-8.01|0.812
72556730|NCT01592240|144644588|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.15||||0.749|TWO_SIDED|95.0|-8.24|5.94|||Mixed models repeated measures analysis|||Week 24||5.94|-8.24|0.749
72556731|NCT01592240|144644588|SUPERIORITY_OR_OTHER||Adjusted mean difference|5.82||||0.108|TWO_SIDED|95.0|-1.29|12.93|||Mixed models repeated measures analysis|||Week 24||12.93|-1.29|0.108
72556732|NCT01592240|144644588|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.83||||0.752|TWO_SIDED|95.0|-5.99|4.34|||Mixed models repeated measures analysis|||Week 24||4.34|-5.99|0.752
72556733|NCT01592240|144644588|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.55||||0.55|TWO_SIDED|95.0|-6.68|3.57|||Mixed models repeated measures analysis|||Week 24||3.57|-6.68|0.550
72556734|NCT01592240|144644589|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.19||||0.893|TWO_SIDED|95.0|-2.62|3.0|||Mixed models repeated measures analysis|||Week 12||3.00|-2.62|0.893
72556735|NCT01592240|144644589|SUPERIORITY_OR_OTHER||Adjusted mean difference|1.33||||0.355|TWO_SIDED|95.0|-1.49|4.15|||Mixed models repeated measures analysis|||Week 12||4.15|-1.49|0.355
72556736|NCT01592240|144644589|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.64||||0.655|TWO_SIDED|95.0|-3.45|2.17|||Mixed models repeated measures analysis|||Week 12||2.17|-3.45|0.655
72556737|NCT01592240|144644589|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.49||||0.719|TWO_SIDED|95.0|-3.2|2.21|||Mixed models repeated measures analysis|||Week 12||2.21|-3.20|0.719
72556738|NCT01592240|144644589|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.41||||0.768|TWO_SIDED|95.0|-2.31|3.12|||Mixed models repeated measures analysis|||Week 12||3.12|-2.31|0.768
72556739|NCT01592240|144644589|SUPERIORITY_OR_OTHER||Adjusted mean difference|1.66||||0.199|TWO_SIDED|95.0|-0.88|4.2|||Mixed models repeated measures analysis|||Week 24||4.20|-0.88|0.199
72556740|NCT01592240|144644589|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.9||||0.483|TWO_SIDED|95.0|-1.62|3.41|||Mixed models repeated measures analysis|||Week 24||3.41|-1.62|0.483
72556741|NCT01592240|144644589|SUPERIORITY_OR_OTHER||Adjusted mean difference|1.03||||0.42|TWO_SIDED|95.0|-1.49|3.56|||Mixed models repeated measures analysis|||Week 24||3.56|-1.49|0.420
72556742|NCT01592240|144644589|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.69||||0.488|TWO_SIDED|95.0|-2.67|1.28|||Mixed models repeated measures analysis|||Week 24||1.28|-2.67|0.488
72556743|NCT01592240|144644589|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.39||||0.694|TWO_SIDED|95.0|-2.36|1.58|||Mixed models repeated measures analysis|||Week 24||1.58|-2.36|0.694
72556744|NCT01592240|144644590|SUPERIORITY_OR_OTHER||Adjusted mean difference|10.29||||0.527|TWO_SIDED|95.0|-21.73|42.3|||Mixed models repeated measures analysis|||Week 12||42.30|-21.73|0.527
72556745|NCT01592240|144644590|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.39||||0.981|TWO_SIDED|95.0|-31.49|32.26|||Mixed models repeated measures analysis|||Week 12||32.26|-31.49|0.981
72556746|NCT01592240|144644590|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.54||||0.974|TWO_SIDED|95.0|-31.72|32.8|||Mixed models repeated measures analysis|||Week 12||32.80|-31.72|0.974
72556747|NCT01592240|144644590|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.58||||0.64|TWO_SIDED|95.0|-8.25|5.09|||Mixed models repeated measures analysis|||Week 12||5.09|-8.25|0.640
72556748|NCT01592240|144644590|SUPERIORITY_OR_OTHER||Adjusted mean difference|1.08||||0.75|TWO_SIDED|95.0|-5.61|7.77|||Mixed models repeated measures analysis|||Week 12||7.77|-5.61|0.750
72381695|NCT04105543|144271916|OTHER|nonparametric rank test|Median Difference (Final Values)|10.256||||0.416|TWO_SIDED|95.0|-15.39|35.89|||Wilcoxon Signed Rank Test|||Wilcoxon Signed Rank Test for EORTC QLQ-C30 Symptom Scores Baseline to 6 months (n=5)||35.89|-15.39|0.416
72381696|NCT04105543|144271916|OTHER|nonparametric rank test|Median Difference (Final Values)|-8.33||||0.778|TWO_SIDED|95.0|-20.84|16.67|||Wilcoxon Signed Rank Test|||Wilcoxon Signed Rank Tests for EORTC QLQ-C30 Global Health Status Score Baseline to 3 months (n=9)||16.67|-20.84|0.778
72381697|NCT04105543|144271916|OTHER|nonparametric rank test|Median Difference (Final Values)|0.0||||0.89|TWO_SIDED|95.0|-25.0|25.0|||Wilcoxon Signed Rank Test|||Wilcoxon Signed Rank Test for EORTC QLQ-C30 Global Health Status Scores Baseline to 6 months (n=5)||25|-25|0.89
72434186|NCT01018511|144381838|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.22||0.891|TWO_SIDED|95.0|-0.4|0.5||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo||0.5|-0.4|0.891
72556749|NCT01592240|144644590|SUPERIORITY_OR_OTHER||Adjusted mean difference|9.8||||0.509|TWO_SIDED|95.0|-19.41|39.01|||Mixed models repeated measures analysis|||Week 24||39.01|-19.41|0.509
72381698|NCT04105543|144271917|OTHER|nonparametric rank test|Median Difference (Final Values)|3.5||||0.138|TWO_SIDED|95.0|-2.0|9.5|||Wilcoxon Signed Rank Test|||Wilcoxon Signed Rank Tests for XeQOL Baseline to 3 months (n=9)||9.5|-2|0.138
72381699|NCT04105543|144271917|OTHER|nonparametric rank test|Median Difference (Final Values)|6.0||||0.225|TWO_SIDED|95.0|-10.0|16.0|||Wilcoxon Signed Rank Test|||Wilcoxon Signed Rank Test for XeQOL Baseline to 6 months (n=5)||16|-10|0.225
72381700|NCT04105543|144271918|OTHER|nonparametric rank test|Median Difference (Final Values)|0.5||||0.674|TWO_SIDED|95.0|-3.0|5.0|||Wilcoxon Signed Rank Test|||Wilcoxon Signed Rank Tests for Xerostomia Inventory Baseline to 3 months (n=9)||5|-3|0.674
72556750|NCT01592240|144644590|SUPERIORITY_OR_OTHER||Adjusted mean difference|-2.69||||0.855|TWO_SIDED|95.0|-31.76|26.38|||Mixed models repeated measures analysis|||Week 24||26.38|-31.76|0.855
72556751|NCT01592240|144644590|SUPERIORITY_OR_OTHER||Adjusted mean difference|3.04||||0.839|TWO_SIDED|95.0|-26.39|32.47|||Mixed models repeated measures analysis|||Week 24||32.47|-26.39|0.839
72556752|NCT01592240|144644590|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.99||||0.392|TWO_SIDED|95.0|-6.57|2.59|||Mixed models repeated measures analysis|||Week 24||2.59|-6.57|0.392
72556753|NCT01592240|144644590|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.33||||0.565|TWO_SIDED|95.0|-5.91|3.24|||Mixed models repeated measures analysis|||Week 24||3.24|-5.91|0.565
72556754|NCT01592240|144644604|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|14.964|||<|0.001|TWO_SIDED|95.0|3.997|56.02|||Regression, Logistic|||Week 12, Less than 100 mg/dL||56.020|3.997|<0.001
72556755|NCT01592240|144644604|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|49.615|||<|0.001|TWO_SIDED|95.0|7.984|308.328|||Regression, Logistic|||Week 12, Less than 100 mg/dL||308.328|7.984|<0.001
72556756|NCT01592240|144644604|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|12.842|||<|0.001|TWO_SIDED|95.0|3.674|44.892|||Regression, Logistic|||Week 12, Less than 100 mg/dL||44.892|3.674|<0.001
72556757|NCT01592240|144644604|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.107||||0.01|TWO_SIDED|95.0|1.304|7.401|||Regression, Logistic|||Week 12, Less than 100 mg/dL||7.401|1.304|0.010
72556758|NCT01592240|144644604|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.048|||<|0.001|TWO_SIDED|95.0|2.402|15.225|||Regression, Logistic|||Week 12, Less than 100 mg/dL||15.225|2.402|<0.001
72556759|NCT01592240|144644604|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|12.773|||<|0.001|TWO_SIDED|95.0|3.932|41.495|||Regression, Logistic|||Week 24, Less than 100 mg/dL||41.495|3.932|<0.001
72556760|NCT01592240|144644604|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|36.886|||<|0.001|TWO_SIDED|95.0|8.33|163.335|||Regression, Logistic|||Week 24, Less than 100 mg/dL||163.335|8.330|<0.001
72556761|NCT01592240|144644604|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|20.75|||<|0.001|TWO_SIDED|95.0|5.741|75.006|||Regression, Logistic|||Week 24, Less than 100 mg/dL||75.006|5.741|<0.001
72556762|NCT01592240|144644604|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.219||||0.001|TWO_SIDED|95.0|2.061|18.764|||Regression, Logistic|||Week 24, Less than 100 mg/dL||18.764|2.061|0.001
72556763|NCT01592240|144644604|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.205||||0.001|TWO_SIDED|95.0|2.06|18.693|||Regression, Logistic|||Week 24, Less than 100 mg/dL||18.693|2.060|0.001
72556764|NCT01592240|144644604|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|27.703|||<|0.001|TWO_SIDED|95.0|5.752|133.423|||Regression, Logistic|||Week 12, Less than 70 mg/dL||133.423|5.752|<0.001
72556765|NCT01592240|144644604|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|71.177|||<|0.001|TWO_SIDED|95.0|13.783|367.564|||Regression, Logistic|||Week 12, Less than 70 mg/dL||367.564|13.783|<0.001
72556766|NCT01592240|144644604|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|100.667|||<|0.001|TWO_SIDED|95.0|19.855|510.387|||Regression, Logistic|||Week 12, Less than 70 mg/dL||510.387|19.855|<0.001
72556767|NCT01592240|144644604|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Regression, Logistic|||Week 12, Less than 70 mg/dL.||||<0.001
72556768|NCT01592240|144644604|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|24.941|||<|0.001|TWO_SIDED|95.0|6.336|98.169|||Regression, Logistic|||Week 24, Less than 70 mg/dL.||98.169|6.336|<0.001
72556769|NCT01592240|144644604|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|80.004|||<|0.001|TWO_SIDED|95.0|18.094|353.742|||Regression, Logistic|||Week 24, Less than 70 mg/dL.||353.742|18.094|<0.001
72556770|NCT01592240|144644604|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|42.101|||<|0.001|TWO_SIDED|95.0|10.621|166.894|||Regression, Logistic|||Week 24, Less than 70 mg/dL.||166.894|10.621|<0.001
72556771|NCT01592240|144644604|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|11.7||||0.023|TWO_SIDED|95.0|1.396|98.075|||Regression, Logistic|||Week 24, Less than 70 mg/dL.||98.075|1.396|0.023
72556772|NCT01592240|144644604|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|36.841|||<|0.001|TWO_SIDED|95.0|4.527|299.817|||Regression, Logistic|||Week 24, Less than 70 mg/dL||299.817|4.527|<0.001
72556773|NCT01592240|144644604|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Regression, Logistic|||Week 12, Less than 40 mg/dL.||||<0.001
72556774|NCT01592240|144644604|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Regression, Logistic|||Week 12, Less than 40 mg/dL.||||<0.001
72618638|NCT01026038|144768106|SUPERIORITY_OR_OTHER||GMC ratio|1.33|||||TWO_SIDED|95.0|0.91|1.94||||||Serotype 19A: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.94|0.91|
72434187|NCT01018511|144381838|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.23||0.215|TWO_SIDED|95.0|-0.8|0.2||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.||0.2|-0.8|0.215
72381701|NCT04105543|144271918|OTHER|nonparametric rank test|Median Difference (Final Values)|0.0||||0.892|TWO_SIDED|95.0|-6.0|6.0|||Wilcoxon Signed Rank Test|||Wilcoxon Signed Rank Test for Xerostomia Inventory Baseline to 6 months (n=5)||6|-6|0.892
72381702|NCT01083485|144271990|NON_INFERIORITY_OR_EQUIVALENCE|Previously provided|Mean Difference (Final Values)|-0.1|||||TWO_SIDED|95.0|-0.5|0.3||A P value was not part of the analysis plan. A within SD 1.7, and expected treatment difference of 0 and a non-inferiority margin was -1.0 meaning that OXN PR can be one unit inferior to OXY PR and still be considered non-inferior.|ANCOVA|The primary efficacy endpoint was analysed on the PP data using a mixed-model repeat measure analysis of covariance RMANCOVA.||The sample size was calculated for a significance level of 2.5% (1 sided) with 90% power. A within SD 1.7, and expected treatment difference of 0 and a non-inferiority margin of 1.0 were assumed.||0.3|-0.5|
72381703|NCT02791399|144271992|EQUIVALENCE|Our analysis examined the estimated averages for each group at each time point after accounting for covariates.|Mean Difference (Final Values)|-1.12|||<|0.05|TWO_SIDED|95.0|-2.45|0.2|||Mixed Models Analysis|Models controlled for age, gender, depression severity, pain intensity, clinician type, and proportion of clinician panel prescribed opioids.||||0.20|-2.45|<0.05
72381704|NCT02791399|144271993|EQUIVALENCE|Our analysis examined the estimated probabilities for each group at each time point after accounting for covariates.|Mean Difference (Final Values)|-0.04|||<|0.05|TWO_SIDED|95.0|-0.15|0.06|||Mixed Models Analysis|Models controlled for age, gender, depression severity, pain intensity, clinician type, and proportion of clinician panel prescribed opioids.||||0.06|-0.15|<0.05
72381705|NCT02791399|144271994|NON_INFERIORITY|Pain intensity and pain-related function were tested in non-inferiority analyses, as we hypothesized that the ISOT intervention would not negatively impact pain or function. One-half SD difference in change was considered the appropriate non-inferiority limit.|Non-inferiority analysis|1.6|||||TWO_SIDED|||||||||||||
72556775|NCT01592240|144644604|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Regression, Logistic|||Week 12, Less than 40 mg/dL.||||<0.001
72556776|NCT01592240|144644604|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Regression, Logistic|||Week 24, Less than 40 mg/dL.||||<0.001
72556777|NCT01592240|144644604|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Regression, Logistic|||Week 24, Less than 40 mg/dL.||||<0.001
72556778|NCT01592240|144644604|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Regression, Logistic|||Week 24, Less than 40 mg/dL.||||<0.001
72556779|NCT01592240|144644604|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Regression, Logistic|||Week 12, Less than 25 mg/dL.||||<0.001
72556780|NCT01592240|144644604|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Regression, Logistic|||Week 12, Less than 25 mg/dL.||||<0.001
72556781|NCT01592240|144644604|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Regression, Logistic|||Week 12, Less than 25 mg/dL.||||<0.001
72556782|NCT01592240|144644604|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.587||||1|||||||Regression, Logistic|||Week 24, Less than 25 mg/dL||||1.000
72556783|NCT01592240|144644604|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Regression, Logistic|||Week 24, Less than 25 mg/dL.||||<0.001
72556784|NCT01592240|144644604|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.925||||1|||||||Regression, Logistic|||Week 24, Less than 25 mg/dL||||1.000
72556785|NCT01011413|144644617|NON_INFERIORITY|"Only the primary endpoint is assessed in terms of non-inferiority. All other comparisons are tests for superiority and are considered statistically significant at a two-sided alpha=0.05.~Non-inferiority of EFV 400 mg was defined as the lower 95% confidence interval (CI) of the difference between groups in the proportion of viral load below 200 copies/mL at week 48 lying above -10%."||||||0.05||||||No adjustments were made for multiple comparisons|Pearson's chi-squared|Pearson's chi-squared or Fisher's exact test derived p value was used||Sample size calculation assumes 85% of participants randomised to 600mg EFV arm will have plasma HIV RNA \<200 copies/ml at 48 weeks. Assuming no difference between randomised treatments in proportion with plasma HIV RNA \<200 copies/mL, to have 90% power to demonstrate non-inferiority in the intention to treat (ITT) analysis using a 10% non-inferiority margin will require 286 participants per arm, making a total of 572 participants. Power for modified ITT analysis was 93%.||||0.05
72618639|NCT01026038|144768106|SUPERIORITY_OR_OTHER||GMC ratio|0.73|||||TWO_SIDED|95.0|0.47|1.13||||||Serotype 19A: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.13|0.47|
72556786|NCT01011413|144644617|NON_INFERIORITY|Non-inferiority will be defined as the lower 95% confidence limit of the difference in percentages of patients with undetectable viral load lying above -10% (i.e. a non-inferiority margin of 10%).||||||0.05||||||No adjustment for multiple comparisons|Chi-squared|||To ensure the per protocol (PP) analysis has 90% power to demonstrate non-inferiority, the sample size was inflated for patients who switch treatment for toxicity. This is estimated to be no more than 10% randomised patients. To ensure 90% power to demonstrate non-inferiority in the ITT and PP analyses, a total of 630 (315 per arm) patients will be randomised giving 93% power for the ITT analysis. Null hypothesis: no statistically significant difference between the 600mg and 400mg EFV regimens.||||0.05
72556787|NCT01011413|144644618|SUPERIORITY_OR_OTHER_LEGACY||difference between proportions|0.05||||0.05|TWO_SIDED|95.0||||P-value not adjusted for multiple comparisons|Chi-squared|||||||0.05
72556788|NCT03206749|144644678|SUPERIORITY||Least Squares (LS) Mean Difference|29.5|||<|0.0001|TWO_SIDED|95.0|16.61|42.4|||ANCOVA|||||42.40|16.61|<0.0001
72556789|NCT03206749|144644679|SUPERIORITY||LS Mean Difference|28.53|||<|0.0001|TWO_SIDED|95.0|16.18|40.88|||ANCOVA|||||40.88|16.18|<0.0001
72556790|NCT03206749|144644680|SUPERIORITY||LS Mean Difference|62.79|||<|0.0001|TWO_SIDED|95.0|36.3|89.27|||ANCOVA|||||89.27|36.30|<0.0001
72381706|NCT02791399|144271995|EQUIVALENCE|This analysis is comparing estimated averages and probabilities for each group at each time point after accounting for covariates.|Mean Difference (Final Values)|-1.99|||<|0.05|TWO_SIDED|95.0|-5.83|1.85|||Mixed Models Analysis|Models controlled for age, gender, depression severity, pain intensity, clinician type, and proportion of clinician panel prescribed opioids.||||1.85|-5.83|<0.05
72381707|NCT02791399|144271996|EQUIVALENCE|Our analysis examined the estimated averages for each group at each time point after accounting for covariates.|Mean Difference (Final Values)|1.03|||<|0.05|TWO_SIDED|95.0|-6.73|8.8|||Mixed Models Analysis|Models controlled for age, gender, depression severity, pain intensity, clinician type, and proportion of clinician panel prescribed opioids.||||8.80|-6.73|<0.05
72381708|NCT03607422|144271997|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 30 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|59.6|||<|0.001|TWO_SIDED|95.0|53.1|66.2|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||66.2|53.1|<0.001
72381709|NCT03607422|144271997|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 15 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|46.9|||<|0.001|TWO_SIDED|95.0|39.9|53.9|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||53.9|39.9|<0.001
72381710|NCT03607422|144271998|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 30 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|47.4|||<|0.001|TWO_SIDED|95.0|41.0|53.7|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||53.7|41.0|<0.001
72381711|NCT03607422|144271998|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 15 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|34.0|||<|0.001|TWO_SIDED|95.0|27.8|40.2|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||40.2|27.8|<0.001
72381712|NCT03607422|144271999|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 30 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|50.4|||<|0.001|TWO_SIDED|95.0|43.8|57.1|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||57.1|43.8|<0.001
72381713|NCT03607422|144271999|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 15 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|32.6|||<|0.001|TWO_SIDED|95.0|25.8|39.4|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||39.4|25.8|<0.001
72556791|NCT03206749|144644681|SUPERIORITY||Hazard Ratio (HR)|1.47||||0.0469|TWO_SIDED|95.0|1.01|2.16|||Regression, Cox|||||2.16|1.01|0.0469
72556792|NCT03206749|144644682|SUPERIORITY||Hazard Ratio (HR)|1.26||||0.3294|TWO_SIDED|95.0|0.79|2.0|||Regression, Cox|||||2.00|0.79|0.3294
72556793|NCT03206749|144644683|SUPERIORITY|||||||0.2341|||||||Regression, Cox|||||||0.2341
72556794|NCT03206749|144644684|SUPERIORITY|||||||0.3358||||||0 - 24 hours|Cochran-Mantel-Haenszel|||||||0.3358
72556795|NCT03206749|144644684|SUPERIORITY|||||||0.0849||||||Greater than (\>) 24 - 48 hours|Cochran-Mantel-Haenszel|||||||0.0849
72556796|NCT03206749|144644685|SUPERIORITY|||||||0.0004||||||0 - 24 hours|Wilcoxon rank-sum test|||||||0.0004
72556797|NCT03206749|144644685|SUPERIORITY|||||||0.0035||||||\>24 - 48 hours|Wilcoxon rank-sum test|||||||0.0035
72556798|NCT05523895|144644708|SUPERIORITY||Mean Difference (Final Values)|-1.6|STANDARD_ERROR_OF_MEAN|1.52||0.2986|TWO_SIDED|95.0|-4.6|1.4|||Mixed Models Analysis|||||1.4|-4.6|0.2986
72556799|NCT05523895|144644708|SUPERIORITY||Mean Difference (Final Values)|-1.6|STANDARD_ERROR_OF_MEAN|1.49||0.2859|TWO_SIDED|95.0|-4.5|1.3|||Mixed Models Analysis|||||1.3|-4.5|0.2859
72556800|NCT03779334|144644730|SUPERIORITY||||||<|0.0001|||||||Exact Binomial Test|Performance Criterion = 5%||||||<0.0001
72556801|NCT01175135|144644758|OTHER||Least Squares (LS) Mean Difference|-2.21|STANDARD_ERROR_OF_MEAN|2.683||0.2053|TWO_SIDED|80.0|-5.66|1.24||Reported p-value was 1-sided.|Mixed Models Analysis|||Mixed effect repeated measures (MMRM) model with fixed effect for baseline PANSS total score, investigator site, treatment, visit, treatment by visit interaction and baseline PANSS total score by visit interaction, and random effect for participant. The model was fit using an unstructured covariance matrix.||1.24|-5.66|0.2053
72556802|NCT01175135|144644758|OTHER||LS Mean Difference|-0.67|STANDARD_ERROR_OF_MEAN|2.698||0.4024|TWO_SIDED|80.0|-4.14|2.8||Reported p-value was 1-sided.|Mixed Models Analysis|||MMRM model with fixed effect for baseline PANSS total score, investigator site, treatment, visit, treatment by visit interaction and baseline PANSS total score by visit interaction, and random effect for participant. The model was fit using an unstructured covariance matrix.||2.80|-4.14|0.4024
72556803|NCT01175135|144644758|OTHER||LS Mean Difference|-8.24|STANDARD_ERROR_OF_MEAN|3.453||0.009|TWO_SIDED|80.0|-12.68|-3.8||Reported p-value was 1-sided.|Mixed Models Analysis|||MMRM model with fixed effect for baseline PANSS total score, investigator site, treatment, visit, treatment by visit interaction and baseline PANSS total score by visit interaction, and random effect for participant. The model was fit using an unstructured covariance matrix.||-3.80|-12.68|0.0090
72556804|NCT01175135|144644759|OTHER||Difference in Proportion|-0.03|||||TWO_SIDED|80.0|-0.07|0.01|||||The adjusted 80% Confidence Interval (CI) equals 88.6% CI, adjusted due to 1 interim look.|||0.01|-0.07|
72556805|NCT01175135|144644759|OTHER||Difference in Proportion|0.04|||||TWO_SIDED|80.0|-0.02|0.1|||||The adjusted 80% CI equals 88.6% CI, adjusted due to 1 interim look.|||0.10|-0.02|
72556806|NCT01175135|144644759|OTHER||Difference in Proportion|-0.04|||||TWO_SIDED|80.0|-0.08|0.0|||||The adjusted 80% CI equals 88.6% CI, adjusted due to 1 interim look.|||-0.00|-0.08|
72556807|NCT01175135|144644760|OTHER||LS Mean Difference|-0.41|STANDARD_ERROR_OF_MEAN|0.845||0.3144|TWO_SIDED|80.0|-1.5|0.68||Reported p-value was 1-sided.|Mixed Models Analysis|||Positive Score: MMRM model with fixed effect for baseline PANSS positive subscale score, investigator site, treatment, visit, a treatment by visit interaction and a baseline PANSS positive subscale score by visit interaction and a random effect for participant. The model was fit using an unstructured covariance matrix.||0.68|-1.50|0.3144
72556808|NCT01175135|144644760|OTHER||LS Mean Difference|0.15|STANDARD_ERROR_OF_MEAN|0.854||0.57|TWO_SIDED|80.0|-0.95|1.25||Reported p-value was 1-sided.|Mixed Models Analysis|||Positive Score: MMRM model with fixed effect for baseline PANSS positive subscale score, investigator site, treatment, visit, a treatment by visit interaction and a baseline PANSS positive subscale score by visit interaction and a random effect for participant. The model was fit using an unstructured covariance matrix.||1.25|-0.95|0.5700
72556809|NCT01175135|144644760|OTHER||LS Mean Difference|-2.99|STANDARD_ERROR_OF_MEAN|1.093||0.0034|TWO_SIDED|80.0|-4.4|-1.59||Reported p-value was 1-sided.|Mixed Models Analysis|||Positive Score: MMRM model with fixed effect for baseline PANSS positive subscale score, investigator site, treatment, visit, a treatment by visit interaction and a baseline PANSS positive subscale score by visit interaction and a random effect for participant. The model was fit using an unstructured covariance matrix.||-1.59|-4.40|0.0034
72556810|NCT01175135|144644760|OTHER||LS Mean Difference|-0.96|STANDARD_ERROR_OF_MEAN|0.73||0.0942|TWO_SIDED|80.0|-1.9|-0.02||Reported p-value was 1-sided.|Mixed Models Analysis|||Negative Score: MMRM model with fixed effect for baseline PANSS negative subscale score, investigator site, treatment, visit, a treatment by visit interaction and a baseline PANSS negative subscale score by visit interaction and a random effect for participant. The model was fit using an unstructured covariance matrix.||-0.02|-1.90|0.0942
72556811|NCT01175135|144644760|OTHER||LS Mean Difference|-0.61|STANDARD_ERROR_OF_MEAN|0.735||0.203|TWO_SIDED|80.0|-1.56|0.33||Reported p-value was 1-sided.|Mixed Models Analysis|||Negative Score: MMRM model with fixed effect for baseline PANSS negative subscale score, investigator site, treatment, visit, a treatment by visit interaction and a baseline PANSS negative subscale score by visit interaction and a random effect for participant. The model was fit using an unstructured covariance matrix.||0.33|-1.56|0.2030
72556812|NCT01175135|144644760|OTHER||LS Mean Difference|-1.26|STANDARD_ERROR_OF_MEAN|0.944||0.0907|TWO_SIDED|80.0|-2.48|-0.05||Reported p-value was 1-sided.|Mixed Models Analysis|||Negative Score: MMRM model with fixed effect for baseline PANSS negative subscale score, investigator site, treatment, visit, a treatment by visit interaction and a baseline PANSS negative subscale score by visit interaction and a random effect for participant. The model was fit using an unstructured covariance matrix.||-0.05|-2.48|0.0907
72381714|NCT03607422|144272000|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 30 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|53.1|||<|0.001|TWO_SIDED|95.0|46.7|59.4|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||59.4|46.7|<0.001
72434188|NCT01018511|144381839|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.08||0.383|TWO_SIDED|95.0|-0.2|0.1||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate||Mean change vs TOCAS.||0.1|-0.2|0.383
72434189|NCT01018511|144381839|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|0.1|STANDARD_ERROR_OF_MEAN|0.08||0.402|TWO_SIDED|95.0|-0.1|0.2||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs TOCAS.||0.2|-0.1|0.402
72434190|NCT01018511|144381839|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.08||0.021|TWO_SIDED|95.0|-0.3|0.0||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.||-0.0|-0.3|0.021
72618640|NCT01026038|144768107|SUPERIORITY_OR_OTHER||GMC ratio|0.63|||||TWO_SIDED|95.0|0.23|1.76||||||Serotype 4: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||1.76|0.23|
72381715|NCT03607422|144272000|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 15 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|36.9|||<|0.001|TWO_SIDED|95.0|30.6|43.3|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||43.3|30.6|<0.001
72381716|NCT03607422|144272001|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 30 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|57.0|||<|0.001|TWO_SIDED|95.0|50.9|63.0|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||63.0|50.9|<0.001
72381717|NCT03607422|144272001|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 15 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|45.2|||<|0.001|TWO_SIDED|95.0|38.9|51.4|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||51.4|38.9|<0.001
72381718|NCT03607422|144272002|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 30 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|40.4|||<|0.001|TWO_SIDED|95.0|34.2|46.5|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||46.5|34.2|<0.001
72381719|NCT03607422|144272002|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 15 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|29.4|||<|0.001|TWO_SIDED|95.0|23.5|35.3|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||35.3|23.5|<0.001
72381720|NCT03607422|144272003|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 30 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|14.9|||<|0.001|TWO_SIDED|95.0|10.6|19.3|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||19.3|10.6|<0.001
72381721|NCT03607422|144272003|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 15 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|6.7|||<|0.001|TWO_SIDED|95.0|3.4|10.0|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||10.0|3.4|<0.001
72381722|NCT03607422|144272004|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 30 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|7.2|||<|0.001|TWO_SIDED|95.0|3.8|10.5|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||10.5|3.8|<0.001
72381723|NCT03607422|144272005|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 15 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|8.6|||<|0.001|TWO_SIDED|95.0|4.3|12.9|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||12.9|4.3|<0.001
72434191|NCT01018511|144381839|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.08||0.584|TWO_SIDED|95.0|-0.2|0.1||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.||0.1|-0.2|0.584
72434192|NCT01018511|144381839|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.08||0.166|TWO_SIDED|95.0|-0.3|0.0||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.||0.0|-0.3|0.166
72504713|NCT01954628|144540212|SUPERIORITY_OR_OTHER||Least sqaure mean difference|1.083||||0.646|TWO_SIDED|95.0|0.771|1.52|||Negative binomial regression model|Negative binomial regression model with fixed factors treatment, region and time in study as offset.||The number of subjects with at least one COPD exacerbation were summarised by treatment group.||1.520|0.771|0.646
72504714|NCT01954628|144540215|SUPERIORITY_OR_OTHER|||||||0.226|||||||ANOVA|||Missing post-treatment data was imputed using the Last Observation Carried Forward principle.||||0.226
72556813|NCT01175135|144644760|OTHER||LS Mean Difference|-0.74|STANDARD_ERROR_OF_MEAN|1.33||0.2904|TWO_SIDED|80.0|-2.45|0.97||Reported p-value was 1-sided.|Mixed Models Analysis|||General Score: MMRM model with fixed effect for baseline PANSS general subscale score, investigator site, treatment, visit, a treatment by visit interaction and a baseline PANSS general subscale score by visit interaction and a random effect for participant. The model was fit using an unstructured covariance matrix.||0.97|-2.45|0.2904
72381724|NCT03607422|144272006|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 30 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|-23.1|||<|0.001|TWO_SIDED|95.0|-28.4|-17.8|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||-17.8|-28.4|<0.001
72381725|NCT03607422|144272006|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 15 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|-22.4|||<|0.001|TWO_SIDED|95.0|-27.8|-16.9|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||-16.9|-27.8|<0.001
72381726|NCT03607422|144272007|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 30 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|49.8|||<|0.001|TWO_SIDED|95.0|42.2|57.3|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||57.3|42.2|<0.001
72381727|NCT03607422|144272007|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 15 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|37.9|||<|0.001|TWO_SIDED|95.0|30.1|45.8|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||45.8|30.1|<0.001
72381728|NCT03607422|144272008|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 30 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|51.8|||<|0.001|TWO_SIDED|95.0|44.4|59.1|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||59.1|44.4|<0.001
72381729|NCT03607422|144272008|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 15 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|35.9|||<|0.001|TWO_SIDED|95.0|28.2|43.5|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||43.5|28.2|<0.001
72381730|NCT03607422|144272009|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 30 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|53.3|||<|0.001|TWO_SIDED|95.0|46.0|60.6|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||60.6|46.0|<0.001
72381731|NCT03607422|144272009|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 15 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|40.3|||<|0.001|TWO_SIDED|95.0|32.7|48.0|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||48.0|32.7|<0.001
72381732|NCT03607422|144272010|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 30 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|54.8|||<|0.001|TWO_SIDED|95.0|47.2|62.3|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||62.3|47.2|<0.001
72381733|NCT03607422|144272010|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 15 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|40.3|||<|0.001|TWO_SIDED|95.0|32.3|48.3|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||48.3|32.3|<0.001
72434193|NCT01018511|144381840|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.3||0.187|TWO_SIDED|95.0|-1.0|0.2||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs TOCAS.||0.2|-1.0|0.187
72434194|NCT01018511|144381840|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.31||0.203|TWO_SIDED|95.0|-1.0|0.2||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs TOCAS.||0.2|-1.0|0.203
72434195|NCT01018511|144381840|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.29||0.09|TWO_SIDED|95.0|-1.1|0.1||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.||0.1|-1.1|0.090
72434196|NCT01018511|144381840|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.29||0.098|TWO_SIDED|95.0|-1.1|0.1||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.||0.1|-1.1|0.098
72434197|NCT01018511|144381840|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.31||0.772|TWO_SIDED|95.0|-0.7|0.5||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.||0.5|-0.7|0.772
72434198|NCT01018511|144381841|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.27||0.21|TWO_SIDED|95.0|-0.9|0.2||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs TOCAS.||0.2|-0.9|0.210
72434199|NCT01018511|144381841|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|0.1|STANDARD_ERROR_OF_MEAN|0.28||0.775|TWO_SIDED|95.0|-0.5|0.6||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs TOCAS.||0.6|-0.5|0.775
72434200|NCT01018511|144381841|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.7|STANDARD_ERROR_OF_MEAN|0.27||0.01|TWO_SIDED|95.0|-1.2|-0.2||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.||-0.2|-1.2|0.010
72434201|NCT01018511|144381841|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.27||0.317|TWO_SIDED|95.0|-0.8|0.3||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.||0.3|-0.8|0.317
72434202|NCT01018511|144381841|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.27||0.196|TWO_SIDED|95.0|-0.9|0.2||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.||0.2|-0.9|0.196
72434203|NCT01018511|144381842|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.2||0.009|TWO_SIDED|95.0|-0.9|-0.1||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs TOCAS.||-0.1|-0.9|0.009
72434204|NCT01018511|144381842|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.21||0.045|TWO_SIDED|95.0|-0.8|0.0||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs TOCAS.||-0.0|-0.8|0.045
72434205|NCT01018511|144381842|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-1.1|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|-1.4|-0.7||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.||-0.7|-1.4|< 0.001
72434206|NCT01018511|144381842|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.2||0.011|TWO_SIDED|95.0|-0.9|-0.1||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.||-0.1|-0.9|0.011
72434207|NCT01018511|144381842|SUPERIORITY_OR_OTHER_LEGACY||Least squares men difference|-0.9|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|-1.3|-0.5||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.||-0.5|-1.3|< 0.001
72434208|NCT01018511|144381843|SUPERIORITY_OR_OTHER_LEGACY||least squares mean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.1||0.008|TWO_SIDED|95.0|-0.5|-0.1||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs TOCAS.||-0.1|-0.5|0.008
72434209|NCT01018511|144381843|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.1||0.021|TWO_SIDED|95.0|-0.4|0.0||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs TOCAS.||-0.0|-0.4|0.021
72434210|NCT01018511|144381843|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.6|-0.2||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.||-0.2|-0.6|< 0.001
72434211|NCT01018511|144381843|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.6|-0.2||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.||-0.2|-0.6|< 0.001
72434212|NCT01018511|144381843|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.1||0.139|TWO_SIDED|95.0|-0.3|0.0||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.||0.0|-0.3|0.139
72381734|NCT03607422|144272011|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 30 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|50.6|||<|0.001|TWO_SIDED|95.0|42.8|58.5|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||58.5|42.8|<0.001
72381735|NCT03607422|144272011|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 15 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|37.9|||<|0.001|TWO_SIDED|95.0|29.5|46.3|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||46.3|29.5|<0.001
72381736|NCT03607422|144272012|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 30 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|18.1|||<|0.0001|TWO_SIDED|95.0|13.5|22.7|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||22.7|13.5|<0.0001
72381737|NCT03607422|144272012|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 15 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|13.4|||<|0.001|TWO_SIDED|95.0|9.2|17.6|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||17.6|9.2|<0.001
72381738|NCT03607422|144272013|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 30 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer. This endpoint was a multiplicity-controlled key secondary endpoint for European Union (EU)/European Medicines Agency (EMA) regulatory purposes only.|Least Squares (LS) Mean Difference|-49.45|STANDARD_ERROR_OF_MEAN|3.364|<|0.001|TWO_SIDED|95.0|-56.05|-42.84|||Mixed Effect Model Repeated Measurement|Mixed-effect model repeat measurement with Baseline, treatment, visit, treatment by visit interaction, Baseline vIGA-AD category and age in the model.|Difference = Upadacitinib - Placebo|||-42.84|-56.05|<0.001
72381739|NCT03607422|144272013|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 15 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer. This endpoint was a multiplicity-controlled key secondary endpoint for EU/EMA regulatory purposes only.|LS Mean Difference|-34.16|STANDARD_ERROR_OF_MEAN|3.386|<|0.001|TWO_SIDED|95.0|-40.81|-27.51|||Mixed Effect Model Repeated Measurement|Mixed-effect model repeat measurement with Baseline, treatment, visit, treatment by visit interaction, Baseline vIGA-AD category and age in the model.|Difference = Upadacitinib - Placebo|||-27.51|-40.81|<0.001
72381740|NCT03607422|144272014|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 30 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer. This endpoint was a multiplicity-controlled key secondary endpoint for EU/EMA regulatory purposes only.|LS Mean Difference|-50.14|STANDARD_ERROR_OF_MEAN|3.127|<|0.001|TWO_SIDED|95.0|-56.28|-44.0|||Mixed Effect Model Repeated Measurement|Mixed-effect model repeat measurement with Baseline, treatment, visit, treatment by visit interaction, Baseline vIGA-AD category and age in the model.|Difference = Upadacitinib - Placebo|||-44.00|-56.28|<0.001
72381741|NCT03607422|144272014|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 15 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer. This endpoint was a multiplicity-controlled key secondary endpoint for EU/EMA regulatory purposes only.|LS Mean Difference|-39.62|STANDARD_ERROR_OF_MEAN|3.139|<|0.001|TWO_SIDED|95.0|-45.79|-33.46|||Mixed Effect Model Repeated Measurement|Mixed-effect model repeat measurement with Baseline, treatment, visit, treatment by visit interaction, Baseline vIGA-AD category and age in the model.|Difference = Upadacitinib - Placebo|||-33.46|-45.79|<0.001
72434213|NCT01018511|144381845|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-2.1|STANDARD_ERROR_OF_MEAN|1.14||0.068|TWO_SIDED|95.0|-4.3|0.2||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs TOCAS.||0.2|-4.3|0.068
72434214|NCT01018511|144381845|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-2.7|STANDARD_DEVIATION|1.15||0.02|TWO_SIDED|95.0|-4.9|-0.4||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs TOCAS.||-0.4|-4.9|0.020
72434215|NCT01018511|144381845|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-4.7|STANDARD_ERROR_OF_MEAN|1.12|<|0.001|TWO_SIDED|95.0|-6.9|-2.5||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.||-2.5|-6.9|< 0.001
72434216|NCT01018511|144381845|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-5.3|STANDARD_ERROR_OF_MEAN|1.13|<|0.001|TWO_SIDED|95.0|-7.5|-3.1||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate||Mean change vs placebo.||-3.1|-7.5|< 0.001
72434217|NCT01018511|144381845|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-2.6|STANDARD_ERROR_OF_MEAN|1.14||0.022|TWO_SIDED|95.0|-4.8|0.4||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.||0.4|-4.8|0.022
72434218|NCT01018511|144381846|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|3.0|STANDARD_ERROR_OF_MEAN|1.16||0.011|TWO_SIDED|95.0|0.7|5.2||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate||Mean change vs TOCAS.||5.2|0.7|0.011
72434219|NCT01018511|144381846|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|2.5|STANDARD_ERROR_OF_MEAN|1.17||0.035|TWO_SIDED|95.0|0.2|4.8||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs TOCAS.||4.8|0.2|0.035
72434220|NCT01018511|144381846|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|5.1|STANDARD_ERROR_OF_MEAN|1.14|<|0.001|TWO_SIDED|95.0|2.8|7.3||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.||7.3|2.8|< 0.001
72434221|NCT01018511|144381846|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|4.6|STANDARD_ERROR_OF_MEAN|1.15|<|0.001|TWO_SIDED|95.0|2.3|6.8||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.||6.8|2.3|< 0.001
72434222|NCT01018511|144381846|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|2.1|STANDARD_ERROR_OF_MEAN|1.16||0.068|TWO_SIDED|95.0|-0.2|4.4||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.||4.4|-0.2|0.068
72434223|NCT01018511|144381847|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|2.6|STANDARD_ERROR_OF_MEAN|1.07||0.013|TWO_SIDED|95.0|0.5|4.7||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs TOCAS.||4.7|0.5|0.013
72434224|NCT01018511|144381847|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|2.2|STANDARD_ERROR_OF_MEAN|1.08||0.043|TWO_SIDED|95.0|0.1|4.3||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs TOCAS.||4.3|0.1|0.043
72434225|NCT01018511|144381847|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|4.4|STANDARD_ERROR_OF_MEAN|1.05|<|0.001|TWO_SIDED|95.0|2.4|6.5||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.||6.5|2.4|< 0.001
72434226|NCT01018511|144381847|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|4.0|STANDARD_ERROR_OF_MEAN|1.06|<|0.001|TWO_SIDED|95.0|1.9|6.1||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.||6.1|1.9|< 0.001
72434227|NCT01018511|144381847|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|1.8|STANDARD_ERROR_OF_MEAN|1.06||0.092|TWO_SIDED|95.0|-0.3|3.9||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.||3.9|-0.3|0.092
72434228|NCT01018511|144381848|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|3.1|STANDARD_ERROR_OF_MEAN|1.21||0.011|TWO_SIDED|95.0|0.7|5.5||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs TOCAS.||5.5|0.7|0.011
72434229|NCT01018511|144381848|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|1.2|STANDARD_ERROR_OF_MEAN|1.23||0.314|TWO_SIDED|95.0|-1.2|3.6||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs TOCAS.||3.6|-1.2|0.314
72434230|NCT01018511|144381848|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|3.6|STANDARD_ERROR_OF_MEAN|1.19||0.003|TWO_SIDED|95.0|1.2|5.9||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.||5.9|1.2|0.003
72434231|NCT01018511|144381848|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|1.7|STANDARD_ERROR_OF_MEAN|1.21||0.161|TWO_SIDED|95.0|-0.7|4.1||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.||4.1|-0.7|0.161
72381742|NCT03607422|144272015|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 30 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer. This endpoint was a multiplicity-controlled key secondary endpoint for EU/EMA regulatory purposes only.|Adjusted Response Rate Difference|54.7|||<|0.001|TWO_SIDED|95.0|47.7|61.7|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||61.7|47.7|<0.001
72434232|NCT01018511|144381848|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|0.5|STANDARD_ERROR_OF_MEAN|1.21||0.708|TWO_SIDED|95.0|-1.9|2.8||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.||2.8|-1.9|0.708
72618641|NCT01026038|144768107|SUPERIORITY_OR_OTHER||GMC Ratio|0.77|||||TWO_SIDED|95.0|0.3|1.99||||||Serotype 4: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.99|0.30|
72556814|NCT01175135|144644760|OTHER||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|1.339||0.471|TWO_SIDED|80.0|-1.82|1.62||Reported p-value was 1-sided.|Mixed Models Analysis|||General Score: MMRM model with fixed effect for baseline PANSS general subscale score, investigator site, treatment, visit, a treatment by visit interaction and a baseline PANSS general subscale score by visit interaction and a random effect for participant. The model was fit using an unstructured covariance matrix.||1.62|-1.82|0.4710
72556815|NCT01175135|144644760|OTHER||LS Mean Difference|-3.66|STANDARD_ERROR_OF_MEAN|1.718||0.0172|TWO_SIDED|80.0|-5.86|-1.45||Reported p-value was 1-sided.|Mixed Models Analysis|||General Score: MMRM model with fixed effect for baseline PANSS general subscale score, investigator site, treatment, visit, a treatment by visit interaction and a baseline PANSS general subscale score by visit interaction and a random effect for participant. The model was fit using an unstructured covariance matrix.||-1.45|-5.86|0.0172
72556816|NCT01175135|144644761|OTHER||LS Mean Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.154||0.197|TWO_SIDED|80.0|-0.33|0.07||Reported p-value was 1-sided.|Mixed Models Analysis|||MMRM model with fixed effect for baseline CGI-S, investigator site, treatment, visit, treatment by visit interaction, a baseline CGI-S by visit interaction and random effect for participant. The model was fit using an unstructured covariance matrix.||0.07|-0.33|0.1970
72556817|NCT01175135|144644761|OTHER||LS Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.154||0.3835|TWO_SIDED|80.0|-0.24|0.15||Reported p-value was 1-sided.|Mixed Models Analysis|||MMRM model with fixed effect for baseline CGI-S, investigator site, treatment, visit, treatment by visit interaction, a baseline CGI-S by visit interaction and random effect for participant. The model was fit using an unstructured covariance matrix.||0.15|-0.24|0.3835
72556818|NCT01175135|144644761|OTHER||LS Mean Difference|-0.35|STANDARD_ERROR_OF_MEAN|0.199||0.0395|TWO_SIDED|80.0|-0.61|-0.1||Reported p-value was 1-sided.|Mixed Models Analysis|||MMRM model with fixed effect for baseline CGI-S, investigator site, treatment, visit, treatment by visit interaction, a baseline CGI-S by visit interaction and random effect for participant. The model was fit using an unstructured covariance matrix.||-0.10|-0.61|0.0395
72556819|NCT01175135|144644762|OTHER||LS Mean Difference|-0.73|STANDARD_ERROR_OF_MEAN|0.863||0.1999|TWO_SIDED|80.0|-1.84|0.38||Reported p-value was 1-sided.|Mixed Models Analysis|||Positive Score: MMRM model with fixed effect for baseline PANSS Marder positive score, investigator site, treatment, visit, treatment by visit interaction and baseline PANSS Marder positive score by visit interaction, and random effect for participant. The model was fit using an unstructured covariance matrix.||0.38|-1.84|0.1999
72556820|NCT01175135|144644762|OTHER||LS Mean Difference|-0.36|STANDARD_ERROR_OF_MEAN|0.87||0.3399|TWO_SIDED|80.0|-1.48|0.76||Reported p-value was 1-sided.|Mixed Models Analysis|||Positive Score: MMRM model with fixed effect for baseline PANSS Marder positive score, investigator site, treatment, visit, treatment by visit interaction and baseline PANSS Marder positive score by visit interaction, and random effect for participant. The model was fit using an unstructured covariance matrix.||0.76|-1.48|0.3399
72618642|NCT01026038|144768107|SUPERIORITY_OR_OTHER||GMC Ratio|1.21|||||TWO_SIDED|95.0|0.38|3.86||||||Serotype 4: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||3.86|0.38|
72556821|NCT01175135|144644762|OTHER||LS Mean Difference|-2.62|STANDARD_ERROR_OF_MEAN|1.117||0.01|TWO_SIDED|80.0|-4.06|-1.18||Reported p-value was 1-sided.|Mixed Models Analysis|||Positive Score: MMRM model with fixed effect for baseline PANSS Marder positive score, investigator site, treatment, visit, treatment by visit interaction and baseline PANSS Marder positive score by visit interaction, and random effect for participant. The model was fit using an unstructured covariance matrix.||-1.18|-4.06|0.0100
72381743|NCT03607422|144272015|SUPERIORITY||Adjusted Response Rate Difference|42.1|||<|0.001|TWO_SIDED|95.0|34.5|49.8|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|The overall type I error rate of the primary and secondary endpoints for upadacitinib 15 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer. This endpoint was a multiplicity-controlled key secondary endpoint for EU/EMA regulatory purposes only.||49.8|34.5|<0.001
72381744|NCT03607422|144272016|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 30 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer. This endpoint was a multiplicity-controlled key secondary endpoint for EU/EMA regulatory purposes only.|Adjusted Response Rate Difference|49.0|||<|0.001|TWO_SIDED|95.0|41.4|56.5|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||56.5|41.4|<0.001
72434233|NCT01018511|144381849|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|1.7|STANDARD_ERROR_OF_MEAN|0.83||0.043|TWO_SIDED|95.0|0.1|3.3||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs TOCAS.||3.3|0.1|0.043
72556822|NCT01175135|144644762|OTHER||LS Mean Difference|-0.77|STANDARD_ERROR_OF_MEAN|0.778||0.1625|TWO_SIDED|80.0|-1.77|0.23||Reported p-value was 1-sided.|Mixed Models Analysis|||Negative Score: MMRM model with fixed effect for baseline PANSS Marder negative score, investigator site, treatment, visit, treatment by visit interaction and baseline PANSS Marder negative score by visit interaction, and random effect for participant. The model was fit using an unstructured covariance matrix.||0.23|-1.77|0.1625
72556823|NCT01175135|144644762|OTHER||LS Mean Difference|-0.57|STANDARD_ERROR_OF_MEAN|0.783||0.2354|TWO_SIDED|80.0|-1.57|0.44||Reported p-value was 1-sided.|Mixed Models Analysis|||Negative Score: MMRM model with fixed effect for baseline PANSS Marder negative score, investigator site, treatment, visit, treatment by visit interaction and baseline PANSS Marder negative score by visit interaction, and random effect for participant. The model was fit using an unstructured covariance matrix.||0.44|-1.57|0.2354
72618643|NCT01026038|144768107|SUPERIORITY_OR_OTHER||GMC ratio|0.93|||||TWO_SIDED|95.0|0.43|1.99||||||Serotype 6B: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||1.99|0.43|
72556824|NCT01175135|144644762|OTHER||LS Mean Difference|-0.79|STANDARD_ERROR_OF_MEAN|1.002||0.2161|TWO_SIDED|80.0|-2.08|0.5||Reported p-value was 1-sided.|Mixed Models Analysis|||Negative Score: MMRM model with fixed effect for baseline PANSS Marder negative score, investigator site, treatment, visit, treatment by visit interaction and baseline PANSS Marder negative score by visit interaction, and random effect for participant. The model was fit using an unstructured covariance matrix.||0.50|-2.08|0.2161
72556825|NCT01175135|144644762|OTHER||LS Mean Difference|-0.43|STANDARD_ERROR_OF_MEAN|0.627||0.248|TWO_SIDED|80.0|-1.23|0.38||Reported p-value was 1-sided.|Mixed Models Analysis|||Disorganized Thought Score: MMRM model with fixed effect for baseline PANSS Marder disorganized thought score, investigator site, treatment, visit, treatment by visit interaction and baseline PANSS Marder disorganized thought score by visit interaction, and random effect for participant. The model was fit using an unstructured covariance matrix.||0.38|-1.23|0.2480
72556826|NCT01175135|144644762|OTHER||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.632||0.4345|TWO_SIDED|80.0|-0.92|0.71||Reported p-value was 1-sided.|Mixed Models Analysis|||Disorganized Thought Score: MMRM model with fixed effect for baseline PANSS Marder disorganized thought score, investigator site, treatment, visit, treatment by visit interaction and baseline PANSS Marder disorganized thought score by visit interaction, and random effect for participant. The model was fit using an unstructured covariance matrix.||0.71|-0.92|0.4345
72556827|NCT01175135|144644762|OTHER||LS Mean Difference|-1.48|STANDARD_ERROR_OF_MEAN|0.813||0.0346|TWO_SIDED|80.0|-2.53|-0.44||Reported p-value was 1-sided.|Mixed Models Analysis|||Disorganized Thought Score: MMRM model with fixed effect for baseline PANSS Marder disorganized thought score, investigator site, treatment, visit, treatment by visit interaction and baseline PANSS Marder disorganized thought score by visit interaction, and random effect for participant. The model was fit using an unstructured covariance matrix.||-0.44|-2.53|0.0346
72556828|NCT01175135|144644762|OTHER||LS Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.495||0.4685|TWO_SIDED|80.0|-0.68|0.6||Reported p-value was 1-sided.|Mixed Models Analysis|||Uncontrolled hostility/excitement Score: MMRM model with fixed effect for baseline PANSS Marder hostility/excitement score, investigator site, treatment, visit, treatment by visit interaction and baseline PANSS Marder hostility/excitement score by visit interaction, and random effect for participant. The model was fit using an unstructured covariance matrix.||0.60|-0.68|0.4685
72493958|NCT00493038|144516815|NON_INFERIORITY_OR_EQUIVALENCE|"The non-inferiority margin was set to 15% in the protocol. Sample size was estimated using the method as described in Farrington-Manning (STATISTICS IN MEDICINE, Vol. 9; Farrington CP, Manning G: Test statistics and sample size formulae for comparative binomial trials with null hypothesis of non-zero risk difference..., pg.1447-1454 \[1990\]). Estimation was performed to achieve 90% power, based on the equivalence delta of 15%, and a clinical success rate of 80% in the per protocol population."|Mean Difference (Final Values)|1.7||||||95.0|-3.8|7.1||||||Calculated were 95% confidence intervals for the difference in success rates between treatment groups (moxifloxacin minus comparator). Method as described in Koch et al. ('Categorical Data Analysis' in Statistical methodology in the pharmaceutical sciences / edited by D. A. Berry, p. 415 ff., Marcel Dekker, 1990)||7.1|-3.8|
72381745|NCT03607422|144272016|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 15 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer. This endpoint was a multiplicity-controlled key secondary endpoint for EU/EMA regulatory purposes only.|Adjusted Response Rate Difference|42.8||||0.002|TWO_SIDED|95.0|35.0|50.6|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||50.6|35.0|0.002
72381746|NCT03607422|144272017|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 30 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer. This endpoint was a multiplicity-controlled key secondary endpoint for EU/EMA regulatory purposes only.|LS Mean Difference|-40.01|STANDARD_ERROR_OF_MEAN|2.949|<|0.001|TWO_SIDED|95.0|-45.8|-34.22|||Mixed Effect Model Repeated Measurement|Mixed-effect model repeat measurement with Baseline, treatment, visit, treatment by visit interaction, Baseline vIGA-AD category and age in the model.|Difference = Upadacitinib - Placebo|||-34.22|-45.80|<0.001
72381747|NCT03607422|144272017|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 15 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer. This endpoint was a multiplicity-controlled key secondary endpoint for EU/EMA regulatory purposes only.|LS Mean Difference|-29.47|STANDARD_ERROR_OF_MEAN|2.941|<|0.001|TWO_SIDED|95.0|-35.24|-23.69|||Mixed Effect Model Repeated Measurement|Mixed-effect model repeat measurement with Baseline, treatment, visit, treatment by visit interaction, Baseline vIGA-AD category and age in the model.||||-23.69|-35.24|<0.001
72381748|NCT03607422|144272018|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 30 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer. This endpoint was a multiplicity-controlled key secondary endpoint for EU/EMA regulatory purposes only.|Adjusted Response Rate Difference|44.5|||<|0.001|TWO_SIDED|95.0|35.0|54.1|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||54.1|35.0|<0.001
72556829|NCT01175135|144644762|OTHER||LS Mean Difference|0.15|STANDARD_ERROR_OF_MEAN|0.499||0.6214|TWO_SIDED|80.0|-0.49|0.8||Reported p-value was 1-sided.|Mixed Models Analysis|||Uncontrolled hostility/excitement Score: MMRM model with fixed effect for baseline PANSS Marder hostility/excitement score, investigator site, treatment, visit, treatment by visit interaction and baseline PANSS Marder hostility/excitement score by visit interaction, and random effect for participant. The model was fit using an unstructured covariance matrix.||0.80|-0.49|0.6214
72618644|NCT01026038|144768107|SUPERIORITY_OR_OTHER||GMC ratio|1.09|||||TWO_SIDED|95.0|0.54|2.22||||||Serotype 6B: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||2.22|0.54|
72493959|NCT01175902|144516836|NON_INFERIORITY_OR_EQUIVALENCE|"To prove the non-inferiority of Cosopt to Xalatan, the sample size calculation was based on the assumption that non-inferiority margin of trough IOP of 1.5mmHg. A sample size of n=21 patients per group, this study has 80% power (1-β=0.80) and α=0.05, crossover-designed analysis.~In this study, the upper limit of the 95% CI is expected above the maximal acceptable clinically significant difference of 1.5 mmHg of IOP."|Mean Difference (Final Values)|0.9||||0.05|TWO_SIDED|||||Comparison between two arms were made for IOP, systolic BP, diastolic BP and OPP at each time period.|t-test, 2 sided|Comparison between two arms were made for IOP, systolic BP, diastolic BP and OPP at each time period.|Comparison between two arms were made for IOP, systolic BP, diastolic BP and OPP at each time period.|Comparison between two arms were made for IOP, systolic BP, diastolic BP and OPP at each time period.||||0.05
72381749|NCT03607422|144272018|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 15 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer. This endpoint was a multiplicity-controlled key secondary endpoint for EU/EMA regulatory purposes only.|Adjusted Response Rate Difference|34.4|||<|0.001|TWO_SIDED|95.0|24.7|44.2|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||44.2|24.7|<0.001
72381750|NCT03607422|144272019|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 30 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer. This endpoint was a multiplicity-controlled key secondary endpoint for EU/EMA regulatory purposes only.|Adjusted Response Rate Difference|33.3|||<|0.001|TWO_SIDED|95.0|26.9|39.8|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||39.8|26.9|<0.001
72381751|NCT03607422|144272019|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 15 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer. This endpoint was a multiplicity-controlled key secondary endpoint for EU/EMA regulatory purposes only.|Adjusted Response Rate Difference|19.1|||<|0.001|TWO_SIDED|95.0|13.3|24.9|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||24.9|13.3|<0.001
72434234|NCT01018511|144381849|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|1.3|STANDARD_ERROR_OF_MEAN|0.84||0.12|TWO_SIDED|95.0|-0.3|3.0||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs TOCAS.||3.0|-0.3|0.120
72381752|NCT03607422|144272020|SUPERIORITY||Adjusted Response Rate Difference|59.9|||<|0.001|TWO_SIDED|95.0|45.9|73.8|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||73.8|45.9|<0.001
72381753|NCT03607422|144272020|SUPERIORITY||Adjusted Response Rate Difference|55.8|||<|0.001|TWO_SIDED|95.0|41.1|70.4|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||70.4|41.1|<0.001
72434235|NCT01018511|144381849|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|2.4|STANDARD_ERROR_OF_MEAN|0.82||0.003|TWO_SIDED|95.0|0.8|4.0||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.||4.0|0.8|0.003
72434236|NCT01018511|144381849|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|2.0|STANDARD_ERROR_OF_MEAN|0.83||0.014|TWO_SIDED|95.0|0.4|3.7||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate||Mean change vs placebo.||3.7|0.4|0.014
72434237|NCT01018511|144381849|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|0.7|STANDARD_ERROR_OF_MEAN|0.83||0.384|TWO_SIDED|95.0|-0.9|2.4||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.||2.4|-0.9|0.384
72434238|NCT01018511|144381850|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|2.6|STANDARD_ERROR_OF_MEAN|0.92||0.004|TWO_SIDED|95.0|0.8|4.4||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs TOCAS.||4.4|0.8|0.004
72434239|NCT01018511|144381850|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|2.0|STANDARD_ERROR_OF_MEAN|0.93||0.035|TWO_SIDED|95.0|0.1|3.8||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs TOCAS.||3.8|0.1|0.035
72434240|NCT01018511|144381850|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|4.0|STANDARD_ERROR_OF_MEAN|0.91|<|0.001|TWO_SIDED|95.0|2.2|5.8||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.||5.8|2.2|< 0.001
72434241|NCT01018511|144381850|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|3.3|STANDARD_ERROR_OF_MEAN|0.92|<|0.001|TWO_SIDED|95.0|1.5|5.1||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.||5.1|1.5|< 0.001
72434242|NCT01018511|144381850|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|1.4|STANDARD_ERROR_OF_MEAN|0.92||0.142|TWO_SIDED|95.0|-0.5|3.2||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.||3.2|-0.5|0.142
72434243|NCT01018511|144381851|SUPERIORITY_OR_OTHER_LEGACY|||||||0.874|TWO_SIDED|||||No adjustments for multiplicity were made.|Chi-squared|||Difference vs TOCAS (superiority test).||||0.874
72556830|NCT01175135|144644762|OTHER||LS Mean Difference|-1.66|STANDARD_ERROR_OF_MEAN|0.641||0.0052|TWO_SIDED|80.0|-2.48|-0.84||Reported p-value was 1-sided.|Mixed Models Analysis|||Uncontrolled hostility/excitement Score: MMRM model with fixed effect for baseline PANSS Marder hostility/excitement score, investigator site, treatment, visit, treatment by visit interaction and baseline PANSS Marder hostility/excitement score by visit interaction, and random effect for participant. The model was fit using an unstructured covariance matrix.||-0.84|-2.48|0.0052
72556831|NCT01175135|144644762|OTHER||LS Mean Difference|0.12|STANDARD_ERROR_OF_MEAN|0.523||0.5894|TWO_SIDED|80.0|-0.55|0.79||Reported p-value was 1-sided.|Mixed Models Analysis|||Anxiety/Depression Score: MMRM model with fixed effect for baseline PANSS Marder anxiety/depression score, investigator site, treatment, visit, treatment by visit interaction and baseline PANSS Marder anxiety/depression score by visit interaction, and random effect for participant. The model was fit using an unstructured covariance matrix.||0.79|-0.55|0.5894
72556832|NCT01175135|144644762|OTHER||LS Mean Difference|0.47|STANDARD_ERROR_OF_MEAN|0.526||0.8155|TWO_SIDED|80.0|-0.2|1.15||Reported p-value was 1-sided.|Mixed Models Analysis|||Anxiety/Depression Score: MMRM model with fixed effect for baseline PANSS Marder anxiety/depression score, investigator site, treatment, visit, treatment by visit interaction and baseline PANSS Marder anxiety/depression score by visit interaction, and random effect for participant. The model was fit using an unstructured covariance matrix.||1.15|-0.20|0.8155
72556833|NCT01175135|144644762|OTHER||LS Mean Difference|-1.68|STANDARD_ERROR_OF_MEAN|0.677||0.0069|TWO_SIDED|80.0|-2.55|-0.81||Reported p-value was 1-sided.|Mixed Models Analysis|||Anxiety/Depression Score: MMRM model with fixed effect for baseline PANSS Marder anxiety/depression score, investigator site, treatment, visit, treatment by visit interaction and baseline PANSS Marder anxiety/depression score by visit interaction, and random effect for participant. The model was fit using an unstructured covariance matrix.||-0.81|-2.55|0.0069
72556834|NCT01175135|144644763|OTHER||LS Mean Difference|-0.34|STANDARD_ERROR_OF_MEAN|0.559||0.2727|TWO_SIDED|80.0|-1.06|0.38||Reported p-value was 1-sided.|Mixed Models Analysis|||MMRM model with fixed effect for baseline PANSS derived BPRS core score, investigator site, treatment, visit, treatment by visit interaction and baseline PANSS derived BPRS core score by visit interaction, and random effect for participant. The model was fit using an unstructured covariance matrix.||0.38|-1.06|0.2727
72556835|NCT01175135|144644763|OTHER||LS Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.562||0.4747|TWO_SIDED|80.0|-0.76|0.69||Reported p-value was 1-sided.|Mixed Models Analysis|||MMRM model with fixed effect for baseline PANSS derived BPRS core score, investigator site, treatment, visit, treatment by visit interaction and baseline PANSS derived BPRS core score by visit interaction, and random effect for participant. The model was fit using an unstructured covariance matrix.||0.69|-0.76|0.4747
72556836|NCT01175135|144644763|OTHER||LS Mean Difference|-2.0|STANDARD_ERROR_OF_MEAN|0.723||0.0031|TWO_SIDED|80.0|-2.93|-1.07||Reported p-value was 1-sided.|Mixed Models Analysis|||MMRM model with fixed effect for baseline PANSS derived BPRS core score, investigator site, treatment, visit, treatment by visit interaction and baseline PANSS derived BPRS core score by visit interaction, and random effect for participant. The model was fit using an unstructured covariance matrix.||-1.07|-2.93|0.0031
72556837|NCT01175135|144644764|OTHER||LS Mean Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.196||0.3598|TWO_SIDED|80.0|-0.32|0.18||Reported p-value was 1-sided.|Mixed Models Analysis|||MMRM model with fixed effect for investigator site, treatment, visit, treatment by visit interaction and random effect for participant. The model was fit using an unstructured covariance matrix.||0.18|-0.32|0.3598
72556838|NCT01175135|144644764|OTHER||LS Mean Difference|0.12|STANDARD_ERROR_OF_MEAN|0.198||0.7275|TWO_SIDED|80.0|-0.13|0.37||Reported p-value was 1-sided.|Mixed Models Analysis|||MMRM model with fixed effect for investigator site, treatment, visit, treatment by visit interaction and random effect for participant. The model was fit using an unstructured covariance matrix.||0.37|-0.13|0.7275
72556839|NCT01175135|144644764|OTHER||LS Mean Difference|-0.75|STANDARD_ERROR_OF_MEAN|0.255||0.0019|TWO_SIDED|80.0|-1.07|-0.42||Reported p-value was 1-sided.|Mixed Models Analysis|||MMRM model with fixed effect for investigator site, treatment, visit, treatment by visit interaction and random effect for participant. The model was fit using an unstructured covariance matrix.||-0.42|-1.07|0.0019
72556840|NCT01175135|144644765|OTHER||LS Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|1.478||0.5429|TWO_SIDED|80.0|-2.06|1.74||Reported p-value was 1-sided.|Mixed Models Analysis|||MMRM model with fixed effect for baseline GAF score, investigator site, treatment, visit, treatment by visit interaction, baseline GAF score by visit interaction and random effect for participant. The model was fit using an unstructured covariance matrix.||1.74|-2.06|0.5429
72556841|NCT01175135|144644765|OTHER||LS Mean Difference|0.24|STANDARD_ERROR_OF_MEAN|1.492||0.4354|TWO_SIDED|80.0|-1.68|2.16||Reported p-value was 1-sided.|Mixed Models Analysis|||MMRM model with fixed effect for baseline GAF score, investigator site, treatment, visit, treatment by visit interaction, baseline GAF score by visit interaction and random effect for participant. The model was fit using an unstructured covariance matrix.||2.16|-1.68|0.4354
72381754|NCT03607422|144272021|SUPERIORITY||Adjusted Response Rate Difference|53.9|||<|0.001|TWO_SIDED|95.0|40.6|67.3|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||67.3|40.6|<0.001
72381755|NCT03607422|144272021|SUPERIORITY||Adjusted Response Rate Difference|39.4|||<|0.001|TWO_SIDED|95.0|25.7|53.1|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||53.1|25.7|<0.001
72381756|NCT03607422|144272022|SUPERIORITY||Adjusted Response Rate Difference|53.1|||<|0.001|TWO_SIDED|95.0|40.0|66.1|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||66.1|40.0|<0.001
72381757|NCT03607422|144272022|SUPERIORITY||Adjusted Response Rate Difference|35.0|||<|0.001|TWO_SIDED|95.0|21.8|48.2|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||48.2|21.8|<0.001
72434244|NCT01018511|144381851|SUPERIORITY_OR_OTHER_LEGACY|||||||0.24|TWO_SIDED|||||No adjustments for multiplicity were made.|Chi-squared|||Difference vs TOCAS (superiority test).||||0.240
72434245|NCT01018511|144381851|SUPERIORITY_OR_OTHER_LEGACY|||||||0.324|TWO_SIDED|||||No adjustments for multiplicity were made.|Chi-squared|||Difference vs placebo (superiority test).||||0.324
72556842|NCT01175135|144644765|OTHER||LS Mean Difference|2.53|STANDARD_ERROR_OF_MEAN|1.907||0.093|TWO_SIDED|80.0|0.08|4.99||Reported p-value was 1-sided.|Mixed Models Analysis|||MMRM model with fixed effect for baseline GAF score, investigator site, treatment, visit, treatment by visit interaction, baseline GAF score by visit interaction and random effect for participant. The model was fit using an unstructured covariance matrix.||4.99|0.08|0.0930
72556843|NCT05283148|144644790|OTHER|Distribution was non-normal, so a Wilcoxon rank-sum test (two-sided) was used.||||||0.321||||||A p-value \< 0.05 was considered statistically significant.|Wilcoxon rank-sum test (two-sided)|||Comparison between Group A and Group B as defined above. Values are reported as median (full range) for each group, measured by DXA at the lumbar spine. Distribution was non-normal, so a Wilcoxon rank-sum test (two-sided) was used. A p-value \< 0.05 was considered statistically significant.||||0.321
72381758|NCT03607422|144272023|SUPERIORITY||Adjusted Response Rate Difference|60.2|||<|0.001|TWO_SIDED|95.0|47.5|72.9|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||72.9|47.5|<0.001
72381759|NCT03607422|144272023|SUPERIORITY||Adjusted Response Rate Difference|46.7|||<|0.001|TWO_SIDED|95.0|33.4|59.9|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||59.9|33.4|<0.001
72381760|NCT03607422|144272024|SUPERIORITY||Adjusted Response Rate Difference|46.4|||<|0.001|TWO_SIDED|95.0|33.2|59.6|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||59.6|33.2|<0.001
72381761|NCT03607422|144272024|SUPERIORITY||Adjusted Response Rate Difference|34.9|||<|0.001|TWO_SIDED|95.0|21.4|48.4|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||48.4|21.4|<0.001
72381762|NCT03607422|144272025|SUPERIORITY||Adjusted Response Rate Difference|46.2|||<|0.001|TWO_SIDED|95.0|32.4|60.0|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||60.0|32.4|<0.001
72381763|NCT03607422|144272025|SUPERIORITY||Adjusted Response Rate Difference|31.3|||<|0.001|TWO_SIDED|95.0|17.3|45.3|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||45.3|17.3|<0.001
72381764|NCT03607422|144272026|SUPERIORITY||Adjusted Response Rate Difference|5.0||||0.075|TWO_SIDED|95.0|-0.5|10.6|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||10.6|-0.5|0.075
72381765|NCT03607422|144272026|SUPERIORITY||Adjusted Response Rate Difference|12.7||||0.005|TWO_SIDED|95.0|3.9|21.5|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||21.5|3.9|0.005
72381766|NCT03607422|144272027|SUPERIORITY||Adjusted Response Rate Difference|3.2||||0.151|TWO_SIDED|95.0|-1.2|7.6|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||7.6|-1.2|0.151
72381767|NCT03607422|144272028|SUPERIORITY||Adjusted Response Rate Difference|12.9||||0.008|TWO_SIDED|95.0|3.4|22.3|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||22.3|3.4|0.008
72434246|NCT01018511|144381851|SUPERIORITY_OR_OTHER_LEGACY|||||||0.043|TWO_SIDED|||||No adjustments for multiplicity were made.|Chi-squared|||Difference vs placebo (superiority test).||||0.043
72434247|NCT01018511|144381851|SUPERIORITY_OR_OTHER_LEGACY|||||||0.407|TWO_SIDED|||||No adjustments for multiplicity were made.|Chi-squared|||Difference vs placebo (superiority test).||||0.407
72434248|NCT01018511|144381858|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||No adjustments for multiplicity were made.|Chi-squared|||Difference vs TOCAS.||||<.001
72381768|NCT03607422|144272029|SUPERIORITY||Adjusted Response Rate Difference|-18.0|||<|0.001|TWO_SIDED|95.0|-28.0|-8.0|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||-8.0|-28.0|<0.001
72434249|NCT01018511|144381858|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||No adjustments for multiplicity were made.|Chi-squared|||Difference vs TOCAS.||||<.001
72493960|NCT02161211|144516845|SUPERIORITY|||||||0.673|||||||Chi-squared|df = 2||Null hypothesis = no difference in frequency in relapse between groups||||.673
72381769|NCT03607422|144272029|SUPERIORITY||Adjusted Response Rate Difference|-17.9||||0.001|TWO_SIDED|95.0|-28.1|-7.7|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||-7.7|-28.1|0.001
72381770|NCT03607422|144272030|SUPERIORITY||Adjusted Response Rate Difference|51.5|||<|0.001|TWO_SIDED|95.0|34.8|68.3|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||68.3|34.8|<0.001
72381771|NCT03607422|144272030|SUPERIORITY||Adjusted Response Rate Difference|29.2||||0.001|TWO_SIDED|95.0|11.8|46.6|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||46.6|11.8|0.001
72381772|NCT03607422|144272031|SUPERIORITY||Adjusted Response Rate Difference|53.2|||<|0.001|TWO_SIDED|95.0|38.4|68.0|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||68.0|38.4|<0.001
72381773|NCT03607422|144272031|SUPERIORITY||Adjusted Response Rate Difference|31.8|||<|0.001|TWO_SIDED|95.0|16.5|47.1|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||47.1|16.5|<0.001
72434250|NCT01018511|144381858|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||No adjustments for multiplicity were made.|Chi-squared|||Difference vs placebo.||||<.001
72434251|NCT01018511|144381858|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||No adjustments for multiplicity were made.|Chi-squared|||Difference vs placebo.||||<.001
72434252|NCT01018511|144381858|SUPERIORITY_OR_OTHER_LEGACY|||||||0.058|TWO_SIDED|||||No adjustments for multiplicity were made.|Chi-squared|||Difference vs placebo.||||0.058
72493961|NCT02161211|144516846|SUPERIORITY||Wald Chi-squared|-0.278||||0.133|TWO_SIDED|95.0|-0.64|0.084|||Wald Chi-squared|Negative binomial regression with offset of natural log of possible drinking days||||.084|-.64|.133
72381774|NCT03607422|144272032|SUPERIORITY||Adjusted Response Rate Difference|48.9|||<|0.001|TWO_SIDED|95.0|33.8|64.1|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||64.1|33.8|<0.001
72381775|NCT03607422|144272032|SUPERIORITY||Adjusted Response Rate Difference|37.3|||<|0.001|TWO_SIDED|95.0|21.1|53.6|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||53.6|21.1|<0.001
72381776|NCT03607422|144272033|SUPERIORITY||Adjusted Response Rate Difference|53.8|||<|0.001|TWO_SIDED|95.0|37.4|70.2|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||70.2|37.4|<0.001
72381777|NCT03607422|144272033|SUPERIORITY||Adjusted Response Rate Difference|42.0|||<|0.001|TWO_SIDED|95.0|24.3|59.7|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||59.7|24.3|<0.001
72381778|NCT03607422|144272034|SUPERIORITY||Adjusted Response Rate Difference|45.3|||<|0.001|TWO_SIDED|95.0|28.0|62.7|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||62.7|28.0|<0.001
72381779|NCT03607422|144272034|SUPERIORITY||Adjusted Response Rate Difference|29.8||||0.002|TWO_SIDED|95.0|10.7|48.8|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||48.8|10.7|0.002
72381780|NCT03607422|144272035|SUPERIORITY||Adjusted Response Rate Difference|17.1|||<|0.001|TWO_SIDED|95.0|7.5|26.7|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||26.7|7.5|<0.001
72381781|NCT03607422|144272035|SUPERIORITY||Adjusted Response Rate Difference|13.7||||0.006|TWO_SIDED|95.0|3.9|23.5|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||23.5|3.9|0.006
72381782|NCT03607422|144272036|SUPERIORITY||LS Mean Difference|-55.93|STANDARD_ERROR_OF_MEAN|7.284|<|0.001|TWO_SIDED|95.0|-70.32|-41.55|||Mixed Effect Model Repeated Measurement|Mixed-effect model repeat measurement with Baseline, treatment, visit, treatment by visit interaction, and Baseline vIGA-AD category in the model.|Difference = Upadacitinib - Placebo|||-41.55|-70.32|<0.001
72381783|NCT03607422|144272036|SUPERIORITY||LS Mean Difference|-36.54|STANDARD_ERROR_OF_MEAN|7.384|<|0.001|TWO_SIDED|95.0|-51.12|-21.96|||Mixed Effect Model Repeated Measurement|Mixed-effect model repeat measurement with Baseline, treatment, visit, treatment by visit interaction, and Baseline vIGA-AD category in the model.|Difference = Upadacitinib - Placebo|||-21.96|-51.12|<0.001
72381784|NCT03607422|144272037|SUPERIORITY||LS Mean Difference|-42.62|STANDARD_ERROR_OF_MEAN|6.432|<|0.001|TWO_SIDED|95.0|-55.34|-29.9|||Mixed Effect Model Repeated Measurement|Mixed-Effect Model Repeat Measurement with Baseline, treatment, visit, treatment by visit interaction, and Baseline vIGA-AD category in the model.|Difference = Upadacitinib - Placebo|||-29.90|-55.34|<0.001
72381785|NCT03607422|144272037|SUPERIORITY||LS Mean Difference|-35.66|STANDARD_ERROR_OF_MEAN|6.447|<|0.001|TWO_SIDED|95.0|-48.41|-22.9|||Mixed Effect Model Repeated Measurement|Mixed-Effect Model Repeat Measurement with Baseline, treatment, visit, treatment by visit interaction, and Baseline vIGA-AD category in the model.|Difference = Upadacitinib - Placebo|||-22.90|-48.41|<0.001
72434253|NCT01018511|144381859|SUPERIORITY_OR_OTHER_LEGACY|||||||0.053|TWO_SIDED|||||No adjustments for multiplicity were made.|Chi-squared|||Difference vs TOCAS.||||0.053
72381786|NCT03607422|144272038|SUPERIORITY||Adjusted Response Rate Difference|52.5|||<|0.001|TWO_SIDED|95.0|36.9|68.1|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||68.1|36.9|<0.001
72381787|NCT03607422|144272038|SUPERIORITY||Adjusted Response Rate Difference|38.1|||<|0.001|TWO_SIDED|95.0|21.2|54.9|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||54.9|21.2|<0.001
72381788|NCT03607422|144272039|SUPERIORITY||Adjusted Response Rate Difference|55.9|||<|0.001|TWO_SIDED|95.0|35.5|76.3|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||76.3|35.5|<0.001
72381789|NCT03607422|144272039|SUPERIORITY||Adjusted Response Rate Difference|49.6|||<|0.001|TWO_SIDED|95.0|26.3|72.9|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||72.9|26.3|<0.001
72381790|NCT03607422|144272040|SUPERIORITY||LS Mean Difference|-44.9|STANDARD_ERROR_OF_MEAN|6.492|<|0.001|TWO_SIDED|95.0|-57.74|-32.06|||Mixed Effect Model Repeated Measurement|Mixed-effect model repeat measurement with Baseline, treatment, visit, treatment by visit interaction, and Baseline vIGA-AD category|Difference = Upadacitinib - Placebo|||-32.06|-57.74|<0.001
72381791|NCT03607422|144272040|SUPERIORITY||LS Mean Difference|-29.98|STANDARD_ERROR_OF_MEAN|6.383|<|0.001|TWO_SIDED|95.0|-42.6|-17.36|||Mixed Effect Model Repeated Measurement|Mixed-effect model repeat measurement with Baseline, treatment, visit, treatment by visit interaction, and Baseline vIGA-AD category|Difference = Upadacitinib - Placebo|||-17.36|-42.60|<0.001
72381792|NCT03607422|144272041|SUPERIORITY||Adjusted Response Rate Difference|27.8||||0.016|TWO_SIDED|95.0|5.2|50.4|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||50.4|5.2|0.016
72381793|NCT03607422|144272041|SUPERIORITY||Adjusted Response Rate Difference|22.3||||0.062|TWO_SIDED|95.0|-1.1|45.7|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||45.7|-1.1|0.062
72434254|NCT01018511|144381859|SUPERIORITY_OR_OTHER_LEGACY|||||||0.031|TWO_SIDED|||||No adjustments for multiplicity were made.|Chi-squared|||Difference vs TOCAS.||||0.031
72434255|NCT01018511|144381859|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||No adjustments for multiplicity were made.|Chi-squared|||Difference vs placebo.||||<.001
72434256|NCT01018511|144381859|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||No adjustments for multiplicity were made.|Chi-squared|||Difference vs placebo.||||<.001
72434257|NCT01018511|144381859|SUPERIORITY_OR_OTHER_LEGACY|||||||0.018|TWO_SIDED|||||No adjustments for multiplicity were made.|Chi-squared|||Difference vs placebo.||||0.018
72556844|NCT05283148|144644791|OTHER|Welch two-sample t-test (two-sided) was used to account for unequal variances.||||||0.714||||||A p-value \< 0.05 was considered statistically significant.|Welch two sample t-test|||Comparison between Group A and Group B as defined above. Values are reported as median ± full range for each group, derived from DXA lumbar spine scans. Welch two-sample t-test (two-sided) was used to account for unequal variances. A p-value \< 0.05 was considered statistically significant.||||0.714
72556845|NCT05283148|144644792|OTHER|Distribution was non-normal, so a Wilcoxon rank-sum test (two-sided) was used.||||||0.09||||||p-value \< 0.05 was considered statistically significant.|Wilcoxon rank-sum test (two-sided)|||Comparison between Group A and Group B as defined above. Values are reported as median (full range) for each group, measured by DXA at the total hip. Distribution was non-normal, so a Wilcoxon rank-sum test (two-sided) was used. A p-value \< 0.05 was considered statistically significant.||||0.09
72556846|NCT05283148|144644793|OTHER|Welch two-sample t-test (two-sided) was used to account for unequal variances.||||||0.604||||||A p-value \< 0.05 was considered statistically significant.|Welch two sample t-test (two sided)|||Comparison between Group A and Group B as defined above. Values are reported as median ± full range for each group, derived from DXA total hip scans. Welch two-sample t-test (two-sided) was used to account for unequal variances. A p-value \< 0.05 was considered statistically significant.||||0.604
72556847|NCT05283148|144644794|OTHER|Distribution was non-normal, so a Wilcoxon rank-sum test (two-sided) was used.||||||0.013||||||A p-value \< 0.05 was considered statistically significant.|Wilcoxon rank-sum test (two-sided)|||Comparison between Group A and Group B as defined above. Values are reported as median (full range) for each group, measured by DXA at the femoral neck. Distribution was non-normal, so a Wilcoxon rank-sum test (two-sided) was used. A p-value \< 0.05 was considered statistically significant.||||0.013
72556848|NCT05283148|144644795|OTHER|Welch two-sample t-test (two-sided) was used to account for unequal variances.||||||0.166||||||A p-value \< 0.05 was considered statistically significant.|Welch two sample t-test|||Comparison between Group A and Group B as defined above. Values are reported as median ± full range for each group, derived from DXA femoral neck scans. Welch two-sample t-test (two-sided) was used to account for unequal variances. A p-value \< 0.05 was considered statistically significant.||||0.166
72556849|NCT05283148|144644796|OTHER|Welch two-sample t-test (two-sided) was used to account for unequal variances.||||||0.23||||||A p-value \< 0.05 was considered statistically significant.|Welch two sample t-test (two sided)|||Comparison between Group A and Group B as defined above. Values are reported as median (interquartile range) for each group, based on the ASCQ-Me Pain Impact instrument (lower scores indicate worse pain impact). Welch two-sample t-test (two-sided) was used to account for unequal variances. A p-value \< 0.05 was considered statistically significant.||||0.23
72556850|NCT00095784|144644805|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||Mixed Models Analysis|5 degrees of freedom test over six time points: day 1 (pre-treatment) and days 5, 12, 43, 47, and 54 post treatment.||Mixed effects regression analysis of change over time in CD34+ cell levels. Analysis performed on log scale.||||<0.0001
72556851|NCT00095784|144644811|SUPERIORITY_OR_OTHER_LEGACY|||||||0.29|||||||Mixed Models Analysis|5 degrees of freedom test over six time points: day 1 (pre-treatment) and days 5, 12, 43, 47, and 54 post treatment.||Mixed effects regression analysis of change over time in CXCR4 levels. Analysis performed on log scale.||||0.29
72556852|NCT00095784|144644817|SUPERIORITY_OR_OTHER_LEGACY|||||||0.99|||||||Mixed Models Analysis|5 degrees of freedom test over six time points: day 1 (pre-treatment) and days 5, 12, 43, 47, and 54 post treatment.||Mixed effects regression analysis of change over time in hemoglobin F levels.||||0.99
72556853|NCT00608322|144644827|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.03||||0.37|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||0.37
72556854|NCT00834444|144644829|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|96.9||||||90.0|87.8|107.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||107|87.8|
72618645|NCT01026038|144768107|SUPERIORITY_OR_OTHER||GMC ratio|1.18|||||TWO_SIDED|95.0|0.5|2.79||||||Serotype 6B: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||2.79|0.50|
72381794|NCT03607422|144272042|SUPERIORITY||Adjusted Response Rate Difference|38.9|||<|0.001|TWO_SIDED|95.0|18.4|59.4|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||59.4|18.4|<0.001
72381795|NCT03607422|144272042|SUPERIORITY||Adjusted Response Rate Difference|5.9||||0.51|TWO_SIDED|95.0|-11.7|23.6|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||23.6|-11.7|0.510
72381796|NCT03693170|144272043|OTHER|||||||||||||||||"The null hypothesis that the true response rate is 30% will be tested against a one-sided alternative.~The cORR will be provided with a corresponding Clopper-Pearson (exact) binomial 95% CI for the Efficacy Set.~This design yields a 1-sided type I error rate equal to 1.6% and power of 80% when the true response rate is 45%."|If 37 or more confirmed responses were observed in the 90 treated subjects with a centrally confirmed BRAFV600E mutation, corresponding to a lower limit of Clopper-Pearson (exact) binomial 95% CI exceeding 30%, the study was considered to have met its primary endpoint. If more than 90 subjects were enrolled, the lower limit of Clopper-Pearson was to be used for decision.|||
72556855|NCT00834444|144644830|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|100.0||||||90.0|97.9|103.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||103|97.9|
72556856|NCT00834444|144644831|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|100.0||||||90.0|97.7|103.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||103|97.7|
72556857|NCT00835614|144644832|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model containing factors for sequence of products, subjects within sequence, periods, and products was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|90.9||||||90.0|87.5|94.4|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||94.4|87.5|
72556858|NCT00835614|144644833|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model containing factors for sequence of products, subjects within sequence, periods, and products was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|92.1||||||90.0|90.3|93.9|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||93.9|90.3|
72556859|NCT00835614|144644834|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model containing factors for sequence of products, subjects within sequence, periods, and products was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|92.2||||||90.0|90.4|94.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||94|90.4|
72556860|NCT00606281|144644835|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.0|||<|0.001|TWO_SIDED|95.0|-9.4|-2.7|||ANCOVA|||||-2.7|-9.4|<0.001
72556861|NCT00606281|144644836|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7|||<|0.001||95.0|-1.1|-0.3|||ANCOVA|||||-0.3|-1.1|<0.001
72556862|NCT00829712|144644838|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model containing factors for sequence of products, subjects within sequence, periods, and products was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|100.95||||||90.0|94.02|108.39|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||108.39|94.02|
72556863|NCT00829712|144644839|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model containing factors for sequence of products, subjects within sequence, periods, and products was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|99.05||||||90.0|95.08|103.19|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||103.19|95.08|
72556864|NCT00829712|144644840|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model containing factors for sequence of products, subjects within sequence, periods, and products was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|99.94||||||90.0|96.08|103.95|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||103.95|96.08|
72556865|NCT02213263|144644862|EQUIVALENCE|Equivalence was tested within the pre-specified margins of (-16%, 16%) 95% confidence interval.|Difference in ORR|4.66|||||TWO_SIDED|95.0|-4.16|13.47||||||Difference in ORR between PF-05280586 and rituximab-EU was computed using the stratified Mantel-Haenszel method. The 95% confidence interval for the difference was calculated using the asymptotic stratified method proposed by Miettinen and Nurminen.||13.47|-4.16|
72556866|NCT02213263|144644868|SUPERIORITY||Hazard Ratio (HR)|1.163||||0.45|TWO_SIDED|95.0|0.786|1.72||A log-rank test stratified by follicular lymphoma international prognostic index 2 (FLIPI2) risk was used to compare the treatment groups with respect to TTF at a 2-sided alpha level of 0.05.|Log Rank||Hazard ratio and its confidence intervals (CIs) were estimated from Cox Proportional hazards model stratified by FLIPI2 risk categorization.|||1.720|0.786|0.450
72381797|NCT03402659|144272060|OTHER||Mean Difference (Final Values)|-0.06098|STANDARD_ERROR_OF_MEAN|0.105548||0.564|TWO_SIDED|95.0|-0.26973|0.14777|||Mixed Models Analysis|||Mean change from baseline neflamapimod vs placebo||0.14777|-0.26973|0.564
72381798|NCT03402659|144272061|OTHER||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|2.72||0.823|TWO_SIDED|95.0|-6.0|4.8|||Mixed Models Analysis|||Mean change from baseline neflamapimod vs placebo||4.8|-6.0|0.823
72556867|NCT02213263|144644869|SUPERIORITY||Hazard Ratio (HR)|1.393||||0.189|TWO_SIDED|95.0|0.847|2.291|||Log Rank|A log-rank test stratified by FLIPI2 risk was used to compare the treatment groups with respect to PFS at a 2-sided alpha level of 0.05.|Hazard ratio and its CIs were estimated from Cox Proportional hazards model stratified by FLIPI2 risk categorization.|||2.291|0.847|0.189
72556868|NCT02213263|144644870|SUPERIORITY||Mean Difference (Final Values)|-2.31|||||TWO_SIDED|95.0|-11.09|6.5||||||Difference in CR between PF-05280586 and rituximab-EU was computed using the stratified Mantel-Haenszel method. The 95% confidence interval for the difference was calculated using the asymptotic stratified method proposed by Miettinen and Nurminen.||6.50|-11.09|
72556869|NCT02213263|144644871|SUPERIORITY||Hazard Ratio (HR)|1.492||||0.185|TWO_SIDED|95.0|0.823|2.704||A log-rank test stratified by FLIPI2 risk was used to compare the treatment groups with respect to DOR at a 2-sided alpha level of 0.05.|Log Rank||Hazard ratio and its CIs were estimated from Cox Proportional hazards model stratified by FLIPI2 risk categorization.|||2.704|0.823|0.185
72618646|NCT01026038|144768107|SUPERIORITY_OR_OTHER||GMC ratio|1.11|||||TWO_SIDED|95.0|0.56|2.19||||||Serotype 9V: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||2.19|0.56|
72381799|NCT03402659|144272062|OTHER||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.25||0.806|TWO_SIDED|95.0|-0.4|0.6|||Mixed Models Analysis|||Mean change from baseline neflamapimod vs placebo||0.6|-0.4|0.806
72493962|NCT02161211|144516846|SUPERIORITY||Wald Chi-squared|0.101||||0.562|TWO_SIDED|95.0|-0.24|0.44|||Wald Chi-squared|||||.44|-.24|.562
72381800|NCT03402659|144272063|OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.39||0.489|TWO_SIDED|95.0|-1.0|0.5|||ANCOVA|||Mean change from baseline neflamapimod vs placebo||0.5|-1.0|0.489
72493963|NCT02161211|144516847|SUPERIORITY|||||||0.982|||||||ANOVA|F(2,105) = .019||||||.982
72381801|NCT03402659|144272064|OTHER||Mean Difference (Final Values)|-18.8|STANDARD_ERROR_OF_MEAN|8.6||0.031|TWO_SIDED|95.0|-35.8|-1.8|||ANCOVA|||Mean change from baseline neflamapimod vs placebo||-1.8|-35.8|0.031
72381802|NCT03402659|144272065|OTHER||Mean Difference (Final Values)|-2.0|STANDARD_ERROR_OF_MEAN|0.79||0.012|TWO_SIDED|95.0|-3.6|-0.5|||ANCOVA|||Mean change from baseline neflamapimod vs placebo||-0.5|-3.6|0.012
72556870|NCT02213263|144644872|SUPERIORITY||Hazard Ratio (HR)|2.94||||0.319|TWO_SIDED|95.0|0.0||Due to smaller number of participants with an event, upper limit of 95% CI could not be calculated.|A log-rank test stratified by FLIPI2 risk was used to compare the treatment groups with respect to overall survival at a 2-sided alpha level of 0.05.|Log Rank||Hazard ratio and its CIs were estimated from Cox Proportional hazards model stratified by FLIPI2 risk categorization.||||0.000|0.319
72381803|NCT03402659|144272066|OTHER||Mean Difference (Final Values)|-117.4|STANDARD_ERROR_OF_MEAN|314.0||0.709|TWO_SIDED|95.0|-738.9|504.2|||ANCOVA|||Mean change from baseline neflamapimod vs placebo||504.2|-738.9|0.709
72381804|NCT03402659|144272067|OTHER||Mean Difference (Final Values)|-21.0|STANDARD_ERROR_OF_MEAN|16.03||0.192|TWO_SIDED|95.0|-52.7|10.7|||ANCOVA|||Mean change from baseline neflamapimod vs placebo||10.7|-52.7|0.192
72381805|NCT03402659|144272068|OTHER||Mean Difference (Final Values)|-21.0|STANDARD_ERROR_OF_MEAN|11.43||0.068|TWO_SIDED|95.0|-43.6|1.6|||ANCOVA|||Mean change from baseline neflamapimod vs placebo||1.6|-43.6|0.068
72381806|NCT03402659|144272069|OTHER||Mean Difference (Final Values)|-110.1|STANDARD_ERROR_OF_MEAN|77.11||0.156|TWO_SIDED|95.0|-262.7|42.4|||ANCOVA|||Mean change from baseline neflamapimod vs placebo||42.4|-262.7|0.156
72381807|NCT03402659|144272070|OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.0||0.59|TWO_SIDED|95.0|0.0|0.0|||ANCOVA|||Mean change from baseline neflamapimod vs placebo||0.0|-0.0|0.590
72381808|NCT01442038|144272071|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.948||||0.48|TWO_SIDED|95.0|0.818|1.099||The p-value and hazard ratio are from Cox proportional hazards model stratifying by reason for qualifying percutaneous coronary intervention (PCI): acute coronary syndrome (ACS) versus non-ACS indication, and history of diabetes (yes versus no).|Cox Proportional Hazards Model|||||1.099|0.818|0.48
72381809|NCT01442038|144272072|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.665||||0.4|TWO_SIDED|95.0|0.244|1.691||The p-value and hazard ratio are from Cox proportional hazards model stratifying by reason for qualifying PCI: ACS versus non-ACS indication, and history of diabetes (yes versus no).|Cox Proportional Hazards Model|||||1.691|0.244|0.40
72381810|NCT01442038|144272073|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.073||||0.82|TWO_SIDED|95.0|0.579|1.994||The p-value and hazard ratio are from Cox proportional hazards model stratifying by reason for qualifying PCI: ACS versus non-ACS indication, and history of diabetes (yes versus no).|Cox Proportional Hazards Model|||||1.994|0.579|0.82
72381811|NCT01442038|144272074|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.968||||0.81|TWO_SIDED|95.0|0.745|1.256||The p-value and hazard ratio are from Cox proportional hazards model stratifying by reason for qualifying PCI: ACS versus non-ACS indication, and history of diabetes (yes versus no).|Cox Proportional Hazards Model|||||1.256|0.745|0.81
72381812|NCT02128828|144272092|SUPERIORITY|||||||0.0079|||||||Wilcoxon (Mann-Whitney)|||||||0.0079
72381813|NCT03228420|144272093|SUPERIORITY||||||<|0.001||||||2-sided alpha level of 0.05|Fisher Exact|||||||<0.001
72381814|NCT01841736|144272104|SUPERIORITY||Hazard Ratio (HR)|0.53||||0.0005|TWO_SIDED|80.0|0.42|0.69|||Log Rank|Stratified log rank||||0.69|0.42|0.0005
72381815|NCT01841736|144272106|SUPERIORITY||Hazard Ratio (HR)|1.13||||0.7|TWO_SIDED|80.0|0.84|1.51|||Log Rank|Stratified Log-Rank||||1.51|0.84|0.7
72434258|NCT01018511|144381860|SUPERIORITY_OR_OTHER_LEGACY|||||||0.11|TWO_SIDED|||||No adjustments for multiplicity were made.|Chi-squared|||Difference vs TOCAS.||||0.110
72381816|NCT01052844|144272155|SUPERIORITY_OR_OTHER|||||||0.04||95.0|||||Chi-squared|||Complete protection from nausea and vomiting (CP) was defined as the absence of any episode of nausea or vomiting and no use of rescue medication. CP was further defined as either acute (ACP), when occurring during the first 24 hours after chemotherapy; delayed (DCP), when occurring during the period from days 2 through 5 after chemotherapy; or overall, when occurring over the entire period of the study (first 120 hours).||||0.04
72381817|NCT01052844|144272156|SUPERIORITY_OR_OTHER|||||||0.06||95.0|||||Chi-squared|||We evaluated associations between categorical variables using the Chi-Square test||||0.06
72381818|NCT01068652|144272158|NON_INFERIORITY_OR_EQUIVALENCE|The treatment comparison was based on a non-inferiority criterion and the following hypotheses were tested: H0: μDetemir - μBIAsp 30 ≥0.4% against the alternative hypothesis (Detemir non-inferior to BIAsp 30) HA: μDetemir - μBIAsp 30 \<0.4% where μBIAsp 30 and μDetemir are the mean HbA1c after 50 weeks of treatment with the two treatment regimens.|Mean Difference (Final Values)|0.11||||0.3406||95.0|-0.12|0.34|||ANCOVA|||To investigate the effect of different treatments, an analysis of covariance (ANCOVA) model was used to analyse HbA1c at week 50 with treatment group (2 categories: insulin detemir and aspart; BIAsp 30), country and pre-trial OAD(s) treatment (one OAD vs. more OADs) as factors and HbA1c at baseline (week 0) as a covariate. The treatment difference was estimated and a 95% confidence interval (CI) for the difference was calculated.||0.34|-0.12|0.3406
72381819|NCT05323656|144272290|SUPERIORITY||LS Mean Difference|5.05|STANDARD_ERROR_OF_MEAN|13.077||0.7008|TWO_SIDED|80.0|-11.98|22.0|||ANCOVA||The LS Mean difference is for the Setanaxib Group minus the Placebo Group|Null hypothesis: the mean best percentage change in the tumour size between the treatment groups are the same. With 25 patients per treatment group, using a 2-sided t-test, there will be 85% power to detect a 20% mean difference between the treatment groups in best percentage change in tumour size, with an estimated standard deviation of 30% and a 2 sided alpha of 20%.||22.0|-11.98|0.7008
72381820|NCT05323656|144272291|SUPERIORITY||Hazard Ratio (HR)|0.58||||0.1023|TWO_SIDED|80.0|0.38|0.89|||Regression, Cox|||Null hypothesis: The risk for progression, as defined by RECIST v1.1, is the same between treatment groups. If the true hazard ratio is 0.5, approximately 38 progression events as defined by RECIST v1.1 will be required to have \> 80% power to demonstrate a statistically significant difference in PFS with 2-sided p\<0.2||0.89|0.38|.1023
72434259|NCT01018511|144381860|SUPERIORITY_OR_OTHER_LEGACY|||||||0.071|TWO_SIDED|||||No adjustments for multiplicity were made.|Chi-squared|||Difference vs TOCAS.||||0.071
72434260|NCT01018511|144381860|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||No adjustments for multiplicity were made.|Chi-squared|||Difference vs placebo.||||<.001
72381821|NCT05323656|144272292|SUPERIORITY||LS Mean Difference|9.5|STANDARD_ERROR_OF_MEAN|8.89||0.2986|TWO_SIDED|80.0|-2.3|21.3||a priori threshold for significance (0.2) not met.|ANCOVA||The LS Mean difference is for the Setanaxib Group minus the Placebo Group.|Null Hypothesis: Mean difference in postbaseline CAF levels does not differ between treatment groups. ANCOVA model is on postbaseline CAFs level with a fixed factor for treatment and a covariate for baseline.||21.3|-2.3|0.2986
72381822|NCT05323656|144272293|SUPERIORITY||LS Mean Difference|6.83|STANDARD_ERROR_OF_MEAN|12.48||0.5918|TWO_SIDED|80.0|-9.86|23.52|||ANCOVA||The LS Mean difference is for the Setanaxib Group minus the Placebo Group.|Null Hypothesis: Mean difference in postbaseline CD8+ TILs does not differ between treatment groups. ANCOVA model is on postbaseline CD8+ TILs level with a fixed factor for treatment and a covariate for baseline.||23.52|-9.86|0.5918
72381823|NCT05323656|144272294|SUPERIORITY||LS Mean Difference|10.84|STANDARD_ERROR_OF_MEAN|8.37||0.2135|TWO_SIDED|80.0|-0.34|22.02|||ANCOVA||The LS Mean difference is for the Setanaxib Group minus the Placebo Group.|Null Hypothesis: Mean difference in postbaseline number of regulatory T-cells in tumour tissue does not differ between treatment groups. ANCOVA model is on postbaseline number of regulatory T-cells in tumour tissue level with a fixed factor for treatment and a covariate for baseline.||22.02|-0.34|0.2135
72381824|NCT05323656|144272298|SUPERIORITY||Hazard Ratio (HR)|0.448|||||TWO_SIDED|80.0|0.24|0.85||||||No formal test of significance undertaken.||0.85|0.24|
72381825|NCT05323656|144272301|SUPERIORITY||Mean Difference (Final Values)|17.76|STANDARD_ERROR_OF_MEAN|9.4||0.0782|TWO_SIDED|80.0|5.17|30.36|||ANCOVA|The LS Mean difference is for the Setanaxib Group minus the Placebo Group.||Null Hypothesis: Mean difference in postbaseline PD-L1 combined positive score (CPS) does not differ between treatment groups. ANCOVA model is on postbaseline PD-L1 CPS with a fixed factor for treatment and a covariate for baseline. Threshold for statistical significance = 0.2.||30.36|5.17|0.0782
72381826|NCT05323656|144272302|OTHER||Mean Difference (Net)|0.11|STANDARD_DEVIATION|0.578||0.22|TWO_SIDED||||||Wilcoxon signed rank test|||Within group test of hypothesis that screening and week 9 values are equal.||||0.22
72381827|NCT05323656|144272302|OTHER||Mean Difference (Net)|-0.18|STANDARD_DEVIATION|0.395||0.2|TWO_SIDED||||||Wilcoxon signed rank test|||Within group test of hypothesis that screening and week 9 values are equal.||||0.20
72381828|NCT05323656|144272303|OTHER||Mean Difference (Net)|0.05|STANDARD_DEVIATION|0.069||0.037|TWO_SIDED||||||Wilcoxon signed rank test|||Within group test of hypothesis that screening and week 9 values are equal.||||0.037
72381829|NCT05323656|144272303|OTHER||Mean Difference (Net)|-0.02|STANDARD_DEVIATION|0.039||0.123|TWO_SIDED||||||Wilcoxon signed rank test|||Within group test of hypothesis that screening and week 9 values are equal.||||0.123
72381830|NCT05323656|144272304|OTHER||Mean Difference (Net)|0.01|STANDARD_DEVIATION|0.017||0.41|TWO_SIDED||||||Wilcoxon signed rank test|||Within group test of hypothesis that screening and week 9 values are equal.||||0.41
72381831|NCT05323656|144272304|OTHER||Mean Difference (Net)|0.01|STANDARD_DEVIATION|0.023||0.11|TWO_SIDED||||||Wilcoxon signed rank test|||Within group test of hypothesis that screening and week 9 values are equal.||||0.11
72556871|NCT00367133|144644923|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||ANCOVA|Repeated Measures Model. Adjusted for baseline visual acuity and prior photocoagulation; Accounted for correlated data from subjects with 2 study eyes||P values for two group comparisons for difference in mean change.||||0.02
72381832|NCT03091777|144272323|SUPERIORITY||||||<|0.001|||||||Chi-squared, Corrected|||||||<0.001
72381833|NCT03091777|144272323|SUPERIORITY||||||<|0.001|||||||Chi-squared, Corrected|||||||<0.001
72381834|NCT02536833|144272324|SUPERIORITY||Mean Difference (Final Values)|-1.46||||0.575|TWO_SIDED|95.0|-6.57|3.65|||ANCOVA|||||3.65|-6.57|0.575
72381835|NCT02536833|144272324|SUPERIORITY||Mean Difference (Final Values)|-1.27||||0.643|TWO_SIDED|95.0|-6.63|4.09|||ANCOVA|||||4.09|-6.63|0.643
72381836|NCT02536833|144272324|SUPERIORITY||Mean Difference (Final Values)|0.34||||0.901|TWO_SIDED|95.0|-5.07|5.75|||ANCOVA|||||5.75|-5.07|0.901
72381837|NCT02536833|144272325|SUPERIORITY||Mean Difference (Final Values)|-2.99||||0.271|TWO_SIDED|95.0|-8.31|2.33|||ANCOVA|||||2.33|-8.31|0.271
72434261|NCT01018511|144381860|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||No adjustments for multiplicity were made.|Chi-squared|||Difference vs placebo.||||<.001
72434262|NCT01018511|144381860|SUPERIORITY_OR_OTHER_LEGACY|||||||0.019|TWO_SIDED|||||No adjustments for multiplicity were made.|Chi-squared|||Difference vs placebo.||||0.019
72434263|NCT04391309|144381895|SUPERIORITY|||||||0.435|||||||Log Rank|||||||0.435
72381838|NCT02536833|144272325|SUPERIORITY||Mean Difference (Final Values)|-0.37||||0.898|TWO_SIDED|95.0|-6.06|5.32|||ANCOVA|||||5.32|-6.06|0.898
72381839|NCT02536833|144272325|SUPERIORITY||Mean Difference (Final Values)|0.72||||0.795|TWO_SIDED|95.0|-4.74|6.18|||ANCOVA|||||6.18|-4.74|0.795
72381840|NCT02536833|144272326|SUPERIORITY||Mean Difference (Final Values)|-2.74||||0.283|TWO_SIDED|95.0|-7.74|2.26|||ANCOVA|||||2.26|-7.74|0.283
72381841|NCT02536833|144272326|SUPERIORITY||Mean Difference (Final Values)|-1.48||||0.588|TWO_SIDED|95.0|-6.82|3.86|||ANCOVA|||||3.86|-6.82|0.588
72381842|NCT02536833|144272326|SUPERIORITY||Mean Difference (Final Values)|-0.5||||0.853|TWO_SIDED|95.0|-5.76|4.76|||ANCOVA|||||4.76|-5.76|0.853
72381843|NCT02536833|144272327|SUPERIORITY||Mean Difference (Final Values)|-2.89||||0.292|TWO_SIDED|95.0|-8.26|2.49|||ANCOVA|||||2.49|-8.26|0.292
72381844|NCT02536833|144272327|SUPERIORITY||Mean Difference (Final Values)|0.25||||0.931|TWO_SIDED|95.0|-5.34|5.83|||ANCOVA|||||5.83|-5.34|0.931
72381845|NCT02536833|144272327|SUPERIORITY||Mean Difference (Final Values)|0.42||||0.878|TWO_SIDED|95.0|-4.92|5.76|||ANCOVA|||||5.76|-4.92|0.878
72381846|NCT02536833|144272328|SUPERIORITY||Mean Difference (Final Values)|1.16||||0.648|TWO_SIDED|95.0|-3.83|6.16|||ANCOVA|||||6.16|-3.83|0.648
72381847|NCT02536833|144272328|SUPERIORITY||Mean Difference (Final Values)|-3.14||||0.209|TWO_SIDED|95.0|-8.02|1.75|||ANCOVA|||||1.75|-8.02|0.209
72381848|NCT02536833|144272328|SUPERIORITY||Mean Difference (Final Values)|0.28||||0.915|TWO_SIDED|95.0|-4.78|5.33|||ANCOVA|||||5.33|-4.78|0.915
72381849|NCT02536833|144272329|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.969|TWO_SIDED|95.0|-5.16|5.36|||ANCOVA|||||5.36|-5.16|0.969
72434264|NCT04391309|144381896|SUPERIORITY|||||||1|||||||Fisher Exact|||All categories included in the analysis||||1
72434265|NCT04391309|144381897|SUPERIORITY|||||||0.391|||||||Wilcoxon (Mann-Whitney)|||||||0.391
72434266|NCT04391309|144381898|SUPERIORITY|||||||0.895|||||||Wilcoxon (Mann-Whitney)|||||||0.895
72434267|NCT04391309|144381899|SUPERIORITY|||||||0.702|||||||Wilcoxon (Mann-Whitney)|||||||0.702
72556872|NCT00367133|144644923|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||ANCOVA|Repeated Measures Model. Adjusted for baseline visual acuity and prior photocoagulation; Accounted for correlated data from subjects with 2 study eyes||P Values for 2 group comparisons of difference in mean change||||0.002
72556873|NCT00367133|144644923|SUPERIORITY_OR_OTHER|||||||0.49||95.0|||||ANCOVA|Repeated Measures Model. Adjusted for baseline visual acuity and prior photocoagulation; Accounted for correlated data from subjects with 2 study eyes||P Values for 2 group comparisons of difference in mean change||||0.49
72556874|NCT00367133|144644926|SUPERIORITY_OR_OTHER|||||||0.03||95.0|||||GEE Repeated Measures|Hochberg procedure used to determine statistical significance.||Proportion with 15-letter or more worsening||||0.03
72556875|NCT00367133|144644926|SUPERIORITY_OR_OTHER|||||||0.01||95.0|||||GEE Repeated Measures|Hochberg procedure used to determine statistical significance.||Proportion with 15-letter or more worsening||||0.01
72556876|NCT00367133|144644926|SUPERIORITY_OR_OTHER|||||||0.82||95.0|||||GEE Repeated Measures|Hochberg procedure used to determine statistical significance.||Proportion with 15-letter or more worsening||||0.82
72556877|NCT00367133|144644927|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|Repeated Measures Model. Accounted for correlated data from subjects with 2 study eyes; included baseline central subfield thickness as a covariate.||P value not adjusted for multiple comparisons||||<0.001
72556878|NCT00367133|144644927|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|Repeated Measures Model. Accounted for correlated data from subjects with 2 study eyes; included baseline central subfield thickness as a covariate.||P Value not adjusted for multiple comparisons||||<0.001
72556879|NCT00367133|144644927|SUPERIORITY_OR_OTHER|||||||0.91||95.0|||||ANCOVA|Repeated Measures Model. Accounted for correlated data from subjects with 2 study eyes; included baseline central subfield thickness as a covariate.||P Values not adjusted for multiple comparisons||||0.91
72556880|NCT00367133|144644929|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||GEE Repeated Measures|Accounted for correlated data from subjects with 2 study eyes; included baseline central subfield thickness as a covariate.||P Values not adjusted for multiple comparisons||||<0.001
72556881|NCT00367133|144644929|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||GEE Repeated Measures|Accounted for correlated data from subjects with 2 study eyes; included baseline central subfield thickness as a covariate.||P Values not adjusted for multiple comparisons||||<0.001
72556882|NCT00367133|144644929|SUPERIORITY_OR_OTHER|||||||0.6||95.0|||||GEE Repeated Measures|Accounted for correlated data from subjects with 2 study eyes; included baseline central subfield thickness as a covariate.||P Value not adjusted for multiple comparisons||||0.60
72493964|NCT02161211|144516848|SUPERIORITY|||||||0.685|||||||Chi-squared|||Null hypothesis = no difference in proportion between the groups||||.685
72556883|NCT00367133|144644930|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||GEE Repeated Measures|Accounted for correlated data from subjects with 2 study eyes; included baseline central subfield thickness as a covariate.||P Values not adjusted for multiple comparisons||||<0.001
72556884|NCT00367133|144644930|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||GEE Repeated Measures|Accounted for correlated data from subjects with 2 study eyes; included baseline central subfield thickness as a covariate.||P Value not adjusted for statistical analysis||||<0.001
72556885|NCT00367133|144644930|SUPERIORITY_OR_OTHER|||||||0.55||95.0|||||GEE Repeated Measures|Accounted for correlated data from subjects with 2 study eyes; included baseline central subfield thickness as a covariate.||P Value not adjusted for statistical analysis||||0.55
72556886|NCT00836758|144644938|SUPERIORITY_OR_OTHER|||||||0.007|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.007
72556887|NCT00906399|144644940|SUPERIORITY_OR_OTHER||Rate Ratio|0.725||||0.0114|TWO_SIDED|95.0|0.565|0.93|||Negative Binomial Regression|Based on negative binomial regression, with adjustment for baseline EDSS (\< 4 versus ≥ 4), baseline relapse rate, age (\< 40 versus ≥ 40 years).||||0.930|0.565|0.0114
72556888|NCT00906399|144644940|SUPERIORITY_OR_OTHER||Rate Ratio|0.644||||0.0007|TWO_SIDED|95.0|0.5|0.831|||Negative Binomial Regression|Based on negative binomial regression, with adjustment for baseline EDSS (\< 4 versus ≥ 4), baseline relapse rate, age (\< 40 versus ≥ 40).||||0.831|0.500|0.0007
72556889|NCT00906399|144644941|SUPERIORITY_OR_OTHER||Lesion Mean Ratio|0.72||||0.0008|TWO_SIDED|95.0|0.6|0.87|||Negative Binomial Regression|Lesion mean ratio (95% CI) and p-value based on negative binomial regression, adjusted for baseline number of T2 lesions.||||0.87|0.60|0.0008
72556890|NCT00906399|144644941|SUPERIORITY_OR_OTHER||Lesion Mean Ratio|0.33|||<|0.0001|TWO_SIDED|95.0|0.27|0.4|||Negative Binomial Regression|Lesion mean ratio (95% CI) and p-value based on negative binomial regression, adjusted for baseline number of T2 lesions.||||0.40|0.27|<0.0001
72381850|NCT02536833|144272329|SUPERIORITY||Mean Difference (Final Values)|-3.64||||0.174|TWO_SIDED|95.0|-8.89|1.61|||ANCOVA|||||1.61|-8.89|0.174
72381851|NCT02536833|144272329|SUPERIORITY||Mean Difference (Final Values)|0.31||||0.908|TWO_SIDED|95.0|-4.97|5.59|||ANCOVA|||||5.59|-4.97|0.908
72556891|NCT00906399|144644942|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.74||||0.02|TWO_SIDED|95.0|0.57|0.95||Based on Cox proportion hazards model, adjusted for baseline EDSS (\< 4 versus ≥ 4), age (\<40 versus ≥ 40 years), baseline relapse rate, and baseline Gd enhancing lesions (presence versus absence).|Cox Proportion Hazards model|||||0.95|0.57|0.0200
72556892|NCT00906399|144644942|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.61||||0.0003|TWO_SIDED|95.0|0.47|0.8||Based on Cox proportion hazards model, adjusted for baseline EDSS (\< 4 versus ≥ 4), age (\<40 versus ≥ 40 years), baseline relapse rate, and baseline Gd enhancing lesions (presence versus absence).|Cox Proportion Hazards model|||||0.80|0.47|0.0003
72556893|NCT00906399|144644943|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.62||||0.038|TWO_SIDED|95.0|0.4|0.97||Based on Cox Proportional Hazards model, adjusted for baseline EDSS (\< 4 versus ≥ 4) and age (\< 40 versus ≥ 40 years).|Cox Proportion Hazards model|||||0.97|0.40|0.0380
72556894|NCT00906399|144644943|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.62||||0.0383|TWO_SIDED|95.0|0.4|0.97||Based on Cox Proportional Hazards model, adjusted for baseline EDSS (\< 4 versus ≥ 4) and age (\< 40 versus ≥ 40 years).|Cox Proportion Hazards model|||||0.97|0.40|0.0383
72618647|NCT01026038|144768107|SUPERIORITY_OR_OTHER||GMC ratio|1.09|||||TWO_SIDED|95.0|0.58|2.06||||||Serotype 9V: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||2.06|0.58|
72556895|NCT01124786|144644944|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.994|||<|0.973|TWO_SIDED|95.0|0.746|1.326|||Log Rank||Hazard ratio and confidence interval presented above, so parameter dispersion not indicated in standard deviation field directly above.|If the median Overall Survival (OS) for the CO-1.01-treated patients is 7.7 months and the median OS for gemcitabine-treated patients with hENT1-low status is 4 months (hazard ratio of 0.53), then a total of 144 events of death in the hENT1-low subgroup will provide over 90% power at a 0.05 (2 sided) significance level for the comparison of CO-1.01 to gemcitabine in the hENT1-low patients.||1.326|0.746|<0.973
72556896|NCT01665508|144644963|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||Continuous variables were reported as the mean ± (SD) and categorical data presented as frequency and percentage of the sample. Comparisons between baseline and post-treatment SAQ scores, SF-36v2 scores, and CPET variables were performed using a paired t-test for normally distributed variables or a Wilcoxon signed-rank test for non-normally distributed variables. Normality was defined by the Shapiro-Wilk test. For categorical variables, data were compared using a chi-squared test.||||< 0.05
72556897|NCT00858780|144644972|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|7.17||||0.007|TWO_SIDED|95.0|1.72|29.82|||GEE Model|||Analysis was performed using a generalized estimating equations (GEE) model, using a logit link, a binomial distribution and an auto-regressive correlation structure, with treatment groups, visits, their interaction, and the stratification factor as factors in the model.||29.82|1.72|0.007
72556898|NCT00858780|144644972|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.71||||0.362|TWO_SIDED|95.0|0.54|5.41|||GEE Model|||Analysis was performed using a GEE model, using a logit link, a binomial distribution and an auto-regressive correlation structure, with treatment groups, visits, their interaction, and the stratification factor as factors in the model.||5.41|0.54|0.362
72556899|NCT00858780|144644972|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.2||||0.044|TWO_SIDED|95.0|1.04|16.99|||GEE Model|||Analysis was performed using a GEE model, using a logit link, a binomial distribution and an auto-regressive correlation structure, with treatment groups, visits, their interaction, and the stratification factor as factors in the model.||16.99|1.04|0.044
72556900|NCT02615249|144644995|OTHER||Kappa statistic|0.28|||||TWO_SIDED|95.0|-0.01|0.58||||||Comparison between 0.12 mg/cm2 copper sulfate and copper sulfate 2% in petrolatum||0.58|-0.01|
72381852|NCT02536833|144272330|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.334|TWO_SIDED|95.0|-0.1|0.29|||ANCOVA|||||0.29|-0.10|0.334
72381853|NCT02536833|144272330|SUPERIORITY||Mean Difference (Final Values)|0.13||||0.124|TWO_SIDED|95.0|-0.04|0.3|||ANCOVA|||||0.30|-0.04|0.124
72381854|NCT02536833|144272330|SUPERIORITY||Mean Difference (Final Values)|0.19||||0.032|TWO_SIDED|95.0|0.02|0.36|||ANCOVA|||||0.36|0.02|0.032
72381855|NCT02536833|144272331|SUPERIORITY||Mean Difference (Final Values)|-2.38||||0.405|TWO_SIDED|95.0|-8.0|3.24|||ANCOVA|||||3.24|-8.00|0.405
72381856|NCT02536833|144272331|SUPERIORITY||Mean Difference (Final Values)|1.89||||0.552|TWO_SIDED|95.0|-4.37|8.16|||ANCOVA|||||8.16|-4.37|0.552
72381857|NCT02536833|144272331|SUPERIORITY||Mean Difference (Final Values)|0.89||||0.763|TWO_SIDED|95.0|-4.91|6.68|||ANCOVA|||||6.68|-4.91|0.763
72556901|NCT02615249|144644995|OTHER||Kappa statistic|0.45|||||TWO_SIDED|95.0|0.24|0.66||||||Comparison between 0.24 mg/cm2 manganese chloride and manganese chloride 2% in petrolatum||0.66|0.24|
72556902|NCT02615249|144644995|OTHER||Kappa statistic|0.23|||||TWO_SIDED|95.0|0.07|0.38|||||Kappa statistic is for 0.33 mg/cm2 tin chloride vs 1% tin chloride in petrolatum reference allergen|Comparison between 0.33 mg/cm2 tin chloride and tin chloride 1% in petrolatum||0.38|0.07|
72556903|NCT02615249|144644995|OTHER||Kappa statistic|0.4|||||TWO_SIDED|95.0|0.15|0.65|||||Kappa statistic is for 0.22 mg Ti/cm2 ammonium titanium oxide oxalate vs 19% ammonium titanium oxide oxalate in petrolatum reference allergen|Comparison between 0.22 mg Ti/cm2 ammonium titanium oxide oxalate and ammnium titanium oxide oxalate 19% in petrolatum||0.65|0.15|
72381858|NCT02536833|144272332|SUPERIORITY||Mean Difference (Final Values)|-3.9||||0.173|TWO_SIDED|95.0|-9.5|1.71|||ANCOVA|||||1.71|-9.50|0.173
72434268|NCT04391309|144381900|SUPERIORITY|||||||1||||||P-value based on Fishers exact test, which enumerates all possible tables that have same margins as observed \& calculates proportion of tables where values are more extreme than observed. P-value of 1 = the observed table is the most extreme|Fisher Exact|||All categories included in the analysis.||||1
72381859|NCT02536833|144272332|SUPERIORITY||Mean Difference (Final Values)|1.12||||0.724|TWO_SIDED|95.0|-5.12|7.36|||ANCOVA|||||7.36|-5.12|0.724
72381860|NCT02536833|144272332|SUPERIORITY||Mean Difference (Final Values)|-0.32||||0.914|TWO_SIDED|95.0|-6.17|5.53|||ANCOVA|||||5.53|-6.17|0.914
72381861|NCT02536833|144272333|SUPERIORITY||Mean Difference (Final Values)|0.06||||0.529|TWO_SIDED|95.0|-0.12|0.24|||ANCOVA|||||0.24|-0.12|0.529
72381862|NCT02536833|144272333|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.259|TWO_SIDED|95.0|-0.08|0.28|||ANCOVA|||||0.28|-0.08|0.259
72434269|NCT04391309|144381901|SUPERIORITY|||||||1||||||P-value based on Fishers exact test, which enumerates all possible tables that have same margins as observed \& calculates proportion of tables where values are more extreme than observed. P-value of 1 = the observed table is the most extreme|Fisher Exact|||All categories included in the analysis||||1
72493965|NCT02161211|144516849|SUPERIORITY|||||||0.608|||||||Chi-squared|||Null hypothesis = no significant difference in frequency of hazardous drinking between groups||||.608
72381863|NCT02536833|144272333|SUPERIORITY||Mean Difference (Final Values)|-0.02||||0.807|TWO_SIDED|95.0|-0.21|0.16|||ANCOVA|||||0.16|-0.21|0.807
72381864|NCT02536833|144272334|SUPERIORITY||Mean Difference (Final Values)|-8.73||||0.049|TWO_SIDED|95.0|-17.44|-0.03|||ANCOVA|||||-0.03|-17.44|0.049
72381865|NCT02536833|144272334|SUPERIORITY||Mean Difference (Final Values)|-6.03||||0.211|TWO_SIDED|95.0|-15.49|3.43|||ANCOVA|||||3.43|-15.49|0.211
72381866|NCT02536833|144272334|SUPERIORITY||Mean Difference (Final Values)|-5.23||||0.254|TWO_SIDED|95.0|-14.24|3.78|||ANCOVA|||||3.78|-14.24|0.254
72381867|NCT02536833|144272335|SUPERIORITY||Mean Difference (Final Values)|-10.26||||0.036|TWO_SIDED|95.0|-19.82|-0.69|||ANCOVA|||||-0.69|-19.82|0.036
72381868|NCT02536833|144272335|SUPERIORITY||Mean Difference (Final Values)|-7.07||||0.17|TWO_SIDED|95.0|-17.18|3.05|||ANCOVA|||||3.05|-17.18|0.170
72381869|NCT02536833|144272335|SUPERIORITY||Mean Difference (Final Values)|-6.29||||0.171|TWO_SIDED|95.0|-15.33|2.74|||ANCOVA|||||2.74|-15.33|0.171
72381870|NCT02536833|144272336|SUPERIORITY||Mean Difference (Final Values)|0.39||||0.021|TWO_SIDED|95.0|0.06|0.72|||ANCOVA|||||0.72|0.06|0.021
72556904|NCT02615249|144644995|OTHER||Kappa statistic|0.52|||||TWO_SIDED|95.0|0.3|0.73|||||Kappa statistic is for 0.050 mg V/cm2 vanadium sulfate vs 1.5% vanadium sulfate in petrolatum reference allergen|Comparison between 0.050 mg/cm2 vanadium sulfate and vanadium sulfate 1.5% in petrolatum||0.73|0.30|
72556905|NCT02615249|144644995|OTHER||Kappa statistic|0.36|||||TWO_SIDED|95.0|0.07|0.38|||||Kappa statistic is for 0.24 mg/cm2 zinc chloride vs 2% zinc chloride in petrolatum reference allergen|Comparison betweenm 0.24 mg/cm2 zinc chloride and zinc chloride 2% in petrolatum||0.38|0.07|
72556906|NCT02055547|144645052|OTHER|Treatment comparison (MK-8521 125μg - placebo) of the slope of ISR/G during GGI at Tmax was performed using a linear mixed effect model with treatment and period as fixed effects and participant as random effect. The 90% confidence interval of GMR of the slope of ISR/G for MK-8521 125μg vs. placebo was calculated from the model.|Geometric mean ratio|4.61|||<|0.001|TWO_SIDED|90.0|3.69|5.76|||Linear mixed effect model||||Number of participants included in analysis: N=17 (3 period crossover study design was conducted for 12 participants in Part 3).|5.76|3.69|<0.001
72556907|NCT02055547|144645052|OTHER|Treatment comparison (MK-8521 35μg - placebo) of the slope of ISR/G during GGI at Tmax was performed using a linear mixed effect model with treatment and period as fixed effects and participant as random effect. The 90% confidence interval of GMR of the slope of ISR/G for MK-8521 35μg vs. placebo was calculated from the model.|Geometric mean ratio|2.67|||<|0.001|TWO_SIDED|90.0|2.12|3.36|||Linear mixed effect model||||Number of participants included in analysis: N=17 (3 period crossover study design was conducted for 12 participants in Part 3).|3.36|2.12|<0.001
72556908|NCT02055547|144645052|OTHER|"Treatment comparison (MK-8521 125μg - MK-8521 35μg) of the slope of ISR/G during GGI at Tmax was performed using a linear mixed effect model with treatment and period as fixed effects and participant as random effect. The 90% confidence interval of GMR of the slope of ISR/G for MK-8521 125μg vs.~MK-8521 35μg was calculated from the model."|Geometric mean ratio|1.73|||<|0.001|TWO_SIDED|90.0|1.38|2.16|||Linear mixed effect model||||Number of participants included in analysis: N=17 (3 period crossover study design was conducted for 12 participants in Part 3).|2.16|1.38|<0.001
72556909|NCT02055547|144645053|OTHER|Treatment comparison (MK-8521 125μg - placebo) of the ratio of ISR/G during GGI at Tmax was performed using a linear mixed effect model with treatment and period as fixed effects and participant as random effect. The 90% confidence interval of GMR of TWA120-160min of ratio (ISR/G) for MK-8521 125μg vs. placebo was calculated from the model.|Geometric mean ratio|3.04|||<|0.001|TWO_SIDED|90.0|2.62|3.53|||Linear mixed effect model||||Number of participants included in analysis: N=17 (3-period crossover study design was conducted for 12 participants in Part 3).|3.53|2.62|<0.001
72556910|NCT02055547|144645053|OTHER|Treatment comparison (MK-8521 35μg - placebo) of the ratio of ISR/G during GGI at Tmax was performed using a linear mixed effect model with treatment and period as fixed effects and participant as random effect. The 90% confidence interval of GMR of TWA120-160min of ratio (ISR/G) for MK-8521 35μg vs. placebo was calculated from the model.|Geometric mean ratio|1.94|||<|0.001|TWO_SIDED|90.0|1.67|2.26|||Linear mixed effect model||||Number of participants included in analysis: N=17 (3-period crossover study design was conducted for 12 participants in Part 3).|2.26|1.67|<0.001
72556911|NCT02055547|144645053|OTHER|Treatment comparison (MK-8521 125μg - 35μg) of the ratio of ISR/G during GGI at Tmax was performed using a linear mixed effect model with treatment and period as fixed effects and participant as random effect. The 90% confidence interval of GMR of TWA120-160min of ratio (ISR/G) for MK-8521 125μg - 35μg was calculated from the model.|Geometric mean ratio|1.57|||<|0.001|TWO_SIDED|90.0|1.35|1.82|||Linear mixed effect model||||Number of participants included in analysis: N=17 (3-period crossover study design was conducted for 12 participants in Part 3).|1.82|1.35|<0.001
72556912|NCT02055547|144645054|OTHER|The least squares means and 90% confidence intervals for the treatment difference (MK-8521 125mcg - placebo) in glucose (TWA0-160min) after a single dose was determined using a linear mixed effect model with treatment and period as fixed effects and participant as random effect.|Geometric mean ratio|0.65|||<|0.001|TWO_SIDED|90.0|0.6|0.7|||Linear mixed effect model||||Number of participants included in analysis: N=17 (3-period crossover study design was conducted for 12 participants in Part 3).|0.7|0.6|<0.001
72556913|NCT02055547|144645054|OTHER|The least squares means and 90% confidence intervals for the treatment difference (MK-8521 35μg - placebo) in glucose (TWA0-160min) after a single dose was determined using a linear mixed effect model with treatment and period as fixed effects and participant as random effect.|Geometric mean ratio|0.8|||<|0.001|TWO_SIDED|90.0|0.74|0.87|||Linear mixed effect model||||Number of participants included in analysis: N=17 (3-period crossover study design was conducted for 12 participants in Part 3).|0.87|0.74|<0.001
72556914|NCT02055547|144645054|OTHER|The least squares means and 90% confidence intervals for the treatment difference (MK-8521 125μg - MK-8521 35μg) in glucose (TWA0-160min) after a single dose was determined using a linear mixed effect model with treatment and period as fixed effects and participant as random effect.|Geometric mean ratio|0.81|||<|0.001|TWO_SIDED|90.0|0.75|0.87|||Linear mixed effect model||||Number of participants included in analysis: N=17 (3-period crossover study design was conducted for 12 participants in Part 3).|0.87|0.75|<0.001
72556915|NCT02055547|144645055|OTHER|The least squares means and 90% confidence intervals for the treatment difference (MK-8521 125μg vs. placebo) in Gmax after a single dose was determined using a linear mixed effect model with treatment and period as fixed effects and participant as random effect.|Geometric mean ratio|0.55|||<|0.001|TWO_SIDED|90.0|0.49|0.63|||Linear mixed effect model||||Number of participants included in analysis: N=17 (3 period crossover study design was conducted for 12 participants in Part 3).|0.63|0.49|<0.001
72556916|NCT02055547|144645055|OTHER|The least squares means and 90% confidence intervals for the treatment difference (MK-8521 35μg - placebo) in Gmax after a single dose was determined using a linear mixed effect model with treatment and period as fixed effects and participant as random effect.|Geometric mean ratio|0.71|||<|0.001|TWO_SIDED|90.0|0.62|0.81|||Linear mixed effect model||||Number of participants included in analysis: N=17 (3 period crossover study design was conducted for 12 participants in Part 3).|0.81|0.62|<0.001
72556917|NCT02055547|144645055|OTHER|The least squares means and 90% confidence intervals for the treatment difference (MK-8521 125μg - MK-8521 35μg) in Gmax after a single dose was determined using a linear mixed effect model with treatment and period as fixed effects and participant as random effect.|Geometric mean ratio|0.78||||0.004|TWO_SIDED|90.0|0.69|0.89|||Linear mixed effect model||||Number of participants included in analysis: N=17 (3 period crossover study design was conducted for 12 participants in Part 3).|0.89|0.69|0.004
72556918|NCT01248728|144645101|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5|||||||Mixed Models Analysis|||||||0.5
72556919|NCT01248728|144645102|SUPERIORITY_OR_OTHER_LEGACY|||||||0.02|||||||Mixed Models Analysis|||||||0.02
72556920|NCT01248728|144645104|SUPERIORITY_OR_OTHER_LEGACY|||||||0.09|||||||Mixed Models Analysis|||||||0.09
72556921|NCT01248728|144645105|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6|||||||Regression, Linear|||||||0.6
72556922|NCT02645253|144645144|SUPERIORITY_OR_OTHER||Slope|1.02|STANDARD_ERROR_OF_MEAN|0.0785|||TWO_SIDED|90.0|0.882|1.15|||Linear Model|||||1.15|0.882|
72556923|NCT02645253|144645146|SUPERIORITY_OR_OTHER||Slope|1.14|STANDARD_ERROR_OF_MEAN|0.0503|||TWO_SIDED|90.0|1.06|1.23|||Linear Model|||||1.23|1.06|
72556924|NCT02645253|144645148|SUPERIORITY_OR_OTHER||Slope|1.05|STANDARD_ERROR_OF_MEAN|0.119|||TWO_SIDED|90.0|0.801|1.31|||Linear Model|||||1.31|0.801|
72381871|NCT02536833|144272336|SUPERIORITY||Mean Difference (Final Values)|0.24||||0.131|TWO_SIDED|95.0|-0.07|0.55|||ANCOVA|||||0.55|-0.07|0.131
72556925|NCT02645253|144645158|SUPERIORITY_OR_OTHER||Slope|0.979|STANDARD_ERROR_OF_MEAN|0.0633|||TWO_SIDED|90.0|0.87|1.09|||Linear Model|||||1.09|0.870|
72556926|NCT02645253|144645163|SUPERIORITY_OR_OTHER||Slope|1.05|STANDARD_ERROR_OF_MEAN|0.0552|||TWO_SIDED|90.0|0.951|1.14|||Linear Model|||||1.14|0.951|
72556927|NCT02645253|144645175|SUPERIORITY_OR_OTHER||Ratio of Geometric LS mean (%)|102.99|||||TWO_SIDED|95.0|86.88|122.09|||ANCOVA||Day 1/ Day -1|||122.09|86.88|
72381872|NCT02536833|144272336|SUPERIORITY||Mean Difference (Final Values)|-0.04||||0.789|TWO_SIDED|95.0|-0.35|0.26|||ANCOVA|||||0.26|-0.35|0.789
72556928|NCT02645253|144645175|SUPERIORITY_OR_OTHER||Ratio of Geometric LS mean (%)|91.82|||||TWO_SIDED|95.0|77.32|109.04|||ANCOVA||Day 16 / Day -1|||109.04|77.32|
72556929|NCT02645253|144645175|SUPERIORITY_OR_OTHER||Ratio of Geometric LS mean (%)|105.92|||||TWO_SIDED|95.0|89.4|125.49|||ANCOVA||Day 1 / Day -1|||125.49|89.40|
72556930|NCT02645253|144645175|SUPERIORITY_OR_OTHER||Ratio of Geometric LS mean (%)|89.44|||||TWO_SIDED|95.0|75.35|106.16|||ANCOVA||Day 16 / Day -1|||106.16|75.35|
72556931|NCT02645253|144645175|SUPERIORITY_OR_OTHER||Ratio of Geometric LS mean (%)|99.82|||||TWO_SIDED|95.0|84.12|118.46|||ANCOVA||Day 1 / Day -1|||118.46|84.12|
72556932|NCT02645253|144645175|SUPERIORITY_OR_OTHER||Ratio of Geometric LS mean (%)|75.38||||||95.0|63.4|89.61|||ANCOVA||Day 16 / Day -1|||89.61|63.40|
72556933|NCT03325881|144645212|SUPERIORITY||Difference in LS Mean|-1.9|STANDARD_ERROR_OF_MEAN|2.48||0.451|TWO_SIDED|95.0|-6.8|3.1|||Mixed-effects model for repeated measure|||Number of participants with SHP465 was compared with placebo using the linear mixed-effects model for repeated measures (MMRM) that included treatment group, nominal visit, age group, interaction of the treatment group with the visits as factors, baseline ADHD-RS5 total score as a covariate and an adjustment for the interaction of the baseline ADHD-RS-5 Total Score with the visit.||3.1|-6.8|0.451
72556934|NCT03325881|144645213|SUPERIORITY||Difference in LS mean|-0.1|STANDARD_ERROR_OF_MEAN|0.2||0.597|TWO_SIDED|95.0|-0.5|0.3|||Mixed-effects model for repeated measure|||Number of participants with SHP465 was compared with placebo using the mixed effects model for repeated measures (MMRM) that includes treatment group, nominal visit, age group,interaction of the treatment group with the visit as factors, baseline CGI-S as a covariate and an adjustment for the interaction of the baseline CGI-S with the visit.||0.3|-0.5|0.597
72556935|NCT03676634|144645223|OTHER||single proportion|0.844|||||TWO_SIDED|95.0|0.672|0.947|||||Values listed in table are for Type A. Estimated Value for the Estimation Parameter for type B = 0.875. Lower limit = 0.710, upper limit = 0.965|Consider increase from baseline to post-dose values. Parameter is proportion achieving desired increase (≥ 3x or 4x increase in Type A and Type B NAC).|Proportion of participants achieving ≥ 3x or 4x increase in NAC values was calculated for both Type A and Type B. Primary endpoint was achieved if both Type A and Type B had proportion ≥50%.|.947|.672|
72556936|NCT02052895|144645229|SUPERIORITY_OR_OTHER||Difference of ROC-AUC|0.0317||||0.3924|TWO_SIDED|95.0|-0.0409|0.1043|||Regression, Logistic|||||0.1043|-0.0409|0.3924
72618648|NCT01026038|144768107|SUPERIORITY_OR_OTHER||GMC ratio|0.98|||||TWO_SIDED|95.0|0.46|2.13||||||Serotype 9V: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||2.13|0.46|
72618649|NCT01026038|144768107|SUPERIORITY_OR_OTHER||GMC ratio|0.98|||||TWO_SIDED|95.0|0.38|2.55||||||Serotype 14: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||2.55|0.38|
72381873|NCT01231230|144272413|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|15.0|||<|0.001|TWO_SIDED||||||ANOVA|||mean difference from baseline relative to placebo||||< 0.001
72381874|NCT01231230|144272413|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANOVA|||mean difference from baseline relative to placebo||||<0.001
72381875|NCT01231230|144272413|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||ANOVA|||mean difference from baseline relative to placebo||||>0.05
72381876|NCT02393690|144272414|SUPERIORITY|||||||0.0787|||||||Fisher Exact|||||||0.0787
72381877|NCT02393690|144272415|SUPERIORITY|||||||0.0787|||||||Fisher Exact|||||||0.0787
72556937|NCT03060486|144645230|OTHER||Signed Rank Score Difference|-60.0|||<|0.0001|TWO_SIDED||||||Wilcoxon signed-rank test|||||||<.0001
72556938|NCT03131895|144645237|EQUIVALENCE|A linear mixed effect model on the natural log-transformed parameters was performed with regimen, sequence and period as a fixed effect and subject nested within sequence as a random effect. The least squares means and difference of least squares means for the log-transformed parameters were exponentiated to obtain the point estimates and 90 percent (%) confidence intervals (CIs) on the original scale.|Least square (LS) mean ratio|1.0436||||0.5535|TWO_SIDED|90.0|0.9453|1.1521|||ANOVA|||||1.1521|0.9453|0.5535
72556939|NCT03131895|144645237|EQUIVALENCE|A linear mixed effect model on the natural log-transformed parameters was performed with regimen, sequence and period as a fixed effect and subject nested within sequence as a random effect. The least squares means and difference of least squares means for the log-transformed parameters were exponentiated to obtain the point estimates and 90% CIs on the original scale.|LS mean ratio|1.0185||||0.892|TWO_SIDED|90.0|0.9334|1.1113|||ANOVA|||||1.1113|0.9334|0.8920
72556940|NCT03131895|144645238|EQUIVALENCE|A linear mixed effect model on the natural log-transformed parameters was performed with regimen, sequence and period as a fixed effect and subject nested within sequence as a random effect. The least squares means and difference of least squares means for the log-transformed parameters were exponentiated to obtain the point estimates and 90% CIs on the original scale.|LS mean ratio|1.039||||0.3209|TWO_SIDED|90.0|0.9792|1.1024|||ANOVA|||||1.1024|0.9792|0.3209
72434270|NCT04391309|144381902|SUPERIORITY|||||||1||||||P-value based on Fishers exact test, which enumerates all possible tables that have same margins as observed \& calculates proportion of tables where values are more extreme than observed. P-value of 1 = the observed table is the most extreme|Fisher Exact|||All categories included in the anlysis.||||1
72434271|NCT04391309|144381903|SUPERIORITY|||||||1||||||P-value based on Fishers exact test, which enumerates all possible tables that have same margins as observed \& calculates proportion of tables where values are more extreme than observed. P-value of 1 = the observed table is the most extreme|Fisher Exact|||All categories included in the analysis.||||1
72434272|NCT04391309|144381904|SUPERIORITY|||||||1||||||P-value based on Fishers exact test, which enumerates all possible tables that have same margins as observed \& calculates proportion of tables where values are more extreme than observed. P-value of 1 = the observed table is the most extreme|Fisher Exact|||All categories included in the analysis.||||1
72434273|NCT04391309|144381905|SUPERIORITY|||||||1||||||P-value based on Fishers exact test, which enumerates all possible tables that have same margins as observed \& calculates proportion of tables where values are more extreme than observed. P-value of 1 = the observed table is the most extreme|Fisher Exact|||All categories included in the analysis.||||1
72434274|NCT04391309|144381906|SUPERIORITY|||||||1||||||P-value based on Fishers exact test, which enumerates all possible tables that have same margins as observed \& calculates proportion of tables where values are more extreme than observed. P-value of 1 = the observed table is the most extreme|Fisher Exact|||All categories included in the analysis.||||1
72434275|NCT04548622|144381909|SUPERIORITY|||||||0.01|||||||t-test, 2 sided|||||||0.01
72434276|NCT04548622|144381910|SUPERIORITY|||||||0.004|||||||t-test, 2 sided|||||||0.004
72434277|NCT04548622|144381911|SUPERIORITY|||||||0.001|||||||t-test, 2 sided|||||||0.001
72434278|NCT02908620|144381912|SUPERIORITY||Mean Difference (Final Values)|2.8|STANDARD_ERROR_OF_MEAN|2.74||0.322|TWO_SIDED|95.0|-3.06|8.69|||ANOVA||Least squares mean (marginal mean)|||8.69|-3.06|0.322
72434279|NCT02908620|144381913|SUPERIORITY||Mean Difference (Final Values)|-8.7|STANDARD_ERROR_OF_MEAN|5.48||0.134|TWO_SIDED|95.0|-20.38|2.99|||ANOVA||Least squares mean (marginal mean)|||2.99|-20.38|0.134
72434280|NCT02908620|144381914|SUPERIORITY||Mean Difference (Final Values)|4.1|STANDARD_ERROR_OF_MEAN|4.92||0.442|TWO_SIDED|95.0|-6.48|14.62|||ANOVA||Least squares mean (marginal mean)|||14.62|-6.48|0.442
72434281|NCT02908620|144381915|SUPERIORITY||Mean Difference (Final Values)|6.8|STANDARD_ERROR_OF_MEAN|4.78||0.172|TWO_SIDED|95.0|-3.27|16.9|||ANOVA||Least squares mean (marginal mean)|||16.90|-3.27|0.172
72618650|NCT01026038|144768107|SUPERIORITY_OR_OTHER||GMC ratio|1.23|||||TWO_SIDED|95.0|0.5|3.0||||||Serotype 14: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||3.00|0.50|
72434282|NCT04771273|144381922|OTHER|No confirmatory hypothesis testing was performed.|Odds Ratio (OR)|3.47||||0.001|TWO_SIDED|95.0|1.66|7.25||The p-value reported is considered nominal.|Regression, Logistic||Survodutide 2.4 mg vs. Placebo|The logistic regression model included actual treatment, presence of diabetes of any type and Baseline Fibrosis Score. Firth's penalized regression was used.||7.25|1.66|0.0010
72434283|NCT04771273|144381922|OTHER|No confirmatory hypothesis testing was performed.|Odds Ratio (OR)|9.52|||<|0.0001|TWO_SIDED|95.0|4.35|20.85||The p-value reported is considered nominal.|Regression, Logistic||Survodutide 4.8 mg vs. Placebo|The logistic regression model included actual treatment, presence of diabetes of any type and Baseline Fibrosis Score. Firth's penalized regression was used.||20.85|4.35|<0.0001
72434284|NCT04771273|144381922|OTHER|No confirmatory hypothesis testing was performed.|Odds Ratio (OR)|7.07|||<|0.0001|TWO_SIDED|95.0|3.1|16.16||The p-value reported is considered nominal.|Regression, Logistic|||The logistic regression model included actual treatment, presence of diabetes of any type and Baseline Fibrosis Score. Firth's penalized regression was used.||16.16|3.10|<.0001
72434285|NCT04771273|144381922|OTHER|"Logistic regression estimates were used as input for the MCP-Mod. The logistic regression model was fitted without an intercept, and included presence of diabetes of any type \[yes, no\], baseline fibrosis score \[F1, F2, F3\] and the dose group as factors.~P-values from the contrast tests corresponding to each dose response pattern evaluated were adjusted for the multiple comparisons performed."|||||<|0.0001|||||||MCP-Mod linear model fit|Linear model fit assumption||A flat vs. non-flat dose-response relationship across the 3 doses of survodutide and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 6 different plausible dose-response patterns (linear, exponential1, exponential2, Emax1, Emax2, quadratic) while keeping full control of the type I error (one-sided alpha of 0.050).||||<0.0001
72434286|NCT04771273|144381922|OTHER|"Logistic regression estimates were used as input for the MCP-Mod. The logistic regression model was fitted without an intercept, and included presence of diabetes of any type \[yes, no\], baseline fibrosis score \[F1, F2, F3\] and the dose group as factors.~P-values from the contrast tests corresponding to each dose response pattern evaluated were adjusted for the multiple comparisons performed."|||||<|0.0001|||||||MCP-Mod exponential-1 model fit|Model assumption: 25% of maximum effect is achieved at dose 3.0 mg.||A flat vs. non-flat dose-response relationship across the 3 doses of survodutide and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 6 different plausible dose-response patterns (linear, exponential1, exponential2, Emax1, Emax2, quadratic) while keeping full control of the type I error (one-sided alpha of 0.050).||||<0.0001
72434287|NCT04771273|144381922|OTHER|"Logistic regression estimates were used as input for the MCP-Mod. The logistic regression model was fitted without an intercept and included presence of diabetes of any type \[yes, no\], baseline fibrosis score \[F1, F2, F3\] and the dose group as factors.~P-values from the contrast tests corresponding to each dose response pattern evaluated were adjusted for the multiple comparisons performed."||||||0.0008|||||||MCP-Mod exponential -2 model fit|Model assumption: 5% of maximum effect is achieved at dose 3.0 mg.||A flat vs. non-flat dose-response relationship across the 3 doses of survodutide and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 6 different plausible dose-response patterns (linear, exponential1, exponential2, Emax1, Emax2, quadratic) while keeping full control of the type I error (one-sided alpha of 0.050).||||0.0008
72381878|NCT02393690|144272416|SUPERIORITY|||||||0.1764|||||||Log Rank|||||||0.1764
72381879|NCT02393690|144272417|SUPERIORITY|||||||0.0756|||||||Wilcoxon (Mann-Whitney)|||||||0.0756
72434288|NCT04771273|144381922|OTHER|"Logistic regression estimates were used as input for the MCP-Mod. The logistic regression model was fitted without an intercept and included presence of diabetes of any type \[yes, no\], baseline fibrosis score \[F1, F2, F3\] and the dose group as factors.~P-values from the contrast tests corresponding to each dose response pattern evaluated were adjusted for the multiple comparisons performed."|||||<|0.0001|||||||MCP-Mod Emax1 model fit|Model assumption: 50% of maximum effect is achieved at dose 3.0 mg.||A flat vs. non-flat dose-response relationship across the 3 doses of survodutide and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 6 different plausible dose-response patterns (linear, exponential1, exponential2, Emax1, Emax2, quadratic) while keeping full control of the type I error (one-sided alpha of 0.050).||||<0.0001
72434289|NCT04771273|144381922|OTHER|"Logistic regression estimates were used as input for the MCP-Mod. The logistic regression model was fitted without an intercept and included presence of diabetes of any type \[yes, no\], baseline fibrosis score \[F1, F2, F3\] and the dose group as factors.~P-values from the contrast tests corresponding to each dose response pattern evaluated were adjusted for the multiple comparisons performed."|||||<|0.0001|||||||MCP-Mod Emax2 model fit|Model assumption: 80% of maximum effect is achieved at dose 3.0 mg.||A flat vs. non-flat dose-response relationship across the 3 doses of survodutide and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 6 different plausible dose-response patterns (linear, exponential1, exponential2, Emax1, Emax2, quadratic) while keeping full control of the type I error (one-sided alpha of 0.050).||||<0.0001
72434290|NCT04771273|144381922|OTHER|"Logistic regression estimates were used as input for the MCP-Mod. The logistic regression model was fitted without an intercept and included presence of diabetes of any type \[yes, no\], baseline fibrosis score \[F1, F2, F3\] and the dose group as factors.~P-values from the contrast tests corresponding to each dose response pattern evaluated were adjusted for the multiple comparisons performed."|||||<|0.0001|||||||MCP-Mod quadratic model fit|Model assumption: Maximum effect is achieved at dose 4.8 mg.||A flat vs. non-flat dose-response relationship across the 3 doses of survodutide and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 6 different plausible dose-response patterns (linear, exponential1, exponential2, Emax1, Emax2, quadratic) while keeping full control of the type I error (one-sided alpha of 0.050).||||<0.0001
72381880|NCT00591266|144272420|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.19|||<|0.001|TWO_SIDED|95.0|-13.29|-9.09||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented. Overall 0.05 level of significance for multiple comparisons controlled using closed testing procedure.|ANCOVA|||||-9.09|-13.29|<0.001
72434291|NCT04771273|144381923|OTHER|No confirmatory hypothesis testing was performed.|Odds Ratio (OR)|5.49|||<|0.0001|TWO_SIDED|95.0|2.46|12.28||The p-value reported is considered nominal.|Regression, Logistic||Survodutide 2.4 mg vs. Placebo|The logistic regression model includes planned treatment, presence of diabetes of any type and Baseline Fibrosis Score. Firth's penalized regression was used.||12.28|2.46|<.0001
72434292|NCT04771273|144381923|OTHER|No confirmatory hypothesis testing was performed.|Odds Ratio (OR)|10.14|||<|0.0001|TWO_SIDED|95.0|4.49|22.87||The p-value reported is considered nominal.|Regression, Logistic||Survodutide 4.8 mg vs. Placebo|The logistic regression model includes planned treatment, presence of diabetes of any type and Baseline Fibrosis Score. Firth's penalized regression was used.||22.87|4.49|<.0001
72434293|NCT04771273|144381923|OTHER|No confirmatory hypothesis testing was performed.|Odds Ratio (OR)|4.87||||0.0001|TWO_SIDED|95.0|2.18|10.91||The p-value reported is considered nominal.|Regression, Logistic||Survodutide 6.0 mg vs. Placebo|The logistic regression model includes planned treatment, presence of diabetes of any type and Baseline Fibrosis Score. Firth's penalized regression was used.||10.91|2.18|0.0001
72434294|NCT04771273|144381923|OTHER|"Logistic regression estimates were used as input for the MCP-Mod. The logistic regression model was fitted without an intercept and included presence of diabetes of any type \[yes, no\], baseline fibrosis score \[F1, F2, F3\] and the dose group as factors.~P-values from the contrast tests corresponding to each dose response pattern evaluated were adjusted for the multiple comparisons performed."||||||0.0001|||||||MCPMod linear model fit|linear model fit assumption||A flat vs. non-flat dose-response relationship across the 3 doses of survodutide and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 6 different plausible dose-response patterns (linear, exponential1, exponential2, Emax1, Emax2, quadratic) while keeping full control of the type I error (one-sided alpha of 0.050).||||0.0001
72434295|NCT04771273|144381923|OTHER|"Logistic regression estimates were used as input for the MCP-Mod. The logistic regression model was fitted without an intercept, and included presence of diabetes of any type \[yes, no\], baseline fibrosis score \[F1, F2, F3\] and the dose group as factors.~P-values from the contrast tests corresponding to each dose response pattern evaluated were adjusted for the multiple comparisons performed."||||||0.0115|||||||MCPMod exponential-1 model fit|Model assumption: 25% of maximum effect is achieved at dose 3.0 mg.||A flat vs. non-flat dose-response relationship across the 3 doses of survodutide and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 6 different plausible dose-response patterns (linear, exponential1, exponential2, Emax1, Emax2, quadratic) while keeping full control of the type I error (one-sided alpha of 0.050).||||0.0115
72434296|NCT04771273|144381923|OTHER|"Logistic regression estimates were used as input for the MCP-Mod. The logistic regression model was fitted without an intercept, and included presence of diabetes of any type \[yes, no\], baseline fibrosis score \[F1, F2, F3\] and the dose group as factors.~P-values from the contrast tests corresponding to each dose response pattern evaluated were adjusted for the multiple comparisons performed."||||||0.2204|||||||MCP-Mod exponential-2 model fit|Model assumption: 5% of maximum effect is achieved at dose 3.0 mg.||A flat vs. non-flat dose-response relationship across the 3 doses of survodutide and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 6 different plausible dose-response patterns (linear, exponential1, exponential2, Emax1, Emax2, quadratic) while keeping full control of the type I error (one-sided alpha of 0.050).||||0.2204
72381881|NCT00591266|144272420|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.91|||<|0.001|TWO_SIDED|95.0|-13.0|-8.81||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented. Overall 0.05 level of significance for multiple comparisons controlled using closed testing procedure.|ANCOVA|||||-8.81|-13.00|<0.001
72381882|NCT00591266|144272421|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.02|||<|0.001|TWO_SIDED|95.0|-13.93|-8.1||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented. Overall 0.05 level of significance for multiple comparisons controlled using closed testing procedure.|ANCOVA|||||-8.10|-13.93|<0.001
72381883|NCT00591266|144272421|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.56|||<|0.001|TWO_SIDED|95.0|-12.48|-6.63||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented. Overall 0.05 level of significance for multiple comparisons controlled using closed testing procedure.|ANCOVA|||||-6.63|-12.48|<0.001
72381884|NCT00591266|144272422|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.48|||<|0.001|TWO_SIDED|95.0|-8.84|-6.11||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-6.11|-8.84|<0.001
72381885|NCT00591266|144272422|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.65|||<|0.001|TWO_SIDED|95.0|-9.01|-6.28||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-6.28|-9.01|<0.001
72381886|NCT00591266|144272423|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.93|||<|0.001|TWO_SIDED|95.0|-6.62|-3.23||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-3.23|-6.62|<0.001
72381887|NCT00591266|144272423|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.58|||<|0.001|TWO_SIDED|95.0|-7.28|-3.88||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-3.88|-7.28|<0.001
72381888|NCT00591266|144272424|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.64|||<|0.001|TWO_SIDED|95.0|-13.86|-9.41||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-9.41|-13.86|<0.001
72381889|NCT00591266|144272424|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.17|||<|0.001|TWO_SIDED|95.0|-13.39|-8.95||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-8.95|-13.39|<0.001
72381890|NCT00591266|144272425|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.99|||<|0.001|TWO_SIDED|95.0|-9.47|-6.5||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-6.50|-9.47|<0.001
72381891|NCT00591266|144272425|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.04|||<|0.001|TWO_SIDED|95.0|-9.52|-6.55||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-6.55|-9.52|<0.001
72381892|NCT00591266|144272426|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.7|||<|0.001|TWO_SIDED|95.0|-12.07|-7.34||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-7.34|-12.07|<0.001
72493966|NCT03728309|144516850|SUPERIORITY||Percentage Difference|53.5|||<|0.001|TWO_SIDED|95.0|43.5|63.5||The p-value and 95% CI are computed by pooling 30 imputed data sets using SAS PROC MIANALYZE with normal approximation.|SAS PROC MIANALYZE|||||63.5|43.5|<0.001
72381893|NCT00591266|144272426|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.67|||<|0.001|TWO_SIDED|95.0|-12.03|-7.31||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-7.31|-12.03|<0.001
72381894|NCT00591266|144272427|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.26|||<|0.001|TWO_SIDED|95.0|-7.94|-4.57||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-4.57|-7.94|<0.001
72381895|NCT00591266|144272427|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.28|||<|0.001|TWO_SIDED|95.0|-7.96|-4.6||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-4.60|-7.96|<0.001
72381896|NCT00591266|144272428|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.27|||<|0.001|TWO_SIDED|95.0|-14.63|-9.92||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-9.92|-14.63|<0.001
72381897|NCT00591266|144272428|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.58|||<|0.001|TWO_SIDED|95.0|-13.93|-9.23||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-9.23|-13.93|<0.001
72381898|NCT00591266|144272429|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.39|||<|0.001|TWO_SIDED|95.0|-9.98|-6.79||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-6.79|-9.98|<0.001
72381899|NCT00591266|144272429|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.23|||<|0.001|TWO_SIDED|95.0|-9.82|-6.64||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-6.64|-9.82|<0.001
72381900|NCT00591266|144272430|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.83|||<|0.001|TWO_SIDED|95.0|-11.45|-6.22||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-6.22|-11.45|<0.001
72381901|NCT00591266|144272430|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.91|||<|0.001|TWO_SIDED|95.0|-11.51|-6.3||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-6.30|-11.51|<0.001
72381902|NCT00591266|144272431|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.94|||<|0.001|TWO_SIDED|95.0|-7.88|-4.0||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-4.00|-7.88|<0.001
72556941|NCT03131895|144645238|EQUIVALENCE|A linear mixed effect model on the natural log-transformed parameters was performed with regimen, sequence and period as a fixed effect and subject nested within sequence as a random effect. The least squares means and difference of least squares means for the log-transformed parameters were exponentiated to obtain the point estimates and 90% CIs on the original scale.|LS mean ratio|1.0353||||0.3896|TWO_SIDED|90.0|0.9719|1.1029|||ANOVA|||||1.1029|0.9719|0.3896
72556942|NCT03131895|144645239|EQUIVALENCE|A linear mixed effect model on the natural log-transformed parameters was performed with regimen, sequence and period as a fixed effect and subject nested within sequence as a random effect. The least squares means and difference of least squares means for the log-transformed parameters were exponentiated to obtain the point estimates and 90% CIs on the original scale.|LS mean ratio|1.0335||||0.4163|TWO_SIDED|90.0|0.9733|1.0975|||ANOVA|||||1.0975|0.9733|0.4163
72556943|NCT03131895|144645239|EQUIVALENCE|A linear mixed effect model on the natural log-transformed parameters was performed with regimen, sequence and period as a fixed effect and subject nested within sequence as a random effect. The least squares means and difference of least squares means for the log-transformed parameters were exponentiated to obtain the point estimates and 90% CIs on the original scale.|LS mean ratio|1.0031||||0.9778|TWO_SIDED|90.0|0.9458|1.0638|||ANOVA|||||1.0638|0.9458|0.9778
72556944|NCT00540423|144645240|SUPERIORITY_OR_OTHER||Risk Difference (RD)|60.0||||||95.0|35.21|84.79|||||The units of risk difference is percentage.|||84.79|35.21|
72556945|NCT00540423|144645242|SUPERIORITY_OR_OTHER||Percentage of 75% responders|43.5||||||95.0|23.19|65.51|||||Confidence interval of the percentage of participants for whom at least 75% of their assessments during the course of 26 weeks of SB-494115-GR treatment met the definition of responders.|||65.51|23.19|
72618651|NCT01026038|144768107|SUPERIORITY_OR_OTHER||GMC ratio|1.25|||||TWO_SIDED|95.0|0.42|3.72||||||Serotype 14: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||3.72|0.42|
72381903|NCT00591266|144272431|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.54|||<|0.001|TWO_SIDED|95.0|-8.47|-4.61||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-4.61|-8.47|<0.001
72381904|NCT00591266|144272432|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.37|||<|0.001|TWO_SIDED|95.0|2.15|5.26||P-value for response criteria for systolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value is presented.|Regression, Logistic|||||5.26|2.15|<0.001
72381905|NCT00591266|144272432|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.21|||<|0.001|TWO_SIDED|95.0|2.05|5.03||P-value for response criteria for systolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value is presented.|Regression, Logistic|||||5.03|2.05|<0.001
72434297|NCT04771273|144381923|OTHER|"Logistic regression estimates were used as input for the MCP-Mod. The logistic regression model was fitted without an intercept, and included presence of diabetes of any type \[yes, no\], baseline fibrosis score \[F1, F2, F3\] and the dose group as factors.~P-values from the contrast tests corresponding to each dose response pattern evaluated were adjusted for the multiple comparisons performed."|||||<|0.0001|||||||MCP-Mod Emax1 model fit|Model assumption: 50% of maximum effect is achieved at dose 3.0 mg.||A flat vs. non-flat dose-response relationship across the 3 doses of survodutide and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 6 different plausible dose-response patterns (linear, exponential1, exponential2, Emax1, Emax2, quadratic) while keeping full control of the type I error (one-sided alpha of 0.050).||||<0.0001
72556946|NCT05143047|144645294|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
72556947|NCT05143047|144645295|SUPERIORITY|||||||0.04|||||||t-test, 2 sided|||||||0.04
72556948|NCT05143047|144645296|SUPERIORITY|||||||0.42|||||||Fisher Exact|||||||0.42
72556949|NCT05143047|144645297|SUPERIORITY|||||||0.17|||||||Fisher Exact|||||||0.17
72556950|NCT05143047|144645298|SUPERIORITY|||||||0.03|||||||Fisher Exact|||||||0.03
72556951|NCT05143047|144645299|SUPERIORITY|||||||0.42|||||||Fisher Exact|||||||0.42
72556952|NCT05143047|144645300|SUPERIORITY|||||||0.04|||||||Fisher Exact|||||||0.04
72556953|NCT05143047|144645301|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||<0.001
72556954|NCT05143047|144645302|SUPERIORITY|||||||0.22|||||||Fisher Exact|||||||0.22
72556955|NCT00909753|144645307|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of Variance (ANOVA) will be applied to log-transformed AUC and Cmax parameters.|Geometric Test/Ref Ratio x 100|92.5||||||90.0|85.8|99.7|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||99.7|85.8|
72556956|NCT00909753|144645308|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of Variance (ANOVA) will be applied to log-transformed AUC and Cmax parameters.|Geometric Test/Ref Ratio x 100|95.5||||||90.0|92.2|98.9|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||98.9|92.2|
72556957|NCT00909753|144645309|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of Variance (ANOVA) will be applied to log-transformed AUC and Cmax parameters.|Geometric Test/Ref Ratio x 100|90.4||||||90.0|83.1|98.3|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||98.3|83.1|
72556958|NCT00909753|144645310|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of Variance (ANOVA) will be applied to log-transformed AUC and Cmax parameters.|Geometric Test/Ref Ratio x 100|90.5||||||90.0|85.5|95.9|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||95.9|85.5|
72556959|NCT00909753|144645311|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of Variance (ANOVA) will be applied to log-transformed AUC and Cmax parameters.|Geometric Test/Ref Ratio x 100|92.2||||||90.0|85.5|99.5|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||99.5|85.5|
72556960|NCT00909753|144645312|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of Variance (ANOVA) will be applied to log-transformed AUC and Cmax parameters.|Geometric Test/Ref Ratio x 100|95.0||||||90.0|91.3|98.7|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||98.7|91.3|
72556961|NCT00909753|144645313|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of Variance (ANOVA) will be applied to log-transformed AUC and Cmax parameters.|Geometric Test/Ref Ratio x 100|90.4||||||90.0|83.1|98.3|||||Bioequivalence is established when 90% COnfidence Interval falls within 80-125.|||98.3|83.1|
72493967|NCT03728309|144516852|SUPERIORITY||Mean Difference (Final Values)|28.0|STANDARD_ERROR_OF_MEAN|3.83|<|0.001|TWO_SIDED|95.0|21.0|36.0|||2-sample, t-test|||||36.0|21.0|<0.001
72381906|NCT00591266|144272433|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.54|||<|0.001|TWO_SIDED|95.0|2.08|6.02||P-value for response criteria for diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic diastolic blood pressure as a covariate. The unadjusted p-value is presented.|Regression, Logistic|||||6.02|2.08|<0.001
72381907|NCT00591266|144272433|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.9|||<|0.001|TWO_SIDED|95.0|2.25|6.75||P-value for response criteria for diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic diastolic blood pressure as a covariate. The unadjusted p-value is presented.|Regression, Logistic|||||6.75|2.25|<0.001
72381908|NCT00591266|144272434|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.62|||<|0.001|TWO_SIDED|95.0|1.71|4.02||P-value for joint response criteria for systolic blood pressure and diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value is presented.|Regression, Logistic|||||4.02|1.71|<0.001
72381909|NCT00591266|144272434|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.12|||<|0.001|TWO_SIDED|95.0|2.01|4.82||P-value for joint response criteria for systolic blood pressure and diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value is presented.|Regression, Logistic|||||4.82|2.01|<0.001
72381910|NCT01226043|144272486|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.3|||<|0.0001|TWO_SIDED|95.0|2.15|2.44|||ANOVA|The last observation carried forward (LOCF) method was applied to impute missing Week 4 overall patient preference values for ANOVA analysis.||The hypothesis was to determine whether patients have higher preference score for Lantus® SoloSTAR® pen compared to Lantus® vial/syringe. Differences of patient preference score greater than 0.5 were considered clinically meaningful. The power for detecting a true difference of 0.5 considering a standard deviation from 1.6 to 2.5, assuming 130 evaluable patients per arm and a two-sided test at 0.05 significance level ranged from 89% to more than 99%.||2.44|2.15|<0.0001
72381911|NCT00910988|144272498|SUPERIORITY_OR_OTHER|||||||0.001||95.0||||This p-value corresponds to the two way interaction between time and order and is not adjusted for multiple comparisons. The a priori threshold for statistical significance is alpha equal to 0.05. There was no 3 way interaction.|ANCOVA|Repeated measures ANCOVA with time as the repeated measure, drug assignment as a fixed factor, and order as a fixed factor.||The hypothesis being tested is whether there is a significant effect of one or both antipsychotics on whole body insulin sensitivity. Sample size was calculated using power calculations to detect significant effects of treatment on insulin sensitivity. Drug assignment is a 2-level fixed factor (olanzapine vs ziprasidone) as is order (drug first vs placebo first). Baseline of the dependent variable as well as baseline DEXA total fat were entered into the model as covariates.||||0.001
72381912|NCT00910988|144272501|SUPERIORITY_OR_OTHER|||||||0.57|TWO_SIDED|95.0||||This p-value corresponds to the 3 way interaction between time, drug (olanzapine vs ziprasidone), and order (drug first vs placebo first) and is not adjusted for multiple comparisons.|ANCOVA|||The null hypothesis is that olanzapine and ziprasidone would result in acute decreases in insulin sensitivity compared to placebo at adipose tissue, which was measured by evaluating the rate of appearance of labeled glycerol. The alternative hypothesis is that olanzapine, but not ziprasidone, would result in acute decreases in insulin sensitivity compared to placebo at adipose tissue.||||0.57
72381913|NCT00191646|144272559|SUPERIORITY_OR_OTHER|||||||0.199||95.0|||||Log Rank|||Using a two-sided log-rank test with a Type I error of 0.05, 636 events for PFS out of the 919 patients would give an 80% statistical power under the alternative hypothesis that the hazard ratio of the G/C arm versus the P/C arm was 0.08.||||0.199
72381914|NCT00191646|144272560|SUPERIORITY_OR_OTHER|||||||0.771||95.0|||||Fisher Exact|||||||0.771
72381915|NCT00191646|144272560|SUPERIORITY_OR_OTHER|||||||0.784||95.0|||||Fisher Exact|||||||0.784
72381916|NCT00191646|144272561|SUPERIORITY_OR_OTHER|||||||0.621||95.0|||||Log Rank|||||||0.621
72381917|NCT00191646|144272562|SUPERIORITY_OR_OTHER|||||||0.013||95.0|||||Log Rank|||||||0.013
72381918|NCT03911843|144272595|SUPERIORITY||Mean Difference (Net)|-0.14|||<|0.05|TWO_SIDED|95.0||||the p-value of significance was calculated using the analysis system|Wilcoxon (Mann-Whitney)|||||||<0.05
72381919|NCT03911843|144272595|SUPERIORITY||Mean Difference (Net)|-0.14|||<|0.05|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.05
72381920|NCT03911843|144272596|SUPERIORITY||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
72381921|NCT03911843|144272597|SUPERIORITY||||||<|0.05|TWO_SIDED|95.0|||||Chi-squared|||||||<0.05
72381922|NCT01907100|144272598|OTHER||Hazard Ratio (HR)|0.555||||0.0174|TWO_SIDED|95.0|0.34|0.907|||Proportional hazards mode||Hazard ratio, confidence interval and p-value obtained from proportional hazards model stratified by tumour histology (epithelioid vs. biphasic).|Phase II Part||0.907|0.340|0.0174
72381923|NCT01907100|144272598|OTHER||Hazard Ratio (HR)|1.01||||0.543|TWO_SIDED|95.0|0.79|1.3||one-sided p-value|Proportional hazards model||Hazard ratio, confidence interval and p-value obtained from a non-stratified proportional hazards model.|"Phase III part:~A Cox proportional hazards model was fitted to estimate hazard ratios (HRs) and corresponding 95% confidence intervals (CIs) for the comparison of treatment arms (Nintedanib vs Placebo).~If the hazard ratio is below 1 then it favours nintedanib."||1.30|0.79|0.5430
72381924|NCT01907100|144272599|OTHER||Hazard Ratio (HR)|0.782||||0.4132|TWO_SIDED|95.0|0.433|1.412|||Proportional hazards mode||Hazard ratio, confidence interval and p-value obtained from proportional hazards model stratified by tumour histology (epithelioid vs. biphasic).|Phase II||1.412|0.433|0.4132
72381925|NCT01907100|144272599|OTHER||Hazard Ratio (HR)|1.12||||0.7306|TWO_SIDED|95.0|0.79|1.58||one-sided p-value|Proportional hazards model||Hazard ratio, confidence interval and p-value obtained from a non-stratified proportional hazards model.|"Phase III:~A Cox proportional hazards model was fitted to estimate hazard ratios (HRs) and corresponding 95% confidence intervals (CIs) for the comparison of treatment arms (Nintedanib vs Placebo).~If the hazard ratio is below 1 then it favours nintedanib."||1.58|0.79|0.7306
72381926|NCT01907100|144272600|OTHER||Odds Ratio (OR)|1.09||||0.3189|TWO_SIDED|95.0|0.76|1.58||one-sided p-value|Regression, Logistic|Odds ratio and one-sided p-value are obtained from an un-adjusted logistic regression model (Nintedanib vs Placebo).|Odds ratio above 1 favours nintedanib.||Exact 95% CI by Clopper and Pearson.|1.58|0.76|0.3189
72381927|NCT01907100|144272601|OTHER||Odds Ratio (OR)|0.79||||0.7512|TWO_SIDED|95.0|0.4|1.55||one-sided p-value|Regression, Logistic|Odds ratio and one-sided p-value are obtained from an un-adjusted logistic regression model (Nintedanib vs Placebo).|Odds ratio above 1 favours nintedanib.|||1.55|0.40|0.7512
72434298|NCT04771273|144381923|OTHER|"Logistic regression estimates were used as input for the MCP-Mod. The logistic regression model was fitted without an intercept and included presence of diabetes of any type \[yes, no\], baseline fibrosis score \[F1, F2, F3\] and the dose group as factors.~P-values from the contrast tests corresponding to each dose response pattern evaluated were adjusted for the multiple comparisons performed."|||||<|0.0001|||||||MCP-Mod Emax2|Model assumption: 80% of maximum effect is achieved at dose 3.0 mg.||A flat vs. non-flat dose-response relationship across the 3 doses of survodutide and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 6 different plausible dose-response patterns (linear, exponential1, exponential2, Emax1, Emax2, quadratic) while keeping full control of the type I error (one-sided alpha of 0.050).||||<0.0001
72381928|NCT01298544|144272618|SUPERIORITY_OR_OTHER||Ratio of GMCs|0.68|||||TWO_SIDED|95.0|0.48|0.94|||||Calculated by back transforming the ratio difference between vaccine groups on logarithmic scale. Back transformations of CIs based on Student t distribution for ratio difference of the logarithms of the measures (Group 2-Group 1).|Serotype 4||0.94|0.48|
72381929|NCT01298544|144272618|SUPERIORITY_OR_OTHER||Ratio of GMCs|0.81|||||TWO_SIDED|95.0|0.64|1.04|||||Calculated by back transforming the ratio difference between vaccine groups on logarithmic scale. Back transformations of CIs based on Student t distribution for ratio difference of the logarithms of the measures (Group 2-Group 1).|Serotype 6B||1.04|0.64|
72381930|NCT01298544|144272618|SUPERIORITY_OR_OTHER||Ratio of GMCs|0.95|||||TWO_SIDED|95.0|0.74|1.23|||||Calculated by back transforming the ratio difference between vaccine groups on logarithmic scale. Back transformations of CIs based on Student t distribution for ratio difference of the logarithms of the measures (Group 2-Group 1).|Serotype 9V||1.23|0.74|
72381931|NCT01298544|144272618|SUPERIORITY_OR_OTHER||Ratio of GMCs|0.67|||||TWO_SIDED|95.0|0.45|1.01|||||Calculated by back transforming the ratio difference between vaccine groups on logarithmic scale. Back transformations of CIs based on Student t distribution for ratio difference of the logarithms of the measures (Group 2-Group 1).|Serotype 14||1.01|0.45|
72434299|NCT04771273|144381923|OTHER|"Logistic regression estimates were used as input for the MCP-Mod. The logistic regression model was fitted without an intercept, and included presence of diabetes of any type \[yes, no\], baseline fibrosis score \[F1, F2, F3\] and the dose group as factors.~P-values from the contrast tests corresponding to each dose response pattern evaluated were adjusted for the multiple comparisons performed."|||||<|0.0001|||||||MCP-Mod quadratic model fit|Model assumption: Maximum effect is achieved at dose 4.8 mg.||A flat vs. non-flat dose-response relationship across the 3 doses of survodutide and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 6 different plausible dose-response patterns (linear, exponential1, exponential2, Emax1, Emax2, quadratic) while keeping full control of the type I error (one-sided alpha of 0.050).||||<0.0001
72434300|NCT04771273|144381924|OTHER|No confirmatory hypothesis testing was performed.|Odds Ratio (OR)|5.07|||<|0.0001|TWO_SIDED|95.0|2.47|10.4||The p-value reported is considered nominal.|Regression, Logistic||Survodutide 2.4 mg vs. Placebo|The logistic regression model included actual treatment, presence of diabetes of any type, baseline liver fat content and baseline fibrosis score. Firth's penalized regression was used.||10.40|2.47|<.0001
72434301|NCT04771273|144381924|OTHER|No confirmatory hypothesis testing was performed.|Odds Ratio (OR)|9.46|||<|0.0001|TWO_SIDED|95.0|4.36|20.51||The p-value reported is considered nominal.|Regression, Logistic||Survodutide 4.8 mg vs. Placebo|The logistic regression model included actual treatment, presence of diabetes of any type, baseline liver fat content and baseline fibrosis score. Firth's penalized regression was used.||20.51|4.36|<.0001
72381932|NCT01298544|144272618|SUPERIORITY_OR_OTHER||Ratio of GMCs|0.96|||||TWO_SIDED|95.0|0.7|1.31|||||Calculated by back transforming the ratio difference between vaccine groups on logarithmic scale. Back transformations of CIs based on Student t distribution for ratio difference of the logarithms of the measures (Group 2-Group 1).|Serotype 18C||1.31|0.70|
72381933|NCT01298544|144272618|SUPERIORITY_OR_OTHER||Ratio of GMCs|0.56|||||TWO_SIDED|95.0|0.4|0.77|||||Calculated by back transforming the ratio difference between vaccine groups on logarithmic scale. Back transformations of CIs based on Student t distribution for ratio difference of the logarithms of the measures (Group 2-Group 1).|Serotype 19F||0.77|0.40|
72381934|NCT01298544|144272618|SUPERIORITY_OR_OTHER||Ratio of GMCs|0.82|||||TWO_SIDED|95.0|0.64|1.05|||||Calculated by back transforming the ratio difference between vaccine groups on logarithmic scale. Back transformations of CIs based on Student t distribution for ratio difference of the logarithms of the measures (Group 2-Group 1).|Serotype 23F||1.05|0.64|
72381935|NCT01298544|144272618|SUPERIORITY_OR_OTHER||Ratio of GMCs|1.97|||||TWO_SIDED|95.0|1.39|2.8|||||Calculated by back transforming the ratio difference between vaccine groups on logarithmic scale. Back transformations of CIs based on Student t distribution for ratio difference of the logarithms of the measures (Groups 1 and 2 combined-Group 3).|Serotype 4||2.80|1.39|
72381936|NCT01298544|144272618|SUPERIORITY_OR_OTHER||Ratio of GMCs|3.04|||||TWO_SIDED|95.0|2.41|3.84|||||Calculated by back transforming the ratio difference between vaccine groups on logarithmic scale. Back transformations of CIs based on Student t distribution for ratio difference of the logarithms of the measures (Groups 1 and 2 combined-Group 3).|Serotype 6B||3.84|2.41|
72434302|NCT04771273|144381924|OTHER|No confirmatory hypothesis testing was performed.|Odds Ratio (OR)|16.09|||<|0.0001|TWO_SIDED|95.0|6.69|38.73||The p-value reported is considered nominal.|Regression, Logistic||Survodutide 6.0 mg vs. Placebo|The logistic regression model included actual treatment, presence of diabetes of any type, baseline liver fat content and baseline fibrosis score. Firth's penalized regression was used.||38.73|6.69|<.0001
72493968|NCT03728309|144516853|SUPERIORITY||Percentage Difference|52.9|||<|0.001|TWO_SIDED|95.0|40.1|65.7|||Fisher's Exact Test||Comparison of treatment group versus control group at Month 1, responder rate difference, 95% CI for risk difference and p-value was estimated based on Fisher's exact test using mITT population with baseline AFLS score of 2 or 3 on both cheeks.|||65.7|40.1|<0.001
72493969|NCT01849770|144516922|SUPERIORITY_OR_OTHER_LEGACY||Slope|-0.23|STANDARD_ERROR_OF_MEAN|0.4||0.561|TWO_SIDED|95.0|-1.03|0.56|||Random slopes model|||||0.56|-1.03|0.561
72493970|NCT01849770|144516922|SUPERIORITY_OR_OTHER_LEGACY||Slope|-0.19|STANDARD_ERROR_OF_MEAN|0.43||0.662|TWO_SIDED|95.0|-1.04|0.66|||Random slopes model|||||0.66|-1.04|0.662
72434303|NCT04771273|144381924|OTHER|"Logistic regression estimates were used as input for the MCP-Mod. The logistic regression model was fitted without an intercept and included presence of diabetes of any type \[yes, no\], baseline fibrosis score \[F1, F2, F3\] and the dose group as factors, and baseline liver fat content (assessed by MRI-PDFF) as a continuous linear covariate.~P-values from the contrast tests corresponding to each dose response pattern evaluated were adjusted for the multiple comparisons performed."|||||<|0.0001|||||||MCP-Mod linear model fit|Linear model fit assumption||A flat vs. non-flat dose-response relationship across the 3 doses of survodutide and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 6 different plausible dose-response patterns (linear, exponential1, exponential2, Emax1, Emax2, quadratic) while keeping full control of the type I error (one-sided alpha of 0.050).||||<0.0001
72434304|NCT04771273|144381924|OTHER|"Logistic regression estimates were used as input for the MCP-Mod. The logistic regression model was fitted without an intercept and included presence of diabetes of any type \[yes, no\], baseline fibrosis score \[F1, F2, F3\] and the dose group as factors, and baseline liver fat content (assessed by MRI-PDFF) as a continuous linear covariate.~P-values from the contrast tests corresponding to each dose response pattern evaluated were adjusted for the multiple comparisons performed."|||||<|0.0001|||||||MCP-Mod exponential-1 model fit|Model assumption: 25% of maximum effect is achieved at dose 3.0 mg.||A flat vs. non-flat dose-response relationship across the 3 doses of survodutide and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 6 different plausible dose-response patterns (linear, exponential1, exponential2, Emax1, Emax2, quadratic) while keeping full control of the type I error (one-sided alpha of 0.050).||||<0.0001
72434305|NCT04771273|144381924|OTHER|"Logistic regression estimates were used as input for the MCP-Mod. The logistic regression model was fitted without an intercept, and included presence of diabetes of any type \[yes, no\], baseline fibrosis score \[F1, F2, F3\] and the dose group as factors, and baseline liver fat content (assessed by MRI-PDFF) as a continuous linear covariate.~P-values from the contrast tests corresponding to each dose response pattern evaluated were adjusted for the multiple comparisons performed."|||||<|0.0001|||||||MCP-Mod exponential-2 model fit|Model assumption: 5% of maximum effect achieved at dose 3.0 mg.||A flat vs. non-flat dose-response relationship across the 3 doses of survodutide and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 6 different plausible dose-response patterns (linear, exponential1, exponential2, Emax1, Emax2, quadratic) while keeping full control of the type I error (one-sided alpha of 0.050).||||<0.0001
72434306|NCT04771273|144381924|OTHER|"Logistic regression estimates were used as input for the MCP-Mod. The logistic regression model was fitted without an intercept and included presence of diabetes of any type \[yes, no\], baseline fibrosis score \[F1, F2, F3\] and the dose group as factors, and baseline liver fat content (assessed by MRI-PDFF) as a continuous linear covariate.~P-values from the contrast tests corresponding to each dose response pattern evaluated were adjusted for the multiple comparisons performed."|||||<|0.0001|||||||MCP-Mod Emax1 model fit|Model assumption: 50% of maximum effect is achieved at dose 3.0 mg.||A flat vs. non-flat dose-response relationship across the 3 doses of survodutide and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 6 different plausible dose-response patterns (linear, exponential1, exponential2, Emax1, Emax2, quadratic) while keeping full control of the type I error (one-sided alpha of 0.050).||||<0.0001
72434307|NCT04771273|144381924|OTHER|"Logistic regression estimates were used as input for the MCP-Mod. The logistic regression model was fitted without an intercept, and included presence of diabetes of any type \[yes, no\], baseline fibrosis score \[F1, F2, F3\] and the dose group as factors, and baseline liver fat content (assessed by MRI-PDFF) as a continuous linear covariate.~P-values from the contrast tests corresponding to each dose response pattern evaluated were adjusted for the multiple comparisons performed."|||||<|0.0001|||||||MCP-Mod Emax2 model fit|Model assumption: 80% of maximum effect is achieved at dose 3.0 mg.||A flat vs. non-flat dose-response relationship across the 3 doses of survodutide and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 6 different plausible dose-response patterns (linear, exponential1, exponential2, Emax1, Emax2, quadratic) while keeping full control of the type I error (one-sided alpha of 0.050).||||<0.0001
72434308|NCT04771273|144381924|OTHER|"Logistic regression estimates were used as input for the MCP-Mod. The logistic regression model was fitted without an intercept and included presence of diabetes of any type \[yes, no\], baseline fibrosis score \[F1, F2, F3\] and the dose group as factors, and baseline liver fat content (assessed by MRI-PDFF) as a continuous linear covariate.~P-values from the contrast tests corresponding to each dose response pattern evaluated were adjusted for the multiple comparisons performed."|||||<|0.0001|||||||MCP-Mod quadratic model fit|Model assumption: Maximum effect is achieved at dose 4.8 mg.||A flat vs. non-flat dose-response relationship across the 3 doses of survodutide and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 6 different plausible dose-response patterns (linear, exponential1, exponential2, Emax1, Emax2, quadratic) while keeping full control of the type I error (one-sided alpha of 0.050).||||<0.0001
72434309|NCT04771273|144381925|OTHER|No confirmatory hypothesis testing was performed.|Odds Ratio (OR)|10.39|||<|0.0001|TWO_SIDED|95.0|4.6|23.45||The p-value reported is considered nominal.|Regression, Logistic||Survodutide 2.4 mg vs. Placebo|The logistic regression model included planned treatment, presence of diabetes of any type, baseline liver fat content and baseline fibrosis score. Firth's penalized regression was used.||23.45|4.60|<.0001
72434310|NCT04771273|144381925|OTHER|No confirmatory hypothesis testing was performed.|Odds Ratio (OR)|12.06|||<|0.0001|TWO_SIDED|95.0|5.3|27.45||The p-value reported is considered nominal.|Regression, Logistic||Survodutide 4.8 mg vs. Placebo|The logistic regression model included planned treatment, presence of diabetes of any type, baseline liver fat content and baseline fibrosis score. Firth's penalized regression was used.||27.45|5.30|<.0001
72493971|NCT01849770|144516923|SUPERIORITY_OR_OTHER_LEGACY||Slope|1.71|STANDARD_ERROR_OF_MEAN|1.25||0.178|TWO_SIDED|95.0|-0.8|4.22|||Random slopes model|||||4.22|-0.80|0.178
72493972|NCT01849770|144516923|SUPERIORITY_OR_OTHER_LEGACY||Slope|-0.94|STANDARD_ERROR_OF_MEAN|1.42||0.51|TWO_SIDED|95.0|-3.8|1.91|||Random slopes model|||||1.91|-3.80|0.510
72493973|NCT00993031|144516929|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.83||||0.76|TWO_SIDED|95.0|0.26|2.67|||Chi-squared|||||2.67|.26|.76
72493974|NCT00993031|144516930|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.85||||0.76|TWO_SIDED|95.0|0.29|2.46|||Chi-squared|||||2.46|.29|.76
72618652|NCT01026038|144768107|SUPERIORITY_OR_OTHER||GMC ratio|0.69|||||TWO_SIDED|95.0|0.29|1.68||||||Serotype 18C: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||1.68|0.29|
72434311|NCT04771273|144381925|OTHER|No confirmatory hypothesis testing was performed.|Odds Ratio (OR)|8.22|||<|0.0001|TWO_SIDED|95.0|3.66|18.5||The p-value reported is considered nominal.|Regression, Logistic||Survodutide 6.0 mg vs. Placebo|The logistic regression model included planned treatment, presence of diabetes of any type, baseline liver fat content and baseline fibrosis score. Firth's penalized regression was used.||18.50|3.66|<.0001
72434312|NCT04771273|144381925|OTHER|"Logistic regression estimates were used as input for the MCP-Mod. The logistic regression model was fitted without an intercept, and included presence of diabetes of any type \[yes, no\], baseline fibrosis score \[F1, F2, F3\] and the dose group as factors, and baseline liver fat content (assessed by MRI-PDFF) as a continuous linear covariate.~P-values from the contrast tests corresponding to each dose response pattern evaluated were adjusted for the multiple comparisons performed."|||||<|0.0001|||||||MCP-Mod linear model fit|Linear model fit assumption.||A flat vs. non-flat dose-response relationship across the 3 doses of survodutide and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 6 different plausible dose-response patterns (linear, exponential1, exponential2, Emax1, Emax2, quadratic) while keeping full control of the type I error (one-sided alpha of 0.050).||||<0.0001
72434313|NCT04771273|144381925|OTHER|"Logistic regression estimates were used as input for the MCP-Mod. The logistic regression model was fitted without an intercept and included presence of diabetes of any type \[yes, no\], baseline fibrosis score \[F1, F2, F3\] and the dose group as factors, and baseline liver fat content (assessed by MRI-PDFF) as a continuous linear covariate.~P-values from the contrast tests corresponding to each dose response pattern evaluated were adjusted for the multiple comparisons performed."||||||0.0031|||||||MCP-Mod exponential-1 model fit|Model assumption: 25% of maximum effect is achieved at dose 3.0 mg.||A flat vs. non-flat dose-response relationship across the 3 doses of survodutide and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 6 different plausible dose-response patterns (linear, exponential1, exponential2, Emax1, Emax2, quadratic) while keeping full control of the type I error (one-sided alpha of 0.050).||||0.0031
72434314|NCT04771273|144381925|OTHER|"Logistic regression estimates were used as input for the MCP-Mod. The logistic regression model was fitted without an intercept and included presence of diabetes of any type \[yes, no\], baseline fibrosis score \[F1, F2, F3\] and the dose group as factors, and baseline liver fat content (assessed by MRI-PDFF) as a continuous linear covariate.~P-values from the contrast tests corresponding to each dose response pattern evaluated were adjusted for the multiple comparisons performed."||||||0.0925|||||||MCP-Mod exponential-2 model fit|Model assumption: 5% of maximum effect is achieved at dose 3.0 mg.||A flat vs. non-flat dose-response relationship across the 3 doses of survodutide and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 6 different plausible dose-response patterns (linear, exponential1, exponential2, Emax1, Emax2, quadratic) while keeping full control of the type I error (one-sided alpha of 0.050).||||0.0925
72434315|NCT04771273|144381925|OTHER|"Logistic regression estimates were used as input for the MCP-Mod. The logistic regression model was fitted without an intercept and included presence of diabetes of any type \[yes, no\], baseline fibrosis score \[F1, F2, F3\] and the dose group as factors, and baseline liver fat content (assessed by MRI-PDFF) as a continuous linear covariate.~P-values from the contrast tests corresponding to each dose response pattern evaluated were adjusted for the multiple comparisons performed."|||||<|0.0001|||||||MCP-Mod Emax1 model fit|Model assumption: 50% of maximum effect is achieved at dose 3.0 mg.||A flat vs. non-flat dose-response relationship across the 3 doses of survodutide and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 6 different plausible dose-response patterns (linear, exponential1, exponential2, Emax1, Emax2, quadratic) while keeping full control of the type I error (one-sided alpha of 0.050).||||<0.0001
72434316|NCT04771273|144381925|OTHER|"Logistic regression estimates were used as input for the MCP-Mod. The logistic regression model was fitted without an intercept and included presence of diabetes of any type \[yes, no\], baseline fibrosis score \[F1, F2, F3\] and the dose group as factors, and baseline liver fat content (assessed by MRI-PDFF) as a continuous linear covariate.~P-values from the contrast tests corresponding to each dose response pattern evaluated were adjusted for the multiple comparisons performed."|||||<|0.0001|||||||MCP-Mod Emax2 model fit|Model assumption: 80% of maximum effect is achieved at dose 3.0 mg.||A flat vs. non-flat dose-response relationship across the 3 doses of survodutide and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 6 different plausible dose-response patterns (linear, exponential1, exponential2, Emax1, Emax2, quadratic) while keeping full control of the type I error (one-sided alpha of 0.050).||||<0.0001
72434317|NCT04771273|144381925|OTHER|"Logistic regression estimates were used as input for the MCP-Mod. The logistic regression model was fitted without an intercept, and included presence of diabetes of any type \[yes, no\], baseline fibrosis score \[F1, F2, F3\] and the dose group as factors, and baseline liver fat content (assessed by MRI-PDFF) as a continuous linear covariate.~P-values from the contrast tests corresponding to each dose response pattern evaluated were adjusted for the multiple comparisons performed."|||||<|0.0001|||||||MCP-Mod quadratic model fit|Model assumption: Maximum effect is achieved at dose 4.8 mg.||A flat vs. non-flat dose-response relationship across the 3 doses of survodutide and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 6 different plausible dose-response patterns (linear, exponential1, exponential2, Emax1, Emax2, quadratic) while keeping full control of the type I error (one-sided alpha of 0.050).||||<0.0001
72493975|NCT00993031|144516931|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.75||||0.45|TWO_SIDED|95.0|0.36|1.59|||Chi-squared|||||1.59|.36|.45
72493976|NCT00993031|144516933|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.22||||0.21|TWO_SIDED|95.0|0.89|1.66|||Chi-squared|||||1.66|.89|.21
72618653|NCT01026038|144768107|SUPERIORITY_OR_OTHER||GMC ratio|0.92|||||TWO_SIDED|95.0|0.4|2.1||||||Serotype 18C: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||2.10|0.40|
72556962|NCT00909753|144645314|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of Variance (ANOVA) will be applied to log-transformed AUC and Cmax parameters.|Geometric Test/Ref Ratio x 100|90.5||||||90.0|85.0|96.3|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||96.3|85.0|
72556963|NCT03214588|144645326|SUPERIORITY||Least Squares Mean Difference|-0.00054|STANDARD_ERROR_OF_MEAN|0.000746|>|0.999|TWO_SIDED|90.0|-0.00179|0.0007||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA|||Change from Baseline at Week 12||0.00070|-0.00179|>0.999
72556964|NCT03214588|144645326|SUPERIORITY||Least Squares Mean Difference|-0.00069|STANDARD_ERROR_OF_MEAN|0.000616|>|0.999|TWO_SIDED|90.0|-0.00172|0.00033||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA|||Change from Baseline at Week 12||0.00033|-0.00172|>0.999
72556965|NCT03214588|144645327|SUPERIORITY||Least Squares Mean Difference|-0.87|STANDARD_ERROR_OF_MEAN|0.782||0.135|TWO_SIDED|90.0|-2.18|0.44||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA|||Change from Baseline at Week 2||0.44|-2.18|0.135
72556966|NCT03214588|144645327|SUPERIORITY||Least Squares Mean Difference|0.59|STANDARD_ERROR_OF_MEAN|0.64||0.818|TWO_SIDED|90.0|-0.48|1.66||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA|||Change from Baseline at Week 2||1.66|-0.48|0.818
72556967|NCT03214588|144645327|SUPERIORITY||Least Squares Mean Difference|0.18|STANDARD_ERROR_OF_MEAN|0.77||0.591|TWO_SIDED|90.0|-1.11|1.47||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA|||Change from Baseline at Week 7||1.47|-1.11|0.591
72618654|NCT01026038|144768107|SUPERIORITY_OR_OTHER||GMC ratio|1.33|||||TWO_SIDED|95.0|0.49|3.64||||||Serotype 18C: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||3.64|0.49|
72381937|NCT01298544|144272618|SUPERIORITY_OR_OTHER||Ratio of GMCs|1.26|||||TWO_SIDED|95.0|0.98|1.62|||||Calculated by back transforming the ratio difference between vaccine groups on logarithmic scale. Back transformations of CIs based on Student t distribution for ratio difference of the logarithms of the measures (Groups 1 and 2 combined-Group 3).|Serotype 9V||1.62|0.98|
72381938|NCT01298544|144272618|SUPERIORITY_OR_OTHER||Ratio of GMCs|6.66|||||TWO_SIDED|95.0|4.53|9.79|||||Calculated by back transforming the ratio difference between vaccine groups on logarithmic scale. Back transformations of CIs based on Student t distribution for ratio difference of the logarithms of the measures (Groups 1 and 2 combined-Group 3).|Serotype 14||9.79|4.53|
72381939|NCT01298544|144272618|SUPERIORITY_OR_OTHER||Ratio of GMCs|2.34|||||TWO_SIDED|95.0|1.68|3.24|||||Calculated by back transforming the ratio difference between vaccine groups on logarithmic scale. Back transformations of CIs based on Student t distribution for ratio difference of the logarithms of the measures (Groups 1 and 2 combined-Group 3).|Serotype 18C||3.24|1.68|
72381940|NCT01298544|144272618|SUPERIORITY_OR_OTHER||Ratio of GMCs|4.47|||||TWO_SIDED|95.0|3.29|6.07|||||Calculated by back transforming the ratio difference between vaccine groups on logarithmic scale. Back transformations of CIs based on Student t distribution for ratio difference of the logarithms of the measures (Groups 1 and 2 combined-Group 3).|Serotype 19F||6.07|3.29|
72434318|NCT04771273|144381926|OTHER|No confirmatory hypothesis testing was performed.|Mean Difference (Net)|-8.59|||<|0.0001|TWO_SIDED|95.0|-10.59|-6.6||The p-value reported is considered nominal.|MMRM||"Survodutide 2.4 mg - Placebo."|Least Squares Mean differences and 95% confidence interval were calculated from mixed-effect model for repeated measures (MMRM) including fixed effects for baseline liver fat content (%) as a continuous linear covariate, and treatment, presence of diabetes of any type \[yes, no\], baseline fibrosis score \[F1, F2, F3\], visit, treatment by visit interaction and baseline by visit interaction as factors.||-6.60|-10.59|<.0001
72493977|NCT00993031|144516934|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.34||||0.06|TWO_SIDED|95.0|0.98|1.83|||Chi-squared|||||1.83|.98|.06
72493978|NCT03506295|144516943|OTHER||Odds Ratio (OR)|0.496||||0.7878|TWO_SIDED|95.0|0.168|1.469|||Regression, Logistic|||||1.469|0.168|0.7878
72556968|NCT03214588|144645327|SUPERIORITY||Least Squares Mean Difference|0.36|STANDARD_ERROR_OF_MEAN|0.643||0.713|TWO_SIDED|90.0|-0.71|1.44||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA|||Change from Baseline at Week 7||1.44|-0.71|0.713
72556969|NCT03214588|144645327|SUPERIORITY||Least Squares Mean Difference|0.24|STANDARD_ERROR_OF_MEAN|0.822||0.616|TWO_SIDED|90.0|-1.13|1.62||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA|||Change from Baseline at Week 12||1.62|-1.13|0.616
72556970|NCT03214588|144645327|SUPERIORITY||Least Squares Mean Difference|0.37|STANDARD_ERROR_OF_MEAN|0.679||0.708|TWO_SIDED|90.0|-0.76|1.51||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA|||Change from Baseline at Week 12||1.51|-0.76|0.708
72556971|NCT03214588|144645328|SUPERIORITY||Least Squares Mean Difference|-0.00039|STANDARD_ERROR_OF_MEAN|0.000604||0.741|TWO_SIDED|90.0|-0.0014|0.00062||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA|||Change from Baseline at Week 2||0.00062|-0.00140|0.741
72556972|NCT03214588|144645328|SUPERIORITY||Least Squares Mean Difference|-0.00093|STANDARD_ERROR_OF_MEAN|0.000505||0.964|TWO_SIDED|90.0|-0.00177|-0.00008||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA|||Change from Baseline at Week 2||-0.00008|-0.00177|0.964
72556973|NCT03214588|144645328|SUPERIORITY||Least Squares Mean Difference|-0.00014|STANDARD_ERROR_OF_MEAN|0.000772||0.573|TWO_SIDED|90.0|-0.00143|0.00115||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA|||Change from Baseline at Week 7||0.00115|-0.00143|0.573
72556974|NCT03214588|144645328|SUPERIORITY||Least Squares Mean Difference|-0.00044|STANDARD_ERROR_OF_MEAN|0.000646||0.749|TWO_SIDED|90.0|-0.00152|0.00064||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA|||Change from Baseline at Week 7||0.00064|-0.00152|0.749
72618655|NCT01026038|144768107|SUPERIORITY_OR_OTHER||GMC ratio|1.7|||||TWO_SIDED|95.0|0.7|4.12||||||Serotype 19F: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||4.12|0.70|
72556975|NCT03214588|144645329|SUPERIORITY||Least Squares Mean Difference|0.03|STANDARD_ERROR_OF_MEAN|0.154||0.571|TWO_SIDED|90.0|-0.23|0.29||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA||MMRM ANCOVA with Baseline FARS ADL as a covariate; pooled site, visit, treatment, and ambulation status (randomization factor) as fixed factors; and treatment-by-visit and Baseline FARS ADL-by-visit interactions.|Change at Week 2, Cutting-Handling Utensils||0.29|-0.23|0.571
72556976|NCT03214588|144645329|SUPERIORITY||Least Squares Mean Difference|0.23|STANDARD_ERROR_OF_MEAN|0.126||0.963|TWO_SIDED|90.0|0.02|0.44||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA||MMRM ANCOVA with Baseline FARS ADL as a covariate; pooled site, visit, treatment, and ambulation status (randomization factor) as fixed factors; and treatment-by-visit and Baseline FARS ADL-by-visit interactions.|Change at Week 2, Cutting-Handling Utensils||0.44|0.02|0.963
72556977|NCT03214588|144645329|SUPERIORITY||Least Squares Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.165||0.515|TWO_SIDED|90.0|-0.27|0.28||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA||MMRM ANCOVA with Baseline FARS ADL as a covariate; pooled site, visit, treatment, and ambulation status (randomization factor) as fixed factors; and treatment-by-visit and Baseline FARS ADL-by-visit interactions.|Change at Week 7, Cutting-Handling Utensils||0.28|-0.27|0.515
72556978|NCT03214588|144645329|SUPERIORITY||Least Squares Mean Difference|0.31|STANDARD_ERROR_OF_MEAN|0.138||0.986|TWO_SIDED|90.0|0.08|0.54||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA||MMRM ANCOVA with Baseline FARS ADL as a covariate; pooled site, visit, treatment, and ambulation status (randomization factor) as fixed factors; and treatment-by-visit and Baseline FARS ADL-by-visit interactions.|Change at Week 7, Cutting-Handling Utensils||0.54|0.08|0.986
72556979|NCT03214588|144645329|SUPERIORITY||Least Squares Mean Difference|0.09|STANDARD_ERROR_OF_MEAN|0.162||0.718|TWO_SIDED|90.0|-0.18|0.37||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA||MMRM ANCOVA with Baseline FARS ADL as a covariate; pooled site, visit, treatment, and ambulation status (randomization factor) as fixed factors; and treatment-by-visit and Baseline FARS ADL-by-visit interactions.|Change at Week 12, Cutting-Handling Utensils||0.37|-0.18|0.718
72556980|NCT03214588|144645329|SUPERIORITY||Least Squares Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|0.133||0.986|TWO_SIDED|90.0|0.08|0.52||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA||MMRM ANCOVA with Baseline FARS ADL as a covariate; pooled site, visit, treatment, and ambulation status (randomization factor) as fixed factors; and treatment-by-visit and Baseline FARS ADL-by-visit interactions.|Change at Week 12, Cutting-Handling Utensils||0.52|0.08|0.986
72556981|NCT03214588|144645329|SUPERIORITY||Least Squares Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.148||0.153|TWO_SIDED|90.0|-0.4|0.09||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA||MMRM ANCOVA with Baseline FARS ADL as a covariate; pooled site, visit, treatment, and ambulation status (randomization factor) as fixed factors; and treatment-by-visit and Baseline FARS ADL-by-visit interactions.|Change at Week 2, Dressing||0.09|-0.40|0.153
72556982|NCT03214588|144645329|SUPERIORITY||Least Squares Mean Difference|0.13|STANDARD_ERROR_OF_MEAN|0.119||0.861|TWO_SIDED|90.0|-0.07|0.33||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA||MMRM ANCOVA with Baseline FARS ADL as a covariate; pooled site, visit, treatment, and ambulation status (randomization factor) as fixed factors; and treatment-by-visit and Baseline FARS ADL-by-visit interactions.|Change at Week 2, Dressing||0.33|-0.07|0.861
72556983|NCT03214588|144645329|SUPERIORITY||Least Squares Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.12||0.443|TWO_SIDED|90.0|-0.22|0.18||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA||MMRM ANCOVA with Baseline FARS ADL as a covariate; pooled site, visit, treatment, and ambulation status (randomization factor) as fixed factors; and treatment-by-visit and Baseline FARS ADL-by-visit interactions.|Change at Week 7, Dressing||0.18|-0.22|0.443
72556984|NCT03214588|144645329|SUPERIORITY||Least Squares Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.1||0.359|TWO_SIDED|90.0|-0.2|0.13||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA||MMRM ANCOVA with Baseline FARS ADL as a covariate; pooled site, visit, treatment, and ambulation status (randomization factor) as fixed factors; and treatment-by-visit and Baseline FARS ADL-by-visit interactions.|Change at Week 7, Dressing||0.13|-0.20|0.359
72556985|NCT03214588|144645329|SUPERIORITY||Least Squares Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.157||0.268|TWO_SIDED|90.0|-0.36|0.17||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA||MMRM ANCOVA with Baseline FARS ADL as a covariate; pooled site, visit, treatment, and ambulation status (randomization factor) as fixed factors; and treatment-by-visit and Baseline FARS ADL-by-visit interactions.|Change at Week 12, Dressing||0.17|-0.36|0.268
72556986|NCT03214588|144645329|SUPERIORITY||Least Squares Mean Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.129||0.411|TWO_SIDED|90.0|-0.24|0.19||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA||MMRM ANCOVA with Baseline FARS ADL as a covariate; pooled site, visit, treatment, and ambulation status (randomization factor) as fixed factors; and treatment-by-visit and Baseline FARS ADL-by-visit interactions.|Change at Week 12, Dressing||0.19|-0.24|0.411
72556987|NCT03214588|144645329|SUPERIORITY||Least Squares Mean Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.151||0.358|TWO_SIDED|90.0|-0.31|0.2||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA||MMRM ANCOVA with Baseline FARS ADL as a covariate; pooled site, visit, treatment, and ambulation status (randomization factor) as fixed factors; and treatment-by-visit and Baseline FARS ADL-by-visit interactions.|Change at Week 2, Personal Hygiene||0.20|-0.31|0.358
72493979|NCT02682901|144516976|SUPERIORITY|||||||0.603||||||Between treatment group (bromocriptine-QR vs. placebo) differences in change from baseline to week 24 was analyzed using Independent Samples T-tests. Means are statistically significantly different at the 5% level (P \< 0.05) two-sided.|t-test, 2 sided|||||||0.603
72381941|NCT01298544|144272618|SUPERIORITY_OR_OTHER||Ratio of GMCs|2.08|||||TWO_SIDED|95.0|1.65|2.63|||||Calculated by back transforming the ratio difference between vaccine groups on logarithmic scale. Back transformations of CIs based on Student t distribution for ratio difference of the logarithms of the measures (Groups 1 and 2 combined-Group 3).|Serotype 23F||2.63|1.65|
72381942|NCT01298544|144272619|SUPERIORITY_OR_OTHER||Difference in proportions|-18.5|||||TWO_SIDED|95.0|-29.4|-7.3|||||Difference in proportions, expressed as a percentage. Exact 2 sided CI for the difference in proportions (Group 2-Group 1), expressed as a percentage.|Serotype 4||-7.3|-29.4|
72381943|NCT01298544|144272619|SUPERIORITY_OR_OTHER||Difference in proportions|0.0|||||TWO_SIDED|95.0|-3.1|3.0|||||Difference in proportions, expressed as a percentage. Exact 2 sided CI for the difference in proportions (Group 2-Group 1), expressed as a percentage.|Serotype 6B||3.0|-3.1|
72381944|NCT01298544|144272619|SUPERIORITY_OR_OTHER||Difference in proportions|0.7|||||TWO_SIDED|95.0|-5.9|7.3|||||Difference in proportions, expressed as a percentage. Exact 2 sided CI for the difference in proportions (Group 2-Group 1), expressed as a percentage.|Serotype 9V||7.3|-5.9|
72381945|NCT01298544|144272619|SUPERIORITY_OR_OTHER||Difference in proportions|-3.4|||||TWO_SIDED|95.0|-10.3|3.1|||||Difference in proportions, expressed as a percentage. Exact 2 sided CI for the difference in proportions (Group 2-Group 1), expressed as a percentage.|Serotype 14||3.1|-10.3|
72381946|NCT01298544|144272619|SUPERIORITY_OR_OTHER||Difference in proportions|-11.9|||||TWO_SIDED|95.0|-22.7|-1.0|||||Difference in proportions, expressed as a percentage. Exact 2 sided CI for the difference in proportions (Group 2-Group 1), expressed as a percentage.|Serotype 18C||-1.0|-22.7|
72381947|NCT01298544|144272619|SUPERIORITY_OR_OTHER||Difference in proportions|-2.5|||||TWO_SIDED|95.0|-7.1|0.6|||||Difference in proportions, expressed as a percentage. Exact 2 sided CI for the difference in proportions (Group 2-Group 1), expressed as a percentage.|Serotype 19F||0.6|-7.1|
72381948|NCT01298544|144272619|SUPERIORITY_OR_OTHER||Difference in proportions|-0.8|||||TWO_SIDED|95.0|-4.5|2.3|||||Difference in proportions, expressed as a percentage. Exact 2 sided CI for the difference in proportions (Group 2-Group 1), expressed as a percentage.|Serotype 23F||2.3|-4.5|
72381949|NCT01298544|144272619|SUPERIORITY_OR_OTHER||Difference in proportions|25.0|||||TWO_SIDED|95.0|12.7|37.0|||||Difference in proportions, expressed as a percentage. Exact 2 sided CI for the difference in proportions (Group 1 and 2 combined-Group 3), expressed as a percentage.|Serotype 4||37.0|12.7|
72381950|NCT01298544|144272619|SUPERIORITY_OR_OTHER||Difference in proportions|2.2|||||TWO_SIDED|95.0|-0.011|7.715|||||Difference in proportions, expressed as a percentage. Exact 2 sided CI for the difference in proportions (Group 1 and 2 combined-Group 3), expressed as a percentage.|Serotype 6B||7.715|-0.011|
72381951|NCT01298544|144272619|SUPERIORITY_OR_OTHER||Difference in proportions|10.3|||||TWO_SIDED|95.0|1.9|19.6|||||Difference in proportions, expressed as a percentage. Exact 2 sided CI for the difference in proportions (Group 1 and 2 combined-Group 3), expressed as a percentage.|Serotype 9V||19.6|1.9|
72381952|NCT01298544|144272619|SUPERIORITY_OR_OTHER||Difference in proportions|29.7|||||TWO_SIDED|95.0|19.4|40.5|||||Difference in proportions, expressed as a percentage. Exact 2 sided CI for the difference in proportions (Group 1 and 2 combined-Group 3), expressed as a percentage.|Serotype 14||40.5|19.4|
72381953|NCT01298544|144272619|SUPERIORITY_OR_OTHER||Difference in proportions|30.0|||||TWO_SIDED|95.0|17.9|41.5|||||Difference in proportions, expressed as a percentage. Exact 2 sided CI for the difference in proportions (Group 1 and 2 combined-Group 3), expressed as a percentage.|Serotype 18C||41.5|17.9|
72381954|NCT01298544|144272619|SUPERIORITY_OR_OTHER||Difference in proportions|6.5|||||TWO_SIDED|95.0|1.2|13.9|||||Difference in proportions, expressed as a percentage. Exact 2 sided CI for the difference in proportions (Group 1 and 2 combined-Group 3), expressed as a percentage.|Serotype 19F||13.9|1.2|
72381955|NCT01298544|144272619|SUPERIORITY_OR_OTHER||Difference in proportions|6.2|||||TWO_SIDED|95.0|1.8|13.0|||||Difference in proportions, expressed as a percentage. Exact 2 sided CI for the difference in proportions (Group 1 and 2 combined-Group 3), expressed as a percentage.|Serotype 23F||13.0|1.8|
72381956|NCT02718300|144272626|SUPERIORITY|||||||0.4046|||||||Van Elteren test|stratified by ECOG Performance Status at Screening (0 or 1 versus 2)||||||0.4046
72381957|NCT02718300|144272628|SUPERIORITY|||||||0.7802|||||||Van Elteren test|stratified by ECOG Performance Status at Screening (0 or 1 versus 2)||||||0.7802
72381958|NCT02718300|144272630|SUPERIORITY|||||||0.6856|||||||Van Elteren test|stratified by ECOG Performance Status at Screening (0 or 1 versus 2)||||||0.6856
72381959|NCT02718300|144272632|SUPERIORITY|||||||0.3385|||||||Van Elteren test|stratified by ECOG Performance Status at Screening (0 or 1 versus 2)||||||0.3385
72381960|NCT02718300|144272634|SUPERIORITY|||||||0.4005|||||||Van Elteren test|stratified by Easter Cooperative Oncology Group (ECOG) Performance Status at Screening (0 or 1 versus 2)||||||0.4005
72381961|NCT02718300|144272636|SUPERIORITY|||||||0.3138|||||||Van Elteren test|stratified by ECOG Performance Status at Screening (0 or 1 versus 2)||||||0.3138
72381962|NCT02718300|144272642|SUPERIORITY|||||||0.3577|||||||ANOVA|||Week 2||||0.3577
72381963|NCT02718300|144272642|SUPERIORITY||Geometric Mean Ratio (GMR)|1.048|||||TWO_SIDED|95.0|0.791|1.388|||||ANOVA was performed on dose-normalized PK parameters per dose level. The reference group was 5 mg QD.|Week 2||1.388|0.791|
72381964|NCT02718300|144272642|SUPERIORITY||GMR|1.159|||||TWO_SIDED|95.0|0.936|1.435|||||ANOVA was performed on dose-normalized PK parameters per dose level. The reference group was 5 mg QD.|Week 2||1.435|0.936|
72381965|NCT02718300|144272642|SUPERIORITY|||||||0.1709|||||||ANOVA|||Week 4||||0.1709
72381966|NCT02718300|144272642|SUPERIORITY||GMR|1.0|||||TWO_SIDED|95.0|0.78|1.281|||||ANOVA was performed on dose-normalized PK parameters per dose level. The reference group was 5 mg QD.|Week 4||1.281|0.780|
72381967|NCT02718300|144272642|SUPERIORITY||GMR|1.176|||||TWO_SIDED|95.0|0.955|1.448|||||ANOVA was performed on dose-normalized PK parameters per dose level. The reference group was 5 mg QD.|Week 4||1.448|0.955|
72381968|NCT02718300|144272643|SUPERIORITY|||||||0.6693|||||||Kruskal-Wallis|||Week 2||||0.6693
72381969|NCT02718300|144272643|SUPERIORITY|||||||0.1521|||||||Kruskal-Wallis|||Week 4||||0.1521
72381970|NCT02718300|144272644|SUPERIORITY|||||||0.0809|||||||ANOVA|||Week 2||||0.0809
72381971|NCT02718300|144272644|SUPERIORITY||GMR|0.583|||||TWO_SIDED|95.0|0.342|0.994|||||ANOVA was performed on dose-normalized PK parameters per dose level. The reference group was 5 mg QD.|Week 2||0.994|0.342|
72434319|NCT04771273|144381926|OTHER|No confirmatory hypothesis testing was performed.|Mean Difference (Net)|-10.91|||<|0.0001|TWO_SIDED|95.0|-12.96|-8.86||The p-value reported is considered nominal.|MMRM||"Survodutide 4.8 mg - Placebo."|Least Squares Mean differences and 95% confidence interval were calculated from mixed-effect model for repeated measures (MMRM) including fixed effects for baseline liver fat content (%) as a continuous linear covariate, and treatment, presence of diabetes of any type \[yes, no\], baseline fibrosis score \[F1, F2, F3\], visit, treatment by visit interaction and baseline by visit interaction as factors.||-8.86|-12.96|<.0001
72434320|NCT04771273|144381926|OTHER|No confirmatory hypothesis testing was performed.|Mean Difference (Net)|-11.07|||<|0.0001|TWO_SIDED|95.0|-13.23|-8.92||The p-value reported is considered nominal.|MMRM||"Survodutide 6.0 mg - Placebo."|Least Squares Mean differences and 95% confidence interval were calculated from mixed-effect model for repeated measures (MMRM) including fixed effects for baseline liver fat content (%) as a continuous linear covariate, and treatment, presence of diabetes of any type \[yes, no\], baseline fibrosis score \[F1, F2, F3\], visit, treatment by visit interaction and baseline by visit interaction as factors.||-8.92|-13.23|<.0001
72434321|NCT04771273|144381927|OTHER|No confirmatory hypothesis testing was performed.|Mean Difference (Net)|-9.12|||<|0.0001|TWO_SIDED|95.0|-11.21|-7.03||The p-value reported is considered nominal.|MMRM||"Survodutide 2.4 mg - Placebo."|Least Squares Mean differences and 95% confidence interval were calculated from mixed-effect model for repeated measures (MMRM) including fixed effects for baseline liver fat content (%) as a continuous linear covariate, and treatment, presence of diabetes of any type \[yes, no\], baseline fibrosis score \[F1, F2, F3\], visit, treatment by visit interaction and baseline by visit interaction as factors.||-7.03|-11.21|<.0001
72434322|NCT04771273|144381927|OTHER|No confirmatory hypothesis testing was performed.|Mean Difference (Net)|-10.79|||<|0.0001|TWO_SIDED|95.0|-12.85|-8.73||The p-value reported is considered nominal.|MMRM||"Survodutide 4.8 mg - Placebo."|Least Squares Mean differences and 95% confidence interval were calculated from mixed-effect model for repeated measures (MMRM) including fixed effects for baseline liver fat content (%) as a continuous linear covariate, and treatment, presence of diabetes of any type \[yes, no\], baseline fibrosis score \[F1, F2, F3\], visit, treatment by visit interaction and baseline by visit interaction as factors.||-8.73|-12.85|<.0001
72434323|NCT04771273|144381927|OTHER|No confirmatory hypothesis testing was performed.|Mean Difference (Net)|-10.86|||<|0.0001|TWO_SIDED|95.0|-13.0|-8.73||The p-value reported is considered nominal.|MMRM||"Survodutide 6.0 mg - Placebo."|Least Squares Mean differences and 95% confidence interval were calculated from mixed-effect model for repeated measures (MMRM) including fixed effects for baseline liver fat content (%) as a continuous linear covariate, and treatment, presence of diabetes of any type \[yes, no\], baseline fibrosis score \[F1, F2, F3\], visit, treatment by visit interaction and baseline by visit interaction as factors.||-8.73|-13.00|<.0001
72434324|NCT04771273|144381928|OTHER|No confirmatory hypothesis testing was performed.|Mean Difference (Net)|-43.64|||<|0.0001|TWO_SIDED|95.0|-53.49|-33.79||The p-value reported is considered nominal.|MMRM||"Survodutide 2.4 mg - Placebo"|Least Squares Mean differences and 95% confidence interval were calculated from mixed-effect model for repeated measures (MMRM) including fixed effects for baseline liver fat content (%) as a continuous linear covariate, and treatment, presence of diabetes of any type \[yes, no\], baseline fibrosis score \[F1, F2, F3\], visit, treatment by visit interaction and baseline by visit interaction as factors.||-33.79|-53.49|<.0001
72434325|NCT04771273|144381928|OTHER|No confirmatory hypothesis testing was performed.|Mean Difference (Net)|-55.52|||<|0.0001|TWO_SIDED|95.0|-65.61|-45.42||The p-value reported is considered nominal.|MMRM||"Survodutide 4.8 mg - Placebo"|Least Squares Mean differences and 95% confidence interval were calculated from mixed-effect model for repeated measures (MMRM) including fixed effects for baseline liver fat content (%) as a continuous linear covariate, and treatment, presence of diabetes of any type \[yes, no\], baseline fibrosis score \[F1, F2, F3\], visit, treatment by visit interaction and baseline by visit interaction as factors.||-45.42|-65.61|<.0001
72434326|NCT04771273|144381928|OTHER|No confirmatory hypothesis testing was performed.|Mean Difference (Net)|-57.02|||<|0.0001|TWO_SIDED|95.0|-67.66|-46.39||The p-value reported is considered nominal.|MMRM||"Survodutide 6.0 mg-Placebo"|Least Squares Mean differences and 95% confidence interval were calculated from mixed-effect model for repeated measures (MMRM) including fixed effects for baseline liver fat content (%) as a continuous linear covariate, and treatment, presence of diabetes of any type \[yes, no\], baseline fibrosis score \[F1, F2, F3\], visit, treatment by visit interaction and baseline by visit interaction as factors.||-46.39|-67.66|<.0001
72434327|NCT04771273|144381929|OTHER|No confirmatory hypothesis testing was performed.|Mean Difference (Net)|-46.49|||<|0.0001|TWO_SIDED|95.0|-56.74|-36.25||The p-value reported is considered nominal.|MMRM||"Survodutide 2.4 mg - Placebo"|Least Squares Mean differences and 95% confidence interval were calculated from mixed-effect model for repeated measures (MMRM) including fixed effects for baseline liver fat content (%) as a continuous linear covariate, and treatment, presence of diabetes of any type \[yes, no\], baseline fibrosis score \[F1, F2, F3\], visit, treatment by visit interaction and baseline by visit interaction as factors.||-36.25|-56.74|<.0001
72434328|NCT04771273|144381929|OTHER|No confirmatory hypothesis testing was performed.|Mean Difference (Net)|-55.11|||<|0.0001|TWO_SIDED|95.0|-65.25|-44.98||The p-value reported is considered nominal.|MMRM||"Survodutide 4.8 mg - Placebo"|Least Squares Mean differences and 95% confidence interval were calculated from mixed-effect model for repeated measures (MMRM) including fixed effects for baseline liver fat content (%) as a continuous linear covariate, and treatment, presence of diabetes of any type \[yes, no\], baseline fibrosis score \[F1, F2, F3\], visit, treatment by visit interaction and baseline by visit interaction as factors.||-44.98|-65.25|<.0001
72434329|NCT04771273|144381929|OTHER|No confirmatory hypothesis testing was performed.|Mean Difference (Net)|-56.26|||<|0.0001|TWO_SIDED|95.0|-66.76|-45.77||The p-value reported is considered nominal.|MMRM||"Survodutide 6.0 mg-Placebo"|Least Squares Mean differences and 95% confidence interval were calculated from mixed-effect model for repeated measures (MMRM) including fixed effects for baseline liver fat content (%) as a continuous linear covariate, and treatment, presence of diabetes of any type \[yes, no\], baseline fibrosis score \[F1, F2, F3\], visit, treatment by visit interaction and baseline by visit interaction as factors.||-45.77|-66.76|<.0001
72434330|NCT04771273|144381930|OTHER|No confirmatory hypothesis testing was performed.|Odds Ratio (OR)|1.61||||0.1894|TWO_SIDED|95.0|0.79|3.26||The p-value reported is considered nominal.|Regression, Logistic||Survodutide 2.4 mg vs. Placebo|The logistic regression model included actual treatment, presence of diabetes of any type and baseline fibrosis score. Firth's penalized regression was used.||3.26|0.79|0.1894
72556988|NCT03214588|144645329|SUPERIORITY||Least Squares Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|0.123||0.946|TWO_SIDED|90.0|0.0|0.41||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA||MMRM ANCOVA with Baseline FARS ADL as a covariate; pooled site, visit, treatment, and ambulation status (randomization factor) as fixed factors; and treatment-by-visit and Baseline FARS ADL-by-visit interactions.|Change at Week 2, Personal Hygiene||0.41|0.00|0.946
72556989|NCT03214588|144645329|SUPERIORITY||Least Squares Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.193||0.505|TWO_SIDED|90.0|-0.32|0.33||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA||MMRM ANCOVA with Baseline FARS ADL as a covariate; pooled site, visit, treatment, and ambulation status (randomization factor) as fixed factors; and treatment-by-visit and Baseline FARS ADL-by-visit interactions.|Change at Week 7, Personal Hygiene||0.33|-0.32|0.505
72556990|NCT03214588|144645329|SUPERIORITY||Least Squares Mean Difference|0.06|STANDARD_ERROR_OF_MEAN|0.158||0.658|TWO_SIDED|90.0|-0.2|0.33||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA||MMRM ANCOVA with Baseline FARS ADL as a covariate; pooled site, visit, treatment, and ambulation status (randomization factor) as fixed factors; and treatment-by-visit and Baseline FARS ADL-by-visit interactions.|Change at Week 7, Personal Hygiene||0.33|-0.20|0.658
72556991|NCT03214588|144645329|SUPERIORITY||Least Squares Mean Difference|0.07|STANDARD_ERROR_OF_MEAN|0.184||0.649|TWO_SIDED|90.0|-0.24|0.38||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA||MMRM ANCOVA with Baseline FARS ADL as a covariate; pooled site, visit, treatment, and ambulation status (randomization factor) as fixed factors; and treatment-by-visit and Baseline FARS ADL-by-visit interactions.|Change at Week 12, Personal Hygiene||0.38|-0.24|0.649
72556992|NCT03214588|144645329|SUPERIORITY||Least Squares Mean Difference|0.06|STANDARD_ERROR_OF_MEAN|0.151||0.661|TWO_SIDED|90.0|-0.19|0.32||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA||MMRM ANCOVA with Baseline FARS ADL as a covariate; pooled site, visit, treatment, and ambulation status (randomization factor) as fixed factors; and treatment-by-visit and Baseline FARS ADL-by-visit interactions.|Change at Week 12, Personal Hygiene||0.32|-0.19|0.661
72556993|NCT03214588|144645330|SUPERIORITY||Least Squares Mean Difference|2.67|STANDARD_ERROR_OF_MEAN|1.078||0.992|TWO_SIDED|90.0|0.86|4.47||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA|||Change from Baseline at Week 2||4.47|0.86|0.992
72556994|NCT03214588|144645330|SUPERIORITY||Least Squares Mean Difference|2.78|STANDARD_ERROR_OF_MEAN|0.892||0.999|TWO_SIDED|90.0|1.29|4.28||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA|||Change from Baseline at Week 2||4.28|1.29|0.999
72556995|NCT03214588|144645330|SUPERIORITY||Least Squares Mean Difference|0.4|STANDARD_ERROR_OF_MEAN|1.338||0.616|TWO_SIDED|90.0|-1.84|2.64||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA|||Change from Baseline at Week 7||2.64|-1.84|0.616
72556996|NCT03214588|144645330|SUPERIORITY||Least Squares Mean Difference|1.06|STANDARD_ERROR_OF_MEAN|1.131||0.823|TWO_SIDED|90.0|-0.83|2.95||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA|||Change from Baseline at Week 7||2.95|-0.83|0.823
72556997|NCT03214588|144645330|SUPERIORITY||Least Squares Mean Difference|2.02|STANDARD_ERROR_OF_MEAN|1.266||0.942|TWO_SIDED|90.0|-0.1|4.13||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA|||Change from Baseline at Week 12||4.13|-0.10|0.942
72556998|NCT03214588|144645330|SUPERIORITY||Least Squares Mean Difference|2.11|STANDARD_ERROR_OF_MEAN|1.053||0.975|TWO_SIDED|90.0|0.35|3.87||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA|||Change from Baseline at Week 12||3.87|0.35|0.975
72556999|NCT03214588|144645331|SUPERIORITY||Least Squares Mean Difference|0.07|STANDARD_ERROR_OF_MEAN|0.133|||TWO_SIDED|90.0|-0.15|0.29||||||Change at Week 2, Bulbar||0.29|-0.15|
72557000|NCT03214588|144645331|SUPERIORITY||Least Squares Mean Difference|0.06|STANDARD_ERROR_OF_MEAN|0.11|||TWO_SIDED|90.0|-0.12|0.25||||||Change at Week 2, Bulbar||0.25|-0.12|
72557001|NCT03214588|144645331|SUPERIORITY||Least Squares Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.122|||TWO_SIDED|90.0|-0.3|0.11||||||Change at Week 7, Bulbar||0.11|-0.30|
72557002|NCT03214588|144645331|SUPERIORITY||Least Squares Mean Difference|0.16|STANDARD_ERROR_OF_MEAN|0.104|||TWO_SIDED|90.0|-0.02|0.33||||||Change at Week 7, Bulbar||0.33|-0.02|
72557003|NCT03214588|144645331|SUPERIORITY||Least Squares Mean Difference|0.05|STANDARD_ERROR_OF_MEAN|0.141|||TWO_SIDED|90.0|-0.19|0.28||||||Change at Week 12, Bulbar||0.28|-0.19|
72557004|NCT03214588|144645331|SUPERIORITY||Least Squares Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|0.118|||TWO_SIDED|90.0|0.0|0.4||||||Change at Week 12, Bulbar||0.40|0.00|
72557005|NCT03214588|144645331|SUPERIORITY||Least Squares Mean Difference|1.99|STANDARD_ERROR_OF_MEAN|0.689|||TWO_SIDED|90.0|0.83|3.14||||||Change at Week 2, Upper Limb Coordination||3.14|0.83|
72557006|NCT03214588|144645331|SUPERIORITY||Least Squares Mean Difference|1.02|STANDARD_ERROR_OF_MEAN|0.571|||TWO_SIDED|90.0|0.06|1.97||||||Change at Week 2, Upper Limb Coordination||1.97|0.06|
72557007|NCT03214588|144645331|SUPERIORITY||Least Squares Mean Difference|1.08|STANDARD_ERROR_OF_MEAN|0.882|||TWO_SIDED|90.0|-0.4|2.55||||||Change at Week 7, Upper Limb Coordination||2.55|-0.40|
72557008|NCT03214588|144645331|SUPERIORITY||Least Squares Mean Difference|0.18|STANDARD_ERROR_OF_MEAN|0.743|||TWO_SIDED|90.0|-1.06|1.43||||||Change at Week 7, Upper Limb Coordination||1.43|-1.06|
72557009|NCT03214588|144645331|SUPERIORITY||Least Squares Mean Difference|1.21|STANDARD_ERROR_OF_MEAN|1.016|||TWO_SIDED|90.0|-0.48|2.91||||||Change at Week 12, Upper Limb Coordination||2.91|-0.48|
72557010|NCT03214588|144645331|SUPERIORITY||Least Squares Mean Difference|0.53|STANDARD_ERROR_OF_MEAN|0.84|||TWO_SIDED|90.0|-0.87|1.94||||||Change at Week 12, Upper Limb Coordination||1.94|-0.87|
72557011|NCT03214588|144645331|SUPERIORITY||Least Squares Mean Difference|0.4|STANDARD_ERROR_OF_MEAN|0.482|||TWO_SIDED|90.0|-0.41|1.2||||||Change at Week 2, Lower Limb Coordination||1.20|-0.41|
72557012|NCT03214588|144645331|SUPERIORITY||Least Squares Mean Difference|0.79|STANDARD_ERROR_OF_MEAN|0.397|||TWO_SIDED|90.0|0.12|1.45||||||Change at Week 2, Lower Limb Coordination||1.45|0.12|
72493980|NCT02682901|144516977|SUPERIORITY|||||||0.068||||||Between treatment group (bromocriptine-QR vs. placebo) differences in change from baseline to week 24 was analyzed using Independent Samples T-tests. Means are statistically significantly different at the 5% level (P \< 0.05) two-sided.|t-test, 2 sided|||||||0.068
72434331|NCT04771273|144381930|OTHER|No confirmatory hypothesis testing was performed.|Odds Ratio (OR)|2.0||||0.0685|TWO_SIDED|95.0|0.95|4.2||The p-value reported is considered nominal.|Regression, Logistic||Survodutide 4.8 mg vs. Placebo|The logistic regression model included actual treatment, presence of diabetes of any type and baseline fibrosis score. Firth's penalized regression was used.||4.20|0.95|0.0685
72434332|NCT04771273|144381930|OTHER|No confirmatory hypothesis testing was performed.|Odds Ratio (OR)|3.37||||0.0028|TWO_SIDED|95.0|1.52|7.45||The p-value reported is considered nominal.|Regression, Logistic||Survodutide 6.0 mg vs. Placebo|The logistic regression model included actual treatment, presence of diabetes of any type and baseline fibrosis score. Firth's penalized regression was used.||7.45|1.52|0.0028
72434333|NCT04771273|144381931|OTHER|No confirmatory hypothesis testing was performed.|Odds Ratio (OR)|2.02||||0.0663|TWO_SIDED|95.0|0.95|4.27||The p-value reported is considered nominal.|Regression, Logistic||Survodutide 2.4 mg vs. Placebo|The logistic regression model included planned treatment, presence of diabetes of any type and baseline fibrosis score. Firth's penalized regression was used.||4.27|0.95|0.0663
72434334|NCT04771273|144381931|OTHER|No confirmatory hypothesis testing was performed.|Odds Ratio (OR)|2.01||||0.0672|TWO_SIDED|95.0|0.95|4.23||The p-value reported is considered nominal.|Regression, Logistic||Survodutide 4.8 mg vs. Placebo|The logistic regression model included planned treatment, presence of diabetes of any type and baseline fibrosis score. Firth's penalized regression was used.||4.23|0.95|0.0672
72434335|NCT04771273|144381931|OTHER|No confirmatory hypothesis testing was performed.|Odds Ratio (OR)|2.11||||0.0512|TWO_SIDED|95.0|1.0|4.46||The p-value reported is considered nominal.|Regression, Logistic||Survodutide 6.0 mg vs. Placebo|The logistic regression model included planned treatment, presence of diabetes of any type and baseline fibrosis score. Firth's penalized regression was used.||4.46|1.00|0.0512
72434336|NCT00708097|144381963|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|1.98||||0.5757|TWO_SIDED|95.0|-5.0|8.97||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment and period with subject as a random effect.|Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|Null hypothesis considered population means of the treatments in comparison, to be equal with respect to percent SMH. Statistical tests were 2-sided with a significance level of 0.05.||8.97|-5.00|0.5757
72434337|NCT00708097|144381964|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|2.17||||0.5387|TWO_SIDED|95.0|-4.79|9.14||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment and period with subject as a random effect.|Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|Null hypothesis considered population means of the treatments in comparison, to be equal with respect to percent SMH. Statistical tests were 2-sided with a significance level of 0.05.||9.14|-4.79|0.5387
72434338|NCT00708097|144381964|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|2.79||||0.4306|TWO_SIDED|95.0|-4.18|9.77||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment and period with subject as a random effect.|Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|Null hypothesis considered population means of the treatments in comparison, to be equal with respect to percent SMH. Statistical tests were 2-sided with a significance level of 0.05.||9.77|-4.18|0.4306
72434339|NCT00708097|144381964|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-25.07|||<|0.0001|TWO_SIDED|95.0|-32.09|-18.06||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment and period with subject as a random effect.|Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|Null hypothesis considered population means of the treatments in comparison, to be equal with respect to percent SMH. Statistical tests were 2-sided with a significance level of 0.05.||-18.06|-32.09|<0.0001
72434340|NCT00708097|144381964|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.19||||0.9567|TWO_SIDED|95.0|-6.71|7.09||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment and period with subject as a random effect.|Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|Null hypothesis considered population means of the treatments in comparison, to be equal with respect to percent SMH. Statistical tests were 2-sided with a significance level of 0.05.||7.09|-6.71|0.9567
72493981|NCT02682901|144516978|SUPERIORITY|||||||0.493||||||Between treatment group (bromocriptine-QR vs. placebo) differences in change from baseline to week 24 was analyzed using Independent Samples T-tests. Means are statistically significantly different at the 5% level (P \< 0.05) two-sided.|t-test, 2 sided|||||||0.493
72557013|NCT03214588|144645331|SUPERIORITY||Least Squares Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.837|||TWO_SIDED|90.0|-1.44|1.36||||||Change at Week 7, Lower Limb Coordination||1.36|-1.44|
72434341|NCT00708097|144381964|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.81||||0.8188|TWO_SIDED|95.0|-6.14|7.76||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment and period with subject as a random effect.|Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|Null hypothesis considered population means of the treatments in comparison, to be equal with respect to percent SMH. Statistical tests were 2-sided with a significance level of 0.05.||7.76|-6.14|0.8188
72434342|NCT00708097|144381964|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-27.06|||<|0.0001|TWO_SIDED|95.0|-34.03|-20.08||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment and period with subject as a random effect.|Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|Null hypothesis considered population means of the treatments in comparison, to be equal with respect to percent SMH. Statistical tests were 2-sided with a significance level of 0.05.||-20.08|-34.03|<0.0001
72557014|NCT03214588|144645331|SUPERIORITY||Least Squares Mean Difference|0.17|STANDARD_ERROR_OF_MEAN|0.707|||TWO_SIDED|90.0|-1.01|1.36||||||Change at Week 7, Lower Limb Coordination||1.36|-1.01|
72434343|NCT00708097|144381964|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.62||||0.8599|TWO_SIDED|95.0|-6.28|7.51||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment and period with subject as a random effect.|Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|Null hypothesis considered population means of the treatments in comparison, to be equal with respect to percent SMH. Statistical tests were 2-sided with a significance level of 0.05.||7.51|-6.28|0.8599
72434344|NCT00708097|144381964|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-27.25|||<|0.0001|TWO_SIDED|95.0|-34.2|-20.3||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment and period with subject as a random effect.|Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|Null hypothesis considered population means of the treatments in comparison, to be equal with respect to percent SMH. Statistical tests were 2-sided with a significance level of 0.05.||-20.30|-34.20|<0.0001
72557015|NCT03214588|144645331|SUPERIORITY||Least Squares Mean Difference|0.99|STANDARD_ERROR_OF_MEAN|0.755|||TWO_SIDED|90.0|-0.27|2.25||||||Change at Week 12, Lower Limb Coordination||2.25|-0.27|
72557016|NCT03214588|144645331|SUPERIORITY||Least Squares Mean Difference|0.95|STANDARD_ERROR_OF_MEAN|0.626|||TWO_SIDED|90.0|-0.09|2.0||||||Change at Week 12, Lower Limb Coordination||2.00|-0.09|
72557017|NCT03214588|144645331|SUPERIORITY||Least Squares Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|0.63|||TWO_SIDED|90.0|-0.8|1.3||||||Change at Week 2, Upright Stability||1.3|-0.8|
72434345|NCT00708097|144381964|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-27.87|||<|0.0001|TWO_SIDED|95.0|-34.84|-20.89||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment and period with subject as a random effect.|Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|Null hypothesis considered population means of the treatments in comparison, to be equal with respect to percent SMH. Statistical tests were 2-sided with a significance level of 0.05.||-20.89|-34.84|<0.0001
72434346|NCT00708097|144381965|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.45||||0.5451|TWO_SIDED|95.0|-6.15|3.26||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment and period with subject as a random effect.|Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|Null hypothesis considered population means of the treatments in comparison, to be equal with respect to percent SMH. Statistical tests were 2-sided with a significance level of 0.05.||3.26|-6.15|0.5451
72434347|NCT00708097|144381965|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|3.5||||0.1433|TWO_SIDED|95.0|-1.2|8.19||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment and period with subject as a random effect.|Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|Null hypothesis considered population means of the treatments in comparison, to be equal with respect to percent SMH. Statistical tests were 2-sided with a significance level of 0.05.||8.19|-1.20|0.1433
72434348|NCT00708097|144381965|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|7.47||||0.002|TWO_SIDED|95.0|2.78|12.16||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment and period with subject as a random effect.|Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|Null hypothesis considered population means of the treatments in comparison, to be equal with respect to percent SMH. Statistical tests were 2-sided with a significance level of 0.05.||12.16|2.78|0.0020
72434349|NCT00708097|144381965|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|23.52|||<|0.0001|TWO_SIDED|95.0|18.79|28.25||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment and period with subject as a random effect.|Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|Null hypothesis considered population means of the treatments in comparison, to be equal with respect to percent SMH. Statistical tests were 2-sided with a significance level of 0.05.||28.25|18.79|<0.0001
72434350|NCT00708097|144381965|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|4.94||||0.0373|TWO_SIDED|95.0|0.29|9.59||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment and period with subject as a random effect.|Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|Null hypothesis considered population means of the treatments in comparison, to be equal with respect to percent SMH. Statistical tests were 2-sided with a significance level of 0.05.||9.59|0.29|0.0373
72557018|NCT03214588|144645331|SUPERIORITY||Least Squares Mean Difference|1.0|STANDARD_ERROR_OF_MEAN|0.52|||TWO_SIDED|90.0|0.1|1.9||||||Change at Week 2, Upright Stability||1.9|0.1|
72557019|NCT03214588|144645331|SUPERIORITY||Least Squares Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.45|||TWO_SIDED|90.0|-1.3|0.2||||||Change at Week 7, Upright Stability||0.2|-1.3|
72557020|NCT03214588|144645331|SUPERIORITY||Least Squares Mean Difference|0.6|STANDARD_ERROR_OF_MEAN|0.38|||TWO_SIDED|90.0|0.0|1.2||||||Change at Week 7, Upright Stability||1.2|0.0|
72557021|NCT03214588|144645331|SUPERIORITY||Least Squares Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.57|||TWO_SIDED|90.0|-1.2|0.7||||||Change at Week 12, Upright Stability||0.7|-1.2|
72557022|NCT03214588|144645331|SUPERIORITY||Least Squares Mean Difference|0.5|STANDARD_ERROR_OF_MEAN|0.48|||TWO_SIDED|90.0|-0.3|1.3||||||Change at Week 12, Upright Stability||1.3|-0.3|
72434351|NCT00708097|144381965|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|8.92||||0.0002|TWO_SIDED|95.0|4.24|13.59||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment and period with subject as a random effect.|Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|Null hypothesis considered population means of the treatments in comparison, to be equal with respect to percent SMH. Statistical tests were 2-sided with a significance level of 0.05.||13.59|4.24|0.0002
72557023|NCT03214588|144645332|SUPERIORITY||Least Squares Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.084|||TWO_SIDED|90.0|-0.13|0.15||||||Change at Week 2, Cough||0.15|-0.13|
72557024|NCT03214588|144645332|SUPERIORITY||Least Squares Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.069|||TWO_SIDED|90.0|-0.11|0.12||||||Change at Week 2, Cough||0.12|-0.11|
72381972|NCT02718300|144272644|SUPERIORITY||GMR|0.986|||||TWO_SIDED|95.0|0.658|1.477|||||ANOVA was performed on dose-normalized PK parameters per dose level. The reference group was 5 mg QD.|Week 2||1.477|0.658|
72381973|NCT02718300|144272644|SUPERIORITY|||||||0.1525|||||||ANOVA|||Week 4||||0.1525
72493982|NCT02682901|144516979|SUPERIORITY|||||||0.524||||||Between treatment group (bromocriptine-QR vs. placebo) differences in change from baseline to week 24 was analyzed using Independent Samples T-tests. Means were statistically significantly different at the 5% level (P \< 0.05) two-sided.|t-test, 2 sided|||||||0.524
72493983|NCT02682901|144516980|SUPERIORITY|||||||0.63||||||Between treatment group (bromocriptine-QR vs. placebo) differences in change from baseline to week 24 was analyzed using Independent Samples T-tests. Means were statistically significantly different at the 5% level (P \< 0.05) two-sided.|t-test, 2 sided|||||||0.630
72493984|NCT02682901|144516981|SUPERIORITY|||||||0.537||||||Between treatment group (bromocriptine-QR vs. placebo) differences in change from baseline to week 24 was analyzed using Independent Samples T-tests. Means were statistically significantly different at the 5% level (P \< 0.05) two-sided.|t-test, 2 sided|||||||0.537
72493985|NCT02682901|144516982|SUPERIORITY|||||||0.53||||||Between treatment group (bromocriptine-QR vs. placebo) differences in change from baseline to week 24 was analyzed using Independent Samples T-tests. Means were statistically significantly different at the 5% level (P \< 0.05) two-sided.|t-test, 2 sided|||||||0.530
72493986|NCT02682901|144516983|SUPERIORITY|||||||0.005||||||Between treatment group (bromocriptine-QR vs. placebo) differences in change from baseline to week 24 was analyzed using Independent Samples T-tests. Means were statistically significantly different at the 5% level (P \< 0.05) two-sided.|t-test, 2 sided|||||||0.005
72493987|NCT02573155|144517025|SUPERIORITY_OR_OTHER||Least Square Mean|0.111|STANDARD_ERROR_OF_MEAN|0.0265|<|0.0001|TWO_SIDED|95.0|0.0585|0.163|||ANCOVA|||||0.163|0.0585|<0.0001
72493988|NCT02573155|144517025|SUPERIORITY_OR_OTHER||Least square mean|0.21|STANDARD_ERROR_OF_MEAN|0.0272|<|0.0001||95.0|0.156|0.264|||ANCOVA|||||0.264|0.156|<0.0001
72493989|NCT02301403|144517039|SUPERIORITY||Odds Ratio (OR)|2.95|||<|0.001|TWO_SIDED|95.0|1.69|5.14|||Regression, Logistic|||||5.14|1.69|<.001
72493990|NCT03434977|144517040|OTHER||Ratio|0.937|||||TWO_SIDED|90.0|0.89|0.986||||||The shown data were ratio of fed conditions divided by fasted conditions, taking anti-logs of the least square (LS) means difference (fed-fasted) or confidence interval (CI). The difference in LS means between treatment conditions (fed-fasted) and two-sided 90% CI were provided using a crossover analysis of variance (ANOVA) model. ANOVA model included log-transformed (natural log) PK parameters Cmax as dependent variable, and treatment condition, group, and period as independent variables.||0.986|0.890|
72493991|NCT03434977|144517041|OTHER||LS-Means Difference|0.9083|||||TWO_SIDED|90.0|0.1821|1.6345||||||The difference in the LS means between treatment conditions (fed-fasted) and the two-sided 90% CI were provided using a crossover ANOVA model. The ANOVA model included log-transformed (non-natural log) PK parameters tmax as dependent variable, and treatment condition, group, and period as independent variables.||1.6345|0.1821|
72493992|NCT03434977|144517042|OTHER||Ratio|0.998|||||TWO_SIDED|90.0|0.943|1.056||||||The shown data were the ratio of the fed conditions divided by the fasted conditions, taking anti-logs of the LS means difference (fed-fasted) or CI. The difference in the LS means between treatment conditions (fed-fasted) and the two-sided 90% CI were provided using a crossover ANOVA model. The ANOVA model included log-transformed (natural log) PK parameters AUClast as dependent variable, and treatment condition, group, and period as independent variables.||1.056|0.943|
72493993|NCT03434977|144517043|OTHER||Ratio|0.997|||||TWO_SIDED|90.0|0.942|1.056||||||The shown data were the ratio of the fed conditions divided by the fasted conditions, taking anti-logs of the LS means difference (fed-fasted) or CI. The difference in the LS means between treatment conditions (fed-fasted) and the two-sided 90% CI were provided using a crossover ANOVA model. The ANOVA model included log-transformed (natural log) PK parameters AUC∞ as dependent variable, and treatment condition, group, and period as independent variables.||1.056|0.942|
72493994|NCT03434977|144517044|OTHER||Ratio|0.985|||||TWO_SIDED|90.0|0.932|1.041||||||The shown data were the ratio of the fed conditions divided by the fasted conditions, taking anti-logs of the LS means difference (fed-fasted) or CI. The difference in the LS means between treatment conditions (fed-fasted) and the two-sided 90% CI were provided using a crossover ANOVA model. The ANOVA model included log-transformed (natural log) PK parameters T1/2z as dependent variable, and treatment condition, group, and period as independent variables.||1.041|0.932|
72493995|NCT03434977|144517045|OTHER||Ratio|1.047|||||TWO_SIDED|90.0|1.006|1.091||||||The shown data were the ratio of the fed conditions divided by the fasted conditions, taking anti-logs of the LS means difference (fed-fasted) or CI. The difference in the LS means between treatment conditions (fed-fasted) and the two-sided 90% CI were provided using a crossover ANOVA model. The ANOVA model included log-transformed (natural log) PK parameters MRTlast, ev as dependent variable, and treatment condition, group, and period as independent variables.||1.091|1.006|
72493996|NCT03434977|144517046|OTHER||Ratio|1.037|||||TWO_SIDED|90.0|0.996|1.081||||||The shown data were the ratio of the fed conditions divided by the fasted conditions, taking anti-logs of the LS means difference (fed-fasted) or CI. The difference in the LS means between treatment conditions (fed-fasted) and the two-sided 90% CI were provided using a crossover ANOVA model. The ANOVA model included log-transformed (natural log) PK parameters MRT∞, ev as dependent variable, and treatment condition, group, and period as independent variables.||1.081|0.996|
72557025|NCT03214588|144645332|SUPERIORITY||Least Squares Mean Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.105|||TWO_SIDED|90.0|-0.24|0.11||||||Change at Week 7, Cough||0.11|-0.24|
72557026|NCT03214588|144645332|SUPERIORITY||Least Squares Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.088|||TWO_SIDED|90.0|-0.05|0.25||||||Change at Week 7, Cough||0.25|-0.05|
72381974|NCT02718300|144272644|SUPERIORITY||GMR|1.062|||||TWO_SIDED|95.0|0.604|1.867|||||ANOVA was performed on dose-normalized PK parameters per dose level. The reference group was 5 mg QD.|Week 4||1.867|0.604|
72381975|NCT02718300|144272644|SUPERIORITY||GMR|1.504|||||TWO_SIDED|95.0|0.937|2.414|||||ANOVA was performed on dose-normalized PK parameters per dose level. The reference group was 5 mg QD.|Week 4||2.414|0.937|
72381976|NCT02718300|144272645|SUPERIORITY|||||||0.2873|||||||ANOVA|||Week 2||||0.2873
72381977|NCT02718300|144272645|SUPERIORITY||GMR|1.016|||||TWO_SIDED|95.0|0.773|1.336|||||ANOVA was performed on dose-normalized PK parameters per dose level. The reference group was 5 mg QD.|Week 2||1.336|0.773|
72381978|NCT02718300|144272645|SUPERIORITY||GMR|1.161|||||TWO_SIDED|95.0|0.943|1.429|||||ANOVA was performed on dose-normalized PK parameters per dose level. The reference group was 5 mg QD.|Week 2||1.429|0.943|
72381979|NCT02718300|144272645|SUPERIORITY|||||||0.1601|||||||ANOVA|||Week 4||||0.1601
72381980|NCT02718300|144272645|SUPERIORITY||GMR|0.992|||||TWO_SIDED|95.0|0.773|1.274|||||ANOVA was performed on dose-normalized PK parameters per dose level. The reference group was 5 mg QD.|Week 4||1.274|0.773|
72381981|NCT02718300|144272645|SUPERIORITY||GMR|1.177|||||TWO_SIDED|95.0|0.955|1.452|||||ANOVA was performed on dose-normalized PK parameters per dose level. The reference group was 5 mg QD.|Week 4||1.452|0.955|
72381982|NCT02718300|144272649|SUPERIORITY|||||||0.083|||||||ANOVA|||Day 1||||0.0830
72381983|NCT02718300|144272649|SUPERIORITY||GMR|1.218|||||TWO_SIDED|95.0|0.846|1.753|||||ANOVA was performed on dose-normalized PK parameters per dose level. The reference group was 5 mg QD.|Day 1||1.753|0.846|
72381984|NCT02718300|144272649|SUPERIORITY||GMR|0.957|||||TWO_SIDED|95.0|0.654|1.399|||||ANOVA was performed on dose-normalized PK parameters per dose level. The reference group was 5 mg QD.|Day 1||1.399|0.654|
72493997|NCT03434977|144517047|OTHER||Ratio|1.014|||||TWO_SIDED|90.0|0.959|1.071||||||The shown data were the ratio of the fed conditions divided by the fasted conditions, taking anti-logs of the LS means difference (fed-fasted) or CI. The difference in the LS means between treatment conditions (fed-fasted) and the two-sided 90% CI were provided using a crossover ANOVA model. The ANOVA model included log-transformed (natural log) PK parameters λz as dependent variable, and treatment condition, group, and period as independent variables.||1.071|0.959|
72493998|NCT03434977|144517048|OTHER||Ratio|1.003|||||TWO_SIDED|90.0|0.947|1.062||||||The shown data were the ratio of the fed conditions divided by the fasted conditions, taking anti-logs of the LS means difference (fed-fasted) or CI. The difference in the LS means between treatment conditions (fed-fasted) and the two-sided 90% CI were provided using a crossover ANOVA model. The ANOVA model included log-transformed (natural log) PK parameters CL/F as dependent variable, and treatment condition, group, and period as independent variables.||1.062|0.947|
72493999|NCT03434977|144517049|OTHER||Ratio|0.989|||||TWO_SIDED|90.0|0.916|1.068||||||The shown data were the ratio of the fed conditions divided by the fasted conditions, taking anti-logs of the LS means difference (fed-fasted) or CI. The difference in the LS means between treatment conditions (fed-fasted) and the two-sided 90% CI were provided using a crossover ANOVA model. The ANOVA model included log-transformed (natural log) PK parameters Vz/F as dependent variable, and treatment condition, group, and period as independent variables.||1.068|0.916|
72494000|NCT00217087|144517067|SUPERIORITY_OR_OTHER|||||||0.0098|TWO_SIDED||||||Fisher Exact|||||||0.0098
72494001|NCT00217087|144517068|SUPERIORITY_OR_OTHER|||||||0.34|TWO_SIDED||||||Chi-squared|||||||0.34
72494002|NCT00217087|144517069|SUPERIORITY_OR_OTHER|||||||0.2|TWO_SIDED||||||Chi-squared|the only participant who reported a decrease quality of life related that to a recent surgery not their esophagus.||||||0.2
72494003|NCT04770779|144517079|SUPERIORITY||Common Risk Difference on Response Rate|17.6||||0.0003|TWO_SIDED|95.0|8.0|27.2|||Mantel Haenszel|||The p-value is based on the Mantel-Haenszel stratum weighted method adjusting for randomization stratification factors.||27.2|8.0|0.0003
72494004|NCT04770779|144517080|SUPERIORITY||Common Risk Difference on Response Rate|11.1||||0.0003|TWO_SIDED|95.0|5.1|17.0|||Mantel Haenszel|||The p-value is based on the Mantel-Haenszel stratum weighted method adjusting for randomization stratification factors.||17.0|5.1|0.0003
72494005|NCT04770779|144517081|SUPERIORITY||Common Risk Difference on Response Rate|13.4|||<|0.0001|TWO_SIDED|95.0|7.7|19.1|||Mantel Haenszel|||The p-value is based on the Mantel-Haenszel stratum weighted method adjusting for randomization stratification factors.||19.1|7.7|<0.0001
72494006|NCT04770779|144517082|SUPERIORITY||Common Risk Difference on Response Rate|6.4||||0.0056|TWO_SIDED|95.0|1.9|10.9|||Mantel Haenszel|||The p-value is based on the Mantel-Haenszel stratum weighted method adjusting for randomization stratification factors.||10.9|1.9|0.0056
72494007|NCT02321436|144517099|OTHER|The treatment difference (Dysport® versus placebo) was tested using a non-parametric, two-sided, stratified log rank test.||||||0.0176||||||Significance level (α) = 5%|Log Rank|||||||0.0176
72494008|NCT02321436|144517099|OTHER|The treatment difference (Dysport® versus placebo) was tested using a non-parametric, two-sided, stratified Wilcoxon test.||||||0.048||||||Significance level (α) = 5%|Wilcoxon (Mann-Whitney)|||||||0.0480
72494009|NCT02321436|144517100|OTHER|Differences between treatment groups and p-values are based on an analysis of variance performed at each visit, taking into account treatment and spasticity status as fixed effects. Baseline value is value assessed at Visit 1.|Mean Difference (Final Values)|-1.0||||0.0005|TWO_SIDED|95.0|-1.54|-0.47||p value significance level = 5%|ANOVA|||Differences between treatment groups at Visit 2 (Week 4).||-0.47|-1.54|0.0005
72494010|NCT02321436|144517100|OTHER|Differences between treatment groups and p-values are based on an analysis of variance performed at each visit, taking into account treatment and spasticity status as fixed effects. Baseline value is value assessed at Visit 1.|Mean Difference (Final Values)|-1.05||||0.0007|TWO_SIDED|95.0|-1.63|-0.47||p value significance level = 5%|ANOVA|||Differences between treatment groups at Visit 3 (Week 6).||-0.47|-1.63|0.0007
72381985|NCT02718300|144272649|SUPERIORITY||GMR|0.943|||||TWO_SIDED|95.0|0.656|1.354|||||ANOVA was performed on dose-normalized PK parameters per dose level. The reference group was 5 mg QD.|Day 1||1.354|0.656|
72381986|NCT02718300|144272649|SUPERIORITY||GMR|0.867|||||TWO_SIDED|95.0|0.579|1.298|||||ANOVA was performed on dose-normalized PK parameters per dose level. The reference group was 5 mg QD.|Day 1||1.298|0.579|
72381987|NCT02718300|144272649|SUPERIORITY|||||||0.2402|||||||ANOVA|||Week 4||||0.2402
72381988|NCT02718300|144272649|SUPERIORITY||GMR|0.702|||||TWO_SIDED|95.0|0.461|1.069|||||ANOVA was performed on dose-normalized PK parameters per dose level. The reference group was 5 mg QD.|Week 4||1.069|0.461|
72381989|NCT02718300|144272649|SUPERIORITY||GMR|0.7|||||TWO_SIDED|95.0|0.456|1.073|||||ANOVA was performed on dose-normalized PK parameters per dose level. The reference group was 5 mg QD.|Week 4||1.073|0.456|
72557027|NCT03214588|144645332|SUPERIORITY||Least Squares Mean Difference|0.07|STANDARD_ERROR_OF_MEAN|0.106|||TWO_SIDED|90.0|-0.11|0.25||||||Change at Week 12, Cough||0.25|-0.11|
72381990|NCT02718300|144272649|SUPERIORITY||GMR|0.638|||||TWO_SIDED|95.0|0.428|0.951|||||ANOVA was performed on dose-normalized PK parameters per dose level. The reference group was 5 mg QD.|Week 4||0.951|0.428|
72381991|NCT02718300|144272649|SUPERIORITY||GMR|0.627|||||TWO_SIDED|95.0|0.397|0.99|||||ANOVA was performed on dose-normalized PK parameters per dose level. The reference group was 5 mg QD.|Week 4||0.990|0.397|
72381992|NCT02718300|144272650|SUPERIORITY|||||||0.0756|||||||Kruskal-Wallis|||Day 1||||0.0756
72381993|NCT02718300|144272650|SUPERIORITY|||||||0.0866|||||||Kruskal-Wallis|||Week 4||||0.0866
72381994|NCT02718300|144272651|SUPERIORITY|||||||0.4287|||||||ANOVA|||Day 1||||0.4287
72381995|NCT02718300|144272651|SUPERIORITY||GMR|1.272|||||TWO_SIDED|95.0|0.329|4.914|||||ANOVA was performed on dose-normalized PK parameters per dose level. The reference group was 5 mg QD.|Day 1||4.914|0.329|
72557028|NCT03214588|144645332|SUPERIORITY||Least Squares Mean Difference|0.12|STANDARD_ERROR_OF_MEAN|0.087|||TWO_SIDED|90.0|-0.03|0.26||||||Change at Week 12, Cough||0.26|-0.03|
72381996|NCT02718300|144272651|SUPERIORITY||GMR|1.036|||||TWO_SIDED|95.0|0.252|4.251|||||ANOVA was performed on dose-normalized PK parameters per dose level. The reference group was 5 mg QD.|Day 1||4.251|0.252|
72434352|NCT00708097|144381965|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|24.97|||<|0.0001|TWO_SIDED|95.0|20.27|29.66||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment and period with subject as a random effect.|Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|Null hypothesis considered population means of the treatments in comparison, to be equal with respect to percent SMH. Statistical tests were 2-sided with a significance level of 0.05.||29.66|20.27|<0.0001
72557029|NCT03214588|144645332|SUPERIORITY||Least Squares Mean Difference|0.08|STANDARD_ERROR_OF_MEAN|0.1|||TWO_SIDED|90.0|-0.09|0.25||||||Change at Week 2, Speech||0.25|-0.09|
72557030|NCT03214588|144645332|SUPERIORITY||Least Squares Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.083|||TWO_SIDED|90.0|-0.04|0.24||||||Change at Week 2, Speech||0.24|-0.04|
72381997|NCT02718300|144272651|SUPERIORITY||GMR|0.702|||||TWO_SIDED|95.0|0.18|2.731|||||ANOVA was performed on dose-normalized PK parameters per dose level. The reference group was 5 mg QD.|Day 1||2.731|0.180|
72381998|NCT02718300|144272651|SUPERIORITY||GMR|0.525|||||TWO_SIDED|95.0|0.118|2.348|||||ANOVA was performed on dose-normalized PK parameters per dose level. The reference group was 5 mg QD.|Day 1||2.348|0.118|
72381999|NCT02718300|144272651|SUPERIORITY|||||||0.9788|||||||ANOVA|||Week 4||||0.9788
72382000|NCT02718300|144272651|SUPERIORITY||GMR|0.879|||||TWO_SIDED|95.0|0.198|3.896|||||ANOVA was performed on dose-normalized PK parameters per dose level. The reference group was 5 mg QD.|Week 4||3.896|0.198|
72382001|NCT02718300|144272651|SUPERIORITY||GMR|1.225|||||TWO_SIDED|95.0|0.27|5.56|||||ANOVA was performed on dose-normalized PK parameters per dose level. The reference group was 5 mg QD.|Week 4||5.560|0.270|
72382002|NCT02718300|144272651|SUPERIORITY||GMR|0.918|||||TWO_SIDED|95.0|0.221|3.821|||||ANOVA was performed on dose-normalized PK parameters per dose level. The reference group was 5 mg QD.|Week 4||3.821|0.221|
72382003|NCT02718300|144272651|SUPERIORITY||GMR|0.853|||||TWO_SIDED|95.0|0.169|4.299|||||ANOVA was performed on dose-normalized PK parameters per dose level. The reference group was 5 mg QD.|Week 4||4.299|0.169|
72382004|NCT02718300|144272652|SUPERIORITY|||||||0.1208|||||||ANOVA|||Day 1||||0.1208
72382005|NCT02718300|144272652|SUPERIORITY||GMR|1.251|||||TWO_SIDED|95.0|0.832|1.879|||||ANOVA was performed on dose-normalized PK parameters per dose level. The reference group was 5 mg QD.|Day 1||1.879|0.832|
72382006|NCT02718300|144272652|SUPERIORITY||GMR|0.992|||||TWO_SIDED|95.0|0.649|1.518|||||ANOVA was performed on dose-normalized PK parameters per dose level. The reference group was 5 mg QD.|Day 1||1.518|0.649|
72382007|NCT02718300|144272652|SUPERIORITY||GMR|0.967|||||TWO_SIDED|95.0|0.645|1.45|||||ANOVA was performed on dose-normalized PK parameters per dose level. The reference group was 5 mg QD.|Day 1||1.450|0.645|
72382008|NCT02718300|144272652|SUPERIORITY||GMR|0.86|||||TWO_SIDED|95.0|0.548|1.35|||||ANOVA was performed on dose-normalized PK parameters per dose level. The reference group was 5 mg QD.|Day 1||1.350|0.548|
72382009|NCT02718300|144272652|SUPERIORITY|||||||0.3218|||||||ANOVA|||Week 4||||0.3218
72382010|NCT02718300|144272652|SUPERIORITY||GMR|0.761|||||TWO_SIDED|95.0|0.482|1.2|||||ANOVA was performed on dose-normalized PK parameters per dose level. The reference group was 5 mg QD.|Week 4||1.200|0.482|
72382011|NCT02718300|144272652|SUPERIORITY||GMR|0.803|||||TWO_SIDED|95.0|0.506|1.277|||||ANOVA was performed on dose-normalized PK parameters per dose level. The reference group was 5 mg QD.|Week 4||1.277|0.506|
72382012|NCT02718300|144272652|SUPERIORITY||GMR|0.667|||||TWO_SIDED|95.0|0.432|1.028|||||ANOVA was performed on dose-normalized PK parameters per dose level. The reference group was 5 mg QD.|Week 4||1.028|0.432|
72382013|NCT02718300|144272652|SUPERIORITY||GMR|0.64|||||TWO_SIDED|95.0|0.39|1.051|||||ANOVA was performed on dose-normalized PK parameters per dose level. The reference group was 5 mg QD.|Week 4||1.051|0.390|
72382014|NCT00729924|144272663|SUPERIORITY_OR_OTHER|||||||0.43|TWO_SIDED|||||The p-value is not adjusted for multiple comparisons.|Wilcoxon (Mann-Whitney)|||The hypothesis was that the ratio of the 4-hour CSF concentration value to the partial plasma area-under-the-curve 0-4h value would differ between participants with ABCB1 C/C and T/T genotypes.||||0.43
72382015|NCT00729924|144272664|SUPERIORITY_OR_OTHER|||||||0.43|TWO_SIDED|||||The p-value is not adjusted for multiple comparisons.|Wilcoxon (Mann-Whitney)|||We explored post-hoc whether the ratio of the 4-hour CSF concentration value to the 2-hour plasma concentration differs between participants with ABCB1 C/C and T/T genotypes.||||0.43
72382016|NCT00085709|144272665|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Regression, Cox|The interim analysis only reported a p-value for testing whether the hazard ratio was not equal to 1.5.||Interim futility analysis of the alternative hypothesis for disease-free survival. The design specified a hazard ratio of (observation: GO) of 1.5.||||<0.001
72382017|NCT00085709|144272666|SUPERIORITY_OR_OTHER||||||<|0.0025||95.0|||||Test of difference of proportions|||Interim futility analysis alternative hypothesis based on the design specification that the 7+3+GO arm would have a 12% increase in CR rate.||||<0.0025
72382018|NCT03646643|144272668|SUPERIORITY||Hazard Ratio (HR)|0.12||||0.047|TWO_SIDED|95.0|0.02|0.97||A priori threshold \<0.05. Multiple comparisons adjustments: not needed.|Log Rank||The distal CS to LA connection elimination group had fewer recurrences (6.7%) compared with the standard group (46.7%), which translated to an 88% lower hazard of recurrence compared with the standard group.|Power calculation: assuming alpha 0.05, power 0.8, 1:1 randomization, and estimated relative risk of 14.4 for AF susceptibility with rate-dependent CS-LA conduction block, we anticipated a minimum sample size of 6 patients per group would be necessary to detect a difference using the log-rank test. Additional patients were recruited to account for potential losses to follow-up and a smaller detectable difference.||0.97|0.02|0.047
72494011|NCT02321436|144517100|OTHER|Differences between treatment groups and p-values are based on an analysis of variance performed at each visit, taking into account treatment and spasticity status as fixed effects. Baseline value is value assessed at Visit 1.|Mean Difference (Final Values)|-1.05||||0.0006|TWO_SIDED|95.0|-1.62|-0.48||p value significance level = 5%|ANOVA|||Differences between treatment groups at Visit 4 (Week 8).||-0.48|-1.62|0.0006
72557031|NCT03214588|144645332|SUPERIORITY||Least Squares Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.071|||TWO_SIDED|90.0|-0.16|0.08||||||Change at Week 7, Speech||0.08|-0.16|
72557032|NCT03214588|144645332|SUPERIORITY||Least Squares Mean Difference|0.07|STANDARD_ERROR_OF_MEAN|0.06|||TWO_SIDED|90.0|-0.03|0.17||||||Change at Week 7, Speech||0.17|-0.03|
72557033|NCT03214588|144645332|SUPERIORITY||Least Squares Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.095|||TWO_SIDED|90.0|-0.16|0.16||||||Change at Week 12, Speech||0.16|-0.16|
72557034|NCT03214588|144645332|SUPERIORITY||Least Squares Mean Difference|0.09|STANDARD_ERROR_OF_MEAN|0.079|||TWO_SIDED|90.0|-0.04|0.22||||||Change at Week 12, Speech||0.22|-0.04|
72557035|NCT03214588|144645332|SUPERIORITY||Least Squares Mean Difference|0.07|STANDARD_ERROR_OF_MEAN|0.131|||TWO_SIDED|90.0|-0.14|0.29||||||Change at Week 2, Right Finger to Finger Test||0.29|-0.14|
72557036|NCT03214588|144645332|SUPERIORITY||Least Squares Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.108|||TWO_SIDED|90.0|-0.22|0.14||||||Change at Week 2, Right Finger to Finger Test||0.14|-0.22|
72557037|NCT03214588|144645332|SUPERIORITY||Least Squares Mean Difference|0.07|STANDARD_ERROR_OF_MEAN|0.122|||TWO_SIDED|90.0|-0.13|0.28||||||Change at Week 7, Right Finger to Finger Test||0.28|-0.13|
72557038|NCT03214588|144645332|SUPERIORITY||Least Squares Mean Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.103|||TWO_SIDED|90.0|-0.24|0.11||||||Change at Week 7, Right Finger to Finger Test||0.11|-0.24|
72382019|NCT04131556|144272669|EQUIVALENCE|Equivalence analysis based on confidence intervals (CIs). If the 90% CIs of the geometric mean ratios were within (0.8, 1.25), bioequivalence between the two formulations (test powder for oral suspension versus reference tablet) was to be claimed. A linear mixed effect ANOVA model with treatment, period, sequence as fixed effects and participant within sequence as a random effect was used to fit to ln-transformed PK parameters.|% Ratio of Geometric least square means|67.76|||||TWO_SIDED|90.0|59.5|77.16|||ANOVA|||||77.16|59.50|
72557039|NCT03214588|144645332|SUPERIORITY||Least Squares Mean Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.126|||TWO_SIDED|90.0|-0.3|0.12||||||Change at Week 12, Right Finger to Finger Test||0.12|-0.30|
72557040|NCT03214588|144645332|SUPERIORITY||Least Squares Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.104|||TWO_SIDED|90.0|-0.32|0.03||||||Change at Week 12, Right Finger to Finger Test||0.03|-0.32|
72434353|NCT00708097|144381965|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|3.98||||0.0925|TWO_SIDED|95.0|-0.66|8.61||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment and period with subject as a random effect.|Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|Null hypothesis considered population means of the treatments in comparison, to be equal with respect to percent SMH. Statistical tests were 2-sided with a significance level of 0.05.||8.61|-0.66|0.0925
72557041|NCT03214588|144645332|SUPERIORITY||Least Squares Mean Difference|0.09|STANDARD_ERROR_OF_MEAN|0.142|||TWO_SIDED|90.0|-0.15|0.33||||||Change at Week 2, Left Finger to Finger Test||0.33|-0.15|
72557042|NCT03214588|144645332|SUPERIORITY||Least Squares Mean Difference|0.04|STANDARD_ERROR_OF_MEAN|0.117|||TWO_SIDED|90.0|-0.16|0.23||||||Change at Week 2, Left Finger to Finger Test||0.23|-0.16|
72557043|NCT03214588|144645332|SUPERIORITY||Least Squares Mean Difference|0.03|STANDARD_ERROR_OF_MEAN|0.123|||TWO_SIDED|90.0|-0.18|0.23||||||Change at Week 7, Left Finger to Finger Test||0.23|-0.18|
72557044|NCT03214588|144645332|SUPERIORITY||Least Squares Mean Difference|0.03|STANDARD_ERROR_OF_MEAN|0.104|||TWO_SIDED|90.0|-0.15|0.2||||||Change at Week 7, Left Finger to Finger Test||0.20|-0.15|
72557045|NCT03214588|144645332|SUPERIORITY||Least Squares Mean Difference|0.09|STANDARD_ERROR_OF_MEAN|0.158|||TWO_SIDED|90.0|-0.17|0.36||||||Change at Week 12, Left Finger to Finger Test||0.36|-0.17|
72557046|NCT03214588|144645332|SUPERIORITY||Least Squares Mean Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.13|||TWO_SIDED|90.0|-0.3|0.13||||||Change at Week 12, Left Finger to Finger Test||0.13|-0.30|
72557047|NCT03214588|144645332|SUPERIORITY||Least Squares Mean Difference|0.29|STANDARD_ERROR_OF_MEAN|0.145|||TWO_SIDED|90.0|0.04|0.53||||||Change at Week 2, Right Nose to Finger Test||0.53|0.04|
72557048|NCT03214588|144645332|SUPERIORITY||Least Squares Mean Difference|0.14|STANDARD_ERROR_OF_MEAN|0.118|||TWO_SIDED|90.0|-0.06|0.33||||||Change at Week 2, Right Nose to Finger Test||0.33|-0.06|
72557049|NCT03214588|144645332|SUPERIORITY||Least Squares Mean Difference|0.07|STANDARD_ERROR_OF_MEAN|0.174|||TWO_SIDED|90.0|-0.22|0.37||||||Change at Week 7, Right Nose to Finger Test||0.37|-0.22|
72557050|NCT03214588|144645332|SUPERIORITY||Least Squares Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.146|||TWO_SIDED|90.0|-0.32|0.16||||||Change at Week 7, Right Nose to Finger Test||0.16|-0.32|
72557051|NCT03214588|144645332|SUPERIORITY||Least Squares Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.166|||TWO_SIDED|90.0|-0.43|0.12||||||Change at Week 12, Right Nose to Finger Test||0.12|-0.43|
72557052|NCT03214588|144645332|SUPERIORITY||Least Squares Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.136|||TWO_SIDED|90.0|-0.23|0.23||||||Change at Week 12, Right Nose to Finger Test||0.23|-0.23|
72557053|NCT03214588|144645332|SUPERIORITY||Least Squares Mean Difference|0.13|STANDARD_ERROR_OF_MEAN|0.161|||TWO_SIDED|90.0|-0.14|0.4||||||Change at Week 2, Left Nose to Finger Test||0.40|-0.14|
72557054|NCT03214588|144645332|SUPERIORITY||Least Squares Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.133|||TWO_SIDED|90.0|-0.12|0.33||||||Change at Week 2, Left Nose to Finger Test||0.33|-0.12|
72557055|NCT03214588|144645332|SUPERIORITY||Least Squares Mean Difference|0.17|STANDARD_ERROR_OF_MEAN|0.157|||TWO_SIDED|90.0|-0.09|0.43||||||Change at Week 7, Left Nose to Finger Test||0.43|-0.09|
72557056|NCT03214588|144645332|SUPERIORITY||Least Squares Mean Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.134|||TWO_SIDED|90.0|-0.36|0.09||||||Change at Week 7, Left Nose to Finger Test||0.09|-0.36|
72557057|NCT03214588|144645332|SUPERIORITY||Least Squares Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.169|||TWO_SIDED|90.0|-0.29|0.27||||||Change at Week 12, Left Nose to Finger Test||0.27|-0.29|
72557058|NCT03214588|144645332|SUPERIORITY||Least Squares Mean Difference|0.03|STANDARD_ERROR_OF_MEAN|0.141|||TWO_SIDED|90.0|-0.21|0.27||||||Change at Week 12, Left Nose to Finger Test||0.27|-0.21|
72557059|NCT03214588|144645332|SUPERIORITY||Least Squares Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.176|||TWO_SIDED|90.0|-0.33|0.26||||||Change at Week 2, Right Dysmetria Test||0.26|-0.33|
72557060|NCT03214588|144645332|SUPERIORITY||Least Squares Mean Difference|0.12|STANDARD_ERROR_OF_MEAN|0.145|||TWO_SIDED|90.0|-0.12|0.36||||||Change at Week 2, Right Dysmetria Test||0.36|-0.12|
72557061|NCT03214588|144645332|SUPERIORITY||Least Squares Mean Difference|0.12|STANDARD_ERROR_OF_MEAN|0.217|||TWO_SIDED|90.0|-0.25|0.48||||||Change at Week 7, Right Dysmetria Test||0.48|-0.25|
72557062|NCT03214588|144645332|SUPERIORITY||Least Squares Mean Difference|0.17|STANDARD_ERROR_OF_MEAN|0.183|||TWO_SIDED|90.0|-0.14|0.47||||||Change at Week 7, Right Dysmetria Test||0.47|-0.14|
72557063|NCT03214588|144645332|SUPERIORITY||Least Squares Mean Difference|0.11|STANDARD_ERROR_OF_MEAN|0.221|||TWO_SIDED|90.0|-0.26|0.48||||||Change at Week 12, Right Dysmetria Test||0.48|-0.26|
72557064|NCT03214588|144645332|SUPERIORITY||Least Squares Mean Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.183|||TWO_SIDED|90.0|-0.36|0.25||||||Change at Week 12, Right Dysmetria Test||0.25|-0.36|
72557065|NCT03214588|144645332|SUPERIORITY||Least Squares Mean Difference|0.29|STANDARD_ERROR_OF_MEAN|0.185|||TWO_SIDED|90.0|-0.02|0.6||||||Change at Week 2, Left Dysmetria Test||0.60|-0.02|
72557066|NCT03214588|144645332|SUPERIORITY||Least Squares Mean Difference|0.15|STANDARD_ERROR_OF_MEAN|0.153|||TWO_SIDED|90.0|-0.1|0.41||||||Change at Week 2, Left Dysmetria Test||0.41|-0.10|
72557067|NCT03214588|144645332|SUPERIORITY||Least Squares Mean Difference|-0.25|STANDARD_ERROR_OF_MEAN|0.228|||TWO_SIDED|90.0|-0.63|0.13||||||Change at Week 7, Left Dysmetria Test||0.13|-0.63|
72557068|NCT03214588|144645332|SUPERIORITY||Least Squares Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.192|||TWO_SIDED|90.0|-0.47|0.18||||||Change at Week 7, Left Dysmetria Test||0.18|-0.47|
72557069|NCT03214588|144645332|SUPERIORITY||Least Squares Mean Difference|0.06|STANDARD_ERROR_OF_MEAN|0.254|||TWO_SIDED|90.0|-0.37|0.48||||||Change at Week 12, Left Dysmetria Test||0.48|-0.37|
72557070|NCT03214588|144645332|SUPERIORITY||Least Squares Mean Difference|0.23|STANDARD_ERROR_OF_MEAN|0.209|||TWO_SIDED|90.0|-0.11|0.58||||||Change at Week 12, Left Dysmetria Test||0.58|-0.11|
72557071|NCT03214588|144645332|SUPERIORITY||Least Squares Mean Difference|0.22|STANDARD_ERROR_OF_MEAN|0.17|||TWO_SIDED|90.0|-0.06|0.51||||||Change at Week 2, RAM of Right Hands||0.51|-0.06|
72557072|NCT03214588|144645332|SUPERIORITY||Least Squares Mean Difference|0.11|STANDARD_ERROR_OF_MEAN|0.141|||TWO_SIDED|90.0|-0.12|0.35||||||Change at Week 2, RAM of Right Hands||0.35|-0.12|
72434354|NCT00708097|144381965|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|20.03|||<|0.0001|TWO_SIDED|95.0|15.35|24.7||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment and period with subject as a random effect.|Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|Null hypothesis considered population means of the treatments in comparison, to be equal with respect to percent SMH. Statistical tests were 2-sided with a significance level of 0.05.||24.70|15.35|<0.0001
72434355|NCT00708097|144381965|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|16.05|||<|0.0001|TWO_SIDED|95.0|11.36|20.74||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment and period with subject as a random effect.|Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|Null hypothesis considered population means of the treatments in comparison, to be equal with respect to percent SMH. Statistical tests were 2-sided with a significance level of 0.05.||20.74|11.36|<0.0001
72557073|NCT03214588|144645332|SUPERIORITY||Least Squares Mean Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.204|||TWO_SIDED|90.0|-0.41|0.28||||||Change at Week 7, RAM of Right Hands||0.28|-0.41|
72557074|NCT03214588|144645332|SUPERIORITY||Least Squares Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.172|||TWO_SIDED|90.0|-0.29|0.29||||||Change at Week 7, RAM of Right Hands||0.29|-0.29|
72557075|NCT03214588|144645332|SUPERIORITY||Least Squares Mean Difference|0.19|STANDARD_ERROR_OF_MEAN|0.187|||TWO_SIDED|90.0|-0.12|0.51||||||Change at Week 12, RAM of Right Hands||0.51|-0.12|
72557076|NCT03214588|144645332|SUPERIORITY||Least Squares Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.156|||TWO_SIDED|90.0|-0.31|0.21||||||Change at Week 12, RAM of Right Hands||0.21|-0.31|
72557077|NCT03214588|144645332|SUPERIORITY||Least Squares Mean Difference|0.08|STANDARD_ERROR_OF_MEAN|0.141|||TWO_SIDED|90.0|-0.15|0.32||||||Change at Week 2, RAM of Left Hands||0.32|-0.15|
72557078|NCT03214588|144645332|SUPERIORITY||Least Squares Mean Difference|0.08|STANDARD_ERROR_OF_MEAN|0.116|||TWO_SIDED|90.0|-0.12|0.27||||||Change at Week 2, RAM of Left Hands||0.27|-0.12|
72557079|NCT03214588|144645332|SUPERIORITY||Least Squares Mean Difference|0.08|STANDARD_ERROR_OF_MEAN|0.209|||TWO_SIDED|90.0|-0.27|0.43||||||Change at Week 7, RAM of Left Hands||0.43|-0.27|
72557080|NCT03214588|144645332|SUPERIORITY||Least Squares Mean Difference|0.12|STANDARD_ERROR_OF_MEAN|0.176|||TWO_SIDED|90.0|-0.17|0.42||||||Change at Week 7, RAM of Left Hands||0.42|-0.17|
72557081|NCT03214588|144645332|SUPERIORITY||Least Squares Mean Difference|0.31|STANDARD_ERROR_OF_MEAN|0.159|||TWO_SIDED|90.0|0.04|0.58||||||Change at Week 12, RAM of Left Hand||0.58|0.04|
72557082|NCT03214588|144645332|SUPERIORITY||Least Squares Mean Difference|0.21|STANDARD_ERROR_OF_MEAN|0.132|||TWO_SIDED|90.0|-0.01|0.43||||||Change at Week 12, RAM of Left Hand||0.43|-0.01|
72557083|NCT03214588|144645332|SUPERIORITY||Least Squares Mean Difference|0.44|STANDARD_ERROR_OF_MEAN|0.201|||TWO_SIDED|90.0|0.1|0.77||||||Change at Week 2, Right Finger Taps||0.77|0.10|
72557084|NCT03214588|144645332|SUPERIORITY||Least Squares Mean Difference|0.16|STANDARD_ERROR_OF_MEAN|0.168|||TWO_SIDED|90.0|-0.12|0.44||||||Change at Week 2, Right Finger Taps||0.44|-0.12|
72557085|NCT03214588|144645332|SUPERIORITY||Least Squares Mean Difference|0.22|STANDARD_ERROR_OF_MEAN|0.227|||TWO_SIDED|90.0|-0.16|0.6||||||Change at Week 7, Right Finger Taps||0.60|-0.16|
72557086|NCT03214588|144645332|SUPERIORITY||Least Squares Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.193|||TWO_SIDED|90.0|-0.33|0.31||||||Change at Week 7, Right Finger Taps||0.31|-0.33|
72557087|NCT03214588|144645332|SUPERIORITY||Least Squares Mean Difference|0.17|STANDARD_ERROR_OF_MEAN|0.233|||TWO_SIDED|90.0|-0.22|0.56||||||Change at Week 12, Right Finger Taps||0.56|-0.22|
72618656|NCT01026038|144768107|SUPERIORITY_OR_OTHER||GMC ratio|1.37|||||TWO_SIDED|95.0|0.6|3.14||||||Serotype 19F: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||3.14|0.60|
72557088|NCT03214588|144645332|SUPERIORITY||Least Squares Mean Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.194|||TWO_SIDED|90.0|-0.39|0.26||||||Change at Week 12, Right Finger Taps||0.26|-0.39|
72557089|NCT03214588|144645332|SUPERIORITY||Least Squares Mean Difference|0.5|STANDARD_ERROR_OF_MEAN|0.223|||TWO_SIDED|90.0|0.12|0.87||||||Change at Week 2, Left Finger Taps||0.87|0.12|
72557090|NCT03214588|144645332|SUPERIORITY||Least Squares Mean Difference|0.05|STANDARD_ERROR_OF_MEAN|0.183|||TWO_SIDED|90.0|-0.25|0.36||||||Change at Week 2, Left Finger Taps||0.36|-0.25|
72557091|NCT03214588|144645332|SUPERIORITY||Least Squares Mean Difference|0.59|STANDARD_ERROR_OF_MEAN|0.218|||TWO_SIDED|90.0|0.22|0.95||||||Change at Week 7, Left Finger Taps||0.95|0.22|
72557092|NCT03214588|144645332|SUPERIORITY||Least Squares Mean Difference|0.16|STANDARD_ERROR_OF_MEAN|0.184|||TWO_SIDED|90.0|-0.15|0.47||||||Change at Week 7, Left Finger Taps||0.47|-0.15|
72557093|NCT03214588|144645332|SUPERIORITY||Least Squares Mean Difference|0.57|STANDARD_ERROR_OF_MEAN|0.272|||TWO_SIDED|90.0|0.11|1.02||||||Change at Week 12, Left Finger Taps||1.02|0.11|
72557094|NCT03214588|144645332|SUPERIORITY||Least Squares Mean Difference|0.33|STANDARD_ERROR_OF_MEAN|0.224|||TWO_SIDED|90.0|-0.04|0.71||||||Change at Week 12, Left Finger Taps||0.71|-0.04|
72557095|NCT03214588|144645332|SUPERIORITY||Least Squares Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|0.193|||TWO_SIDED|90.0|-0.12|0.53||||||Change at Week 2, Right Heel Along Shin Slide||0.53|-0.12|
72557096|NCT03214588|144645332|SUPERIORITY||Least Squares Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.161|||TWO_SIDED|90.0|-0.26|0.27||||||Change at Week 2, Right Heel Along Shin Slide||0.27|-0.26|
72557097|NCT03214588|144645332|SUPERIORITY||Least Squares Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.251|||TWO_SIDED|90.0|-0.56|0.28||||||Change at Week 7, Right Heel Along Shin Slide||0.28|-0.56|
72557098|NCT03214588|144645332|SUPERIORITY||Least Squares Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.214|||TWO_SIDED|90.0|-0.53|0.19||||||Change at Week 7, Right Heel Along Shin Slide||0.19|-0.53|
72557099|NCT03214588|144645332|SUPERIORITY||Least Squares Mean Difference|0.33|STANDARD_ERROR_OF_MEAN|0.27|||TWO_SIDED|90.0|-0.12|0.78||||||Change at Week 12,Right Heel Along Shin Slide||0.78|-0.12|
72557100|NCT03214588|144645332|SUPERIORITY||Least Squares Mean Difference|0.13|STANDARD_ERROR_OF_MEAN|0.226|||TWO_SIDED|90.0|-0.25|0.51||||||Change at Week 12,Right Heel Along Shin Slide||0.51|-0.25|
72557101|NCT03214588|144645332|SUPERIORITY||Least Squares Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.205|||TWO_SIDED|90.0|-0.51|0.18||||||Change at Week 2, Left Heel Along Shin Slide||0.18|-0.51|
72557102|NCT03214588|144645332|SUPERIORITY||Least Squares Mean Difference|0.03|STANDARD_ERROR_OF_MEAN|0.166|||TWO_SIDED|90.0|-0.25|0.31||||||Change at Week 2, Left Heel Along Shin Slide||0.31|-0.25|
72557103|NCT03214588|144645332|SUPERIORITY||Least Squares Mean Difference|-0.31|STANDARD_ERROR_OF_MEAN|0.224|||TWO_SIDED|90.0|-0.68|0.07||||||Change at Week 7, Left Heel Along Shin Slide||0.07|-0.68|
72557104|NCT03214588|144645332|SUPERIORITY||Least Squares Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.188|||TWO_SIDED|90.0|-0.48|0.15||||||Change at Week 7, Left Heel Along Shin Slide||0.15|-0.48|
72557105|NCT03214588|144645332|SUPERIORITY||Least Squares Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.254|||TWO_SIDED|90.0|-0.45|0.4||||||Change at Week 12, Left Heel Along Shin Slide||0.40|-0.45|
72557106|NCT03214588|144645332|SUPERIORITY||Least Squares Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.209|||TWO_SIDED|90.0|-0.34|0.36||||||Change at Week 12, Left Heel Along Shin Slide||0.36|-0.34|
72557107|NCT03214588|144645332|SUPERIORITY||Least Squares Mean Difference|0.22|STANDARD_ERROR_OF_MEAN|0.187|||TWO_SIDED|90.0|-0.1|0.53||||||Change at Week 2, Right Heel Along Shin Tap||0.53|-0.10|
72557108|NCT03214588|144645332|SUPERIORITY||Least Squares Mean Difference|0.43|STANDARD_ERROR_OF_MEAN|0.155|||TWO_SIDED|90.0|0.17|0.69||||||Change at Week 2, Right Heel Along Shin Tap||0.69|0.17|
72557109|NCT03214588|144645332|SUPERIORITY||Least Squares Mean Difference|-0.27|STANDARD_ERROR_OF_MEAN|0.272|||TWO_SIDED|90.0|-0.72|0.19||||||Change at Week 7, Right Heel Along Shin Tap||0.19|-0.72|
72557110|NCT03214588|144645332|SUPERIORITY||Least Squares Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.231|||TWO_SIDED|90.0|-0.38|0.39||||||Change at Week 7, Right Heel Along Shin Tap||0.39|-0.38|
72557111|NCT03214588|144645332|SUPERIORITY||Least Squares Mean Difference|0.14|STANDARD_ERROR_OF_MEAN|0.222|||TWO_SIDED|90.0|-0.23|0.51||||||Change at Week 12, Right Heel Along Shin Tap||0.51|-0.23|
72557112|NCT03214588|144645332|SUPERIORITY||Least Squares Mean Difference|0.33|STANDARD_ERROR_OF_MEAN|0.186|||TWO_SIDED|90.0|0.02|0.64||||||Change at Week 12, Right Heel Along Shin Tap||0.64|0.02|
72557113|NCT03214588|144645332|SUPERIORITY||Least Squares Mean Difference|0.16|STANDARD_ERROR_OF_MEAN|0.199|||TWO_SIDED|90.0|-0.17|0.5||||||Change at Week 2, Left Heel Along Shin Tap||0.50|-0.17|
72557114|NCT03214588|144645332|SUPERIORITY||Least Squares Mean Difference|0.34|STANDARD_ERROR_OF_MEAN|0.164|||TWO_SIDED|90.0|0.06|0.61||||||Change at Week 2, Left Heel Along Shin Tap||0.61|0.06|
72557115|NCT03214588|144645332|SUPERIORITY||Least Squares Mean Difference|0.37|STANDARD_ERROR_OF_MEAN|0.277|||TWO_SIDED|90.0|-0.09|0.84||||||Change at Week 7, Left Heel Along Shin Tap||0.84|-0.09|
72557116|NCT03214588|144645332|SUPERIORITY||Least Squares Mean Difference|0.21|STANDARD_ERROR_OF_MEAN|0.234|||TWO_SIDED|90.0|-0.19|0.6||||||Change at Week 7, Left Heel Along Shin Tap||0.60|-0.19|
72557117|NCT03214588|144645332|SUPERIORITY||Least Squares Mean Difference|0.31|STANDARD_ERROR_OF_MEAN|0.303|||TWO_SIDED|90.0|-0.2|0.82||||||Change at Week 12, Left Heel Along Shin Tap||0.82|-0.20|
72557118|NCT03214588|144645332|SUPERIORITY||Least Squares Mean Difference|0.25|STANDARD_ERROR_OF_MEAN|0.25|||TWO_SIDED|90.0|-0.17|0.67||||||Change at Week 12, Left Heel Along Shin Tap||0.67|-0.17|
72557119|NCT03214588|144645332|SUPERIORITY||Least Squares Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|0.18|||TWO_SIDED|90.0|-0.1|0.5||||||Change at Week 2, Siting Posture||0.5|-0.1|
72557120|NCT03214588|144645332|SUPERIORITY||Least Squares Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|0.15|||TWO_SIDED|90.0|-0.1|0.4||||||Change at Week 2, Siting Posture||0.4|-0.1|
72557121|NCT03214588|144645332|SUPERIORITY||Least Squares Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.18|||TWO_SIDED|90.0|-0.4|0.2||||||Change at Week 7, Siting Posture||0.2|-0.4|
72557122|NCT03214588|144645332|SUPERIORITY||Least Squares Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|0.15|||TWO_SIDED|90.0|0.0|0.5||||||Change at Week 7, Siting Posture||0.5|0.0|
72557123|NCT03214588|144645332|SUPERIORITY||Least Squares Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.19|||TWO_SIDED|90.0|-0.5|0.2||||||Change at Week 12, Siting Posture||0.2|-0.5|
72557124|NCT03214588|144645332|SUPERIORITY||Least Squares Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.16|||TWO_SIDED|90.0|-0.2|0.3||||||Change at Week 12, Siting Posture||0.3|-0.2|
72557125|NCT03214588|144645332|SUPERIORITY||Least Squares Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.25|||TWO_SIDED|90.0|-0.4|0.4||||||Change at Week 2, SFA - TTA||0.4|-0.4|
72557126|NCT03214588|144645332|SUPERIORITY||Least Squares Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.2|||TWO_SIDED|90.0|-0.3|0.3||||||Change at Week 2, SFA - TTA||0.3|-0.3|
72557127|NCT03214588|144645332|SUPERIORITY||Least Squares Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.2|||TWO_SIDED|90.0|-0.4|0.2||||||Change at Week 7, SFA - TTA||0.2|-0.4|
72557128|NCT03214588|144645332|SUPERIORITY||Least Squares Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.17|||TWO_SIDED|90.0|-0.5|0.1||||||Change at Week 7, SFA - TTA||0.1|-0.5|
72557129|NCT03214588|144645332|SUPERIORITY||Least Squares Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.22|||TWO_SIDED|90.0|-0.3|0.4||||||Change at Week 12, SFA - TTA||0.4|-0.3|
72557130|NCT03214588|144645332|SUPERIORITY||Least Squares Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.19|||TWO_SIDED|90.0|-0.2|0.4||||||Change at Week 12, SFA - TTA||0.4|-0.2|
72557131|NCT03214588|144645332|SUPERIORITY||Least Squares Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.11|||TWO_SIDED|90.0|-0.1|0.3||||||Change at Week 2, SFA (Eyes Closed) - TTA||0.3|-0.1|
72557132|NCT03214588|144645332|SUPERIORITY||Least Squares Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.09|||TWO_SIDED|90.0|-0.2|0.1||||||Change at Week 2, SFA (Eyes Closed) - TTA||0.1|-0.2|
72557133|NCT03214588|144645332|SUPERIORITY||Least Squares Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.19|||TWO_SIDED|90.0|-0.4|0.2||||||Change at Week 7, SFA (Eyes Closed) - TTA||0.2|-0.4|
72557134|NCT03214588|144645332|SUPERIORITY||Least Squares Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.16|||TWO_SIDED|90.0|-0.4|0.1||||||Change at Week 7, SFA (Eyes Closed) - TTA||0.1|-0.4|
72557135|NCT03214588|144645332|SUPERIORITY||Least Squares Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.23|||TWO_SIDED|90.0|-0.3|0.4||||||Change at Week 12, SFA (Eyes Closed) - TTA||0.4|-0.3|
72557136|NCT03214588|144645332|SUPERIORITY||Least Squares Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.19|||TWO_SIDED|90.0|-0.5|0.1||||||Change at Week 12, SFA (Eyes Closed) - TTA||0.1|-0.5|
72557137|NCT03214588|144645332|SUPERIORITY||Least Squares Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.32|||TWO_SIDED|90.0|-0.8|0.2||||||Change at Week 2, SFT - TTA||0.2|-0.8|
72557138|NCT03214588|144645332|SUPERIORITY||Least Squares Mean Difference|0.4|STANDARD_ERROR_OF_MEAN|0.26|||TWO_SIDED|90.0|0.0|0.8||||||Change at Week 2, SFT - TTA||0.8|0.0|
72434356|NCT00708097|144381966|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-2.01||||0.9697|TWO_SIDED|95.0|-106.34|102.32||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment and period with subject as a random effect.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered population means of the treatments in comparison, to be equal with respect to EFU. Statistical tests were 2-sided with a significance level of 0.05.||102.32|-106.34|0.9697
72557139|NCT03214588|144645332|SUPERIORITY||Least Squares Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.18|||TWO_SIDED|90.0|-0.3|0.4||||||Change at Week 7, SFT - TTA||0.4|-0.3|
72434357|NCT00708097|144381966|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|106.9||||0.044|TWO_SIDED|95.0|2.92|210.87||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment and period with subject as a random effect.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered population means of the treatments in comparison, to be equal with respect to EFU. Statistical tests were 2-sided with a significance level of 0.05.||210.87|2.92|0.0440
72434358|NCT00708097|144381966|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|160.92||||0.0026|TWO_SIDED|95.0|56.96|264.88||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment and period with subject as a random effect.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered population means of the treatments in comparison, to be equal with respect to EFU. Statistical tests were 2-sided with a significance level of 0.05.||264.88|56.96|0.0026
72557140|NCT03214588|144645332|SUPERIORITY||Least Squares Mean Difference|0.4|STANDARD_ERROR_OF_MEAN|0.15|||TWO_SIDED|90.0|0.2|0.7||||||Change at Week 7, SFT - TTA||0.7|0.2|
72557141|NCT03214588|144645332|SUPERIORITY||Least Squares Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.23|||TWO_SIDED|90.0|-0.5|0.2||||||Change at Week 12, SFT - TTA||0.2|-0.5|
72557142|NCT03214588|144645332|SUPERIORITY||Least Squares Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|0.19|||TWO_SIDED|90.0|0.0|0.7||||||Change at Week 12, SFT - TTA||0.7|0.0|
72557143|NCT03214588|144645332|SUPERIORITY||Least Squares Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.11|||TWO_SIDED|90.0|-0.2|0.1||||||Change at Week 2, SFT (Eyes Closed) - TTA||0.1|-0.2|
72557144|NCT03214588|144645332|SUPERIORITY||Least Squares Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.09|||TWO_SIDED|90.0|-0.2|0.1||||||Change at Week 2, SFT (Eyes Closed) - TTA||0.1|-0.2|
72557145|NCT03214588|144645332|SUPERIORITY||Least Squares Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.11|||TWO_SIDED|90.0|-0.2|0.2||||||Change at Week 7, SFT (Eyes Closed) - TTA||0.2|-0.2|
72557146|NCT03214588|144645332|SUPERIORITY||Least Squares Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.09|||TWO_SIDED|90.0|-0.1|0.2||||||Change at Week 7, SFT (Eyes Closed) - TTA||0.2|-0.1|
72557147|NCT03214588|144645332|SUPERIORITY||Least Squares Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.11|||TWO_SIDED|90.0|-0.2|0.2||||||Change at Week 12, SFT (Eyes Closed) - TTA||0.2|-0.2|
72557148|NCT03214588|144645332|SUPERIORITY||Least Squares Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.09|||TWO_SIDED|90.0|-0.3|0.0||||||Change at Week 12, SFT (Eyes Closed) - TTA||0.0|-0.3|
72557149|NCT03214588|144645332|SUPERIORITY||Least Squares Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.09|||TWO_SIDED|90.0|-0.2|0.1||||||Change at Week 2, Tandem Stance - TTA||0.1|-0.2|
72557150|NCT03214588|144645332|SUPERIORITY||Least Squares Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.07|||TWO_SIDED|90.0|-0.1|0.1||||||Change at Week 2, Tandem Stance - TTA||0.1|-0.1|
72557151|NCT03214588|144645332|SUPERIORITY||Least Squares Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.09|||TWO_SIDED|90.0|-0.2|0.0||||||Change at Week 7, Tandem Stance - TTA||0.0|-0.2|
72557152|NCT03214588|144645332|SUPERIORITY||Least Squares Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.07|||TWO_SIDED|90.0|-0.1|0.2||||||Change at Week 7, Tandem Stance - TTA||0.2|-0.1|
72557153|NCT03214588|144645332|SUPERIORITY||Least Squares Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.09|||TWO_SIDED|90.0|-0.2|0.1||||||Change at Week 12, Tandem Stance - TTA||0.1|-0.2|
72557154|NCT03214588|144645332|SUPERIORITY||Least Squares Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.07|||TWO_SIDED|90.0|-0.1|0.2||||||Change at Week 12, Tandem Stance - TTA||0.2|-0.1|
72557155|NCT03214588|144645332|SUPERIORITY||Least Squares Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.08|||TWO_SIDED|90.0|-0.1|0.1||||||Change at Week 2, Tandem Walk||0.1|-0.1|
72557156|NCT03214588|144645332|SUPERIORITY||Least Squares Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.07|||TWO_SIDED|90.0|-0.1|0.1||||||Change at Week 2, Tandem Walk||0.1|-0.1|
72557157|NCT03214588|144645332|SUPERIORITY||Least Squares Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.09|||TWO_SIDED|90.0|-0.2|0.1||||||Change at Week 7, Tandem Walk||0.1|-0.2|
72557158|NCT03214588|144645332|SUPERIORITY||Least Squares Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.07|||TWO_SIDED|90.0|-0.1|0.1||||||Change at Week 7, Tandem Walk||0.1|-0.1|
72557159|NCT03214588|144645332|SUPERIORITY||Least Squares Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.1|||TWO_SIDED|90.0|-0.3|0.0||||||Change at Week 12, Tandem Walk||0.0|-0.3|
72557160|NCT03214588|144645332|SUPERIORITY||Least Squares Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.08|||TWO_SIDED|90.0|-0.2|0.1||||||Change at Week 12, Tandem Walk||0.1|-0.2|
72557161|NCT03214588|144645332|SUPERIORITY||Least Squares Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.2|||TWO_SIDED|90.0|-0.2|0.4||||||Change at Week 2, Gait||0.4|-0.2|
72494012|NCT02321436|144517100|OTHER|Differences between treatment groups and p-values are based on an analysis of variance performed at each visit, taking into account treatment and spasticity status as fixed effects. Baseline value is value assessed at Visit 1.|Mean Difference (Final Values)|-0.84||||0.0027|TWO_SIDED|95.0|-1.36|-0.31||p value significance level = 5%|ANOVA|||Differences between treatment groups at Visit 5 (Week 10).||-0.31|-1.36|0.0027
72557162|NCT03214588|144645332|SUPERIORITY||Least Squares Mean Difference|0.4|STANDARD_ERROR_OF_MEAN|0.17|||TWO_SIDED|90.0|0.1|0.7||||||Change at Week 2, Gait||0.7|0.1|
72557163|NCT03214588|144645332|SUPERIORITY||Least Squares Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.17|||TWO_SIDED|90.0|-0.4|0.2||||||Change at Week 7, Gait||0.2|-0.4|
72557164|NCT03214588|144645332|SUPERIORITY||Least Squares Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|0.15|||TWO_SIDED|90.0|0.1|0.6||||||Change at Week 7, Gait||0.6|0.1|
72557165|NCT03214588|144645332|SUPERIORITY||Least Squares Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.17|||TWO_SIDED|90.0|-0.4|0.2||||||Change at Week 12, Gait||0.2|-0.4|
72557166|NCT03214588|144645332|SUPERIORITY||Least Squares Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|90.0|0.0|0.5||||||Change at Week 12, Gait||0.5|0.0|
72557167|NCT03214588|144645333|SUPERIORITY||Least Squares Mean Difference|0.23|STANDARD_ERROR_OF_MEAN|0.889||0.599|TWO_SIDED|90.0|-1.31|1.76||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA|||Change from Baseline at Week 2||1.76|-1.31|0.599
72557168|NCT03214588|144645333|SUPERIORITY||Least Squares Mean Difference|1.34|STANDARD_ERROR_OF_MEAN|0.625||0.978|TWO_SIDED|90.0|0.26|2.42||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA|||Change from Baseline at Week 2||2.42|0.26|0.978
72557169|NCT03214588|144645333|SUPERIORITY||Least Squares Mean Difference|0.09|STANDARD_ERROR_OF_MEAN|1.14||0.533|TWO_SIDED|90.0|-1.87|2.06||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA|||Change from Baseline at Week 7||2.06|-1.87|0.533
72557170|NCT03214588|144645333|SUPERIORITY||Least Squares Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.886||0.37|TWO_SIDED|90.0|-1.83|1.23||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA|||Change from Baseline at Week 7||1.23|-1.83|0.370
72557171|NCT03214588|144645333|SUPERIORITY||Least Squares Mean Difference|2.18|STANDARD_ERROR_OF_MEAN|1.078||0.972|TWO_SIDED|90.0|0.32|4.04||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA|||Change from Baseline at Week 12||4.04|0.32|0.972
72557172|NCT03214588|144645333|SUPERIORITY||Least Squares Mean Difference|0.78|STANDARD_ERROR_OF_MEAN|0.819||0.825|TWO_SIDED|90.0|-0.63|2.19||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA|||Change from Baseline at Week 12||2.19|-0.63|0.825
72557173|NCT03214588|144645334|SUPERIORITY||Least Squares Mean Difference|0.045|STANDARD_ERROR_OF_MEAN|0.23858||0.426|TWO_SIDED|90.0|-0.3665|0.4565||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA|||Change from Baseline at Week 2||0.4565|-0.3665|0.426
72557174|NCT03214588|144645334|SUPERIORITY||Least Squares Mean Difference|-0.3281|STANDARD_ERROR_OF_MEAN|0.15794||0.975|TWO_SIDED|90.0|-0.6005|-0.0557||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA|||Change from Baseline at Week 2||-0.0557|-0.6005|0.975
72557175|NCT03214588|144645334|SUPERIORITY||Least Squares Mean Difference|0.1448|STANDARD_ERROR_OF_MEAN|0.31186||0.324|TWO_SIDED|90.0|-0.3931|0.6826||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA|||Change from Baseline at Week 7||0.6826|-0.3931|0.324
72557176|NCT03214588|144645334|SUPERIORITY||Least Squares Mean Difference|0.0113|STANDARD_ERROR_OF_MEAN|0.23213||0.481|TWO_SIDED|90.0|-0.3891|0.4117||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA|||Change from Baseline at Week 7||0.4117|-0.3891|0.481
72557177|NCT03214588|144645334|SUPERIORITY||Least Squares Mean Difference|-0.2067|STANDARD_ERROR_OF_MEAN|0.28088||0.765|TWO_SIDED|90.0|-0.6911|0.2778||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA|||Change from Baseline at Week 12||0.2778|-0.6911|0.765
72557178|NCT03214588|144645334|SUPERIORITY||Least Squares Mean Difference|0.1173|STANDARD_ERROR_OF_MEAN|0.19778||0.28|TWO_SIDED|90.0|-0.2238|0.4585||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA|||Change from Baseline at Week 12||0.4585|-0.2238|0.280
72618657|NCT01026038|144768107|SUPERIORITY_OR_OTHER||GMC ratio|0.81|||||TWO_SIDED|95.0|0.3|2.21||||||Serotype 19F: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||2.21|0.30|
72557179|NCT03214588|144645335|SUPERIORITY||Least Squares Mean Difference|-2.7|STANDARD_ERROR_OF_MEAN|4.28||0.735|TWO_SIDED|90.0|-9.9|4.4||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA|||Change from Baseline at Week 2||4.4|-9.9|0.735
72557180|NCT03214588|144645335|SUPERIORITY||Least Squares Mean Difference|3.2|STANDARD_ERROR_OF_MEAN|3.51||0.182|TWO_SIDED|90.0|-2.7|9.1||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA|||Change from Baseline at Week 2||9.1|-2.7|0.182
72557181|NCT03214588|144645335|SUPERIORITY||Least Squares Mean Difference|-6.9|STANDARD_ERROR_OF_MEAN|3.59||0.97|TWO_SIDED|90.0|-12.9|-0.9||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA|||Change from Baseline at Week 7||-0.9|-12.9|0.970
72557182|NCT03214588|144645335|SUPERIORITY||Least Squares Mean Difference|1.4|STANDARD_ERROR_OF_MEAN|3.0||0.321|TWO_SIDED|90.0|-3.6|6.4||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA|||Change from Baseline at Week 7||6.4|-3.6|0.321
72557183|NCT03214588|144645335|SUPERIORITY||Least Squares Mean Difference|-5.8|STANDARD_ERROR_OF_MEAN|4.34||0.905|TWO_SIDED|90.0|-13.0|1.5||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA|||Change from Baseline at Week 12||1.5|-13.0|0.905
72557184|NCT03214588|144645335|SUPERIORITY||Least Squares Mean Difference|3.1|STANDARD_ERROR_OF_MEAN|3.57||0.199|TWO_SIDED|90.0|-2.9|9.0||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA|||Change from Baseline at Week 12||9.0|-2.9|0.199
72557185|NCT03214588|144645336|SUPERIORITY|||||||0.974||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 2||||0.974
72557186|NCT03214588|144645336|SUPERIORITY|||||||0.893||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 2||||0.893
72557187|NCT03214588|144645336|SUPERIORITY|||||||0.954||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 7||||0.954
72557188|NCT03214588|144645336|SUPERIORITY|||||||0.793||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 7||||0.793
72557189|NCT03214588|144645336|SUPERIORITY|||||||0.845||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 12||||0.845
72557190|NCT03214588|144645336|SUPERIORITY|||||||0.816||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 12||||0.816
72557191|NCT03214588|144645337|SUPERIORITY|||||||0.84||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 2||||0.840
72557192|NCT03214588|144645337|SUPERIORITY|||||||0.854||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 2||||0.854
72557193|NCT03214588|144645337|SUPERIORITY|||||||0.922||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 7||||0.922
72382020|NCT04131556|144272669|EQUIVALENCE|Equivalence analysis based on confidence intervals (CIs). If the 90% CIs of the geometric mean ratios were within (0.8, 1.25), bioequivalence between the two formulations (test powder for oral suspension versus reference tablet) was to be claimed. A linear mixed effect ANOVA model with treatment, period, sequence as fixed effects and participant within sequence as a random effect was used to fit to ln-transformed PK parameters.|% Ratio of Geometric least squares means|62.29|||||TWO_SIDED|90.0|54.73|70.9|||ANOVA|||||70.90|54.73|
72434359|NCT00708097|144381966|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|222.47|||<|0.0001|TWO_SIDED|95.0|117.58|327.36||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment and period with subject as a random effect.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered population means of the treatments in comparison, to be equal with respect to EFU. Statistical tests were 2-sided with a significance level of 0.05.||327.36|117.58|<0.0001
72557194|NCT03214588|144645337|SUPERIORITY|||||||0.794||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 7||||0.794
72557195|NCT03214588|144645337|SUPERIORITY|||||||0.83||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 12||||0.830
72557196|NCT03214588|144645337|SUPERIORITY|||||||0.998||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 12||||0.998
72557197|NCT03214588|144645338|SUPERIORITY|||||||0.987||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 2||||0.987
72557198|NCT03214588|144645338|SUPERIORITY|||||||0.771||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 2||||0.771
72557199|NCT03214588|144645338|SUPERIORITY|||||||0.526||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 7||||0.526
72557200|NCT03214588|144645338|SUPERIORITY|||||||0.665||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 7||||0.665
72557201|NCT03214588|144645338|SUPERIORITY|||||||0.576||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 12||||0.576
72557202|NCT03214588|144645338|SUPERIORITY|||||||0.865||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 12||||0.865
72557203|NCT03214588|144645339|SUPERIORITY|||||||0.966||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 2||||0.966
72557204|NCT03214588|144645339|SUPERIORITY|||||||0.983||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 2||||0.983
72557205|NCT03214588|144645339|SUPERIORITY|||||||0.953||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 7||||0.953
72557206|NCT03214588|144645339|SUPERIORITY|||||||0.781||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 7||||0.781
72557207|NCT03214588|144645339|SUPERIORITY|||||||0.948||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 12||||0.948
72557208|NCT03214588|144645339|SUPERIORITY|||||||0.998||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 12||||0.998
72557209|NCT03214588|144645340|SUPERIORITY|||||||0.666||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 2||||0.666
72557210|NCT03214588|144645340|SUPERIORITY|||||||0.812||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 2||||0.812
72557211|NCT03214588|144645340|SUPERIORITY|||||||0.834||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 7||||0.834
72557212|NCT03214588|144645340|SUPERIORITY|||||||0.841||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 7||||0.841
72557213|NCT03214588|144645340|SUPERIORITY|||||||0.893||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 12||||0.893
72557214|NCT03214588|144645340|SUPERIORITY|||||||0.907||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 12||||0.907
72557215|NCT03214588|144645341|SUPERIORITY|||||||0.032||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 2||||0.032
72557216|NCT03214588|144645341|SUPERIORITY|||||||0.216||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 2||||0.216
72557217|NCT03214588|144645341|SUPERIORITY|||||||0.215||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 7||||0.215
72557218|NCT03214588|144645341|SUPERIORITY|||||||0.411||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 7||||0.411
72618658|NCT01026038|144768107|SUPERIORITY_OR_OTHER||GMC ratio|0.9|||||TWO_SIDED|95.0|0.43|1.89||||||Serotype 23F: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||1.89|0.43|
72557219|NCT03214588|144645341|SUPERIORITY|||||||0.194||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 12||||0.194
72557220|NCT03214588|144645341|SUPERIORITY|||||||0.408||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 12||||0.408
72557221|NCT03214588|144645342|SUPERIORITY|||||||0.406||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 2||||0.406
72557222|NCT03214588|144645342|SUPERIORITY|||||||0.235||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 2||||0.235
72557223|NCT03214588|144645342|SUPERIORITY|||||||0.225||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 7||||0.225
72557224|NCT03214588|144645342|SUPERIORITY|||||||0.434||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 7||||0.434
72557225|NCT03214588|144645342|SUPERIORITY|||||||0.249||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 12||||0.249
72557226|NCT03214588|144645342|SUPERIORITY|||||||0.38||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 12||||0.380
72557227|NCT03214588|144645343|SUPERIORITY|||||||0.422||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 2||||0.422
72618659|NCT01026038|144768107|SUPERIORITY_OR_OTHER||GMC ratio|0.83|||||TWO_SIDED|95.0|0.42|1.67||||||Serotype 23F: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.67|0.42|
72557228|NCT03214588|144645343|SUPERIORITY|||||||0.226||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 2||||0.226
72557229|NCT03214588|144645343|SUPERIORITY|||||||0.639||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 7||||0.639
72557230|NCT03214588|144645343|SUPERIORITY|||||||0.094||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 7||||0.094
72557231|NCT03214588|144645343|SUPERIORITY|||||||0.516||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 12||||0.516
72557232|NCT03214588|144645343|SUPERIORITY|||||||0.266||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 12||||0.266
72557233|NCT03214588|144645344|SUPERIORITY||Least Squares Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.362||0.299|TWO_SIDED|90.0|-0.8|0.41||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA|||Change from Baseline at Week 2||0.41|-0.80|0.299
72557234|NCT03214588|144645344|SUPERIORITY||Least Squares Mean Difference|0.55|STANDARD_ERROR_OF_MEAN|0.293||0.967|TWO_SIDED|90.0|0.06|1.04||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA|||Change from Baseline at Week 2||1.04|0.06|0.967
72557235|NCT03214588|144645344|SUPERIORITY||Least Squares Mean Difference|0.02|STANDARD_ERROR_OF_MEAN|0.338||0.529|TWO_SIDED|90.0|-0.54|0.59||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA|||Change from Baseline at Week 7||0.59|-0.54|0.529
72382021|NCT04131556|144272670|OTHER||Median Difference (Final Values)|1.25|||<|0.001|TWO_SIDED|90.0|0.75|1.75|||Wilcoxon signed rank test|||Statistical analysis of tmax was performed using a nonparametric test. The median difference of tmax between treatments and 90% CIs of the median differences were calculated from Hodges-Lehman estimate, and p-value was produced from Wilcoxon signed rank test.||1.75|0.75|<.001
72382022|NCT04131556|144272670|OTHER||Median Difference (Final Values)|1.0|||<|0.001|TWO_SIDED|90.0|0.75|1.25|||Wilcoxon signed rank test|||Statistical analysis of tmax was performed using a nonparametric test. The median difference of tmax between treatments and 90% CIs of the median differences were calculated from Hodges-Lehman estimate, and p-value was produced from Wilcoxon signed rank test.||1.25|0.75|<.001
72382023|NCT04131556|144272671|EQUIVALENCE|Equivalence analysis based on confidence intervals (CIs). If the 90% CIs of the geometric mean ratios were within (0.8, 1.25), bioequivalence between the two formulations (test powder for oral suspension versus reference tablet) was to be claimed. A linear mixed effect ANOVA model with treatment, period, sequence as fixed effects and participant within sequence as a random effect was used to fit to ln-transformed PK parameters.|% Ratio of Geometric least squares means|81.27|||||TWO_SIDED|90.0|73.88|89.4|||ANOVA|||||89.40|73.88|
72382024|NCT04131556|144272671|EQUIVALENCE|Equivalence analysis based on confidence intervals (CIs). If the 90% CIs of the geometric mean ratios were within (0.8, 1.25), bioequivalence between the two formulations (test powder for oral suspension versus reference tablet) was to be claimed. A linear mixed effect ANOVA model with treatment, period, sequence as fixed effects and participant within sequence as a random effect was used to fit to ln-transformed PK parameters.|% Ratio of Geometric least squares means|78.0|||||TWO_SIDED|90.0|70.92|85.79|||ANOVA|||||85.79|70.92|
72382025|NCT04131556|144272672|EQUIVALENCE|Equivalence analysis based on confidence intervals (CIs). If the 90% CIs of the geometric mean ratios were within (0.8, 1.25), bioequivalence between the two formulations (test powder for oral suspension versus reference tablet) was to be claimed. A linear mixed effect ANOVA model with treatment, period, sequence as fixed effects and participant within sequence as a random effect was used to fit to ln-transformed PK parameters.|% Ratio of Geometric least squares means|83.52|||||TWO_SIDED|90.0|76.12|91.64|||ANOVA|||||91.64|76.12|
72382026|NCT04131556|144272672|EQUIVALENCE|Equivalence analysis based on confidence intervals (CIs). If the 90% CIs of the geometric mean ratios were within (0.8, 1.25), bioequivalence between the two formulations (test powder for oral suspension versus reference tablet) was to be claimed. A linear mixed effect ANOVA model with treatment, period, sequence as fixed effects and participant within sequence as a random effect was used to fit to ln-transformed PK parameters.|% Ratio of Geometric least squares means|80.36|||||TWO_SIDED|90.0|73.26|88.16|||ANOVA|||||88.16|73.26|
72382027|NCT04131556|144272675|OTHER||Median Difference (Final Values)|0.13||||0.006|TWO_SIDED|90.0|0.13|0.25|||Wilcoxon signed rank test|||Statistical analysis of Tlag was performed using a nonparametric test. The median difference of Tlag between treatments and 90% CIs of the median differences were calculated from Hodges-Lehman estimate, and p-value was produced from Wilcoxon signed rank test.||0.25|0.13|0.006
72382028|NCT04131556|144272675|OTHER||Median Difference (Final Values)|0.13||||0.011|TWO_SIDED|90.0|0.13|0.25|||Wilcoxon signed rank test|||Statistical analysis of Tlag was performed using a nonparametric test. The median difference of Tlag between treatments and 90% CIs of the median differences were calculated from Hodges-Lehman estimate, and p-value was produced from Wilcoxon signed rank test.||0.25|0.13|0.011
72382029|NCT00760214|144272696|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.41|||<|0.001|TWO_SIDED|95.0|-11.04|-5.78||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value presented. Overall 0.05 level of significance for multiple comparisons controlled using stepwise testing procedure.|ANCOVA|||||-5.78|-11.04|<.001
72557236|NCT03214588|144645344|SUPERIORITY||Least Squares Mean Difference|0.33|STANDARD_ERROR_OF_MEAN|0.279||0.88|TWO_SIDED|90.0|-0.13|0.8||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA|||Change from Baseline at Week 7||0.80|-0.13|0.880
72557237|NCT03214588|144645344|SUPERIORITY||Least Squares Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.408||0.599|TWO_SIDED|90.0|-0.58|0.79||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA|||Change from Baseline at Week 12||0.79|-0.58|0.599
72557238|NCT03214588|144645344|SUPERIORITY||Least Squares Mean Difference|0.34|STANDARD_ERROR_OF_MEAN|0.333||0.846|TWO_SIDED|90.0|-0.21|0.9||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA|||Change from Baseline at Week 12||0.90|-0.21|0.846
72557239|NCT03214588|144645345|SUPERIORITY||Odds Ratio (OR)|0.0|||>|0.999||||||P-value was from Fisher's exact test. Odds ratio was obtained from Cochran-Mantel-Haenszel with ambulation status at randomization as a stratification factor.|Fisher Exact|||At Least 15% Reduction from Baseline||||>0.999
72618660|NCT01026038|144768107|SUPERIORITY_OR_OTHER||GMC ratio|0.93|||||TWO_SIDED|95.0|0.4|2.16||||||Serotype 23F: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||2.16|0.40|
72557240|NCT03214588|144645345|SUPERIORITY||Odds Ratio (OR)|0.0|||>|0.999||||||P-value was from Fisher's exact test. Odds ratio was obtained from Cochran-Mantel-Haenszel with ambulation status at randomization as a stratification factor.|Fisher Exact|||At Least 15% Reduction from Baseline||||>0.999
72557241|NCT03214588|144645345|SUPERIORITY||Odds Ratio (OR)|0.0|||>|0.999||||||P-value was from Fisher's exact test. Odds ratio was obtained from Cochran-Mantel-Haenszel with ambulation status at randomization as a stratification factor.|Fisher Exact|||At Least 20% Reduction from Baseline||||>0.999
72557242|NCT03214588|144645345|SUPERIORITY||Odds Ratio (OR)|0.0|||>|0.999||||||P-value was from Fisher's exact test. Odds ratio was obtained from Cochran-Mantel-Haenszel with ambulation status at randomization as a stratification factor.|Fisher Exact|||At Least 20% Reduction from Baseline||||>0.999
72557243|NCT03480763|144645363|OTHER|Estimated differences, confidence intervals (CIs), and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percent|4.2||||0.043|TWO_SIDED|95.0|0.1|8.5|||Miettinen & Nurminen|||Injection site redness/erythema||8.5|0.1|0.043
72618661|NCT01026038|144768107|SUPERIORITY_OR_OTHER||GMC ratio|7.53|||||TWO_SIDED|95.0|2.86|19.78||||||Serotype 1: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||19.78|2.86|
72434360|NCT00708097|144381966|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|108.91||||0.0382|TWO_SIDED|95.0|5.98|211.83||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment and period with subject as a random effect.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered population means of the treatments in comparison, to be equal with respect to EFU. Statistical tests were 2-sided with a significance level of 0.05.||211.83|5.98|0.0382
72434361|NCT00708097|144381966|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|162.93||||0.0021|TWO_SIDED|95.0|59.68|266.18||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment and period with subject as a random effect.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered population means of the treatments in comparison, to be equal with respect to EFU. Statistical tests were 2-sided with a significance level of 0.05.||266.18|59.68|0.0021
72434362|NCT00708097|144381966|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|224.48|||<|0.0001|TWO_SIDED|95.0|120.51|328.46||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment and period with subject as a random effect.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered population means of the treatments in comparison, to be equal with respect to EFU. Statistical tests were 2-sided with a significance level of 0.05.||328.46|120.51|<0.0001
72434363|NCT00708097|144381966|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|54.03||||0.3003|TWO_SIDED|95.0|-48.56|156.61||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment and period with subject as a random effect.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered population means of the treatments in comparison, to be equal with respect to EFU. Statistical tests were 2-sided with a significance level of 0.05.||156.61|-48.56|0.3003
72434364|NCT00708097|144381966|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|61.55||||0.2432|TWO_SIDED|95.0|-42.14|165.24||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment and period with subject as a random effect.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered population means of the treatments in comparison, to be equal with respect to EFU. Statistical tests were 2-sided with a significance level of 0.05.||165.24|-42.14|0.2432
72434365|NCT00708097|144381966|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|115.58||||0.0289|TWO_SIDED|95.0|12.02|219.13||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment and period with subject as a random effect.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered population means of the treatments in comparison, to be equal with respect to EFU. Statistical tests were 2-sided with a significance level of 0.05.||219.13|12.02|0.0289
72434366|NCT00708097|144381967|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-13.9||||0.9293|TWO_SIDED|95.0|-322.47|294.66||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment and period with subject as a random effect.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered population means of the treatments in comparison, to be equal with respect to EFU. Statistical tests were 2-sided with a significance level of 0.05.||294.66|-322.47|0.9293
72434367|NCT00708097|144381967|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|575.71||||0.0003|TWO_SIDED|95.0|268.24|883.17||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment and period with subject as a random effect.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered population means of the treatments in comparison, to be equal with respect to EFU. Statistical tests were 2-sided with a significance level of 0.05.||883.17|268.24|0.0003
72434368|NCT00708097|144381967|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|637.67|||<|0.0001|TWO_SIDED|95.0|330.3|945.03||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment and period with subject as a random effect.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered population means of the treatments in comparison, to be equal with respect to EFU. Statistical tests were 2-sided with a significance level of 0.05.||945.03|330.30|<0.0001
72434369|NCT00708097|144381967|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|1813.29|||<|0.0001|TWO_SIDED|95.0|1503.03|2123.54||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment and period with subject as a random effect.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered population means of the treatments in comparison, to be equal with respect to EFU. Statistical tests were 2-sided with a significance level of 0.05.||2123.54|1503.03|<0.0001
72434370|NCT00708097|144381967|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|589.61||||0.0002|TWO_SIDED|95.0|285.31|893.92|||ANOVA|ANOVA with factors for treatment and period with subject as a random effect.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered population means of the treatments in comparison, to be equal with respect to EFU. Statistical tests were 2-sided with a significance level of 0.05.||893.92|285.31|0.0002
72434371|NCT00708097|144381967|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|651.57|||<|0.0001|TWO_SIDED|95.0|346.44|956.7||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment and period with subject as a random effect.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered population means of the treatments in comparison, to be equal with respect to EFU. Statistical tests were 2-sided with a significance level of 0.05.||956.70|346.44|<0.0001
72382030|NCT00760214|144272696|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.03|||<|0.001|TWO_SIDED|95.0|-11.66|-6.39||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value presented. Overall 0.05 level of significance for multiple comparisons controlled using stepwise testing procedure.|ANCOVA|||||-6.39|-11.66|<.001
72382031|NCT00760214|144272697|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.31|||<|0.001|TWO_SIDED|95.0|-6.85|-3.78||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value presented.|ANCOVA|||||-3.78|-6.85|<.001
72382032|NCT00760214|144272697|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.66|||<|0.001|TWO_SIDED|95.0|-7.21|-4.12||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value presented.|ANCOVA|||||-4.12|-7.21|<.001
72382033|NCT00760214|144272698|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.82|||<|0.001|TWO_SIDED|95.0|-7.64|-2.01||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value presented.|ANCOVA|||||-2.01|-7.64|<.001
72382034|NCT00760214|144272698|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.47||||0.002|TWO_SIDED|95.0|-7.27|-1.66||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value presented.|ANCOVA|||||-1.66|-7.27|0.002
72382035|NCT00760214|144272699|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.77||||0.003|TWO_SIDED|95.0|-4.61|-0.94||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value presented.|ANCOVA|||||-0.94|-4.61|0.003
72382036|NCT00760214|144272699|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.06||||0.001|TWO_SIDED|95.0|-4.89|-1.24||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value presented.|ANCOVA|||||-1.24|-4.89|0.001
72382037|NCT00760214|144272700|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.77||||0.017|TWO_SIDED|95.0|-6.87|-0.68||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value presented.|ANCOVA|||||-0.68|-6.87|0.017
72382038|NCT00760214|144272700|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.43||||0.029|TWO_SIDED|95.0|-6.5|-0.36||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value presented.|ANCOVA|||||-0.36|-6.50|0.029
72382039|NCT00760214|144272701|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.06||||0.052|TWO_SIDED|95.0|-4.15|0.02||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value presented.|ANCOVA|||||0.02|-4.15|0.052
72382040|NCT00760214|144272701|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.42||||0.022|TWO_SIDED|95.0|-4.49|-0.35||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value presented.|ANCOVA|||||-0.35|-4.49|0.022
72382041|NCT00760214|144272702|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.53||||0.003|TWO_SIDED|95.0|-7.46|-1.59||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value presented.|ANCOVA|||||-1.59|-7.46|0.003
72382042|NCT00760214|144272702|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.26||||0.004|TWO_SIDED|95.0|-7.18|-1.35||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value presented.|ANCOVA|||||-1.35|-7.18|0.004
72382043|NCT00760214|144272703|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.64||||0.008|TWO_SIDED|95.0|-4.6|-0.68||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value presented.|ANCOVA|||||-0.68|-4.60|0.008
72382044|NCT00760214|144272703|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.98||||0.003|TWO_SIDED|95.0|-4.93|-1.04||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value presented.|ANCOVA|||||-1.04|-4.93|0.003
72434372|NCT00708097|144381967|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|1827.19|||<|0.0001|TWO_SIDED|95.0|1519.78|2134.6||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment and period with subject as a random effect.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered population means of the treatments in comparison, to be equal with respect to EFU. Statistical tests were 2-sided with a significance level of 0.05.||2134.60|1519.78|<0.0001
72557244|NCT03480763|144645363|OTHER|Estimated differences, CIs, and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percent|13.7|||<|0.001|TWO_SIDED|95.0|6.0|21.2|||Miettinen & Nurminen|||Injection site tenderness/pain||21.2|6.0|<0.001
72382045|NCT00760214|144272704|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.95|||<|0.001|TWO_SIDED|95.0|-9.12|-2.77||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value presented.|ANCOVA|||||-2.77|-9.12|<.001
72382046|NCT00760214|144272704|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.82|||<|0.001|TWO_SIDED|95.0|-8.96|-2.67||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value presented.|ANCOVA|||||-2.67|-8.96|<.001
72382047|NCT00760214|144272705|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.01||||0.006|TWO_SIDED|95.0|-5.15|-0.88||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value presented.|ANCOVA|||||-0.88|-5.15|0.006
72382048|NCT00760214|144272705|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.77|||<|0.001|TWO_SIDED|95.0|-5.89|-1.65||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value presented.|ANCOVA|||||-1.65|-5.89|<.001
72382049|NCT00760214|144272706|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.87|||<|0.001|TWO_SIDED|95.0|-12.15|-5.6||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value presented.|ANCOVA|||||-5.60|-12.15|<.001
72382050|NCT00760214|144272706|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.2|||<|0.001|TWO_SIDED|95.0|-11.46|-4.95||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value presented.|ANCOVA|||||-4.95|-11.46|<.001
72434373|NCT00708097|144381967|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|61.96||||0.6874|TWO_SIDED|95.0|-241.25|365.17||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment and period with subject as a random effect.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered population means of the treatments in comparison, to be equal with respect to EFU. Statistical tests were 2-sided with a significance level of 0.05.||365.17|-241.25|0.6874
72382051|NCT00760214|144272707|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.68|||<|0.001|TWO_SIDED|95.0|-8.19|-3.17||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value presented.|ANCOVA|||||-3.17|-8.19|<.001
72382052|NCT00760214|144272707|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.32|||<|0.001|TWO_SIDED|95.0|-7.81|-2.82||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value presented.|ANCOVA|||||-2.82|-7.81|<.001
72382053|NCT02545075|144272720|SUPERIORITY|||||||0.5059|||||||Chi-squared|One-sided p-value based on unstratified chi-square test||||||0.5059
72382054|NCT02545075|144272721|SUPERIORITY|||||||0.6202|||||||Chi-squared|One-sided unstratified chi-square||||||0.6202
72382055|NCT02545075|144272722|SUPERIORITY||Stratified cox proportional hazard model|1.13||||0.7267|TWO_SIDED|80.0|0.87|1.45|||Log Rank|One-sided p-value from Log-rank Test stratified by M substage (M1a+M1b vs. M1c)||||1.45|0.87|0.7267
72382056|NCT02545075|144272723|SUPERIORITY||Stratified Cox proportional hazard|0.9||||0.2503|TWO_SIDED|80.0|0.71|1.15|||Log Rank|One-sided p-value from Log-rank Test stratified by M substage (M1a+M1b vs. M1c) and BRAF mutation status as entered into the IVRS||||1.15|0.71|0.2503
72382057|NCT02545075|144272724|SUPERIORITY||Odds Ratio (OR)|1.0||||0.9932|TWO_SIDED|80.0|0.64|1.55|||Cochran-Mantel-Haenszel|||||1.55|0.64|0.9932
72382058|NCT02545075|144272725|SUPERIORITY||Odds Ratio (OR)|0.98||||0.9738|TWO_SIDED|80.0|0.48|2.03|||Cochran-Mantel-Haenszel|||||2.03|0.48|0.9738
72382059|NCT00736879|144272728|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.69|STANDARD_ERROR_OF_MEAN|0.1672|<|0.0001|TWO_SIDED|95.0|-1.02|-0.37||Tested at alpha=0.019 applying Dunnett's adjustment|ANCOVA|||||-0.37|-1.02|<0.0001
72382060|NCT00736879|144272728|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.74|STANDARD_ERROR_OF_MEAN|0.1679|<|0.0001|TWO_SIDED|95.0|-1.07|-0.41|||ANCOVA|Tested at alpha=0.019 applying Dunnett's adjustment.||||-0.41|-1.07|<0.0001
72382061|NCT00736879|144272728|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.84|STANDARD_ERROR_OF_MEAN|0.171|<|0.0001|TWO_SIDED|95.0|-1.17|-0.5|||ANCOVA|Tested at alpha=0.019 applying Dunnett's adjustment.||||-0.50|-1.17|<0.0001
72382062|NCT00736879|144272729|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.73|STANDARD_ERROR_OF_MEAN|0.5481||0.0018|TWO_SIDED|95.0|-2.81|-0.65||Test was performed at alpha=0.05.|ANCOVA|||By applying sequential testing procedure, the testing was performed since the primary endpoint was significant.||-0.65|-2.81|0.0018
72382063|NCT00736879|144272729|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.68|STANDARD_ERROR_OF_MEAN|0.5474||0.0024|TWO_SIDED|95.0|-2.76|-0.6||Test was performed at alpha=0.05.|ANCOVA|||||-0.60|-2.76|0.0024
72382064|NCT00736879|144272729|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.73|STANDARD_ERROR_OF_MEAN|0.5598||0.0022|TWO_SIDED|95.0|-2.83|-0.63||Test was performed at alpha=0.05.|ANCOVA|||||-0.63|-2.83|0.0022
72434374|NCT00708097|144381967|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|1237.58|||<|0.0001|TWO_SIDED|95.0|931.46|1543.7|||ANOVA|ANOVA with factors for treatment and period with subject as a random effect.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered population means of the treatments in comparison, to be equal with respect to EFU. Statistical tests were 2-sided with a significance level of 0.05.||1543.70|931.46|<0.0001
72382065|NCT00736879|144272730|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.1|STANDARD_ERROR_OF_MEAN|5.859||0.0103|TWO_SIDED|95.0|-26.7|-3.6||Test was performed at alpha=0.05.|ANCOVA|||||-3.6|-26.7|0.0103
72382066|NCT00736879|144272730|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-25.7|STANDARD_ERROR_OF_MEAN|5.816|<|0.0001|TWO_SIDED|95.0|-37.2|-14.3||Test was performed at alpha=0.05.|ANCOVA|||||-14.3|-37.2|<0.0001
72382067|NCT00736879|144272730|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-32.6|STANDARD_ERROR_OF_MEAN|5.962|<|0.0001|TWO_SIDED|95.0|-44.3|-20.8||Test was performed at alpha=0.05.|ANCOVA|||||-20.8|-44.3|<0.0001
72618662|NCT01026038|144768107|SUPERIORITY_OR_OTHER||GMC ratio|0.53|||||TWO_SIDED|95.0|0.22|1.31||||||Serotype 1: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.31|0.22|
72382068|NCT00736879|144272731|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-42.1|STANDARD_ERROR_OF_MEAN|8.8681|<|0.0001|TWO_SIDED|95.0|-59.56|-24.61||Test was performed at alpha=0.05.|ANCOVA|||||-24.61|-59.56|<0.0001
72382069|NCT00736879|144272731|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-48.1|STANDARD_ERROR_OF_MEAN|9.1963|<|0.0001|TWO_SIDED|95.0|-66.27|-30.03||Test was performed at alpha=0.05.|ANCOVA|||||-30.03|-66.27|<0.0001
72382070|NCT00736879|144272731|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-60.6|STANDARD_ERROR_OF_MEAN|9.1796|<|0.0001|TWO_SIDED|95.0|-78.67|-42.5||Test was performed at alpha=0.05.|ANCOVA|||||-42.50|-78.67|<0.0001
72382071|NCT00736879|144272732|SUPERIORITY_OR_OTHER||percent difference|18.9|STANDARD_ERROR_OF_MEAN|7.38||0.0157|TWO_SIDED|95.0|3.6|34.3||Test was performed at alpha=0.05.|Regression, Logistic|Logistic regression based on the methodology of Zhang, Tsiatis and Davidian and Tsiatis, Davidian, Zhang and Lu, with adjustment for baseline HbA1c.||The probability of response was modeled using a logistic regression model with baseline HbA1c as the covariate. Treatment group estimates of response rate were then obtained by integrating each group's modeled probability of response over the observed distribution of baseline covariate (combined across groups).||34.3|3.6|0.0157
72382072|NCT00736879|144272732|SUPERIORITY_OR_OTHER||Percent Difference|8.8|STANDARD_ERROR_OF_MEAN|7.65||0.2512|TWO_SIDED|95.0|-6.2|23.8||Test was performed at alpha=0.05.|Regression, Logistic|Logistic regression based on the methodology of Zhang, Tsiatis and Davidian and Tsiatis, Davidian, Zhang and Lu, with adjustment for baseline HbA1c||The probability of response was modeled using a logistic regression model with baseline HbA1c as the covariate. Treatment group estimates of response rate were then obtained by integrating each group's modeled probability of response over the observed distribution of baseline covariate (combined across groups).||23.8|-6.2|0.2512
72557245|NCT03480763|144645363|OTHER|Estimated differences, CIs, and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percent|4.8||||0.077|TWO_SIDED|95.0|-0.5|10.2|||Miettinen & Nurminen|||Injection site swelling||10.2|-0.5|0.077
72557246|NCT03480763|144645364|OTHER|Estimated differences, CIs, and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percent|0.6||||0.855|TWO_SIDED|95.0|-5.5|6.6|||Miettinen & Nurminen|||Injection site redness/erythema||6.6|-5.5|0.855
72557247|NCT03480763|144645364|OTHER|Estimated differences, CIs, and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percent|3.5||||0.385||95.0|-4.4|11.3|||Miettinen & Nurminen|||Injection site tenderness/pain||11.3|-4.4|0.385
72382073|NCT00736879|144272732|SUPERIORITY_OR_OTHER||Percent Difference|14.5|STANDARD_ERROR_OF_MEAN|8.069||0.0726|TWO_SIDED|95.0|-1.3|30.3||Test was performed at alpha=0.05.|Regression, Logistic|Logistic regression based on the methodology of Zhang, Tsiatis and Davidian and Tsiatis, Davidian, Zhang and Lu, with adjustment for baseline HbA1c||The probability of response was modeled using a logistic regression model with baseline HbA1c as the covariate. Treatment group estimates of response rate were then obtained by integrating each group's modeled probability of response over the observed distribution of baseline covariate (combined across groups).||30.3|-1.3|0.0726
72382074|NCT00736879|144272733|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8|STANDARD_ERROR_OF_MEAN|0.7954||0.3163|TWO_SIDED|95.0|-2.37|0.77||Test was performed at alpha=0.05.|ANCOVA|||||0.77|-2.37|0.3163
72382075|NCT00736879|144272733|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.61|STANDARD_ERROR_OF_MEAN|0.8154|||TWO_SIDED|95.0|-2.22|0.99|||ANCOVA|||Following a sequential testing procedure, this comparison was not statistically tested, ie, the previous comparison did not meet the criterion for statistical significance.||0.99|-2.22|
72382076|NCT00736879|144272733|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.47|STANDARD_ERROR_OF_MEAN|0.8238|||TWO_SIDED|95.0|-3.09|0.16|||ANCOVA|||Following a sequential testing procedure, this comparison was not statistically tested, ie, the previous comparison did not meet the criterion for statistical significance.||0.16|-3.09|
72382077|NCT02325791|144272866|SUPERIORITY||percentage treatment difference|1.15||||0.5773|TWO_SIDED|95.0|-2.898|5.201|||Cochran-Mantel-Haenszel|||A hierarchical inferential approach was used to control Type-1 error at 0.05 for pairwise comparisons of each suptavumab dose regimen to placebo. Missing values were imputed to KM estimate from the placebo group. Randomization strata adjusted in CMH test include region (North America vs. Rest of World) \& gestational age category (\<= 31 weeks 6 days GA vs \>= 32 weeks 0 days and \<= 35 weeks 6 days GA). Threshold for significance at 0.05 level.||5.201|-2.898|0.5773
72382078|NCT02325791|144272866|SUPERIORITY||percentage treatment difference|-0.44|||||TWO_SIDED|95.0|-4.318|3.438||Analysis performed using CMH statistics with randomization stratum adjusted using Mantel-Haenzel (MH) method to assess pairwise treatment difference (i.e. absolute risk reduction of each suptavumab arm compared to placebo.|Cochran-Mantel-Haenszel|||A hierarchical inferential approach was used to control Type-1 error at 0.05 for pairwise comparisons of each Suptavumab dose regimen to placebo. Missing values were imputed to Kaplan-Meier (KM) estimate from the placebo group. Randomization strata adjusted in Cochran-Mantel-Haenszel (CMH) test include region (North America vs. Rest of World) \& gestational age category (\<= 31 weeks 6 days GA vs \>= 32 weeks 0 days and \<= 35 weeks 6 days GA). Threshold for significance at 0.05 level.||3.438|-4.318|
72382079|NCT02325791|144272870|SUPERIORITY||percentage treatment difference|-0.67|||||TWO_SIDED|95.0|-5.291|3.959|||Cochran-Mantel-Haenszel|||A hierarchical inferential approach was used to control Type-1 error at 0.05 for pairwise comparisons of each suptavumab dose regimen to placebo. Missing values were imputed to KM estimate from the placebo group. Randomization strata adjusted in CMH test include region (North America vs. Rest of World) \& gestational age category (\<= 31 weeks 6 days GA vs \>= 32 weeks 0 days and \<= 35 weeks 6 days GA). Threshold for significance at 0.05 level.||3.959|-5.291|
72382080|NCT02325791|144272870|SUPERIORITY||percentage treatment difference|2.02|||||TWO_SIDED|95.0|-2.836|6.867|||Cochran-Mantel-Haenszel|||A hierarchical inferential approach was used to control Type-1 error at 0.05 for pairwise comparisons of each suptavumab dose regimen to placebo. Missing values were imputed to KM estimate from the placebo group. Randomization strata adjusted in CMH test include region (North America vs. Rest of World) \& gestational age category (\<= 31 weeks 6 days GA vs \>= 32 weeks 0 days and \<= 35 weeks 6 days GA). Threshold for significance at 0.05 level.||6.867|-2.836|
72382081|NCT04795622|144272923|SUPERIORITY||Odds Ratio (OR)|1.3545|||||TWO_SIDED|95.0|0.753|2.4365||||||||2.4365|0.7530|
72382082|NCT04795622|144272924|SUPERIORITY||Point Estimate|-0.0856|||||TWO_SIDED|95.0|-0.2395|0.0683||||||X-axis||0.0683|-0.2395|
72382083|NCT04795622|144272924|SUPERIORITY||Point Estimate|-0.033|||||TWO_SIDED|95.0|-0.2268|0.1608||||||Y-axis||0.1608|-0.2268|
72382084|NCT04795622|144272924|SUPERIORITY||Point Estimate|0.1791|||||TWO_SIDED|95.0|-0.1551|0.5133||||||Z-axis||0.5133|-0.1551|
72382085|NCT02398409|144272929|SUPERIORITY||Mean Difference (Net)|0.016|STANDARD_ERROR_OF_MEAN|0.117||0.8407|TWO_SIDED|||||Adjusting for the covariates of diagnosis and baseline mean value in caregivers' depression.|Mixed Models Analysis|||12 weeks compared to Baseline (BL)||||.8407
72382086|NCT02398409|144272929|SUPERIORITY||Median Difference (Net)|0.201|STANDARD_ERROR_OF_MEAN|0.12||0.015|TWO_SIDED|||||Adjusting for the covariates of diagnosis and baseline mean value in caregivers' depression.|Mixed Models Analysis|||At 6 months compared to BL||||.0150
72557248|NCT03480763|144645364|OTHER|Estimated differences, CIs, and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percent|2.0||||0.577|TWO_SIDED|95.0|-5.1|9.2|||Miettinen & Nurminen|||Injection site swelling||9.2|-5.1|0.577
72557249|NCT03480763|144645365|OTHER|Estimated differences, CIs, and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percent|1.2||||0.523|TWO_SIDED|95.0|-2.5|4.9|||Miettinen & Nurminen|||Joint pain/arthralgia||4.9|-2.5|0.523
72618663|NCT01026038|144768107|SUPERIORITY_OR_OTHER||GMC ratio|0.07|||||TWO_SIDED|95.0|0.02|0.21||||||Serotype 1: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||0.21|0.02|
72382087|NCT02398409|144272929|SUPERIORITY||Median Difference (Net)|0.114|STANDARD_ERROR_OF_MEAN|0.188||0.8373|TWO_SIDED|||||adjusting for the covariates of diagnosis and baseline mean value in caregivers' depression|Mixed Models Analysis|||1 year compared BL||||.8373
72382088|NCT02398409|144272930|SUPERIORITY||Median Difference (Net)|0.016|STANDARD_ERROR_OF_MEAN|0.173||0.6445|TWO_SIDED|||||adjusting for the covariates of diagnosis and baseline mean value in caregivers' depression|Mixed Models Analysis|||12 weeks compared to BL||||.6445
72382089|NCT02398409|144272930|SUPERIORITY||Median Difference (Net)|0.033|STANDARD_ERROR_OF_MEAN|0.158||0.5247|TWO_SIDED|||||adjusting for the covariates of diagnosis and baseline mean value in caregivers' depression|Mixed Models Analysis|||6 months compared to BL||||.5247
72494013|NCT02321436|144517100|OTHER|Differences between treatment groups and p-values are based on an analysis of variance performed at each visit, taking into account treatment and spasticity status as fixed effects. Baseline value is value assessed at Visit 1.|Mean Difference (Final Values)|-0.83||||0.0052|TWO_SIDED|95.0|-1.39|-0.26||p value significance level = 5%|ANOVA|||Differences between treatment groups at Visit 6 (Week 12).||-0.26|-1.39|0.0052
72494014|NCT02321436|144517100|OTHER|Differences between treatment groups and p-values are based on an analysis of variance performed at each visit, taking into account treatment and spasticity status as fixed effects. Baseline value is value assessed at Visit 1.|Mean Difference (Final Values)|-0.52||||0.2037|TWO_SIDED|95.0|-1.35|0.31||p value significance level = 5%|ANOVA|||Differences between treatment groups at Visit 7 (Week 16).||0.31|-1.35|0.2037
72494015|NCT02321436|144517100|OTHER|Differences between treatment groups and p-values are based on an analysis of variance performed at each visit, taking into account treatment and spasticity status as fixed effects. Baseline value is value assessed at Visit 1.|Mean Difference (Final Values)|-0.15||||0.7656|TWO_SIDED|95.0|-1.25|0.94||p value significance level = 5%|ANOVA|||Differences between treatment groups at Visit 8 (Week 20).||0.94|-1.25|0.7656
72494016|NCT02321436|144517100|OTHER|Differences between treatment groups and p-values are based on an analysis of variance performed at each visit, taking into account treatment and spasticity status as fixed effects. Baseline value is value assessed at Visit 1.|Mean Difference (Final Values)|-0.12||||0.8521|TWO_SIDED|95.0|-1.46|1.23||p value significance level = 5%|ANOVA|||Differences between treatment groups at Visit 9 (Week 24).||1.23|-1.46|0.8521
72494017|NCT02321436|144517100|OTHER|Differences between treatment groups and p-values are based on an analysis of variance performed at each visit, taking into account treatment and spasticity status as fixed effects. Baseline value is value assessed at Visit 1.|Mean Difference (Final Values)|-0.21||||0.6582|TWO_SIDED|95.0|-1.24|0.81||p value significance level = 5%|ANOVA|||Differences between treatment groups at Visit 10 (Week 28).||0.81|-1.24|0.6582
72494018|NCT02321436|144517101|OTHER|Differences between treatment groups and p-values are based on an analysis of variance performed at each visit, taking into account treatment and spasticity status as fixed effects. Baseline value is value assessed at Visit 1.|Mean Difference (Final Values)|0.8||||0.8754|TWO_SIDED|95.0|-9.5|11.1||p value significance level = 5%|ANOVA|||Differences between treatment groups at Visit 2 (Week 4).||11.1|-9.5|0.8754
72494019|NCT02321436|144517101|OTHER|Differences between treatment groups and p-values are based on an analysis of variance performed at each visit, taking into account treatment and spasticity status as fixed effects. Baseline value is value assessed at Visit 1.|Mean Difference (Final Values)|-0.9||||0.8805|TWO_SIDED|95.0|-12.8|11.1||p value significance level = 5%|ANOVA|||Differences between treatment groups at Visit 3 (Week 6).||11.1|-12.8|0.8805
72494020|NCT02321436|144517101|OTHER|Differences between treatment groups and p-values are based on an analysis of variance performed at each visit, taking into account treatment and spasticity status as fixed effects. Baseline value is value assessed at Visit 1.|Mean Difference (Final Values)|-2.2||||0.6992|TWO_SIDED|95.0|-14.0|9.6||p value significance level = 5%|ANOVA|||Differences between treatment groups at Visit 4 (Week 8).||9.6|-14.0|0.6992
72494021|NCT02321436|144517101|OTHER|Differences between treatment groups and p-values are based on an analysis of variance performed at each visit, taking into account treatment and spasticity status as fixed effects. Baseline value is value assessed at Visit 1.|Mean Difference (Final Values)|-0.1||||0.9882|TWO_SIDED|95.0|-13.0|12.8||p value significance level = 5%|ANOVA|||Differences between treatment groups at Visit 5 (Week 10).||12.8|-13.0|0.9882
72494022|NCT02321436|144517101|OTHER|Differences between treatment groups and p-values are based on an analysis of variance performed at each visit, taking into account treatment and spasticity status as fixed effects. Baseline value is value assessed at Visit 1.|Mean Difference (Final Values)|4.6||||0.5646|TWO_SIDED|95.0|-11.9|21.2||p value significance level = 5%|ANOVA|||Differences between treatment groups at Visit 6 (Week 12).||21.2|-11.9|0.5646
72494023|NCT02321436|144517101|OTHER|Differences between treatment groups and p-values are based on an analysis of variance performed at each visit, taking into account treatment and spasticity status as fixed effects. Baseline value is value assessed at Visit 1.|Mean Difference (Final Values)|-12.5||||0.2325|TWO_SIDED|95.0|-34.0|9.0||p value significance level = 5%|ANOVA|||Differences between treatment groups at Visit 7 (Week 16).||9.0|-34.0|0.2325
72494024|NCT02321436|144517101|OTHER|Differences between treatment groups and p-values are based on an analysis of variance performed at each visit, taking into account treatment and spasticity status as fixed effects. Baseline value is value assessed at Visit 1.|Mean Difference (Final Values)|-14.1||||0.2441|TWO_SIDED|95.0|-39.4|11.1||p value significance level = 5%|ANOVA|||Differences between treatment groups at Visit 8 (Week 20).||11.1|-39.4|0.2441
72494025|NCT02321436|144517101|OTHER|Differences between treatment groups and p-values are based on an analysis of variance performed at each visit, taking into account treatment and spasticity status as fixed effects. Baseline value is value assessed at Visit 1.|Mean Difference (Final Values)|-9.0||||0.4311|TWO_SIDED|95.0|-33.7|15.7||p value significance level = 5%|ANOVA|||Differences between treatment groups at Visit 9 (Week 24).||15.7|-33.7|0.4311
72494026|NCT02321436|144517101|OTHER|Differences between treatment groups and p-values are based on an analysis of variance performed at each visit, taking into account treatment and spasticity status as fixed effects. Baseline value is value assessed at Visit 1.|Mean Difference (Final Values)|-4.5||||0.731|TWO_SIDED|95.0|-33.3|24.3||p value significance level = 5%|ANOVA|||Differences between treatment groups at Visit 10 (Week 28).||24.3|-33.3|0.7310
72494027|NCT02321436|144517102|OTHER|||||||0.6128||||||The Cochran-Mantel-Haenszel (CMH) p-value represents the strength of the association between treatment and global assessments of changes at the last visit, adjusted for symptomatic status at baseline.|Cochran-Mantel-Haenszel|p value significance level = 5%||||||0.6128
72557250|NCT03480763|144645365|OTHER|Estimated differences, CIs, and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percent|9.7||||0.002|TWO_SIDED|95.0|3.7|15.6|||Miettinen & Nurminen|||Tiredness/fatigue||15.6|3.7|0.002
72557251|NCT03480763|144645365|OTHER|Estimated differences, CIs, and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percent|1.4||||0.597|TWO_SIDED|95.0|-3.9|6.7|||Miettinen & Nurminen|||Headache||6.7|-3.9|0.597
72557252|NCT03480763|144645365|OTHER|Estimated differences, CIs, and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percent|6.6||||0.016|TWO_SIDED|95.0|1.2|12.1|||Miettinen & Nurminen|||Muscle pain/myalgia||12.1|1.2|0.016
72557253|NCT03480763|144645366|OTHER|Estimated differences, CIs, and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percent|0.1||||0.961|TWO_SIDED|95.0|-4.4|4.7|||Miettinen & Nurminen|||Joint pain/arthralgia||4.7|-4.4|0.961
72557254|NCT03480763|144645366|OTHER|Estimated differences, CIs, and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percent|4.0||||0.252|TWO_SIDED|95.0|-2.8|10.8|||Miettinen & Nurminen|||Tiredness/fatigue||10.8|-2.8|0.252
72557255|NCT03480763|144645366|OTHER|Estimated differences, CIs, and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percent|-0.5||||0.852|TWO_SIDED|95.0|-5.8|4.8|||Miettinen & Nurminen|||Headache||4.8|-5.8|0.852
72557256|NCT03480763|144645366|OTHER|Estimated differences, CIs, and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percent|4.9||||0.125|TWO_SIDED|95.0|-1.4|11.2|||Miettinen & Nurminen|||Muscle pain/myalgia||11.2|-1.4|0.125
72557257|NCT03480763|144645367|OTHER|Estimated differences, CIs, and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percent|0.0|||||TWO_SIDED|95.0|-1.2|1.2||||||Vaccine-related SAEs following V114 or Prevnar 13™||1.2|-1.2|
72557258|NCT03480763|144645368|OTHER|Estimated differences, CIs, and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percent|0.0|||||TWO_SIDED|95.0|-1.3|1.3||||||Vaccine-related SAEs following PNEUMOVAX™23||1.3|-1.3|
72557259|NCT03480763|144645369|OTHER|Geometric mean titer (GMT) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMT Ratio|1.38|||||TWO_SIDED|95.0|1.1|1.74||||||Serotype 1 (Shared)||1.74|1.10|
72618664|NCT01026038|144768107|SUPERIORITY_OR_OTHER||GMC ratio|1.11|||||TWO_SIDED|95.0|0.53|2.3||||||Serotype 3: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||2.30|0.53|
72382090|NCT02398409|144272930|SUPERIORITY||Median Difference (Net)|0.1224|STANDARD_ERROR_OF_MEAN|0.187||0.9974|TWO_SIDED|||||adjusting for the covariates of diagnosis and baseline mean value in caregivers' depression|Mixed Models Analysis|||1 year compared to BL||||.9974
72557260|NCT03480763|144645369|OTHER|GMT ratio and 95% CI are estimated from a cLDA model|GMT Ratio|1.08|||||TWO_SIDED|95.0|0.9|1.29||||||Serotype 3 (Shared)||1.29|0.90|
72557261|NCT03480763|144645369|OTHER|GMT ratio and 95% CI are estimated from a cLDA model.|GMT Ratio|1.06|||||TWO_SIDED|95.0|0.85|1.32||||||Serotype 4 (Shared)||1.32|0.85|
72557262|NCT03480763|144645369|OTHER|GMT ratio and 95% CI are estimated from a cLDA model|GMT Ratio|1.21|||||TWO_SIDED|95.0|0.94|1.56||||||Serotype 5 (Shared)||1.56|0.94|
72557263|NCT03480763|144645369|OTHER|GMT ratio and 95% CI are estimated from a cLDA model.|GMT Ratio|1.16|||||TWO_SIDED|95.0|0.95|1.43||||||Serotype 6A (Shared)||1.43|0.95|
72557264|NCT03480763|144645369|OTHER|GMT ratio and 95% CI are estimated from a cLDA model.|GMT Ratio|1.12|||||TWO_SIDED|95.0|0.93|1.35||||||Serotype 6B (Shared)||1.35|0.93|
72557265|NCT03480763|144645369|OTHER|GMT ratio and 95% CI are estimated from a cLDA model.|GMT Ratio|1.06|||||TWO_SIDED|95.0|0.9|1.25||||||Serotype 7F (Shared)||1.25|0.90|
72557266|NCT03480763|144645369|OTHER|GMT ratio and 95% CI are estimated from a cLDA model.|GMT Ratio|1.1|||||TWO_SIDED|95.0|0.91|1.33||||||Serotype 9V (Shared)||1.33|0.91|
72557267|NCT03480763|144645369|OTHER|GMT ratio and 95% CI are estimated from a cLDA model.|GMT Ratio|1.27|||||TWO_SIDED|95.0|1.05|1.53||||||Serotype 14 (Shared)||1.53|1.05|
72557268|NCT03480763|144645369|OTHER|GMT ratio and 95% CI are estimated from a cLDA model.|GMT Ratio|1.13|||||TWO_SIDED|95.0|0.95|1.34||||||Serotype 18C (Shared)||1.34|0.95|
72618665|NCT01026038|144768107|SUPERIORITY_OR_OTHER||GMC ratio|1.0|||||TWO_SIDED|95.0|0.5|1.97||||||Serotype 3: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.97|0.50|
72557269|NCT03480763|144645369|OTHER|GMT ratio and 95% CI are estimated from a cLDA model.|GMT Ratio|1.15|||||TWO_SIDED|95.0|0.96|1.38||||||Serotype 19A (Shared)||1.38|0.96|
72557270|NCT03480763|144645369|OTHER|GMT ratio and 95% CI are estimated from a cLDA model.|GMT Ratio|1.03|||||TWO_SIDED|95.0|0.89|1.2||||||Serotype 19F (Shared)||1.20|0.89|
72557271|NCT03480763|144645369|OTHER|GMT ratio and 95% CI are estimated from a cLDA model.|GMT Ratio|1.28|||||TWO_SIDED|95.0|1.01|1.61||||||Serotype 23F (Shared)||1.61|1.01|
72557272|NCT03480763|144645369|OTHER|GMT ratio and 95% CI are estimated from a cLDA model.|GMT Ratio|1.63|||||TWO_SIDED|95.0|1.29|2.06||||||Serotype 22F (Unique to V114)||2.06|1.29|
72557273|NCT03480763|144645369|OTHER|GMT ratio and 95% CI are estimated from a cLDA model.|GMT Ratio|0.95|||||TWO_SIDED|95.0|0.77|1.17||||||Serotype 33F (Unique to V114)||1.17|0.77|
72557274|NCT03480763|144645370|OTHER|Geometric mean concentration (GMC) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMC Ratio|0.92|||||TWO_SIDED|95.0|0.79|1.07||||||Serotype 1 (Shared)||1.07|0.79|
72557275|NCT03480763|144645370|OTHER|GMC ratio and 95% CI are estimated from a cLDA model|GMC Ratio|1.0|||||TWO_SIDED|95.0|0.87|1.16||||||Serotype 3 (Shared)||1.16|0.87|
72557276|NCT03480763|144645370|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|0.87|||||TWO_SIDED|95.0|0.74|1.02||||||Serotype 4 (Shared)||1.02|0.74|
72557277|NCT03480763|144645370|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|0.99|||||TWO_SIDED|95.0|0.84|1.18||||||Serotype 5 (Shared)||1.18|0.84|
72382091|NCT02398409|144272931|SUPERIORITY||Median Difference (Net)|0.054|STANDARD_ERROR_OF_MEAN|0.087||0.1918|TWO_SIDED|||||adjusting for the covariates of diagnosis and baseline mean value in caregivers' depression|Mixed Models Analysis|||12 weeks compared to BL||||.1918
72382092|NCT02398409|144272931|SUPERIORITY||Median Difference (Net)|0.046|STANDARD_ERROR_OF_MEAN|0.078||0.9212|TWO_SIDED|||||adjusting for the covariates of diagnosis and baseline mean value in caregivers' depression|Mixed Models Analysis|||6 months compared to BL||||.9212
72382093|NCT02398409|144272931|SUPERIORITY||Median Difference (Net)|0.026|STANDARD_ERROR_OF_MEAN|0.083||0.2358|TWO_SIDED|||||adjusting for the covariates of diagnosis and baseline mean value in caregivers' depression|Mixed Models Analysis|||1 year compared to BL||||.2358
72382094|NCT02398409|144272932|SUPERIORITY|adjusting for the covariates of diagnosis and baseline mean value in caregivers' depression|Median Difference (Net)|0.008|STANDARD_ERROR_OF_MEAN|0.168||0.1107|TWO_SIDED||||||Mixed Models Analysis|||12 weeks compared to BL||||.1107
72494028|NCT04137887|144517105|SUPERIORITY|Superiority of QIV-HD effectiveness over QIV-SD was demonstrated if the lower bound of the Confidence intervals (CIs) for relative vaccine effectiveness (rVE); expressed in percentage (%) was more than (\>) 0%.|Relative Vaccine Effectiveness|5.54|||||TWO_SIDED|95.0|-12.43|20.66|||||rVE: % reduction of 1st occurrence of cardiovascular/respiratory hospitalization cases in QIV-HD group compared to QIV-SD group. 2-sided 95% CIs for rVE was calculated by exact method assuming Binomial distribution of number of cases in both groups.|||20.66|-12.43|
72494029|NCT04137887|144517106|SUPERIORITY|Superiority of QIV-HD effectiveness over QIV-SD was demonstrated if the lower bound of the CIs for rVE, expressed in % was \> 0%.|Relative Vaccine Effectiveness|5.4|||||TWO_SIDED|95.0|-27.99|30.14|||||rVE: % reduction of 1st occurrence of cardiovascular/respiratory hospitalization cases in QIV-HD group compared to QIV-SD group. 2-sided 95% CIs for rVE was calculated by exact method assuming Binomial distribution of number of cases in both groups.|Statistical analysis for diseases of respiratory system.||30.14|-27.99|
72494030|NCT04137887|144517106|SUPERIORITY|Superiority of QIV-HD effectiveness over QIV-SD was demonstrated if the lower bound of the CIs for rVE, expressed in % was \> 0%.|Relative Vaccine Effectiveness|7.09|||||TWO_SIDED|95.0|-15.04|25.0|||||rVE: % reduction of 1st occurrence of cardiovascular/respiratory hospitalization cases in QIV-HD group compared to QIV-SD group. 2-sided 95% CIs for rVE was calculated by exact method assuming Binomial distribution of number of cases in both groups.|Statistical analysis for diseases of circulatory system.||25.00|-15.04|
72494031|NCT01790503|144517130|OTHER||Hazard Ratio (HR)|0.98||||0.456|TWO_SIDED|95.0|0.71|1.36|||Log Rank|||||1.36|0.71|0.456
72494032|NCT01790503|144517130|OTHER||Hazard Ratio (HR)|1.05||||0.619|TWO_SIDED|95.0|0.77|1.43|||Log Rank|||||1.43|0.77|0.619
72494033|NCT01790503|144517130|OTHER||Hazard Ratio (HR)|0.9||||0.272|TWO_SIDED|95.0|0.65|1.26|||Log Rank|||||1.26|0.65|0.272
72494034|NCT01790503|144517131|OTHER|||||||0.44|||||||t-test, 2 sided|||Comparison between age subgroups: 18-64 years vs 65+ years||||0.440
72494035|NCT01790503|144517131|OTHER|||||||0.699|||||||t-test, 2 sided|||Comparison between extent of surgery subgroups: complete resection vs partial resection||||0.699
72494036|NCT01790503|144517131|OTHER|||||||0.003|||||||t-test, 2 sided|||Comparison between baseline KPS subgroups: 70-89 vs 90-100||||0.003
72494037|NCT01790503|144517131|OTHER|||||||0.201|||||||t-test, 2 sided|||Comparison between MGMT status subgroups: methylated vs unmethylated||||0.201
72494038|NCT01790503|144517133|OTHER||Hazard Ratio (HR)|0.94||||0.389|TWO_SIDED|95.0|0.6|1.47|||Log Rank|||||1.47|0.60|0.389
72494039|NCT01790503|144517133|OTHER||Hazard Ratio (HR)|0.94||||0.393|TWO_SIDED|95.0|0.63|1.42|||Log Rank|||||1.42|0.63|0.393
72494040|NCT01790503|144517133|OTHER||Hazard Ratio (HR)|0.98||||0.469|TWO_SIDED|95.0|0.63|1.54|||Log Rank|||||1.54|0.63|0.469
72494041|NCT01790503|144517134|OTHER|||||||0.063|||||||t-test, 2 sided|||Comparison between age subgroups: 18-64 years vs 65+ years||||0.063
72494042|NCT01790503|144517134|OTHER|||||||0.969|||||||t-test, 2 sided|||Comparison between extent of surgery subgroups: complete resection vs partial resection||||0.969
72494043|NCT01790503|144517134|OTHER||||||<|0.001|||||||t-test, 2 sided|||Comparison between baseline KPS subgroups: 70-89 vs 90-100||||<0.001
72494044|NCT01790503|144517134|OTHER|||||||0.501|||||||t-test, 2 sided|||Comparison between MGMT status subgroups: methylated vs unmethylated||||0.501
72494045|NCT01790503|144517135|OTHER|||||||0.705|||||||t-test, 2 sided|||Comparison between age subgroups: 18-64 years vs 65+ years||||0.705
72382095|NCT02398409|144272932|SUPERIORITY|adjusting for the covariates of diagnosis and baseline mean value in caregivers' depression|Median Difference (Net)|0.251|STANDARD_ERROR_OF_MEAN|0.211||0.0562|TWO_SIDED||||||Mixed Models Analysis|||6 months compared to BL||||.0562
72382096|NCT02398409|144272932|SUPERIORITY||Median Difference (Net)|0.226|STANDARD_ERROR_OF_MEAN|0.218||0.8579|TWO_SIDED|||||adjusting for the covariates of diagnosis and baseline mean value in caregivers' depression|Mixed Models Analysis|||1 year compared to BL||||.8579
72494046|NCT01790503|144517135|OTHER||||||>|0.999|||||||t-test, 2 sided|||Comparison between extent of surgery subgroups: complete resection vs partial resection||||>0.999
72494047|NCT01790503|144517135|OTHER|||||||0.099|||||||t-test, 2 sided|||Comparison between baseline KPS subgroups: 70-89 vs 90-100||||0.099
72494048|NCT01790503|144517135|OTHER|||||||0.348|||||||t-test, 2 sided|||Comparison between MGMT status subgroups: methylated vs unmethylated||||0.348
72494049|NCT00741156|144517155|SUPERIORITY_OR_OTHER|||||||0.09|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.09
72494050|NCT02762513|144517160|OTHER||Median overall survival time (months)|9.8|||||TWO_SIDED|95.0|||||||Median calculated by Kaplan-Meier method.|||||
72494051|NCT02762513|144517161|OTHER||Median PFS time (months)|3.5|||||TWO_SIDED|95.0|||||||Median calculated by Kaplan-Meier method.|||||
72494052|NCT01390909|144517164|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|849.0|||<|0.0001|TWO_SIDED|95.0|786.0|921.0||Adjusted Cost Differences in Prescription Drug Costs, AEDs|Ordinary Least Squares Regression|Ordinary least squares regression was used to adjust differences. Covariates were gender, age, region, comorbidities, baseline treatment, and costs.|Confidence intervals were calculated using a nonparametric bootstrap with 999 replications.|||921|786|<0.0001
72557278|NCT03480763|144645370|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|1.16|||||TWO_SIDED|95.0|0.96|1.41||||||Serotype 6A (Shared)||1.41|0.96|
72557279|NCT03480763|144645370|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|1.16|||||TWO_SIDED|95.0|0.96|1.4||||||Serotype 6B (Shared)||1.40|0.96|
72557280|NCT03480763|144645370|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|0.99|||||TWO_SIDED|95.0|0.85|1.16||||||Serotype 7F (Shared)||1.16|0.85|
72557281|NCT03480763|144645370|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|1.04|||||TWO_SIDED|95.0|0.89|1.22||||||Serotype 9V (Shared)||1.22|0.89|
72557282|NCT03480763|144645370|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|1.17|||||TWO_SIDED|95.0|0.98|1.39||||||Serotype 14 (Shared)||1.39|0.98|
72557283|NCT03480763|144645370|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|1.16|||||TWO_SIDED|95.0|1.0|1.36||||||Serotype 18C (Shared)||1.36|1.00|
72557284|NCT03480763|144645370|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|1.1|||||TWO_SIDED|95.0|0.95|1.29||||||Serotype 19A (Shared)||1.29|0.95|
72557285|NCT03480763|144645370|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|1.09|||||TWO_SIDED|95.0|0.93|1.27||||||Serotype 19F (Shared)||1.27|0.93|
72557286|NCT03480763|144645370|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|1.14|||||TWO_SIDED|95.0|0.96|1.35||||||Serotype 23F (Shared)||1.35|0.96|
72557287|NCT03480763|144645370|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|1.43|||||TWO_SIDED|95.0|1.16|1.77||||||Serotype 22F (Unique to V114)||1.77|1.16|
72557288|NCT03480763|144645370|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|0.8|||||TWO_SIDED|95.0|0.67|0.95||||||Serotype 33F (Unique to V114)||0.95|0.67|
72557289|NCT03480763|144645371|OTHER|GMT ratio and 95% CI are estimated from a cLDA model.|GMT Ratio|1.22|||||TWO_SIDED|95.0|0.94|1.58||||||Serotype 1 (Shared)||1.58|0.94|
72557290|NCT03480763|144645371|OTHER|GMT ratio and 95% CI are estimated from a cLDA model.|GMT Ratio|1.9|||||TWO_SIDED|95.0|1.56|2.3||||||Serotype 3 (Shared)||2.30|1.56|
72557291|NCT03480763|144645371|OTHER|GMT ratio and 95% CI are estimated from a cLDA model.|GMT Ratio|0.76|||||TWO_SIDED|95.0|0.6|0.97||||||Serotype 4 (Shared)||0.97|0.60|
72557292|NCT03480763|144645371|OTHER|GMT ratio and 95% CI are estimated from a cLDA model.|GMT Ratio|1.07|||||TWO_SIDED|95.0|0.81|1.4||||||Serotype 5 (Shared)||1.40|0.81|
72557293|NCT03480763|144645371|OTHER|GMT ratio and 95% CI are estimated from a cLDA model.|GMT Ratio|1.19|||||TWO_SIDED|95.0|0.92|1.53||||||Serotype 6A (Shared)||1.53|0.92|
72557294|NCT03480763|144645371|OTHER|GMT ratio and 95% CI are estimated from a cLDA model.|GMT Ratio|1.64|||||TWO_SIDED|95.0|1.31|2.06||||||Serotype 6B (Shared)||2.06|1.31|
72557295|NCT03480763|144645371|OTHER|GMT ratio and 95% CI are estimated from a cLDA model.|GMT Ratio|0.95|||||TWO_SIDED|95.0|0.8|1.14||||||Serotype 7F (Shared)||1.14|0.80|
72557296|NCT03480763|144645371|OTHER|GMT ratio and 95% CI are estimated from a cLDA model.|GMT Ratio|1.02|||||TWO_SIDED|95.0|0.83|1.24||||||Serotype 9V (Shared)||1.24|0.83|
72557297|NCT03480763|144645371|OTHER|GMT ratio and 95% CI are estimated from a cLDA model.|GMT Ratio|1.09|||||TWO_SIDED|95.0|0.87|1.37||||||Serotype 14 (Shared)||1.37|0.87|
72557298|NCT03480763|144645371|OTHER|GMT ratio and 95% CI are estimated from a cLDA model.|GMT Ratio|1.48|||||TWO_SIDED|95.0|1.2|1.84||||||Serotype 18C (Shared)||1.84|1.20|
72382097|NCT00089674|144272936|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.7|||<|0.0001||95.0|6.2|7.1|||ANCOVA|||||7.1|6.2|<0.0001
72557299|NCT03480763|144645371|OTHER|GMT ratio and 95% CI are estimated from a cLDA model.|GMT Ratio|1.28|||||TWO_SIDED|95.0|1.06|1.55||||||Serotype 19A (Shared)||1.55|1.06|
72557300|NCT03480763|144645371|OTHER|GMT ratio and 95% CI are estimated from a cLDA model.|GMT Ratio|1.1|||||TWO_SIDED|95.0|0.92|1.32||||||Serotype 19F (Shared)||1.32|0.92|
72557301|NCT03480763|144645371|OTHER|GMT ratio and 95% CI are estimated from a cLDA model.|GMT Ratio|1.53|||||TWO_SIDED|95.0|1.18|2.0||||||Serotype 23F (Shared)||2.00|1.18|
72557302|NCT03480763|144645371|OTHER|GMT ratio and 95% CI are estimated from a cLDA model.|GMT Ratio|34.86|||||TWO_SIDED|95.0|26.13|46.5||||||Serotype 22F (Unique to V114)||46.50|26.13|
72557303|NCT03480763|144645371|OTHER|GMT ratio and 95% CI are estimated from a cLDA model.|GMT Ratio|9.15|||||TWO_SIDED|95.0|7.48|11.2||||||Serotype 33F (Unique to V114)||11.20|7.48|
72557304|NCT03480763|144645372|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|0.89|||||TWO_SIDED|95.0|0.72|1.09||||||Serotype 1 (Shared)||1.09|0.72|
72557305|NCT03480763|144645372|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|1.74|||||TWO_SIDED|95.0|1.46|2.07||||||Serotype 3 (Shared)||2.07|1.46|
72557306|NCT03480763|144645372|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|0.79|||||TWO_SIDED|95.0|0.64|0.99||||||Serotype 4 (Shared)||0.99|0.64|
72557307|NCT03480763|144645372|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|1.04|||||TWO_SIDED|95.0|0.84|1.3||||||Serotype 5 (Shared)||1.30|0.84|
72557308|NCT03480763|144645372|OTHER|GMCs, GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|1.4|||||TWO_SIDED|95.0|1.1|1.77||||||Serotype 6A (Shared)||1.77|1.10|
72557309|NCT03480763|144645372|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|1.64|||||TWO_SIDED|95.0|1.28|2.1||||||Serotype 6B (Shared)||2.10|1.28|
72557310|NCT03480763|144645372|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|0.91|||||TWO_SIDED|95.0|0.74|1.13||||||Serotype 7F (Shared)||1.13|0.74|
72557311|NCT03480763|144645372|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|1.13|||||TWO_SIDED|95.0|0.91|1.41||||||Serotype 9V (Shared)||1.41|0.91|
72557312|NCT03480763|144645372|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|1.09|||||TWO_SIDED|95.0|0.87|1.38||||||Serotype 14 (Shared)||1.38|0.87|
72557313|NCT03480763|144645372|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|1.56|||||TWO_SIDED|95.0|1.27|1.92||||||Serotype 18C (Shared)||1.92|1.27|
72557314|NCT03480763|144645372|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|1.13|||||TWO_SIDED|95.0|0.91|1.39||||||Serotype 19A (Shared)||1.39|0.91|
72557315|NCT03480763|144645372|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|1.14|||||TWO_SIDED|95.0|0.92|1.41||||||Serotype 19F (Shared)||1.41|0.92|
72557316|NCT03480763|144645372|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|1.61|||||TWO_SIDED|95.0|1.27|2.04||||||Serotype 23F (Shared)||2.04|1.27|
72557317|NCT03480763|144645372|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|16.54|||||TWO_SIDED|95.0|13.78|19.86||||||Serotype 22F (Unique to V114)||19.86|13.78|
72557318|NCT03480763|144645372|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|12.82|||||TWO_SIDED|95.0|10.82|15.19||||||Serotype 33F (Unique to V114)||15.19|10.82|
72557319|NCT03480763|144645377|OTHER|GMT ratio and 95% CI are estimated from a cLDA model.|GMT Ratio|1.19|||||TWO_SIDED|95.0|0.92|1.53||||||Serotype 1 (Shared)||1.53|0.92|
72557320|NCT03480763|144645377|OTHER|GMT ratio and 95% CI are estimated from a cLDA model.|GMT Ratio|1.57|||||TWO_SIDED|95.0|1.29|1.9||||||Serotype 3 (Shared)||1.90|1.29|
72382098|NCT00089674|144272937|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.9|||<|0.0001||95.0|3.5|4.4||Adjusted for multiplicity using the prespecified hierarchical analysis strategy and Hochberg procedure|ANCOVA|||||4.4|3.5|<0.0001
72382099|NCT00089674|144272938|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.8|||<|0.0001||95.0|4.4|5.1||Adjusted for multiplicity using the prespecified hierarchical analysis strategy and Hochberg procedure|ANCOVA|||||5.1|4.4|<0.0001
72382100|NCT00089674|144272939|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.9|||<|0.0001||95.0|7.4|8.4||Adjusted for multiplicity using the prespecified hierarchical analysis strategy and Hochberg procedure|ANCOVA|||||8.4|7.4|<0.0001
72382101|NCT00089674|144272940|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.9|||<|0.0001||95.0|4.4|5.4||Adjusted for multiplicity using the prespecified hierarchical analysis strategy and Hochberg procedure|ANCOVA|||||5.4|4.4|<0.0001
72382102|NCT00089674|144272941|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.7|||<|0.0001||95.0|5.4|6.1||Adjusted for multiplicity using the prespecified hierarchical analysis strategy and Hochberg procedure|ANCOVA|||||6.1|5.4|<0.0001
72382103|NCT00089674|144272942|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.7||||0.1048||95.0|0.46|1.08||Adjusted for multiplicity using the prespecified hierarchical analysis strategy and Hochberg procedure|Regression, Logistic|||||1.08|0.46|0.1048
72382104|NCT00089674|144272943|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.37||||0.0125||95.0|0.18|0.78||Adjusted for multiplicity using the prespecified hierarchical analysis strategy and Hochberg procedure|Regression, Logistic|||||0.78|0.18|0.0125
72382105|NCT00089674|144272944|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.94||||0.7961||95.0|0.57|1.55||Adjusted for multiplicity using the prespecified hierarchical analysis strategy and Hochberg procedure|Regression, Cox|||||1.55|0.57|0.7961
72382106|NCT00089674|144272945|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.7||||0.7961||95.0|0.44|1.11||Adjusted for multiplicity using the prespecified hierarchical analysis strategy and Hochberg procedure|Regression, Logistic|||||1.11|0.44|0.7961
72382107|NCT03963401|144272946|SUPERIORITY||Mean Difference (Final Values)|21.23|STANDARD_ERROR_OF_MEAN|10.51||0.1172|TWO_SIDED|90.0|3.94|38.52|||Normal approximation, Dunnett's method|||||38.52|3.94|0.1172
72382108|NCT03963401|144272946|SUPERIORITY||Median Difference (Final Values)|23.38|STANDARD_ERROR_OF_MEAN|8.58||0.0197|TWO_SIDED|90.0|9.26|37.5|||Normal approximation, Dunnett's Method|||||37.50|9.26|0.0197
72382109|NCT03963401|144272946|SUPERIORITY||Median Difference (Final Values)|31.29|STANDARD_ERROR_OF_MEAN|8.29||0.0006|TWO_SIDED|90.0|17.65|44.93|||Normal approximation, Dunnett's Method|||||44.93|17.65|0.0006
72434375|NCT00708097|144381967|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|1175.62|||<|0.0001|TWO_SIDED|95.0|869.15|1482.1||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment and period with subject as a random effect.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered population means of the treatments in comparison, to be equal with respect to EFU. Statistical tests were 2-sided with a significance level of 0.05.||1482.10|869.15|<0.0001
72434376|NCT02162446|144381970|OTHER|||||||0.016|||||||Wilcoxon signed rank test|||Comparison of malignant lesions in total tissues between previous somatostatin receptor scan (ITT population pre-dose) and the 68Ga-OPS202 visit 1 receptor scan (ITT population Day 0) at 1 hour time point.||||0.016
72618666|NCT01026038|144768107|SUPERIORITY_OR_OTHER||GMC ratio|0.9|||||TWO_SIDED|95.0|0.39|2.07||||||Serotype 3: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||2.07|0.39|
72382110|NCT03963401|144272947|SUPERIORITY||Mean Difference (Final Values)|20.95|STANDARD_ERROR_OF_MEAN|11.09||0.0588|TWO_SIDED|90.0|2.72|39.19|||Normal approximation method|||||39.19|2.72|0.0588
72382111|NCT03963401|144272947|SUPERIORITY||Median Difference (Final Values)|26.31|STANDARD_ERROR_OF_MEAN|8.87||0.003|TWO_SIDED|90.0|11.72|40.9|||Normal approximation method|||||40.90|11.72|0.0030
72382112|NCT03963401|144272947|SUPERIORITY||Median Difference (Final Values)|31.21|STANDARD_ERROR_OF_MEAN|8.68||0.0003|TWO_SIDED|90.0|16.93|45.5|||Normal approximation method|||||45.50|16.93|0.0003
72382113|NCT02961218|144272976|SUPERIORITY||Mean Difference (Net)|-0.07|STANDARD_DEVIATION|0.57||0.55|TWO_SIDED|90.0|-1.03|0.85||probability reduction of average pain score in ACZ885 \> Placebo|Bayesian model for repeated measures||Lower limit and upper limit represents the credibility interval from the Bayesian analysis.|||0.85|-1.03|0.55
72382114|NCT02961218|144272978|SUPERIORITY||Ratio|0.408||||0.002|TWO_SIDED|90.0|0.253|0.658|||Mixed-effect Model for Repeated Measures|||||0.658|0.253|0.002
72382115|NCT02961218|144272979|SUPERIORITY||Ratio|0.752|||<|0.001|TWO_SIDED|90.0|0.657|0.862|||Mixed-effect Model for Repeated Measures|||||0.862|0.657|<.001
72382116|NCT02961218|144272980|SUPERIORITY||Ratio|0.682||||0.004|TWO_SIDED|90.0|0.547|0.849|||Mixed-effect Model for Repeated Measures|||||0.849|0.547|0.004
72382117|NCT02961218|144272981|SUPERIORITY||Ratio|0.718||||0.032|TWO_SIDED|90.0|0.556|0.925|||Mixed-effect Model for Repeated Measures|||||0.925|0.556|0.032
72382118|NCT02961218|144272988|SUPERIORITY||Ratio|1.4|STANDARD_ERROR_OF_MEAN|0.45||0.455|TWO_SIDED|90.0|0.58|3.4|||Generalized Linear Model (GLM)|||||3.40|0.58|0.455
72434377|NCT02162446|144381970|OTHER|||||||0.004|||||||Wilcoxon signed rank test|||Comparison of malignant lesions in total tissues between previous somatostatin receptor scan (ITT population pre-dose) and the 68Ga-OPS202 visit 2 receptor scan (ITT population Day 21) at 1 hour time point.||||0.004
72557321|NCT03480763|144645377|OTHER|GMT ratio and 95% CI are estimated from a cLDA model.|GMT Ratio|0.72|||||TWO_SIDED|95.0|0.57|0.9||||||Serotype 4 (Shared)||0.90|0.57|
72557322|NCT03480763|144645377|OTHER|GMT ratio and 95% CI are estimated from a cLDA model.|GMT Ratio|1.02|||||TWO_SIDED|95.0|0.78|1.33||||||Serotype 5 (Shared)||1.33|0.78|
72557323|NCT03480763|144645377|OTHER|GMT ratio and 95% CI are estimated from a cLDA model.|GMT Ratio|1.15|||||TWO_SIDED|95.0|0.93|1.41||||||Serotype 6A (Shared)||1.41|0.93|
72557324|NCT03480763|144645377|OTHER|GMT ratio and 95% CI are estimated from a cLDA model.|GMT Ratio|1.43|||||TWO_SIDED|95.0|1.16|1.77||||||Serotype 6B (Shared)||1.77|1.16|
72434378|NCT02162446|144381970|OTHER|||||||0.012|||||||Wilcoxon signed rank test|||Comparison of malignant lesions in liver between previous somatostatin receptor scan (ITT population pre-dose) and the 68Ga-OPS202 visit 1 receptor scan (ITT population Day 0) at 1 hour time point.||||0.012
72434379|NCT02162446|144381970|OTHER|||||||0.004|||||||Wilcoxon signed rank test|||Comparison of malignant lesions in liver between previous somatostatin receptor scan (ITT population pre-dose) and the 68Ga-OPS202 visit 2 receptor scan (ITT population Day 21) at 1 hour time point.||||0.004
72434380|NCT02162446|144381970|OTHER|||||||0.5|||||||Wilcoxon signed rank test|||Comparison of malignant lesions in lymph node between previous somatostatin receptor scan (ITT population pre-dose) and the 68Ga-OPS202 visit 1 receptor scan (ITT population Day 0) at 1 hour time point.||||0.500
72434381|NCT02162446|144381970|OTHER|||||||1|||||||Wilcoxon signed rank test|||Comparison of malignant lesions in lymph node between previous somatostatin receptor scan (ITT population pre-dose) and the 68Ga-OPS202 visit 2 receptor scan (ITT population Day 21) at 1 hour time point.||||1.000
72434382|NCT02162446|144381972|OTHER|||||||0.25|||||||Wilcoxon signed rank test|||Comparison of SUVmax of malignant lesions in liver between previous somatostatin receptor scan (ITT population pre-dose) and the 68Ga-OPS202 visit 1 receptor scan (ITT population Day 0) at 1 hour time point.||||0.250
72434383|NCT02162446|144381972|OTHER|||||||0.004|||||||Wilcoxon signed rank test|||Comparison of SUVmax of malignant lesions in liver between previous somatostatin receptor scan (ITT population pre-dose) and the 68Ga-OPS202 visit 2 receptor scan (ITT population Day 21) at 1 hour time point.||||0.004
72434384|NCT02162446|144381972|OTHER|||||||0.688|||||||Wilcoxon signed rank test|||Comparison of SUVmax of malignant lesions in lymph node between previous somatostatin receptor scan (ITT population pre-dose) and the 68Ga-OPS202 visit 1 receptor scan (ITT population Day 0) at 1 hour time point.||||0.688
72434385|NCT02162446|144381972|OTHER|||||||0.578|||||||Wilcoxon signed rank test|||Comparison of SUVmax of malignant lesions in lymph node between previous somatostatin receptor scan (ITT population pre-dose) and the 68Ga-OPS202 visit 2 receptor scan (ITT population Day 21) at 1 hour time point.||||0.578
72434386|NCT02162446|144381973|OTHER|||||||0.027|||||||Wilcoxon signed rank test|||Comparison of SUVmax of malignant lesions in liver between 68Ga-OPS202 visit 1 receptor scan (ITT population Day 0) and the 68Ga-OPS202 visit 2 receptor scan (ITT population Day 21) at 1 hour time point.||||0.027
72434387|NCT02162446|144381973|OTHER|||||||0.219|||||||Wilcoxon signed rank test|||Comparison of SUVmax of malignant lesions in lymph node between 68Ga-OPS202 visit 1 receptor scan (ITT population Day 0) and the 68Ga-OPS202 visit 2 receptor scan (ITT population Day 21) at 1 hour time point.||||0.219
72434388|NCT02162446|144381974|OTHER|||||||0.064|||||||Wilcoxon signed rank test|||Comparison of SUVmax of RT in muscle between previous somatostatin receptor scan (ITT population pre-dose) and the 68Ga-OPS202 visit 1 receptor scan (ITT population Day 0) at 1 hour time point.||||0.064
72434389|NCT02162446|144381974|OTHER|||||||0.339|||||||Wilcoxon signed rank test|||Comparison of SUVmax of RT in muscle between previous somatostatin receptor scan (ITT population pre-dose) and the 68Ga-OPS202 visit 2 receptor scan (ITT population Day 21) at 1 hour time point.||||0.339
72494053|NCT01390909|144517164|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|1879.0|||<|0.0001|TWO_SIDED|95.0|1636.0|2112.0||Adjusted Cost Differences in Prescription Drug Costs, nonAEDs|Ordinary Least Squares Regression|Ordinary least squares regression was used to adjust differences. Covariates were gender, age, region, comorbidities, baseline treatment, and costs.|Confidence intervals were calculated using a nonparametric bootstrap with 999 replications.|||2112|1636|<0.0001
72434390|NCT02162446|144381974|OTHER|||||||0.001|||||||Wilcoxon signed rank test|||Comparison of SUVmax of RT in liver between previous somatostatin receptor scan (ITT population pre-dose) and the 68Ga-OPS202 visit 1 receptor scan (ITT population Day 0) at 1 hour time point.||||0.001
72434391|NCT02162446|144381974|OTHER|||||||0|||||||Wilcoxon signed rank test|||Comparison of SUVmax of RT in liver between previous somatostatin receptor scan (ITT population pre-dose) and the 68Ga-OPS202 visit 2 receptor scan (ITT population Day 21) at 1 hour time point.||||0.000
72434392|NCT02162446|144381974|OTHER|||||||0.297|||||||Wilcoxon signed rank test|||Comparison of SUVmax of RT in lymph node between previous somatostatin receptor scan (ITT population pre-dose) and the 68Ga-OPS202 visit 1 receptor scan (ITT population Day 0) at 1 hour time point.||||0.297
72557325|NCT03480763|144645377|OTHER|GMT ratio and 95% CI are estimated from a cLDA model.|GMT Ratio|0.94|||||TWO_SIDED|95.0|0.8|1.11||||||Serotype 7F (Shared)||1.11|0.80|
72434393|NCT02162446|144381974|OTHER|||||||1|||||||Wilcoxon signed rank test|||Comparison of SUVmax of RT in lymph node between previous somatostatin receptor scan (ITT population pre-dose) and the 68Ga-OPS202 visit 2 receptor scan (ITT population Day 21) at 1 hour time point.||||1.000
72434394|NCT02162446|144381975|OTHER|||||||0.47|||||||Wilcoxon signed rank test|||Comparison of SUVmax of RT in muscle between 68Ga-OPS202 visit 1 receptor scan (ITT population Day 0) and the 68Ga-OPS202 visit 2 receptor scan (ITT population Day 21) at 1 hour time point.||||0.470
72434395|NCT02162446|144381975|OTHER|||||||0.233|||||||Wilcoxon signed rank test|||Comparison of SUVmax of RT in liver between 68Ga-OPS202 visit 1 receptor scan (ITT population Day 0) and the 68Ga-OPS202 visit 2 receptor scan (ITT population Day 21) at 1 hour time point.||||0.233
72434396|NCT02162446|144381975|OTHER|||||||0.375|||||||Wilcoxon signed rank test|||Comparison of SUVmax of RT in lymph node between 68Ga-OPS202 visit 1 receptor scan (ITT population Day 0) and the 68Ga-OPS202 visit 2 receptor scan (ITT population Day 21) at 1 hour time point.||||0.375
72434397|NCT02162446|144381976|OTHER|||||||0.004|||||||Wilcoxon signed rank test|||Comparison of 3D-SUV-R of malignant lesions in liver with RT as liver between previous somatostatin receptor scan (ITT population pre-dose) and the 68Ga-OPS202 visit 1 receptor scan (ITT population Day 0) at 1 hour time point.||||0.004
72434398|NCT02162446|144381976|OTHER|||||||0.004|||||||Wilcoxon signed rank test|||Comparison of 3D-SUV-R of malignant lesions in liver with RT as liver between previous somatostatin receptor scan (ITT population pre-dose) and the 68Ga-OPS202 visit 2 receptor scan (ITT population Day 21) at 1 hour time point.||||0.004
72434399|NCT02162446|144381976|OTHER|||||||0.426|||||||Wilcoxon signed rank test|||Comparison of 3D-SUV-R of malignant lesions in liver with RT as muscle between previous somatostatin receptor scan (ITT population pre-dose) and the 68Ga-OPS202 visit 1 receptor scan (ITT population Day 0) at 1 hour time point.||||0.426
72434400|NCT02162446|144381976|OTHER|||||||0.098|||||||Wilcoxon signed rank test|||Comparison of 3D-SUV-R of malignant lesions in liver with RT as muscle between previous somatostatin receptor scan (ITT population pre-dose) and the 68Ga-OPS202 visit 2 receptor scan (ITT population Day 21) at 1 hour time point.||||0.098
72382119|NCT05298306|144273005|SUPERIORITY|No formal sample size estimation was undertaken due to the exploratory nature of the study. Analysis was based a mixed model repeated measures model, with fixed-effects including treatment, time point and period factors. Baseline was included as a covariate. Random effects for participants and participant by period were also included.|Mean Difference (Net)|-0.25||||0.5196|TWO_SIDED|95.0|-1.02|0.52||No adjustment for multiple comparisons was made due to the exploratory nature of the study|Mixed Models Analysis||Difference is LAT8881 minus placebo|Change from baseline VAS score at 0.25 hours||0.52|-1.02|0.5196
72382120|NCT05298306|144273005|SUPERIORITY|No formal sample size estimation was undertaken due to the exploratory nature of the study. Analysis was based a mixed model repeated measures model, with fixed-effects including treatment, time point and period factors. Baseline was included as a covariate. Random effects for participants and participant by period were also included.|Mean Difference (Net)|-0.32||||0.3983|TWO_SIDED|95.0|-1.09|0.44||No adjustment for multiple comparisons has been made due to the exploratory nature of the study|Mixed Models Analysis||Difference is LAT8881 minus placebo|Change in VAS score from baseline at 0.5 hours||0.44|-1.09|0.3983
72382121|NCT05298306|144273005|SUPERIORITY|No formal sample size estimation was undertaken due to the exploratory nature of the study. Analysis was based a mixed model repeated measures model, with fixed-effects including treatment, time point and period factors. Baseline was included as a covariate. Random effects for participants and participant by period were also included.|Mean Difference (Net)|-0.26||||0.489|TWO_SIDED|95.0|-1.03|0.5||No adjustment for multiple comparisons was made due to the exploratory nature of the study|Mixed Models Analysis||Difference is LAT8881 minus placebo|Change from baseline VAS score at 0.75 hours||0.5|-1.03|0.4890
72382122|NCT05298306|144273005|SUPERIORITY|No formal sample size estimation was undertaken due to the exploratory nature of the study. Analysis was based a mixed model repeated measures model, with fixed-effects including treatment, time point and period factors. Baseline was included as a covariate. Random effects for participants and participant by period were also included.|Mean Difference (Net)|-0.21||||0.5903|TWO_SIDED|95.0|-0.97|0.56||No adjustment for multiple comparisons was made due to the exploratory nature of the study|Mixed Models Analysis||Difference is LAT8881 minus placebo|Change from baseline VAS score at 1 hour||0.56|-0.97|0.5903
72382123|NCT05298306|144273005|SUPERIORITY|No formal sample size estimation was undertaken due to the exploratory nature of the study. Analysis was based a mixed model repeated measures model, with fixed-effects including treatment, time point and period factors. Baseline was included as a covariate. Random effects for participants and participant by period were also included.|Mean Difference (Net)|-0.13||||0.7352|TWO_SIDED|95.0|-0.9|0.64||No adjustment for multiple comparisons was made due to the exploratory nature of the study.|Mixed Models Analysis||Difference is LAT8881 minus placebo.|Change from baseline VAS score at 1.5 hours||0.64|-0.90|0.7352
72382124|NCT05298306|144273005|SUPERIORITY|No formal sample size estimation was undertaken due to the exploratory nature of the study. Analysis was based a mixed model repeated measures model, with fixed-effects including treatment, time point and period factors. Baseline was included as a covariate. Random effects for participants and participant by period were also included.|Mean Difference (Net)|-0.15||||0.6892|TWO_SIDED|95.0|-0.92|0.61||No adjustment for multiple comparisons was made due to the exploratory nature of the study.|Mixed Models Analysis||Difference is LAT8881 minus placebo.|Change from baseline VAS score at 2 hours||0.61|-0.92|0.6892
72382125|NCT05298306|144273005|SUPERIORITY|No formal sample size estimation was undertaken due to the exploratory nature of the study. Analysis was based a mixed model repeated measures model, with fixed-effects including treatment, time point and period factors. Baseline was included as a covariate. Random effects for participants and participant by period were also included.|Mean Difference (Net)|-0.01||||0.9767|TWO_SIDED|95.0|-0.78|0.76||No adjustment for multiple comparisons was made due to the exploratory nature of the study.|Mixed Models Analysis||Difference is LAT8881 minus placebo.|Change from baseline VAS score at 2.5 hours||0.76|-0.78|0.9767
72382126|NCT05298306|144273005|SUPERIORITY|No formal sample size estimation was undertaken due to the exploratory nature of the study. Analysis was based a mixed model repeated measures model, with fixed-effects including treatment, time point and period factors. Baseline was included as a covariate. Random effects for participants and participant by period were also included.|Median Difference (Net)|0.32||||0.3964|TWO_SIDED|95.0|-0.44|1.09||No adjustment for multiple comparisons was made due to the exploratory nature of the study.|Mixed Models Analysis||Difference is LAT8881 minus placebo.|Change from baseline VAS score at 3 hours||1.09|-0.44|0.3964
72382127|NCT05298306|144273005|SUPERIORITY|No formal sample size estimation was undertaken due to the exploratory nature of the study. Analysis was based a mixed model repeated measures model, with fixed-effects including treatment, time point and period factors. Baseline was included as a covariate. Random effects for participants and participant by period were also included.|Mean Difference (Net)|0.22||||0.5669|TWO_SIDED|95.0|-0.55|0.98||No adjustment for multiple comparisons was made due to the exploratory nature of the study.|Mixed Models Analysis||Difference is LAT8881 minus placebo.|Change from baseline VAS score at 3.5 hours||0.98|-0.55|0.5669
72382128|NCT05298306|144273005|SUPERIORITY|No formal sample size estimation was undertaken due to the exploratory nature of the study. Analysis was based a mixed model repeated measures model, with fixed-effects including treatment, time point and period factors. Baseline was included as a covariate. Random effects for participants and participant by period were also included.|Mean Difference (Net)|-0.15||||0.7006|TWO_SIDED|95.0|-0.91|0.62||No adjustment for multiple comparisons was made due to the exploratory nature of the study.|Mixed Models Analysis||Difference is LAT8881 minus placebo.|Change from baseline VAS score at 4 hours||0.62|-0.91|0.7006
72434401|NCT02162446|144381976|OTHER|||||||0.813|||||||Wilcoxon signed rank test|||Comparison of 3D-SUV-R of malignant lesions in lymph node with RT as lymph node between previous somatostatin receptor scan (ITT population pre-dose) and the 68Ga-OPS202 visit 1 receptor scan (ITT population Day 0) at 1 hour time point.||||0.813
72434402|NCT02162446|144381976|OTHER|||||||0.813|||||||Wilcoxon signed rank test|||Comparison of 3D-SUV-R of malignant lesions in lymph node with RT as lymph node between previous somatostatin receptor scan (ITT population pre-dose) and the 68Ga-OPS202 visit 2 receptor scan (ITT population Day 21) at 1 hour time point.||||0.813
72434403|NCT02162446|144381976|OTHER|||||||0.297|||||||Wilcoxon signed rank test|||Comparison of 3D-SUV-R of malignant lesions in lymph node with RT as muscle between previous somatostatin receptor scan (ITT population pre-dose) and the 68Ga-OPS202 visit 1 receptor scan (ITT population Day 0) at 1 hour time point.||||0.297
72557326|NCT03480763|144645377|OTHER|GMT ratio and 95% CI are estimated from a cLDA model.|GMT Ratio|0.98|||||TWO_SIDED|95.0|0.81|1.18||||||Serotype 9V (Shared)||1.18|0.81|
72382129|NCT05298306|144273005|SUPERIORITY|No formal sample size estimation was undertaken due to the exploratory nature of the study. Analysis was based a mixed model repeated measures model, with fixed-effects including treatment, time point and period factors. Baseline was included as a covariate. Random effects for participants and participant by period were also included.|Mean Difference (Net)|-0.1||||0.794|TWO_SIDED|95.0|-0.87|0.67||No adjustment for multiple comparisons was made due to the exploratory nature of the study.|Mixed Models Analysis||Difference is LAT8881 minus placebo.|Change from baseline VAS score at 5 hours||0.67|-0.87|0.7940
72382130|NCT05298306|144273005|SUPERIORITY|No formal sample size estimation was undertaken due to the exploratory nature of the study. Analysis was based a mixed model repeated measures model, with fixed-effects including treatment, time point and period factors. Baseline was included as a covariate. Random effects for participants and participant by period were also included.|Mean Difference (Net)|-0.15||||0.6892|TWO_SIDED|95.0|-0.92|0.61|||Mixed Models Analysis|No adjustment for multiple comparisons was made due to the exploratory nature of the study.||Change from baseline VAS score at 6 hours|Difference is LAT8881 minus placebo.|0.61|-0.92|0.6892
72382131|NCT01352468|144273035|SUPERIORITY_OR_OTHER|||||||0.35|||||||ANCOVA|Controlling for baseline scores||||||.35
72382132|NCT01352468|144273036|SUPERIORITY_OR_OTHER|||||||0.68|||||||ANCOVA|Controlling for baseline scores||||||.68
72382133|NCT01352468|144273037|SUPERIORITY_OR_OTHER|||||||0.57|||||||ANCOVA|Controlling for baseline scores||||||.57
72382134|NCT01178073|144273038|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.502||||0.0002|TWO_SIDED|95.0|0.348|0.724|||Stratified Log Rank||Analysis of time to first adjudicated clinical failure event through FAV. HR is calculated using the Cox proportional hazards model. HR is for Combination Therapy: Ambrisentan + Tadalafil / Monotherapy Pooled: Ambrisentan or Tadalafil.|||0.724|0.348|0.0002
72382135|NCT01178073|144273038|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.477||||0.0004|TWO_SIDED|95.0|0.314|0.723|||Stratified Log Rank||Analysis of time to first adjudicated clinical failure event through FAV. HR is calculated using the Cox proportional hazards model. HR is for Combination Therapy: Ambrisentan + Tadalafil / Ambrisentan Monotherapy.|||0.723|0.314|0.0004
72382136|NCT01178073|144273038|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.528||||0.0045|TWO_SIDED|95.0|0.338|0.827|||Stratified Log Rank||Analysis of time to first adjudicated clinical failure event through FAV. HR is calculated using the Cox proportional hazards model. HR is for Combination Therapy: Ambrisentan + Tadalafil / Tadalafil Monotherapy.|||0.827|0.338|0.0045
72382137|NCT01178073|144273039|SUPERIORITY_OR_OTHER||Mean Percent Difference|-33.81|||<|0.0001|TWO_SIDED|95.0|-44.78|-20.66|||ANCOVA||Mean percent difference is for Combination Therapy: Ambrisentan + Tadalafil - Monotherapy Pooled: Ambrisentan or Tadalafil.|||-20.66|-44.78|<0.0001
72382138|NCT01178073|144273039|SUPERIORITY_OR_OTHER||Mean Percent Difference|-25.09||||0.0111|TWO_SIDED|95.0|-40.04|-6.4|||ANCOVA||Mean percent difference is for Combination Therapy: Ambrisentan + Tadalafil - Ambrisentan Monotherapy.|||-6.40|-40.04|0.0111
72382139|NCT01178073|144273039|SUPERIORITY_OR_OTHER||Mean Percent Difference|-41.51|||<|0.0001|TWO_SIDED|95.0|-53.16|-26.97|||ANCOVA||Mean percent difference is for Combination Therapy: Ambrisentan + Tadalafil - Tadalafil Monotherapy.|||-26.97|-53.16|<0.0001
72382140|NCT01178073|144273040|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.563||||0.0264|TWO_SIDED|95.0|1.054|2.319|||Regression, Logistic||Odds ratio is for Combination Therapy: Ambrisentan + Tadalafil / Monotherapy Pooled: Ambrisentan or Tadalafil.|||2.319|1.054|0.0264
72382141|NCT01178073|144273040|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.424||||0.1518|TWO_SIDED|95.0|0.878|2.308|||Regression, Logistic||Odds ratio is for Combination Therapy: Ambrisentan + Tadalafil / Ambrisentan Monotherapy.|||2.308|0.878|0.1518
72382142|NCT01178073|144273040|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.723||||0.0321|TWO_SIDED|95.0|1.047|2.833|||Regression, Logistic||Odds ratio is for Combination Therapy: Ambrisentan + Tadalafil / Tadalafil Monotherapy.|||2.833|1.047|0.0321
72382143|NCT01178073|144273041|SUPERIORITY_OR_OTHER||Median Difference|22.75|||<|0.0001|TWO_SIDED|95.0|12.0|33.5|||Stratified Wilcoxon Rank Sum Test||Median difference is for Combination Therapy: Ambrisentan + Tadalafil - Monotherapy Pooled: Ambrisentan or Tadalafil.|||33.50|12.00|<0.0001
72382144|NCT01178073|144273041|SUPERIORITY_OR_OTHER||Median Difference|24.75||||0.0005|TWO_SIDED|95.0|11.0|38.5|||Stratified Wilcoxon Rank Sum Test||Median difference is for Combination Therapy: Ambrisentan + Tadalafil - Ambrisentan Monotherapy.|||38.50|11.00|0.0005
72494054|NCT01390909|144517164|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|5681.0|||<|0.0001|TWO_SIDED|95.0|5257.0|6077.0||Adjusted Cost Differences in Hospitalizations, All Medical Costs|Ordinary Least Squares Regression|Ordinary least squares regression was used to adjust differences. Covariates were gender, age, region, comorbidities, baseline treatment, and costs.|Confidence intervals were calculated using a nonparametric bootstrap with 999 replications.|||6077|5257|<0.0001
72557327|NCT03480763|144645377|OTHER|GMT ratio and 95% CI are estimated from a cLDA model.|GMT Ratio|1.11|||||TWO_SIDED|95.0|0.9|1.36||||||Serotype 14 (Shared)||1.36|0.90|
72382145|NCT01178073|144273041|SUPERIORITY_OR_OTHER||Median Difference|20.85||||0.003|TWO_SIDED|95.0|8.0|33.7|||Stratified Wilcoxon Rank Sum Test||Median difference is for Combination Therapy: Ambrisentan + Tadalafil - Tadalafil Monotherapy.|||33.70|8.00|0.0030
72382146|NCT01178073|144273042|SUPERIORITY_OR_OTHER||Median Difference|0.0||||0.2287|TWO_SIDED|95.0|0.0|0.0|||Stratified Wilcoxon Rank Sum Test||Median difference is for Combination Therapy: Ambrisentan + Tadalafil - Monotherapy Pooled: Ambrisentan or Tadalafil.|||0.0|0.0|0.2287
72382147|NCT01178073|144273042|SUPERIORITY_OR_OTHER||Median Difference|0.0|||||TWO_SIDED|95.0|0.0|0.0|||Stratified Wilcoxon Rank Sum Test|This comparison was not formally tested according to the pre-defined hierarchical testing procedure.|Median difference is for Combination Therapy: Ambrisentan + Tadalafil - Ambrisentan Monotherapy.|||0.0|0.0|
72382148|NCT01178073|144273042|SUPERIORITY_OR_OTHER||Median Difference|0.0|||||TWO_SIDED|95.0|0.0|0.0|||Stratified Wilcoxon Rank Sum Test|This comparison was not formally tested according to the pre-defined hierarchical testing procedure.|Median difference is for Combination Therapy: Ambrisentan + Tadalafil - Tadalafil Monotherapy.|||0.0|0.0|
72382149|NCT01178073|144273043|SUPERIORITY_OR_OTHER||Median Difference|-0.38|||||TWO_SIDED|95.0|-0.75|0.0|||Stratified Wilcoxon Rank Sum Test|This endpoint was not formally tested according to the pre-defined hierarchical testing procedure.|Median difference is for Combination Therapy: Ambrisentan + Tadalafil - Monotherapy Pooled: Ambrisentan or Tadalafil.|||0.00|-0.75|
72382150|NCT01178073|144273043|SUPERIORITY_OR_OTHER||Median Difference|-0.5|||||TWO_SIDED|95.0|-1.0|0.0|||Stratified Wilcoxon Rank Sum Test|This endpoint was not formally tested according to the pre-defined hierarchical testing procedure.|Median difference is for Combination Therapy: Ambrisentan + Tadalafil - Ambrisentan Monotherapy.|||0.00|-1.00|
72382151|NCT01178073|144273043|SUPERIORITY_OR_OTHER||Median Difference|-0.5|||||TWO_SIDED|95.0|-1.0|0.0|||Stratified Wilcoxon Rank Sum Test|This endpoint was not formally tested according to the pre-defined hierarchical testing procedure.|Median difference is for Combination Therapy: Ambrisentan + Tadalafil - Tadalafil Monotherapy.|||0.00|-1.00|
72382152|NCT03496571|144273044|SUPERIORITY||LSM Difference from Placebo|-95.0|||<|0.001|TWO_SIDED|95.0|-122.0|-68.0|||ANCOVA|||||-68|-122|<0.001
72382153|NCT03496571|144273044|SUPERIORITY||LSM Difference from Placebo|-102.0|||<|0.001|TWO_SIDED|95.0|-128.0|-76.0|||ANCOVA|||||-76|-128|<0.001
72382154|NCT03496571|144273044|SUPERIORITY||LSM Difference from Placebo|-98.0|||<|0.001|TWO_SIDED|95.0|-121.0|-76.0|||ANCOVA|||||-76|-121|<0.001
72382155|NCT03496571|144273045|SUPERIORITY||Percent Difference from Placebo|55.0|||<|0.001|TWO_SIDED|95.0|27.0|76.0|||Fisher Exact|||||76|27|<0.001
72382156|NCT03496571|144273045|SUPERIORITY||Percent Difference from Placebo|62.0|||<|0.001|TWO_SIDED|95.0|34.0|82.0|||Fisher Exact|||||82|34|<0.001
72382157|NCT03496571|144273045|SUPERIORITY||Percent Difference from Placebo|58.0|||<|0.001|TWO_SIDED|95.0|36.0|74.0|||Fisher Exact|||||74|36|<0.001
72382158|NCT03496571|144273046|SUPERIORITY||LSM Difference from Placebo|-20.0||||0.05|TWO_SIDED|95.0|-40.0|0.0|||ANCOVA|||||0|-40|0.05
72382159|NCT03496571|144273046|SUPERIORITY||LSM Difference from Placebo|-33.0||||0.002|TWO_SIDED|95.0|-53.0|-13.0|||ANCOVA|||||-13|-53|0.002
72382160|NCT03496571|144273046|SUPERIORITY||LSM Difference from Placebo|-26.0||||0.004|TWO_SIDED|95.0|-44.0|-9.0|||ANCOVA|||||-9|-44|0.004
72494055|NCT01390909|144517164|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|273.0|||<|0.0001|TWO_SIDED|95.0|251.0|295.0||Adjusted Cost Differences in Emergency Department Visits, All Medical Costs|Ordinary Least Squares Regression|Ordinary least squares regression was used to adjust differences. Covariates were gender, age, region, comorbidities, baseline treatment, and costs.|Confidence intervals were calculated using a nonparametric bootstrap with 999 replications.|||295|251|<0.0001
72494056|NCT01390909|144517164|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|1021.0|||<|0.0001|TWO_SIDED|95.0|819.0|1211.0||Adjusted Cost Differences in Outpatient Services, All Medical Costs|Ordinary Least Squares Regression|Ordinary least squares regression was used to adjust differences. Covariates were gender, age, region, comorbidities, baseline treatment, and costs.|Confidence intervals were calculated using a nonparametric bootstrap with 999 replications.|||1211|819|<0.0001
72494057|NCT01390909|144517164|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|60.0|||<|0.0001|TWO_SIDED|95.0|48.0|72.0||Adjusted Cost Differences in Neurologist Visits, All Medical Costs|Ordinary Least Squares Regression|Ordinary least squares regression was used to adjust differences. Covariates were gender, age, region, comorbidities, baseline treatment, and costs.|Confidence intervals were calculated using a nonparametric bootstrap with 999 replications.|||72|48|<0.0001
72494058|NCT01390909|144517164|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|2555.0||||0.008|TWO_SIDED|95.0|834.0|4281.0||Adjusted Cost Differences in Other Healthcare Services, All Medical Costs|Ordinary Least Squares Regression|Ordinary least squares regression was used to adjust differences. Covariates were gender, age, region, comorbidities, baseline treatment, and costs.|Confidence intervals were calculated using a nonparametric bootstrap with 999 replications.|||4281|834|0.0080
72494059|NCT01390909|144517164|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4041.0|||<|0.0001|TWO_SIDED|95.0|3776.0|4305.0||Adjusted Cost Differences in Epilepsy-Related Hospitalizations|Ordinary Least Squares Regression|Ordinary least squares regression was used to adjust differences. Covariates were gender, age, region, comorbidities, baseline treatment, and costs.|Confidence intervals were calculated using a nonparametric bootstrap with 999 replications.|||4305|3776|<0.0001
72494060|NCT01390909|144517164|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|105.0|||<|0.0001|TWO_SIDED|95.0|97.0|114.0||Adjusted Cost Differences in Epilepsy-Related Emergency Department Visits|Ordinary Least Squares Regression|Ordinary least squares regression was used to adjust differences. Covariates were gender, age, region, comorbidities, baseline treatment, and costs.|Confidence intervals were calculated using a nonparametric bootstrap with 999 replications.|||114|97|<0.0001
72557328|NCT03480763|144645377|OTHER|GMT ratio and 95% CI are estimated from a cLDA model.|GMT Ratio|1.28|||||TWO_SIDED|95.0|1.05|1.55||||||Serotype 18C (Shared)||1.55|1.05|
72382161|NCT02103218|144273061|SUPERIORITY|||||||0.62|||||||count GEE|||Results from count GEE models for outcome with IPW propensity score adjustment and multiple imputation for missing data. Numbers presented above are model-based least-squares means, (SE). Overall p-values from omnibus test (group by time interaction) for any differences in change over time between groups as well as p-values from testing difference in least-square mean estimates in post-hoc pairwise comparisons with pre-intervention were estimated.||||0.62
72382162|NCT02103218|144273062|SUPERIORITY|||||||0.15|||||||logistic GEE|||Results from logistic GEE models for outcome with IPW propensity score adjustment and multiple imputation for missing data. Numbers presented above are model-based least-squares predicted probabilities converted to %, (SE). Overall p-values from omnibus test (group by time interaction) for any differences in change over time between groups as well as p-values from testing difference in least-square estimates in post-hoc pairwise comparisons with pre-intervention were estimated.||||0.15
72382163|NCT02103218|144273063|SUPERIORITY|||||||0.47|||||||logistic GEE|||Results from logistic GEE models for outcome with IPW propensity score adjustment and multiple imputation for missing data. Numbers presented above are model-based least-squares predicted probabilities converted to %, (SE). Overall p-values from omnibus test (group by time interaction) for any differences in change over time between groups as well as p-values from testing difference in least-square estimates in post-hoc pairwise comparisons with pre-intervention were estimated.||||0.47
72382164|NCT02103218|144273064|SUPERIORITY|||||||0.29|||||||logistic GEE|||Results from logistic GEE models for outcome with IPW propensity score adjustment and multiple imputation for missing data. Numbers presented above are model-based least-squares predicted probabilities converted to %, (SE). Overall p-values from omnibus test (group by time interaction) for any differences in change over time between groups as well as p-values from testing difference in least-square estimates in post-hoc pairwise comparisons with pre-intervention were estimated.||||0.29
72382165|NCT02103218|144273065|SUPERIORITY||||||<|0.001|||||||linear GEE|||Results from linear GEE models for outcome with IPW propensity score adjustment and multiple imputation for missing data. Numbers presented above are model-based least-squares means, (SE). Overall p-values from omnibus test (group by time interaction) for any differences in change over time between groups as well as p-values from testing difference in least-square mean estimates in post-hoc pairwise comparisons with pre-intervention were estimated.||||<0.001
72557329|NCT03480763|144645377|OTHER|GMT ratio and 95% CI are estimated from a cLDA model.|GMT Ratio|1.09|||||TWO_SIDED|95.0|0.91|1.31||||||Serotype 19A (Shared)||1.31|0.91|
72557330|NCT03480763|144645377|OTHER|GMT ratio and 95% CI are estimated from a cLDA model.|GMT Ratio|1.08|||||TWO_SIDED|95.0|0.91|1.29||||||Serotype 19F (Shared)||1.29|0.91|
72557331|NCT03480763|144645377|OTHER|GMT ratio and 95% CI are estimated from a cLDA model.|GMT Ratio|1.37|||||TWO_SIDED|95.0|1.06|1.76||||||Serotype 23F (Shared)||1.76|1.06|
72557332|NCT03480763|144645377|OTHER|GMT ratio and 95% CI are estimated from a cLDA model.|GMT Ratio|12.79|||||TWO_SIDED|95.0|9.44|17.34||||||Serotype 22F (Unique to V114)||17.34|9.44|
72557333|NCT03480763|144645377|OTHER|GMT ratio and 95% CI are estimated from a cLDA model.|GMT Ratio|3.24|||||TWO_SIDED|95.0|2.73|3.84||||||Serotype 33F (Unique to V114)||3.84|2.73|
72618667|NCT01026038|144768107|SUPERIORITY_OR_OTHER||GMC ratio|4.2|||||TWO_SIDED|95.0|2.18|8.09||||||Serotype 5: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||8.09|2.18|
72494061|NCT01390909|144517164|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|384.0|||<|0.0001|TWO_SIDED|95.0|358.0|413.0||Adjusted Cost Differences in Epilepsy-Related Outpatient Services|Ordinary Least Squares Regression|Ordinary least squares regression was used to adjust differences. Covariates were gender, age, region, comorbidities, baseline treatment, and costs.|Confidence intervals were calculated using a nonparametric bootstrap with 999 replications.|||413|358|<0.0001
72494062|NCT01390909|144517164|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|47.0|||<|0.0001|TWO_SIDED|95.0|40.0|56.0||Adjusted Cost Differences in Epilepsy-Related Neurologist Visits|Ordinary Least Squares Regression|Ordinary least squares regression was used to adjust differences. Covariates were gender, age, region, comorbidities, baseline treatment, and costs.|Confidence intervals were calculated using a nonparametric bootstrap with 999 replications.|||56|40|<0.0001
72494063|NCT01390909|144517164|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|892.0|||<|0.0001|TWO_SIDED|95.0|584.0|1192.0||Adjusted Cost Differences in Other Epilepsy-Related Healthcare Costs|Ordinary Least Squares Regression|Ordinary least squares regression was used to adjust differences. Covariates were gender, age, region, comorbidities, baseline treatment, and costs.|Confidence intervals were calculated using a nonparametric bootstrap with 999 replications.|||1192|584|<0.0001
72494064|NCT01390909|144517164|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|12258.0|||<|0.0001|TWO_SIDED|95.0|10482.0|14083.0||Adjusted Cost Differences in Total Healthcare Costs|Ordinary Least Squares Regression|Ordinary least squares regression was used to adjust differences. Covariates were gender, age, region, comorbidities, baseline treatment, and costs.|Confidence intervals were calculated using a nonparametric bootstrap with 999 replications.|||14083|10482|<0.0001
72494065|NCT01390909|144517164|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|322.0|||<|0.0001|TWO_SIDED|95.0|245.0|398.0||Adjusted Cost Differences in Prescription Drug Costs, AEDs|Ordinary Least Squares Regression|Covariates were gender, age, region, comorbidities, AEDs and non-AEDs known to increase seizure risk and baseline costs.||||398|245|<0.0001
72494066|NCT01390909|144517164|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|841.0|||<|0.0001|TWO_SIDED|95.0|556.0|1078.0||Adjusted Cost Differences in Prescription Drug Costs, non-AEDs|Ordinary Least Squares Regression|Covariates were gender, age, region, comorbidities, AEDs and non-AEDs known to increase seizure risk and baseline costs.||||1078|556|<0.0001
72494067|NCT01390909|144517164|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3248.0|||<|0.0001|TWO_SIDED|95.0|2790.0|3714.0||Adjusted Cost Differences in Hospitalizations, All Medical Costs|Ordinary Least Squares Regression|Covariates were gender, age, region, comorbidities, AEDs and non-AEDs known to increase seizure risk and baseline costs.||||3714|2790|<0.0001
72494068|NCT01390909|144517164|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|164.0|||<|0.0001|TWO_SIDED|95.0|138.0|190.0||Adjusted Cost Differences in Emergency Department Visits, All Medical Costs|Ordinary Least Squares Regression|Covariates were gender, age, region, comorbidities, AEDs and non-AEDs known to increase seizure risk and baseline costs.||||190|138|<0.0001
72557334|NCT03480763|144645378|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|0.78|||||TWO_SIDED|95.0|0.65|0.92||||||Serotype 1 (Shared)||0.92|0.65|
72557335|NCT03480763|144645378|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|1.42|||||TWO_SIDED|95.0|1.24|1.63||||||Serotype 3 (Shared)||1.63|1.24|
72557336|NCT03480763|144645378|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|0.77|||||TWO_SIDED|95.0|0.64|0.91||||||Serotype 4 (Shared)||0.91|0.64|
72557337|NCT03480763|144645378|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|0.89|||||TWO_SIDED|95.0|0.75|1.05||||||Serotype 5 (Shared)||1.05|0.75|
72557338|NCT03480763|144645378|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|1.37|||||TWO_SIDED|95.0|1.12|1.67||||||Serotype 6A (Shared)||1.67|1.12|
72557339|NCT03480763|144645378|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|1.48|||||TWO_SIDED|95.0|1.21|1.81||||||Serotype 6B (Shared)||1.81|1.21|
72618668|NCT01026038|144768107|SUPERIORITY_OR_OTHER||GMC ratio|0.61|||||TWO_SIDED|95.0|0.33|1.13||||||Serotype 5: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.13|0.33|
72557340|NCT03480763|144645378|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|0.86|||||TWO_SIDED|95.0|0.72|1.02||||||Serotype 7F (Shared)||1.02|0.72|
72557341|NCT03480763|144645378|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|1.04|||||TWO_SIDED|95.0|0.88|1.23||||||Serotype 9V (Shared)||1.23|0.88|
72557342|NCT03480763|144645378|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|1.05|||||TWO_SIDED|95.0|0.88|1.26||||||Serotype 14 (Shared)||1.26|0.88|
72557343|NCT03480763|144645378|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|1.38|||||TWO_SIDED|95.0|1.17|1.64||||||Serotype 18C (Shared)||1.64|1.17|
72557344|NCT03480763|144645378|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|1.13|||||TWO_SIDED|95.0|0.97|1.33||||||Serotype 19A (Shared)||1.33|0.97|
72557345|NCT03480763|144645378|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|1.13|||||TWO_SIDED|95.0|0.96|1.32||||||Serotype 19F (Shared)||1.32|0.96|
72557346|NCT03480763|144645378|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|1.35|||||TWO_SIDED|95.0|1.12|1.62||||||Serotype 23F (Shared)||1.62|1.12|
72557347|NCT03480763|144645378|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|6.2|||||TWO_SIDED|95.0|5.33|7.21||||||Serotype 22F (Unique to V114)||7.21|5.33|
72434404|NCT02162446|144381976|OTHER|||||||0.469|||||||Wilcoxon signed rank test|||Comparison of 3D-SUV-R of malignant lesions in lymph node with RT as muscle between previous somatostatin receptor scan (ITT population pre-dose) and the 68Ga-OPS202 visit 2 receptor scan (ITT population Day 21) at 1 hour time point.||||0.469
72434405|NCT02162446|144381977|OTHER|||||||0.91|||||||Wilcoxon signed rank test|||Comparison of 3D-SUV-R of malignant lesions in liver with RT as liver between 68Ga-OPS202 visit 1 receptor scan (ITT population Day 0) and 68Ga-OPS202 visit 2 receptor scan (ITT population Day 21) at 1 hour time point.||||0.910
72434406|NCT02162446|144381977|OTHER|||||||0.039|||||||Wilcoxon signed rank test|||Comparison of 3D-SUV-R of malignant lesions in liver with RT as muscle between 68Ga-OPS202 visit 1 receptor scan (ITT population Day 0) and 68Ga-OPS202 visit 2 receptor scan (ITT population Day 21) at 1 hour time point.||||0.039
72434407|NCT02162446|144381977|OTHER|||||||0.375|||||||Wilcoxon signed rank test|||Comparison of 3D-SUV-R of malignant lesions in lymph node with RT as lymph node between 68Ga-OPS202 visit 1 receptor scan (ITT population Day 0) and 68Ga-OPS202 visit 2 receptor scan (ITT population Day 21) at 1 hour time point.||||0.375
72434408|NCT02162446|144381977|OTHER|||||||0.219|||||||Wilcoxon signed rank test|||Comparison of 3D-SUV-R of malignant lesions in lymph node with RT as muscle between 68Ga-OPS202 visit 1 receptor scan (ITT population Day 0) and 68Ga-OPS202 visit 2 receptor scan (ITT population Day 21) at 1 hour time point.||||0.219
72434409|NCT00157014|144382012|SUPERIORITY_OR_OTHER|||||||0.4725||95.0||||No adjustments for multiple comparisons were performed.|Wilcoxon (Mann-Whitney)|||||||0.4725
72434410|NCT00157014|144382023|SUPERIORITY_OR_OTHER|||||||0.8373||95.0||||No adjustments for multiple comparisons were performed.|Wilcoxon (Mann-Whitney)|||||||0.8373
72434411|NCT01362491|144382026|SUPERIORITY_OR_OTHER||Least-Square (LS) mean difference|6.11|||<|0.001|TWO_SIDED|95.0|4.49|7.73||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms.|ANOVA|||Treatment difference (Ibuprofen sodium-placebo) and 95 percent (%) confidence interval (CI): based on LS means from analysis of variance (ANOVA). Type I error was controlled at 0.05 significance level (2-sided) by declaring pair wise comparisons significant only if overall treatment effect among 3 treatment groups was significant and testing in a sequential order Ibuprofen sodium versus (vs.) placebo for SPRID 0-3 then Ibuprofen sodium vs. Ibuprofen (Motrin IB) for time to meaningful relief.||7.73|4.49|<0.001
72434412|NCT01362491|144382027|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.2||||0.253|TWO_SIDED|95.0|0.88|1.65||p-value was calculated using the PH model with treatment, baseline Pain Severity Rating (PSR) and gender terms.|Proportional hazards model|||Hazard Ratio (HR) and corresponding 95% CI were calculated based on the Wald statistic from the proportional hazards (PH) model. Type I error was controlled at 0.05 significance level (2-sided) by declaring pair wise comparisons significant only if overall treatment effect among 3 treatment groups was significant and testing in a sequential order Ibuprofen sodium vs. placebo for SPRID 0-3 then Ibuprofen sodium vs. Ibuprofen (Motrin IB) for time to meaningful relief.||1.65|0.88|0.253
72557348|NCT03480763|144645378|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|5.01|||||TWO_SIDED|95.0|4.38|5.73||||||Serotype 33F (Unique to V114)||5.73|4.38|
72434413|NCT01362491|144382028|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|4.38|||<|0.001|TWO_SIDED|95.0|2.69|7.14||p-value was calculated using the PH model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|Proportional hazards model|||HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model.||7.14|2.69|<0.001
72434414|NCT01362491|144382028|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|3.64|||<|0.001|TWO_SIDED|95.0|2.23|5.94||p-value was calculated using the PH model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|Proportional hazards model|||HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model.||5.94|2.23|<0.001
72434415|NCT01362491|144382029|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|4.68|||<|0.001|TWO_SIDED|95.0|2.87|7.64||p-value was calculated using the PH model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|Proportional hazards model|||HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model.||7.64|2.87|<0.001
72557349|NCT05143801|144645391|EQUIVALENCE|Main effect for environmental conditions.||||||0.003||||||Statistical significance was set at p \< 0.05.|2x2 repeated measures ANOVA|||||||0.003
72557350|NCT05143801|144645391|EQUIVALENCE|Main effect for mask condition.||||||0.933||||||Statistical significance was set at p \< 0.05.|2x2 repeated measures ANOVA|||||||0.933
72434416|NCT01362491|144382029|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|3.88|||<|0.001|TWO_SIDED|95.0|2.38|6.34||p-value was calculated using the PH model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|Proportional hazards model|||HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model.||6.34|2.38|<0.001
72434417|NCT01362491|144382029|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.21||||0.247|TWO_SIDED|95.0|0.88|1.66||p-value was calculated using the PH model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|Proportional hazards model|||HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model.||1.66|0.88|0.247
72434418|NCT01362491|144382030|SUPERIORITY_OR_OTHER||Least Square (LS) mean difference|1.26|||<|0.001|TWO_SIDED|95.0|0.92|1.59||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1 hour: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.59|0.92|<0.001
72557351|NCT05143801|144645391|EQUIVALENCE|Interaction effect across environmental and mask conditions.|No Method of Estimation was used|||||0.344||||||A Bonferroni post-hoc test was used if significant interaction effect was present and p-values were adjusted based on the number of comparisons. To determine if a post-hoc was needed statistical significance was set to p \< 0.05.|2x2 repeated measures ANOVA|||||||0.344
72557352|NCT05143801|144645392|EQUIVALENCE|Main effect for environmental conditions.||||||0.117||||||Statistical significance was set at p \< 0.05.|2x2 Repeated Measures ANOVA|||A 2x2 repeated measures ANOVA was performed to investigate statistical differences for all variables across the four conditions. Both main and interaction effects were calculated along with effect size, reported as partial ⴄ2 as provided by the statistical software JASP (version 0.14.1.0).||||0.117
72434419|NCT01362491|144382030|SUPERIORITY_OR_OTHER||Least Square (LS) mean difference|1.27|||<|0.001|TWO_SIDED|95.0|0.93|1.61||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1 hour: Treatment difference \[Ibuprofen (Motrin IB) - placebo\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.61|0.93|< 0.001
72557353|NCT05143801|144645392|EQUIVALENCE|Main effect for mask condition||||||0.832||||||Statistical significance was set at p \< 0.05.|2x2 Repeated Measures ANOVA|||||||0.832
72557354|NCT05143801|144645392|EQUIVALENCE|Interaction effect across environmental and mask conditions.||||||0.879||||||A Bonferroni post-hoc test was used if significant interaction effect was present and p-values were adjusted based on the number of comparisons. To determine if a post-hoc was needed statistical significance was set to p \< 0.05.|2x2 Repeated Measures ANOVA|||||||0.879
72382166|NCT02103218|144273066|SUPERIORITY|||||||0.02||||||Omnibus overall test for any group x time interaction was p = 0.77.|linear GEE|||Results from linear GEE models for outcome with IPW propensity score adjustment and multiple imputation for missing data. Numbers presented above are model-based least-squares means, (SE). Overall p-values from omnibus test (group by time interaction) for any differences in change over time between groups as well as p-values from testing difference in least-square mean estimates in post-hoc pairwise comparisons with pre-intervention were estimated.||||0.02
72382167|NCT02103218|144273067|SUPERIORITY|||||||0.67|||||||linear GEE|||Results from linear GEE models for outcome with IPW propensity score adjustment and multiple imputation for missing data. Numbers presented above are model-based least-squares means, (SE). Overall p-values from omnibus test (group by time interaction) for any differences in change over time between groups as well as p-values from testing difference in least-square mean estimates in post-hoc pairwise comparisons with pre-intervention were estimated.||||0.67
72382168|NCT02103218|144273068|SUPERIORITY|||||||0.45|||||||count GEE|||Results from count GEE models for outcome with IPW propensity score adjustment and multiple imputation for missing data. Numbers presented above are model-based least-squares means, (SE). Overall p-values from omnibus test (group by time interaction) for any differences in change over time between groups as well as p-values from testing difference in least-square mean estimates in post-hoc pairwise comparisons with pre-intervention were estimated.||||0.45
72382169|NCT02103218|144273069|SUPERIORITY|||||||0.7|||||||count GEE|||Results from count GEE models for outcome with IPW propensity score adjustment and multiple imputation for missing data. Numbers presented above are model-based least-squares means, (SE). Overall p-values from omnibus test (group by time interaction) for any differences in change over time between groups as well as p-values from testing difference in least-square mean estimates in post-hoc pairwise comparisons with pre-intervention were estimated.||||0.70
72382170|NCT02103218|144273070|SUPERIORITY|||||||0.42|||||||linear GEE|||Results from linear GEE models for outcome with IPW propensity score adjustment and multiple imputation for missing data. Numbers presented above are model-based least-squares means, (SE). Overall p-values from omnibus test (group by time interaction) for any differences in change over time between groups as well as p-values from testing difference in least-square mean estimates in post-hoc pairwise comparisons with pre-intervention were estimated.||||0.42
72382171|NCT02103218|144273071|SUPERIORITY|||||||0.63|||||||count GEE|||Results from count GEE models for outcome with IPW propensity score adjustment and multiple imputation for missing data. Numbers presented above are model-based least-squares means, (SE). Overall p-values from omnibus test (group by time interaction) for any differences in change over time between groups as well as p-values from testing difference in least-square mean estimates in post-hoc pairwise comparisons with pre-intervention were estimated.||||0.63
72382172|NCT02103218|144273072|SUPERIORITY|||||||0.05||||||Omnibus overall test for any group x time interaction was p = 0.78.|count GEE|||Results from count GEE models for outcome with IPW propensity score adjustment and multiple imputation for missing data. Numbers presented above are model-based least-squares means, (SE). Overall p-values from omnibus test (group by time interaction) for any differences in change over time between groups as well as p-values from testing difference in least-square mean estimates in post-hoc pairwise comparisons with pre-intervention were estimated.||||0.05
72382173|NCT02103218|144273073|SUPERIORITY|||||||0.5|||||||count GEE|||Results from count GEE models for outcome with IPW propensity score adjustment and multiple imputation for missing data. Numbers presented above are model-based least-squares means, (SE). Overall p-values from omnibus test (group by time interaction) for any differences in change over time between groups as well as p-values from testing difference in least-square mean estimates in post-hoc pairwise comparisons with pre-intervention were estimated.||||0.50
72382174|NCT02103218|144273075|SUPERIORITY|||||||0.86|||||||count GEE|||Results from count GEE models for outcome with IPW propensity score adjustment and multiple imputation for missing data. Numbers presented above are model-based least-squares means, (SE). Overall p-values from omnibus test (group by time interaction) for any differences in change over time between groups as well as p-values from testing difference in least-square mean estimates in post-hoc pairwise comparisons with pre-intervention were estimated.||||0.86
72382175|NCT02103218|144273076|SUPERIORITY|||||||0.46|||||||count GEE|||Results from count GEE models for outcome with IPW propensity score adjustment and multiple imputation for missing data. Numbers presented above are model-based least-squares means, (SE). Overall p-values from omnibus test (group by time interaction) for any differences in change over time between groups as well as p-values from testing difference in least-square mean estimates in post-hoc pairwise comparisons with pre-intervention were estimated.||||0.46
72434420|NCT01362491|144382030|SUPERIORITY_OR_OTHER||Least Square (LS) mean difference|-0.01||||0.943|TWO_SIDED|95.0|-0.29|0.27||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1 hour: Treatment difference \[Ibuprofen sodium - Ibuprofen (Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.27|-0.29|0.943
72557355|NCT05143801|144645393|EQUIVALENCE|Main effect for environmental condition.||||||0.749||||||Statistical significance was set at p \< 0.05|2x2 Repeated Measures ANOVA|||||||0.749
72557356|NCT05143801|144645393|EQUIVALENCE|Main effect for mask condition.||||||0.311||||||Statistical significance was set at p \< 0.05|2x2 Repeated Measures ANOVA|||||||0.311
72618669|NCT01026038|144768107|SUPERIORITY_OR_OTHER||GMC ratio|0.15|||||TWO_SIDED|95.0|0.07|0.31||||||Serotype 5: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||0.31|0.07|
72434421|NCT01362491|144382030|SUPERIORITY_OR_OTHER||Least Square (LS) mean difference|1.25|||<|0.001|TWO_SIDED|95.0|0.89|1.62||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||2 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.62|0.89|<0.001
72557357|NCT05143801|144645393|EQUIVALENCE|Interaction effect across environmental and mask conditions.||||||0.368||||||A Bonferroni post-hoc test was used if significant interaction effect was present and p-values were adjusted based on the number of comparisons. To determine if a post-hoc was needed statistical significance was set to p \< 0.05.|2x2 Repeated Measures ANOVA|||||||0.368
72557358|NCT05143801|144645394|EQUIVALENCE|Main effect for environmental condition.||||||0.789||||||Statistical significance was set at p \< 0.05|2x2 Repeated Measures ANOVA|||||||0.789
72557359|NCT05143801|144645394|EQUIVALENCE|Main effect for mask condition.||||||0.739||||||Statistical significance was set at p \< 0.05|2x2 Repeated Measures ANOVA|||||||0.739
72557360|NCT05143801|144645394|EQUIVALENCE|Interaction effect across environmental and mask conditions.||||||0.158||||||A Bonferroni post-hoc test was used if significant interaction effect was present and p-values were adjusted based on the number of comparisons. To determine if a post-hoc was needed statistical significance was set to p \< 0.05.|2x2 Repeated Measures ANOVA|||||||0.158
72557361|NCT05143801|144645395|EQUIVALENCE|Main effect for environmental condition.||||||0.394||||||Statistical significance was set at p \< 0.05|2x2 Repeated Measures ANOVA|||||||0.394
72557362|NCT05143801|144645395|EQUIVALENCE|Main effect for mask condition||||||0.157||||||Statistical significance was set at p \< 0.05|2x2 Repeated Measures ANOVA|||||||0.157
72557363|NCT05143801|144645395|EQUIVALENCE|Interaction effect across environmental and mask conditions.||||||0.015||||||A Bonferroni post-hoc test was used if significant interaction effect was present and p-values were adjusted based on the number of comparisons. To determine if a post-hoc was needed statistical significance was set to p \< 0.05.|2x2 Repeated Measures ANOVA|||||||0.015
72557364|NCT05143801|144645396|EQUIVALENCE|Main effect for environmental condition.||||||0.96||||||Statistical significance was set at p \< 0.05|2x2 Repeated Measures ANOVA|||||||0.960
72557365|NCT05143801|144645396|EQUIVALENCE|Main effect for mask condition.||||||0.073||||||Statistical significance was set at p \< 0.05|2x2 Repeated Measures ANOVA|||||||0.073
72557366|NCT05143801|144645396|EQUIVALENCE|Interaction effect across environmental and mask conditions.||||||0.503||||||A Bonferroni post-hoc test was used if significant interaction effect was present and p-values were adjusted based on the number of comparisons. To determine if a post-hoc was needed statistical significance was set to p \< 0.05.|2x2 Repeated Measures ANOVA|||||||0.503
72434422|NCT01362491|144382030|SUPERIORITY_OR_OTHER||Least Square (LS) mean difference|1.22|||<|0.001|TWO_SIDED|95.0|0.85|1.59||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||2 hours: Treatment difference \[Ibuprofen (Motrin IB) - placebo\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.59|0.85|<0.001
72557367|NCT05143801|144645397|EQUIVALENCE|Main effect for environmental condition.||||||0.786||||||Statistical significance was set at p \< 0.05|2x2 Repeated Measures ANOVA|||||||0.786
72557368|NCT05143801|144645397|EQUIVALENCE|Main effect for mask condition.||||||0.18||||||Statistical significance was set at p \< 0.05|2x2 Repeated Measures ANOVA|||||||0.180
72557369|NCT05143801|144645397|EQUIVALENCE|Interaction effect across environmental and mask conditions.||||||0.239||||||A Bonferroni post-hoc test was used if significant interaction effect was present and p-values were adjusted based on the number of comparisons. To determine if a post-hoc was needed statistical significance was set to p \< 0.05.|2x2 Repeated Measures ANOVA|||||||0.239
72557370|NCT05143801|144645398|EQUIVALENCE|Main effect for environmental condition.||||||0.134||||||Statistical significance was set at p \< 0.05|2x2 Repeated Measures ANOVA|||||||0.134
72557371|NCT05143801|144645398|EQUIVALENCE|Main effect for mask condition.||||||0.621||||||Statistical significance was set at p \< 0.05|2x2 Repeated Measures ANOVA|||||||0.621
72557372|NCT05143801|144645398|EQUIVALENCE|Interaction effect across environmental and mask conditions.||||||0.553||||||A Bonferroni post-hoc test was used if significant interaction effect was present and p-values were adjusted based on the number of comparisons. To determine if a post-hoc was needed statistical significance was set to p \< 0.05.|2x2 Repeated Measures ANOVA|||||||0.553
72557373|NCT05143801|144645399|EQUIVALENCE|Main effect for environmental condition.||||||0.461||||||Statistical significance was set at p \< 0.05|2x2 Repeated Measures ANOVA|||||||0.461
72557374|NCT05143801|144645399|EQUIVALENCE|Main effect for mask condition.||||||0.877||||||Statistical significance was set at p \< 0.05|2x2 Repeated Measures ANOVA|||||||0.877
72434423|NCT01362491|144382030|SUPERIORITY_OR_OTHER||Least Square (LS) mean difference|0.03||||0.847|TWO_SIDED|95.0|-0.27|0.33||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||2 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.33|-0.27|0.847
72434424|NCT01362491|144382030|SUPERIORITY_OR_OTHER||Least Square (LS) mean difference|1.59|||<|0.001|TWO_SIDED|95.0|1.14|2.05||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||3 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||2.05|1.14|<0.001
72557375|NCT05143801|144645399|EQUIVALENCE|Interaction effect across environmental and mask conditions.||||||0.919||||||A Bonferroni post-hoc test was used if significant interaction effect was present and p-values were adjusted based on the number of comparisons. To determine if a post-hoc was needed statistical significance was set to p \< 0.05.|2x2 Repeated Measures ANOVA|||||||0.919
72557376|NCT05143801|144645400|EQUIVALENCE|Main effect for environmental condition.||||||0.466||||||Statistical significance was set at p \< 0.05|2x2 Repeated Measures ANOVA|||||||0.466
72557377|NCT05143801|144645400|EQUIVALENCE|Main effect for mask condition.||||||0.186||||||Statistical significance was set at p \< 0.05|2x2 Repeated Measures ANOVA|||||||0.186
72557378|NCT05143801|144645400|EQUIVALENCE|Interaction effect across environmental and mask conditions.||||||0.08||||||A Bonferroni post-hoc test was used if significant interaction effect was present and p-values were adjusted based on the number of comparisons. To determine if a post-hoc was needed statistical significance was set to p \< 0.05.|2x2 Repeated Measures ANOVA|||||||0.080
72557379|NCT05143801|144645401|EQUIVALENCE|Main effect for environmental condition.||||||0.375||||||Statistical significance was set at p \< 0.05|2x2 Repeated Measures ANOVA|||||||0.375
72618670|NCT01026038|144768107|SUPERIORITY_OR_OTHER||GMC ratio|3.11|||||TWO_SIDED|95.0|1.51|6.4||||||Serotype 6A: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||6.40|1.51|
72382176|NCT02103218|144273077|SUPERIORITY|||||||0.7|||||||linear GEE|||Results from linear GEE models for outcome with IPW propensity score adjustment and multiple imputation for missing data. Numbers presented above are model-based least-squares means, (SE). Overall p-values from omnibus test (group by time interaction) for any differences in change over time between groups as well as p-values from testing difference in least-square mean estimates in post-hoc pairwise comparisons with pre-intervention were estimated.||||0.70
72382177|NCT02103218|144273078|SUPERIORITY|||||||0.29|||||||linear GEE|||Results from linear GEE models for outcome with IPW propensity score adjustment and multiple imputation for missing data. Numbers presented above are model-based least-squares means, (SE). Overall p-values from omnibus test (group by time interaction) for any differences in change over time between groups as well as p-values from testing difference in least-square mean estimates in post-hoc pairwise comparisons with pre-intervention were estimated.||||0.29
72382178|NCT02103218|144273079|SUPERIORITY|||||||0.43|||||||linear GEE|||Results from linear GEE models for outcome with IPW propensity score adjustment and multiple imputation for missing data. Numbers presented above are model-based least-squares means, (SE). Overall p-values from omnibus test (group by time interaction) for any differences in change over time between groups as well as p-values from testing difference in least-square mean estimates in post-hoc pairwise comparisons with pre-intervention were estimated.||||0.43
72382179|NCT00644228|144273088|SUPERIORITY||Hazard Ratio (HR)|0.712||||0.0018|TWO_SIDED|96.0|0.56|0.906||The p-value is from a one-sided, stratified log-rank test. Stratification factors include those factors by which patients were randomized: intent to transplant (yes vs no) and ISS Stage (I vs II vs III).|Log Rank||The hazard ratio compares Bortezomib/Lenalidomide/Dexamethasone against Lenalidomide/Dexamethasone.|With four years of patient accrual and two and a half years of follow-up, 220 patients per arm yields 87% power to detect an increase of PFS of 50%, from a median of 3 years to 4.5 years, which corresponds to a hazard ratio of 1.5. These calculations are based on a one-sided stratified log-rank test at level 0.025 with two interim analyses. The final analysis will be carried out at the 0.02 significance level to allow for two interim analyses at the 0.0025 significance level.||0.906|0.560|0.0018
72382180|NCT00644228|144273089|SUPERIORITY||Hazard Ratio (HR)|0.709||||0.025|TWO_SIDED|95.0|0.524|0.959||The p-value is based on a two-sided, stratified log rank test. Stratification factors include those factors by which patients were randomized: intent to transplant (yes vs no) and ISS Stage (I vs II vs III).|Log Rank||The hazard ratio compares Bortezomib/Lenalidomide/Dexamethasone against Lenalidomide/Dexamethasone.|Overall survival will be compared between the two treatment arms using a stratified log-rank test.||0.959|0.524|0.0250
72382181|NCT00644228|144273090|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2||||||The p-value is based on a stratified Cochran-Mantel-Haenszel test. Stratification factors include those factors by which patients were randomized: intent to transplant (yes vs no) and ISS Stage (I vs II vs III).|Cochran-Mantel-Haenszel|||||||0.20
72382182|NCT02567552|144273092|OTHER|||||||0.3395|||||||Chi-squared|||||||0.3395
72382183|NCT02567552|144273093|OTHER|||||||0.1523|||||||Chi-squared|||||||0.1523
72382184|NCT02567552|144273094|OTHER|||||||0.1189|||||||t-test, 2 sided|||comparison between groups||||0.1189
72382185|NCT02567552|144273096|OTHER|||||||0.2042|||||||t-test, 2 sided|||||||0.2042
72382186|NCT02567552|144273097|OTHER|||||||0.6262|||||||t-test, 2 sided|||||||0.6262
72382187|NCT02567552|144273098|OTHER|||||||0.2301|||||||t-test, 2 sided|||||||0.2301
72382188|NCT02567552|144273099|OTHER|||||||0.5118|||||||t-test, 2 sided|||||||0.5118
72382189|NCT02567552|144273100|OTHER|||||||0.8371|||||||t-test, 2 sided|||||||0.8371
72382190|NCT02567552|144273101|OTHER||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
72382191|NCT02567552|144273102|OTHER|||||||0.3107|||||||t-test, 2 sided|||||||0.3107
72382192|NCT02567552|144273103|OTHER|||||||0.5|||||||Fisher Exact|||||||0.5
72382193|NCT03635788|144273112|SUPERIORITY|The study had approximately 80% power to show superiority of the LA ART compared to daily SOC with respect to the Step 2, week 48, cumulative probability of regimen failure|Cumulative probability difference|-18.4|||||TWO_SIDED|98.4|-32.4|-4.3|||||Treatment difference was calculated as LA-ART minus SOC. 98.4% is nominal confidence interval.|Treatment comparison was conducted by cumulative probability of regimen failure in Step 2 up to Step 2 Week 48 visit by treatment arm. The treatment difference was assessed using the 95% repeated confidence interval adjusted for interim efficacy analyses, i.e., a nominal 98.4% confidence interval.||-4.3|-32.4|
72434425|NCT01362491|144382030|SUPERIORITY_OR_OTHER||Least Square (LS) mean difference|1.68|||<|0.001|TWO_SIDED|95.0|1.22|2.13||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||3 hours: Treatment difference \[Ibuprofen (Motrin IB) - placebo\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||2.13|1.22|<0.001
72557380|NCT05143801|144645401|EQUIVALENCE|Main effect for mask condition.||||||0.178||||||Statistical significance was set at p \< 0.05|2x2 Repeated Measures ANOVA|||||||0.178
72382194|NCT03635788|144273113|SUPERIORITY|The study had at least 80% power to show superiority of the LA ART compared to daily SOC with respect to the Step 2, week 48, cumulative probability of virologic failure|cumulative probability difference|-21.4|||||TWO_SIDED|98.4|-33.5|-9.3|||||Treatment difference was calculated as LA-ART minus SOC.98.4% is nominal confidence interval.|Treatment comparison was conducted by cumulative probability of virologic failure in Step 2 up to Step 2 Week 48 visit by treatment arm. The treatment difference was assessed using the 95% repeated confidence interval adjusted for interim efficacy analyses, i.e., a nominal 98.4% confidence interval.||-9.3|-33.5|
72557381|NCT05143801|144645401|EQUIVALENCE|Interaction effect across environmental and mask conditions.||||||0.533||||||A Bonferroni post-hoc test was used if significant interaction effect was present and p-values were adjusted based on the number of comparisons. To determine if a post-hoc was needed statistical significance was set to p \< 0.05.|2x2 Repeated Measures ANOVA|||||||0.533
72557382|NCT05143801|144645402|EQUIVALENCE|Main effect for environmental condition.||||||0.29||||||Statistical significance was set at p \< 0.05|2x2 Repeated Measures ANOVA|||||||0.290
72557383|NCT05143801|144645402|EQUIVALENCE|Main effect for mask condition.||||||0.527||||||Statistical significance was set at p \< 0.05|2x2 Repeated Measures ANOVA|||||||0.527
72494069|NCT01390909|144517164|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|628.0|||<|0.0001|TWO_SIDED|95.0|409.0|819.0||Adjusted Cost Differences in Outpatient Services, All Medical Costs|Ordinary Least Squares Regression|Covariates were gender, age, region, comorbidities, AEDs and non-AEDs known to increase seizure risk and baseline costs.||||819|409|<0.0001
72382195|NCT03635788|144273114|SUPERIORITY||cumulative probability diffeence|-19.2|||||TWO_SIDED|98.4|-31.6|-6.9||||||Treatment comparison was conducted by cumulative probability of treatment-related failure in Step 2 up to Step 2 Week 48 visit by treatment arm. The treatment difference was assessed using the 95% repeated confidence interval adjusted for interim efficacy analyses, i.e., a nominal 98.4% confidence interval.|Treatment difference was calculated as LA-ART minus SOC.98.4% is nominal confidence interval.|-6.9|-31.6|
72382196|NCT03635788|144273115|SUPERIORITY|The proportions of participants with HIV-1 RNA ≥ 50 copies/ml was compared by Fisher's Exact Test.|Mean Difference (Final Values)|-21.8|||<|0.001|TWO_SIDED|95.0|-35.6|-8.1|||Fisher Exact||||Treatment difference in the proportions of participants with HIV-1 RNA ≥ 50 copies/ml was calculated as LA-ART minus SOC.|-8.1|-35.6|<0.001
72382197|NCT03635788|144273116|SUPERIORITY||Mean Difference (Final Values)|-24.5|||<|0.001|TWO_SIDED|95.0|-36.1|-12.8|||Fisher Exact||Difference in the proportions of participants with HIV-1 RNA ≥ 200 copies was calculated as LA-ART minus SOC.|The proportions of participants with HIV-1 RNA ≥ 200 copies/ml was compared by Fisher's Exact Test.||-12.8|-36.1|<0.001
72382198|NCT03635788|144273121|SUPERIORITY||Cumulative probability difference|-8.4|||||TWO_SIDED|98.4|-21.3|4.5|||||Treatment difference in cumulative of permanent treatment discontinuation was calculated as LA-ART minus SOC.98.4% is nominal confidence interval.|Treatment comparison was conducted by cumulative probability of permanent treatment discontinuation in Step 2 up to Step 2 Week 48 visit by treatment arm. The treatment difference was assessed using the 95% repeated confidence interval adjusted for interim efficacy analyses, i.e., a nominal 98.4% confidence interval.||4.5|-21.3|
72382199|NCT03811002|144273163|SUPERIORITY||Hazard Ratio (HR)|1.05||||0.5819|TWO_SIDED|95.0|0.82|1.34|||Log Rank|Stratified by radiation schedule (BID vs daily), chemotherapy (cisplatin vs carboplatin), and sex (male vs female). 1-sided significance level 0.025.|Stratified by radiation schedule (BID vs daily), chemotherapy (cisplatin vs carboplatin), and sex (male vs female). Reference level = Arm 1.|Assuming exponentially distributed survival times, 480 eligible patients accrued uniformly over 48 months months) with 26 months additional follow-up after the last accrued patient would provide at least 85% power to detect a hazard ratio of 0.71 (median survival times of 38 months \[Arm I\] vs. 27 months \[Arm II\]) at a one-sided significance level of 0.025, after adjusting for type 1 error using group sequential methods for two interim analyses.||1.34|0.82|0.5819
72382200|NCT03811002|144273164|SUPERIORITY||Hazard Ratio (HR)|0.98|||||TWO_SIDED|95.0|0.8|1.21|||Log Rank||Stratified by radiation schedule (BID vs daily), chemotherapy (cisplatin vs carboplatin), and sex (male vs female). Reference level = Arm 1.|||1.21|0.80|
72382201|NCT03811002|144273167|SUPERIORITY||Hazard Ratio (HR)|0.86|||||TWO_SIDED|95.0|0.52|1.41|||||Cause-specific hazard ratio stratified by radiation schedule (BID vs daily), chemotherapy (cisplatin vs carboplatin), and sex (male vs female). Reference level = Arm 1.|||1.41|0.52|
72382202|NCT03811002|144273168|SUPERIORITY||Hazard Ratio (HR)|0.95|||||TWO_SIDED|95.0|0.76|1.2|||||Stratified by radiation schedule (BID vs daily), chemotherapy (cisplatin vs carboplatin), and sex (male vs female). Reference level = Arm I.|||1.20|0.76|
72382203|NCT04191187|144273178|SUPERIORITY||PFS at 18 Months|70.8||||0.002|ONE_SIDED|90.0|59.2|||One sided log rank test|Log Rank||||||59.2|0.002
72382204|NCT02160782|144273184|EQUIVALENCE|The P-value for testing if the treatment group least squares (LS) means were equal was calculated to determine if the change in sBA levels between the treatment groups was statistically significant.|Mean Difference (Net)|-117.28|STANDARD_ERROR_OF_MEAN|52.828||0.0464|TWO_SIDED|95.0|-232.38|-2.18|||ANCOVA|||The difference between treatment groups in change from Week 18 to Week 22 in fasting sBA levels was evaluated using an analysis of covariance (ANCOVA) model with treatment group as a factor, and Week 18 sBA as a covariate. The analysis used a tabulation of fitted summary statistics from ANCOVA in the MITT population, which included all participants who were enrolled, received study drug through Week 18, and had a reduction from baseline in sBA of ≥50% at the Week 12 or Week 18 measurement.||-2.18|-232.38|0.0464
72382205|NCT02160782|144273185|EQUIVALENCE|The null hypothesis that the mean change was equal to zero was tested using the Student's t-test to determine if the mean change in sBA levels between baseline and Week 18 (the open-label period) was statistically significant.|Mean Difference (Net)|-87.73|STANDARD_DEVIATION|119.979||0.0005|TWO_SIDED|95.0|-133.37|-42.09||Data for this analysis were obtained from 31 participants at baseline; 29 of those participants contributed Week 18 data.|Student's t-test|||This analysis investigated whether a statistically significant change in sBA levels was observed when comparing baseline to Week 18 (the open-label period, during which all participants received MRX). The analysis was based on the ITT population.||-42.09|-133.37|0.0005
72382206|NCT02160782|144273186|EQUIVALENCE|The null hypothesis that the mean change was equal to zero was tested using the Student's t-test to determine if the mean change in ItchRO(Obs) scores between baseline and Week 18 (the open-label period) was statistically significant.|Mean Difference (Net)|-1.704|STANDARD_DEVIATION|0.9114|<|0.0001|TWO_SIDED|95.0|-2.051|-1.357|||Student's t-test|||This analysis investigated whether a statistically significant change in ItchRO(Obs) score was observed when comparing baseline to Week 18 (the open-label period, during which all participants received MRX). The analysis was based on the ITT population. ItchRO scores range from 0 to 4; the higher score indicates increasing itch severity.||-1.357|-2.051|< 0.0001
72618671|NCT01026038|144768107|SUPERIORITY_OR_OTHER||GMC ratio|1.88|||||TWO_SIDED|95.0|0.96|3.69||||||Serotype 6A: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||3.69|0.96|
72618672|NCT01026038|144768107|SUPERIORITY_OR_OTHER||GMC ratio|0.6|||||TWO_SIDED|95.0|0.27|1.37||||||Serotype 6A: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.37|0.27|
72618673|NCT01026038|144768107|SUPERIORITY_OR_OTHER||GMC ratio|2.88|||||TWO_SIDED|95.0|1.39|5.98||||||Serotype 7F: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||5.98|1.39|
72382207|NCT02160782|144273187|EQUIVALENCE|The null hypothesis that the mean change was equal to zero was tested using the Student's t-test to determine if the mean change in ItchRO(Pt) scores between baseline and Week 18 (the open-label period) was statistically significant.|Mean Difference (Net)|-2.072|STANDARD_DEVIATION|0.9931|<|0.0001|TWO_SIDED|95.0|-2.645|-1.498|||Student's t-test|||This analysis investigated whether a statistically significant change in ItchRO(Pt) score was observed when comparing baseline to Week 18 (the open-label period, during which all participants received MRX). The analysis was based on the ITT population. ItchRO scores range from 0 to 4; the higher score indicates increasing itch severity.||-1.498|-2.645|< 0.0001
72382208|NCT02160782|144273188|EQUIVALENCE|The P-value for testing if the treatment group LS means were equal was calculated to determine if the change in ItchRO(Obs) between the treatment groups was statistically significant.|Mean Difference (Net)|-1.483|STANDARD_ERROR_OF_MEAN|0.3103|<|0.0001|TWO_SIDED|95.0|-2.122|-0.844|||ANCOVA|||The difference between treatment groups in change from Week 18 to Week 22 in ItchRO(Obs) was evaluated using an ANCOVA model with treatment group as a factor, and Week 18 ItchRO(Obs) as a covariate. The analysis used a tabulation of fitted summary statistics from ANCOVA in the intent-to-treat population, which included all participants who were enrolled, and received at least one dose of study drug.||-0.844|-2.122|< 0.0001
72382209|NCT02160782|144273189|EQUIVALENCE|The P-value for testing if the treatment group LS means were equal was calculated to determine if the change in ItchRO(Pt) between the treatment groups was statistically significant. While the number of participants included in analysis for the end point indicates 28, there were only 14; n = 5 for ItchRO(Pt): MRX and n = 9 for ItchRO(Pt): placebo.|Mean Difference (Net)|-1.988|STANDARD_ERROR_OF_MEAN|0.4641||0.0013|TWO_SIDED|95.0|-3.009|-0.967|||ANCOVA|||The difference between treatment groups in change from Week 18 to Week 22 in ItchRO (Pt) was evaluated using an ANCOVA model with treatment group as a factor, and Week 18 ItchRO(Pt) as a covariate. The analysis used a tabulation of fitted summary statistics from ANCOVA in the intent-to-treat population, which included all participants who were enrolled, and received at least one dose of study drug.||-0.967|-3.009|0.0013
72382210|NCT02160782|144273190|EQUIVALENCE|The null hypothesis that the mean change was equal to zero was tested using the Student's t-test to determine if the mean change in ALP levels between baseline and Week 18 (the open-label period) was statistically significant.|Mean Difference (Net)|-27.8|STANDARD_DEVIATION|118.33||0.2163|TWO_SIDED|95.0|-72.8|17.2||Data for this analysis were obtained from 31 participants at baseline; 29 of those participants contributed Week 18 data.|Student's t-test|||This analysis investigated whether a statistically significant change in ALP levels was observed when comparing baseline to Week 18 (the open-label period, during which all participants received MRX). The analysis was based on the ITT population.||17.2|-72.8|0.2163
72382211|NCT02160782|144273191|EQUIVALENCE|The P-value for testing if the treatment group LS means were equal was calculated to determine if the change in ALP levels between the treatment groups was statistically significant.|Mean Difference (Net)|10.0|STANDARD_ERROR_OF_MEAN|30.44||0.7455|TWO_SIDED|95.0|-52.6|72.6|||ANCOVA|||The difference between treatment groups in change from Week 18 to Week 22 in ALP levels was evaluated using an ANCOVA model with treatment group as a factor, and Week 18 ALP as a covariate. The analysis used a tabulation of fitted summary statistics from ANCOVA in the intent-to-treat population, which included all participants who were enrolled, and received at least one dose of study drug.||72.6|-52.6|0.7455
72382212|NCT02160782|144273192|EQUIVALENCE|The null hypothesis that the mean change was equal to zero was tested using the Student's t-test to determine if the mean change in ALT levels between baseline and Week 18 (the open-label period) was statistically significant.|Mean Difference (Net)|-1.3|STANDARD_DEVIATION|84.54||0.9358|TWO_SIDED|95.0|-33.4|30.9||Data for this analysis were obtained from 31 participants at baseline; 29 of those participants contributed Week 18 data.|Student's t-test|||This analysis investigated whether a statistically significant change in ALT levels was observed when comparing baseline to Week 18 (the open-label period, during which all participants received MRX). The analysis was based on the ITT population.||30.9|-33.4|0.9358
72382213|NCT02160782|144273193|EQUIVALENCE|The P-value for testing if the treatment group LS means were equal was calculated to determine if the change in ALT levels between the treatment groups was statistically significant.|Mean Difference (Net)|15.1|STANDARD_ERROR_OF_MEAN|19.53||0.4472|TWO_SIDED|95.0|-25.1|55.2|||ANCOVA|||The difference between treatment groups in change from Week 18 to Week 22 in ALT levels was evaluated using an ANCOVA model with treatment group as a factor, and Week 18 ALT as a covariate. The analysis used a tabulation of fitted summary statistics from ANCOVA in the intent-to-treat population, which included all participants who were enrolled, and received at least one dose of study drug.||55.2|-25.1|0.4472
72382214|NCT02160782|144273194|EQUIVALENCE|The null hypothesis that the mean change was equal to zero was tested using the Student's t-test to determine if the mean change in total bilirubin levels between baseline and Week 18 (the open-label period) was statistically significant.|Mean Difference (Net)|-0.47|STANDARD_DEVIATION|1.424||0.0893|TWO_SIDED|95.0|-1.01|0.08|||Student's t-test|||||0.08|-1.01|0.0893
72382215|NCT02160782|144273195|EQUIVALENCE|The P-value for testing if the treatment group LS means were equal was calculated to determine if the change in total bilirubin between the treatment groups was statistically significant.|Mean Difference (Net)|-0.14|STANDARD_ERROR_OF_MEAN|0.361||0.7|TWO_SIDED|95.0|-0.88|0.6|||ANCOVA|||The difference between treatment groups in change from Week 18 to Week 22 in total bilirubin was evaluated using an ANCOVA model with treatment group as a factor, and Week 18 total bilirubin as a covariate. The analysis used a tabulation of fitted summary statistics from ANCOVA in the intent-to-treat population, which included all participants who were enrolled, and received at least one dose of study drug.||0.6|-0.88|0.7
72382216|NCT02160782|144273196|EQUIVALENCE|The null hypothesis that the mean change was equal to zero was tested using the Student's t-test to determine if the mean change in direct bilirubin levels between baseline and Week 18 (the open-label period) was statistically significant.|Mean Difference (Net)|-0.5|STANDARD_DEVIATION|1.012||0.0139|TWO_SIDED|95.0|-0.9|-0.11|||Student's t-test|||||-0.11|-0.9|0.0139
72434426|NCT01362491|144382030|SUPERIORITY_OR_OTHER||Least Square (LS) mean difference|-0.08||||0.663|TWO_SIDED|95.0|-0.46|0.29||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||3 hours: Treatment difference \[Ibuprofen sodium - (Ibuprofen IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.29|-0.46|0.663
72382217|NCT02160782|144273197|EQUIVALENCE|The P-value for testing if the treatment group LS means were equal was calculated to determine if the change in direct bilirubin between the treatment groups was statistically significant.|Mean Difference (Net)|-0.02|STANDARD_ERROR_OF_MEAN|0.265||0.9517|TWO_SIDED|95.0|-0.56|0.53|||ANCOVA|||The difference between treatment groups in change from Week 18 to Week 22 in direct bilirubin levels was evaluated using an ANCOVA model with treatment group as a factor, and Week 18 direct bilirubin as a covariate. The analysis used a tabulation of fitted summary statistics from ANCOVA in the intent-to-treat population, which included all participants who were enrolled, and received at least one dose of study drug.||0.53|-0.56|0.9517
72382218|NCT03437512|144273212|SUPERIORITY||||||<|0.001||||||familywise error rate (FWE) corrected to .05 with cluster threshold of 80 voxels.|t-test, 2 sided|||||||<.001
72382219|NCT03437512|144273213|SUPERIORITY|||||||0.936||||||Interaction between visit and group.|ANOVA|||Analyses conduced with a mixed ANOVA, with between-subjects factor of group (active, sham) and two within-subjects factors: time (post, follow up) and speech task (reading, conversation).||||.936
72382220|NCT03437512|144273214|SUPERIORITY|||||||0.619||||||Interaction between visit and group.|ANOVA|||||||.619
72382221|NCT00674973|144273218|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.83||||0.1909|TWO_SIDED|95.0|0.63|1.1|||Log Rank|||Cox proportional hazards model was used to estimate the Hazard Ratio (erlotinib compared with placebo), including 95 percent (%) confidence intervals (CIs).||1.10|0.63|0.1909
72382222|NCT00763048|144273223|SUPERIORITY_OR_OTHER||||||<|0.05|ONE_SIDED|95.0|||||t-test, 1 sided|||The null hypothesis states that there is no difference between groups.||||<0.05
72382223|NCT00763048|144273224|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||t-test, 1 sided|||The null hypothesis states that there is no difference between groups.||||<0.05
72382224|NCT00763048|144273225|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||t-test, 1 sided|||The null hypothesis states that there is no difference between groups.||||<0.05
72382225|NCT00763048|144273226|SUPERIORITY_OR_OTHER|||||||0.05|ONE_SIDED|95.0|||||t-test, 1 sided|||The null hypothesis states that there is no difference between groups.||||0.05
72382226|NCT00763048|144273227|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||t-test, 1 sided|||The null hypothesis states that there is no difference between groups.||||0.05
72382227|NCT00763048|144273228|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||t-test, 1 sided|||The null hypothesis states that there is no difference between groups.||||0.05
72382228|NCT00763048|144273229|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||t-test, 1 sided|||The null hypothesis states that there is no difference between groups.||||0.05
72382229|NCT00763048|144273230|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||t-test, 1 sided|||The null hypothesis states that there is no difference between groups.||||0.05
72382230|NCT00763048|144273231|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||t-test, 1 sided|||The null hypothesis states that there is no difference between groups.||||0.05
72382231|NCT02247531|144273263|SUPERIORITY||Difference in Adjusted Means|0.157||||0.0479|TWO_SIDED|95.0|0.001|0.313|||MMRM|||Week 48: MMRM analysis uses change as response variable and included treatment group, visit, treatment-by-visit interaction, baseline GA area, lesion location, contiguity, biomarker status, modified baseline BCVA and sex.||0.313|0.001|0.0479
72382232|NCT02247531|144273263|SUPERIORITY||Difference in Adjusted Means|0.087||||0.2739|TWO_SIDED|95.0|-0.069|0.243|||MMRM|||Week 48: MMRM analysis uses change as response variable and included treatment group, visit, treatment-by-visit interaction, baseline GA area, lesion location, contiguity, biomarker status, modified baseline BCVA and sex.||0.243|-0.069|0.2739
72434427|NCT01362491|144382031|SUPERIORITY_OR_OTHER||Least Square (LS) mean difference|0.54|||<|0.001|TWO_SIDED|95.0|0.37|0.72||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1 hour: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.72|0.37|<0.001
72382233|NCT02247531|144273264|SUPERIORITY||Difference in Adjusted Means|-0.4||||0.84|TWO_SIDED|95.0|-4.8|3.9|||MMRM|||Week 48: MMRM analysis uses change as response variable and included treatment group, visit, treatment-by-visit interaction, baseline number of absolute scotomatous points, GA lesion location, contiguity, biomarker status, modified baseline BCVA and sex.||3.9|-4.8|0.8400
72382234|NCT02247531|144273264|SUPERIORITY||Difference in Adjusted Means|1.3||||0.5587|TWO_SIDED|95.0|-3.1|5.7|||MMRM|||Week 48: MMRM analysis uses change as response variable and included treatment group, visit, treatment-by-visit interaction, baseline number of absolute scotomatous points, GA lesion location, contiguity, biomarker status, modified baseline BCVA and sex.||5.7|-3.1|0.5587
72382235|NCT02247531|144273265|SUPERIORITY||Difference in Adjusted Means|0.1||||0.8358|TWO_SIDED|95.0|-0.88|1.09|||MMRM|||Week 48: MMRM analysis uses change as response variable and included treatment group, visit, treatment-by-visit interaction, baseline mean macular sensitivity, GA lesion location, contiguity, biomarker status, modified baseline BCVA and sex.||1.09|-0.88|0.8358
72382236|NCT02247531|144273265|SUPERIORITY||Difference in Adjusted Means|-0.26||||0.6117|TWO_SIDED|95.0|-1.25|0.74|||MMRM|||Week 48: MMRM analysis uses change as response variable and included treatment group, visit, treatment-by-visit interaction, baseline mean macular sensitivity, GA lesion location, contiguity, biomarker status, modified baseline BCVA and sex.||0.74|-1.25|0.6117
72382237|NCT02247531|144273266|SUPERIORITY||Difference in Adjusted Means|0.7||||0.4651|TWO_SIDED|95.0|-1.2|2.5|||MMRM|||Week 48: MMRM analysis uses change as response variable and included treatment group, visit, treatment-by-visit interaction, baseline BCVA, GA lesion location, biomarker status, and sex.||2.5|-1.2|0.4651
72382238|NCT02247531|144273266|SUPERIORITY||Difference in Adjusted Means|0.3||||0.7885|TWO_SIDED|95.0|-1.6|2.1|||MMRM|||Week 48: MMRM analysis uses change as response variable and included treatment group, visit, treatment-by-visit interaction, baseline BCVA, GA lesion location, biomarker status, and sex.||2.1|-1.6|0.7885
72382239|NCT02247531|144273267|SUPERIORITY||Odds Ratio (OR)|1.1||||0.6892|TWO_SIDED|95.0|0.7|1.8|||Regression, Logistic|||||1.8|0.7|0.6892
72382240|NCT02247531|144273267|SUPERIORITY||Odds Ratio (OR)|1.0||||0.9104|TWO_SIDED|95.0|0.6|1.6|||Regression, Logistic|||||1.6|0.6|0.9104
72382241|NCT02247531|144273268|SUPERIORITY||Difference in Adjusted Means|-0.1||||0.8931|TWO_SIDED|95.0|-1.8|1.5|||MMRM|||Week 48: MMRM analysis uses change as response variable and included treatment group, visit, treatment-by-visit interaction, baseline LLVA, GA lesion location, biomarker status, modified baseline BCVA ETDRS chart Snellen equivalent category, and sex.||1.5|-1.8|0.8931
72434428|NCT01362491|144382031|SUPERIORITY_OR_OTHER||Least Square (LS) mean difference|0.51|||<|0.001|TWO_SIDED|95.0|0.33|0.69||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1 hour: Treatment difference \[Ibuprofen (Motrin IB) - placebo\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.69|0.33|<0.001
72434429|NCT01362491|144382031|SUPERIORITY_OR_OTHER||Least Square (LS) mean difference|0.03||||0.651|TWO_SIDED|95.0|-0.11|0.18||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1 hour: Treatment difference \[Ibuprofen sodium - Ibuprofen (Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.18|-0.11|0.651
72434430|NCT01362491|144382031|SUPERIORITY_OR_OTHER||Least Square (LS) mean difference|0.62|||<|0.001|TWO_SIDED|95.0|0.42|0.81||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||2 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.81|0.42|<0.001
72434431|NCT01362491|144382031|SUPERIORITY_OR_OTHER||Least Square (LS) mean difference|0.65|||<|0.001|TWO_SIDED|95.0|0.46|0.85||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||2 hours: Treatment difference \[Ibuprofen (Motrin IB) - placebo\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.85|0.46|<0.001
72434432|NCT01362491|144382031|SUPERIORITY_OR_OTHER||Least Square (LS) mean difference|-0.03||||0.669|TWO_SIDED|95.0|-0.19|0.13||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||2 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.13|-0.19|0.669
72434433|NCT01362491|144382031|SUPERIORITY_OR_OTHER||Least Square (LS) mean difference|0.84|||<|0.001|TWO_SIDED|95.0|0.57|1.11||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||3 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.11|0.57|<0.001
72434434|NCT01362491|144382031|SUPERIORITY_OR_OTHER||Least Square (LS) mean difference|0.94|||<|0.001|TWO_SIDED|95.0|0.67|1.21||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||3 hours: Treatment difference \[Ibuprofen (Motrin IB) - placebo\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.21|0.67|<0.001
72434435|NCT01362491|144382031|SUPERIORITY_OR_OTHER||Least Square (LS) mean difference|-0.1||||0.396|TWO_SIDED|95.0|-0.32|0.13||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||3 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.13|-0.32|0.396
72434436|NCT01362491|144382032|SUPERIORITY_OR_OTHER||Least Square (LS) mean difference|1.8|||<|0.001|TWO_SIDED|95.0|1.3|2.3||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1 hour: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||2.30|1.30|<0.001
72434437|NCT01362491|144382032|SUPERIORITY_OR_OTHER||Least Square (LS) mean difference|1.78|||<|0.001|TWO_SIDED|95.0|1.28|2.28||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1 hour: Treatment difference \[Ibuprofen (Motrin IB) - placebo\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||2.28|1.28|<0.001
72557384|NCT05143801|144645402|EQUIVALENCE|Interaction effect across environmental and mask conditions.||||||0.045||||||A Bonferroni post-hoc test was used if significant interaction effect was present and p-values were adjusted based on the number of comparisons. To determine if a post-hoc was needed statistical significance was set to p \< 0.05.|2x2 Repeated Measures ANOVA|||||||0.045
72434438|NCT01362491|144382032|SUPERIORITY_OR_OTHER||Least Square (LS) mean difference|0.02||||0.911|TWO_SIDED|95.0|-0.39|0.43||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1 hour: Treatment difference \[Ibuprofen sodium - Ibuprofen (Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.43|-0.39|0.911
72434439|NCT01362491|144382032|SUPERIORITY_OR_OTHER||Least Square (LS) mean difference|1.87|||<|0.001|TWO_SIDED|95.0|1.33|2.41||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||2 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||2.41|1.33|<0.001
72434440|NCT01362491|144382032|SUPERIORITY_OR_OTHER||Least Square (LS) mean difference|1.88|||<|0.001|TWO_SIDED|95.0|1.34|2.42||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||2 hours: Treatment difference \[Ibuprofen (Motrin IB) - placebo\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||2.42|1.34|<0.001
72434441|NCT01362491|144382032|SUPERIORITY_OR_OTHER||Least Square (LS) mean difference|0.0||||0.982|TWO_SIDED|95.0|-0.45|0.44||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||2 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.44|-0.45|0.982
72557385|NCT05143801|144645403|EQUIVALENCE|Main effect for environmental condition.||||||0.018||||||Statistical significance was set at p \< 0.05|2x2x3 Repeated Measures ANOVA|||||||0.018
72557386|NCT05143801|144645403|EQUIVALENCE|Main effect for mask condition.|||||<|0.001||||||Statistical significance was set at p \< 0.05|2x2x3 Repeated Measures ANOVA|||||||<0.001
72494070|NCT01390909|144517164|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|29.0|||<|0.0001|TWO_SIDED|95.0|18.0|42.0||Adjusted Cost Differences in Neurologist Visits, All Medical Costs|Ordinary Least Squares Regression|Covariates were gender, age, region, comorbidities, AEDs and non-AEDs known to increase seizure risk and baseline costs.||||42|18|<0.0001
72494071|NCT01390909|144517164|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|235.0||||0.7628|TWO_SIDED|95.0|-1367.0|1798.0||Adjusted Cost Differences in Other Healthcare Services, All Medical Costs|Ordinary Least Squares Regression|Covariates were gender, age, region, comorbidities, AEDs and non-AEDs known to increase seizure risk and baseline costs.||||1798|-1367|0.7628
72382242|NCT02247531|144273268|SUPERIORITY||Difference in Adjusted Means|-1.1||||0.1754|TWO_SIDED|95.0|-2.8|0.5|||MMRM|||Week 48: MMRM analysis uses change as response variable and included treatment group, visit, treatment-by-visit interaction, baseline LLVA, GA lesion location, biomarker status, modified baseline BCVA ETDRS chart Snellen equivalent category, and sex.||0.5|-2.8|0.1754
72382243|NCT02247531|144273269|SUPERIORITY||Odds Ratio (OR)|1.3||||0.3707|TWO_SIDED|95.0|0.7|2.2|||Regression, Logistic|||||2.2|0.7|0.3707
72382244|NCT02247531|144273269|SUPERIORITY||Odds Ratio (OR)|0.9||||0.8382|TWO_SIDED|95.0|0.6|1.6|||Regression, Logistic|||||1.6|0.6|0.8382
72382245|NCT02247531|144273270|SUPERIORITY||Difference in Adjusted Means|1.35||||0.6841|TWO_SIDED|95.0|-5.16|7.85|||MMRM|||Week 48: MMRM analysis uses change as response variable and included treatment group, baseline maximum reading speed, type of reading charts, baseline BCVA of better seeing eye, biomarker status, and sex.||7.85|-5.16|0.6841
72382246|NCT02247531|144273270|SUPERIORITY||Difference in Adjusted Means|1.07||||0.7443|TWO_SIDED|95.0|-5.37|7.52|||MMRM|||Week 48: MMRM analysis uses change as response variable and included treatment group, baseline maximum reading speed, type of reading charts, baseline BCVA of better seeing eye, biomarker status, and sex.||7.52|-5.37|0.7443
72382247|NCT02247531|144273271|SUPERIORITY||Difference in Adjusted Means|0.12||||0.9713|TWO_SIDED|95.0|-6.28|6.52|||MMRM|||Week 48: MMRM analysis uses change as response variable and included treatment group, baseline maximum reading speed, biomarker status, modified baseline BCVA, and sex.||6.52|-6.28|0.9713
72382248|NCT02247531|144273271|SUPERIORITY||Difference in Adjusted Means|-1.72||||0.5945|TWO_SIDED|95.0|-8.08|4.63|||MMRM|||Week 48: MMRM analysis uses change as response variable and included treatment group, baseline maximum reading speed, biomarker status, modified baseline BCVA, and sex.||4.63|-8.08|0.5945
72382249|NCT02247531|144273272|SUPERIORITY||Difference in Adjusted Means|1.22||||0.2438|TWO_SIDED|95.0|-0.83|3.27|||MMRM|||Week 48: MMRM analysis uses change as response variable and included treatment group, baseline score, baseline BCVA of better seeing eye, biomarker status, and sex.||3.27|-0.83|0.2438
72382250|NCT02247531|144273272|SUPERIORITY||Difference in Adjusted Means|1.03||||0.3202|TWO_SIDED|95.0|-1.01|3.07|||MMRM|||Week 48: MMRM analysis uses change as response variable and included treatment group, baseline score, baseline BCVA of better seeing eye, biomarker status, and sex.||3.07|-1.01|0.3202
72382251|NCT02247531|144273273|SUPERIORITY||Difference in Adjusted Means|2.64||||0.0388|TWO_SIDED|95.0|0.14|5.14|||MMRM|||Week 48: MMRM analysis uses change as response variable and included treatment group, baseline score, baseline BCVA of better seeing eye, biomarker status, and sex.||5.14|0.14|0.0388
72382252|NCT02247531|144273273|SUPERIORITY||Difference in Adjusted Means|2.2||||0.0833|TWO_SIDED|95.0|-0.29|4.68|||MMRM|||Week 48: MMRM analysis uses change as response variable and included treatment group, baseline score, baseline BCVA of better seeing eye, biomarker status, and sex.||4.68|-0.29|0.0833
72382253|NCT02247531|144273274|SUPERIORITY||Difference in Adjusted Means|1.04||||0.4795|TWO_SIDED|95.0|-1.84|3.91|||MMRM|||Week 48: MMRM analysis uses change as response variable and included treatment group, baseline score, baseline BCVA of better seeing eye, biomarker status, and sex.||3.91|-1.84|0.4795
72382254|NCT02247531|144273274|SUPERIORITY||Difference in Adjusted Means|0.6||||0.6822|TWO_SIDED|95.0|-2.26|3.45|||MMRM|||Week 48: MMRM analysis uses change as response variable and included treatment group, baseline score, baseline BCVA of better seeing eye, biomarker status, and sex.||3.45|-2.26|0.6822
72382255|NCT02247531|144273275|SUPERIORITY||Difference in Adjusted Means|0.04||||0.5227|TWO_SIDED|95.0|-0.07|0.14|||MMRM|||Week 48: MMRM analysis uses change as response variable and included treatment group, baseline Mean FRI Index score, baseline BCVA of better seeing eye, biomarker status, and sex.||0.14|-0.07|0.5227
72382256|NCT02247531|144273275|SUPERIORITY||Difference in Adjusted Means|0.02||||0.7475|TWO_SIDED|95.0|-0.09|0.13|||MMRM|||Week 48: MMRM analysis uses change as response variable and included treatment group, baseline Mean FRI Index score, baseline BCVA of better seeing eye, biomarker status, and sex.||0.13|-0.09|0.7475
72382257|NCT02247531|144273276|SUPERIORITY||Difference in Adjusted Means|0.049||||0.6333|TWO_SIDED|95.0|-0.153|0.252|||MMRM|||CFI Positive: MMRM analysis uses change as response variable and included treatment group, visit, treatment-by-visit interaction, baseline GA area, lesion location, contiguity, biomarker status, modified baseline BCVA and sex.||0.252|-0.153|0.6333
72382258|NCT02247531|144273276|SUPERIORITY||Difference in Adjusted Means|0.025||||0.8105|TWO_SIDED|95.0|-0.18|0.23|||MMRM|||CFI Positive: MMRM analysis uses change as response variable and included treatment group, visit, treatment-by-visit interaction, baseline GA area, lesion location, contiguity, biomarker status, modified baseline BCVA and sex.||0.230|-0.180|0.8105
72382259|NCT02247531|144273276|SUPERIORITY||Difference in Adjusted Means|0.34||||0.0063|TWO_SIDED|95.0|0.097|0.584|||MMRM|||CFI Negative: MMRM analysis uses change as response variable and included treatment group, visit, treatment-by-visit interaction, baseline GA area, lesion location, contiguity, biomarker status, modified baseline BCVA and sex.||0.584|0.097|0.0063
72382260|NCT02247531|144273276|SUPERIORITY||Difference in Adjusted Means|0.182||||0.1359|TWO_SIDED|95.0|-0.058|0.422|||MMRM|||CFI Negative: MMRM analysis uses change as response variable and included treatment group, visit, treatment-by-visit interaction, baseline GA area, lesion location, contiguity, biomarker status, modified baseline BCVA and sex.||0.422|-0.058|0.1359
72382261|NCT01298531|144273324|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-27.27||||0.0019|TWO_SIDED|95.0|-44.17|-10.38|||ANCOVA|Not specifed.||The primary analysis of the primary endpoint was an Analysis of covariance (ANCOVA)with Baseline NSAID score and treatment as explanatory variables. The hypothesis tested for the primary endpoint was as follows: H0: ΔETN = ΔPlacebo; H1: ΔETN ≠ ΔPlacebo.||-10.38|-44.17|0.0019
72382262|NCT01298531|144273325|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.78||||0.0115|TWO_SIDED|95.0|-34.99|-4.57|||ANCOVA|||The analysis of secondary endpoints was an ANCOVA using linear regression with Baseline NSAID score and MMRM was run using the model and using the repeated measures for the changes from Baseline in each outcome at Week 8.||-4.57|-34.99|0.0115
72382263|NCT01298531|144273326|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.93||||0.0153|TWO_SIDED|95.0|-1.68|-0.18|||ANCOVA|||The analysis of secondary endpoints was an ANCOVA using linear regression with Baseline NSAID score and MMRM was run using the model as detailed for the primary endpoint and using the repeated measures for the changes from Baseline in each outcome at Week 4.||-0.18|-1.68|0.0153
72382264|NCT01298531|144273327|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.88||||0.051|TWO_SIDED|95.0|-1.76|0.0|||ANCOVA|||The analysis of secondary endpoints was an ANCOVA using linear regression with Baseline NSAID score and MMRM was run using the model as detailed for the primary endpoint and using the repeated measures for the changes from Baseline in each outcome at Week 8.||0.00|-1.76|0.0510
72382265|NCT01298531|144273329|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.209||||0.0066|TWO_SIDED|95.0|0.07|0.65|||Regression, Logistic|||Logistic regression with baseline score and treatment group included as covariates.||0.65|0.07|0.0066
72382266|NCT01298531|144273330|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-53.7||||0.0053|TWO_SIDED|95.0|-91.01|-16.38|||ANCOVA|||The changes from baseline in the continuous endpoints of mini BASDAI was analyzed using ANCOVA. The total NSAID score for the first 8 weeks of randomized treatment was calculated as an AUC using the linear trapezoidal rule.||-16.38|-91.01|0.0053
72382267|NCT01298531|144273331|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.963||||0.0324|TWO_SIDED|95.0|1.1|8.01|||Regression, Logistic|||Logistic regression with baseline morning stiffness score and treatment group included as covariates.||8.01|1.10|0.0324
72382268|NCT01298531|144273334|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.696||||0.0501|TWO_SIDED|95.0|1.0|7.27|||Regression, Logistic|||Week 8 was analyzed using a logistic regression to assess treatment effect. Logistic regression with baseline morning stiffness score and treatment group included as covariates.||7.27|1.00|0.0501
72382269|NCT01298531|144273336|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.103||||0.0284|TWO_SIDED|95.0|1.13|8.54|||Regression, Logistic|||Week 8 was analyzed using a logistic regression to assess treatment effect. Logistic regression with baseline morning stiffness score and treatment group included as covariates.||8.54|1.13|0.0284
72434442|NCT01362491|144382032|SUPERIORITY_OR_OTHER||Least Square (LS) mean difference|2.44|||<|0.001|TWO_SIDED|95.0|1.72|3.15||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||3 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||3.15|1.72|<0.001
72494072|NCT01390909|144517164|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2306.0|||<|0.0001|TWO_SIDED|95.0|2016.0|2603.0||Adjusted Cost Differences in Epilepsy-Related Hospitalizations|Ordinary Least Squares Regression|Ordinary least squares regression was used to adjust differences. Covariates were gender, age, region, comorbidities, baseline treatment, and costs.|Confidence intervals were calculated using a nonparametric bootstrap with 999 replications.|||2603|2016|<0.0001
72494073|NCT01390909|144517164|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|63.0|||<|0.0001|TWO_SIDED|95.0|52.0|74.0||Adjusted Cost Differences in Epilepsy-Related Emergency Department Visits|Ordinary Least Squares Regression|Ordinary least squares regression was used to adjust differences. Covariates were gender, age, region, comorbidities, baseline treatment, and costs.|Confidence intervals were calculated using a nonparametric bootstrap with 999 replications.|||74|52|<0.0001
72618674|NCT01026038|144768107|SUPERIORITY_OR_OTHER||GMC ratio|1.15|||||TWO_SIDED|95.0|0.58|2.28||||||Serotype 7F: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||2.28|0.58|
72618675|NCT01026038|144768107|SUPERIORITY_OR_OTHER||GMC ratio|0.4|||||TWO_SIDED|95.0|0.17|0.92||||||Serotype 7F: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||0.92|0.17|
72382270|NCT01298531|144273338|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.13||||0.3291|TWO_SIDED|95.0|0.47|9.72|||Regression, Logistic|||Week 8 was analyzed using a logistic regression to assess treatment effect. Logistic regression with baseline morning stiffness score and treatment group included as covariates.||9.72|0.47|0.3291
72382271|NCT01298531|144273339|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.78|||<|0.0001|TWO_SIDED|95.0|-1.11|-0.44|||ANCOVA|||ANCOVA model on change from baseline ASDAS CRP score fitting baseline ASDAS CRP score as a covariate, plus treatment as a factor.||-0.44|-1.11|<0.0001
72382272|NCT01298531|144273340|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.68||||0.0011|TWO_SIDED|95.0|-1.09|-0.28|||ANCOVA|||ANCOVA model on change from baseline ASDAS CRP score fitting baseline ASDAS CRP score as a covariate, plus treatment as a factor.||-0.28|-1.09|0.0011
72382273|NCT01298531|144273342|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.57||||0.0011|TWO_SIDED|95.0|-0.9|-0.24|||ANCOVA|||ANCOVA model on change from baseline ASDAS ESR score fitting baseline ASDAS ESR score as a covariate, plus treatment as a factor.||-0.24|-0.90|0.0011
72382274|NCT01298531|144273343|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.67||||0.0037|TWO_SIDED|95.0|-1.11|-0.22|||ANCOVA|||ANCOVA model on change from baseline ASDAS ESR score fitting baseline ASDAS ESR score as a covariate, plus treatment as a factor.||-0.22|-1.11|0.0037
72382275|NCT01298531|144273347|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.3||||0.005|TWO_SIDED|95.0|-2.2|-0.4|||ANCOVA|||ANCOVA model on change from baseline BAS-G score fitting baseline BAS-G score as a covariate, plus treatment as a factor.||-0.40|-2.20|0.0050
72382276|NCT01298531|144273348|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.24||||0.0256|TWO_SIDED|95.0|-2.33|-0.16|||ANCOVA|||ANCOVA model on change from baseline BAS-G score fitting baseline BAS-G score as a covariate, plus treatment as a factor.||-0.16|-2.33|0.0256
72382277|NCT01298531|144273350|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.01||||0.0474|TWO_SIDED|95.0|-2.0|-0.01|||ANCOVA|||ANCOVA model on change from baseline total back pain fitting baseline total back pain as a covariate, plus treatment as a factor.||-0.01|-2.00|0.0474
72382278|NCT01298531|144273351|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.28||||0.0212|TWO_SIDED|95.0|-2.36|-0.2|||ANCOVA|||ANCOVA model on change from baseline total back pain fitting baseline total back pain as a covariate, plus treatment as a factor||-0.20|-2.36|0.0212
72618676|NCT01026038|144768107|SUPERIORITY_OR_OTHER||GMC ratio|2.57|||||TWO_SIDED|95.0|1.5|4.39||||||Serotype 19A: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||4.39|1.50|
72434443|NCT01362491|144382032|SUPERIORITY_OR_OTHER||Least Square (LS) mean difference|2.61|||<|0.001|TWO_SIDED|95.0|1.9|3.33||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||3 hours: Treatment difference \[Ibuprofen (Motrin IB) - placebo\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||3.33|1.90|<0.001
72434444|NCT01362491|144382032|SUPERIORITY_OR_OTHER||Least Square (LS) mean difference|-0.18||||0.547|TWO_SIDED|95.0|-0.77|0.41||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||3 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.41|-0.77|0.547
72434445|NCT01362491|144382033|SUPERIORITY_OR_OTHER||Least Square (LS) mean difference|1.16|||<|0.001|TWO_SIDED|95.0|0.83|1.5||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPID 0-2: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.50|0.83|<0.001
72434446|NCT01362491|144382033|SUPERIORITY_OR_OTHER||Least Square (LS) mean difference|1.17|||<|0.001|TWO_SIDED|95.0|0.83|1.5||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPID 0-2: Treatment difference \[Ibuprofen (Motrin IB) - placebo\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.50|0.83|<0.001
72434447|NCT01362491|144382033|SUPERIORITY_OR_OTHER||Least Square (LS) mean difference|0.0||||0.992|TWO_SIDED|95.0|-0.28|0.27||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPID 0-2: Treatment difference \[Ibuprofen Sodium - Ibuprofen (Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.27|-0.28|0.992
72434448|NCT01362491|144382033|SUPERIORITY_OR_OTHER||Least Square (LS) mean difference|2.01|||<|0.001|TWO_SIDED|95.0|1.43|2.58||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPID 0-3: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||2.58|1.43|<0.001
72434449|NCT01362491|144382033|SUPERIORITY_OR_OTHER||Least Square (LS) mean difference|2.1|||<|0.001|TWO_SIDED|95.0|1.53|2.68||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPID 0-3: Treatment difference \[Ibuprofen (Motrin IB) - placebo\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||2.68|1.53|<0.001
72434450|NCT01362491|144382033|SUPERIORITY_OR_OTHER||Least Square (LS) mean difference|-0.1||||0.684|TWO_SIDED|95.0|-0.57|0.38||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPID 0-3: Treatment difference \[Ibuprofen Sodium - Ibuprofen (Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.38|-0.57|0.684
72434451|NCT01362491|144382034|SUPERIORITY_OR_OTHER||Least Square (LS) mean difference|2.51|||<|0.001|TWO_SIDED|95.0|1.85|3.17||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||TOTPAR 0-2: Treatment difference (Ibuprofen Sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||3.17|1.85|<0.001
72494074|NCT01390909|144517164|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|211.0|||<|0.0001|TWO_SIDED|95.0|179.0|245.0||Adjusted Cost Differences in Epilepsy-Related Outpatient Services|Ordinary Least Squares Regression|Ordinary least squares regression was used to adjust differences. Covariates were gender, age, region, comorbidities, baseline treatment, and costs.|Confidence intervals were calculated using a nonparametric bootstrap with 999 replications.|||245|179|<0.0001
72557387|NCT05143801|144645403|EQUIVALENCE|Interaction effect across environmental and mask conditions.||||||0.035||||||A Bonferroni post-hoc test was used if significant interaction effect was present and p-values were adjusted based on the number of comparisons. To determine if a post-hoc was needed statistical significance was set to p \< 0.05.|2x2x3 Repeated Measures ANOVA|||||||0.035
72434452|NCT01362491|144382034|SUPERIORITY_OR_OTHER||Least Square (LS) mean difference|2.49|||<|0.001|TWO_SIDED|95.0|1.83|3.15||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||TOTPAR 0-2: Treatment difference \[Ibuprofen (Motrin IB) - Placebo\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||3.15|1.83|<0.001
72434453|NCT01362491|144382034|SUPERIORITY_OR_OTHER||Least Square (LS) mean difference|0.02||||0.943|TWO_SIDED|95.0|-0.52|0.56||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||TOTPAR 0-2: Treatment difference \[Ibuprofen Sodium - Ibuprofen (Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.56|-0.52|0.943
72434454|NCT01362491|144382034|SUPERIORITY_OR_OTHER||Least Square (LS) mean difference|4.1|||<|0.001|TWO_SIDED|95.0|3.03|5.18||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||TOTPAR 0-3: Treatment difference (Ibuprofen Sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||5.18|3.03|<0.001
72434455|NCT01362491|144382034|SUPERIORITY_OR_OTHER||Least Square (LS) mean difference|4.17|||<|0.001|TWO_SIDED|95.0|3.09|5.24||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||TOTPAR 0-3: Treatment difference \[Ibuprofen (Motrin IB) - Placebo\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||5.24|3.09|<0.001
72382279|NCT01298531|144273353|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.31||||0.0198|TWO_SIDED|95.0|-2.4|-0.21|||ANCOVA|||ANCOVA model on change from baseline nocturnal back pain fitting baseline nocturnal back pain as a covariate, plus treatment as a factor||-0.21|-2.40|0.0198
72382280|NCT01298531|144273354|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.51||||0.0132|TWO_SIDED|95.0|-2.69|-0.32|||ANCOVA|||ANCOVA model on change from baseline nocturnal back pain fitting baseline nocturnal back pain as a covariate, plus treatment as a factor||-0.32|-2.69|0.0132
72382281|NCT01298531|144273356|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.81||||0.0237|TWO_SIDED|95.0|-1.5|-0.11|||ANCOVA|||ANCOVA model on change from baseline BASFI score fitting baseline BASFI score as a covariate, plus treatment as a factor.||-0.11|-1.50|0.0237
72382282|NCT01298531|144273357|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.91||||0.0297|TWO_SIDED|95.0|-1.74|-0.09|||ANCOVA|||ANCOVA model on change from baseline BASFI score fitting baseline BASFI score as a covariate, plus treatment as a factor.||-0.09|-1.74|0.0297
72382283|NCT01298531|144273358|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.16||||0.0152|TWO_SIDED|95.0|-2.09|-0.23|||ANCOVA|||ANCOVA model on change from each baseline BASDAI component score fitting each baseline component score as a covariate, plus treatment as a factor.||-0.23|-2.09|0.0152
72382284|NCT01298531|144273359|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.15||||0.0344|TWO_SIDED|95.0|-2.22|-0.09|||ANCOVA|||ANCOVA model on change from each baseline BASDAI component score fitting each baseline component score as a covariate, plus treatment as a factor.||-0.09|-2.22|0.0344
72382285|NCT01298531|144273361|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.34||||0.0017|TWO_SIDED|95.0|-2.16|-0.52|||ANCOVA|||ANCOVA model on change from baseline PGA score fitting baseline PGA score as a covariate, plus treatment as a factor||-0.52|-2.16|0.0017
72382286|NCT01298531|144273362|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.12||||0.0233|TWO_SIDED|95.0|-2.07|-0.16|||ANCOVA|||ANCOVA model on change from baseline PGA score fitting baseline PGA score as a covariate, plus treatment as a factor.||-0.16|-2.07|0.0233
72382287|NCT01298531|144273371|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.01||||0.126|TWO_SIDED|95.0|0.822|4.901|||Regression, Logistic|||Week 8 was analyzed using logistic regression with baseline score and treatment group included as covariates.||4.901|0.822|0.1260
72382288|NCT01298531|144273374|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.47||||0.0498|TWO_SIDED|95.0|1.0|6.08|||Regression, Logistic|||Logistic regression with baseline morning stiffness score and treatment group included as covariates. Week 8 was analyzed using a logistic regression to assess treatment effect.||6.08|1.00|0.0498
72382289|NCT01298531|144273376|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.36||||0.1601|TWO_SIDED|95.0|-0.87|0.15|||ANCOVA|||ANCOVA model on change from baseline BASMI score fitting baseline BASMI score as a covariate, plus treatment as a factor||0.15|-0.87|0.1601
72382290|NCT01298531|144273377|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3||||0.2967|TWO_SIDED|95.0|-0.86|0.27|||ANCOVA|||ANCOVA model on change from baseline BASMI score fitting baseline BASMI score as a covariate, plus treatment as a factor||0.27|-0.86|0.2967
72382291|NCT01298531|144273383|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.41||||0.2735|TWO_SIDED|95.0|-1.94|6.75|||ANCOVA|||ANCOVA model on change from baseline in chest expansion mobility score fitting baseline chest expansion mobility score as a covariate, plus treatment as a factor.||6.75|-1.94|0.2735
72382292|NCT01298531|144273384|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.68||||0.0422|TWO_SIDED|95.0|0.02|1.34|||ANCOVA|||ANCOVA model on change from baseline in chest expansion mobility score fitting baseline chest expansion mobility score as a covariate, plus treatment as a factor.||1.34|0.02|0.0422
72382293|NCT01288027|144273386|SUPERIORITY_OR_OTHER|||||||0.186|TWO_SIDED||||||one sample t-test|||Statistical significance for change from Baseline was measured using one sample t-test||||0.1860
72494075|NCT01390909|144517164|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|23.0|||<|0.0001|TWO_SIDED|95.0|15.0|33.0||Adjusted Cost Differences in Epilepsy-Related Neurologist Visits|Ordinary Least Squares Regression|Ordinary least squares regression was used to adjust differences. Covariates were gender, age, region, comorbidities, baseline treatment, and costs.|Confidence intervals were calculated using a nonparametric bootstrap with 999 replications.|||33|15|<0.0001
72382294|NCT00994318|144273393|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.65||||0.026|TWO_SIDED|95.0|0.44|0.95|||Log Rank|||"FCM (Ferinject / Injectafer) targeting high ferritin level (400 - 600 mcg/L) compared with Oral Iron (Ferrous sulphate 100 mg iron twice daily).~Three primary comparisons using a hierarchical step-down procedure on the log-rank test to preserve the overall alpha level of 0.05, performed in the following order:~1. FCM (high ferritin target) compared with oral iron.~2. FCM (high ferritin target) compared with FCM (low ferritin target).~3. FCM (low ferritin target) compared with oral iron."||0.95|0.44|0.026
72382295|NCT00994318|144273393|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.68||||0.082|TWO_SIDED|95.0|0.45|1.05|||Log Rank|||"FCM (Ferinject / Injectafer) targeting high ferritin level (400-600mcg/L) compared with FCM targeting low ferritin level (100 - 200 mcg/L).~Three primary comparisons using a hierarchical step-down procedure on the log-rank test to preserve the overall alpha level of 0.05, performed in the following order:~1. FCM (high ferritin target) compared with oral iron.~2. FCM (high ferritin target) compared with FCM (low ferritin target).~3. FCM (low ferritin target) compared with oral iron."||1.05|0.45|0.082
72382296|NCT00994318|144273393|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.6||||0.02|TWO_SIDED|95.0|0.39|0.93|||Log Rank|||"Sensitivity analysis of the primary endpoint. Time to initiation of additional or alternative anaemia management without taking into account the Hb trigger.~FCM (Ferinject / Injectafer) targeting high ferritin level (400 - 600 mcg/L) compared with Oral Iron (Ferrous sulphate 100 mg iron twice daily)."||0.93|0.39|0.020
72382297|NCT00994318|144273393|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.62||||0.008|TWO_SIDED|95.0|0.43|0.88|||Log Rank|||"Sensitivity analysis of the primary endpoint. Time to initiation of additional or alternative anaemia management taking into account the Hb trigger based on local laboratory data, instead of central laboratory data.~FCM (Ferinject / Injectafer) targeting high ferritin level (400 - 600 mcg/L) compared with Oral Iron (Ferrous sulphate 100 mg iron twice daily)."||0.88|0.43|0.008
72382298|NCT00994318|144273393|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.7||||0.12|TWO_SIDED|95.0|0.45|1.1|||Log Rank|||"Sensitivity analysis of the primary endpoint. Time to initiation of additional or alternative anaemia management taking into account the Hb trigger based on subjects with a complete set of Hb values from central laboratory.~FCM (Ferinject / Injectafer) targeting high ferritin level (400 - 600 mcg/L) compared with Oral Iron (Ferrous sulphate 100 mg iron twice daily)"||1.10|0.45|0.12
72434456|NCT01362491|144382034|SUPERIORITY_OR_OTHER||Least Square (LS) mean difference|-0.06||||0.888|TWO_SIDED|95.0|-0.95|0.82||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||TOTPAR 0-3: Treatment difference \[Ibuprofen Sodium - Ibuprofen (Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.82|-0.95|0.888
72434457|NCT01362491|144382035|SUPERIORITY_OR_OTHER||Least Square (LS) mean difference|3.67|||<|0.001|TWO_SIDED|95.0|2.71|4.64||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPRID 0-2: Treatment difference (Ibuprofen Sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||4.64|2.71|<0.001
72434458|NCT01362491|144382035|SUPERIORITY_OR_OTHER||Least Square (LS) mean difference|3.66|||<|0.001|TWO_SIDED|95.0|2.68|4.63||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPRID 0-2: Treatment difference \[Ibuprofen (Motrin IB) - placebo\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||4.63|2.68|<0.001
72434459|NCT01362491|144382035|SUPERIORITY_OR_OTHER||Least Square (LS) mean difference|0.02||||0.964|TWO_SIDED|95.0|-0.78|0.82||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPRID 0-2: Treatment difference \[Ibuprofen Sodium - Ibuprofen (Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.82|-0.78|0.964
72434460|NCT01362491|144382035|SUPERIORITY_OR_OTHER||Least Square (LS) mean difference|6.27|||<|0.001|TWO_SIDED|95.0|4.65|7.89||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPRID 0-3: Treatment difference \[Ibuprofen (Motrin IB) - placebo\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||7.89|4.65|<0.001
72434461|NCT01362491|144382035|SUPERIORITY_OR_OTHER||Least Square (LS) mean difference|-0.16||||0.812|TWO_SIDED|95.0|-1.49|1.17||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPRID 0-3: Treatment difference \[Ibuprofen Sodium - Ibuprofen (Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.17|-1.49|0.812
72434462|NCT01362491|144382036|SUPERIORITY_OR_OTHER||Difference in proportion|12.02||||0.015|TWO_SIDED|95.0|5.27|18.77||p-value was calculated using CMH test which was adjusted for baseline Pain Severity Rating (PSR) and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||0.5 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||18.77|5.27|0.015
72434463|NCT01362491|144382036|SUPERIORITY_OR_OTHER||Difference in proportion|4.5||||0.146|TWO_SIDED|95.0|0.13|8.88||p-value was calculated using CMH test which was adjusted for baseline Pain Severity Rating (PSR) and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||0.5 hours: Treatment difference \[Ibuprofen (Motrin IB) - placebo\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||8.88|0.13|0.146
72434464|NCT01362491|144382036|SUPERIORITY_OR_OTHER||Difference in proportion|7.62||||0.064|TWO_SIDED|95.0|-0.38|15.63||p-value was calculated using CMH test which was adjusted for baseline Pain Severity Rating (PSR) and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||0.5 hours: Treatment difference \[Ibuprofen Sodium - Ibuprofen (Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||15.63|-0.38|0.064
72494076|NCT01390909|144517164|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|277.0||||0.0581|TWO_SIDED|95.0|-19.0|581.0||Adjusted Cost Differences in Other Epilepsy-Related Healthcare Costs|Ordinary Least Squares Regression|Ordinary least squares regression was used to adjust differences. Covariates were gender, age, region, comorbidities, baseline treatment, and costs.|Confidence intervals were calculated using a nonparametric bootstrap with 999 replications.|||581|-19|0.0581
72494077|NCT01390909|144517164|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5437.0|||<|0.0001|TWO_SIDED|95.0|3672.0|7142.0||Adjusted Cost Differences in Total Healthcare Costs|Ordinary Least Squares Regression|Covariates were gender, age, region, comorbidities, AEDs and non-AEDs known to increase seizure risk and baseline costs.||||7142|3672|<0.0001
72494078|NCT01390909|144517164|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1019.0|||<|0.0001|TWO_SIDED|95.0|836.0|1191.0||Adjusted Cost Differences in Prescription Drug Costs, AEDs|Ordinary Least Squares Regression|Covariates were gender, age, region, comorbidities, AEDs and non-AEDs known to increase seizure risk and baseline costs.||||1191|836|<0.0001
72494079|NCT01390909|144517164|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|1047.0|||<|0.0001|TWO_SIDED|95.0|564.0|1486.0||Adjusted Cost Differences in Prescription Drug Costs, Non-AEDs|Ordinary Least Squares Regression|Covariates were gender, age, region, comorbidities, AEDs and non-AEDs known to increase seizure risk and baseline costs.||||1486|564|<0.0001
72494080|NCT01390909|144517164|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|9128.0|||<|0.0001|TWO_SIDED|95.0|7346.0|11125.0||Adjusted Cost Differences in Hospitalizations|Ordinary Least Squares Regression|Covariates were gender, age, region, comorbidities, AEDs and non-AEDs known to increase seizure risk and baseline costs.||||11125|7346|<0.0001
72494081|NCT01390909|144517164|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|459.0|||<|0.0001|TWO_SIDED|95.0|326.0|622.0||Adjusted Cost Differences in Emergency Department Visits|Ordinary Least Squares Regression|Covariates were gender, age, region, comorbidities, AEDs and non-AEDs known to increase seizure risk and baseline costs.||||622|326|<0.0001
72494082|NCT01390909|144517164|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|2427.0|||<|0.0001|TWO_SIDED|95.0|1587.0|3290.0||Adjusted Cost Differences in Outpatient Services|Ordinary Least Squares Regression|Covariates were gender, age, region, comorbidities, AEDs and non-AEDs known to increase seizure risk and baseline costs.||||3290|1587|<0.0001
72494083|NCT01390909|144517164|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|357.0|||<|0.0001|TWO_SIDED|95.0|225.0|525.0||Adjusted Cost Differences in Neurologists Visits|Ordinary Least Squares Regression|Covariates were gender, age, region, comorbidities, AEDs and non-AEDs known to increase seizure risk and baseline costs.||||525|225|<0.0001
72382299|NCT02694523|144273402|OTHER||difference in percentage of participants|24.9|||<|0.001|TWO_SIDED|95.0|17.5|32.4|||Cochran-Mantel-Haenszel|||P-value calculated according to the Cochran-Mantel-Haenszel test adjusted for baseline weight (≤100 kg vs \>100 kg) and prior exposure to tumor necrosis factor (TNF) antagonists (0 vs ≥1).||32.4|17.5|<0.001
72494084|NCT01390909|144517164|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|502.0|||<|0.0001|TWO_SIDED|95.0|234.0|768.0||Adjusted Cost Differences in Other Healthcare Services|Ordinary Least Squares Regression|Covariates were gender, age, region, comorbidities, AEDs and non-AEDs known to increase seizure risk and baseline costs.||||768|234|<0.0001
72494085|NCT01390909|144517164|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6483.0|||<|0.0001|TWO_SIDED|95.0|5329.0|7927.0||Adjusted Cost Differences in Epilepsy-Related Hospitalizations|Ordinary Least Squares Regression|Ordinary least squares regression was used to adjust differences. Covariates were gender, age, region, comorbidities, baseline treatment, and costs.|Confidence intervals were calculated using a nonparametric bootstrap with 999 replications.|||7927|5329|<0.0001
72557388|NCT05143801|144645404|EQUIVALENCE|Main effect for environmental condition.|||||<|0.001||||||Statistical significance was set at p \< 0.05|2x2 Repeated Measures ANOVA|||||||<0.001
72382300|NCT02694523|144273403|OTHER||difference in percentage of participants|23.3|||<|0.001|TWO_SIDED|95.0|16.6|30.1|||Cochran-Mantel-Haenszel|||P-value calculated according to the Cochran-Mantel-Haenszel test adjusted for baseline weight (≤100 kg vs \>100 kg) and prior exposure to TNF antagonists (0 vs ≥1).||30.1|16.6|<0.001
72382301|NCT02694523|144273404|OTHER||difference in percentage of participants|45.0|||<|0.001|TWO_SIDED|95.0|28.9|61.1|||Cochran-Mantel-Haenszel|||P-value calculated according to the Cochran-Mantel-Haenszel test adjusted for baseline weight (≤100 kg vs \>100 kg) and prior exposure to TNF antagonists (0 vs ≥1).||61.1|28.9|<0.001
72382302|NCT02694523|144273405|OTHER||difference in percentage of participants|18.9|||<|0.001|TWO_SIDED|95.0|13.0|24.9|||Cochran-Mantel-Haenszel|||P-value calculated according to the Cochran-Mantel-Haenszel test adjusted for baseline weight (≤100 kg vs \>100 kg) and prior exposure to TNF antagonists (0 vs ≥1).||24.9|13.0|<0.001
72382303|NCT02694523|144273406|OTHER||difference in percentage of participants|16.7|||<|0.001|TWO_SIDED|95.0|9.5|23.9|||Cochran-Mantel-Haenszel|||P-value calculated according to the Cochran-Mantel-Haenszel test adjusted for baseline weight (≤100 kg vs \>100 kg) and prior exposure to TNF antagonists (0 vs ≥1).||23.9|9.5|<0.001
72382304|NCT02694523|144273407|OTHER||difference in percentage of participants|32.8|||<|0.001|TWO_SIDED|95.0|18.8|46.9|||Cochran-Mantel-Haenszel|||P-value calculated according to the Cochran-Mantel-Haenszel test adjusted for baseline weight (≤100 kg vs \>100 kg) and prior exposure to TNF antagonists (0 vs ≥1).||46.9|18.8|<0.001
72382305|NCT02694523|144273408|OTHER||difference in percentage of participants|32.8|||<|0.001|TWO_SIDED|95.0|18.8|46.9|||Cochran-Mantel-Haenszel|||P-value calculated according to the Cochran-Mantel-Haenszel test adjusted for baseline weight (≤100 kg vs \>100 kg) and prior exposure to TNF antagonists (0 vs ≥1).||46.9|18.8|<0.001
72382306|NCT02694523|144273409|OTHER||difference in percentage of participants|38.9|||<|0.001|TWO_SIDED|95.0|22.0|55.8|||Cochran-Mantel-Haenszel|||P-value calculated according to the Cochran-Mantel-Haenszel test adjusted for baseline weight (≤100 kg vs \>100 kg) and prior exposure to TNF antagonists (0 vs ≥1).||55.8|22.0|<0.001
72382307|NCT05896748|144273426|OTHER||Ratio of geometric least square mean|0.948|||||TWO_SIDED|90.0|0.901|0.998|||Mixed effect analysisofcovariance(ANCOVA|||To compare the abdominal SC injection with gluteal IM injection for Ctau within CAB||0.998|0.901|
72382308|NCT05896748|144273426|OTHER||Ratio of geometric least square mean|0.935|||||TWO_SIDED|90.0|0.877|0.995|||Mixed effect analysisofcovariance(ANCOVA|||To compare the abdominal SC injection with gluteal IM injection for Ctau within CAB||0.995|0.877|
72382309|NCT05896748|144273426|OTHER||Ratio of geometric least square mean|0.934|||||TWO_SIDED|90.0|0.872|1.0|||Mixed effect analysisofcovariance(ANCOVA|||To compare the abdominal SC injection with gluteal IM injection for Ctau within CAB||1.000|0.872|
72382310|NCT05896748|144273426|OTHER||Ratio of geometric least square mean|0.999|||||TWO_SIDED|90.0|0.943|1.059|||Mixed effect analysisofcovariance(ANCOVA|||To compare the IM gluteal injections for Ctau within CAB||1.059|0.943|
72382311|NCT05896748|144273427|OTHER||Ratio of geometric least square mean|1.002|||||TWO_SIDED|90.0|0.952|1.056|||Mixed effect analysisofcovariance(ANCOVA|||To compare the abdominal SC injection with gluteal IM injection for Ctau within RPV||1.056|0.952|
72382312|NCT05896748|144273427|OTHER||Ratio of geometric least square mean|0.961|||||TWO_SIDED|90.0|0.921|1.002|||Mixed effect analysisofcovariance(ANCOVA|||To compare the abdominal SC injection with gluteal IM injection for Ctau within RPV||1.002|0.921|
72382313|NCT05896748|144273427|OTHER||Ratio of geometric least square mean|0.928|||||TWO_SIDED|90.0|0.885|0.973|||Mixed effect analysisofcovariance(ANCOVA|||To compare the abdominal SC injection with gluteal IM injection for Ctau within RPV||0.973|0.885|
72382314|NCT05896748|144273427|OTHER||Ratio of geometric least square mean|1.003|||||TWO_SIDED|90.0|0.955|1.053|||Mixed effect analysisofcovariance(ANCOVA|||To compare the IM gluteal injections for Ctau within RPV||1.053|0.955|
72382315|NCT05896748|144273428|OTHER||Ratio of geometric least square mean|0.942|||||TWO_SIDED|90.0|0.897|0.99|||Mixed effect analysisofcovariance(ANCOVA|||To compare the abdominal SC injection with gluteal IM injection for Cmax within CAB||0.990|0.897|
72382316|NCT05896748|144273428|OTHER||Ratio of geometric least square mean|0.911|||||TWO_SIDED|90.0|0.86|0.965|||Mixed effect analysisofcovariance(ANCOVA|||To compare the abdominal SC injection with gluteal IM injection for Cmax within CAB||0.965|0.860|
72382317|NCT05896748|144273428|OTHER||Ratio of geometric least square mean|0.91|||||TWO_SIDED|90.0|0.857|0.966|||Mixed effect analysisofcovariance(ANCOVA|||To compare the abdominal SC injection with gluteal IM injection for Cmax within CAB||0.966|0.857|
72382318|NCT05896748|144273428|OTHER||Ratio of geometric least square mean|1.003|||||TWO_SIDED|90.0|0.938|1.074|||Mixed effect analysisofcovariance(ANCOVA|||To compare the IM gluteal injections for Cmax within CAB||1.074|0.938|
72382319|NCT05896748|144273429|OTHER||Ratio of geometric least square mean|0.938|||||TWO_SIDED|90.0|0.895|0.982|||Mixed effect analysisofcovariance(ANCOVA|||To compare the abdominal SC injection with gluteal IM injection for Cmax within RPV||0.982|0.895|
72382320|NCT05896748|144273429|OTHER||Ratio of geometric least square mean|0.918|||||TWO_SIDED|90.0|0.876|0.963|||Mixed effect analysisofcovariance(ANCOVA|||To compare the abdominal SC injection with gluteal IM injection for Cmax within RPV||0.963|0.876|
72382321|NCT05896748|144273429|OTHER||Ratio of geometric least square mean|0.905|||||TWO_SIDED|90.0|0.861|0.952|||Mixed effect analysisofcovariance(ANCOVA|||To compare the abdominal SC injection with gluteal IM injection for Cmax within RPV||0.952|0.861|
72382322|NCT05896748|144273429|OTHER||Ratio of geometric least square mean|0.937|||||TWO_SIDED|90.0|0.891|0.986|||Mixed effect analysisofcovariance(ANCOVA|||To compare the IM gluteal injections for Cmax within RPV||0.986|0.891|
72382323|NCT05896748|144273430|OTHER||Ratio of geometric least square mean|0.944|||||TWO_SIDED|90.0|0.906|0.983|||Mixed effect analysisofcovariance(ANCOVA|||To compare the abdominal SC injection with gluteal IM injection for AUC\[0-tau\] within CAB||0.983|0.906|
72382324|NCT05896748|144273430|OTHER||Ratio of geometric least square mean|0.944|||||TWO_SIDED|90.0|0.895|0.995|||Mixed effect analysisofcovariance(ANCOVA|||To compare the abdominal SC injection with gluteal IM injection for AUC\[0-tau\] within CAB||0.995|0.895|
72382325|NCT05896748|144273430|OTHER||Ratio of geometric least square mean|0.933|||||TWO_SIDED|90.0|0.876|0.994|||Mixed effect analysisofcovariance(ANCOVA|||To compare the abdominal SC injection with gluteal IM injection for AUC\[0-tau\] within CAB||0.994|0.876|
72382326|NCT05896748|144273430|OTHER||Ratio of geometric least square mean|1.04|||||TWO_SIDED|90.0|0.979|1.105|||Mixed effect analysisofcovariance(ANCOVA|||To compare the IM gluteal injections for AUC\[0-tau\] within CAB||1.105|0.979|
72382327|NCT05896748|144273431|OTHER||Ratio of geometric least square mean|0.966|||||TWO_SIDED|90.0|0.932|1.002|||Mixed effect analysisofcovariance(ANCOVA|||To compare the abdominal SC injection with gluteal IM injection for AUC\[0-tau\] within RPV||1.002|0.932|
72382328|NCT05896748|144273431|OTHER||Ratio of geometric least square mean|0.955|||||TWO_SIDED|90.0|0.922|0.989|||Mixed effect analysisofcovariance(ANCOVA|||To compare the abdominal SC injection with gluteal IM injection for AUC\[0-tau\] within RPV||0.989|0.922|
72382329|NCT05896748|144273431|OTHER||Ratio of geometric least square mean|0.948|||||TWO_SIDED|90.0|0.907|0.991|||Mixed effect analysisofcovariance(ANCOVA|||To compare the abdominal SC injection with gluteal IM injection for AUC\[0-tau\] within RPV||0.991|0.907|
72434465|NCT01362491|144382036|SUPERIORITY_OR_OTHER||Difference in proportion|58.58|||<|0.001|TWO_SIDED|95.0|44.96|72.21||p-value was calculated using CMH test which was adjusted for baseline Pain Severity Rating (PSR) and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1 hour: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||72.21|44.96|<0.001
72382330|NCT05896748|144273431|OTHER||Ratio of geometric least square mean|1.014|||||TWO_SIDED|90.0|0.972|1.058|||Mixed effect analysisofcovariance(ANCOVA|||To compare the IM gluteal injections for AUC\[0-tau\] within RPV||1.058|0.972|
72382331|NCT04010539|144273502|NON_INFERIORITY|The difference in microbiological success rates between treatment groups (Gepotidacin - Ceftriaxone plus azithromycin) was calculated using the Miettinen-Nurminen Summary Score Method adjusted for sex and sexual orientation combination. Non-inferiority was declared if the lower limit of the 2-sided 95% confidence interval for the difference was above -10.0%.|Adjusted Difference in Percent|-0.1|||||TWO_SIDED|95.0|-5.6|5.5||||||||5.5|-5.6|
72382332|NCT04010539|144273502|SUPERIORITY|The difference in microbiological success rates between treatment groups (Gepotidacin - Ceftriaxone plus azithromycin) was calculated using the Miettinen-Nurminen Summary Score Method adjusted for sex and sexual orientation combination. Superiority was declared if the lower limit of the 2-sided 95% confidence interval for the difference was above 0.0%.|Adjusted Difference in Percent|-0.1||||0.5072|TWO_SIDED|95.0|-5.6|5.5|||1-sided p-value for Test of Superiority|||||5.5|-5.6|0.5072
72382333|NCT04231318|144273522|SUPERIORITY|||||||0.0406|||||||ANOVA|||||||0.0406
72382334|NCT04231318|144273522|SUPERIORITY|||||||0.0795|||||||ANOVA|||||||0.0795
72382335|NCT04231318|144273522|SUPERIORITY|||||||0.7601|||||||ANOVA|||||||0.7601
72382336|NCT04231318|144273523|SUPERIORITY|||||||0.1942|||||||ANOVA|||||||0.1942
72557389|NCT05143801|144645404|EQUIVALENCE|Main effect for mask condition.||||||0.678||||||Statistical significance was set at p \< 0.05|2x2 Repeated Measures ANOVA|||||||0.678
72382337|NCT04231318|144273523|SUPERIORITY|||||||0.0957|||||||ANOVA|||||||0.0957
72382338|NCT04231318|144273523|SUPERIORITY|||||||0.4526|||||||ANOVA|||||||0.4526
72382339|NCT04231318|144273524|SUPERIORITY|||||||0.1309|||||||ANOVA|||||||0.1309
72382340|NCT04231318|144273524|SUPERIORITY|||||||0.17|||||||ANOVA|||||||0.1700
72382341|NCT04231318|144273524|SUPERIORITY|||||||0.7609|||||||ANOVA|||||||0.7609
72382342|NCT04231318|144273525|SUPERIORITY|||||||0.1|||||||ANOVA|||||||0.1000
72382343|NCT04231318|144273525|SUPERIORITY|||||||0.0423|||||||ANOVA|||||||0.0423
72382344|NCT04231318|144273525|SUPERIORITY|||||||0.383|||||||ANOVA|||||||0.3830
72382345|NCT04231318|144273526|SUPERIORITY|||||||0.0298|||||||ANOVA|||||||0.0298
72382346|NCT04231318|144273526|SUPERIORITY|||||||0.0217|||||||ANOVA|||||||0.0217
72382347|NCT04231318|144273526|SUPERIORITY|||||||0.4451|||||||ANOVA|||||||0.4451
72382348|NCT04231318|144273527|SUPERIORITY|||||||0.1197|||||||ANOVA|||||||0.1197
72382349|NCT04231318|144273527|SUPERIORITY|||||||0.0008|||||||ANOVA|||||||0.0008
72382350|NCT04231318|144273527|SUPERIORITY|||||||0.0223|||||||ANOVA|||||||0.0223
72382351|NCT04231318|144273528|SUPERIORITY|||||||0.1067|||||||ANOVA|||||||0.1067
72382352|NCT04231318|144273529|SUPERIORITY|||||||0.1715|||||||ANOVA|||||||0.1715
72382353|NCT04231318|144273529|SUPERIORITY|||||||0.0736|||||||ANOVA|||||||0.0736
72382354|NCT04231318|144273529|SUPERIORITY|||||||0.4098|||||||ANOVA|||||||0.4098
72382355|NCT04231318|144273530|SUPERIORITY|||||||0.2718|||||||ANOVA|||||||0.2718
72382356|NCT04231318|144273530|SUPERIORITY|||||||0.0182|||||||ANOVA|||||||0.0182
72382357|NCT04231318|144273530|SUPERIORITY|||||||0.1131|||||||ANOVA|||||||0.1131
72382358|NCT04231318|144273531|SUPERIORITY|||||||0.2143|||||||ANOVA|||||||0.2143
72382359|NCT04231318|144273531|SUPERIORITY|||||||0.1628|||||||ANOVA|||||||0.1628
72382360|NCT04231318|144273531|SUPERIORITY|||||||0.6036|||||||ANOVA|||||||0.6036
72382361|NCT04231318|144273532|SUPERIORITY|||||||0.222|||||||ANOVA|||||||0.2220
72382362|NCT04231318|144273532|SUPERIORITY|||||||0.141|||||||ANOVA|||||||0.1410
72382363|NCT04231318|144273532|SUPERIORITY|||||||0.5418|||||||ANOVA|||||||0.5418
72382364|NCT04231318|144273533|SUPERIORITY|||||||0.1619|||||||ANOVA|||||||0.1619
72382365|NCT04231318|144273533|SUPERIORITY|||||||0.1683|||||||ANOVA|||||||0.1683
72382366|NCT04231318|144273533|SUPERIORITY|||||||0.6969|||||||ANOVA|||||||0.6969
72382367|NCT04231318|144273534|SUPERIORITY|||||||0.0701|||||||ANOVA|||||||0.0701
72382368|NCT04231318|144273534|SUPERIORITY|||||||0.0925|||||||ANOVA|||||||0.0925
72382369|NCT04231318|144273534|SUPERIORITY|||||||0.6981|||||||ANOVA|||||||0.6981
72382370|NCT04231318|144273535|SUPERIORITY|||||||0.0275|||||||ANOVA|||||||0.0275
72557390|NCT05143801|144645404|EQUIVALENCE|Interaction effect||||||0.678|||||||2x2 Repeated Measures ANOVA|||||||0.678
72557391|NCT05143801|144645405|EQUIVALENCE|Main effect for environmental condition.|||||<|0.001||||||Statistical significance was set at p \< 0.05|2x2 Repeated Measures ANOVA|||||||<0.001
72557392|NCT05143801|144645405|EQUIVALENCE|Main effect for mask condition.||||||0.487||||||Statistical significance was set at p \< 0.05|2x2 Repeated Measures ANOVA|||||||0.487
72557393|NCT05143801|144645405|EQUIVALENCE|Interaction effect across environmental and mask conditions.||||||0.79||||||A Bonferroni post-hoc test was used if significant interaction effect was present and p-values were adjusted based on the number of comparisons. To determine if a post-hoc was needed statistical significance was set to p \< 0.05.|2x2 Repeated Measures ANOVA|||||||0.790
72557394|NCT05143801|144645406|EQUIVALENCE|Main effect for environmental condition.||||||0.089||||||Statistical significance was set at p \< 0.05|2x2 Repeated Measures ANOVA|||||||0.089
72557395|NCT05143801|144645406|EQUIVALENCE|Main effect for mask condition.||||||0.297||||||Statistical significance was set at p \< 0.05|2x2 Repeated Measures ANOVA|||||||0.297
72557396|NCT05143801|144645406|EQUIVALENCE|Interaction effect across environmental and mask conditions.||||||0.111||||||A Bonferroni post-hoc test was used if significant interaction effect was present and p-values were adjusted based on the number of comparisons. To determine if a post-hoc was needed statistical significance was set to p \< 0.05.|2x2 Repeated Measures ANOVA|||||||0.111
72557397|NCT05143801|144645407|EQUIVALENCE|Main effect for environmental condition.||||||0.024||||||Statistical significance was set at p \< 0.05|2x2 Repeated Measures ANOVA|||||||0.024
72557398|NCT05143801|144645407|EQUIVALENCE|Main effect for mask condition.||||||0.002||||||Statistical significance was set at p \< 0.05|2x2 Repeated Measures ANOVA|||||||0.002
72557399|NCT05143801|144645407|EQUIVALENCE|Interaction effect across environmental and mask conditions.||||||0.014||||||A Bonferroni post-hoc test was used if significant interaction effect was present and p-values were adjusted based on the number of comparisons. To determine if a post-hoc was needed statistical significance was set to p \< 0.05.|2x2 Repeated Measures ANOVA|||||||0.014
72557400|NCT05143801|144645408|EQUIVALENCE|Main effect for environmental condition.||||||0.012||||||Statistical significance was set at p \< 0.05|2x2 Repeated Measures ANOVA|||||||0.012
72557401|NCT05143801|144645408|EQUIVALENCE|Main effect for mask condition.||||||0.893||||||Statistical significance was set at p \< 0.05|2x2 Repeated Measures ANOVA|||||||0.893
72557402|NCT05143801|144645408|EQUIVALENCE|Interaction effect across environmental and mask conditions.||||||0.969||||||A Bonferroni post-hoc test was used if significant interaction effect was present and p-values were adjusted based on the number of comparisons. To determine if a post-hoc was needed statistical significance was set to p \< 0.05.|2x2 Repeated Measures ANOVA|||||||0.969
72557403|NCT03629054|144645409|EQUIVALENCE|The assessment of bioequivalence was based upon two-sided 90% confidence intervals (CIs) for the ratios of the geometric means (gMean) (T/R).|Adjusted gMean ratio|100.42|STANDARD_ERROR_OF_MEAN|4.8|<|0.0001|TWO_SIDED|90.0|98.17|102.72|||ANOVA||gMean ratio = T/R. Standard error of the mean is actually intra-individual geometric coefficient of variation (gCV).|An ANOVA model on the logarithmic scale including fixed effects for 'sequence', 'period' and 'treatment' and random effect for 'subject within sequence'.||102.72|98.17|<0.0001
72557404|NCT03629054|144645410|EQUIVALENCE|The assessment of bioequivalence was based upon two-sided 90% CIs for the ratios of the geometric means (T/R).|Adjusted gMean ratio|95.34|STANDARD_ERROR_OF_MEAN|8.5|<|0.0001|TWO_SIDED|90.0|91.58|99.24|||ANOVA||gMean ratio = T/R. Standard Error of the mean is actually intra-individual gCV.|An ANOVA model on the logarithmic scale including fixed effects for 'sequence', 'period' and 'treatment' and random effect for 'subject within sequence'.||99.24|91.58|<0.0001
72557405|NCT03629054|144645411|EQUIVALENCE|The assessment of bioequivalence was based upon two-sided 90% CIs for the ratios of the geometric means (T/R).|Adjusted gMean ratio|100.16|STANDARD_ERROR_OF_MEAN|8.6|<|0.0001|TWO_SIDED|90.0|96.17|104.31|||ANOVA||gMean ratio = T/R. Standard Error of the mean is actually intra-individual gCV.|An ANOVA model on the logarithmic scale including fixed effects for 'sequence', 'period' and 'treatment' and random effect for 'subject within sequence'.||104.31|96.17|<0.0001
72557406|NCT03629054|144645412|EQUIVALENCE|The assessment of bioequivalence was based upon two-sided 90% CIs for the ratios of the geometric means (T/R).|Adjusted gMean ratio|92.57|STANDARD_ERROR_OF_MEAN|17.9||0.0029|TWO_SIDED|90.0|85.21|100.57|||ANOVA||gMean ratio = T/R. Standard Error of the mean is actually intra-individual gCV.|An ANOVA model on the logarithmic scale including fixed effects for 'sequence', 'period' and 'treatment' and random effect for 'subject within sequence'.||100.57|85.21|0.0029
72557407|NCT03629054|144645413|EQUIVALENCE|The assessment of bioequivalence was based upon two-sided 90% CIs for the ratios of the geometric means (T/R).|Adjusted gMean ratio|97.33|STANDARD_ERROR_OF_MEAN|16.9||0.0001|TWO_SIDED|90.0|89.99|105.26|||ANOVA||gMean ratio = T/R. Standard Error of the mean is actually intra-individual gCV.|An ANOVA model on the logarithmic scale including fixed effects for 'sequence', 'period' and 'treatment' and random effect for 'subject within sequence'.||105.26|89.99|0.0001
72557408|NCT03629054|144645414|EQUIVALENCE|The assessment of bioequivalence was based upon two-sided 90% CIs for the ratios of the geometric means (T/R).|Adjusted gMean ratio|104.83|STANDARD_ERROR_OF_MEAN|13.2|<|0.0001|TWO_SIDED|90.0|98.56|111.5|||ANOVA||gMean ratio = T/R. Standard Error of the mean is actually intra-individual gCV.|An ANOVA model on the logarithmic scale including fixed effects for 'sequence', 'period' and 'treatment' and random effect for 'subject within sequence'.||111.50|98.56|<0.0001
72382371|NCT04231318|144273535|SUPERIORITY|||||||0.1738|||||||ANOVA|||||||0.1738
72557409|NCT03629054|144645415|EQUIVALENCE|The assessment of bioequivalence was based upon two-sided 90% CIs for the ratios of the geometric means (T/R).|Adjusted gMean ratio|100.73|STANDARD_ERROR_OF_MEAN|5.1|<|0.0001|TWO_SIDED|90.0|98.33|103.18|||ANOVA||gMean ratio = T/R. Standard Error of the mean is actually intra-individual gCV.|An ANOVA model on the logarithmic scale including fixed effects for 'sequence', 'period' and 'treatment' and random effect for 'subject within sequence'.||103.18|98.33|<0.0001
72557410|NCT03629054|144645416|EQUIVALENCE|The assessment of bioequivalence was based upon two-sided 90% CIs for the ratios of the geometric means (T/R).|Adjusted gMean ratio|103.57|STANDARD_ERROR_OF_MEAN|14.3|<|0.0001|TWO_SIDED|90.0|96.9|110.71|||ANOVA||gMean ratio = T/R. Standard Error of the mean is actually intra-individual gCV.|An ANOVA model on the logarithmic scale including fixed effects for 'sequence', 'period' and 'treatment' and random effect for 'subject within sequence'.||110.71|96.90|<0.0001
72557411|NCT03629054|144645417|EQUIVALENCE|The assessment of bioequivalence was based upon two-sided 90% CIs for the ratios of the geometric means (T/R).|Adjusted gMean ratio|95.74|STANDARD_ERROR_OF_MEAN|7.8|<|0.0001|TWO_SIDED|90.0|92.29|99.32|||ANOVA||gMean ratio = T/R. Standard Error of the mean is actually intra-individual gCV.|An ANOVA model on the logarithmic scale including fixed effects for 'sequence', 'period' and 'treatment' and random effect for 'subject within sequence'.||99.32|92.29|<0.0001
72557412|NCT00205777|144645419|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.647||||0.22|TWO_SIDED|95.0|0.322|1.302|||Log Rank|||No Prevalent Fractures: P value was calculated using stratified log-rank test. Hazard ratio (Bazedoxifene 20 mg \[Core+SE I\] versus Placebo \[Core+SE I+SE II\]) based on a Cox proportional hazards regression model was presented along with 95% confidence intervals (CIs).||1.302|0.322|0.22
72557413|NCT00205777|144645419|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.647||||0.24|TWO_SIDED|95.0|0.322|1.301|||Log Rank|||No Prevalent Fractures: P value was calculated using stratified log-rank test. Hazard ratio (Bazedoxifene 40 mg \[Core\] versus Placebo \[Core+SE I+SE II\]) based on a Cox proportional hazards regression model was presented along with 95% CIs.||1.301|0.322|0.24
72557414|NCT00205777|144645419|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.097||||0.83|TWO_SIDED|95.0|0.501|2.405|||Log Rank|||No Prevalent Fractures: P value was calculated using stratified log-rank test. Hazard ratio (Bazedoxifene 40 mg \[Core\] versus Raloxifene 60 mg \[Core\]) based on a Cox proportional hazards regression model was presented along with 95% CIs.||2.405|0.501|0.83
72382372|NCT04231318|144273535|SUPERIORITY|||||||0.8364|||||||ANOVA|||||||0.8364
72382373|NCT04231318|144273536|SUPERIORITY|||||||0.2227|||||||ANOVA|||||||0.2227
72382374|NCT04231318|144273536|SUPERIORITY|||||||0.1114|||||||ANOVA|||||||0.1114
72382375|NCT04231318|144273536|SUPERIORITY|||||||0.4635|||||||ANOVA|||||||0.4635
72382376|NCT00667602|144273590|NON_INFERIORITY_OR_EQUIVALENCE|(PConcomitant Vaccine + MenACWY-CRM - PConcomitant Vaccine + MenC)|Percentage Difference|-8.0|||||TWO_SIDED|95.0|-15.0|-1.0|||Miettinen and Nurminen|Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.||The primary criterion for immunogenicity was that the lower limit of the two-sided 95% confidence interval (CI) for the difference between one dose of MenACWY-CRM197 and MenC in the percentage of subjects with hSBA ≥1:8 for serogroup C at 1 month following the 12 months vaccination was greater than -10% .||-1|-15|
72382377|NCT00667602|144273591|NON_INFERIORITY_OR_EQUIVALENCE|(PConcomitant Vaccine + MenACWY-CRM - PConcomitant Vaccine + MenC)|Percentage difference|-7.0|||||TWO_SIDED|95.0|-13.0|-2.0|||Miettinen and Nurminen|Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.||The primary criterion for immunogenicity was that the lower limit of the two-sided 95% confidence interval (CI) for the difference between one dose of MenACWY-CRM197 and MenC in the percentage of subjects with hSBA ≥ 1:4 for serogroup C at 1 month following the 12 months vaccination was greater than -10%.||-2|-13|
72382378|NCT00667602|144273592|NON_INFERIORITY_OR_EQUIVALENCE|(PMenACWY - PMenC \> -10%).|Mean Difference (Final Values)|72.0|||||TWO_SIDED|95.0|64.0|79.0|||Percentage difference|Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.||Comparisons to MenC were based on the percentages of subjects with response (hSBA ≥1:8, prevaccination) to serogroup C. MenACWY was determined to be noninferior to MenC if the lower limit of the two-sided 95% CI for the difference between MenACWY and MenC in the percentage of subjects with response towards serogroup C was greater than -10%.||79|64|
72382379|NCT00667602|144273592|NON_INFERIORITY_OR_EQUIVALENCE|(PMenACWY - PMenC \> -10%).|Mean Difference (Net)|7.0|||||TWO_SIDED|95.0|3.0|13.0|||Percentage difference|Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.||Comparisons to MenC were based on the percentages of subjects with response (hSBA ≥1:8, one month postvaccination) to serogroup C. MenACWY was determined to be noninferior to MenC if the lower limit of the two-sided 95% CI for the difference between MenACWY and MenC in the percentage of subjects with response towards serogroup C was greater than -10%.||13|3|
72382380|NCT00667602|144273592|NON_INFERIORITY_OR_EQUIVALENCE|(PMenACWY - PMenC \> -10%).|Mean Difference (Final Values)|80.0|||||TWO_SIDED|95.0|73.0|86.0|||Percentage difference|Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.||Comparisons to MenC were based on the percentages of subjects with response (hSBA ≥1:4, prevaccination) to serogroup C. MenACWY was determined to be noninferior to MenC if the lower limit of the two-sided 95% CI for the difference between MenACWY and MenC in the percentage of subjects with response towards serogroup C was greater than -10%.||86|73|
72434466|NCT01362491|144382036|SUPERIORITY_OR_OTHER||Difference in proportion|52.31|||<|0.001|TWO_SIDED|95.0|38.2|66.41||p-value was calculated using CMH test which was adjusted for baseline Pain Severity Rating (PSR) and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1 hour: Treatment difference \[Ibuprofen (Motrin IB) - placebo\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||66.41|38.20|<0.001
72434467|NCT01362491|144382036|SUPERIORITY_OR_OTHER||Difference in proportion|6.4||||0.357|TWO_SIDED|95.0|-7.27|20.07||p-value was calculated using CMH test which was adjusted for baseline Pain Severity Rating (PSR) and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1 hour: Treatment difference \[Ibuprofen Sodium - Ibuprofen (Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||20.07|-7.27|0.357
72557415|NCT00205777|144645419|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.074||||0.87|TWO_SIDED|95.0|0.49|2.356|||Log Rank|||No Prevalent Fractures: P value was calculated using stratified log-rank test. Hazard ratio (Bazedoxifene 20 mg \[Core+SE I\] versus Raloxifene 60 mg \[Core\]) based on a Cox proportional hazards regression model was presented along with 95% CIs.||2.356|0.490|0.87
72557416|NCT00205777|144645419|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.988||||0.96|TWO_SIDED|95.0|0.458|2.131|||Log Rank|||No Prevalent Fractures: P value was calculated using stratified log-rank test. Hazard ratio (Bazedoxifene 20 mg \[Core+SE I\] versus Bazedoxifene 40 mg \[Core\]) based on a Cox proportional hazards regression model was presented along with 95% CIs.||2.131|0.458|0.96
72557417|NCT00205777|144645419|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.592||||0.16|TWO_SIDED|95.0|0.289|1.212|||Log Rank|||No Prevalent Fractures: P value was calculated using stratified log-rank test. Hazard ratio (Raloxifene 60 mg \[Core\] versus Placebo \[Core+SE I+SE II\]) based on a Cox proportional hazards regression model was presented along with 95% CIs.||1.212|0.289|0.16
72382381|NCT00667602|144273592|NON_INFERIORITY_OR_EQUIVALENCE|(PMenACWY - PMenC \> -10%).|Mean Difference (Final Values)|1.0|||||TWO_SIDED|95.0|-2.0|5.0|||Percentage difference|Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.||Comparisons to MenC were based on the percentages of subjects with response (hSBA ≥1:4, one month postvaccination) to serogroup C. MenACWY was determined to be noninferior to MenC if the lower limit of the two-sided 95% CI for the difference between MenACWY and MenC in the percentage of subjects with response towards serogroup C was greater than -10%.||5|-2|
72382382|NCT00667602|144273594|NON_INFERIORITY_OR_EQUIVALENCE|(GMTMenACWY/GMTMenC \> 0.5).|Ratio|0.92|||||TWO_SIDED|95.0|0.76|1.12|||ANOVA|||For comparison of the Geometric Mean Titers, prevaccination at 12 months of age, MenACWY-CRM197 was determined to be non-inferior to MenC if the lower limit of the 2-sided 95% CI for the ratio of the MenACWY-CRM197 to MenC Geometric Mean Titers for serogroup C was greater than 0.5.||1.12|0.76|
72382383|NCT00667602|144273594|NON_INFERIORITY_OR_EQUIVALENCE|(GMTMenACWY/GMTMenC \> 0.5).|Ratio|0.73|||||TWO_SIDED|95.0|0.57|0.93|||ANOVA|||For comparison of the Geometric Mean Titers, one month postvaccination at 12 months of age, MenACWY-CRM197 was determined to be non-inferior to MenC if the lower limit of the 2-sided 95% CI for the ratio of the MenACWY-CRM197 to MenC Geometric Mean Titers for serogroup C was greater than 0.5.||0.93|0.57|
72382384|NCT00667602|144273596|NON_INFERIORITY_OR_EQUIVALENCE|(GMTMenACWY/GMTMenjugate \> 0.5).|Ratio|10.0|||||TWO_SIDED|95.0|8.43|13.0|||ANOVA|||For comparison of the GMTs (prevaccination), MenACWY was determined to be non-inferior to MenC if the lower limit of the two-sided 95% CI for the ratio of the MenACWY to MenC GMTs for serogroup C was greater than 0.5 .||13|8.43|
72382385|NCT00667602|144273596|NON_INFERIORITY_OR_EQUIVALENCE|(GMTMenACWY/GMTMenjugate \> 0.5).|Ratio|8.1|||||TWO_SIDED|95.0|6.35|10.0|||ANOVA|||For comparison of the GMTs (one month postvaccination), MenACWY was determined to be non-inferior to MenC if the lower limit of the two-sided 95% CI for the ratio of the MenACWY to MenC GMTs for serogroup C was greater than 0.5.||10|6.35|
72382386|NCT00667602|144273597|NON_INFERIORITY_OR_EQUIVALENCE|(PConcomitant Vaccine + MenACWY - PConcomitant Vaccine+MenC).|Percentage difference|0.0|||||TWO_SIDED|95.0|-2.0|2.0|||Miettinen and Nurminen|Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.||Immunogenicity of DTPa-IPV-HepB-Hib (Anti-Diptheria Toxin ≥0.1 IU/mL, one month postvaccination) given concomitantly with two dose of MenACWY was considered non-inferior to DTPa-IPV-HepB-Hib given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%.||2|-2|
72382387|NCT00667602|144273597|NON_INFERIORITY_OR_EQUIVALENCE|(PConcomitant Vaccine + MenACWY - PConcomitant Vaccine+MenC).|Percentage difference|0.0|||||TWO_SIDED|95.0|-2.0|2.0|||Miettinen and Nurminen|Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.||Immunogenicity of DTPa-IPV-HepB-Hib (Anti-Diptheria Toxin ≥0.1 IU/mL, one month postvaccination) given concomitantly with one dose of MenACWY was considered non-inferior to DTPa-IPV-HepB-Hib given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%.||2|-2|
72382388|NCT00667602|144273597|NON_INFERIORITY_OR_EQUIVALENCE|(PConcomitant Vaccine + MenACWY - PConcomitant Vaccine+MenC).|Percentage difference|1.0|||||TWO_SIDED|95.0|-3.0|5.0|||Miettinen and Nurminen|Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.||Immunogenicity of DTPa-IPV-HepB-Hib (Anti-Diptheria Toxin ≥1.0 IU/mL, one month postvaccination) given concomitantly with two dose of MenACWY was considered non-inferior to DTPa-IPV-HepB-Hib given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%.||5|-3|
72382389|NCT00667602|144273597|NON_INFERIORITY_OR_EQUIVALENCE|(PConcomitant Vaccine + MenACWY - PConcomitant Vaccine+MenC).|Percentage difference|0.0|||||TWO_SIDED|95.0|-3.0|4.0|||Miettinen and Nurminen|Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.||Immunogenicity of DTPa-IPV-HepB-Hib (Anti-Diptheria Toxin ≥1.0 IU/mL, one month postvaccination) given concomitantly with one dose of MenACWY was considered non-inferior to DTPa-IPV-HepB-Hib given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%.||4|-3|
72382390|NCT00667602|144273597|NON_INFERIORITY_OR_EQUIVALENCE|(PConcomitant Vaccine + MenACWY - PConcomitant Vaccine+MenC).|Percentage difference|0.0|||||TWO_SIDED|95.0|-2.0|2.0|||Miettinen and Nurminen|Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.||Immunogenicity of DTPa-IPV-HepB-Hib (Anti-Tetanus Toxin ≥ 0.1 IU/mL, one month postvaccination) given concomitantly with two dose of MenACWY was considered non-inferior to DTPa-IPV-HepB-Hib given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%.||2|-2|
72382391|NCT00667602|144273597|NON_INFERIORITY_OR_EQUIVALENCE|(PConcomitant Vaccine + MenACWY - PConcomitant Vaccine+MenC).|Percentage difference|0.0|||||TWO_SIDED|95.0|-2.0|2.0|||Miettinen and Nurminen|Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.||Immunogenicity of DTPa-IPV-HepB-Hib (Anti-Tetanus Toxin ≥ 0.1 IU/mL, one month postvaccination) given concomitantly with one dose of MenACWY was considered non-inferior to DTPa-IPV-HepB-Hib given concomitantly with one dose of MenC, for any of the antigens, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%.||2|-2|
72434468|NCT01362491|144382036|SUPERIORITY_OR_OTHER||Difference in proportion|46.68|||<|0.001|TWO_SIDED|95.0|30.43|62.93||p-value was calculated using CMH test which was adjusted for baseline Pain Severity Rating (PSR) and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||2 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||62.93|30.43|<0.001
72618677|NCT01026038|144768107|SUPERIORITY_OR_OTHER||GMC ratio|1.24|||||TWO_SIDED|95.0|0.75|2.05||||||Serotype 19A: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||2.05|0.75|
72557418|NCT00205777|144645419|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.551||||0.035|TWO_SIDED|95.0|0.324|0.937|||Log Rank|||At Least 1 Prevalent Fracture: P value was calculated using stratified log-rank test. Hazard ratio (Bazedoxifene 20 mg \[Core+SE I\] versus Placebo \[Core+SE I+SE II\]) based on a Cox proportional hazards regression model was presented along with 95% CIs.||0.937|0.324|0.035
72382392|NCT00667602|144273597|NON_INFERIORITY_OR_EQUIVALENCE|(PConcomitant Vaccine + MenACWY - PConcomitant Vaccine+MenC).|Percentage difference|-2.0|||||TWO_SIDED|95.0|-6.0|3.0|||Miettinen and Nurminen|Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.||Immunogenicity of DTPa-IPV-HepB-Hib (Anti-Tetanus Toxin ≥ 1.0 IU/mL, one month postvaccination) given concomitantly with two dose of MenACWY was considered non-inferior to DTPa-IPV-HepB-Hib given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%.||3|-6|
72382393|NCT00667602|144273597|NON_INFERIORITY_OR_EQUIVALENCE|(PConcomitant Vaccine + MenACWY - PConcomitant Vaccine+MenC).|Percentage difference|-1.0|||||TWO_SIDED|95.0|-6.0|3.0|||Miettinen and Nurminen|Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.||Immunogenicity of DTPa-IPV-HepB-Hib (Anti-Tetanus Toxin ≥ 1.0 IU/mL, one month postvaccination) given concomitantly with one dose of MenACWY was considered non-inferior to DTPa-IPV-HepB-Hib given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%.||3|-6|
72382394|NCT00667602|144273597|NON_INFERIORITY_OR_EQUIVALENCE|(PConcomitant Vaccine + MenACWY - PConcomitant Vaccine+MenC).|Percentage difference|1.0|||||TWO_SIDED|95.0|-2.0|4.0|||Miettinen and Nurminen|Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.||Immunogenicity of DTPa-IPV-HepB-Hib (polio 1, one month postvaccination), given concomitantly with two dose of MenACWY was considered non-inferior to DTPa-IPV-HepB-Hib given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%.||4|-2|
72382395|NCT00667602|144273597|NON_INFERIORITY_OR_EQUIVALENCE|(PConcomitant Vaccine + MenACWY - PConcomitant Vaccine+MenC).|Percentage difference|1.0|||||TWO_SIDED|95.0|-2.0|4.0|||Miettinen and Nurminen|Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.||Immunogenicity of DTPa-IPV-HepB-Hib (polio 1, one month postvaccination) given concomitantly with one dose of MenACWY was considered non-inferior to DTPa-IPV-HepB-Hib given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%.||4|-2|
72382396|NCT00667602|144273597|NON_INFERIORITY_OR_EQUIVALENCE|(PConcomitant Vaccine + MenACWY - PConcomitant Vaccine+MenC).|Percentage difference|0.0|||||TWO_SIDED|95.0|-2.0|3.0|||Miettinen and Nurminen|Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.||Immunogenicity of DTPa-IPV-HepB-Hib (polio 2, one month postvaccination) given concomitantly with two dose of MenACWY was considered non-inferior to DTPa-IPV-HepB-Hib given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%.||3|-2|
72382397|NCT00667602|144273597|NON_INFERIORITY_OR_EQUIVALENCE|(PConcomitant Vaccine + MenACWY - PConcomitant Vaccine+MenC).|Percentage difference|-1.0|||||TWO_SIDED|95.0|-3.0|2.0|||Miettinen and Nurminen|Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.||Immunogenicity of DTPa-IPV-HepB-Hib (polio 2, one month postvaccination) given concomitantly with one dose of MenACWY was considered non-inferior to DTPa-IPV-HepB-Hib given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%.||2|-3|
72382398|NCT00667602|144273597|NON_INFERIORITY_OR_EQUIVALENCE|(PConcomitant Vaccine + MenACWY - PConcomitant Vaccine+MenC).|Percentage difference|0.0|||||TWO_SIDED|95.0|-3.0|3.0|||Miettinen and Nurminen|Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.||Immunogenicity of DTPa-IPV-HepB-Hib (polio 3, one month postvaccination) given concomitantly with two dose of MenACWY was considered non-inferior to DTPa-IPV-HepB-Hib given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%.||3|-3|
72382399|NCT00667602|144273597|NON_INFERIORITY_OR_EQUIVALENCE|(PConcomitant Vaccine + MenACWY - PConcomitant Vaccine+MenC).|Percentage Difference|0.0|||||TWO_SIDED|95.0|-2.0|3.0||Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.|Miettinen and Nurminen|||Immunogenicity of DTPa-IPV-HepB-Hib (Polio 3, one month postvaccination) given concomitantly with one dose of MenACWY was considered non-inferior to DTPa-IPV-HepB-Hib given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%.||3|-2|
72382400|NCT00667602|144273597|NON_INFERIORITY_OR_EQUIVALENCE|(PConcomitant Vaccine + MenACWY - PConcomitant Vaccine+MenC).|Percentage Difference|0.0|||||TWO_SIDED|95.0|-2.0|2.0||Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.|Miettinen and Nurminen|||Immunogenicity of DTPa-IPV-HepB-Hib (Anti- PRP ≥ 0.15 μg/mL, one month postvaccination) given concomitantly with two dose of MenACWY was considered non-inferior to DTPa-IPV-HepB-Hib given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%.||2|-2|
72618678|NCT01026038|144768107|SUPERIORITY_OR_OTHER||GMC ratio|0.48|||||TWO_SIDED|95.0|0.26|0.89||||||Serotype 19A: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||0.89|0.26|
72618679|NCT01026038|144768108|SUPERIORITY_OR_OTHER||GMT Ratio|0.2|||||TWO_SIDED|95.0|0.04|0.73||||||Serotype 4: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||0.73|0.04|
72557419|NCT00205777|144645419|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.624||||0.07|TWO_SIDED|95.0|0.373|1.045|||Log Rank|||At Least 1 Prevalent Fracture: P value was calculated using stratified log-rank test. Hazard ratio (Bazedoxifene 40 mg \[Core\] versus Placebo \[Core+SE I+SE II\]) based on a Cox proportional hazards regression model was presented along with 95% CIs.||1.045|0.373|0.070
72382401|NCT00667602|144273597|NON_INFERIORITY_OR_EQUIVALENCE|(PConcomitant Vaccine + MenACWY - PConcomitant Vaccine+MenC).|Percentage Difference|0.0|||||TWO_SIDED|95.0|-2.0|2.0|||Miettinen and Nurminen|Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.||Immunogenicity of DTPa-IPV-HepB-Hib (Anti- PRP ≥ 0.15 μg/mL, one month postvaccination) given concomitantly with one dose of MenACWY was considered non-inferior to DTPa-IPV-HepB-Hib given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%.||2|-2|
72382402|NCT00667602|144273597|NON_INFERIORITY_OR_EQUIVALENCE|(PConcomitant Vaccine + MenACWY - PConcomitant Vaccine+MenC).|Percentage Difference|1.0|||||TWO_SIDED|95.0|-2.0|4.0||Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.|Miettinen and Nurminen|||Immunogenicity of DTPa-IPV-HepB-Hib (Anti- PRP ≥ 1.0 μg/mL, one month postvaccination) given concomitantly with two dose of MenACWY was considered non-inferior to DTPa-IPV-HepB-Hib given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%.||4|-2|
72382403|NCT00667602|144273597|NON_INFERIORITY_OR_EQUIVALENCE|PConcomitant Vaccine + MenACWY - PConcomitant Vaccine+MenC).|Percentage Difference|-1.0|||||TWO_SIDED|95.0|-4.0|2.0|||Miettinen and Nurminen|Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.||Immunogenicity of DTPa-IPV-HepB-Hib (Anti- PRP ≥ 1.0 μg/mL, one month postvaccination) given concomitantly with one dose of MenACWY was considered non-inferior to DTPa-IPV-HepB-Hib given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%.||2|-4|
72382404|NCT00667602|144273597|NON_INFERIORITY_OR_EQUIVALENCE|(PConcomitant Vaccine + MenACWY - PConcomitant Vaccine+MenC).|Percentage Difference|0.0|||||TWO_SIDED|95.0|-3.0|3.0|||Miettinen and Nurminen|Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.||Immunogenicity of DTPa-IPV-HepB-Hib (Hep B, one month postvaccination) given concomitantly with two dose of MenACWY was considered non-inferior to DTPa-IPV-HepB-Hib given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%.||3|-3|
72382405|NCT00667602|144273597|NON_INFERIORITY_OR_EQUIVALENCE|(PConcomitant Vaccine + MenACWY - PConcomitant Vaccine+MenC)|Percentage Difference|-1.0|||||TWO_SIDED|95.0|-4.0|3.0|||Miettinen and Nurminen|Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.||Immunogenicity of DTPa-IPV-HepB-Hib (Hep B, one month postvaccination) given concomitantly with one dose of MenACWY was considered non-inferior to DTPa-IPV-HepB-Hib given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%.||3|-4|
72382406|NCT00667602|144273598|NON_INFERIORITY_OR_EQUIVALENCE|(PConcomitant Vaccine + MenACWY - PConcomitant Vaccine+MenC).|Percentage difference|-5.0|||||TWO_SIDED|95.0|-13.0|3.0|||Miettinen and Nurminen|Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.||Immunogenicity of PCV7 (PNC4, one month postvaccination)given concomitantly with one dose of MenACWY was considered non-inferior to PCV7 given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%.||3|-13|
72382407|NCT00667602|144273598|NON_INFERIORITY_OR_EQUIVALENCE|(PConcomitant Vaccine + MenACWY - PConcomitant Vaccine+MenC).|Percentage difference|-6.0|||||TWO_SIDED|95.0|-12.0|-1.0|||Miettinen and Nurminen|Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.||Immunogenicity of PCV7(PNC 6B, one month postvaccination) given concomitantly with one dose of MenACWY was considered non-inferior to PCV7 given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%.||-1|-12|
72382408|NCT00667602|144273598|NON_INFERIORITY_OR_EQUIVALENCE|(PConcomitant Vaccine + MenACWY-CRM - PConcomitant Vaccine + MenC).|Percentage difference|-5.0|||||TWO_SIDED|95.0|-11.0|2.0|||Miettinen and Nurminen|Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.||Immunogenicity of PCV7(PnC 9V, one month postvaccination) given concomitantly with MenACWY-CRM197 or MenC was considered non-inferior, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than -10%.||2|-11|
72382409|NCT00667602|144273598|NON_INFERIORITY_OR_EQUIVALENCE|(PConcomitant Vaccine + MenACWY - PConcomitant Vaccine+MenC).|Percentage difference|0.0|||||TWO_SIDED|95.0|-3.0|3.0|||Miettinen and Nurminen|Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.||Immunogenicity of PCV7 (PNC 14, one month postvaccination) given concomitantly with one dose of MenACWY was considered non-inferior to PCV7 given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%.||3|-3|
72434469|NCT01362491|144382036|SUPERIORITY_OR_OTHER||Difference in proportion|47.59|||<|0.001|TWO_SIDED|95.0|31.35|63.83||p-value was calculated using CMH test which was adjusted for baseline Pain Severity Rating (PSR) and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||2 hours: Treatment difference \[Ibuprofen (Motrin IB) - placebo\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||63.83|31.35|<0.001
72382410|NCT00667602|144273598|NON_INFERIORITY_OR_EQUIVALENCE|(PConcomitant Vaccine + MenACWY - PConcomitant Vaccine+MenC).|Percentage difference|-10.0|||||TWO_SIDED|95.0|-19.0|-2.0|||Miettinen and Nurminen|Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.||Immunogenicity of PCV7( PNC 18C, one month postvaccination) given concomitantly with one dose of MenACWY was considered non-inferior to PCV7 given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%.||-2|-19|
72382411|NCT00667602|144273598|NON_INFERIORITY_OR_EQUIVALENCE|(PConcomitant Vaccine + MenACWY - PConcomitant Vaccine+MenC).|Percentage difference|-10.0|||||TWO_SIDED|95.0|-17.0|-2.0|||Miettinen and Nurminen|Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.||Immunogenicity of PCV7 (PNC 19F, one month postvaccination), given concomitantly with one dose of MenACWY was considered non-inferior to PCV7 given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%.||-2|-17|
72434470|NCT01362491|144382036|SUPERIORITY_OR_OTHER||Difference in proportion|-0.72||||0.889|TWO_SIDED|95.0|-10.89|9.45||p-value was calculated using CMH test which was adjusted for baseline Pain Severity Rating (PSR) and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||2 hours: Treatment difference \[Ibuprofen Sodium - Ibuprofen (Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||9.45|-10.89|0.889
72434471|NCT01362491|144382036|SUPERIORITY_OR_OTHER||Difference in proportion|40.26|||<|0.001|TWO_SIDED|95.0|23.85|56.68||p-value was calculated using CMH test which was adjusted for baseline Pain Severity Rating (PSR) and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||3 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||56.68|23.85|<0.001
72434472|NCT01362491|144382036|SUPERIORITY_OR_OTHER||Difference in proportion|41.19|||<|0.001|TWO_SIDED|95.0|24.78|57.59||p-value was calculated using CMH test which was adjusted for baseline Pain Severity Rating (PSR) and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||3 hours: Treatment difference \[Ibuprofen (Motrin IB) - placebo\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||57.59|24.78|<0.001
72434473|NCT01362491|144382036|SUPERIORITY_OR_OTHER||Difference in proportion|-0.72||||0.889|TWO_SIDED|95.0|-10.89|9.45||p-value was calculated using CMH test which was adjusted for baseline Pain Severity Rating (PSR) and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||3 hours: Treatment difference \[Ibuprofen Sodium - Ibuprofen (Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||9.45|-10.89|0.889
72434474|NCT01362491|144382037|SUPERIORITY_OR_OTHER||Difference in proportion|18.58||||0.002|TWO_SIDED|95.0|10.43|26.73||p-value was calculated using CMH test which was adjusted for baseline Pain Severity Rating (PSR) and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||0.5 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||26.73|10.43|0.002
72434475|NCT01362491|144382037|SUPERIORITY_OR_OTHER||Difference in proportion|7.8||||0.055|TWO_SIDED|95.0|2.14|13.46||p-value was calculated using CMH test which was adjusted for baseline Pain Severity Rating (PSR) and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||0.5 hours: Treatment difference \[Ibuprofen (Motrin IB) - placebo\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||13.46|2.14|0.055
72434476|NCT01362491|144382037|SUPERIORITY_OR_OTHER||Difference in proportion|10.91||||0.033|TWO_SIDED|95.0|0.98|20.83||p-value was calculated using CMH test which was adjusted for baseline Pain Severity Rating (PSR) and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||0.5 hours: Treatment difference \[Ibuprofen Sodium - Ibuprofen (Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||20.83|0.98|0.033
72618680|NCT01026038|144768108|SUPERIORITY_OR_OTHER||GMT Ratio|0.2|||||TWO_SIDED|95.0|0.04|0.64||||||Serotype 4: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||0.64|0.04|
72434477|NCT01362491|144382037|SUPERIORITY_OR_OTHER||Difference in proportion|62.03|||<|0.001|TWO_SIDED|95.0|48.65|75.41||p-value was calculated using CMH test which was adjusted for baseline Pain Severity Rating (PSR) and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1 hour: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||75.41|48.65|<0.001
72434478|NCT01362491|144382037|SUPERIORITY_OR_OTHER||Difference in proportion|59.44|||<|0.001|TWO_SIDED|95.0|45.69|73.19||p-value was calculated using CMH test which was adjusted for baseline Pain Severity Rating (PSR) and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1 hour: Treatment difference \[Ibuprofen (Motrin IB) - placebo\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||73.19|45.69|<0.001
72434479|NCT01362491|144382037|SUPERIORITY_OR_OTHER||Difference in proportion|2.96||||0.642|TWO_SIDED|95.0|-9.52|15.44||p-value was calculated using CMH test which was adjusted for baseline Pain Severity Rating (PSR) and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1 hour: Treatment difference \[Ibuprofen Sodium - Ibuprofen (Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||15.44|-9.52|0.642
72434480|NCT01362491|144382037|SUPERIORITY_OR_OTHER||Difference in proportion|40.26|||<|0.001|TWO_SIDED|95.0|23.85|56.68||p-value was calculated using CMH test which was adjusted for baseline Pain Severity Rating (PSR) and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||2 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||56.68|23.85|<0.001
72434481|NCT01362491|144382037|SUPERIORITY_OR_OTHER||Difference in proportion|41.19|||<|0.001|TWO_SIDED|95.0|24.78|57.59||p-value was calculated using CMH test which was adjusted for baseline Pain Severity Rating (PSR) and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||2 hours: Treatment difference \[Ibuprofen (Motrin IB) - placebo\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||57.59|24.78|<0.001
72434482|NCT01362491|144382037|SUPERIORITY_OR_OTHER||Difference in proportion|-0.72||||0.889|TWO_SIDED|95.0|-10.89|9.45||p-value was calculated using CMH test which was adjusted for baseline Pain Severity Rating (PSR) and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||2 hours: Treatment difference \[Ibuprofen Sodium - Ibuprofen (Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||9.45|-10.89|0.889
72434483|NCT01362491|144382037|SUPERIORITY_OR_OTHER||Difference in proportion|40.26|||<|0.001|TWO_SIDED|95.0|23.85|56.68||p-value was calculated using CMH test which was adjusted for baseline Pain Severity Rating (PSR) and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||3 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||56.68|23.85|<0.001
72434484|NCT01362491|144382037|SUPERIORITY_OR_OTHER||Difference in proportion|41.19|||<|0.001|TWO_SIDED|95.0|24.78|57.59||p-value was calculated using CMH test which was adjusted for baseline Pain Severity Rating (PSR) and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||3 hours: Treatment difference \[Ibuprofen (Motrin IB) - placebo\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||57.59|24.78|<0.001
72434485|NCT01362491|144382037|SUPERIORITY_OR_OTHER||Difference in proportion|-0.72||||0.889|TWO_SIDED|95.0|-10.89|9.45||p-value was calculated using CMH test which was adjusted for baseline Pain Severity Rating (PSR) and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||3 hours: Treatment difference \[Ibuprofen Sodium - Ibuprofen (Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||9.45|-10.89|0.889
72434486|NCT01362491|144382040|SUPERIORITY_OR_OTHER||Difference in proportion|3.21||||0.389|TWO_SIDED|95.0|-3.12|9.55||p-value was calculated using CMH test which was adjusted for baseline Pain Severity Rating (PSR) and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||2 hours: Treatment difference (Ibuprofen Sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||9.55|-3.12|0.389
72434487|NCT01362491|144382040|SUPERIORITY_OR_OTHER||Difference in proportion|2.35||||0.49|TWO_SIDED|95.0|-3.69|8.39||p-value was calculated using CMH test which was adjusted for baseline Pain Severity Rating (PSR) and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||2 hours: Treatment difference \[Ibuprofen (Motrin IB) - placebo\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||8.39|-3.69|0.490
72434488|NCT01362491|144382040|SUPERIORITY_OR_OTHER||Difference in proportion|0.98||||0.764|TWO_SIDED|95.0|-5.45|7.41||p-value was calculated using CMH test which was adjusted for baseline Pain Severity Rating (PSR) and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||2 hours: Treatment difference \[Ibuprofen Sodium - Ibuprofen (Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||7.41|-5.45|0.764
72434489|NCT01362491|144382040|SUPERIORITY_OR_OTHER||Difference in proportion|28.71|||<|0.001|TWO_SIDED|95.0|15.72|41.7||p-value was calculated using CMH test which was adjusted for baseline Pain Severity Rating (PSR) and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||3 hours: Treatment difference (Ibuprofen Sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||41.70|15.72|<0.001
72434490|NCT01362491|144382040|SUPERIORITY_OR_OTHER||Difference in proportion|29.37|||<|0.001|TWO_SIDED|95.0|16.19|42.56||p-value was calculated using CMH test which was adjusted for baseline Pain Severity Rating (PSR) and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||3 hours: Treatment difference \[Ibuprofen (Motrin IB) - placebo\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||42.56|16.19|<0.001
72434491|NCT01362491|144382040|SUPERIORITY_OR_OTHER||Difference in proportion|-0.93||||0.898|TWO_SIDED|95.0|-15.22|13.36||p-value was calculated using CMH test which was adjusted for baseline Pain Severity Rating (PSR) and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||3 hours: Treatment difference \[Ibuprofen Sodium - Ibuprofen (Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||13.36|-15.22|0.898
72434492|NCT01257503|144382054|SUPERIORITY_OR_OTHER|||||||0.86|TWO_SIDED||||||Regression, Linear|generalized estimating equations used to account for multiple doses in same participant||change in runny nose||||.86
72434493|NCT01257503|144382054|SUPERIORITY_OR_OTHER|||||||0.89|TWO_SIDED||||||Regression, Linear|generalized estimating equations used to account for multiple doses in single participant||change in sneeze||||.89
72434494|NCT01257503|144382054|SUPERIORITY_OR_OTHER|||||||0.45|TWO_SIDED||||||Regression, Linear|generalized estimating equations used to account for multiple doses in single participant||change in cough||||.45
72434495|NCT01257503|144382054|SUPERIORITY_OR_OTHER|||||||0.82|TWO_SIDED||||||Regression, Linear|generalized estimating equations used to account for multiple doses in single participant||change in congestion||||.82
72434496|NCT01257503|144382055|SUPERIORITY_OR_OTHER|||||||0.61|TWO_SIDED||||||Regression, Linear|Generalized estimating equations used to account for multiple doses in single participant.||change in irritability||||.61
72434497|NCT01257503|144382055|SUPERIORITY_OR_OTHER|||||||0.97|TWO_SIDED||||||Regression, Linear|Generalized estimating equations used to account for multiple doses in single participant.||change in lethargy||||.97
72434498|NCT01257503|144382055|SUPERIORITY_OR_OTHER|||||||0.79|TWO_SIDED||||||Regression, Linear|Generalized estimating equations used to account for multiple doses in single participant.||change in fussiness||||.79
72434499|NCT01257503|144382055|SUPERIORITY_OR_OTHER|||||||0.81|TWO_SIDED||||||Regression, Linear|Generalized estimating equations used to account for multiple doses in single participant.||change in appetite||||.81
72557420|NCT00205777|144645419|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.085||||0.79|TWO_SIDED|95.0|0.605|1.947|||Log Rank|||At Least 1 Prevalent Fracture: P value was calculated using stratified log-rank test. Hazard ratio (Bazedoxifene 40 mg \[Core\] versus Raloxifene 60 mg \[Core\]) based on a Cox proportional hazards regression model was presented along with 95% CIs.||1.947|0.605|0.79
72434500|NCT01257503|144382056|SUPERIORITY_OR_OTHER|||||||0.16|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||functional status day 1||||.16
72557421|NCT00205777|144645419|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.959||||0.99|TWO_SIDED|95.0|0.527|1.743|||Log Rank|||At Least 1 Prevalent Fracture: P value was calculated using stratified log-rank test. Hazard ratio (Bazedoxifene 20 mg \[Core+SE I\] versus Raloxifene 60 mg \[Core\]) based on a Cox proportional hazards regression model was presented along with 95% CIs.||1.743|0.527|0.99
72434501|NCT01257503|144382056|SUPERIORITY_OR_OTHER|||||||0.7|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||functional status day 2||||.70
72434502|NCT01257503|144382056|SUPERIORITY_OR_OTHER|||||||0.77|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||functional status day 3||||.77
72434503|NCT01257503|144382056|SUPERIORITY_OR_OTHER|||||||0.41|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||functional status at 7-10 day follow-up||||.41
72434504|NCT01257503|144382057|SUPERIORITY_OR_OTHER|||||||0.1|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||health status day 1||||.10
72434505|NCT01257503|144382057|SUPERIORITY_OR_OTHER|||||||0.28|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||health status day 2||||.28
72434506|NCT01257503|144382057|SUPERIORITY_OR_OTHER|||||||0.26|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||health status day 3||||.26
72434507|NCT01257503|144382057|SUPERIORITY_OR_OTHER|||||||0.88|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||health status at follow-up||||.88
72434508|NCT01257503|144382058|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||cold score day 1 assessment 1||||.02
72434509|NCT01257503|144382058|SUPERIORITY_OR_OTHER|||||||0.01|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||cold score day 1 assessment 2||||.01
72434510|NCT01257503|144382058|SUPERIORITY_OR_OTHER|||||||0.25|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||day 2 assessment 1||||.25
72434511|NCT01257503|144382058|SUPERIORITY_OR_OTHER|||||||0.15|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||cold score day 2 assessment 2||||.15
72434512|NCT01257503|144382058|SUPERIORITY_OR_OTHER|||||||0.88|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||cold score day 3 assessment 1||||.88
72557422|NCT00205777|144645419|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.882||||0.78|TWO_SIDED|95.0|0.488|1.593|||Log Rank|||At Least 1 Prevalent Fracture: P value was calculated using stratified log-rank test. Hazard ratio (Bazedoxifene 20 mg \[Core+SE I\] versus Bazedoxifene 40 mg \[Core\]) based on a Cox proportional hazards regression model was presented along with 95% CIs.||1.593|0.488|0.78
72618681|NCT01026038|144768108|SUPERIORITY_OR_OTHER||GMT Ratio|1.0|||||TWO_SIDED|95.0|0.19|5.46||||||Serotype 4: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||5.46|0.19|
72434513|NCT01257503|144382058|SUPERIORITY_OR_OTHER|||||||0.35|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||cold score day 3 assessment 2||||.35
72434514|NCT01257503|144382058|SUPERIORITY_OR_OTHER|||||||0.36|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||cold score at 7-10 day follow-up||||.36
72434515|NCT01090024|144382061|SUPERIORITY|One-sided p-value testing superiority of BI 671800 vs placebo with 2.5% alpha.|Adjusted means difference|0.083|STANDARD_ERROR_OF_MEAN|0.624||0.4473|TWO_SIDED|95.0|-1.147|1.313|||Mixed effect model||Adjusted means difference of BI 671800 200 mg BID (D) vs Placebo (A).|Restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM) with terms for baseline, treatment and period as fixed effects and patient as a random effect was used. A compound symmetry covariance structure was used.||1.313|-1.147|0.4473
72434516|NCT01090024|144382061|SUPERIORITY|One-sided p-value testing superiority of BI 671800 vs placebo with 2.5% alpha.|Adjusted means difference|0.67|STANDARD_ERROR_OF_MEAN|0.625||0.1426|TWO_SIDED|95.0|-0.563|1.903|||Mixed effect model||Adjusted means difference of BI 671800 400 mg PM QD (C) vs Placebo (A).|Restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM) with terms for baseline, treatment and period as fixed effects and patient as a random effect was used. A compound symmetry covariance structure was used.||1.903|-0.563|0.1426
72434517|NCT01090024|144382061|SUPERIORITY|One-sided p-value testing superiority of BI 671800 vs placebo with 2.5% alpha.|Adjusted means difference|0.281|STANDARD_ERROR_OF_MEAN|0.611||0.3231|TWO_SIDED|95.0|-0.924|1.486|||Mixed effect model||Adjusted means difference of BI 671800 400 mg AM QD (B) vs Placebo (A).|Restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM) with terms for baseline, treatment and period as fixed effects and patient as a random effect was used. A compound symmetry covariance structure was used.||1.486|-0.924|0.3231
72434518|NCT01090024|144382062|SUPERIORITY|One-sided p-value testing superiority of BI 671800 vs placebo with 2.5% alpha.|Adjusted means difference|-0.056|STANDARD_ERROR_OF_MEAN|0.063||0.1879|TWO_SIDED|95.0|-0.18|0.068|||Mixed effect model||Adjusted means difference of BI 671800 200 mg BID (D) vs Placebo (A).|Restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM) with terms for baseline, treatment and period as fixed effects and patient as a random effect was used. A autoregressive covariance structure was used.||0.068|-0.180|0.1879
72434519|NCT01090024|144382062|SUPERIORITY|One-sided p-value testing superiority of BI 671800 vs placebo with 2.5% alpha.|Adjusted means difference|-0.026|STANDARD_ERROR_OF_MEAN|0.063||0.3384|TWO_SIDED|95.0|-0.151|0.098|||Mixed effect model||Adjusted means difference of BI 671800 400 mg PM QD (C) vs Placebo (A).|Restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM) with terms for baseline, treatment and period as fixed effects and patient as a random effect was used. A autoregressive covariance structure was used.||0.098|-0.151|0.3384
72434520|NCT01090024|144382062|SUPERIORITY|One-sided p-value testing superiority of BI 671800 vs placebo with 2.5% alpha.|Adjusted means difference|-0.093|STANDARD_ERROR_OF_MEAN|0.062||0.067|TWO_SIDED|95.0|-0.214|0.029|||Mixed effect model||Adjusted means difference of BI 671800 400 mg AM QD (B) vs Placebo (A).|Restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM) with terms for baseline, treatment and period as fixed effects and patient as a random effect was used. A autoregressive covariance structure was used.||0.029|-0.214|0.0670
72434521|NCT02380742|144382071|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.87|STANDARD_ERROR_OF_MEAN|0.47||0.02|TWO_SIDED||||||ANCOVA|||The null hypothesis was that patients' pain scores at removal were the same between the lidocaine and placebo groups after controlling for baseline pain.||||.02
72434522|NCT02380742|144382072|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.96|STANDARD_ERROR_OF_MEAN|0.87||0.03|TWO_SIDED||||||ANCOVA|||The null hypothesis was that patients' pain scores at removal were the same between the lidocaine and placebo groups after controlling for investigator training and pessary type.||||.03
72434523|NCT02380742|144382073|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.811|STANDARD_ERROR_OF_MEAN|0.83||0.03|TWO_SIDED||||||ANCOVA|||The null hypothesis was that patients' pain scores at removal were the same between the lidocaine and placebo groups after controlling for baseline pain and patient age.||||.03
72434524|NCT02380742|144382074|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.07|STANDARD_ERROR_OF_MEAN|0.63||0.09|TWO_SIDED||||||ANCOVA|||The null hypothesis was that patients' pain scores at insertion were the same between the lidocaine and placebo groups after controlling for baseline pain.||||.09
72434525|NCT00516503|144382082|SUPERIORITY_OR_OTHER|||||||0.9|||||||Wilcoxon (Mann-Whitney)|||||||0.90
72434526|NCT00516503|144382083|SUPERIORITY_OR_OTHER|||||||0.5|||||||Wilcoxon (Mann-Whitney)|||||||0.50
72434527|NCT00516503|144382084|SUPERIORITY_OR_OTHER|||||||0.5|||||||Wilcoxon (Mann-Whitney)|||||||0.50
72434528|NCT01451814|144382105|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.91||||0.22|TWO_SIDED|95.0|0.67|5.48|||Chi-squared|||||5.48|0.67|.22
72434529|NCT01451814|144382106|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.3||||0.06|TWO_SIDED|95.0|0.84|22.1|||Chi-squared|||||22.1|0.84|.06
72434530|NCT01451814|144382107|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.0||||0.18|TWO_SIDED|95.0|0.56|16.11|||Chi-squared|||||16.11|0.56|.18
72434531|NCT02131324|144382122|EQUIVALENCE|Two-sided hypothesis testing was conducted for all the tests. Resulting p-values less than 0.05 were considered statistically significant unless noted otherwise. No adjustments of p values were made for multiple comparisons.||||||0.086|||||||ANOVA|||Two-sided hypothesis testing was conducted for all the tests. Resulting p-values less than 0.05 were considered statistically significant unless noted otherwise. No adjustments of p values were made for multiple comparisons.||||0.086
72434532|NCT00420316|144382130|SUPERIORITY_OR_OTHER||Percent reduction|34.3||||0.691|TWO_SIDED|95.0|-348.7|88.9|||Fisher Exact|||Vaccine efficacy with respect to any rotavirus gastroenteritis (RV GE) caused by the circulating wild-type rotavirus strain. Vaccine efficacy (VE) was defined as the percent reduction in the frequency of the relevant outcome variable in vaccinated subjects compared with those subjects who received placebo.||88.9|-348.7|0.691
72557423|NCT00205777|144645419|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.574||||0.036|TWO_SIDED|95.0|0.34|0.968|||Log Rank|||At Least 1 Prevalent Fracture: P value was calculated using stratified log-rank test. Hazard ratio (Raloxifene 60 mg \[Core\] versus Placebo \[Core+SE I+SE II\]) based on a Cox proportional hazards regression model was presented along with 95% CIs.||0.968|0.340|0.036
72434533|NCT00420316|144382131|SUPERIORITY_OR_OTHER||Percent reduction|50.7||||0.551|TWO_SIDED|95.0|-3769.6|99.4|||Fisher Exact|||Vaccine efficacy with respect to severe rotavirus gastroenteritis (RVGE) caused by the circulating wild-type rotavirus strain was assessed. Vaccine efficacy (VE) was defined as the percent reduction in the frequency of the relevant outcome variable in vaccinated subjects compared with those subjects who have received placebo.||99.4|-3769.6|0.551
72434534|NCT00420316|144382133|SUPERIORITY_OR_OTHER||Percent reduction|100.0||||0.33|TWO_SIDED|95.0|-1822.5|100.0|||Fisher Exact|||Vaccine efficacy with respect to severe rotavirus gastroenteritis (RVGE) caused by the wild-type rotavirus strain of serotype G1. Vaccine efficacy (VE) was defined as the percent reduction in the frequency of the relevant outcome variable in vaccinated subjects compared with those subjects who received placebo.||100|-1822.5|0.33
72557424|NCT00205777|144645420|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.61||||0.097|TWO_SIDED|95.0|0.339|1.099|||Log Rank|||No Prevalent Fractures: P value was calculated using stratified log-rank test. Hazard ratio (Bazedoxifene 20 mg \[Core+SE I\] versus Placebo \[Core+SE I+SE II\]) based on a Cox proportional hazards regression model was presented along with 95% CIs.||1.099|0.339|0.097
72434535|NCT00420316|144382134|SUPERIORITY_OR_OTHER||Percent reduction|-97.2||||1|TWO_SIDED|95.0|-9610.8|80.5|||Fisher Exact|||Vaccine efficacy with respect to any rotavirus gastroenteritis (RVGE) caused by the wild-type rotavirus strain of non-G1 serotype. Vaccine efficacy (VE) was defined as the percent reduction in the frequency of the relevant outcome variable in vaccinated subjects compared with those subjects who received placebo.||80.5|-9610.8|1
72434536|NCT00420316|144382135|SUPERIORITY_OR_OTHER||Percent reduction|0.0||||1|TWO_SIDED|95.0|0.0|98.7|||Fisher Exact|||Vaccine efficacy with respect to severe rotavirus gastroenteritis (RVGE) caused by the wild-type rotavirus strain of non-G1 serotype was assessed. Vaccine efficacy (VE) was defined as the percent reduction in the frequency of the relevant outcome variable in vaccinated subjects compared with those subjects who received placebo.||98.7|0|1
72434537|NCT00420316|144382136|SUPERIORITY_OR_OTHER||Percent reduction|-23.2||||0.817|TWO_SIDED|95.0|-287.7|54.8|||Fisher Exact|||Vaccine efficacy with respect to severe gastroenteritis (GE) was assessed. Vaccine efficacy (VE) was defined as the percent reduction in the frequency of the relevant outcome variable in vaccinated subjects compared with those subjects who received placebo.||54.8|-287.7|0.817
72434538|NCT05419557|144382139|SUPERIORITY||Odds Ratio (OR)|8.5||||0.02|TWO_SIDED|95.0|1.3|54.6|||Regression, Logistic|||||54.6|1.3|0.02
72434539|NCT05419557|144382140|SUPERIORITY||Odds Ratio (OR)|9.98||||0.015|TWO_SIDED|95.0|1.55|64.25|||Regression, Logistic|||||64.25|1.55|0.015
72434540|NCT00920686|144382173|SUPERIORITY_OR_OTHER|||||||0.6407|||||||Log Rank|||||||0.6407
72434541|NCT04304534|144382190|OTHER|HRs were only calculated if at least three events occurred in one of the compared groups and at least one event in each of the compared treatment groups. The competing event was non-CV death for events that include CV death.|Cox Proportional Hazard|1.052|||=|0.8439|TWO_SIDED|90.0|0.687|1.612|||Log Rank|||Comparison of the Asundexian 20 mg group and 50 mg group versus Placebo group||1.612|0.687|= 0.8439
72434542|NCT04304534|144382190|OTHER|HRs were only calculated if at least three events occurred in one of the compared groups and at least one event in each of the compared treatment groups. The competing event was non-CV death for events that include CV death.|Cox Proportional Hazard|1.096|||=|0.7562|TWO_SIDED|90.0|0.674|1.781|||Log Rank|||Comparison of the Asundexian 20 mg group versus Placebo group||1.781|0.674|= 0.7562
72434543|NCT04304534|144382190|OTHER|HRs were only calculated if at least three events occurred in one of the compared groups and at least one event in each of the compared treatment groups. The competing event was non-CV death for events that include CV death.|Cox Proportional Hazard|1.008|||=|0.978|TWO_SIDED|90.0|0.614|1.656|||Log Rank|||Comparison of the Asundexian 50 mg group versus Placebo group||1.656|0.614|= 0.978
72434544|NCT04304534|144382191|OTHER|HR was only calculated if at least three events occurred in one of the compared groups and at least one event in each of the compared treatment groups.|Hazard Ratio (HR)|0.98|||=|0.9158|TWO_SIDED|90.0|0.713|1.347|||Log Rank|||Comparison of the Pooled Asundexian group versus Placebo group||1.347|0.713|= 0.9158
72434545|NCT04304534|144382191|OTHER|HR was only calculated if at least three events occurred in one of the compared groups and at least one event in each of the compared treatment groups.|Hazard Ratio (HR)|0.867|||=|0.5633|TWO_SIDED|90.0|0.577|1.302|||Log Rank|||Comparison of the Asundexian 10 mg group versus Placebo group||1.302|0.577|= 0.5633
72434546|NCT04304534|144382191|OTHER|HR was only calculated if at least three events occurred in one of the compared groups and at least one event in each of the compared treatment groups.|Hazard Ratio (HR)|0.875|||=|0.584|TWO_SIDED|90.0|0.587|1.306|||Log Rank|||Comparison of the Asundexian 20 mg group versus Placebo group||1.306|0.587|= 0.584
72434547|NCT04304534|144382191|OTHER|HR was only calculated if at least three events occurred in one of the compared groups and at least one event in each of the compared treatment groups.|Hazard Ratio (HR)|1.202|||=|0.417|TWO_SIDED|90.0|0.828|1.747|||Log Rank|||Comparison of the Asundexian 50 mg group versus Placebo group||1.747|0.828|= 0.417
72434548|NCT04304534|144382192|OTHER|HRs were only calculated if at least three events occurred in one of the compared groups and at least one event in each of the compared treatment groups. The competing event was non-CV death for events that include CV death.|Cox Proportional Hazard|1.275|||||TWO_SIDED|90.0|0.322|5.05||||||Comparison of the Asundexian 20 mg group and Asundexian 50 mg group versus Placebo group||5.050|0.322|
72434549|NCT04304534|144382192|OTHER|HRs were only calculated if at least three events occurred in one of the compared groups and at least one event in each of the compared treatment groups. The competing event was non-CV death for events that include CV death.|Cox Proportional Hazard|1.991|||||TWO_SIDED|90.0|0.479|8.273||||||Comparison of the Asundexian 50 mg group versus Placebo group||8.273|0.479|
72434550|NCT04304534|144382193|OTHER|HRs were only calculated if at least three events occurred in one of the compared groups and at least one event in each of the compared treatment groups. The competing event was non-CV death for events that include CV death.|Cox Proportional Hazard|1.125|||||TWO_SIDED|90.0|0.696|1.819||||||Comparison of the Asundexian 20 mg group and Asundexian 50 mg versus Placebo group||1.819|0.696|
72434551|NCT04304534|144382193|OTHER||Cox Proportional Hazard|1.181|||||TWO_SIDED|90.0|0.686|2.031||||||Comparison of the Asundexian 20 mg group versus Placebo group||2.031|0.686|
72618682|NCT01026038|144768108|SUPERIORITY_OR_OTHER||GMT ratio|1.0|||||TWO_SIDED|95.0|0.17|5.85||||||Serotype 6B: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||5.85|0.17|
72434552|NCT04304534|144382193|OTHER|HRs were only calculated if at least three events occurred in one of the compared groups and at least one event in each of the compared treatment groups. The competing event was non-CV death for events that include CV death.|Cox Proportional Hazard|1.07|||||TWO_SIDED|90.0|0.613|1.866||||||Comparison of the Asundexian 50 mg group versus Placebo group||1.866|0.613|
72434553|NCT04304534|144382196|OTHER|For all-cause mortality there is no competing event.|Cox Proportional Hazard|1.266|||=|0.6016|TWO_SIDED|90.0|0.603|2.658|||Log Rank|||Comparison of the Asundexian 20 mg group and Asundexian 50 mg group versus Placebo group||2.658|0.603|= 0.6016
72434554|NCT04304534|144382196|OTHER||Cox Proportional Hazard|0.996|||=|0.9945|TWO_SIDED|90.0|0.414|2.401|||Log Rank|||Comparison of the Asundexian 20 mg group versus Placebo group||2.401|0.414|= 0.9945
72434555|NCT04304534|144382196|OTHER||Cox Proportional Hazard|1.506|||=|0.4085|TWO_SIDED|90.0|0.667|3.405|||Log Rank|||Comparison of the Asundexian 50 mg group versus Placebo group||3.405|0.667|= 0.4085
72434556|NCT00300456|144382215|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||alpha = 0.05, all 3 primary endpoints had to show superiority of combo therapy in order to declare combo therapy successful at a given statin dose, Hochberg method for multiple comparison adjustment for 2 statin doses|ANCOVA|||An n = 92 per arm would provide \>99% power to detect a 24% decrease in triglycerides relative to statin monotherapy for each combo therapy dose, assuming an SD of 30%||||<0.001
72434557|NCT00300456|144382215|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||alpha = 0.05, all 3 primary endpoints had to show superiority of combo therapy in order to declare combo therapy successful at a given statin dose, Hochberg method for multiple comparison adjustment for 2 statin doses|ANCOVA|||An n = 92 per arm would provide \>99% power to detect 24% decrease in triglycerides relative to statin monotherapy for each combo therapy dose, assuming an SD of 30%||||<0.001
72434558|NCT00300456|144382216|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||alpha = 0.05, all 3 primary endpoints had to show superiority of combo therapy in order to declare combo therapy successful at a given statin dose, Hochberg method for multiple comparison adjustment for 2 statin doses|ANCOVA|||An n = 92 per arm would provide 98% power to detect a 9% increase in HDL-C relative to statin monotherapy for each combo therapy dose, assuming an SD of 15%||||<0.001
72434559|NCT00300456|144382216|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||alpha = 0.05, all 3 primary endpoints had to show superiority of combo therapy in order to declare combo therapy successful at a given statin dose, Hochberg method for multiple comparison adjustment for 2 statin doses|ANCOVA|||An n = 92 per arm would provide 98% power to detect a 9% increase in HDL-C relative to statin monotherapy for each combo therapy dose, assuming an SD of 15%||||<0.001
72434560|NCT00300456|144382217|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||alpha = 0.05, all 3 primary endpoints had to show superiority of combo therapy in order to declare combo therapy successful at a given statin dose, Hochberg method for multiple comparison adjustment for 2 statin doses|ANCOVA|||An n = 92 per arm would provide \>99% power to detect an 11% decrease in LDL-C relative to ABT-335 monotherapy for each combo therapy dose, assuming an SD of 15%||||<0.001
72434561|NCT00300456|144382217|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||alpha = 0.05, all 3 primary endpoints had to show superiority of combo therapy in order to declare combo therapy successful at a given statin dose, Hochberg method for multiple comparison adjustment for 2 statin doses|ANCOVA|||An n = 92 per arm would provide \>99% power to detect an 11% decrease in LDL-C relative to ABT-335 monotherapy for each combo therapy dose, assuming an SD of 15%||||<0.001
72434562|NCT00843193|144382264|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.11||||0.1955|TWO_SIDED|95.0|-0.27|0.06|||ANCOVA|||Comparison between GSK679586 10 mg/kg and Placebo at Week 2||0.06|-0.27|0.1955
72434563|NCT00843193|144382264|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.19||||0.0193|TWO_SIDED|95.0|-0.34|-0.03|||Mixed Model Repeated Measures analysis|||Comparison between GSK679586 10 mg/kg and Placebo at Week 4||-0.03|-0.34|0.0193
72382412|NCT00667602|144273598|NON_INFERIORITY_OR_EQUIVALENCE|(PConcomitant Vaccine + MenACWY - PConcomitant Vaccine+MenC).|Percentage difference|-5.0|||||TWO_SIDED|95.0|-12.0|1.0|||Miettinen and Nurminen|Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.||Immunogenicity of PCV7 (PNC 23F, one month postvaccination) given concomitantly with one dose of MenACWY was considered non-inferior to PCV7 given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%.||1|-12|
72382413|NCT00667602|144273598|NON_INFERIORITY_OR_EQUIVALENCE|(PConcomitant Vaccine + MenACWY - PConcomitant Vaccine+MenC).|Percentage difference|-5.0|||||TWO_SIDED|95.0|-12.0|4.0|||Miettinen and Nurminen|Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.||Immunogenicity of PCV7 (PNC4, one month postvaccination) given concomitantly with two doses of MenACWY was considered non-inferior to PCV7 given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%.||4|-12|
72382414|NCT00667602|144273598|NON_INFERIORITY_OR_EQUIVALENCE|(PConcomitant Vaccine + MenACWY - PConcomitant Vaccine+MenC).|Percentage difference|-5.0|||||TWO_SIDED|95.0|-11.0|0.0|||Miettinen and Nurminen|Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.||Immunogenicity of PCV7 (PNC6B, one month postvaccination) given concomitantly with two doses of MenACWY was considered non-inferior to PCV7 given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%.||0|-11|
72382415|NCT00667602|144273598|NON_INFERIORITY_OR_EQUIVALENCE|(PConcomitant Vaccine + MenACWY - PConcomitant Vaccine+MenC).|Percentage difference|-3.0|||||TWO_SIDED|95.0|-10.0|3.0|||Miettinen and Nurminen|Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.||Immunogenicity of PCV7 (PNC 9V, one month postvaccination) given concomitantly with two doses of MenACWY was considered non-inferior to PCV7 given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%.||3|-10|
72382416|NCT00667602|144273598|NON_INFERIORITY_OR_EQUIVALENCE|(PConcomitant Vaccine + MenACWY - PConcomitant Vaccine+MenC).|Percentage difference|-1.0|||||TWO_SIDED|95.0|-4.0|3.0|||Miettinen and Nurminen|Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.||Immunogenicity of PCV7 (PNC14, one month postvaccination) given concomitantly with two doses of MenACWY was considered non-inferior to PCV7 given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%.||3|-4|
72382417|NCT00667602|144273598|NON_INFERIORITY_OR_EQUIVALENCE|(PConcomitant Vaccine + MenACWY - PConcomitant Vaccine+MenC).|Percentage difference|-15.0|||||TWO_SIDED|95.0|-24.0|-6.0|||Miettinen and Nurminen|Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.||Immunogenicity of PCV7 (PNC18C, one month postvaccination) given concomitantly with two doses of MenACWY was considered non-inferior to PCV7 given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%.||-6|-24|
72557425|NCT00205777|144645420|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.645||||0.15|TWO_SIDED|95.0|0.361|1.151|||Log Rank|||No Prevalent Fractures: P value was calculated using stratified log-rank test. Hazard ratio (Bazedoxifene 40/20 mg \[SE I\] versus Placebo \[Core+SE I+SE II\]) based on a Cox proportional hazards regression model was presented along with 95% CIs.||1.151|0.361|0.15
72382418|NCT00667602|144273598|NON_INFERIORITY_OR_EQUIVALENCE|(PConcomitant Vaccine + MenACWY - PConcomitant Vaccine+MenC).|Percentage difference|-9.0|||||TWO_SIDED|95.0|-17.0|-1.0|||Miettinen and Nurminen|Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.||Immunogenicity of PCV7 (PNC19F, one month postvaccination) given concomitantly with two doses of MenACWY was considered non-inferior to PCV7 given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%.||-1|-17|
72382419|NCT00667602|144273598|NON_INFERIORITY_OR_EQUIVALENCE|(PConcomitant Vaccine + MenACWY - PConcomitant Vaccine+MenC).|Percentage difference|-6.0|||||TWO_SIDED|95.0|-13.0|0.0|||Miettinen and Nurminen|Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.||Immunogenicity of PCV7 (PNC23F, one month postvaccination) given concomitantly with two doses of MenACWY was considered non-inferior to PCV7 given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%.||0|-13|
72434564|NCT00843193|144382264|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.05||||0.6156|TWO_SIDED|95.0|-0.23|0.14|||Mixed Model Repeated Measures analysis|||Comparison between GSK679586 10 mg/kg and Placebo at Week 8||0.14|-0.23|0.6156
72434565|NCT00843193|144382264|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.08||||0.4672|TWO_SIDED|95.0|-0.31|0.14|||ANCOVA|||Comparison between GSK679586 120 mg/kg and Placebo at Week 12||0.14|-0.31|0.4672
72434566|NCT00843193|144382267|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01||||0.7693|TWO_SIDED|95.0|-0.08|0.06|||ANCOVA|||Comparison between GSK679586 10 mg/kg and Placebo at Week 2||0.06|-0.08|0.7693
72434567|NCT00843193|144382267|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01||||0.8987|TWO_SIDED|95.0|-0.08|0.09|||Mixed Model Repeated Measures analysis|||Comparison between GSK679586 10 mg/kg and Placebo at Week 4||0.09|-0.08|0.8987
72434568|NCT00843193|144382267|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.04||||0.4231|TWO_SIDED|95.0|-0.12|0.05|||Mixed Model Repeated Measures analysis|||Comparison between GSK679586 10 mg/kg and Placebo at Week 8||0.05|-0.12|0.4231
72434569|NCT00843193|144382267|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.0537|TWO_SIDED|95.0|-0.19|0.0|||Mixed Model Repeated Measures analysis|||Comparison between GSK679586 10 mg/kg and Placebo at Week 12||0.00|-0.19|0.0537
72434570|NCT04511650|144382286|SUPERIORITY|||||||0.4795|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by disease severity.||Pooled Razuprotafib comparison to Placebo. All results are summarized descriptively by treatment arm and expressed as proportions, along with corresponding 95% confidence intervals (CIs) of the difference between response rates, and p-values.||||0.4795
72434571|NCT02982213|144382297|SUPERIORITY||Mean Difference (Net)|0.025||||0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.001
72434572|NCT02982213|144382301|EQUIVALENCE|Sample size of 5 per group to achieve 80% power to detect a change in the log odds ration of 1.0 at a .05 significance level using a two sided Mann Whitney U test.||||||0.001|TWO_SIDED|95.0|||||McNemar|||||||.001
72434573|NCT01972152|144382303|SUPERIORITY_OR_OTHER|||||||0.24|TWO_SIDED||||||Mixed Models Analysis|Data were log transformed for analysis.||||||0.24
72434574|NCT01972152|144382304|SUPERIORITY_OR_OTHER|||||||0.34|TWO_SIDED|||||Data were log transformed for analysis.|Mixed Models Analysis|||||||0.34
72434575|NCT01972152|144382304|SUPERIORITY_OR_OTHER|||||||0.01|TWO_SIDED|||||Data were log transformed for analysis.|Mixed Models Analysis|||||||0.01
72434576|NCT01972152|144382305|SUPERIORITY_OR_OTHER|||||||0.95|TWO_SIDED||||||Mixed Models Analysis|||||||0.95
72434577|NCT01972152|144382306|SUPERIORITY_OR_OTHER|||||||0.76|TWO_SIDED||||||Mixed Models Analysis|||||||0.76
72434578|NCT01972152|144382307|SUPERIORITY_OR_OTHER|||||||0.68|TWO_SIDED||||||Mixed Models Analysis|||||||0.68
72434579|NCT01972152|144382307|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED||||||Mixed Models Analysis|||||||0.02
72434580|NCT01972152|144382308|SUPERIORITY_OR_OTHER|||||||0.16|TWO_SIDED||||||Mixed Models Analysis|Data were log transformed for analysis||||||0.16
72494086|NCT01390909|144517164|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|150.0|||<|0.0001|TWO_SIDED|95.0|112.0|199.0||Adjusted Cost Differences in Epilepsy-Related Emergency Department Visits|Ordinary Least Squares Regression|Ordinary least squares regression was used to adjust differences. Covariates were gender, age, region, comorbidities, baseline treatment, and costs.|Confidence intervals were calculated using a nonparametric bootstrap with 999 replications.|||199|112|<0.0001
72494087|NCT01390909|144517164|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|516.0|||<|0.0001|TWO_SIDED|95.0|401.0|645.0||Adjusted Cost Differences in Epilepsy-Related Outpatient Services|Ordinary Least Squares Regression|Ordinary least squares regression was used to adjust differences. Covariates were gender, age, region, comorbidities, baseline treatment, and costs.|Confidence intervals were calculated using a nonparametric bootstrap with 999 replications.|||645|401|<0.0001
72494088|NCT01390909|144517164|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|158.0|||<|0.0001|TWO_SIDED|95.0|97.0|231.0||Adjusted Cost Differences in Epilepsy-Related Neurologist Visits|Ordinary Least Squares Regression|Ordinary least squares regression was used to adjust differences. Covariates were gender, age, region, comorbidities, baseline treatment, and costs.|Confidence intervals were calculated using a nonparametric bootstrap with 999 replications.|||231|97|<0.0001
72434581|NCT01972152|144382309|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|Data were log transformed for analysis||||||<0.001
72434582|NCT01972152|144382309|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|Data were log transformed for analysis||||||<0.001
72434583|NCT01972152|144382310|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|Data were log transformed for analysis||||||<0.001
72434584|NCT01972152|144382310|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Data were log transformed for analysis.|Mixed Models Analysis|||||||<0.001
72434585|NCT01972152|144382311|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
72434586|NCT01972152|144382311|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
72434587|NCT01194258|144382314|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin was set at 0.40.|LS Mean difference|-0.04|STANDARD_ERROR_OF_MEAN|0.041||0.3876|TWO_SIDED|95.0|-0.12|0.05|||Mixed Models Analysis|||Approximately 110 participants were planned to be enrolled to allow approximately 88 participants to complete both treatment periods. Assuming a dropout rate of ≤20%, an intra-participant correlation of 0.80, a standard deviation of 1.2, and a true difference of 0, the study would have \>90% power to show that either Lispro-PH20 or Aspart-PH20 (each tested separately) was non-inferior to insulin lispro alone with respect to the change from baseline in A1C at the end of each treatment period.||0.05|-0.12|0.3876
72434588|NCT01656304|144382333|SUPERIORITY_OR_OTHER||Rate|0.333|STANDARD_ERROR_OF_MEAN|0.1217|||TWO_SIDED|80.0|0.2|0.5||||||||.50|.20|
72434589|NCT05826431|144382340|OTHER||Mean Difference (Final Values)|18.65||||0.153|TWO_SIDED||||||Paired samples t-test|||Study analyses were conducted using IBM SPSS Statistics Version 29. Frequencies and descriptive data were tabulated to describe the sample and quantify device use, satisfaction, and perceived impact. Qualitative responses regarding usability and feasibility were summarized based on the themes of the responses.||||0.153
72434590|NCT05826431|144382341|OTHER||Mean Difference (Final Values)|0.61||||0.103|TWO_SIDED||||||Paired samples t-test|||||||0.103
72434591|NCT05826431|144382343|OTHER|Single group, frequencies, and descriptive data|Mean Difference (Final Values)|4.22||||0.083|TWO_SIDED||||||Paired samples t-test|||||||.083
72434592|NCT05826431|144382344|OTHER||Mean Difference (Final Values)|-0.26||||441|TWO_SIDED||||||Paired samples t-test|||||||0441
72434593|NCT05826431|144382345|OTHER||Mean Difference (Final Values)|2.61||||0.095|TWO_SIDED||||||Paired samples t-test|||||||0.095
72434594|NCT05826431|144382346|OTHER||Mean Difference (Final Values)|0.03||||0.487|TWO_SIDED||||||Paired samples t-test|||||||0.487
72434595|NCT05826431|144382347|OTHER||Mean Difference (Final Values)|-0.06||||0.483|TWO_SIDED||||||Paired samples t-test|||||||0.483
72434596|NCT05826431|144382348|OTHER||Mean Difference (Final Values)|-2.82||||0.0483|TWO_SIDED||||||Paired samples t-test|||||||.0483
72434597|NCT05826431|144382349|OTHER||Mean Difference (Final Values)|-0.42||||0.123|TWO_SIDED||||||Paired samples t-test|||||||0.123
72434598|NCT04520165|144382382|EQUIVALENCE|if p\<0.05 than the null hypothesis was considered as wrong and groups differed for the analysed parameter.|||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||The baseline parameters in each group were compared with Mann-Whitney U test was performed.||||<0.05
72434599|NCT04520165|144382384|EQUIVALENCE|if p\<0.05 than the null hypothesis was considered as wrong and groups differed for the analysed parameter.|||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||The baseline parameters in each group were compared with Mann-Whitney U test was performed.||||<0.05
72434600|NCT04520165|144382385|EQUIVALENCE|if p\<0.05 than the null hypothesis was considered as wrong and groups differed for the analysed parameter.|||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||The baseline parameters in each group were compared with Mann-Whitney U test was performed.||||<0.05
72434601|NCT00798265|144382436|OTHER|||||||0.002||||||The reported p-value is representative of the changes in HPV-16 at 7 months in Cohort 1.|Spearman correlation (non-parametric)|||||||0.0020
72434602|NCT00798265|144382436|OTHER||||||<|0.0001||||||The reported p-value is representative of the changes in HPV-18 at 7 months in Cohort 1.|Spearman correlation (non-parametric)|||||||<.0001
72434603|NCT00798265|144382436|OTHER|||||||0.0002||||||The reported p-value is representative of the changes in HPV-16 at 7 months in Cohort 2.|Spearman correlation (non-parametric)|||||||0.0002
72434604|NCT00798265|144382436|OTHER||||||<|0.0001||||||The reported p-value is representative of the changes in HPV-18 at 7 months in Cohort 2.|Spearman correlation (non-parametric)|||||||<.0001
72434605|NCT02085356|144382484|OTHER||Odds Ratio (OR)|1.12|||||TWO_SIDED|||||||||||||
72434606|NCT02085356|144382485|OTHER||Odds Ratio (OR)|0.32|||||TWO_SIDED|||||||||||||
72434607|NCT02085356|144382486|OTHER|||||||0.605|||||||Mixed Models Analysis|||||||0.605
72434608|NCT02085356|144382487|OTHER|||||||0.902|||||||Chi-squared|||Attendance records could not be retrieved for most participants. However, this analysis was still conducted among those participants who had data.||||0.902
72434609|NCT02085356|144382488|OTHER|||||||0.869|||||||Mixed Models Analysis|||||||0.869
72434610|NCT02085356|144382488|OTHER||Odds Ratio (OR)|0.32||||0.982|TWO_SIDED||||||Mixed Models Analysis|||||||0.982
72434611|NCT00739102|144382489|SUPERIORITY_OR_OTHER||Proportion - 12-month patency rate|0.665|STANDARD_ERROR_OF_MEAN|0.032||0.437|TWO_SIDED|95.0|0.6|0.725||The observed rate of primary patency at 12 month was 66.5% (143/215) with a lower 95% confidence interval of 60.0%.|Agresti-Coull method||The 95% confidence intervals and the standard error were calculated using the Agresti-Coull method|The null hypothesis to be tested was Ho: P = 0.66 against Ha: P \> 0.66, where 0.66 was the Objective Performance Criteria (OPC). A sample size of 212 subjects was required to achieve 90% power to reject the 66% 12-months patency rate at a one-sided 2.5% significance level when the unknown true patency is at 76%.||0.725|0.6|0.437
72557426|NCT00205777|144645420|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.941||||0.83|TWO_SIDED|95.0|0.493|1.793|||Log Rank|||No Prevalent Fractures: P value was calculated using stratified log-rank test. Hazard ratio (Bazedoxifene 20 mg \[Core+SE I\] versus Bazedoxifene 40/20 mg \[SE I\]) based on a Cox proportional hazards regression model was presented along with 95% CIs.||1.793|0.493|0.83
72434612|NCT00739102|144382491|SUPERIORITY_OR_OTHER||Death Rate (%)|2.1|||||TWO_SIDED|95.0|0.7|4.9||||||||4.9|0.7|
72557427|NCT00205777|144645420|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.666||||0.067|TWO_SIDED|95.0|0.435|1.019|||Log Rank|||At Least 1 Prevalent Fracture: P value was calculated using stratified log-rank test. Hazard ratio (Bazedoxifene 20 mg \[Core+SE I\] versus Placebo \[Core+SE I+SE II\]) based on a Cox proportional hazards regression model was presented along with 95% CIs.||1.019|0.435|0.067
72434613|NCT00739102|144382492|SUPERIORITY_OR_OTHER||Index Limb Amputation Rate (%)|0.0|||||TWO_SIDED|95.0|0.0|1.5||||||||1.5|0.0|
72434614|NCT00739102|144382493|SUPERIORITY_OR_OTHER||Clinically Driven TVR Rate (%)|0.0|||||TWO_SIDED|95.0|0.0|1.5||||||||1.5|0.0|
72434615|NCT00739102|144382494|SUPERIORITY_OR_OTHER||Clinically Driven TVR Rate (%)|13.6|||||TWO_SIDED|95.0|9.5|18.6||||||||18.6|9.5|
72434616|NCT00739102|144382495|SUPERIORITY_OR_OTHER||Stent Fracture Rate (%)|1.5|||||TWO_SIDED|95.0|0.3|4.4||||||||4.4|0.3|
72434617|NCT00739102|144382496|SUPERIORITY_OR_OTHER||Index Limb Ischemia Rate (%)|5.6||||||95.0||||||||||||
72434618|NCT00739102|144382497|SUPERIORITY_OR_OTHER||Primary safety endpoint rate (%)|100.0|||<|0.001|TWO_SIDED|95.0|98.2|100.0|||Agresti-Coull method|||The null hypothesis to be tested was Ho: P = 0.88 against Ha: P \> 0.88, where 0.88 was the Objective Performance Criteria (OPC).||100|98.2|<0.001
72434619|NCT00739102|144382498|SUPERIORITY_OR_OTHER||Index Limb Ischemia Rate (%)|8.4||||||95.0||||||||||||
72434620|NCT00739102|144382501|SUPERIORITY_OR_OTHER||Major adverse event rate (%)|14.4|||||TWO_SIDED|95.0|10.2|19.5||||||||19.5|10.2|
72434621|NCT02657629|144382529|SUPERIORITY_OR_OTHER|||||||0.05|TWO_SIDED||||||t-test, 2 sided|||||||0.05
72557428|NCT00205777|144645420|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.573||||0.014|TWO_SIDED|95.0|0.367|0.896|||Log Rank|||At Least 1 Prevalent Fracture: P value was calculated using stratified log-rank test. Hazard ratio (Bazedoxifene 40/20 mg \[SE I\] versus Placebo \[Core+SE I+SE II\]) based on a Cox proportional hazards regression model was presented along with 95% CIs.||0.896|0.367|0.014
72618683|NCT01026038|144768108|SUPERIORITY_OR_OTHER||GMT ratio|0.7|||||TWO_SIDED|95.0|0.15|3.72||||||Serotype 6B: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||3.72|0.15|
72434622|NCT02987543|144382530|SUPERIORITY||Odds Ratio (OR)|20.86|||<|0.0001|TWO_SIDED|95.0|4.18|379.18|||Regression, Logistic|||||379.18|4.18|<0.0001
72434623|NCT02987543|144382531|SUPERIORITY||Hazard Ratio (HR)|0.49|||<|0.0001|TWO_SIDED|95.0|0.38|0.63|||Regression, Cox|||||0.63|0.38|<0.0001
72434624|NCT02987543|144382532|SUPERIORITY||Hazard Ratio (HR)|0.44||||0.0192|TWO_SIDED|95.0|0.22|0.91|||Regression, Cox|||||0.91|0.22|0.0192
72434625|NCT02987543|144382533|SUPERIORITY||Hazard Ratio (HR)|0.69||||0.0175|TWO_SIDED|95.0|0.5|0.97||2-sided p-value|Regression, Cox|||||0.97|0.50|0.0175
72434626|NCT02987543|144382534|SUPERIORITY||Hazard Ratio (HR)|0.34|||<|0.0001|TWO_SIDED|95.0|0.25|0.47|||Regression, Cox|||||0.47|0.25|<0.0001
72434627|NCT01280591|144382542|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-70.3|STANDARD_ERROR_OF_MEAN|13.17||0.0002|TWO_SIDED|95.0|-106.8|-33.7|||ANCOVA|||||-33.7|-106.8|0.0002
72434628|NCT01280591|144382543|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Log Rank|||||||<0.0001
72434629|NCT01280591|144382544|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|70.4|STANDARD_ERROR_OF_MEAN|12.85||0.0001|TWO_SIDED|95.0|28.1|112.7|||ANCOVA|||||112.7|28.1|0.0001
72434630|NCT01280591|144382545|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.7|STANDARD_ERROR_OF_MEAN|2.14||0.0007|TWO_SIDED|95.0|3.7|19.7|||ANCOVA|||||19.7|3.7|0.0007
72434631|NCT01280591|144382546|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
72434632|NCT01280591|144382547|SUPERIORITY_OR_OTHER|||||||0.0027|||||||Cochran-Mantel-Haenszel|||||||0.0027
72434633|NCT01280591|144382548|SUPERIORITY_OR_OTHER|||||||0.0321|||||||Cochran-Mantel-Haenszel|||||||0.0321
72434634|NCT01280591|144382549|SUPERIORITY_OR_OTHER|||||||0.0019|||||||Cochran-Mantel-Haenszel|||||||0.0019
72434635|NCT01280591|144382550|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
72434636|NCT01280591|144382551|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Cochran-Mantel-Haenszel|||||||>0.05
72434637|NCT01280591|144382552|SUPERIORITY_OR_OTHER|||||||0.0012|||||||Cochran-Mantel-Haenszel|||||||0.0012
72434638|NCT01280591|144382553|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
72434639|NCT01280591|144382554|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
72434640|NCT01280591|144382555|SUPERIORITY_OR_OTHER|||||||0.0016|||||||Cochran-Mantel-Haenszel|||||||0.0016
72434641|NCT01280591|144382556|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Cochran-Mantel-Haenszel|||||||>0.05
72434642|NCT01280591|144382557|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
72434643|NCT01280591|144382558|SUPERIORITY_OR_OTHER|||||||0.0064|||||||ANCOVA|||||||0.0064
72434644|NCT01280591|144382559|SUPERIORITY_OR_OTHER|||||||0.0047|||||||Cochran-Mantel-Haenszel|||||||0.0047
72382420|NCT00667602|144273603|NON_INFERIORITY_OR_EQUIVALENCE|(PConcomitant Vaccine + MenACWY-CRM - PConcomitant Vaccine + MenC).|Percentage difference|71.0|||||TWO_SIDED|95.0|63.0|78.0|||Miettinen and Nurminen|Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.||For the comparisons to MenC based on percentages of subjects with response (rSBA ≥1:8, prevaccination), MenACWY-CRM197 was determined to be non-inferior to MenC if the lower limit of the two-sided 95% CI for the difference between MenACWY-CRM197 and MenC in the percentage of subjects with response against serogroup C was greater than -10%.||78|63|
72382421|NCT00667602|144273603|NON_INFERIORITY_OR_EQUIVALENCE|(PConcomitant Vaccine + MenACWY-CRM - PConcomitant Vaccine + MenC).|Percentage difference|2.0|||||TWO_SIDED|95.0|-3.0|6.0|||Miettinen and Nurminen|Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.||For the comparisons to MenC based on percentages of subjects with response (rSBA ≥1:8, one month postvaccination), MenACWY-CRM197 was determined to be non-inferior to MenC if the lower limit of the two-sided 95% CI for the difference between MenACWY-CRM197 and MenC in the percentage of subjects with response against serogroup C was greater than -10%.||6|-3|
72434645|NCT01280591|144382560|SUPERIORITY_OR_OTHER|||||||0.0053|||||||Log Rank|||||||0.0053
72434646|NCT01280591|144382562|SUPERIORITY_OR_OTHER|||||||0.2734|||||||Cochran-Mantel-Haenszel|||||||0.2734
72434647|NCT01466881|144382629|SUPERIORITY_OR_OTHER|||||||0.2316|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|Two-sided alpha level of 0.05||The null hypothesis is that there is no significant difference in Aurora kinase A expression between responders and non-responders.||||0.2316
72434648|NCT01444287|144382638|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.636|STANDARD_ERROR_OF_MEAN|0.2093||0.0035||95.0|||||Mixed Models Analysis||The mean difference is calculated as: Control-Test.|Ho: No Lenses (control) - narafilcon B (test) = 0. Ha: No Lenses (control) - narafilcon B (test) ≠ 0.||||0.0035
72434649|NCT01444287|144382638|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.743|STANDARD_ERROR_OF_MEAN|0.2093||0||95.0|||||Mixed Models Analysis||The mean difference is calculated as: Control - Test.|Ho: Polymacon (+ control) - Narafilcon B (test) = 0. Ha: Polymacon (+ control) - Narafilcon B (test) ≠ 0.||||0.0000
72434650|NCT01444287|144382638|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.0275|STANDARD_ERROR_OF_MEAN|0.2093||0.8957||95.0|||||Mixed Models Analysis||The mean difference is calculated as: Control-Test.|Ho: lotrafilcon A (control) - narafilcon B (test) = 0. Ha: lotrafilcon A (control) - narafilcon B (test) ≠ 0.||||0.8957
72434651|NCT01444287|144382639|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.0057|STANDARD_ERROR_OF_MEAN|0.0031||0.0692||95.0|||||Mixed Models Analysis||The mean difference is calculated as: Control-Test.|Ho: No Lenses (control) - narafilcon B (test) = 0. Ha: No Lenses (control) - narafilcon B (test) ≠ 0.||||0.0692
72434652|NCT01444287|144382639|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.0011|STANDARD_ERROR_OF_MEAN|0.0032||0.7301||95.0|||||Mixed Models Analysis||The mean difference is calculated as: Control-Test.|Ho: Polymacon (+ control) - Narafilcon B (test) = 0. Ha: Polymacon (+ control) - Narafilcon B (test) ≠ 0.||||0.7301
72434653|NCT01444287|144382639|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.0008|STANDARD_ERROR_OF_MEAN|0.0032||0.8055||95.0|||||Mixed Models Analysis||The mean difference is calculated as: Control-Test.|Ho: lotrafilcon A (control) - narafilcon B (test) = 0. Ha: lotrafilcon A (control) - narafilcon B (test) ≠ 0.||||0.8055
72434654|NCT01444287|144382640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0122|STANDARD_ERROR_OF_MEAN|0.1111||0.9127||95.0|||||Mixed Models Analysis||The mean difference is calculated as: Control-Test.|Ho: No Lenses (control) - narafilcon B (test) = 0. Ha: No Lenses (control) - narafilcon B (test) ≠ 0.||||0.9127
72434655|NCT01444287|144382640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.6864|STANDARD_ERROR_OF_MEAN|0.1098||0||95.0|||||Mixed Models Analysis||The mean difference is calculated as: Control-Test.|Ho: Polymacon (+ control) - Narafilcon B (test) = 0. Ha: Polymacon (+ control) - Narafilcon B (test) ≠ 0.||||0.0000
72434656|NCT01444287|144382640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1705|STANDARD_ERROR_OF_MEAN|0.1098||0.1256||95.0|||||Mixed Models Analysis||The mean difference is calculated as: Control-Test.|Ho: lotrafilcon A (control) - narafilcon B (test) = 0. Ha: lotrafilcon A (control) - narafilcon B (test) ≠ 0.||||0.1256
72434657|NCT01444287|144382641|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.0688|STANDARD_ERROR_OF_MEAN|5.044||0.9892||95.0|||||Mixed Models Analysis||The mean difference is calculated as: Control-Test.|Ho: No Lenses (control) - narafilcon B (test) = 0. Ha: No Lenses (control) - narafilcon B (test) ≠ 0.||||0.9892
72434658|NCT01444287|144382641|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.75|STANDARD_ERROR_OF_MEAN|4.984||0.0007||95.0|||||Mixed Models Analysis||The mean difference is calculated as: Control-Test.|Ho: Polymacon (+ control) - Narafilcon B (test) = 0. Ha: Polymacon (+ control) - Narafilcon B (test) ≠ 0.||||0.0007
72434659|NCT01444287|144382641|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.37|STANDARD_ERROR_OF_MEAN|4.984||0.003||95.0|||||Mixed Models Analysis||The mean difference is calculated as: Control-Test.|Ho: lotrafilcon A (control) - narafilcon B (test) = 0. Ha: lotrafilcon A (control) - narafilcon B (test) ≠ 0.||||0.0030
72434660|NCT01970943|144382687|OTHER||Mean Difference (Final Values)|0.6078||||0.05|TWO_SIDED||||||t-test, 2 sided|||||||0.05
72434661|NCT01970943|144382689|OTHER||Mean Difference (Final Values)|0.037786||||0.05|TWO_SIDED||||||t-test, 2 sided|||||||.05
72434662|NCT02469064|144382701|OTHER||Hazard Ratio (HR)|0.82||||0.84|TWO_SIDED|95.0|0.55|1.2|||Mann Whitneey||Univariate analysis of the probability of extubation was performed using Kaplan-Meir survival analysis and the logrank test.The multivariate analysis was performed by cox regression, a simple model was performed and a final model.|||1.20|0.55|0.84
72382422|NCT00667602|144273603|NON_INFERIORITY_OR_EQUIVALENCE|(PConcomitant Vaccine + MenACWY-CRM - PConcomitant Vaccine + MenC).|Percentage difference|2.0|||||TWO_SIDED|95.0|-2.0|7.0|||Miettinen and Nurminen|Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.||For the comparisons to MenC based on percentages of subjects with response (rSBA ≥1:8, prevaccination), MenACWY-CRM197 was determined to be non-inferior to MenC if the lower limit of the two-sided 95% CI for the difference between MenACWY-CRM197 and MenC in the percentage of subjects with response against serogroup C was greater than -10%.||7|-2|
72382423|NCT00667602|144273603|NON_INFERIORITY_OR_EQUIVALENCE|(PConcomitant Vaccine + MenACWY-CRM - PConcomitant Vaccine + MenC).|Percentage difference|-5.0|||||TWO_SIDED|95.0|-11.0|1.0|||Miettinen and Nurminen|Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.||For the comparisons to MenC based on percentages of subjects with response (rSBA ≥1:8, one month postvaccination), MenACWY-CRM197 was determined to be non-inferior to MenC if the lower limit of the two-sided 95% CI for the difference between MenACWY-CRM197 and MenC in the percentage of subjects with response against serogroup C was greater than -10%.||1|-11|
72382424|NCT00667602|144273603|NON_INFERIORITY_OR_EQUIVALENCE|(PConcomitant Vaccine + MenACWY-CRM - PConcomitant Vaccine + MenC).|Percentage difference|31.0|||||TWO_SIDED|95.0|24.0|39.0|||Miettinen and Nurminen|Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.||For the comparisons to MenC based on percentages of subjects with response (rSBA ≥1:128, prevaccination), MenACWY-CRM197 was determined to be non-inferior to MenC if the lower limit of the two-sided 95% CI for the difference between MenACWY-CRM197 and MenC in the percentage of subjects with response against serogroup C was greater than -10%.||39|24|
72382425|NCT00667602|144273603|NON_INFERIORITY_OR_EQUIVALENCE|(PConcomitant Vaccine + MenACWY-CRM - PConcomitant Vaccine + MenC).|Percentage difference|1.0|||||TWO_SIDED|95.0|-2.0|4.0|||Miettinen and Nurminen|Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.||For the comparisons to MenC based on percentages of subjects with response (rSBA ≥1:128, one month postvaccination), MenACWY-CRM197 was determined to be non-inferior to MenC if the lower limit of the two-sided 95% CI for the difference between MenACWY-CRM197 and MenC in the percentage of subjects with response against serogroup C was greater than -10%.||4|-2|
72382426|NCT00667602|144273603|NON_INFERIORITY_OR_EQUIVALENCE|PConcomitant Vaccine + MenACWY-CRM - PConcomitant Vaccine + MenC).|Percentage Difference|4.0|||||TWO_SIDED|95.0|-3.0|11.0|||Miettinen and Nurminen|Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.||For the comparisons to MenC based on percentages of subjects with response (rSBA ≥1:128, prevaccination), MenACWY-CRM197 was determined to be non-inferior to MenC if the lower limit of the two-sided 95% CI for the difference between MenACWY-CRM197 and MenC in the percentage of subjects with response against serogroup C was greater than -10%.||11|-3|
72382427|NCT00667602|144273603|NON_INFERIORITY_OR_EQUIVALENCE|PConcomitant Vaccine + MenACWY-CRM - PConcomitant Vaccine + MenC).|Percentage Difference|-13.0|||||TWO_SIDED|95.0|-22.0|-5.0|||Miettinen and Nurminen|Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.||For the comparisons to MenC based on percentages of subjects with response (rSBA ≥1:128, one month postvaccination), MenACWY-CRM197 was determined to be non-inferior to MenC if the lower limit of the two-sided 95% CI for the difference between MenACWY-CRM197 and MenC in the percentage of subjects with response against serogroup C was greater than -10%.||-5|-22|
72382428|NCT00667602|144273603|NON_INFERIORITY_OR_EQUIVALENCE|PConcomitant Vaccine + MenACWY-CRM - PConcomitant Vaccine + MenC).|Percentage Difference|-10.0|||||TWO_SIDED|95.0|-17.0|-4.0|||Miettinen and Nurminen|Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.||For the comparisons to MenC based on percentages of subjects with response (four-fold rise in titers), MenACWY-CRM197 was determined to be non-inferior to MenC if the lower limit of the two-sided 95% CI for the difference between MenACWY-CRM197 and MenC in the percentage of subjects with response against serogroup C was greater than -10%.||-4|-17|
72382429|NCT00667602|144273603|NON_INFERIORITY_OR_EQUIVALENCE|PConcomitant Vaccine + MenACWY-CRM - PConcomitant Vaccine + MenC).|Percentage Difference|-5.0|||||TWO_SIDED|95.0|-11.0|1.0|||Miettinen and Nurminen|Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.||For the comparisons to MenC based on percentages of subjects with response (four-fold rise in titers), MenACWY-CRM197 was determined to be non-inferior to MenC if the lower limit of the two-sided 95% CI for the difference between MenACWY-CRM197 and MenC in the percentage of subjects with response against serogroup C was greater than -10%.||1|-11|
72382430|NCT00667602|144273605|NON_INFERIORITY_OR_EQUIVALENCE|(PConcomitant Vaccine + MenACWY-CRM - PConcomitant Vaccine + MenC)|Ratio|1.33|||||TWO_SIDED|95.0|0.96|1.83|||ANOVA|||For comparison of the Geometric Mean Titers at one month postvaccination at 12 months of age, MenACWY-CRM197 was determined to be non-inferior to MenC if the lower limit of the 2-sided 95% CI for the ratio of the MenACWY-CRM197 to MenC Geometric Mean Titers for serogroup C was greater than 0.5.||1.83|0.96|
72382431|NCT00973349|144273620|NON_INFERIORITY_OR_EQUIVALENCE|The 2-sided CIs were examined against a non-inferiority margin of 0.67|Geometric mean ratio at day 43|1.265|||||TWO_SIDED|95.0|0.998|1.603|||||Pairwise Comparisons of GMTs (95% CI) Between Vaccination Groups at Day 43, on the pooled age groups.|Two-sided 95% CI around the point estimates were to be presented for each endpoint.||1.603|0.998|
72434663|NCT02469064|144382702|OTHER||Slope|0.46||||0.48|TWO_SIDED|95.0|-3.75|4.78|||t-test, 2 sided||The slope shows the difference between the means of the change in the MIP of the group that received the experimental treatment and the group that received the conventional treatment|||4.78|-3.75|0.48
72434664|NCT02155829|144382703|SUPERIORITY|||||||0.442|||||||ANCOVA|ANCOVA covariate included site.||||||0.442
72434665|NCT02155829|144382704|SUPERIORITY|||||||0.994|||||||ANCOVA|ANCOVA covariate included site.||||||0.994
72434666|NCT02155829|144382705|SUPERIORITY|||||||0.684|||||||ANCOVA|ANCOVA covariate included site.||||||0.684
72618684|NCT01026038|144768108|SUPERIORITY_OR_OTHER||GMT ratio|0.7|||||TWO_SIDED|95.0|0.1|5.37||||||Serotype 6B: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||5.37|0.10|
72434667|NCT02155829|144382706|SUPERIORITY|||||||0.913|||||||ANCOVA|ANCOVA covariate included site.||||||0.913
72434668|NCT02155829|144382707|SUPERIORITY|||||||0.746|||||||ANCOVA|ANCOVA covariate included site.||||||0.746
72434669|NCT02155829|144382708|SUPERIORITY|||||||0.057|||||||ANCOVA|ANCOVA covariate included site.||||||0.057
72382432|NCT00973349|144273620|NON_INFERIORITY_OR_EQUIVALENCE|The 2-sided CIs were examined against a non-inferiority margin of 0.67|Geometric mean ratio at day 43|0.999|||||TWO_SIDED|95.0|0.791|1.262|||||Pairwise Comparisons of GMTs (95% CI) Between Vaccination Groups at Day 43, on the pooled age groups.|Two-sided 95% CI around the point estimates were to be presented for each endpoint.||1.262|0.791|
72382433|NCT00973349|144273620|NON_INFERIORITY_OR_EQUIVALENCE|The 2-sided CIs were examined against a non-inferiority margin of 0.67|Geometric mean ratio at day 43|0.708|||||TWO_SIDED|95.0|0.558|0.897|||||Pairwise Comparisons of GMTs (95% CI) Between Vaccination Groups at Day 43, on the pooled age groups.|Two-sided 95% CI around the point estimates were to be presented for each endpoint.||0.897|0.558|
72382434|NCT00973349|144273620|NON_INFERIORITY_OR_EQUIVALENCE|The 2-sided CIs were examined against a non-inferiority margin of 0.67|Geometric mean ratio at day 43|0.861|||||TWO_SIDED|95.0|0.681|1.089|||||Pairwise Comparisons of GMTs (95% CI) Between Vaccination Groups at Day 43, on the pooled age groups.|Two-sided 95% CI around the point estimates were to be presented for each endpoint||1.089|0.681|
72382435|NCT00973349|144273620|NON_INFERIORITY_OR_EQUIVALENCE|The 2-sided CIs were examined against a non-inferiority margin of 0.67.|Geometric mean ratio at day 43|0.754|||||TWO_SIDED|95.0|0.596|0.956|||||Pairwise Comparisons of GMTs (95% CI) Between Vaccination Groups at Day 43, on the pooled age groups.|Two-sided 95% CI around the point estimates were to be presented for each endpoint||0.956|0.596|
72382436|NCT00973349|144273620|NON_INFERIORITY_OR_EQUIVALENCE|The 2-sided CIs were examined against a non-inferiority margin of 0.67.|Geometric mean ratio at day 43|0.548|||||TWO_SIDED|95.0|0.434|0.693|||||Pairwise Comparisons of GMTs (95% CI) Between Vaccination Groups at Day 43, on the pooled age groups.|Two-sided 95% CI around the point estimates were to be presented for each endpoint.||0.693|0.434|
72382437|NCT00973349|144273620|NON_INFERIORITY_OR_EQUIVALENCE|The 2-sided CIs were examined against a non-inferiority margin of 0.67|Geometric mean ratio at day 43|0.646|||||TWO_SIDED|95.0|0.51|0.817|||||Pairwise Comparisons of GMTs (95% CI) Between Vaccination Groups at Day 43, on the pooled age groups.|Two-sided 95% CI around the point estimates were to be presented for each endpoint.||0.817|0.510|
72382438|NCT00973349|144273620|NON_INFERIORITY_OR_EQUIVALENCE|The 2-sided CIs were examined against a non-inferiority margin of 0.67|Geometric mean ratio at 43|0.79|||||TWO_SIDED|95.0|0.625|1.0|||||Pairwise Comparisons of GMTs (95% CI) Between Vaccination Groups at Day 43, on the pooled age groups.|Two-sided 95% CI around the point estimates were to be presented for each endpoint.||1.000|0.625|
72382439|NCT00973349|144273620|NON_INFERIORITY_OR_EQUIVALENCE|The 2-sided CIs were examined against a non-inferiority margin of 0.67.|Geometric mean ratio at 43|0.56|||||TWO_SIDED|95.0|0.441|0.71|||||Pairwise Comparisons of GMTs (95% CI) Between Vaccination Groups at Day 43, on the pooled age groups.|Two-sided 95% CI around the point estimates were to be presented for each endpoint.||0.710|0.441|
72382440|NCT00973349|144273620|NON_INFERIORITY_OR_EQUIVALENCE|The 2-sided CIs were examined against a non-inferiority margin of 0.67.|Geometric mean ratio at 43|0.681|||||TWO_SIDED|95.0|0.538|0.862|||||Pairwise Comparisons of GMTs (95% CI) Between Vaccination Groups at Day 43, on the pooled age groups.|Two-sided 95% CI around the point estimates were to be presented for each endpoint.||0.862|0.538|
72382441|NCT00973349|144273620|NON_INFERIORITY_OR_EQUIVALENCE|The 2-sided CIs were examined against a non-inferiority margin of 0.67|Geometric mean ratio at 43|0.597|||||TWO_SIDED|95.0|0.47|0.757|||||Pairwise Comparisons of GMTs (95% CI) Between Vaccination Groups at Day 43, on the pooled age groups.|Two-sided 95% CI around the point estimates were to be presented for each endpoint.||0.757|0.470|
72434670|NCT02155829|144382709|SUPERIORITY|||||||0.0496|||||||ANCOVA|ANCOVA covariate included site.||||||0.0496
72434671|NCT00678795|144382711|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-0.11||||0.569|TWO_SIDED|95.0|-0.47|0.26|||ANCOVA|||The primary endpoint, the change in the number of incontinence episodes per day, was compared between treatment groups using analysis of covariance (ANCOVA). The model included treatment and centre as factors and baseline number of incontinence episodes per day as a covariate.||0.26|-0.47|0.569
72382442|NCT00973349|144273620|NON_INFERIORITY_OR_EQUIVALENCE|The 2-sided CIs were examined against a non-inferiority margin of 0.67|Geometric mean ratio at day 43|0.434|||||TWO_SIDED|95.0|0.342|0.549|||||Pairwise Comparisons of GMTs (95% CI) Between Vaccination Groups at Day 43, on the pooled age groups.|Two-sided 95% CI around the point estimates were to be presented for each endpoint.||0.549|0.342|
72382443|NCT00973349|144273620|NON_INFERIORITY_OR_EQUIVALENCE|The 2-sided CIs were examined against a non-inferiority margin of 0.67|Geometric mean ratio at day 43|0.511|||||TWO_SIDED|95.0|0.403|0.647|||||Pairwise Comparisons of GMTs (95% CI) Between Vaccination Groups at Day 43, on the pooled age groups.|Two-sided 95% CI around the point estimates were to be presented for each endpoint.||0.647|0.403|
72382444|NCT00973349|144273620|NON_INFERIORITY_OR_EQUIVALENCE|The 2-sided CIs were examined against a non-inferiority margin of 0.67|Geometric mean ratio at day 43|0.708|||||TWO_SIDED|95.0|0.56|0.896|||||Pairwise Comparisons of GMTs (95% CI) Between Vaccination Groups at Day 43, on the pooled age groups.|Two-sided 95% CI around the point estimates were to be presented for each endpoint.||0.896|0.560|
72434672|NCT00678795|144382712|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-0.76||||0.071|TWO_SIDED|95.0|-1.58|0.07|||ANCOVA|||The change in the number of urgency episodes per day was compared between treatment groups using ANCOVA. The model included treatment and centre as factors and baseline number of urgency episodes per day as a covariate.||0.07|-1.58|0.071
72557429|NCT00205777|144645420|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.157||||0.5|TWO_SIDED|95.0|0.71|1.885|||Log Rank|||At Least 1 Prevalent Fracture: P value was calculated using stratified log-rank test. Hazard ratio (Bazedoxifene 20 mg \[Core+SE I\] versus Bazedoxifene 40/20 mg \[SE I\]) based on a Cox proportional hazards regression model was presented along with 95% CIs.||1.885|0.710|0.50
72618685|NCT01026038|144768108|SUPERIORITY_OR_OTHER||GMT ratio|1.2|||||TWO_SIDED|95.0|0.23|6.25||||||Serotype 9V: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||6.25|0.23|
72382445|NCT00973349|144273620|NON_INFERIORITY_OR_EQUIVALENCE|The 2-sided CIs were examined against a non-inferiority margin of 0.67.|Geometric mean ratio at day 43|0.862|||||TWO_SIDED|95.0|0.683|1.088|||||Pairwise Comparisons of GMTs (95% CI) Between Vaccination Groups at Day 43, on the pooled age groups.|Two-sided 95% CI around the point estimates were to be presented for each endpoint.||1.088|0.683|
72382446|NCT00973349|144273620|NON_INFERIORITY_OR_EQUIVALENCE|The 2-sided CIs were examined against a non-inferiority margin of 0.67.|Geometric mean ratio at day 43|0.755|||||TWO_SIDED|95.0|0.597|0.954|||||Pairwise Comparisons of GMTs (95% CI) Between Vaccination Groups at Day 43, on the pooled age groups.|Two-sided 95% CI around the point estimates were to be presented for each endpoint||0.954|0.597|
72434673|NCT00678795|144382713|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-0.28||||0.01|TWO_SIDED|95.0|-0.5|-0.07|||ANCOVA|||The change in the number of nocturia episodes per day was compared between treatment groups using ANCOVA. The model included treatment and centre as factors and baseline number of nocturia episodes per day as a covariate.||-0.07|-0.50|0.010
72434674|NCT00678795|144382714|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-0.08||||0.74|TWO_SIDED|95.0|-0.57|0.41|||ANCOVA|||The change in the number of incontinence pads used per day was compared between treatment groups using ANCOVA. The model included treatment and centre as factors and baseline number of number of incontinence pads used per day as a covariate.||0.41|-0.57|0.74
72434675|NCT00678795|144382715|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|3.9||||0.166|TWO_SIDED|95.0|-1.65|9.46|||ANCOVA|||The change from baseline in the I-QOL score at the end of treatment was compared between treatment groups using ANCOVA. The model included treatment and centre as factors and baseline I-QOL score as a covariate.||9.46|-1.65|0.166
72434676|NCT00678795|144382716|SUPERIORITY_OR_OTHER_LEGACY||Slope|-1.16||||0.001|TWO_SIDED|95.0|-1.82|-0.51|||ANCOVA|||The change from baseline in the overall bladder condition Numerical Rating Scale score at the end of treatment was compared between treatment groups using ANCOVA. The model included treatment and centre as factors and baseline overall bladder condition Numerical Rating Scale score as a covariate.||-0.51|-1.82|0.001
72434677|NCT00678795|144382717|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|25.4||||0.002|TWO_SIDED|95.0|10.37|40.42|||Fisher Exact|||For Patient Global Impression of Change, the proportions of subjects who considered their condition 'Very Much Improved', 'Much Improved' or 'Minimally Improved' were compared between treatment groups using Fisher's Exact Test.||40.42|10.37|0.002
72434678|NCT00678795|144382718|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-0.85||||0.007|TWO_SIDED|95.0|-1.47|-0.23|||ANCOVA|||The change in the number of voids per day was compared between treatment groups using ANCOVA. The model included treatment and centre as factors and baseline number of voids per day as a covariate.||-0.23|-1.47|0.007
72434679|NCT00404079|144382726|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.5|STANDARD_DEVIATION|4.0||0.05|||||||Mixed Models Analysis|||Null hypothesis was glucosamine sulfate is not superior to placebo to reduce pain and disability associated with chronic low back pain. Power calculation was based on a 3 point difference between the groups with the primary outcome. Data was analysed with linear mixed models||||0.05
72434680|NCT00404079|144382726|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||Mixed Models Analysis|||||||0.05
72434681|NCT01120275|144382729|SUPERIORITY_OR_OTHER||6-month PFS|0.09|||||TWO_SIDED|95.0|0.02|0.22||||||6-month progression free survival (PFS) was estimated using the method of Kaplan-Meier and confidence intervals were calculated using the log-log transformation.||0.22|0.02|
72434682|NCT01120275|144382730|SUPERIORITY_OR_OTHER||1-year OS|0.5|||||TWO_SIDED|95.0|0.32|0.66||||||1-year overall survival (OS) was estimated using the method of Kaplan-Meier and confidence intervals were calculated using the log-log transformation.||0.66|0.32|
72434683|NCT02595398|144382736|SUPERIORITY||Difference in percentages|31.25|||<|0.001|TWO_SIDED|95.0|15.5|45.9||The a priori threshold for statistical significance was 0.050. Prior to evaluating the results of the CMH test, a Breslow-Day test with Tarone's adjustment was conducted to confirm the homogeneity of the odds ratios between country strata.|Cochran-Mantel-Haenszel|The CMH test was stratified by the country, i.e., US+Israel and India.|Estimated value was calculated as the percentage of subjects in the Active arm meeting the primary endpoint minus the percentage of subjects in the Control arm meeting the primary endpoint.|A total sample size of 150 subjects in a 3:2 randomization had 90% power to detect a difference between treatments in the proportion of subjects showing improvement is 0.60 for treated and 0.34 for sham. The primary analysis was a test of superiority of the CLS-TA arm over the sham arm, and was based on a Cochran-Mantel-Haenszel chi-square test stratified by country.||45.9|15.5|<0.001
72434684|NCT00414648|144382777|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||The model included the time since enrollment, the treatment assignment, and the interaction between time and treatment.|Regression, Linear|Mixed model with the use of the Kenward-Roger correction without imputation of missing data.||FEV1 slope||||<0.001
72434685|NCT00414648|144382778|OTHER|||||||0.441|||||||Chi-squared|||||||.441
72434686|NCT00414648|144382779|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|||||||Regression, Linear|GLM adjusted for baseline||||||0.001
72434687|NCT00414648|144382780|SUPERIORITY_OR_OTHER_LEGACY|||||||0.17|TWO_SIDED|95.0|||||Regression, Linear|GLM adjusted for baseline||||||0.17
72557430|NCT00205777|144645421|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.68||||0.085|TWO_SIDED|95.0|0.44|1.052|||Log Rank|||No Prevalent Fractures: P value was calculated using stratified log-rank test. Hazard ratio (Bazedoxifene 20 mg \[SE II\] versus Placebo \[Core+SE I+SE II\]) based on a Cox proportional hazards regression model was presented along with 95% CIs.||1.052|0.440|0.085
72557431|NCT00205777|144645421|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.61||||0.004|TWO_SIDED|95.0|0.434|0.857|||Log Rank|||At Least 1 Prevalent Fracture: P value was calculated using stratified log-rank test. Hazard ratio (Bazedoxifene 20 mg \[SE II\] versus Placebo \[Core+SE I+SE II\]) based on a Cox proportional hazards regression model was presented along with 95% CIs.||0.857|0.434|0.004
72618686|NCT01026038|144768108|SUPERIORITY_OR_OTHER||GMT ratio|0.8|||||TWO_SIDED|95.0|0.17|3.92||||||Serotype 9V: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||3.92|0.17|
72618687|NCT01026038|144768108|SUPERIORITY_OR_OTHER||GMT ratio|0.7|||||TWO_SIDED|95.0|0.11|4.43||||||Serotype 9V: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||4.43|0.11|
72434688|NCT00414648|144382781|SUPERIORITY|||||||0.34|||||||Regression, Linear|GLM adjusted for baseline||||||0.34
72434689|NCT00414648|144382782|SUPERIORITY_OR_OTHER_LEGACY|||||||0.88|||||||Regression, Linear|GLM adjusted for baseline||||||0.88
72434690|NCT00414648|144382783|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|||||||Regression, Linear|GLM adjusted for baseline||||||0.001
72434691|NCT01543685|144382852|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|441.8|STANDARD_ERROR_OF_MEAN|129.6|<|0.001|TWO_SIDED|95.0|187.1|696.5|||ANCOVA|||||696.5|187.1|<0.001
72434692|NCT01543685|144382852|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|260.2|STANDARD_ERROR_OF_MEAN|130.3||0.046|TWO_SIDED|95.0|4.1|516.3|||ANCOVA|||||516.3|4.1|0.046
72557432|NCT00205777|144645422|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.621||||0.4|TWO_SIDED|95.0|0.203|1.903|||Regression, Logistic|||P value was calculated using logistic regression. Gail index was added to the model to account for baseline risk differences between participants.||1.903|0.203|0.40
72557433|NCT00205777|144645422|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.504||||0.26|TWO_SIDED|95.0|0.151|1.676|||Regression, Logistic|||P value was calculated using logistic regression. Gail index was added to the model to account for baseline risk differences between participants.||1.676|0.151|0.26
72382447|NCT00973349|144273620|NON_INFERIORITY_OR_EQUIVALENCE|The 2-sided CIs were examined against a non-inferiority margin of 0.67|Geometric mean ratio at day 43|0.549|||||TWO_SIDED|95.0|0.435|0.692|||||Pairwise Comparisons of GMTs (95% CI) Between Vaccination Groups at Day 43, on the pooled age groups.|Two-sided 95% CI around the point estimates were to be presented for each endpoint||0.692|0.435|
72382448|NCT00973349|144273620|NON_INFERIORITY_OR_EQUIVALENCE|The 2-sided CIs were examined against a non-inferiority margin of 0.67|Geometric mean ratio at day 43|0.646|||||TWO_SIDED|95.0|0.511|0.817|||||Pairwise Comparisons of GMTs (95% CI) Between Vaccination Groups at Day 43, on the pooled age groups.|Two-sided 95% CI around the point estimates were to be presented for each endpoint||0.817|0.511|
72382449|NCT00973349|144273620|NON_INFERIORITY_OR_EQUIVALENCE|The 2-sided CIs were examined against a non-inferiority margin of 0.67|Geometric mean ratio at day 43|1.217|||||TWO_SIDED|95.0|0.961|1.541|||||Pairwise Comparisons of GMTs (95% CI) Between Vaccination Groups at Day 43, on the pooled age groups.|Two-sided 95% CI around the point estimates were to be presented for each endpoint||1.541|0.961|
72382450|NCT00973349|144273620|NON_INFERIORITY_OR_EQUIVALENCE|The 2-sided CIs were examined against a non-inferiority margin of 0.67|Geometric mean ratio at day 43|1.066|||||TWO_SIDED|95.0|0.841|1.352|||||Pairwise Comparisons of GMTs (95% CI) Between Vaccination Groups at Day 43, on the pooled age groups.|Two-sided 95% CI around the point estimates were to be presented for each endpoint||1.352|0.841|
72382451|NCT00973349|144273620|NON_INFERIORITY_OR_EQUIVALENCE|The 2-sided CIs were examined against a non-inferiority margin of 0.67.|Geometric mean ratio at day 43|0.775|||||TWO_SIDED|95.0|0.612|0.981|||||Pairwise Comparisons of GMTs (95% CI) Between Vaccination Groups at Day 43, on the pooled age groups.|Two-sided 95% CI around the point estimates were to be presented for each endpoint||0.981|0.612|
72382452|NCT00973349|144273620|NON_INFERIORITY_OR_EQUIVALENCE|The 2-sided CIs were examined against a non-inferiority margin of 0.67.|Geometric mean ratio at day 43|0.912|||||TWO_SIDED|95.0|0.719|1.157|||||Pairwise Comparisons of GMTs (95% CI) Between Vaccination Groups at Day 43, on the pooled age groups.|Two-sided 95% CI around the point estimates were to be presented for each endpoint.||1.157|0.719|
72382453|NCT00973349|144273620|NON_INFERIORITY_OR_EQUIVALENCE|The 2-sided CIs were examined against a non-inferiority margin of 0.67|Geometric mean ratio at day 43|0.876|||||TWO_SIDED|95.0|0.692|1.109|||||Pairwise Comparisons of GMTs (95% CI) Between Vaccination Groups at Day 43, on the pooled age groups.|Two-sided 95% CI around the point estimates were to be presented for each endpoint||1.109|0.692|
72382454|NCT00973349|144273620|NON_INFERIORITY_OR_EQUIVALENCE|The 2-sided CIs were examined against a non-inferiority margin of 0.67|Geometric mean ratio at day 43|0.637|||||TWO_SIDED|95.0|0.504|0.804|||||Pairwise Comparisons of GMTs (95% CI) Between Vaccination Groups at Day 43, on the pooled age groups.|Two-sided 95% CI around the point estimates were to be presented for each endpoint.||0.804|0.504|
72382455|NCT00973349|144273620|NON_INFERIORITY_OR_EQUIVALENCE|The 2-sided CIs were examined against a non-inferiority margin of 0.67|Geometric mean ratio at day 43|0.75|||||TWO_SIDED|95.0|0.593|0.949|||||Pairwise Comparisons of GMTs (95% CI) Between Vaccination Groups at Day 43, on the pooled age groups.|Two-sided 95% CI around the point estimates were to be presented for each endpoint.||0.949|0.593|
72382456|NCT00973349|144273620|NON_INFERIORITY_OR_EQUIVALENCE|The 2-sided CIs were examined against a non-inferiority margin of 0.67|Geometric mean ratio at day 43|0.727|||||TWO_SIDED|95.0|0.574|0.919|||||Pairwise Comparisons of GMTs (95% CI) Between Vaccination Groups at Day 43, on the pooled age groups.|Two-sided 95% CI around the point estimates were to be presented for each endpoint||0.919|0.574|
72382457|NCT00973349|144273620|NON_INFERIORITY_OR_EQUIVALENCE|The 2-sided CIs were examined against a non-inferiority margin of 0.67|Geometric mean ratio at day 43|0.856|||||TWO_SIDED|95.0|0.675|1.084|||||Pairwise Comparisons of GMTs (95% CI) Between Vaccination Groups at Day 43, on the pooled age groups.|Two-sided 95% CI around the point estimates were to be presented for each endpoint||1.084|0.675|
72434693|NCT01543685|144382852|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|312.7|STANDARD_ERROR_OF_MEAN|130.4||0.017|TWO_SIDED|95.0|56.6|568.9|||ANCOVA|||||568.9|56.6|0.017
72557434|NCT00205777|144645422|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.54||||0.33|TWO_SIDED|95.0|0.157|1.86|||Regression, Logistic|||P value was calculated using logistic regression. Gail index was added to the model to account for baseline risk differences between participants.||1.860|0.157|0.33
72557435|NCT00205777|144645422|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.661||||0.49|TWO_SIDED|95.0|0.206|2.118|||Regression, Logistic|||P value was calculated using logistic regression. Gail index was added to the model to account for baseline risk differences between participants.||2.118|0.206|0.49
72382458|NCT00973349|144273620|NON_INFERIORITY_OR_EQUIVALENCE|The 2-sided CIs were examined against a non-inferiority margin of 0.67|Geometric mean ratio at day 43|1.178|||||TWO_SIDED|95.0|0.931|1.489|||||Pairwise Comparisons of GMTs (95% CI) Between Vaccination Groups at Day 43, on the pooled age groups.|Two-sided 95% CI around the point estimates were to be presented for each endpoint.||1.489|0.931|
72382459|NCT02301988|144273629|SUPERIORITY||Difference in Response Rates|3.77||||0.519||95.0|-8.99|16.54|||Chi-squared||95% CI for difference in rates were constructed using normal approximation (Wald) with continuity correction.|Unstratified Analysis||16.54|-8.99|0.519
72382460|NCT02301988|144273630|SUPERIORITY||Difference in response rates|3.29||||0.7817|TWO_SIDED|95.0|-25.52|32.1|||Chi-squared||95% CI for difference in rates were constructed using normal approximation (Wald) with continuity correction.|Unstratified analysis||32.10|-25.52|0.7817
72382461|NCT02301988|144273631|SUPERIORITY||Difference in Response Rates|7.7||||0.2234|TWO_SIDED|95.0|-5.95|21.35|||Chi-squared||95% CI for difference in rates were constructed using normal approximation (Wald) with continuity correction.|Unstratified analysis||21.35|-5.95|0.2234
72434694|NCT01543685|144382852|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|211.6|STANDARD_ERROR_OF_MEAN|129.6||0.103|TWO_SIDED|95.0|-43.1|466.2|||ANCOVA|||||466.2|-43.1|0.103
72434695|NCT01543685|144382853|SUPERIORITY_OR_OTHER|||||||0.013||95.0|||||t-test, 2 sided|||||||0.013
72434696|NCT01543685|144382853|SUPERIORITY_OR_OTHER|||||||0.014||95.0|||||t-test, 2 sided|||||||0.014
72382462|NCT02301988|144273632|SUPERIORITY||Difference in response rates|-2.96||||0.8169|TWO_SIDED|95.0|-33.91|27.99|||Chi-squared||95% CI for difference in rates were constructed using normal approximation (Wald) with continuity correction.|Unstratified analysis||27.99|-33.91|0.8169
72382463|NCT02301988|144273633|SUPERIORITY||Difference in response rate|11.11||||0.1607||95.0|-5.64|27.85|||Chi-squared||95% CI for difference in rates were constructed using normal approximation (Wald) with continuity correction.|Unstratified analysis||27.85|-5.64|0.1607
72382464|NCT02301988|144273634|SUPERIORITY||Difference in Response Rates|23.68||||0.1486|TWO_SIDED|95.0|-13.57|60.94|||Chi-squared||95% CI for difference in rates were constructed using normal approximation (Wald) with continuity correction.|Unstratified Analysis||60.94|-13.57|0.1486
72382465|NCT02301988|144273635|SUPERIORITY||Difference in Response Rates|6.09||||0.498|TWO_SIDED|95.0|-15.01|27.2|||Chi-squared||95% CI for difference in rates were constructed using normal approximation (Wald) with continuity correction method.|||27.20|-15.01|0.4980
72382466|NCT02301988|144273636|SUPERIORITY||Difference in Response Rates|9.66||||0.3032||95.0|-12.25|31.58|||Chi-squared||95% CI for difference in rates were constructed using normal approximation (Wald) with continuity correction method.|||31.58|-12.25|0.3032
72382467|NCT02301988|144273638|SUPERIORITY||Difference in Response Rates|4.2||||0.628|TWO_SIDED|95.0|-14.37|22.76|||Chi-squared||95% CI for difference in rates were constructed using normal approximation (Wald) with continuity correction method.|||22.76|-14.37|0.6280
72382468|NCT02301988|144273639|SUPERIORITY||Difference in Response Rates|8.33||||0.6291|TWO_SIDED|95.0|-33.04|49.71|||Chi-squared||95% CI for difference in rates were constructed using normal approximation (Wald) with continuity correction method.|||49.71|-33.04|0.6291
72382469|NCT02750943|144273643|SUPERIORITY_OR_OTHER||Least square (LS) mean difference|-25.34|||<|0.0001|TWO_SIDED|95.0|-30.682|-19.998||From ANCOVA analysis with treatment group, gender and baseline MGI stratification as factors baseline as covariates.|ANCOVA||Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|||-19.998|-30.682|<0.0001
72382470|NCT02452697|144273677|SUPERIORITY|||||||0.4|||||||Log Rank|||||||0.40
72382471|NCT03552965|144273691|OTHER||||||||||||||||||"Descriptive statistics were used to evaluate the prevalence and grade of xerostomia over time.~Margin-based: Mean=1.14, SD=0.378, Range=1, 25th percentile=1, Median=1, 75th percentile=1, n=7 Robust: Mean=1.17, SD=0.577, Range=2, 25th percentile=1, Median=1, 75th percentile=1, n=12"|||
72382472|NCT03552965|144273692|OTHER||||||||||||||||||"Descriptive statistics were used to evaluate the prevalence and grade of xerostomia over time.~Margin-based: Mean=2, SD=0.894, Range=2, 25th percentile=1, Median=2, 75th percentile=3, n=6 Robust: Mean=2.91, SD=1.136, Range=3, 25th percentile=2, Median=3, 75th percentile=4, n=11"|||
72434697|NCT01543685|144382853|SUPERIORITY_OR_OTHER|||||||0.211||95.0|||||t-test, 2 sided|||||||0.211
72382473|NCT03552965|144273693|OTHER||||||||||||||||||"Descriptive statistics were used to evaluate the prevalence and grade of xerostomia over time.~Margin-based: Mean=2.5, SD=0.577, Range=1, 25th percentile=2, Median=2.5, 75th percentile=3, n=4 Robust: Mean=2.33, SD=1.225, Range=3, 25th percentile=1, Median=2, 75th percentile=3.5, n=9"|||
72382474|NCT03552965|144273694|OTHER||||||||||||||||||"Descriptive statistics were used to evaluate the prevalence and grade of xerostomia over time.~Margin-based: Mean=1.83, SD=0.753, Range=2, 25th percentile=1, Median=2, 75th percentile=2.25, n=6 Robust: Mean=2.33, SD=1, Range=3, 25th percentile=1.5, Median=2, 75th percentile=3, n=9"|||
72382475|NCT03552965|144273695|OTHER||||||||||||||||||"Descriptive statistics were used to evaluate the prevalence and grade of xerostomia over time.~Margin-based: Mean=2, SD=0.707, Range=2, 25th percentile=1.5, Median=2, 75th percentile=2.5, n=5 Robust: Mean=2.38, SD=1.188, Range=3, 25th percentile=1.25, Median=2, 75th percentile=3.75, n=8"|||
72382476|NCT03552965|144273696|OTHER||||||||||||||||||"Descriptive statistics were used to evaluate the prevalence and grade of xerostomia over time.~Margin-based: Mean=15.5, SD=23.76242, Range=75, 25th percentile=0, Median=5, 75th percentile=21.25, n=10 Robust: Mean=14.1346, SD=17.87095, Range=52.5, 25th percentile=0, Median=6.25, 75th percentile=27.5, n=13"|||
72382477|NCT03552965|144273697|OTHER||||||||||||||||||"Descriptive statistics were used to evaluate the prevalence and grade of xerostomia over time.~Margin-based: Mean=45.625, SD=30.68744, Range=71.25, 25th percentile=11.25, Median=58.125, 75th percentile=71.25, n=6 Robust: Mean=64.3182, SD=15.0142, Range=48.75, 25th percentile=66.25, Median=70, 75th percentile=71.25, n=11"|||
72382478|NCT03552965|144273698|OTHER||||||||||||||||||"Descriptive statistics were used to evaluate the prevalence and grade of xerostomia over time.~Margin-based: Mean=60, SD=23.68412, Range=60, 25th percentile=38.125, Median=68.75, 75th percentile=77.5, n=5 Robust: Mean=54.8611, SD=29.91815, Range=80, 25th percentile=24.375, Median=66.25, 75th percentile=80, n=9"|||
72382479|NCT03552965|144273699|OTHER||||||||||||||||||"Descriptive statistics were used to evaluate the prevalence and grade of xerostomia over time.~Margin-based: Mean=31.67, SD=31.38139, Range=85, 25th percentile=5.625, Median=25, 75th percentile=56.875, n=6 Robust: Mean=54.0278, SD=24.57274, Range=67.5, 25th percentile=33.75, Median=62.5, 75th percentile=72.5, n=9"|||
72382480|NCT03552965|144273700|OTHER||||||||||||||||||"Descriptive statistics were used to evaluate the prevalence and grade of xerostomia over time.~Margin-based: Mean=50.75, SD=30.29284, Range=72.5, 25th percentile=21.875, Median=48.75, 75th percentile=80.625, n=5 Robust: Mean=38.4375, SD=26.69897, Range=66.25, 25th percentile=15, Median=29.375, 75th percentile=68.75, n=8"|||
72382481|NCT02477696|144273701|NON_INFERIORITY|Non-inferiority of acalabrutinib was demonstrated if the upper bound of the 2-sided 95% confidence interval (CI) of the hazard ratio was below 1.429.|Hazard Ratio (HR)|1.0|||||TWO_SIDED|95.0|0.79|1.27|||||Cox Proportional Hazards model stratified by 17p deletion status (yes versus no) and number of prior therapies (1-3 versus \>=4).|||1.27|0.79|
72382482|NCT05419908|144273713|SUPERIORITY||LSMean Difference|-12.34|||<|0.001|TWO_SIDED|95.0|-16.89|-7.79||Least square (LS) mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline weekly hot flash score as covariate. P-value of the t-statistic testing whether there is a treatment difference.|ANCOVA|Analysis of Covariance (ANCOVA)||||-7.79|-16.89|<0.001
72382483|NCT05419908|144273714|SUPERIORITY||LSMean Difference|-1.134|||<|0.001|TWO_SIDED|95.0|-1.466|-0.802||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline weekly hot flash score as covariate. P-value of the t-statistic testing whether there is a treatment difference.|ANCOVA|||Week 4||-0.802|-1.466|<0.001
72434698|NCT01543685|144382853|SUPERIORITY_OR_OTHER|||||||0.098||95.0|||||t-test, 2 sided|||||||0.098
72434699|NCT01543685|144382854|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||t-test, 2 sided|||||||0.001
72434700|NCT01543685|144382854|SUPERIORITY_OR_OTHER|||||||0.004||95.0|||||t-test, 2 sided|||||||0.004
72434701|NCT01543685|144382854|SUPERIORITY_OR_OTHER|||||||0.017||95.0|||||t-test, 2 sided|||||||0.017
72434702|NCT01543685|144382854|SUPERIORITY_OR_OTHER|||||||0.028||95.0|||||t-test, 2 sided|||||||0.028
72434703|NCT01543685|144382855|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||||||<0.001
72434704|NCT01543685|144382855|SUPERIORITY_OR_OTHER|||||||0.004||95.0|||||t-test, 2 sided|||||||0.004
72434705|NCT01543685|144382855|SUPERIORITY_OR_OTHER|||||||0.004||95.0|||||t-test, 2 sided|||||||0.004
72434706|NCT01543685|144382855|SUPERIORITY_OR_OTHER|||||||0.015||95.0|||||t-test, 2 sided|||||||0.015
72434707|NCT01543685|144382856|SUPERIORITY_OR_OTHER|||||||0.003||95.0|||||t-test, 2 sided|||||||0.003
72434708|NCT01543685|144382856|SUPERIORITY_OR_OTHER|||||||0.022||95.0|||||t-test, 2 sided|||||||0.022
72434709|NCT01543685|144382856|SUPERIORITY_OR_OTHER|||||||0.146||95.0|||||t-test, 2 sided|||||||0.146
72434710|NCT01543685|144382856|SUPERIORITY_OR_OTHER|||||||0.071||95.0|||||t-test, 2 sided|||||||0.071
72434711|NCT01543685|144382857|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||||||<0.001
72618688|NCT01026038|144768108|SUPERIORITY_OR_OTHER||GMT ratio|2.4|||||TWO_SIDED|95.0|0.48|12.35||||||Serotype 14: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||12.35|0.48|
72382484|NCT05419908|144273714|SUPERIORITY||LSMean Difference|-0.948|||<|0.001||95.0|-1.362|-0.535||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline weekly hot flash score as covariate. P-value of the t-statistic testing whether there is a treatment difference.|ANCOVA|||Week 8||-0.535|-1.362|<0.001
72382485|NCT05419908|144273714|SUPERIORITY||LSMean Difference|-1.122|||<|0.001|TWO_SIDED|95.0|-1.504|-0.741||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline weekly hot flash score as covariate. P-value of the t-statistic testing whether there is a treatment difference.|ANCOVA|||Week 12||-0.741|-1.504|<0.001
72382486|NCT05419908|144273715|SUPERIORITY||LSMean Difference|-13.28|||<|0.001||95.0|-17.02|-9.54||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline weekly hot flash score as covariate. P-value of the t-statistic testing whether there is a treatment difference.|ANCOVA|||Week 4||-9.54|-17.02|<0.001
72382487|NCT05419908|144273715|SUPERIORITY||LSMean Difference|-11.78|||<|0.001|TWO_SIDED|95.0|-16.3|-7.27||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline weekly hot flash score as covariate. P-value of the t-statistic testing whether there is a treatment difference.|ANCOVA|||Week 8||-7.27|-16.30|<0.001
72382488|NCT05419908|144273715|SUPERIORITY||LSMean Difference|-12.42|||<|0.001||95.0|-17.0|-7.83||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline weekly hot flash score as covariate. P-value of the t-statistic testing whether there is a treatment difference.|ANCOVA|||Week 12||-7.83|-17.00|<0.001
72382489|NCT05419908|144273716|SUPERIORITY||LSMean Difference|-39.8|||<|0.001|TWO_SIDED|95.0|-50.5|-29.1||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as factor. P-value of the t-statistic testing whether there is a treatment difference.|ANCOVA|||Week 4||-29.1|-50.5|<0.001
72382490|NCT05419908|144273716|SUPERIORITY||LSMean Difference|-35.5|||<|0.001|TWO_SIDED|95.0|-47.9|-23.0||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as factor. P-value of the t-statistic testing whether there is a treatment difference.|ANCOVA|||Week 8||-23.0|-47.9|<0.001
72434712|NCT01543685|144382857|SUPERIORITY_OR_OTHER|||||||0.008||95.0|||||t-test, 2 sided|||||||0.008
72434713|NCT01543685|144382857|SUPERIORITY_OR_OTHER|||||||0.01||95.0|||||t-test, 2 sided|||||||0.010
72434714|NCT01543685|144382857|SUPERIORITY_OR_OTHER|||||||0.016||95.0|||||t-test, 2 sided|||||||0.016
72434715|NCT01543685|144382858|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||||||<0.001
72434716|NCT01543685|144382858|SUPERIORITY_OR_OTHER|||||||0.008||95.0|||||t-test, 2 sided|||||||0.008
72434717|NCT01543685|144382858|SUPERIORITY_OR_OTHER|||||||0.005||95.0|||||t-test, 2 sided|||||||0.005
72434718|NCT01543685|144382858|SUPERIORITY_OR_OTHER|||||||0.017||95.0|||||t-test, 2 sided|||||||0.017
72434719|NCT01543685|144382859|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||||||<0.001
72434720|NCT01543685|144382859|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||t-test, 2 sided|||||||0.020
72434721|NCT01543685|144382859|SUPERIORITY_OR_OTHER|||||||0.012||95.0|||||t-test, 2 sided|||||||0.012
72434722|NCT01543685|144382859|SUPERIORITY_OR_OTHER|||||||0.029||95.0|||||t-test, 2 sided|||||||0.029
72434723|NCT02931396|144382863|SUPERIORITY||Mean Difference (Net)|2.3||||0.768|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.768
72434724|NCT02931396|144382864|SUPERIORITY||Mean Difference (Net)|25.5||||1|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||1
72434725|NCT02931396|144382865|SUPERIORITY||Mean Difference (Net)|2.7||||0.03|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.03
72434726|NCT01304147|144382874|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.6|||<|0.001|TWO_SIDED|95.0|3.9|11.3|||Paired t-test, 2 sided|||within-subject crossover design||11.3|3.9|<0.001
72434727|NCT01278862|144382885|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2423|||||||Fisher Exact|||null hypothesis no difference in color match||||0.2423
72434728|NCT01278862|144382885|SUPERIORITY||||||>|0.999|||||||Fisher Exact|||null hypothesis no difference in margin discoloration||||>0.999
72434729|NCT01278862|144382885|SUPERIORITY||||||>|0.999|||||||Fisher Exact|||null hypothesis no difference in crown fracture||||>0.999
72434730|NCT01278862|144382885|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.999|||||||Fisher Exact|||Null hypothesis no difference in Proximal Contact - Mesial||||>0.999
72434731|NCT01278862|144382885|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.999|||||||Fisher Exact|||Null hypothesis no difference in proximal contact - distal||||>0.999
72434732|NCT01278862|144382886|SUPERIORITY||||||>|0.999|||||||Fisher Exact|||null hypothesis no difference in gingival index||||>0.999
72434733|NCT01278862|144382886|SUPERIORITY|||||||0.524|||||||Fisher Exact|||null hypothesis no difference in plaque index||||0.5240
72434734|NCT04341298|144382889|SUPERIORITY|||||||0.65|||||||Wilcoxon (Mann-Whitney)|||||||0.65
72434735|NCT04341298|144382890|SUPERIORITY|||||||0.87|||||||t-test, 2 sided|||||||0.87
72618689|NCT01026038|144768108|SUPERIORITY_OR_OTHER||GMT ratio|2.0|||||TWO_SIDED|95.0|0.45|9.05||||||Serotype 14: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||9.05|0.45|
72382491|NCT05419908|144273716|SUPERIORITY||LSMean Difference|-35.0|||<|0.001||95.0|-47.9|-22.1||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as factor. P-value of the t-statistic testing whether there is a treatment difference.|ANCOVA|||Week 12||-22.1|-47.9|<0.001
72382492|NCT05419908|144273717|SUPERIORITY||Percentage Difference|65.1|||<|0.001|TWO_SIDED|95.0|49.15|81.0||Likelihood-ratio test based 95% confidence interval of the percentage difference.|Likelihood-Ratio Chi-Square Test|||Week 4||81.00|49.15|<0.001
72382493|NCT05419908|144273717|SUPERIORITY||Percentage Difference|48.5|||<|0.001||95.0|30.37|66.59||Likelihood-ratio test based 95% confidence interval of the percentage difference.|Likelihood-Ratio Chi-Square Test|||Week 8||66.59|30.37|<0.001
72382494|NCT05419908|144273717|SUPERIORITY||Percentage Difference|52.5|||<|0.001|TWO_SIDED|95.0|35.76|69.24||Likelihood-ratio test based 95% confidence interval of the percentage difference.|Likelihood-Ratio Chi-Square Test|||Week 12||69.24|35.76|<0.001
72382495|NCT05419908|144273718|SUPERIORITY||Percentage Difference|69.0|||<|0.001|TWO_SIDED|95.0|53.7|84.21||Likelihood-ratio test based 95% confidence interval of the percentage difference.|Likelihood-Ratio Chi-Square Test|||Week 4||84.21|53.70|<0.001
72382496|NCT05419908|144273718|SUPERIORITY||Percentage Difference|50.7|||<|0.001||95.0|31.93|69.42||Likelihood-ratio test based 95% confidence interval of the percentage difference|Likelihood-Ratio Chi-Square Test|||Week 8||69.42|31.93|<0.001
72382497|NCT05419908|144273718|SUPERIORITY||Percentage Difference|57.5|||<|0.001|TWO_SIDED|95.0|39.99|75.01||Likelihood-ratio test based 95% confidence interval of the percentage difference|Likelihood-Ratio Chi-Square Test|||Week 12||75.01|39.99|<0.001
72382498|NCT05419908|144273719|SUPERIORITY||Percentage Difference|54.2|||<|0.001|TWO_SIDED|95.0|37.47|70.84||Likelihood-ratio test based 95% confidence interval of the percentage difference.|Likelihood-Ratio Chi-Square Test|||Week 4||70.84|37.47|<0.001
72382499|NCT05419908|144273719|SUPERIORITY||Percentage Difference|47.8|||<|0.001||95.0|29.62|65.99||Likelihood-ratio test based 95% confidence interval of the percentage difference.|Likelihood-Ratio Chi-Square Test|||Week 8||65.99|29.62|<0.001
72382500|NCT05419908|144273719|SUPERIORITY||Percentage Difference|47.5|||<|0.001||95.0|28.86|66.14||Likelihood-ratio test based 95% confidence interval of the percentage difference.|Likelihood-Ratio Chi-Square Test|||Week 12||66.14|28.86|<0.001
72382501|NCT05419908|144273720|SUPERIORITY||Percentage Difference|49.7|||<|0.001||95.0|33.54|65.79||Likelihood-ratio test based 95% confidence interval of the percentage difference.|Likelihood-Ratio Chi-Square Test|||Week 4||65.79|33.54|<0.001
72434736|NCT04341298|144382891|SUPERIORITY|||||||0.66|||||||Mantel Haenszel|Subjects were stratified based on baseline pain score (6-7 vs. 8-10) prior to analysis using Cochran-Mantel-Haenszel test||Each subject was stratified by baseline pain score for the first severe headache that they experienced (score of 6-7 vs. 8-10). The total number of subjects, and the number of subjects with a pain score of 3 or less after 2 hours, were tabulated within each stratum. A Cochran-Mantel-Haenszel test was conducted to test the hypothesis of lack of association between the proportion of subjects reporting mild or no symptoms after 2 hours and the type of device, across all strata.||||0.66
72434737|NCT04341298|144382892|SUPERIORITY|||||||0.59|||||||Mantel Haenszel|Subjects were stratified based on baseline pain score (6-7 vs. 8-10) prior to analysis using Cochran-Mantel-Haenszel test||Each subject was stratified by baseline pain score for the first severe headache that they experienced (score of 6-7 vs. 8-10). The total number of subjects, and the number of subjects requiring abortive medication within 8 hours were tabulated within each stratum. A Cochran-Mantel-Haenszel test was conducted to test the hypothesis of lack of association between the proportion of subjects requiring abortive medication within 8 hours and the type of device, across all strata.||||0.59
72557436|NCT00205777|144645422|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.85||||0.76|TWO_SIDED|95.0|0.305|2.37|||Regression, Logistic|||P value was calculated using logistic regression. Gail index was added to the model to account for baseline risk differences between participants.||2.370|0.305|0.76
72382502|NCT05419908|144273720|SUPERIORITY||Percentage Difference|43.8|||<|0.001|TWO_SIDED|95.0|27.83|59.85||Likelihood-ratio test based 95% confidence interval of the percentage difference.|Likelihood-Ratio Chi-Square Test|||Week 8||59.85|27.83|<0.001
72382503|NCT05419908|144273720|SUPERIORITY||Percentage Difference|42.5|||<|0.001||95.0|26.34|58.66||Likelihood-ratio test based 95% confidence interval of the percentage difference.|Likelihood-Ratio Chi-Square Test|||Week 12||58.66|26.34|<0.001
72382504|NCT05419908|144273721|SUPERIORITY||Percentage Difference|62.8|||<|0.001|TWO_SIDED|95.0|46.56|79.05||Likelihood-ratio test based 95% confidence interval of the percentage difference.|Likelihood-Ratio Chi-Square Test|||Week 4||79.05|46.56|<0.001
72382505|NCT05419908|144273721|SUPERIORITY||Percentage Difference|46.2|||<|0.001|TWO_SIDED|95.0|28.85|63.47||Likelihood-ratio test based 95% confidence interval of the percentage difference.|Likelihood-Ratio Chi-Square Test|||Week 8||63.47|28.85|<0.001
72382506|NCT05419908|144273721|SUPERIORITY||Percentage Difference|57.5|||<|0.001|TWO_SIDED|95.0|41.57|73.43||Likelihood-ratio test based 95% confidence interval of the percentage difference.|Likelihood-Ratio Chi-Square Test|||Week 12||73.43|41.57|<0.001
72382507|NCT05419908|144273722|SUPERIORITY||Percentage Difference|61.5|||<|0.001||95.0|45.4|77.55||Likelihood-ratio test based 95% confidence interval of the percentage difference.|Likelihood-Ratio Chi-Square Test|||Week 4||77.55|45.40|<0.001
72382508|NCT05419908|144273722|SUPERIORITY||Percentage Difference|43.1|||<|0.001|TWO_SIDED|95.0|23.53|62.69||Likelihood-ratio test based 95% confidence interval of the percentage difference.|Likelihood-Ratio Chi-Square Test|||Week 8||62.69|23.53|<0.001
72382509|NCT05419908|144273722|SUPERIORITY||Percentage Difference|52.5|||<|0.001||95.0|33.92|71.08||Likelihood-ratio test based 95% confidence interval of the percentage difference.|Likelihood-Ratio Chi-Square Test|||Week 12||71.08|33.92|<0.001
72382510|NCT05419908|144273723|SUPERIORITY||LSMean Difference|-2.53|||<|0.001|TWO_SIDED|95.0|-3.45|-1.6||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline weekly hfrdis as covariate.|ANCOVA|||Week 4: Work||-1.60|-3.45|<0.001
72382511|NCT05419908|144273723|SUPERIORITY||LSMean Difference|-2.29|||<|0.001|TWO_SIDED|95.0|-3.15|-1.42||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline weekly hfrdis as covariate.|ANCOVA|||Week 8: Work||-1.42|-3.15|<0.001
72382512|NCT05419908|144273723|SUPERIORITY||LSMean Difference|-2.11|||<|0.001|TWO_SIDED|95.0|-3.03|-1.2||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline weekly hfrdis as covariate.|ANCOVA|||Week 12: Work||-1.20|-3.03|<0.001
72494089|NCT01390909|144517164|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|83.0|||<|0.0001|TWO_SIDED|95.0|58.0|113.0||Adjusted Cost Differences in Other Epilepsy-Related Healthcare Costs|Ordinary Least Squares Regression|Ordinary least squares regression was used to adjust differences. Covariates were gender, age, region, comorbidities, baseline treatment, and costs.|Confidence intervals were calculated using a nonparametric bootstrap with 999 replications.|||113|58|<0.0001
72382513|NCT05419908|144273723|SUPERIORITY||LSMean Difference|-2.33|||<|0.001|TWO_SIDED|95.0|-3.19|-1.46||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline weekly hfrdis as covariate.|ANCOVA|||Week 4: Social Activities||-1.46|-3.19|<0.001
72382514|NCT05419908|144273723|SUPERIORITY||LSMean Difference|-2.34|||<|0.001|TWO_SIDED|95.0|-3.21|-1.47||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline weekly hfrdis as covariate.|ANCOVA|||Week 8: Social Activties||-1.47|-3.21|<0.001
72382515|NCT05419908|144273723|SUPERIORITY||LSMean Difference|-2.19|||<|0.001|TWO_SIDED|95.0|-3.09|-1.29||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline weekly hfrdis as covariate.|ANCOVA|||Week 12: Social Activties||-1.29|-3.09|<0.001
72382516|NCT05419908|144273723|SUPERIORITY||LSMean Difference|-2.15|||<|0.001|TWO_SIDED|95.0|-2.99|-1.31||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline weekly hfrdis as covariate.|ANCOVA|||Week 4: Leisure Activities||-1.31|-2.99|<0.001
72382517|NCT05419908|144273723|SUPERIORITY||LSMean Difference|-2.37|||<|0.001|TWO_SIDED|95.0|-3.19|-1.55||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline weekly hfrdis as covariate.|ANCOVA|||Week 8: Leisure Activties||-1.55|-3.19|<0.001
72382518|NCT05419908|144273723|SUPERIORITY||LSMean Difference|-1.64||||0.002|TWO_SIDED|95.0|-2.66|-0.62||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline weekly hfrdis as covariate.|ANCOVA|||Week 12: Leisure Activties||-0.62|-2.66|0.002
72382519|NCT05419908|144273723|SUPERIORITY||LSMean Difference|-2.93|||<|0.001|TWO_SIDED|95.0|-4.08|-1.78||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline weekly hfrdis as covariate.|ANCOVA|||Week 4: Sleep||-1.78|-4.08|<0.001
72382520|NCT05419908|144273723|SUPERIORITY||LSMean Difference|-2.71|||<|0.001|TWO_SIDED|95.0|-3.86|-1.57||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline weekly hfrdis as covariate.|ANCOVA|||Week 8: Sleep||-1.57|-3.86|<0.001
72382521|NCT05419908|144273723|SUPERIORITY||LSMean Difference|-2.61|||<|0.001|TWO_SIDED|95.0|-3.67|-1.54||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline weekly hfrdis as covariate.|ANCOVA|||Week 12: Sleep||-1.54|-3.67|<0.001
72382522|NCT05419908|144273723|SUPERIORITY||LSMean Difference|-1.74|||<|0.001|TWO_SIDED|95.0|-2.67|-0.81||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline weekly hfrdis as covariate.|ANCOVA|||Week 4: Mood||-0.81|-2.67|<0.001
72382523|NCT05419908|144273723|SUPERIORITY||LSMean Difference|-2.12|||<|0.001|TWO_SIDED|95.0|-3.09|-1.16||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline weekly hfrdis as covariate.|ANCOVA|||Week 8: Mood||-1.16|-3.09|<0.001
72494090|NCT01390909|144517164|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14582.0|||<|0.0001|TWO_SIDED|95.0|12019.0|17097.0||Adjusted Cost Differences in Total Healthcare Costs|Ordinary Least Squares Regression|Covariates were gender, age, region, comorbidities, AEDs and non-AEDs known to increase seizure risk and baseline costs.||||17097|12019|<0.0001
72494091|NCT01390909|144517164|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|420.0|||<|0.0001|TWO_SIDED|95.0|210.0|630.0||Adjusted Cost Differences in Prescription Drug Costs, AEDs|Ordinary Least Squares Regression|Covariates were gender, age, region, comorbidities, AEDs and non-AEDs known to increase seizure risk and baseline costs.||||630|210|<0.0001
72382524|NCT05419908|144273723|SUPERIORITY||LSMean Difference|-1.79|||<|0.001|TWO_SIDED|95.0|-2.69|-0.88||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline weekly hfrdis as covariate.|ANCOVA|||Week 12: Mood||-0.88|-2.69|<0.001
72382525|NCT05419908|144273723|SUPERIORITY||LSMean Difference|-1.92|||<|0.001|TWO_SIDED|95.0|-2.86|-0.97||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline weekly hfrdis as covariate.|ANCOVA|||Week 4: Concentration||-0.97|-2.86|<0.001
72382526|NCT05419908|144273723|SUPERIORITY||LSMean Difference|-2.23|||<|0.001|TWO_SIDED|94.0|-3.21|-1.25||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline weekly hfrdis as covariate.|ANCOVA|||Week 8: Concentration||-1.25|-3.21|<0.001
72382527|NCT05419908|144273723|SUPERIORITY||LSMean Difference|-1.9|||<|0.001|TWO_SIDED|95.0|-2.91|-0.88||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline weekly hfrdis as covariate.|ANCOVA|||Week 12: Concentration||-0.88|-2.91|<0.001
72382528|NCT05419908|144273723|SUPERIORITY||LSMean Difference|-1.33||||0.003|TWO_SIDED|95.0|-2.2|-0.46||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline weekly hfrdis as covariate.|ANCOVA|||Week 4: Relations With Others||-0.46|-2.20|0.003
72382529|NCT05419908|144273723|SUPERIORITY||LSMean Difference|-1.85|||<|0.001|TWO_SIDED|95.0|-2.8|-0.9||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline weekly hfrdis as covariate.|ANCOVA|||Week 8: Relations With others||-0.90|-2.80|<0.001
72382530|NCT05419908|144273723|SUPERIORITY||LSMean Difference|-1.72|||<|0.001|TWO_SIDED|95.0|-2.66|-0.77||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline weekly hfrdis as covariate.|ANCOVA|||Week 12: Relations With Others||-0.77|-2.66|<0.001
72434738|NCT04341298|144382893|SUPERIORITY|||||||0.19|||||||Mantel Haenszel|Subjects were stratified based on baseline pain score (6-7 vs. 8-10) prior to analysis using Cochran-Mantel-Haenszel test||Each subject was stratified by baseline pain score for the first severe headache that they experienced (score of 6-7 vs. 8-10). The total number of subjects, and the number of subjects experiencing light sensitivity after 2 hours, were tabulated within each stratum. A Cochran-Mantel-Haenszel test was conducted to test the hypothesis of lack of association between the proportion of subjects reporting light sensitivity after 2 hours and the type of device, across all strata.||||0.19
72434739|NCT04341298|144382894|SUPERIORITY|||||||1|||||||Mantel Haenszel|Subjects were stratified based on baseline pain score (6-7 vs. 8-10) prior to analysis using Cochran-Mantel-Haenszel test||Each subject was stratified by baseline pain score for the first severe headache that they experienced (score of 6-7 vs. 8-10). The total number of subjects, and the number of subjects experiencing light sensitivity after 4 hours, were tabulated within each stratum. A Cochran-Mantel-Haenszel test was conducted to test the hypothesis of lack of association between the proportion of subjects reporting light sensitivity after 4 hours and the type of device, across all strata.||||1.0
72557437|NCT00205777|144645422|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.238||||0.75|TWO_SIDED|95.0|0.332|4.616|||Regression, Logistic|||P value was calculated using logistic regression. Gail index was added to the model to account for baseline risk differences between participants.||4.616|0.332|0.75
72557438|NCT00205777|144645423|SUPERIORITY_OR_OTHER||Relative Risk|0.9|||||TWO_SIDED|95.0|0.38|2.15||||||Relative risk versus placebo was provided together with 95% CIs.||2.15|0.38|
72557439|NCT00205777|144645423|SUPERIORITY_OR_OTHER||Relative Risk|0.92|||||TWO_SIDED|95.0|0.39|2.21||||||Relative risk versus placebo was provided together with 95% CIs.||2.21|0.39|
72557440|NCT00205777|144645424|SUPERIORITY_OR_OTHER||Relative risk|1.01|||||TWO_SIDED|95.0|0.5|2.06||||||Relative risk versus placebo was provided together with 95% CIs.||2.06|0.5|
72557441|NCT00205777|144645425|SUPERIORITY_OR_OTHER|||||||0.57|TWO_SIDED||||||Log Rank|||||||0.57
72557442|NCT00205777|144645425|SUPERIORITY_OR_OTHER|||||||0.62|TWO_SIDED||||||Log Rank|||||||0.62
72557443|NCT00205777|144645425|SUPERIORITY_OR_OTHER|||||||0.72|TWO_SIDED||||||Log Rank|||||||0.72
72557444|NCT00205777|144645425|SUPERIORITY_OR_OTHER|||||||0.67|TWO_SIDED||||||Log Rank|||||||0.67
72434740|NCT04341298|144382895|SUPERIORITY|||||||0.021|||||||Mixed Models Analysis|Pain score difference after 2 hours modeled as a function of study arm, baseline pain score and headache medication use.||Null hypothesis is that 2 hour difference in pain score is equivalent between study arms, after adjusting for baseline pain score and headache medication use.||||0.021
72434741|NCT04341298|144382896|SUPERIORITY|||||||0.019|||||||Mixed Models Analysis|Pain score difference after 4 hours modeled as a function of study arm, baseline pain score and headache medication use.||Null hypothesis is that 4 hour difference in pain score is equivalent between study arms, after adjusting for baseline pain score and headache medication use.||||0.019
72557445|NCT00205777|144645425|SUPERIORITY_OR_OTHER|||||||0.89|TWO_SIDED||||||Log Rank|||||||0.89
72557446|NCT00205777|144645425|SUPERIORITY_OR_OTHER|||||||0.95|TWO_SIDED||||||Log Rank|||||||0.95
72557447|NCT00205777|144645426|SUPERIORITY_OR_OTHER|||||||0.29|TWO_SIDED||||||Log Rank|||||||0.29
72557448|NCT00205777|144645426|SUPERIORITY_OR_OTHER|||||||0.31|TWO_SIDED||||||Log Rank|||||||0.31
72557449|NCT00205777|144645426|SUPERIORITY_OR_OTHER|||||||0.94|TWO_SIDED||||||Log Rank|||||||0.94
72557450|NCT00205777|144645427|SUPERIORITY_OR_OTHER|||||||0.18|TWO_SIDED||||||Log Rank|||||||0.18
72557451|NCT00205777|144645431|SUPERIORITY_OR_OTHER|||||||0.46|TWO_SIDED||||||Log Rank|||Osteoporosis-Related: P value was calculated using Log-Rank test.||||0.46
72557452|NCT00205777|144645431|SUPERIORITY_OR_OTHER|||||||0.9|TWO_SIDED||||||Log Rank|||Osteoporosis-Related: P value was calculated using Log-Rank test.||||0.90
72557453|NCT00205777|144645431|SUPERIORITY_OR_OTHER|||||||0.93|TWO_SIDED||||||Log Rank|||Osteoporosis-Related: P value was calculated using Log-Rank test.||||0.93
72557454|NCT00205777|144645431|SUPERIORITY_OR_OTHER|||||||0.84|TWO_SIDED||||||Log Rank|||Osteoporosis-Related: P value was calculated using Log-Rank test.||||0.84
72557455|NCT00205777|144645431|SUPERIORITY_OR_OTHER|||||||0.39|TWO_SIDED||||||Log Rank|||Osteoporosis-Related: P value was calculated using Log-Rank test.||||0.39
72557456|NCT00205777|144645431|SUPERIORITY_OR_OTHER|||||||0.52|TWO_SIDED||||||Log Rank|||Osteoporosis-Related: P value was calculated using Log-Rank test.||||0.52
72557457|NCT00205777|144645431|SUPERIORITY_OR_OTHER|||||||0.28|TWO_SIDED||||||Log Rank|||Hip: P value was calculated using Log-Rank test.||||0.28
72557458|NCT00205777|144645431|SUPERIORITY_OR_OTHER|||||||0.31|TWO_SIDED||||||Log Rank|||Hip: P value was calculated using Log-Rank test.||||0.31
72557459|NCT00205777|144645431|SUPERIORITY_OR_OTHER|||||||0.17|TWO_SIDED||||||Log Rank|||Hip: P value was calculated using Log-Rank test.||||0.17
72557460|NCT00205777|144645431|SUPERIORITY_OR_OTHER|||||||0.72|TWO_SIDED||||||Log Rank|||Hip: P value was calculated using Log-Rank test.||||0.72
72557461|NCT00205777|144645431|SUPERIORITY_OR_OTHER|||||||0.97|TWO_SIDED||||||Log Rank|||Hip: P value was calculated using Log-Rank test.||||0.97
72557462|NCT00205777|144645431|SUPERIORITY_OR_OTHER|||||||0.76|TWO_SIDED||||||Log Rank|||Hip: P value was calculated using Log-Rank test.||||0.76
72557463|NCT00205777|144645431|SUPERIORITY_OR_OTHER|||||||0.29|TWO_SIDED||||||Log Rank|||Wrist: P value was calculated using Log-Rank test.||||0.29
72557464|NCT00205777|144645431|SUPERIORITY_OR_OTHER|||||||0.43|TWO_SIDED||||||Log Rank|||Wrist: P value was calculated using Log-Rank test.||||0.43
72557465|NCT00205777|144645431|SUPERIORITY_OR_OTHER|||||||0.59|TWO_SIDED||||||Log Rank|||Wrist: P value was calculated using Log-Rank test.||||0.59
72557466|NCT00205777|144645431|SUPERIORITY_OR_OTHER|||||||0.19|TWO_SIDED||||||Log Rank|||Wrist: P value was calculated using Log-Rank test.||||0.19
72557467|NCT00205777|144645431|SUPERIORITY_OR_OTHER|||||||0.8|TWO_SIDED||||||Log Rank|||Wrist: P value was calculated using Log-Rank test.||||0.80
72557468|NCT00205777|144645431|SUPERIORITY_OR_OTHER|||||||0.11|TWO_SIDED||||||Log Rank|||Wrist: P value was calculated using Log-Rank test.||||0.11
72557469|NCT00205777|144645432|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.012||||0.968|TWO_SIDED|95.0|0.79|1.296|||Log Rank|||Osteoporosis-Related: P value was calculated using Log-Rank test. Hazard ratio (Bazedoxifene 20 mg \[Core+SE I\] versus Placebo \[Core+SE I+SE II\]) based on a Cox proportional hazards regression model was presented along with 95% CIs.||1.296|0.790|0.968
72382531|NCT05419908|144273723|SUPERIORITY||LSMean Difference|-1.06||||0.081|TWO_SIDED|95.0|-2.25|0.13||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline weekly hfrdis as covariate.|ANCOVA|||Week 4: Sexuality||0.13|-2.25|0.081
72382532|NCT05419908|144273723|SUPERIORITY||LSMean Difference|-1.4||||0.05|TWO_SIDED|95.0|-2.8|0.0||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline weekly hfrdis as covariate.|ANCOVA|||Week 8: Sexuality||0.00|-2.80|0.050
72382533|NCT05419908|144273723|SUPERIORITY||LSMean Difference|-1.51||||0.026|TWO_SIDED|95.0|-2.84|-0.19||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline weekly hfrdis as covariate.|ANCOVA|||Week 12: Sexuality||-0.19|-2.84|0.026
72382534|NCT05419908|144273723|SUPERIORITY||LSMean Difference|-1.65|||<|0.001|TWO_SIDED|95.0|-2.51|-0.79||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline weekly hfrdis as covariate.|ANCOVA|||Week 4: Enjoyment of Life||-0.79|-2.51|<0.001
72382535|NCT05419908|144273723|SUPERIORITY||LSMean Difference|-2.07|||<|0.001|TWO_SIDED|95.0|-2.97|-1.18||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline weekly hfrdis as covariate.|ANCOVA|||Week 8: Enjoyment of Life||-1.18|-2.97|<0.001
72382536|NCT05419908|144273723|SUPERIORITY||LSMean Difference|-1.83|||<|0.001|TWO_SIDED|95.0|-2.88|-0.78||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline weekly hfrdis as covariate.|ANCOVA|||Week 12: Enjoyment of Life||-0.78|-2.88|<0.001
72494092|NCT01390909|144517164|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|658.0|||<|0.0001|TWO_SIDED|95.0|217.0|1131.0||Adjusted Cost Differences in Prescription Drug Costs, Non-AEDs|Ordinary Least Squares Regression|Covariates were gender, age, region, comorbidities, AEDs and non-AEDs known to increase seizure risk and baseline costs.||||1131|217|<0.0001
72494093|NCT01390909|144517164|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6040.0|||<|0.0001|TWO_SIDED|95.0|3442.0|8795.0||Adjusted Cost Differences in Hospitalizations, All Medical Costs|Ordinary Least Squares Regression|Covariates were gender, age, region, comorbidities, AEDs and non-AEDs known to increase seizure risk and baseline costs.||||8795|3442|<0.0001
72382537|NCT05419908|144273723|SUPERIORITY||LSMean difference|-1.92|||<|0.001|TWO_SIDED|95.0|-2.86|-0.97||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline weekly hfrdis as covariate.|ANCOVA|||Week4: Overall Quality of Life||-0.97|-2.86|<0.001
72382538|NCT05419908|144273723|SUPERIORITY||LSMean Difference|-2.51|||<|0.001|TWO_SIDED|95.0|-3.41|-1.61||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline weekly hfrdis as covariate.|ANCOVA|||Week 8: Overall Quality of Life||-1.61|-3.41|<0.001
72382539|NCT05419908|144273723|SUPERIORITY||LSMean Difference|-2.36|||<|0.001|TWO_SIDED|95.0|-3.31|-1.41||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline weekly hfrdis as covariate.|ANCOVA|||Week 12: Overall Quality of Life||-1.41|-3.31|<0.001
72382540|NCT05419908|144273723|SUPERIORITY||LSMean Difference|-1.98|||<|0.001|TWO_SIDED|95.0|-2.73|-1.23||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline weekly hfrdis as covariate.|ANCOVA|||Week 4: Overall Mean Score||-1.23|-2.73|<0.001
72382541|NCT05419908|144273723|SUPERIORITY||LSMean Difference|-2.21|||<|0.001|TWO_SIDED|95.0|-3.02|-1.4||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline weekly hfrdis as covariate.|ANCOVA|||Week 8: Overall Mean Score||-1.40|-3.02|<0.001
72494094|NCT01390909|144517164|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|268.0||||0.002|TWO_SIDED|95.0|81.0|425.0||Adjusted Cost Differences in Emergency Department Visits, All Medical Costs|Ordinary Least Squares Regression|Covariates were gender, age, region, comorbidities, AEDs and non-AEDs known to increase seizure risk and baseline costs.||||425|81|0.0020
72494095|NCT01390909|144517164|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-40.0||||0.967|TWO_SIDED|95.0|-991.0|944.0||Adjusted Cost Differences in Outpatient Services, All Medical Costs|Ordinary Least Squares Regression|Covariates were gender, age, region, comorbidities, AEDs and non-AEDs known to increase seizure risk and baseline costs.||||944|-991|0.9670
72494096|NCT01390909|144517164|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|97.0||||0.2563|TWO_SIDED|95.0|-77.0|302.0||Adjusted Cost Differences in Neurologist Visits, All Medical Costs|Ordinary Least Squares Regression|Covariates were gender, age, region, comorbidities, AEDs and non-AEDs known to increase seizure risk and baseline costs.||||302|-77|0.2563
72494097|NCT01390909|144517164|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|328.0||||0.01|TWO_SIDED|95.0|90.0|588.0||Adjusted Cost Differences in Other Healthcare Services, All Medical Costs|Ordinary Least Squares Regression|Covariates were gender, age, region, comorbidities, AEDs and non-AEDs known to increase seizure risk and baseline costs.||||588|90|0.0100
72382542|NCT05419908|144273723|SUPERIORITY||LSMean Difference|-1.98|||<|0.001|TWO_SIDED|95.0|-2.83|-1.13||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline weekly hfrdis as covariate.|ANCOVA|||Week 12: Overall Mean Score||-1.13|-2.83|<0.001
72382543|NCT05419908|144273724|SUPERIORITY||LSMean Difference|1.375|||<|0.001|TWO_SIDED|95.0|0.651|2.1||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline LSEQ as covariate.|ANCOVA|||Week 4: Getting to Sleep||2.100|0.651|<0.001
72382544|NCT05419908|144273724|SUPERIORITY||LSMean Difference|1.166|||<|0.001|TWO_SIDED|95.0|0.505|1.827||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline LSEQ as covariate.|ANCOVA|||Week 8: Getting to Sleep||1.827|0.505|<0.001
72494098|NCT01390909|144517164|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4984.0|||<|0.0001|TWO_SIDED|95.0|3168.0|7335.0||Adjusted Cost Differences in Hospitalizations, Epilepsy-Related|Ordinary Least Squares Regression|Covariates were gender, age, region, comorbidities, AEDs and non-AEDs known to increase seizure risk and baseline costs.||||7335|3168|<0.0001
72494099|NCT01390909|144517164|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|112.0|||<|0.0001|TWO_SIDED|95.0|70.0|166.0||Adjusted Cost Differences in Emergency Department Visits, Epilepsy-Related|Ordinary Least Squares Regression|Covariates were gender, age, region, comorbidities, AEDs and non-AEDs known to increase seizure risk and baseline costs.||||166|70|<0.0001
72382545|NCT05419908|144273724|SUPERIORITY||LSMean Difference|0.895||||0.014|TWO_SIDED|95.0|0.19|1.599||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline LSEQ as covariate.|ANCOVA|||Week 12: Getting to Sleep||1.599|0.190|0.014
72382546|NCT05419908|144273724|SUPERIORITY||LSMean Difference|2.423|||<|0.001|TWO_SIDED|95.0|1.308|3.539||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline LSEQ as covariate.|ANCOVA|||Week 4: Quality of Sleep||3.539|1.308|<0.001
72382547|NCT05419908|144273724|SUPERIORITY||LSMean Difference|2.291|||<|0.001|TWO_SIDED|95.0|1.31|3.251||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline LSEQ as covariate.|ANCOVA|||Week 8: Quality of Sleep||3.251|1.31|<0.001
72382548|NCT05419908|144273724|SUPERIORITY||LSMean Difference|2.433|||<|0.001|TWO_SIDED|95.0|1.334|3.532||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline LSEQ as covariate.|ANCOVA|||Week 12: Quality of Sleep||3.532|1.334|<0.001
72382549|NCT05419908|144273724|SUPERIORITY||LSMean Difference|0.877||||0.059|TWO_SIDED|95.0|-0.034|1.789||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline LSEQ as covariate.|ANCOVA|||Week 4: Awake Following Sleep||1.789|-0.034|0.059
72382550|NCT05419908|144273724|SUPERIORITY||LSMean Difference|1.457||||0.001|TWO_SIDED|95.0|0.579|2.335||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline LSEQ as covariate.|ANCOVA|||Week 8: Awake Following Sleep||2.335|0.579|0.001
72382551|NCT05419908|144273724|SUPERIORITY||LSMean Difference|1.113||||0.031|TWO_SIDED|95.0|0.107|2.12||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline LSEQ as covariate.|ANCOVA|||Week 12: Awake Following Sleep||2.120|0.107|0.031
72382552|NCT05419908|144273724|SUPERIORITY||LSMean Difference|1.203||||0.008|TWO_SIDED|95.0|0.317|2.088||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline LSEQ as covariate.|ANCOVA|||Week 4: Behaviour Following Wakening||2.088|0.317|0.008
72382553|NCT05419908|144273724|SUPERIORITY||LSMean Difference|1.597||||0.001|TWO_SIDED|95.0|0.639|2.556||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline LSEQ as covariate.|ANCOVA|||Week 8: Behaviour Following Wakening||2.556|0.639|0.001
72382554|NCT05419908|144273724|SUPERIORITY||LSMean Difference|0.842||||0.084|TWO_SIDED|95.0|-0.116|1.8||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline LSEQ as covariate.|ANCOVA|||Week 12: Behaviour Following Sleep||1.800|-0.116|0.084
72382555|NCT05419908|144273725|SUPERIORITY||LSMean Difference|0.0||||0.881|TWO_SIDED|95.0|-0.3|0.3||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline GCS as covariate.|ANCOVA|||Week 4: Loss of Interest in Sex||0.3|-0.3|0.881
72382556|NCT05419908|144273725|SUPERIORITY||LSMean Difference|-0.2||||0.383|TWO_SIDED|95.0|-0.6|0.2||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline GCS as covariate.|ANCOVA|||Week 8: Loss of Interest in Sex||0.2|-0.6|0.383
72382557|NCT05419908|144273725|SUPERIORITY||LSMean Difference|-0.2||||0.301|TWO_SIDED|95.0|-0.6|0.2||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline GCS as covariate.|ANCOVA|||Week 12: Loss of Interest in Sex||0.2|-0.6|0.301
72382558|NCT05419908|144273725|SUPERIORITY||LSMean Difference|-2.5||||0.02|TWO_SIDED|95.0|-4.5|-0.4||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline GCS as covariate.|ANCOVA|||Week 4: Psychological||-0.4|-4.5|0.020
72382559|NCT05419908|144273725|SUPERIORITY||LSMean Difference|-3.3||||0.003|TWO_SIDED|95.0|-5.4|-1.2||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline GCS as covariate.|ANCOVA|||Week 8: Psychological||-1.2|-5.4|0.003
72382560|NCT05419908|144273725|SUPERIORITY||LSMean Difference|-3.1||||0.005|TWO_SIDED|95.0|-5.2|-1.0||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline GCS as covariate.|ANCOVA|||Week 12: Psychological||-1.0|-5.2|0.005
72382561|NCT05419908|144273725|SUPERIORITY||LSMean Difference|-0.2||||0.732|TWO_SIDED|95.0|-1.2|0.9||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline GCS as covariate.|ANCOVA|||Week 4: Physical||0.9|-1.2|0.732
72382562|NCT05419908|144273725|SUPERIORITY||LSMean Difference|-0.7||||0.282|TWO_SIDED|95.0|-1.9|0.6||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline GCS as covariate.|ANCOVA|||Week 8: Physical||0.6|-1.9|0.282
72382563|NCT05419908|144273725|SUPERIORITY||LSMean Difference|-0.6||||0.254|TWO_SIDED|95.0|-1.7|0.5||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline GCS as covariate.|ANCOVA|||Week 12: Physical||0.5|-1.7|0.254
72382564|NCT05419908|144273725|SUPERIORITY||LSMean Difference|-2.0|||<|0.001|TWO_SIDED|95.0|-2.7|-1.4||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline GCS as covariate.|ANCOVA|||Week 4: Vasomotor||-1.4|-2.7|<0.001
72382565|NCT05419908|144273725|SUPERIORITY||LSMean Difference|-1.8|||<|0.001|TWO_SIDED|95.0|-2.4|-1.1||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline GCS as covariate.|ANCOVA|||Week 8: Vasomotor||-1.1|-2.4|<0.001
72382566|NCT05419908|144273725|SUPERIORITY||LSMean Difference|-2.0|||<|0.001|TWO_SIDED|95.0|-2.6|-1.3||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline GCS as covariate.|ANCOVA|||Week 12: Vasomotor||-1.3|-2.6|<0.001
72382567|NCT05419908|144273725|SUPERIORITY||LSMean Difference|-4.6||||0.013|TWO_SIDED|95.0|-8.2|-1.0||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline GCS as covariate.|ANCOVA|||Week 4: Total Symptom Score||-1.0|-8.2|0.013
72382568|NCT05419908|144273725|SUPERIORITY||LSMean Difference|-6.9|||<|0.001|TWO_SIDED|95.0|-10.7|-3.1||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline GCS as covariate.|ANCOVA|||Week 8: Total Symptom Score||-3.1|-10.7|<0.001
72382569|NCT05419908|144273725|SUPERIORITY||LSMean Difference|-6.3|||<|0.001|TWO_SIDED|95.0|-9.9|-2.8||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline GCS as covariate.|ANCOVA|||Week 12: Total Symptom Score||-2.8|-9.9|<0.001
72382570|NCT05419908|144273726|SUPERIORITY||LSMean Difference|-1.7|||<|0.001|TWO_SIDED|95.0|-2.7|-0.8||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline SDS as covariate.|ANCOVA|||Week 4: Work/School||-0.8|-2.7|<0.001
72382571|NCT05419908|144273726|SUPERIORITY||LSMean Difference|-2.0|||<|0.001|TWO_SIDED|95.0|-2.8|-1.3||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline SDS as covariate.|ANCOVA|||Week 8: Work/School||-1.3|-2.8|<0.001
72382572|NCT05419908|144273726|SUPERIORITY||LSMean Difference|-1.6|||<|0.001|TWO_SIDED|95.0|-2.5|-0.8||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline SDS as covariate.|ANCOVA|||Week 12: Work/School||-0.8|-2.5|<0.001
72382573|NCT05419908|144273726|SUPERIORITY||LSMean Difference|-1.4|||<|0.001|TWO_SIDED|95.0|-2.2|-0.6||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline SDS as covariate.|ANCOVA|||Week 4: Social Life||-0.6|-2.2|<0.001
72382574|NCT05419908|144273726|SUPERIORITY||LSMean Difference|-1.9|||<|0.001|TWO_SIDED|95.0|-2.7|-1.1||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline SDS as covariate.|ANCOVA|||Week 8: Social Life||-1.1|-2.7|<0.001
72382575|NCT05419908|144273726|SUPERIORITY||LSMean Difference|-1.6|||<|0.001|TWO_SIDED|95.0|-2.4|-0.7||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline SDS as covariate.|ANCOVA|||Week 12: Social Life||-0.7|-2.4|<0.001
72382576|NCT05419908|144273726|SUPERIORITY||LSMean Difference|-1.3||||0.005|TWO_SIDED|95.0|-2.2|-0.4||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline SDS as covariate.|ANCOVA|||Week 4: Family Life/Home Responsibilities||-0.4|-2.2|0.005
72382577|NCT05419908|144273726|SUPERIORITY||LSMean Difference|-1.7|||<|0.001|TWO_SIDED|95.0|-2.5|-0.9||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline SDS as covariate.|ANCOVA|||Week 8: Family Life/Home Responsibilities||-0.9|-2.5|<0.001
72382578|NCT05419908|144273726|SUPERIORITY||LSMean Difference|-1.6|||<|0.001|TWO_SIDED|95.0|-2.4|-0.7||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline SDS as covariate.|ANCOVA|||Week 12: Family Life/Home Responsibilities||-0.7|-2.4|<0.001
72382579|NCT05419908|144273726|SUPERIORITY||LSMean Difference|-4.4|||<|0.001|TWO_SIDED|95.0|-6.9|-2.0||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline SDS as covariate.|ANCOVA|||Week 4: Global Functional Impairment||-2.0|-6.9|<0.001
72382580|NCT05419908|144273726|SUPERIORITY||LSMean Difference|-5.8|||<|0.001|TWO_SIDED|95.0|-8.0|-3.6||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline SDS as covariate.|ANCOVA|||Week 8: Global Functional Impairment||-3.6|-8.0|<0.001
72382581|NCT05419908|144273726|SUPERIORITY||LSMean Difference|-5.3|||<|0.001|TWO_SIDED|95.0|-7.8|-2.8||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline SDS as covariate.|ANCOVA|||Week 12: Global Functional Impairment||-2.8|-7.8|<0.001
72382582|NCT05419908|144273727|SUPERIORITY||LSMean difference|0.0||||0.936|TWO_SIDED|95.0|-0.5|0.6||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline SDS as covariate.|ANCOVA|||Week 4: Days Lost||0.6|-0.5|0.936
72382583|NCT05419908|144273727|SUPERIORITY||LSMean difference|0.0||||0.884|TWO_SIDED|95.0|-0.1|0.1||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline SDS as covariate.|ANCOVA|||Week 8: Days Lost||0.1|-0.1|0.884
72382584|NCT05419908|144273727|SUPERIORITY||LSMean difference|-0.2||||0.124|TWO_SIDED|95.0|-0.4|0.1||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline SDS as covariate.|ANCOVA|||Week 12: Days Lost||0.1|-0.4|0.124
72382585|NCT05419908|144273727|SUPERIORITY||LSMean difference|-0.9||||0.052|TWO_SIDED|95.0|-1.8|0.0||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline SDS as covariate.|ANCOVA|||Week 4: Days Unproductive||0.0|-1.8|0.052
72434742|NCT04341298|144382897|SUPERIORITY|Null hypothesis is that proportion of headaches with light sensitivity experienced after 2 hours is equivalent between study arms, after adjusting for baseline pain score and headache medication use.||||||0.028|||||||Mixed Models Analysis|Proportion of headaches with light sensitivity after 2 hours modeled as a function of study arm, baseline pain score and headache medication use.||||||0.028
72494100|NCT01390909|144517164|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|236.0||||0.01|TWO_SIDED|95.0|70.0|403.0||Adjusted Cost Differences in Outpatient Services, Epilepsy-Related|Ordinary Least Squares Regression|Covariates were gender, age, region, comorbidities, AEDs and non-AEDs known to increase seizure risk and baseline costs.||||403|70|0.01
72382586|NCT05419908|144273727|SUPERIORITY||LSMean difference|-0.9||||0.06||95.0|-1.7|0.0||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline SDS as covariate.|ANCOVA|||Week 8: Days Unproductive||0.0|-1.7|0.060
72382587|NCT05419908|144273727|SUPERIORITY||LSMean difference|-0.8||||0.049|TWO_SIDED|95.0|-1.7|0.0||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline SDS as covariate.|ANCOVA|||Week 12: Days Unproductive||0.0|-1.7|0.049
72382588|NCT02360995|144273753|SUPERIORITY_OR_OTHER|||||||0.652|TWO_SIDED||||||ANOVA|||The null hypothesis states that there is no difference between groups.||||0.652
72382589|NCT02360995|144273754|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||<0.001
72382590|NCT02360995|144273755|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||<0.001
72382591|NCT02360995|144273756|SUPERIORITY_OR_OTHER|||||||0.533|TWO_SIDED||||||ANOVA|||The null hypothesis states that there is no difference between groups.||||0.533
72382592|NCT02360995|144273757|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||<0.001
72557470|NCT00205777|144645432|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.846||||0.211|TWO_SIDED|95.0|0.652|1.097|||Log Rank|||Osteoporosis-Related: P value was calculated using Log-Rank test. Hazard ratio (Bazedoxifene 40/20 mg \[SE I\] versus Placebo \[Core+SE I+SE II\]) based on a Cox proportional hazards regression model was presented along with 95% CIs.||1.097|0.652|0.211
72434743|NCT04341298|144382898|SUPERIORITY|||||||0.46|||||||Mixed Models Analysis|Proportion of headaches with light sensitivity after 4 hours modeled as a function of study arm, baseline pain score and headache medication use.||Null hypothesis is that proportion of headaches with light sensitivity experienced after 4 hours is equivalent between study arms, after adjusting for baseline pain score and headache medication use.||||0.46
72434744|NCT00646451|144382975|SUPERIORITY_OR_OTHER_LEGACY|||||||0.162|||||||ANOVA|||"Outcome on study completers was assessed via ANOVA models using a 2 × 2 Latin-square crossover design including sequence, period, and treatment effects. A significant carryover effect was excluded. Analyses were performed using Stata IC version 10.0 for Windows.~Unfortunately the small sample size of our study limits the possibility of a meaningful post-hoc analysis targeted to these variables."|The Quest rates patient perception of health status as influenced by tremor across 5 domains, physical, psychosocial, communication, hobbies/leisure, and work/finance. HAM-A rates severity of anxiety symptomatology across 14 parameters. Scores of 14-17 correspond to mild anxiety, scores of 18-24 is moderate anxiety and 25-30 severe anxiety. HD-16 rates insomnia-related QoL across 5 domains: physical symptoms, energy \& motivation, concentration, interpersonal relations and psychological symptoms. These scales were scored per published guidelines.|||0.162
72434745|NCT03720990|144382976|SUPERIORITY|||||||0.011|||||||t-test, 2 sided|||||||0.011
72434746|NCT01249092|144382977|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-57.3|STANDARD_DEVIATION|62.1||0.001|TWO_SIDED|95.0|-88.2|-26.4||This study tested the hypothesis that treatment with pentoxifylline would result in a statistically significant change from baseline in the level of alkaline phosphatase.|Paired t-test|||A p-value \< 0.05 was considered statistically significant and all analyses were carried out using SAS version 9.2 (The SAS Institute, Cary, NC). Matched pairs t-test was used to compare the change in alkaline phosphatase from baseline. The efficacy of therapy was measured based on improvement in AP levels after therapy with PTX. AP levels at end of the study were compared with values at baseline by matched pairs t-test.||-26.4|-88.2|0.001
72434747|NCT01249092|144382978|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.69|STANDARD_ERROR_OF_MEAN|8.66||0.5|TWO_SIDED|95.0|-24.14|8.68||Hypothesis tested if TIMP-1 levels after therapy with pentoxifylline changed significantly from baseline from baseline.|Paired t-test.|||Change from baseline in TIMP-1 levels was assessed by paired-t test. Distribution the variable values was assessed using normal probability plots. Matched pairs t-test was used to compare the change from baseline.||8.68|-24.14|0.5
72434748|NCT01710514|144383021|NON_INFERIORITY_OR_EQUIVALENCE|The null hypothesis (H0) was tested against the alternative (Ha) by constructing two-sided 95%CI for the difference. The non-inferiority limit for the difference was pre-specified to -10.0% (absolute). If the lower limit of the two-sided 95%CI was greater than the non-inferiority limit (-10.0%) for both the FAS and per protocol set, the null hypothesis was to be rejected. In that case it would be claimed that the rate observed in this trial was non-inferior to the rate observed in the CS08 trial|Difference of % to historical control|-0.9|||||TWO_SIDED|95.0|-3.6|1.8||||||To verify sufficient supplementation of luteal hormone, the proportion of subjects with blood progesterone concentration ≥ 10 ng/mL on Day 5 was compared to the result from a historical control, trial CS08 (NCT number: 00884221). The corresponding proportion of subjects in trial CS08 was 99.8% (95%CI: 99.1;100.0, 631/632 subjects). The non-inferiority hypothesis tested for this primary endpoint was: H0: P(000072)-P(CS08) ≤ -10.0% against the alternative Ha: P(000072)-P(CS08) \> -10.0%.||1.8|-3.6|
72434749|NCT03383887|144383029|SUPERIORITY||Median Difference (Final Values)|2.7||||0.56|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.56
72434750|NCT03383887|144383030|SUPERIORITY|||||||0.027|||||||Wilcoxon (Mann-Whitney)|||||||0.027
72434751|NCT00434018|144383035|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED||||||ANOVA|||||||0.001
72434752|NCT01335932|144383051|OTHER|||||||0.0001|||||||Fisher Exact|||||||.0001
72434753|NCT01335932|144383052|OTHER|||||||0.31|||||||t-test, 2 sided|||||||0.31
72434754|NCT01335932|144383058|OTHER|||||||0.006|||||||Fisher Exact|||||||0.006
72434755|NCT01335932|144383059|OTHER|||||||0.14|||||||Fisher Exact|||||||0.14
72434756|NCT01335932|144383060|OTHER|||||||0.1|||||||Fisher Exact|||||||0.10
72434757|NCT01335932|144383061|OTHER|||||||0.002|||||||t-test, 2 sided|||||||0.002
72434758|NCT01335932|144383062|OTHER|||||||0.03|||||||t-test, 2 sided|||||||0.03
72434759|NCT01335932|144383063|OTHER||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
72434760|NCT01335932|144383064|OTHER|||||||0.73|||||||t-test, 2 sided|||||||0.73
72434761|NCT01335932|144383065|OTHER|||||||0.33|||||||t-test, 2 sided|||||||0.33
72434762|NCT01335932|144383066|OTHER|||||||0.31|||||||t-test, 2 sided|||||||0.31
72434763|NCT01335932|144383067|OTHER|||||||0.96|||||||t-test, 2 sided|||||||0.96
72434764|NCT01335932|144383068|OTHER|||||||0.63|||||||t-test, 2 sided|||||||0.63
72434765|NCT01335932|144383069|OTHER|||||||0.51|||||||t-test, 2 sided|||||||0.51
72434766|NCT01335932|144383070|OTHER|||||||0.12|||||||t-test, 2 sided|||||||0.12
72434767|NCT01335932|144383071|OTHER|||||||0.13|||||||t-test, 2 sided|||||||0.13
72434768|NCT01335932|144383072|OTHER|||||||0.008|||||||t-test, 2 sided|||||||0.008
72434769|NCT01335932|144383073|OTHER|||||||0.64|||||||t-test, 2 sided|||||||0.64
72434770|NCT01335932|144383074|OTHER|||||||0.24|||||||t-test, 2 sided|||||||0.24
72434771|NCT01335932|144383075|OTHER|||||||0.76|||||||t-test, 2 sided|||||||0.76
72434772|NCT01335932|144383076|OTHER|||||||0.45|||||||t-test, 2 sided|||||||0.45
72434773|NCT01335932|144383077|OTHER|||||||0.92|||||||t-test, 2 sided|||||||0.92
72434774|NCT01335932|144383078|OTHER|||||||0.94|||||||t-test, 2 sided|||||||0.94
72434775|NCT01335932|144383079|OTHER|||||||0.37|||||||t-test, 2 sided|||||||0.37
72434776|NCT01335932|144383080|OTHER|||||||0.8|||||||t-test, 2 sided|||||||0.80
72434777|NCT01335932|144383081|OTHER|||||||0.93|||||||t-test, 2 sided|||||||0.93
72434778|NCT01335932|144383082|OTHER|||||||0.93|||||||t-test, 2 sided|||||||0.93
72434779|NCT01335932|144383083|OTHER|||||||0.45|||||||t-test, 2 sided|||||||0.45
72618690|NCT01026038|144768108|SUPERIORITY_OR_OTHER||GMT ratio|0.8|||||TWO_SIDED|95.0|0.13|5.14||||||Serotype 14: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||5.14|0.13|
72434780|NCT00952718|144383117|SUPERIORITY|||||||0.005||||||p-value for MIP was adjusted by linear regression model.|Regression, Linear|||||||0.005
72434781|NCT00952718|144383117|SUPERIORITY|||||||0.038||||||adjusted p for MEP by linear regression|Regression, Linear|||||||0.038
72434782|NCT00952718|144383118|SUPERIORITY|||||||0.063|||||||Regression, Linear|||||||0.063
72382593|NCT02360995|144273758|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||<0.001
72382594|NCT02611960|144273759|SUPERIORITY||Hazard Ratio (HR)|0.9||||0.2262|TWO_SIDED|95.0|0.67|1.19||One-sided p-value based on log-rank test stratified by presence of liver metastasis.|Stratified Log-Rank Test|||Comparison based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by presence of liver metastasis.||1.19|0.67|0.2262
72382595|NCT02611960|144273760|SUPERIORITY||Hazard Ratio (HR)|1.28||||0.9419|TWO_SIDED|95.0|0.94|1.75||One-sided p-value based on log-rank test stratified by presence of liver metastasis.|Stratified Log-Rank Test|||Comparison based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by presence of liver metastasis.||1.75|0.94|0.9419
72382596|NCT02611960|144273761|SUPERIORITY||Difference in Percentage|-1.9||||0.63479|TWO_SIDED|95.0|-12.7|8.9||One-sided p-value for testing. H0: difference in percentage = 0 versus H1: difference in percentage \> 0.|Stratified Miettinen and Nurminen Method|||Comparison based on Miettinen \& Nurminen method stratified by presence of liver metastasis.||8.9|-12.7|0.63479
72382597|NCT04622735|144273803|SUPERIORITY|||||||0.0031|||||||Mixed Models Analysis|||||||0.0031
72382598|NCT04622735|144273803|SUPERIORITY|||||||0.6787|||||||Mixed Models Analysis|||||||0.6787
72382599|NCT02476422|144273836|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.2||||0.211|TWO_SIDED|95.0|-1.8|8.3|||ANCOVA|||||8.3|-1.8|0.211
72382600|NCT00857415|144273849|SUPERIORITY_OR_OTHER||Correlation coefficient|0.78|STANDARD_ERROR_OF_MEAN|0.194|<|0.0001|TWO_SIDED|95.0|0.58|0.89||A one-sided test (rho \> 0) was performed with a significance level of alpha=0.05 to assess a significant correlation.|Spearman's Rank Correlation test||Asymptotic standard error and 95 percent CI used Fisher z-transformation.|Spearman's Rank Order Correlation of the median semiquantitative read (three readers) and the quantitative IHC measurement of cortical amyloid plaque density averaged across six brain regions.||0.89|0.58|<0.0001
72382601|NCT00857415|144273850|SUPERIORITY_OR_OTHER||Specificity|100.0|||||TWO_SIDED|95.0|91.0|100.0|||||95% CI calculated by Wilson score method|Proportion of subjects who had a negative scan based on majority of 3 blinded readers||100|91|
72382602|NCT01130103|144273852|SUPERIORITY_OR_OTHER||incident rate ratio|0.5||||0.01|TWO_SIDED|95.0|0.3|0.85|||Mixed Models Analysis|||caps total score at weeks 5 and 10||.85|.30|.01
72434783|NCT00952718|144383119|SUPERIORITY|||||||0.269|||||||Regression, Linear|||||||0.269
72434784|NCT01235949|144383120|NON_INFERIORITY|Criterion for evaluation of non-inferiority: The upper limit (UL) of the 2-sided 98.25% confidence interval (98.25% CI) (adjusted 1-sided alpha = 0.875%) of the difference between groups (NIBU minus IIBU), in terms of percentage of subjects with pneumococcal antibody concentrations ≥ 0.2 µg/mL, was lower than (\<) 10% for at least 7 out of the 10 pneumococcal serotypes.|Difference in percentages|-0.62|||||TWO_SIDED|98.25|-4.52|3.17||||||At one month after primary immunization, the difference between groups (NIBU minus IIBU), in terms of percentage of subjects with pneumococcal antibody concentrations ≥ 0.2 µg/mL were calculated for anti-pneumococccal serotype 1.||3.17|-4.52|
72434785|NCT01235949|144383120|NON_INFERIORITY|Criterion for evaluation of non-inferiority: the upper limit (UL) of the 2-sided 98.25% confidence interval (98.25% CI) (adjusted 1-sided alpha = 0.875%) of the difference between groups (NIBU minus IIBU), in terms of percentage of subjects with pneumococcal antibody concentrations ≥ 0.2 µg/mL, was lower than (\<) 10% for at least 7 out of the 10 pneumococcal serotypes.|Difference in percentages|0.06|||||TWO_SIDED|98.25|-3.94|4.38||||||At one month after primary immunization, the difference between groups (NIBU minus IIBU), in terms of percentage of subjects with pneumococcal antibody concentrations ≥ 0.2 µg/mL were calculated for anti-pneumococcal serotype 4.||4.38|-3.94|
72434786|NCT01235949|144383120|NON_INFERIORITY|Criterion for evaluation of non-inferiority: The upper limit (UL) of the 2-sided 98.25% confidence interval (98.25% CI) (adjusted 1-sided alpha = 0.875%) of the difference between groups (NIBU minus IIBU), in terms of percentage of subjects with pneumococcal antibody concentrations ≥ 0.2 µg/mL, was lower than (\<) 10% for at least 7 out of the 10 pneumococcal serotypes.|Difference in percentages|-0.64|||||TWO_SIDED|98.25|-4.63|3.19||||||At one month after primary immunization, the difference between groups (NIBU minus IIBU), in terms of percentage of subjects with pneumococcal antibody concentrations ≥ 0.2 µg/mL were calculated for anti-pneumococccal serotype 5.||3.19|-4.63|
72618691|NCT01026038|144768108|SUPERIORITY_OR_OTHER||GMT ratio|0.2|||||TWO_SIDED|95.0|0.04|0.8||||||Serotype 18C: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||0.80|0.04|
72382603|NCT01130103|144273852|SUPERIORITY_OR_OTHER||incident rate ratio|0.56|||<|0.001|TWO_SIDED|95.0|0.43|0.74|||Mixed Models Analysis|||rate of change in CAPS total from week 5 to week 10||.74|.43|<.001
72382604|NCT01130103|144273856|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|12.6||||0.03|TWO_SIDED|95.0|1.23|129.0|||Mixed Models Analysis|||treatment group effect: remission rate at weeks 5 and 10||129|1.23|.03
72382605|NCT01130103|144273856|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|20.8||||0.007|TWO_SIDED|95.0|2.44|176.0|||Mixed Models Analysis|||rate of change over time in remission rate from week 5 to 10||176|2.44|0.007
72382606|NCT02992132|144273870|SUPERIORITY||Difference in LSM|5.1|STANDARD_ERROR_OF_MEAN|5.0|||TWO_SIDED|95.0|-4.8|15.0||||||Mixed-effect model repeated measures (MMRM), with the dependent variable being the change from Baseline in CMAI total score.||15.0|-4.8|
72382607|NCT02992132|144273870|SUPERIORITY||Difference in LSM|1.0|STANDARD_ERROR_OF_MEAN|4.8|||TWO_SIDED|95.0|-8.5|10.5||||||Mixed-effect model repeated measures (MMRM), with the dependent variable being the change from Baseline in CMAI total score.||10.5|-8.5|
72382608|NCT00620464|144273896|SUPERIORITY_OR_OTHER_LEGACY|||||||0.05||90.0||||Applies to all parameters.|Bioequivalence Testing|||||||0.05
72382609|NCT00620464|144273897|SUPERIORITY_OR_OTHER_LEGACY||||||<=|0.05||95.0|||||Bioequivalence Testing|||||||<=0.05
72618692|NCT01026038|144768108|SUPERIORITY_OR_OTHER||GMT ratio|0.5|||||TWO_SIDED|95.0|0.12|2.03||||||Serotype 18C: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||2.03|0.12|
72382610|NCT03911154|144273910|OTHER|We used linear mixed effect models (in SAS version 9.4, SAS Institute, Cary, NC) with random subject intercept to account for the clustered nature of the data. The model included factors for stimulus modality (4 levels), sleep restriction night (4 levels), and their interaction.|Mean Difference (Net)|0.329|STANDARD_ERROR_OF_MEAN|0.353||0.36|TWO_SIDED|95.0|-0.403|1.06|||Mixed Models Analysis|||Number of lapses of attention were averaged across assessments within each day and the statistical analysis adjusted for baseline.||1.060|-0.403|0.36
72382611|NCT03911154|144273910|OTHER|Linear mixed effects model with a random subject intercept.|Mean Difference (Net)|-0.307|STANDARD_ERROR_OF_MEAN|0.441||0.49|TWO_SIDED|95.0|-1.222|0.608|||Mixed Models Analysis|||Number of lapses of attention upon emergent awakening||0.608|-1.222|0.49
72382612|NCT03911154|144273911|OTHER|Linear mixed effects model with a random subject intercept.|Mean Difference (Net)|0.455|STANDARD_ERROR_OF_MEAN|2.797||0.87|TWO_SIDED|95.0|-5.4|6.31|||Mixed Models Analysis|||||6.310|-5.400|0.87
72382613|NCT03911154|144273912|OTHER|Linear mixed effects model with a random subject intercept.|Mean Difference (Net)|-0.112|STANDARD_ERROR_OF_MEAN|0.798||0.89|TWO_SIDED|95.0|-1.767|1.543|||Mixed Models Analysis|||Number correct on the DSST was averaged across DSST administrations within each day and was adjusted for baseline performance.||1.543|-1.767|0.89
72382614|NCT03911154|144273913|OTHER|Linear mixed effects model with a random subject intercept.|Mean Difference (Net)|-0.121|STANDARD_ERROR_OF_MEAN|0.381||0.76|TWO_SIDED|95.0|-0.919|0.678|||Mixed Models Analysis|||Number correct on the DST was averaged across DST administrations within each day and adjusted for baseline.||0.678|-0.919|0.76
72382615|NCT03911154|144273914|OTHER|Linear mixed effects model with a random subject intercept.|Mean Difference (Net)|0.085|STANDARD_ERROR_OF_MEAN|0.179||0.64|TWO_SIDED|95.0|-0.286|0.456|||Mixed Models Analysis|||The mean weighted score on the ROBoT was adjusted for baseline.||0.456|-0.286|0.64
72382616|NCT02035475|144273928|SUPERIORITY_OR_OTHER|||||||0.412|||||||McNemar|||The null hypothesis is that there is no difference in the incidence of detected lymphoceles whether the EndoWrist 1 Vessel Sealer or the Fenestrated Maryland BiPolar Instrument were used.||||0.412
72434787|NCT01235949|144383120|NON_INFERIORITY|Criterion for evaluation of non-inferiority: The upper limit (UL) of the 2-sided 98.25% confidence interval (98.25% CI) (adjusted 1-sided alpha = 0.875%) of the difference between groups (NIBU minus IIBU), in terms of percentage of subjects with pneumococcal antibody concentrations ≥ 0.2 µg/mL, was lower than (\<) 10% for at least 7 out of the 10 pneumococcal serotypes.|Difference in percentages|0.69|||||TWO_SIDED|98.25|-9.4|10.99||||||At one month after primary immunization, the difference between groups (NIBU minus IIBU), in terms of percentage of subjects with pneumococcal antibody concentrations ≥ 0.2 µg/mL were calculated for anti-pneumococccal serotype 6B.||10.99|-9.4|
72434788|NCT01235949|144383120|NON_INFERIORITY|Criterion for evaluation of non-inferiority: The upper limit (UL) of the 2-sided 98.25% confidence interval (98.25% CI) (adjusted 1-sided alpha = 0.875%) of the difference between groups (NIBU minus IIBU), in terms of percentage of subjects with pneumococcal antibody concentrations ≥ 0.2 µg/mL, was lower than (\<) 10% for at least 7 out of the 10 pneumococcal serotypes.|Difference in percentages|0.65|||||TWO_SIDED|98.25|-2.7|4.71||||||At one month after primary immunization, the difference between groups (NIBU minus IIBU), in terms of percentage of subjects with pneumococcal antibody concentrations ≥ 0.2 µg/mL were calculated for anti-pneumococccal serotype 7F.||4.71|-2.7|
72434789|NCT01235949|144383120|NON_INFERIORITY|Criterion for evaluation of non-inferiority: The upper limit (UL) of the 2-sided 98.25% confidence interval (98.25% CI) (adjusted 1-sided alpha = 0.875%) of the difference between groups (NIBU minus IIBU), in terms of percentage of subjects with pneumococcal antibody concentrations ≥ 0.2 µg/mL, was lower than (\<) 10% for at least 7 out of the 10 pneumococcal serotypes.|Difference in percentages|-0.58|||||TWO_SIDED|98.25|-5.05|3.82||||||At one month after primary immunization, the difference between groups (NIBU minus IIBU), in terms of percentage of subjects with pneumococcal antibody concentrations ≥ 0.2 µg/mL were calculated for anti-pneumococccal serotype 9V.||3.82|-5.05|
72494101|NCT01390909|144517164|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|65.0||||0.1061|TWO_SIDED|95.0|-22.0|145.0||Adjusted Cost Differences in Neurologist Visits, Epilepsy-Related|Ordinary Least Squares Regression|Covariates were gender, age, region, comorbidities, AEDs and non-AEDs known to increase seizure risk and baseline costs.||||145|-22|0.1061
72494102|NCT01390909|144517164|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|58.0|||<|0.0001|TWO_SIDED|95.0|28.0|93.0||Adjusted Cost Differences in Other Healthcare Services, Epilepsy-Related|Ordinary Least Squares Regression|Covariates were gender, age, region, comorbidities, AEDs and non-AEDs known to increase seizure risk and baseline costs.||||93|28|<0.0001
72382617|NCT02047227|144273962|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.235||||0.054|TWO_SIDED|95.0|-0.4741|0.003|||Poisson Regression Model|||||0.003|-0.4741|0.054
72382618|NCT01977937|144273970|OTHER|Differences in average pre-operative \& total post-operative average VAS scores were compared between groups using an unpaired Mann-Whitney rank sum test. Hospitalization outcomes including number of days to transition off PCA, number of days with Foley catheter, \& episodes of nausea, emesis, or POSS \> 3 were compared between groups using an unpaired two-tailed Student's t-test. Statistical significance was defined as p\<0.05 for all unpaired parametric and non-parametric comparisons.||||||0.07|||||||t-test, 2 sided|||D'Agostino \& Pearson normality test was used to assess for normal distribution. Experimental \& control groups were assessed for significant differences in age, hospital days, \& spinal levels fused using unpaired two-tailed Student's t-test. Differences in weight \& BMI were assessed using unpaired Mann-Whitney rank sum test. Differences in average VAS scores on the operative day, each post-operative day, and average total daily opioid were compared using an unpaired two-tailed Student's t-test.||||0.07
72382619|NCT01977937|144273971|OTHER|||||||0.02|||||||t-test, 2 sided|||Differences in the average total daily opioid were compared between groups using an unpaired two-tailed Student's t-test||||0.02
72382620|NCT01209923|144273987|OTHER|||||||0.001|||||||t-test, 2 sided|Independent t-test||Children BIA was compared to hydrostatic weighing; adults were compared to DEXA.||||0.001
72382621|NCT00252629|144274006|SUPERIORITY_OR_OTHER|||||||0.0002|TWO_SIDED||||||t-test, 2 sided|||The change of fatigue complaint from baseline (before treatment) to post treatment ( after 3 weeks treatment) on either therapeutic CPAP or sham CPAP was compared with student t-test.||||0.0002
72382622|NCT00252629|144274007|SUPERIORITY_OR_OTHER|||||||0.0008|TWO_SIDED||||||t-test, 2 sided|||The change of pain symptom from baseline (before treatment) to post treatment ( after 3 weeks treatment) on either therapeutic CPAP or sham CPAP was compared with student t-test.||||0.0008
72382623|NCT00252629|144274008|SUPERIORITY_OR_OTHER|||||||0.004|TWO_SIDED||||||t-test, 2 sided|||The change of cognitive dysfunction complaint from baseline (before treatment) to post treatment ( after 3 weeks treatment) on either therapeutic CPAP or sham CPAP was compared with student t-test.||||0.004
72434790|NCT01235949|144383120|NON_INFERIORITY|Criterion for evaluation of non-inferiority: The upper limit (UL) of the 2-sided 98.25% confidence interval (98.25% CI) (adjusted 1-sided alpha = 0.875%) of the difference between groups (NIBU minus IIBU), in terms of percentage of subjects with pneumococcal antibody concentrations ≥ 0.2 µg/mL, was lower than (\<) 10% for at least 7 out of the 10 pneumococcal serotypes.|Difference in percentages|-0.65|||||TWO_SIDED|98.25|-4.68|3.15||||||At one month after primary immunization, the difference between groups (NIBU minus IIBU), in terms of percentage of subjects with pneumococcal antibody concentrations ≥ 0.2 µg/mL were calculated for anti-pneumococccal serotype 14.||3.15|-4.68|
72434791|NCT01235949|144383120|NON_INFERIORITY|Criterion for evaluation of non-inferiority: The upper limit (UL) of the 2-sided 98.25% confidence interval (98.25% CI) (adjusted 1-sided alpha = 0.875%) of the difference between groups (NIBU minus IIBU), in terms of percentage of subjects with pneumococcal antibody concentrations ≥ 0.2 µg/mL, was lower than (\<) 10% for at least 7 out of the 10 pneumococcal serotypes.|Difference in percentages|-0.58|||||TWO_SIDED|98.25|-5.04|3.85||||||At one month after primary immunization, the difference between groups (NIBU minus IIBU), in terms of percentage of subjects with pneumococcal antibody concentrations ≥ 0.2 µg/mL were calculated for anti-pneumococccal serotype 18C.||3.85|-5.04|
72434792|NCT01235949|144383120|NON_INFERIORITY|Criterion for evaluation of non-inferiority: The upper limit (UL) of the 2-sided 98.25% confidence interval (98.25% CI) (adjusted 1-sided alpha = 0.875%) of the difference between groups (NIBU minus IIBU), in terms of percentage of subjects with pneumococcal antibody concentrations ≥ 0.2 µg/mL, was lower than (\<) 10% for at least 7 out of the 10 pneumococcal serotypes.|Difference in percentages|-0.63|||||TWO_SIDED|98.25|-4.6|3.14||||||At one month after primary immunization, the difference between groups (NIBU minus IIBU), in terms of percentage of subjects with pneumococcal antibody concentrations ≥ 0.2 µg/mL were calculated for anti-pneumococccal serotype 19F.||3.14|-4.6|
72434793|NCT01235949|144383120|NON_INFERIORITY|Criterion for evaluation of non-inferiority: The upper limit (UL) of the 2-sided 98.25% confidence interval (98.25% CI) (adjusted 1-sided alpha = 0.875%) of the difference between groups (NIBU minus IIBU), in terms of percentage of subjects with pneumococcal antibody concentrations ≥ 0.2 µg/mL, was lower than (\<) 10% for at least 7 out of the 10 pneumococcal serotypes.|Difference in percentages|0.08||||||98.25|-7.66|8.1||||||At one month after primary immunization, the difference between groups (NIBU minus IIBU), in terms of percentage of subjects with pneumococcal antibody concentrations ≥ 0.2 µg/mL were calculated for anti-pneumococccal serotype 23F.||8.1|-7.66|
72434794|NCT01235949|144383120|NON_INFERIORITY|Criterion for evaluation of non-inferiority: The upper limit (UL) of the 2-sided 98.25% confidence interval (98.25% CI) (adjusted 1-sided alpha = 0.875%) of the difference between groups (NIBU minus DIBU), in terms of percentage of subjects with pneumococcal antibody concentrations ≥ 0.2 µg/mL, was lower than (\<) 10% for at least 7 out of the 10 pneumococcal serotypes.|Difference in percentages|-0.62|||||TWO_SIDED|98.25|-4.52|2.91||||||At one month after primary immunization, the difference between groups (NIBU minus DIBU), in terms of percentage of subjects with pneumococcal antibody concentrations ≥ 0.2 µg/mL were calculated for anti-pneumococccal serotype 1.||2.91|-4.52|
72434795|NCT01235949|144383120|NON_INFERIORITY|Criterion for evaluation of non-inferiority: The upper limit (UL) of the 2-sided 98.25% confidence interval (98.25% CI) (adjusted 1-sided alpha = 0.875%) of the difference between groups (NIBU minus DIBU), in terms of percentage of subjects with pneumococcal antibody concentrations ≥ 0.2 µg/mL, was lower than (\<) 10% for at least 7 out of the 10 pneumococcal serotypes.|Difference in percentages|-0.63|||||TWO_SIDED|98.25|-4.57|2.91||||||At one month after primary immunization, the difference between groups (NIBU minus DIBU), in terms of percentage of subjects with pneumococcal antibody concentrations ≥ 0.2 µg/mL were calculated for anti-pneumococccal serotype 4.||2.91|-4.57|
72618693|NCT01026038|144768108|SUPERIORITY_OR_OTHER||GMT ratio|2.7|||||TWO_SIDED|95.0|0.48|14.92||||||Serotype 18C: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||14.92|0.48|
72618694|NCT01026038|144768108|SUPERIORITY_OR_OTHER||GMT ratio|1.0|||||TWO_SIDED|95.0|0.23|4.36||||||Serotype 19F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||4.36|0.23|
72382624|NCT00252629|144274009|SUPERIORITY_OR_OTHER|||||||0.0001|TWO_SIDED||||||t-test, 2 sided|||The p value was based on t-test||||0.0001
72382625|NCT01278160|144274010|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.01|STANDARD_ERROR_OF_MEAN|0.12||||95.0|-0.24|0.22|||ANCOVA|The estimates were from a normal linear regression model with treatment and previous insulin as factors, and baseline value as a covariate.||The null hypothesis is H0: μBIAsp 30 (2:1) - μBIAsp 30 (1:1) = 0 against the alternative hypothesis HA: μBIAsp 30 (2:1) - μBIAsp 30 (1:1) ≠ 0. This trial is an extension to BIAsp-3756 (NCT01123980), hence no particular sample size calculation was made.||0.22|-0.24|
72382626|NCT01278160|144274011|SUPERIORITY_OR_OTHER||Mixed models analysis|0.2||||0.2569||95.0|-0.15|0.56||P-value for parallelism was overall test for parallel time profiles between treatment groups, i.e. time by treatment group interaction effect.|Mixed Models Analysis||Confidence interval is before breakfast profile|A mixed effect model was fitted to the 9-point SMPG profile data. The model included treatment, time, interaction between treatment and time and previous therapy (BIAsp 30 OD/insulin glargine OD) as factors and subject as random effect. From the model, mean profile by treatment and relevant treatment differences was estimated and explored.||0.56|-0.15|0.2569
72382627|NCT01278160|144274011|SUPERIORITY_OR_OTHER||Mixed models analysis|0.09||||0.812||95.0|-0.63|0.8||P-value for parallelism was overall test for parallel time profiles between treatment groups, i.e. time by treatment group interaction effect.|Mixed Models Analysis||Confidence interval is two hours after breakfast profile|A mixed effect model was fitted to the 9-point SMPG profile data. The model included treatment, time, interaction between treatment and time and previous therapy (BIAsp-30 once daily (OD)/insulin glargine OD) as factors and subject as random effect. From the model, mean profile by treatment and relevant treatment differences was estimated and explored.||0.80|-0.63|0.8120
72557471|NCT00205777|144645432|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.2||||0.191|TWO_SIDED|95.0|0.925|1.556|||Log Rank|||Osteoporosis-Related: P value was calculated using Log-Rank test. Hazard ratio (Bazedoxifene 20 mg \[Core+SE I\] versus Bazedoxifene 40/20 mg \[SE I\]) based on a Cox proportional hazards regression model was presented along with 95% CIs.||1.556|0.925|0.191
72557472|NCT00205777|144645432|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.406||||0.493|TWO_SIDED|95.0|0.566|3.497|||Log Rank|||Hip: P value was calculated using Log-Rank test. Hazard ratio (Bazedoxifene 20 mg \[Core+SE I\] versus Placebo \[Core+SE I+SE II\]) based on a Cox proportional hazards regression model was presented along with 95% CIs.||3.497|0.566|0.493
72618695|NCT01026038|144768108|SUPERIORITY_OR_OTHER||GMT ratio|1.2|||||TWO_SIDED|95.0|0.31|4.84||||||Serotype 19F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||4.84|0.31|
72382628|NCT01278160|144274011|SUPERIORITY_OR_OTHER||Mixed model analysis|0.35||||0.2843||95.0|-0.29|0.99||P-value for parallelism was overall test for parallel time profiles between treatment groups, i.e. time by treatment group interaction effect.|Mixed Models Analysis||Confidence interval is before lunch profile|A mixed effect model was fitted to the 9-point SMPG profile data. The model included treatment, time, interaction between treatment and time and previous therapy (BIAsp-30 once daily (OD)/insulin glargine OD) as factors and subject as random effect. From the model, mean profile by treatment and relevant treatment differences was estimated and explored.||0.99|-0.29|0.2843
72382629|NCT01278160|144274011|SUPERIORITY_OR_OTHER||Mixed model analysis|0.3||||0.4614||95.0|-0.5|1.11||P-value for parallelism was overall test for parallel time profiles between treatment groups, i.e. time by treatment group interaction effect.|Mixed Models Analysis||Confidence interval is two hours after lunch profile|A mixed effect model was fitted to the 9-point SMPG profile data. The model included treatment, time, interaction between treatment and time and previous therapy (BIAsp-30 once daily (OD)/insulin glargine OD) as factors and subject as random effect. From the model, mean profile by treatment and relevant treatment differences was estimated and explored.||1.11|-0.50|0.4614
72382630|NCT01278160|144274011|SUPERIORITY_OR_OTHER||Mixed model analysis|0.44||||0.1591||95.0|-0.17|1.04||P-value for parallelism was overall test for parallel time profiles between treatment groups, i.e. time by treatment group interaction effect.|Mixed Models Analysis||Confidence interval is before dinner profile|A mixed effect model was fitted to the 9-point SMPG profile data. The model included treatment, time, interaction between treatment and time and previous therapy (BIAsp-30 once daily (OD)/insulin glargine OD) as factors and subject as random effect. From the model, mean profile by treatment and relevant treatment differences was estimated and explored.||1.04|-0.17|0.1591
72382631|NCT01278160|144274011|SUPERIORITY_OR_OTHER||Mixed model analysis|0.03||||0.9327||95.0|-0.63|0.69||P-value for parallelism was overall test for parallel time profiles between treatment groups, i.e. time by treatment group interaction effect.|Mixed Models Analysis||Confidence interval is two hours after dinner profile|A mixed effect model was fitted to the 9-point SMPG profile data. The model included treatment, time, interaction between treatment and time and previous therapy (BIAsp-30 once daily (OD)/insulin glargine OD) as factors and subject as random effect. From the model, mean profile by treatment and relevant treatment differences was estimated and explored.||0.69|-0.63|0.9327
72494103|NCT01390909|144517164|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7673.0|||<|0.0001|TWO_SIDED|95.0|4571.0|10989.0||Adjusted Cost Differences in Total Healthcare Costs|Ordinary Least Squares Regression|Covariates were gender, age, region, comorbidities, AEDs and non-AEDs known to increase seizure risk and baseline costs.||||10989|4571|<0.0001
72494104|NCT03237065|144517203|SUPERIORITY||Risk Difference (RD)|-65.8|||<|0.0001|TWO_SIDED|95.0|-76.6|-49.8|||Cochran-Mantel-Haenszel|Rate difference with 95% Newcombe confidence intervals (CI) adjusted for stratum, using the Cochran-Mantel-Haenszel method.|Iron isomaltoside/ferric derisomaltose was compared to ferric carboxymaltose by estimation of the risk difference and the associated 95% CI, adjusting for strata (underlying disease and screening s-phosphate) using the Cochran-Mantel-Haenszel method.|"Power:~The power was set to 80%. Assuming incidences of 15% for iron isomaltoside/ferric derisomaltose and 40% for ferric carboxymaltose, 49 subjects in each treatment group were required to detect a difference between the treatment groups. The significance level was set to 5%."||-49.8|-76.6|<0.0001
72494105|NCT03237065|144517204|SUPERIORITY|||||||0.0511|||||||Log Rank|||The time with hypophosphatemia from baseline to day 35 was estimated by a Kaplan- Meier plot. The treatment groups were compared by a log-rank test. Only subjects who had one or more s-phosphate value(s) \<2 mg/dL were included.||||0.0511
72494106|NCT03237065|144517205|SUPERIORITY||Risk Difference (RD)|-44.6|||<|0.0001|TWO_SIDED|95.0|-57.7|-31.6|||Cochran-Mantel-Haenszel|||Iron isomaltoside/ferric derisomaltose was compared to ferric carboxymaltose by estimation of the risk difference and the associated 95 % CI, adjusting for strata (type of underlying disease (women with IDA due to gynaecological blood losses; yes/no) and screening s-phosphate level (\< or ≥ 3.5 mg/dL)) using the Cochran-Mantel-Haenszel method.||-31.6|-57.7|<0.0001
72494107|NCT03237065|144517206|SUPERIORITY||Mean Difference (Final Values)|0.46|||<|0.0001|TWO_SIDED|95.0|0.3|0.62|||Mixed model for repeated measures|||"Day 1~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||0.62|0.30|<0.0001
72494108|NCT03237065|144517206|SUPERIORITY||Mean Difference (Final Values)|0.54|||<|0.0001|TWO_SIDED|95.0|0.32|0.76|||Mixed model for repeated measures|||"Day 7~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||0.76|0.32|<0.0001
72557473|NCT00205777|144645432|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.872||||0.82|TWO_SIDED|95.0|0.316|2.405|||Log Rank|||Hip: P value was calculated using Log-Rank test. Hazard ratio (Bazedoxifene 40/20 mg \[SE I\] versus Placebo \[Core+SE I+SE II\]) based on a Cox proportional hazards regression model was presented along with 95% CIs.||2.405|0.316|0.820
72557474|NCT00205777|144645432|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.612||||0.371|TWO_SIDED|95.0|0.624|4.161|||Log Rank|||Hip: P value was calculated using Log-Rank test. Hazard ratio (Bazedoxifene 20 mg \[Core+SE I\] versus Bazedoxifene 40/20 mg \[SE I\]) based on a Cox proportional hazards regression model was presented along with 95% CIs.||4.161|0.624|0.371
72557475|NCT00205777|144645432|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.202||||0.423|TWO_SIDED|95.0|0.776|1.861|||Log Rank|||Wrist: P value was calculated using Log-Rank test. Hazard ratio (Bazedoxifene 20 mg \[Core+SE I\] versus Placebo \[Core+SE I+SE II\]) based on a Cox proportional hazards regression model was presented along with 95% CIs.||1.861|0.776|0.423
72557476|NCT00205777|144645432|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.936||||0.799|TWO_SIDED|95.0|0.587|1.491|||Log Rank|||Wrist: P value was calculated using Log-Rank test. Hazard ratio (Bazedoxifene 40/20 mg \[SE I\] versus Placebo \[Core+SE I+SE II\]) based on a Cox proportional hazards regression model was presented along with 95% CIs.||1.491|0.587|0.799
72557477|NCT00205777|144645432|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.28||||0.298|TWO_SIDED|95.0|0.818|2.002|||Log Rank|||Wrist: P value was calculated using Log-Rank test. Hazard ratio (Bazedoxifene 20 mg \[Core+SE I\] versus Bazedoxifene 40/20 mg \[SE I\]) based on a Cox proportional hazards regression model was presented along with 95% CIs.||2.002|0.818|0.298
72557478|NCT00205777|144645433|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.96||||0.73|TWO_SIDED|95.0|0.78|1.19|||Log Rank|||Osteoporosis-Related: P value was calculated using Log-Rank test. Hazard ratio (Bazedoxifene 20 mg \[SE II\] versus Placebo \[Core+SE I+SE II\]) based on a Cox proportional hazards regression model was presented along with 95% CIs.||1.19|0.78|0.73
72557479|NCT00205777|144645433|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.87||||0.71|TWO_SIDED|95.0|0.41|1.83|||Log Rank|||Hip: P value was calculated using Log-Rank test. Hazard ratio (Bazedoxifene 20 mg \[SE II\] versus Placebo \[Core+SE I+SE II\]) based on a Cox proportional hazards regression model was presented along with 95% CIs.||1.83|0.41|0.71
72557480|NCT00205777|144645433|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.15||||0.45|TWO_SIDED|95.0|0.8|1.66|||Log Rank|||Wrist: P value was calculated using Log-Rank test. Hazard ratio (Bazedoxifene 20 mg \[SE II\] versus Placebo \[Core+SE I+SE II\]) based on a Cox proportional hazards regression model was presented along with 95% CIs.||1.66|0.80|0.45
72557481|NCT00205777|144645434|SUPERIORITY_OR_OTHER|||||||0.31|TWO_SIDED||||||ANCOVA|||||||0.31
72557482|NCT00205777|144645434|SUPERIORITY_OR_OTHER|||||||0.039|TWO_SIDED||||||ANCOVA|||||||0.039
72382632|NCT01278160|144274011|SUPERIORITY_OR_OTHER||Mixed model analysis|-0.25||||0.4063||95.0|-0.84|0.34||P-value for parallelism was overall test for parallel time profiles between treatment groups, i.e. time by treatment group interaction effect.|Mixed Models Analysis||Confidence interval is bedtime profile|A mixed effect model was fitted to the 9-point SMPG profile data. The model included treatment, time, interaction between treatment and time and previous therapy (BIAsp-30 once daily (OD)/insulin glargine OD) as factors and subject as random effect. From the model, mean profile by treatment and relevant treatment differences was estimated and explored.||0.34|-0.84|0.4063
72382633|NCT01278160|144274011|SUPERIORITY_OR_OTHER||Mixed model analysis|0.3||||0.2198||95.0|-0.18|0.79||P-value for parallelism was overall test for parallel time profiles between treatment groups, i.e. time by treatment group interaction effect.|Mixed Models Analysis||Confidence interval is 2.00 - 4.00 a.m. profile|A mixed effect model was fitted to the 9-point SMPG profile data. The model included treatment, time, interaction between treatment and time and previous therapy (BIAsp-30 once daily (OD)/insulin glargine OD) as factors and subject as random effect. From the model, mean profile by treatment and relevant treatment differences was estimated and explored.||0.79|-0.18|0.2198
72557483|NCT00205777|144645434|SUPERIORITY_OR_OTHER|||||||0.13|TWO_SIDED||||||ANCOVA|||||||0.13
72557484|NCT00205777|144645434|SUPERIORITY_OR_OTHER|||||||0.12|TWO_SIDED||||||ANCOVA|||||||0.12
72557485|NCT00205777|144645434|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED||||||ANCOVA|||||||0.002
72557486|NCT00205777|144645435|SUPERIORITY_OR_OTHER|||||||0.12|TWO_SIDED||||||ANCOVA|||||||0.12
72557487|NCT00205777|144645435|SUPERIORITY_OR_OTHER|||||||0.94|TWO_SIDED||||||ANCOVA|||||||0.94
72557488|NCT00205777|144645436|SUPERIORITY_OR_OTHER|||||||0.26|TWO_SIDED||||||ANCOVA|||||||0.26
72557489|NCT00205777|144645437|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 6 in lumbar spine BMD: P value was calculated using Analysis of covariance (ANCOVA).||||<0.001
72557490|NCT00205777|144645437|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 12 in lumbar spine BMD: P value was calculated using ANCOVA.||||<0.001
72557491|NCT00205777|144645437|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 18 in lumbar spine BMD: P value was calculated using ANCOVA.||||<0.001
72557492|NCT00205777|144645437|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 24 in lumbar spine BMD: P value was calculated using ANCOVA.||||<0.001
72557493|NCT00205777|144645437|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 36 in lumbar spine BMD: P value was calculated using ANCOVA.||||<0.001
72557494|NCT00205777|144645437|SUPERIORITY_OR_OTHER|||||||0.018|TWO_SIDED||||||ANCOVA|||Percent change at Month 6 in lumbar spine BMD: P value was calculated using ANCOVA.||||0.018
72557495|NCT00205777|144645437|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 12 in lumbar spine BMD: P value was calculated using ANCOVA.||||<0.001
72557496|NCT00205777|144645437|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 18 in lumbar spine BMD: P value was calculated using ANCOVA.||||<0.001
72557497|NCT00205777|144645437|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 24 in lumbar spine BMD: P value was calculated using ANCOVA.||||<0.001
72557498|NCT00205777|144645437|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 36 in lumbar spine BMD: P value was calculated using ANCOVA.||||<0.001
72557499|NCT00205777|144645437|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 6 in lumbar spine BMD: P value was calculated using ANCOVA.||||<0.001
72557500|NCT00205777|144645437|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 12 in lumbar spine BMD: P value was calculated using ANCOVA.||||<0.001
72557501|NCT00205777|144645437|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 18 in lumbar spine BMD: P value was calculated using ANCOVA.||||<0.001
72557502|NCT00205777|144645437|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 24 in lumbar spine BMD: P value was calculated using ANCOVA.||||<0.001
72557503|NCT00205777|144645437|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 36 in lumbar spine BMD: P value was calculated using ANCOVA.||||<0.001
72557504|NCT00205777|144645437|SUPERIORITY_OR_OTHER|||||||0.036|TWO_SIDED||||||ANCOVA|||Percent change at Month 6 in lumbar spine BMD: P value was calculated using ANCOVA.||||0.036
72557505|NCT00205777|144645437|SUPERIORITY_OR_OTHER|||||||0.003|TWO_SIDED||||||ANCOVA|||Percent change at Month 12 in lumbar spine BMD: P value was calculated using ANCOVA.||||0.003
72557506|NCT00205777|144645437|SUPERIORITY_OR_OTHER|||||||0.019|TWO_SIDED||||||ANCOVA|||Percent change at Month 18 in lumbar spine BMD: P value was calculated using ANCOVA.||||0.019
72382634|NCT01278160|144274011|SUPERIORITY_OR_OTHER||Mixed model analysis|-0.04||||0.8424||95.0|-0.47|0.38|||Mixed Models Analysis||Confidence interval is before breakfast the following day profile|A mixed effect model was fitted to the 9-point SMPG profile data. The model included treatment, time, interaction between treatment and time and previous therapy (BIAsp-30 once daily (OD)/insulin glargine OD) as factors and subject as random effect. From the model, mean profile by treatment and relevant treatment differences was estimated and explored.||0.38|-0.47|0.8424
72382635|NCT01278160|144274012|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.86||||0.7312||95.0|0.36|2.06|||Regression, Logistic||The odds ratio and 95% confidence interval for the HbA1c below 7% treatment target were included.|Responder analyses were based on logistics regression model using treatment and previous therapy (BIAsp 30 OD or insulin glargine OD) as factors and baseline HbA1c as covariate.||2.06|0.36|0.7312
72382636|NCT01278160|144274013|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.27||||0.1257||95.0|0.05|1.44|||Regression, Logistic|The estimates were from a normal linear regression model with treatment and previous insulin as factors, and baseline value as a covariate|The odds ratio and 95% confidence interval for the HbA1c below or equal to 6.5% treatment target were included.|Responder analyses were based on logistics regression model using treatment and previous therapy (BIAsp 30 OD or insulin glargine OD) as factors and baseline HbA1c as covariate.||1.44|0.05|0.1257
72382637|NCT01278160|144274014|SUPERIORITY_OR_OTHER||Rate ratio|0.72||||0.1911||95.0|0.43|1.18|||Negative binomial regression model||For all episodes.|The number of hypos was analysed using a negative binomial regression model with a log-link function and the logarithm of the time period in which a hypo is considered emergent as offset. The model included treatment and previous therapy (BIAsp 30 OD/insulin glargine OD) as factors. The rate ratio was estimated and 95% confidence intervals were calculated accordingly.||1.18|0.43|0.1911
72382638|NCT01278160|144274014|SUPERIORITY_OR_OTHER||Rate ratio|1.61||||0.2949||95.0|0.66|3.92|||Negative binomial regression model||For nocturnal episodes.|The number of hypos was analysed using a negative binomial regression model with a log-link function and the logarithm of the time period in which a hypo is considered emergent as offset. The model included treatment and previous therapy (BIAsp 30 OD/insulin glargine OD) as factors. The rate ratio was estimated and 95% confidence intervals were calculated accordingly.||3.92|0.66|0.2949
72382639|NCT01278160|144274014|SUPERIORITY_OR_OTHER||Rate ratio|0.63||||0.077||95.0|0.38|1.05|||Negative binomial regression model||For diurnal episodes.|The number of hypos was analysed using a negative binomial regression model with a log-link function and the logarithm of the time period in which a hypo is considered emergent as offset. The model included treatment and previous therapy (BIAsp 30 OD/insulin glargine OD) as factors. The rate ratio was estimated and 95% confidence intervals were calculated accordingly.||1.05|0.38|0.0770
72382640|NCT01278160|144274014|SUPERIORITY_OR_OTHER||Rate ratio|0.56||||0.1687||95.0|0.25|1.27|||Negative binomial regression model||For minor episodes.|The number of hypos was analysed using a negative binomial regression model with a log-link function and the logarithm of the time period in which a hypo is considered emergent as offset. The model included treatment and previous therapy (BIAsp 30 OD/insulin glargine OD) as factors. The rate ratio was estimated and 95% confidence intervals were calculated accordingly.||1.27|0.25|0.1687
72382641|NCT01483807|144274017|SUPERIORITY||Mean Difference (Final Values)|0.7||||0.254|ONE_SIDED||||||t-test, 1 sided|||Comparison of performance (change in articulation accuracy) with SPT-R versus SPT-B items. Based on the existing literature, it was predicted that the mean effect size associated with SPT-R would be greater than that for SPT-B.||||.254
72382642|NCT01483807|144274018|SUPERIORITY||Mean Difference (Final Values)|8.25||||0.043|ONE_SIDED||||||t-test, 1 sided|||On the basis of existing literature. SPT-R was predicted to be associated with greater increase in articulatory accuracy over baseline levels than SPT-B.||||.043
72382643|NCT01483807|144274019|SUPERIORITY|||||||0.396|||||||t-test, 1 sided|||Comparison of change in accuracy of articulation of untreated items: SPT-R versus SPT-B items. It was predicted that there would be a greater increase in accuracy for SPT-R items.||||.396
72557507|NCT00205777|144645437|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 24 in lumbar spine BMD: P value was calculated using ANCOVA.||||<0.001
72557508|NCT00205777|144645437|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED||||||ANCOVA|||Percent change at Month 36 in lumbar spine BMD: P value was calculated using ANCOVA.||||0.002
72557509|NCT00205777|144645437|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 6 in lumbar spine BMD: P value was calculated using ANCOVA.||||<0.001
72557510|NCT00205777|144645437|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 12 in lumbar spine BMD: P value was calculated using ANCOVA.||||<0.001
72557511|NCT00205777|144645437|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 18 in lumbar spine BMD: P value was calculated using ANCOVA.||||<0.001
72557512|NCT00205777|144645437|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 24 in lumbar spine BMD: P value was calculated using ANCOVA.||||<0.001
72557513|NCT00205777|144645437|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 36 in lumbar spine BMD: P value was calculated using ANCOVA.||||<0.001
72557514|NCT00205777|144645437|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 6 in total hip BMD: P value was calculated using ANCOVA.||||<0.001
72557515|NCT00205777|144645437|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 12 in total hip BMD: P value was calculated using ANCOVA.||||<0.001
72557516|NCT00205777|144645437|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 18 in total hip BMD: P value was calculated using ANCOVA.||||<0.001
72557517|NCT00205777|144645437|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 24 in total hip BMD: P value was calculated using ANCOVA.||||<0.001
72557518|NCT00205777|144645437|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 36 in total hip BMD: P value was calculated using ANCOVA.||||<0.001
72434796|NCT01235949|144383120|NON_INFERIORITY|Criterion for evaluation of non-inferiority: The upper limit (UL) of the 2-sided 98.25% confidence interval (98.25% CI) (adjusted 1-sided alpha = 0.875%) of the difference between groups (NIBU minus DIBU), in terms of percentage of subjects with pneumococcal antibody concentrations ≥ 0.2 µg/mL, was lower than (\<) 10% for at least 7 out of the 10 pneumococcal serotypes.|Difference in percentages|-0.64|||||TWO_SIDED|98.25|-4.63|2.92||||||At one month after primary immunization, the difference between groups (NIBU minus DIBU), in terms of percentage of subjects with pneumococcal antibody concentrations ≥ 0.2 µg/mL were calculated for anti-pneumococccal serotype 5.||2.92|-4.63|
72434797|NCT01235949|144383120|NON_INFERIORITY|Criterion for evaluation of non-inferiority: The upper limit (UL) of the 2-sided 98.25% confidence interval (98.25% CI) (adjusted 1-sided alpha = 0.875%) of the difference between groups (NIBU minus DIBU), in terms of percentage of subjects with pneumococcal antibody concentrations ≥ 0.2 µg/mL, was lower than (\<) 10% for at least 7 out of the 10 pneumococcal serotypes.|Difference in percentages|-2.38|||||TWO_SIDED|98.25|-12.02|7.22||||||At one month after primary immunization, the difference between groups (NIBU minus DIBU), in terms of percentage of subjects with pneumococcal antibody concentrations ≥ 0.2 µg/mL were calculated for anti-pneumococccal serotype 6B.||7.22|-12.02|
72434798|NCT01235949|144383120|NON_INFERIORITY|Criterion for evaluation of non-inferiority: The upper limit (UL) of the 2-sided 98.25% confidence interval (98.25% CI) (adjusted 1-sided alpha = 0.875%) of the difference between groups (NIBU minus DIBU), in terms of percentage of subjects with pneumococcal antibody concentrations ≥ 0.2 µg/mL, was lower than (\<) 10% for at least 7 out of the 10 pneumococcal serotypes.|Difference in percentages|0.0|||||TWO_SIDED|98.25|-3.34|3.48||||||At one month after primary immunization, the difference between groups (NIBU minus DIBU), in terms of percentage of subjects with pneumococcal antibody concentrations ≥ 0.2 µg/mL were calculated for anti-pneumococccal serotype 7F.||3.48|-3.34|
72434799|NCT01235949|144383120|NON_INFERIORITY|Criterion for evaluation of non-inferiority: The upper limit (UL) of the 2-sided 98.25% confidence interval (98.25% CI) (adjusted 1-sided alpha = 0.875%) of the difference between groups (NIBU minus DIBU), in terms of percentage of subjects with pneumococcal antibody concentrations ≥ 0.2 µg/mL, was lower than (\<) 10% for at least 7 out of the 10 pneumococcal serotypes.|Difference in percentages|-1.27|||||TWO_SIDED|98.25|-5.66|2.32||||||At one month after primary immunization, the difference between groups (NIBU minus DIBU), in terms of percentage of subjects with pneumococcal antibody concentrations ≥ 0.2 µg/mL were calculated for anti-pneumococccal serotype 9V.||2.32|-5.66|
72434800|NCT01235949|144383120|NON_INFERIORITY|Criterion for evaluation of non-inferiority: The upper limit (UL) of the 2-sided 98.25% confidence interval (98.25% CI) (adjusted 1-sided alpha = 0.875%) of the difference between groups (NIBU minus DIBU), in terms of percentage of subjects with pneumococcal antibody concentrations ≥ 0.2 µg/mL, was lower than (\<) 10% for at least 7 out of the 10 pneumococcal serotypes.|Difference in percentages|0.0|||||TWO_SIDED|98.25|-4.08|4.12||||||At one month after primary immunization, the difference between groups (NIBU minus DIBU), in terms of percentage of subjects with pneumococcal antibody concentrations ≥ 0.2 µg/mL were calculated for anti-pneumococccal serotype 14.||4.12|-4.08|
72434801|NCT01235949|144383120|NON_INFERIORITY|Criterion for evaluation of non-inferiority: The upper limit (UL) of the 2-sided 98.25% confidence interval (98.25% CI) (adjusted 1-sided alpha = 0.875%) of the difference between groups (NIBU minus DIBU), in terms of percentage of subjects with pneumococcal antibody concentrations ≥ 0.2 µg/mL, was lower than (\<) 10% for at least 7 out of the 10 pneumococcal serotypes.|Difference in percentages|-0.62|||||TWO_SIDED|98.25|-5.08|3.54||||||At one month after primary immunization, the difference between groups (NIBU minus DIBU), in terms of percentage of subjects with pneumococcal antibody concentrations ≥ 0.2 µg/mL were calculated for anti-pneumococccal serotype 18C.||3.54|-5.08|
72434802|NCT01235949|144383120|NON_INFERIORITY|Criterion for evaluation of non-inferiority: The upper limit (UL) of the 2-sided 98.25% confidence interval (98.25% CI) (adjusted 1-sided alpha = 0.875%) of the difference between groups (NIBU minus DIBU), in terms of percentage of subjects with pneumococcal antibody concentrations ≥ 0.2 µg/mL, was lower than (\<) 10% for at least 7 out of the 10 pneumococcal serotypes.|Difference in percentages|0.67|||||TWO_SIDED|98.25|-3.4|5.2||||||At one month after primary immunization, the difference between groups (NIBU minus DIBU), in terms of percentage of subjects with pneumococcal antibody concentrations ≥ 0.2 µg/mL were calculated for anti-pneumococccal serotype 19F.||5.2|-3.4|
72494109|NCT03237065|144517206|SUPERIORITY||Mean Difference (Final Values)|0.73|||<|0.0001|TWO_SIDED|95.0|0.49|0.96|||Mixed model for repeated measures|||"Day 8~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||0.96|0.49|<0.0001
72557519|NCT00205777|144645437|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 6 in total hip BMD: P value was calculated using ANCOVA.||||<0.001
72557520|NCT00205777|144645437|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 12 in total hip BMD: P value was calculated using ANCOVA.||||<0.001
72557521|NCT00205777|144645437|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 18 in total hip BMD: P value was calculated using ANCOVA.||||<0.001
72557522|NCT00205777|144645437|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 24 in total hip BMD: P value was calculated using ANCOVA.||||<0.001
72557523|NCT00205777|144645437|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 36 in total hip BMD: P value was calculated using ANCOVA.||||<0.001
72557524|NCT00205777|144645437|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 6 in total hip BMD: P value was calculated using ANCOVA.||||<0.001
72618696|NCT01026038|144768108|SUPERIORITY_OR_OTHER||GMT ratio|1.2|||||TWO_SIDED|95.0|0.23|6.65||||||Serotype 19F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||6.65|0.23|
72618697|NCT01026038|144768108|SUPERIORITY_OR_OTHER||GMT ratio|0.9|||||TWO_SIDED|95.0|0.17|4.17||||||Serotype 23F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||4.17|0.17|
72557525|NCT00205777|144645437|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 12 in total hip BMD: P value was calculated using ANCOVA.||||<0.001
72557526|NCT00205777|144645437|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 18 in total hip BMD: P value was calculated using ANCOVA.||||<0.001
72557527|NCT00205777|144645437|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 24 in total hip BMD: P value was calculated using ANCOVA.||||<0.001
72557528|NCT00205777|144645437|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 36 in total hip BMD: P value was calculated using ANCOVA.||||<0.001
72557529|NCT00205777|144645437|SUPERIORITY_OR_OTHER|||||||0.008|TWO_SIDED||||||ANCOVA|||Percent change at Month 6 in total hip BMD: P value was calculated using ANCOVA.||||0.008
72557530|NCT00205777|144645437|SUPERIORITY_OR_OTHER|||||||0.007|TWO_SIDED||||||ANCOVA|||Percent change at Month 12 in total hip BMD: P value was calculated using ANCOVA.||||0.007
72557531|NCT00205777|144645437|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED||||||ANCOVA|||Percent change at Month 18 in total hip BMD: P value was calculated using ANCOVA.||||0.002
72557532|NCT00205777|144645437|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED||||||ANCOVA|||Percent change at Month 24 in total hip BMD: P value was calculated using ANCOVA.||||0.002
72557533|NCT00205777|144645437|SUPERIORITY_OR_OTHER|||||||0.006|TWO_SIDED||||||ANCOVA|||Percent change at Month 36 in total hip BMD: P value was calculated using ANCOVA.||||0.006
72557534|NCT00205777|144645437|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 6 in total hip BMD: P value was calculated using ANCOVA.||||<0.001
72557535|NCT00205777|144645437|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 12 in total hip BMD: P value was calculated using ANCOVA.||||<0.001
72382644|NCT01483807|144274020|SUPERIORITY|||||||0.212|||||||t-test, 1 sided|||Comparison of effect sizes obtained for untreated SPT-R versus untreated SPT-B items. It was predicted that effect sizes would be greater for SPT-R untreated items.||||.212
72382645|NCT02819518|144274023|SUPERIORITY||Hazard Ratio (HR)|0.82||||0.012|TWO_SIDED|95.0|0.7|0.98||One-sided p-value based on log-rank test stratified by chemotherapy (taxane versus \[vs\] gemcitabine/carboplatin), tumor PD-L1 status (CPS ≥1 vs CPS \<1) and prior treatment with same class of chemotherapy in the (neo)adjuvant setting (yes vs. no).|Log Rank||Based on Cox regression model with treatment as a covariate stratified by chemotherapy on study, tumor PD-L1 status, and prior treatment with same class of chemotherapy in the (neo)adjuvant setting.|||0.98|0.70|0.0120
72557536|NCT00205777|144645437|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 18 in total hip BMD: P value was calculated using ANCOVA.||||<0.001
72557537|NCT00205777|144645437|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 24 in total hip BMD: P value was calculated using ANCOVA.||||<0.001
72557538|NCT00205777|144645437|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 36 in total hip BMD: P value was calculated using ANCOVA.||||<0.001
72557539|NCT00205777|144645437|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 6 in femoral neck BMD: P value was calculated using ANCOVA.||||<0.001
72557540|NCT00205777|144645437|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 12 in femoral neck BMD: P value was calculated using ANCOVA.||||<0.001
72557541|NCT00205777|144645437|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 18 in femoral neck BMD: P value was calculated using ANCOVA.||||<0.001
72557542|NCT00205777|144645437|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 24 in femoral neck BMD: P value was calculated using ANCOVA.||||<0.001
72557543|NCT00205777|144645437|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 36 in femoral neck BMD: P value was calculated using ANCOVA.||||<0.001
72557544|NCT00205777|144645437|SUPERIORITY_OR_OTHER|||||||0.47|TWO_SIDED||||||ANCOVA|||Percent change at Month 6 in femoral neck BMD: P value was calculated using ANCOVA.||||0.47
72557545|NCT00205777|144645437|SUPERIORITY_OR_OTHER|||||||0.005|TWO_SIDED||||||ANCOVA|||Percent change at Month 12 in femoral neck BMD: P value was calculated using ANCOVA.||||0.005
72557546|NCT00205777|144645437|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED||||||ANCOVA|||Percent change at Month 18 in femoral neck BMD: P value was calculated using ANCOVA.||||0.002
72557547|NCT00205777|144645437|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 24 in femoral neck BMD: P value was calculated using ANCOVA.||||<0.001
72557548|NCT00205777|144645437|SUPERIORITY_OR_OTHER|||||||0.004|TWO_SIDED||||||ANCOVA|||Percent change at Month 36 in femoral neck BMD: P value was calculated using ANCOVA.||||0.004
72557549|NCT00205777|144645437|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 6 in femoral neck BMD: P value was calculated using ANCOVA.||||<0.001
72557550|NCT00205777|144645437|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 12 in femoral neck BMD: P value was calculated using ANCOVA.||||<0.001
72557551|NCT00205777|144645437|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 18 in femoral neck BMD: P value was calculated using ANCOVA.||||<0.001
72557552|NCT00205777|144645437|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 24 in femoral neck BMD: P value was calculated using ANCOVA.||||<0.001
72557553|NCT00205777|144645437|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 36 in femoral neck BMD: P value was calculated using ANCOVA.||||<0.001
72557554|NCT00205777|144645437|SUPERIORITY_OR_OTHER|||||||0.39|TWO_SIDED||||||ANCOVA|||Percent change at Month 6 in femoral neck BMD: P value was calculated using ANCOVA.||||0.39
72557555|NCT00205777|144645437|SUPERIORITY_OR_OTHER|||||||0.17|TWO_SIDED||||||ANCOVA|||Percent change at Month 12 in femoral neck BMD: P value was calculated using ANCOVA.||||0.17
72557556|NCT00205777|144645437|SUPERIORITY_OR_OTHER|||||||0.34|TWO_SIDED||||||ANCOVA|||Percent change at Month 18 in femoral neck BMD: P value was calculated using ANCOVA.||||0.34
72557557|NCT00205777|144645437|SUPERIORITY_OR_OTHER|||||||0.016|TWO_SIDED||||||ANCOVA|||Percent change at Month 24 in femoral neck BMD: P value was calculated using ANCOVA.||||0.016
72557558|NCT00205777|144645437|SUPERIORITY_OR_OTHER|||||||0.47|TWO_SIDED||||||ANCOVA|||Percent change at Month 36 in femoral neck BMD: P value was calculated using ANCOVA.||||0.47
72382646|NCT02819518|144274024|SUPERIORITY||Hazard Ratio (HR)|0.75||||0.0016|TWO_SIDED|95.0|0.62|0.91||One-sided p-value based on log-rank test stratified by chemotherapy on study (taxane vs gemcitabine/carboplatin), and prior treatment with same class of chemotherapy in the (neo)adjuvant setting (yes vs no).|Log Rank||Based on Cox regression model with treatment as a covariate stratified by chemotherapy on study, and prior treatment with same class of chemotherapy in the (neo)adjuvant setting.|||0.91|0.62|0.0016
72382647|NCT02819518|144274025|SUPERIORITY||Hazard Ratio (HR)|0.66||||0.0018|TWO_SIDED|95.0|0.5|0.88||One-sided p-value based on log-rank test stratified by chemotherapy on study (taxane vs gemcitabine/carboplatin), and prior treatment with same class of chemotherapy in the (neo)adjuvant setting (yes vs no).|Log Rank||Based on Cox regression model with treatment as a covariate stratified by chemotherapy on study, and prior treatment with same class of chemotherapy in the (neo)adjuvant setting.|||0.88|0.50|0.0018
72382648|NCT02819518|144274026|SUPERIORITY||Hazard Ratio (HR)|0.89||||0.0797|TWO_SIDED|95.0|0.76|1.05||One-sided p-value based on log-rank test stratified by chemotherapy on study (taxane vs gemcitabine/carboplatin), tumor PD-L1 status (CPS ≥1 vs CPS \<1) and prior treatment with same class of chemotherapy in the (neo)adjuvant setting (yes vs no).|Log Rank||Based on Cox regression model with treatment as a covariate stratified by chemotherapy on study, tumor PD-L1 status, and prior treatment with same class of chemotherapy in the (neo)adjuvant setting.|||1.05|0.76|0.0797
72382649|NCT02819518|144274027|SUPERIORITY||Hazard Ratio (HR)|0.86||||0.0563|TWO_SIDED|95.0|0.72|1.04||One-sided p-value based on log-rank test stratified by chemotherapy on study (taxane vs gemcitabine/carboplatin), and prior treatment with same class of chemotherapy in the (neo)adjuvant setting (yes vs no).|Log Rank||Based on Cox regression model with treatment as a covariate stratified by chemotherapy on study, and prior treatment with same class of chemotherapy in the (neo)adjuvant setting.|||1.04|0.72|0.0563
72382650|NCT02819518|144274028|SUPERIORITY||Hazard Ratio (HR)|0.73||||0.0093|TWO_SIDED|95.0|0.55|0.95||One-sided p-value based on log-rank test stratified by chemotherapy on study (taxane vs gemcitabine/carboplatin), and prior treatment with same class of chemotherapy in the (neo)adjuvant setting (yes vs no).|Log Rank||Based on Cox regression model with treatment as a covariate stratified by chemotherapy on study, and prior treatment with same class of chemotherapy in the (neo)adjuvant setting.|||0.95|0.55|0.0093
72382651|NCT02819518|144274029|SUPERIORITY||Difference in ORR (%) vs. Control|3.8||||0.1413|TWO_SIDED|95.0|-3.2|10.6|||Cochran-Mantel-Haenszel||Based on Miettinen \& Nurminen method stratified by chemotherapy on study (taxane vs gemcitabine/carboplatin), tumor PD-L1 status (CPS ≥1 vs CPS \<1) and prior treatment with same class of chemotherapy in the (neo)adjuvant setting (yes vs no).|||10.6|-3.2|0.1413
72382652|NCT02819518|144274030|SUPERIORITY||Difference in ORR (%) vs. Control|6.1||||0.0725|TWO_SIDED|95.0|-2.1|14.0|||Cochran-Mantel-Haenszel||Based on Miettinen \& Nurminen method stratified by chemotherapy on study (taxane vs gemcitabine/carboplatin), and prior treatment with same class of chemotherapy in the (neo)adjuvant setting (yes vs no).|||14.0|-2.1|0.0725
72382653|NCT02819518|144274031|SUPERIORITY||Difference in ORR(%) vs. Control|12.1||||0.0213|TWO_SIDED|95.0|0.4|23.4|||Cochran-Mantel-Haenszel||Based on Miettinen \& Nurminen method stratified by chemotherapy on study (taxane vs gemcitabine/carboplatin) and prior treatment with same class of chemotherapy in the (neo)adjuvant setting (yes vs no).|||23.4|0.4|0.0213
72382654|NCT02819518|144274035|SUPERIORITY||Difference in DCR (%) vs. control|4.7||||0.0966|TWO_SIDED|95.0|-2.4|11.8|||Cochran-Mantel-Haenszel||Based on Miettinen \& Nurminen method stratified by chemotherapy on study (taxane vs gemcitabine/carboplatin), tumor PD-L1 status (CPS ≥1 vs CPS \<1) and prior treatment with same class of chemotherapy in the (neo) adjuvant setting (yes vs no).|||11.8|-2.4|0.0966
72382655|NCT02819518|144274036|SUPERIORITY||Difference in DCR (%) vs. Control|5.0||||0.1164|TWO_SIDED|95.0|-3.2|13.1|||Cochran-Mantel-Haenszel||Based on Miettinen \& Nurminen method stratified by chemotherapy on study (taxane vs gemcitabine/carboplatin) and prior treatment with same class of chemotherapy in the (neo) adjuvant setting (yes vs no).|||13.1|-3.2|0.1164
72382656|NCT02819518|144274037|SUPERIORITY||Difference in DCR (%) vs. Control|10.8||||0.0327|TWO_SIDED|95.0|-0.7|22.3|||Cochran-Mantel-Haenszel||Based on Miettinen \& Nurminen method stratified by chemotherapy on study (taxane vs gemcitabine/carboplatin) and prior treatment with same class of chemotherapy in the (neo) adjuvant setting (yes vs no).|||22.3|-0.7|0.0327
72382657|NCT01505647|144274046|NON_INFERIORITY_OR_EQUIVALENCE|The GMT induced by ZOSTAVAX™ (AMP) vaccine is statistically non-inferior to that induced by the current process vaccine if the lower bound of the 95% confidence interval of the GMT ratio is \>0.67.|GMT Ratio|1.08|||<|0.001|TWO_SIDED|95.0|0.98|1.2||The threshold for statistical significance is 0.025 (1-sided). The P-value was not adjusted.|Longitudinal regression model|The analyzed GMT ratio, 95% confidence interval, and P-value were based on a longitudinal regression model adjusting for age and vaccination group||The hypothesis tested is that the GMT at Week 6 postvaccination with ZOSTAVAX™ (AMP) vaccine is non-inferior to that with the current process vaccine||1.20|0.98|<0.001
72382658|NCT01505647|144274047|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The threshold for statistical significance is 0.025 (1-sided). The P-value was not adjusted.|t-test, 1 sided|||The hypothesis tested was that ZOSTAVAX™ (AMP) induces an acceptable GMFR in VZV antibody titer from prevaccination to 6 weeks postvaccination||||<0.001
72382659|NCT06624449|144274054|SUPERIORITY||Mean Difference (Final Values)|0.09|||<|0.05|TWO_SIDED|95.0|||||t-test, 2 sided|||||||<0.05
72382660|NCT05098938|144274112|SUPERIORITY|||||||0.716|||||||Log Rank|||||||0.716
72382661|NCT05098938|144274113|SUPERIORITY|||||||0.102|||||||Chi-squared|||||||0.102
72382662|NCT05098938|144274114|SUPERIORITY|||||||0.712|||||||Chi-squared|||||||0.712
72557559|NCT00205777|144645437|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 6 in femoral neck BMD: P value was calculated using ANCOVA.||||<0.001
72557560|NCT00205777|144645437|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 12 in femoral neck BMD: P value was calculated using ANCOVA.||||<0.001
72382663|NCT05098938|144274115|SUPERIORITY|||||||0.575|||||||Log Rank|||||||0.575
72382664|NCT00518687|144274123|SUPERIORITY_OR_OTHER||Vaccine Efficacy (VE)|18.5||||0.584|TWO_SIDED|95.0|-48.6|55.8||A 1-sided p-value \<0.025 implies that the V710 vaccine efficacy is statistically significantly greater than 20%|Exact 1-sided binomial test||VE = 1 - Relative Risk of V710 compared with placebo|||55.8|-48.6|0.584
72382665|NCT00518687|144274124|SUPERIORITY_OR_OTHER||Estimated rate difference|0.0||||0.997|TWO_SIDED|95.0|-0.1|0.1|||Miettinen and Nurminen|||||0.1|-0.1|0.997
72434803|NCT01235949|144383120|NON_INFERIORITY|Criterion for evaluation of non-inferiority: The upper limit (UL) of the 2-sided 98.25% confidence interval (98.25% CI) (adjusted 1-sided alpha = 0.875%) of the difference between groups (NIBU minus DIBU), in terms of percentage of subjects with pneumococcal antibody concentrations ≥ 0.2 µg/mL, was lower than (\<) 10% for at least 7 out of the 10 pneumococcal serotypes.|Difference in percentages|2.73|||||TWO_SIDED|98.25|-5.3|11.04||||||At one month after primary immunization, the difference between groups (NIBU minus DIBU), in terms of percentage of subjects with pneumococcal antibody concentrations ≥ 0.2 µg/mL were calculated for anti-pneumococccal serotype 23F.||11.04|-5.3|
72434804|NCT01235949|144383121|NON_INFERIORITY|A statistically significant decrease in GMC was established if the UL of the two-sided 99.8% CI (adjusted one-sided alpha = 0.11364%) for the GMC ratios (IIBU over NIBU) was below (\<) 1 for at least one of the 10 vaccine pneumococcal serotypes.|GMC ratio|0.96|||||TWO_SIDED|99.8|0.71|1.29||||||At one month after primary immunization, ELISA Geometric Mean Concentration (GMC) ratios (IIBU over NIBU) were calculated for anti-pneumococcal serotype 1.||1.29|0.71|
72434805|NCT01235949|144383121|NON_INFERIORITY|A statistically significant decrease in GMC was established if the UL of the two-sided 99.8% CI (adjusted one-sided alpha = 0.11364%) for the GMC ratios (IIBU over NIBU) was below (\<) 1 for at least one of the 10 vaccine pneumococcal serotypes.|GMC ratio|1.02|||||TWO_SIDED|99.8|0.77|1.35||||||At one month after primary immunization, ELISA Geometric Mean Concentration (GMC) ratios (IIBU over NIBU) were calculated for anti-pneumococcal serotype 4.||1.35|0.77|
72434806|NCT01235949|144383121|NON_INFERIORITY|A statistically significant decrease in GMC was established if the UL of the two-sided 99.8% CI (adjusted one-sided alpha = 0.11364%) for the GMC ratios (IIBU over NIBU) was below (\<) 1 for at least one of the 10 vaccine pneumococcal serotypes.|GMC ratio|1.06|||||TWO_SIDED|99.8|0.8|1.41||||||At one month after primary immunization, ELISA Geometric Mean Concentration (GMC) ratios (IIBU over NIBU) were calculated for anti-pneumococcal serotype 5.||1.41|0.8|
72434807|NCT01235949|144383121|NON_INFERIORITY|A statistically significant decrease in GMC was established if the UL of the two-sided 99.8% CI (adjusted one-sided alpha = 0.11364%) for the GMC ratios (IIBU over NIBU) was below (\<) 1 for at least one of the 10 vaccine pneumococcal serotypes.|GMC ratio|1.12|||||TWO_SIDED|99.8|0.72|1.74||||||At one month after primary immunization, ELISA Geometric Mean Concentration (GMC) ratios (IIBU over NIBU) were calculated for anti-pneumococcal serotype 6B.||1.74|0.72|
72434808|NCT01235949|144383121|NON_INFERIORITY|A statistically significant decrease in GMC was established if the UL of the two-sided 99.8% CI (adjusted one-sided alpha = 0.11364%) for the GMC ratios (IIBU over NIBU) was below (\<) 1 for at least one of the 10 vaccine pneumococcal serotypes.|GMC ratio|1.04|||||TWO_SIDED|99.8|0.79|1.35||||||At one month after primary immunization, ELISA Geometric Mean Concentration (GMC) ratios (IIBU over NIBU) were calculated for anti-pneumococcal serotype 7F.||1.35|0.79|
72434809|NCT01235949|144383121|NON_INFERIORITY|A statistically significant decrease in GMC was established if the UL of the two-sided 99.8% CI (adjusted one-sided alpha = 0.11364%) for the GMC ratios (IIBU over NIBU) was below (\<) 1 for at least one of the 10 vaccine pneumococcal serotypes.|GMC ratio|0.96|||||TWO_SIDED|99.8|0.7|1.31||||||At one month after primary immunization, ELISA Geometric Mean Concentration (GMC) ratios (IIBU over NIBU) were calculated for anti-pneumococcal serotype 9V.||1.31|0.7|
72434810|NCT01235949|144383121|NON_INFERIORITY|A statistically significant decrease in GMC was established if the UL of the two-sided 99.8% CI (adjusted one-sided alpha = 0.11364%) for the GMC ratios (IIBU over NIBU) was below (\<) 1 for at least one of the 10 vaccine pneumococcal serotypes.|GMC ratio|1.0|||||TWO_SIDED|99.8|0.71|1.4||||||At one month after primary immunization, ELISA Geometric Mean Concentration (GMC) ratios (IIBU over NIBU) were calculated for anti-pneumococcal serotype 14.||1.4|0.71|
72494110|NCT03237065|144517206|SUPERIORITY||Mean Difference (Final Values)|1.22|||<|0.0001|TWO_SIDED|95.0|0.99|1.46|||Mixed model for repeated measures|||"Day 14~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||1.46|0.99|<0.0001
72494111|NCT03237065|144517206|SUPERIORITY||Mean Difference (Final Values)|1.24|||<|0.0001|TWO_SIDED|95.0|0.98|1.51|||Mixed model for repeated measures|||"Day 21~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||1.51|0.98|<0.0001
72494112|NCT03237065|144517206|SUPERIORITY||Mean Difference (Final Values)|1.17|||<|0.0001|TWO_SIDED|95.0|0.91|1.43|||Mixed model for repeated measures|||"Day 35~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||1.43|0.91|<0.0001
72494113|NCT03237065|144517207|SUPERIORITY||Mean Difference (Final Values)|13.99|||<|0.0001|TWO_SIDED|95.0|9.38|18.59|||Mixed model for repeated measures|||"Day 1~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||18.59|9.38|<0.0001
72557561|NCT00205777|144645437|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 18 in femoral neck BMD: P value was calculated using ANCOVA.||||<0.001
72557562|NCT00205777|144645437|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 24 in femoral neck BMD: P value was calculated using ANCOVA.||||<0.001
72618698|NCT01026038|144768108|SUPERIORITY_OR_OTHER||GMT ratio|0.3|||||TWO_SIDED|95.0|0.07|1.24||||||Serotype 23F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.24|0.07|
72434811|NCT01235949|144383121|NON_INFERIORITY|A statistically significant decrease in GMC was established if the UL of the two-sided 99.8% CI (adjusted one-sided alpha = 0.11364%) for the GMC ratios (IIBU over NIBU) was below (\<) 1 for at least one of the 10 vaccine pneumococcal serotypes.|GMC ratio|0.89|||||TWO_SIDED|99.8|0.6|1.31||||||At one month after primary immunization, ELISA Geometric Mean Concentration (GMC) ratios (IIBU over NIBU) were calculated for anti-pneumococcal serotype 18C.||1.31|0.6|
72434812|NCT01235949|144383121|NON_INFERIORITY|A statistically significant decrease in GMC was established if the UL of the two-sided 99.8% CI (adjusted one-sided alpha = 0.11364%) for the GMC ratios (IIBU over NIBU) was below (\<) 1 for at least one of the 10 vaccine pneumococcal serotypes.|GMC ratio|1.23|||||TWO_SIDED|99.8|0.87|1.75||||||At one month after primary immunization, ELISA Geometric Mean Concentration (GMC) ratios (IIBU over NIBU) were calculated for anti-pneumococcal serotype 19F.||1.75|0.87|
72494114|NCT03237065|144517207|SUPERIORITY||Mean Difference (Final Values)|15.84|||<|0.0001|TWO_SIDED|95.0|9.45|22.23|||Mixed model for repeated measures|||"Day 7~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||22.23|9.45|<0.0001
72494115|NCT03237065|144517207|SUPERIORITY||Mean Difference (Final Values)|21.66|||<|0.0001|TWO_SIDED|95.0|14.72|28.59|||Mixed model for repeated measures|||"Day 8~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||28.59|14.72|<0.0001
72494116|NCT03237065|144517207|SUPERIORITY||Mean Difference (Final Values)|36.17|||<|0.0001|TWO_SIDED|95.0|29.28|43.06|||Mixed model for repeated measures|||"Day 14~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||43.06|29.28|<0.0001
72494117|NCT03237065|144517207|SUPERIORITY||Mean Difference (Final Values)|37.86|||<|0.0001|TWO_SIDED|95.0|29.99|45.72|||Mixed model for repeated measures|||"Day 21~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||45.72|29.99|<0.0001
72494118|NCT03237065|144517207|SUPERIORITY||Mean Difference (Final Values)|34.53|||<|0.0001|TWO_SIDED|95.0|26.8|42.26|||Mixed model for repeated measures|||"Day 35~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||42.26|26.80|<0.0001
72494119|NCT03237065|144517209|SUPERIORITY||Mean Difference (Final Values)|-96.8|||<|0.0001|TWO_SIDED|95.0|-119.8|-73.8|||Mixed model for repeated measures|||"Day 1~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||-73.8|-119.8|<0.0001
72494120|NCT03237065|144517209|SUPERIORITY||Mean Difference (Final Values)|-15.7||||0.1064|TWO_SIDED|95.0|-34.9|3.4|||Mixed model for repeated measures|||"Day 7~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||3.4|-34.9|0.1064
72494121|NCT03237065|144517209|SUPERIORITY||Mean Difference (Final Values)|-251.7|||<|0.0001|TWO_SIDED|95.0|-307.2|-196.2|||Mixed model for repeated measures|||"Day 8~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||-196.2|-307.2|<0.0001
72494122|NCT03237065|144517209|SUPERIORITY||Mean Difference (Final Values)|-79.1|||<|0.0001|TWO_SIDED|95.0|-103.7|-54.5|||Mixed model for repeated measures|||"Day 14~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||-54.5|-103.7|<0.0001
72494123|NCT03237065|144517209|SUPERIORITY||Mean Difference (Final Values)|-61.8|||<|0.0001|TWO_SIDED|95.0|-83.0|-40.5|||Mixed model for repeated measures|||"Day 21~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||-40.5|-83.0|<0.0001
72557563|NCT00205777|144645437|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 36 in femoral neck BMD: P value was calculated using ANCOVA.||||<0.001
72618699|NCT01026038|144768108|SUPERIORITY_OR_OTHER||GMT ratio|0.3|||||TWO_SIDED|95.0|0.06|2.08||||||Serotype 23F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||2.08|0.06|
72434813|NCT01235949|144383121|NON_INFERIORITY|A statistically significant decrease in GMC was established if the UL of the two-sided 99.8% CI (adjusted one-sided alpha = 0.11364%) for the GMC ratios (IIBU over NIBU) was below (\<) 1 for at least one of the 10 vaccine pneumococcal serotypes.|GMC ratio|0.97|||||TWO_SIDED|99.8|0.66|1.44||||||At one month after primary immunization, ELISA Geometric Mean Concentration (GMC) ratios (IIBU over NIBU) were calculated for anti-pneumococcal serotype 23F.||1.44|0.66|
72434814|NCT01235949|144383121|NON_INFERIORITY|A statistically significant decrease in GMC was established if the UL of the two-sided 99.8% CI (adjusted one-sided alpha = 0.11364%) for the GMC ratios (DIBU over NIBU) was below (\<) 1 for at least one of the 10 vaccine pneumococcal serotypes.|GMC ratio|0.9|||||TWO_SIDED|99.8|0.67|1.21||||||At one month after primary immunization, ELISA Geometric Mean Concentration (GMC) ratios (DIBU over NIBU) were calculated for anti-pneumococcal serotype 1.||1.21|0.67|
72434815|NCT01235949|144383121|NON_INFERIORITY|A statistically significant decrease in GMC was established if the UL of the two-sided 99.8% CI (adjusted one-sided alpha = 0.11364%) for the GMC ratios (DIBU over NIBU) was below (\<) 1 for at least one of the 10 vaccine pneumococcal serotypes.|GMC ratio|1.0|||||TWO_SIDED|99.8|0.76|1.32||||||At one month after primary immunization, ELISA Geometric Mean Concentration (GMC) ratios (DIBU over NIBU) were calculated for anti-pneumococcal serotype 4.||1.32|0.76|
72434816|NCT01235949|144383121|NON_INFERIORITY|A statistically significant decrease in GMC was established if the UL of the two-sided 99.8% CI (adjusted one-sided alpha = 0.11364%) for the GMC ratios (DIBU over NIBU) was below (\<) 1 for at least one of the 10 vaccine pneumococcal serotypes.|GMC ratio|0.86|||||TWO_SIDED|99.8|0.66|1.14||||||At one month after primary immunization, ELISA Geometric Mean Concentration (GMC) ratios (DIBU over NIBU) were calculated for anti-pneumococcal serotype 5.||1.14|0.66|
72434817|NCT01235949|144383121|NON_INFERIORITY|A statistically significant decrease in GMC was established if the UL of the two-sided 99.8% CI (adjusted one-sided alpha = 0.11364%) for the GMC ratios (DIBU over NIBU) was below (\<) 1 for at least one of the 10 vaccine pneumococcal serotypes.|GMC ratio|1.28|||||TWO_SIDED|99.8|0.83|1.97||||||At one month after primary immunization, ELISA Geometric Mean Concentration (GMC) ratios (DIBU over NIBU) were calculated for anti-pneumococcal serotype 6B.||1.97|0.83|
72434818|NCT01235949|144383121|NON_INFERIORITY|A statistically significant decrease in GMC was established if the UL of the two-sided 99.8% CI (adjusted one-sided alpha = 0.11364%) for the GMC ratios (DIBU over NIBU) was below (\<) 1 for at least one of the 10 vaccine pneumococcal serotypes.|GMC ratio|1.02|||||TWO_SIDED|99.8|0.8|1.31||||||At one month after primary immunization, ELISA Geometric Mean Concentration (GMC) ratios (DIBU over NIBU) were calculated for anti-pneumococcal serotype 7F.||1.31|0.8|
72434819|NCT01235949|144383121|NON_INFERIORITY|A statistically significant decrease in GMC was established if the UL of the two-sided 99.8% CI (adjusted one-sided alpha = 0.11364%) for the GMC ratios (DIBU over NIBU) was below (\<) 1 for at least one of the 10 vaccine pneumococcal serotypes.|GMC ratio|0.92|||||TWO_SIDED|99.8|0.69|1.22||||||At one month after primary immunization, ELISA Geometric Mean Concentration (GMC) ratios (DIBU over NIBU) were calculated for anti-pneumococcal serotype 9V.||1.22|0.69|
72434820|NCT01235949|144383121|NON_INFERIORITY|A statistically significant decrease in GMC was established if the UL of the two-sided 99.8% CI (adjusted one-sided alpha = 0.11364%) for the GMC ratios (DIBU over NIBU) was below (\<) 1 for at least one of the 10 vaccine pneumococcal serotypes.|GMC ratio|0.95|||||TWO_SIDED|99.8|0.68|1.32||||||At one month after primary immunization, ELISA Geometric Mean Concentration (GMC) ratios (DIBU over NIBU) were calculated for anti-pneumococcal serotype 14.||1.32|0.68|
72434821|NCT01235949|144383121|NON_INFERIORITY|A statistically significant decrease in GMC was established if the UL of the two-sided 99.8% CI (adjusted one-sided alpha = 0.11364%) for the GMC ratios (DIBU over NIBU) was below (\<) 1 for at least one of the 10 vaccine pneumococcal serotypes.|GMC ratio|0.88|||||TWO_SIDED|99.8|0.6|1.27||||||At one month after primary immunization, ELISA Geometric Mean Concentration (GMC) ratios (DIBU over NIBU) were calculated for anti-pneumococcal serotype 18C.||1.27|0.6|
72434822|NCT01235949|144383121|NON_INFERIORITY|A statistically significant decrease in GMC was established if the UL of the two-sided 99.8% CI (adjusted one-sided alpha = 0.11364%) for the GMC ratios (DIBU over NIBU) was below (\<) 1 for at least one of the 10 vaccine pneumococcal serotypes.|GMC ratio|1.02|||||TWO_SIDED|99.8|0.72|1.44||||||At one month after primary immunization, ELISA Geometric Mean Concentration (GMC) ratios (DIBU over NIBU) were calculated for anti-pneumococcal serotype 19F.||1.44|0.72|
72434823|NCT01235949|144383121|NON_INFERIORITY|A statistically significant decrease in GMC was established if the UL of the two-sided 99.8% CI (adjusted one-sided alpha = 0.11364%) for the GMC ratios (DIBU over NIBU) was below (\<) 1 for at least one of the 10 vaccine pneumococcal serotypes.|GMC ratio|0.86|||||TWO_SIDED|99.8|0.58|1.27||||||At one month after primary immunization, ELISA Geometric Mean Concentration (GMC) ratios (DIBU over NIBU) were calculated for anti-pneumococcal serotype 23F.||1.27|0.58|
72494124|NCT03237065|144517209|SUPERIORITY||Mean Difference (Final Values)|-18.0||||0.0039|TWO_SIDED|95.0|-30.1|-5.9|||Mixed model for repeated measures|||"Day 35~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||-5.9|-30.1|0.0039
72494125|NCT03237065|144517210|SUPERIORITY||Mean Difference (Final Values)|-57.5||||0.1243|TWO_SIDED|95.0|-131.1|16.1|||Mixed model for repeated measures|||"Day 1~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||16.1|-131.1|0.1243
72494126|NCT03237065|144517210|SUPERIORITY||Mean Difference (Final Values)|20.7||||0.5547|TWO_SIDED|95.0|-49.7|91.0|||Mixed model for repeated measures|||"Day 7~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||91.0|-49.7|0.5547
72557564|NCT00205777|144645437|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 6 in femoral trochanter BMD: P value was calculated using ANCOVA.||||<0.001
72557565|NCT00205777|144645437|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 12 in femoral trochanter BMD: P value was calculated using ANCOVA.||||<0.001
72557566|NCT00205777|144645437|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 18 in femoral trochanter BMD: P value was calculated using ANCOVA.||||<0.001
72557567|NCT00205777|144645437|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 24 in femoral trochanter BMD: P value was calculated using ANCOVA.||||<0.001
72557568|NCT00205777|144645437|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 36 in femoral trochanter BMD: P value was calculated using ANCOVA.||||<0.001
72557569|NCT00205777|144645437|SUPERIORITY_OR_OTHER|||||||0.01|TWO_SIDED||||||ANCOVA|||Percent change at Month 6 in femoral trochanter BMD: P value was calculated using ANCOVA.||||0.01
72382666|NCT00518687|144274125|SUPERIORITY_OR_OTHER||Vaccine Efficacy (VE)|12.9||||0.347|TWO_SIDED|95.0|-50.8|50.0||A 1-sided p-value \<0.025 implies that the V710 vaccine efficacy is statistically significant|Exact 1-sided binomial test||VE = 1 - Relative Risk of V710 compared with placebo|||50.0|-50.8|0.347
72382667|NCT00518687|144274126|SUPERIORITY_OR_OTHER||Vaccine Efficacy (VE)|29.3||||0.032|TWO_SIDED|95.0|-1.8|51.2||A 1-sided p-value \<0.025 implies that the V710 vaccine efficacy is statistically significant|Exact 1-sided binomial test||VE = 1 - Relative Risk of V710 compared with placebo|||51.2|-1.8|0.032
72382668|NCT05108922|144274127|SUPERIORITY||Odds Ratio (OR)|29.26|||<|0.001|TWO_SIDED|95.0|5.3|100.0|||Regression, Logistic|||Analysis was based on logistic regression model with treatment, Apolipoprotein (ApoE) ε4 Carrier Status, baseline amyloid Level, baseline age as factors.||100.0|5.30|<0.001
72382669|NCT05108922|144274128|SUPERIORITY||Odds Ratio (OR)|15.18||||0.008|TWO_SIDED|95.0|2.04|100.0|||Regression, Logistic|||Analysis was based on logistic regression model with treatment, ApoE ε4 Carrier Status, baseline amyloid Level, baseline age as factors.||100.0|2.04|0.008
72382670|NCT05108922|144274129|SUPERIORITY||LS Mean difference (Final Values)|-45.691|STANDARD_ERROR_OF_MEAN|4.6132|<|0.001|TWO_SIDED|95.0|-54.84|-36.54||Analysis between treatment group comparison p-value using analysis of covariance (ANCOVA) model for endpoint measures: Change (CHG) = Baseline + ApoE ε4 Carrier Status + Baseline Age + Treatment|ANCOVA|||||-36.54|-54.84|<0.001
72382671|NCT05108922|144274130|SUPERIORITY||LS Mean difference (Final Values)|-48.213|STANDARD_ERROR_OF_MEAN|4.9276|<|0.001|TWO_SIDED|95.0|-57.99|-38.44||Analysis between treatment group comparison p-value using ANCOVA model for endpoint measures: Percent change (PCHG) = Baseline + ApoE ε4 Carrier Status + Baseline Age + Treatment|ANCOVA|||||-38.44|-57.99|<0.001
72382672|NCT05108922|144274131|SUPERIORITY||LS Mean difference (Final Values)|-40.252|STANDARD_ERROR_OF_MEAN|10.551|<|0.001|TWO_SIDED|95.0|-61.87|-18.64||Analysis between treatment group comparison p-value using ANCOVA model for endpoint measures: CHG = Baseline + ApoE ε4 Carrier Status + Baseline Age + Treatment|ANCOVA|||||-18.64|-61.87|<0.001
72382673|NCT05108922|144274132|SUPERIORITY||LS Mean difference (Final Values)|-23.97|STANDARD_ERROR_OF_MEAN|4.231|<|0.001|TWO_SIDED|95.0|-32.35|-15.6||Analysis between treatment group comparison p-value using mixed model for repeated measures (MMRM) model for Treatment + Visit + Treatment\*Visit + ApoE4 Carrier Status + Baseline Brain Amyloid Level + Baseline Age.|Mixed Models Analysis|||||-15.60|-32.35|<0.001
72382674|NCT05108922|144274133|SUPERIORITY||LS Mean difference (Final Values)|-25.82|STANDARD_ERROR_OF_MEAN|4.381|<|0.001|TWO_SIDED|95.0|-34.49|-17.15||Analysis between treatment group comparison p-value using MMRM model for Treatment + Visit + Treatment\*Visit + ApoE4 Carrier Status + Baseline Brain Amyloid Level + Baseline Age.|Mixed Models Analysis|||||-17.15|-34.49|<0.001
72434824|NCT01235949|144383122|NON_INFERIORITY|A statistically significant decrease in GMC was established if the UL of the two-sided 99.8% CI (adjusted one-sided alpha = 0.11364%) for the GMC ratios (IIBU over NIBU) was below (\<) 1 for protein D.|GMC ratio|0.94|||||TWO_SIDED|99.8|0.69|1.28||||||At one month after primary immunization, ELISA Geometric Mean Concentration (GMC) ratios (IIBU over NIBU) were calculated for anti-Protein D (anti-PD) antibody.||1.28|0.69|
72434825|NCT01235949|144383122|NON_INFERIORITY|A statistically significant decrease in GMC was established if the UL of the two-sided 99.8% CI (adjusted one-sided alpha = 0.11364%) for the GMC ratios (DIBU over NIBU) was below (\<) 1 for protein D.|GMC ratio|0.87|||||TWO_SIDED|99.8|0.64|1.17||||||At one month after primary immunization, ELISA Geometric Mean Concentration (GMC) ratios (DIBU over NIBU) were calculated for anti-Protein D (anti-PD) antibody.||1.17|0.64|
72434826|NCT04173572|144383145|OTHER|Single group mean difference between baseline and post-treatment assessments.|Mean Difference (Net)|-13.47|STANDARD_DEVIATION|48.09|||TWO_SIDED|||||||||Posttreatment - Baseline: 10 participants analyzed (had data at both time points)||||
72434827|NCT04173572|144383145|OTHER|Single group mean difference between baseline and post-treatment assessments.|Mean Difference (Net)|1.7|STANDARD_DEVIATION|52.743|||TWO_SIDED|||||||||Posttreatment - Baseline: 9 participants analyzed (had data at both time points)||||
72434828|NCT04173572|144383146|OTHER|Single group mean difference between baseline and post-treatment assessments.|Mean Difference (Net)|22.133|STANDARD_DEVIATION|79.938|||TWO_SIDED|||||||||Posttreatment - Baseline: 15 participants analyzed (had data at both time points)||||
72557570|NCT00205777|144645437|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED||||||ANCOVA|||Percent change at Month 12 in femoral trochanter BMD: P value was calculated using ANCOVA.||||0.002
72557571|NCT00205777|144645437|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 18 in femoral trochanter BMD: P value was calculated using ANCOVA.||||<0.001
72557572|NCT00205777|144645437|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 24 in femoral trochanter BMD: P value was calculated using ANCOVA.||||<0.001
72557573|NCT00205777|144645437|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 36 in femoral trochanter BMD: P value was calculated using ANCOVA.||||<0.001
72557574|NCT00205777|144645437|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 6 in femoral trochanter BMD: P value was calculated using ANCOVA.||||<0.001
72557575|NCT00205777|144645437|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 12 in femoral trochanter BMD: P value was calculated using ANCOVA.||||<0.001
72557576|NCT00205777|144645437|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 18 in femoral trochanter BMD: P value was calculated using ANCOVA.||||<0.001
72557577|NCT00205777|144645437|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 24 in femoral trochanter BMD: P value was calculated using ANCOVA.||||<0.001
72382675|NCT05108922|144274134|SUPERIORITY||Odds Ratio (OR)|8.38|||<|0.001|TWO_SIDED|95.0|3.37|20.81||Analysis was based on logistic regression model with 1 (Screening) value, ApoE4 Status, Age, Treatment, Time, and Treatment-by-time interaction as factors. Variance-Covariance structure = Unstructured|Regression, Logistic|||||20.81|3.37|<0.001
72382676|NCT05108922|144274135|SUPERIORITY||Odds Ratio (OR)|37.73|||<|0.001|TWO_SIDED|95.0|5.71|99.99||Analysis between treatment group comparison p-value using MMRM model for Treatment + Visit + Treatment\*Visit + ApoE4 Carrier Status + Baseline Brain Amyloid Level + Baseline Age.|Regression, Logistic|||||99.99|5.71|<.001
72382677|NCT05108922|144274136|SUPERIORITY||LS Mean difference (Final Values)|-26.75|STANDARD_ERROR_OF_MEAN|6.479|<|0.001|TWO_SIDED|95.0|-39.78|-13.73||Analysis between treatment group comparison p-value using MMRM model for Treatment + Visit + Treatment\*Visit + ApoE4 Carrier Status + Baseline Brain Amyloid Level + Baseline Age.|Mixed Models Analysis|||||-13.73|-39.78|<0.001
72382678|NCT05108922|144274137|SUPERIORITY||LS Mean difference (Final Values)|-7.931|STANDARD_ERROR_OF_MEAN|4.1187||0.0558|TWO_SIDED|95.0|-16.06|0.199||Analysis between treatment group comparison p-value using MMRM model for Treatment + Visit + Treatment\*Visit + ApoE4 Carrier Status + Baseline Brain Amyloid Level + Baseline Age.|Mixed Models Analysis|||||0.199|-16.060|0.0558
72382679|NCT05108922|144274138|NON_INFERIORITY|Non-inferiority margin of interest: 5 Centiloids|LS Mean difference (Final Values)|-7.931|STANDARD_ERROR_OF_MEAN|4.1187|||TWO_SIDED|95.0|-16.06|0.199||Analysis between treatment group comparison p-value using MMRM model for Treatment + Visit + Treatment\*Visit + ApoE4 Carrier Status + Baseline Brain Amyloid Level + Baseline Age.|Mixed Models Analysis|||||0.199|-16.060|
72382680|NCT05108922|144274139|SUPERIORITY||LS Mean difference (Final Values)|-12.04|STANDARD_ERROR_OF_MEAN|4.12||0.004|TWO_SIDED|95.0|-20.19|-3.88||Analysis between treatment group comparison p-value using MMRM model for Treatment + Visit + Treatment\*Visit + ApoE4 Carrier Status + Baseline Brain Amyloid Level + Baseline Age.|Mixed Models Analysis|||||-3.88|-20.19|0.004
72382681|NCT05108922|144274140|SUPERIORITY||||||<|0.001|||||||Log Rank|||||||<0.001
72382682|NCT05108922|144274141|SUPERIORITY||LS Mean difference (Final Values)|-13.45|STANDARD_ERROR_OF_MEAN|4.3||0.002|TWO_SIDED|95.0|-21.96|-4.93||Analysis between treatment group comparison p-value using MMRM model for Treatment + Visit + Treatment\*Visit + ApoE4 Carrier Status + Baseline Brain Amyloid Level + Baseline Age.|Mixed Models Analysis|||||-4.93|-21.96|0.002
72382683|NCT05108922|144274142|SUPERIORITY||Odds Ratio (OR)|4.68|||<|0.001|TWO_SIDED|95.0|1.93|11.34||Analysis was based on logistic regression model with 1 (Screening) value, ApoE4 Status, Age, Treatment, Time, and Treatment-by-time interaction as factors. Variance-Covariance structure = Unstructured.|Regression, Logistic|||||11.34|1.93|<0.001
72382684|NCT05108922|144274143|SUPERIORITY||Odds Ratio (OR)|6.34||||0.022|TWO_SIDED|95.0|1.32|30.54||Analysis was based on logistic regression model with 1 (Screening) value, ApoE4 Status, Age, Treatment, Time, and Treatment-by-time interaction as factors. Variance-Covariance structure = Unstructured.|Regression, Logistic|||||30.54|1.32|0.022
72382685|NCT05108922|144274144|SUPERIORITY||LS Mean difference (Final Values)|-14.33|STANDARD_ERROR_OF_MEAN|6.333||0.028|TWO_SIDED|95.0|-27.07|-1.59||Analysis between treatment group comparison p-value using MMRM model for Treatment + Visit + Treatment\*Visit + ApoE4 Carrier Status + Baseline Brain Amyloid Level + Baseline Age.|Mixed Models Analysis|||||-1.59|-27.07|0.028
72382686|NCT05108922|144274145|NON_INFERIORITY|Non-inferiority margin of interest: 5 Centiloids.|LS Mean difference (Final Values)|7.831|STANDARD_ERROR_OF_MEAN|4.087|||TWO_SIDED|95.0|-0.226|15.889||Analysis between treatment group comparison p-value using MMRM model for Treatment + Visit + Treatment\*Visit + ApoE4 Carrier Status + Baseline Brain Amyloid Level + Baseline Age.|Mixed Models Analysis|||||15.889|-0.226|
72382687|NCT00704912|144274146|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|2.5||||0.06|TWO_SIDED|95.0|1.0|6.6|||Log-binomial model|||||6.6|1.0|0.06
72382688|NCT00704912|144274146|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|2.3||||0.08|TWO_SIDED|95.0|0.9|6.1|||Log-binomial model|||||6.1|0.9|0.08
72382689|NCT00704912|144274146|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.1||||0.82|TWO_SIDED|95.0|0.5|2.1|||Log-binomial model|||||2.1|0.5|0.82
72382690|NCT00704912|144274147|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.3||||0.06|TWO_SIDED|95.0|1.0|1.7|||Log-binomial model|||||1.7|1.0|0.06
72382691|NCT00704912|144274147|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.5||||0.002|TWO_SIDED|95.0|1.1|1.9|||Log-binomial model|||||1.9|1.1|0.002
72382692|NCT00704912|144274147|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.9||||0.28|TWO_SIDED|95.0|0.7|1.1|||Log-binomial model|||||1.1|0.7|0.28
72434829|NCT04173572|144383146|OTHER|Single group mean difference between baseline and post-treatment assessments.|Mean Difference (Net)|7.8|STANDARD_DEVIATION|99.645|||TWO_SIDED|||||||||Posttreatment - Baseline: 15 participants analyzed (had data at both time points)||||
72434830|NCT04173572|144383147|OTHER|Single group mean difference between baseline and post-treatment assessments.|Mean Difference (Net)|13.642|STANDARD_DEVIATION|4213.837|||TWO_SIDED|||||||||Posttreatment - Baseline: 14 participants analyzed (had data at both time points)||||
72382693|NCT00704912|144274148|SUPERIORITY_OR_OTHER||Difference in Mean Change|-5.0|||<|0.0001|TWO_SIDED|95.0|-6.3|-3.8|||Mixed Models Analysis||Lifestyle vs. OCP|||-3.8|-6.3|<.0001
72382694|NCT00704912|144274148|SUPERIORITY_OR_OTHER||Difference in Mean Change|-5.0|||<|0.0001|TWO_SIDED|95.0|-6.2|-3.7|||Mixed Models Analysis||Combined vs. OCP|||-3.7|-6.2|<.0001
72382695|NCT00704912|144274148|SUPERIORITY_OR_OTHER||Difference in Mean Change|-0.1||||0.92|TWO_SIDED|95.0|-1.3|1.2|||Mixed Models Analysis||Lifestyle vs. Combined|||1.2|-1.3|0.92
72382696|NCT00704912|144274149|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.2||||0.6|TWO_SIDED|95.0|0.6|2.2|||GEE||End of intervention compared to baseline.|Comparing change in prevalence of metabolic syndrome from baseline to the end of intervention.||2.2|0.6|0.60
72382697|NCT00704912|144274149|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.5||||0.001|TWO_SIDED|95.0|1.4|4.3|||GEE||End of intervention compared to baseline|Comparing change in prevalence of metabolic syndrome from baseline to the end of intervention.||4.3|1.4|0.001
72382698|NCT00704912|144274149|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.7||||0.18|TWO_SIDED|95.0|0.4|1.2|||GEE||End of intervention compared to baseline|Comparing change in prevalence of metabolic syndrome from baseline to the end of intervention.||1.2|0.4|0.18
72382699|NCT00704912|144274149|SUPERIORITY_OR_OTHER|||||||0.08|TWO_SIDED||||||GEE|||||||0.08
72382700|NCT00704912|144274149|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED||||||GEE|||||||0.001
72382701|NCT00704912|144274149|SUPERIORITY_OR_OTHER|||||||0.22|TWO_SIDED||||||GEE|||||||0.22
72382702|NCT00537238|144274182|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the difference in proportion (Pregabalin - Levetiracetam) was greater than -0.12.|Difference in Proportion|0.0|||||TWO_SIDED|90.0|-0.08|0.09||||||||0.09|-0.08|
72382703|NCT00537238|144274183|SUPERIORITY_OR_OTHER_LEGACY||Median difference|4.1||||0.3571|TWO_SIDED|95.0|-2.6|10.9|||Ranked ANCOVA|||Rank analysis of covariance (ANCOVA) model was used to derive p-value with treatment as main effect and cluster as cofactor, percent change in 28-day seizure counts between baseline and treatment periods as dependent variable. Median differences and 95% confidence interval (CI) were based on Hodges-Lehmann estimation.||10.9|-2.6|0.3571
72382704|NCT00537238|144274185|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0822|TWO_SIDED||||||Fisher Exact|||All partial seizure: p-value was calculated from the 2-sided Fisher's exact test.||||0.0822
72382705|NCT00537238|144274185|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9175|TWO_SIDED||||||Fisher Exact|||Simple partial seizure: p-value was calculated from the 2-sided Fisher's exact test.||||0.9175
72382706|NCT00537238|144274185|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0483|TWO_SIDED||||||Fisher Exact|||Complex partial seizure: p-value was calculated from the 2-sided Fisher's exact test.||||0.0483
72382707|NCT00537238|144274185|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7139|TWO_SIDED||||||Fisher Exact|||SGTC seizure: p-value was calculated from the 2-sided Fisher's exact test.||||0.7139
72434831|NCT04173572|144383147|OTHER|Single group mean difference between baseline and post-treatment assessments.|Mean Difference (Net)|-483.4|STANDARD_DEVIATION|2497.312|||TWO_SIDED|||||||||Posttreatment - Baseline: 15 participants analyzed (had data at both time points)||||
72434832|NCT04173572|144383148|OTHER|Single group mean difference between baseline and post-treatment assessments.|Mean Difference (Net)|-0.8|STANDARD_DEVIATION|4.229|||TWO_SIDED|||||||||Posttreatment - Baseline: 15 participants analyzed (had data at both time points)||||
72434833|NCT04173572|144383148|OTHER|Single group mean difference between baseline and post-treatment assessments.|Mean Difference (Net)|1.563|STANDARD_DEVIATION|8.695|||TWO_SIDED|||||||||Posttreatment - Baseline: 16 participants analyzed (had data at both time points)||||
72434834|NCT04173572|144383149|OTHER|Single group mean difference between baseline and post-treatment assessments.|Median Difference (Net)|-9.333|STANDARD_DEVIATION|14.166|||TWO_SIDED|||||||||Posttreatment - Baseline: 15 participants analyzed (had data at both time points)||||
72434835|NCT04173572|144383149|OTHER|Single group mean difference between baseline and post-treatment assessments.|Median Difference (Net)|0.625|STANDARD_DEVIATION|9.664|||TWO_SIDED|||||||||Posttreatment - Baseline: 16 participants analyzed (had data at both time points)||||
72382708|NCT00537238|144274186|SUPERIORITY_OR_OTHER_LEGACY||Least squares (LS) mean difference|1.17|STANDARD_ERROR_OF_MEAN|0.78||0.1334|TWO_SIDED|95.0|-0.36|2.69|||ANCOVA|||Baseline, total BPRS score: ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and combined center, and for post-baseline assessments baseline was included as a covariate.||2.69|-0.36|0.1334
72382709|NCT00537238|144274186|SUPERIORITY_OR_OTHER_LEGACY||LS mean differences|0.17|STANDARD_ERROR_OF_MEAN|0.18||0.3551|TWO_SIDED|95.0|-0.19|0.52|||ANCOVA|||Baseline, core BPRS score: ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and combined center, and for post-baseline assessments baseline was included as a covariate.||0.52|-0.19|0.3551
72382710|NCT00537238|144274186|SUPERIORITY_OR_OTHER_LEGACY||LS mean differences|-0.46|STANDARD_ERROR_OF_MEAN|0.5||0.3638|TWO_SIDED|95.0|-1.45|0.53|||ANCOVA|||Change at Week 7, total BPRS score: ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and combined center, and for post-baseline assessments baseline was included as a covariate.||0.53|-1.45|0.3638
72382711|NCT00537238|144274186|SUPERIORITY_OR_OTHER_LEGACY||LS mean differences|-0.12|STANDARD_ERROR_OF_MEAN|0.11||0.2457|TWO_SIDED|95.0|-0.34|0.09|||ANCOVA|||Change at Week 7, core BPRS score: ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and combined center, and for post-baseline assessments baseline was included as a covariate.||0.09|-0.34|0.2457
72382712|NCT00537238|144274186|SUPERIORITY_OR_OTHER_LEGACY||LS mean differences|-0.23|STANDARD_ERROR_OF_MEAN|0.53||0.664|TWO_SIDED|95.0|-1.26|0.81|||ANCOVA|||Change at Week 10, total BPRS score: ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and combined center, and for post-baseline assessments baseline was included as a covariate.||0.81|-1.26|0.6640
72382713|NCT00537238|144274186|SUPERIORITY_OR_OTHER_LEGACY||LS mean differences|-0.06|STANDARD_ERROR_OF_MEAN|0.12||0.595|TWO_SIDED|95.0|-0.3|0.17|||ANCOVA|||Change at Week 10, core BPRS score: ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and combined center, and for post-baseline assessments baseline was included as a covariate.||0.17|-0.30|0.5950
72382714|NCT00537238|144274186|SUPERIORITY_OR_OTHER_LEGACY||LS mean differences|-0.31|STANDARD_ERROR_OF_MEAN|0.55||0.5701|TWO_SIDED|95.0|-1.38|0.76|||ANCOVA|||Change at Week 13, total BPRS score: ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and combined center, and for post-baseline assessments baseline was included as a covariate.||0.76|-1.38|0.5701
72557578|NCT00205777|144645437|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 36 in femoral trochanter BMD: P value was calculated using ANCOVA.||||<0.001
72434836|NCT04173572|144383150|OTHER|Single group mean difference between baseline and post-treatment assessments.|Mean Difference (Net)|-0.392|STANDARD_DEVIATION|1.148|||TWO_SIDED|||||||||Posttreatment - Baseline: 13 participants analyzed (had data at both time points)||||
72434837|NCT04173572|144383150|OTHER|Single group mean difference between baseline and post-treatment assessments.|Mean Difference (Net)|0.113|STANDARD_DEVIATION|1.401|||TWO_SIDED|||||||||Posttreatment - Baseline: 15 participants analyzed (had data at both time points)||||
72434838|NCT04173572|144383151|OTHER|Single group mean difference between baseline and post-treatment assessments.|Mean Difference (Net)|2.2|STANDARD_DEVIATION|20.11|||TWO_SIDED|||||||||Posttreatment - Baseline: 15 participants analyzed (had data at both time points)||||
72434839|NCT04173572|144383151|OTHER|Single group mean difference between baseline and post-treatment assessments.|Mean Difference (Net)|0.49|STANDARD_DEVIATION|8.91|||TWO_SIDED|||||||||Posttreatment - Baseline: 15 participants analyzed (had data at both time points)||||
72557579|NCT00205777|144645437|SUPERIORITY_OR_OTHER|||||||0.048|TWO_SIDED||||||ANCOVA|||Percent change at Month 6 in femoral trochanter BMD: P value was calculated using ANCOVA.||||0.048
72557580|NCT00205777|144645437|SUPERIORITY_OR_OTHER|||||||0.038|TWO_SIDED||||||ANCOVA|||Percent change at Month 12 in femoral trochanter BMD: P value was calculated using ANCOVA.||||0.038
72557581|NCT00205777|144645437|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 18 in femoral trochanter BMD: P value was calculated using ANCOVA.||||<0.001
72557582|NCT00205777|144645437|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 24 in femoral trochanter BMD: P value was calculated using ANCOVA.||||<0.001
72557583|NCT00205777|144645437|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 36 in femoral trochanter BMD: P value was calculated using ANCOVA.||||<0.001
72434840|NCT04173572|144383152|OTHER|Single group mean difference between baseline and post-treatment assessments.|Mean Difference (Net)|-0.39|STANDARD_DEVIATION|4.67|||TWO_SIDED|||||||||Posttreatment - Baseline: 11 participants analyzed (had data at both time points)||||
72382715|NCT00537238|144274186|SUPERIORITY_OR_OTHER_LEGACY||LS mean differences|-0.12|STANDARD_ERROR_OF_MEAN|0.1||0.2452|TWO_SIDED|95.0|-0.33|0.08|||ANCOVA|||Change at Week 13, core BPRS score: ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and combined center, and for post-baseline assessments baseline was included as a covariate.||0.08|-0.33|0.2452
72382716|NCT00537238|144274186|SUPERIORITY_OR_OTHER_LEGACY||LS mean differences|-0.77|STANDARD_ERROR_OF_MEAN|0.56||0.1697|TWO_SIDED|95.0|-1.88|0.33|||ANCOVA|||Change at Week 16, total BPRS score: ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and combined center, and for post-baseline assessments baseline was included as a covariate.||0.33|-1.88|0.1697
72382717|NCT00537238|144274186|SUPERIORITY_OR_OTHER_LEGACY||LS mean differences|-0.14|STANDARD_ERROR_OF_MEAN|0.11||0.2283|TWO_SIDED|95.0|-0.36|0.09|||ANCOVA|||Change at Week 16, core BPRS score: ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and combined center, and for post-baseline assessments baseline was included as a covariate.||0.09|-0.36|0.2283
72382718|NCT00537238|144274186|SUPERIORITY_OR_OTHER_LEGACY||LS mean differences|-1.35|STANDARD_ERROR_OF_MEAN|0.61||0.0262|TWO_SIDED|95.0|-2.54|-0.16|||ANCOVA|||Change at Follow-up, total BPRS score: ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and combined center, and for post-baseline assessments baseline was included as a covariate.||-0.16|-2.54|0.0262
72382719|NCT00537238|144274186|SUPERIORITY_OR_OTHER_LEGACY||LS mean differences|-0.26|STANDARD_ERROR_OF_MEAN|0.13||0.0495|TWO_SIDED|95.0|-0.52|0.0|||ANCOVA|||Change at Follow-up, core BPRS score: ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and combined center, and for post-baseline assessments baseline was included as a covariate.||0.00|-0.52|0.0495
72382720|NCT00537238|144274187|SUPERIORITY_OR_OTHER_LEGACY||LS mean differences|-0.09|STANDARD_ERROR_OF_MEAN|0.37||0.8084|TWO_SIDED|95.0|-0.82|0.64|||ANCOVA|||Baseline, HADS-A: ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and combined center, and for post-baseline assessments baseline was included as a covariate.||0.64|-0.82|0.8084
72382721|NCT00537238|144274187|SUPERIORITY_OR_OTHER_LEGACY||LS mean differences|0.22|STANDARD_ERROR_OF_MEAN|0.35||0.5263|TWO_SIDED|95.0|-0.47|0.91|||ANCOVA|||Baseline, HADS-D: ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and combined center, and for post-baseline assessments baseline was included as a covariate.||0.91|-0.47|0.5263
72434841|NCT04173572|144383152|OTHER|Single group mean difference between baseline and post-treatment assessments.|Mean Difference (Net)|3.43|STANDARD_DEVIATION|9.4|||TWO_SIDED|||||||||Posttreatment - Baseline: 11 participants analyzed (had data at both time points)||||
72557584|NCT00205777|144645437|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 6 in femoral trochanter BMD: P value was calculated using ANCOVA.||||<0.001
72557585|NCT00205777|144645437|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 12 in femoral trochanter BMD: P value was calculated using ANCOVA.||||<0.001
72618700|NCT01026038|144768108|SUPERIORITY_OR_OTHER||GMT ratio|1.3|||||TWO_SIDED|95.0|0.79|1.97||||||Serotype 1: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||1.97|0.79|
72382722|NCT00537238|144274187|SUPERIORITY_OR_OTHER_LEGACY||LS mean differences|0.25|STANDARD_ERROR_OF_MEAN|0.3||0.4008|TWO_SIDED|95.0|-0.34|0.85|||ANCOVA|||Week 16, HADS-A: ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and combined center, and for post-baseline assessments baseline was included as a covariate.||0.85|-0.34|0.4008
72434842|NCT04173572|144383153|OTHER|Single group mean difference between baseline and post-treatment assessments.|Mean Difference (Net)|-3.667|STANDARD_DEVIATION|9.067|||TWO_SIDED|||||||||Posttreatment - Baseline: 15 participants analyzed (had data at both time points)||||
72434843|NCT04173572|144383153|OTHER|Single group mean difference between baseline and post-treatment assessments.|Mean Difference (Net)|-2.071|STANDARD_DEVIATION|12.25|||TWO_SIDED|||||||||Posttreatment - Baseline: 14 participants analyzed (had data at both time points)||||
72557586|NCT00205777|144645437|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 18 in femoral trochanter BMD: P value was calculated using ANCOVA.||||<0.001
72557587|NCT00205777|144645437|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 24 in femoral trochanter BMD: P value was calculated using ANCOVA.||||<0.001
72557588|NCT00205777|144645437|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 36 in femoral trochanter BMD: P value was calculated using ANCOVA.||||<0.001
72557589|NCT00205777|144645438|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 48 in lumbar spine BMD: P value was calculated using ANCOVA.||||<0.001
72557590|NCT00205777|144645438|SUPERIORITY_OR_OTHER|||||||0.01|TWO_SIDED||||||ANCOVA|||Percent change at Month 60 in lumbar spine BMD: P value was calculated using ANCOVA.||||0.010
72557591|NCT00205777|144645438|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 48 in lumbar spine BMD: P value was calculated using ANCOVA.||||<0.001
72557592|NCT00205777|144645438|SUPERIORITY_OR_OTHER|||||||0.023|TWO_SIDED||||||ANCOVA|||Percent change at Month 60 in lumbar spine BMD: P value was calculated using ANCOVA.||||0.023
72557593|NCT00205777|144645438|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 48 in total hip BMD: P value was calculated using ANCOVA.||||<0.001
72557594|NCT00205777|144645438|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 60 in total hip BMD: P value was calculated using ANCOVA.||||<0.001
72557595|NCT00205777|144645438|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 48 in total hip BMD: P value was calculated using ANCOVA.||||<0.001
72557596|NCT00205777|144645438|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 60 in total hip BMD: P value was calculated using ANCOVA.||||<0.001
72557597|NCT00205777|144645438|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 48 in femoral neck BMD: P value was calculated using ANCOVA.||||<0.001
72557598|NCT00205777|144645438|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 60 in femoral neck BMD: P value was calculated using ANCOVA.||||<0.001
72557599|NCT00205777|144645438|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 48 in femoral neck BMD: P value was calculated using ANCOVA.||||<0.001
72557600|NCT00205777|144645438|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 60 in femoral neck BMD: P value was calculated using ANCOVA.||||<0.001
72557601|NCT00205777|144645438|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 48 in femoral trochanter BMD: P value was calculated using ANCOVA.||||<0.001
72557602|NCT00205777|144645438|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 60 in femoral trochanter BMD: P value was calculated using ANCOVA.||||<0.001
72557603|NCT00205777|144645438|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 48 in femoral trochanter BMD: P value was calculated using ANCOVA.||||<0.001
72382723|NCT00537238|144274187|SUPERIORITY_OR_OTHER_LEGACY||LS mean differences|-0.01|STANDARD_ERROR_OF_MEAN|0.3||0.9749|TWO_SIDED|95.0|-0.61|0.59|||ANCOVA|||Week 16, HADS-D: ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and combined center, and for post-baseline assessments baseline was included as a covariate.||0.59|-0.61|0.9749
72494127|NCT03237065|144517210|SUPERIORITY||Mean Difference (Final Values)|-155.7||||0.0005|TWO_SIDED|95.0|-234.7|-76.6|||Mixed model for repeated measures|||"Day 8~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||-76.6|-234.7|0.0005
72557604|NCT00205777|144645438|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 60 in femoral trochanter BMD: P value was calculated using ANCOVA.||||<0.001
72382724|NCT00537238|144274188|SUPERIORITY_OR_OTHER_LEGACY||LS mean differences|-1.03|STANDARD_ERROR_OF_MEAN|2.06||0.6161|TWO_SIDED|95.0|-5.08|3.01|||ANCOVA|||Baseline sleep disturbance: ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and combined center, for post-baseline assessments baseline was included as a covariate.||3.01|-5.08|0.6161
72557605|NCT00205777|144645439|SUPERIORITY_OR_OTHER|||||||0.34|||||||ANCOVA|||Percent change at Month 72 in lumbar spine BMD: P value was calculated using ANCOVA.||||0.34
72557606|NCT00205777|144645439|SUPERIORITY_OR_OTHER|||||||0.15|||||||ANCOVA|||Percent change at Month 84 in lumbar spine BMD: P value was calculated using ANCOVA.||||0.15
72557607|NCT00205777|144645439|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Percent change at Month 72 in total hip BMD: P value was calculated using ANCOVA.||||<0.001
72382725|NCT00537238|144274188|SUPERIORITY_OR_OTHER_LEGACY||LS mean differences|-1.63|STANDARD_ERROR_OF_MEAN|1.62||0.3154|TWO_SIDED|95.0|-4.83|1.56|||ANCOVA|||Week 16 sleep disturbance: ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and combined center, for post-baseline assessments baseline was included as a covariate.||1.56|-4.83|0.3154
72557608|NCT00205777|144645439|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Percent change at Month 84 in total hip BMD: P value was calculated using ANCOVA.||||<0.001
72557609|NCT00205777|144645439|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANCOVA|||Percent change at Month 72 in femoral neck BMD: P value was calculated using ANCOVA.||||<0.001
72557610|NCT00205777|144645439|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Percent change at Month 84 in femoral neck BMD: P value was calculated using ANCOVA.||||<0.001
72557611|NCT00205777|144645439|SUPERIORITY_OR_OTHER|||||||0.003||95.0|||||ANCOVA|||Percent change at Month 72 in femoral trochanter BMD: P value was calculated using ANCOVA.||||0.003
72557612|NCT00205777|144645439|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||ANCOVA|||Percent change at Month 84 in femoral trochanter BMD: P value was calculated using ANCOVA.||||0.002
72557613|NCT00205777|144645440|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Ranked ANCOVA|||Percent change at Month 3 in osteocalcin: P value was calculated using Ranked ANCOVA.||||<0.001
72557614|NCT00205777|144645440|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Ranked ANCOVA|||Percent change at Month 3 in osteocalcin: P value was calculated using Ranked ANCOVA.||||<0.001
72557615|NCT00205777|144645440|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Ranked ANCOVA|||Percent change at Month 3 in osteocalcin: P value was calculated using Ranked ANCOVA.||||<0.001
72557616|NCT00205777|144645440|SUPERIORITY_OR_OTHER|||||||0.93|TWO_SIDED||||||Ranked ANCOVA|||Percent change at Month 3 in osteocalcin: P value was calculated using Ranked ANCOVA.||||0.93
72557617|NCT00205777|144645440|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Ranked ANCOVA|||Percent change at Month 3 in osteocalcin: P value was calculated using Ranked ANCOVA.||||<0.001
72557618|NCT00205777|144645440|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Ranked ANCOVA|||Percent change at Month 6 in osteocalcin: P value was calculated using Ranked ANCOVA.||||<0.001
72557619|NCT00205777|144645440|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Ranked ANCOVA|||Percent change at Month 6 in osteocalcin: P value was calculated using Ranked ANCOVA.||||<0.001
72557620|NCT00205777|144645440|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Ranked ANCOVA|||Percent change at Month 6 in osteocalcin: P value was calculated using Ranked ANCOVA.||||<0.001
72557621|NCT00205777|144645440|SUPERIORITY_OR_OTHER|||||||0.3||95.0|||||Ranked ANCOVA|||Percent change at Month 6 in osteocalcin: P value was calculated using Ranked ANCOVA.||||0.30
72557622|NCT00205777|144645440|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Ranked ANCOVA|||Percent change at Month 6 in osteocalcin: P value was calculated using Ranked ANCOVA.||||<0.001
72557623|NCT00205777|144645440|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Ranked ANCOVA|||Percent change at Month 12 in osteocalcin: P value was calculated using Ranked ANCOVA.||||<0.001
72557624|NCT00205777|144645440|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Ranked ANCOVA|||Percent change at Month 12 in osteocalcin: P value was calculated using Ranked ANCOVA.||||<0.001
72557625|NCT00205777|144645440|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Ranked ANCOVA|||Percent change at Month 12 in osteocalcin: P value was calculated using Ranked ANCOVA.||||<0.001
72557626|NCT00205777|144645440|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Ranked ANCOVA|||Percent change at Month 12 in osteocalcin: P value was calculated using Ranked ANCOVA.||||<0.001
72557627|NCT00205777|144645440|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Ranked ANCOVA|||Percent change at Month 12 in osteocalcin: P value was calculated using Ranked ANCOVA.||||<0.001
72557628|NCT00205777|144645441|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Ranked ANCOVA|||Percent change at Month 36 in osteocalcin: P value was calculated using Ranked ANCOVA.||||<0.001
72557629|NCT00205777|144645441|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Ranked ANCOVA|||Percent change at Month 60 in osteocalcin: P value was calculated using Ranked ANCOVA.||||<0.001
72557630|NCT00205777|144645441|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Ranked ANCOVA|||Percent change at Month 36 in osteocalcin: P value was calculated using Ranked ANCOVA.||||<0.001
72557631|NCT00205777|144645441|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Ranked ANCOVA|||Percent change at Month 60 in osteocalcin: P value was calculated using Ranked ANCOVA.||||<0.001
72557632|NCT00205777|144645442|SUPERIORITY_OR_OTHER|||||||0.037|||||||Ranked ANCOVA|||Percent change at Month 72 in osteocalcin: P value was calculated using Ranked ANCOVA.||||0.037
72557633|NCT00205777|144645442|SUPERIORITY_OR_OTHER|||||||0.16|||||||Ranked ANCOVA|||Percent change at Month 84 in osteocalcin: P value was calculated using Ranked ANCOVA.||||0.16
72557634|NCT00205777|144645443|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Ranked ANCOVA|||Percent change at Month 3 in C-telopeptide: P value was calculated using Ranked ANCOVA.||||<0.001
72557635|NCT00205777|144645443|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Ranked ANCOVA|||Percent change at Month 3 in C-telopeptide: P value was calculated using Ranked ANCOVA.||||<0.001
72557636|NCT00205777|144645443|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Ranked ANCOVA|||Percent change at Month 3 in C-telopeptide: P value was calculated using Ranked ANCOVA.||||<0.001
72382726|NCT00537238|144274188|SUPERIORITY_OR_OTHER_LEGACY||LS mean differences|-1.7|STANDARD_ERROR_OF_MEAN|3.18||0.593|TWO_SIDED|95.0|-7.94|4.54|||ANCOVA|||Baseline snoring: ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and combined center, for post-baseline assessments baseline was included as a covariate.||4.54|-7.94|0.5930
72382727|NCT00537238|144274188|SUPERIORITY_OR_OTHER_LEGACY||LS mean differences|10.02|STANDARD_ERROR_OF_MEAN|2.42|<|0.0001|TWO_SIDED|95.0|5.27|14.76|||ANCOVA|||Week 16 snoring: ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and combined center, for post-baseline assessments baseline was included as a covariate.||14.76|5.27|<0.0001
72382728|NCT00537238|144274188|SUPERIORITY_OR_OTHER_LEGACY||LS mean differences|-1.54|STANDARD_ERROR_OF_MEAN|2.18||0.4807|TWO_SIDED|95.0|-5.83|2.75|||ANCOVA|||Baseline awaken short of breath: ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and combined center, for post-baseline assessments baseline was included as a covariate.||2.75|-5.83|0.4807
72382729|NCT00537238|144274188|SUPERIORITY_OR_OTHER_LEGACY||LS mean differences|0.88|STANDARD_ERROR_OF_MEAN|2.07||0.6708|TWO_SIDED|95.0|-3.18|4.94|||ANCOVA|||Week 16 awaken short of breath: ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and combined center, for post-baseline assessments baseline was included as a covariate.||4.94|-3.18|0.6708
72557637|NCT00205777|144645443|SUPERIORITY_OR_OTHER|||||||0.4|||||||Ranked ANCOVA|||Percent change at Month 3 in C-telopeptide: P value was calculated using Ranked ANCOVA.||||0.40
72557638|NCT00205777|144645443|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Ranked ANCOVA|||Percent change at Month 3 in C-telopeptide: P value was calculated using Ranked ANCOVA.||||<0.001
72557639|NCT00205777|144645443|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Ranked ANCOVA|||Percent change at Month 6 in C-telopeptide: P value was calculated using Ranked ANCOVA.||||<0.001
72557640|NCT00205777|144645443|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Ranked ANCOVA|||Percent change at Month 6 in C-telopeptide: P value was calculated using Ranked ANCOVA.||||<0.001
72557641|NCT00205777|144645443|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Ranked ANCOVA|||Percent change at Month 6 in C-telopeptide: P value was calculated using Ranked ANCOVA.||||<0.001
72557642|NCT00205777|144645443|SUPERIORITY_OR_OTHER|||||||0.004|||||||Ranked ANCOVA|||Percent change at Month 6 in C-telopeptide: P value was calculated using Ranked ANCOVA.||||0.004
72557643|NCT00205777|144645443|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Ranked ANCOVA|||Percent change at Month 6 in C-telopeptide: P value was calculated using Ranked ANCOVA.||||<0.001
72557644|NCT00205777|144645443|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Ranked ANCOVA|||Percent change at Month 12 in C-telopeptide: P value was calculated using Ranked ANCOVA.||||<0.001
72557645|NCT00205777|144645443|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Ranked ANCOVA|||Percent change at Month 12 in C-telopeptide: P value was calculated using Ranked ANCOVA.||||<0.001
72557646|NCT00205777|144645443|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Ranked ANCOVA|||Percent change at Month 12 in C-telopeptide: P value was calculated using Ranked ANCOVA.||||<0.001
72557647|NCT00205777|144645443|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Ranked ANCOVA|||Percent change at Month 12 in C-telopeptide: P value was calculated using Ranked ANCOVA.||||<0.001
72557648|NCT00205777|144645443|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Ranked ANCOVA|||Percent change at Month 12 in C-telopeptide: P value was calculated using Ranked ANCOVA.||||<0.001
72557649|NCT00205777|144645444|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Ranked ANCOVA|||Percent change at Month 36 in C-telopeptide: P value was calculated using Ranked ANCOVA.||||<0.001
72557650|NCT00205777|144645444|SUPERIORITY_OR_OTHER|||||||0.001|||||||Ranked ANCOVA|||Percent change at Month 60 in C-telopeptide: P value was calculated using Ranked ANCOVA.||||0.001
72557651|NCT00205777|144645444|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Ranked ANCOVA|||Percent change at Month 36 in C-telopeptide: P value was calculated using Ranked ANCOVA.||||<0.001
72557652|NCT00205777|144645444|SUPERIORITY_OR_OTHER|||||||0.009|||||||Ranked ANCOVA|||Percent change at Month 60 in C-telopeptide: P value was calculated using Ranked ANCOVA.||||0.009
72557653|NCT00205777|144645445|SUPERIORITY_OR_OTHER|||||||0.034||95.0|||||Ranked ANCOVA|||Percent change at Month 72 in C-telopeptide: P value was calculated using Ranked ANCOVA.||||0.034
72494128|NCT03237065|144517210|SUPERIORITY||Mean Difference (Final Values)|-27.3||||0.3516|TWO_SIDED|95.0|-86.0|31.5|||Mixed model for repeated measures|||"Day 14~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||31.5|-86.0|0.3516
72434844|NCT04173572|144383154|OTHER|Single group mean difference between baseline and post-treatment assessments.|Mean Difference (Net)|-0.8|STANDARD_DEVIATION|9.9|||TWO_SIDED|||||||||Posttreatment - Baseline: 14 participants analyzed (had data at both time points)||||
72434845|NCT04173572|144383154|OTHER|Single group mean difference between baseline and post-treatment assessments.|Mean Difference (Net)|0.714|STANDARD_DEVIATION|11.717|||TWO_SIDED|||||||||Posttreatment - Baseline: 14 participants analyzed (had data at both time points)||||
72434846|NCT04173572|144383155|OTHER|Single group mean difference between baseline and post-treatment assessments.|Mean Difference (Net)|3.071|STANDARD_DEVIATION|10.737|||TWO_SIDED|||||||||Posttreatment - Baseline: 14 participants analyzed (had data at both time points)||||
72434847|NCT04173572|144383155|OTHER|Single group mean difference between baseline and post-treatment assessments.|Mean Difference (Net)|5.571|STANDARD_DEVIATION|9.288|||TWO_SIDED|||||||||Posttreatment - Baseline: 14 participants analyzed (had data at both time points)||||
72434848|NCT00383188|144383162|SUPERIORITY||Difference in percentage|8.05|STANDARD_ERROR_OF_MEAN|7.97||0.3131|TWO_SIDED|95.0|-7.565|23.664|||Chi-squared|||||23.664|-7.565|0.3131
72434849|NCT00383188|144383162|SUPERIORITY||Difference in percentage|10.81|STANDARD_ERROR_OF_MEAN|7.86||0.1719|TWO_SIDED|95.0|-4.602|26.224|||Chi-squared|||||26.224|-4.602|0.1719
72434850|NCT00383188|144383162|SUPERIORITY||Difference in percentage|9.83|STANDARD_ERROR_OF_MEAN|9.16||0.2783|TWO_SIDED|95.0|-8.123|27.799|||Chi-squared|||||27.799|-8.123|0.2783
72504715|NCT03065530|144540360|OTHER||||||<|0.05|||||||Kruskal-Wallis|||The sample size was calculated on the basis of an our initial pilot study, and the SD was 1.4 between the four groups. We hypothesized that the differences in VAS between the four groups and the SDs would be 15%. A power analysis suggested that there will be 80% power to detect differences at an α=0.05 significance level (two-tailed), including 24 individuals per treatment group. Considering the exclusion of 25% of patients, 30 parturients were eventually recruited in each group.||||<0.05
72434851|NCT00383188|144383162|SUPERIORITY||Difference in percentage|8.92|STANDARD_ERROR_OF_MEAN|9.43||0.3381|TWO_SIDED|95.0|-9.566|27.404|||Chi-squared|||||27.404|-9.566|0.3381
72434852|NCT00383188|144383163|SUPERIORITY||Difference in percentage|1.04|STANDARD_ERROR_OF_MEAN|5.96||0.8619|TWO_SIDED|90.0|-8.733|10.845|||Chi-squared|||Week 1||10.845|-8.733|0.8619
72434853|NCT00383188|144383163|SUPERIORITY||Difference in percentage|7.24|STANDARD_ERROR_OF_MEAN|6.33||0.2546|TWO_SIDED|90.0|-3.176|17.651|||Chi-squared|||Week 1||17.651|-3.176|0.2546
72434854|NCT00383188|144383163|SUPERIORITY||Difference in percentage|14.02|STANDARD_ERROR_OF_MEAN|7.96||0.0644|TWO_SIDED|90.0|0.921|27.115|||Chi-squared|||Week 1||27.115|0.921|0.0644
72434855|NCT00383188|144383163|SUPERIORITY||Difference in percentage|1.5|STANDARD_ERROR_OF_MEAN|7.07||0.8304|TWO_SIDED|90.0|-10.13|13.125|||Chi-squared|||Week 1||13.125|-10.13|0.8304
72504716|NCT00479466|144540382|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-30.6|||<|0.001|TWO_SIDED|95.0|-44.0|-17.3|||ANCOVA|||||-17.3|-44.0|<0.001
72504717|NCT00479466|144540382|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-46.6|||<|0.001|TWO_SIDED|95.0|-59.7|-33.4|||ANCOVA|||||-33.4|-59.7|<0.001
72504718|NCT00479466|144540382|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-51.1|||<|0.001|TWO_SIDED|95.0|-64.3|-38.0|||ANCOVA|||||-38.0|-64.3|<0.001
72504719|NCT00479466|144540382|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-61.2|||<|0.001|TWO_SIDED|95.0|-74.6|-47.8|||ANCOVA|||||-47.8|-74.6|<0.001
72504720|NCT00479466|144540382|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-35.5|||<|0.001|TWO_SIDED|95.0|-48.6|-22.4|||ANCOVA|||||-22.4|-48.6|<0.001
72504721|NCT00479466|144540383|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.15|||<|0.001|TWO_SIDED|95.0|-1.53|-0.76|||ANCOVA|||||-0.76|-1.53|<0.001
72504722|NCT00479466|144540383|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.53|||<|0.001|TWO_SIDED|95.0|-1.91|-1.15|||ANCOVA|||||-1.15|-1.91|<0.001
72504723|NCT00479466|144540383|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.69|||<|0.001|TWO_SIDED|95.0|-2.07|-1.31|||ANCOVA|||||-1.31|-2.07|<0.001
72504724|NCT00479466|144540383|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.06|||<|0.001|TWO_SIDED|95.0|-2.45|-1.68|||ANCOVA|||||-1.68|-2.45|<0.001
72504725|NCT00479466|144540383|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.32|||<|0.001|TWO_SIDED|95.0|-1.7|-0.95|||ANCOVA|||||-0.95|-1.70|<0.001
72504726|NCT00479466|144540384|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-56.8|||<|0.001|TWO_SIDED|95.0|-79.4|-34.3|||ANCOVA|||||-34.3|-79.4|<0.001
72504727|NCT00479466|144540384|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-70.0|||<|0.001|TWO_SIDED|95.0|-91.8|-48.2|||ANCOVA|||||-48.2|-91.8|<0.001
72504728|NCT00479466|144540384|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-87.4|||<|0.001|TWO_SIDED|95.0|-109.4|-65.3|||ANCOVA|||||-65.3|-109.4|<0.001
72504729|NCT00479466|144540384|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-101.6|||<|0.001|TWO_SIDED|95.0|-124.2|-79.1|||ANCOVA|||||-79.1|-124.2|<0.001
72504730|NCT00479466|144540384|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-60.8|||<|0.001|TWO_SIDED|95.0|-82.7|-38.8|||ANCOVA|||||-38.8|-82.7|<0.001
72504731|NCT03291197|144540400|OTHER|||||||0.043|||||||Wilcoxon (Mann-Whitney)|||Our study was not powered to perform statistical analysis though was still conduct to look for a trend in reduction of VAS.||||0.043
72504732|NCT01633060|144540402|OTHER|Comparison of progression-free survival (PFS) (based on local investigator assessment) between the two treatment groups using a stratified log-rank test at one-sided 2.5% level of significance|Hazard Ratio (HR)|0.67|||<|0.001|ONE_SIDED|95.0|0.53||||Log Rank||||||0.53|<0.001
72504733|NCT03114969|144540498|SUPERIORITY||Odds Ratio (OR)|4.657||||0.005|TWO_SIDED|95.0|1.584|13.686||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator.|||13.686|1.584|0.005
72557654|NCT00205777|144645445|SUPERIORITY_OR_OTHER|||||||0.77||95.0|||||Ranked ANCOVA|||Percent change at Month 84 in C-telopeptide: P value was calculated using Ranked ANCOVA.||||0.77
72434856|NCT00383188|144383163|SUPERIORITY||Difference in percentage|6.11|STANDARD_ERROR_OF_MEAN|7.45||0.4123|TWO_SIDED|90.0|-6.15|18.371|||Chi-squared|||Week 2||18.371|-6.150|0.4123
72434857|NCT00383188|144383163|SUPERIORITY||Difference in percentage|5.41|STANDARD_ERROR_OF_MEAN|7.29||0.4591|TWO_SIDED|90.0|-6.581|17.392|||Chi-squared|||Week 2||17.392|-6.581|0.4591
72434858|NCT00383188|144383163|SUPERIORITY||Difference in percentage|16.58|STANDARD_ERROR_OF_MEAN|8.93||0.0585|TWO_SIDED|90.0|1.89|31.28|||Chi-squared|||Week 2||31.280|1.890|0.0585
72434859|NCT00383188|144383163|SUPERIORITY||Difference in percentage|15.68|STANDARD_ERROR_OF_MEAN|9.21||0.0808|TWO_SIDED|90.0|0.522|30.829|||Chi-squared|||Week 2||30.829|0.522|0.0808
72434860|NCT00383188|144383163|SUPERIORITY||Difference in percentage|4.86|STANDARD_ERROR_OF_MEAN|7.62||0.524|TWO_SIDED|90.0|-7.684|17.398|||Chi-squared|||Week 4||17.398|-7.684|0.5240
72434861|NCT00383188|144383163|SUPERIORITY||Difference in percentage|14.86|STANDARD_ERROR_OF_MEAN|7.72||0.0571|TWO_SIDED|90.0|2.172|27.588|||Chi-squared|||Week 4||27.588|2.172|0.0571
72434862|NCT00383188|144383163|SUPERIORITY||Difference in percentage|16.15|STANDARD_ERROR_OF_MEAN|9.08||0.0712|TWO_SIDED|90.0|1.222|31.087|||Chi-squared|||Week 4||31.087|1.222|0.0712
72434863|NCT00383188|144383163|SUPERIORITY||Difference in percentage|20.47|STANDARD_ERROR_OF_MEAN|9.43||0.0279|TWO_SIDED|90.0|4.956|35.99|||Chi-squared|||Week 4||35.990|4.956|0.0279
72557655|NCT00205777|144645446|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANCOVA|||Percent change at Month 6 in total cholesterol: P value was calculated using ANCOVA.||||<0.001
72557656|NCT00205777|144645446|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Percent change at Month 12 in total cholesterol: P value was calculated using ANCOVA.||||<0.001
72434864|NCT00383188|144383163|SUPERIORITY||Difference in Percentage|-2.1|STANDARD_ERROR_OF_MEAN|7.67||0.7848|TWO_SIDED|90.0|-14.71|10.515|||Chi-squared|||Week 8||10.515|-14.71|0.7848
72434865|NCT00383188|144383163|SUPERIORITY||Difference in percentage|14.86|STANDARD_ERROR_OF_MEAN|7.91||0.0632|TWO_SIDED|90.0|1.86|27.869|||Chi-squared|||Week 8||27.869|1.860|0.0632
72434866|NCT00383188|144383163|SUPERIORITY||Difference in percentage|9.83|STANDARD_ERROR_OF_MEAN|9.16||0.2783|TWO_SIDED|90.0|-5.237|24.893|||Chi-squared|||Week 8||24.893|-5.237|0.2783
72434867|NCT00383188|144383163|SUPERIORITY||Difference in percentage|16.42|STANDARD_ERROR_OF_MEAN|9.55||0.0828|TWO_SIDED|90.0|0.703|32.135|||Chi-squared|||Week 8||32.135|0.703|0.0828
72434868|NCT00383188|144383163|SUPERIORITY||Difference in percentage|-2.72|STANDARD_ERROR_OF_MEAN|8.54||0.7505|TWO_SIDED|90.0|-16.77|11.328|||Chi-squared|||Week 16||11.328|-16.77|0.7505
72557657|NCT00205777|144645446|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Percent change at Month 24 in total cholesterol: P value was calculated using ANCOVA.||||<0.001
72557658|NCT00205777|144645446|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Percent change at Month 36 in total cholesterol: P value was calculated using ANCOVA.||||<0.001
72618701|NCT01026038|144768108|SUPERIORITY_OR_OTHER||GMT ratio|0.6|||||TWO_SIDED|95.0|0.38|0.88||||||Serotype 1: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||0.88|0.38|
72434869|NCT00383188|144383163|SUPERIORITY||Difference in percentage|1.43|STANDARD_ERROR_OF_MEAN|8.35||0.8641|TWO_SIDED|90.0|-12.3|15.156|||Chi-squared|||Week 16||15.156|-12.30|0.8641
72434870|NCT00383188|144383163|SUPERIORITY||Difference in percentage|3.31|STANDARD_ERROR_OF_MEAN|9.99||0.7399|TWO_SIDED|90.0|-13.12|19.734|||Chi-squared|||Week 16||19.734|-13.12|0.7399
72557659|NCT00205777|144645446|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Percent change at Month 6 in total cholesterol: P value was calculated using ANCOVA.||||<0.001
72434871|NCT00383188|144383163|SUPERIORITY||Difference in percentage|-12.48|STANDARD_ERROR_OF_MEAN|9.42||0.1996|TWO_SIDED|90.0|-27.98|3.018|||Chi-squared|||Week 16||3.018|-27.98|0.1996
72434872|NCT00383188|144383164|SUPERIORITY||Difference in percentage|1.49|STANDARD_ERROR_OF_MEAN|1.48||0.2982|TWO_SIDED|90.0|-0.944|3.929|||Chi-squared|||Week 1||3.929|-0.944|0.2982
72434873|NCT00383188|144383164|SUPERIORITY||Difference in percentage|1.41|STANDARD_ERROR_OF_MEAN|1.4||0.3122|TWO_SIDED|90.0|-0.892|3.709|||Chi-squared|||Week 1||3.709|-0.892|0.3122
72434874|NCT00383188|144383164|SUPERIORITY||Difference in percentage|4.65|STANDARD_ERROR_OF_MEAN|3.21||0.0649|TWO_SIDED|90.0|-0.631|9.934|||Chi-squared|||Week 1||9.934|-0.631|0.0649
72434875|NCT00383188|144383164|SUPERIORITY||Difference in percentage|5.13|STANDARD_ERROR_OF_MEAN|3.53||0.0525|TWO_SIDED|90.0|-0.681|10.938|||Chi-squared|||Week 1||10.938|-0.681|0.0525
72434876|NCT00383188|144383164|SUPERIORITY||Difference in percentage|4.45|STANDARD_ERROR_OF_MEAN|3.12||0.1481|TWO_SIDED|90.0|-0.681|9.573|||Chi-squared|||Week 2||9.573|-0.681|0.1481
72434877|NCT00383188|144383164|SUPERIORITY||Difference in percentage|8.11|STANDARD_ERROR_OF_MEAN|3.66||0.0292|TWO_SIDED|90.0|2.093|14.124|||Chi-squared|||Week 2||14.124|2.093|0.0292
72434878|NCT00383188|144383164|SUPERIORITY||Difference in percentage|10.01|STANDARD_ERROR_OF_MEAN|4.97||0.0167|TWO_SIDED|90.0|1.839|18.186|||Chi-squared|||Week 2||18.186|1.839|0.0167
72557660|NCT00205777|144645446|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Percent change at Month 12 in total cholesterol: P value was calculated using ANCOVA.||||<0.001
72557661|NCT00205777|144645446|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Percent change at Month 24 in total cholesterol: P value was calculated using ANCOVA.||||<0.001
72557662|NCT00205777|144645446|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||ANCOVA|||Percent change at Month 36 in total cholesterol: P value was calculated using ANCOVA.||||0.001
72557663|NCT00205777|144645446|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Percent change at Month 6 in total cholesterol: P value was calculated using ANCOVA.||||<0.001
72557664|NCT00205777|144645446|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Percent change at Month 12 in total cholesterol: P value was calculated using ANCOVA.||||<0.001
72557665|NCT00205777|144645446|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Percent change at Month 24 in total cholesterol: P value was calculated using ANCOVA.||||<0.001
72557666|NCT00205777|144645446|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Percent change at Month 36 in total cholesterol: P value was calculated using ANCOVA.||||<0.001
72557667|NCT00205777|144645446|SUPERIORITY_OR_OTHER|||||||0.009||95.0|||||ANCOVA|||Percent change at Month 6 in total cholesterol: P value was calculated using ANCOVA.||||0.009
72557668|NCT00205777|144645446|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Percent change at Month 12 in total cholesterol: P value was calculated using ANCOVA.||||<0.001
72557669|NCT00205777|144645446|SUPERIORITY_OR_OTHER|||||||0.055||95.0|||||ANCOVA|||Percent change at Month 24 in total cholesterol: P value was calculated using ANCOVA.||||0.055
72557670|NCT00205777|144645446|SUPERIORITY_OR_OTHER|||||||0.004||95.0|||||ANCOVA|||Percent change at Month 36 in total cholesterol: P value was calculated using ANCOVA.||||0.004
72382730|NCT00537238|144274188|SUPERIORITY_OR_OTHER_LEGACY||LS mean differences|-0.04|STANDARD_ERROR_OF_MEAN|0.14||0.7574|TWO_SIDED|95.0|-0.32|0.24|||ANCOVA|||Baseline quantity of sleep: ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and combined center, for post-baseline assessments baseline was included as a covariate.||0.24|-0.32|0.7574
72382731|NCT00537238|144274188|SUPERIORITY_OR_OTHER_LEGACY||LS mean differences|0.14|STANDARD_ERROR_OF_MEAN|0.12||0.2615|TWO_SIDED|95.0|-0.1|0.38|||ANCOVA|||Week 16 quantity of sleep: ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and combined center, for post-baseline assessments baseline was included as a covariate.||0.38|-0.10|0.2615
72382732|NCT00537238|144274188|SUPERIORITY_OR_OTHER_LEGACY||LS mean differences|-1.44|STANDARD_ERROR_OF_MEAN|2.53||0.5703|TWO_SIDED|95.0|-6.42|3.54|||ANCOVA|||Baseline adequacy of sleep: ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and combined center, for post-baseline assessments baseline was included as a covariate.||3.54|-6.42|0.5703
72382733|NCT00537238|144274188|SUPERIORITY_OR_OTHER_LEGACY||LS mean differences|-2.99|STANDARD_ERROR_OF_MEAN|2.41||0.216|TWO_SIDED|95.0|-7.74|1.75|||ANCOVA|||Week 16 adequacy of sleep: ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and combined center, for post-baseline assessments baseline was included as a covariate.||1.75|-7.74|0.2160
72382734|NCT00537238|144274188|SUPERIORITY_OR_OTHER_LEGACY||LS mean differences|1.07|STANDARD_ERROR_OF_MEAN|2.02||0.5952|TWO_SIDED|95.0|-2.89|5.03|||ANCOVA|||Baseline somnolence: ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and combined center, for post-baseline assessments baseline was included as a covariate.||5.03|-2.89|0.5952
72382735|NCT00537238|144274188|SUPERIORITY_OR_OTHER_LEGACY||LS mean differences|-0.72|STANDARD_ERROR_OF_MEAN|1.87||0.6984|TWO_SIDED|95.0|-4.4|2.95|||ANCOVA|||Week 16 somnolence: ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and combined center, for post-baseline assessments baseline was included as a covariate.||2.95|-4.40|0.6984
72618702|NCT01026038|144768108|SUPERIORITY_OR_OTHER||GMT ratio|0.5|||||TWO_SIDED|95.0|0.27|0.77||||||Serotype 1: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||0.77|0.27|
72382736|NCT00537238|144274188|SUPERIORITY_OR_OTHER_LEGACY||LS mean differences|0.13|STANDARD_ERROR_OF_MEAN|1.64||0.9389|TWO_SIDED|95.0|-3.09|3.34|||ANCOVA|||Baseline sleep problem index (9): ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and combined center, for post-baseline assessments baseline was included as a covariate.||3.34|-3.09|0.9389
72382737|NCT00537238|144274188|SUPERIORITY_OR_OTHER_LEGACY||LS mean differences|0.64|STANDARD_ERROR_OF_MEAN|1.34||0.6344|TWO_SIDED|95.0|-2.0|3.27|||ANCOVA|||Week 16 sleep problem index (9): ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and combined center, for post-baseline assessments baseline was included as a covariate.||3.27|-2.00|0.6344
72382738|NCT00537238|144274189|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.016||||0.9285|TWO_SIDED|95.0|0.715|1.444|||Regression, Logistic|||Baseline: Logistic regression model was used to estimate odds ratio and corresponding 95% CI of treatment difference, with treatment as fixed effect and for post-baseline assessments baseline was included as a covariate.||1.444|0.715|0.9285
72382739|NCT00537238|144274189|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.432||||0.0696|TWO_SIDED|95.0|0.972|2.11|||Regression, Logistic|||Week 16: Logistic regression model was used to estimate odds ratio and corresponding 95% CI of treatment difference, with treatment as fixed effect and for post-baseline assessments baseline was included as a covariate.||2.110|0.972|0.0696
72382740|NCT01325623|144274279|SUPERIORITY_OR_OTHER|||||||0.375|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero||Baseline to EMU Discharge||||0.375
72382741|NCT01325623|144274279|SUPERIORITY_OR_OTHER|||||||0.156|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero||Baseline to 3 Months||||0.156
72382742|NCT01325623|144274279|SUPERIORITY_OR_OTHER||||||>|0.999|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero||Baseline to 6 months||||>0.999
72382743|NCT01325623|144274279|SUPERIORITY_OR_OTHER|||||||0.906|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero||Baseline to 12 Months||||0.906
72382744|NCT01325623|144274279|SUPERIORITY_OR_OTHER|||||||0.188|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero||Baseline to 18 Months||||0.188
72434879|NCT00383188|144383164|SUPERIORITY||Difference in percentage|11.15|STANDARD_ERROR_OF_MEAN|5.4||0.011|TWO_SIDED|90.0|2.269|20.029|||Chi-squared|||Week 2||20.029|2.269|0.0110
72557671|NCT00205777|144645446|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Percent change at Month 6 in total cholesterol: P value was calculated using ANCOVA.||||<0.001
72557672|NCT00205777|144645446|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Percent change at Month 12 in total cholesterol: P value was calculated using ANCOVA.||||<0.001
72557673|NCT00205777|144645446|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Percent change at Month 24 in total cholesterol: P value was calculated using ANCOVA.||||<0.001
72557674|NCT00205777|144645446|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Percent change at Month 36 in total cholesterol: P value was calculated using ANCOVA.||||<0.001
72557675|NCT00205777|144645446|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Percent change at Month 6 in LDL: P value was calculated using ANCOVA.||||<0.001
72557676|NCT00205777|144645446|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Percent change at Month 12 in LDL: P value was calculated using ANCOVA.||||<0.001
72382745|NCT01325623|144274279|SUPERIORITY_OR_OTHER|||||||0.906|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero||Baseline to 24 Months||||0.906
72382746|NCT01325623|144274279|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero||Baseline to EMU Discharge||||<0.001
72382747|NCT01325623|144274279|SUPERIORITY_OR_OTHER|||||||0.106|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero||Baseline to 3 Months||||0.106
72434880|NCT00383188|144383164|SUPERIORITY||Difference in percentage|-2.51|STANDARD_ERROR_OF_MEAN|3.31||0.455|TWO_SIDED|90.0|-7.959|2.946|||Chi-squared|||Week 4||2.946|-7.959|0.4550
72434881|NCT00383188|144383164|SUPERIORITY||Difference in percentage|8.11|STANDARD_ERROR_OF_MEAN|4.76||0.0919|TWO_SIDED|90.0|0.271|15.946|||Chi-squared|||Week 4||15.946|0.271|0.0919
72434882|NCT00383188|144383164|SUPERIORITY||Difference in percentage|12.78|STANDARD_ERROR_OF_MEAN|6.38||0.0264|TWO_SIDED|90.0|2.28|23.272|||Chi-squared|||Week 4||23.272|2.280|0.0264
72434883|NCT00383188|144383164|SUPERIORITY||Difference in percentage|12.09|STANDARD_ERROR_OF_MEAN|6.56||0.0369|TWO_SIDED|90.0|1.308|22.881|||Chi-squared|||Week 4||22.881|1.308|0.0369
72434884|NCT00383188|144383164|SUPERIORITY||Difference in percentage|-9.17|STANDARD_ERROR_OF_MEAN|4.67||0.0568|TWO_SIDED|90.0|-16.85|-1.482|||Chi-squared|||Week 8||-1.482|-16.85|0.0568
72434885|NCT00383188|144383164|SUPERIORITY||Difference in percentage|4.05|STANDARD_ERROR_OF_MEAN|5.95||0.4961|TWO_SIDED|90.0|-5.727|13.835|||Chi-squared|||Week 8||13.835|-5.727|0.4961
72434886|NCT00383188|144383164|SUPERIORITY||Difference in percentage|6.94|STANDARD_ERROR_OF_MEAN|7.26||0.3212|TWO_SIDED|90.0|-5.008|18.89|||Chi-squared|||Week 8||18.890|-5.008|0.3212
72434887|NCT00383188|144383164|SUPERIORITY||Difference in percentage|1.49|STANDARD_ERROR_OF_MEAN|6.9||0.8274|TWO_SIDED|90.0|-9.87|12.843|||Chi-squared|||Week 8||12.843|-9.870|0.8274
72434888|NCT00383188|144383164|SUPERIORITY||Difference in percentage|5.23|STANDARD_ERROR_OF_MEAN|5.94||0.3774|TWO_SIDED|90.0|-4.538|14.996|||Chi-squared|||Week 12||14.996|-4.538|0.3774
72434889|NCT00383188|144383164|SUPERIORITY||Difference in percentage|9.46|STANDARD_ERROR_OF_MEAN|6.11||0.1246|TWO_SIDED|90.0|-0.591|19.51|||Chi-squared|||Week 12||19.510|-0.591|0.1246
72434890|NCT00383188|144383164|SUPERIORITY||Difference in percentage|8.29|STANDARD_ERROR_OF_MEAN|7.17||0.2257|TWO_SIDED|90.0|-3.502|20.087|||Chi-squared|||Week 12||20.087|-3.502|0.2257
72618703|NCT01026038|144768108|SUPERIORITY_OR_OTHER||GMT ratio|2.0|||||TWO_SIDED|95.0|0.85|4.9||||||Serotype 3: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||4.90|0.85|
72382748|NCT01325623|144274279|SUPERIORITY_OR_OTHER|||||||0.012|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero||Baseline to 6 Months||||0.012
72382749|NCT01325623|144274279|SUPERIORITY_OR_OTHER|||||||0.008|TWO_SIDED||||||s|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero||Baseline to 12 Months||||0.008
72382750|NCT01325623|144274279|SUPERIORITY_OR_OTHER|||||||0.009|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero||Baseline to 18 Months||||0.009
72382751|NCT01325623|144274279|SUPERIORITY_OR_OTHER|||||||0.029|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero||Baseline to 24 Months||||0.029
72434891|NCT00383188|144383164|SUPERIORITY||Difference in percentage|5.34|STANDARD_ERROR_OF_MEAN|7.11||0.4336|TWO_SIDED|90.0|-6.355|17.03|||Chi-squared|||Week 12||17.030|-6.355|0.4336
72434892|NCT00383188|144383164|SUPERIORITY||Difference in percentage|-2.07|STANDARD_ERROR_OF_MEAN|7.02||0.7682|TWO_SIDED|90.0|-13.61|9.467|||Chi-squared|||Week 16||9.467|-13.61|0.7682
72434893|NCT00383188|144383164|SUPERIORITY||Difference in percentage|-2.86|STANDARD_ERROR_OF_MEAN|6.76||0.6726|TWO_SIDED|90.0|-13.97|8.257|||Chi-squared|||Week 16||8.257|-13.97|0.6726
72434894|NCT00383188|144383164|SUPERIORITY||Difference in percentage|-5.64|STANDARD_ERROR_OF_MEAN|7.68||0.4795|TWO_SIDED|90.0|-18.28|7.0|||Chi-squared|||Week 16||7.000|-18.28|0.4795
72434895|NCT00383188|144383164|SUPERIORITY||Difference in percentage|-16.17|STANDARD_ERROR_OF_MEAN|6.1||0.0276|TWO_SIDED|90.0|-26.19|-6.137|||Chi-squared|||Week 16||-6.137|-26.19|0.0276
72434896|NCT00383188|144383165|SUPERIORITY||Difference in percentage|0.0|STANDARD_ERROR_OF_MEAN|0.0||0|TWO_SIDED|90.0|0.0|0.0|||Chi-squared|||Week 1||0.00|0.00|0.000
72434897|NCT00383188|144383165|SUPERIORITY||Difference in percentage|0.0|STANDARD_ERROR_OF_MEAN|0.0||0|TWO_SIDED|90.0|0.0|0.0|||Chi-squared|||Week 1||0.00|0.00|0.000
72434898|NCT00383188|144383165|SUPERIORITY||Difference in percentage|0.0|STANDARD_ERROR_OF_MEAN|0.0||0|TWO_SIDED|90.0|0.0|0.0|||Chi-squared|||Week 1||0.00|0.00|0.000
72434899|NCT00383188|144383165|SUPERIORITY||Difference in percentage|0.0|STANDARD_ERROR_OF_MEAN|0.0||0|TWO_SIDED|90.0|0.0|0.0|||Chi-squared|||Week 1||0.00|0.00|0.000
72434900|NCT00383188|144383165|SUPERIORITY||Difference in percentage|0.0|STANDARD_ERROR_OF_MEAN|0.0||0|TWO_SIDED|90.0|0.0|0.0|||Chi-squared|||Week 2||0.00|0.00|0.000
72434901|NCT00383188|144383165|SUPERIORITY||Difference in percentage|0.0|STANDARD_ERROR_OF_MEAN|0.0||0|TWO_SIDED|90.0|0.0|0.0|||Chi-squared|||Week 2||0.00|0.00|0.000
72557677|NCT00205777|144645446|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Percent change at Month 24 in LDL: P value was calculated using ANCOVA.||||<0.001
72557678|NCT00205777|144645446|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Percent change at Month 36 in LDL: P value was calculated using ANCOVA.||||<0.001
72557679|NCT00205777|144645446|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Percent change at Month 6 in LDL: P value was calculated using ANCOVA.||||<0.001
72557680|NCT00205777|144645446|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Percent change at Month 12 in LDL: P value was calculated using ANCOVA.||||<0.001
72557681|NCT00205777|144645446|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Percent change at Month 24 in LDL: P value was calculated using ANCOVA.||||<0.001
72557682|NCT00205777|144645446|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Percent change at Month 36 in LDL: P value was calculated using ANCOVA.||||<0.001
72557683|NCT00205777|144645446|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Percent change at Month 6 in LDL: P value was calculated using ANCOVA.||||<0.001
72382752|NCT01325623|144274279|SUPERIORITY_OR_OTHER|||||||0.5|TWO_SIDED||||||s|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero||Baseline to EMU Discharge||||0.500
72382753|NCT01325623|144274279|SUPERIORITY_OR_OTHER||||||>|0.999|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero||Baseline to 3 Months||||>0.999
72382754|NCT01325623|144274279|SUPERIORITY_OR_OTHER|||||||0.5|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero||Baseline to 6 Months||||0.500
72382755|NCT01325623|144274279|SUPERIORITY_OR_OTHER|||||||0.5|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero||Baseline to 12 Months||||0.500
72382756|NCT01325623|144274279|SUPERIORITY_OR_OTHER|||||||0.188|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero||Baseline to 18 Months||||0.188
72382757|NCT01325623|144274279|SUPERIORITY_OR_OTHER|||||||0.5|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero||Baseline to 24 Months||||0.500
72382758|NCT01325623|144274279|SUPERIORITY_OR_OTHER|||||||0.5|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero||Baseline to EMU Discharge||||0.500
72382759|NCT01325623|144274279|SUPERIORITY_OR_OTHER||||||>|0.999|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero||Baseline to 3 Months||||>0.999
72382760|NCT01325623|144274279|SUPERIORITY_OR_OTHER||||||>|0.999|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero||Baseline to 6 Months||||>0.999
72557684|NCT00205777|144645446|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Percent change at Month 12 in LDL: P value was calculated using ANCOVA.||||<0.001
72382761|NCT01325623|144274279|SUPERIORITY_OR_OTHER|||||||0.125|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero||Baseline to 12 Months||||0.125
72382762|NCT01325623|144274279|SUPERIORITY_OR_OTHER|||||||0.5|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero||Baseline to 18 Months||||0.500
72382763|NCT01325623|144274279|SUPERIORITY_OR_OTHER|||||||0.5|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero||Baseline to 24 Months||||0.500
72382764|NCT01325623|144274280|SUPERIORITY_OR_OTHER|||||||0.1529|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||SSQ Total Score||||0.1529
72382765|NCT01325623|144274280|SUPERIORITY_OR_OTHER|||||||0.0942|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Activity During Seizures Score||||0.0942
72382766|NCT01325623|144274280|SUPERIORITY_OR_OTHER|||||||0.2831|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Overall Recovery Score||||0.2831
72382767|NCT01325623|144274280|SUPERIORITY_OR_OTHER|||||||0.3639|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Overall Severity Score||||0.3639
72382768|NCT01325623|144274280|SUPERIORITY_OR_OTHER|||||||0.447|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Postictal Emotional Recovery Score||||0.4470
72382769|NCT01325623|144274280|SUPERIORITY_OR_OTHER|||||||0.1311|TWO_SIDED||||||s|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Postictal Physical Recovery Score||||0.1311
72382770|NCT01325623|144274280|SUPERIORITY_OR_OTHER|||||||0.3898|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Postictal Cognitive Recovery Score||||0.3898
72382771|NCT01325623|144274280|SUPERIORITY_OR_OTHER|||||||0.0511|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||SSQ Total Score||||0.0511
72557685|NCT00205777|144645446|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Percent change at Month 24 in LDL: P value was calculated using ANCOVA.||||<0.001
72557686|NCT00205777|144645446|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Percent change at Month 36 in LDL: P value was calculated using ANCOVA.||||<0.001
72557687|NCT00205777|144645446|SUPERIORITY_OR_OTHER|||||||0.012||95.0|||||ANCOVA|||Percent change at Month 6 in LDL: P value was calculated using ANCOVA.||||0.012
72557688|NCT00205777|144645446|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Percent change at Month 12 in LDL: P value was calculated using ANCOVA.||||<0.001
72557689|NCT00205777|144645446|SUPERIORITY_OR_OTHER|||||||0.031||95.0|||||ANCOVA|||Percent change at Month 24 in LDL: P value was calculated using ANCOVA.||||0.031
72557690|NCT00205777|144645446|SUPERIORITY_OR_OTHER|||||||0.008||95.0|||||ANCOVA|||Percent change at Month 36 in LDL: P value was calculated using ANCOVA.||||0.008
72557691|NCT00205777|144645446|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Percent change at Month 6 in LDL: P value was calculated using ANCOVA.||||<0.001
72557692|NCT00205777|144645446|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Percent change at Month 12 in LDL: P value was calculated using ANCOVA.||||<0.001
72618704|NCT01026038|144768108|SUPERIORITY_OR_OTHER||GMT ratio|1.1|||||TWO_SIDED|95.0|0.49|2.48||||||Serotype 3: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||2.48|0.49|
72382772|NCT01325623|144274280|SUPERIORITY_OR_OTHER|||||||0.0019|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Activity During Seizures Score||||0.0019
72434902|NCT00383188|144383165|SUPERIORITY||Difference in percentage|2.27|STANDARD_ERROR_OF_MEAN|2.25||0.1928|TWO_SIDED|90.0|-1.423|5.968|||Chi-squared|||Week 2||5.968|-1.423|0.1928
72434903|NCT00383188|144383165|SUPERIORITY||Difference in percentage|2.5|STANDARD_ERROR_OF_MEAN|2.47||0.1719|TWO_SIDED|90.0|-1.56|6.56|||Chi-squared|||Week 2||6.560|-1.560|0.1719
72434904|NCT00383188|144383165|SUPERIORITY||Difference in percentage|0.1|STANDARD_ERROR_OF_MEAN|1.97||0.9603|TWO_SIDED|90.0|-3.138|3.334|||Chi-squared|||Week 4||3.334|-3.138|0.9603
72434905|NCT00383188|144383165|SUPERIORITY||Difference in percentage|-1.35|STANDARD_ERROR_OF_MEAN|1.34||0.3157|TWO_SIDED|90.0|-3.559|0.856|||Chi-squared|||Week 4||0.856|-3.559|0.3157
72434906|NCT00383188|144383165|SUPERIORITY||Difference in percentage|5.47|STANDARD_ERROR_OF_MEAN|4.03||0.1125|TWO_SIDED|90.0|-1.162|12.096|||Chi-squared|||Week 4||12.096|-1.162|0.1125
72434907|NCT00383188|144383165|SUPERIORITY||Difference in percentage|3.65|STANDARD_ERROR_OF_MEAN|3.7||0.2455|TWO_SIDED|90.0|-2.434|9.732|||Chi-squared|||Week 4||9.732|-2.434|0.2455
72434908|NCT00383188|144383165|SUPERIORITY||Difference in percentage|-2.6|STANDARD_ERROR_OF_MEAN|2.71||0.3452|TWO_SIDED|90.0|-7.057|1.847|||Chi-squared|||Week 8||1.847|-7.057|0.3452
72434909|NCT00383188|144383165|SUPERIORITY||Difference in percentage|0.0|STANDARD_ERROR_OF_MEAN|3.24||1|TWO_SIDED|90.0|-5.333|5.333|||Chi-squared|||Week 8||5.333|-5.333|1.0000
72434910|NCT00383188|144383165|SUPERIORITY||Difference in percentage|7.31|STANDARD_ERROR_OF_MEAN|5.31||0.1267|TWO_SIDED|90.0|-1.417|16.036|||Chi-squared|||Week 8||16.036|-1.417|0.1267
72434911|NCT00383188|144383165|SUPERIORITY||Difference in percentage|5.95|STANDARD_ERROR_OF_MEAN|5.27||0.2069|TWO_SIDED|90.0|-2.72|14.612|||Chi-squared|||Week 8||14.612|-2.720|0.2069
72494129|NCT03237065|144517210|SUPERIORITY||Mean Difference (Final Values)|-24.3||||0.1988|TWO_SIDED|95.0|-62.3|13.7|||Mixed model for repeated measures|||"Day 21~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||13.7|-62.3|0.1988
72382773|NCT01325623|144274280|SUPERIORITY_OR_OTHER|||||||0.1106|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Overall Recovery Score||||0.1106
72382774|NCT01325623|144274280|SUPERIORITY_OR_OTHER|||||||0.1273|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Overall Severity Score||||0.1273
72382775|NCT01325623|144274280|SUPERIORITY_OR_OTHER|||||||0.1305|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Postictal Emotional Recovery Score||||0.1305
72382776|NCT01325623|144274280|SUPERIORITY_OR_OTHER|||||||0.1123|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Postictal Physical Recovery Score||||0.1123
72382777|NCT01325623|144274280|SUPERIORITY_OR_OTHER|||||||0.2309|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Postictal Cognitive Recovery Score||||0.2309
72382778|NCT01325623|144274280|SUPERIORITY_OR_OTHER|||||||0.3191|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||SSQ Total Score||||0.3191
72382779|NCT01325623|144274280|SUPERIORITY_OR_OTHER|||||||0.0679|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Activity During Seizures Score||||0.0679
72382780|NCT01325623|144274280|SUPERIORITY_OR_OTHER|||||||0.2082|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Overall Recovery Score||||0.2082
72382781|NCT01325623|144274280|SUPERIORITY_OR_OTHER|||||||0.179|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Overall Severity Score||||0.1790
72382782|NCT01325623|144274280|SUPERIORITY_OR_OTHER|||||||0.6869|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Postictal Emotional Recovery Score||||0.6869
72382783|NCT01325623|144274280|SUPERIORITY_OR_OTHER|||||||0.6094|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Postictal Physical Recovery Score||||0.6094
72382784|NCT01325623|144274280|SUPERIORITY_OR_OTHER|||||||0.153|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Postictal Cognitive Recovery Score||||0.1530
72382785|NCT01325623|144274280|SUPERIORITY_OR_OTHER|||||||0.3339|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||SSQ Total Score||||0.3339
72382786|NCT01325623|144274280|SUPERIORITY_OR_OTHER|||||||0.1473|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Activity During Seizures Score||||0.1473
72382787|NCT01325623|144274280|SUPERIORITY_OR_OTHER|||||||0.5035|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Overall Recovery Score||||0.5035
72618705|NCT01026038|144768108|SUPERIORITY_OR_OTHER||GMT ratio|0.5|||||TWO_SIDED|95.0|0.2|1.45||||||Serotype 3: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.45|0.20|
72382788|NCT01325623|144274280|SUPERIORITY_OR_OTHER|||||||0.6653|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Overall Severity Score||||0.6653
72382789|NCT01325623|144274280|SUPERIORITY_OR_OTHER|||||||0.8622|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Postictal Emotional Recovery Score||||0.8622
72382790|NCT01325623|144274280|SUPERIORITY_OR_OTHER|||||||0.4456|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Postictal Physical Recovery Score||||0.4456
72382791|NCT01325623|144274280|SUPERIORITY_OR_OTHER|||||||0.6876|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Postictal Cognitive Recovery Score||||0.6876
72382792|NCT01325623|144274280|SUPERIORITY_OR_OTHER|||||||0.0328|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||SSQ Total Score||||0.0328
72382793|NCT01325623|144274280|SUPERIORITY_OR_OTHER|||||||0.0067|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Activity During Seizures Score||||0.0067
72382794|NCT01325623|144274280|SUPERIORITY_OR_OTHER|||||||0.5928|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Overall Recovery Score||||0.5928
72382795|NCT01325623|144274280|SUPERIORITY_OR_OTHER|||||||0.7179|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Overall Severity Score||||0.7179
72382796|NCT01325623|144274280|SUPERIORITY_OR_OTHER|||||||0.5014|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Postictal Emotional Recovery Score||||0.5014
72382797|NCT01325623|144274280|SUPERIORITY_OR_OTHER|||||||0.964|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Postictal Physical Recovery Score||||0.9640
72382798|NCT01325623|144274280|SUPERIORITY_OR_OTHER|||||||0.8537|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Postictal Cognitive Recovery Score||||0.8537
72382799|NCT01325623|144274284|SUPERIORITY_OR_OTHER|||||||0.2079|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||QOLIE Overall Total||||0.2079
72382800|NCT01325623|144274284|SUPERIORITY_OR_OTHER|||||||0.6562|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Energy/Fatigue Final Score||||0.6562
72382801|NCT01325623|144274284|SUPERIORITY_OR_OTHER|||||||0.9376|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Emotional well being Final Score||||0.9376
72382802|NCT01325623|144274284|SUPERIORITY_OR_OTHER|||||||0.01|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Social Functioning Final Score||||0.0100
72382803|NCT01325623|144274284|SUPERIORITY_OR_OTHER|||||||0.8532|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Cognitive functioning Final Score||||0.8532
72382804|NCT01325623|144274284|SUPERIORITY_OR_OTHER|||||||0.4954|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Medication Effects Final Score||||0.4954
72382805|NCT01325623|144274284|SUPERIORITY_OR_OTHER|||||||0.1877|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Seizure Worry Final Score||||0.1877
72382806|NCT01325623|144274284|SUPERIORITY_OR_OTHER|||||||0.4189|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Overall Quality of Life Final Score||||0.4189
72382807|NCT01325623|144274284|SUPERIORITY_OR_OTHER|||||||0.2365|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||QOLIE Overall Total Score||||0.2365
72382808|NCT01325623|144274284|SUPERIORITY_OR_OTHER|||||||0.4138|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Energy/Fatigue Final Score||||0.4138
72382809|NCT01325623|144274284|SUPERIORITY_OR_OTHER|||||||0.8701|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Emotional well being Final Score||||0.8701
72382810|NCT01325623|144274284|SUPERIORITY_OR_OTHER|||||||0.0527|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Social Functioning Final Score||||0.0527
72382811|NCT01325623|144274284|SUPERIORITY_OR_OTHER|||||||0.1353|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Cognitive functioning Final Score||||0.1353
72434912|NCT00383188|144383165|SUPERIORITY||Difference in percentage|1.84|STANDARD_ERROR_OF_MEAN|4.08||0.6506|TWO_SIDED|90.0|-4.871|8.553|||Chi-squared|||Week 12||8.553|-4.871|0.6506
72434913|NCT00383188|144383165|SUPERIORITY||Difference in percentage|2.7|STANDARD_ERROR_OF_MEAN|4.12||0.5125|TWO_SIDED|90.0|-4.075|9.48|||Chi-squared|||Week 12||9.480|-4.075|0.5125
72434914|NCT00383188|144383165|SUPERIORITY||Difference in percentage|3.69|STANDARD_ERROR_OF_MEAN|5.07||0.4412|TWO_SIDED|90.0|-4.652|12.023|||Chi-squared|||Week 12||12.023|-4.652|0.4412
72557693|NCT00205777|144645446|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Percent change at Month 24 in LDL: P value was calculated using ANCOVA.||||<0.001
72434915|NCT00383188|144383165|SUPERIORITY||Difference in percentage|2.09|STANDARD_ERROR_OF_MEAN|4.92||0.6566|TWO_SIDED|90.0|-6.006|10.195|||Chi-squared|||Week 12||10.195|-6.006|0.6566
72557694|NCT00205777|144645446|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Percent change at Month 36 in LDL: P value was calculated using ANCOVA.||||<0.001
72434916|NCT00383188|144383165|SUPERIORITY||Difference in percentage|-5.16|STANDARD_ERROR_OF_MEAN|4.5||0.2634|TWO_SIDED|90.0|-12.57|2.247|||Chi-squared|||Week 16||2.247|-12.57|0.2634
72434917|NCT00383188|144383165|SUPERIORITY||Difference in percentage|-2.86|STANDARD_ERROR_OF_MEAN|4.73||0.546|TWO_SIDED|90.0|-10.63|4.916|||Chi-squared|||Week 16||4.916|-10.63|0.5460
72434918|NCT00383188|144383165|SUPERIORITY||Difference in percentage|-7.37|STANDARD_ERROR_OF_MEAN|4.43||0.1626|TWO_SIDED|90.0|-14.65|-0.086|||Chi-squared|||Week 16||-0.086|-14.65|0.1626
72434919|NCT00383188|144383165|SUPERIORITY||Difference in percentage|-7.37|STANDARD_ERROR_OF_MEAN|4.43||0.1626|TWO_SIDED|90.0|-14.65|-0.086|||Chi-squared|||Week 16||-0.086|-14.65|0.1626
72434920|NCT00383188|144383166|SUPERIORITY||Least Square Mean (LSM) Difference|-0.388|STANDARD_ERROR_OF_MEAN|1.025||0.7053|TWO_SIDED|95.0|-2.4|1.624|||ANCOVA|||Week 1: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 1 as an interaction term, baseline tender/ joint count as the covariate and participant as a random effect.||1.624|-2.400|0.7053
72434921|NCT00383188|144383166|SUPERIORITY||LSM Difference|-1.312|STANDARD_ERROR_OF_MEAN|1.009||0.1938|TWO_SIDED|95.0|-3.291|0.668|||ANCOVA|||Week 1: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 1 as an interaction term, baseline tender/ joint count as the covariate and participant as a random effect.||0.668|-3.291|0.1938
72434922|NCT00383188|144383166|SUPERIORITY||LSM Difference|-2.187|STANDARD_ERROR_OF_MEAN|1.174||0.0627|TWO_SIDED|95.0|-4.491|0.116|||ANCOVA|||Week 1: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 1 as an interaction term, baseline tender/ joint count as the covariate and participant as a random effect.||0.116|-4.491|0.0627
72434923|NCT00383188|144383166|SUPERIORITY||LSM Difference|-0.851|STANDARD_ERROR_OF_MEAN|1.206||0.4809|TWO_SIDED|95.0|-3.218|1.517|||ANCOVA|||Week 1: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 1 as an interaction term, baseline tender/ joint count as the covariate and participant as a random effect.||1.517|-3.218|0.4809
72434924|NCT00383188|144383166|SUPERIORITY||LSM Difference|-1.289|STANDARD_ERROR_OF_MEAN|1.017||0.2057|TWO_SIDED|95.0|-3.286|0.709|||ANCOVA|||Week 2: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 2 as an interaction term, baseline tender/ joint count as the covariate and participant as a random effect.||0.709|-3.286|0.2057
72434925|NCT00383188|144383166|SUPERIORITY||LSM Difference|-1.331|STANDARD_ERROR_OF_MEAN|0.999||0.1833|TWO_SIDED|95.0|-3.293|0.631|||ANCOVA|||Week 2: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 2 as an interaction term, baseline tender/ joint count as the covariate and participant as a random effect.||0.631|-3.293|0.1833
72434926|NCT00383188|144383166|SUPERIORITY||LSM Difference|-2.748|STANDARD_ERROR_OF_MEAN|1.166||0.0187|TWO_SIDED|95.0|-5.037|-0.459|||ANCOVA|||Week 2: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 2 as an interaction term, baseline tender/ joint count as the covariate and participant as a random effect.||-0.459|-5.037|0.0187
72434927|NCT00383188|144383166|SUPERIORITY||LSM Difference|-1.345|STANDARD_ERROR_OF_MEAN|1.197||0.2615|TWO_SIDED|95.0|-3.695|1.005|||ANCOVA|||Week 2: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 2 as an interaction term, baseline tender/ joint count as the covariate and participant as a random effect.||1.005|-3.695|0.2615
72434928|NCT00383188|144383166|SUPERIORITY||LSM Difference|-1.764|STANDARD_ERROR_OF_MEAN|1.017||0.0832|TWO_SIDED|95.0|-3.761|0.233|||ANCOVA|||Week 4: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 4 as an interaction term, baseline tender/ joint count as the covariate and participant as a random effect.||0.233|-3.761|0.0832
72434929|NCT00383188|144383166|SUPERIORITY||LSM Difference|-1.615|STANDARD_ERROR_OF_MEAN|0.999||0.1066|TWO_SIDED|95.0|-3.576|0.347|||ANCOVA|||Week 4: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 4 as an interaction term, baseline tender/ joint count as the covariate and participant as a random effect.||0.347|-3.576|0.1066
72434930|NCT00383188|144383166|SUPERIORITY||LSM Difference|-2.406|STANDARD_ERROR_OF_MEAN|1.166||0.0394|TWO_SIDED|95.0|-4.695|-0.118|||ANCOVA|||Week 4: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 4 as an interaction term, baseline tender/ joint count as the covariate and participant as a random effect.||-0.118|-4.695|0.0394
72504734|NCT03114969|144540498|SUPERIORITY||Odds Ratio (OR)|2.478||||0.114|TWO_SIDED|95.0|0.805|7.632||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator.|||7.632|0.805|0.114
72557695|NCT00205777|144645446|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||ANCOVA|||Percent change at Month 6 in HDL: P value was calculated using ANCOVA.||||0.001
72504735|NCT03114969|144540498|SUPERIORITY||Odds Ratio (OR)|3.499||||0.026|TWO_SIDED|95.0|1.16|10.555||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Incruse/Anoro Ellipta as comparator.|||10.555|1.160|0.026
72557696|NCT00205777|144645446|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Percent change at Month 12 in HDL: P value was calculated using ANCOVA.||||<0.001
72557697|NCT00205777|144645446|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||ANCOVA|||Percent change at Month 24 in HDL: P value was calculated using ANCOVA.||||0.001
72434931|NCT00383188|144383166|SUPERIORITY||LSM Difference|-1.355|STANDARD_ERROR_OF_MEAN|1.197||0.258|TWO_SIDED|95.0|-3.705|0.995|||ANCOVA|||Week 4: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 4 as an interaction term, baseline tender/ joint count as the covariate and participant as a random effect.||0.995|-3.705|0.2580
72434932|NCT00383188|144383166|SUPERIORITY||LSM Difference|-0.758|STANDARD_ERROR_OF_MEAN|1.017||0.456|TWO_SIDED|95.0|-2.754|1.238|||ANCOVA|||Week 8: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 8 as an interaction term, baseline tender/ joint count as the covariate and participant as a random effect.||1.238|-2.754|0.4560
72434933|NCT00383188|144383166|SUPERIORITY||LSM Difference|-2.021|STANDARD_ERROR_OF_MEAN|0.999||0.0434|TWO_SIDED|95.0|-3.982|-0.06|||ANCOVA|||Week 8: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 8 as an interaction term, baseline tender/ joint count as the covariate and participant as a random effect.||-0.060|-3.982|0.0434
72434934|NCT00383188|144383166|SUPERIORITY||LSM Difference|-1.728|STANDARD_ERROR_OF_MEAN|1.165||0.1386|TWO_SIDED|95.0|-4.016|0.56|||ANCOVA|||Week 8: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 8 as an interaction term, baseline tender/ joint count as the covariate and participant as a random effect.||0.560|-4.016|0.1386
72434935|NCT00383188|144383166|SUPERIORITY||LSM Difference|-1.154|STANDARD_ERROR_OF_MEAN|1.197||0.3353|TWO_SIDED|95.0|-3.503|1.196|||ANCOVA|||Week 8: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 8 as an interaction term, baseline tender/ joint count as the covariate and participant as a random effect.||1.196|-3.503|0.3353
72434936|NCT00383188|144383166|SUPERIORITY||LSM Difference|-2.08|STANDARD_ERROR_OF_MEAN|1.016||0.041|TWO_SIDED|95.0|-4.075|-0.085|||ANCOVA|||Week 12: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 12 as an interaction term, baseline tender/ joint count as the covariate and participant as a random effect.||-0.085|-4.075|0.0410
72434937|NCT00383188|144383166|SUPERIORITY||LSM Difference|-2.234|STANDARD_ERROR_OF_MEAN|0.998||0.0255|TWO_SIDED|95.0|-4.194|-0.274|||ANCOVA|||Week 12: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 12 as an interaction term, baseline tender/ joint count as the covariate and participant as a random effect.||-0.274|-4.194|0.0255
72434938|NCT00383188|144383166|SUPERIORITY||LSM Difference|-2.384|STANDARD_ERROR_OF_MEAN|1.165||0.041|TWO_SIDED|95.0|-4.671|-0.097|||ANCOVA|||Week 12: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 12 as an interaction term, baseline tender/ joint count as the covariate and participant as a random effect.||-0.097|-4.671|0.0410
72618706|NCT01026038|144768108|SUPERIORITY_OR_OTHER||GMT ratio|1.0|||||TWO_SIDED|95.0|0.87|1.15||||||Serotype 5: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||1.15|0.87|
72618707|NCT01026038|144768108|SUPERIORITY_OR_OTHER||GMT ratio|0.9|||||TWO_SIDED|95.0|0.79|1.03||||||Serotype 5: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.03|0.79|
72434939|NCT00383188|144383166|SUPERIORITY||LSM Difference|-1.911|STANDARD_ERROR_OF_MEAN|1.196||0.1106|TWO_SIDED|95.0|-4.259|0.438|||ANCOVA|||Week 12: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 12 as an interaction term, baseline tender/ joint count as the covariate and participant as a random effect.||0.438|-4.259|0.1106
72434940|NCT00383188|144383166|SUPERIORITY||LSM Difference|-0.251|STANDARD_ERROR_OF_MEAN|1.048||0.8107|TWO_SIDED|95.0|-2.307|1.805|||ANCOVA|||Week 16: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 16 as an interaction term, baseline tender/ joint count as the covariate and participant as a random effect.||1.805|-2.307|0.8107
72434941|NCT00383188|144383166|SUPERIORITY||LSM Difference|0.272|STANDARD_ERROR_OF_MEAN|1.017||0.7895|TWO_SIDED|95.0|-1.726|2.269|||ANCOVA|||Week 16: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 16 as an interaction term, baseline tender/ joint count as the covariate and participant as a random effect.||2.269|-1.726|0.7895
72434942|NCT00383188|144383166|SUPERIORITY||LSM Difference|-0.306|STANDARD_ERROR_OF_MEAN|1.206||0.7996|TWO_SIDED|95.0|-2.673|2.06|||ANCOVA|||Week 16: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 16 as an interaction term, baseline tender/ joint count as the covariate and participant as a random effect.||2.060|-2.673|0.7996
72494130|NCT03237065|144517210|SUPERIORITY||Mean Difference (Final Values)|11.3||||0.4379|TWO_SIDED|95.0|-18.6|41.2|||Mixed model for repeated measures|||"Day 35~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||41.2|-18.6|0.4379
72494131|NCT03237065|144517211|SUPERIORITY||Mean Difference (Final Values)|-0.18||||0.6869|TWO_SIDED|95.0|-1.06|0.7|||Mixed model for repeated measures|||"Day 1~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||0.70|-1.06|0.6869
72557698|NCT00205777|144645446|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Percent change at Month 36 in HDL: P value was calculated using ANCOVA.||||<0.001
72557699|NCT00205777|144645446|SUPERIORITY_OR_OTHER|||||||0.1||95.0|||||ANCOVA|||Percent change at Month 6 in HDL: P value was calculated using ANCOVA.||||0.10
72618708|NCT01026038|144768108|SUPERIORITY_OR_OTHER||GMT ratio|0.9|||||TWO_SIDED|95.0|0.76|1.06||||||Serotype 5: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.06|0.76|
72618709|NCT01026038|144768108|SUPERIORITY_OR_OTHER||GMT ratio|16.5|||||TWO_SIDED|95.0|3.56|76.14||||||Serotype 6A: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||76.14|3.56|
72618710|NCT01026038|144768108|SUPERIORITY_OR_OTHER||GMT ratio|2.3|||||TWO_SIDED|95.0|0.56|9.06||||||Serotype 6A: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||9.06|0.56|
72618711|NCT01026038|144768108|SUPERIORITY_OR_OTHER||GMT ratio|0.1|||||TWO_SIDED|95.0|0.02|0.78||||||Serotype 6A: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||0.78|0.02|
72618712|NCT01026038|144768108|SUPERIORITY_OR_OTHER||GMT ratio|1.3|||||TWO_SIDED|95.0|0.22|7.07||||||Serotype 7F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||7.07|0.22|
72382812|NCT01325623|144274284|SUPERIORITY_OR_OTHER|||||||0.6927|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Medication Effects Final Score||||0.6927
72382813|NCT01325623|144274284|SUPERIORITY_OR_OTHER|||||||0.4964|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Seizure Worry Final Score||||0.4964
72382814|NCT01325623|144274284|SUPERIORITY_OR_OTHER|||||||0.0238|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Overall Quality of Life Final Score||||0.0238
72382815|NCT01325623|144274284|SUPERIORITY_OR_OTHER|||||||0.0139|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||QOLIE Overall Total Score||||0.0139
72382816|NCT01325623|144274284|SUPERIORITY_OR_OTHER|||||||0.2822|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Energy/Fatigue Final Score||||0.2822
72382817|NCT01325623|144274284|SUPERIORITY_OR_OTHER|||||||0.1363|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Emotional well being Final Score||||0.1363
72382818|NCT01325623|144274284|SUPERIORITY_OR_OTHER|||||||0.0019|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Social Functioning Final Score||||0.0019
72382819|NCT01325623|144274284|SUPERIORITY_OR_OTHER|||||||0.1293|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Cognitive functioning Final Score||||0.1293
72382820|NCT01325623|144274284|SUPERIORITY_OR_OTHER|||||||0.5252|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Medication Effects Final Score||||0.5252
72382821|NCT01325623|144274284|SUPERIORITY_OR_OTHER|||||||0.0642|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Seizure Worry Final Score||||0.0642
72557700|NCT00205777|144645446|SUPERIORITY_OR_OTHER|||||||0.89||95.0|||||ANCOVA|||Percent change at Month 12 in HDL: P value was calculated using ANCOVA.||||0.89
72382822|NCT01325623|144274284|SUPERIORITY_OR_OTHER|||||||0.0025|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Overall Quality of Life Final Score||||0.0025
72382823|NCT01325623|144274284|SUPERIORITY_OR_OTHER|||||||0.0024|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||QOLIE Overall Total Score||||0.0024
72382824|NCT01325623|144274284|SUPERIORITY_OR_OTHER|||||||0.4464|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Energy/Fatigue Final Score||||0.4464
72382825|NCT01325623|144274284|SUPERIORITY_OR_OTHER|||||||0.0511|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Emotional well being Final Score||||0.0511
72382826|NCT01325623|144274284|SUPERIORITY_OR_OTHER|||||||0.0002|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Social Functioning Final Score||||0.0002
72382827|NCT01325623|144274284|SUPERIORITY_OR_OTHER|||||||0.0296|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Cognitive Functioning Final Score||||0.0296
72382828|NCT01325623|144274284|SUPERIORITY_OR_OTHER|||||||0.3115|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Medication Effects Final Score||||0.3115
72382829|NCT01325623|144274284|SUPERIORITY_OR_OTHER|||||||0.027|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Seizure Worry Final Score||||0.0270
72382830|NCT01325623|144274284|SUPERIORITY_OR_OTHER|||||||0.0008|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Overall Quality of Life Final Score||||0.0008
72382831|NCT01325623|144274284|SUPERIORITY_OR_OTHER|||||||0.0683|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||QOLIE Overall Total Score||||0.0683
72382832|NCT01325623|144274284|SUPERIORITY_OR_OTHER|||||||0.2226|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Energy/Fatigue Final Score||||0.2226
72557701|NCT00205777|144645446|SUPERIORITY_OR_OTHER|||||||0.6||95.0|||||ANCOVA|||Percent change at Month 24 in HDL: P value was calculated using ANCOVA.||||0.60
72557702|NCT00205777|144645446|SUPERIORITY_OR_OTHER|||||||0.82||95.0|||||ANCOVA|||Percent change at Month 36 in HDL: P value was calculated using ANCOVA.||||0.82
72557703|NCT00205777|144645446|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||ANCOVA|||Percent change at Month 6 in HDL: P value was calculated using ANCOVA.||||0.001
72557704|NCT00205777|144645446|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Percent change at Month 12 in HDL: P value was calculated using ANCOVA.||||<0.001
72557705|NCT00205777|144645446|SUPERIORITY_OR_OTHER|||||||0.012||95.0|||||ANCOVA|||Percent change at Month 24 in HDL: P value was calculated using ANCOVA.||||0.012
72557706|NCT00205777|144645446|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Percent change at Month 36 in HDL: P value was calculated using ANCOVA.||||<0.001
72557707|NCT00205777|144645446|SUPERIORITY_OR_OTHER|||||||0.083||95.0|||||ANCOVA|||Percent change at Month 6 in HDL: P value was calculated using ANCOVA.||||0.083
72557708|NCT00205777|144645446|SUPERIORITY_OR_OTHER|||||||0.96||95.0|||||ANCOVA|||Percent change at Month 12 in HDL: P value was calculated using ANCOVA.||||0.96
72557709|NCT00205777|144645446|SUPERIORITY_OR_OTHER|||||||0.84||95.0|||||ANCOVA|||Percent change at Month 24 in HDL: P value was calculated using ANCOVA.||||0.84
72382833|NCT01325623|144274284|SUPERIORITY_OR_OTHER|||||||0.0823|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Emotional well being Final Score||||0.0823
72382834|NCT01325623|144274284|SUPERIORITY_OR_OTHER|||||||0.1459|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Social Functioning Final Score||||0.1459
72382835|NCT01325623|144274284|SUPERIORITY_OR_OTHER|||||||0.261|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Cognitive Functioning Final Score||||0.2610
72557710|NCT00205777|144645446|SUPERIORITY_OR_OTHER|||||||0.15||95.0|||||ANCOVA|||Percent change at Month 36 in HDL: P value was calculated using ANCOVA.||||0.15
72382836|NCT01325623|144274284|SUPERIORITY_OR_OTHER|||||||0.9119|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||||||0.9119
72382837|NCT01325623|144274284|SUPERIORITY_OR_OTHER|||||||0.0826|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Seizure Worry Final Score||||0.0826
72382838|NCT01325623|144274284|SUPERIORITY_OR_OTHER|||||||0.0036|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Overall Quality of Life Final Score||||0.0036
72557711|NCT00205777|144645446|SUPERIORITY_OR_OTHER|||||||0.13||95.0|||||ANCOVA|||Percent change at Month 6 in HDL: P value was calculated using ANCOVA.||||0.13
72557712|NCT00205777|144645446|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Percent change at Month 12 in HDL: P value was calculated using ANCOVA.||||<0.001
72557713|NCT00205777|144645446|SUPERIORITY_OR_OTHER|||||||0.007||95.0|||||ANCOVA|||Percent change at Month 24 in HDL: P value was calculated using ANCOVA.||||0.007
72557714|NCT00205777|144645446|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Percent change at Month 36 in HDL: P value was calculated using ANCOVA.||||<0.001
72557715|NCT00205777|144645446|SUPERIORITY_OR_OTHER|||||||0.28||95.0|||||ANCOVA|||Percent change at Month 6 in HDL2: P value was calculated using ANCOVA.||||0.28
72557716|NCT00205777|144645446|SUPERIORITY_OR_OTHER|||||||0.1||95.0|||||ANCOVA|||Percent change at Month 12 in HDL2: P value was calculated using ANCOVA||||0.10
72557717|NCT00205777|144645446|SUPERIORITY_OR_OTHER|||||||0.94||95.0|||||ANCOVA|||Percent change at Month 24 in HDL2: P value was calculated using ANCOVA.||||0.94
72557718|NCT00205777|144645446|SUPERIORITY_OR_OTHER|||||||0.46||95.0|||||ANCOVA|||Percent change at Month 36 in HDL2: P value was calculated using ANCOVA.||||0.46
72557719|NCT00205777|144645446|SUPERIORITY_OR_OTHER|||||||0.63||95.0|||||ANCOVA|||Percent change at Month 6 in HDL2: P value was calculated using ANCOVA.||||0.63
72557720|NCT00205777|144645446|SUPERIORITY_OR_OTHER|||||||0.7||95.0|||||ANCOVA|||Percent change at Month 12 in HDL2: P value was calculated using ANCOVA.||||0.70
72557721|NCT00205777|144645446|SUPERIORITY_OR_OTHER|||||||0.58||95.0|||||ANCOVA|||Percent change at Month 24 in HDL2: P value was calculated using ANCOVA.||||0.58
72557722|NCT00205777|144645446|SUPERIORITY_OR_OTHER|||||||0.29||95.0|||||ANCOVA|||Percent change at Month 36 in HDL2: P value was calculated using ANCOVA.||||0.29
72557723|NCT00205777|144645446|SUPERIORITY_OR_OTHER|||||||0.59||95.0|||||ANCOVA|||Percent change at Month 6 in HDL2: P value was calculated using ANCOVA.||||0.59
72557724|NCT00205777|144645446|SUPERIORITY_OR_OTHER|||||||0.036||95.0|||||ANCOVA|||Percent change at Month 12 in HDL2: P value was calculated using ANCOVA.||||0.036
72557725|NCT00205777|144645446|SUPERIORITY_OR_OTHER|||||||0.57||95.0|||||ANCOVA|||Percent change at Month 24 in HDL2: P value was calculated using ANCOVA.||||0.57
72557726|NCT00205777|144645446|SUPERIORITY_OR_OTHER|||||||0.49||95.0|||||ANCOVA|||Percent change at Month 36 in HDL2: P value was calculated using ANCOVA.||||0.49
72557727|NCT00205777|144645446|SUPERIORITY_OR_OTHER|||||||0.038||95.0|||||ANCOVA|||Percent change at Month 6 in HDL2: P value was calculated using ANCOVA.||||0.038
72557728|NCT00205777|144645446|SUPERIORITY_OR_OTHER|||||||0.93||95.0|||||ANCOVA|||Percent change at Month 12 in HDL2: P value was calculated using ANCOVA.||||0.93
72557729|NCT00205777|144645446|SUPERIORITY_OR_OTHER|||||||0.96||95.0|||||ANCOVA|||Percent change at Month 24 in HDL2: P value was calculated using ANCOVA.||||0.96
72557730|NCT00205777|144645446|SUPERIORITY_OR_OTHER|||||||0.72||95.0|||||ANCOVA|||Percent change at Month 36 in HDL2: P value was calculated using ANCOVA.||||0.72
72557731|NCT00205777|144645446|SUPERIORITY_OR_OTHER|||||||0.12||95.0|||||ANCOVA|||Percent change at Month 6 in HDL2: P value was calculated using ANCOVA.||||0.12
72557732|NCT00205777|144645446|SUPERIORITY_OR_OTHER|||||||0.043||95.0|||||ANCOVA|||Percent change at Month 12 in HDL2: P value was calculated using ANCOVA.||||0.043
72557733|NCT00205777|144645446|SUPERIORITY_OR_OTHER|||||||0.53||95.0|||||ANCOVA|||Percent change at Month 24 in HDL2: P value was calculated using ANCOVA.||||0.53
72557734|NCT00205777|144645446|SUPERIORITY_OR_OTHER|||||||0.75||95.0|||||ANCOVA|||Percent change at Month 36 in HDL2: P value was calculated using ANCOVA.||||0.75
72557735|NCT00205777|144645446|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Percent change at Month 6 in HDL3: P value was calculated using ANCOVA.||||<0.001
72557736|NCT00205777|144645446|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Percent change at Month 12 in HDL3: P value was calculated using ANCOVA.||||<0.001
72557737|NCT00205777|144645446|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Percent change at Month 24 in HDL3: P value was calculated using ANCOVA.||||<0.001
72557738|NCT00205777|144645446|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Percent change at Month 36 in HDL3: P value was calculated using ANCOVA.||||<0.001
72557739|NCT00205777|144645446|SUPERIORITY_OR_OTHER|||||||0.46||95.0|||||ANCOVA|||Percent change at Month 6 in HDL3: P value was calculated using ANCOVA.||||0.46
72557740|NCT00205777|144645446|SUPERIORITY_OR_OTHER|||||||0.64||95.0|||||ANCOVA|||Percent change at Month 12 in HDL3: P value was calculated using ANCOVA.||||0.64
72494132|NCT03237065|144517211|SUPERIORITY||Mean Difference (Final Values)|-1.04||||0.1037|TWO_SIDED|95.0|-2.29|0.22|||Mixed model for repeated measures|||"Day 7~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||0.22|-2.29|0.1037
72494133|NCT03237065|144517211|SUPERIORITY||Mean Difference (Final Values)|-1.62||||0.0213|TWO_SIDED|95.0|-2.99|-0.25|||Mixed model for repeated measures|||"Day 8~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||-0.25|-2.99|0.0213
72494134|NCT03237065|144517211|SUPERIORITY||Mean Difference (Final Values)|-1.91||||0.0176|TWO_SIDED|95.0|-3.47|-0.34|||Mixed model for repeated measures|||"Day 14~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||-0.34|-3.47|0.0176
72494135|NCT03237065|144517211|SUPERIORITY||Mean Difference (Final Values)|-1.37||||0.0999|TWO_SIDED|95.0|-3.01|0.27|||Mixed model for repeated measures|||"Day 21~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||0.27|-3.01|0.0999
72494136|NCT03237065|144517211|SUPERIORITY||Mean Difference (Final Values)|0.14||||0.8878|TWO_SIDED|95.0|-1.77|2.04|||Mixed model for repeated measures|||"Day 35~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||2.04|-1.77|0.8878
72494137|NCT03237065|144517212|SUPERIORITY||Mean Difference (Final Values)|21.81|||<|0.0001|TWO_SIDED|95.0|17.66|25.95|||Mixed model for repeated measures|||"Day 1~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||25.95|17.66|<0.0001
72557741|NCT00205777|144645446|SUPERIORITY_OR_OTHER|||||||0.47||95.0|||||ANCOVA|||Percent change at Month 24 in HDL3: P value was calculated using ANCOVA.||||0.47
72557742|NCT00205777|144645446|SUPERIORITY_OR_OTHER|||||||0.75||95.0|||||ANCOVA|||Percent change at Month 36 in HDL3: P value was calculated using ANCOVA.||||0.75
72557743|NCT00205777|144645446|SUPERIORITY_OR_OTHER|||||||0.003||95.0|||||ANCOVA|||Percent change at Month 6 in HDL3: P value was calculated using ANCOVA.||||0.003
72557744|NCT00205777|144645446|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Percent change at Month 12 in HDL3: P value was calculated using ANCOVA.||||<0.001
72557745|NCT00205777|144645446|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Percent change at Month 24 in HDL3: P value was calculated using ANCOVA.||||<0.001
72557746|NCT00205777|144645446|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Percent change at Month 36 in HDL3: P value was calculated using ANCOVA.||||<0.001
72557747|NCT00205777|144645446|SUPERIORITY_OR_OTHER|||||||0.81||95.0|||||ANCOVA|||Percent change at Month 6 in HDL3: P value was calculated using ANCOVA.||||0.81
72557748|NCT00205777|144645446|SUPERIORITY_OR_OTHER|||||||0.98||95.0|||||ANCOVA|||Percent change at Month 12 in HDL3: P value was calculated using ANCOVA.||||0.98
72557749|NCT00205777|144645446|SUPERIORITY_OR_OTHER|||||||0.87||95.0|||||ANCOVA|||Percent change at Month 24 in HDL3: P value was calculated using ANCOVA.||||0.87
72557750|NCT00205777|144645446|SUPERIORITY_OR_OTHER|||||||0.4||95.0|||||ANCOVA|||Percent change at Month 36 in HDL3: P value was calculated using ANCOVA.||||0.40
72557751|NCT00205777|144645446|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||ANCOVA|||Percent change at Month 6 in HDL3: P value was calculated using ANCOVA.||||0.001
72557752|NCT00205777|144645446|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Percent change at Month 12 in HDL3: P value was calculated using ANCOVA.||||<0.001
72557753|NCT00205777|144645446|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Percent change at Month 24 in HDL3: P value was calculated using ANCOVA.||||<0.001
72557754|NCT00205777|144645446|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Percent change at Month 36 in HDL3: P value was calculated using ANCOVA.||||<0.001
72557755|NCT00205777|144645446|SUPERIORITY_OR_OTHER|||||||0.85||95.0|||||ANCOVA|||Percent change at Month 6 in Triglycerides: P value was calculated using ANCOVA.||||0.85
72557756|NCT00205777|144645446|SUPERIORITY_OR_OTHER|||||||0.26||95.0|||||ANCOVA|||Percent change at Month 12 in Triglycerides: P value was calculated using ANCOVA.||||0.26
72557757|NCT00205777|144645446|SUPERIORITY_OR_OTHER|||||||0.33||95.0|||||ANCOVA|||Percent change at Month 24 in Triglycerides: P value was calculated using ANCOVA.||||0.33
72557758|NCT00205777|144645446|SUPERIORITY_OR_OTHER|||||||0.22||95.0|||||ANCOVA|||Percent change at Month 36 in Triglycerides: P value was calculated using ANCOVA.||||0.22
72557759|NCT00205777|144645446|SUPERIORITY_OR_OTHER|||||||0.86||95.0|||||ANCOVA|||Percent change at Month 6 in Triglycerides: P value was calculated using ANCOVA.||||0.86
72557760|NCT00205777|144645446|SUPERIORITY_OR_OTHER|||||||0.65||95.0|||||ANCOVA|||Percent change at Month 12 in Triglycerides: P value was calculated using ANCOVA.||||0.65
72557761|NCT00205777|144645446|SUPERIORITY_OR_OTHER|||||||1||95.0|||||ANCOVA|||Percent change at Month 24 in Triglycerides: P value was calculated using ANCOVA.||||1.00
72557762|NCT00205777|144645446|SUPERIORITY_OR_OTHER|||||||0.44||95.0|||||ANCOVA|||Percent change at Month 36 in Triglycerides: P value was calculated using ANCOVA.||||0.44
72557763|NCT00205777|144645446|SUPERIORITY_OR_OTHER|||||||0.058||95.0|||||ANCOVA|||Percent change at Month 6 in Triglycerides: P value was calculated using ANCOVA.||||0.058
72557764|NCT00205777|144645446|SUPERIORITY_OR_OTHER|||||||0.55||95.0|||||ANCOVA|||Percent change at Month 12 in Triglycerides: P value was calculated using ANCOVA.||||0.55
72557765|NCT00205777|144645446|SUPERIORITY_OR_OTHER|||||||0.34||95.0|||||ANCOVA|||Percent change at Month 24 in Triglycerides: P value was calculated using ANCOVA.||||0.34
72557766|NCT00205777|144645446|SUPERIORITY_OR_OTHER|||||||0.96||95.0|||||ANCOVA|||Percent change at Month 36 in Triglycerides: P value was calculated using ANCOVA.||||0.96
72557767|NCT00205777|144645446|SUPERIORITY_OR_OTHER|||||||0.058||95.0|||||ANCOVA|||Percent change at Month 6 in Triglycerides: P value was calculated using ANCOVA.||||0.058
72557768|NCT00205777|144645446|SUPERIORITY_OR_OTHER|||||||0.031||95.0|||||ANCOVA|||Percent change at Month 12 in Triglycerides: P value was calculated using ANCOVA.||||0.031
72557769|NCT00205777|144645446|SUPERIORITY_OR_OTHER|||||||0.054||95.0|||||ANCOVA|||Percent change at Month 24 in Triglycerides: P value was calculated using ANCOVA.||||0.054
72557770|NCT00205777|144645446|SUPERIORITY_OR_OTHER|||||||0.62||95.0|||||ANCOVA|||Percent change at Month 36 in Triglycerides: P value was calculated using ANCOVA.||||0.62
72557771|NCT00205777|144645446|SUPERIORITY_OR_OTHER|||||||0.99||95.0|||||ANCOVA|||Percent change at Month 6 in Triglycerides: P value was calculated using ANCOVA.||||0.99
72618713|NCT01026038|144768108|SUPERIORITY_OR_OTHER||GMT ratio|0.2|||||TWO_SIDED|95.0|0.03|0.74||||||Serotype 7F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||0.74|0.03|
72557772|NCT00205777|144645446|SUPERIORITY_OR_OTHER|||||||0.11||95.0|||||ANCOVA|||Percent change at Month 12 in Triglycerides: P value was calculated using ANCOVA.||||0.11
72557773|NCT00205777|144645446|SUPERIORITY_OR_OTHER|||||||0.33||95.0|||||ANCOVA|||Percent change at Month 24 in Triglycerides: P value was calculated using ANCOVA.||||0.33
72557774|NCT00205777|144645446|SUPERIORITY_OR_OTHER|||||||0.65||95.0|||||ANCOVA|||Percent change at Month 36 in Triglycerides: P value was calculated using ANCOVA.||||0.65
72557775|NCT00205777|144645447|SUPERIORITY_OR_OTHER|||||||0.97|||||||ANOVA|||BV: P value was calculated using Analysis of Variance (ANOVA).||||0.97
72557776|NCT00205777|144645447|SUPERIORITY_OR_OTHER|||||||0.19|TWO_SIDED||||||ANOVA|||BV: P value was calculated using ANOVA.||||0.19
72557777|NCT00205777|144645447|SUPERIORITY_OR_OTHER|||||||0.74|TWO_SIDED||||||ANOVA|||BV: P value was calculated using ANOVA.||||0.74
72557778|NCT00205777|144645447|SUPERIORITY_OR_OTHER|||||||0.79|TWO_SIDED||||||ANOVA|||BV: P value was calculated using ANOVA.||||0.79
72557779|NCT00205777|144645447|SUPERIORITY_OR_OTHER|||||||0.11|||||||ANOVA|||BV: P value was calculated using ANOVA.||||0.11
72557780|NCT00205777|144645447|SUPERIORITY_OR_OTHER|||||||0.78|||||||ANOVA|||OV: P value was calculated using ANOVA.||||0.78
72557781|NCT00205777|144645447|SUPERIORITY_OR_OTHER|||||||0.9|||||||ANOVA|||OV: P value was calculated using ANOVA.||||0.90
72557782|NCT00205777|144645447|SUPERIORITY_OR_OTHER|||||||0.33|||||||ANOVA|||OV: P value was calculated using ANOVA.||||0.33
72557783|NCT00205777|144645447|SUPERIORITY_OR_OTHER|||||||0.51|||||||ANOVA|||OV: P value was calculated using ANOVA.||||0.51
72557784|NCT00205777|144645447|SUPERIORITY_OR_OTHER|||||||0.28|||||||ANOVA|||OV: P value was calculated using ANOVA.||||0.28
72557785|NCT00205777|144645447|SUPERIORITY_OR_OTHER|||||||0.86|||||||ANOVA|||OS: P value was calculated using ANOVA.||||0.86
72557786|NCT00205777|144645447|SUPERIORITY_OR_OTHER|||||||0.6|||||||ANOVA|||OS: P value was calculated using ANOVA.||||0.60
72557787|NCT00205777|144645447|SUPERIORITY_OR_OTHER|||||||0.84|||||||ANOVA|||OS: P value was calculated using ANOVA.||||0.84
72557788|NCT00205777|144645447|SUPERIORITY_OR_OTHER|||||||0.98|||||||ANOVA|||OS: P value was calculated using ANOVA.||||0.98
72557789|NCT00205777|144645447|SUPERIORITY_OR_OTHER|||||||0.47|||||||ANOVA|||OS: P value was calculated using ANOVA.||||0.47
72557790|NCT00205777|144645447|SUPERIORITY_OR_OTHER|||||||0.59|||||||ANOVA|||OcS: P value was calculated using ANOVA.||||0.59
72557791|NCT00205777|144645447|SUPERIORITY_OR_OTHER|||||||0.13|||||||ANOVA|||OcS: P value was calculated using ANOVA.||||0.13
72557792|NCT00205777|144645447|SUPERIORITY_OR_OTHER|||||||0.65|||||||ANOVA|||OcS: P value was calculated using ANOVA.||||0.65
72557793|NCT00205777|144645447|SUPERIORITY_OR_OTHER|||||||0.33|||||||ANOVA|||OcS: P value was calculated using ANOVA.||||0.33
72557794|NCT00205777|144645447|SUPERIORITY_OR_OTHER|||||||0.053|||||||ANOVA|||OcS: P value was calculated using ANOVA.||||0.053
72557795|NCT00205777|144645447|SUPERIORITY_OR_OTHER|||||||0.51|||||||ANOVA|||ObS: P value was calculated using ANOVA.||||0.51
72557796|NCT00205777|144645447|SUPERIORITY_OR_OTHER|||||||0.5|||||||ANOVA|||ObS: P value was calculated using ANOVA.||||0.50
72557797|NCT00205777|144645447|SUPERIORITY_OR_OTHER|||||||0.27|||||||ANOVA|||ObS: P value was calculated using ANOVA.||||0.27
72557798|NCT00205777|144645447|SUPERIORITY_OR_OTHER|||||||0.091|||||||ANOVA|||ObS: P value was calculated using ANOVA.||||0.091
72557799|NCT00205777|144645447|SUPERIORITY_OR_OTHER|||||||0.087|||||||ANOVA|||ObS: P value was calculated using ANOVA.||||0.087
72557800|NCT00205777|144645447|SUPERIORITY_OR_OTHER|||||||0.82|||||||ANOVA|||MS: P value was calculated using ANOVA.||||0.82
72557801|NCT00205777|144645447|SUPERIORITY_OR_OTHER|||||||0.82|||||||ANOVA|||MS: P value was calculated using ANOVA.||||0.82
72434943|NCT00383188|144383166|SUPERIORITY||LSM Difference|0.185|STANDARD_ERROR_OF_MEAN|1.235||0.8811|TWO_SIDED|95.0|-2.24|2.61|||ANCOVA|||Week 16: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 16 as an interaction term, baseline tender/ joint count as the covariate and participant as a random effect.||2.610|-2.240|0.8811
72434944|NCT00383188|144383167|SUPERIORITY||LSM Difference|-0.687|STANDARD_ERROR_OF_MEAN|0.886||0.4385|TWO_SIDED|95.0|-2.427|1.053|||ANCOVA|||Week 1: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 1 as an interaction term, baseline tender/ joint count as the covariate and participant as a random effect.||1.053|-2.427|0.4385
72434945|NCT00383188|144383167|SUPERIORITY||LSM Difference|-1.085|STANDARD_ERROR_OF_MEAN|0.87||0.2131|TWO_SIDED|95.0|-2.794|0.624|||ANCOVA|||Week 1: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 1 as an interaction term, baseline tender/ joint count as the covariate and participant as a random effect.||0.624|-2.794|0.2131
72434946|NCT00383188|144383167|SUPERIORITY||LSM Difference|-1.57|STANDARD_ERROR_OF_MEAN|1.013||0.1216|TWO_SIDED|95.0|-3.559|0.419|||ANCOVA|||Week 1: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 1 as an interaction term, baseline tender/ joint count as the covariate and participant as a random effect.||0.419|-3.559|0.1216
72434947|NCT00383188|144383167|SUPERIORITY||LSM Difference|-0.675|STANDARD_ERROR_OF_MEAN|1.046||0.519|TWO_SIDED|95.0|-2.728|1.378|||ANCOVA|||Week 1: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 1 as an interaction term, baseline tender/ joint count as the covariate and participant as a random effect.||1.378|-2.728|0.5190
72434948|NCT00383188|144383167|SUPERIORITY||LSM Difference|-1.464|STANDARD_ERROR_OF_MEAN|0.88||0.0967|TWO_SIDED|95.0|-3.193|0.264|||ANCOVA|||Week 2: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 2 as an interaction term, baseline swollen joint count as the covariate and participant as a random effect.||0.264|-3.193|0.0967
72434949|NCT00383188|144383167|SUPERIORITY||LSM Difference|-1.027|STANDARD_ERROR_OF_MEAN|0.863||0.2346|TWO_SIDED|95.0|-2.721|0.668|||ANCOVA|||Week 2: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 2 as an interaction term, baseline swollen joint count as the covariate and participant as a random effect.||0.668|-2.721|0.2346
72618714|NCT01026038|144768108|SUPERIORITY_OR_OTHER||GMT ratio|0.1|||||TWO_SIDED|95.0|0.02|0.84||||||Serotype 7F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||0.84|0.02|
72434950|NCT00383188|144383167|SUPERIORITY||LSM Difference|-1.658|STANDARD_ERROR_OF_MEAN|1.007||0.1|TWO_SIDED|95.0|-3.635|0.318|||ANCOVA|||Week 2: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 2 as an interaction term, baseline swollen joint count as the covariate and participant as a random effect.||0.318|-3.635|0.1000
72434951|NCT00383188|144383167|SUPERIORITY||LSM Difference|-0.805|STANDARD_ERROR_OF_MEAN|1.038||0.4385|TWO_SIDED|95.0|-2.844|1.234|||ANCOVA|||Week 2: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 2 as an interaction term, baseline swollen joint count as the covariate and participant as a random effect.||1.234|-2.844|0.4385
72434952|NCT00383188|144383167|SUPERIORITY||LSM Difference|-1.599|STANDARD_ERROR_OF_MEAN|0.88||0.0696|TWO_SIDED|95.0|-3.327|0.128|||ANCOVA|||Week 4: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 4 as an interaction term, baseline swollen joint count as the covariate and participant as a random effect.||0.128|-3.327|0.0696
72434953|NCT00383188|144383167|SUPERIORITY||LSM Difference|-1.6|STANDARD_ERROR_OF_MEAN|0.863||0.0642|TWO_SIDED|95.0|-3.294|0.094|||ANCOVA|||Week 4: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 4 as an interaction term, baseline swollen joint count as the covariate and participant as a random effect.||0.094|-3.294|0.0642
72434954|NCT00383188|144383167|SUPERIORITY||LSM Difference|-1.83|STANDARD_ERROR_OF_MEAN|1.007||0.0695|TWO_SIDED|95.0|-3.807|0.146|||ANCOVA|||Week 4: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 4 as an interaction term, baseline swollen joint count as the covariate and participant as a random effect.||0.146|-3.807|0.0695
72494138|NCT03237065|144517212|SUPERIORITY||Mean Difference (Final Values)|4.64||||0.2923|TWO_SIDED|95.0|-4.05|13.33|||Mixed model for repeated measures|||"Day 7~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||13.33|-4.05|0.2923
72494139|NCT03237065|144517212|SUPERIORITY||Mean Difference (Final Values)|19.56|||<|0.0001|TWO_SIDED|95.0|12.37|26.74|||Mixed model for repeated measures|||"Day 8~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||26.74|12.37|<0.0001
72494140|NCT03237065|144517212|SUPERIORITY||Mean Difference (Final Values)|33.05|||<|0.0001|TWO_SIDED|95.0|25.96|40.14|||Mixed model for repeated measures|||"Day 14~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||40.14|25.96|<0.0001
72557802|NCT00205777|144645447|SUPERIORITY_OR_OTHER|||||||0.12|||||||ANOVA|||MS: P value was calculated using ANOVA.||||0.12
72494141|NCT03237065|144517212|SUPERIORITY||Mean Difference (Final Values)|21.82|||<|0.0001|TWO_SIDED|95.0|14.2|29.43|||Mixed model for repeated measures|||"Day 21~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||29.43|14.20|<0.0001
72494142|NCT03237065|144517212|SUPERIORITY||Mean Difference (Final Values)|9.03||||0.025|TWO_SIDED|95.0|1.16|16.9|||Mixed model for repeated measures|||"Day 35~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||16.90|1.16|0.0250
72494143|NCT03237065|144517213|SUPERIORITY||Mean Difference (Final Values)|-0.06||||0.5134|TWO_SIDED|95.0|-0.22|0.11|||Mixed model for repeated measures|||"Day 1~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||0.11|-0.22|0.5134
72494144|NCT03237065|144517213|SUPERIORITY||Mean Difference (Final Values)|0.04||||0.7579|TWO_SIDED|95.0|-0.24|0.32|||Mixed model for repeated measures|||"Day 7~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||0.32|-0.24|0.7579
72494145|NCT03237065|144517213|SUPERIORITY||Mean Difference (Final Values)|-0.14||||0.3169|TWO_SIDED|95.0|-0.41|0.14|||Mixed model for repeated measures|||"Day 8~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||0.14|-0.41|0.3169
72494146|NCT03237065|144517213|SUPERIORITY||Mean Difference (Final Values)|-0.47||||0.0018|TWO_SIDED|95.0|-0.76|-0.18|||Mixed model for repeated measures|||"Day 14~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||-0.18|-0.76|0.0018
72494147|NCT03237065|144517213|SUPERIORITY||Mean Difference (Final Values)|-0.5||||0.0003|TWO_SIDED|95.0|-0.77|-0.24|||Mixed model for repeated measures|||"Day 21~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||-0.24|-0.77|0.0003
72382839|NCT00145600|144274287|SUPERIORITY_OR_OTHER_LEGACY||KM Event-free survival estimate|0.886|||||TWO_SIDED|95.0|0.82|0.953||||||||0.953|0.820|
72382840|NCT00145600|144274287|SUPERIORITY_OR_OTHER_LEGACY||KM event-free survival estimate|0.844|||||TWO_SIDED|95.0|0.739|0.95||||||||0.950|0.739|
72382841|NCT00145600|144274287|SUPERIORITY_OR_OTHER_LEGACY||KM event-free survival estimate|0.667|||||TWO_SIDED|95.0|0.4|0.933||||||||0.933|0.400|
72382842|NCT00145600|144274287|SUPERIORITY_OR_OTHER_LEGACY||KM event-free survival estimate|0.793|||||TWO_SIDED|95.0|0.726|0.86||||||||0.860|0.726|
72382843|NCT00145600|144274288|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3097||95.0|||||Wilcoxon signed rank test|||||||0.3097
72382844|NCT00145600|144274288|SUPERIORITY_OR_OTHER_LEGACY||Spearman Correlation Coefficients|0.6|||<|0.0001||95.0|||||Spearman Correlation Coefficients|||||||<0.0001
72382845|NCT00145600|144274288|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||Wilcoxon signed rank test|||||||<0.0001
72382846|NCT00145600|144274288|SUPERIORITY_OR_OTHER_LEGACY||Spearman Correlation Coefficients|0.5|||<|0.0001||95.0|||||Spearman Correlation Coefficients|||||||<0.0001
72382847|NCT00145600|144274288|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||Wilcoxon signed rank test|||||||<0.0001
72382848|NCT00145600|144274288|SUPERIORITY_OR_OTHER_LEGACY||Spearman Correlation Coefficients|0.37|||<|0.0001||95.0|||||Spearman Correlation Coefficients|||||||<0.0001
72382849|NCT00145600|144274288|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0197||95.0|||||Wilcoxon signed rank test|||||||0.0197
72494148|NCT03237065|144517213|SUPERIORITY||Mean Difference (Final Values)|-0.23||||0.1063|TWO_SIDED|95.0|-0.5|0.05|||Mixed model for repeated measures|||"Day 35~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||0.05|-0.50|0.1063
72494149|NCT03237065|144517214|SUPERIORITY||Mean Difference (Final Values)|4.57||||0.2166|TWO_SIDED|95.0|-2.72|11.85|||Mixed model for repeated measures|||"Day 1~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||11.85|-2.72|0.2166
72504736|NCT03114969|144540498|SUPERIORITY||Odds Ratio (OR)|3.943||||0.012|TWO_SIDED|95.0|1.348|11.534||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Incruse/Anoro Ellipta as comparator.|||11.534|1.348|0.012
72557803|NCT00205777|144645447|SUPERIORITY_OR_OTHER|||||||0.085|||||||ANOVA|||MS: P value was calculated using ANOVA.||||0.085
72557804|NCT00205777|144645447|SUPERIORITY_OR_OTHER|||||||0.08|||||||ANOVA|||MS: P value was calculated using ANOVA.||||0.080
72557805|NCT00205777|144645447|SUPERIORITY_OR_OTHER|||||||0.24|||||||ANOVA|||ES: P value was calculated using ANOVA.||||0.24
72557806|NCT00205777|144645447|SUPERIORITY_OR_OTHER|||||||0.035|||||||ANOVA|||ES: P value was calculated using ANOVA.||||0.035
72557807|NCT00205777|144645447|SUPERIORITY_OR_OTHER|||||||0.024|||||||ANOVA|||ES: P value was calculated using ANOVA.||||0.024
72557808|NCT00205777|144645447|SUPERIORITY_OR_OTHER|||||||0.3|||||||ANOVA|||ES: P value was calculated using ANOVA.||||0.30
72557809|NCT00205777|144645447|SUPERIORITY_OR_OTHER|||||||0.89|||||||ANOVA|||ES: P value was calculated using ANOVA.||||0.89
72557810|NCT00205777|144645447|SUPERIORITY_OR_OTHER|||||||0.8|||||||ANOVA|||OMS: P value was calculated using ANOVA.||||0.80
72618715|NCT01026038|144768108|SUPERIORITY_OR_OTHER||GMT ratio|4.8|||||TWO_SIDED|95.0|1.35|16.98||||||Serotype 19A: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||16.98|1.35|
72382850|NCT00145600|144274288|SUPERIORITY_OR_OTHER_LEGACY||Spearman Correlation Coefficients|0.51|||<|0.0001||95.0|||||Spearman Correlation Coefficients|||||||<0.0001
72557811|NCT00205777|144645447|SUPERIORITY_OR_OTHER|||||||0.75|||||||ANOVA|||OMS: P value was calculated using ANOVA.||||0.75
72557812|NCT00205777|144645447|SUPERIORITY_OR_OTHER|||||||0.06|||||||ANOVA|||OMS: P value was calculated using ANOVA.||||0.060
72557813|NCT00205777|144645447|SUPERIORITY_OR_OTHER|||||||0.12|||||||ANOVA|||OMS: P value was calculated using ANOVA.||||0.12
72557814|NCT00205777|144645447|SUPERIORITY_OR_OTHER|||||||0.13|||||||ANOVA|||OMS: P value was calculated using ANOVA.||||0.13
72557815|NCT00205777|144645447|SUPERIORITY_OR_OTHER|||||||0.78|||||||ANOVA|||CP: P value was calculated using ANOVA.||||0.78
72557816|NCT00205777|144645447|SUPERIORITY_OR_OTHER|||||||0.7|||||||ANOVA|||CP: P value was calculated using ANOVA.||||0.70
72382851|NCT00145600|144274289|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||Wilcoxon signed rank test|||||||<0.0001
72382852|NCT00145600|144274289|SUPERIORITY_OR_OTHER_LEGACY||Spearman Correlation Coefficients|0.46|||<|0.0001||95.0|||||Spearman Correlation Coefficients|||||||<0.0001
72382853|NCT00145600|144274289|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0001||95.0|||||Wilcoxon signed rank test|||||||0.0001
72557817|NCT00205777|144645447|SUPERIORITY_OR_OTHER|||||||0.98|||||||ANOVA|||CP: P value was calculated using ANOVA.||||0.98
72557818|NCT00205777|144645447|SUPERIORITY_OR_OTHER|||||||0.76||95.0|||||ANOVA|||CP: P value was calculated using ANOVA.||||0.76
72557819|NCT00205777|144645447|SUPERIORITY_OR_OTHER|||||||0.73|||||||ANOVA|||CP: P value was calculated using ANOVA.||||0.73
72557820|NCT00205777|144645448|SUPERIORITY_OR_OTHER|||||||0.7|||||||ANOVA|||BV: P value was calculated using ANOVA.||||0.70
72557821|NCT00205777|144645448|SUPERIORITY_OR_OTHER|||||||0.65|||||||ANOVA|||BV: P value was calculated using ANOVA.||||0.65
72557822|NCT00205777|144645448|SUPERIORITY_OR_OTHER|||||||0.006|||||||ANOVA|||OV: P value was calculated using ANOVA.||||0.006
72557823|NCT00205777|144645448|SUPERIORITY_OR_OTHER|||||||0.01||95.0|||||ANOVA|||OV: P value was calculated using ANOVA.||||0.010
72557824|NCT00205777|144645448|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANOVA|||OS: P value was calculated using ANOVA.||||0.050
72557825|NCT00205777|144645448|SUPERIORITY_OR_OTHER|||||||0.045||95.0|||||ANOVA|||OS: P value was calculated using ANOVA.||||0.045
72557826|NCT00205777|144645448|SUPERIORITY_OR_OTHER|||||||0.18||95.0|||||ANOVA|||OcS: P value was calculated using ANOVA.||||0.18
72557827|NCT00205777|144645448|SUPERIORITY_OR_OTHER|||||||0.56||95.0|||||ANOVA|||OcS: P value was calculated using ANOVA.||||0.56
72557828|NCT00205777|144645448|SUPERIORITY_OR_OTHER|||||||0.14||95.0|||||ANOVA|||ObS: P value was calculated using ANOVA.||||0.14
72557829|NCT00205777|144645448|SUPERIORITY_OR_OTHER|||||||0.22||95.0|||||ANOVA|||ObS: P value was calculated using ANOVA.||||0.22
72557830|NCT00205777|144645448|SUPERIORITY_OR_OTHER|||||||0.11||95.0|||||ANOVA|||MS: P value was calculated using ANOVA.||||0.11
72557831|NCT00205777|144645448|SUPERIORITY_OR_OTHER|||||||0.055||95.0|||||ANOVA|||MS: P value was calculated using ANOVA.||||0.055
72557832|NCT00205777|144645448|SUPERIORITY_OR_OTHER|||||||0.069||95.0|||||ANOVA|||ES: P value was calculated using ANOVA.||||0.069
72557833|NCT00205777|144645448|SUPERIORITY_OR_OTHER|||||||0.28||95.0|||||ANOVA|||ES: P value was calculated using ANOVA.||||0.28
72557834|NCT00205777|144645448|SUPERIORITY_OR_OTHER|||||||0.62||95.0|||||ANOVA|||OMS: P value was calculated using ANOVA.||||0.62
72557835|NCT00205777|144645448|SUPERIORITY_OR_OTHER|||||||0.96||95.0|||||ANOVA|||OMS: P value was calculated using ANOVA.||||0.96
72557836|NCT00205777|144645449|SUPERIORITY_OR_OTHER|||||||0.22|TWO_SIDED||||||ANOVA|||WTh: P value was calculated using ANOVA.||||0.22
72557837|NCT00205777|144645449|SUPERIORITY_OR_OTHER|||||||0.087|TWO_SIDED||||||ANOVA|||WTh: p-value was calculated using ANOVA.||||0.087
72557838|NCT00205777|144645449|SUPERIORITY_OR_OTHER|||||||0.37|TWO_SIDED||||||ANOVA|||WTh: p-value was calculated using ANOVA.||||0.37
72557839|NCT00205777|144645449|SUPERIORITY_OR_OTHER|||||||0.73|TWO_SIDED||||||ANOVA|||WTh: p-value was calculated using ANOVA.||||0.73
72557840|NCT00205777|144645449|SUPERIORITY_OR_OTHER|||||||0.41|TWO_SIDED||||||ANOVA|||WTh: p-value was calculated using ANOVA.||||0.41
72557841|NCT00205777|144645449|SUPERIORITY_OR_OTHER|||||||0.085||95.0|||||ANOVA|||OTh: P value was calculated using ANOVA.||||0.085
72557842|NCT00205777|144645449|SUPERIORITY_OR_OTHER|||||||0.15||95.0|||||ANOVA|||OTh: P value was calculated using ANOVA.||||0.15
72557843|NCT00205777|144645449|SUPERIORITY_OR_OTHER|||||||0.71||95.0|||||ANOVA|||OTh: P value was calculated using ANOVA.||||0.71
72557844|NCT00205777|144645449|SUPERIORITY_OR_OTHER|||||||0.042||95.0|||||ANOVA|||OTh: P value was calculated using ANOVA.||||0.042
72557845|NCT00205777|144645449|SUPERIORITY_OR_OTHER|||||||0.077||95.0|||||ANOVA|||OTh: P value was calculated using ANOVA.||||0.077
72557846|NCT00205777|144645449|SUPERIORITY_OR_OTHER|||||||0.35||95.0|||||ANOVA|||TbTh: P value was calculated using ANOVA.||||0.35
72557847|NCT00205777|144645449|SUPERIORITY_OR_OTHER|||||||0.12||95.0|||||ANOVA|||TbTh: P value was calculated using ANOVA.||||0.12
72434955|NCT00383188|144383167|SUPERIORITY||LSM Difference|-0.493|STANDARD_ERROR_OF_MEAN|1.038||0.6349|TWO_SIDED|95.0|-2.532|1.545|||ANCOVA|||Week 4: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 4 as an interaction term, baseline swollen joint count as the covariate and participant as a random effect.||1.545|-2.532|0.6349
72494150|NCT03237065|144517214|SUPERIORITY||Mean Difference (Final Values)|-4.64||||0.2997|TWO_SIDED|95.0|-13.47|4.19|||Mixed model for repeated measures|||"Day 7~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||4.19|-13.47|0.2997
72382854|NCT00145600|144274289|SUPERIORITY_OR_OTHER_LEGACY||Spearman Correlation Coefficients|0.41|||<|0.0001||95.0|||||Spearman Correlation Coefficients|||||||<0.0001
72382855|NCT00145600|144274289|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||Wilcoxon signed rank test|||||||<0.0001
72382856|NCT00145600|144274289|SUPERIORITY_OR_OTHER_LEGACY||Spearman Correlation Coefficients|0.42|||<|0.0001||95.0|||||Spearman Correlation Coefficients|||||||<0.0001
72382857|NCT00145600|144274289|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3624||95.0|||||Wilcoxon signed rank test|||||||0.3624
72494151|NCT03237065|144517214|SUPERIORITY||Mean Difference (Final Values)|0.4||||0.9221|TWO_SIDED|95.0|-7.75|8.56|||Mixed model for repeated measures|||"Day 8~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||8.56|-7.75|0.9221
72494152|NCT03237065|144517214|SUPERIORITY||Mean Difference (Final Values)|-15.69||||0.0034|TWO_SIDED|95.0|-26.07|-5.32|||Mixed model for repeated measures|||"Day 14~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||-5.32|-26.07|0.0034
72494153|NCT03237065|144517214|SUPERIORITY||Mean Difference (Final Values)|-22.54||||0.0002|TWO_SIDED|95.0|-33.93|-11.16|||Mixed model for repeated measures|||"Day 21~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||-11.16|-33.93|0.0002
72504737|NCT03114969|144540498|SUPERIORITY||Odds Ratio (OR)|1.223||||0.746|TWO_SIDED|95.0|0.361|4.151||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator.|||4.151|0.361|0.746
72382858|NCT00145600|144274289|SUPERIORITY_OR_OTHER_LEGACY||Spearman Correlation Coefficients|0.52|||<|0.0001||95.0|||||Spearman Correlation Coefficients|||||||<0.0001
72382859|NCT00145600|144274290|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0254||95.0|||||Wilcoxon signed rank test|||||||0.0254
72382860|NCT00145600|144274290|SUPERIORITY_OR_OTHER_LEGACY||Spearman Correlation Coefficients|0.44|||<|0.0001||95.0|||||Spearman Correlation Coefficients|||||||<0.0001
72382861|NCT00145600|144274290|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0004||95.0|||||Wilcoxon signed rank test|||||||0.0004
72382862|NCT00145600|144274290|SUPERIORITY_OR_OTHER_LEGACY||Spearman Correlation Coefficients|0.32||||0.0001||95.0|||||Spearman Correlation Coefficients|||||||0.0001
72382863|NCT00145600|144274290|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||Wilcoxon Correlation Coefficients|||||||<0.0001
72382864|NCT00145600|144274290|SUPERIORITY_OR_OTHER_LEGACY||Spearman Correlation Coefficients|0.39|||<|0.0001||95.0|||||Spearman Correlation Coefficients|||||||<0.0001
72382865|NCT00145600|144274290|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0014||95.0|||||Wilcoxon signed rank test|||||||0.0014
72382866|NCT00145600|144274290|SUPERIORITY_OR_OTHER_LEGACY||Spearman Correlation Coefficients|0.26||||0.0061||95.0|||||Spearman Correlation Coefficients|||||||0.0061
72382867|NCT00145600|144274291|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0687||95.0|||||Wilcoxon signed rank test|||||||0.0687
72434956|NCT00383188|144383167|SUPERIORITY||LSM Difference|-1.176|STANDARD_ERROR_OF_MEAN|0.88||0.1818|TWO_SIDED|95.0|-2.903|0.551|||ANCOVA|||Week 8: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 8 as an interaction term, baseline swollen joint count as the covariate and participant as a random effect.||0.551|-2.903|0.1818
72434957|NCT00383188|144383167|SUPERIORITY||LSM Difference|-1.268|STANDARD_ERROR_OF_MEAN|0.862||0.1421|TWO_SIDED|95.0|-2.961|0.426|||ANCOVA|||Week 8: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 8 as an interaction term, baseline swollen joint count as the covariate and participant as a random effect.||0.426|-2.961|0.1421
72434958|NCT00383188|144383167|SUPERIORITY||LSM Difference|-0.898|STANDARD_ERROR_OF_MEAN|1.006||0.3726|TWO_SIDED|95.0|-2.874|1.078|||ANCOVA|||Week 8: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 8 as an interaction term, baseline swollen joint count as the covariate and participant as a random effect.||1.078|-2.874|0.3726
72434959|NCT00383188|144383167|SUPERIORITY||LSM Difference|-0.701|STANDARD_ERROR_OF_MEAN|1.038||0.4995|TWO_SIDED|95.0|-2.739|1.337|||ANCOVA|||Week 8: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 8 as an interaction term, baseline swollen joint count as the covariate and participant as a random effect.||1.337|-2.739|0.4995
72434960|NCT00383188|144383167|SUPERIORITY||LSM Difference|-1.601|STANDARD_ERROR_OF_MEAN|0.879||0.0691|TWO_SIDED|95.0|-3.327|0.126|||ANCOVA|||Week 12: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 12 as an interaction term, baseline swollen joint count as the covariate and participant as a random effect.||0.126|-3.327|0.0691
72557848|NCT00205777|144645449|SUPERIORITY_OR_OTHER|||||||0.41||95.0|||||ANOVA|||TbTh: P value was calculated using ANOVA.||||0.41
72557849|NCT00205777|144645449|SUPERIORITY_OR_OTHER|||||||0.9||95.0|||||ANOVA|||TbTh: P value was calculated using ANOVA.||||0.90
72557850|NCT00205777|144645449|SUPERIORITY_OR_OTHER|||||||0.46||95.0|||||ANOVA|||TbTh: P value was calculated using ANOVA.||||0.46
72382868|NCT00145600|144274291|SUPERIORITY_OR_OTHER_LEGACY||Spearman Correlation Coefficients|0.65|||<|0.0001||95.0|||||Spearman Correlation Coefficient|||||||<0.0001
72382869|NCT00145600|144274291|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9478||95.0|||||Wilcoxon signed rank test|||||||0.9478
72382870|NCT00145600|144274291|SUPERIORITY_OR_OTHER_LEGACY||Spearman Correlation Coefficients|0.42|||<|0.0001||95.0|||||Spearman Correlation Coefficients|||||||<0.0001
72382871|NCT00145600|144274291|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2999||95.0|||||Wilcoxon signed rank test|||||||0.2999
72382872|NCT00145600|144274291|SUPERIORITY_OR_OTHER_LEGACY||Spearman Correlation Coefficients|0.49|||<|0.0001||95.0|||||Spearman Correlation Coefficients|||||||<0.0001
72382873|NCT00145600|144274291|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3121||95.0|||||Wilcoxon signed rank test|||||||0.3121
72382874|NCT00145600|144274291|SUPERIORITY_OR_OTHER_LEGACY||Spearman Correlation Coefficients|0.52|||<|0.0001||95.0|||||Spearman Correlation Coefficients|||||||<0.0001
72382875|NCT00145600|144274292|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0014||95.0|||||Wilcoxon signed rank test|||||||0.0014
72382876|NCT00145600|144274292|SUPERIORITY_OR_OTHER_LEGACY||Spearman Correlation Coefficients|0.57|||<|0.0001||95.0|||||Spearman Correlation Coefficients|||||||<0.0001
72382877|NCT00145600|144274292|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0282||95.0|||||Wilcoxon signed rank test|||||||0.0282
72382878|NCT00145600|144274292|SUPERIORITY_OR_OTHER_LEGACY||Spearman Correlation Coefficients|0.35||||0.0002||95.0|||||Spearman Correlation Coefficients|||||||0.0002
72382879|NCT00145600|144274292|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0038||95.0|||||Wilcoxon signed rank test|||||||0.0038
72382880|NCT00145600|144274292|SUPERIORITY_OR_OTHER_LEGACY||Spearman Correlation Coefficients|0.43|||<|0.0001||95.0|||||Spearman Correlation Coefficients|||||||<0.0001
72382881|NCT00145600|144274292|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1474||95.0|||||Wilcoxon signed rank test|||||||0.1474
72382882|NCT00145600|144274292|SUPERIORITY_OR_OTHER_LEGACY||Spearman Correlation Coefficients|0.49|||<|0.0001||95.0|||||Spearman Correlation Coefficients|||||||<0.0001
72382883|NCT00145600|144274293|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0281||95.0|||||Wilcoxon signed rank test|||||||0.0281
72382884|NCT00145600|144274293|SUPERIORITY_OR_OTHER_LEGACY||Spearman Correlation Coefficients|0.63|||<|0.0001||95.0|||||Spearman Correlation Coefficients|||||||<0.0001
72382885|NCT00145600|144274293|SUPERIORITY_OR_OTHER_LEGACY|||||||0.005||95.0|||||Wilcoxon signed rank test|||||||0.0050
72382886|NCT00145600|144274293|SUPERIORITY_OR_OTHER_LEGACY||Spearman Correlation Coefficients|0.45|||<|0.0001||95.0|||||Spearman Correlation Coefficients|||||||<0.0001
72382887|NCT00145600|144274293|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0005||95.0|||||Wilcoxon signed rank test|||||||0.0005
72382888|NCT00145600|144274293|SUPERIORITY_OR_OTHER_LEGACY||Spearman Correlation Coefficients|0.37||||0.0001||95.0|||||Spearman Correlation Coefficients|||||||0.0001
72382889|NCT00145600|144274293|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0552||95.0|||||Wilcoxon signed rank test|||||||0.0552
72382890|NCT00145600|144274293|SUPERIORITY_OR_OTHER_LEGACY||Spearman Correlation Coefficients|0.54|||<|0.0001||95.0|||||Spearman Correlation Coefficients|||||||<0.0001
72382891|NCT00145600|144274294|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||Wilcoxon signed rank test|||||||<0.0001
72382892|NCT00145600|144274294|SUPERIORITY_OR_OTHER_LEGACY||Spearman Correlation Coefficients|0.53|||<|0.0001||95.0|||||Spearman Correlation Coefficients|||||||<0.0001
72382893|NCT00145600|144274294|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||Wilcoxan signed rank test|||||||<0.0001
72382894|NCT00145600|144274294|SUPERIORITY_OR_OTHER_LEGACY||Spearman Correlation Coefficients|0.68|||<|0.0001||95.0|||||Spearman Correlation Coefficients|||||||<0.0001
72382895|NCT00145600|144274294|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0017||95.0|||||Wilcoxon signed rank test|||||||0.0017
72382896|NCT00145600|144274294|SUPERIORITY_OR_OTHER_LEGACY||Spearman Correlation Coefficients|0.5|||<|0.0001||95.0|||||Spearman Correlation Coefficients|||||||<0.0001
72382897|NCT00145600|144274295|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2758||95.0|||||Wilcoxon signed rank test|||||||0.2758
72382898|NCT00145600|144274295|SUPERIORITY_OR_OTHER_LEGACY||Spearman Correlation Coefficients|0.6|||<|0.0001||95.0|||||Spearman Correlation Coefficients|||||||<0.0001
72382899|NCT00145600|144274295|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1731||95.0|||||Wilcoxon signed rank test|||||||0.1731
72382900|NCT00145600|144274295|SUPERIORITY_OR_OTHER_LEGACY||Spearman Correlation Coefficients|0.6|||<|0.0001||95.0|||||Spearman Correlation Coefficients|||||||<0.0001
72382901|NCT00145600|144274295|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0846||95.0|||||Wilcoxon signed rank test|||||||0.0846
72382902|NCT00145600|144274295|SUPERIORITY_OR_OTHER_LEGACY||Spearman Correlation Coefficients|0.46|||<|0.0001||95.0|||||Spearman Correlation Coefficients|||||||<0.0001
72382903|NCT00145600|144274296|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4263||95.0|||||Wilcoxon signed rank test|||||||0.4263
72382904|NCT00145600|144274296|SUPERIORITY_OR_OTHER_LEGACY||Spearman Correlation Coefficients|0.51|||<|0.0001||95.0|||||Spearman Correlation Coefficients|||||||<0.0001
72382905|NCT00145600|144274296|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||Wilcoxon signed rank test|||||||<0.0001
72382906|NCT00145600|144274296|SUPERIORITY_OR_OTHER_LEGACY||Spearman Correlation Coefficients|0.54|||<|0.0001||95.0|||||Spearman Correlation Coefficients|||||||<0.0001
72557851|NCT00205777|144645449|SUPERIORITY_OR_OTHER|||||||0.18||95.0|||||ANOVA|||TbSp: P value was calculated using ANOVA.||||0.18
72557852|NCT00205777|144645449|SUPERIORITY_OR_OTHER|||||||0.75||95.0|||||ANOVA|||TbSp: P value was calculated using ANOVA.||||0.75
72557853|NCT00205777|144645449|SUPERIORITY_OR_OTHER|||||||0.1||95.0|||||ANOVA|||TbSp: P value was calculated using ANOVA.||||0.10
72557854|NCT00205777|144645449|SUPERIORITY_OR_OTHER|||||||0.79||95.0|||||ANOVA|||TbSp: P value was calculated using ANOVA.||||0.79
72557855|NCT00205777|144645449|SUPERIORITY_OR_OTHER|||||||0.057||95.0|||||ANOVA|||TbSp: P value was calculated using ANOVA.||||0.057
72557856|NCT00205777|144645449|SUPERIORITY_OR_OTHER|||||||0.17||95.0|||||ANOVA|||CTh: P value was calculated using ANOVA.||||0.17
72557857|NCT00205777|144645449|SUPERIORITY_OR_OTHER|||||||0.46||95.0|||||ANOVA|||CTh: P value was calculated using ANOVA.||||0.46
72557858|NCT00205777|144645449|SUPERIORITY_OR_OTHER|||||||0.83||95.0|||||ANOVA|||CTh: P value was calculated using ANOVA.||||0.83
72557859|NCT00205777|144645449|SUPERIORITY_OR_OTHER|||||||0.25||95.0|||||ANOVA|||CTh: P value was calculated using ANOVA.||||0.25
72557860|NCT00205777|144645449|SUPERIORITY_OR_OTHER|||||||0.35||95.0|||||ANOVA|||CTh: P value was calculated using ANOVA.||||0.35
72557861|NCT00205777|144645450|SUPERIORITY_OR_OTHER|||||||0.018|TWO_SIDED||||||ANOVA|||WTh: P value was calculated using ANOVA.||||0.018
72557862|NCT00205777|144645450|SUPERIORITY_OR_OTHER|||||||0.29|TWO_SIDED||||||ANOVA|||WTh: P value was calculated using ANOVA.||||0.29
72557863|NCT00205777|144645450|SUPERIORITY_OR_OTHER|||||||0.049||95.0|||||ANOVA|||OTh: P value was calculated using ANOVA.||||0.049
72557864|NCT00205777|144645450|SUPERIORITY_OR_OTHER|||||||0.37||95.0|||||ANOVA|||OTh: P value was calculated using ANOVA.||||0.37
72557865|NCT00205777|144645450|SUPERIORITY_OR_OTHER|||||||0.97||95.0|||||ANOVA|||TbTh: P value was calculated using ANOVA.||||0.97
72557866|NCT00205777|144645450|SUPERIORITY_OR_OTHER|||||||0.78||95.0|||||ANOVA|||TbTh: P value was calculated using ANOVA.||||0.78
72382907|NCT00145600|144274296|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0468||95.0|||||Wilcoxon signed rank test|||||||0.0468
72382908|NCT00145600|144274296|SUPERIORITY_OR_OTHER_LEGACY||Spearman Correlation Coefficients|0.55|||<|0.0001||95.0|||||Spearman Correlation Coefficients|||||||<0.0001
72382909|NCT00145600|144274297|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||Wilcoxon signed rank test|||||||<0.0001
72382910|NCT00145600|144274297|SUPERIORITY_OR_OTHER_LEGACY||Spearman Correlation Coefficients|0.26||||0.0019||95.0|||||Spearman Correlation Coefficients|||||||0.0019
72382911|NCT00145600|144274297|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||Wilcoxon signed rank test|||||||<0.0001
72382912|NCT00145600|144274297|SUPERIORITY_OR_OTHER_LEGACY||Spearman Correlation Coefficients|0.16||||0.0704||95.0|||||Spearman Correlation Coefficients|||||||0.0704
72382913|NCT00145600|144274297|SUPERIORITY_OR_OTHER_LEGACY|||||||0.02||95.0|||||Wilcoxon signed rank test|||||||0.0200
72382914|NCT00145600|144274297|SUPERIORITY_OR_OTHER_LEGACY||Spearman Correlation Coefficients|0.42|||<|0.0001||95.0|||||Spearman Correlation Coefficients|||||||<0.0001
72382915|NCT00145600|144274298|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7192||95.0|||||Wilcoxon signed rank test|||||||0.7192
72382916|NCT00145600|144274298|SUPERIORITY_OR_OTHER_LEGACY||Spearman Correlation Coefficients|0.42|||<|0.0001||95.0|||||Spearman Correlation Coefficients|||||||<0.0001
72382917|NCT00145600|144274298|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8663||95.0|||||Wilcoxon signed rank test|||||||0.8663
72382918|NCT00145600|144274298|SUPERIORITY_OR_OTHER_LEGACY||Spearman Correlation Coefficients|0.41|||<|0.0001||95.0|||||Spearman Correlation Coefficients|||||||<0.0001
72382919|NCT00145600|144274298|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7626||95.0|||||Wilcoxon signed rank test|||||||0.7626
72382920|NCT00145600|144274298|SUPERIORITY_OR_OTHER_LEGACY||Spearman Correlation Coefficients|0.58|||<|0.0001||95.0|||||Spearman Correlation Coefficients|||||||<0.0001
72382921|NCT00145600|144274299|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4807||95.0|||||Wilcoxon signed rank test|||||||0.4807
72382922|NCT00145600|144274299|SUPERIORITY_OR_OTHER_LEGACY||Spearman Correlation Coefficients|0.36|||<|0.0001||95.0|||||Spearman Correlation Coefficients|||||||<0.0001
72382923|NCT00145600|144274299|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0824||95.0|||||Wilcoxon signed rank test|||||||0.0824
72382924|NCT00145600|144274299|SUPERIORITY_OR_OTHER_LEGACY||Spearman Correlation Coefficients|0.39|||<|0.0001||95.0|||||Spearman Correlation Coefficients|||||||<0.0001
72382925|NCT00145600|144274299|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0496||95.0|||||Wilcoxon signed rank test|||||||0.0496
72382926|NCT00145600|144274299|SUPERIORITY_OR_OTHER_LEGACY||Spearman Correlation Coefficients|0.5|||<|0.0001||95.0|||||Spearman Correlation Coefficients|||||||<0.0001
72382927|NCT00145600|144274300|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0157||95.0|||||Wilcoxon signed rank test|||||||0.0157
72382928|NCT00145600|144274300|SUPERIORITY_OR_OTHER_LEGACY||Spearman Correlation Coefficients|0.37|||<|0.0001||95.0|||||Spearman Correlation Coefficients|||||||<0.0001
72382929|NCT00145600|144274300|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0014||95.0|||||Wilcoxon signed rank test|||||||0.0014
72557867|NCT00205777|144645450|SUPERIORITY_OR_OTHER|||||||0.43||95.0|||||ANOVA|||TbSp: P value was calculated using ANOVA.||||0.43
72557868|NCT00205777|144645450|SUPERIORITY_OR_OTHER|||||||0.32||95.0|||||ANOVA|||TbSp: P value was calculated using ANOVA.||||0.32
72557869|NCT00205777|144645451|SUPERIORITY_OR_OTHER|||||||0.35|TWO_SIDED||||||ANOVA|||||||0.35
72557870|NCT00205777|144645451|SUPERIORITY_OR_OTHER|||||||0.66||95.0|||||ANOVA|||||||0.66
72557871|NCT00205777|144645451|SUPERIORITY_OR_OTHER|||||||0.3||95.0|||||ANOVA|||||||0.30
72557872|NCT00205777|144645451|SUPERIORITY_OR_OTHER|||||||0.95||95.0|||||ANOVA|||||||0.95
72557873|NCT00205777|144645451|SUPERIORITY_OR_OTHER|||||||0.15||95.0|||||ANOVA|||||||0.15
72557874|NCT00205777|144645452|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||ANOVA|||||||1.00
72557875|NCT00205777|144645452|SUPERIORITY_OR_OTHER|||||||0.4||95.0|||||ANOVA|||||||0.40
72557876|NCT00205777|144645453|SUPERIORITY_OR_OTHER|||||||0.71|TWO_SIDED||||||ANOVA|||||||0.71
72557877|NCT00205777|144645453|SUPERIORITY_OR_OTHER|||||||0.83||95.0|||||ANOVA|||||||0.83
72557878|NCT00205777|144645453|SUPERIORITY_OR_OTHER|||||||0.63||95.0|||||ANOVA|||||||0.63
72557879|NCT00205777|144645453|SUPERIORITY_OR_OTHER|||||||0.92||95.0|||||ANOVA|||||||0.92
72557880|NCT00205777|144645453|SUPERIORITY_OR_OTHER|||||||0.5||95.0|||||ANOVA|||||||0.50
72557881|NCT00205777|144645454|SUPERIORITY_OR_OTHER|||||||0.73|TWO_SIDED||||||ANOVA|||||||0.73
72557882|NCT00205777|144645454|SUPERIORITY_OR_OTHER|||||||0.8||95.0|||||ANOVA|||||||0.80
72557883|NCT00205777|144645455|SUPERIORITY_OR_OTHER|||||||0.81|TWO_SIDED||||||ANOVA|||BFP: P value was calculated using ANOVA.||||0.81
72557884|NCT00205777|144645455|SUPERIORITY_OR_OTHER|||||||0.96|TWO_SIDED||||||ANOVA|||BFP: P value was calculated using ANOVA.||||0.96
72557885|NCT00205777|144645455|SUPERIORITY_OR_OTHER|||||||0.005|TWO_SIDED||||||ANOVA|||BFP: P value was calculated using ANOVA.||||0.005
72557886|NCT00205777|144645455|SUPERIORITY_OR_OTHER|||||||0.013|TWO_SIDED||||||ANOVA|||BFP: P value was calculated using ANOVA.||||0.013
72557887|NCT00205777|144645455|SUPERIORITY_OR_OTHER|||||||0.006|TWO_SIDED||||||ANOVA|||BFP: P value was calculated using ANOVA.||||0.006
72557888|NCT00205777|144645455|SUPERIORITY_OR_OTHER|||||||0.7||95.0|||||ANOVA|||RP: P value was calculated using ANOVA.||||0.70
72557889|NCT00205777|144645455|SUPERIORITY_OR_OTHER|||||||0.44||95.0|||||ANOVA|||RP: P value was calculated using ANOVA.||||0.44
72434961|NCT00383188|144383167|SUPERIORITY||LSM Difference|-1.086|STANDARD_ERROR_OF_MEAN|0.862||0.2083|TWO_SIDED|95.0|-2.778|0.607|||ANCOVA|||Week 12: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 12 as an interaction term, baseline swollen joint count as the covariate and participant as a random effect.||0.607|-2.778|0.2083
72557890|NCT00205777|144645455|SUPERIORITY_OR_OTHER|||||||0.47||95.0|||||ANOVA|||RP: P value was calculated using ANOVA.||||0.47
72618716|NCT01026038|144768108|SUPERIORITY_OR_OTHER||GMT ratio|1.0|||||TWO_SIDED|95.0|0.28|3.23||||||Serotype 19A: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||3.23|0.28|
72382930|NCT00145600|144274300|SUPERIORITY_OR_OTHER_LEGACY||Spearman Correlation Coefficients|0.43|||<|0.0001||95.0|||||Spearman Correlation Coefficients|||||||<0.0001
72382931|NCT00145600|144274300|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1478||95.0|||||Wilcoxon signed rank test|||||||0.1478
72382932|NCT00145600|144274300|SUPERIORITY_OR_OTHER_LEGACY||Spearman Correlation Coefficients|0.56|||<|0.0001||95.0|||||Spearman Correlation Coefficients|||||||<0.0001
72382933|NCT00145600|144274301|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0831||95.0|||||Wilcoxon signed rank test|||||||0.0831
72382934|NCT00145600|144274301|SUPERIORITY_OR_OTHER_LEGACY||Spearman Correlation Coefficients|0.25||||0.0027||95.0|||||Spearman Correlation Coefficients|||||||0.0027
72382935|NCT00145600|144274301|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0135||95.0|||||Wilcoxon signed rank test|||||||0.0135
72382936|NCT00145600|144274301|SUPERIORITY_OR_OTHER_LEGACY||Spearman Correlation Coefficients|0.27||||0.0024||95.0|||||Spearman Correlation Coefficients|||||||0.0024
72382937|NCT00145600|144274301|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9848||95.0|||||Wilcoxon signed rank test|||||||0.9848
72382938|NCT00145600|144274301|SUPERIORITY_OR_OTHER_LEGACY||Spearman Correlation Coefficients|0.16||||0.0974||95.0|||||Spearman Correlation Coefficients|||||||0.0974
72382939|NCT00145600|144274302|SUPERIORITY_OR_OTHER_LEGACY|||||||0.004||95.0|||||Wilcoxon signed rank test|||||||0.0040
72382940|NCT00145600|144274302|SUPERIORITY_OR_OTHER_LEGACY||Spearman Correlation Coefficients|0.43|||<|0.0001||95.0|||||Spearman Correlation Coefficients|||||||<0.0001
72382941|NCT00145600|144274302|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0012||95.0|||||Wilcoxon signed rank test|||||||0.0012
72382942|NCT00145600|144274302|SUPERIORITY_OR_OTHER_LEGACY||Spearman Correlation Coefficients|0.54|||<|0.0001||95.0|||||Spearman Correlation Coefficients|||||||<0.0001
72382943|NCT00145600|144274302|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8108||95.0|||||Wilcoxon signed rank test|||||||0.8108
72382944|NCT00145600|144274302|SUPERIORITY_OR_OTHER_LEGACY||Spearman Correlation Coefficients|0.55|||<|0.0001||95.0|||||Spearman Correlation Coefficients|||||||<0.0001
72382945|NCT00145600|144274303|SUPERIORITY_OR_OTHER_LEGACY||KM Event-free survival estimate|0.874|||||TWO_SIDED|95.0|0.805|0.944||||||||0.944|0.805|
72382946|NCT00145600|144274303|SUPERIORITY_OR_OTHER_LEGACY||KM event-free survival estimate|0.844|||||TWO_SIDED|95.0|0.739|0.95||||||||0.950|0.739|
72382947|NCT00145600|144274303|SUPERIORITY_OR_OTHER_LEGACY||KM event-free survival estimate|0.667|||||TWO_SIDED|95.0|0.4|0.933||||||||0.933|0.400|
72382948|NCT00145600|144274303|SUPERIORITY_OR_OTHER_LEGACY||KM event-free survival estimate|0.785|||||TWO_SIDED|95.0|0.716|0.853||||||||0.853|0.716|
72382949|NCT02600351|144274312|NON_INFERIORITY|With a 10% non-inferiority margin, a sample size of 90 participants per treatment group was required to provide at least 90% power to establish non-inferiority at the 1-sided 0.025 level, assuming the SVR12 rates were 98% for both groups.|Difference in percentages|-18.8||||0.065|TWO_SIDED|95.0|-40.7|3.2|||Cochran-Mantel-Haenszel|||||3.2|-40.7|0.065
72382950|NCT02600351|144274312|NON_INFERIORITY|With a 10% non-inferiority margin, a sample size of 125 participants per treatment group was required to provide at least 90% power to establish non-inferiority at the 1-sided 0.025 level, assuming the SVR12 rates were 95% for both groups.|Difference in percentages|-11.7||||0.25|TWO_SIDED|95.0|-32.1|8.8|||Cochran-Mantel-Haenszel|||||8.8|-32.1|0.25
72382951|NCT02556203|144274326|NON_INFERIORITY|1-sided Confidence interval|Hazard Ratio (HR)|1.2089302|||||ONE_SIDED|97.5||1.7040824||||||"H0: HR(t)\>=1.20 for all time points t\>=0, (i.e. the hazard for the primary efficacy endpoint in the rivaroxaban-based treatment group is more than 20% larger than that in the antiplatelet-based control group)"||1.7040824||
72382952|NCT02556203|144274327|SUPERIORITY|2-sided Log Rank test|Hazard Ratio (HR)|1.35|||=|0.04223|TWO_SIDED|95.0|1.01|1.81|||Log Rank|||||1.81|1.01|= 0.04223
72382953|NCT02556203|144274328|OTHER|Descriptive. 2-sided Log Rank test.|Hazard Ratio (HR)|1.5|||=|0.07745|TWO_SIDED|95.0|0.95|2.37|||Log Rank||Estimates for HRs are based on Cox proportional hazards model. HRs \>1 indicate a higher hazard rate in the rivaroxaban arm compared with the antiplatelet arm.|||2.37|0.95|= 0.07745
72382954|NCT02556203|144274329|SUPERIORITY|2-sided Log Rank test|Hazard Ratio (HR)|1.39|||=|0.01156|TWO_SIDED|95.0|1.08|1.8|||Log Rank||Estimates for HRs are based on Cox proportional hazards model. HRs \>1 indicate a higher hazard rate in the rivaroxaban arm compared with the antiplatelet arm.|||1.80|1.08|= 0.01156
72382955|NCT02556203|144274330|SUPERIORITY|2-sided Log Rank test|Hazard Ratio (HR)|1.22|||=|0.21595|TWO_SIDED|95.0|0.89|1.69|||Log Rank||Estimates for HRs are based on Cox proportional hazards model. HRs \>1 indicate a higher hazard rate in the rivaroxaban arm compared with the antiplatelet arm.|||1.69|0.89|= 0.21595
72382956|NCT02556203|144274331|OTHER|Descriptive. 2-sided Log Rank test.|Hazard Ratio (HR)|1.78|||=|0.02216|TWO_SIDED|95.0|1.08|2.94|||Log Rank||Estimates for HRs are based on Cox proportional hazards model. HRs \>1 indicate a higher hazard rate in the rivaroxaban arm compared with the antiplatelet arm.|||2.94|1.08|= 0.02216
72382957|NCT02556203|144274332|OTHER|Descriptive. 2-sided Log Rank test.|Hazard Ratio (HR)|1.66|||=|0.02702|TWO_SIDED|95.0|1.05|2.62|||Log Rank||Estimates for HRs are based on Cox proportional hazards model. HRs \>1 indicate a higher hazard rate in the rivaroxaban arm compared with the antiplatelet arm.|||2.62|1.05|= 0.02702
72557891|NCT00205777|144645455|SUPERIORITY_OR_OTHER|||||||0.28||95.0|||||ANOVA|||RP: P value was calculated using ANOVA.||||0.28
72557892|NCT00205777|144645455|SUPERIORITY_OR_OTHER|||||||0.14||95.0|||||ANOVA|||RP: P value was calculated using ANOVA.||||0.14
72557893|NCT00205777|144645455|SUPERIORITY_OR_OTHER|||||||0.93||95.0|||||ANOVA|||RmP: P value was calculated using ANOVA.||||0.93
72557894|NCT00205777|144645455|SUPERIORITY_OR_OTHER|||||||0.85||95.0|||||ANOVA|||RmP: P value was calculated using ANOVA.||||0.85
72434962|NCT00383188|144383167|SUPERIORITY||LSM Difference|-0.836|STANDARD_ERROR_OF_MEAN|1.006||0.4063|TWO_SIDED|95.0|-2.811|1.139|||ANCOVA|||Week 12: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 12 as an interaction term, baseline swollen joint count as the covariate and participant as a random effect.||1.139|-2.811|0.4063
72434963|NCT00383188|144383167|SUPERIORITY||LSM Difference|-0.196|STANDARD_ERROR_OF_MEAN|1.038||0.8501|TWO_SIDED|95.0|-2.234|1.841|||ANCOVA|||Week 12: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 12 as an interaction term, baseline swollen joint count as the covariate and participant as a random effect.||1.841|-2.234|0.8501
72434964|NCT00383188|144383167|SUPERIORITY||LSM Difference|0.376|STANDARD_ERROR_OF_MEAN|0.904||0.6778|TWO_SIDED|95.0|-1.399|2.15|||ANCOVA|||Week 16: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 16 as an interaction term, baseline swollen joint count as the covariate and participant as a random effect.||2.150|-1.399|0.6778
72434965|NCT00383188|144383167|SUPERIORITY||LSM Difference|0.508|STANDARD_ERROR_OF_MEAN|0.877||0.5627|TWO_SIDED|95.0|-1.214|2.23|||ANCOVA|||Week 16: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 16 as an interaction term, baseline swollen joint count as the covariate and participant as a random effect.||2.230|-1.214|0.5627
72434966|NCT00383188|144383167|SUPERIORITY||LSM Difference|0.537|STANDARD_ERROR_OF_MEAN|1.038||0.6049|TWO_SIDED|95.0|-1.501|2.576|||ANCOVA|||Week 16: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 16 as an interaction term, baseline swollen joint count as the covariate and participant as a random effect.||2.576|-1.501|0.6049
72434967|NCT00383188|144383167|SUPERIORITY||LSM Difference|0.51|STANDARD_ERROR_OF_MEAN|1.068||0.6332|TWO_SIDED|95.0|-1.587|2.608|||ANCOVA|||Week 16: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 16 as an interaction term, baseline swollen joint count as the covariate and participant as a random effect.||2.608|-1.587|0.6332
72494154|NCT03237065|144517214|SUPERIORITY||Mean Difference (Final Values)|-24.81|||<|0.0001|TWO_SIDED|95.0|-35.42|-14.21|||Mixed model for repeated measures|||"Day 35~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||-14.21|-35.42|<0.0001
72494155|NCT03237065|144517215|SUPERIORITY||Mean Difference (Final Values)|-0.03||||0.3048|TWO_SIDED|95.0|-0.1|0.03|||Mixed model for repeated measures|||"Day 1~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||0.03|-0.10|0.3048
72557895|NCT00205777|144645455|SUPERIORITY_OR_OTHER|||||||0.01||95.0|||||ANOVA|||RmP: P value was calculated using ANOVA.||||0.010
72494156|NCT03237065|144517215|SUPERIORITY||Mean Difference (Final Values)|0.05||||0.1641|TWO_SIDED|95.0|-0.02|0.13|||Mixed model for repeated measures|||"Day 7~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||0.13|-0.02|0.1641
72494157|NCT03237065|144517215|SUPERIORITY||Mean Difference (Final Values)|0.05||||0.1333|TWO_SIDED|95.0|-0.02|0.12|||Mixed model for repeated measures|||"Day 8~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||0.12|-0.02|0.1333
72434968|NCT00383188|144383168|SUPERIORITY||LSM Difference|-2.802|STANDARD_ERROR_OF_MEAN|4.098||0.4943|TWO_SIDED|95.0|-10.85|5.243|||ANCOVA|||Week 1: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 1 as an interaction term, baseline Patient's Assessment of Arthritis Pain (VAS) count as the covariate and participant as a random effect.||5.243|-10.85|0.4943
72434969|NCT00383188|144383168|SUPERIORITY||LSM Difference|-10.19|STANDARD_ERROR_OF_MEAN|4.026||0.0116|TWO_SIDED|95.0|-18.09|-2.283|||ANCOVA|||Week 1: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 1 as an interaction term, baseline Patient's Assessment of Arthritis Pain (VAS) count as the covariate and participant as a random effect.||-2.283|-18.09|0.0116
72434970|NCT00383188|144383168|SUPERIORITY||LSM Difference|-12.73|STANDARD_ERROR_OF_MEAN|4.71||0.007|TWO_SIDED|95.0|-21.98|-3.485|||ANCOVA|||Week 1: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 1 as an interaction term, baseline Patient's Assessment of Arthritis Pain (VAS) count as the covariate and participant as a random effect.||-3.485|-21.98|0.0070
72434971|NCT00383188|144383168|SUPERIORITY||LSM Difference|-11.14|STANDARD_ERROR_OF_MEAN|4.812||0.0209|TWO_SIDED|95.0|-20.58|-1.688|||ANCOVA|||Week 1: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 1 as an interaction term, baseline Patient's Assessment of Arthritis Pain (VAS) count as the covariate and participant as a random effect.||-1.688|-20.58|0.0209
72557896|NCT00205777|144645455|SUPERIORITY_OR_OTHER|||||||0.015||95.0|||||ANOVA|||RmP: P value was calculated using ANOVA.||||0.015
72557897|NCT00205777|144645455|SUPERIORITY_OR_OTHER|||||||0.006||95.0|||||ANOVA|||RmP: P value was calculated using ANOVA.||||0.006
72557898|NCT00205777|144645456|SUPERIORITY_OR_OTHER|||||||0.6|TWO_SIDED||||||ANOVA|||BFP: P value was calculated using ANOVA.||||0.60
72557899|NCT00205777|144645456|SUPERIORITY_OR_OTHER|||||||0.53|TWO_SIDED||||||ANOVA|||BFP: P value was calculated using ANOVA.||||0.53
72557900|NCT00205777|144645456|SUPERIORITY_OR_OTHER|||||||1||95.0|||||ANOVA|||RP: P value was calculated using ANOVA.||||1.00
72434972|NCT00383188|144383168|SUPERIORITY||LSM Difference|-7.439|STANDARD_ERROR_OF_MEAN|4.056||0.0671|TWO_SIDED|95.0|-15.4|0.524|||ANCOVA|||Week 2:Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 2 as an interaction term, baseline Patient's Assessment of Arthritis Pain (VAS) count as the covariate and participant as a random effect.||0.524|-15.40|0.0671
72434973|NCT00383188|144383168|SUPERIORITY||LSM Difference|-10.46|STANDARD_ERROR_OF_MEAN|3.986||0.0089|TWO_SIDED|95.0|-18.28|-2.632|||ANCOVA|||Week 2:Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 2 as an interaction term, baseline Patient's Assessment of Arthritis Pain (VAS) count as the covariate and participant as a random effect.||-2.632|-18.28|0.0089
72434974|NCT00383188|144383168|SUPERIORITY||LSM Difference|-14.1|STANDARD_ERROR_OF_MEAN|4.657||0.0025|TWO_SIDED|95.0|-23.24|-4.959|||ANCOVA|||Week 2:Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 2 as an interaction term, baseline Patient's Assessment of Arthritis Pain (VAS) count as the covariate and participant as a random effect.||-4.959|-23.24|0.0025
72434975|NCT00383188|144383168|SUPERIORITY||LSM Difference|-7.876|STANDARD_ERROR_OF_MEAN|4.774||0.0994|TWO_SIDED|95.0|-17.25|1.496|||ANCOVA|||Week 2:Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 2 as an interaction term, baseline Patient's Assessment of Arthritis Pain (VAS) count as the covariate and participant as a random effect.||1.496|-17.25|0.0994
72434976|NCT00383188|144383168|SUPERIORITY||LSM Difference|-1.964|STANDARD_ERROR_OF_MEAN|4.056||0.6284|TWO_SIDED|95.0|-9.926|5.999|||ANCOVA|||Week 4: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 4 as an interaction term, baseline Patient's Assessment of Arthritis Pain (VAS) count as the covariate and participant as a random effect.||5.999|-9.926|0.6284
72434977|NCT00383188|144383168|SUPERIORITY||LSM Difference|-9.934|STANDARD_ERROR_OF_MEAN|3.986||0.0129|TWO_SIDED|95.0|-17.76|-2.109|||ANCOVA|||Week 4: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 4 as an interaction term, baseline Patient's Assessment of Arthritis Pain (VAS) count as the covariate and participant as a random effect.||-2.109|-17.76|0.0129
72494158|NCT03237065|144517215|SUPERIORITY||Mean Difference (Final Values)|-0.01||||0.9385|TWO_SIDED|95.0|-0.17|0.16|||Mixed model for repeated measures|||"Day 14~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||0.16|-0.17|0.9385
72434978|NCT00383188|144383168|SUPERIORITY||LSM Difference|-8.097|STANDARD_ERROR_OF_MEAN|4.656||0.0825|TWO_SIDED|95.0|-17.24|1.044|||ANCOVA|||Week 4: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 4 as an interaction term, baseline Patient's Assessment of Arthritis Pain (VAS) count as the covariate and participant as a random effect.||1.044|-17.24|0.0825
72434979|NCT00383188|144383168|SUPERIORITY||LSM Difference|-1.907|STANDARD_ERROR_OF_MEAN|4.774||0.6897|TWO_SIDED|95.0|-11.28|7.465|||ANCOVA|||Week 4: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 4 as an interaction term, baseline Patient's Assessment of Arthritis Pain (VAS) count as the covariate and participant as a random effect.||7.465|-11.28|0.6897
72434980|NCT00383188|144383168|SUPERIORITY||LSM Difference|1.861|STANDARD_ERROR_OF_MEAN|4.055||0.6465|TWO_SIDED|95.0|-6.1|9.821|||ANCOVA|||Week 8: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 8 as an interaction term, baseline Patient's Assessment of Arthritis Pain (VAS) count as the covariate and participant as a random effect.||9.821|-6.100|0.6465
72434981|NCT00383188|144383168|SUPERIORITY||LSM Difference|-10.65|STANDARD_ERROR_OF_MEAN|3.985||0.0077|TWO_SIDED|95.0|-18.47|-2.824|||ANCOVA|||Week 8: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 8 as an interaction term, baseline Patient's Assessment of Arthritis Pain (VAS) count as the covariate and participant as a random effect.||-2.824|-18.47|0.0077
72434982|NCT00383188|144383168|SUPERIORITY||LSM Difference|-7.927|STANDARD_ERROR_OF_MEAN|4.655||0.089|TWO_SIDED|95.0|-17.07|1.213|||ANCOVA|||Week 8: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 8 as an interaction term, baseline Patient's Assessment of Arthritis Pain (VAS) count as the covariate and participant as a random effect.||1.213|-17.07|0.0890
72434983|NCT00383188|144383168|SUPERIORITY||LSM Difference|-5.964|STANDARD_ERROR_OF_MEAN|4.773||0.2119|TWO_SIDED|95.0|-15.33|3.406|||ANCOVA|||Week 8: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 8 as an interaction term, baseline Patient's Assessment of Arthritis Pain (VAS) count as the covariate and participant as a random effect.||3.406|-15.33|0.2119
72434984|NCT00383188|144383168|SUPERIORITY||LSM Difference|-4.766|STANDARD_ERROR_OF_MEAN|4.053||0.2401|TWO_SIDED|95.0|-12.72|3.191|||ANCOVA|||Week 12: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 12 as an interaction term, baseline Patient's Assessment of Arthritis Pain (VAS) count as the covariate and participant as a random effect.||3.191|-12.72|0.2401
72494159|NCT03237065|144517215|SUPERIORITY||Mean Difference (Final Values)|0.07||||0.0408|TWO_SIDED|95.0|0.0|0.14|||Mixed model for repeated measures|||"Day 21~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||0.14|0.00|0.0408
72504738|NCT03114969|144540498|SUPERIORITY||Odds Ratio (OR)|5.562||||0.001|TWO_SIDED|95.0|1.932|16.013||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator.|||16.013|1.932|0.001
72557901|NCT00205777|144645456|SUPERIORITY_OR_OTHER|||||||0.43||95.0|||||ANOVA|||RP: P value was calculated using ANOVA.||||0.43
72557902|NCT00205777|144645456|SUPERIORITY_OR_OTHER|||||||0.6||95.0|||||ANOVA|||RmP: P value was calculated using ANOVA.||||0.60
72557903|NCT00205777|144645456|SUPERIORITY_OR_OTHER|||||||0.52||95.0|||||ANOVA|||RmP: P value was calculated using ANOVA.||||0.52
72557904|NCT00205777|144645457|SUPERIORITY_OR_OTHER|||||||0.22|TWO_SIDED||||||ANOVA|||||||0.22
72382958|NCT02556203|144274333|OTHER|Descriptive. 2-sided Log Rank test.|Hazard Ratio (HR)|1.84|||=|1e-05|TWO_SIDED|95.0|1.41|2.41|||Log Rank||Estimates for HRs are based on Cox proportional hazards model. HRs \>1 indicate a higher hazard rate in the rivaroxaban arm compared with the antiplatelet arm.|||2.41|1.41|= 0.00001
72382959|NCT03875768|144274334|SUPERIORITY||Mean Difference (Net)|0.03|STANDARD_DEVIATION|1.72||0.89|TWO_SIDED|95.0|-0.44|0.5||The threshold for statistical significance was p = 0.05.|t-test, 2 sided|Results presented are unadjusted.||The expected effect size is 0.5. The investigators hypothesize that the intervention will lead to an increase in average DASH score of 2 units. The investigators used a standard deviation for 2 units for both intervention and attention control groups since higher variability may be observed with a bigger sample size than the pilot study.||0.50|-0.44|0.89
72382960|NCT03875768|144274335|SUPERIORITY||Mean Difference (Net)|-1.9|STANDARD_DEVIATION|13.0||0.26|TWO_SIDED|95.0|-5.3|1.4||The threshold for statistical significance was p = 0.05.|t-test, 2 sided|Results presented are unadjusted.||The expected effect size for change in systolic blood pressure (SBP) between intervention and control group is 0.6 based on the pilot study. With a 90% power and a type I error rate (alpha) of .01, the investigators can detect the expected effect size with the proposed sample size of 121 per study arm.||1.4|-5.3|0.26
72382961|NCT03875768|144274336|SUPERIORITY||Mean Difference (Net)|-0.9|STANDARD_DEVIATION|8.3||0.39|TWO_SIDED|95.0|-3.1|1.2||The threshold for statistical significance was p = 0.05.|t-test, 2 sided|Results presented are unadjusted.||The expected effect size for change in diastolic blood pressure (DBP) between intervention and control group is 0.75 based on the pilot study. With a 90% power and a type I error rate (alpha) of .01, the investigators can detect the expected effect size with the proposed sample size of 121 per study arm.||1.2|-3.1|0.39
72382962|NCT00580970|144274337|SUPERIORITY_OR_OTHER|||||||0.9138||||||Considering all late rectal toxicities, 38% (20/53) of participants developed physician reported Grade 2 or higher GI toxicity during 2 year follow up. The threshold for significance was p \< 0.05.|t-test, 1 sided|A one sided t-test, with 5% level of significance, and 83% power was used which required 53 subjects.||||||0.9138
72382963|NCT01086423|144274338|NON_INFERIORITY|Criterion for evaluation of Non-inferiority: The upper limit (UL) of the standardized asymptotic 95% confidence interval (CI) on the group difference \[Infanrix-Hib + Poliorix Group minus Infanrix-IPV+Hib 1 Group\] in percentage of seroprotected subjects ≤ 10%.|Difference in seroprotection rate|0.68|||||TWO_SIDED|95.0|-1.88|3.76||||||To demonstrate that the immunogenicity of Infanrix™ -IPV+Hib vaccine administered at 2, 3 and 4 months of age was non-inferior to that of the concomitant administration of Infanrix™-Hib and Poliorix™ vaccines at the same age, in terms of immune response to anti-D, one month after the third vaccine dose.||3.76|-1.88|
72382964|NCT01086423|144274338|NON_INFERIORITY|Criterion for evaluation of Non-inferiority: The UL of the standardized asymptotic 95% CI on the group difference \[Infanrix-Hib + Poliorix Group minus Infanrix-IPV+Hib 1 Group\] in percentage of seroprotected subjects ≤ 10%.|Difference in seroprotection rate|0.0|||||TWO_SIDED|95.0|-2.56|2.56||||||To demonstrate that the immunogenicity of Infanrix™-IPV+Hib vaccine administered at 2, 3 and 4 months of age was non-inferior to that of the concomitant administration of Infanrix™-Hib and Poliorix™ vaccines at the same age, in terms of immune response to anti-T, one month after the third vaccine dose.||2.56|-2.56|
72382965|NCT01086423|144274339|NON_INFERIORITY|Criterion for evaluation of Non-inferiority: The UL of the standardized asymptotic 95% CI on the group difference \[Infanrix-Hib + Poliorix Group minus Infanrix-IPV+Hib 1 Group\] in percentage of seroprotected subjects ≤ 10%.|Difference in seroprotection rate|-7.93|||||TWO_SIDED|95.0|-14.44|-2.13||||||To demonstrate that the immunogenicity of Infanrix™-IPV+Hib vaccine administered at 2, 3 and 4 months of age was non-inferior to that of the concomitant administration of Infanrix™-Hib and Poliorix™ vaccines at the same age, in terms of immune response to anti-PRP antibodies, one month after the third vaccine dose.||-2.13|-14.44|
72382966|NCT01086423|144274340|NON_INFERIORITY|Criterion for evaluation of Non-inferiority: The UL of the standardized asymptotic 95% CI on the group difference \[Infanrix-Hib + Poliorix Group minus Infanrix-IPV+Hib 1 Group\] in percentage of seroprotected subjects ≤ 10%.|Difference in seroprotection rate|0.0|||||TWO_SIDED|95.0|-2.51|2.56||||||To demonstrate that the immunogenicity of Infanrix™-IPV+Hib vaccine administered at 2, 3 and 4 months of age was non-inferior to that of the concomitant administration of Infanrix™-Hib and Poliorix™ vaccines at the same age, in terms of immune response to anti-Polio type 1 antibodies, one month after the third vaccine dose.||2.56|-2.51|
72434985|NCT00383188|144383168|SUPERIORITY||LSM Difference|-11.07|STANDARD_ERROR_OF_MEAN|3.983||0.0056|TWO_SIDED|95.0|-18.89|-3.251|||ANCOVA|||Week 12: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 12 as an interaction term, baseline Patient's Assessment of Arthritis Pain (VAS) count as the covariate and participant as a random effect.||-3.251|-18.89|0.0056
72557905|NCT00205777|144645457|SUPERIORITY_OR_OTHER|||||||0.76||95.0|||||ANOVA|||||||0.76
72557906|NCT00205777|144645457|SUPERIORITY_OR_OTHER|||||||0.26||95.0|||||ANOVA|||||||0.26
72557907|NCT00205777|144645457|SUPERIORITY_OR_OTHER|||||||0.9||95.0|||||ANOVA|||||||0.90
72557908|NCT00205777|144645457|SUPERIORITY_OR_OTHER|||||||0.16||95.0|||||ANOVA|||||||0.16
72557909|NCT00205777|144645458|SUPERIORITY_OR_OTHER|||||||0.41|TWO_SIDED||||||ANOVA|||||||0.41
72557910|NCT00205777|144645458|SUPERIORITY_OR_OTHER|||||||0.18||95.0|||||ANOVA|||||||0.18
72557911|NCT00205777|144645459|SUPERIORITY_OR_OTHER|||||||0.68|TWO_SIDED||||||ANOVA|||||||0.68
72557912|NCT00205777|144645459|SUPERIORITY_OR_OTHER|||||||0.97||95.0|||||ANOVA|||||||0.97
72557913|NCT00205777|144645459|SUPERIORITY_OR_OTHER|||||||0.18||95.0|||||ANOVA|||||||0.18
72557914|NCT00205777|144645459|SUPERIORITY_OR_OTHER|||||||0.088||95.0|||||ANOVA|||||||0.088
72557915|NCT00205777|144645459|SUPERIORITY_OR_OTHER|||||||0.17||95.0|||||ANOVA|||||||0.17
72557916|NCT00205777|144645460|SUPERIORITY_OR_OTHER|||||||0.25|TWO_SIDED||||||ANOVA|||||||0.25
72494160|NCT03237065|144517215|SUPERIORITY||Mean Difference (Final Values)|0.05||||0.2376|TWO_SIDED|95.0|-0.03|0.12|||Mixed model for repeated measures|||"Day 35~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||0.12|-0.03|0.2376
72494161|NCT03237065|144517217|SUPERIORITY||Mean Difference (Final Values)|-0.31||||0.0882|TWO_SIDED|95.0|-0.67|0.05|||Mixed model for repeated measures|||"Day 1~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||0.05|-0.67|0.0882
72494162|NCT03237065|144517217|SUPERIORITY||Mean Difference (Final Values)|-0.34||||0.0941|TWO_SIDED|95.0|-0.74|0.06|||Mixed model for repeated measures|||"Day 7~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||0.06|-0.74|0.0941
72494163|NCT03237065|144517217|SUPERIORITY||Mean Difference (Final Values)|0.32||||0.0628|TWO_SIDED|95.0|-0.02|0.66|||Mixed model for repeated measures|||"Day 8~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||0.66|-0.02|0.0628
72494164|NCT03237065|144517217|SUPERIORITY||Mean Difference (Final Values)|0.46||||0.0056|TWO_SIDED|95.0|0.14|0.79|||Mixed model for repeated measures|||"Day 14~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||0.79|0.14|0.0056
72494165|NCT03237065|144517217|SUPERIORITY||Mean Difference (Final Values)|0.28||||0.0492|TWO_SIDED|95.0|0.0|0.55|||Mixed model for repeated measures|||"Day 21~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||0.55|0.00|0.0492
72494166|NCT03237065|144517217|SUPERIORITY||Mean Difference (Final Values)|0.3||||0.0882|TWO_SIDED|95.0|-0.05|0.64|||Mixed model for repeated measures|||"Day 35~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||0.64|-0.05|0.0882
72494167|NCT03237065|144517218|SUPERIORITY||Mean Difference (Final Values)|-6.5||||0.6568|TWO_SIDED|95.0|-35.3|22.3|||Mixed model for repeated measures|||"Day 1~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||22.3|-35.3|0.6568
72618717|NCT01026038|144768108|SUPERIORITY_OR_OTHER||GMT ratio|0.2|||||TWO_SIDED|95.0|0.05|0.85||||||Serotype 19A: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||0.85|0.05|
72494168|NCT03237065|144517218|SUPERIORITY||Mean Difference (Final Values)|-24.2||||0.4929|TWO_SIDED|95.0|-94.0|45.5|||Mixed model for repeated measures|||"Day 7~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||45.5|-94.0|0.4929
72494169|NCT03237065|144517218|SUPERIORITY||Mean Difference (Final Values)|-91.7||||0.0113|TWO_SIDED|95.0|-162.3|-21.1|||Mixed model for repeated measures|||"Day 8~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||-21.1|-162.3|0.0113
72494170|NCT03237065|144517218|SUPERIORITY||Mean Difference (Final Values)|-240.4|||<|0.0001|TWO_SIDED|95.0|-318.4|-162.3|||Mixed model for repeated measures|||"Day 14~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||-162.3|-318.4|<0.0001
72557917|NCT00205777|144645460|SUPERIORITY_OR_OTHER|||||||0.1||95.0|||||ANOVA|||||||0.10
72557918|NCT00205777|144645461|SUPERIORITY_OR_OTHER|||||||0.9|TWO_SIDED||||||ANOVA|||||||0.90
72557919|NCT00205777|144645461|SUPERIORITY_OR_OTHER|||||||0.74||95.0|||||ANOVA|||||||0.74
72618718|NCT01026038|144768109|SUPERIORITY_OR_OTHER||GMT Ratio|1.0|||||TWO_SIDED|95.0|0.8|1.38||||||Serotype 4: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||1.38|0.80|
72494171|NCT03237065|144517218|SUPERIORITY||Mean Difference (Final Values)|-135.1|||<|0.0001|TWO_SIDED|95.0|-196.1|-74.0|||Mixed model for repeated measures|||"Day 21~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||-74.0|-196.1|<0.0001
72494172|NCT03237065|144517218|SUPERIORITY||Mean Difference (Final Values)|-67.7||||0.0039|TWO_SIDED|95.0|-113.2|-22.2|||Mixed model for repeated measures|||"Day 35~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||-22.2|-113.2|0.0039
72494173|NCT03237065|144517219|SUPERIORITY||Mean Difference (Final Values)|24.2||||0.0503|TWO_SIDED|95.0|0.0|48.5|||Mixed model for repeated measures|||"Day 1~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||48.5|-0.0|0.0503
72494174|NCT03237065|144517219|SUPERIORITY||Mean Difference (Final Values)|2.2||||0.5794|TWO_SIDED|95.0|-5.5|9.8|||Mixed model for repeated measures|||"Day 7~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||9.8|-5.5|0.5794
72494175|NCT03237065|144517219|SUPERIORITY||Mean Difference (Final Values)|-62.2|||<|0.0001|TWO_SIDED|95.0|-70.1|-54.3|||Mixed model for repeated measures|||"Day 8~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||-54.3|-70.1|<0.0001
72494176|NCT03237065|144517219|SUPERIORITY||Mean Difference (Final Values)|-6.9||||0.0001|TWO_SIDED|95.0|-10.4|-3.5|||Mixed model for repeated measures|||"Day 14~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||-3.5|-10.4|0.0001
72494177|NCT03237065|144517219|SUPERIORITY||Mean Difference (Final Values)|-5.8||||0.0008|TWO_SIDED|95.0|-9.1|-2.4|||Mixed model for repeated measures|||"Day 21~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||-2.4|-9.1|0.0008
72494178|NCT03237065|144517219|SUPERIORITY||Mean Difference (Final Values)|-4.8||||0.004|TWO_SIDED|95.0|-8.1|-1.6|||Mixed model for repeated measures|||"Day 35~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||-1.6|-8.1|0.0040
72494179|NCT03237065|144517220|SUPERIORITY||Risk Difference (RD)|-10.7||||0.009|TWO_SIDED|95.0|-18.8|-2.6|||Cochran-Mantel-Haenszel|||The rate difference with 95% Newcombe confidence interval, adjusted for stratum using the Cochran-Mantel-Haenszel method, could not be estimated due to lack of events. Thus, the unadjusted treatment difference is presented together with 95% Wald-based confidence interval. The p-value is based on the Cochran-Mantel-Haenszel statistics.||-2.6|-18.8|0.0090
72494180|NCT01764633|144517300|SUPERIORITY||Hazard Ratio (HR)|0.85|||<|0.0001|TWO_SIDED|95.0|0.79|0.92|||Log Rank|Two-sided log-rank test stratified by randomization stratification factors (final screening LDL-C level and region).|Based on a Cox model stratified by the randomization stratification factors.|The primary endpoint was compared between treatment groups at a significance level of 0.05.||0.92|0.79|< 0.0001
72494181|NCT01764633|144517301|SUPERIORITY||Hazard Ratio (HR)|0.8|||<|0.0001|TWO_SIDED|95.0|0.73|0.88|||Log Rank|Two-sided log-rank test stratified by randomization stratification factors (final screening LDL-C level and region).|Based on a Cox model stratified by the randomization stratification factors.|If the primary endpoint reached statistical significance at the 0.05 level, the key secondary endpoint (composite of cardiovascular death, myocardial infarction, and stroke) was tested at a significance level of 0.05.||0.88|0.73|< 0.0001
72494182|NCT01764633|144517302|SUPERIORITY||Hazard Ratio (HR)|1.05||||0.6188|TWO_SIDED|95.0|0.88|1.25|||Log Rank|Two-sided log-rank test stratified by randomization stratification factors (final screening LDL-C level and region).|Based on a Cox model stratified by the randomization stratification factors.|If the primary and key secondary endpoints reached a statistical significance level of 0.05, then the endpoint of cardiovascular death was tested at a significance level of 0.05.||1.25|0.88|0.6188
72494183|NCT01764633|144517303|SUPERIORITY||Hazard Ratio (HR)|1.04||||0.5368|TWO_SIDED|95.0|0.91|1.19|||Log Rank|Two-sided log-rank test stratified by randomization stratification factors (final screening LDL-C level and region).|Based on a Cox model stratified by the randomization stratification factors.|If the primary, key secondary, and endpoint cardiovascular death reached a statistical significance level of 0.05, then the endpoint of all-cause death was tested at a significance level of 0.04 and remaining secondary endpoints at an overall significant level of 0.01 by applying the Hochberg method.||1.19|0.91|0.5368
72494184|NCT01764633|144517304|SUPERIORITY||Hazard Ratio (HR)|0.73|||<|0.0001|TWO_SIDED|95.0|0.65|0.82|||Log Rank|Two-sided log-rank test stratified by randomization stratification factors (final screening LDL-C level and region).|Based on a Cox model stratified by the randomization stratification factors.|If the primary, key secondary, and endpoint of cardiovascular death reached a statistical significance level of 0.05, then the endpoint of all-cause death was tested at a significance level of 0.04 and remaining secondary endpoints were tested at an overall significance level of 0.01 by applying the Hochberg method.||0.82|0.65|< 0.0001
72494185|NCT01764633|144517305|SUPERIORITY||Hazard Ratio (HR)|0.79||||0.0101|TWO_SIDED|95.0|0.66|0.95|||Log Rank|Two-sided log-rank test stratified by randomization stratification factors (final screening LDL-C level and region).|Based on a Cox model stratified by the randomization stratification factors.|If the primary, key secondary, and endpoint of cardiovascular death reached a statistical significance level of 0.05, then the endpoint of all-cause death was tested at a significance level of 0.04 and remaining secondary endpoints were tested at an overall significance level of 0.01 by applying the Hochberg method.||0.95|0.66|0.0101
72494186|NCT01764633|144517306|SUPERIORITY||Hazard Ratio (HR)|0.78|||<|0.0001|TWO_SIDED|95.0|0.71|0.86|||Log Rank|Two-sided log-rank test stratified by randomization stratification factors (final screening LDL-C level and region).|Based on a Cox model stratified by the randomization stratification factors.|If the primary, key secondary, and endpoint of cardiovascular death reached a statistical significance level of 0.05, then the endpoint of all-cause death was tested at a significance level of 0.04 and remaining secondary endpoints were tested at an overall significance level of 0.01 by applying the Hochberg method.||0.86|0.71|< 0.0001
72494187|NCT01764633|144517307|SUPERIORITY||Hazard Ratio (HR)|0.98||||0.8179|TWO_SIDED|95.0|0.86|1.13|||Log Rank|Two-sided log-rank test stratified by randomization stratification factors (final screening LDL-C level and region).|Based on a Cox model stratified by the randomization stratification factors.|If the primary, key secondary, and endpoint of cardiovascular death reached a statistical significance level of 0.05, then the endpoint of all-cause death was tested at a significance level of 0.04 and remaining secondary endpoints were tested at an overall significance level of 0.01 by applying the Hochberg method.||1.13|0.86|0.8179
72434986|NCT00383188|144383168|SUPERIORITY||LSM Difference|-8.885|STANDARD_ERROR_OF_MEAN|4.654||0.0566|TWO_SIDED|95.0|-18.02|0.251|||ANCOVA|||Week 12: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 12 as an interaction term, baseline Patient's Assessment of Arthritis Pain (VAS) count as the covariate and participant as a random effect.||0.251|-18.02|0.0566
72434987|NCT00383188|144383168|SUPERIORITY||LSM Difference|-10.09|STANDARD_ERROR_OF_MEAN|4.772||0.0348|TWO_SIDED|95.0|-19.45|-0.72|||ANCOVA|||Week 12: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 12 as an interaction term, baseline Patient's Assessment of Arthritis Pain (VAS) count as the covariate and participant as a random effect.||-0.720|-19.45|0.0348
72434988|NCT00383188|144383168|SUPERIORITY||LSM Difference|4.89|STANDARD_ERROR_OF_MEAN|4.191||0.2436|TWO_SIDED|95.0|-3.336|13.116|||ANCOVA|||Week 16: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 16 as an interaction term, baseline Patient's Assessment of Arthritis Pain (VAS) count as the covariate and participant as a random effect.||13.116|-3.336|0.2436
72434989|NCT00383188|144383168|SUPERIORITY||LSM Difference|-1.781|STANDARD_ERROR_OF_MEAN|4.066||0.6616|TWO_SIDED|95.0|-9.762|6.201|||ANCOVA|||Week 16: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 16 as an interaction term, baseline Patient's Assessment of Arthritis Pain (VAS) count as the covariate and participant as a random effect.||6.201|-9.762|0.6616
72494188|NCT01764633|144517308|SUPERIORITY||Hazard Ratio (HR)|0.77||||0.0035|TWO_SIDED|95.0|0.65|0.92|||Log Rank|Two-sided log-rank test stratified by randomization stratification factors (final screening LDL-C level and region).|Based on a Cox model stratified by the randomization stratification factors.|If the primary, key secondary, and endpoint of cardiovascular death reached a statistical significance level of 0.05, then the endpoint of all-cause death was tested at a significance level of 0.04 and remaining secondary endpoints were tested at an overall significance level of 0.01 by applying the Hochberg method.||0.92|0.65|0.0035
72494189|NCT04418765|144517313|OTHER|Testing sequence: 1. Change in MMDs (Weeks 1-12) 300 mg vs placebo; 2. 50% responders for MMDs (Weeks 1-12) 300 mg vs placebo; 3. Change in MMDs (Weeks 1-12) 100 mg vs placebo; 4. 50% responders for MMDs (Weeks 1-12) 100 mg vs placebo; 5a. Change in MMDs (Weeks 13-24), 5b. 75% responders for MMDs (Weeks 1-12), 5c. Change in HIT-6 (Week 12) 300 mg vs placebo; 6a. Change in MMDs (Weeks 13-24), 6b. 75% responders for MMDs (Weeks 1-12), 6c. Change in HIT-6 (Week 12) 100 mg vs placebo.|Mean Difference (Final Values)|-3.2|STANDARD_ERROR_OF_MEAN|0.36|<|0.0001|TWO_SIDED|95.0|-3.9|-2.5||Testing continued only, if the previous comparison was statistically significant. Threshold for significance: p-value \<α, where α = 0.05. Here it is test no. 1 of testing order.|Mixed Models Analysis|||Analysis was performed using a restricted maximum likelihood (REML)-based mixed model for repeated measurements (MMRM) with month (Weeks 1-4, 5-8, 9-12, 13-16, 17-20, 21-24), country, stratification factor (monthly MHDs at baseline: ≤14/\>14) and treatment as factors, baseline score as a continuous covariate, treatment-by-month interaction, baseline score-by-month interaction, and stratum-by-month interaction. A testing strategy was applied to ensure protection of the type 1 error.||-2.5|-3.9|<0.0001
72382967|NCT01086423|144274340|NON_INFERIORITY|Criterion for evaluation of Non-inferiority: The UL of the standardized asymptotic 95% CI on the group difference \[Infanrix-Hib + Poliorix Group minus Infanrix-IPV+Hib 1 Group\] in percentage of seroprotected subjects ≤ 10%.|Difference in seroprotection rate|0.0|||||TWO_SIDED|95.0|-2.51|2.56||||||To demonstrate that the immunogenicity of Infanrix™-IPV+Hib vaccine administered at 2, 3 and 4 months of age was non-inferior to that of the concomitant administration of Infanrix™-Hib and Poliorix™ vaccines at the same age, in terms of immune response to anti-Polio type 2 antibodies, one month after the third vaccine dose.||2.56|-2.51|
72382968|NCT01086423|144274340|NON_INFERIORITY|Criterion for evaluation of Non-inferiority: The UL of the standardized asymptotic 95% CI on the group difference \[Infanrix-Hib + Poliorix Group minus Infanrix-IPV+Hib 1 Group\] in percentage of seroprotected subjects ≤ 10%.|Difference in seroprotection rate|0.0|||||TWO_SIDED|95.0|-2.51|2.56||||||To demonstrate that the immunogenicity of Infanrix™-IPV+Hib vaccine administered at 2, 3 and 4 months of age was non-inferior to that of the concomitant administration of Infanrix™-Hib and Poliorix™ vaccines at the same age, in terms of immune response to anti-Polio type 3 antibodies, one month after the third vaccine dose.||2.56|-2.51|
72434990|NCT00383188|144383168|SUPERIORITY||LSM Difference|3.907|STANDARD_ERROR_OF_MEAN|4.83||0.4189|TWO_SIDED|95.0|-5.574|13.388|||ANCOVA|||Week 16: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 16 as an interaction term, baseline Patient's Assessment of Arthritis Pain (VAS) count as the covariate and participant as a random effect.||13.388|-5.574|0.4189
72434991|NCT00383188|144383168|SUPERIORITY||LSM Difference|4.395|STANDARD_ERROR_OF_MEAN|4.942||0.3741|TWO_SIDED|95.0|-5.305|14.096|||ANCOVA|||Week 16: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 16 as an interaction term, baseline Patient's Assessment of Arthritis Pain (VAS) count as the covariate and participant as a random effect.||14.096|-5.305|0.3741
72434992|NCT00383188|144383169|SUPERIORITY||LSM Difference|-2.996|STANDARD_ERROR_OF_MEAN|3.958||0.4493|TWO_SIDED|95.0|-10.77|4.773|||ANCOVA|||Week 1: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 1 as an interaction term, baseline Patient's Global Assessment of Arthritis count as the covariate and participant as a random effect.||4.773|-10.77|0.4493
72434993|NCT00383188|144383169|SUPERIORITY||LSM Difference|-14.45|STANDARD_ERROR_OF_MEAN|3.891||0.0002|TWO_SIDED|95.0|-22.08|-6.807|||ANCOVA|||Week 1: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 1 as an interaction term, baseline Patient's Global Assessment of Arthritis count as the covariate and participant as a random effect.||-6.807|-22.08|0.0002
72434994|NCT00383188|144383169|SUPERIORITY||LSM Difference|-11.54|STANDARD_ERROR_OF_MEAN|4.522||0.0109|TWO_SIDED|95.0|-20.42|-2.661|||ANCOVA|||Week 1: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 1 as an interaction term, baseline Patient's Global Assessment of Arthritis count as the covariate and participant as a random effect.||-2.661|-20.42|0.0109
72434995|NCT00383188|144383169|SUPERIORITY||LSM Difference|-7.364|STANDARD_ERROR_OF_MEAN|4.651||0.1137|TWO_SIDED|95.0|-16.49|1.765|||ANCOVA|||Week 1: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 1 as an interaction term, baseline Patient's Global Assessment of Arthritis count as the covariate and participant as a random effect.||1.765|-16.49|0.1137
72434996|NCT00383188|144383169|SUPERIORITY||LSM Difference|-3.989|STANDARD_ERROR_OF_MEAN|3.915||0.3086|TWO_SIDED|95.0|-11.68|3.697|||ANCOVA|||Week 2: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 2 as an interaction term, baseline Patient's Global Assessment of Arthritis count as the covariate and participant as a random effect.||3.697|-11.68|0.3086
72434997|NCT00383188|144383169|SUPERIORITY||LSM Difference|-8.357|STANDARD_ERROR_OF_MEAN|3.85||0.0303|TWO_SIDED|95.0|-15.92|-0.799|||ANCOVA|||Week 2: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 2 as an interaction term, baseline Patient's Global Assessment of Arthritis count as the covariate and participant as a random effect.||-0.799|-15.92|0.0303
72434998|NCT00383188|144383169|SUPERIORITY||LSM Difference|-10.66|STANDARD_ERROR_OF_MEAN|4.489||0.0178|TWO_SIDED|95.0|-19.47|-1.845|||ANCOVA|||Week 2: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 2 as an interaction term, baseline Patient's Global Assessment of Arthritis count as the covariate and participant as a random effect.||-1.845|-19.47|0.0178
72434999|NCT00383188|144383169|SUPERIORITY||LSM Difference|-5.325|STANDARD_ERROR_OF_MEAN|4.612||0.2486|TWO_SIDED|95.0|-14.38|3.729|||ANCOVA|||Week 2: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 2 as an interaction term, baseline Patient's Global Assessment of Arthritis count as the covariate and participant as a random effect.||3.729|-14.38|0.2486
72435000|NCT00383188|144383169|SUPERIORITY||LSM Difference|-2.965|STANDARD_ERROR_OF_MEAN|3.915||0.4491|TWO_SIDED|95.0|-10.65|4.72|||ANCOVA|||Week 4: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 4 as an interaction term, baseline Patient's Global Assessment of Arthritis count as the covariate and participant as a random effect.||4.720|-10.65|0.4491
72504532|NCT00906789|144539803|NON_INFERIORITY_OR_EQUIVALENCE|Given a continuous confidence score (0-100), the trapezoidal method was used to obtain the area under the LROC with bootstrapping at 10,000 iterations to obtain the 95% confidence interval (CI). Acceptance criteria for tests of non-inferiority and superiority were previously set at 95% CI upper bound of ΔAUCUA-SV less than δ=0.1 and δ=0, respectively. If the 95% CI upper bound difference of UA-SV is less than 0.1, then SV is non-inferior. If it is 0 or less than 0, then SV is superior.||||||0.05|||||||Bootstraping|||The sample size of 351 patients, in a 2:1 ratio of nodule absent to present patients was selected to provide 80% power to detect a difference in areas under the curve of 0.10 or greater. This sample size was calculated using PASS software (Hintze, 2008). Settings: • α = 0.025. • one-sided test • AUCA = 0.80 and AUCSV = 0.90.• 2:1 ratio of patients with nodules to those without • areas calculated for the entire curves • correlation 0.3\* • discrete data. • standard deviation ratios of 1\*.||||0.05
72504533|NCT02334267|144539806|SUPERIORITY_OR_OTHER||||||<|0.0001||||||trend analysis over time|Mixed Models Analysis|||||||<0.0001
72435001|NCT00383188|144383169|SUPERIORITY||LSM Difference|-10.23|STANDARD_ERROR_OF_MEAN|3.85||0.0081|TWO_SIDED|95.0|-17.79|-2.671|||ANCOVA|||Week 4: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 4 as an interaction term, baseline Patient's Global Assessment of Arthritis count as the covariate and participant as a random effect.||-2.671|-17.79|0.0081
72435002|NCT00383188|144383169|SUPERIORITY||LSM Difference|-9.291|STANDARD_ERROR_OF_MEAN|4.488||0.0388|TWO_SIDED|95.0|-18.1|-0.48|||ANCOVA|||Week 4: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 4 as an interaction term, baseline Patient's Global Assessment of Arthritis count as the covariate and participant as a random effect.||-0.480|-18.10|0.0388
72435003|NCT00383188|144383169|SUPERIORITY||LSM Difference|-2.5|STANDARD_ERROR_OF_MEAN|4.611||0.588|TWO_SIDED|95.0|-11.55|6.553|||ANCOVA|||Week 4: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 4 as an interaction term, baseline Patient's Global Assessment of Arthritis count as the covariate and participant as a random effect.||6.553|-11.55|0.5880
72504534|NCT02334267|144539807|SUPERIORITY_OR_OTHER|||||||0.4||||||trend analysis over time|Mixed Models Analysis|||||||0.4
72382969|NCT01086423|144274341|NON_INFERIORITY|Criterion for evaluation of Non-inferiority: The UL of the standardized asymptotic 95% CI on the group difference \[Infanrix-Hib + Poliorix Group minus Infanrix-IPV+Hib 1 Group\] in percentage of seroprotected subjects ≤ 10%.|Difference in seroprotection rate|-0.68|||||TWO_SIDED|95.0|-3.74|1.89||||||To demonstrate that the immunogenicity of Infanrix™-IPV+Hib vaccine administered at 2, 3 and 4 months of age was non-inferior to that of the concomitant administration of Infanrix™-Hib and Poliorix™ vaccines at the same age, in terms of immune response to anti-PT antigens, one month after the third vaccine dose.||1.89|-3.74|
72382970|NCT01086423|144274341|NON_INFERIORITY|Criterion for evaluation of Non-inferiority: The UL of the standardized asymptotic 95% CI on the group difference \[Infanrix-Hib + Poliorix Group minus Infanrix-IPV+Hib 1 Group\] in percentage of seroprotected subjects ≤ 10%.|Difference in seroprotection rate|-2.7|||||TWO_SIDED|95.0|-6.75|-0.11||||||To demonstrate that the immunogenicity of Infanrix™-IPV+Hib vaccine administered at 2, 3 and 4 months of age was non-inferior to that of the concomitant administration of Infanrix™-Hib and Poliorix™ vaccines at the same age, in terms of immune response to anti-FHA antigens, one month after the third vaccine dose.||-0.11|-6.75|
72382971|NCT01086423|144274341|NON_INFERIORITY|Criterion for evaluation of Non-inferiority: The UL of the standardized asymptotic 95% confidence interval (CI) on the group difference \[Infanrix-Hib + Poliorix Group minus Infanrix-IPV+Hib 1 Group\] in percentage of seroprotected subjects ≤ 10%.|Difference in seroprotection rate|-0.67|||||TWO_SIDED|95.0|-4.6|3.04||||||To demonstrate that the immunogenicity of Infanrix™-IPV+Hib vaccine administered at 2, 3 and 4 months of age was non-inferior to that of the concomitant administration of Infanrix™-Hib and Poliorix™ vaccines at the same age, in terms of immune response to anti-PRN antigens, one month after the third vaccine dose.||3.04|-4.6|
72382972|NCT00749515|144274358|OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<.001
72435004|NCT00383188|144383169|SUPERIORITY||LSM Difference|3.78|STANDARD_ERROR_OF_MEAN|3.914||0.3345|TWO_SIDED|95.0|-3.904|11.464|||ANCOVA|||Week 8: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 8 as an interaction term, baseline Patient's Global Assessment of Arthritis count as the covariate and participant as a random effect.||11.464|-3.904|0.3345
72435005|NCT00383188|144383169|SUPERIORITY||LSM Difference|-9.019|STANDARD_ERROR_OF_MEAN|3.849||0.0194|TWO_SIDED|95.0|-16.58|-1.463|||ANCOVA|||Week 8: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 8 as an interaction term, baseline Patient's Global Assessment of Arthritis count as the covariate and participant as a random effect.||-1.463|-16.58|0.0194
72435006|NCT00383188|144383169|SUPERIORITY||LSM Difference|-5.946|STANDARD_ERROR_OF_MEAN|4.488||0.1855|TWO_SIDED|95.0|-14.76|2.863|||ANCOVA|||Week 8: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 8 as an interaction term, baseline Patient's Global Assessment of Arthritis count as the covariate and participant as a random effect.||2.863|-14.76|0.1855
72435007|NCT00383188|144383169|SUPERIORITY||LSM Difference|-5.249|STANDARD_ERROR_OF_MEAN|4.611||0.2553|TWO_SIDED|95.0|-14.3|3.803|||ANCOVA|||Week 8: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 8 as an interaction term, baseline Patient's Global Assessment of Arthritis count as the covariate and participant as a random effect.||3.803|-14.30|0.2553
72435008|NCT00383188|144383169|SUPERIORITY||LSM Difference|-4.041|STANDARD_ERROR_OF_MEAN|3.912||0.302|TWO_SIDED|95.0|-11.72|3.639|||ANCOVA|||Week 12: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 12 as an interaction term, baseline Patient's Global Assessment of Arthritis count as the covariate and participant as a random effect.||3.639|-11.72|0.3020
72435009|NCT00383188|144383169|SUPERIORITY||LSM Difference|-10.27|STANDARD_ERROR_OF_MEAN|3.847||0.0078|TWO_SIDED|95.0|-17.82|-2.715|||ANCOVA|||Week 12: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 12 as an interaction term, baseline Patient's Global Assessment of Arthritis count as the covariate and participant as a random effect.||-2.715|-17.82|0.0078
72435010|NCT00383188|144383169|SUPERIORITY||LSM Difference|-8.522|STANDARD_ERROR_OF_MEAN|4.486||0.0578|TWO_SIDED|95.0|-17.33|0.284|||ANCOVA|||Week 12: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 12 as an interaction term, baseline Patient's Global Assessment of Arthritis count as the covariate and participant as a random effect.||0.284|-17.33|0.0578
72435011|NCT00383188|144383169|SUPERIORITY||LSM Difference|-7.042|STANDARD_ERROR_OF_MEAN|4.61||0.127|TWO_SIDED|95.0|-16.09|2.007|||ANCOVA|||Week 12: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 12 as an interaction term, baseline Patient's Global Assessment of Arthritis count as the covariate and participant as a random effect.||2.007|-16.09|0.1270
72435012|NCT00383188|144383169|SUPERIORITY||LSM Difference|5.927|STANDARD_ERROR_OF_MEAN|4.051||0.1438|TWO_SIDED|95.0|-2.023|13.877|||ANCOVA|||Week 16: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 16 as an interaction term, baseline Patient's Global Assessment of Arthritis count as the covariate and participant as a random effect.||13.877|-2.023|0.1438
72435013|NCT00383188|144383169|SUPERIORITY||LSM Difference|-1.979|STANDARD_ERROR_OF_MEAN|3.931||0.6149|TWO_SIDED|95.0|-9.696|5.738|||ANCOVA|||Week 16: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 16 as an interaction term, baseline Patient's Global Assessment of Arthritis count as the covariate and participant as a random effect.||5.738|-9.696|0.6149
72504535|NCT02334267|144539808|SUPERIORITY_OR_OTHER|||||||0.003||||||trend analysis over time|Mixed Models Analysis|||||||0.003
72504536|NCT02334267|144539809|SUPERIORITY_OR_OTHER||||||<|0.0001||||||trend analysis over time|Mixed Models Analysis|||||||<0.0001
72504537|NCT00923091|144539810|SUPERIORITY_OR_OTHER|||||||0.0071||95.0|||||ANCOVA|||||||0.0071
72504538|NCT00923091|144539810|SUPERIORITY_OR_OTHER|||||||0.0323||95.0|||||ANCOVA|||||||0.0323
72504539|NCT00923091|144539810|SUPERIORITY_OR_OTHER|||||||0.008||95.0|||||ANCOVA|||||||0.0080
72504540|NCT00923091|144539810|SUPERIORITY_OR_OTHER|||||||0.0071||95.0|||||ANCOVA|||||||0.0071
72435014|NCT00383188|144383169|SUPERIORITY||LSM Difference|6.545|STANDARD_ERROR_OF_MEAN|4.664||0.1609|TWO_SIDED|95.0|-2.61|15.7|||ANCOVA|||Week 16: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 16 as an interaction term, baseline Patient's Global Assessment of Arthritis count as the covariate and participant as a random effect.||15.700|-2.610|0.1609
72435015|NCT00383188|144383169|SUPERIORITY||LSM Difference|6.579|STANDARD_ERROR_OF_MEAN|4.78||0.1691|TWO_SIDED|95.0|-2.804|15.961|||ANCOVA|||Week 16: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 16 as an interaction term, baseline Patient's Global Assessment of Arthritis count as the covariate and participant as a random effect.||15.961|-2.804|0.1691
72435016|NCT00383188|144383170|SUPERIORITY||LSM Difference|-1.409|STANDARD_ERROR_OF_MEAN|3.341||0.6733|TWO_SIDED|95.0|-7.967|5.149|||ANCOVA|||Week 1: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 1 as an interaction term, baseline Physician's Global Assessment of Arthritis count as the covariate and participant as a random effect.||5.149|-7.967|0.6733
72435017|NCT00383188|144383170|SUPERIORITY||LSM Difference|-5.629|STANDARD_ERROR_OF_MEAN|3.274||0.0859|TWO_SIDED|95.0|-12.05|0.797|||ANCOVA|||Week 1: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 1 as an interaction term, baseline Physician's Global Assessment of Arthritis count as the covariate and participant as a random effect.||0.797|-12.05|0.0859
72382973|NCT00749515|144274359|OTHER|||||||0.275|||||||t-test, 2 sided|||||||.275
72382974|NCT00749515|144274360|OTHER|||||||0.178|||||||t-test, 2 sided|||||||.178
72382975|NCT00749515|144274361|OTHER|||||||0.062|||||||t-test, 2 sided|||||||.062
72382976|NCT00749515|144274362|OTHER|||||||0.104|||||||t-test, 2 sided|||||||.104
72382977|NCT00277446|144274368|SUPERIORITY_OR_OTHER||||||<|0.03||95.0|||||t-test, 2 sided|||"The two groups tested were baseline and after 4 weeks of treatment with the soy isoflavone supplement."||||<0.03
72382978|NCT00277446|144274369|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED|95.0|||||t-test, 2 sided|||"The two groups tested were baseline and after 4 weeks of treatment with the soy isoflavone supplement."||||0.02
72382979|NCT00277446|144274370|SUPERIORITY_OR_OTHER|||||||0.88||95.0|||||t-test, 2 sided|||"The two groups tested were baseline and after 4 weeks of treatment with the soy isoflavone supplement."||||0.88
72382980|NCT02001181|144274395|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-51.8|STANDARD_ERROR_OF_MEAN|8.48|<|0.0001|TWO_SIDED|80.0|-62.8|-40.8|||Mixed Models Analysis|The mixed model for repeated measures analysis included all the participants in FAS.||||-40.8|-62.8|<0.0001
72382981|NCT01842815|144274400|SUPERIORITY|||||||0.0077||||||The value looked at for statistical significance is if p\<.05.|t-test, 2 sided|t-tailed, paired t-test||This t-test is to test the statistical significance of the right side of the tattoo clearance vs. the left side of the tattoo clearance. It tests if there is a difference between the tattoo being treated twice per visit (right side) vs. being treated once per visit (left side).||||.0077
72382982|NCT01842815|144274401|SUPERIORITY|||||||0.00012||||||The value looked at for statistical significance is if p\<.05.|t-test, 2 sided|t-tailed, paired t-test||This t-test is to test the statistical significance of the right side of the tattoo clearance vs. the left side of the tattoo clearance. It tests if there is a difference between the tattoo being treated twice per visit (right side) vs. being treated once per visit (left side).||||.00012
72382983|NCT01842815|144274402|SUPERIORITY|||||||0.0034||||||The value looked at for statistical significance is if p\<.05.|t-test, 2 sided|t-tailed, paired t-test||This t-test is to test the statistical significance of the right side of the tattoo clearance vs. the left side of the tattoo clearance. It tests if there is a difference between the tattoo being treated twice per visit (right side) vs. being treated once per visit (left side).||||.0034
72382984|NCT04755283|144274424|SUPERIORITY||Hazard Ratio (HR)|0.314|||<|0.001|TWO_SIDED|95.0|0.192|0.513|||Stratified Log Rank Test|Stratified for stratification factors|Cox Proportional Hazards Model Adjusted for Stratification Factors|||0.513|0.192|<0.001
72382985|NCT04755283|144274424|SUPERIORITY||Hazard Ratio (HR)|0.382|||<|0.001|TWO_SIDED|95.0|0.243|0.602|||Stratified Log Rank Test|Stratified for stratification factors|Cox Proportional Hazards Model Adjusted for Stratification Factors|||0.602|0.243|<0.001
72382986|NCT04755283|144274425|SUPERIORITY||Hazard Ratio (HR)|0.263|||<|0.001|TWO_SIDED|95.0|0.121|0.572|||Stratified Log Rank Test|Stratified for stratification factors|Cox Proportional Hazards Model Adjusted for Stratification Factors|||0.572|0.121|<0.001
72382987|NCT04755283|144274425|SUPERIORITY||Hazard Ratio (HR)|0.325||||0.001|TWO_SIDED|95.0|0.159|0.663|||Stratified Log Rank Test|Stratified for stratification factors|Cox Proportional Hazards Model Adjusted for Stratification Factors|||0.663|0.159|0.001
72382988|NCT04755283|144274426|SUPERIORITY||Hazard Ratio (HR)|0.46|||<|0.001|TWO_SIDED|95.0|0.332|0.638|||Stratified Log Rank Test|Stratified for stratification factors|Cox Proportional Hazards Model Adjusted for Stratification Factors|||0.638|0.332|<0.001
72382989|NCT04755283|144274426|SUPERIORITY||Hazard Ratio (HR)|0.683||||0.01|TWO_SIDED|95.0|0.512|0.912|||Stratified Log Rank Test|Stratified for stratification factors|Cox Proportional Hazards Model Adjusted for Stratification Factors|||0.912|0.512|0.010
72382990|NCT05597020|144274427|SUPERIORITY||Least Square mean difference vs placebo|20.9||||0.002|TWO_SIDED|95.0|8.0|33.7|||Mixed Models Analysis|Treatment, period, week within period, and interaction of treatment and week were factors; baseline sTST assessment was covariate.||||33.7|8.0|0.002
72382991|NCT05169567|144274429|SUPERIORITY||Hazard Ratio (HR)|0.73||||0.02|TWO_SIDED|95.0|0.57|0.95|||Log Rank|||||0.95|0.57|0.02
72382992|NCT01015131|144274433|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.1521|||<|0.01|TWO_SIDED|90.0|0.0932|0.2111|||paired t-test|||||0.2111|0.0932|<0.01
72382993|NCT03029702|144274445|SUPERIORITY|||||||0.9|||||||Fisher Exact|||||||0.9
72382994|NCT03029702|144274446|SUPERIORITY|||||||0.8|||||||Fisher Exact|||||||0.8
72382995|NCT03029702|144274447|SUPERIORITY|||||||0.9|||||||Fisher Exact|||||||0.9
72382996|NCT03029702|144274448|SUPERIORITY|||||||0.9|||||||Fisher Exact|||||||0.9
72382997|NCT03029702|144274449|SUPERIORITY|||||||0.8|||||||Fisher Exact|||||||0.8
72382998|NCT03029702|144274450|SUPERIORITY|||||||0.6|||||||Chi-squared|||||||0.6
72382999|NCT03029702|144274451|SUPERIORITY|||||||0.8|||||||Chi-squared|||||||0.8
72383000|NCT03029702|144274452|SUPERIORITY|||||||0.7|||||||t-test, 2 sided|||||||0.7
72435018|NCT00383188|144383170|SUPERIORITY||LSM Difference|-9.718|STANDARD_ERROR_OF_MEAN|3.8||0.0107|TWO_SIDED|95.0|-17.18|-2.259|||ANCOVA|||Week 1: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 1 as an interaction term, baseline Physician's Global Assessment of Arthritis count as the covariate and participant as a random effect.||-2.259|-17.18|0.0107
72435019|NCT00383188|144383170|SUPERIORITY||LSM Difference|-3.695|STANDARD_ERROR_OF_MEAN|3.921||0.3463|TWO_SIDED|95.0|-11.39|4.002|||ANCOVA|||Week 1: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 1 as an interaction term, baseline Physician's Global Assessment of Arthritis count as the covariate and participant as a random effect.||4.002|-11.39|0.3463
72494190|NCT04418765|144517313|OTHER|Testing sequence: 1. Change in MMDs (Weeks 1-12) 300 mg vs placebo; 2. 50% responders for MMDs (Weeks 1-12) 300 mg vs placebo; 3. Change in MMDs (Weeks 1-12) 100 mg vs placebo; 4. 50% responders for MMDs (Weeks 1-12) 100 mg vs placebo; 5a. Change in MMDs (Weeks 13-24), 5b. 75% responders for MMDs (Weeks 1-12), 5c. Change in HIT-6 (Week 12) 300 mg vs placebo; 6a. Change in MMDs (Weeks 13-24), 6b. 75% responders for MMDs (Weeks 1-12), 6c. Change in HIT-6 (Week 12) 100 mg vs placebo.|Mean Difference (Final Values)|-2.7|STANDARD_ERROR_OF_MEAN|0.36|<|0.0001|TWO_SIDED|95.0|-3.4|-2.0||Testing continued only, if the previous comparison was statistically significant. Threshold for significance: p-value \<α, where α = 0.05. Here it is test no. 3 of testing order.|Mixed Models Analysis|||"Analysis was performed using an REML-based MMRM with month (Weeks 1-4, Weeks 5-8, Weeks 9-12, Weeks 13-16, Weeks 17-20, Weeks 21-24), country, stratification factor (monthly MHDs at baseline: ≤14/\>14) and treatment as factors, baseline score as a continuous covariate, treatment-by-month interaction, baseline score-by-month interaction, and stratum-by-month interaction.~A testing strategy (sequence of tests) was applied to ensure protection of the type 1 error."||-2.0|-3.4|<0.0001
72494191|NCT04418765|144517314|OTHER|Testing sequence: 1. Change in MMDs (Weeks 1-12) 300 mg vs placebo; 2. 50% responders for MMDs (Weeks 1-12) 300 mg vs placebo; 3. Change in MMDs (Weeks 1-12) 100 mg vs placebo; 4. 50% responders for MMDs (Weeks 1-12) 100 mg vs placebo; 5a. Change in MMDs (Weeks 13-24), 5b. 75% responders for MMDs (Weeks 1-12), 5c. Change in HIT-6 (Week 12) 300 mg vs placebo; 6a. Change in MMDs (Weeks 13-24), 6b. 75% responders for MMDs (Weeks 1-12), 6c. Change in HIT-6 (Week 12) 100 mg vs placebo.|Odds Ratio (OR)|6.58|||<|0.0001|TWO_SIDED|95.0|4.41|10.01||Testing continued only, if the previous comparison was statistically significant. Threshold for significance: p-value \<α, where α = 0.05. Here it is test no. 2 of testing order.|Regression, Logistic|||"Analysis was performed using logistic regression model including baseline MMDs as a continuous covariate, and treatment and stratification factor (MHD at baseline: ≤14/\>14) as factors.~A testing strategy (sequence of tests) was applied to ensure protection of the type 1 error."||10.01|4.41|<0.0001
72494192|NCT04418765|144517314|OTHER|Testing sequence: 1. Change in MMDs (Weeks 1-12) 300 mg vs placebo; 2. 50% responders for MMDs (Weeks 1-12) 300 mg vs placebo; 3. Change in MMDs (Weeks 1-12) 100 mg vs placebo; 4. 50% responders for MMDs (Weeks 1-12) 100 mg vs placebo; 5a. Change in MMDs (Weeks 13-24), 5b. 75% responders for MMDs (Weeks 1-12), 5c. Change in HIT-6 (Week 12) 300 mg vs placebo; 6a. Change in MMDs (Weeks 13-24), 6b. 75% responders for MMDs (Weeks 1-12), 6c. Change in HIT-6 (Week 12) 100 mg vs placebo.|Odds Ratio (OR)|4.91|||<|0.0001|TWO_SIDED|95.0|3.29|7.47||Testing continued only, if the previous comparison was statistically significant. Threshold for significance: p-value \<α, where α = 0.05. Here it is test no. 4 of testing order.|Regression, Logistic|||"Analysis was performed using logistic regression model including baseline MMDs as a continuous covariate, and treatment and stratification factor (MHD at baseline: ≤14/\>14) as factors.~A testing strategy (sequence of tests) was applied to ensure protection of the type 1 error."||7.47|3.29|<0.0001
72494193|NCT04418765|144517315|OTHER|Testing sequence: 1. Change in MMDs (Weeks 1-12) 300 mg vs placebo; 2. 50% responders for MMDs (Weeks 1-12) 300 mg vs placebo; 3. Change in MMDs (Weeks 1-12) 100 mg vs placebo; 4. 50% responders for MMDs (Weeks 1-12) 100 mg vs placebo; 5a. Change in MMDs (Weeks 13-24), 5b. 75% responders for MMDs (Weeks 1-12), 5c. Change in HIT-6 (Week 12) 300 mg vs placebo; 6a. Change in MMDs (Weeks 13-24), 6b. 75% responders for MMDs (Weeks 1-12), 6c. Change in HIT-6 (Week 12) 100 mg vs placebo.|Mean Difference (Final Values)|-3.7|STANDARD_ERROR_OF_MEAN|0.39|<|0.0001|TWO_SIDED|95.0|-4.5|-3.0||Threshold for significance: p-value \<α, where α = 0.05. Here it is test no. 5a of testing order.|Mixed Models Analysis|Testing continued only, if the previous comparison was statistically significant.||"Analysis was performed using an REML-based MMRM with month (Weeks 1-4, Weeks 5-8, Weeks 9-12, Weeks 13-16, Weeks 17-20, Weeks 21-24), country, stratification factor (monthly MHDs at baseline: ≤14/\>14) and treatment as factors, baseline score as a continuous covariate, treatment-by-month interaction, baseline score-by-month interaction, and stratum-by-month interaction.~A testing strategy (sequence of tests) was applied to ensure protection of the type 1 error."||-3.0|-4.5|<0.0001
72618719|NCT01026038|144768109|SUPERIORITY_OR_OTHER||GMT Ratio|1.0|||||TWO_SIDED|95.0|0.76|1.3||||||Serotype 4: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.30|0.76|
72504541|NCT00923091|144539810|SUPERIORITY_OR_OTHER|||||||0.0107||95.0|||||ANCOVA|||||||0.0107
72504542|NCT00923091|144539811|SUPERIORITY_OR_OTHER|||||||0.0006||95.0|||||ANCOVA|||||||0.0006
72504543|NCT00923091|144539811|SUPERIORITY_OR_OTHER|||||||0.0008||95.0|||||ANCOVA|||||||0.0008
72504544|NCT00923091|144539811|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||||||<0.0001
72504545|NCT00923091|144539811|SUPERIORITY_OR_OTHER|||||||0.0034||95.0|||||ANCOVA|||||||0.0034
72504546|NCT00923091|144539811|SUPERIORITY_OR_OTHER|||||||0.0006||95.0|||||ANCOVA|||||||0.0006
72504547|NCT00923091|144539812|SUPERIORITY_OR_OTHER|||||||0.0295||95.0|||||Cochran-Mantel-Haenszel|||||||0.0295
72504548|NCT00923091|144539812|SUPERIORITY_OR_OTHER|||||||0.2529||95.0|||||Cochran-Mantel-Haenszel|||||||0.2529
72618720|NCT01026038|144768109|SUPERIORITY_OR_OTHER||GMT Ratio|0.9|||||TWO_SIDED|95.0|0.69|1.3||||||Serotype 4: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.30|0.69|
72504549|NCT00923091|144539812|SUPERIORITY_OR_OTHER|||||||0.0037||95.0|||||Cochran-Mantel-Haenszel|||||||0.0037
72504550|NCT00923091|144539812|SUPERIORITY_OR_OTHER|||||||0.2033||95.0|||||Cochran-Mantel-Haenszel|||||||0.2033
72435020|NCT00383188|144383170|SUPERIORITY||LSM Difference|-5.185|STANDARD_ERROR_OF_MEAN|3.312||0.1178|TWO_SIDED|95.0|-11.69|1.316|||ANCOVA|||Week 2: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 2 as an interaction term, baseline Physician's Global Assessment of Arthritis count as the covariate and participant as a random effect.||1.316|-11.69|0.1178
72435021|NCT00383188|144383170|SUPERIORITY||LSM Difference|-7.107|STANDARD_ERROR_OF_MEAN|3.245||0.0288|TWO_SIDED|95.0|-13.48|-0.737|||ANCOVA|||Week 2: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 2 as an interaction term, baseline Physician's Global Assessment of Arthritis count as the covariate and participant as a random effect.||-0.737|-13.48|0.0288
72435022|NCT00383188|144383170|SUPERIORITY||LSM Difference|-9.743|STANDARD_ERROR_OF_MEAN|3.772||0.01|TWO_SIDED|95.0|-17.15|-2.34|||ANCOVA|||Week 2: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 2 as an interaction term, baseline Physician's Global Assessment of Arthritis count as the covariate and participant as a random effect.||-2.340|-17.15|0.0100
72435023|NCT00383188|144383170|SUPERIORITY||LSM Difference|-5.468|STANDARD_ERROR_OF_MEAN|3.888||0.16|TWO_SIDED|95.0|-13.1|2.164|||ANCOVA|||Week 2: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 2 as an interaction term, baseline Physician's Global Assessment of Arthritis count as the covariate and participant as a random effect.||2.164|-13.10|0.1600
72435024|NCT00383188|144383170|SUPERIORITY||LSM Difference|-0.4|STANDARD_ERROR_OF_MEAN|3.312||0.904|TWO_SIDED|95.0|-6.9|6.101|||ANCOVA|||Week 4: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 4 as an interaction term, baseline Physician's Global Assessment of Arthritis count as the covariate and participant as a random effect.||6.101|-6.900|0.9040
72435025|NCT00383188|144383170|SUPERIORITY||LSM Difference|-6.895|STANDARD_ERROR_OF_MEAN|3.245||0.0339|TWO_SIDED|95.0|-13.26|-0.524|||ANCOVA|||Week 4: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 4 as an interaction term, baseline Physician's Global Assessment of Arthritis count as the covariate and participant as a random effect.||-0.524|-13.26|0.0339
72435026|NCT00383188|144383170|SUPERIORITY||LSM Difference|-8.891|STANDARD_ERROR_OF_MEAN|3.771||0.0186|TWO_SIDED|95.0|-16.29|-1.488|||ANCOVA|||Week 4: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 4 as an interaction term, baseline Physician's Global Assessment of Arthritis count as the covariate and participant as a random effect.||-1.488|-16.29|0.0186
72435027|NCT00383188|144383170|SUPERIORITY||LSM Difference|-2.714|STANDARD_ERROR_OF_MEAN|3.888||0.4854|TWO_SIDED|95.0|-10.35|4.918|||ANCOVA|||Week 4: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 4 as an interaction term, baseline Physician's Global Assessment of Arthritis count as the covariate and participant as a random effect.||4.918|-10.35|0.4854
72435028|NCT00383188|144383170|SUPERIORITY||LSM Difference|-1.387|STANDARD_ERROR_OF_MEAN|3.311||0.6753|TWO_SIDED|95.0|-7.886|5.112|||ANCOVA|||Week 8: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 8 as an interaction term, baseline Physician's Global Assessment of Arthritis count as the covariate and participant as a random effect.||5.112|-7.886|0.6753
72435029|NCT00383188|144383170|SUPERIORITY||LSM Difference|-11.09|STANDARD_ERROR_OF_MEAN|3.244||0.0007|TWO_SIDED|95.0|-17.46|-4.724|||ANCOVA|||Week 8: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 8 as an interaction term, baseline Physician's Global Assessment of Arthritis count as the covariate and participant as a random effect.||-4.724|-17.46|0.0007
72435030|NCT00383188|144383170|SUPERIORITY||LSM Difference|-9.535|STANDARD_ERROR_OF_MEAN|3.771||0.0116|TWO_SIDED|95.0|-16.94|-2.134|||ANCOVA|||Week 8: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 8 as an interaction term, baseline Physician's Global Assessment of Arthritis count as the covariate and participant as a random effect.||-2.134|-16.94|0.0116
72435031|NCT00383188|144383170|SUPERIORITY||LSM Difference|-8.322|STANDARD_ERROR_OF_MEAN|3.888||0.0326|TWO_SIDED|95.0|-15.95|-0.691|||ANCOVA|||Week 8: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 8 as an interaction term, baseline Physician's Global Assessment of Arthritis count as the covariate and participant as a random effect.||-0.691|-15.95|0.0326
72435032|NCT00383188|144383170|SUPERIORITY||LSM Difference|-3.624|STANDARD_ERROR_OF_MEAN|3.309||0.2738|TWO_SIDED|95.0|-10.12|2.872|||ANCOVA|||Week 12: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 12 as an interaction term, baseline Physician's Global Assessment of Arthritis count as the covariate and participant as a random effect.||2.872|-10.12|0.2738
72435033|NCT00383188|144383170|SUPERIORITY||LSM Difference|-9.778|STANDARD_ERROR_OF_MEAN|3.243||0.0026|TWO_SIDED|95.0|-16.14|-3.412|||ANCOVA|||Week 12: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 12 as an interaction term, baseline Physician's Global Assessment of Arthritis count as the covariate and participant as a random effect.||-3.412|-16.14|0.0026
72435034|NCT00383188|144383170|SUPERIORITY||LSM Difference|-9.339|STANDARD_ERROR_OF_MEAN|3.769||0.0134|TWO_SIDED|95.0|-16.74|-1.941|||ANCOVA|||Week 12: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 12 as an interaction term, baseline Physician's Global Assessment of Arthritis count as the covariate and participant as a random effect.||-1.941|-16.74|0.0134
72504551|NCT00923091|144539812|SUPERIORITY_OR_OTHER|||||||0.2529||95.0|||||Cochran-Mantel-Haenszel|||||||0.2529
72504552|NCT00923091|144539813|SUPERIORITY_OR_OTHER|||||||0.1135||95.0|||||ANCOVA|||||||0.1135
72504553|NCT00923091|144539814|SUPERIORITY_OR_OTHER|||||||0.2765||95.0|||||ANCOVA|||||||0.2765
72504554|NCT00923091|144539815|SUPERIORITY_OR_OTHER|||||||0.4964||95.0|||||Cochran-Mantel-Haenszel|||||||0.4964
72504555|NCT00923091|144539816|SUPERIORITY_OR_OTHER|||||||0.1301||95.0|||||ANCOVA|||||||0.1301
72504556|NCT00923091|144539816|SUPERIORITY_OR_OTHER|||||||0.01301||95.0|||||ANCOVA|||||||0.01301
72504557|NCT00923091|144539817|SUPERIORITY_OR_OTHER|||||||0.0503||95.0|||||ANCOVA|||||||0.0503
72504558|NCT00467649|144539828|SUPERIORITY_OR_OTHER|||||||0.018||95.0|||||Fisher Exact|||||||0.0180
72435035|NCT00383188|144383170|SUPERIORITY||LSM Difference|-5.528|STANDARD_ERROR_OF_MEAN|3.886||0.1553|TWO_SIDED|95.0|-13.16|2.101|||ANCOVA|||Week 12: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 12 as an interaction term, baseline Physician's Global Assessment of Arthritis count as the covariate and participant as a random effect.||2.101|-13.16|0.1553
72435036|NCT00383188|144383170|SUPERIORITY||LSM Difference|-0.118|STANDARD_ERROR_OF_MEAN|3.444||0.9726|TWO_SIDED|95.0|-6.878|6.641|||ANCOVA|||Week 16: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 16 as an interaction term, baseline Physician's Global Assessment of Arthritis count as the covariate and participant as a random effect.||6.641|-6.878|0.9726
72435037|NCT00383188|144383170|SUPERIORITY||LSM Difference|1.409|STANDARD_ERROR_OF_MEAN|3.321||0.6714|TWO_SIDED|95.0|-5.109|7.928|||ANCOVA|||Week 16: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 16 as an interaction term, baseline Physician's Global Assessment of Arthritis count as the covariate and participant as a random effect.||7.928|-5.109|0.6714
72435038|NCT00383188|144383170|SUPERIORITY||LSM Difference|0.646|STANDARD_ERROR_OF_MEAN|3.925||0.8693|TWO_SIDED|95.0|-7.058|8.351|||ANCOVA|||Week 16: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 16 as an interaction term, baseline Physician's Global Assessment of Arthritis count as the covariate and participant as a random effect.||8.351|-7.058|0.8693
72435039|NCT00383188|144383170|SUPERIORITY||LSM Difference|1.289|STANDARD_ERROR_OF_MEAN|4.035||0.7495|TWO_SIDED|95.0|-6.631|9.208|||ANCOVA|||Week 16: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 16 as an interaction term, baseline Physician's Global Assessment of Arthritis count as the covariate and participant as a random effect.||9.208|-6.631|0.7495
72435040|NCT00383188|144383171|SUPERIORITY||LSM Difference|-8.983|STANDARD_ERROR_OF_MEAN|4.469||0.0447|TWO_SIDED|95.0|-17.75|-0.214|||ANCOVA|||Week 1: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 1 as an interaction term, baseline C-Reactive Protein as the covariate and participant as a random effect.||-0.214|-17.75|0.0447
72435041|NCT00383188|144383171|SUPERIORITY||LSM Difference|-15.12|STANDARD_ERROR_OF_MEAN|4.345||0.0005|TWO_SIDED|95.0|-23.65|-6.596|||ANCOVA|||Week 1: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 1 as an interaction term, baseline C-Reactive Protein as the covariate and participant as a random effect.||-6.596|-23.65|0.0005
72435042|NCT00383188|144383171|SUPERIORITY||LSM Difference|-17.07|STANDARD_ERROR_OF_MEAN|4.981||0.0006|TWO_SIDED|95.0|-26.84|-7.296|||ANCOVA|||Week 1: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 1 as an interaction term, baseline C-Reactive Protein as the covariate and participant as a random effect.||-7.296|-26.84|0.0006
72435043|NCT00383188|144383171|SUPERIORITY||LSM Difference|-16.26|STANDARD_ERROR_OF_MEAN|5.218||0.0019|TWO_SIDED|95.0|-26.49|-6.018|||ANCOVA|||Week 1: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 1 as an interaction term, baseline C-Reactive Protein as the covariate and participant as a random effect.||-6.018|-26.49|0.0019
72435044|NCT00383188|144383171|SUPERIORITY||LSM Difference|-3.841|STANDARD_ERROR_OF_MEAN|4.366||0.3792|TWO_SIDED|95.0|-12.41|4.726|||ANCOVA|||Week 2: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 2 as an interaction term, baseline C-Reactive Protein as the covariate and participant as a random effect.||4.726|-12.41|0.3792
72435045|NCT00383188|144383171|SUPERIORITY||LSM Difference|-9.345|STANDARD_ERROR_OF_MEAN|4.237||0.0276|TWO_SIDED|95.0|-17.66|-1.031|||ANCOVA|||Week 2: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 2 as an interaction term, baseline C-Reactive Protein as the covariate and participant as a random effect.||-1.031|-17.66|0.0276
72435046|NCT00383188|144383171|SUPERIORITY||LSM Difference|-12.69|STANDARD_ERROR_OF_MEAN|4.873||0.0093|TWO_SIDED|95.0|-22.25|-3.128|||ANCOVA|||Week 2: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 2 as an interaction term, baseline C-Reactive Protein as the covariate and participant as a random effect.||-3.128|-22.25|0.0093
72435047|NCT00383188|144383171|SUPERIORITY||LSM Difference|-9.599|STANDARD_ERROR_OF_MEAN|5.03||0.0566|TWO_SIDED|95.0|-19.47|0.271|||ANCOVA|||Week 2: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 2 as an interaction term, baseline C-Reactive Protein as the covariate and participant as a random effect.||0.271|-19.47|0.0566
72435048|NCT00383188|144383171|SUPERIORITY||LSM Difference|0.803|STANDARD_ERROR_OF_MEAN|4.366||0.854|TWO_SIDED|95.0|-7.764|9.37|||ANCOVA|||Week 4: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 4 as an interaction term, baseline C-Reactive Protein as the covariate and participant as a random effect.||9.370|-7.764|0.8540
72435049|NCT00383188|144383171|SUPERIORITY||LSM Difference|-2.364|STANDARD_ERROR_OF_MEAN|4.237||0.577|TWO_SIDED|95.0|-10.68|5.95|||ANCOVA|||Week 4: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 4 as an interaction term, baseline C-Reactive Protein as the covariate and participant as a random effect.||5.950|-10.68|0.5770
72435050|NCT00383188|144383171|SUPERIORITY||LSM Difference|-6.33|STANDARD_ERROR_OF_MEAN|4.873||0.1942|TWO_SIDED|95.0|-15.89|3.232|||ANCOVA|||Week 4: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 4 as an interaction term, baseline C-Reactive Protein as the covariate and participant as a random effect.||3.232|-15.89|0.1942
72435051|NCT00383188|144383171|SUPERIORITY||LSM Difference|1.494|STANDARD_ERROR_OF_MEAN|5.03||0.7665|TWO_SIDED|95.0|-8.376|11.364|||ANCOVA|||Week 4: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 4 as an interaction term, baseline C-Reactive Protein as the covariate and participant as a random effect.||11.364|-8.376|0.7665
72504559|NCT01852344|144539854|SUPERIORITY|||||||0.159|||||||t-test, 2 sided|||||||0.159
72504560|NCT01852344|144539854|SUPERIORITY|||||||0.159|||||||t-test, 2 sided|||||||0.159
72504561|NCT01852344|144539855|SUPERIORITY|||||||0.236|||||||t-test, 2 sided|||||||0.236
72494194|NCT04418765|144517315|OTHER|Testing sequence: 1. Change in MMDs (Weeks 1-12) 300 mg vs placebo; 2. 50% responders for MMDs (Weeks 1-12) 300 mg vs placebo; 3. Change in MMDs (Weeks 1-12) 100 mg vs placebo; 4. 50% responders for MMDs (Weeks 1-12) 100 mg vs placebo; 5a. Change in MMDs (Weeks 13-24), 5b. 75% responders for MMDs (Weeks 1-12), 5c. Change in HIT-6 (Week 12) 300 mg vs placebo; 6a. Change in MMDs (Weeks 13-24), 6b. 75% responders for MMDs (Weeks 1-12), 6c. Change in HIT-6 (Week 12) 100 mg vs placebo.|Mean Difference (Final Values)|-3.0|STANDARD_ERROR_OF_MEAN|0.39|<|0.0001|TWO_SIDED|95.0|-3.8|-2.2||Threshold for significance: The consecutive order of the smallest (p1), the second smallest (p2), and the largest p-value (p3) had to be \<α/3, \<α/2, and \<α, where α = 0.05. Here it is test no. 6a of testing order.|Mixed Models Analysis|Testing continued only, if the previous comparison was statistically significant.||"Analysis was performed using an REML-based MMRM with month (Weeks 1-4, Weeks 5-8, Weeks 9-12, Weeks 13-16, Weeks 17-20, Weeks 21-24), country, stratification factor (monthly MHDs at baseline: ≤14/\>14) and treatment as factors, baseline score as a continuous covariate, treatment-by-month interaction, baseline score-by-month interaction, and stratum-by-month interaction.~A testing strategy (sequence of tests) was applied to ensure protection of the type 1 error."||-2.2|-3.8|<0.0001
72435052|NCT00383188|144383171|SUPERIORITY||LSM Difference|3.291|STANDARD_ERROR_OF_MEAN|4.366||0.4512|TWO_SIDED|95.0|-5.276|11.858|||ANCOVA|||Week 8: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 8 as an interaction term, baseline C-Reactive Protein as the covariate and participant as a random effect.||11.858|-5.276|0.4512
72435053|NCT00383188|144383171|SUPERIORITY||LSM Difference|-0.095|STANDARD_ERROR_OF_MEAN|4.237||0.9822|TWO_SIDED|95.0|-8.409|8.22|||ANCOVA|||Week 8: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 8 as an interaction term, baseline C-Reactive Protein as the covariate and participant as a random effect.||8.220|-8.409|0.9822
72435054|NCT00383188|144383171|SUPERIORITY||LSM Difference|-5.148|STANDARD_ERROR_OF_MEAN|4.873||0.291|TWO_SIDED|95.0|-14.71|4.414|||ANCOVA|||Week 8: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 8 as an interaction term, baseline C-Reactive Protein as the covariate and participant as a random effect.||4.414|-14.71|0.2910
72435055|NCT00383188|144383171|SUPERIORITY||LSM Difference|2.828|STANDARD_ERROR_OF_MEAN|5.03||0.5741|TWO_SIDED|95.0|-7.042|12.698|||ANCOVA|||Week 8: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 8 as an interaction term, baseline C-Reactive Protein as the covariate and participant as a random effect.||12.698|-7.042|0.5741
72435056|NCT00383188|144383171|SUPERIORITY||LSM Difference|3.107|STANDARD_ERROR_OF_MEAN|4.366||0.4768|TWO_SIDED|95.0|-5.46|11.674|||ANCOVA|||Week 12: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 12 as an interaction term, baseline C-Reactive Protein as the covariate and participant as a random effect.||11.674|-5.460|0.4768
72435057|NCT00383188|144383171|SUPERIORITY||LSM Difference|-2.256|STANDARD_ERROR_OF_MEAN|4.237||0.5945|TWO_SIDED|95.0|-10.57|6.058|||ANCOVA|||Week 12: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 12 as an interaction term, baseline C-Reactive Protein as the covariate and participant as a random effect.||6.058|-10.57|0.5945
72435058|NCT00383188|144383171|SUPERIORITY||LSM Difference|0.609|STANDARD_ERROR_OF_MEAN|4.873||0.9006|TWO_SIDED|95.0|-8.953|10.171|||ANCOVA|||Week 12: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 12 as an interaction term, baseline C-Reactive Protein as the covariate and participant as a random effect.||10.171|-8.953|0.9006
72435059|NCT00383188|144383171|SUPERIORITY||LSM Difference|9.224|STANDARD_ERROR_OF_MEAN|5.03||0.067|TWO_SIDED|95.0|-0.646|19.094|||ANCOVA|||Week 12: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 12 as an interaction term, baseline C-Reactive Protein as the covariate and participant as a random effect.||19.094|-0.646|0.0670
72494195|NCT04418765|144517316|OTHER|Testing sequence: 1. Change in MMDs (Weeks 1-12) 300 mg vs placebo; 2. 50% responders for MMDs (Weeks 1-12) 300 mg vs placebo; 3. Change in MMDs (Weeks 1-12) 100 mg vs placebo; 4. 50% responders for MMDs (Weeks 1-12) 100 mg vs placebo; 5a. Change in MMDs (Weeks 13-24), 5b. 75% responders for MMDs (Weeks 1-12), 5c. Change in HIT-6 (Week 12) 300 mg vs placebo; 6a. Change in MMDs (Weeks 13-24), 6b. 75% responders for MMDs (Weeks 1-12), 6c. Change in HIT-6 (Week 12) 100 mg vs placebo.|Odds Ratio (OR)|11.43|||<|0.0001|TWO_SIDED|95.0|5.22|30.15||Threshold for significance: The consecutive order of the smallest (p1), the second smallest (p2), and the largest p-value (p3) had to be \<α/3, \<α/2, and \<α, where α = 0.05. Here it is test no. 5b of testing order.|Regression, Logistic|||"Analysis was performed using logistic regression model including baseline MMDs as a continuous covariate, and treatment and stratification factor (MHD at baseline: ≤14/\>14) as factors.~A testing strategy (sequence of tests) was applied to ensure protection of the type 1 error.~Testing continued only, if the previous comparison was statistically significant."||30.15|5.22|<0.0001
72494196|NCT04418765|144517316|OTHER|Testing sequence: 1. Change in MMDs (Weeks 1-12) 300 mg vs placebo; 2. 50% responders for MMDs (Weeks 1-12) 300 mg vs placebo; 3. Change in MMDs (Weeks 1-12) 100 mg vs placebo; 4. 50% responders for MMDs (Weeks 1-12) 100 mg vs placebo; 5a. Change in MMDs (Weeks 13-24), 5b. 75% responders for MMDs (Weeks 1-12), 5c. Change in HIT-6 (Week 12) 300 mg vs placebo; 6a. Change in MMDs (Weeks 13-24), 6b. 75% responders for MMDs (Weeks 1-12), 6c. Change in HIT-6 (Week 12) 100 mg vs placebo.|Odds Ratio (OR)|9.19|||<|0.0001|TWO_SIDED|95.0|4.16|24.35||Threshold for significance: The consecutive order of the smallest (p1), the second smallest (p2), and the largest p-value (p3) had to be \<α/3, \<α/2, and \<α, where α = 0.05. Here it is test no. 6b of testing order.|Regression, Logistic|||"Analysis was performed using logistic regression model including baseline MMDs as a continuous covariate, and treatment and stratification factor (MHD at baseline: ≤14/\>14) as factors.~A testing strategy (sequence of tests) was applied to ensure protection of the type 1 error.~Testing continued only, if the previous comparison was statistically significant."||24.35|4.16|<0.0001
72504562|NCT01852344|144539856|SUPERIORITY|||||||0.032|||||||t-test, 2 sided|||||||0.032
72504563|NCT04458857|144539896|OTHER||LS mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.44||0.021|TWO_SIDED|95.0|-1.9|-0.16|||ANCOVA|||||-0.16|-1.90|0.0210
72435060|NCT00383188|144383171|SUPERIORITY||LSM Difference|8.261|STANDARD_ERROR_OF_MEAN|4.647||0.0757|TWO_SIDED|95.0|-0.857|17.379|||ANCOVA|||Week 16: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 16 as an interaction term, baseline C-Reactive Protein as the covariate and participant as a random effect.||17.379|-0.857|0.0757
72383001|NCT05595382|144274480|SUPERIORITY|Repeated measures of likelihood to enroll (on a 1 to 7 scale with higher numbers indicating a greater likelihood) pre/post intervention||||||0.001|||||||ANOVA|Degrees of freedom (1, 359)||||||.001
72383002|NCT05595382|144274481|SUPERIORITY|||||||0.357|||||||ANOVA|Degrees of freedom (1, 358)||Repeated measures ANOVA comparing mood (rated on a 1-10 scale with higher scores indicating better mood) given to participants before and after the study manipulation by group||||.357
72383003|NCT05595382|144274482|SUPERIORITY|||||||0.102|||||||ANOVA|||||||.102
72383004|NCT02445391|144274491|NON_INFERIORITY|The null hypothesis for testing non-inferiority of platinum was defined as that the hazard ratio (HR) for platinum/capecitabine ≥ 1.154 (ie, HR of 1.154 was used as the non-inferiority margin). The alternative hypothesis was HR=0.754 for platinum/ capecitabine. The 4-year IDFS rate was expected to be 67% on capecitabine arm.|Hazard Ratio (HR)|1.06|||||TWO_SIDED|95.0|0.62|1.81|||||The 95% confidence interval provided above was the Jennison and Turnbull repeated confidence interval.|||1.81|0.62|
72383005|NCT03722173|144274497|OTHER|Since the main focus was on estimation and not testing, a formal hypothesis test and associated acceptance range was not specified; no hypothesis was tested.|gMeans ratio (T/R) %|141.62|STANDARD_ERROR_OF_MEAN|13.3|||TWO_SIDED|90.0|129.64|154.71|||ANOVA|Analysis of variance (ANOVA) model on the logarithmic scale including effects for 'subjects' and 'treatment' was used.|Standard error of the mean is actually an intra-individual coefficient variation (CV). Confidence intervals (CIs) were calculated based on the residual error from the ANOVA and quantiles from the t distribution.|Point estimates for the ratios of the geometric means (gMeans) (T/R) for AUC0-tz and their 2-sided 90% confidence intervals (CIs) were provided. The difference between the expected means for log(T) - log(R) were estimated by the difference in the corresponding adjusted means (Least Squares Means).||154.71|129.64|
72383006|NCT03722173|144274498|OTHER|Since the main focus was on estimation and not testing, a formal hypothesis test and associated acceptance range was not specified; no hypothesis was tested.|gMeans ratio (T/R) %|113.32|STANDARD_ERROR_OF_MEAN|15.1|||TWO_SIDED|90.0|102.47|125.32|||ANOVA|Analysis of variance (ANOVA) model on the logarithmic scale including effects for 'subjects' and 'treatment' was used.|Standard error of the mean is actually an intra-individual coefficient variation (CV). Confidence intervals (CIs) were calculated based on the residual error from the ANOVA and quantiles from the t distribution.|Point estimates for the ratios of the gMeans (T/R) for Cmax and their 2-sided 90% CIs were provided. The difference between the expected means for log(T) - log(R) were estimated by the difference in the corresponding adjusted means (Least Squares Means).||125.32|102.47|
72383007|NCT03722173|144274499|OTHER|Since the main focus was on estimation and not testing, a formal hypothesis test and associated acceptance range was not specified; no hypothesis was tested.|gMeans ratio (T/R) %|142.54|STANDARD_ERROR_OF_MEAN|13.5|||TWO_SIDED|90.0|130.3|155.93|||ANOVA|Analysis of variance (ANOVA) model on the logarithmic scale including effects for 'subjects' and 'treatment' was used.|Standard error of the mean is actually an intra-individual coefficient variation (CV). Confidence intervals (CIs) were calculated based on the residual error from the ANOVA and quantiles from the t distribution.|Point estimates for the ratios of the gMeans (T/R) for AUC0-∞ and their 2-sided 90% CIs were provided. The difference between the expected means for log(T) - log(R) were estimated by the difference in the corresponding adjusted means (Least Squares Means).||155.93|130.30|
72435061|NCT00383188|144383171|SUPERIORITY||LSM Difference|5.357|STANDARD_ERROR_OF_MEAN|4.427||0.2265|TWO_SIDED|95.0|-3.329|14.043|||ANCOVA|||Week 16: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 16 as an interaction term, baseline C-Reactive Protein as the covariate and participant as a random effect.||14.043|-3.329|0.2265
72435062|NCT00383188|144383171|SUPERIORITY||LSM Difference|1.642|STANDARD_ERROR_OF_MEAN|5.178||0.7512|TWO_SIDED|95.0|-8.517|11.801|||ANCOVA|||Week 16: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 16 as an interaction term, baseline C-Reactive Protein as the covariate and participant as a random effect.||11.801|-8.517|0.7512
72435063|NCT00383188|144383171|SUPERIORITY||LSM Difference|2.888|STANDARD_ERROR_OF_MEAN|5.323||0.5876|TWO_SIDED|95.0|-7.557|13.332|||ANCOVA|||Week 16: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 16 as an interaction term, baseline C-Reactive Protein as the covariate and participant as a random effect.||13.332|-7.557|0.5876
72435064|NCT00383188|144383172|SUPERIORITY||LSM Difference|-0.269|STANDARD_ERROR_OF_MEAN|0.188||0.154|TWO_SIDED|95.0|-0.638|0.101|||ANCOVA|||Week 1: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 1 as an interaction term, baseline DAS28-4(CRP) as the covariate; and participant as a random effect.||0.101|-0.638|0.1540
72435065|NCT00383188|144383172|SUPERIORITY||LSM Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.182||0.0011|TWO_SIDED|95.0|-0.958|-0.242|||ANCOVA|||Week 1: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 1 as an interaction term, baseline DAS28-4(CRP) as the covariate; and participant as a random effect.||-0.242|-0.958|0.0011
72435066|NCT00383188|144383172|SUPERIORITY||LSM Difference|-0.691|STANDARD_ERROR_OF_MEAN|0.211||0.0011|TWO_SIDED|95.0|-1.105|-0.277|||ANCOVA|||Week 1: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 1 as an interaction term, baseline DAS28-4(CRP) as the covariate; and participant as a random effect.||-0.277|-1.105|0.0011
72557920|NCT00205777|144645461|SUPERIORITY_OR_OTHER|||||||0.13||95.0|||||ANOVA|||||||0.13
72383008|NCT01828320|144274514|SUPERIORITY||d (effect size)|-0.08||||0.34|TWO_SIDED||||||Intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||||||0.34
72383009|NCT01828320|144274515|SUPERIORITY||d (effect size)|-0.06||||0.93|TWO_SIDED||||||intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||||||0.93
72557921|NCT00205777|144645461|SUPERIORITY_OR_OTHER|||||||0.11||95.0|||||ANOVA|||||||0.11
72383010|NCT01828320|144274516|SUPERIORITY||d (effect size)|-0.5||||0.01|TWO_SIDED|||||Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random was used to examine continuous outcomes.|Intent-to-treat, multilevel modeling|||||||0.01
72383011|NCT01828320|144274517|SUPERIORITY||d (effect size)|0.18||||0.17|TWO_SIDED|||||Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random was used to examine continuous outcomes.|Intent-to-treat, multilevel modeling|||||||0.17
72383012|NCT01828320|144274518|SUPERIORITY||d (effect size)|0.07||||0.31|TWO_SIDED|||||Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random was used to examine continuous outcomes.|Intent-to-treat, multilevel modeling|||||||0.31
72383013|NCT01828320|144274519|SUPERIORITY||d (effect size)|0.001||||0.8|TWO_SIDED|||||Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random was used to examine continuous outcomes.|Intent-to-treat, multilevel modeling|||||||0.80
72383014|NCT01828320|144274520|SUPERIORITY||d (effect size)|0.04||||0.96|TWO_SIDED|||||Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random was used to examine continuous outcomes.|Intent-to-treat, multilevel modeling|||||||0.96
72383015|NCT01828320|144274521|SUPERIORITY||d (effect size)|-0.05||||0.83|TWO_SIDED|||||Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random was used to examine continuous outcomes.|intent-to-treat, multilevel modeling|||||||0.83
72383016|NCT01828320|144274522|SUPERIORITY||d (effect size)|0.35||||0.02|TWO_SIDED|||||Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random was used to examine continuous outcomes.|Intent-to-treat, multilevel modeling|||||||0.02
72383017|NCT01828320|144274523|SUPERIORITY||d (effect size)|0.28||||0.04|TWO_SIDED|||||Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random was used to examine continuous outcomes.|Intent-to-treat, multilevel modeling|||||||0.04
72383018|NCT01828320|144274524|SUPERIORITY||d (effect size)|0.29||||0.04|TWO_SIDED|||||Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random was used to examine continuous outcomes.|Intent-to-treat, multilevel modeling|||||||0.04
72383019|NCT01828320|144274525|SUPERIORITY||d (effect size)|-0.44||||0.03|TWO_SIDED||||||Intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||||||0.03
72383020|NCT01828320|144274526|SUPERIORITY||d (effect size)|0.07||||0.71|TWO_SIDED|||||Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random was used to examine continuous outcomes.|intent-to-treat, multilevel modeling|||||||0.71
72435067|NCT00383188|144383172|SUPERIORITY||LSM Difference|-0.554|STANDARD_ERROR_OF_MEAN|0.219||0.0115|TWO_SIDED|95.0|-0.983|-0.125|||ANCOVA|||Week 1: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 1 as an interaction term, baseline DAS28-4(CRP) as the covariate; and participant as a random effect.||-0.125|-0.983|0.0115
72435068|NCT00383188|144383172|SUPERIORITY||LSM Difference|-0.31|STANDARD_ERROR_OF_MEAN|0.185||0.094|TWO_SIDED|95.0|-0.673|0.053|||ANCOVA|||Week 2: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 2 as an interaction term, baseline DAS28-4(CRP) as the covariate; and participant as a random effect.||0.053|-0.673|0.0940
72435069|NCT00383188|144383172|SUPERIORITY||LSM Difference|-0.459|STANDARD_ERROR_OF_MEAN|0.18||0.0109|TWO_SIDED|95.0|-0.811|-0.106|||ANCOVA|||Week 2: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 2 as an interaction term, baseline DAS28-4(CRP) as the covariate; and participant as a random effect.||-0.106|-0.811|0.0109
72435070|NCT00383188|144383172|SUPERIORITY||LSM Difference|-0.667|STANDARD_ERROR_OF_MEAN|0.208||0.0014|TWO_SIDED|95.0|-1.075|-0.259|||ANCOVA|||Week 2: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 2 as an interaction term, baseline DAS28-4(CRP) as the covariate; and participant as a random effect.||-0.259|-1.075|0.0014
72557922|NCT00205777|144645461|SUPERIORITY_OR_OTHER|||||||0.24||95.0|||||ANOVA|||||||0.24
72557923|NCT00205777|144645462|SUPERIORITY_OR_OTHER|||||||0.25|TWO_SIDED||||||ANOVA|||||||0.25
72383021|NCT01828320|144274527|SUPERIORITY||d (effect size)|0.02||||0.83|TWO_SIDED|||||Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random was used to examine continuous outcomes.|intent-to-treat, multilevel modeling|||||||0.83
72383022|NCT01828320|144274528|SUPERIORITY||d (effect size)|-0.11||||0.85|TWO_SIDED||||||Intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||||||0.85
72383023|NCT01828320|144274529|SUPERIORITY||d (effect size)|-0.55||||0.02|TWO_SIDED|||||Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random was used to examine continuous outcomes.|Intent-to-treat, multilevel modeling|||||||0.02
72383024|NCT01828320|144274530|SUPERIORITY||d (effect size)|-0.33||||0.05|TWO_SIDED|||||Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random was used to examine continuous outcomes.|intent-to-treat, multilevel modeling|||||||0.05
72383025|NCT01828320|144274531|SUPERIORITY||d (effect size)|0.04||||0.88|TWO_SIDED|||||Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random was used to examine continuous outcomes.|intent-to-treat, multilevel modeling|||||||0.88
72557924|NCT00205777|144645462|SUPERIORITY_OR_OTHER|||||||0.07||95.0|||||ANOVA|||||||0.070
72557925|NCT00205777|144645463|SUPERIORITY_OR_OTHER|||||||0.77|TWO_SIDED||||||ANOVA|||||||0.77
72557926|NCT00205777|144645463|SUPERIORITY_OR_OTHER|||||||0.91||95.0|||||ANOVA|||||||0.91
72557927|NCT00205777|144645463|SUPERIORITY_OR_OTHER|||||||0.009||95.0|||||ANOVA|||||||0.009
72383026|NCT01828320|144274532|SUPERIORITY||d (effect size)|0.04||||0.97|TWO_SIDED|||||Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random was used to examine continuous outcomes.|intent-to-treat, multilevel modeling|||||||0.97
72557928|NCT00205777|144645463|SUPERIORITY_OR_OTHER|||||||0.023||95.0|||||ANOVA|||||||0.023
72557929|NCT00205777|144645463|SUPERIORITY_OR_OTHER|||||||0.012||95.0|||||ANOVA|||||||0.012
72618721|NCT01026038|144768109|SUPERIORITY_OR_OTHER||GMT ratio|0.7|||||TWO_SIDED|95.0|0.49|0.9||||||Serotype 6B: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||0.90|0.49|
72435071|NCT00383188|144383172|SUPERIORITY||LSM Difference|-0.447|STANDARD_ERROR_OF_MEAN|0.213||0.0364|TWO_SIDED|95.0|-0.867|-0.028|||ANCOVA|||Week 2: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 2 as an interaction term, baseline DAS28-4(CRP) as the covariate; and participant as a random effect.||-0.028|-0.867|0.0364
72435072|NCT00383188|144383172|SUPERIORITY||LSM Difference|-0.271|STANDARD_ERROR_OF_MEAN|0.185||0.1436|TWO_SIDED|95.0|-0.634|0.092|||ANCOVA|||Week 4: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 4 as an interaction term, baseline DAS28-4(CRP) as the covariate; and participant as a random effect.||0.092|-0.634|0.1436
72435073|NCT00383188|144383172|SUPERIORITY||LSM Difference|-0.404|STANDARD_ERROR_OF_MEAN|0.18||0.0246|TWO_SIDED|95.0|-0.757|-0.052|||ANCOVA|||Week 4: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 4 as an interaction term, baseline DAS28-4(CRP) as the covariate; and participant as a random effect.||-0.052|-0.757|0.0246
72435074|NCT00383188|144383172|SUPERIORITY||LSM Difference|-0.546|STANDARD_ERROR_OF_MEAN|0.208||0.0088|TWO_SIDED|95.0|-0.954|-0.138|||ANCOVA|||Week 4: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 4 as an interaction term, baseline DAS28-4(CRP) as the covariate; and participant as a random effect.||-0.138|-0.954|0.0088
72435075|NCT00383188|144383172|SUPERIORITY||LSM Difference|-0.267|STANDARD_ERROR_OF_MEAN|0.213||0.2121|TWO_SIDED|95.0|-0.686|0.152|||ANCOVA|||Week 4: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 4 as an interaction term, baseline DAS28-4(CRP) as the covariate; and participant as a random effect.||0.152|-0.686|0.2121
72435076|NCT00383188|144383172|SUPERIORITY||LSM Difference|-0.098|STANDARD_ERROR_OF_MEAN|0.185||0.5975|TWO_SIDED|95.0|-0.461|0.265|||ANCOVA|||Week 8: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 8 as an interaction term, baseline DAS28-4(CRP) as the covariate; and participant as a random effect.||0.265|-0.461|0.5975
72435077|NCT00383188|144383172|SUPERIORITY||LSM Difference|-0.464|STANDARD_ERROR_OF_MEAN|0.18||0.0099|TWO_SIDED|95.0|-0.817|-0.112|||ANCOVA|||Week 8: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 8 as an interaction term, baseline DAS28-4(CRP) as the covariate; and participant as a random effect.||-0.112|-0.817|0.0099
72435078|NCT00383188|144383172|SUPERIORITY||LSM Difference|-0.445|STANDARD_ERROR_OF_MEAN|0.208||0.0328|TWO_SIDED|95.0|-0.853|-0.037|||ANCOVA|||Week 8: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 8 as an interaction term, baseline DAS28-4(CRP) as the covariate; and participant as a random effect.||-0.037|-0.853|0.0328
72435079|NCT00383188|144383172|SUPERIORITY||LSM Difference|-0.214|STANDARD_ERROR_OF_MEAN|0.213||0.3162|TWO_SIDED|95.0|-0.633|0.205|||ANCOVA|||Week 8: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 8 as an interaction term, baseline DAS28-4(CRP) as the covariate; and participant as a random effect.||0.205|-0.633|0.3162
72435080|NCT00383188|144383172|SUPERIORITY||LSM Difference|-0.353|STANDARD_ERROR_OF_MEAN|0.185||0.0569|TWO_SIDED|95.0|-0.716|0.01|||ANCOVA|||Week 12: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 12 as an interaction term, baseline DAS28-4(CRP) as the covariate; and participant as a random effect.||0.010|-0.716|0.0569
72557930|NCT00205777|144645464|SUPERIORITY_OR_OTHER|||||||0.79|TWO_SIDED||||||ANOVA|||||||0.79
72435081|NCT00383188|144383172|SUPERIORITY||LSM Difference|-0.449|STANDARD_ERROR_OF_MEAN|0.18||0.0126|TWO_SIDED|95.0|-0.801|-0.096|||ANCOVA|||Week 12: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 12 as an interaction term, baseline DAS28-4(CRP) as the covariate; and participant as a random effect.||-0.096|-0.801|0.0126
72435082|NCT00383188|144383172|SUPERIORITY||LSM Difference|-0.515|STANDARD_ERROR_OF_MEAN|0.208||0.0135|TWO_SIDED|95.0|-0.923|-0.107|||ANCOVA|||Week 12: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 12 as an interaction term, baseline DAS28-4(CRP) as the covariate; and participant as a random effect.||-0.107|-0.923|0.0135
72435083|NCT00383188|144383172|SUPERIORITY||LSM Difference|-0.145|STANDARD_ERROR_OF_MEAN|0.213||0.4979|TWO_SIDED|95.0|-0.564|0.274|||ANCOVA|||Week 12: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 12 as an interaction term, baseline DAS28-4(CRP) as the covariate; and participant as a random effect.||0.274|-0.564|0.4979
72557931|NCT00205777|144645464|SUPERIORITY_OR_OTHER|||||||0.61||95.0|||||ANOVA|||||||0.61
72557932|NCT00205777|144645465|SUPERIORITY_OR_OTHER|||||||0.3|TWO_SIDED||||||ANOVA|||||||0.30
72557933|NCT00205777|144645465|SUPERIORITY_OR_OTHER|||||||0.62||95.0|||||ANOVA|||||||0.62
72557934|NCT00205777|144645465|SUPERIORITY_OR_OTHER|||||||0.28||95.0|||||ANOVA|||||||0.28
72557935|NCT00205777|144645465|SUPERIORITY_OR_OTHER|||||||0.041||95.0|||||ANOVA|||||||0.041
72557936|NCT00205777|144645465|SUPERIORITY_OR_OTHER|||||||0.12||95.0|||||ANOVA|||||||0.12
72618722|NCT01026038|144768109|SUPERIORITY_OR_OTHER||GMT ratio|0.7|||||TWO_SIDED|95.0|0.55|1.01||||||Serotype 6B: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.01|0.55|
72557937|NCT00205777|144645466|SUPERIORITY_OR_OTHER|||||||0.7|TWO_SIDED||||||ANOVA|||||||0.70
72557938|NCT00205777|144645466|SUPERIORITY_OR_OTHER|||||||0.61||95.0|||||ANOVA|||||||0.61
72557939|NCT00205777|144645467|SUPERIORITY_OR_OTHER|||||||0.22|TWO_SIDED||||||ANOVA|||||||0.22
72618723|NCT01026038|144768109|SUPERIORITY_OR_OTHER||GMT ratio|1.1|||||TWO_SIDED|95.0|0.79|1.59||||||Serotype 6B: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.59|0.79|
72383027|NCT01828320|144274533|SUPERIORITY||d (effect size)|0.01||||0.88|TWO_SIDED|||||Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random was used to examine continuous outcomes.|intent-to-treat, multilevel modeling|||"Composite Risk Score of Functioning in Social Domain measured via Ecological Momentary Assessment: Alone"||||0.88
72383028|NCT01828320|144274533|SUPERIORITY||d (effect size)|-0.18||||0.43|TWO_SIDED|||||Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random was used to examine continuous outcomes.|intent-to-treat, multilevel modeling|||"Composite Risk Score of Functioning in Social Domain measured via Ecological Momentary Assessment: With a family member"||||0.43
72383029|NCT01828320|144274533|SUPERIORITY||d (effect size)|0.21||||0.37|TWO_SIDED|||||Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random was used to examine continuous outcomes.|intent-to-treat, multilevel modeling|||"Composite Risk Score of Functioning in Social Domain measured via Ecological Momentary Assessment: With a peer"||||0.37
72383030|NCT01828320|144274534|SUPERIORITY||d (effect size)|0.29||||0.02|TWO_SIDED|||||Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random was used to examine continuous outcomes.|Intent-to-treat, multilevel modeling|||||||0.02
72383031|NCT01828320|144274535|SUPERIORITY||d (effect size)|0.07||||0.49|TWO_SIDED|||||Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random was used to examine continuous outcomes.|intent-to-treat, multilevel modeling|||||||0.49
72383032|NCT01828320|144274536|SUPERIORITY||d (effect size)|0.11||||0.6|TWO_SIDED||||||intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||||||0.60
72383033|NCT01828320|144274537|SUPERIORITY||d (effect size)|0.08||||0.42|TWO_SIDED|||||Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random was used to examine continuous outcomes.|Intent-to-treat, multilevel modeling|||||||0.42
72383034|NCT01828320|144274538|SUPERIORITY||d (effect size)|0.4||||0.01|TWO_SIDED||||||Intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||||||0.01
72383035|NCT02349061|144274600|SUPERIORITY||Odds Ratio (OR)|3.28||||0.0057|TWO_SIDED|95.0|1.41|7.63|||Regression, Logistic|||||7.63|1.41|0.0057
72383036|NCT02349061|144274601|SUPERIORITY||Least Squares (LS) Mean Difference|-1.36||||0.0929|TWO_SIDED|95.0|-2.94|0.23|||Mixed model repeated measures model|||||0.23|-2.94|0.0929
72383037|NCT02349061|144274602|SUPERIORITY||LS Means Difference|-0.383||||0.3944|TWO_SIDED|95.0|-1.271|0.506|||Mixed model repeated measures model|||||0.506|-1.271|0.3944
72504564|NCT03368404|144539911|NON_INFERIORITY|A sample size of 33 evaluable patients per treatment group was calculated to provide at least 90% power to demonstrate non-inferiority of CBL-102 to Vismed Multi. Assumptions included a non-inferiority margin of 2 grades and a standard deviation of 2.5|Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.4|||TWO_SIDED|95.0|-1.34|0.13|||||Treatment difference : CBL-102 - Vismed Multi|||0.13|-1.34|
72383038|NCT02349061|144274603|SUPERIORITY||Odds Ratio (OR)|1.0||||0.9939|TWO_SIDED|95.0|0.43|2.34|||Regression, Logistic|||||2.34|0.43|0.9939
72383039|NCT02349061|144274604|SUPERIORITY||LS Means Difference|-2.17||||0.1032|TWO_SIDED|95.0|-4.78|0.45|||Mixed model repeated measures model|||||0.45|-4.78|0.1032
72383040|NCT02339285|144274605|OTHER|F-test; Treatment effect|||||>|0.1|||||||ANOVA|F(2, 29)||"Null hypothesis: There is no difference baseline and the 4 week follow up in MADRS score between treatment groups.~Alternative hypothesis: There is a difference between baseline and the 4 week follow up MADRS score between treatment groups."||||>0.10
72383041|NCT02339285|144274605|OTHER|F-test; Session effect|||||<|0.001|||||||ANOVA|F(1, 31)||"Null hypothesis: There is no difference baseline and the 4 week follow up in MADRS score between treatment groups.~Alternative hypothesis: There is a difference between baseline and the 4 week follow up MADRS score between treatment groups."||||<0.001
72383042|NCT02339285|144274605|OTHER|F-test; Interaction effect (session x treatment)|||||>|0.1|||||||ANOVA|F(2,29)||||||>0.10
72383043|NCT02339285|144274606|OTHER|F-test; Condition effect|||||<|0.05|||||||ANOVA|F(2,21.595)||"Null hypothesis: There is no difference in changes of alpha frequency power between baseline EEG and EEG on Day 5 of Stimulation between treatment groups.~Alternative hypothesis: There is a difference in changes of alpha frequency power between baseline EEG and EEG on Day 5 of Stimulation between treatment groups."||||<0.05
72383044|NCT02339285|144274606|OTHER|F-test; Region effect (region defined as region of brain - frontal, parietal, occipital temporal)|||||<|0.001|||||||ANOVA|F(3, 79.358)||"Null hypothesis: There is no difference in changes of alpha frequency power between baseline EEG and EEG on Day 5 of Stimulation between treatment groups.~Alternative hypothesis: There is a difference in changes of alpha frequency power between baseline EEG and EEG on Day 5 of Stimulation between treatment groups."||||<0.001
72383045|NCT02339285|144274606|OTHER|F-test; Interaction effect (region x condition)|||||>|0.1|||||||ANOVA|F(6, 68.284)||"Null hypothesis: There is no difference in changes of alpha frequency power between baseline EEG and EEG on Day 5 of Stimulation between treatment groups.~Alternative hypothesis: There is a difference in changes of alpha frequency power between baseline EEG and EEG on Day 5 of Stimulation between treatment groups."||||>0.10
72383046|NCT02339285|144274607|OTHER||||||>|0.1|||||||ANOVA|||"Null hypothesis: There is no difference in changes of alpha frequency power between baseline EEG and EEG 4 weeks after completion of the intervention between treatment groups.~Alternative hypothesis: There is a difference in changes of alpha frequency power between baseline EEG and EEG 4 weeks after completion of the intervention between treatment groups."||||>0.10
72383047|NCT00137631|144274617|SUPERIORITY_OR_OTHER||Rate Ratio|0.58|||<|0.05||95.0|0.33|1.01|||negative binomial regression|||||1.01|0.33|< 0.05
72504565|NCT03368404|144539912|SUPERIORITY|||||||0.0592||||||Significance level of 0.05|ANCOVA|Adjustment for baseline||||||0.0592
72383048|NCT00137631|144274618|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.33|||<|0.05||95.0|1.05|1.68|||generalized estimating equations|Tests intervention efficacy over all study periods (baseline, 3-months, and 6-months)||||1.68|1.05|< 0.05
72504566|NCT03368404|144539913|SUPERIORITY||||||>|0.05||||||Significance level of 0.05|ANCOVA|Adjustment for baseline||||||>0.05
72557940|NCT00205777|144645467|SUPERIORITY_OR_OTHER|||||||0.76||95.0|||||ANOVA|||||||0.76
72557941|NCT00205777|144645467|SUPERIORITY_OR_OTHER|||||||0.26||95.0|||||ANOVA|||||||0.26
72383049|NCT00137631|144274619|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.17|||<|0.05||95.0|0.69|1.98|||Mixed Models Analysis|||||1.98|0.69|< 0.05
72383050|NCT00137631|144274620|SUPERIORITY_OR_OTHER||Rate Ratio|0.49|||<|0.05||95.0|0.28|0.87|||generalized estimating equations|Tests intervention efficacy over all study periods (baseline, 3-months, and 6-months)||||0.87|0.28|< 0.05
72383051|NCT00137631|144274621|SUPERIORITY_OR_OTHER||Rate Ratio|0.8|||<|0.05||95.0|0.42|1.53|||generalized estimating equations|Tests intervention efficacy over all study periods (baseline, 3-months, and 6-months)||||1.53|0.42|< 0.05
72383052|NCT01859143|144274639|NON_INFERIORITY_OR_EQUIVALENCE|Pre-specified equivalence criterion for fever within 7 days of vaccination mentioned that the upper limit of 95 percent (%) confidence interval (CI) for difference in percentage of participants with fever \>=101 degrees F should be less than 5 percentage points.|Percent difference|0.4|||||TWO_SIDED|95.0|-5.3|2.6|||||A two-sided 95% CI was constructed using the exact method based on the score statistic proposed by Chan and Zhang.|||2.6|-5.3|
72435084|NCT00383188|144383172|SUPERIORITY||LSM Difference|0.271|STANDARD_ERROR_OF_MEAN|0.195||0.1643|TWO_SIDED|95.0|-0.111|0.653|||ANCOVA|||Week 16: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 16 as an interaction term, baseline DAS28-4(CRP) as the covariate; and participant as a random effect.||0.653|-0.111|0.1643
72435085|NCT00383188|144383172|SUPERIORITY||LSM Difference|0.081|STANDARD_ERROR_OF_MEAN|0.185||0.6611|TWO_SIDED|95.0|-0.282|0.445|||ANCOVA|||Week 16: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 16 as an interaction term, baseline DAS28-4(CRP) as the covariate; and participant as a random effect.||0.445|-0.282|0.6611
72435086|NCT00383188|144383172|SUPERIORITY||LSM Difference|0.097|STANDARD_ERROR_OF_MEAN|0.219||0.6587|TWO_SIDED|95.0|-0.333|0.526|||ANCOVA|||Week 16: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 16 as an interaction term, baseline DAS28-4(CRP) as the covariate; and participant as a random effect.||0.526|-0.333|0.6587
72435087|NCT00383188|144383172|SUPERIORITY||LSM Difference|0.154|STANDARD_ERROR_OF_MEAN|0.223||0.4903|TWO_SIDED|95.0|-0.284|0.592|||ANCOVA|||Week 16: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 16 as an interaction term, baseline DAS28-4(CRP) as the covariate; and participant as a random effect.||0.592|-0.284|0.4903
72435088|NCT00383188|144383174|SUPERIORITY||LSM Difference|-0.119|STANDARD_ERROR_OF_MEAN|0.09||0.1857|TWO_SIDED|95.0|-0.296|0.057|||ANCOVA|||Week 1: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 1 as an interaction term, baseline HAQ-DI as the covariate and participant as a random effect.||0.057|-0.296|0.1857
72435089|NCT00383188|144383174|SUPERIORITY||LSM Difference|-0.277|STANDARD_ERROR_OF_MEAN|0.089||0.0019|TWO_SIDED|95.0|-0.451|-0.103|||ANCOVA|||Week 1: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 1 as an interaction term, baseline HAQ-DI as the covariate and participant as a random effect.||-0.103|-0.451|0.0019
72435090|NCT00383188|144383174|SUPERIORITY||LSM Difference|-0.244|STANDARD_ERROR_OF_MEAN|0.103||0.0178|TWO_SIDED|95.0|-0.446|-0.042|||ANCOVA|||Week 1: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 1 as an interaction term, baseline HAQ-DI as the covariate and participant as a random effect.||-0.042|-0.446|0.0178
72435091|NCT00383188|144383174|SUPERIORITY||LSM Difference|-0.098|STANDARD_ERROR_OF_MEAN|0.106||0.3547|TWO_SIDED|95.0|-0.305|0.11|||ANCOVA|||Week 1: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 1 as an interaction term, baseline HAQ-DI as the covariate and participant as a random effect.||0.110|-0.305|0.3547
72435092|NCT00383188|144383174|SUPERIORITY||LSM Difference|-0.135|STANDARD_ERROR_OF_MEAN|0.089||0.1301|TWO_SIDED|95.0|-0.31|0.04|||ANCOVA|||Week 2: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 2 as an interaction term, baseline HAQ-DI as the covariate and participant as a random effect.||0.040|-0.310|0.1301
72435093|NCT00383188|144383174|SUPERIORITY||LSM Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.088||0.0313|TWO_SIDED|95.0|-0.363|-0.017|||ANCOVA|||Week 2: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 2 as an interaction term, baseline HAQ-DI as the covariate and participant as a random effect.||-0.017|-0.363|0.0313
72504567|NCT03368404|144539914|SUPERIORITY||||||>|0.05||||||Significance level 0.05|ANCOVA|Adjustment for baseline||||||>0.05
72504568|NCT03368404|144539915|SUPERIORITY||||||>|0.05||||||Significance level of 0.05|ANCOVA|Adjustment for baseline||||||>0.05
72504569|NCT03368404|144539916|SUPERIORITY|||||||0.0176||||||Significance level 0.05|ANCOVA|||Change from Baseline in Global Sum Score of Dry Eye Symptoms at Day 28 (Visit 4)||||0.0176
72504570|NCT03368404|144539916|SUPERIORITY|||||||0.001||||||Significance level 0.05|ANCOVA|Adjustment to baseline||Change from Baseline in Global Sum Score of Dry Eye Symptoms at Day 90 (Visit 5)||||0.0010
72504571|NCT03368404|144539917|SUPERIORITY|||||||0.0251||||||Significance level 0.05|ANCOVA|Adjustment for baseline||"Ocular Surface Disease-Quality of Life (OSD-QoL®) dimension:~Daily Activities"||||0.0251
72504572|NCT03368404|144539917|SUPERIORITY|||||||0.0015||||||Significance level of 0.05|ANCOVA|Adjustment for baseline||"Ocular Surface Disease-Quality of Life (OSD-QoL®) dimension:~Difficulties with work and handicap"||||0.0015
72383053|NCT01859143|144274640|SUPERIORITY_OR_OTHER||Percent difference|11.9|||||TWO_SIDED|95.0|-1.9|23.9|||||Any symptom within 7 days of vaccination: Difference in percentage of participants and 95% CI were constructed based on Chan and Zhang's method.|||23.9|-1.9|
72383054|NCT01859143|144274640|SUPERIORITY_OR_OTHER||Percent difference|0.8|||||TWO_SIDED|95.0|-4.9|3.3|||||Fever \>100 degrees F within 7 days of vaccination: Difference in percentage of participants and 95% CI were constructed based on Chan and Zhang's method.|||3.3|-4.9|
72383055|NCT01859143|144274640|SUPERIORITY_OR_OTHER||Percent difference|0.0|||||TWO_SIDED|95.0|-6.1|1.8|||||Fever \>102 degrees F within 7 days of vaccination: Difference in percentage of participants and 95% CI were constructed based on Chan and Zhang's method.|||1.8|-6.1|
72435094|NCT00383188|144383174|SUPERIORITY||LSM Difference|-0.219|STANDARD_ERROR_OF_MEAN|0.102||0.0323|TWO_SIDED|95.0|-0.42|-0.019|||ANCOVA|||Week 2: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 2 as an interaction term, baseline HAQ-DI as the covariate and participant as a random effect.||-0.019|-0.420|0.0323
72435095|NCT00383188|144383174|SUPERIORITY||LSM Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.105||0.6318|TWO_SIDED|95.0|-0.256|0.156|||ANCOVA|||Week 2: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 2 as an interaction term, baseline HAQ-DI as the covariate and participant as a random effect.||0.156|-0.256|0.6318
72435096|NCT00383188|144383174|SUPERIORITY||LSM Difference|-0.055|STANDARD_ERROR_OF_MEAN|0.089||0.5388|TWO_SIDED|95.0|-0.23|0.12|||ANCOVA|||Week 4: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 4 as an interaction term, baseline HAQ-DI as the covariate and participant as a random effect.||0.120|-0.230|0.5388
72435097|NCT00383188|144383174|SUPERIORITY||LSM Difference|-0.157|STANDARD_ERROR_OF_MEAN|0.088||0.0755|TWO_SIDED|95.0|-0.329|0.016|||ANCOVA|||Week 4: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 4 as an interaction term, baseline HAQ-DI as the covariate and participant as a random effect.||0.016|-0.329|0.0755
72494197|NCT04418765|144517317|OTHER|Testing sequence: 1. Change in MMDs (Weeks 1-12) 300 mg vs placebo; 2. 50% responders for MMDs (Weeks 1-12) 300 mg vs placebo; 3. Change in MMDs (Weeks 1-12) 100 mg vs placebo; 4. 50% responders for MMDs (Weeks 1-12) 100 mg vs placebo; 5a. Change in MMDs (Weeks 13-24), 5b. 75% responders for MMDs (Weeks 1-12), 5c. Change in HIT-6 (Week 12) 300 mg vs placebo; 6a. Change in MMDs (Weeks 13-24), 6b. 75% responders for MMDs (Weeks 1-12), 6c. Change in HIT-6 (Week 12) 100 mg vs placebo.|Mean Difference (Final Values)|-5.4|STANDARD_ERROR_OF_MEAN|0.63|<|0.0001|TWO_SIDED|95.0|-6.7|-4.2||Threshold for significance: The consecutive order of the smallest (p1), the second smallest (p2), and the largest p-value (p3) had to be \<α/3, \<α/2, and \<α, where α = 0.05. Here it is test no. 5c of testing order.|Mixed Models Analysis|||"Analysis was performed using MMRM with the following fixed effects: visit, country, stratification factor (MHDs at baseline: ≤14/\>14) and treatment as factors, baseline HIT-6 Total Score as a continuous covariate, baseline score-by-visit interaction, treatment-by-visit interaction, and stratum-by-visit interaction.~A testing strategy (sequence of tests) was applied to ensure protection of the type 1 error.~Testing continued only, if the previous comparison was statistically significant."||-4.2|-6.7|<0.0001
72435098|NCT00383188|144383174|SUPERIORITY||LSM Difference|-0.219|STANDARD_ERROR_OF_MEAN|0.102||0.0323|TWO_SIDED|95.0|-0.42|-0.019|||ANCOVA|||Week 4: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 4 as an interaction term, baseline HAQ-DI as the covariate and participant as a random effect.||-0.019|-0.420|0.0323
72435099|NCT00383188|144383174|SUPERIORITY||LSM Difference|-0.072|STANDARD_ERROR_OF_MEAN|0.105||0.4948|TWO_SIDED|95.0|-0.277|0.134|||ANCOVA|||Week 4: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 4 as an interaction term, baseline HAQ-DI as the covariate and participant as a random effect.||0.134|-0.277|0.4948
72435100|NCT00383188|144383174|SUPERIORITY||LSM Difference|0.06|STANDARD_ERROR_OF_MEAN|0.089||0.5022|TWO_SIDED|95.0|-0.115|0.235|||ANCOVA|||Week 8: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 8 as an interaction term, baseline HAQ-DI as the covariate and participant as a random effect.||0.235|-0.115|0.5022
72435101|NCT00383188|144383174|SUPERIORITY||LSM Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.088||0.0307|TWO_SIDED|95.0|-0.363|-0.018|||ANCOVA|||Week 8: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 8 as an interaction term, baseline HAQ-DI as the covariate and participant as a random effect.||-0.018|-0.363|0.0307
72435102|NCT00383188|144383174|SUPERIORITY||LSM Difference|-0.172|STANDARD_ERROR_OF_MEAN|0.102||0.0933|TWO_SIDED|95.0|-0.372|0.029|||ANCOVA|||Week 8: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 8 as an interaction term, baseline HAQ-DI as the covariate and participant as a random effect.||0.029|-0.372|0.0933
72435103|NCT00383188|144383174|SUPERIORITY||LSM Difference|0.027|STANDARD_ERROR_OF_MEAN|0.105||0.7967|TWO_SIDED|95.0|-0.179|0.233|||ANCOVA|||Week 8: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 8 as an interaction term, baseline HAQ-DI as the covariate and participant as a random effect.||0.233|-0.179|0.7967
72435104|NCT00383188|144383174|SUPERIORITY||LSM Difference|-0.034|STANDARD_ERROR_OF_MEAN|0.089||0.7059|TWO_SIDED|95.0|-0.208|0.141|||ANCOVA|||Week 12: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 12 as an interaction term, baseline HAQ-DI as the covariate and participant as a random effect.||0.141|-0.208|0.7059
72435105|NCT00383188|144383174|SUPERIORITY||LSM Difference|-0.213|STANDARD_ERROR_OF_MEAN|0.088||0.0154|TWO_SIDED|95.0|-0.386|-0.041|||ANCOVA|||Week 12: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 12 as an interaction term, baseline HAQ-DI as the covariate and participant as a random effect.||-0.041|-0.386|0.0154
72435106|NCT00383188|144383174|SUPERIORITY||LSM Difference|-0.136|STANDARD_ERROR_OF_MEAN|0.102||0.1836|TWO_SIDED|95.0|-0.336|0.065|||ANCOVA|||Week 12: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 12 as an interaction term, baseline HAQ-DI as the covariate and participant as a random effect.||0.065|-0.336|0.1836
72435107|NCT00383188|144383174|SUPERIORITY||LSM Difference|0.078|STANDARD_ERROR_OF_MEAN|0.105||0.4577|TWO_SIDED|95.0|-0.128|0.284|||ANCOVA|||Week 12: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 12 as an interaction term, baseline HAQ-DI as the covariate and participant as a random effect.||0.284|-0.128|0.4577
72435108|NCT00383188|144383174|SUPERIORITY||LSM Difference|0.082|STANDARD_ERROR_OF_MEAN|0.092||0.3692|TWO_SIDED|95.0|-0.098|0.262|||ANCOVA|||Week 16: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 16 as an interaction term, baseline HAQ-DI as the covariate and participant as a random effect.||0.262|-0.098|0.3692
72557942|NCT00205777|144645467|SUPERIORITY_OR_OTHER|||||||0.89||95.0|||||ANOVA|||||||0.89
72383056|NCT01859143|144274640|SUPERIORITY_OR_OTHER||Percent difference|0.0|||||TWO_SIDED|95.0|-6.1|1.8|||||Fever \>103 degrees F within 7 days of vaccination: Difference in percentage of participants and 95% CI were constructed based on Chan and Zhang's method.|||1.8|-6.1|
72383057|NCT01859143|144274640|SUPERIORITY_OR_OTHER||Percent difference|8.9|||||TWO_SIDED|95.0|-2.6|17.7|||||Runny nose within 7 days of vaccination: Difference in percentage of participants and 95% CI were constructed based on Chan and Zhang's method.|||17.7|-2.6|
72383058|NCT01859143|144274640|SUPERIORITY_OR_OTHER||Percent difference|6.2|||||TWO_SIDED|95.0|-2.2|11.6|||||Sore throat within 7 days of vaccination: Difference in percentage of participants and 95% CI were constructed based on Chan and Zhang's method.|||11.6|-2.2|
72383059|NCT01859143|144274640|SUPERIORITY_OR_OTHER||Percent difference|-0.5|||||TWO_SIDED|95.0|-9.3|4.7|||||Cough within 7 days of vaccination: Difference in percentage of participants and 95% CI were constructed based on Chan and Zhang's method.|||4.7|-9.3|
72383060|NCT01859143|144274640|SUPERIORITY_OR_OTHER||Percent difference|0.0|||||TWO_SIDED|95.0|-6.1|1.8|||||Vomiting within 7 days of vaccination: Difference in percentage of participants and 95% CI were constructed based on Chan and Zhang's method.|||1.8|-6.1|
72383061|NCT01859143|144274640|SUPERIORITY_OR_OTHER||Percent difference|-0.1|||||TWO_SIDED|95.0|-8.0|4.3|||||Muscle aches within 7 days of vaccination: Difference in percentage of participants and 95% CI were constructed based on Chan and Zhang's method.|||4.3|-8.0|
72383062|NCT01859143|144274640|SUPERIORITY_OR_OTHER||Percent difference|1.7|||||TWO_SIDED|95.0|-4.1|4.4|||||Chills within 7 days of vaccination: Difference in percentage of participants and 95% CI were constructed based on Chan and Zhang's method.|||4.4|-4.1|
72383063|NCT01859143|144274640|SUPERIORITY_OR_OTHER||Percent difference|3.2|||||TWO_SIDED|95.0|-6.5|9.8|||||Decreased activity (tiredness) within 7 days of vaccination: Difference in percentage of participants and 95% CI were constructed based on Chan and Zhang's method.|||9.8|-6.5|
72383064|NCT01859143|144274640|SUPERIORITY_OR_OTHER||Percent difference|3.5|||||TWO_SIDED|95.0|-7.8|11.9|||||Headache within 7 days of vaccination: Difference in percentage of participants and 95% CI were constructed based on Chan and Zhang's method.|||11.9|-7.8|
72383065|NCT01859143|144274640|SUPERIORITY_OR_OTHER||Percent difference|12.3|||||TWO_SIDED|95.0|-1.6|24.4|||||Any symptom within 14 days of vaccination: Difference in percentage of participants and 95% CI were constructed based on Chan and Zhang's method.|||24.4|-1.6|
72383066|NCT01859143|144274640|SUPERIORITY_OR_OTHER||Percent difference|1.2|||||TWO_SIDED|95.0|-4.5|3.9|||||Fever \>100 degrees F within 14 days of vaccination: Difference in percentage of participants and 95% CI were constructed based on Chan and Zhang's method.|||3.9|-4.5|
72383067|NCT01859143|144274640|SUPERIORITY_OR_OTHER||Percent difference|0.8|||||TWO_SIDED|95.0|-4.9|3.3|||||Fever \>=101 degrees F within 14 days of vaccination: Difference in percentage of participants and 95% CI were constructed based on Chan and Zhang's method.|||3.3|-4.9|
72504573|NCT03368404|144539917|SUPERIORITY|||||||0.2024||||||Significance level 0.05|ANCOVA|Adjustment for baseline||"Ocular Surface Disease-Quality if Life (OSD-QoL®) dimension:~Giving up makeup"||||0.2024
72383068|NCT01859143|144274640|SUPERIORITY_OR_OTHER||Percent difference|0.0|||||TWO_SIDED|95.0|-6.1|1.8|||||Fever \>102 degrees F within 14 days of vaccination: Difference in percentage of participants and 95% CI were constructed based on Chan and Zhang's method.|||1.8|-6.1|
72383069|NCT01859143|144274640|SUPERIORITY_OR_OTHER||Percent difference|0.0|||||TWO_SIDED|95.0|-6.1|1.8|||||Fever \>103 degrees F within 14 days of vaccination: Difference in percentage of participants and 95% CI were constructed based on Chan and Zhang's method.|||1.8|-6.1|
72383070|NCT01859143|144274640|SUPERIORITY_OR_OTHER||Percent difference|9.7|||||TWO_SIDED|95.0|-1.8|18.6|||||Runny nose within 14 days of vaccination: Difference in percentage of participants and 95% CI were constructed based on Chan and Zhang's method.|||18.6|-1.8|
72383071|NCT01859143|144274640|SUPERIORITY_OR_OTHER||Percent difference|4.4|||||TWO_SIDED|95.0|-5.3|11.2|||||Sore throat within 14 days of vaccination: Difference in percentage of participants and 95% CI were constructed based on Chan and Zhang's method.|||11.2|-5.3|
72383072|NCT01859143|144274640|SUPERIORITY_OR_OTHER||Percent difference|0.3|||||TWO_SIDED|95.0|-8.6|5.7|||||Cough within 14 days of vaccination: Difference in percentage of participants and 95% CI were constructed based on Chan and Zhang's method.|||5.7|-8.6|
72383073|NCT01859143|144274640|SUPERIORITY_OR_OTHER||Percent difference|0.4|||||TWO_SIDED|95.0|-5.3|2.6|||||Vomiting within 14 days of vaccination: Difference in percentage of participants and 95% CI were constructed based on Chan and Zhang's method.|||2.6|-5.3|
72383074|NCT01859143|144274640|SUPERIORITY_OR_OTHER||Percent difference|0.3|||||TWO_SIDED|95.0|-7.8|4.8|||||Muscle aches within 14 days of vaccination: Difference in percentage of participants and 95% CI were constructed based on Chan and Zhang's method.|||4.8|-7.8|
72383075|NCT01859143|144274640|SUPERIORITY_OR_OTHER||Percent difference|2.5|||||TWO_SIDED|95.0|-3.3|5.5|||||Chills within 14 days of vaccination: Difference in percentage of participants and 95% CI were constructed based on Chan and Zhang's method.|||5.5|-3.3|
72383076|NCT01859143|144274640|SUPERIORITY_OR_OTHER||Percent difference|4.4|||||TWO_SIDED|95.0|-5.3|11.2|||||Decreased activity (tiredness) within 14 days of vaccination: Difference in percentage of participants and 95% CI were constructed based on Chan and Zhang's method.|||11.2|-5.3|
72383077|NCT01859143|144274640|SUPERIORITY_OR_OTHER||Percent difference|3.0|||||TWO_SIDED|95.0|-8.7|12.0|||||Headache within 14 days of vaccination: Difference in percentage of participants and 95% CI were constructed based on Chan and Zhang's method.|||12.0|-8.7|
72504574|NCT03368404|144539917|SUPERIORITY|||||||0.0421||||||Significance level 0.05|ANCOVA|Adjustment for baseline||"Ocular Surface Disease-Quality if Life (OSD-QoL®) dimension:~Acknowledgement of the Disease"||||0.0421
72504575|NCT03368404|144539917|SUPERIORITY|||||||0.3945||||||Significance level 0.05|ANCOVA|Adjustment for baseline||"Ocular Surface Disease-Quality if Life (OSD-QoL®) dimension:~Acceptance of the disease"||||0.3945
72504576|NCT03368404|144539917|SUPERIORITY|||||||0.0536||||||Significance level of 0.05|ANCOVA|Adjustment for baseline||"Ocular Surface Disease-Quality if Life (OSD-QoL®) dimension:~Fear for the Future"||||0.0536
72504577|NCT03368404|144539917|SUPERIORITY|||||||0.1998||||||Significance level of 0.05|ANCOVA|Adjustment for baseline||"Ocular Surface Disease-Quality if Life (OSD-QoL®) dimension:~Emotional well-being"||||0.1998
72504578|NCT03368404|144539917|SUPERIORITY|||||||0.0306||||||Significance level of 0.05|ANCOVA|Adjustment for baseline||"Ocular Surface Disease-Quality of Life (OSD-QoL®) questions:~Global Question"||||0.0306
72504579|NCT03368404|144539918|SUPERIORITY||||||>|0.05||||||Significance level of 0.05|ANCOVA|Adjustment for baseline||||||>0.05
72383078|NCT00438451|144274644|SUPERIORITY_OR_OTHER|||||||0.0201||95.0|||||Fisher Exact|||||||0.0201
72383079|NCT00438451|144274644|SUPERIORITY_OR_OTHER|||||||0.1536||95.0|||||Fisher Exact|||||||0.1536
72383080|NCT00438451|144274644|SUPERIORITY_OR_OTHER|||||||0.3615||95.0|||||Fisher Exact|||||||0.3615
72383081|NCT00438451|144274644|SUPERIORITY_OR_OTHER|||||||0.0478||95.0|||||Fisher Exact|||||||0.0478
72383082|NCT00438451|144274644|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.838||||0.0578|TWO_SIDED|95.0|1.092|3.093|||Regression, Logistic|adjusted for treatment (p=0.0578), country (p=0.4649), pooled sites (p=0.4420) and number of concurrent diseases (p=0.0192)|"Odds ratio given here is for comparison LEV vs CBZ: OR=1.838 KI=(1.092-3.093) LEV vs LTG: OR=1.169 KI=(0.689-1.984) CBZ vs LTG: OR=0.636 KI=(0.377-1.073) Number of concurrent diseases: OR=0.921 KI=(0.859-0.987)"|||3.093|1.092|0.0578
72383083|NCT00438451|144274645|SUPERIORITY_OR_OTHER|||||||0.0596||95.0|||||Log Rank|||||||0.0596
72383084|NCT00438451|144274646|SUPERIORITY_OR_OTHER|||||||0.2517||95.0|||||Fisher Exact|||||||0.2517
72383085|NCT00438451|144274647|SUPERIORITY_OR_OTHER|||||||0.3303||95.0|||||Fisher Exact|||||||0.3303
72383086|NCT00438451|144274648|SUPERIORITY_OR_OTHER|||||||0.5022||95.0|||||Log Rank|||||||0.5022
72383087|NCT02413372|144274656|SUPERIORITY||Mean Difference (Final Values)|-7.17|||||TWO_SIDED|90.0|-9.09|-5.26|||||mean difference in adjusted change from baseline vs placebo|Day 57||-5.26|-9.09|
72435109|NCT00383188|144383174|SUPERIORITY||LSM Difference|0.065|STANDARD_ERROR_OF_MEAN|0.09||0.4677|TWO_SIDED|95.0|-0.111|0.241|||ANCOVA|||Week 16: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 16 as an interaction term, baseline HAQ-DI as the covariate and participant as a random effect.||0.241|-0.111|0.4677
72435110|NCT00383188|144383174|SUPERIORITY||LSM Difference|0.1|STANDARD_ERROR_OF_MEAN|0.106||0.3427|TWO_SIDED|95.0|-0.107|0.307|||ANCOVA|||Week 16: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 16 as an interaction term, baseline HAQ-DI as the covariate and participant as a random effect.||0.307|-0.107|0.3427
72435111|NCT00383188|144383174|SUPERIORITY||LSM Difference|0.135|STANDARD_ERROR_OF_MEAN|0.108||0.212|TWO_SIDED|95.0|-0.077|0.347|||ANCOVA|||Week 16: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 16 as an interaction term, baseline HAQ-DI as the covariate and participant as a random effect.||0.347|-0.077|0.2120
72504580|NCT03368404|144539919|SUPERIORITY||||||>|0.05||||||Significance level 0.05|ANCOVA|Adjustment for baseline||||||>0.05
72504581|NCT03368404|144539920|SUPERIORITY|||||||0.0017||||||Significance level of 0.05|Wilcoxon (Mann-Whitney)|||||||0.0017
72504582|NCT02104180|144539965|NON_INFERIORITY|An estimate of the difference between the pain felt by patient during the two dressings removals along with a 95% confidence interval (CI) has been derived. If the upper limit of the confidence interval was less than 13 mm, clinical non-inferiority of Tulle Gras versus Urgotul has been demonstrated.|Mean Difference (Final Values)|0.26|||||TWO_SIDED|95.0|-1.339|1.864|||||The pain intensity has been analyzed using analysis of variance (ANOVA). The model for this cross-over study included sequence, period and treatment as fixed effects and subject within sequence as random effect.|||1.864|-1.339|
72557943|NCT00205777|144645467|SUPERIORITY_OR_OTHER|||||||0.17||95.0|||||ANOVA|||||||0.17
72383088|NCT02413372|144274656|SUPERIORITY||Mean Difference (Final Values)|-5.19|||||TWO_SIDED|90.0|-7.14|-3.25|||||mean difference in adjusted change from baseline vs placebo|Day 57||-3.25|-7.14|
72383089|NCT02413372|144274656|SUPERIORITY||Mean Difference (Final Values)|-5.43||||0.0004|TWO_SIDED|90.0|-8.01|-2.84|||t-test, 1 sided||mean difference in adjusted change from baseline vs placebo|Day 112||-2.84|-8.01|0.0004
72383090|NCT02413372|144274656|SUPERIORITY||Mean Difference (Final Values)|-3.85||||0.0084|TWO_SIDED|90.0|-6.47|-1.23|||t-test, 1 sided||mean difference in adjusted change from baseline vs placebo|Day 112||-1.23|-6.47|0.0084
72383091|NCT00739999|144274682|SUPERIORITY_OR_OTHER_LEGACY||Atorvastatin CL/F based on 70 kg BW|699.0|||||TWO_SIDED|95.0|570.0|881.0|||non-linear mixed-effects model|Measures of parameter estimation uncertainty (95% CI) were determined by non-parametric bootstrap analysis.||Atorvastatin apparent clearance (CL/F) was described as a function of body weight using an allometric equation. The estimated parameter given is an extrapolation of the model for participants who weigh 70 kg.||881|570|
72383092|NCT01925274|144274743|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-35.71||||0.164|TWO_SIDED|95.0|-83.4|12.0|||Chi-squared|||||12.0|-83.4|0.164
72383093|NCT00777205|144274796|SUPERIORITY_OR_OTHER||Slope|0.22|||<|0.05|TWO_SIDED|95.0|-1.57|2.01|||Mixed Models Analysis|||||2.01|-1.57|<0.05
72383094|NCT00777205|144274797|SUPERIORITY_OR_OTHER||Slope|-0.39|||<|0.05|TWO_SIDED|95.0|-2.03|1.24|||Mixed Models Analysis|||||1.24|-2.03|<0.05
72383095|NCT00777205|144274798|SUPERIORITY_OR_OTHER||Slope|0.81|||<|0.05|TWO_SIDED|95.0|-0.93|2.55|||Mixed Models Analysis|||||2.55|-0.93|<0.05
72383096|NCT00777205|144274799|SUPERIORITY_OR_OTHER||Slope|-0.039|||<|0.05|TWO_SIDED|95.0|-2.66|1.89|||Mixed Models Analysis|||||1.89|-2.66|<0.05
72383097|NCT00777205|144274800|SUPERIORITY_OR_OTHER||Slope|-0.08|||||TWO_SIDED|95.0|-3.31|3.16||||||||3.16|-3.31|
72383098|NCT03053271|144274824|OTHER|No statistical test was done as only 4 subjects could be enrolled, none met criteria for randomization, and the study was discontinued by the Sponsor.|||||||||||||||||No statistical test was done as only 4 subjects could be enrolled, none met criteria for randomization, and the study was discontinued by the Sponsor.|||
72383099|NCT00943124|144274866|NON_INFERIORITY_OR_EQUIVALENCE|Power: If the true geometric mean ratio (GMR MK0524B/Simvastatin + MK0524A) is 1.00 for all the eight primary endpoints, then a sample size of N=220 subjects provides this study with greater than 99.2% probability of observing the 90% confidence intervals (CIs) of all the eight endpoints to be contained within \[0.80, 1.25\], assuming nonnegative associations among the 8 endpoints.|Least-Squares Mean Ratio|1.14||||||90.0|1.09|1.2||||||Least-Squares Mean Ratio (Fixed Dose Combination (FDC)/Co-administration)||1.20|1.09|
72383100|NCT00943124|144274867|NON_INFERIORITY_OR_EQUIVALENCE|Power: If the true geometric mean ratio (GMR MK0524B/Simvastatin + MK0524A) is 1.00 for all the eight primary endpoints, then a sample size of N=220 subjects provides this study with greater than 99.2% probability of observing the 90% confidence intervals (CIs) of all the eight endpoints to be contained within \[0.80, 1.25\], assuming nonnegative associations among the 8 endpoints.|Least-Squares Mean Ratio|1.11||||||90.0|1.05|1.16||||||Least-Squares Mean Ratio (Fixed Dose Combination (FDC)/Co-administration)||1.16|1.05|
72435112|NCT00383188|144383175|SUPERIORITY||LSM Difference|-0.587|STANDARD_ERROR_OF_MEAN|0.337||0.0815|TWO_SIDED|95.0|-1.248|0.074|||ANCOVA|||Week 1: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 1 as an interaction term, baseline Pain Intensity Domain of mBPI as the covariate; and participant as a random effect.||0.074|-1.248|0.0815
72383101|NCT00943124|144274868|NON_INFERIORITY_OR_EQUIVALENCE|Power: If the true geometric mean ratio (GMR MK0524B/Simvastatin + MK0524A) is 1.00 for all the eight primary endpoints, then a sample size of N=220 subjects provides this study with greater than 99.2% probability of observing the 90% confidence intervals (CIs) of all the eight endpoints to be contained within \[0.80, 1.25\], assuming nonnegative associations among the 8 endpoints.|Least-Squares Mean Ratio|0.97||||||90.0|0.93|1.0||||||Least-Squares Mean Ratio (Fixed Dose Combination (FDC)/Co-administration)||1.00|0.93|
72383102|NCT00943124|144274869|NON_INFERIORITY_OR_EQUIVALENCE|Power: If the true geometric mean ratio (GMR MK0524B/Simvastatin + MK0524A) is 1.00 for all the eight primary endpoints, then a sample size of N=220 subjects provides this study with greater than 99.2% probability of observing the 90% confidence intervals (CIs) of all the eight endpoints to be contained within \[0.80, 1.25\], assuming nonnegative associations among the 8 endpoints.|Least-Squares Mean Ratio|0.92||||||90.0|0.87|0.97||||||Least-Squares Mean Ratio (Fixed Dose Combination (FDC)/Co-administration)||0.97|0.87|
72383103|NCT00943124|144274870|NON_INFERIORITY_OR_EQUIVALENCE|Power: If the true geometric mean ratio (GMR MK0524B/Simvastatin + MK0524A) is 1.00 for all the eight primary endpoints, then a sample size of N=220 subjects provides this study with greater than 99.2% probability of observing the 90% confidence intervals (CIs) of all the eight endpoints to be contained within \[0.80, 1.25\], assuming nonnegative associations among the 8 endpoints.|Least-Squares Mean Ratio|1.02||||||90.0|0.99|1.04||||||Least-Squares Mean Ratio (Fixed Dose Combination (FDC)/Co-administration)||1.04|0.99|
72383104|NCT00943124|144274871|NON_INFERIORITY_OR_EQUIVALENCE|Power: If the true geometric mean ratio (GMR MK0524B/Simvastatin + MK0524A) is 1.00 for all the eight primary endpoints, then a sample size of N=220 subjects provides this study with greater than 99.2% probability of observing the 90% confidence intervals (CIs) of all the eight endpoints to be contained within \[0.80, 1.25\], assuming nonnegative associations among the 8 endpoints.|Least-Squares Mean Ratio|1.08||||||90.0|1.02|1.14||||||Least-Squares Mean Ratio (Fixed Dose Combination (FDC)/Co-administration)||1.14|1.02|
72383105|NCT00943124|144274872|NON_INFERIORITY_OR_EQUIVALENCE|Power: If the true geometric mean ratio (GMR MK0524B/Simvastatin + MK0524A) is 1.00 for all the eight primary endpoints, then a sample size of N=220 subjects provides this study with greater than 99.2% probability of observing the 90% confidence intervals (CIs) of all the eight endpoints to be contained within \[0.80, 1.25\], assuming nonnegative associations among the 8 endpoints.|Least-Squares Mean Ratio|0.77||||||90.0|0.72|0.82||||||Least-Squares Mean Ratio (Fixed Dose Combination (FDC)/Co-administration)||0.82|0.72|
72383106|NCT00943124|144274873|NON_INFERIORITY_OR_EQUIVALENCE|Power: If the true geometric mean ratio (GMR MK0524B/Simvastatin + MK0524A) is 1.00 for all the eight primary endpoints, then a sample size of N=220 subjects provides this study with greater than 99.2% probability of observing the 90% confidence intervals (CIs) of all the eight endpoints to be contained within \[0.80, 1.25\], assuming nonnegative associations among the 8 endpoints.|Least-Squares Mean Ratio|0.92||||||90.0|0.89|0.94||||||Least-Squares Mean Ratio (Fixed Dose Combination (FDC)/Co-administration)||0.94|0.89|
72383107|NCT03194503|144274877|SUPERIORITY||Odds Ratio (OR)|0.65||||0.015|TWO_SIDED|95.0|0.47|0.92|||t-test, 2 sided|||This statistical analysis applies to all three rows in the post-intervention column. ITT analysis: Multivariable analysis for Any TIAEs, Severe TIAEs, and Severe desaturation(\>20%)||0.92|0.47|0.015
72383108|NCT03194503|144274878|SUPERIORITY||Odds Ratio (OR)|0.77||||0.25|TWO_SIDED|95.0|0.5|1.2|||t-test, 2 sided|||This statistical analysis applies to all three rows and is a per-protocol analysis: Multivariable analysis for Any TIAEs, Severe TIAEs, and Severe desaturation(\>20%)||1.20|0.50|0.250
72383109|NCT01916967|144274883|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS means|-1.17|||<|0.001|TWO_SIDED|95.0|-1.69|-0.65|||Constrained Longitudinal Data Analysis|Model with terms of visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable||Difference in least squares (LS) means of Desloratadine 5 mg and Placebo||-0.65|-1.69|<0.001
72383110|NCT01916967|144274883|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS means|-1.13|||<|0.001|TWO_SIDED|95.0|-1.66|-0.61|||Constrained Longitudinal Data Analysis|Model with terms of visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable||Difference in LS means of Desloratadine 10 mg and Placebo||-0.61|-1.66|<0.001
72383111|NCT00337350|144274894|SUPERIORITY_OR_OTHER|||||||0.08||95.0|||||ANCOVA|||||||0.08
72383112|NCT00337350|144274895|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||||||.05
72383113|NCT00337350|144274896|SUPERIORITY_OR_OTHER|||||||0.21||95.0|||||ANCOVA|||||||0.21
72504583|NCT01524289|144539966|SUPERIORITY||Difference in Least Squares (LS) Means|-39.7|||<|0.001|TWO_SIDED|95.0|-45.7|-33.7|||Constrained Longitudinal Data Analysis|Between group comparison of percent change from baseline performed using Constrained Longitudinal Data Analysis (cLDA) model.||||-33.7|-45.7|<0.001
72504584|NCT01524289|144539967|OTHER|Pre-specified|Difference in Percentages|-2.1|||||TWO_SIDED|95.0|-11.5|8.4|||||||Miettinen and Nurminen|8.4|-11.5|
72383114|NCT01302379|144274931|SUPERIORITY||Mean Difference (Final Values)|1.0|||<|0.05|TWO_SIDED|95.0|-97.5|97.5||No adjustment for multiple comparisons|Mixed Models Analysis|||||97.5|-97.5|<0.05
72383115|NCT00413400|144275009|SUPERIORITY_OR_OTHER|||||||0.2||95.0|||||ANCOVA|||treatment effect (etanercept vs. placebo) using ANCOVA including baseline CRP, age, and race||||0.20
72504585|NCT01524289|144539968|OTHER|Pre-specified|Difference in Percentages|4.5|||||TWO_SIDED|95.0|-4.8|12.6|||||||Miettinen and Nurminen|12.6|-4.8|
72383116|NCT00413400|144275010|SUPERIORITY_OR_OTHER|||||||0.92||95.0|||||Repeated Measures ANCOVA|||within subject percent changes calculated for each timepoint and repeated measures ANCOVA controlling for age and race performed||||0.92
72383117|NCT00413400|144275011|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||Repeated Measures ANCOVA|||within subject percent changes were calculated for each time point, then repeated measures ANCOVA controlling for age and race performed||||0.02
72383118|NCT00413400|144275012|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||repeated measures ANCOVA|||percent change calculated then repeated measures ANCOVA performed controlling for age and race||||0.02
72383119|NCT00413400|144275013|SUPERIORITY_OR_OTHER|||||||0.46||95.0|||||ANCOVA|||ANCOVA controlling for baseline value, age, race||||0.46
72383120|NCT00413400|144275014|SUPERIORITY_OR_OTHER|||||||0.78||95.0|||||t-test, 2 sided|||||||0.78
72383121|NCT00413400|144275015|SUPERIORITY_OR_OTHER|||||||0.11||95.0|||||t-test, 2 sided|||||||0.11
72383122|NCT00413400|144275016|SUPERIORITY_OR_OTHER|||||||0.59||95.0|||||ANCOVA|||ANCOVA controlling for baseline value, age, race||||0.59
72383123|NCT00413400|144275017|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Repeated measures ANCOVA|||within subject percent changes calculated then repeated measures ANCOVA controlling for age and race performed||||<0.0001
72383124|NCT00413400|144275018|SUPERIORITY_OR_OTHER|||||||0.08||95.0|||||Repeated Measures ANCOVA|||within subject percent changes calculated then repeated measures ANCOVA performed controlling for age and race||||0.08
72383125|NCT00413400|144275019|SUPERIORITY_OR_OTHER|||||||0.55||95.0|||||ANCOVA|||ANCOVA controlling for baseline value, age, and race||||0.55
72383126|NCT00891462|144275021|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.086|||<|0.0001|TWO_SIDED|95.0|0.05|0.13|||ANCOVA|||||0.13|0.05|<0.0001
72383127|NCT00891462|144275021|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.124|||<|0.0001|TWO_SIDED|95.0|0.08|0.16|||ANCOVA|||||0.16|0.08|<0.0001
72383128|NCT00257608|144275039|SUPERIORITY_OR_OTHER||Hazard Ratio, log|0.708||||0.0006|TWO_SIDED|95.0|0.58|0.864|||Log Rank|||||0.864|0.580|0.0006
72383129|NCT00257608|144275045|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.917||||0.5341|TWO_SIDED|95.0|0.698|1.205|||Log Rank|||||1.205|0.698|0.5341
72383130|NCT03347188|144275069|SUPERIORITY||LS Mean|1.5|STANDARD_ERROR_OF_MEAN|1.11||0.1876|TWO_SIDED|95.0|-0.73|3.67||Threshold for significance at 0.05 level.|ANCOVA|||||3.67|-0.73|0.1876
72383131|NCT00195273|144275084|SUPERIORITY_OR_OTHER|||||||0.6081||||||Calculated for 12 month analysis|ANOVA|Analysis of variance with treatment group and center as factors||||||0.6081
72383132|NCT00195273|144275087|SUPERIORITY_OR_OTHER|||||||0.4662|||||||ANOVA|Calculated for 3 month analysis||||||0.4662
72383133|NCT02186873|144275091|SUPERIORITY_OR_OTHER||Difference in Percentage|47.1|||<|0.001|TWO_SIDED|95.0|35.18|58.99|||Cochran-Mantel-Haenszel|||||58.99|35.18|<0.001
72383134|NCT02595970|144275103|SUPERIORITY|adjusted for multiplicity using the Hochberg procedure.|Mean Difference (Net)|-22.6|STANDARD_ERROR_OF_MEAN|0.99|<|0.0001|TWO_SIDED|95.0|-24.52|20.59|||t-test, 2 sided|||||20.59|-24.52|<0.0001
72435113|NCT00383188|144383175|SUPERIORITY||LSM Difference|-1.057|STANDARD_ERROR_OF_MEAN|0.331||0.0015|TWO_SIDED|95.0|-1.707|-0.407|||ANCOVA|||Week 1: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 1 as an interaction term, baseline Pain Intensity Domain of mBPI as the covariate; and participant as a random effect.||-0.407|-1.707|0.0015
72435114|NCT00383188|144383175|SUPERIORITY||LSM Difference|-1.107|STANDARD_ERROR_OF_MEAN|0.385||0.0042|TWO_SIDED|95.0|-1.863|-0.351|||ANCOVA|||Week 1: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 1 as an interaction term, baseline Pain Intensity Domain of mBPI as the covariate; and participant as a random effect.||-0.351|-1.863|0.0042
72435115|NCT00383188|144383175|SUPERIORITY||LSM Difference|-0.842|STANDARD_ERROR_OF_MEAN|0.398||0.0348|TWO_SIDED|95.0|-1.624|-0.06|||ANCOVA|||Week 1: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 1 as an interaction term, baseline Pain Intensity Domain of mBPI as the covariate; and participant as a random effect.||-0.060|-1.624|0.0348
72504586|NCT01524289|144539969|OTHER|Pre-specified|Difference in Percentages|-0.9|||||TWO_SIDED|95.0|-8.9|5.6|||||||Miettinen \& Nurminen|5.6|-8.9|
72557944|NCT00205777|144645468|SUPERIORITY_OR_OTHER|||||||0.41|TWO_SIDED||||||ANOVA|||||||0.41
72383135|NCT02595970|144275113|SUPERIORITY|adjusted|Mean Difference (Net)|-21.6|STANDARD_ERROR_OF_MEAN|0.99|<|0.0001|TWO_SIDED|95.0|-23.52|19.58|||t-test, 2 sided|||||19.58|-23.52|<0.0001
72383136|NCT01051466|144275120|SUPERIORITY_OR_OTHER|||||||0.457||95.0||||The significance level was 0.05 for a 2-sided test.|Mixed Models Analysis|||||||0.457
72383137|NCT01051466|144275121|SUPERIORITY_OR_OTHER|||||||0.627||||||The p-value is for change from baseline activation (BOLD response) in the anterior cingulate.|Mixed Models Analysis|||||||0.627
72383138|NCT01051466|144275121|SUPERIORITY_OR_OTHER|||||||0.338||||||The p-value is for change from baseline activation (BOLD response) in the left amygdala.|Mixed Models Analysis|||||||0.338
72383139|NCT01051466|144275121|SUPERIORITY_OR_OTHER|||||||0.518||||||The p-value is for change from baseline activation (BOLD response) in the right amygdala.|Mixed Models Analysis|||||||0.518
72383140|NCT01051466|144275122|SUPERIORITY_OR_OTHER|||||||0.03||||||The p-value is for change from baseline volume in the subgenual anterior cingulate.|Mixed Models Analysis|||||||0.030
72383141|NCT01051466|144275122|SUPERIORITY_OR_OTHER|||||||0.208||||||The p-value is for change from baseline volume in the left amygdalae.|Mixed Models Analysis|||||||0.208
72383142|NCT01051466|144275122|SUPERIORITY_OR_OTHER|||||||0.031||||||The p-value is for change from baseline volume in the right amygdalae.|Mixed Models Analysis|||||||0.031
72383143|NCT01051466|144275122|SUPERIORITY_OR_OTHER|||||||0.35||||||The p-value is for change from baseline volume in the left hippocampus.|Mixed Models Analysis|||||||0.350
72383144|NCT01051466|144275122|SUPERIORITY_OR_OTHER|||||||0.191||||||The p-value is for change from baseline volume in the right hippocampus.|Mixed Models Analysis|||||||0.191
72383145|NCT01051466|144275123|SUPERIORITY_OR_OTHER|||||||0.174||||||The p-value is for Gsα translocation in RBCs at Week 1.|Mixed Models Analysis|||||||0.174
72383146|NCT01051466|144275123|SUPERIORITY_OR_OTHER|||||||0.488||||||The p-value is for Gsα translocation in RBCs at Week 8.|Mixed Models Analysis|||||||0.488
72383147|NCT01051466|144275123|SUPERIORITY_OR_OTHER|||||||0.48||||||The p-value is for Gsα translocation in RBCs at Week 12.|Mixed Models Analysis|||||||0.480
72383148|NCT01051466|144275123|SUPERIORITY_OR_OTHER|||||||0.925||||||The p-value is for Gsα translocation in platelets at Week 1.|Mixed Models Analysis|||||||0.925
72383149|NCT01051466|144275123|SUPERIORITY_OR_OTHER|||||||0.697||||||The p-value is for Gsα translocation in platelets at Week 8.|Mixed Models Analysis|||||||0.697
72383150|NCT01051466|144275123|SUPERIORITY_OR_OTHER|||||||0.276||||||The p-value is for Gsα translocation in platelets at Week 12.|Mixed Models Analysis|||||||0.276
72383151|NCT01051466|144275125|SUPERIORITY_OR_OTHER|||||||0.904||||||The p-value is for change from baseline BDNF.|Mixed Models Analysis|||||||0.904
72383152|NCT01051466|144275125|SUPERIORITY_OR_OTHER|||||||0.819||||||The p-value is for change from baseline proBDNF.|Mixed Models Analysis|||||||0.819
72383153|NCT01051466|144275126|SUPERIORITY_OR_OTHER|||||||0.273||||||The p-value is for change from baseline trkB.|Mixed Models Analysis|||||||0.273
72383154|NCT01051466|144275127|SUPERIORITY_OR_OTHER|||||||0.797||||||The p-value is for change from baseline cytokine TNFα.|Mixed Models Analysis|||||||0.797
72383155|NCT01051466|144275127|SUPERIORITY_OR_OTHER|||||||0.269||||||The p-value is for change from baseline cytokine IL-1.|Mixed Models Analysis|||||||0.269
72383156|NCT01051466|144275127|SUPERIORITY_OR_OTHER|||||||0.925||||||The p-value is for change from baseline cytokine IL-6.|Mixed Models Analysis|||||||0.925
72383157|NCT00351000|144275172|SUPERIORITY_OR_OTHER|||||||0.956||95.0|||||t-test, 2 sided|||||||0.956
72383158|NCT00351000|144275173|SUPERIORITY_OR_OTHER|||||||0.988||95.0|||||t-test, 2 sided|||||||0.988
72383159|NCT05015530|144275176|SUPERIORITY|||||||0.908|||||||Kruskal-Wallis|||α-diversity assessed using the Kruskal-Wallis test||||0.908
72383160|NCT01539642|144275182|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|50.02|STANDARD_ERROR_OF_MEAN|15.25||0.001|TWO_SIDED|95.0|19.89|80.14|||ANCOVA|||||80.14|19.89|0.001
72383161|NCT00809354|144275212|SUPERIORITY_OR_OTHER_LEGACY||Least Square (LS) Mean Difference|-0.92|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|95.0|-1.28|-0.57|||ANCOVA|||Analysis was based on analysis of co-variance (ANCOVA) model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.57|-1.28|<0.001
72383162|NCT00809354|144275212|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|95.0|-1.06|-0.33|||ANCOVA|||Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.33|-1.06|<0.001
72383163|NCT00809354|144275212|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.58|STANDARD_ERROR_OF_MEAN|0.18||0.001|TWO_SIDED|95.0|-0.94|-0.23|||ANCOVA|||Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.23|-0.94|0.001
72383164|NCT00809354|144275212|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.45|STANDARD_ERROR_OF_MEAN|0.18||0.015|TWO_SIDED|95.0|-0.81|-0.09|||ANCOVA|||Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.09|-0.81|0.015
72383165|NCT00809354|144275212|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.18||0.453|TWO_SIDED|95.0|-0.49|0.22|||ANCOVA|||Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.22|-0.49|0.453
72383166|NCT00809354|144275212|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.25|STANDARD_ERROR_OF_MEAN|0.18||0.177|TWO_SIDED|95.0|-0.61|0.11|||ANCOVA|||Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.11|-0.61|0.177
72383167|NCT00809354|144275212|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.34|STANDARD_ERROR_OF_MEAN|0.18||0.062|TWO_SIDED|95.0|-0.7|0.02|||ANCOVA|||Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.02|-0.70|0.062
72383168|NCT00809354|144275212|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.23|STANDARD_ERROR_OF_MEAN|0.18||0.212|TWO_SIDED|95.0|-0.59|0.13|||ANCOVA|||Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.13|-0.59|0.212
72383169|NCT00809354|144275212|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.94|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|-1.34|-0.54|||ANCOVA|||Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.54|-1.34|<0.001
72383170|NCT00809354|144275212|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.75|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|-1.15|-0.35|||ANCOVA|||Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.35|-1.15|<0.001
72383171|NCT00809354|144275212|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.58|STANDARD_ERROR_OF_MEAN|0.2||0.004|TWO_SIDED|95.0|-0.98|-0.18|||ANCOVA|||Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.18|-0.98|0.004
72383172|NCT00809354|144275212|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.55|STANDARD_ERROR_OF_MEAN|0.2||0.007|TWO_SIDED|95.0|-0.95|-0.15|||ANCOVA|||Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.15|-0.95|0.007
72383173|NCT00809354|144275212|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.2||0.879|TWO_SIDED|95.0|-0.43|0.37|||ANCOVA|||Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.37|-0.43|0.879
72383174|NCT00809354|144275212|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.2||0.33|TWO_SIDED|95.0|-0.6|0.2|||ANCOVA|||Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.20|-0.60|0.330
72383175|NCT00809354|144275212|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.35|STANDARD_ERROR_OF_MEAN|0.2||0.083|TWO_SIDED|95.0|-0.75|0.05|||ANCOVA|||Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.05|-0.75|0.083
72383176|NCT00809354|144275212|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.2||0.36|TWO_SIDED|95.0|-0.59|0.21|||ANCOVA|||Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.21|-0.59|0.360
72383177|NCT00809354|144275213|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.88|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|95.0|-1.23|-0.53|||ANCOVA|||Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.53|-1.23|<0.001
72383178|NCT00809354|144275213|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.78|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|95.0|-1.13|-0.43|||ANCOVA|||Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.43|-1.13|<0.001
72383179|NCT00809354|144275213|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.52|STANDARD_ERROR_OF_MEAN|0.18||0.003|TWO_SIDED|95.0|-0.87|-0.17|||ANCOVA|||Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.17|-0.87|0.003
72383180|NCT00809354|144275213|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.48|STANDARD_ERROR_OF_MEAN|0.18||0.007|TWO_SIDED|95.0|-0.83|-0.13|||ANCOVA|||Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.13|-0.83|0.007
72383181|NCT00809354|144275213|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.18||0.824|TWO_SIDED|95.0|-0.39|0.31|||ANCOVA|||Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.31|-0.39|0.824
72383182|NCT00809354|144275213|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.29|STANDARD_ERROR_OF_MEAN|0.18||0.1|TWO_SIDED|95.0|-0.64|0.06|||ANCOVA|||Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.06|-0.64|0.100
72557945|NCT00205777|144645468|SUPERIORITY_OR_OTHER|||||||0.18||95.0|||||ANOVA|||||||0.18
72435116|NCT00383188|144383175|SUPERIORITY||LSM Difference|-0.442|STANDARD_ERROR_OF_MEAN|0.332||0.1843|TWO_SIDED|95.0|-1.095|0.211|||ANCOVA|||Week 2: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 2 as an interaction term, baseline Pain Intensity Domain of mBPI as the covariate; and participant as a random effect.||0.211|-1.095|0.1843
72435117|NCT00383188|144383175|SUPERIORITY||LSM Difference|-0.582|STANDARD_ERROR_OF_MEAN|0.327||0.076|TWO_SIDED|95.0|-1.225|0.061|||ANCOVA|||Week 2: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 2 as an interaction term, baseline Pain Intensity Domain of mBPI as the covariate; and participant as a random effect.||0.061|-1.225|0.0760
72435118|NCT00383188|144383175|SUPERIORITY||LSM Difference|-1.019|STANDARD_ERROR_OF_MEAN|0.382||0.0078|TWO_SIDED|95.0|-1.769|-0.27|||ANCOVA|||Week 2: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 2 as an interaction term, baseline Pain Intensity Domain of mBPI as the covariate; and participant as a random effect.||-0.270|-1.769|0.0078
72435119|NCT00383188|144383175|SUPERIORITY||LSM Difference|-0.517|STANDARD_ERROR_OF_MEAN|0.395||0.1905|TWO_SIDED|95.0|-1.292|0.258|||ANCOVA|||Week 2: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 2 as an interaction term, baseline Pain Intensity Domain of mBPI as the covariate; and participant as a random effect.||0.258|-1.292|0.1905
72435120|NCT00383188|144383175|SUPERIORITY||LSM Difference|-0.149|STANDARD_ERROR_OF_MEAN|0.332||0.6552|TWO_SIDED|95.0|-0.801|0.504|||ANCOVA|||Week 4: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 4 as an interaction term, baseline Pain Intensity Domain of mBPI as the covariate; and participant as a random effect.||0.504|-0.801|0.6552
72435121|NCT00383188|144383175|SUPERIORITY||LSM Difference|-0.72|STANDARD_ERROR_OF_MEAN|0.327||0.0281|TWO_SIDED|95.0|-1.363|-0.078|||ANCOVA|||Week 4: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 4 as an interaction term, baseline Pain Intensity Domain of mBPI as the covariate; and participant as a random effect.||-0.078|-1.363|0.0281
72435122|NCT00383188|144383175|SUPERIORITY||LSM Difference|-0.85|STANDARD_ERROR_OF_MEAN|0.382||0.0263|TWO_SIDED|95.0|-1.599|-0.1|||ANCOVA|||Week 4: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 4 as an interaction term, baseline Pain Intensity Domain of mBPI as the covariate; and participant as a random effect.||-0.100|-1.599|0.0263
72435123|NCT00383188|144383175|SUPERIORITY||LSM Difference|-0.429|STANDARD_ERROR_OF_MEAN|0.395||0.2772|TWO_SIDED|95.0|-1.204|0.346|||ANCOVA|||Week 4: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 4 as an interaction term, baseline Pain Intensity Domain of mBPI as the covariate; and participant as a random effect.||0.346|-1.204|0.2772
72435124|NCT00383188|144383175|SUPERIORITY||LSM Difference|-0.024|STANDARD_ERROR_OF_MEAN|0.332||0.9433|TWO_SIDED|95.0|-0.676|0.629|||ANCOVA|||Week 8: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 8 as an interaction term, baseline Pain Intensity Domain of mBPI as the covariate; and participant as a random effect.||0.629|-0.676|0.9433
72435125|NCT00383188|144383175|SUPERIORITY||LSM Difference|-0.768|STANDARD_ERROR_OF_MEAN|0.327||0.193|TWO_SIDED|95.0|-1.41|-0.125|||ANCOVA|||Week 8: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 8 as an interaction term, baseline Pain Intensity Domain of mBPI as the covariate; and participant as a random effect.||-0.125|-1.410|0.193
72435126|NCT00383188|144383175|SUPERIORITY||LSM Difference|-0.763|STANDARD_ERROR_OF_MEAN|0.382||0.461|TWO_SIDED|95.0|-1.512|-0.013|||ANCOVA|||Week 8: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 8 as an interaction term, baseline Pain Intensity Domain of mBPI as the covariate; and participant as a random effect.||-0.013|-1.512|0.461
72494198|NCT04418765|144517317|OTHER|Testing sequence: 1. Change in MMDs (Weeks 1-12) 300 mg vs placebo; 2. 50% responders for MMDs (Weeks 1-12) 300 mg vs placebo; 3. Change in MMDs (Weeks 1-12) 100 mg vs placebo; 4. 50% responders for MMDs (Weeks 1-12) 100 mg vs placebo; 5a. Change in MMDs (Weeks 13-24), 5b. 75% responders for MMDs (Weeks 1-12), 5c. Change in HIT-6 (Week 12) 300 mg vs placebo; 6a. Change in MMDs (Weeks 13-24), 6b. 75% responders for MMDs (Weeks 1-12), 6c. Change in HIT-6 (Week 12) 100 mg vs placebo.|Mean Difference (Final Values)|-3.8|STANDARD_ERROR_OF_MEAN|0.63|<|0.0001|TWO_SIDED|95.0|-5.0|-2.5||Threshold for significance: The consecutive order of the smallest (p1), the second smallest (p2), and the largest p-value (p3) had to be \<α/3, \<α/2, and \<α, where α = 0.05. Here it is test no. 6c of testing order.|Mixed Models Analysis|||"Analysis was performed using MMRM with the following fixed effects: visit, country, stratification factor (MHDs at baseline: ≤14/\>14) and treatment as factors, baseline HIT-6 Total Score as a continuous covariate, baseline score-by-visit interaction, treatment-by-visit interaction, and stratum-by-visit interaction.~A testing strategy (sequence of tests) was applied to ensure protection of the type 1 error.~Testing continued only, if the previous comparison was statistically significant."||-2.5|-5.0|<0.0001
72504587|NCT01524289|144539970|OTHER|Pre-specified|Difference in Percentages|1.0|||||TWO_SIDED|95.0|-5.5|6.1|||||||Miettinen and Nurminen|6.1|-5.5|
72435127|NCT00383188|144383175|SUPERIORITY||LSM Difference|-0.254|STANDARD_ERROR_OF_MEAN|0.395||0.52|TWO_SIDED|95.0|-1.029|0.521|||ANCOVA|||Week 8: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 8 as an interaction term, baseline Pain Intensity Domain of mBPI as the covariate; and participant as a random effect.||0.521|-1.029|0.5200
72435128|NCT00383188|144383175|SUPERIORITY||LSM Difference|-0.476|STANDARD_ERROR_OF_MEAN|0.332||0.1526|TWO_SIDED|95.0|-1.129|0.177|||ANCOVA|||Week 12: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 12 as an interaction term, baseline Pain Intensity Domain of mBPI as the covariate; and participant as a random effect.||0.177|-1.129|0.1526
72435129|NCT00383188|144383175|SUPERIORITY||LSM Difference|-1.095|STANDARD_ERROR_OF_MEAN|0.327||0.0009|TWO_SIDED|95.0|-1.738|-0.453|||ANCOVA|||Week 12: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 12 as an interaction term, baseline Pain Intensity Domain of mBPI as the covariate; and participant as a random effect.||-0.453|-1.738|0.0009
72557946|NCT00205777|144645469|SUPERIORITY_OR_OTHER|||||||0.97|TWO_SIDED||||||ANOVA|||||||0.97
72557947|NCT00205777|144645469|SUPERIORITY_OR_OTHER|||||||0.61||95.0|||||ANOVA|||||||0.61
72557948|NCT00205777|144645469|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANOVA|||||||0.050
72557949|NCT00205777|144645469|SUPERIORITY_OR_OTHER|||||||0.061||95.0|||||ANOVA|||||||0.061
72494199|NCT01121393|144517354|SUPERIORITY||||||<|0.0001|TWO_SIDED||||||Log Rank|||A stratified log-rank test (by the epidermal growth factor receptor (EGFR) mutation category stratification factor used at randomisation) was used to test for the effect of afatinib on PFS compared with gemcitabine / cisplatin chemotherapy.||||<0.0001
72494200|NCT01121393|144517354|SUPERIORITY||Hazard Ratio (HR)|0.281|||||TWO_SIDED|95.0|0.203|0.389||||||A Cox proportional-hazards model, stratified by EGFR mutation category was used to estimate the hazard ratio (HR) and 95% confidence interval (CI) between the 2 treatment arms.||0.389|0.203|
72435130|NCT00383188|144383175|SUPERIORITY||LSM Difference|-0.523|STANDARD_ERROR_OF_MEAN|0.382||0.1711|TWO_SIDED|95.0|-1.273|0.227|||ANCOVA|||Week 12: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 12 as an interaction term, baseline Pain Intensity Domain of mBPI as the covariate; and participant as a random effect.||0.227|-1.273|0.1711
72435131|NCT00383188|144383175|SUPERIORITY||LSM Difference|-0.563|STANDARD_ERROR_OF_MEAN|0.395||0.1539|TWO_SIDED|95.0|-1.338|0.211|||ANCOVA|||Week 12: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 12 as an interaction term, baseline Pain Intensity Domain of mBPI as the covariate; and participant as a random effect.||0.211|-1.338|0.1539
72435132|NCT00383188|144383175|SUPERIORITY||LSM Difference|-0.512|STANDARD_ERROR_OF_MEAN|0.36||0.1554|TWO_SIDED|95.0|-1.219|0.195|||ANCOVA|||Week 1: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 1 as an interaction term, baseline Pain Interference Domain of mBPI as the covariate; and participant as a random effect.||0.195|-1.219|0.1554
72435133|NCT00383188|144383175|SUPERIORITY||LSM Difference|-0.889|STANDARD_ERROR_OF_MEAN|0.354||0.0124|TWO_SIDED|95.0|-1.585|-0.193|||ANCOVA|||Week 1: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 1 as an interaction term, baseline Pain Interference Domain of mBPI as the covariate; and participant as a random effect.||-0.193|-1.585|0.0124
72435134|NCT00383188|144383175|SUPERIORITY||LSM Difference|-0.914|STANDARD_ERROR_OF_MEAN|0.412||0.0268|TWO_SIDED|95.0|-1.723|-0.106|||ANCOVA|||Week 1: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 1 as an interaction term, baseline Pain Interference Domain of mBPI as the covariate; and participant as a random effect.||-0.106|-1.723|0.0268
72494201|NCT01121393|144517355|SUPERIORITY||Odds Ratio (OR)|7.572|||<|0.0001|TWO_SIDED|95.0|4.522|12.679|||Regression, Logistic|||A logistic regression model, stratified by EGFR mutation category was used to compare the objective response rate between the 2 treatment arms.||12.679|4.522|<0.0001
72494202|NCT01121393|144517356|SUPERIORITY||Odds Ratio (OR)|3.843|||<|0.0001|TWO_SIDED|95.0|2.039|7.24|||Regression, Logistic|||stratified for EGFR mutation group||7.240|2.039|<0.0001
72494203|NCT01121393|144517357|SUPERIORITY|||||||0.4013|TWO_SIDED||||||Log Rank|||A stratified log-rank test (by the epidermal growth factor receptor (EGFR) mutation category stratification factor used at randomisation) was used to test for the effect of afatinib on OS compared with gemcitabine / cisplatin chemotherapy.||||0.4013
72504588|NCT01524289|144539971|OTHER|Pre-Specified|Difference in Percentages|-8.4||||0.168|TWO_SIDED|95.0|-20.1|3.5|||Miettinen and Nurminen|||||3.5|-20.1|0.168
72504589|NCT01524289|144539972|OTHER|Pre-specified|Difference in Percentages|-7.4||||0.179|TWO_SIDED|95.0|-18.7|3.3|||Miettinen and Nurminen|||||3.3|-18.7|0.179
72504590|NCT01524289|144539973|OTHER|Pre-specified|Difference in Percentages|-13.9||||0.011|TWO_SIDED|95.0|-25.0|-3.1|||Miettinen and Nurminen|||||-3.1|-25.0|0.011
72504591|NCT01524289|144539974|OTHER|Pre-specified|Difference in Percentages|1.5||||0.696|TWO_SIDED|95.0|-6.8|8.4|||Miettinen and Nurminen|||||8.4|-6.8|0.696
72504592|NCT01524289|144539975|OTHER|Pre-specified|Difference in Percentages|0.5||||0.48|TWO_SIDED|95.0|-3.2|2.8|||Miettinen and Nurminen|||||2.8|-3.2|0.480
72504593|NCT01524289|144539976|OTHER|Pre-specified|Difference in Percentages|0.5||||0.722|TWO_SIDED|95.0|-4.0|3.5|||Miettinen and Nurminen|||||3.5|-4.0|0.722
72504594|NCT01524289|144539977|OTHER|Pre-specified|Difference in Percentages|0.0|||>|0.999|TWO_SIDED|95.0|-3.7|1.9|||Miettinen and Nurminen|||||1.9|-3.7|>0.999
72504595|NCT01524289|144539978|OTHER|Pre-specified|Difference in Percentages|0.5||||0.722|TWO_SIDED|95.0|-4.0|3.5|||Miettinen and Nurminen|||||3.5|-4.0|0.722
72504596|NCT01524289|144539979|OTHER|Pre-specified|Difference in Percentages|-1.0||||0.157|TWO_SIDED|95.0|-5.4|0.9|||Miettinen and Nurminen|||||0.9|-5.4|0.157
72504597|NCT01524289|144539980|OTHER|Pre-specified|Difference in Percentages|-1.0||||0.157|TWO_SIDED|95.0|-5.4|0.9|||Miettinen and Nurminen|||||0.9|-5.4|0.157
72504598|NCT01524289|144539981|OTHER|Pre-specified|Difference in Percentages|1.5||||0.218|TWO_SIDED|95.0|-2.2|4.3|||Miettinen and Nurminen|||||4.3|-2.2|0.218
72504599|NCT01524289|144539982|OTHER|Pre-specified|Difference in Percentages|0.0|||>|0.999|TWO_SIDED|95.0|-3.6|1.9|||Miettinen and Nurminen|||||1.9|-3.6|>0.999
72504600|NCT01524289|144539983|SUPERIORITY||Difference in Least Squares (LS) Means|102.1|||<|0.001|TWO_SIDED|95.0|94.2|110.1|||Constrained Longitudinal Data Analysis|||||110.1|94.2|<0.001
72504601|NCT01524289|144539984|SUPERIORITY||Difference in LS Means|-36.4|||<|0.001|TWO_SIDED|95.0|-41.7|-31.1|||Constrained Longitudinal Data Analysis|||||-31.1|-41.7|<0.001
72504602|NCT01524289|144539985|SUPERIORITY||Difference in LS Means|-24.8|||<|0.001|TWO_SIDED|95.0|-29.5|-20.1|||Constrained Longitudinal Data Analysis|||||-20.1|-29.5|<0.001
72557950|NCT00205777|144645469|SUPERIORITY_OR_OTHER|||||||0.14||95.0|||||ANOVA|||||||0.14
72383183|NCT00809354|144275213|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.36|STANDARD_ERROR_OF_MEAN|0.18||0.044|TWO_SIDED|95.0|-0.7|-0.01|||ANCOVA|||Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.01|-0.70|0.044
72383184|NCT00809354|144275213|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.18||0.565|TWO_SIDED|95.0|-0.45|0.25|||ANCOVA|||Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.25|-0.45|0.565
72383185|NCT00809354|144275213|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.01|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|-1.4|-0.62|||ANCOVA|||Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.62|-1.40|<0.001
72383186|NCT00809354|144275213|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.81|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|-1.2|-0.42|||ANCOVA|||Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.42|-1.20|<0.001
72383187|NCT00809354|144275213|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.63|STANDARD_ERROR_OF_MEAN|0.2||0.002|TWO_SIDED|95.0|-1.02|-0.24|||ANCOVA|||Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.24|-1.02|0.002
72383188|NCT00809354|144275213|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.63|STANDARD_ERROR_OF_MEAN|0.2||0.002|TWO_SIDED|95.0|-1.02|-0.24|||ANCOVA|||Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.24|-1.02|0.002
72383189|NCT00809354|144275213|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.2||0.98|TWO_SIDED|95.0|-0.39|0.4|||ANCOVA|||Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.40|-0.39|0.980
72383190|NCT00809354|144275213|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.2||0.383|TWO_SIDED|95.0|-0.56|0.22|||ANCOVA|||Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.22|-0.56|0.383
72383191|NCT00809354|144275213|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.38|STANDARD_ERROR_OF_MEAN|0.2||0.057|TWO_SIDED|95.0|-0.77|0.01|||ANCOVA|||Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.01|-0.77|0.057
72383192|NCT00809354|144275213|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.2||0.312|TWO_SIDED|95.0|-0.59|0.19|||ANCOVA|||Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.19|-0.59|0.312
72383193|NCT00809354|144275214|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.07||0.008|TWO_SIDED|95.0|-0.32|-0.05|||ANCOVA|||Analysis was based on analysis of co-variance (ANCOVA) model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.05|-0.32|0.008
72383194|NCT00809354|144275214|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.07||0.251|TWO_SIDED|95.0|-0.22|0.06|||ANCOVA|||Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.06|-0.22|0.251
72383195|NCT00809354|144275214|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.07||0.251|TWO_SIDED|95.0|-0.22|0.06|||ANCOVA|||Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.06|-0.22|0.251
72383196|NCT00809354|144275214|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.07||0.961|TWO_SIDED|95.0|-0.14|0.13|||ANCOVA|||Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.13|-0.14|0.961
72383197|NCT00809354|144275214|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.07||0.272|TWO_SIDED|95.0|-0.21|0.06|||ANCOVA|||Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.06|-0.21|0.272
72383198|NCT00809354|144275214|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.07||0.271|TWO_SIDED|95.0|-0.21|0.06|||ANCOVA|||Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.06|-0.21|0.271
72435135|NCT00383188|144383175|SUPERIORITY||LSM Difference|-0.681|STANDARD_ERROR_OF_MEAN|0.427||0.1113|TWO_SIDED|95.0|-1.519|0.158|||ANCOVA|||Week 1: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 1 as an interaction term, baseline Pain Interference Domain of mBPI as the covariate; and participant as a random effect.||0.158|-1.519|0.1113
72435136|NCT00383188|144383175|SUPERIORITY||LSM Difference|-0.54|STANDARD_ERROR_OF_MEAN|0.356||0.1305|TWO_SIDED|95.0|-1.24|0.16|||ANCOVA|||Week 2: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 2 as an interaction term, baseline Pain Interference Domain of mBPI as the covariate; and participant as a random effect.||0.160|-1.240|0.1305
72435137|NCT00383188|144383175|SUPERIORITY||LSM Difference|-0.571|STANDARD_ERROR_OF_MEAN|0.351||0.1043|TWO_SIDED|95.0|-1.261|0.118|||ANCOVA|||Week 2: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 2 as an interaction term, baseline Pain Interference Domain of mBPI as the covariate; and participant as a random effect.||0.118|-1.261|0.1043
72435138|NCT00383188|144383175|SUPERIORITY||LSM Difference|-1.017|STANDARD_ERROR_OF_MEAN|0.409||0.0131|TWO_SIDED|95.0|-1.82|-0.214|||ANCOVA|||Week 2: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 2 as an interaction term, baseline Pain Interference Domain of mBPI as the covariate; and participant as a random effect.||-0.214|-1.820|0.0131
72435139|NCT00383188|144383175|SUPERIORITY||LSM Difference|-0.492|STANDARD_ERROR_OF_MEAN|0.424||0.2459|TWO_SIDED|95.0|-1.324|0.34|||ANCOVA|||Week 2: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 2 as an interaction term, baseline Pain Interference Domain of mBPI as the covariate; and participant as a random effect.||0.340|-1.324|0.2459
72557951|NCT00205777|144645470|SUPERIORITY_OR_OTHER|||||||0.15|TWO_SIDED||||||ANOVA|||||||0.15
72557952|NCT00205777|144645470|SUPERIORITY_OR_OTHER|||||||0.056||95.0|||||ANOVA|||||||0.056
72557953|NCT00205777|144645472|SUPERIORITY_OR_OTHER|||||||0.2|TWO_SIDED||||||ANOVA|||Change at Month 12 in WHQ: P value was calculated using ANOVA.||||0.20
72435140|NCT00383188|144383175|SUPERIORITY||LSM Difference|-0.221|STANDARD_ERROR_OF_MEAN|0.356||0.536|TWO_SIDED|95.0|-0.921|0.479|||ANCOVA|||Week 4: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 4 as an interaction term, baseline Pain Interference Domain of mBPI as the covariate; and participant as a random effect.||0.479|-0.921|0.5360
72435141|NCT00383188|144383175|SUPERIORITY||LSM Difference|-0.465|STANDARD_ERROR_OF_MEAN|0.351||0.1858|TWO_SIDED|95.0|-1.155|0.225|||ANCOVA|||Week 4: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 4 as an interaction term, baseline Pain Interference Domain of mBPI as the covariate; and participant as a random effect.||0.225|-1.155|0.1858
72435142|NCT00383188|144383175|SUPERIORITY||LSM Difference|-0.821|STANDARD_ERROR_OF_MEAN|0.409||0.0451|TWO_SIDED|95.0|-1.624|-0.018|||ANCOVA|||Week 4: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 4 as an interaction term, baseline Pain Interference Domain of mBPI as the covariate; and participant as a random effect.||-0.018|-1.624|0.0451
72435143|NCT00383188|144383175|SUPERIORITY||LSM Difference|-0.189|STANDARD_ERROR_OF_MEAN|0.424||0.6551|TWO_SIDED|95.0|-1.021|0.643|||ANCOVA|||Week 4: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 4 as an interaction term, baseline Pain Interference Domain of mBPI as the covariate; and participant as a random effect.||0.643|-1.021|0.6551
72435144|NCT00383188|144383175|SUPERIORITY||LSM Difference|0.018|STANDARD_ERROR_OF_MEAN|0.356||0.9602|TWO_SIDED|95.0|-0.682|0.718|||ANCOVA|||Week 8: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 8 as an interaction term, baseline Pain Interference Domain of mBPI as the covariate; and participant as a random effect.||0.718|-0.682|0.9602
72435145|NCT00383188|144383175|SUPERIORITY||LSM Difference|-0.82|STANDARD_ERROR_OF_MEAN|0.351||0.0198|TWO_SIDED|95.0|-1.51|-0.131|||ANCOVA|||Week 8: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 8 as an interaction term, baseline Pain Interference Domain of mBPI as the covariate; and participant as a random effect.||-0.131|-1.510|0.0198
72435146|NCT00383188|144383175|SUPERIORITY||LSM Difference|-0.948|STANDARD_ERROR_OF_MEAN|0.409||0.0208|TWO_SIDED|95.0|-1.751|-0.145|||ANCOVA|||Week 8: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 8 as an interaction term, baseline Pain Interference Domain of mBPI as the covariate; and participant as a random effect.||-0.145|-1.751|0.0208
72435147|NCT00383188|144383175|SUPERIORITY||LSM Difference|-0.433|STANDARD_ERROR_OF_MEAN|0.424||0.3077|TWO_SIDED|95.0|-1.265|0.4|||ANCOVA|||Week 8: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 8 as an interaction term, baseline Pain Interference Domain of mBPI as the covariate; and participant as a random effect.||0.400|-1.265|0.3077
72435148|NCT00383188|144383175|SUPERIORITY||LSM Difference|-0.211|STANDARD_ERROR_OF_MEAN|0.356||0.555|TWO_SIDED|95.0|-0.911|0.49|||ANCOVA|||Week 12: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 12 as an interaction term, baseline Pain Interference Domain of mBPI as the covariate; and participant as a random effect.||0.490|-0.911|0.5550
72435149|NCT00383188|144383175|SUPERIORITY||LSM Difference|-0.795|STANDARD_ERROR_OF_MEAN|0.351||0.0239|TWO_SIDED|95.0|-1.485|-0.106|||ANCOVA|||Week 12: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 12 as an interaction term, baseline Pain Interference Domain of mBPI as the covariate; and participant as a random effect.||-0.106|-1.485|0.0239
72435150|NCT00383188|144383175|SUPERIORITY||LSM Difference|-0.613|STANDARD_ERROR_OF_MEAN|0.409||0.1342|TWO_SIDED|95.0|-1.416|0.19|||ANCOVA|||Week 12: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 12 as an interaction term, baseline Pain Interference Domain of mBPI as the covariate; and participant as a random effect.||0.190|-1.416|0.1342
72494204|NCT01121393|144517357|SUPERIORITY||Hazard Ratio (HR)|0.904|||||TWO_SIDED|95.0|0.715|1.144||||||A Cox proportional hazard model stratified (by EGFR mutation category stratification factor used at randomisation) was used to test the effect of afatinib on OS compared with gemcitabine / cisplatin chemotherapy.||1.144|0.715|
72494205|NCT01121393|144517361|SUPERIORITY||Mean Difference (Final Values)|-13.64|STANDARD_ERROR_OF_MEAN|1.76|<|0.0001|TWO_SIDED|95.0|-17.1|-10.19|||ANCOVA|adjusted for baseline sum of diameters and EGFR mutation group||||-10.19|-17.10|<0.0001
72435151|NCT00383188|144383175|SUPERIORITY||LSM Difference|-0.367|STANDARD_ERROR_OF_MEAN|0.424||0.3868|TWO_SIDED|95.0|-1.199|0.465|||ANCOVA|||Week 12: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 12 as an interaction term, baseline Pain Interference Domain of mBPI as the covariate; and participant as a random effect.||0.465|-1.199|0.3868
72435152|NCT00383188|144383176|SUPERIORITY||LSM Difference|0.792|STANDARD_ERROR_OF_MEAN|1.093||0.4693|TWO_SIDED|95.0|-1.357|2.941|||ANCOVA|||Week 4: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 4 as an interaction term, baseline SF-36 PCS as the covariate; and participant as a random effect.||2.941|-1.357|0.4693
72435153|NCT00383188|144383176|SUPERIORITY||LSM Difference|1.927|STANDARD_ERROR_OF_MEAN|1.077||0.0743|TWO_SIDED|95.0|-0.19|4.044|||ANCOVA|||Week 4: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 4 as an interaction term, baseline SF-36 PCS as the covariate; and participant as a random effect.||4.044|-0.190|0.0743
72435154|NCT00383188|144383176|SUPERIORITY||LSM Difference|4.196|STANDARD_ERROR_OF_MEAN|1.286||0.0012|TWO_SIDED|95.0|1.668|6.723|||ANCOVA|||Week 4: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 4 as an interaction term, baseline SF-36 PCS as the covariate; and participant as a random effect.||6.723|1.668|0.0012
72494206|NCT01121393|144517364|SUPERIORITY|||||||0.0001|TWO_SIDED||||||Log Rank|||A stratified log-rank test (by the epidermal growth factor receptor (EGFR) mutation category stratification factor used at randomisation) was used to test for the effect of afatinib on HRQOL compared with gemcitabine / cisplatin chemotherapy.||||0.0001
72494207|NCT01121393|144517364|SUPERIORITY||Hazard Ratio (HR)|0.458|||||TWO_SIDED|95.0|0.303|0.692||||||Cox proportional hazard model stratified by EGFR mutation group||0.692|0.303|
72383199|NCT00809354|144275214|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.07||0.128|TWO_SIDED|95.0|-0.24|0.03|||ANCOVA|||Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.03|-0.24|0.128
72494208|NCT01121393|144517365|SUPERIORITY||||||<|0.0001|TWO_SIDED||||||Log Rank|||A stratified log-rank test (by the epidermal growth factor receptor (EGFR) mutation category stratification factor used at randomisation) was used to test for the effect of afatinib on HRQOL compared with gemcitabine / cisplatin chemotherapy.||||<0.0001
72494209|NCT01121393|144517365|SUPERIORITY||Hazard Ratio (HR)|0.534|||||TWO_SIDED|95.0|0.394|0.724||||||Cox proportional hazard model stratified by EGFR mutation group||0.724|0.394|
72494210|NCT01121393|144517366|SUPERIORITY|||||||0.022|TWO_SIDED||||||Log Rank|||A stratified log-rank test (by the epidermal growth factor receptor (EGFR) mutation category stratification factor used at randomisation) was used to test for the effect of afatinib on HRQOL compared with gemcitabine / cisplatin chemotherapy.||||0.0220
72494211|NCT01121393|144517366|SUPERIORITY||Hazard Ratio (HR)|0.699|||||TWO_SIDED|95.0|0.511|0.956||||||Cox proportional hazard model stratified by EGFR mutation group||0.956|0.511|
72383200|NCT00809354|144275214|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.07||0.133|TWO_SIDED|95.0|-0.24|0.03|||ANCOVA|||Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.03|-0.24|0.133
72383201|NCT00809354|144275214|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.21|STANDARD_ERROR_OF_MEAN|0.07||0.002|TWO_SIDED|95.0|-0.35|-0.08|||ANCOVA|||Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.08|-0.35|0.002
72383202|NCT00809354|144275214|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.07||0.004|TWO_SIDED|95.0|-0.34|-0.06|||ANCOVA|||Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.06|-0.34|0.004
72383203|NCT00809354|144275214|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.07||0.414|TWO_SIDED|95.0|-0.2|0.08|||ANCOVA|||Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.08|-0.20|0.414
72383204|NCT00809354|144275214|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.07||0.057|TWO_SIDED|95.0|-0.27|0.0|||ANCOVA|||Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.00|-0.27|0.057
72383205|NCT00809354|144275214|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.08|STANDARD_ERROR_OF_MEAN|0.07||0.277|TWO_SIDED|95.0|-0.06|0.21|||ANCOVA|||Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.21|-0.06|0.277
72383206|NCT00809354|144275214|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.07||0.328|TWO_SIDED|95.0|-0.21|0.07|||ANCOVA|||Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.07|-0.21|0.328
72383207|NCT00809354|144275214|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.07||0.026|TWO_SIDED|95.0|-0.3|-0.02|||ANCOVA|||Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.02|-0.30|0.026
72383208|NCT00809354|144275214|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.07||0.864|TWO_SIDED|95.0|-0.15|0.13|||ANCOVA|||Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.13|-0.15|0.864
72383209|NCT00809354|144275215|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.16||0.927|TWO_SIDED|95.0|-0.31|0.34|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.34|-0.31|0.927
72383210|NCT00809354|144275215|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.31|STANDARD_ERROR_OF_MEAN|0.17||0.057|TWO_SIDED|95.0|-0.64|0.01|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.01|-0.64|0.057
72383211|NCT00809354|144275215|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.16||0.779|TWO_SIDED|95.0|-0.37|0.28|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.28|-0.37|0.779
72383212|NCT00809354|144275215|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.16||0.798|TWO_SIDED|95.0|-0.36|0.28|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.28|-0.36|0.798
72383213|NCT00809354|144275215|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.16||0.98|TWO_SIDED|95.0|-0.33|0.32|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.32|-0.33|0.980
72494212|NCT01100944|144517381|SUPERIORITY_OR_OTHER|||||||0.021|||||||Wilcoxon (Mann-Whitney)|||||||0.021
72494213|NCT01100944|144517390|SUPERIORITY_OR_OTHER|||||||0.3||||||Fold change at Cycle 2 Day 1 vs. pre was assessed. Only differences with p\<0.005 could be potentially considered statistically significant while those with 0.005\<p\<0.05 would represent trends towards a difference.|Wilcoxon signed rank test|||||||0.30
72494214|NCT01100944|144517390|SUPERIORITY_OR_OTHER|||||||0.0001||||||Fold change at Cycle 1 Day 2 vs. pre was assessed. p values calculated were done using a Wilcoxon signed rank test relative to a ratio of 1.|Wilcoxon signed rank test|||||||0.0001
72494215|NCT01100944|144517390|SUPERIORITY_OR_OTHER|||||||0.0001||||||Fold change at Cycle 1 Day 3 vs. pre was assessed. p values calculated were done using a Wilcoxon signed rank test relative to a ratio of 1.|Wilcoxon signed rank test|||||||0.0001
72494216|NCT01100944|144517391|SUPERIORITY_OR_OTHER|||||||0.76||||||Fold change at Cycle 2 Day 1 vs. pre was assessed.Only differences with p\<0.005 could be potentially considered statistically significant while those with 0.005\<p\<0.05 would represent trends towards a difference.|Wilcoxon signed rank test|||||||0.76
72494217|NCT01100944|144517391|SUPERIORITY_OR_OTHER|||||||0.0009||||||Fold change at Cycle 1 Day 2 vs. pre was assessed. p values calculated were done using a Wilcoxon signed rank test relative to a ratio of 1.|Wilcoxon signed rank test|||||||0.0009
72494218|NCT01100944|144517391|SUPERIORITY_OR_OTHER|||||||0.0001||||||Fold change at Cycle 1 Day 3 vs. pre was assessed. p values calculated were done using a Wilcoxon signed rank test relative to a ratio of 1.|Wilcoxon signed rank test|||||||0.0001
72494219|NCT01100944|144517392|SUPERIORITY_OR_OTHER|||||||0.95||||||Fold change at Cycle 2 Day 1 vs. pre was assessed. p values calculated were done using a Wilcoxon signed rank test relative to a ratio of 1.|Wilcoxon signed rank test|||||||0.95
72383214|NCT00809354|144275215|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.27|STANDARD_ERROR_OF_MEAN|0.16||0.098|TWO_SIDED|95.0|-0.6|0.05|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.05|-0.60|0.098
72383215|NCT00809354|144275215|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.06|STANDARD_ERROR_OF_MEAN|0.16||0.709|TWO_SIDED|95.0|-0.26|0.38|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.38|-0.26|0.709
72383216|NCT00809354|144275215|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.33|STANDARD_ERROR_OF_MEAN|0.16||0.045|TWO_SIDED|95.0|0.01|0.65|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.65|0.01|0.045
72383217|NCT00809354|144275215|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.06|STANDARD_ERROR_OF_MEAN|0.17||0.71|TWO_SIDED|95.0|-0.28|0.41|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.41|-0.28|0.710
72383218|NCT00809354|144275215|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.17||0.504|TWO_SIDED|95.0|-0.46|0.23|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.23|-0.46|0.504
72383219|NCT00809354|144275215|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.23|STANDARD_ERROR_OF_MEAN|0.17||0.183|TWO_SIDED|95.0|-0.11|0.58|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.58|-0.11|0.183
72435155|NCT00383188|144383176|SUPERIORITY||LSM Difference|1.236|STANDARD_ERROR_OF_MEAN|1.308||0.3452|TWO_SIDED|95.0|-1.335|3.807|||ANCOVA|||Week 4: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 4 as an interaction term, baseline SF-36 PCS as the covariate; and participant as a random effect.||3.807|-1.335|0.3452
72435156|NCT00383188|144383176|SUPERIORITY||LSM Difference|1.095|STANDARD_ERROR_OF_MEAN|1.091||0.3162|TWO_SIDED|95.0|-1.05|3.239|||ANCOVA|||Week 12: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 12 as an interaction term, baseline SF-36 PCS as the covariate; and participant as a random effect.||3.239|-1.050|0.3162
72435157|NCT00383188|144383176|SUPERIORITY||LSM Difference|2.514|STANDARD_ERROR_OF_MEAN|1.072||0.0195|TWO_SIDED|95.0|0.406|4.622|||ANCOVA|||Week 12: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 12 as an interaction term, baseline SF-36 PCS as the covariate; and participant as a random effect.||4.622|0.406|0.0195
72494220|NCT01100944|144517392|SUPERIORITY_OR_OTHER|||||||0.0001||||||Fold change at Cycle 1 Day 2 vs. pre was assessed. p values calculated were done using a Wilcoxon signed rank test relative to a ratio of 1.|Wilcoxon signed rank test|||||||0.0001
72383220|NCT00809354|144275215|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.17||0.919|TWO_SIDED|95.0|-0.36|0.33|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.33|-0.36|0.919
72383221|NCT00809354|144275215|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.25|STANDARD_ERROR_OF_MEAN|0.17||0.152|TWO_SIDED|95.0|-0.09|0.59|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.59|-0.09|0.152
72383222|NCT00809354|144275215|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.17||0.572|TWO_SIDED|95.0|-0.44|0.24|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.24|-0.44|0.572
72383223|NCT00809354|144275215|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.17||0.337|TWO_SIDED|95.0|-0.51|0.18|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.18|-0.51|0.337
72383224|NCT00809354|144275215|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.18|STANDARD_ERROR_OF_MEAN|0.17||0.299|TWO_SIDED|95.0|-0.16|0.52|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.52|-0.16|0.299
72383225|NCT00809354|144275215|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.84|STANDARD_ERROR_OF_MEAN|0.17|<|0.001|TWO_SIDED|95.0|-1.17|-0.5|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.50|-1.17|<0.001
72383226|NCT00809354|144275215|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.89|STANDARD_ERROR_OF_MEAN|0.17|<|0.001|TWO_SIDED|95.0|-1.22|-0.55|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.55|-1.22|<0.001
72383227|NCT00809354|144275215|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.68|STANDARD_ERROR_OF_MEAN|0.17|<|0.001|TWO_SIDED|95.0|-1.01|-0.34|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.34|-1.01|<0.001
72383228|NCT00809354|144275215|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.52|STANDARD_ERROR_OF_MEAN|0.17||0.003|TWO_SIDED|95.0|-0.85|-0.18|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.18|-0.85|0.003
72383229|NCT00809354|144275215|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.17||0.341|TWO_SIDED|95.0|-0.5|0.17|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.17|-0.50|0.341
72435158|NCT00383188|144383176|SUPERIORITY||LSM Difference|2.762|STANDARD_ERROR_OF_MEAN|1.283||0.032|TWO_SIDED|95.0|0.239|5.285|||ANCOVA|||Week 12: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 12 as an interaction term, baseline SF-36 PCS as the covariate; and participant as a random effect.||5.285|0.239|0.0320
72435159|NCT00383188|144383176|SUPERIORITY||LSM Difference|0.268|STANDARD_ERROR_OF_MEAN|1.29||0.8356|TWO_SIDED|95.0|-2.268|2.804|||ANCOVA|||Week 12: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 12 as an interaction term, baseline SF-36 PCS as the covariate; and participant as a random effect.||2.804|-2.268|0.8356
72504603|NCT01524289|144539986|SUPERIORITY||Difference in LS Means|32.9|||<|0.001|TWO_SIDED|95.0|28.2|37.6|||Constrained Longitudinal Data Analysis|||||37.6|28.2|<0.001
72435160|NCT00383188|144383176|SUPERIORITY||LSM Difference|-0.904|STANDARD_ERROR_OF_MEAN|1.626||0.5787|TWO_SIDED|95.0|-4.101|2.293|||ANCOVA|||Week 4: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 4 as an interaction term, baseline SF-36 MCS as the covariate; and participant as a random effect.||2.293|-4.101|0.5787
72435161|NCT00383188|144383176|SUPERIORITY||LSM Difference|1.291|STANDARD_ERROR_OF_MEAN|1.6||0.4203|TWO_SIDED|95.0|-1.854|4.436|||ANCOVA|||Week 4: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 4 as an interaction term, baseline SF-36 MCS as the covariate; and participant as a random effect.||4.436|-1.854|0.4203
72435162|NCT00383188|144383176|SUPERIORITY||LSM Difference|2.318|STANDARD_ERROR_OF_MEAN|1.916||0.2272|TWO_SIDED|95.0|-1.449|6.084|||ANCOVA|||Week 4: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 4 as an interaction term, baseline SF-36 MCS as the covariate; and participant as a random effect.||6.084|-1.449|0.2272
72435163|NCT00383188|144383176|SUPERIORITY||LSM Difference|0.829|STANDARD_ERROR_OF_MEAN|1.947||0.6707|TWO_SIDED|95.0|-2.998|4.655|||ANCOVA|||Week 4: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 4 as an interaction term, baseline SF-36 MCS as the covariate; and participant as a random effect.||4.655|-2.998|0.6707
72435164|NCT00383188|144383176|SUPERIORITY||LSM Difference|0.425|STANDARD_ERROR_OF_MEAN|1.622||0.7935|TWO_SIDED|95.0|-2.764|3.613|||ANCOVA|||Week 12: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 12 as an interaction term, baseline SF-36 MCS as the covariate; and participant as a random effect.||3.613|-2.764|0.7935
72435165|NCT00383188|144383176|SUPERIORITY||LSM Difference|2.525|STANDARD_ERROR_OF_MEAN|1.592||0.1135|TWO_SIDED|95.0|-0.605|5.655|||ANCOVA|||Week 12: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 12 as an interaction term, baseline SF-36 MCS as the covariate; and participant as a random effect.||5.655|-0.605|0.1135
72435166|NCT00383188|144383176|SUPERIORITY||LSM Difference|2.63|STANDARD_ERROR_OF_MEAN|1.912||0.1697|TWO_SIDED|95.0|-1.128|6.388|||ANCOVA|||Week 12: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 12 as an interaction term, baseline SF-36 MCS as the covariate; and participant as a random effect.||6.388|-1.128|0.1697
72435167|NCT00383188|144383176|SUPERIORITY||LSM Difference|2.21|STANDARD_ERROR_OF_MEAN|1.918||0.25|TWO_SIDED|95.0|-1.561|5.981|||ANCOVA|||Week 12: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 12 as an interaction term, baseline SF-36 MCS as the covariate; and participant as a random effect.||5.981|-1.561|0.2500
72494221|NCT01100944|144517392|SUPERIORITY_OR_OTHER|||||||0.0001||||||Fold change at Cycle 1 Day 3 vs. pre was assessed. p values calculated were done using a Wilcoxon signed rank test relative to a ratio of 1.|Wilcoxon signed rank test|||||||0.0001
72494222|NCT02296242|144517396|OTHER||Highest dose (mg) with no DLTs.|600.0|||||TWO_SIDED|||||||||In Part 1, 2 patients experienced DLTs in the 750 mg b.i.d. treatment group (2/7; 29%). There were no dose-limiting toxicities in the 600 mg b.i.d. group or 300 mg b.i.d. group. Therefore, based on these results, 600 mg b.i.d. was selected as the MTD dose (and RP2D dose) which was used as the treatment dose in Part 2 of the study.||||
72504604|NCT01524289|144539987|SUPERIORITY||Median Difference (Final Values)|-27.9|||<|0.001|TWO_SIDED|95.0|-34.7|-21.2|||Wilcoxon (Mann-Whitney)||Hodges-Lehmann estimate of the median difference between treatments with a corresponding distribution-free confidence interval (CI) based on Wilcoxon's rank sum test.|||-21.2|-34.7|<0.001
72504605|NCT01821677|144540003|SUPERIORITY|||||||0.16|||||||ANCOVA|||||||0.16
72504606|NCT01821677|144540003|SUPERIORITY|||||||0.07|||||||ANCOVA|||||||0.07
72504607|NCT01821677|144540003|SUPERIORITY|||||||0.03|||||||ANCOVA|||||||0.03
72435168|NCT02476890|144383185|OTHER||Mean Difference (Final Values)|0.01||||0.9666|TWO_SIDED|95.0|-0.6|0.7|||Mixed Models Analysis|||C2 Response/Healthy||0.7|-0.6|0.9666
72435169|NCT02476890|144383185|OTHER||Mean Difference (Final Values)|-0.22||||0.5993|TWO_SIDED|95.0|-1.1|0.6|||Mixed Models Analysis|||C5 Response/Healthy||0.6|-1.1|0.5993
72435170|NCT02476890|144383185|OTHER||Mean Difference (Final Values)|0.32||||0.2823|TWO_SIDED|95.0|-0.3|0.9|||Mixed Models Analysis|||C2 Response/Chronic Cough||0.9|-0.3|0.2823
72435171|NCT02476890|144383185|OTHER||Mean Difference (Final Values)|0.25||||0.4287|TWO_SIDED|95.0|-0.4|0.9|||Mixed Models Analysis|||C5 Response/Chronic Cough||0.9|-0.4|0.4287
72435172|NCT02476890|144383186|OTHER||Mean Difference (Final Values)|0.56||||0.1771|TWO_SIDED|95.0|-0.3|1.4|||Mixed Models Analysis|||C2 Response/Healthy||1.4|-0.3|0.1771
72435173|NCT02476890|144383186|OTHER||Mean Difference (Final Values)|0.3||||0.5473|TWO_SIDED|95.0|-0.7|1.3|||Mixed Models Analysis|||C5 Response/Healthy||1.3|-0.7|0.5473
72435174|NCT02476890|144383186|OTHER||Mean Difference (Final Values)|0.23||||0.5169|TWO_SIDED|95.0|-0.5|1.0|||Mixed Models Analysis|||C2 Response/Chronic Cough||1.0|-0.5|0.5169
72435175|NCT02476890|144383186|OTHER||Mean Difference (Final Values)|0.28||||0.4243|TWO_SIDED|95.0|-0.4|1.0|||Mixed Models Analysis|||C5 Response/Chronic Cough||1.0|-0.4|0.4243
72435176|NCT02476890|144383187|OTHER||Mean Difference (Final Values)|0.89||||0.1125|TWO_SIDED|95.0|-0.2|2.0|||Mixed Models Analysis|||C2 Response/Healthy||2.0|-0.2|0.1125
72435177|NCT02476890|144383187|OTHER||Mean Difference (Final Values)|0.88||||0.0029|TWO_SIDED|95.0|0.4|1.4|||Mixed Models Analysis|||C5 Response/Healthy||1.4|0.4|0.0029
72435178|NCT02476890|144383187|OTHER||Mean Difference (Final Values)|1.54||||0.0006|TWO_SIDED|95.0|0.7|2.4|||Mixed Models Analysis|||C2 Response/Chronic Cough||2.4|0.7|0.0006
72435179|NCT02476890|144383187|OTHER||Mean Difference (Final Values)|1.3||||0.0067|TWO_SIDED|95.0|0.4|2.2|||Mixed Models Analysis|||C5 Response/Chronic Cough||2.2|0.4|0.0067
72435180|NCT02476890|144383188|OTHER||Mean Difference (Final Values)|0.38|||<|0.0001|TWO_SIDED|95.0|0.2|0.5|||Mixed Models Analysis|||C2 Response/Healthy||0.5|0.2|< 0.0001
72435181|NCT02476890|144383188|OTHER||Mean Difference (Final Values)|0.23||||0.1798|TWO_SIDED|95.0|-0.1|0.6|||Mixed Models Analysis|||C5 Response/Healthy||0.6|-0.1|0.1798
72435182|NCT02476890|144383188|OTHER||Mean Difference (Final Values)|0.3||||0.0011|TWO_SIDED|95.0|0.1|0.5|||Mixed Models Analysis|||C2 Response/Chronic Cough||0.5|0.1|0.0011
72435183|NCT02476890|144383188|OTHER||Mean Difference (Final Values)|0.28||||0.0023|TWO_SIDED|95.0|0.1|0.4|||Mixed Models Analysis|||C5 Response/Chronic Cough||0.4|0.1|0.0023
72435184|NCT02476890|144383189|OTHER||Mean Difference (Final Values)|-18.0||||0.0037|TWO_SIDED|95.0|-29.8|-6.2|||Mixed Models Analysis|||Cough Severity VAS Analysis||-6.2|-29.8|0.0037
72435185|NCT02476890|144383190|OTHER||Mean Difference (Final Values)|-18.0||||0.002|TWO_SIDED|95.0|-29.1|-7.0|||Mixed Models Analysis|||Urge to Cough VAS Analysis||-7.0|-29.1|0.0020
72435186|NCT02476890|144383191|OTHER||Mean Difference (Final Values)|-3.6||||0.0075|TWO_SIDED|95.0|-6.2|-1.0|||Mixed Models Analysis|||Cough Frequency Analysis||-1.0|-6.2|0.0075
72435187|NCT00835380|144383194|SUPERIORITY_OR_OTHER||Seroconversion Rate|99.0||||||95.0|89.0|99.0||||||||99|89|
72435188|NCT03247543|144383196|SUPERIORITY||Least Square Mean Difference|-6.0|STANDARD_ERROR_OF_MEAN|2.05||0.0038|TWO_SIDED|95.0|-10.0|-1.9|||Mixed Models for Repeated Measures|||||-1.9|-10.0|0.0038
72435189|NCT03247543|144383196|SUPERIORITY||Least Square Mean Difference|-5.8|STANDARD_ERROR_OF_MEAN|2.11||0.0063|TWO_SIDED|95.0|-9.9|-1.7|||Mixed Models for Repeated Measures|||||-1.7|-9.9|0.0063
72494223|NCT01077973|144517407|SUPERIORITY_OR_OTHER||Least-square (LS) mean difference|-1.12||||0.299|TWO_SIDED|95.0|-3.23|1.0||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR), gender and treatment-by-baseline PSR terms.|ANOVA|||Treatment difference (Ibuprofen sodium-placebo) and 95 percent (%) confidence interval (CI): based on LS means from analysis of variance (ANOVA). Type I error was controlled at 0.05 significance level (2-sided) by stating pair wise comparisons significant only if overall treatment effect among 3 treatment groups was significant and testing in a sequential order Ibuprofen sodium versus (vs.) placebo for SPRID 0-3 then Ibuprofen sodium vs. Ibuprofen (Motrin IB) for time to meaningful relief.||1.00|-3.23|0.299
72494224|NCT01077973|144517408|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.77||||0.193|TWO_SIDED|95.0|0.52|1.14||p-value was calculated using the PH model with treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|Proportional hazards model|||Hazard Ratio (HR) and corresponding 95% CI were calculated based on the Wald statistic from the proportional hazards (PH) model. Type I error was controlled at 0.05 significance level (2-sided) by stating pair wise comparisons significant only if overall treatment effect among 3 treatment groups was significant and testing in a sequential order Ibuprofen sodium vs. placebo for SPRID 0-3 then Ibuprofen sodium vs. Ibuprofen (Motrin IB) for time to meaningful relief.||1.14|0.52|0.193
72494225|NCT01077973|144517409|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.79||||0.304|TWO_SIDED|95.0|0.5|1.24||p-value was calculated using the PH model with treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|Proportional hazards model|||HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model.||1.24|0.50|0.304
72494226|NCT01077973|144517409|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.02||||0.936|TWO_SIDED|95.0|0.65|1.59||p-value was calculated using the PH model with treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|Proportional hazards model|||HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model.||1.59|0.65|0.936
72494227|NCT01077973|144517410|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.66||||0.072|TWO_SIDED|95.0|0.41|1.04||p-value was calculated using the PH model with treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|Proportional hazards model|||HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model.||1.04|0.41|0.072
72504608|NCT01821677|144540004|SUPERIORITY|||||||0.42|||||||ANCOVA|||||||0.42
72435190|NCT03247543|144383197|SUPERIORITY||Least Square Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.17||0.0028|TWO_SIDED|95.0|-0.8|-0.2|||ANCOVA|ANCOVA model with baseline Clinical Global Impression-Severity of Illness (CGI-S) score and treatment as fixed independent variables.||||-0.2|-0.8|0.0028
72435191|NCT03247543|144383197|SUPERIORITY||Least Square Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.17||0.0099|TWO_SIDED|95.0|-0.8|-0.1|||ANCOVA|ANCOVA model with baseline Clinical Global Impression-Severity of Illness (CGI-S) score and treatment as fixed independent variables.||||-0.1|-0.8|0.0099
72435192|NCT03247543|144383198|SUPERIORITY||Least Square Mean Difference|-3.8|STANDARD_ERROR_OF_MEAN|1.39||0.0064|TWO_SIDED|95.0|-6.5|-1.1|||ANCOVA|||||-1.1|-6.5|0.0064
72435193|NCT03247543|144383198|SUPERIORITY||Least Square Mean Difference|-2.5|STANDARD_ERROR_OF_MEAN|1.46||0.0917|TWO_SIDED|95.0|-5.3|0.4|||ANCOVA|||||0.4|-5.3|0.0917
72435194|NCT03247543|144383199|SUPERIORITY||Least Square Mean Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.059||0.0651|TWO_SIDED|95.0|-0.22|0.01|||ANCOVA|||||0.01|-0.22|0.0651
72435195|NCT03247543|144383199|SUPERIORITY||Least Square Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.061||0.168|TWO_SIDED|95.0|-0.2|0.04|||ANCOVA|||||0.04|-0.20|0.1680
72435196|NCT03247543|144383200|SUPERIORITY||Risk Difference (RD)|10.1||||0.1316|TWO_SIDED|95.0|-2.9|23.1|||Regression, Logistic|||||23.1|-2.9|0.1316
72435197|NCT03247543|144383200|SUPERIORITY||Risk Difference (RD)|15.4||||0.0276|TWO_SIDED|95.0|2.0|28.9|||Regression, Logistic|||||28.9|2.0|0.0276
72435198|NCT03247543|144383201|SUPERIORITY||Least Square Mean Difference|-3.4|STANDARD_ERROR_OF_MEAN|2.7||0.2128|TWO_SIDED|95.0|-8.7|1.9|||ANCOVA|||||1.9|-8.7|0.2128
72435199|NCT03247543|144383201|SUPERIORITY||Least Square Mean Difference|-5.8|STANDARD_ERROR_OF_MEAN|2.83||0.0409|TWO_SIDED|95.0|-11.3|-0.2|||ANCOVA|||||-0.2|-11.3|0.0409
72435200|NCT03247543|144383202|SUPERIORITY||Least Square Mean Difference|-3.3|STANDARD_ERROR_OF_MEAN|1.07||0.002|TWO_SIDED|95.0|-5.4|-1.2|||ANCOVA|||This analysis pertains to the Hyperactivity/Impulsivity subscale score||-1.2|-5.4|0.0020
72435201|NCT03247543|144383202|SUPERIORITY||Least Square Mean Difference|-3.2|STANDARD_ERROR_OF_MEAN|1.09||0.0039|TWO_SIDED|95.0|-5.3|-1.0|||ANCOVA|||This analysis pertains to the Hyperactivity/Impulsivity subscale score||-1.0|-5.3|0.0039
72435202|NCT03247543|144383202|SUPERIORITY||Least Square Mean Difference|-2.8|STANDARD_ERROR_OF_MEAN|1.05||0.0087|TWO_SIDED|95.0|-4.8|-0.7|||ANCOVA|||This analysis pertains to the Inattention subscale score||-0.7|-4.8|0.0087
72435203|NCT03247543|144383202|SUPERIORITY||Least Square Mean Difference|-2.4|STANDARD_ERROR_OF_MEAN|1.09||0.0248|TWO_SIDED|95.0|-4.6|-0.3|||ANCOVA|||This analysis pertains to the Inattention subscale score||-0.3|-4.6|0.0248
72435204|NCT03247543|144383203|SUPERIORITY||Least Square Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|1.43||0.7003|TWO_SIDED|95.0|-3.3|2.2|||ANCOVA|||||2.2|-3.3|0.7003
72435205|NCT03247543|144383203|SUPERIORITY||Least Square Mean Difference|-2.0|STANDARD_ERROR_OF_MEAN|1.45||0.1602|TWO_SIDED|95.0|-4.9|0.8|||ANCOVA|||||0.8|-4.9|0.1602
72383230|NCT00809354|144275215|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.37|STANDARD_ERROR_OF_MEAN|0.17||0.031|TWO_SIDED|95.0|-0.71|-0.03|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.03|-0.71|0.031
72494228|NCT01077973|144517410|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.9||||0.652|TWO_SIDED|95.0|0.58|1.41||p-value was calculated using the PH model with treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|Proportional hazards model|||HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model.||1.41|0.58|0.652
72383231|NCT00809354|144275215|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.17||0.349|TWO_SIDED|95.0|-0.49|0.17|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.17|-0.49|0.349
72383232|NCT00809354|144275215|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.05|STANDARD_ERROR_OF_MEAN|0.17||0.78|TWO_SIDED|95.0|-0.29|0.38|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.38|-0.29|0.780
72383233|NCT00809354|144275215|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.95|STANDARD_ERROR_OF_MEAN|0.19|<|0.001|TWO_SIDED|95.0|-1.31|-0.58|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.58|-1.31|<0.001
72383234|NCT00809354|144275215|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.93|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|95.0|-1.29|-0.56|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.56|-1.29|<0.001
72383235|NCT00809354|144275215|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.63|STANDARD_ERROR_OF_MEAN|0.19|<|0.001|TWO_SIDED|95.0|-0.99|-0.26|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.26|-0.99|<0.001
72383236|NCT00809354|144275215|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.52|STANDARD_ERROR_OF_MEAN|0.19||0.005|TWO_SIDED|95.0|-0.88|-0.15|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.15|-0.88|0.005
72383237|NCT00809354|144275215|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.19||0.562|TWO_SIDED|95.0|-0.47|0.26|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.26|-0.47|0.562
72383238|NCT00809354|144275215|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.41|STANDARD_ERROR_OF_MEAN|0.19||0.028|TWO_SIDED|95.0|-0.77|-0.04|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.04|-0.77|0.028
72383239|NCT00809354|144275215|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.32|STANDARD_ERROR_OF_MEAN|0.19||0.084|TWO_SIDED|95.0|-0.68|0.04|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.04|-0.68|0.084
72383240|NCT00809354|144275215|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.19||0.91|TWO_SIDED|95.0|-0.38|0.34|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.34|-0.38|0.910
72383241|NCT00809354|144275215|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.05|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|95.0|-1.4|-0.69|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.69|-1.40|<0.001
72383242|NCT00809354|144275215|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.91|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|95.0|-1.27|-0.56|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.56|-1.27|<0.001
72383243|NCT00809354|144275215|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|95.0|-1.25|-0.55|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.55|-1.25|<0.001
72383244|NCT00809354|144275215|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.53|STANDARD_ERROR_OF_MEAN|0.18||0.003|TWO_SIDED|95.0|-0.88|-0.17|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.17|-0.88|0.003
72383245|NCT00809354|144275215|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.37|STANDARD_ERROR_OF_MEAN|0.18||0.039|TWO_SIDED|95.0|-0.72|-0.02|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.02|-0.72|0.039
72383246|NCT00809354|144275215|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.39|STANDARD_ERROR_OF_MEAN|0.18||0.032|TWO_SIDED|95.0|-0.74|-0.03|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.03|-0.74|0.032
72383247|NCT00809354|144275215|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.18||0.409|TWO_SIDED|95.0|-0.5|0.2|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.20|-0.50|0.409
72383248|NCT00809354|144275215|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.18||0.461|TWO_SIDED|95.0|-0.49|0.22|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.22|-0.49|0.461
72383249|NCT00809354|144275215|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.21|STANDARD_ERROR_OF_MEAN|0.19|<|0.001|TWO_SIDED|95.0|-1.59|-0.84|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.84|-1.59|<0.001
72383250|NCT00809354|144275215|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.03|STANDARD_ERROR_OF_MEAN|0.19|<|0.001|TWO_SIDED|95.0|-1.4|-0.65|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.65|-1.40|<0.001
72383251|NCT00809354|144275215|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.19|<|0.001|TWO_SIDED|95.0|-1.17|-0.43|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.43|-1.17|<0.001
72504609|NCT01821677|144540004|SUPERIORITY|||||||0.28|||||||ANCOVA|||||||0.28
72383252|NCT00809354|144275215|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.59|STANDARD_ERROR_OF_MEAN|0.19||0.002|TWO_SIDED|95.0|-0.97|-0.22|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.22|-0.97|0.002
72383253|NCT00809354|144275215|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.21|STANDARD_ERROR_OF_MEAN|0.19||0.281|TWO_SIDED|95.0|-0.58|0.17|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.17|-0.58|0.281
72383254|NCT00809354|144275215|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.43|STANDARD_ERROR_OF_MEAN|0.19||0.023|TWO_SIDED|95.0|-0.81|-0.06|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.06|-0.81|0.023
72383255|NCT00809354|144275215|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.41|STANDARD_ERROR_OF_MEAN|0.19||0.031|TWO_SIDED|95.0|-0.79|-0.04|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.04|-0.79|0.031
72383256|NCT00809354|144275215|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.19||0.331|TWO_SIDED|95.0|-0.56|0.19|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.19|-0.56|0.331
72383257|NCT00809354|144275215|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.11|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|95.0|-1.47|-0.75|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.75|-1.47|<0.001
72435206|NCT03247543|144383204|SUPERIORITY|||||||0.0236|||||||Chi-squared|||This analysis pertains to Week 1 of treatment.||||0.0236
72435207|NCT03247543|144383204|SUPERIORITY|||||||0.0505|||||||Chi-squared|||This analysis pertains to Week 2 of treatment.||||0.0505
72435208|NCT03247543|144383204|SUPERIORITY|||||||0.1225|||||||Chi-squared|||This analysis pertains to Week 3 of treatment.||||0.1225
72435209|NCT03247543|144383204|SUPERIORITY|||||||0.0254|||||||Chi-squared|||This analysis pertains to Week 4 of treatment.||||0.0254
72435210|NCT03247543|144383204|SUPERIORITY|||||||0.0261|||||||Chi-squared|||This analysis pertains to Week 5 of treatment.||||0.0261
72435211|NCT03247543|144383204|SUPERIORITY|||||||0.0037|||||||Chi-squared|||This analysis pertains to Week 6 of treatment.||||0.0037
72435212|NCT03247543|144383204|SUPERIORITY|||||||0.0385|||||||Chi-squared|||This analysis pertains to Week 7 of treatment.||||0.0385
72504610|NCT01821677|144540004|SUPERIORITY|||||||0.14|||||||ANCOVA|||||||0.14
72383258|NCT00809354|144275215|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.97|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|95.0|-1.33|-0.6|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.60|-1.33|<0.001
72383259|NCT00809354|144275215|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.67|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|95.0|-1.03|-0.31|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.31|-1.03|<0.001
72435213|NCT03247543|144383204|SUPERIORITY|||||||0.0956|||||||Chi-squared|||This analysis pertains to Week 8 of treatment.||||0.0956
72435214|NCT03247543|144383204|SUPERIORITY|||||||0.0962|||||||Chi-squared|||This analysis pertains to Week 1 of treatment.||||0.0962
72435215|NCT03247543|144383204|SUPERIORITY|||||||0.0744|||||||Chi-squared|||This analysis pertains to Week 2 of treatment.||||0.0744
72435216|NCT03247543|144383204|SUPERIORITY|||||||0.0218|||||||Chi-squared|||This analysis pertains to Week 3 of treatment.||||0.0218
72435217|NCT03247543|144383204|SUPERIORITY|||||||0.115|||||||Chi-squared|||This analysis pertains to Week 4 of treatment.||||0.1150
72435218|NCT03247543|144383204|SUPERIORITY|||||||0.1086|||||||Chi-squared|||This analysis pertains to Week 5 of treatment.||||0.1086
72435219|NCT03247543|144383204|SUPERIORITY|||||||0.0082|||||||Chi-squared|||This analysis pertains to Week 6 of treatment.||||0.0082
72435220|NCT03247543|144383204|SUPERIORITY|||||||0.2326|||||||Chi-squared|||This analysis pertains to Week 7 of treatment.||||0.2326
72435221|NCT03247543|144383204|SUPERIORITY|||||||0.0883|||||||Chi-squared|||This analysis pertains to Week 8 of treatment.||||0.0883
72435222|NCT01097343|144383205|SUPERIORITY_OR_OTHER||||||=|0.02|TWO_SIDED|95.0|||||Chi-squared|||A sample of size of 50 patients for the cross-over study was chosen because it provided 80% power to detect a decrease in the rate of high on-clopidogrel platelet reactivity (HPR, defined as \>230 PRU) from 75% to 46% with high dose clopidogrel, with a two-sided alpha of 0.05||||=0.02
72435223|NCT02059980|144383206|SUPERIORITY||||||=|0.56|||||||Mixed Models Analysis|||It was calculated that 30 participants rnadomized in a 1:1 fashion between the 2 arms would have .90 power to detect a large effect (f=.40), but is somewhat underpowered to detect a medium effect (f=.25) between the two groups. Sample size was determined using a repeated-measures ANOVA test (α = .05, a correlation of .5 among repeated measures, and a nonsphericity correction of .6), considering the design effect and potential patient attrition (=25%).||||= 0.56
72435224|NCT02059980|144383207|SUPERIORITY||||||=|0.98|||||||Mixed Models Analysis|||It was calculated that 30 participants randomized in a 1:1 fashion between the 2 arms would have .90 power to detect a large effect (f=.40), but is somewhat underpowered to detect a medium effect (f=.25) between the two groups. Sample size was determined using a repeated-measures ANOVA test (α = .05, a correlation of .5 among repeated measures, and a nonsphericity correction of .6), considering the design effect and potential patient attrition (=25%).||||=.98
72435225|NCT01726023|144383250|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority would be concluded if the lower limit of the 95% confidence interval (CI; corresponding to a 97.5% 1 sided lower bound) was greater than -12.5% for the primary outcome variable.|Risk Difference (RD)|-0.2|||<|0.001|TWO_SIDED|95.0|-5.53|4.97||P-value for 1-sided test at test of cure (TOC) with a -12.5% non-inferiority margin, i.e. H0: diff ≤ -12.5%.|% Risk Difference (RD)|RD is CAZ AVI clinical cure rate minus Meropenem clinical cure rate. The CI was calculated by Miettinen and Nurminen method without adjustment.|units for RD are %|The Primary objective of this study was to assess the non inferiority (based on a 12.5% margin) of CAZ AVI plus metronidazole compared to meropenem alone with respect to clinical cure at the TOC visit in patients who were CE.||4.97|-5.53|<0.001
72557954|NCT00205777|144645472|SUPERIORITY_OR_OTHER|||||||0.12|TWO_SIDED||||||ANOVA|||Change at Month 12 in WHQ: P value was calculated using ANOVA.||||0.12
72494229|NCT01077973|144517410|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.73||||0.108|TWO_SIDED|95.0|0.49|1.07||p-value was calculated using the PH model with treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|Proportional hazards model|||HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model.||1.07|0.49|0.108
72494230|NCT01077973|144517411|SUPERIORITY_OR_OTHER||LS mean difference|-0.19||||0.402|TWO_SIDED|95.0|-0.65|0.26||p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1 hour: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.26|-0.65|0.402
72494231|NCT01077973|144517411|SUPERIORITY_OR_OTHER||LS mean difference|-0.19||||0.407|TWO_SIDED|95.0|-0.64|0.26||p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1 hour: Treatment difference \[Ibuprofen (Motrin IB) - placebo\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.26|-0.64|0.407
72557955|NCT00205777|144645472|SUPERIORITY_OR_OTHER|||||||0.17|TWO_SIDED||||||ANOVA|||Change at Month 12 in WHQ: P value was calculated using ANOVA.||||0.17
72435226|NCT01726023|144383283|SUPERIORITY_OR_OTHER||Difference in median time (days)|0.5||||0.773|||||||Log Rank|||||||0.773
72557956|NCT00205777|144645472|SUPERIORITY_OR_OTHER|||||||0.92||95.0|||||ANOVA|||Change at Month 12 in WHQ: P value was calculated using ANOVA.||||0.92
72383260|NCT00809354|144275215|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.62|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|95.0|-0.98|-0.26|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.26|-0.98|<0.001
72383261|NCT00809354|144275215|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.18||0.781|TWO_SIDED|95.0|-0.41|0.31|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.31|-0.41|0.781
72383262|NCT00809354|144275215|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.35|STANDARD_ERROR_OF_MEAN|0.18||0.057|TWO_SIDED|95.0|-0.71|0.01|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.01|-0.71|0.057
72383263|NCT00809354|144275215|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.44|STANDARD_ERROR_OF_MEAN|0.18||0.016|TWO_SIDED|95.0|-0.8|-0.08|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.08|-0.80|0.016
72435227|NCT01726023|144383284|SUPERIORITY_OR_OTHER||Difference in median time (days)|1.0||||0.598|||||||Log Rank|||||||0.598
72383264|NCT00809354|144275215|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.18||0.45|TWO_SIDED|95.0|-0.5|0.22|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.22|-0.50|0.450
72435228|NCT00414206|144383291|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANCOVA|||||||>0.05
72435229|NCT03368001|144383304|OTHER|We used structural equation modeling (SEM), as implemented in Mplus 8.7, as a framework for testing all primary hypotheses. We accounted for any non-independence of observations due to cohort membership by obtaining cluster-robust standard errors using robust maximum likelihood estimation (MLR in Mplus) in tandem with the Type = Complex option available in Mplus, treating cohorts as clusters. All models were structurally saturated, so model fit was necessarily perfect.||||||0.039||||||IFM Posttest.|Structural Equation Modeling|We used structural equation modeling (SEM), as implemented in Mplus 8.7, as a framework for testing all primary hypotheses.||Population models were specified using parameter values derived from past research in tandem with minimal expected effect sizes for the effects of most interest. These models were used to generate 5000 samples for a given N, the models were fit to each sample, and the significance (or not) of key effects was noted. This process was repeated until the target power of at least .80 was reached indicating with 216 participants we would have .82 power.||||.039
72435230|NCT03368001|144383304|OTHER|The residuals associated with the mediator and outcome were allowed to covary with the lag and pretest scores associated with the outcome, and the residual associated with the outcome was allowed to covary with the lag and pretest scores associated with the mediator.|Structural Equation Model (SEM)|0.064|||<|0.05|TWO_SIDED|90.0|0.014|0.118||One-tailed significance test|Structural Equation Model (SEM)|Controlling for Verbal Expressiveness at Pretest and the interval between Pretest and the Followup assessments.|Estimation parameter represents indirect effect (axb)|The indirect effect of SENSE Theatre® vs. TTT through post-test IFM on follow-up Vocal Expressiveness. We adjusted standard errors for cohort, controlled the mediator for individual differences in lag between pretest and posttest for the a path and controlled the outcome for individual differences in lag between pretest to follow-up for the b and c' paths.||0.118|0.014|<0.05
72435231|NCT03368001|144383304|OTHER|The residual associated with the mediator was allowed to covary with the lag and pretest scores associated with the outcome, and the residual associated with the outcome was allowed to covary with the lag and pretest scores associated with the mediator, yielding a saturated model.|Structural Equation Model (SEM)|0.032|||<|0.05|TWO_SIDED|90.0|0.002|0.087||One-sided hypothesis test.|Structural Equation Model (SEM)|Controlling for Rapport at Pretest and the interval between Pretest and the Followup assessments.|Estimation parameter represents indirect effect (axb)|The partially standardized indirect effect of treatment on follow-up Quality of Rapport through posttest Incidental Face Memory. We adjusted standard errors for cohort, controlled the mediator for individual differences in lag (pretest to posttest) and baseline mediator, and controlled the outcome for individual differences in lag (pretest to follow-up) and baseline outcome.||0.087|0.002|<0.05
72435232|NCT03368001|144383304|OTHER|The residuals associated with the mediator and outcome were allowed to covary with the lag and pretest scores associated with the outcome, and the residual associated with the outcome was allowed to covary with the lag and pretest scores associated with the mediator, yielding a saturated model.|Structural Equation Model (SEM)|0.005|||>|0.05|TWO_SIDED|90.0|-0.015|0.059||One-sided hypothesis test|Structural Equation Model (SEM)|Controlling for Social Anxiety at Pretest and the interval between Pretest and the Followup assessments.|Estimation parameter represents indirect effect (axb)|The partially standardized indirect effect of treatment on follow-up Social Anxiety through posttest IFM. Adjusted standard errors for cohort, controlled the mediator for individual differences in lag between pretest and posttest for the a path and controlled the outcome for individual differences in lag between pretest to follow-up for the b and c' paths.||0.059|-0.015|>0.05
72494232|NCT01077973|144517411|SUPERIORITY_OR_OTHER||LS mean difference|0.0||||0.991|TWO_SIDED|95.0|-0.38|0.37||p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1 hour: Treatment difference \[Ibuprofen sodium - Ibuprofen (Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.37|-0.38|0.991
72383265|NCT00809354|144275215|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.08|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|-1.47|-0.69|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.69|-1.47|<0.001
72494233|NCT01077973|144517411|SUPERIORITY_OR_OTHER||LS mean difference|-0.25||||0.313|TWO_SIDED|95.0|-0.75|0.24||p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||2 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.24|-0.75|0.313
72494234|NCT01077973|144517411|SUPERIORITY_OR_OTHER||LS mean difference|-0.12||||0.621|TWO_SIDED|95.0|-0.62|0.37||p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||2 hours: Treatment difference \[Ibuprofen (Motrin IB) - placebo\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.37|-0.62|0.621
72494235|NCT01077973|144517411|SUPERIORITY_OR_OTHER||LS mean difference|-0.13||||0.533|TWO_SIDED|95.0|-0.54|0.28||p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||2 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.28|-0.54|0.533
72494236|NCT01077973|144517411|SUPERIORITY_OR_OTHER||LS mean difference|-0.25||||0.352|TWO_SIDED|95.0|-0.79|0.28||p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||3 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.28|-0.79|0.352
72494237|NCT01077973|144517411|SUPERIORITY_OR_OTHER||LS mean difference|-0.15||||0.573|TWO_SIDED|95.0|-0.69|0.38||p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||3 hours: Treatment difference \[Ibuprofen (Motrin IB) - placebo\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.38|-0.69|0.573
72494238|NCT01077973|144517411|SUPERIORITY_OR_OTHER||LS mean difference|-0.1||||0.657|TWO_SIDED|95.0|-0.54|0.34||p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||3 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.34|-0.54|0.657
72494239|NCT01077973|144517412|SUPERIORITY_OR_OTHER||LS mean difference|-0.11||||0.382|TWO_SIDED|95.0|-0.36|0.14||p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1 hour: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.14|-0.36|0.382
72494240|NCT01077973|144517412|SUPERIORITY_OR_OTHER||LS mean difference|-0.15||||0.242|TWO_SIDED|95.0|-0.39|0.1||p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1 hour: Treatment difference \[Ibuprofen (Motrin IB) - placebo\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.10|-0.39|0.242
72494241|NCT01077973|144517412|SUPERIORITY_OR_OTHER||LS mean difference|0.04||||0.72|TWO_SIDED|95.0|-0.17|0.24||p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1 hour: Treatment difference \[Ibuprofen sodium - Ibuprofen (Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.24|-0.17|0.720
72383266|NCT00809354|144275215|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.81|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|-1.2|-0.42|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.42|-1.20|<0.001
72383267|NCT00809354|144275215|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.73|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|-1.12|-0.34|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.34|-1.12|<0.001
72383268|NCT00809354|144275215|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.65|STANDARD_ERROR_OF_MEAN|0.2||0.001|TWO_SIDED|95.0|-1.04|-0.26|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.26|-1.04|0.001
72383269|NCT00809354|144275215|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.2||0.699|TWO_SIDED|95.0|-0.47|0.31|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.31|-0.47|0.699
72383270|NCT00809354|144275215|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.2||0.408|TWO_SIDED|95.0|-0.55|0.22|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.22|-0.55|0.408
72383271|NCT00809354|144275215|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.35|STANDARD_ERROR_OF_MEAN|0.2||0.077|TWO_SIDED|95.0|-0.74|0.04|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.04|-0.74|0.077
72383272|NCT00809354|144275215|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.26|STANDARD_ERROR_OF_MEAN|0.2||0.182|TWO_SIDED|95.0|-0.65|0.12|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.12|-0.65|0.182
72383273|NCT00809354|144275216|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.16||0.798|TWO_SIDED|95.0|-0.36|0.28|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.28|-0.36|0.798
72435233|NCT03368001|144383304|OTHER|The residuals associated with the mediator and outcome were allowed to covary with the lag and pretest scores associated with the outcome, and the residual associated with the outcome was allowed to covary with the lag and pretest scores associated with the mediator, yielding a saturated model.|Structural Equation Model (SEM)|-0.0002|||>|0.05|TWO_SIDED|90.0|-0.054|0.061||One-sided hypothesis test|Structural Equation Model (SEM)|Controlling for SRS-2 Social Communication at Pretest and the interval between Pretest and the Followup assessments.|Estimation parameter represents indirect effect (axb)|The partially standardized indirect effect of treatment on follow-up SRS Communication. We adjusted standard errors for cohort, controlled the mediator for individual differences in lag between pretest and posttest for the a path and controlled the outcome for individual differences in lag between pretest to follow-up for the b and c' paths.||0.061|-0.054|>0.05
72435234|NCT03368001|144383305|OTHER|||||||0.49||||||SRS Communication Posttest.|Structural Equation Modeling|We used structural equation modeling (SEM), as implemented in Mplus 8.7, as a framework for testing all primary hypotheses.||||||.490
72435235|NCT03368001|144383306|OTHER|Posttest ANCOVA controlling for pre-test scores||||||0.704|||||||ANCOVA|||||||0.704
72557957|NCT00205777|144645472|SUPERIORITY_OR_OTHER|||||||0.86||95.0|||||ANOVA|||Change at Month 12 in WHQ: P value was calculated using ANOVA.||||0.86
72435236|NCT03368001|144383306|OTHER|Followup ANCOVA controlling for pretest values||||||0.406|||||||ANCOVA|||||||0.406
72435237|NCT03368001|144383307|OTHER|||||||0.217|||||||Structural Equation Modeling|We used structural equation modeling (SEM), as implemented in Mplus 8.7, as a framework for testing all primary hypotheses.||Vocal Expressiveness Posttest.||||.217
72435238|NCT03368001|144383307|OTHER|||||||0.448|||||||Structural Equation Modeling|We used structural equation modeling (SEM), as implemented in Mplus 8.7, as a framework for testing all primary hypotheses||Quality of Rapport Posttest.||||.448
72435239|NCT03368001|144383307|OTHER|||||||0.15|||||||Structural Equation Modeling|We used structural equation modeling (SEM), as implemented in Mplus 8.7, as a framework for testing all primary hypotheses||Social Anxiety Posttest.||||.150
72435240|NCT03368001|144383308|OTHER|Posttest ANCOVA controlling for pre-test values||||||0.169|||||||ANCOVA|||||||0.169
72435241|NCT03368001|144383308|OTHER|Followup ANCOVA controlling for pretest values.||||||0.555|||||||ANCOVA|||||||0.555
72435242|NCT00556543|144383327|NON_INFERIORITY_OR_EQUIVALENCE|No power calculation performed.||||||0.19||95.0|||||Fisher Exact|||Fisher's Exact Test with the null hypothesis that the proportion with adverse events was the same in both groups.||||0.190
72494242|NCT01077973|144517412|SUPERIORITY_OR_OTHER||LS mean difference|-0.16||||0.235|TWO_SIDED|95.0|-0.43|0.11||p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||2 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.11|-0.43|0.235
72435243|NCT01838551|144383338|SUPERIORITY|Under the null hypothesis of at most 20% UFC responders, 90 subjects in the ITT population would provide 90% power, with two-sided type 1 error of 0.05, assuming an observed response of 35%.||||||0.0154||||||One-sided p-value is based on a null hypothesis that true response proportion is ≤ 0.20.|Mixed Models Analysis|The Generalized Linear Model described above was used to generate the p-value.||The least squares mean (LSMEAN) estimate of the UFC response after 6 months of treatment in the Maintenance Phase alongside its 95% Wald CI is presented. Supportive to the 95% CI, the p-value corresponding to the null hypothesis that the response rate is ≤ 20% is presented (1-sided test).||||0.0154
72435244|NCT02317016|144383388|NON_INFERIORITY_OR_EQUIVALENCE|No effect on the PK of rosuvastatin after co-administration of AZD9291 was concluded if the 2-sided 90% confidence intervals (CIs) for the ratios of rosuvastatin AUC and Cmax were within the range of 70% to 143%.|Geometric least-squares (LS) mean ratio|171.92|||||TWO_SIDED|90.0|145.94|202.53|||||AZD9291+ rosuvastatin / rosuvastatin alone (Day 32 versus Day 1).|Natural log-transformed Cmax values were compared between treatments using a mixed effects analysis of variance (ANOVA) with treatment as a fixed effect and patient as a random effect. It was assumed the within-patient coefficient of variation for rosuvastatin in both area under the plasma concentration-time curve (AUC) and Cmax was 41%. No change in the exposure for rosuvastatin when given with AZD9291 was also assumed.||202.53|145.94|
72435245|NCT02317016|144383389|NON_INFERIORITY_OR_EQUIVALENCE|No effect on the PK of rosuvastatin after co-administration of AZD9291 was concluded if the 2-sided 90% CIs for the ratios of rosuvastatin AUC and Cmax were within the range of 70% to 143%.|Geometric LS Mean Ratio|134.63|||||TWO_SIDED|90.0|115.41|157.07|||||AZD9291+ rosuvastatin / rosuvastatin alone (Day 32 versus Day 1).|Natural log-transformed AUC values were compared between treatments using a mixed effects ANOVA with treatment as a fixed effect and patient as a random effect. It was assumed the within-patient coefficient of variation for rosuvastatin in both AUC and Cmax was 41%. No change in the exposure for rosuvastatin when given with AZD9291 was also assumed.||157.07|115.41|
72435246|NCT00536380|144383402|SUPERIORITY_OR_OTHER_LEGACY|||||||0.721||95.0|||||ANCOVA|||||||0.721
72435247|NCT01670110|144383403|SUPERIORITY|||||||0.001|||||||ANCOVA|||||||0.001
72557958|NCT00205777|144645472|SUPERIORITY_OR_OTHER|||||||0.18||95.0|||||ANOVA|||Change at Month 24 in WHQ: P value was calculated using ANOVA.||||0.18
72435248|NCT01670110|144383404|SUPERIORITY|||||||0.003|||||||ANCOVA|||||||0.003
72435249|NCT01670110|144383405|SUPERIORITY|||||||0.79|||||||t-test, 2 sided|||||||0.79
72435250|NCT01670110|144383406|SUPERIORITY|||||||0.79|||||||t-test, 2 sided|||||||0.79
72435251|NCT01670110|144383407|SUPERIORITY|||||||0.001|||||||t-test, 2 sided|||||||0.001
72435252|NCT01670110|144383408|SUPERIORITY|||||||0.001|||||||t-test, 2 sided|||||||0.001
72435253|NCT01670110|144383409|SUPERIORITY|||||||0.73|||||||t-test, 2 sided|||||||0.73
72557959|NCT00205777|144645472|SUPERIORITY_OR_OTHER|||||||0.12||95.0|||||ANOVA|||Change at Month 24 in WHQ: P value was calculated using ANOVA.||||0.12
72557960|NCT00205777|144645472|SUPERIORITY_OR_OTHER|||||||0.096||95.0|||||ANOVA|||Change at Month 24 in WHQ: P value was calculated using ANOVA.||||0.096
72383274|NCT00809354|144275216|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.16||0.779|TWO_SIDED|95.0|-0.37|0.28|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.28|-0.37|0.779
72383275|NCT00809354|144275216|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.31|STANDARD_ERROR_OF_MEAN|0.17||0.057|TWO_SIDED|95.0|-0.64|0.01|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.01|-0.64|0.057
72383276|NCT00809354|144275216|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.16||0.927|TWO_SIDED|95.0|-0.31|0.34|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.34|-0.31|0.927
72383277|NCT00809354|144275216|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.16||0.98|TWO_SIDED|95.0|-0.33|0.32|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.32|-0.33|0.980
72383278|NCT00809354|144275216|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.27|STANDARD_ERROR_OF_MEAN|0.16||0.098|TWO_SIDED|95.0|-0.6|0.05|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.05|-0.60|0.098
72383279|NCT00809354|144275216|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.06|STANDARD_ERROR_OF_MEAN|0.16||0.709|TWO_SIDED|95.0|-0.26|0.38|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.38|-0.26|0.709
72383280|NCT00809354|144275216|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.33|STANDARD_ERROR_OF_MEAN|0.16||0.045|TWO_SIDED|95.0|0.01|0.65|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.65|0.01|0.045
72383281|NCT00809354|144275216|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.17||0.919|TWO_SIDED|95.0|-0.36|0.33|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.33|-0.36|0.919
72383282|NCT00809354|144275216|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.23|STANDARD_ERROR_OF_MEAN|0.17||0.183|TWO_SIDED|95.0|-0.11|0.58|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.58|-0.11|0.183
72383283|NCT00809354|144275216|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.17||0.504|TWO_SIDED|95.0|-0.46|0.23|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.23|-0.46|0.504
72383284|NCT00809354|144275216|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.06|STANDARD_ERROR_OF_MEAN|0.17||0.71|TWO_SIDED|95.0|-0.28|0.41|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.41|-0.28|0.710
72383285|NCT00809354|144275216|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.25|STANDARD_ERROR_OF_MEAN|0.17||0.152|TWO_SIDED|95.0|-0.09|0.59|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.59|-0.09|0.152
72383286|NCT00809354|144275216|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.17||0.572|TWO_SIDED|95.0|-0.44|0.24|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.24|-0.44|0.572
72383287|NCT00809354|144275216|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.17||0.337|TWO_SIDED|95.0|-0.51|0.18|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.18|-0.51|0.337
72383288|NCT00809354|144275216|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.18|STANDARD_ERROR_OF_MEAN|0.17||0.299|TWO_SIDED|95.0|-0.16|0.52|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.52|-0.16|0.299
72383289|NCT00809354|144275216|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.48|STANDARD_ERROR_OF_MEAN|0.17||0.005|TWO_SIDED|95.0|-0.82|-0.14|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.14|-0.82|0.005
72383290|NCT00809354|144275216|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.71|STANDARD_ERROR_OF_MEAN|0.17|<|0.001|TWO_SIDED|95.0|-1.05|-0.38|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.38|-1.05|<0.001
72383291|NCT00809354|144275216|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.91|STANDARD_ERROR_OF_MEAN|0.17|<|0.001|TWO_SIDED|95.0|-1.25|-0.57|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.57|-1.25|<0.001
72383292|NCT00809354|144275216|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|0.17|<|0.001|TWO_SIDED|95.0|-1.23|-0.56|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.56|-1.23|<0.001
72383293|NCT00809354|144275216|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.23|STANDARD_ERROR_OF_MEAN|0.17||0.177|TWO_SIDED|95.0|-0.57|0.1|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.10|-0.57|0.177
72383294|NCT00809354|144275216|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.42|STANDARD_ERROR_OF_MEAN|0.17||0.014|TWO_SIDED|95.0|-0.76|-0.09|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.09|-0.76|0.014
72383295|NCT00809354|144275216|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.17||0.286|TWO_SIDED|95.0|-0.52|0.15|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.15|-0.52|0.286
72383296|NCT00809354|144275216|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.17||0.952|TWO_SIDED|95.0|-0.33|0.35|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.35|-0.33|0.952
72383297|NCT00809354|144275216|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.58|STANDARD_ERROR_OF_MEAN|0.19||0.002|TWO_SIDED|95.0|-0.95|-0.21|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.21|-0.95|0.002
72383298|NCT00809354|144275216|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.57|STANDARD_ERROR_OF_MEAN|0.19||0.003|TWO_SIDED|95.0|-0.94|-0.2|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.20|-0.94|0.003
72557961|NCT00205777|144645472|SUPERIORITY_OR_OTHER|||||||0.76||95.0|||||ANOVA|||Change at Month 24 in WHQ: P value was calculated using ANOVA.||||0.76
72557962|NCT00205777|144645472|SUPERIORITY_OR_OTHER|||||||0.93||95.0|||||ANOVA|||Change at Month 24 in WHQ: P value was calculated using ANOVA.||||0.93
72383299|NCT00809354|144275216|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.89|STANDARD_ERROR_OF_MEAN|0.19|<|0.001|TWO_SIDED|95.0|-1.26|-0.52|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.52|-1.26|<0.001
72383300|NCT00809354|144275216|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.92|STANDARD_ERROR_OF_MEAN|0.19|<|0.001|TWO_SIDED|95.0|-1.29|-0.55|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.55|-1.29|<0.001
72383301|NCT00809354|144275216|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.19||0.972|TWO_SIDED|95.0|-0.36|0.38|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.38|-0.36|0.972
72383302|NCT00809354|144275216|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.31|STANDARD_ERROR_OF_MEAN|0.19||0.096|TWO_SIDED|95.0|-0.69|0.06|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.06|-0.69|0.096
72383303|NCT00809354|144275216|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.34|STANDARD_ERROR_OF_MEAN|0.19||0.069|TWO_SIDED|95.0|-0.72|0.03|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.03|-0.72|0.069
72383304|NCT00809354|144275216|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.19||0.902|TWO_SIDED|95.0|-0.39|0.35|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.35|-0.39|0.902
72383305|NCT00809354|144275216|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.57|STANDARD_ERROR_OF_MEAN|0.18||0.002|TWO_SIDED|95.0|-0.93|-0.22|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.22|-0.93|0.002
72383306|NCT00809354|144275216|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.97|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|95.0|-1.33|-0.61|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.61|-1.33|<0.001
72383307|NCT00809354|144275216|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.02|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|95.0|-1.38|-0.66|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.66|-1.38|<0.001
72383308|NCT00809354|144275216|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.19|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|95.0|-1.55|-0.84|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.84|-1.55|<0.001
72383309|NCT00809354|144275216|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.18||0.028|TWO_SIDED|95.0|-0.75|-0.04|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.04|-0.75|0.028
72383310|NCT00809354|144275216|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.45|STANDARD_ERROR_OF_MEAN|0.18||0.013|TWO_SIDED|95.0|-0.81|-0.09|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.09|-0.81|0.013
72383311|NCT00809354|144275216|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.18||0.217|TWO_SIDED|95.0|-0.58|0.13|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.13|-0.58|0.217
72383312|NCT00809354|144275216|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.18||0.351|TWO_SIDED|95.0|-0.53|0.19|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.19|-0.53|0.351
72383313|NCT00809354|144275216|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.66|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|-1.05|-0.28|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.28|-1.05|<0.001
72383314|NCT00809354|144275216|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.83|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|-1.22|-0.45|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.45|-1.22|<0.001
72383315|NCT00809354|144275216|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|-1.38|-0.62|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.62|-1.38|<0.001
72383316|NCT00809354|144275216|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.19|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|-1.57|-0.8|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.80|-1.57|<0.001
72383317|NCT00809354|144275216|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.2||0.389|TWO_SIDED|95.0|-0.55|0.22|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.22|-0.55|0.389
72383318|NCT00809354|144275216|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.34|STANDARD_ERROR_OF_MEAN|0.2||0.087|TWO_SIDED|95.0|-0.72|0.05|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.05|-0.72|0.087
72557963|NCT00205777|144645472|SUPERIORITY_OR_OTHER|||||||0.36||95.0|||||ANOVA|||Change at Month 36 in WHQ: P value was calculated using ANOVA.||||0.36
72557964|NCT00205777|144645472|SUPERIORITY_OR_OTHER|||||||0.34||95.0|||||ANOVA|||Change at Month 36 in WHQ: P value was calculated using ANOVA.||||0.34
72557965|NCT00205777|144645472|SUPERIORITY_OR_OTHER|||||||0.98||95.0|||||ANOVA|||Change at Month 36 in WHQ: P value was calculated using ANOVA.||||0.98
72557966|NCT00205777|144645472|SUPERIORITY_OR_OTHER|||||||0.35||95.0|||||ANOVA|||Change at Month 36 in WHQ: P value was calculated using ANOVA.||||0.35
72557967|NCT00205777|144645472|SUPERIORITY_OR_OTHER|||||||0.35||95.0|||||ANOVA|||Change at Month 36 in WHQ: P value was calculated using ANOVA.||||0.35
72557968|NCT00205777|144645474|SUPERIORITY_OR_OTHER|||||||0.08|TWO_SIDED||||||ANOVA|||Change at Month 12 in QUALEFFO: P value was calculated using ANOVA.||||0.080
72557969|NCT00205777|144645474|SUPERIORITY_OR_OTHER|||||||0.41|TWO_SIDED||||||ANOVA|||Change at Month 12 in QUALEFFO: P value was calculated using ANOVA.||||0.41
72435254|NCT01670110|144383410|SUPERIORITY|||||||0.31|||||||t-test, 2 sided|||Physical functioning||||0.31
72435255|NCT01670110|144383410|SUPERIORITY|||||||0.48|||||||t-test, 2 sided|||Physical role||||0.48
72383319|NCT00809354|144275216|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.35|STANDARD_ERROR_OF_MEAN|0.2||0.072|TWO_SIDED|95.0|-0.74|0.03|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.03|-0.74|0.072
72383320|NCT00809354|144275216|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.2||0.34|TWO_SIDED|95.0|-0.57|0.2|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.20|-0.57|0.340
72383321|NCT00809354|144275216|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.69|STANDARD_ERROR_OF_MEAN|0.19|<|0.001|TWO_SIDED|95.0|-1.06|-0.33|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.33|-1.06|<0.001
72383322|NCT00809354|144275216|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.75|STANDARD_ERROR_OF_MEAN|0.19|<|0.001|TWO_SIDED|95.0|-1.11|-0.39|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.39|-1.11|<0.001
72383323|NCT00809354|144275216|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.05|STANDARD_ERROR_OF_MEAN|0.19|<|0.001|TWO_SIDED|95.0|-1.42|-0.69|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.69|-1.42|<0.001
72383324|NCT00809354|144275216|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.23|STANDARD_ERROR_OF_MEAN|0.19|<|0.001|TWO_SIDED|95.0|-1.59|-0.87|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.87|-1.59|<0.001
72383325|NCT00809354|144275216|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.18||0.762|TWO_SIDED|95.0|-0.42|0.31|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.31|-0.42|0.762
72383326|NCT00809354|144275216|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.36|STANDARD_ERROR_OF_MEAN|0.19||0.056|TWO_SIDED|95.0|-0.72|0.01|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.01|-0.72|0.056
72383327|NCT00809354|144275216|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.48|STANDARD_ERROR_OF_MEAN|0.18||0.01|TWO_SIDED|95.0|-0.84|-0.12|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.12|-0.84|0.010
72383328|NCT00809354|144275216|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.19||0.335|TWO_SIDED|95.0|-0.54|0.19|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.19|-0.54|0.335
72383329|NCT00809354|144275216|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.78|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|-1.18|-0.38|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.38|-1.18|<0.001
72383330|NCT00809354|144275216|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.84|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|-1.24|-0.44|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.44|-1.24|<0.001
72383331|NCT00809354|144275216|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.85|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|-1.25|-0.46|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.46|-1.25|<0.001
72383332|NCT00809354|144275216|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.13|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|-1.52|-0.73|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.73|-1.52|<0.001
72383333|NCT00809354|144275216|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.2||0.782|TWO_SIDED|95.0|-0.46|0.34|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.34|-0.46|0.782
72383334|NCT00809354|144275216|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.2||0.719|TWO_SIDED|95.0|-0.47|0.33|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.33|-0.47|0.719
72383335|NCT00809354|144275216|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.29|STANDARD_ERROR_OF_MEAN|0.2||0.158|TWO_SIDED|95.0|-0.69|0.11|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.11|-0.69|0.158
72383336|NCT00809354|144275216|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.27|STANDARD_ERROR_OF_MEAN|0.2||0.183|TWO_SIDED|95.0|-0.67|0.13|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.13|-0.67|0.183
72383337|NCT00809354|144275216|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.54|STANDARD_ERROR_OF_MEAN|0.18||0.004|TWO_SIDED|95.0|-0.9|-0.18|||ANCOVA|||Change at Week 16: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.18|-0.90|0.004
72383338|NCT00809354|144275216|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.69|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|95.0|-1.05|-0.33|||ANCOVA|||Change at Week 16: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.33|-1.05|<0.001
72435256|NCT01670110|144383410|SUPERIORITY|||||||0.89|||||||t-test, 2 sided|||Bodily pain||||0.89
72435257|NCT01670110|144383410|SUPERIORITY|||||||0.18|||||||t-test, 2 sided|||General health||||0.18
72494243|NCT01077973|144517412|SUPERIORITY_OR_OTHER||LS mean difference|-0.07||||0.63|TWO_SIDED|95.0|-0.34|0.2||p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||2 hours: Treatment difference \[Ibuprofen (Motrin IB) - placebo\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.20|-0.34|0.630
72435258|NCT01670110|144383410|SUPERIORITY|||||||0.28|||||||t-test, 2 sided|||Vitality||||0.28
72435259|NCT01670110|144383410|SUPERIORITY|||||||0.66|||||||t-test, 2 sided|||Social functioning||||0.66
72435260|NCT01670110|144383410|SUPERIORITY|||||||0.43|||||||t-test, 2 sided|||Role emotional||||0.43
72435261|NCT01670110|144383410|SUPERIORITY|||||||0.51|||||||t-test, 2 sided|||Mental health||||0.51
72494244|NCT01077973|144517412|SUPERIORITY_OR_OTHER||LS mean difference|-0.1||||0.393|TWO_SIDED|95.0|-0.32|0.13||p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||2 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.13|-0.32|0.393
72494245|NCT01077973|144517412|SUPERIORITY_OR_OTHER||LS mean difference|-0.14||||0.382|TWO_SIDED|95.0|-0.46|0.18||p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||3 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.18|-0.46|0.382
72494246|NCT01077973|144517412|SUPERIORITY_OR_OTHER||LS mean difference|0.0||||0.995|TWO_SIDED|95.0|-0.32|0.32||p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||3 hours: Treatment difference \[Ibuprofen (Motrin IB) - placebo\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.32|-0.32|0.995
72494247|NCT01077973|144517412|SUPERIORITY_OR_OTHER||LS mean difference|-0.14||||0.287|TWO_SIDED|95.0|-0.41|0.12||p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||3 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.12|-0.41|0.287
72494248|NCT01077973|144517413|SUPERIORITY_OR_OTHER||LS mean difference|-0.3||||0.377|TWO_SIDED|95.0|-0.98|0.37||p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1 hour: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.37|-0.98|0.377
72494249|NCT01077973|144517413|SUPERIORITY_OR_OTHER||LS mean difference|-0.34||||0.324|TWO_SIDED|95.0|-1.01|0.34||p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1 hour: Treatment difference \[Ibuprofen (Motrin IB) - placebo\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.34|-1.01|0.324
72494250|NCT01077973|144517413|SUPERIORITY_OR_OTHER||LS mean difference|0.03||||0.902|TWO_SIDED|95.0|-0.52|0.59||p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1 hour: Treatment difference \[Ibuprofen sodium - Ibuprofen (Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.59|-0.52|0.902
72494251|NCT01077973|144517413|SUPERIORITY_OR_OTHER||LS mean difference|-0.42||||0.273|TWO_SIDED|95.0|-1.17|0.33||p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||2 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.33|-1.17|0.273
72494252|NCT01077973|144517413|SUPERIORITY_OR_OTHER||LS mean difference|-0.19||||0.616|TWO_SIDED|95.0|-0.94|0.56||p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||2 hours: Treatment difference \[Ibuprofen (Motrin IB) - placebo\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.56|-0.94|0.616
72494253|NCT01077973|144517413|SUPERIORITY_OR_OTHER||LS mean difference|-0.23||||0.471|TWO_SIDED|95.0|-0.85|0.39||p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||2 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.39|-0.85|0.471
72494254|NCT01077973|144517413|SUPERIORITY_OR_OTHER||LS mean difference|-0.4||||0.356|TWO_SIDED|95.0|-1.24|0.45||p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||3 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.45|-1.24|0.356
72494255|NCT01077973|144517413|SUPERIORITY_OR_OTHER||LS mean difference|-0.15||||0.722|TWO_SIDED|95.0|-1.0|0.69||p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||3 hours: Treatment difference \[Ibuprofen (Motrin IB) - placebo\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.69|-1.00|0.722
72494256|NCT01077973|144517413|SUPERIORITY_OR_OTHER||LS mean difference|-0.24||||0.493|TWO_SIDED|95.0|-0.94|0.46||p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||3 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.46|-0.94|0.493
72494257|NCT01077973|144517414|SUPERIORITY_OR_OTHER||LS mean difference|-0.27||||0.259|TWO_SIDED|95.0|-0.75|0.2||p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPID 0-2: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.20|-0.75|0.259
72494258|NCT01077973|144517414|SUPERIORITY_OR_OTHER||LS mean difference|-0.21||||0.378|TWO_SIDED|95.0|-0.69|0.26||p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPID 0-2: Treatment difference \[Ibuprofen (Motrin IB) - placebo\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.26|-0.69|0.378
72557970|NCT00205777|144645474|SUPERIORITY_OR_OTHER|||||||0.65|TWO_SIDED||||||ANOVA|||Change at Month 12 in QUALEFFO: P value was calculated using ANOVA.||||0.65
72557971|NCT00205777|144645474|SUPERIORITY_OR_OTHER|||||||0.18|TWO_SIDED||||||ANOVA|||Change at Month 12 in QUALEFFO: P value was calculated using ANOVA.||||0.18
72557972|NCT00205777|144645474|SUPERIORITY_OR_OTHER|||||||0.36|TWO_SIDED||||||ANOVA|||Change at Month 12 in QUALEFFO: P value was calculated using ANOVA.||||0.36
72557973|NCT00205777|144645474|SUPERIORITY_OR_OTHER|||||||0.27||95.0|||||ANOVA|||Change at Month 24 in QUALEFFO: P value was calculated using ANOVA.||||0.27
72557974|NCT00205777|144645474|SUPERIORITY_OR_OTHER|||||||0.25||95.0|||||ANOVA|||Change at Month 24 in QUALEFFO: P value was calculated using ANOVA.||||0.25
72557975|NCT00205777|144645474|SUPERIORITY_OR_OTHER|||||||0.053||95.0|||||ANOVA|||Change at Month 24 in QUALEFFO: P value was calculated using ANOVA.||||0.053
72557976|NCT00205777|144645474|SUPERIORITY_OR_OTHER|||||||0.4||95.0|||||ANOVA|||Change at Month 24 in QUALEFFO: P value was calculated using ANOVA.||||0.40
72557977|NCT00205777|144645474|SUPERIORITY_OR_OTHER|||||||0.45||95.0|||||ANOVA|||Change at Month 24 in QUALEFFO: P value was calculated using ANOVA.||||0.45
72557978|NCT00205777|144645474|SUPERIORITY_OR_OTHER|||||||0.012||95.0|||||ANOVA|||Change at Month 36 in QUALEFFO: P value was calculated using ANOVA.||||0.012
72557979|NCT00205777|144645474|SUPERIORITY_OR_OTHER|||||||0.54||95.0|||||ANOVA|||Change at Month 36 in QUALEFFO: P value was calculated using ANOVA.||||0.54
72557980|NCT00205777|144645474|SUPERIORITY_OR_OTHER|||||||0.11||95.0|||||ANOVA|||Change at Month 36 in QUALEFFO: P value was calculated using ANOVA.||||0.11
72557981|NCT00205777|144645474|SUPERIORITY_OR_OTHER|||||||0.35||95.0|||||ANOVA|||Change at Month 36 in QUALEFFO: P value was calculated using ANOVA.||||0.35
72557982|NCT00205777|144645474|SUPERIORITY_OR_OTHER|||||||0.34||95.0|||||ANOVA|||Change at Month 36 in QUALEFFO: P value was calculated using ANOVA.||||0.34
72557983|NCT00205777|144645476|SUPERIORITY_OR_OTHER|||||||0.21|TWO_SIDED||||||ANOVA|||Change at Month 12 in EQ-5D VAS: P value was calculated using ANOVA.||||0.21
72557984|NCT00205777|144645476|SUPERIORITY_OR_OTHER|||||||0.058|TWO_SIDED||||||ANOVA|||Change at Month 12 in EQ-5D VAS: P value was calculated using ANOVA.||||0.058
72383339|NCT00809354|144275216|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.84|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|95.0|-1.2|0.48|||ANCOVA|||Change at Week 16: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.48|-1.20|<0.001
72557985|NCT00205777|144645476|SUPERIORITY_OR_OTHER|||||||0.76|TWO_SIDED||||||ANOVA|||Change at Month 12 in EQ-5D VAS: P value was calculated using ANOVA.||||0.76
72557986|NCT00205777|144645476|SUPERIORITY_OR_OTHER|||||||0.34|TWO_SIDED||||||ANOVA|||Change at Month 12 in EQ-5D VAS: P value was calculated using ANOVA.||||0.34
72557987|NCT00205777|144645476|SUPERIORITY_OR_OTHER|||||||0.51|TWO_SIDED||||||ANOVA|||Change at Month 12 in EQ-5D VAS: P value was calculated using ANOVA.||||0.51
72557988|NCT00205777|144645476|SUPERIORITY_OR_OTHER|||||||0.14||95.0|||||ANOVA|||Change at Month 24 in EQ-5D VAS: P value was calculated using ANOVA.||||0.14
72557989|NCT00205777|144645476|SUPERIORITY_OR_OTHER|||||||0.57||95.0|||||ANOVA|||Change at Month 24 in EQ-5D VAS: P value was calculated using ANOVA.||||0.57
72557990|NCT00205777|144645476|SUPERIORITY_OR_OTHER|||||||0.78||95.0|||||ANOVA|||Change at Month 24 in EQ-5D VAS: P value was calculated using ANOVA.||||0.78
72557991|NCT00205777|144645476|SUPERIORITY_OR_OTHER|||||||0.24||95.0|||||ANOVA|||Change at Month 24 in EQ-5D VAS: P value was calculated using ANOVA.||||0.24
72557992|NCT00205777|144645476|SUPERIORITY_OR_OTHER|||||||0.78||95.0|||||ANOVA|||Change at Month 24 in EQ-5D VAS: P value was calculated using ANOVA.||||0.78
72557993|NCT00205777|144645476|SUPERIORITY_OR_OTHER|||||||0.62||95.0|||||ANOVA|||Change at Month 36 in EQ-5D VAS: P value was calculated using ANOVA.||||0.62
72557994|NCT00205777|144645476|SUPERIORITY_OR_OTHER|||||||0.72||95.0|||||ANOVA|||Change at Month 36 in EQ-5D VAS: P value was calculated using ANOVA.||||0.72
72557995|NCT00205777|144645476|SUPERIORITY_OR_OTHER|||||||0.16||95.0|||||ANOVA|||Change at Month 36 in EQ-5D VAS: P value was calculated using ANOVA.||||0.16
72557996|NCT00205777|144645476|SUPERIORITY_OR_OTHER|||||||0.059||95.0|||||ANOVA|||Change at Month 36 in EQ-5D VAS: P value was calculated using ANOVA.||||0.059
72557997|NCT00205777|144645476|SUPERIORITY_OR_OTHER|||||||0.3||95.0|||||ANOVA|||Change at Month 36 in EQ-5D VAS: P value was calculated using ANOVA.||||0.30
72557998|NCT00205777|144645478|SUPERIORITY_OR_OTHER|||||||0.72||95.0|||||ANOVA|||Change at Month 12 in EQ-5D: P value was calculated using ANOVA.||||0.72
72557999|NCT00205777|144645478|SUPERIORITY_OR_OTHER|||||||0.98||95.0|||||ANOVA|||Change at Month 12 in EQ-5D: P value was calculated using ANOVA.||||0.98
72558000|NCT00205777|144645478|SUPERIORITY_OR_OTHER|||||||0.84||95.0|||||ANOVA|||Change at Month 12 in EQ-5D: P value was calculated using ANOVA.||||0.84
72558001|NCT00205777|144645478|SUPERIORITY_OR_OTHER|||||||0.88||95.0|||||ANOVA|||Change at Month 12 in EQ-5D: P value was calculated using ANOVA.||||0.88
72558002|NCT00205777|144645478|SUPERIORITY_OR_OTHER|||||||0.86||95.0|||||ANOVA|||Change at Month 12 in EQ-5D: P value was calculated using ANOVA.||||0.86
72558003|NCT00205777|144645478|SUPERIORITY_OR_OTHER|||||||0.82||95.0|||||ANOVA|||Change at Month 24 in EQ-5D: P value was calculated using ANOVA.||||0.82
72558004|NCT00205777|144645478|SUPERIORITY_OR_OTHER|||||||0.11||95.0|||||ANOVA|||Change at Month 24 in EQ-5D: P value was calculated using ANOVA.||||0.11
72558005|NCT00205777|144645478|SUPERIORITY_OR_OTHER|||||||0.14||95.0|||||ANOVA|||Change at Month 24 in EQ-5D: P value was calculated using ANOVA.||||0.14
72558006|NCT00205777|144645478|SUPERIORITY_OR_OTHER|||||||0.22||95.0|||||ANOVA|||Change at Month 24 in EQ-5D: P value was calculated using ANOVA.||||0.22
72558007|NCT00205777|144645478|SUPERIORITY_OR_OTHER|||||||0.88||95.0|||||ANOVA|||Change at Month 24 in EQ-5D: P value was calculated using ANOVA.||||0.88
72558008|NCT00205777|144645478|SUPERIORITY_OR_OTHER|||||||0.96||95.0|||||ANOVA|||Change at Month 36 in EQ-5D: P value was calculated using ANOVA.||||0.96
72558009|NCT00205777|144645478|SUPERIORITY_OR_OTHER|||||||0.76||95.0|||||ANOVA|||Change at Month 36 in EQ-5D: P value was calculated using ANOVA.||||0.76
72558010|NCT00205777|144645478|SUPERIORITY_OR_OTHER|||||||0.92||95.0|||||ANOVA|||Change at Month 36 in EQ-5D: P value was calculated using ANOVA.||||0.92
72383340|NCT00809354|144275216|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-1.12|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|95.0|-1.48|-0.76|||ANCOVA|||Change at Week 16: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.76|-1.48|<0.001
72558011|NCT00205777|144645478|SUPERIORITY_OR_OTHER|||||||0.89||95.0|||||ANOVA|||Change at Month 36 in EQ-5D: P value was calculated using ANOVA.||||0.89
72383341|NCT00809354|144275216|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.15|STANDARD_ERROR_OF_MEAN|0.18||0.408|TWO_SIDED|95.0|-0.51|0.21|||ANCOVA|||Change at Week 16: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.21|-0.51|0.408
72383342|NCT00809354|144275216|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.31|STANDARD_ERROR_OF_MEAN|0.18||0.097|TWO_SIDED|95.0|-0.67|0.06|||ANCOVA|||Change at Week 16: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.06|-0.67|0.097
72383343|NCT00809354|144275216|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.43|STANDARD_ERROR_OF_MEAN|0.18||0.018|TWO_SIDED|95.0|-0.79|-0.07|||ANCOVA|||Change at Week 16: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.07|-0.79|0.018
72383344|NCT00809354|144275216|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.28|STANDARD_ERROR_OF_MEAN|0.18||0.132|TWO_SIDED|95.0|-0.64|0.08|||ANCOVA|||Change at Week 16: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.08|-0.64|0.132
72383345|NCT00809354|144275216|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.67|STANDARD_ERROR_OF_MEAN|0.21||0.001|TWO_SIDED|95.0|-1.08|-0.26|||ANCOVA|||Change at Week 16: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates||-0.26|-1.08|0.001
72383346|NCT00809354|144275216|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.66|STANDARD_ERROR_OF_MEAN|0.21||0.002|TWO_SIDED|95.0|-1.07|-0.25|||ANCOVA|||Change at Week 16: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates||-0.25|-1.07|0.002
72383347|NCT00809354|144275216|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.78|STANDARD_ERROR_OF_MEAN|0.21|<|0.001|TWO_SIDED|95.0|-1.19|-0.37|||ANCOVA|||Change at Week 16: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates||-0.37|-1.19|<0.001
72383348|NCT00809354|144275216|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.96|STANDARD_ERROR_OF_MEAN|0.21|<|0.001|TWO_SIDED|95.0|-1.37|-0.55|||ANCOVA|||Change at Week 16: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates||-0.55|-1.37|<0.001
72383349|NCT00809354|144275216|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.21||0.959|TWO_SIDED|95.0|-0.4|0.42|||ANCOVA|||Change at Week 16: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates||0.42|-0.40|0.959
72383350|NCT00809354|144275216|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.21||0.618|TWO_SIDED|95.0|-0.51|0.31|||ANCOVA|||Change at Week 16: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates||0.31|-0.51|0.618
72383351|NCT00809354|144275216|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.21||0.149|TWO_SIDED|95.0|-0.71|0.11|||ANCOVA|||Change at Week 16: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates||0.11|-0.71|0.149
72383352|NCT00809354|144275216|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.21||0.37|TWO_SIDED|95.0|-0.6|0.22|||ANCOVA|||Change at Week 16: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates||0.22|-0.60|0.370
72383353|NCT00809354|144275217|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.02|STANDARD_ERROR_OF_MEAN|0.16||0.887|TWO_SIDED|95.0|-0.33|0.28|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.28|-0.33|0.887
72383354|NCT00809354|144275217|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.31|STANDARD_ERROR_OF_MEAN|0.16||0.046|TWO_SIDED|95.0|-0.62|-0.01|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.01|-0.62|0.046
72383355|NCT00809354|144275217|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.05|STANDARD_ERROR_OF_MEAN|0.16||0.771|TWO_SIDED|95.0|-0.26|0.35|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.35|-0.26|0.771
72383356|NCT00809354|144275217|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.34|STANDARD_ERROR_OF_MEAN|0.16||0.032|TWO_SIDED|95.0|0.03|0.64|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.64|0.03|0.032
72383357|NCT00809354|144275217|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.21|STANDARD_ERROR_OF_MEAN|0.17||0.223|TWO_SIDED|95.0|-0.13|0.54|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.54|-0.13|0.223
72383358|NCT00809354|144275217|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.06|STANDARD_ERROR_OF_MEAN|0.17||0.718|TWO_SIDED|95.0|-0.39|0.27|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.27|-0.39|0.718
72383359|NCT00809354|144275217|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.12|STANDARD_ERROR_OF_MEAN|0.17||0.495|TWO_SIDED|95.0|-0.45|0.22|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.22|-0.45|0.495
72383360|NCT00809354|144275217|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.15|STANDARD_ERROR_OF_MEAN|0.17||0.371|TWO_SIDED|95.0|-0.18|0.49|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.49|-0.18|0.371
72383361|NCT00809354|144275217|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.08|STANDARD_ERROR_OF_MEAN|0.16||0.647|TWO_SIDED|95.0|-0.4|0.25|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.25|-0.40|0.647
72383362|NCT00809354|144275217|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.16||0.073|TWO_SIDED|95.0|-0.62|0.03|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.03|-0.62|0.073
72383363|NCT00809354|144275217|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.23|STANDARD_ERROR_OF_MEAN|0.16||0.161|TWO_SIDED|95.0|-0.55|0.09|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.09|-0.55|0.161
72435262|NCT01768676|144383422|NON_INFERIORITY_OR_EQUIVALENCE|The difference in percentage of subjects with a \>/= 50% reduction from baseline to Week 26 in sperm concentration between treatment arms was analyzed using Cochran-Mantel-Haenszel method to account for the randomization stratification by baseline sperm concentration. If upper limit of 95% CI \< 20% then avanafil is considered non-inferior to placebo.|Risk Difference (RD)|-12.93|STANDARD_ERROR_OF_MEAN|4.41|||TWO_SIDED|95.0|-21.56|-4.29|||||Confidence interval was only calculated for primary endpoint of the difference between avanafil and placebo, not for each individual arm.|||-4.29|-21.56|
72435263|NCT01768676|144383423|NON_INFERIORITY_OR_EQUIVALENCE|If upper limit of 95% CI \< 20% then avanafil is considered non-inferior to placebo.|Risk Difference (RD)|-11.4|STANDARD_ERROR_OF_MEAN|6.2|||TWO_SIDED|95.0|-23.5|0.7|||||Confidence interval was only calculated for primary endpoint of the difference between avanafil and placebo, not for each individual arm.|||0.7|-23.5|
72435264|NCT01768676|144383424|NON_INFERIORITY_OR_EQUIVALENCE|If upper limit of 95% CI \< 20% then avanafil is considered non-inferior to placebo.|Risk Difference (RD)|-1.4|STANDARD_ERROR_OF_MEAN|1.4|||TWO_SIDED|95.0|-4.2|1.3|||||Confidence interval was only calculated for primary endpoint of the difference between avanafil and placebo, not for each individual arm.|||1.3|-4.2|
72618724|NCT01026038|144768109|SUPERIORITY_OR_OTHER||GMT ratio|1.3|||||TWO_SIDED|95.0|0.98|1.63||||||Serotype 9V: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||1.63|0.98|
72383364|NCT00809354|144275217|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.01|STANDARD_ERROR_OF_MEAN|0.16||0.961|TWO_SIDED|95.0|-0.33|0.32|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.32|-0.33|0.961
72383365|NCT00809354|144275217|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.07|STANDARD_ERROR_OF_MEAN|0.18||0.697|TWO_SIDED|95.0|-0.42|0.28|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.28|-0.42|0.697
72383366|NCT00809354|144275217|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.27|STANDARD_ERROR_OF_MEAN|0.18||0.139|TWO_SIDED|95.0|-0.62|0.09|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.09|-0.62|0.139
72383367|NCT00809354|144275217|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.28|STANDARD_ERROR_OF_MEAN|0.18||0.12|TWO_SIDED|95.0|-0.64|0.07|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.07|-0.64|0.120
72383368|NCT00809354|144275217|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.09|STANDARD_ERROR_OF_MEAN|0.18||0.637|TWO_SIDED|95.0|-0.44|0.27|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.27|-0.44|0.637
72383369|NCT00809354|144275217|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.38|STANDARD_ERROR_OF_MEAN|0.17||0.028|TWO_SIDED|95.0|-0.72|-0.04|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.04|-0.72|0.028
72383370|NCT00809354|144275217|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.39|STANDARD_ERROR_OF_MEAN|0.17||0.024|TWO_SIDED|95.0|-0.74|-0.05|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.05|-0.74|0.024
72383371|NCT00809354|144275217|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.17|STANDARD_ERROR_OF_MEAN|0.17||0.339|TWO_SIDED|95.0|-0.51|0.17|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.17|-0.51|0.339
72383372|NCT00809354|144275217|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.15|STANDARD_ERROR_OF_MEAN|0.17||0.381|TWO_SIDED|95.0|-0.5|0.19|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.19|-0.50|0.381
72383373|NCT00809354|144275217|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.14|STANDARD_ERROR_OF_MEAN|0.19||0.438|TWO_SIDED|95.0|-0.51|0.22|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.22|-0.51|0.438
72383374|NCT00809354|144275217|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.19||0.111|TWO_SIDED|95.0|-0.66|0.07|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.07|-0.66|0.111
72383375|NCT00809354|144275217|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.35|STANDARD_ERROR_OF_MEAN|0.19||0.059|TWO_SIDED|95.0|-0.72|0.01|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.01|-0.72|0.059
72383376|NCT00809354|144275217|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.19||0.282|TWO_SIDED|95.0|-0.57|0.17|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.17|-0.57|0.282
72383377|NCT00809354|144275217|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.02|STANDARD_ERROR_OF_MEAN|0.18||0.927|TWO_SIDED|95.0|-0.37|0.33|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.33|-0.37|0.927
72383378|NCT00809354|144275217|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.18||0.094|TWO_SIDED|95.0|-0.65|0.05|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.05|-0.65|0.094
72383379|NCT00809354|144275217|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.45|STANDARD_ERROR_OF_MEAN|0.18||0.012|TWO_SIDED|95.0|-0.8|-0.1|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.10|-0.80|0.012
72383380|NCT00809354|144275217|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.16|STANDARD_ERROR_OF_MEAN|0.18||0.363|TWO_SIDED|95.0|-0.51|0.19|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.19|-0.51|0.363
72383381|NCT00809354|144275217|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.06|STANDARD_ERROR_OF_MEAN|0.2||0.742|TWO_SIDED|95.0|-0.32|0.45|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.45|-0.32|0.742
72558012|NCT00205777|144645478|SUPERIORITY_OR_OTHER|||||||0.83||95.0|||||ANOVA|||Change at Month 36 in EQ-5D: P value was calculated using ANOVA.||||0.83
72618725|NCT01026038|144768109|SUPERIORITY_OR_OTHER||GMT ratio|1.0|||||TWO_SIDED|95.0|0.76|1.27||||||Serotype 9V: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.27|0.76|
72558013|NCT03703258|144645485|SUPERIORITY||Slope|0.14|STANDARD_ERROR_OF_MEAN|0.26||0.6|TWO_SIDED||||||Mixed Models Analysis||Condition x time interaction coefficient from mixed-effect model using negative binomial distribution. Intervention = 1 and control = 0.|||||.60
72618726|NCT01026038|144768109|SUPERIORITY_OR_OTHER||GMT ratio|0.8|||||TWO_SIDED|95.0|0.58|1.05||||||Serotype 9V: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.05|0.58|
72383382|NCT00809354|144275217|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.15|STANDARD_ERROR_OF_MEAN|0.19||0.436|TWO_SIDED|95.0|-0.53|0.23|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.23|-0.53|0.436
72383383|NCT00809354|144275217|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.41|STANDARD_ERROR_OF_MEAN|0.2||0.038|TWO_SIDED|95.0|-0.79|-0.02|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.02|-0.79|0.038
72383384|NCT00809354|144275217|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.19|STANDARD_ERROR_OF_MEAN|0.2||0.332|TWO_SIDED|95.0|-0.57|0.19|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.19|-0.57|0.332
72383385|NCT00809354|144275217|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.16||0.284|TWO_SIDED|95.0|-0.47|0.14|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.14|-0.47|0.284
72383386|NCT00809354|144275217|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.16||0.224|TWO_SIDED|95.0|-0.5|0.12|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.12|-0.50|0.224
72383387|NCT00809354|144275217|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.48|STANDARD_ERROR_OF_MEAN|0.16||0.002|TWO_SIDED|95.0|-0.79|-0.17|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.17|-0.79|0.002
72383388|NCT00809354|144275217|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.16||0.355|TWO_SIDED|95.0|-0.45|0.16|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.16|-0.45|0.355
72383389|NCT00809354|144275217|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.23|STANDARD_ERROR_OF_MEAN|0.17||0.172|TWO_SIDED|95.0|-0.57|0.1|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.10|-0.57|0.172
72383390|NCT00809354|144275217|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.17||0.882|TWO_SIDED|95.0|-0.36|0.31|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.31|-0.36|0.882
72383391|NCT00809354|144275217|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.29|STANDARD_ERROR_OF_MEAN|0.17||0.084|TWO_SIDED|95.0|-0.63|0.04|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.04|-0.63|0.084
72383392|NCT00809354|144275217|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.17||0.405|TWO_SIDED|95.0|-0.47|0.19|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.19|-0.47|0.405
72383393|NCT00809354|144275217|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.67|STANDARD_ERROR_OF_MEAN|0.16|<|0.001|TWO_SIDED|95.0|-0.99|-0.34|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.34|-0.99|<0.001
72383394|NCT00809354|144275217|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.74|STANDARD_ERROR_OF_MEAN|0.16|<|0.001|TWO_SIDED|95.0|-1.06|-0.42|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.42|-1.06|<0.001
72383395|NCT00809354|144275217|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.96|STANDARD_ERROR_OF_MEAN|0.16|<|0.001|TWO_SIDED|95.0|-1.29|-0.64|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.64|-1.29|<0.001
72383396|NCT00809354|144275217|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.97|STANDARD_ERROR_OF_MEAN|0.16|<|0.001|TWO_SIDED|95.0|-1.29|-0.65|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.65|-1.29|<0.001
72383397|NCT00809354|144275217|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|95.0|-0.95|-0.25|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.25|-0.95|<0.001
72383398|NCT00809354|144275217|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.67|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|95.0|-1.02|-0.32|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.32|-1.02|<0.001
72383399|NCT00809354|144275217|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.87|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|95.0|-1.22|-0.51|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.51|-1.22|<0.001
72383400|NCT00809354|144275217|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.95|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|95.0|-1.31|-0.6|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.60|-1.31|<0.001
72383401|NCT00809354|144275217|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.52|STANDARD_ERROR_OF_MEAN|0.17||0.003|TWO_SIDED|95.0|-0.86|-0.18|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.18|-0.86|0.003
72383402|NCT00809354|144275217|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|0.17|<|0.001|TWO_SIDED|95.0|-1.24|-0.56|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.56|-1.24|<0.001
72383403|NCT00809354|144275217|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.92|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|95.0|-1.26|-0.57|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.57|-1.26|<0.001
72618727|NCT01026038|144768109|SUPERIORITY_OR_OTHER||GMT ratio|0.9|||||TWO_SIDED|95.0|0.67|1.21||||||Serotype 14: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||1.21|0.67|
72383404|NCT00809354|144275217|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.07|STANDARD_ERROR_OF_MEAN|0.17|<|0.001|TWO_SIDED|95.0|-1.41|-0.73|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.73|-1.41|<0.001
72383405|NCT00809354|144275217|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.19|<|0.001|TWO_SIDED|95.0|-1.06|-0.33|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.33|-1.06|<0.001
72383406|NCT00809354|144275217|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.84|STANDARD_ERROR_OF_MEAN|0.19|<|0.001|TWO_SIDED|95.0|-1.21|-0.47|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.47|-1.21|<0.001
72383407|NCT00809354|144275217|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.99|STANDARD_ERROR_OF_MEAN|0.19|<|0.001|TWO_SIDED|95.0|-1.36|-0.63|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.63|-1.36|<0.001
72383408|NCT00809354|144275217|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.19|STANDARD_ERROR_OF_MEAN|0.19|<|0.001|TWO_SIDED|95.0|-1.56|-0.83|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.83|-1.56|<0.001
72383409|NCT00809354|144275217|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.58|STANDARD_ERROR_OF_MEAN|0.18||0.001|TWO_SIDED|95.0|-0.93|-0.23|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.23|-0.93|0.001
72383410|NCT00809354|144275217|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.88|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|95.0|-1.24|-0.53|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.53|-1.24|<0.001
72383411|NCT00809354|144275217|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.88|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|95.0|-1.24|-0.53|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.53|-1.24|<0.001
72383412|NCT00809354|144275217|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.05|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|95.0|-1.4|-0.7|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.70|-1.40|<0.001
72383413|NCT00809354|144275217|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.79|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|-1.17|-0.4|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.40|-1.17|<0.001
72383414|NCT00809354|144275217|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.72|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|-1.11|-0.34|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.34|-1.11|<0.001
72383415|NCT00809354|144275217|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.94|STANDARD_ERROR_OF_MEAN|0.19|<|0.001|TWO_SIDED|95.0|-1.32|-0.56|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.56|-1.32|<0.001
72383416|NCT00809354|144275217|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.13|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|-1.51|-0.75|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.75|-1.51|<0.001
72383417|NCT00809354|144275218|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.16||0.887|TWO_SIDED|95.0|-0.33|0.28|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.28|-0.33|0.887
72383418|NCT00809354|144275218|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.31|STANDARD_ERROR_OF_MEAN|0.16||0.046|TWO_SIDED|95.0|-0.62|-0.01|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.01|-0.62|0.046
72383419|NCT00809354|144275218|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.05|STANDARD_ERROR_OF_MEAN|0.16||0.771|TWO_SIDED|95.0|-0.26|0.35|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.35|-0.26|0.771
72383420|NCT00809354|144275218|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.34|STANDARD_ERROR_OF_MEAN|0.16||0.032|TWO_SIDED|95.0|0.03|0.64|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.64|0.03|0.032
72383421|NCT00809354|144275218|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.21|STANDARD_ERROR_OF_MEAN|0.17||0.223|TWO_SIDED|95.0|-0.13|0.54|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.54|-0.13|0.223
72383422|NCT00809354|144275218|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.06|STANDARD_ERROR_OF_MEAN|0.17||0.718|TWO_SIDED|95.0|-0.39|0.27|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.27|-0.39|0.718
72383423|NCT00809354|144275218|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.12|STANDARD_ERROR_OF_MEAN|0.17||0.495|TWO_SIDED|95.0|-0.45|0.22|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.22|-0.45|0.495
72383424|NCT00809354|144275218|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.14|STANDARD_ERROR_OF_MEAN|0.16||0.389|TWO_SIDED|95.0|-0.47|0.18|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.18|-0.47|0.389
72383425|NCT00809354|144275218|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.35|STANDARD_ERROR_OF_MEAN|0.17||0.035|TWO_SIDED|95.0|-0.68|-0.02|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.02|-0.68|0.035
72435265|NCT01768676|144383425|NON_INFERIORITY_OR_EQUIVALENCE|If upper limit of 95% CI \< 20% then avanafil is considered non-inferior to placebo.|Risk Difference (RD)|-2.9|STANDARD_ERROR_OF_MEAN|2.0|||TWO_SIDED|95.0|-6.8|1.1|||||Confidence interval was only calculated for primary endpoint of the difference between avanafil and placebo, not for each individual arm.|||1.1|-6.8|
72435266|NCT01768676|144383426|NON_INFERIORITY_OR_EQUIVALENCE|If upper limit of 95% CI \< 20% then avanafil is considered non-inferior to placebo.|Risk Difference (RD)|0.0|STANDARD_ERROR_OF_MEAN|0.0|||TWO_SIDED|95.0|0.0|0.0|||||Confidence interval was only calculated for primary endpoint of the difference between avanafil and placebo, not for each individual arm.|||0|0|
72435267|NCT03693742|144383447|SUPERIORITY||||||<|0.001||||||A P value of less than 0.05 was considered significant.|Mixed Models Analysis|||"Null hypothesis is that there was no difference in uptake of F18-DCFPyL between the MSG and placebo groups.~A sample size of 10 achieves 100% power to detect a mean of paired differences of 5.0 (33%) with an estimated standard deviation of differences of 1.0 and with a significance level (alpha) of 0.05 using a one-sided paired t-test. If the estimated standard deviation of differences is 5.0, a sample size of 10 achieves 90% power to detect a mean difference of 5.0 with an alpha of 0.05."||||<0.001
72618728|NCT01026038|144768109|SUPERIORITY_OR_OTHER||GMT ratio|0.9|||||TWO_SIDED|95.0|0.7|1.25||||||Serotype 14: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.25|0.70|
72383426|NCT00809354|144275218|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.23|STANDARD_ERROR_OF_MEAN|0.16||0.155|TWO_SIDED|95.0|-0.56|0.09|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.09|-0.56|0.155
72383427|NCT00809354|144275218|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.03|STANDARD_ERROR_OF_MEAN|0.17||0.876|TWO_SIDED|95.0|-0.35|0.3|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.30|-0.35|0.876
72383428|NCT00809354|144275218|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.03|STANDARD_ERROR_OF_MEAN|0.18||0.864|TWO_SIDED|95.0|-0.33|0.39|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.39|-0.33|0.864
72435268|NCT03068468|144383501|SUPERIORITY||Difference|-0.2||||0.8483|TWO_SIDED|95.0|-2.0|1.6|||Mixed model for repeated measures (MMRM)|||28-item:Adjusted mean for each treatment group, difference with Placebo,95% confidence interval and p-value at each time point were based on a mixed model for repeated measures model (MMRM), with change from baseline in 28-item PSPRS total score as dependent variable and with fixed effects of treatment group, time(categorical), treatment group-by-time interaction, baseline 28-item PSPRS, baseline 28-item PSPRS by time interaction, baseline Color Trails 2 test (\<=170 or \>170 seconds) and region.||1.6|-2.0|0.8483
72435269|NCT03068468|144383501|SUPERIORITY||Difference|-0.28||||0.6503|TWO_SIDED|95.0|-1.5|0.94|||MMRM|||15-items:Adjusted mean for each treatment group, difference with Placebo,95% confidence interval and p-value at each time point were based on an MMRM model, with change from baseline in 15-item PSPRS total score as dependent variable and with fixed effects of treatment group, time(categorical), treatment groupby-time interaction, baseline 15-item PSPRS, baseline 15-item PSPRS by time interaction, baseline Color Trails 2 test(\<=170 or \>170 seconds) and region.||0.94|-1.50|0.6503
72435270|NCT03068468|144383503|SUPERIORITY||Difference|0.4||||0.6031|TWO_SIDED|95.0|-1.0|1.7|||MMRM|||Adjusted mean for each treatment group, difference with Placebo, 95% confidence interval and p-value at each time point were based on an MMRM model, with change from baseline in MDS-UPDRS as dependent variable and with fixed effects of treatment group, time (categorical), treatment group-by-time interaction, baseline MDS-UPDRS, baseline MDS-UPDRS by time interaction, baseline Color Trails 2 test (\<=170 or \>170 seconds) and region.||1.7|-1.0|0.6031
72435271|NCT03068468|144383504|SUPERIORITY||Difference|0.0||||0.7743|TWO_SIDED|95.0|-0.2|0.1|||MMRM|||Adjusted mean for each treatment group, difference with Placebo, 95% confidence interval and p-value at each time point were based on an MMRM model, with CGI-C as dependent variable and with fixed effects of treatment group, time (categorical), treatment group-by-time interaction, baseline CGI-S, baseline CGI-S by time interaction, baseline Color Trails 2 test (\<=170 or \>170 seconds) and region.||0.1|-0.2|0.7743
72435272|NCT03068468|144383505|SUPERIORITY||Difference|0.038||||0.318|TWO_SIDED|95.0|-0.036|0.112|||MMRM|||Adjusted mean for each treatment group, difference with Placebo, 95% confidence interval and p-value at each time point were based on an MMRM model, with change from baseline in PSP-cognitive composite battery as dependent variable and with fixed effects of treatment group, time (categorical), treatment group-by-time interaction, baseline PSP-cognitive composite battery, baseline PSP-cognitive composite battery by time interaction, baseline Color Trails 2 test (\<=170 or \>170 seconds) and region.||0.112|-0.036|0.3180
72435273|NCT03068468|144383506|SUPERIORITY||Difference|-0.2||||0.827|TWO_SIDED|95.0|-1.8|1.4|||MMRM|||Adjusted mean for each treatment group, difference with Placebo, 95% confidence interval and p-value at each time point were based on an MMRM model, with change from baseline in RBANS as dependent variable and with fixed effects of treatment group, time (categorical), treatment group-by-time interaction, baseline RBANS , baseline RBANS by time interaction, baseline Color Trails 2 test (\<=170 or \>170 seconds and region.||1.4|-1.8|0.8270
72435274|NCT03068468|144383507|SUPERIORITY||Difference|-0.2||||0.9304|TWO_SIDED|95.0|-3.6|3.3|||MMRM|||Physical scale score: Adjusted mean for each treatment group, difference with Placebo, 95% confidence interval and p-value at each time point were based on an MMRM model, with change from baseline in PSP-QoL as dependent variable and with fixed effects of treatment group, time (categorical), treatment group-by-time interaction, baseline for PSP-QoL, baseline PSP-QoL by time interaction, baseline Color Trails 2 test (\<=170 or \>170 seconds) and region.||3.3|-3.6|0.9304
72494259|NCT01077973|144517414|SUPERIORITY_OR_OTHER||LS mean difference|-0.06||||0.762|TWO_SIDED|95.0|-0.45|0.33||p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPID 0-2: Treatment difference \[Ibuprofen sodium - Ibuprofen (Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.33|-0.45|0.762
72618729|NCT01026038|144768109|SUPERIORITY_OR_OTHER||GMT ratio|1.0|||||TWO_SIDED|95.0|0.73|1.46||||||Serotype 14: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.46|0.73|
72558014|NCT03703258|144645485|SUPERIORITY||Cohen's D|0.36|||||TWO_SIDED||||||||Between-group Cohen's d; calculated as within-group d(intervention) - within group d(control). Standardized using the standard deviation of the change scores. Negative values favor intervention and positive values favor control.|||||
72558015|NCT03703258|144645486|SUPERIORITY||Slope|-0.02|STANDARD_ERROR_OF_MEAN|0.27||0.94|TWO_SIDED||||||Mixed Models Analysis||Condition x time interaction coefficient from mixed-effect model using negative binomial distribution. Intervention = 1 and control = 0.|||||.94
72383429|NCT00809354|144275218|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.18|STANDARD_ERROR_OF_MEAN|0.18||0.338|TWO_SIDED|95.0|-0.54|0.18|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.18|-0.54|0.338
72383430|NCT00809354|144275218|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.18||0.101|TWO_SIDED|95.0|-0.66|0.06|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.06|-0.66|0.101
72383431|NCT00809354|144275218|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.09|STANDARD_ERROR_OF_MEAN|0.18||0.605|TWO_SIDED|95.0|-0.46|0.27|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.27|-0.46|0.605
72383432|NCT00809354|144275218|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.43|STANDARD_ERROR_OF_MEAN|0.17||0.013|TWO_SIDED|95.0|-0.78|-0.09|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.09|-0.78|0.013
72383433|NCT00809354|144275218|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.18||0.005|TWO_SIDED|95.0|-0.84|-0.15|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.15|-0.84|0.005
72383434|NCT00809354|144275218|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.22|STANDARD_ERROR_OF_MEAN|0.17||0.199|TWO_SIDED|95.0|-0.57|0.12|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.12|-0.57|0.199
72383435|NCT00809354|144275218|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.16|STANDARD_ERROR_OF_MEAN|0.18||0.363|TWO_SIDED|95.0|-0.5|0.18|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.18|-0.50|0.363
72383436|NCT00809354|144275218|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.19||0.613|TWO_SIDED|95.0|-0.47|0.28|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.28|-0.47|0.613
72383437|NCT00809354|144275218|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.16|STANDARD_ERROR_OF_MEAN|0.19||0.416|TWO_SIDED|95.0|-0.53|0.22|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.22|-0.53|0.416
72383438|NCT00809354|144275218|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.28|STANDARD_ERROR_OF_MEAN|0.19||0.143|TWO_SIDED|95.0|-0.66|0.09|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.09|-0.66|0.143
72383439|NCT00809354|144275218|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.22|STANDARD_ERROR_OF_MEAN|0.19||0.245|TWO_SIDED|95.0|-0.6|0.15|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.15|-0.60|0.245
72383440|NCT00809354|144275218|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.06|STANDARD_ERROR_OF_MEAN|0.18||0.745|TWO_SIDED|95.0|-0.41|0.29|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.29|-0.41|0.745
72435275|NCT03068468|144383507|SUPERIORITY||Difference|0.5||||0.7859|TWO_SIDED|95.0|-2.8|3.7|||MMRM|||Mental scale score: Adjusted mean for each treatment group, difference with Placebo, 95% confidence interval and p-value at each time point were based on an MMRM model, with change from baseline in PSPQoL as dependent variable and with fixed effects of treatment group, time (categorical), treatment group-bytime interaction, baseline for PSP-QoL, baseline PSP-QoL by time interaction, baseline Color Trails 2 test (\<=170 or \>170 seconds) and region.||3.7|-2.8|0.7859
72558016|NCT03703258|144645486|SUPERIORITY||Cohen's D|-0.01|||||TWO_SIDED||||||||Between-group Cohen's d; calculated as within-group d(intervention) - within group d(control). Standardized using the standard deviation of the change scores. Negative values favor intervention and positive values favor control.|||||
72383441|NCT00809354|144275218|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.34|STANDARD_ERROR_OF_MEAN|0.18||0.062|TWO_SIDED|95.0|-0.69|0.02|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.02|-0.69|0.062
72383442|NCT00809354|144275218|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.44|STANDARD_ERROR_OF_MEAN|0.18||0.014|TWO_SIDED|95.0|-0.8|-0.09|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.09|-0.80|0.014
72383443|NCT00809354|144275218|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.16|STANDARD_ERROR_OF_MEAN|0.18||0.367|TWO_SIDED|95.0|-0.52|0.19|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.19|-0.52|0.367
72383444|NCT00809354|144275218|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.2||0.995|TWO_SIDED|95.0|-0.39|0.39|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.39|-0.39|0.995
72558017|NCT03703258|144645487|SUPERIORITY||Slope|-0.12|STANDARD_ERROR_OF_MEAN|0.13||0.38|TWO_SIDED||||||Mixed Models Analysis||Condition x time interaction coefficient from mixed-effect model using negative binomial distribution. Intervention = 1 and control = 0.|||||.38
72558018|NCT03703258|144645487|SUPERIORITY||Cohen's D|-0.15|||||TWO_SIDED||||||||Between-group Cohen's d; calculated as within-group d(intervention) - within group d(control). Standardized using the standard deviation of the change scores. Negative values favor intervention and positive values favor control.|||||
72558019|NCT03703258|144645488|SUPERIORITY||Slope|-0.28|STANDARD_ERROR_OF_MEAN|0.14||0.04|TWO_SIDED||||||Mixed Models Analysis||Condition x time interaction coefficient from mixed-effect model using negative binomial distribution. Intervention = 1 and control = 0.|||||.04
72558020|NCT03703258|144645488|SUPERIORITY||Cohen's D|-0.7|||||TWO_SIDED||||||||Between-group Cohen's d; calculated as within-group d(intervention) - within group d(control). Standardized using the standard deviation of the change scores. Negative values favor intervention and positive values favor control.|||||
72558021|NCT03703258|144645489|SUPERIORITY||Slope|-1.23|STANDARD_ERROR_OF_MEAN|1.88||0.51|TWO_SIDED||||||Mixed Models Analysis||Post-intervention condition x time interaction coefficient from mixed-effect model using negative binomial distribution. Intervention = 1 and control = 0.|Baseline to post-intervention only||||.51
72558022|NCT03703258|144645489|SUPERIORITY||Slope|-0.9|STANDARD_ERROR_OF_MEAN|1.9||0.64|TWO_SIDED||||||Mixed Models Analysis||3 month condition x time interaction coefficient from mixed-effect model using negative binomial distribution. Intervention = 1 and control = 0.|Baseline to 3 months||||.64
72558023|NCT03703258|144645489|SUPERIORITY||Cohen's D|-0.1|||||TWO_SIDED||||||||Post-intervention between-group Cohen's d; calculated as within-group d(intervention) - within group d(control). Standardized using the standard deviation of the change scores. Negative values favor intervention and positive values favor control.|Baseline to post-intervention only||||
72383445|NCT00809354|144275218|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.07|STANDARD_ERROR_OF_MEAN|0.2||0.735|TWO_SIDED|95.0|-0.46|0.32|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.32|-0.46|0.735
72383446|NCT00809354|144275218|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.28|STANDARD_ERROR_OF_MEAN|0.2||0.169|TWO_SIDED|95.0|-0.67|0.12|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.12|-0.67|0.169
72383447|NCT00809354|144275218|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.21|STANDARD_ERROR_OF_MEAN|0.2||0.295|TWO_SIDED|95.0|-0.6|0.18|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.18|-0.60|0.295
72383448|NCT00809354|144275218|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.16||0.284|TWO_SIDED|95.0|-0.47|0.14|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.14|-0.47|0.284
72383449|NCT00809354|144275218|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.16||0.224|TWO_SIDED|95.0|-0.5|0.12|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.12|-0.50|0.224
72383450|NCT00809354|144275218|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.48|STANDARD_ERROR_OF_MEAN|0.16||0.002|TWO_SIDED|95.0|-0.79|-0.17|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.17|-0.79|0.002
72435276|NCT03068468|144383507|SUPERIORITY||Difference|-1.7||||0.4297|TWO_SIDED|95.0|-5.8|2.5|||MMRM|||Satisfaction With Your Life Today: Adjusted mean for each treatment group, difference with Placebo, 95% confidence interval and p-value at each time point were based on an MMRM model, with change from baseline in PSPQoL as dependent variable and with fixed effects of treatment group, time (categorical), treatment group-bytime interaction, baseline for PSP-QoL, baseline PSP-QoL by time interaction, baseline Color Trails 2 test (\<=170 or \>170 seconds) and region.||2.5|-5.8|0.4297
72435277|NCT03068468|144383508|SUPERIORITY||Difference|2.0||||0.2084|TWO_SIDED|95.0|-1.1|5.2|||MMRM|||Adjusted mean for each treatment group, difference with Placebo, 95% confidence interval and p-value at each time point were based on an MMRM model, with change from baseline in SEADL as dependent variable and with fixed effects of treatment group, time (categorical), treatment group-by-time interaction, baseline for SEADL , baseline SEADL by time interaction, baseline Color Trails 2 test (\<=170 or \>170 seconds) and region.||5.2|-1.1|0.2084
72435278|NCT03068468|144383509|SUPERIORITY||Difference|0.0||||0.5701|TWO_SIDED|95.0|-0.2|0.1|||MMRM|||Adjusted mean for each treatment group, difference with Placebo, 95% confidence interval and p-value at each time point were based on an MMRM model, with change from baseline in CGI-S as dependent variable and with fixed effects of treatment group, time (categorical), treatment group-by-time interaction, baseline for CGI-S, baseline CGI-S by time interaction, baseline Color Trails 2 test (\<=170 or \>170 seconds) and region.||0.1|-0.2|0.5701
72435279|NCT03068468|144383510|SUPERIORITY||Difference|0.9||||0.0517|TWO_SIDED|95.0|0.0|1.8|||MMRM|||Adjusted mean for each treatment group, difference with Placebo, 95% confidence interval and p-value at each time point were based on an MMRM model, with change from baseline in Phonemic Fluency Test as dependent variable and with fixed effects of treatment group, time (categorical), treatment group-by-time interaction, baseline Phonemic Fluency Test, baseline Phonemic Fluency Test by time interaction, baseline Color Trails 2 test (\<=170 or \>170 seconds) and region.||1.8|-0.0|0.0517
72435280|NCT03068468|144383511|SUPERIORITY||Difference|0.9||||0.0387|TWO_SIDED|95.0|0.0|1.7|||MMRM|||Adjusted mean for each treatment group, difference with Placebo, 95% confidence interval and p-value at each time point were based on an MMRM model, with change from baseline in Letter Number Sequence as dependent variable and with fixed effects of treatment group, time (categorical), treatment group-by-time interaction, baseline Letter Number Sequence, baseline Letter Number Sequence by time interaction, baseline Color Trails 2 test (\<=170 or \>170 seconds) and region.||1.7|0.0|0.0387
72435281|NCT03068468|144383512|SUPERIORITY||Difference|0.1||||0.9815|TWO_SIDED|95.0|-8.1|8.3|||MMRM|||Color Trails Test 1: Adjusted mean for each treatment group, difference with Placebo, 95% confidence interval and p-value at each time point were based on an MMRM model, with change from baseline in Color trails Test 1 as dependent variable and with fixed effects of treatment group, time (categorical), treatment group-by-time interaction, baseline for Color Trails Test 1, baseline Color Trails Test 1 by time interaction, baseline Color Trails 2 test (\<=170 or \>170 seconds) and region.||8.3|-8.1|0.9815
72558024|NCT03703258|144645489|SUPERIORITY||Cohen's D|0.02|||||TWO_SIDED||||||||3 month between-group Cohen's d; calculated as within-group d(intervention) - within group d(control). Standardized using the standard deviation of the change scores. Negative values favor intervention and positive values favor control.|Baseline to 3 months||||
72558025|NCT03703258|144645490|SUPERIORITY||Slope|0.64|STANDARD_ERROR_OF_MEAN|0.3||0.04|TWO_SIDED||||||Mixed Models Analysis||Post-intervention condition x time interaction coefficient from mixed-effect model using negative binomial distribution. Intervention = 1 and control = 0.|Baseline to post-intervention only||||.04
72383451|NCT00809354|144275218|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.16||0.355|TWO_SIDED|95.0|-0.45|0.16|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.16|-0.45|0.355
72618730|NCT01026038|144768109|SUPERIORITY_OR_OTHER||GMT ratio|1.1|||||TWO_SIDED|95.0|0.83|1.43||||||Serotype 18C: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||1.43|0.83|
72435282|NCT03068468|144383512|SUPERIORITY||Difference|0.0||||0.9869|TWO_SIDED|95.0|-5.7|5.6|||MMRM|||Color Trails Test 2: Adjusted mean for each treatment group, difference with Placebo, 95% confidence interval and p-value at each time point were based on an MMRM model, with change from baseline in Color Trails Test 2 as dependent variable and with fixed effects of treatment group, time (categorical), treatment group-by-time interaction, baseline for Color Trails Test 2, baseline Color Trails Test 2 by time interaction, and region.||5.6|-5.7|0.9869
72435283|NCT03068468|144383513|SUPERIORITY||Difference|0.5||||0.1763|TWO_SIDED|95.0|-0.2|1.2|||MMRM|||Adjusted mean for each treatment group, difference with Placebo, 95% confidence interval and p-value at each time point were based on an MMRM model, with change from baseline in MoCA as dependent variable and with fixed effects of treatment group, time (categorical), treatment group-by-time interaction, baseline for MoCA, baseline MoCA by time interaction,baseline Color Trails 2 test (\<=170 or \>170 seconds) and region.||1.2|-0.2|0.1763
72435284|NCT03068468|144383515|SUPERIORITY||Difference|-0.021||||0.9527|TWO_SIDED|95.0|-0.726|0.684|||MMRM|||Ventricles Volume: Adjusted mean for each treatment group, difference with Placebo, 95% confidence interval and p-value at each time point were based on an MMRM model, with change from baseline in MRI region as dependent variable and with fixed effects of treatment group, time (categorical), treatment group-by-time interaction, baseline for MRI region, baseline MRI region by time interaction, baseline Color Trails 2 test (\<=170 or \>170 seconds) and region.||0.684|-0.726|0.9527
72435285|NCT03068468|144383515|SUPERIORITY||Difference|-0.514||||0.7357|TWO_SIDED|95.0|-3.506|2.478|||MMRM|||Whole Brain Volume: Adjusted mean for each treatment group, difference with Placebo, 95% confidence interval and p-value at each time point were based on an MMRM model, with change from baseline in MRI region as dependent variable and with fixed effects of treatment group, time (categorical), treatment group-by-time interaction, baseline for MRI region, baseline MRI region by time interaction, baseline Color Trails 2 test (\<=170 or \>170 seconds) and region.||2.478|-3.506|0.7357
72435286|NCT03068468|144383515|SUPERIORITY||Difference|-0.004||||0.6439|TWO_SIDED|95.0|-0.023|0.014|||MMRM|||Midbrain Volume: Adjusted mean for each treatment group, difference with Placebo, 95% confidence interval and p-value at each time point were based on an MMRM model, with change from baseline in MRI region as dependent variable and with fixed effects of treatment group, time (categorical), treatment group-by-time interaction, baseline for MRI region, baseline MRI region by time interaction, baseline Color Trails 2 test (\<=170 or \>170 seconds) and region.||0.014|-0.023|0.6439
72435287|NCT03068468|144383515|SUPERIORITY||Difference|0.0||||0.9864|TWO_SIDED|95.0|-0.039|0.04|||MMRM|||Pons Volume: Adjusted mean for each treatment group, difference with Placebo, 95% confidence interval and p-value at each time point were based on an MMRM model, with change from baseline in MRI region as dependent variable and with fixed effects of treatment group, time (categorical), treatment group-by-time interaction, baseline for MRI region, baseline MRI region by time interaction, baseline Color Trails 2 test (\<=170 or \>170 seconds) and region.||0.040|-0.039|0.9864
72435288|NCT03068468|144383515|SUPERIORITY||Difference|0.001||||0.7529|TWO_SIDED|95.0|-0.004|0.006|||MMRM|||Cerebellar Peduncle Volume: Adjusted mean for each treatment group, difference with Placebo, 95% confidence interval and p-value at each time point were based on an MMRM model, with change from baseline in MRI region as dependent variable and with fixed effects of treatment group, time (categorical), treatment group-by-time interaction, baseline for MRI region, baseline MRI region by time interaction, baseline Color Trails 2 test (\<=170 or \>170 seconds) and region.||0.006|-0.004|0.7529
72435289|NCT03068468|144383515|SUPERIORITY||Difference|0.006||||0.685|TWO_SIDED|95.0|-0.025|0.038|||MMRM|||Third Ventricle Volume: Adjusted mean for each treatment group, difference with Placebo, 95% confidence interval and p-value at each time point were based on an MMRM model, with change from baseline in MRI region as dependent variable and with fixed effects of treatment group, time (categorical), treatment group-by-time interaction, baseline for MRI region, baseline MRI region by time interaction, baseline Color Trails 2 test (\<=170 or \>170 seconds) and region.||0.038|-0.025|0.6850
72435290|NCT03068468|144383515|SUPERIORITY||Difference|-0.041||||0.9|TWO_SIDED|95.0|-0.68|0.598|||MMRM|||Frontal Lobe Volume: Adjusted mean for each treatment group, difference with Placebo, 95% confidence interval and p-value at each time point were based on an MMRM model, with change from baseline in MRI region as dependent variable and with fixed effects of treatment group, time (categorical), treatment group-by-time interaction, baseline for MRI region, baseline MRI region by time interaction, baseline Color Trails 2 test (\<=170 or \>170 seconds) and region.||0.598|-0.680|0.9000
72435291|NCT01185522|144383558|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.74||||0.235|TWO_SIDED|95.0|0.45|1.22|||Univariate logistic regression model|||Comparison between genders: women and men.||1.22|0.45|0.235
72435292|NCT01185522|144383558|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.82||||0.331|TWO_SIDED|95.0|0.55|1.22|||Univariate logistic regression model|||Comparison between Age: \<= 55 years and \> 55 years||1.22|0.55|0.331
72435293|NCT01185522|144383558|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.49||||0.05|TWO_SIDED|95.0|1.0|2.23|||Univariate logistic regression model|||Comparison between time since initial diagnosis: \>= 10 years and \< 10 years||2.23|1.00|0.050
72558026|NCT03703258|144645490|SUPERIORITY||Slope|0.29|STANDARD_ERROR_OF_MEAN|0.3||0.34|TWO_SIDED||||||Mixed Models Analysis||3 month condition x time interaction coefficient from mixed-effect model using negative binomial distribution. Intervention = 1 and control = 0.|Baseline to 3 months||||.34
72435294|NCT01185522|144383558|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.47||||0.144|TWO_SIDED|95.0|0.88|2.46|||Univariate logistic regression model|||Comparison between participants without erosive rheumatoid arthritis (RA) and participants with erosive RA||2.46|0.88|0.144
72435295|NCT01185522|144383558|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.74||||0.01|TWO_SIDED|95.0|1.14|2.65|||Univariate logistic regression model|||Comparison between DAS-28 score: \<= 5.1 and DAS-28 \>5.1||2.65|1.14|0.010
72435296|NCT01185522|144383558|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.39||||0.119|TWO_SIDED|95.0|0.92|2.1|||Univariate logistic regression model|||Comparison between ESR: \<= 28 mm/h and \> 28 mm/h||2.10|0.92|0.119
72435297|NCT01185522|144383558|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.32||||0.265|TWO_SIDED|95.0|0.81|2.13|||Univariate logistic regression model|||Comparison between number of participants without anemia and number of participants with anemia||2.13|0.81|0.265
72435298|NCT01185522|144383558|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.14||||0.511|TWO_SIDED|95.0|0.77|1.71|||Univariate logistic regression model|||Comparison between dose of corticosteroids: \<= 5 mg and \> 5 mg||1.71|0.77|0.511
72558027|NCT03703258|144645490|SUPERIORITY||Cohen's D|0.92|||||TWO_SIDED||||||||Post-intervention between-group Cohen's d; calculated as within-group d(intervention) - within group d(control). Standardized using the standard deviation of the change scores. Positive values favor intervention and negative values favor control.|Baseline to post-intervention only||||
72383452|NCT00809354|144275218|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.23|STANDARD_ERROR_OF_MEAN|0.17||0.172|TWO_SIDED|95.0|-0.57|0.1|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.10|-0.57|0.172
72383453|NCT00809354|144275218|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.17||0.882|TWO_SIDED|95.0|-0.36|0.31|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.31|-0.36|0.882
72383454|NCT00809354|144275218|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.29|STANDARD_ERROR_OF_MEAN|0.17||0.084|TWO_SIDED|95.0|-0.63|0.04|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.04|-0.63|0.084
72383455|NCT00809354|144275218|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.17||0.405|TWO_SIDED|95.0|-0.47|0.19|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.19|-0.47|0.405
72383456|NCT00809354|144275218|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.62|STANDARD_ERROR_OF_MEAN|0.17|<|0.001|TWO_SIDED|95.0|-0.94|-0.3|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.30|-0.94|<0.001
72383457|NCT00809354|144275218|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.76|STANDARD_ERROR_OF_MEAN|0.17|<|0.001|TWO_SIDED|95.0|-1.09|-0.44|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.44|-1.09|<0.001
72383458|NCT00809354|144275218|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.97|STANDARD_ERROR_OF_MEAN|0.17|<|0.001|TWO_SIDED|95.0|-1.3|-0.64|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.64|-1.30|<0.001
72383459|NCT00809354|144275218|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.17|<|0.001|TWO_SIDED|95.0|-1.32|-0.67|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.67|-1.32|<0.001
72383460|NCT00809354|144275218|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.66|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|95.0|-1.02|-0.3|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.30|-1.02|<0.001
72383461|NCT00809354|144275218|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.63|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|95.0|-0.99|-0.27|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.27|-0.99|<0.001
72383462|NCT00809354|144275218|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.83|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|95.0|-1.19|-0.48|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.48|-1.19|<0.001
72383463|NCT00809354|144275218|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.93|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|95.0|-1.29|-0.57|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.57|-1.29|<0.001
72383464|NCT00809354|144275218|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.54|STANDARD_ERROR_OF_MEAN|0.18||0.002|TWO_SIDED|95.0|-0.89|-0.2|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.20|-0.89|0.002
72383465|NCT00809354|144275218|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.98|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|95.0|-1.32|-0.63|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.63|-1.32|<0.001
72383466|NCT00809354|144275218|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.04|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|95.0|-1.39|-0.7|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.70|-1.39|<0.001
72383467|NCT00809354|144275218|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|95.0|-1.55|-0.86|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.86|-1.55|<0.001
72383468|NCT00809354|144275218|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.19|<|0.001|TWO_SIDED|95.0|-1.18|-0.43|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.43|-1.18|<0.001
72383469|NCT00809354|144275218|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|0.19|<|0.001|TWO_SIDED|95.0|-1.28|-0.53|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.53|-1.28|<0.001
72435299|NCT01185522|144383558|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.34||||0.153|TWO_SIDED|95.0|0.9|2.0|||Univariate logistic regression model|||Comparison between HAQ score: \<= 1.5 and \> 1.5||2.00|0.90|0.153
72383470|NCT00809354|144275218|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.96|STANDARD_ERROR_OF_MEAN|0.19|<|0.001|TWO_SIDED|95.0|-1.33|-0.58|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.58|-1.33|<0.001
72383471|NCT00809354|144275218|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.18|STANDARD_ERROR_OF_MEAN|0.19|<|0.001|TWO_SIDED|95.0|-1.56|-0.81|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.81|-1.56|<0.001
72383472|NCT00809354|144275218|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.66|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|95.0|-1.02|-0.31|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.31|-1.02|<0.001
72435300|NCT01185522|144383558|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.19|||<|0.001|TWO_SIDED|95.0|1.45|3.31|||Univariate logistic regression model|||Comparison between VAS patient: fatigue \<= 66 and \> 66||3.31|1.45|<0.001
72383473|NCT00809354|144275218|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.72|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|95.0|-1.08|-0.37|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.37|-1.08|<0.001
72383474|NCT00809354|144275218|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|95.0|-1.36|-0.65|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.65|-1.36|<0.001
72383475|NCT00809354|144275218|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.17|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|95.0|-1.52|-0.81|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.81|-1.52|<0.001
72383476|NCT00809354|144275218|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|-1.29|-0.51|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.51|-1.29|<0.001
72383477|NCT00809354|144275218|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|-1.3|-0.51|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.51|-1.30|<0.001
72383478|NCT00809354|144275218|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.97|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|-1.36|-0.58|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.58|-1.36|<0.001
72383479|NCT00809354|144275218|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.18|STANDARD_ERROR_OF_MEAN|0.2|<|0.01|TWO_SIDED|95.0|-1.57|-0.79|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.79|-1.57|<0.01
72383480|NCT00809354|144275219|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.04|STANDARD_ERROR_OF_MEAN|0.06||0.469|TWO_SIDED|95.0|-0.08|0.17|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.17|-0.08|0.469
72383481|NCT00809354|144275219|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.05|STANDARD_ERROR_OF_MEAN|0.06||0.387|TWO_SIDED|95.0|-0.18|0.07|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.07|-0.18|0.387
72383482|NCT00809354|144275219|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.01|STANDARD_ERROR_OF_MEAN|0.06||0.887|TWO_SIDED|95.0|-0.11|0.13|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.13|-0.11|0.887
72383483|NCT00809354|144275219|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.11|STANDARD_ERROR_OF_MEAN|0.06||0.084|TWO_SIDED|95.0|-0.01|0.23|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.23|-0.01|0.084
72383484|NCT00809354|144275219|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.16|STANDARD_ERROR_OF_MEAN|0.07||0.018|TWO_SIDED|95.0|0.03|0.29|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.29|0.03|0.018
72383485|NCT00809354|144275219|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.02|STANDARD_ERROR_OF_MEAN|0.07||0.783|TWO_SIDED|95.0|-0.11|0.15|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.15|-0.11|0.783
72383486|NCT00809354|144275219|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.02|STANDARD_ERROR_OF_MEAN|0.07||0.762|TWO_SIDED|95.0|-0.11|0.15|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.15|-0.11|0.762
72383487|NCT00809354|144275219|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.16|STANDARD_ERROR_OF_MEAN|0.07||0.017|TWO_SIDED|95.0|0.03|0.29|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.29|0.03|0.017
72383488|NCT00809354|144275219|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.08|STANDARD_ERROR_OF_MEAN|0.06||0.207|TWO_SIDED|95.0|-0.2|0.04|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.04|-0.20|0.207
72435301|NCT01185522|144383558|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.04|||<|0.001|TWO_SIDED|95.0|1.35|3.08|||Univariate logistic regression model|||Comparison between VAS patient: pain \<= 66 and \> 66||3.08|1.35|<0.001
72435302|NCT01185522|144383558|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.54||||0.261|TWO_SIDED|95.0|0.86|2.75|||Univariate logistic regression model|||Comparison between VAS patient (quality of sleep) score: \<=30 score and 30 - 59 score||2.75|0.86|0.261
72435303|NCT01185522|144383558|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.17||||0.261|TWO_SIDED|95.0|0.67|2.05|||Univariate logistic regression model|||Comparison between VAS patient (quality of sleep) score: \<= 30 and 59 - 77||2.05|0.67|0.261
72435304|NCT01185522|144383558|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.66||||0.261|TWO_SIDED|95.0|0.95|2.89|||Univariate logistic regression model|||Comparison between VAS patient (quality of sleep) score: \<= 30 and \> 77||2.89|0.95|0.261
72383489|NCT00809354|144275219|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.15|STANDARD_ERROR_OF_MEAN|0.06||0.02|TWO_SIDED|95.0|-0.27|-0.02|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.02|-0.27|0.020
72383490|NCT00809354|144275219|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.06||0.941|TWO_SIDED|95.0|-0.13|0.12|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.12|-0.13|0.941
72383491|NCT00809354|144275219|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.05|STANDARD_ERROR_OF_MEAN|0.07||0.494|TWO_SIDED|95.0|-0.18|0.09|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.09|-0.18|0.494
72435305|NCT01185522|144383558|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.08|||<|0.001|TWO_SIDED|95.0|1.38|3.14|||Univariate logistic regression model|||Comparison between VAS patient: global assessment score: \<= 67 and \> 67||3.14|1.38|<0.001
72435306|NCT01185522|144383558|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.28|||<|0.001|TWO_SIDED|95.0|1.5|3.47|||Univariate logistic regression model|||Comparison between SF36 vitality score: \> 33 and \<= 33||3.47|1.50|< 0.001
72435307|NCT01185522|144383558|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.08||||0.399|TWO_SIDED|95.0|0.6|1.93|||Univariate logistic regression model|||Comparison between HADS score: Anxiety (No case) and HADS score: Anxiety (Doubtful case)||1.93|0.60|0.399
72558028|NCT03703258|144645490|SUPERIORITY||Cohen's D|0.68|||||TWO_SIDED||||||||3 month between-group Cohen's d; calculated as within-group d(intervention) - within group d(control). Standardized using the standard deviation of the change scores. Positive values favor intervention and negative values favor control.|Baseline to 3 months||||
72558029|NCT03703258|144645491|SUPERIORITY||Slope|-2.46|STANDARD_ERROR_OF_MEAN|1.63||0.13|TWO_SIDED||||||Mixed Models Analysis||Post-intervention condition x time interaction coefficient from mixed-effect model using negative binomial distribution. Intervention = 1 and control = 0.|Baseline to post-intervention only||||.13
72558030|NCT03703258|144645491|SUPERIORITY||Slope|-1.94|STANDARD_ERROR_OF_MEAN|1.64||0.24|TWO_SIDED||||||Mixed Models Analysis||3 month condition x time interaction coefficient from mixed-effect model using negative binomial distribution. Intervention = 1 and control = 0.|Baseline to 3 months||||.24
72435308|NCT01185522|144383558|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.78||||0.399|TWO_SIDED|95.0|0.48|1.26|||Univariate logistic regression model|||Comparison between HADS score: Anxiety (No case) and HADS score: Anxiety (Certain case)||1.26|0.48|0.399
72435309|NCT01185522|144383558|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.09||||0.858|TWO_SIDED|95.0|0.65|1.81|||Univariate logistic regression model|||Comparison between HADS score: Depression (No Case) and HADS score: Depression (Doubtful case)||1.81|0.65|0.858
72435310|NCT01185522|144383558|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.93||||0.858|TWO_SIDED|95.0|0.57|1.52|||Univariate logistic regression model|||Comparison between HADS score: Depression (No Case) and HADS score: Depression (Certain case)||1.52|0.57|0.858
72435311|NCT01185522|144383558|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.63||||0.036|TWO_SIDED|95.0|1.03|2.58|||Multivariate logistic regression model|||Comparison between time since initial diagnosis: \>= 10 years and \< 10 years||2.58|1.03|0.036
72435312|NCT01185522|144383559|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.16||||0.004|TWO_SIDED|95.0|1.05|1.28|||Univariate logistic regression model|||Predictive factor: C-Reactive Protein||1.28|1.05|0.004
72435313|NCT01185522|144383559|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.14||||0.013|TWO_SIDED|95.0|1.03|1.27|||Multivariate logistic regression model|||Predictive factor: C-Reactive Protein||1.27|1.03|0.013
72435314|NCT01185522|144383560|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.02||||0.253|TWO_SIDED|95.0|0.99|1.05|||Univariate logistic regression model|||Predictive factor: Tender joint||1.05|0.99|0.253
72435315|NCT01185522|144383560|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.05||||0.021|TWO_SIDED|95.0|1.01|1.09|||Univariate logistic regression model|||Predictive factor : Swollen joint||1.09|1.01|0.021
72435316|NCT01803646|144383620|SUPERIORITY||Mean Difference (Net)|-0.17||||0.32|TWO_SIDED|95.0|-0.51|0.17|||Mixed Models Analysis|||||0.17|-0.51|0.32
72435317|NCT01803646|144383621|SUPERIORITY||Mean Difference (Net)|-0.79||||0.63|TWO_SIDED|95.0|-4.0|2.4|||Mixed Models Analysis|||||2.4|-4|0.63
72435318|NCT01803646|144383622|SUPERIORITY|||||||0.821|||||||Fisher Exact|||Analysis for air conduction||||0.821
72435319|NCT01803646|144383622|SUPERIORITY|||||||1|||||||Fisher Exact|||Analysis for bone conduction||||1.0
72435320|NCT01368406|144383625|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.48||||0.055|TWO_SIDED|95.0|-0.65|1.13|||t-test, 2 sided|t test for independent samples||||1.13|-0.65|0.055
72435321|NCT01368406|144383625|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.48||||0.055|TWO_SIDED|95.0|0.13|0.83|||t-test, 2 sided|||||0.83|0.13|0.055
72435322|NCT02228408|144383629|SUPERIORITY|||||||0.04|||||||poisson|||||||0.04
72435323|NCT02228408|144383630|SUPERIORITY|||||||0.19|||||||t-test, 2 sided|||||||0.19
72435324|NCT02228408|144383631|SUPERIORITY|||||||0.34|||||||t-test, 2 sided|||||||0.34
72435325|NCT02228408|144383635|SUPERIORITY|||||||0.62|||||||t-test, 2 sided|||||||0.62
72435326|NCT03670602|144383651|SUPERIORITY|||||||0.0035||||||This is for the treatment group x time effect, or if treatment influenced improvements in delay discounting across all three timepoints. The threshold for statistical significance was p = 0.05|Mixed Models Analysis|Analyses were Intention to Treat (ITT) and included all randomized participants||A mixed model ANCOVA with unstructured covariance and random effects of participant. Treatment group and cohort were the between subject variables, weeks as the repeated measure and site as a covariate.||||0.0035
72435327|NCT03670602|144383651|SUPERIORITY||||||<|0.001||||||This is for the time effect, or if delay discounting improved across all three timepoints, independent of treatment group. The threshold for statistical significance was p = 0.05|Mixed Models Analysis|Analyses were Intention to Treat (ITT) and included all randomized participants||A mixed model ANCOVA with unstructured covariance and random effects of participant. Treatment group and cohort were the between subject variables, weeks as the repeated measure and site as a covariate||||<0.001
72435328|NCT03670602|144383652|SUPERIORITY|||||||0.85||||||This is for the treatment group x time effect, or if treatment differentially influenced weight across all three timepoints. The threshold for statistical significance was p = 0.05|Mixed Models Analysis|Analyses were Intention to Treat (ITT) and included all randomized participants||A mixed model ANCOVA with unstructured covariance and random effects of participant. Group and cohort were the between subject variables, weeks as the repeated measure and site as a covariate||||0.85
72435329|NCT03670602|144383652|SUPERIORITY||||||<|0.001||||||This is for the time effect, or if time influenced changes in weight, independent of treatment group. The threshold for statistical significance was p = 0.05|Mixed Models Analysis|Analyses were Intention to Treat (ITT) and included all randomized participants||A mixed model ANCOVA with unstructured covariance and random effects of participant. Group and cohort were the between subject variables, weeks as the repeated measure and site as a covariate||||<0.001
72435330|NCT03670602|144383653|SUPERIORITY|||||||0.79||||||This is for the treatment group x time effect, or if treatment group influenced change in hBa1c across all three timepoints. The threshold for statistical significance was p = 0.05|Mixed Models Analysis|Analyses were Intention to Treat (ITT) and included all randomized participants||A mixed model ANCOVA with unstructured covariance and random effects of participant. Group and cohort were the between subject variables, weeks as the repeated measure and site as a covariate||||0.79
72558031|NCT03703258|144645491|SUPERIORITY||Cohen's D|-0.41|||||TWO_SIDED||||||||Post-intervention between-group Cohen's d; calculated as within-group d(intervention) - within group d(control). Standardized using the standard deviation of the change scores. Negative values favor intervention and positive values favor control.|Baseline to post-intervention only||||
72494260|NCT01077973|144517414|SUPERIORITY_OR_OTHER||LS mean difference|-0.42||||0.281|TWO_SIDED|95.0|-1.17|0.34||p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPID 0-3: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.34|-1.17|0.281
72494261|NCT01077973|144517414|SUPERIORITY_OR_OTHER||LS mean difference|-0.21||||0.582|TWO_SIDED|95.0|-0.97|0.55||p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPID 0-3: Treatment difference \[Ibuprofen (Motrin IB) - placebo\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.55|-0.97|0.582
72494262|NCT01077973|144517414|SUPERIORITY_OR_OTHER||LS mean difference|-0.2||||0.523|TWO_SIDED|95.0|-0.83|0.42||p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPID 0-3: Treatment difference \[Ibuprofen sodium - Ibuprofen (Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.42|-0.83|0.523
72494263|NCT01077973|144517415|SUPERIORITY_OR_OTHER||LS mean difference|-0.45||||0.327|TWO_SIDED|95.0|-1.35|0.45||p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||TOTPAR 0-2: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.45|-1.35|0.327
72494264|NCT01077973|144517415|SUPERIORITY_OR_OTHER||LS mean difference|-0.32||||0.489|TWO_SIDED|95.0|-1.21|0.58||p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||TOTPAR 0-2: Treatment difference \[Ibuprofen (Motrin IB) - placebo\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.58|-1.21|0.489
72494265|NCT01077973|144517415|SUPERIORITY_OR_OTHER||LS mean difference|-0.13||||0.726|TWO_SIDED|95.0|-0.88|0.61||p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||TOTPAR 0-2: Treatment difference \[Ibuprofen sodium - Ibuprofen (Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.61|-0.88|0.726
72494266|NCT01077973|144517415|SUPERIORITY_OR_OTHER||LS mean difference|-0.7||||0.32|TWO_SIDED|95.0|-2.09|0.69||p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||TOTPAR 0-3: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.69|-2.09|0.320
72494267|NCT01077973|144517415|SUPERIORITY_OR_OTHER||LS mean difference|-0.47||||0.506|TWO_SIDED|95.0|-1.86|0.92||p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||TOTPAR 0-3: Treatment difference \[Ibuprofen (Motrin IB) - placebo\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.92|-1.86|0.506
72494268|NCT01077973|144517415|SUPERIORITY_OR_OTHER||LS mean difference|-0.23||||0.691|TWO_SIDED|95.0|-1.38|0.92||p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||TOTPAR 0-3: Treatment difference \[Ibuprofen sodium - Ibuprofen (Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.92|-1.38|0.691
72494269|NCT01077973|144517416|SUPERIORITY_OR_OTHER||LS mean difference|-0.72||||0.292|TWO_SIDED|95.0|-2.07|0.62||p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPRID 0-2: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.62|-2.07|0.292
72494270|NCT01077973|144517416|SUPERIORITY_OR_OTHER||LS mean difference|-0.53||||0.439|TWO_SIDED|95.0|-1.87|0.82||p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPRID 0-2: Treatment difference \[Ibuprofen (Motrin IB) - placebo\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.82|-1.87|0.439
72494271|NCT01077973|144517416|SUPERIORITY_OR_OTHER||LS mean difference|-0.19||||0.733|TWO_SIDED|95.0|-1.31|0.92||p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPRID 0-2: Treatment difference \[Ibuprofen sodium - Ibuprofen (Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.92|-1.31|0.733
72494272|NCT01077973|144517416|SUPERIORITY_OR_OTHER||LS mean difference|-0.68||||0.526|TWO_SIDED|95.0|-2.8|1.43||p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPRID 0-3: Treatment difference \[Ibuprofen (Motrin IB) - placebo\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.43|-2.80|0.526
72494273|NCT01077973|144517416|SUPERIORITY_OR_OTHER||LS mean difference|-0.44||||0.624|TWO_SIDED|95.0|-2.19|1.31||p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPRID 0-3: Treatment difference \[Ibuprofen sodium - Ibuprofen (Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.31|-2.19|0.624
72494274|NCT01077973|144517417|SUPERIORITY_OR_OTHER||Difference in proportion|3.02||||0.672|TWO_SIDED|95.0|-11.03|17.07||p-value was calculated using CMH test which was adjusted for baseline PSR, and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||0.5 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on Cochran-Mantel-Haenszel (CMH) adjusted proportions and the corresponding standard error.||17.07|-11.03|0.672
72383492|NCT00809354|144275219|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.11|STANDARD_ERROR_OF_MEAN|0.07||0.089|TWO_SIDED|95.0|-0.25|0.02|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.02|-0.25|0.089
72383493|NCT00809354|144275219|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.05|STANDARD_ERROR_OF_MEAN|0.07||0.467|TWO_SIDED|95.0|-0.18|0.08|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.08|-0.18|0.467
72383494|NCT00809354|144275219|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.02|STANDARD_ERROR_OF_MEAN|0.07||0.774|TWO_SIDED|95.0|-0.11|0.15|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.15|-0.11|0.774
72383495|NCT00809354|144275219|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.06|STANDARD_ERROR_OF_MEAN|0.06||0.315|TWO_SIDED|95.0|-0.06|0.19|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.19|-0.06|0.315
72383496|NCT00809354|144275219|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.11|STANDARD_ERROR_OF_MEAN|0.07||0.088|TWO_SIDED|95.0|-0.25|0.02|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.02|-0.25|0.088
72435331|NCT03670602|144383653|SUPERIORITY||||||<|0.001||||||This is for the time effect, or if hBa1c changed across timepoints, independent of treatment group. The threshold for statistical significance was p = 0.05|Mixed Models Analysis|Analyses were Intention to Treat (ITT) and included all randomized participants||A mixed model ANCOVA with unstructured covariance and random effects of participant. Group and cohort were the between subject variables, weeks as the repeated measure and site as a covariate||||<0.001
72435332|NCT03670602|144383654|SUPERIORITY|||||||0.201||||||This is for the treatment group x time effect, or if treatment differentially influenced medication adherence across all three timepoints. The threshold for statistical significance was p = 0.05|Mixed Models Analysis|Analyses were Intention to Treat (ITT) and included all randomized participants||A mixed model ANCOVA with unstructured covariance and random effects of participant. Group and cohort were the between subject variables, weeks as the repeated measure and site as a covariate||||0.201
72435333|NCT03670602|144383654|SUPERIORITY|||||||0.315||||||This is for the time effect, or if timepoint influenced medication adherence across all timepoints, independent of treatment group. The threshold for statistical significance was p = 0.05.|Mixed Models Analysis|Analyses were Intention to Treat (ITT) and included all randomized participants||A mixed model ANCOVA with unstructured covariance and random effects of participant. Group and cohort were the between subject variables, weeks as the repeated measure and site as a covariate||||0.315
72435334|NCT03670602|144383655|SUPERIORITY|A mixed model ANCOVA with unstructured covariance and random effects of participant. Group and cohort were the between subject variables, weeks as the repeated measure and site as a covariate||||||0.345||||||This is for the treatment group x time effect, or if treatment group influenced change in percent of time engaged in moderate-to-vigorous physical activity (MVPA) across all three timepoints. The threshold for statistical significance was p = 0.05|Mixed Models Analysis|Analyses were Intention to Treat (ITT) and included all randomized participants||||||0.345
72435335|NCT03670602|144383655|SUPERIORITY|||||||0.0003||||||This is for the time effect, or if percent of time engaged in moderate-to-vigorous physical activity (MVPA) changed across timepoints, independent of treatment group. The threshold for statistical significance was p = 0.05|Mixed Models Analysis|Analyses were Intention to Treat (ITT) and included all randomized participants||A mixed model ANCOVA with unstructured covariance and random effects of participant. Group and cohort were the between subject variables, weeks as the repeated measure and site as a covariate||||0.0003
72435336|NCT03670602|144383656|SUPERIORITY|||||||0.007||||||This is for the treatment group x time effect, or if treatment differentially influenced changes in calorie intake across all three timepoints. The threshold for statistical significance was p = 0.05|Mixed Models Analysis|||A mixed model ANCOVA with unstructured covariance and random effects of participant. Group and cohort were the between subject variables, weeks as the repeated measure and site as a covariate||||0.007
72435337|NCT03670602|144383656|SUPERIORITY||||||<|0.0001||||||This is for the time effect, or if time influenced changes in calorie intake, independent of treatment group. The threshold for statistical significance was p = 0.05|Mixed Models Analysis|||A mixed model ANCOVA with unstructured covariance and random effects of participant. Group and cohort were the between subject variables, weeks as the repeated measure and site as a covariate||||<0.0001
72435338|NCT03670602|144383657|SUPERIORITY|||||||0.774||||||This is for the treatment group x time effect, or if treatment differentially influenced changes in working memory across all three timepoints. The threshold for statistical significance was p = 0.05|Mixed Models Analysis|Analyses were Intention to Treat (ITT) and included all randomized participants||A mixed model ANCOVA with unstructured covariance and random effects of participant. Group and cohort were the between subject variables, weeks as the repeated measure and site as a covariate||||0.774
72435339|NCT03670602|144383657|SUPERIORITY|||||||0.019||||||This is for the time effect, or if time influenced changes in working memory, independent of treatment group. The threshold for statistical significance was p = 0.05|Mixed Models Analysis|Analyses were Intention to Treat (ITT) and included all randomized participants||A mixed model ANCOVA with unstructured covariance and random effects of participant. Group and cohort were the between subject variables, weeks as the repeated measure and site as a covariate||||0.019
72494275|NCT01077973|144517417|SUPERIORITY_OR_OTHER||Difference in proportion|-4.47||||0.467|TWO_SIDED|95.0|-17.61|8.68||p-value was calculated using CMH test which was adjusted for baseline PSR, and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||0.5 hours: Treatment difference \[Ibuprofen (Motrin IB) - placebo\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||8.68|-17.61|0.467
72383497|NCT00809354|144275219|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.12|STANDARD_ERROR_OF_MEAN|0.07||0.084|TWO_SIDED|95.0|-0.25|0.02|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.02|-0.25|0.084
72383498|NCT00809354|144275219|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.12|STANDARD_ERROR_OF_MEAN|0.07||0.066|TWO_SIDED|95.0|-0.25|0.01|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.01|-0.25|0.066
72383499|NCT00809354|144275219|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.12|STANDARD_ERROR_OF_MEAN|0.07||0.073|TWO_SIDED|95.0|-0.25|0.01|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.01|-0.25|0.073
72494276|NCT01077973|144517417|SUPERIORITY_OR_OTHER||Difference in proportion|7.55||||0.164|TWO_SIDED|95.0|-2.96|18.05||p-value was calculated using CMH test which was adjusted for baseline PSR, and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||0.5 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||18.05|-2.96|0.164
72383500|NCT00809354|144275219|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.03|STANDARD_ERROR_OF_MEAN|0.07||0.682|TWO_SIDED|95.0|-0.16|0.1|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.10|-0.16|0.682
72383501|NCT00809354|144275219|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.17|STANDARD_ERROR_OF_MEAN|0.07||0.014|TWO_SIDED|95.0|-0.3|-0.03|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.03|-0.30|0.014
72383502|NCT00809354|144275219|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.15|STANDARD_ERROR_OF_MEAN|0.07||0.027|TWO_SIDED|95.0|-0.28|-0.02|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.02|-0.28|0.027
72383503|NCT00809354|144275219|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.01|STANDARD_ERROR_OF_MEAN|0.07||0.871|TWO_SIDED|95.0|-0.14|0.12|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.12|-0.14|0.871
72383504|NCT00809354|144275219|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.07|STANDARD_ERROR_OF_MEAN|0.07||0.301|TWO_SIDED|95.0|-0.21|0.06|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.06|-0.21|0.301
72383505|NCT00809354|144275219|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.09|STANDARD_ERROR_OF_MEAN|0.07||0.181|TWO_SIDED|95.0|-0.23|0.04|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.04|-0.23|0.181
72383506|NCT00809354|144275219|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.17|STANDARD_ERROR_OF_MEAN|0.07||0.013|TWO_SIDED|95.0|-0.3|-0.04|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.04|-0.30|0.013
72383507|NCT00809354|144275219|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.15|STANDARD_ERROR_OF_MEAN|0.07||0.031|TWO_SIDED|95.0|-0.28|-0.01|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.01|-0.28|0.031
72383508|NCT00809354|144275219|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.01|STANDARD_ERROR_OF_MEAN|0.07||0.874|TWO_SIDED|95.0|-0.15|0.13|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.13|-0.15|0.874
72383509|NCT00809354|144275219|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.05|STANDARD_ERROR_OF_MEAN|0.07||0.447|TWO_SIDED|95.0|-0.19|0.08|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.08|-0.19|0.447
72383510|NCT00809354|144275219|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.13|STANDARD_ERROR_OF_MEAN|0.07||0.059|TWO_SIDED|95.0|-0.27|0.01|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.01|-0.27|0.059
72383511|NCT00809354|144275219|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.09|STANDARD_ERROR_OF_MEAN|0.07||0.196|TWO_SIDED|95.0|-0.23|0.05|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.05|-0.23|0.196
72383512|NCT00809354|144275219|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.06|STANDARD_ERROR_OF_MEAN|0.06||0.36|TWO_SIDED|95.0|-0.18|0.06|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.06|-0.18|0.360
72383513|NCT00809354|144275219|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.01|STANDARD_ERROR_OF_MEAN|0.06||0.845|TWO_SIDED|95.0|-0.13|0.11|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.11|-0.13|0.845
72383514|NCT00809354|144275219|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.11|STANDARD_ERROR_OF_MEAN|0.06||0.076|TWO_SIDED|95.0|-0.23|0.01|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.01|-0.23|0.076
72383515|NCT00809354|144275219|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.06||0.957|TWO_SIDED|95.0|-0.12|0.12|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.12|-0.12|0.957
72383516|NCT00809354|144275219|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.06|STANDARD_ERROR_OF_MEAN|0.07||0.404|TWO_SIDED|95.0|-0.19|0.08|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.08|-0.19|0.404
72383517|NCT00809354|144275219|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.1|STANDARD_ERROR_OF_MEAN|0.07||0.128|TWO_SIDED|95.0|-0.03|0.23|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.23|-0.03|0.128
72558032|NCT03703258|144645491|SUPERIORITY||Cohen's D|-0.23|||||TWO_SIDED||||||||3 month between-group Cohen's d; calculated as within-group d(intervention) - within group d(control). Standardized using the standard deviation of the change scores. Negative values favor intervention and positive values favor control.|Baseline to 3 months||||
72383518|NCT00809354|144275219|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.04|STANDARD_ERROR_OF_MEAN|0.07||0.577|TWO_SIDED|95.0|-0.17|0.09|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.09|-0.17|0.577
72383519|NCT00809354|144275219|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.12|STANDARD_ERROR_OF_MEAN|0.07||0.068|TWO_SIDED|95.0|-0.01|0.25|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.25|-0.01|0.068
72383520|NCT00809354|144275219|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.16|STANDARD_ERROR_OF_MEAN|0.06||0.011|TWO_SIDED|95.0|-0.28|-0.04|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.04|-0.28|0.011
72383521|NCT00809354|144275219|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.24|STANDARD_ERROR_OF_MEAN|0.06|<|0.001|TWO_SIDED|95.0|-0.36|-0.11|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.11|-0.36|<0.001
72383522|NCT00809354|144275219|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.06|<|0.001|TWO_SIDED|95.0|-0.43|-0.18|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.18|-0.43|<0.001
72383523|NCT00809354|144275219|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.24|STANDARD_ERROR_OF_MEAN|0.06|<|0.001|TWO_SIDED|95.0|-0.36|-0.12|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.12|-0.36|<0.001
72383524|NCT00809354|144275219|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.14|STANDARD_ERROR_OF_MEAN|0.07||0.043|TWO_SIDED|95.0|-0.27|0.0|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.00|-0.27|0.043
72494277|NCT01077973|144517417|SUPERIORITY_OR_OTHER||Difference in proportion|-7.52||||0.427|TWO_SIDED|95.0|-25.96|10.92||p-value was calculated using CMH test which was adjusted for baseline PSR, and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1 hour: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||10.92|-25.96|0.427
72494278|NCT01077973|144517417|SUPERIORITY_OR_OTHER||Difference in proportion|-5.66||||0.537|TWO_SIDED|95.0|-23.57|12.25||p-value was calculated using CMH test which was adjusted for baseline PSR, and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1 hour: Treatment difference \[Ibuprofen (Motrin IB) - placebo\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||12.25|-23.57|0.537
72494279|NCT01077973|144517417|SUPERIORITY_OR_OTHER||Difference in proportion|-1.83||||0.813|TWO_SIDED|95.0|-16.88|13.22||p-value was calculated using CMH test which was adjusted for baseline PSR, and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1 hour: Treatment difference \[Ibuprofen sodium - Ibuprofen (Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||13.22|-16.88|0.813
72494280|NCT01077973|144517417|SUPERIORITY_OR_OTHER||Difference in proportion|-5.5||||0.455|TWO_SIDED|95.0|-19.24|8.24||p-value was calculated using CMH test which was adjusted for baseline PSR, and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||2 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||8.24|-19.24|0.455
72494281|NCT01077973|144517417|SUPERIORITY_OR_OTHER||Difference in proportion|-4.02||||0.57|TWO_SIDED|95.0|-17.63|9.59||p-value was calculated using CMH test which was adjusted for baseline PSR, and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||2 hours: Treatment difference \[Ibuprofen (Motrin IB) - placebo\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||9.59|-17.63|0.570
72494282|NCT01077973|144517417|SUPERIORITY_OR_OTHER||Difference in proportion|-1.65||||0.792|TWO_SIDED|95.0|-13.8|10.5||p-value was calculated using CMH test which was adjusted which was adjusted for baseline PSR, and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||2 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||10.50|-13.80|0.792
72494283|NCT01077973|144517417|SUPERIORITY_OR_OTHER||Difference in proportion|-4.25||||0.556|TWO_SIDED|95.0|-17.82|9.33||p-value was calculated using CMH test which was adjusted for baseline PSR, and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||3 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||9.33|-17.82|0.556
72494284|NCT01077973|144517417|SUPERIORITY_OR_OTHER||Difference in proportion|-2.77||||0.689|TWO_SIDED|95.0|-16.24|10.69||p-value was calculated using CMH test which was adjusted for baseline PSR, and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||3 hours: Treatment difference \[Ibuprofen (Motrin IB) - placebo\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||10.69|-16.24|0.689
72494285|NCT01077973|144517417|SUPERIORITY_OR_OTHER||Difference in proportion|-1.65||||0.786|TWO_SIDED|95.0|-13.45|10.14||p-value was calculated using CMH test which was adjusted for baseline PSR, and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||3 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||10.14|-13.45|0.786
72494286|NCT01077973|144517418|SUPERIORITY_OR_OTHER||Difference in proportion|6.06||||0.48|TWO_SIDED|95.0|-10.86|22.99||p-value was calculated using CMH test which was adjusted for baseline PSR, and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||0.5 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||22.99|-10.86|0.480
72494287|NCT01077973|144517418|SUPERIORITY_OR_OTHER||Difference in proportion|4.34||||0.612|TWO_SIDED|95.0|-12.55|21.23||p-value was calculated using CMH test which was adjusted for baseline PSR, and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||0.5 hours: Treatment difference \[Ibuprofen (Motrin IB) - placebo\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||21.23|-12.55|0.612
72383525|NCT00809354|144275219|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.07||0.007|TWO_SIDED|95.0|-0.31|-0.05|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.05|-0.31|0.007
72383526|NCT00809354|144275219|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.25|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|95.0|-0.38|-0.12|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.12|-0.38|<0.001
72494288|NCT01077973|144517418|SUPERIORITY_OR_OTHER||Difference in proportion|1.47||||0.839|TWO_SIDED|95.0|-12.6|15.55||p-value was calculated using CMH test which was adjusted for baseline PSR, and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||0.5 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||15.55|-12.60|0.839
72494289|NCT01077973|144517418|SUPERIORITY_OR_OTHER||Difference in proportion|-13.2||||0.13|TWO_SIDED|95.0|-29.4|2.99||p-value was calculated using CMH test which was adjusted for baseline PSR, and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1 hour: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||2.99|-29.40|0.130
72494290|NCT01077973|144517418|SUPERIORITY_OR_OTHER||Difference in proportion|-7.83||||0.331|TWO_SIDED|95.0|-23.39|7.73||p-value was calculated using CMH test which was adjusted for baseline PSR, and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1 hour: Treatment difference \[Ibuprofen (Motrin IB) - placebo\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||7.73|-23.39|0.331
72494291|NCT01077973|144517418|SUPERIORITY_OR_OTHER||Difference in proportion|-5.5||||0.45|TWO_SIDED|95.0|-19.59|8.59||p-value was calculated using CMH test which was adjusted for baseline PSR, and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1 hour: Treatment difference \[Ibuprofen sodium - Ibuprofen (Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||8.59|-19.59|0.450
72494292|NCT01077973|144517418|SUPERIORITY_OR_OTHER||Difference in proportion|-4.25||||0.556|TWO_SIDED|95.0|-17.82|9.33||p-value was calculated using CMH test which was adjusted for baseline PSR, and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||2 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||9.33|-17.82|0.556
72494293|NCT01077973|144517418|SUPERIORITY_OR_OTHER||Difference in proportion|-2.77||||0.689|TWO_SIDED|95.0|-16.24|10.69||p-value was calculated using CMH test which was adjusted for baseline PSR, and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||2 hours: Treatment difference \[Ibuprofen (Motrin IB) - placebo\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||10.69|-16.24|0.689
72558033|NCT03703258|144645492|SUPERIORITY||Slope|-0.05|STANDARD_ERROR_OF_MEAN|0.25||0.85|TWO_SIDED||||||Mixed Models Analysis||Post-intervention condition x time interaction coefficient from mixed-effect model using negative binomial distribution. Intervention = 1 and control = 0.|Baseline to post-intervention only||||.85
72383527|NCT00809354|144275219|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.23|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|95.0|-0.36|-0.1|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.10|-0.36|<0.001
72383528|NCT00809354|144275219|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.07||0.074|TWO_SIDED|95.0|-0.25|0.01|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.01|-0.25|0.074
72383529|NCT00809354|144275219|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.23|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|95.0|-0.37|-0.1|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.10|-0.37|<0.001
72383530|NCT00809354|144275219|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.24|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|95.0|-0.37|-0.1|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.10|-0.37|<0.001
72383531|NCT00809354|144275219|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.36|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|95.0|-0.49|-0.23|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.23|-0.49|<0.001
72383532|NCT00809354|144275219|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.07||0.236|TWO_SIDED|95.0|-0.21|0.05|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.05|-0.21|0.236
72383533|NCT00809354|144275219|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.07||0.112|TWO_SIDED|95.0|-0.24|0.02|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.02|-0.24|0.112
72383534|NCT00809354|144275219|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.24|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|95.0|-0.38|-0.11|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.11|-0.38|<0.001
72383535|NCT00809354|144275219|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.26|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|95.0|-0.39|-0.12|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.12|-0.39|<0.001
72383536|NCT00809354|144275219|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.07||0.059|TWO_SIDED|95.0|-0.26|0.01|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.01|-0.26|0.059
72383537|NCT00809354|144275219|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.07||0.003|TWO_SIDED|95.0|-0.33|-0.07|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.07|-0.33|0.003
72558034|NCT03703258|144645492|SUPERIORITY||Slope|0.01|STANDARD_ERROR_OF_MEAN|0.25||0.96|TWO_SIDED||||||Mixed Models Analysis||3 month condition x time interaction coefficient from mixed-effect model using negative binomial distribution. Intervention = 1 and control = 0.|Baseline to 3 months||||.96
72383538|NCT00809354|144275219|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.07||0.001|TWO_SIDED|95.0|-0.36|-0.09|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.09|-0.36|0.001
72383539|NCT00809354|144275219|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.37|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|95.0|-0.51|-0.24|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.24|-0.51|<0.001
72383540|NCT00809354|144275219|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.07||0.055|TWO_SIDED|95.0|-0.27|0.0|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.00|-0.27|0.055
72618731|NCT01026038|144768109|SUPERIORITY_OR_OTHER||GMT ratio|0.9|||||TWO_SIDED|95.0|0.7|1.2||||||Serotype 18C: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.20|0.70|
72618732|NCT01026038|144768109|SUPERIORITY_OR_OTHER||GMT ratio|0.8|||||TWO_SIDED|95.0|0.61|1.15||||||Serotype 18C: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.15|0.61|
72618733|NCT01026038|144768109|SUPERIORITY_OR_OTHER||GMT ratio|0.8|||||TWO_SIDED|95.0|0.51|1.15||||||Serotype 19F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||1.15|0.51|
72383541|NCT00809354|144275219|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.07||0.038|TWO_SIDED|95.0|-0.28|-0.01|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.01|-0.28|0.038
72383542|NCT00809354|144275219|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.07||0.007|TWO_SIDED|95.0|-0.33|-0.05|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.05|-0.33|0.007
72383543|NCT00809354|144275219|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.28|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|95.0|-0.42|-0.14|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.14|-0.42|<0.001
72383544|NCT00809354|144275220|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.04|STANDARD_ERROR_OF_MEAN|0.06||0.469|TWO_SIDED|95.0|-0.08|0.17|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.17|-0.08|0.469
72383545|NCT00809354|144275220|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.05|STANDARD_ERROR_OF_MEAN|0.06||0.387|TWO_SIDED|95.0|-0.18|0.07|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.07|-0.18|0.387
72383546|NCT00809354|144275220|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.01|STANDARD_ERROR_OF_MEAN|0.06||0.887|TWO_SIDED|95.0|-0.11|0.13|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.13|-0.11|0.887
72383547|NCT00809354|144275220|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.11|STANDARD_ERROR_OF_MEAN|0.06||0.084|TWO_SIDED|95.0|-0.01|0.23|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.23|-0.01|0.084
72383548|NCT00809354|144275220|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.16|STANDARD_ERROR_OF_MEAN|0.07||0.018|TWO_SIDED|95.0|0.03|0.29|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.29|0.03|0.018
72383549|NCT00809354|144275220|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.02|STANDARD_ERROR_OF_MEAN|0.07||0.783|TWO_SIDED|95.0|-0.11|0.15|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.15|-0.11|0.783
72383550|NCT00809354|144275220|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.02|STANDARD_ERROR_OF_MEAN|0.07||0.762|TWO_SIDED|95.0|-0.11|0.15|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.15|-0.11|0.762
72383551|NCT00809354|144275220|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.16|STANDARD_ERROR_OF_MEAN|0.07||0.017|TWO_SIDED|95.0|0.03|0.29|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.29|0.03|0.017
72383552|NCT00809354|144275220|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.11|STANDARD_ERROR_OF_MEAN|0.06||0.091|TWO_SIDED|95.0|-0.23|0.02|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.02|-0.23|0.091
72383553|NCT00809354|144275220|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.16|STANDARD_ERROR_OF_MEAN|0.06||0.009|TWO_SIDED|95.0|-0.29|-0.04|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.04|-0.29|0.009
72383554|NCT00809354|144275220|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.01|STANDARD_ERROR_OF_MEAN|0.06||0.835|TWO_SIDED|95.0|-0.13|0.11|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.11|-0.13|0.835
72383555|NCT00809354|144275220|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.05|STANDARD_ERROR_OF_MEAN|0.06||0.463|TWO_SIDED|95.0|-0.08|0.17|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.17|-0.08|0.463
72383556|NCT00809354|144275220|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.02|STANDARD_ERROR_OF_MEAN|0.07||0.713|TWO_SIDED|95.0|-0.16|0.11|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.11|-0.16|0.713
72383557|NCT00809354|144275220|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.08|STANDARD_ERROR_OF_MEAN|0.07||0.267|TWO_SIDED|95.0|-0.21|0.06|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.06|-0.21|0.267
72435340|NCT03670602|144383658|SUPERIORITY|||||||0.65||||||This is for the treatment group x time effect, or if treatment differentially influenced relative reinforcing efficacy of unhealthy food across all three timepoints. The threshold for statistical significance was p = 0.05|Mixed Models Analysis|Analyses were Intention to Treat (ITT) and included all randomized participants||A mixed model ANCOVA with unstructured covariance and random effects of participant. Group and cohort were the between subject variables, weeks as the repeated measure and site as a covariate||||0.650
72435341|NCT03670602|144383658|SUPERIORITY||||||<|0.0001||||||This is for the time effect, or if time influenced changes in relative reinforcing efficacy of unhealthy food, independent of treatment group. The threshold for statistical significance was p = 0.05|Mixed Models Analysis|Analyses were Intention to Treat (ITT) and included all randomized participants||A mixed model ANCOVA with unstructured covariance and random effects of participant. Group and cohort were the between subject variables, weeks as the repeated measure and site as a covariate||||<0.0001
72435342|NCT01456936|144383659|SUPERIORITY_OR_OTHER|||||||0.0652||||||An interaction between treatment and cohort was considered significant at 10% level. No multiplicity adjustments were utilized.|Regression, Linear|A generalized linear regression analysis based on the safety analysis set was used to evaluate incidence of NPS AE as the primary analysis.||The reduced (final) statistical model included treatment group, cohort and region, plus the 2-way interaction of treatment by cohort. Other interactions not included due to lack of significance. Region reduced to 2-level to address event sparseness issue.||||0.0652
72435343|NCT01456936|144383660|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-1.28|||||TWO_SIDED|95.0|-2.4|-0.15|||Regression, Linear||Risk difference for varenicline versus placebo from estimation model.|Non-psychiatric cohort||-0.15|-2.40|
72435344|NCT01456936|144383660|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.08|||||TWO_SIDED|95.0|-1.37|1.21|||Regression, Linear||Risk difference for bupropion 150 mg BID versus placebo from estimation model.|Non-psychiatric cohort||1.21|-1.37|
72435345|NCT01456936|144383660|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.21|||||TWO_SIDED|95.0|-1.54|1.12|||Regression, Linear||Risk difference for NRT versus placebo from estimation model.|Non-psychiatric cohort||1.12|-1.54|
72435346|NCT01456936|144383660|SUPERIORITY_OR_OTHER||Risk Difference (RD)|1.59|||||TWO_SIDED|95.0|-0.42|3.59|||Regression, Linear||Risk difference for varenicline versus placebo from estimation model|Psychiatric cohort||3.59|-0.42|
72435347|NCT01456936|144383660|SUPERIORITY_OR_OTHER||Risk Difference (RD)|1.78|||||TWO_SIDED|95.0|-0.24|3.81|||Regression, Linear||Risk difference for bupropion 150 mg BID versus placebo from estimation model.|Psychiatric cohort||3.81|-0.24|
72435348|NCT01456936|144383660|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.37|||||TWO_SIDED|95.0|-1.53|2.26|||Regression, Linear||Risk difference for NRT versus placebo from estimation model.|Psychiatric cohort||2.26|-1.53|
72435349|NCT01456936|144383675|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.0|||<|0.0001|TWO_SIDED|95.0|3.2|5.0||No multiplicity adjustment.|Regression, Logistic|||The analysis was done using a logistic regression with terms treatment, cohort, region, treatment by cohort interaction, and region by cohort interaction. Region reduced to 2-level for consistency with primary safety model.||5.00|3.20|<0.0001
72435350|NCT01456936|144383675|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.26|||<|0.0001|TWO_SIDED|95.0|1.8|2.85||No multiplicity adjustment.|Regression, Logistic|||The analysis was done using a logistic regression with terms treatment, cohort, region, treatment by cohort interaction, and region by cohort interaction. Region reduced to 2-level for consistency with primary safety model.||2.85|1.80|<0.0001
72494294|NCT01077973|144517418|SUPERIORITY_OR_OTHER||Difference in proportion|-1.65||||0.786|TWO_SIDED|95.0|-13.45|10.14||p-value was calculated using CMH test which was adjusted for baseline PSR, and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||2 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||10.14|-13.45|0.786
72494295|NCT01077973|144517418|SUPERIORITY_OR_OTHER||Difference in proportion|-4.25||||0.556|TWO_SIDED|95.0|-17.82|9.33||p-value was calculated using CMH test which was adjusted for baseline PSR, and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||3 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||9.33|-17.82|0.556
72494296|NCT01077973|144517418|SUPERIORITY_OR_OTHER||Difference in proportion|-2.77||||0.689|TWO_SIDED|95.0|-16.24|10.69||p-value was calculated using CMH test which was adjusted for baseline PSR, and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||3 hours: Treatment difference \[Ibuprofen (Motrin IB) - placebo\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||10.69|-16.24|0.689
72494297|NCT01077973|144517418|SUPERIORITY_OR_OTHER||Difference in proportion|-1.65||||0.786|TWO_SIDED|95.0|-13.45|10.14||p-value was calculated using CMH test which was adjusted for baseline PSR, and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||3 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||10.14|-13.45|0.786
72494298|NCT01077973|144517421|SUPERIORITY_OR_OTHER||Difference in proportion|3.89||||0.355|TWO_SIDED|95.0|-3.33|11.1||p-value was calculated using CMH test which was adjusted for baseline PSR, and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1 hour: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||11.10|-3.33|0.355
72494299|NCT01077973|144517421|SUPERIORITY_OR_OTHER||Difference in proportion|-1.21||||0.623|TWO_SIDED|95.0|-6.62|4.2||p-value was calculated using CMH test which was adjusted for baseline PSR, and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1 hour: Treatment difference \[Ibuprofen (Motrin IB) - placebo\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||4.20|-6.62|0.623
72494300|NCT01077973|144517421|SUPERIORITY_OR_OTHER||Difference in proportion|5.1||||0.094|TWO_SIDED|95.0|-0.9|11.11||p-value was calculated using CMH test which was adjusted for baseline PSR, and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1 hour: Treatment difference \[Ibuprofen sodium - Ibuprofen (Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||11.11|-0.90|0.094
72383558|NCT00809354|144275220|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.04|STANDARD_ERROR_OF_MEAN|0.07||0.552|TWO_SIDED|95.0|-0.17|0.09|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.09|-0.17|0.552
72383559|NCT00809354|144275220|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.01|STANDARD_ERROR_OF_MEAN|0.07||0.885|TWO_SIDED|95.0|-0.12|0.14|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.14|-0.12|0.885
72383560|NCT00809354|144275220|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.13|STANDARD_ERROR_OF_MEAN|0.07||0.47|TWO_SIDED|95.0|-0.26|0.0|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.00|-0.26|0.47
72383561|NCT00809354|144275220|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.13|STANDARD_ERROR_OF_MEAN|0.07||0.056|TWO_SIDED|95.0|-0.26|0.0|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.00|-0.26|0.056
72383562|NCT00809354|144275220|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.07||0.117|TWO_SIDED|95.0|-0.24|0.03|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.03|-0.24|0.117
72383563|NCT00809354|144275220|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.11|STANDARD_ERROR_OF_MEAN|0.07||0.106|TWO_SIDED|95.0|-0.24|0.02|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.02|-0.24|0.106
72383564|NCT00809354|144275220|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.03|STANDARD_ERROR_OF_MEAN|0.07||0.673|TWO_SIDED|95.0|-0.16|0.1|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.10|-0.16|0.673
72383565|NCT00809354|144275220|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.11|STANDARD_ERROR_OF_MEAN|0.07||0.089|TWO_SIDED|95.0|-0.25|0.02|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.02|-0.25|0.089
72383566|NCT00809354|144275220|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.12|STANDARD_ERROR_OF_MEAN|0.07||0.065|TWO_SIDED|95.0|-0.26|0.01|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.01|-0.26|0.065
72383567|NCT00809354|144275220|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.04|STANDARD_ERROR_OF_MEAN|0.07||0.567|TWO_SIDED|95.0|-0.17|0.09|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.09|-0.17|0.567
72383568|NCT00809354|144275220|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.07||0.135|TWO_SIDED|95.0|-0.24|0.03|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.03|-0.24|0.135
72383569|NCT00809354|144275220|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.12|STANDARD_ERROR_OF_MEAN|0.07||0.094|TWO_SIDED|95.0|-0.25|0.02|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.02|-0.25|0.094
72383570|NCT00809354|144275220|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.13|STANDARD_ERROR_OF_MEAN|0.07||0.055|TWO_SIDED|95.0|-0.27|0.0|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.00|-0.27|0.055
72383571|NCT00809354|144275220|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.12|STANDARD_ERROR_OF_MEAN|0.07||0.087|TWO_SIDED|95.0|-0.25|0.02|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.02|-0.25|0.087
72383572|NCT00809354|144275220|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.04|STANDARD_ERROR_OF_MEAN|0.07||0.542|TWO_SIDED|95.0|-0.18|0.1|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.10|-0.18|0.542
72383573|NCT00809354|144275220|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.03|STANDARD_ERROR_OF_MEAN|0.07||0.643|TWO_SIDED|95.0|-0.17|0.11|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.11|-0.17|0.643
72435351|NCT01456936|144383675|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.3|||<|0.0001|TWO_SIDED|95.0|1.83|2.9||No multiplicity adjustment.|Regression, Logistic|||The analysis was done using a logistic regression with terms treatment, cohort, region, treatment by cohort interaction, and region by cohort interaction. Region reduced to 2-level for consistency with primary safety model.||2.90|1.83|<0.0001
72383574|NCT00809354|144275220|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.07|STANDARD_ERROR_OF_MEAN|0.07||0.301|TWO_SIDED|95.0|-0.21|0.07|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.07|-0.21|0.301
72383575|NCT00809354|144275220|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.08|STANDARD_ERROR_OF_MEAN|0.07||0.237|TWO_SIDED|95.0|-0.22|0.05|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.05|-0.22|0.237
72383576|NCT00809354|144275220|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.06|STANDARD_ERROR_OF_MEAN|0.06||0.36|TWO_SIDED|95.0|-0.18|0.06|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.06|-0.18|0.360
72383577|NCT00809354|144275220|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.01|STANDARD_ERROR_OF_MEAN|0.06||0.854|TWO_SIDED|95.0|-0.13|0.11|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.11|-0.13|0.854
72383578|NCT00809354|144275220|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.11|STANDARD_ERROR_OF_MEAN|0.06||0.076|TWO_SIDED|95.0|-0.23|0.01|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.01|-0.23|0.076
72435352|NCT01456936|144383676|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.24|||<|0.0001|TWO_SIDED|95.0|2.56|4.11||No multiplicity adjustment.|Regression, Logistic|||The analysis was done using a logistic regression with terms treatment, cohort, region, treatment by cohort interaction, and region by cohort interaction. Region reduced to 2-level for consistency with primary safety model.||4.11|2.56|<0.0001
72558035|NCT03703258|144645492|SUPERIORITY||Cohen's D|-0.15|||||TWO_SIDED||||||||Post-intervention between-group Cohen's d; calculated as within-group d(intervention) - within group d(control). Standardized using the standard deviation of the change scores. Negative values favor intervention and positive values favor control.|Baseline to post-intervention only||||
72435353|NCT01456936|144383676|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.87|||<|0.0001|TWO_SIDED|95.0|1.46|2.39||No multiplicity adjustment.|Regression, Logistic|||The analysis was done using a logistic regression with terms treatment, cohort, region, treatment by cohort interaction, and region by cohort interaction. Region reduced to 2-level for consistency with primary safety model.||2.39|1.46|<0.0001
72435354|NCT01456936|144383676|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.0|||<|0.0001|TWO_SIDED|95.0|1.56|2.55||No multiplicity adjustment.|Regression, Logistic|||The analysis was done using a logistic regression with terms treatment, cohort, region, treatment by cohort interaction, and region by cohort interaction. Region reduced to 2-level for consistency with primary safety model.||2.55|1.56|<0.0001
72435355|NCT01456936|144383677|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.61|||<|0.0001|TWO_SIDED|95.0|3.07|4.24||No multiplicity adjustment.|Regression, Logistic|||The analysis was done using a logistic regression with terms treatment and region. Region reduced to 2-level for consistency with primary safety model.||4.24|3.07|<0.0001
72435356|NCT01456936|144383677|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.07|||<|0.0001|TWO_SIDED|95.0|1.75|2.45||No multiplicity adjustment.|Regression, Logistic|||The analysis was done using a logistic regression with terms treatment and region. Region reduced to 2-level for consistency with primary safety model.||2.45|1.75|<0.0001
72435357|NCT01456936|144383677|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.15|||<|0.0001|TWO_SIDED|95.0|1.82|2.54||No multiplicity adjustment.|Regression, Logistic|||The analysis was done using a logistic regression with terms treatment and region. Region reduced to 2-level for consistency with primary safety model.||2.54|1.82|<0.0001
72435358|NCT01456936|144383678|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.99|||<|0.0001|TWO_SIDED|95.0|2.33|3.83||No multiplicity adjustment.|Regression, Logistic|||The analysis was done using a logistic regression with terms treatment, cohort, region, treatment by cohort interaction, and region by cohort interaction. Region reduced to 2-level for consistency with primary safety model.||3.83|2.33|<0.0001
72435359|NCT01456936|144383678|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.0|||<|0.0001|TWO_SIDED|95.0|1.54|2.59||No multiplicity adjustment.|Regression, Logistic|||The analysis was done using a logistic regression with terms treatment, cohort, region, treatment by cohort interaction, and region by cohort interaction. Region reduced to 2-level for consistency with primary safety model.||2.59|1.54|<0.0001
72435360|NCT01456936|144383678|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.96|||<|0.0001|TWO_SIDED|95.0|1.51|2.54||No multiplicity adjustment.|Regression, Logistic|||The analysis was done using a logistic regression with terms treatment, cohort, region, treatment by cohort interaction, and region by cohort interaction. Region reduced to 2-level for consistency with primary safety model.||2.54|1.51|<0.0001
72435361|NCT01456936|144383679|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.5|||<|0.0001|TWO_SIDED|95.0|1.9|3.29||No multiplicity adjustment.|Regression, Logistic|||The analysis was done using a logistic regression with terms treatment, cohort, region, treatment by cohort interaction, and region by cohort interaction. Region reduced to 2-level for consistency with primary safety model.||3.29|1.90|<0.0001
72435362|NCT01456936|144383679|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.77|||<|0.0001|TWO_SIDED|95.0|1.33|2.36||No multiplicity adjustment.|Regression, Logistic|||The analysis was done using a logistic regression with terms treatment, cohort, region, treatment by cohort interaction, and region by cohort interaction. Region reduced to 2-level for consistency with primary safety model.||2.36|1.33|<0.0001
72435363|NCT01456936|144383679|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.65|||<|0.0001|TWO_SIDED|95.0|1.24|2.2||No multiplicity adjustment.|Regression, Logistic|||The analysis was done using a logistic regression with terms treatment, cohort, region, treatment by cohort interaction, and region by cohort interaction. Region reduced to 2-level for consistency with primary safety model.||2.20|1.24|<0.0001
72435364|NCT01456936|144383680|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.74|||<|0.0001|TWO_SIDED|95.0|2.28|3.3||No multiplicity adjustment.|Regression, Logistic|||The analysis was done using a logistic regression with terms treatment and region. Region reduced to 2-level for consistency with primary safety model.||3.30|2.28|<0.0001
72435365|NCT01456936|144383680|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.89|||<|0.0001|TWO_SIDED|95.0|1.56|2.29||No multiplicity adjustment.|Regression, Logistic|||The analysis was done using a logistic regression with terms treatment and region. Region reduced to 2-level for consistency with primary safety model.||2.29|1.56|<0.0001
72435366|NCT01456936|144383680|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.81|||<|0.0001|TWO_SIDED|95.0|1.49|2.19||No multiplicity adjustment.|Regression, Logistic|||The analysis was done using a logistic regression with terms treatment and region. Region reduced to 2-level for consistency with primary safety model.||2.19|1.49|<0.0001
72435367|NCT00543725|144383684|NON_INFERIORITY_OR_EQUIVALENCE|If the lower limit of the 95% 2-sided confidence interval of the difference in proportions (TMC278 - EFV) exceeds -12%, non-inferiority of TMC278 versus EFV can be concluded.|Difference in proportion of response|3.7|||<|0.0001||95.0|-1.6|9.0||Significance level was set at 2.5% (one-sided). No adjustment of p-value for multiple comparisons, since there was only single comparison for the primary endpoint.|Regression, Logistic|Logistic regression model included treatment arm and background NRTI regimen as factors, and baseline (log10) viral load as covariate.|Difference in proportion responders was estimated through the logistic regression model.|Assuming a response rate of 75% at 48 weeks for both treatment groups, 340 subjects were needed per treatment (TMC278 or EFV) to establish non-inferiority of TMC278 versus EFV with a maximum allowable difference of 12% and a 1-sided significance level of 2.5%, to yield 95% power.||9.0|-1.6|<0.0001
72494301|NCT01077973|144517421|SUPERIORITY_OR_OTHER||Difference in proportion|4.43||||0.565|TWO_SIDED|95.0|-10.43|19.29||p-value was calculated using CMH test which was adjusted for baseline PSR, and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||2 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||19.29|-10.43|0.565
72494302|NCT01077973|144517421|SUPERIORITY_OR_OTHER||Difference in proportion|-2.09||||0.765|TWO_SIDED|95.0|-16.15|11.97||p-value was calculated using CMH test which was adjusted for baseline PSR, and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||2 hours: Treatment difference \[Ibuprofen (Motrin IB) - placebo\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||11.97|-16.15|0.765
72435368|NCT00543725|144383685|NON_INFERIORITY_OR_EQUIVALENCE|If the lower limit of the 95% 2-sided confidence interval of the difference in proportions (TMC278 - EFV) exceeds -12%, non-inferiority of TMC278 versus EFV can be concluded.|Difference in proportion of response|3.9|||<|0.0001||95.0|-1.9|9.6|||Regression, Logistic|Logistic regression model included treatment arm and background NRTI regimen as factors, and baseline (log10) viral load as covariate.|Difference in proportion responders was estimated through the logistic regression model.|||9.6|-1.9|<0.0001
72494303|NCT01077973|144517421|SUPERIORITY_OR_OTHER||Difference in proportion|6.47||||0.288|TWO_SIDED|95.0|-5.43|18.37||p-value was calculated using CMH test which was adjusted for baseline PSR, and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||2 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||18.37|-5.43|0.288
72558036|NCT03703258|144645492|SUPERIORITY||Cohen's D|0.003|||||TWO_SIDED||||||||3 month between-group Cohen's d; calculated as within-group d(intervention) - within group d(control). Standardized using the standard deviation of the change scores. Negative values favor intervention and positive values favor control.|Baseline to 3 months||||
72558037|NCT03703258|144645493|SUPERIORITY||Slope|-0.08|STANDARD_ERROR_OF_MEAN|0.26||0.75|TWO_SIDED||||||Mixed Models Analysis||Post-intervention condition x time interaction coefficient from mixed-effect model using negative binomial distribution. Intervention = 1 and control = 0.|Baseline to post-intervention only||||.75
72558038|NCT03703258|144645493|SUPERIORITY||Slope|-0.12|STANDARD_ERROR_OF_MEAN|0.27||0.64|TWO_SIDED||||||Mixed Models Analysis||3 month condition x time interaction coefficient from mixed-effect model using negative binomial distribution. Intervention = 1 and control = 0.|Baseline to 3 months||||.64
72383579|NCT00809354|144275220|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.06||0.957|TWO_SIDED|95.0|-0.12|0.12|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.12|-0.12|0.957
72383580|NCT00809354|144275220|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.06|STANDARD_ERROR_OF_MEAN|0.07||0.404|TWO_SIDED|95.0|-0.19|0.08|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.08|-0.19|0.404
72383581|NCT00809354|144275220|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.1|STANDARD_ERROR_OF_MEAN|0.07||0.128|TWO_SIDED|95.0|-0.03|0.23|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.23|-0.03|0.128
72383582|NCT00809354|144275220|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.04|STANDARD_ERROR_OF_MEAN|0.07||0.577|TWO_SIDED|95.0|-0.17|0.09|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.09|-0.17|0.577
72383583|NCT00809354|144275220|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.12|STANDARD_ERROR_OF_MEAN|0.07||0.068|TWO_SIDED|95.0|-0.01|0.25|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.25|-0.01|0.068
72383584|NCT00809354|144275220|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.15|STANDARD_ERROR_OF_MEAN|0.06||0.016|TWO_SIDED|95.0|-0.27|-0.03|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.03|-0.27|0.016
72383585|NCT00809354|144275220|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.26|STANDARD_ERROR_OF_MEAN|0.06|<|0.001|TWO_SIDED|95.0|-0.38|-0.13|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.13|-0.38|<0.001
72383586|NCT00809354|144275220|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.31|STANDARD_ERROR_OF_MEAN|0.06|<|0.001|TWO_SIDED|95.0|-0.44|-0.19|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.19|-0.44|<0.001
72383587|NCT00809354|144275220|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.27|STANDARD_ERROR_OF_MEAN|0.06|<|0.001|TWO_SIDED|95.0|-0.39|-0.15|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.15|-0.39|<0.001
72383588|NCT00809354|144275220|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.14|STANDARD_ERROR_OF_MEAN|0.07||0.037|TWO_SIDED|95.0|-0.27|-0.01|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.01|-0.27|0.037
72383589|NCT00809354|144275220|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.17|STANDARD_ERROR_OF_MEAN|0.07||0.015|TWO_SIDED|95.0|-0.3|-0.03|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.03|-0.30|0.015
72383590|NCT00809354|144275220|SUPERIORITY_OR_OTHER_LEGACY||0.07|-0.22||||0.001|TWO_SIDED|95.0|-0.35|-0.08|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.08|-0.35|0.001
72383591|NCT00809354|144275220|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.21|STANDARD_ERROR_OF_MEAN|0.07||0.002|TWO_SIDED|95.0|-0.34|-0.07|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.07|-0.34|0.002
72383592|NCT00809354|144275220|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.14|STANDARD_ERROR_OF_MEAN|0.07||0.042|TWO_SIDED|95.0|-0.27|0.0|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.00|-0.27|0.042
72383593|NCT00809354|144275220|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.27|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|95.0|-0.4|-0.14|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.14|-0.40|<0.001
72383594|NCT00809354|144275220|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.26|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|95.0|-0.4|-0.13|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.13|-0.40|<0.001
72383595|NCT00809354|144275220|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.37|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|95.0|-0.5|-0.24|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.24|-0.50|<0.001
72435369|NCT00543725|144383686|NON_INFERIORITY_OR_EQUIVALENCE|If the lower limit of the 95% 2-sided confidence interval of the difference in proportions (TMC278 - EFV) exceeds -12%, non-inferiority of TMC278 versus EFV can be concluded.|Difference in proportion of response|2.4|||<|0.0001||95.0|-3.6|8.4||Significance level was set at 2.5% (one-sided). No adjustment of p-value for multiple comparisons, since there was only single comparison for the primary endpoint.|Regression, Logistic|Logistic regression model included treatment arm and background NRTI regimen as factors, and baseline (log10) viral load as covariate.|Difference in proportion responders was estimated through the logistic regression model.|Assuming a response rate of 75% at 48 weeks for both treatment groups, 340 subjects were needed per treatment (TMC278 or EFV) to establish non-inferiority of TMC278 versus EFV with a maximum allowable difference of 12% and a 1-sided significance level of 2.5%, to yield 95% power.||8.4|-3.6|<0.0001
72494304|NCT01077973|144517421|SUPERIORITY_OR_OTHER||Difference in proportion|-0.87||||0.928|TWO_SIDED|95.0|-20.0|18.27||p-value was calculated using CMH test which was adjusted for baseline PSR, and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||3 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||18.27|-20.00|0.928
72494305|NCT01077973|144517421|SUPERIORITY_OR_OTHER||Difference in proportion|-6.4||||0.495|TWO_SIDED|95.0|-25.14|12.33||p-value was calculated using CMH test which was adjusted for baseline PSR, and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||3 hours: Treatment difference \[Ibuprofen (Motrin IB) - placebo\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||12.33|-25.14|0.495
72494306|NCT01077973|144517421|SUPERIORITY_OR_OTHER||Difference in proportion|5.46||||0.477|TWO_SIDED|95.0|-9.66|20.59||p-value was calculated using CMH test which was adjusted for baseline PSR, and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||3 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||20.59|-9.66|0.477
72494307|NCT00119158|144517439|NON_INFERIORITY_OR_EQUIVALENCE|modified EASI (eczema area severity index) was considered equivalent if p value was greater than \>0.05|||||<|0.05||95.0|||||t-test, 2 sided|||||||<0.05
72383596|NCT00809354|144275220|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.09|STANDARD_ERROR_OF_MEAN|0.07||0.182|TWO_SIDED|95.0|-0.22|0.04|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.04|-0.22|0.182
72383597|NCT00809354|144275220|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.12|STANDARD_ERROR_OF_MEAN|0.07||0.08|TWO_SIDED|95.0|-0.25|0.01|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.01|-0.25|0.080
72383598|NCT00809354|144275220|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.07||0.002|TWO_SIDED|95.0|-0.34|-0.07|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.07|-0.34|0.002
72383599|NCT00809354|144275220|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.24|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|95.0|-0.37|-0.11|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.11|-0.37|<0.001
72383600|NCT00809354|144275220|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.17|STANDARD_ERROR_OF_MEAN|0.07||0.016|TWO_SIDED|95.0|-0.3|-0.03|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.03|-0.30|0.016
72383601|NCT00809354|144275220|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.27|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|95.0|-0.4|-0.13|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.13|-0.40|<0.001
72383602|NCT00809354|144275220|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.28|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|95.0|-0.42|-0.15|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.15|-0.42|<0.001
72383603|NCT00809354|144275220|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|95.0|-0.53|-0.27|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.27|-0.53|<0.001
72383604|NCT00809354|144275220|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.15|STANDARD_ERROR_OF_MEAN|0.07||0.032|TWO_SIDED|95.0|-0.29|-0.01|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.01|-0.29|0.032
72383605|NCT00809354|144275220|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.19|STANDARD_ERROR_OF_MEAN|0.07||0.006|TWO_SIDED|95.0|-0.33|-0.06|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.06|-0.33|0.006
72383606|NCT00809354|144275220|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.18|STANDARD_ERROR_OF_MEAN|0.07||0.009|TWO_SIDED|95.0|-0.32|-0.05|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.05|-0.32|0.009
72383607|NCT00809354|144275220|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.27|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|95.0|-0.41|-0.13|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.13|-0.41|<0.001
72383608|NCT00100178|144275264|SUPERIORITY_OR_OTHER_LEGACY|||||||0.47|||||||ANCOVA|||"The calculation for the concentration of c-peptide is a weighted average of the 6 timed measurements of c-peptide in nano-moles/Liter. We try to distinguish this calculation from the AUC by referring to it as the AUC mean and may be expressed algebraically as the AUC/(120 min.); thus, the units are the same as the y-axis."||||0.47
72383609|NCT01439568|144275278|SUPERIORITY||Hazard Ratio (HR)|1.0608||||0.8072|TWO_SIDED|95.0|0.6598|1.7055|||Logrank Test|||||1.7055|0.6598|0.8072
72383610|NCT02439879|144275325|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||paired t test|||All data were analyzed using the SPSS v16 statistical package software. To compare categorical variables, the chi2 test was used, and, for continuous variables,the T-test for independent or paired samples was applied.Data are expressed as percent values with 95% confidence intervals (CI) or mean ± SD or mean ± SEM||||< 0.05
72383611|NCT02617888|144275394|SUPERIORITY||Slope|0.08|||<|0.05|TWO_SIDED||||||Regression, Linear|||||||<0.05
72558039|NCT03703258|144645493|SUPERIORITY||Cohen's D|-0.12|||||TWO_SIDED||||||||Post-intervention between-group Cohen's d; calculated as within-group d(intervention) - within group d(control). Standardized using the standard deviation of the change scores. Negative values favor intervention and positive values favor control.|Baseline to post-intervention only||||
72558040|NCT03703258|144645493|SUPERIORITY||Cohen's D|-0.16|||||TWO_SIDED||||||||3 month between-group Cohen's d; calculated as within-group d(intervention) - within group d(control). Standardized using the standard deviation of the change scores. Negative values favor intervention and positive values favor control.|Baseline to 3 months||||
72383612|NCT02448810|144275443|OTHER||Hazard Ratio (HR)|0.8||||0.246|TWO_SIDED|70.0|0.5|1.1||P-value is based on a one-sided log-rank test.|Log Rank||||Hazard Ratio and 70% CI are based on a Cox proportional hazards model with a covariate for treatment (imalumab vs SoC).|1.1|0.5|0.246
72383613|NCT02448810|144275443|OTHER||Hazard Ratio (HR)|0.8||||0.354|TWO_SIDED|70.0|0.5|1.4||P-value is based on a one-sided log-rank test.|Log Rank||||Hazard Ratio and 70% CI are based on a Cox proportional hazards model with a covariate for treatment (imalumab vs SoC).|1.4|0.5|0.354
72383614|NCT04856891|144275472|SUPERIORITY||Percent Difference from Placebo|78.4|||<|0.0001|TWO_SIDED|95.0|62.2|89.1|||Fisher Exact|||||89.1|62.2|<0.0001
72383615|NCT04856891|144275473|SUPERIORITY||LSM Difference from Placebo|0.3||||0.8822|TWO_SIDED|95.0|-4.0|4.7|||Mixed Models Analysis|||||4.7|-4.0|0.8822
72383616|NCT04856891|144275474|SUPERIORITY||LSM Difference from Placebo|-74.9|||<|0.0001|TWO_SIDED|95.0|-85.2|-64.7|||ANCOVA|||||-64.7|-85.2|<0.0001
72383617|NCT04856891|144275475|SUPERIORITY||Percent Difference from Placebo|80.4|||<|0.0001|TWO_SIDED|95.0|64.8|90.6|||Fisher Exact|||||90.6|64.8|<0.0001
72383618|NCT04856891|144275476|SUPERIORITY||Percent Difference from Placebo|43.5|||<|0.0001|TWO_SIDED|95.0|23.5|59.9|||Fisher Exact|||||59.9|23.5|<0.0001
72383619|NCT04856891|144275477|SUPERIORITY||Percent Difference from Placebo|-1.5||||1|TWO_SIDED|95.0|-22.2|18.0|||Fisher Exact|||||18.0|-22.2|1.0000
72383620|NCT04856891|144275478|SUPERIORITY||Percent Difference from Placebo|6.9||||0.4502|TWO_SIDED|95.0|-13.8|26.3|||Fisher Exact|||||26.3|-13.8|0.4502
72383621|NCT04856891|144275479|SUPERIORITY||LSM Difference from Placebo|-3.1||||0.6805|TWO_SIDED|95.0|-18.1|11.8|||Mixed Models Analysis|||Weeks 24 Percent Change from Baseline||11.8|-18.1|0.6805
72383622|NCT00568685|144275480|SUPERIORITY_OR_OTHER|||||||0.0048||95.0||||This is the p value for CGI-ADHD-S score change at endpoint|Mixed Models Analysis|||||||0.0048
72383623|NCT00568685|144275481|SUPERIORITY_OR_OTHER|||||||0.0153||95.0||||This is the p value for CGI-ADHD-I score change at endpoint|Mixed Models Analysis|||||||0.0153
72383624|NCT00568685|144275482|SUPERIORITY_OR_OTHER|||||||0.45||95.0||||P-value relates to the sum of adverse events leading to discontinuation.|Fisher Exact|||||||.4500
72383625|NCT00568685|144275483|SUPERIORITY_OR_OTHER|||||||0.024||95.0|||||ANCOVA|||||||0.0240
72383626|NCT00568685|144275485|SUPERIORITY_OR_OTHER|||||||0.8005||95.0||||This is the p value for heart rate change at endpoint|ANOVA|||||||0.8005
72383627|NCT00568685|144275486|SUPERIORITY_OR_OTHER|||||||0.4128||95.0||||This is the p value for temperature change at endpoint|ANOVA|||||||0.4128
72383628|NCT00568685|144275487|SUPERIORITY_OR_OTHER|||||||0.9761||95.0||||This is the p value for systolic change at endpoint|ANOVA|||||||0.9761
72383629|NCT00568685|144275487|SUPERIORITY_OR_OTHER|||||||0.6419||95.0||||This is the p value for diastolic change at endpoint|ANOVA|||||||0.6419
72383630|NCT00568685|144275488|SUPERIORITY_OR_OTHER|||||||0.2213||95.0||||This is the p value for weight change at endpoint|ANOVA|||||||0.2213
72383631|NCT02787551|144275502|SUPERIORITY||Least square (LS) mean difference|-0.64|STANDARD_ERROR_OF_MEAN|0.067|<|0.0001|TWO_SIDED|95.0|-0.77|-0.508||Threshold for significance at 0.05 level.|Mixed Models Analysis|||Analysis was performed using Mixed-effect model with repeated measures (MMRM) with treatment groups, randomization strata of Week -2 HbA1c (\<8.0%, \>=8.0%), GLP-1 RA subtype at screening, visits, treatment-by-visit interaction, world region as fixed effects, baseline HbA1c value-by-visit interaction as a covariate. Analysis included all scheduled measurements obtained during 26-week randomized treatment period, including those obtained after IMP discontinuation/introduction of rescue medication.||-0.508|-0.770|<0.0001
72383632|NCT02787551|144275504|SUPERIORITY||Difference in percentage|36.05|||<|0.0001|TWO_SIDED|95.0|28.11|43.99||Threshold for significance \<=0.05|Cochran-Mantel-Haenszel|||HbA1c \<7.0%: Insulin Glargine/Lixisenatide FRC vs GLP-1 Receptor Agonist. Analysis was performed using Cochran-Mantel-Haenszel method method stratified on randomization strata of Week -2 HbA1c (\<8.0%, \>=8.0%), and randomization strata of GLP-1 receptor agonist subtype at screening. Hierarchical testing procedure was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially per pre-specified order (only HbA1c \< 7% was part of testing).||43.99|28.11|<.0001
72383633|NCT02787551|144275506|SUPERIORITY||LS Mean Difference|-1.67|STANDARD_ERROR_OF_MEAN|0.168|<|0.0001|TWO_SIDED|95.0|-2.001|-1.341||Threshold for significance at 0.05 level.|Mixed Models Analysis|||Analysis was performed using MMRM with treatment groups, randomization strata of Week -2 HbA1c (\<8.0%, \>=8.0%), randomization strata of GLP-1 RA subtype at screening, scheduled visit, treatment-by-visit interaction, and world region as fixed effects, and and baseline FPG value-by visit interaction as a covariate. Testing according to the hierarchical testing procedure (continued only if previous outcome measures were statistically significant).||-1.341|-2.001|<0.0001
72383634|NCT02787551|144275508|SUPERIORITY||LS Mean Difference|-1.02|STANDARD_ERROR_OF_MEAN|0.157|<|0.0001|TWO_SIDED|95.0|-1.325|-0.708||Threshold for significance at 0.05 level.|Mixed Models Analysis|||Analysis was performed using MMRM with treatment groups, randomization strata of Week -2 HbA1c (\<8.0%, \>=8.0%), randomization strata of GLP-1 RA subtype at screening, scheduled visit, treatment-by-visit interaction, and world region as fixed effects, and baseline average SMPG value-by-visit interaction as a covariate. Testing according to the hierarchical testing procedure (continued only if previous outcome measures were statistically significant).||-0.708|-1.325|<0.0001
72558041|NCT03703258|144645494|SUPERIORITY||Slope|0.06|STANDARD_ERROR_OF_MEAN|0.35||0.86|TWO_SIDED||||||Mixed Models Analysis||Post-intervention condition x time interaction coefficient from mixed-effect model using negative binomial distribution. Intervention = 1 and control = 0.|Baseline to post-intervention only||||.86
72558042|NCT03703258|144645494|SUPERIORITY||Slope|-0.22|STANDARD_ERROR_OF_MEAN|0.36||0.55|TWO_SIDED||||||Mixed Models Analysis||3 month condition x time interaction coefficient from mixed-effect model using negative binomial distribution. Intervention = 1 and control = 0.|Baseline to 3 months||||.55
72558043|NCT03703258|144645494|SUPERIORITY||Cohen's D|-0.04|||||TWO_SIDED||||||||Post-intervention between-group Cohen's d; calculated as within-group d(intervention) - within group d(control). Standardized using the standard deviation of the change scores. Negative values favor intervention and positive values favor control.|Baseline to post-intervention only||||
72558044|NCT03703258|144645494|SUPERIORITY||Cohen's D|-0.39|||||TWO_SIDED||||||||3 month between-group Cohen's d; calculated as within-group d(intervention) - within group d(control). Standardized using the standard deviation of the change scores. Negative values favor intervention and positive values favor control.|Baseline to 3 months||||
72558045|NCT01838681|144645557|SUPERIORITY||Odds Ratio (OR)|0.83||||0.2641|TWO_SIDED|95.0|0.6|1.15|||Regression, Logistic|Model included MADRS total score at the randomisation visit, treatment group, country, and the randomisation criteria used||||1.15|0.60|0.2641
72558046|NCT01229150|144645577|SUPERIORITY_OR_OTHER|||||||0.24|||||||Log Rank|||||||0.24
72558047|NCT01229150|144645577|SUPERIORITY_OR_OTHER|||||||0.75|||||||Log Rank|||||||0.75
72558048|NCT01229150|144645581|SUPERIORITY_OR_OTHER|||||||0.51|||||||Log Rank|||||||0.51
72558049|NCT01229150|144645581|SUPERIORITY_OR_OTHER|||||||0.81|||||||Log Rank|||||||0.81
72558050|NCT01229150|144645583|SUPERIORITY_OR_OTHER||||||<|0.0007||||||P-value was determined by comparison by the level of p-ERK at cycle 1 day 1 to cycle 1 day 2.|Wilcoxon matched-pairs signed rank test|||||||<0.0007
72558051|NCT01229150|144645583|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value was determined by comparison by the level of p-ERK at cycle 1 day 1 to cycle 1 day 14.|Wilcoxon matched-pairs signed rank test|||||||<0.0001
72558052|NCT01229150|144645583|SUPERIORITY_OR_OTHER|||||||0.0209||||||P-value was determined by comparison by the level of p-ERK at cycle 1 day 2 and cycle 1 day 14.|Wilcoxon matched-pairs signed rank test|||4 patients in this group; statistically underpowered.||||0.0209
72558053|NCT00902538|144645616|SUPERIORITY_OR_OTHER|||||||0.1187||95.0|||||ANCOVA|||||||0.1187
72558054|NCT00902538|144645616|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||||||<0.0001
72618734|NCT01026038|144768109|SUPERIORITY_OR_OTHER||GMT ratio|0.7|||||TWO_SIDED|95.0|0.46|1.03||||||Serotype 19F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.03|0.46|
72618735|NCT01026038|144768109|SUPERIORITY_OR_OTHER||GMT ratio|0.9|||||TWO_SIDED|95.0|0.56|1.44||||||Serotype 19F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.44|0.56|
72558055|NCT00902538|144645617|SUPERIORITY_OR_OTHER|||||||0.0425||95.0|||||ANCOVA|||||||0.0425
72558056|NCT00902538|144645617|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||||||<0.0001
72558057|NCT00902538|144645618|SUPERIORITY_OR_OTHER|||||||0.1939||95.0|||||Cochran-Mantel-Haenszel|||||||0.1939
72558058|NCT00902538|144645618|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Cochran-Mantel-Haenszel|||||||<0.0001
72558059|NCT00902538|144645619|SUPERIORITY_OR_OTHER|||||||0.0009||95.0|||||ANCOVA|||||||0.0009
72558060|NCT00902538|144645619|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||||||<0.0001
72558061|NCT00902538|144645620|SUPERIORITY_OR_OTHER|||||||0.0001||95.0|||||ANCOVA|||||||0.0001
72558062|NCT00902538|144645620|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||||||<0.0001
72558063|NCT00902538|144645621|SUPERIORITY_OR_OTHER|||||||0.1611||95.0|||||ANCOVA|||||||0.1611
72558064|NCT00902538|144645622|SUPERIORITY_OR_OTHER|||||||0.0451||95.0|||||ANCOVA|||||||0.0451
72558065|NCT00902538|144645623|SUPERIORITY_OR_OTHER|||||||0.0412||95.0|||||ANCOVA|||||||0.0412
72558066|NCT00902538|144645624|SUPERIORITY_OR_OTHER|||||||0.0253||95.0|||||ANCOVA|||||||0.0253
72558067|NCT00902538|144645625|SUPERIORITY_OR_OTHER|||||||0.0063||95.0|||||ANCOVA|||||||0.0063
72558068|NCT00849797|144645632|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|90.86||||||90.0|85.47|96.6|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||96.60|85.47|
72558069|NCT00849797|144645633|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|98.6||||||90.0|96.59|100.66|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||100.66|96.59|
72558070|NCT00849797|144645634|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|98.74||||||90.0|96.71|100.8|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||100.80|96.71|
72558071|NCT00849797|144645635|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|98.5||||||90.0|95.66|100.48|||||Results presented for informational purposes only; metabolite not subjected to bioequivalence criteria.|||100.48|95.66|
72558072|NCT00849797|144645636|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|100.29||||||90.0|98.96|101.64|||||Results presented for informational purposes only, metabolite not subjected to bioequivalence criteria.|||101.64|98.96|
72558073|NCT00849797|144645637|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|100.08||||||90.0|98.91|101.27|||||Results presented for informational purposes only; metabolite not subjected to bioequivalence criteria.|||101.27|98.91|
72558074|NCT00926887|144645646|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Fisher Exact|||||||<0.0001
72558075|NCT00926887|144645649|SUPERIORITY_OR_OTHER||||||<|0.01||95.0|||||t-test, 2 sided|t=-2.711; df=102; p\<0.01||||||<0.01
72558076|NCT00926887|144645653|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|df=102, t=-3.44||||||<0.001
72558077|NCT04198363|144645656|NON_INFERIORITY|Noninferiority of vonoprazan to esomeprazole was evaluated by Farrington and Manning test using a noninferiority margin of 10% for analysis.|Difference in Proportions|0.1|||=|0.0009|TWO_SIDED|95.0|-5.95|6.17|||Farrington and Manning Test||Difference in proportions for vonoprazan versus esomeprazole was analyzed and the 2-sided Wald confidence interval was used for determining the 95% confidence interval.|||6.17|-5.95|=0.0009
72494308|NCT04311086|144517483|OTHER|A propensity score will be estimated for each patient from a multivariable logistic regression model, which is the probability that the patient is in DYSTAL cohort. In this model, the DYSTAL cohort (binary variable) is the outcome variable, and the following covariates will be considered as independent variables for propensity score analysis model: baseline Office and 24-hour ABPM (continuous) SBP and DBP, age (continuous), gender (dichotomous), BMI (continuous), diabetes (dichotomous).|||||>|0.05|||||||ANCOVA|||Comparison to the SPYRAL HTN-OFF MED study (NCT02439749) using a propensity score stratification (sub classification) adjustment.||||>0.05
72494309|NCT04311086|144517484|OTHER|A propensity score will be estimated for each patient from a multivariable logistic regression model, which is the probability that the patient is in DYSTAL cohort. In this model, the DYSTAL cohort (binary variable) is the outcome variable, and the following covariates will be considered as independent variables for propensity score analysis model: baseline Office and 24-hour ABPM (continuous) SBP and DBP, age (continuous), gender (dichotomous), BMI (continuous), diabetes (dichotomous).|||||>|0.05|||||||ANCOVA|||Comparison to the SPYRAL HTN-OFF MED study (NCT02439749) using a propensity score stratification (sub classification) adjustment.||||>0.05
72558078|NCT03067987|144645667|SUPERIORITY||||||<|0.007|||||||ANOVA|||||||<0.007
72618736|NCT01026038|144768109|SUPERIORITY_OR_OTHER||GMT ratio|1.0|||||TWO_SIDED|95.0|0.74|1.37||||||Serotype 23F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||1.37|0.74|
72618737|NCT01026038|144768109|SUPERIORITY_OR_OTHER||GMT ratio|0.9|||||TWO_SIDED|95.0|0.67|1.23||||||Serotype 23F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.23|0.67|
72383635|NCT02787551|144275510|SUPERIORITY||LS Mean Difference|-2.85|STANDARD_ERROR_OF_MEAN|0.29|<|0.0001|TWO_SIDED|95.0|-3.42|-2.279||Threshold for significance at 0.05 level.|ANCOVA|||Analysis was performed using analysis of covariance (ANCOVA) model with treatment groups, randomization strata of Week -2 HbA1c (\<8.0%, \>=8.0%), randomization strata of GLP-1 RA subtype (once/twice daily formulations, once weekly formulations) at screening, and world region as fixed effects and baseline 2-hour PPG value as a covariate. Testing according to the hierarchical testing procedure (continued only if previous endpoints were statistically significant).||-2.279|-3.420|<0.0001
72383636|NCT02787551|144275512|SUPERIORITY||LS Mean Difference|-0.99|STANDARD_ERROR_OF_MEAN|0.244|<|0.0001|TWO_SIDED|95.0|-1.468|-0.508||Threshold for significance at 0.05 level.|ANCOVA|||Analysis was performed using ANCOVA model with treatment groups, randomization strata of Week -2 HbA1c (\<8.0%, \>=8.0%), randomization strata of GLP-1 receptor agonist subtype (once/twice daily formulations, once weekly formulations) at screening, and world region as fixed effects and baseline 2-hour plasma glucose excursion value as a covariate. Testing according to the hierarchical testing procedure (continued only if previous endpoints were statistically significant).||-0.508|-1.468|<0.0001
72383637|NCT02038452|144275520|SUPERIORITY||Mean Difference (Final Values)|-0.32|||<|0.001|TWO_SIDED|95.0|-0.48|-0.16|||Regression, Linear|Multiple imputation for missing data was performed. Linear regression adjusted for baseline score, sex, age, and duration of symptoms.||The main treatment analyses were based on intention to treat approach||-0.16|-0.48|<0.001
72383638|NCT02038452|144275521|SUPERIORITY||Mean Difference (Final Values)|-0.35|||<|0.001|TWO_SIDED|95.0|-0.53|-0.17|||Regression, Linear|Multiple imputation for missing data was performed. Linear regression adjusted for baseline score, sex, age, and duration of symptoms.||The main treatment analyses were based on intention to treat approach||-0.17|-0.53|<0.001
72383639|NCT02038452|144275522|SUPERIORITY||Mean Difference (Final Values)|-0.26||||0.003|TWO_SIDED|95.0|-0.43|-0.09|||Regression, Linear|Multiple imputation for missing data was performed. Linear regression adjusted for baseline score, sex, age, and duration of symptoms.||The main treatment analyses were based on intention to treat approach||-0.09|-0.43|0.003
72383640|NCT02038452|144275523|SUPERIORITY||Mean Difference (Final Values)|-0.97||||0.005|TWO_SIDED|95.0|-1.64|-0.3|||Regression, Linear|Multiple imputation for missing data was performed. Linear regression adjusted for baseline score, sex, age, and duration of symptoms.||The main treatment analyses were based on intention to treat approach||-0.30|-1.64|0.005
72383641|NCT02038452|144275524|SUPERIORITY||Odds Ratio (OR)|0.44||||0.018|TWO_SIDED|95.0|0.22|0.87|||Regression, Logistic|Multiple imputation for missing data was performed. Logistic regression adjusted for baseline score, sex, age, and duration of symptoms.||The main treatment analyses were based on intention to treat approach||0.87|0.22|0.018
72383642|NCT02038452|144275527|SUPERIORITY||Mean Difference (Final Values)|0.06||||0.5|TWO_SIDED|95.0|-0.11|0.23|||Regression, Linear|Multiple imputation for missing data was performed. Linear regression adjusted for baseline score, sex, age, and duration of symptoms.||The main treatment analyses were based on intention to treat approach||0.23|-0.11|0.500
72383643|NCT02038452|144275528|SUPERIORITY||Mean Difference (Final Values)|0.13||||0.21|TWO_SIDED|95.0|-0.07|0.33|||Regression, Linear|Multiple imputation for missing data was performed. Linear regression adjusted for baseline score, sex, age, and duration of symptoms||The main treatment analyses were based on intention to treat approach||0.33|-0.07|0.21
72558079|NCT03067987|144645668|SUPERIORITY|||||||0.0006|||||||ANOVA|||||||0.0006
72558080|NCT03442322|144645671|OTHER|Given that we found baseline differences in resident characteristics and outcomes, we implemented a difference-in-differences model for all outcomes.|Difference-in-Difference estimator|1.25||||0.492|TWO_SIDED||||||Regression, Linear|All regressions controlled for resident characteristics and nursing home fixed effects.||||||0.492
72383644|NCT02038452|144275529|SUPERIORITY||Mean Difference (Final Values)|-0.005||||0.96|TWO_SIDED|95.0|-0.175|0.166|||Regression, Linear|Multiple imputation for missing data was performed. Linear regression adjusted for baseline score, sex, age, and duration of symptoms.||The main treatment analyses were based on intention to treat approach||0.166|-0.175|0.96
72383645|NCT02038452|144275530|SUPERIORITY||Mean Difference (Final Values)|0.79||||0.055|TWO_SIDED|95.0|-0.02|1.59|||Regression, Linear|Multiple imputation for missing data was performed. Linear regression adjusted for baseline score, sex, age, and duration of symptoms.||The main treatment analyses were based on intention to treat approach||1.59|-0.02|0.055
72383646|NCT02038452|144275531|SUPERIORITY||Odds Ratio (OR)|1.12||||0.76|TWO_SIDED|95.0|0.55|2.2|||Regression, Logistic|Multiple imputation for missing data was performed. Logistic regression adjusted for baseline score, sex, age, and duration of symptoms.||The main treatment analyses were based on intention to treat approach||2.20|0.55|0.76
72383647|NCT02038452|144275532|SUPERIORITY||Odds Ratio (OR)|1.66||||0.23|TWO_SIDED|95.0|0.73|3.77|||Regression, Logistic|Multiple imputation for missing data was performed. Logistic regression for sex, age, and duration of symptoms.||The main treatment analyses were based on intention to treat approach||3.77|0.73|0.23
72383648|NCT02038452|144275533|SUPERIORITY||Odds Ratio (OR)|1.28||||0.66|TWO_SIDED|95.0|0.41|3.98|||Regression, Logistic|Multiple imputation for missing data was performed. Logistic regression adjusted for sex, age, and duration of symptoms.||The main treatment analyses were based on intention to treat approach||3.98|0.41|0.66
72383649|NCT02038452|144275534|SUPERIORITY||Odds Ratio (OR)|1.43||||0.66|TWO_SIDED|95.0|0.28|7.34|||Regression, Logistic|Multiple imputation for missing data was performed. Logistic regression adjusted for sex, age, and duration of symptoms.||The main treatment analyses were based on intention to treat approach||7.34|0.28|0.66
72383650|NCT02038452|144275535|SUPERIORITY||Odds Ratio (OR)|1.42||||0.4|TWO_SIDED|95.0|0.63|3.18|||Regression, Logistic|Multiple imputation for missing data was performed. Logistic regression adjusted for sex, age, and duration of symptoms.||The main treatment analyses were based on intention to treat approach||3.18|0.63|0.40
72383651|NCT02038452|144275536|SUPERIORITY||Odds Ratio (OR)|1.99||||0.2|TWO_SIDED|95.0|0.7|5.66|||Regression, Logistic|Multiple imputation for missing data was performed. Logistic regression adjusted for sex, age, and duration of symptoms.||The main treatment analyses were based on intention to treat approach||5.66|0.70|0.20
72383652|NCT02038452|144275537|SUPERIORITY||Mean Difference (Final Values)|-0.34||||0.001|TWO_SIDED|95.0|-0.53|-0.14||Participants with relevant outcomes reported on at least one follow-up time point were included in the analyses. Adjustment was made for baseline score, age, duration of symptoms, interaction term between treatment and follow-up.|Mixed Models Analysis|||||-0.14|-0.53|0.001
72383653|NCT02038452|144275538|SUPERIORITY||Mean Difference (Final Values)|0.03||||0.74|TWO_SIDED|95.0|-0.17|0.24||Participants with relevant outcomes reported on at least one follow-up time point were included in the analyses. Adjustment was made for baseline score, age, duration of symptoms, interaction term between treatment and follow-up.|Mixed Models Analysis|||||0.24|-0.17|0.74
72383654|NCT02038452|144275539|SUPERIORITY||Mean Difference (Final Values)|-0.09||||0.41|TWO_SIDED|95.0|-0.3|0.12||Participants with relevant outcomes reported on at least one follow-up time point were included in the analyses. Adjustment was made for baseline score, age, duration of symptoms, interaction term between treatment and follow-up.|Mixed Models Analysis|||||0.12|-0.30|0.41
72383655|NCT02038452|144275540|SUPERIORITY||Mean Difference (Final Values)|0.06||||0.58|TWO_SIDED|95.0|-0.16|0.28||Participants with relevant outcomes reported on at least one follow-up time point were included in the analyses. Adjustment was made for baseline score, age, duration of symptoms, interaction term between treatment and follow-up.|Mixed Models Analysis|||||0.28|-0.16|0.58
72435370|NCT00543725|144383687|NON_INFERIORITY_OR_EQUIVALENCE|If the lower limit of the 95% 2-sided confidence interval of the difference in proportions (TMC278 - EFV) exceeds -12%, non-inferiority of TMC278 versus EFV can be concluded.|Difference in proportion of response|0.7|||<|0.0001||95.0|-5.6|7.0|||Regression, Logistic|Logistic regression model included treatment arm and background NRTI regimen as factors, and baseline (log10) viral load as covariate.|Difference in proportion responders was estimated through the logistic regression model.|||7.0|-5.6|<0.0001
72435371|NCT00906698|144383702|SUPERIORITY_OR_OTHER||Ratio of adjusted gMean|126.2|||||TWO_SIDED|90.0|69.549|229.012|||ANOVA|||||229.012|69.549|
72383656|NCT02038452|144275541|SUPERIORITY||Mean Difference (Final Values)|-0.98||||0.009|TWO_SIDED|95.0|-1.72|-0.24||Participants with relevant outcomes reported on at least one follow-up time point were included in the analyses. Adjustment was made for baseline score, age, duration of symptoms, interaction term between treatment and follow-up.|Mixed Models Analysis|||||-0.24|-1.72|0.009
72383657|NCT02038452|144275542|SUPERIORITY||Mean Difference (Final Values)|0.76||||0.058|TWO_SIDED|95.0|-0.02|1.54||Participants with relevant outcomes reported on at least one follow-up time point were included in the analyses. Adjustment was made for baseline score, age, duration of symptoms, interaction term between treatment and follow-up.|Mixed Models Analysis|||||1.54|-0.02|0.058
72383658|NCT02038452|144275543|SUPERIORITY||Mean Difference (Final Values)|0.03||||0.95|TWO_SIDED|95.0|-0.79|0.85||Participants with relevant outcomes reported on at least one follow-up time point were included in the analyses. Adjustment was made for baseline score, age, duration of symptoms, interaction term between treatment and follow-up.|Mixed Models Analysis|||||0.85|-0.79|0.95
72383659|NCT02038452|144275544|SUPERIORITY||Mean Difference (Final Values)|0.41||||0.35|TWO_SIDED|95.0|-0.45|1.26||Participants with relevant outcomes reported on at least one follow-up time point were included in the analyses. Adjustment was made for baseline score, age, duration of symptoms, interaction term between treatment and follow-up.|Mixed Models Analysis|||||1.26|-0.45|0.35
72435372|NCT00906698|144383703|SUPERIORITY_OR_OTHER||Ratio of adjusted gMean|75.58|||||TWO_SIDED|90.0|65.037|87.837|||ANOVA|||||87.837|65.037|
72435373|NCT00906698|144383704|SUPERIORITY_OR_OTHER||Ratio of adjusted gMean|132.8|||||TWO_SIDED|90.0|72.305|243.917|||ANOVA|||||243.917|72.305|
72435374|NCT00906698|144383705|SUPERIORITY_OR_OTHER||Ratio of adjusted gMean|83.8|||||TWO_SIDED|90.0|61.156|114.823|||ANOVA|||||114.823|61.156|
72435375|NCT00906698|144383708|SUPERIORITY_OR_OTHER||Ratio of adjusted gMean|90.21|||||TWO_SIDED|90.0|76.071|106.978|||ANOVA|||||106.978|76.071|
72618738|NCT01026038|144768109|SUPERIORITY_OR_OTHER||GMT ratio|0.9|||||TWO_SIDED|95.0|0.63|1.29||||||Serotype 23F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.29|0.63|
72383660|NCT02038452|144275545|SUPERIORITY||Mean Difference (Final Values)|-0.36|||<|0.001|TWO_SIDED|95.0|-0.54|-0.19|||Regression, Linear|Complete case analysis as a sensitivity analysis was performed. Linear regression adjusted for baseline score, sex, age, and duration of symptoms.||||-0.19|-0.54|<0.001
72383661|NCT02038452|144275546|SUPERIORITY||Mean Difference (Final Values)|-0.4|||<|0.001|TWO_SIDED|95.0|-0.59|-0.21|||Regression, Linear|Complete case analysis as a sensitivity analysis was performed. Linear regression adjusted for baseline score, sex, age, and duration of symptoms.||||-0.21|-0.59|<0.001
72383662|NCT02038452|144275547|SUPERIORITY||Mean Difference (Final Values)|-0.26||||0.005|TWO_SIDED|95.0|-0.44|-0.08|||Regression, Linear|Complete case analysis as a sensitivity analysis was performed. Linear regression adjusted for baseline score, sex, age, and duration of symptoms.||||-0.08|-0.44|0.005
72383663|NCT02038452|144275548|SUPERIORITY||Mean Difference (Final Values)|-1.05||||0.002|TWO_SIDED|95.0|-1.72|-0.38|||Regression, Linear|Complete case analysis as a sensitivity analysis was performed. Linear regression adjusted for baseline score, sex, age, and duration of symptoms.||||-0.38|-1.72|0.002
72383664|NCT02038452|144275549|SUPERIORITY||Odds Ratio (OR)|0.35||||0.006|TWO_SIDED|95.0|0.17|0.74|||Regression, Logistic|Complete case analysis as a sensitivity analysis was performed. Logistic regression adjusted for baseline score, sex, age, and duration of symptoms.||||0.74|0.17|0.006
72383665|NCT02038452|144275550|SUPERIORITY||Mean Difference (Final Values)|0.05||||0.58|TWO_SIDED|95.0|-0.13|0.24|||Regression, Linear|Complete case analysis as a sensitivity analysis was performed. Linear regression adjusted for baseline score, sex, age, and duration of symptoms.||||0.24|-0.13|0.58
72383666|NCT02038452|144275551|SUPERIORITY||Mean Difference (Final Values)|0.13||||0.25|TWO_SIDED|95.0|-0.09|0.35|||Regression, Linear|Complete case analysis as a sensitivity analysis was performed. Linear regression adjusted for baseline score, sex, age, and duration of symptoms.||||0.35|-0.09|0.25
72383667|NCT02038452|144275552|SUPERIORITY||Mean Difference (Final Values)|0.01||||0.93|TWO_SIDED|95.0|-0.17|0.18|||Regression, Linear|Complete case analysis as a sensitivity analysis was performed. Linear regression adjusted for baseline score, sex, age, and duration of symptoms.||||0.18|-0.17|0.93
72383668|NCT02038452|144275553|SUPERIORITY||Mean Difference (Final Values)|0.8||||0.052|TWO_SIDED|95.0|-0.01|1.61|||Regression, Linear|Complete case analysis as a sensitivity analysis was performed. Linear regression adjusted for baseline score, sex, age, and duration of symptoms.||||1.61|-0.01|0.052
72383669|NCT02038452|144275554|SUPERIORITY||Odds Ratio (OR)|1.29||||0.53|TWO_SIDED|95.0|0.58|2.88|||Regression, Logistic|Complete case analysis as a sensitivity analysis was performed. Logistic regression adjusted for baseline score, sex, age, and duration of symptoms.||||2.88|0.58|0.53
72383670|NCT02038452|144275555|SUPERIORITY||Odds Ratio (OR)|1.43||||0.41|TWO_SIDED|95.0|0.61|3.34|||Regression, Logistic|Complete case analysis as a sensitivity analysis was performed. Logistic regression adjusted for sex, age, and duration of symptoms.||||3.34|0.61|0.41
72383671|NCT02038452|144275557|SUPERIORITY||Odds Ratio (OR)|1.32||||0.52|TWO_SIDED|95.0|0.57|3.06|||Regression, Logistic|Complete case analysis as a sensitivity analysis was performed. Logistic regression adjusted for sex, age, and duration of symptoms.||||3.06|0.57|0.52
72383672|NCT02038452|144275558|SUPERIORITY||Odds Ratio (OR)|2.05||||0.18|TWO_SIDED|95.0|0.72|5.78|||Regression, Logistic|Complete case analysis as a sensitivity analysis was performed. Logistic regression adjusted for sex, age, and duration of symptoms.||||5.78|0.72|0.18
72383673|NCT02038452|144275559|SUPERIORITY||Mean Difference (Final Values)|-0.36|||<|0.001|TWO_SIDED|95.0|-0.55|-0.18|||Regression, Linear|Per protocol analysis on complete date was performed. Linear regression adjusted for baseline score, sex, age, and duration of symptoms.||||-0.18|-0.55|<0.001
72383674|NCT02038452|144275560|SUPERIORITY||Mean Difference (Final Values)|-0.39|||<|0.001|TWO_SIDED|95.0|-0.59|-0.19|||Regression, Linear|Per protocol analysis on complete date was performed. Linear regression adjusted for baseline score, sex, age, and duration of symptoms.||||-0.19|-0.59|<0.001
72383675|NCT02038452|144275561|SUPERIORITY||Mean Difference (Final Values)|-0.28||||0.003|TWO_SIDED|95.0|-0.46|-0.09|||Regression, Linear|Per protocol analysis on complete date was performed. Linear regression adjusted for baseline score, sex, age, and duration of symptoms.||||-0.09|-0.46|0.003
72383676|NCT02038452|144275562|SUPERIORITY||Mean Difference (Final Values)|-1.16||||0.001|TWO_SIDED|95.0|-1.85|-0.48|||Regression, Linear|Per protocol analysis on complete date was performed. Linear regression adjusted for baseline score, sex, age, and duration of symptoms.||||-0.48|-1.85|0.001
72383677|NCT02038452|144275563|SUPERIORITY||Odds Ratio (OR)|0.34||||0.007|TWO_SIDED|95.0|0.16|0.74|||Regression, Logistic|Per protocol analysis on complete date was performed. Logistic regression adjusted for baseline score, sex, age, and duration of symptoms.||||0.74|0.16|0.007
72383678|NCT02038452|144275564|SUPERIORITY||Mean Difference (Final Values)|0.05||||0.63|TWO_SIDED|95.0|-0.15|0.25|||Regression, Linear|Per protocol analysis on complete date was performed. Linear regression adjusted for baseline score, sex, age, and duration of symptoms.||||0.25|-0.15|0.63
72383679|NCT02038452|144275565|SUPERIORITY||Mean Difference (Final Values)|0.12||||0.28|TWO_SIDED|95.0|-0.1|0.35|||Regression, Linear|Per protocol analysis on complete date was performed. Linear regression adjusted for baseline score, sex, age, and duration of symptoms.||||0.35|-0.10|0.28
72383680|NCT02038452|144275566|SUPERIORITY||Mean Difference (Final Values)|0.01||||0.9|TWO_SIDED|95.0|-0.18|0.2|||Regression, Linear|Per protocol analysis on complete date was performed. Linear regression adjusted for baseline score, sex, age, and duration of symptoms.||||0.20|-0.18|0.900
72435376|NCT00906698|144383709|SUPERIORITY_OR_OTHER||Ratio of adjusted gMean|76.75|||||TWO_SIDED|90.0|56.71|103.871|||ANOVA|||||103.871|56.710|
72383681|NCT02038452|144275567|SUPERIORITY||Mean Difference (Final Values)|0.74||||0.09|TWO_SIDED|95.0|-0.11|1.59|||Regression, Linear|Per protocol analysis on complete date was performed. Linear regression adjusted for baseline score, sex, age, and duration of symptoms.||||1.59|-0.11|0.09
72435377|NCT00906698|144383710|SUPERIORITY_OR_OTHER||Ratio of adjusted gMean|83.86|||||TWO_SIDED|95.0|66.369|105.966|||ANOVA|||||105.966|66.369|
72435378|NCT00906698|144383711|SUPERIORITY_OR_OTHER||Ratio of adjusted gMean|81.7|||||TWO_SIDED|90.0|60.47|110.369|||ANOVA|||||110.369|60.470|
72435379|NCT03095508|144383714|SUPERIORITY|||||||0.446|||||||Fisher Exact|||||||0.446
72435380|NCT03095508|144383716|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.0
72435381|NCT03095508|144383717|SUPERIORITY|||||||0.145|||||||t-test, 2 sided|||||||0.145
72435382|NCT03095508|144383718|SUPERIORITY|||||||0.188|||||||Wilcoxon (Mann-Whitney)|||||||0.188
72558081|NCT03442322|144645672|OTHER|Given that we found baseline differences in resident characteristics and outcomes, we implemented a difference-in-differences model for all outcomes.|Difference-in-Difference estimator|-0.73||||0.765|TWO_SIDED||||||Regression, Linear|All regressions controlled for resident characteristics, nursing home staffing, resident COVID cases, and nursing home fixed effects.||||||0.765
72558082|NCT03442322|144645673|OTHER|Given that we found baseline differences in resident characteristics and outcomes, we implemented a difference-in-differences model for all outcomes.|Difference-in-Difference estimator|0.77||||0.808|TWO_SIDED||||||Regression, Linear|All regressions controlled for resident characteristics, nursing home staffing, resident COVID cases, and nursing home fixed effects.||||||0.808
72558083|NCT03442322|144645674|OTHER|Given that we found baseline differences in resident characteristics and outcomes, we implemented a difference-in-differences model for all outcomes.|Difference-in-Difference estimator|3.86||||0.108|TWO_SIDED||||||Regression, Linear|All regressions controlled for resident characteristics and nursing home fixed effects.||||||0.108
72558084|NCT03442322|144645675|OTHER|Given that we found baseline differences in resident characteristics and outcomes, we implemented a difference-in-differences model for all outcomes.|Difference-in-Difference estimator|2.59||||0.411|TWO_SIDED||||||Regression, Linear|All regressions controlled for resident characteristics, nursing home staffing, resident COVID cases, and nursing home fixed effects.||||||0.411
72558085|NCT03442322|144645676|OTHER|Given that we found baseline differences in resident characteristics and outcomes, we implemented a difference-in-differences model for all outcomes.|Difference-in-Difference estimator|-0.08||||0.981|TWO_SIDED||||||Regression, Linear|All regressions controlled for resident characteristics, nursing home staffing, resident COVID cases, and nursing home fixed effects.||||||0.981
72558086|NCT03442322|144645677|OTHER|Given that we found baseline differences in resident characteristics and outcomes, we implemented a difference-in-differences model for all outcomes.|Difference-in-Difference estimator|3.51||||0.02|TWO_SIDED||||||Regression, Linear|All regressions controlled for resident characteristics and nursing home fixed effects.||||||0.020
72383682|NCT02038452|144275568|SUPERIORITY||Odds Ratio (OR)|1.26||||0.58|TWO_SIDED|95.0|0.56|2.85|||Regression, Logistic|Per protocol analysis on complete date was performed. Logistic regression adjusted for baseline score, sex, age, and duration of symptoms.||||2.85|0.56|0.58
72383683|NCT02038452|144275569|SUPERIORITY||Odds Ratio (OR)|1.31||||0.52|TWO_SIDED|95.0|0.57|3.01|||Regression, Logistic|Per protocol analysis on complete date was performed. Logistic regression adjusted for sex, age, and duration of symptoms.||||3.01|0.57|0.52
72435383|NCT03095508|144383719|NON_INFERIORITY|non-inferiority margin 14.5% absolute difference between percentages in group A and B|Risk Difference (RD)|0.14||||1e-05|TWO_SIDED|95.0|0.03|0.24||p- value for superiority: 0.021|Fisher Exact|||p1=proportion of patients without sore throat at Day 4 in Arm A p2=proportion of patients without sore throat at Day 4 in Arm B Н0: p1 - p2 ≤ -0.145||0.24|0.03|0.00001
72435384|NCT01651949|144383754|NON_INFERIORITY_OR_EQUIVALENCE|Criterion for non-inferiority with respect to GMT ratio (heterosexual males / females) required that the lower bound of the 95% confidence interval was \>0.67, to exclude a decrease of 1.5-fold or more|GMT Ratio|1.11|||<|0.001|TWO_SIDED|95.0|1.02|1.21|||ANOVA|An analysis of variance model with a response of log individual titers and fixed effect for group was used.||Anti-HPV Type 6||1.21|1.02|<0.001
72435385|NCT01651949|144383754|NON_INFERIORITY_OR_EQUIVALENCE|Criterion for non-inferiority with respect to GMT ratio (heterosexual males / females) required that the lower bound of the 95% confidence interval was \>0.67, to exclude a decrease of 1.5-fold or more|GMT Ratio|1.09|||<|0.001|TWO_SIDED|95.0|1.0|1.19|||ANOVA|An analysis of variance model with a response of log individual titers and fixed effect for group was used||Anti-HPV Type 11||1.19|1.00|<0.001
72558087|NCT03442322|144645678|OTHER|Given that we found baseline differences in resident characteristics and outcomes, we implemented a difference-in-differences model for all outcomes.|Difference-in-Difference estimator|1.62||||0.299|TWO_SIDED||||||Regression, Linear|All regressions controlled for resident characteristics, nursing home staffing, resident COVID cases, and nursing home fixed effects.||||||0.299
72558088|NCT03442322|144645679|OTHER|Given that we found baseline differences in resident characteristics and outcomes, we implemented a difference-in-differences model for all outcomes.|Difference-in-Difference estimator|1.68||||0.389|TWO_SIDED||||||Regression, Linear|All regressions controlled for resident characteristics, nursing home staffing, resident COVID cases, and nursing home fixed effects.||||||0.389
72558089|NCT03442322|144645680|OTHER|Given that we found baseline differences in resident characteristics and outcomes, we implemented a difference-in-differences model for all outcomes.|Difference-in-Difference estimator|-2.14||||0.389|TWO_SIDED||||||Regression, Linear|All regressions controlled for resident characteristics and nursing home fixed effects.||||||0.389
72558090|NCT03442322|144645681|OTHER|Given that we found baseline differences in resident characteristics and outcomes, we implemented a difference-in-differences model for all outcomes.|Difference-in-Difference estimator|-5.95||||0.043|TWO_SIDED||||||Regression, Linear|All regressions controlled for resident characteristics, nursing home staffing, resident COVID cases, and nursing home fixed effects.||||||0.043
72558091|NCT03442322|144645682|OTHER|Given that we found baseline differences in resident characteristics and outcomes, we implemented a difference-in-differences model for all outcomes.|Difference-in-Difference estimator|-3.91||||0.279|TWO_SIDED||||||Regression, Linear|All regressions controlled for resident characteristics, nursing home staffing, resident COVID cases, and nursing home fixed effects.||||||0.279
72558092|NCT03442322|144645683|OTHER|Given that we found baseline differences in resident characteristics and outcomes, we implemented a difference-in-differences model for all outcomes.|Difference-in-Difference estimator|0.92||||0.728|TWO_SIDED||||||Regression, Linear|All regressions controlled for resident characteristics and nursing home fixed effects.||||||0.728
72558093|NCT03442322|144645684|OTHER|Given that we found baseline differences in resident characteristics and outcomes, we implemented a difference-in-differences model for all outcomes.|Difference-in-Difference estimator|-1.75||||0.49|TWO_SIDED||||||Regression, Linear|All regressions controlled for resident characteristics, nursing home staffing, resident COVID cases, and nursing home fixed effects.||||||0.490
72618739|NCT01026038|144768109|SUPERIORITY_OR_OTHER||GMT ratio|3.1|||||TWO_SIDED|95.0|2.4|4.06||||||Serotype 1: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||4.06|2.40|
72435386|NCT01651949|144383754|NON_INFERIORITY_OR_EQUIVALENCE|Criterion for non-inferiority with respect to GMT ratio (heterosexual males / females) required that the lower bound of the 95% confidence interval was \>0.67, to exclude a decrease of 1.5-fold or more|GMT Ratio|1.2|||<|0.001|TWO_SIDED|95.0|1.1|1.3|||ANOVA|An analysis of variance model with a response of log individual titers and fixed effect for group was used||Anti-HPV Type 16||1.30|1.10|<0.001
72435387|NCT01651949|144383754|NON_INFERIORITY_OR_EQUIVALENCE|Criterion for non-inferiority with respect to GMT ratio (heterosexual males / females) required that the lower bound of the 95% confidence interval was \>0.67, to exclude a decrease of 1.5-fold or more|GMT Ratio|1.19|||<|0.001|TWO_SIDED|95.0|1.08|1.31|||ANOVA|An analysis of variance model with a response of log individual titers and fixed effect for group was used||Anti-HPV Type 18||1.31|1.08|<0.001
72435388|NCT01651949|144383754|NON_INFERIORITY_OR_EQUIVALENCE|Criterion for non-inferiority with respect to GMT ratio (heterosexual males / females) required that the lower bound of the 95% confidence interval was \>0.67, to exclude a decrease of 1.5-fold or more|GMT Ratio|1.24|||<|0.001|TWO_SIDED|95.0|1.13|1.37|||ANOVA|An analysis of variance model with a response of log individual titers and fixed effect for group was used||Anti-HPV Type 31||1.37|1.13|<0.001
72435389|NCT01651949|144383754|NON_INFERIORITY_OR_EQUIVALENCE|Criterion for non-inferiority with respect to GMT ratio (heterosexual males / females) required that the lower bound of the 95% confidence interval was \>0.67, to exclude a decrease of 1.5-fold or more|GMT Ratio|1.19|||<|0.001|TWO_SIDED|95.0|1.1|1.3|||ANOVA|An analysis of variance model with a response of log individual titers and fixed effect for group was used||Anti-HPV Type 33||1.30|1.10|<0.001
72435390|NCT01651949|144383754|NON_INFERIORITY_OR_EQUIVALENCE|Criterion for non-inferiority with respect to GMT ratio (heterosexual males / females) required that the lower bound of the 95% confidence interval was \>0.67, to exclude a decrease of 1.5-fold or more|GMT Ratio|1.27|||<|0.001|TWO_SIDED|95.0|1.14|1.41|||ANOVA|An analysis of variance model with a response of log individual titers and fixed effect for group was used||Anti-HPV Type 45||1.41|1.14|<0.001
72435391|NCT01651949|144383754|NON_INFERIORITY_OR_EQUIVALENCE|Criterion for non-inferiority with respect to GMT ratio (heterosexual males / females) required that the lower bound of the 95% confidence interval was \>0.67, to exclude a decrease of 1.5-fold or more|GMT Ratio|1.15|||<|0.001|TWO_SIDED|95.0|1.05|1.26|||ANOVA|An analysis of variance model with a response of log individual titers and fixed effect for group was used||Anti-HPV Type 52||1.26|1.05|<0.001
72435392|NCT01651949|144383754|NON_INFERIORITY_OR_EQUIVALENCE|Criterion for non-inferiority with respect to GMT ratio (heterosexual males / females) required that the lower bound of the 95% confidence interval was \>0.67, to exclude a decrease of 1.5-fold or more|GMT Ratio|1.25|||<|0.001|TWO_SIDED|95.0|1.14|1.36|||ANOVA|An analysis of variance model with a response of log individual titers and fixed effect for group was used||Anti-HPV Type 58||1.36|1.14|<0.001
72435393|NCT01651949|144383755|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-11.5|||<|0.001|TWO_SIDED|95.0|-15.0|-8.0|||Miettinen & Nurminen||The incidence of AEs of injection-site erythema reported on the Vaccination Report Card was compared between heterosexual / MSM male participants and female participants|Injection-site Erythema||-8.0|-15.0|<0.001
72435394|NCT01651949|144383755|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-19.1|||<|0.001|TWO_SIDED|95.0|-22.5|-15.7|||Miettinen & Nurminen||The incidence of AEs of injection-site erythema reported on the Vaccination Report Card was compared between heterosexual / MSM male participants and female participants|Injection-site Pain||-15.7|-22.5|<0.001
72435395|NCT01651949|144383755|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-17.3|||<|0.001|TWO_SIDED|95.0|-20.8|-13.7|||Miettinen & Nurminen||The incidence of AEs of injection-site erythema reported on the Vaccination Report Card was compared between heterosexual / MSM male participants and female participants|Injection-site Swelling||-13.7|-20.8|<0.001
72435396|NCT01651949|144383756|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-1.5||||0.091|TWO_SIDED|95.0|-3.4|0.2|||Miettinen & Nurminen||The incidence of maximum body temperature \>=37.8° C reported on the Vaccination Report Card was compared between heterosexual / MSM male participants and female participants|Elevated Body Temperature||0.2|-3.4|0.091
72435397|NCT01651949|144383757|NON_INFERIORITY_OR_EQUIVALENCE|Criterion for non-inferiority with respect to seroconversion percentage (heterosexual males minus females) required that the lower bound of the 95% confidence interval was greater than -5|Risk Difference (RD)|0.1|||<|0.001|TWO_SIDED|95.0|-0.7|0.9|||Miettinen & Nurminen|||Anti-HPV Type 6||0.9|-0.7|<0.001
72435398|NCT01651949|144383757|NON_INFERIORITY_OR_EQUIVALENCE|Criterion for non-inferiority with respect to seroconversion percentage (heterosexual males minus females) required that the lower bound of the 95% confidence interval was greater than -5|Risk Difference (RD)|0.1|||<|0.001|TWO_SIDED|95.0|-0.3|0.8|||Miettinen & Nurminen|||Anti-HPV Type 11||0.8|-0.3|<0.001
72435399|NCT01651949|144383757|NON_INFERIORITY_OR_EQUIVALENCE|Criterion for non-inferiority with respect to seroconversion percentage (heterosexual males minus females) required that the lower bound of the 95% confidence interval was greater than -5|Risk Difference (RD)|0.1|||<|0.001|TWO_SIDED|95.0|-0.3|0.7|||Miettinen & Nurminen|||Anti-HPV Type 16||0.7|-0.3|<0.001
72435400|NCT01651949|144383757|NON_INFERIORITY_OR_EQUIVALENCE|Criterion for non-inferiority with respect to seroconversion percentage (heterosexual males minus females) required that the lower bound of the 95% confidence interval was greater than -5|Risk Difference (RD)|0.1|||<|0.001|TWO_SIDED|95.0|-0.4|0.8|||Miettinen & Nurminen|||Anti-HPV Type 18||0.8|-0.4|<0.001
72435401|NCT01651949|144383757|NON_INFERIORITY_OR_EQUIVALENCE|Criterion for non-inferiority with respect to seroconversion percentage (heterosexual males minus females) required that the lower bound of the 95% confidence interval was greater than -5|Risk Difference (RD)|0.0|||<|0.001|TWO_SIDED|95.0|-0.4|0.5|||Miettinen & Nurminen|||Anti-HPV Type 31||0.5|-0.4|<0.001
72494310|NCT04311086|144517485|OTHER|A propensity score will be estimated for each patient from a multivariable logistic regression model, which is the probability that the patient is in DYSTAL cohort. In this model, the DYSTAL cohort (binary variable) is the outcome variable, and the following covariates will be considered as independent variables for propensity score analysis model: baseline Office and 24-hour ABPM (continuous) SBP and DBP, age (continuous), gender (dichotomous), BMI (continuous), diabetes (dichotomous).|||||>|0.05|||||||ANCOVA|||Comparison to the SPYRAL HTN-OFF MED study (NCT02439749) using a propensity score stratification (sub classification) adjustment||||>0.05
72618740|NCT01026038|144768109|SUPERIORITY_OR_OTHER||GMT ratio|0.5|||||TWO_SIDED|95.0|0.39|0.66||||||Serotype 1: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||0.66|0.39|
72435402|NCT01651949|144383757|NON_INFERIORITY_OR_EQUIVALENCE|Criterion for non-inferiority with respect to seroconversion percentage (heterosexual males minus females) required that the lower bound of the 95% confidence interval was greater than -5|Risk Difference (RD)|0.1|||<|0.001|TWO_SIDED|95.0|-0.3|0.7|||Miettinen & Nurminen|||Anti-HPV Type 33||0.7|-0.3|<0.001
72435403|NCT01651949|144383757|NON_INFERIORITY_OR_EQUIVALENCE|Criterion for non-inferiority with respect to seroconversion percentage (heterosexual males minus females) required that the lower bound of the 95% confidence interval was greater than -5|Risk Difference (RD)|0.2|||<|0.001|TWO_SIDED|95.0|-0.4|1.0|||Miettinen & Nurminen|||Anti-HPV Type 45||1.0|-0.4|<0.001
72435404|NCT01651949|144383757|NON_INFERIORITY_OR_EQUIVALENCE|Criterion for non-inferiority with respect to seroconversion percentage (heterosexual males minus females) required that the lower bound of the 95% confidence interval was greater than -5|Risk Difference (RD)|0.2|||<|0.001|TWO_SIDED|95.0|-0.2|0.9|||Miettinen & Nurminen|||Anti-HPV Type 52||0.9|-0.2|<0.001
72435405|NCT01651949|144383757|NON_INFERIORITY_OR_EQUIVALENCE|Criterion for non-inferiority with respect to seroconversion percentage (heterosexual males minus females) required that the lower bound of the 95% confidence interval was greater than -5|Risk Difference (RD)|0.2|||<|0.001|TWO_SIDED|95.0|-0.2|0.9|||Miettinen & Nurminen|||Anti-HPV Type 58||0.9|-0.2|<0.001
72435406|NCT01806714|144383760|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.3|||<|0.04|TWO_SIDED|95.0|1.0|1.6|||clustered stratified Proportional Hazard||We determined hazard ratios using a clustered stratified Cox model with the Efron method to handle tied events and the Huber/White variance estimator that clustered on primary care provider and stratified on practice.|||1.6|1.0|<0.04
72435407|NCT01585038|144383763|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.54||||0.3|TWO_SIDED|95.0|-1.56|2.64|||t-test, 1 sided|||||2.64|-1.56|0.30
72435408|NCT01585038|144383764|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.21||||0.35|TWO_SIDED|95.0|-4.71|2.3|||t-test, 2 sided|||||2.30|-4.71|0.35
72435409|NCT01585038|144383765|SUPERIORITY_OR_OTHER||Mean Difference (Net)|6.7||||0.41|TWO_SIDED|95.0|-62.49|75.89|||t-test, 2 sided|||||75.89|-62.49|0.41
72435410|NCT01585038|144383766|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-194.1||||0.02|TWO_SIDED|95.0|-353.7|-34.6|||t-test, 2 sided|||||-34.6|-353.7|0.02
72435411|NCT01156116|144383804|SUPERIORITY_OR_OTHER|||||||0.03|TWO_SIDED||||||Mixed Models Analysis|Analyses were adjusted for age, body mass index, and ethnicity-based diabetes risk.||||||0.03
72435412|NCT01156116|144383805|SUPERIORITY_OR_OTHER|||||||0.04|TWO_SIDED||||||Mixed Models Analysis|Analyses were adjusted for age, body mass index, and ethnicity-based diabetes risk.||||||0.04
72435413|NCT01156116|144383806|SUPERIORITY_OR_OTHER|||||||0.009|TWO_SIDED||||||Mixed Models Analysis|Analyses were adjusted for age, body mass index, and ethnicity-based diabetes risk.||||||0.009
72435414|NCT01156116|144383807|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|Analyses were adjusted for age, body mass index, and ethnicity-based diabetes risk.||||||<0.001
72435415|NCT01245439|144383829|SUPERIORITY_OR_OTHER|||||||0.929|TWO_SIDED||||||Wilcoxon Signed Rank test.|||Change from Visit 1 to Visit 2||||0.929
72435416|NCT01245439|144383829|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Wilcoxon Signed Rank test.|||Change from Visit 2 to 3||||<0.001
72435417|NCT01245439|144383829|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Wilcoxon Signed Rank test.|||Change from Visit 3 to Visit 4||||<0.001
72435418|NCT01245439|144383829|SUPERIORITY_OR_OTHER|||||||0.05|TWO_SIDED||||||Wilcoxon Signed Rank test.|||Change from Visit 4 to Visit 5||||0.050
72435419|NCT01245439|144383829|SUPERIORITY_OR_OTHER|||||||0.165|TWO_SIDED||||||Wilcoxon Signed Rank test.|||Change from Visit 5 to Visit 6||||0.165
72435420|NCT01245439|144383829|SUPERIORITY_OR_OTHER|||||||0.133|TWO_SIDED||||||Wilcoxon Signed Rank test.|||Change from Visit 6 to Visit 7||||0.133
72435421|NCT01245439|144383829|SUPERIORITY_OR_OTHER|||||||0.217|TWO_SIDED||||||Wilcoxon Signed Rank test.|||Change from Visit 7 to Visit 8||||0.217
72435422|NCT01245439|144383829|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Wilcoxon Signed Rank test.|||Change from Visit 2 to Visit 8||||<0.001
72435423|NCT01245439|144383832|SUPERIORITY_OR_OTHER|||||||0.169|TWO_SIDED||||||Wilcoxon Signed Rank test.|||Change from Visit 1 to Visit 2||||0.169
72435424|NCT01245439|144383832|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Wilcoxon Signed Rank test.|||Change from Visit 2 to Visit 3||||<0.001
72435425|NCT01245439|144383832|SUPERIORITY_OR_OTHER|||||||0.053|TWO_SIDED||||||Wilcoxon Signed Rank test.|||Change from Visit 3 to Visit 4||||0.053
72435426|NCT01245439|144383832|SUPERIORITY_OR_OTHER|||||||0.514|TWO_SIDED||||||Wilcoxon Signed Rank test.|||Change from Visit 4 to Visit 5||||0.514
72435427|NCT01245439|144383832|SUPERIORITY_OR_OTHER|||||||0.064|TWO_SIDED||||||Wilcoxon Signed Rank test.|||Change from Visit 5 to Visit 6||||0.064
72435428|NCT01245439|144383832|SUPERIORITY_OR_OTHER|||||||0.038|TWO_SIDED||||||Wilcoxon Signed Rank test.|||Change from Visit 6 to Visit 7||||0.038
72435429|NCT01245439|144383832|SUPERIORITY_OR_OTHER|||||||0.064|TWO_SIDED||||||Wilcoxon Signed Rank test.|||Change from Visit 7 to Visit 8||||0.064
72435430|NCT01245439|144383832|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Wilcoxon Signed Rank test.|||Change from Visit 2 to Visit 8||||<0.001
72435431|NCT01245439|144383833|SUPERIORITY_OR_OTHER|||||||0.981|TWO_SIDED||||||Wilcoxon Signed Rank test.|||Change from Visit 1 to Visit 2||||0.981
72435432|NCT01245439|144383833|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Wilcoxon Signed Rank test.|||Change from Visit 2 to Visit 3||||<0.001
72435433|NCT01245439|144383833|SUPERIORITY_OR_OTHER|||||||0.005|TWO_SIDED||||||Wilcoxon Signed Rank test.|||Change from Visit 3 to Visit 4||||0.005
72435434|NCT01245439|144383833|SUPERIORITY_OR_OTHER|||||||0.566|TWO_SIDED||||||Wilcoxon Signed Rank test.|||Change from Visit 4 to Visit 5||||0.566
72435435|NCT01245439|144383833|SUPERIORITY_OR_OTHER|||||||0.264|TWO_SIDED||||||Wilcoxon Signed Rank test.|||Change from Visit 5 to Visit 6||||0.264
72435436|NCT01245439|144383833|SUPERIORITY_OR_OTHER|||||||0.126|TWO_SIDED||||||Wilcoxon Signed Rank test.|||Change from Visit 6 to Visit 7||||0.126
72435437|NCT01245439|144383833|SUPERIORITY_OR_OTHER|||||||0.779|TWO_SIDED||||||Wilcoxon Signed Rank test.|||Change from Visit 7 to Visit 8||||0.779
72435438|NCT01245439|144383833|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Wilcoxon Signed Rank test.|||||||<0.001
72435439|NCT01245439|144383834|SUPERIORITY_OR_OTHER|||||||0.41|TWO_SIDED||||||Wilcoxon Signed Rank test.|||Change in Sensitive Joints Visit 1 to Visit 2||||0.410
72435440|NCT01245439|144383834|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Wilcoxon Signed Rank test.|||Change in Sensitive Joints from Visit 2 to Visit 3||||<0.001
72558094|NCT03442322|144645685|OTHER|Given that we found baseline differences in resident characteristics and outcomes, we implemented a difference-in-differences model for all outcomes.|Difference-in-Difference estimator|4.44||||0.232|TWO_SIDED||||||Regression, Linear|All regressions controlled for resident characteristics, nursing home staffing, resident COVID cases, and nursing home fixed effects.||||||0.232
72558095|NCT03442322|144645686|OTHER|Given that we found baseline differences in resident characteristics and outcomes, we implemented a difference-in-differences model for all outcomes.|Difference-in-Difference estimator|1.11||||0.708|TWO_SIDED||||||Regression, Linear|All regressions controlled for resident characteristics and nursing home fixed effects.||||||0.708
72558096|NCT03442322|144645687|OTHER|Given that we found baseline differences in resident characteristics and outcomes, we implemented a difference-in-differences model for all outcomes.|Difference-in-Difference estimator|1.0||||0.775|TWO_SIDED||||||Regression, Linear|All regressions controlled for resident characteristics, nursing home staffing, resident COVID cases, and nursing home fixed effects.||||||0.775
72558097|NCT03442322|144645688|OTHER|Given that we found baseline differences in resident characteristics and outcomes, we implemented a difference-in-differences model for all outcomes.|Difference-in-Difference estimator|1.77||||0.584|TWO_SIDED||||||Regression, Linear|All regressions controlled for resident characteristics, nursing home staffing, resident COVID cases, and nursing home fixed effects.||||||0.584
72558098|NCT03442322|144645689|OTHER|Given that we found baseline differences in resident characteristics and outcomes, we implemented a difference-in-differences model for all outcomes.|Difference-in-Difference estimator|-0.25||||0.898|TWO_SIDED||||||Regression, Linear|All regressions controlled for resident characteristics and nursing home fixed effects.||||||0.898
72558099|NCT03442322|144645690|OTHER|Given that we found baseline differences in resident characteristics and outcomes, we implemented a difference-in-differences model for all outcomes.|Difference-in-Difference estimator|-2.79||||0.217|TWO_SIDED||||||Regression, Linear|All regressions controlled for resident characteristics, nursing home staffing, resident COVID cases, and nursing home fixed effects.||||||0.217
72558100|NCT03442322|144645691|OTHER|Given that we found baseline differences in resident characteristics and outcomes, we implemented a difference-in-differences model for all outcomes.|Difference-in-Difference estimator|-1.39||||0.56|TWO_SIDED||||||Regression, Linear|All regressions controlled for resident characteristics, nursing home staffing, resident COVID cases, and nursing home fixed effects.||||||0.560
72558101|NCT03442322|144645692|OTHER|Given that we found baseline differences in resident characteristics and outcomes, we implemented a difference-in-differences model for all outcomes.|Difference-in-Difference estimator|-3.08||||0.277|TWO_SIDED||||||Regression, Linear|All regressions controlled for resident characteristics and nursing home fixed effects.||||||0.277
72558102|NCT03442322|144645693|OTHER|Given that we found baseline differences in resident characteristics and outcomes, we implemented a difference-in-differences model for all outcomes.|Difference-in-Difference estimator|-2.53||||0.4|TWO_SIDED||||||Regression, Linear|All regressions controlled for resident characteristics, nursing home staffing, resident COVID cases, and nursing home fixed effects.||||||0.400
72558103|NCT03442322|144645694|OTHER|Given that we found baseline differences in resident characteristics and outcomes, we implemented a difference-in-differences model for all outcomes.|Difference-in-Difference estimator|-3.18||||0.303|TWO_SIDED||||||Regression, Linear|All regressions controlled for resident characteristics, nursing home staffing, resident COVID cases, and nursing home fixed effects.||||||0.303
72558104|NCT01404988|144645695|SUPERIORITY_OR_OTHER|||||||0.1|TWO_SIDED|||||For this pilot study, the Type 1 error was set at 5%|Wilcoxon (Mann-Whitney)|||||||0.1
72383684|NCT02038452|144275571|SUPERIORITY||Odds Ratio (OR)|1.25||||0.61|TWO_SIDED|95.0|0.53|2.95|||Regression, Logistic|Per protocol analysis on complete date was performed. Logistic regression adjusted for sex, age, and duration of symptoms.||||2.95|0.53|0.61
72383685|NCT02038452|144275572|SUPERIORITY||Odds Ratio (OR)|2.24||||0.14|TWO_SIDED|95.0|0.77|6.58|||Regression, Logistic|Per protocol analysis on complete date was performed. Logistic regression adjusted for sex, age, and duration of symptoms.||||6.58|0.77|0.14
72383686|NCT02038452|144275573|SUPERIORITY||Mean Difference (Final Values)|-0.52||||0.014|TWO_SIDED|95.0|-0.93|-0.12|||Regression, Linear|Sub group analysis on complete data was performed. Linear regression adjusted for baseline score, sex, age, and duration of symptoms.||||-0.12|-0.93|0.014
72383687|NCT02038452|144275574|SUPERIORITY||Mean Difference (Final Values)|-0.12||||0.53|TWO_SIDED|95.0|-0.5|0.26|||Regression, Linear|Sub group analysis on complete data was performed. Linear regression adjusted for baseline score, sex, age, and duration of symptoms.||||0.26|-0.50|0.53
72383688|NCT02038452|144275575|SUPERIORITY||Mean Difference (Final Values)|-0.24||||0.015|TWO_SIDED|95.0|-0.44|-0.05|||Regression, Linear|Sub group analysis on complete data was performed. Linear regression adjusted for baseline score, sex, age, and duration of symptoms.||||-0.05|-0.44|0.015
72383689|NCT02038452|144275576|SUPERIORITY||Mean Difference (Final Values)|-0.6||||0.002|TWO_SIDED|95.0|-0.97|-0.23|||Regression, Linear|Sub group analysis on complete data was performed. Linear regression adjusted for baseline score, sex, age, and duration of symptoms.||||-0.23|-0.97|0.002
72383690|NCT02038452|144275577|SUPERIORITY||Mean Difference (Final Values)|-0.22||||0.25|TWO_SIDED|95.0|-0.6|0.16|||Regression, Linear|Sub group analysis on complete data was performed. Linear regression adjusted for baseline score, sex, age, and duration of symptoms.||||0.16|-0.60|0.25
72435441|NCT01245439|144383834|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Wilcoxon Signed Rank test.|||Change in Sensitive Joints from Visit 3 to Visit 4||||<0.001
72558105|NCT01404988|144645695|SUPERIORITY_OR_OTHER|||||||0.2|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.2
72558106|NCT01404988|144645696|SUPERIORITY_OR_OTHER|||||||0.3|TWO_SIDED|||||For this pilot study, the type 1 error was set at 5%|Wilcoxon (Mann-Whitney)|||||||.3
72558107|NCT01404988|144645696|SUPERIORITY_OR_OTHER|||||||0.77|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.77
72558108|NCT01404988|144645697|SUPERIORITY_OR_OTHER|||||||0.03|TWO_SIDED|||||For this pilot study, the type 1 error was set at 5%|Wilcoxon (Mann-Whitney)|||||||0.03
72558109|NCT01404988|144645697|SUPERIORITY_OR_OTHER|||||||0.06|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.06
72558110|NCT01404988|144645698|SUPERIORITY_OR_OTHER|||||||0.6|TWO_SIDED|||||For this pilot study, type 1 error was set at 5%|Fisher Exact|||||||0.60
72558111|NCT01404988|144645698|SUPERIORITY_OR_OTHER|||||||0.16|TWO_SIDED||||||Fisher Exact|||||||0.16
72494311|NCT04311086|144517486|OTHER|A propensity score will be estimated for each patient from a multivariable logistic regression model, which is the probability that the patient is in DYSTAL cohort. In this model, the DYSTAL cohort (binary variable) is the outcome variable, and the following covariates will be considered as independent variables for propensity score analysis model: baseline Office and 24-hour ABPM (continuous) SBP and DBP, age (continuous), gender (dichotomous), BMI (continuous), diabetes (dichotomous).|||||>|0.05|||||||ANCOVA|||Comparison to the SPYRAL HTN-OFF MED study (NCT02439749) using a propensity score stratification (sub classification) adjustment.||||>0.05
72383691|NCT02038452|144275578|SUPERIORITY||Mean Difference (Final Values)|33.54|||||TWO_SIDED|95.0|-94.57|145.59|||Regression, Linear|Comparison of outcome between treatment groups performed on multiply imputed data||||145.59|-94.57|
72383692|NCT02038452|144275579|SUPERIORITY||Mean Difference (Final Values)|47.06|||||TWO_SIDED|95.0|-104.84|187.31|||Regression, Linear|Comparison of outcome between treatment groups on complete data.||||187.31|-104.84|
72383693|NCT02038452|144275580|SUPERIORITY||Mean Difference (Final Values)|113.15|||||TWO_SIDED|95.0|-37.09|279.21|||Regression, Linear|Comparison of outcome between treatment groups||||279.21|-37.09|
72383694|NCT02038452|144275581|SUPERIORITY||Mean Difference (Final Values)|71.1|||||TWO_SIDED|95.0|-120.84|291.24|||Regression, Linear|Comparison of outcome between treatment groups||||291.24|-120.84|
72383695|NCT02038452|144275582|SUPERIORITY||Mean Difference (Final Values)|0.008|||||TWO_SIDED|95.0|-0.01|0.02|||Regression, Linear|||||0.02|-0.01|
72383696|NCT02038452|144275583|SUPERIORITY||Mean Difference (Final Values)|-0.003|||||TWO_SIDED|95.0|-0.034|0.027|||Regression, Linear|||||0.027|-0.034|
72383697|NCT02038452|144275584|SUPERIORITY||Mean Difference (Final Values)|-0.022|||||TWO_SIDED|95.0|-0.093|0.045|||Regression, Linear|||||0.045|-0.093|
72383698|NCT01920555|144275704|SUPERIORITY||Mean Difference (Final Values)|-3.18||||0.14|TWO_SIDED|95.0|-5.93|-0.43||Holm's method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 0.1mg/kg vs. midazolam at Day 1:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY\*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm's method to protect family-wise error rate in the presence of multiple testing."||-0.43|-5.93|0.14
72383699|NCT01920555|144275704|SUPERIORITY||Mean Difference (Final Values)|-1.13||||0.79|TWO_SIDED|95.0|-3.75|1.49||Holm's method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 0.2mg/kg vs. midazolam at Day 1:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY\*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm's method to protect family-wise error rate in the presence of multiple testing."||1.49|-3.75|0.79
72383700|NCT01920555|144275704|SUPERIORITY||Mean Difference (Final Values)|-4.79|||<|0.01|TWO_SIDED|95.0|-7.35|-2.24||Holm's method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 0.5mg/kg vs. midazolam at Day 1:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY\*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm's method to protect family-wise error rate in the presence of multiple testing."||-2.24|-7.35|<0.01
72383701|NCT01920555|144275704|SUPERIORITY||Mean Difference (Final Values)|-3.76||||0.04|TWO_SIDED|95.0|-6.37|-1.15|||Mixed Models Analysis|||"Ketamine 1.0mg/kg vs. midazolam at Day 1:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY\*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm's method to protect family-wise error rate in the presence of multiple testing."||-1.15|-6.37|0.04
72383702|NCT01920555|144275704|SUPERIORITY||Mean Difference (Final Values)|-2.04||||0.72|TWO_SIDED|95.0|-5.04|0.95||Holm's method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 0.1mg/kg vs. midazolam at Day 3:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY\*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm's method to protect family-wise error rate in the presence of multiple testing."||0.95|-5.04|0.72
72383703|NCT01920555|144275704|SUPERIORITY||Mean Difference (Final Values)|-0.36||||0.8|TWO_SIDED|95.0|-3.18|2.46||Holm's method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 0.2mg/kg vs. midazolam at Day 3:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY\*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm's method to protect family-wise error rate in the presence of multiple testing."||2.46|-3.18|0.80
72383704|NCT01920555|144275704|SUPERIORITY||Mean Difference (Final Values)|-3.12||||0.14|TWO_SIDED|95.0|-5.97|-0.44||Holm's method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 0.5mg/kg vs. midazolam at Day 3:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY\*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm's method to protect family-wise error rate in the presence of multiple testing."||-0.44|-5.97|0.14
72383705|NCT01920555|144275704|SUPERIORITY||Mean Difference (Final Values)|-1.84||||0.72|TWO_SIDED|95.0|-4.65|0.96||Holm's method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 1.0mg/kg vs. midazolam at Day 3:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY\*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm's method to protect family-wise error rate in the presence of multiple testing."||0.96|-4.65|0.72
72494312|NCT04311086|144517490|OTHER|A propensity score will be estimated for each patient from a multivariable logistic regression model, which is the probability that the patient is in DYSTAL cohort. In this model, the DYSTAL cohort (binary variable) is the outcome variable, and the following covariates will be considered as independent variables for propensity score analysis model: baseline Office and 24-hour ABPM (continuous) SBP and DBP, age (continuous), gender (dichotomous), BMI (continuous), diabetes (dichotomous).|||||<|0.05|||||||ANCOVA|||Comparison to the SPYRAL HTN-OFF MED study (NCT02439749) using a propensity score stratification (sub classification) adjustment.||||<0.05
72494313|NCT04311086|144517491|OTHER|A propensity score will be estimated for each patient from a multivariable logistic regression model, which is the probability that the patient is in DYSTAL cohort. In this model, the DYSTAL cohort (binary variable) is the outcome variable, and the following covariates will be considered as independent variables for propensity score analysis model: baseline Office and 24-hour ABPM (continuous) SBP and DBP, age (continuous), gender (dichotomous), BMI (continuous), diabetes (dichotomous).|||||<|0.05|||||||ANCOVA|||||||<0.05
72494314|NCT04311086|144517492|OTHER|A propensity score will be estimated for each patient from a multivariable logistic regression model, which is the probability that the patient is in DYSTAL cohort. In this model, the DYSTAL cohort (binary variable) is the outcome variable, and the following covariates will be considered as independent variables for propensity score analysis model: baseline Office and 24-hour ABPM (continuous) SBP and DBP, age (continuous), gender (dichotomous), BMI (continuous), diabetes (dichotomous).|||||>|0.05|||||||ANCOVA|||Comparison to the SPYRAL HTN-OFF MED study (NCT02439749) using a propensity score stratification (sub classification) adjustment.||||>0.05
72494315|NCT04311086|144517493|OTHER|A propensity score will be estimated for each patient from a multivariable logistic regression model, which is the probability that the patient is in DYSTAL cohort. In this model, the DYSTAL cohort (binary variable) is the outcome variable, and the following covariates will be considered as independent variables for propensity score analysis model: baseline Office and 24-hour ABPM (continuous) SBP and DBP, age (continuous), gender (dichotomous), BMI (continuous), diabetes (dichotomous).|||||>|0.05|||||||ANCOVA|||Comparison to the SPYRAL HTN-OFF MED study (NCT02439749) using a propensity score stratification (sub classification) adjustment.||||>0.05
72494316|NCT02499029|144517577|SUPERIORITY|||||||0.05|||||||Regression, Linear|||A series of hierarchical linear regression analyses were conducted to examine the effects of treatment group (NAC or placebo) on PTSD symptomatology, craving, substance use, and depression. Baseline levels of the respective outcome measures were entered in Step 1 of the model to adjust for any baseline differences. Treatment group was entered as the predictor in Step 2. The significance threshold was set at a p-value of .05 (two-sided) for all statistical tests.||||.05
72494317|NCT03889639|144517591|SUPERIORITY|Relative reduction in lesions in SAR442168 5 mg (Cohorts 1 and 2) when compared with placebo (Cohort 2) with 95 percentage (%) confidence interval (CI) were reported. Analysis was performed using a negative binomial regression model adjusted for Baseline gadolinium-enhancing T1-hyperintense lesion activity (presence/absence).|Relative reduction in lesions|-56.16||||0.1673|TWO_SIDED|95.0|-193.99|17.05|||Negative binomial regression model|Threshold for significance for p-value was 0.05.||SAR442168 5 mg/Placebo||17.05|-193.99|0.1673
72494318|NCT03889639|144517591|SUPERIORITY|Relative reduction in lesions in SAR442168 15 mg (Cohorts 1 and 2) when compared with placebo (Cohort 2) with 95% CI were reported. Analysis was performed using a negative binomial regression model adjusted for Baseline gadolinium-enhancing T1-hyperintense lesion activity (presence/absence).|Relative reduction in lesions|-62.8||||0.354|TWO_SIDED|95.0|-356.24|41.91|||Negative binomial regression model|Threshold for significance for p-value was 0.05.||SAR442168 15 mg/Placebo||41.91|-356.24|0.3540
72494319|NCT03889639|144517591|SUPERIORITY|Relative reduction in lesions in SAR442168 30 mg (Cohorts 1 and 2) when compared with placebo (Cohort 2) with 95% CI were reported. Analysis was performed using a negative binomial regression model adjusted for Baseline gadolinium-enhancing T1-hyperintense lesion activity (presence/absence).|Relative reduction in lesions|13.49||||0.7674|TWO_SIDED|95.0|-126.05|66.89|||Negative binomial regression model|Threshold for significance for p-value was 0.05.||SAR442168 30 mg/Placebo||66.89|-126.05|0.7674
72494320|NCT03889639|144517591|SUPERIORITY|Relative reduction in lesions in SAR442168 60 mg (Cohorts 1 and 2) when compared with placebo (Cohort 2) with 95% CI were reported. Analysis was performed using a negative binomial regression model adjusted for Baseline gadolinium-enhancing T1-hyperintense lesion activity (presence/absence).|Relative reduction in lesions|85.02||||0.0178|TWO_SIDED|95.0|28.02|96.88|||Negative binomial regression model|Threshold for significance for p-value was 0.05.||SAR442168 60 mg/Placebo||96.88|28.02|0.0178
72494321|NCT03889639|144517592|SUPERIORITY|Relative reduction in lesions in SAR442168 5 mg (Cohorts 1 and 2) when compared with placebo (Cohort 2) with 95% CI were reported. Analysis was performed using a negative binomial regression model without adjusting for Baseline T2 lesion activity as all participants had at least one T2 lesion at Baseline.|Relative reduction in lesions|10.17||||0.7736|TWO_SIDED|95.0|-86.49|56.73|||Negative binomial regression model|Threshold for significance for p-value was 0.05.||SAR442168 5 mg/Placebo||56.73|-86.49|0.7736
72494322|NCT03889639|144517592|SUPERIORITY|Relative reduction in lesions in SAR442168 15 mg (Cohorts 1 and 2) when compared with placebo (Cohort 2) with 95% CI were reported. Analysis was performed using a negative binomial regression model without adjusting for Baseline T2 lesion activity as all participants had at least one T2 lesion at Baseline.|Relative reduction in lesions|37.07||||0.248|TWO_SIDED|95.0|-38.08|71.32|||Negative binomial regression model|Threshold for significance for p-value was 0.05.||SAR442168 15 mg/Placebo||71.32|-38.08|0.2480
72494323|NCT03889639|144517592|SUPERIORITY|Relative reduction in lesions in SAR442168 30 mg (Cohorts 1 and 2) when compared with placebo (Cohort 2) with 95% CI were reported. Analysis was performed using a negative binomial regression model without adjusting for Baseline T2 lesion activity as all participants had at least one T2 lesion at Baseline.|Relative reduction in lesions|38.5||||0.3081|TWO_SIDED|95.0|-56.61|75.85|||Negative binomial regression model|Threshold for significance for p-value was 0.05.||SAR442168 30 mg/Placebo||75.85|-56.61|0.3081
72494324|NCT03889639|144517592|SUPERIORITY|Relative reduction in lesions in SAR442168 60 mg (Cohorts 1 and 2) when compared with placebo (Cohort 2) with 95% CI were reported. Analysis was performed using a negative binomial regression model without adjusting for Baseline T2 lesion activity as all participants had at least one T2 lesion at Baseline.|Relative reduction in lesions|89.34||||0.0001|TWO_SIDED|95.0|68.39|96.41|||Negative binomial regression model|Threshold for significance for p-value was 0.05.||SAR442168 60 mg/Placebo||96.41|68.39|0.0001
72435442|NCT01245439|144383834|SUPERIORITY_OR_OTHER|||||||0.021|TWO_SIDED||||||Wilcoxon Signed Rank test.|||Change in Sensitive Joints from Visit 4 to Visit 5||||0.021
72435443|NCT01245439|144383834|SUPERIORITY_OR_OTHER|||||||0.003|TWO_SIDED||||||Wilcoxon Signed Rank test.|||Change in Sensitive Joints from Visit 5 to Visit 6||||0.003
72435444|NCT01245439|144383834|SUPERIORITY_OR_OTHER|||||||0.827|TWO_SIDED||||||Wilcoxon Signed Rank test.|||Change in Sensitive Joints from Visit 6 to Visit7||||0.827
72435445|NCT01245439|144383834|SUPERIORITY_OR_OTHER|||||||0.093|TWO_SIDED||||||Wilcoxon Signed Rank test.|||Change in Sensitive Joints from Visit 7 to Visit 8||||0.093
72435446|NCT01245439|144383834|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Wilcoxon Signed Rank test.|||Change in Sensitive Joints from Visit 2 to Visit 8||||<0.001
72435447|NCT01245439|144383834|SUPERIORITY_OR_OTHER|||||||0.792|TWO_SIDED||||||Wilcoxon Signed Rank test.|||Change in Swollen Joints from Visit 1 to Visit 2||||0.792
72435448|NCT01245439|144383834|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Wilcoxon Signed Rank test.|||Change in Swollen Joints from Visit 2 to Visit 3||||<0.001
72435449|NCT01245439|144383834|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED||||||Wilcoxon Signed Rank test.|||Change in Swollen Joints from Visit 3 to Visit 4||||0.002
72435450|NCT01245439|144383834|SUPERIORITY_OR_OTHER|||||||0.374|TWO_SIDED||||||Wilcoxon Signed Rank test.|||Change in Swollen Joints from Visit 4 to Visit 5||||0.374
72435451|NCT01245439|144383834|SUPERIORITY_OR_OTHER|||||||0.518|TWO_SIDED||||||Wilcoxon Signed Rank test.|||Change in Swollen Joints from Visit 5 to Visit 6||||0.518
72435452|NCT01245439|144383834|SUPERIORITY_OR_OTHER|||||||0.744|TWO_SIDED||||||Wilcoxon Signed Rank test.|||Change in Swollen Joints from Visit 6 to Visit 7||||0.744
72494325|NCT03889639|144517593|SUPERIORITY|Relative reduction in lesions in SAR442168 5 mg (Cohorts 1 and 2) when compared with placebo (Cohort 2) with 95% CI were reported. Analysis was performed using a negative binomial regression model adjusted for Baseline gadolinium-enhancing T1-hyperintense lesion activity (presence/absence).|Relative reduction in lesions|-62.16||||0.1525|TWO_SIDED|95.0|-214.44|16.38|||Negative binomial regression model|Threshold for significance for p-value was 0.05.||SAR442168 5 mg/Placebo||16.38|-214.44|0.1525
72494326|NCT03889639|144517593|SUPERIORITY|Relative reduction in lesions in SAR442168 15 mg (Cohorts 1 and 2) when compared with placebo (Cohort 2) with 95% CI were reported. Analysis was performed using a negative binomial regression model adjusted for Baseline gadolinium-enhancing T1-hyperintense lesion activity (presence/absence).|Relative reduction in lesions|-47.38||||0.4606|TWO_SIDED|95.0|-312.91|47.4|||Negative binomial regression model|Threshold for significance for p-value was 0.05.||SAR442168 15 mg/Placebo||47.40|-312.91|0.4606
72435453|NCT01245439|144383834|SUPERIORITY_OR_OTHER|||||||0.048|TWO_SIDED||||||Wilcoxon Signed Rank test.|||Change in Swollen Joints from Visit 7 to Visit 8||||0.048
72435454|NCT01245439|144383834|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Wilcoxon Signed Rank test.|||Change in Swollen Joints from Visit 2 to Visit 8||||<0.001
72435455|NCT01245439|144383835|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Wilcoxon Signed Rank test.|||PT assessment Visit 2 to Visit 3||||<0.001
72435456|NCT01245439|144383835|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Wilcoxon Signed Rank test.|||PT assessment Visit 3 to Visit 4||||<0.001
72435457|NCT01245439|144383835|SUPERIORITY_OR_OTHER|||||||0.075|TWO_SIDED||||||Wilcoxon Signed Rank test.|||PT assessment Visit 4 to Visit 5||||0.075
72435458|NCT01245439|144383835|SUPERIORITY_OR_OTHER|||||||0.119|TWO_SIDED||||||Wilcoxon Signed Rank test.|||PT assessment Visit 5 to Visit 6||||0.119
72435459|NCT01245439|144383835|SUPERIORITY_OR_OTHER|||||||0.007|TWO_SIDED||||||Wilcoxon Signed Rank test.|||PT assessment Visit 6 to Visit 7||||0.007
72435460|NCT01245439|144383835|SUPERIORITY_OR_OTHER|||||||0.047|TWO_SIDED||||||Wilcoxon Signed Rank test.|||PT assessment Visit 7 to Visit 8||||0.047
72435461|NCT01245439|144383835|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Wilcoxon Signed Rank test.|||PT assessment Visit 2 to Visit 8||||<0.001
72435462|NCT01245439|144383835|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Wilcoxon Signed Rank test.|||IN assessment Visit 2 to Visit 3||||<0.001
72435463|NCT01245439|144383835|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Wilcoxon Signed Rank test.|||IN assessment Visit 3 to Visit 4||||<0.001
72435464|NCT01245439|144383835|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED||||||Wilcoxon Signed Rank test.|||IN assessment Visit 4 to Visit 5||||0.001
72435465|NCT01245439|144383835|SUPERIORITY_OR_OTHER|||||||0.084|TWO_SIDED||||||Wilcoxon Signed Rank test.|||IN assessment Visit 5 to Visit 6||||0.084
72435466|NCT01245439|144383835|SUPERIORITY_OR_OTHER|||||||0.272|TWO_SIDED||||||Wilcoxon Signed Rank test.|||IN assessment Visit 6 to Visit 7||||0.272
72435467|NCT01245439|144383835|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED||||||Wilcoxon Signed Rank test.|||IN assessment Visit 7 to Visit 8||||0.020
72435468|NCT01245439|144383835|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Wilcoxon Signed Rank test.|||IN assessment Visit 2 to Visit 8||||<0.001
72435469|NCT01245439|144383836|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Wilcoxon Signed Rank test.|||Change between Visit 2 to Visit 3||||<0.001
72435470|NCT01245439|144383836|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Wilcoxon Signed Rank test.|||Change between Visit 3 to Visit 4||||<0.001
72435471|NCT01245439|144383836|SUPERIORITY_OR_OTHER|||||||0.254|TWO_SIDED||||||Wilcoxon Signed Rank test.|||Change between Visit 4 to Visit 5||||0.254
72435472|NCT01245439|144383836|SUPERIORITY_OR_OTHER|||||||0.138|TWO_SIDED||||||Wilcoxon Signed Rank test.|||Change between Visit 5 to Visit 6||||0.138
72435473|NCT01245439|144383836|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED||||||Wilcoxon Signed Rank test.|||Change between Visit 6 to Visit 7||||0.002
72435474|NCT01245439|144383836|SUPERIORITY_OR_OTHER|||||||0.104|TWO_SIDED||||||Wilcoxon Signed Rank test.|||Change between Visit 7 to Visit 8||||0.104
72435475|NCT01245439|144383836|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Wilcoxon Signed Rank test.|||Change between Visit 2 to Visit 8||||<0.001
72435476|NCT01245439|144383837|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Wilcoxon Signed Rank test.|||Change between Visit 2 to Visit 3||||<0.001
72435477|NCT01245439|144383837|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED||||||Wilcoxon Signed Rank test.|||Change between Visit 3 to Visit 4||||0.002
72435478|NCT01245439|144383837|SUPERIORITY_OR_OTHER|||||||0.078|TWO_SIDED||||||Wilcoxon Signed Rank test.|||Change between Visit 4 to Visit 5||||0.078
72435479|NCT01245439|144383837|SUPERIORITY_OR_OTHER|||||||0.349|TWO_SIDED||||||Wilcoxon Signed Rank test.|||Change between Visit 5 to Visit 6||||0.349
72383706|NCT01920555|144275705|SUPERIORITY||Mean Difference (Final Values)|-5.15||||0.33|TWO_SIDED|95.0|-12.44|2.14||Holm's method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 0.1 mg/kg vs. midazolam at Day 3:~As estimated by the repeated measures fixed effects model with DAY (0, 3), GROUP (5 groups as specified above), and the DAY\*GROUP interaction effect. Because there were four pairwise comparisons of interest (see Analysis 1-4), we used Holm's method to protect family-wise error rate in the presence of multiple testing."||2.14|-12.44|0.33
72383707|NCT01920555|144275705|SUPERIORITY||Mean Difference (Final Values)|-2.16||||0.53|TWO_SIDED|95.0|-9.03|4.72||Holm's method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 0.2 mg/kg vs. midazolam at Day 3:~As estimated by the repeated measures fixed effects model with DAY (0, 3), GROUP (5 groups as specified above), and the DAY\*GROUP interaction effect. Because there were four pairwise comparisons of interest (see Analysis 1-4), we used Holm's method to protect family-wise error rate in the presence of multiple testing."||4.72|-9.03|0.53
72494327|NCT03889639|144517593|SUPERIORITY|Relative reduction in lesions in SAR442168 30 mg (Cohorts 1 and 2) when compared with placebo (Cohort 2) with 95% CI were reported. Analysis was performed using a negative binomial regression model adjusted for Baseline gadolinium-enhancing T1-hyperintense lesion activity (presence/absence).|Relative reduction in lesions|2.9||||0.949|TWO_SIDED|95.0|-138.96|60.54|||Negative binomial regression model|Threshold for significance for p-value was 0.05.||SAR442168 30 mg/Placebo||60.54|-138.96|0.9490
72383708|NCT01920555|144275705|SUPERIORITY||Mean Difference (Final Values)|-9.85||||0.02|TWO_SIDED|95.0|-16.56|-3.15||Holm's method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 0.5 mg/kg vs. midazolam at Day 3:~As estimated by the repeated measures fixed effects model with DAY (0, 3), GROUP (5 groups as specified above), and the DAY\*GROUP interaction effect. Because there were four pairwise comparisons of interest (see Analysis 1-4), we used Holm's method to protect family-wise error rate in the presence of multiple testing."||-3.15|-16.56|0.02
72383709|NCT01920555|144275705|SUPERIORITY||Mean Difference (Final Values)|-7.72||||0.08|TWO_SIDED|95.0|-14.52|-0.93||Holm's method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 1.0 mg/kg vs. midazolam at Day 3:~As estimated by the repeated measures fixed effects model with DAY (0, 3), GROUP (5 groups as specified above), and the DAY\*GROUP interaction effect. Because there were four pairwise comparisons of interest (see Analysis 1-4), we used Holm's method to protect family-wise error rate in the presence of multiple testing."||-0.93|-14.52|0.08
72383710|NCT01920555|144275706|SUPERIORITY||Mean Difference (Final Values)|-1.03||||0.08|TWO_SIDED|95.0|-1.83|-0.22|||Mixed Models Analysis|||"Ketamine 0.1 mg/kg vs. midazolam at Day 1:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY\*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm's method to protect family-wise error rate in the presence of multiple testing."||-0.22|-1.83|0.08
72558112|NCT00829764|144645699|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model containing factors for sequence of products, subjects within sequence, periods, and products was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|93.52||||||90.0|88.49|98.83|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||98.83|88.49|
72383711|NCT01920555|144275706|SUPERIORITY||Mean Difference (Final Values)|-0.26||||0.82|TWO_SIDED|95.0|-1.02|0.51||Holm's method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 0.2 mg/kg vs. midazolam at Day 1:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY\*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm's method to protect family-wise error rate in the presence of multiple testing."||0.51|-1.02|0.82
72383712|NCT01920555|144275706|SUPERIORITY||Mean Difference (Final Values)|-1.28||||0.0072|TWO_SIDED|95.0|-2.02|-0.54||Holm's method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 0.5 mg/kg vs. midazolam at Day 1:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY\*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm's method to protect family-wise error rate in the presence of multiple testing."||-0.54|-2.02|0.00720
72383713|NCT01920555|144275706|SUPERIORITY||Mean Difference (Final Values)|-1.05||||0.04884|TWO_SIDED|95.0|-1.81|-0.29||Holm's method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 1.0 mg/kg vs. midazolam at Day 1:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY\*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm's method to protect family-wise error rate in the presence of multiple testing."||-0.29|-1.81|0.04884
72383714|NCT01920555|144275706|SUPERIORITY||Mean Difference (Final Values)|-0.71||||0.48|TWO_SIDED|95.0|-1.7|0.28||Holm's method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 0.1 mg/kg vs. midazolam at Day 3:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY\*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm's method to protect family-wise error rate in the presence of multiple testing."||0.28|-1.70|0.48
72383715|NCT01920555|144275706|SUPERIORITY||Mean Difference (Final Values)|-0.39||||0.82|TWO_SIDED|95.0|-1.32|0.55||Holm's method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 0.2 mg/kg vs. midazolam at Day 3:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY\*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm's method to protect family-wise error rate in the presence of multiple testing."||0.55|-1.32|0.82
72383716|NCT01920555|144275706|SUPERIORITY||Mean Difference (Final Values)|-1.0||||0.16|TWO_SIDED|95.0|-1.91|-0.09||Holm's method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 0.5 mg/kg vs. midazolam at Day 3:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY\*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm's method to protect family-wise error rate in the presence of multiple testing."||-0.09|-1.91|0.16
72383717|NCT01920555|144275706|SUPERIORITY||Mean Difference (Final Values)|-0.86||||0.27|TWO_SIDED|95.0|-1.78|0.07||Holm's method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 1.0 mg/kg vs. midazolam at Day 3:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY\*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm's method to protect family-wise error rate in the presence of multiple testing."||0.07|-1.78|0.27
72383718|NCT01920555|144275707|SUPERIORITY||Mean Difference (Net)|-0.54||||0.54|TWO_SIDED|95.0|-1.25|0.17||Holm's method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 0.1 mg/kg vs. midazolam at Day 1:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY\*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm's method to protect family-wise error rate in the presence of multiple testing."||0.17|-1.25|0.54
72383719|NCT01920555|144275707|SUPERIORITY||Mean Difference (Final Values)|-0.1||||1|TWO_SIDED|95.0|-0.78|0.58||Holm's method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 0.2 mg/kg vs. midazolam at Day 1:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY\*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm's method to protect family-wise error rate in the presence of multiple testing."||0.58|-0.78|1.00
72435480|NCT01245439|144383837|SUPERIORITY_OR_OTHER|||||||0.722|TWO_SIDED||||||Wilcoxon Signed Rank test.|||Change between Visit 6 to Visit 7||||0.722
72435481|NCT01245439|144383837|SUPERIORITY_OR_OTHER|||||||0.224|TWO_SIDED||||||Wilcoxon Signed Rank test.|||Change between Visit 7 to Visit 8||||0.224
72435482|NCT01227707|144383880|SUPERIORITY_OR_OTHER|||||||1|||||||one sample binomial test|||||||1.00
72435483|NCT01093534|144383909|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.169||||0.095|TWO_SIDED|95.0|-0.368|0.03||Hochberg Method for controlling the overall risk of type I error of 5% was used to adjust for using two co-primary endpoints.|ANCOVA|ANCOVA model with fixed effects for treatment and region and Baseline of least squares mean BWT as a covariate.||The null hypothesis was that the mean change from Baseline in BWT in the pooled solifenacin group and placebo was the same. Estimated as two-sided contrast with 95% confidence interval. Power was planned for 80% (assumption: mean difference = 0.5 mm, standard deviation=1.65, 314 and 157 participants, bonferroni adjustment for alpha =0.025)||0.030|-0.368|0.095
72435484|NCT01093534|144383910|SUPERIORITY_OR_OTHER_LEGACY|||||||0.25||||||Hochberg Method for controlling the overall risk of type I error of 5% was used to adjust for using two co-primary endpoints.|Wilcoxon (Mann-Whitney)|Nonparametric Wilcoxon rank-sum test does not adjust for other factors.||The null hypothesis for the co-primary treatment comparison was that the mean free (neutralized) uNGF/Cr value in the pooled solifenacin group and placebo was the same. Wilcoxon rank-sum test was used instead of a contrast from analysis of covariance (ANCOVA), because data was not normally distributed. Power was planned for 80% (assumption: mean difference = 0.74 pg/μmol, standard deviation=2.0, 220 and 110 participants, bonferroni adjustment for alpha =0.025).||||0.250
72435485|NCT03028363|144383934|OTHER|||||||0.343|||||||ANCOVA|Ranked ANCOVA, Markov Chain Monte Carlo (MCMC) Multiple Imputation||||||0.3430
72435486|NCT03028363|144383935|OTHER|||||||0.126|||||||ANCOVA|Ranked ANCOVA, Markov Chain Monte Carlo (MCMC) Multiple Imputation||||||0.1260
72435487|NCT03028363|144383936|OTHER|||||||0.5247|||||||Regression, Logistic|Logistic Regression (Firth's Penalized Likelihood), MCMC Multiple Imputation||||||0.5247
72435488|NCT00281918|144383937|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Log Rank|||||||<.0001
72435489|NCT00281918|144383938|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Log Rank|||||||<.0001
72435490|NCT00281918|144383939|SUPERIORITY_OR_OTHER|||||||0.0427||95.0|||||Log Rank|||||||0.0427
72435491|NCT00281918|144383940|SUPERIORITY_OR_OTHER|||||||0.7882||95.0|||||Log Rank|||||||0.7882
72435492|NCT00281918|144383941|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.57|||<|0.0001|TWO_SIDED|95.0|0.48|0.67|||Log Rank|||||0.67|0.48|<.0001
72435493|NCT00281918|144383942|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.68||||0.001|TWO_SIDED|95.0|0.54|0.86|||Log Rank|||||0.86|0.54|0.0010
72435494|NCT00281918|144383943|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.57|||<|0.0001||95.0|0.48|0.67|||Log Rank|||||0.67|0.48|<.0001
72435495|NCT00281918|144383944|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.73||||0.0523|TWO_SIDED|95.0|0.52|1.02|||Log Rank|||||1.02|0.52|0.0523
72435496|NCT00281918|144383945|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.58|||<|0.0001|TWO_SIDED|95.0|0.48|0.71|||Log Rank|||||0.71|0.48|<.0001
72435497|NCT00281918|144383946|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.3|||<|0.0001|TWO_SIDED|95.0|1.62|3.28|||Chi-squared|||||3.28|1.62|<.0001
72435498|NCT00281918|144383947|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.59|||<|0.0001|TWO_SIDED|95.0|0.49|0.72|||Log Rank|||||0.72|0.49|<.0001
72435499|NCT01199237|144383948|SUPERIORITY_OR_OTHER|||||||0.11||||||Significant at p\<0.05|Chi-squared|||||||0.11
72435500|NCT00605033|144383968|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was defined as a lower bound of the two-sided 95% confidence interval of the proportion difference greater than -0.15.|Proportion difference|-0.054|||||TWO_SIDED|95.0|-0.142|0.034|||Binomial approximation|||||0.034|-0.142|
72435501|NCT00954707|144384037|SUPERIORITY_OR_OTHER||Rate of TLF at 12-month (%)|6.4|||||TWO_SIDED|95.0|5.5|7.5||||||||7.5|5.5|
72435502|NCT00954707|144384038|SUPERIORITY_OR_OTHER||Rate of device success (%)|98.0|||||TWO_SIDED|95.0|97.4|98.4||||||||98.4|97.4|
72435503|NCT00954707|144384039|SUPERIORITY_OR_OTHER||Rate of lesion success (%)|99.8|||||TWO_SIDED|95.0|99.6|99.9||||||||99.9|99.6|
72435504|NCT00954707|144384040|SUPERIORITY_OR_OTHER||Rate of procedure success (%)|97.7|||||TWO_SIDED|95.0|97.0|98.2||||||||98.2|97.0|
72435505|NCT00954707|144384041|SUPERIORITY_OR_OTHER||Rate of Clinically-driven TLR (%)|4.2|||||TWO_SIDED|95.0|3.45|5.13||||||||5.13|3.45|
72435506|NCT00954707|144384042|SUPERIORITY_OR_OTHER||Rate of Clinically-driven TVR (%)|5.8|||||TWO_SIDED|95.0|4.87|6.81||||||||6.81|4.87|
72435507|NCT00954707|144384043|SUPERIORITY_OR_OTHER||Rate of Target vessel failure (%)|7.92|||||TWO_SIDED|95.0|6.85|9.09||||||||9.09|6.85|
72435508|NCT00954707|144384044|SUPERIORITY_OR_OTHER||Rate of MACE (%)|7.41|||||TWO_SIDED|95.0|6.37|8.55||||||||8.55|6.37|
72494328|NCT03889639|144517593|SUPERIORITY|Relative reduction in lesions in SAR442168 60 mg (Cohorts 1 and 2) when compared with placebo (Cohort 2) with 95% CI were reported. Analysis was performed using a negative binomial regression model adjusted for Baseline gadolinium-enhancing T1-hyperintense lesion activity (presence/absence).|Relative reduction in lesions|65.05||||0.2324|TWO_SIDED|95.0|-96.21|93.77|||Negative binomial regression model|Threshold for significance for p-value was 0.05.||SAR442168 60 mg/Placebo||93.77|-96.21|0.2324
72435509|NCT00954707|144384045|SUPERIORITY_OR_OTHER||Rate of protocol defined ST (%)|0.91|||||TWO_SIDED|95.0|0.56|1.38||||||||1.38|0.56|
72435510|NCT00954707|144384046|SUPERIORITY_OR_OTHER||Rate of ARC defined ST (%)|1.12|||||TWO_SIDED|95.0|0.74|1.64||||||||1.64|0.74|
72435511|NCT00954707|144384047|SUPERIORITY_OR_OTHER||Rate of major bleeding complications (%)|3.07|||||TWO_SIDED|95.0|2.4|3.85||||||||3.85|2.40|
72435512|NCT00954707|144384048|SUPERIORITY_OR_OTHER||Rate of cardiac death (%)|0.78|||||TWO_SIDED|95.0|0.46|1.23||||||||1.23|0.46|
72435513|NCT00954707|144384049|SUPERIORITY_OR_OTHER||Rate of non-cardiac death (%)|0.69|||||TWO_SIDED|95.0|0.4|1.12||||||||1.12|0.40|
72435514|NCT00309452|144384079|SUPERIORITY_OR_OTHER|||||||0.018|||||||Chi-squared, Corrected|||Between groups comparison for hospitalization rates, adjusted for pretreatment hospitalization||||0.018
72435515|NCT00309452|144384083|SUPERIORITY_OR_OTHER|||||||0.002|||||||Chi-squared, Corrected|||Between groups comparison for vocational engagement, adjusted for pretreatment vocational engagement||||0.002
72435516|NCT00771667|144384090|SUPERIORITY_OR_OTHER|||||||0.005||||||A fixed sequence testing procedure was employed to control the type I error rate at 0.05 level for the primary endpoint, beginning with the highest dose.|Cochran-Mantel-Haenszel|The CMH test is controlling for anti-TNF status.||||||0.005
72435517|NCT00771667|144384090|SUPERIORITY_OR_OTHER|||||||0.057||||||A fixed sequence testing procedure was employed to control the type I error rate at 0.05 level for the primary endpoint, beginning with the highest dose.|Cochran-Mantel-Haenszel|The CMH test is controlling for anti-TNF status.||||||0.057
72435518|NCT00771667|144384090|SUPERIORITY_OR_OTHER|||||||0.021||||||A fixed sequence testing procedure was employed to control the type I error rate at 0.05 level for the primary endpoint, beginning with the highest dose.|Cochran-Mantel-Haenszel|The CMH test is controlling for anti-TNF status.||||||0.021
72618741|NCT01026038|144768109|SUPERIORITY_OR_OTHER||GMT ratio|0.2|||||TWO_SIDED|95.0|0.12|0.22||||||Serotype 1: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||0.22|0.12|
72435519|NCT00771667|144384091|SUPERIORITY_OR_OTHER|||||||0.682|||||||Cochran-Mantel-Haenszel|The CMH test is controlling for anti-TNF status.||||||0.682
72435520|NCT00771667|144384091|SUPERIORITY_OR_OTHER|||||||0.206|||||||Cochran-Mantel-Haenszel|The CMH test is controlling for anti-TNF status.||||||0.206
72435521|NCT00771667|144384091|SUPERIORITY_OR_OTHER|||||||0.196|||||||Cochran-Mantel-Haenszel|The CMH test is controlling for anti-TNF status.||||||0.196
72435522|NCT00771667|144384092|SUPERIORITY_OR_OTHER|||||||0.008|||||||Cochran-Mantel-Haenszel|The CMH test is controlling for anti-TNF status.||||||0.008
72435523|NCT00771667|144384092|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|The CMH test is controlling for anti-TNF status.||||||<0.001
72435524|NCT00771667|144384092|SUPERIORITY_OR_OTHER|||||||0.035|||||||Cochran-Mantel-Haenszel|The CMH test is controlling for anti-TNF status.||||||0.035
72435525|NCT00771667|144384093|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|The CMH test is controlling for anti-TNF status.||||||<0.001
72435526|NCT00771667|144384093|SUPERIORITY_OR_OTHER|||||||0.007|||||||Cochran-Mantel-Haenszel|The CMH test is controlling for anti-TNF status.||||||0.007
72435527|NCT00771667|144384093|SUPERIORITY_OR_OTHER|||||||0.006|||||||Cochran-Mantel-Haenszel|The CMH test is controlling for anti-TNF status.||||||0.006
72435528|NCT00771667|144384094|SUPERIORITY_OR_OTHER|||||||0.074|||||||Cochran-Mantel-Haenszel|The CMH test is controlling for anti-TNF status.||||||0.074
72435529|NCT00771667|144384094|SUPERIORITY_OR_OTHER|||||||0.081|||||||Cochran-Mantel-Haenszel|The CMH test is controlling for anti-TNF status.||||||0.081
72435530|NCT00771667|144384094|SUPERIORITY_OR_OTHER|||||||0.105|||||||Cochran-Mantel-Haenszel|The CMH test is controlling for anti-TNF status.||||||0.105
72435531|NCT00771667|144384095|SUPERIORITY_OR_OTHER|||||||0.029||||||Testing for Week-22 clinical remission was performed if the comparison of 6-mg/kg ustekinumab with placebo was positive for the primary endpoint.|Cochran-Mantel-Haenszel|The CMH test chi-square test, stratified by IV induction dose and clinical remission status at Week 6.||||||0.029
72435532|NCT00771667|144384096|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|The CMH test is controlling for induction dose and clinical remission status at Week 6.||||||<0.001
72435533|NCT02715258|144384121|SUPERIORITY||mixed-effects repeated measures|-0.41||||0.0012|TWO_SIDED|95.0|-0.66|-0.16||The mixed-effects repeated measures analysis includes country, background anti-diabetes treatment status, treatment, visit, treatment-by-visit interaction and the baseline HbA1c value as a fixed effect covariate.|Mixed Models Analysis|||Analysis of change from baseline in HbA1c (%) at Week 24||-0.16|-0.66|0.0012
72435534|NCT02715258|144384121|SUPERIORITY||mixed-effects repeated measures|-0.41||||0.0021|TWO_SIDED|95.0|-0.68|-0.15||The mixed-effects repeated measures analysis includes country, background anti-diabetes treatment status, treatment, visit, treatment-by-visit interaction and the baseline HbA1c value as a fixed effect covariate.|ANCOVA|||Sensitivity Analysis 1: Multiple imputation for change from baseline in HbA1c (%) including observations obtained after rescue medication||-0.15|-0.68|0.0021
72435535|NCT02715258|144384121|SUPERIORITY||mixed-effects repeated measures|-0.55|||<|0.0001|TWO_SIDED|95.0|-0.8|-0.3||The mixed-effects repeated measures analysis includes country, background anti-diabetes treatment status, treatment, visit, treatment-by-visit interaction and the baseline HbA1c value as a fixed effect covariate.|Mixed Models Analysis|||Sensitivity Analysis 2: Multiple imputation for change from baseline in HbA1c (%) excluding observations obtained after rescue medication||-0.30|-0.80|<0.0001
72435536|NCT02715258|144384121|SUPERIORITY||mixed-effects repeated measures|-0.4||||0.0009|TWO_SIDED|95.0|-0.64|-0.17||The mixed-effects repeated measures analysis includes country, background anti-diabetes treatment status, treatment, visit, treatment-by-visit interaction and the baseline HbA1c value as a fixed effect covariate.|ANCOVA|||Sensitivity Analysis 3: LOCF for change from baseline in HbA1c (%) including observations obtained after rescue medication||-0.17|-0.64|0.0009
72435537|NCT02715258|144384122|SUPERIORITY||mixed-effects repeated measures|-2.14||||0.234|TWO_SIDED|95.0|-5.66|1.39||The mixed-effects repeated measures analysis includes country, background anti-diabetes treatment status, treatment, visit, treatment-by-visit interaction and the baseline HbA1c value as a fixed effect covariate.|ANCOVA|||Analysis of change from baseline in SBP (mm Hg) at Week 24||1.39|-5.66|0.2340
72435538|NCT02715258|144384122|SUPERIORITY||mixed-effects repeated measures|-1.91||||0.2937|TWO_SIDED|95.0|-5.48|1.66||The mixed-effects repeated measures analysis includes country, background anti-diabetes treatment status, treatment, visit, treatment-by-visit interaction and the baseline HbA1c value as a fixed effect covariate.|ANCOVA|||Sensitivity Analysis 1: Multiple imputation for change from baseline in SBP (mm Hg) including observations obtained after rescue medication||1.66|-5.48|0.2937
72435539|NCT02715258|144384122|SUPERIORITY||mixed-effects repeated measures|-1.72||||0.403|TWO_SIDED|95.0|-5.75|2.32||The mixed-effects repeated measures analysis includes country, background anti-diabetes treatment status, treatment, visit, treatment-by-visit interaction and the baseline HbA1c value as a fixed effect covariate.|ANCOVA|||Sensitivity Analysis 2: Multiple imputation for change from baseline in SBP (mm Hg) excluding observations obtained after rescue medication||2.32|-5.75|0.4030
72435540|NCT02715258|144384122|SUPERIORITY||mixed-effects repeated measures|-2.09||||0.216|TWO_SIDED|95.0|-5.41|1.23||The mixed-effects repeated measures analysis includes country, background anti-diabetes treatment status, treatment, visit, treatment-by-visit interaction and the baseline HbA1c value as a fixed effect covariate.|ANCOVA|||||1.23|-5.41|0.2160
72435541|NCT02715258|144384123|SUPERIORITY||mixed-effects repeated measures|-0.79||||0.1222|TWO_SIDED|95.0|-1.8|0.21||The mixed-effects repeated measures analysis includes country, background anti-diabetes treatment status, treatment, visit, treatment-by-visit interaction and the baseline HbA1c value as a fixed effect covariate.|ANCOVA|||Analysis of change from baseline in body weight (kg) at Week 24 for subjects with BMI greater than or equal to 25 kg/m2||0.21|-1.80|0.1222
72435542|NCT02715258|144384123|SUPERIORITY||mixed-effects repeated measures|-0.65||||0.2014|TWO_SIDED|95.0|-1.65|0.35||The mixed-effects repeated measures analysis includes country, background anti-diabetes treatment status, treatment, visit, treatment-by-visit interaction and the baseline HbA1c value as a fixed effect covariate.|ANCOVA|||Sensitivity Analysis 1: Multiple imputation for change from baseline in body weight (kg) for subjects with BMI greater than or equal to 25 kg/m2 including observations obtained after rescue medication||0.35|-1.65|0.2014
72435543|NCT02715258|144384123|SUPERIORITY||mixed-effects repeated measures|-0.91||||0.0638|TWO_SIDED|95.0|-1.88|0.05||The mixed-effects repeated measures analysis includes country, background anti-diabetes treatment status, treatment, visit, treatment-by-visit interaction and the baseline HbA1c value as a fixed effect covariate.|ANCOVA|||Sensitivity Analysis 2: Multiple imputation for change from baseline in body weight (kg) for subjects with BMI greater than or equal to 25 kg/m2 excluding observations obtained after rescue medication||0.05|-1.88|0.0638
72435544|NCT02715258|144384123|SUPERIORITY||mixed-effects repeated measures|-0.69||||0.1456|TWO_SIDED|95.0|-1.63|0.24||The mixed-effects repeated measures analysis includes country, background anti-diabetes treatment status, treatment, visit, treatment-by-visit interaction and the baseline HbA1c value as a fixed effect covariate.|ANCOVA|||Sensitivity Analysis 3: LOCF for change from baseline in body weight (kg) for subjects with BMI greater than or equal to 25 kg/m2 including observations obtained after rescue medication||0.24|-1.63|0.1456
72435545|NCT02715258|144384124|SUPERIORITY||mixed-effects repeated measures|-1.5|||<|0.0001|TWO_SIDED|95.0|-1.92|-1.09||The mixed-effects repeated measures analysis includes country, background anti-diabetes treatment status, treatment, visit, treatment-by-visit interaction and the baseline HbA1c value as a fixed effect covariate.|ANCOVA|||Analysis of change from baseline in FPG (mmol/L) over time across 24 weeks||-1.09|-1.92|<0.0001
72494329|NCT01703858|144517597|NON_INFERIORITY_OR_EQUIVALENCE|Assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMeans) with acceptance range of 80.00 to 125.00%|Ratio of Geometric means (%)|98.68|STANDARD_DEVIATION|10.0||0|TWO_SIDED|90.0|92.501|105.272|||ANOVA|Relative bioavailability was estimated by the ratios of the adjusted geometric means. CIs were calculated based on the residual error.|Analysis of variance includes the effects: sequence, subjects nested within sequences, period and treatment in crossover; subject and treatment in fixed sequence. Standard deviation is actually Intra individual geometric coefficient of variation.|B : BI-113608 vs. A : BI-113608 - Comparison with oral solution||105.272|92.501|0.0000
72618742|NCT01026038|144768109|SUPERIORITY_OR_OTHER||GMT ratio|1.4|||||TWO_SIDED|95.0|1.11|1.78||||||Serotype 3: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||1.78|1.11|
72435546|NCT02715258|144384125|SUPERIORITY||mixed-effects repeated measures|-0.61|||<|0.0001|TWO_SIDED|95.0|-0.79|-0.43||The mixed-effects repeated measures analysis includes country, background anti-diabetes treatment status, treatment, visit, treatment-by-visit interaction and the baseline HbA1c value as a fixed effect covariate.|ANCOVA|||Change from baseline in HbA1c (%) at Week 6||-0.43|-0.79|<0.0001
72383720|NCT01920555|144275707|SUPERIORITY||Mean Difference (Final Values)|-0.98||||0.03|TWO_SIDED|95.0|-1.64|-0.31||Holm's method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 0.5 mg/kg vs. midazolam at Day 1:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY\*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm's method to protect family-wise error rate in the presence of multiple testing."||-0.31|-1.64|0.03
72383721|NCT01920555|144275707|SUPERIORITY||Mean Difference (Final Values)|-0.56||||0.54|TWO_SIDED|95.0|-1.24|0.11||Holm's method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 1.0 mg/kg vs. midazolam at Day 1:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY\*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm's method to protect family-wise error rate in the presence of multiple testing."||0.11|-1.24|0.54
72383722|NCT01920555|144275707|SUPERIORITY||Mean Difference (Final Values)|-0.19||||1|TWO_SIDED|95.0|-0.96|0.57||Holm's method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 0.1 mg/kg vs. midazolam at Day 3:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY\*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm's method to protect family-wise error rate in the presence of multiple testing."||0.57|-0.96|1.00
72383723|NCT01920555|144275707|SUPERIORITY||Mean Difference (Final Values)|-0.21||||1|TWO_SIDED|95.0|-0.93|0.51||Holm's method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 0.2 mg/kg vs. midazolam at Day 3:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY\*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm's method to protect family-wise error rate in the presence of multiple testing."||0.51|-0.93|1.00
72383724|NCT01920555|144275707|SUPERIORITY||Mean Difference (Final Values)|-0.64||||0.52|TWO_SIDED|95.0|-1.35|0.06||Holm's method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 0.5 mg/kg vs. midazolam at Day 3:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY\*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm's method to protect family-wise error rate in the presence of multiple testing."||0.06|-1.35|0.52
72383725|NCT01920555|144275707|SUPERIORITY||Mean Difference (Final Values)|-0.62||||0.54|TWO_SIDED|95.0|-1.33|0.1||Holm's method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 1.0 mg/kg vs. midazolam at Day 3:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY\*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm's method to protect family-wise error rate in the presence of multiple testing."||0.10|-1.33|0.54
72383726|NCT01920555|144275708|SUPERIORITY||Mean Difference (Final Values)|-0.35||||0.74|TWO_SIDED|95.0|-0.79|0.08||Holm's method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 0.1 mg/kg vs. midazolam at Day 1:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY\*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm's method to protect family-wise error rate in the presence of multiple testing."||0.08|-0.79|0.74
72494330|NCT01703858|144517597|NON_INFERIORITY_OR_EQUIVALENCE|Assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMeans) with acceptance range of 80.00 to 125.00%|Ratio of Geometric means (%)|70.16|STANDARD_DEVIATION|18.3||0.9644|TWO_SIDED|90.0|62.331|78.962|||ANOVA|Relative bioavailability was estimated by the ratios of the adjusted geometric means. CIs were calculated based on the residual error.|Analysis of variance includes the effects: sequence, subjects nested within sequences, period and treatment in crossover; subject and treatment in fixed sequence. Standard deviation is actually Intra individual geometric coefficient of variation.|C : BI-113608 vs. B : BI-113608 - Food effect||78.962|62.331|0.9644
72494331|NCT01703858|144517597|NON_INFERIORITY_OR_EQUIVALENCE|Assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMeans) with acceptance range of 80.00 to 125.00%|Ratio of Geometric means (%)|83.36|STANDARD_DEVIATION|18.8||0.2835|TWO_SIDED|90.0|73.648|94.346|||ANOVA|Relative bioavailability was estimated by the ratios of the adjusted geometric means. CIs were calculated based on the residual error.|Analysis of variance includes the effects: sequence, subjects nested within sequences, period and treatment in crossover; subject and treatment in fixed sequence. Standard deviation is actually Intra individual geometric coefficient of variation.|E : BI-113608 vs. B : BI-113608 - Food effect||94.346|73.648|0.2835
72494332|NCT01703858|144517597|NON_INFERIORITY_OR_EQUIVALENCE|Assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMeans) with acceptance range of 80.00 to 125.00%|Ratio of Geometric means (%)|117.18|STANDARD_DEVIATION|16.7||0.1599|TWO_SIDED|90.0|104.923|130.867|||ANOVA|Relative bioavailability was estimated by the ratios of the adjusted geometric means. CIs were calculated based on the residual error.|Analysis of variance includes the effects: sequence, subjects nested within sequences, period and treatment in crossover; subject and treatment in fixed sequence. Standard deviation is actually Intra individual geometric coefficient of variation.|E : BI-113608 vs. C : BI-113608 - Food effect||130.867|104.923|0.1599
72383727|NCT01920555|144275708|SUPERIORITY||Mean Difference (Final Values)|0.04||||1|TWO_SIDED|95.0|-0.37|0.45||Holm's method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 0.2 mg/kg vs. midazolam at Day 1:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY\*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm's method to protect family-wise error rate in the presence of multiple testing."||0.45|-0.37|1.00
72383728|NCT01920555|144275708|SUPERIORITY||Mean Difference (Final Values)|-0.61||||0.02|TWO_SIDED|95.0|-1.01|-0.21||Holm's method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 0.5 mg/kg vs. midazolam at Day 1:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY\*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm's method to protect family-wise error rate in the presence of multiple testing."||-0.21|-1.01|0.02
72383729|NCT01920555|144275708|SUPERIORITY||Mean Difference (Final Values)|-0.31||||0.8|TWO_SIDED|95.0|-0.72|0.1||Holm's method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 1.0 mg/kg vs. midazolam at Day 1:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY\*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm's method to protect family-wise error rate in the presence of multiple testing."||0.10|-0.72|0.80
72383730|NCT01920555|144275708|SUPERIORITY||Mean Difference (Final Values)|-0.33||||0.88|TWO_SIDED|95.0|-0.83|0.18||Holm's method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 0.1 mg/kg vs. midazolam at Day 3:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY\*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm's method to protect family-wise error rate in the presence of multiple testing."||0.18|-0.83|0.88
72383731|NCT01920555|144275708|SUPERIORITY||Mean Difference (Final Values)|-0.05||||1|TWO_SIDED|95.0|-0.53|0.44||Holm's method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 0.2 mg/kg vs. midazolam at Day 3:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY\*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm's method to protect family-wise error rate in the presence of multiple testing."||0.44|-0.53|1.00
72383732|NCT01920555|144275708|SUPERIORITY||Mean Difference (Final Values)|-0.32||||0.88|TWO_SIDED|95.0|-0.79|0.15||Holm's method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 0.5 mg/kg vs. midazolam at Day 3:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY\*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm's method to protect family-wise error rate in the presence of multiple testing."||0.15|-0.79|0.88
72383733|NCT01920555|144275708|SUPERIORITY||Mean Difference (Final Values)|-0.29||||0.88|TWO_SIDED|95.0|-0.76|0.19||Holm's method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 1.0 mg/kg vs. midazolam at Day 3:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY\*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm's method to protect family-wise error rate in the presence of multiple testing."||0.19|-0.76|0.88
72383734|NCT01920555|144275709|SUPERIORITY||Mean Difference (Final Values)|11.18||||0.49|TWO_SIDED|95.0|-0.94|23.29||Holm's method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 0.1 mg/kg vs. midazolam at Day 1:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY\*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm's method to protect family-wise error rate in the presence of multiple testing."||23.29|-0.94|0.49
72435547|NCT02715258|144384125|SUPERIORITY||mixed-effects repeated measures|-0.71|||<|0.0001|TWO_SIDED|95.0|-0.92|-0.5||The mixed-effects repeated measures analysis includes country, background anti-diabetes treatment status, treatment, visit, treatment-by-visit interaction and the baseline HbA1c value as a fixed effect covariate.|ANCOVA|||Change from baseline in HbA1c (%) at Week 12||-0.50|-0.92|<0.0001
72435548|NCT02715258|144384125|SUPERIORITY||mixed-effects repeated measures|-0.57|||<|0.0001|TWO_SIDED|95.0|-0.78|-0.36||The mixed-effects repeated measures analysis includes country, background anti-diabetes treatment status, treatment, visit, treatment-by-visit interaction and the baseline HbA1c value as a fixed effect covariate.|ANCOVA|||Change from baseline in HbA1c (%) at Week 18||-0.36|-0.78|<0.0001
72558113|NCT00829764|144645700|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model containing factors for sequence of products, subjects within sequence, periods, and products was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|97.75||||||90.0|93.98|101.67|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||101.67|93.98|
72558114|NCT00829764|144645701|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model containing factors for sequence of products, subjects within sequence, periods, and products was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|98.46||||||90.0|94.78|102.28|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||102.28|94.78|
72558115|NCT02997176|144645739|OTHER|Bioequivalence|Percent Ratio of Geometric Means|142.19|||||TWO_SIDED|90.0|79.92|252.98||||||AUC0-24 was natural log-transformed and analyzed using an analysis of variance (ANOVA) model with hepatic function group as a fixed effect.||252.98|79.92|
72558116|NCT02997176|144645739|OTHER|Bioequivalence|Percent Ratio of Geometric Means|110.54|||||TWO_SIDED|90.0|54.58|223.85||||||AUC0-24 was natural log-transformed and analyzed using an analysis of variance (ANOVA) model with hepatic function group as a fixed effect.||223.85|54.58|
72558117|NCT02997176|144645740|OTHER|Bioequivalence|Percent Ratio of Geometric Means|109.76|||||TWO_SIDED|90.0|70.93|169.84||||||Cmax was natural log-transformed and analyzed using an ANOVA model with hepatic function group as a fixed effect.||169.84|70.93|
72558118|NCT02997176|144645740|OTHER|Bioequivalence|Percent Ratio of Geometric Means|131.67|||||TWO_SIDED|90.0|77.14|224.74||||||Cmax was natural log-transformed and analyzed using an ANOVA model with hepatic function group as a fixed effect.||224.74|77.14|
72618743|NCT01026038|144768109|SUPERIORITY_OR_OTHER||GMT ratio|0.8|||||TWO_SIDED|95.0|0.66|1.06||||||Serotype 3: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.06|0.66|
72383735|NCT01920555|144275709|SUPERIORITY||Mean Difference (Final Values)|1.37||||1|TWO_SIDED|95.0|-10.19|12.93||Holm's method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 0.2 mg/kg vs. midazolam at Day 1:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY\*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm's method to protect family-wise error rate in the presence of multiple testing."||12.93|-10.19|1.00
72383736|NCT01920555|144275709|SUPERIORITY||Mean Difference (Final Values)|16.54||||0.03|TWO_SIDED|95.0|5.31|27.77||Holm's method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 0.5 mg/kg vs. midazolam at Day 1:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY\*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm's method to protect family-wise error rate in the presence of multiple testing."||27.77|5.31|0.03
72383737|NCT01920555|144275709|SUPERIORITY||Mean Difference (Final Values)|8.68||||0.82|TWO_SIDED|95.0|-2.81|20.16||Holm's method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 1.0 mg/kg vs. midazolam at Day 1:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY\*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm's method to protect family-wise error rate in the presence of multiple testing."||20.16|-2.81|0.82
72383738|NCT01920555|144275709|SUPERIORITY||Mean Difference (Final Values)|5.11||||1|TWO_SIDED|95.0|-8.83|19.05||Holm's method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 0.1 mg/kg vs. midazolam at Day 3:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY\*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm's method to protect family-wise error rate in the presence of multiple testing."||19.05|-8.83|1.00
72383739|NCT01920555|144275709|SUPERIORITY||Mean Difference (Final Values)|-6.64||||1|TWO_SIDED|95.0|-19.87|6.59||Holm's method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 0.2 mg/kg vs. midazolam at Day 3:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY\*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm's method to protect family-wise error rate in the presence of multiple testing."||6.59|-19.87|1.00
72435549|NCT02715258|144384125|SUPERIORITY||mixed-effects repeated measures|-0.41||||0.0012|TWO_SIDED|95.0|-0.66|-0.16||The mixed-effects repeated measures analysis includes country, background anti-diabetes treatment status, treatment, visit, treatment-by-visit interaction and the baseline HbA1c value as a fixed effect covariate.|ANCOVA|||Change from baseline in HbA1c (%) at Week 24||-0.16|-0.66|0.0012
72435550|NCT02715258|144384125|SUPERIORITY||mixed-effects repeated measures|-0.58|||<|0.0001|TWO_SIDED|95.0|-0.76|-0.39||The mixed-effects repeated measures analysis includes country, background anti-diabetes treatment status, treatment, visit, treatment-by-visit interaction and the baseline HbA1c value as a fixed effect covariate.|ANCOVA|||Change from baseline in HbA1c (%) across 24 weeks||-0.39|-0.76|<0.0001
72558119|NCT02997176|144645741|OTHER|Bioequivalence|Percent Ratio of Geometric Means|149.39|||||TWO_SIDED|90.0|91.49|243.93||||||AUC0-24u was natural log-transformed and analyzed using an ANOVA model with hepatic function group as a fixed effect.||243.93|91.49|
72494333|NCT01703858|144517597|NON_INFERIORITY_OR_EQUIVALENCE|Assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMeans) with acceptance range of 80.00 to 125.00%|Ratio of Geometric means (%)|97.4|STANDARD_DEVIATION|15.8||0.002|TWO_SIDED|90.0|88.072|107.719|||ANOVA|Relative bioavailability was estimated by the ratios of the adjusted geometric means. CIs were calculated based on the residual error.|Analysis of variance includes the effects: sequence, subjects nested within sequences, period and treatment in crossover; subject and treatment in fixed sequence. Standard deviation is actually Intra individual geometric coefficient of variation.|D : BI-113608 vs. B : BI-113608 - Pantoprazole effect||107.719|88.072|0.0020
72558120|NCT02997176|144645741|OTHER|Bioequivalence|Percent Ratio of Geometric Means|111.04|||||TWO_SIDED|90.0|60.91|202.43||||||AUC0-24u was natural log-transformed and analyzed using an ANOVA model with hepatic function group as a fixed effect.||202.43|60.91|
72383740|NCT01920555|144275709|SUPERIORITY||Mean Difference (Final Values)|7.64||||1|TWO_SIDED|95.0|-5.26|20.53||Holm's method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 0.5 mg/kg vs. midazolam at Day 3:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY\*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm's method to protect family-wise error rate in the presence of multiple testing."||20.53|-5.26|1.00
72435551|NCT02715258|144384126|SUPERIORITY||Odds Ratio (OR)|3.39||||0.0006|TWO_SIDED|95.0|1.69|6.8||The logistic regression includes country, background anti-diabetes treatment status, treatment, visit, treatment-by-visit interaction and the baseline HbA1c value as a fixed effect covariate.|ANCOVA|||Model-Adjusted proportion of subjects with HbA1c \<7% across 24 weeks||6.80|1.69|0.0006
72435552|NCT02814643|144384127|OTHER||Geometric least-square mean ratio|0.87|||||TWO_SIDED|90.0|0.56|1.35|||ANCOVA|The linear model effects are treatment group as a fixed effect and age group (adolescents and young adults) as fixed categorical covariate.||Influenza A H1N1||1.35|0.56|
72435553|NCT02814643|144384127|OTHER||Geometric least-square mean ratio|1.19|||||TWO_SIDED|90.0|0.82|1.71|||ANCOVA|The linear model effects are treatment group as a fixed effect and age group (adolescents and young adults) as fixed categorical covariate.||Influenza A H3N2||1.71|0.82|
72435554|NCT02814643|144384127|OTHER||Geometric least-square mean ratio|0.93|||||TWO_SIDED|90.0|0.67|1.29|||ANCOVA|The linear model effects are treatment group as a fixed effect and age group (adolescents and young adults) as fixed categorical covariate.||Influenza B Yamagata lineage||1.29|0.67|
72435555|NCT02814643|144384127|OTHER||Geometric least-square mean ratio|0.8|||||TWO_SIDED|90.0|0.54|1.19|||ANCOVA|The linear model effects are treatment group as a fixed effect and age group (adolescents and young adults) as fixed categorical covariate.||Influenza B Victoria lineage||1.19|0.54|
72435556|NCT02814643|144384128|OTHER||Geometric least-square mean ratio|1.0|||||TWO_SIDED|90.0|0.76|1.31|||ANCOVA|The linear model effects are treatment group as a fixed effect and age group (adolescents and young adults) as fixed categorical covariate.||Influenza A H1N1||1.31|0.76|
72435557|NCT02814643|144384128|OTHER||Geometric least-square mean ratio|1.28|||||TWO_SIDED|90.0|0.93|1.77|||ANCOVA|The linear model effects are treatment group as a fixed effect and age group (adolescents and young adults) as fixed categorical covariate.||Influenza A H3N2||1.77|0.93|
72435558|NCT02814643|144384128|OTHER||Geometric least-square mean ratio|1.03||||||90.0|0.79|1.34|||ANCOVA|The linear model effects are treatment group as a fixed effect and age group (adolescents and young adults) as fixed categorical covariate.||Influenza B Yamagata lineage||1.34|0.79|
72435559|NCT02814643|144384128|OTHER||Geometric least-square mean ratio|1.26||||||90.0|0.93|1.7|||ANCOVA|The linear model effects are treatment group as a fixed effect and age group (adolescents and young adults) as fixed categorical covariate.||Influenza B Victoria lineage||1.70|0.93|
72435560|NCT02263508|144384137|SUPERIORITY||Hazard Ratio (HR)|0.86||||0.13|TWO_SIDED|95.0|0.71|1.04|||Stratified log-rank test|Stratified by randomization factors (disease stage, prior BRAF inhibitor therapy) and baseline PD-L1 status.|Cox proportional hazards model stratified by randomization factors (disease stage, prior BRAF inhibitor therapy) and baseline PD-L1 status.|||1.04|0.71|0.13
72435561|NCT02263508|144384138|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.77|TWO_SIDED|95.0|0.77|1.21|||Stratified log-rank test|Stratified by randomization factors (disease stage, prior BRAF inhibitor therapy) and baseline PD-L1 status.|Cox proportional hazards model stratified by randomization factors (disease stage, prior BRAF inhibitor therapy) and baseline PD-L1 status.|||1.21|0.77|0.77
72435562|NCT02263508|144384146|OTHER||Odds Ratio (OR)|1.88||||0.012|TWO_SIDED|95.0|1.15|3.07|||Regression, Logistic|Logistic regression stratified by randomization stratification factors (disease stage and prior BRAF inhibitor therapy) and the baseline PD-L1 status.|Adjusted odds ratio estimated using logistic regression with randomization stratification factors and baseline PD-L1 status.|||3.07|1.15|0.012
72435563|NCT02263508|144384147|OTHER||Hazard Ratio (HR)|1.05||||0.14|TWO_SIDED|95.0|0.82|1.34|||Stratified log-rank test|Stratified by randomization factors (disease stage, prior BRAF inhibitor therapy) and baseline PD-L1 status.|Cox proportional hazards model stratified by randomization factors (disease stage, prior BRAF inhibitor therapy) and baseline PD-L1 status.|||1.34|0.82|0.14
72435564|NCT02263508|144384148|OTHER||Hazard Ratio (HR)|0.88||||0.47|TWO_SIDED|95.0|0.63|1.24|||Stratified log-rank test|Stratified by randomization factors (disease stage, prior BRAF inhibitor therapy) and baseline PD-L1 status.|Cox proportional hazards model stratified by randomization factors (disease stage, prior BRAF inhibitor therapy) and baseline PD-L1 status.|||1.24|0.63|0.47
72435565|NCT02263508|144384149|OTHER||Odds Ratio (OR)|1.32||||0.081|TWO_SIDED|95.0|0.97|1.79|||Regression, Logistic|Logistic regression stratified by randomization stratification factors (disease stage and prior BRAF inhibitor therapy) and the baseline PD-L1 status.|Adjusted odds ratio estimated using logistic regression with randomization stratification factors and baseline PD-L1 status.|||1.79|0.97|0.081
72435566|NCT02263508|144384151|OTHER||Odds Ratio (OR)|1.39||||0.039|TWO_SIDED|95.0|1.02|1.9|||Regression, Logistic|Logistic regression stratified by randomization stratification factors (disease stage and prior BRAF inhibitor therapy) and the baseline PD-L1 status.|Adjusted odds ratio estimated using logistic regression with randomization stratification factors and baseline PD-L1 status.|||1.90|1.02|0.039
72383741|NCT01920555|144275709|SUPERIORITY||Mean Difference (Final Values)|4.8||||1|TWO_SIDED|95.0|-8.31|17.91||Holm's method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 1.0 mg/kg vs. midazolam at Day 3:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY\*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm's method to protect family-wise error rate in the presence of multiple testing."||17.91|-8.31|1.00
72383742|NCT01920555|144275710|SUPERIORITY||Mean Difference (Final Values)|-1.21||||1|TWO_SIDED|95.0|-3.99|1.56||Holm's method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 0.1 mg/kg vs. midazolam at Day 1:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY\*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm's method to protect family-wise error rate in the presence of multiple testing."||1.56|-3.99|1.00
72435567|NCT02263508|144384153|OTHER||Odds Ratio (OR)|1.28||||0.11|TWO_SIDED|95.0|0.94|1.75|||Regression, Logistic|Logistic regression stratified by randomization stratification factors (disease stage and prior BRAF inhibitor therapy) and the baseline PD-L1 status.|Adjusted odds ratio estimated using logistic regression with randomization stratification factors and baseline PD-L1 status.|||1.75|0.94|0.11
72435568|NCT02263508|144384154|OTHER||Odds Ratio (OR)|1.44||||0.02|TWO_SIDED|95.0|1.06|1.96|||Regression, Logistic|Logistic regression stratified by randomization stratification factors (disease stage and prior BRAF inhibitor therapy) and the baseline PD-L1 status.|Adjusted odds ratio estimated using logistic regression with randomization stratification factors and baseline PD-L1 status.|||1.96|1.06|0.020
72558121|NCT02997176|144645742|OTHER|Bioequivalence|Percent Ratio of Geometric Means|115.32|||||TWO_SIDED|90.0|77.95|170.6||||||Cmaxu was natural log-transformed and analyzed using an ANOVA model with hepatic function group as a fixed effect.||170.6|77.95|
72435569|NCT02263508|144384156|OTHER||Odds Ratio (OR)|1.59||||0.004|TWO_SIDED|95.0|1.16|2.17|||Regression, Logistic|Logistic regression stratified by randomization stratification factors (disease stage and prior BRAF inhibitor therapy) and the baseline PD-L1 status.|Adjusted odds ratio estimated using logistic regression with randomization stratification factors and baseline PD-L1 status.|||2.17|1.16|0.004
72435570|NCT02263508|144384158|OTHER||Odds Ratio (OR)|1.35||||0.058|TWO_SIDED|95.0|0.99|1.85|||Regression, Logistic|Logistic regression stratified by randomization stratification factors (disease stage and prior BRAF inhibitor therapy) and the baseline PD-L1 status.|Adjusted odds ratio estimated using logistic regression with randomization stratification factors and baseline PD-L1 status.|||1.85|0.99|0.058
72435571|NCT02263508|144384159|OTHER||Difference|0.19|STANDARD_ERROR_OF_MEAN|0.95||0.84|TWO_SIDED|95.0|-1.67|2.05|||Mixed Model for Repeated Measures|||Mixed Model for Repeated Measures include the fixed and categorical effects of treatment, visit and treatment-by-visit interaction, the fixed and continuous covariates of baseline HRQL score, randomization stratification factors (stage of disease and prior BRAF inhibitor therapy per IVRS) and baseline PD-L1 status (positive and not positive). Random subject effect was modeled using within subject-error correlation structure.||2.05|-1.67|0.84
72435572|NCT00531518|144384161|SUPERIORITY_OR_OTHER|||||||0.0034|TWO_SIDED|||||The final analysis included adjstment for site and baseline sum psychotic symptom score.|Mixed Models Analysis|||The analysis used regression discontinuity methods, in which the baseline sum scores were adjusted and centered to an equalize control and experimental conditions.||||.0034
72435573|NCT03265210|144384162|SUPERIORITY||Mean Difference (Final Values)|-1.5||||0.39|TWO_SIDED|95.0|-4.95|1.95|||t-test, 2 sided||Mean value in Relief Arm minus Mean value in Referral Arm.|Baseline||1.95|-4.95|0.39
72435574|NCT03265210|144384162|SUPERIORITY||Mean Difference (Final Values)|-3.79||||0.03|TWO_SIDED|95.0|-7.19|-0.39|||t-test, 2 sided||Mean value in Relief Arm minus Mean value in Referral Arm.|6 weeks||-0.39|-7.19|0.03
72435575|NCT03265210|144384162|SUPERIORITY||Mean Difference (Final Values)|-1.56||||0.42|TWO_SIDED|95.0|-5.38|2.26|||t-test, 2 sided||Mean value in Relief Arm minus Mean value in Referral Arm.|9 weeks||2.26|-5.38|0.42
72435576|NCT03265210|144384162|SUPERIORITY||Mean Difference (Final Values)|-3.37||||0.07|TWO_SIDED|95.0|-7.02|0.28|||t-test, 2 sided||Mean value in Relief Arm minus Mean value in Referral Arm.|12 weeks||0.28|-7.02|0.07
72435577|NCT03265210|144384163|SUPERIORITY||Mean Difference (Final Values)|-0.74||||0.17|TWO_SIDED|95.0|-1.81|0.33|||t-test, 2 sided||Mean value in Relief Arm minus Mean value in Referral Arm.|Domain 1, Baseline||0.33|-1.81|0.17
72435578|NCT03265210|144384163|SUPERIORITY||Mean Difference (Final Values)|-0.62||||0.25|TWO_SIDED|95.0|-1.68|0.44|||t-test, 2 sided||Mean value in Relief Arm minus Mean value in Referral Arm.|Domain 1, 6 weeks||0.44|-1.68|0.25
72435579|NCT03265210|144384163|SUPERIORITY||Mean Difference (Final Values)|-1.06||||0.09|TWO_SIDED|95.0|-2.29|0.17|||t-test, 2 sided||Mean value in Relief Arm minus Mean value in Referral Arm.|Domain 1, 9 weeks||0.17|-2.29|0.09
72435580|NCT03265210|144384163|SUPERIORITY||Mean Difference (Final Values)|-1.09||||0.05|TWO_SIDED|95.0|-2.19|0.01|||t-test, 2 sided||Mean value in Relief Arm minus Mean value in Referral Arm.|Domain 1, 12 weeks||0.01|-2.19|0.05
72435581|NCT03265210|144384163|SUPERIORITY||Mean Difference (Final Values)|-3.19||||0.02|TWO_SIDED|95.0|-5.9|-0.48|||t-test, 2 sided||Mean value in Relief Arm minus Mean value in Referral Arm.|Domain 2, Baseline||-0.48|-5.90|0.02
72435582|NCT03265210|144384163|SUPERIORITY||Mean Difference (Final Values)|-4.3||||0.003|TWO_SIDED|95.0|-7.06|-1.54|||t-test, 2 sided||Mean value in Relief Arm minus Mean value in Referral Arm.|Domain 2, 6 weeks||-1.54|-7.06|0.003
72435583|NCT03265210|144384163|SUPERIORITY||Mean Difference (Final Values)|-5.95||||0.0001|TWO_SIDED|95.0|-8.85|-3.05|||t-test, 2 sided||Mean value in Relief Arm minus Mean value in Referral Arm.|Domain 2, 9 weeks||-3.05|-8.85|0.0001
72435584|NCT03265210|144384163|SUPERIORITY||Mean Difference (Final Values)|-4.35||||0.007|TWO_SIDED|95.0|-7.46|-1.24|||t-test, 2 sided||Mean value in Relief Arm minus Mean value in Referral Arm.|Domain 2, 12 weeks||-1.24|-7.46|0.007
72435585|NCT03265210|144384164|SUPERIORITY||Mean Difference (Final Values)|1.11||||0.0003|TWO_SIDED|95.0|0.53|1.69|||t-test, 2 sided||Mean value in Relief Arm minus Mean value in Referral Arm.|Domain 1||1.69|0.53|0.0003
72435586|NCT03265210|144384164|SUPERIORITY||Mean Difference (Final Values)|0.52||||0.001|TWO_SIDED|95.0|0.21|0.83|||t-test, 2 sided||Mean value in Relief Arm minus Mean value in Referral Arm.|Domain 2||0.83|0.21|0.001
72383743|NCT01920555|144275710|SUPERIORITY||Mean Difference (Final Values)|0.76||||0.17|TWO_SIDED|95.0|-1.9|3.43||Holm's method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 0.2 mg/kg vs. midazolam at Day 1:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY\*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm's method to protect family-wise error rate in the presence of multiple testing."||3.43|-1.90|0.17
72383744|NCT01920555|144275710|SUPERIORITY||Mean Difference (Final Values)|-2.74||||0.3|TWO_SIDED|95.0|-5.32|-0.16||Holm's method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 0.5 mg/kg vs. midazolam at Day 1:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY\*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm's method to protect family-wise error rate in the presence of multiple testing."||-0.16|-5.32|0.30
72383745|NCT01920555|144275710|SUPERIORITY||Mean Difference (Final Values)|-0.71||||1|TWO_SIDED|95.0|-3.35|1.93||Holm's method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 1.0 mg/kg vs. midazolam at Day 1:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY\*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm's method to protect family-wise error rate in the presence of multiple testing."||1.93|-3.35|1.00
72383746|NCT01920555|144275710|SUPERIORITY||Mean Difference (Final Values)|-0.29||||1|TWO_SIDED|95.0|-3.25|2.66||Holm's method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 0.1 mg/kg vs. midazolam at Day 3:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY\*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm's method to protect family-wise error rate in the presence of multiple testing."||2.66|-3.25|1.00
72383747|NCT01920555|144275710|SUPERIORITY||Mean Difference (Final Values)|2.76||||0.39|TWO_SIDED|95.0|-0.06|5.59||Holm's method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 0.2 mg/kg vs. midazolam at Day 3:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY\*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm's method to protect family-wise error rate in the presence of multiple testing."||5.59|-0.06|0.39
72383748|NCT01920555|144275710|SUPERIORITY||Mean Difference (Final Values)|-1.17||||1|TWO_SIDED|95.0|-3.91|1.58||Holm's method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 0.5 mg/kg vs. midazolam at Day 3:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY\*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm's method to protect family-wise error rate in the presence of multiple testing."||1.58|-3.91|1.00
72383749|NCT01920555|144275710|SUPERIORITY||Mean Difference (Final Values)|-0.43||||1|TWO_SIDED|95.0|-3.22|2.35||Holm's method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 1.0 mg/kg vs. midazolam at Day 3:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY\*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm's method to protect family-wise error rate in the presence of multiple testing."||2.35|-3.22|1.00
72383750|NCT01193660|144275735|SUPERIORITY_OR_OTHER_LEGACY||Wilks' Lambda (group*visit effect)|2.59|||<|0.05||95.0|||||Repeated Measure ANOVA|||In our analysis, the null hypothesis is that the effects of 3 experimental groups are same, and the alternative hypothesis is that the therapeutic effect of combination intervention Group (Umbilical Cord Blood + Erythropoietin + Rehabilitation) is higher than that of either Erythropoietin + Rehabilitation or Rehabilitation Group. This is a pilot study and power calculation was not applicable. The sample size of each group is over 30 and is considered to follow approximately normal distribution.||||<0.05
72383751|NCT01193660|144275736|SUPERIORITY_OR_OTHER_LEGACY||Wilks' Lambda (group*visit effect)|3.94|||<|0.05||95.0|||||Repeated Measure ANOVA|||The null hypothesis is that in terms of K-BSID-II MENTAL Scale, the effects of 3 groups are same, and the alternative one is that the therapeutic effect of combination intervention Group (Umbilical Cord Blood + Erythropoietin + Rehabilitation) is higher than that of either Erythropoietin + Rehabilitation or Rehabilitation Group. This is a pilot study and power calculation was not applicable. The sample size of each group is over 30 and is considered to follow approximately normal distribution.||||<0.05
72435587|NCT03265210|144384164|SUPERIORITY||Mean Difference (Final Values)|0.96||||0.002|TWO_SIDED|95.0|0.36|1.56|||t-test, 2 sided||Mean value in Relief Arm minus Mean value in Referral Arm.|Domain 3||1.56|0.36|0.002
72435588|NCT02281318|144384174|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.7|||<|0.001|TWO_SIDED|95.0|-10.5|-4.9|||Mixed model repeated measures analysis|||||-4.9|-10.5|<0.001
72435589|NCT02281318|144384175|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|120.0||||0.001|TWO_SIDED|95.0|47.0|192.0|||Mixed model repeated measures analysis|||||192|47|0.001
72435590|NCT02281318|144384176|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.23|||<|0.001|TWO_SIDED|95.0|1.55|3.22|||Regression, Logistic|||||3.22|1.55|<0.001
72494334|NCT01703858|144517598|NON_INFERIORITY_OR_EQUIVALENCE|Assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMeans) with acceptance range of 80.00 to 125.00%|Ratio of Geometric means (%)|89.26|STANDARD_DEVIATION|25.3||0.1261|TWO_SIDED|90.0|75.893|104.973|||ANOVA|Relative bioavailability was estimated by the ratios of the adjusted geometric means. CIs were calculated based on the residual error.|Analysis of variance includes the effects: sequence, subjects nested within sequences, period and treatment in crossover; subject and treatment in fixed sequence. Standard deviation is actually Intra individual geometric coefficient of variation.|B : BI-113608 vs. A : BI-113608 - Comparison with oral solution||104.973|75.893|0.1261
72494335|NCT01703858|144517598|NON_INFERIORITY_OR_EQUIVALENCE|Assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMeans) with acceptance range of 80.00 to 125.00%|Ratio of Geometric means (%)|54.57|STANDARD_DEVIATION|47.4||0.9808|TWO_SIDED|90.0|40.711|73.157|||ANOVA|Relative bioavailability was estimated by the ratios of the adjusted geometric means. CIs were calculated based on the residual error.|Analysis of variance includes the effects: sequence, subjects nested within sequences, period and treatment in crossover; subject and treatment in fixed sequence. Standard deviation is actually Intra individual geometric coefficient of variation.|C : BI-113608 vs. B : BI-113608 - Food effect||73.157|40.711|0.9808
72558122|NCT02997176|144645742|OTHER|Bioequivalence|Percent Ratio of Geometric Means|132.26|||||TWO_SIDED|90.0|81.87|213.67||||||Cmaxu was natural log-transformed and analyzed using an ANOVA model with hepatic function group as a fixed effect.||213.67|81.87|
72558123|NCT02997176|144645743|OTHER|Bioequivalence|Percent Ratio of Geometric Means|124.4|||||TWO_SIDED|90.0|85.19|181.66||||||AUC0-24 was natural log-transformed and analyzed using an ANOVA model with hepatic function group as a fixed effect.||181.66|85.19|
72383752|NCT01193660|144275737|SUPERIORITY_OR_OTHER_LEGACY||Wilks' Lambda (group*visit effect)|2.7|||<|0.05||95.0|||||Repeated Measure ANOVA|||The null hypothesis is that in terms of K-BSID-II MOTOR Scale, the effects of 3 groups are same, and the alternative one is that the therapeutic effect of combination intervention Group (Umbilical Cord Blood + Erythropoietin + Rehabilitation) is higher than that of either Erythropoietin + Rehabilitation or Rehabilitation Group. This is a pilot study and power calculation was not applicable. The sample size of each group is over 30 and is considered to follow approximately normal distribution.||||<0.05
72435591|NCT02281318|144384177|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|||<|0.001|TWO_SIDED|95.0|-0.58|-0.22|||Mixed model repeated measures analysis|||||-0.22|-0.58|<0.001
72435592|NCT00812877|144384178|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.35||||0.046|TWO_SIDED|95.0|1.19|4.66||A clustered permutation test with 10,000 random permutations based on the log rank test statistic was used for the primary treatment comparison to account for censoring and to ensure proper test size given the number of practices.|Log Rank||A confirmatory analysis, adjusted for patient, dentist, and tooth characteristics, and follow-up time, was performed using marginal proportional hazards regression with robust standard error estimates accounting for clustering by practice.|||4.66|1.19|.046
72435593|NCT02174562|144384239|SUPERIORITY||Risk Ratio (RR)|1.21||||0.31|TWO_SIDED|95.0|0.84|1.75||0.05 was the a priori level of significance.|Poisson regression with robust SEs||PC-OT is the numerator, Enhanced Usual care is the denominator|Null hypothesis is that the Relative Risk of reduction of HbA1C \>=0.5 for PCOT vs EUC is 1.||1.75|0.84|0.31
72435594|NCT02174562|144384240|SUPERIORITY|||||||0.87|||||||Mixed Models Analysis|P-value is for comparison of least squares means for period 2 (months 4-6).||Mixed effects linear regression was used to model the percentage of doses taken each month. Fixed effects were period (1-3 months, 4-6 months, 7-9 months, 10-12 months), randomization group, randomization by period interaction, stratification group, age, and run-in percentage doses taken. The outcome was transformed using the arcsin-square root transformation prior to analysis. A first-order autoregressive correlation structure was assumed.||||0.87
72435595|NCT00094809|144384272|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.19|||<|0.0001||95.0|0.1|0.37|||Mantel Haenszel|Adjusted for chemotherapy regimen|Common odds ratio of the pegfilgrastim group compared to the placebo group|||0.37|0.10|<0.0001
72435596|NCT00094809|144384273|SUPERIORITY_OR_OTHER||Treatment difference|-18.0|||<|0.0001||95.0|-26.2|-9.8|||Mantel Haenszel|Adjusted for chemotherapy regimen|Treatment difference in percentage of participants (pegfilgrastim group - placebo group)|||-9.8|-26.2|<0.0001
72435597|NCT00094809|144384274|SUPERIORITY_OR_OTHER||Treatment difference|-12.0||||0.0646||95.0|-23.7|0.5|||Mantel Haenszel|Adjusted for chemotherapy regimen|Treatment difference in percentage of participants (pegfilgrastim group - placebo group)|||0.5|-23.7|0.0646
72435598|NCT00094809|144384275|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.27||||0.0384||95.0|0.07|1.0|||Mantel Haenszel|Adjusted for chemotherapy regimen|Common odds ratio of pegfilgrastim group compared to placebo group|||1.00|0.07|0.0384
72435599|NCT00094809|144384276|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.73||||0.5514||95.0|0.26|2.04|||Mantel Haenszel|Adjusted for chemotherapy regimen|Common odds ratio for pegfilgrastim group compared to placebo group|||2.04|0.26|0.5514
72435600|NCT00094809|144384278|SUPERIORITY_OR_OTHER||Treatment difference|-3.5||||0.5434||95.0|-14.8|7.8|||Mantel Haenszel|Adjusted for chemotherapy regimen|Treatment difference (pegfilgrastim group - placebo group) in the percentage of participants with a complete or partial response|||7.8|-14.8|0.5434
72435601|NCT00094809|144384279|SUPERIORITY_OR_OTHER||Treatment difference|-12.1||||||95.0|-28.1|4.0|||||Kaplan-Meier estimates of the difference in percent mortality for the pegfilgrastim group - placebo group. Median survival time was not reached for the pegfilgrastim group.|||4.0|-28.1|
72435602|NCT00094809|144384280|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.23||||0.0457||95.0|0.05|1.09|||Mantel Haenszel|Adjusted for chemotherapy regimen|Common odds ratio for pegfilgrastim group compared to placebo group|||1.09|0.05|0.0457
72435603|NCT00094809|144384281|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.71||||0.3792||95.0|0.32|1.53|||Mantel Haenszel|Adjusted for chemotherapy regimen|Common odds ratio of the pegfilgrastim group compared to the placebo group|||1.53|0.32|0.3792
72435604|NCT02057718|144384332|OTHER|Null hypothesis (H0): mean change from baseline to Week 13 is zero. The null hypothesis was tested for each of the 2 PFIC subgroups and overall; the change in the overall population is presented here.|Mean Difference (Net)|-23.304|STANDARD_DEVIATION|160.9748|||TWO_SIDED|95.0|-82.35|35.742||||||This analysis shows the change from baseline to Week 13 in sBA levels for the overall Modified Intent-to-treat Population. Even though a comparison of PFIC1 vs PFIC2 (overall) is noted, the results are the change from baseline for all participants and is not comparative.||35.742|-82.35|
72435605|NCT02503202|144384338|EQUIVALENCE|Lot consistency requires the 95% confidence interval of the GMT ratio of \>0.5 and ≤2.0 for the primary analysis and \>0.67 and ≤1.5 for the secondary analysis.|GMT ratio (Lot A / Lot B)|0.94|||<|0.001|TWO_SIDED|95.0|0.77|1.14||Primary analysis: a p-value \<0.025 supported the conclusion of equivalence. If equivalence was established for the 3 pairwise comparisons, the lots would be considered to be consistent.|ANOVA|||||1.14|0.77|<0.001
72435606|NCT02503202|144384338|EQUIVALENCE|Lot consistency requires the 95% confidence interval of the GMT ratio of \>0.5 and ≤2.0 for the primary analysis and \>0.67 and ≤1.5 for the secondary analysis.|GMT ratio (Lot A / Lot C)|0.88|||<|0.001|TWO_SIDED|95.0|0.71|1.09||Primary analysis: a p-value \<0.025 supported the conclusion of equivalence. If equivalence was established for the 3 pairwise comparisons, the lots would be considered to be consistent.|ANOVA|||||1.09|0.71|<0.001
72435607|NCT02503202|144384338|EQUIVALENCE|Lot consistency requires the 95% confidence interval of the GMT ratio of \>0.5 and ≤2.0 for the primary analysis and \>0.67 and ≤1.5 for the secondary analysis.|GMT ratio (Lot B / Lot C)|0.94|||<|0.001|TWO_SIDED|95.0|0.77|1.15||Primary analysis: a p-value \<0.025 supported the conclusion of equivalence. If equivalence was established for the 3 pairwise comparisons, the lots would be considered to be consistent.|ANOVA|||||1.15|0.77|<0.001
72435608|NCT02503202|144384339|OTHER||Risk Difference (RD)|1.1||||0.368|TWO_SIDED|95.0|-1.5|4.0|||Miettinen & Nurminen||Risk difference is Lot A - Lot B|||4.0|-1.5|0.368
72435609|NCT02503202|144384339|OTHER||Risk Difference (RD)|0.0||||0.989|TWO_SIDED|95.0|-3.1|3.0|||Miettinen & Nurminen||Risk difference is Lot A - Lot C|||3.0|-3.1|0.989
72435610|NCT02503202|144384339|OTHER||Risk Difference (RD)|-1.1||||0.361|TWO_SIDED|95.0|-4.1|1.5|||Miettinen & Nurminen||Risk difference is Lot B - Lot C|||1.5|-4.1|0.361
72435611|NCT02503202|144384339|OTHER||Risk Difference (RD)|1.2||||0.214|TWO_SIDED|95.0|-1.7|3.3|||Miettinen & Nurminen||Risk difference is High-dose Lot - Placebo|||3.3|-1.7|0.214
72435612|NCT02503202|144384340|OTHER||Risk Difference (RD)|4.1||||0.16|TWO_SIDED|95.0|-1.6|9.9|||Miettinen & Nurminen||Risk difference is Lot A - Lot B|Injection site erythema||9.9|-1.6|0.160
72435613|NCT02503202|144384340|OTHER||Risk Difference (RD)|-0.1||||0.971|TWO_SIDED|95.0|-6.2|6.0|||Miettinen & Nurminen||Risk difference is Lot A - Lot C|Injection site erythema||6.0|-6.2|0.971
72435614|NCT02503202|144384340|OTHER||Risk Difference (RD)|-4.2||||0.151|TWO_SIDED|95.0|-10.0|1.5|||Miettinen & Nurminen||Risk difference is Lot B - Lot C|Injection site erythema||1.5|-10.0|0.151
72435615|NCT02503202|144384340|OTHER||Risk Difference (RD)|5.8||||0.016|TWO_SIDED|95.0|1.4|9.9|||Miettinen & Nurminen||Risk difference is High-dose Lot - Placebo|Injection site erythema||9.9|1.4|0.016
72435616|NCT02503202|144384340|OTHER||Risk Difference (RD)|-6.2||||0.12|TWO_SIDED|95.0|-14.0|1.6|||Miettinen & Nurminen||Risk difference is Lot A - Lot B|Injection site pain||1.6|-14.0|0.120
72435617|NCT02503202|144384340|OTHER||Risk Difference (RD)|-3.5||||0.38|TWO_SIDED|94.0|-11.4|4.4|||Miettinen & Nurminen||Risk difference is Lot A - Lot C|Injection site pain||4.4|-11.4|0.380
72435618|NCT02503202|144384340|OTHER||Risk Difference (RD)|2.7||||0.499|TWO_SIDED|95.0|-5.1|10.4|||Miettinen & Nurminen||Risk difference is Lot B - Lot C|Injection site pain||10.4|-5.1|0.499
72435619|NCT02503202|144384340|OTHER||Risk Difference (RD)|54.9|||<|0.001|TWO_SIDED|95.0|46.2|62.3|||Miettinen & Nurminen||Risk difference is High-dose Lot - Placebo|Injection site pain||62.3|46.2|<0.001
72435620|NCT02503202|144384340|OTHER||Risk Difference (RD)|4.0||||0.202|TWO_SIDED|95.0|-2.2|10.3|||Miettinen & Nurminen||Risk difference is Lot A - Lot B|Injection site swelling||10.3|-2.2|0.202
72435621|NCT02503202|144384340|OTHER||Risk Difference (RD)|-0.5||||0.878|TWO_SIDED|95.0|-7.1|6.1|||Miettinen & Nurminen||Risk difference is Lot A - Lot C|Injection site swelling||6.1|-7.1|0.878
72435622|NCT02503202|144384340|OTHER||Risk Difference (RD)|-4.6||||0.154|TWO_SIDED|95.0|-10.9|1.7|||Miettinen & Nurminen||Risk difference is Lot B - Lot C|Injection site swelling||1.7|-10.9|0.154
72435623|NCT02503202|144384340|OTHER||Risk Difference (RD)|13.1|||<|0.001|TWO_SIDED|95.0|7.4|18.6|||Miettinen & Nurminen||Risk difference is High-dose Lot - Placebo|Injection site swelling||18.6|7.4|<0.001
72558124|NCT02997176|144645743|OTHER|Bioequivalence|Percent Ratio of Geometric Means|113.42|||||TWO_SIDED|90.0|73.9|174.07||||||AUC0-24 was natural log-transformed and analyzed using an ANOVA model with hepatic function group as a fixed effect.||174.07|73.90|
72435624|NCT02503202|144384341|OTHER||Risk Difference (RD)|4.6||||0.176|TWO_SIDED|95.0|-2.1|11.4|||Miettinen & Nurminen||Risk difference is Lot A - Lot B|||11.4|-2.1|0.176
72435625|NCT02503202|144384341|OTHER||Risk Difference (RD)|-1.1||||0.769|TWO_SIDED|95.0|-8.2|6.0|||Miettinen & Nurminen||Risk difference is Lot A - Lot C|||6.0|-8.2|0.769
72435626|NCT02503202|144384341|OTHER||Risk Difference (RD)|-5.7||||0.1|TWO_SIDED|95.0|-12.5|1.1|||Miettinen & Nurminen||Risk difference is Lot B - Lot C|||1.1|-12.5|0.100
72435627|NCT02503202|144384341|OTHER||Risk Difference (RD)|31.4|||<|0.001|TWO_SIDED|95.0|25.6|37.5|||Miettinen & Nurminen||Risk difference is High-dose Lot - Placebo|||37.5|25.6|<0.001
72435628|NCT02503202|144384342|OTHER||Risk Difference (RD)|0.0||||0.983|TWO_SIDED|95.0|-4.2|4.1|||Miettinen & Nurminen||Risk difference is Lot A - Lot B|Arthralgia||4.1|-4.2|0.983
72435629|NCT02503202|144384342|OTHER||Risk Difference (RD)|-0.8||||0.699|TWO_SIDED|95.0|-5.1|3.4|||Miettinen & Nurminen||Risk difference is Lot A - Lot C|Arthralgia||3.4|-5.1|0.699
72435630|NCT02503202|144384342|OTHER||Risk Difference (RD)|-0.8||||0.716|TWO_SIDED|95.0|-5.1|3.5|||Miettinen & Nurminen||Risk difference is Lot B - Lot C|Arthralgia||3.5|-5.1|0.716
72435631|NCT02503202|144384342|OTHER||Risk Difference (RD)|6.2||||0.012|TWO_SIDED|95.0|1.8|10.4|||Miettinen & Nurminen||Risk difference is High-dose Lot - Placebo|Arthralgia||10.4|1.8|0.012
72435632|NCT02503202|144384342|OTHER||Risk Difference (RD)|0.7||||0.677|TWO_SIDED|95.0|-2.9|4.4|||Miettinen & Nurminen||Risk difference is Lot A - Lot B|Arthritis||4.4|-2.9|0.677
72435633|NCT02503202|144384342|OTHER||Risk Difference (RD)|1.9||||0.25|TWO_SIDED|95.0|-1.4|5.4|||Miettinen & Nurminen||Risk difference is Lot A - Lot C|Arthritis||5.4|-1.4|0.250
72435634|NCT02503202|144384342|OTHER||Risk Difference (RD)|1.1||||0.46|TWO_SIDED|95.0|-2.1|4.5|||Miettinen & Nurminen||Risk difference is Lot B - Lot C|Arthritis||4.5|-2.1|0.460
72435635|NCT02503202|144384342|OTHER||Risk Difference (RD)|3.1||||0.041|TWO_SIDED|95.0|0.2|6.0|||Miettinen & Nurminen||Risk difference is High-dose Lot - Placebo|Arthritis||6.0|0.2|0.041
72435636|NCT02503202|144384343|OTHER||Risk Difference (RD)|-1.5||||0.353|TWO_SIDED|95.0|-5.1|1.9|||Miettinen & Nurminen||Risk difference is Lot A - Lot B|||1.9|-5.1|0.353
72435637|NCT02503202|144384343|OTHER||Risk Difference (RD)|-0.8||||0.62|TWO_SIDED|95.0|-4.2|2.5|||Miettinen & Nurminen||Risk difference is Lot A - Lot C|||2.5|-4.2|0.620
72435638|NCT02503202|144384343|OTHER||Risk Difference (RD)|0.8||||0.663|TWO_SIDED|95.0|-2.9|4.5|||Miettinen & Nurminen||Risk difference is Lot B - Lot C|||4.5|-2.9|0.663
72435639|NCT02503202|144384343|OTHER||Risk Difference (RD)|2.3||||0.202|TWO_SIDED|95.0|-1.8|5.7|||Miettinen & Nurminen||Risk difference is High-dose Lot - Placebo|||5.7|-1.8|0.202
72435640|NCT02503202|144384344|OTHER||Risk Difference (RD)|0.7||||0.483|TWO_SIDED|95.0|-1.6|3.3|||Miettinen & Nurminen||Risk difference is Lot A - Lot B|||3.3|-1.6|0.483
72435641|NCT02503202|144384344|OTHER||Risk Difference (RD)|0.4||||0.746|TWO_SIDED|95.0|-2.2|3.0|||Miettinen & Nurminen||Risk difference is Lot A - Lot C|||3.0|-2.2|0.746
72435642|NCT02503202|144384344|OTHER||Risk Difference (RD)|-0.4||||0.704|TWO_SIDED|95.0|-2.8|2.0|||Miettinen & Nurminen||Risk difference is Lot B - Lot C|||2.0|-2.8|0.704
72435643|NCT02503202|144384344|OTHER||Risk Difference (RD)|1.5||||0.151|TWO_SIDED|95.0|-1.3|3.9|||Miettinen & Nurminen||Risk difference is High-dose Lot - Placebo|||3.9|-1.3|0.151
72435644|NCT04897737|144384345|SUPERIORITY||Risk Ratio (RR)|1.83|||<|0.001|TWO_SIDED|95.0|1.19|2.82|||Mixed Models Analysis|||All analyses were by intention-to-treat. In the case of missing outcomes for participants who did not return for the follow-up visit, we assigned outcome values of the following: poor PrEP adherence (TFV undetected) and partner not tested for HIV. We constructed univariate Poisson regression models with robust standard errors to examine the predictors of outcomes of interests. Model results are presented as crude risk ratios (RRs) and risk differences (RDs) with 95% CIs.||2.82|1.19|<0.001
72435645|NCT04897737|144384346|SUPERIORITY||Risk Ratio (RR)|3.89|||<|0.001|TWO_SIDED|95.0|2.08|7.27|||Regression, Linear|||All analyses were by intention-to-treat. In the case of missing outcomes for participants who did not return for the follow-up visit, we assigned outcome values of the following: poor PrEP adherence (TFV undetected) and partner not tested for HIV. We constructed univariate Poisson regression models with robust standard errors to examine the predictors of outcomes of interests. Model results are presented as crude risk ratios (RRs) and 95% CIs.|RD=49.1% (95% CI=32.8, 65.3), p\<0.001|7.27|2.08|<0.001
72435646|NCT04059237|144384348|OTHER||||||<|0.001||||||Repeated measures ANOVA evaluated change in outcome variables across the study time points.|ANOVA|||||||<0.001
72435647|NCT04059237|144384349|OTHER||||||<|0.001||||||Repeated measures ANOVA evaluated change in outcome variables across the study time points.|ANOVA|||||||<.001
72435648|NCT04059237|144384350|OTHER||||||<|0.001||||||Repeated measures ANOVA evaluated change in outcome variables across the study time points.|ANOVA|||||||<0.001
72435649|NCT04059237|144384351|OTHER|||||||0.1||||||Repeated measures ANOVA evaluated change in outcome variables across the study time points.|ANOVA|||||||0.10
72435650|NCT04059237|144384352|OTHER|||||||0.01||||||Repeated measures ANOVA evaluated change in outcome variables across the study time points.|ANOVA|||||||.01
72435651|NCT04059237|144384353|OTHER|||||||0.59||||||Repeated measures ANOVA evaluated change in outcome variables across the study time points.|ANOVA|||||||0.59
72435652|NCT04059237|144384354|OTHER|||||||0.02||||||Repeated measures ANOVA evaluated change in outcome variables across the study time points.|ANOVA|||||||0.02
72435653|NCT04059237|144384355|OTHER|||||||0.52||||||Repeated measures ANOVA evaluated change in outcome variables across the study time points.|ANOVA|||||||0.52
72435654|NCT04059237|144384356|OTHER|||||||0.08||||||Repeated measures ANOVA evaluated change in outcome variables across the study time points.|ANOVA|||||||0.08
72435655|NCT01460342|144384375|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.5|STANDARD_ERROR_OF_MEAN|0.5|<|0.001|TWO_SIDED|95.0|-2.4|-0.6|||Mixed Models Analysis|||||-0.6|-2.4|<0.001
72435656|NCT01460342|144384376|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.3|STANDARD_ERROR_OF_MEAN|0.4|<|0.001|TWO_SIDED|95.0|-2.0|-0.5||The p-value is for the change from baseline in the IPSS Total Score at Week 4.|Mixed Models Analysis|||||-0.5|-2.0|<0.001
72435657|NCT01460342|144384376|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.2|STANDARD_ERROR_OF_MEAN|0.4||0.003|TWO_SIDED|95.0|-2.0|-0.4||The p-value is for the change from baseline in the IPSS Total Score at Week 8.|Mixed Models Analysis|||||-0.4|-2.0|0.003
72435658|NCT01460342|144384377|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.2||0.09|TWO_SIDED|95.0|-0.6|0.0||The p-value was for the change from baseline in the IPSS Storage (Irritative) Subscore at Week 4.|Mixed Models Analysis|||||0.0|-0.6|0.090
72435659|NCT01460342|144384377|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.2||0.011|TWO_SIDED|95.0|-0.8|-0.1||The p-value was for the change from baseline in the IPSS Storage (Irritative) Subscore at Week 8.|Mixed Models Analysis|||||-0.1|-0.8|0.011
72435660|NCT01460342|144384377|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.2||0.002|TWO_SIDED|95.0|-0.9|-0.2||The p-value was for the change from baseline in the IPSS Storage (Irritative) Subscore at Week 12.|Mixed Models Analysis|||||-0.2|-0.9|0.002
72435661|NCT01460342|144384378|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0|STANDARD_ERROR_OF_MEAN|0.3|<|0.001|TWO_SIDED|95.0|-1.5|-0.4||The p-value was for the change from baseline in the IPSS Voiding (Obstructive) Subscore at Week 4.|Mixed Models Analysis|||||-0.4|-1.5|<0.001
72435662|NCT01460342|144384378|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8|STANDARD_ERROR_OF_MEAN|0.3||0.007|TWO_SIDED|95.0|-1.3|-0.2||The p-value was for the change from baseline in the IPSS Voiding (Obstructive) Subscore at Week 8.|Mixed Models Analysis|||||-0.2|-1.3|0.007
72435663|NCT01460342|144384378|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9|STANDARD_ERROR_OF_MEAN|0.3||0.002|TWO_SIDED|95.0|-1.5|-0.3||The p-value was for the change from baseline in the IPSS Voiding (Obstructive) Subscore at Week 12.|Mixed Models Analysis|||||-0.3|-1.5|0.002
72435664|NCT01460342|144384379|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.1||0.277|TWO_SIDED|95.0|-0.2|0.1||The p-value was for the change from baseline in the IPSS QoL Index Score at Week 4.|Mixed Models Analysis|||||0.1|-0.2|0.277
72435665|NCT01460342|144384379|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.1||0.17|TWO_SIDED|95.0|-0.3|0.1||The p-value was for the change from baseline in the IPSS QoL Index Score at Week 8.|Mixed Models Analysis|||||0.1|-0.3|0.170
72435666|NCT01460342|144384379|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.1||0.038|TWO_SIDED|95.0|-0.4|0.0||The p-value was for the change from baseline in the IPSS QoL Index Score at Week 12.|Mixed Models Analysis|||||-0.0|-0.4|0.038
72383753|NCT01193660|144275739|SUPERIORITY_OR_OTHER_LEGACY|||||||0.05||95.0||||The baseline and post-therapy data of each group were compared using paired t-test statistics.|t-test, 2 sided|Voxels with an uncorrected p-value of \<0.05 were considered significant, and an extent threshold Ke of 100 voxels was set by SPM implanted in Matlab.||In our analysis, the null hypothesis is that the effects of three experimental groups are same each other, and the alternative hypothesis is that the therapeutic effect of combination intervention Group (Umbilical Cord Blood + Erythropoietin + Rehabilitation) has much higher than that of either Erythropoietin + Rehabilitation Group or Rehabilitation Group. This study is a pilot study and therefore, power calculation was not applicable in our study. The sample size of each group is more than 30.||||0.05
72435667|NCT01460342|144384380|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The p-value was from the Cochran-Mantel-Haenszel test adjusted for baseline severity of benign prostatic hyperplasia lower urinary tract symptoms (BPH-LUTS) and previous alpha-blocker therapy.|Cochran-Mantel-Haenszel|||||||<0.001
72558125|NCT02997176|144645743|OTHER|Bioequivalence|Percent Ratio of Geometric Means|95.68|||||TWO_SIDED|90.0|67.9|134.83||||||AUC0-24 was natural log-transformed and analyzed using an ANOVA model with hepatic function group as a fixed effect.||134.83|67.90|
72383754|NCT01193660|144275741|SUPERIORITY_OR_OTHER_LEGACY||interaction of group and visit|0.9|||<|0.05||95.0|||||Repeated Measure ANOVA|||In our analysis, the null hypothesis is that the effects of 3 experimental groups are same, and the alternative hypothesis is that the therapeutic effect of combination intervention Group (Umbilical Cord Blood + Erythropoietin + Rehabilitation) is higher than that of either Erythropoietin + Rehabilitation or Rehabilitation Group. This is a pilot study and power calculation was not applicable. The sample size of each group is over 30 and is considered to follow approximately normal distribution.||||<0.05
72383755|NCT01193660|144275742|SUPERIORITY_OR_OTHER_LEGACY||Wilks' Lambda (group*visit effect)|1.279|||<|0.05||95.0|||||Repeated Measure ANOVA|||In our analysis, the null hypothesis is that the effects of 3 experimental groups are same, and the alternative hypothesis is that the therapeutic effect of combination intervention Group (Umbilical Cord Blood + Erythropoietin + Rehabilitation) is higher than that of either Erythropoietin + Rehabilitation or Rehabilitation Group. This is a pilot study and power calculation was not applicable. The sample size of each group is over 30 and is considered to follow approximately normal distribution.||||<0.05
72383756|NCT01193660|144275743|SUPERIORITY_OR_OTHER_LEGACY||Wilks' Lambda (group*visit effect)|0.996|||<|0.05||95.0|||||Repeated Measure ANOVA|||In our analysis, the null hypothesis is that the effects of 3 experimental groups are same, and the alternative hypothesis is that the therapeutic effect of combination intervention Group (Umbilical Cord Blood + Erythropoietin + Rehabilitation) is higher than that of either Erythropoietin + Rehabilitation or Rehabilitation Group. This is a pilot study and power calculation was not applicable. The sample size of each group is over 30 and is considered to follow approximately normal distribution.||||<0.05
72383757|NCT01193660|144275744|SUPERIORITY_OR_OTHER_LEGACY||Wilks' Lambda (group*visit effect)|0.56|||<|0.05||95.0|||||Repeated Measure ANOVA|||In our analysis, the null hypothesis is that the effects of 3 experimental groups are same, and the alternative hypothesis is that the therapeutic effect of combination intervention Group (Umbilical Cord Blood + Erythropoietin + Rehabilitation) is higher than that of either Erythropoietin + Rehabilitation or Rehabilitation Group. This is a pilot study and power calculation was not applicable. The sample size of each group is over 30 and is considered to follow approximately normal distribution.||||<0.05
72383758|NCT01193660|144275745|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05|||||||Fisher Exact|We compared the ratio of participants with a certain adverse event (AE) and without the AE between three groups using Fisher Exact test.||||||<0.05
72383759|NCT01886716|144275746|SUPERIORITY_OR_OTHER||Slope|-0.8|STANDARD_ERROR_OF_MEAN|0.95|=|0.4|TWO_SIDED||||||Mixed Models Analysis||F(1,517) = .71|"The analyses used multilevel modeling to capture both the trajectories of symptoms within individuals (i.e., level 1) and the hypothesized between-subject moderators of these trajectories, alcohol and anxiety attention training (i.e., level 2) across all 7 time points.~Note, although all 4 groups are included in this analysis, this analysis specifically compares anxiety vs. control training."||||=.40
72383760|NCT01886716|144275746|SUPERIORITY_OR_OTHER||Slope|0.27|STANDARD_ERROR_OF_MEAN|0.95|=|0.78|TWO_SIDED||||||Mixed Models Analysis||F(1,517) = .08|"The analyses used multilevel modeling to capture both the trajectories of symptoms within individuals (i.e., level 1) and the hypothesized between-subject moderators of these trajectories, alcohol and anxiety attention training (i.e., level 2) across all 7 time points.~Note, although all 4 groups are included in this analysis, this analysis specifically compares alcohol vs. control training."||||=.78
72383761|NCT01886716|144275747|SUPERIORITY_OR_OTHER||Slope|-0.03|STANDARD_ERROR_OF_MEAN|0.07|=|0.67|TWO_SIDED||||||Mixed Models Analysis||F(1,517) = .18|"The analyses used multilevel modeling to capture both the trajectories of symptoms within individuals (i.e., level 1) and the hypothesized between-subject moderators of these trajectories, alcohol and anxiety attention training (i.e., level 2) across all 7 time points.~Note, although all 4 groups are included in this analysis, this analysis specifically compares alcohol vs. control training"||||=.67
72383762|NCT01886716|144275747|SUPERIORITY_OR_OTHER||Slope|0.07|STANDARD_ERROR_OF_MEAN|0.07|=|0.32|TWO_SIDED||||||Mixed Models Analysis||F(1,517) = 1.01|"The analyses used multilevel modeling to capture both the trajectories of symptoms within individuals (i.e., level 1) and the hypothesized between-subject moderators of these trajectories, alcohol and anxiety attention training (i.e., level 2) across all 7 time points.~Note, although all 4 groups are included in this analysis, this analysis specifically compares anxiety vs. control training"||||=.32
72383763|NCT01973569|144275777|SUPERIORITY|||||||0.0235||||||The hierarchical testing procedure was applied for multiple comparisons of the primary endpoint. First, comparison between AMG 162 60mg Q3M vs placebo is tested. Only if it is rejected, comparison of AMG 162 60mg Q6M vs placebo is formally tested.|van Elteren stratified rank test|van Elteren stratified rank test adjusting for baseline use of glucocorticoid was used.||||||0.0235
72383764|NCT01973569|144275778|SUPERIORITY|||||||0.036|||||||van Elteren stratified rank test|van Elteren stratified rank test adjusting for baseline use of glucocorticoid was used.||||||0.0360
72383765|NCT01973569|144275779|SUPERIORITY|||||||0.1323|||||||van Elteren stratified rank test|van Elteren stratified rank test adjusting for baseline use of glucocorticoid was used.||||||0.1323
72383766|NCT01973569|144275780|SUPERIORITY|||||||0.0448|||||||van Elteren stratified rank test|van Elteren stratified rank test adjusting for baseline use of glucocorticoid was used.||||||0.0448
72558126|NCT02997176|144645744|OTHER|Bioequivalence|Percent Ratio of Geometric Means|99.31|||||TWO_SIDED|90.0|57.74|170.8||||||Cmax was natural log-transformed and analyzed using an ANOVA model with hepatic function group as a fixed effect.||170.80|57.74|
72558127|NCT02997176|144645744|OTHER|Bioequivalence|Percent Ratio of Geometric Means|96.45|||||TWO_SIDED|90.0|52.22|178.14||||||Cmax was natural log-transformed and analyzed using an ANOVA model with hepatic function group as a fixed effect.||178.14|52.22|
72558128|NCT02997176|144645744|OTHER|Bioequivalence|Percent Ratio of Geometric Means|64.05|||||TWO_SIDED|90.0|39.65|103.46||||||Cmax was natural log-transformed and analyzed using ANOVA model with hepatic function group as a fixed effect.||103.46|39.65|
72558129|NCT02997176|144645747|OTHER|Bioequivalence|Percent Ratio of Geometric Means|118.47|||||TWO_SIDED|90.0|83.81|167.47||||||AUC0-24u was natural log-transformed and analyzed using ANOVA model with hepatic function group as a fixed effect.||167.47|83.81|
72558130|NCT02997176|144645747|OTHER|Bioequivalence|Percent Ratio of Geometric Means|108.36|||||TWO_SIDED|90.0|73.25|160.3||||||AUC0-24u was natural log-transformed and analyzed using ANOVA model with hepatic function group as a fixed effect.||160.30|73.25|
72558131|NCT02997176|144645747|OTHER|Bioequivalence|Percent Ratio of Geometric Means|117.84|||||TWO_SIDED|90.0|85.29|162.83||||||AUC0-24u was natural log-transformed and analyzed using ANOVA model with hepatic function group as a fixed effect.||162.83|85.29|
72558132|NCT02997176|144645748|OTHER|Bioequivalence|Percent Ratio of Geometric Means|94.58|||||TWO_SIDED|90.0|56.74|157.64||||||Cmaxu was natural log-transformed and analyzed using an ANOVA model with hepatic function group as a fixed effect.||157.64|56.74|
72558133|NCT02997176|144645748|OTHER|Bioequivalence|Percent Ratio of Geometric Means|92.15|||||TWO_SIDED|90.0|51.69|164.26||||||Cmaxu was natural log-transformed and analyzed using an ANOVA model with hepatic function group as a fixed effect.||164.26|51.69|
72558134|NCT02997176|144645748|OTHER|Bioequivalence|Percent Ratio of Geometric Means|84.42|||||TWO_SIDED|90.0|53.14|134.1||||||Cmaxu was natural log-transformed and analyzed using an ANOVA model with hepatic function group as a fixed effect.||134.10|53.14|
72383767|NCT01973569|144275781|SUPERIORITY|||||||0.0104|||||||van Elteren stratified rank test|van Elteren stratified rank test adjusting for baseline use of glucocorticoid was used.||||||0.0104
72383768|NCT01973569|144275782|SUPERIORITY|||||||0.257|||||||van Elteren stratified rank test|van Elteren stratified rank test adjusting for baseline use of glucocorticoid was used.||||||0.2570
72383769|NCT01973569|144275783|SUPERIORITY||Mean Difference (Net)|5.02|||<|0.0001|TWO_SIDED|95.0|4.41|5.63|||Regression, Cox|ANCOVA model adjusting for treatment, baseline (BL) value, machine type, BL value-by-machine type interaction, and BL use of glucocorticoid was used.||||5.63|4.41|<0.0001
72383770|NCT00810108|144275784|NON_INFERIORITY_OR_EQUIVALENCE|The geometric mean and 90% confidence interval assessed whether the crushed and whole tablet administration AUCs were equivalent.|Ratio of Crushed/Whole Tablet AUC|0.55|||<|0.05|TWO_SIDED|90.0|0.45|0.69|||t-test, 2 sided|||Lopinavir AUC was compared between whole tablet and crushed tablet administration by using a ratio of crushed/whole AUC.||0.69|0.45|<0.05
72383771|NCT00567593|144275898|SUPERIORITY_OR_OTHER|||||||0.01|||||||Wilcoxon (Mann-Whitney)|Wilcoxon Rank Sum test||||||.01
72383772|NCT01675427|144275922|SUPERIORITY_OR_OTHER|||||||0.0018|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three IL28B genotype categories|Cochran-Armitage Trend Test|||G1||||0.0018
72383773|NCT01675427|144275922|SUPERIORITY_OR_OTHER|||||||0.2289|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three IL28B genotype categories|Cochran-Armitage Trend Test|||G2||||0.2289
72383774|NCT01675427|144275922|SUPERIORITY_OR_OTHER|||||||0.1112|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three IL28B genotype categories|Cochran-Armitage Trend Test|||G3||||0.1112
72383775|NCT01675427|144275922|SUPERIORITY_OR_OTHER|||||||0.4681|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three IL28B genotype categories|Cochran-Armitage Trend Test|||G4||||0.4681
72383776|NCT01675427|144275922|SUPERIORITY_OR_OTHER|||||||0.4828|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three IL28B genotype categories|Cochran-Armitage Trend Test|||Other genotypes||||0.4828
72383777|NCT01675427|144275922|SUPERIORITY_OR_OTHER|||||||0.2702|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three IL28B genotype categories|Cochran-Armitage Trend Test|||Total genotypes||||0.2702
72383778|NCT01675427|144275923|SUPERIORITY_OR_OTHER|||||||0.4133|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three IL28B genotype categories|Cochran-Armitage Trend Test|||G1||||0.4133
72383779|NCT01675427|144275923|SUPERIORITY_OR_OTHER|||||||0.44|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three IL28B genotype categories|Cochran-Armitage Trend Test|||G2||||0.4400
72383780|NCT01675427|144275923|SUPERIORITY_OR_OTHER|||||||0.8597|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three IL28B genotype categories|Cochran-Armitage Trend Test|||G3||||0.8597
72383781|NCT01675427|144275923|SUPERIORITY_OR_OTHER|||||||0.3975|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three IL28B genotype categories|Cochran-Armitage Trend Test|||G4||||0.3975
72383782|NCT01675427|144275923|SUPERIORITY_OR_OTHER|||||||0.1781|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three IL28B genotype categories|Cochran-Armitage Trend Test|||Other genotypes||||0.1781
72383783|NCT01675427|144275923|SUPERIORITY_OR_OTHER|||||||0.3159|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three IL28B genotype categories|Cochran-Armitage Trend Test|||Total genotypes||||0.3159
72383784|NCT01675427|144275924|SUPERIORITY_OR_OTHER|||||||0.0126|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three IL28B genotype categories|Cochran-Armitage Trend Test|||G1||||0.0126
72383785|NCT01675427|144275924|SUPERIORITY_OR_OTHER|||||||0.7174|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three IL28B genotype categories|Cochran-Armitage Trend Test|||G2||||0.7174
72383786|NCT01675427|144275924|SUPERIORITY_OR_OTHER|||||||0.138|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three IL28B genotype categories|Cochran-Armitage Trend Test|||G3||||0.1380
72383787|NCT01675427|144275924|SUPERIORITY_OR_OTHER|||||||0.6258|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three IL28B genotype categories|Cochran-Armitage Trend Test|||G4||||0.6258
72558135|NCT00373256|144645771|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.6299||||0.9986|TWO_SIDED|95.0|1.1793|2.2527||p-value from 1-sided log-rank stratified for prior adjuvant chemotherapy, hormone receptor status, disease-free interval from prior adjuvant treatment. Stratification factors from Interactive Voice Randomization System.|Log Rank||Assuming proportional hazards, a hazard ratio greater than 1 indicated a reduction in hazard rate in favor Bevacizumab + Paclitaxel.|||2.2527|1.1793|0.9986
72558136|NCT00373256|144645772|SUPERIORITY_OR_OTHER||Objective Response Rate (ORR) (percent)|32.2|||||TWO_SIDED|95.0|26.4|38.5||||||||38.5|26.4|
72558137|NCT00373256|144645772|SUPERIORITY_OR_OTHER||Objective Response Rate (ORR) (percent)|32.1|||||TWO_SIDED|95.0|26.3|38.4||||||||38.4|26.3|
72558138|NCT00373256|144645775|SUPERIORITY_OR_OTHER||Percentage|76.8|||||TWO_SIDED|95.0|68.7|83.0||||||1 year||83.0|68.7|
72383788|NCT01675427|144275924|SUPERIORITY_OR_OTHER|||||||0.5751|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three IL28B genotype categories|Cochran-Armitage Trend Test|||Other genotypes||||0.5751
72383789|NCT01675427|144275924|SUPERIORITY_OR_OTHER|||||||0.1681|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three IL28B genotype categories|Cochran-Armitage Trend Test|||Total genotypes||||0.1681
72383790|NCT01675427|144275925|SUPERIORITY_OR_OTHER|||||||0.2693|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three IL28B genotype categories|Cochran-Armitage Trend Test|||G1||||0.2693
72383791|NCT01675427|144275925|SUPERIORITY_OR_OTHER|||||||0.324|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three IL28B genotype categories|Cochran-Armitage Trend Test|||G2||||0.3240
72383792|NCT01675427|144275925|SUPERIORITY_OR_OTHER|||||||0.7006|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three IL28B genotype categories|Cochran-Armitage Trend Test|||G3||||0.7006
72383793|NCT01675427|144275925|SUPERIORITY_OR_OTHER|||||||0.0403|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three IL28B genotype categories|Cochran-Armitage Trend Test|||G4||||0.0403
72383794|NCT01675427|144275925|SUPERIORITY_OR_OTHER|||||||0.1075|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three IL28B genotype categories|Cochran-Armitage Trend Test|||Other genotypes||||0.1075
72383795|NCT01675427|144275925|SUPERIORITY_OR_OTHER|||||||0.3295|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three IL28B genotype categories|Cochran-Armitage Trend Test|||Total genotypes||||0.3295
72383796|NCT01675427|144275926|SUPERIORITY_OR_OTHER|||||||0.9859|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G1||||0.9859
72383797|NCT01675427|144275926|SUPERIORITY_OR_OTHER|||||||0.7055|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G2||||0.7055
72383798|NCT01675427|144275926|SUPERIORITY_OR_OTHER|||||||0.092|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G3||||0.0920
72383799|NCT01675427|144275926|SUPERIORITY_OR_OTHER|||||||0.0781|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G4||||0.0781
72435668|NCT01460342|144384381|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The p-value was from the Cochran-Mantel-Haenszel test adjusted for baseline severity of benign prostatic hyperplasia lower urinary tract symptoms (BPH-LUTS) and previous alpha-blocker therapy.|Cochran-Mantel-Haenszel|||||||<0.001
72558139|NCT00373256|144645775|SUPERIORITY_OR_OTHER||Percentage|35.5|||||TWO_SIDED|95.0|20.9|50.3||||||2 years||50.3|20.9|
72383800|NCT01675427|144275926|SUPERIORITY_OR_OTHER|||||||0.4795|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Other genotypes||||0.4795
72383801|NCT01675427|144275926|SUPERIORITY_OR_OTHER|||||||0.3069|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Total genotypes||||0.3069
72383802|NCT01675427|144275927|SUPERIORITY_OR_OTHER|||||||0.5216|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G1||||0.5216
72383803|NCT01675427|144275927|SUPERIORITY_OR_OTHER|||||||0.3419|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G2||||0.3419
72383804|NCT01675427|144275927|SUPERIORITY_OR_OTHER|||||||0.7586|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G3||||0.7586
72383805|NCT01675427|144275927|SUPERIORITY_OR_OTHER|||||||0.1351|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G4||||0.1351
72383806|NCT01675427|144275927|SUPERIORITY_OR_OTHER|||||||0.2386|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Other genotypes||||0.2386
72383807|NCT01675427|144275927|SUPERIORITY_OR_OTHER|||||||0.3921|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Total genotypes||||0.3921
72383808|NCT01675427|144275928|SUPERIORITY_OR_OTHER|||||||0.8537|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G1||||0.8537
72383809|NCT01675427|144275928|SUPERIORITY_OR_OTHER|||||||0.0763|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G2||||0.0763
72383810|NCT01675427|144275928|SUPERIORITY_OR_OTHER|||||||0.2432|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G3||||0.2432
72383811|NCT01675427|144275928|SUPERIORITY_OR_OTHER|||||||0.4247|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G4||||0.4247
72435669|NCT01460342|144384382|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.3||0.06|TWO_SIDED|95.0|-1.2|0.0|||ANCOVA|||||0.0|-1.2|0.060
72558140|NCT00373256|144645775|SUPERIORITY_OR_OTHER||Percentage|83.7|||||TWO_SIDED|95.0|76.0|89.1||||||1 year||89.1|76.0|
72558141|NCT00373256|144645775|SUPERIORITY_OR_OTHER||Percentage|61.0|||||TWO_SIDED|95.0|43.2|74.7||||||2 years||74.7|43.2|
72435670|NCT01689519|144384383|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.51||||0.0001|TWO_SIDED|95.0|0.39|0.68||The analysis was stratified by geographic region and metastasis classification (disease stage).|Log Rank|||Primary Analysis 9 May 2014||0.68|0.39|0.0001
72435671|NCT01689519|144384383|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.58|||<|0.0001|TWO_SIDED|95.0|0.46|0.72||The analysis was stratified by geographic region and metastasis classification (disease stage).|Log Rank|||Post hoc Efficacy Analysis: 16 January 2015||0.72|0.46|<0.0001
72435672|NCT01689519|144384383|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.65|||<|0.0001|TWO_SIDED|95.0|0.53|0.79||The analysis was stratified by geographic region and metastasis classification (disease stage).|Log Rank|||Extended 5-Year Analysis: 21 July 2019||0.79|0.53|<0.0001
72435673|NCT01689519|144384384|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.645||||0.0463|TWO_SIDED|95.0|0.42|1.0||The analysis was stratified by geographic region and metastasis classification (disease stage).|Log Rank|||Primary Analysis 9 May 2014||1.00|0.42|0.0463
72435674|NCT01689519|144384384|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.65||||0.0034|TWO_SIDED|95.0|0.49|0.87||The analysis was stratified by geographic region and metastasis classification (disease stage).|Log Rank|||Post hoc Analysis 16 January 2015||0.87|0.49|0.0034
72435675|NCT01689519|144384384|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.7||||0.005|TWO_SIDED|95.0|0.55|0.9||The analysis was stratified by geographic region and metastasis classification (disease stage).|Log Rank|||Final Analysis 28 August 2015||0.90|0.55|0.0050
72435676|NCT01689519|144384385|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|22.85|||<|0.0001|TWO_SIDED|95.0|14.13|31.58|||Chi-squared|||Primary Analysis: 9 May 2014||31.58|14.13|<0.0001
72435677|NCT01689519|144384385|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|19.6|||<|0.0001|TWO_SIDED|95.0|11.0|28.3|||Chi-squared|||Post hoc Efficacy Analysis: 16 January 2015||28.3|11.0|<0.0001
72435678|NCT01689519|144384385|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|20.0|||<|0.0001|TWO_SIDED|95.0|11.4|28.7|||Chi-squared|||Extended 5-Year Analysis: 21 July 2019||28.70|11.40|<0.0001
72435679|NCT05046132|144384399|OTHER||Mean of Placebo-corrected CHFB|3.7|STANDARD_ERROR_OF_MEAN|1.48|||TWO_SIDED|90.0|1.23|6.17||||||"The C-QTc analysis was performed with a non-linear model.~The mean of placebo-corrected CHFB in QTcF at maximum concentration (Cmax) geometric mean of therapeutic dose (3 mg QD) was estimated with bias-corrected 90% CI by nonparametric bootstrap methods."||6.17|1.23|
72494336|NCT01703858|144517598|NON_INFERIORITY_OR_EQUIVALENCE|Assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMeans) with acceptance range of 80.00 to 125.00%|Ratio of Geometric means (%)|94.88|STANDARD_DEVIATION|43.2||0.1449|TWO_SIDED|90.0|72.175|124.731|||ANOVA|Relative bioavailability was estimated by the ratios of the adjusted geometric means. CIs were calculated based on the residual error.|Analysis of variance includes the effects: sequence, subjects nested within sequences, period and treatment in crossover; subject and treatment in fixed sequence. Standard deviation is actually Intra individual geometric coefficient of variation.|E : BI-113608 vs. B : BI-113608 - Food effect||124.731|72.175|0.1449
72504611|NCT02858193|144540038|EQUIVALENCE|Acceptance criterion for bioequivalence was that 94.12% confidence intervals (CIs) of the T/R ratios of the geometric means of the analysed PK parameters were within the 80.00-125.00% range according to the current guidelines for bioequivalence studies.|Geometric means ratio|111.63||||0.0482|TWO_SIDED|94.12|100.51|123.99||"treatment p-value reported"|ANOVA||Estimated value and limits are expressed in %|||123.99|100.51|0.0482
72435680|NCT05046132|144384400|OTHER||Mean of Placebo-corrected CHFB|4.67|||||TWO_SIDED|90.0|1.7|7.64||||||The C-QTc analysis was performed with a non-linear model. The mean of placebo-corrected CHFB in QTcF at Cmax geometric mean of therapeutic dose (7 mg QD) was estimated with bias-corrected 90% CI by nonparametric bootstrap methods.||7.64|1.70|
72435681|NCT05046132|144384401|OTHER||LS Mean|2.5|||||TWO_SIDED|90.0|-0.6|5.6||||||Pre-dose||5.6|-0.6|
72435682|NCT05046132|144384401|OTHER||LS Mean|0.1|||||TWO_SIDED|90.0|-3.0|3.1||||||0.5 hr Post dose||3.1|-3.0|
72435683|NCT05046132|144384401|OTHER||LS Mean|0.1|||||TWO_SIDED|90.0|-2.8|3.0||||||1 hr Post dose||3.0|-2.8|
72435684|NCT05046132|144384401|OTHER||LS Mean|1.6|||||TWO_SIDED|90.0|-1.8|5.1||||||1.5 hr Post dose||5.1|-1.8|
72435685|NCT05046132|144384401|OTHER||LS Mean|0.7|||||TWO_SIDED|90.0|-2.8|4.1||||||2 hr Post dose||4.1|-2.8|
72435686|NCT05046132|144384401|OTHER||LS Mean|0.2|||||TWO_SIDED|90.0|-2.9|3.4||||||2.5 hr Post dose||3.4|-2.9|
72435687|NCT05046132|144384401|OTHER||LS Mean|2.2|||||TWO_SIDED|90.0|-1.4|5.7||||||3 hr Post dose||5.7|-1.4|
72435688|NCT05046132|144384401|OTHER||LS Mean|-0.1|||||TWO_SIDED|90.0|-2.9|2.7||||||4 hr Post dose||2.7|-2.9|
72435689|NCT05046132|144384401|OTHER||LS Mean|-0.2|||||TWO_SIDED|90.0|-3.1|2.7||||||5 hr Post dose||2.7|-3.1|
72435690|NCT05046132|144384401|OTHER||LS Mean|-0.8|||||TWO_SIDED|90.0|-3.8|2.3||||||6 hr Post dose||2.3|-3.8|
72435691|NCT05046132|144384401|OTHER||LS Mean|-2.8|||||TWO_SIDED|90.0|-5.5|-0.1||||||7 hr Post dose||-0.1|-5.5|
72435692|NCT05046132|144384401|OTHER||LS Mean|-1.6|||||TWO_SIDED|90.0|-4.5|1.3||||||8 hr Post dose||1.3|-4.5|
72435693|NCT05046132|144384401|OTHER||LS Mean|0.3|||||TWO_SIDED|90.0|-2.5|3.0||||||9 hr Post dose||3.0|-2.5|
72435694|NCT05046132|144384401|OTHER||LS Mean|0.2|||||TWO_SIDED|90.0|-2.3|2.7||||||10 hr Post dose||2.7|-2.3|
72435695|NCT05046132|144384401|OTHER||LS Mean|-3.0|||||TWO_SIDED|90.0|-5.9|-0.1||||||12 hr Post dose||-0.1|-5.9|
72435696|NCT05046132|144384401|OTHER||LS Mean|-2.0|||||TWO_SIDED|90.0|-5.1|1.0||||||16 hr Post dose||1.0|-5.1|
72435697|NCT05046132|144384401|OTHER||LS Mean|1.1|||||TWO_SIDED|90.0|-1.6|3.8||||||24 hr Post dose||3.8|-1.6|
72435698|NCT05046132|144384401|OTHER||LS Mean|1.4|||||TWO_SIDED|90.0|-1.7|4.5||||||Pre-dose||4.5|-1.7|
72435699|NCT05046132|144384401|OTHER||LS Mean|1.7|||||TWO_SIDED|90.0|-1.4|4.7||||||0.5 hr Post dose||4.7|-1.4|
72435700|NCT05046132|144384401|OTHER||LS Mean|1.9|||||TWO_SIDED|90.0|-1.0|4.8||||||1 hr Post dose||4.8|-1.0|
72435701|NCT05046132|144384401|OTHER||LS Mean|2.6|||||TWO_SIDED|90.0|-0.9|6.0||||||1.5 hr Post dose||6.0|-0.9|
72435702|NCT05046132|144384401|OTHER||LS Mean|1.3|||||TWO_SIDED|90.0|-2.1|4.8||||||2 hr Post dose||4.8|-2.1|
72435703|NCT05046132|144384401|OTHER||LS Mean|1.7|||||TWO_SIDED|90.0|-1.4|4.9||||||2.5 hr Post dose||4.9|-1.4|
72435704|NCT05046132|144384401|OTHER||LS Mean|1.6|||||TWO_SIDED|90.0|-1.9|5.1||||||3 hr Post dose||5.1|-1.9|
72435705|NCT05046132|144384401|OTHER||LS Mean|1.4|||||TWO_SIDED|90.0|-1.4|4.2||||||4 hr Post dose||4.2|-1.4|
72435706|NCT05046132|144384401|OTHER||LS Mean|2.7|||||TWO_SIDED|90.0|-0.2|5.7||||||5 hr Post dose||5.7|-0.2|
72435707|NCT05046132|144384401|OTHER||LS Mean|4.4|||||TWO_SIDED|90.0|1.4|7.5||||||6 hr Post dose||7.5|1.4|
72435708|NCT05046132|144384401|OTHER||LS Mean|2.8|||||TWO_SIDED|90.0|0.1|5.5||||||7 hr Post dose||5.5|0.1|
72435709|NCT05046132|144384401|OTHER||LS Mean|4.1|||||TWO_SIDED|90.0|1.2|7.0||||||8 hr Post dose||7.0|1.2|
72435710|NCT05046132|144384401|OTHER||LS Mean|3.6|||||TWO_SIDED|90.0|0.8|6.3||||||9 hr Post dose||6.3|0.8|
72435711|NCT05046132|144384401|OTHER||LS Mean|3.3|||||TWO_SIDED|90.0|0.8|5.8||||||10 hr Post dose||5.8|0.8|
72435712|NCT05046132|144384401|OTHER||LS Mean|2.6|||||TWO_SIDED|90.0|-0.3|5.5||||||12 hr Post dose||5.5|-0.3|
72435713|NCT05046132|144384401|OTHER||LS Mean|0.3|||||TWO_SIDED|90.0|-2.7|3.4||||||16 hr Post dose||3.4|-2.7|
72494337|NCT01703858|144517598|NON_INFERIORITY_OR_EQUIVALENCE|Assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMeans) with acceptance range of 80.00 to 125.00%|Ratio of Geometric means (%)|169.46|STANDARD_DEVIATION|49.7||0.9463|TWO_SIDED|90.0|124.093|231.419|||ANOVA|Relative bioavailability was estimated by the ratios of the adjusted geometric means. CIs were calculated based on the residual error.|Analysis of variance includes the effects: sequence, subjects nested within sequences, period and treatment in crossover; subject and treatment in fixed sequence. Standard deviation is actually Intra individual geometric coefficient of variation.|E : BI-113608 vs. C : BI-113608 - Food effect||231.419|124.093|0.9463
72494338|NCT01703858|144517598|NON_INFERIORITY_OR_EQUIVALENCE|Assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMeans) with acceptance range of 80.00 to 125.00%|Ratio of Geometric means (%)|81.06|STANDARD_DEVIATION|33.3||0.4564|TWO_SIDED|90.0|65.811|99.848|||ANOVA|Relative bioavailability was estimated by the ratios of the adjusted geometric means. CIs were calculated based on the residual error.|Analysis of variance includes the effects: sequence, subjects nested within sequences, period and treatment in crossover; subject and treatment in fixed sequence. Standard deviation is actually Intra individual geometric coefficient of variation.|D : BI-113608 vs. B : BI-113608 - Pantoprazole effect||99.848|65.811|0.4564
72494339|NCT01703858|144517599|NON_INFERIORITY_OR_EQUIVALENCE|Assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMeans) with acceptance range of 80.00 to 125.00%|Ratio of Geometric means (%)|98.66|STANDARD_DEVIATION|9.9||0|TWO_SIDED|90.0|92.5|105.225|||ANOVA|Relative bioavailability was estimated by the ratios of the adjusted geometric means. CIs were calculated based on the residual error.|Analysis of variance includes the effects: sequence, subjects nested within sequences, period and treatment in crossover; subject and treatment in fixed sequence. Standard deviation is actually Intra individual geometric coefficient of variation.|B : BI-113608 vs. A : BI-113608 - Comparison with oral solution||105.225|92.500|0.0000
72504612|NCT02858193|144540040|EQUIVALENCE|Acceptance criterion for bioequivalence was that 94.12% confidence intervals (CIs) of the T/R ratios of the geometric means of the analysed PK parameters were within the 80.00-125.00% range according to the current guidelines for bioequivalence studies|geometric means ratio|109.41||||0.0002|TWO_SIDED|94.12|104.93|114.07||"treatment p-value is reported"|ANOVA||Estimated value and limits are expressed in%|||114.07|104.93|0.0002
72435714|NCT05046132|144384401|OTHER||LS Mean|1.7|||||TWO_SIDED|90.0|-1.0|4.4||||||24 hr Post dose||4.4|-1.0|
72435715|NCT05046132|144384402|OTHER||LS Mean|0.3|||||TWO_SIDED|90.0|-2.8|3.4||||||Pre dose||3.4|-2.8|
72435716|NCT05046132|144384402|OTHER||LS Mean|-2.1|||||TWO_SIDED|90.0|-5.3|1.0||||||0.5 hr Post dose||1.0|-5.3|
72435717|NCT05046132|144384402|OTHER||LS Mean|-1.6|||||TWO_SIDED|90.0|-4.7|1.4||||||1 hr Post dose||1.4|-4.7|
72435718|NCT05046132|144384402|OTHER||LS Mean|-2.2|||||TWO_SIDED|90.0|-5.3|1.0||||||1.5 hr Post dose||1.0|-5.3|
72435719|NCT05046132|144384402|OTHER||LS Mean|-3.3|||||TWO_SIDED|90.0|-6.3|-0.3||||||2 hr Post dose||-0.3|-6.3|
72435720|NCT05046132|144384402|OTHER||LS Mean|-1.2|||||TWO_SIDED|90.0|-4.1|1.7||||||2.5 hr Post dose||1.7|-4.1|
72435721|NCT05046132|144384402|OTHER||LS Mean|-1.3|||||TWO_SIDED|90.0|-4.2|1.7||||||3 hr Post dose||1.7|-4.2|
72435722|NCT05046132|144384402|OTHER||LS Mean|-0.6|||||TWO_SIDED|90.0|-3.6|2.5||||||4 hr Post dose||2.5|-3.6|
72435723|NCT05046132|144384402|OTHER||LS Mean|-1.0|||||TWO_SIDED|95.0|-4.1|2.1||||||5 hr Post dose||2.1|-4.1|
72435724|NCT05046132|144384402|OTHER||LS Mean|0.4|||||TWO_SIDED|90.0|-2.7|3.5||||||6 hr Post dose||3.5|-2.7|
72435725|NCT05046132|144384402|OTHER||LS Mean|-2.5|||||TWO_SIDED|90.0|-5.5|0.5||||||7 hr Post dose||0.5|-5.5|
72435726|NCT05046132|144384402|OTHER||LS Mean|-2.2|||||TWO_SIDED|90.0|-5.2|0.8||||||8 hr Post dose||0.8|-5.2|
72435727|NCT05046132|144384402|OTHER||LS Mean|-0.9|||||TWO_SIDED|90.0|-4.3|2.6||||||9 hr Post dose||2.6|-4.3|
72435728|NCT05046132|144384402|OTHER||LS Mean|-0.2|||||TWO_SIDED|90.0|-3.6|3.2||||||10 hr Post dose||3.2|-3.6|
72435729|NCT05046132|144384402|OTHER||LS Mean|-2.2|||||TWO_SIDED|90.0|-5.5|1.0||||||12 hr Post dose||1.0|-5.5|
72435730|NCT05046132|144384402|OTHER||LS Mean|-1.9|||||TWO_SIDED|90.0|-5.4|1.7||||||16 hr Post dose||1.7|-5.4|
72435731|NCT05046132|144384402|OTHER||LS Mean|2.6|||||TWO_SIDED|90.0|-1.2|6.3||||||24 hr Post dose||6.3|-1.2|
72435732|NCT05046132|144384402|OTHER||LS Mean|-2.1|||||TWO_SIDED|90.0|-5.1|0.8||||||Pre-dose||0.8|-5.1|
72435733|NCT05046132|144384402|OTHER||LS Mean|-0.1|||||TWO_SIDED|90.0|-3.1|3.0||||||0.5 hr Post dose||3.0|-3.1|
72435734|NCT05046132|144384402|OTHER||LS Mean|-0.1|||||TWO_SIDED|90.0|-3.0|2.9||||||1 hr Post dose||2.9|-3.0|
72435735|NCT05046132|144384402|OTHER||LS Mean|-0.1|||||TWO_SIDED|90.0|-3.1|3.0||||||1.5 hr Post dose||3.0|-3.1|
72435736|NCT05046132|144384402|OTHER||LS Mean|-0.9|||||TWO_SIDED|90.0|-3.8|2.0||||||2 hr Post dose||2.0|-3.8|
72435737|NCT05046132|144384402|OTHER||LS Mean|0.2|||||TWO_SIDED|90.0|-2.5|3.0||||||2.5 hr Post dose||3.0|-2.5|
72435738|NCT05046132|144384402|OTHER||LS Mean|0.9|||||TWO_SIDED|90.0|-1.9|3.7||||||3 hr Post dose||3.7|-1.9|
72435739|NCT05046132|144384402|OTHER||LS Mean|0.7|||||TWO_SIDED|90.0|-2.2|3.7||||||4 hr Post dose||3.7|-2.2|
72435740|NCT05046132|144384402|OTHER||LS Mean|0.1|||||TWO_SIDED|90.0|-2.8|3.1||||||5 hr Post dose||3.1|-2.8|
72435741|NCT05046132|144384402|OTHER||LS Mean|-0.9|||||TWO_SIDED|90.0|-3.9|2.0||||||6 hr Post dose||2.0|-3.9|
72435742|NCT05046132|144384402|OTHER||LS Mean|-0.2|||||TWO_SIDED|90.0|-3.1|2.7||||||7 hr Post dose||2.7|-3.1|
72435743|NCT05046132|144384402|OTHER||LS Mean|0.2|||||TWO_SIDED|90.0|-2.7|3.1||||||8 hr Post dose||3.1|-2.7|
72435744|NCT05046132|144384402|OTHER||LS Mean|0.7|||||TWO_SIDED|90.0|-2.7|4.0||||||9 hr Post dose||4.0|-2.7|
72435745|NCT05046132|144384402|OTHER||LS Mean|0.9|||||TWO_SIDED|90.0|-2.3|4.1||||||10 hr Post dose||4.1|-2.3|
72435746|NCT05046132|144384402|OTHER||LS Mean|-0.4|||||TWO_SIDED|90.0|-3.5|2.8||||||12 hr Post dose||2.8|-3.5|
72435747|NCT05046132|144384402|OTHER||LS Mean|-0.4|||||TWO_SIDED|90.0|-3.8|3.0||||||16 hr Post dose||3.0|-3.8|
72435748|NCT05046132|144384402|OTHER||LS Mean|-1.6|||||TWO_SIDED|90.0|-5.1|2.0||||||24 hr Post dose||2.0|-5.1|
72435749|NCT05046132|144384403|OTHER||LS Mean|3.5|||||TWO_SIDED|90.0|0.1|6.8||||||Pre dose||6.8|0.1|
72435750|NCT05046132|144384403|OTHER||LS Mean|0.8|||||TWO_SIDED|90.0|-3.0|4.6||||||0.5 hr Post dose||4.6|-3.0|
72435751|NCT05046132|144384403|OTHER||LS Mean|-0.1|||||TWO_SIDED|90.0|-4.1|3.9||||||1 hr Post dose||3.9|-4.1|
72435752|NCT05046132|144384403|OTHER||LS Mean|0.9|||||TWO_SIDED|90.0|-2.7|4.4||||||1.5 hr Post dose||4.4|-2.7|
72435753|NCT05046132|144384403|OTHER||LS Mean|3.0|||||TWO_SIDED|90.0|-0.6|6.6||||||2 hr Post dose||6.6|-0.6|
72435754|NCT05046132|144384403|OTHER||LS Mean|3.5|||||TWO_SIDED|90.0|-0.3|7.4||||||2.5 hr Post dose||7.4|-0.3|
72435755|NCT05046132|144384403|OTHER||LS Mean|4.6|||||TWO_SIDED|90.0|1.2|8.1||||||3 hr Post dose||8.1|1.2|
72435756|NCT05046132|144384403|OTHER||LS Mean|5.2|||||TWO_SIDED|90.0|1.5|8.9||||||4 hr Post dose||8.9|1.5|
72435757|NCT05046132|144384403|OTHER||LS Mean|2.0|||||TWO_SIDED|90.0|-1.7|5.8||||||5 hr Post dose||5.8|-1.7|
72435758|NCT05046132|144384403|OTHER||LS Mean|1.7|||||TWO_SIDED|90.0|-1.6|5.1||||||6 hr Post dose||5.1|-1.6|
72435759|NCT05046132|144384403|OTHER||LS Mean|2.3|||||TWO_SIDED|90.0|-1.1|5.7||||||7 hr Post dose||5.7|-1.1|
72558142|NCT02727192|144645793|SUPERIORITY||Mean Difference (Net)|-0.6||||0.52|TWO_SIDED|95.0|-2.6|1.3||A two-sided significance level of 5% was considered to indicate statistical significance.|Regression, Linear|||||1.3|-2.6|0.520
72435760|NCT05046132|144384403|OTHER||LS Mean|2.4|||||TWO_SIDED|90.0|-1.4|6.2||||||8 hr Post dose||6.2|-1.4|
72435761|NCT05046132|144384403|OTHER||LS Mean|4.4|||||TWO_SIDED|90.0|0.9|7.8||||||9 hr Post dose||7.8|0.9|
72435762|NCT05046132|144384403|OTHER||LS Mean|3.8|||||TWO_SIDED|90.0|0.3|7.4||||||10 hr Post dose||7.4|0.3|
72435763|NCT05046132|144384403|OTHER||LS Mean|-0.8|||||TWO_SIDED|90.0|-4.2|2.7||||||12 hr Post dose||2.7|-4.2|
72435764|NCT05046132|144384403|OTHER||LS Mean|3.6|||||TWO_SIDED|90.0|0.1|7.0||||||16 hr Post dose||7.0|0.1|
72435765|NCT05046132|144384403|OTHER||LS Mean|-1.5|||||TWO_SIDED|90.0|-5.7|2.8||||||24 hr Post dose||2.8|-5.7|
72435766|NCT05046132|144384403|OTHER||LS Mean|2.3|||||TWO_SIDED|90.0|-1.0|5.6||||||Pre dose||5.6|-1.0|
72435767|NCT05046132|144384403|OTHER||LS Mean|-1.6|||||TWO_SIDED|90.0|-5.4|2.2||||||0.5 hr Post dose||2.2|-5.4|
72435768|NCT05046132|144384403|OTHER||LS Mean|0.3|||||TWO_SIDED|90.0|-3.8|4.3||||||1 hr Post dose||4.3|-3.8|
72435769|NCT05046132|144384403|OTHER||LS Mean|4.0|||||TWO_SIDED|90.0|0.4|7.6||||||1.5 hr Post dose||7.6|0.4|
72435770|NCT05046132|144384403|OTHER||LS Mean|6.3|||||TWO_SIDED|90.0|2.7|10.0||||||2 hr Post dose||10.0|2.7|
72435771|NCT05046132|144384403|OTHER||LS Mean|6.4|||||TWO_SIDED|90.0|2.6|10.2||||||2.5 hr Post dose||10.2|2.6|
72435772|NCT05046132|144384403|OTHER||LS Mean|8.5|||||TWO_SIDED|90.0|5.0|12.0||||||3 hr Post dose||12.0|5.0|
72435773|NCT05046132|144384403|OTHER||LS Mean|10.1|||||TWO_SIDED|90.0|6.4|13.8||||||4 hr Post dose||13.8|6.4|
72435774|NCT05046132|144384403|OTHER||LS Mean|7.8|||||TWO_SIDED|90.0|4.1|11.6||||||5 hr Post dose||11.6|4.1|
72435775|NCT05046132|144384403|OTHER||LS Mean|7.8|||||TWO_SIDED|90.0|4.4|11.2||||||6 hr Post dose||11.2|4.4|
72435776|NCT05046132|144384403|OTHER||LS Mean|6.8|||||TWO_SIDED|90.0|3.4|10.2||||||7 hr Post dose||10.2|3.4|
72435777|NCT05046132|144384403|OTHER||LS Mean|4.5|||||TWO_SIDED|90.0|0.6|8.3||||||8 hr Post dose||8.3|0.6|
72435778|NCT05046132|144384403|OTHER||LS Mean|6.5|||||TWO_SIDED|90.0|3.1|10.0||||||9 hr Post dose||10.0|3.1|
72435779|NCT05046132|144384403|OTHER||LS Mean|6.6|||||TWO_SIDED|90.0|3.0|10.1||||||10 hr Post dose||10.1|3.0|
72435780|NCT05046132|144384403|OTHER||LS Mean|5.3|||||TWO_SIDED|90.0|1.8|8.8||||||12 hr Post dose||8.8|1.8|
72435781|NCT05046132|144384403|OTHER||LS Mean|7.2|||||TWO_SIDED|90.0|3.7|10.6||||||16 hr Post dose||10.6|3.7|
72435782|NCT05046132|144384403|OTHER||LS Mean|3.3|||||TWO_SIDED|90.0|-1.0|7.5||||||24 hr Post dose||7.5|-1.0|
72435783|NCT05046132|144384404|OTHER||LS Mean|7.8|||||TWO_SIDED|90.0|3.7|11.8||||||Pre dose||11.8|3.7|
72435784|NCT05046132|144384404|OTHER||LS Mean|6.5|||||TWO_SIDED|90.0|3.3|9.8||||||0.5 hr Post dose||9.8|3.3|
72558143|NCT02727192|144645794|SUPERIORITY||Mean Difference (Net)|-0.9||||0.44|TWO_SIDED|95.0|-3.3|1.5|||Regression, Linear|||||1.5|-3.3|0.440
72435785|NCT05046132|144384404|OTHER||LS Mean|4.6|||||TWO_SIDED|90.0|0.6|8.6||||||1 hr Post dose||8.6|0.6|
72435786|NCT05046132|144384404|OTHER||LS Mean|4.6|||||TWO_SIDED|90.0|0.6|8.6||||||1.5 hr Post dose||8.6|0.6|
72435787|NCT05046132|144384404|OTHER||LS Mean|3.8|||||TWO_SIDED|90.0|-0.4|8.0||||||2 hr Post dose||8.0|-0.4|
72435788|NCT05046132|144384404|OTHER||LS Mean|6.1|||||TWO_SIDED|90.0|1.8|10.4||||||2.5 hr Post dose||10.4|1.8|
72435789|NCT05046132|144384404|OTHER||LS Mean|5.7|||||TWO_SIDED|90.0|1.7|9.8||||||3 hr Post dose||9.8|1.7|
72435790|NCT05046132|144384404|OTHER||LS Mean|6.2|||||TWO_SIDED|90.0|2.5|9.8||||||4 hr Post dose||9.8|2.5|
72435791|NCT05046132|144384404|OTHER||LS Mean|5.7|||||TWO_SIDED|90.0|1.6|9.8||||||5 hr Post dose||9.8|1.6|
72435792|NCT05046132|144384404|OTHER||LS Mean|4.8|||||TWO_SIDED|90.0|1.1|8.4||||||6 hr Post dose||8.4|1.1|
72435793|NCT05046132|144384404|OTHER||LS Mean|3.0|||||TWO_SIDED|90.0|-0.9|7.0||||||7 hr Post dose||7.0|-0.9|
72435794|NCT05046132|144384404|OTHER||LS Mean|5.0|||||TWO_SIDED|90.0|1.3|8.8||||||8 hr Post dose||8.8|1.3|
72435795|NCT05046132|144384404|OTHER||LS Mean|6.5|||||TWO_SIDED|90.0|2.5|10.6||||||9 hr Post dose||10.6|2.5|
72435796|NCT05046132|144384404|OTHER||LS Mean|8.6|||||TWO_SIDED|90.0|4.8|12.3||||||10 hr Post dose||12.3|4.8|
72435797|NCT05046132|144384404|OTHER||LS Mean|7.9|||||TWO_SIDED|90.0|4.4|11.4||||||12 hr Post dose||11.4|4.4|
72435798|NCT05046132|144384404|OTHER||LS Mean|4.9|||||TWO_SIDED|90.0|0.9|8.9||||||16 hr Post dose||8.9|0.9|
72435799|NCT05046132|144384404|OTHER||LS Mean|7.8|||||TWO_SIDED|90.0|3.6|12.0||||||24 hr Post dose||12.0|3.6|
72435800|NCT05046132|144384404|OTHER||LS Mean|2.1|||||TWO_SIDED|90.0|-1.8|6.0||||||Pre dose||6.0|-1.8|
72435801|NCT05046132|144384404|OTHER||LS Mean|3.1|||||TWO_SIDED|90.0|0.0|6.2||||||0.5 hr Post dose||6.2|-0.0|
72435802|NCT05046132|144384404|OTHER||LS Mean|1.9|||||TWO_SIDED|90.0|-1.9|5.7||||||1 hr Post dose||5.7|-1.9|
72435803|NCT05046132|144384404|OTHER||LS Mean|6.5|||||TWO_SIDED|90.0|2.6|10.4||||||1.5 hr Post dose||10.4|2.6|
72435804|NCT05046132|144384404|OTHER||LS Mean|5.3|||||TWO_SIDED|90.0|1.3|9.3||||||2 hr Post dose||9.3|1.3|
72435805|NCT05046132|144384404|OTHER||LS Mean|11.1|||||TWO_SIDED|90.0|7.0|15.1||||||2.5 hr Post dose||15.1|7.0|
72435806|NCT05046132|144384404|OTHER||LS Mean|9.8|||||TWO_SIDED|90.0|5.9|13.6||||||3 hr Post dose||13.6|5.9|
72435807|NCT05046132|144384404|OTHER||LS Mean|10.7|||||TWO_SIDED|90.0|7.2|14.2||||||4 hr Post dose||14.2|7.2|
72435808|NCT05046132|144384404|OTHER||LS Mean|8.8|||||TWO_SIDED|90.0|4.9|12.7||||||5 hr Post dose||12.7|4.9|
72435809|NCT05046132|144384404|OTHER||LS Mean|11.0|||||TWO_SIDED|90.0|7.5|14.5||||||6 hr Post dose||14.5|7.5|
72435810|NCT05046132|144384404|OTHER||LS Mean|10.8|||||TWO_SIDED|90.0|7.1|14.6||||||7 hr Post dose||14.6|7.1|
72435811|NCT05046132|144384404|OTHER||LS Mean|11.3|||||TWO_SIDED|90.0|7.6|14.9||||||8 hr Post dose||14.9|7.6|
72435812|NCT05046132|144384404|OTHER||LS Mean|9.8|||||TWO_SIDED|90.0|5.9|13.7||||||9 hr Post dose||13.7|5.9|
72435813|NCT05046132|144384404|OTHER||LS Mean|10.5|||||TWO_SIDED|90.0|6.9|14.1||||||10 hr Post dose||14.1|6.9|
72435814|NCT05046132|144384404|OTHER||LS Mean|11.8|||||TWO_SIDED|90.0|8.4|15.2||||||12 hr Post dose||15.2|8.4|
72435815|NCT05046132|144384404|OTHER||LS Mean|9.4|||||TWO_SIDED|90.0|5.6|13.3||||||16 hr Post dose||13.3|5.6|
72494340|NCT01703858|144517599|NON_INFERIORITY_OR_EQUIVALENCE|Assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMeans) with acceptance range of 80.00 to 125.00%|Ratio of Geometric means (%)|70.24|STANDARD_DEVIATION|18.3||0.9635|TWO_SIDED|90.0|62.43|79.038|||ANOVA|Relative bioavailability was estimated by the ratios of the adjusted geometric means. CIs were calculated based on the residual error.|Analysis of variance includes the effects: sequence, subjects nested within sequences, period and treatment in crossover; subject and treatment in fixed sequence. Standard deviation is actually Intra individual geometric coefficient of variation.|C : BI-113608 vs. B : BI-113608 - Food effect||79.038|62.430|0.9635
72558144|NCT02727192|144645795|SUPERIORITY||Mean Difference (Net)|-0.6||||0.41|TWO_SIDED|95.0|-2.1|0.9|||Regression, Linear|||||0.9|-2.1|0.410
72435816|NCT05046132|144384404|OTHER||LS Mean|10.8|||||TWO_SIDED|90.0|6.8|14.9||||||24 hr Post dose||14.9|6.8|
72435817|NCT05046132|144384405|OTHER||LS Mean|-5.3|||||TWO_SIDED|90.0|-8.4|-2.2||||||Pre dose||-2.2|-8.4|
72435818|NCT05046132|144384405|OTHER||LS Mean|-2.7|||||TWO_SIDED|90.0|-5.9|0.5||||||0.5 hr Post dose||0.5|-5.9|
72435819|NCT05046132|144384405|OTHER||LS Mean|-3.2|||||TWO_SIDED|90.0|-5.7|-0.7||||||1 hr Post dose||-0.7|-5.7|
72435820|NCT05046132|144384405|OTHER||LS Mean|-0.9|||||TWO_SIDED|90.0|-3.7|1.9||||||1.5 hr Post dose||1.9|-3.7|
72435821|NCT05046132|144384405|OTHER||LS Mean|-2.9|||||TWO_SIDED|90.0|-5.7|-0.2||||||2 hr Post dose||-0.2|-5.7|
72435822|NCT05046132|144384405|OTHER||LS Mean|-4.0|||||TWO_SIDED|90.0|-6.5|-1.5||||||2.5 hr Post dose||-1.5|-6.5|
72435823|NCT05046132|144384405|OTHER||LS Mean|-4.2|||||TWO_SIDED|90.0|-7.1|-1.3||||||3 hr Post dose||-1.3|-7.1|
72435824|NCT05046132|144384405|OTHER||LS Mean|-4.1|||||TWO_SIDED|90.0|-7.4|-0.8||||||4 hr Post dose||-0.8|-7.4|
72435825|NCT05046132|144384405|OTHER||LS Mean|-0.8|||||TWO_SIDED|90.0|-3.7|2.1||||||5 hr Post dose||2.1|-3.7|
72435826|NCT05046132|144384405|OTHER||LS Mean|-3.3|||||TWO_SIDED|90.0|-6.3|-0.4||||||6 hr Post dose||-0.4|-6.3|
72435827|NCT05046132|144384405|OTHER||LS Mean|-3.3|||||TWO_SIDED|90.0|-6.0|-0.5||||||7 hr Post dose||-0.5|-6.0|
72435828|NCT05046132|144384405|OTHER||LS Mean|-1.6|||||TWO_SIDED|90.0|-4.7|1.5||||||8 hr Post dose||1.5|-4.7|
72435829|NCT05046132|144384405|OTHER||LS Mean|-4.0|||||TWO_SIDED|90.0|-6.9|-1.2||||||9 hr Post dose||-1.2|-6.9|
72435830|NCT05046132|144384405|OTHER||LS Mean|-4.3|||||TWO_SIDED|90.0|-7.6|-1.0||||||10 hr Post dose||-1.0|-7.6|
72435831|NCT05046132|144384405|OTHER||LS Mean|-5.4|||||TWO_SIDED|90.0|-8.7|-2.1||||||12 hr Post dose||-2.1|-8.7|
72435832|NCT05046132|144384405|OTHER||LS Mean|-4.1|||||TWO_SIDED|90.0|-7.4|-0.8||||||16 hr Post dose||-0.8|-7.4|
72435833|NCT05046132|144384405|OTHER||LS Mean|-7.1|||||TWO_SIDED|90.0|-10.1|-4.2||||||24 hr Post dose||-4.2|-10.1|
72435834|NCT05046132|144384405|OTHER||LS Mean|1.1|||||TWO_SIDED|90.0|-2.0|4.2||||||Pre dose||4.2|-2.0|
72435835|NCT05046132|144384405|OTHER||LS Mean|3.1|||||TWO_SIDED|90.0|-0.1|6.3||||||0.5 hr Post dose||6.3|-0.1|
72435836|NCT05046132|144384405|OTHER||LS Mean|2.4|||||TWO_SIDED|90.0|-0.1|4.9||||||1 hr Post dose||4.9|-0.1|
72435837|NCT05046132|144384405|OTHER||LS Mean|3.0|||||TWO_SIDED|90.0|0.2|5.8||||||1.5 hr Post dose||5.8|0.2|
72435838|NCT05046132|144384405|OTHER||LS Mean|1.8|||||TWO_SIDED|90.0|-1.0|4.6||||||2 hr Post dose||4.6|-1.0|
72435839|NCT05046132|144384405|OTHER||LS Mean|0.6|||||TWO_SIDED|90.0|-1.9|3.1||||||2.5 hr Post dose||3.1|-1.9|
72435840|NCT05046132|144384405|OTHER||LS Mean|1.9|||||TWO_SIDED|90.0|-1.0|4.8||||||3 hr Post dose||4.8|-1.0|
72435841|NCT05046132|144384405|OTHER||LS Mean|-0.3|||||TWO_SIDED|90.0|-3.5|3.0||||||4 hr Post dose||3.0|-3.5|
72435842|NCT05046132|144384405|OTHER||LS Mean|0.3|||||TWO_SIDED|90.0|-2.6|3.2||||||5 hr Post dose||3.2|-2.6|
72435843|NCT05046132|144384405|OTHER||LS Mean|-1.9|||||TWO_SIDED|90.0|-4.8|1.1||||||6 hr Post dose||1.1|-4.8|
72435844|NCT05046132|144384405|OTHER||LS Mean|-1.1|||||TWO_SIDED|90.0|-3.8|1.7||||||7 hr Post dose||1.7|-3.8|
72435845|NCT05046132|144384405|OTHER||LS Mean|-0.5|||||TWO_SIDED|90.0|-3.6|2.6||||||8 hr Post dose||2.6|-3.6|
72435846|NCT05046132|144384405|OTHER||LS Mean|-2.7|||||TWO_SIDED|90.0|-5.6|0.2||||||9 hr Post dose||0.2|-5.6|
72435847|NCT05046132|144384405|OTHER||LS Mean|-3.5|||||TWO_SIDED|90.0|-6.8|-0.2||||||10 hr Post dose||-0.2|-6.8|
72435848|NCT05046132|144384405|OTHER||LS Mean|-3.3|||||TWO_SIDED|90.0|-6.6|0.1||||||12 hr Post dose||0.1|-6.6|
72435849|NCT05046132|144384405|OTHER||LS Mean|0.3|||||TWO_SIDED|90.0|-3.0|3.6||||||16 hr Post dose||3.6|-3.0|
72435850|NCT05046132|144384405|OTHER||LS Mean|-0.1|||||TWO_SIDED|90.0|-3.0|2.9||||||24 hr Post dose||2.9|-3.0|
72435851|NCT05046132|144384406|OTHER||LS Mean|-6.6|||||TWO_SIDED|90.0|-10.3|-3.0||||||Pre dose||-3.0|-10.3|
72435852|NCT05046132|144384406|OTHER||LS Mean|-7.3|||||TWO_SIDED|90.0|-10.5|-4.0||||||0.5 hr Post dose||-4.0|-10.5|
72435853|NCT05046132|144384406|OTHER||LS Mean|-5.0|||||TWO_SIDED|90.0|-8.8|-1.2||||||1 hr Post dose||-1.2|-8.8|
72435854|NCT05046132|144384406|OTHER||LS Mean|-5.0|||||TWO_SIDED|90.0|-8.4|-1.6||||||1.5 hr Post dose||-1.6|-8.4|
72435855|NCT05046132|144384406|OTHER||LS Mean|-3.5|||||TWO_SIDED|90.0|-6.6|-0.3||||||2 hr Post dose||-0.3|-6.6|
72558145|NCT02727192|144645796|SUPERIORITY||Difference in Percentage of Participants|-9.3||||0.33|TWO_SIDED||||||Chi-squared|||||||0.33
72435856|NCT05046132|144384406|OTHER||LS Mean|-2.9|||||TWO_SIDED|90.0|-6.1|0.3||||||2.5 hr Post dose||0.3|-6.1|
72435857|NCT05046132|144384406|OTHER||LS Mean|-4.6|||||TWO_SIDED|90.0|-7.7|-1.5||||||3 hr Post dose||-1.5|-7.7|
72435858|NCT05046132|144384406|OTHER||LS Mean|-7.1|||||TWO_SIDED|90.0|-10.3|-3.8||||||4 hr Post dose||-3.8|-10.3|
72435859|NCT05046132|144384406|OTHER||LS Mean|-3.2|||||TWO_SIDED|90.0|-6.9|0.6||||||5 hr Post dose||0.6|-6.9|
72435860|NCT05046132|144384406|OTHER||LS Mean|-4.2|||||TWO_SIDED|90.0|-7.8|-0.6||||||6 hr Post dose||-0.6|-7.8|
72435861|NCT05046132|144384406|OTHER||LS Mean|-4.8|||||TWO_SIDED|90.0|-8.1|-1.6||||||7 hr Post dose||-1.6|-8.1|
72435862|NCT05046132|144384406|OTHER||LS Mean|-4.4|||||TWO_SIDED|90.0|-7.8|-1.1||||||8 hr Post dose||-1.1|-7.8|
72435863|NCT05046132|144384406|OTHER||LS Mean|-5.9|||||TWO_SIDED|90.0|-9.3|-2.6||||||9 hr Post dose||-2.6|-9.3|
72435864|NCT05046132|144384406|OTHER||LS Mean|-4.4|||||TWO_SIDED|90.0|-7.8|-1.1||||||10 hr Post dose||-1.1|-7.8|
72435865|NCT05046132|144384406|OTHER||LS Mean|-4.2|||||TWO_SIDED|90.0|-7.3|-1.1||||||12 hr Post dose||-1.1|-7.3|
72435866|NCT05046132|144384406|OTHER||LS Mean|-5.8|||||TWO_SIDED|90.0|-9.7|-2.0||||||16 hr Post dose||-2.0|-9.7|
72435867|NCT05046132|144384406|OTHER||LS Mean|-8.2|||||TWO_SIDED|90.0|-12.5|-3.8||||||24 hr Post dose||-3.8|-12.5|
72435868|NCT05046132|144384406|OTHER||LS Mean|2.4|||||TWO_SIDED|90.0|-1.2|5.9||||||Pre dose||5.9|-1.2|
72494341|NCT01703858|144517599|NON_INFERIORITY_OR_EQUIVALENCE|Assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMeans) with acceptance range of 80.00 to 125.00%|Ratio of Geometric means (%)|83.46|STANDARD_DEVIATION|18.7||0.2771|TWO_SIDED|90.0|73.774|94.412|||ANOVA|Relative bioavailability was estimated by the ratios of the adjusted geometric means. CIs were calculated based on the residual error.|Analysis of variance includes the effects: sequence, subjects nested within sequences, period and treatment in crossover; subject and treatment in fixed sequence. Standard deviation is actually Intra individual geometric coefficient of variation.|E : BI-113608 vs. B : BI-113608 - Food effect||94.412|73.774|0.2771
72558146|NCT02727192|144645799|SUPERIORITY||Mean Difference (Net)|2.8||||0.058|TWO_SIDED|95.0|-0.1|5.8|||Regression, Linear|||Mental Component Summary score||5.8|-0.1|0.058
72558147|NCT02727192|144645799|SUPERIORITY||Mean Difference (Net)|-2.1||||0.16|TWO_SIDED|95.0|-5.1|0.8|||Regression, Linear|||Physical Component Summary score||0.8|-5.1|0.160
72435869|NCT05046132|144384406|OTHER||LS Mean|-1.4|||||TWO_SIDED|90.0|-4.5|1.8||||||0.5 hr Post dose||1.8|-4.5|
72435870|NCT05046132|144384406|OTHER||LS Mean|-0.4|||||TWO_SIDED|90.0|-4.0|3.3||||||1 hr Post dose||3.3|-4.0|
72435871|NCT05046132|144384406|OTHER||LS Mean|0.3|||||TWO_SIDED|90.0|-3.0|3.6||||||1.5 hr Post dose||3.6|-3.0|
72435872|NCT05046132|144384406|OTHER||LS Mean|-1.0|||||TWO_SIDED|90.0|-4.0|2.0||||||2 hr Post dose||2.0|-4.0|
72435873|NCT05046132|144384406|OTHER||LS Mean|0.5|||||TWO_SIDED|90.0|-2.6|3.6||||||2.5 hr Post dose||3.6|-2.6|
72435874|NCT05046132|144384406|OTHER||LS Mean|-0.7|||||TWO_SIDED|90.0|-3.7|2.3||||||3 hr Post dose||2.3|-3.7|
72435875|NCT05046132|144384406|OTHER||LS Mean|-2.3|||||TWO_SIDED|90.0|-5.4|0.9||||||4 hr Post dose||0.9|-5.4|
72435876|NCT05046132|144384406|OTHER||LS Mean|1.1|||||TWO_SIDED|90.0|-2.5|4.6||||||5 hr Post dose||4.6|-2.5|
72435877|NCT05046132|144384406|OTHER||LS Mean|-0.7|||||TWO_SIDED|90.0|-4.1|2.8||||||6 hr Post dose||2.8|-4.1|
72435878|NCT05046132|144384406|OTHER||LS Mean|-1.9|||||TWO_SIDED|90.0|-5.0|1.3||||||7 hr Post dose||1.3|-5.0|
72435879|NCT05046132|144384406|OTHER||LS Mean|-0.5|||||TWO_SIDED|90.0|-3.7|2.8||||||8 hr Post dose||2.8|-3.7|
72435880|NCT05046132|144384406|OTHER||LS Mean|-0.1|||||TWO_SIDED|90.0|-3.4|3.1||||||9 hr Post dose||3.1|-3.4|
72435881|NCT05046132|144384406|OTHER||LS Mean|0.4|||||TWO_SIDED|90.0|-2.8|3.7||||||10 hr Post dose||3.7|-2.8|
72435882|NCT05046132|144384406|OTHER||LS Mean|0.1|||||TWO_SIDED|90.0|-2.9|3.1||||||12 hr Post dose||3.1|-2.9|
72435883|NCT05046132|144384406|OTHER||LS Mean|0.6|||||TWO_SIDED|90.0|-3.1|4.3||||||16 hr Post dose||4.3|-3.1|
72435884|NCT05046132|144384406|OTHER||LS Mean|1.7|||||TWO_SIDED|90.0|-2.5|5.9||||||24 hr Post dose||5.9|-2.5|
72435885|NCT05046132|144384407|OTHER||LS Mean|-0.7|||||TWO_SIDED|90.0|-2.6|1.2||||||Pre dose||1.2|-2.6|
72435886|NCT05046132|144384407|OTHER||LS Mean|-0.9|||||TWO_SIDED|90.0|-2.6|0.7||||||0.5 hr post dose||0.7|-2.6|
72435887|NCT05046132|144384407|OTHER||LS Mean|0.6|||||TWO_SIDED|90.0|-1.1|2.3||||||1 hr post dose||2.3|-1.1|
72435888|NCT05046132|144384407|OTHER||LS Mean|-0.1|||||TWO_SIDED|90.0|-1.5|1.3||||||1.5 hr post dose||1.3|-1.5|
72435889|NCT05046132|144384407|OTHER||LS Mean|0.8|||||TWO_SIDED|90.0|-0.8|2.4||||||2 hr post dose||2.4|-0.8|
72435890|NCT05046132|144384407|OTHER||LS Mean|0.7|||||TWO_SIDED|90.0|-1.0|2.4||||||2.5 hr post dose||2.4|-1.0|
72435891|NCT05046132|144384407|OTHER||LS Mean|0.2|||||TWO_SIDED|90.0|-1.6|2.0||||||3 hr post dose||2.0|-1.6|
72435892|NCT05046132|144384407|OTHER||LS Mean|0.7|||||TWO_SIDED|90.0|-0.9|2.3||||||4 hr post dose||2.3|-0.9|
72435893|NCT05046132|144384407|OTHER||LS Mean|0.5|||||TWO_SIDED|90.0|-1.2|2.1||||||5 hr post dose||2.1|-1.2|
72435894|NCT05046132|144384407|OTHER||LS Mean|0.9|||||TWO_SIDED|90.0|-0.7|2.4||||||6 hr post dose||2.4|-0.7|
72435895|NCT05046132|144384407|OTHER||LS Mean|0.9|||||TWO_SIDED|90.0|-0.6|2.4||||||7 hr post dose||2.4|-0.6|
72435896|NCT05046132|144384407|OTHER||LS Mean|0.6|||||TWO_SIDED|90.0|-1.0|2.2||||||8 hr post dose||2.2|-1.0|
72435897|NCT05046132|144384407|OTHER||LS Mean|-0.2|||||TWO_SIDED|90.0|-1.6|1.3||||||9 hr post dose||1.3|-1.6|
72435898|NCT05046132|144384407|OTHER||LS Mean|0.0|||||TWO_SIDED|90.0|-1.5|1.6||||||10 hr post dose||1.6|-1.5|
72435899|NCT05046132|144384407|OTHER||LS Mean|1.4|||||TWO_SIDED|90.0|-0.2|3.0||||||12 hr post dose||3.0|-0.2|
72435900|NCT05046132|144384407|OTHER||LS Mean|1.5|||||TWO_SIDED|90.0|-0.3|3.4||||||16 hr post dose||3.4|-0.3|
72435901|NCT05046132|144384407|OTHER||LS Mean|-0.2|||||TWO_SIDED|90.0|-2.1|1.6||||||24 hr post dose||1.6|-2.1|
72435902|NCT05046132|144384407|OTHER||LS Mean|0.7|||||TWO_SIDED|90.0|-1.2|2.6||||||Pre dose||2.6|-1.2|
72435903|NCT05046132|144384407|OTHER||LS Mean|-0.3|||||TWO_SIDED|90.0|-1.9|1.4||||||0.5 hr post dose||1.4|-1.9|
72435904|NCT05046132|144384407|OTHER||LS Mean|0.5|||||TWO_SIDED|90.0|-1.2|2.2||||||1 hr post dose||2.2|-1.2|
72435905|NCT05046132|144384407|OTHER||LS Mean|0.7|||||TWO_SIDED|90.0|-0.7|2.1||||||1.5 hr post dose||2.1|-0.7|
72435906|NCT05046132|144384407|OTHER||LS Mean|0.6|||||TWO_SIDED|90.0|-1.1|2.2||||||2 hr post dose||2.2|-1.1|
72435907|NCT05046132|144384407|OTHER||LS Mean|0.8|||||TWO_SIDED|90.0|-0.9|2.5||||||2.5 hr post dose||2.5|-0.9|
72383812|NCT01675427|144275928|SUPERIORITY_OR_OTHER|||||||0.4884|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Other genotypes||||0.4884
72383813|NCT01675427|144275928|SUPERIORITY_OR_OTHER|||||||0.6119|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Total genotypes||||0.6119
72383814|NCT01675427|144275929|SUPERIORITY_OR_OTHER|||||||0.2416|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G1||||0.2416
72383815|NCT01675427|144275929|SUPERIORITY_OR_OTHER|||||||0.2671|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G2||||0.2671
72383816|NCT01675427|144275929|SUPERIORITY_OR_OTHER|||||||0.4619|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G3||||0.4619
72383817|NCT01675427|144275929|SUPERIORITY_OR_OTHER|||||||0.8364|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G4||||0.8364
72383818|NCT01675427|144275929|SUPERIORITY_OR_OTHER|||||||0.2386|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Other genotypes||||0.2386
72383819|NCT01675427|144275929|SUPERIORITY_OR_OTHER|||||||0.2887|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Total genotypes||||0.2887
72383820|NCT01675427|144275930|SUPERIORITY_OR_OTHER|||||||0.0049|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three IL28B genotype categories|Cochran-Armitage Trend Test|||||||0.0049
72383821|NCT01675427|144275931|SUPERIORITY_OR_OTHER|||||||0.5651|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three IL28B genotype categories|Cochran-Armitage Trend Test|||||||0.5651
72383822|NCT01675427|144275932|SUPERIORITY_OR_OTHER|||||||0.042|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three IL28B genotype categories|Cochran-Armitage Trend Test|||||||0.0420
72435908|NCT05046132|144384407|OTHER||LS Mean|0.3|||||TWO_SIDED|90.0|-1.5|2.1||||||3 hr post dose||2.1|-1.5|
72435909|NCT05046132|144384407|OTHER||LS Mean|-0.5|||||TWO_SIDED|90.0|-2.1|1.1||||||4 hr post dose||1.1|-2.1|
72435910|NCT05046132|144384407|OTHER||LS Mean|0.2|||||TWO_SIDED|90.0|-1.5|1.9||||||5 hr post dose||1.9|-1.5|
72435911|NCT05046132|144384407|OTHER||LS Mean|-0.2|||||TWO_SIDED|90.0|-1.7|1.4||||||6 hr post dose||1.4|-1.7|
72435912|NCT05046132|144384407|OTHER||LS Mean|-0.1|||||TWO_SIDED|90.0|-1.6|1.4||||||7 hr post dose||1.4|-1.6|
72435913|NCT05046132|144384407|OTHER||LS Mean|0.8|||||TWO_SIDED|90.0|-0.7|2.4||||||8 hr post dose||2.4|-0.7|
72435914|NCT05046132|144384407|OTHER||LS Mean|-0.2|||||TWO_SIDED|90.0|-1.6|1.3||||||9 hr post dose||1.3|-1.6|
72435915|NCT05046132|144384407|OTHER||LS Mean|0.1|||||TWO_SIDED|90.0|-1.4|1.6||||||10 hr post dose||1.6|-1.4|
72435916|NCT05046132|144384407|OTHER||LS Mean|1.5|||||TWO_SIDED|90.0|-0.1|3.1||||||12 hr post dose||3.1|-0.1|
72435917|NCT05046132|144384407|OTHER||LS Mean|1.2|||||TWO_SIDED|90.0|-0.7|3.0||||||16 hr post dose||3.0|-0.7|
72435918|NCT05046132|144384407|OTHER||LS Mean|1.5|||||TWO_SIDED|90.0|-0.3|3.4||||||24 hr post dose||3.4|-0.3|
72435919|NCT05046132|144384408|OTHER||LS Mean|0.8|||||TWO_SIDED|90.0|-1.3|2.9||||||Pre dose||2.9|-1.3|
72435920|NCT05046132|144384408|OTHER||LS Mean|-0.3|||||TWO_SIDED|90.0|-1.8|1.2||||||0.5 hr post dose||1.2|-1.8|
72435921|NCT05046132|144384408|OTHER||LS Mean|1.2|||||TWO_SIDED|90.0|-1.4|3.8||||||1 hr post dose||3.8|-1.4|
72435922|NCT05046132|144384408|OTHER||LS Mean|0.0|||||TWO_SIDED|90.0|-1.8|1.8||||||1.5 hr post dose||1.8|-1.8|
72435923|NCT05046132|144384408|OTHER||LS Mean|-1.4|||||TWO_SIDED|90.0|-3.0|0.3||||||2 hr post dose||0.3|-3.0|
72435924|NCT05046132|144384408|OTHER||LS Mean|1.6|||||TWO_SIDED|90.0|0.0|3.1||||||2.5 hr post dose||3.1|-0.0|
72435925|NCT05046132|144384408|OTHER||LS Mean|-0.1|||||TWO_SIDED|90.0|-1.7|1.5||||||3 hr post dose||1.5|-1.7|
72435926|NCT05046132|144384408|OTHER||LS Mean|1.3|||||TWO_SIDED|90.0|-0.3|2.9||||||4 hr post dose||2.9|-0.3|
72435927|NCT05046132|144384408|OTHER||LS Mean|-0.1|||||TWO_SIDED|90.0|-2.2|2.0||||||5 hr post dose||2.0|-2.2|
72435928|NCT05046132|144384408|OTHER||LS Mean|0.7|||||TWO_SIDED|90.0|-0.8|2.3||||||6 hr post dose||2.3|-0.8|
72435929|NCT05046132|144384408|OTHER||LS Mean|0.9|||||TWO_SIDED|90.0|-0.8|2.7||||||7 hr post dose||2.7|-0.8|
72435930|NCT05046132|144384408|OTHER||LS Mean|1.0|||||TWO_SIDED|90.0|-0.3|2.4||||||8 hr post dose||2.4|-0.3|
72435931|NCT05046132|144384408|OTHER||LS Mean|1.1|||||TWO_SIDED|90.0|-0.7|2.9||||||9 hr post dose||2.9|-0.7|
72435932|NCT05046132|144384408|OTHER||LS Mean|0.3|||||TWO_SIDED|90.0|-1.4|1.9||||||10 hr post dose||1.9|-1.4|
72435933|NCT05046132|144384408|OTHER||LS Mean|1.3|||||TWO_SIDED|90.0|-0.6|3.2||||||12 hr post dose||3.2|-0.6|
72435934|NCT05046132|144384408|OTHER||LS Mean|0.7|||||TWO_SIDED|90.0|-1.0|2.4||||||16 hr post dose||2.4|-1.0|
72435935|NCT05046132|144384408|OTHER||LS Mean|1.6|||||TWO_SIDED|90.0|-1.0|4.2||||||24 hr post dose||4.2|-1.0|
72435936|NCT05046132|144384408|OTHER||LS Mean|-0.3|||||TWO_SIDED|90.0|-2.3|1.7||||||Pre dose||1.7|-2.3|
72435937|NCT05046132|144384408|OTHER||LS Mean|-0.1|||||TWO_SIDED|90.0|-1.6|1.3||||||0.5 hr post dose||1.3|-1.6|
72435938|NCT05046132|144384408|OTHER||LS Mean|-1.3|||||TWO_SIDED|90.0|-3.8|1.2||||||1 hr post dose||1.2|-3.8|
72435939|NCT05046132|144384408|OTHER||LS Mean|0.1|||||TWO_SIDED|90.0|-1.7|1.8||||||1.5 hr post dose||1.8|-1.7|
72435940|NCT05046132|144384408|OTHER||LS Mean|-1.1|||||TWO_SIDED|90.0|-2.7|0.5||||||2 hr post dose||0.5|-2.7|
72435941|NCT05046132|144384408|OTHER||LS Mean|0.7|||||TWO_SIDED|90.0|-0.8|2.3||||||2.5 hr post dose||2.3|-0.8|
72435942|NCT05046132|144384408|OTHER||LS Mean|0.2|||||TWO_SIDED|90.0|-1.3|1.8||||||3 hr post dose||1.8|-1.3|
72435943|NCT05046132|144384408|OTHER||LS Mean|0.3|||||TWO_SIDED|90.0|-1.2|1.9||||||4 hr post dose||1.9|-1.2|
72435944|NCT05046132|144384408|OTHER||LS Mean|-1.5|||||TWO_SIDED|90.0|-3.5|0.5||||||5 hr post dose||0.5|-3.5|
72435945|NCT05046132|144384408|OTHER||LS Mean|0.9|||||TWO_SIDED|90.0|-0.6|2.3||||||6 hr post dose||2.3|-0.6|
72435946|NCT05046132|144384408|OTHER||LS Mean|0.4|||||TWO_SIDED|90.0|-1.3|2.1||||||7 hr post dose||2.1|-1.3|
72435947|NCT05046132|144384408|OTHER||LS Mean|1.3|||||TWO_SIDED|90.0|0.0|2.6||||||8 hr post dose||2.6|-0.0|
72558148|NCT02727192|144645800|SUPERIORITY||Mean Difference (Net)|-0.9||||0.11|TWO_SIDED|95.0|-2.0|0.2|||Regression, Linear|||||0.2|-2.0|0.110
72558149|NCT02727192|144645802|SUPERIORITY||Mean Difference (Net)|0.1||||0.85|TWO_SIDED|95.0|-0.5|0.6|||Regression, Linear|||||0.6|-0.5|0.850
72558150|NCT02727192|144645804|SUPERIORITY||Median Difference (Net)|0.3||||0.65|TWO_SIDED|95.0|-1.0|1.6|||Regression, Linear|||||1.6|-1.0|0.650
72558151|NCT02727192|144645805|SUPERIORITY||Mean Difference (Net)|2.6||||0.006|TWO_SIDED|95.0|0.8|4.5|||Regression, Linear|||||4.5|0.8|0.006
72383823|NCT01675427|144275933|SUPERIORITY_OR_OTHER|||||||0.4545|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three IL28B genotype categories|Cochran-Armitage Trend Test|||||||0.4545
72383824|NCT01675427|144275934|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Pearson Chi-Square Tests for association between the two variables|Chi-squared|||||||< 0.0001
72383825|NCT01675427|144275935|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Pearson Chi-Square Tests for association between the two variables|Chi-squared|||||||< 0.0001
72383826|NCT01675427|144275936|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Pearson Chi-Square Tests for association between the two variables|Chi-squared|||||||< 0.0001
72383827|NCT01675427|144275937|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Pearson Chi-Square Tests for association between the two variables|Chi-squared|||||||< 0.0001
72383828|NCT01675427|144275938|SUPERIORITY_OR_OTHER|||||||0.5468|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||||||0.5468
72383829|NCT01675427|144275939|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||||||0.0020
72383830|NCT01675427|144275940|SUPERIORITY_OR_OTHER|||||||0.1623|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||||||0.1623
72383831|NCT01675427|144275941|SUPERIORITY_OR_OTHER|||||||0.0663|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||||||0.0663
72383832|NCT01675427|144275942|SUPERIORITY_OR_OTHER|||||||0.2617|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||||||0.2617
72383833|NCT01675427|144275943|SUPERIORITY_OR_OTHER|||||||0.0526|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||||||0.0526
72383834|NCT01675427|144275944|SUPERIORITY_OR_OTHER|||||||0.7918|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||||||0.7918
72383835|NCT01675427|144275945|SUPERIORITY_OR_OTHER|||||||0.0842|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||||||0.0842
72383836|NCT01675427|144275946|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Pearson Chi-Square Tests for association between the two variables|Chi-squared|||||||< 0.0001
72383837|NCT01675427|144275947|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Pearson Chi-Square Tests for association between the two variables|Chi-squared|||||||< 0.0001
72383838|NCT01675427|144275948|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Pearson Chi-Square Tests for association between the two variables|Chi-squared|||||||< 0.0001
72435948|NCT05046132|144384408|OTHER||LS Mean|0.4|||||TWO_SIDED|90.0|-1.3|2.2||||||9 hr post dose||2.2|-1.3|
72435949|NCT05046132|144384408|OTHER||LS Mean|-1.1|||||TWO_SIDED|90.0|-2.7|0.5||||||10 hr post dose||0.5|-2.7|
72435950|NCT05046132|144384408|OTHER||LS Mean|-0.3|||||TWO_SIDED|90.0|-2.1|1.5||||||12 hr post dose||1.5|-2.1|
72435951|NCT05046132|144384408|OTHER||LS Mean|-0.2|||||TWO_SIDED|90.0|-1.9|1.4||||||16 hr post dose||1.4|-1.9|
72435952|NCT05046132|144384408|OTHER||LS Mean|2.3|||||TWO_SIDED|90.0|-0.2|4.9||||||24 hr post dose||4.9|-0.2|
72435953|NCT04246762|144384434|OTHER||geometric LS mean ratio of AUC (0-inf))|70.46|||||TWO_SIDED|90.0|60.62|81.91|||||Results based on a linear mixed model for the log-transformed values of PK parameters of midazolam with a fixed effect for treatment and a random effect for subject.|Estimate of the mean difference between treatments (midazolam (as part of a 4-drug oral cocktail) after OKZ administration compared to midazolam (as part of a 4-drug oral cocktail) administrated alone) and its corresponding 90% confidence interval (CI) were calculated. The mean difference and the CI were back transformed to the original scale to obtain estimates of the geometric mean ratio and the associated 90% CI.||81.91|60.62|
72435954|NCT04246762|144384434|OTHER||geometric LS mean ratio of AUC (0-inf))|67.87|||||TWO_SIDED|90.0|56.73|81.21|||||Results based on a linear mixed model for the log-transformed values of PK parameters of omeprazole with a fixed effect for treatment and a random effect for subject.|Estimate of the mean difference between treatments (omeprazole (as part of a 4-drug oral cocktail) after OKZ administration compared to omeprazole (as part of a 4-drug oral cocktail) administrated alone) and its corresponding 90% confidence interval (CI) were calculated. The mean difference and the CI were back transformed to the original scale to obtain estimates of the geometric mean ratio and the associated 90% CI.||81.21|56.73|
72435955|NCT04246762|144384434|OTHER||geometric LS mean ratio of AUC (0-inf))|122.92|||||TWO_SIDED|90.0|107.98|139.93|||||Results based on a linear mixed model for the log-transformed values of baseline-adjusted PK parameters of caffeine with a with fixed effect for treatment and a random effect for subject.|Estimate of the mean difference between treatments (caffeine (as part of a 4-drug oral cocktail) after OKZ administration compared to caffeine (as part of a 4-drug oral cocktail) administrated alone) and its corresponding 90% confidence interval (CI) were calculated. The mean difference and the CI were back transformed to the original scale to obtain estimates of the geometric mean ratio and the associated 90% CI.||139.93|107.98|
72558152|NCT02727192|144645806|SUPERIORITY||Median Difference (Net)|-31.4||||0.389|TWO_SIDED|95.0|-103.4|40.7|||Regression, Linear|||||40.7|-103.4|0.389
72558153|NCT02727192|144645809|SUPERIORITY||Mean Difference (Net)|0.1||||0.697|TWO_SIDED|95.0|-0.3|0.5|||Regression, Logistic|||||0.5|-0.3|0.697
72618744|NCT01026038|144768109|SUPERIORITY_OR_OTHER||GMT ratio|0.6|||||TWO_SIDED|95.0|0.45|0.78||||||Serotype 3: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||0.78|0.45|
72494342|NCT01703858|144517599|NON_INFERIORITY_OR_EQUIVALENCE|Assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMeans) with acceptance range of 80.00 to 125.00%|Ratio of Geometric means (%)|117.16|STANDARD_DEVIATION|16.6||0.1584|TWO_SIDED|90.0|104.958|130.787|||ANOVA|Relative bioavailability was estimated by the ratios of the adjusted geometric means. CIs were calculated based on the residual error.|Analysis of variance includes the effects: sequence, subjects nested within sequences, period and treatment in crossover; subject and treatment in fixed sequence. Standard deviation is actually Intra individual geometric coefficient of variation.|E : BI-113608 vs. C : BI-113608 - Food effect||130.787|104.958|0.1584
72435956|NCT04246762|144384435|OTHER||geometric LS mean ratio of AUC (0-last))|90.83|||||TWO_SIDED|90.0|86.72|95.13|||||Results based on a linear mixed model for the log-transformed values of PK parameters of S-warfarin with a fixed effect for treatment and a random effect for subject.|Estimate of the mean difference between treatments (S-warfarin (as part of a 4-drug oral cocktail) after OKZ administration compared to initial S-warfarin administrated alone (as part of a 4-drug oral cocktail)) and its corresponding 90% confidence interval (CI) was calculated. The mean difference and the CI were back transformed to the original scale to obtain estimate of the geometric mean ratio and the associated 90% CI.||95.13|86.72|
72435957|NCT04246762|144384436|OTHER||geometric LS mean ratio of Cmax|68.5|||||TWO_SIDED|90.0|59.46|78.92|||||Results based on a linear mixed model for the log-transformed values of PK parameters of midazolam with a fixed effect for treatment and a random effect for subject.|Estimate of the mean difference between treatments (midazolam (as part of a 4-drug oral cocktail) after OKZ administration compared to midazolam (as part of a 4-drug oral cocktail) administrated alone) and its corresponding 90% confidence interval (CI) were calculated. The mean difference and the CI were back transformed to the original scale to obtain estimates of the geometric mean ratio and the associated 90% CI.||78.92|59.46|
72435958|NCT04246762|144384436|OTHER||geometric LS mean ratio of Cmax|73.54|||||TWO_SIDED|90.0|64.18|84.27|||||Results based on a linear mixed model for the log-transformed values of PK parameters of omeprazole with a fixed effect for treatment and a random effect for subject.|Estimate of the mean difference between treatments (omeprazole (as part of a 4-drug oral cocktail) after OKZ administration compared to omeprazole (as part of a 4-drug oral cocktail) administrated alone) and its corresponding 90% confidence interval (CI) were calculated. The mean difference and the CI were back transformed to the original scale to obtain estimates of the geometric mean ratio and the associated 90% CI.||84.27|64.18|
72435959|NCT04246762|144384436|OTHER||geometric LS mean ratio of Cmax|97.99|||||TWO_SIDED|90.0|91.36|105.09|||||Results based on a linear mixed model for the log-transformed values of baseline-adjusted PK parameters of caffeine with a with fixed effect for treatment and a random effect for subject.|Estimate of the mean difference between treatments (caffeine (as part of a 4-drug oral cocktail) after OKZ administration compared to caffeine (as part of a 4-drug oral cocktail) administrated alone) and its corresponding 90% confidence interval (CI) were calculated. The mean difference and the CI were back transformed to the original scale to obtain estimates of the geometric mean ratio and the associated 90% CI.||105.09|91.36|
72494343|NCT01703858|144517599|NON_INFERIORITY_OR_EQUIVALENCE|Assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMeans) with acceptance range of 80.00 to 125.00%|Ratio of Geometric means (%)|97.41|STANDARD_DEVIATION|15.8||0.002|TWO_SIDED|90.0|88.066|107.741|||ANOVA|Relative bioavailability was estimated by the ratios of the adjusted geometric means. CIs were calculated based on the residual error.|Analysis of variance includes the effects: sequence, subjects nested within sequences, period and treatment in crossover; subject and treatment in fixed sequence. Standard deviation is actually Intra individual geometric coefficient of variation.|D : BI-113608 vs. B : BI-113608 - Pantoprazole effect||107.741|88.066|0.0020
72494344|NCT03694925|144517619|OTHER||Specificity|0.871|||||TWO_SIDED||||||||Specificity was calculated using 2x2 tables using \>14 mg/L cut off. The numerator is the number of the true negatives and the denominator is the number of total negatives.|||||
72494345|NCT03694925|144517619|OTHER||Specificity|0.957|||||TWO_SIDED||||||||Specificity was calculated using 2x2 tables using \>50 mg/L cut off. The numerator is the number of the true negatives and the denominator is the number of total negatives.|||||
72494346|NCT03694925|144517619|OTHER||Sensitivity|0.981|||||TWO_SIDED||||||||Sensitivity was calculated using 2x2 tables using \>14 mg/L cut off. Sensitivity is the number of true positives over the number of total positives.|||||
72494347|NCT03694925|144517619|OTHER||Sensitivity|0.981|||||TWO_SIDED||||||||Sensitivity was calculated using 2x2 tables using \>50 mg/L cut off. Sensitivity is the number of true positives over the number of total positives.|||||
72494348|NCT03694925|144517619|OTHER||Positive predictive value|0.852|||||TWO_SIDED||||||||Positive predictive value was calculated using 2x2 tables using \>14 mg/L cut off. The numerator is the septic positives and the denominator are the total positives.|||||
72494349|NCT03694925|144517619|OTHER||Positive predictive value|0.945|||||TWO_SIDED||||||||Positive predictive value was calculated using 2x2 tables using \>50mg/L cut off. The numerator is the septic positives and the denominator are the total positives.|||||
72494350|NCT03694925|144517619|OTHER||Negative predictive value|0.984|||||TWO_SIDED||||||||Negative predictive value was calculated using 2x2 tables using \>14 mg/L cut off. The numerator is the aseptic negatives and the denominator is the number of total negatives.|||||
72494351|NCT03694925|144517619|OTHER||Negative predictive value|0.985|||||TWO_SIDED||||||||Negative predictive value was calculated using 2x2 tables using \>50 mg/L cut off. The numerator is the aseptic negatives and the denominator is the number of total negatives.|||||
72494352|NCT03694925|144517620|OTHER||Specificity|0.829|||||TWO_SIDED||||||||Specificity was calculated using 2x2 tables using \>14 mg/L cut off. The numerator is the number of the number of aseptic negatives and the denominator is the number of aseptics.|||||
72494353|NCT03694925|144517620|OTHER||Specificity|0.957|||||TWO_SIDED||||||||Specificity was calculated using 2x2 tables using \>50 mg/L cut off. The numerator is the number of the number of aseptic negatives and the denominator is the number of aseptics.|||||
72494354|NCT03694925|144517620|OTHER||Sensitivity|0.981|||||TWO_SIDED||||||||Sensitivity was calculated using 2x2 tables using \>14 mg/L cut off. Sensitivity is the number of septic positives over the number of septics.|||||
72618745|NCT01026038|144768109|SUPERIORITY_OR_OTHER||GMT ratio|1.2|||||TWO_SIDED|95.0|0.84|1.62||||||Serotype 5: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||1.62|0.84|
72435960|NCT04246762|144384436|OTHER||geometric LS mean ratio of Cmax|102.3|||||TWO_SIDED|90.0|94.8|110.39|||||Results based on a linear mixed model for the log-transformed values of PK parameters of S-warfarin with a fixed effect for treatment and a random effect for subject.|Estimate of the mean difference between treatments (S-warfarin (as part of a 4-drug oral cocktail) after OKZ administration compared to initial S-warfarin administrated alone (as part of a 4-drug oral cocktail)) and its corresponding 90% confidence interval (CI) was calculated. The mean difference and the CI were back transformed to the original scale to obtain estimate of the geometric mean ratio and the associated 90% CI. The sample size computation was based on results reported for sirukumab.||110.39|94.80|
72435961|NCT04495634|144384452|EQUIVALENCE|The equivalence margin was defined through power calculations based on sample size, power of 0.90 and alpha of 0.05 resulting in a margin of +/- 0.26.|||||<|0.0001|||||||ANOVA|||||||<0.0001
72435962|NCT04495634|144384453|EQUIVALENCE|The equivalence margin was defined through power calculations based on sample size, power of 0.90 and alpha of 0.05 resulting in a margin of +/- 0.26.||||||0.41|||||||ANOVA|||||||0.41
72435963|NCT04495634|144384454|EQUIVALENCE|The equivalence margin was defined through power calculations based on sample size, power of 0.90 and alpha of 0.05 resulting in a margin of +/- 0.26.||||||0.0001|||||||ANOVA|||||||0.0001
72435964|NCT04495634|144384455|EQUIVALENCE|The equivalence margin was defined through power calculations based on sample size, power of 0.90 and alpha of 0.05 resulting in a margin of +/- 0.26.||||||0.0001|||||||ANOVA|||||||0.0001
72435965|NCT02124460|144384463|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.02||||0.3928|TWO_SIDED|95.0|-0.08|0.03|||Linear repeated measures|Multiple imputation was used for missing follow-up data.|Health Coaching group compared to Enhanced Primary Care|||0.03|-0.08|0.3928
72435966|NCT02124460|144384464|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.89||||0.2306|TWO_SIDED|95.0|-0.56|2.33|||Linear repeated measures|Multiple imputation used for missing data at follow-up|Health Coaching group compared to Enhanced Primary Care|||2.33|-0.56|0.2306
72435967|NCT02124460|144384465|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.07||||0.14|TWO_SIDED|95.0|-0.02|0.16|||Linear repeated measures|Multiple imputation used for missing data at follow-up|Health Coaching group compared to Enhanced Primary Care.|||0.16|-0.02|.14
72435968|NCT02124460|144384466|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.5||||0.0016|TWO_SIDED|95.0|-0.81|-0.19|||Linear repeated measures|Multiple imputation used for missing data at follow-up.||||-0.19|-0.81|0.0016
72435969|NCT02124460|144384467|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.42|||<|0.0001|TWO_SIDED|95.0|0.22|0.62||Multiple imputation used for missing data at follow-up.|Linear repeated measures|||||0.62|0.22|<.0001
72435970|NCT02124460|144384468|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.18||||0.3043|TWO_SIDED|95.0|-0.16|0.53|||Linear repeated measures|Multiple imputation used for missing data at follow-up.||||0.53|-0.16|0.3043
72435971|NCT02124460|144384469|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.32||||0.0113|TWO_SIDED|95.0|0.07|0.56|||Linear repeated measures|Multiple imputation used for missing data at follow-up.||||0.56|0.07|0.0113
72494355|NCT03694925|144517620|OTHER||Sensitivity|0.981|||||TWO_SIDED||||||||Sensitivity was calculated using 2x2 tables using \>50 mg/L cut off. Sensitivity is the number of septic positives over the number of septics.|||||
72494356|NCT03694925|144517620|OTHER||Positive predictive value|0.813|||||TWO_SIDED||||||||Positive predictive value was calculated using 2x2 tables using \>14 mg/L cut off. The numerator is the septic positives and the denominator are the total positives.|||||
72494357|NCT03694925|144517620|OTHER||Positive predictive value|0.945|||||TWO_SIDED||||||||Positive predictive value was calculated using 2x2 tables using \>50mg/L cut off. The numerator is the septic positives and the denominator are the total positives.|||||
72435972|NCT02124460|144384470|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.21||||0.0792|TWO_SIDED|95.0|-0.45|0.03|||Linear repeated measures|Multiple imputation used for missing data at follow-up.||||0.03|-0.45|0.0792
72494358|NCT03694925|144517620|OTHER||Negative predictive value|0.983|||||TWO_SIDED||||||||Negative predictive value was calculated using 2x2 tables using \>14 mg/L cut off. The numerator is the aseptic negatives and the denominator is the number of total negatives.|||||
72435973|NCT03008915|144384490|OTHER|Paired t-test for participants with measures on both aspirin and placebo.||||||0.692|||||||t-test, 2 sided|||The null hypothesis is that there is no difference between measures on aspirin and placebo.||||0.692
72435974|NCT00712166|144384494|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.8||||0.433|TWO_SIDED|95.0|-2.83|6.44||"The primary endpoint analysis was based on a two-sided test with an 0.05 a priori threshold for statistical significance.~A gate-keeper approach was established a priori to control the type 1 error rate, however, the primary endpoint was not met."|ANCOVA|ANCOVA included: treatment, baseline CFQ-R RSS, age group (\<18, \>=18 years). Denominator degrees of freedom computed with Satterthwaite approximation.||"Null hypothesis was there was no difference between 75 mg AZLI TID and placebo treatment groups in change from baseline in CFQ-R RSS score at Day 28.~At the 5% significance level (i.e., α = 0.05) using a two-sided significance test, a sample size of 70 participants per treatment group provided at least 90% power to detect a 10 point difference between groups in the mean change from baseline at Day 28 in the CFQ-R RSS score, assuming a common standard deviation (SD) of 17.5."||6.44|-2.83|0.433
72494359|NCT03694925|144517620|OTHER||Negative predictive value|0.985|||||TWO_SIDED||||||||Negative predictive value was calculated using 2x2 tables using \>50 mg/L cut off. The numerator is the aseptic negatives and the denominator is the number of total negatives.||Negative predictive value was calculated using 2x2 tables using \>50 mg/L cut off. NPV=98.5%|||
72494360|NCT01639872|144517622|SUPERIORITY||difference in treatment means|0.014|STANDARD_ERROR_OF_MEAN|1.62||0.99|TWO_SIDED||||||Mixed Models Analysis||We report the estimated coefficient for difference in treatment means in a mixed model and its standard error.|||||.99
72494361|NCT01639872|144517623|SUPERIORITY||difference in treatment means|-0.32|STANDARD_ERROR_OF_MEAN|0.28||0.25|TWO_SIDED||||||Mixed Models Analysis||We report the estimated coefficient for difference in treatment means in a mixed model and its standard error.|||||.25
72494362|NCT02799069|144517624|NON_INFERIORITY|The sample size of 210 subjects per treatment arm (per protocol set) has a power of at least 90% to establish non-inferiority of BF-200 ALA to Metvix using a non-inferiority margin of -15% and assuming response rates of 70% for both BF-200 ALA and Metvix. The power calculation was based on a one-sided Z-test with continuity correction (unpooled) with a significance level of 0.025.The establishment of non-inferiority was performed for the PP set and verified for robustness on the ITT.|Difference to BF-200 ALA|14.0|||||ONE_SIDED|97.5|5.9||||||||||5.9|
72435975|NCT00712166|144384495|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.37||||0.133|TWO_SIDED|95.0|-1.04|7.78||No adjustments were made for multiple comparisons.|ANCOVA|ANCOVA included terms: treatment, baseline CFQ-R RSS, age group (\<18, \>=18 years). Treatment differences were calculated as AZLI-placebo.||Null hypothesis was there was no difference between 75 mg AZLI TID and placebo treatment groups in change from baseline in the CFQ-R RSS score at Day 14.||7.78|-1.04|0.133
72435976|NCT00712166|144384496|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||0.965|TWO_SIDED|95.0|-4.56|4.76||No adjustments were made for multiple comparisons.|ANCOVA|ANCOVA model included terms for treatment, baseline CFQ-R RSS and age group (\<18 years, \>=18 years). Treatment differences calculated as AZLI-placebo.||Null hypothesis was there was no difference between 75 mg AZLI TID and placebo treatment groups in change from baseline in the CFQ-R RSS score at Day 42.||4.76|-4.56|0.965
72435977|NCT00712166|144384497|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.47||||0.256||95.0|-1.81|6.76||No adjustments were made for multiple comparisons.|ANCOVA|ANCOVA included: treatment, baseline CFQ-R Physical Function Domain score and age (\<18, \>=18 years). Treatment differences calculated as AZLI-placebo.||Null hypothesis was there was no difference between 75 mg AZLI TID and placebo treatment groups in change from baseline in the CFQ-R physical functioning domain score at Day 28.||6.76|-1.81|0.256
72494363|NCT02799069|144517624|SUPERIORITY||Difference to BF-200 ALA|61.1||||0|TWO_SIDED|95.0|51.2|71.0|||Chi-squared|||"Superiority of BF-200 ALA compared to placebo:~A sample size of 264: 88 patients (BF-200 ALA: placebo) will have a power of more than 90% to establish superiority of BF-200 ALA over placebo, even if very conservative response rates of 65% for the BF-200 ALA group and 40% for placebo are assumed using a chi-square test with continuity correction and a two-sided significance level of 0.05."||71.0|51.2|0.0000
72494364|NCT02799069|144517625|NON_INFERIORITY|The sample size of 210 subjects per treatment arm (per protocol set) has a power of at least 90% to establish non-inferiority of BF-200 ALA to Metvix using a non-inferiority margin of -15% and assuming response rates of 70% for both BF-200 ALA and Metvix. The power calculation was based on a one-sided Z-test with continuity correction (unpooled) with a significance level of 0.025.The establishment of non-inferiority was performed for the PP set and verified for robustness on the ITT.|Difference to BF-200 ALA|14.2|||||ONE_SIDED|97.5|6.0||||||||||6.0|
72494365|NCT02799069|144517625|SUPERIORITY_OR_OTHER||Difference to BF-200 ALA|59.4||||0|TWO_SIDED|95.0|48.4|70.4|||Chi-squared|||||70.4|48.4|0.0000
72494366|NCT02799069|144517626|SUPERIORITY_OR_OTHER||Difference to BF-200 ALA|72.0||||0|TWO_SIDED|95.0|59.7|84.2|||Chi-squared|||||84.2|59.7|0.0000
72494367|NCT02799069|144517626|SUPERIORITY_OR_OTHER||Difference to BF-200 ALA|17.3|||||ONE_SIDED|97.5|6.6||||||||||6.6|
72494368|NCT05574062|144517707|NON_INFERIORITY|-7.5% non-inferiority margin|Mean Difference (Final Values)|9.88|||||TWO_SIDED|95.0|8.04|11.72|||Mixed Models Analysis||Mixed model adjusted for baseline (run-in) values|||11.72|8.04|
72494369|NCT05574062|144517708|NON_INFERIORITY|non-inferiority margin of 0.4% HbA1c|Mean Difference (Final Values)|0.14|||||TWO_SIDED|95.0|-0.03|0.31|||Regression, Linear||Linear regression model adjusted for baseline (continuation phase period1) values|||0.31|-0.03|
72494370|NCT05574062|144517709|NON_INFERIORITY|non- inferiority margin of 0.4%|Mean Difference (Final Values)|-0.61|||||TWO_SIDED|95.0|-0.76|-0.46|||Mixed Models Analysis||Mixed model adjusted for baseline (screening) values|||-0.46|-0.76|
72494371|NCT05574062|144517710|SUPERIORITY||Median Difference (Final Values)|9.88|||<|0.0001|TWO_SIDED|95.0|8.04|11.72|||Mixed Models Analysis||Mixed model adjusted for baseline (run-in) values|||11.72|8.04|<.0001
72494372|NCT05574062|144517711|SUPERIORITY||Mean Difference (Net)|-0.61|||<|0.0001|TWO_SIDED|95.0|-0.76|-0.46|||Mixed Models Analysis||Mixed model adjusted for baseline (screening) values|||-0.46|-0.76|<.0001
72494373|NCT05574062|144517712|SUPERIORITY||Mean Difference (Final Values)|0.14||||0.1097|TWO_SIDED|95.0|-0.03|0.31|||Regression, Linear||Linear regression model adjusted for baseline (period1) values|||0.31|-0.03|0.1097
72494374|NCT05574062|144517713|NON_INFERIORITY|non inferiority margin of -7.5%|Mean Difference (Net)|1.17|||||TWO_SIDED|95.0|-0.04|2.38|||Regression, Linear||Linear regression adjusted for baseline (continuation phase period 1) values|||2.38|-0.04|
72494375|NCT05574062|144517714|SUPERIORITY||Mean Difference (Final Values)|1.17||||0.0581|TWO_SIDED|95.0|-0.04|2.38|||Regression, Linear||Linear regression adjusted for baseline (continuation phase period 1) values|||2.38|-0.04|0.0581
72435978|NCT00712166|144384498|SUPERIORITY_OR_OTHER||||||>|0.999||0.0||||No adjustments were made for multiple comparisons.|Fisher Exact|A participant with multiple usage was counted only once.||Null hypothesis was there was no difference between 75 mg AZLI TID and placebo treatment groups in number of participants using additional (nonprotocol-specified) antipseudomonal antibiotics during study.||||>0.999
72494376|NCT03692052|144517750|OTHER||||||<|0.0001|||||||Clopper-Pearson Method|Significance of p-value associated with the test of H0:Hb response rate =0.3 vs H1:Hb response rate \> 0.3.||||||<.0001
72494377|NCT06232317|144517781|SUPERIORITY|||||||0.61|||||||Kruskal-Wallis|||||||0.61
72494378|NCT06232317|144517782|SUPERIORITY|||||||0.014|||||||Kruskal-Wallis|||||||0.014
72494379|NCT06232317|144517787|SUPERIORITY|||||||0.011|||||||Fisher Exact|||||||0.011
72494380|NCT05600309|144517788|OTHER||Hazard Ratio (HR)|0.94||||0.3914|TWO_SIDED|95.0|0.59|1.5||One-sided nominal p-value based on log-rank test.|Log Rank||HR and 95% CI were based on Cox regression model with Efron's method of tie handling with treatment as a covariate.|||1.50|0.59|0.3914
72494381|NCT05600309|144517789|OTHER||Hazard Ratio (HR)|1.23||||0.8091|TWO_SIDED|95.0|0.78|1.92||One-sided nominal p-value based on log-rank test.|Log Rank||HR and 95% CI were based on Cox regression model with Efron's method of tie handling with treatment as a covariate.|||1.92|0.78|0.8091
72494382|NCT05600309|144517790|OTHER||Difference in percentage|6.0||||0.0502|TWO_SIDED|95.0|-2.3|16.3||One-sided nominal p-value for testing.|Miettinen & Nurminen Method||Difference in percentage and 95% CI were based on the Miettinen \& Nurminen method.|||16.3|-2.3|0.0502
72494383|NCT06033079|144517822|SUPERIORITY||Odds Ratio (OR)|0.99|||||TWO_SIDED|95.0|0.32|2.95||||||||2.95|0.32|
72494384|NCT06033079|144517823|SUPERIORITY|||||||0.233|||||||Fisher Exact|||||||0.233
72494385|NCT06033079|144517824|SUPERIORITY||Odds Ratio (OR)|0.86|||||TWO_SIDED|95.0|0.3|2.37||||||||2.37|0.30|
72494386|NCT06033079|144517825|SUPERIORITY||Hazard Ratio (HR)|0.78|||||TWO_SIDED|95.0|0.32|1.82||||||||1.82|0.32|
72494387|NCT06033079|144517826|SUPERIORITY||Odds Ratio (OR)|1.42|||||TWO_SIDED|95.0|0.34|7.51||||||||7.51|0.34|
72494388|NCT06033079|144517827|SUPERIORITY||Hazard Ratio (HR)|0.46|||||TWO_SIDED|95.0|0.13|1.42||||||||1.42|0.13|
72435979|NCT00712166|144384499|SUPERIORITY_OR_OTHER|||||||0.122||||||No adjustments were made for multiple comparisons.|Fisher Exact|A participant with multiple hospitalizations was counted only once.||Null hypothesis was there was no difference between 75 mg AZLI TID and placebo treatment groups in proportion of participants hospitalized.||||0.122
72435980|NCT00712166|144384502|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.21||||0.016|TWO_SIDED|95.0|-2.2|-0.23||No adjustments were made for multiple comparisons.|ANCOVA|ANCOVA model included treatment, baseline log10 CFU, and age group (\<18, \>=18 years). Treatment differences were calculated as AZLI-placebo.||Null hypothesis was there was no difference between 75 mg AZLI TID and placebo treatment groups in change from baseline in the log10 CFU at Day 28.||-0.23|-2.20|0.016
72435981|NCT00712166|144384503|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.73||||0.021|TWO_SIDED|95.0|0.42|5.04||No adjustments were made for multiple comparisons.|ANCOVA|ANCOVA model includes treatment, baseline FEV1 % predicted, and age group (\<18, \>=18 years). Treatment differences were calculated as AZLI-placebo.||Null hypothesis was there was no difference between 75 mg AZLI TID and placebo treatment groups in % change from baseline in FEV1 % predicted at Day 28.||5.04|0.42|0.021
72558154|NCT00928057|144645811|NON_INFERIORITY_OR_EQUIVALENCE|"To conclude equivalence for glycemic control, the average absolute percent change in fructosamine and 95% confidence interval had to be within 20%.~80 subjects were required to be in each insulin dose group (40 per PN arm) to provide 90% power for an equivalence with alpha=0.05."||||||0.506||||||The threshold for statistical significance, or alpha, is 0.05.|ANOVA|The ANOVA model has effects for subject, insulin dose group, investigator site and order of pen needle use.||"The effects of pen needle type on glycemic control were tested for statistical significance using analysis of variance (ANOVA). The ANOVA model was used to calculate the absolute percent (%)change in fructosamine (% \|∆ Fru\|), with 95 % confidence intervals."||||0.506
72558155|NCT00928057|144645811|NON_INFERIORITY_OR_EQUIVALENCE|"To conclude equivalence for glycemic control, the average absolute percent change in fructosamine and 95% confidence interval had to be within 20%.~80 subjects were required to be in each insulin dose group (40 per PN arm) to provide 90% power for an equivalence with alpha=0.05."||||||0.878||||||The threshold for significance, or alpha, is 0.05.|ANOVA|The ANOVA model has effects for subject, insulin dose group, investigator site and order of pen needle use.||"The effects of pen needle type on glycemic control were tested for statistical significance using ANOVA. The ANOVA model was used to calculate the % \|∆ Fru\|, with 95% confidence intervals."||||0.878
72558156|NCT00928057|144645816|SUPERIORITY_OR_OTHER|||||||0.019||||||The threshold for statistical significance, or alpha, is 0.05.|t-test, 1 sided|||The null hypothesis is that the pain from the 4mm is the same or greater than the pain for the reference. The alternative hypothesis is that the pain from the 4mm is less than the pain for the reference.||||0.019
72558157|NCT00928057|144645816|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 1 sided|||As described for the 4 vs. 5mm statistical analysis.||||<0.001
72435982|NCT01875250|144384517|SUPERIORITY|||||||0.74|||||||Wilcoxon rank sum tests|||||||0.74
72435983|NCT05298111|144384564|SUPERIORITY||||||<|0.001|||||||ANCOVA|||||||<0.001
72435984|NCT05298111|144384565|SUPERIORITY||||||<|0.001|||||||Paired t-test|||||||< 0.001
72435985|NCT05298111|144384566|SUPERIORITY||||||<|0.001|||||||Sign test|||||||< 0.001
72435986|NCT05298111|144384567|SUPERIORITY|||||||0.001|||||||Sign test|||||||0.001
72435987|NCT05298111|144384568|SUPERIORITY|||||||0.894|||||||Paired t-test|||||||0.894
72435988|NCT05298111|144384569|SUPERIORITY|||||||0.629|||||||Paired t-test|||||||0.629
72435989|NCT05298111|144384570|SUPERIORITY|||||||0.653|||||||Paired t-test|||||||0.653
72435990|NCT05298111|144384571|SUPERIORITY|||||||0.624|||||||Paired t-test|||||||0.624
72435991|NCT05298111|144384572|SUPERIORITY|||||||0.414|||||||Paired t-test|||||||0.414
72435992|NCT05298111|144384573|SUPERIORITY|||||||0.105|||||||Paired t-test|||||||0.105
72435993|NCT01616654|144384613|SUPERIORITY||Percentage difference|13.115||||0.096|TWO_SIDED|95.0|-3.266|29.495|||Cochran-Mantel-Haenszel|||The 95% confidence interval on the difference between Vehicle and the specified treatment group success rates was based on normal approximation with continuity correction.||29.495|-3.266|0.096
72435994|NCT01616654|144384613|SUPERIORITY||Percentage difference|16.393||||0.04|TWO_SIDED|95.0|-0.249|33.036|||Cochran-Mantel-Haenszel|||The 95% confidence interval on the difference between Vehicle and the specified treatment group success rates was based on normal approximation with continuity correction||33.036|-0.249|0.040
72435995|NCT01616654|144384613|SUPERIORITY||Percentage difference|10.273||||0.184|TWO_SIDED|95.0|-5.923|26.47|||Cochran-Mantel-Haenszel|||The 95% confidence interval on the difference between Vehicle and the specified treatment group success rates was based on normal approximation with continuity correction.||26.470|-5.923|0.184
72435996|NCT01616654|144384613|SUPERIORITY||Percentage difference|16.393||||0.041|TWO_SIDED|95.0|-0.249|33.036|||Cochran-Mantel-Haenszel|||The 95% confidence interval on the difference between Vehicle and the specified treatment group success rates was based on normal approximation with continuity correction.||33.036|-0.249|0.041
72435997|NCT01616654|144384614|SUPERIORITY||Percentage difference|-6.74||||0.108|TWO_SIDED|95.0|-14.96|1.48|||ANCOVA|||Analysis was performed using analysis of covariance (ANCOVA) with terms for treatment, stratum, and Baseline lesion count as covariate.||1.48|-14.96|0.108
72435998|NCT01616654|144384614|SUPERIORITY||Percentage difference|-7.88||||0.06|TWO_SIDED|95.0|-16.11|0.34|||ANCOVA|||Analysis was performed using analysis of covariance (ANCOVA) with terms for treatment, stratum, and Baseline lesion count as covariate.||0.34|-16.11|0.060
72435999|NCT01616654|144384614|SUPERIORITY||Percentage difference|-8.11||||0.054|TWO_SIDED|95.0|-16.35|0.13|||ANCOVA|||Analysis was performed using ANCOVA with terms for treatment, stratum, treatment stratum, and with Baseline lesion count as covariate.||0.13|-16.35|0.054
72436000|NCT01616654|144384614|SUPERIORITY||Percentage difference|-12.97||||0.002|TWO_SIDED|95.0|-21.18|-4.76|||ANCOVA|||Analysis was performed using ANCOVA with terms for treatment, stratum, treatment stratum, and with Baseline lesion count as covariate.||-4.76|-21.18|0.002
72436001|NCT01616654|144384615|SUPERIORITY|||||||0.067|||||||Cochran-Mantel-Haenszel|||||||0.067
72436002|NCT01616654|144384615|SUPERIORITY|||||||0.054|||||||Cochran-Mantel-Haenszel|||||||0.054
72436003|NCT01616654|144384615|SUPERIORITY|||||||0.038|||||||Cochran-Mantel-Haenszel|||||||0.038
72558158|NCT05497557|144645823|OTHER|Drug-drug Interaction Assessment|Ratio of geometric least squares mean|0.677|||||TWO_SIDED|90.0|0.547|0.839||||||Ratios of geometric least squares means, and corresponding confidence intervals were obtained by taking the exponential of the least square means (LSMs), differences in LSMs, and corresponding confidence intervals on the natural log (ln) scale.||0.839|0.547|
72494389|NCT06033079|144517828|SUPERIORITY||Odds Ratio (OR)|1.72|||||TWO_SIDED|95.0|0.41|7.9||||||||7.90|0.41|
72494390|NCT03505021|144517841|SUPERIORITY||Mean Difference (Final Values)|0.258||||0.8253|TWO_SIDED|95.0|-2.032|2.547|||ANCOVA|||||2.547|-2.032|0.8253
72494391|NCT03505021|144517842|SUPERIORITY||Mean Difference (Final Values)|10.69||||0.4277|TWO_SIDED|95.0|-15.74|37.12|||ANCOVA|||||37.12|-15.74|0.4277
72494392|NCT03505021|144517843|SUPERIORITY||Hazard Ratio (HR)|1.051||||0.6733|TWO_SIDED|95.0|0.833|1.327|||Regression, Cox|||||1.327|0.833|0.6733
72494393|NCT03505021|144517844|SUPERIORITY||Mean Difference (Final Values)|3.762||||0.1295|TWO_SIDED|95.0|-1.129|8.654|||ANCOVA|||||8.654|-1.129|0.1295
72494394|NCT03505021|144517845|SUPERIORITY||Mean Difference (Final Values)|0.013||||0.623|TWO_SIDED|95.0|-0.04|0.066|||Mixed Models Analysis|||||0.066|-0.040|0.6230
72494395|NCT03505021|144517846|SUPERIORITY||Mean Difference (Final Values)|-0.272||||0.1752|TWO_SIDED|95.0|-0.666|0.122|||ANCOVA|||||0.122|-0.666|0.1752
72494396|NCT02392429|144517859|NON_INFERIORITY|we tested the null hypothesis that the NPV of the post-treatment FLT PET/CT scan was less than or equal to the NPV of the day 14 nadir bone marrow biopsy (estimated to be 0.64 by Hussein et al) against the one-sided alternative hypothesis that the NPV was greater than 0.64 using the exact binomial test.|||||>|0.99|||||||binomial exact test|||||||>0.99
72558159|NCT05497557|144645824|OTHER|Drug-drug Interaction Assessment|Ratio of geometric least squares mean|0.771|||||TWO_SIDED|90.0|0.628|0.948||||||Ratios of geometric least squares means, and corresponding confidence intervals were obtained by taking the exponential of the least square means (LSMs), differences in LSMs, and corresponding confidence intervals on the natural log (ln) scale.||0.948|0.628|
72383839|NCT01675427|144275949|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Pearson Chi-Square Tests for association between the two variables|Chi-squared|||||||< 0.0001
72494397|NCT02392429|144517860|NON_INFERIORITY|we tested the null hypothesis that the PPV of the post-treatment FLT PET/CT scan was less than or equal to the PPV of the day 14 nadir bone marrow biopsy (estimated to be 0.79by Hussein et al) against the one-sided alternative hypothesis that the PPV was greater than 0.79 using the exact binomial test.||||||0.06|||||||binomial exact test|||||||0.06
72494398|NCT02392429|144517864|EQUIVALENCE|no margin was assumed||||||0.68|||||||log-rank test|||Kaplan-Meier curves were constructed for the positive and negative scan groups, and the null hypothesis that the survival distributions of the two groups were equal was tested using the log-rank test.||||0.68
72383840|NCT01675427|144275950|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G1||||< 0.0001
72383841|NCT01675427|144275950|SUPERIORITY_OR_OTHER|||||||0.2887|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G2||||0.2887
72383842|NCT01675427|144275950|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G3||||< 0.0001
72383843|NCT01675427|144275950|SUPERIORITY_OR_OTHER|||||||0.1634|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G4||||0.1634
72383844|NCT01675427|144275950|SUPERIORITY_OR_OTHER|||||||0.8956|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Other genotypes||||0.8956
72383845|NCT01675427|144275950|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Total genotypes||||< 0.0001
72383846|NCT01675427|144275951|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G1||||< 0.0001
72383847|NCT01675427|144275951|SUPERIORITY_OR_OTHER|||||||0.0145|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G2||||0.0145
72383848|NCT01675427|144275951|SUPERIORITY_OR_OTHER|||||||0.1027|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G3||||0.1027
72383849|NCT01675427|144275951|SUPERIORITY_OR_OTHER|||||||0.5998|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G4||||0.5998
72383850|NCT01675427|144275951|SUPERIORITY_OR_OTHER|||||||0.2935|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Other genotypes||||0.2935
72383851|NCT01675427|144275951|SUPERIORITY_OR_OTHER|||||||0.0039|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Total genotypes||||0.0039
72383852|NCT01675427|144275952|SUPERIORITY_OR_OTHER|||||||0.1981|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G1||||0.1981
72383853|NCT01675427|144275952|SUPERIORITY_OR_OTHER|||||||0.1616|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G2||||0.1616
72383854|NCT01675427|144275952|SUPERIORITY_OR_OTHER|||||||0.1192|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G3||||0.1192
72383855|NCT01675427|144275952|SUPERIORITY_OR_OTHER|||||||0.4485|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G4||||0.4485
72383856|NCT01675427|144275952|SUPERIORITY_OR_OTHER|||||||0.1525|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Other genotypes||||0.1525
72383857|NCT01675427|144275952|SUPERIORITY_OR_OTHER|||||||0.7262|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Total genotypes||||0.7262
72436004|NCT01616654|144384615|SUPERIORITY|||||||0.003|||||||Cochran-Mantel-Haenszel|||||||0.003
72436005|NCT00286741|144384623|SUPERIORITY_OR_OTHER|||||||0.15|||||||Mixed Models Analysis|||||||0.15
72436006|NCT00286741|144384624|SUPERIORITY_OR_OTHER|||||||0.03|||||||Mixed Models Analysis|||||||0.03
72436007|NCT02057692|144384626|SUPERIORITY||LS mean difference|-0.889|STANDARD_ERROR_OF_MEAN|0.3969||0.0321|TWO_SIDED|95.0|-1.698|0.081|||ANCOVA|||The primary analysis of change from baseline to endpoint (Week 13/ET) average daily ItchRO(Obs) was evaluated by analysis of covariance (ANCOVA) using a PROC MIXED procedure. Least-squares (LS) mean change from baseline to Endpoint (Week 13/ET), along with associated 95% confidence interval (CI) for the LS mean, and pair-wise treatment P-values were calculated for each treatment group.||0.081|-1.698|0.0321
72436008|NCT02057692|144384626|SUPERIORITY||LS mean difference|-0.906|STANDARD_ERROR_OF_MEAN|0.3503||0.0145|TWO_SIDED|95.0|-1.62|-0.192|||ANCOVA|||The primary analysis of change from baseline to endpoint (Week 13/ET) average daily ItchRO(Obs) was evaluated by ANCOVA using a PROC MIXED procedure. LS mean change from baseline to Endpoint (Week 13/ET), along with associated 95% CI for the LS mean, and pair-wise treatment P-values were calculated for each treatment group.||-0.192|-1.620|0.0145
72436009|NCT02057692|144384626|SUPERIORITY||LS mean difference|-0.039|STANDARD_ERROR_OF_MEAN|0.4431||0.9298|TWO_SIDED|95.0|-0.942|0.863|||ANCOVA|||The primary analysis of change from baseline to endpoint (Week 13/ET) average daily ItchRO(Obs) was evaluated by ANCOVA using a PROC MIXED procedure. LS mean change from baseline to Endpoint (Week 13/ET), along with associated 95% confidence interval (CI) for the LS mean, and pair-wise treatment P-values were calculated for each treatment group.||0.863|-0.942|0.9298
72436010|NCT00864682|144384631|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||Kruskal-Wallis|||Hypothesis: Lidocaine / propofol admixture would be superior to lidocaine pretreatment for attenuating propofol-induced injection pain. Sample size calculated to detect a difference of at least 2 VPS points; beta 0.8.||||<0.0001
72436011|NCT00864682|144384632|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.008||95.0|||||Chi-squared|Fisher's exact test after chi-squared||||||<0.008
72436012|NCT00545844|144384635|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
72436013|NCT00545844|144384636|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
72494399|NCT02392429|144517865|EQUIVALENCE|no margin was assumed||||||0.08|||||||log-rank test|||Kaplan-Meier curves were constructed for the positive and negative scan groups, and the null hypothesis that the survival distributions of the two groups were equal was tested using the log-rank test.||||0.08
72494400|NCT06523491|144517866|SUPERIORITY||F value|23.31||||0|TWO_SIDED|||||The threshold for statistical significance was p \<0.05.|ANCOVA|"To compare the efficacy of 1 and 2 NOLTREX courses with placebo was used ANCOVA adjusted for the baseline value with fixed factor of treatment group"||No sample size calculation was performed. In the survey took part 57 patients from the parent study and OLE. The study did not have a formal hypothesis. The between-group comparison of changes from baseline (OLE visit 0) in the WOMAC-T at the end of 12-month follow-up (EOF) visit was conducted using analysis of covariance (ANCOVA) and, as a post hoc test, the Tukey test.||||0.00
72436014|NCT00545844|144384637|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||McNemar-Bowker|||McNemar-Bowker test is McNemar chi-squared statistic for binary matched pairs, with Bowker chi-squared fit test of symmetry model (tests all rows of data) (cf. Agresti, 2007)||||<0.001
72436015|NCT00545844|144384638|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||McNemar-Bowker|||McNemar-Bowker test is McNemar chi-squared statistic for binary matched pairs, with Bowker chi-squared fit test of symmetry model (tests all rows of data) (cf. Agresti, 2007)||||<0.001
72436016|NCT00545844|144384639|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||McNemar-Bowker|||McNemar-Bowker test is McNemar chi-squared statistic for binary matched pairs, with Bowker chi-squared fit test of symmetry model (tests all rows of data) (cf. Agresti, 2007)||||<0.001
72436017|NCT00957658|144384640|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin = 6%|||||<|0.0001|||||||Asymptotic WALD test|||Literature control = 96% with no aseptic loosening, intraop femoral fracture or thigh pain at 2 years||||<.0001
72436018|NCT00957658|144384643|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Sign test|||Improvement from preop to 2 year and preop to 5 year||||<.0001
72436019|NCT00957658|144384644|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||Compare Pre-op SF-12 Physical Score preop to 2 year and preop to 5 year||||<.0001
72436020|NCT00957658|144384644|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Sign test|||Change in SF-12 Mental Score preop to 2 years||||<.0001
72436021|NCT00957658|144384644|SUPERIORITY_OR_OTHER|||||||0.0004|||||||t-test, 2 sided|||Compare SF-12 Mental Score preop to 5 years||||.0004
72436022|NCT00957658|144384645|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Sign test|||Compare LEAS score preop to 2 years and preop to 5 years||||<.0001
72494401|NCT06523491|144517866|SUPERIORITY||LS-means difference|353.18|STANDARD_ERROR_OF_MEAN|72.27||0|TWO_SIDED|95.0|178.91|527.45||Difference between Least-square means was tested at a level of p \<0.05 via Tukey's multiple comparison test.|Tukey's HSD|||Post-hoc pairwise comparisons were performed using Tukey test.||527.45|178.91|0.00
72436023|NCT00957658|144384648|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||Compare to historical control (n=94 hips): mean wear 5 years = 0.134 (0.078)||||<.0001
72436024|NCT00957658|144384649|SUPERIORITY_OR_OTHER|||||||0.0002|||||||Sign test|||Compare Wrist DXA T-score preop to 5 years||||.0002
72436025|NCT03525119|144384698|NON_INFERIORITY|As per predefined criteria in protocol the non-inferiority was established only between group 1 and group 3. Non-inferiority of HAV+TDV to HAV was established if the upper bound of the 95% CI was less than 10%.|Seroprotection Rate Difference|-1.68|||||TWO_SIDED|95.0|-8.91|4.28||||||||4.28|-8.91|
72436026|NCT00208507|144384713|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|This was a non-inferiority test of the Harris Hip Score means at 24+ months with a 5 point non-inferiority margin.|Mean Difference (Final Values)|0.61||||0.001|ONE_SIDED|95.0|-1.56||||ANCOVA|Preoperative Harris Hip score was included in the ANCOVA model as the only covariate.|||||-1.56|0.001
72436027|NCT01183780|144384717|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.844||||0.0219|TWO_SIDED|95.0|0.73|0.976|||Log Rank|The analysis was performed on stratified data.|The estimation was performed on stratified data.|||0.976|0.730|0.0219
72436028|NCT01183780|144384718|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.793||||0.0005|TWO_SIDED|95.0|0.697|0.903|||Log Rank|Analysis was performed on stratified data.|Analysis was performed on stratified data.|||0.903|0.697|0.0005
72436029|NCT01183780|144384719|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6336|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.6336
72436030|NCT00982033|144384724|SUPERIORITY_OR_OTHER|||||||0.9|||||||ANCOVA|||||||0.90
72436031|NCT02613364|144384758|NON_INFERIORITY|Non-inferiority is established if the difference in mean change on the ISI between YOCAS©® and CBT-I is less than 1.15. Using ANCOVA to estimate differences in mean change between YOCAS©® and CBT-I, a correlation of 0.576 (from our prior study), and a sample of 168 subjects per group, we will have sufficient (80%) power to detect non-inferiority using a margin of 1.15 at p = 0.025.|Mean Difference (Final Values)|3.52|STANDARD_ERROR_OF_MEAN|0.43|<|0.0001|TWO_SIDED|95.0|2.66|4.37||The p-value shown above is from the Least Squares Mean between YOCAS - CBT-I from the Mixed Model.|Mixed Models Analysis||The comparison is YOCAS - CBT-I|Constructed a 95% confidence interval on the mean change of ISI from baseline between the arms (YOCAS - CBT-I). If the lower bound of the interval is less than 1.5 then we conclude that YOCAS is non-inferior.||4.37|2.66|<.0001
72436032|NCT02613364|144384759|SUPERIORITY|Using ANCOVA to estimate differences in mean change between YOCAS and health education, a correlation of 0.576 (from our prior study), and a sample size of 168 evaluable subjects per group, we will have sufficient power to detect differences on the ISI of at least 1.3, 1.5 and 1.6 (all larger than our 1.15 non-inferiority margin) at 80%, 90%, and 95% power, respectively|Mean Difference (Final Values)|-1.4|STANDARD_ERROR_OF_MEAN|0.42||0.0009|TWO_SIDED|95.0|-2.23|-0.58||the comparison of YOCAS to the health education control is a traditional null hypothesis of no difference with a two-sided alpha. The p-value shown is from the Least Squares Mean (YOCAS - Health Education) generated from the Mixed Model.|Mixed Models Analysis||The comparison is from the ISI Least Squares Mean difference (YOCAS - Health Education) generated from the Mixed Model.|The comparison of YOCAS to the health education control is a traditional null hypothesis of no difference with a two-sided alpha.||-0.58|-2.23|0.0009
72494402|NCT06523491|144517866|SUPERIORITY||LS-means difference|-292.19|STANDARD_ERROR_OF_MEAN|78.04||0|TWO_SIDED|95.0|-480.37|-104.01||Difference between Least-square means was tested at a level of p \<0.05 via Tukey's multiple comparison test.|Tukey's HSD|||Post-hoc pairwise comparisons were performed using Tukey test.||-104.01|-480.37|0.00
72494403|NCT06523491|144517866|SUPERIORITY||LS-means difference|-645.37|STANDARD_ERROR_OF_MEAN|95.68||0|TWO_SIDED|95.0|-876.07|-414.67||Difference between Least-square means was tested at a level of p \<0.05 via Tukey's multiple comparison test.|Tukey's HSD|||Post-hoc pairwise comparisons were performed using Tukey test.||-414.67|-876.07|0.00
72494404|NCT06523491|144517866|SUPERIORITY||F value|23.31||||0|TWO_SIDED|||||The threshold for statistical significance was p \<0.05.|ANCOVA|"To compare the efficacy of 1 and 2 NOLTREX courses with placebo was used ANCOVA adjusted for the baseline value with fixed factor of treatment group"||The between-group comparison of changes from baseline (study 1 visit 1) in the WOMAC-T at visit 5 was conducted using analysis of covariance (ANCOVA) and, as a post hoc test, the Tukey test.||||0.00
72494405|NCT06523491|144517866|SUPERIORITY||LS-means difference|-292.19|STANDARD_ERROR_OF_MEAN|78.04||0|TWO_SIDED|95.0|-480.37|-104.01|||Tukey's HSD|||Post-hoc pairwise comparisons were performed using Tukey test.||-104.01|-480.37|0.00
72494406|NCT06523491|144517866|SUPERIORITY||[LS-means difference|-645.37|STANDARD_ERROR_OF_MEAN|95.68||0|TWO_SIDED|95.0|-876.07|-414.67||Difference between Least-square means was tested at a level of p \<0.05 via Tukey's multiple comparison test.|Tukey's HSD|||Post-hoc pairwise comparisons were performed using Tukey test.||-414.67|-876.07|0.00
72494407|NCT03266016|144517871|SUPERIORITY||Odds Ratio (OR)|1.67||||0.045|TWO_SIDED|95.0|1.01|2.77|||Proportional Odds Logistic Regression|||This analysis is comparing length of weaning between REDvent acute group and control acute group.||2.77|1.01|.045
72494408|NCT03266016|144517871|SUPERIORITY||Proportional odds logistic regression|1.3|||||TWO_SIDED|95.0|0.7|2.6||||||Weaning Phase||2.6|0.7|
72494409|NCT03266016|144517872|SUPERIORITY||Incident rate ratio|1.03|||||TWO_SIDED|95.0|0.84|1.25|||||Negative binomial model.|||1.25|0.84|
72494410|NCT03266016|144517873|SUPERIORITY||Odds Ratio (OR)|1.0|||||TWO_SIDED|95.0|0.4|2.7||||||||2.7|0.4|
72494411|NCT03266016|144517874|SUPERIORITY||Odds Ratio (OR)|1.04|||||TWO_SIDED|95.0|0.44|2.47||||||||2.47|0.44|
72494412|NCT03266016|144517875|SUPERIORITY||Proportional odds logistic regression|1.6|||||TWO_SIDED|95.0|1.01|2.55||||||||2.55|1.01|
72494413|NCT04183335|144517900|SUPERIORITY||Odds Ratio (OR)|6.5|||<|0.0001|TWO_SIDED|95.0|2.78|15.41||Threshold of significance at 0.05.|Cochran-Mantel-Haenszel||Dupilumab 300 mg Q2W versus Placebo|A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measures are reported and continued when primary outcome measure was statistically significant at two-sided 0.05.||15.41|2.78|<0.0001
72494414|NCT04183335|144517901|SUPERIORITY||Odds Ratio (OR)|4.0||||0.0004|TWO_SIDED|95.0|1.81|8.98||Threshold of significance at 0.05.|Cochran-Mantel-Haenszel||Dupilumab 300 mg Q2W versus Placebo|A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measures are reported and continued when previous outcome measure was statistically significant at two-sided 0.05.||8.98|1.81|0.0004
72494415|NCT04183335|144517902|SUPERIORITY||Odds Ratio (OR)|6.9|||<|0.0001|TWO_SIDED|95.0|2.49|19.05||Threshold of significance at 0.05.|Cochran-Mantel-Haenszel||Dupilumab 300 mg Q2W versus Placebo|A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measures are reported and continued when previous outcome measure was statistically significant at two-sided 0.05.||19.05|2.49|<0.0001
72494416|NCT04183335|144517903|SUPERIORITY||LS mean difference|-26.67|||<|0.0001|TWO_SIDED|95.0|-38.44|-14.9||Threshold of significance at 0.05.|ANCOVA||Dupilumab 300 mg Q2W versus Placebo|A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measures are reported and continued when previous outcome measure was statistically significant at two-sided 0.05.||-14.90|-38.44|<0.0001
72558160|NCT05497557|144645825|OTHER|Drug-drug Interaction Assessment|Ratio of geometric least squares mean|0.766|||||TWO_SIDED|90.0|0.619|0.948||||||Ratios of geometric least squares means, and corresponding confidence intervals were obtained by taking the exponential of the least square means (LSMs), differences in LSMs, and corresponding confidence intervals on the natural log (ln) scale.||0.948|0.619|
72558161|NCT02752074|144645827|OTHER||Hazard Ratio (HR)|1.0||||0.51711|TWO_SIDED|95.0|0.83|1.21||One-sided p-value based on log-rank test.|Log Rank|||||1.21|0.83|0.51711
72558162|NCT02752074|144645828|OTHER||Hazard Ratio (HR)|1.13||||0.80666|TWO_SIDED|95.0|0.86|1.49||One-sided p-value based on log-rank test.|Log Rank|||||1.49|0.86|0.80666
72558163|NCT00907907|144645841|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of Variance (PROC MIXED) were performed on the log-transformed AUCt, AUCinf and Cmax parameters.|Geometric Test/Ref Ratio x 100|93.97||||||90.0|80.25|110.04|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||110.04|80.25|
72558164|NCT00907907|144645842|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analyses of Variance (PROC MIXED) were performed on the log-transformed AUCt, AUCinf and Cmax parameters.|Geometric Test/Ref Ratio x 100|102.01||||||90.0|98.74|105.39|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||105.39|98.74|
72558165|NCT00907907|144645843|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analyses of Variance (PROC MIXED) were performed on the log-transformed AUCt, AUCinf and Cmax parameters.|Geometric Test/Ref Ratio x 100|99.91||||||90.0|95.99|103.98|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||103.98|95.99|
72558166|NCT00545792|144645845|SUPERIORITY_OR_OTHER||Single point estiamte of 1-yr PFS|0.8|||||TWO_SIDED|95.0|0.56|0.94|||||The reported 1-year PFS rate 80% (Exact 95% CI: 56% - 94%) was the proportion of the patients remained progression free after 12 months.|Single-arm feasibility study; Kaplan Meier analysis was applied to estimate one-year PFS distribution as well as to calculate proportion of patients remain progression free by month 12.||0.94|0.56|
72558167|NCT06078501|144645858|OTHER|||||||0.695||||||The a priori threshold for statistical significance was \<0.05.|Mann-Whitney U test|||||||0.695
72558168|NCT06078501|144645859|OTHER|||||||0.91|||||||Mann-Whitney U test|The a priori threshold for statistical significance was \<0.05.||||||0.91
72558169|NCT06078501|144645860|OTHER|||||||1||||||The a priori threshold for statistical significance was \<0.05.|Fisher Exact|||||||1.0
72558170|NCT06078501|144645861|OTHER|||||||1||||||The a priori threshold for statistical significance was \<0.05.|Fisher Exact|||||||1.0
72383858|NCT01675427|144275953|SUPERIORITY_OR_OTHER|||||||0.0911|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G1||||0.0911
72383859|NCT01675427|144275953|SUPERIORITY_OR_OTHER|||||||0.4674|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G2||||0.4674
72383860|NCT01675427|144275953|SUPERIORITY_OR_OTHER|||||||0.1604|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G3||||0.1604
72383861|NCT01675427|144275953|SUPERIORITY_OR_OTHER|||||||0.5937|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G4||||0.5937
72383862|NCT01675427|144275953|SUPERIORITY_OR_OTHER|||||||0.383|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Other genotypes||||0.3830
72383863|NCT01675427|144275953|SUPERIORITY_OR_OTHER|||||||0.0507|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Total genotypes||||0.0507
72383864|NCT01675427|144275954|SUPERIORITY_OR_OTHER|||||||0.8686|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G1||||0.8686
72558171|NCT06078501|144645862|OTHER|||||||0.887||||||The a priori threshold for statistical significance was \<0.05.|Mann-Whitney U test|||||||0.887
72558172|NCT06078501|144645863|OTHER|||||||0.887||||||The a priori threshold for statistical significance was \<0.05.|Mann-Whitney U test|||||||0.887
72558173|NCT06078501|144645865|OTHER|||||||1|||||||Fisher Exact|||||||1.0
72558174|NCT06078501|144645866|OTHER|||||||1||||||The a priori threshold for statistical significance was \<0.05.|Mann-Whitney U test|||||||1.0
72558175|NCT06078501|144645867|OTHER|||||||1|||||||Fisher Exact|||||||1.0
72558176|NCT03428750|144645896|SUPERIORITY|||||||0.006|||||||Cochran-Mantel-Haenszel|Adjusted for analysis center||CCH 0.84 mg/Buttock versus Placebo||||0.006
72558177|NCT03428750|144645897|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|Adjusted for analysis center||CCH 0.84 mg/Buttock versus Placebo||||<0.001
72558178|NCT03428750|144645898|SUPERIORITY|||||||0.001|||||||Cochran-Mantel-Haenszel|Adjusted for analysis center||CCH 0.84 mg/Buttock versus Placebo||||0.001
72558179|NCT03428750|144645899|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|Adjusted for analysis center||CCH 0.84 mg/Buttock versus Placebo||||<0.001
72558180|NCT03428750|144645900|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|Adjusted for analysis center||CCH 0.84 mg/Buttock versus Placebo||||<0.001
72558181|NCT03428750|144645901|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|Adjusted for analysis center||CCH 0.84 mg/Buttock versus Placebo||||<0.001
72558182|NCT03428750|144645902|SUPERIORITY||||||<|0.001|||||||ANCOVA|With factors of treatment group and analysis center adjusted for baseline values in the model||CCH 0.84 mg/Buttock versus Placebo||||<0.001
72558183|NCT03428750|144645903|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|Adjusted for analysis center||CCH 0.84 mg/Buttock versus Placebo||||<0.001
72558184|NCT03428750|144645904|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|Adjusted for analysis center||CCH 0.84 mg/Buttock versus Placebo||||<0.001
72618746|NCT01026038|144768109|SUPERIORITY_OR_OTHER||GMT ratio|0.6|||||TWO_SIDED|95.0|0.45|0.87||||||Serotype 5: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||0.87|0.45|
72618747|NCT01026038|144768109|SUPERIORITY_OR_OTHER||GMT ratio|0.5|||||TWO_SIDED|95.0|0.36|0.79||||||Serotype 5: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||0.79|0.36|
72558185|NCT01919112|144645920|OTHER|Regression models using interaction terms will used to assess for heterogeneity of intervention effects across the novel radiological variable corticobulbar tract (CBT)-lesion load, a combined measure of lesion size and location. For purposes of the analysis, the CBT-lesion load was dichotomized into 2 groups based on the median CBT-lesion load volume.||||||0.116||||||Interaction p-values will be considered statistically significant at the 0.15 level of significance given the relatively low power for tests of interaction to detect a true interaction.|2-way analysis of variance with interact|The tDCS intervention was the main variable of interest, PAS score the main outcome and CBT-lesion load was the interaction term used.||The aim for this analysis was to assess for effect modification of the trial intervention across the novel radiological variable corticobulbar tract-lesion load.||||0.116
72558186|NCT02554877|144645921|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|-0.91|STANDARD_ERROR_OF_MEAN|0.16|<|0.0001|TWO_SIDED|95.0|-1.34|-0.48||Two (2)-sided p-values were from mixed model for repeated measurements (MMRM) with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 12||-0.48|-1.34|<0.0001
72558187|NCT02554877|144645921|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|-1.16|STANDARD_ERROR_OF_MEAN|0.16|<|0.0001|TWO_SIDED|95.0|-1.59|-0.73||Two (2)-sided p-values were from mixed model for repeated measurements (MMRM) with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 12||-0.73|-1.59|<0.0001
72558188|NCT02554877|144645921|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|-1.17|STANDARD_ERROR_OF_MEAN|0.16|<|0.0001|TWO_SIDED|95.0|-1.6|-0.74||Two (2)-sided p-values were from mixed model for repeated measurements (MMRM) with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 12.||-0.74|-1.60|<0.0001
72558189|NCT02554877|144645922|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|-0.39|STANDARD_ERROR_OF_MEAN|0.07|<|0.0001|TWO_SIDED|95.0|-0.52|-0.26||Two (2)-sided p-values were from analysis of covariance (ANCOVA) model with baseline value and treatment group as fixed effects|ANCOVA|Least squares mean (LS mean) difference from placebo adjusted for baseline values was derived from the ANCOVA model||Placebo was the reference and each of the active doses was the test for Week 2.||-0.26|-0.52|<0.0001
72558190|NCT02554877|144645922|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|-0.39|STANDARD_ERROR_OF_MEAN|0.07|<|0.0001|TWO_SIDED|95.0|-0.52|-0.26||Two (2)-sided p-values were from analysis of covariance (ANCOVA) model with baseline value and treatment group as fixed effects|ANCOVA|LS mean difference from placebo adjusted for baseline values was derived from the ANCOVA model.||Placebo was the reference and each of the active doses was the test for Week 2.||-0.26|-0.52|<0.0001
72383865|NCT01675427|144275954|SUPERIORITY_OR_OTHER|||||||0.3135|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G2||||0.3135
72383866|NCT01675427|144275954|SUPERIORITY_OR_OTHER|||||||0.0578|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G3||||0.0578
72383867|NCT01675427|144275954|SUPERIORITY_OR_OTHER|||||||0.5833|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G4||||0.5833
72383868|NCT01675427|144275954|SUPERIORITY_OR_OTHER|||||||0.161|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Other genotypes||||0.1610
72558191|NCT02554877|144645922|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|-0.44|STANDARD_ERROR_OF_MEAN|0.07|<|0.0001|TWO_SIDED|95.0|-0.57|-0.3||Two (2)-sided p-values were from analysis of covariance (ANCOVA) model with baseline value and treatment group as fixed effects.|ANCOVA|LS mean difference from placebo adjusted for baseline values was derived from the ANCOVA model.||Placebo was the reference and each of the active doses was the test for Week 2.||-0.30|-0.57|<0.0001
72558192|NCT02554877|144645922|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|-0.59|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001|TWO_SIDED|95.0|-0.76|-0.42||Two (2)-sided p-values were from analysis of covariance (ANCOVA) model with baseline value and treatment group as fixed effects.|ANCOVA|LS mean difference from placebo adjusted for baseline values was derived from the ANCOVA model.||Placebo was the reference and each of the active doses was the test for Week 4.||-0.42|-0.76|<0.0001
72383869|NCT01675427|144275954|SUPERIORITY_OR_OTHER|||||||0.2925|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Total genotypes||||0.2925
72383870|NCT01675427|144275955|SUPERIORITY_OR_OTHER|||||||0.3709|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G1||||0.3709
72383871|NCT01675427|144275955|SUPERIORITY_OR_OTHER|||||||0.2054|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G2||||0.2054
72383872|NCT01675427|144275955|SUPERIORITY_OR_OTHER|||||||0.8457|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G3||||0.8457
72383873|NCT01675427|144275955|SUPERIORITY_OR_OTHER|||||||0.3492|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G4||||0.3492
72383874|NCT01675427|144275955|SUPERIORITY_OR_OTHER|||||||0.2846|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Other genotypes||||0.2846
72383875|NCT01675427|144275955|SUPERIORITY_OR_OTHER|||||||0.2646|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Total genotypes||||0.2646
72383876|NCT01675427|144275956|SUPERIORITY_OR_OTHER|||||||0.5348|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G1||||0.5348
72383877|NCT01675427|144275956|SUPERIORITY_OR_OTHER|||||||0.5469|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G2||||0.5469
72436033|NCT02613364|144384760|EQUIVALENCE|The null hypothesis is that the mean change in the outcome measure between the two arms is zero.|Mean Difference (Final Values)|-0.47|STANDARD_ERROR_OF_MEAN|0.26||0.07|TWO_SIDED|95.0|-0.98|0.04||The comparison of YOCAS to the health education control is a traditional null hypothesis of no difference with a two-sided alpha. The p-value shown is from the Least Squares Mean (YOCAS - Health Education) generated from the Mixed Model.|Mixed Models Analysis||The comparison is from the ISI Least Squares Mean difference (YOCAS - Health Education) generated from the Mixed Model.|The comparison of YOCAS to the health education control is a traditional null hypothesis of no difference with a two-sided alpha.||0.04|-0.98|0.0700
72436034|NCT02613364|144384761|EQUIVALENCE|The null hypothesis is that the mean change in the outcome measure between the two arms is zero.|Mean Difference (Final Values)|2.23|STANDARD_ERROR_OF_MEAN|0.27|<|0.0001|TWO_SIDED|95.0|1.7|2.75||The comparison of YOCAS to CBT-I is a traditional null hypothesis of no difference with a two-sided alpha. The p-value shown is from the Least Squares Mean (YOCAS - CBT-I) generated from the Mixed Model.|Mixed Models Analysis||The comparison is from the ISI Least Squares Mean difference (YOCAS - CBT-I) generated from the Mixed Model.|The comparison of YOCAS to CBT-I is a traditional null hypothesis of no difference with a two-sided alpha.||2.75|1.70|<.0001
72436035|NCT02613364|144384762|EQUIVALENCE|The null hypothesis is that the mean change in the outcome measure between the two arms is zero.|Mean Difference (Final Values)|19.73|STANDARD_ERROR_OF_MEAN|7.03||0.0052|TWO_SIDED|95.0|5.91|33.54||The comparison of YOCAS to the health education control is a traditional null hypothesis of no difference with a two-sided alpha. The p-value shown is from the Least Squares Mean (YOCAS - Health Education) generated from the Mixed Model.|Mixed Models Analysis||The comparison is from the Least Squares Mean difference (YOCAS - Health Education) generated from the Mixed Model.|The comparison of YOCAS to the health education control is a traditional null hypothesis of no difference with a two-sided alpha.||33.54|5.91|0.0052
72436036|NCT02613364|144384763|EQUIVALENCE|The null hypothesis is that the mean change in the outcome measure between the two arms is zero.|Mean Difference (Final Values)|15.94|STANDARD_ERROR_OF_MEAN|7.12||0.0258|TWO_SIDED|95.0|1.93|29.94||The comparison of YOCAS to CBT-I is a traditional null hypothesis of no difference with a two-sided alpha. The p-value shown is from the Least Squares Mean (YOCAS - CBT-I) generated from the Mixed Model.|Mixed Models Analysis|||||29.94|1.93|0.0258
72436037|NCT02613364|144384764|EQUIVALENCE|The null hypothesis is that the mean change in the outcome measure between the two arms is zero.|Mean Difference (Final Values)|-0.002|STANDARD_ERROR_OF_MEAN|0.025||0.92|TWO_SIDED|95.0|-0.053|0.048||The comparison of YOCAS to the health education control is a traditional null hypothesis of no difference with a two-sided alpha. The p-value shown is from the Least Squares Mean (YOCAS - Health Education) generated from the Mixed Model.|Mixed Models Analysis||The comparison is from the Least Squares Mean difference (YOCAS - Health Education) generated from the Mixed Model.|||0.048|-0.053|0.92
72436038|NCT02613364|144384765|EQUIVALENCE|The null hypothesis is that the mean change in the outcome measure between the two arms is zero.|Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.026||0.07|TWO_SIDED|95.0|-0.004|0.098||The comparison of YOCAS to CBT-I is a traditional null hypothesis of no difference with a two-sided alpha. The p-value shown is from the Least Squares Mean (YOCAS - Health Education) generated from the Mixed Model.|Mixed Models Analysis||The comparison is from the Least Squares Mean difference (YOCAS - CBT-I) generated from the Mixed Model.|The comparison of YOCAS to the CBT-I control is a traditional null hypothesis of no difference with a two-sided alpha.||0.098|-0.004|0.07
72436039|NCT02613364|144384766|EQUIVALENCE|The null hypothesis is that the mean change in the outcome measure between the two arms is zero.|Mean Difference (Final Values)|2.27|STANDARD_ERROR_OF_MEAN|1.11||0.04|TWO_SIDED|95.0|0.09|4.44||The comparison of YOCAS to the health education control is a traditional null hypothesis of no difference with a two-sided alpha. The p-value shown is from the Least Squares Mean (YOCAS - Health Education) generated from the Mixed Model.|Mixed Models Analysis||The comparison is from the Least Squares Mean difference (YOCAS - Health Education) generated from the Mixed Model.|The comparison of YOCAS to the health education control is a traditional null hypothesis of no difference with a two-sided alpha.||4.44|0.09|0.04
72436040|NCT02613364|144384767|EQUIVALENCE|The null hypothesis is that the mean change in the outcome measure between the two arms is zero.|Mean Difference (Final Values)|-0.77|STANDARD_ERROR_OF_MEAN|1.12||0.49|TWO_SIDED|95.0|-2.97|1.43||The comparison of YOCAS to CBT-I is a traditional null hypothesis of no difference with a two-sided alpha. The p-value shown is from the Least Squares Mean (YOCAS - Health Education) generated from the Mixed Model.|Mixed Models Analysis||The comparison is from the Least Squares Mean difference (YOCAS - CBT-I) generated from the Mixed Model.|The comparison of YOCAS to CBT-I is a traditional null hypothesis of no difference with a two-sided alpha.||1.43|-2.97|0.49
72494417|NCT04183335|144517904|SUPERIORITY||Least square mean difference|-6.19|||<|0.0001|TWO_SIDED|95.0|-8.34|-4.05||Threshold of significance at 0.05.|ANCOVA||Dupilumab 300 mg Q2W versus Placebo|A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measures are reported and continued when previous outcome measure was statistically significant at two-sided 0.05.||-4.05|-8.34|<0.0001
72494418|NCT04183335|144517905|SUPERIORITY||Least square mean difference|-2.17|||<|0.0001|TWO_SIDED|95.0|-3.07|-1.28||Threshold of significance at 0.05.|ANCOVA||Dupilumab 300 mg Q2W versus Placebo|A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measures are reported and continued when previous outcome measure was statistically significant at two-sided 0.05.||-1.28|-3.07|<0.0001
72494419|NCT04183335|144517906|SUPERIORITY||Least square mean difference|-2.6||||0.0082|TWO_SIDED|95.0|-4.52|-0.67||Threshold of significance at 0.05.|ANCOVA||Dupilumab 300 mg Q2W versus Placebo|A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measures are reported and continued when previous outcome measure was statistically significant at two-sided 0.05.||-0.67|-4.52|0.0082
72558193|NCT02554877|144645922|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|-0.63|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001|TWO_SIDED|95.0|-0.8|-0.46||Two (2)-sided p-values were from analysis of covariance (ANCOVA) model with baseline value and treatment group as fixed effects.|ANCOVA|LS mean difference from placebo adjusted for baseline values was derived from the ANCOVA model.||Placebo was the reference and each of the active doses was the test for Week 4.||-0.46|-0.80|<0.0001
72436041|NCT02613364|144384768|EQUIVALENCE|The null hypothesis is that the mean change in the outcome measure between the two arms is zero.|Mean Difference (Final Values)|-0.04|STANDARD_ERROR_OF_MEAN|0.05||0.43|TWO_SIDED|95.0|-0.13|0.05||The comparison of YOCAS to the health education control is a traditional null hypothesis of no difference with a two-sided alpha. The p-value shown is from the Least Squares Mean (YOCAS - Health Education) generated from the Mixed Model.|Mixed Models Analysis||The comparison is from the Least Squares Mean difference (YOCAS - Health Education) generated from the Mixed Model.|The comparison of YOCAS to the health education control is a traditional null hypothesis of no difference with a two-sided alpha.||0.05|-0.13|0.43
72436042|NCT02613364|144384769|EQUIVALENCE|The null hypothesis is that the mean change in the outcome measure between the two arms is zero.|Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.05||0.7|TWO_SIDED|95.0|-0.07|0.11||The comparison of YOCAS to CBT-I is a traditional null hypothesis of no difference with a two-sided alpha. The p-value shown is from the Least Squares Mean (YOCAS - Health Education) generated from the Mixed Model.|Mixed Models Analysis||The comparison is from the Least Squares Mean difference (YOCAS - CBT-I) generated from the Mixed Model.|The comparison of YOCAS to CBT-I is a traditional null hypothesis of no difference with a two-sided alpha.||0.11|-0.07|0.70
72436043|NCT02613364|144384770|EQUIVALENCE|The null hypothesis is that the mean change in the outcome measure between the two arms is zero.|Mean Difference (Final Values)|-1.57|STANDARD_ERROR_OF_MEAN|0.55||0.0041|TWO_SIDED|95.0|-2.65|-0.5||The comparison of YOCAS to the health education control is a traditional null hypothesis of no difference with a two-sided alpha. The p-value shown is from the Least Squares Mean (YOCAS - Health Education) generated from the Mixed Model.|Mixed Models Analysis||The comparison is from the Least Squares Mean difference (YOCAS - Health Education) generated from the Mixed Model.|The comparison of YOCAS to the health education control is a traditional null hypothesis of no difference with a two-sided alpha.||-0.50|-2.65|0.0041
72436044|NCT02613364|144384771|EQUIVALENCE|The null hypothesis is that the mean change in the outcome measure between the two arms is zero.|Mean Difference (Final Values)|2.71|STANDARD_ERROR_OF_MEAN|0.56|<|0.0001|TWO_SIDED|95.0|1.61|3.81||The comparison of YOCAS to CBT-I is a traditional null hypothesis of no difference with a two-sided alpha. The p-value shown is from the Least Squares Mean (YOCAS - Health Education) generated from the Mixed Model.|Mixed Models Analysis||The comparison is from the Least Squares Mean difference (YOCAS - CBT-I) generated from the Mixed Model.|The comparison of YOCAS to CBT-I is a traditional null hypothesis of no difference with a two-sided alpha.||3.81|1.61|<.0001
72436045|NCT02613364|144384772|EQUIVALENCE|The null hypothesis is that the mean change in the outcome measure between the two arms is zero.|Mean Difference (Final Values)|-1.57|STANDARD_ERROR_OF_MEAN|0.62||0.0108|TWO_SIDED|95.0|-2.78|-0.36||The comparison of YOCAS to the health education control is a traditional null hypothesis of no difference with a two-sided alpha. The p-value shown is from the Least Squares Mean (YOCAS - Health Education) generated from the Mixed Model.|Mixed Models Analysis||The comparison is from the Least Squares Mean difference (YOCAS - Health Education) generated from the Mixed Model.|The comparison of YOCAS to the health education control is a traditional null hypothesis of no difference with a two-sided alpha.||-0.36|-2.78|0.0108
72436046|NCT02613364|144384773|EQUIVALENCE|The null hypothesis is that the mean change in the outcome measure between the two arms is zero.|Mean Difference (Final Values)|2.78|STANDARD_ERROR_OF_MEAN|0.63|<|0.0001|TWO_SIDED|95.0|1.54|4.02||The comparison of YOCAS to CBT-I is a traditional null hypothesis of no difference with a two-sided alpha. The p-value shown is from the Least Squares Mean (YOCAS - CBT-I) generated from the Mixed Model.|Mixed Models Analysis||The comparison is from the Least Squares Mean difference (YOCAS - CBT-I) generated from the Mixed Model.|The comparison of YOCAS to CBT-I is a traditional null hypothesis of no difference with a two-sided alpha.||4.02|1.54|<.0001
72436047|NCT00371566|144384784|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.7|STANDARD_DEVIATION|1.93||0.394||95.0|-5.5|2.19|||ANCOVA|Null hypothesis or reject it in favor of the two sided alternative hypothesis||The study was designed to provide evidence to support the null hypothesis: Delta equals 0% or reject it in favor of the two sided alternative hypothesis: Delta does not equal 0%, where Delta was the difference in the true response rate for the two treatment groups.||2.19|-5.50|.394
72436048|NCT00972504|144384829|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|0.27|||TWO_SIDED|95.0|-1.2|-0.1||||||||-0.1|-1.2|
72436049|NCT00972504|144384829|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.3|STANDARD_ERROR_OF_MEAN|0.27|||TWO_SIDED|95.0|-1.8|-0.8||||||||-0.8|-1.8|
72558194|NCT02554877|144645922|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|-0.62|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001|TWO_SIDED|95.0|-0.79|-0.46||Two (2)-sided p-values were from analysis of covariance (ANCOVA) model with baseline value and treatment group as fixed effects.|ANCOVA|LS mean difference from placebo adjusted for baseline values was derived from the ANCOVA model.||Placebo was the reference and each of the active doses was the test for Week 4.||-0.46|-0.79|<0.0001
72558195|NCT02554877|144645922|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|-0.71|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001|TWO_SIDED|95.0|-0.93|-0.49||Two (2)-sided p-values were from analysis of covariance (ANCOVA) model with baseline value and treatment group as fixed effects.|ANCOVA|LS mean difference from placebo adjusted for baseline values was derived from the ANCOVA model||Placebo was the reference and each of the active doses was the test for Week 8.||-0.49|-0.93|<0.0001
72618748|NCT01026038|144768109|SUPERIORITY_OR_OTHER||GMT ratio|1.0|||||TWO_SIDED|95.0|0.71|1.4||||||Serotype 6A: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||1.40|0.71|
72436050|NCT00972504|144384829|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.4|STANDARD_ERROR_OF_MEAN|0.27|||TWO_SIDED|95.0|-1.9|-0.8||||||||-0.8|-1.9|
72618749|NCT01026038|144768109|SUPERIORITY_OR_OTHER||GMT ratio|0.9|||||TWO_SIDED|95.0|0.66|1.31||||||Serotype 6A: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.31|0.66|
72558196|NCT02554877|144645922|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|-0.96|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001|TWO_SIDED|95.0|-1.17|-0.74||Two (2)-sided p-values were from analysis of covariance (ANCOVA) model with baseline value and treatment group as fixed effects..|ANCOVA|LS mean difference from placebo adjusted for baseline values was derived from the ANCOVA model.||Placebo was the reference and each of the active doses was the test for Week 8.||-0.74|-1.17|<0.0001
72383878|NCT01675427|144275956|SUPERIORITY_OR_OTHER|||||||0.0463|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G3||||0.0463
72383879|NCT01675427|144275956|SUPERIORITY_OR_OTHER|||||||0.9393|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G4||||0.9393
72383880|NCT01675427|144275956|SUPERIORITY_OR_OTHER|||||||0.3404|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Other genotypes||||0.3404
72383881|NCT01675427|144275956|SUPERIORITY_OR_OTHER|||||||0.4237|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Total genotypes||||0.4237
72383882|NCT01675427|144275957|SUPERIORITY_OR_OTHER|||||||0.251|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G1||||0.2510
72383883|NCT01675427|144275957|SUPERIORITY_OR_OTHER|||||||0.2943|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G2||||0.2943
72436051|NCT00972504|144384830|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.09|||TWO_SIDED|95.0|0.0|0.3|||||Comparison of Nasal Blockage between Placebo and GSK1004723 1000 µg once daily.|||0.3|-0.0|
72436052|NCT00972504|144384830|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.09|||TWO_SIDED|95.0|-0.4|-0.1|||||Comparison of Nasal Blockage between Placebo and GSK835726 10 mg once daily.|||-0.1|-0.4|
72436053|NCT00972504|144384830|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.09|||TWO_SIDED|95.0|-0.4|-0.1|||||Comparison of Nasal Blockage between Placebo and Cetirizine 10 mg once daily.|||-0.1|-0.4|
72436054|NCT00972504|144384830|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.08|||TWO_SIDED|95.0|-0.4|-0.1|||||Comparison of Rhinorrhoea between Placebo and GSK1004723 1000 µg once daily.|||-0.1|-0.4|
72436055|NCT00972504|144384830|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.08|||TWO_SIDED|95.0|-0.6|-0.2|||||Comparison of Rhinorrhoea between Placebo and GSK835726 10 mg once daily.|||-0.2|-0.6|
72436056|NCT00972504|144384830|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|0.08|||TWO_SIDED|95.0|-0.6|-0.3|||||Comparison of Rhinorrhoea between Placebo and Cetirizine 10 mg once daily.|||-0.3|-0.6|
72436057|NCT00972504|144384830|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.08|||TWO_SIDED|95.0|-0.4|-0.1|||||Comparison of Nasal Itching between Placebo and GSK1004723 1000 µg once daily.|||-0.1|-0.4|
72436058|NCT00972504|144384830|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.08|||TWO_SIDED|95.0|-0.5|-0.2|||||Comparison of Nasal Itching between Placebo and GSK835726 10 mg once daily.|||-0.2|-0.5|
72436059|NCT00972504|144384830|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.08|||TWO_SIDED|95.0|-0.5|-0.2|||||Comparison of Nasal Itching between Placebo and Cetirizine 10 mg once daily.|||-0.2|-0.5|
72436060|NCT00972504|144384830|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.07|||TWO_SIDED|95.0|-0.5|-0.2|||||Comparison of Sneezing between Placebo and GSK1004723 1000 µg once daily.|||-0.2|-0.5|
72436061|NCT00972504|144384830|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.07|||TWO_SIDED|95.0|-0.4|-0.2|||||Comparison of Sneezing between Placebo and GSK835726 10mg once daily.|||-0.2|-0.4|
72436062|NCT00972504|144384830|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.07|||TWO_SIDED|95.0|-0.5|-0.2|||||Comparison of Sneezing between Placebo and Cetirizine 10mg once daily.|||-0.2|-0.5|
72436063|NCT00972504|144384831|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.041|STANDARD_ERROR_OF_MEAN|0.4194|||TWO_SIDED|95.0|-1.87|-0.212||||||||-0.212|-1.870|
72436064|NCT00972504|144384831|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.76|STANDARD_ERROR_OF_MEAN|0.4172|||TWO_SIDED|95.0|-2.584|-0.936||||||||-0.936|-2.584|
72436065|NCT00972504|144384831|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.792|STANDARD_ERROR_OF_MEAN|0.4224|||TWO_SIDED|95.0|-3.626|-1.957||||||||-1.957|-3.626|
72436066|NCT00972504|144384832|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.32|STANDARD_ERROR_OF_MEAN|0.306|||TWO_SIDED|95.0|-0.28|0.93||||||||0.93|-0.28|
72383884|NCT01675427|144275957|SUPERIORITY_OR_OTHER|||||||0.0478|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G3||||0.0478
72383885|NCT01675427|144275957|SUPERIORITY_OR_OTHER|||||||0.5387|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G4||||0.5387
72383886|NCT01675427|144275957|SUPERIORITY_OR_OTHER|||||||0.3878|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Other genotypes||||0.3878
72383887|NCT01675427|144275957|SUPERIORITY_OR_OTHER|||||||0.0748|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Total genotypes||||0.0748
72383888|NCT01675427|144275958|SUPERIORITY_OR_OTHER|||||||0.9887|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G1||||0.9887
72383889|NCT01675427|144275958|SUPERIORITY_OR_OTHER|||||||0.5507|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G2||||0.5507
72383890|NCT01675427|144275958|SUPERIORITY_OR_OTHER|||||||0.0175|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G3||||0.0175
72383891|NCT01675427|144275958|SUPERIORITY_OR_OTHER|||||||0.2246|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G4||||0.2246
72558197|NCT02554877|144645922|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|-0.98|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001|TWO_SIDED|95.0|-1.2|-0.76||Two (2)-sided p-values were from analysis of covariance (ANCOVA) model with baseline value and treatment group as fixed effects.|ANCOVA|LS mean difference from placebo adjusted for baseline values was derived from the ANCOVA model.||Placebo was the reference and each of the active doses was the test for Week 8.||-0.76|-1.20|<0.0001
72558198|NCT02554877|144645923|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|-37.83|STANDARD_ERROR_OF_MEAN|5.13|<|0.0001|TWO_SIDED|95.0|-47.96|-27.7||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 2.||-27.70|-47.96|<0.0001
72558199|NCT02554877|144645923|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|-44.85|STANDARD_ERROR_OF_MEAN|5.13|<|0.0001|TWO_SIDED|95.0|-54.98|-34.72||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 2.||-34.72|-54.98|<0.0001
72558200|NCT02554877|144645923|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|-48.59|STANDARD_ERROR_OF_MEAN|5.18|<|0.0001|TWO_SIDED|95.0|-58.81|-38.37||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 2.||-38.37|-58.81|<0.0001
72558201|NCT02554877|144645923|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|-30.63|STANDARD_ERROR_OF_MEAN|6.03|<|0.0001|TWO_SIDED|95.0|-42.52|-18.74||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 4.||-18.74|-42.52|<0.0001
72558202|NCT02554877|144645923|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|-39.24|STANDARD_ERROR_OF_MEAN|6.03|<|0.0001|TWO_SIDED|95.0|-51.13|-27.35||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 4.||-27.35|-51.13|<0.0001
72558203|NCT02554877|144645923|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|-38.3|STANDARD_ERROR_OF_MEAN|6.04|<|0.0001|TWO_SIDED|95.0|-50.22|-26.38||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 4.||-26.38|-50.22|<0.0001
72558204|NCT02554877|144645923|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|-19.47|STANDARD_ERROR_OF_MEAN|6.29||0.0023|TWO_SIDED|95.0|-31.88|-7.05||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 8.||-7.05|-31.88|0.0023
72558205|NCT02554877|144645923|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|-36.98|STANDARD_ERROR_OF_MEAN|6.23|<|0.0001|TWO_SIDED|95.0|-49.27|-24.69||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 8.||-24.69|-49.27|<0.0001
72558206|NCT02554877|144645923|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|-35.14|STANDARD_ERROR_OF_MEAN|6.29|<|0.0001|TWO_SIDED|95.0|-47.55|-22.72||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 8.||-22.72|-47.55|<0.0001
72558207|NCT02554877|144645923|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|-19.77|STANDARD_ERROR_OF_MEAN|6.1||0.0014|TWO_SIDED|95.0|-31.81|-7.73||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 12.||-7.73|-31.81|0.0014
72558208|NCT02554877|144645923|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|-35.26|STANDARD_ERROR_OF_MEAN|6.03|<|0.0001|TWO_SIDED|95.0|-47.17|-23.35||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 12||-23.35|-47.17|<0.0001
72558209|NCT02554877|144645923|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|-36.44|STANDARD_ERROR_OF_MEAN|6.07|<|0.0001|TWO_SIDED|95.0|-48.43|-24.46||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 12||-24.46|-48.43|<0.0001
72436067|NCT00972504|144384832|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.05|STANDARD_ERROR_OF_MEAN|0.305|||TWO_SIDED|95.0|-1.65|-0.45||||||||-0.45|-1.65|
72436068|NCT00972504|144384832|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.07|STANDARD_ERROR_OF_MEAN|0.308||||95.0|-1.68|-0.46||||||||-0.46|-1.68|
72436069|NCT00768651|144384854|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0|||||t-test, 2 sided|||The sample size of 8 was determined to provide a 95% confidence interval expected width of 0.62 for the proportion of subjects who become insulin independent with treatment. Four of eight subjects (50%) would have to achieve insulin independence in order to reject the null hypothesis with 85% power and one sided alpha of 0.025. Statistical significance was set at 5%. Mean values were computed using Student's t-test while medians were compared using Wilcoxon's test.||||< 0.05
72558210|NCT02554877|144645924|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.057||||0.0059|TWO_SIDED|95.0|1.68|21.82||P-value was derived from the logistic regression model with treatment (categorical) and baseline HbA1c as covariate.|Regression, Logistic|||Placebo was the reference and each of the active doses was the test for Week 12 (HbA1C\<7%)||21.82|1.68|0.0059
72383892|NCT01675427|144275958|SUPERIORITY_OR_OTHER|||||||0.3519|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Other genotypes||||0.3519
72436070|NCT01264718|144384892|OTHER|The Intervention Cost-Effectiveness Ratio (ICER) is the difference in total costs between the intervention group and controls was divided by the intergroup difference in the proportion of insured children.|ICER|6.0|||||TWO_SIDED||||||||The estimated value is the savings per child per year insured.|||||
72436071|NCT01264718|144384892|OTHER|The Intervention Cost-Effectiveness Ratio (ICER) is the difference in total costs between the intervention group and controls was divided by the intergroup difference in the proportion of insured children.|ICER|4.0|||||TWO_SIDED||||||||The estimated value is the savings for each percent increase in children obtaining insurance per year.|||||
72436072|NCT01144182|144384896|SUPERIORITY_OR_OTHER|||||||0.56|TWO_SIDED|||||For this pilot study, significance level was set at p\<0.05|Wilcoxon (Mann-Whitney)|||||||.56
72436073|NCT01144182|144384897|SUPERIORITY_OR_OTHER|||||||0.22|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.22
72436074|NCT01144182|144384898|SUPERIORITY_OR_OTHER|||||||0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.05
72436075|NCT01144182|144384899|SUPERIORITY_OR_OTHER|||||||0.34|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.34
72436076|NCT01144182|144384900|SUPERIORITY_OR_OTHER|||||||0.008|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.008
72494420|NCT04183335|144517914|SUPERIORITY||LS mean difference|-0.7||||0.0119|TWO_SIDED|95.0|-1.25|-0.15||Threshold of significance at \<0.05 level.|ANCOVA||Dupilumab 300 mg Q2W versus Placebo|||-0.15|-1.25|0.0119
72494421|NCT03193398|144517976|OTHER||Mean Difference (Net)|-1.3||||0.5939|TWO_SIDED|95.0|-6.3|3.6|||MMRM|MMRM: mixed model for repeated measures||Difference in LS Means (BTRX-246040 - Placebo)||3.6|-6.3|0.5939
72383893|NCT01675427|144275958|SUPERIORITY_OR_OTHER|||||||0.714|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Total genotypes||||0.7140
72383894|NCT01675427|144275959|SUPERIORITY_OR_OTHER|||||||0.8622|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G1||||0.8622
72383895|NCT01675427|144275959|SUPERIORITY_OR_OTHER|||||||0.1622|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G2||||0.1622
72436077|NCT01144182|144384901|SUPERIORITY_OR_OTHER|||||||0.3|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.30
72436078|NCT01144182|144384902|SUPERIORITY_OR_OTHER|||||||0.15|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.15
72436079|NCT01144182|144384903|SUPERIORITY_OR_OTHER|||||||0.55|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.55
72436080|NCT01144182|144384904|SUPERIORITY_OR_OTHER|||||||0.56|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.56
72436081|NCT01144182|144384905|SUPERIORITY_OR_OTHER|||||||0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.05
72436082|NCT01144182|144384906|SUPERIORITY_OR_OTHER|||||||0.15|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.15
72436083|NCT01144182|144384907|SUPERIORITY_OR_OTHER|||||||0.26|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.26
72436084|NCT01144182|144384908|SUPERIORITY_OR_OTHER|||||||0.36|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.36
72436085|NCT03772964|144384910|SUPERIORITY|Comparisons between samples and sample groups (beta-diversity), were evaluated with ADONIS (aka PERMANOVA) comparisons of differences between sample groups.|R2|0.071435|||<|0.01|TWO_SIDED||||||ADONISBeta Diversity|Comparisons between samples and sample groups (beta-diversity) were evaluated with ADONIS (aka PERMANOVA)|R2 values estimate the amount of variation explained by each variable.|Beta Diversity - Differences between Samples and Sample groups||||<0.01
72436086|NCT03772964|144384911|SUPERIORITY|||||||0.6057|||||||ANOVA|||||||0.6057
72436087|NCT03772964|144384913|SUPERIORITY||||||<|0.001|||||||ANOVA|||||||<0.001
72436088|NCT03772964|144384914|SUPERIORITY|||||||0.69|||||||ANOVA|||||||0.69
72436089|NCT03538054|144384918|SUPERIORITY||Slope|-5.065||||0.146|TWO_SIDED|||||The clinical threshold was p \< 0.05, with no corrections for multiple comparisons.|GEE|Outcome scores were mean-centered by participant, allowing analyses to reflect within-person changes rather than between-person differences.||||||0.146
72436090|NCT03538054|144384919|SUPERIORITY||Slope|4.221||||0.052|TWO_SIDED|||||The clinical threshold was p \< 0.05, with no corrections for multiple comparisons.|GEE|Outcome scores were mean-centered by participant, allowing analyses to reflect within-person changes rather than between-person differences.||||||0.052
72618750|NCT01026038|144768109|SUPERIORITY_OR_OTHER||GMT ratio|0.9|||||TWO_SIDED|95.0|0.63|1.39||||||Serotype 6A: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.39|0.63|
72618751|NCT01026038|144768109|SUPERIORITY_OR_OTHER||GMT ratio|0.5|||||TWO_SIDED|95.0|0.41|0.7||||||Serotype 7F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||0.70|0.41|
72383896|NCT01675427|144275959|SUPERIORITY_OR_OTHER|||||||0.2566|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G3||||0.2566
72494422|NCT03193398|144517977|OTHER||Mean Difference (Net)|-1.0||||0.5503|TWO_SIDED|95.0|-4.4|2.3|||MMRM|MMRM: mixed model for repeated measures||Analysis of Change from Baseline in Investigator-administered MADRS-6 Total Score at week 8||2.3|-4.4|0.5503
72494423|NCT03193398|144517978|OTHER||Mean Difference (Net)|0.8||||0.3906|TWO_SIDED|95.0|-1.1|2.8|||MMRM|MMRM: mixed model for repeated measures||||2.8|-1.1|0.3906
72494424|NCT03193398|144517979|OTHER||Mean Difference (Net)|0.9||||0.4187|TWO_SIDED|95.0|-1.3|3.1||+/-|MMRM|MMRM: mixed model for repeated measures||||3.1|-1.3|0.4187
72494425|NCT03193398|144517980|OTHER||Mean Difference (Net)|-3.0||||0.4869|TWO_SIDED|95.0|-11.5|5.5|||MMRM|MMRM: mixed model for repeated measures||||5.5|-11.5|0.4869
72494426|NCT03193398|144517981|OTHER||Mean Difference (Net)|1.2||||0.5178|TWO_SIDED|95.0|-2.4|4.7|||MMRM|MMRM: mixed model for repeated measures||||4.7|-2.4|0.5178
72494427|NCT03806127|144517982|OTHER||Cochran-Mantel-Haenszel (CMH) Difference|-1.9|||||TWO_SIDED|90.0|-16.1|12.3|||||Difference in proportion and corresponding confidence interval were calculated using the CMH risk difference estimate stratified by randomized Baseline abdominal pain (\< 6 versus ≥ 6) strata, with weights proposed by Greenland and Robins.|||12.3|-16.1|
72436091|NCT03360396|144384925|OTHER|Study was closed early in all regions except for France. Statistical Analysis plan was updated to include descriptive statistics only. Sites in France remain open and all subjects in France will be followed through 36 months.||||||||||||Study was closed early in all regions except for France. Statistical Analysis plan was updated to include descriptive statistics only. Sites in France remain open and all subjects in France will be followed through 36 months.||Study was closed early in all regions except for France. SAP was updated to include descriptive statistics only. French sites remain open.||Study was closed early in all regions except for France. Statistical Analysis plan was updated to include descriptive statistics only. Sites in France remain open and all subjects in France will be followed through 36 months.|Study was closed early in all regions except for France. Statistical Analysis plan was updated to include descriptive statistics only. Sites in France remain open and all subjects in France will be followed through 36 months.|||
72558211|NCT02554877|144645924|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|8.927||||0.0008|TWO_SIDED|95.0|2.49|31.96||P-value was derived from the logistic regression model with treatment (categorical) and baseline HbA1c as covariate.|Regression, Logistic|||Placebo was the reference and each of the active doses was the test for Week 12 (HbA1C\<7%)||31.96|2.49|0.0008
72558212|NCT02554877|144645924|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|15.116|||<|0.0001|TWO_SIDED|95.0|4.34|52.67||P-value was derived from the logistic regression model with treatment (categorical) and baseline HbA1c as covariate.|Regression, Logistic|||Placebo was the reference and each of the active doses was the test for Week 12 (HbA1C\<7%)||52.67|4.34|<0.0001
72558213|NCT02554877|144645924|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.34||||0.1532|TWO_SIDED|95.0|0.64|17.47||P-value was derived from the logistic regression model with treatment (categorical) and baseline HbA1c as covariate.|Regression, Logistic|||Placebo was the reference and each of the active doses was the test for Week 12 (HbA1C\<6.5%)||17.47|0.64|0.1532
72558214|NCT02554877|144645924|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|4.198||||0.0826|TWO_SIDED|95.0|0.83|21.22||P-value was derived from the logistic regression model with treatment (categorical) and baseline HbA1c as covariate.|Regression, Logistic|||Placebo was the reference and each of the active doses was the test for Week 12 (HbA1C\<6.5%)||21.22|0.83|0.0826
72558215|NCT02554877|144645924|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.588||||0.0272|TWO_SIDED|95.0|1.21|25.73||P-value was derived from the logistic regression model with treatment (categorical) and baseline HbA1c as covariate.|Regression, Logistic|||Placebo was the reference and each of the active doses was the test for Week 12 (HbA1C\<6.5%)||25.73|1.21|0.0272
72436092|NCT03360396|144384926|OTHER|Study was terminated early, and Statistical Analysis plan was updated to include descriptive statistics only.||||||||||||Study was terminated early, and Statistical Analysis plan was updated to include descriptive statistics only.||Study was terminated early, and Statistical Analysis plan was updated to include descriptive statistics only.||Study was terminated early, and Statistical Analysis plan was updated to include descriptive statistics only.|Study was terminated early, and Statistical Analysis plan was updated to include descriptive statistics only.|||
72436093|NCT03254394|144384929|SUPERIORITY||Mean Difference (Final Values)|6.88||||0.318|TWO_SIDED|95.0|-7.09|20.85||p-value was not adjusted for any parameter.|t-test, 2 sided|||Null hypothesis: Average AUC of cold pain score over 14 days of a chemotherapy cycle in the Control group is equal or lower than that of the experimental group. The comparison is for average AUC values over 7 cycles of chemotherapy per patient||20.85|-7.09|0.318
72436094|NCT03254394|144384929|SUPERIORITY||Mean Difference (Final Values)|7.67||||0.466|TWO_SIDED|95.0|-13.76|29.1||p-value was not adjusted for any parameter.|t-test, 2 sided|||Null hypothesis: Cold hypersensitivity counted as unpleasantness score for 14 days after cycle (AUC) in the Control group is less than that of the experimental group. The difference was calculated for the Cycle 6 visit.||29.10|-13.76|0.466
72494428|NCT03806127|144517983|OTHER||CMH Difference|9.1|||||TWO_SIDED|90.0|-4.8|22.9|||||Difference in proportion and corresponding confidence interval were calculated using the CMH risk difference estimate stratified by randomized Baseline abdominal pain (\< 6 versus \>= 6) strata, with weights proposed by Greenland and Robins.|IBS-D Participants||22.9|-4.8|
72494429|NCT03806127|144517983|OTHER||CMH Difference|-0.1|||||TWO_SIDED|90.0|-16.7|16.4|||||Difference in proportion and corresponding confidence interval were calculated using the CMH risk difference estimate stratified by randomized Baseline abdominal pain (\< 6 versus \>= 6) strata, with weights proposed by Greenland and Robins.|IBS-M Participants||16.4|-16.7|
72436095|NCT03254394|144384930|SUPERIORITY||Median Difference (Final Values)|20.0||||0.338|TWO_SIDED|||||p-value was not adjusted for any parameter.|Wilcoxon (Mann-Whitney)|||the null hypothesis is EORTC QLQ-CIPN20 sensory score change in the Control group is equal to or less than that of the experimental group for the last follow-up study visit.||||0.338
72436096|NCT03254394|144384930|SUPERIORITY||Median Difference (Final Values)|2.0||||0.759|TWO_SIDED|||||p-value was not adjusted for any parameter.|Wilcoxon (Mann-Whitney)|||The null hypothesis is EORTC QLQ-CIPN20 sensory score change in the Control group is equal to or less than that of the experimental group for the cycle 6 (12 weeks) follow-up study visit.||||0.759
72436097|NCT03254394|144384931|SUPERIORITY||Median Difference (Final Values)|0.0||||0.581|TWO_SIDED|||||p-value was not adjusted for any parameter.|Wilcoxon (Mann-Whitney)|||The null hypothesis is NPSI total score in the Control group is equal to or less than that of the experimental group for the C3 (6 weeks) study visit.||||0.581
72558216|NCT02554877|144645929|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|-1.03|STANDARD_ERROR_OF_MEAN|3.4||0.7618|TWO_SIDED|90.0|-6.66|4.59||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 2.||4.59|-6.66|0.7618
72558217|NCT02554877|144645929|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|-0.65|STANDARD_ERROR_OF_MEAN|3.39||0.8489|TWO_SIDED|90.0|-6.25|4.96||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 2.||4.96|-6.25|0.8489
72558218|NCT02554877|144645929|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|2.47|STANDARD_ERROR_OF_MEAN|3.42||0.4699|TWO_SIDED|90.0|-3.17|8.12||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 2.||8.12|-3.17|0.4699
72436098|NCT03254394|144384931|SUPERIORITY||Median Difference (Final Values)|0.0||||0.962|TWO_SIDED|||||p-value was not adjusted for any parameter.|Wilcoxon (Mann-Whitney)|||The null hypothesis is NPSI total score in the Control group is equal to or less than that of the experimental group for the C6 (12 weeks) study visit.||||0.962
72436099|NCT03254394|144384931|SUPERIORITY||Median Difference (Final Values)|10.5||||0.365|TWO_SIDED|||||p-value was not adjusted for any parameter.|Wilcoxon (Mann-Whitney)|||The null hypothesis is NPSI total score in the Control group is equal to or less than that of the experimental group for the last follow-up study visit.||||0.365
72383897|NCT01675427|144275959|SUPERIORITY_OR_OTHER|||||||0.1574|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G4||||0.1574
72383898|NCT01675427|144275959|SUPERIORITY_OR_OTHER|||||||0.5784|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Other genotypes||||0.5784
72383899|NCT01675427|144275959|SUPERIORITY_OR_OTHER|||||||0.6603|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Total genotypes||||0.6603
72383900|NCT01675427|144275960|SUPERIORITY_OR_OTHER|||||||0.0605|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G1||||0.0605
72383901|NCT01675427|144275960|SUPERIORITY_OR_OTHER|||||||0.0899|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G2||||0.0899
72383902|NCT01675427|144275960|SUPERIORITY_OR_OTHER|||||||0.0634|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G3||||0.0634
72383903|NCT01675427|144275960|SUPERIORITY_OR_OTHER|||||||0.6165|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G4||||0.6165
72383904|NCT01675427|144275960|SUPERIORITY_OR_OTHER|||||||0.1649|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Other genotypes||||0.1649
72383905|NCT01675427|144275960|SUPERIORITY_OR_OTHER|||||||0.9159|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Total genotypes||||0.9159
72383906|NCT01675427|144275961|SUPERIORITY_OR_OTHER|||||||0.7454|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G1||||0.7454
72383907|NCT01675427|144275961|SUPERIORITY_OR_OTHER|||||||0.0016|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G2||||0.0016
72383908|NCT01675427|144275961|SUPERIORITY_OR_OTHER|||||||0.5261|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G3||||0.5261
72383909|NCT01675427|144275961|SUPERIORITY_OR_OTHER|||||||0.3422|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G4||||0.3422
72383910|NCT01675427|144275961|SUPERIORITY_OR_OTHER|||||||0.9026|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Total genotypes||||0.9026
72383911|NCT01675427|144275962|SUPERIORITY_OR_OTHER|||||||0.0017|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G1||||0.0017
72436100|NCT03254394|144384932|SUPERIORITY||Mean Difference (Final Values)|57.68||||0.73|TWO_SIDED|95.0|-1771.0|1886.0|||t-test, 2 sided|||The null hypothesis is Oxaliplatin cumulative dose in the Control group is equal to or higher than that of the experimental group.||1886|-1771|0.730
72383912|NCT01675427|144275962|SUPERIORITY_OR_OTHER|||||||0.8864|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G2||||0.8864
72383913|NCT01675427|144275962|SUPERIORITY_OR_OTHER|||||||0.0291|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G3||||0.0291
72383914|NCT01675427|144275962|SUPERIORITY_OR_OTHER|||||||0.5472|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G4||||0.5472
72383915|NCT01675427|144275962|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Other genotypes||||1.000
72383916|NCT01675427|144275962|SUPERIORITY_OR_OTHER|||||||0.1148|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Total genotypes||||0.1148
72383917|NCT01675427|144275963|SUPERIORITY_OR_OTHER|||||||0.4207|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G1||||0.4207
72383918|NCT01675427|144275963|SUPERIORITY_OR_OTHER|||||||0.0566|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G2||||0.0566
72383919|NCT01675427|144275963|SUPERIORITY_OR_OTHER|||||||0.1211|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G3||||0.1211
72383920|NCT01675427|144275963|SUPERIORITY_OR_OTHER|||||||0.3772|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G4||||0.3772
72383921|NCT01675427|144275963|SUPERIORITY_OR_OTHER|||||||0.4023|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Total genotypes||||0.4023
72383922|NCT01675427|144275964|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G1||||< 0.0001
72436101|NCT01123083|144385033|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.09||||0.051|TWO_SIDED|95.0|-0.17|0.0|||Repeated Measures Mixed Effects Model||Estimated treatment group difference, adjusted for age, region and Baseline C-peptide AUC. Confidence Interval, not adjusted for multiple comparisons.|||0.00|-0.17|0.051
72383923|NCT01675427|144275964|SUPERIORITY_OR_OTHER|||||||0.2132|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G2||||0.2132
72383924|NCT01675427|144275964|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G3||||< 0.0001
72383925|NCT01675427|144275964|SUPERIORITY_OR_OTHER|||||||0.3031|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G4||||0.3031
72383926|NCT01675427|144275964|SUPERIORITY_OR_OTHER|||||||0.955|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Other genotypes||||0.9550
72383927|NCT01675427|144275964|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Total genotypes||||< 0.0001
72383928|NCT01675427|144275965|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G1||||< 0.0001
72383929|NCT01675427|144275965|SUPERIORITY_OR_OTHER|||||||0.189|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G2||||0.1890
72383930|NCT01675427|144275965|SUPERIORITY_OR_OTHER|||||||0.5793|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G3||||0.5793
72436102|NCT01123083|144385034|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1||||0.022|TWO_SIDED|95.0|-0.18|-0.02|||Repeated Measures Mixed Effects Model||Estimated treatment group difference, adjusted for age, region and Baseline C-peptide AUC. Confidence Interval, not adjusted for multiple comparisons.|Week 12||-0.02|-0.18|0.022
72436103|NCT01123083|144385034|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.06||||0.191|TWO_SIDED|95.0|-0.15|0.03|||Repeated Measures Mixed Effects Model||Estimated treatment group difference, adjusted for age, region and Baseline C-peptide AUC. Confidence Interval, not adjusted for multiple comparisons.|Month 6||0.03|-0.15|0.191
72383931|NCT01675427|144275965|SUPERIORITY_OR_OTHER|||||||0.0847|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G4||||0.0847
72383932|NCT01675427|144275965|SUPERIORITY_OR_OTHER|||||||0.5506|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Other genotypes||||0.5506
72383933|NCT01675427|144275965|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Total genotypes||||0.0020
72383934|NCT01675427|144275966|SUPERIORITY_OR_OTHER|||||||0.0007|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G1||||0.0007
72383935|NCT01675427|144275966|SUPERIORITY_OR_OTHER|||||||0.0061|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G2||||0.0061
72383936|NCT01675427|144275966|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G3||||< 0.0001
72383937|NCT01675427|144275966|SUPERIORITY_OR_OTHER|||||||0.3885|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G4||||0.3885
72383938|NCT01675427|144275966|SUPERIORITY_OR_OTHER|||||||0.3597|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Other genotypes||||0.3597
72436104|NCT01123083|144385036|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.29||||0.912|TWO_SIDED|95.0|0.5|3.37|||GEE Model||Estimated treatment group difference, adjusted for age, region and Baseline HbA1c/Insulin Use Response. Confidence Interval, not adjusted for multiple comparisons.|Week 12||3.37|0.50|0.912
72436105|NCT01123083|144385036|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.95||||0.912|TWO_SIDED|95.0|0.37|2.42|||GEE Model||Estimated treatment group difference, adjusted for age, region and Baseline HbA1c/Insulin Use Response. Confidence Interval, not adjusted for multiple comparisons.|Month 6||2.42|0.37|0.912
72558219|NCT02554877|144645929|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|-2.22|STANDARD_ERROR_OF_MEAN|3.27||0.4979|TWO_SIDED|90.0|-7.63|3.19||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 4.||3.19|-7.63|0.4979
72383939|NCT01675427|144275966|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Total genotypes||||< 0.0001
72383940|NCT01675427|144275967|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G1||||< 0.0001
72383941|NCT01675427|144275967|SUPERIORITY_OR_OTHER|||||||0.0005|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G2||||0.0005
72383942|NCT01675427|144275967|SUPERIORITY_OR_OTHER|||||||0.011|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G3||||0.0110
72383943|NCT01675427|144275967|SUPERIORITY_OR_OTHER|||||||0.098|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G4||||0.0980
72383944|NCT01675427|144275967|SUPERIORITY_OR_OTHER|||||||0.2264|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Other genotypes||||0.2264
72383945|NCT01675427|144275967|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Total genotypes||||< 0.0001
72383946|NCT01675427|144275968|SUPERIORITY_OR_OTHER|||||||0.0098|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G1||||0.0098
72383947|NCT01675427|144275968|SUPERIORITY_OR_OTHER|||||||0.6291|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G2||||0.6291
72436106|NCT01123083|144385036|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.56||||0.412|TWO_SIDED|95.0|0.54|4.52|||GEE Model||Estimated treatment group difference, adjusted for age, region and Baseline HbA1c/Insulin Use Response. Confidence Interval, not adjusted for multiple comparisons.|Month 12||4.52|0.54|0.412
72383948|NCT01675427|144275968|SUPERIORITY_OR_OTHER|||||||0.0013|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G3||||0.0013
72383949|NCT01675427|144275968|SUPERIORITY_OR_OTHER|||||||0.5588|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G4||||0.5588
72383950|NCT01675427|144275968|SUPERIORITY_OR_OTHER|||||||0.9932|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Other genotypes||||0.9932
72383951|NCT01675427|144275968|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Total genotypes||||< 0.0001
72383952|NCT01675427|144275969|SUPERIORITY_OR_OTHER|||||||0.0007|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G1||||0.0007
72383953|NCT01675427|144275969|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G2||||0.0020
72383954|NCT01675427|144275969|SUPERIORITY_OR_OTHER|||||||0.0013|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G3||||0.0013
72383955|NCT01675427|144275969|SUPERIORITY_OR_OTHER|||||||0.7166|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G4||||0.7166
72383956|NCT01675427|144275969|SUPERIORITY_OR_OTHER|||||||0.3217|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Other genotypes||||0.3217
72383957|NCT01675427|144275969|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Total genotypes||||< 0.0001
72383958|NCT01675427|144275970|SUPERIORITY_OR_OTHER|||||||0.1894|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G1||||0.1894
72383959|NCT01675427|144275970|SUPERIORITY_OR_OTHER|||||||0.0054|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G2||||0.0054
72383960|NCT01675427|144275970|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G3||||< 0.0001
72383961|NCT01675427|144275970|SUPERIORITY_OR_OTHER|||||||0.536|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G4||||0.5360
72383962|NCT01675427|144275970|SUPERIORITY_OR_OTHER|||||||0.2185|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Other genotypes||||0.2185
72383963|NCT01675427|144275970|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Total genotypes||||< 0.0001
72383964|NCT01675427|144275971|SUPERIORITY_OR_OTHER|||||||0.0002|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G1||||0.0002
72383965|NCT01675427|144275971|SUPERIORITY_OR_OTHER|||||||0.0003|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G2||||0.0003
72383966|NCT01675427|144275971|SUPERIORITY_OR_OTHER|||||||0.0106|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G3||||0.0106
72383967|NCT01675427|144275971|SUPERIORITY_OR_OTHER|||||||0.7821|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G4||||0.7821
72383968|NCT01675427|144275971|SUPERIORITY_OR_OTHER|||||||0.2372|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Other genotypes||||0.2372
72383969|NCT01675427|144275971|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Total genotypes||||< 0.0001
72383970|NCT01675427|144275972|SUPERIORITY_OR_OTHER|||||||0.0688|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G1||||0.0688
72383971|NCT01675427|144275972|SUPERIORITY_OR_OTHER|||||||0.4367|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G2||||0.4367
72383972|NCT01675427|144275972|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G3||||< 0.0001
72383973|NCT01675427|144275972|SUPERIORITY_OR_OTHER|||||||0.1951|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G4||||0.1951
72383974|NCT01675427|144275972|SUPERIORITY_OR_OTHER|||||||0.2927|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Other genotypes||||0.2927
72383975|NCT01675427|144275972|SUPERIORITY_OR_OTHER|||||||0.0013|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Total genotypes||||0.0013
72383976|NCT01675427|144275973|SUPERIORITY_OR_OTHER|||||||0.0247|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G1||||0.0247
72383977|NCT01675427|144275973|SUPERIORITY_OR_OTHER|||||||0.0034|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G2||||0.0034
72558220|NCT02554877|144645929|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|-3.45|STANDARD_ERROR_OF_MEAN|3.27||0.2927|TWO_SIDED|90.0|-8.85|1.95||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 4.||1.95|-8.85|0.2927
72383978|NCT01675427|144275973|SUPERIORITY_OR_OTHER|||||||0.0017|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G3||||0.0017
72383979|NCT01675427|144275973|SUPERIORITY_OR_OTHER|||||||0.3346|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G4||||0.3346
72383980|NCT01675427|144275973|SUPERIORITY_OR_OTHER|||||||0.3215|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Other genotypes||||0.3215
72383981|NCT01675427|144275973|SUPERIORITY_OR_OTHER|||||||0.0003|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Total genotypes||||0.0003
72383982|NCT01675427|144275974|SUPERIORITY_OR_OTHER|||||||0.3609|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G1||||0.3609
72383983|NCT01675427|144275974|SUPERIORITY_OR_OTHER|||||||0.0018|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G2||||0.0018
72383984|NCT01675427|144275974|SUPERIORITY_OR_OTHER|||||||0.0356|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G3||||0.0356
72383985|NCT01675427|144275974|SUPERIORITY_OR_OTHER|||||||0.7044|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G4||||0.7044
72383986|NCT01675427|144275974|SUPERIORITY_OR_OTHER|||||||0.8578|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Other genotypes||||0.8578
72383987|NCT01675427|144275974|SUPERIORITY_OR_OTHER|||||||0.0076|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Total genotypes||||0.0076
72383988|NCT01675427|144275975|SUPERIORITY_OR_OTHER|||||||0.0002|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G1||||0.0002
72383989|NCT01675427|144275975|SUPERIORITY_OR_OTHER|||||||0.2017|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G2||||0.2017
72383990|NCT01675427|144275975|SUPERIORITY_OR_OTHER|||||||0.5878|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G3||||0.5878
72383991|NCT01675427|144275975|SUPERIORITY_OR_OTHER|||||||0.4144|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G4||||0.4144
72383992|NCT01675427|144275975|SUPERIORITY_OR_OTHER|||||||0.4492|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Other genotypes||||0.4492
72383993|NCT01675427|144275975|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Total genotypes||||< 0.0001
72383994|NCT01675427|144275976|SUPERIORITY_OR_OTHER|||||||0.0671|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G1||||0.0671
72383995|NCT01675427|144275976|SUPERIORITY_OR_OTHER|||||||0.1009|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G2||||0.1009
72383996|NCT01675427|144275976|SUPERIORITY_OR_OTHER|||||||0.0635|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G3||||0.0635
72383997|NCT01675427|144275976|SUPERIORITY_OR_OTHER|||||||0.4162|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G4||||0.4162
72383998|NCT01675427|144275976|SUPERIORITY_OR_OTHER|||||||0.9305|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Other genotypes||||0.9305
72383999|NCT01675427|144275976|SUPERIORITY_OR_OTHER|||||||0.0041|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Total genotypes||||0.0041
72384000|NCT01675427|144275977|SUPERIORITY_OR_OTHER|||||||0.0059|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G1||||0.0059
72384001|NCT01675427|144275977|SUPERIORITY_OR_OTHER|||||||0.2808|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G2||||0.2808
72384002|NCT01675427|144275977|SUPERIORITY_OR_OTHER|||||||0.2401|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G3||||0.2401
72384003|NCT01675427|144275977|SUPERIORITY_OR_OTHER|||||||0.2993|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G4||||0.2993
72384004|NCT01675427|144275977|SUPERIORITY_OR_OTHER|||||||0.5529|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Other genotypes||||0.5529
72436107|NCT01123083|144385037|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.03||||0.21|TWO_SIDED|95.0|-0.08|0.02|||Repeated Measures Mixed Effects Model||Estimated treatment group difference, adjusted for age, region and Baseline Mean Daily Insulin Use. Confidence Interval, not adjusted for multiple comparisons.|Week 12||0.02|-0.08|0.210
72436108|NCT01123083|144385037|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.04||||0.21|TWO_SIDED|95.0|-0.11|0.02|||Repeated Measures Mixed Effects Model||Estimated treatment group difference, adjusted for age, region and Baseline Mean Daily Insulin Use. Confidence Interval, not adjusted for multiple comparisons.|Month 6||0.02|-0.11|0.210
72436109|NCT01123083|144385037|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.04||||0.402|TWO_SIDED|95.0|-0.05|0.13|||Repeated Measures Mixed Effects Model||Estimated treatment group difference, adjusted for age, region and Baseline Mean Daily Insulin Use. Confidence Interval, not adjusted for multiple comparisons.|Month 12||0.13|-0.05|0.402
72558221|NCT02554877|144645929|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|-4.83|STANDARD_ERROR_OF_MEAN|3.28||0.143|TWO_SIDED|90.0|-10.26|0.6||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 4.||0.60|-10.26|0.1430
72558222|NCT02554877|144645929|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|-1.25|STANDARD_ERROR_OF_MEAN|3.73||0.7373|TWO_SIDED|90.0|-7.42|4.92||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 8.||4.92|-7.42|0.7373
72384005|NCT01675427|144275977|SUPERIORITY_OR_OTHER|||||||0.0005|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Total genotypes||||0.0005
72384006|NCT01675427|144275978|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||G1||||< 0.0001
72384007|NCT01675427|144275978|SUPERIORITY_OR_OTHER|||||||0.3572|TWO_SIDED|||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||G2||||0.3572
72384008|NCT01675427|144275978|SUPERIORITY_OR_OTHER|||||||0.2041|TWO_SIDED|||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||G3||||0.2041
72384009|NCT01675427|144275978|SUPERIORITY_OR_OTHER|||||||0.0467|TWO_SIDED|||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||G4||||0.0467
72384010|NCT01675427|144275978|SUPERIORITY_OR_OTHER|||||||0.0525|TWO_SIDED|||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||Other genotypes||||0.0525
72384011|NCT01675427|144275978|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||Total genotypes||||< 0.0001
72384012|NCT01675427|144275979|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||G1||||< 0.0001
72384013|NCT01675427|144275979|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||G2||||< 0.0001
72384014|NCT01675427|144275979|SUPERIORITY_OR_OTHER|||||||0.5275|TWO_SIDED|||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||G3||||0.5275
72384015|NCT01675427|144275979|SUPERIORITY_OR_OTHER|||||||0.6593|TWO_SIDED|||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||G4||||0.6593
72384016|NCT01675427|144275979|SUPERIORITY_OR_OTHER|||||||0.0372|TWO_SIDED|||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||Other genotypes||||0.0372
72384017|NCT01675427|144275979|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||Total genotypes||||< 0.0001
72384018|NCT01675427|144275980|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||G1||||< 0.0001
72384019|NCT01675427|144275980|SUPERIORITY_OR_OTHER|||||||0.3857|TWO_SIDED|||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||G2||||0.3857
72384020|NCT01675427|144275980|SUPERIORITY_OR_OTHER|||||||0.2356|TWO_SIDED|||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||G3||||0.2356
72384021|NCT01675427|144275980|SUPERIORITY_OR_OTHER|||||||0.7993|TWO_SIDED|||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||G4||||0.7993
72384022|NCT01675427|144275980|SUPERIORITY_OR_OTHER|||||||0.2164|TWO_SIDED|||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||Other genotypes||||0.2164
72384023|NCT01675427|144275980|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||Total genotypes||||< 0.0001
72384024|NCT01675427|144275981|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||G1||||< 0.0001
72384025|NCT01675427|144275981|SUPERIORITY_OR_OTHER|||||||0.0001|TWO_SIDED|||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||G2||||0.0001
72384026|NCT01675427|144275981|SUPERIORITY_OR_OTHER|||||||0.482|TWO_SIDED|||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||G3||||0.4820
72384027|NCT01675427|144275981|SUPERIORITY_OR_OTHER|||||||0.8668|TWO_SIDED|||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||G4||||0.8668
72558223|NCT02554877|144645929|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|-2.46|STANDARD_ERROR_OF_MEAN|3.7||0.5075|TWO_SIDED|90.0|-8.57|3.66||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 8.||3.66|-8.57|0.5075
72558224|NCT02554877|144645929|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|-1.81|STANDARD_ERROR_OF_MEAN|3.74||0.6295|TWO_SIDED|90.0|-7.99|4.37||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 8.||4.37|-7.99|0.6295
72558225|NCT02554877|144645929|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|3.15|STANDARD_ERROR_OF_MEAN|3.95||0.4266|TWO_SIDED|90.0|-3.39|9.69||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 12.||9.69|-3.39|0.4266
72558226|NCT02554877|144645929|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|4.96|STANDARD_ERROR_OF_MEAN|3.89||0.2038|TWO_SIDED|90.0|-1.47|11.4||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 12.||11.40|-1.47|0.2038
72558227|NCT02554877|144645929|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|2.29|STANDARD_ERROR_OF_MEAN|3.92||0.5592|TWO_SIDED|90.0|-4.19|8.78||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 12.||8.78|-4.19|0.5592
72558228|NCT02554877|144645930|SUPERIORITY_OR_OTHER||Median Difference (Net)|5.09|||||TWO_SIDED|90.0|-5.86|16.05||||||Placebo was the reference and each of the active doses was the test for Week 2.||16.05|-5.86|
72558229|NCT02554877|144645930|SUPERIORITY_OR_OTHER||Median Difference (Net)|2.86|||||TWO_SIDED|90.0|-9.76|15.48||||||Placebo was the reference and each of the active doses was the test for Week 2.||15.48|-9.76|
72384028|NCT01675427|144275981|SUPERIORITY_OR_OTHER|||||||0.2032|TWO_SIDED|||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||Other genotypes||||0.2032
72384029|NCT01675427|144275981|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||Total genotypes||||< 0.0001
72384030|NCT01675427|144275982|SUPERIORITY_OR_OTHER|||||||0.0103|TWO_SIDED|||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||G1||||0.0103
72558230|NCT02554877|144645930|SUPERIORITY_OR_OTHER||Median Difference (Net)|17.13|||||TWO_SIDED|90.0|3.91|30.34||||||Placebo was the reference and each of the active doses was the test for Week 2.||30.34|3.91|
72558231|NCT02554877|144645930|SUPERIORITY_OR_OTHER||Median Difference (Net)|2.71|||||TWO_SIDED|90.0|-10.8|16.22||||||Placebo was the reference and each of the active doses was the test for Week 4.||16.22|-10.80|
72558232|NCT02554877|144645930|SUPERIORITY_OR_OTHER||Median Difference (Net)|2.92|||||TWO_SIDED|90.0|-10.61|16.45||||||Placebo was the reference and each of the active doses was the test for Week 4.||16.45|-10.61|
72558233|NCT02554877|144645930|SUPERIORITY_OR_OTHER||Median Difference (Net)|-2.57|||||TWO_SIDED|90.0|-15.08|9.94||||||Placebo was the reference and each of the active doses was the test for Week 4.||9.94|-15.08|
72384031|NCT01675427|144275982|SUPERIORITY_OR_OTHER|||||||0.8373|TWO_SIDED|||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||G2||||0.8373
72384032|NCT01675427|144275982|SUPERIORITY_OR_OTHER|||||||0.3672|TWO_SIDED|||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||G3||||0.3672
72384033|NCT01675427|144275983|SUPERIORITY_OR_OTHER|||||||0.0637|TWO_SIDED|||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||G4||||0.0637
72558234|NCT02554877|144645930|SUPERIORITY_OR_OTHER||Median Difference (Net)|-1.63|||||TWO_SIDED|90.0|-16.29|13.03||||||Placebo was the reference and each of the active doses was the test for Week 8.||13.03|-16.29|
72558235|NCT02554877|144645930|SUPERIORITY_OR_OTHER||Median Difference (Net)|-4.59|||||TWO_SIDED|90.0|-20.4|11.22||||||Placebo was the reference and each of the active doses was the test for Week 8.||11.22|-20.40|
72558236|NCT02554877|144645930|SUPERIORITY_OR_OTHER||Median Difference (Net)|2.75|||||TWO_SIDED|90.0|-13.66|19.16||||||Placebo was the reference and each of the active doses was the test for Week 8.||19.16|-13.66|
72384034|NCT01675427|144275983|SUPERIORITY_OR_OTHER|||||||0.0474|TWO_SIDED|||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||Other genotypes||||0.0474
72384035|NCT01675427|144275983|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||Total genotypes||||< 0.0001
72384036|NCT01675427|144275984|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||G1||||< 0.0001
72384037|NCT01675427|144275984|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||G2||||< 0.0001
72384038|NCT01675427|144275984|SUPERIORITY_OR_OTHER|||||||0.5522|TWO_SIDED|||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||G3||||0.5522
72384039|NCT01675427|144275985|SUPERIORITY_OR_OTHER|||||||0.5117|TWO_SIDED|||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||G4||||0.5117
72384040|NCT01675427|144275985|SUPERIORITY_OR_OTHER|||||||0.3437|TWO_SIDED|||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||Other genotypes||||0.3437
72384041|NCT01675427|144275985|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||Total genotypes||||< 0.0001
72558237|NCT02554877|144645930|SUPERIORITY_OR_OTHER||Median Difference (Net)|7.86|||||TWO_SIDED|90.0|-3.3|19.02||||||Placebo was the reference and each of the active doses was the test for Week 12.||19.02|-3.30|
72558238|NCT02554877|144645930|SUPERIORITY_OR_OTHER||Median Difference (Net)|-1.13|||||TWO_SIDED|90.0|-16.13|13.87||||||Placebo was the reference and each of the active doses was the test for Week 12.||13.87|-16.13|
72558239|NCT02554877|144645930|SUPERIORITY_OR_OTHER||Median Difference (Net)|5.99|||||TWO_SIDED|90.0|-7.07|19.04||||||Placebo was the reference and each of the active doses was the test for Week 12.||19.04|-7.07|
72558240|NCT02554877|144645931|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|1.04|STANDARD_ERROR_OF_MEAN|2.52||0.68|TWO_SIDED|90.0|-3.12|5.2||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 2.||5.20|-3.12|0.6800
72558241|NCT02554877|144645931|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|1.64|STANDARD_ERROR_OF_MEAN|2.52||0.515|TWO_SIDED|90.0|-2.52|5.8||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 2.||5.80|-2.52|0.5150
72558242|NCT02554877|144645931|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|4.66|STANDARD_ERROR_OF_MEAN|2.53||0.0676|TWO_SIDED|90.0|0.47|8.85||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 2.||8.85|0.47|0.0676
72436110|NCT01123083|144385038|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.18||||0.582|TWO_SIDED|95.0|-0.52|0.16|||Repeated Measures Mixed Effects Model||Estimated treatment group difference, adjusted for age, region and baseline HbA1c. Confidence Interval, not adjusted for multiple comparisons.|Week 12||0.16|-0.52|0.582
72558243|NCT02554877|144645931|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|-0.62|STANDARD_ERROR_OF_MEAN|2.48||0.8021|TWO_SIDED|90.0|-4.73|3.48||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 4.||3.48|-4.73|0.8021
72558244|NCT02554877|144645931|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|-1.95|STANDARD_ERROR_OF_MEAN|2.49||0.4346|TWO_SIDED|90.0|-6.06|2.16||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 4.||2.16|-6.06|0.4346
72558245|NCT02554877|144645931|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|-2.03|STANDARD_ERROR_OF_MEAN|2.49||0.4173|TWO_SIDED|90.0|-6.15|2.09||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 4.||2.09|-6.15|0.4173
72436111|NCT01123083|144385038|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0||||0.987|TWO_SIDED|95.0|-0.46|0.45|||Repeated Measures Mixed Effects Model||Estimated treatment group difference, adjusted for age, region and baseline HbA1c. Confidence Interval, not adjusted for multiple comparisons.|Month 6||0.45|-0.46|0.987
72436112|NCT01123083|144385038|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.13||||0.572|TWO_SIDED|95.0|-0.33|0.59|||Repeated Measures Mixed Effects Model||Estimated treatment group difference, adjusted for age, region and baseline HbA1c. Confidence Interval, not adjusted for multiple comparisons.|Month 12||0.59|-0.33|0.572
72436113|NCT01123083|144385041|SUPERIORITY_OR_OTHER|||||||0.452|||||||Hochberg-adjusted p-value|||Month 6||||0.452
72436114|NCT01123083|144385041|SUPERIORITY_OR_OTHER|||||||0.452|||||||Hochberg-adjusted p-value|||Month 12||||0.452
72436115|NCT01123083|144385042|SUPERIORITY_OR_OTHER|||||||0.123|||||||Hochberg-adjusted p-value|||Month 6||||0.123
72436116|NCT01123083|144385042|SUPERIORITY_OR_OTHER|||||||0.373|||||||Hochberg-adjusted p-value|||Month 12||||0.373
72436117|NCT03418324|144385043|OTHER|Binomial proportion (Clopper-Pearson exact confidence interval) for each arm|Binomial proportion|50.0|||||TWO_SIDED|95.0|1.3|98.7|||||Estimated values reflects the percentage of participants with overall clinical benefit.|For this study, we are not comparing outcome measures between the two arms||98.7|1.3|
72436118|NCT03418324|144385043|OTHER|Binomial proportion (Clopper-Pearson exact confidence interval) for each arm|Binomial proportion|66.7|||||TWO_SIDED|95.0|22.3|95.7|||||Estimated values reflects the percentage of participants with overall clinical benefit|For this study, we are not comparing outcome measures between the two groups.||95.7|22.3|
72436119|NCT03418324|144385046|OTHER|Binomial proportion (Clopper-Pearson exact confidence interval) for each arm.|Binomial proportion|50.0|||||TWO_SIDED|95.0|1.3|98.7||||||For this study, we are not comparing outcome measures between the two arms||98.7|1.3|
72436120|NCT03418324|144385046|OTHER|Binomial proportion (Clopper-Pearson exact confidence interval) for each arm.|Binomial proportion|66.7|||||TWO_SIDED|95.0|22.3|95.7||||||For this study, we are not comparing outcome measures between the two arms.||95.7|22.3|
72436121|NCT03418324|144385047|OTHER|Binomial proportion (Clopper-Pearson exact confidence interval) for each arm.|Binomial proportion|50.0|||||TWO_SIDED|95.0|1.3|98.7||||||For this study, we are not comparing outcome measures between the two arms.||98.7|1.3|
72436122|NCT03418324|144385047|OTHER|Binomial proportion (Clopper-Pearson exact confidence interval) for each arm.|Binomial proportion|50.0|||||TWO_SIDED|95.0|11.8|88.2||||||For this study, we are not comparing outcome measures between the two arms.||88.2|11.8|
72436123|NCT01867580|144385071|SUPERIORITY|||||||0.677|||||||Regression, Logistic|||||||0.6770
72436124|NCT01867580|144385072|SUPERIORITY|||||||0.0202|||||||Wilcoxon (Mann-Whitney)|||||||0.0202
72558246|NCT02554877|144645931|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|-0.98|STANDARD_ERROR_OF_MEAN|2.56||0.7036|TWO_SIDED|90.0|-5.21|3.26||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 8.||3.26|-5.21|0.7036
72494430|NCT03806127|144517983|OTHER||CMH Difference|5.3|||||TWO_SIDED|90.0|-5.4|15.9|||||Difference in proportion and corresponding confidence interval were calculated using the CMH risk difference estimate stratified by randomized Baseline abdominal pain (\< 6 versus \>= 6) strata, with weights proposed by Greenland and Robins.|All Participants||15.9|-5.4|
72436125|NCT01867580|144385073|SUPERIORITY|||||||0.0142|||||||Regression, Logistic|||||||0.0142
72436126|NCT03224299|144385099|NON_INFERIORITY|Investigational product cannot be more than 0.05 log10 CFU/cm\^2 less than the active control|Mean Difference (Final Values)|0.12|||||TWO_SIDED|95.0|-0.44|0.69||||||"Abdomen 10 minutes~Average treatment effect, calculated using a linear regression model for each body site, was used for primary analysis. In the model, the response was the post-treatment log10 bacterial counts and predictors were the treatment effect as a fixed effect and the pre-treatment log10 bacterial counts as a covariate."||0.69|-0.44|
72436127|NCT03224299|144385099|SUPERIORITY||Mean Difference (Final Values)|1.93|||||TWO_SIDED|95.0|1.36|2.49||||||Abdomen 10 minutes Average treatment effect, calculated using a linear regression model for each body site, was used for primary analysis. In the model, the response was the post-treatment log10 bacterial counts and predictors were the treatment effect as a fixed effect and the pre-treatment log10 bacterial counts as a covariate.||2.49|1.36|
72436128|NCT03224299|144385099|NON_INFERIORITY|Investigational product cannot be more than 0.05 log10 CFU/cm\^2 less than the active control|Mean Difference (Final Values)|-0.18|||||TWO_SIDED|95.0|-0.73|0.36||||||Abdomen 10 minutes Average treatment effect, calculated using a linear regression model for each body site, was used for primary analysis. In the model, the response was the post-treatment log10 bacterial counts and predictors were the treatment effect as a fixed effect and the pre-treatment log10 bacterial counts as a covariate.||0.36|-0.73|
72436129|NCT03224299|144385099|SUPERIORITY||Mean Difference (Final Values)|2.23|||||TWO_SIDED|95.0|1.69|2.78||||||Abdomen 10 minutes Average treatment effect, calculated using a linear regression model for each body site, was used for primary analysis. In the model, the response was the post-treatment log10 bacterial counts and predictors were the treatment effect as a fixed effect and the pre-treatment log10 bacterial counts as a covariate.||2.78|1.69|
72436130|NCT03224299|144385099|NON_INFERIORITY|Investigational product cannot be more than 0.05 log10 CFU/cm\^2 less than the active control|Mean Difference (Final Values)|-0.3|||||TWO_SIDED|95.0|-0.9|0.31||||||Groin 10 minutes Average treatment effect, calculated using a linear regression model for each body site, was used for primary analysis. In the model, the response was the post-treatment log10 bacterial counts and predictors were the treatment effect as a fixed effect and the pre-treatment log10 bacterial counts as a covariate.||0.31|-0.90|
72436131|NCT03224299|144385099|SUPERIORITY||Mean Difference (Final Values)|2.6|||||TWO_SIDED|95.0|1.98|3.22||||||Groin 10 minutes Average treatment effect, calculated using a linear regression model for each body site, was used for primary analysis. In the model, the response was the post-treatment log10 bacterial counts and predictors were the treatment effect as a fixed effect and the pre-treatment log10 bacterial counts as a covariate.||3.22|1.98|
72436132|NCT03224299|144385099|NON_INFERIORITY|Investigational product cannot be more than 0.05 log10 CFU/cm\^2 less than the active control|Mean Difference (Final Values)|-0.02|||||TWO_SIDED|95.0|-0.61|0.57||||||Groin 10 minutes Average treatment effect, calculated using a linear regression model for each body site, was used for primary analysis. In the model, the response was the post-treatment log10 bacterial counts and predictors were the treatment effect as a fixed effect and the pre-treatment log10 bacterial counts as a covariate.||0.57|-0.61|
72494431|NCT03806127|144517984|OTHER||CMH Difference|1.6|||||TWO_SIDED|90.0|-11.7|14.9|||||Difference in proportion and corresponding confidence interval were calculated using the CMH risk difference estimate stratified by randomized Baseline abdominal pain (\< 6 versus \>= 6) strata, with weights proposed by Greenland and Robins.|||14.9|-11.7|
72494432|NCT03806127|144517985|OTHER||CMH Difference|6.7|||||TWO_SIDED|90.0|-5.5|18.8|||||Difference in proportion and corresponding confidence interval were calculated using the CMH risk difference estimate stratified by randomized Baseline abdominal pain (\< 6 versus ≥ 6) strata, with weights proposed by Greenland and Robins.|||18.8|-5.5|
72494433|NCT03823391|144518003|SUPERIORITY||Least Squares (LS) Mean Difference|-0.52|STANDARD_ERROR_OF_MEAN|0.215||0.022|TWO_SIDED|90.0|-0.89|-0.15|||Mixed-effect model repeated measurement|Analysis includes treatment, visit, stratification factors, and treatment-by-visit interaction as fixed factors and Baseline value as covariate.|Between groups difference was a single-arm comparison of LS mean of ABBV-3373 estimated from the MMRM model above minus the historical mean of adalimumab (-2.13).|Two primary comparisons were performed between ABBV-3373 and adalimumab. The first was the comparison of ABBV-3373 to historical adalimumab reference value -2.13 based on a meta-analysis consisting of 242 subjects from 3 historical adalimumab studies in which the success criterion was 2-sided P value ≤ 0.1.||-0.15|-0.89|0.022
72494434|NCT03823391|144518003|SUPERIORITY|||||||0.899||||||Posterior probability|Historical data borrowing|Based on posterior distribution of means for each group, the probability of Treatment mean - Control mean \< 0 given the observed data was calculated.||The second comparison was ABBV-3373 to adalimumab with combined in-trial and borrowed historical adalimumab data using a Bayesian historical borrowing approach in which the success criterion was posterior probability of ABBV-3373 being better than adalimumab \> 95%. When borrowing 30 historical adalimumab subjects, the combined least squares mean change from Baseline was -2.29.||||0.899
72494435|NCT03823391|144518003|SUPERIORITY||LS Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.353||0.683|TWO_SIDED|90.0|-0.74|0.45|||Mixed Effect Model Repeated Measurement|Analysis includes treatment, visit, stratification factors, and treatment-by-visit interaction as fixed factors and Baseline value as covariate.|Treatment difference = ABBV-3373 - Adalimumab|The mean difference in change from Baseline in DAS28 (CRP) at Week 12 between ABBV-3373 and adalimumab was also estimated only based on in-study data.||0.45|-0.74|0.683
72494436|NCT03823391|144518004|SUPERIORITY||LS Mean Difference|-1.69|STANDARD_ERROR_OF_MEAN|3.207||0.601|TWO_SIDED|90.0|-7.08|3.7|||Mixed Effect Model Repeated Measurement|Analysis includes treatment, visit, stratification factors, and treatment-by-visit interaction as fixed factors and Baseline value as covariate.|Treatment difference = ABBV-3373 - Adalimumab|||3.70|-7.08|0.601
72504613|NCT02858193|144540041|EQUIVALENCE|Acceptance criterion for bioequivalence was that 94.12% confidence intervals (CIs) of the T/R ratios of the geometric means of the analysed PK parameters were within the 80.00-125.00% range according to the current guidelines for bioequivalence studies.||||||0.593|||||||Friedman|||||||0.5930
72504614|NCT01582282|144540045|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|30.64||||0.028|||||||ANCOVA|||||||0.028
72558247|NCT02554877|144645931|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|-2.64|STANDARD_ERROR_OF_MEAN|2.54||0.2993|TWO_SIDED|90.0|-6.84|1.56||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 8.||1.56|-6.84|0.2993
72558248|NCT02554877|144645931|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|0.08|STANDARD_ERROR_OF_MEAN|2.57||0.9751|TWO_SIDED|90.0|-4.16|4.32||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 8.||4.32|-4.16|0.9751
72558249|NCT02554877|144645931|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|4.23|STANDARD_ERROR_OF_MEAN|2.86||0.1408|TWO_SIDED|90.0|-0.5|8.96||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 12.||8.96|-0.50|0.1408
72558250|NCT02554877|144645931|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|4.7|STANDARD_ERROR_OF_MEAN|2.83||0.0986|TWO_SIDED|90.0|0.02|9.38||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 12.||9.38|0.02|0.0986
72558251|NCT02554877|144645931|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|3.79|STANDARD_ERROR_OF_MEAN|2.85||0.1851|TWO_SIDED|90.0|-0.92|8.5||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 12.||8.50|-0.92|0.1851
72558252|NCT02554877|144645932|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|0.39|STANDARD_ERROR_OF_MEAN|2.17||0.8559|TWO_SIDED|90.0|-3.19|3.98||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 2.||3.98|-3.19|0.8559
72384042|NCT01675427|144275986|SUPERIORITY_OR_OTHER|||||||0.0381|TWO_SIDED|||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||G1||||0.0381
72384043|NCT01675427|144275986|SUPERIORITY_OR_OTHER|||||||0.6852|TWO_SIDED|||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||G2||||0.6852
72384044|NCT01675427|144275986|SUPERIORITY_OR_OTHER|||||||0.1185|TWO_SIDED|||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||G3||||0.1185
72384045|NCT01675427|144275987|SUPERIORITY_OR_OTHER|||||||0.2611|TWO_SIDED|||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||G4||||0.2611
72384046|NCT01675427|144275987|SUPERIORITY_OR_OTHER|||||||0.6059|TWO_SIDED|||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||Other genotypes||||0.6059
72384047|NCT01675427|144275987|SUPERIORITY_OR_OTHER|||||||0.0001|TWO_SIDED|||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||Total genotypes||||0.0001
72384048|NCT01675427|144275988|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||G1||||< 0.0001
72384049|NCT01675427|144275988|SUPERIORITY_OR_OTHER|||||||0.0048|TWO_SIDED|||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||G2||||0.0048
72384050|NCT01675427|144275988|SUPERIORITY_OR_OTHER|||||||0.5127|TWO_SIDED|||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||G3||||0.5127
72384051|NCT01675427|144275989|SUPERIORITY_OR_OTHER|||||||0.3465|TWO_SIDED|||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||G4||||0.3465
72384052|NCT01675427|144275989|SUPERIORITY_OR_OTHER|||||||0.7358|TWO_SIDED|||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||Other genotypes||||0.7358
72384053|NCT01675427|144275989|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||Total genotypes||||< 0.0001
72436133|NCT03224299|144385099|SUPERIORITY||Mean Difference (Final Values)|2.33|||||TWO_SIDED|95.0|1.72|2.93||||||Groin 10 minutes Average treatment effect, calculated using a linear regression model for each body site, was used for primary analysis. In the model, the response was the post-treatment log10 bacterial counts and predictors were the treatment effect as a fixed effect and the pre-treatment log10 bacterial counts as a covariate.||2.93|1.72|
72436134|NCT03224299|144385099|NON_INFERIORITY|Investigational product cannot be more than 0.05 log10 CFU/cm\^2 less than the active control|Mean Difference (Final Values)|-0.35|||||TWO_SIDED|95.0|-0.91|0.22||||||Abdomen 30 seconds Average treatment effect, calculated using a linear regression model for each body site, was used for primary analysis. In the model, the response was the post-treatment log10 bacterial counts and predictors were the treatment effect as a fixed effect and the pre-treatment log10 bacterial counts as a covariate.||0.22|-0.91|
72384054|NCT01675427|144275990|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Pearson Chi-Square Tests for association between the two variables|Chi-squared|||||||< 0.0001
72384055|NCT01675427|144275991|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Pearson Chi-Square Tests for association between the two variables|Chi-squared|||||||< 0.0001
72384056|NCT01675427|144275992|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Pearson Chi-Square Tests for association between the two variables|Chi-squared|||||||< 0.0001
72384057|NCT01675427|144275993|SUPERIORITY_OR_OTHER|||||||0.0066|TWO_SIDED|||||Pearson Chi-Square Tests for association between the two variables|Chi-squared|||||||0.0066
72436135|NCT03224299|144385099|SUPERIORITY||Mean Difference (Final Values)|2.45|||||TWO_SIDED|95.0|1.88|3.01||||||Abdomen 30 seconds Average treatment effect, calculated using a linear regression model for each body site, was used for primary analysis. In the model, the response was the post-treatment log10 bacterial counts and predictors were the treatment effect as a fixed effect and the pre-treatment log10 bacterial counts as a covariate.||3.01|1.88|
72494437|NCT03823391|144518005|SUPERIORITY||LS Mean Difference|-1.08|STANDARD_ERROR_OF_MEAN|3.205||0.737|TWO_SIDED|90.0|-6.47|4.3|||Mixed Effect Model Repeated Measurement|Analysis includes treatment, visit, stratification factors, and treatment-by-visit interaction as fixed factors and Baseline value as covariate.|Treatment difference = ABBV-3373 - Adalimumab|||4.30|-6.47|0.737
72494438|NCT03823391|144518006|SUPERIORITY||LS Mean Difference|-0.21|STANDARD_ERROR_OF_MEAN|0.418||0.612|TWO_SIDED|90.0|-0.92|0.49|||Mixed Effect Model Repeated Measurement|Analysis included treatment, visit, stratification factors, and treatment-by-visit interaction as fixed factors and Baseline value as covariate.|Treatment difference = ABBV-3373 - Adalimumab|||0.49|-0.92|0.612
72494439|NCT03823391|144518007|SUPERIORITY||Response Rate Difference|-4.0||||0.877|TWO_SIDED|90.0|-28.5|20.5|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratification factors.|Response rate difference = ABBV-3373 - Adalimumab|||20.5|-28.5|0.877
72494440|NCT03823391|144518008|SUPERIORITY||Response Rate Difference|-13.1||||0.426|TWO_SIDED|90.0|-37.2|11.0|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusting for stratification factors.|Response rate difference = ABBV-3373 - Adalimumab|||11.0|-37.2|0.426
72436136|NCT03224299|144385099|NON_INFERIORITY|Investigational product cannot be more than 0.05 log10 CFU/cm\^2 less than the active control|Mean Difference (Final Values)|-0.31|||||TWO_SIDED|95.0|-0.85|0.24||||||Abdomen 30 seconds Average treatment effect, calculated using a linear regression model for each body site, was used for primary analysis. In the model, the response was the post-treatment log10 bacterial counts and predictors were the treatment effect as a fixed effect and the pre-treatment log10 bacterial counts as a covariate.||0.24|-0.85|
72436137|NCT03224299|144385099|SUPERIORITY||Mean Difference (Final Values)|2.41|||||TWO_SIDED|95.0|1.87|2.95||||||Abdomen 30 seconds Average treatment effect, calculated using a linear regression model for each body site, was used for primary analysis. In the model, the response was the post-treatment log10 bacterial counts and predictors were the treatment effect as a fixed effect and the pre-treatment log10 bacterial counts as a covariate.||2.95|1.87|
72436138|NCT03224299|144385099|NON_INFERIORITY|Investigational product cannot be more than 0.05 log10 CFU/cm\^2 less than the active control|Mean Difference (Final Values)|-0.14|||||TWO_SIDED|95.0|-0.67|0.4||||||Groin 30 seconds Average treatment effect, calculated using a linear regression model for each body site, was used for primary analysis. In the model, the response was the post-treatment log10 bacterial counts and predictors were the treatment effect as a fixed effect and the pre-treatment log10 bacterial counts as a covariate.||0.40|-0.67|
72436139|NCT03224299|144385099|SUPERIORITY||Mean Difference (Final Values)|2.25|||||TWO_SIDED|95.0|1.7|2.8||||||Groin 30 seconds Average treatment effect, calculated using a linear regression model for each body site, was used for primary analysis. In the model, the response was the post-treatment log10 bacterial counts and predictors were the treatment effect as a fixed effect and the pre-treatment log10 bacterial counts as a covariate.||2.80|1.70|
72494441|NCT05218499|144518029|OTHER||Hazard Ratio (HR)|0.79||||0.0956|TWO_SIDED|95.0|0.6|1.06|||Regression, Cox||A hazard ratio value below 1 favors brigimadlin.|The primary estimator for the hazard ratio is the median unbiased estimator. The confidence interval (CI) for the hazard ratio is calculated as a repeated CI. The p-value is obtained using a weighted inverse normal method combining one-sided p-values from two stages.||1.06|0.60|0.0956
72494442|NCT05218499|144518030|OTHER||Odds Ratio (OR)|2.93|||||TWO_SIDED|95.0|1.52|5.67|||||An odds ratio value greater than 1 favors brigimadlin.|The primary estimator and CI for the odds ratio is by Cochran-Mantel-Haenszel.||5.67|1.52|
72494443|NCT05218499|144518032|OTHER||Odds Ratio (OR)|1.51|||||TWO_SIDED|95.0|0.81|2.82|||||An odds ratio value greater than 1 favors brigimadlin.|Odds ratios are calculated from a logistic regression model with the stratification factor (locally advanced vs. metastatic) included as a covariate.||2.82|0.81|
72494444|NCT05218499|144518032|OTHER||Odds Ratio (OR)|2.67|||||TWO_SIDED|95.0|1.48|4.84|||||An odds ratio value greater than 1 favors brigimadlin.|Odds ratios are calculated from a logistic regression model with the stratification factor (locally advanced vs. metastatic) included as a covariate. Exact 95% confidence interval (CI) by Clopper and Pearson.||4.84|1.48|
72494445|NCT03946670|144518034|SUPERIORITY|||||||0.769|||||||Cochran-Mantel-Haenszel|stratified by the randomization stratification factor IPSS-R category||||||0.769
72494446|NCT03946670|144518035|SUPERIORITY||Cox Proportional Hazard|0.749||||0.1022|TWO_SIDED|95.0|0.479|1.173|||Log Rank|stratified by the randomization stratification factor IPSS-R category||||1.173|0.479|0.1022
72494447|NCT05030311|144518100|SUPERIORITY||Mean Difference (Final Values)|-6.22|STANDARD_ERROR_OF_MEAN|1.136|<|0.001|TWO_SIDED|95.0|-8.45|-4.0|||Mixed Models Analysis||MMRM adjusting for treatment arm, geographical region, prior exposure to anti-IgE biologics, visit week, baseline score and both interaction of treatment by visit week and interaction of baseline score by visit week.|||-4.00|-8.45|<0.001
72494448|NCT05030311|144518101|SUPERIORITY||Mean Difference (Final Values)|-2.63|STANDARD_ERROR_OF_MEAN|0.544|<|0.001|TWO_SIDED|95.0|-3.7|-1.56|||Mixed Models Analysis||MMRM adjusting for treatment arm, geographical region, prior exposure to anti-IgE biologics, visit week, baseline score and both interaction of treatment by visit week and interaction of baseline score by visit week.|ISS7 at Week 12 (Scenario 2 with ISS7 and HSS7 as co-primary efficacy endpoints)||-1.56|-3.70|<0.001
72494449|NCT05030311|144518102|SUPERIORITY||Mean Difference (Final Values)|-3.61|STANDARD_ERROR_OF_MEAN|0.635|<|0.001|TWO_SIDED|95.0|-4.85|-2.36|||Mixed Models Analysis||MMRM adjusting for treatment arm, geographical region, prior exposure to anti-IgE biologics, visit week, baseline score and both interaction of treatment by visit week and interaction of baseline score by visit week.|HSS7 at Week 12 (Scenario 2 with ISS7 and HSS7 as co-primary efficacy endpoints)||-2.36|-4.85|<0.001
72494450|NCT05030311|144518103|SUPERIORITY||Odds Ratio (OR)|3.11|||<|0.001|TWO_SIDED|95.0|2.0|4.84|||Regression, Logistic|Logistic regression adjusting for treatment arm, geographical region, prior exposure to anti-IgE biologics, and baseline UAS7 score.||Disease activity control (UAS7 =\< 6) at Week 12||4.84|2.00|<0.001
72504615|NCT01582282|144540045|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|40.72||||0.009|||||||ANCOVA|||||||0.009
72504616|NCT01582282|144540046|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.53||||0.013|||||||ANCOVA|||||||0.013
72436140|NCT03224299|144385099|NON_INFERIORITY|Investigational product cannot be more than 0.05 log10 CFU/cm\^2 less than the active control|Mean Difference (Final Values)|-0.04|||||TWO_SIDED|95.0|-0.56|0.48||||||Groin 30 seconds Average treatment effect, calculated using a linear regression model for each body site, was used for primary analysis. In the model, the response was the post-treatment log10 bacterial counts and predictors were the treatment effect as a fixed effect and the pre-treatment log10 bacterial counts as a covariate.||0.48|-0.56|
72436141|NCT03224299|144385099|SUPERIORITY||Mean Difference (Final Values)|2.15|||||TWO_SIDED|95.0|1.62|2.68||||||Groin 30 seconds Average treatment effect, calculated using a linear regression model for each body site, was used for primary analysis. In the model, the response was the post-treatment log10 bacterial counts and predictors were the treatment effect as a fixed effect and the pre-treatment log10 bacterial counts as a covariate.||2.68|1.62|
72384058|NCT01675427|144275994|SUPERIORITY_OR_OTHER|||||||0.0018|TWO_SIDED|||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||G1||||0.0018
72384059|NCT01675427|144275994|SUPERIORITY_OR_OTHER|||||||0.0425|TWO_SIDED|||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||G2||||0.0425
72384060|NCT01675427|144275994|SUPERIORITY_OR_OTHER|||||||0.9829|TWO_SIDED|||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||G3||||0.9829
72384061|NCT01675427|144275994|SUPERIORITY_OR_OTHER|||||||0.67|TWO_SIDED|||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||G4||||0.6700
72384062|NCT01675427|144275994|SUPERIORITY_OR_OTHER|||||||0.7672|TWO_SIDED|||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||Other genotypes||||0.7672
72384063|NCT01675427|144275994|SUPERIORITY_OR_OTHER|||||||0.0067|TWO_SIDED|||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||Total genotypes||||0.0067
72384064|NCT01675427|144275995|SUPERIORITY_OR_OTHER|||||||0.0003|TWO_SIDED|||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||G1||||0.0003
72384065|NCT01675427|144275995|SUPERIORITY_OR_OTHER|||||||0.1637|TWO_SIDED|||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||G2||||0.1637
72384066|NCT01675427|144275995|SUPERIORITY_OR_OTHER|||||||0.8579|TWO_SIDED|||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||G3||||0.8579
72384067|NCT01675427|144275995|SUPERIORITY_OR_OTHER|||||||0.6935|TWO_SIDED|||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||G4||||0.6935
72384068|NCT01675427|144275995|SUPERIORITY_OR_OTHER|||||||0.8124|TWO_SIDED|||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||Other genotypes||||0.8124
72384069|NCT01675427|144275995|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||Total genotypes||||< 0.0001
72384070|NCT01675427|144275996|SUPERIORITY_OR_OTHER|||||||0.1834|TWO_SIDED|||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||G1||||0.1834
72384071|NCT01675427|144275996|SUPERIORITY_OR_OTHER|||||||0.8543|TWO_SIDED|||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||G2||||0.8543
72384072|NCT01675427|144275996|SUPERIORITY_OR_OTHER|||||||0.1485|TWO_SIDED|||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||G3||||0.1485
72384073|NCT01675427|144275996|SUPERIORITY_OR_OTHER|||||||0.026|TWO_SIDED|||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||G4||||0.0260
72384074|NCT01675427|144275996|SUPERIORITY_OR_OTHER|||||||0.5317|TWO_SIDED|||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||Other genotypes||||0.5317
72384075|NCT01675427|144275996|SUPERIORITY_OR_OTHER|||||||0.0005|TWO_SIDED|||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||Total genotypes||||0.0005
72384076|NCT01675427|144275997|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||G1||||< 0.0001
72384077|NCT01675427|144275997|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||G2||||< 0.0001
72384078|NCT01675427|144275997|SUPERIORITY_OR_OTHER|||||||0.4423|TWO_SIDED|||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||G3||||0.4423
72384079|NCT01675427|144275997|SUPERIORITY_OR_OTHER|||||||0.3824|TWO_SIDED|||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||G4||||0.3824
72384080|NCT01675427|144275997|SUPERIORITY_OR_OTHER|||||||0.5246|TWO_SIDED|||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||Other genotypes||||0.5246
72384081|NCT01675427|144275997|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||Total genotypes||||< 0.0001
72436142|NCT00959920|144385106|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.8||||0.42|TWO_SIDED||||||t-test, 2 sided|||The null hypothesis is that patients for whom indwelling foley catheterization was employed will have their time to delivery interval reduced by 30 minutes.||||.42
72494451|NCT05030311|144518104|SUPERIORITY||Odds Ratio (OR)|3.83|||<|0.001|TWO_SIDED|95.0|2.16|6.82|||Regression, Logistic|Logistic regression adjusting for treatment arm, geographical region, prior exposure to anti-IgE biologics, and baseline UAS7 score.||Complete absence of hives and itch (UAS7 = 0) at Week 12||6.82|2.16|<0.001
72494452|NCT05030311|144518105|SUPERIORITY||Odds Ratio (OR)|15.67|||<|0.001|TWO_SIDED|95.0|6.18|39.77|||Regression, Logistic||Statistical model used logistic regression adjusting for treatment arm, geographical region, prior exposure to anti-IgE biologics, and baseline UAS7 score.|||39.77|6.18|<0.001
72494453|NCT05030311|144518106|SUPERIORITY||Rate ratio|2.69|||<|0.001|TWO_SIDED|95.0|2.01|3.61|||Negative binomial regression model|Negative binomial regression model with log link, using treatment arm, geographical region, and prior exposure to anti-IgE biologics as covariates.||||3.61|2.01|<0.001
72494454|NCT05030311|144518107|SUPERIORITY||Odds Ratio (OR)|2.44|||<|0.001|TWO_SIDED|95.0|1.53|3.9|||Regression, Logistic||Statistical model used logistic regression adjusting for treatment arm, geographical region, prior exposure to anti-IgE biologics and baseline DLQI score.|||3.90|1.53|<0.001
72494455|NCT05030311|144518108|SUPERIORITY||Rate ratio|1.25|||<|0.001|TWO_SIDED|95.0|1.12|1.41|||Regression, Linear||Statistical model used a negative binomial regression with log link included treatment arm as fixed effect, geographical region, prior exposure to anti-IgE biologics, baseline AAS7 = 0 response as covariates.|Angioedema occurrence-free weeks (AAS7 = 0 response) up to Week 12||1.41|1.12|<0.001
72494456|NCT03083886|144518121|SUPERIORITY||Risk Ratio (RR)|0.93||||0.04|TWO_SIDED|95.0|0.87|0.997|||GEE with log link and Poisson errors|||||.997|.87|.04
72494457|NCT03083886|144518121|SUPERIORITY||Risk Ratio (RR)|1.4|||<|0.001|TWO_SIDED|95.0|1.35|1.45|||GEE with log link and Poisson errors|||||1.45|1.35|<0.001
72494458|NCT03083886|144518122|SUPERIORITY||Risk Difference (RD)|-5.8|||<|0.001|TWO_SIDED|95.0|-7.7|-3.9|||GEE with identity link and normal errors|||||-3.9|-7.7|<0.001
72494459|NCT03083886|144518122|SUPERIORITY||Risk Difference (RD)|-4.3|||<|0.001|TWO_SIDED|95.0|-5.9|-2.6|||GEE with identity link and normal errors|||||-2.6|-5.9|<0.001
72494460|NCT03083886|144518123|SUPERIORITY||Risk Difference (RD)|-7.5|||<|0.001|TWO_SIDED|95.0|-9.4|-5.7|||GEE with identity link and normal errors|||||-5.7|-9.4|<0.001
72494461|NCT03083886|144518123|SUPERIORITY||Risk Difference (RD)|-6.7|||<|0.001|TWO_SIDED|95.0|-8.4|-5.0|||GEE with identity link and normal errors|||||-5.0|-8.4|<0.001
72494462|NCT03083886|144518124|SUPERIORITY||Risk Difference (RD)|4.7|||<|0.001|TWO_SIDED|95.0|2.6|6.8|||GEE with identity link and normal errors|||||6.8|2.6|<0.001
72494463|NCT03083886|144518124|SUPERIORITY||Risk Difference (RD)|6.0|||<|0.001|TWO_SIDED|95.0|4.1|7.9|||GEE with identity link and normal errors|||||7.9|4.1|<0.001
72494464|NCT03083886|144518125|SUPERIORITY||Risk Difference (RD)|6.8|||<|0.001|TWO_SIDED|95.0|5.0|8.7|||GEE with identity link and normal errors|||||8.7|5.0|<0.001
72494465|NCT03083886|144518125|SUPERIORITY||Risk Difference (RD)|6.7|||<|0.001|TWO_SIDED|95.0|5.0|8.4|||GEE with identity link and normal errors|||||8.4|5.0|<0.001
72494466|NCT04161495|144518128|NON_INFERIORITY|Non-inferiority would be established if the upper bound of the one-sided 97.5% CI was less than 4.|Mean difference|-2.3|||||TWO_SIDED|95.0|-3.49|-1.11||||||Hierarchical testing framework: used to control type I error for secondary OM analyses. Statistical testing of Arm A intra-participant comparison non-inferiority continued only when estimation of previous OM was statistically significant at 0.05 level. For Arm A intra-participant comparison, mean difference and 95% confidence interval (CI) were estimated by NB regression model in which treatment (BIVV001 prophylaxis vs historical prophylaxis vs historical prophylaxis) was treated as covariate.||-1.11|-3.49|
72494467|NCT04161495|144518130|SUPERIORITY|Superiority was declared if the upper bound of the one-sided 97.5% confidence interval was less than 1.|Rate ratio|0.23|||<|0.0001|TWO_SIDED|95.0|0.13|0.42|||Negative binomial regression mode|||Tested according to hierarchical testing procedure (only performed if the previous OM was statistically significant for the considered dosing regimen). For test about Arm A intra-participant comparison superiority, rate ratio and 95% CI were estimated using NB regression model in which treatment (BIVV001 prophylaxis vs historical prophylaxis) was treated as covariate.||0.42|0.13|<0.0001
72494468|NCT04161495|144518132|SUPERIORITY||LS mean difference|-6.74|STANDARD_ERROR_OF_MEAN|1.71||0.0001|TWO_SIDED|95.0|-10.13|-3.36|||Unstructured covariance matrix|An unstructured covariance matrix within a participant was used.||Testing according to hierarchical testing procedure. Only performed if previous OM \[Annualized Bleeding Rate During the Efficacy Period in Prophylaxis Arm - Superiority Analysis\] was statistically significant for considered dosing regimen). Least square (LS) mean difference, standard error and 95% confidence interval were estimated by mixed-effect model with repeated measures (MMRM) using visit as fixed effect and Baseline Haem-A-QOL physical health score as covariate.||-3.36|-10.13|0.0001
72494469|NCT04161495|144518133|SUPERIORITY||LS mean difference|-1.94|STANDARD_ERROR_OF_MEAN|0.67||0.0042|TWO_SIDED|95.0|-3.26|-0.63|||Unstructured covariance matrix|An unstructured covariance matrix within a participant was used.||Testing according to hierarchical testing procedure. Only performed if previous OM \[Change From Baseline in Haem-A-QOL Physical Health Score at Weeks 26 and 52: Prophylaxis Arm\] was statistically significant for considered dosing regimen). LS mean difference, standard error and 95% confidence interval were estimated by MMRM using visit as fixed effect and PROMIS Pain Intensity 3a score as covariate.||-0.63|-3.26|0.0042
72494470|NCT04161495|144518134|SUPERIORITY||LS mean difference|-1.54|STANDARD_ERROR_OF_MEAN|0.59||0.0101|TWO_SIDED|95.0|-2.7|-0.37||An unstructured covariance matrix within a participant was used.|Unstructured covariance matrix|||Testing according to hierarchical testing procedure (only performed if previous OM \[Change From Baseline in PROMIS Pain Intensity 3a First Item at Week 52: Prophylaxis Arm\] was statistically significant for considered dosing regimen). LS mean difference, standard error and 95% confidence interval were estimated by MMRM using visit as fixed effect and Baseline Haem-A-QOL physical health score as covariate.||-0.37|-2.70|0.0101
72504617|NCT01582282|144540046|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.65||||0.003|||||||ANCOVA|||||||0.003
72504618|NCT01582282|144540047|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.48||||0.808|||||||ANCOVA|||||||0.808
72504619|NCT01582282|144540047|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.0||||0.328|||||||ANCOVA|||||||0.328
72504620|NCT01582282|144540048|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.1||||0.508|||||||ANCOVA|||||||0.508
72504621|NCT01582282|144540048|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.43||||0.962|||||||ANCOVA|||||||0.962
72504622|NCT01582282|144540049|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.84||||0.363|||||||ANCOVA|||||||0.363
72504623|NCT01582282|144540049|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.24||||0.978|||||||ANCOVA|||||||0.978
72504624|NCT01582282|144540050|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.14||||0.785|||||||ANCOVA|||||||0.785
72504625|NCT01582282|144540050|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.45||||0.811|||||||ANCOVA|||||||0.811
72558253|NCT02554877|144645932|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|2.97|STANDARD_ERROR_OF_MEAN|2.17||0.1729|TWO_SIDED|90.0|-0.62|6.55||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 2.||6.55|-0.62|0.1729
72558254|NCT02554877|144645932|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|8.45|STANDARD_ERROR_OF_MEAN|2.18||0.0002|TWO_SIDED|90.0|4.84|12.06||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 2.||12.06|4.84|0.0002
72558255|NCT02554877|144645932|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|0.37|STANDARD_ERROR_OF_MEAN|2.55||0.8837|TWO_SIDED|90.0|-3.85|4.59||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 4.||4.59|-3.85|0.8837
72558256|NCT02554877|144645932|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|3.62|STANDARD_ERROR_OF_MEAN|2.55||0.1573|TWO_SIDED|90.0|-0.6|7.84||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 4.||7.84|-0.60|0.1573
72558257|NCT02554877|144645932|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|7.88|STANDARD_ERROR_OF_MEAN|2.56||0.0024|TWO_SIDED|90.0|3.65|12.11||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 4.||12.11|3.65|0.0024
72558258|NCT02554877|144645932|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|3.59|STANDARD_ERROR_OF_MEAN|2.51||0.1538|TWO_SIDED|90.0|-0.55|7.73||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 8.||7.73|-0.55|0.1538
72558259|NCT02554877|144645932|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|4.39|STANDARD_ERROR_OF_MEAN|2.48||0.0789|TWO_SIDED|90.0|0.28|8.49||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 8.||8.49|0.28|0.0789
72384082|NCT01675427|144275998|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||G1||||< 0.0001
72384083|NCT01675427|144275998|SUPERIORITY_OR_OTHER|||||||0.1947|TWO_SIDED|||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||G2||||0.1947
72384084|NCT01675427|144275998|SUPERIORITY_OR_OTHER|||||||0.0226|TWO_SIDED|||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||G3||||0.0226
72384085|NCT01675427|144275999|SUPERIORITY_OR_OTHER|||||||0.1158|TWO_SIDED|||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||G4||||0.1158
72384086|NCT01675427|144275999|SUPERIORITY_OR_OTHER|||||||0.3675|TWO_SIDED|||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||Other genotypes||||0.3675
72436143|NCT03546907|144385129|SUPERIORITY||Risk Ratio (RR)|0.808||||0.1296|TWO_SIDED|95.0|0.613|1.065|||Negative binomial regression model|||Analysis was performed using negative binomial regression model with total number of events occurring during observation duration as response variable, treatment, baseline eosinophil strata, region, number of severe COPD exacerbations experienced in previous year(0 vs. 1+) at baseline, smoking history(current vs. former smoker), post-BD FEV1 percent(%) predicted (less than\[\<\] 50% vs greater than equal\[\>=\]50%) at baseline as covariates, and log-transformed observation duration as offset variable.||1.065|0.613|0.1296
72436144|NCT03110458|144385163|SUPERIORITY|||||||0.8466|||||||ANCOVA|||||||0.8466
72384087|NCT01675427|144275999|SUPERIORITY_OR_OTHER|||||||0.0948|TWO_SIDED|||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||Total genotypes||||0.0948
72384088|NCT01675427|144276000|SUPERIORITY_OR_OTHER|||||||0.1236|TWO_SIDED|||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||G1||||0.1236
72384089|NCT01675427|144276000|SUPERIORITY_OR_OTHER|||||||0.0119|TWO_SIDED|||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||G2||||0.0119
72384090|NCT01675427|144276000|SUPERIORITY_OR_OTHER|||||||0.7472|TWO_SIDED|||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||G3||||0.7472
72384091|NCT01675427|144276001|SUPERIORITY_OR_OTHER|||||||0.9734|TWO_SIDED|||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||G4||||0.9734
72384092|NCT01675427|144276001|SUPERIORITY_OR_OTHER|||||||0.8303|TWO_SIDED|||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||Other genotypes||||0.8303
72384093|NCT01675427|144276001|SUPERIORITY_OR_OTHER|||||||0.0006|TWO_SIDED|||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||Total genotypes||||0.0006
72384094|NCT01675427|144276002|SUPERIORITY_OR_OTHER|||||||0.0065|TWO_SIDED|||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||G1||||0.0065
72436145|NCT03110458|144385164|SUPERIORITY|||||||0.9538|||||||ANCOVA|||||||0.9538
72436146|NCT03110458|144385165|SUPERIORITY|||||||0.3166|||||||ANCOVA|||||||0.3166
72436147|NCT03110458|144385166|SUPERIORITY|||||||0.393|||||||ANCOVA|||||||0.393
72436148|NCT03110458|144385169|SUPERIORITY|||||||0.5324|||||||ANCOVA|||||||0.5324
72558260|NCT02554877|144645932|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|10.14|STANDARD_ERROR_OF_MEAN|2.51|<|0.0001|TWO_SIDED|90.0|5.98|14.3||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 8.||14.30|5.98|<0.0001
72618752|NCT01026038|144768109|SUPERIORITY_OR_OTHER||GMT ratio|1.1|||||TWO_SIDED|95.0|0.82|1.38||||||Serotype 7F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.38|0.82|
72384095|NCT01675427|144276002|SUPERIORITY_OR_OTHER|||||||0.9999|TWO_SIDED|||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||G2||||0.9999
72384096|NCT01675427|144276002|SUPERIORITY_OR_OTHER|||||||0.3472|TWO_SIDED|||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||G3||||0.3472
72384097|NCT01675427|144276003|SUPERIORITY_OR_OTHER|||||||0.2564|TWO_SIDED|||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||G4||||0.2564
72384098|NCT01675427|144276003|SUPERIORITY_OR_OTHER|||||||0.7361|TWO_SIDED|||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||Other genotypes||||0.7361
72384099|NCT01675427|144276003|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||Total genotypes||||< 0.0001
72436149|NCT03923491|144385178|SUPERIORITY||Slope|-0.55|STANDARD_ERROR_OF_MEAN|4.69||1|TWO_SIDED|||||Familywise error rates were controlled at alpha=.05 for primary and secondary outcomes separately using Holm's sequentially rejective procedure.|Regression, Linear|||Inverse probability of retention weighted normal linear regression models for between-arm differences in HEI-2015 total score controlling for baseline HEI-2015 saturated fat, child involvement in food preparation, and receipt of any food assistance.||||1.00
72436150|NCT03923491|144385178|SUPERIORITY||Slope|-0.35|STANDARD_ERROR_OF_MEAN|0.49||1|TWO_SIDED|||||Familywise error rates were controlled at alpha=.05 for primary and secondary outcomes separately using Holm's sequentially rejective procedure.|Regression, Linear|||Inverse probability of retention weighted normal linear regression models for between-arm differences in HEI-2015 total vegetable component controlling for baseline HEI-2015 saturated fat, child involvement in food preparation, and receipt of any food assistance.||||1.00
72436151|NCT03923491|144385178|SUPERIORITY||Slope|0.06|STANDARD_ERROR_OF_MEAN|0.88||0.2|TWO_SIDED|||||Familywise error rates were controlled at alpha=.05 for primary and secondary outcomes separately using Holm's sequentially rejective procedure.|Regression, Linear|||Inverse probability of retention weighted normal linear regression models for between-arm differences in HEI-2015 greens and beans component controlling for baseline HEI-2015 saturated fat, child involvement in food preparation, and receipt of any food assistance.||||0.20
72436152|NCT03923491|144385178|SUPERIORITY||Slope|1.71|STANDARD_ERROR_OF_MEAN|0.67||0.2|TWO_SIDED|||||Familywise error rates were controlled at alpha=.05 for primary and secondary outcomes separately using Holm's sequentially rejective procedure.|Regression, Linear|||Inverse probability of retention weighted normal linear regression models for between-arm differences in HEI-2015 total fruit component controlling for baseline HEI-2015 saturated fat, child involvement in food preparation, and receipt of any food assistance.||||0.20
72436153|NCT03923491|144385178|SUPERIORITY||Slope|2.14|STANDARD_ERROR_OF_MEAN|0.83||0.19|TWO_SIDED|||||Familywise error rates were controlled at alpha=.05 for primary and secondary outcomes separately using Holm's sequentially rejective procedure.|Regression, Linear|||Inverse probability of retention weighted normal linear regression models for between-arm differences in HEI-2015 whole fruit component controlling for baseline HEI-2015 saturated fat, child involvement in food preparation, and receipt of any food assistance.||||0.19
72436154|NCT03923491|144385178|SUPERIORITY||Slope|0.83|STANDARD_ERROR_OF_MEAN|1.1||1|TWO_SIDED|||||Familywise error rates were controlled at alpha=.05 for primary and secondary outcomes separately using Holm's sequentially rejective procedure.|Regression, Linear|||Inverse probability of retention weighted normal linear regression models for between-arm differences in HEI-2015 whole grain component controlling for baseline HEI-2015 saturated fat, child involvement in food preparation, and receipt of any food assistance.||||1.0
72384100|NCT01675427|144276004|SUPERIORITY_OR_OTHER|||||||0.0097|TWO_SIDED|||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||G1||||0.0097
72384101|NCT01675427|144276004|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||G2||||< 0.0001
72384102|NCT01675427|144276004|SUPERIORITY_OR_OTHER|||||||0.9778|TWO_SIDED|||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||G3||||0.9778
72384103|NCT01675427|144276005|SUPERIORITY_OR_OTHER|||||||0.0151|TWO_SIDED|||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||G4||||0.0151
72384104|NCT01675427|144276005|SUPERIORITY_OR_OTHER|||||||0.1052|TWO_SIDED|||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||Other genotypes||||0.1052
72384105|NCT01675427|144276005|SUPERIORITY_OR_OTHER|||||||0.0007|TWO_SIDED|||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||Total genotypes||||0.0007
72384106|NCT01675427|144276006|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G1||||< 0.0001
72384107|NCT01675427|144276006|SUPERIORITY_OR_OTHER|||||||0.0012|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G2||||0.0012
72384108|NCT01675427|144276006|SUPERIORITY_OR_OTHER|||||||0.1717|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G3||||0.1717
72384109|NCT01675427|144276006|SUPERIORITY_OR_OTHER|||||||0.0253|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G4||||0.0253
72384110|NCT01675427|144276007|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G1||||< 0.0001
72384111|NCT01675427|144276007|SUPERIORITY_OR_OTHER|||||||0.033|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G2||||0.0330
72384112|NCT01675427|144276007|SUPERIORITY_OR_OTHER|||||||0.1595|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G3||||0.1595
72384113|NCT01675427|144276007|SUPERIORITY_OR_OTHER|||||||0.0412|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G4||||0.0412
72384114|NCT01675427|144276008|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three IL28B genotype categories|Cochran-Armitage Trend Test|||G1||||< 0.0001
72384115|NCT01675427|144276008|SUPERIORITY_OR_OTHER|||||||0.0421|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three IL28B genotype categories|Cochran-Armitage Trend Test|||G2||||0.0421
72436155|NCT03923491|144385178|SUPERIORITY||Slope|-0.9|STANDARD_ERROR_OF_MEAN|0.85||1|TWO_SIDED|||||Familywise error rates were controlled at alpha=.05 for primary and secondary outcomes separately using Holm's sequentially rejective procedure.|Regression, Linear|||Inverse probability of retention weighted normal linear regression models for between-arm differences in HEI-2015 total dairy component controlling for baseline HEI-2015 saturated fat, child involvement in food preparation, and receipt of any food assistance.||||1.0
72436156|NCT03923491|144385178|SUPERIORITY||Slope|0.22|STANDARD_ERROR_OF_MEAN|0.42||1|TWO_SIDED|||||Familywise error rates were controlled at alpha=.05 for primary and secondary outcomes separately using Holm's sequentially rejective procedure.|Regression, Linear|||Inverse probability of retention weighted normal linear regression models for between-arm differences in HEI-2015 total protein foods component controlling for baseline HEI-2015 saturated fat, child involvement in food preparation, and receipt of any food assistance.||||1.00
72384116|NCT01675427|144276008|SUPERIORITY_OR_OTHER|||||||0.7658|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three IL28B genotype categories|Cochran-Armitage Trend Test|||G3||||0.7658
72384117|NCT01675427|144276008|SUPERIORITY_OR_OTHER|||||||0.295|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three IL28B genotype categories|Cochran-Armitage Trend Test|||G4||||0.2950
72384118|NCT01675427|144276009|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three IL28B genotype categories|Cochran-Armitage Trend Test|||G1||||< 0.0001
72384119|NCT01675427|144276009|SUPERIORITY_OR_OTHER|||||||0.0827|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three IL28B genotype categories|Cochran-Armitage Trend Test|||G2||||0.0827
72384120|NCT01675427|144276009|SUPERIORITY_OR_OTHER|||||||0.7817|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three IL28B genotype categories|Cochran-Armitage Trend Test|||G3||||0.7817
72384121|NCT01675427|144276009|SUPERIORITY_OR_OTHER|||||||0.1986|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three IL28B genotype categories|Cochran-Armitage Trend Test|||G4||||0.1986
72436157|NCT03923491|144385178|SUPERIORITY||Slope|-0.12|STANDARD_ERROR_OF_MEAN|0.85||-0.12|TWO_SIDED|||||Familywise error rates were controlled at alpha=.05 for primary and secondary outcomes separately using Holm's sequentially rejective procedure.|Regression, Linear|||Inverse probability of retention weighted normal linear regression models for between-arm differences in HEI-2015 seafood and plant protein component controlling for baseline HEI-2015 saturated fat, child involvement in food preparation, and receipt of any food assistance.||||-0.12
72436158|NCT03923491|144385178|SUPERIORITY||Slope|-0.31|STANDARD_ERROR_OF_MEAN|1.12||1|TWO_SIDED|||||Familywise error rates were controlled at alpha=.05 for primary and secondary outcomes separately using Holm's sequentially rejective procedure.|Regression, Linear|||Inverse probability of retention weighted normal linear regression models for between-arm differences in HEI-2015 fatty acid component controlling for baseline HEI-2015 saturated fat, child involvement in food preparation, and receipt of any food assistance.||||1.00
72384122|NCT01675427|144276010|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G1||||< 0.0001
72384123|NCT01675427|144276010|SUPERIORITY_OR_OTHER|||||||0.0002|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G2||||0.0002
72384124|NCT01675427|144276010|SUPERIORITY_OR_OTHER|||||||0.0394|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G3||||0.0394
72384125|NCT01675427|144276010|SUPERIORITY_OR_OTHER|||||||0.0493|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G4||||0.0493
72384126|NCT01675427|144276011|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G1||||< 0.0001
72384127|NCT01675427|144276011|SUPERIORITY_OR_OTHER|||||||0.0196|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G2||||0.0196
72384128|NCT01675427|144276011|SUPERIORITY_OR_OTHER|||||||0.3268|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G3||||0.3268
72384129|NCT01675427|144276011|SUPERIORITY_OR_OTHER|||||||0.1667|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G4||||0.1667
72384130|NCT01675427|144276012|SUPERIORITY_OR_OTHER|||||||0.0021|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three ITPA genotype categories|Cochran-Armitage Trend Test|||G1||||0.0021
72384131|NCT01675427|144276012|SUPERIORITY_OR_OTHER|||||||0.5319|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three ITPA genotype categories|Cochran-Armitage Trend Test|||G2||||0.5319
72618753|NCT01026038|144768109|SUPERIORITY_OR_OTHER||GMT ratio|2.0|||||TWO_SIDED|95.0|1.46|2.69||||||Serotype 7F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||2.69|1.46|
72436159|NCT03923491|144385178|SUPERIORITY||Slope|-2.09|STANDARD_ERROR_OF_MEAN|0.97||1|TWO_SIDED|||||Familywise error rates were controlled at alpha=.05 for primary and secondary outcomes separately using Holm's sequentially rejective procedure.|Regression, Linear|||Inverse probability of retention weighted normal linear regression models for between-arm differences in HEI-2015 sodium component controlling for baseline HEI-2015 saturated fat, child involvement in food preparation, and receipt of any food assistance.||||1.00
72436160|NCT03923491|144385178|SUPERIORITY||Slope|-0.8|STANDARD_ERROR_OF_MEAN|1.16||1|TWO_SIDED|||||Familywise error rates were controlled at alpha=.05 for primary and secondary outcomes separately using Holm's sequentially rejective procedure.|Regression, Linear|||Inverse probability of retention weighted normal linear regression models for between-arm differences in HEI-2015 refined grains component controlling for baseline HEI-2015 saturated fat, child involvement in food preparation, and receipt of any food assistance.||||1.00
72436161|NCT03923491|144385178|SUPERIORITY||Slope|-0.28|STANDARD_ERROR_OF_MEAN|1.13||1|TWO_SIDED|||||Familywise error rates were controlled at alpha=.05 for primary and secondary outcomes separately using Holm's sequentially rejective procedure.|Regression, Linear|||Inverse probability of retention weighted normal linear regression models for between-arm differences in HEI-2015 added sugar component controlling for baseline HEI-2015 saturated fat, child involvement in food preparation, and receipt of any food assistance.||||1.00
72436162|NCT03923491|144385178|SUPERIORITY||Slope|-0.52|STANDARD_ERROR_OF_MEAN|0.86||1|TWO_SIDED|||||Familywise error rates were controlled at alpha=.05 for primary and secondary outcomes separately using Holm's sequentially rejective procedure.|Regression, Linear|||||||1.00
72436163|NCT02633358|144385181|SUPERIORITY|Therapeutic hypothermia need to have superiority in the survival rate after 90 days|Risk Ratio (RR)|0.58|||<|0.001|TWO_SIDED|95.0|0.41|0.82||P-value less than 0.05 means significant data|Chi-squared|Test method for proportional data||Therapeutic hypothermia group compare with control group||0.82|0.41|<0.001
72436164|NCT02633358|144385182|SUPERIORITY|Therapeutic hypothermia nee to have superiority in neurological outcome in the 90 days after enrollment.|Risk Ratio (RR)|0.8||||0.04|TWO_SIDED|95.0|0.66|0.98||P value less than 0.05 means significant date|Chi-squared|Test method for proportional data||Therapeutic hypothermia group compare with control group||0.98|0.66|0.04
72436165|NCT02633358|144385183|SUPERIORITY||||||<|0.05||||||P-value less than 0.05 is statistical significance.|t-test, 2 sided|||||||<0.05
72436166|NCT02633358|144385184|SUPERIORITY||||||<|0.05||||||P-value less than 0.05 is statistical significance.|t-test, 2 sided|||||||<0.05
72436167|NCT02633358|144385185|SUPERIORITY||||||<|0.05||||||P-value less then 0.05 is statistical significance.|t-test, 2 sided|||||||<0.05
72436168|NCT00470106|144385252|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Not corrected for multiple comparisons because it is primary.|mixed model|same analysis as for secondary outcome variable.||||||<.001
72436169|NCT00470106|144385253|SUPERIORITY_OR_OTHER||||||<|0.1||||||A priori threshold for significance was P \< .05|mixed model|Same as for the primary variable.||||||<.10
72436170|NCT03621761|144385254|SUPERIORITY||Slope|1.774||||0.3451|TWO_SIDED||||||Regression, Linear|||Comparison of treatment effect of CBT monotherapy vs. combination therapy (reference) on total MFIS score, in linear regression models adjusted for age, sex, anxiety, pain, activity level, study site, and baseline MFIS score. Output reflects models that were imputed for missing data.||||0.3451
72436171|NCT03621761|144385254|SUPERIORITY||Slope|1.3094||||0.4834|TWO_SIDED||||||Regression, Linear|||Comparison of treatment effect of modafinil monotherapy vs. combination therapy (reference) on total MFIS score, in linear regression models adjusted for age, sex, anxiety, pain, activity level, study site, and baseline MFIS score. Output reflects models that were imputed for missing data.||||0.4834
72436172|NCT03621761|144385255|SUPERIORITY||Slope|0.4077||||0.257|TWO_SIDED||||||Regression, Linear|||Comparison of treatment effect of CBT monotherapy vs. combination therapy (reference) on change in EMA fatigue intensity NRS score, in complete case linear regression models adjusted for age, sex, anxiety, pain, activity level, study site, and baseline EMA fatigue intensity score.||||0.2570
72436173|NCT03621761|144385255|SUPERIORITY||Slope|-0.2452||||0.5017|TWO_SIDED||||||Regression, Linear|||Comparison of treatment effect of modafinil monotherapy vs. combination therapy (reference) on change in EMA fatigue intensity NRS score, in complete case linear regression models adjusted for age, sex, anxiety, pain, activity level, study site, and baseline EMA fatigue intensity score.||||0.5017
72436174|NCT03621761|144385256|SUPERIORITY||Slope|0.095||||0.154|TWO_SIDED||||||Regression, Linear|||Comparison of treatment effect of CBT monotherapy vs. combination therapy (reference) on change in EMA fatigue interference NRS score, in complete case linear regression models adjusted for age, sex, anxiety, pain, activity level, study site, and baseline EMA fatigue interference score.||||0.154
72436175|NCT03621761|144385256|SUPERIORITY||Slope|0.034||||0.61|TWO_SIDED||||||Regression, Linear|||Comparison of treatment effect of modafinil monotherapy vs. combination therapy (reference) on change in EMA fatigue interference NRS score, in complete case linear regression models adjusted for age, sex, anxiety, pain, activity level, study site, and baseline EMA fatigue interference score.||||0.610
72436176|NCT03621761|144385257|SUPERIORITY||Slope|0.00427||||0.4955|TWO_SIDED||||||Regression, Linear|||Comparison of treatment effect of CBT monotherapy vs. combination therapy (reference) on change in fatigability score, in complete case linear regression models adjusted for age, sex, anxiety, pain, activity level, study site, and baseline fatigability score.||||0.4955
72436177|NCT03621761|144385257|SUPERIORITY||Slope|-0.00948||||0.1333|TWO_SIDED||||||Regression, Linear|||Comparison of treatment effect of modafinil monotherapy vs. combination therapy (reference) on change in fatigability score, in complete case linear regression models adjusted for age, sex, anxiety, pain, activity level, study site, and baseline fatigability score.||||0.1333
72436178|NCT00855465|144385316|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Prespecified significance level for all significance tests was 5%. Primary analysis, due to result of Shapiro-Wilk test.|Wilcoxon (Mann-Whitney)|Test was stratified by region.||Missing values for participants who withdrew/died before 16 weeks were imputed with a worst value of 0m in case of death/clinical worsening without termination visit and with the last observed value otherwise. Comparison was done using analysis of covariance (ANCOVA), with baseline 6MWD as a covariate and treatment group and region as main effects. The primary statistical method was the stratified Wilcoxon test if the Shapiro-Wilk test for normality of residuals was statistically significant.||||<0.0001
72436179|NCT00855465|144385316|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|45.69|||<|0.0001|TWO_SIDED|95.0|24.74|66.63||Additional analysis, due to result of Shapiro-Wilk test.|ANCOVA|||||66.63|24.74|<0.0001
72558261|NCT02554877|144645932|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|6.96|STANDARD_ERROR_OF_MEAN|2.78||0.0132|TWO_SIDED|90.0|2.36|11.56||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 12.||11.56|2.36|0.0132
72558262|NCT02554877|144645932|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|7.41|STANDARD_ERROR_OF_MEAN|2.75||0.0079|TWO_SIDED|90.0|2.85|11.96||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 12.||11.96|2.85|0.0079
72558263|NCT02554877|144645932|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|10.83|STANDARD_ERROR_OF_MEAN|2.77||0.0001|TWO_SIDED|90.0|6.24|15.42||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 12.||15.42|6.24|0.0001
72558264|NCT02554877|144645933|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|1.46|STANDARD_ERROR_OF_MEAN|3.31||0.6597|TWO_SIDED|90.0|-4.01|6.92||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 2.||6.92|-4.01|0.6597
72436180|NCT00855465|144385316|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0001|||||||Shapiro-Wilk|||Shapiro-Wilk test for normality of ANCOVA residuals.||||0.0001
72436181|NCT00855465|144385317|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Hierarchical testing for secondary efficacy parameters in the order: PVR, NT-proBNP, WHO functional class, Time to clinical worsening, Borg scale, EQ5D, LPH. Primary analysis due to result of Shapiro-Wilk test.|Wilcoxon (Mann-Whitney)|||Missing values at week 16 were imputed using the last available post-baseline observation. Same analysis method as for primary efficacy parameter.||||<0.0001
72436182|NCT00855465|144385317|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-246.43|||<|0.0001|TWO_SIDED|95.0|-303.33|-189.53||Additional analysis due to result of Shapiro-Wilk test.|ANCOVA|||||-189.53|-303.33|<0.0001
72436183|NCT00855465|144385317|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0001|||||||Shapiro-Wilk|||Shapiro-Wilk test for normality of ANCOVA residuals.||||0.0001
72436184|NCT00855465|144385318|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Hierarchical testing for secondary efficacy parameters in the order: PVR, NT-proBNP, WHO functional class, Time to clinical worsening, Borg scale, EQ5D, LPH. Primary analysis due to result of Shapiro-Wilk test.|Wilcoxon (Mann-Whitney)|||Missing values at week 16 were imputed using the last available post-baseline observation. Same analysis method as for primary efficacy parameter.||||<0.0001
72436185|NCT00855465|144385318|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-443.99||||0.0293|TWO_SIDED|95.0|-842.95|-45.03||Additional analysis due to result of Shapiro-Wilk test.|ANCOVA|||||-45.03|-842.95|0.0293
72436186|NCT00855465|144385318|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0001|||||||Shapiro-Wilk|||Shapiro-Wilk test for normality of ANCOVA residuals.||||0.0001
72436187|NCT00855465|144385319|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0026||||||Hierarchical testing for secondary efficacy parameters in the order: PVR, NT-proBNP, WHO functional class, Time to clinical worsening, Borg scale, EQ5D, LPH.|Wilcoxon (Mann-Whitney)|Test was stratified by region.||Missing values for participants who withdrew or died before 16 weeks were imputed with a worst value of IV in case of clinical worsening without termination visit or measurement at that termination visit and with a worst value of V in case of death and with the last observed value otherwise.||||0.0026
72436188|NCT00855465|144385320|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|-3.37||||0.1724|TWO_SIDED|95.0|-8.72|1.99||Hierarchical testing for secondary efficacy parameters in the order: PVR, NT-proBNP, WHO functional class, Time to clinical worsening, Borg scale, EQ5D, LPH.|Log Rank|Test was stratified by region.|Based on Mantel-Haenszel estimate stratified by region.|"Test for difference of occurence of Any event."||1.99|-8.72|0.1724
72436189|NCT00855465|144385321|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0035||||||Hierarchical testing for secondary efficacy parameters in the order: PVR, NT-proBNP, WHO functional class, Time to clinical worsening, Borg scale, EQ5D, LPH. Nominally significant only due to hierarchical testing.|Wilcoxon (Mann-Whitney)|Test was stratified by region.||Missing values for participants who withdrew or died before 16 weeks were imputed with a worst value of 10 in case of death or clinical worsening without termination visit and with the last observed value otherwise.||||0.0035
72436190|NCT00855465|144385322|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Hierarchical testing for secondary efficacy parameters in the order: PVR, NT-proBNP, WHO FC, TTCW, Borg scale, EQ5D, LPH. Primary analysis due to result of Shapiro-Wilk test.Nominally significant only due to hierarchical testing.|Wilcoxon (Mann-Whitney)|||Missing values at baseline were imputed using last available observation prior to start of study treatment. Missing values for participants who withdrew or died before 16 weeks were imputed with a worst value of -0.594 in case of death or clinical worsening without termination visit and with the last observed value otherwise.||||<0.0001
72436191|NCT00855465|144385322|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.13||||0.0002|TWO_SIDED|95.0|0.06|0.21||Additional analysis due to result of Shapiro-Wilk test.|ANCOVA|||||0.21|0.06|0.0002
72436192|NCT00855465|144385322|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0001|||||||Shapiro-Wilk|||Shapiro-Wilk test for normality of ANCOVA residuals.||||0.0001
72558265|NCT02554877|144645933|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|1.02|STANDARD_ERROR_OF_MEAN|3.31||0.7583|TWO_SIDED|90.0|-4.45|6.49||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 2.||6.49|-4.45|0.7583
72558266|NCT02554877|144645933|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|3.11|STANDARD_ERROR_OF_MEAN|3.33||0.3516|TWO_SIDED|90.0|-2.39|8.61||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 2.||8.61|-2.39|0.3516
72558267|NCT02554877|144645933|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|-1.83|STANDARD_ERROR_OF_MEAN|3.38||0.5877|TWO_SIDED|90.0|-7.42|3.75||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 4.||3.75|-7.42|0.5877
72494471|NCT04781816|144518226|SUPERIORITY||Least Square Mean Difference|-5.7|STANDARD_ERROR_OF_MEAN|7.53|||TWO_SIDED|90.0|-18.26|6.85||||||Analysis was performed using mixed model with repeated measurements (MMRM) including fixed effects for baseline CLASI-A, post-baseline visit, geographical region, disease subtype, baseline use of CQ/HCQ, intervention group, visit-by- intervention group interaction, and visit-by-baseline-CLASI-A interaction.||6.85|-18.26|
72494472|NCT01789970|144518246|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.63|||<|0.001|TWO_SIDED|95.0|0.26|1.0||5% significance level|ANCOVA|The model included treatment, study center, opioid status, and baseline WPI score.|Placebo - Hydrocodone ER|The least squares means of the change from baseline to week 12 in WPI were compared between the active drug and placebo treatment groups.||1.00|0.26|<0.001
72494473|NCT01789970|144518247|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.58|||<|0.001|TWO_SIDED|95.0|0.25|0.91||5% significance level|ANCOVA|The model included treatment, study center, opioid status, and baseline WPI score.|Placebo - Hydrocodone ER|The least squares means of the change from baseline to week 12 in API were compared between the active drug and placebo treatment groups.||0.91|0.25|<0.001
72494474|NCT01789970|144518248|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.68||||0.059|TWO_SIDED|95.0|0.5|1.01||5% significance level|Wald chi-square|Cox proportional hazards model with treatment, baseline worst pain intensity (WPI), opioid status, and center in the model||||1.01|0.5|0.059
72494475|NCT01789970|144518249|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.67||||0.0293|TWO_SIDED|95.0|0.47|0.96||5% significance level|Regression, Logistic|stratified by center with the following effects: treatment group, baseline API, and opioid status.|Hydrocodone ER / Placebo|API increase \>=30% and API \>=5||0.96|0.47|0.0293
72494476|NCT01789970|144518250|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.28||||0.557|TWO_SIDED|95.0|-1.2|0.65||5% significance level|ANCOVA|Model with the following effects: treatment, study center, opioid status, and baseline RMDQ score.|Placebo - Hydrocodone ER|||0.65|-1.20|0.557
72494477|NCT02123485|144518267|SUPERIORITY|||||||0.3|||||||Chi-squared|||||||0.30
72494478|NCT03423342|144518270|SUPERIORITY||Mean Difference (Net)|30.2|STANDARD_ERROR_OF_MEAN|3.3|<|0.0001|TWO_SIDED|||||The updated p-value is calculated and not a threshold for statistical significance.|t-test, 2 sided|||||||<0.0001
72494479|NCT03423342|144518271|SUPERIORITY||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|0.0|<|0.05|TWO_SIDED||||||t-test, 2 sided|||||||<0.05
72494480|NCT03423342|144518272|SUPERIORITY||Mean Difference (Net)|19.0|STANDARD_ERROR_OF_MEAN|48.0|<|0.05|TWO_SIDED||||||t-test, 2 sided|||||||<0.05
72494481|NCT03423342|144518273|SUPERIORITY||Mean Difference (Net)|5.0|STANDARD_ERROR_OF_MEAN|17.0|<|0.05|TWO_SIDED||||||t-test, 2 sided|||||||<0.05
72494482|NCT03423342|144518274|SUPERIORITY||Mean Difference (Net)|0.3|STANDARD_ERROR_OF_MEAN|3.1|<|0.05|TWO_SIDED||||||t-test, 2 sided|||||||<0.05
72494483|NCT03423342|144518275|SUPERIORITY||Mean Difference (Net)|0.81|STANDARD_ERROR_OF_MEAN|0.66|<|0.05|TWO_SIDED||||||t-test, 2 sided|||||||<0.05
72494484|NCT03403205|144518294|OTHER||LS Mean Difference|1.64|STANDARD_ERROR_OF_MEAN|0.254|<|0.0001|TWO_SIDED|95.0|1.14|2.13||Test was performed at a significance level of 0.05.|ANCOVA|||Analysis was performed using ANCOVA model, which included treatment, cohort, and baseline value. Missing imputation was performed: 1) for intermediate missing, interpolation was used to fill out missing values. 2) For participants who die, baseline dNCC was carried forward from discontinuation to week 48. 3) For others, multiple imputation was used to impute missing dNCC assuming data were missing not at random.||2.13|1.14|< 0.0001
72494485|NCT03403205|144518294|OTHER||LS Mean Difference|3.79|STANDARD_ERROR_OF_MEAN|0.584|<|0.0001|TWO_SIDED|95.0|2.65|4.94||Test was performed at a significance level of 0.05.|ANCOVA|||Analysis was performed using ANCOVA model, which included treatment, cohort, and baseline value. Missing imputation was performed: 1) for intermediate missing, interpolation was used to fill out missing values. 2) For participants who die, baseline dNCC was carried forward from discontinuation to week 48. 3) For others, multiple imputation was used to impute missing dNCC assuming data were missing not at random.||4.94|2.65|< 0.0001
72494486|NCT03285243|144518306|OTHER|||||||0.001||||||A priori, All p-values \< 0.05 were considered statistically significant.|Chi-squared|||||||0.001
72494487|NCT03285243|144518307|OTHER|||||||0.002||||||a priori, all p-values \< 0.05 were considered statistically significant.|Regression, Logistic|||||||0.002
72494488|NCT01834729|144518308|SUPERIORITY|||||||0.78|||||||Least squares means|||||||0.78
72494489|NCT01834729|144518309|SUPERIORITY|||||||0.57|||||||Least squares means|||||||0.57
72494490|NCT00288080|144518313|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0398|||||||Log Rank|||The study was designed to detect an improvement in the 4-year overall survival rate from 86% (AS+RT) to 93% (AS+RT+CT). Assuming an exponential survival distribution for each arm, then an absolute improvement of 7% in the 4-year overall survival rate translates to a 51% relative reduction (hazard ratio 0.49) in the yearly death rate. Under a 1-sided significance level of 0.05 and 90% power, at least 78 deaths and 486 cases were required to perform the primary endpoint analysis.||||0.0398
72494491|NCT00288080|144518314|SUPERIORITY_OR_OTHER_LEGACY|||||||0.22|||||||Log Rank|||Biochemical control rates at 4 years were calculated using the Kaplan-Meier method and compared by a two-sided log-rank test with a significance level of 0.05.||||0.22
72494492|NCT00288080|144518316|SUPERIORITY_OR_OTHER_LEGACY|||||||0.21|||||||Log Rank|||Distant failure rates at 4 years were calculated using the Kaplan-Meier method and compared by a two-side log-rank test at the 0.05 significance level.||||0.21
72494493|NCT00288080|144518317|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0484|||||||Log Rank|||Disease-free survival rates were compared by a two-sided log-rank test at a significance level of 0.05.||||0.0484
72494494|NCT04925752|144518358|SUPERIORITY||Rate Ratio|0.043|||<|0.0001|TWO_SIDED|95.0|0.01|0.182||p-value for rate ratio vs bHIV is from Wald test.|Wald test||Confidence Interval (CI) for rate ratio vs bHIV is based on the delta method.|Null Hypothesis 01: LEN/bHIV\>= 1; Null hypothesis was to be rejected if HIV-1 incidence in LEN was significantly lower than bHIV.||0.182|0.010|<0.0001
72436193|NCT00855465|144385323|SUPERIORITY_OR_OTHER_LEGACY|||||||0.122||||||Hierarchical testing for secondary efficacy parameters in the order: PVR, NT-proBNP, WHO functional class, Time to clinical worsening, Borg Dyspnea Score, EQ5D, LPH. Primary analysis due to result of Shapiro-Wilk test.|Wilcoxon (Mann-Whitney)|||Missing values at baseline were imputed using last available observation prior to start of study treatment. Missing values for participants who withdrew or died before 16 weeks were imputed with a worst value of 105 in case of death or clinical worsening without termination visit and with the last observed value otherwise.||||0.1220
72436194|NCT00855465|144385323|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.76||||0.0165|TWO_SIDED|95.0|-10.45|-1.06||Additional analysis due to result of Shapiro-Wilk test.|ANCOVA|||||-1.06|-10.45|0.0165
72436195|NCT00855465|144385323|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0001|||||||Shapiro-Wilk|||Shapiro-Wilk test for normality of ANCOVA residuals.||||0.0001
72436196|NCT00855465|144385325|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Exploratory testing. Primary analysis due to result of Shapiro-Wilk test.|Wilcoxon (Mann-Whitney)|||Missing values at week 16 were imputed using the last available post-baseline observation. Same analysis as for primary efficacy parameter.||||<0.0001
72436197|NCT00855465|144385325|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.96|||<|0.0001|TWO_SIDED|95.0|-6.75|-3.16||Additional analysis due to result of Shapiro-Wilk test.|ANCOVA|||||-3.16|-6.75|<0.0001
72436198|NCT00855465|144385325|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0231|||||||Shapiro-Wilk|||Shapiro-Wilk test for normality of ANCOVA residuals.||||0.0231
72436199|NCT00855465|144385326|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.47|||<|0.0001|TWO_SIDED|95.0|0.33|0.62||Exploratory testing. Primary analysis due to result of Shapiro-Wilk test.|ANCOVA|||Missing values at week 16 were imputed using the last available post-baseline observation. Same analysis as for primary efficacy parameter.||0.62|0.33|<0.0001
72436200|NCT00855465|144385326|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Additional analysis due to result of Shapiro-Wilk test.|Wilcoxon (Mann-Whitney)|||||||<0.0001
72436201|NCT00855465|144385326|SUPERIORITY_OR_OTHER_LEGACY|||||||0.116|||||||Shapiro-Wilk|||Shapiro-Wilk test for normality of ANCOVA residuals.||||0.1160
72494495|NCT04925752|144518358|SUPERIORITY||Rate Ratio|0.043|||<|0.0001|TWO_SIDED|95.0|0.01|0.182||p-value for rate ratio vs bHIV is from Wald test.|Wald test||CI for rate ratio vs bHIV is based on the delta method.|Null Hypothesis 02: LEN/bHIV\>= 0.8; Null hypothesis was to be rejected if HIV-1 incidence in LEN was significantly and at least 20% lower than bHIV.||0.182|0.010|< 0.0001
72436202|NCT04365400|144385367|SUPERIORITY||Hodges Lehmann Median|8.24||||0.1148124|TWO_SIDED|95.0|-2.01|18.19|||Wilcoxon (Mann-Whitney)|||||18.19|-2.01|0.1148124
72436203|NCT04365400|144385367|SUPERIORITY||Hodges Lehmann Median|-0.82||||0.8668467|TWO_SIDED|95.0|-10.16|7.96|||Wilcoxon (Mann-Whitney)|||||7.96|-10.16|0.8668467
72436204|NCT04365400|144385368|SUPERIORITY||Difference in Change in HbA1c (%)|0.02516||||0.8658|TWO_SIDED|95.0|-0.26658|0.316897|||ANCOVA|||||0.316897|-0.26658|0.8658
72436205|NCT04365400|144385368|SUPERIORITY||Difference in Change in HbA1c (%)|-0.07333||||0.65|TWO_SIDED|95.0|-0.39012|0.243455|||ANCOVA|||||0.243455|-0.39012|0.6500
72436206|NCT04567888|144385371|SUPERIORITY||Slope|-1.41|||<|0.001|TWO_SIDED|95.0|-1.88|-0.95||Threshold for statistical significance set to .050.|Repeated-measures Multilevel Models|||||-0.95|-1.88|<.001
72436207|NCT04567888|144385372|SUPERIORITY||Slope|-0.54|||<|0.001|TWO_SIDED|95.0|-0.78|-0.3||Threshold for statistical significance was set to .050.|Repeated-measures Multilevel Models|||||-0.30|-0.78|< .001
72436208|NCT01490580|144385385|SUPERIORITY||Risk Difference (RD)|-6.4||||0.38|TWO_SIDED|95.0|-21.0|8.1|||Mixed Models Analysis|||||8.1|-21.0|0.38
72436209|NCT01544062|144385412|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.7||||0.024|TWO_SIDED|95.0|2.3|31.1|||t-test, 2 sided|||||31.1|2.3|0.024
72436210|NCT01544062|144385412|SUPERIORITY_OR_OTHER|||||||0.013|TWO_SIDED|||||controlling for age, sex and body mass index|ANCOVA|||||||0.013
72436211|NCT01544062|144385413|SUPERIORITY_OR_OTHER|||||||0.059|TWO_SIDED||||||t-test, 2 sided|||||||0.059
72436212|NCT01544062|144385413|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED|||||controlling for age, sex and body mass index|ANCOVA|||||||0.020
72436213|NCT01544062|144385414|SUPERIORITY_OR_OTHER|||||||0.724|TWO_SIDED||||||t-test, 2 sided|||||||0.724
72436214|NCT01544062|144385414|SUPERIORITY_OR_OTHER|||||||0.51|TWO_SIDED|||||controlling for age, sex and body mass index|ANCOVA|||||||0.510
72436215|NCT01544062|144385415|SUPERIORITY_OR_OTHER|||||||0.397|TWO_SIDED||||||t-test, 2 sided|||||||0.397
72436216|NCT01544062|144385415|SUPERIORITY_OR_OTHER|||||||0.458|TWO_SIDED|||||controlling for age, sex and body mass index|ANCOVA|||||||0.458
72436217|NCT01544062|144385416|SUPERIORITY_OR_OTHER|||||||0.6|TWO_SIDED||||||t-test, 2 sided|||||||0.600
72436218|NCT01544062|144385416|SUPERIORITY_OR_OTHER|||||||0.509|TWO_SIDED||||||ANCOVA|controlling for age, sex and body mass index||||||0.509
72436219|NCT01544062|144385417|SUPERIORITY_OR_OTHER|||||||0.399|TWO_SIDED||||||t-test, 2 sided|||||||0.399
72436220|NCT01544062|144385417|SUPERIORITY_OR_OTHER|||||||0.395|TWO_SIDED|||||controlling for age, sex and body mass index|ANCOVA|||||||0.395
72436221|NCT01544062|144385418|SUPERIORITY_OR_OTHER|||||||0.771|TWO_SIDED||||||t-test, 2 sided|||||||0.771
72436222|NCT01544062|144385418|SUPERIORITY_OR_OTHER|||||||0.927|TWO_SIDED|||||controlling for age, sex and body mass index|ANCOVA|||||||0.927
72436223|NCT01544062|144385419|SUPERIORITY_OR_OTHER|||||||0.644|TWO_SIDED||||||t-test, 2 sided|||||||0.644
72436224|NCT01544062|144385419|SUPERIORITY_OR_OTHER|||||||0.16|TWO_SIDED|||||controlling for age, sex and body mass index|ANCOVA|||||||0.160
72436225|NCT01544062|144385420|SUPERIORITY_OR_OTHER|||||||0.71|TWO_SIDED||||||t-test, 2 sided|||||||0.710
72436226|NCT01544062|144385420|SUPERIORITY_OR_OTHER|||||||0.475|TWO_SIDED|||||controlling for age, sex and body mass index|ANCOVA|||||||0.475
72436227|NCT01544062|144385421|SUPERIORITY_OR_OTHER|||||||0.508|TWO_SIDED||||||t-test, 2 sided|||||||0.508
72436228|NCT01544062|144385421|SUPERIORITY_OR_OTHER|||||||0.905|TWO_SIDED|||||controlling for age, sex and body mass index|ANCOVA|||||||0.905
72436229|NCT01544062|144385422|SUPERIORITY_OR_OTHER|||||||0.104|TWO_SIDED||||||t-test, 2 sided|||||||0.104
72436230|NCT01544062|144385423|SUPERIORITY_OR_OTHER|||||||0.58|TWO_SIDED||||||Fisher Exact|||||||0.580
72436231|NCT01544062|144385424|SUPERIORITY_OR_OTHER|||||||0.619|TWO_SIDED||||||Fisher Exact|||||||0.619
72618754|NCT01026038|144768109|SUPERIORITY_OR_OTHER||GMT ratio|1.0|||||TWO_SIDED|95.0|0.74|1.28||||||Serotype 19A: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||1.28|0.74|
72494496|NCT04925752|144518359|OTHER|Null Hypothesis 03: LEN - F/TDF\>= 0.8/100PY; Null hypothesis was to be rejected if HIV-1 incidence in LEN is not substantially greater than F/TDF (LEN is comparable to F/TDF).|Rate difference|-0.828|||<|0.0001|TWO_SIDED|95.0|-1.669|-0.255||p-value for rate difference (SC LEN minus F/TDF) is based on a hybrid approach.|Hybrid approach||Exact CI for rate difference versus F/TDF is based on a hybrid approach.|||-0.255|-1.669|<0.0001
72436232|NCT01544062|144385425|SUPERIORITY_OR_OTHER|||||||0.511|TWO_SIDED||||||Fisher Exact|||||||0.511
72436233|NCT01544062|144385426|SUPERIORITY_OR_OTHER|||||||0.501|TWO_SIDED||||||Fisher Exact|||||||0.501
72436234|NCT01544062|144385427|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Fisher Exact|||||||1.000
72436235|NCT01544062|144385428|SUPERIORITY_OR_OTHER|||||||0.299|TWO_SIDED||||||Fisher Exact|||||||0.299
72436236|NCT01544062|144385429|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Fisher Exact|||||||1.000
72436237|NCT01544062|144385430|SUPERIORITY_OR_OTHER|||||||0.492|TWO_SIDED||||||Fisher Exact|||||||0.492
72436238|NCT01544062|144385431|SUPERIORITY_OR_OTHER|||||||0.455|TWO_SIDED||||||Fisher Exact|||||||0.455
72436239|NCT01544062|144385432|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Fisher Exact|||||||1.000
72436240|NCT00392678|144385433|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0|||||Mixed Models Analysis|||||||<0.05
72436241|NCT05012644|144385440|OTHER||Odds Ratio (OR)|1.266|||||TWO_SIDED|95.0|0.715|2.241||||||||2.241|0.715|
72436242|NCT05012644|144385441|OTHER||Odds Ratio (OR)|1.508|||||TWO_SIDED|95.0|0.819|2.774||||||||2.774|0.819|
72494497|NCT04925752|144518359|SUPERIORITY||Rate Ratio|0.111||||0.00245|TWO_SIDED|95.0|0.024|0.513||P-value for rate ratio versus F/TDF is from a Poisson model.|Poisson model||Confidence interval for rate ratio versus F/TDF is from a Poisson model.|Null Hypothesis 04: LEN vs F/TDF\>= 1; Null hypothesis was to be rejected if HIV-1 incidence in LEN was significantly lower than F/TDF.||0.513|0.024|0.00245
72618755|NCT01026038|144768109|SUPERIORITY_OR_OTHER||GMT ratio|0.8|||||TWO_SIDED|95.0|0.59|1.02||||||Serotype 19A: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.02|0.59|
72436243|NCT03425643|144385450|SUPERIORITY||Hazard Ratio (HR)|0.59|||<|1e-05|TWO_SIDED|95.0|0.48|0.72||One-sided p-value based on log-rank test stratified by Stage (II versus III), TPS (\>=50% versus \<50%), Histology (Squamous versus Non-squamous) and Region (East-Asia versus non-East Asia).|Log Rank||Stratified Cox model with Efron's tie handling method with treatment as a covariate stratified by Stage (II versus III), TPS (\>=50% versus \<50%), Histology (Squamous versus Non-squamous) and Region (East-Asia versus non-East Asia).|||0.72|0.48|<0.00001
72436244|NCT03425643|144385451|SUPERIORITY||Hazard Ratio (HR)|0.72||||0.00517|TWO_SIDED|95.0|0.56|0.93||One-sided p-value based on log-rank test stratified by Stage (II versus III), TPS (\>=50% versus \<50%), Histology (Squamous versus Non-squamous) and Region (East-Asia versus non-East Asia).|Log Rank||Stratified Cox model with Efron's tie handling method with treatment as a covariate stratified by Stage (II versus III), TPS (\>=50% versus \<50%), Histology (Squamous versus Non-squamous) and Region (East-Asia versus non-East Asia).|||0.93|0.56|0.00517
72436245|NCT03425643|144385452|OTHER|Based on Miettinen \& Nurminen method stratified by Stage (II versus III), TPS (\>=50% versus \<50%), Histology (Squamous versus Non-squamous) and Region (East-Asia versus non-East Asia).|Difference in Percentage|19.2|||<|1e-05|TWO_SIDED|95.0|13.9|24.7|||Stratified Miettinen and Nurminen|||||24.7|13.9|<0.00001
72436246|NCT03425643|144385453|OTHER|Based on Miettinen \& Nurminen method stratified by Stage (II versus III), TPS (\>=50% versus \<50%), Histology (Squamous versus Non-squamous) and Region (East-Asia versus non-East Asia).|Difference in Pertentage|14.2|||<|1e-05|TWO_SIDED|95.0|10.1|18.7|||Stratified Miettinen and Nurminen|||||18.7|10.1|<0.00001
72436247|NCT03425643|144385454|OTHER|Based on a constrained longitudinal data analysis (cLDA) model with the scores as the response variable with covariates for treatment by visit interaction and stratification factors (Stage (II versus III), TPS (\>=50% versus \<50%), Histology (Squamous versus Non-squamous) and Region (East-Asia versus non-East Asia).|Difference in Least Square Means|1.43||||0.3611|TWO_SIDED|95.0|-1.64|4.49|||t-test, 2 sided|||||4.49|-1.64|0.3611
72436248|NCT03425643|144385455|OTHER|Based on a constrained longitudinal data analysis (cLDA) model with the scores as the response variable with covariates for treatment by visit interaction and stratification factors (Stage (II versus III), TPS (\>=50% versus \<50%), Histology (Squamous versus Non-squamous) and Region (East-Asia versus non-East Asia).|Difference in Least Square Means|2.22||||0.1197|TWO_SIDED|95.0|-0.58|5.02|||t-test, 2 sided|||||5.02|-0.58|0.1197
72436249|NCT02628093|144385480|OTHER|Because this was a pilot (exploratory) randomized study, no formal sample size calculation was required.||||||0.214||||||P value threshold \<0.05|Wilcoxon (Mann-Whitney)|||Because this was a pilot (exploratory) randomized study, no formal sample size calculation was required. Demographic, preoperative, and postoperative variables and the primary outcome were compared between groups (THUNDERBEAT and LigaSure) by the Wilcoxon rank-sum test for continuous variables and the chi-square test/Fisher's exact test for categorical variables, as appropriate. All p-values are two-sided with statistical significance evaluated at the 0.05 alpha level.||||0.214
72436250|NCT02628093|144385481|OTHER|||||||0.007||||||P value threshold \<0.05|Wilcoxon (Mann-Whitney)|||compared between groups by the Wilcoxon rank-sum test||||0.007
72436251|NCT02628093|144385485|OTHER|||||||1||||||P value threshold \<0.05|Fisher Exact|||||||1.0
72436252|NCT02525796|144385498|SUPERIORITY||Median Difference (Net)|3.2||||0.84|TWO_SIDED||||||ANOVA|||ANOVA comparing the change in PTH over 4 weeks between eplerenone monotherapy and placebo||||0.84
72494498|NCT00546052|144518369|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.02|STANDARD_DEVIATION|0.74||0.999||95.0|-0.02|0.06|||t-test, 1 sided|||Single Cohort Study. Statistical Analysis is based on change from baseline. Null hypothesis value is + 0.5%.||0.06|-0.02|0.999
72494499|NCT00546052|144518370|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.04|STANDARD_DEVIATION|0.62||0.999||95.0|0.01|0.07|||t-test, 1 sided|||Single Cohort Study. Statistical Analysis is based on change from baseline. Null hypothesis value is + 0.5mmol/L.||0.07|0.01|0.999
72618756|NCT01026038|144768109|SUPERIORITY_OR_OTHER||GMT ratio|0.8|||||TWO_SIDED|95.0|0.58|1.1||||||Serotype 19A: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.10|0.58|
72558268|NCT02554877|144645933|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|-4.33|STANDARD_ERROR_OF_MEAN|3.38||0.2016|TWO_SIDED|90.0|-9.92|1.26||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 4.||1.26|-9.92|0.2016
72558269|NCT02554877|144645933|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|-6.49|STANDARD_ERROR_OF_MEAN|3.39||0.0568|TWO_SIDED|90.0|-12.08|-0.89||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 4.||-0.89|-12.08|0.0568
72558270|NCT02554877|144645933|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|-2.94|STANDARD_ERROR_OF_MEAN|3.36||0.3827|TWO_SIDED|90.0|-8.48|2.61||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 8.||2.61|-8.48|0.3827
72558271|NCT02554877|144645933|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|-5.31|STANDARD_ERROR_OF_MEAN|3.33||0.1126|TWO_SIDED|90.0|-10.81|0.2||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 8.||0.20|-10.81|0.1126
72558272|NCT02554877|144645933|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|-4.17|STANDARD_ERROR_OF_MEAN|3.36||0.216|TWO_SIDED|90.0|-9.73|1.38||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 8.||1.38|-9.73|0.2160
72558273|NCT02554877|144645933|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|3.54|STANDARD_ERROR_OF_MEAN|3.74||0.3443|TWO_SIDED|90.0|-2.64|9.72||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 12.||9.72|-2.64|0.3443
72494500|NCT00546052|144518372|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-16.95|STANDARD_DEVIATION|13.34|<|0.001||95.0|-17.62|-16.27|||t-test, 2 sided|||Single Cohort Study. Statistical Analysis is based on change from baseline. Null hypothesis value is 0 mm Hg||-16.27|-17.62|<0.001
72494501|NCT00546052|144518373|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-9.84|STANDARD_DEVIATION|8.39|<|0.001||95.0|-10.29|-9.39|||t-test, 2 sided|||Single Cohort Study. Statistical Analysis is based on change from baseline. Null hypothesis value is 0 mm Hg.||-9.39|-10.29|<0.001
72494502|NCT00546052|144518374|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.3|STANDARD_DEVIATION|5.4|<|0.001|||||||t-test, 2 sided|||Single Cohort Study. Statistical Analysis is based on change from baseline. Null Hypothesis value is 0.||||<0.001
72494503|NCT00546052|144518375|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-7.3|STANDARD_DEVIATION|5.2|<|0.001|||||||t-test, 2 sided|||Single Cohort Study. Statistical Analysis is based on change from baseline. Null Hypothesis value is 0.||||<0.001
72494504|NCT00546052|144518376|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-1.5|STANDARD_DEVIATION|32.1||0.084|||||||t-test, 2 sided|||Single Cohort Study. Statistical Analysis is based on change from baseline. Null Hypothesis value is 0.||||0.084
72494505|NCT00546052|144518377|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.2|STANDARD_DEVIATION|18.0||0.654|||||||t-test, 2 sided|||Single Cohort Study. Statistical Analysis is based on change from baseline. Null Hypothesis value is 0.||||0.654
72494506|NCT00546052|144518378|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.1|STANDARD_DEVIATION|43.5||0.336|||||||t-test, 2 sided|||Single Cohort Study. Statistical Analysis is based on change from baseline. Null Hypothesis value is 0.||||0.336
72494507|NCT00546052|144518379|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.0|STANDARD_DEVIATION|17.0||0.001|||||||t-test, 2 sided|||Single Cohort Study. Statistical Analysis is based on change from baseline. Null Hypothesis value is 0.||||0.001
72494508|NCT00546052|144518380|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-19.2|STANDARD_DEVIATION|63.8||0.001|||||||t-test, 2 sided|||Single Cohort Study. Statistical Analysis is based on change from baseline. Null Hypothesis value is 0.||||0.001
72494509|NCT00546052|144518381|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.4|STANDARD_DEVIATION|8.7||0.613|||||||t-test, 2 sided|||Single Cohort Study. Statistical Analysis is based on change from baseline. Null Hypothesis value is 0.||||0.613
72494510|NCT01680900|144518382|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.06||||0.05|TWO_SIDED|95.0|-2.6|-0.48|||Regression, Linear|||||-0.48|-2.60|0.05
72494511|NCT01680900|144518383|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Chi-squared|||||||<0.05
72494512|NCT01680900|144518384|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.19|||<|0.05|TWO_SIDED|95.0|-0.75|-0.08|||Regression, Linear|||||-0.08|-0.75|<0.05
72494513|NCT01680900|144518388|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.22||||0.05|TWO_SIDED|95.0|-0.74|-0.21|||Regression, Linear|||||-0.21|-0.74|0.05
72494514|NCT01928381|144518389|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.13|STANDARD_ERROR_OF_MEAN|0.23||0.5695|TWO_SIDED|95.0|-0.34|0.61|||Mixed Models Analysis|||||0.61|-0.34|0.5695
72494515|NCT01928381|144518389|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.03|STANDARD_ERROR_OF_MEAN|0.23||0.8905|TWO_SIDED|95.0|-0.43|0.49|||Mixed Models Analysis|||||0.49|-0.43|0.8905
72494516|NCT01928381|144518389|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.17|STANDARD_ERROR_OF_MEAN|0.23||0.4822|TWO_SIDED|95.0|-0.3|0.64|||Mixed Models Analysis|||||0.64|-0.30|0.4822
72494517|NCT01928381|144518390|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.31|STANDARD_ERROR_OF_MEAN|0.25||0.2237|TWO_SIDED|95.0|-0.2|0.82|||Mixed Models Analysis||In direction of Pregabalin|||0.82|-0.20|0.2237
72494518|NCT01928381|144518390|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.42|STANDARD_ERROR_OF_MEAN|0.25||0.0978|TWO_SIDED|95.0|-0.93|0.08|||Mixed Models Analysis||In direction of Pregabain, positive control|||0.08|-0.93|0.0978
72494519|NCT01928381|144518390|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.11|STANDARD_ERROR_OF_MEAN|0.25||0.661|TWO_SIDED|95.0|-0.62|0.4|||Mixed Models Analysis|||||0.40|-0.62|0.6610
72436253|NCT02525796|144385498|SUPERIORITY||Median Difference (Net)|4.5||||0.54|TWO_SIDED||||||ANOVA|||ANOVA comparing the change in PTH over 4 weeks between amiloride monotherapy and placebo||||0.54
72436254|NCT02525796|144385498|SUPERIORITY||Median Difference (Net)|7.6||||0.58|TWO_SIDED||||||ANOVA|||ANOVA comparing the change in PTH over 4 weeks between eplerenone monotherapy and amiloride monotherapy||||0.58
72436255|NCT02525796|144385499|SUPERIORITY||Median Difference (Net)|0.0||||0.82|TWO_SIDED||||||ANOVA|||ANOVA comparing the change in serum calcium over 4 weeks between eplerenone monotherapy and placebo||||0.82
72436256|NCT02525796|144385499|SUPERIORITY||Median Difference (Net)|0.1||||0.21|TWO_SIDED||||||ANOVA|||ANOVA comparing the change in serum calcium over 4 weeks between amiloride monotherapy and placebo||||0.21
72436257|NCT02525796|144385499|SUPERIORITY||Median Difference (Net)|0.1||||0.12|TWO_SIDED||||||ANOVA|||ANOVA comparing the change in serum calcium over 4 weeks between eplerenone monotherapy and amiloride monotherapy||||0.12
72436258|NCT00970307|144385520|NON_INFERIORITY|Criterion for evaluation of Non-inferiority: the upper limit of Standardised asymptotic 95% confidence interval lower or equal to 10% .|Difference in percentage|-0.76|||||TWO_SIDED|95.0|-4.21|2.22||||||||2.22|-4.21|
72436259|NCT00970307|144385521|NON_INFERIORITY|Criterion for evaluation of Non-inferiority: the upper limit of Standardized asymptotic 95% confidence interval lower or equal to 10% .|Difference in percentage|-0.72|||||TWO_SIDED|95.0|-5.19|3.57||||||||3.57|-5.19|
72436260|NCT00355914|144385558|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|95.0||||Results were considered statistically significant if the P value was less than 0.05.|t-test, 2 sided|||compared baseline, 3, 6, 12, 18, and 24 months between groups||||>0.05
72436261|NCT00355914|144385559|SUPERIORITY_OR_OTHER||||||>|0.05||95.0||||Results were considered statistically significant if the P value was less than 0.05.|t-test, 2 sided|||baseline, 3, 6, 12, 18, and 24 months between groups||||>0.05
72494520|NCT04770753|144518414|SUPERIORITY||Percentage difference|40.9|||<|0.0001|TWO_SIDED|95.0|32.0|49.8|||Cochran-Mantel-Haenszel|||The estimated adjusted difference in response rate, 95% CI, and p-value are based on Mantel-Haenszel stratum weighted method adjusting for the randomization stratification factors.||49.8|32.0|<0.0001
72494521|NCT04770753|144518415|SUPERIORITY||Difference in Lean Square (LS) Mean|3.4||||0.0026|TWO_SIDED|95.0|1.21|5.59|||ANCOVA|||The estimates, 95% CIs, and 2-sided p-value are based on an analysis of covariance (ANCOVA) model which includes average change from baseline in FACIT-Fatigue subscale score from Week 12 through Week 24 as the dependent variable, treatment group as the independent variable, and baseline and the randomization stratification factors as covariates.||5.59|1.21|0.0026
72494522|NCT04770753|144518416|SUPERIORITY||Difference in LS Mean|9.63|||<|0.0001|TWO_SIDED|95.0|7.8|11.46|||ANCOVA|||The estimates, 95% CIs, and 2-sided p-value are based on an ANCOVA model which includes average change from baseline in Hb concentrations from Week 12 through Week 24 as the dependent variable, treatment group as the independent variable, and baseline Hb concentration and the randomization stratification factors as covariates.||11.46|7.80|<0.0001
72494523|NCT02775851|144518438|SUPERIORITY||||||<|0.001|||||||One-sided Exact Binomial|||We assumed a null pCR rate of 5% and powered the study assuming an alternative hypothesis of 25%. This single stage design had an alpha of 3.4% (i.e. probability of declaring the regimen warrants further study when the true CR is 5%) and a power of 90% (probability of declaring the regimen warrants further study when the true pCR is 25%) with 25 eligible participants.||||<0.001
72558274|NCT02554877|144645933|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|3.82|STANDARD_ERROR_OF_MEAN|3.7||0.3031|TWO_SIDED|90.0|-2.3|9.94||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 12.||9.94|-2.30|0.3031
72558275|NCT02554877|144645933|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|0.88|STANDARD_ERROR_OF_MEAN|3.72||0.8129|TWO_SIDED|90.0|-5.27|7.04||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 12.||7.04|-5.27|0.8129
72558276|NCT02554877|144645934|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|0.34|STANDARD_ERROR_OF_MEAN|0.4||0.402|TWO_SIDED|90.0|-0.33|1.01||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 2.||1.01|-0.33|0.4020
72436262|NCT05372094|144385608|OTHER|||||||0.007|||||||Mixed Models Analysis|||Fixed factor of program and random intercept of participant||||0.007
72436263|NCT05372094|144385608|OTHER||||||<|0.05|||||||Mixed Models Analysis|||Follow up comparison between noise reduction setting OFF and noise reduction setting STRONG||||< 0.05
72436264|NCT05372094|144385608|OTHER||||||<|0.01|||||||Mixed Models Analysis|||Follow up comparison between noise reduction setting STRONG and noise reduction setting WEAK||||<0.01
72436265|NCT05372094|144385608|OTHER||||||>|0.05|||||||Mixed Models Analysis|||"Follow up comparison between ratings of effort with OFF and WEAK"||||>.05
72436266|NCT05372094|144385609|OTHER|||||||0.283|||||||Mixed Models Analysis|||||||0.283
72436267|NCT05372094|144385610|OTHER|||||||0.145|||||||Mixed Models Analysis|||Analysis was done only between NR OFF and NR at a custom or preferred setting.||||0.145
72436268|NCT05372094|144385611|OTHER|||||||0.3018|||||||Exact Binomial test|||An exact binomial test was performed to evaluate if the majority of teens and pre-teens with mild to severe hearing loss preferred NR setting (i.e., either weak or strong) to the NR setting OFF.||||0.3018
72436269|NCT05372094|144385612|OTHER|||||||0.1796|||||||Exact Binomial test|||Exact binomial test was done to evaluate if the majority (\>50%) of teens and pre-teens prefer to use Tap Control to access Bluetooth streaming, compared to using the HA push button or phone controls.||||0.1796
72436270|NCT01193153|144385630|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.49|||<|0.001|TWO_SIDED|95.0|1.55|3.99|||Log Rank|||All participants: p-value was calculated using log-rank test.||3.99|1.55|<0.001
72436271|NCT01193153|144385630|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|3.38||||0.002|TWO_SIDED|95.0|1.57|7.28|||Regression, Cox|||Monotherapy subset: Hazard ratio and corresponding p-value, and 95% Confidence Interval (CI) were calculated from Cox proportional hazard regression model.||7.28|1.57|0.002
72384132|NCT01675427|144276012|SUPERIORITY_OR_OTHER|||||||0.0114|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three ITPA genotype categories|Cochran-Armitage Trend Test|||G3||||0.0114
72384133|NCT01675427|144276012|SUPERIORITY_OR_OTHER|||||||0.2293|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three ITPA genotype categories|Cochran-Armitage Trend Test|||G4||||0.2293
72384134|NCT01675427|144276012|SUPERIORITY_OR_OTHER|||||||0.2857|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three ITPA genotype categories|Cochran-Armitage Trend Test|||Other genotypes||||0.2857
72384135|NCT01675427|144276012|SUPERIORITY_OR_OTHER|||||||0.0001|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three ITPA genotype categories|Cochran-Armitage Trend Test|||Total genotypes||||0.0001
72384136|NCT01675427|144276013|SUPERIORITY_OR_OTHER|||||||0.0081|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three ITPA genotype categories|Cochran-Armitage Trend Test|||G1||||0.0081
72384137|NCT01675427|144276013|SUPERIORITY_OR_OTHER|||||||0.0563|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three ITPA genotype categories|Cochran-Armitage Trend Test|||G2||||0.0563
72384138|NCT01675427|144276013|SUPERIORITY_OR_OTHER|||||||0.3516|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three ITPA genotype categories|Cochran-Armitage Trend Test|||G3||||0.3516
72384139|NCT01675427|144276013|SUPERIORITY_OR_OTHER|||||||0.0064|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three ITPA genotype categories|Cochran-Armitage Trend Test|||G4||||0.0064
72384140|NCT01675427|144276013|SUPERIORITY_OR_OTHER|||||||0.2707|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three ITPA genotype categories|Cochran-Armitage Trend Test|||Other genotypes||||0.2707
72384141|NCT01675427|144276013|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three ITPA genotype categories|Cochran-Armitage Trend Test|||Total genotypes||||< 0.0001
72384142|NCT01675427|144276014|SUPERIORITY_OR_OTHER|||||||0.0634|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three ITPA genotype categories|Cochran-Armitage Trend Test|||G1||||0.0634
72384143|NCT01675427|144276014|SUPERIORITY_OR_OTHER|||||||0.7176|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three ITPA genotype categories|Cochran-Armitage Trend Test|||G2||||0.7176
72384144|NCT01675427|144276014|SUPERIORITY_OR_OTHER|||||||0.3944|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three ITPA genotype categories|Cochran-Armitage Trend Test|||G3||||0.3944
72384145|NCT01675427|144276014|SUPERIORITY_OR_OTHER|||||||0.861|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three ITPA genotype categories|Cochran-Armitage Trend Test|||G4||||0.8610
72384146|NCT01675427|144276014|SUPERIORITY_OR_OTHER|||||||0.4543|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three ITPA genotype categories|Cochran-Armitage Trend Test|||Other genotypes||||0.4543
72384147|NCT01675427|144276014|SUPERIORITY_OR_OTHER|||||||0.0406|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three ITPA genotype categories|Cochran-Armitage Trend Test|||Total genotypes||||0.0406
72558277|NCT02554877|144645934|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|0.06|STANDARD_ERROR_OF_MEAN|0.4||0.8789|TWO_SIDED|90.0|-0.61|0.73||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 2.||0.73|-0.61|0.8789
72384148|NCT01675427|144276015|SUPERIORITY_OR_OTHER|||||||0.8234|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three ITPA genotype categories|Cochran-Armitage Trend Test|||G1||||0.8234
72384149|NCT01675427|144276015|SUPERIORITY_OR_OTHER|||||||0.2427|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three ITPA genotype categories|Cochran-Armitage Trend Test|||G2||||0.2427
72384150|NCT01675427|144276015|SUPERIORITY_OR_OTHER|||||||0.4805|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three ITPA genotype categories|Cochran-Armitage Trend Test|||G3||||0.4805
72384151|NCT01675427|144276015|SUPERIORITY_OR_OTHER|||||||0.2901|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three ITPA genotype categories|Cochran-Armitage Trend Test|||G4||||0.2901
72384152|NCT01675427|144276015|SUPERIORITY_OR_OTHER|||||||0.3927|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three ITPA genotype categories|Cochran-Armitage Trend Test|||Other genotypes||||0.3927
72384153|NCT01675427|144276015|SUPERIORITY_OR_OTHER|||||||0.5769|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three ITPA genotype categories|Cochran-Armitage Trend Test|||Total genotypes||||0.5769
72384154|NCT00700570|144276018|SUPERIORITY_OR_OTHER|||||||0.1341|TWO_SIDED||||||Log Rank|||||||0.1341
72384155|NCT00700570|144276020|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED||||||Fisher Exact|||||||0.0010
72384156|NCT01461980|144276059|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority criteria margin was 1.5-fold and statistical inference was based on the CIs of the GMC ratios. Non-inferiority was achieved when the lower limit of the 2-sided 95% CI for the GMC ratios after vaccination 1 was greater than 0.67.|GMC Ratio|0.94|||||TWO_SIDED|95.0|0.86|1.03||||||Diphtheria: CIs for GMC ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (Group 1 - Group 2 for Diphtheria antigens).||1.03|0.86|
72436272|NCT01193153|144385630|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.03||||0.021|TWO_SIDED|95.0|1.11|3.68|||Regression, Cox|||Adjunct therapy subset: Hazard ratio and corresponding p-value, and 95% CI were calculated from Cox proportional hazard regression model.||3.68|1.11|0.021
72436273|NCT01193153|144385630|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.82|||<|0.001|TWO_SIDED|95.0|1.7|4.67|||Regression, Cox|||Psychotic Symptoms: Hazard ratio and corresponding p-value, and 95% CI were calculated from Cox proportional hazard regression model.||4.67|1.70|<0.001
72436274|NCT01193153|144385630|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.93|||<|0.001|TWO_SIDED|95.0|1.7|5.04|||Regression, Cox|||Mood Symptoms (Any Mood Symptoms):Hazard ratio and corresponding p-value, and 95% CI were calculated from Cox proportional hazard regression model.||5.04|1.70|<0.001
72558278|NCT02554877|144645934|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|0.87|STANDARD_ERROR_OF_MEAN|0.41||0.0345|TWO_SIDED|90.0|0.19|1.54||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 2.||1.54|0.19|0.0345
72436275|NCT01193153|144385630|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|3.62||||0.012|TWO_SIDED|95.0|1.32|9.89|||Regression, Cox|||Mood Symptoms (Manic): Hazard ratio and corresponding p-value, and 95% CI were calculated from Cox proportional hazard regression model.||9.89|1.32|0.012
72436276|NCT01193153|144385630|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|3.12||||0.006|TWO_SIDED|95.0|1.39|6.98|||Regression, Cox|||Mood Symptoms (Depressive): Hazard ratio and corresponding p-value, and 95% CI were calculated from Cox proportional hazard regression model.||6.98|1.39|0.006
72436277|NCT01193153|144385630|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.93||||0.238|TWO_SIDED|95.0|0.65|5.78|||Regression, Cox|||Mood Symptoms (Mixed): Hazard ratio and corresponding p-value, and 95% CI were calculated from Cox proportional hazard regression model.||5.78|0.65|0.238
72494524|NCT02775851|144518439|SUPERIORITY||||||<|0.001|||||||One-sided Exact Binomial|||We assumed a null CR rate of 5% and powered the study assuming an alternative hypothesis of 20%. This single stage design had an alpha of 8.5% (i.e. probability of declaring the regimen warrants further study when the true CR is 5%) and a power of 82% (probability of declaring the regimen warrants further study when the true CR is 20%) with 21 eligible participants.||||<0.001
72558279|NCT02554877|144645934|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|1.28|STANDARD_ERROR_OF_MEAN|0.48||0.0087|TWO_SIDED|90.0|0.48|2.08||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 4.||2.08|0.48|0.0087
72384157|NCT01461980|144276059|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority criteria margin was 1.5-fold and statistical inference was based on the CIs of the GMC ratios. Non-inferiority was achieved when the lower limit of the 2-sided 95% CI for the GMC ratios after vaccination 1 was greater than 0.67.|GMC Ratio|0.92|||||TWO_SIDED|95.0|0.85|0.99||||||Tetanus: CIs for GMC ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (Group 1 - Group 2 for Tetanus antigens).||0.99|0.85|
72384158|NCT01461980|144276060|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority criteria margin was 1.5-fold and statistical inference was based on the CIs of the GMC ratios. Non-inferiority was achieved when the lower limit of the 2-sided 95% CI for the GMC ratios after vaccination 1 was greater than 0.67.|GMC Ratio|0.93|||||TWO_SIDED|95.0|0.85|1.02||||||Pertussis toxoid: CIs for GMC ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (Group 1 - Group 2 for Pertussis toxoid).||1.02|0.85|
72384159|NCT01461980|144276060|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority criteria margin was 1.5-fold and statistical inference was based on the CIs of the GMC ratios. Non-inferiority was achieved when the lower limit of the 2-sided 95% CI for the GMC ratios after vaccination 1 was greater than 0.67.|GMC Ratio|0.91|||||TWO_SIDED|95.0|0.84|0.98||||||Pertussis filamentous hemagglutinin: CIs for GMC ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (Group 1 - Group 2 for pertussis filamentous hemagglutinin antigens).||0.98|0.84|
72384160|NCT01461980|144276060|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority criteria margin was 1.5-fold and statistical inference was based on the CIs of the GMC ratios. Non-inferiority was achieved when the lower limit of the 2-sided 95% CI for the GMC ratios after vaccination 1 was greater than 0.67.|GMC Ratio|0.88|||||TWO_SIDED|95.0|0.8|0.98||||||Pertussis pertactin: CIs for GMC ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (Group 1 - Group 2 for pertussis pertactin antigens).||0.98|0.80|
72384161|NCT01461980|144276060|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority criteria margin was 1.5-fold and statistical inference was based on the CIs of the GMC ratios. Non-inferiority was achieved when the lower limit of the 2-sided 95% CI for the GMC ratios after vaccination 1 was greater than 0.67.|GMC Ratio|0.9|||||TWO_SIDED|95.0|0.74|1.08||||||Pertussis fimbriae agglutinogens types 2 + 3: CIs for GMC ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (Group 1 - Group 2 for pertussis fimbriae agglutinogens types 2 + 3 antigens).||1.08|0.74|
72384162|NCT01461980|144276061|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority criteria margin was 1.5-fold and statistical inference was based on the CIs of the GMT ratios. Non-inferiority was achieved when the lower limit of the 2-sided 95% CI for the GMT ratios after vaccination 1 was greater than 0.67|GMT Ratio|0.91|||||TWO_SIDED|95.0|0.82|1.01||||||Serogroup A: CIs for GMT ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (Group 1 - Group 2 for Serogroup A antigens).||1.01|0.82|
72384163|NCT01461980|144276061|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority criteria margin was 1.5-fold and statistical inference was based on the CIs of the GMT ratios. Non-inferiority was achieved when the lower limit of the 2-sided 95% CI for the GMT ratios after vaccination 1 was greater than 0.67.|GMT Ratio|1.02|||||TWO_SIDED|95.0|0.9|1.15||||||Serogroup C: CIs for GMT ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (Group 1 - Group 2 for Serogroup C antigens).||1.15|0.90|
72384164|NCT01461980|144276061|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority criteria margin was 1.5-fold and statistical inference was based on the CIs of the GMT ratios. Non-inferiority was achieved when the lower limit of the 2-sided 95% CI for the GMT ratios after vaccination 1 was greater than 0.67.|GMT Ratio|0.99|||||TWO_SIDED|95.0|0.89|1.09||||||Serogroup Y: CIs for GMT ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (Group 1 - Group 2 for Serogroup Y antigens).||1.09|0.89|
72436278|NCT01193153|144385631|SUPERIORITY_OR_OTHER||Least Square Mean Difference|3.3|STANDARD_ERROR_OF_MEAN|1.33||0.014|TWO_SIDED|95.0|0.68|5.95||P-value based on change from DB baseline in PSP score and was analyzed using mixed-model repeated measures analysis of covariance based on observed data; within-participant repeated measures were modeled using an unstructured covariance matrix.|MMRM ANCOVA|||The null hypothesis is that there is no difference in the mean of the PSP total score between the two treatment groups.||5.95|0.68|0.014
72558280|NCT02554877|144645934|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|1.08|STANDARD_ERROR_OF_MEAN|0.48||0.0268|TWO_SIDED|90.0|0.28|1.88||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 4.||1.88|0.28|0.0268
72384165|NCT01461980|144276061|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority criteria margin was 1.5-fold and statistical inference was based on the CIs of the GMT ratios. Non-inferiority was achieved when the lower limit of the 2-sided 95% CI for the GMT ratios after vaccination 1 was greater than 0.67.|GMT Ratio|0.93|||||TWO_SIDED|95.0|0.83|1.04||||||Serogroup W-135: CIs for GMT ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (Group 1 - Group 2 for Serogroup W-135 antigens).||1.04|0.83|
72384166|NCT01461980|144276062|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority criteria margin was 1.5-fold and statistical inference was based on the CIs of the GMT ratios. Non-inferiority was achieved when the lower limit of the 2-sided 95% CI for the GMT ratios after vaccination 1 was greater than 0.67.|GMT Ratio|0.92|||||TWO_SIDED|95.0|0.84|1.02||||||PMB80 \[A22\]: CIs for GMT ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (Group 1 - Group 2 for hSBA strain titers).||1.02|0.84|
72384167|NCT01461980|144276062|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority criteria margin was 1.5-fold and statistical inference was based on the CIs of the GMT ratios. Non-inferiority was achieved when the lower limit of the 2-sided 95% CI for the GMT ratios after vaccination 1 was greater than 0.67.|GMT Ratio|0.9|||||TWO_SIDED|95.0|0.82|1.0||||||PMB2948 \[B24\]: CIs for GMT ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (Group 1 - Group 2 for hSBA strain titers).||1.00|0.82|
72384168|NCT02477839|144276075|OTHER||Mean Difference (Final Values)|0.97|||||TWO_SIDED|95.0|0.83|1.14|||ANCOVA|||Difference ratio in LS Mean was calculated as the exp \[LSMLCM-LSMplacebo\].||1.14|0.83|
72384169|NCT02477839|144276075|OTHER||Percent reduction|3.19|||=|0.6895|TWO_SIDED|95.0|-13.59|17.5|||ANCOVA|||Percent reduction over placebo was estimated as 100 x (1-exp \[LSMLCM-LSMPBO\]).||17.50|-13.59|=0.6895
72384170|NCT02607930|144276112|NON_INFERIORITY|A sample of approximately 600 participants randomized 1:1 achieves at least 95% power using a non-inferiority margin of 12% assuming a response rate in both groups of 91% (Reference Genvoya studies) and a one-sided alpha level of 0.025.|Difference in Percentages|-0.6|||||TWO_SIDED|95.002|-4.8|3.6|||||Differences in percentages of participants between groups and their 95.002% CIs were calculated based on Mantel-Haenszel (MH) proportions adjusted by baseline HIV-1 RNA stratum (≤ 100,000 vs. \> 100,000 copies/mL) and region stratum (US vs. Ex-US).|||3.6|-4.8|
72384171|NCT02607930|144276112|SUPERIORITY|||||||0.78|||||||Cochran-Mantel-Haenszel|p-value was calculated from CMH test stratified by baseline HIV-1 RNA stratum (≤ 100,000 vs. \> 100,000 copies/mL) and region stratum (US vs. Ex-US).||||||0.78
72384172|NCT02607930|144276113|OTHER||Difference in Percentages|-1.9|||||TWO_SIDED|95.0|-6.9|3.1|||||Differences in percentages of participants between groups and their 95% CIs were calculated based on Mantel-Haenszel (MH) proportions adjusted by baseline HIV-1 RNA stratum (≤ 100,000 vs. \> 100,000 copies/mL) and region stratum (US vs. Ex-US).|||3.1|-6.9|
72384173|NCT02607930|144276113|OTHER|||||||0.45|||||||Cochran-Mantel-Haenszel|p-value was calculated from CMH test stratified by baseline HIV-1 RNA stratum (≤ 100,000 vs. \> 100,000 copies/mL) and region stratum (US vs. Ex-US).||||||0.45
72384174|NCT02607930|144276114|OTHER||Difference in Percentages|-2.6|||||TWO_SIDED|95.0|-8.5|3.4|||||Differences in percentages of participants between groups and their 95% CIs were calculated based on MH proportions adjusted by baseline HIV-1 RNA stratum (≤ 100,000 vs. \> 100,000 copies/mL) and region stratum (US vs. Ex-US).|||3.4|-8.5|
72384175|NCT02607930|144276114|OTHER|||||||0.39|||||||Cochran-Mantel-Haenszel|p-value was calculated from CMH test stratified by baseline HIV-1 RNA stratum (≤ 100,000 vs. \> 100,000 copies/mL) and region stratum (US vs. Ex-US).||||||0.39
72384176|NCT02607930|144276115|OTHER||Difference in Percentages|0.4|||||TWO_SIDED|95.0|-4.8|5.6|||||The differences in percentages of participants between treatment groups and their 95% CIs were calculated based on the MH proportions adjusted by baseline HIV-1 RNA stratum (≤ 100,000 vs. \> 100,000 copies/mL) and region stratum (US vs. Ex-US).|||5.6|-4.8|
72384177|NCT02607930|144276115|OTHER|||||||0.87|||||||Cochran-Mantel-Haenszel|p-value was calculated from CMH test stratified by baseline HIV-1 RNA stratum (≤ 100,000 vs. \> 100,000 copies/mL) and region stratum (US vs. Ex-US).||||||0.87
72558281|NCT02554877|144645934|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|1.39|STANDARD_ERROR_OF_MEAN|0.49||0.0047|TWO_SIDED|90.0|0.58|2.19||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 4.||2.19|0.58|0.0047
72384178|NCT02607930|144276116|OTHER||Difference in Percentages|-1.2|||||TWO_SIDED|95.0|-6.9|4.6|||||The differences in percentages of participants between treatment groups and their 95% CIs were calculated based on the MH proportions adjusted by baseline HIV-1 RNA stratum (≤ 100,000 vs. \> 100,000 copies/mL) and region stratum (US vs. Ex-US).|||4.6|-6.9|
72384179|NCT02607930|144276116|OTHER|||||||0.69|||||||Cochran-Mantel-Haenszel|p-value was calculated from CMH test stratified by baseline HIV-1 RNA stratum (≤ 100,000 vs. \> 100,000 copies/mL) and region stratum (US vs. Ex-US).||||||0.69
72384180|NCT02607930|144276117|OTHER||Difference in Percentages|-4.2|||||TWO_SIDED|95.0|-10.5|2.1|||||The differences in percentages of participants between treatment groups and their 95% CIs were calculated based on the MH proportions adjusted by baseline HIV-1 RNA stratum (≤ 100,000 vs. \> 100,000 copies/mL) and region stratum (US vs. Ex-US).|||2.1|-10.5|
72384181|NCT02607930|144276117|OTHER|||||||0.19|||||||Cochran-Mantel-Haenszel|p-value was calculated from CMH test stratified by baseline HIV-1 RNA stratum (≤ 100,000 vs. \> 100,000 copies/mL) and region stratum (US vs. Ex-US).||||||0.19
72384182|NCT02607930|144276118|OTHER||Difference in LSM|-0.03||||0.48|TWO_SIDED|95.0|-0.12|0.06|||ANOVA|p-value was adjusted by baseline HIV-1 RNA stratum and region stratum.|Difference in least-squares mean (LSM), and its 95% confidence interval (CI) were adjusted by baseline HIV-1 RNA stratum and region stratum.|||0.06|-0.12|0.48
72384183|NCT02607930|144276119|OTHER||Difference in LSM|0.0||||0.99|TWO_SIDED|95.0|-0.09|0.09|||ANOVA||Difference in LSM, and its 95% CI were adjusted by baseline HIV-1 RNA stratum and region stratum.|||0.09|-0.09|0.99
72558282|NCT02554877|144645934|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|1.07|STANDARD_ERROR_OF_MEAN|0.42||0.0116|TWO_SIDED|90.0|0.38|1.76||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 8.||1.76|0.38|0.0116
72384184|NCT02607930|144276120|OTHER||Difference in LSM|0.01||||0.88|TWO_SIDED|95.0|-0.08|0.1|||ANOVA||Difference in LSM, and its 95% CI were adjusted by baseline HIV-1 RNA stratum and region stratum.|||0.10|-0.08|0.88
72384185|NCT02607930|144276121|OTHER||Difference in LSM|6.0||||0.69|TWO_SIDED|95.0|-24.0|36.0|||ANOVA|P-value was adjusted by the baseline HIV-1 RNA and region stratum.|Difference in LSM, and its 95% CI were adjusted by the baseline HIV-1 RNA and region stratum.|||36|-24|0.69
72384186|NCT02607930|144276122|OTHER||Difference in LSM|-1.0||||0.94|TWO_SIDED|95.0|-39.0|36.0|||ANOVA|P-value was adjusted by the baseline HIV-1 RNA and region stratum.|Difference in LSM, and its 95% CI were adjusted by the baseline HIV-1 RNA and region stratum.|||36|-39|0.94
72384187|NCT02607930|144276123|OTHER||Difference in LSM|-20.0||||0.3|TWO_SIDED|95.0|-59.0|18.0|||ANOVA|p-value was adjusted by baseline HIV-1 RNA stratum and region stratum.|Difference in LSM, and its 95% CI were adjusted by baseline HIV-1 RNA stratum and region stratum.|||18|-59|0.30
72384188|NCT02607930|144276124|OTHER||Difference in LSM|0.346||||0.092|TWO_SIDED|95.0|-0.057|0.748|||ANOVA|||||0.748|-0.057|0.092
72384189|NCT02607930|144276125|OTHER||Difference in LSM|0.135||||0.59|TWO_SIDED|95.0|-0.356|0.625|||ANOVA|||||0.625|-0.356|0.59
72384190|NCT02607930|144276126|OTHER||Difference in LSM|0.271||||0.39|TWO_SIDED|95.0|-0.351|0.893|||ANOVA|||||0.893|-0.351|0.39
72384191|NCT02607930|144276127|OTHER||Difference in LSM|-0.221||||0.41|TWO_SIDED|95.0|-0.741|0.3|||ANOVA|||||0.300|-0.741|0.41
72384192|NCT02607930|144276128|OTHER||Difference in LSM|-0.485||||0.14|TWO_SIDED|95.0|-1.126|0.155|||ANOVA|||||0.155|-1.126|0.14
72384193|NCT02607930|144276129|OTHER||Difference in LSM|-0.406||||0.26|TWO_SIDED|95.0|-1.119|0.307|||ANOVA|||||0.307|-1.119|0.26
72384194|NCT03198078|144276136|SUPERIORITY||LS mean difference|-5.33||||0.0136|TWO_SIDED|95.0|-9.55|-1.1||P-value was analyzed by MMRM method with fixed effect of treatment, (pooled) clinical center visit, treatment visit interaction, baseline value, and baseline visit interaction as a covariate, and with an unstructured covariance.|MMRM|||||-1.10|-9.55|0.0136
72436279|NCT01193153|144385633|SUPERIORITY_OR_OTHER||Least Square Mean Difference|4.5|||<|0.001|TWO_SIDED|95.0|1.94|7.15||Change at Endpoint (Week 64/LOCF)|ANCOVA|||||7.15|1.94|<0.001
72384195|NCT03198078|144276136|SUPERIORITY||LS mean difference|-6.53||||0.0032|TWO_SIDED|95.0|-10.8|-2.21||P-value was analyzed by MMRM method with fixed effect of treatment, (pooled) clinical center visit, treatment visit interaction, baseline value, and baseline visit interaction as a covariate, and with an unstructured covariance.|MMRM|||||-2.21|-10.8|0.0032
72618757|NCT01026038|144768112|SUPERIORITY_OR_OTHER||Percent Difference|0.0|||||TWO_SIDED|95.0|-3.5|6.7||||||Serotype 4: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 13vPnC/13vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/7vPnC/13vPnC along with exact 2-sided 95% CI.||6.7|-3.5|
72384196|NCT03198078|144276137|SUPERIORITY||LS mean difference|-1.44||||0.0205|TWO_SIDED|95.0|-2.65|-0.22||P-value was analyzed by MMRM method with fixed effect of treatment, (pooled) clinical center visit, treatment visit interaction, baseline value, and baseline visit interaction as a covariate, and with an unstructured covariance.|MMRM|||Change From Baseline to Week 6 in PANSS Positive Sub-scale Score||-0.22|-2.65|0.0205
72384197|NCT03198078|144276137|SUPERIORITY||LS mean difference|-2.15||||0.0008|TWO_SIDED|95.0|-3.4|-0.91||P-value was analyzed by MMRM method with fixed effect of treatment, (pooled) clinical center visit, treatment visit interaction, baseline value, and baseline visit interaction as a covariate, and with an unstructured covariance.|MMRM|||Change From Baseline to Week 6 in PANSS Positive Sub-scale Score||-0.91|-3.40|0.0008
72384198|NCT03198078|144276137|SUPERIORITY||LS mean difference|-0.88||||0.136|TWO_SIDED|95.0|-2.04|0.28||P-value was analyzed by MMRM method with fixed effect of treatment, (pooled) clinical center visit, treatment visit interaction, baseline value, and baseline visit interaction as a covariate, and with an unstructured covariance.|MMRM|||Change From Baseline to Week 6 in PANSS Negative Sub-scale Score||0.28|-2.04|0.1360
72384199|NCT03198078|144276137|SUPERIORITY||LS mean difference|-0.95||||0.1158|TWO_SIDED|95.0|-2.14|0.24||P-value was analyzed by MMRM method with fixed effect of treatment, (pooled) clinical center visit, treatment visit interaction, baseline value, and baseline visit interaction as a covariate, and with an unstructured covariance.|MMRM|||Change From Baseline to Week 6 in PANSS Negative Sub-scale Score||0.24|-2.14|0.1158
72384200|NCT03198078|144276138|SUPERIORITY||Ratio of Response Rate|1.55||||0.0111|TWO_SIDED|95.0|1.09|2.2|||Cochran-Mantel-Haenszel|P-value was analyzed by Cochran-Mantel-Haenszel (CMH) general association test controlling for (pooled) centers.||||2.20|1.09|0.0111
72384201|NCT03198078|144276138|SUPERIORITY||Ratio of Response Rate|1.51||||0.0224|TWO_SIDED|95.0|1.06|2.16|||Cochran-Mantel-Haenszel|P-value was analyzed by CMH general association test controlling for (pooled) centers.||||2.16|1.06|0.0224
72384202|NCT03198078|144276139|SUPERIORITY||Ratio of Remission Rate|1.18||||0.4415|TWO_SIDED|95.0|0.77|1.81|||Cochran-Mantel-Haenszel|P-value was analyzed by CMH general association test controlling for (pooled) centers.||||1.81|0.77|0.4415
72384203|NCT03198078|144276139|SUPERIORITY||Ratio of Remission Rate|1.48||||0.0472|TWO_SIDED|95.0|1.01|2.16|||Cochran-Mantel-Haenszel|P-value was analyzed by CMH general association test controlling for (pooled) centers.||||2.16|1.01|0.0472
72384204|NCT03198078|144276140|SUPERIORITY||LS mean difference|2.48||||0.0854|TWO_SIDED|95.0|-0.35|5.31||P-value was analyzed by MMRM method with fixed effect of treatment, (pooled) clinical center visit, treatment visit interaction, baseline value, and baseline visit interaction as a covariate, and with an unstructured covariance.|MMRM|||||5.31|-0.35|0.0854
72436280|NCT03951649|144385738|SUPERIORITY|||||||0.3|||||||Chi-squared|||||||0.30
72436281|NCT03951649|144385739|SUPERIORITY||||||>|0.99||||||The p-value was calculated using a 2 sided Wilcoxon rank sum test.|Wilcoxon (Mann-Whitney)|||||||>0.99
72436282|NCT03951649|144385740|SUPERIORITY|||||||0.19|||||||Chi-squared|||||||0.19
72436283|NCT03951649|144385741|SUPERIORITY|||||||0.028|||||||Wilcoxon (Mann-Whitney)|||||||0.028
72436284|NCT03951649|144385742|SUPERIORITY|||||||1||||||P-value was calculated|Fisher Exact|||||||1.00
72436285|NCT03951649|144385743|SUPERIORITY|||||||0.61|||||||Wilcoxon (Mann-Whitney)|||||||0.61
72558283|NCT02554877|144645934|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|0.97|STANDARD_ERROR_OF_MEAN|0.42||0.022|TWO_SIDED|90.0|0.27|1.66||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 8.||1.66|0.27|0.0220
72384205|NCT03198078|144276140|SUPERIORITY||LS mean difference|3.99||||0.0072|TWO_SIDED|95.0|1.09|6.88||P-value was analyzed by MMRM method with fixed effect of treatment, (pooled) clinical center visit, treatment visit interaction, baseline value, and baseline visit interaction as a covariate, and with an unstructured covariance.|MMRM|||||6.88|1.09|0.0072
72384206|NCT03198078|144276141|SUPERIORITY||LS mean difference|-0.11||||0.3589|TWO_SIDED|95.0|-0.36|0.13||P-value was analyzed by MMRM method with fixed effect of treatment, (pooled) clinical center visit, treatment visit interaction, baseline value, and baseline visit interaction as a covariate, and with an unstructured covariance.|MMRM|||||0.13|-0.36|0.3589
72384207|NCT03198078|144276141|SUPERIORITY||LS mean difference|-0.2||||0.1118|TWO_SIDED|95.0|-0.45|0.05||P-value was analyzed by MMRM method with fixed effect of treatment, (pooled) clinical center visit, treatment visit interaction, baseline value, and baseline visit interaction as a covariate, and with an unstructured covariance.|MMRM|||||0.05|-0.45|0.1118
72384208|NCT03198078|144276142|SUPERIORITY||Mean Difference (Final Values)|-0.29||||0.0287|TWO_SIDED|95.0|-0.56|-0.03|||Cochran-Mantel-Haenszel|P-value was analyzed by CMH row mean scores differ test controlling for study center.||||-0.03|-0.56|0.0287
72384209|NCT03198078|144276142|SUPERIORITY||Mean Difference (Final Values)|-0.34||||0.0184|TWO_SIDED|95.0|-0.62|-0.06|||Cochran-Mantel-Haenszel|P-value was analyzed by CMH row mean scores differ test controlling for study center.||||-0.06|-0.62|0.0184
72384210|NCT03198078|144276153|SUPERIORITY||LS mean difference|0.07|||||TWO_SIDED|95.0|-0.24|0.39|||||LS mean difference was analyzed by ANCOVA model, with treatment and study center as main effects and baseline value as covariate.|||0.39|-0.24|
72384211|NCT03198078|144276153|SUPERIORITY||LS mean difference|0.18|||||TWO_SIDED|95.0|-0.14|0.51|||||LS mean difference was analyzed by ANCOVA model, with treatment and study center as main effects and baseline value as covariate.|||0.51|-0.14|
72384212|NCT03198078|144276154|SUPERIORITY||LS mean difference|-0.06|||||TWO_SIDED|95.0|-0.3|0.18|||||LS mean difference was analyzed by ANCOVA model, with treatment and study center as main effects and baseline value as covariate.|||0.18|-0.30|
72384213|NCT03198078|144276154|SUPERIORITY||LS mean difference|0.11|||||TWO_SIDED|95.0|-0.13|0.36|||||LS mean difference was analyzed by ANCOVA model, with treatment and study center as main effects and baseline value as covariate.|||0.36|-0.13|
72384214|NCT03198078|144276155|SUPERIORITY||LS mean difference|0.0|||||TWO_SIDED|95.0|-0.08|0.09|||||LS mean difference was analyzed by ANCOVA model, with treatment and study center as main effects and baseline value as covariate.|||0.09|-0.08|
72384215|NCT03198078|144276155|SUPERIORITY||LS mean difference|0.05|||||TWO_SIDED|95.0|-0.04|0.14|||||LS mean difference was analyzed by ANCOVA model, with treatment and study center as main effects and baseline value as covariate.|||0.14|-0.04|
72384216|NCT00057876|144276158|SUPERIORITY_OR_OTHER_LEGACY|||||||0.017|ONE_SIDED|95.0|||||Log Rank|||Log rank test is conducted for OS to see whether the two treatment arms are different in their overall survival probabilities.||||0.017
72384217|NCT00057876|144276159|SUPERIORITY_OR_OTHER_LEGACY|||||||0.25|ONE_SIDED|95.0|||||Log Rank|||||||0.25
72384218|NCT00057876|144276160|SUPERIORITY_OR_OTHER_LEGACY|||||||0.99|||||||Fisher Exact|||Compare objective response rate (CR+PR) between two treatment groups||||0.99
72384219|NCT02907268|144276170|EQUIVALENCE|"Each variable compared with the no change score. The no change score is 0 for wrinkles-related variables."|||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
72384220|NCT02907268|144276171|EQUIVALENCE|"Each variable compared with the no change score. The no change score is 0 for wrinkles-related variables."|||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
72384221|NCT02907268|144276172|EQUIVALENCE|"Each variable compared with the no change score. The no change score is 0 for wrinkles-related variables."|||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
72384222|NCT00457366|144276182|OTHER|We used an analysis of covariance (ANCOVA) with baseline as the covariate to analyze the PANSS-EC at hour 2.|||||>|0.05|||||||ANCOVA|||||||>0.05
72384223|NCT02080637|144276184|OTHER||Mean Difference (Final Values)|-0.5|STANDARD_DEVIATION|0.5||0.01|TWO_SIDED||||||Paired t-test|||Baseline versus 2 hours post-ambrisentan||||0.01
72384224|NCT02080637|144276185|OTHER||Slope|-27.0||||0.94|TWO_SIDED|95.0|-775.0|723.0|||Regression, Linear|||||723|-775|0.94
72384225|NCT02080637|144276186|OTHER||Slope|1.2||||0.61|TWO_SIDED|95.0|-3.9|6.3|||Regression, Linear|||||6.3|-3.9|0.61
72384226|NCT02770170|144276219|OTHER|||||||0.7271||||||An alpha of 0.20 was used for one-sided test. The MCPMod procedure adjusts for multiplicity.|MCPMod quadratic model fit|||Multiple comparison procedures and modelling (MCPmod) techniques for logistic regression was used.||||0.7271
72384227|NCT02770170|144276219|OTHER|||||||0.6415||||||An alpha of 0.20 was used for one-sided test. The MCPMod procedure adjusts for multiplicity.|MCPMod sigmoidal Emax model fit|||Multiple comparison procedures and modelling (MCPmod) techniques for logistic regression was used.||||0.6415
72384228|NCT02770170|144276219|OTHER|||||||0.7367||||||An alpha of 0.20 was used for one-sided test. The MCPMod procedure adjusts for multiplicity.|MCPMod Emax model fit|||Multiple comparison procedures and modelling (MCPmod) techniques for logistic regression was used.||||0.7367
72384229|NCT02770170|144276219|OTHER|||||||0.6624||||||An alpha of 0.20 was used for one-sided test. The MCPMod procedure adjusts for multiplicity.|MCPMod exponential model fit|||Multiple comparison procedures and modelling (MCPmod) techniques for logistic regression was used.||||0.6624
72384230|NCT02770170|144276219|OTHER||Risk Difference (RD)|-10.0||||0.4645|TWO_SIDED|80.0|-27.292|7.288|||Regression, Logistic|include treatment and covariates, race (Asian or non-Asian), proteinuria at screening (\<3g/day or \>= 3g/day)|Confidence intervals calculated using delta method|||7.288|-27.292|0.4645
72436286|NCT03951649|144385744|SUPERIORITY|||||||0.43|||||||Fisher Exact|||||||0.43
72436287|NCT03951649|144385746|SUPERIORITY|||||||0.19|||||||Fisher Exact|||||||0.19
72436288|NCT03951649|144385747|SUPERIORITY|||||||0.18|||||||Fisher Exact|||||||0.18
72436289|NCT03951649|144385748|SUPERIORITY|||||||0.92|||||||Fisher Exact|||||||0.92
72436290|NCT03951649|144385749|SUPERIORITY|||||||0.13|||||||Wilcoxon (Mann-Whitney)|||||||0.13
72436291|NCT03951649|144385750|SUPERIORITY|||||||0.14|||||||Fisher Exact|||||||0.14
72558284|NCT02554877|144645934|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|1.31|STANDARD_ERROR_OF_MEAN|0.42||0.0021|TWO_SIDED|90.0|0.62|2.01||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 8.||2.01|0.62|0.0021
72384231|NCT02770170|144276219|OTHER||Risk Difference (RD)|-3.38||||0.8084|TWO_SIDED|80.0|-21.204|14.451|||Regression, Logistic|include treatment and covariates, race (Asian or non-Asian), proteinuria at screening (\<3g/day or \>= 3g/day)|Confidence intervals calculated using delta method|||14.451|-21.204|0.8084
72494525|NCT05064059|144518462|SUPERIORITY||Hazard Ratio (HR)|0.98||||0.4183|TWO_SIDED|95.0|0.8|1.2||One-sided p-value based on log-rank test stratified by geographic region (Asia Pacific; EMEA/Americas), presence of liver metastasis (Yes/No) and time from initial diagnosis of metastatic disease to randomization (\>=18 months, \<18 months).|Log Rank||HR and 95% CI were based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by geographic region, presence of liver metastasis \& time from initial diagnosis of metastatic disease to randomization.|||1.20|0.80|0.4183
72494526|NCT05064059|144518463|SUPERIORITY||Hazard Ratio (HR)|1.34||||0.9967|TWO_SIDED|95.0|1.09|1.64||One-sided nominal p-value based on log-rank test stratified by geographic region (Asia Pacific; EMEA/Americas), presence of liver metastasis (Yes/No) and time from initial diagnosis of metastatic disease to randomization (\>=18 months, \<18 months).|Log Rank||HR and 95% CI were based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by geographic region, presence of liver metastasis \& time from initial diagnosis of metastatic disease to randomization.|||1.64|1.09|0.9967
72494527|NCT05064059|144518464|SUPERIORITY||Difference in percentage|5.9||||0.0007|TWO_SIDED|95.0|2.5|10.1||One-sided, nominal p-value for testing. H0: difference in % = 0 versus H1: difference in % \> 0.|Miettinen & Nurminen Method||Difference in percentage and 95% CI were based on the Miettinen \& Nurminen method stratified by geographic region, presence of liver metastasis \& time from initial diagnosis of metastatic disease to randomization.|||10.1|2.5|0.0007
72494528|NCT05064059|144518468|OTHER||Difference in Least Square (LS) Means|-3.08||||0.1318|TWO_SIDED|95.0|-7.09|0.93||Two-sided p-value based on t-test.|t-test, 2 sided||Calculated using a cLDA model with PRO scores as response variable with covariates for treatment by study visit interaction \& stratified by geographic region, presence of liver metastasis \& time from diagnosis of metastatic disease to randomization.|||0.93|-7.09|0.1318
72494529|NCT05064059|144518469|OTHER||Difference in LS Means|-0.95||||0.637|TWO_SIDED|95.0|-4.93|3.02||Two-sided p-value based on t-test.|t-test, 2 sided||Calculated using a cLDA model with PRO scores as response variable with covariates for treatment by study visit interaction \& stratified by geographic region, presence of liver metastasis \& time from diagnosis of metastatic disease to randomization.|||3.02|-4.93|0.6370
72494530|NCT05064059|144518470|OTHER||Difference in LS Means|3.86||||0.1846|TWO_SIDED|95.0|-1.85|9.57||Two-sided p-value based on t-test.|t-test, 2 sided||Calculated using a cLDA model with PRO scores as response variable with covariates for treatment by study visit interaction \& stratified by geographic region, presence of liver metastasis \& time from diagnosis of metastatic disease to randomization.|||9.57|-1.85|0.1846
72494531|NCT05064059|144518471|OTHER||Difference in LS Means|0.56||||0.841|TWO_SIDED|95.0|-4.96|6.08||Two-sided p-value based on t-test.|t-test, 2 sided||Calculated using a cLDA model with PRO scores as response variable with covariates for treatment by study visit interaction \& stratified by geographic region, presence of liver metastasis \& time from diagnosis of metastatic disease to randomization.|||6.08|-4.96|0.8410
72558285|NCT02554877|144645934|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|1.41|STANDARD_ERROR_OF_MEAN|0.51||0.0067|TWO_SIDED|90.0|0.56|2.26||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 12.||2.26|0.56|0.0067
72558286|NCT02554877|144645934|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|1.18|STANDARD_ERROR_OF_MEAN|0.51||0.0225|TWO_SIDED|90.0|0.33|2.02||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 12.||2.02|0.33|0.0225
72384232|NCT02770170|144276219|OTHER||Risk Difference (RD)|-3.77||||0.7398|TWO_SIDED|80.0|-18.364|10.832|||Regression, Logistic|include treatment and covariates, race (Asian or non-Asian), proteinuria at screening (\<3g/day or \>= 3g/day)|Confidence intervals calculated using delta method|||10.832|-18.364|0.7398
72384233|NCT02770170|144276220|OTHER||Risk Difference (RD)|-8.93||||0.5773|TWO_SIDED|80.0|-23.66|7.64|||Barnard test of association||Unadjusted absolute risk difference; Confidence intervals calculated using Newcombe method|||7.64|-23.66|0.5773
72384234|NCT02770170|144276220|OTHER||Risk Difference (RD)|12.5||||0.4013|TWO_SIDED|80.0|-4.59|29.03|||Barnard test of association||Unadjusted absolute risk difference; Confidence intervals calculated using Newcombe method|||29.03|-4.59|0.4013
72384235|NCT02770170|144276220|OTHER||Risk Difference (RD)|-2.5||||0.8965|TWO_SIDED|80.0|-15.98|11.1|||Barnard test of association||Unadjusted absolute risk difference; Confidence intervals calculated using Newcombe method|||11.10|-15.98|0.8965
72384236|NCT02770170|144276221|OTHER||Risk Difference (RD)|-19.64||||0.1476|TWO_SIDED|80.0|-35.38|-2.48|||Barnard test of association||Unadjusted absolute risk difference; Confidence intervals calculated using Newcombe method|||-2.48|-35.38|0.1476
72384237|NCT02770170|144276221|OTHER||Risk Difference (RD)|12.5||||0.4013|TWO_SIDED|80.0|-4.2|26.86|||Barnard test of association||Unadjusted absolute risk difference; Confidence intervals calculated using Newcombe method|||26.86|-4.20|0.4013
72384238|NCT02770170|144276221|OTHER||Risk Difference (RD)|0.0|||||TWO_SIDED|80.0|-13.63|13.63|||Barnard test of association||Unadjusted absolute risk difference; Confidence intervals calculated using Newcombe method|||13.63|-13.63|
72384239|NCT02770170|144276222|OTHER||Risk Difference (RD)|-26.67||||0.0512|TWO_SIDED|80.0|-41.52|-9.42|||Barnard test of association||Unadjusted absolute risk difference; Confidence intervals calculated using Newcombe method|||-9.42|-41.52|0.0512
72558287|NCT02554877|144645934|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|1.4|STANDARD_ERROR_OF_MEAN|0.51||0.0073|TWO_SIDED|90.0|0.55|2.25||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 12.||2.25|0.55|0.0073
72384240|NCT02770170|144276222|OTHER||Risk Difference (RD)|5.0||||0.7597|TWO_SIDED|80.0|-12.1|20.74|||Barnard test of association||Unadjusted absolute risk difference; Confidence intervals calculated using Newcombe method|||20.74|-12.10|0.7597
72384241|NCT02770170|144276222|OTHER||Risk Difference (RD)|-5.0||||0.7505|TWO_SIDED|80.0|-18.74|9.02|||Barnard test of association||Unadjusted absolute risk difference; Confidence intervals calculated using Newcombe method|||9.02|-18.74|0.7505
72384242|NCT02770170|144276223|OTHER||Risk Difference (RD)|-21.43||||0.1269|TWO_SIDED|80.0|-36.03|-4.41|||Barnard test of association||Unadjusted absolute risk difference; Confidence intervals calculated using Newcombe method|||-4.41|-36.03|0.1269
72384243|NCT02770170|144276223|OTHER||Risk Difference (RD)|5.0||||0.7889|TWO_SIDED|80.0|-12.24|21.62|||Barnard test of association||Unadjusted absolute risk difference; Confidence intervals calculated using Newcombe method|||21.62|-12.24|0.7889
72384244|NCT02770170|144276223|OTHER||Risk Difference (RD)|-12.5||||0.2906|TWO_SIDED|80.0|-25.99|1.68|||Barnard test of association||Unadjusted absolute risk difference; Confidence intervals calculated using Newcombe method|||1.68|-25.99|0.2906
72384245|NCT02770170|144276224|OTHER||Risk Difference (RD)|-9.64||||0.5687|TWO_SIDED|80.0|-25.79|7.45|||Barnard test of association||Unadjusted absolute risk difference; Confidence intervals calculated using Newcombe method|||7.45|-25.79|0.5687
72384246|NCT02770170|144276224|OTHER||Risk Difference (RD)|2.5||||0.9217|TWO_SIDED|80.0|-14.67|19.17|||Barnard test of association||Unadjusted absolute risk difference; Confidence intervals calculated using Newcombe method|||19.17|-14.67|0.9217
72384247|NCT02770170|144276224|OTHER||Risk Difference (RD)|0.0|||||TWO_SIDED|80.0|-14.03|14.03|||Barnard test of association||Unadjusted absolute risk difference; Confidence intervals calculated using Newcombe method|||14.03|-14.03|
72384248|NCT02979197|144276245|NON_INFERIORITY|A two-sample t-test was used to test the one-sided hypothesis that treatment with Amlodipine+Celecoxib (arm 1) was non-inferior to half of the effect achieved with Amlodipine+Placebo (arm 2). The primary efficacy endpoint was considered met if the lower limits of the 97.5% one-side confidence interval (CI) for the difference in SBPday change in arm 1 and 50% of the mean change in arm 2 was less than 0.||||||0.024|||||||t-test, 2 sided|||LOCF method was used. Primary efficacy analysis was based on the difference between the Amlodipine+Celecoxib and Amlodipine+Placebo (arms 1 and 2, respectively) in the mean change in SBPday from Baseline to final (Day 13), where a subject completed the 14-day treatment plan, or to Day 6, where a subject was withdrawn from treatment before the Day 13 dose but after the Day 6 dose, or to baseline, where a subject was withdrawn before the Day 6 dose.||||0.024
72384249|NCT02979197|144276246|OTHER|ANOVA F-test was used to compare the mean changes in body weight from baseline to end of treatment among the three treatment arms. The omni-bus test was to conclude if any differences existed.||||||0.006|||||||ANOVA|||A serial gatekeeping strategy was used for secondary efficacy analyses. If, and only if, statistical significance was achieved for the primary endpoint (SBPday), a secondary hierarchical analysis was to be used to evaluate secondary efficacy endpoints and was only to proceed from one to the next if the alpha was met for the prior; if the alpha was not met, analysis was performed for informational purposes only. Mean change in body weight was the 1st of the four secondary efficacy endpoints.||||0.006
72384250|NCT02979197|144276247|SUPERIORITY|A two-sample t-test for superiority was used to test the one-sided hypothesis that treatment with Amlodipine+Celecoxib lowered SBP24h to a greater degree than Amlodipine+Placebo.||||||0.826|||||||t-test, 2 sided|||A serial gatekeeping strategy was used for secondary efficacy analyses. If, and only if, statistical significance was achieved for the primary endpoint (SBPday), a secondary hierarchical analysis was to be used to evaluate secondary efficacy endpoints and was only to proceed from one to the next if the alpha was met for the prior; if the alpha was not met, analysis was performed for informational purposes only. Mean change in SBP24h was the 2nd of the four secondary efficacy endpoints.||||0.826
72384251|NCT02979197|144276248|SUPERIORITY|A two-sample t-test for superiority was used to test the one-sided hypothesis that treatment with Amlodipine+Celecoxib lowered DBP24h to a greater degree than Amlodipine+Placebo.||||||0.5|||||||t-test, 2 sided|||A serial gatekeeping strategy was used for secondary efficacy analyses. If, and only if, statistical significance was achieved for the primary endpoint (SBPday), a secondary hierarchical analysis was to be used to evaluate secondary efficacy endpoints and was only to proceed from one to the next if the alpha was met for the prior; if the alpha was not met, analysis was performed for informational purposes only. Mean change in DBP24h was the 3rd of the 4 secondary efficacy endpoints.||||0.500
72384252|NCT02979197|144276249|SUPERIORITY|A two-sample t-test for superiority was used to test the one-sided hypothesis that treatment with Amlodipine+Celecoxib improved creatinine clearance to a greater degree than Amlodipine+Placebo.||||||0.668|||||||t-test, 2 sided|||A serial gatekeeping strategy was used for secondary efficacy analyses. If, and only if, statistical significance was achieved for the primary endpoint (SBPday), a secondary hierarchical analysis was to be used to evaluate secondary efficacy endpoints and was only to proceed from one to the next if the alpha was met for the prior; if the alpha was not met, analysis was performed for informational purposes only. Mean change in creatinine clearance was the 4th of 4 secondary efficacy endpoints.||||0.668
72384253|NCT02979197|144276250|SUPERIORITY|Differences in the occurrence of TEAEs between treatment arms were evaluated using Chi-square test.||||||0.675|||||||Chi-squared|Computed on the number of subjects who had at least one TEAE.||||||0.675
72384254|NCT02979197|144276250|SUPERIORITY|||||||0.555|||||||Regression, Logistic|TEAE (1=at least one TEAE occurred for the subject; 0=otherwise) as dependent variable and treatment as fixed effect.||||||0.555
72384255|NCT02979197|144276251|SUPERIORITY|||||||0.226|||||||t-test, 2 sided|||For this analysis, all values below the limit of quantification were treated as 0.||||0.226
72384256|NCT02979197|144276252|SUPERIORITY|||||||0.215|||||||t-test, 2 sided|||For this analysis, all values below the limit of quantification (BLQ) were treated as 0.04 ng/mL. Assignment of BLQ values to a nonzero number allowed computation of the log transformation. The selection of 0.04 ng/mL was based on the lower limit of quantification of the validated bioanalytical method (0.05 ng/mL) and selecting the next lowest number at the hundredth decimal place.||||0.215
72436292|NCT03951649|144385751|SUPERIORITY|||||||0.23|||||||Fisher Exact|||||||0.23
72558288|NCT02554877|144645934|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|0.3|STANDARD_ERROR_OF_MEAN|0.26||0.2391|TWO_SIDED|90.0|-0.12|0.73||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 2. The readings with residual greater than 3.5 times of its standard derivation were excluded from the presentation. (Excluding outliers)||0.73|-0.12|0.2391
72558289|NCT02554877|144645934|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|0.0|STANDARD_ERROR_OF_MEAN|0.26||0.9912|TWO_SIDED|90.0|-0.42|0.43||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 2. The readings with residual greater than 3.5 times of its standard derivation were excluded from the presentation. (Excluding outliers)||0.43|-0.42|0.9912
72558290|NCT02554877|144645934|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|0.34|STANDARD_ERROR_OF_MEAN|0.26||0.193|TWO_SIDED|90.0|-0.09|0.77||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 2. The readings with residual greater than 3.5 times of its standard derivation were excluded from the presentation. (Excluding outliers)||0.77|-0.09|0.1930
72558291|NCT02554877|144645934|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|0.8|STANDARD_ERROR_OF_MEAN|0.27||0.0038|TWO_SIDED|90.0|0.35|1.25||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 4. The readings with residual greater than 3.5 times of its standard derivation were excluded from the presentation. (Excluding outliers)||1.25|0.35|0.0038
72558292|NCT02554877|144645934|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|0.57|STANDARD_ERROR_OF_MEAN|0.27||0.0394|TWO_SIDED|90.0|0.12|1.02||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 4. The readings with residual greater than 3.5 times of its standard derivation were excluded from the presentation.(Excluding outliers)||1.02|0.12|0.0394
72558293|NCT02554877|144645934|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|0.48|STANDARD_ERROR_OF_MEAN|0.28||0.0862|TWO_SIDED|90.0|0.02|0.93||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 4. The readings with residual greater than 3.5 times of its standard derivation were excluded from the presentation.(Excluding outliers)||0.93|0.02|0.0862
72558294|NCT02554877|144645934|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|1.05|STANDARD_ERROR_OF_MEAN|0.34||0.0024|TWO_SIDED|90.0|0.48|1.61||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 8. The readings with residual greater than 3.5 times of its standard derivation were excluded from the presentation.(Excluding outliers)||1.61|0.48|0.0024
72558295|NCT02554877|144645934|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|0.92|STANDARD_ERROR_OF_MEAN|0.34||0.0068|TWO_SIDED|90.0|0.37|1.48||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 8. The readings with residual greater than 3.5 times of its standard derivation were excluded from the presentation.(Excluding outliers)||1.48|0.37|0.0068
72558296|NCT02554877|144645934|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|0.86|STANDARD_ERROR_OF_MEAN|0.34||0.0132|TWO_SIDED|90.0|0.29|1.42||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 8. The readings with residual greater than 3.5 times of its standard derivation were excluded from the presentation.(Excluding outliers)||1.42|0.29|0.0132
72436293|NCT00758602|144385765|SUPERIORITY_OR_OTHER||LS Mean difference|0.6581||||0.0813|TWO_SIDED|95.0|-0.08|1.4||p-value, least squares (LS) mean difference, and 95% confidence interval (CI) based on analysis of covariance (ANCOVA) model with treatment, center, and the treatment-by-center interaction as fixed effects, and the donor age as a covariate.|ANCOVA|||||1.40|-0.08|0.0813
72558297|NCT02554877|144645934|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|1.39|STANDARD_ERROR_OF_MEAN|0.45||0.0024|TWO_SIDED|90.0|0.65|2.14||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 12. The readings with residual greater than 3.5 times of its standard derivation were excluded from the presentation.(Excluding outliers)||2.14|0.65|0.0024
72558298|NCT02554877|144645934|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|1.15|STANDARD_ERROR_OF_MEAN|0.45||0.0115|TWO_SIDED|90.0|0.4|1.89||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 12. The readings with residual greater than 3.5 times of its standard derivation were excluded from the presentation.(Excluding outliers)||1.89|0.40|0.0115
72436294|NCT00758602|144385766|SUPERIORITY_OR_OTHER||LS Mean difference|-1.5977||||0.7949|TWO_SIDED|95.0|-13.77|10.58||p-value, LS mean difference, and 95% CI based on ANCOVA model with treatment, center, and the treatment-by-center interaction as fixed effects, and the donor age as a covariate.|ANCOVA|||||10.58|-13.77|0.7949
72436295|NCT00758602|144385767|SUPERIORITY_OR_OTHER|||||||0.6812|||||||Fisher Exact|||Acute rejection, 6 months post-transplant||||0.6812
72494532|NCT05064059|144518472|OTHER||Hazard Ratio (HR)|1.0||||0.5094|TWO_SIDED|95.0|0.64|1.58||One-sided p-value based on log-rank test stratified by geographic region (Asia Pacific; EMEA/Americas), presence of liver metastasis (Yes/No) and time from initial diagnosis of metastatic disease to randomization (\>=18 months, \<18 months).|Log Rank||HR and 95% CI were based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by geographic region, presence of liver metastasis \& time from initial diagnosis of metastatic disease to randomization.|||1.58|0.64|0.5094
72494533|NCT05064059|144518473|OTHER||Hazard Ratio (HR)|1.51||||0.9704|TWO_SIDED|95.0|0.98|2.33||One-sided p-value based on log-rank test stratified by geographic region (Asia Pacific; EMEA/Americas), presence of liver metastasis (Yes/No) and time from initial diagnosis of metastatic disease to randomization (\>=18 months, \<18 months).|Log Rank||HR and 95% CI were based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by geographic region, presence of liver metastasis \& time from initial diagnosis of metastatic disease to randomization.|||2.33|0.98|0.9704
72494534|NCT05064059|144518474|OTHER||Hazard Ratio (HR)|1.82||||0.9905|TWO_SIDED|95.0|1.11|2.98||One-sided p-value based on log-rank test stratified by geographic region (Asia Pacific; EMEA/Americas), presence of liver metastasis (Yes/No) and time from initial diagnosis of metastatic disease to randomization (\>=18 months, \<18 months).|Log Rank||HR and 95% CI were based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by geographic region, presence of liver metastasis \& time from initial diagnosis of metastatic disease to randomization.|||2.98|1.11|0.9905
72494535|NCT05064059|144518475|OTHER||Hazard Ratio (HR)|1.86||||0.9853|TWO_SIDED|95.0|1.06|3.26||One-sided p-value based on log-rank test stratified by geographic region (Asia Pacific; EMEA/Americas), presence of liver metastasis (Yes/No) and time from initial diagnosis of metastatic disease to randomization (\>=18 months, \<18 months).|Log Rank||HR and 95% CI were based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by geographic region, presence of liver metastasis \& time from initial diagnosis of metastatic disease to randomization|||3.26|1.06|0.9853
72494536|NCT00805740|144518497|SUPERIORITY_OR_OTHER||Risk Difference (RD)|21.8|||||TWO_SIDED|95.0|-12.3|53.3||||||The 95 percent (%) confidence interval (CI) was calculated using method of exact unconditional confidence limits for the difference. Global response (rates of success) by using a 2-sided 95% CI for the true difference in efficacy (Anidulafungin minus Caspofungin) was calculated. Statistical testing was done at 2.5% alpha.||53.3|-12.3|
72494537|NCT00805740|144518498|SUPERIORITY_OR_OTHER||Risk Difference (RD)|21.6|||||TWO_SIDED|95.0|-13.6|55.6||||||2-week follow-up: The 95% CI was calculated using method of exact unconditional confidence limits for the difference. Global response (rates of success) by using a 2-sided 95% CI for the true difference in efficacy (Anidulafungin minus Caspofungin) was calculated. Statistical testing was done at 2.5% alpha.||55.6|-13.6|
72494538|NCT00805740|144518498|SUPERIORITY_OR_OTHER||Risk Difference (RD)|12.1|||||TWO_SIDED|95.0|-23.3|47.3||||||6-week follow-up: The 95% CI was calculated using method of exact unconditional confidence limits for the difference. Global response (rates of success) by using a 2-sided 95% CI for the true difference in efficacy (Anidulafungin minus Caspofungin) was calculated. Statistical testing was done at 2.5% alpha.||47.3|-23.3|
72494539|NCT00805740|144518500|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-6.1|||||TWO_SIDED|95.0|-39.0|27.9||||||The 95% CI was calculated using method of exact unconditional confidence limits for the difference. Global response (rates of success) by using a 2-sided 95% CI for the true difference in efficacy (Anidulafungin minus Caspofungin) was calculated. Statistical testing was done at 2.5% alpha.||27.9|-39.0|
72494540|NCT00353418|144518569|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.15||||0.6119||95.0|0.68|1.93|||Cochran-Mantel-Haenszel|||"Sample sizes of 133 and 267 patients for RBV 800 mg daily and RBV 1000 or 1200 mg daily, respectively, provided the following probabilities of detecting the specified differences in SVR with a 0.05 level two-sided chi-square test of significance:~RBV 800 mg SVR - 0.30; RBV 1000 or 1200 mg SVR - 0.40; Probability - 0.49~RBV 800 mg SVR - 0.30; RBV 1000 or 1200 mg SVR - 0.45; Probability - 0.83"||1.93|0.68|0.6119
72494541|NCT00608985|144518585|SUPERIORITY_OR_OTHER||Median Difference (Net)|-15.0|||<|0.0001|TWO_SIDED|95.0|-21.8|-8.8|||Wilcoxon rank-sum|||Change from baseline to day 1\&2 compared with placebo||-8.8|-21.8|<0.0001
72436296|NCT00758602|144385767|SUPERIORITY_OR_OTHER|||||||0.6812|||||||Fisher Exact|||Acute rejection, 12 months post-transplant||||0.6812
72436297|NCT00758602|144385767|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||Death, 12 months post-transplant||||1.0000
72436298|NCT00758602|144385769|SUPERIORITY_OR_OTHER|||||||1|||||||Log Rank|||||||1.0000
72436299|NCT00758602|144385770|SUPERIORITY_OR_OTHER|||||||0.4586|||||||Fisher Exact|||||||0.4586
72436300|NCT00758602|144385771|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||||||1.0000
72436301|NCT02371746|144385781|SUPERIORITY||Change from baseline|30.4|STANDARD_DEVIATION|1.84|<|0.001|TWO_SIDED|95.0|-1.8|36.6|||ANCOVA|||estimatCohort 1 all Groups: Non-study eye: TRAVANTAN Z Cohort 1 - Group 1: Study Eye: 28.2 ug travoprost Cohort 1 - Group 2: Study Eye: 42.3 ug travoprost Cohort 1 - Group 3: Study Eye: 42 .5 ug travoprost Cohort 1 - Group 4: Study Eye: 85.0 ug travoprost||36.6|-1.8|<0.001
72436302|NCT01157182|144385782|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|102.94|||||TWO_SIDED|90.0|97.63|108.55|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||108.55|97.63|
72436303|NCT01157182|144385783|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|98.4|||||TWO_SIDED|90.0|95.15|101.76|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||101.76|95.15|
72384257|NCT02979197|144276253|SUPERIORITY|||||||0.0005|||||||ANCOVA|Adjusted mean = -3.48 μmol/L; 95% confidence interval = -5.4 to -1.6||Renal function was analyzed by evaluating the decreases in serum creatinine from baseline to Day 14 for each treatment arm and between treatment arms by ANCOVA. This analysis was for the Amlodipine+Celecoxib arm from baseline to Day 14.||||0.0005
72384258|NCT02979197|144276253|SUPERIORITY|||||||0.075|||||||ANCOVA|Adjusted mean = -1.72 μmol/L; 95% confidence interval = -3.6 to 0.2||Renal function was analyzed by evaluating the decreases in serum creatinine from baseline to Day 14 for each treatment arm and between treatment arms by ANCOVA. This analysis was for the Amlodipine+Placebo arm from baseline to Day 14.||||0.0750
72384259|NCT02979197|144276253|SUPERIORITY|||||||0.4184|||||||ANCOVA|Adjusted mean = -1.92 μmol/L; 95% confidence interval = -6.6 to 2.8||Renal function was analyzed by evaluating the decreases in serum creatinine from baseline to Day 14 for each treatment arm and between treatment arms by ANCOVA. This analysis was for the Placebo+Placebo arm from baseline to Day 14.||||0.4184
72384260|NCT02979197|144276253|SUPERIORITY|||||||0.2022|||||||ANCOVA|Adjusted mean = -1.76 μmol/L; 95% confidence interval = -4.5 to 1.0||Renal function was analyzed by evaluating the decreases in serum creatinine from baseline to Day 14 for each treatment arm and between treatment arms by ANCOVA. This analysis was for the comparison between the Amlodipine+Celecoxib and Amlodipine+Placebo arms.||||0.2022
72384261|NCT02979197|144276253|SUPERIORITY|||||||0.541|||||||ANCOVA|Adjusted mean = -1.56 μmol/L; 95% confidence interval = -6.6 to 3.5||Renal function was analyzed by evaluating the decreases in serum creatinine from baseline to Day 14 for each treatment arm and between treatment arms by ANCOVA. This analysis was for the comparison between the Amlodipine+Celecoxib and Placebo+Placebo arms.||||0.5410
72384262|NCT02979197|144276253|SUPERIORITY|||||||0.9397|||||||ANCOVA|Adjusted mean = 0.19 μmol/L; 95% confidence interval = -4.9 to 5.2||Renal function was analyzed by evaluating the decreases in serum creatinine from baseline to Day 14 for each treatment arm and between treatment arms by ANCOVA. This analysis was for the comparison between the Amlodipine+Placebo and Placebo+Placebo arms.||||0.9397
72384263|NCT03438383|144276256|SUPERIORITY|We computed (post-hoc) the observed power of the performed tests (ANOVA for repeated measures). We confirmed that the specific sample size, as calculated using the Do-it-Yourself (DiY) sample size calculator (online at: https://blog.exmr.net/ sample-size-calculator) by considering a confidence level of 95% and a 10% margin of error, yielded adequate statistical power (\> 80%) for each of the examined variables.||||||0.88||||||The a priori threshold for statistical significance was set at \<0.05|ANOVA|||24 h before surgery (pre-operative or baseline values)||||0.88
72384264|NCT03438383|144276256|SUPERIORITY|We computed (post-hoc) the observed power of the performed tests (ANOVA for repeated measures). We confirmed that the specific sample size, as calculated using the Do-it-Yourself (DiY) sample size calculator (online at: https://blog.exmr.net/ sample-size-calculator) by considering a confidence level of 95% and a 10% margin of error, yielded adequate statistical power (\> 80%) for each of the examined variables.||||||0.23||||||The a priori threshold for statistical significance was set at \<0.05|ANOVA|||24 h post-operatively||||0.23
72384265|NCT03438383|144276256|SUPERIORITY|We checked for equivalence of the pre-op (baseline) values between the two groups. We computed (post-hoc) the observed power of the performed tests (ANOVA for repeated measures). We confirmed that the specific sample size, as calculated using the Do-it-Yourself (DiY) sample size calculator (online at: https://blog.exmr.net/ sample-size-calculator) by considering a confidence level of 95% and a 10% margin of error, yielded adequate statistical power (\> 80%) for each of the examined variables.||||||0.008||||||The a priori threshold for statistical significance was set at \<0.05|ANOVA|||48 hours post-operatively||||0.008
72384266|NCT03438383|144276256|SUPERIORITY|We checked for equivalence of the pre-op (baseline) values between the two groups. We computed (post-hoc) the observed power of the performed tests (ANOVA for repeated measures). We confirmed that the specific sample size, as calculated using the Do-it-Yourself (DiY) sample size calculator (online at: https://blog.exmr.net/ sample-size-calculator) by considering a confidence level of 95% and a 10% margin of error, yielded adequate statistical power (\> 80%) for each of the examined variables.||||||0.001||||||The a priori threshold for statistical significance was set at \<0.05|ANOVA|||72 h post-operatively||||0.001
72384267|NCT03438383|144276257|SUPERIORITY|We computed (post-hoc) the observed power of the performed tests (ANOVA for repeated measures). We confirmed that the specific sample size, as calculated using the Do-it-Yourself (DiY) quantitative research sample size calculator (available online at: https://blog.exmr.net/ sample-size-calculator) by considering a confidence level of 95% and a 10% margin of error, yielded adequate statistical power (\> 80%) for each of the examined variables.||||||0.75||||||The a priori threshold for statistical significance was set at \<0.05|ANOVA|||24 h before surgery (pre-operative or baseline values)||||0.75
72384268|NCT03438383|144276257|SUPERIORITY|We computed (post-hoc) the observed power of the performed tests (ANOVA for repeated measures). We confirmed that the specific sample size, as calculated using the Do-it-Yourself (DiY) sample size calculator (online at: https://blog.exmr.net/ sample-size-calculator) by considering a confidence level of 95% and a 10% margin of error, yielded adequate statistical power (\> 80%) for each of the examined variables.||||||0.09||||||The a priori threshold for statistical significance was set at \<0.05|ANOVA|||24 h post-operatively||||0.09
72436304|NCT01157182|144385784|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|98.73|||||TWO_SIDED|90.0|95.33|102.26|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||102.26|95.33|
72436305|NCT01157182|144385785|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|92.51|||||TWO_SIDED|90.0|88.64|96.55|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||96.55|88.64|
72494542|NCT00608985|144518585|SUPERIORITY_OR_OTHER||Median Difference (Net)|-26.8|||<|0.0001|TWO_SIDED|95.0|-34.3|-19.5|||Wilcoxon rank-sum|||Change from baseline to day 1\&2 compared with placebo||-19.5|-34.3|<0.0001
72494543|NCT00608985|144518585|SUPERIORITY_OR_OTHER||Median Difference (Net)|-6.8||||0.0376|TWO_SIDED|95.0|-13.5|-0.3|||Wilcoxon rank-sum|||Change from baseline to day 1\&2 compared with placebo||-0.3|-13.5|0.0376
72494544|NCT00608985|144518586|SUPERIORITY_OR_OTHER||Median Difference (Net)|-13.5||||0.0001|TWO_SIDED|95.0|-20.3|-6.5|||Wilcoxon rank-sum|||Change from baseline to day 15\&16 compared with placebo||-6.5|-20.3|0.0001
72558299|NCT02554877|144645934|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|0.97|STANDARD_ERROR_OF_MEAN|0.45||0.0344|TWO_SIDED|90.0|0.22|1.72||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 12. The readings with residual greater than 3.5 times of its standard derivation were excluded from the presentation.(Excluding outliers)||1.72|0.22|0.0344
72384269|NCT03438383|144276257|SUPERIORITY|We computed (post-hoc) the observed power of the performed tests (ANOVA for repeated measures). We confirmed that the specific sample size, as calculated using the Do-it-Yourself (DiY) sample size calculator (online at: https://blog.exmr.net/ sample-size-calculator) by considering a confidence level of 95% and a 10% margin of error, yielded adequate statistical power (\> 80%) for each of the examined variables.||||||0.008||||||The a priori threshold for statistical significance was set at \<0.05|ANOVA|||48 h post-operatively||||0.008
72384270|NCT03438383|144276257|SUPERIORITY|We computed (post-hoc) the observed power of the performed tests (ANOVA for repeated measures). We confirmed that the specific sample size, as calculated using the Do-it-Yourself (DiY) sample size calculator (online at: https://blog.exmr.net/ sample-size-calculator) by considering a confidence level of 95% and a 10% margin of error, yielded adequate statistical power (\> 80%) for each of the examined variables.||||||0.013||||||The a priori threshold for statistical significance was set at \<0.05|ANOVA|||72 h post-operatively||||0.013
72384271|NCT03438383|144276258|SUPERIORITY|We computed (post-hoc) the observed power of the performed tests (ANOVA for repeated measures). We confirmed that the specific sample size, as calculated using the Do-it-Yourself (DiY) quantitative research sample size calculator (available online at: https://blog.exmr.net/ sample-size-calculator) by considering a confidence level of 95% and a 10% margin of error, yielded adequate statistical power (\> 80%) for each of the examined variables.||||||0.05||||||The a priori threshold for statistical significance was set at \<0.05|ANOVA|||24 h before surgery (pre-operative or baseline values)||||0.05
72384272|NCT03438383|144276258|SUPERIORITY|We computed (post-hoc) the observed power of the performed tests (ANOVA for repeated measures). We confirmed that the specific sample size, as calculated using the Do-it-Yourself (DiY) sample size calculator (online at: https://blog.exmr.net/ sample-size-calculator) by considering a confidence level of 95% and a 10% margin of error, yielded adequate statistical power (\> 80%) for each of the examined variables.||||||0.55||||||The a priori threshold for statistical significance was set at \<0.05|ANOVA|||24 h post-operatively||||0.55
72384273|NCT03438383|144276258|SUPERIORITY|We computed (post-hoc) the observed power of the performed tests (ANOVA for repeated measures). We confirmed that the specific sample size, as calculated using the Do-it-Yourself (DiY) sample size calculator (online at: https://blog.exmr.net/ sample-size-calculator) by considering a confidence level of 95% and a 10% margin of error, yielded adequate statistical power (\> 80%) for each of the examined variables.||||||0.13||||||The a priori threshold for statistical significance was set at \<0.05|ANOVA|||48h post-operatively||||0.13
72384274|NCT03438383|144276258|SUPERIORITY|We computed (post-hoc) the observed power of the performed tests (ANOVA for repeated measures). We confirmed that the specific sample size, as calculated using the Do-it-Yourself (DiY) sample size calculator (online at: https://blog.exmr.net/ sample-size-calculator) by considering a confidence level of 95% and a 10% margin of error, yielded adequate statistical power (\> 80%) for each of the examined variables.||||||0.011||||||The a priori threshold for statistical significance was set at \<0.05|ANOVA|||72 h post-operatively||||0.011
72494545|NCT00608985|144518586|SUPERIORITY_OR_OTHER||Median Difference (Net)|-19.5|||<|0.0001|TWO_SIDED|95.0|-27.3|-12.3|||Wilcoxon rank-sum|||Change from baseline to day 15\&16 compared with placebo||-12.3|-27.3|<0.0001
72494546|NCT00608985|144518586|SUPERIORITY_OR_OTHER||Median Difference (Net)|3.5||||0.3358|TWO_SIDED|95.0|-3.8|11.0|||Wilcoxon rank-sum|||Change from baseline to day 15\&16 compared with placebo||11.0|-3.8|0.3358
72494547|NCT00608985|144518587|SUPERIORITY_OR_OTHER||Median Difference (Net)|-7.3||||0.0186|TWO_SIDED|95.0|-13.3|-1.3|||Wilcoxon rank-sum|||Change from baseline to week 1\&2 compared with placebo||-1.3|-13.3|0.0186
72558300|NCT04547192|144645951|SUPERIORITY|Power calculation - Expected enrollment: 25 patients/hospital/month, giving a total of 3,500 patients across all hospitals over 17.5 months. With an alpha of 0.05 and baseline TIF adherence rate of 50%, there was 80% power to detect 8.1-8.6% difference in KPI performance with 0.15-0.40 range in COV.|Odds Ratio (OR)|1.54||||0.504|TWO_SIDED|||||Adjusted for TIF introduction and time periods as fixed effects and hospitals and time periods as random effects.|generalized linear mixed regression mode|||For mobility on EU arrival assessed,||||0.504
72494548|NCT00608985|144518587|SUPERIORITY_OR_OTHER||Median Difference (Net)|-10.4||||0.0006|TWO_SIDED|95.0|-16.4|-4.6|||Wilcoxon rank-sum|||Change from baseline to week 1\&2 compared with placebo||-4.6|-16.4|0.0006
72494549|NCT00608985|144518587|SUPERIORITY_OR_OTHER||Median Difference (Net)|-12.7|||<|0.0001|TWO_SIDED|95.0|-18.8|-6.6|||Wilcoxon rank-sum|||Change from baseline to week 1\&2 compared with placebo||-6.6|-18.8|<0.0001
72494550|NCT00608985|144518588|SUPERIORITY_OR_OTHER||Median Difference (Net)|-9.3||||0.0035|TWO_SIDED|95.0|-15.3|-3.0|||Wilcoxon rank-sum|||Change from baseline to day 1\&2 compared with placebo||-3.0|-15.3|0.0035
72494551|NCT00608985|144518588|SUPERIORITY_OR_OTHER||Median Difference (Net)|-9.5||||0.0006|TWO_SIDED|95.0|-15.0|-4.3|||Wilcoxon rank-sum|||Change from baseline to day 1\&2 compared with placebo||-4.3|-15.0|0.0006
72384275|NCT03438383|144276259|SUPERIORITY|We computed (post-hoc) the observed power of the performed tests (ANOVA for repeated measures). We confirmed that the specific sample size, as calculated using the Do-it-Yourself (DiY) quantitative research sample size calculator (available online at: https://blog.exmr.net/ sample-size-calculator) by considering a confidence level of 95% and a 10% margin of error, yielded adequate statistical power (\> 80%) for each of the examined variables.||||||0.83||||||The a priori threshold for statistical significance was set at \<0.05|ANOVA|||24 h before surgery (pre-operative or baseline values)||||0.83
72384276|NCT03438383|144276259|SUPERIORITY|We computed (post-hoc) the observed power of the performed tests (ANOVA for repeated measures). We confirmed that the specific sample size, as calculated using the Do-it-Yourself (DiY) sample size calculator (online at: https://blog.exmr.net/ sample-size-calculator) by considering a confidence level of 95% and a 10% margin of error, yielded adequate statistical power (\> 80%) for each of the examined variables.||||||0.37||||||The a priori threshold for statistical significance was set at \<0.05|ANOVA|||24 h post-operatively||||0.37
72384277|NCT03438383|144276259|SUPERIORITY|We computed (post-hoc) the observed power of the performed tests (ANOVA for repeated measures). We confirmed that the specific sample size, as calculated using the Do-it-Yourself (DiY) sample size calculator (online at: https://blog.exmr.net/ sample-size-calculator) by considering a confidence level of 95% and a 10% margin of error, yielded adequate statistical power (\> 80%) for each of the examined variables.||||||0.0035||||||The a priori threshold for statistical significance was set at \<0.05|ANOVA|||48 h post-operatively||||0.0035
72384278|NCT03438383|144276259|SUPERIORITY|We computed (post-hoc) the observed power of the performed tests (ANOVA for repeated measures). We confirmed that the specific sample size, as calculated using the Do-it-Yourself (DiY) sample size calculator (online at: https://blog.exmr.net/ sample-size-calculator) by considering a confidence level of 95% and a 10% margin of error, yielded adequate statistical power (\> 80%) for each of the examined variables.||||||1.5e-05||||||The a priori threshold for statistical significance was set at \<0.05|ANOVA|||72 h post-operatively||||0.000015
72384279|NCT02766465|144276265|SUPERIORITY||||||<|0.001||||||Statistical significance was determined using a pre-specified threshold of 0.05|Wilcoxon (Mann-Whitney)|||This is the result comparing severe vaso-occlusive pain (VOC) with hospitalization or parenteral opioid drugs in outpatient setting between two biologically assigned arms during the first year after biologic assignment. The null hypothesis is that there is no difference in biologically assigned arms during the first year after assignment.||||<0.001
72384280|NCT02766465|144276265|SUPERIORITY|||||||0.027||||||Statistical significance was determined using a pre-specified threshold of 0.05|Wilcoxon (Mann-Whitney)|||This is the result comparing significant cerebrovascular event between two biologically assigned arms during the first year after biologic assignment. Significant cerebrovascular event includes stroke, transient ischemic attack, and seizure. The null hypothesis is that there is no difference in biologically assigned arms during the first year after assignment.||||0.027
72384281|NCT02766465|144276265|SUPERIORITY||||||<|0.001||||||Statistical significance was determined using a pre-specified threshold of 0.05|Wilcoxon (Mann-Whitney)|||This is the result comparing severe Vaso-occlusive pain (VOC) with hospitalization or parenteral opioid drugs in outpatient setting between two biologically assigned arms during the second year after biologic assignment. The null hypothesis is that there is no difference in biologically assigned arms during the second year after assignment.||||< 0.001
72384282|NCT02766465|144276266|SUPERIORITY|||||||0.869||||||Statistical significance was determined using a pre-specified threshold of 0.05|Wilcoxon (Mann-Whitney)|||This is the result comparing 6MWD from 2 years after biologic assignment to baseline between two biologically assigned arms. The null hypothesis is that there is no difference between biologically assigned arms||||0.869
72384283|NCT02766465|144276267|SUPERIORITY|||||||0.636||||||Statistical significance was determined using a pre-specified threshold of 0.05|Wilcoxon (Mann-Whitney)|||This is the result comparing TRJV from 2 years after biologic assignment to baseline between two biologically assigned arms. The null hypothesis is that there is no difference between biologically assigned arms||||0.636
72384284|NCT02766465|144276269|SUPERIORITY|||||||0.242||||||Statistical significance was determined using a pre-specified threshold of 0.05|Wilcoxon (Mann-Whitney)|||This is the result comparing Physical Function changes from 2 years after biologic assignment to baseline between two biologically assigned arms. The null hypothesis is that there is no difference between biologically assigned arms||||0.242
72384285|NCT02766465|144276270|SUPERIORITY|||||||0.343||||||Statistical significance was determined using a pre-specified threshold of 0.05|Wilcoxon (Mann-Whitney)|||This is the result comparing Anxiety changes from 2 years after biologic assignment to baseline between two biologically assigned arms. The null hypothesis is that there is no difference between biologically assigned arms||||0.343
72384286|NCT02766465|144276271|SUPERIORITY|||||||0.491||||||Statistical significance was determined using a pre-specified threshold of 0.05|Wilcoxon (Mann-Whitney)|||This is the result comparing Depression changes from 2 years after biologic assignment to baseline between two biologically assigned arms. The null hypothesis is that there is no difference between biologically assigned arms||||0.491
72384287|NCT02766465|144276272|SUPERIORITY|||||||0.003||||||Statistical significance was determined using a pre-specified threshold of 0.05|Wilcoxon (Mann-Whitney)|||This is the result comparing fatigue score changes from 2 years after biologic assignment to baseline between two biologically assigned arms. The null hypothesis is that there is no difference between biologically assigned arms||||0.003
72558301|NCT04547192|144645951|SUPERIORITY|Power calculation - Expected enrollment: 25 patients/hospital/month, giving a total of 3,500 patients across all hospitals over 17.5 months. With an alpha of 0.05 and baseline TIF adherence rate of 50%, there was 80% power to detect 8.1-8.6% difference in KPI performance with 0.15-0.40 range in COV.|Odds Ratio (OR)|2.31||||0.169|TWO_SIDED||||||generalized linear mixed regression mode|||Respiratory rate at EU assessed||||0.169
72384288|NCT02766465|144276273|SUPERIORITY|||||||0.594||||||Statistical significance was determined using a pre-specified threshold of 0.05|Wilcoxon (Mann-Whitney)|||This is the result comparing Sleep Disturbance changes from 2 years after biologic assignment to baseline between two biologically assigned arms. The null hypothesis is that there is no difference between biologically assigned arms||||0.594
72494552|NCT00608985|144518588|SUPERIORITY_OR_OTHER||Median Difference (Net)|-16.0|||<|0.0001|TWO_SIDED|95.0|-22.0|-9.8|||Wilcoxon rank-sum|||Change from baseline to day 1\&2 compared with placebo||-9.8|-22.0|<0.0001
72436306|NCT01157182|144385786|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|95.66|||||TWO_SIDED|90.0|92.6|98.81|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||98.81|92.60|
72436307|NCT01157182|144385787|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|95.71|||||TWO_SIDED|90.0|92.62|98.91|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||98.91|92.62|
72436308|NCT01157182|144385788|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|92.41|||||TWO_SIDED|90.0|88.65|96.33|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||96.33|88.65|
72436309|NCT01157182|144385789|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|95.67|||||TWO_SIDED|90.0|92.68|98.77|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||98.77|92.68|
72494553|NCT00608985|144518589|SUPERIORITY_OR_OTHER||Median Difference (Net)|-4.0||||0.2237|TWO_SIDED|95.0|-11.0|2.5|||Wilcoxon rank-sum|||Change from baseline to day 15\&16 compared with placebo||2.5|-11.0|0.2237
72494554|NCT00608985|144518589|SUPERIORITY_OR_OTHER||Median Difference (Net)|-6.0||||0.0607|TWO_SIDED|95.0|-12.3|0.3|||Wilcoxon rank-sum|||Change from baseline to day 15\&16 compared with placebo||0.3|-12.3|0.0607
72494555|NCT00608985|144518589|SUPERIORITY_OR_OTHER||Median Difference (Net)|-10.5||||0.0017|TWO_SIDED|95.0|-17.3|-4.0|||Wilcoxon rank-sum|||Change from baseline to day 15\&16 compared with placebo||-4.0|-17.3|0.0017
72494556|NCT00608985|144518590|SUPERIORITY_OR_OTHER||Median Difference (Net)|-4.1||||0.1187|TWO_SIDED|95.0|-9.1|0.9|||Wilcoxon rank-sum|||Change from baseline to week 1\&2 compared with placebo||0.9|-9.1|0.1187
72494557|NCT00608985|144518590|SUPERIORITY_OR_OTHER||Median Difference (Net)|-7.1||||0.0017|TWO_SIDED|95.0|-11.5|-2.7|||Wilcoxon rank-sum|||Change from baseline to week 1\&2 compared with placebo||-2.7|-11.5|0.0017
72494558|NCT00608985|144518590|SUPERIORITY_OR_OTHER||Median Difference (Net)|-6.1||||0.0121|TWO_SIDED|95.0|-10.8|-1.4|||Wilcoxon rank-sum|||Change from baseline to week 1\&2 compared with placebo||-1.4|-10.8|0.0121
72494559|NCT00662792|144518615|SUPERIORITY||Difference of adjusted means|0.13|STANDARD_ERROR_OF_MEAN|0.014|<|0.0001|TWO_SIDED|95.0|0.102|0.158|||ANOVA|Analysis of variance with terms for centre, patient with centre, treatment, and period.|(T+S\_PE) - (Salm50DPI)|H1: Superiority of FDC Tiotropium/Salmeterol (T+S\_PE) vs. salmeterol (Salm50DPI) for FEV1 AUC0-12||0.158|0.102|<0.0001
72558302|NCT04547192|144645951|SUPERIORITY|Power calculation - Expected enrollment: 25 patients/hospital/month, giving a total of 3,500 patients across all hospitals over 17.5 months. With an alpha of 0.05 and baseline TIF adherence rate of 50%, there was 80% power to detect 8.1-8.6% difference in KPI performance with 0.15-0.40 range in COV.|Odds Ratio (OR)|25.29||||0.006|TWO_SIDED||||||generalized linear mixed regression|||Airway assessed||||0.006
72494560|NCT00662792|144518615|SUPERIORITY||Difference of adjusted means|0.07|STANDARD_ERROR_OF_MEAN|0.014|<|0.0001|TWO_SIDED|95.0|0.042|0.097|||ANOVA|"Analysis of variance with terms for centre, patient with centre, treatment, and period.~α = 0.025 one-sided"|(T+S\_PE) - (Tio18GEL)|H1: Superiority of FDC Tiotropium/Salmeterol (T+S\_PE) vs Tiotropium (Tio18GEL) for FEV1 AUC0- 12||0.097|0.042|<.0001
72494561|NCT00662792|144518615|OTHER||Difference of adjusted means|-0.024|STANDARD_ERROR_OF_MEAN|0.014||0.0914|TWO_SIDED|95.0|-0.052|0.004|||ANOVA|Analysis of variance with terms for centre, patient with centre, treatment, and period. α = 0.025 one-sided|(T+S\_PE) - (T18GEL+S-DPI)|The Tiotropium free combination (T18GEL+S\_DPI) was included in order to characterise this treatment in comparison with the FDC Tiotropium/Salmeterol (T+S\_PE). No formal hypotheses were defined.||0.004|-0.052|0.0914
72494562|NCT00662792|144518616|NON_INFERIORITY|The non-inferiority margin for FEV1 endpoints was defined as d=0.050 L.|Difference of adjusted means|0.064|STANDARD_ERROR_OF_MEAN|0.015|<|0.0001|TWO_SIDED|95.0|0.036|0.093|||ANOVA|"Analysis of variance with terms for centre, patient with centre, treatment, and period.~α = 0.025 one-sided"|(T+S\_PE) - (Salm50DPI)|H1: Non-Inferiority of FDC Tiotropium/Salmeterol (T+S\_PE) vs. Salmeterol (Salm50DPI) for FEV1AUC12-24||0.093|0.036|<.0001
72494563|NCT00662792|144518616|NON_INFERIORITY|The non-inferiority margin for FEV1 endpoints was defined as d=0.050 L.|Difference of adjusted means|0.064|STANDARD_ERROR_OF_MEAN|0.015|<|0.0001|TWO_SIDED|95.0|0.036|0.093|||ANOVA|"Analysis of variance with terms for centre, patient with centre, treatment, and period.~α = 0.025 one-sided"|(T+S\_PE) - (Tio18GEL)|H1: Non-inferiority of FDC Tiotropium/Salmeterol (T+S\_PE) vs. Tiotropium (TIO18GEL) of FEV1AUC12-24||0.093|0.036|<.0001
72494564|NCT00662792|144518616|OTHER||Difference of adjusted means|-0.057|STANDARD_ERROR_OF_MEAN|0.015||0.0001|TWO_SIDED|95.0|-0.086|-0.028|||ANOVA|"Analysis of variance with terms for centre, patient with centre, treatment, and period.~α = 0.025 one-sided"|(T+S\_PE) - (T18GEL+S-DPI)|The Tiotropium free combination (T18GEL+S\_DPI) was included in order to characterise this treatment in comparison with the FDC Tiotropium/Salmeterol (T+S\_PE). No formal hypotheses were defined.||-0.028|-0.086|0.0001
72494565|NCT00662792|144518617|SUPERIORITY||Difference of adjusted means|0.134|STANDARD_ERROR_OF_MEAN|0.016|<|0.0001|TWO_SIDED|95.0|0.102|0.166|||ANOVA|"Analysis of variance with terms for centre, patient with centre, treatment, and period.~α = 0.025 one-sided"|(T+S\_PE) - (Salm50DPI)|H1: Superiority of FDC Tiotropium/Salmeterol (T+S\_PE) vs. Salmeterol (Salm50DPI) of Peak FEV1||0.166|0.102|<.0001
72494566|NCT00662792|144518617|SUPERIORITY||Difference of adjusted means|0.066|STANDARD_ERROR_OF_MEAN|0.016|<|0.0001|TWO_SIDED|95.0|0.034|0.098|||ANOVA|Analysis of with terms for centre, patient with centre, treatment, and period. α = 0.025 one-sided|(T+S\_PE) - (Tio18GEL)|H1: Superiority of FDC Tiotropium/Salmeterol (T+S\_PE) vs. Tiotropium (TIO18GEL) of PeakFEV1.||0.098|0.034|<.0001
72494567|NCT00662792|144518617|OTHER||Difference of adjusted means|-0.026|STANDARD_ERROR_OF_MEAN|0.016||0.1093|TWO_SIDED|95.0|-0.058|0.006|||ANOVA|"Analysis of variance with terms for centre, patient with centre, treatment, and period.~α = 0.025 one-sided"|(T+S\_PE) - (T18GEL+S\_DPI)|The Tiotropium free combination (T18GEL+S\_DPI) was included in order to characterise this treatment in comparison with the FDC Tiotropium/Salmeterol (T+S\_PE). No formal hypotheses were defined.||0.006|-0.058|0.1093
72494568|NCT00662792|144518618|NON_INFERIORITY|The non-inferiority margin for FEV1 endpoints was defined as d=0.050 L.|Differences of adjusted means|0.058|STANDARD_ERROR_OF_MEAN|0.017||0.0008|TWO_SIDED|95.0|0.024|0.092|||ANOVA|"Analysis of variance with terms for centre, patient with centre, treatment, and period.~α = 0.025 one-sided"|(T+S\_PE) - (Salm50DPI)|H1: Non-inferiority of FDC Tiotropium/Salmeterol (T+S\_PE) vs. Salmeterol (Salm50DPI) of trough FEV1||0.092|0.024|0.0008
72494569|NCT00662792|144518618|NON_INFERIORITY|The non-inferiority margin for FEV1 endpoints was defined as a delta of 0.050 L.|Difference of adjusted means|0.029|STANDARD_ERROR_OF_MEAN|0.017||0.0857|TWO_SIDED|95.0|-0.004|0.063|||ANOVA|"Analysis of variance with terms for centre, patient with centre, treatment, and period.~α = 0.025 one-sided"|(T+S\_PE) - (Tio18GEL)|H1: Non-inferiority of FDC Tiotropium/Salmeterol (T+S\_PE) vs. Tiotropium (TIO18GEL) of trough FEV1||0.063|-0.004|0.0857
72494570|NCT00662792|144518618|OTHER||Difference of adjusted means|-0.037|STANDARD_ERROR_OF_MEAN|0.017||0.0317|TWO_SIDED|95.0|-0.071|-0.003|||ANOVA|"Analysis of variance with terms for centre, patient with centre, treatment, and period.~α = 0.025 one-sided"|(T+S\_PE) - (T18GEL+S-DPI)|The Tiotropium free combination (T18GEL+S\_DPI) was included in order to characterise this treatment in comparison with the FDC Tiotropium/Salmeterol (T+S\_PE). No formal hypotheses were defined.||-0.003|-0.071|0.0317
72494571|NCT00662792|144518619|SUPERIORITY||Difference of adjusted means|0.097|STANDARD_ERROR_OF_MEAN|0.014|<|0.0001|TWO_SIDED|95.0|0.071|0.124|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided|(T+S\_PE) - (Salm50DPI)|H1: Superiority of FDC Tiotropium/Salmeterol (T+S\_PE) vs. salmeterol (Salm50DPI) for FEV1 AUC0-24||0.124|0.071|<.0001
72494572|NCT00662792|144518619|SUPERIORITY||Difference of adjusted mean difference|0.067|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|0.041|0.093|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided|(T+S\_PE) - (Tio18GEL)|H1: Superiority of FDC Tiotropium/Salmeterol (T+S\_PE) vs. Tiotropium (TIO18GEL) for FEV1 AUC24||0.093|0.041|<.0001
72494573|NCT00662792|144518619|SUPERIORITY||Difference of adjusted means|-0.041|STANDARD_ERROR_OF_MEAN|0.014||0.0029|TWO_SIDED|95.0|-0.067|-0.014|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided|(T+S\_PE) - (T18GEL+S-DPI)|||-0.014|-0.067|0.0029
72494574|NCT00662792|144518620|SUPERIORITY||Difference of adjusted means|0.083|STANDARD_ERROR_OF_MEAN|0.025||0.001|TWO_SIDED|95.0|0.034|0.132|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided|(T+S\_PE) - (Tio18GEL)|||0.132|0.034|0.0010
72494575|NCT00662792|144518620|SUPERIORITY||Difference of adjusted means|0.176|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.127|0.226|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (Salm50DPI)|||0.226|0.127|<.0001
72494576|NCT00662792|144518620|SUPERIORITY||Difference of adjusted means|-0.045|STANDARD_ERROR_OF_MEAN|0.025||0.0757|TWO_SIDED|95.0|-0.095|0.005|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (T18GEL+S-DPI)|||0.005|-0.095|0.0757
72494577|NCT00662792|144518621|SUPERIORITY||Difference of adjusted means|0.085|STANDARD_ERROR_OF_MEAN|0.027||0.0015|TWO_SIDED|95.0|0.033|0.137|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (Tio18GEL)|||0.137|0.033|0.0015
72494578|NCT00662792|144518621|SUPERIORITY||Difference of adjusted means|0.118|STANDARD_ERROR_OF_MEAN|0.027|<|0.0001|TWO_SIDED|95.0|0.066|0.171|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (Salm50DPI)|||0.171|0.066|<.0001
72494579|NCT00662792|144518621|SUPERIORITY||Difference of adjusted means|-0.085|STANDARD_ERROR_OF_MEAN|0.027||0.0017|TWO_SIDED|95.0|-0.138|-0.032|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (T18GEL+S-DPI)|||-0.032|-0.138|0.0017
72494580|NCT00662792|144518622|SUPERIORITY||Difference of adjusted means|0.084|STANDARD_ERROR_OF_MEAN|0.024||0.0005|TWO_SIDED|95.0|0.037|0.131|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (Tio18GEL)|||0.131|0.037|0.0005
72494581|NCT00662792|144518622|SUPERIORITY||Difference of adjusted means|0.147|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001|TWO_SIDED|95.0|0.1|0.194|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (Salm50DPI)|||0.194|0.100|<.0001
72494582|NCT00662792|144518622|SUPERIORITY||Difference of adjusted means|-0.065|STANDARD_ERROR_OF_MEAN|0.024||0.0074|TWO_SIDED|95.0|-0.113|-0.018|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (T18GEL+S-DPI)|||-0.018|-0.113|0.0074
72494583|NCT00662792|144518623|SUPERIORITY||Differences of adjusted means|0.051|STANDARD_ERROR_OF_MEAN|0.03||0.0898|TWO_SIDED|95.0|-0.008|0.109|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (Tio18GEL)|||0.109|-0.008|0.0898
72494584|NCT00662792|144518623|SUPERIORITY||Difference of adjusted means|0.142|STANDARD_ERROR_OF_MEAN|0.03|<|0.0001|TWO_SIDED|95.0|0.083|0.201|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (Salm50DPI)|||0.201|0.083|<.0001
72494585|NCT00662792|144518623|SUPERIORITY||Difference of adjusted means|-0.057|STANDARD_ERROR_OF_MEAN|0.03||0.0601|TWO_SIDED|95.0|-0.116|0.002|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (T18GEL+S-DPI)|||0.002|-0.116|0.0601
72494586|NCT00662792|144518624|SUPERIORITY||Difference of adjusted means|-0.028|STANDARD_ERROR_OF_MEAN|0.031||0.3652|TWO_SIDED|95.0|-0.089|0.033|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (Tio18GEL)|||0.033|-0.089|0.3652
72384289|NCT02766465|144276274|SUPERIORITY|||||||0.003||||||Statistical significance was determined using a pre-specified threshold of 0.05|Wilcoxon (Mann-Whitney)|||This is the result comparing social roles score changes from 2 years after biologic assignment to baseline between two biologically assigned arms. The null hypothesis is that there is no difference between biologically assigned arms||||0.003
72384290|NCT02766465|144276275|SUPERIORITY|||||||0.071||||||Statistical significance was determined using a pre-specified threshold of 0.05|Wilcoxon (Mann-Whitney)|||This is the result comparing pain interference score changes from 2 years after biologic assignment to baseline between two biologically assigned arms. The null hypothesis is that there is no difference between biologically assigned arms||||0.071
72384291|NCT02766465|144276276|SUPERIORITY|||||||0.146||||||Statistical significance was determined using a pre-specified threshold of 0.05|Wilcoxon (Mann-Whitney)|||This is the result comparing Pain Intensity changes from 2 years after biologic assignment to baseline between two biologically assigned arms. The null hypothesis is that there is no difference between biologically assigned arms||||0.146
72384292|NCT02766465|144276277|SUPERIORITY|||||||0.649||||||Statistical significance was determined using a pre-specified threshold of 0.05|Wilcoxon (Mann-Whitney)|||This is the result comparing 28-Day Pain Diary Average Pain Intensity changes from 2 years after biologic assignment to baseline between two biologically assigned arms. The null hypothesis is that there is no difference between biologically assigned arms||||0.649
72384293|NCT02766465|144276278|SUPERIORITY|||||||0.207||||||Statistical significance was determined using a pre-specified threshold of 0.05|Wilcoxon (Mann-Whitney)|||This is the result comparing ASCQ-Me Stiffness changes from 2 years after biologic assignment to baseline between two biologically assigned arms. The null hypothesis is that there is no difference between biologically assigned arms||||0.207
72384294|NCT02766465|144276279|SUPERIORITY|||||||0.596||||||Statistical significance was determined using a pre-specified threshold of 0.05|Wilcoxon (Mann-Whitney)|||This is the result comparing FEV1 changes from 2 years after biologic assignment to baseline between two biologically assigned arms. The null hypothesis is that there is no difference between biologically assigned arms||||0.596
72384295|NCT02766465|144276280|SUPERIORITY|||||||0.684||||||Statistical significance was determined using a pre-specified threshold of 0.05|Wilcoxon (Mann-Whitney)|||This is the result comparing FVC changes from 2 years after biologic assignment to baseline between two biologically assigned arms. The null hypothesis is that there is no difference between biologically assigned arms||||0.684
72384296|NCT02766465|144276281|SUPERIORITY|||||||0.863||||||Statistical significance was determined using a pre-specified threshold of 0.05|Wilcoxon (Mann-Whitney)|||This is the result comparing FEV1/FVC changes from 2 years after biologic assignment to baseline between two biologically assigned arms. The null hypothesis is that there is no difference between biologically assigned arms||||0.863
72436310|NCT01157182|144385790|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|95.73|||||TWO_SIDED|90.0|92.68|98.88|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||98.88|92.68|
72436311|NCT01157182|144385791|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|91.21|||||TWO_SIDED|90.0|84.62|98.31|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||98.31|84.62|
72436312|NCT01157182|144385792|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|94.11|||||TWO_SIDED|90.0|89.04|99.47|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||99.47|89.04|
72436313|NCT01157182|144385793|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|97.48|||||TWO_SIDED|90.0|90.7|104.76|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||104.76|90.70|
72436314|NCT01157182|144385794|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|94.19|||||TWO_SIDED|90.0|89.78|98.81|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||98.81|89.78|
72494587|NCT00662792|144518624|SUPERIORITY||Difference of adjusted means|0.042|STANDARD_ERROR_OF_MEAN|0.031||0.1816|TWO_SIDED|95.0|-0.02|0.103|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (Salm50DPI)|||0.103|-0.020|0.1816
72558303|NCT04547192|144645951|SUPERIORITY|Power calculation - Expected enrollment: 25 patients/hospital/month, giving a total of 3,500 patients across all hospitals over 17.5 months. With an alpha of 0.05 and baseline TIF adherence rate of 50%, there was 80% power to detect 8.1-8.6% difference in KPI performance with 0.15-0.40 range in COV.|Odds Ratio (OR)|38.38||||0.001|TWO_SIDED||||||generalized linear mixed regression|||Chest examined||||0.001
72384297|NCT02766465|144276282|SUPERIORITY|||||||0.455||||||Statistical significance was determined using a pre-specified threshold of 0.05|Wilcoxon (Mann-Whitney)|||This is the result comparing VC changes from 2 years after biologic assignment to baseline between two biologically assigned arms. The null hypothesis is that there is no difference between biologically assigned arms||||0.455
72558304|NCT04547192|144645951|SUPERIORITY|Power calculation - Expected enrollment: 25 patients/hospital/month, giving a total of 3,500 patients across all hospitals over 17.5 months. With an alpha of 0.05 and baseline TIF adherence rate of 50%, there was 80% power to detect 8.1-8.6% difference in KPI performance with 0.15-0.40 range in COV.|Odds Ratio (OR)|93.01||||0.001|TWO_SIDED||||||generalized linear mixed regression|||For Intra-abdominal bleeding evaluated||||0.001
72436315|NCT01157182|144385795|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|95.99|||||TWO_SIDED|90.0|92.73|99.36|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||99.36|92.73|
72436316|NCT01157182|144385796|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|97.22|||||TWO_SIDED|90.0|93.62|100.96|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||100.96|93.62|
72436317|NCT01157182|144385797|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|91.73|||||TWO_SIDED|90.0|84.46|99.62|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||99.62|84.46|
72436318|NCT01157182|144385798|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|95.47|||||TWO_SIDED|90.0|88.37|103.14|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||103.14|88.37|
72436319|NCT01157182|144385799|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|95.63|||||TWO_SIDED|90.0|88.1|103.81|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||103.81|88.10|
72436320|NCT01157182|144385800|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|94.15|||||TWO_SIDED|90.0|89.56|98.98|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||98.98|89.56|
72494588|NCT00662792|144518624|SUPERIORITY||Difference of adjusted means|-0.095|STANDARD_ERROR_OF_MEAN|0.031||0.0026|TWO_SIDED|95.0|-0.157|-0.033|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (T18GEL+S-DPI)|||-0.033|-0.157|0.0026
72494589|NCT00662792|144518625|SUPERIORITY||Difference of adjusted means|11.8|STANDARD_ERROR_OF_MEAN|2.5|<|0.0001|TWO_SIDED|95.0|6.9|16.8|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (Tio18GEL)|||16.8|6.9|<.0001
72494590|NCT00662792|144518625|SUPERIORITY||Difference of adjusted means|24.2|STANDARD_ERROR_OF_MEAN|2.5|<|0.0001|TWO_SIDED|95.0|19.2|29.2|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (Salm50DPI)|||29.2|19.2|<.0001
72558305|NCT04547192|144645951|SUPERIORITY|Power calculation - Expected enrollment: 25 patients/hospital/month, giving a total of 3,500 patients across all hospitals over 17.5 months. With an alpha of 0.05 and baseline TIF adherence rate of 50%, there was 80% power to detect 8.1-8.6% difference in KPI performance with 0.15-0.40 range in COV.|Odds Ratio (OR)|354.91||||0.001|TWO_SIDED||||||generalized linear mixed regression|||For Spine Immobilized for RTI or Fall Victims||||0.001
72494591|NCT00662792|144518625|SUPERIORITY||Difference of adjusted means|-3.4|STANDARD_ERROR_OF_MEAN|2.6||0.1804|TWO_SIDED|95.0|-8.5|1.6|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (T18GEL+S-DPI)|||1.6|-8.5|0.1804
72558306|NCT04547192|144645951|SUPERIORITY|Power calculation - Expected enrollment: 25 patients/hospital/month, giving a total of 3,500 patients across all hospitals over 17.5 months. With an alpha of 0.05 and baseline TIF adherence rate of 50%, there was 80% power to detect 8.1-8.6% difference in KPI performance with 0.15-0.40 range in COV.|Odds Ratio (OR)|4.95||||0.001|TWO_SIDED||||||generalized linear mixed regression|||Splinting of Fractures Considered||||0.001
72494592|NCT00662792|144518626|SUPERIORITY||Difference of adjusted means|8.5|STANDARD_ERROR_OF_MEAN|2.5||0.0008|TWO_SIDED|95.0|3.5|13.4|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (Salm50DPI)|||13.4|3.5|0.0008
72494593|NCT00662792|144518626|SUPERIORITY||Difference of adjusted means|10.6|STANDARD_ERROR_OF_MEAN|2.5|<|0.0001|TWO_SIDED|95.0|5.6|15.5|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (Salm50DPI)|||15.5|5.6|<.0001
72494594|NCT00662792|144518626|SUPERIORITY||Difference of adjusted means|-12.9|STANDARD_ERROR_OF_MEAN|2.5|<|0.0001|TWO_SIDED|95.0|-17.9|-8.0|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (T18GEL+S\_DPI)|||-8.0|-17.9|<.0001
72494595|NCT00662792|144518627|SUPERIORITY||Difference of adjusted means|10.1|STANDARD_ERROR_OF_MEAN|2.3|<|0.0001|TWO_SIDED|95.0|5.7|14.6|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (Tio18GEL)|||14.6|5.7|<.0001
72384298|NCT02766465|144276283|SUPERIORITY|||||||0.767||||||Statistical significance was determined using a pre-specified threshold of 0.05|Wilcoxon (Mann-Whitney)|||This is the result comparing TLC changes from 2 years after biologic assignment to baseline between two biologically assigned arms. The null hypothesis is that there is no difference between biologically assigned arms||||0.767
72384299|NCT02766465|144276284|SUPERIORITY|||||||0.241||||||Statistical significance was determined using a pre-specified threshold of 0.05|Wilcoxon (Mann-Whitney)|||This is the result comparing RV changes from 2 years after biologic assignment to baseline between two biologically assigned arms. The null hypothesis is that there is no difference between biologically assigned arms||||0.241
72384300|NCT02766465|144276285|SUPERIORITY|||||||0.268||||||Statistical significance was determined using a pre-specified threshold of 0.05|Wilcoxon (Mann-Whitney)|||This is the result comparing ERV changes from 2 years after biologic assignment to baseline between two biologically assigned arms. The null hypothesis is that there is no difference between biologically assigned arms||||0.268
72384301|NCT02766465|144276286|SUPERIORITY||||||>|0.999||||||Statistical significance was determined using a pre-specified threshold of 0.05|Wilcoxon (Mann-Whitney)|||This is the result comparing IC changes from 2 years after biologic assignment to baseline between two biologically assigned arms. The null hypothesis is that there is no difference between biologically assigned arms||||>0.999
72384302|NCT02766465|144276287|SUPERIORITY|||||||0.832||||||Statistical significance was determined using a pre-specified threshold of 0.05|Wilcoxon (Mann-Whitney)|||This is the result comparing FRC changes from 2 years after biologic assignment to baseline between two biologically assigned arms. The null hypothesis is that there is no difference between biologically assigned arms||||0.832
72384303|NCT02766465|144276288|SUPERIORITY|||||||0.37||||||Statistical significance was determined using a pre-specified threshold of 0.05|Wilcoxon (Mann-Whitney)|||This is the result comparing DLCO changes from 2 years after biologic assignment to baseline between two biologically assigned arms. The null hypothesis is that there is no difference between biologically assigned arms||||0.370
72384304|NCT02766465|144276289|SUPERIORITY|||||||0.094||||||Statistical significance was determined using a pre-specified threshold of 0.05;|Wilcoxon (Mann-Whitney)|||This is the result comparing oxygen saturation changes from 2 years after biologic assignment to baseline between two biologically assigned arms. The null hypothesis is that there is no difference between biologically assigned arms||||0.094
72384305|NCT02766465|144276291|SUPERIORITY|||||||0.313||||||Statistical significance was determined using a pre-specified threshold of 0.05|Gray's test for cumulative Incidence|||The null hypothesis is that there is no difference of grade II-IV acute GVHD in patients who received different donor type at transplant||||0.313
72384306|NCT02766465|144276292|SUPERIORITY|||||||0.233||||||Statistical significance was determined using a pre-specified threshold of 0.05|Gray's test for cumulative Incidence|||The null hypothesis is that there is no difference of chronic GVHD in patients who received different donor type at transplant||||0.233
72384307|NCT02520661|144276297|SUPERIORITY||Odds Ratio (OR)|0.87|||||TWO_SIDED|95.0|0.62|1.22||||||treatment relevant change in number of ED visits by 14 days||1.22|0.62|
72384308|NCT02520661|144276297|SUPERIORITY||Odds Ratio (OR)|0.97|||||TWO_SIDED|95.0|0.72|1.3||||||treatment relevant change in number of ED visits by 30 days||1.30|0.72|
72384309|NCT02443519|144276318|SUPERIORITY||Slope|1.6||||0.027|TWO_SIDED|95.0|-0.7|3.9||Significance threshold set a priori at .025 to adjust for two co-primary outcomes.|Mixed Models Analysis|The key test was the Treatment (MBCT-M vs. WL.TAU) X Time (Month 1 vs 4) interaction with both Treatment and Time in the model.|A positive slope indicates greater reduction in the proportino of people with Severe MIDAS scores (Score \>=21) in the MBCT-M group vs. the WL/TAU group.|||3.9|-0.7|.027
72384310|NCT02443519|144276319|SUPERIORITY||Slope|14.1|||<|0.004|TWO_SIDED|95.0|0.8|21.8||Significance threshold set a priori at .025 to account for two co-primary outcomes.|Mixed Models Analysis|The key test was the Treatment (MBCT-M vs. WL.TAU) X Time (Month 1 vs 4) interaction with both Treatment and Time in the model.|Positive slope indicated larger reductions in HDI in the MBCT-M group compared to the WL/TAU group.|||21.8|0.8|<.004
72384311|NCT02443519|144276320|SUPERIORITY||Slope|-0.05||||0.773|TWO_SIDED|95.0|-3.7|2.8||Threshold for statistical significance set a priori at .05.|Mixed Models Analysis|Key test was the Treatment (MBCT-M vs. WL/TAU) X Time (Month 1 vs. 4) interaction with Treatment and Time in the model|A positive slope indicates greater reduction in headache days in the MBCT-M group vs. the WL/TAU group.|||2.8|-3.7|.773
72384312|NCT02443519|144276321|SUPERIORITY||Slope|0.01||||0.888|TWO_SIDED|95.0|-0.14|0.16||Threshold for significance set a priori at .05.|Mixed Models Analysis|The key test was the Treatment (MBCT-M vs. WL.TAU) X Time (Month 1 vs 4) interaction with both Treatment and Time in the model.|A positive slope indicates a greater reduction in headache attack pain intensity in the MBCT-M group vs. WL/TAU.|||0.16|-0.14|.888
72384313|NCT02443519|144276322|SUPERIORITY||Slope|7.45||||0.035|TWO_SIDED|95.0|2.48|12.42|||Mixed Models Analysis|The key test was the Treatment (MBCT-M vs. WL.TAU) X Time (Month 1 vs 4) interaction with both Treatment and Time in the model.|A positive slope indicates a greater reduction in Pain Catastrophizing Scale in the MBCT-M group vs. WL/TAU.|||12.42|2.48|.035
72384314|NCT02443519|144276323|SUPERIORITY||Slope|-3.05||||0.572|TWO_SIDED|95.0|-10.83|4.74|||Mixed Models Analysis|The key test was the Treatment (MBCT-M vs. WL.TAU) X Time (Month 1 vs 4) interaction with both Treatment and Time in the model.|A negative slope indicates a greater improvement in Chronic Pain Acceptance in the MBCT-M group vs. WL/TAU.|||4.74|-10.83|.572
72494596|NCT00662792|144518627|SUPERIORITY||Difference of adjusted means|17.4|STANDARD_ERROR_OF_MEAN|2.3|<|0.0001|TWO_SIDED|95.0|12.9|21.9|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (Salm50DPI)|||21.9|12.9|<.0001
72494597|NCT00662792|144518627|SUPERIORITY||Difference of adjusted means|-8.2|STANDARD_ERROR_OF_MEAN|2.3||0.0004|TWO_SIDED|95.0|-12.7|-3.7|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (T18GEL+S\_DPI)|||-3.7|-12.7|0.0004
72558307|NCT04547192|144645951|SUPERIORITY|Power calculation - Expected enrollment: 25 patients/hospital/month, giving a total of 3,500 patients across all hospitals over 17.5 months. With an alpha of 0.05 and baseline TIF adherence rate of 50%, there was 80% power to detect 8.1-8.6% difference in KPI performance with 0.15-0.40 range in COV.|Odds Ratio (OR)|5.18||||0.006|TWO_SIDED||||||generalized linear mixed regression|||Tetanus Considered for bites, burns, lacerations, and abrasions||||0.006
72558308|NCT04547192|144645951|SUPERIORITY|Power calculation - Expected enrollment: 25 patients/hospital/month, giving a total of 3,500 patients across all hospitals over 17.5 months. With an alpha of 0.05 and baseline TIF adherence rate of 50%, there was 80% power to detect 8.1-8.6% difference in KPI performance with 0.15-0.40 range in COV.|Odds Ratio (OR)|0.03||||0.047|TWO_SIDED||||||generalized linear mixed regression|||Date of Injury Recorded||||0.047
72558309|NCT04547192|144645951|SUPERIORITY|Power calculation - Expected enrollment: 25 patients/hospital/month, giving a total of 3,500 patients across all hospitals over 17.5 months. With an alpha of 0.05 and baseline TIF adherence rate of 50%, there was 80% power to detect 8.1-8.6% difference in KPI performance with 0.15-0.40 range in COV.|Odds Ratio (OR)|0.42||||0.166|TWO_SIDED||||||generalized linear mixed regression|||Death||||0.166
72558310|NCT04547192|144645951|SUPERIORITY|Power calculation - Expected enrollment: 25 patients/hospital/month, giving a total of 3,500 patients across all hospitals over 17.5 months. With an alpha of 0.05 and baseline TIF adherence rate of 50%, there was 80% power to detect 8.1-8.6% difference in KPI performance with 0.15-0.40 range in COV.|Odds Ratio (OR)|2.14||||0.013|TWO_SIDED||||||generalized linear mixed regression|||Important Clinical Data Document||||0.013
72436321|NCT01157182|144385801|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|96.01|||||TWO_SIDED|90.0|92.14|100.04|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||100.04|92.14|
72436322|NCT01157182|144385802|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|96.75|||||TWO_SIDED|90.0|92.75|100.93|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||100.93|92.75|
72436323|NCT00716144|144385912|SUPERIORITY_OR_OTHER|||||||0.884|||||||Cochran-Armitage Trend Test|||||||0.884
72436324|NCT00716144|144385913|SUPERIORITY_OR_OTHER|||||||1|||||||Cochran-Armitage Trend Test|||At Visit 3||||1.000
72436325|NCT00716144|144385913|SUPERIORITY_OR_OTHER|||||||0.604|||||||Cochran-Armitage Trend Test|||At Visit 4||||0.604
72436326|NCT00716144|144385913|SUPERIORITY_OR_OTHER|||||||0.463|||||||Cochran-Armitage Trend Test|||At Visit 5||||0.463
72436327|NCT00716144|144385913|SUPERIORITY_OR_OTHER|||||||0.042|||||||Cochran-Armitage Trend Test|||At Visit 6||||0.042
72558311|NCT04547192|144645952|SUPERIORITY||Odds Ratio (OR)|0.42||||0.166|TWO_SIDED||||||generalized linear mixed regression|||||||0.166
72436328|NCT00716144|144385913|SUPERIORITY_OR_OTHER|||||||0.034|||||||Cochran-Armitage Trend Test|||At Visit 7||||0.034
72436329|NCT00716144|144385913|SUPERIORITY_OR_OTHER|||||||0.019|||||||Cochran-Armitage Trend Test|||At Visit 8||||0.019
72436330|NCT00716144|144385915|SUPERIORITY_OR_OTHER|||||||1|||||||Cochran-Armitage Trend Test|||At Visit 3||||1.000
72436331|NCT00716144|144385915|SUPERIORITY_OR_OTHER|||||||0.673|||||||Cochran-Armitage Trend Test|||At Visit 4||||0.673
72436332|NCT00716144|144385915|SUPERIORITY_OR_OTHER|||||||0.55|||||||Cochran-Armitage Trend Test|||At Visit 5||||0.550
72436333|NCT00716144|144385915|SUPERIORITY_OR_OTHER|||||||0.721|||||||Cochran-Armitage Trend Test|||At Visit 7||||0.721
72436334|NCT00716144|144385915|SUPERIORITY_OR_OTHER|||||||0.03|||||||Cochran-Armitage Trend Test|||At Visit 8||||0.030
72436335|NCT02950558|144385926|OTHER|||||||0.1269|||||||Wilcoxon (Mann-Whitney)|||||||0.1269
72436336|NCT02950558|144385927|OTHER|||||||0.8808|||||||Wilcoxon (Mann-Whitney)|||||||0.8808
72436337|NCT02950558|144385928|OTHER|||||||0.0382|||||||Wilcoxon (Mann-Whitney)|||||||0.0382
72436338|NCT02950558|144385929|OTHER|||||||0.4696|||||||Wilcoxon (Mann-Whitney)|||||||0.4696
72436339|NCT02950558|144385930|OTHER|||||||0.1818|||||||Fisher Exact|||||||0.1818
72436340|NCT02914522|144385945|SUPERIORITY||Difference in Percentages|10.8||||0.0157|TWO_SIDED|95.0|2.1|19.5|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel(CMH) test was stratified by concomitant use of oral, systemic corticosteroids (Yes/No) and immunomodulators (Yes/No) at Day 1.||||19.5|2.1|0.0157
72436341|NCT02914522|144385945|SUPERIORITY||Difference in Percentages|3.8||||0.3379|TWO_SIDED|95.0|-4.3|12.0|||Cochran-Mantel-Haenszel|CMH test was stratified by concomitant use of oral, systemic corticosteroids (Yes or No) and of immunomodulators (Yes or No) at Day 1.||||12.0|-4.3|0.3379
72436342|NCT02914522|144385945|SUPERIORITY||Difference in Percentages|7.2||||0.0103|TWO_SIDED|95.0|1.6|12.8|||Cochran-Mantel-Haenszel|CMH was stratified by concomitant use of corticosteroids and of immunomodulators at Day 1, and number of prior exposure to biologic agent (≤1,\>1).||||12.8|1.6|0.0103
72436343|NCT02914522|144385945|SUPERIORITY||Difference in Percentages|5.2||||0.0645|TWO_SIDED|95.0|0.0|10.5|||Cochran-Mantel-Haenszel|CMH was stratified by concomitant use of corticosteroids and of immunomodulators at Day 1, and number of prior exposure to biologic agent (≤1,\>1).||||10.5|-0.0|0.0645
72436344|NCT02914522|144385946|SUPERIORITY||Difference in Percentages|26.0|||<|0.0001|TWO_SIDED|95.0|16.0|35.9|||Cochran-Mantel-Haenszel|CMH test was stratified by concomitant use of corticosteroids and of immunomodulators at maintenance baseline; participation in Induction (A or B).||||35.9|16.0|< 0.0001
72558312|NCT04723693|144646107|OTHER||||||||||||||||||This is a qualitative interview study and as such no statistical analysis was carried out.|||
72384315|NCT02443519|144276324|SUPERIORITY||Slope|-2.65||||0.609|TWO_SIDED|95.0|-11.76|6.46||Threshold for significance set a priori at .05.|Mixed Models Analysis|The key test was the Treatment (MBCT-M vs. WL.TAU) X Time (Month 1 vs 4) interaction with both Treatment and Time in the model.|A negative slope indicates a smaller decrease in the Five Factor Mindfulness Questionnaire in the MBCT-M group vs. WL/TAU.|||6.46|-11.76|.609
72384316|NCT02443519|144276325|SUPERIORITY||Slope|8.45||||0.022|TWO_SIDED|95.0|2.99|13.91||Threshold for significance set a priori at .05.|Mixed Models Analysis|The key test was the Treatment (MBCT-M vs. WL.TAU) X Time (Month 1 vs 4) interaction with both Treatment and Time in the model.|A positive slope indicates a greater reduction in Headache Specific Locus of Control Scale score in the MBCT-M group vs. WL/TAU.|||13.91|2.99|.022
72384317|NCT02443519|144276326|SUPERIORITY||Slope|-2.01||||0.124|TWO_SIDED|95.0|-7.56|3.53||Threshold for significance set a priori at .05.|Mixed Models Analysis|The key test was the Treatment (MBCT-M vs. WL.TAU) X Time (Month 1 vs 4) interaction with both Treatment and Time in the model.|A negative slope indicates a greater improvement in Headache Management Self-Efficacy Scale score in the MBCT-M group vs. WL/TAU.|||3.53|-7.56|.124
72558313|NCT04723693|144646108|OTHER||||||||||||||||||This is a qualitative interview study and as such no statistical analysis was carried out.|||
72436345|NCT02914522|144385946|SUPERIORITY||Difference in Percentages|10.4||||0.042|TWO_SIDED|95.0|0.0|20.7|||Cochran-Mantel-Haenszel|CMH test was stratified by concomitant use of corticosteroids and of immunomodulators at maintenance baseline; participation in Induction (A or B).||||20.7|-0.0|0.0420
72436346|NCT02914522|144385947|SUPERIORITY||Difference in Percentages|12.1||||0.0053|TWO_SIDED|95.0|3.8|20.4|||Cochran-Mantel-Haenszel|CMH test is stratified by concomitant use of oral, systemic corticosteroids (Yes or No) and of immunomodulators (Yes or No) at Day 1.||||20.4|3.8|0.0053
72436347|NCT02914522|144385947|SUPERIORITY||Difference in Percentages|4.6||||0.2295|TWO_SIDED|95.0|-3.1|12.2|||Cochran-Mantel-Haenszel|CMH test is stratified by concomitant use of oral, systemic corticosteroids (Yes or No) and of immunomodulators (Yes or No) at Day 1.||||12.2|-3.1|0.2295
72436348|NCT02914522|144385947|SUPERIORITY||Difference in Percentages|5.3||||0.0393|TWO_SIDED|95.0|-0.1|10.7|||Cochran-Mantel-Haenszel|CMH was stratified by concomitant use of corticosteroids and of immunomodulators at Day 1, and number of prior exposure to biologic agent (≤1,\>1).||||10.7|-0.1|0.0393
72436349|NCT02914522|144385947|SUPERIORITY||Difference in Percentages|1.7||||0.5308|TWO_SIDED|95.0|-3.1|6.6|||Cochran-Mantel-Haenszel|CMH was stratified by concomitant use of corticosteroids and of immunomodulators at Day 1, and number of prior exposure to biologic agent (≤1,\>1).||||6.6|-3.1|0.5308
72436350|NCT02914522|144385948|SUPERIORITY||Difference in Percentages|8.6||||0.0047|TWO_SIDED|95.0|2.9|14.3|||Cochran-Mantel-Haenszel|CMH test is stratified by concomitant use of oral, systemic corticosteroids (Yes or No) and of immunomodulators (Yes or No) at Day 1.||||14.3|2.9|0.0047
72436351|NCT02914522|144385948|SUPERIORITY||Difference in Percentages|2.1||||0.3495|TWO_SIDED|95.0|-2.6|6.8|||Cochran-Mantel-Haenszel|CMH test is stratified by concomitant use of oral, systemic corticosteroids (Yes or No) and of immunomodulators (Yes or No) at Day 1.||||6.8|-2.6|0.3495
72436352|NCT02914522|144385948|SUPERIORITY||Difference in Percentages|1.3||||0.4269|TWO_SIDED|95.0|-2.5|5.1|||Cochran-Mantel-Haenszel|CMH was stratified by concomitant use of corticosteroids and of immunomodulators at Day 1, and number of prior exposure to biologic agent (≤1,\>1).||||5.1|-2.5|0.4269
72436353|NCT02914522|144385948|SUPERIORITY||Difference in Percentages|0.0||||0.9987|TWO_SIDED|95.0|-3.4|3.4|||Cochran-Mantel-Haenszel|CMH was stratified by concomitant use of corticosteroids and of immunomodulators at Day 1, and number of prior exposure to biologic agent (≤1,\>1).||||3.4|-3.4|0.9987
72436354|NCT02914522|144385949|SUPERIORITY||Difference in Percentages|19.0|||<|0.0001|TWO_SIDED|95.0|9.9|28.2|||Cochran-Mantel-Haenszel|CMH test is stratified by concomitant use of oral, systemic corticosteroids (Yes or No) and of immunomodulators (Yes or No) at Day 1.||||28.2|9.9|<0.0001
72436355|NCT02914522|144385949|SUPERIORITY||Difference in Percentages|7.8||||0.0672|TWO_SIDED|95.0|-0.7|16.2|||Cochran-Mantel-Haenszel|CMH test is stratified by concomitant use of oral, systemic corticosteroids (Yes or No) and of immunomodulators (Yes or No) at Day 1.||||16.2|-0.7|0.0672
72436356|NCT02914522|144385949|SUPERIORITY||Difference in Percentages|11.4||||0.0019|TWO_SIDED|95.0|4.2|18.6|||Cochran-Mantel-Haenszel|CMH was stratified by concomitant use of corticosteroids and of immunomodulators at Day 1, and number of prior exposure to biologic agent (≤1,\>1).||||18.6|4.2|0.0019
72436357|NCT02914522|144385949|SUPERIORITY||Difference in Percentages|5.2||||0.1286|TWO_SIDED|95.0|-1.4|11.8|||Cochran-Mantel-Haenszel|CMH was stratified by concomitant use of corticosteroids and of immunomodulators at Day 1, and number of prior exposure to biologic agent (≤1,\>1).||||11.8|-1.4|0.1286
72436358|NCT02914522|144385950|SUPERIORITY||Difference in Percentages|7.9||||0.0105|TWO_SIDED|95.0|1.9|13.8|||Cochran-Mantel-Haenszel|CMH test is stratified by concomitant use of oral, systemic corticosteroids (Yes or No) and of immunomodulators (Yes or No) at Day 1||||13.8|1.9|0.0105
72436359|NCT02914522|144385950|SUPERIORITY||Difference in Percentages|4.3||||0.1062|TWO_SIDED|95.0|-1.0|9.6|||Cochran-Mantel-Haenszel|CMH test is stratified by concomitant use of oral, systemic corticosteroids (Yes or No) and of immunomodulators (Yes or No) at Day 1||||9.6|-1.0|0.1062
72436360|NCT02914522|144385950|SUPERIORITY||Difference in Percentages|1.7||||0.3084|TWO_SIDED|95.0|-2.2|5.6|||Cochran-Mantel-Haenszel|CMH was stratified by concomitant use of corticosteroids and of immunomodulators at Day 1, and number of prior exposure to biologic agent (≤1,\>1).||||5.6|-2.2|0.3084
72436361|NCT02914522|144385950|SUPERIORITY||Difference in Percentages|0.0||||0.9109|TWO_SIDED|95.0|-3.4|3.4|||Cochran-Mantel-Haenszel|CMH was stratified by concomitant use of corticosteroids and of immunomodulators at Day 1, and number of prior exposure to biologic agent (≤1,\>1).||||3.4|-3.4|0.9109
72436362|NCT02914522|144385956|SUPERIORITY||Difference in Percentages|25.5|||<|0.0001|TWO_SIDED|95.0|16.0|35.0|||Cochran-Mantel-Haenszel|CMH test was stratified by concomitant use of corticosteroids and of immunomodulators at maintenance baseline; participation in Induction (A or B).||||35.0|16.0|<0.0001
72558314|NCT01410227|144646109|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The null hypothesis of the rate of subjects with a treatment success of \<= 0.65 (H0: p \<= 0.65) versus an alternative hypothesis of \> 0.65 (HA: p \> 0.65) was tested at the 5% one-sided level of significance. The proportion of subjects with treatment success under the alternative hypothesis was expected to be approximately 0.90. If 20 subjects were treated, the study provided 86% power to reject the null hypothesis.|Clopper-Pearson|100.0|||||TWO_SIDED|90.0|84.7|100.0|||Clopper-Pearson|||||100|84.7|
72384318|NCT02443519|144276327|SUPERIORITY||Slope|3.48||||0.017|TWO_SIDED|95.0|0.63|6.33||Threshold for significance set a priori at .05.|Mixed Models Analysis|The key test was the Treatment (MBCT-M vs. WL.TAU) X Time (Month 1 vs 4) interaction with both Treatment and Time in the model.|A positive slope indicates a greater reduction in PROMIS-Depression score in the MBCT-M group vs. WL/TAU.|||6.33|0.63|.017
72384319|NCT02443519|144276328|SUPERIORITY||Slope|2.82||||0.259|TWO_SIDED|95.0|-0.03|5.68||Threshold for significance set a priori at .05.|Mixed Models Analysis|The key test was the Treatment (MBCT-M vs. WL.TAU) X Time (Month 1 vs 4) interaction with both Treatment and Time in the model.|A positive slope indicates a greater reduction in PROMIS-Anxiety score in the MBCT-M group vs. WL/TAU.|||5.68|-0.03|.259
72384320|NCT02443519|144276329|SUPERIORITY||Slope|-1.0||||0.007|TWO_SIDED|95.0|-1.6|-0.3|||Mixed Models Analysis|The key test was the Treatment (MBCT-M vs. WL/TAU) X Time (Month 1 vs. 4) interaction with both Treatment and Time in the model.|A negative slope indicated a larger decrease in MIDI scores in the MBCT-M group vs. WL/TAU|||-0.3|-1.6|.007
72384321|NCT00932737|144276330|OTHER||Adjusted mean difference|-0.7|STANDARD_ERROR_OF_MEAN|0.29||0.0156|TWO_SIDED|95.0|-1.3|-0.1|||Mixed effect model||The adjusted mean difference between Hyoscine butylbromide minus Placebo was calculated.|A model included fixed, categorical effects of treatment group, episode, interval and center, as well as the treatment-by-episode interaction, with the covariate of baseline intensity of Abdominal pain associated with cramping . An unstructured covariance structure was used to model the within-patient errors.||-0.1|-1.3|0.0156
72384322|NCT00932737|144276331|OTHER||Adjusted mean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.3||0.0512|TWO_SIDED|95.0|-1.2|0.0|||Mixed effect model||The adjusted mean difference between Hyoscine butylbromide minus Placebo was calculated.|A model included fixed, categorical effects of treatment group, episode, interval and center, as well as the treatment-by-episode interaction, with the covariate of baseline intensity of Abdominal pain associated with cramping . An unstructured covariance structure was used to model the within-patient errors.||0.0|-1.2|0.0512
72384323|NCT00932737|144276332|OTHER||Adjusted mean difference|-0.7|STANDARD_ERROR_OF_MEAN|0.32||0.0351|TWO_SIDED|95.0|-1.3|0.0|||ANCOVA||The adjusted mean difference between Hyoscine butylbromide minus Placebo was calculated.|The analysis of covariance (ANCOVA) was performed on the change from baseline to the last recorded rating of intensity for each treated episode of Abdominal pain associated with cramping (APC). The statistical model included the main effects of treatment, episode, and center as well as terms for the treatment-by-episode interaction, with baseline intensity of APC for the respective episode as a covariate.||0.0|-1.3|0.0351
72384324|NCT00932737|144276333|OTHER||Adjusted mean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.35||0.3557|TWO_SIDED|95.0|-1.0|0.4|||ANCOVA||The adjusted mean difference between Hyoscine butylbromide and Placebo was calculated.|The analysis of covariance (ANCOVA) was performed on the change from baseline to the last recorded rating of intensity for each treated episode of Abdominal pain associated with cramping (APC). The statistical model included the main effects of treatment, episode, and center as well as terms for the treatment-by-episode interaction, with baseline intensity of APC for the respective episode as a covariate.||0.4|-1.0|0.3557
72384325|NCT00932737|144276334|OTHER||Odds Ratio (OR)|1.071||||0.831|TWO_SIDED|95.0|0.572|2.004|||Regression, Logistic|Logistic regression included the main effects of treatment group, episode, and center.||||2.004|0.572|0.831
72384326|NCT00932737|144276335|OTHER||Odds Ratio (OR)|1.222||||0.557|TWO_SIDED|95.0|0.626|2.387|||Regression, Logistic|Logistic regression included the main effects of treatment group, episode, and center.||||2.387|0.626|0.557
72384327|NCT00932737|144276336|OTHER||Odds Ratio (OR)|0.737||||0.396|TWO_SIDED|95.0|0.365|1.49|||Regression, Logistic|Logistic regression included the main effects of treatment group, episode, and center.||||1.490|0.365|0.396
72384328|NCT00932737|144276337|OTHER||Odds Ratio (OR)|1.336||||0.448|TWO_SIDED|95.0|0.632|2.827|||Regression, Logistic|Logistic regression included the main effects of treatment group, episode, and center.||||2.827|0.632|0.448
72384329|NCT00932737|144276338|OTHER||Odds Ratio (OR)|2.474||||0.03|TWO_SIDED|95.0|1.093|5.604|||Regression, Logistic|Logistic regression included the main effects of treatment group, episode, and center.||||5.604|1.093|0.030
72384330|NCT00932737|144276339|OTHER||Odds Ratio (OR)|1.654||||0.167|TWO_SIDED|95.0|0.81|3.378|||Regression, Logistic|Logistic regression included the main effects of treatment group, episode, and center.||||3.378|0.810|0.167
72384331|NCT00932737|144276340|OTHER|||||||0.256|||||||Log Rank|Log rank test was used for comparison of Hyoscine butylbromide (Buscopan®) 20 mg group versus Placebo group.||||||0.2560
72384332|NCT00932737|144276341|OTHER|||||||0.5179|||||||Log Rank|Log rank test was used for comparison of Hyoscine butylbromide (Buscopan®) 20 mg group versus Placebo group.||||||0.5179
72436363|NCT02914522|144385956|SUPERIORITY||Difference in Percentages|9.2||||0.0658|TWO_SIDED|95.0|-1.1|19.5|||Cochran-Mantel-Haenszel|CMH test was stratified by concomitant use of corticosteroids and of immunomodulators at maintenance baseline; participation in Induction (A or B).||||19.5|-1.1|0.0658
72436364|NCT02914522|144385957|SUPERIORITY||Difference in Percentages|13.0||||0.0024|TWO_SIDED|95.0|5.3|20.6|||Cochran-Mantel-Haenszel|CMH test was stratified by concomitant use of corticosteroids and of immunomodulators at maintenance baseline; participation in Induction (A or B).||||20.6|5.3|0.0024
72436365|NCT02914522|144385957|SUPERIORITY||Difference in Percentages|0.9||||0.7951|TWO_SIDED|95.0|-7.0|8.7|||Cochran-Mantel-Haenszel|CMH test was stratified by concomitant use of corticosteroids and of immunomodulators at maintenance baseline; participation in Induction (A or B).||||8.7|-7.0|0.7951
72436366|NCT02914522|144385958|SUPERIORITY||Difference in Percentages|20.8||||0.0055|TWO_SIDED|95.0|7.7|33.9|||Cochran-Mantel-Haenszel|CMH test was stratified by concomitant use of corticosteroids and of immunomodulators at maintenance baseline; participation in Induction (A or B).||||33.9|7.7|0.0055
72436367|NCT02914522|144385958|SUPERIORITY||Difference in Percentages|8.2||||0.1265|TWO_SIDED|95.0|-4.2|20.6|||Cochran-Mantel-Haenszel|CMH test was stratified by concomitant use of corticosteroids and of immunomodulators at maintenance baseline; participation in Induction (A or B).||||20.6|-4.2|0.1265
72494598|NCT00662792|144518628|SUPERIORITY||Difference of adjusted means|13.1|STANDARD_ERROR_OF_MEAN|3.0|<|0.0001|TWO_SIDED|95.0|7.2|18.9|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (Tio18GEL)|||18.9|7.2|<.0001
72558315|NCT00911274|144646198|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Geometric Test/Ref Ratio x 100|92.41||||||90.0|82.77|103.18|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||103.18|82.77|
72558316|NCT00911274|144646199|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Geometric Test/Ref Ratio x 100|101.3||||||90.0|97.84|104.88|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||104.88|97.84|
72558317|NCT00911274|144646200|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Geometric Test/Ref Ratio x 100|101.0||||||90.0|97.77|104.34|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||104.34|97.77|
72558318|NCT02412852|144646209|OTHER||||||||||||||||||\]The pharmacokinetics data are particularly sparse, and therefore substantial interpolations and imputations were required to produce an analyzable data set. Consequently, while not ideal, the Last Observation Carried Forward method was used for these data. There was a large amount of missing data which required imputation to determine results. The large amount of interpolations and imputations required for the pharmacokinetic analysis means that the pharmacokinetic results will need to be interpreted with caution. 3 X 3 Analysis of Variance used to compare Placebo to the two active groups. Missing data required imputation of available data.|||
72558319|NCT02412852|144646211|OTHER|ANOVA on only those subjects who completed testing.||||||0.05||||||The results were analyzed using an ANOVA with one between-subjects factor (Group: both placebo groups combined, 40 mg TV1001sr, and 80 mg TV1001sr); and one within-subjects factor (Visit: Visit 1, Visit 2, and Visit 3).|ANOVA|The means of the three groups were further analyzed using a post hoc comparison procedure (the Scheffé test).||||||0.05
72384333|NCT04399837|144276351|OTHER|The generalized MCP-Mod procedure for time to event endpoints is based on the log hazard ratio of the active doses vs. placebo obtained via a Cox regression model on the time to first GPP flare.|Multiple contrast test|3.041||||0.002|||||||MCP-Mod linear model fit|Model assumption: Dose effect is linear with the increase of dose.||A flat vs. non-flat dose-response relationship across the 3 doses of spesolimab and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 4 different plausible dose-response patterns (linear, Emax 1, Emax 2 and exponential) while protecting the overall probability of type I error (one-sided alpha of 0.05).||||0.002
72494599|NCT00662792|144518628|SUPERIORITY||Difference of adjusted means|23.1|STANDARD_ERROR_OF_MEAN|3.0|<|0.0001|TWO_SIDED|95.0|17.2|28.9|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (Salm50DPI)|||28.9|17.2|<.0001
72558320|NCT02412852|144646212|OTHER|The composite conduction measure and the composite velocity measure were analyzed using an Analysis of Variance with one between-subjects factor (Group: combined placebo, 40 mg TV1001, and 80 mg TV1001); and one within-subjects factor (Visit: Visit 1, Visit 2, and Visit 3).||||||0.15|||||||ANOVA|||||||.15
72558321|NCT02412852|144646213|OTHER|A 3 by 3 Analysis of Variance with one between-subjects factor (Combined placebo, 40 mg TV1001, or 80 mg TV1001) and one within-subjects factor (Visit 1, Visit 2, or Visit 3) was performed for HbA1c values.||||||0.36|||||||ANOVA|||||||.36
72384334|NCT04399837|144276351|OTHER|The generalized MCP-Mod procedure for time to event endpoints is based on the log hazard ratio of the active doses vs. placebo obtained via a Cox regression model on the time to first GPP flare.|Multiple contrast test|3.033||||0.002|||||||MCP-Mod Emax2 model fit|Model assumption: 95% of the maximum effect is achieved at low dose.||A flat vs. non-flat dose-response relationship across the 3 doses of spesolimab and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 4 different plausible dose-response patterns (linear, Emax 1, Emax 2 and exponential) while protecting the overall probability of type I error (one-sided alpha of 0.05).||||0.002
72384335|NCT04399837|144276351|OTHER|The generalized MCP-Mod procedure for time to event endpoints is based on the log hazard ratio of the active doses vs. placebo obtained via a Cox regression model on the time to first GPP flare.|Multiple contrast test|3.088||||0.002|||||||MCP-Mod Emax1 model fit|Model assumption: 70% of the maximum effect is achieved at low dose.||A flat vs. non-flat dose-response relationship across the 3 doses of spesolimab and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 4 different plausible dose-response patterns (linear, Emax 1, Emax 2 and exponential) while protecting the overall probability of type I error (one-sided alpha of 0.05).||||0.002
72384336|NCT04399837|144276351|OTHER|The generalized MCP-Mod procedure for time to event endpoints is based on the log hazard ratio of the active doses vs. placebo obtained via a Cox regression model on the time to first GPP flare.|Multiple contrast test|2.977||||0.003|||||||MCP-Mod exponential model fit|Model assumption: 35% of the maximum effect is achieved at medium dose.||A flat vs. non-flat dose-response relationship across the 3 doses of spesolimab and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 4 different plausible dose-response patterns (linear, Emax 1, Emax 2 and exponential) while protecting the overall probability of type I error (one-sided alpha of 0.05).||||0.003
72494600|NCT00662792|144518628|SUPERIORITY||Difference in adjusted means|-5.3|STANDARD_ERROR_OF_MEAN|3.0||0.0769|TWO_SIDED|95.0|-11.2|0.6|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (T18GEL+S-DPI)|||0.6|-11.2|0.0769
72494601|NCT00662792|144518629|SUPERIORITY||Difference of adjusted means|2.8|STANDARD_ERROR_OF_MEAN|3.2||0.3775|TWO_SIDED|95.0|-3.5|9.1|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (Tio18GEL)|||9.1|-3.5|0.3775
72558322|NCT02412852|144646214|OTHER|ANOVA to compare differences from baseline to completion of testing.||||||0.93|||||||ANOVA|||||||.93
72494602|NCT00662792|144518629|SUPERIORITY||Difference of adjusted means|7.1|STANDARD_ERROR_OF_MEAN|3.2||0.0285|TWO_SIDED|95.0|0.7|13.4|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (Salm50DPI)|||13.4|0.7|0.0285
72436368|NCT02914522|144385959|SUPERIORITY||Difference in Percentages|9.5||||0.0157|TWO_SIDED|95.0|1.8|17.1|||Cochran-Mantel-Haenszel|CMH test was stratified by concomitant use of corticosteroids and of immunomodulators at maintenance baseline; participation in Induction (A or B).||||17.1|1.8|0.0157
72436369|NCT02914522|144385959|SUPERIORITY||Difference in Percentages|5.5||||0.1808|TWO_SIDED|95.0|-2.9|13.9|||Cochran-Mantel-Haenszel|CMH test was stratified by concomitant use of corticosteroids and of immunomodulators at maintenance baseline; participation in Induction (A or B).||||13.9|-2.9|0.1808
72494603|NCT00662792|144518629|SUPERIORITY||Difference of adjusted means|-8.9|STANDARD_ERROR_OF_MEAN|3.2||0.0065|TWO_SIDED|95.0|-15.2|-2.5|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (T18GEL+S-DPI)|||-2.5|-15.2|0.0065
72494604|NCT00662792|144518633|SUPERIORITY||Difference of adjusted means|5.7|STANDARD_ERROR_OF_MEAN|2.4||0.0182|TWO_SIDED|95.0|1.0|10.4|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (Tio18GEL)|Morning PEF||10.4|1.0|0.0182
72494605|NCT00662792|144518633|SUPERIORITY||Difference of adjusted means|6.3|STANDARD_ERROR_OF_MEAN|2.4||0.0091|TWO_SIDED|95.0|1.6|11.1|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (Salm50DPI)|Morning PEF||11.1|1.6|0.0091
72494606|NCT00662792|144518633|SUPERIORITY||Difference of adjusted means|-8.0|STANDARD_ERROR_OF_MEAN|2.4||0.001|TWO_SIDED|95.0|-12.8|-3.3|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (T18GEL+S-DPI)|Morning PEF||-3.3|-12.8|0.0010
72494607|NCT00662792|144518633|SUPERIORITY||Difference of adjusted means|11.0|STANDARD_ERROR_OF_MEAN|2.6|<|0.0001|TWO_SIDED|95.0|5.8|16.2|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (Tio18GEL)|Evening PEF||16.2|5.8|<.0001
72494608|NCT00662792|144518633|SUPERIORITY||Difference of adjusted means|23.3|STANDARD_ERROR_OF_MEAN|2.7|<|0.0001|TWO_SIDED|95.0|18.1|28.6|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (Salm50DPI)|Evening PEF||28.6|18.1|<.0001
72494609|NCT00662792|144518633|SUPERIORITY||Difference of adjusted means|1.5|STANDARD_ERROR_OF_MEAN|2.7||0.5766|TWO_SIDED|95.0|-3.8|6.8|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (T18GEL+S-DPI)|Evening PEF||6.8|-3.8|0.5766
72494610|NCT00662792|144518634|SUPERIORITY||Difference of adjusted means|0.04|STANDARD_ERROR_OF_MEAN|0.016||0.0137|TWO_SIDED|95.0|0.008|0.071|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (Tio18GEL)|Morning FEV1||0.071|0.008|0.0137
72494611|NCT00662792|144518634|SUPERIORITY||Difference of adjusted means|0.027|STANDARD_ERROR_OF_MEAN|0.016||0.0981|TWO_SIDED|95.0|-0.005|0.059|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (Salm50DPI)|Morning FEV1||0.059|-0.005|0.0981
72436370|NCT02914522|144385960|SUPERIORITY||Difference in Percentages|24.9|||<|0.0001|TWO_SIDED|95.0|14.6|35.2|||Cochran-Mantel-Haenszel|CMH test was stratified by concomitant use of corticosteroids and of immunomodulators at maintenance baseline; participation in Induction (A or B).||||35.2|14.6|<0.0001
72436371|NCT02914522|144385960|SUPERIORITY||Difference in Percentages|9.9||||0.0521|TWO_SIDED|95.0|-1.3|21.2|||Cochran-Mantel-Haenszel|CMH test was stratified by concomitant use of corticosteroids and of immunomodulators at maintenance baseline; participation in Induction (A or B).||||21.2|-1.3|0.0521
72494612|NCT00662792|144518634|SUPERIORITY||Difference of adjusted means|-0.022|STANDARD_ERROR_OF_MEAN|0.016||0.1827|TWO_SIDED|95.0|-0.054|0.01|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (T18GEL+S-DPI)|Morning FEV1||0.010|-0.054|0.1827
72494613|NCT00662792|144518634|SUPERIORITY||Difference of adjusted means|0.057|STANDARD_ERROR_OF_MEAN|0.018||0.0014|TWO_SIDED|95.0|0.022|0.092|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (Tio18GEL)|Evening FEV1||0.092|0.022|0.0014
72494614|NCT00662792|144518634|SUPERIORITY||Difference of adjusted means|0.105|STANDARD_ERROR_OF_MEAN|0.018|<|0.0001|TWO_SIDED|95.0|0.07|0.14|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (Salm50DPI)|Evening FEV1||0.140|0.070|<.0001
72494615|NCT00662792|144518634|SUPERIORITY||Difference of adjusted means|0.02|STANDARD_ERROR_OF_MEAN|0.018||0.2584|TWO_SIDED|95.0|-0.015|0.056|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (T18GEL+S-DPI)|Evening FEV1||0.056|-0.015|0.2584
72494616|NCT00662792|144518635|SUPERIORITY||Difference of adjusted means|-0.07|STANDARD_ERROR_OF_MEAN|0.02||0.0027|TWO_SIDED|95.0|-0.11|-0.02|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (Tio18GEL)|Daytime||-0.02|-0.11|0.0027
72494617|NCT00662792|144518635|SUPERIORITY||Difference of adjusted means|-0.02|STANDARD_ERROR_OF_MEAN|0.02||0.4587|TWO_SIDED|95.0|-0.06|0.03|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (Salm50DPI)|Daytime||0.03|-0.06|0.4587
72494618|NCT00662792|144518635|SUPERIORITY||Difference of adjusted means|0.03|STANDARD_ERROR_OF_MEAN|0.02||0.1535|TWO_SIDED|95.0|-0.01|0.08|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (T18GEL+S-DPI)|Daytime||0.08|-0.01|0.1535
72494619|NCT00662792|144518635|SUPERIORITY||Difference of adjusted means|-0.09|STANDARD_ERROR_OF_MEAN|0.02||0.0002|TWO_SIDED|95.0|-0.14|-0.05|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (Tio18GEL)|Night-time||-0.05|-0.14|0.0002
72494620|NCT00662792|144518635|SUPERIORITY||Difference of adjusted means|-0.09|STANDARD_ERROR_OF_MEAN|0.03||0.0006|TWO_SIDED|95.0|-0.14|-0.04|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (Salm50DPI)|Night-time||-0.04|-0.14|0.0006
72494621|NCT00662792|144518635|SUPERIORITY||Difference of adjusted means|-0.01|STANDARD_ERROR_OF_MEAN|0.03||0.5784|TWO_SIDED|95.0|-0.06|0.04|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (T18GEL+S-DPI)|Night-time||0.04|-0.06|0.5784
72494622|NCT00662792|144518635|SUPERIORITY||Difference of adjusted means|-0.09|STANDARD_ERROR_OF_MEAN|0.02||0.0003|TWO_SIDED|95.0|-0.14|-0.04|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (Tio18GEL)|24 hours||-0.04|-0.14|0.0003
72494623|NCT00662792|144518635|SUPERIORITY||Difference of adjusted means|-0.07|STANDARD_ERROR_OF_MEAN|0.02||0.0042|TWO_SIDED|95.0|-0.12|-0.02|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (Salm50DPI)|24 hours||-0.02|-0.12|0.0042
72494624|NCT00662792|144518635|SUPERIORITY||Difference of adjusted means|0.0|STANDARD_ERROR_OF_MEAN|0.03||0.9978|TWO_SIDED|95.0|-0.05|0.05|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (T18GEL+S-DPI)|24 hours||0.05|-0.05|0.9978
72494625|NCT00662792|144518636|SUPERIORITY||Difference of adjusted means|-0.33|STANDARD_ERROR_OF_MEAN|0.11||0.0029|TWO_SIDED|95.0|-0.55|-0.11|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (Tio18GEL)|Daytime||-0.11|-0.55|0.0029
72558323|NCT02960295|144646223|OTHER|There was no comparison group and no test of statistical significance.||||||||||||||||In this interventional study the number of glucose checks per patient per day was calculated as stated above. There was no comparison group and no test of statistical significance.|This is a simple calculation of the mean (sd) of the number of glucose checks per pt per day|||
72558324|NCT02960295|144646224|OTHER|This is an observational study|||||<|0.05|||||||Pearson correlation (r)|||||||<0.05
72558325|NCT02960295|144646224|OTHER|This is an observational study|||||<|0.05|||||||Pearson correlation coefficient (r)|||||||<0.05
72436372|NCT02914522|144385961|SUPERIORITY||Difference in Percentages|16.0||||0.0005|TWO_SIDED|95.0|7.8|24.2|||Cochran-Mantel-Haenszel|CMH test was stratified by concomitant use of corticosteroids and of immunomodulators at maintenance baseline; participation in Induction (A or B).||||24.2|7.8|0.0005
72436373|NCT02914522|144385961|SUPERIORITY||Difference in Percentages|4.3||||0.2946|TWO_SIDED|95.0|-3.9|12.6|||Cochran-Mantel-Haenszel|CMH test was stratified by concomitant use of corticosteroids and of immunomodulators at maintenance baseline; participation in Induction (A or B).||||12.6|-3.9|0.2946
72436374|NCT05382104|144385970|EQUIVALENCE|A linear mixed-effects model was applied to natural log (ln)-transformed Cmax with treatment, period, and sequence as fixed effects, and participant within sequence as a random effect. Point estimates and their associated 90 percent (%) confidence intervals (CIs) was constructed for the differences between Treatment B versus Treatment A. The point estimates and their associated 90% CIs were then back transformed to provide point estimates and 90% CIs for ratios of Treatment B versus Treatment A.|Geometric Mean Ratio (%)|76.62|||||TWO_SIDED|90.0|71.78|81.78|||||Geometric mean ratio (%) was calculated as 100\*(Treatment B / Treatment A).|||81.78|71.78|
72494626|NCT00662792|144518636|SUPERIORITY||Difference of adjusted means|-0.36|STANDARD_ERROR_OF_MEAN|0.11||0.0012|TWO_SIDED|95.0|-0.58|-0.14|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (Salm50DPI)|Daytime||-0.14|-0.58|0.0012
72436375|NCT05382104|144385970|EQUIVALENCE|A linear mixed-effects model was applied to ln-transformed Cmax with treatment, period, and sequence as fixed effects, and participant within sequence as a random effect. Point estimates and their associated 90% CIs was constructed for differences between Treatment C versus Treatment A. The point estimates and their associated 90% CIs were then back transformed to provide point estimates and 90% CIs for ratios of Treatment C versus Treatment A.|Geometric Mean Ratio (%)|71.61|||||TWO_SIDED|90.0|67.14|76.37|||||Geometric mean ratio (%) was calculated as 100\*(Treatment C / Treatment A).|||76.37|67.14|
72558326|NCT02960295|144646224|OTHER||||||<|0.05|||||||Pearson correlation coefficient (r)|||||||<0.05
72558327|NCT01906372|144646230|SUPERIORITY_OR_OTHER||Frequency of achieving primary endpoint|0.7|||||TWO_SIDED|||||Open label single arm pilot trial without control group.||||||||
72558328|NCT01906372|144646231|SUPERIORITY_OR_OTHER||||||<|0.01|||||||t-test, 2 sided|||||||<0.01
72494627|NCT00662792|144518636|SUPERIORITY||Difference of adjusted means|0.12|STANDARD_ERROR_OF_MEAN|0.07||0.0829|TWO_SIDED|95.0|-0.02|0.25|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (T18GEL+S-DPI)|Daytime||0.25|-0.02|0.0829
72494628|NCT00662792|144518636|SUPERIORITY||Difference of adjusted means|-0.17|STANDARD_ERROR_OF_MEAN|0.07||0.0115|TWO_SIDED|95.0|-0.3|-0.04|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (Tio18GEL)|Night-time||-0.04|-0.30|0.0115
72494629|NCT00662792|144518636|SUPERIORITY||Difference of adjusted means|-0.09|STANDARD_ERROR_OF_MEAN|0.07||0.1772|TWO_SIDED|95.0|-0.22|0.04|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (Salm50DPI)|Night-time||0.04|-0.22|0.1772
72494630|NCT00662792|144518636|SUPERIORITY||Difference of adjusted means|0.04|STANDARD_ERROR_OF_MEAN|0.11||0.6895|TWO_SIDED|95.0|-0.18|0.27|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (T18GEL+S-DPI)|Night-time||0.27|-0.18|0.6895
72494631|NCT00662792|144518636|SUPERIORITY||Difference of adjusted means|-0.52|STANDARD_ERROR_OF_MEAN|0.16||0.0013|TWO_SIDED|95.0|-0.84|-0.21|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (Tio18GEL)|Over 24 hours||-0.21|-0.84|0.0013
72494632|NCT00662792|144518636|SUPERIORITY||Difference of adjusted means|-0.47|STANDARD_ERROR_OF_MEAN|0.16||0.004|TWO_SIDED|95.0|-0.78|-0.15|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (Salm50DPI)|Over 24 hours||-0.15|-0.78|0.0040
72494633|NCT00662792|144518636|SUPERIORITY||Difference of adjusted means|0.16|STANDARD_ERROR_OF_MEAN|0.16||0.3287|TWO_SIDED|95.0|-0.16|0.48|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (T18GEL+S-DPI)|Over 24 hours||0.48|-0.16|0.3287
72558329|NCT00841659|144646252|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of LS Means x 100|99.96||||||90.0|||||||Bioequivalence is established when ratio of means falls within 80-125.|||||
72558330|NCT00841659|144646253|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of LS Means x 100|93.58||||||90.0|||||||Bioequivalence is established when ratio of means falls within 80-125.|||||
72436376|NCT05382104|144385971|EQUIVALENCE|A linear mixed-effects model was applied to ln-transformed AUClast with treatment, period, and sequence as fixed effects, and participant within sequence as a random effect. Point estimates and their associated 90% CIs was constructed for the differences between Treatment B versus Treatment A. The point estimates and their associated 90% CIs were then back transformed to provide point estimates and 90% CIs for ratios of Treatment B versus Treatment A.|Geometric Mean Ratio (%)|84.13|||||TWO_SIDED|90.0|80.74|87.66|||||Geometric mean ratio (%) was calculated as 100\*(Treatment B / Treatment A).|||87.66|80.74|
72436377|NCT05382104|144385971|EQUIVALENCE|A linear mixed-effects model was applied to ln-transformed AUClast with treatment, period, and sequence as fixed effects, and participant within sequence as a random effect. Point estimates and their associated 90% CIs was constructed for differences between Treatment C versus Treatment A. The point estimates and their associated 90% CIs were then back transformed to provide point estimates and 90% CIs for ratios of Treatment C versus Treatment A.|Geometric Mean Ratio (%)|87.35|||||TWO_SIDED|90.0|83.87|90.96|||||Geometric mean ratio (%) was calculated as 100\*(Treatment C / Treatment A).|||90.96|83.87|
72436378|NCT05382104|144385972|EQUIVALENCE|A linear mixed-effects model was applied to ln-transformed AUC0-infinity with treatment, period, and sequence as fixed effects, and participant within sequence as a random effect. Point estimates and their associated 90% CIs was constructed for the differences between Treatment B versus Treatment A. The point estimates and their associated 90% CIs were then back transformed to provide point estimates and 90% CIs for ratios of Treatment B versus Treatment A.|Geometric Mean Ratio (%)|84.74|||||TWO_SIDED|90.0|81.28|88.34|||||Geometric mean ratio (%) was calculated as 100\*(Treatment B / Treatment A).|||88.34|81.28|
72436379|NCT05382104|144385972|EQUIVALENCE|A linear mixed-effects model was applied to ln-transformed AUC0-infinity with treatment, period, and sequence as fixed effects, and participant within sequence as a random effect. Point estimates and their associated 90% CIs was constructed for differences between Treatment C versus Treatment A. The point estimates and their associated 90% CIs were then back transformed to provide point estimates and 90% CIs for ratios of Treatment C versus Treatment A.|Geometric Mean Ratio (%)|87.84|||||TWO_SIDED|90.0|84.3|91.53|||||Geometric mean ratio (%) was calculated as 100\*(Treatment C / Treatment A).|||91.53|84.30|
72436380|NCT03506880|144385978|SUPERIORITY||Mean Difference (Final Values)|0.17|||>|0.05|TWO_SIDED||||||Tukey's Post-Hoc||Estimation parameter used to determine significance between mean values in MADD, SG, and AC group.|It was hypothesized that drinking would increase from baseline to 12-month follow-up for those in the AC, but not for those in the SG and MADD conditions.||||>0.05
72436381|NCT03506880|144385979|SUPERIORITY||Mean Difference (Final Values)|0.16|||<|0.01|TWO_SIDED||||||Tukey's Post-Hoc||Estimation parameter used to determine significance between mean values in MADD, SG, and AC group.|It was also hypothesized that teens in the SG and MADD conditions would report significantly more declining rides with impaired drivers than those in the AC group.||||<0.01
72436382|NCT03506880|144385980|SUPERIORITY||Mean Difference (Final Values)|0.06|||>|0.01|TWO_SIDED||||||Tukey's Post-Hoc||Estimation parameter used to determine significance between mean values in MADD, SG, and AC group.|It was hypothesized that participants in the MADD and SG groups would be significantly less willing to ride in a car with an impaired driver than those in the AC group.||||>0.01
72436383|NCT00367055|144385998|SUPERIORITY_OR_OTHER|||||||0.376||95.0||||p value is for Total AUC(0-10 min)|Van Elteren|||||||0.376
72436384|NCT00367055|144385998|SUPERIORITY_OR_OTHER|||||||0.99||95.0||||p value is for Incremental AUC(0-10 min)|Van Elteren|||||||0.990
72436385|NCT03612804|144386008|SUPERIORITY||Odds Ratio (OR)|1.05||||0.83|TWO_SIDED|95.0|0.67|1.64||P-value not adjusted for multiple comparisons. A priori threshold for statistical significance was 0.05.|Regression, Logistic|Logistic regression model with random intercept for provider and main effect term for study site.|Proactive care arm represents numerator of odds ratio, unstructured care arm represents denominator of odds ratio.|||1.64|0.67|0.83
72436386|NCT03105128|144386016|SUPERIORITY||Adjusted Risk Difference|20.7|||<|0.001|TWO_SIDED|95.0|12.4|29.0|||Cochran-Mantel-Haenszel|||||29.0|12.4|<0.001
72436387|NCT03105128|144386016|SUPERIORITY||Adjusted Risk Difference|16.7|||<|0.001|TWO_SIDED|95.0|8.5|24.9|||Cochran-Mantel-Haenszel|||||24.9|8.5|<0.001
72436388|NCT03105128|144386017|SUPERIORITY||Adjusted Risk Difference|28.3|||<|0.001|TWO_SIDED|95.0|21.2|35.4|||Cochran-Mantel-Haenszel|||||35.4|21.2|<0.001
72436389|NCT03105128|144386017|SUPERIORITY||Adjusted Risk Difference|20.3|||<|0.001|TWO_SIDED|95.0|13.6|27.1|||Cochran-Mantel-Haenszel|||||27.1|13.6|<0.001
72436390|NCT03105128|144386018|SUPERIORITY||Adjusted Risk Difference|21.9|||<|0.001|TWO_SIDED|95.0|13.8|29.9|||Cochran-Mantel-Haenszel|||||29.9|13.8|<0.001
72436391|NCT03105128|144386018|SUPERIORITY||Adjusted Risk Difference|18.8|||<|0.001|TWO_SIDED|95.0|10.8|26.8|||Cochran-Mantel-Haenszel|||||26.8|10.8|<0.001
72436392|NCT03105128|144386019|SUPERIORITY||Adjusted Risk Difference|28.3|||<|0.001|TWO_SIDED|95.0|21.2|35.4|||Cochran-Mantel-Haenszel|||||35.4|21.2|<0.001
72436393|NCT03105128|144386019|SUPERIORITY||Adjusted Risk Difference|20.3|||<|0.001|TWO_SIDED|95.0|13.6|27.1|||Cochran-Mantel-Haenszel|||||27.1|13.6|<0.001
72436394|NCT03105128|144386020|SUPERIORITY||Risk Difference (RD)|21.9|||<|0.001|TWO_SIDED|95.0|13.8|29.9|||Cochran-Mantel-Haenszel|||||29.9|13.8|<0.001
72436395|NCT03105128|144386020|SUPERIORITY||Adjusted Risk Difference|18.8|||<|0.001|TWO_SIDED|95.0|10.8|26.8|||Cochran-Mantel-Haenszel|||||26.8|10.8|<0.001
72436396|NCT03105128|144386021|SUPERIORITY||Adjusted Risk Difference|15.4|||<|0.001|TWO_SIDED|95.0|7.2|23.7|||Cochran-Mantel-Haenszel|||||23.7|7.2|<0.001
72436397|NCT03105128|144386021|SUPERIORITY||Adjusted Risk Difference|11.2||||0.007|TWO_SIDED|95.0|3.1|19.2|||Cochran-Mantel-Haenszel|||||19.2|3.1|0.007
72436398|NCT03105128|144386022|SUPERIORITY||Adjusted Risk Difference|23.1|||<|0.001|TWO_SIDED|95.0|14.2|31.9|||Cochran-Mantel-Haenszel|||||31.9|14.2|<0.001
72436399|NCT03105128|144386022|SUPERIORITY||Adjusted Risk Difference|27.7|||<|0.001|TWO_SIDED|95.0|19.0|36.4|||Cochran-Mantel-Haenszel|||||36.4|19.0|<0.001
72436400|NCT03105128|144386023|SUPERIORITY||Adjusted Risk Difference|5.2|||<|0.001|TWO_SIDED|95.0|3.2|7.2|||Cochran-Mantel-Haenszel|||||7.2|3.2|<0.001
72436401|NCT03105128|144386023|SUPERIORITY||Adjusted Risk Difference|4.1|||<|0.001|TWO_SIDED|95.0|2.1|6.1|||Cochran-Mantel-Haenszel|||||6.1|2.1|<0.001
72436402|NCT03105128|144386024|SUPERIORITY||Adjusted Risk Difference|7.6||||0.015|TWO_SIDED|95.0|1.5|13.7|||Cochran-Mantel-Haenszel|||||13.7|1.5|0.015
72436403|NCT03105128|144386024|SUPERIORITY||Adjusted Risk Difference|8.4||||0.007|TWO_SIDED|95.0|2.3|14.6|||Cochran-Mantel-Haenszel|||||14.6|2.3|0.007
72436404|NCT03105128|144386025|SUPERIORITY||Adjusted Risk Difference|24.5|||<|0.001|TWO_SIDED|95.0|18.5|30.5|||Cochran-Mantel-Haenszel|||||30.5|18.5|<0.001
72436405|NCT03105128|144386025|SUPERIORITY||Adjusted Risk Difference|17.3|||<|0.001|TWO_SIDED|95.0|11.8|22.9|||Cochran-Mantel-Haenszel|||||22.9|11.8|<0.001
72436406|NCT03105128|144386026|SUPERIORITY||Adjusted Risk Difference|24.2|||<|0.001|TWO_SIDED|95.0|15.7|32.7|||Cochran-Mantel-Haenszel|||||32.7|15.7|<0.001
72436407|NCT03105128|144386026|SUPERIORITY||Adjusted Risk Difference|23.6|||<|0.001|TWO_SIDED|95.0|15.1|32.1|||Cochran-Mantel-Haenszel|||||32.1|15.1|<0.001
72436408|NCT03105128|144386027|SUPERIORITY||Adjusted Risk Difference|21.2|||<|0.001|TWO_SIDED|95.0|12.4|30.0|||Cochran-Mantel-Haenszel|||||30.0|12.4|<0.001
72436409|NCT03105128|144386027|SUPERIORITY||Adjusted Risk Difference|19.0|||<|0.001|TWO_SIDED|95.0|10.1|27.8|||Cochran-Mantel-Haenszel|||||27.8|10.1|<0.001
72494634|NCT00662792|144518637|SUPERIORITY||Difference of adjusted means|0.0|STANDARD_ERROR_OF_MEAN|0.01||0.9956|TWO_SIDED|95.0|-0.03|0.03|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (Tio18GEL)|||0.03|-0.03|0.9956
72436410|NCT03105128|144386028|SUPERIORITY||Adjusted Risk Difference|15.1|||<|0.001|TWO_SIDED|95.0|9.0|21.2|||Cochran-Mantel-Haenszel|||||21.2|9.0|<0.001
72436411|NCT03105128|144386028|SUPERIORITY||Adjusted Risk Difference|15.4|||<|0.001|TWO_SIDED|95.0|9.4|21.4|||Cochran-Mantel-Haenszel|||||21.4|9.4|<0.001
72436412|NCT03105128|144386029|SUPERIORITY||Adjusted Risk Difference|14.9||||0.001|TWO_SIDED|95.0|6.2|23.5|||Cochran-Mantel-Haenszel|||||23.5|6.2|0.001
72436413|NCT03105128|144386029|SUPERIORITY||Adjusted Risk Difference|11.8||||0.007|TWO_SIDED|95.0|3.2|20.3|||Cochran-Mantel-Haenszel|||||20.3|3.2|0.007
72436414|NCT03105128|144386030|SUPERIORITY||Adjusted Risk Difference|13.7|||<|0.001|TWO_SIDED|95.0|7.9|19.5|||Cochran-Mantel-Haenszel|||||19.5|7.9|<0.001
72436415|NCT03105128|144386030|SUPERIORITY||Adjusted Risk Difference|9.1||||0.001|TWO_SIDED|95.0|3.7|14.5|||Cochran-Mantel-Haenszel|||||14.5|3.7|0.001
72436416|NCT03105128|144386031|SUPERIORITY||Adjusted Risk Difference|21.0|||<|0.001|TWO_SIDED|95.0|12.2|29.9|||Cochran-Mantel-Haenszel|||||29.9|12.2|<0.001
72436417|NCT03105128|144386031|SUPERIORITY||Adjusted Risk Difference|21.6|||<|0.001|TWO_SIDED|95.0|12.8|30.4|||Cochran-Mantel-Haenszel|||||30.4|12.8|<0.001
72436418|NCT03105128|144386032|SUPERIORITY||Adjusted Risk Difference|14.6||||0.022|TWO_SIDED|95.0|2.1|27.0|||Cochran-Mantel-Haenszel|||||27.0|2.1|0.022
72436419|NCT03105128|144386032|SUPERIORITY||Adjusted Risk Difference|23.7|||<|0.001|TWO_SIDED|95.0|11.1|36.3|||Cochran-Mantel-Haenszel|||||36.3|11.1|<0.001
72436420|NCT03105128|144386033|SUPERIORITY||Risk Difference (RD)|-8.7|||<|0.001|TWO_SIDED|95.0|-13.9|-3.5|||Chi-squared|||||-3.5|-13.9|<0.001
72436421|NCT03105128|144386033|SUPERIORITY||Risk Difference (RD)|-10.2|||<|0.001|TWO_SIDED|95.0|-15.2|-5.2|||Chi-squared|||||-5.2|-15.2|<0.001
72436422|NCT03105128|144386034|SUPERIORITY||Risk Difference (RD)|5.6||||1|TWO_SIDED|95.0|-28.6|39.7|||Chi-squared|||||39.7|-28.6|1.00
72436423|NCT03105128|144386034|SUPERIORITY||Risk Difference (RD)|6.9||||1|TWO_SIDED|25.0|-25.7|39.6|||Chi-squared|||||39.6|-25.7|1.000
72436424|NCT03105128|144386035|SUPERIORITY||Adjusted Risk Difference|20.7|||<|0.001|TWO_SIDED|95.0|12.4|29.0|||Cochran-Mantel-Haenszel|||||29.0|12.4|<0.001
72436425|NCT03105128|144386035|SUPERIORITY||Adjusted Risk Difference|16.7|||<|0.001|TWO_SIDED|95.0|8.5|24.9|||Cochran-Mantel-Haenszel|||||24.9|8.5|<0.001
72436426|NCT03105128|144386036|SUPERIORITY||Adjusted Risk Difference|15.4|||<|0.001|TWO_SIDED|95.0|7.2|23.7|||Cochran-Mantel-Haenszel|||||23.7|7.2|<0.001
72436427|NCT03105128|144386036|SUPERIORITY||Adjusted Risk Difference|11.2||||0.007|TWO_SIDED|95.0|3.1|19.2|||Cochran-Mantel-Haenszel|||||19.2|3.1|0.007
72436428|NCT03105128|144386037|SUPERIORITY||Adjusted Risk Difference|11.5|||<|0.001|TWO_SIDED|95.0|5.4|17.5|||Cochran-Mantel-Haenszel|||||17.5|5.4|<0.001
72436429|NCT03105128|144386037|SUPERIORITY||Adjusted Risk Difference|11.7|||<|0.001|TWO_SIDED|95.0|5.7|17.8|||Cochran-Mantel-Haenszel|||||17.8|5.7|<0.001
72436430|NCT03105128|144386038|SUPERIORITY||Adjusted Risk Difference|23.1|||<|0.001|TWO_SIDED|95.0|14.2|31.9|||Cochran-Mantel-Haenszel|||||31.9|14.2|<0.001
72436431|NCT03105128|144386038|SUPERIORITY||Adjusted Risk Difference|27.7|||<|0.001|TWO_SIDED|95.0|19.0|36.4|||Cochran-Mantel-Haenszel|||||36.4|19.0|<0.001
72436432|NCT03105128|144386039|SUPERIORITY||LS Mean Difference|5.2|||<|0.001|TWO_SIDED|95.0|3.2|7.2|||Mixed-Effect Model Repeat Measurement|||||7.2|3.2|<0.001
72436433|NCT03105128|144386039|SUPERIORITY||LS Mean Difference|4.1|||<|0.001|TWO_SIDED|95.0|2.1|6.1|||Mixed-Effect Model Repeat Measurement|||||6.1|2.1|<0.001
72436434|NCT03105128|144386040|SUPERIORITY||LS Mean Difference|20.7|||<|0.001|TWO_SIDED|95.0|14.3|27.1|||Mixed-Effect Model Repeat Measurement|||||27.1|14.3|<0.001
72436435|NCT03105128|144386040|SUPERIORITY||LS Mean Difference|19.4|||<|0.001|TWO_SIDED|95.0|13.1|25.8|||Mixed-Effect Model Repeat Measurement|||||25.8|13.1|<0.001
72436436|NCT03105128|144386041|SUPERIORITY||Adjusted Risk Difference|23.2|||<|0.001|TWO_SIDED|95.0|16.8|29.6|||Cochran-Mantel-Haenszel|||||29.6|16.8|<0.001
72436437|NCT03105128|144386041|SUPERIORITY||Adjusted Risk Difference|15.2|||<|0.001|TWO_SIDED|95.0|9.3|21.2|||Cochran-Mantel-Haenszel|||||21.2|9.3|<0.001
72436438|NCT03105128|144386042|SUPERIORITY||Adjusted Risk Difference|15.1|||<|0.001|TWO_SIDED|95.0|9.0|21.2|||Cochran-Mantel-Haenszel|||||21.2|9.0|<0.001
72436439|NCT03105128|144386042|SUPERIORITY||Adjusted Risk Difference|15.4|||<|0.001|TWO_SIDED|95.0|9.4|21.4|||Cochran-Mantel-Haenszel|||||21.4|9.4|<0.001
72436440|NCT03105128|144386043|SUPERIORITY||Adjusted Risk Difference|14.9||||0.001|TWO_SIDED|95.0|6.2|23.5|||Cochran-Mantel-Haenszel|||||23.5|6.2|0.001
72494635|NCT00662792|144518637|SUPERIORITY||Difference of adjusted means|-0.01|STANDARD_ERROR_OF_MEAN|0.01||0.71|TWO_SIDED|95.0|-0.03|0.02|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (Salm50DPI)|||0.02|-0.03|0.7100
72558331|NCT00841659|144646254|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of LS Means x 100|94.29||||||90.0|||||||Bioequivalence is established when ratio of means falls within 80-125.|||||
72436441|NCT03105128|144386043|SUPERIORITY||Adjusted Risk Difference|11.8||||0.007|TWO_SIDED|95.0|3.2|20.3|||Cochran-Mantel-Haenszel|||||20.3|3.2|0.007
72436442|NCT03105128|144386044|SUPERIORITY||Adjusted Risk Difference|13.7|||<|0.001|TWO_SIDED|95.0|7.9|19.5|||Cochran-Mantel-Haenszel|||||19.5|7.9|<0.001
72494636|NCT00662792|144518637|SUPERIORITY||Difference of adjusted means|0.01|STANDARD_ERROR_OF_MEAN|0.01||0.3659|TWO_SIDED|95.0|-0.02|0.04|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (T18GEL+S-DPI)|||0.04|-0.02|0.3659
72494637|NCT00662792|144518638|SUPERIORITY||Difference of adjusted means|-0.01|STANDARD_ERROR_OF_MEAN|0.01||0.4416|TWO_SIDED|95.0|-0.04|0.02|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (Tio18GEL)|||0.02|-0.04|0.4416
72494638|NCT00662792|144518638|SUPERIORITY||Difference of adjusted means|-0.01|STANDARD_ERROR_OF_MEAN|0.01||0.7058|TWO_SIDED|95.0|-0.03|0.02|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (Salm50DPI)|||0.02|-0.03|0.7058
72494639|NCT00662792|144518638|SUPERIORITY||Difference of adjusted means|0.02|STANDARD_ERROR_OF_MEAN|0.01||0.1494|TWO_SIDED|95.0|-0.01|0.05|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (T18GEL+S-DPI)|||0.05|-0.01|0.1494
72494640|NCT00662792|144518639|SUPERIORITY||Difference of adjusted means|0.0|STANDARD_ERROR_OF_MEAN|0.03||0.998|TWO_SIDED|95.0|-0.06|0.06|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (Tio18GEL)|||0.06|-0.06|0.9980
72494641|NCT00662792|144518639|SUPERIORITY||Difference of adjusted means|0.02|STANDARD_ERROR_OF_MEAN|0.03||0.4618|TWO_SIDED|95.0|-0.04|0.08|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (Salm50DPI)|||0.08|-0.04|0.4618
72494642|NCT00662792|144518639|SUPERIORITY||Difference of adjusted means|0.06|STANDARD_ERROR_OF_MEAN|0.03||0.0418|TWO_SIDED|95.0|0.0|0.12|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (T18GEL+S-DPI)|||0.12|0.00|0.0418
72558332|NCT02054715|144646255|OTHER||Mean Difference (MP - PE)|-0.1|STANDARD_ERROR_OF_MEAN|2.0||0.9621|TWO_SIDED|95.0|-4.1|3.9|||F-Test|||Two-sided F-Test as a statistical comparing MP and PE means.||3.9|-4.1|0.9621
72558333|NCT02054715|144646256|OTHER||Mean Difference (MP - PE)|0.18|STANDARD_ERROR_OF_MEAN|1.57||0.9065|TWO_SIDED|95.0|-2.89|3.26|||F-test|||Two-sided F-Test comparing the MP and PE means.||3.26|-2.89|0.9065
72436443|NCT03105128|144386044|SUPERIORITY||Adjusted Risk Difference|9.1||||0.001|TWO_SIDED|95.0|3.7|14.5|||Cochran-Mantel-Haenszel|||||14.5|3.7|0.001
72558334|NCT02054715|144646257|OTHER||Mean Difference (MP - PE)|-0.05|STANDARD_ERROR_OF_MEAN|1.4||0.9709|TWO_SIDED|95.0|-2.79|2.69|||F-Test|||Two-sided F-Test comparing the MP and PE means.||2.69|-2.79|0.9709
72436444|NCT03105128|144386045|SUPERIORITY||Adjusted Risk Difference|21.0|||<|0.001|TWO_SIDED|95.0|12.2|29.9|||Cochran-Mantel-Haenszel|||||29.9|12.2|<0.001
72436445|NCT03105128|144386045|SUPERIORITY||Adjusted Risk Difference|21.6|||<|0.001|TWO_SIDED|95.0|12.8|30.4|||Cochran-Mantel-Haenszel|||||30.4|12.8|<0.001
72436446|NCT03105128|144386046|SUPERIORITY||Adjusted Risk Difference|14.6||||0.022|TWO_SIDED|95.0|2.1|27.0|||Cochran-Mantel-Haenszel|||||27.0|2.1|0.022
72436447|NCT03105128|144386046|SUPERIORITY||Adjusted Risk Difference|23.7|||<|0.001|TWO_SIDED|95.0|11.1|36.3|||Cochran-Mantel-Haenszel|||||36.3|11.1|<0.001
72436448|NCT03105128|144386047|SUPERIORITY||LS Mean Difference|-8.7|||<|0.001|TWO_SIDED|95.0|-13.9|-3.5|||Mixed-Effect Model Repeat Measurement|||||-3.5|-13.9|<0.001
72436449|NCT03105128|144386047|SUPERIORITY||LS Mean Difference|-10.2|||<|0.001|TWO_SIDED|95.0|-15.2|-5.2|||Mixed-Effect Model Repeat Measurement|||||-5.2|-15.2|<0.001
72494643|NCT00662792|144518640|SUPERIORITY||Difference of adjusted means|-0.02|STANDARD_ERROR_OF_MEAN|0.03||0.4206|TWO_SIDED|95.0|-0.08|0.03|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (Tio18GEL)|||0.03|-0.08|0.4206
72494644|NCT00662792|144518640|SUPERIORITY||Difference of adjusted means|0.0|STANDARD_ERROR_OF_MEAN|0.03||0.8723|TWO_SIDED|95.0|-0.05|0.06|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (Salm50DPI)|||0.06|-0.05|0.8723
72494645|NCT00662792|144518640|SUPERIORITY||Difference of adjusted means|0.05|STANDARD_ERROR_OF_MEAN|0.03||0.1005|TWO_SIDED|95.0|-0.01|0.11|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (T18GEL+S-DPI)|||0.11|-0.01|0.1005
72494646|NCT00441545|144518656|SUPERIORITY_OR_OTHER_LEGACY|||||||0.113||95.0|||||ANCOVA|||||||0.1130
72494647|NCT00441545|144518657|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0249||95.0|||||ANCOVA|||||||0.0249
72494648|NCT02347176|144518660|SUPERIORITY||Adjusted Mean Difference|-2.89|STANDARD_ERROR_OF_MEAN|1.968||0.143|TWO_SIDED|95.0|-6.78|0.99|||Mixed Model Repeated Measures Analysis|||||0.99|-6.78|0.143
72494649|NCT02347176|144518660|SUPERIORITY||Adjusted Mean Difference|-4.36|STANDARD_ERROR_OF_MEAN|1.951||0.027|TWO_SIDED|95.0|-8.22|-0.51|||Mixed Model Repeated Measures Analysis|||||-0.51|-8.22|0.027
72494650|NCT02347176|144518660|SUPERIORITY||Adjusted Mean Difference|-4.94|STANDARD_ERROR_OF_MEAN|1.932||0.011|TWO_SIDED|95.0|-8.76|-1.13|||Mixed Model Repeated Measures Analysis|||||-1.13|-8.76|0.011
72494651|NCT02347176|144518661|SUPERIORITY||Odds Ratio (OR)|0.98||||0.974|TWO_SIDED|95.0|0.29|3.32|||Regression, Logistic|||||3.32|0.29|0.974
72494652|NCT02347176|144518661|SUPERIORITY||Odds Ratio (OR)|1.85||||0.281|TWO_SIDED|95.0|0.61|5.65|||Regression, Logistic|||||5.65|0.61|0.281
72494653|NCT02347176|144518661|SUPERIORITY||Odds Ratio (OR)|2.83||||0.061|TWO_SIDED|95.0|0.95|8.37|||Regression, Logistic|||||8.37|0.95|0.061
72494654|NCT00523991|144518759|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.23|||<|0.001||95.0|0.18|0.27||"There was only one primary endpoint and the p-value was not adjusted for multiple comparisons.~Mean Difference (Final Values) means difference in LS-Means"|ANCOVA|The analysis of covariance model included treatment, site, and trough forced expiratory volume in 1 second at baseline in the model.||||0.27|0.18|<0.001
72558335|NCT02054715|144646258|OTHER|||||||0.014|||||||Chi-squared|||Chi-square test between MP and PE. 69% of subjects that got the Multimedia Psychoeducation intervention chose to participate in a clinical trial, compared with 62% in the Print Education group||||0.014
72558336|NCT00073307|144646263|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.88||||0.146||95.0|0.74|1.04||According to O'Brien-Fleming type alpha spending function and total actual deaths at final analysis, threshold for statistical significance was alpha=0.037 (two-sided).|Log Rank||Two treatment groups compared using log-rank test (Sorafenib over Placebo) stratified by country and Motzer category|Sample size based on primary efficacy endpoint of OS. Clinically meaningful improvement defined as 33.3% improvement in median OS (i.e. HR of 0.75, Sorafenib over Placebo). With overall two-sided alpha of 0.04, 90% power and randomization of 1:1, two formal interim analyses and one final analysis were planned using O'Brien-Fleming type error spending function, and a total of approximately 540 events (deaths) were required for the final analysis.||1.04|0.74|0.146
72558337|NCT00073307|144646264|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.78||||0.0287||95.0|0.62|0.97||According to O'Brien-Fleming type alpha spending function and total actual deaths at final analysis, threshold for statistical significance was alpha=0.037 (two-sided).|Log Rank||Two treatment groups compared using log-rank test (Sorafenib over Placebo) stratified by country and Motzer category|Sample size based on primary efficacy endpoint of OS. Clinically meaningful improvement defined as 33.3% improvement in median OS (i.e. HR of 0.75, Sorafenib over Placebo). With overall two-sided alpha of 0.04, 90% power and randomization of 1:1, two formal interim analyses and one final analysis were planned using O'Brien-Fleming type error spending function, and a total of approximately 540 events (deaths) were required for the final analysis.||0.97|0.62|0.0287
72618758|NCT01026038|144768112|SUPERIORITY_OR_OTHER||Percent Difference|0.0|||||TWO_SIDED|95.0|-3.6|6.5||||||Serotype 4: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 13vPnC/13vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/13vPnC/13vPnC along with exact 2-sided 95% CI.||6.5|-3.6|
72436450|NCT03105128|144386048|SUPERIORITY||LS Mean Difference|5.6||||1|TWO_SIDED|95.0|-28.6|39.7|||Mixed-Effect Model Repeat Measurement|||||39.7|-28.6|1.000
72436451|NCT03105128|144386048|SUPERIORITY||LS Mean Difference|6.9||||1|TWO_SIDED|95.0|-25.7|39.6|||Mixed-Effect Model Repeat Measurement|||||39.6|-25.7|1.000
72436452|NCT03105128|144386049|SUPERIORITY||LS Mean Difference|-9.586||||0.024|TWO_SIDED|95.0|-17.89|-1.282|||Mixed-Effect Model Repeat Measurement|||||-1.282|-17.890|0.024
72436453|NCT03105128|144386049|SUPERIORITY||LS Mean Difference|-12.141||||0.004|TWO_SIDED|95.0|-20.39|-3.892|||Mixed-Effect Model Repeat Measurement|||||-3.892|-20.390|0.004
72436454|NCT03105128|144386050|SUPERIORITY||LS Mean Difference|2.913|||<|0.001|TWO_SIDED|95.0|1.512|4.313|||Mixed-Effect Model Repeat Measurement|||||4.313|1.512|<0.001
72436455|NCT03105128|144386050|SUPERIORITY||LS Mean Difference|3.275|||<|0.001|TWO_SIDED|95.0|1.877|4.672|||Mixed-Effect Model Repeat Measurement|||||4.672|1.877|<0.001
72436456|NCT00387465|144386061|OTHER|The maximum tolerated dose (MTD) was derived from the number of participants experiencing dose-limiting toxicities in the Phase I arms. The MTD was the dose at which ≤30% of patients experienced DLTs during cycle 1 up to a pre-specified maximal dose of 40 mg/m2 of azacitidine.|Maximum Tolerated Dose|40.0|||||TWO_SIDED||||||||MTD of Azacitidine measured in mg/m\^2|||||
72436457|NCT00482729|144386119|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.6|||<|0.001||95.0|-0.78|-0.43|||ANCOVA|Model terms: treatment, baseline A1C||||-0.43|-0.78|<0.001
72436458|NCT00482729|144386120|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.07|||<|0.001||95.0|1.6|2.69||Based on a test of the odds ratio = 1, comparing the odds of having A1C \<7.0% at Week 18 in the Sita/Met FDC group vs. the Metformin group.|ANCOVA|Model terms: treatment, baseline A1C|This parameter estimate and 95% confidence interval correspond to the odds of having A1C \<7.0% at Week 18 in the Sita/Met FDC group vs. the Metformin group.|||2.69|1.60|<0.001
72436459|NCT00482729|144386121|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-15.7|||<|0.001||95.0|-22.4|-9.0|||ANCOVA|Model terms: treatment, baseline A1C||||-9.0|-22.4|<0.001
72436460|NCT00482729|144386122|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.48||||||95.0|-0.67|-0.3|||||This is a difference in least squares means, based on an ANCOVA model with terms for treatment and baseline (i.e., Week 0) A1C.|||-0.30|-0.67|
72436461|NCT00482729|144386123|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.11||||||95.0|1.63|2.73|||||This parameter estimate and 95% confidence interval correspond to the odds of having A1C \<7.0% at Week 44 in the Sita/Met FDC group vs. the Metformin group, based on a logistic regression model with terms for treatment and baseline (i.e., Week 0) A1C|||2.73|1.63|
72436462|NCT01606124|144386124|SUPERIORITY|||||||0.5631|||||||Wilcoxon (Mann-Whitney)|||||||0.5631
72436463|NCT01606124|144386125|SUPERIORITY|||||||0.1439|||||||Wilcoxon (Mann-Whitney)|||||||0.1439
72436464|NCT00955825|144386185|SUPERIORITY_OR_OTHER||LS Mean difference vs. Placebo|-0.126||||0.0003||95.0|-0.194|-0.058|||ANCOVA||Relative LS Means difference (%) = - 28.24|||-0.058|-0.194|0.0003
72436465|NCT01499134|144386186|SUPERIORITY_OR_OTHER|||||||0.039|||||||Wilcoxon (Mann-Whitney)|||||||0.039
72618759|NCT01026038|144768112|SUPERIORITY_OR_OTHER||Percent Difference|0.0|||||TWO_SIDED|95.0|-6.8|6.6||||||Serotype 4: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 7vPnC/7vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/13vPnC/13vPnC along with exact 2-sided 95% CI.||6.6|-6.8|
72436466|NCT01499134|144386187|SUPERIORITY_OR_OTHER|||||||0.585|||||||Wilcoxon (Mann-Whitney)|||||||0.585
72436467|NCT01499134|144386188|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED|||||This p-value is correct, confirmed with report from statistician.|Wilcoxon (Mann-Whitney)|||||||1.000
72436468|NCT01499134|144386189|SUPERIORITY_OR_OTHER|||||||0.363|||||||Wilcoxon (Mann-Whitney)|||||||0.363
72436469|NCT01499134|144386190|SUPERIORITY_OR_OTHER|||||||0.017|||||||Wilcoxon (Mann-Whitney)|||||||0.017
72436470|NCT01499134|144386191|SUPERIORITY_OR_OTHER|||||||0.476|||||||Wilcoxon (Mann-Whitney)|||||||0.476
72436471|NCT01499134|144386192|SUPERIORITY_OR_OTHER|||||||0.17|||||||Wilcoxon (Mann-Whitney)|||||||0.170
72436472|NCT01499134|144386193|SUPERIORITY_OR_OTHER|||||||0.595|||||||Wilcoxon (Mann-Whitney)|||||||0.595
72494655|NCT00523991|144518763|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.14|||<|0.001||95.0|0.09|0.18||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|Terms include treatment, site, and trough forced expiratory volume in 1 second at baseline Mean Difference (Final Values) means difference in LSMeans||tiotropium versus placebo||0.18|0.09|<0.001
72494656|NCT00523991|144518767|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.24|||<|0.001||95.0|0.19|0.29||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|Terms include treatment, site, and peak forced expiratory volume in 1 second at baseline Mean Difference (Final Values) means difference in LSMeans||tiotropium versus placebo||0.29|0.19|<0.001
72494657|NCT00523991|144518783|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.14|||<|0.001||95.0|0.09|0.18||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"Terms include treatment, site, and forced expiratory volume in 1 second at baseline~Mean Difference (Final Values) means difference in LSMeans"||tiotropium versus placebo||0.18|0.09|<0.001
72494658|NCT00523991|144518784|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2|||<|0.001||95.0|0.16|0.25||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms include treatment, site, and forced expiratory volume in 1 second at baseline~Mean Difference (Final Values) means difference in LSMeans"||tiotropium versus placebo||0.25|0.16|<0.001
72494659|NCT00523991|144518785|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.23|||<|0.001||95.0|0.18|0.28||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms include treatment, site, and forced expiratory volume in 1 second at baseline~Mean Difference (Final Values) means difference in LSMeans"||tiotropium vesus placebo||0.28|0.18|<0.001
72494660|NCT00523991|144518786|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.24|||<|0.001||95.0|0.2|0.29||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms include treatment, site, and forced expiratory volume in 1 second at baseline~Mean Difference (Final Values) means difference in LSMeans"||tiotropium versus placebo||0.29|0.20|<0.001
72494661|NCT00523991|144518787|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.25|||<|0.001||95.0|0.2|0.3||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms include treatment, site, and peak forced expiratory volume in 1 second at baseline~Mean Difference (Final Values) means difference in LSMeans"||tiotropium versus placebo||0.30|0.20|<0.001
72494662|NCT00523991|144518791|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.31|||<|0.001||95.0|0.24|0.38||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|terms include treatment, site, and forced vital capacity area under the curve at baseline Mean Difference (Final Values) means difference in LSMeans||tiotropium versus placebo||0.38|0.24|<0.001
72494663|NCT00523991|144518795|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.21|||<|0.001||95.0|0.14|0.28||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms include treatment, site, and trough forced vital capacity at baseline~Mean Difference (Final Values) means difference in LSMeans"||tiotropium versus placebo||0.28|0.14|<0.001
72558338|NCT00073307|144646265|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.44|||<|1e-06||95.0|0.35|0.55|||Log Rank||Two treatment groups compared using log-rank test (Sorafenib over Placebo) stratified by country and Motzer category|The planned final PFS analysis was to be performed when approximately 363 progressions or deaths (if death occurred before progression) were observed. The analysis had power of 90% to detect a 50% increase in PFS using a two-sided alpha of 0.01||0.55|0.35|<0.000001
72436473|NCT01198275|144386195|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.441|||<|0.05|TWO_SIDED|95.0|0.292|0.666|||Kaplan Meyer analysis|The time to first AF recurrence was analyzed with the Kaplan-Meier method and compared with the log-rank test.|Hazard ratios between n-3 PUFA and Placebo together with confidence intervals were estimated using the Cox proportional regression model.|Give a relapse rate ranging from 40% to 60% on ACE-I/ARB and amiodarone therapy, considering the high risk of relapses in our study population we conservatively assumed a 50% relapse rate. We calculated that a total of 180 patients would yield 80% power to detect a clinically relevant difference of about 20% in AF recurrence with the addition of n-3 PUFAs at a log-rank test, with a significance level of 0.05.||0.666|0.292|< 0.05
72436474|NCT02729701|144386207|OTHER|||||||0.017||||||a priori threshold for statistical significance \<0.05|Wilcoxon (Mann-Whitney)|||Test for within-group change by paired two-sample non-parametric test||||0.017
72436475|NCT02729701|144386208|OTHER|||||||0.043||||||a priori threshold for statistical significance \<0.05|Wilcoxon (Mann-Whitney)|2-sided||Test for within-group change via paired, two-sample non-parametric test||||0.043
72436476|NCT02729701|144386209|OTHER|||||||0.088||||||a priori threshold for statistical significance \< 0.05|Wilcoxon (Mann-Whitney)|||Test for within-group change using paired two-sample non-parametric etst||||0.088
72436477|NCT00738699|144386248|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.13||||0.836|TWO_SIDED|95.0|0.88|1.46||One-sided log rank test stratified by route of administration for primary chemotherapy (intraperitoneal vs intravenous) and geographic region (North America, Europe, and other participating countries).|Log Rank||Stratified as described above.|||1.46|0.88|0.8360
72494664|NCT00523991|144518799|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.33|||<|0.001||95.0|0.24|0.42||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms include treatment, site, and peak forced vital capacity at baseline~Mean Difference (Final Values) means difference in LSMeans"||tiotropium versus placebo||0.42|0.24|<0.001
72494665|NCT00523991|144518815|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.21|||<|0.001||95.0|0.14|0.28||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|terms include treatment, site, and forced vital capacity at baseline Mean Difference (Final Values) means difference in LSMeans||tiotropium versus placebo||0.28|0.14|<0.001
72494666|NCT00523991|144518816|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.29|||<|0.001||95.0|0.21|0.36||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms include treatment, site, and forced vital capacity at baseline~Mean Difference (Final Values) means difference in LSMeans"||tiotropium versus placebo||0.36|0.21|<0.001
72494667|NCT00523991|144518817|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3|||<|0.001||95.0|0.23|0.38||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|terms include treatment, site, and forced vital capacity at baseline Mean Difference (Final Values) means difference in LSMeans||tiotropium versus placebo||0.38|0.23|<0.001
72558339|NCT00073307|144646266|SUPERIORITY_OR_OTHER||Difference in response rates (CR+PR)|-2.1||||||95.0|-3.7|-0.6|||Cochran-Mantel-Haenszel|Adjustments for country and Motzer category|difference in response rates (CR+PR) = Placebo - Sorafenib|||-0.6|-3.7|
72384337|NCT04399837|144276351|SUPERIORITY|Null hypothesis: Effect of spesolimab 300 mg every 12 weeks on prolonging the time to the first GPP flare up to week 48 ≤ Placebo.|Hazard Ratio (HR)|0.468||||0.0269|TWO_SIDED|95.0|0.206|1.064||"One-sided p-value was computed from the log-rank test stratified by use of systemic GPP medication at randomisation.~Threshold for statistical significance: one-sided p-value ≤ 0.01875."|Log Rank||Hazard ratio and its 95% Confidence Interval are from Cox regression model stratified by use of systemic GPP medication at randomisation.|||1.064|0.206|0.0269
72384338|NCT04399837|144276351|SUPERIORITY|Null hypothesis: Effect of spesolimab 300 mg every 4 weeks on prolonging the time to the first GPP flare up to week 48 ≤ Placebo.|Hazard Ratio (HR)|0.157||||0.0005|TWO_SIDED|95.0|0.046|0.541||"One-sided p-value is computed from the log-rank test stratified by use of systemic GPP medication at randomisation.~Threshold for statistical significance: One-sided p-value ≤0.0125."|Log Rank||Hazard ratio and its 95% CI (confidence interval) are from Cox regression model stratified by use of systemic GPP medication at randomisation.|||0.541|0.046|0.0005
72384339|NCT04399837|144276352|SUPERIORITY|Null hypothesis: The proportion of patients who do not experience a GPP flare up to week 48 on BI 655130 300 mg every 4 weeks ≤ Placebo.|Risk Difference (RD)|-0.39||||0.0013|TWO_SIDED|95.0|-0.621|-0.159||"One-sided p-value was computed from the Cochran-Mantel-Haenszel test stratified by use of systemic GPP medication at randomisation.~one-sided alpha= 0.00625"|Cochran-Mantel-Haenszel||Risk difference=Spesolimab high dose-Placebo.|||-0.159|-0.621|0.0013
72384340|NCT04399837|144276353|SUPERIORITY|Null hypothesis: Effect of BI 655130 300 mg every 4 weeks on prolonging the time to first worsening of PSS up to week 48 ≤ Placebo.|Hazard Ratio (HR)|0.424||||0.0134|TWO_SIDED|95.0|0.197|0.914||"One-sided p-value was computed from the log-rank test stratified by use of systemic GPP medication at randomisation.~one-sided alpha= 0.00625"|Log Rank||spesolimab high dose vs. Placebo|Hazard ratio and its 95% CI (confidence interval) are from Cox regression model stratified by use of systemic GPP medication at randomisation.||0.914|0.197|0.0134
72384341|NCT04399837|144276354|SUPERIORITY|Null hypothesis: Effect of BI 655130 300 mg every 4 weeks on prolonging the time to the first worsening of DLQI up to week 48 ≤ Placebo.|Hazard Ratio (HR)|0.259||||0.001|TWO_SIDED|95.0|0.109|0.62||One sided p-value was computed from the log-rank test stratified by use of systemic GPP medication at randomisation.|Log Rank||spesolimab high dose vs. Placebo|"Hazard ratio and its 95% CI (confidence interval) are from Cox regression model stratified by use of systemic GPP medication at randomisation.~one-sided alpha= 0.00625"||0.620|0.109|0.0010
72384342|NCT01532973|144276357|SUPERIORITY_OR_OTHER||Difference in LS Means|4.26|||||TWO_SIDED|90.0|3.77|4.74||||||||4.74|3.77|
72384343|NCT01532973|144276357|SUPERIORITY_OR_OTHER||Difference in LS Means|4.41|||||TWO_SIDED|90.0|3.92|4.9||||||||4.90|3.92|
72436478|NCT00738699|144386249|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.11||||0.7568|TWO_SIDED|95.0|0.83|1.48||One-sided log rank test stratified by route of administration for primary chemotherapy and geographic region.|Log Rank||Stratified as described above|||1.48|0.83|0.7568
72436479|NCT00738699|144386250|SUPERIORITY_OR_OTHER||Difference|-7.4||||0.0399|TWO_SIDED|95.0|-14.1|-0.7||Compared the ratio of complete or partial responders in the two arms. Stratified by route of administration for first line therapy and geographic region as specified at baseline.|Cochran-Mantel-Haenszel||(FAR + Paclitaxel) minus (Placebo + Paclitaxel). Confidence interval based on a normal approximation to the binomial distribution.|||-0.7|-14.1|0.0399
72436480|NCT00549848|144386271|SUPERIORITY|||||||0.778|||||||Cochran-Mantel-Haenszel|||||||0.778
72436481|NCT03262935|144386277|SUPERIORITY||Hazard Ratio (HR)|0.6401|||=|0.002|TWO_SIDED|95.0|0.4885|0.8389||P-value from stratified log-rank test for median estimate of PFS: stratified according to the randomization stratification factors.|Log Rank|||A stratified Cox regression analysis was used to estimate the hazard ratio of PFS, along with 95% CIs. Stratification factors assigned at randomization were world region (Europe, Singapore, and North America), number of prior treatment lines for locally advanced or metastatic breast cancer (excluding hormone therapy) (1 to 2, \>2), and prior treatment with pertuzumab (yes, no).||0.8389|0.4885|=0.002
72436482|NCT03262935|144386278|SUPERIORITY||Hazard Ratio (HR)|0.868|||=|0.236|TWO_SIDED|95.0|0.676|1.1145||P-value from stratified log-rank test for Kaplan-Meier estimate of median OS: stratified according to the randomization stratification factors.|Log Rank|||A stratified Cox regression analysis was used to estimate the hazard ratio of OS, along with 95% CIs. Stratification factors assigned at randomization were world region (Europe, Singapore, and North America), number of prior treatment lines for locally advanced or metastatic breast cancer (excluding hormone therapy) (1 to 2, \>2), and prior treatment with pertuzumab (yes, no).||1.1145|0.676|=0.236
72436483|NCT03262935|144386279|SUPERIORITY||||||=|0.732||||||P-value from Cochran-Mantel-Haenszel test including the randomization stratification factors.|Cochran-Mantel-Haenszel|||The Cochran-Mantel-Haenszel test (strata based on the baseline stratification factors) was used to compare the two treatment groups with respect to the ORR at two-sided 5% level of significance.||||=0.732
72558340|NCT00073307|144646267|SUPERIORITY_OR_OTHER|||||||0.98|||||||random coefficient model|Random coefficient model adjusted for baseline Motzer score, baseline FKSI-10 score and relative day of FKSI-10 completion.||Approximately 200 subjects per group, assuming a 10% drop out rate, were required to detect a 2 point difference between sorafenib and placebo at approximately 80% power with a two-sided alpha of 0.05||||0.98
72384344|NCT01532973|144276357|SUPERIORITY_OR_OTHER||Difference in LS Means|3.56|||||TWO_SIDED|90.0|3.08|4.05||||||||4.05|3.08|
72384345|NCT01532973|144276358|SUPERIORITY_OR_OTHER||Difference in LS Means|1.02|||||TWO_SIDED|90.0|0.34|1.69||||||||1.69|0.34|
72384346|NCT01532973|144276358|SUPERIORITY_OR_OTHER||Difference in LS Means|2.07|||||TWO_SIDED|90.0|1.39|2.74||||||||2.74|1.39|
72384347|NCT01532973|144276358|SUPERIORITY_OR_OTHER||Difference in LS Means|2.72|||||TWO_SIDED|90.0|2.05|3.39||||||||3.39|2.05|
72384348|NCT01532973|144276359|SUPERIORITY_OR_OTHER||Difference in LS Means|3.2|||||TWO_SIDED|90.0|2.68|3.72||||||||3.72|2.68|
72436484|NCT03262935|144386280|SUPERIORITY||Hazard Ratio (HR)|0.5995|||<|0.001|TWO_SIDED|95.0|0.4666|0.7703||P-value from stratified log-rank test for median estimate of PFS: stratified according to the randomization stratification factors.|Log Rank|||A stratified Cox regression analysis was used to estimate the HR of PFS, along with the 95% CI. The treatment groups were compared using the 2-sided stratified log-rank test.||0.7703|0.4666|<0.001
72436485|NCT03262935|144386281|SUPERIORITY|||||||0.473|||||||MMRM|||The change from baseline in the global health status/QoL scale transformed score was analyzed using a mixed model repeated measurement (MMRM) approach.||||0.473
72436486|NCT01811706|144386286|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||t-test, 2 sided|||Null hypothesis is that there was no difference in change of T25FW between Dalfampridine and Placebo. The test was performed with a significant level of 0.05 (two-sided).||||>0.05
72436487|NCT01811706|144386287|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||t-test, 2 sided|||Null hypothesis is that there was no difference in change of SARA score between Dalfampridine and Placebo. The test was performed with a significant level of 0.05 (two-sided).||||>0.05
72436488|NCT01811706|144386288|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||t-test, 2 sided|||Null hypothesis is that there was no difference in change of Stride Length on BAG between Dalfampridine and Placebo. The test was performed with a significant level of 0.05 (two-sided).||||>0.05
72436489|NCT01192542|144386376|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin of 0.05 (1/2 LogMAR line) was used.|Least-square mean difference|-0.009|STANDARD_ERROR_OF_MEAN|0.0064|||TWO_SIDED|95.0|-0.022|0.003|||Mixed Models Analysis|Comparisons between two lenses were carried out using 95% confidence intervals (CI) constructed for least-square mean differences.|The mean difference is calculated as: Test lens - Control lens.|The alternative hypothesis is the monocular visual acuity of the galyfilcon A prototype lens is non-inferior to that of the enfilcon A lens.||0.003|-0.022|
72436490|NCT01192542|144386379|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin of 0.05 (1/2 LogMAR line) was used.|Least-square mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.0091|||TWO_SIDED|95.0|-0.018|0.018|||Mixed Models Analysis|Comparisons between two lenses were carried out using 95% confidence intervals (CI) constructed for least-square mean differences.||The alternative hypothesis is the binocular visual acuity of the galyfilcon A prototype lens is non-inferior to that of the enfilcon A lens.||0.018|-0.018|
72436491|NCT00964366|144386380|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Dunn's Multiple Comparisons Test|||||||> 0.05
72436492|NCT00964366|144386382|SUPERIORITY_OR_OTHER||||||<|0.05||||||Dapsone versus Clindamycin/BPO gel.|Dunn's Multiple Comparisons Test|||||||< 0.05
72436493|NCT00964366|144386383|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||||||>0.05
72436494|NCT00964366|144386384|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||||||>0.05
72494668|NCT00523991|144518818|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.33|||<|0.001||95.0|0.25|0.4||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|terms include treatment, site, and forced vital capacity at baseline Mean Difference (Final Values) means difference in LSMeans||tiotropium versus placebo||0.40|0.25|<0.001
72558341|NCT00073307|144646268|SUPERIORITY_OR_OTHER|||||||0.83|||||||random coefficient model|Random coefficient model adjusted for baseline Motzer score, baseline PWB score and relative day of PWB completion.||Approximately 200 subjects per group, assuming a 10% drop out rate, were required to detect a 2 point difference between sorafenib and placebo at approximately 80% power with a two-sided alpha of 0.05||||0.83
72436495|NCT02393716|144386392|OTHER|Single arm study with a hypothesis test comparing to performance goal|Percentage|2.9|||<|0.001|ONE_SIDED|97.5||7.2|||Based on exact binomial distribution|||"The primary safety endpoint was tested against a predetermined safety Performance Goal (PG) using the following statistical hypotheses:~H0: p ≥ 20% vs. H1: p \< 20% where p is the proportion of subjects experiencing a MAE within 30 days of the index procedure in the target population of subjects treated with the Endurant Evo AAA Stent graft system and 20% is the safety PG."||7.2||<0.001
72436496|NCT02393716|144386393|OTHER|Single-arm study with a hypothesis test comparing to performance goal|Percentage|95.8|||<|0.001|ONE_SIDED|97.5|90.4||||Based on exact binomial distribution|||"The primary effectiveness endpoint was tested against a predetermined effectiveness PG using following statistical hypotheses:~H0: q ≤ 80% vs. H1: q \> 80% where q is the proportion of subjects who have a successful aneurysm treatment in the target population of subjects treated with the Endurant Evo AAA Stent graft system and 80% is the effectiveness PG."|||90.4|<0.001
72436497|NCT02957539|144386407|SUPERIORITY||Mean Difference (Net)|-4.5|||||TWO_SIDED|97.5|-10.7|1.6|||||Change in weight from baseline to week 32 in the financial rewards arm minus the change in weight from baseline to week 32 in the no rewards arm.|||1.6|-10.7|
72436498|NCT02957539|144386407|SUPERIORITY||Mean Difference (Net)|-5.0|||<|0.025|TWO_SIDED|97.5|-11.1|1.0|||t-test, 2 sided||Change in weight from baseline to week 32 in the non-financial arm minus the change in weight from baseline to week 32 in the no rewards arm|||1|-11.1|<0.025
72436499|NCT02957539|144386408|SUPERIORITY||Mean Difference (Net)|0.6|||||TWO_SIDED|97.5|-0.5|1.8|||||Change in Self Efficacy score from baseline to week 16 in the financial rewards arm minus the change in Self Efficacy score from baseline to week 16 in the no rewards arm.|||1.8|-0.5|
72436500|NCT02957539|144386408|SUPERIORITY||Mean Difference (Net)|0.3|||||TWO_SIDED|97.5|-0.8|1.5|||||Change in Self Efficacy score from baseline to week 16 in the nonfinancial rewards arm minus the change in Self Efficacy score from baseline to week 16 in the no rewards arm.|||1.5|-0.8|
72436501|NCT02957539|144386409|SUPERIORITY||Mean Difference (Net)|0.1|||||TWO_SIDED|97.5|-1.2|1.4|||||The change in self efficacy from baseline to week 32 in the financial incentive arm minus the change in self efficacy from baseline to week 32 in the no rewards arm|||1.4|-1.2|
72436502|NCT02957539|144386409|SUPERIORITY||Mean Difference (Net)|0.5|||||TWO_SIDED|97.5|-0.9|1.8|||||The change in self efficacy from baseline to week 32 in the nonfinancial incentive arm minus the change in self efficacy from baseline to week 32 in the no rewards arm|||1.8|-.9|
72436503|NCT02957539|144386410|SUPERIORITY||Mean Difference (Net)|1.5|||||TWO_SIDED|97.5|0.2|2.8|||||The change in self efficacy from baseline to week 52 in the financial incentive arm minus the change in self efficacy from baseline to week 52 in the no rewards arm|||2.8|0.2|
72558342|NCT01438060|144646269|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.17||||0.802|TWO_SIDED|95.0|-1.15|1.49||Baseline data was evaluated by analysis of variance (ANOVA) with treatment and study center as main effects.|ANOVA||Model based estimate.|Analysis at Baseline (Day 0)||1.49|-1.15|0.802
72436504|NCT02957539|144386410|SUPERIORITY||Mean Difference (Net)|1.2|||||TWO_SIDED|97.5|0.0|2.3|||||The change in self efficacy from baseline to week 52 in the nonfinancial incentive arm minus the change in self efficacy from baseline to week 52 in the no rewards arm|||2.3|0.0|
72436505|NCT02957539|144386411|SUPERIORITY||Mean Difference (Net)|0.2|||||TWO_SIDED|97.5|-0.4|0.9|||||Change in intrinsic motivation score from baseline to week 16 in the financial rewards arm minus the change in intrinsic motivation score from baseline to week 16 in the no rewards arm.|||0.9|-0.4|
72436506|NCT02957539|144386411|SUPERIORITY||Mean Difference (Net)|0.0|||||TWO_SIDED|97.5|-0.6|0.7|||||Change in intrinsic motivation score from baseline to week 16 in the nonfinancial rewards arm minus the change in intrinsic motivation score from baseline to week 16 in the no rewards arm.|||0.7|-0.6|
72436507|NCT02957539|144386412|SUPERIORITY||Mean Difference (Net)|0.5|||||TWO_SIDED|97.5|-0.2|1.3|||||The change in intrinsic motivation from baseline to week 32 in the financial incentive arm minus the change in intrinsic motivation from baseline to week 32 in the no rewards arm|||1.3|-0.2|
72436508|NCT02957539|144386412|SUPERIORITY||Mean Difference (Net)|0.6|||||TWO_SIDED|97.5|-0.3|1.6|||||The change in intrinsic motivation from baseline to week 32 in the nonfinancial incentive arm minus the change in intrinsic motivation from baseline to week 32 in the no rewards arm|||1.6|-0.3|
72436509|NCT02957539|144386413|SUPERIORITY||Mean Difference (Final Values)|0.5|||||TWO_SIDED|97.5|-0.5|1.5|||||The change in intrinsic motivation from baseline to week 52 in the financial incentive arm minus the change in intrinsic motivation from baseline to week 52 in the no rewards arm|||1.5|-0.5|
72436510|NCT02957539|144386413|SUPERIORITY||Mean Difference (Net)|0.4|||||TWO_SIDED|97.5|-0.8|1.6|||||Incentive Group minus usual care|||1.6|-0.8|
72436511|NCT02957539|144386414|SUPERIORITY||Mean Difference (Net)|0.3|||||TWO_SIDED|97.5|-2.0|2.6|||||Change in PHQ-8 score from baseline to week 16 in the financial rewards arm minus the change in PHQ-8 score from baseline to week 16 in the no rewards arm.|||2.6|-2.0|
72436512|NCT02957539|144386414|SUPERIORITY||Mean Difference (Net)|0.7|||||TWO_SIDED|97.5|-1.5|2.9|||||Change in PHQ-9 from week baseline to week 16 in the non-financial incentive group minus the change from week baseline to week 16 in the no rewards group|||2.9|-1.5|
72436513|NCT02957539|144386415|SUPERIORITY||Mean Difference (Net)|1.4|||||TWO_SIDED|97.5|-1.7|4.5|||||The change in PHQ-8 from baseline to week 32 in the financial incentive arm minus the change in PHQ-8 from baseline to week 32 in the no rewards arm|||4.5|-1.7|
72436514|NCT02957539|144386415|SUPERIORITY||Mean Difference (Net)|2.2|||||TWO_SIDED|97.5|-0.7|5.0|||||The change in PHQ-8 from baseline to week 32 in the nonfinancial incentive arm minus the change in PHQ-8 from baseline to week 32 in the no rewards arm|||5.0|-0.7|
72436515|NCT02957539|144386416|SUPERIORITY||Mean Difference (Net)|-1.1|||||TWO_SIDED|97.5|-4.9|2.8|||||Change in PHQ-8 score from baseline to week 52 in the financial rewards arm minus the change in PHQ-8 score from baseline to week 52 in the no rewards arm.|||2.8|-4.9|
72436516|NCT02957539|144386416|SUPERIORITY||Mean Difference (Net)|0.3|||||TWO_SIDED|97.5|-2.9|3.6|||||The change in PHQ-8 from baseline to week 52 in the nonfinancial incentive arm minus the change in PHQ-8 from baseline to week 52 in the no rewards arm|||3.6|-2.9|
72494669|NCT00523991|144518819|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.35|||<|0.001||95.0|0.26|0.45||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms include treatment, site, and forced vital capacity at baseline~Mean Difference (Final Values) means difference in LSMeans"||tiotropium versus placebo||0.45|0.26|<0.001
72436517|NCT02957539|144386417|SUPERIORITY||Mean Difference (Net)|-3.2|||||TWO_SIDED|97.5|-7.4|1.0|||||Change in weight from baseline to week 16 in the financial rewards arm minus the change in weight from baseline to week 16 in the no rewards arm.|||1|-7.4|
72436518|NCT02957539|144386417|SUPERIORITY||Mean Difference (Net)|-4.6|||||TWO_SIDED|97.5|-8.7|-0.4|||||Change in weight from baseline to week 16 in the nonfinancial rewards arm minus the change in weight from baseline to week 32 in the no rewards arm.|||-0.4|-8.7|
72436519|NCT02957539|144386418|SUPERIORITY||Mean Difference (Net)|2.4|||||TWO_SIDED|97.5|-6.0|10.7|||||Change in weight from baseline to week 52 in the financial rewards arm minus the change in weight from baseline to week 52 in the no rewards arm.|||10.7|-6|
72436520|NCT02957539|144386418|SUPERIORITY||Mean Difference (Net)|-3.6|||||TWO_SIDED|97.5|-11.2|4.1|||||Change in weight from baseline to week 52 in the nonfinancial rewards arm minus the change in weight from baseline to week 52 in the no rewards arm.|||4.1|-11.2|
72436521|NCT01256034|144386420|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Chi-squared|||||||<0.05
72436522|NCT01596504|144386430|SUPERIORITY_OR_OTHER||Least squares (LS) mean difference|-6.01|STANDARD_ERROR_OF_MEAN|1.06|<|0.0001|ONE_SIDED|95.0|-7.77|||p-values ordered(p1≤p2) as per rules:if p2≤0.05: lixisenatide superior to liraglutide (both doses);if p2\>0.05 \& p1≤0.025:lixisenatide superior to dose of liraglutide associated with p1;if p2\>0.05 \& p1\>0.025:no comparison as statistically significant.|Linear fixed effects model|The threshold for significance at 0.05 level.|Lixisenatide vs Liraglutide 1.2 mg|Analysis was performed using linear fixed effects model with treatment groups and stratification factors (HbA1c levels on Day -7 \[\<8% and \>=8%\], use of metformin at screening \[yes or no\]) and the study site) as fixed effects and baseline plasma glucose AUC from 0.5 to 4.5 hours as covariate. To address multiplicity issue and ensure overall 1-sided level of 5%, Hochberg method was used for testing procedure of comparison between lixisenatide vs liraglutide 1.2 mg or 1.8 mg.|||-7.77|<0.0001
72436523|NCT01596504|144386430|SUPERIORITY_OR_OTHER||LS mean difference|-4.61|STANDARD_ERROR_OF_MEAN|1.04|<|0.0001|ONE_SIDED|95.0|-6.34|||p-values ordered(p1≤p2) as per rules:if p2≤0.05:lixisenatide superior to liraglutide (both doses);if p2\>0.05 \& p1≤0.025:lixisenatide superior to dose of liraglutide associated with p1;if p2\>0.05 \& p1\>0.025: no comparison as statistically significant.|Linear fixed effects model|The threshold for significance at 0.05 level.|Lixisenatide vs Liraglutide 1. 8 mg|Analysis was performed using linear mixed effects model with treatment groups and stratification factors (HbA1c levels on Day -7 \[\<8% and \>=8%\], use of metformin at screening \[yes or no\]), and the study site) as fixed effects and baseline plasma glucose AUC from 0.5 to 4.5 hours as covariate. To address multiplicity issue and ensure overall 1-sided level of 5%, Hochberg method was used for testing procedure of comparison between lixisenatide vs liraglutide 1.2 mg or 1.8 mg.|||-6.34|<0.0001
72436524|NCT01901276|144386447|SUPERIORITY_OR_OTHER_LEGACY|||||||0.71|||||||t-test, 2 sided|||Within-individual differences in Shannon indices were tested using paired t tests (normally distributed data).||||0.71
72558343|NCT01438060|144646269|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.02||||0.169|TWO_SIDED|95.0|-2.49|0.44||ANCOVA model for LOCF data set included the baseline measure as covariate and the study center and treatment as main effects.|ANCOVA||Model based estimate|Analysis at Week 10||0.44|-2.49|0.169
72436525|NCT04347954|144386448|OTHER||Mean Difference (Net)|-0.349|||||TWO_SIDED|95.0|-1.584|0.886||||||Analysis of change in mean Ct values incorporating baseline, hour 1, and day 3 values.||0.886|-1.584|
72558344|NCT01438060|144646272|SUPERIORITY_OR_OTHER||Response ratio|0.79||||0.391|TWO_SIDED|95.0|0.47|1.35|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test with controlling for treatment and study center||Analysis at Week 1||1.35|0.47|0.391
72384349|NCT01532973|144276359|SUPERIORITY_OR_OTHER||Difference in LS Means|3.95|||||TWO_SIDED|90.0|3.44|4.47||||||||4.47|3.44|
72384350|NCT01532973|144276360|SUPERIORITY_OR_OTHER||Difference in LS Means|3.89|||||TWO_SIDED|90.0|3.2|4.58||||||||4.58|3.20|
72384351|NCT01532973|144276360|SUPERIORITY_OR_OTHER||Difference in LS Means|4.67|||||TWO_SIDED|90.0|3.98|5.36||||||||5.36|3.98|
72384352|NCT01532973|144276360|SUPERIORITY_OR_OTHER||Difference in LS Means|3.61|||||TWO_SIDED|90.0|2.92|4.3||||||||4.30|2.92|
72384353|NCT01532973|144276361|SUPERIORITY_OR_OTHER||Difference in LS Means|0.72|||||TWO_SIDED|90.0|-0.09|1.54||||||||1.54|-0.09|
72384354|NCT01532973|144276361|SUPERIORITY_OR_OTHER||Difference in LS Means|2.57|||||TWO_SIDED|90.0|1.75|3.39||||||||3.39|1.75|
72384355|NCT01532973|144276361|SUPERIORITY_OR_OTHER||Difference in LS Means|2.84|||||TWO_SIDED|90.0|2.02|3.66||||||||3.66|2.02|
72384356|NCT01532973|144276362|SUPERIORITY_OR_OTHER||Difference in LS Means|3.17|||||TWO_SIDED|90.0|2.55|3.8||||||||3.80|2.55|
72384357|NCT01532973|144276362|SUPERIORITY_OR_OTHER||Difference in LS Means|3.63|||||TWO_SIDED|90.0|3.0|4.26||||||||4.26|3.00|
72384358|NCT03950791|144276401|SUPERIORITY||Mann-Whitney U|3864.0|STANDARD_ERROR_OF_MEAN|302.0||0.89|TWO_SIDED|||||Not adjusted for multiple comparisons, p \< .05 used as threshold for statistical significance|Independent-samples Mann-Whitney U|No adjustments for multiple comparisons|Standardized Test Statistic = .139|Morphine equivalent dosage outcome variables were not normally distributed (skewness values between 4.5 and 4.8, kurtosis values between 25.7 and 30.0), which necessitated non-parametric analysis using independent-samples Mann-Whitney U Test||||.89
72384359|NCT02719327|144276402|SUPERIORITY||Slope|-2.18||||0.17|TWO_SIDED|95.0|-5.36|0.99||ASL values at 18 months were regressed on treatment group (IPE vs placebo) statistically controlling for age at baseline visit and ASL measured at baseline visit.|Regression, Linear|||The proposed study aims to investigate the effects of 18 months of IPE vs. placebo on regional cerebral blood flow in the bilateral posterior cingulate gyrus as measured by arterial spin-labeling MRI . IPE was hypothesized to improve regional cerebral blood flow over placebo after 18 months.||0.99|-5.36|0.17
72384360|NCT02719327|144276403|SUPERIORITY||Slope|0.11||||0.12|TWO_SIDED|95.0|-0.04|0.25|||Regression, Linear|18 month Beta-amyloid(1-42) was regressed on group (IPE vs placebo) and covariates age at baseline visit and Beta-amyloid(1-42) at baseline visit.|Placebo group is the reference group.|Beta-amyloid(1-42) concentration in CSF was log-transformed prior to analysis to approximate a normal distribution.||0.25|-0.04|.12
72384361|NCT02719327|144276403|SUPERIORITY||Slope|0.045||||0.05|TWO_SIDED|95.0|0.004|0.061|||Regression, Linear|log-transformed 18 month pTau181 was regressed on group (IPE vs placebo) and covariates age at baseline and log-transformed ptau181at baseline visit.|Placebo group is the reference group.|Phosphorylated tau (pTau181) measured in CSF was log-transformed prior to analysis to approximate a normal distribution.||0.061|0.004|0.05
72384362|NCT02719327|144276403|SUPERIORITY||Slope|0.046||||0.07|TWO_SIDED|95.0|-0.0008|0.106||18 months total Tau was regressed on Group (IPE vs placebo) and covariates age at baseline and total Tau at baseline.|Regression, Linear||Placebo group was the reference group.|Total tau was log-transformed prior to analysis to better approximate a normal distribution.||0.106|-0.0008|.07
72384363|NCT02719327|144276404|SUPERIORITY||Slope|0.006||||0.48|TWO_SIDED|95.0|-0.009|0.023|||Linear Mixed Effects model|Covariates included education level, gender, and age at baseline visit.|Placebo group was the reference group.|Four cognitive tests were standardized (baseline mean and standard deviation) prior to averaging to create the ADCS Preclinical Alzheimer Cognitive Composite (ADCS-PACC) score. The final composite score was standardized again using baseline mean and standard deviation (range -3.15 to 3.10). Higher scores indicate better cognitive performance. A linear mixed effects model was used to determine if change in ADCS-PACC composite scores was modified by treatment group.||0.023|-0.009|.48
72384364|NCT01470859|144276407|SUPERIORITY_OR_OTHER|||||||0.84|TWO_SIDED|||||"p\<0.05 is indicating the threshold for statistical significance for this comparison"|t-test, 2 sided|independent sample t-test The statistical analysis was performed on the changes of PDRP Z score between levodopa and pramipexole groups.||||||0.84
72384365|NCT01470859|144276407|SUPERIORITY_OR_OTHER|||||||0.93|TWO_SIDED|||||"p\<0.05 is indicating the threshold for statistical significance for this comparison"|t-test, 2 sided|independent sample t-test The statistical analysis was performed to compare the PDRP Z scores between levodopa and pramipexole groups at V1||||||0.93
72384366|NCT01470859|144276407|SUPERIORITY_OR_OTHER|||||||0.31|TWO_SIDED|||||"p\<0.05 is indicating the threshold for statistical significance for this comparison"|t-test, 2 sided|independent sample t-test The statistical analysis was performed to compare the PDRP Z scores between levodopa and pramipexole groups at V5||||||0.31
72384367|NCT01470859|144276408|SUPERIORITY_OR_OTHER|||||||0.691|TWO_SIDED|||||"p\<0.05 is indicating the threshold for statistical significance for this comparison"|independent U test|independent U test The statistical analysis was performed to compare the UPDRS II scores at V1 scores between the levodopa and pramipexole groups||||||0.691
72384368|NCT01470859|144276408|SUPERIORITY_OR_OTHER|||||||0.706|TWO_SIDED|||||"p\<0.05 is indicating the threshold for statistical significance for this comparison"|independent U test|independent U test The statistical analysis was performed to compare the UPDRS II scores at V2 scores between the levodopa and pramipexole groups||||||0.706
72384369|NCT01470859|144276408|SUPERIORITY_OR_OTHER|||||||0.635|TWO_SIDED|||||"p\<0.05 is indicating the threshold for statistical significance for this comparison"|independent U test|independent U test The statistical analysis was performed to compare the UPDRS II scores at V5 scores between the levodopa and pramipexole groups||||||0.635
72384370|NCT01470859|144276408|SUPERIORITY_OR_OTHER|||||||0.341|TWO_SIDED|||||"p\<0.05 is indicating the threshold for statistical significance for this comparison"|independent U test|independent U test The statistical analysis was performed to compare the UPDRS III scores at V1 scores between the levodopa and pramipexole groups||||||0.341
72436526|NCT04347954|144386448|OTHER||Mean Difference (Net)|-1.059|||||TWO_SIDED|95.0|-2.318|0.201||||||Analysis of change in mean Ct values incorporating baseline, hour 1, and day 3 values.||0.201|-2.318|
72436527|NCT00761930|144386459|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||<0.05
72436528|NCT00761930|144386460|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||<0.05
72436529|NCT00761930|144386461|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||<0.05
72436530|NCT03257813|144386462|NON_INFERIORITY|it will be considered not inferior if they keep the IOP goal with differences of no more than 1.5 mmHg||||||0.013||||||Baseline|t-test, 2 sided|||||||0.013
72436531|NCT03257813|144386462|NON_INFERIORITY|it will be considered not inferior if they keep the IOP goal with differences of no more than 1.5 mmHg||||||0.001||||||CrossOver|t-test, 2 sided|||||||0.001
72436532|NCT03257813|144386462|NON_INFERIORITY|it will be considered not inferior if they keep the IOP goal with differences of no more than 1.5 mmHg||||||0.05||||||Final Visit|t-test, 2 sided|||||||0.050
72436533|NCT03257813|144386463|NON_INFERIORITY|to be considered as not inferior to the group, the differences between both should not be greater than 2 points on the snellen scale||||||0.823||||||Baseline|t-test, 2 sided|||||||0.823
72436534|NCT03257813|144386463|NON_INFERIORITY|to be considered as not inferior to the group, the differences between both should not be greater than 2 points on the snellen scale||||||0.507||||||CrossOver|t-test, 2 sided|||||||0.507
72436535|NCT03257813|144386463|NON_INFERIORITY|to be considered as not inferior to the group, the differences between both should not be greater than 2 points on the snellen scale||||||0.495||||||Final Visit|t-test, 2 sided|||||||0.495
72436536|NCT03257813|144386464|NON_INFERIORITY|to be considered as not inferior to the group, the differences between both should not be greater than 20% of the frequency.||||||0.085|||||||Chi-squared|||||||0.085
72436537|NCT03257813|144386465|NON_INFERIORITY|to be considered as not inferior to the group, the differences between both should not be greater than 20% of the frequency.||||||0.001||||||Baseline|Fisher Exact|||||||0.001
72436538|NCT03257813|144386465|NON_INFERIORITY|to be considered as not inferior to the group, the differences between both should not be greater than 20% of the frequency.||||||0.148||||||CrossOver|Fisher Exact|||||||0.148
72436539|NCT03257813|144386465|NON_INFERIORITY|to be considered as not inferior to the group, the differences between both should not be greater than 20% of the frequency.||||||0.212||||||Final Visit|Fisher Exact|||||||0.212
72436540|NCT03257813|144386466|NON_INFERIORITY|to be considered as not inferior to the group, the differences between both should not be greater than 20% of the frequency.||||||0.497||||||Baseline|Chi-squared, Corrected|||||||0.497
72436541|NCT03257813|144386466|NON_INFERIORITY|to be considered as not inferior to the group, the differences between both should not be greater than 20% of the frequency.||||||0.497||||||CrossOver|Chi-squared, Corrected|||||||0.497
72436542|NCT03257813|144386466|NON_INFERIORITY|to be considered as not inferior to the group, the differences between both should not be greater than 20% of the frequency.||||||0||||||"Final Visit~No statistic will be calculated because Final Chemosis is a constant"|Chi-squared, Corrected|||||||0
72436543|NCT03257813|144386467|NON_INFERIORITY|to be considered as not inferior to the group, the differences between both should not be greater than 20% of the frequency.||||||1||||||baseline|Chi-squared|||||||1.000
72436544|NCT03257813|144386467|NON_INFERIORITY|to be considered as not inferior to the group, the differences between both should not be greater than 20% of the frequency.||||||0.391||||||Cross Over|Chi-squared|||||||0.391
72436545|NCT03257813|144386467|NON_INFERIORITY|to be considered as not inferior to the group, the differences between both should not be greater than 20% of the frequency.||||||0.534||||||Final Visit|Chi-squared|||||||0.534
72436546|NCT03257813|144386468|NON_INFERIORITY|to be considered as not inferior to the group, the differences between both should not be greater than 20% of the frequency.||||||0.023||||||Baseline|Chi-squared, Corrected|||||||0.023
72436547|NCT03257813|144386468|NON_INFERIORITY|to be considered as not inferior to the group, the differences between both should not be greater than 20% of the frequency.||||||1||||||CrossOver|Chi-squared|||||||1.000
72436548|NCT03257813|144386468|NON_INFERIORITY|to be considered as not inferior to the group, the differences between both should not be greater than 20% of the frequency.||||||0.793||||||Final Visit|Chi-squared|||||||0.793
72436549|NCT03257813|144386469|NON_INFERIORITY|to be considered as not inferior to the group, the differences between both should not be greater than 20% of the frequency.||||||0.825||||||Baseline|Chi-squared|||||||0.825
72436550|NCT03257813|144386469|NON_INFERIORITY|to be considered as not inferior to the group, the differences between both should not be greater than 20% of the frequency.||||||1||||||CrossOver|Chi-squared|||||||1.000
72436551|NCT03257813|144386469|NON_INFERIORITY|to be considered as not inferior to the group, the differences between both should not be greater than 20% of the frequency.||||||0.765|||||||Chi-squared|||||||0.765
72436552|NCT02878330|144386470|SUPERIORITY||Relative Risk Reduction|70.1|||<|0.0001|TWO_SIDED|95.0|52.3|81.2|||Poisson regression|||||81.2|52.3|<0.0001
72436553|NCT02878330|144386471|SUPERIORITY||Relative Risk Reduction|78.4||||0.0002|TWO_SIDED|95.0|51.9|90.3|||Poisson regression|||||90.3|51.9|0.0002
72436554|NCT02459899|144386483|SUPERIORITY||Least squares mean difference|-0.25|STANDARD_ERROR_OF_MEAN|0.139||0.07|TWO_SIDED|95.0|-0.53|0.02||Threshold for significance \< 0.05|MMRM|||Analysis was performed using MMRM model with treatment, randomization strata of insulin delivery method (CSII, MDI), time (study week), and a treatment-by-time interaction as fixed categorical effects, and Baseline A1C-by-time interaction as a covariate.||0.02|-0.53|0.07
72436555|NCT02459899|144386483|SUPERIORITY||Least squares mean difference|-0.48|STANDARD_ERROR_OF_MEAN|0.135|<|0.001|TWO_SIDED|95.0|-0.75|-0.22||Threshold for significance \< 0.05|MMRM|||Analysis was performed using MMRM model with treatment, randomization strata of insulin delivery method (CSII, MDI), time (study week), and a treatment-by-time interaction as fixed categorical effects, and Baseline A1C-by-time interaction as a covariate.||-0.22|-0.75|<0.001
72436556|NCT02459899|144386483|SUPERIORITY||Least squares mean difference|-0.38|STANDARD_ERROR_OF_MEAN|0.136||0.006|TWO_SIDED|95.0|-0.65|-0.11||Threshold for significance \< 0.05|MMRM|||Analysis was performed using MMRM model with treatment, randomization strata of insulin delivery method (CSII, MDI), time (study week), and a treatment-by-time interaction as fixed categorical effects, and Baseline A1C-by-time interaction as a covariate.||-0.11|-0.65|0.006
72494670|NCT00523991|144518826|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.02||||0.927||95.0|-0.38|0.41||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms include treatment, site, and albuterol use at baseline~Mean Difference (Final Values) means difference in LSMeans"||tiotropium versus placebo||0.41|-0.38|0.927
72494671|NCT00523991|144518827|SUPERIORITY_OR_OTHER|||||||0.174||95.0|||||Cochran-Mantel-Haenszel|Site as stratum||tiotropium versus placebo||||0.174
72494672|NCT00523991|144518828|SUPERIORITY_OR_OTHER|||||||0.186||95.0|||||Cochran-Mantel-Haenszel|Site as stratum||tiotropium versus placebo||||0.186
72494673|NCT00523991|144518829|SUPERIORITY_OR_OTHER|||||||0.045||95.0|||||Cochran-Mantel-Haenszel|Site as stratum||tiotropium versus placebo||||0.045
72494674|NCT00523991|144518830|SUPERIORITY_OR_OTHER|||||||0.223||95.0|||||Cochran-Mantel-Haenszel|Site as stratum||tiotropium versus placebo||||0.223
72494675|NCT00523991|144518831|SUPERIORITY_OR_OTHER|||||||0.01||95.0|||||Cochran-Mantel-Haenszel|Site as stratum||tiotropium versus placebo||||0.010
72384371|NCT01470859|144276408|SUPERIORITY_OR_OTHER|||||||0.049|TWO_SIDED|||||"p\<0.05 is indicating the threshold for statistical significance for this comparison"|independent U test|independent U test The statistical analysis was performed to compare the UPDRS III scores at V2 scores between the levodopa and pramipexole groups||||||0.049
72384372|NCT01470859|144276408|SUPERIORITY_OR_OTHER|||||||0.874|TWO_SIDED|||||"p\<0.05 is indicating the threshold for statistical significance for this comparison"|independent U test|independent U test The statistical analysis was performed to compare the UPDRS III scores at V5 scores between the levodopa and pramipexole groups||||||0.874
72384373|NCT01470859|144276409|SUPERIORITY_OR_OTHER|||||||0.72|TWO_SIDED|||||"p\<0.05 is indicating the threshold for statistical significance for this comparison"|independent U test|independent U test The statistical analysis was performed to compare the PDQ39 scores between levodopa and pramipexole group at V1||||||0.720
72384374|NCT01470859|144276409|SUPERIORITY_OR_OTHER|||||||0.867|TWO_SIDED|||||"p\<0.05 is indicating the threshold for statistical significance for this comparison"|independent U test|independent U test The statistical analysis was performed to compare the PDQ39 scores between levodopa and pramipexole group at V5||||||0.867
72384375|NCT01470859|144276410|SUPERIORITY_OR_OTHER|||||||0.793|TWO_SIDED|||||"p\<0.05 is indicating the threshold for statistical significance for this comparison"|indenpendent U test|independent U test The statistical analysis was performed to compare the H\&Y stages between levodopa and pramipexole group at V1||||||0.793
72384376|NCT01470859|144276410|SUPERIORITY_OR_OTHER|||||||0.43|TWO_SIDED|||||"p\<0.05 is indicating the threshold for statistical significance for this comparison"|independent U test|independent U test The statistical analysis was performed to compare the H\&Y stages between levodopa and pramipexole groups at V5||||||0.430
72384377|NCT01470859|144276411|SUPERIORITY_OR_OTHER|||||||0.345|TWO_SIDED|||||"p\<0.05 is indicating the threshold for statistical significance for this comparison"|Chi-squared|The statistical analysis was performed to compare the clinical improvement between levodopa and pramipexole groups at V2||||||0.345
72384378|NCT01470859|144276411|SUPERIORITY_OR_OTHER|||||||0.41|TWO_SIDED|||||"p\<0.05 is indicating the threshold for statistical significance for this comparison"|Chi-squared|The statistical analysis was performed to compare the clinical improvement between levodopa and pramipexole groups at V5||||||0.410
72384379|NCT05268055|144276420|SUPERIORITY|||||||0.525|||||||t-test, 2 sided|||Group comparison of all participants.||||0.525
72384380|NCT05268055|144276420|SUPERIORITY|||||||0.045|||||||t-test, 2 sided|||Group comparison of participants less than age 33.||||0.045
72384381|NCT05268055|144276420|SUPERIORITY|||||||0.046|||||||t-test, 2 sided|||Group comparison of participants age 33 and greater.||||0.046
72384382|NCT05268055|144276421|SUPERIORITY|||||||0.2|||||||t-test, 2 sided|||Group comparison of all participants.||||0.200
72384383|NCT05268055|144276421|SUPERIORITY|||||||0.075|||||||t-test, 2 sided|||Group comparison of participants less than age 33.||||0.075
72384384|NCT05268055|144276421|SUPERIORITY|||||||0.015|||||||t-test, 2 sided|||Group comparison of participants age 33 and greater.||||0.015
72384385|NCT05268055|144276422|SUPERIORITY|||||||0.246|||||||t-test, 2 sided|||Group comparison of all participants.||||0.246
72494676|NCT00523991|144518832|SUPERIORITY_OR_OTHER|||||||0.086||95.0|||||Cochran-Mantel-Haenszel|Site as stratum||tiotropium versus placebo||||0.086
72494677|NCT00523991|144518834|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.64||||0.729||95.0|-2.97|4.24||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms for treatment, site, and work productivity at baseline~Mean Difference (Final Values) means difference in LS Means"||tiotropium versus placebo||4.24|-2.97|0.729
72494678|NCT00523991|144518835|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.5||||0.149||95.0|-5.9|0.9||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms for treatment, site, and work productivity at baseline~Mean Difference (Final Values) means difference in LS Means"||tiotropium versus placebo||0.90|-5.90|0.149
72494679|NCT00523991|144518836|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.53||||0.763||95.0|-4.0|2.93||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms for treatment, site, and work productivity at baseline~Mean Difference (Final Values) means difference in LSMeans"||tiotropium versus placebo||2.93|-4.00|0.763
72494680|NCT00523991|144518837|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.85||||0.313||95.0|-5.45|1.75||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms for treatment, site, and work productivity at baseline~Mean Difference (Final Values) means difference in LS Means"||tiotropium versus placebo||1.75|-5.45|0.313
72494681|NCT00523991|144518838|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.79||||0.682||95.0|-4.6|3.01||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms for treatment, site, and work productivity at baseline~Mean Difference (Final Values) means difference in LS Means"||tiotropium versus placebo||3.01|-4.60|0.682
72558345|NCT01438060|144646272|SUPERIORITY_OR_OTHER||Response ratio|0.95||||0.766|TWO_SIDED|95.0|0.69|1.31|||Cochran-Mantel-Haenszel|CMH test with controlling for treatment and study center||Analysis at Week 2||1.31|0.69|0.766
72384386|NCT05268055|144276422|SUPERIORITY|||||||0.151|||||||t-test, 2 sided|||Group comparison of participants less than age 33.||||0.151
72494682|NCT00523991|144518839|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.76||||0.043||95.0|-7.39|-0.13||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms for treatment, site, and work productivity at baseline~Mean Difference (Final Values) means difference in LS Means"||tiotropium versus placebo||-0.13|-7.39|0.043
72494683|NCT00523991|144518841|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.61||||0.823||95.0|-6.01|4.79||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms for treatment, site, and work productivity at baseline~Mean Difference (Final Values) means difference in LSMeans"||tiotropium versus placebo||4.79|-6.01|0.823
72494684|NCT00523991|144518842|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.03||||0.767||95.0|-7.86|5.81||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms for treatment, site, and work productivity at baseline~Mean Difference (Final Values) means difference in LSMeans"||tiotropium versus placebo||5.81|-7.86|0.767
72494685|NCT00523991|144518843|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.77||||0.754||95.0|-4.12|5.67||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms for treatment, site, and work productivity at baseline~Mean Difference (Final Values) means difference in LSMeans"||tiotropium versus placebo||5.67|-4.12|0.754
72494686|NCT00523991|144518844|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02||||0.995||95.0|-6.31|6.27||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms for treatment, site, and work productivity at baseline~Mean Difference (Final Values) means difference in LSMeans"||tiotropium versus placebo||6.27|-6.31|0.995
72494687|NCT00523991|144518845|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.19||||0.72||95.0|-7.77|5.39||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms for treatment, site, and work productivity at baseline~Mean Difference (Final Values) means difference in LSMeans"||tiotropium versus placebo||5.39|-7.77|0.720
72494688|NCT00523991|144518846|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.88||||0.064||95.0|-12.1|0.35||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms for treatment, site, and work productivity at baseline~Mean Difference (Final Values) means difference in LS Means"||tiotropium versus placebo||0.35|-12.10|0.064
72384387|NCT05268055|144276422|SUPERIORITY|||||||0.033|||||||t-test, 2 sided|||Group comparison of participants age 33 and greater.||||0.033
72384388|NCT05268055|144276423|SUPERIORITY|||||||0.212|||||||t-test, 2 sided|||Group comparison of all participants.||||0.212
72384389|NCT05268055|144276423|SUPERIORITY|||||||0.893|||||||t-test, 2 sided|||Group comparison of participants less than age 33.||||0.893
72384390|NCT05268055|144276423|SUPERIORITY|||||||0.16|||||||t-test, 2 sided|||Group comparison of participants age 33 and greater.||||0.160
72384391|NCT05268055|144276424|SUPERIORITY|||||||0.752|||||||t-test, 2 sided|||Group comparison of self-rating scores on the Healthcare Provider Cultural Competence measure.||||0.752
72384392|NCT05268055|144276424|SUPERIORITY|||||||0.493|||||||t-test, 2 sided|||Group comparison of self-rating scores on the Ask, Understand, Remember Assessment.||||0.493
72384393|NCT05268055|144276424|SUPERIORITY|||||||0.085|||||||t-test, 2 sided|||Group comparison of self-rating scores on the Wake Forest Physician Trust Scale.||||0.085
72384394|NCT02203071|144276425|SUPERIORITY|||||||0.61|||||||Fisher Exact|||||||0.61
72384395|NCT02203071|144276426|SUPERIORITY|||||||0.001|||||||t-test, 2 sided|||||||.001
72384396|NCT02203071|144276427|SUPERIORITY||||||>|0.11|||||||t-test, 2 sided|||||||>0.11
72384397|NCT02203071|144276428|SUPERIORITY||||||<|0.007|||||||ANOVA|||||||<0.007
72384398|NCT02203071|144276429|SUPERIORITY||||||<|0.001|||||||ANOVA|||||||<0.001
72384399|NCT02203071|144276430|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1
72384400|NCT03793556|144276431|OTHER||Mean Difference (Final Values)|-2.5|STANDARD_DEVIATION|9.27||0.276|TWO_SIDED|95.0|-7.03|2.04|||Unpaired t test|||||2.04|-7.03|0.276
72384401|NCT03793556|144276432|OTHER|||||||0.0157|||||||ANOVA|The ANOVA model examined the entire curve profile.||||||0.0157
72384402|NCT03793556|144276442|OTHER|||||||0.0496|||||||Chi-squared|||||||0.0496
72384403|NCT03793556|144276444|OTHER|||||||0.0065|||||||ANOVA|||||||0.0065
72494689|NCT00523991|144518848|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.11||||0.718||95.0|-7.21|4.98||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms for treatment, site, and work productivity at baseline~Mean Difference (Final Values) means difference in LSMeans"||tiotropium versus placebo||4.98|-7.21|0.718
72494690|NCT00523991|144518849|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.42||||0.912||95.0|-7.9|7.06||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms for treatment, site, and work productivity at baseline~Mean Difference (Final Values) means difference in LSMeans"||tiotropium versus placebo||7.06|-7.90|0.912
72494691|NCT00523991|144518850|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.79||||0.162||95.0|-1.55|9.13||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms for treatment, site, and work productivity at baseline~Mean Difference (Final Values) means difference in LSMeans"||tiotropium versus placebo||9.13|-1.55|0.162
72558346|NCT01438060|144646272|SUPERIORITY_OR_OTHER||Response ratio|1.01||||0.967|TWO_SIDED|95.0|0.76|1.32||CMH test with controlling for treatment and study center|Cochran-Mantel-Haenszel|||Analysis at Week 3||1.32|0.76|0.967
72436557|NCT04470193|144386494|SUPERIORITY|We approached 62 subjects to get a sample size of 50 participants, allowing up to 16% attrition, to estimate the proportions of patients satisfying dropout of 0.13 to within margins of error (half-widths of 90% Cis). The 50 evaluable subjects were used to estimate the SD of QoL, with a margin of error of ∼20%. The sample size also allowed us to provide provisional estimates of the effect size for the QoL outcome to within a margin of error of ±7.1 points, assuming a true SD of 15 points.|||||>|0.05|||||||generalized estimating equation model|||We used a generalized estimating equation model for repeated assessments, with a common unstructured residual covariance matrix to account for correlation in repeated measurements in the same patient, to compare QoL total score at baseline, 1 month, and 3 months between the groups. We hypothesized that MyChildCMC users would have better outcomes for the child (higher QoL, fewer ED and/or hospital use and hospital days) and parent (higher satisfaction with child's care).||||>0.05
72436558|NCT04470193|144386495|SUPERIORITY||Risk Ratio (RR)|1.05||||0.882|TWO_SIDED|95.0|0.58|1.88|||Mixed Models Analysis|||||1.88|0.58|0.882
72436559|NCT04470193|144386496|SUPERIORITY||Risk Ratio (RR)|0.49|||<|0.001|TWO_SIDED|95.0|0.39|0.62|||Mixed Models Analysis|||||0.62|0.39|<0.001
72436560|NCT04470193|144386497|SUPERIORITY||Risk Ratio (RR)|1.11||||0.035|TWO_SIDED|95.0|1.01|1.22|||Mixed Models Analysis|||||1.22|1.01|0.035
72436561|NCT00361283|144386534|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-111.0|STANDARD_ERROR_OF_MEAN|76.7||0.15|TWO_SIDED|95.0|-264.0|42.0||No confounders were controlled for as each person is his/her own control.|t-test, 2 sided|||The study in healthy volunteers was to compare levels at baseline to 16 weeks in ENA-78, a cytokine. The one sample t-test was used to obtain the result.||42|-264|0.15
72384404|NCT04612790|144276452|OTHER||Difference in percentage of responders|6.7||||0.509|TWO_SIDED|95.0|-10.9|24.29|||Logistic regression model with Firth adj|||Estimates were from a logistic regression model using the Firth adjustment (adj) that included treatment group, baseline disease severity (moderate, severe) and time of BP diagnosis (participants with newly diagnosed BP, participants with a previous diagnosis of BP who have relapsed) as categorical covariates.||24.29|-10.90|0.509
72384405|NCT00408629|144276464|SUPERIORITY_OR_OTHER|||||||0.019||||||Testing for ranked co-primary endpoints occurred in hierarchical order to control for multiple testing. Week 8 remission rate was tested first. If a significant difference in group rates was found at alpha=0.05, Week 52 rate was tested at alpha=0.05.|Cochran-Mantel-Haenszel|Stratification levels for Cochran-Mantel-Haenszel = prior anti-TNF versus anti-TNF-naive.||Assuming that 5% of the subjects in the placebo group achieve clinical remission at Week 52 or Week 8, a sample size of 250 in each treatment group will be adequate to detect a difference of at least 7 percentage points from the adalimumab group using Chi squared test with 80% power at a 0.05 two-sided significance level.||||0.019
72384406|NCT00408629|144276465|SUPERIORITY_OR_OTHER|||||||0.004||||||Testing for ranked co-primary endpoints occurred in hierarchical order to control for multiple testing. Week 8 remission rate was tested first. If a significant difference in group rates was found at alpha=0.05, Week 52 rate was tested at alpha=0.05.|Cochran-Mantel-Haenszel|Stratification levels for Cochran-Mantel-Haenszel = prior anti-TNF versus anti-TNF-naive.||Assuming that 5% of the subjects in the placebo group achieve clinical remission at Week 52 or Week 8, a sample size of 250 in each treatment group will be adequate to detect a difference of at least 7 percentage points from the adalimumab group using Chi squared test with 80% power at a 0.05 two-sided significance level.||||0.004
72384407|NCT00408629|144276466|SUPERIORITY_OR_OTHER|||||||0.047||||||Testing of ranked secondary measures was only started if significant group differences existed for both co-primary measures. Significant results for higher-ranked measure was needed to test next lower-ranked measure to control for multiple testing.|Cochran-Mantel-Haenszel|Stratification levels for Cochran-Mantel-Haenszel = prior anti-TNF versus anti-TNF-naive.||The Cochran-Mantel-Haenszel test was used to test the null hypothesis of no difference between adalimumab and placebo. Treatment differences were deemed statistically significant at a significance level of 0.05.||||0.047
72384408|NCT00408629|144276467|SUPERIORITY_OR_OTHER||||||<|0.001||||||Testing of ranked secondary measures was only started if significant group differences existed for both co-primary measures. Significant results for higher-ranked measure was needed to test next lower-ranked measure to control for multiple testing.|Cochran-Mantel-Haenszel|Stratification levels for Cochran-Mantel-Haenszel = prior anti-TNF versus anti-TNF-naive.||The Cochran-Mantel-Haenszel test was used to test the null hypothesis of no difference between adalimumab and placebo. Treatment differences were deemed statistically significant at a significance level of 0.05.||||<0.001
72384409|NCT00408629|144276468|SUPERIORITY_OR_OTHER|||||||0.002||||||Testing of ranked secondary measures was only started if significant group differences existed for both co-primary measures. Significant results for higher-ranked measure was needed to test next lower-ranked measure to control for multiple testing.|Cochran-Mantel-Haenszel|Stratification levels for Cochran-Mantel-Haenszel = prior anti-TNF versus anti-TNF-naive.||The Cochran-Mantel-Haenszel test was used to test the null hypothesis of no difference between adalimumab and placebo. Treatment differences were deemed statistically significant at a significance level of 0.05.||||0.002
72384410|NCT00408629|144276469|SUPERIORITY_OR_OTHER||||||<|0.001||||||Testing of ranked secondary measures was only started if significant group differences existed for both co-primary measures. Significant results for higher-ranked measure was needed to test next lower-ranked measure to control for multiple testing.|Cochran-Mantel-Haenszel|Stratification levels for Cochran-Mantel-Haenszel = prior anti-TNF versus anti-TNF-naive.||The Cochran-Mantel-Haenszel test was used to test the null hypothesis of no difference between adalimumab and placebo. Treatment differences were deemed statistically significant at a significance level of 0.05.||||<0.001
72436562|NCT00038103|144386535|SUPERIORITY_OR_OTHER||Clinical Benefit Rate|49.0||||||95.0|34.4|63.7|||||Number of subjects showing clinical benefits out of the number of subjects in the evaluable set.|||63.7|34.4|
72436563|NCT00038103|144386535|SUPERIORITY_OR_OTHER||Clinical Benefit Rate|47.1||||||95.0|32.9|61.5|||||Number of subjects showing clinical benefits out of the number of subjects in the evaluable set.|||61.5|32.9|
72436564|NCT00038103|144386536|SUPERIORITY_OR_OTHER||Objective Response Rate|22.4||||||95.0|11.8|36.6|||||Number of subjects showing objective response out of the number of subjects in the evaluable set.|||36.6|11.8|
72436565|NCT00038103|144386536|SUPERIORITY_OR_OTHER||Objective Response Rate|23.5||||||95.0|12.8|37.5|||||Number of subjects showing objective response out of the number of subjects in the evaluable set.|||37.5|12.8|
72436566|NCT05147233|144386548|SUPERIORITY||Difference in Percentages|33.2|||<|0.0001|TWO_SIDED|95.0|21.5|44.9|||Wald test|||||44.9|21.5|<0.0001
72558347|NCT01438060|144646272|SUPERIORITY_OR_OTHER||Response ratio|0.92||||0.505|TWO_SIDED|95.0|0.71|1.19||CMH test with controlling for treatment and study center|Cochran-Mantel-Haenszel|||Analysis at Week 4||1.19|0.71|0.505
72494692|NCT00523991|144518851|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.59||||0.471||95.0|-4.51|9.69||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms for treatment, site, and work productivity at baseline~Mean Difference (Final Values) means difference in LSMeans"||tiotropium versus placebo||9.69|-4.51|0.471
72436567|NCT05147233|144386549|SUPERIORITY||Difference in Percentages|23.5|||<|0.0001|TWO_SIDED|95.0|11.7|35.3|||Wald test|||||35.3|11.7|<0.0001
72436568|NCT04517864|144386551|SUPERIORITY||Least Squares Mean Difference|0.021|STANDARD_ERROR_OF_MEAN|0.0382|||TWO_SIDED|95.0|-0.056|0.097||There was no formal statistical hypothesis testing for this study, and hence there was no P-value.|Mixed Models Analysis|Linear Mixed-effects Model: baseline, treatment group, visit and treatment group by visit interaction as fixed effects; participant as a random effect||||0.097|-0.056|
72436569|NCT04517864|144386552|SUPERIORITY||Least Squares Mean Difference|0.009|STANDARD_ERROR_OF_MEAN|0.0307|||TWO_SIDED|95.0|-0.052|0.07||There was no formal statistical hypothesis testing for this study, and hence there was no P-value.|Mixed Models Analysis|Linear mixed-effects model: baseline, treatment group, visit and treatment group by visit interaction as fixed effects; participant as a random effect||||0.070|-0.052|
72436570|NCT04517864|144386553|SUPERIORITY||Least Squares Mean Difference|-0.006|STANDARD_ERROR_OF_MEAN|0.0297|||TWO_SIDED|95.0|-0.065|0.053||There was no formal statistical hypothesis testing for this study, and hence there was no P-value.|Mixed Models Analysis|Linear Mixed-effects Model: baseline, treatment group, visit and treatment group by visit interaction as fixed effects; participant as a random effect||||0.053|-0.065|
72436571|NCT04517864|144386555|SUPERIORITY||Least Squares Mean Difference|0.042|STANDARD_ERROR_OF_MEAN|0.0235|||TWO_SIDED|95.0|-0.005|0.088||There was no formal statistical hypothesis testing for this study, and hence there was no P-value.|Mixed Models Analysis|Linear mixed-effects model: baseline, treatment group, visit and treatment group by visit interaction as fixed effects; participant as a random effect||||0.088|-0.005|
72436572|NCT04517864|144386561|SUPERIORITY||Least Squares Mean Difference|-0.015|STANDARD_ERROR_OF_MEAN|0.0224|||TWO_SIDED|95.0|-0.059|0.03||There was no formal statistical hypothesis testing for this study, and hence there was no P-value.|Mixed Models Analysis|Linear mixed-effects model: baseline, treatment group, visit and treatment group by visit interaction as fixed effects; participant as a random effect||Month 6||0.030|-0.059|
72436573|NCT04517864|144386561|SUPERIORITY||Least Squares Mean Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.0236|||TWO_SIDED|95.0|-0.107|-0.012||There was no formal statistical hypothesis testing for this study, and hence there was no P-value.|Mixed Models Analysis|Linear mixed-effects model: baseline, treatment group, visit and treatment group by visit interaction as fixed effects; participant as a random effect||Month 9||-0.012|-0.107|
72558348|NCT01438060|144646272|SUPERIORITY_OR_OTHER||Response ratio|1.07||||0.59|TWO_SIDED|95.0|0.84|1.36||CMH test with controlling for treatment and study center|Cochran-Mantel-Haenszel|||Analysis at Week 6||1.36|0.84|0.590
72436574|NCT04517864|144386563|SUPERIORITY||Least Squares Mean Difference|-0.028|STANDARD_ERROR_OF_MEAN|0.0242|||TWO_SIDED|95.0|-0.076|0.02||There was no formal statistical hypothesis testing for this study, and hence there was no P-value.|Mixed Models Analysis|Linear mixed-effects model: baseline, treatment group, visit and treatment group by visit interaction as fixed effects; participant as a random effect||Month 6||0.020|-0.076|
72436575|NCT04517864|144386563|SUPERIORITY||Least Squares Mean Difference|0.003|STANDARD_ERROR_OF_MEAN|0.0261|||TWO_SIDED|95.0|-0.049|0.056||There was no formal statistical hypothesis testing for this study, and hence there was no P-value.|Mixed Models Analysis|Linear mixed-effects model: baseline, treatment group, visit and treatment group by visit interaction as fixed effects; participant as a random effect||Month 9||0.056|-0.049|
72436576|NCT01049503|144386593|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||"The softwares GraphPad InStat version 3.0 for Windows and GraphPad Prism version 4.0 for Windows (GraphPad Software, La Jolla, Ca, USA) were used. Data were checked for normality and homogeneity using Kolmogorov and Smirnov and Bartlett tests, respectively.~Data were analyzed by 2-way RM-ANOVA after logarithmic transformation and Bonferroni's test."||||<0.05
72436577|NCT01049503|144386594|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Kruskal-Wallis|||The softwares GraphPad InStat version 3.0 for Windows and GraphPad Prism version 4.0 for Windows (GraphPad Software, La Jolla, Ca, USA) were used. Data were checked for normality and homogeneity using Kolmogorov; Smirnov and Bartlett tests, respectively. Data from the clinical exams were evaluated by Kruskal-Wallis' test.||||<0.05
72436578|NCT01049503|144386595|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Kruskal-Wallis|||The softwares GraphPad InStat version 3.0 for Windows and GraphPad Prism version 4.0 for Windows (GraphPad Software, La Jolla, Ca, USA) were used. Data were checked for normality and homogeneity using Kolmogorov; Smirnov and Bartlett tests, respectively.Data from the clinical exams were evaluated by Kruskal-Wallis' test.||||<0.05
72436579|NCT01049503|144386596|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||ANOVA|||"The softwares GraphPad InStat version 3.0 for Windows and GraphPad Prism version 4.0 for Windows (GraphPad Software, La Jolla, Ca, USA) were used. Data were checked for normality and homogeneity using Kolmogorov and Smirnov and Bartlett tests, respectively.~Data were analyzed by One-way ANOVA after logarithmic transformation and Tukey's test."||||<0.05
72494693|NCT00523991|144518852|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.16||||0.961||95.0|-6.52|6.84||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms for treatment, site, and work productivity at baseline~Mean Difference (Final Values) means difference in LSMeans"||tiotropium versus placebo||6.84|-6.52|0.961
72558349|NCT01438060|144646272|SUPERIORITY_OR_OTHER||Response ratio|1.1||||0.374|TWO_SIDED|95.0|0.89|1.37||CMH test with controlling for treatment and study center|Cochran-Mantel-Haenszel|||Analysis at Week 8||1.37|0.89|0.374
72558350|NCT01438060|144646272|SUPERIORITY_OR_OTHER||Response ratio|1.15||||0.175|TWO_SIDED|95.0|0.94|1.41||CMH test with controlling for treatment and study center|Cochran-Mantel-Haenszel|||Analysis at Week 10||1.41|0.94|0.175
72558351|NCT01438060|144646273|SUPERIORITY_OR_OTHER||Response ratio|0.88||||0.753|TWO_SIDED|95.0|0.41|1.92||CMH test with controlling for treatment and study center|Cochran-Mantel-Haenszel|||Analysis at week 1||1.92|0.41|0.753
72558352|NCT01438060|144646273|SUPERIORITY_OR_OTHER||Response ratio|0.9||||0.6|TWO_SIDED|95.0|0.62|1.32||CMH test with controlling for treatment and study center|Cochran-Mantel-Haenszel|||Analysis at week 2||1.32|0.62|0.600
72494694|NCT00523991|144518853|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.9||||0.158||95.0|-11.73|1.94||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms for treatment, site, and work productivity at baseline~Mean Difference (Final Values) means difference in LSMeans"||tiotropium versus placebo||1.94|-11.73|0.158
72494695|NCT00523991|144518855|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.74||||0.469||95.0|-3.01|6.49||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms for treatment, site, and work productivity at baseline~Mean Difference (Final Values) means difference in LSMeans"||tiotropium versus placebo||6.49|-3.01|0.469
72494696|NCT00523991|144518856|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.79||||0.079||95.0|-0.68|12.26||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms for treatment, site, and work productivity at baseline~Mean Difference (Final Values) means difference in LSMeans"||tiotropium versus placebo||12.26|-0.68|0.079
72494697|NCT00523991|144518857|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.1||||0.051||95.0|-0.02|8.23||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms for treatment, site, and work productivity at baseline~Mean Difference (Final Values) means difference in LSMeans"||tiotropium versus placebo||8.23|-0.02|0.051
72494698|NCT00523991|144518858|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.43||||0.075||95.0|-0.35|7.21||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms for treatment, site, and work productivity at baseline~Mean Difference (Final Values) means difference in LSMeans"||tiotropium versus placebo||7.21|-0.35|0.075
72494699|NCT00523991|144518859|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.5||||0.306||95.0|-1.39|4.38||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|terms for treatment, site, and work productivity at baseline Mean Difference (Final Values) means difference in LSMeans||tiotropium versus placebo||4.38|-1.39|0.306
72494700|NCT00523991|144518860|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.33||||0.363||95.0|-7.39|2.73||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms for treatment, site, and work productivity at baseline~Mean Difference (Final Values) means difference in LSMeans"||tiotropium versus placebo||2.73|-7.39|0.363
72494701|NCT00523991|144518862|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01||||0.668||95.0|-0.03|0.02||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|terms for treatment, site, and logarithm of baseline value Mean Difference (Final Values) means difference in LSMeans||tiotropium versus placebo||0.02|-0.03|0.668
72494702|NCT00523991|144518863|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.78||95.0|-0.02|0.03||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms for treatment, site, and logarithm of baseline value~Mean Difference (Final Values) means difference in LSMeans"||tiotropium versus placebo||0.03|-0.02|0.780
72558353|NCT01438060|144646273|SUPERIORITY_OR_OTHER||Response ratio|0.93||||0.673|TWO_SIDED|95.0|0.65|1.31||CMH test with controlling for treatment and study center|Cochran-Mantel-Haenszel|||Analysis at week 3||1.31|0.65|0.673
72494703|NCT00523991|144518864|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01||||0.61||95.0|-0.03|0.02||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms for treatment, site, and logarithm of baseline value~Mean Difference (Final Values) means difference in LSMeans"||tiotropium versus placebo||0.02|-0.03|0.610
72494704|NCT00523991|144518865|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01||||0.554||95.0|-0.02|0.04||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms for treatment, site, and logarithm of baseline value~Mean Difference (Final Values) means difference in LSMeans"||tiotropium versus placebo||0.04|-0.02|0.554
72494705|NCT00523991|144518866|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01||||0.549||95.0|-0.02|0.04||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms for treatment, site, and logarithm of baseline value~Mean Difference (Final Values) means difference in LSMeans"||tiotropium versus placebo||0.04|-0.02|0.549
72494706|NCT00523991|144518867|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01||||0.568||95.0|-0.02|0.04||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms for treatment, site, and logarithm of baseline value~Mean Difference (Final Values) means difference in LSMeans"||tiotropium versus placebo||0.04|-0.02|0.568
72494707|NCT00523991|144518869|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.06||||0.358||95.0|-0.18|0.07||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms for treatment, site, and logarithm of baseline value~Mean Difference (Final Values) means difference in LSMeans"||tiotropium versus placebo||0.07|-0.18|0.358
72558354|NCT01438060|144646273|SUPERIORITY_OR_OTHER||Response ratio|0.83||||0.255|TWO_SIDED|95.0|0.6|1.14||CMH test with controlling for treatment and study center|Cochran-Mantel-Haenszel|||Analysis at week 4||1.14|0.60|0.255
72558355|NCT01438060|144646273|SUPERIORITY_OR_OTHER||Response ratio|0.99||||0.958|TWO_SIDED|95.0|0.74|1.33||CMH test with controlling for treatment and study center|Cochran-Mantel-Haenszel|||Analysis at week 6||1.33|0.74|0.958
72558356|NCT01438060|144646273|SUPERIORITY_OR_OTHER||Response ratio|0.92||||0.525|TWO_SIDED|95.0|0.71|1.19||CMH test with controlling for treatment and study center|Cochran-Mantel-Haenszel|||Analysis at week 8||1.19|0.71|0.525
72558357|NCT01438060|144646273|SUPERIORITY_OR_OTHER||Response ratio|1.07||||0.602|TWO_SIDED|95.0|0.82|1.4||CMH test with controlling for treatment and study center|Cochran-Mantel-Haenszel|||Analysis at week 10||1.40|0.82|0.602
72558358|NCT01438060|144646277|SUPERIORITY_OR_OTHER|||||||0.133||95.0||||CMH Row Means test with controlling for study center|Cochran-Mantel-Haenszel|||Analysis at Week 1||||0.133
72558359|NCT01438060|144646277|SUPERIORITY_OR_OTHER|||||||0.282||95.0||||CMH Row Means test with controlling for study center|Cochran-Mantel-Haenszel|||Analysis at Week 2||||0.282
72558360|NCT01438060|144646277|SUPERIORITY_OR_OTHER|||||||0.571||95.0||||CMH Row Means test with controlling for study center|Cochran-Mantel-Haenszel|||Analysis at Week 3||||0.571
72558361|NCT01438060|144646277|SUPERIORITY_OR_OTHER|||||||0.895||95.0||||CMH Row Means test with controlling for study center|Cochran-Mantel-Haenszel|||Analysis at Week 4||||0.895
72558362|NCT01438060|144646277|SUPERIORITY_OR_OTHER|||||||0.817||95.0||||CMH Row Means test with controlling for study center|Cochran-Mantel-Haenszel|||Analysis at Week 6||||0.817
72558363|NCT01438060|144646277|SUPERIORITY_OR_OTHER|||||||0.795||95.0||||CMH Row Means test with controlling for study center|Cochran-Mantel-Haenszel|||Analysis at Week 8||||0.795
72558364|NCT01438060|144646277|SUPERIORITY_OR_OTHER|||||||0.564||95.0||||CMH Row Means test with controlling for study center|Cochran-Mantel-Haenszel|||Analysis at Week 10||||0.564
72558365|NCT01438060|144646279|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.23||||0.733|TWO_SIDED|95.0|-1.08|1.54|||ANCOVA|||Analysis at baseline||1.54|-1.08|0.733
72558366|NCT01438060|144646279|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.35||||0.001|TWO_SIDED|95.0|-2.16|-0.54|||ANOVA|||Analysis at Week 10||-0.54|-2.16|0.001
72384411|NCT00408629|144276470|SUPERIORITY_OR_OTHER|||||||0.032||||||Testing of ranked secondary measures was only started if significant group differences existed for both co-primary measures. Significant results for higher-ranked measure were needed to test next lower-ranked measure to control for multiple testing.|Cochran-Mantel-Haenszel|Stratification levels for Cochran-Mantel-Haenszel = prior anti-TNF versus anti-TNF-naive.||The Cochran-Mantel-Haenszel test was used to test the null hypothesis of no difference between adalimumab and placebo. Treatment differences were deemed statistically significant at a significance level of 0.05.||||0.032
72436580|NCT01049503|144386597|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Kruskal-Wallis|||The softwares GraphPad InStat version 3.0 for Windows and GraphPad Prism version 4.0 for Windows (GraphPad Software, La Jolla, Ca, USA) were used. Data were checked for normality and homogeneity using Kolmogorov; Smirnov and Bartlett tests, respectively. Data from fluorescence loss were evaluated by Kruskal-Wallis and Dunn's tests.||||<0.05
72558367|NCT01442376|144646317|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin of 15% at an alpha level of 2.5% in a 1-sided test (equivalent to 5.0% 2-sided test) to reject the null hypothesis that the study drug was inferior to the active control drug by more than the non-inferiority margin.|Risk Difference (RD)|0.36|||||TWO_SIDED|97.5|-11.7|12.4||||||The stratum adjusted Mantel-Haenszel method was used to compute the confidence interval (CI) of the difference in proportion. If the lower bound of the 97.5% CI of either the difference (CR0-24h palonosetron 20 mcg/kg - CR0-24h ondansetron) or the difference (CR0-24h palonosetron 10 mcg/kg - CR0-24h ondansetron) was strictly superior to the non-inferiority margin (δ=-0.15) then the null hypothesis (H0) was rejected. A power of 80% was used for sample size computation.||12.4|-11.7|
72558368|NCT01442376|144646317|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin of 15% at an alpha level of 2.5% in a 1-sided test (equivalent to 5.0% 2-sided test) to reject the null hypothesis that the study drug was inferior to the active control drug by more than the non-inferiority margin.|Risk Difference (RD)|-4.4|||||TWO_SIDED|97.5|-16.4|7.6||||||The stratum adjusted Mantel-Haenszel method was used to compute the confidence interval (CI) of the difference in proportion. If the lower bound of the 97.5% CI of either the difference (CR0-24h palonosetron 20 mcg/kg - CR0-24h ondansetron) or the difference (CR0-24h palonosetron 10 mcg/kg - CR0-24h ondansetron) was strictly superior to the non-inferiority margin (δ=-0.15) then the null hypothesis (H0) was rejected. A power of 80% was used for sample size computation.||7.6|-16.4|
72558369|NCT03499873|144646319|EQUIVALENCE|90% CI on the Test-to-Reference difference for the proportion of subjects with cure should be contained within the interval \[-0.20, +0.20\]|Mean Difference (Net)|-0.026|||||TWO_SIDED|90.0|-0.124|0.073||||||||0.073|-0.124|
72558370|NCT03499873|144646319|SUPERIORITY|||||||0.0005|||||||ANOVA|||||||0.0005
72558371|NCT03499873|144646319|SUPERIORITY|||||||0.0003|||||||ANOVA|||||||0.0003
72558372|NCT01075516|144646327|OTHER|Continuous data summarized as mean ± Standard Deviation (SD). For cost data Wilcoxon rank-sum test was used to compare costs across groups. The analysis evaluated HCS perspective of group membership impact (SC vs RM) on total health care cost, adjusting for covariates that were significantly different between the groups at the .2 significance level. Differences between the 2 groups were assessed using differences in sample means (point estimates) and t distributions (confidence intervals)|||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
72558373|NCT01075516|144646328|OTHER|Continuous data are summarized as mean ± SD. For cost data the Wilcoxon rank-sum test was used to compare costs across groups. This analysis evaluated the impact of group membership (SC vs RM) on cardiovascular hospitalization timeframe (outcome), adjusting for covariates that were significantly different between the groups at the .2 significance level. Differences between the 2 groups were assessed using differences in sample means (point estimates) and t distributions (confidence intervals).||||||0.003|||||||Wilcoxon (Mann-Whitney)|||||||0.003
72558374|NCT01075516|144646329|OTHER|Continuous data are summarized as mean ± SD. This analysis evaluated the impact of group membership (SC vs RM) on total health care cost (outcome), adjusting for covariates that were significantly different between the groups at the .2 significance level. However, as the arithmetic mean is the most informative measurement for policy decisions, differences between the 2 groups were assessed using differences in sample means (point estimates) and t distributions (confidence intervals).||||||0.8||||||Comparison of utility at baseline from the EQ-5D-3L questionnaire.|t-test, 2 sided|||For the patient perspective, the quality of life associated with the 2 strategies was assessed. Quality of life is reported as utility values from the EuroQoL Group 5-Dimension 3-Level Self-Report (EQ-5D-3L) questionnaire and quality adjusted life years (QALYs) were based on utility (patients' preferences). The EQ-5D-3L questionnaire was administered to each patient at baseline and at 12 months in order to calculate utility values (from 0 to 1).||||0.80
72436581|NCT01049503|144386598|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||ANOVA|||The softwares GraphPad InStat version 3.0 for Windows and GraphPad Prism version 4.0 for Windows (GraphPad Software, La Jolla, Ca, USA) were used. Data were checked for normality and homogeneity using Kolmogorov; Smirnov and Bartlett tests, respectively. Data from lesion area were evaluated by ANOVA after logarithmic transformation and Tukey's test.||||<0.05
72436582|NCT01049503|144386599|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Kruskal-Wallis|||GraphPad Prism version 4.0 for Windows (GraphPad Software, La Jolla, Ca, USA) were used. Data were checked for normality and homogeneity using Kolmogorov; Smirnov and Bartlett tests, respectively.Data from the clinical exams were evaluated by Kruskal-Wallis' test.||||<0.05
72436583|NCT00726596|144386600|SUPERIORITY|||||||0.6789|||||||t-test, 1 sided|||||||.6789
72436584|NCT02974634|144386605|SUPERIORITY||Slope|1.04|STANDARD_ERROR_OF_MEAN|2.32||0.06|TWO_SIDED|95.0|-3.5|5.6||Comparison of intervention and usual care at 6 month follow up|t-test, 2 sided||Interaction coefficient (slope) of arm by time period (6 months follow up vs baseline) from mixed linear model|||5.6|-3.5|0.06
72436585|NCT02974634|144386606|SUPERIORITY||Slope|0.34|STANDARD_ERROR_OF_MEAN|0.29||0.68|TWO_SIDED|95.0|-0.24|0.91||Comparison of intervention and usual care at 6 month follow up|t-test, 2 sided||Interaction coefficient (slope) of arm by time period (6 months follow up vs baseline) from mixed linear model|||0.91|-0.24|0.68
72618760|NCT01026038|144768112|SUPERIORITY_OR_OTHER||Percent Difference|0.0|||||TWO_SIDED|95.0|-3.7|6.3||||||Serotype 6B: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 13vPnC/13vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/7vPnC/13vPnC along with exact 2-sided 95% CI.||6.3|-3.7|
72436586|NCT02962674|144386613|SUPERIORITY|||||||0.004|||||||t-test, 1 sided|||"The null and alternative hypotheses associated with this objective was written as:~H0: μ ΔIPSS ≤ 6.5 points HA: μ ΔIPSS \> 6.5 points where μ ΔIPSS was the true underlying value of mean ΔIPSS following a treatment at the 3-month follow-up visit and 6.5 points was an objective performance goal (OPG). The objective was met at a given time point by rejecting the null hypothesis in a one-sided t-test at the 5% significance level."||||0.004
72436587|NCT01124188|144386628|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.07|||||TWO_SIDED|95.0|0.63|1.8||||||||1.80|0.63|
72436588|NCT01124188|144386629|SUPERIORITY_OR_OTHER|||||||0.49|||||||Mixed Models Analysis|||||||.49
72436589|NCT01124188|144386630|SUPERIORITY_OR_OTHER|||||||0.88|||||||Mixed Models Analysis|||||||0.88
72436590|NCT01227278|144386653|SUPERIORITY_OR_OTHER||Rate ratio|1.03||||0.941|TWO_SIDED|95.0|0.67|1.58|||Van Elteren Test|Day 1 to 393: Van Elteren test was used to compare the two arms.|95 percent (%) confidence interval (CI) for rate ratio was based on normal approximation assuming rate with Poisson distribution.|||1.58|0.67|0.941
72494708|NCT00523991|144518870|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.08||||0.219||95.0|-0.2|0.05||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|Mean Difference (Final Values) means difference in LSMeans||tiotropium versus placebo||0.05|-0.20|0.219
72436591|NCT04035668|144386663|SUPERIORITY||Mean Difference (Final Values)|-2.86||||0.002|TWO_SIDED|95.0|-4.71|-1.01||one-sided p-value|MMRM||Difference (Any remibrutinib - Placebo)|||-1.01|-4.71|0.002
72436592|NCT04035668|144386663|OTHER||Mean Difference (Final Values)|-1.0|||||TWO_SIDED|95.0|-3.24|1.25|||MMRM||Difference (remibrutinib 100 mg qd - remibrutinib 100 mg bid)|||1.25|-3.24|
72436593|NCT04035668|144386664|SUPERIORITY||Mean Difference (Final Values)|-0.99||||0.065|TWO_SIDED|95.0|-2.29|0.3||one-sided p-value|MMRM||Difference (Any remibrutinib - Placebo)|Week 2||0.30|-2.29|0.065
72436594|NCT04035668|144386664|SUPERIORITY||Mean Difference (Final Values)|-1.76||||0.01|TWO_SIDED|95.0|-3.24|-0.29||one-sided p-value|MMRM||Difference (Any remibrutinib - Placebo)|Week 4||-0.29|-3.24|0.010
72436595|NCT04035668|144386664|SUPERIORITY||Mean Difference (Final Values)|-0.47||||0.289|TWO_SIDED|95.0|-2.17|1.22||one-sided p-value|MMRM||Difference (Any remibrutinib - Placebo)|Week 8||1.22|-2.17|0.289
72618761|NCT01026038|144768112|SUPERIORITY_OR_OTHER||Percent difference|0.0|||||TWO_SIDED|95.0|-3.6|6.4||||||Serotype 6B: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 13vPnC/13vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/13vPnC/13vPnC along with exact 2-sided 95% CI.||6.4|-3.6|
72436596|NCT04035668|144386664|SUPERIORITY||Mean Difference (Final Values)|-1.19||||0.093|TWO_SIDED|95.0|-2.97|0.59||one-sided p-value|MMRM||Difference (Any remibrutinib - Placebo)|Week 12||0.59|-2.97|0.093
72436597|NCT04035668|144386664|SUPERIORITY||Mean Difference (Final Values)|-1.13||||0.094|TWO_SIDED|95.0|-2.84|0.57||one-sided p-value|MMRM||Difference (Any remibrutinib - Placebo)|Week 16||0.57|-2.84|0.094
72436598|NCT04035668|144386664|SUPERIORITY||Mean Difference (Final Values)|-1.99||||0.012|TWO_SIDED|95.0|-3.71|-0.28||one-sided p-value|MMRM|||Week 20|Difference (Any remibrutinib - Placebo)|-0.28|-3.71|0.012
72436599|NCT04035668|144386664|OTHER||Mean Difference (Final Values)|-0.63|||||TWO_SIDED|95.0|-2.1|0.84|||MMRM||Difference (remibrutinib 100 mg qd - remibrutinib 100 mg bid)|Week 2||0.84|-2.10|
72436600|NCT04035668|144386664|OTHER||Mean Difference (Final Values)|-0.03|||||TWO_SIDED|95.0|-1.75|1.69|||MMRM||Difference (remibrutinib 100 mg qd - remibrutinib 100 mg bid)|Week 4||1.69|-1.75|
72436601|NCT04035668|144386664|OTHER||Mean Difference (Final Values)|0.19|||||TWO_SIDED|95.0|-1.83|2.21|||MMRM||Difference (remibrutinib 100 mg qd - remibrutinib 100 mg bid)|Week 8||2.21|-1.83|
72436602|NCT04035668|144386664|OTHER||Mean Difference (Final Values)|-1.1|||||TWO_SIDED|95.0|-3.2|1.01|||MMRM||Difference (remibrutinib 100 mg qd - remibrutinib 100 mg bid)|Week 12||1.01|-3.20|
72436603|NCT04035668|144386664|OTHER||Mean Difference (Final Values)|-1.45|||||TWO_SIDED|95.0|-3.5|0.6|||MMRM||Difference (remibrutinib 100 mg qd - remibrutinib 100 mg bid)|Week 16||0.60|-3.50|
72436604|NCT04035668|144386664|OTHER||Mean Difference (Final Values)|-1.14|||||TWO_SIDED|95.0|-3.22|0.95|||MMRM||Difference (remibrutinib 100 mg qd - remibrutinib 100 mg bid)|Week 20||0.95|-3.22|
72436605|NCT04035668|144386665|SUPERIORITY||Mean Difference (Final Values)|-0.03||||0.46|TWO_SIDED|95.0|-0.69|0.62||one-sided p-value|MMRM||Difference (Any remibrutinib - Placebo)|Week 2||0.62|-0.69|0.460
72436606|NCT04035668|144386665|SUPERIORITY||Mean Difference (Final Values)|-0.08||||0.418|TWO_SIDED|95.0|-0.82|0.66||one-sided p-value|MMRM||Difference (Any remibrutinib - Placebo)|Week 4||0.66|-0.82|0.418
72558375|NCT01075516|144646329|OTHER|Continuous data are summarized as mean ± SD. This analysis evaluated the impact of group membership (SC vs RM) on total health care cost (outcome), adjusting for covariates that were significantly different between the groups at the .2 significance level. However, as the arithmetic mean is the most informative measurement for policy decisions, differences between the 2 groups were assessed using differences in sample means (point estimates) and t distributions (confidence intervals).||||||0.38||||||Comparison of utility at 12 months from the EQ-5D-3L questionnaire.|t-test, 2 sided|||For the patient perspective, the quality of life associated with the 2 strategies was assessed. Quality of life is reported as utility values from the EQ-5D-3L questionnaire and quality adjusted life years (QALYs) were based on utility (patients' preferences). The EQ-5D-3L questionnaire was administered to each patient at baseline and at 12 months in order to calculate utility values (from 0 to 1).||||0.38
72618762|NCT01026038|144768112|SUPERIORITY_OR_OTHER||Percent Difference|0.0|||||TWO_SIDED|95.0|-6.4|6.5||||||Serotype 6B: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 7vPnC/7vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/13vPnC/13vPnC along with exact 2-sided 95% CI.||6.5|-6.4|
72384412|NCT00408629|144276471|SUPERIORITY_OR_OTHER|||||||0.009||||||Testing of ranked secondary measures was only started if significant group differences existed for both co-primary measures. Significant results for higher-ranked measure was needed to test next lower-ranked measure to control for multiple testing.|Cochran-Mantel-Haenszel|Stratification levels for Cochran-Mantel-Haenszel = prior anti-TNF versus anti-TNF-naive.||The Cochran-Mantel-Haenszel test was used to test the null hypothesis of no difference between adalimumab and placebo. Treatment differences were deemed statistically significant at a significance level of 0.05.||||0.009
72436607|NCT04035668|144386665|SUPERIORITY||Mean Difference (Final Values)|-0.03||||0.466|TWO_SIDED|95.0|-0.76|0.7||one-sided p-value|MMRM||Difference (Any remibrutinib - Placebo)|Week 8||0.70|-0.76|0.466
72436608|NCT04035668|144386665|SUPERIORITY||Mean Difference (Final Values)|0.06||||0.56|TWO_SIDED|95.0|-0.67|0.79||one-sided p-value|MMRM||Difference (Any remibrutinib - Placebo)|Week 12||0.79|-0.67|0.560
72436609|NCT04035668|144386665|SUPERIORITY||Mean Difference (Final Values)|0.13||||0.616|TWO_SIDED|95.0|-0.73|0.99||one-sided p-value|MMRM||Difference (Any remibrutinib - Placebo)|Week 16||0.99|-0.73|0.616
72436610|NCT04035668|144386665|SUPERIORITY||Mean Difference (Final Values)|0.13||||0.581|TWO_SIDED|95.0|-0.81|0.99||one-sided p-value|MMRM|||Week 20|Difference (Any remibrutinib - Placebo)|0.99|-0.81|0.581
72436611|NCT04035668|144386665|SUPERIORITY||Mean Difference (Final Values)|0.17||||0.663|TWO_SIDED|95.0|-0.62|0.96||one-sided p-value|MMRM||Difference (Any remibrutinib - Placebo)|Week 24||0.96|-0.62|0.663
72436612|NCT04035668|144386665|OTHER||Mean Difference (Final Values)|-0.62|||||TWO_SIDED|95.0|-1.35|0.11|||MMRM||Difference (remibrutinib 100 mg qd - remibrutinib 100 mg bid)|Week 2||0.11|-1.35|
72436613|NCT04035668|144386665|OTHER||Mean Difference (Final Values)|-0.58|||||TWO_SIDED|95.0|-1.42|0.26|||MMRM||Difference (remibrutinib 100 mg qd - remibrutinib 100 mg bid)|Week 4||0.26|-1.42|
72436614|NCT04035668|144386665|OTHER||Mean Difference (Final Values)|-0.45|||||TWO_SIDED|95.0|-1.31|0.42|||MMRM||Difference (remibrutinib 100 mg qd - remibrutinib 100 mg bid)|Week 8||0.42|-1.31|
72436615|NCT04035668|144386665|OTHER||Mean Difference (Final Values)|-0.57|||||TWO_SIDED|95.0|-1.44|0.31|||MMRM||Difference (remibrutinib 100 mg qd - remibrutinib 100 mg bid)|Week 12||0.31|-1.44|
72436616|NCT04035668|144386665|OTHER||Mean Difference (Final Values)|-0.37|||||TWO_SIDED|95.0|-1.39|0.65|||MMRM||Difference (remibrutinib 100 mg qd - remibrutinib 100 mg bid)|Week 16||0.65|-1.39|
72436617|NCT04035668|144386665|OTHER||Mean Difference (Final Values)|-0.37|||||TWO_SIDED|95.0|-1.39|0.65|||MMRM||Difference (remibrutinib 100 mg qd - remibrutinib 100 mg bid)|Week 20||0.65|-1.39|
72436618|NCT04035668|144386665|OTHER||Mean Difference (Final Values)|-0.4|||||TWO_SIDED|95.0|-1.37|0.57|||MMRM||Difference (remibrutinib 100 mg qd - remibrutinib 100 mg bid)|Week 24||0.57|-1.37|
72436619|NCT04035668|144386666|SUPERIORITY||Mean Difference (Final Values)|-2.73||||0.94|TWO_SIDED|95.0|-6.18|0.73||one-sided p-value|MMRM||Difference (Any remibrutinib - Placebo)|Week 2||0.73|-6.18|0.940
72436620|NCT04035668|144386666|SUPERIORITY||Mean Difference (Final Values)|0.89||||0.322|TWO_SIDED|95.0|-2.95|4.74||one-sided p-value|MMRM||Difference (Any remibrutinib - Placebo)|Week 4||4.74|-2.95|0.322
72436621|NCT04035668|144386666|SUPERIORITY||Mean Difference (Final Values)|-1.36||||0.753|TWO_SIDED|95.0|-5.32|2.59||one-sided p-value|MMRM||Difference (Any remibrutinib - Placebo)|Week 8||2.59|-5.32|0.753
72436622|NCT04035668|144386666|SUPERIORITY||Mean Difference (Final Values)|-2.74||||0.891|TWO_SIDED|95.0|-7.13|1.66||one-sided p-value|MMRM||Difference (Any remibrutinib - Placebo)|Week 12||1.66|-7.13|0.891
72436623|NCT04035668|144386666|SUPERIORITY||Mean Difference (Final Values)|-3.88||||0.941|TWO_SIDED|95.0|-8.77|1.01||one-sided p-value|MMRM||Difference (Any remibrutinib - Placebo)|Week 16||1.01|-8.77|0.941
72436624|NCT04035668|144386666|SUPERIORITY||Mean Difference (Final Values)|1.39||||0.304|TWO_SIDED|95.0|-4.01|6.79||one-sided p-value|MMRM|||Week 20|Difference (Any remibrutinib - Placebo)|6.79|-4.01|0.304
72436625|NCT04035668|144386666|SUPERIORITY||Mean Difference (Final Values)|-1.05||||0.64|TWO_SIDED|95.0|-6.89|4.79||one-sided p-value|MMRM||Difference (Any remibrutinib - Placebo)|Week 24||4.79|-6.89|0.640
72436626|NCT04035668|144386666|OTHER||Mean Difference (Final Values)|2.32|||||TWO_SIDED|95.0|-1.44|6.07|||MMRM||Difference (remibrutinib 100 mg qd - remibrutinib 100 mg bid)|Week 2||6.07|-1.44|
72436627|NCT04035668|144386666|OTHER||Mean Difference (Final Values)|0.86|||||TWO_SIDED|95.0|-3.46|5.18|||MMRM||Difference (remibrutinib 100 mg qd - remibrutinib 100 mg bid)|Week 4||5.18|-3.46|
72436628|NCT04035668|144386666|OTHER||Mean Difference (Final Values)|0.2|||||TWO_SIDED|95.0|-4.43|4.83|||MMRM||Difference (remibrutinib 100 mg qd - remibrutinib 100 mg bid)|Week 8||4.83|-4.43|
72436629|NCT04035668|144386666|OTHER||Mean Difference (Final Values)|0.63|||||TWO_SIDED|95.0|-4.53|5.78|||MMRM||Difference (remibrutinib 100 mg qd - remibrutinib 100 mg bid)|Week 12||5.78|-4.53|
72436630|NCT04035668|144386666|OTHER||Mean Difference (Final Values)|1.11|||||TWO_SIDED|95.0|-4.6|6.82|||MMRM||Difference (remibrutinib 100 mg qd - remibrutinib 100 mg bid)|Week 16||6.82|-4.60|
72436631|NCT04035668|144386666|OTHER||Mean Difference (Final Values)|5.69|||||TWO_SIDED|95.0|-0.66|12.04|||MMRM||Difference (remibrutinib 100 mg qd - remibrutinib 100 mg bid)|Week 20||12.04|-0.66|
72494709|NCT00523991|144518871|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.05||||0.518||95.0|-0.1|0.19||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms for treatment, site, and logarithm of baseline value~Mean Difference (Final Values) means difference in LSMeans"||tiotropium versus placebo||0.19|-0.10|0.518
72618763|NCT01026038|144768112|SUPERIORITY_OR_OTHER||Percent Difference|0.0|||||TWO_SIDED|95.0|-3.6|6.6||||||Serotype 9V: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 13vPnC/13vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/7vPnC/13vPnC along with exact 2-sided 95% CI.||6.6|-3.6|
72384413|NCT00408629|144276472|SUPERIORITY_OR_OTHER|||||||0.013||||||Testing of ranked secondary measures was only started if significant group differences existed for both co-primary measures. Significant results for higher-ranked measure was needed to test next lower-ranked measure to control for multiple testing.|Cochran-Mantel-Haenszel|Stratification levels for Cochran-Mantel-Haenszel = prior anti-TNF versus anti-TNF-naive.||The Cochran-Mantel-Haenszel test was used to test the null hypothesis of no difference between adalimumab and placebo. Treatment differences were deemed statistically significant at a significance level of 0.05.||||0.013
72384414|NCT00408629|144276473|SUPERIORITY_OR_OTHER|||||||0.035||||||Testing of ranked secondary measures was only started if significant group differences existed for both co-primary measures. Significant results for higher-ranked measure was needed to test next lower-ranked measure to control for multiple testing.|Cochran-Mantel-Haenszel|Stratification levels for Cochran-Mantel-Haenszel = prior anti-TNF versus anti-TNF-naive.||The Cochran-Mantel-Haenszel test was used to test the null hypothesis of no difference between adalimumab and placebo. Treatment differences were deemed statistically significant at a significance level of 0.05.||||0.035
72384415|NCT00408629|144276474|SUPERIORITY_OR_OTHER|||||||0.058||||||Testing of ranked secondary measures was only started if significant group differences existed for both co-primary measures. Significant results for higher-ranked measure was needed to test next lower-ranked measure to control for multiple testing.|Cochran-Mantel-Haenszel|Stratification levels for Cochran-Mantel-Haenszel = prior anti-TNF versus anti-TNF-naive.||The Cochran-Mantel-Haenszel test was used to test the null hypothesis of no difference between adalimumab and placebo. Treatment differences were deemed statistically significant at a significance level of 0.05.||||0.058
72384416|NCT00408629|144276475|SUPERIORITY_OR_OTHER|||||||0.028||||||Testing of ranked secondary measures was only started if significant group differences existed for both co-primary measures. Significant results for higher-ranked measure was needed to test next lower-ranked measure to control for multiple testing.|Cochran-Mantel-Haenszel|Stratification levels for Cochran-Mantel-Haenszel = prior anti-TNF versus anti-TNF-naive.||The Cochran-Mantel-Haenszel test was used to test the null hypothesis of no difference between adalimumab and placebo. Treatment differences were deemed statistically significant at a significance level of 0.05.||||0.028
72384417|NCT00408629|144276476|SUPERIORITY_OR_OTHER|||||||0.006||||||Testing of ranked secondary measures was only started if significant group differences existed for both co-primary measures. Significant results for higher-ranked measure was needed to test next lower-ranked measure to control for multiple testing.|Cochran-Mantel-Haenszel|Stratification levels for Cochran-Mantel-Haenszel = prior anti-TNF versus anti-TNF-naive.||The Cochran-Mantel-Haenszel test was used to test the null hypothesis of no difference between adalimumab and placebo. Treatment differences were deemed statistically significant at a significance level of 0.05.||||0.006
72384418|NCT00408629|144276477|SUPERIORITY_OR_OTHER|||||||0.035||||||Testing of ranked secondary measures was only started if significant group differences existed for both co-primary measures. Significant results for higher-ranked measure was needed to test next lower-ranked measure to control for multiple testing.|Cochran-Mantel-Haenszel|Stratification levels for Cochran-Mantel-Haenszel = prior anti-TNF versus anti-TNF-naive.||The Cochran-Mantel-Haenszel test was used to test the null hypothesis of no difference between adalimumab and placebo. Treatment differences were deemed statistically significant at a significance level of 0.05.||||0.035
72384419|NCT00408629|144276478|SUPERIORITY_OR_OTHER|||||||0.002||||||Testing of ranked secondary measures was only started if significant group differences existed for both co-primary measures. Significant results for higher-ranked measure was needed to test next lower-ranked measure to control for multiple testing.|Cochran-Mantel-Haenszel|Stratification levels for Cochran-Mantel-Haenszel = prior anti-TNF versus anti-TNF-naive.||The Cochran-Mantel-Haenszel test was used to test the null hypothesis of no difference between adalimumab and placebo. Treatment differences were deemed statistically significant at a significance level of 0.05.||||0.002
72384420|NCT00408629|144276479|SUPERIORITY_OR_OTHER|||||||0.007||||||Testing of ranked secondary measures was only started if significant group differences existed for both co-primary measures. Significant results for higher-ranked measure was needed to test next lower-ranked measure to control for multiple testing.|Cochran-Mantel-Haenszel|Stratification levels for Cochran-Mantel-Haenszel = prior anti-TNF versus anti-TNF-naive.||The Cochran-Mantel-Haenszel test was used to test the null hypothesis of no difference between adalimumab and placebo. Treatment differences were deemed statistically significant at a significance level of 0.05.||||0.007
72384421|NCT00408629|144276480|SUPERIORITY_OR_OTHER|||||||0.006||||||Testing of ranked secondary measures was only started if significant group differences existed for both co-primary measures. Significant results for higher-ranked measure was needed to test next lower-ranked measure to control for multiple testing.|Cochran-Mantel-Haenszel|Stratification levels for Cochran-Mantel-Haenszel = prior anti-TNF versus anti-TNF-naive.||The Cochran-Mantel-Haenszel test was used to test the null hypothesis of no difference between adalimumab and placebo. Treatment differences were deemed statistically significant at a significance level of 0.05.||||0.006
72494710|NCT00523991|144518872|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.06||||0.455||95.0|-0.09|0.21||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms for treatment, site, and logarithm of baseline value~Mean Difference (Final Values) means difference in LSMeans"||tiotropium versus placebo||0.21|-0.09|0.455
72494711|NCT00523991|144518873|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01||||0.927||95.0|-0.16|0.15||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms for treatment, site, and logarithm of baseline value~Mean Difference (Final Values) means difference in LSMeans"||tiotropium versus placebo||0.15|-0.16|0.927
72558376|NCT01075516|144646329|OTHER|Continuous data are summarized as mean ± SD. This analysis evaluated the impact of group membership (SC vs RM) on total health care cost (outcome), adjusting for covariates that were significantly different between the groups at the .2 significance level. However, as the arithmetic mean is the most informative measurement for policy decisions, differences between the 2 groups were assessed using differences in sample means (point estimates) and t distributions (confidence intervals).||||||0.53|||||||t-test, 2 sided|||For the patient perspective, the quality of life associated with the 2 strategies was assessed. Quality of life is reported as utility values from the EQ-5D-3L questionnaire and quality adjusted life years (QALYs) were based on utility (patients' preferences). The EQ-5D-3L questionnaire was administered to each patient at baseline and at 12 months in order to calculate utility values (from 0 to 1).||||0.53
72558377|NCT00834405|144646330|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-72 and Cmax.|Geometric Test/Ref Ratio x 100|106.0||||||90.0|98.0|114.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||114|98.0|
72558378|NCT00834405|144646331|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-72 and Cmax.|Geometric Test/Ref Ratio x 100|107.0||||||90.0|100.0|115.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||115|100|
72558379|NCT02252016|144646333|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.5|||||TWO_SIDED|95.0|-7.3|23.3||||||The estimated difference (± 95% confidence interval \[CI\]) in percentage of participants experiencing an AE in the Immediate versus Deferred arms was determined.||23.3|-7.3|
72558380|NCT02252016|144646334|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.9||||0.155|TWO_SIDED|95.0|-10.2|1.6|||Miettinen & Nurminen method|||The estimated difference (± 95% CI) in percentage of participants withdrawing from study treatment due to an AE(s) in the Immediate versus Deferred arms was determined.||1.6|-10.2|0.155
72384422|NCT00191906|144276481|SUPERIORITY_OR_OTHER|||||||0.504||95.0||||P-value for Overall. No adjustments for multiple comparisons - not applicable. All statistical tests were performed using a 0.05 significance level.|Repeated Measures|Repeated measures model including terms for baseline, study arm, treatment sequence, visit, treatment, and treatment-by-study-arm interaction.||Least Squares Mean (LSMean) values were calculated from the measurements taken at baseline and at the end of each 4 week therapy period.||||0.504
72384423|NCT00191906|144276482|SUPERIORITY_OR_OTHER|||||||0.97||95.0||||There were no adjustments for multiple comparisons - not applicable. All statistical tests were performed using a 0.05 significance level.|ANCOVA|||ANCOVA model with baseline value, study arm as covariates for ADHD-C versus Normal controls.||||0.970
72384424|NCT00191906|144276483|SUPERIORITY_OR_OTHER|||||||0.579||95.0||||There were no adjustments for multiple comparisons - not applicable. All statistical tests were performed using a 0.05 significance level.|ANCOVA|||ANCOVA model with baseline value, study arm as covariates for ADHD-C+RD versus RD controls.||||0.579
72384425|NCT00191906|144276483|SUPERIORITY_OR_OTHER|||||||0.144||95.0||||There were no adjustments for multiple comparisons - not applicable. All statistical tests are performed using a 0.05 significance level.|ANCOVA|||ANCOVA model with baseline value, study arm as covariates for RD versus RD controls.||||0.144
72384426|NCT00191906|144276484|SUPERIORITY_OR_OTHER|||||||0.005||95.0||||P-value for Overall. There were no adjustments for multiple comparisons - not applicable. All statistical tests were performed using a 0.05 significance level.|Repeated Measures|Repeated measures model including terms for baseline, study arm, treatment sequence, visit, treatment, and treatment by study-arm-interaction.||Least Squares Mean (LSMean) values were calculated from the measurements taken at baseline and at the end of each 4 week therapy period.||||0.005
72384427|NCT00191906|144276485|SUPERIORITY_OR_OTHER|||||||0.097||95.0||||P-value for Overall. There were no adjustments for multiple comparisons - not applicable. All statistical tests were performed using a 0.05 significance level.|Repeated Measures|Repeated measures model including terms for baseline, study arm, treatment sequence, visit, treatment, and treatment-by-study-arm interaction.||Least Squares Mean (LSMean) values were calculated from the measurements taken at baseline and at the end of each 4 week therapy period.||||0.097
72384428|NCT00191906|144276486|SUPERIORITY_OR_OTHER|||||||0.003||95.0||||P-value for Overall. There were no adjustments for multiple comparisons - not applicable. All statistical tests were performed using a 0.05 significance level.|Repeated Measures|Repeated measures model including terms for study arm, treatment sequence, treatment, and treatment-by-study-arm interaction.||Least Squares Mean (LSMean) values were calculated from the measurements taken at baseline and at the end of each 4 week therapy period.||||0.003
72384429|NCT00191906|144276487|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Overall. There were no adjustments for multiple comparisons - not applicable. All statistical tests were performed using a 0.05 significance level.|Repeated Measures|Repeated measures model including terms for baseline, study arm, treatment sequence, visit, treatment, and treatment-by-study-arm interaction.||Least Squares Mean (LSMean) values were calculated from the measurements taken at baseline and at the end of each 4 week therapy period.||||<0.001
72436632|NCT04035668|144386666|OTHER||Mean Difference (Final Values)|3.53|||||TWO_SIDED|95.0|-3.53|10.59|||MMRM||Difference (remibrutinib 100 mg qd - remibrutinib 100 mg bid)|Week 24||10.59|-3.53|
72436633|NCT04035668|144386667|SUPERIORITY||Mean Difference (Final Values)|0.06||||0.494|TWO_SIDED|95.0|-7.84|7.96||one-sided p-value|MMRM||Difference (Any remibrutinib - Placebo)|Week 2||7.96|-7.84|0.494
72558381|NCT00840281|144646336|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model containing factors for sequence of products, subjects within sequence, periods, and products was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|100.0||||||90.0|94.9|105.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%|||105|94.9|
72558382|NCT00840281|144646337|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model containing factors for sequence of products, subjects within sequence, periods, and products was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|101.0||||||90.0|98.6|103.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%|||103|98.6|
72436634|NCT04035668|144386667|SUPERIORITY||Mean Difference (Final Values)|-3.87||||0.866|TWO_SIDED|95.0|-10.81|3.06||one-sided p-value|MMRM||Difference (Any remibrutinib - Placebo)|Week 4||3.06|-10.81|0.866
72436635|NCT04035668|144386667|SUPERIORITY||Mean Difference (Final Values)|-1.82||||0.684|TWO_SIDED|95.0|-9.37|5.73||one-sided p-value|MMRM||Difference (Any remibrutinib - Placebo)|Week 8||5.73|-9.37|0.684
72436636|NCT04035668|144386667|SUPERIORITY||Mean Difference (Final Values)|-4.39||||0.908|TWO_SIDED|95.0|-10.93|2.14||one-sided p-value|MMRM||Difference (Any remibrutinib - Placebo)|Week 12||2.14|-10.93|0.908
72436637|NCT04035668|144386667|SUPERIORITY||Mean Difference (Final Values)|0.13||||0.487|TWO_SIDED|95.0|-8.0|8.26||one-sided p-value|MMRM||Difference (Any remibrutinib - Placebo)|Week 16||8.26|-8.00|0.487
72436638|NCT04035668|144386667|SUPERIORITY||Mean Difference (Final Values)|-3.06||||0.79|TWO_SIDED|95.0|-10.61|4.49||one-sided p-value|MMRM|||Week 20|Difference (Any remibrutinib - Placebo)|4.49|-10.61|0.790
72436639|NCT04035668|144386667|SUPERIORITY||Mean Difference (Final Values)|1.7||||0.34|TWO_SIDED|95.0|-6.48|9.88||one-sided p-value|MMRM||Difference (Any remibrutinib - Placebo)|Week 24||9.88|-6.48|0.340
72436640|NCT04035668|144386667|OTHER||Mean Difference (Final Values)|-0.19|||||TWO_SIDED|95.0|-9.06|8.68|||MMRM||Difference (remibrutinib 100 mg qd - remibrutinib 100 mg bid)|Week 2||8.68|-9.06|
72436641|NCT04035668|144386667|OTHER||Mean Difference (Final Values)|-1.71|||||TWO_SIDED|95.0|-9.59|6.17|||MMRM||Difference (remibrutinib 100 mg qd - remibrutinib 100 mg bid)|Week 4||6.17|-9.59|
72436642|NCT04035668|144386667|OTHER||Mean Difference (Final Values)|-0.3|||||TWO_SIDED|95.0|-9.34|8.74|||MMRM||Difference (remibrutinib 100 mg qd - remibrutinib 100 mg bid)|Week 8||8.74|-9.34|
72436643|NCT04035668|144386667|OTHER||Mean Difference (Final Values)|-3.94|||||TWO_SIDED|95.0|-11.74|3.86|||MMRM||Difference (remibrutinib 100 mg qd - remibrutinib 100 mg bid)|Week 12||3.86|-11.74|
72436644|NCT04035668|144386667|OTHER||Mean Difference (Final Values)|-4.71|||||TWO_SIDED|95.0|-14.34|4.93|||MMRM||Difference (remibrutinib 100 mg qd - remibrutinib 100 mg bid)|Week 16||4.93|-14.34|
72436645|NCT04035668|144386667|OTHER||Mean Difference (Final Values)|-6.29|||||TWO_SIDED|95.0|-15.44|2.87|||MMRM||Difference (remibrutinib 100 mg qd - remibrutinib 100 mg bid)|Week 20||2.87|-15.44|
72494712|NCT00523991|144518874|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01||||0.933||95.0|-0.17|0.16||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms for treatment, site, and logarithm of baseline value~Mean Difference (Final Values) means difference in LSMeans"||tiotropium versus placebo||0.16|-0.17|0.933
72436646|NCT04035668|144386667|OTHER||Mean Difference (Final Values)|-3.92|||||TWO_SIDED|95.0|-14.01|6.16|||MMRM||Difference (remibrutinib 100 mg qd - remibrutinib 100 mg bid)|Week 24||6.16|-14.01|
72436647|NCT04035668|144386668|SUPERIORITY||Mean Difference (Final Values)|0.71||||0.575|TWO_SIDED|95.0|-6.75|8.16||one-sided p-value|MMRM||Difference (Any remibrutinib - Placebo)|Week 2||8.16|-6.75|0.575
72436648|NCT04035668|144386668|SUPERIORITY||Mean Difference (Final Values)|-1.98||||0.294|TWO_SIDED|95.0|-9.22|5.27||one-sided p-value|MMRM||Difference (Any remibrutinib - Placebo)|Week 4||5.27|-9.22|0.294
72436649|NCT04035668|144386668|SUPERIORITY||Mean Difference (Final Values)|-0.5||||0.45|TWO_SIDED|95.0|-8.4|7.41||one-sided p-value|MMRM||Difference (Any remibrutinib - Placebo)|Week 8||7.41|-8.40|0.450
72436650|NCT04035668|144386668|SUPERIORITY||Mean Difference (Final Values)|6.02||||0.913|TWO_SIDED|95.0|-2.74|14.78||one-sided p-value|MMRM||Difference (Any remibrutinib - Placebo)|Week 12||14.78|-2.74|0.913
72618764|NCT01026038|144768112|SUPERIORITY_OR_OTHER||Percent Difference|0.0|||||TWO_SIDED|95.0|-3.6|6.5||||||Serotype 9V: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 13vPnC/13vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/13vPnC/13vPnC along with exact 2-sided 95% CI.||6.5|-3.6|
72436651|NCT04035668|144386668|SUPERIORITY||Mean Difference (Final Values)|2.59||||0.722|TWO_SIDED|95.0|-6.16|11.34||one-sided p-value|MMRM||Difference (Any remibrutinib - Placebo)|Week 16||11.34|-6.16|0.722
72436652|NCT04035668|144386668|SUPERIORITY||Mean Difference (Final Values)|-2.86||||0.241|TWO_SIDED|95.0|-10.96|5.24||one-sided p-value|MMRM|||Week 20|Difference (Any remibrutinib - Placebo)|5.24|-10.96|0.241
72436653|NCT04035668|144386668|SUPERIORITY||Mean Difference (Final Values)|2.95||||0.742|TWO_SIDED|95.0|-6.09|11.99||one-sided p-value|MMRM||Difference (Any remibrutinib - Placebo)|Week 24||11.99|-6.09|0.742
72436654|NCT04035668|144386668|OTHER||Mean Difference (Final Values)|-0.18|||||TWO_SIDED|95.0|-8.28|7.91|||MMRM||Difference (remibrutinib 100 mg qd - remibrutinib 100 mg bid)|Week 2||7.91|-8.28|
72436655|NCT04035668|144386668|OTHER||Mean Difference (Final Values)|-0.65|||||TWO_SIDED|95.0|-8.87|7.58|||MMRM||Difference (remibrutinib 100 mg qd - remibrutinib 100 mg bid)|Week 4||7.58|-8.87|
72436656|NCT04035668|144386668|OTHER||Mean Difference (Final Values)|0.1|||||TWO_SIDED|95.0|-9.28|9.48|||MMRM||Difference (remibrutinib 100 mg qd - remibrutinib 100 mg bid)|Week 8||9.48|-9.28|
72436657|NCT04035668|144386668|OTHER||Mean Difference (Final Values)|-4.4|||||TWO_SIDED|95.0|-14.71|5.9|||MMRM||Difference (remibrutinib 100 mg qd - remibrutinib 100 mg bid)|Week 12||5.90|-14.71|
72436658|NCT04035668|144386668|OTHER||Mean Difference (Final Values)|-12.1|||||TWO_SIDED|95.0|-22.47|-1.77|||MMRM||Difference (remibrutinib 100 mg qd - remibrutinib 100 mg bid)|Week 16||-1.77|-22.47|
72436659|NCT04035668|144386668|OTHER||Mean Difference (Final Values)|-6.25|||||TWO_SIDED|95.0|-16.0|3.5|||MMRM||Difference (remibrutinib 100 mg qd - remibrutinib 100 mg bid)|Week 20||3.50|-16.00|
72436660|NCT04035668|144386668|OTHER||Mean Difference (Final Values)|-8.1|||||TWO_SIDED|95.0|-19.16|2.96|||MMRM||Difference (remibrutinib 100 mg qd - remibrutinib 100 mg bid)|Week 24||2.96|-19.16|
72436661|NCT00516386|144386684|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|543.0|STANDARD_ERROR_OF_MEAN|41.0|<|0.05|||||||Paired t-test|||We used paired t-tests to assess changes in levels of IGF-1 from baseline levels in girls with AN receiving rhIGF-1. Our hypothesis was that rhIGF-1 administration would be associated with a significant increase in IGF-1 levels.||||<0.05
72436662|NCT00516386|144386685|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|39.3|STANDARD_ERROR_OF_MEAN|9.3|<|0.05||95.0|||||Paired t-test|||We used a paired t-test to determine the change in P1NP from baseline to 7-10 days following administration of rhIGF-1||||<0.05
72494713|NCT00523991|144518875|SUPERIORITY_OR_OTHER|||||||0.996||95.0|||||Cochran-Mantel-Haenszel|Site as stratum||tiotropium versus placebo||||0.996
72494714|NCT00523991|144518876|SUPERIORITY_OR_OTHER|||||||0.196||95.0|||||Cochran-Mantel-Haenszel|Site as stratum||tiotropium versus placebo||||0.196
72384430|NCT00191906|144276488|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Overall. There were no adjustments for multiple comparisons - not applicable. All statistical tests were performed using a 0.05 significance level.|Repeated Measures|Repeated measures model including terms for baseline, study arm, treatment sequence, visit, treatment, and treatment-by-study-arm interaction.||Least Squares Mean (LSMean) values were calculated from the measurements taken at baseline and at the end of each 4 week therapy period.||||<0.001
72384431|NCT00191906|144276489|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Overall. There were no adjustments for multiple comparisons - not applicable. All statistical tests were performed using a 0.05 significance level.|Repeated Measures|Repeated measures model including terms for baseline, study arm, treatment sequence, visit, treatment, and treatment-by-study-arm interaction.||Least Squares Mean (LSMean) values were calculated from the measurements taken at baseline and at the end of each 4 week therapy period.||||<0.001
72384432|NCT00191906|144276490|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Overall. There were no adjustments for multiple comparisons - not applicable. All statistical tests were performed using a 0.05 significance level.|Repeated Measures|Repeated measures model including terms for baseline, study arm, treatment sequence, visit, treatment, and treatment-by-study-arm interaction.||Least Squares Mean (LSMean) values were calculated from the measurements taken at baseline and at the end of each 4 week therapy period.||||<0.001
72384433|NCT00191906|144276491|SUPERIORITY_OR_OTHER|||||||0.094||95.0||||P-value for Overall. There were no adjustments for multiple comparisons - not applicable. All statistical tests were performed using a 0.05 significance level.|Repeated Measures|Repeated measures model including terms for study arm, treatment sequence, visit, treatment, and treatment-by-study-arm interaction.||||||0.094
72384434|NCT00191906|144276492|SUPERIORITY_OR_OTHER|||||||0.312||95.0||||P-value for Overall. There were no adjustments for multiple comparisons - not applicable. All statistical tests were performed using a 0.05 significance level.|Repeated Measures|Repeated measures model including terms for baseline, study arm, treatment sequence, visit, treatment, and treatment-by-study-arm interaction||||||0.312
72384435|NCT00191906|144276493|SUPERIORITY_OR_OTHER|||||||0.508||95.0||||There were no adjustments for multiple comparisons - not applicable. All statistical tests were performed using a 0.05 significance level.|ANCOVA|||ANCOVA model with baseline value, study arm as covariates for ADHD-C versus normal controls.||||0.508
72384436|NCT00191906|144276494|SUPERIORITY_OR_OTHER|||||||0.769||95.0||||There were no adjustments for multiple comparisons - not applicable. All statistical tests were performed using a 0.05 significance level.|ANCOVA|||ANCOVA model with baseline value, study arm as covariate for ADHD-C versus normal controls||||0.769
72384437|NCT00191906|144276495|SUPERIORITY_OR_OTHER|||||||0.302||95.0||||There were no adjustments for multiple comparisons - not applicable. All statistical tests were performed using a 0.05 significance level.|ANCOVA|||ANCOVA model with baseline value, study arm as covariates for ADHD-C+RD versus RD controls.||||0.302
72384438|NCT00191906|144276495|SUPERIORITY_OR_OTHER|||||||0.663||95.0||||There were no adjustments for multiple comparisons - not applicable. All statistical tests were performed using a 0.05 significance level.|ANCOVA|||ANCOVA model with baseline value, study arm as covariate for RD versus RD controls.||||0.663
72494715|NCT00523991|144518877|SUPERIORITY_OR_OTHER|||||||0.8||95.0|||||Cochran-Mantel-Haenszel|Site as stratum||tiotropium versus placebo||||0.800
72494716|NCT00523991|144518878|SUPERIORITY_OR_OTHER|||||||0.215||95.0|||||Cochran-Mantel-Haenszel|Site as stratum||tiotropium versus placebo||||0.215
72384439|NCT00191906|144276496|SUPERIORITY_OR_OTHER|||||||0.07||95.0||||There were no adjustments for multiple comparisons - not applicable. All statistical tests were performed using a 0.05 significance level.|ANCOVA|||ANCOVA model with baseline value, study arm as covariate for ADHD-C+RD versus RD controls.||||0.070
72384440|NCT00191906|144276496|SUPERIORITY_OR_OTHER|||||||0.179||95.0||||There were no adjustments for multiple comparisons - not applicable. All statistical tests were performed using a 0.05 significance level.|ANCOVA|||ANCOVA model with baseline value, study arm as covariate for RD versus RD controls.||||0.179
72384441|NCT00333801|144276499|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Chi-squared|||||||<0.001
72384442|NCT00333801|144276500|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||>0.05
72384443|NCT00333801|144276501|SUPERIORITY_OR_OTHER_LEGACY||Cohen's d|0.93|||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<0.001
72384444|NCT03633617|144276510|SUPERIORITY||Difference in proportion|55.3|||<|0.0001|TWO_SIDED|95.0|39.58|71.04|||Cochran-Mantel-Haenszel||Difference is dupilumab minus placebo|||71.04|39.58|<0.0001
72384445|NCT03633617|144276510|SUPERIORITY||Difference in proportion|56.0|||<|0.0001|TWO_SIDED|95.0|43.44|68.54|||Cochran-Mantel-Haenszel||Difference is dupilumab minus placebo|||68.54|43.44|<0.0001
72384446|NCT03633617|144276510|SUPERIORITY||Difference in proportion|53.5|||<|0.0001|TWO_SIDED|95.0|41.2|65.79|||Cochran-Mantel-Haenszel||Difference is dupilumab minus placebo|||65.79|41.20|<0.0001
72384447|NCT03633617|144276511|SUPERIORITY||LS Mean Difference|-12.32||||0.0004|TWO_SIDED|95.0|-19.107|-5.537|||ANCOVA||Dupilumab group vs. Placebo|||-5.537|-19.107|0.0004
72384448|NCT03633617|144276511|SUPERIORITY||LS Mean Difference|-0.51||||0.8393|TWO_SIDED|95.0|-5.423|4.406|||ANCOVA||Dupilumab group vs. Placebo|||4.406|-5.423|0.8393
72384449|NCT03633617|144276511|SUPERIORITY||LS Mean Difference|-9.92|||<|0.0001|TWO_SIDED|95.0|-14.811|-5.022|||ANCOVA||Dupilumab group vs. Placebo|||-5.022|-14.811|<0.0001
72384450|NCT03633617|144276512|SUPERIORITY||LS Mean Difference|-68.26|||<|0.0001|TWO_SIDED|95.0|-86.896|-49.615|||ANCOVA||Dupilumab 300 mg QW vs Placebo|||-49.615|-86.896|<0.0001
72384451|NCT03633617|144276512|SUPERIORITY||LS Mean Difference|-79.22|||<|0.0001|TWO_SIDED|95.0|-103.098|-55.338|||ANCOVA||Dupilumab 300 mg Q2W vs Placebo|||-55.338|-103.098|<0.0001
72384452|NCT03633617|144276512|SUPERIORITY||LS Mean Difference|-88.62|||<|0.0001|TWO_SIDED|95.0|-112.194|-65.046|||ANCOVA||Dupilumab 300 mg QW vs Placebo|||-65.046|-112.194|<0.0001
72384453|NCT03633617|144276513|SUPERIORITY||LS Mean Difference|-37.48||||0.0002|TWO_SIDED|95.0|-57.222|-17.745|||ANCOVA||Dupilumab 300 mg QW vs Placebo|||-17.745|-57.222|0.0002
72384454|NCT03633617|144276513|SUPERIORITY||LS Mean Difference|-4.35||||0.5243|TWO_SIDED|95.0|-17.734|9.038|||ANCOVA||Dupilumab 300 mg Q2W vs Placebo|||9.038|-17.734|0.5243
72494717|NCT00523991|144518879|SUPERIORITY_OR_OTHER|||||||0.205||95.0|||||Cochran-Mantel-Haenszel|Site as stratum||tiotropium versus placebo||||0.205
72494718|NCT00523991|144518880|SUPERIORITY_OR_OTHER|||||||0.622||95.0|||||Cochran-Mantel-Haenszel|Site as stratum||tiotropium versus placebo||||0.622
72618765|NCT01026038|144768112|SUPERIORITY_OR_OTHER||Percent Difference|0.0|||||TWO_SIDED|95.0|-6.7|6.5||||||Serotype 9V: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 7vPnC/7vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/13vPnC/13vPnC along with exact 2-sided 95% CI.||6.5|-6.7|
72384455|NCT03633617|144276513|SUPERIORITY||LS Mean Difference|-22.89||||0.0008|TWO_SIDED|95.0|-36.272|-9.513|||ANCOVA||Dupilumab 300 mg QW vs Placebo|||-9.513|-36.272|0.0008
72384456|NCT03633617|144276514|SUPERIORITY||LS Mean Difference|-0.759|||<|0.0001|TWO_SIDED|95.0|-0.9061|-0.6127|||ANCOVA||Dupilumab 300 mg QW vs Placebo|||-0.6127|-0.9061|<0.0001
72384457|NCT03633617|144276514|SUPERIORITY||LS Mean Difference|-0.666|||<|0.0001|TWO_SIDED|95.0|-0.7773|-0.5538|||ANCOVA||Dupilumab 300 mg Q2W vs Placebo|||-0.5538|-0.7773|<0.0001
72384458|NCT03633617|144276514|SUPERIORITY||LS Mean Difference|-0.682|||<|0.0001|TWO_SIDED|95.0|-0.7929|-0.5707|||ANCOVA||Dupilumab 300 mg QW vs Placebo|||-0.5707|-0.7929|<0.0001
72384459|NCT03633617|144276515|SUPERIORITY||LS Mean Difference|-0.741|||<|0.0001|TWO_SIDED|95.0|-0.8842|-0.5978|||ANCOVA||Dupilumab 300 mg QW vs Placebo|||-0.5978|-0.8842|<0.0001
72436663|NCT03823300|144386692|NON_INFERIORITY|If the lower bound of a two-sided 95.03% confidence interval (CI) for the difference in adjusted means of the two treatments (faricimab minus aflibercept) is greater than -4 letters (the non-inferiority margin), then faricimab is considered non-inferior to aflibercept.|Adjusted mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.91|||TWO_SIDED|95.0|-1.7|1.8|||||The treatment difference in adjusted means of change from baseline BCVA is the calculated difference of Arm A: Faricimab and Arm B: Aflibercept. MMRM adjustments are listed in the outcome measure description.|The null hypothesis, H0: μ(faricimab) - μ(aflibercept) ≤-4 letters; the alternative hypothesis, Ha: μ(faricimab) - μ(aflibercept) \>-4 letters. A sample size of approximately 320 participants in each arm provided greater than 90% power to show non-inferiority of faricimab to aflibercept in the change from baseline BCVA averaged over Weeks 40, 44, and 48 in the ITT population, using a non-inferiority margin of 4 letters at the one-sided 0.02485 significance level.||1.8|-1.7|
72436664|NCT03823300|144386693|OTHER||Adjusted mean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.93|||TWO_SIDED|95.0|-2.4|1.3|||||The treatment difference in adjusted means of change from baseline BCVA is the calculated difference of Arm A: Faricimab and Arm B: Aflibercept. MMRM adjustments are listed in the outcome measure description.|Treatment Difference in Adjusted Means at Weeks 52-60||1.3|-2.4|
72436665|NCT03823300|144386695|OTHER||Difference in CMH Weighted Percentage|-2.0|||||TWO_SIDED|95.0|-8.3|4.3|||||The treatment difference in CMH weighted percentage of participants gaining ≥15 letters is the calculated difference of Arm A: Faricimab and Arm B: Aflibercept.|Gaining ≥15 Letters: Treatment Difference at Weeks 40-48||4.3|-8.3|
72436666|NCT03823300|144386695|OTHER||Difference in CMH Weighted Percentage|3.4|||||TWO_SIDED|95.0|-3.9|10.7|||||The treatment difference in CMH weighted percentage of participants gaining ≥10 letters is the calculated difference of Arm A: Faricimab and Arm B: Aflibercept.|Gaining ≥10 Letters: Treatment Difference at Weeks 40-48||10.7|-3.9|
72436667|NCT03823300|144386695|OTHER||Difference in CMH Weighted Percentage|1.0|||||TWO_SIDED|95.0|-6.6|8.6|||||The treatment difference in CMH weighted percentage of participants gaining ≥5 letters is the calculated difference of Arm A: Faricimab and Arm B: Aflibercept.|Gaining ≥5 Letters: Treatment Difference at Weeks 40-48||8.6|-6.6|
72436668|NCT03823300|144386695|OTHER||Difference in CMH Weighted Percentage|3.1|||||TWO_SIDED|95.0|-3.1|9.3|||||The treatment difference in CMH weighted percentage of participants gaining ≥0 letters is the calculated difference of Arm A: Faricimab and Arm B: Aflibercept.|Gaining ≥0 Letters: Treatment Difference at Weeks 40-48||9.3|-3.1|
72436669|NCT03823300|144386696|OTHER||Difference in CMH Weighted Percentage|-1.2|||||TWO_SIDED|95.0|-7.7|5.3|||||The treatment difference in CMH weighted percentage of participants gaining ≥15 letters is the calculated difference of Arm A: Faricimab and Arm B: Aflibercept.|Treatment Difference in CMH Weighted Percentages at Weeks 52-60||5.3|-7.7|
72436670|NCT03823300|144386701|OTHER||Difference in CMH Weighted Percentage|-1.5|||||TWO_SIDED|95.0|-4.4|1.3|||||The treatment difference in CMH weighted percentage of participants avoiding a loss of ≥15 letters is the calculated difference of Arm A: Faricimab and Arm B: Aflibercept.|Avoiding a Loss of ≥15 Letters: Treatment Difference at Weeks 40-48||1.3|-4.4|
72436671|NCT03823300|144386701|OTHER||Difference in CMH Weighted Percentage|-0.9|||||TWO_SIDED|95.0|-4.5|2.8|||||The treatment difference in CMH weighted percentage of participants avoiding a loss of ≥10 letters is the calculated difference of Arm A: Faricimab and Arm B: Aflibercept.|Avoiding a Loss of ≥10 Letters: Treatment Difference at Weeks 40-48||2.8|-4.5|
72436672|NCT03823300|144386701|OTHER||Difference in CMH Weighted Percentage|2.6|||||TWO_SIDED|95.0|-2.1|7.3|||||The treatment difference in CMH weighted percentage of participants avoiding a loss of ≥5 letters is the calculated difference of Arm A: Faricimab and Arm B: Aflibercept.|Avoiding a Loss of ≥5 Letters: Treatment Difference at Weeks 40-48||7.3|-2.1|
72436673|NCT03823300|144386702|OTHER||Difference in CMH Weighted Percentage|0.4|||||TWO_SIDED|95.0|-2.6|3.3|||||The treatment difference in CMH weighted percentage of participants avoiding a loss of ≥15 letters is the calculated difference of Arm A: Faricimab and Arm B: Aflibercept.|Treatment Difference in CMH Weighted Percentages at Weeks 52-60||3.3|-2.6|
72436674|NCT03823300|144386706|OTHER||Difference in CMH Weighted Percentage|-1.7|||||TWO_SIDED|95.0|-8.5|5.1|||||The treatment difference in CMH weighted percentage of participants gaining ≥15 letters or achieving BCVA ≥84 letters is the calculated difference of Arm A: Faricimab and Arm B: Aflibercept.|Treatment Difference in CMH Weighted Percentages at Weeks 40-48||5.1|-8.5|
72436675|NCT03823300|144386708|OTHER||Difference in CMH Weighted Percentage|5.7|||||TWO_SIDED|95.0|-1.4|12.9|||||The treatment difference in CMH weighted percentage of participants achieving BCVA ≥69 letters is the calculated difference of Arm A: Faricimab and Arm B: Aflibercept.|Treatment Difference in CMH Weighted Percentages at Weeks 40-48||12.9|-1.4|
72436676|NCT03823300|144386710|OTHER||Difference in CMH Weighted Percentage|0.4|||||TWO_SIDED|95.0|-3.6|4.4|||||The treatment difference in CMH weighted percentage of participants with BCVA ≤38 letters is the calculated difference of Arm A: Faricimab and Arm B: Aflibercept.|Treatment Difference in CMH Weighted Percentages at Weeks 40-48||4.4|-3.6|
72436677|NCT03823300|144386718|OTHER||Adjusted mean difference|-6.4|STANDARD_ERROR_OF_MEAN|4.3|||TWO_SIDED|95.0|-14.8|2.1|||||The treatment difference in adjusted means of change from baseline CST is the calculated difference of Arm A: Faricimab and Arm B: Aflibercept. MMRM adjustments are listed in the outcome measure description.|Treatment Difference in Adjusted Means at Weeks 40-48||2.1|-14.8|
72384460|NCT03633617|144276515|SUPERIORITY||LS Mean Difference|-0.661|||<|0.0001|TWO_SIDED|95.0|-0.7674|-0.554|||ANCOVA||Dupilumab 300 mg Q2W vs Placebo|||-0.5540|-0.7674|<0.0001
72384461|NCT03633617|144276515|SUPERIORITY||LS Mean Difference|-0.672|||<|0.0001|TWO_SIDED|95.0|-0.7778|-0.5655|||ANCOVA||Dupilumab 300 mg QW vs Placebo|||-0.5655|-0.7778|<0.0001
72436678|NCT03823300|144386719|OTHER||Adjusted mean difference|1.4|STANDARD_ERROR_OF_MEAN|4.05|||TWO_SIDED|95.0|-6.6|9.3|||||The treatment difference in adjusted means of change from baseline CST is the calculated difference of Arm A: Faricimab and Arm B: Aflibercept. MMRM adjustments are listed in the outcome measure description.|Treatment Difference in Adjusted Means at Weeks 52-60||9.3|-6.6|
72436679|NCT01678196|144386735|SUPERIORITY_OR_OTHER|||||||0.927|TWO_SIDED||||||Chi-squared|||||||0.927
72436680|NCT01678196|144386736|SUPERIORITY_OR_OTHER|||||||0.67|TWO_SIDED||||||ANCOVA|ANCOVA reflects change from Time 1 scores (entered as covariate) to Time 2 Scores.||||||0.67
72436681|NCT01678196|144386737|SUPERIORITY_OR_OTHER|||||||0.743|TWO_SIDED||||||ANCOVA|ANCOVA results include Time 1 scores as a covariate, thus reflecting change over time||||||0.743
72436682|NCT01678196|144386738|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|ANCOVA reflects change for Time 1 values (entered as the covariate) to Time 2 values (entered as the DV)||||||<.001
72436683|NCT03987451|144386756|SUPERIORITY||Odds Ratio (OR)|0.28||||0.0867|TWO_SIDED|95.0|0.06|1.24|||Cochran-Mantel-Haenszel|||The common odds ratio between semaglutide and placebo adjusting for baseline diabetes was estimated along with exact 95% confidence interval based on conditioning on the marginal 2×2 tables.||1.24|0.06|0.0867
72436684|NCT01194154|144386808|SUPERIORITY_OR_OTHER||treatment effect|2.21||||0.657|TWO_SIDED|95.0|-0.35|4.78|||Wilcoxon (Mann-Whitney)||An analysis of covariance (ANCOVA) model with adjustment for baseline eGFR was used to obtain an estimate of the treatment difference.|||4.78|-0.35|0.657
72436685|NCT01194154|144386809|SUPERIORITY_OR_OTHER||treatment effect|2.24||||0.709|TWO_SIDED|95.0|-0.54|5.01|||Wilcoxon (Mann-Whitney)||ANCOVA model with adjustment for baseline eGFR was used to obtain an estimate of the treatment difference.|||5.01|-0.54|0.709
72436686|NCT02026258|144386815|OTHER||Mean Difference (Final Values)|0.52|||<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Based on previous findings, it takes approximately 117 ± 46 days for complete alignment of the mandibular anterior teeth in subjects with severe crowding treated without extractions. For a clinically significant 40% faster alignment in the piezotome-corticision group compared to the control group at an alpha-level (p = 0.05) and desired power of 80%, a sample size of 28 subjects (14 per group) was required. Twenty subjects per group assuming an overall attrition rate of 28%.||||<0.05
72436687|NCT02026258|144386816|OTHER||Mean Difference (Final Values)|0.3|||<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||VAS T0||||<0.05
72436688|NCT02026258|144386816|OTHER||Mean Difference (Final Values)|0.19|||<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||VAS T1||||<0.05
72436689|NCT02026258|144386816|OTHER||Mean Difference (Final Values)|0.19|||<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||VAS T2||||<0.05
72436690|NCT02026258|144386816|OTHER||Mean Difference (Final Values)|0.76|||<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||VAS T3||||<0.05
72436691|NCT02026258|144386817|OTHER||Mean Difference (Final Values)|0.87|||<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Ease of Procedure||||<0.05
72436692|NCT02026258|144386817|OTHER||Mean Difference (Final Values)|0.69|||<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Satisfaction with procedure||||<0.05
72436693|NCT02026258|144386818|OTHER||Fisher chi square|0.71|||<|0.05|TWO_SIDED||||||Fisher Exact|Use of Medications||||||<0.05
72436694|NCT02026258|144386818|OTHER||Fisher chi square|0.99|||<|0.05|TWO_SIDED||||||Fisher Exact|||Undergo procedure again||||<0.05
72618766|NCT01026038|144768112|SUPERIORITY_OR_OTHER||Percent Difference|0.0|||||TWO_SIDED|95.0|-3.7|6.6||||||Serotype 14: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 13vPnC/13vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/7vPnC/13vPnC along with exact 2-sided 95% CI.||6.6|-3.7|
72384462|NCT03633617|144276516|SUPERIORITY||LS Mean Difference|-2.9|||<|0.0001|TWO_SIDED|95.0|-3.91|-1.84|||ANCOVA||Dupilumab 300 mg QW vs Placebo|||-1.84|-3.91|<0.0001
72384463|NCT03633617|144276516|SUPERIORITY||LS Mean Difference|-3.9|||<|0.0001|TWO_SIDED|95.0|-4.86|-3.02|||ANCOVA||Dupilumab 300 mg Q2W vs Placebo|||-3.02|-4.86|<0.0001
72384464|NCT03633617|144276516|SUPERIORITY||LS Mean Difference|-3.8|||<|0.0001|TWO_SIDED|95.0|-4.77|-2.93|||ANCOVA||Dupilumab 300 mg QW vs Placebo|||-2.93|-4.77|<0.0001
72384465|NCT03633617|144276517|SUPERIORITY||Difference in proportion|57.5|||<|0.0001|TWO_SIDED|95.0|41.69|73.33|||Cochran-Mantel-Haenszel||Difference is Dupilumab minus Placebo|||73.33|41.69|<0.0001
72384466|NCT03633617|144276517|SUPERIORITY||Difference in proportion|72.4|||<|0.0001|TWO_SIDED|95.0|61.05|83.7|||Cochran-Mantel-Haenszel||Difference is Dupilumab minus Placebo|||83.70|61.05|<0.0001
72436695|NCT02026258|144386818|OTHER||Fisher chi square|0.49|||<|0.05|TWO_SIDED||||||Fisher Exact|||Recommend procedure to a friend||||<0.05
72436696|NCT02534350|144386819|SUPERIORITY||Treatment Difference|0.1||||0.72|TWO_SIDED|95.0|-0.43|0.63|||ANCOVA|||||0.63|-0.43|0.72
72436697|NCT02534350|144386820|SUPERIORITY||Treatment Difference|-0.12||||0.76|TWO_SIDED|95.0|-0.94|0.69|||ANCOVA|||||0.69|-0.94|0.76
72436698|NCT02534350|144386821|SUPERIORITY||Treatment Difference|0.01||||0.86|TWO_SIDED|95.0|-0.12|0.15|||ANCOVA|||||0.15|-0.12|0.86
72436699|NCT02534350|144386822|SUPERIORITY||Treatment Difference|-3.25||||0.6|TWO_SIDED|95.0|-15.58|9.08|||ANCOVA|||||9.08|-15.58|0.60
72436700|NCT04673851|144386823|OTHER|Single group mean difference between baseline and mid-treatment assessments.|Mean Difference (Net)|-0.86|STANDARD_DEVIATION|5.44|||TWO_SIDED|||||||||Midtreatment - Baseline: 21 participants analyzed (had data at both timepoints)||||
72436701|NCT04673851|144386823|OTHER|Effect size of single group mean difference between baseline and mid-treatment assessments.|Cohen's d|0.16|||||TWO_SIDED|||||||||Midtreatment - Baseline: 21 participants analyzed (had data at both timepoints)||||
72436702|NCT04673851|144386823|OTHER|Single group mean difference between baseline and post-treatment assessments.|Mean Difference (Net)|-2.65|STANDARD_DEVIATION|5.61|||TWO_SIDED|||||||||Posttreatment - Baseline: 20 participants analyzed (had data at both timepoints)||||
72436703|NCT04673851|144386823|OTHER|Effect size of single group mean difference between baseline and post-treatment assessments.|Cohen's d|0.47|||||TWO_SIDED|||||||||Posttreatment - Baseline: 20 participants analyzed (had data at both timepoints)||||
72436704|NCT04673851|144386823|OTHER|Single group mean difference between baseline and mid-treatment assessments.|Mean Difference (Net)|-1.97|STANDARD_DEVIATION|7.19|||TWO_SIDED|||||||||Midtreatment - Baseline: 30 participants analyzed (had data at both timepoints)||||
72558383|NCT00840281|144646338|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model containing factors for sequence of products, subjects within sequence, periods, and products was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|101.0||||||90.0|98.7|103.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||103|98.7|
72384467|NCT03633617|144276517|SUPERIORITY||Difference in proportion|74.9|||<|0.0001|TWO_SIDED|95.0|64.25|85.5|||Cochran-Mantel-Haenszel||Difference is Dupilumab minus Placebo|||85.50|64.25|<0.0001
72384468|NCT03633617|144276518|SUPERIORITY||Hodges-Lehmann estimator|-2.25|||<|0.0001|TWO_SIDED|95.0|-2.72|-1.73|||Wilcoxon rank-sum test||Median Difference is Dupilumab minus Placebo|||-1.7300|-2.7200|<0.0001
72384469|NCT03633617|144276518|SUPERIORITY||Hodges-Lehmann estimator|-1.84|||<|0.0001|TWO_SIDED|95.0|-2.42|-1.11|||Wilcoxon rank-sum test||Median Difference is Dupilumab minus Placebo|||-1.1100|-2.4200|<0.0001
72384470|NCT03633617|144276518|SUPERIORITY||Hodges-Lehmann estimator|-1.85|||<|0.0001|TWO_SIDED|95.0|-2.44|-1.15|||Wilcoxon rank-sum test||Median Difference is Dupilumab minus Placebo|||-1.1500|-2.4400|<0.0001
72384471|NCT03633617|144276519|SUPERIORITY||Hodges-Lehmann estimator|-1.59|||<|0.0001|TWO_SIDED|95.0|-1.74|-1.27|||Wilcoxon rank-sum test||Median Difference is Dupilumab minus Placebo|||-1.2700|-1.7400|<0.0001
72384472|NCT03633617|144276519|SUPERIORITY||Hodges-Lehmann estimator|-1.255|||<|0.0001|TWO_SIDED|95.0|-1.73|-1.05|||Wilcoxon rank-sum test||Median Difference is Dupilumab minus Placebo|||-1.0500|-1.7300|<0.0001
72436705|NCT04673851|144386823|OTHER|Effect size of single group mean difference between baseline and mid-treatment assessments.|Cohen's d|0.27|||||TWO_SIDED|||||||||Midtreatment - Baseline: 30 participants analyzed (had data at both timepoints)||||
72436706|NCT04673851|144386823|OTHER|Single group mean difference between baseline and post-treatment assessments.|Mean Difference (Net)|-4.15|STANDARD_DEVIATION|7.93|||TWO_SIDED|||||||||Posttreatment - Baseline: 27 participants analyzed (had data at both timepoints)||||
72436707|NCT04673851|144386823|OTHER|Effect size of single group mean difference between baseline and post-treatment assessments.|Cohen's d|0.52|||||TWO_SIDED|||||||||Posttreatment - Baseline: 27 participants analyzed (had data at both timepoints)||||
72436708|NCT04673851|144386824|OTHER|Single group mean difference between baseline and mid-treatment assessments.|Mean Difference (Net)|-1.52|STANDARD_DEVIATION|8.95|||TWO_SIDED|||||||||Midtreatment - Baseline: 21 participants analyzed (had data at both timepoints)||||
72436709|NCT04673851|144386824|OTHER|Effect size of single group mean difference between baseline and mid-treatment assessments.|Cohen's d|0.17|||||TWO_SIDED|||||||||Midtreatment - Baseline: 21 participants analyzed (had data at both timepoints)||||
72436710|NCT04673851|144386824|OTHER|Single group mean difference between baseline and post-treatment assessments.|Mean Difference (Net)|1.15|STANDARD_DEVIATION|5.8|||TWO_SIDED|||||||||Posttreatment - Baseline: 20 participants analyzed (had data at both timepoints)||||
72436711|NCT04673851|144386824|OTHER|Effect size of single group mean difference between baseline and post-treatment assessments.|Cohen's d|0.2|||||TWO_SIDED|||||||||Posttreatment - Baseline: 20 participants analyzed (had data at both timepoints)||||
72436712|NCT04673851|144386824|OTHER|Single group mean difference between baseline and mid-treatment assessments.|Mean Difference (Net)|0.67|STANDARD_DEVIATION|10.29|||TWO_SIDED|||||||||Midtreatment - Baseline: 30 participants analyzed (had data at both timepoints)||||
72436713|NCT04673851|144386824|OTHER|Effect size of single group mean difference between baseline and mid-treatment assessments.|Cohen's d|0.07|||||TWO_SIDED|||||||||Midtreatment - Baseline: 30 participants analyzed (had data at both timepoints)||||
72436714|NCT04673851|144386824|OTHER|Single group mean difference between baseline and post-treatment assessments.|Mean Difference (Net)|2.07|STANDARD_DEVIATION|9.47|||TWO_SIDED|||||||||Posttreatment - Baseline: 27 participants analyzed (had data at both timepoints)||||
72436715|NCT04673851|144386824|OTHER|Effect size of single group mean difference between baseline and post-treatment assessments.|Cohen's d|0.22|||||TWO_SIDED|||||||||Posttreatment - Baseline: 27 participants analyzed (had data at both timepoints)||||
72436716|NCT04673851|144386825|OTHER|Single group mean difference between baseline and mid-treatment assessments.|Mean Difference (Net)|-0.05|STANDARD_DEVIATION|7.08|||TWO_SIDED|||||||||Midtreatment - Baseline: 21 participants analyzed (had data at both timepoints)||||
72436717|NCT04673851|144386825|OTHER|Effect size of single group mean difference between baseline and mid-treatment assessments.|Cohen's d|0.01|||||TWO_SIDED|||||||||Midtreatment - Baseline: 21 participants analyzed (had data at both timepoints)||||
72384473|NCT03633617|144276519|SUPERIORITY||Hodges-Lehmann estimator|-1.275|||<|0.0001|TWO_SIDED|95.0|-1.82|-1.07|||Wilcoxon rank-sum test||Median Difference is Dupilumab minus Placebo|||-1.0700|-1.8200|<0.0001
72384474|NCT03633617|144276520|SUPERIORITY||Difference in proportion|21.9||||0.0017|TWO_SIDED|95.0|9.42|34.38|||Cochran-Mantel-Haenszel||Difference is Dupilumab minus Placebo|||34.38|9.42|0.0017
72384475|NCT03633617|144276520|SUPERIORITY||Difference in proportion|27.6|||<|0.0001|TWO_SIDED|95.0|17.2|38.09|||Cochran-Mantel-Haenszel||Difference is Dupilumab minus Placebo|||38.09|17.20|<0.0001
72384476|NCT03633617|144276520|SUPERIORITY||Difference in proportion|28.9|||<|0.0001|TWO_SIDED|95.0|18.36|39.46|||Cochran-Mantel-Haenszel||Difference is Dupilumab minus Placebo|||39.46|18.36|<0.0001
72436718|NCT04673851|144386825|OTHER|Single group mean difference between baseline and post-treatment assessments.|Mean Difference (Net)|-2.35|STANDARD_DEVIATION|7.53|||TWO_SIDED|||||||||Posttreatment - Baseline: 20 participants analyzed (had data at both timepoints)||||
72436719|NCT04673851|144386825|OTHER|Effect size of single group mean difference between baseline and post-treatment assessments.|Cohen's d|0.31|||||TWO_SIDED|||||||||Posttreatment - Baseline: 20 participants analyzed (had data at both timepoints)||||
72436720|NCT04673851|144386825|OTHER|Single group mean difference between baseline and mid-treatment assessments.|Mean Difference (Net)|0.9|STANDARD_DEVIATION|9.95|||TWO_SIDED|||||||||Midtreatment - Baseline: 30 participants analyzed (had data at both timepoints)||||
72436721|NCT04673851|144386825|OTHER|Effect size of single group mean difference between baseline and mid-treatment assessments.|Cohen's d|0.09|||||TWO_SIDED|||||||||Midtreatment - Baseline: 30 participants analyzed (had data at both timepoints)||||
72436722|NCT04673851|144386825|OTHER|Single group mean difference between baseline and post-treatment assessments.|Mean Difference (Net)|-2.56|STANDARD_DEVIATION|9.6|||TWO_SIDED|||||||||Posttreatment - Baseline: 27 participants analyzed (had data at both timepoints)||||
72558384|NCT00957021|144646424|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||KSS Pain/Motion and Function Score comparison from pre-op to 1, 2 and 5 year||||<.0001
72384477|NCT03633617|144276521|SUPERIORITY||LS Mean Difference|-0.368||||0.0077|TWO_SIDED|95.0|-0.6388|-0.0975|||ANCOVA||Dupilumab group vs Placebo|||-0.0975|-0.6388|0.0077
72494719|NCT00523991|144518881|SUPERIORITY_OR_OTHER|||||||0.446||95.0|||||Cochran-Mantel-Haenszel|Site as stratum||tiotropium versus placebo||||0.446
72494720|NCT00523991|144518883|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01||||0.819||95.0|-0.05|0.06||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|terms for treatment, site, and baseline value Mean Difference (Final Values) means difference in LSMeans||tiotropium versus placebo||0.06|-0.05|0.819
72494721|NCT00523991|144518884|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.04||||0.204||95.0|-0.1|0.02||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms for treatment, site, and baseline value~Mean Difference (Final Values) means difference in LSMeans"||tiotropium versus placebo||0.02|-0.10|0.204
72494722|NCT00523991|144518885|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01||||0.67||95.0|-0.08|0.05||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms for treatment, site, and baseline value~Mean Difference (Final Values) means difference in LSMeans"||tiotropium versus placebo||0.05|-0.08|0.670
72494723|NCT00523991|144518886|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02||||0.63||95.0|-0.09|0.06||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|terms for treatment, site, and baseline value Mean Difference (Final Values) means difference in LSMeans||tiotropium versus placebo||0.06|-0.09|0.630
72494724|NCT00523991|144518887|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02||||0.704||95.0|-0.1|0.07||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|terms for treatment, site, and baseline value Mean Difference (Final Values) means difference in LSMeans||tiotropium versus placebo||0.07|-0.10|0.704
72494725|NCT00523991|144518888|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02||||0.579||95.0|-0.11|0.06||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms for treatment, site, and baseline value~Mean Difference (Final Values) means difference in LSMeans"||tiotropium versus placebo||0.06|-0.11|0.579
72494726|NCT00523991|144518890|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-23.54||||0.916||95.0|-464.02|416.94||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms for treatment, site, and baseline value~Mean Difference (Final Values) means difference in LSMeans"||tiotropium versus placebo||416.94|-464.02|0.916
72494727|NCT00523991|144518891|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-31.42||||0.899||95.0|-520.19|457.34||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms for treatment, site, and baseline value~Mean Difference (Final Values) means difference in LSMeans"||tiotropium versus placebo||457.34|-520.19|0.899
72494728|NCT00523991|144518892|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|181.99||||0.495||95.0|-341.75|705.73||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms for treatment, site, and baseline value~Mean Difference (Final Values) means difference in LSMeans"||placebo versus tiotropium||705.73|-341.75|0.495
72494729|NCT00523991|144518893|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|258.83||||0.318||95.0|-250.37|768.03||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms for treatment, site, and baseline value~Mean Difference (Final Values) means difference in LSMeans"||tiotropium versus placebo||768.03|-250.37|0.318
72384478|NCT03633617|144276521|SUPERIORITY||LS Mean Difference|-0.015||||0.8586|TWO_SIDED|95.0|-0.1782|0.1485|||ANCOVA||Dupilumab group vs. Placebo|||0.1485|-0.1782|0.8586
72384479|NCT03633617|144276521|SUPERIORITY||LS Mean Difference|-0.309||||0.0002|TWO_SIDED|95.0|-0.4703|-0.1471|||ANCOVA||Dupilumab group vs. Placebo|||-0.1471|-0.4703|0.0002
72384480|NCT03633617|144276522|SUPERIORITY||LS Mean Difference|-2.0||||0.0467|TWO_SIDED|95.0|-3.87|-0.03|||ANCOVA||Dupilumab group vs. Placebo|||-0.03|-3.87|0.0467
72384481|NCT03633617|144276522|SUPERIORITY||LS Mean Difference|-0.5||||0.5469||95.0|-2.03|1.08|||ANCOVA||Dupilumab group vs. Placebo|||1.08|-2.03|0.5469
72494730|NCT00523991|144518894|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|211.18||||0.45||95.0|-338.04|760.39||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms for treatment, site, and baseline value~Mean Difference (Final Values) means difference in LSMeans"||tiotropium versus placebo||760.39|-338.04|0.450
72494731|NCT00523991|144518895|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|51.46||||0.858||95.0|-512.2|615.12||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms for treatment, site, and baseline value~Mean Difference (Final Values) means difference in LSMeans"||tiotropium versus placebo||615.12|-512.20|0.858
72494732|NCT03439033|144518897|SUPERIORITY||Risk Difference (RD)|0.42|||<|0.0001|TWO_SIDED|95.0|0.3|0.53|||McNemar||Risk difference reflects PSMA PET/MRI Scan detection proportion minus MRI scan detection proportion.|||0.53|0.30|<0.0001
72494733|NCT01064167|144518911|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Chi-squared|||Given that the frequency of RBC transfusion for OPCAB surgery is about 55%, to detect 35% reduction in TA group, with power=o.8 and α=0.05, a group of 107 patients in each arm is required. We estimated a crossover rate of 20%. The final sample size for randomization purposes increased to a total of 260 patients. The Chi-square test was used to test the differences in categorical variables between both groups.If one or more cells had an expected count less than 5, Fisher's Exact Test was used.||||<0.05
72494734|NCT01064167|144518912|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||t-test, 2 sided|||||||<0.05
72558385|NCT00957021|144646425|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||SF-36 Physical score comparison from pre-op to 1, 2, 3, 4 and 5 years||||<.0001
72384482|NCT03633617|144276522|SUPERIORITY||LS Mean Difference|-1.5||||0.0718|TWO_SIDED|95.0|-3.0|0.13|||ANCOVA||Dupilumab group vs. Placebo|||0.13|-3.0|0.0718
72384483|NCT03633617|144276523|SUPERIORITY||LS Mean Difference|-1.7||||0.0051|TWO_SIDED|95.0|-2.93|-0.52|||ANCOVA||Dupilumab group vs. Placebo|||-0.52|-2.93|0.0051
72384484|NCT03633617|144276523|SUPERIORITY||LS Mean Difference|-0.5||||0.3152|TWO_SIDED|95.0|-1.38|0.44|||ANCOVA||Dupilumab group vs. Placebo|||0.44|-1.38|0.3152
72384485|NCT03633617|144276523|SUPERIORITY||LS Mean Difference|-1.4||||0.0037|TWO_SIDED|95.0|-2.3|0.45|||ANCOVA||Dupilumab group vs. Placebo|||0.45|-2.30|0.0037
72384486|NCT03633617|144276524|SUPERIORITY||Difference in proportion|-12.7||||0.017|TWO_SIDED|95.0|-23.21|-2.26|||Cochran-Mantel-Haenszel||Difference is Dupilumab minus Placebo|||-2.26|-23.21|0.0170
72384487|NCT03633617|144276524|SUPERIORITY||Difference in proportion|-1.3||||0.5493|TWO_SIDED|95.0|-5.51|2.93|||Cochran-Mantel-Haenszel||Difference is Dupilumab minus Placebo|||2.93|-5.51|0.5493
72436723|NCT04673851|144386825|OTHER|Effect size of single group mean difference between baseline and post-treatment assessments.|Cohen's d|0.27|||||TWO_SIDED|||||||||Posttreatment - Baseline: 27 participants analyzed (had data at both timepoints)||||
72436724|NCT04673851|144386826|OTHER|Single group mean difference between baseline and mid-treatment assessments.|Mean Difference (Net)|-0.29|STANDARD_DEVIATION|8.27|||TWO_SIDED|||||||||Midtreatment - Baseline: 21 participants analyzed (had data at both timepoints)||||
72436725|NCT04673851|144386826|OTHER|Effect size of single group mean difference between baseline and mid-treatment assessments.|Cohen's d|0.04|||||TWO_SIDED|||||||||Midtreatment - Baseline: 21 participants analyzed (had data at both timepoints)||||
72436726|NCT04673851|144386826|OTHER|Single group mean difference between baseline and post-treatment assessments.|Mean Difference (Net)|2.6|STANDARD_DEVIATION|7.86|||TWO_SIDED|||||||||Posttreatment - Baseline: 20 participants analyzed (had data at both timepoints)||||
72436727|NCT04673851|144386826|OTHER|Effect size of single group mean difference between baseline and post-treatment assessments.|Cohen's d|0.33|||||TWO_SIDED|||||||||Posttreatment - Baseline: 20 participants analyzed (had data at both timepoints)||||
72436728|NCT04673851|144386826|OTHER|Single group mean difference between baseline and mid-treatment assessments.|Mean Difference (Net)|2.17|STANDARD_DEVIATION|7.84|||TWO_SIDED|||||||||Midtreatment - Baseline: 30 participants analyzed (had data at both timepoints)||||
72436729|NCT04673851|144386826|OTHER|Effect size of single group mean difference between baseline and mid-treatment assessments.|Cohen's d|0.28|||||TWO_SIDED|||||||||Midtreatment - Baseline: 30 participants analyzed (had data at both timepoints)||||
72384488|NCT03633617|144276524|SUPERIORITY||Difference in proportion|0.0||||0.9887|TWO_SIDED|95.0|-4.9|5.02|||Cochran-Mantel-Haenszel||Difference is Dupilumab minus Placebo|||5.02|-4.9|0.9887
72384489|NCT01480089|144276562|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.308|STANDARD_ERROR_OF_MEAN|0.777||0.098|TWO_SIDED|95.0|-2.83|0.214|||t-test, 2 sided|||The null hypothesis is that the mean VAS score 2 hours post surgery is equivalent for individuals randomized to Intraperitoneal Ropivacaine(AIR) and those randomized to Atomized Intraperitoneal Saline (AIS).||0.214|-2.830|.098
72436730|NCT04673851|144386826|OTHER|Single group mean difference between baseline and post-treatment assessments.|Mean Difference (Net)|6.48|STANDARD_DEVIATION|8.5|||TWO_SIDED|||||||||Posttreatment - Baseline: 27 participants analyzed (had data at both timepoints)||||
72436731|NCT04673851|144386826|OTHER|Effect size of single group mean difference between baseline and post-treatment assessments.|Cohen's d|0.76|||||TWO_SIDED|||||||||Posttreatment - Baseline: 27 participants analyzed (had data at both timepoints)||||
72436732|NCT04673851|144386827|OTHER|Single group mean difference between mid-treatment and post-treatment assessments.|Mean Difference (Net)|4.11|STANDARD_DEVIATION|6.86|||TWO_SIDED|||||||||Posttreatment - Midtreatment: 19 participants analyzed (had data at both timepoints)||||
72436733|NCT04673851|144386827|OTHER|Effect size of single group mean difference between mid-treatment and post-treatment assessments.|Cohen's d|0.6|||||TWO_SIDED|||||||||Posttreatment - Midtreatment: 19 participants analyzed (had data at both timepoints)||||
72436734|NCT04673851|144386827|OTHER|Single group mean difference between 1.5 month and mid-treatment assessments.|Mean Difference (Net)|0.77|STANDARD_DEVIATION|6.88|||TWO_SIDED|||||||||Midtreatment - 1.5 Months: 30 participants analyzed (had data at both timepoints)||||
72436735|NCT04673851|144386827|OTHER|Effect size of single group mean difference between 1.5 month and mid-treatment assessments.|Cohen's d|0.11|||||TWO_SIDED|||||||||Midtreatment - 1.5 Months: 30 participants analyzed (had data at both timepoints)||||
72436736|NCT04673851|144386827|OTHER|Single group mean difference between 1.5 month and 4.5 month assessments.|Mean Difference (Net)|-0.15|STANDARD_DEVIATION|5.78|||TWO_SIDED|||||||||4.5 Months - 1.5 Months: 27 participants analyzed (had data at both timepoints)||||
72384490|NCT01480089|144276563|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.065|STANDARD_ERROR_OF_MEAN|0.53||0.9|TWO_SIDED|95.0|-1.103|0.973|||t-test, 2 sided|||The null hypothesis is that the mean VAS score 12 hours post surgery is equivalent for individuals randomized to Intraperitoneal Ropivacaine(AIR) and those randomized to Atomized Intraperitoneal Saline (AIS).||0.973|-1.103|.90
72384491|NCT01050543|144276564|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.1|||<|0.0001|TWO_SIDED|95.0|6.8|9.6|||ANOVA|||To evaluate the efficacy of sugammadex compared to the efficacy of neostigmine, the ratio of the geometric means of time to recovery of the T4/T1 ratio to 0.9 was calculated using a 2-way ANOVA model adjusted for trial site.||9.6|6.8|<0.0001
72436737|NCT04673851|144386827|OTHER|Effect size of single group mean difference between 1.5 month and 4.5 month assessments.|Cohen's d|0.03|||||TWO_SIDED|||||||||4.5 Months - 1.5 Months: 27 participants analyzed (had data at both timepoints)||||
72436738|NCT04673851|144386827|OTHER|Single group mean difference between 1.5 month and post-treatment assessments.|Mean Difference (Net)|-2.63|STANDARD_DEVIATION|7.95|||TWO_SIDED|||||||||Posttreatment - 1.5 Months: 27 participants analyzed (had data at both timepoints)||||
72436739|NCT04673851|144386827|OTHER|Effect size of single group mean difference between 1.5 month and post-treatment assessments.|Cohen's d|0.33|||||TWO_SIDED|||||||||Posttreatment - 1.5 Months: 27 participants analyzed (had data at both timepoints)||||
72436740|NCT04673851|144386828|OTHER|Single group mean difference between mid-treatment and post-treatment assessments.|Mean Difference (Net)|1.68|STANDARD_DEVIATION|3.76|||TWO_SIDED|||||||||Posttreatment - Midtreatment: 19 participants analyzed (had data at both timepoints)||||
72436741|NCT04673851|144386828|OTHER|Effect size of single group mean difference between mid-treatment and post-treatment assessments.|Cohen's d|0.45|||||TWO_SIDED|||||||||Posttreatment - Midtreatment: 19 participants analyzed (had data at both timepoints)||||
72494735|NCT00725075|144518913|SUPERIORITY_OR_OTHER||Mean Change From Baseline|-2.26||||0.267|TWO_SIDED|95.0|-6.25|1.74|||ANCOVA|ANCOVA model with the baseline value as covariate and with treatment group and center as fixed factors||Comparison of Mean Change in Baseline: Least Squared Estimates with Statistical Inference.||1.74|-6.25|0.267
72494736|NCT00725075|144518913|SUPERIORITY_OR_OTHER||Mean Change From Baseline|-0.08||||0.966|TWO_SIDED|95.0|-3.91|3.74|||ANCOVA|ANCOVA model with the baseline value as covariate and with treatment group and center as fixed factors||Comparison of Mean Change in Baseline: Least Squared Estimates with Statistical Inference.||3.74|-3.91|0.966
72494737|NCT02340663|144518941|OTHER|||||||0.23|||||||t-test, 2 sided|||||||0.23
72494738|NCT02340663|144518942|OTHER|||||||0.045|||||||ANOVA|||||||0.045
72384492|NCT00570765|144276565|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|Treatment arms compared using 2-sided Wilcoxon-Mann-Whitney test at 5% significance level. Treatment groups were pairwise compared versus placebo.||Hierarchical testing strategy was proposed to account for multiple comparisons. Statistical significance was evaluated as follows: if statistical significance at alpha=0.05 is shown for the 10 mg OCA versus placebo, then the statistical significance at alpha=0.05 for the 50 mg OCA versus placebo was evaluated. If no statistical significance was shown at alpha=0.05 at the first step, then the subsequent comparison was not considered statistically significant.||||<0.0001
72384493|NCT00570765|144276566|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|Treatment arms compared using 2-sided Wilcoxon-Mann-Whitney test at 5% significance level. Treatment groups were pairwise compared versus placebo.||||||<0.0001
72384494|NCT00570765|144276567|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.01||95.0|||||Wilcoxon (Mann-Whitney)|Tx arms will be compared using the 2-sided Wilcoxon-Mann-Whitney test, at 5% significance level. Tx groups will be pairwise compared vs. placebo.||||||<0.01
72436742|NCT04673851|144386828|OTHER|Single group mean difference between 1.5 month and mid-treatment assessments.|Mean Difference (Net)|-0.07|STANDARD_DEVIATION|2.73|||TWO_SIDED|||||||||Midtreatment - 1.5 Months: 30 participants analyzed (had data at both timepoints)||||
72436743|NCT04673851|144386828|OTHER|Effect size of single group mean difference between 1.5 month and mid-treatment assessments.|Cohen's d|0.02|||||TWO_SIDED|||||||||Midtreatment - 1.5 Months: 30 participants analyzed (had data at both timepoints)||||
72436744|NCT04673851|144386828|OTHER|Single group mean difference between 1.5 month and 4.5 month assessments.|Mean Difference (Net)|-0.56|STANDARD_DEVIATION|2.44|||TWO_SIDED|||||||||4.5 Months - 1.5 Months: 27 participants analyzed (had data at both timepoints)||||
72436745|NCT04673851|144386828|OTHER|Effect size of single group mean difference between 1.5 month and 4.5 month assessments.|Cohen's d|0.23|||||TWO_SIDED|||||||||4.5 Months - 1.5 Months: 27 participants analyzed (had data at both timepoints)||||
72436746|NCT04673851|144386828|OTHER|Single group mean difference between 1.5 month and post-treatment assessments.|Mean Difference (Net)|-0.59|STANDARD_DEVIATION|3.15|||TWO_SIDED|||||||||Posttreatment - 1.5 Months: 27 participants analyzed (had data at both timepoints)||||
72436747|NCT04673851|144386828|OTHER|Effect size of single group mean difference between 1.5 month and post-treatment assessments.|Cohen's d|0.19|||||TWO_SIDED|||||||||Posttreatment - 1.5 Months: 27 participants analyzed (had data at both timepoints)||||
72436748|NCT04673851|144386829|OTHER|Single group mean difference between mid-treatment and post-treatment assessments.|Mean Difference (Net)|2.42|STANDARD_DEVIATION|4.48|||TWO_SIDED|||||||||Posttreatment - Midtreatment: 19 participants analyzed (had data at both timepoints)||||
72436749|NCT04673851|144386829|OTHER|Effect size of single group mean difference between mid-treatment and post-treatment assessments.|Cohen's d|0.54|||||TWO_SIDED|||||||||Posttreatment - Midtreatment: 19 participants analyzed (had data at both timepoints)||||
72436750|NCT04673851|144386829|OTHER|Single group mean difference between 1.5 month and mid-treatment assessments.|Mean Difference (Net)|0.83|STANDARD_DEVIATION|5.05|||TWO_SIDED|||||||||Midtreatment - 1.5 Months: 30 participants analyzed (had data at both timepoints)||||
72436751|NCT04673851|144386829|OTHER|Effect size of single group mean difference between 1.5 month and mid-treatment assessments.|Cohen's d|0.17|||||TWO_SIDED|||||||||Midtreatment - 1.5 Months: 30 participants analyzed (had data at both timepoints)||||
72436752|NCT04673851|144386829|OTHER|Single group mean difference between 1.5 month and 4.5 month assessments.|Mean Difference (Net)|0.41|STANDARD_DEVIATION|4.55|||TWO_SIDED|||||||||4.5 Months - 1.5 Months: 27 participants analyzed (had data at both timepoints)||||
72436753|NCT04673851|144386829|OTHER|Effect size of single group mean difference between 1.5 month and 4.5 month assessments.|Cohen's d|0.09|||||TWO_SIDED|||||||||4.5 Months - 1.5 Months: 27 participants analyzed (had data at both timepoints)||||
72436754|NCT04673851|144386829|OTHER|Single group mean difference between 1.5 month and post-treatment assessments.|Mean Difference (Net)|-2.04|STANDARD_DEVIATION|6.12|||TWO_SIDED|||||||||Posttreatment - 1.5 Months: 27 participants analyzed (had data at both timepoints)||||
72436755|NCT04673851|144386829|OTHER|Effect size of single group mean difference between 1.5 month and post-treatment assessments.|Cohen's d|0.33|||||TWO_SIDED|||||||||Posttreatment - 1.5 Months: 27 participants analyzed (had data at both timepoints)||||
72436756|NCT02954848|144386855|SUPERIORITY||Median Difference (Final Values)|3.8||||0.0643|TWO_SIDED|95.0|0.0|10.6|||Wilcoxon Rank-Sum Test||The point estimate of the median difference between the treatment groups was calculated using the Hodges-Lehmann estimation.|||10.600|0.000|0.0643
72436757|NCT02954848|144386856|SUPERIORITY|||||||0.0003|||||||Log Rank|||||||0.0003
72436758|NCT02954848|144386857|SUPERIORITY||Median Difference (Final Values)|-0.11||||0.0826|TWO_SIDED|95.0|-0.24|0.01|||Wilcoxon Rank-Sum Test|||||0.0100|-0.2400|0.0826
72436759|NCT02954848|144386858|SUPERIORITY||Median Difference (Final Values)|3.3||||0.0478|TWO_SIDED|95.0|0.0|5.3|||Wilcoxon Rank-Sum Test|||Statistical analysis for criteria 1, improved response||5.300|0.000|0.0478
72436760|NCT02954848|144386858|SUPERIORITY||Median Difference (Final Values)|0.0||||0.8963|TWO_SIDED|95.0|-6.1|6.0|||Wilcoxon Rank-Sum Test|||Statistical analysis for criteria 1, not improved response||6.000|-6.100|0.8963
72436761|NCT02954848|144386858|SUPERIORITY||Median Difference (Final Values)|5.2||||0.012|TWO_SIDED|95.0|0.0|10.7|||Wilcoxon Rank-Sum Test|||Statistical analysis for criteria 2, improved response||10.700|0.000|0.0120
72494739|NCT02340663|144518943|OTHER|||||||0.665|||||||t-test, 2 sided|||||||0.665
72494740|NCT02340663|144518944|OTHER|||||||0.249|||||||Wilcoxon (Mann-Whitney)|||||||0.249
72494741|NCT02340663|144518945|OTHER|||||||0.626|||||||Wilcoxon (Mann-Whitney)|||||||0.626
72494742|NCT02340663|144518946|OTHER|||||||0.695|||||||t-test, 2 sided|||||||0.695
72494743|NCT02340663|144518947|OTHER|||||||0.255|||||||Wilcoxon (Mann-Whitney)|||||||0.255
72384495|NCT03711266|144276580|OTHER||Mean Difference (Final Values)|31.4|||<|0.001|TWO_SIDED|95.0|18.5|44.3|||t-test, 2 sided|||Thirty patients were included in the final analysis. The analysis strategy was intent-to-treat, and multiple imputation was used to impute missing follow-up data. We included auxiliary variables that were correlated with the missing variables at r \> 0.4 (Enders, 2010).||44.3|18.5|<.001
72384496|NCT02083081|144276616|SUPERIORITY|||||||0.38|||||||generalized estimating equations (GEE)|||||||0.38
72384497|NCT02083081|144276617|SUPERIORITY|||||||0.45|||||||generalized estimating equations (GEE)|||||||0.45
72384498|NCT02083081|144276618|SUPERIORITY|||||||0.96|||||||generalized estimating equations (GEE)|||||||0.96
72384499|NCT01104155|144276688|SUPERIORITY_OR_OTHER_LEGACY|||||||0.204|||||||1-sided exact binomial|Based on a one-sided exact binomial test compared to 9%.||||||0.204
72384500|NCT01104155|144276688|SUPERIORITY_OR_OTHER_LEGACY|||||||0.041|||||||1-sided exact binomial|||||||0.041
72384501|NCT01484132|144276695|SUPERIORITY_OR_OTHER|||||||0.58|TWO_SIDED||||||t-test, 2 sided|||One sample t-test was used to test whether the mean change from baseline to 6 months was different from 0.||||0.58
72384502|NCT01484132|144276695|SUPERIORITY_OR_OTHER||Slope|-0.061||||0.406|TWO_SIDED|95.0|-0.206|0.084||P-value is to test the association between composite exposure on all surfaces and change in BPA from baseline to 6 months after adjusting for covariates.|Regression, Linear|Composite exposure on all surfaces was used as the main predictor and baseline BPA, season, household income, and canned food were used as covariates.||To see the association between composite exposure on all surfaces and change in BPA from baseline to 6 months, the linear model was used with the change in BPA outcome. Log-transformed BPA was used for the analysis. Composite exposure on all surfaces was used as the main predictor.||0.084|-0.206|0.406
72384503|NCT01484132|144276695|SUPERIORITY_OR_OTHER||Slope|-0.017||||0.693|TWO_SIDED|95.0|-0.101|0.067||P-value is to test the longitudinal association between composite exposure on all surfaces and change in BPA after adjusting for covariates.|Mixed Models Analysis|Composite exposure on all surfaces was used as the main predictor and baseline BPA, season, household income, and canned food were used as covariates.||To see the longitudinal association between composite exposure on all surfaces and change in BPA from baseline, the repeated measure model was used with all available follow-up BPA data. Log-transformed BPA was used for the analysis. Composite exposure on all surfaces was used as the main predictor.||0.067|-0.101|0.693
72384504|NCT01484132|144276695|SUPERIORITY_OR_OTHER||Slope|-0.123||||0.16|TWO_SIDED|95.0|-0.296|0.05||P-value is to test the association between composite exposure on posterior occlusal surfaces and change in BPA from baseline to 6 months after adjusting for covariates.|Regression, Linear|Baseline BPA, season, household income, and canned food were used as covariates.||To see the association between composite exposure on posterior occlusal surfaces and change in BPA from baseline to 6 months, the linear model was used with the change in BPA outcome. Log-transformed BPA was used for the analysis. Composite exposure on posterior occlusal surfaces was used as the main predictor.||0.050|-0.296|0.160
72384505|NCT01484132|144276695|SUPERIORITY_OR_OTHER||Slope|-0.029||||0.574|TWO_SIDED|95.0|-0.131|0.073||P-value is to test the longitudinal association between composite exposure on posterior occlusal surfaces and change in BPA after adjusting for covariates.|Mixed Models Analysis|Baseline BPA, season, household income, and canned food were used as covariates.||To see the longitudinal association between composite exposure on posterior occlusal surfaces and change in BPA from baseline, the repeated measure model was used with all available follow-up BPA data. Log-transformed BPA was used for the analysis. Composite exposure on posterior occlusal surfaces was used as the main predictor.||0.073|-0.131|0.574
72384506|NCT01484132|144276696|SUPERIORITY_OR_OTHER|||||||0.11|TWO_SIDED||||||t-test, 2 sided|||One sample t-test was used to test whether the mean change from baseline was different from 0.||||0.11
72384507|NCT01484132|144276696|SUPERIORITY_OR_OTHER||Slope|0.299||||0.003|TWO_SIDED|95.0|0.105|0.494||P-value is to test the association between composite exposure on all surfaces and change in BPA from baseline to 1 day after the first treatment after adjusting for covariates.|Regression, Linear|Composite exposure on all surfaces was used as the main predictor and baseline BPA, season, household income, and canned food were used as covariates.||To see the association between composite exposure on all surfaces and change in BPA from baseline to 1 day after the first treatment, the linear model was used with the change in BPA outcome. Log-transformed BPA was used for the analysis. Composite exposure on all surfaces was used as the main predictor.||0.494|0.105|0.003
72384508|NCT01484132|144276696|SUPERIORITY_OR_OTHER||Slope|0.365||||0.002|TWO_SIDED|95.0|0.145|0.585||P-value is to test the association between composite exposure on posterior occlusal surfaces and change in BPA from baseline to 1 day after the first treatment after adjusting for covariates.|Regression, Linear|Baseline BPA, season, household income, and canned food were used as covariates.||To see the association between composite exposure on posterior occlusal surfaces and change in BPA from baseline to 1 day after the first treatment, the linear model was used with the change in BPA outcome. Log-transformed BPA was used for the analysis. Composite exposure on posterior occlusal surfaces was used as the main predictor.||0.585|0.145|0.002
72384509|NCT01484132|144276697|SUPERIORITY_OR_OTHER|||||||0.27|TWO_SIDED||||||t-test, 2 sided|||One sample t-test was used to test whether the mean change from baseline was different from 0.||||0.27
72436762|NCT02954848|144386858|SUPERIORITY||Median Difference (Final Values)|-4.7||||0.0871|TWO_SIDED|95.0|-17.4|0.0|||Wilcoxon Rank-Sum Test|||Statistical analysis for criteria 2, not improved response||0.000|-17.400|0.0871
72494744|NCT02340663|144518948|OTHER|||||||0.049|||||||Wilcoxon (Mann-Whitney)|||||||.049
72494745|NCT02340663|144518951|OTHER|||||||0.75|||||||Wilcoxon (Mann-Whitney)|||||||0.750
72494746|NCT02340663|144518952|OTHER||||||<|0.01||||||The P-value given is the computed value|Mixed Models Analysis|||||||<0.01
72494747|NCT02340663|144518953|OTHER|||||||0.544|||||||Wilcoxon (Mann-Whitney)|||||||0.544
72494748|NCT02340663|144518954|OTHER|||||||0.22|||||||Wilcoxon (Mann-Whitney)|||||||0.220
72436763|NCT02954848|144386859|SUPERIORITY|||||||0.0025|||||||Log Rank|||||||0.0025
72436764|NCT02954848|144386860|SUPERIORITY|||||||0.1059|||||||Log Rank|||||||0.1059
72436765|NCT02954848|144386861|SUPERIORITY|||||||0.0004|||||||Log Rank|||||||0.0004
72436766|NCT02954848|144386862|SUPERIORITY|||||||0.5393|||||||Log Rank|||||||0.5393
72436767|NCT02954848|144386863|SUPERIORITY||Median Difference (Final Values)|-0.1||||0.0505|TWO_SIDED|95.0|-0.21|0.0|||Wilcoxon Rank-Sum Test|||Statistical analysis for criteria 1, improved response||0.0000|-0.2100|0.0505
72494749|NCT02340663|144518955|OTHER|||||||0.081|||||||Wilcoxon (Mann-Whitney)|||||||0.081
72494750|NCT02340663|144518956|OTHER|||||||1|||||||Wilcoxon (Mann-Whitney)|||||||1.0
72384510|NCT01484132|144276697|SUPERIORITY_OR_OTHER||Slope|-0.068||||0.48|TWO_SIDED|95.0|-0.258|0.123||P-value is to test the association between composite exposure on all surfaces and change in BPA from baseline to 14 days after the first treatment after adjusting for covariates.|Regression, Linear|Baseline BPA, season, household income, and canned food were used as covariates.||To see the association between composite exposure on all surfaces and change in BPA from baseline to 14 days after the first treatment, the linear model was used with the change in BPA outcome. Log-transformed BPA was used for the analysis. Composite exposure on all surfaces was used as the main predictor.||0.123|-0.258|0.480
72384511|NCT01484132|144276697|SUPERIORITY_OR_OTHER||Slope|-0.074||||0.501|TWO_SIDED|95.0|-0.293|0.145||P-value is to test the association between composite exposure on posterior occlusal surfaces and change in BPA from baseline to 14 days after the first treatment after adjusting for covariates.|Regression, Linear|Baseline BPA, season, household income, and canned food were used as covariates.||To see the association between composite exposure on posterior occlusal surfaces and change in BPA from baseline to 14 days after the first treatment, the linear model was used with the change in BPA outcome. Log-transformed BPA was used for the analysis. Composite exposure on posterior occlusal surfaces was used as the main predictor.||0.145|-0.293|0.501
72384512|NCT01484132|144276698|SUPERIORITY_OR_OTHER|||||||0.41|TWO_SIDED||||||t-test, 2 sided|||One sample t-test was used to test whether the mean change from baseline was different from 0.||||0.41
72384513|NCT01484132|144276698|SUPERIORITY_OR_OTHER||Slope|-0.082||||0.612|TWO_SIDED|95.0|-0.418|0.254||P-value is to test the association between composite exposure on all surfaces and change in BPA from baseline to 1 day after the second treatment after adjusting for covariates.|Regression, Linear|Composite exposure on all surfaces was used as the main predictor and baseline BPA, season, household income, and canned food were used as covariates.||To see the association between composite exposure on all surfaces and change in BPA from baseline to 1 day after the second treatment, the linear model was used with the change in BPA outcome. Log-transformed BPA was used for the analysis. Composite exposure on all surfaces was used as the main predictor.||0.254|-0.418|0.612
72384514|NCT01484132|144276698|SUPERIORITY_OR_OTHER||Slope|0.078||||0.696|TWO_SIDED|95.0|-0.339|0.495||P-value is to test the association between composite exposure on posterior occlusal surfaces and change in BPA from baseline to 1 day after the second treatment after adjusting for covariates.|Regression, Linear|Baseline BPA, season, household income, and canned food were used as covariates.||To see the association between composite exposure on posterior occlusal surfaces and change in BPA from baseline to 1 day after the second treatment, the linear model was used with the change in BPA outcome. Log-transformed BPA was used for the analysis. Composite exposure on posterior occlusal surfaces was used as the main predictor.||0.495|-0.339|0.696
72384515|NCT01484132|144276699|SUPERIORITY_OR_OTHER|||||||0.76|TWO_SIDED||||||t-test, 2 sided|||One sample t-test was used to test whether the mean change from baseline was different from 0.||||0.76
72384516|NCT01484132|144276699|SUPERIORITY_OR_OTHER||Slope|-0.018||||0.968|TWO_SIDED|95.0|-1.061|1.025||P-value is to test the association between composite exposure on all surfaces and change in BPA from baseline to 14 days after the second treatment after adjusting for covariates.|Regression, Linear|Composite exposure on all surfaces was used as the main predictor and baseline BPA, season, household income, and canned food were used as covariates.||To see the association between composite exposure on all surfaces and change in BPA from baseline to 14 days after the second treatment, the linear model was used with the change in BPA outcome. Log-transformed BPA was used for the analysis. Composite exposure on all surfaces was used as the main predictor.||1.025|-1.061|0.968
72384517|NCT01484132|144276699|SUPERIORITY_OR_OTHER||Slope|-0.083||||0.822|TWO_SIDED|95.0|-0.941|0.775||P-value is to test the association between composite exposure on posterior occlusal surfaces and change in BPA from baseline to 14 days after the second treatment after adjusting for covariates.|Regression, Linear|Baseline BPA, season, household income, and canned food were used as covariates.||To see the association between composite exposure on posterior occlusal surfaces and change in BPA from baseline to 14 days after the second treatment, the linear model was used with the change in BPA outcome. Log-transformed BPA was used for the analysis. Composite exposure on posterior occlusal surfaces was used as the main predictor.||0.775|-0.941|0.822
72384518|NCT01460368|144276724|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.63|||||TWO_SIDED|90.0|-1.38|2.63|||||Treatment comparison at 2 hours.|||2.63|-1.38|
72384519|NCT01460368|144276724|SUPERIORITY_OR_OTHER||Least Squares Means Difference|3.69|||||TWO_SIDED|90.0|1.67|5.71|||||Treatment comparison at 4 hours.|||5.71|1.67|
72384520|NCT01460368|144276724|SUPERIORITY_OR_OTHER||Least Squares Means Difference|9.14|||||TWO_SIDED|90.0|7.12|11.16|||||Treatment comparison at 6 hours.|||11.16|7.12|
72384521|NCT01460368|144276724|SUPERIORITY_OR_OTHER||Least Squares Means Difference|9.08|||||TWO_SIDED|90.0|7.1|11.07|||||Treatment comparison at 8 hours.|||11.07|7.10|
72384522|NCT01460368|144276724|SUPERIORITY_OR_OTHER||Least Squares Means Difference|-0.15|||||TWO_SIDED|90.0|-2.14|1.85|||||Treatment comparison at 12 hours.|||1.85|-2.14|
72384523|NCT01460368|144276724|SUPERIORITY_OR_OTHER||Least Squares Means Difference|3.63|||||TWO_SIDED|90.0|1.63|5.63|||||Treatment comparison at 24 hours.|||5.63|1.63|
72384524|NCT01460368|144276725|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|8.07|||||TWO_SIDED|90.0|5.21|10.94|||||Treatment comparison at 2 hours.|||10.94|5.21|
72384525|NCT01460368|144276725|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|10.56|||||TWO_SIDED|90.0|7.69|13.43|||||Treatment comparison at 4 hours.|||13.43|7.69|
72384526|NCT05055453|144276728|OTHER|A Shapiro Wilks test was used to test for normal distribution of the data.|||||<|0.001||||||"Result for comparison between automatic only and preferred app settings."|Durbin-Conover Pairwise Comparison|||||||<0.001
72384527|NCT05055453|144276728|OTHER||||||<|0.001||||||"Result of comparison between preferred app setting and extreme app setting"|Durbin-Conover Pairwise Comparison|||A Shapiro Wilks test was used to test for normal distribution of the data.||||< 0.001
72384528|NCT05055453|144276728|OTHER|"Result of comparison between automatic only and extreme app setting."||||||0.002|||||||Durbin-Conover Pairwise Comparison|||A Shapiro Wilks test was used to test for normal distribution of the data.||||0.002
72384529|NCT05055453|144276729|OTHER|Analysis of first home trial|||||<|0.001|||||||t-test, 2 sided|||||||<0.001
72384530|NCT05055453|144276729|OTHER||||||<|0.001|||||||t-test, 2 sided|||Analysis of second home trial||||<.001
72494751|NCT02340663|144518957|OTHER|||||||0.731|||||||Wilcoxon (Mann-Whitney)|||||||0.731
72494752|NCT02340663|144518958|OTHER|||||||0.238|||||||Wilcoxon (Mann-Whitney)|||||||0.238
72558386|NCT00957021|144646425|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||SF-36 Mental score comparison from pre-op to 1 year||||<.0001
72494753|NCT02340663|144518959|OTHER|||||||0.952||||||"The P-value refers to the difference in group means, see Group Means row in the table."|ANOVA|||||||0.952
72494754|NCT02340663|144518960|OTHER|||||||0.53||||||"The P-value refers to the difference in group means, see Group Means row in the table."|ANOVA|||||||0.53
72494755|NCT02340663|144518961|OTHER|||||||0.292||||||"The P-value refers to the difference in group means, see Group Means row in the table."|Mixed Models Analysis|||||||0.292
72494756|NCT02340663|144518962|OTHER|||||||0.289|||||||Wilcoxon (Mann-Whitney)|||The P-value refers to the main effect of treatment group, i.e., differences between SOVA bite splints and Michigan bite splints.||||0.289
72558387|NCT00957021|144646425|SUPERIORITY_OR_OTHER|||||||0.0017|||||||t-test, 2 sided|||SF-36 Mental score comparison from pre-op to 2 year||||0.0017
72558388|NCT00957021|144646425|SUPERIORITY_OR_OTHER|||||||0.0055|||||||t-test, 2 sided|||SF-36 Mental score comparison from pre-op to 3 year||||0.0055
72384531|NCT01224665|144276730|SUPERIORITY||Hazard Ratio (HR)|1.1||||0.45|TWO_SIDED|95.0|0.86|1.4||Using an intention-to-treat analysis, we specified a stratified log-rank test with a one-sided alpha of 0.025.|Log Rank|Adjustments were made for the following stratification factors: neoadjuvant chemotherapy, clinical T stage, and Zubrod performance score.|Adjustments were made for the following stratification factors: neoadjuvant chemotherapy, clinical T stage, and Zubrod performance score.|3-year DFS estimates of 55% among participants undergoing SLND and 65% undergoing ELND were used to estimate the target HR. Assuming exponential DFS distribution, 5 years of enrollment, 3 years of follow-up, and 564 eligible participants, the trial would have 85% power to detect a 28% lower risk of recurrence or death with ELND than SLND.||1.40|0.86|0.45
72384532|NCT01224665|144276731|SUPERIORITY||Hazard Ratio (HR)|1.13|||||TWO_SIDED|95.0|0.88|1.45|||||Adjustments were made for the following stratification factors: neoadjuvant chemotherapy, clinical T stage, and Zubrod performance score.|We assumed that the standard lymphadenectomy arm has 5-year survival of 55%, so we had 83% statistical power to detect a hazard ratio of 0.72 (55% vs. 65% survival at 5 years).||1.45|0.88|
72384533|NCT01898208|144276763|SUPERIORITY_OR_OTHER|||||||0.92|TWO_SIDED||||||Kruskal-Wallis|||For Vancomycin, all patients||||0.92
72384534|NCT01898208|144276763|SUPERIORITY_OR_OTHER|||||||0.032|TWO_SIDED||||||Kruskal-Wallis|||For vancomycin, organisms not requiring vancomycin.||||0.032
72384535|NCT01898208|144276763|SUPERIORITY_OR_OTHER|||||||0.037|TWO_SIDED||||||Kruskal-Wallis|||For vancomycin-susceptible enterococci||||0.037
72384536|NCT01898208|144276763|SUPERIORITY_OR_OTHER|||||||0.2|TWO_SIDED||||||Kruskal-Wallis|||For vancomycin, methicillin-susceptible Staphylococcus aureus.||||0.2
72384537|NCT01898208|144276763|SUPERIORITY_OR_OTHER|||||||0.035|TWO_SIDED||||||Kruskal-Wallis|||For nafcillin, oxacillin, or cefazolin.||||0.035
72384538|NCT01898208|144276763|SUPERIORITY_OR_OTHER|||||||0.012|TWO_SIDED||||||Kruskal-Wallis|||For piperacillin-tazobactam.||||0.012
72384539|NCT01898208|144276763|SUPERIORITY_OR_OTHER|||||||0.56|TWO_SIDED||||||Kruskal-Wallis|||For cefepime.||||0.56
72384540|NCT01898208|144276764|SUPERIORITY_OR_OTHER|||||||0.55|TWO_SIDED||||||Kruskal-Wallis|||This analysis compares the 3 groups.||||0.55
72384541|NCT01898208|144276765|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Kruskal-Wallis|||For time to first appropriate de-escalation comparing the 3 groups.||||<0.0001
72384542|NCT01898208|144276765|SUPERIORITY_OR_OTHER|||||||0.04|TWO_SIDED||||||Kruskal-Wallis|||For time to first appropriate escalation comparing the 3 groups.||||0.04
72384543|NCT01898208|144276766|SUPERIORITY_OR_OTHER|||||||0.015|TWO_SIDED||||||Chi-squared|||This analysis compares the 3 groups.||||0.015
72384544|NCT01898208|144276767|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Kruskal-Wallis|||This analysis compares the FilmArray test to control arm.||||<0.0001
72384545|NCT01898208|144276767|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Kruskal-Wallis|||This analysis compares FilmArray plus antimicrobial stewardship to the control arm.||||<0.0001
72384546|NCT01898208|144276768|SUPERIORITY_OR_OTHER|||||||0.79|TWO_SIDED||||||Kruskal-Wallis|||This analysis is to compare the three groups.||||0.79
72384547|NCT01898208|144276769|SUPERIORITY_OR_OTHER|||||||0.9|TWO_SIDED||||||Kruskal-Wallis|||||||0.90
72384548|NCT01898208|144276770|SUPERIORITY_OR_OTHER|||||||0.62|TWO_SIDED||||||Chi-squared|||This analysis is a comparison of the 3 groups.||||0.62
72384549|NCT01898208|144276771|SUPERIORITY_OR_OTHER|||||||0.6|TWO_SIDED||||||Kruskal-Wallis|||This analysis compares the three groups.||||0.60
72384550|NCT01898208|144276772|SUPERIORITY_OR_OTHER|||||||0.74|TWO_SIDED||||||Fisher Exact|||Comparison of the 3 groups for all-cause mortality.||||0.74
72384551|NCT01898208|144276772|SUPERIORITY_OR_OTHER|||||||0.42|TWO_SIDED||||||Fisher Exact|||Comparison of the 3 groups for attributable mortality.||||0.42
72384552|NCT01898208|144276773|SUPERIORITY_OR_OTHER|||||||0.82|TWO_SIDED||||||Fisher Exact|||This analysis is a comparison across all three groups.||||0.82
72384553|NCT01898208|144276775|SUPERIORITY_OR_OTHER|||||||0.7789|TWO_SIDED||||||Kruskal-Wallis|||Comparison between the 3 arms for total hospitalization costs.||||0.7789
72384554|NCT01898208|144276775|SUPERIORITY_OR_OTHER|||||||0.0006|TWO_SIDED||||||Kruskal-Wallis|||Comparison between the 3 arms for laboratory test cost.||||0.0006
72384555|NCT01898208|144276775|SUPERIORITY_OR_OTHER|||||||0.654|TWO_SIDED||||||Kruskal-Wallis|||Comparison between the 3 arms for antimicrobials costs.||||0.6540
72384556|NCT02435069|144276782|SUPERIORITY|||||||0.069751||||||significance level set at \<0.05 a priori|two-sample pooled variance t-test|Two-tailed||"Inferential statistical analysis was accomplished using a two-tailed, two-sample pooled variance t test with a significance level set at 0.05. and calculated on the data from the last day of the completed NS and USP Glycerin phases of the study.~Power analysis conducted using data from this study with α = 0.5, power of .80, correlation between two means of .598, and effect size of 1.554 estimated a sample size of 11 would be needed to minimize the risk of a Type II error to (20%)."||||0.069751
72384557|NCT02435069|144276783|SUPERIORITY|||||||0.172|||||||two-sample pooled variance t-test|two tailed||Inferential statistical analysis was accomplished using a two-tailed, two-sample pooled variance t test with a significance level set at 0.05. and calculated on the data from the last day of the completed NS and USP Glycerin phases of the study.||||0.172
72558389|NCT00957021|144646425|SUPERIORITY_OR_OTHER|||||||0.005|||||||t-test, 2 sided|||SF-36 Mental score comparison from pre-op to 4 year||||0.0050
72558390|NCT00957021|144646425|SUPERIORITY_OR_OTHER|||||||0.0018|||||||t-test, 2 sided|||SF-36 Mental score comparison from pre-op to 5 year||||0.0018
72384558|NCT02435069|144276786|SUPERIORITY|||||||0.8028|||||||two-sample pooled variance t-test|two-sided||Inferential statistical analysis was accomplished using a two-tailed, two-sample pooled variance t test with a significance level set at 0.05. and calculated on the data from the difference in calprotectin levels between samples obtained at baseline and samples obtained following the completion of the NS and USP Glycerin flush in the dosing phase of the study.||||0.8028
72384559|NCT02435069|144276787|SUPERIORITY|||||||0.346594|||||||two-sample pooled variance t test|two tailed||Inferential statistical analysis was accomplished using a two-tailed, two-sample pooled variance t test with a significance level set at 0.05. and calculated on the data from the last day of the completed NS and USP Glycerin phases of the study.||||0.346594
72384560|NCT02436681|144276791|SUPERIORITY||||||<|0.0001|||||||t-test, 1 sided|||||||<0.0001
72384561|NCT02436681|144276793|SUPERIORITY||||||=|0.0468|||||||t-test, 1 sided|||||||= 0.0468
72384562|NCT02436681|144276795|SUPERIORITY||||||=|0.014|||||||t-test, 1 sided|||||||=0.014
72384563|NCT02436681|144276796|SUPERIORITY||||||=|0.018|||||||t-test, 1 sided|||||||= 0.018
72384564|NCT01599832|144276808|OTHER|||||||0.083||||||P-value was from test of significance of log-transformed baseline K\^trans.|Regression, Cox|Multivariate model with adjustment for prior treatment, and clinical prognostic index (good/intermediate/poor) (n=16 had complete data)||||||0.083
72384565|NCT01739361|144276825|SUPERIORITY_OR_OTHER|||||||0.353|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.353
72384566|NCT01881373|144276828|SUPERIORITY|Hierarchical logistic model accounting for randomization of communities and clustering of children within communities in strata of jurisdictions weighted for number of children less than age 10 in communities. Chi-square test accounts for degrees of freedom based on number of communities.|Mean Difference (Final Values)|-3.88||||0.02|TWO_SIDED|95.0|-7.29|-0.47|||Regression, Logistic|Hierarchical model.|Intervention vs control communities comparing 24 months to baseline|||-0.47|-7.29|0.02
72384567|NCT01881373|144276828|SUPERIORITY|The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.|Mean Difference (Final Values)|-2.63||||0.28|TWO_SIDED|95.0|-8.58|3.32||The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.|Regression, Logistic|The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.||The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.||3.32|-8.58|0.28
72384568|NCT01881373|144276829|SUPERIORITY|Hierarchical model accounting for randomization of communities and clustering of children within communities in strata of jurisdictions weighted for number of children less than age 10 in communities. Chi-square test accounts for degrees of freedom based on number of communities.|Mean Difference (Final Values)|-1.64||||0.009|TWO_SIDED|95.0|-2.87|-0.41||Intervention vs control communities comparing 78 months to baseline.|Regression, Linear|Hierarchical model.||The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.||-0.41|-2.87|0.009
72384569|NCT01881373|144276829|SUPERIORITY|Hierarchical logistic model accounting for randomization of communities and clustering of children within communities in strata of jurisdictions weighted for number of children less than age 10 in communities. Chi-square test accounts for degrees of freedom based on number of communities.|Mean Difference (Final Values)|4.35||||0.49|TWO_SIDED|95.0|-8.5|17.24|||Regression, Linear|The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.||Intervention vs temporal comparing 78 months to baseline.||17.24|-8.5|0.49
72384570|NCT01881373|144276830|SUPERIORITY|Hierarchical logistic model accounting for randomization of communities and clustering of children within communities in strata of jurisdictions weighted for number of children less than age 10 in communities. Chi-square test accounts for degrees of freedom based on number of communities.|Difference in prevalence|-3.6|||<|0.01|TWO_SIDED||||||Regression, Logistic|Hierarchical model||Intervention vs control comparing 24 months to baseline.||||<0.01
72436768|NCT02954848|144386863|SUPERIORITY||Median Difference (Final Values)|0.02||||0.8138|TWO_SIDED|95.0|-0.12|0.15|||Wilcoxon Rank-Sum Test|||Statistical analysis for criteria 1, not improved response||0.1500|-0.1200|0.8138
72436769|NCT02954848|144386863|SUPERIORITY||Median Difference (Final Values)|-0.15||||0.0129|TWO_SIDED|95.0|-0.28|-0.03|||Wilcoxon Rank-Sum Test|||Statistical analysis for criteria 2, improved response||-0.0300|-0.2800|0.0129
72436770|NCT02954848|144386863|SUPERIORITY||Median Difference (Final Values)|0.17||||0.0765|TWO_SIDED|95.0|-0.01|0.36|||Wilcoxon Rank-Sum Test|||Statistical analysis for criteria 2, not improved response||0.3600|-0.0100|0.0765
72436771|NCT02954848|144386864|SUPERIORITY||Median Difference (Final Values)|6.5||||0.149|TWO_SIDED|95.0|-1.9|15.3|||Wilcoxon Rank-Sum Test|||Statistical analysis for Grade N of endoscopic findings||15.300|-1.900|0.1490
72436772|NCT02954848|144386864|SUPERIORITY||Median Difference (Final Values)|3.6||||0.2146|TWO_SIDED|95.0|-1.4|10.7|||Wilcoxon Rank-Sum Test|||Statistical analysis for Grade M of endoscopic findings||10.700|-1.400|0.2146
72436773|NCT02954848|144386865|SUPERIORITY|||||||0.0059|||||||Log Rank|||||||0.0059
72436774|NCT02954848|144386866|SUPERIORITY|||||||0.0153|||||||Log Rank|||||||0.0153
72436775|NCT02954848|144386867|SUPERIORITY||Median Difference (Final Values)|-0.18||||0.0757|TWO_SIDED|95.0|-0.43|0.02|||Wilcoxon Rank-Sum Test|||Statistical analysis for Grade N of endoscopic findings||0.0200|-0.4300|0.0757
72436776|NCT02954848|144386867|SUPERIORITY||Median Difference (Final Values)|-0.07||||0.3837|TWO_SIDED|95.0|-0.22|0.09|||Wilcoxon Rank-Sum Test|||Statistical analysis for Grade M of endoscopic findings||0.0900|-0.2200|0.3837
72436777|NCT02954848|144386868|SUPERIORITY||Median Difference (Final Values)|0.0||||0.6631|TWO_SIDED|95.0|-5.0|3.5|||Wilcoxon Rank-Sum Test|||Statistical analysis for Criteria 1, Grade N and improved response||3.500|-5.000|0.6631
72436778|NCT02954848|144386868|SUPERIORITY||Median Difference (Final Values)|3.2||||0.5627|TWO_SIDED|95.0|-7.1|13.9|||Wilcoxon Rank-Sum Test|||Statistical analysis for Criteria 1, Grade N and not improved response||13.900|-7.100|0.5627
72436779|NCT02954848|144386868|SUPERIORITY||Median Difference (Final Values)|3.7||||0.0042|TWO_SIDED|95.0|0.0|8.0|||Wilcoxon Rank-Sum Test|||Statistical analysis for Criteria 1, Grade M and improved response||8.000|0.000|0.0042
72436780|NCT02954848|144386868|SUPERIORITY||Median Difference (Final Values)|-0.7||||0.6452|TWO_SIDED|95.0|-9.4|6.4|||Wilcoxon Rank-Sum Test|||Statistical analysis for Criteria 1, Grade M and not improved response||6.400|-9.400|0.6452
72395199|NCT05355805|144297054|SUPERIORITY||Risk Difference (RD)|10.14|STANDARD_ERROR_OF_MEAN|7.229||0.1606|TWO_SIDED|||||The estimated risk difference divided by the standard error was used as the test statistic and a p-value calculated assuming that the test statistic follows a standard normal distribution under the null hypothesis.|Cochran-Mantel-Haenszel|||"The common risk difference between placebo QW/Q2W and the izokibep 160 mg QW arm among the four strata, prior biologic/JAK inhibitor use for HS (Yes/No) and Hurley Stage (II or III), used for randomization and associated standard error will be estimated by combining the observed risk differences using Cochran-Mantel-Haenszel weighting.~Non-response imputation was used for participants with missing HiSCR90."||||0.1606
72494757|NCT02340663|144518963|OTHER|||||||0.287||||||The P-value refers to the main effect of treatment group, i.e., differences between SOVA bite splints and Michigan bite splints.|Wilcoxon (Mann-Whitney)|||||||0.287
72494758|NCT02340663|144518964|OTHER|||||||0.505||||||The P-value refers to the main effect of treatment group, i.e., differences between SOVA bite splints and Michigan bite splints.|Wilcoxon (Mann-Whitney)|||||||0.505
72494759|NCT02340663|144518965|OTHER|||||||0.643||||||The P-value refers to the main effect of treatment group, i.e., differences between SOVA bite splints and Michigan bite splints.|Wilcoxon (Mann-Whitney)|||||||0.643
72494760|NCT02340663|144518966|OTHER|||||||0.923||||||The P-value refers to the main effect of treatment group, i.e., differences between SOVA bite splints and Michigan bite splints.|Wilcoxon (Mann-Whitney)|||||||0.923
72494761|NCT02979431|144518967|SUPERIORITY||||||<|0.001|||||||Log Rank|||The primary endpoint was analysed using log-rank test to compare time-to-BQL between each of the ALX-0171 treatment groups and the combined placebo group. The tests were performed in a sequential way to preserve the family-wise error rate at 0.05.||||<0.001
72494762|NCT02979431|144518967|SUPERIORITY||||||=|0.001|||||||Log Rank|||The primary endpoint was analysed using log-rank test to compare time-to-BQL between each of the ALX-0171 treatment groups and the combined placebo group. The tests were performed in a sequential way to preserve the family-wise error rate at 0.05.||||=0.001
72494763|NCT02979431|144518967|SUPERIORITY||||||<|0.001|||||||Log Rank|||The primary endpoint was analysed using log-rank test to compare time-to-BQL between each of the ALX-0171 treatment groups and the combined placebo group. The tests were performed in a sequential way to preserve the family-wise error rate at 0.05.||||<0.001
72494764|NCT02979431|144518968|SUPERIORITY||Mean Difference (Net)|-0.6452|STANDARD_ERROR_OF_MEAN|0.5843|=|0.271|TWO_SIDED||||||Mixed Models Analysis|||A comparison for change from Baseline in GSS to Day 2, 5 hours post-dose was performed using a contrast analysis on a longitudinal mixed model with random factor subject and fixed effects baseline value, treatment group and timepoint, including the treatment-by-timepoint interaction term. All data up to + including Day 3 were used in the longitudinal mixed model. The Kenward-Roger approximation of degrees of freedom was used.The model was fitted using an unstructured variance-covariance matrix.||||=0.271
72494765|NCT02979431|144518968|SUPERIORITY||Difference in LS means|-0.4904|STANDARD_ERROR_OF_MEAN|0.5862|=|0.404|TWO_SIDED||||||Mixed Models Analysis|||||||=0.404
72494766|NCT02979431|144518968|SUPERIORITY||Difference in LS means|-0.2156|STANDARD_ERROR_OF_MEAN|0.5842|=|0.713|TWO_SIDED||||||Mixed Models Analysis|||||||=0.713
72436781|NCT02954848|144386868|SUPERIORITY||Median Difference (Final Values)|7.4||||0.0376|TWO_SIDED|95.0|0.0|17.8|||Wilcoxon Rank-Sum Test|||Statistical analysis for Criteria 2, Grade N and improved response||17.800|0.000|0.0376
72494767|NCT01235962|144518984|SUPERIORITY||Adjusted Hazard Ratio|0.862||||0.1649|TWO_SIDED|95.0|0.699|1.063|||Stratified Log-Rank|||||1.063|0.699|0.1649
72436782|NCT02954848|144386868|SUPERIORITY||Median Difference (Final Values)|-13.0||||0.16|TWO_SIDED|95.0|-35.7|3.6|||Wilcoxon Rank-Sum Test|||Statistical analysis for Criteria 2, Grade N and not improved response||3.600|-35.700|0.1600
72494768|NCT01235962|144518985|SUPERIORITY||Adjusted Hazard Ratio|0.998||||0.988|TWO_SIDED|95.0|0.759|1.311|||Stratified Log-Rank|||||1.311|0.759|0.9880
72494769|NCT01235962|144518987|SUPERIORITY||Adjusted Hazard Ratio|0.802||||0.0126|TWO_SIDED|95.0|0.675|0.954|||Stratified Log-Rank|||||0.954|0.675|0.0126
72436783|NCT02954848|144386868|SUPERIORITY||Median Difference (Final Values)|3.6||||0.1032|TWO_SIDED|95.0|0.0|10.7|||Wilcoxon Rank-Sum Test|||Statistical analysis for Criteria 2, Grade M and improved response||10.700|0.000|0.1032
72436784|NCT02954848|144386868|SUPERIORITY||Median Difference (Final Values)|-3.3||||0.2613|TWO_SIDED|95.0|-14.3|0.2|||Wilcoxon Rank-Sum Test|||Statistical analysis for Criteria 2, Grade M and not improved response||0.200|-14.300|0.2613
72436785|NCT02954848|144386869|SUPERIORITY|||||||0.997|||||||Log Rank|||||||0.9970
72436786|NCT02954848|144386870|SUPERIORITY|||||||0.0125|||||||Log Rank|||||||0.0125
72436787|NCT02954848|144386871|SUPERIORITY|||||||0.0004|||||||Log Rank|||||||0.0004
72436788|NCT02954848|144386872|SUPERIORITY|||||||0.7999|||||||Log Rank|||||||0.7999
72436789|NCT02954848|144386873|SUPERIORITY|||||||0.0059|||||||Log Rank|||||||0.0059
72436790|NCT02954848|144386874|SUPERIORITY|||||||0.552|||||||Log Rank|||||||0.5520
72436791|NCT02954848|144386875|SUPERIORITY|||||||0.0175|||||||Log Rank|||||||0.0175
72436792|NCT02954848|144386876|SUPERIORITY|||||||0.7505|||||||Log Rank|||||||0.7505
72436793|NCT02954848|144386877|SUPERIORITY||Median Difference (Final Values)|-0.03||||0.7845|TWO_SIDED|95.0|-0.23|0.16|||Wilcoxon Rank-Sum Test|||Statistical analysis for Criteria 1, Grade N and improved response||0.1600|-0.2300|0.7845
72436794|NCT02954848|144386877|SUPERIORITY||Wilcoxon Rank-Sum Test|-0.11||||0.4456|TWO_SIDED|95.0|-0.33|0.17|||Wilcoxon Rank-Sum Test|||Statistical analysis for Criteria 1, Grade N and not improved response||0.1700|-0.3300|0.4456
72436795|NCT02954848|144386877|SUPERIORITY||Median Difference (Final Values)|-0.15||||0.02|TWO_SIDED|95.0|-0.29|-0.02|||Wilcoxon Rank-Sum Test|||Statistical analysis for Criteria 1, Grade M and improved response||-0.0200|-0.2900|0.0200
72436796|NCT02954848|144386877|SUPERIORITY||Median Difference (Final Values)|0.06||||0.4673|TWO_SIDED|95.0|-0.1|0.22|||Wilcoxon Rank-Sum Test|||Statistical analysis for Criteria 1, Grade M and not improved response||0.2200|-0.1000|0.4673
72436797|NCT02954848|144386877|SUPERIORITY||Median Difference (Final Values)|-0.29||||0.0095|TWO_SIDED|95.0|-0.53|-0.07|||Wilcoxon Rank-Sum Test|||Statistical analysis for Criteria 2, Grade N and improved response||-0.0700|-0.5300|0.0095
72436798|NCT02954848|144386877|SUPERIORITY||Median Difference (Final Values)|0.31||||0.165|TWO_SIDED|95.0|-0.16|0.71|||Wilcoxon Rank-Sum Test|||Statistical analysis for Criteria 2, Grade N and not improved response||0.7100|-0.1600|0.1650
72436799|NCT02954848|144386877|SUPERIORITY||Median Difference (Final Values)|-0.08||||0.2475|TWO_SIDED|95.0|-0.24|0.07|||Wilcoxon Rank-Sum Test|||Statistical analysis for Criteria 2, Grade M and improved response||0.0700|-0.2400|0.2475
72436800|NCT02954848|144386877|SUPERIORITY||Median Difference (Final Values)|0.13||||0.2367|TWO_SIDED|95.0|-0.09|0.32|||Wilcoxon Rank-Sum Test|||Statistical analysis for Criteria 2, Grade M and not improved||0.3200|-0.0900|0.2367
72436801|NCT02954848|144386878|SUPERIORITY||Median Difference (Final Values)|5.5||||0.1885|TWO_SIDED|95.0|-2.7|14.3|||Wilcoxon Rank-Sum Test|||Statistical analysis for improved response||14.300|-2.700|0.1885
72436802|NCT02954848|144386878|SUPERIORITY||Wilcoxon Rank-Sum Test|25.6||||0.2337|TWO_SIDED|95.0|-19.2|75.0|||Wilcoxon Rank-Sum Test|||Statistical analysis for not improved response||75.000|-19.200|0.2337
72436803|NCT02954848|144386879|SUPERIORITY|||||||0.0811|||||||Log Rank|||||||0.0811
72436804|NCT02954848|144386880|SUPERIORITY|||||||0.0288|||||||Log Rank|||||||0.0288
72436805|NCT02954848|144386881|SUPERIORITY||Median Difference (Final Values)|-0.17||||0.1488|TWO_SIDED|95.0|-0.42|0.04|||Wilcoxon Rank-Sum Test|||Statistical analysis for improved response||0.0400|-0.4200|0.1488
72494770|NCT01235962|144518988|SUPERIORITY||Adjusted Hazard Ratio|1.001||||0.9959|TWO_SIDED|95.0|0.796|1.257|||Stratified Log-Rank|||||1.257|0.796|0.9959
72384571|NCT01881373|144276831|SUPERIORITY|The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.|change in prevalence between communities|-12.6||||0.003|TWO_SIDED|95.0|-20.92|-4.28||The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.|Regression, Logistic|The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.|The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.|Intervention vs. control. The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.||-4.28|-20.92|0.003
72384572|NCT01881373|144276831|SUPERIORITY|The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.|Mean Difference (Final Values)|-3.43||||0.33|TWO_SIDED|95.0|-10.36|3.5||The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.|Regression, Logistic|The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.||Intervention vs. Temporal communities. The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.||3.50|-10.36|0.33
72384573|NCT01881373|144276832|SUPERIORITY|The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.|Mean Difference (Final Values)|-0.71||||0.02|TWO_SIDED|95.0|-1.37|-0.05||The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.|Regression, Linear|The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.|The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.|The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.||-0.05|-1.37|0.02
72384574|NCT01881373|144276832|SUPERIORITY|The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.|Mean Difference (Final Values)|-0.65||||0.13|TWO_SIDED|95.0|-1.79|0.49||The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.|Regression, Linear|The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.||The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.||0.49|-1.79|0.13
72384575|NCT01881373|144276833|SUPERIORITY|Hierarchical linear model accounting for randomization of communities and clustering of children within communities in strata of jurisdictions weighted for number of children less than age 10 in communities. Chi-square test accounts for degrees of freedom based on number of communities.The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.|Mean Difference (Final Values)|0.01||||0.86|TWO_SIDED||||||Regression, Linear|Hierarchical model.||Intervention vs control comparing 24 months to baseline.||||0.86
72384576|NCT01881373|144276834|SUPERIORITY|Hierarchical linear model accounting for randomization of communities and clustering of children within communities in strata of jurisdictions weighted for number of children less than age 10 in communities. Chi-square test accounts for degrees of freedom based on number of communities.|Mean Difference (Final Values)|-1.17||||0.68|TWO_SIDED||||||Regression, Linear|||Intervention vs control comparing 24 months to baseline.||||0.68
72436806|NCT02954848|144386881|SUPERIORITY||Wilcoxon Rank-Sum Test|-0.44||||0.3778|TWO_SIDED|95.0|-1.57|0.69|||Wilcoxon Rank-Sum Test|||Statistical analysis for not improved response||0.6900|-1.5700|0.3778
72436807|NCT02326649|144386896|OTHER|||||||0.47|||||||paired t-test|||||||0.47
72436808|NCT02326649|144386896|OTHER||Mean Difference (Final Values)|6.561|STANDARD_ERROR_OF_MEAN|5.528||0.255|TWO_SIDED|95.0|-5.295|18.417|||Regression, Linear|||Intercept for multilinear regression for difference in stroke volume controlling for difference in heart rate and blood pressure||18.417|-5.295|0.255
72436809|NCT02326649|144386896|OTHER||Mean Difference (Final Values)|0.5|STANDARD_ERROR_OF_MEAN|0.417||0.25|TWO_SIDED|95.0|-0.395|1.395|||Regression, Linear|||Heart rate delta for multilinear regression for difference in stroke volume controlling for difference in heart rate and blood pressure||1.395|-0.395|0.250
72436810|NCT02326649|144386896|OTHER||Mean Difference (Final Values)|-0.427|STANDARD_ERROR_OF_MEAN|0.305||0.183|TWO_SIDED|95.0|-1.081|0.227|||Regression, Linear|||Diastolic BP delta for multilinear regression for difference in stroke volume controlling for difference in heart rate and blood pressure||0.227|-1.081|0.183
72494771|NCT01235962|144518990|SUPERIORITY||Adjusted Hazard Ratio|0.693||||0.0201|TWO_SIDED|95.0|0.51|0.943|||Stratified Log-Rank|||||0.943|0.510|0.0201
72494772|NCT01235962|144518991|SUPERIORITY||Adjusted Hazard Ratio|1.004||||0.9865|TWO_SIDED|95.0|0.662|1.521|||Stratified Log-Rank|||||1.521|0.662|0.9865
72494773|NCT01235962|144518992|SUPERIORITY||Mean Difference (Week 52)|-3.397|||<|0.001|TWO_SIDED|95.0|-4.486|-2.307|||analysis of covariance|adjusted for baseline score using mixed-model||||-2.307|-4.486|<.001
72494774|NCT01235962|144518992|SUPERIORITY||Mean Difference (24M DFS FU)|-0.043||||0.93|TWO_SIDED|95.0|-1.003|0.917|||analysis of covariance|adjusted for baseline score using mixed-model||||0.917|-1.003|0.930
72494775|NCT01235962|144518992|SUPERIORITY||Mean Difference (36M DFS FU)|0.119||||0.828|TWO_SIDED|95.0|-0.958|1.196|||analysis of covariance|adjusted for baseline score using mixed-model||||1.196|-0.958|0.828
72494776|NCT01235962|144518992|SUPERIORITY||Mean Difference (48M DFS FU)|-0.347||||0.603|TWO_SIDED|95.0|-1.658|0.964|||analysis of covariance|adjusted for baseline score using mixed-model||||0.964|-1.658|0.603
72494777|NCT01235962|144518992|SUPERIORITY||Mean Difference (54M DFS FU)|-0.17||||0.841|TWO_SIDED|95.0|-1.843|1.503|||analysis of covariance|adjusted for baseline score using mixed-model||||1.503|-1.843|0.841
72494778|NCT01235962|144518993|SUPERIORITY||Mean Difference (Week 52)|-1.619|||<|0.001|TWO_SIDED|95.0|-2.283|-0.955|||analysis of covariance|adjusted for baseline score using mixed-model||||-0.955|-2.283|<.001
72494779|NCT01235962|144518993|SUPERIORITY||Mean Difference (24 M DFS FU)|-0.114||||0.726|TWO_SIDED|95.0|-0.75|0.522|||analysis of covariance|adjusted for baseline score using mixed-model||||0.522|-0.750|0.726
72494780|NCT01235962|144518993|SUPERIORITY||Mean Difference (36 M DFS FU)|-0.09||||0.801|TWO_SIDED|95.0|-0.789|0.609|||analysis of covariance|adjusted for baseline score using mixed-model||||0.609|-0.789|0.801
72494781|NCT01235962|144518993|SUPERIORITY||Meat Difference (48 M DFS FU)|-0.212||||0.617|TWO_SIDED|95.0|-1.044|0.32|||analysis of covariance|adjusted for baseline score using mixed-model||||0.320|-1.044|0.617
72494782|NCT01235962|144518993|SUPERIORITY||Mean Difference (54 M DFS FU)|0.341||||0.565|TWO_SIDED|95.0|-0.828|1.51|||adjusted for baseline score using mixedm|||||1.510|-0.828|0.565
72494783|NCT01235962|144518994|SUPERIORITY||Mean Difference (Week 52)|-0.077||||0.238|TWO_SIDED|95.0|-0.205|0.051|||analysis of covariance|adjusted for baseline score using mixed-model||||0.051|-0.205|0.238
72384577|NCT01881373|144276835|SUPERIORITY|Hierarchical linear model accounting for randomization of communities and clustering of children within communities in strata of jurisdictions weighted for number of children less than age 10 in communities. Chi-square test accounts for degrees of freedom based on number of communities.|Mean Difference (Final Values)|3.42||||0.55|TWO_SIDED||||||Regression, Linear|||Intervention vs control comparing 24 months to baseline.||||0.55
72384578|NCT01881373|144276836|SUPERIORITY|Hierarchical linear model accounting for randomization of communities and clustering of children within communities in strata of jurisdictions weighted for number of children less than age 10 in communities. Chi-square test accounts for degrees of freedom based on number of communities.|Mean Difference (Final Values)|-0.5||||0.11|TWO_SIDED||||||Regression, Linear|||Intervention vs control comparing 24 months to baseline.||||0.11
72384579|NCT01881373|144276837|SUPERIORITY|Hierarchical linear model accounting for randomization of communities and clustering of children within communities in strata of jurisdictions weighted for number of children less than age 10 in communities. Chi-square test accounts for degrees of freedom based on number of communities.|Mean Difference (Final Values)|-0.7||||0.08|TWO_SIDED||||||Regression, Linear|||mixed model adjusting for age and sex and cluster of community and strata of jurisdiction; intervention vs control comparing 24 months to baseline||||0.08
72384580|NCT01881373|144276838|SUPERIORITY|Hierarchical linear model accounting for randomization of communities and clustering of children within communities in strata of jurisdictions weighted for number of children less than age 10 in communities. Chi-square test accounts for degrees of freedom based on number of communities.|Mean Difference (Final Values)|-0.04||||0.71|TWO_SIDED||||||Regression, Linear|Hierarchical model.||Intervention vs control comparing 24 months to baseline.||||0.71
72384581|NCT01881373|144276839|SUPERIORITY|Hierarchical linear model accounting for randomization of communities and clustering of children within communities in strata of jurisdictions weighted for number of children less than age 10 in communities. Chi-square test accounts for degrees of freedom based on number of communities.|Mean Difference (Final Values)|-0.02||||0.54|TWO_SIDED||||||Regression, Linear|Hierarchical model.||Intervention vs control comparing 24 months to baseline.||||0.54
72384582|NCT01881373|144276840|SUPERIORITY|Hierarchical linear model accounting for randomization of communities and clustering of children within communities in strata of jurisdictions weighted for number of children less than age 10 in communities. Chi-square test accounts for degrees of freedom based on number of communities.|Mean Difference (Final Values)|-0.01||||0.9|TWO_SIDED||||||Regression, Linear|||Intervention vs control comparing 24 months to baseline.||||0.90
72384583|NCT01881373|144276841|SUPERIORITY|Hierarchical linear model accounting for randomization of communities and clustering of children within communities in strata of jurisdictions weighted for number of children less than age 10 in communities. Chi-square test accounts for degrees of freedom based on number of communities.|Mean Difference (Final Values)|-0.05||||0.71|TWO_SIDED||||||Regression, Linear|||Intervention vs control comparing 24 months to baseline.||||0.71
72384584|NCT01881373|144276842|SUPERIORITY|Hierarchical linear model accounting for randomization of communities and clustering of children within communities in strata of jurisdictions weighted for number of children less than age 10 in communities. Chi-square test accounts for degrees of freedom based on number of communities.|Mean Difference (Final Values)|-0.18||||0.48|TWO_SIDED|||||intervention vs control communities|Regression, Linear|||Intervention vs control comparing 24 months to baseline.||||0.48
72384585|NCT01881373|144276843|SUPERIORITY|The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.|differences in prevalence|-3.6|||<|0.01|TWO_SIDED|||||The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.|Regression, Logistic|Hierarchical model||intervention vs control. The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.||||<0.01
72384586|NCT01881373|144276844|SUPERIORITY|Hierarchical|Mean Difference (Final Values)|0.09||||0.44|TWO_SIDED|||||The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.|Regression, Linear|The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.||Intervention vs Control. The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.||||0.44
72494784|NCT01235962|144518994|SUPERIORITY||Mean Difference (24M DFS FU)|-0.052||||0.442|TWO_SIDED|95.0|-0.185|0.081|||analysis of covariance|adjusted for baseline score using mixed-model||||0.081|-0.185|0.442
72494785|NCT01235962|144518994|SUPERIORITY||Mean Difference (36M DFS FU)|0.016||||0.819|TWO_SIDED|95.0|-0.125|0.158|||analysis of covariance|adjusted for baseline score using mixed-model||||0.158|-0.125|0.819
72558391|NCT00957021|144646427|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||LEAS score comparison from pre-op to 1, 2, 3, 4 and 5 years||||<.0001
72436811|NCT02326649|144386896|OTHER||Mean Difference (Final Values)|0.557|STANDARD_ERROR_OF_MEAN|0.452||0.238|TWO_SIDED|95.0|-0.411|1.526|||Regression, Linear|||Systolic BP delta for multilinear regression for difference in stroke volume controlling for difference in heart rate and blood pressure||1.526|-0.411|0.238
72436812|NCT03698708|144386899|SUPERIORITY||cohen's d|0.88|||||TWO_SIDED||||||repeated measures ANOVA|||||||
72436813|NCT03698708|144386900|SUPERIORITY||cohen's d|0.22|||||TWO_SIDED||||||repeated measures ANOVA|||||||
72494786|NCT01235962|144518994|SUPERIORITY||Mean Difference (48M DFS FU)|-0.119||||0.223|TWO_SIDED|95.0|-0.311|0.073|||analysis of covariance|analysis of covariance adjusted for baseline score using mixed-model||||0.073|-0.311|0.223
72494787|NCT01235962|144518994|SUPERIORITY||Mean Difference (54M DFS FU)|-0.203||||0.085|TWO_SIDED|95.0|-0.435|0.028|||analysis of covariance|adjusted for baseline score using mixed-model||||0.028|-0.435|0.085
72494788|NCT01235962|144518995|SUPERIORITY||Mean Difference (Week 52)|-1.394|||<|0.001|TWO_SIDED|95.0|-1.66|-1.129|||analysis of covariance|adjusted for baseline score using mixed-model||||-1.129|-1.660|<.001
72494789|NCT01235962|144518995|SUPERIORITY||Mean difference (24M DFS FU)|0.117||||0.083|TWO_SIDED|95.0|-0.015|0.249|||analysis of covariance|adjusted for baseline score using mixed-model||||0.249|-0.015|0.083
72494790|NCT01235962|144518995|SUPERIORITY||Mean Difference (36M DFS FU)|0.081||||0.307|TWO_SIDED|95.0|-0.074|0.236|||analysis of covariance|adjusted for baseline score using mixed-model||||0.236|-0.074|0.307
72494791|NCT01235962|144518995|SUPERIORITY||Mean Difference (48M DFS FU)|-0.029||||0.796|TWO_SIDED|95.0|-0.249|0.191|||analysis of covariance|adjusted for baseline score using mixed-model||||0.191|-0.249|0.796
72494792|NCT01235962|144518995|SUPERIORITY||Mean Difference (54M DFS FU)|-0.016||||0.885|TWO_SIDED|95.0|-0.237|0.205|||analysis of covariance|adjusted for baseline score using mixed-models||||0.205|-0.237|0.885
72494793|NCT01235962|144518996|SUPERIORITY||Mean Differencec (Week 52)|-0.27||||0.143|TWO_SIDED|95.0|-0.633|0.092|||analysis of covariance|adjusted for baseline score using mixed-model||||0.092|-0.633|0.143
72494794|NCT01235962|144518996|SUPERIORITY||Mean Difference (24M DFS FU)|0.069||||0.736|TWO_SIDED|95.0|-0.336|0.475|||analysis of covariance|adjusted for baseline score using mixed-model||||0.475|-0.336|0.736
72494795|NCT01235962|144518996|SUPERIORITY||Mean Difference (36M DFS FU)|0.188||||0.397|TWO_SIDED|95.0|-0.247|0.623|||analysis of covariance|adjusted for baseline score using mixed-model||||0.623|-0.247|0.397
72494796|NCT01235962|144518996|SUPERIORITY||Mean Difference (48M DFS FU)|0.081||||0.781|TWO_SIDED|95.0|-0.488|0.649|||analysis of covariance|adjusted for baseline score using mixed-model||||0.649|-0.488|0.781
72494797|NCT01235962|144518996|SUPERIORITY||Mean Difference (54M DFS FU)|-0.278||||0.503|TWO_SIDED|95.0|-1.094|0.539|||analysis of covariance|adjusted for baseline score using mixed-model||||0.539|-1.094|0.503
72436814|NCT03698708|144386901|SUPERIORITY||cohen's d|0.05|||||TWO_SIDED||||||repeated measures ANOVA|||||||
72494798|NCT01235962|144518997|SUPERIORITY||Mean Difference (Week 52 thermo)|-0.717||||0.49|TWO_SIDED|95.0|-2.751|1.318|||analysis of covariance|adjusted for baseline score using mixed-model||||1.318|-2.751|0.490
72494799|NCT01235962|144518997|SUPERIORITY||Mean Difference (24M DFS FU- thermo)|-0.285||||0.788|TWO_SIDED|95.0|-2.358|1.788|||analysis of covariance|adjusted for baseline score using mixed-model||||1.788|-2.358|0.788
72494800|NCT01235962|144518997|SUPERIORITY||Mean Difference (36M DFS FU- thermo)|1.18||||0.266|TWO_SIDED|95.0|-0.901|3.262|||analysis of covariance|adjusted for baseline score using mixed-model||||3.262|-0.901|0.266
72494801|NCT01235962|144518997|SUPERIORITY||Mean Difference (48M DFS FU - thermo)|0.725||||0.57|TWO_SIDED|95.0|-1.779|3.229|||analysis of covariance|adjusted for baseline score using mixed-model||||3.229|-1.779|0.570
72494802|NCT01235962|144518997|SUPERIORITY||Mean Difference (54M DFS FU - thermo)|2.023||||0.346|TWO_SIDED|95.0|-2.205|6.251|||analysis of covariance|adjusted for baseline score using mixed-model||||6.251|-2.205|0.346
72494803|NCT01235962|144518997|SUPERIORITY||Mean Difference (Week 52 - UI)|-0.018||||0.111|TWO_SIDED|95.0|-0.04|0.004|||analysis of covariance|adjusted for baseline score using mixed-model||||0.004|-0.040|0.111
72494804|NCT01235962|144518997|SUPERIORITY||Mean Difference (24M DFS FU - UI)|-0.02||||0.094|TWO_SIDED|95.0|-0.044|0.003|||analysis of covariance|adjusted for baseline score using mixed-model||||0.003|-0.044|0.094
72494805|NCT01235962|144518997|SUPERIORITY||Mean Difference (36M DFS FU - UI)|0.01||||0.49|TWO_SIDED|95.0|-0.018|0.037|||analysis of covariance|adjusted for baseline score using mixed-model||||0.037|-0.018|0.490
72494806|NCT01235962|144518997|SUPERIORITY||Mean Difference (48M DFS FU - UI)|-0.009||||0.58|TWO_SIDED|95.0|-0.043|0.024|||analysis of covariance|adjusted for baseline score using mixed-model||||0.024|-0.043|0.580
72494807|NCT01235962|144518997|SUPERIORITY||Mean Difference (54M DFS FU - UI)|0.017||||0.473|TWO_SIDED|95.0|-0.029|0.063|||analysis of covariance|adjusted for baseline score using mixed-model||||0.063|-0.029|0.473
72494808|NCT01235962|144518998|SUPERIORITY||Mean Difference (Week 52)|-3.536|||<|0.001|TWO_SIDED|95.0|-4.466|-2.606|||analysis of covariance|adjusted for baseline score using mixed-model||||-2.606|-4.466|<.001
72494809|NCT01235962|144518998|SUPERIORITY||Mean difference (24M DFS FU)|-0.102||||0.812|TWO_SIDED|95.0|-0.942|0.738|||analysis of covariance|adjusted for baseline score using mixed-model||||0.738|-0.942|0.812
72494810|NCT01235962|144518998|SUPERIORITY||Mean Difference (36M DFS FU)|0.233||||0.621|TWO_SIDED|95.0|-0.69|1.155|||analysis of covariance|adjusted for baseline score using mixed-model||||1.155|-0.690|0.621
72494811|NCT01235962|144518998|SUPERIORITY||Mean Difference (48M DFS FU)|0.082||||0.878|TWO_SIDED|95.0|-0.959|1.122|||analysis of covariance|adjusted for baseline score using mixed-model||||1.122|-0.959|0.878
72494812|NCT01235962|144518998|SUPERIORITY||Mean Difference (54M DFS FU)|0.412||||0.533|TWO_SIDED|95.0|-0.887|1.712|||analysis of covariance|adjusted for baseline score using mixed-model||||1.712|-0.887|0.533
72494813|NCT01235962|144518999|SUPERIORITY||Mean Difference (Week 52)|-1.515|||<|0.001|TWO_SIDED|95.0|-2.078|-0.952|||analysis of covariance|adjusted for baseline score using mixed-model||||-0.952|-2.078|<.001
72494814|NCT01235962|144518999|SUPERIORITY||Mean Difference (24M DFS FU)|0.014||||0.961|TWO_SIDED|95.0|-0.534|0.561|||analysis of covariance|adjusted for baseline score using mixed-model||||0.561|-0.534|0.961
72436815|NCT03698708|144386902|SUPERIORITY||cohen's d|0.14|||||TWO_SIDED||||||repeated measures ANOVA|||||||
72436816|NCT03698708|144386903|SUPERIORITY||cohen's d|0.09|||||TWO_SIDED||||||repeated measures ANOVA|||||||
72436817|NCT03698708|144386904|SUPERIORITY||Mean Difference (Final Values)|-4.16|||||TWO_SIDED|95.0|-10.07|1.74|||ANOVA|||||1.74|-10.07|
72436818|NCT03495713|144386908|OTHER||||||||||||||||||Descriptive analysis only based limited enrollments.|||
72436819|NCT04001517|144386909|SUPERIORITY||Mean Difference (Net)|0.175||||0.049|TWO_SIDED|95.0|0.001|0.345||The comparison is of neflamapimod 40mg TID to placebo. The p-value was not adjusted for multiple comparisons.|Mixed Models Analysis||The comparison is of neflamapimod 40mg TID to placebo. The positive value represents a better outcome with neflamapimod 40mg treatment vs. placebo.|This was an exploratory trial and no explicit a priori hypothesis was established and contained in the protocol. As such, no formal power calculations were conducted. The primary objective of the study was to evaluate the effects of neflamapimod on cognition, and accordingly the primary endpoint was change in combined z-score of the six tests in the NTB, analyzed by Linear Mixed Effects (LME) model for repeated measures.||0.345|0.001|0.049
72436820|NCT04001517|144386909|SUPERIORITY|Comparison of combined neflamapimod groups vs. placebo.|||||>|0.2|||||||Mixed Models Analysis|||||||>0.2
72494815|NCT01235962|144518999|SUPERIORITY||Mean Difference (36M DFS FU)|0.043||||0.888|TWO_SIDED|95.0|-0.555|0.641|||analysis of covariance|adjusted for baseline score using mixed-model||||0.641|-0.555|0.888
72494816|NCT01235962|144518999|SUPERIORITY||Mean Difference (48M DFS FU)|-0.061||||0.858|TWO_SIDED|95.0|-0.736|0.614|||analysis of covariance|adjusted for baseline score using mixed-model||||0.614|-0.736|0.858
72494817|NCT01235962|144518999|SUPERIORITY||Mean Difference (54M DFS FU)|0.452||||0.3|TWO_SIDED|95.0|-0.404|1.309|||analysis of covariance|adjusted for baseline score using mixed-model||||1.309|-0.404|0.300
72494818|NCT01235962|144519000|SUPERIORITY||Mean Difference (Week 52)|-0.103||||0.059|TWO_SIDED|95.0|-0.211|0.004|||analysis of covariance|adjusted for baseline score using mixed-model||||0.004|-0.211|0.059
72494819|NCT01235962|144519000|SUPERIORITY||Mean Difference (24M DFS FU)|-0.041||||0.487|TWO_SIDED|95.0|-0.155|0.074|||analysis of covariance|adjusted for baseline score using mixed-model||||0.074|-0.155|0.487
72494820|NCT01235962|144519000|SUPERIORITY||Mean Difference (36M DFS FU)|0.037||||0.885|TWO_SIDED|95.0|-0.085|0.16|||analysis of covariance|adjusted for baseline score using mixed-model||||0.160|-0.085|0.885
72384587|NCT01881373|144276845|SUPERIORITY|The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.|Mean Difference (Final Values)|0.16||||0.81|TWO_SIDED|||||The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.|Regression, Linear|The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.||Intervention vs. Control. The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.||||0.81
72384588|NCT01881373|144276846|SUPERIORITY|The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.|Mean Difference (Final Values)|0.37||||0.68|TWO_SIDED|||||The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.|Regression, Linear|The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.|The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.|The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.||||0.68
72384589|NCT01881373|144276847|SUPERIORITY|Hierarchical model. The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.|Mean Difference (Final Values)|0.02||||0.69|TWO_SIDED|||||The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.|Regression, Linear|The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.||Intervention vs control. The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.||||0.69
72494821|NCT01235962|144519000|SUPERIORITY||Mean Difference (48M DFS FU)|-0.032||||0.676|TWO_SIDED|95.0|-0.183|0.119|||analysis of covariance|adjusted for baseline score using mixed-model||||0.119|-0.183|0.676
72494822|NCT01235962|144519000|SUPERIORITY||Mean Difference (54M DFS FU)|-0.015||||0.859|TWO_SIDED|95.0|-0.183|0.153|||analysis of covariance|adjusted for baseline score using mixed-model||||0.153|-0.183|0.859
72494823|NCT01235962|144519001|SUPERIORITY||Mean Diffeence (Week 52)|-1.535|||<|0.001|TWO_SIDED|95.0|-1.769|-1.3|||analysis of covariance|adjusted for baseline score using mixed-model||||-1.300|-1.769|<.001
72494824|NCT01235962|144519001|SUPERIORITY||Mean Diffeence (24M DFS FU)|0.089||||0.127|TWO_SIDED|95.0|-0.025|0.202|||analysis of covariance|adjusted for baseline score using mixed-model||||0.202|-0.025|0.127
72494825|NCT01235962|144519001|SUPERIORITY||Mean Diffeence (36M DFS FU)|0.123||||0.069|TWO_SIDED|95.0|-0.009|0.255|||analysis of covariance|adjusted for baseline score using mixed-model||||0.255|-0.009|0.069
72494826|NCT01235962|144519001|SUPERIORITY||Mean Diffeence (48M DFS FU)|0.049||||0.544|TWO_SIDED|95.0|-0.11|0.208|||analysis of covariance|adjusted for baseline score using mixed-model||||0.208|-0.110|0.544
72494827|NCT01235962|144519001|SUPERIORITY||Mean Difference (54M DFS FU)|0.061||||0.518|TWO_SIDED|95.0|-0.124|0.246|||analysis of covariance|adjusted for baseline score using mixed-model||||0.246|-0.124|0.518
72494828|NCT01235962|144519002|SUPERIORITY||Mean Diffeence (Week 52)|-0.374||||0.022|TWO_SIDED|95.0|-0.695|-0.053|||analysis of covariance|adjusted for baseline score using mixed-model||||-0.053|-0.695|0.022
72494829|NCT01235962|144519002|SUPERIORITY||Mean Diffeence (24M DFS FU)|-0.104||||0.567|TWO_SIDED|95.0|-0.462|0.253|||analysis of covariance|adjusted for baseline score using mixed-model||||0.253|-0.462|0.567
72494830|NCT01235962|144519002|SUPERIORITY||Mean Difference (36M DFS FU)|0.072||||0.706|TWO_SIDED|95.0|-0.302|0.446|||analysis of covariance|adjusted for baseline score using mixed-model||||0.446|-0.302|0.706
72494831|NCT01235962|144519002|SUPERIORITY||Mean Difference (48M DFS FU)|0.12||||0.612|TWO_SIDED|95.0|-0.343|0.583|||analysis of covariance|adjusted for baseline score using mixed-model||||0.583|-0.343|0.612
72494832|NCT01235962|144519002|SUPERIORITY||Mean Difference (54M DFS FU)|-0.045||||0.87|TWO_SIDED|95.0|-0.587|0.496|||analysis of covariance|adjusted for baseline score using mixed-model||||0.496|-0.587|0.870
72494833|NCT01235962|144519003|SUPERIORITY||Mean Difference (Week 52 - thermo.)|-2.116||||0.018|TWO_SIDED|95.0|-3.872|-0.359|||analysis of covariance|adjusted for baseline score using mixed-model||||-0.359|-3.872|0.018
72494834|NCT01235962|144519003|SUPERIORITY||Mean Difference (24M DFS FU - thermo)|-0.253||||0.778|TWO_SIDED|95.0|-2.014|1.508|||analysis of covariance|adjusted for baseline score using mixed-model||||1.508|-2.014|0.778
72494835|NCT01235962|144519003|SUPERIORITY||Mean Difference (36M DFS FU - thermo)|0.847||||0.376|TWO_SIDED|95.0|-1.03|2.724|||analysis of covariance|adjusted for baseline score using mixed-model||||2.724|-1.030|0.376
72384590|NCT01881373|144276848|SUPERIORITY|Hierarchical model. The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.|Mean Difference (Final Values)|0.21||||0.11|TWO_SIDED|||||The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.|Regression, Linear||The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.|Intervention vs. control. The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.||||0.11
72384591|NCT01881373|144276849|SUPERIORITY|Hierarchical model. The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.|Mean Difference (Final Values)|0.06||||0.4|TWO_SIDED|||||The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.|Regression, Linear|||Intervention vs. control. The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.||||0.40
72384592|NCT01881373|144276850|SUPERIORITY|Hierarchical model. The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.|Mean Difference (Final Values)|0.2||||0.37|TWO_SIDED|||||The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.|Regression, Linear|The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.||Intervention vs control. The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.||||0.37
72384593|NCT01881373|144276850|SUPERIORITY|Hierarchical model.The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.|Mean Difference (Final Values)|0.18||||0.51|TWO_SIDED|||||The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.|Regression, Linear|The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.||Intervention vs temporal.The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.||||0.51
72384594|NCT02053051|144276884|SUPERIORITY|||||||0.87|||||||Wilcoxon (Mann-Whitney)|||||||0.87
72384595|NCT01854658|144276892|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|||At 5 min post dose||||<0.0001
72384596|NCT01854658|144276892|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|||At 15 min post dose||||<0.0001
72384597|NCT01854658|144276892|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|||At 5 min post dose||||<0.0001
72384598|NCT01854658|144276892|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|||At 15 min post dose||||<0.0001
72384599|NCT01854658|144276892|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|||At 5 min post dose||||<0.0001
72384600|NCT01854658|144276892|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|||At 15 min post dose||||<0.0001
72384601|NCT03894046|144276897|NON_INFERIORITY|"Non-inferiority was concluded if the upper limit of the 2-sided 95% CI was less than +20%.~Superiority was concluded if the upper limit of the 2-sided 95% CI was less than 0."|Mean Difference (Final Values)|-13.2|||||TWO_SIDED|95.0|-30.0|3.5||||||The non-inferiority assessment was based on the 2-sided 95% CIs computed using a continuity-corrected Z-statistic for the difference (\[sulbactam-durlobactam + imipenem/cilastatin\] - \[colistin + imipenem/cilastatin\]) in 28-day all-cause mortality rates between the treatment groups.||3.5|-30|
72494836|NCT01235962|144519003|SUPERIORITY||Mean Difference (48M DFS FU - thermo)|0.131||||0.905|TWO_SIDED|95.0|-2.032|2.294|||analysis of covariance|adjusted for baseline score using mixed-model||||2.294|-2.032|0.905
72494837|NCT01235962|144519003|SUPERIORITY||Mean Difference (54M DFS FU - thermo)|0.401||||0.768|TWO_SIDED|95.0|-2.269|3.071|||analysis of covariance|adjusted for baseline score using mixed-model||||3.071|-2.269|0.768
72384602|NCT03894046|144276898|OTHER|||||||0.0002||||||p-value was obtained based on a Chi-Square test for treatment group differences.|Chi-squared|||Analysis of patients with nephrotoxicity as measured by RIFLE criteria at any post-baseline visit based on the Investigator's opinion for the Safety Population for Part A, excluding patients with chronic hemodialysis at baseline baseline.||||0.0002
72384603|NCT03089320|144276905|SUPERIORITY||posterior mean proportion of abstinence|9.12|||||TWO_SIDED|95.0|0.08|31.68|||||The lower and upper limits are credible intervals.|Bayesian analysis was performed, therefore p value is not reported. Bayes factor has been reported instead.||31.68|0.08|
72384604|NCT03089320|144276906|SUPERIORITY||posterior mean proportion of abstinence|5.5|||||TWO_SIDED|95.0|0.17|18.23|||||The lower and upper limits are credible intervals.|Bayesian analysis was performed, therefore p value is not reported. Bayes factor has been reported instead.||18.23|0.17|
72384605|NCT03089320|144276907|SUPERIORITY||Mean Difference (Final Values)|-4.32|STANDARD_ERROR_OF_MEAN|2.84||0.05|TWO_SIDED|95.0|-9.97|1.34|||Mixed Models Analysis|||mixed effects model||1.34|-9.97|.05
72384606|NCT00785928|144276944|SUPERIORITY_OR_OTHER|||||||0.059||95.0||||This is p-value for the fitted ACR50 response rate and is based on the dose-response regression model and comes from the joint test of linear and quadratic dose response (response=dose+dose\^2) from the likelihood ratio test.|Linear-quadratic regression model|||||||0.059
72494838|NCT01235962|144519003|SUPERIORITY||Mean Difference (Week 52 - UI)|-0.026||||0.007|TWO_SIDED|95.0|-0.044|-0.007|||analysis of covariance|adjusted for baseline score using mixed-model||||-0.007|-0.044|0.007
72494839|NCT01235962|144519003|SUPERIORITY||Mean Difference (24M DFS FU - UI)|-0.016||||0.13|TWO_SIDED|95.0|-0.036|0.005|||analysis of covariance|adjusted for baseline score using mixed-model||||0.005|-0.036|0.130
72494840|NCT01235962|144519003|SUPERIORITY||Mean Difference (36M DFS FU - UI)|0.007||||0.52|TWO_SIDED|95.0|-0.015|0.03|||analysis of covariance|adjusted for baseline score using mixed-model||||0.030|-0.015|0.520
72494841|NCT01235962|144519003|SUPERIORITY||Mean Difference (48M DFS FU - UI)|-0.014||||0.276|TWO_SIDED|95.0|-0.04|0.011|||analysis of covariance|adjusted for baseline score using mixed-model||||0.011|-0.040|0.276
72494842|NCT01235962|144519003|SUPERIORITY||Mean Difference (54M DFS FU - UI)|-0.007||||0.665|TWO_SIDED|95.0|-0.037|0.024|||analysis of covariance|adjusted for baseline score using mixed-model||||0.024|-0.037|0.665
72558392|NCT01822119|144646433|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation|||||||<0.0001
72384607|NCT00785928|144276944|SUPERIORITY_OR_OTHER||ED95|119.0||||0.042||95.0||||This is the p-value for the estimated dose level of the smallest dose, in milligrams (mg), that achieves at least 95% of the maximal efficacy (ED95) and is based on the comparisons that the ED95 yields a higher fitted response rate than placebo.|Linear-quadratic regression model|This is ED95 in mg.||||||0.042
72384608|NCT00785928|144276945|SUPERIORITY_OR_OTHER|||||||0.044||95.0||||This is the p-value for the fitted ACR20 response rate and is based on the dose-response regression model and comes from the joint test of linear and quadratic dose response (response=dose+dose\^2) from the likelihood ratio test.|Linear-quadratic regression model|||||||0.044
72384609|NCT00785928|144276945|SUPERIORITY_OR_OTHER||ED95|118.5||||0.005||95.0||||This p-value is for estimated dose level of the smallest dose, in milligrams (mg), that achieves at least 95% of the maximal efficacy (ED95) of the ACR20 and is based on the comparisons that the ED95 yields a higher fitted response rate than placebo.|Linear-quadratic regression model|This is the ED95 in mg.||||||0.005
72384610|NCT00785928|144276946|SUPERIORITY_OR_OTHER|||||||0.623||95.0||||Pairwise comparison (2-sided) of 1 mg LY2127399 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as a covariate.|ANCOVA|||||||0.623
72384611|NCT00785928|144276946|SUPERIORITY_OR_OTHER|||||||0.16||95.0||||Pairwise comparison (2-sided) of 3 mg LY2127399 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as a covariate.|ANCOVA|||||||0.160
72384612|NCT00785928|144276946|SUPERIORITY_OR_OTHER|||||||0.568||95.0||||Pairwise comparison (2-sided) of 10 mg LY2127399 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as a covariate.|ANCOVA|||||||0.568
72384613|NCT00785928|144276946|SUPERIORITY_OR_OTHER|||||||0.633||95.0||||Pairwise comparison (2-sided) of 30 mg LY2127399 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as a covariate.|ANCOVA|||||||0.633
72384614|NCT00785928|144276946|SUPERIORITY_OR_OTHER|||||||0.754||95.0||||Pairwise comparison (2-sided) of 60 mg LY2127399 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as a covariate.|ANCOVA|||||||0.754
72384615|NCT00785928|144276946|SUPERIORITY_OR_OTHER|||||||0.289||95.0||||Pairwise comparison (2-sided) of 120 mg LY2127399 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as a covariate.|ANCOVA|||||||0.289
72384616|NCT00785928|144276947|SUPERIORITY_OR_OTHER|||||||0.671||95.0||||Pairwise comparison (2-sided) of 1 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as a covariate.|ANCOVA|||||||0.671
72384617|NCT00785928|144276947|SUPERIORITY_OR_OTHER|||||||0.696||95.0||||Pairwise comparison (2-sided) of 3 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as a covariate.|ANCOVA|||||||0.696
72384618|NCT00785928|144276947|SUPERIORITY_OR_OTHER|||||||0.367||95.0||||Pairwise comparison (2-sided) of 10 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as a covariate.|ANCOVA|||||||0.367
72384619|NCT00785928|144276947|SUPERIORITY_OR_OTHER|||||||0.645||95.0||||Pairwise comparison (2-sided) of 30 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as a covariate.|ANCOVA|||||||0.645
72384620|NCT00785928|144276947|SUPERIORITY_OR_OTHER|||||||0.944||95.0||||Pairwise comparison (2-sided) of 60 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as a covariate.|ANCOVA|||||||0.944
72384621|NCT00785928|144276947|SUPERIORITY_OR_OTHER|||||||0.133||95.0||||Pairwise comparison (2-sided) of 120 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as a covariate.|ANCOVA|||||||0.133
72384622|NCT00785928|144276948|SUPERIORITY_OR_OTHER|||||||0.457||95.0||||Pairwise comparison (1-sided) of 1 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as a covariate.|ANCOVA|||||||0.457
72384623|NCT00785928|144276948|SUPERIORITY_OR_OTHER|||||||0.874||95.0||||Pairwise comparison (1-sided) of 3 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as a covariate.|ANCOVA|||||||0.874
72384624|NCT00785928|144276948|SUPERIORITY_OR_OTHER|||||||0.278||95.0||||Pairwise comparison (1-sided) of 10 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as a covariate.|ANCOVA|||||||0.278
72384625|NCT00785928|144276948|SUPERIORITY_OR_OTHER|||||||0.357||95.0||||Pairwise comparison (1-sided) of 30 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as a covariate.|ANCOVA|||||||0.357
72384626|NCT00785928|144276948|SUPERIORITY_OR_OTHER|||||||0.271||95.0||||Pairwise comparison (1-sided) of 60 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as a covariate.|ANCOVA|||||||0.271
72384627|NCT00785928|144276948|SUPERIORITY_OR_OTHER|||||||0.048||95.0||||Pairwise comparison (1-sided) of 120 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as a covariate.|ANCOVA|||||||0.048
72384628|NCT00785928|144276949|SUPERIORITY_OR_OTHER|||||||0.875||95.0||||This p-value is from 2-sided comparison of 1 mg LY2127399 versus placebo using Fisher's exact test for the 3 levels of EULAR response (good, moderate, no).|Fisher Exact|||||||0.875
72436821|NCT04001517|144386910|SUPERIORITY|Comparison of combined neflamapimod 40mg TID vs. placebo. The p-value is not adjusted for multiple comparisons.|Mean Difference (Net)|-0.56||||0.007|TWO_SIDED|95.0|-0.96|-0.16||Comparison of combined neflamapimod dose groups vs. placebo utilizing mixed model for repeated measures with baseline as a covariate. The p-value is not adjusted for multiple comparisons.|Mixed Models Analysis||The comparison is of neflamapimod 40mg TID to placebo. A negative value indicates improvement compared to placebo.|||-0.16|-0.96|0.007
72384629|NCT00785928|144276949|SUPERIORITY_OR_OTHER|||||||1||95.0||||This p-value is from 2-sided comparison of 3 mg LY2127399 versus placebo using Fisher's exact test for the 3 levels of EULAR response (good, moderate, no).|Fisher Exact|||||||1.000
72384630|NCT00785928|144276949|SUPERIORITY_OR_OTHER|||||||1||95.0||||This p-value is from 2-sided comparison of 10 mg LY2127399 versus placebo using Fisher's exact test for the 3 levels of EULAR response (good, moderate, no).|Fisher Exact|||||||1.000
72384631|NCT00785928|144276949|SUPERIORITY_OR_OTHER|||||||0.304||95.0||||This p-value is from a 2-sided comparison of 30 mg LY2127399 versus placebo using a Chi-square test for the 3 levels of EULAR response (good, moderate, no).|Chi-squared|||||||0.304
72384632|NCT00785928|144276949|SUPERIORITY_OR_OTHER|||||||0.489||95.0||||This p-value is from a 2-sided comparison of 60 mg LY2127399 versus placebo using a Chi-square test for the 3 levels of EULAR response (good, moderate, no).|Chi-squared|||||||0.489
72384633|NCT00785928|144276949|SUPERIORITY_OR_OTHER|||||||0.091||95.0||||This p-value is from a 2-sided comparison of 120 mg LY2127399 versus placebo using a Chi-square test for the 3 levels of EULAR response (good, moderate, no).|Chi-squared|||||||0.091
72384634|NCT00785928|144276950|SUPERIORITY_OR_OTHER|||||||0.746||95.0||||Pairwise comparison (2-sided) of 1 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as a covariate.|ANCOVA|||||||0.746
72384635|NCT00785928|144276950|SUPERIORITY_OR_OTHER|||||||0.393||95.0||||Pairwise comparison (2-sided) of 3 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as a covariate.|ANCOVA|||||||0.393
72384636|NCT00785928|144276950|SUPERIORITY_OR_OTHER|||||||0.549||95.0||||Pairwise comparison (2-sided) of 10 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as a covariate.|ANCOVA|||||||0.549
72384637|NCT00785928|144276950|SUPERIORITY_OR_OTHER|||||||0.619||95.0||||Pairwise comparison (2-sided) of 30 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as a covariate.|ANCOVA|||||||0.619
72384638|NCT00785928|144276950|SUPERIORITY_OR_OTHER|||||||0.893||95.0||||Pairwise comparison (2-sided) of 60 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as a covariate.|ANCOVA|||||||0.893
72384639|NCT00785928|144276950|SUPERIORITY_OR_OTHER|||||||0.066||95.0||||Pairwise comparison (2-sided) of 120 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as a covariate.|ANCOVA|||||||0.066
72384640|NCT00785928|144276951|SUPERIORITY_OR_OTHER|||||||0.583||95.0||||Pairwise comparison (2-sided) of 1 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as a covariate.|ANCOVA|||||||0.583
72384641|NCT00785928|144276951|SUPERIORITY_OR_OTHER|||||||0.311||95.0||||Pairwise comparison (2-sided) of 3 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as a covariate.|ANCOVA|||||||0.311
72384642|NCT00785928|144276951|SUPERIORITY_OR_OTHER|||||||0.752||95.0||||Pairwise comparison (2-sided) of 10 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as a covariate.|ANCOVA|||||||0.752
72384643|NCT00785928|144276951|SUPERIORITY_OR_OTHER|||||||0.737||95.0||||Pairwise comparison (2-sided) of 30 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as a covariate.|ANCOVA|||||||0.737
72384644|NCT00785928|144276951|SUPERIORITY_OR_OTHER|||||||0.522||95.0||||Pairwise comparison (2-sided) of 60 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as a covariate.|ANCOVA|||||||0.522
72384645|NCT00785928|144276951|SUPERIORITY_OR_OTHER|||||||0.073||95.0||||Pairwise comparison (2-sided) of 120 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as a covariate.|ANCOVA|||||||0.073
72384646|NCT00785928|144276952|SUPERIORITY_OR_OTHER|||||||0.969||95.0||||Pairwise comparison (2-sided) of 1 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as a covariate.|ANCOVA|||||||0.969
72384647|NCT00785928|144276952|SUPERIORITY_OR_OTHER|||||||0.352||95.0||||Pairwise comparison (2-sided) of 3 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as a covariate.|ANCOVA|||||||0.352
72384648|NCT00785928|144276952|SUPERIORITY_OR_OTHER|||||||0.406||95.0||||Pairwise comparison (2-sided) of 10 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as a covariate.|ANCOVA|||||||0.406
72384649|NCT00785928|144276952|SUPERIORITY_OR_OTHER|||||||0.266||95.0||||Pairwise comparison (2-sided) of 30 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as a covariate.|ANCOVA|||||||0.266
72384650|NCT00785928|144276952|SUPERIORITY_OR_OTHER|||||||0.708||95.0||||Pairwise comparison (2-sided) of 60 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as a covariate.|ANCOVA|||||||0.708
72384651|NCT00785928|144276952|SUPERIORITY_OR_OTHER|||||||0.012||95.0||||Pairwise comparison (2-sided) of 120 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as a covariate.|ANCOVA|||||||0.012
72384652|NCT00785928|144276953|SUPERIORITY_OR_OTHER|||||||0.88||95.0||||Pairwise comparison (2-sided) of 1 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as a covariate.|ANCOVA|||||||0.880
72384653|NCT00785928|144276953|SUPERIORITY_OR_OTHER|||||||0.575||95.0||||Pairwise comparison (2-sided) of 3 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as a covariate.|ANCOVA|||||||0.575
72384654|NCT00785928|144276953|SUPERIORITY_OR_OTHER|||||||0.992||95.0||||Pairwise comparison (2-sided) of 10 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as a covariate.|ANCOVA|||||||0.992
72384655|NCT00785928|144276953|SUPERIORITY_OR_OTHER|||||||0.646||95.0||||Pairwise comparison (2-sided) of 30 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as a covariate.|ANCOVA|||||||0.646
72384656|NCT00785928|144276953|SUPERIORITY_OR_OTHER|||||||0.054||95.0||||Pairwise comparison (2-sided) of 60 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as a covariate.|ANCOVA|||||||0.054
72384657|NCT00785928|144276953|SUPERIORITY_OR_OTHER|||||||0.472||95.0||||Pairwise comparison (2-sided) of 120 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as a covariate.|ANCOVA|||||||0.472
72384658|NCT00785928|144276954|SUPERIORITY_OR_OTHER|||||||0.952||95.0||||Pairwise comparison (2-sided) of 1 mg LY2123799 versus placebo using ranked analysis of covariance (ANCOVA) with the standardized rank outcome variable, treatment as the fixed factor, and the standardized rank baseline value as a covariate.|ANCOVA|||||||0.952
72384659|NCT00785928|144276954|SUPERIORITY_OR_OTHER|||||||0.085||95.0||||Pairwise comparison (2-sided) of 3 mg LY2123799 versus placebo using ranked analysis of covariance (ANCOVA) with the standardized rank outcome variable, treatment as the fixed factor, and the standardized rank baseline value as a covariate.|ANCOVA|||||||0.085
72384660|NCT00785928|144276954|SUPERIORITY_OR_OTHER|||||||0.143||95.0||||Pairwise comparison (2-sided) of 10 mg LY2123799 versus placebo using ranked analysis of covariance (ANCOVA) with the standardized rank outcome variable, treatment as the fixed factor, and the standardized rank baseline value as a covariate.|ANCOVA|||||||0.143
72384661|NCT00785928|144276954|SUPERIORITY_OR_OTHER|||||||0.242||95.0||||Pairwise comparison (2-sided) of 30 mg LY2123799 versus placebo using ranked analysis of covariance (ANCOVA) with the standardized rank outcome variable, treatment as the fixed factor, and the standardized rank baseline value as a covariate.|ANCOVA|||||||0.242
72384662|NCT00785928|144276954|SUPERIORITY_OR_OTHER|||||||0.317||95.0||||Pairwise comparison (2-sided) of 60 mg LY2123799 versus placebo using ranked analysis of covariance (ANCOVA) with the standardized rank outcome variable, treatment as the fixed factor, and the standardized rank baseline value as a covariate.|ANCOVA|||||||0.317
72384663|NCT00785928|144276954|SUPERIORITY_OR_OTHER|||||||0.456||95.0||||Pairwise comparison (2-sided) of 120 mg LY2123799 versus placebo using ranked analysis of covariance (ANCOVA) with the standardized rank outcome variable, treatment as the fixed factor, and the standardized rank baseline value as a covariate.|ANCOVA|||||||0.456
72384664|NCT00785928|144276955|SUPERIORITY_OR_OTHER|||||||0.833||95.0||||Pairwise comparison (2-sided) of 1 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as the covariate.|ANCOVA|||||||0.833
72436822|NCT04001517|144386910|SUPERIORITY||Mean Difference (Net)|-0.45||||0.023|TWO_SIDED|95.0|-0.83|-0.06||Mixed model for repeated measures with baseline as a covariate. The p-value was not adjusted for multiple comparisons|Mixed Models Analysis||Comparison of combined neflamapimod dose groups vs. placebo. Negative values represents a better outcome with neflamapimod relative to placebo.|A secondary analysis was conducted comparing the combined neflamapimod dose groups vs. placebo.||-0.06|-0.83|0.023
72436823|NCT04001517|144386911|SUPERIORITY||||||>|0.2|||||||Mixed Models Analysis|||||||>0.2
72436824|NCT04001517|144386912|OTHER||Mean Difference (Net)|-1.53||||0.15|TWO_SIDED|95.0|-3.61|0.55|||Mixed Models Analysis|||||.55|-3.61|0.15
72436825|NCT04001517|144386912|SUPERIORITY||Mean Difference (Net)|-1.31||||0.077|TWO_SIDED|95.0|-5.03|2.34|||Mixed Models Analysis|||Comparison of combined neflamapimod groups (i.e., all neflamapimod) vs. placebo||2.34|-5.03|0.077
72384665|NCT00785928|144276955|SUPERIORITY_OR_OTHER|||||||0.826||95.0||||Pairwise comparison (2-sided) of 3 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as the covariate.|ANCOVA|||||||0.826
72384666|NCT00785928|144276955|SUPERIORITY_OR_OTHER|||||||0.091||95.0||||Pairwise comparison (2-sided) of 10 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as the covariate.|ANCOVA|||||||0.091
72384667|NCT00785928|144276955|SUPERIORITY_OR_OTHER|||||||0.127||95.0||||Pairwise comparison (2-sided) of 30 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as the covariate.|ANCOVA|||||||0.127
72384668|NCT00785928|144276955|SUPERIORITY_OR_OTHER|||||||0.243||95.0||||Pairwise comparison (2-sided) of 60 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as the covariate.|ANCOVA|||||||0.243
72384669|NCT00785928|144276955|SUPERIORITY_OR_OTHER|||||||0.037||95.0||||Pairwise comparison (2-sided) of 120 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as the covariate.|ANCOVA|||||||0.037
72384670|NCT00785928|144276956|SUPERIORITY_OR_OTHER|||||||0.562||95.0||||P-value for physical health component. Pairwise comparison (2-sided) of 1 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and baseline value as the covariate.|ANCOVA|||||||0.562
72384671|NCT00785928|144276956|SUPERIORITY_OR_OTHER|||||||0.539||95.0||||P-value for physical health component. Pairwise comparison (2-sided) of 3 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and baseline value as the covariate.|ANCOVA|||||||0.539
72384672|NCT00785928|144276956|SUPERIORITY_OR_OTHER|||||||0.304||95.0||||P-value for physical health component. Pairwise comparison (2-sided) of 10 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and baseline value as the covariate.|ANCOVA|||||||0.304
72436826|NCT04001517|144386913|SUPERIORITY||Mean Difference (Net)|0.32|||>|0.2|TWO_SIDED|95.0|-1.27|1.91|||Mixed Models Analysis||Comparison of change from baseline over course of study for NFMD 40mg TID vs. placebo.|||1.91|-1.27|>0.2
72558393|NCT01822119|144646434|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation|||||||<0.0001
72384673|NCT00785928|144276956|SUPERIORITY_OR_OTHER|||||||0.832||95.0||||P-value for physical health component. Pairwise comparison (2-sided) of 30 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and baseline value as the covariate.|ANCOVA|||||||0.832
72384674|NCT00785928|144276956|SUPERIORITY_OR_OTHER|||||||0.01||95.0||||P-value for physical health component. Pairwise comparison (2-sided) of 60 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and baseline value as the covariate.|ANCOVA|||||||0.010
72384675|NCT00785928|144276956|SUPERIORITY_OR_OTHER|||||||0.98||95.0||||P-value for physical health component. Pairwise comparison (2-sided) of 120 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and baseline value as the covariate.|ANCOVA|||||||0.980
72384676|NCT00785928|144276956|SUPERIORITY_OR_OTHER|||||||0.569||95.0||||P-value for mental health component. Pairwise comparison (2-sided) of 1 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and baseline value as the covariate.|ANCOVA|||||||0.569
72384677|NCT00785928|144276956|SUPERIORITY_OR_OTHER|||||||0.953||95.0||||P-value for mental health component. Pairwise comparison (2-sided) of 3 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and baseline value as the covariate.|ANCOVA|||||||0.953
72384678|NCT00785928|144276956|SUPERIORITY_OR_OTHER|||||||0.647||95.0||||P-value for mental health component. Pairwise comparison (2-sided) of 10 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and baseline value as the covariate.|ANCOVA|||||||0.647
72384679|NCT00785928|144276956|SUPERIORITY_OR_OTHER|||||||0.507||95.0||||P-value for mental health component. Pairwise comparison (2-sided) of 30 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and baseline value as the covariate.|ANCOVA|||||||0.507
72384680|NCT00785928|144276956|SUPERIORITY_OR_OTHER|||||||0.821||95.0||||P-value for mental health component. Pairwise comparison (2-sided) of 60 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and baseline value as the covariate.|ANCOVA|||||||0.821
72384681|NCT00785928|144276956|SUPERIORITY_OR_OTHER|||||||0.045||95.0||||P-value for mental health component. Pairwise comparison (2-sided) of 120 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and baseline value as the covariate.|ANCOVA|||||||0.045
72384682|NCT00785928|144276959|SUPERIORITY_OR_OTHER|||||||0.236||95.0||||Pairwise (2-sided) comparisons of 1 mg LY2127399 versus placebo using ranked analysis of covariance (ANCOVA) with the standardized rank outcome variable treatment as the fixed factor and the standardized rank baseline value as a covariate.|ANCOVA|||||||0.236
72384683|NCT00785928|144276959|SUPERIORITY_OR_OTHER|||||||0.038||95.0||||Pairwise (2-sided) comparisons of 3 mg LY2127399 versus placebo using ranked analysis of covariance (ANCOVA) with the standardized rank outcome variable treatment as the fixed factor and the standardized rank baseline value as a covariate.|ANCOVA|||||||0.038
72384684|NCT00785928|144276959|SUPERIORITY_OR_OTHER|||||||0.025||95.0||||Pairwise (2-sided) comparisons of 10 mg LY2127399 versus placebo using ranked analysis of covariance (ANCOVA) with the standardized rank outcome variable treatment as the fixed factor and the standardized rank baseline value as a covariate.|ANCOVA|||||||0.025
72384685|NCT00785928|144276959|SUPERIORITY_OR_OTHER|||||||0.005||95.0||||Pairwise (2-sided) comparisons of 30 mg LY2127399 versus placebo using ranked analysis of covariance (ANCOVA) with the standardized rank outcome variable treatment as the fixed factor and the standardized rank baseline value as a covariate.|ANCOVA|||||||0.005
72384686|NCT00785928|144276959|SUPERIORITY_OR_OTHER|||||||0.734||95.0||||Pairwise (2-sided) comparisons of 60 mg LY2127399 versus placebo using ranked analysis of covariance (ANCOVA) with the standardized rank outcome variable treatment as the fixed factor and the standardized rank baseline value as a covariate.|ANCOVA|||||||0.734
72384687|NCT00785928|144276959|SUPERIORITY_OR_OTHER|||||||0.035||95.0||||Pairwise (2-sided) comparisons of 120 mg LY2127399 versus placebo using ranked analysis of covariance (ANCOVA) with the standardized rank outcome variable treatment as the fixed factor and the standardized rank baseline value as a covariate.|ANCOVA|||||||0.035
72384688|NCT00785928|144276960|SUPERIORITY_OR_OTHER|||||||0.901||95.0||||P-value for IgG. Pairwise comparison (2-sided) of 1 mg LY2127399 versus placebo using ranked analysis of covariance (ANCOVA) with standardized rank outcome variable, treatment as the fixed factor, and standardized rank baseline value as a covariate.|ANCOVA|||||||0.901
72384689|NCT00785928|144276960|SUPERIORITY_OR_OTHER|||||||0.84||95.0||||P-value for IgG. Pairwise comparison (2-sided) of 3 mg LY2127399 versus placebo using ranked analysis of covariance (ANCOVA) with standardized rank outcome variable, treatment as the fixed factor, and standardized rank baseline value as a covariate.|ANCOVA|||||||0.840
72384690|NCT00785928|144276960|SUPERIORITY_OR_OTHER|||||||0.882||95.0||||P-value for IgG. Pairwise comparison (2-sided) of 10 mg LY2127399 versus placebo using ranked analysis of covariance (ANCOVA) with standardized rank outcome variable, treatment as the fixed factor, and standardized rank baseline value as a covariate.|ANCOVA|||||||0.882
72384691|NCT00785928|144276960|SUPERIORITY_OR_OTHER|||||||0.225||95.0||||P-value for IgG. Pairwise comparison (2-sided) of 30 mg LY2127399 versus placebo using ranked analysis of covariance (ANCOVA) with standardized rank outcome variable, treatment as the fixed factor, and standardized rank baseline value as a covariate.|ANCOVA|||||||0.225
72384692|NCT00785928|144276960|SUPERIORITY_OR_OTHER|||||||0.34||95.0||||P-value for IgG. Pairwise comparison (2-sided) of 60 mg LY2127399 versus placebo using ranked analysis of covariance (ANCOVA) with standardized rank outcome variable, treatment as the fixed factor, and standardized rank baseline value as a covariate.|ANCOVA|||||||0.340
72384693|NCT00785928|144276960|SUPERIORITY_OR_OTHER|||||||0.85||95.0||||P-value for IgG. Pairwise comparison (2-sided) of 120 mg LY2127399 versus placebo using ranked analysis of covariance (ANCOVA) with standardized rank outcome variable, treatment as fixed factor, and standardized rank baseline value as a covariate.|ANCOVA|||||||0.850
72436827|NCT04001517|144386914|OTHER||Mean Difference (Net)|-1.4||||0.024|TWO_SIDED|95.0|-2.6|-0.2|||Mixed Models Analysis||Mean difference for the comparison of 40 mg TID vs. placebo is reported.|||-0.2|-2.6|0.024
72494843|NCT00087646|144519005|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.0||||0.006|TWO_SIDED|95.0|1.21|3.31|||Cochran-Mantel-Haenszel|||Group A Vs Group D||3.31|1.21|0.0060
72494844|NCT00087646|144519006|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.98||||0.9228|TWO_SIDED|95.0|0.63|1.51|||Cochran-Mantel-Haenszel|||||1.51|0.63|0.9228
72494845|NCT00087646|144519007|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.22||||0.0006|TWO_SIDED|95.0|1.4|3.52|||Cochran-Mantel-Haenszel|||||3.52|1.40|0.0006
72494846|NCT00087646|144519008|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.64|||<|0.0001|TWO_SIDED|95.0|1.66|4.18|||Cochran-Mantel-Haenszel|||At Week 12||4.18|1.66|<.0001
72494847|NCT00087646|144519008|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.26||||0.1955|TWO_SIDED|95.0|0.89|1.79|||Cochran-Mantel-Haenszel|||At Week 24||1.79|0.89|0.1955
72494848|NCT00087646|144519008|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.36||||0.0883|TWO_SIDED|95.0|0.95|1.93|||Cochran-Mantel-Haenszel|||At Week 48||1.93|0.95|0.0883
72494849|NCT00087646|144519009|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.31|||<|0.0001|TWO_SIDED|95.0|1.67|3.19|||Cochran-Mantel-Haenszel|||Groups A vs Groups D (Week 12)||3.19|1.67|<.0001
72494850|NCT00087646|144519009|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.17||||0.3389|TWO_SIDED|95.0|0.85|1.6|||Cochran-Mantel-Haenszel|||Groups A vs Groups D (Week 24)||1.60|0.85|0.3389
72494851|NCT01331304|144519013|SUPERIORITY_OR_OTHER|||||||0.59||||||Because this study has co-primary outcomes (CGI-EI and NCAs), the analyses of the treatment effect in the two primary hypotheses each involved a two-tailed alpha-level of 0.025.|Mixed Models Analysis|||For the first co-primary aim, mixed-effects linear regression analyses compared the two intervention groups on the repeated assessments of the CGI-EI over 6 months.||||0.59
72494852|NCT01331304|144519014|SUPERIORITY_OR_OTHER|||||||0.118|||||||Wilcoxon (Mann-Whitney)|||For the second co-primary, patient monthly rates of NCAs (determined by dividing total number of NCAs during follow-up by the length of follow-up - to account for attrition and resulting differential exposure time) for treatment groups were compared using a Wilcoxon rank-sum test.||||0.118
72494853|NCT01331304|144519015|SUPERIORITY|||||||0.11||||||Analysis of this secondary outcome was not corrected for multiple comparisons. Therefore, the a priori threshold for statistical significance was set at 0.05|Mixed Models Analysis|||Mixed-effects linear regression analyses compared the two intervention groups on the repeated collection of measures relevant to calculation of the Framingham Risk Score over 6 months||||0.11
72494854|NCT01331304|144519016|SUPERIORITY|||||||0.7||||||Analysis of this secondary outcome was not corrected for multiple comparisons. Therefore, the a priori threshold for statistical significance was set at 0.05|Mixed Models Analysis|||Mixed-effects linear regression analyses compared the two intervention groups on the repeated assessment of the LIFE-RIFT over 6 months||||0.70
72494855|NCT02004873|144519028|SUPERIORITY_OR_OTHER||Kaplan-Meier survival probability (%)|96.0|||<|0.0001|TWO_SIDED|98.66|93.3|97.6||The threshold for statistical significance was 0.0067, determined by the pre-specified alpha spending function for the interim analysis.|z-test, 1-sided||"The major complication free rate (i.e. survival probability) was estimated using the Kaplan-Meier method.~The coverage level for the confidence interval was 98.66%, determined by the pre-specified alpha spending function for the interim analysis."|"Null hypothesis: Major complication free rate at 6 months post-implant is less than or equal to 83%.~Alternative hypothesis: Major complication free rate at 6 months post-implant is greater than 83%."||97.6|93.3|<0.0001
72494856|NCT02004873|144519029|SUPERIORITY_OR_OTHER||Percentage of subjects (%)|98.3|||<|0.0001|TWO_SIDED|98.66|95.4|99.6||The threshold for statistical significance was 0.0067, determined by the pre-specified alpha spending function for the interim analysis.|Exact Binomial test||The coverage level for confidence interval was 98.66%, determined by the pre-specified alpha spending function for the interim analysis.|"Null hypothesis: Percentage of subjects with an adequate pacing capture threshold at 6-months post-implant is less than or equal to 80%.~Alternative hypothesis: Percentage of subjects with an adequate pacing capture threshold at 6-months post-implant is greater than 80%."||99.6|95.4|<0.0001
72384694|NCT00785928|144276960|SUPERIORITY_OR_OTHER|||||||0.447||95.0||||P-value for IgM. Pairwise comparison (2-sided) of 1 mg LY2127399 versus placebo using ranked analysis of covariance (ANCOVA) with standardized rank outcome variable, treatment as the fixed factor, and standardized rank baseline value as a covariate.|ANCOVA|||||||0.447
72494857|NCT02004873|144519030|SUPERIORITY_OR_OTHER||Percentage of subjects (%)|99.6|||<|0.0001|TWO_SIDED|98.66|97.5|100.0||Holm adjustment for multiple comparisons for secondary objectives was used. The threshold for statistical significance was 0.0067, determined by the pre-specified alpha spending function for the interim analysis.|Exact Binomial test||The coverage level for confidence interval was 98.66%, determined by the pre-specified alpha spending function for the interim analysis.|"Null hypothesis: Percentage of subjects with VCMT within 0.5 Volts of auto decrement PCT at 6 months post-implant is less than or equal to 85%.~Alternative hypothesis: Percentage of subjects with VCMT within 0.5 Volts of auto decrement PCT at 6 months post-implant is greater than 85%."||100.0|97.5|<0.0001
72494858|NCT02004873|144519031|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin is 0.35. The Micra sensor indicated rate is considered proportional to the workload if the 90% CI for the Kay-Wilkoff slope parameter falls into \[0.65, 1.35\].|Slope|0.864|||<|0.001|TWO_SIDED|90.0|0.768|0.961||Holm adjustment for multiple comparisons for secondary objectives was used. Two One-sided Test (TOST) procedure was used at the 0.05 significance level.|t-test, 1 sided|Two One-sided Test (TOST)|A random effect linear regression model was used to assess if the Micra sensor-indicated rate was proportional to the workload using the Kay-Wilkoff model. The Kay-Wilkoff slope parameter was estimated along with its 90% CI.|Null hypothesis: Kay-Wilkoff slope parameter is \< 0.65 or \> 1.35 Alternative hypothesis: Kay-Wilkoff slope parameter is between 0.65 and 1.35||0.961|0.768|<0.001
72494859|NCT00866307|144519082|SUPERIORITY_OR_OTHER_LEGACY||Percentage|50.0|||||TWO_SIDED|90.0|35.6|64.4|||Agresti-Coull Confidence Interval|||Per protocol, percentage of high risk-High patients taking less than 49 weeks from day 1 of consolidation to day 1 of maintenance therapy is compared to a null fixed rate (\<=73%). A 90% two-sided Agresti-Coull confidence interval will be constructed and the lower bound examined. Will reject null if lower bound of confidence interval is above 73%.||64.4|35.6|
72494860|NCT00866307|144519083|SUPERIORITY_OR_OTHER_LEGACY||Percentage|53.3|||||TWO_SIDED|90.0|38.7|67.4|||Agresti-Coull Confidence Interval|||Per protocol, percentage receiving at least 8 doses is compared to a null fixed rate (\<=42%). A 90% two-sided Agresti-Coull confidence interval will be constructed. Will reject null if lower bound of confidence interval is above 42%.||67.4|38.7|
72494861|NCT01128829|144519090|SUPERIORITY_OR_OTHER|||||||0.025|||||||t-test, 2 sided|||Each subject served as their own control. We compared insulin concentrations when subjects consumed sucralose before a glucose load (experimental condition) with those on the day consumed water before a glucose load (control condition).||||0.025
72558394|NCT01822119|144646435|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Statistically significant changes with the same value at 500 to 4000Hz||||<0.0001
72558395|NCT01822119|144646435|SUPERIORITY_OR_OTHER|||||||0.0499|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Change at 6000Hz||||0.0499
72558396|NCT01822119|144646435|SUPERIORITY_OR_OTHER|||||||0.0632|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Change at 8000Hz||||0.0632
72558397|NCT01822119|144646436|SUPERIORITY_OR_OTHER|||||||0.39|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||||||0.39
72558398|NCT01822119|144646437|SUPERIORITY_OR_OTHER|||||||0.79|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||500Hz||||0.79
72558399|NCT01822119|144646437|SUPERIORITY_OR_OTHER|||||||0.26|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||1000Hz||||0.26
72558400|NCT01822119|144646437|SUPERIORITY_OR_OTHER|||||||0.24|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||2000Hz||||0.24
72558401|NCT01822119|144646437|SUPERIORITY_OR_OTHER|||||||0.83|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||3000Hz||||0.83
72558402|NCT01822119|144646437|SUPERIORITY_OR_OTHER|||||||0.026|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||4000Hz||||0.026
72558403|NCT01822119|144646437|SUPERIORITY_OR_OTHER|||||||0.0085|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||6000Hz||||0.0085
72558404|NCT01822119|144646437|SUPERIORITY_OR_OTHER|||||||0.13|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||8000Hz||||0.13
72558405|NCT01822119|144646438|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Statistically significant improvement with the same value at all presentation levels.||||<0.0001
72436828|NCT04001517|144386914|SUPERIORITY|Comparison of combined neflamapimod dose groups vs. placebo.|Mean Difference (Net)|-1.36||||0.044|TWO_SIDED|95.0|-2.69|-0.04|||Mixed Models Analysis|||||-0.04|-2.69|0.044
72436829|NCT02194933|144386928|SUPERIORITY_OR_OTHER|||||||0.3992||||||Test for Baseline vs. Week 6|Mixed Models Analysis|||||||0.3992
72436830|NCT02194933|144386929|SUPERIORITY_OR_OTHER|||||||0.0053||||||Test for Baseline vs. Week 6|Mixed Models Analysis|||||||0.0053
72436831|NCT02194933|144386931|SUPERIORITY_OR_OTHER|||||||0.1559|||||||Mixed Models Analysis|||||||0.1559
72436832|NCT02194933|144386931|SUPERIORITY_OR_OTHER|||||||0.6201|||||||Mixed Models Analysis|||||||0.6201
72558406|NCT01822119|144646439|SUPERIORITY_OR_OTHER|||||||0.55|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||50dB||||0.55
72558407|NCT01822119|144646439|SUPERIORITY_OR_OTHER|||||||0.72|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||60dB||||0.72
72558408|NCT01822119|144646439|SUPERIORITY_OR_OTHER|||||||0.28|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||80dB||||0.28
72558409|NCT01822119|144646440|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||||||<0.0001
72558410|NCT01822119|144646441|SUPERIORITY_OR_OTHER|||||||0.0092|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||||||0.0092
72558411|NCT01822119|144646442|SUPERIORITY_OR_OTHER|||||||0.59|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Aversiveness||||0.59
72436833|NCT02194933|144386932|SUPERIORITY_OR_OTHER|||||||0.1642|||||||Mixed Models Analysis|||||||0.1642
72436834|NCT02194933|144386932|SUPERIORITY_OR_OTHER|||||||0.1873|||||||Mixed Models Analysis|||||||0.1873
72436835|NCT02194933|144386935|SUPERIORITY_OR_OTHER|||||||0.2061|||||||Mixed Models Analysis|||||||0.2061
72436836|NCT02194933|144386935|SUPERIORITY_OR_OTHER|||||||0.1778|||||||Mixed Models Analysis|||||||0.1778
72436837|NCT02194933|144386936|SUPERIORITY_OR_OTHER|||||||0.4138|||||||Mixed Models Analysis|||||||0.4138
72436838|NCT02194933|144386936|SUPERIORITY_OR_OTHER|||||||0.3375|||||||Mixed Models Analysis|||||||0.3375
72436839|NCT02194933|144386939|SUPERIORITY_OR_OTHER|||||||0.8437|||||||Mixed Models Analysis|||||||0.8437
72436840|NCT02194933|144386939|SUPERIORITY_OR_OTHER|||||||0.8318|||||||Mixed Models Analysis|||||||0.8318
72436841|NCT02194933|144386940|SUPERIORITY_OR_OTHER|||||||0.6697|||||||Mixed Models Analysis|||||||0.6697
72558412|NCT01822119|144646442|SUPERIORITY_OR_OTHER|||||||0.71|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Ease of Communication||||0.71
72558413|NCT01822119|144646442|SUPERIORITY_OR_OTHER|||||||0.59|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Reverberation||||0.59
72558414|NCT01822119|144646442|SUPERIORITY_OR_OTHER|||||||0.4|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Background noise||||0.40
72558415|NCT01822119|144646442|SUPERIORITY_OR_OTHER|||||||0.5|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Global score||||0.50
72558416|NCT03031795|144646457|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance was set at \< 0.05 for each row comparison with no adjustment for multiple comparisons.|Wilcoxon rank sum test|||"A 2 point difference was used to power the study. This is consistent with previous definitions of a clinically meaningful reductions in pain and provides a visually meaningful change on the 0-10 numerical rating scale with anchors at every other point, for example moving from very severe (8) to severe pain (6) or from moderate pain (4) to mild pain (2)."||||< 0.05
72558417|NCT05604209|144646469|SUPERIORITY||Median log2 fold change|1.63|||<|0.001|TWO_SIDED|95.0|0.67|2.14|||Wilcoxon (Mann-Whitney)|Within-group log2 fold changes were statistically assessed using a two-sided exact Wilcoxon signed rank test.||The null hypothesis is that the median log2-fold change in magnitude of T-cell response to Mosaic-1 from baseline to day 35 within all vaccinees is zero.||2.14|0.67|<0.001
72558418|NCT05604209|144646469|SUPERIORITY||median log2 fold change|1.15||||0.008|TWO_SIDED|95.0|0.09|2.59|||Wilcoxon (Mann-Whitney)|Within-arm log2 fold changes were statistically assessed using a two-sided exact Wilcoxon signed rank test.||The null hypothesis is that the median log2-fold change in magnitude of T-cell response to Mosaic-1 from baseline to day 35 within the C62-M4 vaccinated arm is zero.||2.59|0.09|0.008
72558419|NCT05604209|144646469|SUPERIORITY||Median log2 fold change|1.66||||0.008|TWO_SIDED|95.0|0.93|4.59|||Wilcoxon (Mann-Whitney)|Within-am log2 fold changes were statistically assessed using a two-sided exact Wilcoxon signed rank test.||The null hypothesis is that the median log2-fold change in magnitude of T-cell response to Mosaic-1 from baseline to day 35 within the C1C62-M3M4 vaccinated arm is zero.||4.59|0.93|0.008
72618767|NCT01026038|144768112|SUPERIORITY_OR_OTHER||Percent Difference|0.0|||||TWO_SIDED|95.0|-3.7|6.5||||||Serotype 14: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 13vPnC/13vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/13vPnC/13vPnC along with exact 2-sided 95% CI.||6.5|-3.7|
72558420|NCT05604209|144646469|SUPERIORITY|||||||0.279|||||||Wilcoxon (Mann-Whitney)|Between-arm comparisons in log2 fold changes were statistically assessed using a two-sided exact Wilcoxon rank-sum test.||The contrast is the magnitude of the T-cell response to Mosaic-1 from baseline to day 35 in C62-M4 versus C1C62-M3M4.The null hypothesis is that he distributions of the T-cell response to Mosaic-1 from pre-vaccination to day 35 are the same between the two vaccinated arms.||||0.279
72558421|NCT05604209|144646470|SUPERIORITY||Median log2 fold change|1.66|||<|0.001|TWO_SIDED|95.0|1.09|2.33|||Wilcoxon (Mann-Whitney)|Within-group log2 fold changes were statistically assessed using a two-sided exact Wilcoxon signed rank test.||The null hypothesis is that the median log2-fold change in magnitude of T-cell response to Mosaic-2 from baseline to day 35 within all vaccinees is zero.||2.33|1.09|<0.001
72384695|NCT00785928|144276960|SUPERIORITY_OR_OTHER|||||||0.909||95.0||||P-value for IgM. Pairwise comparison (2-sided) of 3 mg LY2127399 versus placebo using ranked analysis of covariance (ANCOVA) with standardized rank outcome variable, treatment as the fixed factor, and standardized rank baseline value as a covariate.|ANCOVA|||||||0.909
72384696|NCT00785928|144276960|SUPERIORITY_OR_OTHER|||||||0.152||95.0||||P-value for IgM. Pairwise comparison (2-sided) of 10 mg LY2127399 versus placebo using ranked analysis of covariance (ANCOVA) with standardized rank outcome variable, treatment as the fixed factor, and standardized rank baseline value as a covariate.|ANCOVA|||||||0.152
72384697|NCT00785928|144276960|SUPERIORITY_OR_OTHER|||||||0.023||95.0||||P-value for IgM. Pairwise comparison (2-sided) of 30 mg LY2127399 versus placebo using ranked analysis of covariance (ANCOVA) with standardized rank outcome variable, treatment as the fixed factor, and standardized rank baseline value as a covariate.|ANCOVA|||||||0.023
72384698|NCT00785928|144276960|SUPERIORITY_OR_OTHER|||||||0.004||95.0||||P-value for IgM. Pairwise comparison (2-sided) of 60 mg LY2127399 versus placebo using ranked analysis of covariance (ANCOVA) with standardized rank outcome variable, treatment as the fixed factor, and standardized rank baseline value as a covariate.|ANCOVA|||||||0.004
72384699|NCT00785928|144276960|SUPERIORITY_OR_OTHER|||||||0.017||95.0||||P-value for IgM. Pairwise comparison (2-sided) of 120 mg LY2127399 versus placebo using ranked analysis of covariance (ANCOVA) with standardized rank outcome variable, treatment as fixed factor, and standardized rank baseline value as a covariate.|ANCOVA|||||||0.017
72436842|NCT02194933|144386940|SUPERIORITY_OR_OTHER|||||||0.8829|||||||Mixed Models Analysis|||||||0.8829
72436843|NCT02194933|144386941|SUPERIORITY_OR_OTHER|||||||0.2301|||||||Mixed Models Analysis|||||||0.2301
72436844|NCT02194933|144386941|SUPERIORITY_OR_OTHER|||||||0.0599|||||||Mixed Models Analysis|||||||0.0599
72436845|NCT02194933|144386942|SUPERIORITY_OR_OTHER|||||||0.1595|||||||Mixed Models Analysis|||||||0.1595
72436846|NCT02194933|144386942|SUPERIORITY_OR_OTHER|||||||0.1211|||||||Mixed Models Analysis|||||||0.1211
72436847|NCT02194933|144386943|SUPERIORITY_OR_OTHER|||||||0.1322|||||||Mixed Models Analysis|||||||0.1322
72436848|NCT02194933|144386943|SUPERIORITY_OR_OTHER|||||||0.2113|||||||Mixed Models Analysis|||||||0.2113
72618768|NCT01026038|144768112|SUPERIORITY_OR_OTHER||Percent Difference|0.0|||||TWO_SIDED|95.0|-6.7|6.5||||||Serotype 14: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 7vPnC/7vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/13vPnC/13vPnC along with exact 2-sided 95% CI.||6.5|-6.7|
72384700|NCT00785928|144276960|SUPERIORITY_OR_OTHER|||||||0.944||95.0||||P-value for IgA. Pairwise comparison (2-sided) of 1 mg LY2127399 versus placebo using ranked analysis of covariance (ANCOVA) with standardized rank outcome variable, treatment as the fixed factor, and standardized rank baseline value as a covariate.|ANCOVA|||||||0.944
72384701|NCT00785928|144276960|SUPERIORITY_OR_OTHER|||||||0.677||95.0||||P-value for IgA. Pairwise comparison (2-sided) of 3 mg LY2127399 versus placebo using ranked analysis of covariance (ANCOVA) with standardized rank outcome variable, treatment as the fixed factor, and standardized rank baseline value as a covariate.|ANCOVA|||||||0.677
72384702|NCT00785928|144276960|SUPERIORITY_OR_OTHER|||||||0.053||95.0||||P-value for IgA. Pairwise comparison (2-sided) of 10 mg LY2127399 versus placebo using ranked analysis of covariance (ANCOVA) with standardized rank outcome variable, treatment as the fixed factor, and standardized rank baseline value as a covariate.|ANCOVA|||||||0.053
72384703|NCT00785928|144276960|SUPERIORITY_OR_OTHER|||||||0.061||95.0||||P-value for IgA. Pairwise comparison (2-sided) of 30 mg LY2127399 versus placebo using ranked analysis of covariance (ANCOVA) with standardized rank outcome variable, treatment as the fixed factor, and standardized rank baseline value as a covariate.|ANCOVA|||||||0.061
72384704|NCT00785928|144276960|SUPERIORITY_OR_OTHER|||||||0.025||95.0||||P-value for IgA. Pairwise comparison (2-sided) of 60 mg LY2127399 versus placebo using ranked analysis of covariance (ANCOVA) with standardized rank outcome variable, treatment as the fixed factor, and standardized rank baseline value as a covariate.|ANCOVA|||||||0.025
72384705|NCT00785928|144276960|SUPERIORITY_OR_OTHER|||||||0.03||95.0||||P-value for IgA. Pairwise comparison (2-sided) of 120 mg LY2127399 versus placebo using ranked analysis of covariance (ANCOVA) with standardized rank outcome variable, treatment as fixed factor, and standardized rank baseline value as a covariate.|ANCOVA|||||||0.030
72436849|NCT02194933|144386944|SUPERIORITY_OR_OTHER|||||||0.0578|||||||Mixed Models Analysis|||||||0.0578
72436850|NCT02194933|144386944|SUPERIORITY_OR_OTHER|||||||0.0588|||||||Mixed Models Analysis|||||||0.0588
72436851|NCT02194933|144386945|SUPERIORITY_OR_OTHER|||||||0.1666|||||||Mixed Models Analysis|||||||0.1666
72436852|NCT02194933|144386945|SUPERIORITY_OR_OTHER|||||||0.767|||||||Mixed Models Analysis|||||||0.7670
72436853|NCT02194933|144386946|SUPERIORITY_OR_OTHER|||||||0.7178|||||||Mixed Models Analysis|||||||0.7178
72436854|NCT02194933|144386946|SUPERIORITY_OR_OTHER|||||||0.2336|||||||Mixed Models Analysis|||||||0.2336
72436855|NCT02194933|144386947|SUPERIORITY_OR_OTHER|||||||0.6558|||||||Mixed Models Analysis|||||||0.6558
72436856|NCT02194933|144386947|SUPERIORITY_OR_OTHER|||||||0.9058|||||||Mixed Models Analysis|||||||0.9058
72436857|NCT02194933|144386948|SUPERIORITY_OR_OTHER|||||||0.0078|||||||Mixed Models Analysis|||||||0.0078
72436858|NCT02194933|144386948|SUPERIORITY_OR_OTHER|||||||0.4272|||||||Mixed Models Analysis|||||||0.4272
72436859|NCT02045836|144386961|NON_INFERIORITY|Non Inferiority criterion used: Upper Limit (UL) of the 95% CI for each individual pneumococcal conjugate serotype Opsonophagocytic Assay (OPA) GMT ratio of the Control group over the Co-Ad group had to be below 2.|Adjusted GMT|1.03|||||TWO_SIDED|95.0|0.81|1.31|||ANCOVA|Ancova model: adjustment for baseline titre - pooled variance|Adjusted GMT ratio (Control group / Co-Ad group)|Adjusted ratios of GMTs between groups (Control group and Co-Ad group) for MOPA-1.||1.31|0.81|
72436860|NCT02045836|144386961|NON_INFERIORITY|Non Inferiority criterion used: Upper Limit (UL) of the 95% CI for each individual pneumococcal conjugate serotype Opsonophagocytic Assay (OPA) GMT ratio of the Control group over the Co-Ad group had to be below 2.|Adjusted GMT|0.96|||||TWO_SIDED|95.0|0.8|1.16|||ANCOVA|Ancova model: adjustment for baseline titre - pooled variance|Adjusted GMT ratio (Control group / Co-Ad group)|Adjusted ratios of GMTs between groups (Control group and Co-Ad group) for MOPA-3||1.16|0.8|
72436861|NCT02045836|144386961|NON_INFERIORITY|Non Inferiority criterion used: Upper Limit (UL) of the 95% CI for each individual pneumococcal conjugate serotype Opsonophagocytic Assay (OPA) GMT ratio of the Control group over the Co-Ad group had to be below 2.|Adjusted GMT|1.13|||||TWO_SIDED|95.0|0.92|1.4|||ANCOVA|Ancova model: adjustment for baseline titre - pooled variance|Adjusted GMT ratio (Control group / Co-Ad group)|Adjusted ratios of GMTs between groups (Control group and Co-Ad group) for MOPA-4||1.4|0.92|
72436862|NCT02045836|144386961|NON_INFERIORITY|Non Inferiority criterion used: Upper Limit (UL) of the 95% CI for each individual pneumococcal conjugate serotype Opsonophagocytic Assay (OPA) GMT ratio of the Control group over the Co-Ad group had to be below 2.|Adjusted GMT|0.96|||||TWO_SIDED|95.0|0.75|1.21|||ANCOVA|Ancova model: adjustment for baseline titre - pooled variance|Adjusted GMT ratio (Control group / Co-Ad group)|Adjusted ratios of GMTs between groups (Control group and Co-Ad group) for MOPA-5||1.21|0.75|
72436863|NCT02045836|144386961|NON_INFERIORITY|Non Inferiority criterion used: Upper Limit (UL) of the 95% CI for each individual pneumococcal conjugate serotype Opsonophagocytic Assay (OPA) GMT ratio of the Control group over the Co-Ad group had to be below 2.|Adjusted GMT|0.92|||||TWO_SIDED|95.0|0.73|1.16|||ANCOVA|Ancova model: adjustment for baseline titre - pooled variance|Adjusted GMT ratio (Control group / Co-Ad group)|Adjusted ratios of GMTs between groups (Control group and Co-Ad group) for MOPA-6B||1.16|0.73|
72436864|NCT02045836|144386961|NON_INFERIORITY|Non Inferiority criterion used: Upper Limit (UL) of the 95% CI for each individual pneumococcal conjugate serotype Opsonophagocytic Assay (OPA) GMT ratio of the Control group over the Co-Ad group had to be below 2.|Adjusted GMT|1.07|||||TWO_SIDED|95.0|0.89|1.29|||ANCOVA|Ancova model: adjustment for baseline titre - pooled variance|Adjusted GMT ratio (Control group / Co-Ad group)|Adjusted ratios of GMTs between groups (Control group and Co-Ad group) for MOPA-7F||1.29|0.89|
72494862|NCT01060059|144519107|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.95||||0.831|TWO_SIDED|95.0|0.62|1.46|||Regression, Logistic|If several variables had Spearman's rho \> 0.4 (for continuous) and Cramer's V \> 0.4 (for categorical covariates), only one was left in the model.||Logistic regression analysis was used to determine if Baseline Gender (Male vs. Female), was associated with treatment choice at baseline. Odds ratios were determined and if the odds ratio was greater than 1, it indicated it is more likely to initiate exenatide treatment. Covariates with more than 30% observations missing were omitted in this analysis. Missing values for remaining numeric covariates were replaced with means, and for categorical ones - with modes.||1.46|0.62|0.831
72494863|NCT01060059|144519107|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.14||||0.554|TWO_SIDED|95.0|0.74|1.76||Baseline Medical conditions (yes vs. no)|Regression, Logistic|||Logistic regression analysis was used to find factors associated with treatment choice at baseline. Covariates with more than 30% observations missing are omitted in this analysis. Weight was removed (high correlation with BMI) and also fasting blood glucose (lab value) was removed (high correlation with HbA1c). Missing values for remaining numeric covariates were replaced with means, and for categorical ones-with modes.||1.76|0.74|0.554
72494864|NCT01060059|144519107|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.21||||0.714|TWO_SIDED|95.0|0.43|3.42||Baseline gastrointestinal symptoms (yes vs. no)|Regression, Logistic|||Logistic regression analysis was used to find factors associated with treatment choice at baseline. Covariates with more than 30% observations missing are omitted in this analysis. Weight was removed (high correlation with BMI) and also fasting blood glucose (lab value) was removed (high correlation with HbA1c). Missing values for remaining numeric covariates were replaced with means, and for categorical ones-with modes.||3.42|0.43|0.714
72436865|NCT02045836|144386961|NON_INFERIORITY|Non Inferiority criterion used: Upper Limit (UL) of the 95% CI for each individual pneumococcal conjugate serotype Opsonophagocytic Assay (OPA) GMT ratio of the Control group over the Co-Ad group had to be below 2.|Adjusted GMT|0.97|||||TWO_SIDED|95.0|0.79|1.19|||ANCOVA|Ancova model: adjustment for baseline titre - pooled variance|Adjusted GMT ratio (Control group / Co-Ad group)|Adjusted ratios of GMTs between groups (Control group and Co-Ad group) for MOPA-9V||1.19|0.79|
72436866|NCT02045836|144386961|NON_INFERIORITY|Non Inferiority criterion used: Upper Limit (UL) of the 95% CI for each individual pneumococcal conjugate serotype Opsonophagocytic Assay (OPA) GMT ratio of the Control group over the Co-Ad group had to be below 2.|Adjusted GMT|0.97|||||TWO_SIDED|95.0|0.81|1.18|||ANCOVA|Ancova model: adjustment for baseline titre - pooled variance|Adjusted GMT ratio (Control group / Co-Ad group)|Adjusted ratios of GMTs between groups (Control group and Co-Ad group) for MOPA-14||1.18|0.81|
72494865|NCT01060059|144519108|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.69|||<|0.001|TWO_SIDED|95.0|0.6|0.78|||Regression, Logistic|If several variables had Spearman's rho \> 0.4 (for continuous) and Cramer's V \> 0.4 (for categorical covariates), only one was left in the model.||Logistic regression analysis was used to determine if Baseline HbA1c was 1% more, was it associated with treatment choice at baseline. Odds ratios were determined and if the odds ratio was greater than 1, it indicated it is more likely to initiate exenatide treatment. Covariates with more than 30% observations missing were omitted in this analysis. Missing values for remaining numeric covariates were replaced with means, and for categorical ones - with modes.||0.78|0.60|<0.001
72504626|NCT00112151|144540054|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.025|TWO_SIDED|||||A one-sided P-value of \<0.025 was used to define statistical significance|Regression, Linear|||As prespecified, the lower- and higher-range T groups were combined (any T). The primary analysis was conducted in the PRT groups and compared CS-PFP at 12 months with any T to placebo, adjusted for baseline CS-PFP score.||||<0.025
72504627|NCT00112151|144540054|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.025|TWO_SIDED|||||A one-sided P-value of \<0.025 was used to define statistical significance.|Regression, Linear|||As prespecified, the lower- and higher-range T groups were combined (any T). To address whether the effects of any T on physical function are the same without PRT, the analysis was also conducted in the No PRT groups, comparing CS-PFP at 12 months with any T to placebo, adjusted for baseline CS-PFP score.||||<0.025
72504628|NCT00112151|144540055|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05|TWO_SIDED||||||Regression, Linear|||As prespecified, the lower- and higher-range T groups were combined (Any T). The analysis compared change from baseline to 12 months in average upper body strength with any T to placebo in subjects assigned to PRT.||||<0.05
72436867|NCT02045836|144386961|NON_INFERIORITY|Non Inferiority criterion used: Upper Limit (UL) of the 95% CI for each individual pneumococcal conjugate serotype Opsonophagocytic Assay (OPA) GMT ratio of the Control group over the Co-Ad group had to be below 2.|Adjusted GMT|0.95|||||TWO_SIDED|95.0|0.77|1.16|||ANCOVA|Ancova model: adjustment for baseline titre - pooled variance|Adjusted GMT ratio (Control group / Co-Ad group)|Adjusted ratios of GMTs between groups (Control group and Co-Ad group) for MOPA-18C||1.16|0.77|
72436868|NCT02045836|144386961|NON_INFERIORITY|Non Inferiority criterion used: Upper Limit (UL) of the 95% CI for each individual pneumococcal conjugate serotype Opsonophagocytic Assay (OPA) GMT ratio of the Control group over the Co-Ad group had to be below 2.|Adjusted GMT|1.15|||||TWO_SIDED|95.0|0.95|1.4|||ANCOVA|Ancova model: adjustment for baseline titre - pooled variance|Adjusted GMT ratio (Control group / Co-Ad group)|Adjusted ratios of GMTs between groups (Control group and Co-Ad group) for MOPA-19A||1.4|0.95|
72436869|NCT02045836|144386961|NON_INFERIORITY|Non Inferiority criterion used: Upper Limit (UL) of the 95% CI for each individual pneumococcal conjugate serotype Opsonophagocytic Assay (OPA) GMT ratio of the Control group over the Co-Ad group had to be below 2.|Adjusted GMT|1.03|||||TWO_SIDED|95.0|0.84|1.25|||ANCOVA|Ancova model: adjustment for baseline titre - pooled variance|Adjusted GMT ratio (Control group / Co-Ad group)|Adjusted ratios of GMTs between groups (Control group and Co-Ad group) for MOPA-19F||1.25|0.84|
72436870|NCT02045836|144386961|NON_INFERIORITY|Non Inferiority criterion used: Upper Limit (UL) of the 95% CI for each individual pneumococcal conjugate serotype Opsonophagocytic Assay (OPA) GMT ratio of the Control group over the Co-Ad group had to be below 2.|Adjusted GMT|0.89|||||TWO_SIDED|95.0|0.7|1.12|||ANCOVA|Ancova model: adjustment for baseline titre - pooled variance|Adjusted GMT ratio (Control group / Co-Ad group)|Adjusted ratios of GMTs between groups (Control group and Co-Ad group) for MOPA-23F||1.12|0.7|
72436871|NCT02045836|144386962|NON_INFERIORITY|Non Inferiority criterion used: UL of the 95% CI for the anti-gE antibodies GMC ratio between the Control group and the Co-Ad group had to be below 1.5|Adjusted GMC|1.02|||||TWO_SIDED|95.0|0.93|1.11|||ANCOVA|Ancova model: adjustment for baseline concentration and age - pooled variance|Adjusted ratios of GMCs between groups (Control group and Co-Ad group)|Adjusted ratios of GMCs between groups (Control group and Co-Ad group) for anti-gE antibody ELISA concentrations||1.11|0.93|
72436872|NCT03399370|144387014|SUPERIORITY|LS Mean Difference (95% CI) from Placebo|Mean Difference (Final Values)|-57.64|||<|0.0001|TWO_SIDED|95.0|-60.86|-54.43||The a priori threshold for statistical significance was \<0.05|ANCOVA||Represents the least squares mean difference from Placebo|||-54.43|-60.86|<.0001
72436873|NCT03399370|144387015|SUPERIORITY|LS Mean Difference (95% CI) from Placebo|Mean Difference (Final Values)|-53.78|||<|0.0001|TWO_SIDED|95.0|-56.23|-51.33||The a priori threshold for statistical significance was \<0.05|ANCOVA||Represents the least squares mean difference from Placebo|||-51.33|-56.23|<0.0001
72436874|NCT03399370|144387016|SUPERIORITY|LS Mean Difference (95% CI) from Placebo|Mean Difference (Final Values)|-54.12|||<|0.0001|TWO_SIDED|95.0|-57.37|-50.88||The a priori threshold for statistical significance was \<0.05|ANCOVA||Represents the least squares mean difference from Placebo|||-50.88|-57.37|<0.0001
72436875|NCT03399370|144387017|SUPERIORITY||Mean Difference (Final Values)|-53.28|||<|0.0001|TWO_SIDED|95.0|-55.75|-50.8||The a priori threshold for statistical significance was \<0.05|ANCOVA||Represents the least squares mean difference from Placebo|||-50.80|-55.75|<0.0001
72436876|NCT03399370|144387018|SUPERIORITY||Mean Difference (Final Values)|-83.8|||<|0.0001|TWO_SIDED|95.0|-89.25|-77.34||The a priori threshold for statistical significance was \<0.05|ANCOVA||Represents the least squares mean difference from Placebo|||-77.34|-89.25|<0.0001
72436877|NCT03399370|144387019|SUPERIORITY||Mean Difference (Final Values)|-33.13|||<|0.0001|TWO_SIDED|95.0|-35.3|-30.97||The a priori threshold for statistical significance was \<0.05|ANCOVA||Represents the least squares mean difference from Placebo|||-30.97|-35.30|<0.0001
72436878|NCT03399370|144387020|SUPERIORITY||Mean Difference (Final Values)|-43.09|||<|0.0001|TWO_SIDED|95.0|-45.5|-40.67||The a priori threshold for statistical significance was \<0.05|ANCOVA||Represents the least squares mean difference from Placebo|||-40.67|-45.50|<.0001
72436879|NCT03399370|144387021|SUPERIORITY||Mean Difference (Final Values)|-47.36|||<|0.0001|TWO_SIDED|95.0|-50.25|-44.47||The a priori threshold for statistical significance was \<0.05|ANCOVA||Represents the least squares mean difference from Placebo|||-44.47|-50.25|<0.0001
72436880|NCT02498769|144387022|OTHER||Hazard Ratio (HR)|0.69||||0.18|TWO_SIDED|95.0|0.41|1.19|||Regression, Cox|||||1.19|0.41|0.18
72436881|NCT02498769|144387023|OTHER||Odds Ratio (OR)|0.63||||0.19|TWO_SIDED|95.0|0.31|1.27|||Regression, Logistic|||||1.27|0.31|0.19
72436882|NCT02498769|144387024|OTHER|||||||0.16|||||||Wilcoxon (Mann-Whitney)|||ICU length of stay hours||||.16
72436883|NCT02498769|144387024|OTHER|||||||0.51|||||||Wilcoxon (Mann-Whitney)|||Hospital LOS||||.51
72436884|NCT02498769|144387025|OTHER|||||||0.97|||||||Chi-squared|||||||.97
72436885|NCT02739035|144387026|SUPERIORITY|A difference of 10 degrees in total mean range of motion between the control and the treatment group was considered a clinically significant improvement.||||||0.23||||||Using a standard alpha value of 0.05, p values below 0.05 were considered statistically significant.|t-test, 2 sided|||"Outcomes were compared between the two study groups using two-sample t-tests. T-tests were two-sided and the standard alpha value of 0.05 was the threshold for statistical significance.~The null hypothesis was that there were no significant differences between control group of MUA alone and the treatment group of MUA with dexamethasone and celecoxib."||||0.23
72436886|NCT02739035|144387027|SUPERIORITY|A difference of 10 degrees in total mean range of motion (ROM) between the control and the treatment group was considered a clinically significant improvement. To detect this difference, a previous study's mean and standard deviation were referenced in order to predict the variation of results. 54 patients per arm were required to have 90% power with a two-sided t-test and a type I error rate of 5%. 130 patients were targeted for recruitment to account for up to a 20% dropout rate.||||||0.81||||||Using a standard alpha value of 0.05, p values below 0.05 were considered statistically significant.|t-test, 2 sided|||"Outcomes were compared between the two study groups using two-sample t-tests. T-tests were two-sided and the standard alpha value of 0.05 was the threshold for statistical significance.~The null hypothesis was that there were no significant differences between control group of MUA alone and the treatment group of MUA with dexamethasone and celecoxib."||||0.81
72504629|NCT00112151|144540055|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05|TWO_SIDED||||||Regression, Linear|||As prespecified, the lower- and higher-range T groups were combined (Any T). The analysis compared change from baseline to 12 months in average upper body strength with any T to placebo in subjects assigned to no PRT.||||<0.05
72558422|NCT05604209|144646470|SUPERIORITY||Median log2 fold change|1.79||||0.008|TWO_SIDED|95.0|0.59|3.4|||Wilcoxon (Mann-Whitney)|Within-arm log2 fold changes were statistically assessed using a two-sided exact Wilcoxon signed rank test.||The null hypothesis is that the median log2-fold change in magnitude of T-cell response to Mosaic-2 from baseline to day 35 within the C62-M4 vaccinated arm is zero.||3.40|0.59|0.008
72436887|NCT05819190|144387046|SUPERIORITY|||||||0.0192|||||||Wilcoxon (Mann-Whitney)|||Comparison of the mean AUC of WURSS-21 scores assessed during the first 8 days of the study between both groups - FAS set||||0.0192
72436888|NCT05819190|144387047|SUPERIORITY|||||||0.0296|||||||Wilcoxon (Mann-Whitney)|||Comparison of the mean AUC of WURSS-21 scores assessed during the first 8 days of the study between both groups - PP set||||0.0296
72436889|NCT05819190|144387048|SUPERIORITY|||||||0.0085|||||||Wilcoxon (Mann-Whitney)|||||||0.0085
72558423|NCT05604209|144646470|SUPERIORITY||Median log2 fold change|1.66||||0.008|TWO_SIDED|95.0|0.94|3.09|||Wilcoxon (Mann-Whitney)|Within-arm log2 fold changes were statistically assessed using a two-sided exact Wilcoxon signed rank test.||The null hypothesis is that the median log2-fold change in magnitude of T-cell response to Mosaic-2 from baseline to day 35 within the C1C62-M3M4 vaccinated arm is zero.||3.09|0.94|0.008
72494866|NCT01060059|144519109|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.98||||0.055|TWO_SIDED|95.0|0.96|1.0|||Regression, Logistic|If several variables had Spearman's rho \> 0.4 (for continuous) and Cramer's V \> 0.4 (for categorical covariates), only one was left in the model.||Logistic regression analysis was used to determine if longer duration of diabetes was associated with treatment choice at baseline. Odds ratios were determined and if the odds ratio was greater than 1, it indicated it is more likely to initiate exenatide treatment. Covariates with more than 30% observations missing were omitted in this analysis. Missing values for remaining numeric covariates were replaced with means, and for categorical ones - with modes.||1.00|0.96|0.055
72436890|NCT05819190|144387049|SUPERIORITY|||||||0.0081|||||||Wilcoxon (Mann-Whitney)|||||||0.0081
72436891|NCT05819190|144387050|SUPERIORITY|||||||0.005|||||||Wilcoxon (Mann-Whitney)|||||||0.0050
72436892|NCT05819190|144387051|SUPERIORITY|||||||0.0107|||||||Wilcoxon (Mann-Whitney)|||||||0.0107
72436893|NCT05819190|144387052|SUPERIORITY|||||||0.0424|||||||Wilcoxon (Mann-Whitney)|||||||0.0424
72436894|NCT05819190|144387053|SUPERIORITY|||||||0.43||||||one sided test|Wilcoxon (Mann-Whitney)|||0.05 global significance level (type I error rate)||||0.430
72436895|NCT05819190|144387054|SUPERIORITY|||||||0.339|||||||Wilcoxon (Mann-Whitney)|one sided test||0.05 global significance level (type I error rate)||||0.339
72558424|NCT05604209|144646470|SUPERIORITY|||||||0.878|||||||Wilcoxon (Mann-Whitney)|Between-arm comparisons in log2 fold changes were statistically assessed using a two-sided exact Wilcoxon rank-sum test.||The contrast is the magnitude of the T-cell response to Mosaic-2 from baseline to day 35 in C62-M4 versus C1C62-M3M4.The null hypothesis is that he distributions of the T-cell response to Mosaic-2 from pre-vaccination to day 35 are the same between the two vaccinated arms.||||0.878
72436896|NCT05819190|144387055|SUPERIORITY|||||||0.704|||||||Wilcoxon (Mann-Whitney)|one sided test||0.05 global significance level (type I error rate)||||0.704
72436897|NCT05819190|144387056|SUPERIORITY|||||||0.298|||||||Wilcoxon (Mann-Whitney)|One sided test||0.05 global significance level (type I error rate)||||0.298
72436898|NCT05819190|144387057|SUPERIORITY|||||||0.906|||||||Wilcoxon (Mann-Whitney)|one sided test||0.05 global significance level (type I error rate)||||0.906
72436899|NCT05819190|144387058|SUPERIORITY|||||||0.582|||||||Wilcoxon (Mann-Whitney)|one sided test||0.05 global significance level (type I error rate)||||0.582
72436900|NCT05819190|144387059|SUPERIORITY|||||||0.743|||||||Wilcoxon (Mann-Whitney)|one sided test||0.05 global significance level (type I error rate)||||0.743
72436901|NCT05819190|144387060|SUPERIORITY|||||||0.605|||||||Fisher Exact|One sided test||0.05 global significance level (type I error rate)||||0.605
72494867|NCT01060059|144519110|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.97|||<|0.001|TWO_SIDED|95.0|0.95|0.99|||Regression, Logistic|If several variables had Spearman's rho \> 0.4 (for continuous) and Cramer's V \> 0.4 (for categorical covariates), only one was left in the model.||Logistic regression analysis was used to determine if older age (1 year older), was associated with treatment choice at baseline. Odds ratios were determined and if the odds ratio was greater than 1, it indicated it is more likely to initiate exenatide treatment. Covariates with more than 30% observations missing were omitted in this analysis. Missing values for remaining numeric covariates were replaced with means, and for categorical ones - with modes.||0.99|0.95|<0.001
72436902|NCT05819190|144387061|SUPERIORITY|||||||1|||||||Fisher Exact|one sided test||0.05 global significance level (type I error rate)||||1.000
72436903|NCT05819190|144387062|SUPERIORITY|||||||0.988|||||||Fisher Exact|One sided test||0.05 global significance level (type I error rate)||||0.988
72436904|NCT05819190|144387063|SUPERIORITY|||||||0.483|||||||Fisher Exact|one sided test||0.05 global significance level (type I error rate)||||0.483
72436905|NCT02517307|144387064|OTHER|||||||0.136|||||||Mixed Models Analysis|||We compared the effects of intralipid on Rd in controls subjects versus subjects with a FAOD by mixed-effect models. Factors were group (control or FAOD) treatment (glycerol or intralipid) and the interaction of those factors. The hypothesis was intralipid would decrease Rd in controls but not in subjects with an FAOD.||||0.136
72436906|NCT02517307|144387065|OTHER|We analyzed the data with a mixed model looking at the effect of group (control vs FAOD) and treatment (glycerol vs intralipid) and their interaction.||||||0.011|||||||Mixed Models Analysis|||We tested if intralipid did not suppress endogenous glucose production or Ra as much as glycerol in controls compared to subjects with an FAOD.||||0.011
72436907|NCT01212757|144387127|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|13.4||||0.006|TWO_SIDED|95.0|4.0|22.7|||Cochran-Mantel-Haenszel|2-sided p-value is based on the Cochran-Mantel-Haenszel (CMH) test adjusting for baseline disease modifying antirheumatic drug (DMARD) use.|Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the CMH weights. The 2-sided 95% confidence interval (CI) is based on a normal approximation to the weighted average.|In order to maintain the Type 1 error at the 0.05 significance level, the Hochberg procedure was to be used. The results of the endpoint were to be considered statistically significant if both the 30 mg apremilast dose versus placebo comparison and the 20 mg versus placebo comparison were statistically significant at the 0.05 significance level, or one of the comparisons was statistically significant at the 0.025 level.||22.7|4.0|0.0060
72558425|NCT05604209|144646471|SUPERIORITY||Median log2 fold change|1.47|||<|0.001|TWO_SIDED|95.0|0.54|2.63|||Wilcoxon (Mann-Whitney)|Within-group log2 fold changes were statistically assessed using a two-sided exact Wilcoxon signed rank test||The null hypothesis is that the median log2-fold change in magnitude of T-cell response to Mosaic-1 from baseline to day 42 within all vaccinees is zero.||2.63|0.54|<0.001
72384706|NCT05021081|144276962|OTHER|The least-square means (i.e., adjusted means) of photopic contrast sensitivity at 6 cpd was estimated separately under conditions with glare source and without glare source. This endpoint was not statistically tested, and consequentially statistical interferences was not made.|Least-square Mean Difference|-0.45|STANDARD_ERROR_OF_MEAN|0.114|||TWO_SIDED|95.0|-0.7|-0.21|||Linear Mixed Model|Kenward and Roger method was used for denominator degrees of freedom.|Least-square Mean difference was calculated as With glare minus Without glare|The sample size was chosen based on resources in conjunction, subject matter experts, and any available literature. To help ensure the glare source intensity, a small pilot investigation per the ANSI Z80.12-2007 standard was interpreted to be about 20 subjects to complete Phase 1, which should be sufficient to evaluate the mean photopic contrast sensitivity with and without the glare source.||-0.21|-0.70|
72384707|NCT05021081|144276963|OTHER|The least-square means (i.e., adjusted means) of mesopic contrast sensitivity at 6 cpd was estimated separately under conditions with glare source and without glare source. This endpoint was not statistically tested, and consequentially statistical interferences was not made.|Least-square Mean Difference|-0.58|STANDARD_ERROR_OF_MEAN|0.102|||TWO_SIDED|95.0|-0.81|-0.36|||Linear Mixed Model|Kenward and Roger method was used for denominator degrees of freedom.|Least-square Mean difference was calculated as With glare minus Without glare|The sample size was chosen based on resources in conjunction, subject matter experts, and any available literature. To help ensure the glare source intensity, a small pilot investigation per the ANSI Z80.12-2007 standard was interpreted to be about 20 subjects to complete Phase 1, which should be sufficient to evaluate the mean mesopic contrast sensitivity with and without the glare source.||-0.36|-0.81|
72384708|NCT05021081|144276964|SUPERIORITY|Superiority was declared if the upper bound of the 2-sided 95% confidence interval of the mean difference was below 0.|Least-square Mean Difference|0.019|STANDARD_ERROR_OF_MEAN|0.024|||TWO_SIDED|95.0|-0.029|0.068|||Linear Mixed Model|Kenward and Roger method was used for denominator degrees of freedom.|Least-square Mean difference was calculated as Test minus Control|Given no historical data is available, the sample size was not determined based on any empirical sample size calculation. A power analysis was conducted using a paired sample t-test (exact method) with a 2-sided type I error rate 0.05 to estimate statistical power based on different assumptions. The power analysis showed that the statistical power for testing superiority would be approximately 80% or higher with the effect size of -0.05 (mean difference: Test minus Control).||0.068|-0.029|
72384709|NCT00369122|144276967|OTHER||||||||||||||||||Based on a report by Laciano, et al. an SAE rate of 5% and AE rate of 35% were considered tolerable and an SAE rate \>=20% and AE rate \>=55% excessive. If there were \>=6 pts with SAES or \>=22 pts with AEs then the treatment would be rejected. This study design provides alpha of 0.05 and power of 90%.|||
72384710|NCT00631696|144276972|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|A non-inferiority margin of 20% was used to test the hypothesis. The null hypothesis is that the difference (PGB - PBO) in the proportion of participants with ≥50% reduction in sperm concentration is ≥20% and the alternative hypothesis is that the difference in proportion of participant with ≥50% reduction in sperm concentration is \<20%.|percentage difference|6.0|||||TWO_SIDED|95.0|-2.29|14.3|||Confidence Interval Approach||The confidence interval was based on asymptotic normal distribution.|Study powered to show non-inferiority (NI) of pregabalin (PGB) to placebo (PBO) on the percentage of participants (N) with a ≥50% reduction in MSC from Bsl to end of washout (Week (Wk) 26, or last assessment on or after Wk 12 if Wk 26 not done). NI to be declared if upper bound of 95% CI for difference between PGB and PBO not \>20%. Assuming proportion of N with 50% reduction to be 6% for both groups, sample size N=65 per group would provide \>90% power to show NI of PGB to PBO.||14.30|-2.29|
72384711|NCT00631696|144276973|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.12||||0.3462|TWO_SIDED|95.0|-0.385|0.136||p-value from analysis of covariance (ANCOVA) with treatment and center as main effects and baseline value as covariate in the model.|ANCOVA||Least Squares Mean (LS Mean) and 95% CI from ANCOVA with treatment and center as main effects and baseline value as covariate in the model. LS Mean Difference calculated as (Pregabalin - Placebo).|||0.136|-0.385|0.3462
72384712|NCT00631696|144276974|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.13||||0.3652|TWO_SIDED|95.0|-0.42|0.156||p-value from analysis of covariance (ANCOVA) with treatment and center as main effects and baseline value as covariate in the model.|ANCOVA||Least Squares Mean (LS Mean) and 95% CI from ANCOVA with treatment and center as main effects and baseline value as covariate in the model. LS Mean Difference calculated as (Pregabalin - Placebo).|||0.156|-0.420|0.3652
72384713|NCT00631696|144276975|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.2||||0.1204|TWO_SIDED|95.0|-0.464|0.054||p-value from analysis of covariance (ANCOVA) with treatment and center as main effects and baseline value as covariate in the model.|ANCOVA||Least Squares Mean (LS Mean) and 95% CI from ANCOVA with treatment and center as main effects and baseline value as covariate in the model. LS Mean Difference calculated as (Pregabalin - Placebo).|||0.054|-0.464|0.1204
72384714|NCT00631696|144276976|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|24.65||||0.2875|TWO_SIDED|95.0|-20.999|70.302||p-value from analysis of covariance (ANCOVA) with treatment and center as main effects and baseline value as covariate in the model.|ANCOVA||Least Squares Mean (LS Mean) and 95% CI from ANCOVA with treatment and center as main effects and baseline value as covariate in the model. LS Mean Difference calculated as (Pregabalin - Placebo).|||70.302|-20.999|0.2875
72494868|NCT01060059|144519111|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.19|||<|0.001|TWO_SIDED|95.0|1.15|1.23|||Regression, Logistic|If several variables had Spearman's rho \> 0.4 (for continuous) and Cramer's V \> 0.4 (for categorical covariates), only one was left in the model.||Logistic regression analysis was used to determine if higher BMI (1 kg/m\^2 higher) was associated with treatment choice at baseline. Odds ratios were determined and if the odds ratio was greater than 1, it indicated it is more likely to initiate exenatide treatment. Covariates with more than 30% observations missing were omitted in this analysis. Missing values for remaining numeric covariates were replaced with means, and for categorical ones - with modes.||1.23|1.15|<0.001
72384715|NCT00631696|144276977|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|32.93||||0.1699|TWO_SIDED|95.0|-14.292|80.158||p-value from analysis of covariance (ANCOVA) with treatment and center as main effects and baseline value as covariate in the model.|ANCOVA||Least Squares Mean (LS Mean) and 95% CI from ANCOVA with treatment and center as main effects and baseline value as covariate in the model. LS Mean Difference calculated as (Pregabalin - Placebo).|||80.158|-14.292|0.1699
72384716|NCT00631696|144276978|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-6.12||||0.7958|TWO_SIDED|95.0|-52.804|40.558||p-value from analysis of covariance (ANCOVA) with treatment and center as main effects and baseline value as covariate in the model.|ANCOVA||Least Squares Mean (LS Mean) and 95% CI from ANCOVA with treatment and center as main effects and baseline value as covariate in the model. LS Mean Difference calculated as (Pregabalin - Placebo).|||40.558|-52.804|0.7958
72384717|NCT00631696|144276979|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.08||||0.4094|TWO_SIDED|95.0|-3.645|1.494||p-value from analysis of covariance (ANCOVA) with treatment and center as main effects and baseline value as covariate in the model.|ANCOVA||Least Squares Mean (LS Mean) and 95% CI from ANCOVA with treatment and center as main effects and baseline value as covariate in the model. LS Mean Difference calculated as (Pregabalin - Placebo).|||1.494|-3.645|0.4094
72384718|NCT00631696|144276980|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.15||||0.9064|TWO_SIDED|95.0|-2.649|2.352||p-value from analysis of covariance (ANCOVA) with treatment and center as main effects and baseline value as covariate in the model.|ANCOVA||Least Squares Mean (LS Mean) and 95% CI from ANCOVA with treatment and center as main effects and baseline value as covariate in the model. LS Mean Difference calculated as (Pregabalin - Placebo).|||2.352|-2.649|0.9064
72384719|NCT00631696|144276981|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.86||||0.4666|TWO_SIDED|95.0|-3.207|1.477||p-value from analysis of covariance (ANCOVA) with treatment and center as main effects and baseline value as covariate in the model.|ANCOVA||Least Squares Mean (LS Mean) and 95% CI from ANCOVA with treatment and center as main effects and baseline value as covariate in the model. LS Mean Difference calculated as (Pregabalin - Placebo).|||1.477|-3.207|0.4666
72384720|NCT03387683|144276989|OTHER||Difference in LSM|0.31121|STANDARD_ERROR_OF_MEAN|0.46184||0.504|TWO_SIDED|95.0|-0.619|1.24141||Statistical significance was inferred at a (2-sided) 0.05 level.|ANCOVA|The LSM estimate and corresponding p-value were obtained from a linear model with treatment and baseline value of the endpoint as covariates.||Difference in LSM (Placebo-Dapagliflozin 10 mg)||1.24141|-0.61900|0.504
72384721|NCT03387683|144276990|OTHER||Difference in LSM|1.74969|STANDARD_ERROR_OF_MEAN|2.18363||0.427|TWO_SIDED|95.0|-2.64837|6.14775||Statistical significance was inferred at a (2-sided) 0.05 level.|ANCOVA|The LSM estimate and corresponding p-value were obtained from a linear model with treatment and baseline value of the endpoint as covariates.||Difference in LSM (Placebo - Dapagliflozin 10 mg)||6.14775|-2.64837|0.427
72384722|NCT01950169|144277008|SUPERIORITY|||||||0.05|||||||ANCOVA|Covariates used were age, sex, total mass, and baseline BMD. Data were reported using complete-cases analysis and intention-to-treat (ITT) analysis.||||||0.05
72384723|NCT01950169|144277009|SUPERIORITY|||||||0.05|||||||ANCOVA|Covariates used were age, sex, total mass, and baseline BMD. Data were reported using complete-cases analysis and intention-to-treat (ITT) analysis.||||||0.05
72384724|NCT01950169|144277010|SUPERIORITY|||||||0.05|||||||ANCOVA|The analyses included exposure measures treatment groups and sex as fixed factors. Age and baseline values for FFMI, FMI were included as covariates.||||||0.05
72384725|NCT01680887|144277042|SUPERIORITY|||||||0.403|||||||Chi-squared|||||||.403
72384726|NCT02664610|144277053|SUPERIORITY|||||||0.6|||||||t-test, 2 sided|||||||0.60
72384727|NCT02664610|144277054|SUPERIORITY|||||||0.79|||||||t-test, 2 sided|||||||0.79
72384728|NCT02927262|144277130|SUPERIORITY||Hazard Ratio (HR)|0.738||||0.163|TWO_SIDED|95.0|0.407|1.336|||Log Rank||HR \& 95% CI are based on CHM. Assuming proportional hazards, HR \< 1 indicates a reduction in hazard rate in favor of gilteritinib arm. Stratification factors:age, geographic region, presence of MRD at screening, use of FLT3 inhibiting agents per IRT.|||1.336|0.407|0.163
72384729|NCT02927262|144277131|SUPERIORITY||Hazard Ratio (HR)|1.13||||0.627||95.0|0.54|2.364|||Log Rank||HR \& 95%CI are based on CHM. Assuming proportional hazards, HR \< 1 indicates a reduction in hazard rate in favor of gilteritinib arm. Stratification factors: age, geographic region, presence of MRD at screening, use of FLT3 inhibiting agents per IRT.|||2.364|0.540|0.627
72384730|NCT02927262|144277132|SUPERIORITY||Hazard Ratio (HR)|0.862||||0.296|TWO_SIDED|95.0|0.51|1.455|||Log Rank||HR \& 95%CI are based on CHM. Assuming proportional hazards, HR \< 1 indicates a reduction in hazard rate in favor of gilteritinib arm. Stratification factors: age, geographic region, presence of MRD at screening, use of FLT3 inhibiting agents per IRT.|||1.455|0.510|0.296
72384731|NCT02927262|144277133|SUPERIORITY|||||||0.97||||||2-sided P-value from analysis of covariance (ANCOVA) including treatment, age group, geographic region and use of FLT3-inhibiting agents per IRT as fixed factors and baseline score as covariate.|ANCOVA|||Month 3||||0.970
72384732|NCT02927262|144277133|SUPERIORITY|||||||0.415||||||2-sided P-value from ANCOVA including treatment, age group, geographic region and use of FLT3-inhibiting agents per IRT as fixed factors and baseline score as covariate.|ANCOVA|||Month 6||||0.415
72384733|NCT02927262|144277133|SUPERIORITY|||||||0.271||||||2-sided P-value from ANCOVA including treatment, age group, geographic region and use of FLT3-inhibiting agents per IRT as fixed factors and baseline score as covariate.|ANCOVA|||Month 12||||0.271
72384734|NCT02927262|144277133|SUPERIORITY|||||||0.179||||||2-sided P-value from ANCOVA including treatment, age group, geographic region and use of FLT3-inhibiting agents per IRT as fixed factors and baseline score as covariate.|ANCOVA|||Month 24/EoT||||0.179
72384735|NCT01697358|144277141|SUPERIORITY|||||||0.036|||||||Z-test using unpooled standard deviation|||||||0.036
72384736|NCT01697358|144277142|SUPERIORITY||||||<|0.001|||||||Regression, Linear|Variables included in the linear regression model are: baseline NPRS, treatment group, and virtual center.||||||< 0.001
72384737|NCT01697358|144277143|SUPERIORITY||||||<|0.001|||||||Regression, Linear|Variables included in the linear regression model are: baseline NPRS, treatment group, and virtual center.||||||< 0.001
72384738|NCT01697358|144277144|SUPERIORITY||||||<|0.001|||||||Regression, Linear|Variables included in the linear regression model are: baseline ODI, treatment group, and virtual center.||||||< 0.001
72558426|NCT05604209|144646471|SUPERIORITY||Median log2 fold change|1.09||||0.008|TWO_SIDED|95.0|0.39|3.61|||Wilcoxon (Mann-Whitney)|Within-arm log2 fold changes were statistically assessed using a two-sided exact Wilcoxon signed rank test.||The null hypothesis is that the median log2-fold change in magnitude of T-cell response to Mosaic-1 from baseline to day 42 within the C62-M4 vaccinated arm is zero.||3.61|0.39|0.008
72558427|NCT05604209|144646471|SUPERIORITY||Median log2 fold change|2.0||||0.016|TWO_SIDED|95.0|0.43|4.37|||Wilcoxon (Mann-Whitney)|Within-arm log2 fold changes were statistically assessed using a two-sided exact Wilcoxon signed rank test.||The null hypothesis is that the median log2-fold change in magnitude of T-cell response to Mosaic-1 from baseline to day 42 within the C1C62-M3M4 vaccinated arm is zero.||4.37|0.43|0.016
72558428|NCT05604209|144646471|SUPERIORITY|||||||0.189|||||||Wilcoxon (Mann-Whitney)|Between-arm comparisons in log2 fold changes were statistically assessed using a two-sided exact Wilcoxon rank-sum test.||The contrast is the magnitude of the T-cell response to Mosaic-1 from baseline to day 42 in C62-M4 versus C1C62-M3M4.The null hypothesis is that he distributions of the T-cell response to Mosaic-1 from pre-vaccination to day 42 are the same between the two vaccinated arms.||||0.189
72384739|NCT01697358|144277145|SUPERIORITY||||||<|0.001|||||||Regression, Linear|Variables included in the linear regression model are: baseline PCS, treatment group, and virtual center.||||||< 0.001
72384740|NCT01697358|144277146|SUPERIORITY||||||<|0.001|||||||Z-test using unpooled standard deviation|||||||< 0.001
72384741|NCT02963935|144277162|SUPERIORITY|The treatment policy estimand evaluated the treatment effect (liraglutide 3.0 mg vs placebo) at week 56 for all randomised subjects regardless of premature discontinuation of trial product.|Treatment difference|-3.45||||0.0003|TWO_SIDED|95.0|-5.31|-1.59|||ANCOVA|Missing observations were imputed from the placebo arm based on a jump to reference (x100) multiple imputation approach.|Liraglutide 3.0 mg - placebo|Treatrment policy estimand. The hypothesis and the alternative are: H: μliraglutide ≥ μplacebo against the alternative HA: μliraglutide \< μplacebo. μliraglutide and μplacebo denote the true mean of % weight change for liraglutide 3.0 mg and placebo group, respectively. Week 56 responses were analysed using an analysis of covariance model with treatment, BMI groups, and sex as factors and baseline body weight as covariate.||-1.59|-5.31|0.0003
72384742|NCT02963935|144277162|OTHER|The hypothetical estimand evaluated the treatment effect (liraglutide 3.0 mg vs placebo) for all randomised subjects assuming that all subjects remained on trial product (on-treatment principle)|Treatment difference|-4.59||||0|TWO_SIDED|95.0|-6.54|-2.64|||Mixed models repeated measurement (MMRM)||Liraglutide 3.0 mg - placebo|Hypothetical estimand. Analysis of on-drug data before first drug discontinuation date using a mixed model for repeated measurements with treatment, BMI groups, and sex as factors and baseline body weight as covariate, all nested within visit.||-2.64|-6.54|0.0000
72384743|NCT02963935|144277163|SUPERIORITY||Odds Ratio (OR)|2.51||||0.0003|TWO_SIDED|95.0|1.53|4.14|||Regression, Logistic||Liraglutide 3.0 mg/Placebo|Treatment policy estimand. Week 56 responses were analysed using a logistic regression model with treatment, BMI groups, and sex as factors and baseline body weight as covariate. Analysis of in-trial data with missing observations imputed from the placebo arm based on a jump to reference multiple (x100) imputation approach.||4.14|1.53|0.0003
72384744|NCT02963935|144277163|OTHER||Odds Ratio (OR)|2.84||||0|TWO_SIDED|95.0|1.75|4.61|||Mixed models repeated measurement (MMRM)||Liraglutide 3.0 mg/placebo|Hypothetical estimand. Analysis of on-drug before first drug discontinuation date using a mixed model for repeated measurements with treatment, BMI groups, and sex as factors and baseline body weight as covariate, all nested within visit. The MMRM was used to classify responders and analysed with a logistic regression with treatment as the only factor.||4.61|1.75|0.0000
72384745|NCT02963935|144277164|SUPERIORITY||Odds Ratio (OR)|1.78||||0.0469|TWO_SIDED|95.0|1.01|3.14|||Regression, Logistic||Liraglutide 3.0 mg/Placebo|Treatment policy estimand. Week 56 responses were analysed using a logistic regression model with treatment, BMI groups, and sex as factors and baseline body weight as covariate. Analysis of in-trial data with missing observations imputed from the placebo arm based on a jump to reference multiple (x10000) imputation approach.||3.14|1.01|0.0469
72384746|NCT02963935|144277164|OTHER||Odds Ratio (OR)|2.14||||0.0063|TWO_SIDED|95.0|1.24|3.69|||Mixed models repeated measurement (MMRM)||Liraglutide 3.0 mg/placebo|Hypothetical estimand. Analysis of on-drug before first drug discontinuation date using a mixed model for repeated measurements with treatment, BMI groups, and sex as factors and baseline body weight as covariate, all nested within visit. The MMRM was used to classify responders and analysed with a logistic regression with treatment as the only factor.||3.69|1.24|0.0063
72384747|NCT02963935|144277165|SUPERIORITY||Odds Ratio (OR)|2.26||||0.0311|TWO_SIDED|95.0|1.08|4.74|||Regression, Logistic||Liraglutide 3.0 mg/Placebo|Treatment policy estimand. Week 56 responses were analysed using a logistic regression model with treatment, BMI groups, and sex as factors and baseline body weight as covariate. Analysis of in-trial data with missing observations imputed from the placebo arm based on a jump to reference multiple (x100) imputation approach.||4.74|1.08|0.0311
72384748|NCT02963935|144277165|OTHER||Odds Ratio (OR)|2.74||||0.006|TWO_SIDED|95.0|1.33|5.62|||Mixed models repeated measurement (MMRM)||Liraglutide 3.0 mg/placebo|Hypothetical estimand. Analysis of on-drug before first drug discontinuation date using a mixed model for repeated measurements with treatment, BMI groups, and sex as factors and baseline body weight as covariate, all nested within visit. The MMRM was used to classify responders and analysed with a logistic regression with treatment as the only factor.||5.62|1.33|0.0060
72384749|NCT02963935|144277166|SUPERIORITY||Odds Ratio (OR)|3.32|||<|0.0001|TWO_SIDED|95.0|1.93|5.72|||Regression, Logistic||Liraglutide 3.0 mg/placebo|"Treatment policy estimand. Week 16 responders were analysed using a logistic regression model with treatment, BMI groups, and sex as factors and baseline body weight as covariate.~Missing values are considered as non-responders."||5.72|1.93|<0.0001
72384750|NCT02963935|144277167|SUPERIORITY||treatment difference|-2.72||||0.0063|TWO_SIDED|95.0|-4.68|-0.77|||ANCOVA||Liraglutide 3.0 mg - placebo|Analysis of in-trial data with missing observations imputed from the placebo arm based on a jump to reference multiple (x100) imputation approach. Week 56 responses were analysed using an analysis of covariance model with treatment, BMI groups, and sex as factors and baseline measurement of endpoint as covariate.||-0.77|-4.68|0.0063
72384751|NCT02963935|144277167|OTHER||Treatment difference|-3.45||||0.002|TWO_SIDED|95.0|-5.62|-1.28|||Mixed model repeated measurements (MMRM)||Liraglutide 3.0 mg - placebo|Analysis of on-drug before first drug discontinuation date using a mixed model for repeated measurements with treatment, BMI groups, and sex as factors and baseline measurement of endpoint as covariate, all nested within visit.||-1.28|-5.62|0.0020
72436908|NCT01212757|144387127|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|18.7||||0.0002|TWO_SIDED|95.0|9.1|28.2|||Cochran-Mantel-Haenszel|2-sided p-value is based on the CMH test adjusting for baseline DMARD use.|Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the CMH weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|In order to maintain the Type 1 error at the 0.05 significance level, the Hochberg procedure was to be used. The results of the endpoint were to be considered statistically significant if both the 30 mg apremilast dose versus placebo comparison and the 20 mg versus placebo comparison were statistically significant at the 0.05 significance level, or one of the comparisons was statistically significant at the 0.025 level.||28.2|9.1|0.0002
72436909|NCT01212757|144387128|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.14||||0.0042|TWO_SIDED|95.0|-0.236|-0.045|||ANCOVA|Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.||Pairwise comparisons (30 mg vs placebo and 20 mg vs placebo) were conducted conditional on the primary endpoint results. If the primary endpoint was statistically significant for both apremilast dose groups, pairwise comparisons for the HAQ-DI were to be evaluated at the 0.05 level using the Hochberg procedure. If only one apremilast dose was statistically significant, then only the comparison between that apremilast dose and placebo was conducted for the HAQ-DI score, at the 0.025 level.||-0.045|-0.236|0.0042
72436910|NCT01212757|144387128|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.104||||0.032|TWO_SIDED|95.0|-0.199|-0.009|||ANCOVA|Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.||Pairwise comparisons (30 mg vs placebo and 20 mg vs placebo) were conducted conditional on the primary endpoint results. If the primary endpoint was statistically significant for both apremilast dose groups, pairwise comparisons for the HAQ-DI were to be evaluated at the 0.05 level using the Hochberg procedure. If only one apremilast dose was statistically significant, then only the comparison between that apremilast dose and placebo was conducted for the HAQ-DI score, at the 0.025 level.||-0.009|-0.199|0.0320
72436911|NCT01212757|144387129|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|9.2||||0.0394|TWO_SIDED|95.0|0.5|17.8||Secondary endpoints from the placebo-controlled period (Weeks 16 and 24) were analyzed in a hierarchical fashion to control the Type I error rate as described above.|Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use.|Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the Cochran-Mantel-Haenszel (CMH) weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||17.8|0.5|0.0394
72436912|NCT01212757|144387129|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|15.7||||0.0009|TWO_SIDED|95.0|6.7|24.7||Secondary endpoints from the placebo-controlled period (Weeks 16 and 24) were analyzed in a hierarchical fashion to control the Type I error rate as described above.|Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use|Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the Cochran-Mantel-Haenszel (CMH) weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||24.7|6.7|0.0009
72436913|NCT01212757|144387130|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.121||||0.0191|TWO_SIDED|95.0|-0.222|-0.02|||ANCOVA|Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.||Secondary endpoints from the placebo-controlled period (Weeks 16 and 24) were analyzed in a hierarchical fashion to control the Type I error rate as described above.||-0.020|-0.222|0.0191
72436914|NCT01212757|144387130|SUPERIORITY||LS Mean Difference|-0.08||||0.1179|TWO_SIDED|95.0|-0.18|0.02|||ANCOVA||Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.|Secondary endpoints from the placebo-controlled period (Weeks 16 and 24) were analyzed in a hierarchical fashion to control the Type I error rate as described above.||0.020|-0.180|0.1179
72436915|NCT01212757|144387131|SUPERIORITY||LS Mean Difference|2.1||||0.0237|TWO_SIDED|95.0|0.28|3.92|||ANCOVA|Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.||Secondary endpoints from the placebo-controlled period (Weeks 16 and 24) were analyzed in a hierarchical fashion to control the Type I error rate as described above||3.92|0.28|0.0237
72436916|NCT01212757|144387131|SUPERIORITY||LS Mean Difference|1.36||||0.1388|TWO_SIDED|95.0|-0.44|3.15|||ANCOVA||Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.|Secondary endpoints from the placebo-controlled period (Weeks 16 and 24) were analyzed in a hierarchical fashion to control the Type I error rate as described above||3.15|-0.44|0.1388
72436917|NCT01212757|144387132|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|14.9||||0.0065|TWO_SIDED|95.0|4.3|25.5|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use.|Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the Cochran-Mantel-Haenszel (CMH) weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|Secondary endpoints from the placebo-controlled period (Weeks 16 and 24) were analyzed in a hierarchical fashion to control the Type I error rate as described above.||25.5|4.3|0.0065
72436918|NCT01212757|144387132|SUPERIORITY||Adjusted Difference|14.7||||0.0071|TWO_SIDED|95.0|4.1|25.2|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use.|Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the Cochran-Mantel-Haenszel (CMH) weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|Secondary endpoints from the placebo-controlled period (Weeks 16 and 24) were analyzed in a hierarchical fashion to control the Type I error rate as described above.||25.2|4.1|0.0071
72436919|NCT01212757|144387133|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-4.9||||0.0648|TWO_SIDED|95.0|-10.0|0.3|||ANCOVA|Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.||||0.3|-10.0|0.0648
72436920|NCT01212757|144387133|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-5.5||||0.0347|TWO_SIDED|95.0|-10.6|-0.4|||ANCOVA|Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.||||-0.4|-10.6|0.0347
72436921|NCT01212757|144387134|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.4||||0.3496|TWO_SIDED|95.0|-1.2|0.4|||ANCOVA|Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.||||0.4|-1.2|0.3496
72436922|NCT01212757|144387134|SUPERIORITY||LS Mean Difference|0.1||||0.8874|TWO_SIDED|95.0|-0.7|0.8|||ANCOVA|Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.||||0.8|-0.7|0.8874
72436923|NCT01212757|144387135|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.2||||0.5438|TWO_SIDED|95.0|-1.0|0.5|||ANCOVA|Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.||||0.5|-1.0|0.5438
72384752|NCT02963935|144277168|SUPERIORITY||Treatment difference|0.16||||0.8137|TWO_SIDED|95.0|-1.19|1.52|||ANCOVA||Liraglutide 3.0 mg - placebo|Treatment policy estimand. Analysis of in-trial data with missing observations imputed from the placebo arm based on a jump to reference multiple (x100) imputation approach. Week 56 responses were analysed using an analysis of covariance model with treatment, BMI groups, and sex as factors and baseline measurement of endpoint as covariate.||1.52|-1.19|0.8137
72384753|NCT02963935|144277168|OTHER||Treatment difference|0.16||||0.8053|TWO_SIDED|95.0|-1.12|1.43|||Mixed model repeated measurements (MMRM)||Liraglutide 3.0 mg- placebo|Hypothetical estimand. Analysis of on-drug before first drug discontinuation date using a mixed model for repeated measurements with treatment, BMI groups, and sex as factors and baseline measurement of endpoint as covariate, all nested within visit.||1.43|-1.12|0.8053
72384754|NCT02963935|144277169|SUPERIORITY|Superiority was not tested as part of confirmatory testing strategy.|Treatment difference|0.87||||0.6916|TWO_SIDED|95.0|-3.41|5.14|||ANCOVA||Liraglutide 3.0 mg - placebo|Treatment policy estimand. Analysis of in-trial data with missing observations imputed from the placebo arm based on a jump to reference multiple (x100) imputation approach. Week 56 responses were analysed using an analysis of covariance model with treatment, BMI groups, and sex as factors and baseline measurement of endpoint as covariate.||5.14|-3.41|0.6916
72384755|NCT02963935|144277169|OTHER||treatment difference|1.25||||0.5572|TWO_SIDED|95.0|-2.95|5.45|||Mixed models repeated measurements (MMRM||Liraglutide 3.0 mg - placebo|Hypothetical estimand. Analysis of on-drug before first drug discontinuation date using a mixed model for repeated measurements with treatment, BMI groups, and sex as factors and baseline measurement of endpoint as covariate, all nested within visit.||5.45|-2.95|0.5572
72384756|NCT02963935|144277170|SUPERIORITY|Superiority was not tested as part of confirmatory testing strategy.|Treatment difference|3.12||||0.6986|TWO_SIDED|95.0|-12.68|18.92|||ANCOVA||Liraglutide 3.0 mg - placebo|Treatment policy estimand. Analysis of in-trial data with missing observations imputed from the placebo arm based on a jump to reference multiple (x100) imputation approach. Week 56 responses were analysed using an analysis of covariance model with treatment, BMI groups, and sex as factors and baseline measurement of endpoint as covariate.||18.92|-12.68|0.6986
72384757|NCT02963935|144277170|OTHER||Treatment difference|7.66||||0.37|TWO_SIDED|95.0|-9.15|24.48|||Mixed model repeated measurements (MMRM)||Liraglutide 3.0 mg - placebo|Hypothetical estimand. Analysis of on-drug before first drug discontinuation date using a mixed model for repeated measurements with treatment, BMI groups, and sex as factors and baseline measurement of endpoint as covariate, all nested within visit.||24.48|-9.15|0.3700
72384758|NCT02337738|144277213|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.84||||0.0006|TWO_SIDED|95.0|-1.32|-0.364|||ANCOVA||Estimated Value was reported for the difference between TVP-1012 1mg and Placebo (TVP-1012 1mg - Placebo).|||-0.364|-1.320|0.0006
72384759|NCT02337738|144277213|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.6||||0.014|TWO_SIDED|95.0|-1.07|-0.122|||ANCOVA||Estimated Value was reported for the difference between TVP-1012 0.5mg and Placebo (TVP-1012 0.5mg - Placebo).|||-0.122|-1.070|0.0140
72384760|NCT00406354|144277224|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.2|STANDARD_ERROR_OF_MEAN|0.9|<|0.001|TWO_SIDED|95.0|-5.0|-1.5||p-value is from comparison of combined atomoxetine fast group plus atomoxetine slow group versus placebo group at Week 9|Mixed Models Analysis||Negative values are in favor of the atomoxetine arms.|||-1.5|-5.0|<.001
72384761|NCT00406354|144277225|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.4|STANDARD_ERROR_OF_MEAN|1.8|<|0.001|TWO_SIDED|95.0|-11.0|-3.8||p-value is from comparison of combined atomoxetine fast group plus atomoxetine slow group versus placebo group at Week 9.|Mixed Models Analysis||Negative values are in favor of the atomoxetine arms.|||-3.8|-11.0|<.001
72504630|NCT00112151|144540056|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05|TWO_SIDED||||||Regression, Linear|||As prespecified, the lower- and higher-range T groups were combined (Any T). The analysis compared change from baseline to 12 months in average lower body strength with any T to placebo in subjects assigned to PRT.||||<0.05
72504631|NCT00112151|144540056|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05|TWO_SIDED||||||Regression, Linear|||As prespecified, the lower- and higher-range T groups were combined (Any T). The analysis compared change from baseline to 12 months in average lower body strength with any T to placebo in subjects assigned to no PRT.||||<0.05
72384762|NCT00406354|144277226|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.5|STANDARD_ERROR_OF_MEAN|0.9|<|0.001|TWO_SIDED|95.0|-5.3|-1.8||p-value is from comparison of combined atomoxetine fast group plus atomoxetine slow group versus placebo group at Week 9.|Mixed Models Analysis||Negative values are in favor of the atomoxetine arms.|||-1.8|-5.3|<.001
72384763|NCT00406354|144277227|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.9|STANDARD_ERROR_OF_MEAN|1.0|<|0.001|TWO_SIDED|95.0|-5.8|-2.0||p-value is from comparison of combined atomoxetine fast group plus atomoxetine slow group versus placebo group at Week 9.|Mixed Models Analysis||Negative values are in favor of the atomoxetine arms.|||-2.0|-5.8|<.001
72384764|NCT00406354|144277228|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.6|-0.2||p-value is from comparison of combined atomoxetine fast group plus atomoxetine slow group versus placebo group at Week 9.|Mixed Models Analysis||Negative values are in favor of the atomoxetine arms.|||-0.2|-0.6|<.001
72436924|NCT01212757|144387135|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.3||||0.3759|TWO_SIDED|95.0|-0.4|1.0|||ANCOVA|Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.||||1.0|-0.4|0.3759
72436925|NCT01212757|144387136|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-3.51||||0.0035|TWO_SIDED|95.0|-5.86|-1.16|||ANCOVA|Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.||||-1.16|-5.86|0.0035
72384765|NCT00406354|144277229|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.1||0.006|TWO_SIDED|95.0|-0.4|-0.1||p-value is from comparison of combined atomoxetine fast group plus atomoxetine slow group versus placebo group at Week 9.|Mixed Models Analysis||Negative values are in favor of the atomoxetine arms.|||-0.1|-0.4|0.006
72384766|NCT00406354|144277230|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.5|STANDARD_ERROR_OF_MEAN|1.4||0.01|TWO_SIDED|95.0|-6.2|-0.9||p-value is from comparison of combined atomoxetine fast group plus atomoxetine slow group versus placebo group at Week 9.|Mixed Models Analysis||Negative values are in favor of the atomoxetine arms.|||-0.9|-6.2|0.010
72384767|NCT00406354|144277231|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.8|STANDARD_ERROR_OF_MEAN|0.7||0.01|TWO_SIDED|95.0|-3.2|-0.4||p-value is from comparison of combined atomoxetine fast group plus atomoxetine slow group versus placebo group at Week 9.|Mixed Models Analysis||Negative values are in favor of the atomoxetine arms.|||-0.4|-3.2|0.010
72384768|NCT00406354|144277232|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.4|STANDARD_ERROR_OF_MEAN|1.7||0.406|TWO_SIDED|95.0|-4.9|2.0||p-value is from comparison of combined atomoxetine fast group plus atomoxetine slow group versus placebo group at Week 9.|ANCOVA||Negative values are in favor of the atomoxetine arms.|||2.0|-4.9|0.406
72384769|NCT00406354|144277233|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|-1.1|-0.4||p-value is from comparison of combined atomoxetine fast group plus atomoxetine slow group versus placebo group at Week 9.|Mixed Models Analysis||Negative values are in favor of the atomoxetine arms.|||-0.4|-1.1|<.001
72384770|NCT00406354|144277234|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|-1.1|-0.4||p-value is from comparison of combined atomoxetine fast group plus atomoxetine slow group versus placebo group at Week 9.|Mixed Models Analysis||Negative values are in favor of the atomoxetine arms.|||-0.4|-1.1|<.001
72384771|NCT00406354|144277235|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|-1.1|-0.4||p-value is from comparison of combined atomoxetine fast group plus atomoxetine slow group versus placebo group at Week 9.|Mixed Models Analysis||Negative values are in favor of the atomoxetine arms.|||-0.4|-1.1|<.001
72384772|NCT00406354|144277236|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.0|STANDARD_ERROR_OF_MEAN|2.2||0.021|TWO_SIDED|95.0|0.8|9.3||p-value is from comparison of combined atomoxetine fast group plus atomoxetine slow group versus placebo group at Week 9.|ANCOVA||Positive values are in favor of the atomoxetine arms.|||9.3|0.8|0.021
72384773|NCT00406354|144277237|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.6|STANDARD_ERROR_OF_MEAN|3.1||0.017|TWO_SIDED|95.0|-13.8|-1.4||p-value is from comparison of combined atomoxetine fast group plus atomoxetine slow group versus placebo group at Week 9.|ANCOVA||Positive values are in favor of the atomoxetine arms.|||-1.4|-13.8|0.017
72384774|NCT00406354|144277238|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.5|STANDARD_ERROR_OF_MEAN|2.8||0.05|TWO_SIDED|95.0|0.0|10.9||p-value is from comparison of combined atomoxetine fast group plus atomoxetine slow group versus placebo group at Week 9.|ANCOVA||Positive values are in favor of the atomoxetine arms.|||10.9|-0.0|0.050
72436926|NCT01212757|144387136|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-4.45||||0.0002|TWO_SIDED|95.0|-6.76|-2.14|||ANCOVA|Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.||||-2.14|-6.76|0.0002
72384775|NCT00406354|144277239|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.7|STANDARD_ERROR_OF_MEAN|2.9|<|0.001|TWO_SIDED|95.0|4.9|16.4||p-value is from comparison of combined atomoxetine fast group plus atomoxetine slow group versus placebo group at Week 9.|ANCOVA||Positive values are in favor of the atomoxetine arms.|||16.4|4.9|<.001
72384776|NCT00406354|144277240|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.1|STANDARD_ERROR_OF_MEAN|3.3||0.015|TWO_SIDED|95.0|1.6|14.6||p-value is from comparison of combined atomoxetine fast group plus atomoxetine slow group versus placebo group at Week 9.|ANCOVA||Positive values are in favor of the atomoxetine arms.|||14.6|1.6|0.015
72384777|NCT00406354|144277241|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.0|STANDARD_ERROR_OF_MEAN|3.4||0.018|TWO_SIDED|95.0|1.4|14.7||p-value is from comparison of combined atomoxetine fast group plus atomoxetine slow group versus placebo group at Week 9.|ANCOVA||Positive results are in favor of the atomoxetine arms.|||14.7|1.4|0.018
72384778|NCT00406354|144277242|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.9|STANDARD_ERROR_OF_MEAN|3.3||0.138|TWO_SIDED|95.0|-1.6|11.5||p-value is from comparison of combined atomoxetine fast group plus atomoxetine slow group versus placebo group at Week 9.|ANCOVA||Positive values are in favor of the atomoxetine arms.|||11.5|-1.6|0.138
72384779|NCT00406354|144277243|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.193||||0.016||95.0|1.16|4.146||p-value is from comparison of combined atomoxetine fast group plus atomoxetine slow group versus placebo group at Week 9.|Log Rank|||||4.146|1.160|0.016
72384780|NCT00406354|144277244|SUPERIORITY_OR_OTHER|||||||0.102||95.0||||p-value is from comparison of atomoxetine fast group versus atomoxetine slow group for any clinically relevant categories of adverse events during the initial three weeks of study treatment|Fisher Exact|||||||0.102
72384781|NCT00406354|144277245|SUPERIORITY_OR_OTHER|||||||0.101||95.0||||p-value is from comparison of atomoxetine fast group versus atomoxetine slow group for any clinically relevant categories of adverse events during the nine-week study treatment period.|Fisher Exact|||||||0.101
72384782|NCT03467048|144277262|NON_INFERIORITY|Null hypothesis: McGrath Video Laryngoscopy is non-inferior to Macintosh direct laryngoscopy.|Odds Ratio (OR)|4.65|||<|0.01|TWO_SIDED|95.0|2.22|9.75|||t-test, 1 sided|||||9.75|2.22|<0.01
72384783|NCT03467048|144277263|NON_INFERIORITY|Null hypothesis: McGrath videolaryngoscopy is non-inferior to Direct laryngoscopy|Odds Ratio (OR)|0.3||||0.08|TWO_SIDED|0.975|0.04|2.28|||t-test, 1 sided|||||2.28|0.04|0.08
72384784|NCT03467048|144277264|NON_INFERIORITY|Null hypothesis: McGrath videolaryngoscopy is non-inferior to Direct laryngoscopy|Odds Ratio (OR)|0.87||||0.41|TWO_SIDED|97.5|0.1|7.77|||t-test, 1 sided|||||7.77|0.1|0.41
72384785|NCT04502979|144277272|SUPERIORITY||Mean Difference (Net)|0.31|STANDARD_ERROR_OF_MEAN|0.21||0.07|TWO_SIDED|95.0|-0.11|0.73||One-sided p-value for directional hypothesis. The threshold for statistical significance is p \< 0.05.|Mixed Models Analysis|||||0.73|-0.11|0.07
72436927|NCT01212757|144387137|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.4||||0.0004|TWO_SIDED|95.0|-0.61|-0.18|||ANCOVA|Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.||||-0.18|-0.61|0.0004
72384786|NCT04502979|144277273|SUPERIORITY||Mean Difference (Net)|-121.16|STANDARD_ERROR_OF_MEAN|65.73||0.04|TWO_SIDED|95.0|-252.73|10.41||One-sided p-value for directional hypothesis. The threshold for statistical significance is p \< 0.05.|Mixed Models Analysis|||||10.41|-252.73|0.04
72558429|NCT05604209|144646472|SUPERIORITY||Median log2 fold change|1.78|||<|0.001|TWO_SIDED|95.0|0.81|2.51|||Wilcoxon (Mann-Whitney)|Within-group log2 fold changes were statistically assessed using a two-sided exact Wilcoxon signed rank test.||The null hypothesis is that the median log2-fold change in magnitude of T-cell response to Mosaic-2 from baseline to day 42 within all vaccinees is zero.||2.51|0.81|<0.001
72618769|NCT01026038|144768112|SUPERIORITY_OR_OTHER||Percent Difference|0.0|||||TWO_SIDED|95.0|-3.6|6.6||||||Serotype 18C: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 13vPnC/13vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/7vPnC/13vPnC along with exact 2-sided 95% CI.||6.6|-3.6|
72436928|NCT01212757|144387137|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.47|||<|0.0001|TWO_SIDED|95.0|-0.68|-0.25|||ANCOVA|Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.||||-0.25|-0.68|<0.0001
72436929|NCT01212757|144387138|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|2.12||||0.0318|TWO_SIDED|95.0|0.19|4.06|||ANCOVA|Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.||||4.06|0.19|0.0318
72436930|NCT01212757|144387138|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.27||||0.7803|TWO_SIDED|95.0|-1.65|2.2|||ANCOVA|Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.||||2.20|-1.65|0.7803
72436931|NCT01212757|144387139|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|1.86||||0.0473|TWO_SIDED|95.0|0.02|3.7|||ANCOVA|Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.||||3.70|0.02|0.0473
72436932|NCT01212757|144387139|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|1.53||||0.0997|TWO_SIDED|95.0|-0.29|3.35|||ANCOVA|Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.||||3.35|-0.29|0.0997
72436933|NCT01212757|144387140|SUPERIORITY||Adjusted Difference|7.8||||0.1195|TWO_SIDED|95.0|-1.9|17.5||The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use.|Cochran-Mantel-Haenszel||Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the CMH weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||17.5|-1.9|0.1195
72436934|NCT01212757|144387140|SUPERIORITY||Adjusted Difference|15.5||||0.0026|TWO_SIDED|95.0|5.6|25.5|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use.|Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the CMH weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||25.5|5.6|0.0026
72436935|NCT01212757|144387141|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.7||||0.5067|TWO_SIDED|95.0|-6.8|3.4|||ANCOVA|Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.||||3.4|-6.8|0.5067
72436936|NCT01212757|144387141|SUPERIORITY_OR_OTHER_LEGACY||LS mean Difference|-3.5||||0.1762|TWO_SIDED|95.0|-8.5|1.6|||ANCOVA|Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.||||1.6|-8.5|0.1762
72436937|NCT01212757|144387142|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.4||||0.2719|TWO_SIDED|95.0|-1.2|0.3|||ANCOVA|Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.||||0.3|-1.2|0.2719
72436938|NCT01212757|144387142|SUPERIORITY||LS Mean Difference|0.0||||0.9727|TWO_SIDED|95.0|-0.8|0.7|||ANCOVA|Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.||||0.7|-0.8|0.9727
72436939|NCT01212757|144387143|SUPERIORITY||LS Mean Difference|-0.3||||0.3705|TWO_SIDED|95.0|-1.0|0.4|||ANCOVA|Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.||||0.4|-1.0|0.3705
72436940|NCT01212757|144387143|SUPERIORITY||LS Mean Difference|0.1||||0.6777|TWO_SIDED|95.0|-0.6|0.8|||ANCOVA|Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.||||0.8|-0.6|0.6777
72436941|NCT01212757|144387144|SUPERIORITY||LS Mean Difference|-3.14||||0.0097|TWO_SIDED|95.0|-5.52|-0.76|||ANCOVA|Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.||||-0.76|-5.52|0.0097
72384787|NCT01892865|144277274|SUPERIORITY_OR_OTHER||Mean Difference (Net)|23.6||||0.024|TWO_SIDED|95.0|3.15|44.0|||t-test, 2 sided|||The null hypothesis was that there would be no difference in predictive imprecision for the end of the operative day between the two arms||44|3.15|0.024
72384788|NCT01892865|144277274|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.16||||0.04|TWO_SIDED|95.0|1.01|1.34|||Poisson regression|||Null hypothesis: There would be no difference in throughput between the two arms||1.34|1.01|0.04
72436942|NCT01212757|144387144|SUPERIORITY||LS Mean Difference|-4.5||||0.0002|TWO_SIDED|95.0|-6.85|-2.16|||ANCOVA|Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.||||-2.16|-6.85|0.0002
72436943|NCT01212757|144387145|SUPERIORITY||LS Mean Difference|-0.38||||0.0011|TWO_SIDED|95.0|-0.6|-0.15|||ANCOVA|Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.||||-0.15|-0.60|0.0011
72436944|NCT01212757|144387145|SUPERIORITY||LS Mean Difference|-0.45||||0.0001|TWO_SIDED|95.0|-0.68|-0.23|||ANCOVA|Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.||||-0.23|-0.68|0.0001
72436945|NCT01212757|144387146|SUPERIORITY||LS Mean Difference|2.14||||0.0303|TWO_SIDED|95.0|0.2|4.07|||ANCOVA|Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.||||4.07|0.20|0.0303
72436946|NCT01212757|144387146|SUPERIORITY||LS mean Difference|0.16||||0.8704|TWO_SIDED|95.0|-1.76|2.08|||ANCOVA|Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.||||2.08|-1.76|0.8704
72494869|NCT01060059|144519112|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.03||||0.026|TWO_SIDED|95.0|1.0|1.05|||Regression, Logistic|If several variables had Spearman's rho \> 0.4 (for continuous) and Cramer's V \> 0.4 (for categorical covariates), only one was left in the model.||Logistic regression analysis was used to determine if greater height (1 cm higher) was associated with treatment choice at baseline. Odds ratios were determined and if the odds ratio was greater than 1, it indicated it is more likely to initiate exenatide treatment. Covariates with more than 30% observations missing were omitted in this analysis. Missing values for remaining numeric covariates were replaced with means, and for categorical ones - with modes.||1.05|1.00|0.026
72384789|NCT01892865|144277275|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.16||||0.04|TWO_SIDED|95.0|1.01|1.34|||Poisson Regression|||Null hypothesis was that there was no difference in throughput between the two scheduling methods||1.34|1.01|0.04
72384790|NCT01892865|144277276|SUPERIORITY_OR_OTHER|||||||0.04|||||||t-test, 2 sided|||Null hypothesis: There would be no difference in personnel satisfaction between the groups||||0.04
72384791|NCT01892865|144277277|SUPERIORITY_OR_OTHER|||||||0.44|||||||Chi-squared|||Null hypothesis was that there would be no difference in the adverse event rates between the two scheduling methodologies||||0.44
72384792|NCT06350474|144277323|NON_INFERIORITY|The non-inferiority margin is -3.|Mean Difference (Final Values)|0.346|||<|0.0001|TWO_SIDED|95.0|-0.5|1.1||One-sided test for non-inferiority.|ANOVA|Adjusted for four dichotomous randomization strata.|Direction of difference is Discontinue - Continue.|The non-inferiority test was a priori designed to be conducted on the per-protocol (PP) population.||1.1|-0.5|<0.0001
72384793|NCT06350474|144277324|SUPERIORITY||Mean Difference (Final Values)|-0.11||||0.414|TWO_SIDED|95.0|-0.4|0.2|||ANOVA|Adjusted for four dichotomous randomization strata.|Direction of difference is Discontinue - Continue.|||0.2|-0.4|0.414
72384794|NCT06350474|144277325|SUPERIORITY||Mean Difference (Final Values)|0.95||||0.241|TWO_SIDED|95.0|-1.0|2.9|||ANOVA|Adjusted for four dichotomous randomization strata.|Direction of difference is Discontinue - Continue.|||2.9|-1.0|0.241
72384795|NCT06350474|144277326|SUPERIORITY||Mean Difference (Final Values)|-0.92||||0.233|TWO_SIDED|95.0|-2.5|0.6|||ANOVA|Adjusted for four dichotomous randomization strata.|Direction of difference is Discontinue - Continue.|||0.6|-2.5|0.233
72384796|NCT06350474|144277327|SUPERIORITY||Mean Difference (Final Values)|0.28||||0.42|TWO_SIDED|95.0|-0.4|0.97|||t-test, 2 sided||Direction of difference is Discontinue - Continue.|||0.97|-0.4|0.42
72384797|NCT06350474|144277328|SUPERIORITY||Mean Difference (Final Values)|-0.15||||0.69|TWO_SIDED|95.0|-0.92|0.61|||t-test, 2 sided||Direction of difference is Discontinue - Continue.|||0.61|-0.92|0.69
72504632|NCT00112151|144540057|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05|TWO_SIDED||||||Regression, Linear|||As prespecified, the lower- and higher-range T groups were combined (Any T). The analysis compared change from baseline to 12 months in leg extensor power with any T to placebo in subjects assigned to PRT.||||<0.05
72504633|NCT00112151|144540057|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05|TWO_SIDED||||||Regression, Linear|||As prespecified, the lower- and higher-range T groups were combined (Any T). The analysis compared change from baseline to 12 months in leg extensor power with any T to placebo in subjects assigned to no PRT.||||<0.05
72384798|NCT06350474|144277329|SUPERIORITY||Difference in % Participants|2.5||||0.275|TWO_SIDED|95.0|-1.5|6.5|||Fisher Exact||Confidence interval calculated using the Newcombe-Wilson method without continuity correction. Direction of difference is Discontinue - Continue.|||6.5|-1.5|0.275
72384799|NCT06350474|144277331|SUPERIORITY||Difference in % Participants|0.8||||0.686|TWO_SIDED|95.0|-1.6|3.4|||Fisher Exact||Confidence interval calculated using the Newcombe-Wilson method without continuity correction. Direction of difference is Discontinue - Continue.|||3.4|-1.6|0.686
72384800|NCT06350474|144277332|SUPERIORITY||Difference in % Participants|13.9||||0.001|TWO_SIDED|95.0|5.6|21.8|||Fisher Exact||Confidence interval calculated using the Newcombe-Wilson method without continuity correction. Direction of difference is Discontinue - Continue.|Null hypothesis: proportion of participants with at least one AE is the same in Discontinue and Continue arms.||21.8|5.6|0.0010
72384801|NCT06350474|144277333|SUPERIORITY||Rate Ratio|1.95|||<|0.0001|TWO_SIDED|95.0|1.51|2.53|||Poisson Regression|||Rate ratio, confidence interval, and p-value calculated using Poisson Regression with an offset for the log of follow-up time in weeks. The total number of follow-up weeks in the DA-discontinue and DA-continue arms are 1486.3 and 1471.4 weeks, respectively. Ratio is Discontinue / Continue.||2.53|1.51|<0.0001
72504634|NCT00112151|144540058|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05|TWO_SIDED||||||Regression, Linear|||As prespecified, the lower- and higher-range T groups were combined (Any T). The analysis compared change from baseline to 12 months in fat mass measured by dual x-ray absorptiometry (DXA) with any T to placebo in subjects assigned to PRT.||||<0.05
72504635|NCT00112151|144540058|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05|TWO_SIDED||||||Regression, Linear|||As prespecified, the lower- and higher-range T groups were combined (Any T). The analysis compared change from baseline to 12 months in fat mass measured by dual x-ray absorptiometry (DXA) with any T to placebo in subjects assigned to no PRT.||||<0.05
72504636|NCT00112151|144540059|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05|TWO_SIDED||||||Regression, Linear|||As prespecified, the lower- and higher-range T groups were combined (Any T). The analysis compared change from baseline to 12 months in fat free mass measured by dual x-ray absorptiometry (DXA) with any T to placebo in subjects assigned to PRT.||||<0.05
72384802|NCT06350474|144277334|SUPERIORITY||Difference in % Participants|2.03||||0.1758|TWO_SIDED|95.0|-0.6|5.0|||Fisher Exact||Confidence interval calculated using the Newcombe-Wilson method without continuity correction. Direction of difference is Discontinue - Continue.|Null hypothesis: proportion of participants changing assigned regimen is the same in Discontinue and Continue arms.||5.0|-0.6|0.1758
72384803|NCT02160990|144277420|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||||||<.001
72384804|NCT02160990|144277421|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||||||<.001
72384805|NCT02160990|144277422|SUPERIORITY_OR_OTHER|||||||0.23|TWO_SIDED||||||ANCOVA|||||||0.23
72504637|NCT00112151|144540059|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05|TWO_SIDED||||||Regression, Linear|||As prespecified, the lower- and higher-range T groups were combined (Any T). The analysis compared change from baseline to 12 months in fat free mass measured by dual x-ray absorptiometry (DXA) with any T to placebo in subjects assigned to no PRT.||||<0.05
72494870|NCT01060059|144519113|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.37||||0.007|TWO_SIDED|95.0|0.18|0.77|||Regression, Logistic|If several variables had Spearman's rho \> 0.4 (for continuous) and Cramer's V \> 0.4 (for categorical covariates), only one was left in the model.||Logistic regression analysis was used to determine if higher baseline creatinine (1mg/dL higher) was associated with treatment choice at baseline. Odds ratios were determined and if the odds ratio was greater than 1, it indicated it is more likely to initiate exenatide treatment. Covariates with more than 30% observations missing were omitted in this analysis. Missing values for remaining numeric covariates were replaced with means, and for categorical ones - with modes.||0.77|0.18|0.007
72494871|NCT01060059|144519113|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.99||||0.094|TWO_SIDED|95.0|0.97|1.0|||Regression, Logistic|If several variables had Spearman's rho \> 0.4 (for continuous) and Cramer's V \> 0.4 (for categorical covariates), only one was left in the model.||Logistic regression analysis was used to determine if higher baseline fasting HDL cholesterol (1mg/dL higher) was associated with treatment choice at baseline. Odds ratios were determined and if the odds ratio was greater than 1, it indicated it is more likely to initiate exenatide treatment. Covariates with more than 30% observations missing were omitted in this analysis. Missing values for remaining numeric covariates were replaced with means, and for categorical ones - with modes.||1.00|0.97|0.094
72504739|NCT03114969|144540498|SUPERIORITY||Odds Ratio (OR)|2.979||||0.05|TWO_SIDED|95.0|0.999|8.882||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator.|||8.882|0.999|0.050
72618770|NCT01026038|144768112|SUPERIORITY_OR_OTHER||Percent Difference|0.0|||||TWO_SIDED|95.0|-3.7|6.3||||||Serotype 18C: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 13vPnC/13vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/13vPnC/13vPnC along with exact 2-sided 95% CI.||6.3|-3.7|
72384806|NCT00734474|144277427|NON_INFERIORITY_OR_EQUIVALENCE|Family-wise Type I error rate was controlled by applying gatekeeping strategies.|LS Mean Difference|-0.71|||<|0.001|TWO_SIDED|95.0|-0.87|-0.55||P-value is adjusted for multiplicity, based on tree-gatekeeping strategy. To determine significance, p-value is compared to the family-wise 1-sided Type I error of 0.025. The confidence interval is not adjusted for multiplicity.|ANCOVA|||"Power was estimated at approximately 89% based on a simulation study using the most likely pharmacodynamic model, assuming a 20% drop out rate (missing completely at random) at 52 weeks and enrollment of 5 participants per week. A predictive power calculation was planned to select either 263 or 333 as the minimum total sample size needed (sum of Stage 1 and 2) per arm. If the predictive power of the higher LY2189265 dose based on 263 participants in total exceeded 85%, then 263 would be used."||-0.55|-0.87|<0.001
72384807|NCT00734474|144277427|NON_INFERIORITY_OR_EQUIVALENCE|Family-wise Type I error rate was controlled by applying a gatekeeping strategy.|LS Mean Difference|-0.47|||<|0.001|TWO_SIDED|95.0|-0.63|-0.31||P-value is adjusted for multiplicity, based on tree-gatekeeping strategy. To determine significance, p-value is compared to the family-wise 1-sided Type I error of 0.025. The confidence interval is not adjusted for multiplicity.|ANCOVA|||"Power was estimated at approximately 89% based on a simulation study using the most likely pharmacodynamic model, assuming a 20% drop out rate (missing completely at random) at 52 weeks and enrollment of 5 participants per week. A predictive power calculation was planned to select either 263 or 333 as the minimum total sample size needed (sum of Stage 1 and 2) per arm. If the predictive power of the higher LY2189265 dose based on 263 participants in total exceeded 85%, then 263 would be used."||-0.31|-0.63|<0.001
72384808|NCT00734474|144277427|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.71|||<|0.001|TWO_SIDED|95.0|-0.87|-0.55||P-value is adjusted for multiplicity, based on tree-gatekeeping strategy. To determine significance, p-value is compared to the family-wise 1-sided Type I error of 0.025. The confidence interval is not adjusted for multiplicity.|ANCOVA|||Superiority analysis||-0.55|-0.87|<0.001
72384809|NCT00734474|144277427|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.47|||<|0.001|TWO_SIDED|95.0|-0.63|-0.31||P-value is adjusted for multiplicity, based on tree-gatekeeping strategy. To determine significance, p-value is compared to the family-wise 1-sided Type I error of 0.025. The confidence interval is not adjusted for multiplicity.|ANCOVA|||Superiority analysis||-0.31|-0.63|<0.001
72384810|NCT00734474|144277429|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.26|||<|0.001|TWO_SIDED|95.0|-1.42|-1.09||Comparison at 26 weeks. P-value adjusted for multiplicity based on tree-gatekeeping strategy. To determine significance, p-value is compared to the family-wise 1-sided Type I error of 0.025. The confidence interval is not adjusted for multiplicity.|ANCOVA|||Superiority analysis||-1.09|-1.42|<0.001
72436947|NCT01212757|144387147|SUPERIORITY||Adjusted Difference|3.6||||0.6022|TWO_SIDED|95.0|-9.9|17.2|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use.|Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the CMH weights.|||17.2|-9.9|0.6022
72436948|NCT01212757|144387147|SUPERIORITY||Adjusted Difference|1.3||||0.8462|TWO_SIDED|95.0|-12.1|14.7|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use.|Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the CMH weights.|||14.7|-12.1|0.8462
72436949|NCT01212757|144387148|SUPERIORITY||Adjusted Difference|2.8||||0.7337|TWO_SIDED|95.0|-13.3|18.9|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use.|Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the Cochran-Mantel-Haenszel (CMH) weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||18.9|-13.3|0.7337
72436950|NCT01212757|144387148|SUPERIORITY||Adjusted Difference|3.3||||0.6881|TWO_SIDED|95.0|-12.7|19.3|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use.|Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the Cochran-Mantel-Haenszel (CMH) weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||19.3|-12.7|0.6881
72436951|NCT01212757|144387149|SUPERIORITY||Adjusted Difference|17.5||||0.0014|TWO_SIDED|95.0|7.0|27.9|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use.|Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the CMH weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||27.9|7.0|0.0014
72436952|NCT01212757|144387149|SUPERIORITY||Adjusted Difference|22.1||||0.0001|TWO_SIDED|95.0|11.7|32.5|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use.|Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the CMH weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||32.5|11.7|0.0001
72436953|NCT01212757|144387150|SUPERIORITY||Adjusted Difference|6.6||||0.3376|TWO_SIDED|95.0|-6.8|20.0|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use.|Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the CMH weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||20.0|-6.8|0.3376
72436954|NCT01212757|144387150|SUPERIORITY||Adjusted Difference|6.1||||0.3756|TWO_SIDED|95.0|-7.2|19.4|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use.|Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the CMH weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||19.4|-7.2|0.3756
72494872|NCT01060059|144519113|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.0||||0.259|TWO_SIDED|95.0|1.0|1.01|||Regression, Logistic|If several variables had Spearman's rho \> 0.4 (for continuous) and Cramer's V \> 0.4 (for categorical covariates), only one was left in the model.||Logistic regression analysis was used to determine if higher baseline fasting total cholesterol (1mg/dL higher) was associated with treatment choice at baseline. Odds ratios were determined and if the odds ratio was greater than 1, it indicated it is more likely to initiate exenatide treatment. Covariates with more than 30% observations missing were omitted in this analysis. Missing values for remaining numeric covariates were replaced with means, and for categorical ones - with modes.||1.01|1.00|0.259
72494873|NCT01060059|144519113|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.0||||0.123|TWO_SIDED|95.0|1.0|1.0|||Regression, Logistic|If several variables had Spearman's rho \> 0.4 (for continuous) and Cramer's V \> 0.4 (for categorical covariates), only one was left in the model.||Logistic regression analysis was used to determine if higher baseline fasting triglycerides (1mg/dL higher) was associated with treatment choice at baseline. Odds ratios were determined and if the odds ratio was greater than 1, it indicated it is more likely to initiate exenatide treatment. Covariates with more than 30% observations missing were omitted in this analysis. Missing values for remaining numeric covariates were replaced with means, and for categorical ones - with modes.||1.00|1.00|0.123
72494874|NCT00848354|144519115|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Cochran-Mantel-Haenszel|||Cochran-Mantel-Haenszel chi-square test, stratified by country, was used to calculate p-value. Assuming ACR50 response at Week 24 to be 23% in the DMARD combination therapy group and 37% in the etanercept + methotrexate group, a study enrolling 276 participants assigned to etanercept + methotrexate and 138 participants assigned to DMARD combination therapy has 80% power to reject the null hypothesis of no difference in response rates testing at the type I error = 0.05 level.||||<0.0001
72494875|NCT00848354|144519116|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||Analysis of covariance (ANCOVA) model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value.||||<0.0001
72558430|NCT05604209|144646472|SUPERIORITY||Median log2 fold change|1.57||||0.008|TWO_SIDED|95.0|0.63|3.89|||Wilcoxon (Mann-Whitney)|Within-arm log2 fold changes were statistically assessed using a two-sided exact Wilcoxon signed rank test.||The null hypothesis is that the median log2-fold change in magnitude of T-cell response to Mosaic-2 from baseline to day 42 within the C62-M4 vaccinated arm is zero.||3.89|0.63|0.008
72558431|NCT05604209|144646472|SUPERIORITY||Median log2 fold change|1.78||||0.016|TWO_SIDED|95.0|0.7|3.79|||Wilcoxon (Mann-Whitney)|Within-arm log2 fold changes were statistically assessed using a two-sided exact Wilcoxon signed rank test.||The null hypothesis is that the median log2-fold change in magnitude of T-cell response to Mosaic-2 from baseline to day 42 within the C162-M3M4 vaccinated arm is zero.||3.79|0.70|0.016
72436955|NCT01212757|144387151|SUPERIORITY||Adjusted Difference|6.8||||0.3959|TWO_SIDED|95.0|-8.7|22.2|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use.|Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the CMH weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||22.2|-8.7|0.3959
72494876|NCT00848354|144519117|SUPERIORITY_OR_OTHER|||||||0.0003|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for vitality domain at Week 24.||||0.0003
72494877|NCT00848354|144519117|SUPERIORITY_OR_OTHER|||||||0.0002|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for mental component at Week 24.||||0.0002
72558432|NCT05604209|144646472|SUPERIORITY|||||||0.955|||||||Wilcoxon (Mann-Whitney)|Between-arm comparisons in log2 fold changes were statistically assessed using a two-sided exact Wilcoxon rank-sum test.||The contrast is the magnitude of the T-cell response to Mosaic-2 from baseline to day 42 in C62-M4 versus C1C62-M3M4.The null hypothesis is that he distributions of the T-cell response to Mosaic-2 from pre-vaccination to day 42 are the same between the two vaccinated arms.||||0.955
72558433|NCT05604209|144646473|SUPERIORITY||Median Difference (Net)|2.0||||0.125|TWO_SIDED|95.0|-1.0|4.0|||Wilcoxon (Mann-Whitney)|Within-group changes in breadth from baseline to day 56 were statistically assessed using a two-sided exact Wilcoxon signed rank test.||The null hypothesis is that the median change in breadth of T-cell response to HIV-1 subpools from baseline to day 56 within all vaccinees is zero.||4|-1|0.125
72436956|NCT01212757|144387151|SUPERIORITY||Adjusted Difference|6.8||||0.3941|TWO_SIDED|95.0|-8.7|22.4|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use.|Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the Cochran-Mantel-Haenszel (CMH) weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||22.4|-8.7|0.3941
72494878|NCT00848354|144519117|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for physical component at Week 24.||||<0.0001
72494879|NCT00848354|144519118|SUPERIORITY_OR_OTHER|||||||0.027|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model on ranks of change in mTSS with treatment group and center main effects and the Baseline rank as covariate was used to calculate p-value.||||0.0270
72436957|NCT01212757|144387152|SUPERIORITY||Adjusted Difference|12.1||||0.0142|TWO_SIDED|95.0|2.6|21.7|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use.|Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the CMH weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||21.7|2.6|0.0142
72436958|NCT01212757|144387152|SUPERIORITY||Adjusted Difference|20.5||||0.0001|TWO_SIDED|95.0|10.8|30.3|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use|Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the CMH weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||30.3|10.8|0.0001
72436959|NCT01212757|144387153|SUPERIORITY||Adjusted Difference|5.6||||0.0589|TWO_SIDED|95.0|-0.2|11.3|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use.|Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the CMH weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||11.3|-0.2|0.0589
72436960|NCT01212757|144387153|SUPERIORITY||Adjusted Difference|9.8||||0.0034|TWO_SIDED|95.0|3.4|16.1|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use.|Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the CMH weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||16.1|3.4|0.0034
72436961|NCT01212757|144387154|SUPERIORITY||Adjusted Difference|0.6||||0.562|TWO_SIDED|95.0|-1.5|2.7|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use.|Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the CMH weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||2.7|-1.5|0.5620
72436962|NCT01212757|144387154|SUPERIORITY||Adjusted Difference|3.1||||0.057|TWO_SIDED|95.0|0.0|6.2|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use.|Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the CMH weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||6.2|-0.0|0.0570
72436963|NCT01212757|144387155|SUPERIORITY||Adjusted Difference|3.1||||0.3629|TWO_SIDED|95.0|-3.5|9.6|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use.|Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the CMH weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||9.6|-3.5|0.3629
72494880|NCT00848354|144519119|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-values. ANCOVA was ran at each time-point shown, however as p-values obtained were identical, only one p-value is presented (which is applicable to each time-point - Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 - independently).||||<0.0001
72494881|NCT00848354|144519122|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.39|||<|0.0001|TWO_SIDED|95.0|2.25|18.2||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 2.||18.2|2.25|<0.0001
72494882|NCT00848354|144519122|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.99|||<|0.0001|TWO_SIDED|95.0|2.62|9.49||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 4.||9.49|2.62|<0.0001
72494883|NCT00848354|144519122|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.6|||<|0.0001|TWO_SIDED|95.0|2.19|5.94||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 8.||5.94|2.19|<0.0001
72494884|NCT00848354|144519122|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.1|||<|0.0001|TWO_SIDED|95.0|2.57|6.53||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 12.||6.53|2.57|<0.0001
72436964|NCT01212757|144387155|SUPERIORITY||Adjusted Difference|5.4||||0.1323|TWO_SIDED|95.0|-1.5|12.3|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use|Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the CMH weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||12.3|-1.5|0.1323
72436965|NCT01212757|144387156|SUPERIORITY||Adjusted Difference|-0.6||||0.7273|TWO_SIDED|95.0|-4.3|3.0|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use.|Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the CMH weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||3.0|-4.3|0.7273
72494885|NCT00848354|144519122|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.93|||<|0.0001|TWO_SIDED|95.0|2.51|6.16||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 16.||6.16|2.51|<0.0001
72494886|NCT00848354|144519122|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.82|||<|0.0001|TWO_SIDED|95.0|2.46|5.93||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 20.||5.93|2.46|<0.0001
72436966|NCT01212757|144387156|SUPERIORITY||Adjusted Difference|2.4||||0.2929|TWO_SIDED|95.0|-2.0|6.8|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use.|Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the CMH weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||6.8|-2.0|0.2929
72436967|NCT01212757|144387157|SUPERIORITY||Adjusted Difference|-2.2||||0.7023|TWO_SIDED|95.0|-13.5|9.1|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use.|Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the CMH weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||9.1|-13.5|0.7023
72436968|NCT01212757|144387157|SUPERIORITY||Adjusted Difference|5.9||||0.3305|TWO_SIDED|95.0|-5.9|17.7|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use.|Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the CMH weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||17.7|-5.9|0.3305
72436969|NCT01212757|144387158|SUPERIORITY||Adjusted Difference|0.3||||0.9698|TWO_SIDED|95.0|-16.0|16.6|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use.|Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the CMH weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||16.6|-16.0|0.9698
72436970|NCT01212757|144387158|SUPERIORITY||Adjusted Difference|1.9||||0.8205|TWO_SIDED|95.0|-14.3|18.1|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use.|Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the CMH weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||18.1|-14.3|0.8205
72436971|NCT01212757|144387159|SUPERIORITY||Adjusted Difference|-1.2||||0.8424|TWO_SIDED|95.0|-12.7|10.3|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use.|Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the CMH weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||10.3|-12.7|0.8424
72436972|NCT01212757|144387159|SUPERIORITY||Adjusted Difference|5.9||||0.3395|TWO_SIDED|95.0|-6.0|17.8|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use.|Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the CMH weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||17.8|-6.0|0.3395
72436973|NCT01212757|144387160|SUPERIORITY||Adjusted Difference|5.9||||0.4811|TWO_SIDED|95.0|-10.3|22.1|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use.|Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the CMH weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||22.1|-10.3|0.4811
72436974|NCT01212757|144387160|SUPERIORITY||Adjusted Difference|3.3||||0.6965|TWO_SIDED|95.0|-13.3|19.5|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use.|Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the CMH weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||19.5|-13.3|0.6965
72436975|NCT01324453|144387191|SUPERIORITY|||||||0.9|||||||Kruskal-Wallis|||||||0.90
72436976|NCT01324453|144387192|SUPERIORITY|||||||0.81|||||||Kruskal-Wallis|||||||0.81
72436977|NCT01324453|144387193|SUPERIORITY|||||||0.45|||||||Chi-squared|||||||0.45
72494887|NCT00848354|144519122|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.39|||<|0.0001|TWO_SIDED|95.0|3.41|8.53||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 24.||8.53|3.41|<0.0001
72494888|NCT00848354|144519124|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.84|||<|0.0001|TWO_SIDED|95.0|2.37|6.21||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 2.||6.21|2.37|<0.0001
72436978|NCT01324453|144387194|SUPERIORITY|||||||0.58|||||||t-test, 2 sided|||||||0.58
72436979|NCT01324453|144387195|SUPERIORITY|||||||0.86|||||||Kruskal-Wallis|||||||0.86
72436980|NCT01324453|144387196|SUPERIORITY|||||||1|||||||Kruskal-Wallis|||||||1.00
72436981|NCT01324453|144387197|SUPERIORITY|||||||0.58|||||||Kruskal-Wallis|||||||0.58
72436982|NCT01324453|144387198|SUPERIORITY|||||||0.77|||||||Kruskal-Wallis|||||||0.77
72436983|NCT02477670|144387243|SUPERIORITY||SPCD Weighted OLS z-statistic|-1.79||||0.073|TWO_SIDED|95.0|-3.75|0.17|||Mixed Models Analysis|||Sequential Parallel Comparison Design (SPCD) Weighted Ordinary Least Squares (OLS) z-statistic. Treatment differences in each stage were estimated by the Mixed Model Repeated Measures (MMRM).||0.17|-3.75|0.073
72618771|NCT01026038|144768112|SUPERIORITY_OR_OTHER||Percent Difference|0.0|||||TWO_SIDED|95.0|-6.6|6.4||||||Serotype 18C: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 7vPnC/7vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/13vPnC/13vPnC along with exact 2-sided 95% CI.||6.4|-6.6|
72436984|NCT02477670|144387244|SUPERIORITY||SPCD Weighted OLS z-statistic|-2.25||||0.025|TWO_SIDED|95.0|-4.21|-0.29|||Mixed Models Analysis|||Treatment differences in each stage were estimated by the MMRM.||-0.29|-4.21|0.025
72436985|NCT02477670|144387245|SUPERIORITY||SPCD Weighted OLS z-statistic|-2.2||||0.027|TWO_SIDED|95.0|-4.16|-0.24|||Mixed Models Analysis|||Treatment differences in each stage were estimated by the MMRM.||-0.24|-4.16|0.027
72436986|NCT02477670|144387246|SUPERIORITY||SPCD Weighted OLS z-statistic|-2.26||||0.024|TWO_SIDED|95.0|-4.22|-0.3|||Mixed Models Analysis|||Treatment differences in each stage were estimated by the MMRM.||-0.3|-4.22|0.024
72436987|NCT02477670|144387247|SUPERIORITY||SPCD Weighted OLS z-statistic|-2.6||||0.009|TWO_SIDED|95.0|-4.56|-0.64|||Mixed Models Analysis|||Treatment differences in each stage were estimated by the MMRM.||-0.64|-4.56|0.009
72436988|NCT02477670|144387248|SUPERIORITY||SPCD Weighted OLS z-statistic|-0.39||||0.7|TWO_SIDED|95.0|-2.35|1.57|||Mixed Models Analysis|||Treatment differences in each stage were estimated by the MMRM.||1.57|-2.35|0.700
72558434|NCT00112437|144646474|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|3.5|||<=|0.001|TWO_SIDED|95.0|2.54|4.45||Significance for the primary endpoint was achieved through stepdown trend-test, the highest dose group was removed and the test was repeated until lack of significance was observed.|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The primary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on lumbar spine BMD compared to placebo over 12 months. The primary hypothesis states that odanacatib will increase lumbar spine BMD compared to placebo over 12 months.||4.45|2.54|<=0.001
72436989|NCT02477670|144387249|SUPERIORITY||SPCD Weighted OLS z-statistic|-1.93||||0.054|TWO_SIDED|95.0|-3.89|0.03|||Mixed Models Analysis|||Treatment differences in each stage were estimated by the MMRM.||0.03|-3.89|0.054
72618772|NCT01026038|144768112|SUPERIORITY_OR_OTHER||Percent Difference|-1.7|||||TWO_SIDED|95.0|-6.2|4.5||||||Serotype 19F: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 13vPnC/13vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/7vPnC/13vPnC along with exact 2-sided 95% CI.||4.5|-6.2|
72494889|NCT00848354|144519124|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.34|||<|0.0001|TWO_SIDED|95.0|2.19|5.11||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 4.||5.11|2.19|<0.0001
72436990|NCT02477670|144387250|SUPERIORITY||SPCD Weighted OLS z-statistic|-0.35||||0.723|TWO_SIDED|95.0|-2.31|1.61|||Mixed Models Analysis|||Treatment differences in each stage were estimated by the MMRM.||1.61|-2.31|0.723
72436991|NCT02477670|144387251|SUPERIORITY||SPCD Weighted OLS z-statistic|-1.85||||0.064|TWO_SIDED|95.0|-3.81|0.11|||Mixed Models Analysis|||Treatment differences in each stage were estimated by the MMRM.||0.11|-3.81|0.064
72494890|NCT00848354|144519124|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.9|||<|0.0001|TWO_SIDED|95.0|1.9|4.43||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 8.||4.43|1.90|<0.0001
72494891|NCT00848354|144519124|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.2|||<|0.0001|TWO_SIDED|95.0|2.06|4.96||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 12.||4.96|2.06|<0.0001
72436992|NCT02477670|144387252|SUPERIORITY||SPCD Weighted OLS z-statistic|-1.64||||0.1|TWO_SIDED|95.0|-3.6|0.32|||Mixed Models Analysis|||Treatment differences in each stage were estimated by the MMRM.||0.32|-3.6|0.100
72436993|NCT02477670|144387253|SUPERIORITY||SPCD Weighted OLS z-statistic|-0.86||||0.388|TWO_SIDED|95.0|-2.82|1.1|||Mixed Models Analysis|||Treatment differences in each stage were estimated by the MMRM.||1.1|-2.82|0.388
72436994|NCT02477670|144387254|SUPERIORITY||SPCD Weighted OLS z-statistic|-0.9||||0.367|TWO_SIDED|95.0|-2.86|1.06|||Mixed Models Analysis|||Treatment differences in each stage were estimated by the MMRM.||1.06|-2.86|0.367
72494892|NCT00848354|144519124|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.91|||<|0.0001|TWO_SIDED|95.0|2.46|6.21||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 16.||6.21|2.46|<0.0001
72494893|NCT00848354|144519124|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.9|||<|0.0001|TWO_SIDED|95.0|2.45|6.22||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 20.||6.22|2.45|<0.0001
72494894|NCT00848354|144519124|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.94|||<|0.0001|TWO_SIDED|95.0|3.13|7.78||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 24.||7.78|3.13|<0.0001
72494895|NCT00848354|144519126|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.19||||0.1086|TWO_SIDED|95.0|0.66|40.9||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 2.||40.9|0.66|0.1086
72494896|NCT00848354|144519126|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.58||||0.0392|TWO_SIDED|95.0|1.04|12.3||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 4.||12.3|1.04|0.0392
72436995|NCT02477670|144387255|SUPERIORITY||SPCD Weighted OLS z-statistic|-0.76||||0.447|TWO_SIDED|95.0|-2.72|1.2|||Mixed Models Analysis|||Treatment differences in each stage were estimated by the MMRM.||1.2|-2.72|0.447
72436996|NCT02477670|144387256|SUPERIORITY||SPCD Weighted OLS z-statistic|-2.23||||0.026|TWO_SIDED|95.0|-4.19|-0.27|||Mixed Models Analysis|||Treatment differences in each stage were estimated by the MMRM.||-0.27|-4.19|0.026
72436997|NCT02477670|144387257|SUPERIORITY||SPCD Weighted OLS z-statistic|-1.62||||0.106|TWO_SIDED|95.0|-3.58|0.34|||Mixed Models Analysis|||Treatment differences in each stage were estimated by the MMRM.||0.34|-3.58|0.106
72436998|NCT02477670|144387258|SUPERIORITY||SPCD Weighted OLS z-statistic|1.78||||0.074|TWO_SIDED|95.0|-0.18|3.74|||Mixed Models Analysis|||Treatment differences in each stage were estimated by the MMRM.||3.74|-0.18|0.074
72436999|NCT02477670|144387259|SUPERIORITY||SPCD Weighted OLS z-statistic|-0.79||||0.427|TWO_SIDED|95.0|-2.75|1.17|||Mixed Models Analysis|||Treatment differences in each stage were estimated by the MMRM.||1.17|-2.75|0.427
72437000|NCT02477670|144387260|SUPERIORITY||SPCD Weighted OLS z-statistic|-1.91||||0.0566|TWO_SIDED|95.0|-3.87|0.05|||McNemar|||Treatment differences in each stage were estimated by the MMRM.||0.05|-3.87|0.0566
72437001|NCT02477670|144387261|SUPERIORITY||SPCD Weighted OLS z-statistic|-1.37||||0.17|TWO_SIDED|95.0|-3.33|0.59|||ANCOVA|||||0.59|-3.33|0.1700
72437002|NCT02477670|144387262|SUPERIORITY||SPCD Weighted OLS z-statistic|0.53||||0.595|TWO_SIDED|95.0|-1.43|2.49|||Mixed Models Analysis|||Treatment differences in each stage were estimated by the MMRM.||2.49|-1.43|0.595
72437003|NCT02477670|144387263|SUPERIORITY||SPCD Weighted OLS z-statistic|2.284||||0.022|TWO_SIDED|95.0|0.324|4.244|||ANCOVA|||||4.244|0.324|0.022
72437004|NCT02477670|144387264|SUPERIORITY||SPCD Weighted OLS z-statistic|-0.17||||0.862|TWO_SIDED|95.0|-2.13|1.79|||ANCOVA|||||1.79|-2.13|0.862
72437005|NCT02477670|144387265|SUPERIORITY||SPCD Weighted OLS z-statistic|-1.149||||0.251|TWO_SIDED|95.0|-3.109|0.811|||ANCOVA|||||0.811|-3.109|0.251
72384811|NCT00734474|144277429|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.05|||<|0.001|TWO_SIDED|95.0|-1.21|-0.88||Comparison at 26 weeks. P-value adjusted for multiplicity based on tree-gatekeeping strategy. To determine significance, p-value is compared to the family-wise 1-sided Type I error of 0.025. The confidence interval is not adjusted for multiplicity.|ANCOVA|||Superiority analysis||-0.88|-1.21|<0.001
72437006|NCT02477670|144387266|SUPERIORITY||SPCD Weighted OLS z-statistic|-1.159||||0.246|TWO_SIDED|95.0|-3.119|0.801|||ANCOVA|||||0.801|-3.119|0.246
72437007|NCT02477670|144387267|SUPERIORITY||SPCD Weighted OLS z-statistic|0.231||||0.818|TWO_SIDED|95.0|-1.729|2.191|||ANCOVA|||||2.191|-1.729|0.818
72384812|NCT00734474|144277429|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.64|||<|0.001|TWO_SIDED|95.0|-0.81|-0.48||Comparison at 26 weeks. One-sided raw p-value with no adjustment for multiplicity.|ANCOVA|||||-0.48|-0.81|<0.001
72384813|NCT00734474|144277429|NON_INFERIORITY_OR_EQUIVALENCE|Family-wise Type I error rate was controlled by applying a gatekeeping strategy.|LS Mean Difference|-0.67|||<|0.001|TWO_SIDED|95.0|-0.84|-0.5||Comparison at 104 weeks. P-value adjusted for multiplicity based on tree-gatekeeping strategy. To determine significance, p-value is compared to the family-wise 1-sided Type I error of 0.025. The confidence interval is not adjusted for multiplicity.|ANCOVA|||||-0.50|-0.84|<0.001
72384814|NCT00734474|144277429|NON_INFERIORITY_OR_EQUIVALENCE|Family-wise Type I error rate controlled by applying gatekeeping strategy.|LS Mean Difference|-0.39|||<|0.001|TWO_SIDED|95.0|-0.56|-0.22||Comparison at 104 weeks. P-value adjusted for multiplicity based on tree-gatekeeping strategy. To determine significance, p-value is compared to the family-wise 1-sided Type I error of 0.025. The confidence interval is not adjusted for multiplicity.|ANCOVA|||||-0.22|-0.56|<0.001
72437008|NCT02477670|144387268|SUPERIORITY||SPCD Weighted OLS z-statistic|-0.04||||0.968|TWO_SIDED|95.0|-2.0|1.92|||ANCOVA|||||1.92|-2.00|0.968
72437009|NCT02477670|144387269|SUPERIORITY||SPCD Weighted OLS z-statistic|-0.306||||0.76|TWO_SIDED|95.0|-2.266|1.654|||ANCOVA|||||1.654|-2.266|0.760
72437010|NCT02477670|144387270|SUPERIORITY||SPCD Weighted OLS z-statistic|1.243||||0.214|TWO_SIDED|95.0|-0.717|3.203|||ANCOVA|||||3.203|-0.717|0.214
72437011|NCT02477670|144387271|SUPERIORITY|||||||0.071|||||||SPCD 1 degree of freedom score test|||||||0.071
72437012|NCT02477670|144387272|SUPERIORITY||SPCD Weighted OLS z-statistic|0.951||||-0.06|TWO_SIDED|95.0|-1.009|2.911|||Mixed Models Analysis|||Treatment differences in each stage were estimated by the MMRM.||2.911|-1.009|-0.06
72437013|NCT00831272|144387292|SUPERIORITY_OR_OTHER|||||||0.32|||||||Generalized Estimating Equation|||||||0.32
72437014|NCT02694978|144387310|NON_INFERIORITY|The non-inferiority margin of 2.64% was used for the primary endpoint statistical analysis.|Treatment difference|-0.1||||0.0001|TWO_SIDED|95.0|-0.8|0.61|||Wald|The p-value was calculated using the Wald large sample assumption.||"Statistical analysis was only performed on composite reaction data (that is, the Any TE moderate to severe hypersensitivity rxn row in the data table)."||0.61|-0.80|0.0001
72437015|NCT00818454|144387316|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||MMRM ANCOVA|||||||<0.0001
72437016|NCT00818454|144387317|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||MMRM ANCOVA|||||||<0.0001
72384815|NCT00734474|144277429|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.67|||<|0.001|TWO_SIDED|95.0|-0.84|-0.5||Comparison at 104 weeks. P-value adjusted for multiplicity based on tree-gatekeeping strategy. To determine significance, p-value is compared to the family-wise 1-sided Type I error of 0.025. The confidence interval is not adjusted for multiplicity.|ANCOVA|||Superiority analysis||-0.50|-0.84|<0.001
72384816|NCT00734474|144277429|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.39|||<|0.001|TWO_SIDED|95.0|-0.56|-0.22||Comparison at 104 weeks. P-value adjusted for multiplicity based on tree-gatekeeping strategy. To determine significance, p-value is compared to the family-wise 1-sided Type I error of 0.025. The confidence interval is not adjusted for multiplicity.|ANCOVA|||Superiority analysis||-0.22|-0.56|<0.001
72384817|NCT00734474|144277431|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.89|||<|0.001|TWO_SIDED|95.0|-2.27|-1.51|||Mixed Models Analysis|Comparison at 26 weeks.||||-1.51|-2.27|<0.001
72384818|NCT00734474|144277431|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.48|||<|0.001|TWO_SIDED|95.0|-1.85|-1.1||Comparison at 26 weeks.|Mixed Models Analysis|||||-1.10|-1.85|<0.001
72437017|NCT00818454|144387318|SUPERIORITY_OR_OTHER|||||||0.159|||||||MMRM ANCOVA|||||||0.159
72437018|NCT00818454|144387319|SUPERIORITY_OR_OTHER|||||||0.8278|||||||MMRM ANCOVA|||||||0.8278
72437019|NCT00818454|144387320|SUPERIORITY_OR_OTHER|||||||0.5098|||||||MMRM ANCOVA|||||||0.5098
72437020|NCT00818454|144387321|SUPERIORITY_OR_OTHER|||||||0.6591|||||||MMRM ANCOVA|||||||0.6591
72437021|NCT00818454|144387322|SUPERIORITY_OR_OTHER|||||||0.3631|||||||MMRM ANCOVA|||||||0.3631
72437022|NCT00818454|144387323|NON_INFERIORITY_OR_EQUIVALENCE|Enter additional comments here, if non-inferiority or equivalence analysis||||||0.6787|||||||MMRM ANCOVA|||||||0.6787
72437023|NCT00818454|144387324|SUPERIORITY_OR_OTHER|||||||0.0001||95.0|||||Mixed Models Analysis|Adjusted for baseline, period, week, and treatment by week interaction||||||0.0001
72437024|NCT00818454|144387325|SUPERIORITY_OR_OTHER|||||||0.0003||95.0|||||Mixed Models Analysis|Adjusted for baseline, period, week, and treatment by week interaction||||||0.0003
72437025|NCT02680457|144387369|SUPERIORITY|||||||0.63|||||||Wilcoxon (Mann-Whitney)|||||||0.630
72437026|NCT02680457|144387370|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||||||1.00
72437027|NCT00854906|144387408|NON_INFERIORITY_OR_EQUIVALENCE|This was a pilot study. Therefore, no formal power analyses were performed.|Mean Difference (Final Values)|0.666|STANDARD_DEVIATION|3.6||0.074|TWO_SIDED|95.0|-0.069|1.401|||t-test, 2 sided|||The paired T-test was used to compare mean KTBUT and mean FTBUT.||1.401|-0.069|0.074
72437028|NCT00854906|144387409|NON_INFERIORITY_OR_EQUIVALENCE|The analysis will evaluate the association between OSDI with KTBUT.|Pearson's Correlation, r|-0.34||||0.093|ONE_SIDED||||||Pearson's correlation|||A correlation was performed between ODSI questionnaire results and each participant's KTBUT.||||0.093
72437029|NCT00854906|144387409|SUPERIORITY_OR_OTHER||Pearson's Correlation, r|-0.26||||0.216|||||||Pearson's Correlation|||A correlation was performed between ODSI questionnaire results and each participant's FTBUT.||||0.216
72558435|NCT00112437|144646474|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|2.78|||<=|0.001|TWO_SIDED|95.0|1.82|3.73||Significance for the primary endpoint was achieved through stepdown trend-test, the highest dose group was removed and the test was repeated until lack of significance was observed.|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The primary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on lumbar spine BMD compared to placebo over 12 months. The primary hypothesis states that odanacatib will increase lumbar spine BMD compared to placebo over 12 months.||3.73|1.82|<=0.001
72558436|NCT00112437|144646474|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|1.63||||0.003|TWO_SIDED|95.0|0.68|2.59||Significance for the primary endpoint was achieved through stepdown trend-test, the highest dose group was removed and the test was repeated until lack of significance was observed.|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The primary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on lumbar spine BMD compared to placebo over 12 months. The primary hypothesis states that odanacatib will increase lumbar spine BMD compared to placebo over 12 months.||2.59|0.68|0.003
72558437|NCT00112437|144646474|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-0.49||||0.343|TWO_SIDED|95.0|-1.44|0.46||Significance for the primary endpoint was achieved through stepdown trend-test, the highest dose group was removed and the test was repeated until lack of significance was observed.|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The primary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on lumbar spine BMD compared to placebo over 12 months. The primary hypothesis states that odanacatib will increase lumbar spine BMD compared to placebo over 12 months.||0.46|-1.44|0.343
72558438|NCT00112437|144646475|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|5.67|||<=|0.001|TWO_SIDED|95.0|4.32|7.02||Significance for the primary endpoint was achieved through stepdown trend-test, the highest dose group was removed and the test was repeated until lack of significance was observed.|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The primary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on lumbar spine BMD compared to placebo over 24 months. The primary hypothesis states that odanacatib will increase lumbar spine BMD compared to placebo over 24 months.||7.02|4.32|<=0.001
72558439|NCT00112437|144646475|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|4.45|||<=|0.001|TWO_SIDED|95.0|3.15|5.76||Significance for the primary endpoint was achieved through stepdown trend-test, the highest dose group was removed and the test was repeated until lack of significance was observed.|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The primary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on lumbar spine BMD compared to placebo over 24 months. The primary hypothesis states that odanacatib will increase lumbar spine BMD compared to placebo over 24 months.||5.76|3.15|<=0.001
72558440|NCT00112437|144646475|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|3.39|||<=|0.001|TWO_SIDED|95.0|2.06|4.73||Significance for the primary endpoint was achieved through stepdown trend-test, the highest dose group was removed and the test was repeated until lack of significance was observed.|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The primary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on lumbar spine BMD compared to placebo over 24 months. The primary hypothesis states that odanacatib will increase lumbar spine BMD compared to placebo over 24 months.||4.73|2.06|<=0.001
72558441|NCT00112437|144646475|SUPERIORITY_OR_OTHER||Difference in Least Square Means|-0.84||||0.218||95.0|-2.19|0.51||Significance for the primary endpoint was achieved through stepdown trend-test, the highest dose group was removed and the test was repeated until lack of significance was observed.|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The primary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on lumbar spine BMD compared to placebo over 24 months. The primary hypothesis states that odanacatib will increase lumbar spine BMD compared to placebo over 24 months.||0.51|-2.19|0.218
72558442|NCT00112437|144646476|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|2.49|||<=|0.001|TWO_SIDED|95.0|1.62|3.35||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through a stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on total hip BMD compared to placebo over 12 months. The secondary hypothesis states that odanacatib will increase total hip BMD compared to placebo over 12 months.||3.35|1.62|<=0.001
72558443|NCT00112437|144646476|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|2.06|||<=|0.001|TWO_SIDED|95.0|1.2|2.93||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through a stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on total hip BMD compared to placebo over 12 months. The secondary hypothesis states that odanacatib will increase total hip BMD compared to placebo over 12 months.||2.93|1.20|<=0.001
72494897|NCT00848354|144519126|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.27|||<|0.0001|TWO_SIDED|95.0|2.04|13.6||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 8.||13.6|2.04|<0.0001
72494898|NCT00848354|144519126|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.69|||<|0.0001|TWO_SIDED|95.0|2.39|13.6||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 12.||13.6|2.39|<0.0001
72494899|NCT00848354|144519126|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.78|||<|0.0001|TWO_SIDED|95.0|2.02|7.09||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 16.||7.09|2.02|<0.0001
72494900|NCT00848354|144519126|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.65|||<|0.0001|TWO_SIDED|95.0|2.02|6.6||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 20.||6.60|2.02|<0.0001
72494901|NCT00848354|144519126|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.2|||<|0.0001|TWO_SIDED|95.0|2.36|7.46||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 24.||7.46|2.36|<0.0001
72494902|NCT00848354|144519128|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-values. ANCOVA was ran at each time-point shown, however as p-values obtained were identical, only one p-value is presented (which is applicable to each time-point - Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 - independently).||||<0.0001
72494903|NCT00848354|144519130|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.23|||<|0.0001|TWO_SIDED|95.0|3.88|10.0||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value.||10.00|3.88|<0.0001
72494904|NCT00848354|144519131|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|7.79|||<|0.0001|TWO_SIDED|95.0|3.49|17.39||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value.||17.39|3.49|<0.0001
72494905|NCT00848354|144519132|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.5|||<|0.0001|TWO_SIDED|95.0|2.24|5.46||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 2.||5.46|2.24|<0.0001
72384819|NCT00734474|144277431|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.48||||0.012|TWO_SIDED|95.0|-0.86|-0.11||Comparison at 26 weeks.|Mixed Models Analysis|||||-0.11|-0.86|0.012
72494906|NCT00848354|144519132|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.99|||<|0.0001|TWO_SIDED|95.0|2.91|8.55||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 4.||8.55|2.91|<0.0001
72384820|NCT00734474|144277431|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.47|||<|0.001|TWO_SIDED|95.0|-1.82|-1.13||Comparison at 52 weeks.|Mixed Models Analysis|||||-1.13|-1.82|<0.001
72437030|NCT01786564|144387420|OTHER|This is cross-sectional analysis in a single group.|Regression Coefficient|-0.075||||0.13|TWO_SIDED|95.0|-0.173|0.023||Unadjusted association. A priori p value of .05 was selected for statistical significance.|Regression, Linear|||The cross-sectional association between habitual sleep duration and oral disposition index was analyzed.||.023|-.173|.13
72437031|NCT01786564|144387420|OTHER|This is cross-sectional analysis|Regression Coefficient|0.12||||0.83|TWO_SIDED|95.0|-0.95|1.19||Unadjusted association. P value of .05 was selected a priori as statistical significance|Regression, Linear|Unadjusted.||The cross-sectional association between habitual sleep quality (sleep percentage) and oral disposition index was analyzed.||1.19|-0.95|.83
72618773|NCT01026038|144768112|SUPERIORITY_OR_OTHER||Percent Difference|0.1|||||TWO_SIDED|95.0|-4.8|7.5||||||Serotype 19F: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 13vPnC/13vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/13vPnC/13vPnC along with exact 2-sided 95% CI.||7.5|-4.8|
72437032|NCT01786564|144387420|OTHER|This is cross-sectional analysis in a single group.|Regression Coefficient|-0.05||||0.39|TWO_SIDED|95.0|-0.166|0.66||Unadjusted association. A priori p value of .05 was selected for statistical significance.|Regression, Linear|Unadjusted||The cross-sectional association between amount of Stage 3 sleep and oral disposition index was analyzed.||0.66|-.166|.39
72437033|NCT01786564|144387420|OTHER|Unadjusted association. P value of .05 was selected a priori as statistical significance|Regression Coefficient|-0.058||||0.11|TWO_SIDED|95.0|-0.129|0.014||Unadjusted association. P value of .05 was selected a priori as statistical significance|Regression, Linear|Unadjusted association.||The cross-sectional association between amount of REM sleep and oral disposition index was analyzed.||.014|-.129|.11
72437034|NCT01924767|144387441|SUPERIORITY_OR_OTHER||Geometric Mean of ratio|43.661|||||TWO_SIDED|95.0|27.52|69.269|||Regression, Linear|||This was non-confirmatory testing, dose proportionality of dose from 2.5mg to 100mg for Cmax (single dose) was analysed.||69.269|27.520|
72437035|NCT01924767|144387441|SUPERIORITY_OR_OTHER||Geometric Mean of ratio|31.234|||||TWO_SIDED|95.0|12.193|80.011|||Regression, Linear|||This was non-confirmatory testing, dose proportionality of dose from 2.5mg to 100mg for Cmax,ss (Multiple dose) was analysed.||80.011|12.193|
72384821|NCT00734474|144277431|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.73|||<|0.001|TWO_SIDED|95.0|-1.07|-0.39||Comparison at 52 weeks.|Mixed Models Analysis|||||-0.39|-1.07|<0.001
72384822|NCT00734474|144277431|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.51|||<|0.001|TWO_SIDED|95.0|-1.93|-1.1||Comparison at 104 weeks.|Mixed Models Analysis|||||-1.10|-1.93|<0.001
72384823|NCT00734474|144277431|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.92|||<|0.001|TWO_SIDED|95.0|-1.33|-0.51||Comparison at 104 weeks.|Mixed Models Analysis|||||-0.51|-1.33|<0.001
72384824|NCT00734474|144277432|SUPERIORITY_OR_OTHER||LS Mean Difference|18.51||||0.095|TWO_SIDED|95.0|-3.25|40.28||Comparison at 26 weeks.|Mixed Models Analysis|||||40.28|-3.25|0.095
72384825|NCT00734474|144277432|SUPERIORITY_OR_OTHER||LS Mean Difference|17.08||||0.121|TWO_SIDED|95.0|-4.54|38.69||Comparison at 26 weeks.|Mixed Models Analysis|||||38.69|-4.54|0.121
72437036|NCT01924767|144387442|SUPERIORITY_OR_OTHER||Geometric mean of ratio|49.707|||||TWO_SIDED|95.0|33.49|73.776|||Regression, Linear|||This was non-confirmatory testing, dose proportionality of dose from 2.5mg to 100mg for AUC (0-infinity, single dose) was analysed.||73.776|33.490|
72437037|NCT01924767|144387442|SUPERIORITY_OR_OTHER||Geometric mean of ratio|37.632|||||TWO_SIDED|95.0|15.429|91.789|||Regression, Linear|||This was non confirmatory testing, dose proportionality of dose from 2.5mg to 100mg for AUC (0-infinity, at steady state, day 9) was analysed.||91.789|15.429|
72437038|NCT01924767|144387453|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|37645.43||||0.0067|TWO_SIDED|95.0|11021.57|64269.3||This was non-confirmatory testing.|ANCOVA|The baseline value has been used a continuous covariate.||The mean change from baseline (day -2) to day 8 and comparisons to placebo for Urine Glucose Excretion (AE(0-24)).||64269.30|11021.57|0.0067
72437039|NCT01924767|144387453|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|82898.2|||<|0.0001|TWO_SIDED|95.0|55344.83|110451.6||This was non-confirmatory testing.|ANCOVA|The baseline value has been used a continuous covariate.|Mean difference to placebo is calculated.|The mean change from baseline (day -2) to day 8 and comparisons to placebo for Urine Glucose Excretion (AE(0-24)).||110451.6|55344.83|<0.0001
72494907|NCT00848354|144519132|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.94|||<|0.0001|TWO_SIDED|95.0|2.93|12.02||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 8.||12.02|2.93|<0.0001
72494908|NCT00848354|144519132|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.57|||<|0.0001|TWO_SIDED|95.0|2.27|9.21||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 12.||9.21|2.27|<0.0001
72494909|NCT00848354|144519132|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.08|||<|0.0001|TWO_SIDED|95.0|2.74|13.48||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 16.||13.48|2.74|<0.0001
72494910|NCT00848354|144519132|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.86|||<|0.0001|TWO_SIDED|95.0|3.0|15.72||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 20.||15.72|3.00|<0.0001
72494911|NCT00848354|144519132|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|7.64|||<|0.0001|TWO_SIDED|95.0|3.74|15.63||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 24.||15.63|3.74|<0.0001
72494912|NCT00848354|144519134|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.15|||<|0.0001|TWO_SIDED|95.0|2.04|4.86||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 2.||4.86|2.04|<0.0001
72494913|NCT00848354|144519134|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.41|||<|0.0001|TWO_SIDED|95.0|2.85|6.82||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 4.||6.82|2.85|<0.0001
72494914|NCT00848354|144519134|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.99|||<|0.0001|TWO_SIDED|95.0|2.5|6.38||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 8.||6.38|2.50|<0.0001
72494915|NCT00848354|144519134|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.9|||<|0.0001|TWO_SIDED|95.0|2.37|6.41||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 12.||6.41|2.37|<0.0001
72494916|NCT00848354|144519134|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.58|||<|0.0001|TWO_SIDED|95.0|3.19|9.76||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 16.||9.76|3.19|<0.0001
72494917|NCT00848354|144519134|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.49|||<|0.0001|TWO_SIDED|95.0|3.16|9.52||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 20.||9.52|3.16|<0.0001
72437040|NCT01924767|144387453|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|79982.89|||<|0.0001|TWO_SIDED|95.0|53087.22|106878.6||This was non-confirmatory testing.|ANCOVA|The baseline value has been used a continuous covariate.|Mean Difference to placebo is calculated.|The mean change from baseline (day -2) to day 8 and comparisons to placebo for Urine Glucose Excretion (AE(0-24)).||106878.6|53087.22|<0.0001
72437041|NCT01924767|144387453|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|91306.96|||<|0.0001|TWO_SIDED|95.0|64685.41|117928.5||This was non-confirmatory testing.|ANCOVA|The baseline value has been used a continuous covariate.|Mean Difference to placebo was calculated|The mean change from baseline (day -2) to day 8 and comparisons to placebo for Urine Glucose Excretion (AE(0-24)).||117928.5|64685.41|<0.0001
72437042|NCT01924767|144387454|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.456||||0.0449|TWO_SIDED|95.0|-30.543|-0.369||This was non-confirmatory testing.|ANCOVA|The baseline value has been used a continuous covariate.|Mean difference to placebo was calculated.|The mean percent decrease in Mean daily glucose from baseline with treatment compared with placebo from baseline -2 to day 8||-0.369|-30.543|0.0449
72494918|NCT00848354|144519134|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.59|||<|0.0001|TWO_SIDED|95.0|3.87|11.21||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 24.||11.21|3.87|<0.0001
72494919|NCT00848354|144519136|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.52|||<|0.0001|TWO_SIDED|95.0|2.3|5.4||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 2.||5.40|2.30|<0.0001
72437043|NCT01924767|144387454|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-23.467||||0.0042|TWO_SIDED|95.0|-39.085|-7.848||This was non-confirmatory testing.|ANCOVA|The baseline value has been used a continuous covariate.|Mean difference to placebo was calculated.|The mean percent decrease in Mean daily glucose from baseline with treatment compared with placebo from baseline -2 to day 8||-7.848|-39.085|0.0042
72384826|NCT00734474|144277432|SUPERIORITY_OR_OTHER||LS Mean Difference|15.41||||0.167|TWO_SIDED|95.0|-6.47|37.29||Comparison at 26 weeks.|Mixed Models Analysis|||||37.29|-6.47|0.167
72437044|NCT01924767|144387454|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.956||||0.0521|TWO_SIDED|95.0|-30.057|0.145||This was non-confirmatory testing.|ANCOVA|The baseline value has been used a continuous covariate.|Mean difference to placebo was calculated.|The mean percent decrease in Mean daily glucose from baseline with treatment compared with placebo from baseline -2 to day 8||0.145|-30.057|0.0521
72384827|NCT00734474|144277432|SUPERIORITY_OR_OTHER||LS Mean Difference|6.38||||0.43|TWO_SIDED|95.0|-9.49|22.26||Comparison at 52 weeks.|Mixed Models Analysis|||||22.26|-9.49|0.430
72437045|NCT01924767|144387454|SUPERIORITY_OR_OTHER||Difference to placebo|-10.602||||0.1676|TWO_SIDED|95.0|-25.848|4.644||This was non-confirmatory testing.|ANCOVA|The baseline value has been used a continuous covariate.|Mean difference to placebo was calculated|The mean percent decrease in Mean daily glucose from baseline with treatment compared with placebo from baseline -2 to day 8||4.644|-25.848|0.1676
72437046|NCT01924767|144387455|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.269||||0.2239|TWO_SIDED|95.0|-19.162|4.624||This was non-confirmatory testing.|ANCOVA|The baseline value has been used a continuous covariate.|Mean difference to placebo was calculated.|The mean percent change in Fasting Plasma Glucose from baseline with treatment compared with placebo from baseline -2 to day 8||4.624|-19.162|0.2239
72437047|NCT01924767|144387455|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.844||||0.0421||95.0|-25.205|-0.484||This was non-confirmatory testing.|ANCOVA|The baseline value has been used a continuous covariate.|Mean difference to placebo was calculated|The mean percent change in Fasting Plasma Glucose from baseline with treatment compared with placebo from baseline -2 to day 8||-0.484|-25.205|0.0421
72384828|NCT00734474|144277432|SUPERIORITY_OR_OTHER||LS Mean Difference|8.77||||0.273|TWO_SIDED|95.0|-6.94|24.47||Comparison at 52 weeks.|Mixed Models Analysis|||||24.47|-6.94|0.273
72384829|NCT00734474|144277432|SUPERIORITY_OR_OTHER||LS Mean Difference|11.07||||0.291|TWO_SIDED|95.0|-9.49|31.64||Comparison at 104 weeks.|Mixed Models Analysis|||||31.64|-9.49|0.291
72384830|NCT00734474|144277432|SUPERIORITY_OR_OTHER||LS Mean Difference|21.28||||0.039|TWO_SIDED|95.0|1.03|41.53||Comparison at 104 weeks.|Mixed Models Analysis|||||41.53|1.03|0.039
72437048|NCT01924767|144387455|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.719||||0.6527|TWO_SIDED|95.0|-14.842|9.403||This was non-confirmatory testing.|ANCOVA|The baseline value has been used a continuous covariate.|Mean difference to placebo was calculated.|The mean percent change in Fasting Plasma Glucose from baseline with treatment compared with placebo from baseline -2 to day 8||9.403|-14.842|0.6527
72437049|NCT01924767|144387455|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.998||||0.1318|TWO_SIDED|95.0|-20.818|2.822||This was non-confirmatory testing.|ANCOVA|The baseline value has been used a continuous covariate.|Mean difference to placebo was calculated.|The mean percent change in Fasting Plasma Glucose from baseline with treatment compared with placebo from baseline -2 to day 8||2.822|-20.818|0.1318
72437050|NCT00723450|144387484|SUPERIORITY_OR_OTHER|||||||0.0717||95.0|||||Log Rank|A stratified log rank test was performed where the stratification factor was the index mood state at Screen visit.||||||0.0717
72437051|NCT00612586|144387506|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8956||||||One sided|Log Rank|||||||0.8956
72437052|NCT00612586|144387507|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9865||||||One-sided|Log Rank|||||||0.9865
72437053|NCT02314117|144387514|SUPERIORITY||Hazard Ratio (HR)|0.753|||||TWO_SIDED|95.0|0.607|0.935||||||||0.935|0.607|
72437054|NCT02314117|144387515|SUPERIORITY||Hazard Ratio (HR)|0.962|||||TWO_SIDED|95.0|0.801|1.156||||||||1.156|0.801|
72384831|NCT00734474|144277434|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.7|||<|0.001|TWO_SIDED|95.0|-2.27|-1.14||Comparison at 26 weeks.|ANCOVA|||||-1.14|-2.27|<0.001
72384832|NCT00734474|144277434|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.16|||<|0.001|TWO_SIDED|95.0|-1.73|-0.6||Comparison at 26 weeks.|ANCOVA|||||-0.60|-1.73|<0.001
72384833|NCT00734474|144277434|SUPERIORITY_OR_OTHER||LS Mean Difference|0.02||||0.953|TWO_SIDED|95.0|-0.54|0.58||Comparison at 26 weeks.|ANCOVA|||||0.58|-0.54|0.953
72384834|NCT00734474|144277434|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.5|||<|0.001|TWO_SIDED|95.0|-2.08|-0.92||Comparison at 52 weeks.|ANCOVA|||||-0.92|-2.08|<0.001
72384835|NCT00734474|144277434|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.07|||<|0.001|TWO_SIDED|95.0|-1.65|-0.48||Comparison at 52 weeks.|ANCOVA|||||-0.48|-1.65|<0.001
72384836|NCT00734474|144277434|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.14|||<|0.001|TWO_SIDED|95.0|-1.78|-0.49||Comparison at 104 weeks.|ANCOVA|||||-0.49|-1.78|<0.001
72384837|NCT00734474|144277434|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.64||||0.054|TWO_SIDED|95.0|-1.29|0.01||Comparison at 104 weeks.|ANCOVA|||||0.01|-1.29|0.054
72384838|NCT00734474|144277436|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.69|||<|0.001|TWO_SIDED|95.0|-2.45|-0.93||Comparison at 26 weeks.|Mixed Models Analysis|||||-0.93|-2.45|<0.001
72384839|NCT00734474|144277436|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.58||||0.133|TWO_SIDED|95.0|-1.34|0.18||Comparison at 26 weeks.|Mixed Models Analysis|||||0.18|-1.34|0.133
72384840|NCT00734474|144277436|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.25||||0.512|TWO_SIDED|95.0|-1.01|0.5||Comparison at 26 weeks.|Mixed Models Analysis|||||0.50|-1.01|0.512
72384841|NCT00734474|144277436|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.46|||<|0.001|TWO_SIDED|95.0|-2.23|-0.69||Comparison at 52 weeks.|Mixed Models Analysis|||||-0.69|-2.23|<0.001
72384842|NCT00734474|144277436|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.59||||0.128|TWO_SIDED|95.0|-1.36|0.17||Comparison at 52 weeks.|Mixed Models Analysis|||||0.17|-1.36|0.128
72437055|NCT02314117|144387516|SUPERIORITY||Hazard Ratio (HR)|0.926|||||TWO_SIDED|95.0|0.774|1.108||||||||1.108|0.774|
72437056|NCT02314117|144387519|SUPERIORITY||Hazard Ratio (HR)|0.699|||||TWO_SIDED|95.0|0.569|0.859||||||||0.859|0.569|
72437057|NCT02314117|144387520|SUPERIORITY||Hazard Ratio (HR)|0.657|||||TWO_SIDED|95.0|0.499|0.866||||||||0.866|0.499|
72437058|NCT02314117|144387521|SUPERIORITY||Hazard Ratio (HR)|1.013|||||TWO_SIDED|95.0|0.77|1.332||||||||1.332|0.770|
72437059|NCT02314117|144387523|SUPERIORITY||Hazard Ratio (HR)|1.117|||||TWO_SIDED|95.0|0.79|1.58||||||||1.580|0.790|
72437060|NCT00530842|144387527|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.087|STANDARD_ERROR_OF_MEAN|0.044||0.0482|TWO_SIDED|95.0|-0.174|-0.001|||ANOVA|ANOVA with fixed terms for sequence, treatment, and period and random term for subject within sequence.||||-0.001|-0.174|0.0482
72437061|NCT00530842|144387528|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|3.0||||0.3407|TWO_SIDED|95.0|-9.5|27.5|||Wilcoxon signed-rank test||The confidence interval was determined by Hodges-Lehmann method.|||27.5|-9.5|0.3407
72437062|NCT00922207|144387586|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.9||||0.6853|TWO_SIDED|95.0|0.46|1.75|||Cochran-Mantel-Haenszel|||||1.75|0.46|0.6853
72437063|NCT00922207|144387586|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.66||||0.1977|TWO_SIDED|95.0|0.35|1.26|||Cochran-Mantel-Haenszel|||||1.26|0.35|0.1977
72437064|NCT00922207|144387586|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.74||||0.2916|TWO_SIDED|95.0|0.39|1.38|||Cochran-Mantel-Haenszel|||||1.38|0.39|0.2916
72437065|NCT00922207|144387587|SUPERIORITY_OR_OTHER||Least Squares (LS) Mean Difference|0.34||||0.0353|TWO_SIDED|95.0|0.02|0.66|||ANCOVA|||Baseline||0.66|0.02|0.0353
72437066|NCT00922207|144387587|SUPERIORITY_OR_OTHER||LS Mean Difference|0.23||||0.1114|TWO_SIDED|95.0|-0.05|0.52|||ANCOVA|||Baseline||0.52|-0.05|0.1114
72437067|NCT00922207|144387587|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1||||0.515|TWO_SIDED|95.0|-0.42|0.21|||ANCOVA|||Baseline||0.21|-0.42|0.5150
72437068|NCT00922207|144387587|SUPERIORITY_OR_OTHER||LS Mean Difference|0.62|||<|0.001|TWO_SIDED|95.0|0.34|0.89|||ANCOVA|||Change at Week 4||0.89|0.34|<0.001
72437069|NCT00922207|144387587|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.92|||<|0.001|TWO_SIDED|95.0|-2.19|-1.65|||ANCOVA|||Change at Week 4||-1.65|-2.19|<0.001
72494920|NCT00848354|144519136|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.87|||<|0.0001|TWO_SIDED|95.0|3.07|7.71||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 4.||7.71|3.07|<0.0001
72494921|NCT00848354|144519136|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.0|||<|0.0001|TWO_SIDED|95.0|2.98|8.41||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 8.||8.41|2.98|<0.0001
72437070|NCT00922207|144387587|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.54|||<|0.001|TWO_SIDED|95.0|-2.81|-2.27|||ANCOVA|||Change at Week 4||-2.27|-2.81|<0.001
72437071|NCT00922207|144387587|SUPERIORITY_OR_OTHER||LS Mean Difference|1.7|||<|0.001|TWO_SIDED|95.0|1.34|2.06|||ANCOVA|||Change at Week 8||2.06|1.34|<0.001
72437072|NCT00922207|144387587|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.55||||0.0071|TWO_SIDED|95.0|-0.95|-0.15|||ANCOVA|||Change at Week 8||-0.15|-0.95|0.0071
72437073|NCT00922207|144387587|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.26|||<|0.001|TWO_SIDED|95.0|-2.61|-1.9|||ANCOVA|||Change at Week 8||-1.90|-2.61|<0.001
72437074|NCT00922207|144387587|SUPERIORITY_OR_OTHER||LS Mean Difference|1.62|||<|0.001|TWO_SIDED|95.0|1.16|2.08|||ANCOVA|||Change at Week 16||2.08|1.16|<0.001
72494922|NCT00848354|144519136|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.4|||<|0.0001|TWO_SIDED|95.0|2.55|7.58||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 12.||7.58|2.55|<0.0001
72437075|NCT00922207|144387587|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.02||||0.9557|TWO_SIDED|95.0|-0.56|0.53|||ANCOVA|||Change at Week 16||0.53|-0.56|0.9557
72437076|NCT00922207|144387587|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.65|||<|0.001|TWO_SIDED|95.0|-2.15|-1.14|||ANCOVA|||Change at Week 16||-1.14|-2.15|<0.001
72437077|NCT00922207|144387587|SUPERIORITY_OR_OTHER||LS Mean Difference|0.73||||0.0094|TWO_SIDED|95.0|0.18|1.27|||ANCOVA|||Change at Week 28||1.27|0.18|0.0094
72437078|NCT00922207|144387587|SUPERIORITY_OR_OTHER||LS Mean Difference|0.51||||0.0943|TWO_SIDED|95.0|-0.09|1.11|||ANCOVA|||Change at Week 28||1.11|-0.09|0.0943
72437079|NCT00922207|144387587|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.23||||0.4354|TWO_SIDED|95.0|-0.82|0.35|||ANCOVA|||Change at Week 28||0.35|-0.82|0.4354
72437080|NCT00922207|144387587|SUPERIORITY_OR_OTHER||LS Mean Difference|0.36||||0.2509|TWO_SIDED|95.0|-0.26|0.98|||ANCOVA|||Change at Week 40||0.98|-0.26|0.2509
72437081|NCT00922207|144387587|SUPERIORITY_OR_OTHER||LS Mean Difference|0.67||||0.0429|TWO_SIDED|95.0|0.02|1.31|||ANCOVA|||Change at Week 40||1.31|0.02|0.0429
72437082|NCT00922207|144387587|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3||||0.3585|TWO_SIDED|95.0|-0.34|0.93|||ANCOVA|||Change at Week 40||0.93|-0.34|0.3585
72437083|NCT00922207|144387587|SUPERIORITY_OR_OTHER||LS Mean Difference|0.04||||0.9014|TWO_SIDED|95.0|-0.65|0.74|||ANCOVA|||Change at Week 52||0.74|-0.65|0.9014
72437084|NCT00922207|144387587|SUPERIORITY_OR_OTHER||LS Mean Difference|0.57||||0.1122|TWO_SIDED|95.0|-0.13|1.28|||ANCOVA|||Change at Week 52||1.28|-0.13|0.1122
72437085|NCT00922207|144387587|SUPERIORITY_OR_OTHER||LS Mean Difference|0.51||||0.1602|TWO_SIDED|95.0|-0.2|1.23|||ANCOVA|||Change at Week 52||1.23|-0.20|0.1602
72437086|NCT00922207|144387587|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.49||||0.1599|TWO_SIDED|95.0|-1.17|0.19|||ANCOVA|||Change at Week 64||0.19|-1.17|0.1599
72437087|NCT00922207|144387587|SUPERIORITY_OR_OTHER||LS Mean Difference|0.23||||0.5045|TWO_SIDED|95.0|-0.45|0.92|||ANCOVA|||Change at Week 64||0.92|-0.45|0.5045
72437088|NCT00922207|144387587|SUPERIORITY_OR_OTHER||LS Mean Difference|0.72||||0.0412|TWO_SIDED|95.0|0.03|1.41|||ANCOVA|||Change at Week 64||1.41|0.03|0.0412
72437089|NCT00922207|144387587|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.54||||0.1347|TWO_SIDED|95.0|-1.24|0.17|||ANCOVA|||Change at Week 76||0.17|-1.24|0.1347
72437090|NCT00922207|144387587|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3||||0.4027|TWO_SIDED|95.0|-0.41|1.01|||ANCOVA|||Change at Week 76||1.01|-0.41|0.4027
72437091|NCT00922207|144387587|SUPERIORITY_OR_OTHER||LS Mean Difference|0.81||||0.0311|TWO_SIDED|95.0|0.07|1.55|||ANCOVA|||Change at Week 76||1.55|0.07|0.0311
72437092|NCT00922207|144387587|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.36||||0.3183|TWO_SIDED|95.0|-1.07|0.35|||ANCOVA|||Change at Week 88||0.35|-1.07|0.3183
72494923|NCT00848354|144519136|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.81|||<|0.0001|TWO_SIDED|95.0|3.15|10.74||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 16.||10.74|3.15|<0.0001
72384843|NCT00734474|144277436|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.36||||0.005|TWO_SIDED|95.0|-2.3|-0.42||Comparison at 104 weeks.|Mixed Models Analysis|||||-0.42|-2.30|0.005
72384844|NCT00734474|144277436|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.54||||0.256|TWO_SIDED|95.0|-1.48|0.4||Comparison at 104 weeks.|Mixed Models Analysis|||||0.40|-1.48|0.256
72384845|NCT00734474|144277437|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|11.3|||<|0.001|TWO_SIDED|95.0|6.8|18.8||Comparison of HbA1c \<7.0% at 26 weeks.|Regression, Logistic|||||18.8|6.8|<0.001
72384846|NCT00734474|144277437|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|8.6|||<|0.001|TWO_SIDED|95.0|5.2|14.3||Comparison of HbA1c \<7.0% at 26 weeks.|Regression, Logistic|||||14.3|5.2|<0.001
72384847|NCT00734474|144277437|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.0|||<|0.001|TWO_SIDED|95.0|1.8|4.8||Comparison of HbA1c \<7.0% at 26 weeks.|Regression, Logistic|||||4.8|1.8|<0.001
72437093|NCT00922207|144387587|SUPERIORITY_OR_OTHER||LS Mean Difference|0.52||||0.1371|TWO_SIDED|95.0|-0.17|1.22|||ANCOVA|||Change at Week 88||1.22|-0.17|0.1371
72437094|NCT00922207|144387587|SUPERIORITY_OR_OTHER||LS Mean Difference|0.9||||0.0113|TWO_SIDED|95.0|0.21|1.6|||ANCOVA|||Change at Week 88||1.60|0.21|0.0113
72437095|NCT00922207|144387587|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.21||||0.5608|TWO_SIDED|95.0|-0.92|0.5|||ANCOVA|||Change at Week 100||0.50|-0.92|0.5608
72437096|NCT00922207|144387587|SUPERIORITY_OR_OTHER||LS Mean Difference|0.17||||0.6323|TWO_SIDED|95.0|-0.53|0.88|||ANCOVA|||Change at Week 100||0.88|-0.53|0.6323
72437097|NCT00922207|144387587|SUPERIORITY_OR_OTHER||LS Mean Difference|0.4||||0.2752|TWO_SIDED|95.0|-0.32|1.11|||ANCOVA|||Change at Week 100||1.11|-0.32|0.2752
72437098|NCT00922207|144387588|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.59||||0.6107|TWO_SIDED|95.0|0.26|9.71|||Cochran-Mantel-Haenszel|||Baseline||9.71|0.26|0.6107
72437099|NCT00922207|144387588|SUPERIORITY_OR_OTHER|||||||0.0788|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Baseline||||0.0788
72437100|NCT00922207|144387588|SUPERIORITY_OR_OTHER|||||||0.1761|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Baseline||||0.1761
72437101|NCT00922207|144387588|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.32||||0.7044|TWO_SIDED|95.0|0.34|5.09|||Cochran-Mantel-Haenszel|||Week 4||5.09|0.34|0.7044
72437102|NCT00922207|144387588|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.35||||0.0927|TWO_SIDED|95.0|0.61|46.76|||Cochran-Mantel-Haenszel|||Week 4||46.76|0.61|0.0927
72437103|NCT00922207|144387588|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.04||||0.1858|TWO_SIDED|95.0|0.44|36.89|||Cochran-Mantel-Haenszel|||Week 4||36.89|0.44|0.1858
72384848|NCT00734474|144277437|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.0|||<|0.001|TWO_SIDED|95.0|2.7|5.9||Comparison of HbA1c \<7.0% at 52 weeks.|Regression, Logistic|||||5.9|2.7|<0.001
72384849|NCT00734474|144277437|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.7|||<|0.001|TWO_SIDED|95.0|1.8|3.9||Comparison of HbA1c \<7.0% at 52 weeks.|Regression, Logistic|||||3.9|1.8|<0.001
72384850|NCT00734474|144277437|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.4|||<|0.001|TWO_SIDED|95.0|2.4|5.0||Comparison of HbA1c \<7.0% at 104 weeks.|Regression, Logistic|||||5.0|2.4|<0.001
72384851|NCT00734474|144277437|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.3|||<|0.001|TWO_SIDED|95.0|1.6|3.3||Comparison of HbA1c \<7.0% at 104 weeks.|Regression, Logistic|||||3.3|1.6|<0.001
72384852|NCT00734474|144277437|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|11.5|||<|0.001|TWO_SIDED|95.0|6.5|20.4||Comparison of HbA1c ≤6.5% at 26 weeks.|Regression, Logistic|||||20.4|6.5|<0.001
72384853|NCT00734474|144277437|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.0|||<|0.001|TWO_SIDED|95.0|2.8|8.8||Comparison of HbA1c ≤6.5% at 26 weeks.|Regression, Logistic|||||8.8|2.8|<0.001
72384854|NCT00734474|144277437|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.3||||0.005|TWO_SIDED|95.0|1.3|4.1||Comparison of HbA1c ≤6.5 at 26 weeks.|Regression, Logistic|||||4.1|1.3|0.005
72384855|NCT00734474|144277437|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.4|||<|0.001|TWO_SIDED|95.0|2.9|6.8||Comparison of HbA1c ≤6.5% at 52 weeks.|Regression, Logistic|||||6.8|2.9|<0.001
72384856|NCT00734474|144277437|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.3|||<|0.001|TWO_SIDED|95.0|1.5|3.5||Comparison of HbA1c ≤6.5% at 52 weeks.|Regression, Logistic|||||3.5|1.5|<0.001
72384857|NCT00734474|144277437|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.2|||<|0.001|TWO_SIDED|95.0|3.4|7.9||Comparison of HbA1c ≤6.5% at 104 weeks.|Regression, Logistic|||||7.9|3.4|<0.001
72384858|NCT00734474|144277437|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.4|||<|0.001|TWO_SIDED|95.0|1.5|3.7||Comparison of HbA1c ≤6.5% at 104 weeks.|Regression, Logistic|||||3.7|1.5|<0.001
72437104|NCT00922207|144387588|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.05||||0.9385|TWO_SIDED|95.0|0.33|3.38|||Cochran-Mantel-Haenszel|||Week 8||3.38|0.33|0.9385
72437105|NCT00922207|144387588|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.57||||0.5068|TWO_SIDED|95.0|0.43|5.77|||Cochran-Mantel-Haenszel|||Week 8||5.77|0.43|0.5068
72437106|NCT00922207|144387588|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.5||||0.5544|TWO_SIDED|95.0|0.41|5.5|||Cochran-Mantel-Haenszel|||Week 8||5.50|0.41|0.5544
72437107|NCT00922207|144387588|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.77||||0.651|TWO_SIDED|95.0|0.26|2.31|||Cochran-Mantel-Haenszel|||Week 16||2.31|0.26|0.6510
72437108|NCT00922207|144387588|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.59||||0.3192|TWO_SIDED|95.0|0.2|1.69|||Cochran-Mantel-Haenszel|||Week 16||1.69|0.20|0.3192
72437109|NCT00922207|144387588|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.76||||0.5818|TWO_SIDED|95.0|0.29|2.03|||Cochran-Mantel-Haenszel|||Week 16||2.03|0.29|0.5818
72437110|NCT00922207|144387588|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.05||||0.8796|TWO_SIDED|95.0|0.41|2.66|||Cochran-Mantel-Haenszel|||Week 28||2.66|0.41|0.8796
72437111|NCT00922207|144387588|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.64||||0.305|TWO_SIDED|95.0|0.27|1.52|||Cochran-Mantel-Haenszel|||Week 28||1.52|0.27|0.3050
72437112|NCT00922207|144387588|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.61||||0.2414|TWO_SIDED|95.0|0.26|1.44|||Cochran-Mantel-Haenszel|||Week 28||1.44|0.26|0.2414
72437113|NCT00922207|144387588|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.05||||0.8502|TWO_SIDED|95.0|0.5|2.22|||Cochran-Mantel-Haenszel|||Week 40||2.22|0.50|0.8502
72437114|NCT00922207|144387588|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.79||||0.5|TWO_SIDED|95.0|0.38|1.61|||Cochran-Mantel-Haenszel|||Week 40||1.61|0.38|0.5000
72437115|NCT00922207|144387588|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.75||||0.3882|TWO_SIDED|95.0|0.36|1.53|||Cochran-Mantel-Haenszel|||Week 40||1.53|0.36|0.3882
72558444|NCT00112437|144646476|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|1.67|||<=|0.001|TWO_SIDED|95.0|0.8|2.53||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through a stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on total hip BMD compared to placebo over 12 months. The secondary hypothesis states that odanacatib will increase total hip BMD compared to placebo over 12 months.||2.53|0.80|<=0.001
72558445|NCT00112437|144646476|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-0.75||||0.135|TWO_SIDED|95.0|-1.61|0.11||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through a stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on total hip BMD compared to placebo over 12 months. The secondary hypothesis states that odanacatib will increase total hip BMD compared to placebo over 12 months.||0.11|-1.61|0.135
72384859|NCT00942448|144277473|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|24.2|||<|0.001|||||||ANCOVA|||"The sample size calculation was based on a hypothesis of superiority of diclofenac HPBCD s.c. 25mg/ml and 50 mg/ml compared to Placebo with regard to the primary efficacy variable (PID at 1.5 hours following drug administration).~A sample size of 60 in each group had 95% power to detect a difference between diclofenac HPBCD s.c. 25 mg/ml and placebo in means of 15 mm, assuming that the common standard deviation was 22.5 and using a two group t-test with a 0.05 two-sided significance level."||||< 0.001
72384860|NCT00942448|144277473|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|25.1||||0.001|TWO_SIDED|95.0|18.4|31.7|||ANCOVA|||||31.7|18.4|0.001
72384861|NCT00942448|144277486|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|24.2|||<|0.001|TWO_SIDED|95.0|17.6|30.8|||ANCOVA|||"The sample size calculation was based on a hypothesis of superiority of diclofenac HPBCD s.c. 25mg/ml and 50 mg/ml compared to Placebo with regard to the primary efficacy variable (PID at 1.5 hours following drug administration).~A sample size of 60 in each group had 95% power to detect a difference between diclofenac HPBCD s.c. 25 mg/ml and placebo in means of 15 mm, assuming that the common standard deviation was 22.5 and using a two group t-test with a 0.05 two-sided significance level."||30.8|17.6|< 0.001
72384862|NCT00942448|144277486|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|25.1|||<|0.001|TWO_SIDED|95.0|18.4|31.7|||ANCOVA|||"The sample size calculation was based on a hypothesis of superiority of diclofenac HPBCD s.c. 25mg/ml and 50 mg/ml compared to Placebo with regard to the primary efficacy variable (PID at 1.5 hours following drug administration).~A sample size of 60 in each group had 95% power to detect a difference between diclofenac HPBCD s.c. 25 mg/ml and placebo in means of 15 mm, assuming that the common standard deviation was 22.5 and using a two group t-test with a 0.05 two-sided significance level."||31.7|18.4|<0.001
72384863|NCT02651467|144277517|SUPERIORITY_OR_OTHER||Difference of Least Square mean|-0.88|||<|0.0001|TWO_SIDED|95.0|-1.181|-0.584||From ANCOVA model with treatment as factor and baseline Schiff score as covariate.|ANCOVA||Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|For the Week 8 comparisons of the two Treatments against the Placebo Control, Dunnett's multiplicity adjustment is applied.||-0.584|-1.181|<0.0001
72384864|NCT02651467|144277517|SUPERIORITY_OR_OTHER||Diference of Least Square mean|-1.04|||<|0.0001|TWO_SIDED|95.0|-1.333|-0.738||From ANCOVA model with treatment as factor and baseline Schiff score as covariate.|ANCOVA||Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|For the Week 8 comparisons of the two Treatments against the control, Dunnett's multiplicity adjustment is applied.||-0.738|-1.333|<0.0001
72384865|NCT02651467|144277518|SUPERIORITY_OR_OTHER||Least Square Mean Difference|0.15||||0.2478||95.0|-0.107|0.413||From ANCOVA model with treatment as factor and baseline Schiff score as covariate.|ANCOVA||Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|||0.413|-0.107|0.2478
72437116|NCT00922207|144387588|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.99||||0.9584|TWO_SIDED|95.0|0.5|1.99|||Cochran-Mantel-Haenszel|||Week 52||1.99|0.50|0.9584
72437117|NCT00922207|144387588|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.69||||0.2576|TWO_SIDED|95.0|0.35|1.34|||Cochran-Mantel-Haenszel|||Week 52||1.34|0.35|0.2576
72384866|NCT01890746|144277534|OTHER|Bioequivalence|Ratio of geometric means (%)|114.9|||||TWO_SIDED|90.0|99.5|132.7||||||||132.7|99.5|
72384867|NCT01890746|144277535|OTHER|Bioequivalence|Ratio of geometric means (%)|105.2|||||TWO_SIDED|90.0|97.1|114.0||||||||114.0|97.1|
72384868|NCT01890746|144277536|OTHER|Bioequivalence|Ratio of geometric means (%)|92.0|||||TWO_SIDED|90.0|76.8|110.2||||||||110.2|76.8|
72384869|NCT01890746|144277537|OTHER|Bioequivalence|Ratio of geometric means (%)|101.8|||||TWO_SIDED|90.0|92.9|111.7||||||||111.7|92.9|
72384870|NCT01890746|144277538|OTHER|Bioequivalence|Ratio of geometric means (%)|121.0|||||TWO_SIDED|90.0|102.5|142.8||||||||142.8|102.5|
72384871|NCT01890746|144277539|OTHER|Bioequivalence|Ratio of geometric means (%)|106.5|||||TWO_SIDED|90.0|95.0|119.4||||||||119.4|95.0|
72384872|NCT01890746|144277540|OTHER|Bioequivalence|Ratio of geometric means (%)|91.7|||||TWO_SIDED|90.0|76.5|110.0||||||||110.0|76.5|
72384873|NCT01890746|144277541|OTHER|Bioequivalence|Ratio of geometric means (%)|101.4|||||TWO_SIDED|90.0|92.4|111.2||||||||111.2|92.4|
72384874|NCT01890746|144277542|OTHER|Bioequivalence|Ratio of geometric means (%)|120.0|||||TWO_SIDED|90.0|100.7|142.6||||||||142.6|100.7|
72384875|NCT01890746|144277543|OTHER|Bioequivalence|Ratio of geometric means (%)|105.2|||||TWO_SIDED|90.0|93.6|118.3||||||||118.3|93.6|
72384876|NCT01890746|144277544|OTHER|Bioequivalence|Ratio of geometric means (%)|80.4|||||TWO_SIDED|90.0|57.2|113.0||||||||113.0|57.2|
72437118|NCT00922207|144387588|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.69||||0.2362|TWO_SIDED|95.0|0.36|1.34|||Cochran-Mantel-Haenszel|||Week 52||1.34|0.36|0.2362
72437119|NCT00922207|144387588|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.97||||0.9861|TWO_SIDED|95.0|0.49|1.9|||Cochran-Mantel-Haenszel|||Week 64||1.90|0.49|0.9861
72558446|NCT00112437|144646477|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|2.66|||<=|0.001|TWO_SIDED|95.0|1.71|3.61||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through a stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on femoral neck BMD compared to placebo over 12 months. The secondary hypothesis states that odanacatib will increase femoral neck BMD compared to placebo over 12 months.||3.61|1.71|<=0.001
72558447|NCT00112437|144646477|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|1.89|||<=|0.001|TWO_SIDED|95.0|0.93|2.84||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on femoral neck BMD compared to placebo over 12 months. The secondary hypothesis states that odanacatib will increase femoral neck BMD compared to placebo over 12 months.||2.84|0.93|<=0.001
72558448|NCT00112437|144646477|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|0.87||||0.095|TWO_SIDED|95.0|-0.09|1.82||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on femoral neck BMD compared to placebo over 12 months. The secondary hypothesis states that odanacatib will increase femoral neck BMD compared to placebo over 12 months.||1.82|-0.09|0.095
72558449|NCT00112437|144646477|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-0.19|||||TWO_SIDED|95.0|-1.14|0.75|||ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on femoral neck BMD compared to placebo over 12 months. The secondary hypothesis states that odanacatib will increase femoral neck BMD compared to placebo over 12 months.||0.75|-1.14|
72558450|NCT00112437|144646478|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|2.94|||<=|0.001|TWO_SIDED|95.0|1.64|4.24||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on trochanter BMD compared to placebo over 12 months. The secondary hypothesis states that odanacatib will increase trochanter BMD compared to placebo over 12 months.||4.24|1.64|<=0.001
72558451|NCT00112437|144646478|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|2.65|||<=|0.001|TWO_SIDED|95.0|1.35|3.94||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance||The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on trochanter BMD compared to placebo over 12 months. The secondary hypothesis states that odanacatib will increase trochanter BMD compared to placebo over 12 months.||3.94|1.35|<=0.001
72558452|NCT00112437|144646478|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|2.38|||<=|0.001|TWO_SIDED|95.0|1.08|3.69||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on trochanter BMD compared to placebo over 12 months. The secondary hypothesis states that odanacatib will increase trochanter BMD compared to placebo over 12 months.||3.69|1.08|<=0.001
72558453|NCT00112437|144646478|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-0.29||||0.731|TWO_SIDED|95.0|-1.58|1.0||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through a stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on trochanter BMD compared to placebo over 12 months. The secondary hypothesis states that odanacatib will increase trochanter BMD compared to placebo over 12 months.||1.00|-1.58|0.731
72558454|NCT00112437|144646479|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|0.29||||0.112|TWO_SIDED|95.0|-0.77|1.35||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through a stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on total body BMD compared to placebo over 12 months. The secondary hypothesis states that odanacatib will increase total body BMD compared to placebo over 12 months.||1.35|-0.77|0.112
72494924|NCT00848354|144519136|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.18|||<|0.0001|TWO_SIDED|95.0|3.25|11.73||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 20.||11.73|3.25|<0.0001
72494925|NCT00848354|144519136|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.45|||<|0.0001|TWO_SIDED|95.0|3.67|11.33||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 24.||11.33|3.67|<0.0001
72494926|NCT00848354|144519138|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.09||||0.0349|TWO_SIDED|95.0|1.05|9.13||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 2.||9.13|1.05|0.0349
72494927|NCT00848354|144519138|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.87|||<|0.0001|TWO_SIDED|95.0|1.98|7.6||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 4.||7.60|1.98|<0.0001
72437120|NCT00922207|144387588|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.7||||0.2919|TWO_SIDED|95.0|0.37|1.35|||Cochran-Mantel-Haenszel|||Week 64||1.35|0.37|0.2919
72494928|NCT00848354|144519138|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.52|||<|0.0001|TWO_SIDED|95.0|2.1|5.88||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 8.||5.88|2.10|<0.0001
72494929|NCT00848354|144519138|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.2|||<|0.0001|TWO_SIDED|95.0|2.02|5.06||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 12.||5.06|2.02|<0.0001
72494930|NCT00848354|144519138|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.4|||<|0.0001|TWO_SIDED|95.0|2.78|6.96||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 16.||6.96|2.78|<0.0001
72494931|NCT00848354|144519138|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.4|||<|0.0001|TWO_SIDED|95.0|2.8|6.9||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 20.||6.90|2.80|<0.0001
72494932|NCT00848354|144519138|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.13|||<|0.0001|TWO_SIDED|95.0|3.82|9.85||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 24.||9.85|3.82|<0.0001
72494933|NCT00848354|144519140|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.25|||<|0.0001|TWO_SIDED|95.0|2.74|6.6||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 2.||6.60|2.74|<0.0001
72494934|NCT00848354|144519140|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.6|||<|0.0001|TWO_SIDED|95.0|2.94|7.18||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 4.||7.18|2.94|<0.0001
72437121|NCT00922207|144387588|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.72||||0.2674|TWO_SIDED|95.0|0.38|1.38|||Cochran-Mantel-Haenszel|||Week 64||1.38|0.38|0.2674
72437122|NCT00922207|144387588|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.84||||0.6148|TWO_SIDED|95.0|0.43|1.64|||Cochran-Mantel-Haenszel|||Week 76||1.64|0.43|0.6148
72437123|NCT00922207|144387588|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.57||||0.0904|TWO_SIDED|95.0|0.3|1.08|||Cochran-Mantel-Haenszel|||Week 76||1.08|0.30|0.0904
72437124|NCT00922207|144387588|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.68||||0.2073|TWO_SIDED|95.0|0.36|1.27|||Cochran-Mantel-Haenszel|||Week 76||1.27|0.36|0.2073
72437125|NCT00922207|144387588|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.02||||0.998|TWO_SIDED|95.0|0.52|1.98|||Cochran-Mantel-Haenszel|||Week 88||1.98|0.52|0.9980
72494935|NCT00848354|144519140|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.21|||<|0.0001|TWO_SIDED|95.0|3.15|8.61||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 8.||8.61|3.15|<0.0001
72494936|NCT00848354|144519140|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.77|||<|0.0001|TWO_SIDED|95.0|3.36|9.93||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 12.||9.93|3.36|<0.0001
72494937|NCT00848354|144519140|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|7.15|||<|0.0001|TWO_SIDED|95.0|3.91|13.09||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 16.||13.09|3.91|<0.0001
72494938|NCT00848354|144519140|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|8.43|||<|0.0001|TWO_SIDED|95.0|4.5|15.8||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 20.||15.80|4.50|<0.0001
72494939|NCT00848354|144519140|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.05|||<|0.0001|TWO_SIDED|95.0|3.5|10.47||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 24.||10.47|3.50|<0.0001
72494940|NCT00848354|144519142|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|7.4||||0.025|TWO_SIDED|95.0|0.96|56.88||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 2.||56.88|0.96|0.0250
72558455|NCT00112437|144646479|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-0.09|||||TWO_SIDED|95.0|-1.13|0.95||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through a stepdown trend-test approach. Multiplicity for multiple endpoints was handle by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on total body BMD compared to placebo over 12 months. The secondary hypothesis states that odanacatib will increase total body BMD compared to placebo over 12 months.||0.95|-1.13|
72384877|NCT01890746|144277545|OTHER|Bioequivalence|Ratio of geometric means (%)|106.3|||||TWO_SIDED|90.0|87.6|129.0||||||||129.0|87.6|
72384878|NCT01890746|144277546|OTHER|Bioequivalence|Ratio of geometric means (%)|127.1|||||TWO_SIDED|90.0|84.2|191.9||||||||191.9|84.2|
72384879|NCT01890746|144277547|OTHER|Bioequivalence|Ratio of geometric means (%)|110.5|||||TWO_SIDED|90.0|83.9|145.7||||||||145.7|83.9|
72384880|NCT01890746|144277548|OTHER|Bioequivalence|Ratio of geometric means (%)|286.4|||||TWO_SIDED|90.0|90.1|910.7||||||||910.7|90.1|
72384881|NCT01890746|144277549|OTHER|Bioequivalence|Ratio of geometric means (%)|202.3|||||TWO_SIDED|90.0|131.3|311.8||||||||311.8|131.3|
72437126|NCT00922207|144387588|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.74||||0.3489|TWO_SIDED|95.0|0.39|1.4|||Cochran-Mantel-Haenszel|||Week 88||1.40|0.39|0.3489
72437127|NCT00922207|144387588|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.73||||0.2847|TWO_SIDED|95.0|0.38|1.38|||Cochran-Mantel-Haenszel|||Week 88||1.38|0.38|0.2847
72437128|NCT00922207|144387588|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.84||||0.5596|TWO_SIDED|95.0|0.44|1.62|||Cochran-Mantel-Haenszel|||Week 100||1.62|0.44|0.5596
72437129|NCT00922207|144387588|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.67||||0.2112|TWO_SIDED|95.0|0.36|1.27|||Cochran-Mantel-Haenszel|||Week 100||1.27|0.36|0.2112
72437130|NCT00922207|144387588|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.8||||0.4066|TWO_SIDED|95.0|0.43|1.48|||Cochran-Mantel-Haenszel|||Week 100||1.48|0.43|0.4066
72437131|NCT00922207|144387590|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.41||||0.6921|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Baseline||||0.6921
72437132|NCT00922207|144387590|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.11||||0.3939|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Baseline||||0.3939
72437133|NCT00922207|144387590|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.5||||0.6818|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Baseline||||0.6818
72437134|NCT00922207|144387590|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.82||||0.7582|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 6||||0.7582
72437135|NCT00922207|144387590|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.67||||0.5381|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 6||||0.5381
72494941|NCT00848354|144519142|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.33||||0.0466|TWO_SIDED|95.0|1.0|5.45||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 4.||5.45|1.00|0.0466
72437136|NCT00922207|144387590|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.81||||0.7747|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 6||||0.7747
72384882|NCT01890746|144277551|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.7461|TWO_SIDED|95.0|0.28|2.48|||Log Rank|||||2.48|0.28|0.7461
72384883|NCT01890746|144277552|SUPERIORITY||Hazard Ratio (HR)|1.1||||0.6175|TWO_SIDED|95.0|0.74|1.63|||Log Rank|||||1.63|0.74|0.6175
72384884|NCT01890746|144277553|SUPERIORITY||Odds Ratio (OR)|0.5281||||0.3224|TWO_SIDED|95.0|0.1084|2.2086|||Cochran-Mantel-Haenszel|||||2.2086|0.1084|0.3224
72384885|NCT01890746|144277555|SUPERIORITY|||||||0.6942|||||||Wilcoxon rank-sum test|||||||0.6942
72384886|NCT01890746|144277556|SUPERIORITY||Odds Ratio (OR)|1.1151||||0.7397|TWO_SIDED|95.0|0.5585|2.229|||Cochran-Mantel-Haenszel|||||2.2290|0.5585|0.7397
72384887|NCT01890746|144277557|SUPERIORITY||Hazard Ratio (HR)|2.46||||0.0781|TWO_SIDED|95.0|0.95|6.38|||Log Rank|||||6.38|0.95|0.0781
72384888|NCT01890746|144277561|SUPERIORITY||Odds Ratio (OR)|0.8749||||0.7122|TWO_SIDED|95.0|0.4023|1.8943|||Cochran-Mantel-Haenszel|||||1.8943|0.4023|0.7122
72384889|NCT01890746|144277562|SUPERIORITY||Hazard Ratio (HR)|1.54||||0.0688|TWO_SIDED|95.0|0.96|2.47|||Log Rank|||||2.47|0.96|0.0688
72384890|NCT02642029|144277564|EQUIVALENCE|Tested the null hypothesis of no difference between iTBS and sham TBS on IDT accuracy.|Beta coefficient for timexiTBS interact|-0.099|STANDARD_ERROR_OF_MEAN|0.051||0.51|TWO_SIDED|95.0|-0.1989|0.0002||Significance threshold of p \< 0.05, two-sided.|Mixed Models Analysis|Model included time (pre, post), condition (iTBS vs. sham, cTBS vs. sham), and the interaction of time x condition (time x iTBS, time x cTBS).||Conducted a mixed effects analysis, with IDT accuracy as the dependent variable and time (pre, post), condition (iTBS vs. sham, cTBS vs. sham), and the interaction of time x condition (time x iTBS, time x cTBS) as the independent variables. P-value here is for the iTBS (vs. sham) x time interaction.||.0002|-.1989|0.51
72437137|NCT00922207|144387590|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.89||||0.8034|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 12||||0.8034
72437138|NCT00922207|144387590|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.23||||0.6306|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 12||||0.6306
72437139|NCT00922207|144387590|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.39||||0.4574|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 12||||0.4574
72437140|NCT00922207|144387590|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.81||||0.5824|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 16||||0.5824
72437141|NCT00922207|144387590|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.03||||0.9321|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 16||||0.9321
72437142|NCT00922207|144387590|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.26||||0.5263|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 16||||0.5263
72437143|NCT00922207|144387590|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.65||||0.2025|TWO_SIDED|95.0|||||Cochran-Mantel-Haenszel|||Week 22||||0.2025
72437144|NCT00922207|144387590|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.16||||0.6702|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 22||||0.6702
72437145|NCT00922207|144387590|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.77||||0.0818|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 22||||0.0818
72437146|NCT00922207|144387590|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.84||||0.6214|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 28||||0.6214
72437147|NCT00922207|144387590|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.16||||0.6774|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 28||||0.6774
72437148|NCT00922207|144387590|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.37||||0.3154|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 28||||0.3154
72437149|NCT00922207|144387590|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.69||||0.2709|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 34||||0.2709
72437150|NCT00922207|144387590|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.75||||0.3804|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 34||||0.3804
72437151|NCT00922207|144387590|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.08||||0.7645|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 34||||0.7645
72437152|NCT00922207|144387590|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.65||||0.182|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 40||||0.1820
72437153|NCT00922207|144387590|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.89||||0.7167|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 40||||0.7167
72437154|NCT00922207|144387590|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.37||||0.3104|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 40||||0.3104
72437155|NCT00922207|144387590|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.59||||0.091|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 46||||0.0910
72437156|NCT00922207|144387590|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.84||||0.6094|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 46||||0.6094
72437157|NCT00922207|144387590|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.42||||0.2166|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 46||||0.2166
72437158|NCT00922207|144387590|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.95||||0.901|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 52||||0.9010
72437159|NCT00922207|144387590|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.03||||0.906|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 52||||0.9060
72437160|NCT00922207|144387590|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.08||||0.7268|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 52||||0.7268
72437161|NCT00922207|144387590|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.81||||0.5372|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 64||||0.5372
72437162|NCT00922207|144387590|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.65||||0.1588|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 64||||0.1588
72437163|NCT00922207|144387590|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.8||||0.4268|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 64||||0.4268
72437164|NCT00922207|144387590|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.26||||0.4389|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 76||||0.4389
72437165|NCT00922207|144387590|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.89||||0.6708|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 76||||0.6708
72437166|NCT00922207|144387590|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.7||||0.2145|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 76||||0.2145
72437167|NCT00922207|144387590|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.98||||0.8608|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 88||||0.8608
72437168|NCT00922207|144387590|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.52||||0.0283|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 88||||0.0283
72437169|NCT00922207|144387590|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.53||||0.0369|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 88||||0.0369
72437170|NCT00922207|144387590|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.84||||0.4606|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 100||||0.4606
72437171|NCT00922207|144387590|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.6||||0.0832|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 100||||0.0832
72437172|NCT00922207|144387590|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.71||||0.2655|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 100||||0.2655
72437173|NCT00922207|144387591|SUPERIORITY_OR_OTHER||LS Mean Difference|0.21||||0.0649|TWO_SIDED|95.0|-0.01|0.43|||ANCOVA|||Baseline||0.43|-0.01|0.0649
72437174|NCT00922207|144387591|SUPERIORITY_OR_OTHER||LS Mean Difference|0.13||||0.1867|TWO_SIDED|95.0|-0.06|0.33|||ANCOVA|||Baseline||0.33|-0.06|0.1867
72437175|NCT00922207|144387591|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.08||||0.5003|TWO_SIDED|95.0|-0.3|0.15|||ANCOVA|||Baseline||0.15|-0.30|0.5003
72437176|NCT00922207|144387591|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.08||||0.2259|TWO_SIDED|95.0|-0.22|0.05|||ANCOVA|||Change at Week 4||0.05|-0.22|0.2259
72437177|NCT00922207|144387591|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.24|||<|0.001|TWO_SIDED|95.0|-0.36|-0.11|||ANCOVA|||Change at Week 4||-0.11|-0.36|<0.001
72437178|NCT00922207|144387591|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.15||||0.0085|TWO_SIDED|95.0|-0.27|-0.04|||ANCOVA|||Change at Week 4||-0.04|-0.27|0.0085
72437179|NCT00922207|144387591|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.02||||0.816|TWO_SIDED|95.0|-0.22|0.18|||ANCOVA|||Change at Week 8||0.18|-0.22|0.8160
72437180|NCT00922207|144387591|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.08||||0.4393|TWO_SIDED|95.0|-0.27|0.12|||ANCOVA|||Change at Week 8||0.12|-0.27|0.4393
72437181|NCT00922207|144387591|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.06||||0.489|TWO_SIDED|95.0|-0.22|0.11|||ANCOVA|||Change at Week 8||0.11|-0.22|0.4890
72437182|NCT00922207|144387591|SUPERIORITY_OR_OTHER||LS Mean Difference|0.08||||0.4656|TWO_SIDED|95.0|-0.14|0.3|||ANCOVA|||Change at Week 16||0.30|-0.14|0.4656
72437183|NCT00922207|144387591|SUPERIORITY_OR_OTHER||LS Mean Difference|0.08||||0.5016|TWO_SIDED|95.0|-0.15|0.31|||ANCOVA|||Change at Week 16||0.31|-0.15|0.5016
72437184|NCT00922207|144387591|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.01||||0.9582|TWO_SIDED|95.0|-0.23|0.22|||ANCOVA|||Change at Week 16||0.22|-0.23|0.9582
72437185|NCT00922207|144387591|SUPERIORITY_OR_OTHER||LS Mean Difference|0.07||||0.6214|TWO_SIDED|95.0|-0.21|0.36|||ANCOVA|||Change at Week 28||0.36|-0.21|0.6214
72437186|NCT00922207|144387591|SUPERIORITY_OR_OTHER||LS Mean Difference|0.09||||0.5493|TWO_SIDED|95.0|-0.21|0.39|||ANCOVA|||Change at Week 28||0.39|-0.21|0.5493
72437187|NCT00922207|144387591|SUPERIORITY_OR_OTHER||LS Mean Difference|0.02||||0.8881|TWO_SIDED|95.0|-0.28|0.32|||ANCOVA|||Change at Week 28||0.32|-0.28|0.8881
72437188|NCT00922207|144387591|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.04||||0.7912|TWO_SIDED|95.0|-0.36|0.27|||ANCOVA|||Change at Week 40||0.27|-0.36|0.7912
72437189|NCT00922207|144387591|SUPERIORITY_OR_OTHER||LS Mean Difference|0.11||||0.5427|TWO_SIDED|95.0|-0.24|0.46|||ANCOVA|||Change at Week 40||0.46|-0.24|0.5427
72437190|NCT00922207|144387591|SUPERIORITY_OR_OTHER||LS Mean Difference|0.15||||0.3788|TWO_SIDED|95.0|-0.19|0.49|||ANCOVA|||Change at Week 40||0.49|-0.19|0.3788
72437191|NCT00922207|144387591|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.09||||0.6172|TWO_SIDED|95.0|-0.44|0.26|||ANCOVA|||Change at Week 52||0.26|-0.44|0.6172
72437192|NCT00922207|144387591|SUPERIORITY_OR_OTHER||LS Mean Difference|0.11||||0.6002|TWO_SIDED|95.0|-0.29|0.5|||ANCOVA|||Change at Week 52||0.50|-0.29|0.6002
72437193|NCT00922207|144387591|SUPERIORITY_OR_OTHER||LS Mean Difference|0.19||||0.3101|TWO_SIDED|95.0|-0.18|0.56|||ANCOVA|||Change at Week 52||0.56|-0.18|0.3101
72437194|NCT00922207|144387591|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.14||||0.4256|TWO_SIDED|95.0|-0.47|0.2|||ANCOVA|||Change at Week 64||0.20|-0.47|0.4256
72437195|NCT00922207|144387591|SUPERIORITY_OR_OTHER||LS Mean Difference|0.01||||0.9762|TWO_SIDED|95.0|-0.35|0.36|||ANCOVA|||Change at Week 64||0.36|-0.35|0.9762
72437196|NCT00922207|144387591|SUPERIORITY_OR_OTHER||LS Mean Difference|0.13||||0.4504|TWO_SIDED|95.0|-0.21|0.47|||ANCOVA|||Change at Week 64||0.47|-0.21|0.4504
72437197|NCT00922207|144387591|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.12||||0.4076|TWO_SIDED|95.0|-0.42|0.17|||ANCOVA|||Change at Week 76||0.17|-0.42|0.4076
72437198|NCT00922207|144387591|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.05||||0.7591|TWO_SIDED|95.0|-0.37|0.27|||ANCOVA|||Change at Week 76||0.27|-0.37|0.7591
72494942|NCT00848354|144519142|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.84||||0.0007|TWO_SIDED|95.0|1.5|5.36||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 8.||5.36|1.50|0.0007
72494943|NCT00848354|144519142|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.97|||<|0.0001|TWO_SIDED|95.0|1.7|5.18||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 12.||5.18|1.70|<0.0001
72494944|NCT00848354|144519142|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.06|||<|0.0001|TWO_SIDED|95.0|1.85|5.05||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 16.||5.05|1.85|<0.0001
72494945|NCT00848354|144519142|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.12|||<|0.0001|TWO_SIDED|95.0|2.47|6.87||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 20.||6.87|2.47|<0.0001
72494946|NCT00848354|144519142|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.51|||<|0.0001|TWO_SIDED|95.0|3.72|11.38||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 24.||11.38|3.72|<0.0001
72494947|NCT00848354|144519144|SUPERIORITY_OR_OTHER|||||||0.3054||||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 2.||||0.3054
72494948|NCT00848354|144519144|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.09||||0.4044|TWO_SIDED|95.0|0.58|7.53||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 4.||7.53|0.58|0.4044
72494949|NCT00848354|144519144|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.53||||0.0388|TWO_SIDED|95.0|1.02|6.26||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 8.||6.26|1.02|0.0388
72494950|NCT00848354|144519144|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.89||||0.0059|TWO_SIDED|95.0|1.31|6.34||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 12.||6.34|1.31|0.0059
72494951|NCT00848354|144519144|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.3|||<|0.0001|TWO_SIDED|95.0|1.99|9.29||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 16.||9.29|1.99|<0.0001
72494952|NCT00848354|144519144|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.94|||<|0.0001|TWO_SIDED|95.0|2.88|12.24||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 20.||12.24|2.88|<0.0001
72494953|NCT00848354|144519144|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|9.18|||<|0.0001|TWO_SIDED|95.0|3.61|23.32||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 24.||23.32|3.61|<0.0001
72494954|NCT00848354|144519146|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|7.4||||0.025|TWO_SIDED|95.0|0.96|56.88||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 2.||56.88|0.96|0.0250
72494955|NCT00848354|144519146|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.33||||0.0466|TWO_SIDED|95.0|1.0|5.45||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 4.||5.45|1.00|0.0466
72494956|NCT00848354|144519146|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.84||||0.0007|TWO_SIDED|95.0|1.5|5.36||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 8.||5.36|1.50|0.0007
72494957|NCT00848354|144519146|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.97|||<|0.0001|TWO_SIDED|95.0|1.7|5.18||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 12.||5.18|1.70|<0.0001
72437199|NCT00922207|144387591|SUPERIORITY_OR_OTHER||LS Mean Difference|0.08||||0.6449|TWO_SIDED|95.0|-0.25|0.4|||ANCOVA|||Change at Week 76||0.40|-0.25|0.6449
72437200|NCT00922207|144387591|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.06||||0.7108|TWO_SIDED|95.0|-0.36|0.25|||ANCOVA|||Change at Week 88||0.25|-0.36|0.7108
72437201|NCT00922207|144387591|SUPERIORITY_OR_OTHER||LS Mean Difference|0.12||||0.4725|TWO_SIDED|95.0|-0.22|0.47|||ANCOVA|||Change at Week 88||0.47|-0.22|0.4725
72437202|NCT00922207|144387591|SUPERIORITY_OR_OTHER||LS Mean Difference|0.19||||0.2439|TWO_SIDED|95.0|-0.13|0.5|||ANCOVA|||Change at Week 88||0.50|-0.13|0.2439
72618774|NCT01026038|144768112|SUPERIORITY_OR_OTHER||Percent Difference|1.8|||||TWO_SIDED|95.0|-4.8|9.5||||||Serotype 19F: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 7vPnC/7vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/13vPnC/13vPnC along with exact 2-sided 95% CI.||9.5|-4.8|
72384891|NCT02642029|144277564|EQUIVALENCE|Tested the null hypothesis of no difference between iTBS and sham TBS on IDT accuracy.|Beta coefficient for timexcTBS interact|-0.0757|STANDARD_ERROR_OF_MEAN|0.052||0.143|TWO_SIDED|95.0|-0.177|0.0256||Significance threshold of p \< 0.05, two-sided.|Mixed Models Analysis|Model included time (pre, post), condition (iTBS vs. sham, cTBS vs. sham), and the interaction of time x condition (time x iTBS, time x cTBS).||Conducted a mixed effects analysis, with IDT accuracy as the dependent variable and time (pre, post), condition (iTBS vs. sham, cTBS vs. sham), and the interaction of time x condition (time x iTBS, time x cTBS) as the independent variables. P-value here is for the cTBS (vs. sham) x time interaction.||.0256|-.1770|0.143
72384892|NCT02642029|144277565|EQUIVALENCE|Tested the null hypothesis of no difference between iTBS and sham TBS on N-back accuracy.|Beta coefficient for timexiTBS interact|-0.0446||||0.626|TWO_SIDED|||||Significance threshold was p \< 0.05, two-sided.|Mixed Models Analysis|||"Conducted a generalized linear mixed model fit by maximum likelihood (Laplace Approximation) \['glmerMod' in R\] with binomial (logit) distribution.~N-back accuracy was the dependent variable. Time (pre vs. post), condition (iTBS vs. sham, cTBS vs. sham), and the interaction of time x condition (time x iTBS, time x cTBS) were the independent variables. P-value here is for the iTBS (vs. sham) x time interaction."||||.626
72384893|NCT02642029|144277565|EQUIVALENCE|Tested the null hypothesis of no difference between cTBS and sham TBS on N-back accuracy.|Beta coefficient for timexcTBS interact|-0.0903||||0.322|TWO_SIDED|||||Significance threshold was p \< 0.05, two-sided.|Mixed Models Analysis|||"Conducted a generalized linear mixed model fit by maximum likelihood (Laplace Approximation) \['glmerMod' in R\] with binomial (logit) distribution.~N-back accuracy was the dependent variable. Time (pre vs. post), condition (iTBS vs. sham, cTBS vs. sham), and the interaction of time x condition (time x iTBS, time x cTBS) were the independent variables. P-value here is for the cTBS (vs. sham) x time interaction."||||0.322
72384894|NCT02642029|144277566|EQUIVALENCE|Tested the null hypothesis of no difference between iTBS and sham TBS on N-back accuracy.|Beta coefficient for timexiTBS interact|-9.797||||0.1118|TWO_SIDED|||||Significance threshold of p \< 0.05, two-sided|Mixed Models Analysis|||"Conducted a generalized linear mixed model fit by maximum likelihood (Laplace Approximation) \['glmerMod' in R\] with gamma distribution.~N-back reaction time (RT) was the dependent variable. Time (pre vs. post), condition (iTBS vs. sham, cTBS vs. sham), and the interaction of time x condition (time x iTBS, time x cTBS) were the independent variables. P-value here is for the iTBS (vs. sham) x time interaction."||||0.1118
72384895|NCT02642029|144277566|EQUIVALENCE|Tested the null hypothesis of no difference between cTBS and sham TBS on N-back accuracy.|Beta coefficient for timexcTBS interact|-47.764||||9e-08|TWO_SIDED|||||Significance threshold was p \< 0.05, two-sided.|Mixed Models Analysis|||"Conducted a generalized linear mixed model fit by maximum likelihood (Laplace Approximation) \['glmerMod' in R\] with gamma distribution.~N-back reaction time (RT) was the dependent variable. Time (pre vs. post), condition (iTBS vs. sham, cTBS vs. sham), and the interaction of time x condition (time x iTBS, time x cTBS) were the independent variables. P-value here is for the cTBS (vs. sham) x time interaction."||||0.00000009
72384896|NCT02642029|144277567|EQUIVALENCE|Tested the null hypothesis that there is no effect of condition (iTBS, cTBS, sham) on pre-post change in VAS scores.||||||0.91||||||Given the exploratory nature of this pilot study, we set the significance threshold at p \< 0.05, two-sided, without correcting for eight comparisons.|Friedman test|Non-parametric repeated measures ANOVA.||||||0.910
72384897|NCT02642029|144277567|OTHER|Given the exploratory nature of this pilot study, we set the significance threshold at p \<0.05, two-sided, without correcting for eight comparisons.|beta coefficient for depressed mood|0.00071||||0.243|TWO_SIDED|95.0|-0.00048|0.0019|||Mixed Models Analysis|||We explored the association between interval discrimination task (IDT) performance (accuracy) and each symptom self-rating (here, depressed mood). We conducted a mixed effects regression analysis to test the null hypothesis of no association. Model included time (pre, post) and condition (iTBS vs. sham, cTBS vs. sham) in addition to symptom rating as independent variables, and IDT performance accuracy as the dependent variable.||0.00190|-0.00048|0.243
72384898|NCT02642029|144277568|EQUIVALENCE|Tested the null hypothesis that there is no effect of condition (iTBS, cTBS, sham) on pre-post change in VAS scores.||||||0.83||||||Given the exploratory nature of this pilot study, we set the significance threshold at p \< 0.05, two-sided, without correcting for eight comparisons.|Friedman test|Non-parametric repeated measures ANOVA.||||||0.830
72384899|NCT02642029|144277568|OTHER||beta coefficient for anxiety|-0.00063||||0.284|TWO_SIDED|95.0|-0.00179|0.00052||Given the exploratory nature of this pilot study, we set the significance threshold at p \<0.05, two-sided, without correcting for eight comparisons.|Mixed Models Analysis|||We explored the association between interval discrimination task (IDT) performance (accuracy) and each symptom self-rating (here, anxiety). We conducted a mixed effects regression analysis to test the null hypothesis of no association. Model included time (pre, post) and condition (iTBS vs. sham, cTBS vs. sham) in addition to symptom rating as independent variables, and IDT performance accuracy as the dependent variable.||0.00052|-0.00179|0.284
72384900|NCT02642029|144277569|EQUIVALENCE|Tested the null hypothesis that there is no effect of condition (iTBS, cTBS, sham) on pre-post change in VAS scores.||||||0.755||||||Given the exploratory nature of this pilot study, we set the significance threshold at p \< 0.05, two-sided, without correcting for eight comparisons.|Friedman test|Non-parametric repeated measures ANOVA.||||||0.755
72437203|NCT00922207|144387591|SUPERIORITY_OR_OTHER||LS Mean Difference|0.2||||0.1862|TWO_SIDED|95.0|-0.1|0.5|||ANCOVA|||Change at Week 100||0.50|-0.10|0.1862
72437204|NCT00922207|144387591|SUPERIORITY_OR_OTHER||LS Mean Difference|0.15||||0.3057|TWO_SIDED|95.0|-0.14|0.43|||ANCOVA|||Change at Week 100||0.43|-0.14|0.3057
72437205|NCT00922207|144387591|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.04||||0.8002|TWO_SIDED|95.0|-0.38|0.29|||ANCOVA|||Change at Week 100||0.29|-0.38|0.8002
72437206|NCT04707313|144387615|SUPERIORITY||Difference to placebo|-5.6|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|90.0|-7.41|-3.74|||Mixed Models Analysis||MMRM:treatment,time,strata(female vs male),treatment-by-time interaction as fixed effect, natural log-transformed baseline as covariate,natural log-transformed baseline-by-time interaction with time fitted:repeated effect, participant:random effect.|||-3.74|-7.41|<.0001
72437207|NCT04707313|144387615|SUPERIORITY||Difference to placebo|-5.0|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|90.0|-6.8|-3.16|||Mixed Models Analysis||MMRM:treatment,time,strata(female vs male),treatment-by-time interaction as fixed effect, natural log-transformed baseline as covariate,natural log-transformed baseline-by-time interaction with time fitted:repeated effect, participant:random effect.|||-3.16|-6.80|<.0001
72437208|NCT04707313|144387615|SUPERIORITY||Difference to Placebo|-9.1|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|90.0|-10.89|-7.28|||Mixed Models Analysis||MMRM:treatment,time,strata(female vs male),treatment-by-time interaction as fixed effect, natural log-transformed baseline as covariate,natural log-transformed baseline-by-time interaction with time fitted:repeated effect, participant:random effect.|||-7.28|-10.89|<.0001
72437209|NCT04707313|144387615|SUPERIORITY||Difference to Placebo|-6.6|STANDARD_ERROR_OF_MEAN|0.014|<|0.0001|TWO_SIDED|90.0|-8.75|-4.39|||Mixed Models Analysis||MMRM:treatment,time,strata(female vs male),treatment-by-time interaction as fixed effect, natural log-transformed baseline as covariate,natural log-transformed baseline-by-time interaction with time fitted:repeated effect, participant:random effect.|||-4.39|-8.75|<.0001
72437210|NCT04707313|144387615|SUPERIORITY||Difference to Placebo|-9.52|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|90.0|-11.43|-7.56|||Mixed Models Analysis||MMRM:treatment,time,strata(female vs male),treatment-by-time interaction as fixed effect, natural log-transformed baseline as covariate,natural log-transformed baseline-by-time interaction with time fitted:repeated effect, participant:random effect.|||-7.56|-11.43|<.0001
72494958|NCT00848354|144519146|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.06|||<|0.0001|TWO_SIDED|95.0|1.85|5.05||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 16.||5.05|1.85|<0.0001
72494959|NCT00848354|144519146|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.12|||<|0.0001|TWO_SIDED|95.0|2.47|6.87||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 20.||6.87|2.47|<0.0001
72494960|NCT00848354|144519146|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.51|||<|0.0001|TWO_SIDED|95.0|3.72|11.38||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 24.||11.38|3.72|<0.0001
72494961|NCT00848354|144519148|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.53|||<|0.0001|TWO_SIDED|95.0|2.9|7.07||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 2.||7.07|2.90|<0.0001
72437211|NCT04707313|144387615|SUPERIORITY||Difference to Placebo|-7.12|STANDARD_ERROR_OF_MEAN|0.015|<|0.0001|TWO_SIDED|90.0|-9.41|-4.78|||Mixed Models Analysis||MMRM:treatment,time,strata(female vs male),treatment-by-time interaction as fixed effect, natural log-transformed baseline as covariate,natural log-transformed baseline-by-time interaction with time fitted:repeated effect, participant:random effect.|||-4.78|-9.41|<.0001
72494962|NCT00848354|144519148|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.01|||<|0.0001|TWO_SIDED|95.0|2.36|6.8||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 4.||6.80|2.36|<0.0001
72558456|NCT00112437|144646479|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-0.63|||||TWO_SIDED|95.0|-1.69|0.42||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through a stepdown trend-test approach. Multiplicity for multiple endpoints was handle by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on total body BMD compared to placebo over 12 months. The secondary hypothesis states that odanacatib will increase total body BMD compared to placebo over 12 months.||0.42|-1.69|
72437212|NCT04707313|144387615|SUPERIORITY||Difference to Placebo|-9.12|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|90.0|-11.11|-7.08|||Mixed Models Analysis||MMRM:treatment,time,strata(female vs male),treatment-by-time interaction as fixed effect, natural log-transformed baseline as covariate,natural log-transformed baseline-by-time interaction with time fitted:repeated effect, participant:random effect.|||-7.08|-11.11|<.0001
72437213|NCT04707313|144387615|SUPERIORITY||Difference to Placebo|-7.18|STANDARD_ERROR_OF_MEAN|0.014|<|0.0001|TWO_SIDED|90.0|-9.32|-4.99|||Mixed Models Analysis||MMRM:treatment,time,strata(female vs male),treatment-by-time interaction as fixed effect, natural log-transformed baseline as covariate,natural log-transformed baseline-by-time interaction with time fitted:repeated effect, participant:random effect.|||-4.99|-9.32|<.0001
72494963|NCT00848354|144519148|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.23|||<|0.0001|TWO_SIDED|95.0|2.82|9.72||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 8.||9.72|2.82|<0.0001
72494964|NCT00848354|144519148|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.25|||<|0.0001|TWO_SIDED|95.0|2.63|10.47||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 12.||10.47|2.63|<0.0001
72494965|NCT00848354|144519148|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.53|||<|0.0001|TWO_SIDED|95.0|3.16|13.48||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 16.||13.48|3.16|<0.0001
72494966|NCT00848354|144519148|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|8.38|||<|0.0001|TWO_SIDED|95.0|3.86|18.17||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 20.||18.17|3.86|<0.0001
72494967|NCT00848354|144519148|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|7.84|||<|0.0001|TWO_SIDED|95.0|3.94|15.62||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 24.||15.62|3.94|<0.0001
72558457|NCT00112437|144646479|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-1.47|||||TWO_SIDED|95.0|-2.53|-0.42||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through a stepdown trend-test approach. Multiplicity for multiple endpoints was handle by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on total body BMD compared to placebo over 12 months. The secondary hypothesis states that odanacatib will increase total body BMD compared to placebo over 12 months.||-0.42|-2.53|
72558458|NCT00112437|144646480|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|1.23|||<=|0.001|TWO_SIDED|95.0|0.22|2.24||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through a stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on distal forearm BMD compared to placebo over 12 months. The secondary hypothesis states that odanacatib will increase distal forearm BMD compared to placebo over 12 months.||2.24|0.22|<=0.001
72558459|NCT00112437|144646480|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|1.1||||0.005|TWO_SIDED|95.0|0.09|2.11||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through a stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on distal forearm BMD compared to placebo over 12 months. The secondary hypothesis states that odanacatib will increase distal forearm BMD compared to placebo over 12 months.||2.11|0.09|0.005
72558460|NCT00112437|144646480|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|0.27||||0.63|TWO_SIDED|95.0|-0.74|1.29||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through a stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on distal forearm BMD compared to placebo over 12 months. The secondary hypothesis states that odanacatib will increase distal forearm BMD compared to placebo over 12 months.||1.29|-0.74|0.630
72558461|NCT00112437|144646480|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-1.27|||||TWO_SIDED|95.0|-2.28|-0.27||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through a stepdown trend-test approach. Multiplicity for multiple endpoints was handle by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on distal forearm BMD compared to placebo over 12 months. The secondary hypothesis states that odanacatib will increase distal forearm BMD compared to placebo over 12 months.||-0.27|-2.28|
72558462|NCT00112437|144646481|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-57.86|||<=|0.001|TWO_SIDED|95.0|-72.33|-43.38||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through a stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure|ANCOVA|Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance|Difference in Least Squares Means (back-transformation of difference in log-fractions from baseline)|The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone resorption (u-NTx) compared to placebo over 12 months. The secondary hypothesis states that odanacatib will decrease biochemical indices of bone resorption (u-NTx) over 12 months.||-43.38|-72.33|<=0.001
72384901|NCT02642029|144277569|OTHER||beta coefficient for elated mood|-0.0007||||0.317|TWO_SIDED|95.0|-0.00208|0.00067||Given the exploratory nature of this pilot study, we set the significance threshold at p \<0.05, two-sided, without correcting for eight comparisons.|Mixed Models Analysis|||We explored the association between interval discrimination task (IDT) performance (accuracy) and each symptom self-rating (here, elated mood). We conducted a mixed effects regression analysis to test the null hypothesis of no association. Model included time (pre, post) and condition (iTBS vs. sham, cTBS vs. sham) in addition to symptom rating as independent variables, and IDT performance accuracy as the dependent variable.||0.00067|-0.00208|0.317
72384902|NCT02642029|144277570|EQUIVALENCE|Tested the null hypothesis that there is no effect of condition (iTBS, cTBS, sham) on pre-post change in VAS scores.||||||0.035||||||Given the exploratory nature of this pilot study, we set the significance threshold at p \< 0.05, two-sided, without correcting for eight comparisons.|Friedman test|Non-parametric repeated measures ANOVA.||||||.035
72384903|NCT02642029|144277570|OTHER||beta coefficient for auditory hallucinat|0.00195||||0.028|TWO_SIDED|95.0|0.00021|0.00369||Given the exploratory nature of this pilot study, we set the significance threshold at p \<0.05, two-sided, without correcting for eight comparisons.|Mixed Models Analysis|||We explored the association between interval discrimination task (IDT) performance (accuracy) and each symptom self-rating (here, auditory hallucinations). We conducted a mixed effects regression analysis to test the null hypothesis of no association. Model included time (pre, post) and condition (iTBS vs. sham, cTBS vs. sham) in addition to symptom rating as independent variables, and IDT performance accuracy as the dependent variable.||0.00369|0.00021|0.028
72437214|NCT04707313|144387616|SUPERIORITY||Difference to Placebo|-8.21|STANDARD_ERROR_OF_MEAN|0.023|<|0.0001|TWO_SIDED|90.0|-11.66|-4.63|||Mixed Models Analysis||MMRM:treatment,time,strata(female vs male),treatment-by-time interaction as fixed effect, natural log-transformed baseline as covariate,natural log-transformed baseline-by-time interaction with time fitted:repeated effect, participant:random effect.|||-4.63|-11.66|<.0001
72558463|NCT00112437|144646481|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-45.92|||<=|0.001|TWO_SIDED|95.0|-60.93|-30.91||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through a stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure|ANCOVA|Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance|Difference in Least Squares Means (back-transformation of difference in log-fractions from baseline)|The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone resorption (u-NTx) compared to placebo over 12 months. The secondary hypothesis states that odanacatib will decrease biochemical indices of bone resorption (u-NTx) over 12 months.||-30.91|-60.93|<=0.001
72558464|NCT00112437|144646481|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-31.84|||<=|0.001|TWO_SIDED|95.0|-48.11|-15.58||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through a stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure|ANCOVA|Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance|Difference in Least Squares Means (back-transformation of difference in log-fractions from baseline)|The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone resorption (u-NTx) compared to placebo over 12 months. The secondary hypothesis states that odanacatib will decrease biochemical indices of bone resorption (u-NTx) over 12 months.||-15.58|-48.11|<=0.001
72558465|NCT00112437|144646481|SUPERIORITY_OR_OTHER||Difference in Least Square Means|11.17||||0.249|TWO_SIDED|95.0|-0.94|43.24||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance|Difference in Least Squares Means (back-transformation of difference in log-fractions from baseline)|The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone resorption (u-NTx) compared to placebo over 12 months. The secondary hypothesis states that odanacatib will decrease biochemical indices of bone resorption (u-NTx) over 12 months.||43.24|-0.94|0.249
72618775|NCT01026038|144768112|SUPERIORITY_OR_OTHER||Percent Difference|0.0|||||TWO_SIDED|95.0|-3.5|6.7||||||Serotype 23F: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 13vPnC/13vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/7vPnC/13vPnC along with exact 2-sided 95% CI.||6.7|-3.5|
72618776|NCT01026038|144768112|SUPERIORITY_OR_OTHER||Percent Difference|0.0|||||TWO_SIDED|95.0|-3.6|6.4||||||Serotype 23F: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 13vPnC/13vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/13vPnC/13vPnC along with exact 2-sided 95% CI.||6.4|-3.6|
72494968|NCT00848354|144519150|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.67|||<|0.0001|TWO_SIDED|95.0|2.35|5.73||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 2.||5.73|2.35|<0.0001
72494969|NCT00848354|144519150|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.65|||<|0.0001|TWO_SIDED|95.0|3.0|7.22||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 4.||7.22|3.00|<0.0001
72494970|NCT00848354|144519150|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.96|||<|0.0001|TWO_SIDED|95.0|3.05|8.06||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 8.||8.06|3.05|<0.0001
72384904|NCT02642029|144277571|EQUIVALENCE|Tested the null hypothesis that there is no effect of condition (iTBS, cTBS, sham) on pre-post change in VAS scores.||||||0.748||||||Given the exploratory nature of this pilot study, we set the significance threshold at p \< 0.05, two-sided, without correcting for eight comparisons.|Friedman test|Non-parametric repeated measures ANOVA.||||||.748
72384905|NCT02642029|144277571|OTHER||beta coefficient for visual hallucinatio|-0.00039||||0.685|TWO_SIDED|95.0|-0.0023|0.00151||Given the exploratory nature of this pilot study, we set the significance threshold at p \<0.05, two-sided, without correcting for eight comparisons.|Mixed Models Analysis|||We explored the association between interval discrimination task (IDT) performance (accuracy) and each symptom self-rating (here, visual hallucinations). We conducted a mixed effects regression analysis to test the null hypothesis of no association. Model included time (pre, post) and condition (iTBS vs. sham, cTBS vs. sham) in addition to symptom rating as independent variables, and IDT performance accuracy as the dependent variable.||0.00151|-0.00230|0.685
72384906|NCT02642029|144277572|EQUIVALENCE|Tested the null hypothesis that there is no effect of condition (iTBS, cTBS, sham) on pre-post change in VAS scores.||||||0.02||||||Given the exploratory nature of this pilot study, we set the significance threshold at p \< 0.05, two-sided, without correcting for eight comparisons.|Friedman test|Non-parametric repeated measures ANOVA.||||||.020
72384907|NCT02642029|144277572|OTHER||beta coefficient for paranoid ideation|0.0004||||0.597|TWO_SIDED|95.0|-0.00108|0.00188||Given the exploratory nature of this pilot study, we set the significance threshold at p \<0.05, two-sided, without correcting for eight comparisons.|Mixed Models Analysis|||We explored the association between interval discrimination task (IDT) performance (accuracy) and each symptom self-rating (here, paranoid ideation). We conducted a mixed effects regression analysis to test the null hypothesis of no association. Model included time (pre, post) and condition (iTBS vs. sham, cTBS vs. sham) in addition to symptom rating as independent variables, and IDT performance accuracy as the dependent variable.||0.00188|-0.00108|0.597
72384908|NCT02642029|144277573|EQUIVALENCE|Tested the null hypothesis that there is no effect of condition (iTBS, cTBS, sham) on pre-post change in VAS scores.||||||0.237||||||Given the exploratory nature of this pilot study, we set the significance threshold at p \< 0.05, two-sided, without correcting for eight comparisons.|Friedman test|Non-parametric repeated measures ANOVA.||||||.237
72558466|NCT00112437|144646482|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-56.33|||<=|0.001||95.0|-75.86|-36.81||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance|Difference in Least Squares Means (back-transformation from difference in log-fraction)|The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone resorption (s-CTx) compared to placebo over 12 months. The secondary hypothesis states that odanacatib will decrease biochemical indices of bone resorption (s-CTx) over 12 months.||-36.81|-75.86|<=0.001
72558467|NCT00112437|144646482|SUPERIORITY_OR_OTHER||Difference in Least Square Means|-35.57|||<=|0.001||95.0|-56.63|-14.51||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through a stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure|ANCOVA|Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance|Difference in Least Square Means (back-transformation from difference in log-fraction)|The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone resorption (s-CTx) compared to placebo over 12 months. The secondary hypothesis states that odanacatib will decrease biochemical indices of bone resorption (s-CTx) over 12 months.||-14.51|-56.63|<=0.001
72558468|NCT00112437|144646482|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-21.66||||0.08||95.0|-44.54|1.23||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance|Difference in Least Squares Means (back-transformation from difference in log-fraction)|The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone resorption (s-CTx) compared to placebo over 12 months. The secondary hypothesis states that odanacatib will decrease biochemical indices of bone resorption (s-CTx) over 12 months.||1.23|-44.54|0.080
72558469|NCT00112437|144646482|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|19.7|||||TWO_SIDED|95.0|-8.48|47.88||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through a stepdown trend-test approach. Multiplicity for multiple endpoints was handle by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance|Difference in Least Squares Means (back-transformation from difference in log-fraction)|The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone resorption (s-CTx) compared to placebo over 12 months. The secondary hypothesis states that odanacatib will decrease biochemical indices of bone resorption (s-CTx) over 12 months.||47.88|-8.48|
72558470|NCT00112437|144646483|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-18.28||||0.004|TWO_SIDED|95.0|-35.82|-0.74||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance|Difference in Least Squares Means (back-transformation of difference in log-fractions from baseline)|The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone resorption (u-DPyr) compared to placebo over 12 months. The secondary hypothesis states that odanacatib will decrease biochemical indices of bone resorption (u-DPyr) over 12 months.||-0.74|-35.82|0.004
72437215|NCT04707313|144387616|SUPERIORITY||Difference to placebo|-8.44|STANDARD_ERROR_OF_MEAN|0.023|<|0.0001|TWO_SIDED|90.0|-11.83|-4.92|||Mixed Models Analysis||MMRM:treatment,time,strata(female vs male),treatment-by-time interaction as fixed effect, natural log-transformed baseline as covariate,natural log-transformed baseline-by-time interaction with time fitted:repeated effect, participant:random effect.|||-4.92|-11.83|<.0001
72384909|NCT02642029|144277573|OTHER||beta coefficient for ideas/del of refere|-0.00142||||0.178|TWO_SIDED|95.0|-0.0035|0.00065||Given the exploratory nature of this pilot study, we set the significance threshold at p \<0.05, two-sided, without correcting for eight comparisons.|Mixed Models Analysis|||We explored the association between interval discrimination task (IDT) performance (accuracy) and each symptom self-rating (here, ideas/delusions of reference). We conducted a mixed effects regression analysis to test the null hypothesis of no association. Model included time (pre, post) and condition (iTBS vs. sham, cTBS vs. sham) in addition to symptom rating as independent variables, and IDT performance accuracy as the dependent variable.||0.00065|-0.00350|0.178
72384910|NCT02642029|144277574|EQUIVALENCE|Tested the null hypothesis that there is no effect of condition (iTBS, cTBS, sham) on pre-post change in VAS scores.||||||0.33||||||Given the exploratory nature of this pilot study, we set the significance threshold at p \< 0.05, two-sided, without correcting for eight comparisons.|Friedman test|Non-parametric repeated measures ANOVA.||||||.330
72437216|NCT04707313|144387616|SUPERIORITY||Difference to Placebo|-12.87|STANDARD_ERROR_OF_MEAN|0.023|<|0.0001|TWO_SIDED|90.0|-16.15|-9.47|||Mixed Models Analysis||MMRM:treatment,time,strata(female vs male),treatment-by-time interaction as fixed effect, natural log-transformed baseline as covariate,natural log-transformed baseline-by-time interaction with time fitted:repeated effect, participant:random effect.|||-9.47|-16.15|<.0001
72437217|NCT04707313|144387629|SUPERIORITY|Logistic regression models (included terms for treatment, strata \[females versus males\] and baseline body weight as a covariate) were applied to the imputed datasets from the multiple imputation method above and parameter estimates were combined using standard multiple imputation techniques.|Odds Ratio (OR)|7.37|||||TWO_SIDED|90.0|2.81|19.3||||||||19.30|2.81|
72437218|NCT04707313|144387629|SUPERIORITY||Odds Ratio (OR)|6.58|||||TWO_SIDED|90.0|2.62|16.53||||||Logistic regression models (included terms for treatment, strata \[females versus males\] and baseline body weight as a covariate) were applied to the imputed datasets from the multiple imputation method above and parameter estimates were combined using standard multiple imputation techniques.||16.53|2.62|
72558471|NCT00112437|144646483|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-1.26||||0.344|TWO_SIDED|95.0|-19.9|17.39||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance|Difference in Least Squares Means (back-transformation of difference in log-fractions from baseline)|The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone resorption (u-DPyr) compared to placebo over 12 months. The secondary hypothesis states that odanacatib will decrease biochemical indices of bone resorption (u-DPyr) over 12 months.||17.39|-19.90|0.344
72437219|NCT04707313|144387629|SUPERIORITY||Odds Ratio (OR)|16.33|||||TWO_SIDED|90.0|6.47|41.24||||||Logistic regression models (included terms for treatment, strata \[females versus males\] and baseline body weight as a covariate) were applied to the imputed datasets from the multiple imputation method above and parameter estimates were combined using standard multiple imputation techniques.||41.24|6.47|
72437220|NCT04707313|144387629|SUPERIORITY|Logistic regression models (included terms for treatment, strata \[females versus males\] and baseline body weight as a covariate) were applied to the imputed datasets from the multiple imputation method above and parameter estimates were combined using standard multiple imputation techniques.|Odds Ratio (OR)|14.24|||||TWO_SIDED|90.0|5.39|37.66||||||||37.66|5.39|
72618777|NCT01026038|144768112|SUPERIORITY_OR_OTHER||Percent Difference|0.0|||||TWO_SIDED|95.0|-6.7|6.5||||||Serotype 23F: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 7vPnC/7vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/13vPnC/13vPnC along with exact 2-sided 95% CI.||6.5|-6.7|
72437221|NCT04707313|144387629|SUPERIORITY|Logistic regression models (included terms for treatment, strata \[females versus males\] and baseline body weight as a covariate) were applied to the imputed datasets from the multiple imputation method above and parameter estimates were combined using standard multiple imputation techniques.|Odds Ratio (OR)|30.17|||||TWO_SIDED|90.0|11.35|80.2||||||||80.20|11.35|
72437222|NCT04707313|144387629|SUPERIORITY|Logistic regression models (included terms for treatment, strata \[females versus males\] and baseline body weight as a covariate) were applied to the imputed datasets from the multiple imputation method above and parameter estimates were combined using standard multiple imputation techniques.|Odds Ratio (OR)|9.88|||||TWO_SIDED|90.0|2.91|33.53||||||||33.53|2.91|
72437223|NCT04707313|144387629|SUPERIORITY|Logistic regression models (included terms for treatment, strata \[females versus males\] and baseline body weight as a covariate) were applied to the imputed datasets from the multiple imputation method above and parameter estimates were combined using standard multiple imputation techniques.|Odds Ratio (OR)|24.41|||||TWO_SIDED|90.0|8.28|71.95||||||||71.95|8.28|
72437224|NCT04707313|144387629|SUPERIORITY|Logistic regression models (included terms for treatment, strata \[females versus males\] and baseline body weight as a covariate) were applied to the imputed datasets from the multiple imputation method above and parameter estimates were combined using standard multiple imputation techniques.|Odds Ratio (OR)|12.65|||||TWO_SIDED|90.0|4.56|35.08||||||||35.08|4.56|
72437225|NCT04707313|144387630|SUPERIORITY|Logistic regression models (included terms for treatment, strata \[females versus males\] and baseline body weight as a covariate) were applied to the imputed datasets from the multiple imputation method above and parameter estimates were combined using standard multiple imputation techniques.|Odds Ratio (OR)|33.43|||||TWO_SIDED|90.0|3.05|366.64||||||||366.64|3.05|
72437226|NCT04707313|144387630|SUPERIORITY|Logistic regression models (included terms for treatment, strata \[females versus males\] and baseline body weight as a covariate) were applied to the imputed datasets from the multiple imputation method above and parameter estimates were combined using standard multiple imputation techniques.|Odds Ratio (OR)|34.04|||||TWO_SIDED|90.0|3.1|373.85||||||||373.85|3.10|
72437227|NCT04707313|144387630|SUPERIORITY|Logistic regression models (included terms for treatment, strata \[females versus males\] and baseline body weight as a covariate) were applied to the imputed datasets from the multiple imputation method above and parameter estimates were combined using standard multiple imputation techniques.|Odds Ratio (OR)|127.21|||||TWO_SIDED|90.0|10.55|1533.46||||||||1533.46|10.55|
72437228|NCT03165175|144387641|SUPERIORITY|||||||0.72||||||This p-value is the for the group by time (group: intervention/control, by time: baseline/1 month) interaction.|ANOVA|||||||.72
72437229|NCT03165175|144387642|SUPERIORITY|||||||0.598||||||This p-value is the for the group by time (group: intervention/control, by time: baseline/1 month) interaction.|ANOVA|||||||.598
72437230|NCT03165175|144387643|SUPERIORITY|||||||0.954||||||This p-value is the for the group by time (group: intervention/control, by time: baseline/1 month) interaction.|ANOVA|||||||.954
72437231|NCT03165175|144387644|SUPERIORITY|||||||0.167||||||This p-value is the for the group by time (group: intervention/control, by time: baseline/1 month) interaction.|ANOVA|||||||.167
72437232|NCT03165175|144387645|SUPERIORITY|||||||0.022||||||This p-value is the for the group by time (group: intervention/control, by time: baseline/1 month) interaction.|ANOVA|||||||.022
72437233|NCT01215695|144387660|SUPERIORITY||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
72437234|NCT01215695|144387661|SUPERIORITY||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
72437235|NCT01215695|144387662|SUPERIORITY|||||||0.05|||||||Chi-squared|||||||0.05
72437236|NCT01215695|144387663|SUPERIORITY|||||||0.05|||||||Chi-squared|||||||0.05
72437237|NCT01215695|144387664|SUPERIORITY|||||||0.05|||||||Wilcoxon (Mann-Whitney)|||||||0.05
72437238|NCT01378065|144387745|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||t-test, 2 sided|||||||<.001
72437239|NCT01378065|144387746|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||t-test, 2 sided|||||||<.001
72437240|NCT01378065|144387747|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||t-test, 2 sided|||||||<.001
72437241|NCT01378065|144387748|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||t-test, 2 sided|||||||<.001
72437242|NCT01378065|144387749|SUPERIORITY_OR_OTHER_LEGACY|||||||0.202|TWO_SIDED||||||t-test, 2 sided|||||||0.202
72437243|NCT01378065|144387750|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|TWO_SIDED||||||t-test, 2 sided|||||||0.001
72437244|NCT01378065|144387751|SUPERIORITY_OR_OTHER_LEGACY|||||||0.004|TWO_SIDED||||||t-test, 2 sided|||||||0.004
72437245|NCT01378065|144387752|SUPERIORITY_OR_OTHER_LEGACY|||||||0.034|TWO_SIDED||||||t-test, 2 sided|||||||0.034
72558472|NCT00112437|144646483|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-1.33|||||TWO_SIDED|95.0|-20.55|17.89||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through a stepdown trend-test approach. Multiplicity for multiple endpoints was handle by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance|Difference in Least Squares Means (back-transformation of difference in log-fractions from baseline)|The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone resorption (u-DPyr) compared to placebo over 12 months. The secondary hypothesis states that odanacatib will decrease biochemical indices of bone resorption (u-DPyr) over 12 months.||17.89|-20.55|
72494971|NCT00848354|144519150|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.34|||<|0.0001|TWO_SIDED|95.0|3.18|8.96||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 12.||8.96|3.18|<0.0001
72494972|NCT00848354|144519150|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.7|||<|0.0001|TWO_SIDED|95.0|3.23|10.06||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 16.||10.06|3.23|<0.0001
72494973|NCT00848354|144519150|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|7.88|||<|0.0001|TWO_SIDED|95.0|4.37|14.2||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 20.||14.20|4.37|<0.0001
72494974|NCT00848354|144519150|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.73|||<|0.0001|TWO_SIDED|95.0|3.4|9.65||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 24.||9.65|3.40|<0.0001
72494975|NCT00848354|144519152|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-values. ANCOVA was ran at each time-point shown, however as p-values obtained were identical, only one p-value is presented (which is applicable to each time-point - Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 - independently).||||<0.0001
72494976|NCT00848354|144519154|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-values. ANCOVA was ran at each time-point shown, however as p-values obtained were identical, only one p-value is presented (which is applicable to each time-point - Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 - independently).||||<0.0001
72494977|NCT00848354|144519156|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-values. ANCOVA was ran at each time-point shown, however as p-values obtained were identical, only one p-value is presented (which is applicable to each time-point - Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 - independently).||||<0.0001
72494978|NCT00848354|144519158|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-values. ANCOVA was ran at each time-point shown, however as p-values obtained were identical, only one p-value is presented (which is applicable to each time-point - Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 - independently).||||<0.0001
72494979|NCT00848354|144519160|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 2.||||<0.0001
72494980|NCT00848354|144519160|SUPERIORITY_OR_OTHER|||||||0.0007|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 4.||||0.0007
72494981|NCT00848354|144519160|SUPERIORITY_OR_OTHER|||||||0.0009|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 8.||||0.0009
72494982|NCT00848354|144519160|SUPERIORITY_OR_OTHER|||||||0.0007|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 12.||||0.0007
72558473|NCT00112437|144646483|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|28.15|||||TWO_SIDED|95.0|5.84|50.46||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through a stepdown trend-test approach. Multiplicity for multiple endpoints was handle by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance|Difference in Least Squares Means (back-transformation of difference in log-fractions from baseline)|The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone resorption (u-DPyr) compared to placebo over 12 months. The secondary hypothesis states that odanacatib will decrease biochemical indices of bone resorption (u-DPyr) over 12 months.||50.46|5.84|
72618778|NCT01026038|144768112|SUPERIORITY_OR_OTHER||Percent Difference|0.0|||||TWO_SIDED|95.0|-3.5|6.4||||||Serotype 1: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 13vPnC/13vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/7vPnC/13vPnC along with exact 2-sided 95% CI.||6.4|-3.5|
72618779|NCT01026038|144768112|SUPERIORITY_OR_OTHER||Percent Difference|0.0|||||TWO_SIDED|95.0|-3.6|6.3||||||Serotype 1: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 13vPnC/13vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/13vPnC/13vPnC along with exact 2-sided 95% CI.||6.3|-3.6|
72437246|NCT01378065|144387753|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|TWO_SIDED||||||t-test, 2 sided|||Analysis baseline to 6 weeks.||||0.001
72437247|NCT01378065|144387754|SUPERIORITY_OR_OTHER_LEGACY|||||||0.004|TWO_SIDED||||||t-test, 2 sided|||Analysis baseline to 3 months.||||0.004
72437248|NCT01378065|144387755|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||t-test, 2 sided|||Analysis baseline to 6 months.||||<.001
72437249|NCT01378065|144387756|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||t-test, 2 sided|||Analysis baseline to 12 months.||||<.001
72437250|NCT00667745|144387791|SUPERIORITY||F value, main effect|0.94||||0.33|TWO_SIDED||||||Mixed Models Analysis|||||||0.33
72437251|NCT00667745|144387792|SUPERIORITY||Chi-squared|0.0||||0.967|TWO_SIDED||||||Chi-squared|||||||0.967
72437252|NCT00667745|144387793|SUPERIORITY||Mean Difference (Net)|0.45||||0.5|TWO_SIDED||||||Mixed Models Analysis|||||||0.50
72437253|NCT00667745|144387794|SUPERIORITY||Mean Difference (Net)|0.02||||0.88|TWO_SIDED||||||Mixed Models Analysis|||||||0.88
72437254|NCT00667745|144387795|SUPERIORITY||Mean Difference (Net)|0.92||||0.49|TWO_SIDED|||||Value shown above describes emergent suicidal ideation for participants with baseline MSSI = 0. P=.36 describes exacerbation of baseline suicidal ideation for those with baseline MSSI \> 0.|Mixed Models Analysis|||||||.49
72437255|NCT01713946|144387799|SUPERIORITY||Odds Ratio (OR)|2.21||||0.008|TWO_SIDED|95.0|1.16|4.2|||Bonferroni-Holm|||||4.20|1.16|0.008
72437256|NCT01713946|144387799|SUPERIORITY||Odds Ratio (OR)|3.93|||<|0.001|TWO_SIDED|95.0|2.1|7.32|||Bonferroni-Holm|||||7.32|2.10|<0.001
72437257|NCT01713946|144387800|SUPERIORITY||Median Difference (Final Values)|15.96||||0.003|TWO_SIDED|95.0|1.98|31.68|||Bonferroni-Holm|||||31.68|1.98|0.003
72437258|NCT01713946|144387800|SUPERIORITY||Odds Ratio (OR)|27.46|||<|0.001|TWO_SIDED|95.0|16.36|43.36|||Bonferroni-Holm|||||43.36|16.36|<0.001
72437259|NCT01713946|144387801|SUPERIORITY||Odds Ratio (OR)|6.55|||||TWO_SIDED|95.0|0.77|55.73||||||||55.73|0.77|
72437260|NCT01713946|144387801|SUPERIORITY||Odds Ratio (OR)|4.99|||||TWO_SIDED|95.0|0.57|44.03||||||||44.03|0.57|
72437261|NCT01713946|144387802|SUPERIORITY||Odds Ratio (OR)|1.77|||||TWO_SIDED|95.0|1.05|2.97||||||||2.97|1.05|
72437262|NCT01713946|144387802|SUPERIORITY||Odds Ratio (OR)|3.82|||||TWO_SIDED|95.0|2.25|6.48||||||||6.48|2.25|
72437263|NCT01713946|144387804|SUPERIORITY||Mean Difference (Final Values)|1.4|||||TWO_SIDED|95.0|-0.4|3.1||||||||3.1|-0.4|
72437264|NCT01713946|144387804|SUPERIORITY||Mean Difference (Final Values)|4.2|||||TWO_SIDED|95.0|2.5|5.9||||||||5.9|2.5|
72437265|NCT01713946|144387805|SUPERIORITY||Hazard Ratio (HR)|1.27|||||TWO_SIDED|95.0|0.77|2.07||||||||2.07|0.77|
72437266|NCT01713946|144387805|SUPERIORITY||Hazard Ratio (HR)|1.2|||||TWO_SIDED|95.0|0.74|1.96||||||||1.96|0.74|
72618780|NCT01026038|144768112|SUPERIORITY_OR_OTHER||Percent Difference|0.0|||||TWO_SIDED|95.0|-6.5|6.3||||||Serotype 1: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 7vPnC/7vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/13vPnC/13vPnC along with exact 2-sided 95% CI.||6.3|-6.5|
72437267|NCT01713946|144387806|SUPERIORITY||Difference in least square means|-1.1|||||TWO_SIDED|95.0|-4.4|2.1||||||||2.1|-4.4|
72437268|NCT01713946|144387806|SUPERIORITY||Difference in least square means|1.0|||||TWO_SIDED|95.0|-2.2|4.3||||||||4.3|-2.2|
72437269|NCT01713946|144387807|SUPERIORITY||Difference in least square means|-2.1|||||TWO_SIDED|95.0|-10.5|6.2||||||||6.2|-10.5|
72437270|NCT01713946|144387807|SUPERIORITY||Difference in least square means|0.4|||||TWO_SIDED|95.0|-7.8|8.6||||||||8.6|-7.8|
72437271|NCT01713946|144387808|SUPERIORITY||Difference in least square means|-2.8|||||TWO_SIDED|95.0|-17.9|12.3||||||||12.3|-17.9|
72437272|NCT01713946|144387808|SUPERIORITY||Difference in least square means|-7.7|||||TWO_SIDED|95.0|-22.0|6.6||||||||6.6|-22.0|
72437273|NCT04493242|144387840|OTHER|log-rank test||||||0.1343|||||||Chi-squared|||||||0.1343
72437274|NCT01942707|144387846|SUPERIORITY||Mean Difference (Final Values)|179.0|STANDARD_DEVIATION|222.0||0.003|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||0.003
72437275|NCT01942707|144387847|SUPERIORITY||Mean Difference (Final Values)|1.2|STANDARD_DEVIATION|1.9||0.012|TWO_SIDED|95.0|||||t-test, 2 sided|||||||0.012
72437276|NCT01942707|144387848|SUPERIORITY||Mean Difference (Final Values)|4.8|STANDARD_DEVIATION|40.7||0.809|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||0.809
72437277|NCT04541303|144387856|SUPERIORITY|||||||0.028|||||||None specified|||||||.028
72437278|NCT03538041|144387874|SUPERIORITY|||||||0.2815|||||||ANOVA|||Week 2||||0.2815
72437279|NCT03538041|144387875|SUPERIORITY|||||||0.2921|||||||Kruskal-Wallis|||Week 2||||0.2921
72437280|NCT03538041|144387876|SUPERIORITY|||||||0.1267|||||||ANOVA|||Week 2||||0.1267
72437281|NCT03538041|144387877|SUPERIORITY|||||||0.2676|||||||ANOVA|||Week 2||||0.2676
72437282|NCT00465816|144387946|NON_INFERIORITY|The lower limit of the two-sided 95% CI on the ratio of rSBA-MenA GMTs between Nimenrix + Twinrix group and (over) Nimenrix group was ≥ 0.5.|Adjusted GMT ratio|0.99|||||TWO_SIDED|95.0|0.8|1.22|||ANCOVA|||To assess the Non-inferiority in term of rSBA-MenA GMT of the Nimenrix + Twinrix group compared to Nimenrix one, two-sided 95% confidence interval (CI) from ANCOVA model on the GMTs ratio (Nimenrix+Twinrix group over Nimenrix group) was computed. The model was adjusted for age strata and baseline titre.||1.22|0.8|
72437283|NCT00465816|144387946|NON_INFERIORITY|The lower limit of the two-sided 95% CI on the ratio of rSBA-MenC GMTs between Nimenrix + Twinrix group and (over) Nimenrix group was ≥ 0.5.|Adjusted GMT ratio|0.91|||||TWO_SIDED|95.0|0.68|1.21|||ANCOVA|||To assess the Non-inferiority in term of rSBA-MenC GMT of the Nimenrix+Twinrix group compared to Nimenrix one, Two-sided 95% CI from ANCOVA model on the GMTs ratio (Nimenrix+Twinrix group over Nimenrix group) was computed. The model was adjusted for age strata and baseline titre.||1.21|0.68|
72437284|NCT00465816|144387946|NON_INFERIORITY|The lower limit of the two-sided 95% CI on the ratio of rSBA-MenW-135 GMTs between Nimenrix + Twinrix group and (over) Nimenrix group was ≥ 0.5.|Adjusted GMT ratio|1.02|||||TWO_SIDED|95.0|0.87|1.19|||ANCOVA|||To assess the Non-inferiority in term of rSBA-MenW-135 GMT of the Nimenrix+Twinrixg roup compared to Nimenrix one, Two-sided 95% CI from ANCOVA model on the GMTs ratio (Nimenrix+Twinrix group over Nimenrix group) was computed. The model was adjusted for age strata and baseline titre.||1.19|0.87|
72558474|NCT00112437|144646484|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-15.57|||<=|0.001|TWO_SIDED|95.0|-26.11|-5.04||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance.|Difference in Least Squares Means (back-transformation from difference in log-fraction from baseline)|The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone formation (s-BSAP) compared to placebo over 12 months.||-5.04|-26.11|<=0.001
72494983|NCT00848354|144519160|SUPERIORITY_OR_OTHER|||||||0.0005|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 16.||||0.0005
72384911|NCT02642029|144277574|OTHER||beta coefficient for delusions of contro|-0.00038||||0.777|TWO_SIDED|95.0|-0.00305|0.00228||Given the exploratory nature of this pilot study, we set the significance threshold at p \<0.05, two-sided, without correcting for eight comparisons.|Mixed Models Analysis|||We explored the association between interval discrimination task (IDT) performance (accuracy) and each symptom self-rating (here, delusions of control). We conducted a mixed effects regression analysis to test the null hypothesis of no association. Model included time (pre, post) and condition (iTBS vs. sham, cTBS vs. sham) in addition to symptom rating as independent variables, and IDT performance accuracy as the dependent variable.||0.00228|-0.00305|0.777
72384912|NCT00676338|144277583|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority Null Hypotheses: H1: The effect of exenatide is inferior to that of metformin. H2: The effect of exenatide is inferior to that of sitagliptin. H3: The effect of exenatide is inferior to that of pioglitazone. Then, the 3 superiority null hypotheses were tested. Change in HbA1c was analyzed using an MMRM analysis of covariance (ANCOVA) with treatment, baseline HbA1c, country, week of visit, and treatment-by week interaction as fixed effects; and patient and error as random effects.|Least Squares Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.09||0.62|TWO_SIDED|98.3|-0.26|0.17||Noninferiority was tested by Bonferroni (margin 0.3%, adjusted significance of 0.0167). Superiority was tested by Hommel (nominal significance level was between 0.0167 and 0.05 depended on the number of noninferiority hypotheses rejected).|Mixed Models Analysis|||Power calculation: A sample of 740 (222 exenatide once weekly, 222 metformin, 148 pioglitazone, and 148 sitagliptin) would provide approximately 90% power to detect a true differences between exenatide once weekly and the 3 comparators: metformin, pioglitazone, and sitagliptin of 0.4%, 0.5%, and 0.5%, respectively in change in HbA1c from baseline to Week 26 with a 2-sided t test at a significance level of 0.05, assuming a common standard deviation of 1.2%.||0.17|-0.26|0.620
72384913|NCT00676338|144277583|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority Null Hypotheses: H1: The effect of exenatide is inferior to that of metformin. H2: The effect of exenatide is inferior to that of sitagliptin. H3: The effect of exenatide is inferior to that of pioglitazone. Then, the 3 superiority null hypotheses were tested. Change in HbA1c was analyzed using an MMRM analysis of covariance (ANCOVA) with treatment, baseline HbA1c, country, week of visit, and treatment-by week interaction as fixed effects; and patient and error as random effects.|Least Squares Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.1||0.328|TWO_SIDED|98.3|-0.15|0.35||Noninferiority was tested by Bonferroni (margin 0.3%, adjusted significance of 0.0167). Superiority was tested by Hommel (nominal significance level was between 0.0167 and 0.05 depended on the number of noninferiority hypotheses rejected).|Mixed Models Analysis|||Power calculation: A sample of 740 (222 exenatide once weekly, 222 metformin, 148 pioglitazone, and 148 sitagliptin) would provide approximately 90% power to detect a true differences between exenatide once weekly and the 3 comparators: metformin, pioglitazone, and sitagliptin of 0.4%, 0.5%, and 0.5%, respectively in change in HbA1c from baseline to Week 26 with a 2-sided t test at a significance level of 0.05, assuming a common standard deviation of 1.2%.||0.35|-0.15|0.328
72437285|NCT00465816|144387946|NON_INFERIORITY|The lower limit of the two-sided 95% CI on the ratio of rSBA-MenY GMTs between Nimenrix + Twinrix group and (over) Nimenrix group was ≥ 0.5.|Adjusted GMT ratio|1.01|||||TWO_SIDED|95.0|0.85|1.19|||ANCOVA|||To assess the Non-inferiority in term of rSBA-MenY GMT of the Nimenrix+Twinrix group compared to Nimenrix one, Two-sided 95% CI from ANCOVA model on the GMTs ratio (Nimenrix+Twinrix group over Nimenrix group) was computed. The model was adjusted for age strata and baseline titre.||1.19|0.85|
72437286|NCT00465816|144387947|NON_INFERIORITY|The lower limit of the two-sided standardised asymptotic 95% CI for group difference (Nimenrix+Twinrix group minus Twinrix group) in the percentage of subjects with vaccine seroconversion was ≥ pre-defined clinical limit of -10%.|Percentage difference|0.0|||||TWO_SIDED|95.0|-1.19|3.9||||||To assess the Non-inferiority of the Nimenrix+Twinrix group compared to Twinrix one, two-sided standardized asymptotic 95% CI for the difference in seroconversion rates for hepatitis A (Nimenrix+Twinrix group minus Twinrix group) was computed.||3.9|-1.19|
72437287|NCT00465816|144387948|NON_INFERIORITY|The lower limit of the two-sided standardised asymptotic 95% CI for group difference (Nimenrix+Twinrix group minus Twinrix group) in the percentage of subjects with vaccine seroconversion was ≥ pre-defined clinical limit of -10%.|Percentage difference|-0.91|||||TWO_SIDED|95.0|-2.64|2.92||||||To assess the Non-inferiority of the Nimenrix+Twinrix group compared to the Twinrix one, two-sided standardized asymptotic 95% CI for the difference in seroprotection rates for hepatitis B (Nimenrix+Twinrix group minus Twinrix group) was computed.||2.92|-2.64|
72437288|NCT00004124|144388001|SUPERIORITY||Hazard Ratio (HR)|1.06||||0.7|TWO_SIDED|95.0|0.79|1.43|||Regression, Cox|||||1.43|0.79|0.70
72437289|NCT00004124|144388002|SUPERIORITY||Hazard Ratio (HR)|1.01||||0.94|TWO_SIDED|95.0|0.8|1.27|||Regression, Cox|||||1.27|0.80|0.94
72437290|NCT00807144|144388007|SUPERIORITY|||||||0.26|||||||Log Rank|||||||0.26
72437291|NCT00807144|144388008|SUPERIORITY|||||||0.48|||||||Log Rank|||Year 1||||0.48
72437292|NCT00807144|144388008|SUPERIORITY|||||||0.75|||||||Log Rank|||Year 2||||0.75
72437293|NCT00432458|144388014|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||Log Rank|Model was stratified by beta-2 microglobulin (high vs low), lytic bone lesions (present vs not) and bone marrow labeling index (high vs low)||||||0.02
72437294|NCT00432458|144388015|SUPERIORITY_OR_OTHER|||||||0.0048||95.0|||||Chi-squared|||||||0.0048
72437295|NCT00432458|144388016|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||||||<0.001
72494984|NCT00848354|144519160|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 20.||||<0.0001
72558475|NCT00112437|144646484|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|5.43||||0.645|TWO_SIDED|95.0|-6.02|16.89||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance.|Difference in Least Squares Means (back-transformation from difference in log-fraction from baseline)|The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone formation (s-BSAP) compared to placebo over 12 months.||16.89|-6.02|0.645
72494985|NCT00848354|144519160|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 24.||||<0.0001
72494986|NCT00848354|144519162|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-values. ANCOVA was ran at each time-point shown, however as p-values obtained were identical, only one p-value is presented (which is applicable to each time-point - Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 - independently).||||<0.0001
72494987|NCT00848354|144519164|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-values. ANCOVA was ran at each time-point shown, however as p-values obtained were identical, only one p-value is presented (which is applicable to each time-point - Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 - independently).||||<0.0001
72494988|NCT00848354|144519166|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-values. ANCOVA was ran at each time-point shown, however as p-values obtained were identical, only one p-value is presented (which is applicable to each time-point - Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 - independently).||||<0.0001
72494989|NCT00848354|144519168|SUPERIORITY_OR_OTHER|||||||0.1975|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value.||||0.1975
72494990|NCT00848354|144519169|SUPERIORITY_OR_OTHER|||||||0.0044|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value.||||0.0044
72558476|NCT00112437|144646484|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|11.73|||||TWO_SIDED|95.0|-0.47|23.92||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handle by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance.|Difference in Least Squares Means (back-transformation from difference in log-fraction from baseline)|The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone formation (s-BSAP) compared to placebo over 12 months.||23.92|-0.47|
72494991|NCT00848354|144519170|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-values. ANCOVA was ran at each time-point shown, however as p-values obtained were identical, only one p-value is presented (which is applicable to each time-point - Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 - independently).||||<0.0001
72494992|NCT00848354|144519172|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 2.||||<0.0001
72494993|NCT00848354|144519172|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 4.||||<0.0001
72494994|NCT00848354|144519172|SUPERIORITY_OR_OTHER|||||||0.0002|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 8.||||0.0002
72494995|NCT00848354|144519172|SUPERIORITY_OR_OTHER|||||||0.0007|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 12.||||0.0007
72494996|NCT00848354|144519172|SUPERIORITY_OR_OTHER|||||||0.0001|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 16.||||0.0001
72618781|NCT01026038|144768112|SUPERIORITY_OR_OTHER||Percent Difference|1.8|||||TWO_SIDED|95.0|-1.7|9.6||||||Serotype 3: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 13vPnC/13vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/7vPnC/13vPnC along with exact 2-sided 95% CI.||9.6|-1.7|
72384914|NCT00676338|144277583|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority Null Hypotheses: H1: The effect of exenatide is inferior to that of metformin. H2: The effect of exenatide is inferior to that of sitagliptin. H3: The effect of exenatide is inferior to that of pioglitazone. Then, the 3 superiority null hypotheses were tested. Change in HbA1c was analyzed using an MMRM analysis of covariance (ANCOVA) with treatment, baseline HbA1c, country, week of visit, and treatment-by week interaction as fixed effects; and patient and error as random effects.|Least Squares Mean Difference|-0.37|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|98.3|-0.62|-0.13||Noninferiority was tested by Bonferroni (margin 0.3%, adjusted significance of 0.0167). Superiority was tested by Hommel (nominal significance level was between 0.0167 and 0.05 depended on the number of noninferiority hypotheses rejected).|Mixed Models Analysis|||Power calculation: A sample of 740 (222 exenatide once weekly, 222 metformin, 148 pioglitazone, and 148 sitagliptin) would provide approximately 90% power to detect a true differences between exenatide once weekly and the 3 comparators: metformin, pioglitazone, and sitagliptin of 0.4%, 0.5%, and 0.5%, respectively in change in HbA1c from baseline to Week 26 with a 2-sided t test at a significance level of 0.05, assuming a common standard deviation of 1.2%.||-0.13|-0.62|<.001
72384915|NCT00676338|144277584|SUPERIORITY_OR_OTHER|||||||0.151|TWO_SIDED|||||No multiple adjustment were done.|Fisher Exact|||||||0.151
72384916|NCT00676338|144277584|SUPERIORITY_OR_OTHER|||||||0.913|TWO_SIDED|||||No multiple adjustment were done.|Fisher Exact|||||||0.913
72384917|NCT00676338|144277584|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||No multiple adjustment were done.|Fisher Exact|||||||<.001
72384918|NCT00676338|144277585|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.28|STANDARD_ERROR_OF_MEAN|0.19||0.155|TWO_SIDED|95.0|-0.66|0.1||No multiple adjustment were done.|Mixed Models Analysis|||Change in FSG from baseline to Week 26 was analyzed using an MMRM ANCOVA model with treatment, baseline FSG, country, week of visit, and treatment-by week interaction as fixed effects; and patient and error as random effects.||0.10|-0.66|0.155
72384919|NCT00676338|144277585|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.32|STANDARD_ERROR_OF_MEAN|0.22||0.153|TWO_SIDED|95.0|-0.12|0.75||No multiple adjustment were done.|Mixed Models Analysis|||Change in FSG from baseline to Week 26 was analyzed using an MMRM ANCOVA model with treatment, baseline FSG, country, week of visit, and treatment-by week interaction as fixed effects; and patient and error as random effects.||0.75|-0.12|0.153
72384920|NCT00676338|144277585|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-1.12|STANDARD_ERROR_OF_MEAN|0.22|<|0.001|TWO_SIDED|95.0|-1.56|-0.68||No multiple adjustment were done.|Mixed Models Analysis|||Change in FSG from baseline to Week 26 was analyzed using an MMRM ANCOVA model with treatment, baseline FSG, country, week of visit, and treatment-by week interaction as fixed effects; and patient and error as random effects.||-0.68|-1.56|<.001
72384921|NCT00676338|144277586|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.29||0.892|TWO_SIDED|95.0|-0.61|0.53||No multiple adjustment were done.|Mixed Models Analysis|||Change in Body Weight from baseline to Week 26 was analyzed using an MMRM ANCOVA model with treatment, baseline body weight, country, week of visit, and treatment-by week interaction as fixed effects; and patient and error as random effects.||0.53|-0.61|0.892
72384922|NCT00676338|144277586|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-3.56|STANDARD_ERROR_OF_MEAN|0.33|<|0.001|TWO_SIDED|95.0|-4.21|-2.9||No multiple adjustment were done.|Mixed Models Analysis|||Change in Body Weight from baseline to Week 26 was analyzed using an MMRM ANCOVA model with treatment, baseline body weight, country, week of visit, and treatment-by week interaction as fixed effects; and patient and error as random effects.||-2.90|-4.21|<.001
72384923|NCT00676338|144277586|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-1.28|STANDARD_ERROR_OF_MEAN|0.33|<|0.001|TWO_SIDED|95.0|-1.92|-0.63||No multiple adjustment were done.|Mixed Models Analysis|||Change in Body Weight from baseline to Week 26 was analyzed using an MMRM ANCOVA model with treatment, baseline body weight, country, week of visit, and treatment-by week interaction as fixed effects; and patient and error as random effects.||-0.63|-1.92|<.001
72384924|NCT00676338|144277587|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.08||0.873|TWO_SIDED|95.0|-0.18|0.15||No multiple adjustment were done.|Mixed Models Analysis|||Change in Fasting TC from baseline to Week 26 was analyzed using an MMRM ANCOVA model with treatment, baseline TC, country, week of visit, and treatment-by week interaction as fixed effects; and patient and error as random effects.||0.15|-0.18|0.873
72384925|NCT00676338|144277587|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.33|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.52|-0.14||No multiple adjustment were done.|Mixed Models Analysis|||Change in Fasting TC from baseline to Week 26 was analyzed using an MMRM ANCOVA model with treatment, baseline TC, country, week of visit, and treatment-by week interaction as fixed effects; and patient and error as random effects.||-0.14|-0.52|<.001
72384926|NCT00676338|144277587|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.1||0.022|TWO_SIDED|95.0|-0.41|-0.03||No multiple adjustment were done.|Mixed Models Analysis|||Change in Fasting TC from baseline to Week 26 was analyzed using an MMRM ANCOVA model with treatment, baseline TC, country, week of visit, and treatment-by week interaction as fixed effects; and patient and error as random effects.||-0.03|-0.41|0.022
72384927|NCT00676338|144277588|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.02||0.004|TWO_SIDED|95.0|-0.09|-0.02||No multiple adjustment were done.|Mixed Models Analysis|||Change in Fasting HDL from baseline to Week 26 was analyzed using an MMRM ANCOVA model with treatment, baseline HDL, country, week of visit, and treatment-by week interaction as fixed effects; and patient and error as random effects.||-0.02|-0.09|0.004
72384928|NCT00676338|144277588|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.02|<|0.001|TWO_SIDED|95.0|-0.19|-0.11||No multiple adjustment were done.|Mixed Models Analysis|||Change in Fasting HDL from baseline to Week 26 was analyzed using an MMRM ANCOVA model with treatment, baseline HDL, country, week of visit, and treatment-by week interaction as fixed effects; and patient and error as random effects.||-0.11|-0.19|<.001
72437296|NCT01290224|144388023|NON_INFERIORITY_OR_EQUIVALENCE|A one-sided McNemar's test of the primary endpoint with 10 patients will have 86% power at 5% Type I error rate to detect a 60% difference in the percentage of at least 50% reduction in the scrambler and sham procedure, based on the assumption that the proportion of discordant pairs is at 70%.||||||0.763||95.0|||||McNemar|||McNemar's test was used to test for a difference between Scrambler and Sham procedure in their success rate.||||0.7630
72437297|NCT00346333|144388039|SUPERIORITY_OR_OTHER|||||||0.66||||||A priori threshold for statistical significance= 0.05. Annual assessments of data by data monitoring board were done with p-values adjusted using the O'Brien-Fleming rule for intermediate looks.|Longitudinal regression analysis|||"Primary Analysis:Proc mixed of the Statistical Analysis System (SAS) was used to compare annual rates of change by treatment group over 4 years.~Power Calculation:240 patients were estimated to be needed to provide sufficient power (i.e. alpha=0.05;beta=0.10)to observe a statistically significant difference between mean change in the 2 groups on the HFA 30-2 total point score over a 4-year interval."||||0.66
72437298|NCT00346333|144388039|SUPERIORITY_OR_OTHER|||||||0.52||||||A priori threshold for statistical significance= 0.05. Annual assessments of data by data monitoring board were done with p-values adjusted using the O'Brien-Fleming rule for intermediate looks.|Clustered Wilcoxon|||Secondary Analysis: As change distribution was non-normal, slope for each eye was calculated with least squares regression and converted to ranks. The Clustered Wilcoxon test was used to compare slope distributions between groups accounting for correlation between slopes for eyes within individuals.||||0.52
72437299|NCT00346333|144388040|SUPERIORITY_OR_OTHER|||||||0.05||95.0||||A priori threshold for statistical significance= 0.05. Annual assessments of data by data monitoring board were done with p-values adjusted using the O'Brien-Fleming rule for intermediate looks.|Longitudinal regression analysis|||Primary Analysis: Proc Mixed of SAS was used to compare annual rates of change by treatment group over four years.The unit of analysis was the eye. Each patient contributed 2, 1, or 0 eyes with non-missing data.||||0.05
72437300|NCT00346333|144388040|SUPERIORITY_OR_OTHER|||||||0.03||||||A priori threshold for statistical significance= 0.05. Annual assessments of data by data monitoring board were done with p-values adjusted using the O'Brien-Fleming rule for intermediate looks.|Clustered Wilcoxon|||Secondary Analysis: As change distribution was non-normal, slope for each eye was calculated with least squares regression and converted to ranks. The Clustered Wilcoxon test was used to compare slope distributions between groups accounting for correlation between slopes for eyes within individuals.||||0.03
72437301|NCT00346333|144388041|SUPERIORITY_OR_OTHER|||||||0.24||||||A priori threshold for statistical significance= 0.05. Annual assessments of data by data monitoring board were done with p-values adjusted using the O'Brien-Fleming rule for intermediate looks.|Longitudinal regression analysis|||Primary analysis:Proc Mixed of SAS was used to compare annual rates of change by treatment group over four years.The unit of analysis was the eye.Each patient contributed 2,1,or 0 eyes with non-missing data.||||0.24
72494997|NCT00848354|144519172|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 20.||||<0.0001
72494998|NCT00848354|144519172|SUPERIORITY_OR_OTHER|||||||0.0021|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 24.||||0.0021
72494999|NCT00848354|144519173|SUPERIORITY_OR_OTHER|||||||0.0001|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 8.||||0.0001
72495000|NCT00848354|144519173|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 16.||||<0.0001
72495001|NCT00848354|144519173|SUPERIORITY_OR_OTHER|||||||0.0003|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 24.||||0.0003
72495002|NCT00848354|144519175|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 8.||||<0.0001
72495003|NCT00848354|144519175|SUPERIORITY_OR_OTHER|||||||0.0264|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 16.||||0.0264
72495004|NCT00848354|144519175|SUPERIORITY_OR_OTHER|||||||0.0002|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 24.||||0.0002
72495005|NCT00848354|144519177|SUPERIORITY_OR_OTHER|||||||0.0005|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 8.||||0.0005
72495006|NCT00848354|144519177|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 16.||||<0.0001
72558477|NCT00112437|144646484|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|44.85|||||TWO_SIDED|95.0|30.55|59.16||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through a stepdown trend-test approach. Multiplicity for multiple endpoints was handle by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance.|Difference in Least Squares Means (back-transformation from difference in log-fraction from baseline)|The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone formation (s-BSAP) compared to placebo over 12 months.||59.16|30.55|
72558478|NCT00112437|144646485|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-35.74|||<=|0.001|TWO_SIDED|95.0|-52.14|-19.33||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance.|Difference in Least Squares Means (back-transformation of difference in log-fraction from baseline)|The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone formation (s-P1NP) compared to placebo over 12 months.||-19.33|-52.14|<=0.001
72558479|NCT00112437|144646485|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-1.68||||0.161|TWO_SIDED|95.0|-20.58|17.23||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance.|Difference in Least Squares Means (back-transformation of difference in log-fraction from baseline)|The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone formation (s-P1NP) compared to placebo over 12 months.||17.23|-20.58|0.161
72558480|NCT00112437|144646485|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-1.58|||||TWO_SIDED|95.0|-20.99|17.82||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handle by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance.|Difference in Least Squares Means (back-transformation of difference in log-fraction from baseline)|The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone formation (s-P1NP) compared to placebo over 12 months.||17.82|-20.99|
72558481|NCT00112437|144646485|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|46.9|||||TWO_SIDED|95.0|22.35|71.44||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handle by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance.|Difference in Least Squares Means (back-transformation of difference in log-fraction from baseline)|The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone formation (s-P1NP) compared to placebo over 12 months.||71.44|22.35|
72558482|NCT00112437|144646486|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|4.1|||<=|0.001|TWO_SIDED|95.0|2.77|5.42||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on total hip BMD compared to placebo over 24 months. The secondary hypothesis states that odanacatib will increase total hip BMD compared to placebo over 24 months.||5.42|2.77|<=0.001
72618782|NCT01026038|144768112|SUPERIORITY_OR_OTHER||Percent Difference|0.0|||||TWO_SIDED|95.0|-3.7|6.2||||||Serotype 3: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 13vPnC/13vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/13vPnC/13vPnC along with exact 2-sided 95% CI.||6.2|-3.7|
72384929|NCT00676338|144277588|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.02||0.142|TWO_SIDED|95.0|-0.07|0.01||No multiple adjustment were done.|Mixed Models Analysis|||Change in Fasting HDL from baseline to Week 26 was analyzed using an MMRM ANCOVA model with treatment, baseline HDL, country, week of visit, and treatment-by week interaction as fixed effects; and patient and error as random effects.||0.01|-0.07|0.142
72384930|NCT00676338|144277589|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean Ratio|1.02|STANDARD_ERROR_OF_MEAN|0.04||0.657|TWO_SIDED|95.0|0.94|1.1||No multiple adjustment were done.|ANCOVA|||Fasting triglycerides data were logarithm-transformed and the change at Week 26 to baseline, expressed as the ratio, was analyzed using ANCOVA model with treatment and country as factors and baseline triglycerides as a covariate.||1.10|0.94|0.657
72384931|NCT00676338|144277589|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean Ratio|1.16|STANDARD_ERROR_OF_MEAN|0.05||0.002|TWO_SIDED|95.0|1.06|1.27||No multiple adjustment were done.|ANCOVA|||Fasting triglycerides data were logarithm-transformed and the change at Week 26 to baseline, expressed as the ratio, was analyzed using ANCOVA model with treatment and country as factors and baseline triglycerides as a covariate.||1.27|1.06|0.002
72384932|NCT00676338|144277589|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean Ratio|1.04|STANDARD_ERROR_OF_MEAN|0.05||0.398|TWO_SIDED|95.0|0.95|1.14||No multiple adjustment were done.|ANCOVA|||Fasting triglycerides data were logarithm-transformed and the change at Week 26 to baseline, expressed as the ratio, was analyzed using ANCOVA model with treatment and country as factors and baseline triglycerides as a covariate.||1.14|0.95|0.398
72618783|NCT01026038|144768112|SUPERIORITY_OR_OTHER||Percent Difference|-1.8|||||TWO_SIDED|95.0|-9.6|4.5||||||Serotype 3: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 7vPnC/7vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/13vPnC/13vPnC along with exact 2-sided 95% CI.||4.5|-9.6|
72495007|NCT00848354|144519177|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 24.||||<0.0001
72495008|NCT00848354|144519179|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-values. ANCOVA was ran at each time-point shown, however as p-values obtained were identical, only one p-value is presented (which is applicable to each time-point - Week 8, Week 16, and Week 24 - independently).||||<0.0001
72495009|NCT00848354|144519180|SUPERIORITY_OR_OTHER|||||||0.0061|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 8.||||0.0061
72495010|NCT00848354|144519180|SUPERIORITY_OR_OTHER|||||||0.073|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 16.||||0.0730
72495011|NCT00848354|144519180|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 24.||||<0.0001
72495012|NCT00848354|144519181|SUPERIORITY_OR_OTHER|||||||0.0066|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 8.||||0.0066
72495013|NCT00848354|144519181|SUPERIORITY_OR_OTHER|||||||0.0036|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 16.||||0.0036
72495014|NCT00848354|144519181|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 24.||||<0.0001
72495015|NCT00848354|144519182|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 8.||||<0.0001
72495016|NCT00848354|144519182|SUPERIORITY_OR_OTHER|||||||0.0013|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 16.||||0.0013
72495017|NCT00848354|144519182|SUPERIORITY_OR_OTHER|||||||0.0002|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 24.||||0.0002
72495018|NCT00848354|144519183|SUPERIORITY_OR_OTHER|||||||0.0021|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 8.||||0.0021
72495019|NCT00848354|144519183|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 16.||||<0.0001
72495020|NCT00848354|144519183|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 24.||||<0.0001
72495021|NCT00848354|144519184|SUPERIORITY_OR_OTHER|||||||0.0062|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 8.||||0.0062
72495022|NCT00848354|144519184|SUPERIORITY_OR_OTHER|||||||0.0007|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 16.||||0.0007
72495023|NCT00848354|144519184|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 24.||||<0.0001
72495024|NCT00848354|144519185|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 8.||||<0.0001
72618784|NCT01026038|144768112|SUPERIORITY_OR_OTHER||Percent Difference|2.8|||||TWO_SIDED|95.0|-2.0|11.3||||||Serotype 5: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 13vPnC/13vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/7vPnC/13vPnC along with exact 2-sided 95% CI.||11.3|-2.0|
72558483|NCT00112437|144646486|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|3.48|||<=|0.001|TWO_SIDED|95.0|2.2|4.77||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through a stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on total hip BMD compared to placebo over 24 months. The secondary hypothesis states that odanacatib will increase total hip BMD compared to placebo over 24 months.||4.77|2.20|<=0.001
72437302|NCT00346333|144388041|SUPERIORITY_OR_OTHER|||||||0.2||||||Apriori threshold for statistical significance= 0.05. Annual assessments of data by data monitoring board were done with p-values adjusted using the O'Brien-Fleming rule for intermediate looks.|Clustered Wilcoxon|||Secondary Analysis: As change distribution was non-normal, slope for each eye was calculated with least squares regression and converted to ranks. The Clustered Wilcoxon test was used to compare slope distributions between groups accounting for correlation between slopes for eyes within individuals.||||0.20
72558484|NCT00112437|144646486|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|2.75|||<=|0.001|TWO_SIDED|95.0|1.43|4.07||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on total hip BMD compared to placebo over 24 months. The secondary hypothesis states that odanacatib will increase total hip BMD compared to placebo over 24 months.||4.07|1.43|<=0.001
72558485|NCT00112437|144646486|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-0.51||||0.536|TWO_SIDED|95.0|-1.84|0.83||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on total hip BMD compared to placebo over 24 months. The secondary hypothesis states that odanacatib will increase total hip BMD compared to placebo over 24 months.||0.83|-1.84|0.536
72618785|NCT01026038|144768112|SUPERIORITY_OR_OTHER||Percent Difference|-0.8|||||TWO_SIDED|95.0|-4.9|5.6||||||Serotype 5: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 13vPnC/13vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/13vPnC/13vPnC along with exact 2-sided 95% CI.||5.6|-4.9|
72495025|NCT00848354|144519185|SUPERIORITY_OR_OTHER|||||||0.0073|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 16.||||0.0073
72437303|NCT00346333|144388042|SUPERIORITY_OR_OTHER|||||||0.59||||||A priori threshold for statistical significance= 0.05. Annual assessments of data by data monitoring board were done with p-values adjusted using the O'Brien-Fleming rule for intermediate looks.|Longitudinal regression analysis|||Proc MIXED of SAS was used to compare annual rates of change over four years between the treatment groups.||||0.59
72437304|NCT00346333|144388043|SUPERIORITY_OR_OTHER|||||||0.8||||||A priori threshold for statistical significance= 0.05. Annual assessments of data by data monitoring board were done with p-values adjusted using the O'Brien-Fleming rule for intermediate looks.|Longitudinal regression analysis|||Proc MIXED of SAS was used to compare annual rates of change over 4 years between the 2 groups.||||0.80
72437305|NCT05565391|144388112|OTHER||Risk Ratio (RR)|1.95|||<|0.0001|TWO_SIDED|95.0|1.54|2.47|||Log-binomial regression model||Unweighted RRs were estimated using a log-binomial regression model with Wald confidence intervals.|||2.47|1.54|<.0001
72437306|NCT05565391|144388112|OTHER||Risk Ratio (RR)|2.01|||<|0.0001|TWO_SIDED|95.0|1.52|2.67|||Log-binomial regression model||Unweighted RRs were estimated using a log-binomial regression model with Wald confidence intervals.|||2.67|1.52|<.0001
72437307|NCT05565391|144388113|OTHER||Risk Ratio (RR)|2.22|||<|0.0001|TWO_SIDED|95.0|1.69|2.9|||Log-binomial regression model||Risk ratio was estimated using a log-binomial regression model and confidence interval was estimated using robust error variance.|||2.90|1.69|<.0001
72437308|NCT05565391|144388114|OTHER||Risk Ratio (RR)|1.79||||0.0447|TWO_SIDED|95.0|1.01|3.15|||Log-binomial regression model||Risk ratio was estimated using a log-binomial regression model and confidence interval was estimated using robust error variance.|||3.15|1.01|0.0447
72437309|NCT05565391|144388115|OTHER|||||||0.4241|||||||Quantile regression|||||||0.4241
72437310|NCT05565391|144388115|OTHER|||||||0.0281|||||||Quantile regression|||||||0.0281
72437311|NCT05565391|144388116|OTHER|||||||0.7682|||||||Quantile regression|||||||0.7682
72437312|NCT05565391|144388117|OTHER|||||||0.0326|||||||Quantile regression|||||||0.0326
72437313|NCT05565391|144388118|OTHER||Hazard Ratio (HR)|0.17|||<|0.0001|TWO_SIDED|95.0|0.09|0.31|||Cox proportional hazard model||Hazard ratio was estimated using unadjusted Cox proportional hazard model.|||0.31|0.09|<.0001
72437314|NCT05565391|144388118|OTHER||Hazard Ratio (HR)|0.22|||<|0.0001|TWO_SIDED|95.0|0.11|0.43|||Cox proportional hazard model||Hazard ratio was estimated using unadjusted Cox proportional hazard model.|||0.43|0.11|<.0001
72437315|NCT05565391|144388119|OTHER||Hazard Ratio (HR)|0.11|||<|0.0001|TWO_SIDED|95.0|0.06|0.22|||Cox proportional hazard model||Hazard ratio was estimated using weighted Cox proportional hazard model and confidence interval was estimated using robust error variance.|||0.22|0.06|<.0001
72437316|NCT05565391|144388120|OTHER||Hazard Ratio (HR)|0.21|||<|0.0001|TWO_SIDED|95.0|0.1|0.45|||Weighted Cox proportional hazard model||Hazard ratio was estimated using weighted Cox proportional hazard model and confidence interval was estimated using robust error variance.|||0.45|0.10|<.0001
72437317|NCT02716324|144388122|SUPERIORITY||Beta Coefficient|0.001||||0.871|TWO_SIDED|95.0|-0.01|0.012|||GLS random-effects model|||Random effects models regressed VPRS scores on intervention status, time (days), intervention by time, season, and clustered by doctor's office. We examined intervention X time interaction term for statistical significance.||0.012|-0.010|.871
72495026|NCT00848354|144519185|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 24.||||<0.0001
72437318|NCT02716324|144388123|SUPERIORITY||Beta coefficient|0.001||||0.499|TWO_SIDED|95.0|-0.002|0.004|||Random effects model|||Random effects models regressed GAS scores on intervention status, time (days), intervention by time, season, and clustered by doctor's office. We examined intervention X time interaction term for statistical significance.||0.004|-0.002|0.499
72437319|NCT02716324|144388124|SUPERIORITY|||||||0.718|||||||Chi-squared|||Differences in proportions between the two groups in use of any services were assessed using the Chi-square Test.||||0.718
72437320|NCT02716324|144388124|SUPERIORITY|||||||0.903|||||||Chi-squared|||Differences in proportions between the two groups in use of ambulatory mental health services were assessed using the Chi-square Test.||||0.903
72495027|NCT04202679|144519206|SUPERIORITY||Odds Ratio (OR)|2.3||||0.0216|TWO_SIDED|95.0|1.08|5.0||Threshold of significance at 0.05 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg q2w versus Placebo|A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measures were reported and continued when primary outcome measure was statistically significant at two-sided 0.05.||5.00|1.08|0.0216
72495028|NCT04202679|144519207|SUPERIORITY||Odds Ratio (OR)|9.0|||<|0.0001|TWO_SIDED|95.0|3.56|22.66||Threshold of significance at 0.05 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg q2w versus Placebo|A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measures were reported and continued when previous outcome measure was statistically significant at two-sided 0.05.||22.66|3.56|<0.0001
72495029|NCT04202679|144519208|SUPERIORITY||Odds Ratio (OR)|4.4|||<|0.0001|TWO_SIDED|95.0|2.02|9.55||Threshold of significance at 0.05 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg q2w versus Placebo|A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measures were reported and continued when previous outcome measure was statistically significant at two-sided 0.05.||9.55|2.02|<0.0001
72495030|NCT04202679|144519209|SUPERIORITY||Odds Ratio (OR)|6.1||||0.0001|TWO_SIDED|95.0|2.03|18.11||Threshold of significance at 0.05 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg q2w versus Placebo|A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measures were reported and continued when previous outcome measure was statistically significant at two-sided 0.05||18.11|2.03|0.0001
72495031|NCT04202679|144519210|SUPERIORITY||Odds Ratio (OR)|2.9||||0.0194|TWO_SIDED|95.0|1.13|7.52||Threshold of significance at 0.05 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg q2w versus Placebo|A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measures were reported and continued when previous outcome measure was statistically significant at two-sided 0.05.||7.52|1.13|0.0194
72495032|NCT04202679|144519211|SUPERIORITY||LS mean difference|-23.16|||<|0.0001|TWO_SIDED|95.0|-33.81|-12.51||Threshold of significance at 0.05 level.|ANCOVA||Dupilumab 300 mg q2w versus Placebo|A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measures were reported and continued when previous outcome measure was statistically significant at two-sided 0.05.||-12.51|-33.81|<0.0001
72495033|NCT04202679|144519212|SUPERIORITY||LS mean difference|-6.39|||<|0.0001|TWO_SIDED|95.0|-8.42|-4.36||Threshold of significance at 0.05 level.|ANCOVA||Dupilumab 300 mg q2w versus Placebo|A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measures were reported and continued when previous outcome measure was statistically significant at two-sided 0.05.||-4.36|-8.42|<0.0001
72495034|NCT04202679|144519213|SUPERIORITY||LS mean difference|-1.61||||0.0003|TWO_SIDED|95.0|-2.49|-0.73||Threshold of significance at 0.05 level.|ANCOVA||Dupilumab 300 mg q2w versus Placebo|A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measures were reported and continued when previous outcome measure was statistically significant at two-sided 0.05.||-0.73|-2.49|0.0003
72495035|NCT04202679|144519214|SUPERIORITY||LS mean difference|0.54||||0.1658|TWO_SIDED|95.0|-0.22|1.3||Threshold of significance at 0.05 level.|ANCOVA||Dupilumab 300 mg q2w versus Placebo|A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measures were reported and continued when previous outcome measure was statistically significant at two-sided 0.05.||1.30|-0.22|0.1658
72495036|NCT04202679|144519222|SUPERIORITY||LS mean difference|-0.61||||0.037|TWO_SIDED|95.0|-1.18|-0.04||Threshold of significance was \<0.05.|ANCOVA||Dupilumab 300 mg q2w versus Placebo|||-0.04|-1.18|0.0370
72437321|NCT02716324|144388124|SUPERIORITY|||||||0.915|||||||Chi-squared|||Differences in proportions between the two groups in use of any inpatient mental health services were assessed using the Chi-square Test.||||0.915
72437322|NCT02716324|144388125|SUPERIORITY|||||||0.31|||||||Chi-squared|||Differences in proportions between the two groups in use of any mental health services during the study period were assessed using the Chi-square Test.||||0.310
72437323|NCT02716324|144388125|SUPERIORITY|||||||0.251|||||||Chi-squared|||Differences in proportions between the two groups in use of ambulatory mental health services during the study period were assessed using the Chi-square Test.||||0.251
72495037|NCT02066792|144519236|SUPERIORITY||Mean Difference (Final Values)|-0.51|STANDARD_ERROR_OF_MEAN|0.15|<|0.001|TWO_SIDED|95.0|-0.81|-0.21||two-sided|Mixed Models Analysis|Four level multivariate MLM with measures nested within time, which was nested within subjects, who were nested within treatment cohort.||At 3 month follow-up||-.21|-.81|<.001
72495038|NCT02066792|144519236|SUPERIORITY||Mean Difference (Final Values)|-0.07|STANDARD_ERROR_OF_MEAN|0.15||0.635|TWO_SIDED|95.0|-0.37|0.23||Two-sided|Mixed Models Analysis|Four level multivariate MLM with measures nested within time, which was nested within subjects, who were nested within treatment cohort.||3 month follow-up||.23|-.37|.635
72437324|NCT02716324|144388125|SUPERIORITY|||||||1|||||||Chi-squared|||Differences in proportions between the two groups in use of inpatient mental health services during the study period were assessed using the Chi-square Test.||||1.00
72495039|NCT02066792|144519236|SUPERIORITY||Mean Difference (Final Values)|-0.49|STANDARD_ERROR_OF_MEAN|0.16||0.002|TWO_SIDED|95.0|-0.8|-0.18|||Mixed Models Analysis|Four level multivariate MLM with measures nested within time, which was nested within subjects, who were nested within treatment cohort.||||-.18|-.80|.002
72384933|NCT00676338|144277592|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-1.39|STANDARD_ERROR_OF_MEAN|1.09||0.201|TWO_SIDED|95.0|-3.52|0.74||No multiple adjustment were done.|Mixed Models Analysis|||Change in Systolic Blood Pressure from baseline to Week 26 was analyzed using an MMRM ANCOVA model with treatment, baseline systolic blood pressure, country, week of visit, and treatment-by week interaction as fixed effects; and patient and error as random effects.||0.74|-3.52|0.201
72384934|NCT00676338|144277592|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.49|STANDARD_ERROR_OF_MEAN|1.24||0.693|TWO_SIDED|95.0|-1.94|2.93||No multiple adjustment were done.|Mixed Models Analysis|||Change in Systolic Blood Pressure from baseline to Week 26 was analyzed using an MMRM ANCOVA model with treatment, baseline systolic blood pressure, country, week of visit, and treatment-by week interaction as fixed effects; and patient and error as random effects.||2.93|-1.94|0.693
72384935|NCT00676338|144277592|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.56|STANDARD_ERROR_OF_MEAN|1.22||0.646|TWO_SIDED|95.0|-1.84|2.96||No multiple adjustment were done.|Mixed Models Analysis|||Change in Systolic Blood Pressure from baseline to Week 26 was analyzed using an MMRM ANCOVA model with treatment, baseline systolic blood pressure, country, week of visit, and treatment-by week interaction as fixed effects; and patient and error as random effects.||2.96|-1.84|0.646
72384936|NCT00676338|144277593|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.36|STANDARD_ERROR_OF_MEAN|0.7||0.61|TWO_SIDED|95.0|-1.02|1.73||No multiple adjustment were done.|Mixed Models Analysis|||Change in Diastolic Blood Pressure from baseline to Week 26 was analyzed using an MMRM ANCOVA model with treatment, baseline diastolic blood pressure, country, week of visit, and treatment-by week interaction as fixed effects; and patient and error as random effects.||1.73|-1.02|0.610
72384937|NCT00676338|144277593|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|2.0|STANDARD_ERROR_OF_MEAN|0.8||0.013|TWO_SIDED|95.0|0.43|3.58||No multiple adjustment were done.|Mixed Models Analysis|||Change in Diastolic Blood Pressure from baseline to Week 26 was analyzed using an MMRM ANCOVA model with treatment, baseline diastolic blood pressure, country, week of visit, and treatment-by week interaction as fixed effects; and patient and error as random effects.||3.58|0.43|0.013
72384938|NCT00676338|144277593|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.79||0.946|TWO_SIDED|95.0|-1.6|1.49||No multiple adjustment were done.|Mixed Models Analysis|||Change in Diastolic Blood Pressure from baseline to Week 26 was analyzed using an MMRM ANCOVA model with treatment, baseline diastolic blood pressure, country, week of visit, and treatment-by week interaction as fixed effects; and patient and error as random effects.||1.49|-1.60|0.946
72384939|NCT02122458|144277594|SUPERIORITY||Mean Difference (Net)|0.448||||0.05|TWO_SIDED|95.0|-8.66|9.56||Given the preliminary nature of this treatment study and the small number of participants the p-value was not adjusted for multiple comparisons.|Mixed Models Analysis|An Adjusted Rank Transform was applied to the data prior to applying the mixed model analyses.||The null hypothesis evaluated by the HHIA was that self-perceived hearing handicap would not reduce from baseline to 6-months post-fitting.||9.56|-8.66|.05
72384940|NCT02122458|144277595|SUPERIORITY|||||||0.05||||||Given the small sample size and the preliminary nature of this study, the p-value was not adjusted for multiple comparisons.|ANOVA|||||||.05
72437325|NCT02716324|144388126|SUPERIORITY||Beta coefficient|0.0||||0.662|TWO_SIDED|95.0|-0.001|0.001|||Random effects model|||Random effects models regressed Parent-reported PRO School Performance Scores on intervention status, time (days), intervention by time, season, and clustered by doctor's office. we examined intervention X time interaction term for statistical significance.||0.001|-0.001|0.662
72437326|NCT02716324|144388126|SUPERIORITY||Beta coefficient|0.001||||0.075|TWO_SIDED|95.0|0.0|0.002|||Random effects model|||Random effects models regressed Child PRO School Performance Scores on intervention status, time (days), intervention by time, season, and clustered by doctor's office. we examined intervention X time interaction term for statistical significance.||0.002|0.000|0.075
72437327|NCT02716324|144388127|SUPERIORITY||Beta coefficient|0.0||||0.707|TWO_SIDED|95.0|-0.001|0.001|||Random effects model|||Random effects models regressed Parent-reported PRO Student Engagement Scores on intervention status, time (days), intervention by time, season, and clustered by doctor's office. we examined intervention X time interaction term for statistical significance.||0.001|-0.001|0.707
72437328|NCT02716324|144388127|SUPERIORITY||Beta coefficient|0.0||||0.735|TWO_SIDED|95.0|-0.001|0.001|||Random effects model|||Random effects models regressed Child PRO Student Engagement Scores on intervention status, time (days), intervention by time, season, and clustered by doctor's office. we examined intervention X time interaction term for statistical significance.||0.001|-0.001|0.735
72437329|NCT02716324|144388128|SUPERIORITY||Beta coefficient|0.0||||0.735|TWO_SIDED|95.0|-0.001|0.001||Random effects models regressed Child Patient Reported Outcomes Teacher Connectedness Scores on intervention status, time (days), intervention by time, season, and clustered by doctor's office. The threshold for statistical significance was p\<0.05.|Random effects model|||Random effects models regressed Child PRO Teacher Connectedness Scores on intervention status, time (days), intervention by time, season, and clustered by doctor's office. we examined intervention X time interaction term for statistical significance.||0.001|-0.001|0.735
72437330|NCT02716324|144388129|SUPERIORITY||Beta coefficient|0.0||||0.873|TWO_SIDED|95.0|-0.001|0.001||Random effects models regressed Parent Patient Reported Outcomes Peer Relationships Scores on intervention status, time (days), intervention by time, season, and clustered by doctor's office. The threshold for statistical significance was p\<0.05.|Random effects model|||Random effects models regressed Parent-reported PRO Peer Relationship Scores on intervention status, time (days), intervention by time, season, and clustered by doctor's office. we examined intervention X time interaction term for statistical significance.||0.001|-0.001|0.873
72384941|NCT03161093|144277599|SUPERIORITY||Least Squares Mean|-0.68|STANDARD_ERROR_OF_MEAN|0.18||0.0002|TWO_SIDED|95.0|-1.028|-0.324|||Mixed Models Analysis|||||-0.324|-1.028|0.0002
72384942|NCT03161093|144277600|SUPERIORITY||Least Squares Mean|-0.7|STANDARD_ERROR_OF_MEAN|0.178|<|0.0001|TWO_SIDED|95.0|-1.046|-0.346|||Mixed Models Analysis|||||-0.346|-1.046|<0.0001
72384943|NCT03161093|144277601|SUPERIORITY||Least Squares Mean|-0.1|STANDARD_ERROR_OF_MEAN|0.254||0.7036|TWO_SIDED|95.0|-0.594|0.401|||Mixed Models Analysis|||||0.401|-0.594|0.7036
72384944|NCT03161093|144277602|SUPERIORITY||Least Squares Mean|-0.18|STANDARD_ERROR_OF_MEAN|0.243||0.4605|TWO_SIDED|95.0|-0.657|0.297|||Mixed Models Analysis|||||0.297|-0.657|0.4605
72384945|NCT02124161|144277648|NON_INFERIORITY_OR_EQUIVALENCE|The criterion for noninferiority was the lower bound of the 2-sided 95% CI for the GMT ratio was greater than 0.5 (2-fold criterion).|GMT Ratio|0.9|||||TWO_SIDED|95.0|0.74|1.12||||||Serotype 1: Confidence Intervals (CIs) for the ratio were back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC+QIV/placebo - placebo+QIV/13vPnC).||1.12|0.74|
72384946|NCT02124161|144277648|NON_INFERIORITY_OR_EQUIVALENCE|The criterion for noninferiority was the lower bound of the 2-sided 95% CI for the GMT ratio was greater than 0.5 (2-fold criterion).|GMT Ratio|0.8|||||TWO_SIDED|95.0|0.7|0.98||||||Serotype 3: Confidence Intervals (CIs) for the ratio were back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC+QIV/placebo - placebo+QIV/13vPnC).||0.98|0.70|
72384947|NCT02124161|144277648|NON_INFERIORITY_OR_EQUIVALENCE|The criterion for noninferiority was the lower bound of the 2-sided 95% CI for the GMT ratio was greater than 0.5 (2-fold criterion).|GMT Ratio|0.7|||||TWO_SIDED|95.0|0.55|0.91||||||Serotype 4: Confidence Intervals (CIs) for the ratio were back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC+QIV/placebo - placebo+QIV/13vPnC).||0.91|0.55|
72384948|NCT02124161|144277648|NON_INFERIORITY_OR_EQUIVALENCE|The criterion for noninferiority was the lower bound of the 2-sided 95% CI for the GMT ratio was greater than 0.5 (2-fold criterion).|GMT Ratio|1.0|||||TWO_SIDED|95.0|0.78|1.18||||||Serotype 5: Confidence Intervals (CIs) for the ratio were back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC+QIV/placebo - placebo+QIV/13vPnC).||1.18|0.78|
72384949|NCT02124161|144277648|NON_INFERIORITY_OR_EQUIVALENCE|The criterion for noninferiority was the lower bound of the 2-sided 95% CI for the GMT ratio was greater than 0.5 (2-fold criterion).|GMT Ratio|0.7|||||TWO_SIDED|95.0|0.53|0.85||||||Serotype 6A: Confidence Intervals (CIs) for the ratio were back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC+QIV/placebo - placebo+QIV/13vPnC).||0.85|0.53|
72384950|NCT02124161|144277648|NON_INFERIORITY_OR_EQUIVALENCE|The criterion for noninferiority was the lower bound of the 2-sided 95% CI for the GMT ratio was greater than 0.5 (2-fold criterion).|GMT Ratio|0.8|||||TWO_SIDED|95.0|0.64|1.08||||||Serotype 6B: Confidence Intervals (CIs) for the ratio were back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC+QIV/placebo - placebo+QIV/13vPnC).||1.08|0.64|
72384951|NCT02124161|144277648|NON_INFERIORITY_OR_EQUIVALENCE|The criterion for noninferiority was the lower bound of the 2-sided 95% CI for the GMT ratio was greater than 0.5 (2-fold criterion).|GMT Ratio|1.0|||||TWO_SIDED|95.0|0.83|1.14||||||Serotype 7F: Confidence Intervals (CIs) for the ratio were back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC+QIV/placebo - placebo+QIV/13vPnC).||1.14|0.83|
72384952|NCT02124161|144277648|NON_INFERIORITY_OR_EQUIVALENCE|The criterion for noninferiority was the lower bound of the 2-sided 95% CI for the GMT ratio was greater than 0.5 (2-fold criterion).|GMT Ratio|0.8|||||TWO_SIDED|95.0|0.69|1.0||||||Serotype 9V: Confidence Intervals (CIs) for the ratio were back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC+QIV/placebo - placebo+QIV/13vPnC).||1.0|0.69|
72384953|NCT02124161|144277648|NON_INFERIORITY_OR_EQUIVALENCE|The criterion for noninferiority was the lower bound of the 2-sided 95% CI for the GMT ratio was greater than 0.5 (2-fold criterion).|GMT Ratio|0.8|||||TWO_SIDED|95.0|0.62|0.92||||||Serotype 14: Confidence Intervals (CIs) for the ratio were back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC+QIV/placebo - placebo+QIV/13vPnC).||0.92|0.62|
72437331|NCT02716324|144388129|SUPERIORITY||Beta coefficient|0.0||||0.888|TWO_SIDED|95.0|-0.001|0.001||Random effects models regressed Child Patient Reported Outcomes Peer Relationships Scores on intervention status, time (days), intervention by time, season, and clustered by doctor's office. The threshold for statistical significance was p\<0.05.|Random effects model|||Random effects models regressed Child-reported PRO Peer Relationship Scores on intervention status, time (days), intervention by time, season, and clustered by doctor's office. we examined intervention X time interaction term for statistical significance.||0.001|-0.001|0.888
72437332|NCT02716324|144388130|SUPERIORITY||Beta coefficient|0.0||||0.679|TWO_SIDED|95.0|-0.001|0.001||Random effects models regressed Child Patient Reported Outcomes Family Relationships Scores on intervention status, time (days), intervention by time, season, and clustered by doctor's office. The threshold for statistical significance was p\<0.05.|Random effects model|||Random effects models regressed Child-reported PRO Family Relationship Scores on intervention status, time (days), intervention by time, season, and clustered by doctor's office. we examined intervention X time interaction term for statistical significance.||0.001|-0.001|0.679
72437333|NCT02716324|144388131|SUPERIORITY||Beta coefficient|0.074||||0.495|TWO_SIDED|95.0|-0.164|0.311|||Random effects model|||Random effects models regressed Access Engagement Scores Scores on intervention status adjusted for season and clustered by doctor's office.||0.311|-0.164|0.495
72437334|NCT02716324|144388131|SUPERIORITY||Beta coefficient|-0.013||||0.885|TWO_SIDED|95.0|-0.217|0.191|||Random effects model|||Random effects models regressed Patient Family Centered Care Engagement Scores Scores on intervention status adjusted for season and clustered by doctor's office.||0.191|-0.217|0.885
72437335|NCT02716324|144388131|SUPERIORITY||Beta coefficient|0.073||||0.527|TWO_SIDED|95.0|-0.182|0.328|||Random effects model|||Random effects models regressed Communication Engagement Scores Scores on intervention status adjusted for season and clustered by doctor's office.||0.328|-0.182|0.527
72384954|NCT02124161|144277648|NON_INFERIORITY_OR_EQUIVALENCE|The criterion for noninferiority was the lower bound of the 2-sided 95% CI for the GMT ratio was greater than 0.5 (2-fold criterion).|GMT Ratio|0.8|||||TWO_SIDED|95.0|0.64|1.06||||||Serotype 18C: Confidence Intervals (CIs) for the ratio were back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC+QIV/placebo - placebo+QIV/13vPnC).||1.06|0.64|
72384955|NCT02124161|144277648|NON_INFERIORITY_OR_EQUIVALENCE|The criterion for noninferiority was the lower bound of the 2-sided 95% CI for the GMT ratio was greater than 0.5 (2-fold criterion).|GMT Ratio|0.9|||||TWO_SIDED|95.0|0.72|1.04||||||Serotype 19A: Confidence Intervals (CIs) for the ratio were back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC+QIV/placebo - placebo+QIV/13vPnC).||1.04|0.72|
72558486|NCT00112437|144646487|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|4.69|||<=|0.001|TWO_SIDED|95.0|3.25|6.12||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on femoral neck BMD compared to placebo over 24 months. The secondary hypothesis states that odanacatib will increase femoral neck BMD compared to placebo over 24 months.||6.12|3.25|<=0.001
72384956|NCT02124161|144277648|NON_INFERIORITY_OR_EQUIVALENCE|The criterion for noninferiority was the lower bound of the 2-sided 95% CI for the GMT ratio was greater than 0.5 (2-fold criterion).|GMT Ratio|0.9|||||TWO_SIDED|95.0|0.71|1.14||||||Serotype 19F: Confidence Intervals (CIs) for the ratio were back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC+QIV/placebo - placebo+QIV/13vPnC).||1.14|0.71|
72384957|NCT02124161|144277648|NON_INFERIORITY_OR_EQUIVALENCE|The criterion for noninferiority was the lower bound of the 2-sided 95% CI for the GMT ratio was greater than 0.5 (2-fold criterion).|GMT Ratio|0.8|||||TWO_SIDED|95.0|0.56|1.03||||||Serotype 23F: Confidence Intervals (CIs) for the ratio were back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC+QIV/placebo - placebo+QIV/13vPnC).||1.03|0.56|
72384958|NCT02124161|144277649|NON_INFERIORITY_OR_EQUIVALENCE|The criterion for noninferiority was the lower bound of the 2-sided 95% CI for the GMT ratio was greater than 0.5 (2-fold criterion).|GMT Ratio|1.0|||||TWO_SIDED|95.0|0.88|1.18||||||Strain A/H1N1: CIs for the ratio were back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC+QIV/placebo - placebo+QIV/13vPnC).||1.18|0.88|
72384959|NCT02124161|144277649|NON_INFERIORITY_OR_EQUIVALENCE|The criterion for noninferiority was the lower bound of the 2-sided 95% CI for the GMT ratio was greater than 0.5 (2-fold criterion).|GMT Ratio|1.2|||||TWO_SIDED|95.0|1.01|1.32||||||Strain A/H3N2: CIs for the ratio were back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC+QIV/placebo - placebo+QIV/13vPnC).||1.32|1.01|
72384960|NCT02124161|144277649|NON_INFERIORITY_OR_EQUIVALENCE|The criterion for noninferiority was the lower bound of the 2-sided 95% CI for the GMT ratio was greater than 0.5 (2-fold criterion).|GMT Ratio|1.1|||||TWO_SIDED|95.0|0.95|1.24||||||Strain B/Brisbane: CIs for the ratio were back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC+QIV/placebo - placebo+QIV/13vPnC).||1.24|0.95|
72384961|NCT02124161|144277649|NON_INFERIORITY_OR_EQUIVALENCE|The criterion for noninferiority was the lower bound of the 2-sided 95% CI for the GMT ratio was greater than 0.5 (2-fold criterion).|GMT Ratio|1.0|||||TWO_SIDED|95.0|0.9|1.21||||||Strain B/Massachusetts: CIs for the ratio were back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC+QIV/placebo - placebo+QIV/13vPnC).||1.21|0.90|
72384962|NCT02124161|144277652|SUPERIORITY_OR_OTHER||Percentage Difference|2.8|||||TWO_SIDED|95.0|-1.9|7.4||||||AE: Exact 2-sided confidence interval (based on Chan and Zhang) for the difference in proportions, 13vPnC+QIV /placebo - placebo+QIV/13vPnC, expressed as a percentage.||7.4|-1.9|
72384963|NCT02124161|144277652|SUPERIORITY_OR_OTHER||Percentage Difference|0.0|||||TWO_SIDED|95.0|-1.8|1.7||||||SAE: Exact 2-sided confidence interval (based on Chan and Zhang) for the difference in proportions, 13vPnC+QIV /placebo - placebo+QIV/13vPnC, expressed as a percentage.||1.7|-1.8|
72384964|NCT02124161|144277654|SUPERIORITY_OR_OTHER||Percentage Difference|-2.8||||0.333|TWO_SIDED|95.0|-8.3|2.8|||Chan and Zhang method|||Serotype 1: Exact 2-sided CI and corresponding p-value (based on Chan and Zhang) for the difference in proportions, (13vPnC+QIV/placebo - placebo+QIV/13vPnC), expressed as a percentage.||2.8|-8.3|0.333
72384965|NCT02124161|144277654|SUPERIORITY_OR_OTHER||Percentage Difference|-4.3||||0.105|TWO_SIDED|95.0|-9.6|0.9|||Chan and Zhang method|||Serotype 3: Exact 2-sided CI and corresponding p-value (based on Chan and Zhang) for the difference in proportions, (13vPnC+QIV/placebo - placebo+QIV/13vPnC), expressed as a percentage.||0.9|-9.6|0.105
72384966|NCT02124161|144277654|SUPERIORITY_OR_OTHER||Percentage Difference|-3.5||||0.09|TWO_SIDED|95.0|-7.6|0.6|||Chan and Zhang method|||Serotype 4: Exact 2-sided CI and corresponding p-value (based on Chan and Zhang) for the difference in proportions, (13vPnC+QIV/placebo - placebo+QIV/13vPnC), expressed as a percentage.||0.6|-7.6|0.090
72384967|NCT02124161|144277654|SUPERIORITY_OR_OTHER||Percentage Difference|1.8||||0.59|TWO_SIDED|95.0|-4.2|7.8|||Chan and Zhang method|||Serotype 5: Exact 2-sided CI and corresponding p-value (based on Chan and Zhang) for the difference in proportions, (13vPnC+QIV/placebo - placebo+QIV/13vPnC), expressed as a percentage.||7.8|-4.2|0.590
72437336|NCT02716324|144388131|SUPERIORITY||Beta coefficient|0.136||||0.285|TWO_SIDED|95.0|-0.138|0.41|||Random effects model|||Random effects models regressed Understanding Engagement Scores Scores on intervention status adjusted for season and clustered by doctor's office.||0.410|-0.138|0.285
72384968|NCT02124161|144277654|SUPERIORITY_OR_OTHER||Percentage Difference|-3.7||||0.044|TWO_SIDED|95.0|-7.5|-0.1|||Chan and Zhang method|||Serotype 6A: Exact 2-sided CI and corresponding p-value (based on Chan and Zhang) for the difference in proportions, (13vPnC+QIV/placebo - placebo+QIV/13vPnC), expressed as a percentage.||-0.1|-7.5|0.044
72384969|NCT02124161|144277654|SUPERIORITY_OR_OTHER||Percentage Difference|-1.4||||0.574|TWO_SIDED|95.0|-6.2|3.4|||Chan and Zhang method|||Serotype 6B: Exact 2-sided CI and corresponding p-value (based on Chan and Zhang) for the difference in proportions, (13vPnC+QIV/placebo - placebo+QIV/13vPnC), expressed as a percentage.||3.4|-6.2|0.574
72384970|NCT02124161|144277654|SUPERIORITY_OR_OTHER||Percentage Difference|-1.2||||0.648|TWO_SIDED|95.0|-6.3|3.9|||Chan and Zhang method|||Serotype 7F: Exact 2-sided CI and corresponding p-value (based on Chan and Zhang) for the difference in proportions, (13vPnC+QIV/placebo - placebo+QIV/13vPnC), expressed as a percentage.||3.9|-6.3|0.648
72384971|NCT02124161|144277654|SUPERIORITY_OR_OTHER||Percentage Difference|-6.2||||0.057|TWO_SIDED|95.0|-12.5|0.2|||Chan and Zhang method|||Serotype 9V: Exact 2-sided CI and corresponding p-value (based on Chan and Zhang) for the difference in proportions, (13vPnC+QIV/placebo - placebo+QIV/13vPnC), expressed as a percentage.||0.2|-12.5|0.057
72437337|NCT01391130|144388135|SUPERIORITY||Hazard Ratio (HR)|1.2149||||0.4318|TWO_SIDED|95.0|0.7462|1.9779|||Log Rank|||||1.9779|0.7462|0.4318
72437338|NCT00880048|144388144|SUPERIORITY||Mean Difference (Net)|-1.6||||0.0133|TWO_SIDED|95.0|-2.87|-0.34|||Mixed Models Repeated Measures|||Placebo vs GW823296 30mg: Week 1||-0.34|-2.87|0.0133
72437339|NCT00880048|144388144|SUPERIORITY||Mean Difference (Net)|-2.26||||0.0006|TWO_SIDED|95.0|-3.54|-0.98|||Mixed Models Repeated Measures|||Placebo vs GW823296 60mg: Week 1||-0.98|-3.54|0.0006
72437340|NCT00880048|144388144|SUPERIORITY||Mean Difference (Net)|-1.57||||0.0394|TWO_SIDED|95.0|-3.06|-0.08|||Mixed Models Repeated Measures|||Placebo vs GW823296 30 mg: Week 2||-0.08|-3.06|0.0394
72437341|NCT00880048|144388144|SUPERIORITY||Mean Difference (Net)|-1.65||||0.0332|TWO_SIDED|95.0|-3.16|-0.13|||Mixed Models Repeated Measures|||Placebo vs GW823296 60mg: Week 2||-0.13|-3.16|0.0332
72437342|NCT00880048|144388144|SUPERIORITY||Mean Difference (Net)|-1.82||||0.0601|TWO_SIDED|95.0|-3.71|0.08|||Mixed Models Repeated Measures|||Placebo vs GW823296 30mg: Week 4||0.08|-3.71|0.0601
72437343|NCT00880048|144388144|SUPERIORITY||Mean Difference (Net)|-2.03||||0.0369|TWO_SIDED|95.0|-3.94|-0.12|||Mixed Models Repeated Measures|||Placebo vs GW823296 60mg: Week 4||-0.12|-3.94|0.0369
72437344|NCT00880048|144388144|SUPERIORITY||Mean Difference (Net)|-1.67||||0.1122|TWO_SIDED|95.0|-3.73|0.39|||Mixed Models Repeated Measures|||Placebo vs GW823296 30mg: Week 6||0.39|-3.73|0.1122
72437345|NCT00880048|144388144|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.76||||0.4713|TWO_SIDED|95.0|-2.85|1.32|||Mixed Models Repeated Measures|||Placebo vs GW823296 60mg: Week 6||1.32|-2.85|0.4713
72437346|NCT00880048|144388145|SUPERIORITY||Odds Ratio (OR)|2.15||||0.2232|TWO_SIDED|95.0|0.63|7.39|||Regression, Logistic|||Placebo vs GW823296 30mg: Week 1||7.39|0.63|0.2232
72437347|NCT00880048|144388145|SUPERIORITY||Odds Ratio (OR)|3.15||||0.0559|TWO_SIDED|95.0|0.97|10.2|||Regression, Logistic|||Placebo vs GW823296 60mg: Week 1||10.2|0.97|0.0559
72437348|NCT00880048|144388145|SUPERIORITY||Odds Ratio (OR)|1.52||||0.3395|TWO_SIDED|95.0|0.64|3.61|||Regression, Logistic|||Placebo vs GW823296 30mg: Week 2||3.61|0.64|0.3395
72437349|NCT00880048|144388145|SUPERIORITY||Odds Ratio (OR)|1.44||||0.4256|TWO_SIDED|95.0|0.59|3.5|||Regression, Logistic|||Placebo vs GW823296 60mg: Week 2||3.50|0.59|0.4256
72437350|NCT00880048|144388145|SUPERIORITY||Odds Ratio (OR)|1.35||||0.379|TWO_SIDED|95.0|0.69|2.64|||Regression, Logistic|||Placebo vs GW823296 30mg: Week 4||2.64|0.69|0.3790
72437351|NCT00880048|144388145|SUPERIORITY||Odds Ratio (OR)|1.47||||0.2554|TWO_SIDED|95.0|0.76|2.86|||Regression, Logistic|||Placebo vs GW823296 60mg: Week 4||2.86|0.76|0.2554
72437352|NCT00880048|144388145|SUPERIORITY||Odds Ratio (OR)|1.53||||0.1961|TWO_SIDED|95.0|0.8|2.91|||Regression, Logistic|||Placebo vs GW823296 30mg: Week 6||2.91|0.80|0.1961
72437353|NCT00880048|144388145|SUPERIORITY||Odds Ratio (OR)|1.15||||0.6916|TWO_SIDED|95.0|0.58|2.25|||Regression, Logistic|||Placebo vs GW823296 60mg: Week 6||2.25|0.58|0.6916
72495040|NCT02066792|144519236|SUPERIORITY||Mean Difference (Final Values)|-0.44|STANDARD_ERROR_OF_MEAN|0.15||0.004|TWO_SIDED|95.0|-0.73|-0.14|||Mixed Models Analysis|Four level multivariate MLM with measures nested within time, which was nested within subjects, who were nested within treatment cohort.||3 month follow-up||-.14|-.73|.004
72495041|NCT02066792|144519236|SUPERIORITY||Mean Difference (Final Values)|-0.41|STANDARD_ERROR_OF_MEAN|0.16||0.008|TWO_SIDED|95.0|-0.72|-0.11|||Mixed Models Analysis|Four level multivariate MLM with measures nested within time, which was nested within subjects, who were nested within treatment cohort.||3 month follow-up||-.11|-.72|.008
72495042|NCT04669678|144519237|OTHER||Odds Ratio (OR)|0.85||||0.306|TWO_SIDED|90.0|0.65|1.11|||Mixed Models Analysis|||Week 2||1.11|0.65|0.306
72495043|NCT04669678|144519237|OTHER||Odds Ratio (OR)|0.81||||0.874|TWO_SIDED|90.0|0.6|1.09|||Mixed Models Analysis|||Week 4||1.09|0.60|0.874
72495044|NCT04669678|144519237|OTHER||Odds Ratio (OR)|1.04||||0.646|TWO_SIDED|90.0|0.91|1.19|||Mixed Models Analysis|||Week 8||1.19|0.91|0.646
72437354|NCT00880048|144388146|SUPERIORITY||Hazard Ratio (HR)|0.98||||0.61|TWO_SIDED|95.0|0.5|1.95|||Log Rank|||||1.95|0.50|0.61
72437355|NCT00880048|144388146|SUPERIORITY||Hazard Ratio (HR)|0.74||||0.35|TWO_SIDED|95.0|0.36|1.54|||Log Rank|||||1.54|0.36|0.35
72437356|NCT00880048|144388147|SUPERIORITY||Mean Difference (Net)|-0.69||||0.0362|TWO_SIDED|95.0|-1.34|-0.04|||Mixed Models Repeated Measures|||Placebo vs GW823296 30mg: Week 1||-0.04|-1.34|0.0362
72437357|NCT00880048|144388147|SUPERIORITY||Mean Difference (Net)|-0.81||||0.0155|TWO_SIDED|95.0|-1.46|-0.16|||Mixed Models Repeated Measures|||Placebo vs GW823296 60mg: Week 1||-0.16|-1.46|0.0155
72437358|NCT00880048|144388147|SUPERIORITY||Mean Difference (Net)|-0.46||||0.2593|TWO_SIDED|95.0|-1.27|0.34|||Mixed Models Repeated Measures|||Placebo vs GW823296 30mg: Week 2||0.34|-1.27|0.2593
72437359|NCT00880048|144388147|SUPERIORITY||Mean Difference (Net)|-0.62||||0.1407|TWO_SIDED|95.0|-1.44|0.2|||Mixed Models Repeated Measures|||Placebo vs GW823296 60mg: Week 2||0.20|-1.44|0.1407
72437360|NCT00880048|144388147|SUPERIORITY||Mean Difference (Net)|-0.67||||0.1933|TWO_SIDED|95.0|-1.67|0.34|||Mixed Models Repeated Measures|||Placebo vs GW823296 30mg: Week 4||0.34|-1.67|0.1933
72437361|NCT00880048|144388147|SUPERIORITY||Mean Difference (Net)|-0.74||||0.15|TWO_SIDED|95.0|-1.76|0.27|||Mixed Models Repeated Measures|||Placebo vs GW823296 60mg: Week 4||0.27|-1.76|0.1500
72437362|NCT00880048|144388147|SUPERIORITY||Mean Difference (Net)|-1.09||||0.055|TWO_SIDED|95.0|-2.21|0.02|||Mixed Models Repeated Measures|||Placebo vs GW823296 30mg: Week 6||0.02|-2.21|0.0550
72437363|NCT00880048|144388147|SUPERIORITY||Mean Difference (Net)|-0.52||||0.3627|TWO_SIDED|95.0|-1.65|0.61|||Mixed Models Repeated Measures|||Placebo vs GW823296 60mg: Week 6||0.61|-1.65|0.3627
72437364|NCT00880048|144388148|SUPERIORITY||Mean Difference (Net)|-1.03||||0.0616|TWO_SIDED|95.0|-2.11|0.05|||Mixed Models Repeated Measures|||Placebo vs GW823296 30mg: Week 1||0.05|-2.11|0.0616
72495045|NCT04669678|144519237|OTHER||Odds Ratio (OR)|1.02||||0.869|TWO_SIDED|90.0|0.82|1.28|||Mixed Models Analysis|||Week 12||1.28|0.82|0.869
72495046|NCT04669678|144519237|OTHER||Odds Ratio (OR)|0.51||||0.044|TWO_SIDED|90.0|0.3|0.88|||Mixed Models Analysis|||Week 2||0.88|0.30|0.044
72495047|NCT04669678|144519237|OTHER||Odds Ratio (OR)|0.36|||<|0.001|TWO_SIDED|90.0|0.28|0.46|||Mixed Models Analysis|||Week 4||0.46|0.28|<0.001
72495048|NCT04669678|144519237|OTHER||Odds Ratio (OR)|0.37|||<|0.001|TWO_SIDED|90.0|0.27|0.49|||Mixed Models Analysis|||Week 8||0.49|0.27|<0.001
72495049|NCT04669678|144519237|OTHER||Odds Ratio (OR)|0.44|||<|0.001|TWO_SIDED|90.0|0.35|0.54|||Mixed Models Analysis|||Week 12||0.54|0.35|<0.001
72495050|NCT04669678|144519238|OTHER||Odds Ratio (OR)|1.25||||0.641|TWO_SIDED|90.0|0.57|2.74|||Mixed Models Analysis|||Week 2||2.74|0.57|0.641
72495051|NCT04669678|144519238|OTHER||Odds Ratio (OR)|1.57||||0.204|TWO_SIDED|90.0|0.87|2.8|||Mixed Models Analysis|||Week 4||2.80|0.87|0.204
72558487|NCT00112437|144646487|SUPERIORITY_OR_OTHER||Difference in Least Square Means|3.57|||<=|0.001|TWO_SIDED|95.0|2.18|4.97||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on femoral neck BMD compared to placebo over 24 months. The secondary hypothesis states that odanacatib will increase femoral neck BMD compared to placebo over 24 months.||4.97|2.18|<=0.001
72558488|NCT00112437|144646487|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|2.82|||<=|0.001|TWO_SIDED|95.0|1.39|4.25||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on femoral neck BMD compared to placebo over 24 months. The secondary hypothesis states that odanacatib will increase femoral neck BMD compared to placebo over 24 months.||4.25|1.39|<=0.001
72558489|NCT00112437|144646487|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-0.41||||0.585|TWO_SIDED|95.0|-1.85|1.04||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on femoral neck BMD compared to placebo over 24 months. The secondary hypothesis states that odanacatib will increase femoral neck BMD compared to placebo over 24 months.||1.04|-1.85|0.585
72618786|NCT01026038|144768112|SUPERIORITY_OR_OTHER||Percent Difference|-3.6|||||TWO_SIDED|95.0|-12.5|3.2||||||Serotype 5: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 7vPnC/7vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/13vPnC/13vPnC along with exact 2-sided 95% CI.||3.2|-12.5|
72495052|NCT04669678|144519238|OTHER||Odds Ratio (OR)|1.29||||0.415|TWO_SIDED|90.0|0.77|2.15|||Mixed Models Analysis|||Week 8||2.15|0.77|0.415
72495053|NCT04669678|144519238|OTHER||Odds Ratio (OR)|2.23||||0.027|TWO_SIDED|90.0|1.23|4.06|||Mixed Models Analysis|||Week 12||4.06|1.23|0.027
72495054|NCT04669678|144519238|OTHER||Odds Ratio (OR)|1.86||||0.274|TWO_SIDED|90.0|0.73|4.73|||Mixed Models Analysis|||Week 2||4.73|0.73|0.274
72495055|NCT04669678|144519238|OTHER||Odds Ratio (OR)|1.83||||0.065|TWO_SIDED|90.0|1.07|3.13|||Mixed Models Analysis|||Week 4||3.13|1.07|0.065
72495056|NCT04669678|144519238|OTHER||Odds Ratio (OR)|1.72||||0.252|TWO_SIDED|90.0|0.79|3.75|||Mixed Models Analysis|||Week 8||3.75|0.79|0.252
72495057|NCT04669678|144519238|OTHER||Odds Ratio (OR)|2.61||||0.002|TWO_SIDED|90.0|1.57|4.33|||Mixed Models Analysis|||Week 12||4.33|1.57|0.002
72495058|NCT04669678|144519238|OTHER||Odds Ratio (OR)|0.78||||0.46|TWO_SIDED|90.0|0.46|1.34|||Mixed Models Analysis|||Week 20||1.34|0.46|0.460
72495059|NCT04669678|144519238|OTHER||Odds Ratio (OR)|1.59||||0.019|TWO_SIDED|90.0|1.15|2.2|||Mixed Models Analysis|||Week 24||2.20|1.15|0.019
72495060|NCT04669678|144519238|OTHER||Odds Ratio (OR)|2.16||||0.061|TWO_SIDED|90.0|1.1|4.27|||Mixed Models Analysis|||Week 2||4.27|1.10|0.061
72495061|NCT04669678|144519238|OTHER||Odds Ratio (OR)|1.64||||0.106|TWO_SIDED|90.0|0.99|2.71|||Mixed Models Analysis|||Week 4||2.71|0.99|0.106
72495062|NCT04669678|144519238|OTHER||Odds Ratio (OR)|1.77||||0.144|TWO_SIDED|90.0|0.93|3.36|||Mixed Models Analysis|||Week 8||3.36|0.93|0.144
72495063|NCT04669678|144519238|OTHER||Odds Ratio (OR)|2.37||||0.011|TWO_SIDED|90.0|1.36|4.16|||Mixed Models Analysis|||Week 12||4.16|1.36|0.011
72495064|NCT05227690|144519240|SUPERIORITY|Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.|LS Mean Difference|-3.0|STANDARD_ERROR_OF_MEAN|2.24|=|0.1765|TWO_SIDED|95.0|-7.5|1.4|||Mixed Model for Repeated Measures (MMRM)||Emraclidine 30 mg - Placebo|Emraclidine 30 mg versus Placebo||1.4|-7.5|=0.1765
72495065|NCT05227690|144519240|SUPERIORITY|Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.|LS Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|2.26|=|0.6007|TWO_SIDED|95.0|-5.6|3.3|||Mixed Model for Repeated Measures (MMRM)||Emraclidine 10 mg - Placebo|Emraclidine 10 mg versus Placebo||3.3|-5.6|=0.6007
72495066|NCT05227690|144519241|SUPERIORITY|Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.|LS Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.124|=|0.2534|TWO_SIDED|95.0|-0.39|0.1|||Mixed Model for Repeated Measures (MMRM)||Emraclidine 30 mg - Placebo|Emraclidine 30 mg versus Placebo||0.10|-0.39|=0.2534
72618787|NCT01026038|144768112|SUPERIORITY_OR_OTHER||Percent Difference|0.0|||||TWO_SIDED|95.0|-3.6|6.5||||||Serotype 6A: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 13vPnC/13vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/7vPnC/13vPnC along with exact 2-sided 95% CI.||6.5|-3.6|
72618788|NCT01026038|144768112|SUPERIORITY_OR_OTHER||Percent Difference|0.0|||||TWO_SIDED|95.0|-3.6|6.5||||||Serotype 6A: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 13vPnC/13vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/13vPnC/13vPnC along with exact 2-sided 95% CI.||6.5|-3.6|
72384972|NCT02124161|144277654|SUPERIORITY_OR_OTHER||Percentage Difference|-3.7||||0.03|TWO_SIDED|95.0|-7.3|-0.3|||Chan and Zhang method|||Serotype 14: Exact 2-sided CI and corresponding p-value (based on Chan and Zhang) for the difference in proportions, (13vPnC+QIV/placebo - placebo+QIV/13vPnC), expressed as a percentage.||-0.3|-7.3|0.030
72384973|NCT02124161|144277654|SUPERIORITY_OR_OTHER||Percentage Difference|-2.5||||0.233|TWO_SIDED|95.0|-6.6|1.6|||Chan and Zhang method|||Serotype 18C: Exact 2-sided CI and corresponding p-value (based on Chan and Zhang) for the difference in proportions, (13vPnC+QIV/placebo - placebo+QIV/13vPnC), expressed as a percentage.||1.6|-6.6|0.233
72384974|NCT02124161|144277654|SUPERIORITY_OR_OTHER||Percentage Difference|-1.8||||0.152|TWO_SIDED|95.0|-4.5|0.7|||Chan and Zhang method|||Serotype 19A: Exact 2-sided CI and corresponding p-value (based on Chan and Zhang) for the difference in proportions, (13vPnC+QIV/placebo - placebo+QIV/13vPnC), expressed as a percentage.||0.7|-4.5|0.152
72384975|NCT02124161|144277654|SUPERIORITY_OR_OTHER||Percentage Difference|0.3||||0.926|TWO_SIDED|95.0|-5.1|5.8|||Chan and Zhang method|||Serotype 19F: Exact 2-sided CI and corresponding p-value (based on Chan and Zhang) for the difference in proportions, (13vPnC+QIV/placebo - placebo+QIV/13vPnC), expressed as a percentage.||5.8|-5.1|0.926
72384976|NCT02124161|144277654|SUPERIORITY_OR_OTHER||Percentage Difference|-3.9||||0.143|TWO_SIDED|95.0|-9.1|1.3|||Chan and Zhang method|||Serotype 23F: Exact 2-sided CI and corresponding p-value (based on Chan and Zhang) for the difference in proportions, (13vPnC+QIV/placebo - placebo+QIV/13vPnC), expressed as a percentage.||1.3|-9.1|0.143
72384977|NCT02124161|144277657|NON_INFERIORITY_OR_EQUIVALENCE|The criterion for noninferiority was the lower bound of the 2-sided 95% CI for the GMT ratio was greater than 0.5 (2-fold criterion).|Percentage Difference|5.1||||0.094|TWO_SIDED|95.0|-0.9|11.0|||Chan and Zhang method|||Strain A/H1N1: Exact 2-sided CI and corresponding p-value (based on Chan and Zhang) for the difference in proportions, (13vPnC+QIV/placebo - placebo+QIV/13vPnC), expressed as a percentage.||11.0|-0.9|0.094
72384978|NCT02124161|144277657|NON_INFERIORITY_OR_EQUIVALENCE|The criterion for noninferiority was the lower bound of the 2-sided 95% CI for the GMT ratio was greater than 0.5 (2-fold criterion).|Percentage Difference|-3.8||||0.232|TWO_SIDED|95.0|-9.9|2.4|||Chan and Zhang method|||Strain A/H3N2: Exact 2-sided CI and corresponding p-value (based on Chan and Zhang) for the difference in proportions, (13vPnC+QIV/placebo - placebo+QIV/13vPnC), expressed as a percentage.||2.4|-9.9|0.232
72384979|NCT02124161|144277657|NON_INFERIORITY_OR_EQUIVALENCE|The criterion for noninferiority was the lower bound of the 2-sided 95% CI for the GMT ratio was greater than 0.5 (2-fold criterion).|Percentage Difference|-1.0||||0.734|TWO_SIDED|95.0|-6.6|4.5|||Chan and Zhang method|||Strain B/Brisbane: Exact 2-sided CI and corresponding p-value (based on Chan and Zhang) for the difference in proportions, (13vPnC+QIV/placebo - placebo+QIV/13vPnC), expressed as a percentage.||4.5|-6.6|0.734
72384980|NCT02124161|144277657|NON_INFERIORITY_OR_EQUIVALENCE|The criterion for noninferiority was the lower bound of the 2-sided 95% CI for the GMT ratio was greater than 0.5 (2-fold criterion).|Percentage Difference|-1.5||||0.627|TWO_SIDED|95.0|-7.2|4.3|||Chan and Zhang method|||Strain B/Massachusetts: Exact 2-sided CI and corresponding p-value (based on Chan and Zhang) for the difference in proportions, (13vPnC+QIV/placebo - placebo+QIV/13vPnC), expressed as a percentage.||4.3|-7.2|0.627
72384981|NCT00091442|144277682|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.06||||0.5988||95.0|0.86|1.3||Not adjusted for multiple comparison.|Log Rank|||Null Hypothesis: Designed to detect an improvement in median survival from 15 months to 19.5 months with 80% power.||1.3|0.86|0.5988
72437365|NCT00880048|144388148|SUPERIORITY||Mean Difference (Net)|-2.28|||<|0.0001|TWO_SIDED|95.0|-3.36|-1.19|||Mixed Models Repeated Measures|||Placebo vs GW823296 60mg: Week 1||-1.19|-3.36|<0.0001
72437366|NCT00880048|144388148|SUPERIORITY||Mean Difference (Net)|-1.44||||0.0239|TWO_SIDED|95.0|-2.68|-0.19|||Mixed Models Repeated Measures|||Placebo vs GW823296 30mg: Week 2||-0.19|-2.68|0.0239
72437367|NCT00880048|144388148|SUPERIORITY||Mean Difference (Net)|-1.84||||0.0048|TWO_SIDED|95.0|-3.12|-0.57|||Mixed Models Repeated Measures|||Placebo vs GW823296 60mg: Week 2||-0.57|-3.12|0.0048
72437368|NCT00880048|144388148|SUPERIORITY||Mean Difference (Net)|-1.58||||0.027|TWO_SIDED|95.0|-2.97|-0.18|||Mixed Models Repeated Measures|||Placebo vs GW823296 30mg: Week 4||-0.18|-2.97|0.0270
72437369|NCT00880048|144388148|SUPERIORITY||Mean Difference (Net)|-1.86||||0.0103|TWO_SIDED|95.0|-3.27|-0.44|||Mixed Models Repeated Measures|||Placebo vs GW823296 60mg: Week 4||-0.44|-3.27|0.0103
72384982|NCT00091442|144277683|SUPERIORITY_OR_OTHER|||||||0.0085||95.0||||Not adjusted for multiple comparison|Cochran-Mantel-Haenszel|||Null hypothesis - no difference in response rate between the two treatment groups.||||0.0085
72384983|NCT00091442|144277684|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.65|||<|0.0001||95.0|0.55|0.77|||Log Rank|||"Null hypothersis - no difference in Time to Progression (TTP) between the two treatment groups.~Designed to detect an improvement in median TTP from 6 months to 7.8 months with 80% power, assuming exponential survival distribution."||0.77|0.55|<0.0001
72384984|NCT02758171|144277707|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence acceptable range of 80.00% to 125.00%.|Adjusted geometric mean (gMean) ratio|101.71|STANDARD_DEVIATION|5.8|<|0.0001|TWO_SIDED|90.0|99.818|103.644|||ANOVA||"The ratio \[%\] calculated as T \[FDC (10 mg Empagliflozin and 5 mg Linagliptin)\]/R \[Empagliflozin (10 mg) + Linagliptin (5 mg) Single Tablets\].~Standard deviation is actually intra-individual geometric coefficient of variation (gCV) \[%\]."|The statistical model used was an Analysis of Variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: Sequence, subjects within sequences, period, and treatment. The effect subjects within sequences was considered as random, whereas the other effects were considered as fixed.||103.644|99.818|<0.0001
72437370|NCT00880048|144388148|SUPERIORITY||Mean Difference (Net)|-1.53||||0.0497|TWO_SIDED|95.0|-3.06|0.0|||Mixed Models Repeated Measures|||Placebo vs GW823296 30mg: Week 6||-0.00|-3.06|0.0497
72437371|NCT00880048|144388148|SUPERIORITY||Mean Difference (Net)|-1.41||||0.0794|TWO_SIDED|95.0|-2.98|0.17|||Mixed Models Repeated Measures|||Placebo vs GW823296 60mg: Week 6||0.17|-2.98|0.0794
72437372|NCT00880048|144388149|SUPERIORITY||Mean Difference (Net)|-0.28||||0.24|TWO_SIDED|95.0|-0.75|0.19|||Mixed Models Repeated Measures|||Placebo vs GW823296 30mg: Week 1||0.19|-0.75|0.2400
72437373|NCT00880048|144388149|SUPERIORITY||Mean Difference (Net)|-0.76||||0.002|TWO_SIDED|95.0|-1.23|-0.28|||Mixed Models Repeated Measures|||Placebo vs GW823296 60mg: Week 1||-0.28|-1.23|0.0020
72437374|NCT00880048|144388149|SUPERIORITY||Mean Difference (Net)|-0.15||||0.5605|TWO_SIDED|95.0|-0.67|0.36|||Mixed Models Repeated Measures|||Placebo vs GW823296 30mg: Week 2||0.36|-0.67|0.5605
72495067|NCT05227690|144519241|SUPERIORITY|Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.|LS Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.125|=|0.6774|TWO_SIDED|95.0|-0.3|0.19|||Mixed Model for Repeated Measures (MMRM)||Emraclidine 10 mg - Placebo|Emraclidine 10 mg versus Placebo||0.19|-0.30|=0.6774
72437375|NCT00880048|144388149|SUPERIORITY||Mean Difference (Net)|-0.33||||0.2215|TWO_SIDED|95.0|-0.86|0.2|||Mixed Models Repeated Measures|||Placebo vs GW823296 60mg: Week 2||0.20|-0.86|0.2215
72437376|NCT00880048|144388149|SUPERIORITY||Mean Difference (Net)|-0.35||||0.287|TWO_SIDED|95.0|-1.01|0.3|||Mixed Models Repeated Measures|||Placebo vs GW823296 30mg: Week 4||0.30|-1.01|0.2870
72437377|NCT00880048|144388149|SUPERIORITY||Mean Difference (Net)|-0.67||||0.0465|TWO_SIDED|95.0|-1.33|-0.01|||Mixed Models Repeated Measures|||Placebo vs GW823296 60mg: Week 4||-0.01|-1.33|0.0465
72437378|NCT00880048|144388149|SUPERIORITY||Mean Difference (Net)|-0.32||||0.3399|TWO_SIDED|95.0|-0.99|0.34|||Mixed Models Repeated Measures|||Placebo vs GW823296 30mg: Week 6||0.34|-0.99|0.3399
72437379|NCT00880048|144388149|SUPERIORITY||Mean Difference (Net)|-0.18||||0.5931|TWO_SIDED|95.0|-0.86|0.49|||Mixed Models Repeated Measures|||Placebo vs GW823296 60mg: Week 6||0.49|-0.86|0.5931
72437380|NCT00880048|144388150|SUPERIORITY||Odds Ratio (OR)|2.83||||0.0562|TWO_SIDED|95.0|0.97|8.22|||Regression, Logistic|||Placebo vs GW823296 30mg: Week 1||8.22|0.97|0.0562
72437381|NCT00880048|144388150|SUPERIORITY||Odds Ratio (OR)|2.22||||0.1596|TWO_SIDED|95.0|0.73|6.73|||Regression, Logistic|||Placebo vs GW823296 60mg: Week 1||6.73|0.73|0.1596
72437382|NCT00880048|144388150|SUPERIORITY||Odds Ratio (OR)|2.91||||0.0067|TWO_SIDED|95.0|1.34|6.3|||Regression, Logistic|||Placebo vs GW823296 30mg: Week 2||6.30|1.34|0.0067
72437383|NCT00880048|144388150|SUPERIORITY||Odds Ratio (OR)|1.93||||0.1154|TWO_SIDED|95.0|0.85|4.36|||Regression, Logistic|||Placebo vs GW823296 60mg: Week 2||4.36|0.85|0.1154
72437384|NCT00880048|144388150|SUPERIORITY||Odds Ratio (OR)|1.13||||0.6895|TWO_SIDED|95.0|0.62|2.07|||Regression, Logistic|||Placebo vs GW823296 30mg: Week 4||2.07|0.62|0.6895
72495068|NCT05227690|144519242|SUPERIORITY|Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.|LS Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|1.1|=|0.3596|TWO_SIDED|95.0|-3.2|1.2|||Mixed Model for Repeated Measures (MMRM)||Emraclidine 30 mg - Placebo|Week 1-- Emraclidine 30 mg versus Placebo||1.2|-3.2|=0.3596
72495069|NCT05227690|144519242|SUPERIORITY|Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.|LS Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|1.1|=|0.6053|TWO_SIDED|95.0|-2.7|1.6|||Mixed Model for Repeated Measures (MMRM)||Emraclidine 10 mg - Placebo|Week 1-- Emraclidine 10 mg versus Placebo||1.6|-2.7|=0.6053
72495070|NCT05227690|144519242|SUPERIORITY|Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.|LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|1.54|=|0.8149|TWO_SIDED|95.0|-3.4|2.7|||Mixed Model for Repeated Measures (MMRM)||Emraclidine 30 mg - Placebo|Week 2-- Emraclidine 30 mg versus Placebo||2.7|-3.4|=0.8149
72618789|NCT01026038|144768112|SUPERIORITY_OR_OTHER||Percent Difference|0.0|||||TWO_SIDED|95.0|-6.6|6.6||||||Serotype 6A: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 7vPnC/7vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/13vPnC/13vPnC along with exact 2-sided 95% CI.||6.6|-6.6|
72618790|NCT01026038|144768112|SUPERIORITY_OR_OTHER||Percent Difference|0.0|||||TWO_SIDED|95.0|-3.6|6.4||||||Serotype 7F: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 13vPnC/13vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/7vPnC/13vPnC along with exact 2-sided 95% CI.||6.4|-3.6|
72437385|NCT00880048|144388150|SUPERIORITY||Odds Ratio (OR)|1.32||||0.3654|TWO_SIDED|95.0|0.72|2.41|||Regression, Logistic|||Placebo vs GW823296 60mg: Week 4||2.41|0.72|0.3654
72437386|NCT00880048|144388150|SUPERIORITY||Odds Ratio (OR)|1.44||||0.2408|TWO_SIDED|95.0|0.78|2.65|||Regression, Logistic|||Placebo vs GW823296 30mg: Week 6||2.65|0.78|0.2408
72437387|NCT00880048|144388150|SUPERIORITY||Odds Ratio (OR)|1.39||||0.3066|TWO_SIDED|95.0|0.74|2.6|||Regression, Logistic|||Placebo vs GW823296 60mg: Week 6||2.60|0.74|0.3066
72437388|NCT00880048|144388151|SUPERIORITY||Mean Difference (Net)|-0.15||||0.1472|TWO_SIDED|95.0|-0.36|0.05|||Mixed Models Repeated Measures|||Placebo vs GW823296 30mg: Week 1||0.05|-0.36|0.1472
72437389|NCT00880048|144388151|SUPERIORITY||Mean Difference (Net)|-0.27||||0.0107|TWO_SIDED|95.0|-0.48|-0.06|||Mixed Models Repeated Measures|||Placebo vs GW823296 60mg: Week 1||-0.06|-0.48|0.0107
72437390|NCT00880048|144388151|SUPERIORITY||Mean Difference (Net)|-0.25||||0.0603|TWO_SIDED|95.0|-0.51|0.01|||Mixed Models Repeated Measures|||Placebo vs GW823296 30mg: Week 2||0.01|-0.51|0.0603
72437391|NCT00880048|144388151|SUPERIORITY||Mean Difference (Net)|-0.2||||0.1458|TWO_SIDED|95.0|-0.46|0.07|||Mixed Models Repeated Measures|||Placebo vs GW823296 60mg: Week 2||0.07|-0.46|0.1458
72437392|NCT00880048|144388151|SUPERIORITY||Mean Difference (Net)|-0.27||||0.0941|TWO_SIDED|95.0|-0.58|0.05|||Mixed Models Repeated Measures|||Placebo vs GW823296 30mg: Week 4||0.05|-0.58|0.0941
72437393|NCT00880048|144388151|SUPERIORITY||Mean Difference (Net)|-0.27||||0.088|TWO_SIDED|95.0|-0.59|0.04|||Mixed Models Repeated Measures||Placebo vs GW823296 60mg: Week 4|||0.04|-0.59|0.0880
72437394|NCT00880048|144388151|SUPERIORITY||Mean Difference (Net)|-0.38||||0.0313|TWO_SIDED|95.0|-0.73|-0.03|||Mixed Models Repeated Measures|||Placebo vs GW823296 30mg: Week 6||-0.03|-0.73|0.0313
72437395|NCT00880048|144388151|SUPERIORITY||Mean Difference (Net)|-0.2||||0.2639|TWO_SIDED|95.0|-0.55|0.15|||Mixed Models Repeated Measures|||Placebo vs GW823296 60mg: Week 6||0.15|-0.55|0.2639
72437396|NCT00880048|144388152|SUPERIORITY||Mean Difference (Net)|-1.57||||0.0421|TWO_SIDED|95.0|-3.08|-0.06|||Mixed Models Repeated Measures|||Placebo vs GW823296 30 mg: Week 1||-0.06|-3.08|0.0421
72618791|NCT01026038|144768112|SUPERIORITY_OR_OTHER||Percent Difference|0.0|||||TWO_SIDED|95.0|-3.5|6.6||||||Serotype 7F: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 13vPnC/13vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/13vPnC/13vPnC along with exact 2-sided 95% CI.||6.6|-3.5|
72384985|NCT02758171|144277708|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence acceptable range of 80.00% to 125.00%.|Adjusted geometric mean (gMean) ratio|99.39|STANDARD_DEVIATION|13.1|<|0.0001|TWO_SIDED|90.0|95.29|103.672|||ANOVA||"The ratio \[%\] calculated as T \[FDC (10 mg Empagliflozin and 5 mg Linagliptin)\]/R \[Empagliflozin (10 mg) + Linagliptin (5 mg) Single Tablets\].~Standard deviation is actually intra-individual geometric coefficient of variation (gCV) \[%\]."|The statistical model used was an Analysis of Variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: Sequence, subjects within sequences, period, and treatment. The effect subjects within sequences was considered as random, whereas the other effects were considered as fixed.||103.672|95.290|<0.0001
72384986|NCT02758171|144277709|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence acceptable range of 80.00% to 125.00%.|Adjusted geometric mean (gMean) ratio|102.33|STANDARD_DEVIATION|13.6|<|0.0001|TWO_SIDED|90.0|97.945|106.91|||ANOVA||"The ratio \[%\] calculated as T \[FDC (10 mg Empagliflozin and 5 mg Linagliptin)\]/R \[Empagliflozin (10 mg) + Linagliptin (5 mg) Single Tablets\].~Standard deviation is actually intra-individual geometric coefficient of variation (gCV) \[%\]."|The statistical model used was an Analysis of Variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: Sequence, subjects within sequences, period, and treatment. The effect subjects within sequences was considered as random, whereas the other effects were considered as fixed.||106.910|97.945|<0.0001
72437397|NCT00880048|144388152|SUPERIORITY||Mean Difference (Net)|-0.74||||0.3394|TWO_SIDED|95.0|-2.27|0.78|||Mixed Models Repeated Measures|||Placebo vs GW823296 60 mg: Week 1||0.78|-2.27|0.3394
72384987|NCT02758171|144277710|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence acceptable range of 80.00% to 125.00%.|Adjusted geometric mean (gMean) ratio|107.51|STANDARD_DEVIATION|27.4||0.0027|TWO_SIDED|90.0|98.561|117.282|||ANOVA||"The ratio \[%\] calculated as T \[FDC (10 mg Empagliflozin and 5 mg Linagliptin)\]/R \[Empagliflozin (10 mg) + Linagliptin (5 mg) Single Tablets\].~Standard deviation is actually intra-individual geometric coefficient of variation (gCV) \[%\]."|The statistical model used was an Analysis of Variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: Sequence, subjects within sequences, period, and treatment. The effect subjects within sequences was considered as random, whereas the other effects were considered as fixed.||117.282|98.561|0.0027
72384988|NCT02758171|144277711|SUPERIORITY_OR_OTHER||Adjusted geometric mean (gMean) ratio|101.44|STANDARD_DEVIATION|5.7|||TWO_SIDED|90.0|99.574|103.336|||ANOVA||"The ratio \[%\] calculated as T \[FDC (10 mg Empagliflozin and 5 mg Linagliptin)\]/R \[Empagliflozin (10 mg) + Linagliptin (5 mg) Single Tablets\].~Standard deviation is actually intra-individual geometric coefficient of variation (gCV) \[%\]."|The statistical model used was an Analysis of Variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: Sequence, subjects within sequences, period, and treatment. The effect subjects within sequences was considered as random, whereas the other effects were considered as fixed.||103.336|99.574|
72384989|NCT02758171|144277712|SUPERIORITY_OR_OTHER||Adjusted geometric mean (gMean) ratio|98.15|STANDARD_DEVIATION|15.2|||TWO_SIDED|90.0|93.456|103.082|||ANOVA||"The ratio \[%\] calculated as T \[FDC (10 mg Empagliflozin and 5 mg Linagliptin)\]/R \[Empagliflozin (10 mg) + Linagliptin (5 mg) Single Tablets\].~Standard deviation is actually intra-individual geometric coefficient of variation (gCV) \[%\]."|The statistical model used was an Analysis of Variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: Sequence, subjects within sequences, period, and treatment. The effect subjects within sequences was considered as random, whereas the other effects were considered as fixed.||103.082|93.456|
72384990|NCT02437383|144277727|SUPERIORITY||LSM Difference (Final Values)|-1.8||||0.414|TWO_SIDED|95.0|-6.2|2.6||P-value is not adjusted for multiple comparisons and the a priori threshold for statistical significance is 0.05.|Mixed Models Analysis|Covariates for site, baseline value, sex, race, treatment, visit, a treatment\*visit interaction, and an unstructured covariance structure.||||2.6|-6.2|0.414
72384991|NCT00464269|144277817|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The overall significance level was controlled at 5 %. The 3 doses of Brivaracetam were tested at the 5 % level against Placebo starting from the 50 mg dose then the 20 mg dose and finally the 5 mg dose, only moving to the next test if the previous one is significant at the 5 % level.|% reduction over Placebo|12.8|||=|0.025|TWO_SIDED|95.0|1.7|22.6|||ANCOVA|Baseline and Treatment Period Partial Onset Seizure (POS) frequencies are standardized to a 7-day duration.|The log-transformed (log(x+1)) POS seizure frequency was analyzed using an ANCOVA model, including terms for treatment, stratification factors, and log-transformed Baseline POS seizure frequency per week as a covariate.|The treatment difference between each Brivaracetam (BRV) dose and Placebo (PBO) is reported as a percent reduction over Placebo. The treatment effect was estimated using the 95 % confidence intervals.||22.6|1.7|=0.025
72437398|NCT00880048|144388152|SUPERIORITY||Mean Difference (Net)|-1.4||||0.0963|TWO_SIDED|95.0|-3.05|0.25|||Mixed Models Repeated Measures|||Placebo vs GW823296 30 mg: Week 2||0.25|-3.05|0.0963
72437399|NCT00880048|144388152|SUPERIORITY||Mean Difference (Net)|-1.94||||0.0235|TWO_SIDED|95.0|-3.62|-0.26|||Mixed Models Repeated Measures|||Placebo vs GW823296 60 mg: Week 2||-0.26|-3.62|0.0235
72437400|NCT00880048|144388152|SUPERIORITY||Mean Difference (Net)|-0.77||||0.3956|TWO_SIDED|95.0|-2.54|1.01|||Mixed Models Repeated Measures|||Placebo vs GW823296 30 mg: Week 4||1.01|-2.54|0.3956
72437401|NCT00880048|144388152|SUPERIORITY||Mean Difference (Net)|-0.73||||0.4273|TWO_SIDED|95.0|-2.53|1.07|||Mixed Models Repeated Measures|||Placebo vs GW823296 60 mg: Week 4||1.07|-2.53|0.4273
72437402|NCT00880048|144388152|SUPERIORITY||Mean Difference (Net)|-0.94||||0.3429|TWO_SIDED|95.0|-2.89|1.01|||Mixed Models Repeated Measures|||Placebo vs GW823296 30 mg: Week 6||1.01|-2.89|0.3429
72437403|NCT00880048|144388152|SUPERIORITY||Mean Difference (Net)|-1.19||||0.2403|TWO_SIDED|95.0|-3.18|0.8|||Mixed Models Repeated Measures|||Placebo vs GW823296 60 mg: Week 6||0.80|-3.18|0.2403
72618792|NCT01026038|144768112|SUPERIORITY_OR_OTHER||Percent Difference|0.0|||||TWO_SIDED|95.0|-6.5|6.7||||||Serotype 7F:Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 7vPnC/7vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/13vPnC/13vPnC along with exact 2-sided 95% CI.||6.7|-6.5|
72384992|NCT00464269|144277817|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The overall significance level was controlled at 5 %. The 3 doses of Brivaracetam were tested at the 5 % level against Placebo starting from the 50 mg dose then the 20 mg dose and finally the 5 mg dose, only moving to the next test if the previous one is significant at the 5 % level.|% reduction over Placebo|4.1|||=|0.492|TWO_SIDED|95.0|-8.1|15.0|||ANCOVA|Baseline and Treatment Period Partial Onset Seizure (POS) frequencies are standardized to 7-day duration.|The log-transformed (log(x+1)) POS seizure frequency was analyzed using an ANCOVA model, including terms for treatment, stratification factors, and log-transformed Baseline POS seizure frequency per week as a covariate.|The treatment difference between each Brivaracetam dose an Placebo is reported as a percent reduction over Placebo. The treatment effect was estimated using 95 % confidence intervals.||15.0|-8.1|=0.492
72384993|NCT01385371|144277846|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.98|||<|0.001||95.0|-1.2|-0.4|||Wilcoxon Rank Sum Test|||||-0.4|-1.2|<0.001
72384994|NCT01385371|144277847|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.64||||0.001|TWO_SIDED|95.0|-0.7|-0.2|||Wilcoxon Rank Sum Test|||||-0.2|-0.7|0.001
72384995|NCT01385371|144277848|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-1.33|||<|0.001|TWO_SIDED|95.0|-1.4|-0.5|||Wilcoxon Rank Sum Test|||||-0.5|-1.4|<0.001
72384996|NCT01385371|144277849|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.13||||0.027||95.0|-0.2|0.0|||Wilcoxon Rank Sum Test|||||0.0|-0.2|0.027
72384997|NCT01385371|144277850|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.48||||0.0003|TWO_SIDED|95.0|-0.73|-0.22||A zero-inflated log-normal mixed distribution model was used with treatment, baseline asthma status, age category (\<18 or \>=18 years) and pollen region as covariates.|Zero-Inflated Log-Normal Model|||||-0.22|-0.73|0.0003
72384998|NCT01385371|144277851|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.69|||<|0.001|TWO_SIDED|95.0|-0.9|-0.2|||Wilcoxon Rank Sum Test|||||-0.2|-0.9|<0.001
72384999|NCT01385371|144277852|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.62||||0.0001|TWO_SIDED|95.0|-0.94|-0.31||A zero-inflated log-normal mixed distribution model was used with treatment, baseline asthma status, age category (\<18 or \>=18 years) and pollen region as covariates.|Zero-Inflated Log-Normal Model|||||-0.31|-0.94|0.0001
72385000|NCT01385371|144277853|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.15||||0.644|TWO_SIDED|95.0|-0.4|0.6|||Wilcoxon Rank Sum Test|||||0.6|-0.4|0.644
72385001|NCT02478372|144277854|SUPERIORITY_OR_OTHER|||||||0.332|TWO_SIDED|||||Significance was set at \<0.01|Chi-squared|||||||0.332
72385002|NCT02955797|144277864|NON_INFERIORITY|95% confidence interval (CI) was stratified on the priming status (meningococcal vaccine naïve or primed monovalent MenC vaccination during infancy) and calculated using the Wald method (normal approximation). Weighted average of the difference over strata was calculated using the Minimal Risk weights with the null variance method. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference between the 2 percentages was greater than (\>) -10%.|Percentage difference|-2.03|||||TWO_SIDED|95.0|-5.84|1.78||||||Serogroup A||1.78|-5.84|
72385003|NCT02955797|144277864|NON_INFERIORITY|95% CI was stratified on the priming status (meningococcal vaccine naïve or primed monovalent MenC vaccination during infancy) and calculated using the Wald method (normal approximation). Weighted average of the difference over strata was calculated using the Minimal Risk weights with the null variance method. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference between the 2 percentages was \> -10%.|Percentage difference|12.1|||||TWO_SIDED|95.0|8.16|16.1||||||Serogroup C||16.1|8.16|
72385004|NCT02955797|144277864|NON_INFERIORITY|95% CI was stratified on the priming status (meningococcal vaccine naïve or primed monovalent MenC vaccination during infancy) and calculated using the Wald method (normal approximation). Weighted average of the difference over strata was calculated using the Minimal Risk weights with the null variance method. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference between the 2 percentages was \> -10%.|Percentage difference|2.42|||||TWO_SIDED|95.0|-1.34|6.19||||||Serogroup Y||6.19|-1.34|
72385005|NCT02955797|144277864|NON_INFERIORITY|95% CI was stratified on the priming status (meningococcal vaccine naïve or primed monovalent MenC vaccination during infancy) and calculated using the Wald method (normal approximation). Weighted average of the difference over strata was calculated using the Minimal Risk weights with the null variance method. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference between the 2 percentages was \> -10%.|Percentage difference|0.458|||||TWO_SIDED|95.0|-4.37|5.28||||||Serogroup W||5.28|-4.37|
72495071|NCT05227690|144519242|SUPERIORITY|Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.|LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|1.55|=|0.9058|TWO_SIDED|95.0|-3.2|2.9|||Mixed Model for Repeated Measures (MMRM)||Emraclidine 10 mg - Placebo|Week 2-- Emraclidine 10 mg versus Placebo||2.9|-3.2|=0.9058
72495072|NCT05227690|144519242|SUPERIORITY|Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.|LS Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|1.71|=|0.5419|TWO_SIDED|95.0|-4.4|2.3|||Mixed Model for Repeated Measures (MMRM)||Emraclidine 30 mg - Placebo|Week 3-- Emraclidine 30 mg versus Placebo||2.3|-4.4|=0.5419
72618793|NCT01026038|144768112|SUPERIORITY_OR_OTHER||Percent Difference|0.0|||||TWO_SIDED|95.0|-3.6|6.7||||||Serotype 19A: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 13vPnC/13vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/7vPnC/13vPnC along with exact 2-sided 95% CI.||6.7|-3.6|
72385006|NCT02955797|144277865|NON_INFERIORITY|95% CI of the difference in percentages was computed using the Wilson Score method without continuity correction. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference between the 2 percentages was \> -10%.|Percentage difference|1.3|||||TWO_SIDED|95.0|-3.6|6.2||||||Serogroup A||6.2|-3.6|
72385007|NCT02955797|144277865|NON_INFERIORITY|95% CI of the difference in percentages was computed using the Wilson Score method without continuity correction. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference between the 2 percentages was \> -10%.|Percentage difference|18.0|||||TWO_SIDED|95.0|13.6|22.8||||||Serogroup C||22.8|13.6|
72558490|NCT00112437|144646488|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|5.09|||<=|0.001|TWO_SIDED|95.0|3.18|7.01||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on trochanter BMD compared to placebo over 24 months. The secondary hypothesis states that odanacatib will increase trochanter BMD compared to placebo over 24 months.||7.01|3.18|<=0.001
72385008|NCT02955797|144277865|NON_INFERIORITY|95% CI of the difference in percentages was computed using the Wilson Score method without continuity correction. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference between the 2 percentages was \> -10%.|Percentage difference|1.6|||||TWO_SIDED|95.0|-2.76|6.03||||||Serogroup Y||6.03|-2.76|
72385009|NCT02955797|144277865|NON_INFERIORITY|95% CI of the difference in percentages was computed using the Wilson Score method without continuity correction. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference between the 2 percentages was \> -10%.|Percentage difference|0.2|||||TWO_SIDED|95.0|-5.85|6.18||||||Serogroup W||6.18|-5.85|
72495073|NCT05227690|144519242|SUPERIORITY|Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.|LS Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|1.72|=|0.8585|TWO_SIDED|95.0|-3.1|3.7|||Mixed Model for Repeated Measures (MMRM)||Emraclidine 10 mg - Placebo|Week 3-- Emraclidine 10 mg versus Placebo||3.7|-3.1|=0.8585
72495074|NCT05227690|144519242|SUPERIORITY|Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.|LS Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|1.99|=|0.5521|TWO_SIDED|95.0|-5.1|2.7|||Mixed Model for Repeated Measures (MMRM)||Emraclidine 30 mg - Placebo|Week 4-- Emraclidine 30 mg versus Placebo||2.7|-5.1|=0.5521
72495075|NCT05227690|144519242|SUPERIORITY|Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.|LS Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|2.0|=|0.754|TWO_SIDED|95.0|-4.6|3.3|||Mixed Model for Repeated Measures (MMRM)||Emraclidine 10 mg - Placebo|Week 4-- Emraclidine 10 mg versus Placebo||3.3|-4.6|=0.7540
72495076|NCT05227690|144519242|SUPERIORITY|Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.|LS Mean Difference|-1.5|STANDARD_ERROR_OF_MEAN|2.12|=|0.4842|TWO_SIDED|95.0|-5.7|2.7|||Mixed Model for Repeated Measures (MMRM)||Emraclidine 30 mg - Placebo|Week 5-- Emraclidine 30 mg versus Placebo||2.7|-5.7|=0.4842
72495077|NCT05227690|144519242|SUPERIORITY|Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.|LS Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|2.13|=|0.6999|TWO_SIDED|95.0|-5.0|3.4|||Mixed Model for Repeated Measures (MMRM)||Emraclidine 10 mg - Placebo|Week 5-- Emraclidine 10 mg versus Placebo||3.4|-5.0|=0.6999
72618794|NCT01026038|144768112|SUPERIORITY_OR_OTHER||Percent Difference|0.0|||||TWO_SIDED|95.0|-3.6|6.6||||||Serotype 19A: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 13vPnC/13vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/13vPnC/13vPnC along with exact 2-sided 95% CI.||6.6|-3.6|
72385010|NCT02955797|144277866|OTHER|95% CI of the ratio of post-vaccination GMTs was stratified on the priming vaccination status (meningococcal vaccine naïve or primed monovalent MenC vaccination) and calculated using an analysis of variance (ANOVA) model of log10-transformed titers.|GMT Ratio|0.819|||||TWO_SIDED|95.0|0.697|0.963||||||Serogroup A||0.963|0.697|
72385011|NCT02955797|144277866|OTHER|95% CI of the ratio of post-vaccination GMTs was stratified on the priming vaccination status (meningococcal vaccine naïve or primed monovalent MenC vaccination) and calculated using an ANOVA model of log10-transformed titers.|GMT Ratio|7.59|||||TWO_SIDED|95.0|6.05|9.52||||||Serogroup C||9.52|6.05|
72385012|NCT02955797|144277866|OTHER|95% CI of the ratio of post-vaccination GMTs was stratified on the priming vaccination status (meningococcal vaccine naïve or primed monovalent MenC vaccination) and calculated using an ANOVA model of log10-transformed titers.|GMT Ratio|1.28|||||TWO_SIDED|95.0|1.09|1.51||||||Serogroup Y||1.51|1.09|
72385013|NCT02955797|144277866|OTHER|95% CI of the ratio of post-vaccination GMTs was stratified on the priming vaccination status (meningococcal vaccine naïve or primed monovalent MenC vaccination) and calculated using an ANOVA model of log10-transformed titers.|GMT Ratio|1.32|||||TWO_SIDED|95.0|1.12|1.56||||||Serogroup W||1.56|1.12|
72385014|NCT02955797|144277867|OTHER||GMT Ratio|1.03|||||TWO_SIDED|95.0|0.85|1.24||||||Serogroup A||1.24|0.85|
72385015|NCT02955797|144277867|OTHER||GMT Ratio|16.5|||||TWO_SIDED|95.0|13.4|20.4||||||Serogroup C||20.4|13.4|
72385016|NCT02955797|144277867|OTHER||GMT Ratio|1.18|||||TWO_SIDED|95.0|0.97|1.44||||||Serogroup Y||1.44|0.97|
72385017|NCT02955797|144277867|OTHER||GMT Ratio|1.34|||||TWO_SIDED|95.0|1.1|1.63||||||Serogroup W||1.63|1.1|
72385018|NCT02955797|144277868|OTHER||GMT Ratio|0.496|||||TWO_SIDED|95.0|0.367|0.672||||||Serogroup A||0.672|0.367|
72385019|NCT02955797|144277868|OTHER||GMT Ratio|1.34|||||TWO_SIDED|95.0|0.814|2.19||||||Serogroup C||2.19|0.814|
72385020|NCT02955797|144277868|OTHER||GMT Ratio|1.53|||||TWO_SIDED|95.0|1.15|2.04||||||Serogroup Y||2.04|1.15|
72385021|NCT02955797|144277868|OTHER||GMT Ratio|1.29|||||TWO_SIDED|95.0|0.944|1.75||||||Serogroup W||1.75|0.944|
72618795|NCT01026038|144768112|SUPERIORITY_OR_OTHER||Percent Difference|0.0|||||TWO_SIDED|95.0|-6.8|6.6||||||Serotype 19A: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 7vPnC/7vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/13vPnC/13vPnC along with exact 2-sided 95% CI.||6.6|-6.8|
72385022|NCT01498978|144277873|OTHER|Exact binomial test (two-sided).||||||0.754|||||||Exact Binomial Test|||Exact binomial test (two-sided). Null hypothesis: the proportion is equal to 0.5||||0.754
72437404|NCT00880048|144388153|SUPERIORITY||Mixed effects repeated measures model|22.52||||0.103|TWO_SIDED|95.0|-4.58|49.61|||Mixed Models Repeated Measures|||Placebo vs GW823296 30 mg: Week 1, total sleep time||49.61|-4.58|0.1030
72385023|NCT01498978|144277874|OTHER|Test of association (contingency) between the two kinds of classification.||||||0.19|||||||Fisher Exact|||||||0.190
72385024|NCT01498978|144277877|OTHER|Test of association (contingency) between the two kinds of classification.||||||0.5|||||||Fisher Exact|||||||0.500
72385025|NCT01498978|144277878|OTHER|Test of association (contingency) between the two kinds of classification.||||||1|||||||Fisher Exact|||||||1.000
72385026|NCT01498978|144277879|OTHER|Test of association (contingency) between the two kinds of classification.||||||0.524|||||||Fisher Exact|||||||0.524
72385027|NCT01033851|144277902|SUPERIORITY_OR_OTHER|||||||0.0366||95.0|||||ANOVA|||A repeated measure ANOVA, with time as the repeated measure, treatment arm as between-subjects factor and CGI-S score as the dependent variable, found a main effect of time (F(1,84)=62.19, p\<0.001) and a significant treatment arm X time interaction (F(1,84)=4.51, p=0.0366).||||0.0366
72385028|NCT01163266|144277909|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.19|STANDARD_ERROR_OF_MEAN|1.151||0.058|TWO_SIDED|95.0|-4.45|0.08||Pre-specified sequential statistical testing procedure indicates that when p-value \>0.025, hierarchical testing stops and for subsequent endpoints in the sequence a nominal p-value is provided.|Mixed model for repeated measurements|MMRM ANCOVA with treatment, center, week, treatment-by-week interaction, baseline MADRS total score-by-week as fixed effects.||All statistical tests were 2-sided with the estimated P-values at the 5% level of significance. To control for multiplicity, a pre-specified sequential testing procedure was applied to compare 10 mg and 20 mg vortioxetine to placebo. Efficacy endpoints were tested for each dose in sequential order at significance level 0.025; as soon as an endpoint was non-significant at 0.025, the testing procedure stopped for all subsequent endpoints.||0.08|-4.45|0.058
72385029|NCT01163266|144277909|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.64|STANDARD_ERROR_OF_MEAN|1.161||0.002|TWO_SIDED|95.0|-5.92|-1.35||Pre-specified sequential statistical testing procedure indicates that when p-value \<0.025, hierarchical testing continues.|Mixed model for repeated measurements|MMRM ANCOVA with treatment, center, week, treatment-by-week interaction, baseline MADRS total score-by-week as fixed effects.||||-1.35|-5.92|0.002
72385030|NCT01163266|144277910|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.29||||0.301|TWO_SIDED|95.0|0.796|2.093|||Regression, Logistic|Logistic regression with explanatory variables for treatment and Baseline MADRS score.||||2.093|0.796|0.301
72385031|NCT01163266|144277910|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.639||||0.044|TWO_SIDED|95.0|1.013|2.652||Pre-specified sequential statistical testing procedure indicates that when p-value \>0.025, hierarchical testing stops and for subsequent endpoints in the sequence a nominal p-value is provided.|Regression, Logistic|Logistic regression with explanatory variables for treatment and Baseline MADRS score.||||2.652|1.013|0.044
72385032|NCT01163266|144277911|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.129||0.119|TWO_SIDED|95.0|-0.45|0.05|||Mixed model for repeated measurements|MMRM ANCOVA with treatment, center, week, treatment-by-week interaction, baseline CGI-S score-by-week as fixed effects.||||0.05|-0.45|0.119
72385033|NCT01163266|144277911|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.29|STANDARD_ERROR_OF_MEAN|0.129||0.024|TWO_SIDED|95.0|-0.55|-0.04|||Mixed model for repeated measurements|MMRM ANCOVA with treatment, center, week, treatment-by-week interaction, baseline CGI-S score-by-week as fixed effects.||||-0.04|-0.55|0.024
72437405|NCT00880048|144388153|SUPERIORITY||Mean Difference (Net)|33.21||||0.0179|TWO_SIDED|95.0|5.76|60.65|||Mixed Models Repeated Measures|||Placebo vs GW823296 60 mg: Week 1, total sleep time||60.65|5.76|0.0179
72437406|NCT00880048|144388153|SUPERIORITY||Mean Difference (Net)|7.62||||0.5773|TWO_SIDED|95.0|-19.25|34.49|||Mixed Models Repeated Measures|||Placebo vs GW823296 30 mg: Week 2, total sleep time||34.49|-19.25|0.5773
72437407|NCT00880048|144388153|SUPERIORITY||Mean Difference (Net)|21.4||||0.125|TWO_SIDED|95.0|-5.97|48.76|||Mixed Models Repeated Measures|||Placebo vs GW823296 60 mg: Week 2, total sleep time||48.76|-5.97|0.1250
72385034|NCT01163266|144277912|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.29|STANDARD_ERROR_OF_MEAN|1.891||0.025|TWO_SIDED|95.0|-8.03|-0.56|||Mixed model for repeated measurements|MMRM ANCOVA with treatment, center, week, treatment-by-week interaction, baseline MADRS Total score-by-week as fixed effects.||||-0.56|-8.03|0.025
72385035|NCT01163266|144277912|SUPERIORITY_OR_OTHER||LS Mean Difference|-7.26|STANDARD_ERROR_OF_MEAN|1.852|<|0.001|TWO_SIDED|95.0|-10.92|-3.6|||Mixed model for repeated measurements|MMRM ANCOVA with treatment, center, week, treatment-by-week interaction, baseline MADRS total score-by-week as fixed effects.||||-3.60|-10.92|<0.001
72385036|NCT01163266|144277913|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.665||||0.093|TWO_SIDED|95.0|0.918|3.018|||Regression, Logistic|Logistic regression with explanatory variables for treatment and Baseline MADRS score.||||3.018|0.918|0.093
72437408|NCT00880048|144388153|SUPERIORITY||Mean Difference (Net)|30.87||||0.0344|TWO_SIDED|95.0|2.29|59.45|||Mixed Models Repeated Measures|||Placebo vs GW823296 30 mg: Week 4, total sleep time||59.45|2.29|0.0344
72618796|NCT01348490|144768124|OTHER|1-sample t-test with null hypothesis mean \>= 0||||||0.025||||||1-sample t-test was used.|t-test, 1 sided|||||||0.0250
72385037|NCT01163266|144277913|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.779||||0.059|TWO_SIDED|95.0|0.979|3.233|||Regression, Logistic|Logistic regression with explanatory variables for treatment and Baseline MADRS score.||||3.233|0.979|0.059
72437409|NCT00880048|144388153|SUPERIORITY||Mean Difference (Net)|36.52||||0.0131|TWO_SIDED|95.0|7.72|65.32|||Mixed Models Repeated Measures|||Placebo vs GW823296 60 mg: Week 4, total sleep time||65.32|7.72|0.0131
72437410|NCT00880048|144388153|SUPERIORITY||Mean Difference (Net)|2.18||||0.8794|TWO_SIDED|95.0|-26.1|30.46|||Mixed Models Repeated Measures|||Placebo vs GW823296 30 mg: Week 6, total sleep time||30.46|-26.10|0.8794
72437411|NCT00880048|144388153|SUPERIORITY||Mean Difference (Net)|28.4||||0.0556|TWO_SIDED|95.0|-0.69|57.5|||Mixed Models Repeated Measures|||Placebo vs GW823296 60 mg: Week 6, total sleep time||57.50|-0.69|0.0556
72618797|NCT01348490|144768124|OTHER|1-sample t-test with null hypothesis mean \>= 0||||||0.0163||||||1-sample t-test was used.|t-test, 1 sided|||||||0.0163
72385038|NCT01163266|144277914|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.39|STANDARD_ERROR_OF_MEAN|1.042||0.183|TWO_SIDED|95.0|-3.44|0.66|||Mixed model for repeated measurements|MMRM ANCOVA with treatment, center, week, treatment-by-week interaction, baseline SDS total score-by-week as fixed effects.||||0.66|-3.44|0.183
72385039|NCT01163266|144277914|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.4|STANDARD_ERROR_OF_MEAN|1.066||0.025|TWO_SIDED|95.0|-4.5|-0.3|||Mixed model for repeated measurements|MMRM ANCOVA with treatment, center, week, treatment-by-week interaction, baseline SDS total score-by-week as fixed effects.||||-0.30|-4.50|0.025
72385040|NCT04308304|144277933|OTHER|MK-1942 + Donepezil PK / MK-1942 Alone PK|Geometric Mean Ratio (GMR)|0.69|||||TWO_SIDED|90.0|0.55|0.86||||||'MK-1942 Alone PK' are unpublished data from MK-1942-004||0.86|0.55|
72385041|NCT04308304|144277933|OTHER|MK-1942 + Donepezil PK / MK-1942 Alone PK|GMR|0.66|||||TWO_SIDED|95.0|0.53|0.82||||||'MK-1942 Alone PK' are unpublished data from MK-1942-004||0.82|0.53|
72385042|NCT04308304|144277933|OTHER|MK-1942 + Donepezil PK / MK-1942 Alone PK|GMR|0.74|||||TWO_SIDED|95.0|0.55|1.0||||||'MK-1942 Alone PK' are unpublished data from MK-1942-004||1.00|0.55|
72385043|NCT04308304|144277933|OTHER|MK-1942 + Donepezil PK / MK-1942 PK Alone|GMR|0.77|||||TWO_SIDED|95.0|0.56|1.05||||||'MK-1942 Alone PK' are unpublished data from MK-1942-004||1.05|0.56|
72385044|NCT04308304|144277934|OTHER|MK-1942 + Donepezil PK / MK-1942 Alone PK|Geometric Mean Ratio (GMR)|0.69|||||TWO_SIDED|90.0|0.55|0.86||||||'MK-1942 Alone PK' are unpublished data from MK-1942-004||0.86|0.55|
72385045|NCT04308304|144277934|OTHER|MK-1942 + Donepezil PK / MK-1942 Alone PK|GMR|0.66|||||TWO_SIDED|95.0|0.53|0.82||||||'MK-1942 Alone PK' are unpublished data from MK-1942-004||0.82|0.53|
72385046|NCT04308304|144277934|OTHER|MK-1942 + Donepezil PK / MK-1942 Alone PK|GMR|0.74|||||TWO_SIDED|95.0|0.55|1.0||||||'MK-1942 Alone PK' are unpublished data from MK-1942-004||1.00|0.55|
72385047|NCT04308304|144277934|OTHER|MK-1942 + Donepezil PK / MK-1942 PK Alone|GMR|0.77|||||TWO_SIDED|95.0|0.56|1.05||||||'MK-1942 Alone PK' are unpublished data from MK-1942-004||1.05|0.56|
72437412|NCT00880048|144388153|SUPERIORITY||Mean Difference (Net)|-23.9||||0.0078|TWO_SIDED|95.0|-41.46|-6.33|||Mixed Models Repeated Measures|||Placebo vs GW823296 30 mg: Week 1, sleep onset latency||-6.33|-41.46|0.0078
72437413|NCT00880048|144388153|SUPERIORITY||Mean Difference (Net)|-25.49||||0.0052|TWO_SIDED|95.0|-43.3|-7.68|||Mixed Models Repeated Measures|||Placebo vs GW823296 60 mg: Week 1, sleep onset latency||-7.68|-43.30|0.0052
72495078|NCT05227690|144519242|SUPERIORITY|Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.|LS Mean Difference|-3.0|STANDARD_ERROR_OF_MEAN|2.24|=|0.1765|TWO_SIDED|95.0|-7.5|1.4|||Mixed Model for Repeated Measures (MMRM)||Emraclidine 30 mg - Placebo|Week 6-- Emraclidine 30 mg versus Placebo||1.4|-7.5|=0.1765
72618798|NCT01348490|144768124|OTHER|1-sample t-test with null hypothesis mean \>= 0|||||<|0.0001||||||1-sample t-test was used.|t-test, 1 sided|||||||<0.0001
72618799|NCT01348490|144768124|OTHER|1-sample t-test with null hypothesis mean \>= 0||||||0.2019||||||1-sample t-test was used.|t-test, 1 sided|||||||0.2019
72618800|NCT01348490|144768125|OTHER|||||||0.6887||||||1-sample t-test was used.|t-test, 1 sided|||||||0.6887
72385048|NCT04308304|144277935|OTHER|MK-1942 + Donepezil PK / MK-1942 Alone PK|Geometric Mean Ratio (GMR)|0.67|||||TWO_SIDED|90.0|0.52|0.87||||||'MK-1942 Alone PK' are unpublished data from MK-1942-004||0.87|0.52|
72385049|NCT04308304|144277935|OTHER|MK-1942 + Donepezil PK / MK-1942 Alone PK|GMR|0.68|||||TWO_SIDED|95.0|0.52|0.87||||||'MK-1942 Alone PK' are unpublished data from MK-1942-004||0.87|0.52|
72385050|NCT04308304|144277935|OTHER|MK-1942 + Donepezil PK / MK-1942 Alone PK|GMR|0.79|||||TWO_SIDED|95.0|0.59|1.06||||||'MK-1942 Alone PK' are unpublished data from MK-1942-004||1.06|0.59|
72385051|NCT04308304|144277935|OTHER|MK-1942 + Donepezil PK / MK-1942 PK Alone|GMR|0.74|||||TWO_SIDED|95.0|0.51|1.08||||||'MK-1942 Alone PK' are unpublished data from MK-1942-004||1.08|0.51|
72385052|NCT04308304|144277936|OTHER|MK-1942 + Donepezil PK / MK-1942 Alone PK|Geometric Mean Ratio (GMR)|0.62|||||TWO_SIDED|90.0|0.48|0.8||||||'MK-1942 Alone PK' are unpublished data from MK-1942-004||0.80|0.48|
72385053|NCT04308304|144277936|OTHER|MK-1942 + Donepezil PK / MK-1942 Alone PK|GMR|0.67|||||TWO_SIDED|95.0|0.55|0.81||||||'MK-1942 Alone PK' are unpublished data from MK-1942-004||0.81|0.55|
72385054|NCT04308304|144277936|OTHER|MK-1942 + Donepezil PK / MK-1942 Alone PK|GMR|0.68|||||TWO_SIDED|95.0|0.49|0.93||||||'MK-1942 Alone PK' are unpublished data from MK-1942-004||0.93|0.49|
72385055|NCT04308304|144277936|OTHER|MK-1942 + Donepezil PK / MK-1942 PK Alone|GMR|0.72|||||TWO_SIDED|95.0|0.54|0.98||||||'MK-1942 Alone PK' are unpublished data from MK-1942-004||0.98|0.54|
72385056|NCT04308304|144277941|OTHER|Donepezil Accumulation Ratio (Day 28/Day -1)|Geometric mean|1.34|STANDARD_ERROR_OF_MEAN|52.4||||||||||||||||
72385057|NCT04308304|144277942|OTHER|Donepezil Accumulation Ratio (Day 28/Day -1)|Geometric mean|1.22|STANDARD_ERROR_OF_MEAN|52.4||||||||||||||||
72385058|NCT04308304|144277943|OTHER|Donepezil Accumulation Ratio (Day 28/Day -1)|Geometric mean|1.46|STANDARD_ERROR_OF_MEAN|60.8||||||||||||||||
72385059|NCT01686828|144277958|SUPERIORITY_OR_OTHER|||||||0.164||||||The a prior threshold for statistical significance was p\<0.05.|RM-ANOVA|||||||0.164
72385060|NCT01686828|144277959|SUPERIORITY_OR_OTHER|||||||0.003|||||||RM-ANOVA|||Time-by-group interaction for fat mass||||0.003
72385061|NCT01686828|144277959|SUPERIORITY_OR_OTHER|||||||0.03||||||Time-by-group interaction for lean mass|RM-ANOVA|||||||0.03
72385062|NCT01686828|144277960|OTHER||||||>|0.1|||||||ANOVA|||The null hypothesis was that short-term testosterone deprivation would not affect lipoprotein lipase expression in adipose tissue. Repeated measures ANOVA was used to determine if a time-by-group effect was apparent for lipoprotein lipase expression.||||>0.1
72437414|NCT00880048|144388153|SUPERIORITY||Mean Difference (Net)|-12.45||||0.2373|TWO_SIDED|95.0|-33.14|8.24|||Mixed Models Repeated Measures|||Placebo vs GW823296 30 mg: Week 2, sleep onset latency||8.24|-33.14|0.2373
72437415|NCT00880048|144388153|SUPERIORITY||Mean Difference (Net)|1.75||||0.8707|TWO_SIDED|95.0|-19.38|22.87|||Mixed Models Repeated Measures|||Placebo vs GW823296 60 mg: Week 2, sleep onset latency||22.87|-19.38|0.8707
72618801|NCT01348490|144768125|OTHER||||||<|0.0001||||||1-sample t-test was used.|t-test, 1 sided|||||||<0.0001
72618802|NCT01348490|144768125|OTHER|||||||0.8701||||||1-sample t-test was used.|t-test, 1 sided|||||||0.8701
72618803|NCT01348490|144768129|OTHER||||||<|0.0001||||||1-sample t-test was used.|t-test, 1 sided|||||||<0.0001
72558491|NCT00112437|144646488|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|4.56|||<=|0.001|TWO_SIDED|95.0|2.7|6.42||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on trochanter BMD compared to placebo over 24 months. The secondary hypothesis states that odanacatib will increase trochanter BMD compared to placebo over 24 months.||6.42|2.70|<=0.001
72558492|NCT00112437|144646488|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|4.43|||<=|0.001|TWO_SIDED|95.0|2.52|6.33||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on trochanter BMD compared to placebo over 24 months. The secondary hypothesis states that odanacatib will increase trochanter BMD compared to placebo over 24 months.||6.33|2.52|<=0.001
72558493|NCT00112437|144646488|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-0.04||||0.981|TWO_SIDED|95.0|-1.97|1.89||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on trochanter BMD compared to placebo over 24 months. The secondary hypothesis states that odanacatib will increase trochanter BMD compared to placebo over 24 months.||1.89|-1.97|0.981
72558494|NCT00112437|144646489|SUPERIORITY_OR_OTHER||Difference in Least square means|1.73|||<=|0.001||95.0|0.46|3.01||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through a stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on Total Body BMD compared to placebo over 24 months. The secondary hypothesis states that odanacatib will increase Total Body BMD compared to placebo over 24 months.||3.01|0.46|<=0.001
72618804|NCT01348490|144768130|OTHER|||||||0.0028||||||1-sample t-test was used.|t-test, 1 sided|||||||0.0028
72385063|NCT02484690|144277981|SUPERIORITY||Difference in Least Squares Means|1.57||||0.5244|TWO_SIDED|80.0|-1.6|4.74||The threshold for statistical significance was an unadjusted 2-sided p-value \<0.2. There was no formal correction for multiple comparisons.|Mixed Model for Repeated Measures|Categorical covariates(cov): RAP/PCV at baseline(BL), treatment group, visit, \& visit by treatment group; Continuous cov: BCVA at BL; Unstructured cov|The mean difference was calculated as Arm B minus Arm A.|The null hypothesis (Ho) was that there was no difference in means between the treatment group (Arm B) and the control group (Arm A). The alternative hypothesis (Ha) was that Arm B mean was different from Arm A mean.||4.74|-1.60|0.5244
72385064|NCT02484690|144277981|SUPERIORITY||Difference in Least Squares Means|-1.59||||0.5308|TWO_SIDED|80.0|-4.86|1.67||The threshold for statistical significance was an unadjusted 2-sided p-value \<0.2. There was no formal correction for multiple comparisons.|Mixed Model for Repeated Measures|Categorical covariates(cov): RAP/PCV at baseline(BL), treatment group, visit, \& visit by treatment group; Continuous cov: BCVA at BL; Unstructured cov|The mean difference was calculated as Arm C minus Arm A.|The null hypothesis (Ho) was that there was no difference in means between the treatment group (Arm C) and the control group (Arm A). The alternative hypothesis (Ha) was that Arm C mean was different from Arm A mean.||1.67|-4.86|0.5308
72618805|NCT03389750|144768142|EQUIVALENCE|An F-test was used to assess for significant differences among the 13 dose conditions.||||||0.0001|||||||ANOVA|F = 7.06 (DF=12)||||||.0001
72385065|NCT02484690|144277981|SUPERIORITY||Difference in Least Squares Means|-1.51||||0.5309|TWO_SIDED|80.0|-4.62|1.59||The threshold for statistical significance was an unadjusted 2-sided p-value \<0.2. There was no formal correction for multiple comparisons.|Mixed Model for Repeated Measures|Categorical covariates(cov): RAP/PCV at baseline(BL), treatment group, visit, \& visit by treatment group; Continuous cov: BCVA at BL; Unstructured cov|The mean difference was calculated as Arm D minus Arm A.|The null hypothesis (Ho) was that there was no difference in means between the treatment group (Arm D) and the control group (Arm A). The alternative hypothesis (Ha) was that Arm D mean was different from Arm A mean.||1.59|-4.62|0.5309
72385066|NCT02484690|144277982|SUPERIORITY||Difference in Least Squares Means|-1.68||||0.3034|TWO_SIDED|80.0|-3.77|0.42||The threshold for statistical significance was an unadjusted 2-sided p-value \<0.2. There was no formal correction for multiple comparisons.|Mixed Model for Repeated Measures|Categorical covariates(cov): RAP/PCV at baseline(BL), treatment group, visit, \& visit by treatment group; Continuous cov: BCVA at BL; Unstructured cov|The mean difference was calculated as Arm E minus Arm A.|The null hypothesis (Ho) was that there was no difference in means between the treatment group (Arm E) and the control group (Arm A). The alternative hypothesis (Ha) was that the Arm E mean was different from Arm A mean.||0.42|-3.77|0.3034
72385067|NCT02484690|144277983|SUPERIORITY||Difference in Least Squares Means|5.63||||0.5527|TWO_SIDED|80.0|-6.52|17.77||The threshold for statistical significance was an unadjusted 2-sided p-value \<0.2. There was no formal correction for multiple comparisons.|Generalized Estimating Equations Model|Categorical covariates: treatment group, visit, and visit by treatment group interaction. An AR(1) covariance structure was also used.|The mean difference was calculated as Arm B minus Arm A.|The null hypothesis (Ho) was that there was no difference in means between the treatment group (Arm B) and the control group (Arm A). The alternative hypothesis (Ha) was that Arm B mean was different from Arm A mean.||17.77|-6.52|0.5527
72437416|NCT00880048|144388153|SUPERIORITY||Mean Difference (Net)|-12.92||||0.1933|TWO_SIDED|95.0|-32.43|6.59|||Mixed Models Repeated Measures|||Placebo va GW823296 30 mg: Week 4, sleep onset latency||6.59|-32.43|0.1933
72385068|NCT02484690|144277983|SUPERIORITY||Difference in Least Squares Means|-3.09||||0.7382|TWO_SIDED|80.0|-14.95|8.76||The threshold for statistical significance was an unadjusted 2-sided p-value \<0.2. There was no formal correction for multiple comparisons.|Generalized Estimating Equations Model|Categorical covariates: treatment group, visit, and visit by treatment group interaction. An AR(1) covariance structure was also used.|The mean difference was calculated as Arm C minus Arm A.|The null hypothesis (Ho) was that there was no difference in means between the treatment group (Arm C) and the control group (Arm A). The alternative hypothesis (Ha) was that Arm C mean was different from Arm A mean.||8.76|-14.95|0.7382
72385069|NCT02484690|144277983|SUPERIORITY||Difference in Least Squares Means|-7.32||||0.3932|TWO_SIDED|80.0|-18.32|3.67||The threshold for statistical significance was an unadjusted 2-sided p-value \<0.2. There was no formal correction for multiple comparisons.|Generalized Estimating Equations Model|Categorical covariates: treatment group, visit, and visit by treatment group interaction. An AR(1) covariance structure was also used.|The mean difference was calculated as Arm D minus Arm A.|The null hypothesis (Ho) was that there was no difference in means between the treatment group (Arm D) and the control group (Arm A). The alternative hypothesis (Ha) was that Arm D mean was different from Arm A mean.||3.67|-18.32|0.3932
72385070|NCT02484690|144277984|SUPERIORITY||Difference in Percentage of Participants|-5.71||||0.2328|TWO_SIDED|80.0|-10.74|-0.69||The threshold for statistical significance was an unadjusted 2-sided p-value \<0.2. There was no formal correction for multiple comparisons.|Fisher Exact||The difference was calculated as Arm E minus Arm A.|The null hypothesis (Ho) was that there was no difference between the treatment group (Arm E) and the control group (Arm A). The alternative hypothesis (Ha) was that Arm E was different from Arm A.||-0.69|-10.74|0.2328
72385071|NCT02484690|144277985|SUPERIORITY||Difference in Least Squares Means|-0.52||||0.9581|TWO_SIDED|80.0|-13.26|12.22||The threshold for statistical significance was an unadjusted 2-sided p-value \<0.2. There was no formal correction for multiple comparisons.|Generalized Estimating Equations Model|Categorical covariates: treatment group, visit, and visit by treatment group interaction. An AR(1) covariance structure was also used.|The mean difference was calculated as Arm B minus Arm A.|The null hypothesis (Ho) was that there was no difference in means between the treatment group (Arm B) and the control group (Arm A). The alternative hypothesis (Ha) was that Arm B mean was different from Arm A mean.||12.22|-13.26|0.9581
72385072|NCT02484690|144277985|SUPERIORITY||Difference in Least Squares Means|-10.08||||0.3166|TWO_SIDED|80.0|-22.99|2.82||The threshold for statistical significance was an unadjusted 2-sided p-value \<0.2. There was no formal correction for multiple comparisons.|Generalized Estimating Equations Model|Categorical covariates: treatment group, visit, and visit by treatment group interaction. An AR(1) covariance structure was also used.|The mean difference was calculated as Arm C minus Arm A.|The null hypothesis (Ho) was that there was no difference in means between the treatment group (Arm C) and the control group (Arm A). The alternative hypothesis (Ha) was that Arm C mean was different from Arm A mean.||2.82|-22.99|0.3166
72385073|NCT02484690|144277985|SUPERIORITY||Difference in Least Squares Means|-7.68||||0.4244|TWO_SIDED|80.0|-20.01|4.64||The threshold for statistical significance was an unadjusted 2-sided p-value \<0.2. There was no formal correction for multiple comparisons.|Generalized Estimating Equations Model|Categorical covariates: treatment group, visit, and visit by treatment group interaction. An AR(1) covariance structure was also used.|The mean difference was calculated as Arm D minus Arm A.|The null hypothesis (Ho) was that there was no difference in means between the treatment group (Arm D) and the control group (Arm A). The alternative hypothesis (Ha) was that Arm D mean was different from Arm A mean.||4.64|-20.01|0.4244
72385074|NCT02484690|144277986|SUPERIORITY||Difference in Percentage of Participants|-6.64||||0.5586|TWO_SIDED|80.0|-18.6|5.32||The threshold for statistical significance was an unadjusted 2-sided p-value \<0.2. There was no formal correction for multiple comparisons.|Fisher Exact||The difference was calculated as Arm E minus Arm A.|The null hypothesis (Ho) was that there was no difference between the treatment group (Arm E) and the control group (Arm A). The alternative hypothesis (Ha) was that Arm E was different from Arm A.||5.32|-18.60|0.5586
72385075|NCT02484690|144277987|SUPERIORITY||Difference in Least Squares Means|1.0||||0.8536|TWO_SIDED|80.0|-5.93|7.93||The threshold for statistical significance was an unadjusted 2-sided p-value \<0.2. There was no formal correction for multiple comparisons.|Generalized Estimating Equations Model|Categorical covariates: treatment group, visit, and visit by treatment group interaction. An AR(1) covariance structure was also used.|The mean difference was calculated as Arm B minus Arm A.|The null hypothesis (Ho) was that there was no difference in means between the treatment group (Arm B) and the control group (Arm A). The alternative hypothesis (Ha) was that Arm B mean was different from Arm A mean.||7.93|-5.93|0.8536
72385076|NCT02484690|144277987|SUPERIORITY||Difference in Least Squares Means|8.14||||0.2303|TWO_SIDED|80.0|-0.56|16.83||The threshold for statistical significance was an unadjusted 2-sided p-value \<0.2. There was no formal correction for multiple comparisons.|Generalized Estimating Equations Model|Categorical covariates: treatment group, visit, and visit by treatment group interaction. An AR(1) covariance structure was also used.|The mean difference was calculated as Arm C minus Arm A.|The null hypothesis (Ho) was that there was no difference in means between the treatment group (Arm C) and the control group (Arm A). The alternative hypothesis (Ha) was that Arm C mean was different from Arm A mean.||16.83|-0.56|0.2303
72437417|NCT00880048|144388153|SUPERIORITY||Mean Difference (Net)|-10.55||||0.2933|TWO_SIDED|95.0|-30.26|9.17|||Mixed Models Repeated Measures|||Placebo vs GW823296 60 mg: Week 4, sleep onset latency||9.17|-30.26|0.2933
72437418|NCT00880048|144388153|SUPERIORITY||Mean Difference (Net)|-28.58||||0.0177|TWO_SIDED|95.0|-52.15|-5.01|||Mixed Models Repeated Measures|||Placebo vs GW823296 30 mg: Week 6, sleep onset latency||-5.01|-52.15|0.0177
72437419|NCT00880048|144388153|SUPERIORITY||Mean Difference (Net)|-30.07||||0.0152|TWO_SIDED|95.0|-54.29|-5.84|||Mixed Models Repeated Measures|||Placebo vs GW823296 60 mg: Week 6, sleep onset latency||-5.84|-54.29|0.0152
72437420|NCT00880048|144388153|SUPERIORITY||Mean Difference (Net)|-17.19||||0.0108|TWO_SIDED|95.0|-30.36|-4.01|||Mixed Models Repeated Measures|||Placebo vs GW823296 30 mg: Week 1, wake time after sleep onset||-4.01|-30.36|0.0108
72385077|NCT02484690|144277987|SUPERIORITY||Difference in Least Squares Means|1.08||||0.8406|TWO_SIDED|80.0|-5.79|7.95||The threshold for statistical significance was an unadjusted 2-sided p-value \<0.2. There was no formal correction for multiple comparisons.|Generalized Estimating Equations Model|Categorical covariates: treatment group, visit, and visit by treatment group interaction. An AR(1) covariance structure was also used.|The mean difference was calculated as Arm D minus Arm A.|The null hypothesis (Ho) was that there was no difference in means between the treatment group (Arm D) and the control group (Arm A). The alternative hypothesis (Ha) was that Arm D mean was different from Arm A mean.||7.95|-5.79|0.8406
72385078|NCT02484690|144277988|SUPERIORITY||Difference in Percentage of Participants|-0.77||||1|TWO_SIDED|80.0|-11.23|9.68||The threshold for statistical significance was an unadjusted 2-sided p-value \<0.2. There was no formal correction for multiple comparisons.|Fisher Exact||The difference was calculated as Arm E minus Arm A.|The null hypothesis (Ho) was that there was no difference between the treatment group (Arm E) and the control group (Arm A). The alternative hypothesis (Ha) was that Arm E was different from Arm A.||9.68|-11.23|1.0000
72385079|NCT02484690|144277989|SUPERIORITY||Difference in Least Squares Means|12.65||||0.3798|TWO_SIDED|80.0|-5.81|31.11||The threshold for statistical significance was an unadjusted 2-sided p-value \<0.2. There was no formal correction for multiple comparisons.|Mixed Model for Repeated Measures|Categorical covariates(cov): RAP/PCV at baseline(BL), treatment group, visit, \& visit by treatment group; Continuous cov: FCPT at BL; Unstructured cov|The mean difference was calculated as Arm B minus Arm A.|The null hypothesis (Ho) was that there was no difference in means between the treatment group (Arm B) and the control group (Arm A). The alternative hypothesis (Ha) was that Arm B mean was different from Arm A mean.||31.11|-5.81|0.3798
72385080|NCT02484690|144277989|SUPERIORITY||Difference in Least Squares Means|0.88||||0.9529|TWO_SIDED|80.0|-18.3|20.03||The threshold for statistical significance was an unadjusted 2-sided p-value \<0.2. There was no formal correction for multiple comparisons.|Mixed Model for Repeated Measures|Categorical covariates(cov): RAP/PCV at baseline(BL), treatment group, visit, \& visit by treatment group; Continuous cov: FCPT at BL; Unstructured cov|The mean difference was calculated as Arm C minus Arm A.|The null hypothesis (Ho) was that there was no difference in means between the treatment group (Arm C) and the control group (Arm A). The alternative hypothesis (Ha) was that Arm C mean was different from Arm A mean.||20.03|-18.3|0.9529
72385081|NCT02484690|144277989|SUPERIORITY||Difference in Least Squares Means|32.81||||0.0208|TWO_SIDED|80.0|14.65|50.96||The threshold for statistical significance was an unadjusted 2-sided p-value \<0.2. There was no formal correction for multiple comparisons.|Mixed Model for Repeated Measures|Categorical covariates(cov): RAP/PCV at baseline(BL), treatment group, visit, \& visit by treatment group; Continuous cov: FCPT at BL; Unstructured cov|The mean difference was calculated as Arm D minus Arm A.|The null hypothesis (Ho) was that there was no difference in means between the treatment group (Arm D) and the control group (Arm A). The alternative hypothesis (Ha) was that Arm D mean was different from Arm A mean.||50.96|14.65|0.0208
72385082|NCT02484690|144277990|SUPERIORITY||Difference in Least Squares Means|-6.35||||0.5185|TWO_SIDED|80.0|-19.0|6.27||The threshold for statistical significance was an unadjusted 2-sided p-value \<0.2. There was no formal correction for multiple comparisons.|Mixed Model for Repeated Measures|Categorical covariates(cov): RAP/PCV at baseline(BL), treatment group, visit, \& visit by treatment group; Continuous cov: FCPT at BL; Unstructured cov|The mean difference was calculated as Arm E minus Arm A.|The null hypothesis (Ho) was that there was no difference between the treatment group (Arm E) and the control group (Arm A). The alternative hypothesis (Ha) was that Arm E was different from Arm A.||6.27|-19.0|0.5185
72437421|NCT00880048|144388153|SUPERIORITY||Mean Difference (Net)|-16.15||||0.019|TWO_SIDED|95.0|-29.61|-2.68|||Mixed Models Repeated Measures|||Placebo vs GW823296 60 mg: Week 1, wake time after sleep onset||-2.68|-29.61|0.0190
72437422|NCT00880048|144388153|SUPERIORITY||Mean Difference (Net)|1.89||||0.8195|TWO_SIDED|95.0|-14.43|18.21|||Mixed Models Repeated Measures|||Placebo vs GW823296 30 mg: Week 2, wake time after sleep onset||18.21|-14.43|0.8195
72437423|NCT00880048|144388153|SUPERIORITY||Mean Difference (Net)|5.27||||0.5327|TWO_SIDED|95.0|-11.35|21.89|||Mixed Models Repeated Measures|||Placebo vs GW823296 60 mg: Week 2, wake time after sleep onset||21.89|-11.35|0.5327
72437424|NCT00880048|144388153|SUPERIORITY||Mean Difference (Net)|-2.5||||0.7387|TWO_SIDED|95.0|-17.24|12.25|||Mixed Models Repeated Measures|||Placebo vs GW823296 30 mg: Week 4, wake time after sleep onset||12.25|-17.24|0.7387
72385083|NCT02484690|144277991|SUPERIORITY||Difference in Least Squares Means|19.45||||0.1624|TWO_SIDED|80.0|1.61|37.29||The threshold for statistical significance was an unadjusted 2-sided p-value \<0.2. There was no formal correction for multiple comparisons.|Mixed Model for Repeated Measures|Categorical covariates(cov): RAP/PCV at baseline(BL), treatment group, visit, \& visit by treatment group; Continuous cov: CST at BL; Unstructured cov|The mean difference was calculated as Arm B minus Arm A.|The null hypothesis (Ho) was that there was no difference in means between the treatment group (Arm B) and the control group (Arm A). The alternative hypothesis (Ha) was that Arm B mean was different from Arm A mean.||37.29|1.61|0.1624
72437425|NCT00880048|144388153|SUPERIORITY||Mean Difference (Net)|-9.44||||0.2134|TWO_SIDED|95.0|-24.35|5.48|||Mixed Models Repeated Measures|||Placebo vs GW823296 60 mg: Week 4, wake time after sleep onset||5.48|-24.35|0.2134
72437426|NCT00880048|144388153|SUPERIORITY||Mean Difference (Net)|-14.51||||0.1561|TWO_SIDED|95.0|-34.61|5.6|||Mixed Models Repeated Measures|||Placebo vs GW823296 30 mg: Week 6, wake time after sleep onset||5.60|-34.61|0.1561
72437427|NCT00880048|144388153|SUPERIORITY||Mean Difference (Net)|-17.1||||0.1054|TWO_SIDED|95.0|-37.84|3.64|||Mixed Models Repeated Measures|||Placebo vs GW823296 60 mg: Week 6, wake time after sleep onset||3.64|-37.84|0.1054
72437428|NCT00880048|144388154|SUPERIORITY||Mean Difference (Net)|-0.57||||0.0024|TWO_SIDED|95.0|-0.94|-0.21|||Mixed Models Repeated Measures|||Placebo vs GW823296 30 mg: Week 1||-0.21|-0.94|0.0024
72437429|NCT00880048|144388154|SUPERIORITY||Mean Difference (Net)|-0.1||||0.6146|TWO_SIDED|95.0|-0.47|0.28|||Mixed Models Repeated Measures|||Placebo vs GW823296 60 mg: Week 1||0.28|-0.47|0.6146
72437430|NCT00880048|144388154|SUPERIORITY||Mean Difference (Net)|-0.25||||0.1442|TWO_SIDED|95.0|-0.59|0.09|||Mixed Models Repeated Measures|||Placebo vs GW823296 30 mg: Week 2||0.09|-0.59|0.1442
72558495|NCT00112437|144646489|SUPERIORITY_OR_OTHER||Difference in Least square means|1.11||||0.028||95.0|-0.12|2.34||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through a stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on Total Body BMD compared to placebo over 24 months. The secondary hypothesis states that odanacatib will increase Total Body BMD compared to placebo over 24 months.||2.34|-0.12|0.028
72558496|NCT00112437|144646489|SUPERIORITY_OR_OTHER||Difference in Least square means|0.2||||0.804||95.0|-1.1|1.49||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through a stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on Total Body BMD compared to placebo over 24 months. The secondary hypothesis states that odanacatib will increase Total Body BMD compared to placebo over 24 months.||1.49|-1.10|0.804
72558497|NCT00112437|144646489|SUPERIORITY_OR_OTHER||Difference in Least square means|-1.15|||||TWO_SIDED|95.0|-2.46|0.15||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through a stepdown trend-test approach. Multiplicity for multiple endpoints was handle by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on Total Body BMD compared to placebo over 24 months. The secondary hypothesis states that odanacatib will increase Total Body BMD compared to placebo over 24 months.||0.15|-2.46|
72558498|NCT00112437|144646490|SUPERIORITY_OR_OTHER||Difference in Least square means|2.9|||<=|0.001|TWO_SIDED|95.0|1.34|4.46||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on Distal Forearm BMD compared to placebo over 24 months. The secondary hypothesis states that odanacatib will increase Distal Forearm BMD compared to placebo over 24 months.||4.46|1.34|<=0.001
72558499|NCT00112437|144646490|SUPERIORITY_OR_OTHER||Difference in Least square means|2.09|||<=|0.001||95.0|0.59|3.6||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on Distal Forearm BMD compared to placebo over 24 months. The secondary hypothesis states that odanacatib will increase Distal Forearm BMD compared to placebo over 24 months.||3.60|0.59|<=0.001
72558500|NCT00112437|144646490|SUPERIORITY_OR_OTHER||Difference in Least square means|1.53||||0.094||95.0|-0.01|3.07||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on Distal Forearm BMD compared to placebo over 24 months. The secondary hypothesis states that odanacatib will increase Distal Forearm BMD compared to placebo over 24 months.||3.07|-0.01|0.094
72558501|NCT00112437|144646490|SUPERIORITY_OR_OTHER||Difference in Least square means|-2.95||||||95.0|-4.5|-1.4||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handle by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on Distal Forearm BMD compared to placebo over 24 months. The secondary hypothesis states that odanacatib will increase Distal Forearm BMD compared to placebo over 24 months.||-1.40|-4.50|
72618806|NCT01117350|144768143|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.54||||0.439|TWO_SIDED|95.0|-3.88|8.93||"If superiority not demonstrated, switching from superiority to non-inferiority considered.~Conclusion of non-inferiority reached if lower limit of 2-sided 95% confidence interval of the difference (insulin glargine - liraglutide) \> or = to - 3.5%"|Chi-squared|||"Superiority testing~H0: Rate measured with insulin glargine = rate measured with liraglutide~H1: Rate measured with insulin glargine ≠ rate measured with liraglutide~Sample size calculation (465 randomized patients per arm) was based on the assumption of an expected success rate of 46% with insulin glargine and 35% with liraglutide, an alpha risk of 5% (2-sided) and a power of 90%, taking into account an estimated non evaluability rate of 10%."||8.93|-3.88|0.439
72385084|NCT02484690|144277991|SUPERIORITY||Difference in Least Squares Means|2.79||||0.8475|TWO_SIDED|80.0|-15.8|21.37||The threshold for statistical significance was an unadjusted 2-sided p-value \<0.2. There was no formal correction for multiple comparisons.|Mixed Model for Repeated Measures|Categorical covariates(cov): RAP/PCV at baseline(BL), treatment group, visit, \& visit by treatment group; Continuous cov: CST at BL; Unstructured cov|The mean difference was calculated as Arm C minus Arm A.|The null hypothesis (Ho) was that there was no difference in means between the treatment group (Arm C) and the control group (Arm A). The alternative hypothesis (Ha) was that Arm C mean was different from Arm A mean.||21.37|-15.8|0.8475
72437431|NCT00880048|144388154|SUPERIORITY||Mean Difference (Net)|0.04||||0.8001|TWO_SIDED|95.0|-0.3|0.39|||Mixed Models Repeated Measures|||Placebo vs GW823296 60 mg: Week 2||0.39|-0.30|0.8001
72385085|NCT02484690|144277991|SUPERIORITY||Difference in Least Squares Means|28.52||||0.0381|TWO_SIDED|80.0|10.93|46.11||The threshold for statistical significance was an unadjusted 2-sided p-value \<0.2. There was no formal correction for multiple comparisons.|Mixed Model for Repeated Measures|Categorical covariates(cov): RAP/PCV at baseline(BL), treatment group, visit, \& visit by treatment group; Continuous cov: CST at BL; Unstructured cov|The mean difference was calculated as Arm D minus Arm A.|The null hypothesis (Ho) was that there was no difference in means between the treatment group (Arm D) and the control group (Arm A). The alternative hypothesis (Ha) was that Arm D mean was different from Arm A mean.||46.11|10.93|0.0381
72385086|NCT02484690|144277992|SUPERIORITY||Difference in Least Squares Means|-14.4||||0.2089|TWO_SIDED|80.0|-29.1|0.29||The threshold for statistical significance was an unadjusted 2-sided p-value \<0.2. There was no formal correction for multiple comparisons.|Mixed Model for Repeated Measures|Categorical covariates(cov): RAP/PCV at baseline(BL), treatment group, visit, \& visit by treatment group; Continuous cov: CST at BL; Unstructured cov|The mean difference was calculated as Arm E minus Arm A.|The null hypothesis (Ho) was that there was no difference between the treatment group (Arm E) and the control group (Arm A). The alternative hypothesis (Ha) was that Arm E was different from Arm A.||0.29|-29.1|0.2089
72385087|NCT02484690|144277995|SUPERIORITY||Difference in Least Squares Means|-0.4||||0.6717|TWO_SIDED|80.0|-1.61|0.81||The threshold for statistical significance was an unadjusted 2-sided p-value \<0.2. There was no formal correction for multiple comparisons.|Mixed Model for Repeated Measures|Categorical covariates(cov): RAP/PCV at baseline(BL), treatment group, visit, \& visit by treatment group; Continuous cov: CNV at BL; Unstructured cov|The mean difference was calculated as Arm B minus Arm A.|The null hypothesis (Ho) was that there was no difference in means between the treatment group (Arm B) and the control group (Arm A). The alternative hypothesis (Ha) was that Arm B mean was different from Arm A mean.||0.81|-1.61|0.6717
72385088|NCT02484690|144277995|SUPERIORITY||Difference in Least Squares Means|0.23||||0.8131|TWO_SIDED|80.0|-1.01|1.47||The threshold for statistical significance was an unadjusted 2-sided p-value \<0.2. There was no formal correction for multiple comparisons.|Mixed Model for Repeated Measures|Categorical covariates(cov): RAP/PCV at baseline(BL), treatment group, visit, \& visit by treatment group; Continuous cov: CNV at BL; Unstructured cov|The mean difference was calculated as Arm C minus Arm A.|The null hypothesis (Ho) was that there was no difference in means between the treatment group (Arm C) and the control group (Arm A). The alternative hypothesis (Ha) was that Arm C mean was different from Arm A mean.||1.47|-1.01|0.8131
72385089|NCT02484690|144277995|SUPERIORITY||Difference in Least Squares Means|0.11||||0.9069|TWO_SIDED|80.0|-1.07|1.29||The threshold for statistical significance was an unadjusted 2-sided p-value \<0.2. There was no formal correction for multiple comparisons.|Mixed Model for Repeated Measures|Categorical covariates(cov): RAP/PCV at baseline(BL), treatment group, visit, \& visit by treatment group; Continuous cov: CNV at BL; Unstructured cov|The mean difference was calculated as Arm D minus Arm A.|The null hypothesis (Ho) was that there was no difference in means between each of the treatment groups (Arms B, C, or D) and the control group (Arm A). The alternative hypothesis (Ha) was that Arms B, C, or D means were different from Arm A mean.||1.29|-1.07|0.9069
72385090|NCT02484690|144277997|SUPERIORITY||Difference in Least Squares Means|-0.96||||0.3189|TWO_SIDED|80.0|-2.2|0.28||The threshold for statistical significance was an unadjusted 2-sided p-value \<0.2. There was no formal correction for multiple comparisons.|Mixed Model for Repeated Measures|Categorical covariates(cov): RAP/PCV at baseline(BL), treatment group, visit, \& visit by treatment group; Continuous cov: CNV at BL; Unstructured cov|The mean difference was calculated as Arm B minus Arm A.|The null hypothesis (Ho) was that there was no difference in means between the treatment group (Arm B) and the control group (Arm A). The alternative hypothesis (Ha) was that Arm B mean was different from Arm A mean.||0.28|-2.20|0.3189
72437432|NCT00880048|144388154|SUPERIORITY||Mean Difference (Net)|-0.05||||0.8439|TWO_SIDED|95.0|-0.55|0.45|||Mixed Models Repeated Measures|||Placebo vs GW823296 30 mg: Week 4||0.45|-0.55|0.8439
72437433|NCT00880048|144388154|SUPERIORITY||Mean Difference (Net)|-0.4||||0.1259|TWO_SIDED|95.0|-0.91|0.11|||Mixed Models Repeated Measures|||Placebo vs GW823296 60 mg: Week 4||0.11|-0.91|0.1259
72437434|NCT00880048|144388154|SUPERIORITY||Mean Difference (Net)|0.2||||0.3709|TWO_SIDED|95.0|-0.24|0.64|||Mixed Models Repeated Measures|||Placebo vs GW823296 30 mg: Week 6||0.64|-0.24|0.3709
72437435|NCT00880048|144388154|SUPERIORITY||Mean Difference (Net)|-0.24||||0.2993|TWO_SIDED|95.0|-0.7|0.22|||Mixed Models Repeated Measures|||Placebo vs GW823296 60 mg: Week 6||0.22|-0.70|0.2993
72495079|NCT05227690|144519242|SUPERIORITY|Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.|LS Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|2.26|=|0.6007|TWO_SIDED|95.0|-5.6|3.3|||Mixed Model for Repeated Measures (MMRM)||Emraclidine 10 mg - Placebo|Week 6-- Emraclidine 10 mg versus Placebo||3.3|-5.6|=0.6007
72437436|NCT00880048|144388155|SUPERIORITY||Mean Difference (Net)|0.59||||0.0344|TWO_SIDED|95.0|0.04|1.14|||Mixed Models Repeated Measures|||Placebo vs GW823296 30 mg: Week 1, sleep quality||1.14|0.04|0.0344
72437437|NCT00880048|144388155|SUPERIORITY||Mean Difference (Net)|0.72||||0.0111|TWO_SIDED|95.0|0.17|1.27|||Mixed Models Repeated Measures|||Placebo vs GW823296 60 mg: Week 1, sleep quality||1.27|0.17|0.0111
72437438|NCT00880048|144388155|SUPERIORITY||Mean Difference (Net)|0.42||||0.1443|TWO_SIDED|95.0|-0.15|0.99|||Mixed Models Repeated Measures|||Placebo vs GW823296 30 mg: Week 2, sleep quality||0.99|-0.15|0.1443
72437439|NCT00880048|144388155|SUPERIORITY||Mean Difference (Net)|0.5||||0.0873|TWO_SIDED|95.0|-0.07|1.08|||Mixed Models Repeated Measures|||Placebo vs GW823296 60 mg: Week 2, sleep quality||1.08|-0.07|0.0873
72437440|NCT00880048|144388155|SUPERIORITY||Mean Difference (Net)|0.73||||0.017|TWO_SIDED|95.0|0.13|1.33|||Mixed Models Repeated Measures|||Placebo vs GW823296 30 mg: Week 4, sleep quality||1.33|0.13|0.0170
72437441|NCT00880048|144388155|SUPERIORITY||Mean Difference (Net)|0.42||||0.1675|TWO_SIDED|95.0|-0.18|1.02|||Mixed Models Repeated Measures|||Placebo vs GW823296 60 mg: Week 4, sleep quality||1.02|-0.18|0.1675
72437442|NCT00880048|144388155|SUPERIORITY||Mean Difference (Net)|0.56||||0.0956|TWO_SIDED|95.0|-0.1|1.23|||Mixed Models Repeated Measures|||Placebo vs GW823296 30 mg: Week 6, sleep quality||1.23|-0.10|0.0956
72558502|NCT00112437|144646491|SUPERIORITY_OR_OTHER||Difference in Least Square Means|-47.21|||<=|0.001||95.0|-64.51|-29.9||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance.|Difference in Least Square Means (back-transformation of difference in log-fraction from baseline)|The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone resorption (u-NTx) compared to placebo over 24 months. The secondary hypothesis states that odanacatib will decrease biochemical indices of bone resorption (u-NTx) over 24 months.||-29.90|-64.51|<=0.001
72558503|NCT00112437|144646491|SUPERIORITY_OR_OTHER||Difference in Least Square Means|-33.67|||<=|0.001||95.0|-51.44|-15.91||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance.|Difference in Least Square Means (back-transformation of difference in log-fraction from baseline)|The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone resorption (u-NTx) compared to placebo over 24 months. The secondary hypothesis states that odanacatib will decrease biochemical indices of bone resorption (u-NTx) over 24 months.||-15.91|-51.44|<=0.001
72558504|NCT00112437|144646491|SUPERIORITY_OR_OTHER||Difference in Least Square Means|-35.94|||<=|0.001||95.0|-54.15|-17.74||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance.|Difference in Least Square Means (back-transformation of difference in log-fraction from baseline)|The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone resorption (u-NTx) compared to placebo over 24 months. The secondary hypothesis states that odanacatib will decrease biochemical indices of bone resorption (u-NTx) over 24 months.||-17.74|-54.15|<=0.001
72558505|NCT00112437|144646491|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|17.51||||0.101|TWO_SIDED|95.0|-6.78|41.8||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handle by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance.|Difference in Least Square Means (back-transformation of difference in log-fraction from baseline)|The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone resorption (u-NTx) compared to placebo over 24 months. The secondary hypothesis states that odanacatib will decrease biochemical indices of bone resorption (u-NTx) over 24 months.||41.80|-6.78|0.101
72495080|NCT05227690|144519243|SUPERIORITY|Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.|LS Mean Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.061|=|0.5822|TWO_SIDED|95.0|-0.15|0.09|||Mixed Model for Repeated Measures (MMRM)||Emraclidine 30 mg - Placebo|Week 1-- Emraclidine 30 mg versus Placebo||0.09|-0.15|=0.5822
72495081|NCT05227690|144519243|SUPERIORITY|Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.|LS Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.061|=|0.9244|TWO_SIDED|95.0|-0.11|0.13|||Mixed Model for Repeated Measures (MMRM)||Emraclidine 10 mg - Placebo|Week 1-- Emraclidine 10 mg versus Placebo||0.13|-0.11|=0.9244
72495082|NCT05227690|144519243|SUPERIORITY|Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.|LS Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.088|=|0.9348|TWO_SIDED|95.0|-0.17|0.18|||Mixed Model for Repeated Measures (MMRM)||Emraclidine 30 mg - Placebo|Week 2-- Emraclidine 30 mg versus Placebo||0.18|-0.17|=0.9348
72558506|NCT00112437|144646492|SUPERIORITY_OR_OTHER||Difference in Least Square Means|-63.34|||<=|0.001||95.0|-88.32|-38.36||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance.|Difference in Least Square Means (back-transformation of difference in log-fraction from baseline).|The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone resorption (s-CTx) compared to placebo over 24 months. The secondary hypothesis states that odanacatib will decrease biochemical indices of bone resorption (s-CTx) over 24 months.||-38.36|-88.32|<=0.001
72558507|NCT00112437|144646492|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-39.29|||<=|0.001|TWO_SIDED|95.0|-65.4|-13.18||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance.|Difference in Least Squares Means (back-transformation of difference in log-fraction from baseline).|The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone resorption (s-CTx) compared to placebo over 24 months. The secondary hypothesis states that odanacatib will decrease biochemical indices of bone resorption (s-CTx) over 24 months.||-13.18|-65.40|<=0.001
72437443|NCT00880048|144388155|SUPERIORITY||Mean Difference (Net)|0.32||||0.3503|TWO_SIDED|95.0|-0.35|1.0|||Mixed Models Repeated Measures|||Placebo vs GW823296 60 mg: Week 6, sleep quality||1.00|-0.35|0.3503
72437444|NCT00880048|144388155|SUPERIORITY||Mean Difference (Net)|0.34||||0.2147|TWO_SIDED|95.0|-0.2|0.88|||Mixed Models Repeated Measures|||Placebo vs GW823296 30 mg: Week 1, refreshing value of sleep||0.88|-0.20|0.2147
72437445|NCT00880048|144388155|SUPERIORITY||Mean Difference (Net)|0.63||||0.0233|TWO_SIDED|95.0|0.09|1.17|||Mixed Models Repeated Measures|||Placebo vs GW823296 60 mg: Week 1, refreshing value of sleep||1.17|0.09|0.0233
72437446|NCT00880048|144388155|SUPERIORITY||Mean Difference (Net)|0.33||||0.2404|TWO_SIDED|95.0|-0.22|0.89|||Mixed Models Repeated Measures|||Placebo vs GW823296 30 mg: Week 2, refreshing value of sleep||0.89|-0.22|0.2404
72437447|NCT00880048|144388155|SUPERIORITY||Mean Difference (Net)|0.65||||0.0247|TWO_SIDED|95.0|0.08|1.22|||Mixed Models Repeated Measures|||Placebo vs GW823296 60 mg: Week 2, refreshing value of sleep||1.22|0.08|0.0247
72437448|NCT00880048|144388155|SUPERIORITY||Mean Difference (Net)|0.69||||0.0271|TWO_SIDED|95.0|0.08|1.29|||Mixed Models Repeated Measures|||Placebo vs GW823296 30 mg: Week 4, refreshing value of sleep||1.29|0.08|0.0271
72437449|NCT00880048|144388155|SUPERIORITY||Mean Difference (Net)|0.39||||0.2129|TWO_SIDED|95.0|-0.22|1.0|||Mixed Models Repeated Measures|||Placebo vs GW823296 60 mg: Week 4, refreshing value of sleep||1.00|-0.22|0.2129
72437450|NCT00880048|144388155|SUPERIORITY||Mean Difference (Net)|0.37||||0.2874|TWO_SIDED|95.0|-0.31|1.06|||Mixed Models Repeated Measures|||Placebo vs GW823296 30 mg: Week 6, refreshing value of sleep||1.06|-0.31|0.2874
72437451|NCT00880048|144388155|SUPERIORITY||Mean Difference (Net)|0.71||||0.0472|TWO_SIDED|95.0|0.01|1.41|||Mixed Models Repeated Measures|||Placebo vs GW823296 60 mg: Week 6, refreshing value of sleep||1.41|0.01|0.0472
72437452|NCT00880048|144388156|SUPERIORITY||Odds Ratio (OR)|0.98||||0.9824|TWO_SIDED|95.0|0.13|7.09|||Regression, Logistic|||Placebo vs GW823296 30 mg: Week 1||7.09|0.13|0.9824
72437453|NCT00880048|144388156|SUPERIORITY||Odds Ratio (OR)|0.54||||0.6227|TWO_SIDED|95.0|0.05|6.13|||Regression, Logistic|||Placebo vs GW823296 60 mg: Week 1||6.13|0.05|0.6227
72437454|NCT00880048|144388156|SUPERIORITY||Odds Ratio (OR)|1.0||||0.9967|TWO_SIDED|95.0|0.2|5.07|||Regression, Logistic|||Placebo vs GW823296 30 mg: Week 2||5.07|0.20|0.9967
72437455|NCT00880048|144388156|SUPERIORITY||Odds Ratio (OR)|2.0||||0.355|TWO_SIDED|95.0|0.46|8.63|||Regression, Logistic|||Placebo vs GW823296 60 mg: Week 2||8.63|0.46|0.3550
72437456|NCT00880048|144388156|SUPERIORITY||Odds Ratio (OR)|2.35||||0.1009|TWO_SIDED|95.0|0.85|6.49|||Regression, Logistic|||Placebo vs GW823296 30 mg: Week 4||6.49|0.85|0.1009
72437457|NCT00880048|144388156|SUPERIORITY||Odds Ratio (OR)|2.8||||0.0455|TWO_SIDED|95.0|1.02|7.68|||Regression, Logistic|||Placebo vs GW823296 60 mg: Week 4||7.68|1.02|0.0455
72437458|NCT00880048|144388156|SUPERIORITY||Odds Ratio (OR)|2.3||||0.0507|TWO_SIDED|95.0|1.0|5.32|||Regression, Logistic|||Placebo vs GW823296 30 mg: Week 6||5.32|1.00|0.0507
72437459|NCT00880048|144388156|SUPERIORITY||Odds Ratio (OR)|1.38||||0.4962|TWO_SIDED|95.0|0.55|3.45|||Regression, Logistic|||Placebo vs GW823296 60 mg: Week 6||3.45|0.55|0.4962
72437460|NCT00880048|144388159|SUPERIORITY||Mean Difference (Net)|1.03||||0.3241|TWO_SIDED|95.0|-1.03|3.1|||Mixed Models Repeated Measures|||Placebo vs GW823296 30 mg: Week 1||3.10|-1.03|0.3241
72437461|NCT00880048|144388159|SUPERIORITY||Mean Difference (Net)|-0.56||||0.602|TWO_SIDED|95.0|-2.66|1.55|||Mixed Models Repeated Measures|||Placebo vs GW823296 60 mg: Week 1||1.55|-2.66|0.6020
72437462|NCT00880048|144388159|SUPERIORITY||Mean Difference (Net)|2.44||||0.0594|TWO_SIDED|95.0|-0.1|4.99|||Mixed Models Repeated Measures|||Placebo vs GW823296 30 mg: Week 2||4.99|-0.10|0.0594
72437463|NCT00880048|144388159|SUPERIORITY||Mean Difference (Net)|0.92||||0.4828|TWO_SIDED|95.0|-1.67|3.5|||Mixed Models Repeated Measures|||Placebo vs GW823296 60 mg: Week 2||3.50|-1.67|0.4828
72437464|NCT00880048|144388159|SUPERIORITY||Mean Difference (Net)|0.19||||0.9008|TWO_SIDED|95.0|-2.8|3.18|||Mixed Models Repeated Measures|||Placebo vs GW823296 30 mg: Week 4||3.18|-2.80|0.9008
72437465|NCT00880048|144388159|SUPERIORITY||Mean Difference (Net)|-0.71||||0.6428|TWO_SIDED|95.0|-3.74|2.32|||Mixed Models Repeated Measures|||Placebo vs GW823296 60 mg: Week 4||2.32|-3.74|0.6428
72437466|NCT00880048|144388159|SUPERIORITY||Mean Difference (Net)|-0.68||||0.6911|TWO_SIDED|95.0|-4.06|2.7|||Mixed Models Repeated Measures|||Placebo vs GW823296 30 mg: Week 6||2.70|-4.06|0.6911
72437467|NCT00880048|144388159|SUPERIORITY||Odds Ratio (OR)|-0.67||||0.7026|TWO_SIDED|95.0|-4.14|2.8|||Mixed Models Repeated Measures|||Placebo vs GW823296 60 mg: Week 6||2.80|-4.14|0.7026
72437468|NCT00880048|144388160|SUPERIORITY||Mean Difference (Net)|-0.97||||0.1301|TWO_SIDED|95.0|-2.24|0.29|||Mixed Models Repeated Measures|||Placebo vs GW823296 30 mg: Week 1||0.29|-2.24|0.1301
72437469|NCT00880048|144388160|SUPERIORITY||Mean Difference (Net)|0.47||||0.4644|TWO_SIDED|95.0|-0.79|1.73|||Mixed Models Repeated Measures|||Placebo vs GW823296 60 mg: Week 1||1.73|-0.79|0.4644
72437470|NCT00880048|144388160|SUPERIORITY||Mean Difference (Net)|-0.76||||0.3382|TWO_SIDED|95.0|-2.33|0.8|||Mixed Models Repeated Measures|||Placebo vs GW823296 30 mg: Week 2||0.80|-2.33|0.3382
72437471|NCT00880048|144388160|SUPERIORITY||Mean Difference (Net)|0.94||||0.241|TWO_SIDED|95.0|-0.63|2.51|||Mixed Models Repeated Measures|||Placebo vs GW823296 60 mg: Week 2||2.51|-0.63|0.2410
72437472|NCT00880048|144388160|SUPERIORITY||Mean Difference (Net)|-0.98||||0.2768|TWO_SIDED|95.0|-2.75|0.79|||Mixed Models Repeated Measures|||Placebo vs GW823296 30 mg: Week 4||0.79|-2.75|0.2768
72437473|NCT00880048|144388160|SUPERIORITY||Mean Difference (Net)|0.06||||0.9434|TWO_SIDED|95.0|-1.7|1.83|||Mixed Models Repeated Measures|||Placebo vs GW823296 60 mg: Week 4||1.83|-1.70|0.9434
72437474|NCT00880048|144388160|SUPERIORITY||Mean Difference (Net)|-0.55||||0.5796|TWO_SIDED|95.0|-2.49|1.4|||Mixed Models Repeated Measures|||Placebo vs GW823296 30 mg: Week 6||1.40|-2.49|0.5796
72437475|NCT00880048|144388160|SUPERIORITY||Mean Difference (Net)|0.71||||0.4753|TWO_SIDED|95.0|-1.24|2.66|||Mixed Models Repeated Measures|||Placebo vs GW823296 60 mg: Week 6||2.66|-1.24|0.4753
72437476|NCT04141917|144388161|SUPERIORITY||Risk Ratio, log|1.33|||||TWO_SIDED|95.0|0.35|5.02||||||The number of influenza-positive tests was analyzed using a generalized linear mixed model following a Poisson distribution with a log link and robust variance. The model is adjusted for calendar time and an exposure time variable based on shelter capacity. This model includes symptomatic individuals who tested throughout Year 1 of the study (November 15, 2019 - March 31, 2020).||5.02|0.35|
72618807|NCT01049828|144768170|OTHER|The analysis is based on a threshold-free cluster enhancement permutation technique.|||||<|0.01||||||all correlations were transformed into z scores using Fisher's transformation and a t test evaluated group differences.|Fisher Exact|The analysis is based on a threshold-free cluster enhancement permutation technique.||Null hypothesis: Fisher's transform z scores for a seed region were comparable between the control and non-bothered tinnitus groups.||||<0.01
72437477|NCT01184508|144388169|SUPERIORITY_OR_OTHER||Least squares (LS) mean difference (Net)|-1.03||||0.085|TWO_SIDED|90.0|-2.02|-0.05||The comparison between LY2300559 and placebo for the LS mean change from baseline to Month 3 in the number of migraine attacks was conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed-effects model repeated-measures|Fixed effects: pooled investigator, treatment (tx) group, month, tx group\*month, baseline, baseline\*month; Random effect: pts; Repeated effect: month.||||-0.05|-2.02|0.085
72437478|NCT01184508|144388171|SUPERIORITY_OR_OTHER||Least squares (LS) mean difference|1.75||||0.77|TWO_SIDED|90.0|-8.27|11.76||The p-value is for the change from baseline to Month 3 in average duration of photophobia.|Mixed-effects model repeated-measures|Fixed effects: pooled investigator, treatment (tx) group, month, tx group\*month, baseline, baseline\*month; Random effect: pts; Repeated effect: month.||||11.76|-8.27|0.770
72437479|NCT01184508|144388171|SUPERIORITY_OR_OTHER||LS mean difference|7.3||||0.276|TWO_SIDED|90.0|-3.91|18.52||The p-value is for the change from baseline to Month 3 in average duration of phonophobia.|Mixed-effects model repeated-measures|Fixed effects: pooled investigator, tx group, month, tx group\*month, baseline, baseline\*month; Random effect: pts; Repeated effect: month.||||18.52|-3.91|0.276
72437480|NCT01184508|144388171|SUPERIORITY_OR_OTHER||LS mean difference|-2.7||||0.606|TWO_SIDED|90.0|-11.51|6.1||The p-value is for the change from baseline to Month 3 in average duration of nausea.|Mixed-effects model repeated-measures|Fixed effects: pooled investigator, tx group, month, tx group\*month, baseline, baseline\*month; Random effect: pts; Repeated effect: month.||||6.10|-11.51|0.606
72437481|NCT01184508|144388172|SUPERIORITY_OR_OTHER||Least squares (LS) mean difference|-1.57||||0.174|TWO_SIDED|90.0|-3.48|0.34||The p-value is for the mean change from baseline to Month 3 in the number of migraine days.|Mixed-effects model repeated-measures|Fixed effects: pooled investigator, treatment (tx) group, month, tx group\*month, baseline, baseline\*month; Random effect: pts; Repeated effect: month.||||0.34|-3.48|0.174
72437482|NCT01184508|144388175|SUPERIORITY_OR_OTHER||Least squares (LS) mean difference|-0.27||||0.963|TWO_SIDED|90.0|-9.76|9.23||The p-value is for the change from baseline to Week 12 in MSQ restrictive function score.|ANCOVA|Fixed effects: investigator (pooled site), treatment group, visit, treatment group\*visit, baseline and baseline\*visit.||||9.23|-9.76|0.963
72437483|NCT01184508|144388175|SUPERIORITY_OR_OTHER||LS mean difference|-2.17||||0.591|TWO_SIDED|90.0|-8.85|4.5||The p-value is for the change from baseline to Week 12 in MSQ preventive function score.|ANCOVA|Fixed effects: investigator (pooled site), treatment group, visit, treatment group\*visit, baseline and baseline\*visit.||||4.50|-8.85|0.591
72437484|NCT01184508|144388175|SUPERIORITY_OR_OTHER||LS mean difference|1.89||||0.72|TWO_SIDED|90.0|-6.81|10.58||The p-value is for the change from baseline to Week 12 in MSQ emotional function score.|ANCOVA|Fixed effects: investigator (pooled site), treatment group, visit, treatment group\*visit, baseline and baseline\*visit.||||10.58|-6.81|0.720
72437485|NCT01184508|144388176|SUPERIORITY_OR_OTHER||Least squares (LS) mean difference|-0.25||||0.688|TWO_SIDED|90.0|-1.3|0.8||The p-value is for the change from baseline to Week 12 in MIBS-4 overall weighted score.|ANCOVA|Fixed effects: pooled investigator, treatment group, and baseline.||||0.80|-1.30|0.688
72437486|NCT01184508|144388178|SUPERIORITY_OR_OTHER|||||||0.607||95.0||||The p-value is for the percentage of participants using breakthrough medication at Month 3.|Fisher Exact|||||||0.607
72437487|NCT03684265|144388185|EQUIVALENCE|Bioequivalence acceptance range for the ratio of geometric means was 80- 125%|Geometric mean ratio T/R, %|92.74|STANDARD_ERROR_OF_MEAN|8.66|||TWO_SIDED|95.0|89.02|96.62|||||Standard error of the mean is actually intra individual coefficient of variation.|Relative bioavailability comparison of Movalis® capsules (T) with Movalis® tablets (R) for AUC0-t. The analysis of variance (ANOVA) model in the log scale was used. This model included the sequence, period and type of therapy as fixed effects and the effect study subjects grouped within the sequence was considered random||96.62|89.02|
72437488|NCT03684265|144388186|EQUIVALENCE|Bioequivalence acceptance range for the ratio of geometric means was 80- 125%|Geometric mean ratio T/R, %|78.94|STANDARD_ERROR_OF_MEAN|14.57|||TWO_SIDED|90.0|73.7|84.56|||||Standard error of the mean is actually intra individual coefficient of variation.|Relative bioavailability comparison of Movalis® capsules (T) with Movalis® tablets (R) for Cmax. The analysis of variance (ANOVA) model in the log scale was used. This model included the sequence, period and type of therapy as fixed effects and the effect study subjects grouped within the sequence was considered random||84.56|73.70|
72437489|NCT03684265|144388187|EQUIVALENCE|Bioequivalence acceptance range for the ratio of geometric means was 80- 125%|Geometric mean ratio T/R, %|97.04|STANDARD_ERROR_OF_MEAN|9.96|||TWO_SIDED|90.0|92.57|101.72|||||Standard error of the mean is actually intra individual coefficient of variation.|Relative bioavailability comparison of Movalis® capsules (T) with Movalis® tablets (R) for AUC0-∞. The analysis of variance (ANOVA) model in the log scale was used. This model included the sequence, period and type of therapy as fixed effects and the effect study subjects grouped within the sequence was considered random||101.72|92.57|
72437490|NCT00094575|144388232|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.97||||0.81|TWO_SIDED|95.0|0.77|1.22|||Log Rank||The HR was estimated by comparing Endovascular repair arm vs the Open repair arm.|The primary outcome was long-term, all-cause mortality. The sample size would provide 80% power to detect a 25% relative reduction in mortality at a two-sided alpha level of 0.05. The primary comparison was the main effects of Endovascular repair vs Open repair of AAA.||1.22|0.77|0.81
72437491|NCT00094575|144388233|SUPERIORITY_OR_OTHER|||||||0.12|TWO_SIDED||||||Chi-squared|||||||0.12
72437492|NCT00094575|144388234|SUPERIORITY_OR_OTHER|||||||0.81|TWO_SIDED||||||Mixed Models Analysis|||||||0.81
72437493|NCT00094575|144388235|SUPERIORITY_OR_OTHER|||||||0.8|TWO_SIDED||||||Mixed Models Analysis|||||||0.80
72437494|NCT00094575|144388236|SUPERIORITY_OR_OTHER|||||||0.78|TWO_SIDED||||||Mixed Models Analysis|||||||0.78
72618808|NCT04826731|144768189|OTHER|||||||0.374|||||||Wilcoxon (Mann-Whitney)|||Nonparametric testing was utilized due to non-standard distribution and reduced sample size. Comparison between groups was made by Mann-Whitney U testing. Spearman's rho was utilized for correlation analysis. No subgroup analyses were planned for the study.||||0.374
72437495|NCT00094575|144388237|SUPERIORITY_OR_OTHER|||||||0.58|TWO_SIDED||||||Mixed Models Analysis|||Note: Since this is measuring change over time since baseline, values could be below 0.||||0.58
72437496|NCT00094575|144388238|SUPERIORITY_OR_OTHER|||||||0.37|TWO_SIDED||||||Mixed Models Analysis|||||||0.37
72495083|NCT05227690|144519243|SUPERIORITY|Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.|LS Mean Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.089|=|0.716|TWO_SIDED|95.0|-0.21|0.14|||Mixed Model for Repeated Measures (MMRM)||Emraclidine 10 mg - Placebo|Week 2-- Emraclidine 10 mg versus Placebo||0.14|-0.21|=0.7160
72495084|NCT05227690|144519243|SUPERIORITY|Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.|LS Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.1|=|0.6883|TWO_SIDED|95.0|-0.24|0.16|||Mixed Model for Repeated Measures (MMRM)||Emraclidine 30 mg - Placebo|Week 3-- Emraclidine 30 mg versus Placebo||0.16|-0.24|=0.6883
72437497|NCT00094575|144388239|SUPERIORITY_OR_OTHER|||||||0.68|TWO_SIDED||||||Mixed Models Analysis|||||||0.68
72437498|NCT00762619|144388246|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
72437499|NCT00762619|144388247|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
72437500|NCT00762619|144388248|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
72437501|NCT00762619|144388249|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
72437502|NCT00762619|144388250|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
72437503|NCT00762619|144388251|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
72437504|NCT00762619|144388252|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
72618809|NCT04826731|144768190|OTHER|||||||0.635|||||||Wilcoxon (Mann-Whitney)|||Nonparametric testing was utilized due to non-standard distribution and reduced sample size. Comparison between groups was made by Mann-Whitney U testing. Spearman's rho was utilized for correlation analysis. No subgroup analyses were planned for the study.||||0.635
72437505|NCT00762619|144388253|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
72437506|NCT00762619|144388254|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
72437507|NCT00762619|144388255|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
72437508|NCT00762619|144388256|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
72437509|NCT00762619|144388257|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
72437510|NCT00762619|144388258|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
72437511|NCT00762619|144388259|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
72437512|NCT00762619|144388260|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
72437513|NCT00762619|144388261|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
72437514|NCT00762619|144388262|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
72437515|NCT00762619|144388263|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
72437516|NCT00762619|144388264|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
72437517|NCT00762619|144388265|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
72437518|NCT00762619|144388266|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANOVA|||The null hypothesis states that there is no difference between groups.||||0.05
72437519|NCT00762619|144388267|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
72437520|NCT00762619|144388268|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
72437521|NCT00762619|144388269|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
72437522|NCT00762619|144388270|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
72437523|NCT00762619|144388271|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
72437524|NCT00762619|144388272|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
72437525|NCT00762619|144388273|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
72437526|NCT00762619|144388274|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
72437527|NCT00762619|144388275|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
72437528|NCT00762619|144388276|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
72437529|NCT00762619|144388277|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
72558508|NCT00112437|144646492|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-23.98||||0.124|TWO_SIDED|95.0|-53.04|5.09||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance.|Difference in Least Squares Means (back-transformation of difference in log-fraction from baseline).|The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone resorption (s-CTx) compared to placebo over 24 months. The secondary hypothesis states that odanacatib will decrease biochemical indices of bone resorption (s-CTx) over 24 months.||5.09|-53.04|0.124
72437530|NCT00762619|144388278|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
72437531|NCT00762619|144388279|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
72437532|NCT00762619|144388280|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
72437533|NCT00762619|144388281|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
72437534|NCT00762619|144388282|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
72437535|NCT00762619|144388283|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
72618810|NCT06097273|144768196|NON_INFERIORITY|The noninferiority in GM level in the Cohort A1 group compared with that of Cohort A2 group was demonstrated if the lower bound of the 97.5% CI of the GMR was \>0.667.|GMR|1.155|||||TWO_SIDED|97.5|1.086|1.229||||||GMR (Cohort A1 vs Cohort A2) for Influenza A H1N1 Antibody||1.229|1.086|
72437536|NCT00762619|144388284|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
72437537|NCT00762619|144388285|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
72437538|NCT00762619|144388286|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
72437539|NCT00762619|144388287|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
72437540|NCT00762619|144388288|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
72437541|NCT00762619|144388289|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
72437542|NCT00762619|144388290|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
72437543|NCT00762619|144388291|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
72437544|NCT00762619|144388292|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
72437545|NCT00762619|144388293|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
72437546|NCT00762619|144388294|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
72437547|NCT00762619|144388295|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
72437548|NCT00762619|144388296|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
72437549|NCT00762619|144388297|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
72437550|NCT00762619|144388298|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
72437551|NCT00762619|144388299|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
72437552|NCT00762619|144388300|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
72437553|NCT00762619|144388301|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
72437554|NCT00762619|144388302|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
72437555|NCT00762619|144388303|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
72437556|NCT00762619|144388304|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
72437557|NCT00762619|144388305|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
72437558|NCT00762619|144388306|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
72437559|NCT00762619|144388307|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
72437560|NCT00762619|144388308|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
72437561|NCT00762619|144388309|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
72437562|NCT00762619|144388310|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
72437563|NCT00762619|144388311|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
72437564|NCT00762619|144388312|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
72437565|NCT00762619|144388313|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
72504740|NCT03114969|144540498|SUPERIORITY||Odds Ratio (OR)|4.418||||0.006|TWO_SIDED|95.0|1.521|12.834||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Incruse/Anoro Ellipta as comparator.|||12.834|1.521|0.006
72618811|NCT06097273|144768196|SUPERIORITY|The superiority in GM level in the Cohort A1 group compared with that of Cohort A2 group was demonstrated if the lower bound of the 95% confidence interval (CI) of the geometric mean ratio (GMR) was \>1.|GMR|1.155|||||TWO_SIDED|95.0|1.094|1.22||||||GMR (Cohort A1 vs Cohort A2) for Influenza A H1N1 Antibody||1.220|1.094|
72437566|NCT00961636|144388314|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The closed ordered testing procedure was applied to the efficacy hypotheses. If statistical significance was achieved for the primary hypothesis, then the secondary hypothesis was tested. All tests were performed at significance level 0.05.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test was stratified by country||||||<0.001
72437567|NCT00961636|144388315|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The closed ordered testing procedure was applied to the efficacy hypotheses. If statistical significance was achieved for the primary hypothesis, then the secondary hypothesis was tested. All tests were performed at significance level 0.05.|Unconditional Miettinen and Nurminen|||||||<0.001
72437568|NCT02023125|144388335|SUPERIORITY_OR_OTHER||Geometric Least Square Mean Ratio|270.0|||||TWO_SIDED|90.0|228.0|320.0|||||The reported values are percentages of geometric least square mean ratio.|Analysis of variance (ANOVA) was applied to the log-transformed PK parameter and then back transformed to provide geometric least square mean ratios (Treatment B/Treatment A) and confidence intervals (CIs).||320|228|
72437569|NCT02023125|144388336|SUPERIORITY_OR_OTHER||Geometric Least Square Mean Ratio|116.0|||||TWO_SIDED|90.0|103.0|132.0|||||The reported values are percentages of geometric least square mean ratio.|ANOVA was applied to the log-transformed PK parameter and then back transformed to provide geometric least square mean ratios (Alectinib + Esomeprazole/Alectinib Alone) and CIs.||132|103|
72437570|NCT02023125|144388337|SUPERIORITY_OR_OTHER||Geometric Least Square Mean Ratio|292.0|||||TWO_SIDED|90.0|258.0|329.0|||||The reported values are percentages of geometric least square mean ratio.|ANOVA was applied to the log-transformed PK parameter and then back transformed to provide geometric least square mean ratios (Treatment B/Treatment A) and CIs.||329|258|
72437571|NCT02023125|144388338|SUPERIORITY_OR_OTHER||Geometric Least Square Mean Ratio|122.0|||||TWO_SIDED|90.0|109.0|136.0|||||The reported values are percentages of geometric least square mean ratio.|ANOVA was applied to the log-transformed PK parameter and then back transformed to provide geometric least square mean ratios (Alectinib + Esomeprazole/Alectinib Alone) and CIs.||136|109|
72437572|NCT02023125|144388339|SUPERIORITY_OR_OTHER||Geometric Least Square Mean Ratio|377.0|||||TWO_SIDED|90.0|303.0|468.0|||||The reported values are percentages of geometric least square mean ratio.|ANOVA was applied to the log-transformed PK parameter and then back transformed to provide geometric least square mean ratios (Treatment B/Treatment A) and CIs.||468|303|
72437573|NCT02023125|144388340|SUPERIORITY_OR_OTHER||Geometric Least Square Mean Ratio|102.0|||||TWO_SIDED|90.0|87.0|119.0|||||The reported values are percentages of geometric least square mean ratio.|ANOVA was applied to the log-transformed PK parameter and then back transformed to provide geometric least square mean ratios (Alectinib + Esomeprazole/Alectinib Alone) and CIs.||119|87.0|
72437574|NCT02023125|144388341|SUPERIORITY_OR_OTHER||Geometric Least Square Mean Ratio|328.0|||||TWO_SIDED|90.0|276.0|389.0|||||The reported values are percentages of geometric least square mean ratio.|ANOVA was applied to the log-transformed PK parameter and then back transformed to provide geometric least square mean ratios (Treatment B/Treatment A) and CIs.||389|276|
72437575|NCT02023125|144388342|SUPERIORITY_OR_OTHER||Geometric Least Square Mean Ratio|110.0|||||TWO_SIDED|90.0|96.3|126.0|||||The reported values are percentages of geometric least square mean ratio.|ANOVA was applied to the log-transformed PK parameter and then back transformed to provide geometric least square mean ratios (Alectinib + Esomeprazole/Alectinib Alone) and CIs.||126|96.3|
72437576|NCT02023125|144388345|SUPERIORITY_OR_OTHER||Geometric Least Square Mean Ratio|306.0|||||TWO_SIDED|90.0|269.0|348.0|||||The reported values are percentages of geometric least square mean ratio.|ANOVA was applied to the log-transformed PK parameter and then back transformed to provide geometric least square mean ratios (Treatment B/Treatment A) and CIs.||348|269|
72437577|NCT02023125|144388346|SUPERIORITY_OR_OTHER||Geometric Least Square Mean Ratio|122.0|||||TWO_SIDED|90.0|110.0|136.0|||||The reported values are percentages of geometric least square mean ratio.|ANOVA was applied to the log-transformed PK parameter and then back transformed to provide geometric least square mean ratios (Alectinib + Esomeprazole/Alectinib Alone) and CIs.||136|110|
72437578|NCT02023125|144388347|SUPERIORITY_OR_OTHER||Geometric Least Square Mean Ratio|349.0|||||TWO_SIDED|90.0|288.0|422.0|||||The reported values are percentages of geometric least square mean ratio.|ANOVA was applied to the log-transformed PK parameter and then back transformed to provide geometric least square mean ratios (Treatment B/Treatment A) and CIs.||422|288|
72437579|NCT02023125|144388348|SUPERIORITY_OR_OTHER||Geometric Least Square Mean Ratio|109.0|||||TWO_SIDED|90.0|95.3|126.0|||||The reported values are percentages of geometric least square mean ratio.|ANOVA was applied to the log-transformed PK parameter and then back transformed to provide geometric least square mean ratios (Alectinib + Esomeprazole/Alectinib Alone) and CIs.||126|95.3|
72504741|NCT03114969|144540498|SUPERIORITY||Odds Ratio (OR)|4.165||||0.009|TWO_SIDED|95.0|1.425|12.178||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Incruse/Anoro Ellipta as comparator.|||12.178|1.425|0.009
72504742|NCT03114969|144540498|SUPERIORITY||Odds Ratio (OR)|1.209||||0.761|TWO_SIDED|95.0|0.357|4.095||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator.|||4.095|0.357|0.761
72504743|NCT03114969|144540499|SUPERIORITY||Odds Ratio (OR)|2.292||||0.1|TWO_SIDED|95.0|0.853|6.163||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator.|||6.163|0.853|0.100
72385091|NCT02484690|144277997|SUPERIORITY||Difference in Least Squares Means|1.22||||0.2256|TWO_SIDED|80.0|-0.07|2.52||The threshold for statistical significance was an unadjusted 2-sided p-value \<0.2. There was no formal correction for multiple comparisons.|Mixed Model for Repeated Measures|Categorical covariates(cov): RAP/PCV at baseline(BL), treatment group, visit, \& visit by treatment group; Continuous cov: CNV at BL; Unstructured cov|The mean difference was calculated as Arm C minus Arm A.|The null hypothesis (Ho) was that there was no difference in means between the treatment group (Arm C) and the control group (Arm A). The alternative hypothesis (Ha) was that Arm C mean was different from Arm A mean.||2.52|-0.07|0.2256
72385092|NCT02484690|144277997|SUPERIORITY||Difference in Least Squares Means|0.35||||0.7086|TWO_SIDED|80.0|-0.86|1.57||The threshold for statistical significance was an unadjusted 2-sided p-value \<0.2. There was no formal correction for multiple comparisons.|Mixed Model for Repeated Measures|Categorical covariates(cov): RAP/PCV at baseline(BL), treatment group, visit, \& visit by treatment group; Continuous cov: CNV at BL; Unstructured cov|The mean difference was calculated as Arm D minus Arm A.|The null hypothesis (Ho) was that there was no difference in means between the treatment group (Arm D) and the control group (Arm A). The alternative hypothesis (Ha) was that Arm D mean was different from Arm A mean.||1.57|-0.86|0.7086
72385093|NCT02484690|144277999|SUPERIORITY||Difference in Least Squares Means|-0.78||||0.4353|TWO_SIDED|80.0|-2.07|0.51||The threshold for statistical significance was an unadjusted 2-sided p-value \<0.2. There was no formal correction for multiple comparisons.|Mixed Model for Repeated Measures|Categorical covariates(cov): RAP/PCV at baseline(BL), treatment group, visit, \& visit by treatment group; Continuous cov: leak at BL; Unstructured cov|The mean difference was calculated as Arm B minus Arm A.|The null hypothesis (Ho) was that there was no difference in means between the treatment group (Arm B) and the control group (Arm A). The alternative hypothesis (Ha) was that Arm B mean was different from Arm A mean.||0.51|-2.07|0.4353
72385094|NCT02484690|144277999|SUPERIORITY||Difference in Least Squares Means|1.45||||0.1652|TWO_SIDED|80.0|0.11|2.78||The threshold for statistical significance was an unadjusted 2-sided p-value \<0.2. There was no formal correction for multiple comparisons.|Mixed Model for Repeated Measures|Categorical covariates(cov): RAP/PCV at baseline(BL), treatment group, visit, \& visit by treatment group; Continuous cov: leak at BL; Unstructured cov|The mean difference was calculated as Arm C minus Arm A.|The null hypothesis (Ho) was that there was no difference in means between the treatment group (Arm C) and the control group (Arm A). The alternative hypothesis (Ha) was that Arm C mean was different from Arm A mean.||2.78|0.11|0.1652
72385095|NCT02484690|144277999|SUPERIORITY||Difference in Least Squares Means|0.5||||0.61111|TWO_SIDED|80.0|-0.76|1.75||The threshold for statistical significance was an unadjusted 2-sided p-value \<0.2. There was no formal correction for multiple comparisons.|Mixed Model for Repeated Measures|Categorical covariates(cov): RAP/PCV at baseline(BL), treatment group, visit, \& visit by treatment group; Continuous cov: leak at BL; Unstructured cov|The mean difference was calculated as Arm D minus Arm A.|The null hypothesis (Ho) was that there was no difference in means between the treatment group (Arm D) and the control group (Arm A). The alternative hypothesis (Ha) was that Arm D mean was different from Arm A mean.||1.75|-0.76|0.61111
72385096|NCT04916769|144278039|EQUIVALENCE|The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. The ratio of adjusted geometric means and 90% confidence interval were expressed as percentages.|ratio of ajusted geometric means|106.27|||||TWO_SIDED|90.0|97.76|115.53||||||Natural logarithm-transformed bosutinib AUCinf was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Estimates of the adjusted mean differences (Bosutinib 500 mg capsule contents + applesauce 45 mL \[Test\] - Bosutinib 500 mg intact capsule \[Reference\]) and corresponding 90% confidence intervals (CIs) were obtained from the model.||115.53|97.76|
72437580|NCT00430300|144388361|SUPERIORITY_OR_OTHER||NDLM estimate difference|-0.0087||||0.0284|TWO_SIDED|95.0|-0.0943|0.0774|||Bayesian NDLM model|||The Bayesian normal dynamic linear model (NDLM) was used for analysis. 95% credible intervals of the effect size and the posterior distribution were calculated. Posterior distribution was used to calculate a probability (presented as p value) that the dose gives a difference of 0.075 liter from placebo.||0.0774|-0.0943|0.0284
72437581|NCT00430300|144388361|SUPERIORITY_OR_OTHER||NDLM estimate difference|-0.0389||||0.0056|TWO_SIDED|95.0|-0.1299|0.0471|||Bayesian NDLM model|||The Bayesian normal dynamic linear model (NDLM) was used for analysis. 95% credible intervals of the effect size and the posterior distribution were calculated. Posterior distribution was used to calculate a probability (presented as p value) that the dose gives a difference of 0.075 liter from placebo.||0.0471|-0.1299|0.0056
72437582|NCT00430300|144388361|SUPERIORITY_OR_OTHER||NDLM estimate difference|-0.051||||0.0009|TWO_SIDED|95.0|-0.1298|0.029|||Bayesian NDLM model|||The Bayesian normal dynamic linear model (NDLM) was used for analysis. 95% credible intervals of the effect size and the posterior distribution were calculated. Posterior distribution was used to calculate a probability (presented as p value) that the dose gives a difference of 0.075 liter from placebo.||0.0290|-0.1298|0.0009
72437583|NCT00430300|144388362|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.05||0.5849|ONE_SIDED|95.0|-0.09||||Mixed Models Analysis|||Change at Week 2: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.09|0.5849
72437584|NCT00430300|144388362|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.05||0.9737|ONE_SIDED|95.0|-0.17||||Mixed Models Analysis|||Change at Week 2: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.17|0.9737
72437585|NCT00430300|144388362|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.04||0.387|ONE_SIDED|95.0|-0.06||||Mixed Models Analysis|||Change at Week 2: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.06|0.3870
72437586|NCT00430300|144388362|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.06||0.8612|ONE_SIDED|95.0|-0.15||||Mixed Models Analysis|||Change at Week 4: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.15|0.8612
72558509|NCT00112437|144646492|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|22.18|||||TWO_SIDED|95.0|-12.38|56.73|||ANCOVA|Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance.|Difference in Least Squares Means (back-transformation of difference in log-fraction from baseline).|The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone resorption (s-CTx) compared to placebo over 24 months. The secondary hypothesis states that odanacatib will decrease biochemical indices of bone resorption (s-CTx) over 24 months.||56.73|-12.38|
72558510|NCT00112437|144646493|SUPERIORITY_OR_OTHER||Difference in Least Square Means|-16.71||||0.015||95.0|-36.03|2.61||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through a stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure|ANCOVA|Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance.|Difference in Least Square Means (back-transformation of difference in log-fraction from baseline).|The secondary objective was to assess the effect of MK0822 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone resorption (u-DPyr) compared to placebo over 24 months. The secondary hypothesis states that MK0822 will decrease biochemical indices of bone resorption (u-DPyr) over 24 months.||2.61|-36.03|0.015
72618812|NCT06097273|144768196|NON_INFERIORITY|The noninferiority in GM level in the Cohort A1 group compared with that of Cohort A2 group was demonstrated if the lower bound of the 97.5% CI of the GMR was \>0.667.|GMR|1.063|||||TWO_SIDED|97.5|0.999|1.13||||||GMR (Cohort A1 vs Cohort A2) for Influenza A H3N2 Antibody||1.130|0.999|
72385097|NCT04916769|144278039|EQUIVALENCE|The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. The ratio of adjusted geometric means and 90% confidence interval were expressed as percentages.|ratio of adjusted geometric means|101.93|||||TWO_SIDED|90.0|93.97|110.56||||||Natural logarithm-transformed bosutinib AUCinf was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Estimates of the adjusted mean differences (Bosutinib 500 mg capsule contents + yogurt 45 mL \[Test\] - Bosutinib 500 mg intact capsule \[Reference\]) and corresponding 90% CIs were obtained from the model.||110.56|93.97|
72385098|NCT04916769|144278040|EQUIVALENCE|The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. The ratio of adjusted geometric means and 90% confidence interval were expressed as percentages.|ratio of adjusted geometric means|96.82|||||TWO_SIDED|90.0|86.37|108.53||||||Natural logarithm-transformed bosutinib Cmax was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Estimates of the adjusted mean differences (Bosutinib 500 mg capsule contents + applesauce 45 mL \[Test\] - Bosutinib 500 mg intact capsule \[Reference\]) and corresponding 90% CIs were obtained from the model.||108.53|86.37|
72385099|NCT04916769|144278040|EQUIVALENCE|The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. The ratio of adjusted geometric means and 90% confidence interval were expressed as percentages.|ratio of adjusted geometric means|95.39|||||TWO_SIDED|90.0|85.34|106.61||||||Natural logarithm-transformed bosutinib Cmax was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Estimates of the adjusted mean differences (Bosutinib 500 mg capsule contents + yogurt 45 mL \[Test\] - Bosutinib 500 mg intact capsule \[Reference\]) and corresponding 90% CIs were obtained from the model.||106.61|85.34|
72385100|NCT04916769|144278041|EQUIVALENCE|The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. The ratio of adjusted geometric means and 90% confidence interval were expressed as percentages.|ratio of adjusted geometric means|106.23|||||TWO_SIDED|90.0|97.54|115.68||||||Natural logarithm-transformed bosutinib AUClast was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Estimates of the adjusted mean differences (Bosutinib 500 mg capsule contents + applesauce 45 mL \[Test\] - Bosutinib 500 mg intact capsule \[Reference\]) and corresponding 90% CIs were obtained from the model.||115.68|97.54|
72385101|NCT04916769|144278041|EQUIVALENCE|The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. The ratio of adjusted geometric means and 90% confidence interval were expressed as percentages.|ratio of adjusted geometric means|102.08|||||TWO_SIDED|90.0|93.95|110.91||||||Natural logarithm-transformed bosutinib AUClast was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Estimates of the adjusted mean differences (Bosutinib 500 mg capsule contents + yogurt 45 mL \[Test\] - Bosutinib 500 mg intact capsule \[Reference\]) and corresponding 90% CIs were obtained from the model.||110.91|93.95|
72385102|NCT01555983|144278072|SUPERIORITY_OR_OTHER||Cochran-Armitage trend tes|0.0001|||<|0.05|TWO_SIDED||||||Mixed Models Analysis|||The number needed to treat (NNT) to achieve 30% pain reduction during the 8-hour period was 4 (95% CI: 2.1-25.3) for the lower dose vs. placebo, and 3 (95% CI: 1.6-4.2) for the higher dose versus placebo.||||<.05
72385103|NCT05027464|144278085|SUPERIORITY||Odds Ratio (OR)|1.249||||0.202|TWO_SIDED|95.0|0.888|1.759||Not adjusted for multiple comparisons; a priori threshold was P \< 0.05.|Regression, Logistic|Patient demographics were fixed effects, and randomization units with clinics nested within randomization units were random effects.|An odds ratio above one indicates favoring the intervention arm over the usual care arm.|Generalized linear mixed model to account for patient demographics and hierarchical levels for clinics nested within VAHCS. Null hypothesis is that both arms perform equivalently in vaccine uptake after a year. Power was based on recruited VAHCSs and at least 1,000 Veterans per clinic. Using two-sided 0.05 type I error rate, 5-20% outcome rate in UC, we have 90% power to detect between a 9.6% and 14.6% difference with a total sample size of 90,000 to 100,000.||1.759|0.888|0.202
72385104|NCT05027464|144278085|SUPERIORITY||Odds Ratio (OR)|1.228||||0.247|TWO_SIDED|95.0|0.867|1.738|||Regression, Logistic|||Sensitivity analysis, same null hypothesis and model as primary analysis but different pool of patients: Not constrained to Veterans with at least one primary care visit||1.738|0.867|0.247
72558511|NCT00112437|144646493|SUPERIORITY_OR_OTHER||Difference in Least Square Means|-8.51||||0.246||95.0|-27.31|10.29||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through a stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure|ANCOVA|Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance.|Difference in Least Square Means (back-transformation of difference in log-fraction from baseline).|The secondary objective was to assess the effect of MK0822 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone resorption (u-DPyr) compared to placebo over 24 months. The secondary hypothesis states that MK0822 will decrease biochemical indices of bone resorption (u-DPyr) over 24 months.||10.29|-27.31|0.246
72558512|NCT00112437|144646493|SUPERIORITY_OR_OTHER||Difference in Least Square Means|-1.79||||||95.0|-22.66|19.08|||ANCOVA|Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance.|Difference in Least Square Means (back-transformation of difference in log-fraction from baseline).|The secondary objective was to assess the effect of MK0822 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone resorption (u-DPyr) compared to placebo over 24 months. The secondary hypothesis states that MK0822 will decrease biochemical indices of bone resorption (u-DPyr) over 24 months.||19.08|-22.66|
72385105|NCT05027464|144278085|SUPERIORITY||Odds Ratio (OR)|1.263||||0.455|TWO_SIDED|95.0|0.684|2.334|||Regression, Logistic|||Sensitivity analysis; same model and null hypothesis but reassigning small clinics to their parent VAHCS facility, small meaning \< 100 participants. This data set uses the primary analysis data set with the primary visit constraint.||2.334|0.684|0.455
72385106|NCT05027464|144278085|SUPERIORITY||Odds Ratio (OR)|1.26||||0.364|TWO_SIDED|95.0|0.765|2.075|||Regression, Logistic|||Sensitivity Analysis: same model and null hypothesis as primary outcome but the source of vaccination records omits Medicare claims data. The primary data source had included Medicare claims data on vaccination records as a supplement to the VA data.||2.075|0.765|0.364
72385107|NCT05027464|144278085|SUPERIORITY||Odds Ratio (OR)|1.268||||0.168|TWO_SIDED|95.0|0.904|1.778|||Regression, Logistic|||"Sensitivity Analysis: same model and null hypothesis as primary analysis model but the source of data is supplemented by state level registries, named IZ Gateway, which was deployed summer of 2023 where Veteran records of vaccination could be updated at the VA from external vaccination facilities if the Veteran entered the VA in the same state as that vaccination facility. The primary analysis data contains Medicare claims data in this analysis, too."||1.778|0.904|0.168
72385108|NCT05027464|144278086|SUPERIORITY||Odds Ratio (OR)|0.993||||0.976|TWO_SIDED|95.0|0.643|1.535||P \< 0.05 and no multiple comparison adjustment|Regression, Logistic|We adjusted for patient demographics as fixed effects and randomization units and associated clinics as a three-level random effect.|An odds ratio above one indicates favoring the intervention arm over the usual care arm.|Power calculation is similar to the calculation for the primary outcome. Null hypothesis is described in the outcome comparison related to this statistical analysis plan.||1.535|0.643|.976
72385109|NCT05027464|144278086|SUPERIORITY||Odds Ratio (OR)|0.978||||0.893|TWO_SIDED|95.0|0.702|1.361|||Regression, Logistic|GLMM||Sensitivity analysis, same null hypothesis and model as primary analysis but different pool of patients: Not constrained to Veterans with at least one primary care visit||1.361|0.702|0.893
72385110|NCT05027464|144278086|SUPERIORITY||Odds Ratio (OR)|0.961||||0.863|TWO_SIDED|95.0|0.613|1.507|||Regression, Logistic|GLMM||Sensitivity Analysis: same model and null hypothesis as primary outcome but the source of vaccination records omits Medicare claims data. The primary data source had included Medicare claims data on vaccination records as a supplement to the VA data.||1.507|0.613|0.863
72385111|NCT05027464|144278086|SUPERIORITY||Odds Ratio (OR)|1.011||||0.963|TWO_SIDED|95.0|0.636|1.607|||Regression, Logistic|GLMM||"Sensitivity Analysis: same model and null hypothesis as primary analysis model but the source of data is supplemented by state level registries, named IZ Gateway, which was deployed summer of 2023 where Veteran records of vaccination could be updated at the VA from external vaccination facilities if the Veteran entered the VA in the same state as that vaccination facility. The primary analysis data contains Medicare claims data in this analysis, too."||1.607|0.636|0.963
72385112|NCT05027464|144278087|SUPERIORITY||Odds Ratio (OR)|1.191||||0.395|TWO_SIDED|95.0|0.796|1.781||Threshold: P \< 0.05; not adjusted for multiple comparisons|Regression, Logistic|Generalized linear mixed modeling adjusted for baseline covariates and hierarchical levels for randomization units and clinics within them.|Odds ratio in favor of intervention arm (MI) has values higher than 1.|No power calculation for this exploratory outcome. Null hypothesis is that both arms will have equal uptake rates of the COVID-19 Booster vaccination during the study period.||1.781|0.796|0.395
72385113|NCT05027464|144278088|SUPERIORITY||Odds Ratio (OR)|1.128||||0.119|TWO_SIDED|95.0|0.97|1.311||P-value was not adjusted for multiple comparisons and the p-value threshold was \< 0.05.|Regression, Logistic|Generalized linear mixed model adjusting for baseline covariates and flu vaccine in prior year, with hierarchical random effects for ran. unit/site|Odds ratio in favor of novel intervention arm has values higher than 1|Null hypothesis is that both study arms will have equal rates of flu vaccination uptake during the study period. No power calculation since this outcome is exploratory.||1.311|0.97|0.119
72385114|NCT05203289|144278106|OTHER||Ratio of geometric means (%)|101.88|||||TWO_SIDED|90.0|93.31|111.23|||||"The estimated parameter was the adjusted geometric mean ratios (%) of BI 695501: (40 mg/0.4 mL (T))/(40 mg/0.8 mL (R)).~Geometric standard error= 105.455."|The statistical model used for the analysis of the primary endpoints was an analysis of covariance (ANCOVA) model on the logarithmic scale. The PK endpoints were log-transformed (natural logarithm) prior to fitting the ANCOVA model. This model included effects accounting for the following sources of variation: 'treatment', 'location of trial medication injection' and 'baseline body weight' (continuous).||111.23|93.31|
72385115|NCT05203289|144278107|OTHER||Ratio of geometric means (%)|105.38|||||TWO_SIDED|90.0|95.06|116.81|||||"The estimated parameter was the adjusted geometric mean ratios (%) of BI 695501: (40 mg/0.4 mL (T))/(40 mg/0.8 mL (R)).~Geometric standard error= 106.431."|The statistical model used for the analysis of the primary endpoints was an analysis of covariance (ANCOVA) model on the logarithmic scale. The PK endpoints were log-transformed (natural logarithm) prior to fitting the ANCOVA model. This model included effects accounting for the following sources of variation: 'treatment', 'location of trial medication injection' and 'baseline body weight' (continuous).||116.81|95.06|
72437587|NCT00430300|144388362|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.05||0.7499|ONE_SIDED|95.0|-0.13||||Mixed Models Analysis|||Change at Week 4: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.13|0.7499
72437588|NCT00430300|144388362|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.05||0.5134|ONE_SIDED|95.0|-0.08||||Mixed Models Analysis|||Change at Week 4: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.08|0.5134
72437589|NCT00430300|144388362|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.08|STANDARD_ERROR_OF_MEAN|0.07||0.1244|ONE_SIDED|95.0|-0.04||||Mixed Models Analysis|||Change at Week 8: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.04|0.1244
72437590|NCT00430300|144388362|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.07||0.53|ONE_SIDED|95.0|-0.12||||Mixed Models Analysis|||Change at Week 8: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.12|0.5300
72437591|NCT00430300|144388362|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.06||0.055|ONE_SIDED|95.0|0.0||||Mixed Models Analysis|||Change at Week 8: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.00|0.0550
72437592|NCT00430300|144388363|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.07||0.7444|ONE_SIDED|95.0|-0.16||||Mixed Models Analysis|||Change at Week 2: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.16|0.7444
72437593|NCT00430300|144388363|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.07||0.9134|ONE_SIDED|95.0|-0.21||||Mixed Models Analysis|||Change at Week 2: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.21|0.9134
72437594|NCT00430300|144388363|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.06||0.6841|ONE_SIDED|95.0|-0.13||||Mixed Models Analysis|||Change at Week 2: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.13|0.6841
72437595|NCT00430300|144388363|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.07||0.9283|ONE_SIDED|95.0|-0.23||||Mixed Models Analysis|||Change at Week 4: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.23|0.9283
72437596|NCT00430300|144388363|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.04|STANDARD_ERROR_OF_MEAN|0.07||0.2991|ONE_SIDED|95.0|-0.08||||Mixed Models Analysis|||Change at Week 4: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.08|0.2991
72437597|NCT00430300|144388363|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.06||0.7403|ONE_SIDED|95.0|-0.15||||Mixed Models Analysis|||Change at Week 4: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.15|0.7403
72437598|NCT00430300|144388363|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.03|STANDARD_ERROR_OF_MEAN|0.09||0.3499|ONE_SIDED|95.0|-0.11||||Mixed Models Analysis|||Change at Week 6: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.11|0.3499
72437599|NCT00430300|144388363|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.05|STANDARD_ERROR_OF_MEAN|0.08||0.2734|ONE_SIDED|95.0|-0.09||||Mixed Models Analysis|||Change at Week 6: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.09|0.2734
72558513|NCT00112437|144646493|SUPERIORITY_OR_OTHER||Difference in Least Square Means|21.74||||||95.0|-1.32|44.81|||ANCOVA|Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance.|Difference in Least Square Means (back-transformation of difference in log-fraction from baseline).|The secondary objective was to assess the effect of MK0822 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone resorption (u-DPyr) compared to placebo over 24 months. The secondary hypothesis states that MK0822 will decrease biochemical indices of bone resorption (u-DPyr) over 24 months.||44.81|-1.32|
72618813|NCT06097273|144768196|SUPERIORITY|The superiority in GM level in the Cohort A1 group compared with that of Cohort A2 group was demonstrated if the lower bound of the 95% CI of the GMR was \>1.|GMR|1.063|||||TWO_SIDED|95.0|1.007|1.122||||||GMR (Cohort A1 vs Cohort A2) for Influenza A H3N2 Antibody||1.122|1.007|
72437600|NCT00430300|144388363|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.07||0.5806|ONE_SIDED|95.0|-0.14||||Mixed Models Analysis|||Change at Week 6: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.14|0.5806
72437601|NCT00430300|144388363|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.18|STANDARD_ERROR_OF_MEAN|0.11||0.054|ONE_SIDED|95.0|0.0||||Mixed Models Analysis|||Change at Week 8: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.00|0.0540
72437602|NCT00430300|144388363|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.07|STANDARD_ERROR_OF_MEAN|0.1||0.2616|ONE_SIDED|95.0|-0.11||||Mixed Models Analysis|||Change at Week 8: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.11|0.2616
72437603|NCT00430300|144388363|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.14|STANDARD_ERROR_OF_MEAN|0.09||0.0724|ONE_SIDED|95.0|-0.02||||Mixed Models Analysis|||Change at Week 8: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.02|0.0724
72495085|NCT05227690|144519243|SUPERIORITY|Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.|LS Mean Difference|0.05|STANDARD_ERROR_OF_MEAN|0.1|=|0.5973|TWO_SIDED|95.0|-0.14|0.25|||Mixed Model for Repeated Measures (MMRM)||Emraclidine 10 mg - Placebo|Week 3-- Emraclidine 10 mg versus Placebo||0.25|-0.14|=0.5973
72495086|NCT05227690|144519243|SUPERIORITY|Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.|LS Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.11|=|0.1392|TWO_SIDED|95.0|-0.38|0.05|||Mixed Model for Repeated Measures (MMRM)||Emraclidine 30 mg - Placebo|Week 4-- Emraclidine 30 mg versus Placebo||0.05|-0.38|=0.1392
72495087|NCT05227690|144519243|SUPERIORITY|Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.|LS Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.111|=|0.9421|TWO_SIDED|95.0|-0.21|0.23|||Mixed Model for Repeated Measures (MMRM)||Emraclidine 10 mg - Placebo|Week 4-- Emraclidine 10 mg versus Placebo||0.23|-0.21|=0.9421
72495088|NCT05227690|144519243|SUPERIORITY|Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.|LS Mean Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.116|=|0.5431|TWO_SIDED|95.0|-0.3|0.16|||Mixed Model for Repeated Measures (MMRM)||Emraclidine 30 mg - Placebo|Week 5-- Emraclidine 30 mg versus Placebo||0.16|-0.30|=0.5431
72495089|NCT05227690|144519243|SUPERIORITY|Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.|LS Mean Difference|0.03|STANDARD_ERROR_OF_MEAN|0.117|=|0.816|TWO_SIDED|95.0|-0.2|0.26|||Mixed Model for Repeated Measures (MMRM)||Emraclidine 10 mg - Placebo|Week 5-- Emraclidine 10 mg versus Placebo||0.26|-0.20|=0.8160
72495090|NCT05227690|144519243|SUPERIORITY|Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.|LS Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.124|=|0.2534|TWO_SIDED|95.0|-0.39|0.1|||Mixed Model for Repeated Measures (MMRM)||Emraclidine 30 mg - Placebo|Week 6-- Emraclidine 30 mg versus Placebo||0.10|-0.39|=0.2534
72495091|NCT05227690|144519243|SUPERIORITY|Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.|LS Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.125|=|0.6774|TWO_SIDED|95.0|-0.3|0.19|||Mixed Model for Repeated Measures (MMRM)||Emraclidine 10 mg - Placebo|Week 6-- Emraclidine 10 mg versus Placebo||0.19|-0.30|=0.6774
72495092|NCT05227690|144519244|SUPERIORITY|Odds ratio, 95% confidence interval, and p-value were from a logistic regression with treatment group, geographic region and Baseline value as a covariate.|Odds Ratio|1.9|||=|0.0904|TWO_SIDED|95.0|0.9|3.99|||Regression, Logistic|||Emraclidine 30 mg versus Placebo||3.99|0.90|=0.0904
72495093|NCT05227690|144519244|SUPERIORITY|Odds ratio, 95% confidence interval, and p-value were from a logistic regression with treatment group, geographic region and Baseline value as a covariate.|Odds Ratio|1.96|||=|0.0756|TWO_SIDED|95.0|0.93|4.13|||Regression, Logistic|||Emraclidine 10 mg versus Placebo||4.13|0.93|=0.0756
72558514|NCT00112437|144646494|SUPERIORITY_OR_OTHER||Difference in Least Square Means|-16.64||||0.002||95.0|-28.84|-4.44||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through a stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure|ANCOVA|Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance.|Difference in Least Square Means (back-transformation of difference in log-fractions from baseline)|The secondary objective was to assess the effect of MK0822 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone formation (s-BSAP) compared to placebo over 24 months.||-4.44|-28.84|0.002
72558515|NCT00112437|144646494|SUPERIORITY_OR_OTHER||Difference in Least Square Means|7.24||||0.852||95.0|-5.73|20.21||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through a stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure|ANCOVA|Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance.|Difference in Least Square Means (back-transformation of difference in log-fractions from baseline)|The secondary objective was to assess the effect of MK0822 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone formation (s-BSAP) compared to placebo over 24 months.||20.21|-5.73|0.852
72558516|NCT00112437|144646494|SUPERIORITY_OR_OTHER||Difference in Least Square Means|-0.39||||||95.0|-13.69|12.92|||ANCOVA|Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance.|Difference in Least Square Means (back-transformation of difference in log-fractions from baseline)|The secondary objective was to assess the effect of MK0822 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone formation (s-BSAP) compared to placebo over 24 months.||12.92|-13.69|
72618814|NCT06097273|144768196|NON_INFERIORITY|The noninferiority in GM level in the Cohort B1 group compared with that of Cohort B2 group was demonstrated if the lower bound of the 97.5% CI of the GMR was \>0.667.|GMR|1.414|||||TWO_SIDED|97.5|1.322|1.513||||||GMR (Cohort B1 vs Cohort B2) for Influenza A H1N1 Antibody||1.513|1.322|
72437604|NCT00430300|144388364|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.1||0.9362|ONE_SIDED|95.0|-0.32||||Mixed Models Analysis|||Change at Week 2: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.32|0.9362
72437605|NCT00430300|144388364|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.1||0.9469|ONE_SIDED|95.0|-0.33||||Mixed Models Analysis|||Change at Week 2: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.33|0.9469
72437606|NCT00430300|144388364|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.09||0.9153|ONE_SIDED|95.0|-0.27||||Mixed Models Analysis|||Change at Week 2: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.27|0.9153
72437607|NCT00430300|144388364|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.1||0.9686|ONE_SIDED|95.0|-0.36||||Mixed Models Analysis|||Change at Week 4: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.36|0.9686
72437608|NCT00430300|144388364|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.1||0.1548|ONE_SIDED|95.0|-0.06||||Mixed Models Analysis|||Change at Week 4: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.06|0.1548
72437609|NCT00430300|144388364|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.09||0.7973|ONE_SIDED|95.0|-0.22||||Mixed Models Analysis|||Change at Week 4: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.22|0.7973
72437610|NCT00430300|144388364|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.11||0.6348|ONE_SIDED|95.0|-0.22||||Mixed Models Analysis|||Change at Week 6: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.22|0.6348
72437611|NCT00430300|144388364|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.1||0.5742|ONE_SIDED|95.0|-0.19||||Mixed Models Analysis|||Change at Week 6: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.19|0.5742
72437612|NCT00430300|144388364|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.09||0.6719|ONE_SIDED|95.0|-0.19||||Mixed Models Analysis|||Change at Week 6: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.19|0.6719
72437613|NCT00430300|144388364|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.18|STANDARD_ERROR_OF_MEAN|0.13||0.0881|ONE_SIDED|95.0|-0.04||||Mixed Models Analysis|||Change at Week 8: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.04|0.0881
72437614|NCT00430300|144388364|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.07|STANDARD_ERROR_OF_MEAN|0.12||0.2772|ONE_SIDED|95.0|-0.13||||Mixed Models Analysis|||Change at Week 8: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.13|0.2772
72437615|NCT00430300|144388364|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.12|STANDARD_ERROR_OF_MEAN|0.11||0.1363|ONE_SIDED|95.0|-0.06||||Mixed Models Analysis|||Change at Week 8: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.06|0.1363
72437616|NCT00430300|144388365|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.14|STANDARD_ERROR_OF_MEAN|0.1||0.0938|ONE_SIDED|95.0|-0.03||||Mixed Models Analysis|||Change at Week 2: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.03|0.0938
72437617|NCT00430300|144388365|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.08|STANDARD_ERROR_OF_MEAN|0.1||0.2149|ONE_SIDED|95.0|-0.09||||Mixed Models Analysis|||Change at Week 2: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.09|0.2149
72495094|NCT05227690|144519251|SUPERIORITY|Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.|LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.05|=|0.2418|TWO_SIDED|95.0|0.0|0.2|||Mixed Model for Repeated Measures (MMRM)||Emraclidine 30 mg - Placebo|Week 3-- Emraclidine 30 mg versus Placebo||0.2|0.0|=0.2418
72558517|NCT00112437|144646494|SUPERIORITY_OR_OTHER||Difference in Least Square Means|36.79||||||95.0|21.19|52.38|||ANCOVA|Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance.|Difference in Least Square Means (back-transformation of difference in log-fractions from baseline)|The secondary objective was to assess the effect of MK0822 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone formation (s-BSAP) compared to placebo over 24 months.||52.38|21.19|
72558518|NCT00112437|144646495|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-21.49||||0.011|TWO_SIDED|95.0|-39.55|-3.43||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through a stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure|ANCOVA|Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance.|Difference in Least Squares Means (back-transformation of difference in log-fraction from baseline)|The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone formation (s-P1NP) compared to placebo over 24 months.||-3.43|-39.55|0.011
72495095|NCT05227690|144519251|SUPERIORITY|Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.|LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.05|=|0.572|TWO_SIDED|95.0|-0.1|0.1|||Mixed Model for Repeated Measures (MMRM)||Emraclidine 10 mg - Placebo|Week 3-- Emraclidine 10 mg versus Placebo||0.1|-0.1|=0.5720
72437618|NCT00430300|144388365|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.09|STANDARD_ERROR_OF_MEAN|0.09||0.1682|ONE_SIDED|95.0|-0.06||||Mixed Models Analysis|||Change at Week 2: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.06|0.1682
72437619|NCT00430300|144388365|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.1||0.4492|ONE_SIDED|95.0|-0.16||||Mixed Models Analysis|||Change at Week 4: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.16|0.4492
72437620|NCT00430300|144388365|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.07|STANDARD_ERROR_OF_MEAN|0.1||0.2539|ONE_SIDED|95.0|-0.1||||Mixed Models Analysis|||Change at Week 4: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.10|0.2539
72437621|NCT00430300|144388365|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.09||0.8168|ONE_SIDED|95.0|-0.22||||Mixed Models Analysis|||Change at Week 4: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.22|0.8168
72437622|NCT00430300|144388365|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.05|STANDARD_ERROR_OF_MEAN|0.11||0.3248|ONE_SIDED|95.0|-0.13||||Mixed Models Analysis|||Change at Week 6: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.13|0.3248
72437623|NCT00430300|144388365|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.05|STANDARD_ERROR_OF_MEAN|0.11||0.3148|ONE_SIDED|95.0|-0.13||||Mixed Models Analysis|||Change at Week 6: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.13|0.3148
72437624|NCT00430300|144388365|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.09||0.6563|ONE_SIDED|95.0|-0.2||||Mixed Models Analysis|||Change at Week 6: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.20|0.6563
72437625|NCT00430300|144388365|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.12|STANDARD_ERROR_OF_MEAN|0.12||0.1735|ONE_SIDED|95.0|-0.09||||Mixed Models Analysis|||Change at Week 8: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.09|0.1735
72495096|NCT05227690|144519251|SUPERIORITY|Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.|LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.06|=|0.7459|TWO_SIDED|95.0|-0.1|0.1|||Mixed Model for Repeated Measures (MMRM)||Emraclidine 30 mg - Placebo|Week 6-- Emraclidine 30 mg versus Placebo||0.1|-0.1|=0.7459
72495097|NCT05227690|144519251|SUPERIORITY|Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.|LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.06|=|0.6729|TWO_SIDED|95.0|-0.1|0.1|||Mixed Model for Repeated Measures (MMRM)||Emraclidine 10 mg - Placebo|Week 6-- Emraclidine 10 mg versus Placebo||0.1|-0.1|=0.6729
72495098|NCT05227690|144519252|SUPERIORITY|Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.|LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.06|=|0.3783|TWO_SIDED|95.0|-0.1|0.2|||Mixed Model for Repeated Measures (MMRM)||Emraclidine 30 mg - Placebo|Week 3-- Emraclidine 30 mg versus Placebo||0.2|-0.1|=0.3783
72437626|NCT00430300|144388365|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.14|STANDARD_ERROR_OF_MEAN|0.12||0.1237|ONE_SIDED|95.0|-0.06||||Mixed Models Analysis|||Change at Week 8: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.06|0.1237
72437627|NCT00430300|144388365|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.11||0.6113|ONE_SIDED|95.0|-0.21||||Mixed Models Analysis|||Change at Week 8: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.21|0.6113
72437628|NCT00430300|144388366|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.05||0.5549|ONE_SIDED|95.0|-0.09||||Mixed Models Analysis|||Change at Week 2: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.09|0.5549
72618815|NCT06097273|144768196|SUPERIORITY|The superiority in GM level in the Cohort B1 group compared with that of Cohort B2 group was demonstrated if the lower bound of the 95% CI of the GMR was \>1.|GMR|1.414|||||TWO_SIDED|95.0|1.333|1.5||||||GMR (Cohort B1 vs Cohort B2) for Influenza A H1N1 Antibody||1.500|1.333|
72437629|NCT00430300|144388366|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.05||0.988|ONE_SIDED|95.0|-0.2||||Mixed Models Analysis|||Change at Week 2: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.20|0.9880
72437630|NCT00430300|144388366|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.04||0.8572|ONE_SIDED|95.0|-0.12||||Mixed Models Analysis|||Change at Week 2: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.12|0.8572
72385116|NCT05203289|144278108|OTHER||Ratio of geometric means (%)|91.29|||||TWO_SIDED|90.0|84.38|98.76|||||"The estimated parameter was the adjusted geometric mean ratios (%) of BI 695501: (40 mg/0.4 mL (T))/(40 mg/0.8 mL (R)).~Geometric standard error= 104.874."|The statistical model used for the analysis of the primary endpoints was an analysis of covariance (ANCOVA) model on the logarithmic scale. The PK endpoints were log-transformed (natural logarithm) prior to fitting the ANCOVA model. This model included effects accounting for the following sources of variation: 'treatment', 'location of trial medication injection' and 'baseline body weight' (continuous).||98.76|84.38|
72385117|NCT03270644|144278109|OTHER||Difference of LSMeans|-5.45|||||TWO_SIDED|90.0|-7.27|-3.64||||||Mean hourly HR was evaluated in a linear mixed-effects model with a fixed effect for treatment and a random effect for subject.||-3.64|-7.27|
72385118|NCT03270644|144278110|OTHER||Ratio of Geometric LSMeans|0.884|||||TWO_SIDED|90.0|0.832|0.939||||||Log-transformed PK parameters were evaluated in a linear mixed-effects model with a fixed effect for treatment and a random effect for subject.||0.939|0.832|
72385119|NCT03270644|144278111|OTHER||Ratio of Geometric LSMeans|0.958|||||TWO_SIDED|90.0|0.917|1.0||||||Ratio of geometric LSMeans of Cmax used a mixed-effects repeated measures model adjusted for fixed effects for treatment, time point, time point by treatment, and random effect for subjects.||1.00|0.917|
72385120|NCT03270644|144278112|OTHER||Ratio of Geometric LSMeans|1.01|||||TWO_SIDED|90.0|0.967|1.04||||||Log-transformed PK parameters were evaluated in a linear mixed-effects model with a fixed effect for treatment and a random effect for subject.||1.04|0.967|
72385121|NCT03270644|144278113|OTHER||Ratio of Geometric LSMeans|0.999|||||TWO_SIDED|90.0|0.967|1.03||||||Log-transformed PK parameters were evaluated in a linear mixed-effects model with a fixed effect for treatment and a random effect for subject.||1.03|0.967|
72385122|NCT03270644|144278114|OTHER||Difference of LSMeans|-3.51|||||TWO_SIDED|90.0|-6.39|-0.64||||||PR interval was evaluated in a linear mixed-effects model with a fixed effect for treatment and a random effect for subject.||-0.64|-6.39|
72385123|NCT03270644|144278115|OTHER||Difference of LSMeans|5.57|||||TWO_SIDED|90.0|3.57|7.57||||||Systolic blood pressure was evaluated in a linear mixed-effects model with a fixed effect for treatment and a random effect for subject.||7.57|3.57|
72385124|NCT03270644|144278116|OTHER||Difference of LSMeans|3.47|||||TWO_SIDED|90.0|1.99|4.95||||||Diastolic blood pressure was evaluated in a linear mixed-effects model with a fixed effect for treatment and a random effect for subject.||4.95|1.99|
72385125|NCT02024529|144278122|SUPERIORITY|||||||0.97||||||Adjusted for baseline WOMAC score|ANCOVA|||||||0.97
72385126|NCT02024529|144278123|SUPERIORITY|||||||0.75||||||Adjusted for baseline WOMAC score|ANCOVA|||||||0.75
72385127|NCT02024529|144278124|SUPERIORITY|||||||0.18|||||||ANCOVA|Adjusted for baseline WOMAC Score.||||||0.18
72385128|NCT02024529|144278125|SUPERIORITY|||||||0.81|||||||ANCOVA|Adjusted for baseline WOMAC Score.||||||0.81
72385129|NCT01426438|144278127|SUPERIORITY_OR_OTHER|||||||0.28|TWO_SIDED||||||Sign test|Stratified exact Wilcoxon signed rank test. Stratified by screening HDL-C level and statin use within 90 days prior to study entry.||||||0.28
72504744|NCT03114969|144540499|SUPERIORITY||Odds Ratio (OR)|2.642||||0.051|TWO_SIDED|95.0|0.994|7.022||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator.|||7.022|0.994|0.051
72618816|NCT06097273|144768196|NON_INFERIORITY|The noninferiority in GM level in the Cohort B1 group compared with that of Cohort B2 group was demonstrated if the lower bound of the 97.5% CI of the GMR was \>0.667.|GMR|1.38|||||TWO_SIDED|97.5|1.3|1.465||||||GMR (Cohort B1 vs Cohort B2) for Influenza A H3N2 Antibody||1.465|1.300|
72385130|NCT01426438|144278127|SUPERIORITY_OR_OTHER|||||||0.19|TWO_SIDED||||||Sign test|Stratified exact Wilcoxon signed rank test. Stratified by screening HDL-C level and statin use within 90 days prior to study entry.||||||0.19
72385131|NCT01147640|144278143|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-12.4|||||TWO_SIDED|||||||||||||
72385132|NCT01147640|144278144|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-5.2|||||TWO_SIDED|95.0||||||||||||
72385133|NCT00986830|144278198|SUPERIORITY||||||<|0.0001||||||Paired t-tests were used to calculate the p-values and evaluate whether the change in outcomes from baseline to follow-up were statistically different from zero. A p value of \<0.05 was considered statistically significant.|t-test, 2 sided||||A reduction in SNOT-20 score of 0.8 or more is considered clinically meaningful.|||<0.0001
72385134|NCT00986830|144278199|SUPERIORITY||||||<|0.0001||||||Paired t-tests were used to calculate the p-values and evaluate whether the change in outcomes from baseline to follow-up were statistically different from zero. A p value \<0.05 is considered statistically significant.|t-test, 2 sided|||||||<0.0001
72385135|NCT00986830|144278200|SUPERIORITY||||||<|0.0001||||||Paired t-tests were used to calculate the p-values and evaluate whether the change in outcomes from baseline to follow-up were statistically different from zero. A p value \<0.05 is considered statistically significant.|t-test, 2 sided|||||||<0.0001
72385136|NCT00986830|144278201|SUPERIORITY||||||<|0.0001||||||Paired t-tests were used to calculate the p-values and evaluate whether the change in outcomes from baseline to follow-up were statistically different from zero. A p value \<0.05 is considered statistically significant.|t-test, 2 sided|||||||<0.0001
72385137|NCT00986830|144278202|SUPERIORITY||||||<|0.0001||||||Paired t-tests were used to calculate the p-values and evaluate whether the change in outcomes from baseline to follow-up were statistically different from zero. A p value \<0.05 is considered statistically significant.|t-test, 2 sided|||||||<0.0001
72385138|NCT00986830|144278203|SUPERIORITY|||||||0.009||||||Paired t-tests were used to calculate the p-values and evaluate whether the change in outcomes from baseline to follow-up were statistically different from zero. A p value \<0.05 indicates statistical significance.|t-test, 2 sided|||||||0.009
72504745|NCT03114969|144540500|SUPERIORITY||Odds Ratio (OR)|3.995|||<|0.001|TWO_SIDED|95.0|1.808|8.829||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta+\[Relvar Ellipta+LAMA\] as comparator.|||8.829|1.808|<0.001
72504746|NCT03114969|144540500|SUPERIORITY||Odds Ratio (OR)|2.181||||0.069|TWO_SIDED|95.0|0.94|5.059||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta+\[Relvar Ellipta+LAMA\] as comparator.|||5.059|0.940|0.069
72437631|NCT00430300|144388366|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.05||0.8402|ONE_SIDED|95.0|-0.14||||Mixed Models Analysis|||Change at Week 4: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.14|0.8402
72385139|NCT00986830|144278204|SUPERIORITY|||||||0.292||||||Paired t-tests were used to calculate the p-values and evaluate whether the change in outcomes from baseline to follow-up were statistically different from zero. A p value \<0.05 indicates statistical significance.|t-test, 2 sided|||||||0.292
72385140|NCT00986830|144278205|SUPERIORITY||||||<|0.0001||||||Paired t-tests were used to calculate the p-values and evaluate whether the change in outcomes from baseline to follow-up were statistically different from zero. A p value \<0.05 indicates statistical significance.|t-test, 2 sided|||||||<0.0001
72385141|NCT02038881|144278228|OTHER||GMT Ratio (Group 1 / Group 2) at Week 4|0.851|||||TWO_SIDED|95.0|0.258|2.8||||||||2.800|0.258|
72385142|NCT02038881|144278228|OTHER||GMT Ratio (Group 1 / Group 2) at Week 6|0.653|||||TWO_SIDED|95.0|0.319|1.333||||||||1.333|0.319|
72385143|NCT02038881|144278228|OTHER||GMT Ratio (Group 1 / Group 2) at Week 30|1.126|||||TWO_SIDED|95.0|0.291|4.352||||||||4.352|0.291|
72385144|NCT02038881|144278228|OTHER||GMT Ratio (Group 1 / Group 2) at Week 56|0.916|||||TWO_SIDED|95.0|0.22|3.819||||||||3.819|0.220|
72385145|NCT02038881|144278228|OTHER||GMT Ratio (Group 3 / Group 1) at Week 4|1.045|||||TWO_SIDED|95.0|0.292|3.741||||||||3.741|0.292|
72385146|NCT02038881|144278228|OTHER||GMT Ratio (Group 3 / Group 1) at Week 6|1.315|||||TWO_SIDED|95.0|0.598|2.892||||||||2.892|0.598|
72385147|NCT02038881|144278229|OTHER||GMT Ratio (Group 1+3 [pooled] / Group 2)|0.762|||||TWO_SIDED|95.0|0.385|1.507||||||||1.507|0.385|
72385148|NCT02038881|144278230|OTHER||GMT Ratio (Group 1 [W6]/ Group 3 [W14)|0.347|||||TWO_SIDED|95.0|0.2|0.603||||||||0.603|0.200|
72385149|NCT02038881|144278230|OTHER||GMT ratio (Group 2 [W6]/ Group 3 [W14])|0.532|||||TWO_SIDED|95.0|0.285|0.992||||||||0.992|0.285|
72385150|NCT02038881|144278231|OTHER||GMT Ratio (Group 3 [W38]/ Group 1 [W30])|4.138|||||TWO_SIDED|95.0|1.241|13.793||||||||13.793|1.241|
72385151|NCT02038881|144278231|OTHER||GMT Ratio (Group 3 [W64]/ Group 1 [W56])|4.608|||||TWO_SIDED|95.0|1.365|15.558||||||||15.558|1.365|
72385152|NCT02038881|144278231|OTHER||GMT Ratio (Group 2 [W30]/ Group 3 [W38])|0.215|||||TWO_SIDED|95.0|0.066|0.699||||||||0.699|0.066|
72385153|NCT02038881|144278231|OTHER||GMT Ratio (Group 2 [W56]/ Group 3 [W64])|0.237|||||TWO_SIDED|95.0|0.072|0.782||||||||0.782|0.072|
72385154|NCT02038881|144278232|OTHER||GMT Ratio (Group 1 / Group 2) at Week 4|0.823|||||TWO_SIDED|95.0|0.333|2.038||||||||2.038|0.333|
72385155|NCT02038881|144278232|OTHER||GMT Ratio (Group 1 / Group 2) at Week 6|0.787|||||TWO_SIDED|95.0|0.41|1.508||||||||1.508|0.410|
72385156|NCT02038881|144278232|OTHER||GMT Ratio (Group 1 / Group 2) at Week 30|0.535|||||TWO_SIDED|95.0|0.187|1.536||||||||1.536|0.187|
72385157|NCT02038881|144278232|OTHER||GMT Ratio (Group 1 / Group 2) at Week 56|0.59|||||TWO_SIDED|95.0|0.203|1.716||||||||1.716|0.203|
72385158|NCT02038881|144278232|OTHER||GMT Ratio (Group 3 / Group 1) at Week 4|2.557|||||TWO_SIDED|95.0|0.972|6.731||||||||6.731|0.972|
72385159|NCT02038881|144278232|OTHER||GMT Ratio (Group 3 / Group 1) at Week 6|1.215|||||TWO_SIDED|95.0|0.612|2.412||||||||2.412|0.612|
72385160|NCT02038881|144278233|OTHER||GMT Ratio (Group 1+3 [pooled] / Group 2)|0.878|||||TWO_SIDED|95.0|0.48|1.606||||||||1.606|0.480|
72385161|NCT02038881|144278234|OTHER||GMT ratio (Group 1 [W6]/ Group 3 [W14)|0.281|||||TWO_SIDED|95.0|0.146|0.542||||||||0.542|0.146|
72385162|NCT02038881|144278234|OTHER||GMT ratio (Group 2 [W6]/ Group 3 [W14])|0.357|||||TWO_SIDED|95.0|0.178|0.718||||||||0.718|0.178|
72385163|NCT02038881|144278235|OTHER||GMT Ratio (Group 3 [W38]/ Group 1 [W30])|6.727|||||TWO_SIDED|95.0|2.493|18.15||||||||18.150|2.493|
72385164|NCT02038881|144278235|OTHER||GMT Ratio (Group 3 [W64]/ Group 1 [W56])|7.275|||||TWO_SIDED|95.0|2.693|19.649||||||||19.649|2.693|
72385165|NCT02038881|144278235|OTHER||GMT Ratio (Group 2 [W30]/ Group 3 [W38])|0.278|||||TWO_SIDED|95.0|0.115|0.672||||||||0.672|0.115|
72385166|NCT02038881|144278235|OTHER||GMT Ratio (Group 2 [W56]/ Group 3 [W64])|0.233|||||TWO_SIDED|95.0|0.1|0.541||||||||0.541|0.100|
72385167|NCT02038881|144278236|OTHER||Diff in SC rate (Gr 1 - Gr 2) at Week 4|-7.6|||||TWO_SIDED|95.0|-34.1|17.9||||||||17.9|-34.1|
72385168|NCT02038881|144278236|OTHER||Diff in SC rate (Gr 1 - Gr 2) at Week 6|0.0|||||TWO_SIDED|95.0|-16.8|16.3||||||||16.3|-16.8|
72385169|NCT02038881|144278236|OTHER||Diff in SC rate (Gr 1 - Gr 2) at Week 30|5.1|||||TWO_SIDED|95.0|-24.5|32.6||||||||32.6|-24.5|
72385170|NCT02038881|144278236|OTHER||Diff in SC rate (Gr 1 - Gr 2) at Week 56|-1.5|||||TWO_SIDED|95.0|-31.5|29.2||||||||29.2|-31.5|
72385171|NCT02038881|144278236|OTHER||Diff in SC rate (Gr 3 - Gr 1) at Week 4|-5.8|||||TWO_SIDED|95.0|-32.8|22.2||||||||22.2|-32.8|
72385172|NCT02038881|144278236|OTHER||Diff in SC rate (Gr 3 - Gr 1) at Week 6|-7.7|||||TWO_SIDED|95.0|-25.1|10.1||||||||10.1|-25.1|
72385173|NCT02038881|144278237|OTHER||Difference in seroconversion rates (%)|-4.3|||||TWO_SIDED|95.0|-15.2|11.6||||||||11.6|-15.2|
72385174|NCT02038881|144278238|OTHER||Diff in SC rate (Gr 1 [W6] - Gr 3 [W14])|0.0|||||TWO_SIDED|95.0|-17.1|13.4||||||||13.4|-17.1|
72385175|NCT02038881|144278238|OTHER||Diff in SC rate (Gr 2 [W6] - Gr 3 [W14])|0.0|||||TWO_SIDED|95.0|-16.2|13.4||||||||13.4|-16.2|
72385176|NCT02038881|144278239|OTHER||Diff in SC rate (Gr3 [W38] - Gr1 [W30])|5.6|||||TWO_SIDED|95.0|-19.6|33.0||||||||33.0|-19.6|
72385177|NCT02038881|144278239|OTHER||Diff in SC rate (Gr3 [W64] - Gr1 [W56])|16.7|||||TWO_SIDED|95.0|-11.0|44.4||||||||44.4|-11.0|
72385178|NCT02038881|144278239|OTHER||Diff in SC rate (Gr2 [W30] - Gr3 [W38])|-10.6|||||TWO_SIDED|95.0|-35.6|14.3||||||||14.3|-35.6|
72385179|NCT02038881|144278239|OTHER||Diff in SC rate (Gr2 [W56] - Gr3 [W64])|-15.2|||||TWO_SIDED|95.0|-40.5|10.5||||||||10.5|-40.5|
72385180|NCT02038881|144278240|OTHER||Diff in SC rate (Gr 1 - Gr 2) at Week 4|-9.6|||||TWO_SIDED|95.0|-38.4|20.3||||||||20.3|-38.4|
72385181|NCT02038881|144278240|OTHER||Diff in SC rate (Gr 1 - Gr 2) at Week 6|0.0|||||TWO_SIDED|95.0|-16.8|16.3||||||||16.3|-16.8|
72385182|NCT02038881|144278240|OTHER||Diff in SC rate (Gr 1 - Gr 2) at Week 30|-9.6|||||TWO_SIDED|95.0|-38.4|17.6||||||||17.6|-38.4|
72385183|NCT02038881|144278240|OTHER||Diff in SC rate (Gr 1 - Gr 2) at Week 56|-6.1|||||TWO_SIDED|95.0|-35.6|23.7||||||||23.7|-35.6|
72385184|NCT02038881|144278240|OTHER||Diff in SC rate (Gr 3 - Gr 1) at Week 4|20.8|||||TWO_SIDED|95.0|-7.7|47.8||||||||47.8|-7.7|
72385185|NCT02038881|144278240|OTHER||Diff in SC rate (Gr 3 - Gr 1) at Week 6|-3.8|||||TWO_SIDED|95.0|-20.5|13.4||||||||13.4|-20.5|
72385186|NCT02038881|144278241|OTHER||Difference in seroconversion rates (%)|-2.2|||||TWO_SIDED|95.0|-12.0|13.2||||||||13.2|-12.0|
72385187|NCT02038881|144278242|OTHER||Diff in SC rate (Gr 1 [W6] - Gr 3 [W14])|0.0|||||TWO_SIDED|95.0|-17.1|13.4||||||||13.4|-17.1|
72558519|NCT00112437|144646495|SUPERIORITY_OR_OTHER||Difference in Least square means|13.31||||0.618||95.0|-7.1|33.71||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through a stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure|ANCOVA|Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance.|Difference in Least square means (back-transformation of difference in log-fraction from baseline)|The secondary objective was to assess the effect of MK0822 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone formation (s-P1NP) compared to placebo over 24 months.||33.71|-7.10|0.618
72495099|NCT05227690|144519252|SUPERIORITY|Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.|LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.06|=|0.2242|TWO_SIDED|95.0|-0.2|0.0|||Mixed Model for Repeated Measures (MMRM)||Emraclidine 10 mg - Placebo|Week 3-- Emraclidine 10 mg versus Placebo||0.0|-0.2|=0.2242
72618817|NCT06097273|144768196|SUPERIORITY|The superiority in GM level in the Cohort B1 group compared with that of Cohort B2 group was demonstrated if the lower bound of the 95% CI of the GMR was \>1.|GMR|1.38|||||TWO_SIDED|95.0|1.31|1.454||||||GMR (Cohort B1 vs Cohort B2) for Influenza A H3N2 Antibody||1.454|1.310|
72437632|NCT00430300|144388366|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.05||0.6562|ONE_SIDED|95.0|-0.1||||Mixed Models Analysis|||Change at Week 4: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.10|0.6562
72437633|NCT00430300|144388366|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.04||0.5632|ONE_SIDED|95.0|-0.08||||Mixed Models Analysis|||Change at Week 4: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.08|0.5632
72437634|NCT00430300|144388366|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.07||0.637|ONE_SIDED|95.0|-0.13||||Mixed Models Analysis|||Change at Week 6: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.13|0.6370
72437635|NCT00430300|144388366|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.06||0.4686|ONE_SIDED|95.0|-0.1||||Mixed Models Analysis|||Change at Week 6: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.10|0.4686
72437636|NCT00430300|144388366|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.06||0.6164|ONE_SIDED|95.0|-0.11||||Mixed Models Analysis|||Change at Week 6: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.11|0.6164
72385188|NCT02038881|144278242|OTHER||Diff in SC rate (Gr 2 [W6] - Gr 3 [W14])|0.0|||||TWO_SIDED|95.0|-16.2|13.4||||||||13.4|-16.2|
72385189|NCT02038881|144278243|OTHER||Diff in SC rate (Gr3 [W38] - Gr1 [W30])|19.4|||||TWO_SIDED|95.0|-4.5|45.8||||||||45.8|-4.5|
72385190|NCT02038881|144278243|OTHER||Diff in SC rate (Gr3 [W64] - Gr1 [W56])|29.2|||||TWO_SIDED|95.0|5.8|55.4||||||||55.4|5.8|
72385191|NCT02038881|144278243|OTHER||Diff in SC rate (Gr2 [W30] - Gr3 [W38])|-9.8|||||TWO_SIDED|95.0|-33.0|11.7||||||||11.7|-33.0|
72437637|NCT00430300|144388374|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.4|STANDARD_ERROR_OF_MEAN|0.6||0.9885|ONE_SIDED|95.0|-2.4||||Mixed Models Analysis|||TDI at Week 2: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-2.4|0.9885
72437638|NCT00430300|144388374|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.6||0.8055|ONE_SIDED|95.0|-1.5||||Mixed Models Analysis|||TDI at Week 2: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-1.5|0.8055
72618818|NCT06097273|144768196|NON_INFERIORITY|The noninferiority in GM level in the Cohort A1 group compared with that of Cohort A2 group was demonstrated if the lower bound of the 97.5% CI of the GMR was \>0.667.|GMR|1.118|||||TWO_SIDED|97.5|1.063|1.175||||||GMR (Cohort A1 vs Cohort A2) for Influenza B Victoria-lineage Antibody||1.175|1.063|
72385192|NCT02038881|144278243|OTHER||Diff in SC rate (Gr2 [W56] - Gr3 [W64])|-23.1|||||TWO_SIDED|95.0|-46.7|-1.0||||||||-1.0|-46.7|
72385193|NCT01453725|144278254|SUPERIORITY_OR_OTHER||Difference in Percent vs Placebo|31.2|||<|0.0001|TWO_SIDED|95.0|17.5|43.6||Stratification factors: Baseline evidence of sacroiliitis on magnetic resonance imaging (MRI) and Screening C-reactive protein (CRP) level|Stratified Miettinen and Nurminen Method|||||43.6|17.5|<0.0001
72385194|NCT01453725|144278255|SUPERIORITY_OR_OTHER||Difference in Percent vs Placebo|33.8|||<|0.0001|TWO_SIDED|95.0|20.4|46.1||Stratification factors: Baseline evidence of sacroiliitis on MRI and Screening CRP level|Stratified Miettinen and Nurminen Method|||||46.1|20.4|<0.0001
72385195|NCT01453725|144278256|SUPERIORITY_OR_OTHER||Difference in Percent vs Placebo|28.0|||<|0.0001|TWO_SIDED|95.0|14.4|40.6||Stratification factors: Baseline evidence of sacroiliitis on MRI and Screening CRP level|Stratified Miettinen and Nurminen Method|||||40.6|14.4|<0.0001
72385196|NCT01453725|144278257|SUPERIORITY_OR_OTHER||Difference in Percent vs Placebo|15.2||||0.0136|TWO_SIDED|95.0|3.2|27.1||Stratification factors: Baseline evidence of sacroiliitis on MRI and Screening CRP level|Stratified Miettinen and Nurminen Method|||||27.1|3.2|0.0136
72385197|NCT01453725|144278258|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mann-Whitney Test|||||||<0.0001
72385198|NCT00178633|144278296|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||ANOVA|||||||<.0001
72385199|NCT01254292|144278334|SUPERIORITY_OR_OTHER||single proportion|82.1|||||TWO_SIDED|95.0|77.1|86.5|||||Clopper Pearson Confidence Interval|||86.5|77.1|
72385200|NCT01254292|144278334|SUPERIORITY_OR_OTHER||single proportion|81.9|||||TWO_SIDED|95.0|76.7|86.4|||||Clopper Pearson Confidence Interval|||86.4|76.7|
72385201|NCT04981392|144278369|SUPERIORITY||Cox Proportional Hazard|0.49|STANDARD_ERROR_OF_MEAN|0.18||0.0066|TWO_SIDED||||||Difference in adjusted % vaccinated|||||||0.0066
72385202|NCT04981392|144278370|SUPERIORITY||Cox Proportional Hazard|0.83|STANDARD_ERROR_OF_MEAN|0.3||0.0058|TWO_SIDED||||||Difference in adjusted % vaccinated|||||||0.0058
72558520|NCT00112437|144646495|SUPERIORITY_OR_OTHER||Difference in Least square means|7.77|||||TWO_SIDED|95.0|-13.46|29.01|||ANCOVA|Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance.|Difference in Least Squares Means (back-transformation of difference in log-fraction from baseline)|The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone formation (s-P1NP) compared to placebo over 24 months.||29.01|-13.46|
72437639|NCT00430300|144388374|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|0.5||0.9759|ONE_SIDED|95.0|-2.0||||Mixed Models Analysis|||TDI at Week 2: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-2.0|0.9759
72618819|NCT06097273|144768196|SUPERIORITY|The superiority in GM level in the Cohort A1 group compared with that of Cohort A2 group was demonstrated if the lower bound of the 95% CI of the GMR was \>1.|GMR|1.118|||||TWO_SIDED|95.0|1.07|1.167||||||GMR (Cohort A1 vs Cohort A2) for Influenza B Victoria-lineage Antibody||1.167|1.070|
72558521|NCT00112437|144646495|SUPERIORITY_OR_OTHER||Difference in Least Square Means|49.23|||||TWO_SIDED|95.0|23.86|74.59|||ANCOVA|Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance.|Difference in Least Square Means (back-transformation of difference in log-fraction from baseline)|The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone formation (s-P1NP) compared to placebo over 24 months.||74.59|23.86|
72385203|NCT00471146|144278402|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.014||||0.5436|TWO_SIDED|95.0|0.786|1.309||One-sided log-rank test at alpha = 0.025 significance level was used.|Log Rank|||Differences in OS between treatment arms was analyzed by 1-sided log rank test, stratified for extent of disease (locally advanced cancer versus metastatic cancer).||1.309|0.786|0.5436
72385204|NCT00471146|144278403|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.006||||0.5203|TWO_SIDED|95.0|0.779|1.298||One-sided log-rank test at alpha = 0.025 significance level was used.The p-value was not adjusted for multiple testing.|Log Rank|||Differences in PFS between treatment arms was analyzed by 1-sided log rank test, stratified for extent of disease (locally advanced cancer versus metastatic cancer).||1.298|0.779|0.5203
72385205|NCT00471146|144278404|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|3.2||||0.038|TWO_SIDED|95.0|1.0|10.1|||Cochran-Mantel-Haenszel|||Differences in OR between treatment arms was analyzed by 1-sided Cochran-Mantel-Haenszel (CMH) test, stratified for extent of disease (locally advanced cancer versus metastatic cancer).||10.1|1.0|0.038
72385206|NCT03800173|144278422|OTHER||Slope|0.982|||||TWO_SIDED|90.0|0.868|1.096||||||A model with In-transformed dose (dose continuous) as a fixed effect \& subject as a random effect was applied to In-transformed Cmax. Dose proportionality was assessed by restricted max likelihood using SAS PROC MIXED. The mean slope was estimated from the power model \& the corresponding 90% CI calculated. Although there was no formal statistical hypothesis tested for this secondary objective, there was evidence for dose proportionality if the 90% CI of the fixed slope for In-dose contained 1.||1.096|0.868|
72385207|NCT03800173|144278423|OTHER||Slope|1.0|||||TWO_SIDED|90.0|0.872|1.128||||||A model with In-transformed dose (dose continuous) as a fixed effect \& subject as a random effect was applied to In-transformed AUC0-inf Dose proportionality was assessed by restricted max likelihood using SAS PROC MIXED. The mean slope was estimated from the power model \& the corresponding 90% CI calculated. Although there was no formal statistical hypothesis tested for this secondary objective, there was evidence for dose proportionality if the 90% CI of the fixed slope for In-dose contained 1||1.128|0.872|
72385208|NCT03800173|144278423|OTHER||Slope|1.086|||||TWO_SIDED|90.0|0.952|1.219||||||A model with In-transformed dose (dose continuous) as a fixed effect \& subject as a random effect was applied to In-transformed AUC0-t. Dose proportionality was assessed by restricted max likelihood using SAS PROC MIXED. The mean slope was estimated from the power model \& the corresponding 90% CI calculated. Although there was no formal statistical hypothesis tested for this secondary objective, there was evidence for dose proportionality if the 90% CI of the fixed slope for In-dose contained 1.||1.219|0.952|
72385209|NCT01011738|144278440|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.349||||0.0022|TWO_SIDED|95.0|1.542|7.271||Multiple logistic regression were run in stepwise procedure with significance level of 0.05 to stay, considering all pre and on-treatment factors identified by univariate logistic regression to be associated with HBsAg clearance 3 yrs post-treatment.|Wald-Chi-Square test|||In HBeAg positive participants, Log10-drop HBsAg at Week 24 was analyzed as the predictor factor of HBsAg clearance at 3 years post-treatment in analysis A.||7.271|1.542|0.0022
72385210|NCT01011738|144278440|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.595||||0.0019|TWO_SIDED|95.0|1.603|8.063||Multiple logistic regression were run in stepwise procedure with significance level of 0.05 to stay, considering all pre and on-treatment factors identified by univariate logistic regression to be associated with HBsAg clearance 3 yrs post-treatment.|Wald-Chi-Square test|||In HBeAg positive participants, Log10-drop HBsAg at Week 24 was analyzed as the predictor factor of HBsAg clearance at 3 years post-treatment in analysis B.||8.063|1.603|0.0019
72385211|NCT01011738|144278440|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.851||||0.0369|TWO_SIDED|95.0|0.732|0.99||Multiple logistic regression were run in stepwise procedure with significance level of 0.05 to stay, considering all pre and on-treatment factors identified by univariate logistic regression to be associated with HBsAg clearance 3 yrs post-treatment.|Wald-Chi-Square test|||In HBeAg positive participants, Weight in kg was analyzed as independent predictor factor of HBsAg clearance at 3 years post-treatment in analysis A.||0.990|0.732|0.0369
72385212|NCT01011738|144278444|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.155||||0.0033|TWO_SIDED|95.0|0.045|0.539||Multiple logistic regression were run in stepwise procedure with significance level of 0.05 to stay, considering all pre and on-treatment factors identified by univariate logistic regression to be associated with HBsAg clearance 3 yrs post-treatment.|Wald-Chi-Square test|||In HBeAg negative participants, HBsAg in log10 IU/mL at Week 24 was analyzed as the predictor factor of HBsAg clearance at 3 years post-treatment in analysis A.||0.539|0.045|0.0033
72385213|NCT01011738|144278444|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.191||||0.0042|TWO_SIDED|95.0|0.062|0.594|||Wald-Chi-Square test|||In HBeAg negative participants, HBsAg in log10 IU/mL at Week 24 was analyzed as the predictor factor of HBsAg clearance at 3 years post-treatment in analysis B.||0.594|0.062|0.0042
72558522|NCT00112437|144646496|SUPERIORITY_OR_OTHER||Difference in Least Square Means|6.45|||||TWO_SIDED|95.0|3.38|9.53||||||In postmenopausal women with osteoporosis assess the time course of resolution of effect on lumbar spine BMD during the 12 month extension following 24 months of treatment with odanacatib once weekly. The primary objective was to assess the resolution of effect, on lumbar spine BMD, for the participants who received odanacatib 50 mg for 3 years compared to those who received odanacatib 50 mg in the 2nd year and switched to placebo for the 3rd year extension.||9.53|3.38|
72558523|NCT00112437|144646497|SUPERIORITY_OR_OTHER||Difference in Least Square Means|6.31|||||TWO_SIDED|95.0|3.44|9.17||||||||9.17|3.44|
72495100|NCT05227690|144519252|SUPERIORITY|Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.|LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.05|=|0.8626|TWO_SIDED|95.0|-0.1|0.1|||Mixed Model for Repeated Measures (MMRM)||Emraclidine 30 mg - Placebo|Week 6-- Emraclidine 30 mg versus Placebo||0.1|-0.1|=0.8626
72495101|NCT05227690|144519252|SUPERIORITY|Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.|LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.05|=|0.6106|TWO_SIDED|95.0|-0.1|0.1|||Mixed Model for Repeated Measures (MMRM)||Emraclidine 10 mg - Placebo|Week 6-- Emraclidine 10 mg versus Placebo||0.1|-0.1|=0.6106
72495102|NCT05227690|144519253|SUPERIORITY|Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.|LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.03|=|0.4219|TWO_SIDED|95.0|0.0|0.1|||Mixed Model for Repeated Measures (MMRM)||Emraclidine 30 mg - Placebo|Week 3-- Emraclidine 30 mg versus Placebo||0.1|0.0|=0.4219
72495103|NCT05227690|144519253|SUPERIORITY|Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.|LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.03|=|0.3933|TWO_SIDED|95.0|0.0|0.1|||Mixed Model for Repeated Measures (MMRM)||Emraclidine 10 mg - Placebo|Week 3-- Emraclidine 10 mg versus Placebo||0.1|0.0|=0.3933
72385214|NCT01011738|144278444|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.528||||0.0149|TWO_SIDED|95.0|1.086|2.15||Multiple logistic regression were run in stepwise procedure with significance level of 0.05 to stay, considering all pre and on-treatment factors identified by univariate logistic regression to be associated with HBsAg clearance 3 yrs post-treatment.|Wald-Chi-Square test|||In HBeAg negative participants, ALT ratio was analysed as the predictor factor of HBsAg clearance at 3 years post-treatment in analysis A.||2.150|1.086|0.0149
72495104|NCT05227690|144519253|SUPERIORITY|Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.|LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.02|=|0.7366|TWO_SIDED|95.0|0.0|0.0|||Mixed Model for Repeated Measures (MMRM)||Emraclidine 30 mg - Placebo|Week 6-- Emraclidine 30 mg versus Placebo||0.0|0.0|=0.7366
72495105|NCT05227690|144519253|SUPERIORITY|Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.|LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.02|=|0.4639|TWO_SIDED|95.0|-0.1|0.0|||Mixed Model for Repeated Measures (MMRM)||Emraclidine 10 mg - Placebo|Week 6-- Emraclidine 10 mg versus Placebo||0.0|-0.1|=0.4639
72495106|NCT04033367|144519254|SUPERIORITY||Least square mean difference|-15.52|||<|0.001|TWO_SIDED|95.0|-24.13|-6.9||Threshold of significance at 0.05.|Mixed Models Analysis||Dupilumab versus Placebo|A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measures are reported and continued when primary outcome measure was statistically significant at two-sided 0.05 level.||-6.90|-24.13|<0.001
72495107|NCT04033367|144519255|SUPERIORITY||Least square mean difference|-27.87|||<|0.001|TWO_SIDED|95.0|-37.96|-17.78||Threshold of significance at 0.05.|Mixed Models Analysis||Dupilumab versus Placebo|A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measures are reported and continued when previous outcome measure was statistically significant at two-sided 0.05 level.||-17.78|-37.96|<0.001
72495108|NCT04033367|144519256|SUPERIORITY||Least square mean difference|-15.06|||<|0.001|TWO_SIDED|95.0|-20.56|-9.56||Threshold of significance at 0.05.|Mixed Models Analysis||Dupilumab versus Placebo|A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measures are reported and continued when previous outcome measure was statistically significant at two-sided 0.05 level.||-9.56|-20.56|<0.001
72558524|NCT00112437|144646498|SUPERIORITY_OR_OTHER||Difference in Least Square Means|2.71|||||TWO_SIDED|95.0|-0.16|5.57||||||||5.57|-0.16|
72558525|NCT00112437|144646499|SUPERIORITY_OR_OTHER||Difference in Least Square Means|8.13|||||TWO_SIDED|95.0|3.8|12.46||||||||12.46|3.80|
72558526|NCT00112437|144646500|SUPERIORITY_OR_OTHER||Difference in Least Square Means|1.46|||||TWO_SIDED|95.0|-1.54|4.46||||||||4.46|-1.54|
72558527|NCT00112437|144646501|SUPERIORITY_OR_OTHER||Difference in Least Square Means|2.47|||||TWO_SIDED|95.0|-0.93|5.88||||||||5.88|-0.93|
72558528|NCT00112437|144646502|SUPERIORITY_OR_OTHER||Difference in Least Square Means|-78.06|||||TWO_SIDED|95.0|-119.2|-36.92||||||||-36.92|-119.20|
72437640|NCT00430300|144388374|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.7||0.4401|ONE_SIDED|95.0|-1.1||||Mixed Models Analysis|||TDI at Week 4: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-1.1|0.4401
72437641|NCT00430300|144388374|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.7||0.5957|ONE_SIDED|95.0|-1.4||||Mixed Models Analysis|||TDI at Week 4: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-1.4|0.5957
72558529|NCT00112437|144646503|SUPERIORITY_OR_OTHER||Difference in Least Square Means|-34.25|||||TWO_SIDED|95.0|-78.7|10.2||||||||10.20|-78.70|
72558530|NCT00112437|144646504|SUPERIORITY_OR_OTHER||Difference in Least Square Means|-39.25|||||TWO_SIDED|95.0|-87.17|8.68||||||||8.68|-87.17|
72558531|NCT00112437|144646505|SUPERIORITY_OR_OTHER||Difference in Least Square Means|16.59|||||TWO_SIDED|95.0|-5.67|38.85||||||||38.85|-5.67|
72558532|NCT00112437|144646506|SUPERIORITY_OR_OTHER||Difference in Least Square Means|-5.43|||||TWO_SIDED|95.0|-42.04|31.18||||||||31.18|-42.04|
72558533|NCT00112437|144646507|SUPERIORITY_OR_OTHER||Difference in Least Square Means|49.1|||||TWO_SIDED|95.0|13.37|84.83||||||||84.83|13.37|
72558534|NCT00112437|144646508|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|209.44|||||TWO_SIDED|95.0|127.14|291.73||||||||291.73|127.14|
72437642|NCT00430300|144388374|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.6||0.8302|ONE_SIDED|95.0|-1.7||||Mixed Models Analysis|||TDI at Week 4: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-1.7|0.8302
72495109|NCT04033367|144519257|SUPERIORITY||Least square mean difference|-2.08|||<|0.001|TWO_SIDED|95.0|-2.97|-1.18||Threshold of significance at 0.05.|Mixed Models Analysis||Dupilumab versus Placebo|A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measures are reported and continued when previous outcome measure was statistically significant at two-sided 0.05 level.||-1.18|-2.97|<0.001
72558535|NCT00199901|144646541|SUPERIORITY||Hazard Ratio (HR)|0.913|||||TWO_SIDED|95.0|0.532|1.568||||||||1.568|0.532|
72558536|NCT00199901|144646543|SUPERIORITY||Hazard Ratio (HR)|0.88|||||TWO_SIDED|95.0|0.532|1.455||||||||1.455|0.532|
72558537|NCT00199901|144646544|SUPERIORITY||Hazard Ratio (HR)|0.911|||||TWO_SIDED|95.0|0.514|1.614||||||||1.614|0.514|
72558538|NCT05776901|144646550|OTHER|Descriptive statistics and measures of central tendency, including mean, median, and standard deviation of the System Usability Scores collected from the baseline and week 3 were computed. Then, a two-sided, paired sample t-test was conducted to evaluate the change in mean System Usability Scores from baseline at week 3.|Mean diff in SUS from baseline at week 3|34.17|STANDARD_ERROR_OF_MEAN|14.49|<|0.05|TWO_SIDED|95.0|-28.04|96.37|||t-test, 2 sided|||||96.37|-28.04|<0.05
72558539|NCT00538031|144646671|OTHER|||||||0.61|||||||Log Rank|||||||0.61
72558540|NCT00538031|144646672|OTHER|||||||0.95|||||||Log Rank|||||||0.95
72558541|NCT01339247|144646678|NON_INFERIORITY_OR_EQUIVALENCE|This is a bioequivalence study. The study was performed to fulfill an official requirement of the Brazilian Regulatory Agency - ANVISA - upon a manufacturing site change.|Ratio T formulation/R formulation|1.0886|||||TWO_SIDED|90.0|1.0011|1.177|||||The ratio between the geometric means of the test (T) and reference (R) formulations was calculated.|||1.1770|1.0011|
72558542|NCT01339247|144646679|NON_INFERIORITY_OR_EQUIVALENCE|This is a bioequivalence study. The study was performed to fulfill an official requirement of the Brazilian Regulatory Agency - ANVISA - upon a manufacturing site change.|Ratio T formulation/R formulation|1.0246|||||TWO_SIDED|90.0|0.9676|1.0849|||||The ratio between the geometric means of the test (T) and reference (R) formulations was calculated.|||1.0849|0.9676|
72558543|NCT01339247|144646680|NON_INFERIORITY_OR_EQUIVALENCE|This is a bioequivalence study. The study was performed to fulfill an official requirement of the Brazilian Regulatory Agency - ANVISA - upon a manufacturing site change.|Ratio T formulation/R formulation|1.0317|||||TWO_SIDED|90.0|0.9716|1.0956|||||The ratio between the geometric means of the test (T) and reference (R) formulations was calculated.|||1.0956|0.9716|
72558544|NCT00985439|144646715|SUPERIORITY_OR_OTHER||Mean Difference (Net)|11.407|STANDARD_ERROR_OF_MEAN|2.643|<|0.001|TWO_SIDED|95.0|6.195|16.619|||ANCOVA|||||16.619|6.195|<0.001
72558545|NCT00841542|144646734|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of Least Squares Means|98.19||||||90.0|94.2|102.34|||||Bioequivalence is established when 90% Confidence Interval falls withing 80 - 125|||102.34|94.20|
72558546|NCT00841542|144646735|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of Least Squares Means|98.86||||||90.0|93.38|104.66|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||104.66|93.38|
72558547|NCT00841542|144646736|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of Least Squares Means|99.22||||||90.0|93.87|104.88|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||104.88|93.87|
72558548|NCT04428307|144646750|SUPERIORITY||Risk Ratio (RR)|1.11|||||TWO_SIDED|95.0|0.61|2.02||||||||2.02|0.61|
72558549|NCT04428307|144646750|SUPERIORITY||Risk Ratio (RR)|0.92|||||TWO_SIDED|95.0|0.49|1.71||||||||1.71|0.49|
72558550|NCT04428307|144646751|SUPERIORITY||Risk Ratio (RR)|1.22|||||TWO_SIDED|95.0|0.83|1.8||||||||1.80|0.83|
72558551|NCT04428307|144646751|SUPERIORITY||Risk Ratio (RR)|1.15|||||TWO_SIDED|95.0|0.81|1.62||||||||1.62|0.81|
72558552|NCT04428307|144646752|SUPERIORITY||Risk Ratio (RR)|0.94|||||TWO_SIDED|95.0|0.8|1.09||||||||1.09|0.80|
72558553|NCT04428307|144646752|SUPERIORITY||Risk Ratio (RR)|0.99|||||TWO_SIDED|95.0|0.85|1.16||||||||1.16|0.85|
72558554|NCT04428307|144646753|SUPERIORITY||Risk Ratio (RR)|1.14|||||TWO_SIDED|95.0|0.75|1.73||||||||1.73|0.75|
72558555|NCT04428307|144646753|SUPERIORITY||Risk Ratio (RR)|1.15|||||TWO_SIDED|95.0|0.77|1.74||||||||1.74|0.77|
72558556|NCT04428307|144646754|SUPERIORITY||Risk Ratio (RR)|1.03|||||TWO_SIDED|95.0|0.95|1.11||||||||1.11|0.95|
72558557|NCT04428307|144646754|SUPERIORITY||Risk Ratio (RR)|0.96|||||TWO_SIDED|95.0|0.89|1.04||||||||1.04|0.89|
72495110|NCT04033367|144519258|SUPERIORITY||Least square mean difference|-3.61|||<|0.001|TWO_SIDED|95.0|-5.68|-1.53||Threshold of significance at 0.05.|Mixed Models Analysis||Dupilumab versus Placebo|A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measures are reported and continued when previous outcome measure was statistically significant at two-sided 0.05.||-1.53|-5.68|<0.001
72495111|NCT04033367|144519259|SUPERIORITY||Least square mean difference|9.97||||0.297|TWO_SIDED|95.0|-8.86|28.79||Threshold of significance at 0.05.|Mixed Models Analysis||Dupilumab versus Placebo|A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measures are reported and continued when previous outcome measure was statistically significant at two-sided 0.05.||28.79|-8.86|0.297
72495112|NCT02723201|144519269|SUPERIORITY_OR_OTHER||LS Mean Difference|0.402|||<|0.001|TWO_SIDED|90.0|0.32|0.505|||ANOVA|||Analysis of variance (ANOVA) was performed on the natural logarithms of Cmax with regimen as the fixed effects and participant as the random effect. The point estimate and 90 percent (%) confidence interval (CI) was obtained by taking the antilog of the difference in the log transformed least square (LS) means and its CI, respectively.||0.505|0.320|<0.001
72495113|NCT02723201|144519269|SUPERIORITY_OR_OTHER||LS Mean Difference|1.216||||0.249|TWO_SIDED|90.0|1.016|1.455|||ANOVA|||ANOVA was performed on the natural logarithms of Cmax with regimen as the fixed effects and participant as the random effect. The point estimate and 90% CI was obtained by taking the antilog of the difference in the log transformed LS means and its CI, respectively.||1.455|1.016|0.249
72495114|NCT02723201|144519269|SUPERIORITY_OR_OTHER||LS Mean Difference|0.055|||<|0.001|TWO_SIDED|90.0|0.041|0.074|||ANOVA|||ANOVA was performed on the natural logarithms of Cmax with regimen as the fixed effects and participant as the random effect. The point estimate and 90% CI was obtained by taking the antilog of the difference in the log transformed LS means and its CI, respectively.||0.074|0.041|<0.001
72495115|NCT02723201|144519269|SUPERIORITY_OR_OTHER||LS Mean Difference|0.685||||0.054|TWO_SIDED|90.0|0.499|0.939|||ANOVA|||ANOVA was performed on the natural logarithms of Cmax with regimen as the fixed effects and participant as the random effect. The point estimate and 90% CI was obtained by taking the antilog of the difference in the log transformed LS means and its CI, respectively.||0.939|0.499|0.054
72495116|NCT02723201|144519271|SUPERIORITY_OR_OTHER||LS Mean Difference|0.648||||0.007|TWO_SIDED|90.0|0.497|0.844|||ANOVA|||ANOVA was performed on the natural logarithms of AUC∞ with regimen as the fixed effects and participant as the random effect. The point estimate and 90% CI was obtained by taking the antilog of the difference in the log transformed LS means and its CI, respectively.||0.844|0.497|0.007
72495117|NCT02723201|144519271|SUPERIORITY_OR_OTHER||LS Mean Difference|1.18||||0.423|TWO_SIDED|90.0|1.088|1.279|||ANOVA|||ANOVA was performed on the natural logarithms of AUC∞ with regimen as the fixed effects and participant as the random effect. The point estimate and 90% CI was obtained by taking the antilog of the difference in the log transformed LS means and its CI, respectively.||1.279|1.088|0.423
72495118|NCT02723201|144519271|SUPERIORITY_OR_OTHER||LS Mean Difference|0.116|||<|0.001|TWO_SIDED|90.0|0.077|0.176|||ANOVA|||ANOVA was performed on the natural logarithms of AUC∞ with regimen as the fixed effects and participant as the random effect. The point estimate and 90% CI was obtained by taking the antilog of the difference in the log transformed LS means and its CI, respectively.||0.176|0.077|<0.001
72558558|NCT00924638|144646756|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|6.4||||0.0006|TWO_SIDED|95.0|1.9|21.7|||Log Rank||A hazard ratio of \> 1 indicates that Continuous Monitoring is superior to Control in detecting AF.|||21.7|1.9|0.0006
72495119|NCT02723201|144519271|SUPERIORITY_OR_OTHER||LS Mean Difference|0.836||||0.037|TWO_SIDED|90.0|0.731|0.957|||ANOVA|||ANOVA was performed on the natural logarithms of AUC∞ with regimen as the fixed effects and participant as the random effect. The point estimate and 90% CI was obtained by taking the antilog of the difference in the log transformed LS means and its CI, respectively.||0.957|0.731|0.037
72495120|NCT02475655|144519338|SUPERIORITY|||||||0.67||||||Not adjusted for multiple comparisons. One-sided 5% alpha.|Fisher Exact|Fisher's Exact Mid P-Value||Null hypothesis: There is no difference between the two arms in the percentage of participants experiencing safety milestones from Entry to Week 5.||||0.67
72495121|NCT02475655|144519341|SUPERIORITY||Mean Difference (Net)|0.85||||0.18|TWO_SIDED|90.0|0.69|1.04||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib geometric mean minus No Study Treatment geometric mean. All values were log10 transformed prior to calculating change and conducting analyses and back transformed for presentation.|Null hypothesis: There is no difference between the two arms in the fold change in Plasma Interleukin 6 (IL-6) from baseline to week 4/5.||1.04|0.69|0.18
72495122|NCT02475655|144519343|SUPERIORITY|||||||0.4||||||Not adjusted for multiple comparisons. One-sided 5% alpha.|Fisher Exact|Fisher's Exact Mid P-Value||Null hypothesis: There is no difference between the two arms in the percentage of participants experiencing safety milestones from Entry to Week 12.||||0.40
72495123|NCT02475655|144519347|SUPERIORITY||Mean Difference (Net)|1.31||||0.7|TWO_SIDED|90.0|-4.27|6.9||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in creatinine clearance from Entry to Week 1/2.||6.90|-4.27|0.70
72495124|NCT02475655|144519347|SUPERIORITY||Mean Difference (Net)|1.61||||0.69|TWO_SIDED|90.0|-5.06|8.29||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in creatinine clearance from Entry to Week 4/5.||8.29|-5.06|0.69
72495125|NCT02475655|144519347|SUPERIORITY||Mean Difference (Net)|6.35||||0.09|TWO_SIDED|90.0|0.16|12.5||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.||Null hypothesis: There is no difference between the two arms in the change in creatinine clearance from Entry to 10/12.||12.5|0.16|0.09
72495126|NCT02475655|144519349|SUPERIORITY||Mean Difference (Net)|-0.02||||0.58|TWO_SIDED|90.0|-0.06|0.03||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in creatinine from Entry to Week 1/2.||0.03|-0.06|0.58
72558559|NCT00924638|144646757|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|7.3|||<|0.0001|TWO_SIDED|95.0|2.6|20.8|||Log Rank||A hazard ratio of \> 1 indicates that Continuous Monitoring is superior to Control in detecting AF.|||20.8|2.6|<0.0001
72558560|NCT00924638|144646758|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.68||||0.25|TWO_SIDED|95.0|0.35|1.32|||Log Rank||A hazard ratio of \< 1 indicates that the incidence rate of recurrent stroke or TIA is lower in the Continuous Monitoring arm compared to the Control arm.|||1.32|0.35|0.25
72385215|NCT00543543|144278455|SUPERIORITY_OR_OTHER||Vaccine efficacy|96.7|||<|0.0001|TWO_SIDED|95.0|80.9|99.8|||Exact test, 1-sided||Vaccine efficacy = 100 \* \[1 - (incidence rate with V503 / incidence rate with Gardasil)\]. The pre-specified success criterion was a lower bound of the 95% confidence interval of observed efficacy of \>25%.|||99.8|80.9|<0.0001
72385216|NCT00543543|144278456|SUPERIORITY_OR_OTHER||Vaccine efficacy|97.4|||||TWO_SIDED|95.0|85.0|99.9|||Exact test, 1-sided||Vaccine efficacy = 100 \* \[1 - (incidence rate with V503 / incidence rate with Gardasil)\]. The pre-specified success criterion was a lower bound of the 95% confidence interval of observed efficacy of \>25%.|||99.9|85.0|
72385217|NCT00543543|144278457|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority required that the lower bound of the two-sided confidence interval (CI) of the GMT ratio was \>0.67|GMT ratio|1.02|||<|0.001|TWO_SIDED|95.0|0.99|1.06|||ANOVA||GMT ratio = GMT (V503) / GMT (Gardasil)|Anti-HPV Type 6||1.06|0.99|<0.001
72385218|NCT00543543|144278457|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority required that the lower bound of the two-sided CI of the GMT ratio was \>0.67|GMT ratio|0.8|||<|0.001|TWO_SIDED|95.0|0.77|0.83|||ANOVA||GMT ratio = GMT (V503) / GMT (Gardasil)|Anti-HPV Type 11||0.83|0.77|<0.001
72385219|NCT00543543|144278457|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority required that the lower bound of the two-sided CI of the GMT ratio was \>0.67|GMT ratio|0.99|||<|0.001|TWO_SIDED|95.0|0.96|1.03|||ANOVA||GMT ratio = GMT (V503) / GMT (Gardasil)|Anti-HPV Type 16||1.03|0.96|<0.001
72385220|NCT00543543|144278457|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority required that the lower bound of the two-sided CI of the GMT ratio was \>0.67|GMT ratio|1.19|||<|0.001|TWO_SIDED|95.0|1.14|1.23|||ANOVA||GMT ratio = GMT (V503) / GMT (Gardasil)|Anti-HPV Type 18||1.23|1.14|<0.001
72385221|NCT00543543|144278464|SUPERIORITY_OR_OTHER||Vaccine efficacy|96.0|||||TWO_SIDED|95.0|94.6|97.1|||||Vaccine efficacy = 100 \* \[1 - (incidence rate with V503 / incidence rate with Gardasil)\]. The pre-specified success criterion was a lower bound of the 95% confidence interval of observed efficacy of \>25%.|||97.1|94.6|
72385222|NCT02586064|144278468|OTHER|||||||0.28|||||||t-test, 1 sided|||Baseline||||0.28
72385223|NCT02586064|144278468|EQUIVALENCE|Confidence interval 95%, equivalence margin \[-7,7\].|Mean Difference (Final Values)|1.52|STANDARD_ERROR_OF_MEAN|1.4|||TWO_SIDED|||||||||||||
72437643|NCT00430300|144388374|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.6|STANDARD_ERROR_OF_MEAN|0.9||0.9657|ONE_SIDED|95.0|-3.1||||Mixed Models Analysis|||TDI at Week 6: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-3.1|0.9657
72437644|NCT00430300|144388374|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.9||0.6378|ONE_SIDED|95.0|-1.7||||Mixed Models Analysis|||TDI at Week 6: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-1.7|0.6378
72385224|NCT02586064|144278468|OTHER|||||||0.87|||||||t-test, 1 sided|||End of Treatment||||0.87
72385225|NCT02586064|144278468|EQUIVALENCE|Confidence interval 95%, equivalence margin \[-7,7\].|Mean Difference (Final Values)|-0.43|STANDARD_ERROR_OF_MEAN|2.57|||TWO_SIDED|||||||||||||
72385226|NCT02586064|144278468|EQUIVALENCE|Equivalence hypothesis was assessed using the confidence intervals for the mean differences compared to margins of equivalence (-7,7). The equivalence hypothesis was examined based on the difference between the amount of change from the baseline to the end of treatment on the CAPS between the two conditions. Confidence interval is -7.0 to 1.9.||||||0.26|||||||t-test, 2 sided|||Change||||0.26
72385227|NCT02586064|144278468|EQUIVALENCE|Confidence interval 95%, equivalence margin \[-7,7\].|Mean Difference (Final Values)|-2.56|STANDARD_ERROR_OF_MEAN|2.25|||TWO_SIDED|||||||||||||
72385228|NCT02586064|144278468|OTHER|||||||0.68|||||||t-test, 1 sided|||3 Month Post Treatment||||0.68
72385229|NCT02586064|144278468|EQUIVALENCE|Confidence interval 95%, equivalence margin \[-7,7\].|Mean Difference (Final Values)|1.3|STANDARD_ERROR_OF_MEAN|3.16|||TWO_SIDED|||||||||||||
72385230|NCT02586064|144278468|OTHER|||||||0.84|||||||t-test, 1 sided|||6 Month Follow Up||||0.84
72385231|NCT02586064|144278468|EQUIVALENCE|Confidence interval 95%, equivalence margin \[-7,7\].|Mean Difference (Final Values)|-0.61|STANDARD_ERROR_OF_MEAN|3.05|||TWO_SIDED|||||||||||||
72558561|NCT00924638|144646759|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.8|||||TWO_SIDED|95.0|2.8|14.8|||||A difference of greater than 0 means that a higher percentage of subjects in the Continuous Monitoring arm were using the OAC drugs at the 12 months visit compared to the Control arm.|||14.8|2.8|
72558562|NCT00924638|144646760|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.4|||||TWO_SIDED|95.0|-2.3|3.1|||||A difference of greater than 0 means that a higher percentage of subjects in the Continuous Monitoring arm were using the anti-arrhythmic drugs at the 12 months visit compared to the Control arm.|||3.1|-2.3|
72385232|NCT02586064|144278469|OTHER|||||||0.36|||||||t-test, 1 sided|One sided 97.5% confidence interval, superiority margin was 0.5||Baseline||||0.36
72385233|NCT02586064|144278469|OTHER|||||||0.34|||||||t-test, 1 sided|One sided 97.5% confidence interval, superiority margin was 0.5||4-Week||||0.34
72385234|NCT02586064|144278469|OTHER|||||||0.43|||||||t-test, 1 sided|One sided 97.5% confidence interval, superiority margin was 0.5||8-Week||||0.43
72385235|NCT02586064|144278469|OTHER|||||||0.09|||||||t-test, 1 sided|One sided 97.5% confidence interval, superiority margin was 0.5||6 Month Post Treatment||||0.09
72385236|NCT02586064|144278469|OTHER|||||||0.41|||||||t-test, 1 sided|One sided 97.5% confidence interval, superiority margin was 0.5||End of Treatment||||0.41
72385237|NCT02586064|144278469|SUPERIORITY|Superiority hypotheses were assessed using the confidence interval for the mean differences (-0.33 to 0.20) compared to margin of superiority (-.05).||||||0.64|||||||t-test, 1 sided|One sided 97.5% confidence interval, superiority margin was 0.5||Change||||0.64
72385238|NCT02586064|144278469|OTHER|||||||0.22|||||||t-test, 1 sided|One sided 97.5% confidence interval, superiority margin was 0.5||3 Month Post Treatment||||0.22
72385239|NCT02586064|144278470|OTHER|||||||0.4|||||||t-test, 1 sided|||Baseline||||0.40
72385240|NCT02586064|144278470|OTHER|||||||0.65|||||||t-test, 1 sided|||End of Treatment||||0.65
72495127|NCT02475655|144519349|SUPERIORITY||Mean Difference (Net)|-0.01||||0.79|TWO_SIDED|90.0|-0.06|0.04||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in creatinine from Entry to Week 4/5.||0.04|-0.06|0.79
72495128|NCT02475655|144519349|SUPERIORITY||Mean Difference (Net)|-0.07||||0.016|TWO_SIDED|90.0|-0.11|-0.02||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in creatinine from Entry to 10/12.||-0.02|-0.11|0.016
72495129|NCT02475655|144519351|SUPERIORITY||Mean Difference (Net)|-679.0||||0.018|TWO_SIDED|90.0|-1146.0|-212.0||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean|Null hypothesis: There is no difference between the two arms in the change in absolute neutrophil count (ANC) from Entry to Week 1/2.||-212|-1146|0.018
72495130|NCT02475655|144519351|SUPERIORITY||Mean Difference (Net)|-651.0||||0.021|TWO_SIDED|90.0|-1110.0|-192.0||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in absolute neutrophil count (ANC) from Entry to Week 4/5.||-192|-1110|0.021
72495131|NCT02475655|144519351|SUPERIORITY||Mean Difference (Net)|33.6||||0.91|TWO_SIDED|90.0|-461.0|528.0||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in absolute neutrophil count (ANC) from Entry to Week 10/12.||528|-461|0.91
72495132|NCT02475655|144519353|SUPERIORITY||Mean Difference (Net)|-0.13||||0.45|TWO_SIDED|90.0|-0.42|0.15||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in hemoglobin from Entry to Week 1/2.||0.15|-0.42|0.45
72495133|NCT02475655|144519353|SUPERIORITY||Mean Difference (Net)|-0.55||||0.005|TWO_SIDED|90.0|-0.87|-0.23||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in hemoglobin from Entry to Week 4/5.||-0.23|-0.87|0.005
72495134|NCT02475655|144519353|SUPERIORITY||Mean Difference (Net)|0.15||||0.75|TWO_SIDED|90.0|-0.65|0.95||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in hemoglobin from Entry to Week 10/12.||0.95|-0.65|0.75
72495135|NCT02475655|144519355|SUPERIORITY||Mean Difference (Net)|37754.0|||<|0.001|TWO_SIDED|90.0|19609.0|55898.0||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in platelet values from Entry to Week 1/2.||55898|19609|<0.001
72495136|NCT02475655|144519355|SUPERIORITY||Mean Difference (Net)|27832.0||||0.012|TWO_SIDED|90.0|9849.0|45815.0||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in platelet values from Entry to Week 4/5.||45815|9849|0.012
72495137|NCT02475655|144519355|SUPERIORITY||Mean Difference (Net)|5376.0||||0.52|TWO_SIDED|90.0|-8592.0|19344.0||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in platelet values from Entry to Week 10/12.||19344|-8592|0.52
72495138|NCT02475655|144519357|SUPERIORITY||Mean Difference (Net)|4.96||||0.05|TWO_SIDED|90.0|0.78|9.14||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in Aspartate Aminotransferase (AST) (SGOT) values from Entry to Week 1/2.||9.14|0.78|0.05
72558563|NCT00924638|144646761|SUPERIORITY_OR_OTHER|||||||0.11|||||||t-test, 2 sided|||||||0.11
72495139|NCT02475655|144519357|SUPERIORITY||Mean Difference (Net)|8.15|||<|0.001|TWO_SIDED|90.0|4.47|11.8||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in Aspartate Aminotransferase (AST) (SGOT) values from Entry to Week 4/5.||11.8|4.47|<0.001
72495140|NCT02475655|144519357|SUPERIORITY||Mean Difference (Net)|3.95||||0.025|TWO_SIDED|90.0|1.08|6.81||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in Aspartate Aminotransferase (AST) (SGOT) values from Entry to Week 10/12.||6.81|1.08|0.025
72495141|NCT02475655|144519359|SUPERIORITY||Mean Difference (Net)|4.9||||0.02|TWO_SIDED|90.0|1.46|8.33||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in Alanine Aminotransferase (ALT) (SGPT) values from Entry to Week 1/2.||8.33|1.46|0.020
72558564|NCT00924638|144646762|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.37||||0.33|TWO_SIDED|95.0|0.73|2.6|||Log Rank||A hazard ratio of \< 1 indicates that the incidence rate of cardiovascular or stroke/TIA related hospitalization is lower in the Continuous Monitoring arm compared to the Control arm.|||2.60|0.73|0.33
72558565|NCT01252953|144646770|OTHER|Time to first event|Rate Ratio|0.91||||0.004|TWO_SIDED|95.0|0.85|0.97|||Log Rank|||||0.97|0.85|0.004
72558566|NCT01252953|144646771|OTHER|Time to first event|Rate Ratio|0.93||||0.052|TWO_SIDED|95.0|0.86|1.0|||Log Rank|||||1|0.86|0.052
72558567|NCT01252953|144646772|OTHER|Time to first event|Rate Ratio|0.99|||||TWO_SIDED|95.0|0.87|1.12||In accordance with the data analysis plan, if the outcome of a major atherosclerotic event did not reach significance, there was no hypothesis testing for presumed ischemic stroke, so no P value is given.||||||1.12|0.87|
72495142|NCT02475655|144519359|SUPERIORITY||Mean Difference (Net)|11.0||||0.004|TWO_SIDED|90.0|4.84|17.1||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in Alanine Aminotransferase (ALT) (SGPT) values from Entry to Week 4/5.||17.1|4.84|0.004
72495143|NCT02475655|144519359|SUPERIORITY||Mean Difference (Net)|4.64||||0.043|TWO_SIDED|90.0|0.88|8.39||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in Alanine Aminotransferase (ALT) (SGPT) values from Entry to Week 10/12.||8.39|0.88|0.043
72495144|NCT02475655|144519360|SUPERIORITY||Mean Difference (Net)|1.1||||0.56|TWO_SIDED|90.0|0.84|1.44||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib geometric mean minus No Study Treatment geometric mean. All values were log10 transformed prior to calculating change and conducting analyses and back transformed for presentation.|Null hypothesis: There is no difference between the two arms in the fold change in Plasma Interleukin 6 (IL-6) from baseline to Week 10/12.||1.44|0.84|0.56
72495145|NCT02475655|144519360|SUPERIORITY||Mean Difference (Net)|1.37||||0.026|TWO_SIDED|90.0|1.09|1.73||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib geometric mean minus No Study Treatment geometric mean. All values were log10 transformed prior to calculating change and conducting analyses and back transformed for presentation.|Null hypothesis: There is no difference between the two arms in the fold change in Plasma Interleukin 6 (IL-6) from Week 4/5 to Week 10/12.||1.73|1.09|0.026
72495146|NCT02475655|144519361|SUPERIORITY||Mean Difference (Net)|0.89||||0.07|TWO_SIDED|90.0|0.8|0.99||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib geometric mean minus No Study Treatment geometric mean. All values were log10 transformed prior to calculating change and conducting analyses and back transformed for presentation.|Null hypothesis: There is no difference between the two arms in the fold change in soluble CD14 (sCD14) from baseline to Week 4/5.||0.99|0.80|0.07
72495147|NCT02475655|144519361|SUPERIORITY||Mean Difference (Net)|0.95||||0.59|TWO_SIDED|90.0|0.8|1.12||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib geometric mean minus No Study Treatment geometric mean. All values were log10 transformed prior to calculating change and conducting analyses and back transformed for presentation.|Null hypothesis: There is no difference between the two arms in the fold change in soluble CD14 (sCD14) from baseline to Week 12.||1.12|0.80|0.59
72558568|NCT01252953|144646773|OTHER|Time to first event|Rate Ratio|0.93||||0.02|TWO_SIDED|95.0|0.88|0.99|||Log Rank|||||0.99|0.88|0.02
72558569|NCT05604014|144646782|SUPERIORITY||Mean Difference (Final Values)|-0.7||||0.49|TWO_SIDED||||||t-test, 2 sided|||||||0.49
72558570|NCT05604014|144646783|SUPERIORITY||Mean Difference (Final Values)|-0.69||||0.5|TWO_SIDED||||||t-test, 2 sided|||||||0.5
72558571|NCT05604014|144646784|SUPERIORITY||Mean Difference (Final Values)|-1.44||||0.16|TWO_SIDED||||||t-test, 2 sided|||||||0.16
72558572|NCT05604014|144646785|SUPERIORITY||Mean Difference (Final Values)|-0.78||||0.44|TWO_SIDED||||||t-test, 2 sided|||||||0.44
72618820|NCT06097273|144768196|NON_INFERIORITY|The noninferiority in GM level in the Cohort A1 group compared with that of Cohort A2 group was demonstrated if the lower bound of the 97.5% CI of the GMR was \>0.667.|GMR|1.007|||||TWO_SIDED|97.5|0.969|1.047||||||GMR (Cohort A1 vs Cohort A2) for Influenza B Yamagata-lineage Antibody||1.047|0.969|
72495148|NCT02475655|144519361|SUPERIORITY||Mean Difference (Net)|1.06||||0.56|TWO_SIDED|90.0|0.9|1.24||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib geometric mean minus No Study Treatment geometric mean. All values were log10 transformed prior to calculating change and conducting analyses and back transformed for presentation.|Null hypothesis: There is no difference between the two arms in the fold change in soluble CD14 (sCD14) from Week 4/5 to Week 12.||1.24|0.90|0.56
72558573|NCT01026402|144646786|SUPERIORITY_OR_OTHER||Maximum Tolerated Dose|50.0|||||||||||||50mg twice daily continuous dosing 20 evaluable patients|||||
72558574|NCT01026402|144646786|SUPERIORITY_OR_OTHER||Maximum Tolerated Dose|100.0|||||||||||||100mg once daily continuous dosing 16 evaluable patients|||||
72558575|NCT01026402|144646786|SUPERIORITY_OR_OTHER||Maximum Tolerated Dose|125.0|||||||||||||125mg twice daily intermittent dosing (2 days on, 5 days off) 29 evaluable patients|||||
72558576|NCT00840203|144646807|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using the General Linear Model (GLM) procedure of SAS the bioequivalence of the test and reference products will be evaluated using average bioequivalence methodology for non-replicate crossover study design.|Geometric Test/Ref Ratio x 100|97.6||||||90.0|88.6|107.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||107|88.6|
72558577|NCT00840203|144646808|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using the General Linear Model (GLM) procedure of SAS the bioequivalence of the test and reference products will be evaluated using average bioequivalence methodology for non-replicate crossover study design.|Geometric Test/Ref Ratio x 100|97.3||||||90.0|82.8|114.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||114|82.8|
72558578|NCT00840203|144646809|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using the General Linear Model (GLM) procedure of SAS the bioequivalence of the test and reference products will be evaluated using average bioequivalence methodology for non-replicate crossover study design.|Geometric Test/Ref Ratio x 100|94.0||||||90.0|83.0|107.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||107|83.0|
72618821|NCT06097273|144768196|SUPERIORITY|The superiority in GM level in the Cohort A1 group compared with that of Cohort A2 group was demonstrated if the lower bound of the 95% CI of the GMR was \>1.|GMR|1.007|||||TWO_SIDED|95.0|0.973|1.042||||||GMR (Cohort A1 vs Cohort A2) for Influenza B Yamagata-lineage Antibody||1.042|0.973|
72385241|NCT02586064|144278470|OTHER|||||||0.64|||||||t-test, 1 sided|||Change||||0.64
72385242|NCT02586064|144278470|OTHER|||||||0.64|||||||t-test, 1 sided|||3 Month Post Treatment||||0.64
72385243|NCT02586064|144278470|OTHER|||||||0.76|||||||t-test, 1 sided|||6 Month Post Treatment||||0.76
72385244|NCT02586064|144278471|OTHER|||||||0.11|||||||t-test, 1 sided|||Baseline||||0.11
72558579|NCT00840203|144646810|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using the General Linear Model (GLM) procedure of SAS the bioequivalence of the test and reference products will be evaluated using average bioequivalence methodology for non-replicate crossover study design.|Geometric Test/Ref Ratio x 100|98.3||||||90.0|91.5|106.0|||||Metabolite results presented for informational purposes only.|||106|91.5|
72558580|NCT00840203|144646811|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using the General Linear Model (GLM) procedure of SAS the bioequivalence of the test and reference products will be evaluated using average bioequivalence methodology for non-replicate crossover study design.|Geometric Test/Ref Ratio x 100|97.6||||||90.0|86.7|110.0|||||Metabolite results presented for informational purposes only.|||110|86.7|
72558581|NCT00840203|144646812|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using the General Linear Model (GLM) procedure of SAS the bioequivalence of the test and reference products will be evaluated using average bioequivalence methodology for non-replicate crossover study design.|Geometric Test/Ref Ratio x 100|95.6||||||90.0|86.1|106.0|||||Metabolite results presented for informational purposes only.|||106|86.1|
72558582|NCT03349567|144646838|SUPERIORITY||Incident rate ratio|0.99||||0.35|TWO_SIDED|95.0|0.98|1.01|||Mixed Models Analysis|Segmented regression analysis was conducted using generalized linear models to estimate change in monthly antimicrobial prescription rates.||||1.01|0.98|0.35
72558583|NCT03349567|144646839|NON_INFERIORITY|A Poisson regression model with log link was used to estimate the rate of safety outcomes. Models were adjusted for time as a continuous covariate, an indicator for month of implementation of intervention (Oct 2018), and included random effects to account for repeated measurements. An interaction variable for the study period (baseline or intervention) and site (intervention or control) was included in the model to estimate the Incident Rate Ratio (IRR) and 95% CIs.|Incident rate ratio|1.12|||||TWO_SIDED|95.0|0.93|1.35||||||||1.35|0.93|
72618822|NCT06097273|144768196|NON_INFERIORITY|The noninferiority in GM level in the Cohort B1 group compared with that of Cohort B2 group was demonstrated if the lower bound of the 97.5% CI of the GMR was \>0.667.|GMR|1.216|||||TWO_SIDED|97.5|1.156|1.278||||||GMR (Cohort B1 vs Cohort B2) for Influenza B Victoria-lineage Antibody||1.278|1.156|
72385245|NCT02586064|144278471|OTHER|||||||0.48|||||||t-test, 1 sided|||4-Week||||0.48
72385246|NCT02586064|144278471|OTHER|||||||0.74|||||||t-test, 1 sided|||8-Week||||0.74
72385247|NCT02586064|144278471|OTHER|||||||0.34|||||||t-test, 1 sided|||End of Treatment||||0.34
72385248|NCT02586064|144278471|OTHER|||||||0.65|||||||t-test, 1 sided|||Change||||0.65
72385249|NCT02586064|144278471|OTHER|||||||0.14|||||||t-test, 1 sided|||3 Month Post Treatment||||0.14
72385250|NCT02586064|144278471|OTHER|||||||0.18|||||||t-test, 1 sided|||6 Month Post Treatment||||0.18
72385251|NCT02586064|144278472|OTHER|||||||0.08|||||||t-test, 1 sided|||Baseline||||0.08
72385252|NCT02586064|144278472|OTHER|||||||0.07|||||||t-test, 1 sided|||End of Treatment||||0.07
72385253|NCT02586064|144278472|OTHER|||||||0.86|||||||t-test, 1 sided|||Change||||0.86
72385254|NCT02586064|144278472|OTHER|||||||0.003|||||||t-test, 1 sided|||3 Month Post Treatment||||0.003
72385255|NCT02586064|144278472|OTHER|||||||0.03|||||||t-test, 1 sided|||6 Month Post Treatment||||0.03
72385256|NCT02586064|144278473|OTHER|||||||0.05|||||||t-test, 1 sided|||Baseline||||0.05
72385257|NCT02586064|144278473|OTHER|||||||0.04|||||||t-test, 1 sided|||End of Treatment||||0.04
72385258|NCT02586064|144278473|OTHER|||||||0.86|||||||t-test, 1 sided|||Change||||0.86
72385259|NCT02586064|144278473|OTHER||||||<|0.001|||||||t-test, 1 sided|||3 Month Post Treatment||||<0.001
72385260|NCT02586064|144278473|OTHER|||||||0.16|||||||t-test, 1 sided|||6 Month Post Treatment||||0.16
72385261|NCT02586064|144278474|OTHER|||||||0.45|||||||t-test, 1 sided|||Baseline||||0.45
72385262|NCT02586064|144278474|OTHER|||||||0.71|||||||t-test, 1 sided|||End of Treatment||||0.71
72385263|NCT02586064|144278474|OTHER|||||||0.6|||||||t-test, 1 sided|||Change||||0.60
72385264|NCT02586064|144278474|OTHER|||||||0.13|||||||t-test, 1 sided|||3 Month Post Treatment||||0.13
72385265|NCT02586064|144278474|OTHER|||||||0.8|||||||t-test, 1 sided|||6 Month Post Treatment||||0.80
72385266|NCT02586064|144278475|OTHER|||||||0.35|||||||t-test, 1 sided|||Baseline||||0.35
72385267|NCT02586064|144278475|OTHER|||||||0.11|||||||t-test, 1 sided|||End of Treatment||||0.11
72385268|NCT02586064|144278475|OTHER|||||||0.74|||||||t-test, 1 sided|||Change||||0.74
72385269|NCT02586064|144278475|OTHER|||||||0.03|||||||t-test, 1 sided|||3 Month Post Treatment||||0.03
72385270|NCT02586064|144278475|OTHER|||||||0.22|||||||t-test, 1 sided|||6 Month Post Treatment||||0.22
72385271|NCT02586064|144278476|OTHER|||||||0.39|||||||t-test, 1 sided|||Baseline||||0.39
72385272|NCT02586064|144278476|OTHER|||||||0.15|||||||t-test, 1 sided|||End of Treatment||||0.15
72385273|NCT02586064|144278476|OTHER|||||||0.72|||||||t-test, 1 sided|||Change||||0.72
72385274|NCT02586064|144278476|OTHER|||||||0.04|||||||t-test, 1 sided|||3 Month Post Treatment||||0.04
72385275|NCT02586064|144278476|OTHER|||||||0.19|||||||t-test, 1 sided|||6 Month Post Treatment||||0.19
72385276|NCT02586064|144278477|OTHER|||||||0.33|||||||t-test, 1 sided|||Baseline||||0.33
72385277|NCT02586064|144278477|OTHER|||||||0.11|||||||t-test, 1 sided|||End of Treatment||||0.11
72385278|NCT02586064|144278477|OTHER|||||||0.88|||||||t-test, 1 sided|||Change||||0.88
72385279|NCT02586064|144278477|OTHER|||||||0.06|||||||t-test, 1 sided|||3 Month Post Treatment||||0.06
72385280|NCT02586064|144278477|OTHER|||||||0.56|||||||t-test, 1 sided|||6 Month Post Treatment||||0.56
72385281|NCT02586064|144278478|OTHER|||||||0.16|||||||t-test, 1 sided|||Baseline||||0.16
72385282|NCT02586064|144278478|OTHER|||||||0.06|||||||t-test, 1 sided|||End of Treatment||||0.06
72385283|NCT02586064|144278478|OTHER|||||||0.46|||||||t-test, 1 sided|||Change||||0.46
72385284|NCT02586064|144278478|OTHER|||||||0.001|||||||t-test, 1 sided|||3 Month Post Treatment||||0.001
72385285|NCT02586064|144278478|OTHER|||||||0.002|||||||t-test, 1 sided|||6 Month Post Treatment||||0.002
72385286|NCT02586064|144278479|OTHER|||||||0.24|||||||t-test, 1 sided|||Baseline||||0.24
72385287|NCT02586064|144278479|OTHER|||||||0.81|||||||t-test, 1 sided|||End of Treatment||||0.81
72385288|NCT02586064|144278479|OTHER|||||||0.24|||||||t-test, 1 sided|||Change||||0.24
72385289|NCT02586064|144278480|OTHER|||||||0.41|||||||t-test, 1 sided|||Baseline||||0.41
72558584|NCT03349567|144646840|NON_INFERIORITY|A Poisson regression model with log link was used to estimate the rate of safety outcomes. Models were adjusted for time as a continuous covariate, an indicator for month of implementation of intervention (Oct 2018), and included random effects to account for repeated measurements. An interaction variable for the study period (baseline or intervention) and site (intervention or control) was included in the model to estimate the Incident Rate Ratio (IRR) and 95% CIs.|Incident rate ratio|1.01|||||TWO_SIDED|95.0|0.81|1.27||||||||1.27|0.81|
72618823|NCT06097273|144768196|SUPERIORITY|The superiority in GM level in the Cohort B1 group compared with that of Cohort B2 group was demonstrated if the lower bound of the 95% CI of the GMR was \>1.|GMR|1.216|||||TWO_SIDED|95.0|1.163|1.27||||||GMR (Cohort B1 vs Cohort B2) for Influenza B Victoria-lineage Antibody||1.270|1.163|
72385290|NCT02586064|144278480|OTHER|||||||0.21|||||||t-test, 1 sided|||End of Treatment||||0.21
72385291|NCT02586064|144278480|OTHER|||||||0.5|||||||t-test, 1 sided|||Change||||0.50
72385292|NCT02586064|144278481|OTHER|||||||0.7|||||||t-test, 1 sided|||Baseline||||0.70
72385293|NCT02586064|144278481|OTHER|||||||0.96|||||||t-test, 1 sided|||Week 4||||0.96
72385294|NCT02586064|144278481|OTHER|||||||0.59|||||||t-test, 1 sided|||Week 8||||0.59
72385295|NCT02586064|144278481|OTHER|||||||0.61|||||||t-test, 1 sided|||End of Treatment||||0.61
72385296|NCT02586064|144278481|OTHER|||||||0.84|||||||t-test, 1 sided|||Change||||0.84
72385297|NCT02586064|144278481|OTHER|||||||0.3|||||||t-test, 1 sided|||3 Month Follow Up||||0.30
72437645|NCT00430300|144388374|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.8||0.899|ONE_SIDED|95.0|-2.2||||Mixed Models Analysis|||TDI at Week 6: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-2.2|0.8990
72437646|NCT00430300|144388375|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.15||0.8757|ONE_SIDED|95.0|-0.42||||Mixed Models Analysis|||Cough, Change at Week 1: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.42|0.8757
72437647|NCT00430300|144388375|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.15||0.6334|ONE_SIDED|95.0|-0.3||||Mixed Models Analysis|||Cough, Change at Week 1: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.30|0.6334
72437648|NCT00430300|144388375|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.13||0.5448|ONE_SIDED|95.0|-0.23||||Mixed Models Analysis|||Cough, Change at Week 1: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.23|0.5448
72437649|NCT00430300|144388375|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.16||0.6986|ONE_SIDED|95.0|-0.34||||Mixed Models Analysis|||Cough, Change at Week 2: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.34|0.6986
72618824|NCT06097273|144768196|NON_INFERIORITY|The noninferiority in GM level in the Cohort B1 group compared with that of Cohort B2 group was demonstrated if the lower bound of the 97.5% CI of the GMR was \>0.667.|GMR|1.154|||||TWO_SIDED|97.5|1.109|1.201||||||GMR (Cohort B1 vs Cohort B2) for Influenza B Yamagata-lineage Antibody||1.201|1.109|
72385298|NCT02586064|144278481|OTHER|||||||0.16|||||||t-test, 1 sided|||6 Month Post Treatment||||0.16
72385299|NCT00165984|144278490|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.9||||0.003|TWO_SIDED|95.0|1.7|13.9|||Regression, Cox|||||13.9|1.7|0.003
72385300|NCT02130024|144278524|OTHER||Treatment Effect|0.08||||0.236|TWO_SIDED|95.0|-0.05|0.21|||Mixed Models Analysis|Fixed effects: Baseline GA area, treatment, visit, treatment by visit. Random effect: Subject||||0.21|-0.05|0.236
72385301|NCT02130024|144278525|OTHER||Treatment Effect|0.02||||0.769|TWO_SIDED|95.0|-0.11|0.15|||Mixed Models Analysis|Fixed effects: Baseline GA area, treatment, visit, treatment by visit. Random effect: Subject||||0.15|-0.11|0.769
72385302|NCT02130024|144278526|OTHER||Odds Ratio (OR)|0.84||||0.586|TWO_SIDED|95.0|0.44|1.59|||Regression, Logistic|Includes treatment as factor. Model: log(p/1-p) =Treatment|Odds ratio of 'Newly Developed GA (Yes)' at between the two treatment groups at study visit|Baseline to Month 12 Analysis||1.59|0.44|0.586
72385303|NCT02130024|144278526|OTHER||Odds Ratio (OR)|2.27||||0.11|TWO_SIDED|95.0|0.83|6.22|||Regression, Logistic|Includes treatment as factor. Model: log(p/1-p) =Treatment|Odds ratio of 'Newly Developed GA (Yes)' at between the two treatment groups at study visit|Month 12 to Month 24 Analysis||6.22|0.83|0.110
72385304|NCT02130024|144278526|OTHER||Odds Ratio (OR)|1.19||||0.554|TWO_SIDED|95.0|0.67|2.09|||Regression, Logistic|Includes treatment as factor. Model: log(p/1-p) =Treatment||Baseline to Month 24 Analysis||2.09|0.67|0.554
72385305|NCT02130024|144278527|OTHER||Treatment Effect|0.99||||0.733|TWO_SIDED|95.0|0.95|1.04|||Negative Binomial Regression Model|Log (number of injections) = treatment + log (year of follow-up) (offset)|Treatment effect: Injection frequency (rate) ratio of Ranibizumab vs. Aflibercept|Baseline to \<Month 12 Analysis||1.04|0.95|0.733
72385306|NCT02130024|144278527|OTHER||Treatment Effect|1.01||||0.745|TWO_SIDED|95.0|0.95|1.08|||Negative Binomial Regression Model|Log (number of injections) = treatment + log (year of follow-up) (offset)|Treatment effect: Injection frequency (rate) ratio of Ranibizumab vs. Aflibercept|Baseline to Month 24 Analysis||1.08|0.95|0.745
72385307|NCT02130024|144278528|OTHER||Treatment Effect|2.32||||0.079|TWO_SIDED|95.0|-0.27|4.92|||Mixed Models Analysis|Fixed effects: Baseline BCVA, treatment, visit, and treatment by visit. Random effect: Subject. Response variable: Change from baseline in BCVA|Treatment Effect: Ranibizumab minus Aflibercept|Baseline to Month 12 Analysis||4.92|-0.27|0.079
72385308|NCT02130024|144278528|OTHER||Treatment Effect|1.95||||0.151|TWO_SIDED|95.0|-0.71|4.61|||Mixed Models Analysis|Fixed effects: Baseline BCVA, treatment, visit, and treatment by visit. Random effect: Subject. Response variable: Change from baseline in BCVA|Treatment Effect: Ranibizumab minus Aflibercept|Baseline to Month 24 Analysis||4.61|-0.71|0.151
72385309|NCT02130024|144278529|OTHER||Treatment Effect|10.12||||0.294|TWO_SIDED|95.0|-8.82|29.06|||Mixed Models Analysis|Fixed effects: Baseline CSFT, treatment, visit, and treatment by visit. Random effect: Subject. Response variable: Change from baseline in CSFT|Treatment Effect: Ranibizumab minus Aflibercept|Baseline to Month 12 Analysis||29.06|-8.82|0.294
72618825|NCT06097273|144768196|SUPERIORITY|The superiority in GM level in the Cohort B1 group compared with that of Cohort B2 group was demonstrated if the lower bound of the 95% CI of the GMR was \>1.|GMR|1.154|||||TWO_SIDED|95.0|1.115|1.195||||||GMR (Cohort B1 vs Cohort B2) for Influenza B Yamagata-lineage Antibody||1.195|1.115|
72385310|NCT02130024|144278529|OTHER||Treatment Effect|11.86||||0.225|TWO_SIDED|95.0|-7.35|31.07|||Mixed Models Analysis|Fixed effects: Baseline CSFT, treatment, visit, and treatment by visit. Random effect: Subject. Response variable: Change from baseline in CSFT|Treatment Effect: Ranibizumab minus Aflibercept|Baseline to Month 24 Analysis||31.07|-7.35|0.225
72385311|NCT02130024|144278530|OTHER||Odds Ratio (OR)|0.83||||0.461|TWO_SIDED|95.0|0.51|1.35|||Regression, Logistic|Includes treatment as factor. Model: log(p/1-p) =Treatment|Odds ratio of no IRF/SRF present between the two treatment groups at study visit|Month 2 Analysis||1.35|0.51|0.461
72385312|NCT02130024|144278530|OTHER||Odds Ratio (OR)|0.72||||0.215|TWO_SIDED|95.0|0.44|1.21|||Regression, Logistic|Includes treatment as factor. Model: log(p/1-p) =Treatment|Odds ratio of no IRF/SRF present between the two treatment groups at study visit|Month 12 Analysis||1.21|0.44|0.215
72385313|NCT02130024|144278530|OTHER||Odds Ratio (OR)|0.87||||0.616|TWO_SIDED|95.0|0.51|1.48|||Regression, Logistic|Includes treatment as factor. Model: log(p/1-p) =Treatment|Odds ratio of no IRF/SRF present between the two treatment groups at study visit|Month 24 Analysis||1.48|0.51|0.616
72385314|NCT02130024|144278531|OTHER||Odds Ratio (OR)|1.05||||0.891|TWO_SIDED|95.0|0.53|2.08|||Regression, Logistic|Includes treatment as factor and baseline BCVA as covariate. Model: log(p/1-p) =Treatment|Odds ratio of BCVA change from baseline ≥15 letters between the two treatment groups at study visit|Baseline to Month 12 Analysis||2.08|0.53|0.891
72385315|NCT02130024|144278531|OTHER||Odds Ratio (OR)|1.61||||0.206|TWO_SIDED|95.0|0.77|3.35|||Regression, Logistic|Includes treatment as factor and baseline BCVA as covariate. Model: log(p/1-p) =Treatment|Odds ratio of BCVA change from baseline ≥15 letters between the two treatment groups at study visit|Baseline to Month 24 Analysis||3.35|0.77|0.206
72385316|NCT02130024|144278532|OTHER||Odds Ratio (OR)|1.63||||0.46|TWO_SIDED|95.0|0.45|5.93|||Regression, Logistic|Includes treatment as factor and baseline BCVA as covariate. Model: log(p/1-p) =Treatment|Odds ratio of BCVA change from baseline ≥ -15 letters between the two treatment groups at study visit|Baseline to Month 12 Analysis||5.93|0.45|0.460
72385317|NCT02130024|144278532|OTHER||Odds Ratio (OR)|0.94||||0.913|TWO_SIDED|95.0|0.3|2.9|||Regression, Logistic|Includes treatment as factor and baseline BCVA as covariate. Model: log(p/1-p) =Treatment|Odds ratio of BCVA change from baseline ≥ -15 letters between the two treatment groups at study visit|Baseline to Month 24 Analysis||2.90|0.30|0.913
72385318|NCT02130024|144278534|OTHER||Treatment Effect|27.2|||<|0.001|TWO_SIDED|95.0|21.44|32.95|||Mixed Models Analysis|Fixed: BL Plasma VEGF, treatment, visit, and treatment by visit. Random effect: Subject. Response variable: Change from BL in Plasma VEGF|Treatment Effect: Ranibizumab minus Aflibercept|Baseline to Week 5 Analysis||32.95|21.44|<0.001
72385319|NCT02130024|144278534|OTHER||Treatment Effect|28.88|||<|0.001|TWO_SIDED|95.0|23.08|34.68|||Mixed Models Analysis|Fixed: BL Plasma VEGF, treatment, visit, and treatment by visit. Random effect: Subject. Response variable: Change from BL in Plasma VEGF|Treatment Effect: Ranibizumab minus Aflibercept|Baseline to Week 9 Analysis||34.68|23.08|<0.001
72385320|NCT03507400|144278560|SUPERIORITY|||||||0.63|||||||Wilcoxon (Mann-Whitney)|||||||0.63
72385321|NCT03507400|144278560|SUPERIORITY|||||||0.003|||||||Wilcoxon (Mann-Whitney)|Wilcoxon paired test||pooled comparison of the participants of the non-waiting list and the waiting list before and after Introvision||||0.003
72385322|NCT03507400|144278562|SUPERIORITY|||||||0.004|||||||Wilcoxon (Mann-Whitney)|||||||0.004
72385323|NCT03507400|144278563|SUPERIORITY|||||||0.003|||||||Wilcoxon (Mann-Whitney)|Wilcoxon paired test||||||0.003
72385324|NCT03507400|144278564|SUPERIORITY|||||||0.001|||||||Wilcoxon (Mann-Whitney)|Wilcoxon paired test||||||0.001
72385325|NCT03507400|144278565|SUPERIORITY|||||||0.001|||||||Wilcoxon (Mann-Whitney)|Wilcoxon paired test||||||0.001
72385326|NCT03507400|144278569|SUPERIORITY|Wilcoxon paired test||||||0.04|||||||Wilcoxon (Mann-Whitney)|||||||0.04
72385327|NCT03507400|144278569|SUPERIORITY|||||||0.25|||||||Wilcoxon (Mann-Whitney)|||||||0.25
72385328|NCT03507400|144278569|SUPERIORITY|||||||0.02|||||||Wilcoxon (Mann-Whitney)|||||||0.02
72385329|NCT04806503|144278596|OTHER|Mixed-effect Model for Repeated Measures model-based two-sided t-test|Least Squares Mean|0.006|STANDARD_ERROR_OF_MEAN|0.0258||0.817|TWO_SIDED|95.0|-0.045|0.056|||Mixed-effect Model for Repeated Measures|||||0.056|-0.045|0.817
72385330|NCT04806503|144278596|OTHER|Mixed-effect Model for Repeated Measures model-based two-sided t-test|Least Squares Mean|0.002|STANDARD_ERROR_OF_MEAN|0.0262||0.946|TWO_SIDED|95.0|-0.05|0.053|||Mixed-effect Model for Repeated Measures|||||0.053|-0.050|0.946
72385331|NCT04806503|144278596|OTHER|Mixed-effect Model for Repeated Measures model-based two-sided t-test|Least Squares Mean|-0.024|STANDARD_ERROR_OF_MEAN|0.027||0.38|TWO_SIDED|95.0|-0.077|0.029|||Mixed-effect Model for Repeated Measures|||||0.029|-0.077|0.380
72385332|NCT04806503|144278596|OTHER|Mixed-effect Model for Repeated Measures model-based two-sided t-test|Least Squares Mean|0.011|STANDARD_ERROR_OF_MEAN|0.0258||0.667|TWO_SIDED|95.0|-0.039|0.062|||Mixed-effect Model for Repeated Measures|||||0.062|-0.039|0.667
72385333|NCT04806503|144278597|OTHER|Mixed-effect Model for Repeated Measures model-based two-sided t-test|Least Squares Mean|0.022|STANDARD_ERROR_OF_MEAN|0.0304||0.474|TWO_SIDED|95.0|-0.038|0.081|||Mixed-effect Model for Repeated Measures|||||0.081|-0.038|0.474
72385334|NCT04806503|144278597|OTHER|Mixed-effect Model for Repeated Measures model-based two-sided t-test|Least Squares Mean|0.025|STANDARD_ERROR_OF_MEAN|0.0309||0.419|TWO_SIDED|95.0|-0.036|0.086|||Mixed-effect Model for Repeated Measures|||||0.086|-0.036|0.419
72385335|NCT04806503|144278597|OTHER|Mixed-effect Model for Repeated Measures model-based two-sided t-test|Least Squares Mean|0.003|STANDARD_ERROR_OF_MEAN|0.0322||0.914||95.0|-0.06|0.067|||Mixed-effect Model for Repeated Measures|||||0.067|-0.060|0.914
72385336|NCT04806503|144278597|OTHER|Mixed-effect Model for Repeated Measures model-based two-sided t-test|Least Squares Mean|0.034|STANDARD_ERROR_OF_MEAN|0.0305||0.263|TWO_SIDED|95.0|-0.026|0.094|||Mixed-effect Model for Repeated Measures|||||0.094|-0.026|0.263
72385337|NCT04806503|144278598|OTHER|Mixed-effect Model for Repeated Measures model-based two-sided t-test|Least Squares Mean|0.029|STANDARD_ERROR_OF_MEAN|0.0273||0.284|TWO_SIDED|95.0|-0.024|0.083|||Mixed-effect Model for Repeated Measures|||||0.083|-0.024|0.284
72385338|NCT04806503|144278598|OTHER|Mixed-effect Model for Repeated Measures model-based two-sided t-test|Least Squares Mean|0.01|STANDARD_ERROR_OF_MEAN|0.0278||0.711|TWO_SIDED|95.0|-0.044|0.065|||Mixed-effect Model for Repeated Measures|||||0.065|-0.044|0.711
72558585|NCT03349567|144646841|NON_INFERIORITY|A Poisson regression model with log link was used to estimate the rate of safety outcomes. Models were adjusted for time as a continuous covariate, an indicator for month of implementation of intervention (Oct 2018), and included random effects to account for repeated measurements. An interaction variable for the study period (baseline or intervention) and site (intervention or control) was included in the model to estimate the Incident Rate Ratio (IRR) and 95% CIs.|Incident rate ratio|0.88|||||TWO_SIDED|95.0|0.58|1.34||||||||1.34|0.58|
72558586|NCT03349567|144646842|NON_INFERIORITY|A Poisson regression model with log link was used to estimate the rate of safety outcomes. Models were adjusted for time as a continuous covariate, an indicator for month of implementation of intervention (Oct 2018), and included random effects to account for repeated measurements. An interaction variable for the study period (baseline or intervention) and site (intervention or control) was included in the model to estimate the Incident Rate Ratio (IRR) and 95% CIs.|Incident rate ratio|0.83|||||TWO_SIDED|95.0|0.53|1.29||||||||1.29|0.53|
72558587|NCT03349567|144646843|SUPERIORITY|||||||0.001|||||||Chi-squared|||||||0.001
72558588|NCT03349567|144646843|SUPERIORITY|||||||0.13|||||||Chi-squared|||||||0.13
72558589|NCT03349567|144646844|SUPERIORITY|||||||0.46|||||||Regression, Logistic|Segmented regression analysis was conducted using generalized linear models to estimate change in monthly antibiotic prescription rates.||||||0.46
72385339|NCT04806503|144278598|OTHER|Mixed-effect Model for Repeated Measures model-based two-sided t-test|Least Squares Mean|0.005|STANDARD_ERROR_OF_MEAN|0.0284||0.871|TWO_SIDED|95.0|-0.051|0.06|||Mixed-effect Model for Repeated Measures|||||0.060|-0.051|0.871
72385340|NCT04806503|144278598|OTHER|Mixed-effect Model for Repeated Measures model-based two-sided t-test|Least Squares Mean|0.027|STANDARD_ERROR_OF_MEAN|0.0273||0.329|TWO_SIDED|95.0|-0.027|0.08|||Mixed-effect Model for Repeated Measures|||||0.080|-0.027|0.329
72385341|NCT04806503|144278599|OTHER|Logistic model-based one-sided t-test|Odds Ratio (OR)|0.95||||0.516|TWO_SIDED|95.0|0.083|10.847|||Multiple Imputation, Logistic Regression|||||10.847|0.083|0.516
72385342|NCT04806503|144278599|OTHER|Logistic model-based one-sided t-test|Odds Ratio (OR)|2.45||||0.177|TWO_SIDED|95.0|0.367|16.398|||Multiple Imputation, Logistic Regression|||||16.398|0.367|0.177
72385343|NCT04806503|144278599|OTHER|Logistic model-based one-sided t-test|Odds Ratio (OR)|3.65||||0.079|TWO_SIDED|95.0|0.604|22.094|||Multiple Imputation, Logistic Regression|||||22.094|0.604|0.079
72385344|NCT04806503|144278599|OTHER|Logistic model-based one-sided t-test|Odds Ratio (OR)|1.07||||0.476|TWO_SIDED|95.0|0.136|8.381|||Multiple Imputation, Logistic Regression|||||8.381|0.136|0.476
72385345|NCT04806503|144278600|OTHER|Logistic model-based one-sided t-test|Odds Ratio (OR)|0.87||||0.577|TWO_SIDED|95.0|0.201|3.726|||Multiple Imputation, Logistic Regression|||||3.726|0.201|0.577
72437650|NCT00430300|144388375|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.08|STANDARD_ERROR_OF_MEAN|0.16||0.3151|ONE_SIDED|95.0|-0.18||||Mixed Models Analysis|||Cough, Change at Week 2: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.18|0.3151
72437651|NCT00430300|144388375|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.12|STANDARD_ERROR_OF_MEAN|0.14||0.1802|ONE_SIDED|95.0|-0.1||||Mixed Models Analysis|||Cough, Change at Week 2: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.10|0.1802
72558590|NCT02227238|144646883|SUPERIORITY|Non-inferiority of DTG plus 2 NRTI's was to be declared if the lower bound of 95% confidence interval (CI) for the difference in snapshot response rates (DTG - LPV/RTV) is greater than - 12%. This was also performed using the Per-Protocol (PP) Population. If both analyses show non-inferiority, the hypothesis of antiviral effect of DTG + 2 NRTI's was superior to LPV/RTV + 2 NRTIs was to be tested.|Proportion difference|13.8|||<|0.001|TWO_SIDED|95.0|7.3|20.3|||Cochran-Mantel-Haenszel||Adjusted proportion difference, calculated as proportion on DTG minus that on LPV/RTV and based on Cochran-Mantel Haenszel stratified analysis adjusting for Baseline plasma HIV-1 RNA and number of fully active background NRTIs, has been presented.||Superiority would be declared if the lower end of the confidence interval was above 0%|20.3|7.3|<.001
72437652|NCT00430300|144388375|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.16||0.9102|ONE_SIDED|95.0|-0.49||||Mixed Models Analysis|||Cough, Change at Week 3: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.49|0.9102
72558591|NCT02227238|144646886|OTHER||Proportion difference|5.7|||||TWO_SIDED|95.0|2.2|9.3|||||Proportion difference, calculated as proportion on DTG minus proportion on LPV/RTV, at Week 24 has been presented.|||9.3|2.2|
72385346|NCT04806503|144278600|OTHER|Logistic model-based one-sided t-test|Odds Ratio (OR)|0.52||||0.804|TWO_SIDED|95.0|0.113|2.353|||Multiple Imputation, Logistic Regression|||||2.353|0.113|0.804
72385347|NCT04806503|144278600|OTHER|Logistic model-based one-sided t-test|Odds Ratio (OR)|0.34||||0.85|TWO_SIDED|95.0|0.045|2.602|||Multiple Imputation, Logistic Regression|||||2.602|0.045|0.850
72385348|NCT04806503|144278600|OTHER|Logistic model-based one-sided t-test|Odds Ratio (OR)|0.69||||0.684|TWO_SIDED|95.0|0.157|3.08|||Multiple Imputation, Logistic Regression|||||3.080|0.157|0.684
72385349|NCT04806503|144278601|OTHER|Logistic model-based one-sided t-test|Odds Ratio (OR)|0.56||||0.728|TWO_SIDED|95.0|0.089|3.593|||Multiple Imputation, Logistic Regression|||||3.593|0.089|0.728
72385350|NCT04806503|144278601|OTHER|Logistic model-based one-sided t-test|Odds Ratio (OR)|1.16||||0.428|TWO_SIDED|95.0|0.242|5.529|||Multiple Imputation, Logistic Regression|||||5.529|0.242|0.428
72385351|NCT04806503|144278601|OTHER|Logistic model-based one-sided t-test|Odds Ratio (OR)|0.0||||0.5|TWO_SIDED|95.0|0.0||NA when n = 1.||Multiple Imputation, Logistic Regression||||||0.000|0.500
72385352|NCT04806503|144278601|OTHER|Logistic model-based one-sided t-test|Odds Ratio (OR)|0.28||||0.851|TWO_SIDED|95.0|0.026|3.07|||Multiple Imputation, Logistic Regression|||||3.070|0.026|0.851
72385353|NCT04195906|144278629|SUPERIORITY||Least Squares Mean Difference|0.27|STANDARD_ERROR_OF_MEAN|1.328||0.877|TWO_SIDED|96.0|-2.46|3.0||The MMRM model includes fixed effect terms for randomized treatment, visit, baseline sodium thiosulfate use, baseline BWAT-CUA score and visit by randomized treatment interaction.|MMRM|MMRM=Mixed model for repeated measures Participant is fitted as random effect and an unstructured variance-covariance matrix is used.||||3.00|-2.46|0.877
72558592|NCT02227238|144646886|OTHER||Proportion difference|9.8|||||TWO_SIDED|95.0|5.3|14.4|||||Proportion difference, calculated as proportion on DTG minus proportion on LPV/RTV, at Week 48 has been presented.|||14.4|5.3|
72495149|NCT02475655|144519362|SUPERIORITY||Mean Difference (Net)|142.1||||0.007|TWO_SIDED|90.0|57.6|227.0||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in CD4+ T cell counts from Baseline to Week 2.||227|57.6|0.007
72495150|NCT02475655|144519362|SUPERIORITY||Mean Difference (Net)|74.3||||0.14|TWO_SIDED|90.0|-8.23|156.7||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in CD4+ T cell counts from Baseline to Week 5.||156.7|-8.23|0.14
72495151|NCT02475655|144519362|SUPERIORITY||Mean Difference (Net)|-38.9||||0.54|TWO_SIDED|90.0|-143.0|65.5||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in CD4+ T cell counts from Baseline to Week 12.||65.5|-143|0.54
72495152|NCT02475655|144519362|SUPERIORITY||Mean Difference (Net)|-112.0||||0.12|TWO_SIDED|90.0|-231.0|5.9||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|There is no difference between the two arms in the change in CD4+ T cell counts from Week 5 to Week 12.||5.90|-231|0.12
72495153|NCT02475655|144519364|SUPERIORITY||Risk Ratio (RR)|0.98||||0.94|TWO_SIDED|90.0|0.65|1.49||Not adjusted for multiple comparisons. Two-sided 10% alpha.|GEE|A GEE model for binary data was used to compare changes in iSCA because a substantial proportion of data was below the assay limit.|Risk ratio is Ruxolitinib risk divided by No Study Treatment risk.|Null hypothesis: There is no difference between the two arms in the change in HIV-1 RNA by iSCA from Entry to Week 5.||1.49|0.65|0.94
72495154|NCT02475655|144519364|SUPERIORITY||Risk Ratio (RR)|0.74||||0.46|TWO_SIDED|90.0|0.37|1.46||Not adjusted for multiple comparisons. Two-sided 10% alpha.|GEE|A GEE model for binary data was used to compare changes in iSCA because a substantial proportion of data was below the assay limit.|Risk ratio is Ruxolitinib risk divided by No Study Treatment risk.|Null hypothesis: There is no difference between the two arms in the change in HIV-1 RNA by iSCA from Entry to Week 12.||1.46|0.37|0.46
72495155|NCT02475655|144519364|SUPERIORITY||Risk Ratio (RR)|0.83||||0.59|TWO_SIDED|90.0|0.46|1.48||Not adjusted for multiple comparisons. Two-sided 10% alpha.|GEE|A GEE model for binary data was used to compare changes in iSCA because a substantial proportion of data was below the assay limit.|Risk ratio is Ruxolitinib risk divided by No Study Treatment risk.|Null hypothesis: There is no difference between the two arms in the change in HIV-1 RNA by iSCA from Week 5 to Week 12.||1.48|0.46|0.59
72495156|NCT02475655|144519365|SUPERIORITY||Mean Difference (Net)|0.88||||0.11|TWO_SIDED|90.0|0.76|1.01||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib geometric mean minus No Study Treatment geometric mean. All values were log10 transformed prior to calculating change and conducting analyses and back transformed for presentation.|Null hypothesis: There is no difference between the two arms in the fold change in Tumor Necrosis Factor alpha (TNF alpha) from entry to Week 5.||1.01|0.76|0.11
72495157|NCT02475655|144519365|SUPERIORITY||Mean Difference (Net)|0.92||||0.71|TWO_SIDED|90.0|0.64|1.33||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib geometric mean minus No Study Treatment geometric mean. All values were log10 transformed prior to calculating change and conducting analyses and back transformed for presentation.|Null hypothesis: There is no difference between the two arms in the fold change in Tumor Necrosis Factor alpha (TNF alpha) from entry to Week 12.||1.33|0.64|0.71
72495158|NCT02475655|144519366|SUPERIORITY||Mean Difference (Net)|1.27||||0.3|TWO_SIDED|90.0|0.87|1.86||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib geometric mean minus No Study Treatment geometric mean. All values were log10 transformed prior to calculating change and conducting analyses and back transformed for presentation.|Null hypothesis: There is no difference between the two arms in the fold change in Interleukin 1 beta (IL-1 beta) from entry to Week 5.||1.86|0.87|0.30
72495159|NCT02475655|144519366|SUPERIORITY||Mean Difference (Net)|1.59||||0.46|TWO_SIDED|90.0|0.56|4.49||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib geometric mean minus No Study Treatment geometric mean. All values were log10 transformed prior to calculating change and conducting analyses and back transformed for presentation.|Null hypothesis: There is no difference between the two arms in the fold change in Interleukin 1 beta (IL-1 beta) from entry to Week 12.||4.49|0.56|0.46
72495160|NCT02475655|144519367|SUPERIORITY||Mean Difference (Net)|1.29||||0.24|TWO_SIDED|90.0|0.9|1.84||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib geometric mean minus No Study Treatment geometric mean. All values were log10 transformed prior to calculating change and conducting analyses and back transformed for presentation.|Null hypothesis: There is no difference between the two arms in the fold change in Interleukin 7 (IL-7) from entry to Week 5.||1.84|0.90|0.24
72495161|NCT02475655|144519367|SUPERIORITY||Mean Difference (Net)|1.19||||0.46|TWO_SIDED|90.0|0.81|1.74||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib geometric mean minus No Study Treatment geometric mean. All values were log10 transformed prior to calculating change and conducting analyses and back transformed for presentation.|Null hypothesis: There is no difference between the two arms in the fold change in Interleukin 7 (IL-7) from entry to Week 12.||1.74|0.81|0.46
72495162|NCT02475655|144519372|SUPERIORITY||Mean Difference (Net)|1.15||||0.56|TWO_SIDED|90.0|0.77|1.72||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.||Null hypothesis: There is no difference between the two arms in the fold change in Interleukin 10 (IL-10) from entry to Week 5.|Mean difference is Ruxolitinib geometric mean minus No Study Treatment geometric mean. All values were log10 transformed prior to calculating change and conducting analyses and back transformed for presentation.|1.72|0.77|0.56
72558593|NCT02227238|144646913|OTHER||Mean Difference (Net)|-0.171||||0.001|TWO_SIDED|95.0|-0.272|-0.069|||Multiple imputation||Mean difference at Week 24 was calculated using multiple imputation using missing at random, adjusting for Baseline LDL cholesterol, Baseline plasma HIV-1 RNA, Baseline number of Fully Active NRTIs in the background regimen and Age|||-0.069|-0.272|0.0010
72558594|NCT02227238|144646913|OTHER||Mean Difference (Net)|-0.147||||0.01|TWO_SIDED|95.0|-0.259|-0.035|||'Multiple imputation||Mean difference at Week 48 was calculated using multiple imputation using missing at random, adjusting for Baseline LDL cholesterol, Baseline plasma HIV-1 RNA, Baseline number of Fully Active NRTIs in the background regimen and Age|||-0.035|-0.259|0.0100
72558595|NCT02227238|144646914|OTHER||Mean Difference (Net)|-0.542|||<|0.0001|TWO_SIDED|95.0|-0.729|-0.356|||Multiple imputation||Estimates at Week 24 are calculated using multiple imputation using missing at random, adjusting for Baseline total cholesterol/HDL ratio, Baseline plasma HIV-1 RNA, Baseline number of Fully Active NRTIs in the background regimen and Age.|||-0.356|-0.729|<0.0001
72558596|NCT02227238|144646914|OTHER||Mean Difference (Net)|-0.358||||0.0004|TWO_SIDED|95.0|-0.555|-0.161|||Multiple imputation||Estimates at Week 48 are calculated using multiple imputation using missing at random, adjusting for Baseline total cholesterol/HDL ratio, Baseline plasma HIV-1 RNA, Baseline number of Fully Active NRTIs in the background regimen and Age.|||-0.161|-0.555|0.0004
72558597|NCT03966911|144646928|SUPERIORITY||Intercept from ANCOVA as agreement rate|88.0|||<|0.041|TWO_SIDED|91.8|86.05|89.95|||ANCOVA|A generalized estimating equation model was used, considering correlation structure of day of sensor wear (1-7).|A group sequential study design was utilized to perform interim analysis. For the final stage, the p-value is 0.041.|||89.95|86.05|<0.041
72558598|NCT03966911|144646928|SUPERIORITY||Intercept from ANCOVA as agreement rate|87.96|||<|0.041|TWO_SIDED|91.8|86.13|89.8|||ANCOVA|A generalized estimating equation model was used, considering correlation structure of day of sensor wear (1-7).|A group sequential study design was utilized to perform interim analysis. For the final stage, the p-value is 0.041.|||89.80|86.13|<0.041
72385354|NCT04195906|144278630|SUPERIORITY||Least Squares Mean Difference|11.49|STANDARD_ERROR_OF_MEAN|7.93||0.146|TWO_SIDED|96.0|-4.8|27.78||The MMRM model includes fixed effect terms for randomized treatment, visit, baseline sodium thiosulfate use, baseline Pain VAS and visit by randomized treatment interaction.|MMRM|MMRM: mixed model repeated measures. Participant is fitted as random effect and an unstructured variance-covariance matrix is used.||||27.78|-4.80|0.146
72385355|NCT04195906|144278631|SUPERIORITY||Least Squares Mean Difference|0.09|STANDARD_ERROR_OF_MEAN|0.237||0.706|TWO_SIDED|96.0|-0.38|0.56||The MMRM model includes fixed effect terms for randomized treatment, visit, baseline sodium thiosulfate use, baseline Pain VAS and visit by randomized treatment interaction.|MMRM|MMRM: mixed model repeated measures. Participant is fitted as random effect and an unstructured variance-covariance matrix is used.||||0.56|-0.38|0.706
72385356|NCT04195906|144278632|SUPERIORITY||Least Squares Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|2.63||0.995|TWO_SIDED|96.0|-5.27|5.24||The MMRM model includes fixed effect terms for randomized treatment, visit, baseline sodium thiosulfate use, baseline Pain VAS and visit by randomized treatment interaction.|MMRM|MMRM: mixed model repeated measures. Participant is fitted as random effect and an unstructured variance-covariance matrix is used.||||5.24|-5.27|0.995
72385357|NCT04195906|144278633|SUPERIORITY||Odds Ratio, log|1.54|STANDARD_ERROR_OF_MEAN|0.498||0.384|TWO_SIDED|95.0|0.58|4.09||This model includes the stratification factor sodium thiosulfate use at baseline and the treatment as covariates|Regression, Logistic|As there is only a measure post-baseline, a logistic regression model was run instead of a generalized estimating equations model.|The odds ratio displayed is the odds ratio of having an improved result of SNF472 versus Placebo. The results 'Worsened', 'Equal', and 'Missing' are combined in one category and it is the reference for the odds ratio calculation.|||4.09|0.58|0.384
72385358|NCT04195906|144278634|SUPERIORITY||Difference in slopes between arms|0.57|STANDARD_ERROR_OF_MEAN|0.68||0.406|TWO_SIDED|95.0|-0.79|1.93||MMRM model includes fixed effect terms for randomized treatment, continuous variables maintenance opioid dose, Week (1 to 12) and Week by randomized treatment interaction. The random coefficients are the intercept and Week as a continuous variable.|MMRM|MMRM: mixed model repeated measures. An unstructured variance-covariance matrix is used||||1.93|-0.79|0.406
72385359|NCT00546104|144278637|SUPERIORITY_OR_OTHER||Median Difference (Net)|-0.13|STANDARD_ERROR_OF_MEAN|9.0||0.3|TWO_SIDED|95.0|-30.0|9.0||The p-value is from a paired t-test to test the null hypothesis the mean relative change in Src from baseline to 4 weeks is equal to zero.|t-test, 2 sided|||The median change in SRC from baseline to 4 weeks was estimated.||9|-30|0.3
72385360|NCT00546104|144278638|SUPERIORITY_OR_OTHER||Median Difference (Net)|-0.13|STANDARD_ERROR_OF_MEAN|0.1||0.3|TWO_SIDED|95.0|-0.3|0.1|||t-test, 1 sided|||||.10|-.30|0.3
72437653|NCT00430300|144388375|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.16||0.6391|ONE_SIDED|95.0|-0.32||||Mixed Models Analysis|||Cough, Change at Week 3: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.32|0.6391
72437654|NCT00430300|144388375|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.14||0.6838|ONE_SIDED|95.0|-0.3||||Mixed Models Analysis|||Cough, Change at Week 3: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.30|0.6838
72437655|NCT00430300|144388375|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.26|STANDARD_ERROR_OF_MEAN|0.14||0.9648|ONE_SIDED|95.0|-0.49||||Mixed Models Analysis|||Cough, Change at Week 4: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.49|0.9648
72437656|NCT00430300|144388375|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.14||0.8961|ONE_SIDED|95.0|-0.4||||Mixed Models Analysis|||Cough, Change at Week 4: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.40|0.8961
72437657|NCT00430300|144388375|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.21|STANDARD_ERROR_OF_MEAN|0.12||0.9534|ONE_SIDED|95.0|-0.41||||Mixed Models Analysis|||Cough, Change at Week 4: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.41|0.9534
72437658|NCT00430300|144388375|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.18||0.7726|ONE_SIDED|95.0|-0.45||||Mixed Models Analysis|||Cough, Change at Week 5: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.45|0.7726
72437659|NCT00430300|144388375|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.18||0.5665|ONE_SIDED|95.0|-0.33||||Mixed Models Analysis|||Cough, Change at Week 5: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.33|0.5665
72437660|NCT00430300|144388375|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.16||0.2684|ONE_SIDED|95.0|-0.17||||Mixed Models Analysis|||Cough, Change at Week 5: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.17|0.2684
72437661|NCT00430300|144388375|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.19||0.6485|ONE_SIDED|95.0|-0.39||||Mixed Models Analysis|||Cough, Change at Week 6: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.39|0.6485
72437662|NCT00430300|144388375|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.19||0.4821|ONE_SIDED|95.0|-0.3||||Mixed Models Analysis|||Cough, Change at Week 6: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.30|0.4821
72437663|NCT00430300|144388375|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.11|STANDARD_ERROR_OF_MEAN|0.16||0.2557|ONE_SIDED|95.0|-0.17||||Mixed Models Analysis|||Cough, Change at Week 6: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.17|0.2557
72437664|NCT00430300|144388375|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.23|STANDARD_ERROR_OF_MEAN|0.17||0.9031|ONE_SIDED|95.0|-0.52||||Mixed Models Analysis|||Cough, Change at Week 7: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.52|0.9031
72437665|NCT00430300|144388375|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.17||0.8634|ONE_SIDED|95.0|-0.47||||Mixed Models Analysis|||Cough, Change at Week 7: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.47|0.8634
72437666|NCT00430300|144388375|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.15||0.6375|ONE_SIDED|95.0|-0.3||||Mixed Models Analysis|||Cough, Change at Week 7: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.30|0.6375
72495163|NCT02475655|144519372|SUPERIORITY||Mean Difference (Net)|0.97||||0.95|TWO_SIDED|90.0|0.47|2.01||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib geometric mean minus No Study Treatment geometric mean. All values were log10 transformed prior to calculating change and conducting analyses and back transformed for presentation.|Null hypothesis: There is no difference between the two arms in the fold change in Interleukin 10 (IL-10) from entry to Week 12.||2.01|0.47|0.95
72437667|NCT00430300|144388375|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.21|STANDARD_ERROR_OF_MEAN|0.18||0.8775|ONE_SIDED|95.0|-0.51||||Mixed Models Analysis|||Cough, Change at Week 8: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.51|0.8775
72437668|NCT00430300|144388375|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.18||0.7191|ONE_SIDED|95.0|-0.4||||Mixed Models Analysis|||Cough, Change at Week 8: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.40|0.7191
72495164|NCT02475655|144519373|SUPERIORITY||Mean Difference (Net)|1.34||||0.002|TWO_SIDED|90.0|1.15|1.56||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib geometric mean minus No Study Treatment geometric mean. All values were log10 transformed prior to calculating change and conducting analyses and back transformed for presentation.|Null hypothesis: There is no difference between the two arms in the fold change in TInterleukin 15 (IL-15) from entry to Week 5.||1.56|1.15|0.002
72437669|NCT00430300|144388375|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.16||0.8677|ONE_SIDED|95.0|-0.44||||Mixed Models Analysis|||Cough, Change at Week 8: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.44|0.8677
72437670|NCT00430300|144388375|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.24|STANDARD_ERROR_OF_MEAN|0.11||0.9838|ONE_SIDED|95.0|-0.42||||Mixed Models Analysis|||Breathlessness, Change at Week 1: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.42|0.9838
72437671|NCT00430300|144388375|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.11||0.8106|ONE_SIDED|95.0|-0.28||||Mixed Models Analysis|||Breathlessness, Change at Week 1: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.28|0.8106
72437672|NCT00430300|144388375|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.1||0.775|ONE_SIDED|95.0|-0.23||||Mixed Models Analysis|||Breathlessness, Change at Week 1: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.23|0.7750
72437673|NCT00430300|144388375|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.13||0.8082|ONE_SIDED|95.0|-0.33||||Mixed Models Analysis|||Breathlessness, Change at Week 2: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.33|0.8082
72495165|NCT02475655|144519373|SUPERIORITY||Mean Difference (Net)|1.07||||0.6|TWO_SIDED|90.0|0.86|1.34||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib geometric mean minus No Study Treatment geometric mean. All values were log10 transformed prior to calculating change and conducting analyses and back transformed for presentation.|Null hypothesis: There is no difference between the two arms in the fold change in TInterleukin 15 (IL-15) from entry to Week 12.||1.34|0.86|0.60
72385361|NCT00573183|144278689|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.3404|STANDARD_ERROR_OF_MEAN|0.4134|<|0.05|TWO_SIDED|95.0|1.2019|9.2842||95% confidence interval|Mixed Models Analysis|A covariate adjustment was used: average number of days of stimulant use within a 30-day window of assessment from 90 days pre-baseline to baseline.|The STAGE-12 group represented the numerator and TAU represented the reference group/denominator|Mixture model with a logistic part for assessing zero-inflation and a negative binomial part for the over-dispersed count data, with corresponding 95% confidence intervals (CIs) of the odds ratios for logistic part and incidence rate ratios for negative binomial part.||9.2842|1.2019|<0.05
72385362|NCT00573183|144278689|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.4373|STANDARD_ERROR_OF_MEAN|0.4134|<|0.01|TWO_SIDED|95.0|1.0131|5.8637|||Mixed Models Analysis|||||5.8637|1.0131|<0.01
72385363|NCT00573183|144278690|SUPERIORITY_OR_OTHER||||||<|0.05||||||Statistical Model - zero-inflated negative binomial random-effects regression|Zero-inflated negative binomial random-e|Statistical Model - zero-inflated negative binomial random-effects regression adjusted for average number of days of pre-baseline attendance||Outcome measure: Number of days of self-reported Self-Help meeting attendance by the Substance Use Calendar (SUC) within a 30-day window of assessment at mid-treatment, end-of-treatment, first, second, third and last follow-ups||||<0.05
72385364|NCT01926015|144278703|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower bound of the 95% confidence interval of the percentage difference, excluding a difference \>=10%, is \>=-0.10|Difference in percentage|0.0|||<|0.001|TWO_SIDED|95.0|-3.99|3.95|||Miettinen and Nurminen|||Diphtheria Toxin \>=0.1 IU/mL||3.95|-3.99|<0.001
72437674|NCT00430300|144388375|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.13||0.7678|ONE_SIDED|95.0|-0.31||||Mixed Models Analysis|||Breathlessness, Change at Week 2: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.31|0.7678
72385365|NCT01926015|144278703|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower bound of the 95% confidence interval of the percentage difference, excluding a difference \>=10%, is \>=-0.10|Difference in percentage|0.0|||<|0.001|TWO_SIDED|95.0|-3.99|3.95|||Miettinen and Nurminen|||Tetanus Toxin \>=0.01 IU/mL||3.95|-3.99|<0.001
72385366|NCT01926015|144278703|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower bound of the 95% confidence interval of the percentage difference, excluding a difference \>=10%, is \>=-0.10|Difference in percentage|0.0|||<|0.001|TWO_SIDED|95.0|-3.99|3.95|||Miettinen and Nurminen|||Pertussis Toxin \>=10 EU/mL||3.95|-3.99|<0.001
72385367|NCT01926015|144278703|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower bound of the 95% confidence interval of the percentage difference, excluding a difference \>=10%, is \>=-0.10|Difference in percentage|0.0|||<|0.001|TWO_SIDED|95.0|-3.99|3.95|||Miettinen and Nurminen|||Pertussis FHA \>=10 EU/mL||3.95|-3.99|<0.001
72385368|NCT01926015|144278703|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower bound of the 95% confidence interval of the percentage difference, excluding a difference \>=10%, is \>=-0.10|Difference in percentage|0.0|||<|0.001|TWO_SIDED|95.0|-3.99|3.95|||Miettinen and Nurminen|||Poliovirus Type 1 NA \>=8||3.95|-3.99|<0.001
72385369|NCT01926015|144278703|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower bound of the 95% confidence interval of the percentage difference, excluding a difference \>=10%, is \>=-0.10|Difference in percentage|0.0|||<|0.001|TWO_SIDED|95.0|-3.99|3.95|||Miettinen and Nurminen|||Poliovirus Type 2 NA \>=8||3.95|-3.99|<0.001
72437675|NCT00430300|144388375|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.11||0.5373|ONE_SIDED|95.0|-0.2||||Mixed Models Analysis|||Breathlessness, Change at Week 2: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.20|0.5373
72437676|NCT00430300|144388375|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.24|STANDARD_ERROR_OF_MEAN|0.14||0.9548|ONE_SIDED|95.0|-0.47||||Mixed Models Analysis|||Breathlessness, Change at Week 3: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.47|0.9548
72437677|NCT00430300|144388375|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.27|STANDARD_ERROR_OF_MEAN|0.14||0.9743|ONE_SIDED|95.0|-0.49||||Mixed Models Analysis|||Breathlessness, Change at Week 3: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.49|0.9743
72437678|NCT00430300|144388375|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.12||0.8408|ONE_SIDED|95.0|-0.32||||Mixed Models Analysis|||Breathlessness, Change at Week 3: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.32|0.8408
72437679|NCT00430300|144388375|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.32|STANDARD_ERROR_OF_MEAN|0.14||0.9887|ONE_SIDED|95.0|-0.55||||Mixed Models Analysis|||Breathlessness, Change at Week 4: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.55|0.9887
72437680|NCT00430300|144388375|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.33|STANDARD_ERROR_OF_MEAN|0.13||0.9918|ONE_SIDED|95.0|-0.55||||Mixed Models Analysis|||Breathlessness, Change at Week 4: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.55|0.9918
72437681|NCT00430300|144388375|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.26|STANDARD_ERROR_OF_MEAN|0.12||0.9833|ONE_SIDED|95.0|-0.46||||Mixed Models Analysis|||Breathlessness, Change at Week 4: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.46|0.9833
72437682|NCT00430300|144388375|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.26|STANDARD_ERROR_OF_MEAN|0.14||0.9619|ONE_SIDED|95.0|-0.5||||Mixed Models Analysis|||Breathlessness, Change at Week 5: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.50|0.9619
72437683|NCT00430300|144388375|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.34|STANDARD_ERROR_OF_MEAN|0.14||0.9917|ONE_SIDED|95.0|-0.58||||Mixed Models Analysis|||Breathlessness, Change at Week 5: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.58|0.9917
72558599|NCT03966911|144646928|SUPERIORITY||Intercept from ANCOVA as agreement rate|84.59||||0.041|TWO_SIDED|91.8|82.02|87.17|||ANCOVA|A generalized estimating equation model was used, considering correlation structure of day of sensor wear (1-7).|A group sequential study design was utilized to perform interim analysis. For the final stage, the p-value is 0.041.|||87.17|82.02|0.041
72558600|NCT03966911|144646928|SUPERIORITY||Intercept from ANCOVA as agreement rate|81.05|||<|0.041|TWO_SIDED|91.8|77.58|84.53|||ANCOVA|A generalized estimating equation model was used, considering correlation structure of day of sensor wear (1-7).|A group sequential study design was utilized to perform interim analysis. For the final stage, the p-value is 0.041.|||84.53|77.58|<0.041
72558601|NCT01986647|144646932|SUPERIORITY_OR_OTHER|||||||0.2691|||||||Mixed Models Analysis|linear mixed model due to clustering by facility and multiple imputation for missing data||||||0.2691
72558602|NCT01986647|144646933|SUPERIORITY_OR_OTHER|||||||0.6087|||||||Mixed Models Analysis|linear mixed model due to clustering by facility and multiple imputation for missing data||||||0.6087
72558603|NCT01986647|144646934|SUPERIORITY_OR_OTHER|||||||0.0022|||||||Mixed Models Analysis|linear mixed model due to clustering by facility and multiple imputation for missing data||||||0.0022
72558604|NCT01986647|144646935|SUPERIORITY_OR_OTHER|||||||0.0344|||||||Mixed Models Analysis|linear mixed model due to clustering by facility and multiple imputation for missing data||||||0.0344
72558605|NCT01986647|144646936|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.89||||0.6879|TWO_SIDED|95.0|0.49|1.6|||Regression, Logistic|||||1.60|0.49|0.6879
72558606|NCT01986647|144646937|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.88||||0.5719|TWO_SIDED|95.0|0.56|1.37|||Regression, Logistic|||||1.37|0.56|0.5719
72437684|NCT00430300|144388375|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.12||0.9376|ONE_SIDED|95.0|-0.4||||Mixed Models Analysis|||Breathlessness, Change at Week 5: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.40|0.9376
72437685|NCT00430300|144388375|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.21|STANDARD_ERROR_OF_MEAN|0.16||0.9084|ONE_SIDED|95.0|-0.47||||Mixed Models Analysis|||Breathlessness, Change at Week 6: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.47|0.9084
72437686|NCT00430300|144388375|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.15||0.7906|ONE_SIDED|95.0|-0.38||||Mixed Models Analysis|||Breathlessness, Change at Week 6: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.38|0.7906
72558607|NCT01986647|144646938|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.56||||0.489|TWO_SIDED|95.0|0.44|5.53|||Regression, Logistic|||||5.53|0.44|0.489
72558608|NCT01986647|144646939|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.12||||0.2981|TWO_SIDED|95.0|0.37|26.6|||Regression, Logistic|||||26.6|0.37|0.2981
72558609|NCT01986647|144646940|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.06||||0.9279|TWO_SIDED|95.0|0.3|3.74|||Regression, Logistic|||||3.74|0.30|0.9279
72558610|NCT01986647|144646941|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.17||||0.5835|TWO_SIDED|95.0|0.67|2.06|||Regression, Logistic|||||2.06|0.67|0.5835
72558611|NCT01986647|144646942|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.64|STANDARD_ERROR_OF_MEAN|0.46||0.18|TWO_SIDED||||||Mixed Models Analysis|||||||0.18
72558612|NCT01986647|144646943|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.51|STANDARD_ERROR_OF_MEAN|1.42||0.73|TWO_SIDED||||||Mixed Models Analysis|||||||0.73
72558613|NCT01986647|144646944|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.11|STANDARD_ERROR_OF_MEAN|0.28||0.71|TWO_SIDED||||||Mixed Models Analysis|||||||0.71
72558614|NCT01986647|144646945|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.001|STANDARD_ERROR_OF_MEAN|0.004||0.77|TWO_SIDED||||||Mixed Models Analysis|||||||0.77
72558615|NCT01986647|144646946|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.11|STANDARD_ERROR_OF_MEAN|0.44||0.8|TWO_SIDED||||||Mixed Models Analysis|||||||0.80
72558616|NCT01986647|144646947|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.52||||0.0324|TWO_SIDED|95.0|0.29|0.95|||Regression, Logistic|||||0.95|0.29|0.0324
72558617|NCT02003391|144646991|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.6191|||<|0.0001|ONE_SIDED|95.0||-3.8503|||ANCOVA|||||-3.8503||<0.0001
72558618|NCT02272803|144646996|SUPERIORITY||Hazard Ratio (HR)|0.83|||||TWO_SIDED|95.0|0.41|1.67|||||Hazard Ratio of E-Ld to Ld. Stratified by stage of disease (International Staging System 1 - 2 vs 3)|||1.67|0.41|
72558619|NCT02302716|144647002|NON_INFERIORITY_OR_EQUIVALENCE|The primary treatment comparison was to compare LY2963016 versus Lantus at the non-inferiority margin of +0.4%. If the upper limit of the 95% confidence interval on the change from baseline to 24-week HbA1c level for LY2963016 versus Lantus was below +0.4%, then LY2963016 would be declared non-inferior to Lantus.|Mean Difference (Final Values)|-0.04||||0.693|TWO_SIDED|95.0|-0.22|0.15|||Mixed Models Analysis|||||0.15|-0.22|0.693
72558620|NCT00557245|144647014|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.33|||<|0.001|TWO_SIDED|95.0|0.19|0.56||The a priori threshold was 0.05.|Regression, Cox||Placebo arm is the reference group.|We used Cox regression stratified according to site, to estimate the relative rates of time to first positive HIV-1 serologic test.||0.56|0.19|<0.001
72558621|NCT00557245|144647014|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.25|||<|0.001|TWO_SIDED|95.0|0.13|0.45||The a priori threshold was 0.05.|Regression, Cox||Placebo arm is the reference group.|We used Cox regression stratified according to site, to estimate the relative rates of time to first positive HIV-1 serologic test.||0.45|0.13|<0.001
72558622|NCT00557245|144647015|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||||||1.00
72558623|NCT00557245|144647015|SUPERIORITY_OR_OTHER|||||||0.89|||||||Fisher Exact|||||||0.89
72558624|NCT00557245|144647019|SUPERIORITY_OR_OTHER|||||||0.24|||||||Regression, Logistic|Generalized estimating equations, with logistic link and robust standard errors to adjust for individual correlation over time.||||||0.24
72558625|NCT00557245|144647019|SUPERIORITY_OR_OTHER|||||||0.49|||||||Regression, Logistic|Generalized estimating equations, with logistic link and robust standard errors to adjust for individual correlation over time.||||||0.49
72558626|NCT00557245|144647020|SUPERIORITY_OR_OTHER|||||||0.32|||||||Regression, Logistic|Generalized estimating equations, logistic link, with robust standard errors.||||||0.32
72558627|NCT00557245|144647020|SUPERIORITY_OR_OTHER|||||||0.66|||||||Regression, Logistic|Generalized estimating equations, logistic link, with robust standard errors.||||||0.66
72437687|NCT00430300|144388375|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.14||0.8765|ONE_SIDED|95.0|-0.38||||Mixed Models Analysis|||Breathlessness, Change at Week 6: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.38|0.8765
72437688|NCT00430300|144388375|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.14||0.8469|ONE_SIDED|95.0|-0.38||||Mixed Models Analysis|||Breathlessness, Change at Week 7: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.38|0.8469
72437689|NCT00430300|144388375|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.27|STANDARD_ERROR_OF_MEAN|0.14||0.9717|ONE_SIDED|95.0|-0.5||||Mixed Models Analysis|||Breathlessness, Change at Week 7: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.50|0.9717
72437690|NCT00430300|144388375|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.12||0.7591|ONE_SIDED|95.0|-0.29||||Mixed Models Analysis|||Breathlessness, Change at Week 7: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.29|0.7591
72437691|NCT00430300|144388375|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.17||0.7141|ONE_SIDED|95.0|-0.38||||Mixed Models Analysis|||Breathlessness, Change at Week 8: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.38|0.7141
72437692|NCT00430300|144388375|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.17||0.8104|ONE_SIDED|95.0|-0.42||||Mixed Models Analysis|||Breathlessness, Change at Week 8: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.42|0.8104
72437693|NCT00430300|144388375|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.15||0.7664|ONE_SIDED|95.0|-0.35||||Mixed Models Analysis|||Breathlessness, Change at Week 8: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.35|0.7664
72437694|NCT00430300|144388375|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.12||0.7888|ONE_SIDED|95.0|-0.31||||Mixed Models Analysis|||Sputum, Change at Week 1: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.31|0.7888
72437695|NCT00430300|144388375|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.03|STANDARD_ERROR_OF_MEAN|0.12||0.393|ONE_SIDED|95.0|-0.17||||Mixed Models Analysis|||Sputum, Change at Week 1: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.17|0.3930
72437696|NCT00430300|144388375|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.11||0.4785|ONE_SIDED|95.0|-0.17||||Mixed Models Analysis|||Sputum, Change at Week 1: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.17|0.4785
72437697|NCT00430300|144388375|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.16||0.6756|ONE_SIDED|95.0|-0.34||||Mixed Models Analysis|||Sputum, Change at Week 2: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.34|0.6756
72437698|NCT00430300|144388375|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.16||0.2627|ONE_SIDED|95.0|-0.17||||Mixed Models Analysis|||Sputum, Change at Week 2: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.17|0.2627
72437699|NCT00430300|144388375|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.11|STANDARD_ERROR_OF_MEAN|0.14||0.2281|ONE_SIDED|95.0|-0.13||||Mixed Models Analysis|||Sputum, Change at Week 2: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.13|0.2281
72437700|NCT00430300|144388375|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.16||0.7656|ONE_SIDED|95.0|-0.38||||Mixed Models Analysis|||Sputum, Change at Week 3: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.38|0.7656
72437701|NCT00430300|144388375|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.13|STANDARD_ERROR_OF_MEAN|0.16||0.2105|ONE_SIDED|95.0|-0.13||||Mixed Models Analysis|||Sputum, Change at Week 3: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.13|0.2105
72437702|NCT00430300|144388375|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.11|STANDARD_ERROR_OF_MEAN|0.14||0.2221|ONE_SIDED|95.0|-0.12||||Mixed Models Analysis|||Sputum, Change at Week 3: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.12|0.2221
72437703|NCT00430300|144388375|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.02|STANDARD_ERROR_OF_MEAN|0.16||0.4396|ONE_SIDED|95.0|-0.23||||Mixed Models Analysis|||Sputum, Change at Week 4: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.23|0.4396
72437704|NCT00430300|144388375|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.11|STANDARD_ERROR_OF_MEAN|0.15||0.2243|ONE_SIDED|95.0|-0.14||||Mixed Models Analysis|||Sputum, Change at Week 4: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.14|0.2243
72437705|NCT00430300|144388375|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.05|STANDARD_ERROR_OF_MEAN|0.13||0.3597|ONE_SIDED|95.0|-0.17||||Mixed Models Analysis|||Sputum, Change at Week 4: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.17|0.3597
72558628|NCT00557245|144647021|SUPERIORITY_OR_OTHER|||||||0.51|TWO_SIDED||||||Regression, Logistic|Generalized estimating equations with logistic link to account for multiple pregnancies and multiple births||||||0.51
72558629|NCT00557245|144647021|SUPERIORITY_OR_OTHER|||||||0.86|TWO_SIDED||||||Regression, Logistic|generalized estimating equations with logistic link to account for multiple pregnancies and multiple births||||||0.86
72558630|NCT00557245|144647022|SUPERIORITY_OR_OTHER|||||||0.42|||||||Mixed Models Analysis|linear mixed-effects model||||||0.42
72558631|NCT00557245|144647022|SUPERIORITY_OR_OTHER||Slope Difference over time|0.07||||0.08|||||||Mixed Models Analysis|Linear mixed-effects model|Placebo arm is the reference group.|||||0.08
72558632|NCT00557245|144647023|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED||||||Mixed Models Analysis|Linear mixed effects model||||||0.02
72558633|NCT00557245|144647023|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|Linear mixed effects model||||||<0.001
72558634|NCT00557245|144647024|SUPERIORITY_OR_OTHER|||||||0.35|TWO_SIDED||||||Mixed Models Analysis|Linear mixed effects model||||||0.35
72558635|NCT00557245|144647024|SUPERIORITY_OR_OTHER|||||||0.008|TWO_SIDED||||||Mixed Models Analysis|Linear mixed effects model||||||0.008
72558636|NCT01127087|144647028|SUPERIORITY_OR_OTHER|||||||0.027||95.0|||||t-test, 2 sided|||Comparison of Urinary oxalate before and at the end of 4 weeks on Oxazyme in the RYGB Calcium oxalate (CaOx) Stone Formers arm.||||0.027
72558637|NCT01127087|144647028|SUPERIORITY_OR_OTHER|||||||0.14||95.0|||||t-test, 2 sided|||Comparison of Urinary oxalate before and at the end of 4 weeks on Oxazyme in the Idiopathic Hyperoxaluria CaOx Stone Formers arm.||||0.14
72558638|NCT01127087|144647029|SUPERIORITY_OR_OTHER|||||||0.018||95.0|||||t-test, 2 sided|||Comparison of Oxalate before and at the end of 4 weeks on Oxazyme in the RYGB CaOx Stone Formers arm.||||0.018
72558639|NCT01127087|144647029|SUPERIORITY_OR_OTHER|||||||0.06||95.0|||||t-test, 2 sided|||Comparison of Oxalate before and at the end of 4 weeks on Oxazyme in the Idiopathic Hyperoxaluria CaOx Stone Formers arm.||||0.06
72558640|NCT00828321|144647059|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|94.16||||||90.0|85.08|104.21|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||104.21|85.08|
72558641|NCT00828321|144647060|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|102.22||||||90.0|96.21|108.6|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||108.6|96.21|
72558642|NCT00828321|144647061|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|102.22||||||90.0|96.34|108.58|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||108.58|96.34|
72558643|NCT00828321|144647062|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|98.52||||||90.0|92.63|104.79|||||This analysis was for informational purposes and was not used to establish bioequivalence.|||104.79|92.63|
72558644|NCT00828321|144647063|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|97.45||||||90.0|94.66|100.32|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||100.32|94.66|
72558645|NCT00834964|144647069|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|97.0||||||90.0|92.72|101.49|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||101.49|92.72|
72558646|NCT00834964|144647070|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|99.7||||||90.0|94.74|104.92|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||104.92|94.74|
72558647|NCT00834964|144647071|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|98.6||||||90.0|93.46|104.02|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||104.02|93.46|
72558648|NCT00834964|144647072|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|96.29||||||90.0|91.96|100.82|||||Metabolite results not subjected to bioequivalence criteria; results are presented for informational purposes only.|||100.82|91.96|
72558649|NCT00834964|144647073|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|104.1||||||90.0|100.08|108.29|||||Metaboite results not subjected to bioequivalence criteria, results are presented for informational purposes only.|||108.29|100.08|
72558650|NCT00834964|144647074|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|100.52||||||90.0|97.3|103.84|||||Metabolite results were not subjected to bioequivalence criteria, results are presented for informational purposes only.|||103.84|97.30|
72558651|NCT01911429|144647106|SUPERIORITY_OR_OTHER||LS mean difference (SE)|-8.0||||0.0003|TWO_SIDED|95.0|-12.4|-3.7|||LS mean difference (SE)|||"The sample size was estimated to provide at least 85% power to reject at least one of the null hypotheses of no difference between placebo and lurasidone doses.~LS Mean, LS mean difference, and the associated 95% CI and p-value for change from baseline are based on Mixed Model for Repeated Measures (MMRM)."||-3.7|-12.4|0.0003
72618826|NCT06097273|144768197|SUPERIORITY|The superiority in GM level in the Cohort A1 group compared with that of Cohort A2 group was demonstrated if the lower bound of the 95% CI of the GMR was \>1.|GMR|1.641|||||TWO_SIDED|95.0|1.526|1.765||||||GMR (Cohort A1 vs Cohort A2) for SARS-CoV-2 Antibody||1.765|1.526|
72437706|NCT00430300|144388375|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.12|STANDARD_ERROR_OF_MEAN|0.14||0.203|ONE_SIDED|95.0|-0.12||||Mixed Models Analysis|||Sputum, Change at Week 5: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.12|0.2030
72437707|NCT00430300|144388375|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.16|STANDARD_ERROR_OF_MEAN|0.14||0.1207|ONE_SIDED|95.0|-0.07||||Mixed Models Analysis|||Sputum, Change at Week 5: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.07|0.1207
72437708|NCT00430300|144388375|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.11|STANDARD_ERROR_OF_MEAN|0.12||0.1836|ONE_SIDED|95.0|-0.09||||Mixed Models Analysis|||Sputum, Change at Week 5: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.09|0.1836
72437709|NCT00430300|144388375|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.12|STANDARD_ERROR_OF_MEAN|0.17||0.2359|ONE_SIDED|95.0|-0.16||||Mixed Models Analysis|||Sputum, Change at Week 6: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.16|0.2359
72437710|NCT00430300|144388375|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.09|STANDARD_ERROR_OF_MEAN|0.17||0.2861|ONE_SIDED|95.0|-0.18||||Mixed Models Analysis|||Sputum, Change at Week 6: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.18|0.2861
72437711|NCT00430300|144388375|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.12|STANDARD_ERROR_OF_MEAN|0.15||0.2151|ONE_SIDED|95.0|-0.13||||Mixed Models Analysis|||Sputum, Change at Week 6: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.13|0.2151
72437712|NCT00430300|144388375|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.06|STANDARD_ERROR_OF_MEAN|0.16||0.3545|ONE_SIDED|95.0|-0.21||||Mixed Models Analysis|||Sputum, Change at Week 7: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.21|0.3545
72437713|NCT00430300|144388375|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.16||0.7102|ONE_SIDED|95.0|-0.35||||Mixed Models Analysis|||Sputum, Change at Week 7: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.35|0.7102
72437714|NCT00430300|144388375|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.04|STANDARD_ERROR_OF_MEAN|0.14||0.3883|ONE_SIDED|95.0|-0.19||||Mixed Models Analysis|||Sputum, Change at Week 7: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.19|0.3883
72437715|NCT00430300|144388375|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.12|STANDARD_ERROR_OF_MEAN|0.16||0.2228|ONE_SIDED|95.0|-0.14||||Mixed Models Analysis|||Sputum, Change at Week 8: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.14|0.2228
72437716|NCT00430300|144388375|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.16||0.6342|ONE_SIDED|95.0|-0.32||||Mixed Models Analysis|||Sputum, Change at Week 8: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.32|0.6342
72437717|NCT00430300|144388375|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.07|STANDARD_ERROR_OF_MEAN|0.14||0.3141|ONE_SIDED|95.0|-0.16||||Mixed Models Analysis|||Sputum, Change at Week 8: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.16|0.3141
72437718|NCT00430300|144388376|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.16|STANDARD_ERROR_OF_MEAN|0.27||0.27|ONE_SIDED|95.0|-0.28||||Mixed Models Analysis|||Change at Week 1: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.28|0.2700
72437719|NCT00430300|144388376|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.24|STANDARD_ERROR_OF_MEAN|0.26||0.1831|ONE_SIDED|95.0|-0.2||||Mixed Models Analysis|||Change at Week 1: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.20|0.1831
72437720|NCT00430300|144388376|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.21|STANDARD_ERROR_OF_MEAN|0.23||0.1796|ONE_SIDED|95.0|-0.17||||Mixed Models Analysis|||Change at Week 1: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.17|0.1796
72437721|NCT00430300|144388376|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.28|STANDARD_ERROR_OF_MEAN|0.31||0.8136|ONE_SIDED|95.0|-0.79||||Mixed Models Analysis|||Change at Week 2: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.79|0.8136
72437722|NCT00430300|144388376|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.3||0.6877|ONE_SIDED|95.0|-0.66||||Mixed Models Analysis|||Change at Week 2: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.66|0.6877
72437723|NCT00430300|144388376|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.27||0.6382|ONE_SIDED|95.0|-0.54||||Mixed Models Analysis|||Change at Week 2: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.54|0.6382
72437724|NCT00430300|144388376|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.26|STANDARD_ERROR_OF_MEAN|0.36||0.766|ONE_SIDED|95.0|-0.87||||Mixed Models Analysis|||Change at Week 3: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.87|0.7660
72618827|NCT06097273|144768197|NON_INFERIORITY|The noninferiority in GM level in the Cohort A1 group compared with that of Cohort A2 group was demonstrated if the lower bound of the 97.5% CI of the GMR was \>0.667.|GMR|1.641|||||TWO_SIDED|97.5|1.51|1.783||||||GMR (Cohort A1 vs Cohort A2) for SARS-CoV-2 Antibody||1.783|1.510|
72558652|NCT01911429|144647106|SUPERIORITY_OR_OTHER||LS mean difference (SE)|-7.7||||0.0006|TWO_SIDED|95.0|-12.1|-3.4|||LS mean difference (SE)|||"The sample size was estimated to provide at least 85% power to reject at least one of the null hypotheses of no difference between placebo and lurasidone doses.~LS Mean, LS mean difference, and the associated 95% CI and p-value for change from baseline are based on Mixed Model for Repeated Measures (MMRM)."||-3.4|-12.1|0.0006
72558653|NCT01911429|144647107|SUPERIORITY_OR_OTHER||LS mean difference (SE)|-0.47||||0.0003|TWO_SIDED|95.0|-0.73|-0.22|||LS mean difference (SE)|||LS Mean, LS mean difference, and the associated 95% CI and p-value for change from baseline are based on Mixed Model for Repeated Measures (MMRM).||-0.22|-0.73|0.0003
72385370|NCT01926015|144278703|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower bound of the 95% confidence interval of the percentage difference, excluding a difference \>=10%, is \>=-0.10|Difference in percentage|0.0|||<|0.001|TWO_SIDED|95.0|-3.99|3.95|||Miettinen and Nurminen|||Poliovirus Type 3 NA \>=8||3.95|-3.99|<0.001
72437725|NCT00430300|144388376|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.21|STANDARD_ERROR_OF_MEAN|0.35||0.7226|ONE_SIDED|95.0|-0.8||||Mixed Models Analysis|||Change at Week 3: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.80|0.7226
72437726|NCT00430300|144388376|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.31||0.6634|ONE_SIDED|95.0|-0.65||||Mixed Models Analysis|||Change at Week 3: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.65|0.6634
72437727|NCT00430300|144388376|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.25|STANDARD_ERROR_OF_MEAN|0.35||0.7598|ONE_SIDED|95.0|-0.83||||Mixed Models Analysis|||Change at Week 4: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.83|0.7598
72437728|NCT00430300|144388376|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.34||0.53|ONE_SIDED|95.0|-0.59||||Mixed Models Analysis|||Change at Week 4: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.59|0.5300
72437729|NCT00430300|144388376|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.3||0.7054|ONE_SIDED|95.0|-0.66||||Mixed Models Analysis|||Change at Week 4: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.66|0.7054
72437730|NCT00430300|144388376|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.55|STANDARD_ERROR_OF_MEAN|0.45||0.8851|ONE_SIDED|95.0|-1.3||||Mixed Models Analysis|||Change at Week 5: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-1.30|0.8851
72437731|NCT00430300|144388376|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.31|STANDARD_ERROR_OF_MEAN|0.44||0.7575|ONE_SIDED|95.0|-1.05||||Mixed Models Analysis|||Change at Week 5: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-1.05|0.7575
72437732|NCT00430300|144388376|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.07|STANDARD_ERROR_OF_MEAN|0.39||0.4325|ONE_SIDED|95.0|-0.58||||Mixed Models Analysis|||Change at Week 5: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.58|0.4325
72437733|NCT00430300|144388376|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.48||0.8934|ONE_SIDED|95.0|-1.41||||Mixed Models Analysis|||Change at Week 6: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-1.41|0.8934
72437734|NCT00430300|144388376|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.47||0.5283|ONE_SIDED|95.0|-0.82||||Mixed Models Analysis|||Change at Week 6: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.82|0.5283
72437735|NCT00430300|144388376|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.41||0.49|ONE_SIDED|95.0|-0.68||||Mixed Models Analysis|||Change at Week 6: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.68|0.4900
72385371|NCT01364649|144278731|SUPERIORITY_OR_OTHER||LS mean difference|2.2|STANDARD_ERROR_OF_MEAN|0.9||0.013|TWO_SIDED|95.0|0.48|4.02|||Mixed Model Repeated Measurements|The primary analysis was performed by using observed case data only.||||4.02|0.48|0.013
72385372|NCT03423641|144278738|SUPERIORITY||Odds Ratio (OR)|0.81||||0.68|TWO_SIDED|95.0|0.3|2.2|||Marginal Structural Model||The numerator represents the DAA group while the denominator represents the comparison group for the odds ratio.|||2.20|0.30|.68
72385373|NCT03423641|144278739|SUPERIORITY||Odds Ratio (OR)|0.71||||0.01|TWO_SIDED|95.0|0.56|0.91|||Marginal Structural Model||The numerator represents the DAA group while the denominator represents the comparison group for the odds ratio.|||0.91|0.56|0.01
72385374|NCT03423641|144278740|SUPERIORITY||Odds Ratio (OR)|0.92||||0.39|TWO_SIDED|95.0|0.75|1.12|||Marginal Structural Model||The numerator represents the DAA group while the denominator represents the comparison group for the odds ratio.|||1.12|0.75|0.39
72385375|NCT03423641|144278741|SUPERIORITY||Odds Ratio (OR)|0.67||||0.01|TWO_SIDED|95.0|0.49|0.9|||Marginal Structural Model||The numerator represents the DAA group while the denominator represents the comparison group for the odds ratio.|||0.90|0.49|0.01
72437736|NCT00430300|144388376|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.34|STANDARD_ERROR_OF_MEAN|0.51||0.7465|ONE_SIDED|95.0|-1.2||||Mixed Models Analysis|||Change at Week 7: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-1.20|0.7465
72558654|NCT01911429|144647107|SUPERIORITY_OR_OTHER||LS mean difference (SE)|-0.42||||0.0015|TWO_SIDED|95.0|-0.67|-0.16|||LS mean difference (SE)|||LS Mean, LS mean difference, and the associated 95% CI and p-value for change from baseline are based on Mixed Model for Repeated Measures (MMRM).||-0.16|-0.67|0.0015
72495166|NCT02475655|144519374|SUPERIORITY||Mean Difference (Net)|0.94||||0.4|TWO_SIDED|90.0|0.82|1.07||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib geometric mean minus No Study Treatment geometric mean. All values were log10 transformed prior to calculating change and conducting analyses and back transformed for presentation.|Null hypothesis: There is no difference between the two arms in the fold change in Interleukin 18 (IL-18) from entry to Week 5.||1.07|0.82|0.40
72495167|NCT02475655|144519374|SUPERIORITY||Mean Difference (Net)|1.03||||0.82|TWO_SIDED|90.0|0.83|1.27||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib geometric mean minus No Study Treatment geometric mean. All values were log10 transformed prior to calculating change and conducting analyses and back transformed for presentation.|Null hypothesis: There is no difference between the two arms in the fold change in Interleukin 18 (IL-18) from entry to Week 12.||1.27|0.83|0.82
72495168|NCT02475655|144519375|SUPERIORITY||Mean Difference (Net)|1.5||||0.028|TWO_SIDED|90.0|1.11|2.02||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib geometric mean minus No Study Treatment geometric mean. All values were log10 transformed prior to calculating change and conducting analyses and back transformed for presentation.|Null hypothesis: There is no difference between the two arms in the fold change in Transforming Growth Factor beta 1 (TGF beta-1) from entry to Week 5.||2.02|1.11|0.028
72495169|NCT02475655|144519375|SUPERIORITY||Mean Difference (Net)|2.04||||0.21|TWO_SIDED|90.0|0.79|5.25||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib geometric mean minus No Study Treatment geometric mean. All values were log10 transformed prior to calculating change and conducting analyses and back transformed for presentation.|Null hypothesis: There is no difference between the two arms in the fold change in Transforming Growth Factor beta 1 (TGF beta-1) from entry to Week 12.||5.25|0.79|0.21
72495170|NCT02475655|144519376|SUPERIORITY||Mean Difference (Net)|1.39||||0.031|TWO_SIDED|90.0|1.08|1.79||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib geometric mean minus No Study Treatment geometric mean. All values were log10 transformed prior to calculating change and conducting analyses and back transformed for presentation.|Null hypothesis: There is no difference between the two arms in the fold change in Transforming Growth Factor beta 2 (TGF beta-2) from entry to Week 5.||1.79|1.08|0.031
72495171|NCT02475655|144519376|SUPERIORITY||Mean Difference (Net)|0.96||||0.93|TWO_SIDED|90.0|0.46|2.02||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib geometric mean minus No Study Treatment geometric mean. All values were log10 transformed prior to calculating change and conducting analyses and back transformed for presentation.|Null hypothesis: There is no difference between the two arms in the fold change in Transforming Growth Factor beta 2 (TGF beta-2) from entry to Week 12.||2.02|0.46|0.93
72495172|NCT02475655|144519377|SUPERIORITY||Mean Difference (Net)|1.57||||0.43|TWO_SIDED|90.0|0.61|4.05||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib geometric mean minus No Study Treatment geometric mean. All values were log10 transformed prior to calculating change and conducting analyses and back transformed for presentation.|Null hypothesis: There is no difference between the two arms in the fold change in Transforming Growth Factor beta 3 (TGF beta-3) from entry to Week 5.||4.05|0.61|0.43
72495173|NCT02475655|144519377|SUPERIORITY||Mean Difference (Net)|0.68||||0.41|TWO_SIDED|90.0|0.3|1.5||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib geometric mean minus No Study Treatment geometric mean. All values were log10 transformed prior to calculating change and conducting analyses and back transformed for presentation.|Null hypothesis: There is no difference between the two arms in the fold change in Transforming Growth Factor beta 3 (TGF beta-3) from entry to Week 12.||1.50|0.30|0.41
72495174|NCT02475655|144519378|SUPERIORITY||Mean Difference (Net)|-0.34||||0.038|TWO_SIDED|90.0|-0.61|-0.07||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in the expression of CD38+HLADR+ among CD4+ T-cells from Entry to Week 5.||-0.07|-0.61|0.038
72495175|NCT02475655|144519378|SUPERIORITY||Mean Difference (Net)|0.27||||0.07|TWO_SIDED|90.0|0.03|0.51||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in the expression of CD38+HLADR+ among CD4+ T-cells from Entry to Week 12.||0.51|0.03|0.07
72495176|NCT02475655|144519379|SUPERIORITY||Mean Difference (Net)|-0.88||||0.05|TWO_SIDED|90.0|-1.62|-0.13||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in the expression of CD38+HLADR+ among CD8+ T-cells from Entry to Week 5.||-0.13|-1.62|0.05
72495177|NCT02475655|144519379|SUPERIORITY||Mean Difference (Net)|0.86||||0.16|TWO_SIDED|90.0|-0.16|1.88||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in the expression of CD38+HLADR+ among CD8+ T-cells from Entry to Week 12.||1.88|-0.16|0.16
72495178|NCT02475655|144519380|SUPERIORITY||Mean Difference (Net)|-1.71|||<|0.001|TWO_SIDED|90.0|-2.46|-0.97||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in the expression of CD25hi+ among CD4+ T-cells from Entry to Week 5.||-0.97|-2.46|<0.001
72618828|NCT06097273|144768197|SUPERIORITY|The superiority in GM level in the Cohort B1 group compared with that of Cohort B2 group was demonstrated if the lower bound of the 95% CI of the GMR was \>1.|GMR|1.308|||||TWO_SIDED|95.0|1.219|1.404||||||GMR (Cohort B1 vs Cohort B2) for SARS-CoV-2 Antibody||1.404|1.219|
72385376|NCT03423641|144278742|SUPERIORITY||Odds Ratio (OR)|0.42|||<|0.01|TWO_SIDED|95.0|0.3|0.59|||Marginal Structural Model||The numerator represents the DAA group while the denominator represents the comparison group for the odds ratio.|||0.59|0.30|<0.01
72385377|NCT03423641|144278743|SUPERIORITY||Odds Ratio (OR)|0.68||||0.12|TWO_SIDED|95.0|0.42|1.1|||Marginal Structural Model||The numerator represents the DAA group while the denominator represents the comparison group for the odds ratio.|||1.10|0.42|0.12
72437737|NCT00430300|144388376|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.51||0.5848|ONE_SIDED|95.0|-0.95||||Mixed Models Analysis|||Change at Week 7: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.95|0.5848
72437738|NCT00430300|144388376|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.21|STANDARD_ERROR_OF_MEAN|0.44||0.3178|ONE_SIDED|95.0|-0.53||||Mixed Models Analysis|||Change at Week 7: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.53|0.3178
72558655|NCT01662960|144647123|SUPERIORITY|Test for the superiority of Mirror therapy over Divider therapy.|Slope|2.2||||0.443|TWO_SIDED|||||ANCOVA analysis with post-treatment score as the dependent variable, therapy type (Mirror therapy or Divider Therapy) as the independent variable, and pre-treatment score as the covariate. P-value reported is for the main effect of therapy type.|ANCOVA|||||||.443
72385378|NCT03423641|144278744|SUPERIORITY||Odds Ratio (OR)|0.61||||0.34|TWO_SIDED|95.0|0.22|1.7|||Marginal Structural Model||The numerator represents the DAA group while the denominator represents the comparison group for the odds ratio.|||1.70|0.22|0.34
72385379|NCT03423641|144278745|SUPERIORITY||Marginal Structural Model|0.61|||<|0.01|TWO_SIDED|95.0|0.49|0.76|||Marginal Structural Model||The numerator represents the DAA group while the denominator represents the comparison group for the odds ratio.|||0.76|0.49|<0.01
72385380|NCT03423641|144278746|SUPERIORITY||Rate Ratio|0.71|||<|0.01|TWO_SIDED|95.0|0.6|0.84|||Poisson Regression||The numerator represents the DAA group while the denominator represents the comparison group for the rate ratio.|||0.84|0.60|<0.01
72385381|NCT03423641|144278747|SUPERIORITY||Rate Ratio|0.82|||<|0.01|TWO_SIDED|95.0|0.77|0.87|||Poisson Regression||The numerator represents the DAA group while the denominator represents the comparison group for the rate ratio.|||0.87|0.77|<0.01
72385382|NCT03423641|144278748|SUPERIORITY||Odds Ratio (OR)|0.47||||0.02|TWO_SIDED|95.0|0.25|0.88|||Marginal Structural Model||The numerator represents the DAA group while the denominator represents the comparison group for the odds ratio.|||0.88|0.25|0.02
72385383|NCT03423641|144278749|SUPERIORITY||Odds Ratio (OR)|0.62||||0.07|TWO_SIDED|95.0|0.37|1.03|||Marginal Structural Model||The numerator represents the DAA group while the denominator represents the comparison group for the odds ratio.|||1.03|0.37|0.07
72385384|NCT03423641|144278750|SUPERIORITY||Odds Ratio (OR)|0.81||||0.11|TWO_SIDED|95.0|0.63|1.05|||Marginal Structural Model||The numerator represents the DAA group while the denominator represents the comparison group for the odds ratio.|||1.05|0.63|0.11
72385385|NCT04066647|144278756|SUPERIORITY||Mean Difference (Final Values)|0.93928821||||0.9|TWO_SIDED||||||t-test, 2 sided|2 tailed, unpaired t test with Bonferroni correction||||||0.9
72385386|NCT01914757|144278758|SUPERIORITY_OR_OTHER||Rate Ratio|0.64||||0.002|TWO_SIDED|95.0|0.49|0.85|||Negative Binomial|Model includes covariates treatment group, region, number of exacerbations in the previous year, and use of maintenance oral corticosteroids||||0.85|0.49|0.002
72385387|NCT01914757|144278758|SUPERIORITY_OR_OTHER||Rate Ratio|0.72||||0.019|TWO_SIDED|95.0|0.54|0.95|||Negative Binomial|Model includes covariates treatment group, region, number of exacerbations in the previous year, and use of maintenance oral corticosteroids.||||0.95|0.54|0.019
72385388|NCT01914757|144278759|SUPERIORITY_OR_OTHER||Rate Ratio|0.64||||0.015|TWO_SIDED|95.0|0.45|0.92|||Negative Binomial|Model includes covariates treatment group, region, number of exacerbations in the previous year, and use of maintenance oral corticosteroids||||0.92|0.45|0.015
72385389|NCT01914757|144278759|SUPERIORITY_OR_OTHER||Rate Ratio|0.6||||0.005|TWO_SIDED|95.0|0.42|0.86|||Negative Binomial|Model includes covariates treatment group, region, number of exacerbations in the previous year, and use of maintenance oral corticosteroids.||||0.86|0.42|0.005
72385390|NCT01914757|144278760|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.125||||0.005|TWO_SIDED|95.0|0.037|0.213|||Mixed Models Analysis|Model includes treatment, baseline pre-BD FEV1, region, use of OCS, visit, and treatment by visit||||0.213|0.037|0.005
72385391|NCT01914757|144278760|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.116||||0.01|TWO_SIDED|95.0|0.028|0.204|||Mixed Models Analysis|Model includes treatment, baseline pre-BD FEV1, region, use of OCS, visit, and treatment by visit||||0.204|0.028|0.01
72385392|NCT01914757|144278761|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.064||||0.268|TWO_SIDED|95.0|-0.049|0.176|||Mixed Models Analysis|Model includes treatment, baseline pre-BD FEV1, region, use of OCS, visit, and treatment by visit||||0.176|-0.049|0.268
72385393|NCT01914757|144278761|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.015||||0.786|TWO_SIDED|95.0|-0.127|0.096|||Mixed Models Analysis|Model includes treatment, baseline pre-BD FEV1, region, use of OCS, visit, and treatment by visit||||0.096|-0.127|0.786
72385394|NCT01914757|144278762|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.12||||0.224|TWO_SIDED|95.0|-0.32|0.07|||Mixed Models Analysis|Model includes treatment, baseline Asthma symptom score, region, use of OCS, visit, and visit by treatment.||||0.07|-0.32|0.224
72385395|NCT01914757|144278762|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.23||||0.019|TWO_SIDED|95.0|-0.43|-0.04|||Mixed Models Analysis|Model includes treatment, baseline Asthma symptom score, region, use of OCS, visit, and visit by treatment.||||-0.04|-0.43|0.019
72385396|NCT01914757|144278763|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.16||||0.287|TWO_SIDED|95.0|-0.44|0.13|||Mixed Models Analysis|Model includes treatment, baseline Asthma symptom score, region, use of OCS, visit, and visit by treatment.||||0.13|-0.44|0.287
72385397|NCT01914757|144278763|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01||||0.966|TWO_SIDED|95.0|-0.28|0.29|||Mixed Models Analysis|Model includes treatment, baseline Asthma symptom score, region, use of OCS, visit, and visit by treatment.||||0.29|-0.28|0.966
72385398|NCT01914757|144278764|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.21||||0.603|TWO_SIDED|95.0|-0.58|0.99|||Mixed Models Analysis|Model includes treatment, baseline Asthma rescue medication use, region, use of OCS, visit, and visit by treatment.||||0.99|-0.58|0.603
72385399|NCT01914757|144278764|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5||||0.209|TWO_SIDED|95.0|-1.29|0.28|||Mixed Models Analysis|Model includes treatment, baseline Asthma medication use, region, use of OCS, visit, and visit by treatment.||||0.28|-1.29|0.209
72558656|NCT01662960|144647124|SUPERIORITY|Test for the superiority of Mirror therapy over Divider therapy.|Slope|0.4||||0.8|TWO_SIDED|||||ANCOVA analysis with post-treatment score as the dependent variable, therapy type (Mirror therapy or Divider Therapy) as the independent variable, and pre-treatment score as the covariate. P-value reported is for the main effect of therapy type.|ANCOVA|||||||.80
72558657|NCT01662960|144647125|SUPERIORITY|Test for the superiority of Mirror therapy over Divider therapy.|Slope|-0.002||||0.93|TWO_SIDED|||||ANCOVA analysis with post-treatment score as the dependent variable, therapy type (Mirror therapy or Divider Therapy) as the independent variable, and pre-treatment score as the covariate. P-value reported is for the main effect of therapy type.|ANCOVA|||||||.93
72558658|NCT01662960|144647127|SUPERIORITY|Test for the superiority of Mirror therapy over Divider therapy.|Slope|10.7||||0.28|TWO_SIDED|||||ANCOVA analysis with post-treatment score as the dependent variable, therapy type (Mirror therapy or Divider Therapy) as the independent variable, and pre-treatment score as the covariate. P-value reported is for the main effect of therapy type.|ANCOVA|||||||.28
72558659|NCT01662960|144647128|SUPERIORITY|Test for the superiority of Mirror therapy over Divider therapy.|Slope|-0.36||||0.86|TWO_SIDED|||||ANCOVA analysis with post-treatment score as the dependent variable, therapy type (Mirror therapy or Divider Therapy) as the independent variable, and pre-treatment score as the covariate. P-value reported is for the main effect of therapy type.|ANCOVA|||||||.86
72558660|NCT01484912|144647154|NON_INFERIORITY_OR_EQUIVALENCE|The superiority testing was conducted one sided with 0.025 significance level. If H0 was rejected one-sided 0.025 significance level, STA-2 was concluded to be statistically superior to Placebo.All hypothesis testing except for the primary efficacy endpoint was conducted two sides at 0.05 significance level and 95% Confidence Interval (C.I.) was adopted if needed.||||||0.025||95.0|||||t-test, 1 sided|||T-test was used to compare the change in total exercise time between the treatment groups. The change in total exercise time (△) was defined as the total exercise time at end-point visit minus the total exercise time at baseline. Let △T be the change in total exercise time for treatment group (STA-2) and △C be the change in total exercise time for control group (Placebo). The hypothesis testing for the superiority of STA-2 to Placebo was H0：△T-△C≦0 with H1：△T-△C﹥0.||||0.025
72558661|NCT01484912|144647155|SUPERIORITY_OR_OTHER|||||||0.005||95.0|||||t-test, 2 sided|||All hypothesis testing was conducted with T-tests, two sides at 0.05 significance level and 95% Confidence Interval (C.I.) was adopted if needed.||||0.005
72558662|NCT00829452|144647245|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|96.03||||||90.0|89.11|103.49|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||103.49|89.11|
72558663|NCT00829452|144647246|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|95.34||||||90.0|90.82|100.09|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||100.09|90.82|
72558664|NCT00829452|144647247|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|96.98||||||90.0|92.73|101.42|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||101.42|92.73|
72558665|NCT00829452|144647248|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|98.78||||||90.0|89.34|109.23|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||109.23|89.34|
72558666|NCT00829452|144647249|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|97.59||||||90.0|94.62|100.66|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||100.66|94.62|
72558667|NCT02705716|144647255|OTHER||Least Square (LS) Mean Difference|-0.12||||0.5191|TWO_SIDED|95.0|-0.497|0.252|||ANCOVA|From ANCOVA Model, Response: change from baseline in Schiff sensitivity score Factors: treatment \& site Covariates: baseline Schiff sensitivity score|Difference is first named dentifrice minus second named dentifrice such that a negative difference favors first named dentifrice.|||0.252|-0.497|0.5191
72558668|NCT01395017|144647267|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.19||||0.3864|TWO_SIDED|95.0|0.85|1.65||The log-rank test was used to test OS. As a sensitivity analysis, HR and its confidence interval was also provided for OS using the Cox proportional hazard model.|Cox proportional hazard model|Adjusting for baseline factors - treatment, ECOG PS, region, CA19-9 level (\< 1000 IU/mL or \>/=1000 IU/mL), and RT during trial (yes or no).||Using a 1-sided alpha=0.2, a population of 200 participants (100 GEM plus dasatinib and 100 GEM plus placebo) has 79% power to show an increase in median OS from 10 to 13.3 months (hazard ratio \[HR\] =0.75, assuming analysis of 135 deaths).||1.65|0.85|0.3864
72558669|NCT01395017|144647268|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.99||||0.6761|TWO_SIDED|95.0|0.73|1.34||The log-rank test was used to test PFS. As a sensitivity analysis, HR and its confidence interval was also provided for PFS using the Cox proportional hazard model.|Cox proportional hazard model|Adjusting for baseline factors: treatment, ECOG PS, region, CA19-9 level (\< 1000 IU/mL or \>/=1000 IU/mL), and RT during trial (yes or no).||Trial has 88% power to show a median PFS increase from 5 to 7 months (with 1-sided alpha=0.15, total 176 events, HR=0.714).||1.34|0.73|0.6761
72558670|NCT00521586|144647376|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was to be concluded if the lower limit of the 2-sided 95% CI was greater than -0.1 or -10%|percent difference|2.8|||||TWO_SIDED|95.0|-1.8|7.4||||||A/H1N1 strain: Exact 2-sided, 95 percent (%) confidence intervals was computed based on the methodology by Chan and Zhang||7.4|-1.8|
72558671|NCT00521586|144647376|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was to be concluded if the lower limit of the 2-sided 95% CI was greater than -0.1 or -10%|percent difference|1.6|||||TWO_SIDED|95.0|-3.9|7.2||||||A/H3N2 strain: Exact 2-sided, 95 % confidence intervals was computed based on the methodology by Chan and Zhang.||7.2|-3.9|
72437739|NCT00430300|144388376|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.47|STANDARD_ERROR_OF_MEAN|0.52||0.8169|ONE_SIDED|95.0|-1.34||||Mixed Models Analysis|||Change at Week 8: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-1.34|0.8169
72437740|NCT00430300|144388376|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.23|STANDARD_ERROR_OF_MEAN|0.51||0.6727|ONE_SIDED|95.0|-1.08||||Mixed Models Analysis|||Change at Week 8: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-1.08|0.6727
72437741|NCT00430300|144388376|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.45||0.5014|ONE_SIDED|95.0|-0.75||||Mixed Models Analysis|||Change at Week 8: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.75|0.5014
72437742|NCT00430300|144388377|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-3.8|STANDARD_ERROR_OF_MEAN|6.3||0.7292|ONE_SIDED|95.0|-14.3||||Mixed Models Analysis|||Morning PEFR, Change at Week 1: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-14.3|0.7292
72437743|NCT00430300|144388377|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|3.7|STANDARD_ERROR_OF_MEAN|6.2||0.2768|ONE_SIDED|95.0|-6.6||||Mixed Models Analysis|||Morning PEFR, Change at Week 1: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-6.6|0.2768
72437744|NCT00430300|144388377|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|1.7|STANDARD_ERROR_OF_MEAN|5.4||0.3795|ONE_SIDED|95.0|-7.4||||Mixed Models Analysis|||Morning PEFR, Change at Week 1: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-7.4|0.3795
72437745|NCT00430300|144388377|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-4.9|STANDARD_ERROR_OF_MEAN|7.7||0.7374|ONE_SIDED|95.0|-17.7||||Mixed Models Analysis|||Morning PEFR, Change at Week 2: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-17.7|0.7374
72437746|NCT00430300|144388377|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-5.4|STANDARD_ERROR_OF_MEAN|7.6||0.7615|ONE_SIDED|95.0|-18.1||||Mixed Models Analysis|||Morning PEFR, Change at Week 2: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-18.1|0.7615
72437747|NCT00430300|144388377|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.4|STANDARD_ERROR_OF_MEAN|6.6||0.5811|ONE_SIDED|95.0|-12.4||||Mixed Models Analysis|||Morning PEFR, Change at Week 2: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-12.4|0.5811
72437748|NCT00430300|144388377|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-10.9|STANDARD_ERROR_OF_MEAN|8.6||0.8939|ONE_SIDED|95.0|-25.3||||Mixed Models Analysis|||Morning PEFR, Change at Week 3: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-25.3|0.8939
72437749|NCT00430300|144388377|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-7.5|STANDARD_ERROR_OF_MEAN|8.4||0.8117|ONE_SIDED|95.0|-21.6||||Mixed Models Analysis|||Morning PEFR, Change at Week 3: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-21.6|0.8117
72437750|NCT00430300|144388377|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|1.1|STANDARD_ERROR_OF_MEAN|7.4||0.4393|ONE_SIDED|95.0|-11.2||||Mixed Models Analysis|||Morning PEFR, Change at Week 3: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-11.2|0.4393
72437751|NCT00430300|144388377|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-8.5|STANDARD_ERROR_OF_MEAN|9.8||0.8055|ONE_SIDED|95.0|-24.7||||Mixed Models Analysis|||Morning PEFR, Change at Week 4: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-24.7|0.8055
72437752|NCT00430300|144388377|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-4.4|STANDARD_ERROR_OF_MEAN|9.5||0.6767|ONE_SIDED|95.0|-20.2||||Mixed Models Analysis|||Morning PEFR, Change at Week 4: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-20.2|0.6767
72437753|NCT00430300|144388377|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|2.0|STANDARD_ERROR_OF_MEAN|8.4||0.407|ONE_SIDED|95.0|-12.0||||Mixed Models Analysis|||Morning PEFR, Change at Week 4: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-12.0|0.4070
72437754|NCT00430300|144388377|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-18.6|STANDARD_ERROR_OF_MEAN|9.7||0.9705|ONE_SIDED|95.0|-34.7||||Mixed Models Analysis|||Morning PEFR, Change at Week 5: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-34.7|0.9705
72437755|NCT00430300|144388377|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-8.9|STANDARD_ERROR_OF_MEAN|9.4||0.8249|ONE_SIDED|95.0|-24.6||||Mixed Models Analysis|||Morning PEFR, Change at Week 5: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-24.6|0.8249
72437756|NCT00430300|144388377|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-12.7|STANDARD_ERROR_OF_MEAN|8.3||0.9345|ONE_SIDED|95.0|-26.6||||Mixed Models Analysis|||Morning PEFR, Change at Week 5: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-26.6|0.9345
72437757|NCT00430300|144388377|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-7.0|STANDARD_ERROR_OF_MEAN|11.0||0.7384|ONE_SIDED|95.0|-25.3||||Mixed Models Analysis|||Morning PEFR, Change at Week 6: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-25.3|0.7384
72437758|NCT00430300|144388377|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|10.7||0.5239|ONE_SIDED|95.0|-18.4||||Mixed Models Analysis|||Morning PEFR, Change at Week 6: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-18.4|0.5239
72437759|NCT00430300|144388377|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|2.0|STANDARD_ERROR_OF_MEAN|9.4||0.417|ONE_SIDED|95.0|-13.7||||Mixed Models Analysis|||Morning PEFR, Change at Week 6: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-13.7|0.4170
72437760|NCT00430300|144388377|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-7.6|STANDARD_ERROR_OF_MEAN|10.3||0.7695|ONE_SIDED|95.0|-24.8||||Mixed Models Analysis|||Morning PEFR, Change at Week 7: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-24.8|0.7695
72437761|NCT00430300|144388377|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|1.1|STANDARD_ERROR_OF_MEAN|10.1||0.4566|ONE_SIDED|95.0|-15.6||||Mixed Models Analysis|||Morning PEFR, Change at Week 7: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-15.6|0.4566
72437762|NCT00430300|144388377|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|3.3|STANDARD_ERROR_OF_MEAN|8.9||0.3535|ONE_SIDED|95.0|-11.4||||Mixed Models Analysis|||Morning PEFR, Change at Week 7: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-11.4|0.3535
72437763|NCT00430300|144388377|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-12.1|STANDARD_ERROR_OF_MEAN|11.1||0.8598|ONE_SIDED|95.0|-30.7||||Mixed Models Analysis|||Morning PEFR, Change at Week 8: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-30.7|0.8598
72437764|NCT00430300|144388377|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-9.2|STANDARD_ERROR_OF_MEAN|10.9||0.8005|ONE_SIDED|95.0|-27.4||||Mixed Models Analysis|||Morning PEFR, Change at Week 8: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-27.4|0.8005
72437765|NCT00430300|144388377|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|3.9|STANDARD_ERROR_OF_MEAN|9.6||0.3441|ONE_SIDED|95.0|-12.2||||Mixed Models Analysis|||Morning PEFR, Change at Week 8: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-12.2|0.3441
72558672|NCT00521586|144647376|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was to be concluded if the lower limit of the 2-sided 95% CI was greater than -0.1 or -10%|percent difference|0.3|||||TWO_SIDED|95.0|-5.6|6.2||||||B strain: Exact 2-sided, 95 % confidence intervals was computed based on the methodology by Chan and Zhang.||6.2|-5.6|
72558673|NCT00521586|144647377|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was to be concluded if the lower limit of the 2-sided 95% CI for the GMR was greater than 0.5 (2-fold criterion).|Geometric mean ratio|0.74|||||TWO_SIDED|95.0|0.58|0.95||||||Serotype 1: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution.||0.95|0.58|
72437766|NCT00430300|144388377|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|1.0|STANDARD_ERROR_OF_MEAN|6.9||0.4436|ONE_SIDED|95.0|-10.5||||Mixed Models Analysis|||Evening PEFR, Change at Week 1: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-10.5|0.4436
72437767|NCT00430300|144388377|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-4.1|STANDARD_ERROR_OF_MEAN|6.8||0.7238|ONE_SIDED|95.0|-15.5||||Mixed Models Analysis|||Evening PEFR, Change at Week 1: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-15.5|0.7238
72437768|NCT00430300|144388377|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|6.0||0.5743|ONE_SIDED|95.0|-11.1||||Mixed Models Analysis|||Evening PEFR, Change at Week 1: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-11.1|0.5743
72437769|NCT00430300|144388377|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-3.0|STANDARD_ERROR_OF_MEAN|9.8||0.619|ONE_SIDED|95.0|-19.3||||Mixed Models Analysis|||Evening PEFR, Change at Week 2: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-19.3|0.6190
72437770|NCT00430300|144388377|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-15.9|STANDARD_ERROR_OF_MEAN|9.7||0.9473|ONE_SIDED|95.0|-32.1||||Mixed Models Analysis|||Evening PEFR, Change at Week 2: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-32.1|0.9473
72437771|NCT00430300|144388377|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-7.3|STANDARD_ERROR_OF_MEAN|8.5||0.8014|ONE_SIDED|95.0|-21.4||||Mixed Models Analysis|||Evening PEFR, Change at Week 2: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-21.4|0.8014
72437772|NCT00430300|144388377|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-7.1|STANDARD_ERROR_OF_MEAN|8.6||0.7929|ONE_SIDED|95.0|-21.5||||Mixed Models Analysis|||Evening PEFR, Change at Week 3: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-21.5|0.7929
72437773|NCT00430300|144388377|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-23.2|STANDARD_ERROR_OF_MEAN|8.4||0.9963|ONE_SIDED|95.0|-37.3||||Mixed Models Analysis|||Evening PEFR, Change at Week 3: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-37.3|0.9963
72437774|NCT00430300|144388377|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-4.8|STANDARD_ERROR_OF_MEAN|7.4||0.7387|ONE_SIDED|95.0|-17.1||||Mixed Models Analysis|||Evening PEFR, Change at Week 3: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-17.1|0.7387
72437775|NCT00430300|144388377|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-2.8|STANDARD_ERROR_OF_MEAN|8.4||0.6286|ONE_SIDED|95.0|-16.8||||Mixed Models Analysis|||Evening PEFR, Change at Week 4: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-16.8|0.6286
72437776|NCT00430300|144388377|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-14.1|STANDARD_ERROR_OF_MEAN|8.3||0.9538|ONE_SIDED|95.0|-27.8||||Mixed Models Analysis|||Evening PEFR, Change at Week 4: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-27.8|0.9538
72437777|NCT00430300|144388377|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.3|STANDARD_ERROR_OF_MEAN|7.3||0.5701|ONE_SIDED|95.0|-13.4||||Mixed Models Analysis|||Evening PEFR, Change at Week 4: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-13.4|0.5701
72437778|NCT00430300|144388377|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-14.5|STANDARD_ERROR_OF_MEAN|10.0||0.9242|ONE_SIDED|95.0|-31.3||||Mixed Models Analysis|||Evening PEFR, Change at Week 5: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-31.3|0.9242
72437779|NCT00430300|144388377|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-22.4|STANDARD_ERROR_OF_MEAN|9.8||0.9876|ONE_SIDED|95.0|-38.8||||Mixed Models Analysis|||Evening PEFR, Change at Week 5: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-38.8|0.9876
72437780|NCT00430300|144388377|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-18.1|STANDARD_ERROR_OF_MEAN|8.7||0.9802|ONE_SIDED|95.0|-32.5||||Mixed Models Analysis|||Evening PEFR, Change at Week 5: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-32.5|0.9802
72437781|NCT00430300|144388377|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.9|STANDARD_ERROR_OF_MEAN|10.6||0.5705|ONE_SIDED|95.0|-19.5||||Mixed Models Analysis|||Evening PEFR, Change at Week 6: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-19.5|0.5705
72495179|NCT02475655|144519380|SUPERIORITY||Mean Difference (Net)|0.16||||0.68|TWO_SIDED|90.0|-0.5|0.82||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in the expression of CD25hi+ among CD4+ T-cells from Entry to Week 12.||0.82|-0.50|0.68
72495180|NCT02475655|144519381|SUPERIORITY||Mean Difference (Net)|-0.01||||0.98|TWO_SIDED|90.0|-0.7|0.69||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in the expression of CD25+ among CD8+ T-cells from Entry to Week 5.||0.69|-0.70|0.98
72495181|NCT02475655|144519381|SUPERIORITY||Mean Difference (Net)|-0.16||||0.79|TWO_SIDED|90.0|-1.13|0.82||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in the expression of CD25+ among CD8+ T-cells from Entry to Week 12.||0.82|-1.13|0.79
72618829|NCT06097273|144768197|NON_INFERIORITY|The noninferiority in GM level in the Cohort B1 group compared with that of Cohort B2 group was demonstrated if the lower bound of the 97.5% CI of the GMR was \>0.667.|GMR|1.308|||||TWO_SIDED|97.5|1.207|1.418||||||GMR (Cohort B1 vs Cohort B2) for SARS-CoV-2 Antibody||1.418|1.207|
72437782|NCT00430300|144388377|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-9.0|STANDARD_ERROR_OF_MEAN|10.3||0.8063|ONE_SIDED|95.0|-26.1||||Mixed Models Analysis|||Evening PEFR, Change at Week 6: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-26.1|0.8063
72437783|NCT00430300|144388377|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-3.9|STANDARD_ERROR_OF_MEAN|9.1||0.6667|ONE_SIDED|95.0|-19.1||||Mixed Models Analysis|||Evening PEFR, Change at Week 6: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-19.1|0.6667
72437784|NCT00430300|144388377|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.9|STANDARD_ERROR_OF_MEAN|10.4||0.464|ONE_SIDED|95.0|-16.4||||Mixed Models Analysis|||Evening PEFR, Change at Week 7: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-16.4|0.4640
72437785|NCT00430300|144388377|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-12.2|STANDARD_ERROR_OF_MEAN|10.2||0.8821|ONE_SIDED|95.0|-29.3||||Mixed Models Analysis|||Evening PEFR, Change at Week 7: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-29.3|0.8821
72437786|NCT00430300|144388377|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-6.4|STANDARD_ERROR_OF_MEAN|9.0||0.7591|ONE_SIDED|95.0|-21.4||||Mixed Models Analysis|||Evening PEFR, Change at Week 7: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-21.4|0.7591
72437787|NCT00430300|144388377|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|2.8|STANDARD_ERROR_OF_MEAN|11.0||0.4001|ONE_SIDED|95.0|-15.6||||Mixed Models Analysis|||Evening PEFR, Change at Week 8: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-15.6|0.4001
72437788|NCT00430300|144388377|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-12.3|STANDARD_ERROR_OF_MEAN|10.8||0.8707|ONE_SIDED|95.0|-30.3||||Mixed Models Analysis|||Evening PEFR, Change at Week 8: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-30.3|0.8707
72437789|NCT00430300|144388377|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.9|STANDARD_ERROR_OF_MEAN|9.6||0.4629|ONE_SIDED|95.0|-15.0||||Mixed Models Analysis|||Evening PEFR, Change at Week 8: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-15.0|0.4629
72437790|NCT00430300|144388378|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.6428|||||TWO_SIDED|95.0|0.2023|2.0419||||||A proportional odds model was fitted using Proc Logistic in Statistical Analysis System (SAS), using treatment as a categorical variable and center as a covariate. The odds ratio and corresponding 95% confidence interval were tested using Type III (Wald) tests.||2.0419|0.2023|
72437791|NCT00430300|144388378|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.5574|||||TWO_SIDED|95.0|0.1505|2.0647||||||A proportional odds model was fitted using Proc Logistic in SAS, using treatment as a categorical variable and center as a covariate. The odds ratio and corresponding 95% confidence interval were tested using Type III (Wald) tests.||2.0647|0.1505|
72437792|NCT00430300|144388378|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.327|||||TWO_SIDED|95.0|0.083|1.2879||||||A proportional odds model was fitted using Proc Logistic in SAS, using treatment as a categorical variable and center as a covariate. The odds ratio and corresponding 95% confidence interval were tested using Type III (Wald) tests.||1.2879|0.0830|
72437793|NCT00430300|144388379|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.5709|||||TWO_SIDED|95.0|0.179|1.8204||||||A proportional odds model was fitted using Proc Logistic in SAS, using treatment as a categorical variable and center as a covariate. The odds ratio and corresponding 95% confidence interval were tested using Type III (Wald) tests.||1.8204|0.1790|
72437794|NCT00430300|144388379|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.6416|||||TWO_SIDED|95.0|0.1736|2.3715||||||A proportional odds model was fitted using Proc Logistic in SAS, using treatment as a categorical variable and center as a covariate. The odds ratio and corresponding 95% confidence interval were tested using Type III (Wald) tests.||2.3715|0.1736|
72437795|NCT00430300|144388379|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.5877|||||TWO_SIDED|95.0|0.1516|2.2777||||||A proportional odds model was fitted using Proc Logistic in SAS, using treatment as a categorical variable and center as a covariate. The odds ratio and corresponding 95% confidence interval were tested using Type III (Wald) tests.||2.2777|0.1516|
72437796|NCT02666742|144388387|SUPERIORITY|Continuous variables were compared by two-sample t-tests and categorical variables by chi-square test. All tests were two-tailed, and a P value less than 0.05 was considered to indicate statistical significance. Bonferroni correction was not performed due to prespecified outcomes in the trial. Analyses were performed using GraphPad 6||||||0.001|||||||Chi-squared|||Due to lack of precedent robust clinical data, we performed exploratory study to evaluate safety and efficacy of DOAC vs. Aspirin (ASA) in patients undergoing left ventricular arrhythmia (LVA) ablation; therefore, sample size calculation was not undertaken.||||0.001
72437797|NCT01063517|144388419|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.8|||||TWO_SIDED|80.0|0.62|1.03|||||The numerator of the hazard ratio is hazards of progression in olaparib+paclitaxel group and denominator is hazards of progression in placebo+paclitaxel group. Confidence intervals are calculated using the profile-likelihood method.|The analysis was performed using a Cox proportional hazards model with factors for treatment group, ATM status and gastrectomy (full, partial, none).||1.03|0.62|
72558674|NCT00521586|144647377|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was to be concluded if the lower limit of the 2-sided 95% CI for the GMR was greater than 0.5 (2-fold criterion).|Geometric mean ratio|0.79|||||TWO_SIDED|95.0|0.66|0.93||||||Serotype 3: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution.||0.93|0.66|
72558675|NCT00521586|144647377|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was to be concluded if the lower limit of the 2-sided 95% CI for the GMR was greater than 0.5 (2-fold criterion).|Geometric mean ratio|0.69|||||TWO_SIDED|95.0|0.55|0.87||||||Serotype 4: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution.||0.87|0.55|
72437798|NCT01063517|144388420|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.74|||||TWO_SIDED|80.0|0.51|1.08|||||The numerator of the hazard ratio is hazards of progression in olaparib+paclitaxel group and denominator is hazards of progression in placebo+paclitaxel group. Confidence intervals are calculated using the profile-likelihood method.|The analysis was performed using a Cox proportional hazards model with factors for treatment group and gastrectomy (full, partial, none).||1.08|0.51|
72437799|NCT01063517|144388421|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.56|||||TWO_SIDED|80.0|0.41|0.75|||||The numerator of the hazard ratio is hazards of death in olaparib+paclitaxel group and denominator is hazards of death in placebo+paclitaxel group. Confidence intervals are calculated using the profile-likelihood method.|The analysis was performed using a Cox proportional hazards model with factors for treatment group, ATM status and gastrectomy (full, partial, none).||0.75|0.41|
72437800|NCT01063517|144388422|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.35|||||TWO_SIDED|80.0|0.22|0.56|||||The numerator of the hazard ratio is hazards of death in olaparib+paclitaxel group and denominator is hazards of death in placebo+paclitaxel group. Confidence intervals are calculated using the profile-likelihood method.|The analysis was performed using a Cox proportional hazards model with factors for treatment group and gastrectomy (full, partial, none).||0.56|0.22|
72437801|NCT00546871|144388462|SUPERIORITY_OR_OTHER_LEGACY||Poisson|0.067|||||ONE_SIDED|99.0||0.134||||||||0.134||
72437802|NCT04411082|144388484|SUPERIORITY||||||>|0.99|||||||Fisher Exact|||||||>0.99
72437803|NCT04411082|144388485|SUPERIORITY||||||>|0.99|||||||Fisher Exact|||||||>0.99
72437804|NCT04411082|144388486|SUPERIORITY||||||>|0.99|||||||Fisher Exact|||||||>0.99
72437805|NCT04411082|144388487|SUPERIORITY||||||>|0.4839|||||||Fisher Exact|||||||>0.4839
72437806|NCT04411082|144388488|SUPERIORITY|||||||0.2065|||||||Fisher Exact|||||||0.2065
72437807|NCT04411082|144388489|SUPERIORITY|||||||0.4839|||||||Fisher Exact|||||||0.4839
72437808|NCT04411082|144388490|SUPERIORITY||||||>|0.99|||||||Fisher Exact|||||||>0.99
72437809|NCT04411082|144388491|SUPERIORITY||||||>|0.99|||||||Fisher Exact|||||||>0.99
72437810|NCT03762668|144388496|NON_INFERIORITY|Noninferiority in VA was declared if the Upper Confidence Limit was less than 0.05.|Least Squares Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.005|||ONE_SIDED|95.0||0.01|||mixed effects repeated measures model||test minus control|||0.01||
72437811|NCT02027558|144388497|SUPERIORITY||Mean Difference (Net)|-3.21|STANDARD_ERROR_OF_MEAN|0.7|<|0.001|TWO_SIDED|95.0|-4.58|-1.83|||Mixed Models Analysis||The parameter estimate is the improvement in the outcome from baseline to 3-months for the treatment group versus the same improvement in respect to the control group.|||-1.83|-4.58|<.001
72437812|NCT02027558|144388498|SUPERIORITY||Mean Difference (Net)|-16.23|STANDARD_ERROR_OF_MEAN|6.52||0.013|TWO_SIDED|95.0|-29.02|-2.49|||Mixed Models Analysis||The parameter estimate is the improvement in the outcome from baseline to 3-months for the treatment group versus the same improvement in respect to the control group.|||-2.49|-29.02|0.013
72437813|NCT02027558|144388499|SUPERIORITY||Mean Difference (Net)|-20.46|STANDARD_ERROR_OF_MEAN|8.75||0.019|TWO_SIDED|95.0|-37.63|-3.29|||Mixed Models Analysis||The parameter estimate is the improvement in the outcome from baseline to 3-months for the treatment group versus the same improvement in respect to the control group.|||-3.29|-37.63|0.019
72437814|NCT02027558|144388500|SUPERIORITY||Mean Difference (Net)|10.49|STANDARD_ERROR_OF_MEAN|3.04||0.001|TWO_SIDED|95.0|4.53|16.44|||Mixed Models Analysis||The parameter estimate is the improvement in the outcome from baseline to 3-months for the treatment group versus the same improvement in respect to the control group.|||16.44|4.53|0.001
72558676|NCT00521586|144647377|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was to be concluded if the lower limit of the 2-sided 95% CI for the GMR was greater than 0.5 (2-fold criterion).|Geometric mean ratio|0.84|||||TWO_SIDED|95.0|0.67|1.05||||||Serotype 5: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution.||1.05|0.67|
72437815|NCT02027558|144388501|SUPERIORITY||Mean Difference (Net)|4.35|STANDARD_ERROR_OF_MEAN|1.26||0.001|TWO_SIDED|95.0|1.87|6.83|||Mixed Models Analysis||The parameter estimate is the improvement in the outcome from baseline to 3-months for the treatment group versus the same improvement in respect to the control group.|||6.83|1.87|0.001
72437816|NCT02027558|144388502|SUPERIORITY||Mean Difference (Final Values)|-17.42|STANDARD_ERROR_OF_MEAN|4.99||0.0007|TWO_SIDED|95.0|-27.29|-7.55|||t-test, 2 sided|||||-7.55|-27.29|0.0007
72437817|NCT02296424|144388544|EQUIVALENCE|nominal 2.5% two-sided significance level was expected to have 90% powe to detect a difference between the Null Hypothesis proportion of patients who remain at their dose level.||||||0.0001|||||||exact binomial test|||||||0.0001
72437818|NCT04956575|144388604|OTHER|The ratio of GMT was estimated by the ratio of model based GMT.|Ratio|1.82|||||TWO_SIDED|95.0|1.27|2.61|||||The 2 sided 95% assessed the difference in immune response between the mRNA-1010 compared with the active comparator, Afluria Quadrivalent, at Day 29.|Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against H1N1 at Day 29.||2.61|1.27|
72437819|NCT04956575|144388604|OTHER|The ratio of GMT was estimated by the ratio of model based GMT.|Ratio|2.57|||||TWO_SIDED|95.0|1.79|3.7|||||The 2 sided 95% assessed the difference in immune response between the mRNA-1010 compared with the active comparator, Afluria Quadrivalent, at Day 29.|Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against H1N1 at Day 29.||3.70|1.79|
72437820|NCT04956575|144388604|OTHER|The ratio of GMT was estimated by the ratio of model based GMT.|Ratio|2.7|||||TWO_SIDED|95.0|1.88|3.88|||||The 2 sided 95% assessed the difference in immune response between the mRNA-1010 compared with the active comparator, Afluria Quadrivalent, at Day 29.|Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against H1N1 at Day 29.||3.88|1.88|
72437821|NCT04956575|144388604|OTHER|The ratio of GMT was estimated by the ratio of model based GMT.|Ratio|1.79|||||TWO_SIDED|95.0|1.29|2.5|||||The 2 sided 95% assessed the difference in immune response between the mRNA-1010 compared with the active comparator, Afluria Quadrivalent, at Day 29.|Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against H3N2 at Day 29.||2.50|1.29|
72437822|NCT04956575|144388604|OTHER|The ratio of GMT was estimated by the ratio of model based GMT.|Ratio|2.19|||||TWO_SIDED|95.0|1.57|3.05|||||The 2 sided 95% assessed the difference in immune response between the mRNA-1010 compared with the active comparator, Afluria Quadrivalent, at Day 29.|Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against H3N2 at Day 29.||3.05|1.57|
72437823|NCT04956575|144388604|OTHER|The ratio of GMT was estimated by the ratio of model based GMT.|Ratio|2.52|||||TWO_SIDED|95.0|1.81|3.5|||||The 2 sided 95% assessed the difference in immune response between the mRNA-1010 compared with the active comparator, Afluria Quadrivalent, at Day 29.|Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against H3N2 at Day 29.||3.50|1.81|
72437824|NCT04956575|144388604|OTHER|The ratio of GMT was estimated by the ratio of model based GMT.|Ratio|0.68|||||TWO_SIDED|95.0|0.54|0.87|||||The 2 sided 95% assessed the difference in immune response between the mRNA-1010 compared with the active comparator, Afluria Quadrivalent, at Day 29.|Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against Victoria-lineage at Day 29.||0.87|0.54|
72437825|NCT04956575|144388604|OTHER|The ratio of GMT was estimated by the ratio of model based GMT.|Ratio|0.88|||||TWO_SIDED|95.0|0.69|1.12|||||The 2 sided 95% assessed the difference in immune response between the mRNA-1010 compared with the active comparator, Afluria Quadrivalent, at Day 29.|Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against Victoria-lineage at Day 29.||1.12|0.69|
72437826|NCT04956575|144388604|OTHER|The ratio of GMT was estimated by the ratio of model based GMT.|Ratio|0.84|||||TWO_SIDED|95.0|0.66|1.06|||||The 2 sided 95% assessed the difference in immune response between the mRNA-1010 compared with the active comparator, Afluria Quadrivalent, at Day 29.|Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against Victoria-lineage at Day 29.||1.06|0.66|
72437827|NCT04956575|144388604|OTHER|The ratio of GMT was estimated by the ratio of model based GMT.|Ratio|1.11|||||TWO_SIDED|95.0|0.86|1.44|||||The 2 sided 95% assessed the difference in immune response between the mRNA-1010 compared with the active comparator, Afluria Quadrivalent, at Day 29.|Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against Yamagata-lineage at Day 29.||1.44|0.86|
72437828|NCT04956575|144388604|OTHER|The ratio of GMT was estimated by the ratio of model based GMT.|Ratio|1.19|||||TWO_SIDED|95.0|0.93|1.54|||||The 2 sided 95% assessed the difference in immune response between the mRNA-1010 compared with the active comparator, Afluria Quadrivalent, at Day 29.|Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against Yamagata-lineage at Day 29.||1.54|0.93|
72558677|NCT00521586|144647377|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was to be concluded if the lower limit of the 2-sided 95% CI for the GMR was greater than 0.5 (2-fold criterion).|Geometric mean ratio|0.86|||||TWO_SIDED|95.0|0.7|1.06||||||Serotype 6A: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution.||1.06|0.70|
72437829|NCT04956575|144388604|OTHER|The ratio of GMT was estimated by the ratio of model based GMT.|Ratio|1.2|||||TWO_SIDED|95.0|0.93|1.55|||||The 2 sided 95% assessed the difference in immune response between the mRNA-1010 compared with the active comparator, Afluria Quadrivalent, at Day 29.|Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against Yamagata-lineage at Day 29.||1.55|0.93|
72437830|NCT04956575|144388605|OTHER|The ratio of GMT was estimated by the ratio of model based GMT.|Ratio|0.9|||||TWO_SIDED|95.0|0.57|1.44|||||The 2 sided 95% assessed the difference in immune response between the mRNA-1010 compared with the active comparator, Afluria Quadrivalent, at Day 29.|Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against H1N1 at Day 29.||1.44|0.57|
72437831|NCT04956575|144388605|OTHER|The ratio of GMT was estimated by the ratio of model based GMT.|Ratio|1.25|||||TWO_SIDED|95.0|0.78|2.0|||||The 2 sided 95% assessed the difference in immune response between the mRNA-1010 compared with the active comparator, Afluria Quadrivalent, at Day 29.|Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against H1N1 at Day 29.||2.00|0.78|
72437832|NCT04956575|144388605|OTHER|The ratio of GMT was estimated by the ratio of model based GMT.|Ratio|1.86|||||TWO_SIDED|95.0|1.16|2.99|||||The 2 sided 95% assessed the difference in immune response between the mRNA-1010 compared with the active comparator, Afluria Quadrivalent, at Day 29.|Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent. against H1N1 at Day 29.||2.99|1.16|
72437833|NCT04956575|144388605|OTHER|The ratio of GMT was estimated by the ratio of model based GMT.|Ratio|1.41|||||TWO_SIDED|95.0|0.91|2.21|||||The 2 sided 95% assessed the difference in immune response between the mRNA-1010 compared with the active comparator, Afluria Quadrivalent, at Day 29.|Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against H3N2 at Day 29.||2.21|0.91|
72437834|NCT04956575|144388605|OTHER|The ratio of GMT was estimated by the ratio of model based GMT.|Ratio|1.89|||||TWO_SIDED|95.0|1.21|2.97|||||The 2 sided 95% assessed the difference in immune response between the mRNA-1010 compared with the active comparator, Afluria Quadrivalent, at Day 29.|Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against H3N2 at Day 29.||2.97|1.21|
72437835|NCT04956575|144388605|OTHER|The ratio of GMT was estimated by the ratio of model based GMT.|Ratio|2.64|||||TWO_SIDED|95.0|1.68|4.14|||||The 2 sided 95% assessed the difference in immune response between the mRNA-1010 compared with the active comparator, Afluria Quadrivalent, at Day 29.|Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against H3N2 at Day 29.||4.14|1.68|
72437836|NCT04956575|144388605|OTHER|The ratio of GMT was estimated by the ratio of model based GMT.|Ratio|0.36|||||TWO_SIDED|95.0|0.26|0.5|||||The 2 sided 95% assessed the difference in immune response between the mRNA-1010 compared with the active comparator, Afluria Quadrivalent, at Day 29.|Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against Victoria-lineage at Day 29.||0.50|0.26|
72495182|NCT02475655|144519382|SUPERIORITY||Mean Difference (Net)|3.49||||0.001|TWO_SIDED|90.0|1.75|5.22||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in the expression of CD127+ among CD4+ T-cells from Entry to Week 5.||5.22|1.75|0.001
72495183|NCT02475655|144519382|SUPERIORITY||Mean Difference (Net)|-1.3||||0.28|TWO_SIDED|90.0|-3.28|0.68||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.||Null hypothesis: There is no difference between the two arms in the change in the expression of CD127+ among CD4+ T-cells from Entry to Week 12.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|0.68|-3.28|0.28
72437837|NCT04956575|144388605|OTHER|The ratio of GMT was estimated by the ratio of model based GMT.|Ratio|0.46|||||TWO_SIDED|95.0|0.33|0.64|||||The 2 sided 95% assessed the difference in immune response between the mRNA-1010 compared with the active comparator, Afluria Quadrivalent, at Day 29.|Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against Victoria-lineage at Day 29.||0.64|0.33|
72437838|NCT04956575|144388605|OTHER|The ratio of GMT was estimated by the ratio of model based GMT.|Ratio|0.54|||||TWO_SIDED|95.0|0.38|0.76|||||The 2 sided 95% assessed the difference in immune response between the mRNA-1010 compared with the active comparator, Afluria Quadrivalent, at Day 29.|Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against Victoria-lineage at Day 29.||0.76|0.38|
72437839|NCT04956575|144388605|OTHER|The ratio of GMT was estimated by the ratio of model based GMT.|Ratio|0.62|||||TWO_SIDED|95.0|0.43|0.9|||||The 2 sided 95% assessed the difference in immune response between the mRNA-1010 compared with the active comparator, Afluria Quadrivalent, at Day 29.|Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against Yamagata-lineage at Day 29.||0.90|0.43|
72437840|NCT04956575|144388605|OTHER|The ratio of GMT was estimated by the ratio of model based GMT.|Ratio|0.92|||||TWO_SIDED|95.0|0.63|1.35|||||The 2 sided 95% assessed the difference in immune response between the mRNA-1010 compared with the active comparator, Afluria Quadrivalent, at Day 29.|Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against Yamagata-lineage at Day 29.||1.35|0.63|
72437841|NCT04956575|144388605|OTHER|The ratio of GMT was estimated by the ratio of model based GMT.|Ratio|0.75|||||TWO_SIDED|95.0|0.51|1.09|||||The 2 sided 95% assessed the difference in immune response between the mRNA-1010 compared with the active comparator, Afluria Quadrivalent, at Day 29.|Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against Yamagata-lineage at Day 29.||1.09|0.51|
72437842|NCT04956575|144388608|OTHER||Percent difference|12.61|||||TWO_SIDED|95.0|-2.0|27.93|||||Seroconversion percent difference of mRNA-1010 - Afluria Quadrivalent. 95% CI was calculated using the Miettinen-Nurminen (score) method.|Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against H1N1 at Day 29.||27.93|-2.00|
72437843|NCT04956575|144388608|OTHER||Percent difference|25.17|||||TWO_SIDED|95.0|11.18|39.89|||||Seroconversion percent difference of mRNA-1010 - Afluria Quadrivalent. 95% CI was calculated using the Miettinen-Nurminen (score) method.|Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against H1N1 at Day 29.||39.89|11.18|
72437844|NCT04956575|144388608|OTHER||Percent Difference|26.2|||||TWO_SIDED|95.0|12.33|40.84|||||Seroconversion percent difference of mRNA-1010 - Afluria Quadrivalent. 95% CI was calculated using the Miettinen-Nurminen (score) method.|Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against H1N1 at Day 29.||40.84|12.33|
72437845|NCT04956575|144388608|OTHER||Percent Difference|25.59|||||TWO_SIDED|95.0|9.82|40.13|||||Seroconversion percent difference of mRNA-1010 - Afluria Quadrivalent. 95% CI was calculated using the Miettinen-Nurminen (score) method.|Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against H3N2 at Day 29.||40.13|9.82|
72437846|NCT04956575|144388608|OTHER||Percent Difference|31.35|||||TWO_SIDED|95.0|15.66|45.73|||||Seroconversion percent difference of mRNA-1010 - Afluria Quadrivalent. 95% CI was calculated using the Miettinen-Nurminen (score) method.|Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against H3N2 at Day 29.||45.73|15.66|
72495184|NCT02475655|144519383|SUPERIORITY||Mean Difference (Net)|6.54|||<|0.001|TWO_SIDED|90.0|3.76|9.31||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in the expression of CD127+ among CD8+ T-cells from Entry to Week 5.||9.31|3.76|<0.001
72495185|NCT02475655|144519383|SUPERIORITY||Mean Difference (Net)|-0.19||||0.92|TWO_SIDED|90.0|-3.56|3.18||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in the expression of CD127+ among CD8+ T-cells from Entry to Week 12.||3.18|-3.56|0.92
72495186|NCT02475655|144519384|SUPERIORITY||Mean Difference (Net)|-0.07||||0.82|TWO_SIDED|90.0|-0.61|0.47||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in the expression of Ki67+ among CD4+ T-cells from Entry to Week 5.||0.47|-0.61|0.82
72495187|NCT02475655|144519384|SUPERIORITY||Mean Difference (Net)|0.76||||0.033|TWO_SIDED|90.0|0.18|1.34||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in the expression of Ki67+ among CD4+ T-cells from Entry to Week 12.||1.34|0.18|0.033
72495188|NCT02475655|144519385|SUPERIORITY||Mean Difference (Net)|0.01||||0.98|TWO_SIDED|90.0|-0.53|0.55||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in the expression of Ki67+ among CD8+ T-cells from Entry to Week 5.||0.55|-0.53|0.98
72495189|NCT02475655|144519385|SUPERIORITY||Mean Difference (Net)|0.55||||0.37|TWO_SIDED|90.0|-0.46|1.57||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in the expression of Ki67+ among CD8+ T-cells from Entry to Week 12.||1.57|-0.46|0.37
72495190|NCT02475655|144519386|SUPERIORITY||Mean Difference (Net)|-3.3|||<|0.001|TWO_SIDED|90.0|-4.72|-1.87||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in the expression of Bcl2+ among CD4+ T-cells from Entry to Week 5.||-1.87|-4.72|<0.001
72495191|NCT02475655|144519386|SUPERIORITY||Mean Difference (Net)|-0.73||||0.09|TWO_SIDED|90.0|-1.42|-0.03||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in the expression of Bcl2+ among CD4+ T-cells from Entry to Week 12.||-0.03|-1.42|0.09
72495192|NCT02475655|144519387|SUPERIORITY||Mean Difference (Net)|-5.4|||<|0.001|TWO_SIDED|90.0|-7.29|-3.5||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in the expression of Bcl2+ among CD8+ T-cells from Entry to Week 5.||-3.50|-7.29|<0.001
72495193|NCT02475655|144519387|SUPERIORITY||Mean Difference (Net)|-1.23||||0.11|TWO_SIDED|90.0|-2.51|0.05||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in the expression of Bcl2+ among CD8+ T-cells from Entry to Week 12.||0.05|-2.51|0.11
72495194|NCT02475655|144519388|SUPERIORITY||Mean Difference (Net)|-1.54||||0.26|TWO_SIDED|90.0|-3.78|0.7||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in the expression of a4b7+ among CD4+ T-cells from Entry to Week 5.||0.70|-3.78|0.26
72618830|NCT06097273|144768198|SUPERIORITY|The superiority in seroconversion rate (SCR) in the Cohort A1 group compared with that of Cohort A2 group was demonstrated if the lower bound of the 95% CI of the SCR difference was \>0%.|Percentage Difference|5.4|||||TWO_SIDED|95.0|2.4|8.4||||||Percentage Difference (Cohort A1 vs Cohort A2) for Influenza A H1N1 Antibody||8.4|2.4|
72618831|NCT06097273|144768198|NON_INFERIORITY|The noninferiority in SCR in the Cohort A1 group compared with that of Cohort A2 group was demonstrated if the lower bound of the 97.5% CI of the SCR difference was \>-10%.|Percentage Difference|5.4|||||TWO_SIDED|97.5|1.9|8.8||||||Percentage Difference (Cohort A1 vs Cohort A2) for Influenza A H1N1 Antibody||8.8|1.9|
72618832|NCT06097273|144768198|SUPERIORITY|The superiority in SCR in the Cohort A1 group compared with that of Cohort A2 group was demonstrated if the lower bound of the 95% CI of the SCR difference was \>0%.|Percentage Difference|4.0|||||TWO_SIDED|95.0|1.0|7.1||||||Percentage Difference (Cohort A1 vs Cohort A2) for Influenza A H3N2 Antibody||7.1|1.0|
72437847|NCT04956575|144388608|OTHER||Percent Difference|38.34|||||TWO_SIDED|95.0|22.98|52.3|||||Seroconversion percent difference of mRNA-1010 - Afluria Quadrivalent. 95% CI was calculated using the Miettinen-Nurminen (score) method.|Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against H3N2 at Day 29.||52.30|22.98|
72437848|NCT04956575|144388608|OTHER||Percent Difference|-9.78|||||TWO_SIDED|95.0|-24.83|3.79|||||Seroconversion percent difference of mRNA-1010 - Afluria Quadrivalent. 95% CI was calculated using the Miettinen-Nurminen (score) method.|Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against Victoria-lineage at Day 29.||3.79|-24.83|
72558678|NCT00521586|144647377|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was to be concluded if the lower limit of the 2-sided 95% CI for the GMR was greater than 0.5 (2-fold criterion).|Geometric mean ratio|0.75|||||TWO_SIDED|95.0|0.6|0.93||||||Serotype 6B: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution.||0.93|0.60|
72558679|NCT00521586|144647377|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was to be concluded if the lower limit of the 2-sided 95% CI for the GMR was greater than 0.5 (2-fold criterion).|Geometric mean ratio|0.77|||||TWO_SIDED|95.0|0.63|0.95||||||Serotype 7F: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution.||0.95|0.63|
72495195|NCT02475655|144519388|SUPERIORITY||Mean Difference (Net)|-0.39||||0.74|TWO_SIDED|90.0|-2.41|1.62||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in the expression of a4b7+ among CD4+ T-cells from Entry to Week 12.||1.62|-2.41|0.74
72558680|NCT00521586|144647377|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was to be concluded if the lower limit of the 2-sided 95% CI for the GMR was greater than 0.5 (2-fold criterion).|Geometric mean ratio|0.71|||||TWO_SIDED|95.0|0.59|0.86||||||Serotype 9V: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution||0.86|0.59|
72558681|NCT00521586|144647377|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was to be concluded if the lower limit of the 2-sided 95% CI for the GMR was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|0.77|||||TWO_SIDED|95.0|0.6|0.98||||||Serotype 14: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution||0.98|0.60|
72558682|NCT00521586|144647377|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was to be concluded if the lower limit of the 2-sided 95% CI for the GMR was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|0.72|||||TWO_SIDED|95.0|0.58|0.88||||||Serotype 18C: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution||0.88|0.58|
72618833|NCT06097273|144768198|NON_INFERIORITY|The noninferiority in SCR in the Cohort A1 group compared with that of Cohort A2 group was demonstrated if the lower bound of the 97.5% CI of the SCR difference was \>-10%.|Percentage Difference|4.0|||||TWO_SIDED|97.5|0.5|7.6||||||Percentage Difference (Cohort A1 vs Cohort A2) for Influenza A H3N2 Antibody||7.6|0.5|
72385400|NCT01914757|144278765|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|15.86||||0.029|TWO_SIDED|95.0|1.59|30.12|||Mixed Models Analysis|Model includes treatment, baseline morning PEF, region, use of OCS, visit, and visit by treatment.||Morning PEF Change from Baseline to Week 56||30.12|1.59|0.029
72385401|NCT01914757|144278765|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|15.27||||0.037|TWO_SIDED|95.0|0.9|29.64|||Mixed Models Analysis|Model includes treatment, baseline morning PEF, region, use of OCS, visit, and visit by treatment.||Morning PEF Change from Baseline to Week 56||29.64|0.9|0.037
72385402|NCT01914757|144278765|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|17.54||||0.018|TWO_SIDED|95.0|3.07|32.0|||Mixed Models Analysis|Model includes treatment, baseline evening PEF, region, use of OCS, visit, and visit by treatment.||Evening PEF Change from Baseline to Week 56||32|3.07|0.018
72385403|NCT01914757|144278765|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|21.22||||0.004|TWO_SIDED|95.0|6.65|35.79|||Mixed Models Analysis|Model includes treatment, baseline evening PEF, region, use of OCS, visit, and visit by treatment.||Evening PEF Change from Baseline to Week 56||35.79|6.65|0.004
72385404|NCT01914757|144278766|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02||||0.4|TWO_SIDED|95.0|-0.06|0.03|||Mixed Models Analysis|Model includes treatment, baseline prop of nights with nocturnal wakening, region, use of OCS, visit, and visit by treatment.||||0.03|-0.06|0.4
72385405|NCT01914757|144278766|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.03||||0.146|TWO_SIDED|95.0|-0.08|0.01|||Mixed Models Analysis|Model includes treatment, baseline prop of nights with nocturnal wakening, region, use of OCS, visit, and visit by treatment.||||0.01|-0.08|0.146
72385406|NCT01914757|144278767|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.19||||0.043|TWO_SIDED|95.0|-0.38|-0.01|||Mixed Models Analysis|Model includes treatment, baseline ACQ-6 score, region, use of OCS, visit, and visit by treatment.||||-0.01|-0.38|0.043
72385407|NCT01914757|144278767|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.25||||0.008|TWO_SIDED|95.0|-0.44|-0.07|||Mixed Models Analysis|Model includes treatment, baseline ACQ-6 score, region, use of OCS, visit, and visit by treatment.||||-0.07|-0.44|0.008
72385408|NCT01914757|144278768|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.24||||0.078|TWO_SIDED|95.0|-0.51|0.03|||Mixed Models Analysis|Model includes treatment, baseline ACQ-6 score, region, use of OCS, visit, and visit by treatment.||||0.03|-0.51|0.078
72385409|NCT01914757|144278768|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.449|TWO_SIDED|95.0|-0.37|0.16|||Mixed Models Analysis|Model includes treatment, baseline ACQ-6 score, region, use of OCS, visit, and visit by treatment.||||0.16|-0.37|0.449
72385410|NCT01914757|144278769|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.46|||<|0.001|TWO_SIDED|95.0|0.31|0.69|||Cochran-Mantel-Haenszel|Controlling for region, number of exacerbations in the previous year, use of OCS||Proportion of patients with \>=1 asthma exacerbation||0.69|0.31|<0.001
72385411|NCT01914757|144278769|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.65||||0.023|TWO_SIDED|95.0|0.45|0.95|||Cochran-Mantel-Haenszel|Controlling for region, number of exacerbations in the previous year, use of OCS||Proportion of patients with \>=1 asthma exacerbation||0.95|0.45|0.023
72385412|NCT01914757|144278770|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.61|||<|0.001|TWO_SIDED|95.0|0.46|0.8|||Regression, Cox|Model includes treatment, region, number of exacerbations in the previous year, use of OCS||Time to first Exacerbation||0.80|0.46|<0.001
72385413|NCT01914757|144278770|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.73||||0.018|TWO_SIDED|95.0|0.55|0.95|||Regression, Cox|Model includes treatment, region, number of exacerbations in the previous year, use of OCS||Time to first asthma exacerbation||0.95|0.55|0.018
72437849|NCT04956575|144388608|OTHER||Percent Difference|0.64|||||TWO_SIDED|95.0|-14.91|14.73|||||Seroconversion percent difference of mRNA-1010 - Afluria Quadrivalent. 95% CI was calculated using the Miettinen-Nurminen (score) method.|Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against Victoria-lineage at Day 29.||14.73|-14.91|
72437850|NCT04956575|144388608|OTHER||Percent Difference|4.45|||||TWO_SIDED|95.0|-11.19|18.59|||||Seroconversion percent difference of mRNA-1010 - Afluria Quadrivalent. 95% CI was calculated using the Miettinen-Nurminen (score) method.|Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against Victoria-lineage at Day 29.||18.59|-11.19|
72437851|NCT04956575|144388608|OTHER||Percent Difference|8.97|||||TWO_SIDED|95.0|-6.72|23.09|||||Seroconversion percent difference of mRNA-1010 - Afluria Quadrivalent. 95% CI was calculated using the Miettinen-Nurminen (score) method.|Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against Yamagata-lineage at Day 29.||23.09|-6.72|
72437852|NCT04956575|144388608|OTHER||Percent Difference|15.13|||||TWO_SIDED|95.0|-0.74|29.37|||||Seroconversion percent difference of mRNA-1010 - Afluria Quadrivalent. 95% CI was calculated using the Miettinen-Nurminen (score) method.|Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against Yamagata-lineage at Day 29.||29.37|-0.74|
72437853|NCT04956575|144388608|OTHER||Percent Difference|19.08|||||TWO_SIDED|95.0|3.22|33.22|||||Seroconversion percent difference of mRNA-1010 - Afluria Quadrivalent. 95% CI was calculated using the Miettinen-Nurminen (score) method.|Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent. against Yamagata-lineage at Day 29.||33.22|3.22|
72437854|NCT04956575|144388609|OTHER||Percent Difference|9.18|||||TWO_SIDED|95.0|-10.62|28.31|||||Seroconversion percent difference of mRNA-1010 - Afluria Quadrivalent. 95% CI was calculated using the Miettinen-Nurminen (score) method.|Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against H1N1 at Day 29.||28.31|-10.62|
72437855|NCT04956575|144388609|OTHER||Percent Difference|18.09|||||TWO_SIDED|95.0|-1.81|36.61|||||Seroconversion percent difference of mRNA-1010 - Afluria Quadrivalent. 95% CI was calculated using the Miettinen-Nurminen (score) method.|Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against H1N1 at Day 29.||36.61|-1.81|
72437856|NCT04956575|144388609|OTHER||Percent Difference|23.91|||||TWO_SIDED|95.0|4.2|41.86|||||Seroconversion percent difference of mRNA-1010 - Afluria Quadrivalent. 95% CI was calculated using the Miettinen-Nurminen (score) method.|Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against H1N1 at Day 29.||41.86|4.20|
72437857|NCT04956575|144388609|OTHER||Percent Difference|1.15|||||TWO_SIDED|95.0|-18.41|20.6|||||Seroconversion percent difference of mRNA-1010 - Afluria Quadrivalent. 95% CI was calculated using the Miettinen-Nurminen (score) method.|Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against H3N2 at Day 29.||20.60|-18.41|
72437858|NCT04956575|144388609|OTHER||Percent Difference|22.21|||||TWO_SIDED|95.0|2.09|40.6|||||Seroconversion percent difference of mRNA-1010 - Afluria Quadrivalent. 95% CI was calculated using the Miettinen-Nurminen (score) method.|Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against H3N2 at Day 29.||40.60|2.09|
72437859|NCT04956575|144388609|OTHER||Percent Difference|36.68|||||TWO_SIDED|95.0|17.38|53.36|||||Seroconversion percent difference of mRNA-1010 - Afluria Quadrivalent. 95% CI was calculated using the Miettinen-Nurminen (score) method.|Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against H3N2 at Day 29.||53.36|17.38|
72437860|NCT04956575|144388609|OTHER||Percent Difference|-37.71|||||TWO_SIDED|95.0|-53.36|-20.45|||||Seroconversion percent difference of mRNA-1010 - Afluria Quadrivalent. 95% CI was calculated using the Miettinen-Nurminen (score) method.|Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against Victoria-lineage at Day 29.||-20.45|-53.36|
72495196|NCT02475655|144519389|SUPERIORITY||Mean Difference (Net)|0.55||||0.71|TWO_SIDED|90.0|-1.9|3.0||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in the expression of a4b7+ among CD8+ T-cells from Entry to Week 5.||3.00|-1.90|0.71
72437861|NCT04956575|144388609|OTHER||Treatment Difference|-26.18|||||TWO_SIDED|95.0|-43.66|-6.9|||||Seroconversion percent difference of mRNA-1010 - Afluria Quadrivalent. 95% CI was calculated using the Miettinen-Nurminen (score) method.|Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against Victoria-lineage at Day 29.||-6.90|-43.66|
72437862|NCT04956575|144388609|OTHER||Percent Difference|-19.66|||||TWO_SIDED|95.0|-37.95|0.11|||||Seroconversion percent difference of mRNA-1010 - Afluria Quadrivalent. 95% CI was calculated using the Miettinen-Nurminen (score) method.|Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against Victoria-lineage at Day 29.||0.11|-37.95|
72437863|NCT04956575|144388609|OTHER||Percent Difference|-23.43|||||TWO_SIDED|95.0|-41.09|-4.26|||||Seroconversion percent difference of mRNA-1010 - Afluria Quadrivalent. 95% CI was calculated using the Miettinen-Nurminen (score) method.|Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against Yamagata-lineage at Day 29.||-4.26|-41.09|
72437864|NCT04956575|144388609|OTHER||Percent Difference|-4.44|||||TWO_SIDED|95.0|-24.09|15.59|||||Seroconversion percent difference of mRNA-1010 - Afluria Quadrivalent. 95% CI was calculated using the Miettinen-Nurminen (score) method.|Humoral immunogenicity of mRNA-1010 relative to that of against Afluria Quadrivalent Yamagata-lineage at Day 29.||15.59|-24.09|
72437865|NCT04956575|144388609|OTHER||Percent Difference|-8.79|||||TWO_SIDED|95.0|-28.13|11.27|||||Seroconversion percent difference of mRNA-1010 - Afluria Quadrivalent. 95% CI was calculated using the Miettinen-Nurminen (score) method.|Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against Yamagata-lineage at Day 29.||11.27|-28.13|
72437866|NCT03593876|144388615|OTHER||||||||||||||||||The a priori analysis plan was to defer statistical or hypothesis testing due to the focus on feasibility, and rather to assess mean participant-therapist communication scores across intervention sessions. The mean and standard deviation of these scores was 3.00 (1.00). The a priori criterion for feasibility was a mean score of 2.0 or greater.|||
72437867|NCT03593876|144388616|OTHER||Mean Difference (Net)|51.71|STANDARD_DEVIATION|21.04|||TWO_SIDED|||||||||The a priori analysis plan was to defer statistical or hypothesis testing due to the focus on feasibility, and rather to assess change scores and effect size of the change scores to compare with previously published clinical trials.|The repeated measures effect size of change was Cohen's d(rm)=3.08.|||
72437868|NCT03593876|144388617|OTHER||Mean Difference (Net)|11.02|STANDARD_DEVIATION|7.24|||TWO_SIDED|||||||||The a priori analysis plan was to defer statistical or hypothesis testing due to the focus on feasibility, and rather to assess change scores and effect size of the change scores to compare with previously published clinical trials.|The repeated measures effect size of change, Cohen's d(rm)=1.70|||
72437869|NCT03622580|144388659|NON_INFERIORITY|If the lower bound of the two-sided 97.52% confidence interval for the difference in adjusted means for the faricimab 6 mg Q8W and the active comparator (aflibercept 2 mg Q8W) arms was greater than -4 letters, then faricimab 6 mg Q8W was considered non-inferior to aflibercept 2 mg Q8W. Non-inferiority was tested one-sided at a significance level of α = 0.0248.|Adjusted mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.79|||TWO_SIDED|97.5|-2.0|1.6|||||The difference in adjusted means was calculated as Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W in the ITT Population.|Three hypotheses were tested in order for each faricimab arm (Q8W or PTI) separately against the aflibercept arm using a graph-based testing procedure. The analysis presented here is for the non-inferiority of Arm A: Faricimab 6 mg Q8W compared with Arm C: Aflibercept 2 mg Q8W in the ITT Population.||1.6|-2.0|
72437870|NCT03622580|144388659|NON_INFERIORITY|If the lower bound of the two-sided 97.52% confidence interval for the difference in adjusted means for the faricimab 6 mg PTI and the active comparator (aflibercept 2 mg Q8W) arms was greater than -4 letters, then faricimab 6 mg PTI was considered non-inferior to aflibercept 2 mg Q8W. Non-inferiority was tested one-sided at a significance level of α = 0.0248.|Adjusted mean difference|0.7|STANDARD_ERROR_OF_MEAN|0.79|||TWO_SIDED|97.5|-1.1|2.5|||||The difference in adjusted means was calculated as Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W in the ITT Population.|Three hypotheses were tested in order for each faricimab arm (Q8W or PTI) separately against the aflibercept arm using a graph-based testing procedure. The analysis presented here is for the non-inferiority of Arm B: Faricimab 6 mg PTI compared with Arm C: Aflibercept 2 mg Q8W in the ITT Population.||2.5|-1.1|
72437871|NCT03622580|144388659|SUPERIORITY||Adjusted mean difference|-0.7|STANDARD_ERROR_OF_MEAN|0.95||0.4699|TWO_SIDED|97.5|-2.8|1.4||Tested at an overall significance level of α = 0.0248.|Mixed Model for Repeated Measures||The difference in adjusted means was calculated as Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W in the Treatment-Naive Population.|Three hypotheses were tested in order for each faricimab arm (Q8W or PTI) separately against the aflibercept arm using a graph-based testing procedure. The analysis presented here is for the superiority of Arm A: Faricimab 6 mg Q8W compared with Arm C: Aflibercept 2 mg Q8W in the Treatment-Naive Population.||1.4|-2.8|0.4699
72437872|NCT03622580|144388659|SUPERIORITY||Adjusted mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.94||0.965|TWO_SIDED|97.5|-2.1|2.2||Tested at an overall significance level of α = 0.0248.|Mixed Model for Repeated Measures||The difference in adjusted means was calculated as Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W in the Treatment-Naive Population.|Three hypotheses were tested in order for each faricimab arm (Q8W or PTI) separately against the aflibercept arm using a graph-based testing procedure. The analysis presented here is for the superiority of Arm B: Faricimab 6 mg PTI compared with Arm C: Aflibercept 2 mg Q8W in the Treatment-Naive Population.||2.2|-2.1|0.9650
72437873|NCT03622580|144388659|SUPERIORITY||Adjusted mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.79||0.7967|TWO_SIDED|97.5|-2.0|1.6||Tested at an overall significance level of α = 0.0248.|Mixed Model for Repeated Measures||The difference in adjusted means was calculated as Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W in the ITT Population.|Three hypotheses were tested in order for each faricimab arm (Q8W or PTI) separately against the aflibercept arm using a graph-based testing procedure. The analysis presented here is for the superiority of Arm A: Faricimab 6 mg Q8W compared with Arm C: Aflibercept 2 mg Q8W in the ITT Population.||1.6|-2.0|0.7967
72437874|NCT03622580|144388659|SUPERIORITY||Adjusted mean difference|0.7|STANDARD_ERROR_OF_MEAN|0.79||0.3772|TWO_SIDED|97.5|-1.1|2.5||Tested at an overall significance level of α = 0.0248.|Mixed Model for Repeated Measures||The difference in adjusted means was calculated as Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W in the ITT Population.|Three hypotheses were tested in order for each faricimab arm (Q8W or PTI) separately against the aflibercept arm using a graph-based testing procedure. The analysis presented here is for the superiority of Arm B: Faricimab 6 mg PTI compared with Arm C: Aflibercept 2 mg Q8W in the ITT Population.||2.5|-1.1|0.3772
72437875|NCT03622580|144388660|NON_INFERIORITY|If the lower bound of the two-sided 97.52% confidence interval for the difference in CMH weighted percentages of participants for the faricimab 6 mg Q8W and the active comparator (aflibercept 2 mg Q8W) arms was greater than -10%, then faricimab 6 mg Q8W was considered non-inferior to aflibercept 2 mg Q8W.|Difference in CMH Weighted Percentage|10.2|||||TWO_SIDED|97.5|0.3|20.0||||||The analysis presented here is for the non-inferiority of Arm A: Faricimab 6 mg Q8W compared with Arm C: Aflibercept 2 mg Q8W in the ITT Population.||20.0|0.3|
72437876|NCT03622580|144388660|NON_INFERIORITY|If the lower bound of the two-sided 97.52% confidence interval for the difference in CMH weighted percentages of participants for the faricimab 6 mg PTI and the active comparator (aflibercept 2 mg Q8W) arms was greater than -10%, then faricimab 6 mg PTI was considered non-inferior to aflibercept 2 mg Q8W.|Difference in CMH Weighted Percentage|6.1|||||TWO_SIDED|97.5|-3.6|15.8||||||The analysis presented here is for the non-inferiority of Arm B: Faricimab 6 mg PTI compared with Arm C: Aflibercept 2 mg Q8W in the ITT Population.||15.8|-3.6|
72437877|NCT03622580|144388660|SUPERIORITY||Difference in CMH Weighted Percentage|7.2||||0.1761|TWO_SIDED|97.5|-4.6|18.9||Tested at an overall significance level of α = 0.0248.|Cochran-Mantel-Haenszel|||The analysis presented here is for the superiority of Arm A: Faricimab 6 mg Q8W compared with Arm C: Aflibercept 2 mg Q8W in the Treatment-Naive Population.||18.9|-4.6|0.1761
72437878|NCT03622580|144388660|SUPERIORITY||Difference in CMH Weighted Percentage|4.8||||0.3539|TWO_SIDED|97.5|-6.7|16.3||Tested at an overall significance level of α = 0.0248.|Cochran-Mantel-Haenszel|||The analysis presented here is for the superiority of Arm B: Faricimab 6 mg PTI compared with Arm C: Aflibercept 2 mg Q8W in the Treatment-Naive Population.||16.3|-6.7|0.3539
72495197|NCT02475655|144519389|SUPERIORITY||Mean Difference (Net)|0.31||||0.83|TWO_SIDED|90.0|-2.15|2.78||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in the expression of a4b7+ among CD8+ T-cells from Entry to Week 12.||2.78|-2.15|0.83
72437879|NCT03622580|144388660|SUPERIORITY||Difference in CMH Weighted Percentage|10.2||||0.0237|TWO_SIDED|97.5|0.3|20.0||Tested at an overall significance level of α = 0.0248.|Cochran-Mantel-Haenszel|||The analysis presented here is for the superiority of Arm A: Faricimab 6 mg Q8W compared with Arm C: Aflibercept 2 mg Q8W in the ITT Population.||20.0|0.3|0.0237
72437880|NCT03622580|144388660|SUPERIORITY||Difference in CMH Weighted Percentage|6.1||||0.1677|TWO_SIDED|97.5|-3.6|15.8||Tested at an overall significance level of α = 0.0248.|Cochran-Mantel-Haenszel|||The analysis presented here is for the superiority of Arm B: Faricimab 6 mg PTI compared with Arm C: Aflibercept 2 mg Q8W in the ITT Population.||15.8|-3.6|0.1677
72437881|NCT03622580|144388663|OTHER||Difference in CMH Weighted Percentage|-2.6|||||TWO_SIDED|95.0|-10.0|4.9||||||This is the difference in percentage of participants gaining ≥15 letters in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W.||4.9|-10.0|
72437882|NCT03622580|144388663|OTHER||Difference in CMH Weighted Percentage|3.5|||||TWO_SIDED|95.0|-4.0|11.1||||||This is the difference in percentage of participants gaining ≥15 letters in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W.||11.1|-4.0|
72437883|NCT03622580|144388663|OTHER||Difference in CMH Weighted Percentage|-0.4|||||TWO_SIDED|95.0|-8.6|7.9||||||This is the difference in percentage of participants gaining ≥10 letters in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W.||7.9|-8.6|
72437884|NCT03622580|144388663|OTHER||Difference in CMH Weighted Percentage|0.7|||||TWO_SIDED|95.0|-7.4|8.8||||||This is the difference in percentage of participants gaining ≥10 letters in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W.||8.8|-7.4|
72437885|NCT03622580|144388663|OTHER||Difference in CMH Weighted Percentage|-2.5|||||TWO_SIDED|95.0|-9.1|4.1||||||This is the difference in percentage of participants gaining ≥5 letters in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W.||4.1|-9.1|
72437886|NCT03622580|144388663|OTHER||Difference in CMH Weighted Percentage|-2.0|||||TWO_SIDED|95.0|-8.5|4.5||||||This is the difference in percentage of participants gaining ≥5 letters in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W.||4.5|-8.5|
72437887|NCT03622580|144388663|OTHER||Difference in CMH Weighted Percentage|0.1|||||TWO_SIDED|95.0|-4.6|4.8||||||This is the difference in percentage of participants gaining ≥0 letters in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W.||4.8|-4.6|
72437888|NCT03622580|144388663|OTHER||Difference in CMH Weighted Percentage|3.3|||||TWO_SIDED|95.0|-1.0|7.5||||||This is the difference in percentage of participants gaining ≥0 letters in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W.||7.5|-1.0|
72495198|NCT02475655|144519390|SUPERIORITY||Mean Difference (Net)|-1.33||||0.01|TWO_SIDED|90.0|-2.16|-0.5||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in the expression of CX3CR1+ among CD4+ T-cells from Entry to Week 5.||-0.50|-2.16|0.010
72437889|NCT03622580|144388668|OTHER||Difference in CMH Weighted Percentage|-5.2|||||TWO_SIDED|95.0|-14.0|3.5||||||This is the difference in percentage of participants gaining ≥15 letters in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W.||3.5|-14.0|
72437890|NCT03622580|144388668|OTHER||Difference in CMH Weighted Percentage|1.7|||||TWO_SIDED|95.0|-7.0|10.3||||||This is the difference in percentage of participants gaining ≥15 letters in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W.||10.3|-7.0|
72437891|NCT03622580|144388668|OTHER||Difference in CMH Weighted Percentage|0.0|||||TWO_SIDED|95.0|-9.5|9.5||||||This is the difference in percentage of participants gaining ≥10 letters in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W.||9.5|-9.5|
72437892|NCT03622580|144388668|OTHER||Difference in CMH Weighted Percentage|2.1|||||TWO_SIDED|95.0|-7.1|11.3||||||This is the difference in percentage of participants gaining ≥10 letters in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W.||11.3|-7.1|
72437893|NCT03622580|144388668|OTHER||Difference in CMH Weighted Percentage|-4.5|||||TWO_SIDED|95.0|-11.9|2.9||||||This is the difference in percentage of participants gaining ≥5 letters in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W.||2.9|-11.9|
72437894|NCT03622580|144388668|OTHER||Difference in CMH Weighted Percentage|-7.2|||||TWO_SIDED|95.0|-14.6|0.2||||||This is the difference in percentage of participants gaining ≥5 letters in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W.||0.2|-14.6|
72437895|NCT03622580|144388668|OTHER||Difference in CMH Weighted Percentage|-0.2|||||TWO_SIDED|95.0|-5.5|5.2||||||This is the difference in percentage of participants gaining ≥0 letters in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W.||5.2|-5.5|
72437896|NCT03622580|144388668|OTHER||Difference in CMH Weighted Percentage|2.0|||||TWO_SIDED|95.0|-3.0|7.0||||||This is the difference in percentage of participants gaining ≥0 letters in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W.||7.0|-3.0|
72437897|NCT03622580|144388673|OTHER||Difference in CMH Weighted Percentage|-0.8|||||TWO_SIDED|95.0|-2.8|1.3||||||This is the difference in percentage of participants avoiding a loss of ≥15 letters in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W.||1.3|-2.8|
72437898|NCT03622580|144388673|OTHER||Difference in CMH Weighted Percentage|-0.3|||||TWO_SIDED|95.0|-2.2|1.5||||||This is the difference in percentage of participants avoiding a loss of ≥15 letters in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W.||1.5|-2.2|
72437899|NCT03622580|144388673|OTHER||Difference in CMH Weighted Percentage|-1.8|||||TWO_SIDED|95.0|-4.6|0.9||||||This is the difference in percentage of participants avoiding a loss of ≥10 letters in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W.||0.9|-4.6|
72437900|NCT03622580|144388673|OTHER||Difference in CMH Weighted Percentage|0.0|||||TWO_SIDED|95.0|-2.2|2.2||||||This is the difference in percentage of participants avoiding a loss of ≥10 letters in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W.||2.2|-2.2|
72437901|NCT03622580|144388673|OTHER||Difference in CMH Weighted Percentage|-1.1|||||TWO_SIDED|95.0|-4.5|2.2||||||This is the difference in percentage of participants avoiding a loss of ≥5 letters in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W.||2.2|-4.5|
72437902|NCT03622580|144388673|OTHER||Difference in CMH Weighted Percentage|0.4|||||TWO_SIDED|95.0|-2.6|3.4||||||This is the difference in percentage of participants avoiding a loss of ≥5 letters in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W.||3.4|-2.6|
72437903|NCT03622580|144388677|OTHER||Difference in CMH Weighted Percentage|-1.1|||||TWO_SIDED|95.0|-3.5|1.3||||||This is the difference in percentage of participants avoiding a loss of ≥15 letters in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W.||1.3|-3.5|
72437904|NCT03622580|144388677|OTHER||Difference in CMH Weighted Percentage|-0.9|||||TWO_SIDED|95.0|-3.1|1.3||||||This is the difference in percentage of participants avoiding a loss of ≥15 letters in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W.||1.3|-3.1|
72437905|NCT03622580|144388677|OTHER||Difference in CMH Weighted Percentage|-2.1|||||TWO_SIDED|95.0|-5.1|0.9||||||This is the difference in percentage of participants avoiding a loss of ≥10 letters in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W.||0.9|-5.1|
72437906|NCT03622580|144388677|OTHER||Difference in CMH Weighted Percentage|-0.9|||||TWO_SIDED|95.0|-3.5|1.6||||||This is the difference in percentage of participants avoiding a loss of ≥10 letters in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W.||1.6|-3.5|
72558683|NCT00521586|144647377|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was to be concluded if the lower limit of the 2-sided 95% CI for the GMR was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|0.89|||||TWO_SIDED|95.0|0.74|1.08||||||Serotype 19A: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution||1.08|0.74|
72558684|NCT00521586|144647377|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was to be concluded if the lower limit of the 2-sided 95% CI for the GMR was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|0.86|||||TWO_SIDED|95.0|0.67|1.1||||||Serotype 19F: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution||1.10|0.67|
72437907|NCT03622580|144388677|OTHER||Difference in CMH Weighted Percentage|-1.2|||||TWO_SIDED|95.0|-5.2|2.8||||||This is the difference in percentage of participants avoiding a loss of ≥5 letters in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W.||2.8|-5.2|
72437908|NCT03622580|144388677|OTHER||Difference in CMH Weighted Percentage|-0.4|||||TWO_SIDED|95.0|-4.1|3.3||||||This is the difference in percentage of participants avoiding a loss of ≥5 letters in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W.||3.3|-4.1|
72437909|NCT03622580|144388681|OTHER||Difference in CMH Weighted Percentage|-4.9|||||TWO_SIDED|95.0|-12.6|2.9||||||This is the difference in percentage of participants in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W for the ITT Population.||2.9|-12.6|
72437910|NCT03622580|144388681|OTHER||Difference in CMH Weighted Percentage|2.0|||||TWO_SIDED|95.0|-5.9|9.8||||||This is the difference in percentage of participants in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W for the ITT Population.||9.8|-5.9|
72437911|NCT03622580|144388681|OTHER||Difference in CMH Weighted Percentage|-8.6|||||TWO_SIDED|95.0|-17.8|0.5||||||This is the difference in percentage of participants in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W for the Treatment-Naive Population.||0.5|-17.8|
72495199|NCT02475655|144519390|SUPERIORITY||Mean Difference (Net)|-0.17||||0.74|TWO_SIDED|90.0|-1.02|0.68||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in the expression of CX3CR1+ among CD4+ T-cells from Entry to Week 12.||0.68|-1.02|0.74
72558685|NCT00521586|144647377|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was to be concluded if the lower limit of the 2-sided 95% CI for the GMR was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|0.84|||||TWO_SIDED|95.0|0.66|1.08||||||Serotype 23F: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution||1.08|0.66|
72437912|NCT03622580|144388681|OTHER||Difference in CMH Weighted Percentage|-0.9|||||TWO_SIDED|95.0|-9.9|8.2||||||This is the difference in percentage of participants in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W for the Treatment-Naive Population.||8.2|-9.9|
72437913|NCT03622580|144388684|OTHER||Difference in CMH Weighted Percentage|-3.2|||||TWO_SIDED|95.0|-10.2|3.8||||||This is the difference in percentage of participants in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W for the ITT Population.||3.8|-10.2|
72437914|NCT03622580|144388684|OTHER||Difference in CMH Weighted Percentage|2.4|||||TWO_SIDED|95.0|-4.3|9.2||||||This is the difference in percentage of participants in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W for the ITT Population.||9.2|-4.3|
72437915|NCT03622580|144388684|OTHER||Difference in CMH Weighted Percentage|-4.7|||||TWO_SIDED|95.0|-12.6|3.1||||||This is the difference in percentage of participants in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W for the Treatment-Naive Population.||3.1|-12.6|
72437916|NCT03622580|144388684|OTHER||Difference in CMH Weighted Percentage|-1.3|||||TWO_SIDED|95.0|-8.9|6.4||||||This is the difference in percentage of participants in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W for the Treatment-Naive Population.||6.4|-8.9|
72437917|NCT03622580|144388687|OTHER||Difference in CMH Weighted Percentage|0.6|||||TWO_SIDED|95.0|-1.8|2.9||||||This is the difference in percentage of participants in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W for the ITT Population.||2.9|-1.8|
72437918|NCT03622580|144388687|OTHER||Difference in CMH Weighted Percentage|0.0|||||TWO_SIDED|95.0|-2.2|2.3||||||This is the difference in percentage of participants in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W for the ITT Population.||2.3|-2.2|
72437919|NCT03622580|144388687|OTHER||Difference in CMH Weighted Percentage|0.8|||||TWO_SIDED|95.0|-2.0|3.6||||||This is the difference in percentage of participants in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W for the Treatment-Naive Population.||3.6|-2.0|
72437920|NCT03622580|144388687|OTHER||Difference in CMH Weighted Percentage|0.0|||||TWO_SIDED|95.0|-2.6|2.5||||||This is the difference in percentage of participants in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W for the Treatment-Naive Population.||2.5|-2.6|
72437921|NCT03622580|144388696|OTHER||Difference in CMH Weighted Percentage|0.4|||||TWO_SIDED|95.0|-1.1|2.0||||||This is the difference in percentage of participants in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W for the ITT Population.||2.0|-1.1|
72437922|NCT03622580|144388696|OTHER||Difference in CMH Weighted Percentage|0.4|||||TWO_SIDED|95.0|-1.1|2.0||||||This is the difference in percentage of participants in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W for the ITT Population.||2.0|-1.1|
72437923|NCT03622580|144388696|OTHER||Difference in CMH Weighted Percentage|-0.6|||||TWO_SIDED|95.0|-1.9|0.6||||||This is the difference in percentage of participants in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W for the Treatment-Naive Population.||0.6|-1.9|
72437924|NCT03622580|144388696|OTHER||Difference in CMH Weighted Percentage|0.5|||||TWO_SIDED|95.0|-1.5|2.5||||||This is the difference in percentage of participants in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W for the Treatment-Naive Population.||2.5|-1.5|
72437925|NCT03622580|144388697|OTHER||Difference in CMH Weighted Percentage|0.4|||||TWO_SIDED|95.0|-0.4|1.2||||||This is the difference in percentage of participants in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W for the ITT Population.||1.2|-0.4|
72437926|NCT03622580|144388697|OTHER||Difference in CMH Weighted Percentage|0.0|||||TWO_SIDED|95.0|0.0|0.0||||||This is the difference in percentage of participants in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W for the ITT Population.||0.0|0.0|
72437927|NCT03622580|144388697|OTHER||Difference in CMH Weighted Percentage|0.0|||||TWO_SIDED|95.0|0.0|0.0||||||This is the difference in percentage of participants in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W for the Treatment-Naive Population.||0.0|0.0|
72437928|NCT03622580|144388697|OTHER||Difference in CMH Weighted Percentage|0.0|||||TWO_SIDED|95.0|0.0|0.0||||||This is the difference in percentage of participants in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W for the Treatment-Naive Population.||0.0|0.0|
72437929|NCT03622580|144388704|OTHER||Adjusted mean difference|-36.2|STANDARD_ERROR_OF_MEAN|5.88|||TWO_SIDED|95.0|-47.8|-24.7||||||This is the adjusted mean difference for Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W in the ITT Population.||-24.7|-47.8|
72437930|NCT03622580|144388704|OTHER||Adjusted mean difference|-26.2|STANDARD_ERROR_OF_MEAN|5.86|||TWO_SIDED|95.0|-37.7|-14.7||||||This is the adjusted mean difference for Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W in the ITT Population.||-14.7|-37.7|
72437931|NCT03622580|144388704|OTHER||Adjusted mean difference|-31.1|STANDARD_ERROR_OF_MEAN|6.35|||TWO_SIDED|95.0|-43.6|-18.6||||||This is the adjusted mean difference for Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W in the Treatment-Naive Population.||-18.6|-43.6|
72437932|NCT03622580|144388704|OTHER||Adjusted mean difference|-23.9|STANDARD_ERROR_OF_MEAN|6.28|||TWO_SIDED|95.0|-36.2|-11.6||||||This is the adjusted mean difference for Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W in the Treatment-Naive Population.||-11.6|-36.2|
72437933|NCT03622580|144388707|OTHER||Difference in CMH Weighted Percentage|16.0|||||TWO_SIDED|95.0|8.9|23.1||||||This is the difference in percentage of participants in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W for the ITT Population.||23.1|8.9|
72437934|NCT03622580|144388707|OTHER||Difference in CMH Weighted Percentage|12.7|||||TWO_SIDED|95.0|5.4|20.0||||||This is the difference in percentage of participants in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W for the ITT Population.||20.0|5.4|
72437935|NCT03622580|144388707|OTHER||Difference in CMH Weighted Percentage|15.2|||||TWO_SIDED|95.0|7.3|23.2||||||This is the difference in percentage of participants in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W for the Treatment-Naive Population.||23.2|7.3|
72437936|NCT03622580|144388707|OTHER||Difference in CMH Weighted Percentage|12.5|||||TWO_SIDED|95.0|4.4|20.6||||||This is the difference in percentage of participants in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W for the Treatment-Naive Population.||20.6|4.4|
72437937|NCT01930045|144388743|SUPERIORITY_OR_OTHER||Geometric Mean Ratio (GMR)|0.4||||0.507|TWO_SIDED|90.0|0.31|0.52|||Hochberg step-up procedure||The Maalox followed by Raltegravir treatment group was the numerator, and the Raltegravir alone treatment group was the denominator|The hypothesis is that the true Raltegravir C 12 hrs geometric mean ratio (GMR) is not less than 0.4||0.52|0.31|0.507
72437938|NCT01930045|144388743|SUPERIORITY_OR_OTHER||GMR|0.38||||0.624|TWO_SIDED|90.0|0.3|0.49|||Hochberg step-up procedure||The Raltegravir followed by Maalox treatment group was the numerator, and the Raltegravir alone treatment group was the denominator|The hypothesis is that the true Raltegravir C 12 hrs GMR is not less than 0.4||0.49|0.30|0.624
72437939|NCT01930045|144388744|SUPERIORITY_OR_OTHER||GMR|0.81|||||TWO_SIDED|90.0|0.63|1.05|||||The Maalox followed by Raltegravir treatment group was the numerator, and the Raltegravir alone treatment group was the denominator|||1.05|0.63|
72437940|NCT01930045|144388744|SUPERIORITY_OR_OTHER||GMR|0.68|||||TWO_SIDED|90.0|0.5|0.92|||||The Raltegravir followed by Maalox treatment group was the numerator, and the Raltegravir alone treatment group was the denominator|||0.92|0.50|
72437941|NCT01930045|144388745|SUPERIORITY_OR_OTHER||GMR|0.78|||||TWO_SIDED|90.0|0.55|1.1|||||The Maalox followed by Raltegravir treatment group was the numerator, and the Raltegravir alone treatment group was the denominator|||1.10|0.55|
72437942|NCT01930045|144388745|SUPERIORITY_OR_OTHER||GMR|0.7|||||TWO_SIDED|90.0|0.48|1.04|||||The Raltegravir followed by Maalox treatment group was the numerator, and the Raltegravir alone treatment group was the denominator|||1.04|0.48|
72437943|NCT01930045|144388746|SUPERIORITY_OR_OTHER||GMR|0.5|||||TWO_SIDED|90.0|0.39|0.65|||||The Maalox followed by Raltegravir treatment group was the numerator, and the Raltegravir alone treatment group was the denominator|The hypothesis is that the true Raltegravir C 12 hrs GMR is not less than 0.4||0.65|0.39|
72437944|NCT01930045|144388746|SUPERIORITY_OR_OTHER||GMR|0.51|||||TWO_SIDED|90.0|0.4|0.64|||||The Raltegravir followed by Maalox treatment group was the numerator, and the Raltegravir alone treatment group was the denominator|The hypothesis is that the true Raltegravir C 12 hrs GMR is not less than 0.4||0.64|0.40|
72437945|NCT01930045|144388747|SUPERIORITY_OR_OTHER||GMR|0.87|||||TWO_SIDED|90.0|0.64|1.18|||||The Maalox followed by Raltegravir treatment group was the numerator, and the Raltegravir alone treatment group was the denominator|||1.18|0.64|
72437946|NCT01930045|144388747|SUPERIORITY_OR_OTHER||GMR|0.89|||||TWO_SIDED|90.0|0.64|1.22|||||The Raltegravir followed by Maalox treatment group was the numerator, and the Raltegravir alone treatment group was the denominator|||1.22|0.64|
72437947|NCT01930045|144388748|SUPERIORITY_OR_OTHER||GMR|0.9|||||TWO_SIDED|90.0|0.58|1.4|||||The Maalox followed by Raltegravir treatment group was the numerator, and the Raltegravir alone treatment group was the denominator|||1.40|0.58|
72437948|NCT01930045|144388748|SUPERIORITY_OR_OTHER||GMR|0.9|||||TWO_SIDED|90.0|0.58|1.41|||||The Raltegravir followed by Maalox treatment group was the numerator, and the Raltegravir alone treatment group was the denominator|||1.41|0.58|
72437949|NCT03034915|144388762|OTHER||Mean Difference (Net)|0.066|STANDARD_ERROR_OF_MEAN|0.0118|<|0.001|TWO_SIDED|95.0|0.043|0.089|||Mixed model repeated measures||LS Mean difference comparing UMEC/VI versus UMEC at Week 24.|||0.089|0.043|<0.001
72437950|NCT03034915|144388762|OTHER||Mean Difference (Net)|0.141|STANDARD_ERROR_OF_MEAN|0.0117|<|0.001|TWO_SIDED|95.0|0.118|0.164|||Mixed model repeated measures||LS Mean difference comparing UMEC/VI versus salmeterol at Week 24.|||0.164|0.118|<0.001
72385414|NCT01914757|144278771|SUPERIORITY_OR_OTHER||Rate Ratio|0.93||||0.837|TWO_SIDED|95.0|0.48|1.82|||negative binomial|Model includes treatment, region, any prior exacerbation resulting ER/Hospitalization, use of OCS||||1.82|0.48|0.837
72385415|NCT01914757|144278771|SUPERIORITY_OR_OTHER||Rate Ratio|1.23||||0.538|TWO_SIDED|95.0|0.64|2.35|||negative binomial|Model includes treatment, region, any prior exacerbation resulting ER/Hospitalization, use of OCS||||2.35|0.64|0.538
72437951|NCT03034915|144388762|OTHER||Mean Difference (Net)|0.075|STANDARD_ERROR_OF_MEAN|0.0119|<|0.001|TWO_SIDED|95.0|0.051|0.098|||Mixed model repeated measures||LS Mean difference comparing UMEC versus salmeterol at Week 24.|||0.098|0.051|<0.001
72437952|NCT03034915|144388763|OTHER||Mean Difference (Net)|0.37|STANDARD_ERROR_OF_MEAN|0.157||0.018|TWO_SIDED|95.0|0.06|0.68|||Mixed model repeated measures||LS Mean difference comparing UMEC/VI versus UMEC at Week 24.|||0.68|0.06|0.018
72558686|NCT00521586|144647378|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.1|||||TWO_SIDED|95.0|0.83|1.34||||||Serotype 1: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution.||1.34|0.83|
72437953|NCT03034915|144388763|OTHER||Mean Difference (Net)|0.45|STANDARD_ERROR_OF_MEAN|0.155||0.004|TWO_SIDED|95.0|0.15|0.76|||Mixed model repeated measures||LS Mean difference comparing UMEC/VI versus salmeterol at Week 24.|||0.76|0.15|0.004
72437954|NCT03034915|144388763|OTHER||Mean Difference (Net)|0.08|STANDARD_ERROR_OF_MEAN|0.159||0.61|TWO_SIDED|95.0|-0.23|0.39|||Mixed model repeated measures||LS Mean difference comparing UMEC versus salmeterol at Week 24|||0.39|-0.23|0.610
72437955|NCT03034915|144388764|OTHER||Odds Ratio (OR)|1.43|||<|0.001|TWO_SIDED|95.0|1.17|1.75|||generalized linear mixed model||Odds Ratio (responder vs. a non-responder) comparing UMEC/VI vs UMEC at Week 24|||1.75|1.17|<0.001
72437956|NCT03034915|144388764|OTHER||Odds Ratio (OR)|1.48|||<|0.001|TWO_SIDED|95.0|1.21|1.81|||generalized linear mixed model||Odds Ratio (responder vs. a non-responder) comparing UMEC/VI versus salmeterol at Week 24|||1.81|1.21|<0.001
72437957|NCT03034915|144388764|OTHER||Odds Ratio (OR)|1.03||||0.755|TWO_SIDED|95.0|0.84|1.27|||generalized linear mixed model||Odds Ratio (responder vs. a non-responder) comparing UMEC versus salmeterol at Week 24.|||1.27|0.84|0.755
72437958|NCT03034915|144388765|OTHER||Mean Difference (Net)|-0.53|STANDARD_ERROR_OF_MEAN|0.213||0.013|TWO_SIDED|95.0|-0.95|-0.11|||Mixed model repeated measures||LS Mean difference comparing UMEC/VI versus UMEC at Week 21 to Week 24|||-0.11|-0.95|0.013
72437959|NCT03034915|144388765|OTHER||Mean Difference (Net)|-0.83|STANDARD_ERROR_OF_MEAN|0.211|<|0.001|TWO_SIDED|95.0|-1.25|-0.42|||Mixed model repeated measures||LS Mean difference comparing UMEC/VI versus salmeterol at Week 21 to Week 24..|||-0.42|-1.25|<0.001
72385416|NCT01914757|144278775|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.16||||0.119|TWO_SIDED|95.0|-0.04|0.37|||Mixed Models Analysis|Model includes treatment, baseline AQLQ score, region, use of OCS, visit, visit by treatment.||||0.37|-0.04|0.119
72385417|NCT01914757|144278775|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.24||||0.019|TWO_SIDED|95.0|0.04|0.45|||Mixed Models Analysis|Model includes treatment, baseline AQLQ score, region, use of OCS, visit, visit by treatment.||||0.45|0.04|0.019
72385418|NCT00333177|144278797|SUPERIORITY||||||<|0.03||||||P value is for CT-HBT X RLAI-Oral Ris interaction|ANCOVA|Covaried baseline value of dependent variable||A priori hypothesis was that CT would be superior to HBT and that RLAI would enhance this effect.||||<0.03
72437960|NCT03034915|144388765|OTHER||Mean Difference (Net)|-0.3|STANDARD_ERROR_OF_MEAN|0.214||0.159|TWO_SIDED|95.0|-0.72|0.12|||Mixed model repeated measures||LS Mean difference comparing UMEC versus salmeterol at Week 21 to Week 24|||0.12|-0.72|0.159
72437961|NCT03034915|144388766|OTHER||Mean Difference (Net)|-0.27|STANDARD_ERROR_OF_MEAN|0.114||0.016|TWO_SIDED|95.0|-0.5|-0.05||E-RS Breathlessness Score|Mixed model repeated measures||LS Mean difference comparing UMEC/VI versus UMEC at Week 21 to Week 24.|||-0.05|-0.50|0.016
72437962|NCT03034915|144388766|OTHER||Mean Difference (Net)|-0.46|STANDARD_ERROR_OF_MEAN|0.113|<|0.001|TWO_SIDED|95.0|-0.68|-0.23||E-RS Breathlessness Score|Mixed model repeated measures||LS Mean difference comparing UMEC/VI versus salmeterol at Week 21 to Week 24.|||-0.23|-0.68|<0.001
72437963|NCT03034915|144388766|OTHER||Mean Difference (Net)|-0.18|STANDARD_ERROR_OF_MEAN|0.115||0.115|TWO_SIDED|95.0|-0.41|0.04||E-RS Breathlessness Score|Mixed model repeated measures||LS Mean difference comparing UMEC versus salmeterol at Week 21 to Week 24.|||0.04|-0.41|0.115
72437964|NCT03034915|144388766|OTHER||Mean Difference (Net)|-0.07|STANDARD_ERROR_OF_MEAN|0.063||0.247|TWO_SIDED|95.0|-0.2|0.05||E-RS Cough and Sputum Score|Mixed model repeated measures||LS Mean difference comparing UMEC/VI versus UMEC at Week 21 to Week 24.|||0.05|-0.20|0.247
72437965|NCT03034915|144388766|OTHER||Mean Difference (Net)|-0.13|STANDARD_ERROR_OF_MEAN|0.063||0.042|TWO_SIDED|95.0|-0.25|0.0||E-RS Cough and Sputum Score|Mixed model repeated measures||LS Mean difference comparing UMEC/VI versus salmeterol at Week 21 to Week 24.|||0.00|-0.25|0.042
72437966|NCT03034915|144388766|OTHER||Mean Difference (Net)|-0.05|STANDARD_ERROR_OF_MEAN|0.063||0.391|TWO_SIDED|95.0|-0.18|0.07||E-RS Cough and Sputum Score|Mixed model repeated measures||LS Mean difference comparing UMEC versus salmeterol at Week 21 to Week 24.|||0.07|-0.18|0.391
72385419|NCT00333177|144278798|SUPERIORITY||||||<|0.02||||||P-value is for each main effect. A priori threshold for statistical significance was p\<0.05 for each main effect.|ANCOVA|Baseline value of dependent variable was covaried.||2 X 2 ANOVA was calculated. A priori hypotheses were that LAI would be superior to oral risperidone and that CT would be superior to health behavior training (HBT) based on main effects.||||<.02
72385420|NCT00333177|144278799|SUPERIORITY||Mean Difference (Final Values)|0.84||||0.001|TWO_SIDED|95.0|0.57|1.1|||t-test, 2 sided|||A priori hypothesis was that RLAI would lead to less medication non-adherence than Oral Ris.||1.10|.57|.001
72437967|NCT03034915|144388766|OTHER||Mean Difference (Net)|-0.17|STANDARD_ERROR_OF_MEAN|0.07||0.014|TWO_SIDED|95.0|-0.31|-0.04||E-RS Chest Symptoms Score|Mixed model repeated measures||LS Mean difference comparing UMEC/VI versus UMEC at Week 21 to Week 24|||-0.04|-0.31|0.014
72437968|NCT03034915|144388766|OTHER||Mean Difference (Net)|-0.24|STANDARD_ERROR_OF_MEAN|0.069|<|0.001|TWO_SIDED|95.0|-0.37|-0.1||E-RS Chest Symptoms Score|Mixed model repeated measures||LS Mean difference comapring UMEC/VI versus salmeterol at Week 21 to Week 24.|||-0.10|-0.37|<0.001
72437969|NCT03034915|144388766|OTHER||Mean Difference (Net)|-0.07|STANDARD_ERROR_OF_MEAN|0.07||0.34|TWO_SIDED|95.0|-0.2|0.07||E-RS Chest Symptoms Score|Mixed model repeated measures||LS Mean difference comparing UMEC versus salmeterol at Week 21 to Week 24.|||0.07|-0.20|0.340
72437970|NCT03034915|144388767|OTHER||Odds Ratio (OR)|1.52|||<|0.001|TWO_SIDED|95.0|1.22|1.89|||generalized linear mixed model||Odds Ratio (responder vs. a non-responder) comparing UMEC/VI vs UMEC at Week 21 to Week 24|||1.89|1.22|<0.001
72385421|NCT00333177|144278800|SUPERIORITY||||||<|0.05||||||P-value is for CT vs. HBT main effect.|ANCOVA|Baseline value of dependent variable was covaried.||2 X 2 ANOVA was calculated. A priori hypotheses were that CT would be superior to HBT and that RLAI would be superior to Oral Ris.||||<.05
72385422|NCT00333177|144278801|SUPERIORITY|||||||0.55|||||||ANOVA|||||||0.55
72385423|NCT00333177|144278802|SUPERIORITY||||||<|0.02||||||A priori hypotheses were that CT would be superior to HBT and that RLAI would be superior to Oral Ris.|ANOVA|2 X 2 ANOVA was computed.||||||<0.02
72385424|NCT00333177|144278803|SUPERIORITY||||||<|0.01|||||||Chi-squared|df = 1||Chi-square of frequencies of relapse vs. non-relapse were calculated, with a priori hypothesis that RLAI would be superior to Oral Ris.||||<0.01
72385425|NCT00333177|144278804|SUPERIORITY||||||<|0.05||||||2 X 2 ANOVA calculated. P-value is for main effect of RLAI vs. Oral Ris.|ANOVA|||||||<.05
72385426|NCT00333177|144278805|SUPERIORITY||||||<|0.02||||||2 X 2 ANOVA computed. P-value is for main effect of CT vs. HBT.|ANOVA|||||||<.02
72385427|NCT00333177|144278806|SUPERIORITY||||||=|0.053||||||2 X 2 ANOVA computed. P-value is for RLAI vs. Oral Ris main effect.|ANOVA|||||||=.053
72385428|NCT02833350|144278808|SUPERIORITY||Weighted difference|8.0||||0.2503|TWO_SIDED|95.0|-5.64|21.64|||Cochran-Mantel-Haenszel|||||21.64|-5.64|0.2503
72385429|NCT02833350|144278808|SUPERIORITY||Weighted difference|12.93||||0.0164|TWO_SIDED|95.0|2.37|23.48|||Cochran-Mantel-Haenszel|||||23.48|2.37|0.0164
72385430|NCT02833350|144278808|SUPERIORITY||Weighted difference|20.0||||0.0003|TWO_SIDED|95.0|9.21|30.79|||Cochran-Mantel-Haenszel|||||30.79|9.21|0.0003
72385431|NCT02833350|144278810|SUPERIORITY||Weighted difference|-8.58||||0.1694|TWO_SIDED|95.0|-20.82|3.66|||Cochran-Mantel-Haenszel|||||3.66|-20.82|0.1694
72385432|NCT02833350|144278810|SUPERIORITY||Weighted difference|-1.5||||0.8132||95.0|-13.96|10.95|||Cochran-Mantel-Haenszel|||||10.95|-13.96|0.8132
72385433|NCT02833350|144278811|SUPERIORITY||Weighted difference|13.7||||0.0717|TWO_SIDED|95.0|-1.21|28.61|||Cochran-Mantel-Haenszel|||||28.61|-1.21|0.0717
72385434|NCT02833350|144278815|SUPERIORITY||adjusted difference|-0.11||||0.8504|TWO_SIDED|95.0|-0.45|0.23|||ANCOVA|||Week 1, Day 7||0.23|-0.45|0.8504
72385435|NCT02833350|144278815|SUPERIORITY||Adjusted Difference|-0.04||||0.9884|TWO_SIDED|95.0|-0.28|0.21|||ANCOVA|||At week 1, Day 7||0.21|-0.28|0.9884
72385436|NCT02833350|144278815|SUPERIORITY||Adjusted Difference|-0.06||||0.923|TWO_SIDED|95.0|-0.31|0.18|||ANCOVA|||Week 1 Day 7||0.18|-0.31|0.9230
72385437|NCT02833350|144278815|SUPERIORITY||Adjusted Difference|-0.06||||0.9853|TWO_SIDED|95.0|-0.43|0.31|||ANCOVA|||Week 2, Day 14||0.31|-0.43|0.9853
72385438|NCT02833350|144278815|SUPERIORITY||Adjusted Difference|-0.12||||0.6826|TWO_SIDED|95.0|-0.38|0.15|||ANCOVA|||Week 2, Day 14||0.15|-0.38|0.6826
72385439|NCT02833350|144278815|SUPERIORITY||Adjusted Difference|-0.18||||0.2634|TWO_SIDED|95.0|-0.45|0.08|||ANCOVA|||Week 2, Day 14||0.08|-0.45|0.2634
72385440|NCT02833350|144278815|SUPERIORITY||Adjusted Difference|-0.29||||0.2885|TWO_SIDED|95.0|-0.72|0.14|||ANCOVA|||Week 4, Day 28||0.14|-0.72|0.2885
72385441|NCT02833350|144278815|SUPERIORITY||Adjusted Difference|-0.3||||0.0598|TWO_SIDED|95.0|-0.61|0.01|||ANCOVA|||Week 4, Day 28||0.01|-0.61|0.0598
72385442|NCT02833350|144278815|SUPERIORITY||Adjusted Difference|-0.31||||0.044|TWO_SIDED|95.0|-0.62|-0.01|||ANCOVA|||Week 4, Day 28||-0.01|-0.62|0.0440
72385443|NCT02833350|144278815|SUPERIORITY||Adjusted Difference|-0.28||||0.4271|TWO_SIDED|95.0|-0.76|0.2|||ANCOVA|||Week 8, Day 56||0.20|-0.76|0.4271
72385444|NCT02833350|144278815|SUPERIORITY||Adjusted Difference|-0.31||||0.0969|TWO_SIDED|95.0|-0.66|0.04|||ANCOVA|||Week 8, Day 56||0.04|-0.66|0.0969
72385445|NCT02833350|144278815|SUPERIORITY||Adjusted Difference|-0.33||||0.0612|TWO_SIDED|95.0|-0.68|0.01|||ANCOVA|||Week 8, Day 56||0.01|-0.68|0.0612
72437971|NCT03034915|144388767|OTHER||Odds Ratio (OR)|1.53|||<|0.001|TWO_SIDED|95.0|1.23|1.9|||generalized linear mixed model||Odds Ratio (responder vs. a non-responder) comparing UMEC/VI versus salmeterol at Week 21 to Week 24.|||1.90|1.23|<0.001
72385446|NCT02833350|144278815|SUPERIORITY||Adjusted Difference|-0.36||||0.2079|TWO_SIDED|95.0|-0.84|0.12|||ANCOVA|||Week 12, Day 84||0.12|-0.84|0.2079
72385447|NCT02833350|144278815|SUPERIORITY||Adjusted Difference|-0.57||||0.0003|TWO_SIDED|95.0|-0.92|-0.22|||ANCOVA|||Week 12, Day 84||-0.22|-0.92|0.0003
72385448|NCT02833350|144278815|SUPERIORITY||Adjusted Difference|-0.57||||0.0003|TWO_SIDED|95.0|-0.92|-0.22|||ANCOVA|||Week 12, Day 84||-0.22|-0.92|0.0003
72385449|NCT02833350|144278815|SUPERIORITY||Adjusted Difference|0.58|||<|0.0001|TWO_SIDED|95.0|0.34|0.82|||ANCOVA|||Week 1, Day 7||0.82|0.34|<.0001
72385450|NCT02833350|144278815|SUPERIORITY||Mean Difference (Net)|0.55|||<|0.0001|TWO_SIDED|95.0|0.31|0.8|||ANCOVA|||Week 1, Day 7||0.80|0.31|<0.0001
72385451|NCT02833350|144278815|SUPERIORITY||Adjusted Difference|0.47|||<|0.0001|TWO_SIDED|95.0|0.2|0.74|||ANCOVA|||Week 2, Day 14||0.74|0.20|<.0001
72385452|NCT02833350|144278815|SUPERIORITY||Adjusted Difference|0.4||||0.0009|TWO_SIDED|95.0|0.13|0.66|||ANCOVA|||Week 2, Day 14||0.66|0.13|0.0009
72385453|NCT02833350|144278815|SUPERIORITY||Adjusted Difference|0.56|||<|0.0001|TWO_SIDED|95.0|0.25|0.87|||ANCOVA|||Week 4, Day 28||0.87|0.25|<.0001
72385454|NCT02833350|144278815|SUPERIORITY||Adjusted Difference|0.55|||<|0.0001|TWO_SIDED|95.0|0.24|0.85|||ANCOVA|||Week 4, Day 28||0.85|0.24|<.0001
72385455|NCT02833350|144278815|SUPERIORITY||Adjusted Difference|0.42||||0.0095|TWO_SIDED|95.0|0.08|0.76|||ANCOVA|||Week 8, Day 56||0.76|0.08|0.0095
72385456|NCT02833350|144278815|SUPERIORITY||Adjusted Difference|0.4||||0.0153|TWO_SIDED|95.0|0.06|0.74|||ANCOVA|||Week 8, Day 56||0.74|0.06|0.0153
72385457|NCT02833350|144278815|SUPERIORITY||Adjusted Difference|0.19||||0.4839|TWO_SIDED|95.0|-0.16|0.54|||ANCOVA|||Week 12, Day 84||0.54|-0.16|0.4839
72385458|NCT02833350|144278815|SUPERIORITY||Adjusted Difference|0.19||||0.5035|TWO_SIDED|95.0|-0.16|0.53|||ANCOVA|||Week 12, Day 84||0.53|-0.16|0.5035
72385459|NCT02833350|144278815|SUPERIORITY||Adjusted Difference|-0.11||||0.4286|TWO_SIDED|95.0|-0.38|0.16|||ANCOVA|||Week 1, Day 7||0.16|-0.38|0.4286
72385460|NCT02833350|144278815|SUPERIORITY||Adjusted Difference|-0.2||||0.1831|TWO_SIDED|95.0|-0.5|0.1|||ANCOVA|||Week 2, Day 14||0.10|-0.50|0.1831
72385461|NCT02833350|144278815|SUPERIORITY||Adjusted Difference|-0.31||||0.0667|TWO_SIDED|95.0|-0.65|0.02|||ANCOVA|||Week 4, Day 28||0.02|-0.65|0.0667
72385462|NCT02833350|144278815|SUPERIORITY||Adjusted Difference|-0.77|||<|0.0001|TWO_SIDED|95.0|-1.11|-0.42|||ANCOVA|||Week 8, Day 56||-0.42|-1.11|<0.0001
72385463|NCT02833350|144278815|SUPERIORITY||Adjusted Difference|-0.76||||0.0002|TWO_SIDED|95.0|-1.15|-0.38|||ANCOVA|||Week 12, Day 84||-0.38|-1.15|0.0002
72385464|NCT02833350|144278816|SUPERIORITY||Adjusted Difference|-0.18||||0.5807|TWO_SIDED|95.0|-0.55|0.19|||ANCOVA|||Week 1, Day 7||0.19|-0.55|0.5807
72385465|NCT02833350|144278816|SUPERIORITY||Adjusted Difference|-0.12||||0.627|TWO_SIDED|95.0|-0.39|0.14|||ANCOVA|||Week 1, Day 7||0.14|-0.39|0.6270
72385466|NCT02833350|144278816|SUPERIORITY||Adjusted Difference|-0.15||||0.4475|TWO_SIDED|95.0|-0.42|0.12|||ANCOVA|||Week 1, Day 7||0.12|-0.42|0.4475
72385467|NCT02833350|144278816|SUPERIORITY||Adjusted Difference|-0.06||||0.9891|TWO_SIDED|95.0|-0.47|0.35|||ANCOVA|||Week 2, Day 14||0.35|-0.47|0.9891
72385468|NCT02833350|144278816|SUPERIORITY||Adjusted Difference|-0.21||||0.2244|TWO_SIDED|95.0|-0.51|0.08|||ANCOVA|||Week 2, Day 14||0.08|-0.51|0.2244
72385469|NCT02833350|144278816|SUPERIORITY||Adjusted Difference|-0.28||||0.0586|TWO_SIDED|95.0|-0.58|0.01|||ANCOVA|||Week 2, Day 14||0.01|-0.58|0.0586
72385470|NCT02833350|144278816|SUPERIORITY||Adjusted Difference|-0.39||||0.1338|TWO_SIDED|95.0|-0.85|0.08|||ANCOVA|||Week 4, Day 28||0.08|-0.85|0.1338
72385471|NCT02833350|144278816|SUPERIORITY||Adjusted Difference|-0.4||||0.0119|TWO_SIDED|95.0|-0.74|-0.07|||ANCOVA|||Week 4, Day 28||-0.07|-0.74|0.0119
72385472|NCT02833350|144278816|SUPERIORITY||Adjusted Difference|-0.44||||0.0046|TWO_SIDED|95.0|-0.77|-0.11|||ANCOVA|||Week 4, Day 28||-0.11|-0.77|0.0046
72385473|NCT02833350|144278816|SUPERIORITY||Adjusted Difference|-0.31||||0.3943|TWO_SIDED|95.0|-0.82|0.2|||ANCOVA|||Week 8, Day 56||0.20|-0.82|0.3943
72385474|NCT02833350|144278816|SUPERIORITY||Adjusted Difference|-0.37||||0.0526|TWO_SIDED|95.0|-0.74|0.0|||ANCOVA|||Week 8, Day 56||0.00|-0.74|0.0526
72385475|NCT02833350|144278816|SUPERIORITY||Adjusted Difference|-0.39||||0.0365|TWO_SIDED|95.0|-0.76|-0.02|||ANCOVA|||Week 8, Day 56||-0.02|-0.76|0.0365
72385476|NCT02833350|144278816|SUPERIORITY||Adjusted Difference|-0.41||||0.1696|TWO_SIDED|95.0|-0.93|0.11|||ANCOVA|||Week 12, Day 84||0.11|-0.93|0.1696
72385477|NCT02833350|144278816|SUPERIORITY||Adjusted Difference|-0.63||||0.0002|TWO_SIDED|95.0|-1.01|-0.25|||ANCOVA|||Week 12, Day 84||-0.25|-1.01|0.0002
72385478|NCT02833350|144278816|SUPERIORITY||Adjusted Difference|-0.62||||0.0003|TWO_SIDED|95.0|-1.0|-0.24|||ANCOVA|||Week 12, Day 84||-0.24|-1.00|0.0003
72385479|NCT02833350|144278816|SUPERIORITY||Adjusted Difference|0.64|||<|0.0001|TWO_SIDED|95.0|0.37|0.9|||ANCOVA|||Week 1, Day 7||0.90|0.37|<0.0001
72385480|NCT02833350|144278816|SUPERIORITY||Adjusted Difference|0.61|||<|0.0001|TWO_SIDED|95.0|0.34|0.88|||ANCOVA|||Week 1, Day 7||0.88|0.34|<0.0001
72385481|NCT02833350|144278816|SUPERIORITY||Adjusted Difference|0.5||||0.0001|TWO_SIDED|95.0|0.21|0.79|||ANCOVA|||Week 2, Day 14||0.79|0.21|0.0001
72437972|NCT03034915|144388767|OTHER||Odds Ratio (OR)|1.0||||0.969|TWO_SIDED|95.0|0.8|1.26|||generalized linear mixed model||Odds Ratio (responder vs. a non-responder) comparing UMEC versus salmeterol at Week 21 to Week 24.|||1.26|0.80|0.969
72437973|NCT03034915|144388768|OTHER||Mean Difference (Net)|0.25|STANDARD_ERROR_OF_MEAN|0.672||0.709|TWO_SIDED|95.0|-1.07|1.57|||mixed model repeated measure||LS Mean difference comparing UMEC/VI versus UMEC at Week 24.|||1.57|-1.07|0.709
72437974|NCT03034915|144388768|OTHER||Mean Difference (Net)|-1.69|STANDARD_ERROR_OF_MEAN|0.665||0.011|TWO_SIDED|95.0|-2.99|-0.39|||mixed model repeated measure||LS Mean difference comparing UMEC/VI versus salmeterol at Week 24.|||-0.39|-2.99|0.011
72437975|NCT03034915|144388768|OTHER||Mean Difference (Net)|-1.94|STANDARD_ERROR_OF_MEAN|0.678||0.004|TWO_SIDED|95.0|-3.27|-0.61|||mixed model repeated measure||LS Mean difference comparing UMEC versus salmeterol at Week 24.|||-0.61|-3.27|0.004
72437976|NCT03034915|144388769|OTHER||Odds Ratio (OR)|1.21||||0.063|TWO_SIDED|95.0|0.99|1.48|||generalized linear mixed model||Odds Ratio (responder vs. a non-responder) comparing UMEC/VI versus UMEC at Week 24.|||1.48|0.99|0.063
72385482|NCT02833350|144278816|SUPERIORITY||Adjusted Difference|0.43||||0.0012|TWO_SIDED|95.0|0.14|0.72|||ANCOVA|||Week 2, Day 14||0.72|0.14|0.0012
72385483|NCT02833350|144278816|SUPERIORITY||Adjusted Difference|0.58|||<|0.0001|TWO_SIDED|95.0|0.25|0.91|||ANCOVA|||Week 4, Day 28||0.91|0.25|<0.0001
72385484|NCT02833350|144278816|SUPERIORITY||Adjusted Difference|0.54||||0.0002|TWO_SIDED|95.0|0.21|0.87|||ANCOVA|||Week 4, Day 28||0.87|0.21|0.0002
72385485|NCT02833350|144278816|SUPERIORITY||Adjusted Difference|0.46||||0.0084|TWO_SIDED|95.0|0.09|0.82|||ANCOVA|||Week 8, Day 56||0.82|0.09|0.0084
72385486|NCT02833350|144278816|SUPERIORITY||Adjusted Difference|0.44||||0.0124|TWO_SIDED|95.0|0.07|0.8|||ANCOVA|||Week 8, Day 56||0.80|0.07|0.0124
72385487|NCT02833350|144278816|SUPERIORITY||Adjusted Difference|0.15||||0.7565|TWO_SIDED|95.0|-0.23|0.52|||ANCOVA|||Week 12, Day 84||0.52|-0.23|0.7565
72385488|NCT02833350|144278816|SUPERIORITY||Adjusted Difference|0.16||||0.7158|TWO_SIDED|95.0|-0.22|0.53|||ANCOVA|||Week 12, Day 84||0.53|-0.22|0.7158
72385489|NCT02833350|144278816|SUPERIORITY||Adjusted Difference|-0.22||||0.1368|TWO_SIDED|95.0|-0.52|0.07|||ANCOVA|||Week 1, Day 7||0.07|-0.52|0.1368
72385490|NCT02833350|144278816|SUPERIORITY||Adjusted Difference|-0.28||||0.0974|TWO_SIDED|95.0|-0.62|0.05|||ANCOVA|||Week 2, Day 14||0.05|-0.62|0.0974
72385491|NCT02833350|144278816|SUPERIORITY||Adjusted Difference|-0.38||||0.0479|TWO_SIDED|95.0|-0.76|0.0|||ANCOVA|||Week 4, Day 28||-0.00|-0.76|0.0479
72385492|NCT02833350|144278816|SUPERIORITY||Adjusted Difference|-0.84|||<|0.0001|TWO_SIDED|95.0|-1.22|-0.46|||ANCOVA|||Week 8, Day 56||-0.46|-1.22|<0.0001
72385493|NCT02833350|144278816|SUPERIORITY||Adjusted Difference|-0.83||||0.0001|TWO_SIDED|95.0|-1.24|-0.42|||ANCOVA|||Week 12, Day 84||-0.42|-1.24|0.0001
72385494|NCT02833350|144278817|SUPERIORITY||Adjusted Difference|-0.09||||0.9193|TWO_SIDED|95.0|-0.41|0.24|||ANCOVA|||Week 1, Day 7||0.24|-0.41|0.9193
72385495|NCT02833350|144278817|SUPERIORITY||Adjusted Difference|-0.1||||0.7062|TWO_SIDED|95.0|-0.33|0.14|||ANCOVA|||Week 1, Day 7||0.14|-0.33|0.7062
72385496|NCT02833350|144278817|SUPERIORITY||Adjusted Difference|-0.08||||0.8542|TWO_SIDED|95.0|-0.31|0.16|||ANCOVA|||Week 1, Day 7||0.16|-0.31|0.8542
72385497|NCT02833350|144278817|SUPERIORITY||Adjusted Difference|-0.13||||0.8095|TWO_SIDED|95.0|-0.51|0.24|||ANCOVA|||Week 2, Day 14||0.24|-0.51|0.8095
72385498|NCT02833350|144278817|SUPERIORITY||Adjusted Difference|-0.17||||0.3862|TWO_SIDED|95.0|-0.44|0.11|||ANCOVA|||Week 2, Day 14||0.11|-0.44|0.3862
72385499|NCT02833350|144278817|SUPERIORITY||Adjusted Difference|-0.16||||0.4328|TWO_SIDED|95.0|-0.43|0.12|||ANCOVA|||Week 2, Day 14||0.12|-0.43|0.4328
72437977|NCT03034915|144388769|OTHER||Odds Ratio (OR)|1.49|||<|0.001|TWO_SIDED|95.0|1.22|1.83|||generalized linear mixed model||Odds Ratio (responder vs. a non-responder) comparing UMEC/VI versus salmeterol at Week 24.|||1.83|1.22|<0.001
72437978|NCT03034915|144388769|OTHER||Odds Ratio (OR)|1.23||||0.045|TWO_SIDED|95.0|1.0|1.51|||generalized linear mixed model||Odds Ratio (responder vs. a non-responder) comparing UMEC versus salmeterol at Week 24.|||1.51|1.00|0.045
72437979|NCT03034915|144388770|OTHER||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|0.3||0.891|TWO_SIDED|95.0|-0.6|0.6|||mixed model repeated measures||LS Mean difference comparing UMEC/VI versus UMEC at Week 24.|||0.6|-0.6|0.891
72437980|NCT03034915|144388770|OTHER||Mean Difference (Net)|-0.5|STANDARD_ERROR_OF_MEAN|0.3||0.074|TWO_SIDED|95.0|-1.1|0.1|||mixed model repeated measures||LS Mean difference comparing UMEC/VI versus salmeterol at Week 24.|||0.1|-1.1|0.074
72437981|NCT03034915|144388770|OTHER||Odds Ratio (OR)|-0.5|STANDARD_ERROR_OF_MEAN|0.31||0.107|TWO_SIDED|95.0|-1.1|0.1|||mixed model repeated measures||LS Mean difference comparing UMEC versus salmeterol at Week 24.|||0.1|-1.1|0.107
72437982|NCT03034915|144388771|OTHER||Odds Ratio (OR)|1.35||||0.003|TWO_SIDED|95.0|1.11|1.65|||generalized linear mixed model||Odds Ratio (responder vs. a non-responder) comparing UMEC/VI versus UMEC at Week 24.|||1.65|1.11|0.003
72437983|NCT03034915|144388771|OTHER||Odds Ratio (OR)|1.23||||0.037|TWO_SIDED|95.0|1.01|1.5|||generalized linear mixed model||Odds Ratio (responder vs. a non-responder) comparing UMEC/VI versus salmeterol at Week 24.|||1.50|1.01|0.037
72437984|NCT03034915|144388771|OTHER||Odds Ratio (OR)|0.91||||0.363|TWO_SIDED|95.0|0.75|1.11|||generalized linear mixed model||Odds Ratio (responder vs. a non-responder) comparing UMEC versus salmeterol at Week 24.|||1.11|0.75|0.363
72495200|NCT02475655|144519391|SUPERIORITY||Mean Difference (Net)|-3.24||||0.008|TWO_SIDED|90.0|-5.22|-1.27||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in the expression of CD38+HLADR+ among CD8+ T-cells from Entry to Week 5.||-1.27|-5.22|0.008
72495201|NCT02475655|144519391|SUPERIORITY||Median Difference (Net)|-0.17||||0.9|TWO_SIDED|90.0|-2.38|2.05||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in the expression of CD38+HLADR+ among CD8+ T-cells from Entry to Week 12.||2.05|-2.38|0.90
72495202|NCT02475655|144519394|SUPERIORITY||Mean Difference (Net)|1.39||||0.47|TWO_SIDED|90.0|-1.83|4.61||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in classical monocytes (CD14+CD16-) from Entry to Week 5.||4.61|-1.83|0.47
72558687|NCT00521586|144647378|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.9|||||TWO_SIDED|95.0|0.75|1.08||||||Serotype 3: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution.||1.08|0.75|
72437985|NCT02138006|144388773|SUPERIORITY_OR_OTHER|||||||0.3|TWO_SIDED||||||Log Rank|||||||0.30
72437986|NCT03861767|144388775|SUPERIORITY||Odds Ratio (OR)|1.14|||||TWO_SIDED|95.0|0.67|1.97||||||Low dose groups collapsed and compared to placebo||1.97|0.67|
72437987|NCT03861767|144388775|SUPERIORITY||Odds Ratio (OR)|0.72|||||TWO_SIDED|95.0|0.42|1.25||||||Intermediate dose groups were collapsed and compared to placebo||1.25|0.42|
72437988|NCT03861767|144388775|SUPERIORITY||Odds Ratio (OR)|1.06|||||TWO_SIDED|95.0|0.61|1.84||||||High dose groups were collapsed and compared to placebo||1.84|0.61|
72437989|NCT03861767|144388776|SUPERIORITY||Odds Ratio (OR)|1.03||||0.92|TWO_SIDED|95.0|0.52|2.03|||Regression, Logistic|||All intervention groups were grouped together and compared to placebo||2.03|0.52|0.92
72437990|NCT03861767|144388777|SUPERIORITY||Odds Ratio (OR)|1.08||||0.8|TWO_SIDED|95.0|0.52|2.0|||Regression, Logistic|||All intervention groups were grouped together and compared to placebo||2.00|0.52|0.80
72437991|NCT03861767|144388778|SUPERIORITY||Odds Ratio (OR)|1.23||||0.65|TWO_SIDED|95.0|0.49|3.11|||Regression, Logistic|||All intervention groups were grouped together and compared to placebo||3.11|0.49|0.65
72437992|NCT03861767|144388779|SUPERIORITY||Odds Ratio (OR)|1.62||||0.23|TWO_SIDED|95.0|0.73|3.62|||Regression, Logistic|||All intervention groups were grouped together and compared to placebo||3.62|0.73|0.23
72437993|NCT03861767|144388780|SUPERIORITY||Odds Ratio (OR)|1.42||||0.31|TWO_SIDED|95.0|0.71|2.86|||Regression, Logistic|||All intervention groups were grouped together and compared to placebo||2.86|0.71|0.31
72437994|NCT03861767|144388781|SUPERIORITY||Beta-coefficient|0.0011|STANDARD_ERROR_OF_MEAN|0.042||0.97|TWO_SIDED||||||Regression, Linear|||All intervention groups were grouped together and compared to placebo||||0.97
72437995|NCT03861767|144388782|SUPERIORITY||Beta-coefficient|-0.76|STANDARD_ERROR_OF_MEAN|0.74||0.3|TWO_SIDED||||||Regression, Linear|||All intervention groups were grouped together and compared to placebo||||0.30
72437996|NCT03861767|144388783|SUPERIORITY||Beta-coefficient|0.27|STANDARD_ERROR_OF_MEAN|0.59||0.65|TWO_SIDED||||||Regression, Linear|||All intervention groups were grouped together and compared to placebo||||0.65
72437997|NCT03861767|144388785|SUPERIORITY||Odds Ratio (OR)|1.45||||0.27|TWO_SIDED|95.0|0.74|2.86|||Regression, Logistic|||||2.86|0.74|0.27
72437998|NCT03861767|144388786|SUPERIORITY||Odds Ratio (OR)|2.98||||0.01|TWO_SIDED|95.0|1.19|7.44|||Regression, Logistic|||All intervention groups were collapsed and compared to placebo||7.44|1.19|0.01
72495203|NCT02475655|144519394|SUPERIORITY||Mean Difference (Net)|2.21||||0.22|TWO_SIDED|90.0|-0.77|5.18||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in classical monocytes (CD14+CD16-) from Entry to Week 12.||5.18|-0.77|0.22
72495204|NCT02475655|144519395|SUPERIORITY||Mean Difference (Net)|-4.34||||0.28|TWO_SIDED|90.0|-11.0|2.35||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in classical monocytes (CD14+CD16-) expressing CD163+ from Entry to Week 5.||2.35|-11.0|0.28
72495205|NCT02475655|144519395|SUPERIORITY||Mean Difference (Net)|-9.81||||0.019|TWO_SIDED|90.0|-16.6|-3.02||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in classical monocytes (CD14+CD16-) expressing CD163+ from Entry to Week 12.||-3.02|-16.6|0.019
72558688|NCT00521586|144647378|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.1|||||TWO_SIDED|95.0|0.92|1.28||||||Serotype 4: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution.||1.28|0.92|
72558689|NCT00521586|144647378|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.9|||||TWO_SIDED|95.0|0.68|1.08||||||Serotype 5: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution.||1.08|0.68|
72437999|NCT03861767|144388787|SUPERIORITY||Odds Ratio (OR)|2.67|||<|0.01|TWO_SIDED|95.0|1.34|5.3|||Regression, Logistic|||All intervention groups were collapsed and compared to placebo||5.30|1.34|<0.01
72438000|NCT03861767|144388788|SUPERIORITY||Odds Ratio (OR)|0.9||||0.72|TWO_SIDED|95.0|0.52|1.56|||Regression, Logistic|||All intervention groups were collapsed into one group and compared with placebo. Patients were compared whether they were discharged home or other.||1.56|0.52|0.72
72438001|NCT01087762|144388790|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|19.3|||=|0.004|TWO_SIDED|95.0|6.3|32.4||Difference of Certolizumab Pegol 200 mg versus Placebo (and corresponding 95 % Confidence Interval and p-value) were estimated using a standard two-sided Wald asymptotic test with a 5 % alpha level.|Wald-test, 2-sided|Wald test and Confidence Interval (CI) calculation were performed without continuity correction.||A hierarchical test procedure was applied to protect the overall significance level for the multiplicity of dose groups and endpoints. Conditional on the first test being significant, the second hypothesis was tested with the same alpha level of 5 %. Statistical testing for the following hypotheses was performed only if the previous null hypothesis in the hierarchy was rejected.||32.4|6.3|=0.004
72495206|NCT02475655|144519396|SUPERIORITY||Mean Difference (Net)|-0.81||||0.55|TWO_SIDED|90.0|-3.02|1.41||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in classical monocytes (CD14+CD16-) expressing CCR2+ from Entry to Week 5.||1.41|-3.02|0.55
72495207|NCT02475655|144519396|SUPERIORITY||Mean Difference (Net)|-1.7||||0.09|TWO_SIDED|90.0|-3.36|-0.04||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in classical monocytes (CD14+CD16-) expressing CCR2+ from Entry to Week 12.||-0.04|-3.36|0.09
72558690|NCT00521586|144647378|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.1|||||TWO_SIDED|95.0|0.88|1.3||||||Serotype 6A: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution.||1.30|0.88|
72558691|NCT00521586|144647378|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.0|||||TWO_SIDED|95.0|0.84|1.21||||||Serotype 6B: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution.||1.21|0.84|
72558692|NCT00521586|144647378|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.9|||||TWO_SIDED|95.0|0.78|1.06||||||Serotype 7F: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution.||1.06|0.78|
72558693|NCT00521586|144647378|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.2|||||TWO_SIDED|95.0|0.93|1.48||||||Serotype 9V: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution.||1.48|0.93|
72558694|NCT00521586|144647378|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.0|||||TWO_SIDED|95.0|0.86|1.17||||||Serotype 14: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution.||1.17|0.86|
72558695|NCT00521586|144647378|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.0|||||TWO_SIDED|95.0|0.84|1.27||||||Serotype 18C: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution.||1.27|0.84|
72558696|NCT00521586|144647378|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.0|||||TWO_SIDED|95.0|0.87|1.21||||||Serotype 19A: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution.||1.21|0.87|
72558697|NCT00521586|144647378|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.1|||||TWO_SIDED|95.0|0.85|1.31||||||Serotype 19F: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution.||1.31|0.85|
72558698|NCT00521586|144647378|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.0|||||TWO_SIDED|95.0|0.8|1.27||||||Serotype 23F: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution.||1.27|0.80|
72558699|NCT00521586|144647387|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.01|||||TWO_SIDED|95.0|0.87|1.18||||||Serotype 1: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution.||1.18|0.87|
72385500|NCT02833350|144278817|SUPERIORITY||Adjusted Difference|-0.24||||0.4915|TWO_SIDED|95.0|-0.68|0.2|||ANCOVA|||Week 4, Day 28||0.20|-0.68|0.4915
72385501|NCT02833350|144278817|SUPERIORITY||Adjusted Difference|-0.26||||0.1441|TWO_SIDED|95.0|-0.58|0.06|||ANCOVA|||Week 4, Day 28||0.06|-0.58|0.1441
72385502|NCT02833350|144278817|SUPERIORITY||Adjusted Difference|-0.24||||0.189|TWO_SIDED|95.0|-0.56|0.07|||ANCOVA|||Week 4, Day 28||0.07|-0.56|0.1890
72385503|NCT02833350|144278817|SUPERIORITY||Adjusted Difference|-0.25||||0.5566|TWO_SIDED|95.0|-0.74|-0.24|||ANCOVA|||Week 8, Day 56||-0.24|-0.74|0.5566
72385504|NCT02833350|144278817|SUPERIORITY||Adjusted Difference|-0.32||||0.092|TWO_SIDED|95.0|-0.68|0.04|||ANCOVA|||Week 8, Day 56||0.04|-0.68|0.0920
72385505|NCT02833350|144278817|SUPERIORITY||Adjusted Difference|-0.29||||0.1391|TWO_SIDED|95.0|-0.65|0.06|||ANCOVA|||Week 8, Day 56||0.06|-0.65|0.1391
72385506|NCT02833350|144278817|SUPERIORITY||Adjusted Difference|-0.35||||0.2873|TWO_SIDED|95.0|-0.86|0.17|||ANCOVA|||Week 12, Day 84||0.17|-0.86|0.2873
72385507|NCT02833350|144278817|SUPERIORITY||Adjusted Difference|-0.54||||0.002|TWO_SIDED|95.0|-0.91|-0.16|||ANCOVA|||Week 12, Day 84||-0.16|-0.91|0.0020
72385508|NCT02833350|144278817|SUPERIORITY||Adjusted Difference|-0.54||||0.0016|TWO_SIDED|95.0|-0.92|-0.17|||ANCOVA|||Week 12, Day 84||-0.17|-0.92|0.0016
72385509|NCT02833350|144278817|SUPERIORITY||Adjusted Difference|0.31||||0.005|TWO_SIDED|95.0|0.07|0.55|||ANCOVA|||Week 1, Day 7||0.55|0.07|0.0050
72385510|NCT02833350|144278817|SUPERIORITY||Adjusted Difference|0.33||||0.002|TWO_SIDED|95.0|0.1|0.57|||ANCOVA|||Week 1, Day 7||0.57|0.10|0.0020
72438002|NCT01087762|144388790|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|25.2|||<|0.001|TWO_SIDED|95.0|12.3|38.2||Difference of Certolizumab Pegol 400 mg versus Placebo (and corresponding 95 % Confidence Interval and p-value) were estimated using a standard two-sided Wald asymptotic test with a 5 % alpha level.|Wald-test, 2-sided|Wald test and Confidence Interval (CI) calculation were performed without continuity correction.||A hierarchical test procedure was applied to protect the overall significance level for the multiplicity of dose groups and endpoints. Conditional on the first test being significant, the second hypothesis was tested with the same alpha level of 5 %. Statistical testing for the following hypotheses was performed only if the previous null hypothesis in the hierarchy was rejected.||38.2|12.3|<0.001
72438003|NCT01087762|144388791|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|37.7|||<|0.001|TWO_SIDED|95.0|25.4|50.0||Difference of Certolizumab Pegol 200 mg versus Placebo (and corresponding 95 % Confidence Interval and p-value) were estimated using a standard two-sided Wald asymptotic test with a 5 % alpha level.|Wald-test, 2-sided|Wald test and Confidence Interval (CI) calculation were performed without continuity correction.||A hierarchical test procedure was applied to protect the overall significance level for the multiplicity of dose groups and endpoints. Conditional on the first test being significant, the second hypothesis was tested with the same alpha level of 5 %. Statistical testing for the following hypotheses was performed only if the previous null hypothesis in the hierarchy was rejected.||50.0|25.4|<0.001
72385511|NCT02833350|144278817|SUPERIORITY||Adjusted Difference|0.35||||0.0082|TWO_SIDED|95.0|0.07|0.62|||ANCOVA|||Week 2, Day 14||0.62|0.07|0.0082
72385512|NCT02833350|144278817|SUPERIORITY||Adjusted Difference|0.35||||0.0056|TWO_SIDED|95.0|0.08|0.63|||ANCOVA|||Week 2, Day 14||0.63|0.08|0.0056
72385513|NCT02833350|144278817|SUPERIORITY||Adjusted Difference|0.5||||0.0004|TWO_SIDED|95.0|0.19|0.82|||ANCOVA|||Week 4, Day 28||0.82|0.19|0.0004
72385514|NCT02833350|144278817|SUPERIORITY||Adjusted Difference|0.52||||0.0002|TWO_SIDED|95.0|0.21|0.84|||ANCOVA|||Week 4, Day 28||0.84|0.21|0.0002
72385515|NCT02833350|144278817|SUPERIORITY||Adjusted Difference|0.34||||0.065|TWO_SIDED|95.0|-0.01|0.69|||ANCOVA|||Week 8, Day 56||0.69|-0.01|0.0650
72385516|NCT02833350|144278817|SUPERIORITY||Adjusted Difference|0.37||||0.0365|TWO_SIDED|95.0|0.02|0.72|||ANCOVA|||Week 8, Day 56||0.72|0.02|0.0365
72385517|NCT02833350|144278817|SUPERIORITY||Adjusted Difference|0.09||||0.9338|TWO_SIDED|95.0|-0.28|0.47|||ANCOVA|||Week 12, Day 84||0.47|-0.28|0.9338
72385518|NCT02833350|144278817|SUPERIORITY||Adjusted Difference|0.09||||0.952|TWO_SIDED|95.0|-0.29|0.46|||ANCOVA|||Week 12, Day 84||0.46|-0.29|0.9520
72385519|NCT02833350|144278817|SUPERIORITY||Adjusted Difference|-0.19||||0.1496|TWO_SIDED|95.0|-0.45|0.07|||ANCOVA|||Week 1, Day 7||0.07|-0.45|0.1496
72385520|NCT02833350|144278817|SUPERIORITY||Adjusted Difference|-0.13||||0.3936|TWO_SIDED|95.0|-0.43|0.17|||ANCOVA|||Week 2, Day 14||0.17|-0.43|0.3936
72385521|NCT02833350|144278817|SUPERIORITY||Adjusted Difference|-0.35||||0.0346|TWO_SIDED|95.0|-0.68|-0.03|||ANCOVA|||Week 4, Day 28||-0.03|-0.68|0.0346
72385522|NCT02833350|144278817|SUPERIORITY||Adjusted Difference|-0.68||||0.0004|TWO_SIDED|95.0|-1.04|-0.31|||ANCOVA|||Week 8, Day 56||-0.31|-1.04|0.0004
72385523|NCT02833350|144278817|SUPERIORITY||Adjusted Difference|-0.73||||0.0003|TWO_SIDED|95.0|-1.11|-0.34|||ANCOVA|||Week 12, Day 84||-0.34|-1.11|0.0003
72385524|NCT02833350|144278818|SUPERIORITY||Adjusted Difference|-0.17||||0.6083|TWO_SIDED|95.0|-0.53|0.19|||ANCOVA|||Week 1, Day 7||0.19|-0.53|0.6083
72385525|NCT02833350|144278818|SUPERIORITY||Adjusted Difference|-0.18||||0.2672|TWO_SIDED|95.0|-0.44|0.08|||ANCOVA|||Week 1, Day 7||0.08|-0.44|0.2672
72385526|NCT02833350|144278818|SUPERIORITY||Adjusted Difference|-0.17||||0.3158|TWO_SIDED|95.0|-0.43|0.09|||ANCOVA|||Week 1, Day 7||0.09|-0.43|0.3158
72385527|NCT02833350|144278818|SUPERIORITY||Adjusted Difference|-0.14||||0.8495|TWO_SIDED|95.0|-0.55|0.28|||ANCOVA|||Week 2, Day 14||0.28|-0.55|0.8495
72385528|NCT02833350|144278818|SUPERIORITY||Adjusted Difference|-0.28||||0.0856|TWO_SIDED|95.0|-0.58|0.03|||ANCOVA|||Week 2, Day 14||0.03|-0.58|0.0856
72385529|NCT02833350|144278818|SUPERIORITY||Adjusted Difference|-0.27||||0.1021|TWO_SIDED|95.0|-0.57|0.04|||ANCOVA|||Week 2, Day 14||0.04|-0.57|0.1021
72385530|NCT02833350|144278818|SUPERIORITY||Adjusted Difference|-0.33||||0.2762|TWO_SIDED|95.0|-0.82|0.15|||ANCOVA|||Week 4, Day 28||0.15|-0.82|0.2762
72385531|NCT02833350|144278818|SUPERIORITY||Adjusted Difference|-0.38||||0.0286|TWO_SIDED|95.0|-0.73|-0.03|||ANCOVA|||Week 4, Day 28||-0.03|-0.73|0.0286
72385532|NCT02833350|144278818|SUPERIORITY||Adjusted Difference|-0.38||||0.0274|TWO_SIDED|95.0|-0.73|-0.03|||ANCOVA|||Week 4, Day 28||-0.03|-0.73|0.0274
72385533|NCT02833350|144278818|SUPERIORITY||Adjusted Difference|-0.28||||0.4981|TWO_SIDED|95.0|-0.81|0.24|||ANCOVA|||Week 8, Day 56||0.24|-0.81|0.4981
72385534|NCT02833350|144278818|SUPERIORITY||Adjusted Difference|-0.39||||0.0472|TWO_SIDED|95.0|-0.78|0.0|||ANCOVA|||Week 8, Day 56||-0.00|-0.78|0.0472
72438004|NCT01087762|144388791|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|41.1|||<|0.001|TWO_SIDED|95.0|28.9|53.3||Difference of Certolizumab Pegol 400 mg versus Placebo (and corresponding 95 % Confidence Interval and p-value) were estimated using a standard two-sided Wald asymptotic test with a 5 % alpha level.|Wald-test, 2-sided|Wald test and Confidence Interval (CI) calculation were performed without continuity correction.||A hierarchical test procedure was applied to protect the overall significance level for the multiplicity of dose groups and endpoints. Conditional on the first test being significant, the second hypothesis was tested with the same alpha level of 5 %. Statistical testing for the following hypotheses was performed only if the previous null hypothesis in the hierarchy was rejected.||53.3|28.9|<0.001
72438005|NCT01087762|144388792|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.49|STANDARD_ERROR_OF_MEAN|0.24|<|0.001|TWO_SIDED|95.0|-1.96|-1.01||Difference of CZP 200 mg + 400 mg vs. Placebo was estimated using an ANCOVA model with treatment, region, modified New York criteria and prior TNF-antagonist exposure as factors and Baseline BASFI score as a covariate.|ANCOVA|||A hierarchical test procedure was applied to protect the overall significance level for the multiplicity of dose groups and endpoints. Conditional on the first test being significant, the second hypothesis was tested with the same alpha level of 5 %. Statistical testing for the following hypotheses was performed only if the previous null hypothesis in the hierarchy was rejected.||-1.01|-1.96|<0.001
72438006|NCT01087762|144388793|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.88|STANDARD_ERROR_OF_MEAN|0.25|<|0.001|TWO_SIDED|95.0|-2.38|-1.38||Difference of CZP 200 mg + 400 mg vs. Placebo was estimated using an ANCOVA model with treatment, region, modified New York criteria and prior TNF-antagonist exposure as factors and Baseline BASFI score as a covariate.|ANCOVA|||A hierarchical test procedure was applied to protect the overall significance level for the multiplicity of dose groups and endpoints. Conditional on the first test being significant, the second hypothesis was tested with the same alpha level of 5 %. Statistical testing for the following hypotheses was performed only if the previous null hypothesis in the hierarchy was rejected.||-1.38|-2.38|<0.001
72438007|NCT01087762|144388794|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.6|STANDARD_ERROR_OF_MEAN|0.24|<|0.001|TWO_SIDED|95.0|-2.07|-1.12||Difference of CZP 200 mg + 400 mg vs. Placebo was estimated using an ANCOVA model with treatment, region, modified New York criteria and prior TNF-antagonist exposure as factors and Baseline BASDAI score as a covariate.|ANCOVA|||A hierarchical test procedure was applied to protect the overall significance level for the multiplicity of dose groups and endpoints. Conditional on the first test being significant, the second hypothesis was tested with the same alpha level of 5 %. Statistical testing for the following hypotheses was performed only if the previous null hypothesis in the hierarchy was rejected.||-1.12|-2.07|<0.001
72438008|NCT01087762|144388795|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.99|STANDARD_ERROR_OF_MEAN|0.25|<|0.001|TWO_SIDED|95.0|-2.49|-1.5||Difference of CZP 200 mg + 400 mg vs. Placebo was estimated using an ANCOVA model with treatment, region, modified New York criteria and prior TNF-antagonist exposure as factors and Baseline BASDAI score as a covariate.|ANCOVA|||A hierarchical test procedure was applied to protect the overall significance level for the multiplicity of dose groups and endpoints. Conditional on the first test being significant, the second hypothesis was tested with the same alpha level of 5 %. Statistical testing for the following hypotheses was performed only if the previous null hypothesis in the hierarchy was rejected.||-1.50|-2.49|<0.001
72438009|NCT01087762|144388796|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.6|-0.2||Difference of CZP 200 mg + 400 mg vs. Placebo was estimated using an ANCOVA model with treatment, region, modified New York criteria and prior TNF-antagonist exposure as factors and Baseline BASMI score as a covariate.|ANCOVA|||A hierarchical test procedure was applied to protect the overall significance level for the multiplicity of dose groups and endpoints. Conditional on the first test being significant, the second hypothesis was tested with the same alpha level of 5 %. Statistical testing for the following hypotheses was performed only if the previous null hypothesis in the hierarchy was rejected.||-0.20|-0.60|<0.001
72438010|NCT01087762|144388797|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.44|STANDARD_ERROR_OF_MEAN|0.11|<|0.001|TWO_SIDED|95.0|-0.66|-0.23||Difference of CZP 200 mg + 400 mg vs. Placebo was estimated using an ANCOVA model with treatment, region, modified New York criteria and prior TNF-antagonist exposure as factors and Baseline BASMI score as a covariate.|ANCOVA|||A hierarchical test procedure was applied to protect the overall significance level for the multiplicity of dose groups and endpoints. Conditional on the first test being significant, the second hypothesis was tested with the same alpha level of 5 %. Statistical testing for the following hypotheses was performed only if the previous null hypothesis in the hierarchy was rejected.||-0.23|-0.66|<0.001
72558700|NCT00521586|144647387|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.95|||||TWO_SIDED|95.0|0.82|1.1||||||Serotype 3: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution.||1.10|0.82|
72558701|NCT00521586|144647387|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.03|||||TWO_SIDED|95.0|0.88|1.21||||||Serotype 4: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution.||1.21|0.88|
72558702|NCT00521586|144647387|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.93|||||TWO_SIDED|95.0|0.8|1.09||||||Serotype 5: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution.||1.09|0.80|
72558703|NCT00521586|144647387|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.01|||||TWO_SIDED|95.0|0.84|1.22||||||Serotype 6A: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution.||1.22|0.84|
72558704|NCT00521586|144647387|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.93|||||TWO_SIDED|95.0|0.77|1.12||||||Serotype 6B: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution.||1.12|0.77|
72558705|NCT00521586|144647387|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.97|||||TWO_SIDED|95.0|0.85|1.11||||||Serotype 7F: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution.||1.11|0.85|
72385535|NCT02833350|144278818|SUPERIORITY||Adjusted Difference|-0.36||||0.0753|TWO_SIDED|95.0|-0.75|0.03|||ANCOVA|||Week 8, Day 56||0.03|-0.75|0.0753
72438011|NCT01188499|144388803|SUPERIORITY_OR_OTHER||Percent|100.0|||||TWO_SIDED||||||||Primary objective of safety and tolerability measured by percent participants experiencing at least one adverse event. No formal statistics performed.|||||
72438012|NCT01188499|144388804|SUPERIORITY_OR_OTHER||Percent|10.0|||||TWO_SIDED||||||||Percent patients overall across all five arms demonstrating complete or partial response by RECIST. No formal statistics performed.|||||
72438013|NCT00424762|144388806|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||t-test, 2 sided|||powered to detect at least 33% difference between groups||||>0.05
72438014|NCT00424762|144388807|SUPERIORITY_OR_OTHER|||||||0.26|||||||t-test, 2 sided|||powered to detect difference of at least 10% between groups||||0.26
72438015|NCT00424762|144388808|SUPERIORITY_OR_OTHER|||||||0.03||95.0|||||Chi-squared|||comparative incidence||||0.03
72438016|NCT02311972|144388809|SUPERIORITY|Mean axillary admission temperature||||||0.7294|||||||t-test, 2 sided|||||||0.7294
72558706|NCT00521586|144647387|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.93|||||TWO_SIDED|95.0|0.81|1.07||||||Serotype 9V: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution.||1.07|0.81|
72385536|NCT02833350|144278818|SUPERIORITY||Adjusted Difference|-0.43||||0.1853|TWO_SIDED|95.0|-0.99|0.13|||ANCOVA|||Week 12, Day 84||0.13|-0.99|0.1853
72385537|NCT02833350|144278818|SUPERIORITY||Adjusted Difference|-0.62||||0.0009|TWO_SIDED|95.0|-1.03|-0.21|||ANCOVA|||Week 12, Day 84||-0.21|-1.03|0.0009
72385538|NCT02833350|144278818|SUPERIORITY||Adjusted Difference|-0.62||||0.0008|TWO_SIDED|95.0|-1.03|-0.21|||ANCOVA|||Week 12, Day 84||-0.21|-1.03|0.0008
72385539|NCT02833350|144278818|SUPERIORITY||Adjusted Difference|0.41||||0.0005|TWO_SIDED|95.0|0.15|0.67|||ANCOVA|||Week 1, Day 7||0.67|0.15|0.0005
72438017|NCT02311972|144388810|SUPERIORITY|||||||0.236|||||||t-test, 2 sided|||||||0.2360
72438018|NCT02311972|144388811|SUPERIORITY|||||||0.05|||||||t-test, 2 sided|||||||0.05
72438019|NCT02311972|144388812|SUPERIORITY|||||||0.1089|||||||t-test, 2 sided|||||||0.1089
72438020|NCT02311972|144388813|SUPERIORITY|||||||0.05|||||||t-test, 2 sided|||||||0.05
72438021|NCT02311972|144388814|SUPERIORITY|||||||0.4947|||||||t-test, 2 sided|||||||0.4947
72438022|NCT02311972|144388815|SUPERIORITY|Infant 007|||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
72438023|NCT02311972|144388815|SUPERIORITY|Infant 010|||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
72438024|NCT02311972|144388815|SUPERIORITY|Infant 015|||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
72438025|NCT02311972|144388815|SUPERIORITY|Infant 039|||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
72438026|NCT02311972|144388815|SUPERIORITY|Infant 040||||||0.3947|||||||t-test, 2 sided|||||||0.3947
72438027|NCT03557658|144388848|EQUIVALENCE|The acceptance range for bioequivalence is 80.0 - 125.00%.|Point Estimate|106.22|||||TWO_SIDED|90.0|78.34|144.02|||||Point Estimate is the estimated ratio of exponentiated mean difference of log-transformed PK parameter from ANOVA. Confidence interval is obtained from ANOVA with hepatic function group as a fixed effect, and the subject as a random effect.|Geometric LS Mean was used as PK parameters for total bexagliflozin by hepatic function group.||144.02|78.34|
72438028|NCT03557658|144388848|EQUIVALENCE|The acceptance range for bioequivalence is 80.00 - 125.00%.|Point Estimate|110.84|||||TWO_SIDED|90.0|75.34|163.06|||||Point Estimate is the estimated ratio of exponentiated mean difference of log-transformed PK parameter from ANOVA. Confidence interval is obtained from ANOVA with hepatic function group as a fixed effect, and the subject as a random effect.|Geometric LS Mean was used as PK parameters for unbound bexagliflozin by hepatic function group||163.06|75.34|
72438029|NCT03557658|144388851|EQUIVALENCE|The acceptance range for bioequivalence is 80.00 - 125.00%.|Point Estimate|128.34|||||TWO_SIDED|90.0|99.98|164.73|||||Point Estimate is the estimated ratio of exponentiated mean difference of log-transformed PK parameter from ANOVA. Confidence interval is obtained from ANOVA with hepatic function group as a fixed effect, and the subject as a random effect.|Geometric LS Mean was used as PK parameters for total bexagliflozin by hepatic function group||164.73|99.98|
72438030|NCT03557658|144388851|EQUIVALENCE|The acceptance range for bioequivalence is 80.00 - 125.00%.|Point Estimate|132.16|||||TWO_SIDED|90.0|96.46|181.08|||||Point Estimate is the estimated ratio of exponentiated mean difference of log-transformed PK parameter from ANOVA. Confidence interval is obtained from ANOVA with hepatic function group as a fixed effect, and the subject as a random effect.|Geometric LS Mean was used as PK parameters for unbound bexagliflozin by hepatic function group||181.08|96.46|
72438031|NCT03478696|144388865|NON_INFERIORITY|Non-inferiority was to be demonstrated, if the lower bound of the two-sided 95 percentage (%) confidence interval around the (FF/UMEC/VI versus BUD/FOR+TIO) treatment difference was above -50 milliliter.|Mean Difference (Net)|0.011|STANDARD_ERROR_OF_MEAN|0.0154|||TWO_SIDED|95.0|-0.02|0.041|||||The primary treatment effect estimated (hypothetical effect) excluded data following intercurrent events: discontinuation of treatment, taking wrong treatment, taking prohibited medication, unblinding, noncompliance, COPD exacerbation or pneumonia.|||0.041|-0.020|
72438032|NCT03478696|144388866|SUPERIORITY||Mean Difference (Net)|0.026|STANDARD_ERROR_OF_MEAN|0.0122||0.037|TWO_SIDED|95.0|0.002|0.049||Only if superiority is achieved on the primary study endpoint, then inferences can be made on change from Baseline in trough FEV1 on Day 2 using p-values.|Mixed model repeated measures||Day 2|||0.049|0.002|0.037
72438033|NCT03478696|144388866|SUPERIORITY||Mean Difference (Net)|0.063|STANDARD_ERROR_OF_MEAN|0.0134|<|0.001|TWO_SIDED|95.0|0.036|0.089||Only if superiority is achieved on the primary study endpoint, then inferences can be made on change from Baseline in trough FEV1 on Day 28 using p-values.|Mixed model repeated measures||Day 28|||0.089|0.036|<0.001
72438034|NCT03478696|144388866|SUPERIORITY||Mean Difference (Net)|0.054|STANDARD_ERROR_OF_MEAN|0.0144|<|0.001|TWO_SIDED|95.0|0.026|0.083||Only if superiority is achieved on the primary study endpoint, then inferences can be made on change from Baseline in trough FEV1 on Day 84 using p-values.|Mixed model repeated measures||Day 84|||0.083|0.026|<0.001
72385540|NCT02833350|144278818|SUPERIORITY||Adjusted Difference|0.42||||0.0003|TWO_SIDED|95.0|0.16|0.68|||ANCOVA|||Week 1, Day 7||0.68|0.16|0.0003
72385541|NCT02833350|144278818|SUPERIORITY||Adjusted Difference|0.39||||0.006|TWO_SIDED|95.0|0.09|0.69|||ANCOVA|||Week 2, Day 14||0.69|0.09|0.0060
72385542|NCT02833350|144278818|SUPERIORITY||Adjusted Difference|0.4||||0.0039|TWO_SIDED|95.0|0.1|0.7|||ANCOVA|||Week 2, Day 14||0.70|0.10|0.0039
72385543|NCT02833350|144278818|SUPERIORITY||Adjusted Difference|0.53||||0.0007|TWO_SIDED|95.0|0.18|0.88|||ANCOVA|||Week 4, Day 28||0.88|0.18|0.0007
72385544|NCT02833350|144278818|SUPERIORITY||Adjusted Difference|0.53||||0.0007|TWO_SIDED|95.0|0.19|0.88|||ANCOVA|||Week 4, Day 28||0.88|0.19|0.0007
72385545|NCT02833350|144278818|SUPERIORITY||Adjusted Difference|0.39||||0.045|TWO_SIDED|95.0|0.01|0.77|||ANCOVA|||Week 8, Day 56||0.77|0.01|0.0450
72385546|NCT02833350|144278818|SUPERIORITY||Adjusted Difference|0.42||||0.0259|TWO_SIDED|95.0|0.04|0.8|||ANCOVA|||Week 8, Day 56||0.80|0.04|0.0259
72385547|NCT02833350|144278818|SUPERIORITY||Adjusted Difference|0.06||||0.9881|TWO_SIDED|95.0|-0.34|0.46|||ANCOVA|||Week 12, Day 84||0.46|-0.34|0.9881
72385548|NCT02833350|144278818|SUPERIORITY||Adjusted Difference|0.06||||0.9891|TWO_SIDED|95.0|-0.34|0.46|||ANCOVA|||Week 12, Day 84||0.46|-0.34|0.9891
72385549|NCT02833350|144278818|SUPERIORITY||Adjusted Difference|-0.29||||0.0463|TWO_SIDED|95.0|-0.57|0.0|||ANCOVA|||Week 1, Day 7||-0.00|-0.57|0.0463
72385550|NCT02833350|144278818|SUPERIORITY||Adjusted Difference|-0.23||||0.1867|TWO_SIDED|95.0|-0.56|0.11|||ANCOVA|||Week 2, Day 14||0.11|-0.56|0.1867
72385551|NCT02833350|144278818|SUPERIORITY||Adjusted Difference|-0.44||||0.0213|TWO_SIDED|95.0|-0.81|-0.07|||ANCOVA|||Week 4, Day 28||-0.07|-0.81|0.0213
72385552|NCT02833350|144278818|SUPERIORITY||Adjusted Difference|-0.78||||0.0003|TWO_SIDED|95.0|-1.19|-0.37|||ANCOVA|||Week 8. Day 56||-0.37|-1.19|0.0003
72385553|NCT02833350|144278818|SUPERIORITY||Adjusted Difference|-0.82||||0.0002|TWO_SIDED|95.0|-1.24|-0.4|||ANCOVA|||Week 12, Day 84||-0.40|-1.24|0.0002
72385554|NCT02833350|144278819|SUPERIORITY||Adjusted Difference|0.0||||1|TWO_SIDED|95.0|-6.06|6.06|||Cochran-Mantel-Haenszel|||Week 1, Day 7||6.06|-6.06|1.0000
72385555|NCT02833350|144278819|SUPERIORITY||Adjusted Difference|0.91||||0.5976|TWO_SIDED|95.0|-2.48|4.3|||Cochran-Mantel-Haenszel|||Week 1, Day 7||4.30|-2.48|0.5976
72385556|NCT02833350|144278819|SUPERIORITY||Adjusted Difference|1.82||||0.3482|TWO_SIDED|95.0|-1.98|5.62|||Cochran-Mantel-Haenszel|||Week 1, Day 7||5.62|-1.98|0.3482
72385557|NCT02833350|144278819|SUPERIORITY||Adjusted Difference|-0.4||||0.8979|TWO_SIDED|95.0|-6.51|5.71|||Cochran-Mantel-Haenszel|||Week 2, Day 14||5.71|-6.51|0.8979
72385558|NCT02833350|144278819|SUPERIORITY||Adjusted Difference|-0.91||||0.5976|TWO_SIDED|95.0|-4.3|2.48|||Cochran-Mantel-Haenszel|||Week 2, Day 14||2.48|-4.30|0.5976
72385559|NCT02833350|144278819|SUPERIORITY||Adjusted Difference|0.91||||0.6546|TWO_SIDED|95.0|-3.07|4.89|||Cochran-Mantel-Haenszel|||Week 2, Day 14||4.89|-3.07|0.6546
72385560|NCT02833350|144278819|SUPERIORITY||Adjusted Difference|-0.8||||0.7988|TWO_SIDED|95.0|-6.95|5.35|||Cochran-Mantel-Haenszel|||Week 4 Day 28||5.35|-6.95|0.7988
72385561|NCT02833350|144278819|SUPERIORITY||Adjusted Difference|0.01||||0.9975|TWO_SIDED|95.0|-4.35|4.36|||Cochran-Mantel-Haenszel|||Week 4 Day 28||4.36|-4.35|0.9975
72385562|NCT02833350|144278819|SUPERIORITY||Adjusted Difference|4.55||||0.1185|TWO_SIDED|95.0|-1.16|10.25|||Cochran-Mantel-Haenszel|||Week 4, Day 28||10.25|-1.16|0.1185
72385563|NCT02833350|144278819|SUPERIORITY||Adjusted Difference|-2.4||||0.4765|TWO_SIDED|95.0|-9.01|4.21|||Cochran-Mantel-Haenszel|||Week 8, Day 56||4.21|-9.01|0.4765
72385564|NCT02833350|144278819|SUPERIORITY||Adjusted Difference|4.61||||0.1655|TWO_SIDED|95.0|-1.9|11.12|||Cochran-Mantel-Haenszel|||Week 8, Day 56||11.12|-1.90|0.1655
72385565|NCT02833350|144278819|SUPERIORITY||Adjusted Difference|8.18||||0.0234|TWO_SIDED|95.0|1.11|15.26|||Cochran-Mantel-Haenszel|||Week 8, Day 56||15.26|1.11|0.0234
72385566|NCT02833350|144278819|SUPERIORITY||Adjusted Difference|3.2||||0.549|TWO_SIDED|95.0|-7.27|13.67|||Cochran-Mantel-Haenszel|||Week 12, Day 84||13.67|-7.27|0.5490
72385567|NCT02833350|144278819|SUPERIORITY||Mean Difference (Net)|15.62||||0.0003|TWO_SIDED|95.0|7.22|24.03|||Cochran-Mantel-Haenszel|||Week 12, Day 84||24.03|7.22|0.0003
72385568|NCT02833350|144278819|SUPERIORITY||Adjusted Difference|10.91||||0.0044|TWO_SIDED|95.0|3.39|18.43|||Cochran-Mantel-Haenszel|||Week 12, Day 84||18.43|3.39|0.0044
72385569|NCT02833350|144278819|SUPERIORITY||Adjusted Difference|2.05||||0.6588|TWO_SIDED|95.0|-7.07|11.18|||Cochran-Mantel-Haenszel|||Week 1, Day 7||11.18|-7.07|0.6588
72385570|NCT02833350|144278819|SUPERIORITY||Adjusted Difference|0.68||||0.8853|TWO_SIDED|95.0|-8.62|9.99|||Cochran-Mantel-Haenszel|||Week 2, Day 14||9.99|-8.62|0.8853
72385571|NCT02833350|144278819|SUPERIORITY||Adjusted Difference|2.05||||0.6564|TWO_SIDED|95.0|-7.0|11.11|||Cochran-Mantel-Haenszel|||Week 4, Day 28||11.11|-7.00|0.6564
72385572|NCT02833350|144278819|SUPERIORITY||Adjusted Difference|0.68||||0.8853|TWO_SIDED|95.0|-8.62|9.99|||Cochran-Mantel-Haenszel|||Week 8, Day 56||9.99|-8.62|0.8853
72385573|NCT02833350|144278819|SUPERIORITY||Adjusted Difference|11.64||||0.0584|TWO_SIDED|95.0|-0.41|23.7|||Cochran-Mantel-Haenszel|||Week 12, Day 84||23.70|-0.41|0.0584
72385574|NCT02833350|144278820|SUPERIORITY||Adjusted Difference|0.0||||1|TWO_SIDED|95.0|-6.06|6.06|||Cochran-Mantel-Haenszel|||Week 1, Day 7||6.06|-6.06|1.0000
72385575|NCT02833350|144278820|SUPERIORITY||Adjusted Difference|0.0||||1|TWO_SIDED|95.0|-2.92|2.92|||Cochran-Mantel-Haenszel|||Week 1, Day 7||2.92|-2.92|1.0000
72385576|NCT02833350|144278820|SUPERIORITY||Adjusted Difference|0.0||||1|TWO_SIDED|95.0|-2.91|2.91|||Cochran-Mantel-Haenszel|||Week 1, Day 7||2.91|-2.91|1.0000
72385577|NCT02833350|144278820|SUPERIORITY||Adjusted Difference|0.0||||1|TWO_SIDED|95.0|-6.06|6.06|||Cochran-Mantel-Haenszel|||Week 2, Day 14||6.06|-6.06|1.0000
72385578|NCT02833350|144278820|SUPERIORITY||Adjusted Difference|0.0||||1|TWO_SIDED|95.0|-2.92|2.92|||Cochran-Mantel-Haenszel|||Week 2, Day 14||2.92|-2.92|1.0000
72385579|NCT02833350|144278820|SUPERIORITY||Adjusted Difference|0.91||||0.5976|TWO_SIDED|95.0|-2.47|4.28|||Cochran-Mantel-Haenszel|||Week 2, Day 14||4.28|-2.47|0.5976
72385580|NCT02833350|144278820|SUPERIORITY||Adjusted Difference|-0.4||||0.8979|TWO_SIDED|95.0|-6.51|5.71|||Cochran-Mantel-Haenszel|||Week 4, Day 28||5.71|-6.51|0.8979
72558707|NCT00521586|144647387|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.95|||||TWO_SIDED|95.0|0.81|1.11||||||Serotype 14: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution.||1.11|0.81|
72558708|NCT00521586|144647387|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.92|||||TWO_SIDED|95.0|0.79|1.06||||||Serotype 18C: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution.||1.06|0.79|
72438035|NCT03478696|144388866|SUPERIORITY||Mean Difference (Net)|0.051|STANDARD_ERROR_OF_MEAN|0.0157||0.001|TWO_SIDED|95.0|0.021|0.082||Only if superiority is achieved on the primary study endpoint, then inferences can be made on change from Baseline in trough FEV1 on Day 85 using p-values.|Mixed model repeated measures||Day 85|||0.082|0.021|0.001
72438036|NCT03478696|144388867|SUPERIORITY||Mean Difference (Net)|0.004|STANDARD_ERROR_OF_MEAN|0.0098||0.702|TWO_SIDED|95.0|-0.016|0.023||Only if superiority is achieved on the primary study endpoint, then inferences can be made on weighted mean change from Baseline in FEV1 over 0-24 hours on Day 1 using p-values.|Mixed model repeated measures||The treatment effect to be estimated was hypothetical effect if all participants stayed on their randomized study treatment. Only on treatment data was included in analysis.|||0.023|-0.016|0.702
72438037|NCT03478696|144388868|SUPERIORITY||Mean Difference (Net)|0.016|STANDARD_ERROR_OF_MEAN|0.0141||0.244|TWO_SIDED|95.0|-0.011|0.044||The analysis was performed using mixed model repeated measures analysis, which included covariates of Baseline FEV1, geographical region, treatment, visit, visit by treatment and visit by Baseline interaction.|Mixed model repeated measures||The treatment effect to be estimated was hypothetical effect if all participants stayed on their randomized study treatment. Only on treatment data was included in analysis.|||0.044|-0.011|0.244
72438038|NCT03615924|144388869|SUPERIORITY||Incidence rate ratio|1.06||||0.7597|TWO_SIDED|95.0|0.75|1.5|||Negative binomial model|||Incidence rates, incidence rate ratios, and p-values are from a negative binomial model analysis, with treatment group and baseline hydroxyurea use included in the model as covariates.||1.50|0.75|0.7597
72438039|NCT03615924|144388870|SUPERIORITY||Incidence rate ratio|1.02||||0.9037|TWO_SIDED|95.0|0.72|1.45|||Negative binomial model|||Incidence rates, incidence rate ratios, and p-values are from a negative binomial model analysis, with treatment group and baseline hydroxyurea use included in the model as covariates.||1.45|0.72|0.9037
72438040|NCT03615924|144388871|SUPERIORITY||Incidence rate ratio|0.76||||0.7136|TWO_SIDED|95.0|0.17|3.3|||Negative binomial model|||Incidence rates, incidence rate ratios, and p-values are from a negative binomial model analysis, with treatment group and baseline hydroxyurea use included in the model as covariates.||3.30|0.17|0.7136
72438041|NCT03615924|144388872|SUPERIORITY||Incidence rate ratio|0.84||||0.497|TWO_SIDED|95.0|0.5|1.4|||Negative binomial model|||Incidence rates, incidence rate ratios, and p-values are from a negative binomial model analysis, with treatment group and baseline hydroxyurea use included in the model as covariates.||1.40|0.50|0.4970
72438042|NCT03615924|144388873|SUPERIORITY||Incidence rate ratio|1.43||||0.1636|TWO_SIDED|95.0|0.87|2.36|||Negative binomial model|||Incidence rates, incidence rate ratios, and p-values are from a negative binomial model analysis, with treatment group and baseline hydroxyurea use included in the model as covariates.||2.36|0.87|0.1636
72438043|NCT03615924|144388874|SUPERIORITY||Incidence rate ratio|1.68||||0.2011|TWO_SIDED|95.0|0.76|3.75|||Negative binomial model|||Incidence rates, incidence rate ratios, and p-values are from a negative binomial model analysis, with treatment group and baseline hydroxyurea use included in the model as covariates.||3.75|0.76|0.2011
72558709|NCT00521586|144647387|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.93|||||TWO_SIDED|95.0|0.8|1.08||||||Serotype 19A: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution.||1.08|0.80|
72438044|NCT03615924|144388876|SUPERIORITY||Incidence rate ratio|0.0||||0.994|TWO_SIDED|95.0|0.0||Upper limit of confidence interval was not calculable due to 0 events in Ticagrelor 15/30/45 mg bd reporting group.||Negative binomial model|||Incidence rates, incidence rate ratios, and p-values are from a negative binomial model analysis, with treatment group and baseline hydroxyurea use included in the model as covariates.|||0.00|0.9940
72438045|NCT03615924|144388877|SUPERIORITY||Incidence rate ratio|0.77||||0.4822|TWO_SIDED|95.0|0.38|1.58|||Negative binomial model|||Incidence rates, incidence rate ratios, and p-values are from a negative binomial model analysis, with treatment group and baseline hydroxyurea use included in the model as covariates.||1.58|0.38|0.4822
72438046|NCT01667796|144388912|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED||||||univariate generalized estimating equati|||||||0.001
72438047|NCT01667796|144388912|SUPERIORITY_OR_OTHER|||||||0.008|TWO_SIDED|||||Adjusted for adherence, body mass index, and oral contraceptive use|Generalized estimating equation|||||||0.008
72438048|NCT01350804|144388917|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.79||||0.0458|TWO_SIDED|95.0|1.0|3.2|||Regression, Logistic|||||3.2|1.0|0.0458
72438049|NCT01350804|144388917|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.02||||0.0152|TWO_SIDED|95.0|1.1|3.5|||Regression, Logistic|||||3.5|1.1|0.0152
72438050|NCT01359371|144388942|SUPERIORITY||||||<|0.01|||||||Fisher Exact|||Bivariate relationships between a patient's participation in the program and smoking status were calculated.||||<.01
72438051|NCT01359371|144388943|OTHER|T-tests, chi squares and Fishers exact tests were used to compare groups.|||||<|0.05||||||This was just a sample description, so there was not adjustment for multiple comparisons.|Chi-squared||||T-tests, chi squares and Fishers exact tests were used to compare groups.|||<.05
72438052|NCT01359371|144388943|OTHER||||||<|0.05|||||||Chi-squared|||T-tests, chi squares and Fishers exact tests were used to compare groups.||||<.05
72438053|NCT05328297|144388961|SUPERIORITY||Least Square Mean difference|-0.3|STANDARD_ERROR_OF_MEAN|1.96|=|0.438|TWO_SIDED|80.0|-2.84|2.23|||Mixed Model for Repeated Measures (MMRM)|||||2.23|-2.84|=0.438
72438054|NCT02544152|144388994|OTHER||||||=|0.987|||||||Cochran-Mantel-Haenszel|||P-value is from a Cochran-Mantel-Haenszel (CMH) test stratified by sex and baseline stool consistency||||=0.9870
72438055|NCT00186186|144389036|SUPERIORITY_OR_OTHER||||||<|1e-05|||||||Wilcoxon (Mann-Whitney)|||||||<0.00001
72558710|NCT00521586|144647387|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.93|||||TWO_SIDED|95.0|0.77|1.12||||||Serotype 19F: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution.||1.12|0.77|
72558711|NCT00521586|144647387|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.9|||||TWO_SIDED|95.0|0.74|1.09||||||Serotype 23F: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution.||1.09|0.74|
72618834|NCT06097273|144768198|SUPERIORITY|The superiority in SCR in the Cohort A1 group compared with that of Cohort A2 group was demonstrated if the lower bound of the 95% CI of the SCR difference was \>0%.|Percentage Difference|4.5|||||TWO_SIDED|95.0|1.9|7.2||||||Percentage Difference (Cohort A1 vs Cohort A2) for Victoria-lineage Antibody||7.2|1.9|
72438056|NCT00186186|144389037|SUPERIORITY_OR_OTHER||Percentage|54.0|||||TWO_SIDED|||||||||||||
72438057|NCT01113931|144389046|SUPERIORITY_OR_OTHER||Difference in Percent Cure Rates|0.3|||||TWO_SIDED|95.0|-4.6|5.1||||||The planned sample size of 480 randomized subjects ensured that approximately 200 subjects per group were included in the primary efficacy analyses. The 20% rate of exclusion was to account for subjects who had a negative test for urogenital C. trachomatis at the Baseline visit.||5.1|-4.6|
72438058|NCT01113931|144389049|SUPERIORITY_OR_OTHER||Difference in Percent Cure Rates|0.2|||||TWO_SIDED|95.0|-4.6|5.1||||||The planned sample size of 480 randomized subjects ensured that approximately 200 subjects per group were included in the primary efficacy analyses. The 20% rate of exclusion was to account for subjects who had a negative test for urogenital C. trachomatis at the Baseline visit.||5.1|-4.6|
72438059|NCT03959241|144389058|SUPERIORITY||Hazard Ratio (HR)|0.641||||0.001|TWO_SIDED|95.0|0.492|0.835||Statistical significance was determined using a pre-specified threshold of 0.05|Regression, Cox|||This is the result of the Cox proportional hazards analysis. The null hypothesis is that there is no difference of GRFS hazard ratio between treatment groups after adjustment for age group, donor type and HLA Matching Score, disease risk index, Planned RIC Conditioning Regimen, and Planned post-transplant maintenance therapies.||0.835|0.492|0.001
72438060|NCT03959241|144389059|SUPERIORITY|||||||0.995||||||Statistical significance was determined using a pre-specified threshold of 0.05.|Gray's test for cumulative Incidence|||This is the unadjusted analysis. The null hypothesis is that there is no difference of grade II-IV acute GVHD post-transplantation between the treatment groups.||||0.995
72438061|NCT03959241|144389059|SUPERIORITY|||||||0.001||||||Statistical significance was determined using a pre-specified threshold of 0.05|Gray's test for cumulative Incidence|||This is the unadjusted analysis. The null hypothesis is that there is no difference of grade III-IV acute GVHD post-transplantation between the treatment groups||||0.001
72438062|NCT03959241|144389059|SUPERIORITY||Hazard Ratio (HR)|0.98||||0.879|TWO_SIDED|95.0|0.758|1.267||Statistical significance was determined using a pre-specified threshold of 0.05|Regression, Cox|||This is the result of the Cox proportional hazards analysis. The null hypothesis is that there is no difference of grade II-IV acute GVHD post-transplantation between the treatment groups using a Cox regression model for the cause-specific hazard of aGVHD||1.267|0.758|0.879
72438063|NCT03959241|144389059|SUPERIORITY||Hazard Ratio (HR)|0.386||||0.001|TWO_SIDED|95.0|0.215|0.691||Statistical significance was determined using a pre-specified threshold of 0.05|Regression, Cox|||This is the result of the Cox proportional hazards analysis. The null hypothesis is that there is no difference of grade III-IV aGVHD hazard ratio between treatment groups after adjustment for age group, donor type and HLA Matching Score, disease risk index, Planned RIC Conditioning Regimen, and Planned post-transplant maintenance therapies.||0.691|0.215|0.001
72438064|NCT03959241|144389063|SUPERIORITY|||||||0.005||||||Statistical significance was determined using a pre-specified threshold of 0.05|Gray's test for cumulative Incidence|||This is the unadjusted analysis. The null hypothesis is that there is no difference of chronic GVHD post-transplantation between the treatment groups||||0.005
72438065|NCT03959241|144389063|SUPERIORITY||Hazard Ratio (HR)|0.556||||0.002|TWO_SIDED|95.0|0.381|0.813||Statistical significance was determined using a pre-specified threshold of 0.05|Regression, Cox|||This is the result of the Cox proportional hazards analysis. The null hypothesis is that there is no difference of the chronic GVHD hazard ratio between treatment groups after adjustment for age group, donor type and HLA Matching Score, disease risk index, Planned RIC Conditioning Regimen, and Planned post-transplant maintenance therapies||0.813|0.381|0.002
72438066|NCT03959241|144389066|SUPERIORITY|||||||0.038||||||Statistical significance was determined using a pre-specified threshold of 0.05|Chi-squared|||The null hypothesis is that there is no difference of Immunosuppression-Free Survival between the treatment groups||||0.038
72438067|NCT03959241|144389067|SUPERIORITY|||||||0.032||||||Statistical significance was determined using a pre-specified threshold of 0.05|Gray's test for cumulative Incidence|||The null hypothesis is that there is no difference of Neutrophil Recovery between the treatment groups||||0.032
72438068|NCT03959241|144389068|SUPERIORITY||||||<|0.001||||||Statistical significance was determined using a pre-specified threshold of 0.05|Gray's test for cumulative Incidence|||The null hypothesis is that there is no difference of Platelet Recovery greater than or equal to 20,000/mm\^3 between the treatment groups||||<0.001
72438069|NCT03959241|144389068|SUPERIORITY||||||<|0.001||||||Statistical significance was determined using a pre-specified threshold of 0.05|Gray's test for cumulative Incidence|||The null hypothesis is that there is no difference of Platelet Recovery greater than or equal to 50,000/mm\^3 between the treatment groups||||<0.001
72438070|NCT03959241|144389069|SUPERIORITY||||||<|0.001||||||Statistical significance was determined using a pre-specified threshold of 0.05|Gray's test for cumulative Incidence|||The null hypothesis is that there is no difference of Lymphocyte Recovery between the treatment groups||||<0.001
72438071|NCT03959241|144389070|SUPERIORITY|||||||0.919||||||Statistical significance was determined using a pre-specified threshold of 0.05|Fisher Exact|||The null hypothesis is that there is no difference of Donor Cell Engraftment at Day 28 after transplantation between the treatment groups||||0.919
72438072|NCT03959241|144389070|SUPERIORITY|||||||0.198||||||Statistical significance was determined using a pre-specified threshold of 0.05.|Fisher Exact|||The null hypothesis is that there is no difference of Donor Cell Engraftment at Day 100 after transplantation between the treatment groups||||0.198
72385581|NCT02833350|144278820|SUPERIORITY||Adjusted Difference|-0.91||||0.5976|TWO_SIDED|95.0|-4.3|2.48|||Cochran-Mantel-Haenszel|||Week 4 Day 28||2.48|-4.30|0.5976
72385582|NCT02833350|144278820|SUPERIORITY||Adjusted Difference|0.91||||0.6669|TWO_SIDED|95.0|-3.23|5.05|||Cochran-Mantel-Haenszel|||Week 4, Day 28||5.05|-3.23|0.6669
72385583|NCT02833350|144278820|SUPERIORITY||Adjusted Difference|-1.6||||0.6309|TWO_SIDED|95.0|-8.13|4.93|||Cochran-Mantel-Haenszel|||Week 8, Day 56||4.93|-8.13|0.6309
72385584|NCT02833350|144278820|SUPERIORITY||Adjusted Difference|1.83||||0.4473|TWO_SIDED|95.0|-2.9|6.56|||Cochran-Mantel-Haenszel|||Week 8, Day 56||6.56|-2.90|0.4473
72385585|NCT02833350|144278820|SUPERIORITY||Adjusted Difference|2.73||||0.3021|TWO_SIDED|95.0|-2.45|7.91|||Cochran-Mantel-Haenszel|||Week 8, Day 56||7.91|-2.45|0.3021
72385586|NCT02833350|144278820|SUPERIORITY||Adjusted Difference|-1.6||||0.7134|TWO_SIDED|95.0|-10.14|6.94|||Cochran-Mantel-Haenszel|||Week 12, Day 84||6.94|-10.14|0.7134
72385587|NCT02833350|144278820|SUPERIORITY||Adjusted Difference|3.7||||0.2635|TWO_SIDED|95.0|-2.79|10.19|||Cochran-Mantel-Haenszel|||Week 12, Day 84||10.19|-2.79|0.2635
72385588|NCT02833350|144278820|SUPERIORITY||Adjusted Difference|4.55||||0.1749|TWO_SIDED|95.0|-2.02|11.11|||Cochran-Mantel-Haenszel|||Week 12, Day 84||11.11|-2.02|0.1749
72385589|NCT02833350|144278820|SUPERIORITY||Adjusted Difference|2.05||||0.6588|TWO_SIDED|95.0|-7.07|11.18|||Cochran-Mantel-Haenszel|||Week 1, Day 7||11.18|-7.07|0.6588
72385590|NCT02833350|144278820|SUPERIORITY||Adjusted Difference|0.0||||1|TWO_SIDED|95.0|-8.31|8.31|||Cochran-Mantel-Haenszel|||Week 2 Day 14||8.31|-8.31|1.0000
72438073|NCT03959241|144389071|SUPERIORITY|||||||0.67||||||Statistical significance was determined using a pre-specified threshold of 0.05.|Wilcoxon (Mann-Whitney)|||The null hypothesis is that there is no difference of quantitative donor chimerism at Day 28 after transplantation between the treatment groups||||0.670
72385591|NCT02833350|144278820|SUPERIORITY||Adjusted Difference|0.0||||1|TWO_SIDED|95.0|-8.31|8.31|||Cochran-Mantel-Haenszel|||Week 4, Day 28||8.31|-8.31|1.0000
72385592|NCT02833350|144278820|SUPERIORITY||Adjusted Difference|0.0||||1|TWO_SIDED|95.0|-8.31|8.31|||Cochran-Mantel-Haenszel|||Week 8, Day 56||8.31|-8.31|1.0000
72385593|NCT02833350|144278820|SUPERIORITY||Adjusted Difference|1.37||||0.7848|TWO_SIDED|95.0|-8.46|11.2|||Cochran-Mantel-Haenszel|||Week 12, Day 84||11.20|-8.46|0.7848
72385594|NCT02833350|144278821|SUPERIORITY||Adjusted Difference|0.0||||1|TWO_SIDED|95.0|-6.28|6.28|||Cochran-Mantel-Haenszel|||Week 1, Day 7||6.28|-6.28|1.0000
72385595|NCT02833350|144278821|SUPERIORITY||Adjusted Difference|0.93||||0.5941|TWO_SIDED|95.0|-2.5|4.37|||Cochran-Mantel-Haenszel|||Week 1, Day 7||4.37|-2.50|0.5941
72438074|NCT03959241|144389071|SUPERIORITY|||||||0.607||||||Statistical significance was determined using a pre-specified threshold of 0.05|Wilcoxon (Mann-Whitney)|||The null hypothesis is that there is no difference of quantitative donor chimerism at Day 100 after transplantation between the treatment groups||||0.607
72385596|NCT02833350|144278821|SUPERIORITY||Adjusted Difference|0.0||||1|TWO_SIDED|95.0|-2.93|2.93|||Cochran-Mantel-Haenszel|||Week 1, Day 7||2.93|-2.93|1.0000
72385597|NCT02833350|144278821|SUPERIORITY||Adjusted Difference|0.0||||1|TWO_SIDED|95.0|-6.17|6.17|||Cochran-Mantel-Haenszel|||Week 2, Day 14||6.17|-6.17|1.0000
72385598|NCT02833350|144278821|SUPERIORITY||Adjusted Difference|0.0||||1|TWO_SIDED|95.0|-2.95|2.95|||Cochran-Mantel-Haenszel|||Week 2, Day 14||2.95|-2.95|1.0000
72385599|NCT02833350|144278821|SUPERIORITY||Adjusted Difference|0.0||||1|TWO_SIDED|95.0|-2.92|2.92|||Cochran-Mantel-Haenszel|||Week 2, Day 14||2.92|-2.92|1.0000
72438075|NCT03959241|144389072|SUPERIORITY|||||||0.906||||||Statistical significance was determined using a pre-specified threshold of 0.05|Gray's test for cumulative Incidence|||This is the unadjusted analysis. The null hypothesis is that there is no difference of Disease Relapse between the treatment groups||||0.906
72385600|NCT02833350|144278821|SUPERIORITY||Adjusted Difference|-0.43||||0.8929|TWO_SIDED|95.0|-6.62|5.77|||Cochran-Mantel-Haenszel|||Week 4, Day 28||5.77|-6.62|0.8929
72385601|NCT02833350|144278821|SUPERIORITY||Adjusted Difference|-0.13||||0.9424|TWO_SIDED|95.0|-3.78|3.51|||Cochran-Mantel-Haenszel|||Week 4, Day 28||3.51|-3.78|0.9424
72385602|NCT02833350|144278821|SUPERIORITY||Adjusted Difference|-0.94||||0.5927|TWO_SIDED|95.0|-4.4|2.51|||Cochran-Mantel-Haenszel|||Week 4, Day 28||2.51|-4.40|0.5927
72385603|NCT02833350|144278821|SUPERIORITY||Adjusted Difference|-0.46||||0.8788|TWO_SIDED|95.0|-6.31|5.4|||Cochran-Mantel-Haenszel|||Week 8, Day 56||5.40|-6.31|0.8788
72385604|NCT02833350|144278821|SUPERIORITY||Adjusted Difference|0.87||||0.6876|TWO_SIDED|95.0|-3.36|5.09|||Cochran-Mantel-Haenszel|||Week 8 Day 56||5.09|-3.36|0.6876
72385605|NCT02833350|144278821|SUPERIORITY||Adjusted Difference|0.97||||0.6656|TWO_SIDED|95.0|-3.42|5.35|||Cochran-Mantel-Haenszel|||Week 8, Day 56||5.35|-3.42|0.6656
72385606|NCT02833350|144278821|SUPERIORITY||Adjusted Difference|-0.46||||0.8787|TWO_SIDED|95.0|-6.34|5.42|||Cochran-Mantel-Haenszel|||Week 12 Day 84||5.42|-6.34|0.8787
72385607|NCT02833350|144278821|SUPERIORITY||Adjusted Difference|0.74||||0.7101|TWO_SIDED|95.0|-3.17|4.66|||Cochran-Mantel-Haenszel|||Week 12, Day 84||4.66|-3.17|0.7101
72385608|NCT02833350|144278821|SUPERIORITY||Adjusted Difference|3.2||||0.2425|TWO_SIDED|95.0|-2.16|8.55|||Cochran-Mantel-Haenszel|||Week 12, Day 84||8.55|-2.16|0.2425
72385609|NCT02833350|144278821|SUPERIORITY||Adjusted Difference|0.0||||1|TWO_SIDED|95.0|-8.68|8.68|||Cochran-Mantel-Haenszel|||Week 1, Day 7||8.68|-8.68|1.0000
72385610|NCT02833350|144278821|SUPERIORITY||Adjusted Difference|0.0||||1|TWO_SIDED|95.0|-8.39|8.39|||Cochran-Mantel-Haenszel|||Week 2 Day 14||8.39|-8.39|1.0000
72385611|NCT02833350|144278821|SUPERIORITY||Adjusted Difference|2.03||||0.6658|TWO_SIDED|95.0|-7.17|11.22|||Cochran-Mantel-Haenszel|||Week 4, Day 28||11.22|-7.17|0.6658
72385612|NCT02833350|144278821|SUPERIORITY||Adjusted Difference|0.0||||1|TWO_SIDED|95.0|-8.77|8.77|||Cochran-Mantel-Haenszel|||Week 8, Day 56||8.77|-8.77|1.0000
72385613|NCT02833350|144278821|SUPERIORITY||Adjusted Difference|6.57||||0.2457|TWO_SIDED|95.0|-4.52|17.66|||Cochran-Mantel-Haenszel|||Week 12, Day 84||17.66|-4.52|0.2457
72385614|NCT02833350|144278822|SUPERIORITY||Adjusted Difference|-2.36||||0.496|TWO_SIDED|95.0|-6.73|2.02|||Cochran-Mantel-Haenszel|||Week 1, Day 7||2.02|-6.73|0.4960
72385615|NCT02833350|144278822|SUPERIORITY||Adjusted Difference|-2.18||||0.2736|TWO_SIDED|95.0|-5.34|0.98|||Cochran-Mantel-Haenszel|||Week 1, Day 7||0.98|-5.34|0.2736
72385616|NCT02833350|144278822|SUPERIORITY||Adjusted Difference|-3.08||||0.0608|TWO_SIDED|95.0|-6.26|0.1|||Cochran-Mantel-Haenszel|||Week 1, Day 7||0.10|-6.26|0.0608
72438076|NCT03959241|144389072|SUPERIORITY||Hazard Ratio (HR)|0.985||||0.947|TWO_SIDED|95.0|0.641|1.515||Statistical significance was determined using a pre-specified threshold of 0.05|Regression, Cox|||This is the result of the Cox proportional hazards analysis. The null hypothesis is that there is no difference of Disease Relapse hazard ratio between treatment groups after adjustment for age group, donor type and HLA Matching Score, disease risk index, Planned RIC Conditioning Regimen, and Planned post-transplant maintenance therapies||1.515|0.641|0.947
72438077|NCT03959241|144389073|SUPERIORITY|||||||0.167||||||Statistical significance was determined using a pre-specified threshold of 0.05|Gray's test for cumulative Incidence|||This is the unadjusted analysis. The null hypothesis is that there is no difference of Treatment-related Mortality between the treatment groups||||0.167
72558712|NCT03234907|144647406|SUPERIORITY||Risk Difference (RD)|-5.2|||=|0.347|TWO_SIDED|95.0|-17.2|6.8||P-value was based on CHW test, based on weighted CMH chi-square test, with stratification according to: (1)previous failure of TNF-α antagonist therapy/concomitant use of immunomodulators(Yes/No);(2)concomitant use of oral corticosteroids(Yes/No).|Cui-Hung-Wang (CHW) test||Mantel-Haenszel estimate of the treatment difference and its variance was used to calculate the 95% confidence interval for the treatment difference. Adjustment to the stratification factors was implemented.|||6.8|-17.2|=0.347
72618835|NCT06097273|144768198|NON_INFERIORITY|The noninferiority in SCR in the Cohort A1 group compared with that of Cohort A2 group was demonstrated if the lower bound of the 97.5% CI of the SCR difference was \>-10%.|Percentage Difference|4.5|||||TWO_SIDED|95.0|1.5|7.5||||||Percentage Difference (Cohort A1 vs Cohort A2) for Victoria-lineage Antibody||7.5|1.5|
72385617|NCT02833350|144278822|SUPERIORITY||Adjusted Difference|-1.25||||0.9237|TWO_SIDED|95.0|-6.02|3.52|||Cochran-Mantel-Haenszel|||Week 2, Day 14||3.52|-6.02|0.9237
72385618|NCT02833350|144278822|SUPERIORITY||Adjusted Difference|-3.14||||0.0893|TWO_SIDED|95.0|-6.6|0.33|||Cochran-Mantel-Haenszel|||Week 2, Day 14||0.33|-6.60|0.0893
72385619|NCT02833350|144278822|SUPERIORITY||Adjusted Difference|-4.07||||0.0138|TWO_SIDED|95.0|-7.51|-0.63|||Cochran-Mantel-Haenszel|||Week 2, Day 14||-0.63|-7.51|0.0138
72385620|NCT02833350|144278822|SUPERIORITY||Adjusted Difference|-3.22||||0.3358|TWO_SIDED|95.0|-8.24|1.8|||Cochran-Mantel-Haenszel|||Week 4, Day 28||1.80|-8.24|0.3358
72385621|NCT02833350|144278822|SUPERIORITY||Adjusted Difference|-4.57||||0.0078|TWO_SIDED|95.0|-8.2|-0.94|||Cochran-Mantel-Haenszel|||Week 4, Day 28||-0.94|-8.20|0.0078
72385622|NCT02833350|144278822|SUPERIORITY||Adjusted Difference|-4.68||||0.0059|TWO_SIDED|95.0|-8.3|-1.06|||Cochran-Mantel-Haenszel|||Week 4, Day 28||-1.06|-8.30|0.0059
72385623|NCT02833350|144278822|SUPERIORITY||Adjusted Difference|-2.29||||0.6503|TWO_SIDED|95.0|-7.39|2.8|||Cochran-Mantel-Haenszel|||Week 8, Day 56||2.80|-7.39|0.6503
72558713|NCT03234907|144647407|SUPERIORITY||Risk Difference (RD)|-2.7|||=|0.531|TWO_SIDED|95.0|-11.5|6.0||P-value based on Cochran-Mantel-Haenszel, weighted CMH chi-square test, with stratification according to:(1)previous failure of TNF-α antagonist therapy/concomitant use of immunomodulators(Yes/No);(2)concomitant use of oral corticosteroids(Yes/No).|Cochran-Mantel-Haenszel||Mantel-Haenszel estimate of the treatment difference and its variance was used to calculate the 95% confidence interval for the treatment difference. Adjustment to the stratification factors was implemented.|||6.0|-11.5|=0.531
72618836|NCT06097273|144768198|SUPERIORITY|The superiority in SCR in the Cohort A1 group compared with that of Cohort A2 group was demonstrated if the lower bound of the 95% CI of the SCR difference was \>0%.|Percentage Difference|-1.4|||||TWO_SIDED|95.0|-3.3|0.4||||||Percentage Difference (Cohort A1 vs Cohort A2) for Yamagata-lineage Antibody||0.4|-3.3|
72385624|NCT02833350|144278822|SUPERIORITY||Adjusted Difference|-3.12||||0.1282|TWO_SIDED|95.0|-6.84|0.59|||Cochran-Mantel-Haenszel|||Week 8, Day 56||0.59|-6.84|0.1282
72385625|NCT02833350|144278822|SUPERIORITY||Adjusted Difference|-2.94||||0.1675|TWO_SIDED|95.0|-6.65|0.78|||Cochran-Mantel-Haenszel|||Week 8, Day 56||0.78|-6.65|0.1675
72385626|NCT02833350|144278822|SUPERIORITY||Adjusted Difference|-2.94||||0.422|TWO_SIDED|95.0|-7.96|2.09|||Cochran-Mantel-Haenszel|||Week 12, Day 84||2.09|-7.96|0.4220
72385627|NCT02833350|144278822|SUPERIORITY||Adjusted Difference|-5.1||||0.0027|TWO_SIDED|95.0|-8.77|-1.42|||Cochran-Mantel-Haenszel|||Week 12, Day 84||-1.42|-8.77|0.0027
72385628|NCT02833350|144278822|SUPERIORITY||Adjusted Difference|-5.47||||0.0011|TWO_SIDED|95.0|-9.15|-1.78|||Cochran-Mantel-Haenszel|||Week 12, Day 84||-1.78|-9.15|0.0011
72385629|NCT02833350|144278822|SUPERIORITY||Adjusted Difference|3.21||||0.0455|TWO_SIDED|95.0|0.05|6.37|||Cochran-Mantel-Haenszel|||Week 1, Day 7||6.37|0.05|0.0455
72385630|NCT02833350|144278822|SUPERIORITY||Adjusted Difference|2.31||||0.2309|TWO_SIDED|95.0|-0.87|5.48|||Cochran-Mantel-Haenszel|||Week 1, Day 7||5.48|-0.87|0.2309
72385631|NCT02833350|144278822|SUPERIORITY||Adjusted Difference|3.27||||0.0698|TWO_SIDED|95.0|-0.18|6.72|||Cochran-Mantel-Haenszel|||Week 2, Day 14||6.72|-0.18|0.0698
72385632|NCT02833350|144278822|SUPERIORITY||Adjusted Difference|2.33||||0.2851|TWO_SIDED|95.0|-1.09|5.76|||Cochran-Mantel-Haenszel|||Week 2, Day 14||5.76|-1.09|0.2851
72385633|NCT02833350|144278822|SUPERIORITY||Adjusted Difference|4.29||||0.0131|TWO_SIDED|95.0|0.69|7.9|||Cochran-Mantel-Haenszel|||Week 4, Day 28||7.90|0.69|0.0131
72385634|NCT02833350|144278822|SUPERIORITY||Adjusted Difference|4.18||||0.0161|TWO_SIDED|95.0|0.59|7.78|||Cochran-Mantel-Haenszel|||Week 4, Day 28||7.78|0.59|0.0161
72385635|NCT02833350|144278822|SUPERIORITY||Adjusted Difference|3.85||||0.036|TWO_SIDED|95.0|0.18|7.51|||Cochran-Mantel-Haenszel|||Week 8, Day 56||7.51|0.18|0.0360
72385636|NCT02833350|144278822|SUPERIORITY||Adjusted Difference|4.04||||0.0252|TWO_SIDED|95.0|0.37|7.7|||Cochran-Mantel-Haenszel|||Week 8, Day 56||7.70|0.37|0.0252
72385637|NCT02833350|144278822|SUPERIORITY||Adjusted Difference|1.03||||0.9032|TWO_SIDED|95.0|-2.59|4.66|||Cochran-Mantel-Haenszel|||Week 12, Day 84||4.66|-2.59|0.9032
72385638|NCT02833350|144278822|SUPERIORITY||Adjusted Difference|0.66||||0.9791|TWO_SIDED|95.0|-2.97|4.3|||Cochran-Mantel-Haenszel|||Week 12, Day 84||4.30|-2.97|0.9791
72385639|NCT02833350|144278822|SUPERIORITY||Adjusted Difference|-3.22||||0.0927|TWO_SIDED|95.0|-6.98|0.54|||Cochran-Mantel-Haenszel|||Week 1, Day 7||0.54|-6.98|0.0927
72385640|NCT02833350|144278822|SUPERIORITY||Adjusted Difference|-2.12||||0.3202|TWO_SIDED|95.0|-6.33|2.09|||Cochran-Mantel-Haenszel|||Week 2, Day 14||2.09|-6.33|0.3202
72385641|NCT02833350|144278822|SUPERIORITY||Adjusted Difference|-4.2||||0.0476|TWO_SIDED|95.0|-8.36|-0.04|||Cochran-Mantel-Haenszel|||Week 4, Day 28||-0.04|-8.36|0.0476
72385642|NCT02833350|144278822|SUPERIORITY||Adjusted Difference|-9.93|||<|0.0001|TWO_SIDED|95.0|-14.31|-5.55|||Cochran-Mantel-Haenszel|||Week 8, Day 54||-5.55|-14.31|<0.0001
72558714|NCT00642993|144647408|SUPERIORITY_OR_OTHER||Difference in means|0.41||||0.187|TWO_SIDED|95.0|-0.2|1.03|||ANOVA|Mean and standard error are least squares means and corresponding standard errors based on an ANOVA model with main effects for treatment.||||1.03|-0.20|0.187
72618837|NCT06097273|144768198|NON_INFERIORITY|The noninferiority in SCR in the Cohort A1 group compared with that of Cohort A2 group was demonstrated if the lower bound of the 97.5% CI of the SCR difference was \>-10%.|Percentage Difference|-1.4|||||TWO_SIDED|97.5|-3.6|0.7||||||Percentage Difference (Cohort A1 vs Cohort A2) for Yamagata-lineage Antibody||0.7|-3.6|
72385643|NCT02833350|144278822|SUPERIORITY||Adjusted Difference|-8.23||||0.0003|TWO_SIDED|95.0|-12.56|-3.9|||Cochran-Mantel-Haenszel|||Week 12, Day 84||-3.90|-12.56|0.0003
72385644|NCT02833350|144278823|SUPERIORITY||Adjusted Difference|0.0||||1|TWO_SIDED|95.0|-6.06|6.06|||Cochran-Mantel-Haenszel|||Week 1, Day 7||6.06|-6.06|1.0000
72385645|NCT02833350|144278823|SUPERIORITY||Adjusted Difference|0.91||||0.5976|TWO_SIDED|95.0|-2.48|4.3|||Cochran-Mantel-Haenszel|||Week 1, Day 7||4.30|-2.48|0.5976
72385646|NCT02833350|144278823|SUPERIORITY||Adjusted Difference|0.91||||0.5976|TWO_SIDED|95.0|-2.47|4.28|||Cochran-Mantel-Haenszel|||Week 1, Day 7||4.28|-2.47|0.5976
72385647|NCT02833350|144278823|SUPERIORITY||Adjusted Difference|0.0||||1|TWO_SIDED|95.0|-6.06|6.06|||Cochran-Mantel-Haenszel|||Week 2, Day 14||6.06|-6.06|1.0000
72385648|NCT02833350|144278823|SUPERIORITY||Adjusted Difference|0.0||||1|TWO_SIDED|95.0|-2.92|2.92|||Cochran-Mantel-Haenszel|||Week 2, Day 14||2.92|-2.92|1.0000
72385649|NCT02833350|144278823|SUPERIORITY||Adjusted Difference|0.0||||1|TWO_SIDED|95.0|-2.91|2.91|||Cochran-Mantel-Haenszel|||Week 2, Day 14||2.91|-2.91|1.0000
72385650|NCT02833350|144278823|SUPERIORITY||Adjusted Difference|0.0||||1|TWO_SIDED|95.0|-6.06|6.06|||Cochran-Mantel-Haenszel|||Week 4, Day 28||6.06|-6.06|1.0000
72385651|NCT02833350|144278823|SUPERIORITY||Adjusted Difference|0.91||||0.5726|TWO_SIDED|95.0|-2.26|4.09|||Cochran-Mantel-Haenszel|||Week 4, Day 28||4.09|-2.26|0.5726
72438078|NCT03959241|144389073|SUPERIORITY||Hazard Ratio (HR)|0.675||||0.133|TWO_SIDED|95.0|0.404|1.127||Statistical significance was determined using a pre-specified threshold of 0.05|Regression, Cox|||This is the result of the Cox proportional hazards analysis. The null hypothesis is that there is no difference of Treatment-related Mortality hazard ratio between treatment groups after adjustment for age group, donor type and HLA Matching Score, disease risk index, Planned RIC Conditioning Regimen, and Planned post-transplant maintenance therapies||1.127|0.404|0.133
72438079|NCT03959241|144389077|SUPERIORITY|||||||0.018||||||Statistical significance was determined using a pre-specified threshold of 0.05|Gray's test for cumulative Incidence|||The null hypothesis is that there is no difference of Grade 2 and 3 infections between the treatment groups||||0.018
72438080|NCT03959241|144389078|SUPERIORITY|||||||0.825||||||Statistical significance was determined using a pre-specified threshold of 0.05|Gray's test for cumulative Incidence|||The null hypothesis is that there is no difference of CMV between the treatment groups||||0. 825
72438081|NCT03959241|144389079|SUPERIORITY|||||||0.351||||||Statistical significance was determined using a pre-specified threshold of 0.05|Log Rank|||This is the unadjusted analysis. The null hypothesis is that there is no difference of Disease-Free Survival between the treatment groups||||0.351
72438082|NCT03959241|144389079|SUPERIORITY||Hazard Ratio (HR)|0.847||||0.32|TWO_SIDED|95.0|0.61|1.176||Statistical significance was determined using a pre-specified threshold of 0.05|Regression, Cox|||This is the result of the Cox proportional hazards analysis. The null hypothesis is that there is no difference of Disease-Free Survival hazard ratio between treatment groups after adjustment for age group, donor type and HLA Matching Score, disease risk index, Planned RIC Conditioning Regimen, and Planned post-transplant maintenance therapies||1.176|0.610|0.320
72558715|NCT00642993|144647409|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.58||||0.14|TWO_SIDED|95.0|0.28|1.2|||Cochran-Mantel-Haenszel|The P-value is from the Cochran-Mantel-Haenszel Test adjusting for gender.||||1.20|0.28|0.140
72438083|NCT03959241|144389080|SUPERIORITY|||||||0.335||||||Statistical significance was determined using a pre-specified threshold of 0.05|Log Rank|||This is the unadjusted analysis. The null hypothesis is that there is no difference of Overall Survival between the treatment groups||||0.335
72495208|NCT02475655|144519397|SUPERIORITY||Mean Difference (Net)|-1.47||||0.15|TWO_SIDED|90.0|-3.17|0.23||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in classical monocytes (CD14+CD16-) expressing CX3CR1+ from Entry to Week 5.||0.23|-3.17|0.15
72558716|NCT00642993|144647410|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.55||||0.515|TWO_SIDED|95.0|0.24|9.93|||Cochran-Mantel-Haenszel|The p-value is from the Cochran-Mantel-Haenszel Test adjusting for gender.||||9.93|0.24|0.515
72558717|NCT00642993|144647411|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.28||||0.543|TWO_SIDED|95.0|-1.2|0.63|||ANOVA|Mean and standard error are least squares means and corresponding standard errors based on an ANOVA model with main effects for treatment.||||0.63|-1.20|0.543
72385652|NCT02833350|144278823|SUPERIORITY||Adjusted Difference|0.91||||0.5976|TWO_SIDED|95.0|-2.47|4.28|||Cochran-Mantel-Haenszel|||Week 4, Day 28||4.28|-2.47|0.5976
72385653|NCT02833350|144278823|SUPERIORITY||Adjusted Difference|0.0||||1|TWO_SIDED|95.0|-6.06|6.06|||Cochran-Mantel-Haenszel|||Week 8, Day 56||6.06|-6.06|1.0000
72385654|NCT02833350|144278823|SUPERIORITY||Adjusted Difference|2.74||||0.1446|TWO_SIDED|95.0|-0.94|6.42|||Cochran-Mantel-Haenszel|||Week 8, Day 56||6.42|-0.94|0.1446
72385655|NCT02833350|144278823|SUPERIORITY||Adjusted Difference|5.45||||0.0286|TWO_SIDED|95.0|0.57|10.34|||Cochran-Mantel-Haenszel|||Week 8, Day 56||10.34|0.57|0.0286
72385656|NCT02833350|144278823|SUPERIORITY||Adjusted Difference|-0.4||||0.8979|TWO_SIDED|95.0|-6.51|5.71|||Cochran-Mantel-Haenszel|||Week 12, Day 84||5.71|-6.51|0.8979
72385657|NCT02833350|144278823|SUPERIORITY||Adjusted Difference|4.57||||0.0708|TWO_SIDED|95.0|-0.39|9.52|||Cochran-Mantel-Haenszel|||Week 12, Day 84||9.52|-0.39|0.0708
72385658|NCT02833350|144278823|SUPERIORITY||Adjusted Difference|5.45||||0.0478|TWO_SIDED|95.0|0.05|10.86|||Cochran-Mantel-Haenszel|||Week 12, Day 84||10.86|0.05|0.0478
72385659|NCT02833350|144278823|SUPERIORITY||Adjusted Difference|0.0||||1|TWO_SIDED|95.0|-8.31|8.31|||Cochran-Mantel-Haenszel|||Week 1, Day 7||8.31|-8.31|1.0000
72385660|NCT02833350|144278823|SUPERIORITY||Adjusted Difference|0.0||||1|TWO_SIDED|95.0|-8.31|8.31|||Cochran-Mantel-Haenszel|||Week 2, Day 14||8.31|-8.31|1.0000
72438084|NCT03959241|144389080|SUPERIORITY||Hazard Ratio (HR)|0.797||||0.252|TWO_SIDED|95.0|0.541|1.175||Statistical significance was determined using a pre-specified threshold of 0.05|Regression, Cox|||This is the result of the Cox proportional hazards analysis. The null hypothesis is that there is no difference of the Overall Survival hazard ratio between treatment groups after adjustment for age group, donor type and HLA Matching Score, disease risk index, Planned RIC Conditioning Regimen, and Planned post-transplant maintenance therapies||1.175|0.541|0.252
72438085|NCT00346151|144389088|SUPERIORITY_OR_OTHER||Incidence Rate|60.0||||||95.0|15.0|95.0|||95% exact binomial CI of proportion|||Proportion of participant's cumulative incidence of acute rejection at 24 weeks with 95% exact binomial confidence interval. Local biopsy reads were used in determining primary endpoint.||95|15|
72438086|NCT00346151|144389089|SUPERIORITY_OR_OTHER||Incidence Rate|100.0||||||95.0|40.0|100.0|||95% exact binomial CI of proportion|||Proportion with 95% exact binomial confidence interval||100|40|
72438087|NCT00346151|144389090|SUPERIORITY_OR_OTHER||Incidence rate|80.0||||||95.0|28.0|99.0|||95% exact binomial CI of proportion|||Proportion with 95% exact binomial confidence interval||99|28|
72438088|NCT00346151|144389093|SUPERIORITY_OR_OTHER||Incidence Rate|100.0||||||95.0|40.0|100.0|||95% exact binomial CI of proportion|||Proportion with 95% exact binomial confidence interval||100|40|
72438089|NCT00346151|144389095|SUPERIORITY_OR_OTHER||Incidence Rate|0.0||||||95.0|0.0|52.2|||95% exact binomial CI of proportion|||Proportion with 95% exact binomial confidence interval||52.2|0|
72495209|NCT02475655|144519397|SUPERIORITY||Mean Difference (Net)|-1.62||||0.37|TWO_SIDED|90.0|-4.59|1.35||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in classical monocytes (CD14+CD16-) expressing CX3CR1+ from Entry to Week 12.||1.35|-4.59|0.37
72558718|NCT00642993|144647412|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.13||||0.231|TWO_SIDED|95.0|-0.09|0.35|||ANOVA|Mean and standard error are least squares means and corresponding standard errors based on an ANOVA model with main effects for treatment.||||0.35|-0.09|0.231
72558719|NCT02664415|144647414|SUPERIORITY|||||||1|||||||Fisher Exact|This is to confirm that the p-value from Fisher's Exact test was 1.000.||||||1.000
72558720|NCT02664415|144647415|SUPERIORITY|||||||0.051|||||||Log Rank|||A comparison of time from ATI to HIV-1 RNA \>= 20 copies/mL between arms.||||0.051
72438090|NCT00346151|144389096|SUPERIORITY_OR_OTHER||Incidence Rate|80.0||||||95.0|28.0|99.0|||95% exact binomial CI of proportion|||Proportion with 95% exact binomial confidence interval||99|28|
72558721|NCT02664415|144647415|SUPERIORITY|||||||0.01|||||||Log Rank|||A comparison of time from ATI to HIV-1 RNA \>= 1000 copies/mL between arms.||||0.01
72558722|NCT02664415|144647416|SUPERIORITY|||||||0.027||||||This is a p-value, comparing HIV-1 RNA levels at first detection between arms.|Wilcoxon (Mann-Whitney)|||||||0.027
72558723|NCT02664415|144647416|SUPERIORITY|||||||0.588||||||This is p-value, comparing HIV-1 RNA levels at ART resumption between arms.|Wilcoxon (Mann-Whitney)|||||||0.588
72618838|NCT06097273|144768198|SUPERIORITY|The superiority in SCR in the Cohort B1 group compared with that of Cohort B2 group was demonstrated if the lower bound of the 95% CI of the SCR difference was \>0%.|Percentage Difference|17.9|||||TWO_SIDED|95.0|14.8|21.0||||||Percentage Difference (Cohort B1 vs Cohort B2) for Influenza A H1N1 Antibody||21.0|14.8|
72438091|NCT00346151|144389097|SUPERIORITY_OR_OTHER||Incidence Rate|0.0||||||95.0|0.0|52.2|||95% exact binomial CI of proportion|||Proportion with 95% exact binomial confidence interval||52.2|0|
72438092|NCT00346151|144389098|SUPERIORITY_OR_OTHER||Incidence Rate|0.0||||||95.0|0.0|52.2|||95% exact binomial CI of proportion|||Proportion with 95% exact binomial confidence interval||52.2|0|
72438093|NCT00346151|144389099|SUPERIORITY_OR_OTHER||Incidence Rate|100.0||||||95.0|47.8|100.0|||95% exact binomial CI of proportion|||Proportion with 95% exact binomial confidence interval||100|47.8|
72438094|NCT00346151|144389100|SUPERIORITY_OR_OTHER||Incidence Rate|0.0||||||95.0|0.0|52.2|||95% exact binomial CI of proportion|||Proportion with 95% exact binomial confidence interval||52.2|0|
72438095|NCT00346151|144389101|SUPERIORITY_OR_OTHER||Incidence Rate|0.0||||||95.0|0.0|52.2|||95% exact binomial CI of proportion|||Proportion with 95% exact binomial confidence interval||52.2|0|
72438096|NCT00346151|144389102|SUPERIORITY_OR_OTHER||Incidence Rate|20.0||||||95.0|0.5|71.6|||95% exact binomial CI of proportion|||Proportion with 95% exact binomial confidence interval||71.6|0.5|
72438097|NCT00463788|144389140|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.126||||0.1109|TWO_SIDED|95.0|0.809|5.591|||Cochran-Mantel-Haenszel|Randomization strata: first- or second line according to Interactive Voice Response System (IVRS).||||5.591|0.809|0.1109
72438098|NCT00463788|144389141|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.675||||0.0324|TWO_SIDED|95.0|0.47|0.969|||Log Rank|||||0.969|0.470|0.0324
72438099|NCT00463788|144389142|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.821||||0.3121|TWO_SIDED|95.0|0.561|1.204|||Log Rank|||||1.204|0.561|0.3121
72558724|NCT02664415|144647417|SUPERIORITY|||||||0.031|||||||Log Rank|||||||0.031
72558725|NCT02664415|144647419|SUPERIORITY|||||||0.693|||||||Wilcoxon (Mann-Whitney)|||||||0.693
72495210|NCT02475655|144519398|SUPERIORITY||Mean Difference (Net)|-0.86||||0.39|TWO_SIDED|90.0|-2.51|0.8||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in inflammatory monocytes (CD14+CD16+) from Entry to Week 5.||0.80|-2.51|0.39
72558726|NCT02664415|144647420|SUPERIORITY|||||||0.15||||||The p-value is not adjusted for multiple comparisons.|Wilcoxon signed-rank test|||A comparison of total HIV DNA at baseline ATI and ART resumption within the VRC01 arm.||||0.15
72558727|NCT02664415|144647420|SUPERIORITY|||||||0.04||||||The p-value is not adjusted for multiple comparisons.|Wilcoxon signed-rank test|||A comparison of total HIV DNA at baseline ATI and ART resumption within the placebo arm.||||0.04
72558728|NCT02664415|144647420|SUPERIORITY|||||||0.002||||||The p-value is adjusted for multiple comparisons.|Wilcoxon signed-rank test|||A comparison of total HIV DNA at ART resumption and 6 months after ART resumption within the VRC01 arm.||||0.002
72558729|NCT02664415|144647420|SUPERIORITY|||||||0.22||||||The p-value is adjusted for multiple comparisons.|Wilcoxon signed-rank test|||A comparison of total HIV DNA at ART resumption and 6 months after ART resumption within the placebo arm.||||0.22
72438100|NCT00463788|144389143|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.754||||0.5993|TWO_SIDED|95.0|0.262|2.17|||Log Rank|||||2.170|0.262|0.5993
72438101|NCT00360698|144389145|SUPERIORITY_OR_OTHER||Risk Difference (RD)|13.68||||0.0499||95.0|0.01|28.37|||Chi-squared||Difference in percentage between groups: Insulin Glulisine+Insulin Glargine+Metformin+Glimepiride group - Insulin Glargine+Metformin+Glimepiride group|The null-hypothesis stated no differences between the 2 treatment groups regarding the percentage of patients with Glycosylated Haemoglobin (HbA1c) level \<7%. A sample size of 98 randomized (49/arm) patients would allow to demonstrate with 80% power that 40 % of patients in the Insulin Glulisine+Insulin Glargine+Metformin+Glimepiride group would achieve a HbA1c level \< 7 % compared to 15 % of patients in the Insulin Glargine+Metformin+Glimepiride group(5% alpha risk, 2-sided test).||28.37|0.01|0.0499
72438102|NCT00360698|144389147|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.26|STANDARD_ERROR_OF_MEAN|0.116||0.029||95.0|-0.49|-0.03||Threshold for statistical significance (alpha) = 0.05 ; 2 sided-test|ANCOVA|The analysis is an ANCOVA analysis on the change with group as fixed effect and baseline HbA1c as covariate|Difference between groups: Insulin Glulisine+Insulin Glargine+Metformin+Glimepiride group - Insulin Glargine+Metformin+Glimepiride group|The null-hypothesis stated no difference between the 2 treatment groups regarding the adjusted mean change from baseline in Glycosylated Haemoglobin (HbA1c) at the end of treatment.||-0.03|-0.49|0.029
72438103|NCT00360698|144389149|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-12.94|STANDARD_ERROR_OF_MEAN|4.987||0.0109||95.0|-22.83|-3.04||Threshold for statistical significance (alpha) = 0.05 ; 2 sided-test|ANCOVA|The analysis is an ANCOVA analysis on the change with group as fixed effect and baseline daily mean plasma glucose as covariate|Difference between groups: Insulin Glulisine+Insulin Glargine+Metformin+Glimepiride group - Insulin Glargine+Metformin+Glimepiride group|The null-hypothesis stated no differences between the 2 treatment groups regarding the adjusted mean change from baseline in daily mean plasma glucose at the end of treatment.||-3.04|-22.83|0.0109
72438104|NCT00360698|144389150|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.24|STANDARD_ERROR_OF_MEAN|0.431||0.5762||95.0|-0.61|1.1||Threshold for statistical significance (alpha) = 0.05 ; 2 sided-test|ANCOVA|The analysis is an ANCOVA analysis on the change with group as fixed effect and baseline weight as covariate|Difference between groups: Insulin Glulisine+Insulin Glargine+Metformin+Glimepiride group - Insulin Glargine+Metformin+Glimepiride group|The null-hypothesis stated no differences between the 2 treatment groups regarding the adjusted mean change from baseline in weight at the end of treatment.||1.1|-0.61|0.5762
72438105|NCT00360698|144389153|SUPERIORITY_OR_OTHER|||||||0.958||95.0||||Threshold for statistical significance (alpha) = 0.05 ; 2 sided-test|Wilcoxon (Mann-Whitney)|||The null-hypothesis stated no difference between the 2 treatment groups regarding the rate of symptomatic hypoglycemia with plasma glucose \<70 mg/dL during the treatment period.||||0.958
72438106|NCT00360698|144389154|SUPERIORITY_OR_OTHER|||||||0.302||95.0||||Threshold for statistical significance (alpha) = 0.05 ; 2 sided-test|Wilcoxon (Mann-Whitney)|||The null-hypothesis stated no difference between the 2 treatment groups regarding the rate of nocturnal symptomatic hypoglycemia with plasma glucose \<70 mg/dL during the treatment period.||||0.302
72438107|NCT00360698|144389155|SUPERIORITY_OR_OTHER|||||||0.192||95.0||||Threshold for statistical significance (alpha) = 0.05 ; 2 sided-test|Wilcoxon (Mann-Whitney)|||The null-hypothesis stated no difference between the 2 treatment groups regarding the rate of severe symptomatic hypoglycemia during the treatment period.||||0.192
72438108|NCT02547922|144389165|SUPERIORITY||Geometric Mean Ratio|1.031||||0.9052|TWO_SIDED|95.0|0.621|1.713||The p-values presented are unadjusted and was compared with the respective adjusted significance level (α). If α is not displayed, no formal testing can be performed and the corresponding p-value was nominal.|Mixed Models Analysis||Geometric mean ratio \>1 favours placebo.|The model includes fixed effects for treatment group, visit, stratification factors, log-transformed 24-hour UPCR at baseline, and treatment-by-visit interaction. All data up to and including the date of discontinuation of study treatment were included in the analysis.||1.713|0.621|0.9052
72438109|NCT02547922|144389166|SUPERIORITY||Difference in estimates|-0.08||||0.9929|TWO_SIDED|95.0|-16.92|16.76||At Week 52, the p-values presented are unadjusted and will be compared to the respective adjusted significance level (α). If α is not displayed no formal testing can be performed and the corresponding p-value is nominal.|Cochran-Mantel-Haenszel|||The statistical analysis represents the estimated percentage of responders. The responder/non-responder rates (percentages), the difference in estimates and associated 95% CI are weighted and are calculated using a stratified Cochran-Mantel-Haenszel (CMH) approach.||16.76|-16.92|0.9929
72438110|NCT02336438|144389177|SUPERIORITY_OR_OTHER|||||||0.99|TWO_SIDED||||||Wilcoxon Signed Rank Test|||||||0.99
72438111|NCT02336438|144389178|SUPERIORITY_OR_OTHER|||||||0.4922|TWO_SIDED||||||Wilcoxon Signed Rank Test|||||||0.4922
72438112|NCT02336438|144389179|SUPERIORITY_OR_OTHER|||||||0.77|TWO_SIDED||||||Wilcoxon Signed Rank Test|||||||0.77
72438113|NCT02336438|144389180|SUPERIORITY_OR_OTHER|||||||0.0156|TWO_SIDED||||||Wilcoxon Signed Rank Test|||||||0.0156
72438114|NCT02336438|144389181|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED||||||Wilcoxon Signed Rank Test|||||||0.020
72438115|NCT02336438|144389182|SUPERIORITY_OR_OTHER|||||||0.13|TWO_SIDED||||||Wilcoxon Signed Rank Test|||||||0.13
72438116|NCT00392054|144389209|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.56||||0.0016|TWO_SIDED|95.0|0.35|0.9||Cox regression analysis, stratified by clinical site, was performed and presented as hazard ratios with 95% confidence intervals and a two-sided p-value testing of less than or equal to 0.05 (two-sided) for the Wald test.|Regression, Cox|||Event rates were plotted over time using Kaplan-Meier methodology. Only events occurring after the 90-day treatment period were included in the final analysis. Treatment groups were analyzed on an intention-to-treat basis.||0.90|0.35|0.0016
72438117|NCT00392054|144389211|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.56||||0.03|TWO_SIDED|95.0|0.33|0.95|||Regression, Cox|||||0.95|0.33|0.03
72438118|NCT00392054|144389212|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.52||||0.017|TWO_SIDED|95.0|0.3|0.89|||Regression, Cox|||||0.89|0.3|0.017
72438119|NCT00392054|144389213|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.33|||<|0.0001|TWO_SIDED|95.0|0.28|0.4|||Regression, Cox|||||0.4|0.28|<0.0001
72438120|NCT00392054|144389214|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.86||||0.66|TWO_SIDED|95.0|0.42|1.72|||Regression, Cox|||||1.72|0.42|0.66
72438121|NCT04975308|144389217|SUPERIORITY||Hazard Ratio (HR)|0.867||||0.1158|TWO_SIDED|95.0|0.724|1.039|||Log Rank|||||1.039|0.724|0.1158
72438122|NCT04975308|144389218|SUPERIORITY||Hazard Ratio (HR)|0.569|||<|0.0001|TWO_SIDED|95.0|0.441|0.733|||Log Rank|||||0.733|0.441|<0.0001
72438123|NCT04975308|144389219|SUPERIORITY||Hazard Ratio (HR)|0.617||||0.0008|TWO_SIDED|95.0|0.464|0.821|||Log Rank|||||0.821|0.464|0.0008
72438124|NCT02709655|144389238|OTHER||Mean Difference (Final Values)|-2.09|STANDARD_ERROR_OF_MEAN|1.24||0.0937|TWO_SIDED|95.0|-4.54|0.36|||Mixed Models Analysis|||Analysis was performed using an REML-based MMRM approach with freely varying mean and covariance structure and with country, treatment (vortioxetine 10 mg/day, vortioxetine 20 mg/day, fluoxetine, and placebo), and Week as fixed factors and Baseline CDRS-R total score as a continuous covariate, the treatment-by-week interaction, and Baseline CDRS-R-by-Week interaction.||0.36|-4.54|0.0937
72438125|NCT02709655|144389238|OTHER||Mean Difference (Final Values)|-1.72|STANDARD_ERROR_OF_MEAN|1.44||0.2336|TWO_SIDED|95.0|-4.56|1.11|||Mixed Models Analysis|||Analysis was performed using an REML-based MMRM approach with freely varying mean and covariance structure and with country, treatment (vortioxetine 10 mg/day, vortioxetine 20 mg/day, fluoxetine, and placebo), and Week as fixed factors and Baseline CDRS-R total score as a continuous covariate, the treatment-by-week interaction, and Baseline CDRS-R-by-Week interaction.||1.11|-4.56|0.2336
72438126|NCT02709655|144389238|OTHER||Mean Difference (Final Values)|-2.46|STANDARD_ERROR_OF_MEAN|1.44||0.0879|TWO_SIDED|95.0|-5.29|0.37|||Mixed Models Analysis|||Analysis was performed using an REML-based MMRM approach with freely varying mean and covariance structure and with country, treatment (vortioxetine 10 mg/day, vortioxetine 20 mg/day, fluoxetine, and placebo), and Week as fixed factors and Baseline CDRS-R total score as a continuous covariate, the treatment-by-week interaction, and Baseline CDRS-R-by-Week interaction.||0.37|-5.29|0.0879
72438127|NCT02709655|144389238|OTHER||Mean Difference (Final Values)|-3.3|STANDARD_ERROR_OF_MEAN|1.7||0.0531|TWO_SIDED|95.0|-6.65|0.04|||Mixed Models Analysis|||Analysis was performed using an REML-based MMRM approach with freely varying mean and covariance structure and with country, treatment (vortioxetine 10 mg/day, vortioxetine 20 mg/day, fluoxetine, and placebo), and Week as fixed factors and Baseline CDRS-R total score as a continuous covariate, the treatment-by-week interaction, and Baseline CDRS-R-by-Week interaction.||0.04|-6.65|0.0531
72438128|NCT00102063|144389259|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||t-test, 2 sided|||||||0.05
72438129|NCT00102063|144389259|SUPERIORITY_OR_OTHER|||||||0.007||95.0|||||t-test, 2 sided|||||||0.007
72438130|NCT00857649|144389299|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.23|STANDARD_ERROR_OF_MEAN|1.52||0.418|TWO_SIDED|95.0|-1.75|4.21|||ANCOVA|Centre and treatment as factors and baseline score as covariate. Estimate based on Least Squares.||||4.21|-1.75|0.418
72438131|NCT00857649|144389300|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.48|STANDARD_ERROR_OF_MEAN|0.92||0.603|TWO_SIDED|95.0|-2.3|1.34|||ANCOVA|Centre and treatment as factors and baseline score as covariate. Estimate based on Least Squares.||||1.34|-2.30|0.603
72438132|NCT00857649|144389301|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.13||0.734|TWO_SIDED|95.0|-0.22|0.31|||ANCOVA|Centre and treatment as factors and baseline score as covariate. Estimate based on Least Squares.||||0.31|-0.22|0.734
72558730|NCT02664415|144647420|SUPERIORITY|||||||0.05|||||||Wilcoxon signed-rank test|||A comparison of total HIV DNA atbaseline ATI and 6 months after ART resumption within the VRC01 arm.||||0.05
72438133|NCT00857649|144389302|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.8|STANDARD_ERROR_OF_MEAN|0.75||0.017|TWO_SIDED|95.0|-3.29|-0.32|||ANCOVA|Centre and treatment as factors and baseline score as covariate. Estimate based on Least Squares.||||-0.32|-3.29|0.017
72438134|NCT00857649|144389303|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.9|STANDARD_ERROR_OF_MEAN|0.98||0.36|TWO_SIDED|95.0|-1.03|2.83|||ANCOVA|Centre and treatment as factors and baseline score as covariate. Estimate based on Least Squares.||||2.83|-1.03|0.360
72438135|NCT05190419|144389304|SUPERIORITY||Mean Difference (Net)|-35.4|STANDARD_ERROR_OF_MEAN|9.83|<|0.001|TWO_SIDED|95.0|-54.7|-16.0||No adjustment for multiplicity was made and the 0.05 level of significance was used to claim efficacy compared with placebo.|ANCOVA|p-value is calculated by analysis of covariance with treatment group as factor and baseline PASI as covariate.||||-16.0|-54.7|<0.001
72438136|NCT05190419|144389304|SUPERIORITY||Mean Difference (Net)|-43.9|STANDARD_ERROR_OF_MEAN|9.75|<|0.001|TWO_SIDED|95.0|-63.1|-24.8||No adjustment for multiplicity was made and the 0.05 level of significance was used to claim efficacy compared with placebo.|ANCOVA|p-value is calculated by analysis of covariance with treatment group as factor and baseline PASI as covariate.||||-24.8|-63.1|<0.001
72438137|NCT05190419|144389304|SUPERIORITY||Mean Difference (Net)|-46.4|STANDARD_ERROR_OF_MEAN|9.75|<|0.001|TWO_SIDED|95.0|-65.6|-27.3||No adjustment for multiplicity was made and the 0.05 level of significance was used to claim efficacy compared with placebo.|ANCOVA|p-value is calculated by analysis of covariance with treatment group as factor and baseline PASI as covariate.||||-27.3|-65.6|<0.001
72438138|NCT05323734|144389361|OTHER||Median Difference (Final Values)|-14.53||||0.0904|TWO_SIDED|95.0|-32.04|2.48|||Wilcoxon Rank-Sum|Wilcoxon Rank-Sum statistic is applied using a 2-sided significance level of 0.05.|The Hodges-Lehmann approach is applied for estimating 95% confidence interval.|||2.48|-32.04|0.0904
72558731|NCT02664415|144647420|SUPERIORITY|||||||0.22|||||||Wilcoxon signed-rank test|||A comparison of total HIV DNA at baeline ATI versus 6 months after ART resumption in the placebo arm||||0.22
72558732|NCT02664415|144647423|SUPERIORITY|||||||0.961|||||||Wilcoxon (Mann-Whitney)|||Comparison between arms at baseline ATI||||0.961
72558733|NCT02664415|144647423|SUPERIORITY|||||||0.805|||||||Wilcoxon (Mann-Whitney)|||Comparison between arms at ART resumption||||0.805
72438139|NCT05323734|144389362|OTHER||Difference in percentage|6.4||||0.3407|TWO_SIDED|95.0|-6.4|20.1|||Fisher Exact|||||20.1|-6.4|0.3407
72438140|NCT05323734|144389363|OTHER||Odds Ratio (OR)|0.88||||0.7069|TWO_SIDED|95.0|0.46|1.7|||Regression, Logistic||The estimated odds ratio of the ganaxolone group compared to the placebo group based on proportional odds logistic regression with treatment as a factor.|||1.70|0.46|0.7069
72438141|NCT05323734|144389364|OTHER||Odds Ratio (OR)|0.85||||0.6434|TWO_SIDED|95.0|0.42|1.72|||Regression, Logistic||The estimated odds ratio of the ganaxolone group compared to the placebo group based on proportional odds logistic regression with treatment as a factor.|||1.72|0.42|0.6434
72438142|NCT02486718|144389365|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.848||||0.0683|TWO_SIDED|95.0|0.71|1.013|||Log Rank|||||1.013|0.710|0.0683
72438143|NCT02486718|144389366|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.83|||||TWO_SIDED|95.0|0.691|0.998||||||||0.998|0.691|
72558734|NCT02664415|144647423|SUPERIORITY|||||||0.221|||||||Wilcoxon signed-rank test|||Comparison between Baseline and ART resumption within VRC01 arm.||||0.221
72618839|NCT06097273|144768198|NON_INFERIORITY|The noninferiority in SCR in the Cohort B1 group compared with that of Cohort B2 group was demonstrated if the lower bound of the 97.5% CI of the SCR difference was \>-10%.|Percentage Difference|17.9|||||TWO_SIDED|97.5|14.3|21.4||||||Percentage Difference (Cohort B1 vs Cohort B2) for Influenza A H1N1 Antibody||21.4|14.3|
72385661|NCT02833350|144278823|SUPERIORITY||Adjusted Difference|2.05||||0.6564|TWO_SIDED|95.0|-7.0|11.11|||Cochran-Mantel-Haenszel|||Week 4, Day 28||11.11|-7.00|0.6564
72558735|NCT02664415|144647423|SUPERIORITY|||||||0.5|||||||Wilcoxon signed-rank test|||Comparison between Baseline and ART resumption within Placebo arm.||||0.500
72558736|NCT02664415|144647424|SUPERIORITY|||||||0.522|||||||Wilcoxon (Mann-Whitney)|||Comparison between groups at baseline ATI.||||0.522
72558737|NCT02664415|144647424|SUPERIORITY|||||||0.961|||||||Wilcoxon (Mann-Whitney)|||A comparison between groups at ART resumption.||||0.961
72385662|NCT02833350|144278823|SUPERIORITY||Adjusted Difference|4.11||||0.3838|TWO_SIDED|95.0|-5.14|13.36|||Cochran-Mantel-Haenszel|||Week 8, Day 56||13.36|-5.14|0.3838
72385663|NCT02833350|144278823|SUPERIORITY||Adjusted Difference|0.68||||0.9009|TWO_SIDED|95.0|-10.1|11.47|||Cochran-Mantel-Haenszel|||Week 12, Day 84||11.47|-10.10|0.9009
72385664|NCT02833350|144278824|SUPERIORITY||Adjusted Difference|-2.36||||0.5455|TWO_SIDED|95.0|-7.0|2.27|||Cochran-Mantel-Haenszel|||Week 1, Day 7||2.27|-7.00|0.5455
72385665|NCT02833350|144278824|SUPERIORITY||Adjusted Difference|-1.97||||0.4114|TWO_SIDED|95.0|-5.3|1.36|||Cochran-Mantel-Haenszel|||Week 1, Day 7||1.36|-5.30|0.4114
72385666|NCT02833350|144278824|SUPERIORITY||Adjusted Difference|-2.62||||0.1739|TWO_SIDED|95.0|-5.97|0.72|||Cochran-Mantel-Haenszel|||Week 1, Day 7||0.72|-5.97|0.1739
72385667|NCT02833350|144278824|SUPERIORITY||Adjusted Difference|-0.94||||0.9761|TWO_SIDED|95.0|-5.93|4.06|||Cochran-Mantel-Haenszel|||Week 2, Week 14||4.06|-5.93|0.9761
72385668|NCT02833350|144278824|SUPERIORITY||Adjusted Difference|-3.18||||0.0998|TWO_SIDED|95.0|-6.78|0.41|||Cochran-Mantel-Haenszel|||Week 2, Week 14||0.41|-6.78|0.0998
72385669|NCT02833350|144278824|SUPERIORITY||Adjusted Difference|-3.97||||0.0239|TWO_SIDED|95.0|-7.54|-0.39|||Cochran-Mantel-Haenszel|||Week 2, Week 14||-0.39|-7.54|0.0239
72385670|NCT02833350|144278824|SUPERIORITY||Adjusted Difference|-3.98||||0.2018|TWO_SIDED|95.0|-9.25|1.3|||Cochran-Mantel-Haenszel|||Week 4, Day 28||1.30|-9.25|0.2018
72385671|NCT02833350|144278824|SUPERIORITY||Adjusted Difference|-5.67||||0.0011|TWO_SIDED|95.0|-9.48|-1.87|||Cochran-Mantel-Haenszel|||Week 4, Day 28||-1.87|-9.48|0.0011
72385672|NCT02833350|144278824|SUPERIORITY||Adjusted Difference|-5.27||||0.0026|TWO_SIDED|95.0|-9.06|-1.48|||Cochran-Mantel-Haenszel|||Week 4, Day 28||-1.48|-9.06|0.0026
72385673|NCT02833350|144278824|SUPERIORITY||Adjusted Difference|-2.47||||0.6336|TWO_SIDED|95.0|-7.84|2.9|||Cochran-Mantel-Haenszel|||Week 8, Day 56||2.90|-7.84|0.6336
72385674|NCT02833350|144278824|SUPERIORITY||Adjusted Difference|-3.49||||0.095|TWO_SIDED|95.0|-7.38|0.41|||Cochran-Mantel-Haenszel|||Week 8, Day 56||0.41|-7.38|0.0950
72385675|NCT02833350|144278824|SUPERIORITY||Adjusted Difference|-3.18||||0.1451|TWO_SIDED|95.0|-7.06|0.71|||Cochran-Mantel-Haenszel|||Week 8, Day 56||0.71|-7.06|0.1451
72385676|NCT02833350|144278824|SUPERIORITY||Adjusted Difference|-3.28||||0.3434|TWO_SIDED|95.0|-8.43|1.87|||Cochran-Mantel-Haenszel|||Week 12, Day 84||1.87|-8.43|0.3434
72385677|NCT02833350|144278824|SUPERIORITY||Adjusted Difference|-5.45||||0.0016|TWO_SIDED|95.0|-9.23|-1.68|||Cochran-Mantel-Haenszel|||Week 12, Day 84||-1.68|-9.23|0.0016
72385678|NCT02833350|144278824|SUPERIORITY||Adjusted Difference|-5.88||||0.0006|TWO_SIDED|95.0|-9.65|-2.1|||Cochran-Mantel-Haenszel|||Week 12, Day 84||-2.10|-9.65|0.0006
72385679|NCT02833350|144278824|SUPERIORITY||Adjusted Difference|4.64||||0.0025|TWO_SIDED|95.0|1.31|7.96|||Cochran-Mantel-Haenszel|||Week 1, Day 7||7.96|1.31|0.0025
72385680|NCT02833350|144278824|SUPERIORITY||Adjusted Difference|3.98||||0.0129|TWO_SIDED|95.0|0.64|7.32|||Cochran-Mantel-Haenszel|||Week 1, Day 7||7.32|0.64|0.0129
72385681|NCT02833350|144278824|SUPERIORITY||Adjusted Difference|4.04||||0.0206|TWO_SIDED|95.0|0.46|7.62|||Cochran-Mantel-Haenszel|||Week 2, Day 14||7.62|0.46|0.0206
72385682|NCT02833350|144278824|SUPERIORITY||Adjusted Difference|3.26||||0.0841|TWO_SIDED|95.0|-0.3|6.82|||Cochran-Mantel-Haenszel|||Week 2, Day 14||6.82|-0.30|0.0841
72385683|NCT02833350|144278824|SUPERIORITY||Adjusted Difference|4.67||||0.0088|TWO_SIDED|95.0|0.91|8.42|||Cochran-Mantel-Haenszel|||Week 4, Day 28||8.42|0.91|0.0088
72385684|NCT02833350|144278824|SUPERIORITY||Adjusted Difference|5.07||||0.0034|TWO_SIDED|95.0|1.34|8.81|||Cochran-Mantel-Haenszel|||Week 4, Day 28||8.81|1.34|0.0034
72385685|NCT02833350|144278824|SUPERIORITY||Adjusted Difference|4.55||||0.0138|TWO_SIDED|95.0|0.71|8.39|||Cochran-Mantel-Haenszel|||Week 8, Day 56||8.39|0.71|0.0138
72385686|NCT02833350|144278824|SUPERIORITY||Adjusted Difference|4.85||||0.0073|TWO_SIDED|95.0|1.02|8.69|||Cochran-Mantel-Haenszel|||Week 8, Day 56||8.69|1.02|0.0073
72385687|NCT02833350|144278824|SUPERIORITY||Adjusted Difference|1.29||||0.8284|TWO_SIDED|95.0|-2.46|5.03|||Cochran-Mantel-Haenszel|||Week 12, Day 84||5.03|-2.46|0.8284
72385688|NCT02833350|144278824|SUPERIORITY||Adjusted Difference|0.86||||0.9525|TWO_SIDED|95.0|-2.88|4.6|||Cochran-Mantel-Haenszel|||Week 12, Day 84||4.60|-2.88|0.9525
72385689|NCT02833350|144278824|SUPERIORITY||Adjusted Difference|-3.22||||0.0856|TWO_SIDED|95.0|-6.91|0.46|||Cochran-Mantel-Haenszel|||Week 1, Day 7||0.46|-6.91|0.0856
72385690|NCT02833350|144278824|SUPERIORITY||Adjusted Difference|-2.08||||0.3374|TWO_SIDED|95.0|-6.36|2.2|||Cochran-Mantel-Haenszel|||Week 2, Day 14||2.20|-6.36|0.3374
72385691|NCT02833350|144278824|SUPERIORITY||Adjusted Difference|-4.24||||0.0534|TWO_SIDED|95.0|-8.53|0.06|||Cochran-Mantel-Haenszel|||Week 4, Day 28||0.06|-8.53|0.0534
72385692|NCT02833350|144278824|SUPERIORITY||Adjusted Difference|-10.8|||<|0.0001|TWO_SIDED|95.0|-15.33|-6.32|||Cochran-Mantel-Haenszel|||Week 8, Day 56||-6.32|-15.33|<0.0001
72385693|NCT02833350|144278824|SUPERIORITY||Adjusted Difference|-9.22|||<|0.0001|TWO_SIDED|95.0|-13.63|-4.81|||Cochran-Mantel-Haenszel|||Week 12, Day 84||-4.81|-13.63|<0.0001
72385694|NCT02833350|144278825|SUPERIORITY||Adjusted Difference|0.0||||1|TWO_SIDED|95.0|-6.06|6.06|||Cochran-Mantel-Haenszel|||Week 1, Day 7||6.06|-6.06|1.0000
72618840|NCT06097273|144768198|SUPERIORITY|The superiority in SCR in the Cohort B1 group compared with that of Cohort B2 group was demonstrated if the lower bound of the 95% CI of the SCR difference was \>0%.|Percentage Difference|14.6|||||TWO_SIDED|95.0|11.6|17.6||||||Percentage Difference (Cohort B1 vs Cohort B2) for Influenza A H3N2 Antibody||17.6|11.6|
72438144|NCT02486718|144389367|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.704|||||TWO_SIDED|95.0|0.545|0.91||||||||0.910|0.545|
72438145|NCT02486718|144389369|SUPERIORITY||Difference in event-free rates|5.98|||||TWO_SIDED|95.0|-0.28|12.23||||||||12.23|-0.28|
72438146|NCT02486718|144389370|SUPERIORITY||Difference in event-free rates|6.65|||||TWO_SIDED|95.0|-0.06|13.36||||||||13.36|-0.06|
72438147|NCT02486718|144389371|SUPERIORITY||Difference in event-free rates|10.67|||||TWO_SIDED|95.0|1.56|19.79||||||||19.79|1.56|
72385695|NCT02833350|144278825|SUPERIORITY||Adjusted Difference|0.91||||0.5976|TWO_SIDED|95.0|-2.48|4.3|||Cochran-Mantel-Haenszel|||Week 1, Day 7||4.30|-2.48|0.5976
72385696|NCT02833350|144278825|SUPERIORITY||Adjusted Difference|0.0||||1|TWO_SIDED|95.0|-2.91|2.91|||Cochran-Mantel-Haenszel|||Week 1, Day 7||2.91|-2.91|1.0000
72385697|NCT02833350|144278825|SUPERIORITY||Adjusted Difference|0.0||||1|TWO_SIDED|95.0|-6.06|6.06|||Cochran-Mantel-Haenszel|||Week 2, Day 14||6.06|-6.06|1.0000
72385698|NCT02833350|144278825|SUPERIORITY||Adjusted Difference|0.0||||1|TWO_SIDED|95.0|-2.92|2.92|||Cochran-Mantel-Haenszel|||Week 2, Day 14||2.92|-2.92|1.0000
72385699|NCT02833350|144278825|SUPERIORITY||Adjusted Difference|0.0||||1|TWO_SIDED|95.0|-2.91|2.91|||Cochran-Mantel-Haenszel|||Week 2, Day 14||2.91|-2.91|1.0000
72385700|NCT02833350|144278825|SUPERIORITY||Adjusted Difference|0.0||||1|TWO_SIDED|95.0|-6.06|6.06|||Cochran-Mantel-Haenszel|||Week 4, Day 28||6.06|-6.06|1.0000
72385701|NCT02833350|144278825|SUPERIORITY||Adjusted Difference|0.91||||0.5726|TWO_SIDED|95.0|-2.26|4.09|||Cochran-Mantel-Haenszel|||Week 4, Day 28||4.09|-2.26|0.5726
72385702|NCT02833350|144278825|SUPERIORITY||Mean Difference (Net)|0.91||||0.5976|TWO_SIDED|95.0|-2.47|4.28|||Cochran-Mantel-Haenszel|||Week 4, Day 28||4.28|-2.47|0.5976
72385703|NCT02833350|144278825|SUPERIORITY||Adjusted Difference|0.0||||1|TWO_SIDED|95.0|-6.06|6.06|||Cochran-Mantel-Haenszel|||Week 8, Day 56||6.06|-6.06|1.0000
72385704|NCT02833350|144278825|SUPERIORITY||Adjusted Difference|2.74||||0.1446|TWO_SIDED|95.0|-0.94|6.42|||Cochran-Mantel-Haenszel|||Week 8, Day 56||6.42|-0.94|0.1446
72385705|NCT02833350|144278825|SUPERIORITY||Adjusted Difference|3.64||||0.105|TWO_SIDED|95.0|-0.76|8.03|||Cochran-Mantel-Haenszel|||Week 8, Day 56||8.03|-0.76|0.1050
72385706|NCT02833350|144278825|SUPERIORITY||Adjusted Difference|-0.4||||0.8979|TWO_SIDED|95.0|-6.51|5.71|||Cochran-Mantel-Haenszel|||Week 12, Day 84||5.71|-6.51|0.8979
72385707|NCT02833350|144278825|SUPERIORITY||Adjusted Difference|3.65||||0.127|TWO_SIDED|95.0|-1.04|8.35|||Cochran-Mantel-Haenszel|||Week 12, Day 84||8.35|-1.04|0.1270
72385708|NCT02833350|144278825|SUPERIORITY||Adjusted Difference|5.45||||0.0501|TWO_SIDED|95.0|0.0|10.91|||Cochran-Mantel-Haenszel|||Week 12, Day 84||10.91|-0.00|0.0501
72385709|NCT02833350|144278825|SUPERIORITY||Adjusted Difference|0.0||||1|TWO_SIDED|95.0|-8.31|8.31|||Cochran-Mantel-Haenszel|||Week 1, Day 7||8.31|-8.31|1.0000
72385710|NCT02833350|144278825|SUPERIORITY||Adjusted Difference|0.0||||1|TWO_SIDED|95.0|-8.31|8.31|||Cochran-Mantel-Haenszel|||Week 2, Day 14||8.31|-8.31|1.0000
72385711|NCT02833350|144278825|SUPERIORITY||Adjusted Difference|2.05||||0.6564|TWO_SIDED|95.0|-7.0|11.11|||Cochran-Mantel-Haenszel|||Week 4, Day 28||11.11|-7.00|0.6564
72385712|NCT02833350|144278825|SUPERIORITY||Adjusted Difference|0.0||||1|TWO_SIDED|95.0|-8.31|8.31|||Cochran-Mantel-Haenszel|||Week 8, Day 56||8.31|-8.31|1.0000
72385713|NCT02833350|144278825|SUPERIORITY||Adjusted Difference|0.68||||0.9051|TWO_SIDED|95.0|-10.58|11.95|||Cochran-Mantel-Haenszel|||Week 12, Day 84||11.95|-10.58|0.9051
72385714|NCT01856907|144278858|SUPERIORITY|||||||0.035|||||||McNemar|||Study change from dysglycemia to normal glucose state||||.035
72385715|NCT01856907|144278859|SUPERIORITY|||||||0.044|||||||ANOVA|||Subjects (SS)/ Treatment Group x repeated measures (visit) design||||0.044
72385716|NCT01856907|144278860|SUPERIORITY|||||||0.034|||||||ANOVA|||Factorial repeated measures ANOVA with Bonferroni contrast test||||0.034
72385717|NCT01856907|144278861|SUPERIORITY|||||||0.047|||||||ANOVA|||Factorial repeated measures ANOVA with Bonferroni contrast test||||.047
72385718|NCT01856907|144278862|SUPERIORITY|||||||0.017|||||||ANOVA|||Factorial repeated measures ANOVA with Bonferroni contrast test||||0.017
72385719|NCT01856907|144278863|SUPERIORITY|||||||0.014|||||||ANOVA|||Factorial repeated measures ANOVA with Bonferroni contrast test||||0.014
72385720|NCT01856907|144278864|SUPERIORITY|||||||0.042|||||||ANOVA|||Factorial repeated measures ANOVA with Bonferroni contrast test||||0.042
72385721|NCT01856907|144278865|SUPERIORITY|||||||0.002|||||||ANOVA|||Factorial repeated measures ANOVA with Bonferroni contrast test||||0.002
72385722|NCT01856907|144278866|SUPERIORITY|||||||0.004|||||||ANOVA|||Factorial repeated measures ANOVA with Bonferroni contrast test||||0.004
72385723|NCT01856907|144278867|SUPERIORITY|||||||0.004|||||||ANOVA|||Factorial repeated measures ANOVA with Bonferroni contrast test||||0.004
72385724|NCT01856907|144278868|SUPERIORITY|||||||0.9|||||||Fisher Exact|||||||0.9
72385725|NCT01604408|144278869|SUPERIORITY_OR_OTHER||LS Mean Difference|0.426|||<|0.001|TWO_SIDED|95.0|0.192|0.66|||Mixed Model Repeated Measures|||||0.660|0.192|<0.001
72385726|NCT01604408|144278870|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.461||||0.073|TWO_SIDED|90.0|-0.883|-0.039|||Mixed Model Repeated Measures|||||-0.039|-0.883|0.073
72385727|NCT01604408|144278871|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.062||||0.191|TWO_SIDED|90.0|-2.4|0.276|||Mixed Model Repeated Measures|||||0.276|-2.400|0.191
72385728|NCT01604408|144278872|SUPERIORITY_OR_OTHER||LS Mean Difference|0.017||||0.478|TWO_SIDED|90.0|-0.023|0.057|||Mixed Model Repeated Measures|||||0.057|-0.023|0.478
72385729|NCT01904058|144278940|SUPERIORITY_OR_OTHER||Least squares mean difference|-2.28||||0.6603|TWO_SIDED|95.0|-12.59|8.03||p-value (LUM001 LS Mean = Placebo LS Mean).|ANCOVA|||The difference between treatment groups in change from Baseline to Week 13/ET in ItchRO weekly sum score evaluated by analysis of covariance (ANCOVA) using generalized linear model (GLM). The model included terms for treatment group, alkaline phosphatase (ALP) level (strata), treatment group by ALP level interaction and Baseline ItchRO weekly sum score as a covariate. Least squares mean change from Baseline to Week 13/ET, along with 95 percentage (%) confidence interval for mean were presented.||8.03|-12.59|0.6603
72558738|NCT02664415|144647424|SUPERIORITY|||||||0.002|||||||Wilcoxon signed-rank test|||A comparison between baseline ATI and ART resumption within VRC01 group.||||0.002
72438148|NCT02486718|144389372|SUPERIORITY||Difference in event-free rates|5.48|||||TWO_SIDED|95.0|-0.94|11.9||||||||11.90|-0.94|
72438149|NCT02486718|144389373|SUPERIORITY||Difference in event-free rates|4.88|||||TWO_SIDED|95.0|-1.94|11.7||||||||11.70|-1.94|
72438150|NCT02486718|144389374|SUPERIORITY||Difference in event-free rates|10.46|||||TWO_SIDED|95.0|1.16|19.76||||||||19.76|1.16|
72438151|NCT02486718|144389375|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.503|||||TWO_SIDED|95.0|0.332|0.761||||||||0.761|0.332|
72438152|NCT05061693|144389382|SUPERIORITY||Odds Ratio (OR)|7.1||||0.0061|TWO_SIDED|95.0|1.6|45.4|||Regression, Logistic|Exact Logistic regression: (response at Week 16 = treatment + stratification factor \[Day 1 Investigator's Global Assessment score (3 or 4)\])||||45.4|1.6|0.0061
72438153|NCT05061693|144389382|SUPERIORITY||difference in response rate|28.0|STANDARD_ERROR_OF_MEAN|9.18|||TWO_SIDED|95.0|||||||The standard error of the difference between response rates was from normal approximation.|||||
72438154|NCT05061693|144389382|SUPERIORITY||Odds Ratio (OR)|10.2||||0.0005|TWO_SIDED|95.0|2.3|65.6|||Regression, Logistic|Exact Logistic regression: (response at Week 16 = treatment + stratification factor \[Day 1 Investigator's Global Assessment score (3 or 4)\])||||65.6|2.3|0.0005
72438155|NCT05061693|144389382|SUPERIORITY||difference in response rate|36.3|STANDARD_ERROR_OF_MEAN|9.42|||TWO_SIDED|95.0|||||||The standard error of the difference between response rates was from normal approximation.|||||
72438156|NCT05061693|144389382|SUPERIORITY||Odds Ratio (OR)|16.8|||<|0.0001|TWO_SIDED|95.0|3.9|107.5|||Regression, Logistic|Exact Logistic regression: (response at Week 16 = treatment + stratification factor \[Day 1 Investigator's Global Assessment score (3 or 4)\])||||107.5|3.9|<0.0001
72438157|NCT05061693|144389382|SUPERIORITY||difference in response rate|48.6|STANDARD_ERROR_OF_MEAN|9.3|||TWO_SIDED|95.0|||||||The standard error of the difference between response rates was from normal approximation.|||||
72438158|NCT01152190|144389391|SUPERIORITY_OR_OTHER||Difference in LS Means|0.01|STANDARD_ERROR_OF_MEAN|0.009||0.121||95.0||||The p-value associated with the LS mean difference of change from baseline to Week 8 between the tadalafil and placebo treatment groups was tested at a significance level of 0.05 with no adjustments for multiplicity.|Mixed-Model Repeated Measures|||||||0.121
72558739|NCT02664415|144647424|SUPERIORITY|||||||0.043|||||||Wilcoxon signed-rank test|||A comparison between baseline ATI and ART resumption within Placebo group.||||0.043
72558740|NCT00128219|144647425|SUPERIORITY_OR_OTHER||Vaccine Efficacy, VE=1-RR=1-exp(ß)|36.0||||0.044|TWO_SIDED|95.0|1.0|58.0||The a priori threshold for statistical significance was set at 0.05.|Regression, Cox|The study was multi-center, and the Cox model was stratified by geographic region of the participating clinical sites.|Vaccine efficacy (VE) was defined as one minus the relative risk (RR), which was estimated by exponentiating the treatment parameter (ß) from the Cox model fit.|Time to first acquisition of vaginal type III GBS was analyzed by fitting a Cox Proportional Hazards model stratified by region to the data. The null hypothesis of no vaccine efficacy was tested by the stratified log-rank test (score test). The point and interval estimates for vaccine efficacy were obtained by transforming those for treatment effect in the model.||58|1|0.044
72618841|NCT06097273|144768198|NON_INFERIORITY|The noninferiority in SCR in the Cohort B1 group compared with that of Cohort B2 group was demonstrated if the lower bound of the 97.5% CI of the SCR difference was \>-10%.|Percentage Difference|14.6|||||TWO_SIDED|97.5|11.1|18.0||||||Percentage Difference (Cohort B1 vs Cohort B2) for Influenza A H3N2 Antibody||18.0|11.1|
72438159|NCT01152190|144389392|SUPERIORITY_OR_OTHER||Difference in LS Means|0.01|STANDARD_ERROR_OF_MEAN|0.008||0.226||95.0||||The p-value associated with the LS mean difference of change from baseline to Week 4 between the tadalafil and placebo treatment groups was tested at a significance level of 0.05 with no adjustments for multiplicity.|Mixed-Model Repeated Measures|||||||0.226
72438160|NCT01152190|144389393|SUPERIORITY_OR_OTHER||Difference in LS Means|0.01|STANDARD_ERROR_OF_MEAN|0.009||0.208||95.0||||The p-value associated with the LS mean difference of change from baseline to Week 4 in the prostate peripheral zone RI was tested at a significance level of 0.05 with no adjustments for multiplicity.|Mixed-Model Repeated Measures|||||||0.208
72438161|NCT01152190|144389393|SUPERIORITY_OR_OTHER||Difference in LS Means|0.02|STANDARD_ERROR_OF_MEAN|0.009||0.066||95.0||||The p-value associated with the LS mean difference of change from baseline to Week 8 in the prostate peripheral zone RI was tested at a significance level of 0.05 with no adjustments for multiplicity.|Mixed-Model Repeated Measures|||||||0.066
72438162|NCT01152190|144389393|SUPERIORITY_OR_OTHER||Difference in LS Means|0.02|STANDARD_ERROR_OF_MEAN|0.017||0.195||95.0||||The p-value associated with the LS mean difference of change from baseline to Week 4 in bladder neck RI was tested at a significance level of 0.05 with no adjustments for multiplicity.|Mixed-Model Repeated Measures|||||||0.195
72438163|NCT01152190|144389393|SUPERIORITY_OR_OTHER||Difference in LS Means|0.01|STANDARD_ERROR_OF_MEAN|0.022||0.625||95.0||||The p-value associated with the LS mean difference of change from baseline to Week 8 in bladder neck RI was tested at a significance level of 0.05 with no adjustments for multiplicity.|Mixed-Model Repeated Measures|||||||0.625
72438164|NCT01152190|144389394|SUPERIORITY_OR_OTHER||Difference in LS Means|2.63|STANDARD_ERROR_OF_MEAN|3.38||0.439||95.0||||The p-value associated with the LS mean difference of change from baseline to Week 4 in the prostate transition zone CPI was tested at a significance level of 0.05 with no adjustments for multiplicity.|Mixed-Model Repeated Measures|||||||0.439
72618842|NCT06097273|144768198|SUPERIORITY|The superiority in SCR in the Cohort B1 group compared with that of Cohort B2 group was demonstrated if the lower bound of the 95% CI of the SCR difference was \>0%.|Percentage Difference|8.6|||||TWO_SIDED|95.0|6.0|11.2||||||Percentage Difference (Cohort B1 vs Cohort B2) for Victoria-lineage Antibody||11.2|6.0|
72438165|NCT01152190|144389394|SUPERIORITY_OR_OTHER||Difference in LS Means|0.51|STANDARD_ERROR_OF_MEAN|2.867||0.86||95.0||||The p-value associated with the LS mean difference of change from baseline to Week 8 in the prostate transition zone CPI was tested at a significance level of 0.05 with no adjustments for multiplicity.|Mixed-Model Repeated Measures|||||||0.860
72438166|NCT01152190|144389394|SUPERIORITY_OR_OTHER||Difference in LS Means|3.47|STANDARD_ERROR_OF_MEAN|2.937||0.24||95.0||||The p-value associated with the LS mean difference of change from baseline to Week 4 in the prostate peripheral zone CPI was tested at a significance level of 0.05 with no adjustments for multiplicity.|Mixed-Model Repeated Measures|||||||0.240
72438167|NCT01152190|144389394|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.55|STANDARD_ERROR_OF_MEAN|2.729||0.839||95.0||||The p-value associated with the LS mean difference of change from baseline to Week 8 in the prostate peripheral zone CPI was tested at a significance level of 0.05 with no adjustments for multiplicity.|Mixed-Model Repeated Measures|||||||0.839
72438168|NCT01152190|144389394|SUPERIORITY_OR_OTHER||Difference in LS Means|-4.2|STANDARD_ERROR_OF_MEAN|5.77||0.468||95.0||||The p-value associated with the LS mean difference of change from baseline to Week 4 in the bladder neck CPI was tested at a significance level of 0.05 with no adjustments for multiplicity.|Mixed-Model Repeated Measures|||||||0.468
72438169|NCT01152190|144389394|SUPERIORITY_OR_OTHER||Difference in LS Means|7.93|STANDARD_ERROR_OF_MEAN|5.199||0.131||95.0||||The p-value associated with the LS mean difference of change from baseline to Week 8 in the bladder neck CPI was tested at a significance level of 0.05 with no adjustments for multiplicity.|Mixed-Model Repeated Measures|||||||0.131
72438170|NCT00442117|144389445|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.074||||0.4982|TWO_SIDED|95.0|-4.196|2.049|||ANOVA|||||2.049|-4.196|0.4982
72438171|NCT00442117|144389446|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.7601||||0.6544|TWO_SIDED|95.0|-2.585|4.106|||ANOVA|||||4.106|-2.585|0.6544
72438172|NCT00442117|144389447|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.704||||0.3796|TWO_SIDED|95.0|-5.528|2.115|||ANOVA|||||2.115|-5.528|0.3796
72438173|NCT00442117|144389448|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.432||||0.9622|TWO_SIDED|95.0|-17.56|18.24|||ANOVA|||||18.240|-17.560|0.9622
72438174|NCT00516321|144389473|SUPERIORITY_OR_OTHER||Percentage difference in SVR|7.9||||0.0064|TWO_SIDED|95.0|2.4|13.4||Stratified Cochran-Mantel-Haenszel (CMH) chi-square test adjusted for the randomization strata|Cochran-Mantel-Haenszel||The estimated value reflects the percentage of participants with SVR in the eltrombopag group minus the percentage of participants with SVR in the placebo group. Adjusted for the actual strata: HCV genotype, baseline platelet count, and HCV RNA.|||13.4|2.4|0.0064
72438175|NCT01765543|144389499|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.614|||||TWO_SIDED|90.0|0.484|0.78||||||Analysis of variance (ANOVA) was applied to the log-transformed PK parameters, and then back transformed to provide geometric mean ratio (Period C/Period A) and confidence intervals.||0.780|0.484|
72438176|NCT01765543|144389500|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.596|||||TWO_SIDED|90.0|0.469|0.759||||||ANOVA was applied to the log-transformed PK parameters, and then back transformed to provide geometric mean ratio (Period C/Period A) and confidence intervals.||0.759|0.469|
72438177|NCT01765543|144389501|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.11|||||TWO_SIDED|90.0|0.908|1.36||||||ANOVA was applied to the log-transformed PK parameters, and then back transformed to provide geometric mean ratio (Period C/Period A) and confidence intervals.||1.36|0.908|
72438178|NCT01574807|144389511|SUPERIORITY||Percentage difference|0.0||||1|TWO_SIDED|||||Multiple McNemar tests corrected with Step-down Bonferroni method of Holm. A priori threshold for significance was 0.05.|McNemar|||||||1.00
72438179|NCT04303156|144389512|OTHER||GMR|2.2|||||TWO_SIDED|90.0|1.68|2.88|||||Severe Renal Impairment / Healthy|Geometric mean ratio (GMR)|GMR calculated using the mean square error referencing a t-distribution. Confidence limits exponentiated to obtain the 90% confidence interval.|2.88|1.68|
72438180|NCT04303156|144389513|OTHER||GMR|1.93|||||TWO_SIDED|90.0|1.46|2.55|||||Severe Renal Impairment / Healthy|GMR|GMR calculated using the mean square error referencing a t-distribution. Confidence limits exponentiated to obtain the 90% confidence interval.|2.55|1.46|
72438181|NCT04303156|144389514|OTHER||GMR|1.03|||||TWO_SIDED|90.0|0.67|1.57|||||Severe Renal Impairment / Healthy|GMR|GMR calculated using the mean square error referencing a t-distribution. Confidence limits exponentiated to obtain the 90% confidence interval.|1.57|0.67|
72438182|NCT04303156|144389517|OTHER||GMR|0.46|||||TWO_SIDED|90.0|0.35|0.6|||||Severe Renal Impairment / Healthy|GMR|GMR calculated using the mean square error referencing a t-distribution. Confidence limits exponentiated to obtain the 90% confidence interval.|0.60|0.35|
72438183|NCT04303156|144389518|OTHER||GMR|0.8|||||TWO_SIDED|90.0|0.56|1.14|||||Severe Renal Impairment / Healthy|GMR|GMR calculated using the mean square error referencing a t-distribution. Confidence limits exponentiated to obtain the 90% confidence interval.|1.14|0.56|
72438184|NCT04303156|144389519|OTHER||GMR|1.48|||||TWO_SIDED|90.0|1.03|2.14|||||Severe Renal Impairment / Healthy|GMR|GMR calculated using the mean square error referencing a t-distribution. Confidence limits exponentiated to obtain the 90% confidence interval.|2.14|1.03|
72438185|NCT04303156|144389520|OTHER||GMR|1.38|||||TWO_SIDED|90.0|0.98|1.93|||||Severe Renal Impairment / Healthy|GMR|GMR calculated using the mean square error referencing a t-distribution. Confidence limits exponentiated to obtain the 90% confidence interval.|1.93|0.98|
72438186|NCT04303156|144389521|OTHER||GMR|0.94|||||TWO_SIDED|90.0|0.64|1.39|||||Severe Renal Impairment / Healthy|GMR|GMR calculated using the mean square error referencing a t-distribution. Confidence limits exponentiated to obtain the 90% confidence interval.|1.39|0.64|
72438187|NCT04303156|144389523|OTHER||GMR|0.97|||||TWO_SIDED|90.0|0.69|1.35|||||Severe Renal Impairment / Healthy|GMR|GMR calculated using the mean square error referencing a t-distribution. Confidence limits exponentiated to obtain the 90% confidence interval.|1.35|0.69|
72438188|NCT04303156|144389524|OTHER||GMR|1.82|||||TWO_SIDED|90.0|0.55|6.02|||||Severe Renal Impairment / Healthy|GMR|GMR calculated using the mean square error referencing a t-distribution. Confidence limits exponentiated to obtain the 90% confidence interval.|6.02|0.55|
72438189|NCT04303156|144389525|OTHER||GMR|2.69|||||TWO_SIDED|90.0|1.51|4.8|||||Severe Renal Impairment / Healthy|GMR|GMR calculated using the mean square error referencing a t-distribution. Confidence limits exponentiated to obtain the 90% confidence interval.|4.80|1.51|
72438190|NCT03401112|144389555|SUPERIORITY|||||||0.0686|||||||Log Rank|||||||0.0686
72438191|NCT03401112|144389555|SUPERIORITY|||||||0.0294|||||||Log Rank|||||||0.0294
72438192|NCT02248480|144389613|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||Mixed Models Analysis|||||||<.0001
72438193|NCT01579916|144389749|NON_INFERIORITY_OR_EQUIVALENCE|H0 (null): Rate difference greater than or equal to 5 percentage points. This corresponds to a null hypothesis of: HA (alternative): rate difference \< 5 percentage points.|Rate difference|-1.7|||||TWO_SIDED|95.0|-8.9|0.6|||Score statistic|||Comparison of the rate of fever between the 2 treatment groups was based on the upper limit of the two-sided 95% exact confidence intervals (CIs) for the rate increase (trivalent influenza virus vaccine minus placebo) evaluated against the prespecified equivalence criterion of 5 percentage points||0.6|-8.9|
72438194|NCT00385801|144389768|SUPERIORITY_OR_OTHER|||||||0.86||||||The effect of treatment on intensity of craving was assessed and the threshold for statistical significance was p \< 0.05|Mixed Models Analysis|F=0.03||Intensity of craving||||0.86
72438195|NCT03603717|144389788|SUPERIORITY||||||<|0.01|||||||Mixed Models Analysis|||||||<0.01
72438196|NCT03603717|144389789|SUPERIORITY|||||||0.03|||||||Mixed Models Analysis|||||||0.03
72438197|NCT03603717|144389790|SUPERIORITY|||||||0.84|||||||Mixed Models Analysis|||||||0.84
72438198|NCT03603717|144389791|SUPERIORITY|||||||0.01|||||||Mixed Models Analysis|||||||0.01
72438199|NCT00732381|144389792|SUPERIORITY_OR_OTHER_LEGACY|||||||0.006||95.0|||||ANCOVA|||||||0.006
72438200|NCT00732381|144389793|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||ANCOVA|||||||<.001
72438203|NCT03622593|144389857|NON_INFERIORITY|If the lower bound of the two-sided 97.52% confidence interval for the difference in adjusted means for the faricimab 6 mg Q8W and the active comparator (aflibercept 2 mg Q8W) arms was greater than -4 letters, then faricimab 6 mg Q8W was considered non-inferior to aflibercept 2 mg Q8W. Non-inferiority was tested one-sided at a significance level of α = 0.0248.|Adjusted mean difference|1.5|STANDARD_ERROR_OF_MEAN|0.73|||TWO_SIDED|97.5|-0.1|3.2|||||The difference in adjusted means was calculated as Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W in the ITT Population.|Three hypotheses were tested in order for each faricimab arm (Q8W or PTI) separately against the aflibercept arm using a graph-based testing procedure. The analysis presented here is for the non-inferiority of Arm A: Faricimab 6 mg Q8W compared with Arm C: Aflibercept 2 mg Q8W in the ITT Population.||3.2|-0.1|
72558741|NCT00128219|144647450|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.46||||0.12|TWO_SIDED|95.0|0.917|2.34||The a priori threshold for statistical significance for the analysis of secondary endpoints was set at .05 without adjustment for multiplicity.|Fisher Exact|Fisher's exact test was used to test no difference in proportions always vaginal GBS-III negative by arm to a two-sided alternative of a difference.|The OR was calculated from the 2x2 contingency table, and the 95% CI was obtained by inverting the 2-sided 5% level Fisher's exact, with GBS III-TT arm in the numerator and Td arm in the denominator so \<1 favors the GBS III-TT arm.|A two-sided 5% level Fisher's exact test was used to test the null hypothesis of no difference in proportion of participants who were vaginal type III GBS negative throughout the study between treatment arms. The two-sided 5% Fisher's exact test was inverted to obtain a 95% confidence interval for the odds ratio.||2.34|0.917|0.120
72438204|NCT03622593|144389857|NON_INFERIORITY|If the lower bound of the two-sided 97.52% confidence interval for the difference in adjusted means for the faricimab 6 mg PTI and the active comparator (aflibercept 2 mg Q8W) arms was greater than -4 letters, then faricimab 6 mg PTI was considered non-inferior to aflibercept 2 mg Q8W. Non-inferiority was tested one-sided at a significance level of α = 0.0248.|Adjusted mean difference|0.5|STANDARD_ERROR_OF_MEAN|0.73|||TWO_SIDED|97.5|-1.1|2.1|||||The difference in adjusted means was calculated as Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W in the ITT Population.|Three hypotheses were tested in order for each faricimab arm (Q8W or PTI) separately against the aflibercept arm using a graph-based testing procedure. The analysis presented here is for the non-inferiority of Arm B: Faricimab 6 mg PTI compared with Arm C: Aflibercept 2 mg Q8W in the ITT Population.||2.1|-1.1|
72438205|NCT03622593|144389857|SUPERIORITY||Adjusted mean difference|1.1|STANDARD_ERROR_OF_MEAN|0.83||0.1718|TWO_SIDED|97.5|-0.7|3.0||Tested at an overall significance level of α = 0.0248.|Mixed Model for Repeated Measures||The difference in adjusted means was calculated as Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W in the Treatment-Naive Population.|Three hypotheses were tested in order for each faricimab arm (Q8W or PTI) separately against the aflibercept arm using a graph-based testing procedure. The analysis presented here is for the superiority of Arm A: Faricimab 6 mg Q8W compared with Arm C: Aflibercept 2 mg Q8W in the Treatment-Naive Population.||3.0|-0.7|0.1718
72438206|NCT03622593|144389857|SUPERIORITY||Adjusted mean difference|0.6|STANDARD_ERROR_OF_MEAN|0.82||0.4602|TWO_SIDED|97.5|-1.2|2.4||Tested at an overall significance level of α = 0.0248.|Mixed Model for Repeated Measures||The difference in adjusted means was calculated as Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W in the Treatment-Naive Population.|Three hypotheses were tested in order for each faricimab arm (Q8W or PTI) separately against the aflibercept arm using a graph-based testing procedure. The analysis presented here is for the superiority of Arm B: Faricimab 6 mg PTI compared with Arm C: Aflibercept 2 mg Q8W in the Treatment-Naive Population.||2.4|-1.2|0.4602
72438207|NCT03622593|144389857|SUPERIORITY||Adjusted mean difference|1.5|STANDARD_ERROR_OF_MEAN|0.73||0.0361|TWO_SIDED|97.5|-0.1|3.2||Tested at an overall significance level of α = 0.0248.|Mixed Model for Repeated Measures||The difference in adjusted means was calculated as Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W in the ITT Population.|Three hypotheses were tested in order for each faricimab arm (Q8W or PTI) separately against the aflibercept arm using a graph-based testing procedure. The analysis presented here is for the superiority of Arm A: Faricimab 6 mg Q8W compared with Arm C: Aflibercept 2 mg Q8W in the ITT Population.||3.2|-0.1|0.0361
72438208|NCT03622593|144389857|SUPERIORITY||Adjusted mean difference|0.5|STANDARD_ERROR_OF_MEAN|0.73||0.493|TWO_SIDED|97.5|-1.1|2.1||Tested at an overall significance level of α = 0.0248.|Mixed Model for Repeated Measures||The difference in adjusted means was calculated as Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W in the ITT Population.|Three hypotheses were tested in order for each faricimab arm (Q8W or PTI) separately against the aflibercept arm using a graph-based testing procedure. The analysis presented here is for the superiority of Arm B: Faricimab 6 mg PTI compared with Arm C: Aflibercept 2 mg Q8W in the ITT Population.||2.1|-1.1|0.4930
72438209|NCT03622593|144389858|NON_INFERIORITY|If the lower bound of the two-sided 97.52% confidence interval for the difference in CMH weighted percentages of participants for the faricimab Q8W and the active comparator (aflibercept Q8W) arms was greater than -10%, then faricimab Q8W was considered non-inferior to aflibercept.|Difference in CMH Weighted Percentage|-2.6|||||TWO_SIDED|97.5|-12.6|7.4||||||This analysis is for the non-inferiority of Arm A: Faricimab 6 mg Q8W compared with Arm C: Aflibercept 2 mg Q8W in the ITT Population.||7.4|-12.6|
72438210|NCT03622593|144389858|NON_INFERIORITY|If the lower bound of the two-sided 97.52% confidence interval for the difference in CMH weighted percentages of participants for the faricimab PTI and the active comparator (aflibercept Q8W) arms was greater than -10%, then faricimab PTI was considered non-inferior to aflibercept.|Difference in CMH Weighted Percentage|-3.5|||||TWO_SIDED|97.5|-13.4|6.3||||||This analysis is for the non-inferiority of Arm B: Faricimab 6 mg PTI compared with Arm C: Aflibercept 2 mg Q8W in the ITT Population.||6.3|-13.4|
72558742|NCT00128219|144647451|SUPERIORITY_OR_OTHER||Vaccine Efficacy, VE=1-RR=1-exp(ß)|36.0||||0.089||95.0|-7.0|61.0||Significance was set at .05 without adjustment for multiplicity. Exchangeable correlation structure and GEE were used for repeated measures.|Binomial regression, log-linear link|The Wald test of treatment effect was used to test no difference in proportion of GBS III pos. by arm against a 2-sided alternative of a difference.|Estimate of vaccine efficacy and 95% CI were obtained by transforming the estimate of log relative risk for treatment effect and the robust Wald CI in the log-linear binomial regression model fit to the proportion of vaginal type III GBS swabs.|The proportion of vaginal swabs that were GBS III culture positive was estimated from a GEE model fit with binomial family, log-link, and exchangeable correlation. Point and robust interval estimates for vaccine efficacy, were obtained by transforming those for treatment effect in this model, and used to test the hypothesis of no efficacy.||61|-7|0.089
72618843|NCT06097273|144768198|NON_INFERIORITY|The noninferiority in SCR in the Cohort B1 group compared with that of Cohort B2 group was demonstrated if the lower bound of the 97.5% CI of the SCR difference was \>-10%.|Percentage Difference|8.6|||||TWO_SIDED|97.5|5.6|11.6||||||Percentage Difference (Cohort B1 vs Cohort B2) for Victoria-lineage Antibody||11.6|5.6|
72385730|NCT01904058|144278940|SUPERIORITY_OR_OTHER||Least squares mean difference|-3.99||||0.438|TWO_SIDED|95.0|-14.2|6.23||p-value (LUM001 LS Mean = Placebo LS Mean).|ANCOVA|||The difference between treatment groups in change from Baseline to Week 13/ET in ItchRO weekly sum score was evaluated by ANCOVA using a GLM. The model included terms for treatment group, ALP level (strata), treatment group by ALP level interaction, and Baseline ItchRO weekly sum score as a covariate. Least squares mean change from Baseline to Week 13/ET, along with 95% confidence interval for the mean, were presented.||6.23|-14.20|0.4380
72385731|NCT04041375|144278962|SUPERIORITY|Treatment effect was modeled via multilevel linear regression with random intercepts for participants. Outcome was regressed on dummy coded categorical indicators of study arm (usual care reference), time point (baseline reference), and arm x time point interaction. Test of the arm x time interaction terms were used to assess treatment effects at months 3 and 6. Models conditioned on race, education, and income as specified a priori.|Interaction Term|-0.09||||0.42|TWO_SIDED|||||alpha = 0.05|Mixed Models Analysis|||Total Score - Treatment Effect - Month 3||||0.42
72385732|NCT04041375|144278962|SUPERIORITY|Treatment effect was modeled via multilevel linear regression with random intercepts for participants. Outcome was regressed on dummy coded categorical indicators of study arm (usual care reference), time point (baseline reference), and arm x time point interaction. Test of the arm x time interaction terms were used to assess treatment effects at months 3 and 6. Models conditioned on race, education, and income as specified a priori.|Interaction Term|-0.13||||0.32|TWO_SIDED|||||alpha = 0.05|Mixed Models Analysis|||Emotional Burden Subscale - Treatment Effect - Month 3||||0.32
72385733|NCT04041375|144278962|SUPERIORITY|Treatment effect was modeled via multilevel linear regression with random intercepts for participants. Outcome was regressed on dummy coded categorical indicators of study arm (usual care reference), time point (baseline reference), and arm x time point interaction. Test of the arm x time interaction terms were used to assess treatment effects at months 3 and 6. Models conditioned on race, education, and income as specified a priori.|Interaction Term|-0.13||||0.36|TWO_SIDED|||||alpha = 0.05|Mixed Models Analysis|||Physician-Related Distress Subscale - Treatment Effect - Month 3||||0.36
72385734|NCT04041375|144278962|SUPERIORITY|Treatment effect was modeled via multilevel linear regression with random intercepts for participants. Outcome was regressed on dummy coded categorical indicators of study arm (usual care reference), time point (baseline reference), and arm x time point interaction. Test of the arm x time interaction terms were used to assess treatment effects at months 3 and 6. Models conditioned on race, education, and income as specified a priori.|Interaction Term|-0.17||||0.23|TWO_SIDED|||||alpha = 0.05|Mixed Models Analysis|||Regimen-Related Distress Subscale - Treatment Effect - Month 3||||0.23
72385735|NCT04041375|144278962|SUPERIORITY|Treatment effect was modeled via multilevel linear regression model with random intercepts for participants. Outcome was regressed on dummy coded categorical indicators of study arm (usual care reference), time point (baseline reference), and arm x time point interaction. Test of the arm x time interaction terms were used to assess treatment effects at months 3 and 6. Models conditioned on race, education, and income as specified a priori.|Interaction Term|0.18||||0.26|TWO_SIDED|||||alpha = 0.05|Mixed Models Analysis|||Interpersonal Distress Subscale - Treatment Effect - Month 3||||0.26
72385736|NCT04041375|144278962|SUPERIORITY|Treatment effect was modeled via multilevel linear regression with random intercepts for participants. Outcome was regressed on dummy coded categorical indicators of study arm (usual care reference), time point (baseline reference), and arm x time point interaction. Test of the arm x time interaction terms were used to assess treatment effects at months 3 and 6. Models conditioned on race, education, and income as specified a priori.|Treatment Effect|0.007||||0.95|TWO_SIDED|||||alpha = 0.05|Mixed Models Analysis|||Total Score - Treatment Effect - Month 6||||0.95
72385737|NCT04041375|144278962|SUPERIORITY|Treatment effect was modeled via multilevel linear regression with random intercepts for participants. Outcome was regressed on dummy coded categorical indicators of study arm (usual care reference), time point (baseline reference), and arm x time point interaction. Test of the arm x time interaction terms were used to assess treatment effects at months 3 and 6. Models conditioned on race, education, and income as specified a priori.|Interaction Term|-0.01||||0.92|TWO_SIDED|||||alpha = 0.05|Mixed Models Analysis|||Emotional Burden Subscale - Treatment Effect - Month 6||||0.92
72385738|NCT04041375|144278962|SUPERIORITY|Treatment effect was modeled via multilevel linear regression with random intercepts for participants. Outcome was regressed on dummy coded categorical indicators of study arm (usual care reference), time point (baseline reference), and arm x time point interaction. Test of the arm x time interaction terms were used to assess treatment effects at months 3 and 6. Models conditioned on race, education, and income as specified a priori.|Interaction Term|-0.07||||0.59|TWO_SIDED|||||alpha = 0.05|Mixed Models Analysis|||Physician-Related Distress Subscale - Treatment Effect - Month 6||||0.59
72618844|NCT06097273|144768198|SUPERIORITY|The superiority in SCR in the Cohort B1 group compared with that of Cohort B2 group was demonstrated if the lower bound of the 95% CI of the SCR difference was \>0%.|Percentage Difference|2.7|||||TWO_SIDED|95.0|0.6|4.7||||||Percentage Difference (Cohort B1 vs Cohort B2) for Yamagata-lineage Antibody||4.7|0.6|
72385739|NCT04041375|144278962|SUPERIORITY|Treatment effect was modeled via multilevel linear regression with random intercepts for participants. Outcome was regressed on dummy coded categorical indicators of study arm (usual care reference), time point (baseline reference), and arm x time point interaction. Test of the arm x time interaction terms were used to assess treatment effects at months 3 and 6. Models conditioned on race, education, and income as specified a priori.|Interaction Term|-0.08||||0.54|TWO_SIDED|||||alpha = 0.05|Interaction Term|||Regimen-Related Distress Subscale - Treatment Effect - Month 6||||0.54
72385740|NCT04041375|144278962|SUPERIORITY|Treatment effect was modeled via multilevel linear regression with random intercepts for participants. Outcome was regressed on dummy coded categorical indicators of study arm (usual care reference), time point (baseline reference), and arm x time point interaction. Test of the arm x time interaction terms were used to assess treatment effects at months 3 and 6. Models conditioned on race, education, and income as specified a priori.|Interaction Term|0.3||||0.05|TWO_SIDED|||||alpha = 0.05|Mixed Models Analysis|||Interpersonal Distress Subscale - Treatment Effect - Month 6||||0.05
72438211|NCT03622593|144389858|SUPERIORITY||Difference in CMH Weighted Percentage|-5.4||||0.3009|TWO_SIDED|97.5|-16.9|6.1||Tested at an overall significance level of α = 0.0248.|Cochran-Mantel-Haenszel|||This analysis is for the superiority of Arm A: Faricimab 6 mg Q8W compared with Arm C: Aflibercept 2 mg Q8W in the Treatment-Naive Population.||6.1|-16.9|0.3009
72438212|NCT03622593|144389858|SUPERIORITY||Difference in CMH Weighted Percentage|-6.9||||0.1735|TWO_SIDED|97.5|-18.3|4.4||Tested at an overall significance level of α = 0.0248.|Cochran-Mantel-Haenszel|||This analysis is for the superiority of Arm B: Faricimab 6 mg PTI compared with Arm C: Aflibercept 2 mg Q8W in the Treatment-Naive Population.||4.4|-18.3|0.1735
72438213|NCT03622593|144389858|SUPERIORITY||Difference in CMH Weighted Percentage|-2.6||||0.5757|TWO_SIDED|97.5|-12.6|7.4||Tested at an overall significance level of α = 0.0248.|Cochran-Mantel-Haenszel|||This analysis is for the superiority of Arm A: Faricimab 6 mg Q8W compared with Arm C: Aflibercept 2 mg Q8W in the ITT Population.||7.4|-12.6|0.5757
72438214|NCT03622593|144389858|SUPERIORITY||Difference in CMH Weighted Percentage|-3.5||||0.4293|TWO_SIDED|97.5|-13.4|6.3||Tested at an overall significance level of α = 0.0248.|Cochran-Mantel-Haenszel|||This analysis is for the superiority of Arm B: Faricimab 6 mg PTI compared with Arm C: Aflibercept 2 mg Q8W in the ITT Population.||6.3|-13.4|0.4293
72438215|NCT03622593|144389861|OTHER||Difference in CMH Weighted Percentage|3.5|||||TWO_SIDED|95.0|-4.0|11.1||||||This is the difference in percentage of participants gaining ≥15 letters in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W.||11.1|-4.0|
72438216|NCT03622593|144389861|OTHER||Difference in CMH Weighted Percentage|-2.0|||||TWO_SIDED|95.0|-9.1|5.2||||||This is the difference in percentage of participants gaining ≥15 letters in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W.||5.2|-9.1|
72438217|NCT03622593|144389861|OTHER||Difference in CMH Weighted Percentage|5.4|||||TWO_SIDED|95.0|-2.5|13.4||||||This is the difference in percentage of participants gaining ≥10 letters in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W.||13.4|-2.5|
72438218|NCT03622593|144389861|OTHER||Difference in CMH Weighted Percentage|-1.1|||||TWO_SIDED|95.0|-8.9|6.8||||||This is the difference in percentage of participants gaining ≥10 letters in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W.||6.8|-8.9|
72438219|NCT03622593|144389861|OTHER||Difference in CMH Weighted Percentage|3.8|||||TWO_SIDED|95.0|-2.7|10.3||||||This is the difference in percentage of participants gaining ≥5 letters in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W.||10.3|-2.7|
72438220|NCT03622593|144389861|OTHER||Difference in CMH Weighted Percentage|-0.7|||||TWO_SIDED|95.0|-7.3|5.9||||||This is the difference in percentage of participants gaining ≥5 letters in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W.||5.9|-7.3|
72438221|NCT03622593|144389861|OTHER||Difference in CMH Weighted Percentage|0.7|||||TWO_SIDED|95.0|-3.8|5.2||||||This is the difference in percentage of participants gaining ≥0 letters in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W.||5.2|-3.8|
72438222|NCT03622593|144389861|OTHER||Difference in CMH Weighted Percentage|-0.3|||||TWO_SIDED|95.0|-4.9|4.2||||||This is the difference in percentage of participants gaining ≥0 letters in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W.||4.2|-4.9|
72438223|NCT03622593|144389866|OTHER||Difference in CMH Weighted Percentage|0.2|||||TWO_SIDED|95.0|-8.5|8.9||||||This is the difference in percentage of participants gaining ≥15 letters in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W.||8.9|-8.5|
72438224|NCT03622593|144389866|OTHER||Difference in CMH Weighted Percentage|-3.5|||||TWO_SIDED|95.0|-11.8|4.8||||||This is the difference in percentage of participants gaining ≥15 letters in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W.||4.8|-11.8|
72438225|NCT03622593|144389866|OTHER||Difference in CMH Weighted Percentage|2.2|||||TWO_SIDED|95.0|-6.9|11.4||||||This is the difference in percentage of participants gaining ≥10 letters in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W.||11.4|-6.9|
72438226|NCT03622593|144389866|OTHER||Difference in CMH Weighted Percentage|-0.8|||||TWO_SIDED|95.0|-9.8|8.1||||||This is the difference in percentage of participants gaining ≥10 letters in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W.||8.1|-9.8|
72438227|NCT03622593|144389866|OTHER||Difference in CMH Weighted Percentage|1.2|||||TWO_SIDED|95.0|-6.2|8.5||||||This is the difference in percentage of participants gaining ≥5 letters in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W.||8.5|-6.2|
72438228|NCT03622593|144389866|OTHER||Difference in CMH Weighted Percentage|-1.1|||||TWO_SIDED|95.0|-8.3|6.2||||||This is the difference in percentage of participants gaining ≥5 letters in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W.||6.2|-8.3|
72438229|NCT03622593|144389866|OTHER||Difference in CMH Weighted Percentage|1.2|||||TWO_SIDED|95.0|-3.8|6.2||||||This is the difference in percentage of participants gaining ≥0 letters in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W.||6.2|-3.8|
72438230|NCT03622593|144389866|OTHER||Difference in CMH Weighted Percentage|0.2|||||TWO_SIDED|95.0|-4.8|5.2||||||This is the difference in percentage of participants gaining ≥0 letters in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W.||5.2|-4.8|
72438231|NCT03622593|144389871|OTHER||Difference in CMH Weighted Percentage|0.3|||||TWO_SIDED|95.0|-1.6|2.1||||||This is the difference in percentage of participants avoiding a loss of ≥15 letters in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W.||2.1|-1.6|
72438232|NCT03622593|144389871|OTHER||Difference in CMH Weighted Percentage|0.0|||||TWO_SIDED|95.0|-1.8|1.9||||||This is the difference in percentage of participants avoiding a loss of ≥15 letters in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W.||1.9|-1.8|
72438233|NCT03622593|144389871|OTHER||Difference in CMH Weighted Percentage|-0.1|||||TWO_SIDED|95.0|-2.3|2.1||||||This is the difference in percentage of participants avoiding a loss of ≥10 letters in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W.||2.1|-2.3|
72438234|NCT03622593|144389871|OTHER||Difference in CMH Weighted Percentage|-0.3|||||TWO_SIDED|95.0|-2.4|1.9||||||This is the difference in percentage of participants avoiding a loss of ≥10 letters in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W.||1.9|-2.4|
72438235|NCT03622593|144389871|OTHER||Difference in CMH Weighted Percentage|1.3|||||TWO_SIDED|95.0|-1.9|4.5||||||This is the difference in percentage of participants avoiding a loss of ≥5 letters in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W.||4.5|-1.9|
72438236|NCT03622593|144389871|OTHER||Difference in CMH Weighted Percentage|1.6|||||TWO_SIDED|95.0|-1.5|4.6||||||This is the difference in percentage of participants avoiding a loss of ≥5 letters in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W.||4.6|-1.5|
72438237|NCT03622593|144389875|OTHER||Difference in CMH Weighted Percentage|0.0|||||TWO_SIDED|95.0|-2.3|2.2||||||This is the difference in percentage of participants avoiding a loss of ≥15 letters in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W.||2.2|-2.3|
72438238|NCT03622593|144389875|OTHER||Difference in CMH Weighted Percentage|0.1|||||TWO_SIDED|95.0|-2.0|2.2||||||This is the difference in percentage of participants avoiding a loss of ≥15 letters in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W.||2.2|-2.0|
72438239|NCT03622593|144389875|OTHER||Difference in CMH Weighted Percentage|0.0|||||TWO_SIDED|95.0|-2.7|2.6||||||This is the difference in percentage of participants avoiding a loss of ≥10 letters in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W.||2.6|-2.7|
72495211|NCT02475655|144519398|SUPERIORITY||Mean Difference (Net)|-0.7||||0.54|TWO_SIDED|90.0|-2.59|1.19||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in inflammatory monocytes (CD14+CD16+) from Entry to Week 12.||1.19|-2.59|0.54
72495212|NCT02475655|144519399|SUPERIORITY||Mean Difference (Net)|-6.02||||0.1|TWO_SIDED|90.0|-12.0|-0.06||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in inflammatory monocytes (CD14+CD16+) expressing CD163+ from Entry to Week 5.||-0.06|-12.0|0.10
72495213|NCT02475655|144519399|SUPERIORITY||Mean Difference (Net)|-6.39||||0.026|TWO_SIDED|90.0|-11.1|-1.73||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in inflammatory monocytes (CD14+CD16+) expressing CD163+ from Entry to Week 12.||-1.73|-11.1|0.026
72495214|NCT02475655|144519400|SUPERIORITY||Mean Difference (Net)|0.28||||0.95|TWO_SIDED|90.0|-7.26|7.82||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in inflammatory monocytes (CD14+CD16+) expressing CCR2+ from Entry to Week 5.||7.82|-7.26|0.95
72495215|NCT02475655|144519400|SUPERIORITY||Mean Difference (Net)|-4.1||||0.43|TWO_SIDED|90.0|-12.6|4.45||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in inflammatory monocytes (CD14+CD16+) expressing CCR2+ from Entry to Week 12.||4.45|-12.6|0.43
72495216|NCT02475655|144519401|SUPERIORITY||Mean Difference (Net)|1.23||||0.74|TWO_SIDED|90.0|-5.08|7.54||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in inflammatory monocytes (CD14+CD16+) expressing CX3CR1+ from Entry to Week 5.||7.54|-5.08|0.74
72618845|NCT06097273|144768198|NON_INFERIORITY|The noninferiority in SCR in the Cohort B1 group compared with that of Cohort B2 group was demonstrated if the lower bound of the 97.5% CI of the SCR difference was \>-10%.|Percentage Difference|2.7|||||TWO_SIDED|97.5|0.3|5.0||||||Percentage Difference (Cohort B1 vs Cohort B2) for Yamagata-lineage Antibody||5.0|0.3|
72438240|NCT03622593|144389875|OTHER||Difference in CMH Weighted Percentage|-0.3|||||TWO_SIDED|95.0|-2.9|2.3||||||This is the difference in percentage of participants avoiding a loss of ≥10 letters in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W.||2.3|-2.9|
72438241|NCT03622593|144389875|OTHER||Difference in CMH Weighted Percentage|1.3|||||TWO_SIDED|95.0|-2.0|4.7||||||This is the difference in percentage of participants avoiding a loss of ≥5 letters in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W.||4.7|-2.0|
72438242|NCT03622593|144389875|OTHER||Difference in CMH Weighted Percentage|1.2|||||TWO_SIDED|95.0|-2.1|4.4||||||This is the difference in percentage of participants avoiding a loss of ≥5 letters in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W.||4.4|-2.1|
72438243|NCT03622593|144389879|OTHER||Difference in CMH Weighted Percentage|4.8|||||TWO_SIDED|95.0|-3.1|12.7||||||This is the difference in percentage of participants in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W for the ITT Population.||12.7|-3.1|
72438244|NCT03622593|144389879|OTHER||Difference in CMH Weighted Percentage|-1.3|||||TWO_SIDED|95.0|-8.8|6.2||||||This is the difference in percentage of participants in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W for the ITT Population.||6.2|-8.8|
72438245|NCT03622593|144389879|OTHER||Difference in CMH Weighted Percentage|2.6|||||TWO_SIDED|95.0|-6.5|11.6||||||This is the difference in percentage of participants in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W for the Treatment-Naive Population.||11.6|-6.5|
72438246|NCT03622593|144389879|OTHER||Difference in CMH Weighted Percentage|-1.3|||||TWO_SIDED|95.0|-10.0|7.4||||||This is the difference in percentage of participants in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W for the Treatment-Naive Population.||7.4|-10.0|
72438247|NCT03622593|144389882|OTHER||Difference in CMH Weighted Percentage|4.7|||||TWO_SIDED|95.0|-2.4|11.8||||||This is the difference in percentage of participants in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W for the ITT Population.||11.8|-2.4|
72495217|NCT02475655|144519401|SUPERIORITY||Mean Difference (Net)|3.76||||0.42|TWO_SIDED|90.0|-3.94|11.5||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in inflammatory monocytes (CD14+CD16+) expressing CX3CR1+ from Entry to Week 12.||11.5|-3.94|0.42
72495218|NCT02475655|144519402|SUPERIORITY||Mean Difference (Net)|-0.63||||0.66|TWO_SIDED|90.0|-2.99|1.73||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in patrolling monocytes (CD14dimCD16+) from Entry to Week 5.||1.73|-2.99|0.66
72495219|NCT02475655|144519402|SUPERIORITY||Mean Difference (Net)|-1.56||||0.27|TWO_SIDED|90.0|-3.93|0.8||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in patrolling monocytes (CD14dimCD16+) from Entry to Week 12.||0.80|-3.93|0.27
72495220|NCT02475655|144519403|SUPERIORITY||Mean Difference (Net)|-7.1||||0.013|TWO_SIDED|90.0|-11.7|-2.46||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in patrolling monocytes (CD14dimCD16+) expressing CD163+ from Entry to Week 5.||-2.46|-11.7|0.013
72495221|NCT02475655|144519403|SUPERIORITY||Mean Difference (Net)|-1.49||||0.7|TWO_SIDED|90.0|-8.06|5.07||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in patrolling monocytes (CD14dimCD16+) expressing CD163+ from Entry to Week 12.||5.07|-8.06|0.70
72495222|NCT02475655|144519404|SUPERIORITY||Mean Difference (Net)|0.01||||0.79|TWO_SIDED|90.0|-0.05|0.07||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in patrolling monocytes (CD14dimCD16+) expressing CCR2+ from Entry to Week 5.||0.07|-0.05|0.79
72495223|NCT02475655|144519404|SUPERIORITY||Mean Difference (Net)|0.01||||0.91|TWO_SIDED|90.0|-0.07|0.08||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in patrolling monocytes (CD14dimCD16+) expressing CCR2+ from Entry to Week 12.||0.08|-0.07|0.91
72385741|NCT04041375|144278963|SUPERIORITY|Treatment effect was modeled via multilevel linear regression with random intercepts for participants. Outcome was regressed on dummy coded categorical indicators of study arm (usual care reference), time point (baseline reference), and arm x time point interaction. Test of the arm x time interaction terms were used to assess treatment effects at months 3 and 6. Models conditioned on race, education, and income as specified a priori.|Interaction Term|0.58||||0.03|TWO_SIDED|||||alpha = 0.05|Mixed Models Analysis|||General Diet - Treatment Effect - Month 3||||0.03
72385742|NCT04041375|144278963|SUPERIORITY|Treatment effect was modeled via multilevel linear regression with random intercepts for participants. Outcome was regressed on dummy coded categorical indicators of study arm (usual care reference), time point (baseline reference), and arm x time point interaction. Test of the arm x time interaction terms were used to assess treatment effects at months 3 and 6. Models conditioned on race, education, and income as specified a priori.|Interaction Term|0.07||||0.83|TWO_SIDED||||||Mixed Models Analysis|||Specific Diet (Fruits and Vegetables) - Treatment Effect - Month 3||||0.83
72385743|NCT04041375|144278963|SUPERIORITY|Treatment effect was modeled via multilevel linear regression with random intercepts for participants. Outcome was regressed on dummy coded categorical indicators of study arm (usual care reference), time point (baseline reference), and arm x time point interaction. Test of the arm x time interaction terms were used to assess treatment effects at months 3 and 6. Models conditioned on race, education, and income as specified a priori.|Interaction Term|-0.44||||0.12|TWO_SIDED|||||alpha = 0.05|Mixed Models Analysis|||Specific Diet (Fat) - Treatment Effect - Month 3||||0.12
72385744|NCT04041375|144278963|SUPERIORITY|Treatment effect was modeled via multilevel linear regression with random intercepts for participants. Outcome was regressed on dummy coded categorical indicators of study arm (usual care reference), time point (baseline reference), and arm x time point interaction. Test of the arm x time interaction terms were used to assess treatment effects at months 3 and 6. Models conditioned on race, education, and income as specified a priori.|Interaction Term|0.39||||0.17|TWO_SIDED|||||alpha = 0.05|Mixed Models Analysis|||Physical Activity - Treatment Effect - Month 3||||0.17
72438248|NCT03622593|144389882|OTHER||Difference in CMH Weighted Percentage|2.8|||||TWO_SIDED|95.0|-4.1|9.8||||||This is the difference in percentage of participants in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W for the ITT Population.||9.8|-4.1|
72438249|NCT03622593|144389882|OTHER||Difference in CMH Weighted Percentage|1.5|||||TWO_SIDED|95.0|-6.5|9.4||||||This is the difference in percentage of participants in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W for the Treatment-Naive Population.||9.4|-6.5|
72438250|NCT03622593|144389882|OTHER||Difference in CMH Weighted Percentage|1.7|||||TWO_SIDED|95.0|-6.0|9.3||||||This is the difference in percentage of participants in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W for the Treatment-Naive Population.||9.3|-6.0|
72438251|NCT03622593|144389885|OTHER||Difference in CMH Weighted Percentage|0.1|||||TWO_SIDED|95.0|-1.4|1.5||||||This is the difference in percentage of participants in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W for the ITT Population.||1.5|-1.4|
72495224|NCT02475655|144519405|SUPERIORITY||Mean Difference (Net)|-2.85||||0.43|TWO_SIDED|90.0|-8.82|3.12||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in patrolling monocytes (CD14dimCD16+) expressing CX3CR1+ from Entry to Week 5.||3.12|-8.82|0.43
72495225|NCT02475655|144519405|SUPERIORITY||Mean Difference (Net)|0.03||||0.99|TWO_SIDED|90.0|-6.53|6.6||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in patrolling monocytes (CD14dimCD16+) expressing CX3CR1+ from Entry to Week 12.||6.60|-6.53|0.99
72495226|NCT02475655|144519406|SUPERIORITY||Median Difference (Net)|1.88||||0.007|TWO_SIDED|90.0|1.29|2.73||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib geometric mean minus No Study Treatment geometric mean. All values were log10 transformed prior to calculating change and conducting analyses and back transformed for presentation.|Null hypothesis: There is no difference between the two arms in the fold change in Cellular HIV-1 DNA from entry to Week 5.||2.73|1.29|0.007
72495227|NCT02475655|144519406|SUPERIORITY||Mean Difference (Net)|1.31||||0.23|TWO_SIDED|90.0|0.9|1.9||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib geometric mean minus No Study Treatment geometric mean. All values were log10 transformed prior to calculating change and conducting analyses and back transformed for presentation.|Null hypothesis: There is no difference between the two arms in the fold change in Cellular HIV-1 DNA from entry to Week 12.||1.90|0.90|0.23
72495228|NCT02475655|144519407|SUPERIORITY||Mean Difference (Net)|1.22||||0.32|TWO_SIDED|90.0|0.87|1.72||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib geometric mean minus No Study Treatment geometric mean. All values were log10 transformed prior to calculating change and conducting analyses and back transformed for presentation.|Null hypothesis: There is no difference between the two arms in the fold change in cellular HIV-1 total RNA from entry to Week 5.||1.72|0.87|0.32
72438252|NCT03622593|144389885|OTHER||Difference in CMH Weighted Percentage|-0.7|||||TWO_SIDED|95.0|-1.6|0.2||||||This is the difference in percentage of participants in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W for the ITT Population.||0.2|-1.6|
72438253|NCT03622593|144389885|OTHER||Difference in CMH Weighted Percentage|0.5|||||TWO_SIDED|95.0|-1.1|2.1||||||This is the difference in percentage of participants in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W for the Treatment-Naive Population.||2.1|-1.1|
72438254|NCT03622593|144389885|OTHER||Difference in CMH Weighted Percentage|-0.5|||||TWO_SIDED|95.0|-1.4|0.4||||||This is the difference in percentage of participants in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W for the Treatment-Naive Population.||0.4|-1.4|
72438255|NCT03622593|144389894|OTHER||Difference in CMH Weighted Percentage|0.4|||||TWO_SIDED|95.0|-1.0|1.8||||||This is the difference in percentage of participants in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W for the ITT Population.||1.8|-1.0|
72495229|NCT02475655|144519407|SUPERIORITY||Mean Difference (Net)|1.03||||0.91|TWO_SIDED|90.0|0.68|1.56||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib geometric mean minus No Study Treatment geometric mean. All values were log10 transformed prior to calculating change and conducting analyses and back transformed for presentation.|Null hypothesis: There is no difference between the two arms in the fold change in cellular HIV-1 total RNA from entry to Week 12.||1.56|0.68|0.91
72495230|NCT02475655|144519408|SUPERIORITY|||||||0.4||||||Not adjusted for multiple comparisons. Two-sided 10% alpha.|Fisher Exact|Fisher's Exact Mid P-Value||Null hypothesis: There is no difference between the two arms in the percentage of participants with detectable CMV at any on-treatment time point (ever shedding at weeks 1, 2, 4, or 5).||||0.40
72495231|NCT02475655|144519408|SUPERIORITY|||||||0.87||||||Not adjusted for multiple comparisons. Two-sided 10% alpha.|Fisher Exact|Fisher's Exact Mid P-Value||Null hypothesis: There is no difference between the two arms in the percentage of participants with detectable CMV at any post-treatment time point (ever shedding at weeks 10 or 12).||||0.87
72495232|NCT02475655|144519412|SUPERIORITY||Mean Difference (Net)|0.53||||0.4|TWO_SIDED|90.0|0.15|1.88||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib geometric mean minus No Study Treatment geometric mean. All values were log10 transformed prior to calculating change and conducting analyses and back transformed for presentation.|Null hypothesis: There is no difference between the two arms in the fold change in Integrated DNA from entry to Week 5.||1.88|0.15|0.40
72438256|NCT03622593|144389894|OTHER||Difference in CMH Weighted Percentage|0.5|||||TWO_SIDED|95.0|-1.0|2.0||||||This is the difference in percentage of participants in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W for the ITT Population.||2.0|-1.0|
72438257|NCT03622593|144389894|OTHER||Difference in CMH Weighted Percentage|0.6|||||TWO_SIDED|95.0|-0.6|1.8||||||This is the difference in percentage of participants in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W for the Treatment-Naive Population.||1.8|-0.6|
72438258|NCT03622593|144389894|OTHER||Difference in CMH Weighted Percentage|1.2|||||TWO_SIDED|95.0|-0.4|2.8||||||This is the difference in percentage of participants in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W for the Treatment-Naive Population.||2.8|-0.4|
72438259|NCT03622593|144389895|OTHER||Difference in CMH Weighted Percentage|0.0|||||TWO_SIDED|95.0|0.0|0.0||||||This is the difference in percentage of participants in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W for the ITT Population.||0.0|0.0|
72438260|NCT03622593|144389895|OTHER||Difference in CMH Weighted Percentage|0.0|||||TWO_SIDED|95.0|0.0|0.0||||||This is the difference in percentage of participants in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W for the ITT Population.||0.0|0.0|
72438261|NCT03622593|144389895|OTHER||Difference in CMH Weighted Percentage|0.0|||||TWO_SIDED|95.0|0.0|0.0||||||This is the difference in percentage of participants in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W for the Treatment-Naive Population.||0.0|0.0|
72495233|NCT02475655|144519412|SUPERIORITY||Mean Difference (Net)|0.92||||0.93|TWO_SIDED|90.0|0.2|4.34||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib geometric mean minus No Study Treatment geometric mean. All values were log10 transformed prior to calculating change and conducting analyses and back transformed for presentation.|Null hypothesis: There is no difference between the two arms in the fold change in Integrated DNA from entry to Week 12.||4.34|0.20|0.93
72495234|NCT03545906|144519414|SUPERIORITY||Mean Difference (Net)|1.0||||0.075|TWO_SIDED||||||t-test, 2 sided|||||||.075
72385745|NCT04041375|144278963|SUPERIORITY|Treatment effect was modeled via multilevel linear regression with random intercepts for participants. Outcome was regressed on dummy coded categorical indicators of study arm (usual care reference), time point (baseline reference), and arm x time point interaction. Test of the arm x time interaction terms were used to assess treatment effects at months 3 and 6. Models conditioned on race, education, and income as specified a priori.|Interaction Term|0.06||||0.85|TWO_SIDED|||||alpha = 0.05|Mixed Models Analysis|||Blood Glucose Testing - Treatment Effect - Month 3||||0.85
72385746|NCT04041375|144278963|SUPERIORITY|Treatment effect was modeled via multilevel linear regression with random intercepts for participants. Outcome was regressed on dummy coded categorical indicators of study arm (usual care reference), time point (baseline reference), and arm x time point interaction. Test of the arm x time interaction terms were used to assess treatment effects at months 3 and 6. Models conditioned on race, education, and income as specified a priori.|Interaction Term|0.02||||0.94|TWO_SIDED|||||alpha = 0.05|Mixed Models Analysis|||Foot Care - Treatment Effect - Month 3||||0.94
72385747|NCT04041375|144278963|SUPERIORITY|Treatment effect was modeled via multilevel linear regression with random intercepts for participants. Outcome was regressed on dummy coded categorical indicators of study arm (usual care reference), time point (baseline reference), and arm x time point interaction. Test of the arm x time interaction terms were used to assess treatment effects at months 3 and 6. Models conditioned on race, education, and income as specified a priori.|Interaction Term|0.19||||0.47|TWO_SIDED|||||alpha = 0.05|Mixed Models Analysis|||General Diet - Treatment Effect - Month 6||||0.47
72385748|NCT04041375|144278963|SUPERIORITY|Treatment effect was modeled via multilevel linear regression with random intercepts for participants. Outcome was regressed on dummy coded categorical indicators of study arm (usual care reference), time point (baseline reference), and arm x time point interaction. Test of the arm x time interaction terms were used to assess treatment effects at months 3 and 6. Models conditioned on race, education, and income as specified a priori.|Interaction Term|0.08||||0.82|TWO_SIDED|||||alpha = 0.05|Mixed Models Analysis|||Specific Diet (Fruits and Vegetables) - Treatment Effect - Month 6||||0.82
72385749|NCT04041375|144278963|SUPERIORITY|Treatment effect was modeled via multilevel linear regression with random intercepts for participants. Outcome was regressed on dummy coded categorical indicators of study arm (usual care reference), time point (baseline reference), and arm x time point interaction. Test of the arm x time interaction terms were used to assess treatment effects at months 3 and 6. Models conditioned on race, education, and income as specified a priori.|Interaction Term|-0.13||||0.66|TWO_SIDED|||||alpha = 0.05|Mixed Models Analysis|||Specific Diet (Fat) - Treatment Effect - Month 6||||0.66
72385750|NCT04041375|144278963|SUPERIORITY|Treatment effect was modeled via multilevel linear regression with random intercepts for participants. Outcome was regressed on dummy coded categorical indicators of study arm (usual care reference), time point (baseline reference), and arm x time point interaction. Test of the arm x time interaction terms were used to assess treatment effects at months 3 and 6. Models conditioned on race, education, and income as specified a priori.|Interaction Term|0.25||||0.38|TWO_SIDED|||||alpha = 0.05|Mixed Models Analysis|||Physical Activity - Treatment Effect - Month 6||||0.38
72385751|NCT04041375|144278963|SUPERIORITY|Treatment effect was modeled via multilevel linear regression with random intercepts for participants. Outcome was regressed on dummy coded categorical indicators of study arm (usual care reference), time point (baseline reference), and arm x time point interaction. Test of the arm x time interaction terms were used to assess treatment effects at months 3 and 6. Models conditioned on race, education, and income as specified a priori.|Interaction Term|-0.12||||0.68|TWO_SIDED|||||alpha = 0.05|Mixed Models Analysis|||Blood Glucose Testing - Treatment Effect - Month 6||||0.68
72385752|NCT04041375|144278963|SUPERIORITY|Treatment effect was modeled via multilevel linear regression with random intercepts for participants. Outcome was regressed on dummy coded categorical indicators of study arm (usual care reference), time point (baseline reference), and arm x time point interaction. Test of the arm x time interaction terms were used to assess treatment effects at months 3 and 6. Models conditioned on race, education, and income as specified a priori.|Interaction Term|0.26||||0.4|TWO_SIDED|||||alpha = 0.05|Mixed Models Analysis|||Foot Care - Treatment Effect - Month 6||||0.40
72385753|NCT04041375|144278965|SUPERIORITY|Treatment effect was modeled via multilevel linear regression with random intercepts for participants. Outcome was regressed on dummy coded categorical indicators of study arm (usual care reference), time point (baseline reference), and arm x time point interaction. Test of the arm x time interaction terms were used to assess treatment effects at months 3 and 6. Models conditioned on race, education, and income as specified a priori.|Interaction Term|0.06||||0.93|TWO_SIDED|||||alpha = 0.05|Mixed Models Analysis|||Treatment Effect - Month 3||||0.93
72385754|NCT04041375|144278965|SUPERIORITY|Treatment effect was modeled via multilevel linear regression with random intercepts for participants. Outcome was regressed on dummy coded categorical indicators of study arm (usual care reference), time point (baseline reference), and arm x time point interaction. Test of the arm x time interaction terms were used to assess treatment effects at months 3 and 6. Models conditioned on race, education, and income as specified a priori.|Interaction Term|0.63||||0.38|TWO_SIDED|||||alpha = 0.05|Mixed Models Analysis|||Treatment Effect - Month 6||||0.38
72495235|NCT03545906|144519415|SUPERIORITY||Mean Difference (Net)|1.3||||0.018|TWO_SIDED||||||t-test, 2 sided|||||||.018
72495236|NCT03545906|144519416|SUPERIORITY||Mean Difference (Net)|1.2||||0.039|TWO_SIDED||||||t-test, 2 sided|||||||.039
72495237|NCT03545906|144519417|SUPERIORITY||Mean Difference (Net)|0.7||||0.265|TWO_SIDED||||||t-test, 2 sided|||||||.265
72504747|NCT03114969|144540500|SUPERIORITY||Odds Ratio (OR)|4.855|||<|0.001|TWO_SIDED|95.0|2.339|10.08||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta+\[Relvar Ellipta+LAMA\] as comparator.|||10.080|2.339|<0.001
72495238|NCT03244033|144519461|SUPERIORITY||Odds Ratio (OR)|0.97||||0.91|TWO_SIDED|96.0|0.57|1.64|||Mixed Models Analysis|Adjusted for site (p\<.001) and for whether physician contextualized plan (AOR 2.14, p=.001), and random effects of physician and patient.||Logistic mixed effects regression modeling likelihood of red flag improved/resolved (vs. not) during outcome period with fixed effects of intervention, site, and whether contextual factor was incorporated into care plan, and random effects of patient and provider. Red flags may be clustered in patients; patients are clustered in providers.||1.64|.57|.91
72495239|NCT03244033|144519462|SUPERIORITY||Odds Ratio (OR)|2.09||||0.02|TWO_SIDED|95.0|1.13|3.86|||Mixed Models Analysis|Adjusted for site, source of red flag, visible/concealed recorder, and random effects of physician and patient.|OR\>1 indicates greater likelihood in intervention group vs. control.|Logistic mixed effects regression modeling likelihood of provider probing red flag (vs. not) during visit with fixed effects of intervention, site, \\whether red flag was select on pre-visit questionnaire, and whether audiorecorder was visible to provider, and random effects of patient and provider. Red flags may be clustered in patients; patients are clustered in providers.||3.86|1.13|0.02
72558743|NCT00128219|144647452|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.53||||0.256|TWO_SIDED|95.0|0.18|1.45||The a priori threshold for statistical significance for the analysis of secondary endpoints was set at .05 without adjustment for multiplicity.|Fisher Exact|Fisher's exact test was used to test no difference in proportion persistently colonized by arm against a two-sided alternative of a difference.|The OR was calculated from the 2x2 contingency table, and the 95% CI was obtained by inverting the two-sided 5% level Fisher's exact test. The GBS III-TT arm is in the numerator and Td arm in the denominator, so a value \<1 favors the GBS III-TT arm.|A two-sided 5% level Fisher's exact test was used to test the null hypothesis of no difference in proportion of participants who were vaginal type III GBS negative throughout the study between treatment arms. The two-sided 5% Fisher's exact test was inverted to obtain a 95% confidence interval for the odds ratio.||1.45|0.18|0.256
72618846|NCT06097273|144768199|SUPERIORITY|The superiority in seroresponse rate (SRR) in the Cohort A1 group compared with that of Cohort A2 group was demonstrated if the lower bound of the 95% CI of the SRR difference was \>0%.|Percentage Difference|12.8|||||TWO_SIDED|95.0|10.0|15.5||||||Percentage Difference (Cohort A1 vs Cohort A2) for SARS-CoV-2 Antibody||15.5|10.0|
72495240|NCT03244033|144519463|SUPERIORITY||Odds Ratio (OR)|2.67||||0.006|TWO_SIDED|95.0|1.32|5.41|||Mixed Models Analysis|Adjusted for site, source of factor, recorder visible/concealed, and random effects of physician and patient.|OR \> 1 indicates greater likelihood in intervention group vs. control.|Logistic mixed effects regression modeling likelihood of provider incorporating contextual factor into care plan (vs. not) at visit with fixed effects of intervention, site, whether red flag was select on pre-visit questionnaire, whether audiorecorder was visible to provider, whether factor was identified by provider probe, whether factor was revealed by patient, and random effects of patient and provider. Red flags may be clustered in patients; patients are clustered in providers.||5.41|1.32|.006
72495241|NCT03021642|144519476|SUPERIORITY_OR_OTHER_LEGACY||Geometric Least square (LS) mean ratio|98.68|||||TWO_SIDED|90.0|93.67|103.96||||||||103.96|93.67|
72495242|NCT03021642|144519477|SUPERIORITY_OR_OTHER_LEGACY||Geometric LS mean ratio|95.71|||||TWO_SIDED|90.0|88.43|103.59||||||||103.59|88.43|
72495243|NCT03021642|144519478|SUPERIORITY_OR_OTHER_LEGACY||Geometric LS mean ratio|96.88|||||TWO_SIDED|90.0|90.8|103.36||||||||103.36|90.8|
72495244|NCT03021642|144519479|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Net)|0.0||||0.8981|TWO_SIDED|90.0|-1.0|1.025|||Wilcoxon signed-rank test|||||1.025|-1.000|0.8981
72495245|NCT02474082|144519493|SUPERIORITY||Odds Ratio (OR)|16.61|||<|0.0001|TWO_SIDED|95.0|7.79|35.4|||Regression, Logistic|||||35.40|7.79|<.0001
72385755|NCT04041375|144278966|SUPERIORITY|Treatment effect was modeled via multilevel linear regression with random intercepts for participants. Outcome was regressed on dummy coded categorical indicators of study arm (usual care reference), time point (baseline reference), and arm x time point interaction. Test of the arm x time interaction terms were used to assess treatment effects at months 3 and 6. Models conditioned on race, education, and income as specified a priori.|Interaction Term|0.32||||0.66|TWO_SIDED|||||alpha = 0.05|Mixed Models Analysis|||Treatment Effect - Month 3||||0.66
72385756|NCT04041375|144278966|SUPERIORITY|Treatment effect was modeled via multilevel linear regression with random intercepts for participants. Outcome was regressed on dummy coded categorical indicators of study arm (usual care reference), time point (baseline reference), and arm x time point interaction. Test of the arm x time interaction terms were used to assess treatment effects at months 3 and 6. Models conditioned on race, education, and income as specified a priori.|Interaction Term|0.99||||0.18|TWO_SIDED|||||alpha = 0.05|Mixed Models Analysis|||Treatment Effect - Month 6||||0.18
72385757|NCT04041375|144278969|SUPERIORITY|Treatment effect was modeled via multilevel linear regression with random intercepts for participants. Outcome was regressed on dummy coded categorical indicators of study arm (usual care reference), time point (baseline reference), and arm x time point interaction. Test of the arm x time interaction terms were used to assess treatment effects at months 3 and 6. Models conditioned on race, education, and income as specified a priori.|Interaction Term|1.45||||0.38|TWO_SIDED|||||alpha = 0.05|Mixed Models Analysis|||Treatment Effect - Month 3||||0.38
72495246|NCT03175549|144519527|SUPERIORITY||Mean Difference (Final Values)|5.53|STANDARD_ERROR_OF_MEAN|10.1||0.36|TWO_SIDED|95.0|-10.22|29.38||A priori threshold for significance was 0.05.|Mixed Models Analysis||Standard error was calculated using bootstrap methods which is considered best for MEM.|||29.38|-10.22|0.36
72495247|NCT03175549|144519528|SUPERIORITY||Slope|-0.067|STANDARD_ERROR_OF_MEAN|0.03|<|0.025|TWO_SIDED||||||t-test, 2 sided|||Posted results show mean change in drinking for the drug group relative to placebo for each day of the 11 days of ad libidum drinking (Days 1-11) permitted during the 14 days (2 weeks) of medication.||||<0.025
72495248|NCT03175549|144519528|SUPERIORITY||Slope|-0.067|STANDARD_ERROR_OF_MEAN|0.03||0.025|TWO_SIDED||||||Mixed Models Analysis|473 daily observations within 43 individuals.|The apremilast group showed a significantly more rapid reduction in drinks per day relative to placebo.|||||0.025
72495249|NCT02435849|144519529|OTHER|testing the null hypothesis that ORR within 3 months is less than or equal to 20%|||||<|0.0001|||||||Clopper-Pearson|||||||<.0001
72495250|NCT02435849|144519531|OTHER|testing the null hypothesis that ORR with MRD negative within 3 months is less than or equal to 15%|||||<|0.0001|||||||Clopper-Pearson|||||||<.0001
72495251|NCT02435849|144519532|OTHER|testing the null hypothesis that ORR with MRD negative within 3 months is less than or equal to 15%|||||<|0.0001|||||||Clopper-Pearson|||||||<.0001
72385758|NCT04041375|144278969|SUPERIORITY|Treatment effect was modeled via multilevel linear regression with random intercepts for participants. Outcome was regressed on dummy coded categorical indicators of study arm (usual care reference), time point (baseline reference), and arm x time point interaction. Test of the arm x time interaction terms were used to assess treatment effects at months 3 and 6. Models conditioned on race, education, and income as specified a priori.|Interaction Term|1.64||||0.68|TWO_SIDED|||||alpha = 0.05|Mixed Models Analysis|||Treatment Effect - Month 6||||0.68
72618847|NCT06097273|144768199|NON_INFERIORITY|The noninferiority in SRR in the Cohort A1 group compared with that of Cohort A2 group was demonstrated if the lower bound of the 97.5% CI of the SRR difference was \>-10%.|Percentage Difference|12.8|||||TWO_SIDED|97.5|9.6|15.9||||||Percentage Difference (Cohort A1 vs Cohort A2) for SARS-CoV-2 Antibody||15.9|9.6|
72385759|NCT04041375|144278970|SUPERIORITY|Treatment effect was modeled via multilevel linear regression with random intercepts for participants. Outcome was regressed on dummy coded categorical indicators of study arm (usual care reference), time point (baseline reference), and arm x time point interaction. Test of the arm x time interaction terms were used to assess treatment effects at months 3 and 6. Models conditioned on race, education, and income as specified a priori.|Interaction Term|0.19||||0.74|TWO_SIDED|||||alpha = 0.05|Mixed Models Analysis|||Treatment Effect - Month 3||||0.74
72385760|NCT04041375|144278970|SUPERIORITY|Treatment effect was modeled via multilevel linear regression with random intercepts for participants. Outcome was regressed on dummy coded categorical indicators of study arm (usual care reference), time point (baseline reference), and arm x time point interaction. Test of the arm x time interaction terms were used to assess treatment effects at months 3 and 6. Models conditioned on race, education, and income as specified a priori.|Interaction Term|0.29||||0.62|TWO_SIDED|||||alpha = 0.05|Mixed Models Analysis|||Treatment Effect - Month 6||||0.62
72385761|NCT04041375|144278971|SUPERIORITY|Treatment effect was modeled via multilevel linear regression with random intercepts for participants. Outcome was regressed on dummy coded categorical indicators of study arm (usual care reference), time point (baseline reference), and arm x time point interaction. Test of the arm x time interaction terms were used to assess treatment effects at months 3 and 6. Models conditioned on race, education, and income as specified a priori.|Interaction Term|0.16||||0.72|TWO_SIDED|||||alpha = 0.05|Mixed Models Analysis|||Treatment Effect - Month 3||||0.72
72385762|NCT04041375|144278971|SUPERIORITY|Treatment effect was modeled via multilevel linear regression with random intercepts for participants. Outcome was regressed on dummy coded categorical indicators of study arm (usual care reference), time point (baseline reference), and arm x time point interaction. Test of the arm x time interaction terms were used to assess treatment effects at months 3 and 6. Models conditioned on race, education, and income as specified a priori.|Interaction Term|-0.24||||0.58|TWO_SIDED|||||alpha = 0.05|Mixed Models Analysis|||Treatment Effect - Month 6||||0.58
72385763|NCT04041375|144278972|SUPERIORITY|Treatment effect was modeled via multilevel linear regression with random intercepts for participants. Outcome was regressed on dummy coded categorical indicators of study arm (usual care reference), time point (baseline reference), and arm x time point interaction. Test of the arm x time interaction terms were used to assess treatment effects at months 3 and 6. Models conditioned on race, education, and income as specified a priori.|Interaction Term|0.36||||0.5|TWO_SIDED|||||alpha = 0.05|Mixed Models Analysis|||Treatment Effect - Month 3||||0.50
72385764|NCT04041375|144278972|SUPERIORITY|Treatment effect was modeled via multilevel linear regression with random intercepts for participants. Outcome was regressed on dummy coded categorical indicators of study arm (usual care reference), time point (baseline reference), and arm x time point interaction. Test of the arm x time interaction terms were used to assess treatment effects at months 3 and 6. Models conditioned on race, education, and income as specified a priori.|Interaction Term|0.72||||0.18|TWO_SIDED|||||alpha = 0.05|Mixed Models Analysis|||Treatment Effect - Month 6||||0.18
72385765|NCT01967342|144278981|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.268|STANDARD_ERROR_OF_MEAN|-0.193||0.165|TWO_SIDED||||||Mixed Models Analysis|||A piecewise linear growth model examined changes in BPI-Intensity within Usual Care between pre-treatment and 10-week post-treatment.||||.165
72385766|NCT01967342|144278981|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.245|STANDARD_ERROR_OF_MEAN|0.198||0.216|TWO_SIDED||||||Mixed Models Analysis|||A piecewise linear growth model examined changes in BPI-Intensity within Usual Care between post-treatment and 6-month follow-up.||||.216
72385767|NCT01967342|144278981|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.052|STANDARD_ERROR_OF_MEAN|0.189|<|0.001|TWO_SIDED||||||Mixed Models Analysis|||A piecewise linear growth model examined changes in BPI-Intensity within CBT group between the pre-treatment and 10-week post-treatment.||||< .001
72385768|NCT01967342|144278981|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.361|STANDARD_ERROR_OF_MEAN|0.199||0.07|TWO_SIDED||||||Mixed Models Analysis|||A piecewise linear growth model examined changes in BPI-Intensity within CBT group between the post-treatment and 6-month follow-up.||||.070
72385769|NCT01967342|144278981|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.823|STANDARD_ERROR_OF_MEAN|0.191|<|0.001|TWO_SIDED||||||Mixed Models Analysis|||A piecewise linear growth model examined changes in BPI-Intensity within Pain Ed group between the pre-treatment and 10-week post-treatment.||||< .001
72385770|NCT01967342|144278981|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.131|STANDARD_ERROR_OF_MEAN|0.203||0.519|TWO_SIDED||||||Mixed Models Analysis|||A piecewise linear growth model examined changes in BPI-Intensity within Pain Ed group between the post-treatment and 6-month follow-up.||||.519
72385771|NCT01967342|144278982|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.31|STANDARD_ERROR_OF_MEAN|0.247||0.196|TWO_SIDED|||||To control for multiple comparisons in secondary outcomes, a corrected alpha level was calculated using the Benjamini-Hochberg correction method. Smallest p-value compared to .025; Largest p-value compared to .050.|Mixed Models Analysis|||A piecewise linear growth model examined changes in BPI-Interference within Usual Care group between the pre-treatment and 10-week post-treatment.||||.196
72385772|NCT01967342|144278982|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.182|STANDARD_ERROR_OF_MEAN|0.239||0.447|TWO_SIDED|||||To control for multiple comparisons in secondary outcomes, a corrected alpha level was calculated using the Benjamini-Hochberg correction method. Smallest p-value compared to .025; Largest p-value compared to .050.|Mixed Models Analysis|||A piecewise linear growth model examined changes in BPI-Interference within Usual Care group between the post-treatment and 6-month follow-up.||||.447
72438262|NCT03622593|144389895|OTHER||Difference in CMH Weighted Percentage|0.0|||||TWO_SIDED|95.0|0.0|0.0||||||This is the difference in percentage of participants in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W for the Treatment-Naive Population.||0.0|0.0|
72618848|NCT06097273|144768199|SUPERIORITY|The superiority in SRR in the Cohort B1 group compared with that of Cohort B2 group was demonstrated if the lower bound of the 95% CI of the SRR difference was \>0%.|Percentage Difference|8.1|||||TWO_SIDED|95.0|5.5|10.6||||||Percentage Difference (Cohort B1 vs Cohort B2) for SARS-CoV-2 Antibody||10.6|5.5|
72385773|NCT01967342|144278982|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.643|STANDARD_ERROR_OF_MEAN|0.241|<|0.001|TWO_SIDED|||||To control for multiple comparisons in secondary outcomes, a corrected alpha level was calculated using the Benjamini-Hochberg correction method. Smallest p-value compared to .025; Largest p-value compared to .050.|Mixed Models Analysis|||A piecewise linear growth model examined changes in BPI-Interference within CBT for Pain group between the pre-treatment and 10-week post-treatment.||||<.001
72385774|NCT01967342|144278982|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.548|STANDARD_ERROR_OF_MEAN|0.237||0.021|TWO_SIDED|||||To control for multiple comparisons in secondary outcomes, a corrected alpha level was calculated using the Benjamini-Hochberg correction method. Smallest p-value compared to .025; Largest p-value compared to .050.|Mixed Models Analysis|||A piecewise linear growth model examined changes in BPI-Interference within CBT for Pain group between the post-treatment and 6-month follow-up.||||.021
72385775|NCT01967342|144278982|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.999|STANDARD_ERROR_OF_MEAN|0.244|<|0.001|TWO_SIDED|||||To control for multiple comparisons in secondary outcomes, a corrected alpha level was calculated using the Benjamini-Hochberg correction method. Smallest p-value compared to .025; Largest p-value compared to .050.|Mixed Models Analysis|||A piecewise linear growth model examined changes in BPI-Interference within Pain Ed group between the pre-treatment and 10-week post-treatment.||||< .001
72385776|NCT01967342|144278982|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.25|STANDARD_ERROR_OF_MEAN|0.243||0.305|TWO_SIDED|||||To control for multiple comparisons in secondary outcomes, a corrected alpha level was calculated using the Benjamini-Hochberg correction method. Smallest p-value compared to .025; Largest p-value compared to .050.|Mixed Models Analysis|||A piecewise linear growth model examined changes in BPI-Interference within Pain Ed group between the post-treatment and 6-month follow-up.||||.305
72385777|NCT01967342|144278983|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.086|STANDARD_ERROR_OF_MEAN|0.623||0.082|TWO_SIDED|||||To control for multiple comparisons in secondary outcomes, a corrected alpha level was calculated using the Benjamini-Hochberg correction method. Smallest p-value compared to .025; Largest p-value compared to .050.|Mixed Models Analysis|||A piecewise linear growth model examined changes in PHQ-9 within Usual Care group between the pre-treatment and 10-week post-treatment.||||.082
72385778|NCT01967342|144278983|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.24|STANDARD_ERROR_OF_MEAN|0.532||0.652|TWO_SIDED|||||To control for multiple comparisons in secondary outcomes, a corrected alpha level was calculated using the Benjamini-Hochberg correction method. Smallest p-value compared to .025; Largest p-value compared to .050.|Mixed Models Analysis|||A piecewise linear growth model examined changes in PHQ-9 within Usual Care group between the post-treatment and 6-month follow-up.||||.652
72385779|NCT01967342|144278983|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.416|STANDARD_ERROR_OF_MEAN|0.612|<|0.001|TWO_SIDED|||||To control for multiple comparisons in secondary outcomes, a corrected alpha level was calculated using the Benjamini-Hochberg correction method. Smallest p-value compared to .025; Largest p-value compared to .050.|Mixed Models Analysis|||A piecewise linear growth model examined changes in PHQ-9 within CBT for Pain group between the pre-treatment and 10-week post-treatment.||||< .001
72385780|NCT01967342|144278983|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.619|STANDARD_ERROR_OF_MEAN|0.528||0.241|TWO_SIDED|||||To control for multiple comparisons in secondary outcomes, a corrected alpha level was calculated using the Benjamini-Hochberg correction method. Smallest p-value compared to .025; Largest p-value compared to .050.|Mixed Models Analysis|||A piecewise linear growth model examined changes in PHQ-9 within CBT for Pain group between the post-treatment and 6-month follow-up.||||.241
72385781|NCT01967342|144278983|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.251|STANDARD_ERROR_OF_MEAN|0.617|<|0.001|TWO_SIDED|||||To control for multiple comparisons in secondary outcomes, a corrected alpha level was calculated using the Benjamini-Hochberg correction method. Smallest p-value compared to .025; Largest p-value compared to .050.|Mixed Models Analysis|||A piecewise linear growth model examined changes in PHQ-9 within Pain Ed group between the pre-treatment and 10-week post-treatment.||||< .001
72385782|NCT01967342|144278983|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.434|STANDARD_ERROR_OF_MEAN|0.541||0.422|TWO_SIDED|||||To control for multiple comparisons in secondary outcomes, a corrected alpha level was calculated using the Benjamini-Hochberg correction method. Smallest p-value compared to .025; Largest p-value compared to .050.|Mixed Models Analysis|||A piecewise linear growth model examined changes in PHQ-9 within Pain Ed group between the post-treatment and 6-month follow-up.||||.422
72385783|NCT01967342|144278984|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|8.45|||<|0.001|TWO_SIDED||||||Mixed Models Analysis||CBT vs. TAU|Odds ratios were computed to describe the likelihood of participants in each treatment condition reporting clinically meaningful improvement on the PGIC-pain intensity relative to the other groups at post-treatment (6-months).||||<.001
72385784|NCT01967342|144278984|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.53||||0.001|TWO_SIDED||||||Mixed Models Analysis||EDU vs. TAU|Odds ratios were computed to describe the likelihood of participants in each treatment condition reporting clinically meaningful improvement on the PGIC-pain intensity relative to the other groups at post-treatment (10-weeks).||||.001
72385785|NCT01967342|144278984|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.53||||0.217|TWO_SIDED||||||Mixed Models Analysis||CBT vs. EDU|Odds ratios were computed to describe the likelihood of participants in each treatment condition reporting clinically meaningful improvement on the PGIC-pain intensity relative to the other groups at pre-treatment (10-weeks).||||.217
72385786|NCT01967342|144278984|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.81||||0.009|TWO_SIDED||||||Mixed Models Analysis||CBT vs. TAU|Odds ratios were computed to describe the likelihood of participants in each treatment condition reporting clinically meaningful improvement on the PGIC-pain intensity relative to the other groups at follow-up (6-months).||||.009
72385787|NCT01967342|144278984|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.32||||0.001|TWO_SIDED||||||Mixed Models Analysis||EDU vs. TAU|Odds ratios were computed to describe the likelihood of participants in each treatment condition reporting clinically meaningful improvement on the PGIC-pain intensity relative to the other groups at follow-up (6-months).||||.001
72438263|NCT03622593|144389902|OTHER||Adjusted mean difference|-25.7|STANDARD_ERROR_OF_MEAN|5.95|||TWO_SIDED|95.0|-37.4|-14.0||||||This is the adjusted mean difference for Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W in the ITT Population.||-14.0|-37.4|
72438264|NCT03622593|144389902|OTHER||Adjusted mean difference|-17.6|STANDARD_ERROR_OF_MEAN|5.88|||TWO_SIDED|95.0|-29.2|-6.0||||||This is the adjusted mean difference for Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W in the ITT Population.||-6.0|-29.2|
72438265|NCT03622593|144389902|OTHER||Adjusted mean difference|-20.0|STANDARD_ERROR_OF_MEAN|6.59|||TWO_SIDED|95.0|-32.9|-7.0||||||This is the adjusted mean difference for Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W in the Treatment-Naive Population.||-7.0|-32.9|
72438266|NCT03622593|144389902|OTHER||Adjusted mean difference|-14.3|STANDARD_ERROR_OF_MEAN|6.51|||TWO_SIDED|95.0|-27.1|-1.5||||||This is the adjusted mean difference for Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W in the Treatment-Naive Population.||-1.5|-27.1|
72438267|NCT03622593|144389905|OTHER||Difference in CMH Weighted Percentage|12.3|||||TWO_SIDED|95.0|5.7|18.9||||||This is the difference in percentage of participants in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W for the ITT Population.||18.9|5.7|
72438268|NCT03622593|144389905|OTHER||Difference in CMH Weighted Percentage|8.2|||||TWO_SIDED|95.0|1.5|14.9||||||This is the difference in percentage of participants in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W for the ITT Population.||14.9|1.5|
72438269|NCT03622593|144389905|OTHER||Difference in CMH Weighted Percentage|9.0|||||TWO_SIDED|95.0|1.6|16.3||||||This is the difference in percentage of participants in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W for the Treatment-Naive Population.||16.3|1.6|
72438270|NCT03622593|144389905|OTHER||Difference in CMH Weighted Percentage|6.2|||||TWO_SIDED|95.0|-1.2|13.6||||||This is the difference in percentage of participants in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W for the Treatment-Naive Population.||13.6|-1.2|
72438271|NCT02139046|144389917|SUPERIORITY_OR_OTHER||Difference in Proportions|25.6|||<|0.001|TWO_SIDED|95.0|20.4|30.9||To adjust for multiple comparisons, a closed testing strategy was used. Febuxostat XR 40 and 80 mg were tested separately versus placebo and the corresponding febuxostat IR group at a Bonferroni-corrected significance level of 0.025.|Z-test|Point estimates, confidence intervals, and p-values are presented using the Cui, Hung, and Wang (CHW) Z-test which accounts for the interim analysis.||||30.9|20.4|<0.001
72438272|NCT02139046|144389917|SUPERIORITY_OR_OTHER||Difference in Proportions|49.8|||<|0.001|TWO_SIDED|95.0|43.9|55.8||To adjust for multiple comparisons, a closed testing strategy was used. Febuxostat XR 40 and 80 mg were tested separately versus placebo and the corresponding febuxostat IR group at a Bonferroni-corrected significance level of 0.025.|Z-test|Point estimates, confidence intervals, and p-values are presented using the CHW Z-test which accounts for the interim analysis.||||55.8|43.9|<0.001
72438273|NCT02139046|144389917|SUPERIORITY_OR_OTHER||Difference in Proportions|10.2||||0.001|TWO_SIDED|95.0|3.5|17.0||To adjust for multiple comparisons, a closed testing strategy was used. Febuxostat XR 40 and 80 mg were tested separately versus placebo and the corresponding febuxostat IR group at a Bonferroni-corrected significance level of 0.025.|Z-test|Point estimates, confidence intervals, and p-values are presented using the CHW Z-test which accounts for the interim analysis.||||17.0|3.5|0.001
72438274|NCT02139046|144389917|SUPERIORITY_OR_OTHER||Difference in Proportions|7.5||||0.043|TWO_SIDED|95.0|-0.8|15.9||To adjust for multiple comparisons, a closed testing strategy was used. Febuxostat XR 40 and 80 mg were tested separately versus placebo and the corresponding febuxostat IR group at a Bonferroni-corrected significance level of 0.025.|Z-test|Point estimates, confidence intervals, and p-values are presented using the CHW Z-test which accounts for the interim analysis.||||15.9|-0.8|0.043
72438275|NCT02139046|144389918|SUPERIORITY_OR_OTHER||Difference in Proportions|2.1||||0.503|TWO_SIDED|95.0|-4.9|9.0||To adjust for multiple comparisons, a closed testing strategy was used. Febuxostat XR 40 and 80 mg were tested separately versus placebo and the corresponding febuxostat IR group at a Bonferroni-corrected significance level of 0.025.|Z-test|Point estimates, confidence intervals, and p-values are presented using the CHW Z-test which accounts for the interim analysis.||||9.0|-4.9|0.503
72438276|NCT02139046|144389918|SUPERIORITY_OR_OTHER||Difference in Proportions|5.9||||0.064|TWO_SIDED|95.0|-1.2|13.0||To adjust for multiple comparisons, a closed testing strategy was used. Febuxostat XR 40 and 80 mg were tested separately versus placebo and the corresponding febuxostat IR group at a Bonferroni-corrected significance level of 0.025.|Z-test|Point estimates, confidence intervals, and p-values are presented using the CHW Z-test which accounts for the interim analysis.||||13.0|-1.2|0.064
72438277|NCT02139046|144389918|SUPERIORITY_OR_OTHER||Difference in Proportions|1.8||||0.561|TWO_SIDED|95.0|-5.1|8.7||To adjust for multiple comparisons, a closed testing strategy was used. Febuxostat XR 40 and 80 mg were tested separately versus placebo and the corresponding febuxostat IR group at a Bonferroni-corrected significance level of 0.025.|Z-test|Point estimates, confidence intervals, and p-values are presented using the CHW Z-test which accounts for the interim analysis.||||8.7|-5.1|0.561
72438278|NCT02139046|144389918|SUPERIORITY_OR_OTHER||Difference in Proportions|-0.5||||0.869|TWO_SIDED|95.0|-8.0|6.9||To adjust for multiple comparisons, a closed testing strategy was used. Febuxostat XR 40 and 80 mg were tested separately versus placebo and the corresponding febuxostat IR group at a Bonferroni-corrected significance level of 0.025.|Z-test|Point estimates, confidence intervals, and p-values are presented using the CHW Z-test which accounts for the interim analysis.||||6.9|-8.0|0.869
72438279|NCT02139046|144389919|SUPERIORITY_OR_OTHER||Difference in Proportions|47.6|||<|0.001|TWO_SIDED|95.0|41.6|53.6||To adjust for multiple comparisons, a closed testing strategy was used. Febuxostat XR 40 and 80 mg were tested separately versus placebo and the corresponding febuxostat IR group at a Bonferroni-corrected significance level of 0.025.|Z-test|Point estimates, confidence intervals, and p-values are presented using the CHW Z-test which accounts for the interim analysis.||||53.6|41.6|<0.001
72438280|NCT02139046|144389919|SUPERIORITY_OR_OTHER||Difference in Proportions|60.5|||<|0.001|TWO_SIDED|95.0|54.6|66.3||To adjust for multiple comparisons, a closed testing strategy was used. Febuxostat XR 40 and 80 mg were tested separately versus placebo and the corresponding febuxostat IR group at a Bonferroni-corrected significance level of 0.025.|Z-test|Point estimates, confidence intervals, and p-values are presented using the CHW Z-test which accounts for the interim analysis.||||66.3|54.6|<0.001
72438281|NCT02139046|144389919|SUPERIORITY_OR_OTHER||Difference in Proportions|7.8||||0.036|TWO_SIDED|95.0|-0.5|16.1||To adjust for multiple comparisons, a closed testing strategy was used. Febuxostat XR 40 and 80 mg were tested separately versus placebo and the corresponding febuxostat IR group at a Bonferroni-corrected significance level of 0.025.|Z-test|Point estimates, confidence intervals, and p-values are presented using the CHW Z-test which accounts for the interim analysis.||||16.1|-0.5|0.036
72495252|NCT01017952|144519565|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.81||||0.04|TWO_SIDED|95.0|0.66|0.99|||Generalized Linear Model|Assuming Negative Binomial distribution with logarithm of time on treatment as an offset variable.||||0.99|0.66|0.040
72495253|NCT01017952|144519565|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.79||||0.024|TWO_SIDED|95.0|0.64|0.97|||Generalized Linear Model|Assuming Negative Binomial distribution with logarithm of time on treatment as an offset variable.||||0.97|0.64|0.024
72495254|NCT01017952|144519565|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.69|||<|0.001|TWO_SIDED|95.0|0.56|0.85|||Generalized Linear Model|Assuming Negative Binomial distribution with logarithm of time on treatment as an offset variable.||||0.85|0.56|<0.001
72495255|NCT01017952|144519566|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.87||||0.177|TWO_SIDED|95.0|0.71|1.06|||Regression, Cox|||||1.06|0.71|0.177
72495256|NCT01017952|144519566|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.88||||0.036|TWO_SIDED|95.0|0.66|0.99|||Regression, Cox|||||0.99|0.66|0.036
72495257|NCT01017952|144519566|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.66|||<|0.001|TWO_SIDED|95.0|0.54|0.82|||Regression, Cox|||||0.82|0.54|<0.001
72495258|NCT01017952|144519567|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.84||||0.154|TWO_SIDED|95.0|0.65|1.07|||Generalized Linear Model|Assuming Negative Binomial distribution with logarithm of time on treatment as an offset variable.||||1.07|0.65|0.154
72495259|NCT01017952|144519567|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.77||||0.041|TWO_SIDED|95.0|0.6|0.99|||Generalized Linear Model|Assuming Negative Binomial distribution with logarithm of time on treatment as an offset variable||||0.99|0.60|0.041
72495260|NCT01017952|144519567|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.65|||<|0.001|TWO_SIDED|95.0|0.51|0.84|||Generalized Linear Model|Assuming Negative Binomial distribution with logarithm of time on treatment as an offset variable||||0.84|0.51|<0.001
72495261|NCT01017952|144519568|SUPERIORITY_OR_OTHER||Least squares mean difference|0.034||||0.034|TWO_SIDED|95.0|0.003|0.066||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).||||0.066|0.003|0.034
72558744|NCT02986139|144647465|SUPERIORITY||LS Mean Difference|-4.0||||0.048|TWO_SIDED|95.0|-8.0|0.0|||Mixed effects analysis of variance model|||A mixed effects analysis of variance model was used to assess injection site pain with the new formulation of etanercept as the test treatment and the commercial formulation of etanercept as the reference treatment. Treatment, study period, sequence, and disease indication were evaluated as fixed effect covariates, and subject within sequence was included as a random effect.||-0.0|-8.0|0.048
72558745|NCT00414726|144647468|SUPERIORITY_OR_OTHER|||||||0.91||95.0|||||Wilcoxon (Mann-Whitney)|We used the Van-Elteren extension of the Wilcoxon rank sum test; ajustments made for baseline NIHSS categories (4-11)(12-20)(\>20).||Subjects were analyzed using an intention to treat approach. All subjects were analyzed at 24 hours. For four subjects missing 24-hour NIHSS scores, the change score was given the highest possible value.||||0.91
72385788|NCT01967342|144278984|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.72||||0.389|TWO_SIDED||||||Mixed Models Analysis||CBT vs. EDU|Odds ratios were computed to describe the likelihood of participants in each treatment condition reporting clinically meaningful improvement on the PGIC-pain intensity relative to the other groups at follow-up (6-months).||||.389
72495262|NCT01017952|144519568|SUPERIORITY_OR_OTHER||Least squares mean difference|0.024||||0.143|TWO_SIDED|95.0|-0.008|0.056|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).||||0.056|-0.008|0.143
72495263|NCT01017952|144519568|SUPERIORITY_OR_OTHER||Least squares mean difference|0.026||||0.115|TWO_SIDED|95.0|-0.006|0.057|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).||||0.057|-0.006|0.115
72495264|NCT04849780|144519569|NON_INFERIORITY|It was calculated that 80 participants randomized in a 1:1 fashion between the two arms would have at least 80% power to detect a 5 points difference in mean change from baseline overall comfort. Sample size was determined using a 2-sided Satterthwaite t-test assuming unequal variances with an alpha level of 5%. A non-inferiority margin of -5 points was used.|Population Mean Difference|29.279|||||TWO_SIDED|95.0|24.602|33.732|||Bootstrapping methods||Population Mean difference was calculated as Arm 1 minus Arm 2|||33.732|24.602|
72495265|NCT04849780|144519570|NON_INFERIORITY|Sample size was determined based on the primary hypothesis only. A non-inferiority margin of 3 points was used.|LS Mean|-10.7|STANDARD_ERROR_OF_MEAN|1.03|||TWO_SIDED|95.0|-12.7|-8.6|||Heterogeneous Mixed model analysis|The Kenward and Roger method was used for the denominator degrees of freedom.|Mean difference was calculated as Arm 1 minus Arm 2 (subjects' own contact lens)|||-8.6|-12.7|
72558746|NCT00414726|144647469|SUPERIORITY_OR_OTHER|||||||0.68||95.0|||||Wilcoxon (Mann-Whitney)|We used the Van Elteren extension of the Wilcoxin rank sum test that adjusts for stratified randomization.||||||0.68
72495266|NCT04849780|144519571|NON_INFERIORITY|Sample size was determined based on the primary hypothesis only. A non-inferiority margin of -5 points was used.|LS Mean|25.9|STANDARD_ERROR_OF_MEAN|3.3|||TWO_SIDED|95.0|19.0|32.9|||Heterogeneous Mixed model analysis|The Kenward and Roger method was used for the denominator degrees of freedom.|Mean difference was calculated as Arm 2 (senofilcon A), minus Arm 2 (subjects' own contact lens)|||32.9|19.0|
72495267|NCT04849780|144519572|NON_INFERIORITY|A non-inferiority margin of 3 points was used.|LS Mean|-8.5|STANDARD_ERROR_OF_MEAN|0.75|||TWO_SIDED|95.0|-10.1|-7.0|||Heterogeneous mixed model analysis||Mean difference was calculated as Arm 2 (senofilcon A) minus Arm 2 (subjects' own contact lens)|||-7.0|-10.1|
72495268|NCT01665144|144519577|SUPERIORITY||Hazard Ratio (HR)|0.79||||0.0134|TWO_SIDED|95.0|0.65|0.95|||Cox proportional hazards model|||||0.95|0.65|0.0134
72495269|NCT01665144|144519578|SUPERIORITY||Hazard Ratio (HR)|0.94||||0.4398|TWO_SIDED|95.0|0.8|1.1|||Cox proportional hazards model|||||1.10|0.80|0.4398
72495270|NCT01665144|144519579|SUPERIORITY||Mean Difference (Final Values)|-613.1|STANDARD_ERROR_OF_MEAN|95.39|<|0.0001|TWO_SIDED|95.0|-800.2|-426.0|||Mixed model for repeated measures|||Month 12||-426.0|-800.2|<0.0001
72495271|NCT01665144|144519579|SUPERIORITY||Mean Difference (Final Values)|-777.5|STANDARD_ERROR_OF_MEAN|108.62|<|0.0001|TWO_SIDED|95.0|-990.6|-564.4|||Mixed model for repeated measures|||Month 24||-564.4|-990.6|<0.0001
72495272|NCT01665144|144519579|SUPERIORITY||Mean Difference (Final Values)|-695.3|STANDARD_ERROR_OF_MEAN|92.79|<|0.0001|TWO_SIDED|95.0|-877.3|-513.3|||Mixed model for repeated measures|||Average over Month 12 and Month 24||-513.3|-877.3|<0.0001
72495273|NCT01665144|144519580|SUPERIORITY||Hazard Ratio (HR)|0.74||||0.0058|TWO_SIDED|95.0|0.6|0.92|||Cox proportional hazards model|||||0.92|0.60|0.0058
72495274|NCT01665144|144519581|SUPERIORITY||ARR ratio|0.445|||<|0.0001|TWO_SIDED|95.0|0.337|0.587|||Negative binomial regression model|||||0.587|0.337|<0.0001
72618849|NCT06097273|144768199|NON_INFERIORITY|The noninferiority in SRR in the Cohort B1 group compared with that of Cohort B2 group was demonstrated if the lower bound of the 97.5% CI of the SRR difference was \>-10%.|Percentage Difference|8.1|||||TWO_SIDED|97.5|5.2|11.0||||||Percentage Difference (Cohort B1 vs Cohort B2) for SARS-CoV-2 Antibody||11.0|5.2|
72618850|NCT01902303|144768213|SUPERIORITY_OR_OTHER||||||>|0.5|TWO_SIDED||||||Chi-squared|||||||>.5000
72618851|NCT01902303|144768214|SUPERIORITY_OR_OTHER|||||||0.3835|TWO_SIDED||||||Chi-squared|||||||.3835
72495275|NCT01665144|144519582|SUPERIORITY||Hazard Ratio (HR)|0.54|||<|0.0001|TWO_SIDED|95.0|0.41|0.7|||Cox proportional hazards model|||||0.70|0.41|<0.0001
72618852|NCT04359680|144768257|SUPERIORITY||Odds Ratio (OR)|1.029||||0.9434|TWO_SIDED|95.0|0.4696|2.2546|||Cochran-Mantel-Haenszel|||||2.2546|0.4696|0.9434
72618853|NCT04359680|144768258|SUPERIORITY||Odds Ratio (OR)|1.1162||||0.6805|TWO_SIDED|95.0|0.6623|1.8813|||Cochran-Mantel-Haenszel|||||1.8813|0.6623|0.6805
72618854|NCT04359680|144768260|SUPERIORITY|||||||0.3459|||||||Cochran-Mantel-Haenszel|||||||0.3459
72618855|NCT03931785|144768271|SUPERIORITY||Least squares (LS) mean difference|0.08||||0.7467|TWO_SIDED|95.0|-0.42|0.58|||MMRM||MD-7246 minus placebo|||0.58|-0.42|0.7467
72618856|NCT03931785|144768271|SUPERIORITY||LS mean difference|0.43||||0.0941|TWO_SIDED|95.0|-0.07|0.93|||MMRM||MD-7246 minus placebo|||0.93|-0.07|0.0941
72618857|NCT03931785|144768271|SUPERIORITY||LS mean difference|0.06||||0.8098|TWO_SIDED|95.0|-0.44|0.56|||MMRM||MD-7246 minus placebo|||0.56|-0.44|0.8098
72385789|NCT03789214|144278987|OTHER|One-way ANOVA||||||0.95|||||||ANOVA|||||||.950
72385790|NCT03789214|144278988|OTHER|One-way ANOVA||||||0.048|||||||ANOVA|||||||.048
72385791|NCT03789214|144278989|OTHER|One-way ANOVA||||||0.691|||||||ANOVA|||||||.691
72385792|NCT03789214|144278990|OTHER|One-way ANOVA||||||0.62|||||||ANOVA|||||||.620
72385793|NCT03789214|144278991|OTHER|One-way ANOVA||||||0.067|||||||ANOVA|||||||.067
72385794|NCT02633501|144279024|SUPERIORITY||Least Squares Mean|-10.59|STANDARD_ERROR_OF_MEAN|2.0|||TWO_SIDED|||||Testing procedure stopped|Mixed Models Analysis|||Holm's Step-Down Method||||
72385795|NCT02633501|144279024|SUPERIORITY||Least Squares Mean|2.18|STANDARD_ERROR_OF_MEAN|2.42||0.1858|TWO_SIDED|||||Superiority not confirmed|Mixed Models Analysis|||Holm's Step-Down Method||||0.1858
72385796|NCT02633501|144279024|SUPERIORITY||Least Squares Mean|8.66|STANDARD_ERROR_OF_MEAN|2.55||0.0007|TWO_SIDED|||||Superiority confirmed|Mixed Models Analysis|||Holm's Step-Down Method||||0.0007
72385797|NCT02633501|144279024|SUPERIORITY||Least Squares Mean|14.45|STANDARD_ERROR_OF_MEAN|3.37|<|0.0001|TWO_SIDED|||||Superiority confirmed|Mixed Models Analysis|||Holm's Step-Down Method||||<0.0001
72385798|NCT02633501|144279024|SUPERIORITY||Least Squares Mean|-14.14|STANDARD_ERROR_OF_MEAN|4.55|||TWO_SIDED|||||Testing procedure stopped|Mixed Models Analysis|||Holm's Step-Down Method||||
72385799|NCT02633501|144279024|SUPERIORITY||Least Squares Mean|1.91|STANDARD_ERROR_OF_MEAN|4.56||0.3384|TWO_SIDED|||||Superiority not confirmed|Mixed Models Analysis|||Holm's Step-Down Method||||0.3384
72385800|NCT02633501|144279024|SUPERIORITY||Least Squares Mean|19.38|STANDARD_ERROR_OF_MEAN|3.94|<|0.0001|TWO_SIDED|||||Superiority confirmed|Mixed Models Analysis|||Holm's Step-Down Method||||<0.0001
72385801|NCT02633501|144279024|SUPERIORITY||Least Squares Mean|38.37|STANDARD_ERROR_OF_MEAN|9.76||0.0002|TWO_SIDED|||||Superiority confirmed|Mixed Models Analysis|||Holm's Step-Down Method||||0.0002
72385802|NCT02633501|144279024|SUPERIORITY||Least Squares Mean|-23.96|STANDARD_ERROR_OF_MEAN|4.88|||TWO_SIDED|||||Testing procedure stopped|Mixed Models Analysis|||Holm's Step-Down Method||||
72385803|NCT02633501|144279024|SUPERIORITY||Least Squares Mean|2.47|STANDARD_ERROR_OF_MEAN|5.4||0.3249|TWO_SIDED|||||Superiority not confirmed|Mixed Models Analysis|||Holm's Step-Down Method||||0.3249
72385804|NCT02633501|144279024|SUPERIORITY||Least Squares Mean|29.23|STANDARD_ERROR_OF_MEAN|6.53|<|0.0001|TWO_SIDED|||||Superiority confirmed|Mixed Models Analysis|||Holm's Step-Down Method||||<0.0001
72385805|NCT02633501|144279024|SUPERIORITY||Least Squares Mean|51.96|STANDARD_ERROR_OF_MEAN|10.68|<|0.0001|TWO_SIDED|||||Superiority confirmed|Mixed Models Analysis|||Holm's Step-Down Method||||<0.0001
72385806|NCT00910273|144279035|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.72||||0.608|TWO_SIDED|95.0|-5.14|8.58|||Mixed Models Analysis|||"Null Hypothesis: No difference in Change in FMD at 12 weeks for Etanercept and placebo.~Alternative Hypothesis: Difference in Change in FMD at 12 weeks for Etanercept and placebo.~Sample size of 36 subjects per treatment arm was planned based on an expected difference of 0.9 in FMD (Standard Deviation \[SD\] 1.5), with 80% power and 5% significance level."||8.58|-5.14|0.608
72385807|NCT00910273|144279036|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.82||||0.476|TWO_SIDED|95.0|-3.35|7.0|||Mixed Models Analysis||Analyses available for Week 4 only, due to limited number of participants for Week 24 to Week 52.|Week 4||7.00|-3.35|0.476
72385808|NCT00910273|144279037|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.02||||0.65|TWO_SIDED|95.0|-0.08|0.13|||ANCOVA|||Week 12; Common Carotid Artery; Due to limited number of participants with visits after Week 12 analysis limited to Week 12||0.13|-0.08|0.650
72385809|NCT00910273|144279037|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.03||||0.513|TWO_SIDED|95.0|-0.13|0.07|||ANCOVA|||Week 12; Common Bulb; Due to limited number of participants with visits after Week 12 analysis limited to Week 12||0.07|-0.13|0.513
72385810|NCT00910273|144279037|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.03||||0.592|TWO_SIDED|95.0|-0.14|0.08|||ANCOVA|||Week 12; Internal Carotid Artery; Due to limited number of participants with visits after Week 12 analysis limited to Week 12||0.08|-0.14|0.592
72385811|NCT00910273|144279042|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.77||||0.008|TWO_SIDED|95.0|-3.05|-0.5|||Mixed Models Analysis||Adjusted mean difference (Etanercept-Placebo)|Week 4||-0.50|-3.05|0.008
72385812|NCT00910273|144279042|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.02||||0.021|TWO_SIDED|95.0|-3.7|-0.33|||Mixed Models Analysis||Adjusted mean difference (Etanercept-Placebo)|Week 12||-0.33|-3.70|0.021
72385813|NCT00910273|144279050|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.07||||0.003|TWO_SIDED|95.0|-1.74|-0.4|||Mixed Models Analysis||Adjusted mean difference (Etanercept-Placebo)|Week 4||-0.40|-1.74|0.003
72385814|NCT00910273|144279050|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.91||||0.029|TWO_SIDED|95.0|-1.72|-0.1|||Mixed Models Analysis||Adjusted mean difference (Etanercept-Placebo)|Week 12||-0.10|-1.72|0.029
72385815|NCT00910273|144279056|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.09||||0.041|TWO_SIDED|95.0|-2.13|-0.05|||Mixed Models Analysis||Adjusted mean difference (Etanercept-Placebo)|Week 4||-0.05|-2.13|0.041
72438282|NCT02139046|144389919|SUPERIORITY_OR_OTHER||Difference in Proportions|3.3||||0.364|TWO_SIDED|95.0|-4.9|11.6||To adjust for multiple comparisons, a closed testing strategy was used. Febuxostat XR 40 and 80 mg were tested separately versus placebo and the corresponding febuxostat IR group at a Bonferroni-corrected significance level of 0.025.|Z-test|Point estimates, confidence intervals, and p-values are presented using the CHW Z-test which accounts for the interim analysis.||||11.6|-4.9|0.364
72438283|NCT03675581|144389920|OTHER|Relative systemic exposure|Ratio of the geometric means (T/R) %|101.36|STANDARD_DEVIATION|13.7|||TWO_SIDED|90.0|92.83|110.67|||ANOVA|"The statistical model was analysis of variance (ANOVA) on the logarithmic scale considering the effects subjects as random and treatment as fixed."|The standard deviation is actually the geometric coefficient of variation (gCV) T=Test, R=Reference|||110.67|92.83|
72438284|NCT03675581|144389921|OTHER|Relative systemic exposure|Ratio of the geometric means (T/R) %|96.4|STANDARD_DEVIATION|8.2|||TWO_SIDED|90.0|91.48|101.58|||ANOVA|"The statistical model was analysis of variance (ANOVA) on the logarithmic scale considering the effects subjects as random and treatment as fixed."|The standard deviation is actually the geometric coefficient of variation (gCV) T = Test, R = Reference|||101.58|91.48|
72438285|NCT03675581|144389922|OTHER|Relative systemic exposure|Ratio of the geometric means (T/R) %|116.69|STANDARD_DEVIATION|12.6|||TWO_SIDED|90.0|107.63|126.51|||ANOVA|"The statistical model was analysis of variance (ANOVA) on the logarithmic scale considering the effects subjects as random and treatment as fixed."|The standard deviation is actually the geometric coefficient of variation (gCV) T=Test, R=Reference|||126.51|107.63|
72438286|NCT03675581|144389923|OTHER|Relative systemic exposure|Ratio of the geometric means (T/R) %|100.89|STANDARD_DEVIATION|18.1|||TWO_SIDED|90.0|89.9|113.23|||ANOVA|"The statistical model was analysis of variance (ANOVA) on the logarithmic scale considering the effects subjects as random and treatment as fixed."|The standard deviation is actually the geometric coefficient of variation (gCV) T=Test, R=Reference|||113.23|89.90|
72438287|NCT03675581|144389924|OTHER|Relative systemic exposure|Ratio of the geometric means (T/R) %|101.24|STANDARD_DEVIATION|11.7|||TWO_SIDED|90.0|93.95|109.1|||ANOVA|"The statistical model was analysis of variance (ANOVA) on the logarithmic scale considering the effects subjects as random and treatment as fixed."|The standard deviation is actually the geometric coefficient of variation (gCV) T=Test, R=Reference|||109.10|93.95|
72438288|NCT03675581|144389925|OTHER|Relative systemic exposure|Ratio of the geometric means (T/R) %|88.09|STANDARD_DEVIATION|15.0|||TWO_SIDED|90.0|80.03|96.96|||ANOVA|"The statistical model was analysis of variance (ANOVA) on the logarithmic scale considering the effects subjects as random and treatment as fixed."|The standard deviation is actually the geometric coefficient of variation (gCV) T=Test, R=Reference|||96.96|80.03|
72438289|NCT03691428|144389960|SUPERIORITY||||||<|0.05|||||||Mixed Models Analysis|||||||<.05
72438290|NCT03691428|144389961|SUPERIORITY|A multivariate dyadic linear growth curve model was used to predict the trajectories of psychological well-being (Raudenbush, Brennan, \& Barnett, 1995).|||||<|0.05|||||||Mixed Models Analysis|||||||<.05
72438291|NCT03691428|144389962|SUPERIORITY||||||<|0.05|||||||Mixed Models Analysis|||||||<.05
72438292|NCT03691428|144389963|SUPERIORITY||||||<|0.05|||||||Mixed Models Analysis|||||||<.05
72438293|NCT03691428|144389964|SUPERIORITY||||||<|0.05|||||||Mixed Models Analysis|||||||<.05
72438294|NCT02527148|144389965|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||Improvement from preoperative to 6 weeks for the control cases||||<0.0001
72438295|NCT02527148|144389965|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||Improvement from preoperative to 6 weeks for the Shapematch cases||||<0.0001
72438296|NCT02527148|144389965|SUPERIORITY|||||||0.0004|||||||t-test, 2 sided|||To compare improvement of OKS from preoperative to 6 weeks between both groups.||||0.0004
72438297|NCT02527148|144389965|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||Improvement from preoperative to 6 months for Control cases.||||<0.0001
72438298|NCT02527148|144389965|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||Improvement form preoperative to 6 months for Shapematch cases.||||<0.0001
72438299|NCT02527148|144389965|SUPERIORITY|||||||0.3894|||||||t-test, 2 sided|||To compare improvement of OKS from preoperative to 6 months between both groups.||||0.3894
72438300|NCT02527148|144389965|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||Improvement from preoperative to 12 months for the Control cases||||<0.0001
72438301|NCT02527148|144389965|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||Improvement from preoperative to 12 months for the Shapematch cases||||<0.0001
72438302|NCT02527148|144389965|SUPERIORITY|||||||0.4387|||||||t-test, 2 sided|p-values from repeated ANOVA with change from preoperative variable/scores as dependent variable.||To compare improvement of OKS from preoperative to 12 months between both groups.||||0.4387
72438303|NCT02527148|144389965|SUPERIORITY|||||||0.261|||||||t-test, 2 sided|||To compare improvement of OKS from preoperative to 2 years between both groups.||||0.2610
72438304|NCT02527148|144389965|SUPERIORITY|||||||0.8458|||||||t-test, 2 sided|||To compare improvement of OKS from preoperative to 5 years between both groups.||||0.8458
72495276|NCT01665144|144519584|SUPERIORITY||Mean Difference (Final Values)|-1.83|STANDARD_ERROR_OF_MEAN|1.03||0.0764|TWO_SIDED|95.0|-3.85|0.19|||Repeated measures model|||Month 12||0.19|-3.85|0.0764
72495277|NCT01665144|144519584|SUPERIORITY||Mean Difference (Final Values)|-1.23|STANDARD_ERROR_OF_MEAN|1.359||0.3671|TWO_SIDED|95.0|-3.89|1.44|||Repeated measures model|||Month 24||1.44|-3.89|0.3671
72438305|NCT02527148|144389966|SUPERIORITY|||||||0.1|||||||t-test, 2 sided|||To compare mean duration of surgery between both groups.||||0.10
72438306|NCT02527148|144389967|SUPERIORITY|||||||0.05|||||||t-test, 2 sided|||To compare wound length between both groups.||||0.05
72438307|NCT02527148|144389969|SUPERIORITY|||||||0.07|||||||t-test, 2 sided|||To compare average length of hospital stay between both groups.||||0.07
72438308|NCT02527148|144389970|SUPERIORITY||Mean Difference (Final Values)|-0.023||||0.55|TWO_SIDED||||||t-test, 2 sided|||Comparison of baseline differences||||0.55
72438309|NCT02527148|144389970|SUPERIORITY||Mean Difference (Final Values)|-0.043||||0.23|TWO_SIDED||||||t-test, 2 sided|||Analysis of QALY between each instrument platform at 12-months||||0.23
72438310|NCT02527148|144389971|EQUIVALENCE|To determine equivalence in baseline characteristics between the control and intervention group.||||||0.724|||||||t-test, 2 sided|||To compare VAS rest preoperatively between both groups.||||0.7240
72438311|NCT02527148|144389971|EQUIVALENCE|To determine equivalence in baseline characteristics between the control and intervention group.||||||0.7545|||||||t-test, 2 sided|||To compare VAS mobilisation preoperatively between both groups.||||0.7545
72385816|NCT00910273|144279056|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.28||||0.048|TWO_SIDED|95.0|-2.55|-0.01|||Mixed Models Analysis||Adjusted mean difference (Etanercept-Placebo)|Week 12||-0.01|-2.55|0.048
72385817|NCT00910273|144279057|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.34||||0.575|TWO_SIDED|95.0|-0.89|1.57|||Mixed Models Analysis||Adjusted mean difference (Etanercept-Placebo)|Week 4||1.57|-0.89|0.575
72385818|NCT00910273|144279057|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.89||||0.204|TWO_SIDED|95.0|-0.52|2.3|||Mixed Models Analysis||Adjusted mean difference (Etanercept-Placebo)|Week 12||2.30|-0.52|0.204
72385819|NCT01346969|144279067|OTHER|LS Mean, SE, 95% confidence interval, and p-value were derived from MMRM model that includes fixed factors for treatment, pooled site, scheduled visit, an interaction for treatment by scheduled visit, and a covariate for Fitzpatrick category.|LS Mean|0.0|STANDARD_ERROR_OF_MEAN|0.38||1|TWO_SIDED|95.0|-0.8|0.8|||Mixed Models Analysis|||Overall Opinion: Intraparticipant analysis||0.8|-0.8|1.000
72385820|NCT01346969|144279067|OTHER|LS Mean, SE, 95% confidence interval, and p-value were derived from MMRM model that includes fixed factors for treatment, pooled site, scheduled visit, an interaction for treatment by scheduled visit, and a covariate for Fitzpatrick category.|LS Mean|0.0|STANDARD_ERROR_OF_MEAN|0.37||1|TWO_SIDED|95.0|-0.7|0.7|||Mixed Models Analysis|||Vascularity: Intraparticipant analysis||0.7|-0.7|1.000
72385821|NCT01346969|144279067|OTHER|LS Mean, SE, 95% confidence interval, and p-value were derived from MMRM model that includes fixed factors for treatment, pooled site, scheduled visit, an interaction for treatment by scheduled visit, and a covariate for Fitzpatrick category.|LS Mean|-0.3|STANDARD_ERROR_OF_MEAN|0.36||0.391|TWO_SIDED|95.0|-1.0|0.4|||Mixed Models Analysis|||Pigmentation: Intraparticipant analysis||0.4|-1.0|0.391
72385822|NCT01346969|144279067|OTHER|LS Mean, SE, 95% confidence interval, and p-value were derived from MMRM model that includes fixed factors for treatment, pooled site, scheduled visit, an interaction for treatment by scheduled visit, and a covariate for Fitzpatrick category.|LS Mean|0.2|STANDARD_ERROR_OF_MEAN|0.39||0.696|TWO_SIDED|95.0|-0.6|0.9|||Mixed Models Analysis|||Thickness: Intraparticipant analysis||0.9|-0.6|0.696
72385823|NCT01346969|144279067|OTHER|LS Mean, SE, 95% confidence interval, and p-value were derived from MMRM model that includes fixed factors for treatment, pooled site, scheduled visit, an interaction for treatment by scheduled visit, and a covariate for Fitzpatrick category.|LS Mean|0.0|STANDARD_ERROR_OF_MEAN|0.39||0.921|TWO_SIDED|95.0|-0.7|0.8|||Mixed Models Analysis|||Relief: Intraparticipant analysis||0.8|-0.7|0.921
72385824|NCT01346969|144279067|OTHER|LS Mean, SE, 95% confidence interval, and p-value were derived from MMRM model that includes fixed factors for treatment, pooled site, scheduled visit, an interaction for treatment by scheduled visit, and a covariate for Fitzpatrick category.|LS Mean|0.2|STANDARD_ERROR_OF_MEAN|0.39||0.693|TWO_SIDED|95.0|-0.6|0.9|||Mixed Models Analysis|||Pliability: Intraparticipant analysis||0.9|-0.6|0.693
72385825|NCT01346969|144279067|OTHER|LS Mean, SE, 95% confidence interval, and p-value were derived from MMRM model that includes fixed factors for treatment, pooled site, scheduled visit, an interaction for treatment by scheduled visit, and a covariate for Fitzpatrick category.|LS Mean|0.1|STANDARD_ERROR_OF_MEAN|0.39||0.77|TWO_SIDED|95.0|-0.7|0.9|||Mixed Models Analysis|||Surface Area: Intraparticipant analysis||0.9|-0.7|0.770
72385826|NCT01346969|144279067|OTHER|LS Mean, SE, 95% confidence interval, and p-value were derived from MMRM model that includes fixed factors for treatment, pooled site, scheduled visit, an interaction for treatment by scheduled visit, and a covariate for Fitzpatrick category.|LS Mean|0.2|STANDARD_ERROR_OF_MEAN|1.98||0.938|TWO_SIDED|95.0|-3.7|4.0|||Mixed Models Analysis|||Composite Score: Intraparticipant analysis||4.0|-3.7|0.938
72385827|NCT01346969|144279067|OTHER|LS Mean, SE, 95% confidence interval, and p-value were derived from MMRM model that includes fixed factors for treatment, pooled site, scheduled visit, an interaction for treatment by scheduled visit, and a covariate for Fitzpatrick category.|LS Mean|-0.5|STANDARD_ERROR_OF_MEAN|0.52||0.34|TWO_SIDED|95.0|-1.5|0.5|||Mixed Models Analysis|||Overall Opinion: Intraparticipant analysis||0.5|-1.5|0.340
72385828|NCT01346969|144279067|OTHER|LS Mean, SE, 95% confidence interval, and p-value were derived from MMRM model that includes fixed factors for treatment, pooled site, scheduled visit, an interaction for treatment by scheduled visit, and a covariate for Fitzpatrick category.|LS Mean|-0.6|STANDARD_ERROR_OF_MEAN|0.5||0.258|TWO_SIDED|95.0|-1.6|0.4|||Mixed Models Analysis|||Vascularity: Intraparticipant analysis||0.4|-1.6|0.258
72438312|NCT02527148|144389971|NON_INFERIORITY|Precision Knee Navigation is the current standard of care and is the control against the newer intervention of OtisMed® ShapeMatch® with Triathlon||||||0.6921|||||||t-test, 2 sided|||To compare VAS rest at 6 weeks between both groups.||||0.6921
72438313|NCT02527148|144389971|NON_INFERIORITY|Precision Knee Navigation is the current standard of care and is the control against the newer intervention of OtisMed® ShapeMatch® with Triathlon||||||0.9601|||||||t-test, 2 sided|||To compare VAS mobilisation at 6 weeks between both groups.||||0.9601
72438314|NCT02527148|144389971|NON_INFERIORITY|Precision Knee Navigation is the current standard of care and is the control against the newer intervention of OtisMed® ShapeMatch® with Triathlon||||||0.0697|||||||t-test, 2 sided|||To compare VAS rest at 6 months between both groups.||||0.0697
72618858|NCT03931785|144768272|SUPERIORITY||Difference in Responder Rate|1.0|||||TWO_SIDED|95.0|-12.9|15.0|||||Difference in responder rate (MD-7246 - placebo). 95% confidence intervals (CIs) for differences in responder rates were obtained using the normal approximation to the binomial distribution.|||15.0|-12.9|
72385829|NCT01346969|144279067|OTHER|LS Mean, SE, 95% confidence interval, and p-value were derived from MMRM model that includes fixed factors for treatment, pooled site, scheduled visit, an interaction for treatment by scheduled visit, and a covariate for Fitzpatrick category.|LS Mean|-0.4|STANDARD_ERROR_OF_MEAN|0.49||0.381|TWO_SIDED|95.0|-1.4|0.5|||Mixed Models Analysis|||Pigmentation: Intraparticipant analysis||0.5|-1.4|0.381
72495278|NCT01665144|144519585|SUPERIORITY||Rate ratio|0.126|||<|0.0001|TWO_SIDED|95.0|0.083|0.191|||Negative binomial regression model|||Month 12||0.191|0.083|<0.0001
72618859|NCT03931785|144768272|SUPERIORITY||Difference in Responder Rate|-11.3|||||TWO_SIDED|95.0|-25.3|2.6|||||Difference in responder rate (MD-7246 - placebo). 95% CIs for differences in responder rates were obtained using the normal approximation to the binomial distribution.|||2.6|-25.3|
72438315|NCT02527148|144389971|EQUIVALENCE|Precision Knee Navigation is the current standard of care and is the control against the newer intervention of OtisMed® ShapeMatch® with Triathlon||||||0.0342|||||||t-test, 2 sided|||To compare VAS mobilisation at 6 months between both groups.||||0.0342
72438316|NCT02527148|144389971|EQUIVALENCE|Precision Knee Navigation is the current standard of care and is the control against the newer intervention of OtisMed® ShapeMatch® with Triathlon||||||0.3487|||||||t-test, 2 sided|||To compare VAS rest at 12 months between both groups.||||0.3487
72495279|NCT01665144|144519585|SUPERIORITY||Rate ratio|0.178|||<|0.0001|TWO_SIDED|95.0|0.087|0.362|||Negative binomial regression model|||Month 24||0.362|0.087|<0.0001
72495280|NCT01665144|144519586|SUPERIORITY||Rate ratio|0.266|||<|0.0001|TWO_SIDED|95.0|0.215|0.328|||Regression model|Repeated measures negative binomial regression model||Month 12||0.328|0.215|<0.0001
72495281|NCT01665144|144519586|SUPERIORITY||Rate ratio|0.142|||<|0.0001|TWO_SIDED|95.0|0.103|0.196|||Regression model|Repeated measures negative binomial regression model||Month 24||0.196|0.103|<0.0001
72495282|NCT01665144|144519587|SUPERIORITY||Mean Difference (Final Values)|0.175|STANDARD_ERROR_OF_MEAN|0.0367|<|0.0001|TWO_SIDED|95.0|0.103|0.247|||Repeated measures model|||Month 12||0.247|0.103|<0.0001
72495283|NCT01665144|144519587|SUPERIORITY||Mean Difference (Final Values)|0.128|STANDARD_ERROR_OF_MEAN|0.0549||0.0196|TWO_SIDED|95.0|0.021|0.236|||Repeated measures model|||Month 24||0.236|0.021|0.0196
72495284|NCT01665144|144519588|SUPERIORITY||Hazard Ratio (HR)|0.87|||||TWO_SIDED|95.0|0.68|1.11|||Cox proportional hazard model|||Without superimposed relapses at baseline||1.11|0.68|
72385830|NCT01346969|144279067|OTHER|LS Mean, SE, 95% confidence interval, and p-value were derived from MMRM model that includes fixed factors for treatment, pooled site, scheduled visit, an interaction for treatment by scheduled visit, and a covariate for Fitzpatrick category.|LS Mean|-0.6|STANDARD_ERROR_OF_MEAN|0.54||0.287|TWO_SIDED|95.0|-1.6|0.5|||Mixed Models Analysis|||Thickness: Intraparticipant analysis||0.5|-1.6|0.287
72438317|NCT02527148|144389971|EQUIVALENCE|Precision Knee Navigation is the current standard of care and is the control against the newer intervention of OtisMed® ShapeMatch® with Triathlon||||||0.2201|||||||t-test, 2 sided|||To compare VAS mobilisation at 1 year between both groups.||||0.2201
72438318|NCT02527148|144389971|EQUIVALENCE|Precision Knee Navigation is the current standard of care and is the control against the newer intervention of OtisMed® ShapeMatch® with Triathlon||||||0.2291|||||||t-test, 2 sided|||To compare VAS rest at 2 years between both groups.||||0.2291
72438319|NCT02527148|144389971|EQUIVALENCE|Precision Knee Navigation is the current standard of care and is the control against the newer intervention of OtisMed® ShapeMatch® with Triathlon||||||0.6436|||||||t-test, 2 sided|||To compare VAS mobilisation at 2 years between both groups.||||0.6436
72438320|NCT02527148|144389971|EQUIVALENCE|Precision Knee Navigation is the current standard of care and is the control against the newer intervention of OtisMed® ShapeMatch® with Triathlon||||||0.4344|||||||t-test, 2 sided|||To compare VAS rest at 5 years between both groups.||||0.4344
72495285|NCT01665144|144519588|SUPERIORITY||Hazard Ratio (HR)|0.67|||||TWO_SIDED|95.0|0.49|0.91|||Cox proportional hazard model|||With superimposed relapses at baseline||0.91|0.49|
72495286|NCT01665144|144519588|SUPERIORITY||Hazard Ratio (HR)|0.85|||||TWO_SIDED|95.0|0.69|1.06|||Cox proportional hazard model|||Without superimposed relapses post-treatment||1.06|0.69|
72385831|NCT01346969|144279067|OTHER|LS Mean, SE, 95% confidence interval, and p-value were derived from MMRM model that includes fixed factors for treatment, pooled site, scheduled visit, an interaction for treatment by scheduled visit, and a covariate for Fitzpatrick category.|LS Mean|-0.4|STANDARD_ERROR_OF_MEAN|0.53||0.42|TWO_SIDED|95.0|-1.5|0.6|||Mixed Models Analysis|||Relief: Intraparticipant analysis||0.6|-1.5|0.420
72385832|NCT01346969|144279067|OTHER|LS Mean, SE, 95% confidence interval, and p-value were derived from MMRM model that includes fixed factors for treatment, pooled site, scheduled visit, an interaction for treatment by scheduled visit, and a covariate for Fitzpatrick category.|LS Mean|-0.6|STANDARD_ERROR_OF_MEAN|0.53||0.227|TWO_SIDED|95.0|-1.7|0.4|||Mixed Models Analysis|||Pliability: Intraparticipant analysis||0.4|-1.7|0.227
72438321|NCT02527148|144389971|EQUIVALENCE|Precision Knee Navigation is the current standard of care and is the control against the newer intervention of OtisMed® ShapeMatch® with Triathlon||||||0.8732|||||||t-test, 2 sided|||To compare VAS mobilisation at 5 years between both groups.||||0.8732
72438322|NCT02527148|144389972|SUPERIORITY|||||||0.911|||||||t-test, 2 sided|||To compare WOMAC preoperatively between both groups.||||0.911
72438323|NCT02527148|144389972|SUPERIORITY|||||||0.588|||||||t-test, 2 sided|||To compare WOMAC at 6-weeks between both groups.||||0.588
72438324|NCT02527148|144389972|SUPERIORITY|||||||0.03|||||||t-test, 2 sided|||To compare WOMAC at 6-months between both groups.||||0.030
72438325|NCT02527148|144389972|SUPERIORITY|||||||0.131|||||||t-test, 2 sided|||To compare WOMAC at 1-year between both groups.||||0.131
72495287|NCT01665144|144519588|SUPERIORITY||Hazard Ratio (HR)|0.8|||||TWO_SIDED|95.0|0.53|1.19|||Cox proportional hazard model|||With superimposed relapses post-treatment||1.19|0.53|
72495288|NCT01665144|144519589|SUPERIORITY||Hazard Ratio (HR)|0.65|||||TWO_SIDED|95.0|0.46|0.91|||Cox proportional hazard model|||Rapidly evolving patients||0.91|0.46|
72438326|NCT02527148|144389972|SUPERIORITY|||||||0.347|||||||t-test, 2 sided|||To compare WOMAC at 2-years between both groups.||||0.347
72495289|NCT01665144|144519589|SUPERIORITY||Hazard Ratio (HR)|0.86|||||TWO_SIDED|95.0|0.69|1.09|||Cox proportional hazard model|||Not rapidly evolving patients||1.09|0.69|
72495290|NCT01665144|144519590|SUPERIORITY||Hazard Ratio (HR)|0.8|||||TWO_SIDED|95.0|0.65|0.99|||Cox proportional hazard model|||With moderate or severe course of disease||0.99|0.65|
72495291|NCT01665144|144519590|SUPERIORITY||Hazard Ratio (HR)|0.73|||||TWO_SIDED|95.0|0.47|1.13|||Cox proportional hazard model|||Without moderate or severe course of disease||1.13|0.47|
72495292|NCT01913483|144519599|SUPERIORITY|||||||0.9458||||||The primary endpoint analysis was to assess the superiority of bivalirudin versus UFH in BARC ≥3 bleeds within the 48 hours post study drug initiation or at hospital discharge, whichever occurred first.|Chi-squared|||Assuming a bleeding event rate of 5.0% in the heparin control treatment group and 3.2% in the bivalirudin group (36% relative risk reduction, a sample size of 3900 participants was to provide more than 80% power with a two-tailed alpha level of 0.05). This estimate took into consideration that the interim efficacy analysis was to be performed when approximately 70% of participants were enrolled using the O'Brien-Fleming alpha spending function.||||0.9458
72438327|NCT02527148|144389972|SUPERIORITY|||||||0.341|||||||t-test, 2 sided|||To compare WOMAC at 5-years between both groups.||||0.341
72438328|NCT02527148|144389973|SUPERIORITY|||||||0.452|||||||t-test, 2 sided|||To compare EQ-5D index preoperatively between both groups.||||0.452
72385833|NCT01346969|144279067|OTHER|LS Mean, SE, 95% confidence interval, and p-value were derived from MMRM model that includes fixed factors for treatment, pooled site, scheduled visit, an interaction for treatment by scheduled visit, and a covariate for Fitzpatrick category.|LS Mean|-0.4|STANDARD_ERROR_OF_MEAN|0.54||0.427|TWO_SIDED|95.0|-1.5|0.6|||Mixed Models Analysis|||Surface Area: Intraparticipant analysis||0.6|-1.5|0.427
72385834|NCT01346969|144279067|OTHER|LS Mean, SE, 95% confidence interval, and p-value were derived from MMRM model that includes fixed factors for treatment, pooled site, scheduled visit, an interaction for treatment by scheduled visit, and a covariate for Fitzpatrick category.|LS Mean|-3.1|STANDARD_ERROR_OF_MEAN|2.7||0.256|TWO_SIDED|95.0|-8.4|2.2|||Mixed Models Analysis|||Composite Score: Intraparticipant analysis||2.2|-8.4|0.256
72385835|NCT01346969|144279067|OTHER|LS Mean, SE, 95% confidence interval, and p-value were derived from MMRM model that includes fixed factors for treatment, pooled site, scheduled visit, an interaction for treatment by scheduled visit, and a covariate for Fitzpatrick category.|LS Mean|0.8|STANDARD_ERROR_OF_MEAN|0.62||0.198|TWO_SIDED|95.0|-0.4|2.0|||Mixed Models Analysis|||Overall Opinion: Intraparticipant analysis||2.0|-0.4|0.198
72385836|NCT01346969|144279067|OTHER|LS Mean, SE, 95% confidence interval, and p-value were derived from MMRM model that includes fixed factors for treatment, pooled site, scheduled visit, an interaction for treatment by scheduled visit, and a covariate for Fitzpatrick category.|LS Mean|0.9|STANDARD_ERROR_OF_MEAN|0.6||0.132|TWO_SIDED|95.0|-0.3|2.1|||Mixed Models Analysis|||Vascularity: Intraparticipant analysis||2.1|-0.3|0.132
72385837|NCT01346969|144279067|OTHER|LS Mean, SE, 95% confidence interval, and p-value were derived from MMRM model that includes fixed factors for treatment, pooled site, scheduled visit, an interaction for treatment by scheduled visit, and a covariate for Fitzpatrick category.|LS Mean|0.7|STANDARD_ERROR_OF_MEAN|0.58||0.227|TWO_SIDED|95.0|-0.4|1.8|||Mixed Models Analysis|||Pigmentation: Intraparticipant analysis||1.8|-0.4|0.227
72385838|NCT01346969|144279067|OTHER|LS Mean, SE, 95% confidence interval, and p-value were derived from MMRM model that includes fixed factors for treatment, pooled site, scheduled visit, an interaction for treatment by scheduled visit, and a covariate for Fitzpatrick category.|LS Mean|0.8|STANDARD_ERROR_OF_MEAN|0.63||0.208|TWO_SIDED|95.0|-0.4|2.0|||Mixed Models Analysis|||Thickness: Intraparticipant analysis||2.0|-0.4|0.208
72385839|NCT01346969|144279067|OTHER|LS Mean, SE, 95% confidence interval, and p-value were derived from MMRM model that includes fixed factors for treatment, pooled site, scheduled visit, an interaction for treatment by scheduled visit, and a covariate for Fitzpatrick category.|LS Mean|0.7|STANDARD_ERROR_OF_MEAN|0.63||0.265|TWO_SIDED|95.0|-0.5|1.9|||Mixed Models Analysis|||Relief: Intraparticipant analysis||1.9|-0.5|0.265
72385840|NCT01346969|144279067|OTHER|LS Mean, SE, 95% confidence interval, and p-value were derived from MMRM model that includes fixed factors for treatment, pooled site, scheduled visit, an interaction for treatment by scheduled visit, and a covariate for Fitzpatrick category.|LS Mean|0.6|STANDARD_ERROR_OF_MEAN|0.63||0.34|TWO_SIDED|95.0|-0.6|1.8|||Mixed Models Analysis|||Pliability: Intraparticipant analysis||1.8|-0.6|0.340
72385841|NCT01346969|144279067|OTHER|LS Mean, SE, 95% confidence interval, and p-value were derived from MMRM model that includes fixed factors for treatment, pooled site, scheduled visit, an interaction for treatment by scheduled visit, and a covariate for Fitzpatrick category.|LS Mean|0.6|STANDARD_ERROR_OF_MEAN|0.64||0.347|TWO_SIDED|95.0|-0.7|1.9|||Mixed Models Analysis|||Surface Area: Intraparticipant analysis||1.9|-0.7|0.347
72385842|NCT01346969|144279067|OTHER|LS Mean, SE, 95% confidence interval, and p-value were derived from MMRM model that includes fixed factors for treatment, pooled site, scheduled visit, an interaction for treatment by scheduled visit, and a covariate for Fitzpatrick category.|LS Mean|4.3|STANDARD_ERROR_OF_MEAN|3.19||0.179|TWO_SIDED|95.0|-2.0|10.6|||Mixed Models Analysis|||Composite Score: Intraparticipant analysis||10.6|-2.0|0.179
72385843|NCT01346969|144279067|OTHER|LS Mean, SE, 95% confidence interval, and p-value were derived from MMRM model that includes fixed factors for treatment, pooled site, scheduled visit, an interaction for treatment by scheduled visit, and a covariate for Fitzpatrick category.|Least Square (LS) Mean|-0.3|STANDARD_ERROR_OF_MEAN|0.57||0.556|TWO_SIDED|95.0|-1.4|0.8|||Mixed Models Analysis|||Overall Opinion: Intraparticipant analysis||0.8|-1.4|0.556
72385844|NCT01346969|144279067|OTHER|LS Mean, SE, 95% confidence interval, and p-value were derived from MMRM model that includes fixed factors for treatment, pooled site, scheduled visit, an interaction for treatment by scheduled visit, and a covariate for Fitzpatrick category.|LS Mean|-0.2|STANDARD_ERROR_OF_MEAN|0.54||0.76|TWO_SIDED|95.0|-1.2|0.9|||Mixed Models Analysis|||Vascularity: Intraparticipant analysis||0.9|-1.2|0.760
72385845|NCT01346969|144279067|OTHER|LS Mean, SE, 95% confidence interval, and p-value were derived from MMRM model that includes fixed factors for treatment, pooled site, scheduled visit, an interaction for treatment by scheduled visit, and a covariate for Fitzpatrick category.|LS Mean|-0.3|STANDARD_ERROR_OF_MEAN|0.53||0.636|TWO_SIDED|95.0|-1.3|0.8|||Mixed Models Analysis|||Pigmentation: Intraparticipant analysis||0.8|-1.3|0.636
72385846|NCT01346969|144279067|OTHER|LS Mean, SE, 95% confidence interval, and p-value were derived from MMRM model that includes fixed factors for treatment, pooled site, scheduled visit, an interaction for treatment by scheduled visit, and a covariate for Fitzpatrick category.|LS Mean|-0.2|STANDARD_ERROR_OF_MEAN|0.58||0.774|TWO_SIDED|95.0|-1.3|1.0|||Mixed Models Analysis|||Thickness: Intraparticipant analysis||1.0|-1.3|0.774
72385847|NCT01346969|144279067|OTHER|LS Mean, SE, 95% confidence interval, and p-value were derived from MMRM model that includes fixed factors for treatment, pooled site, scheduled visit, an interaction for treatment by scheduled visit, and a covariate for Fitzpatrick category.|LS Mean|-0.2|STANDARD_ERROR_OF_MEAN|0.57||0.771|TWO_SIDED|95.0|-1.3|1.0|||Mixed Models Analysis|||Relief: Intraparticipant analysis||1.0|-1.3|0.771
72385848|NCT01346969|144279067|OTHER|LS Mean, SE, 95% confidence interval, and p-value were derived from MMRM model that includes fixed factors for treatment, pooled site, scheduled visit, an interaction for treatment by scheduled visit, and a covariate for Fitzpatrick category.|LS Mean|-0.4|STANDARD_ERROR_OF_MEAN|0.57||0.468|TWO_SIDED|95.0|-1.5|0.7|||Mixed Models Analysis|||Pliability: Intraparticipant analysis||0.7|-1.5|0.468
72438329|NCT02527148|144389973|SUPERIORITY|||||||0.201|||||||t-test, 2 sided|||To compare EQ-5D VAS preoperatively between both groups.||||0.201
72438330|NCT02527148|144389973|SUPERIORITY|||||||0.741|||||||t-test, 2 sided|||To compare EQ-5D index at 6-weeks between both groups.||||0.741
72438331|NCT02527148|144389973|SUPERIORITY|||||||0.794|||||||t-test, 2 sided|||To compare EQ-5D VAS at 6-weeks between both groups.||||0.794
72385849|NCT01346969|144279067|OTHER|LS Mean, SE, 95% confidence interval, and p-value were derived from MMRM model that includes fixed factors for treatment, pooled site, scheduled visit, an interaction for treatment by scheduled visit, and a covariate for Fitzpatrick category.|LS Mean|-0.1|STANDARD_ERROR_OF_MEAN|0.58||0.886|TWO_SIDED|95.0|-1.2|1.1|||Mixed Models Analysis|||Surface Area: Intraparticipant analysis||1.1|-1.2|0.886
72385850|NCT01346969|144279067|OTHER|LS Mean, SE, 95% confidence interval, and p-value were derived from MMRM model that includes fixed factors for treatment, pooled site, scheduled visit, an interaction for treatment by scheduled visit, and a covariate for Fitzpatrick category.|LS Mean|-1.3|STANDARD_ERROR_OF_MEAN|2.91||0.668|TWO_SIDED|95.0|-7.0|4.5|||Mixed Models Analysis|||Composite Score: Intraparticipant analysis||4.5|-7.0|0.668
72385851|NCT05736224|144279167|SUPERIORITY|||||||0.003||||||No sunscreen compared to test sunscreen|t-test, 2 sided|||||||0.003
72395133|NCT02289690|144296702|SUPERIORITY||Odds Ratio (OR)|0.8||||0.604|TWO_SIDED|80.0|0.5|1.3|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by LDH level.|Odds ratio was from a Cochran-Mantel-Haenszel test stratified by LDH level. An odds ratio of \> 1 favors veliparib in combination with carboplatin and etoposide followed by placebo maintenance monotherapy (Arm B).|"If the primary analysis of PFS (Arm A vs Arm C) was statistically significant a fixed sequence testing procedure was to be performed with a 2-sided significance level of 0.2 for the following key secondary endpoints:~1. OS (Arm A vs Arm C)~2. PFS (Arms B vs Arm C)~3. OS (Arm B vs Arm C)~4. ORR (Arm A vs Arm C)~5. ORR (Arm B vs Arm C)~If significance versus Arm C was not demonstrated, all endpoints later in the testing hierarchy were to be considered exploratory."||1.3|0.5|0.604
72395134|NCT02730455|144296809|SUPERIORITY||Odds Ratio (OR)|0.64||||0.086|TWO_SIDED|95.0|0.38|1.07|||Regression, Logistic|||Composite Measure: The global odds ratio was based on a linear logistic regression model with baseline National Institute of Health Stroke Scale (NIHSS) category (score 5-15, 16-23), age (\<60, 60-69, 70-80), tissue plasminogen activator (tPA) use (yes/no), treatment window (\<=9, \>9 and \<=24hours), thrombectomy (yes/no) and region (Spain, UK/Germany, United States of America \[USA\]) as covariates and unstructured working correlation structure||1.07|0.38|0.086
72395135|NCT02730455|144296809|SUPERIORITY||Odds Ratio (OR)|0.57||||0.031|TWO_SIDED|95.0|0.34|0.95|||Regression, Logistic|||Composite Measure: The global odds ratio was based on a linear logistic regression model with baseline NIHSS category (score 5-15, 16-23), age (\<60, 60-69, 70-80), tPA use (yes/no), treatment window (\<=9, \>9 and \<=24hours), thrombectomy (yes/no) and region (Spain, UK/Germany, USA) as covariates and unstructured working correlation structure||0.95|0.34|0.031
72395136|NCT02730455|144296810|SUPERIORITY||Odds Ratio (OR)|0.67||||0.222|TWO_SIDED|95.0|0.35|1.28|||Regression, Logistic|||The odds ratio was based on a linear logistic regression model with baseline NIHSS category (score 5-15, 16-23), age (\<60, 60-69, 70-80), tPA use (yes/no), treatment window (\<=9, \>9 and \<=24hours), thrombectomy (yes/no) and region (Spain, UK/Germany, USA) as covariates and unstructured working correlation structure||1.28|0.35|0.222
72395137|NCT02730455|144296810|SUPERIORITY||Odds Ratio (OR)|0.54||||0.073|TWO_SIDED|95.0|0.28|1.06|||Regression, Logistic|||The odds ratio was based on a linear logistic regression model with baseline NIHSS category (score 5-15, 16-23), age (\<60, 60-69, 70-80), tPA use (yes/no), treatment window (\<=9, \>9 and \<=24hours), thrombectomy (yes/no) and region (Spain, UK/Germany, USA) as covariates and unstructured working correlation structure||1.06|0.28|0.073
72395138|NCT02730455|144296811|SUPERIORITY||Odds Ratio (OR)|0.56||||0.085|TWO_SIDED|95.0|0.29|1.08|||Regression, Logistic|||The odds ratio was based on a linear logistic regression model with baseline NIHSS category (score 5-15, 16-23), age (\<60, 60-69, 70-80), tPA use (yes/no), treatment window (\<=9, \>9 and \<=24hours), thrombectomy (yes/no) and region (Spain, UK/Germany, USA) as covariates and unstructured working correlation structure.||1.08|0.29|0.085
72395139|NCT02730455|144296811|SUPERIORITY||Odds Ratio (OR)|0.54||||0.067|TWO_SIDED|95.0|0.28|1.04|||Regression, Logistic|||The odds ratio was based on a linear logistic regression model with baseline NIHSS category (score 5-15, 16-23), age (\<60, 60-69, 70-80), tPA use (yes/no), treatment window (\<=9, \>9 and \<=24hours), thrombectomy (yes/no) and region (Spain, UK/Germany, USA) as covariates and unstructured working correlation structure.||1.04|0.28|0.067
72395140|NCT02730455|144296812|SUPERIORITY||Adjusted Mean Difference|-7.7||||0.106|TWO_SIDED|95.0|-16.97|1.64|||Mixed-effects model for repeated measure|||Treatment and treatment by visit interaction were included in the model as explanatory variables. Baseline NIHSS category (score 5-15, 16-23), tPA use (yes/no), age (\<60, 60-69, 70-80), thrombectomy (yes/no), region (Spain, UK/Germany, USA) and treatment window were considered as covariates. An unstructured variance-covariance matrix was used in the model.||1.64|-16.97|0.106
72395141|NCT02730455|144296812|SUPERIORITY||Adjusted Mean Difference|-6.1||||0.202|TWO_SIDED|95.0|-15.43|3.27|||Mixed-effects model for repeated measure|||Treatment and treatment by visit interaction were included in the model as explanatory variables. Baseline NIHSS category (score 5-15, 16-23), tPA use (yes/no), age (\<60, 60-69, 70-80), thrombectomy (yes/no), region (Spain, UK/Germany, USA) and treatment window were considered as covariates. An unstructured variance-covariance matrix was used in the model.||3.27|-15.43|0.202
72395142|NCT02730455|144296813|SUPERIORITY||Adjusted Mean Difference|-0.3||||0.78|TWO_SIDED|95.0|-2.64|1.99|||Mixed-effects model for repeated measure|||Treatment and treatment by visit interaction were included in the model as explanatory variables. Baseline NIHSS category (score 5-15, 16-23), tPA use (yes/no), age (\<60, 60-69, 70-80), thrombectomy (yes/no), region (Spain, UK/Germany, USA) and treatment window were considered as covariates. An unstructured variance-covariance matrix was used in the model.||1.99|-2.64|0.780
72438332|NCT02527148|144389973|SUPERIORITY|||||||0.232|||||||t-test, 2 sided|||To compare EQ-5D index at 6-months between both groups.||||0.232
72438333|NCT02527148|144389973|SUPERIORITY|||||||0.513|||||||t-test, 2 sided|||To compare EQ-5D VAS at 6-months between both groups.||||0.513
72438334|NCT02527148|144389973|SUPERIORITY|||||||0.18|||||||t-test, 2 sided|||To compare EQ-5D index at 1-year between both groups.||||0.180
72438335|NCT02527148|144389973|SUPERIORITY|||||||0.864|||||||t-test, 2 sided|||To compare EQ-5D VAS at 1-year between both groups.||||0.864
72438336|NCT02527148|144389973|SUPERIORITY|||||||0.223|||||||t-test, 2 sided|||To compare EQ-5D index at 2-year between both groups.||||0.223
72438337|NCT02527148|144389973|SUPERIORITY|||||||0.355|||||||t-test, 2 sided|||To compare EQ-5D VAS at 2-year between both groups.||||0.355
72438338|NCT02527148|144389973|SUPERIORITY|||||||0.314|||||||t-test, 2 sided|||To compare EQ-5D index at 5-year between both groups.||||0.314
72438339|NCT02527148|144389973|SUPERIORITY|||||||0.914|||||||t-test, 2 sided|||To compare EQ-5D VAS at 5-year between both groups.||||0.914
72438340|NCT02527148|144389974|SUPERIORITY|||||||0.523|||||||t-test, 2 sided|||To compare FJS at 6-weeks between both groups.||||0.523
72438341|NCT02527148|144389974|SUPERIORITY|||||||0.932|||||||t-test, 2 sided|||To compare FJS at 6-months between both groups.||||0.932
72438342|NCT02527148|144389974|SUPERIORITY|||||||0.934|||||||t-test, 2 sided|||To compare FJS at 1-year between both groups.||||0.934
72438343|NCT02527148|144389974|SUPERIORITY|||||||0.566|||||||t-test, 2 sided|||To compare FJS at 2-year between both groups.||||0.566
72385852|NCT03319173|144279176|OTHER||Mean Difference (Final Values)|8.24|STANDARD_ERROR_OF_MEAN|0.23|<|0.0001|TWO_SIDED|95.0|7.79|8.7|||Regression, Linear|||||8.7|7.79|<0.0001
72385853|NCT03319173|144279177|OTHER||Estimate|0.35|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001|TWO_SIDED|95.0|0.31|0.39|||Regression, Linear|||||0.39|0.31|<0.0001
72385854|NCT03319173|144279178|OTHER||Estimate|0.46|STANDARD_ERROR_OF_MEAN|0.03|<|0.0001|TWO_SIDED|95.0|0.41|0.52|||Regression, Linear|||||0.52|0.41|<0.0001
72385855|NCT03319173|144279179|OTHER||Estimate|0.514|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001|TWO_SIDED|95.0|0.47|0.56|||Regression, Linear|||||0.56|0.47|<0.0001
72385856|NCT03319173|144279180|OTHER||Estimate|0.44|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001|TWO_SIDED|95.0|0.4|0.49|||Regression, Linear|||||0.49|0.40|<0.0001
72385857|NCT03319173|144279181|OTHER||Mean Difference (Final Values)|0.44|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001|TWO_SIDED|95.0|0.4|0.49|||Estimate|||||0.49|0.40|<0.0001
72618860|NCT03931785|144768272|SUPERIORITY||Difference in Responder Rate|-7.2|||||TWO_SIDED|95.0|-21.2|6.8|||||Difference in responder rate (MD-7246 - placebo). 95% CIs for differences in responder rates were obtained using the normal approximation to the binomial distribution.|||6.8|-21.2|
72618861|NCT03931785|144768272|SUPERIORITY||Odds Ratio (OR)|1.043||||0.8852|TWO_SIDED|95.0|0.591|1.839|||Cochran-Mantel-Haenszel||Odds ratio for response (MD-7246 : placebo)|||1.839|0.591|0.8852
72385858|NCT03319173|144279182|OTHER||Estimate|0.75|STANDARD_ERROR_OF_MEAN|0.01|<|0.0001|TWO_SIDED|95.0|0.72|0.78|||Regression, Linear|||||0.78|0.72|<0.0001
72385859|NCT03319173|144279183|OTHER||Mean Difference (Final Values)|0.33|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001|TWO_SIDED|95.0|0.3|0.37|||Estimate|||||0.37|0.30|<0.0001
72385860|NCT03319173|144279184|OTHER||Estimate|0.87|STANDARD_ERROR_OF_MEAN|0.01|<|0.0001|TWO_SIDED|95.0|0.85|0.88|||Regression, Linear|||||0.88|0.85|<0.0001
72385861|NCT03319173|144279185|OTHER||Estimate|0.87|STANDARD_ERROR_OF_MEAN|0.01|<|0.0001|TWO_SIDED|95.0|0.85|0.88|||Regression, Linear|||||0.88|0.85|<0.0001
72385862|NCT03319173|144279186|OTHER||Estimate|0.75|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001|TWO_SIDED|95.0|0.71|0.8|||Regression, Linear|||||0.80|0.71|<0.0001
72385863|NCT03319173|144279187|OTHER||Estimate|0.51|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001|TWO_SIDED|95.0|0.47|0.56|||Regression, Linear|||||0.56|0.47|<0.0001
72385864|NCT03319173|144279188|OTHER||Estimate|1.13|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|1.104|1.156|||Regression, Linear|||||1.156|1.104|<0.0001
72385865|NCT03319173|144279189|OTHER||Estimate|1.037|||<|0.0001|TWO_SIDED|95.0|1.025|1.049|||Regression, Linear|||||1.049|1.025|<0.0001
72385866|NCT03319173|144279190|OTHER||Estimate|0.93|STANDARD_ERROR_OF_MEAN|0.008|<|0.0001|TWO_SIDED|95.0|0.91|0.94|||Regression, Linear|||||0.94|0.91|<0.0001
72385867|NCT03319173|144279191|OTHER||Estimate|1.122|STANDARD_ERROR_OF_MEAN|0.014|<|0.0001|TWO_SIDED|95.0|1.096|1.149|||Regression, Linear|||||1.149|1.096|<0.0001
72385868|NCT03673046|144279192|SUPERIORITY||Mean Difference (Final Values)|-10.1255|STANDARD_ERROR_OF_MEAN|1.5705|<|0.0001|TWO_SIDED|95.0|-13.2532|-6.9978||The p-value was not adjusted for multiple comparisons because this was the pre-specified primary endpoint comparison. The a priori threshold for statistical significance was alpha=.05.|Mixed Models Analysis|Repeated measures were modeled with a compound symmetry with heterogeneous variance covariance matrix.|The effect is presented as the Smartphone-delivered CBT for BDD group outcome compared to the 12-eeek waitlist control group outcome at the trial end-point (week 12).|Null hypothesis: there is no significant difference in BDD-YBOCS total scores between the treatment groups at endpoint (week 12).||-6.9978|-13.2532|<.0001
72438344|NCT02527148|144389974|SUPERIORITY|||||||0.263|||||||t-test, 2 sided|||To compare FJS at 5-year between both groups.||||0.263
72385869|NCT03673046|144279193|SUPERIORITY||Mean Difference (Final Values)|-3.2648|STANDARD_ERROR_OF_MEAN|1.0346||0.0023|TWO_SIDED|95.0|-5.3275|-1.2022||The p-value was not adjusted for multiple comparisons because this was a pre-specified secondary endpoint comparison. The a priori threshold for statistical significance was alpha=.05.|Mixed Models Analysis|Repeated measures were modeled with an auto-correlation with heterogeneous variance (ARH(1)) covariance matrix.|The effect is presented as the Smartphone-delivered CBT for BDD group outcome compared to the 12-week waitlist control group outcome at the trial end-point (week 12).|Null hypothesis: there is no significant difference in QIDS-SR total scores between the treatment groups at endpoint (week 12).||-1.2022|-5.3275|0.0023
72438345|NCT02527148|144389975|SUPERIORITY|||||||0.3768|||||||t-test, 2 sided|||To compare IKSS Pain preoperatively between both groups.||||0.3768
72438346|NCT02527148|144389975|SUPERIORITY|||||||0.6425|||||||t-test, 2 sided|||To compare IKSS Function preoperatively between both groups.||||0.6425
72438347|NCT02527148|144389975|SUPERIORITY|||||||0.5041|||||||t-test, 2 sided|||To compare IKSS ROM preoperatively between both groups.||||0.5041
72438348|NCT02527148|144389975|SUPERIORITY|||||||0.223|||||||t-test, 2 sided|||To compare IKSS Pain at 6-weeks between both groups.||||0.2230
72438349|NCT02527148|144389975|SUPERIORITY|||||||0.8209|||||||t-test, 2 sided|||To compare IKSS Function at 6-weeks between both groups.||||0.8209
72438350|NCT02527148|144389975|SUPERIORITY|||||||0.6958|||||||t-test, 2 sided|||To compare IKSS ROM at 6-weeks between both groups.||||0.6958
72438351|NCT02527148|144389975|SUPERIORITY|||||||0.0548|||||||t-test, 2 sided|||To compare IKSS Pain at 6-months between both groups.||||0.0548
72438352|NCT02527148|144389975|SUPERIORITY|||||||0.1958|||||||t-test, 2 sided|||To compare IKSS Function at 6-months between both groups.||||0.1958
72438353|NCT02527148|144389975|SUPERIORITY|||||||0.2786|||||||t-test, 2 sided|||To compare IKSS ROM at 6-months between both groups.||||0.2786
72438354|NCT02527148|144389975|SUPERIORITY|||||||0.2399|||||||t-test, 2 sided|||To compare IKSS Pain at 1-year between both groups.||||0.2399
72438355|NCT02527148|144389975|SUPERIORITY|||||||0.4135|||||||t-test, 2 sided|||To compare IKSS Function at 1-year between both groups.||||0.4135
72438356|NCT02527148|144389975|SUPERIORITY|||||||0.5278|||||||t-test, 2 sided|||To compare IKSS ROM at 1-year between both groups.||||0.5278
72618862|NCT03931785|144768272|SUPERIORITY||Odds Ratio (OR)|0.634||||0.1152|TWO_SIDED|95.0|0.36|1.117|||Cochran-Mantel-Haenszel||Odds ratio for response (MD-7246 : placebo)|||1.117|0.360|0.1152
72385870|NCT03673046|144279194|SUPERIORITY||Mean Difference (Final Values)|-4.8412|STANDARD_ERROR_OF_MEAN|1.1195|<|0.0001|TWO_SIDED|95.0|-7.0698|-2.6126||The p-value was not adjusted for multiple comparisons because this was a pre-specified secondary endpoint comparison. The a priori threshold for statistical significance was alpha=.05.|Mixed Models Analysis|Repeated measures were modeled with a compound symmetry with heterogeneous variance covariance matrix.|The effect is presented as the Smartphone-delivered CBT for BDD group outcome compared to the 12-week waitlist control group outcome at the trial end-point (week 12).|Null hypothesis: there is no significant difference in BABS total scores between the treatment groups at endpoint (week 12).||-2.6126|-7.0698|<.0001
72385871|NCT03673046|144279195|SUPERIORITY||Mean Difference (Final Values)|-5.8847|STANDARD_ERROR_OF_MEAN|1.676||0.0008|TWO_SIDED|95.0|-9.2237|-2.5458||The p-value was not adjusted for multiple comparisons because this was a pre-specified secondary endpoint comparison. The a priori threshold for statistical significance was alpha=.05.|Mixed Models Analysis|Repeated measures were modeled with an auto-correlation with heterogeneous variance (ARH(1)) covariance matrix.|The effect is presented as the Smartphone-delivered CBT for BDD group outcome compared to the 12-week waitlist control group outcome at the trial end-point (week 12).|Null hypothesis: there is no significant difference in SDS total scores between the treatment groups at endpoint (week 12).||-2.5458|-9.2237|.0008
72385872|NCT03673046|144279196|SUPERIORITY||Mean Difference (Final Values)|11.7529|STANDARD_ERROR_OF_MEAN|3.4553||0.0011|TWO_SIDED|95.0|4.863|18.6428||The p-value was not adjusted for multiple comparisons because this was a pre-specified secondary endpoint comparison. The a priori threshold for statistical significance was alpha=.05.|Mixed Models Analysis|Repeated measures were modeled with a compound symmetry with heterogeneous variance covariance matrix.|The effect is presented as the Smartphone-delivered CBT for BDD group outcome compared to the 12-week waitlist control group outcome at the trial end-point (week 12).|Null hypothesis: there is no significant difference in Q-LESQ-SF total scores between the treatment groups at endpoint (week 12).||18.6428|4.8630|.0011
72385873|NCT01896050|144279205|SUPERIORITY_OR_OTHER|||||||0.03|||||||Wilcoxon (Mann-Whitney)|||Compare difference in change in body mass index between baseline and 12 months between aromatase inhibitor- and tamoxifen-treated patients||||0.03
72385874|NCT01896050|144279205|SUPERIORITY_OR_OTHER||BMI squared|-0.01845|STANDARD_ERROR_OF_MEAN|0.02308||0.4262|TWO_SIDED||||||Regression, Linear|||Examine association between change in body mass index and change in grip strength with aromatase inhibitor therapy. For the primary outcome, linear regression was used for analysis with change of grip strength as response variable. In the original statistical analysis plan only aromatase inhibitor-treated patients were to be included in this analysis. This analysis was not performed on the tamoxifen group because it isn't clinically relevant.||||0.4262
72385875|NCT01896050|144279206|SUPERIORITY_OR_OTHER|||||||0.032|||||||Wilcoxon (Mann-Whitney)|||Comparison of change in maximum grip strength between baseline and 12 months for aromatase inhibitor-treated versus tamoxifen-treated patients||||0.032
72385876|NCT01896050|144279207|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.98|||||TWO_SIDED|95.0|0.92|1.04||||||Association between baseline body mass index and discontinuation of aromatase inhibitor therapy. The original statistical analysis plan only called for analyzing the aromatase inhibitor-treated patients, not the tamoxifen-treated patients.||1.04|0.92|
72385877|NCT03693300|144279217|OTHER||Proportion (%)|6.1|||||TWO_SIDED|95.0|2.5|12.24|||||95% CI were based on the Clopper-Pearson method.|Any possibly related adverse events of CTCAE Grade 3 or Grade 4||12.24|2.50|
72385878|NCT03693300|144279217|OTHER||Proportion (%)|0.0|||||TWO_SIDED|95.0|0.0|70.76|||||95% CI were based on the Clopper-Pearson method.|Any possibly related adverse events of CTCAE Grade 3 or Grade 4||70.76|0.00|
72385879|NCT03693300|144279217|OTHER||Proportion (%)|6.0|||||TWO_SIDED|95.0|2.44|11.94|||||95% CI were based on the Clopper-Pearson method.|Any possibly related adverse events of CTCAE Grade 3 or Grade 4||11.94|2.44|
72438357|NCT02527148|144389975|SUPERIORITY|||||||0.2992|||||||t-test, 2 sided|||To compare IKSS Pain at 2-year between both groups.||||0.2992
72438358|NCT02527148|144389975|SUPERIORITY|||||||0.5462|||||||t-test, 2 sided|||To compare IKSS Function at 2-year between both groups.||||0.5462
72438359|NCT02527148|144389975|SUPERIORITY|||||||0.5765|||||||t-test, 2 sided|||To compare IKSS ROM at 2-year between both groups.||||0.5765
72438360|NCT02527148|144389975|SUPERIORITY|||||||0.5493|||||||t-test, 2 sided|||To compare IKSS Pain at 5-year between both groups.||||0.5493
72438361|NCT02527148|144389975|SUPERIORITY|||||||0.1705|||||||t-test, 2 sided|||To compare IKSS Function at 5-year between both groups.||||0.1705
72618863|NCT03931785|144768272|SUPERIORITY||Odds Ratio (OR)|0.749||||0.3157|TWO_SIDED|95.0|0.425|1.317|||Cochran-Mantel-Haenszel||Odds ratio for response (MD-7246 : placebo)|||1.317|0.425|0.3157
72438362|NCT02527148|144389975|SUPERIORITY|||||||0.2918|||||||t-test, 2 sided|||To compare IKSS ROM at 5-year between both groups.||||0.2918
72438363|NCT02527148|144389976|OTHER|||||||0.6|||||||t-test, 2 sided|||Comparison of coronal mechanical axis:hip knee ankle angle between both groups.||||0.6
72438364|NCT02527148|144389976|OTHER|||||||0.002|||||||t-test, 2 sided|||Comparison of coronal angle fem comp and mech axis femur between both groups.||||0.002
72438365|NCT02527148|144389976|OTHER||||||<|0.001|||||||t-test, 2 sided|||Comparison of coronal angle tibial comp and mech axis tibia between both groups.||||<0.001
72495293|NCT02302963|144519602|OTHER|Analysis of Variance|||||<|0.001|||||||GLM Repeated Measures|Repeated-measures general linear model was used to compare HCLC versus SAP data. A P-value of \< 0.001 was considered the threshold for significance.||||||<0.001
72495294|NCT00915343|144519607|SUPERIORITY_OR_OTHER_LEGACY||Period-adjusted quotient|0.806|||<|0.0001|TWO_SIDED|95.0|0.753|0.862||Comparison of log S-cortisol AUC between OD and TID regimens was adjusted for both period effect and subject effect using generalized linear model (GLM) in statistical analysis system (SAS).|ANOVA||The quotient was defined as AUC0-24h for OD treatment divided by AUC0-24h for TID treatment.|||0.862|0.753|<0.0001
72438366|NCT02527148|144389976|OTHER||||||<|0.001|||||||t-test, 2 sided|||Comparison of sagital tibial component slope between both groups.||||<0.001
72438367|NCT02527148|144389976|OTHER||||||<|0.001|||||||t-test, 2 sided|||Comparison of Fem comp rotation relative to surg epicond axis+=ER between both groups.||||<0.001
72438368|NCT01254019|144390019|SUPERIORITY||Mean Difference (Net)|10.334||||0.415|TWO_SIDED|95.0|-14.645|35.312||Statistical significance was assessed at the 5% level.|Mixed Effect Model for Repeated Measures|Model included terms for treatment, visit, treatment by visit, country grouping, Baseline and Baseline by visit.||GSK2402968 6mg/kg/week Vs Placebo||35.312|-14.645|0.415
72438369|NCT01254019|144390020|SUPERIORITY||Mean Difference (Net)|-0.53||||0.757|TWO_SIDED|95.0|-3.95|2.88||Statistical significance (SS) was only to be assessed if a statistically significant difference was observed for the primary and any secondary endpoints higher in the pre-defined hierarchy. Hence conclusions with regards to SS should not be made.|Mixed Effect Model for Repeated Measures|Model included terms for treatment, visit, treatment by visit, country grouping, Baseline and Baseline by visit.||GSK2402968 6mg/kg/week Vs Placebo||2.88|-3.95|0.757
72438370|NCT01254019|144390021|SUPERIORITY||Mean Difference (Net)|-0.021||||0.718|TWO_SIDED|95.0|-0.137|0.095||SS was only to be assessed if a statistically significant difference was observed for the primary and any secondary endpoints higher in the pre-defined hierarchy. Hence conclusions with regards to SS should not be made.|Mixed Effect Model for Repeated Measures|Model included terms for treatment, visit, treatment by visit, country grouping, Baseline and Baseline by visit.||GSK2402968 6mg/kg/week Vs Placebo||0.095|-0.137|0.718
72438371|NCT01254019|144390022|SUPERIORITY||Mean Difference (Net)|-0.009||||0.881|TWO_SIDED|95.0|-0.129|0.111||SS was only to be assessed if a statistically significant difference was observed for the primary and any secondary endpoints higher in the pre-defined hierarchy. Hence conclusions with regards to SS should not be made.|Mixed Effect Model for Repeated Measures|Model included terms for treatment, visit, treatment by visit, country grouping, Baseline and Baseline by visit.||GSK2402968 6mg/kg/week Vs Placebo||0.111|-0.129|0.881
72438372|NCT01254019|144390023|SUPERIORITY||Mean Difference (Net)|-1.115||||0.658|TWO_SIDED|95.0|-6.097|3.866||No adjustment for multiplicity was made, so p-values should not be used to make conclusions with regards to statistical significance.|Mixed Effect Model for Repeated Measures|Model included terms for treatment, visit, treatment by visit, country grouping, Baseline and Baseline by visit.||GSK2402968 6mg/kg/week Vs Placebo||3.866|-6.097|0.658
72438373|NCT01254019|144390024|SUPERIORITY||Mean Difference (Net)|0.041||||0.513|TWO_SIDED|95.0|-0.082|0.164||No adjustment for multiplicity was made, so p-values should not be used to make conclusions with regards to statistical significance.|Mixed Effect Model for Repeated Measures|Model included terms for treatment, visit, treatment by visit, country grouping, Baseline and Baseline by visit.||GSK2402968 6mg/kg/week Vs Placebo||0.164|-0.082|0.513
72438374|NCT01254019|144390025|SUPERIORITY||Mean Difference (Net)|-0.965||||0.769|TWO_SIDED|95.0|-7.446|5.516||No adjustment for multiplicity was made, so p-values should not be used to make conclusions with regards to statistical significance.|Mixed Effect Model for Repeated Measures|Model included terms for treatment, visit, treatment by visit, country grouping, Baseline and Baseline by visit.||GSK2402968 6mg/kg/week Vs Placebo||5.516|-7.446|0.769
72438375|NCT01254019|144390028|SUPERIORITY||Mean Difference (Net)|-4044.99||||0|TWO_SIDED|95.0|-5232.21|-2857.77||No adjustment for multiplicity was made, so p-values should not be used to make conclusions with regards to statistical significance.|Mixed Effect Model for Repeated Measures|Model included terms for treatment, visit, treatment by visit, country grouping, Baseline and Baseline by visit.||GSK2402968 6mg/kg/week Vs Placebo||-2857.77|-5232.21|0.000
72438376|NCT01254019|144390034|SUPERIORITY||Mean Difference (Net)|0.0288||||0.207|TWO_SIDED|95.0|-0.0161|0.0738||No adjustment for multiplicity was made, so p-values should not be used to make conclusions with regards to statistical significance.|Mixed Model for Repeated Measures|Model included terms for treatment, visit, treatment by visit, country grouping, Baseline and Baseline by visit.||GSK2402968 6mg/kg/week Vs Placebo, HUI2 at Week 48||0.0738|-0.0161|0.207
72438377|NCT01254019|144390034|SUPERIORITY||Mean Difference (Net)|0.0048||||0.88|TWO_SIDED|95.0|-0.058|0.0676||No adjustment for multiplicity was made, so p-values should not be used to make conclusions with regards to statistical significance.|Mixed Model for Repeated Measures|Model included terms for treatment, visit, treatment by visit, country grouping, Baseline and Baseline by visit.||GSK2402968 6mg/kg/week Vs Placebo, HUI3 at Week 48||0.0676|-0.0580|0.880
72438378|NCT03061474|144390043|SUPERIORITY|||||||0.6096|||||||ANCOVA|||||||0.6096
72438379|NCT03061474|144390053|SUPERIORITY|||||||0.648|||||||ANCOVA|||||||0.648
72438380|NCT03061474|144390054|SUPERIORITY|||||||0.6833|||||||ANCOVA|||||||0.6833
72438381|NCT03061474|144390055|SUPERIORITY|||||||0.4438|||||||ANCOVA|||||||0.4438
72438382|NCT03061474|144390056|SUPERIORITY|||||||0.7158|||||||ANCOVA|||||||0.7158
72495295|NCT00915343|144519608|SUPERIORITY_OR_OTHER_LEGACY||Mean difference|-111.989|||<|0.0001|TWO_SIDED|95.0|-133.98|89.999|||Fisher's non-parametric permutation test|||||89.999|-133.980|<0.0001
72438383|NCT03061474|144390057|SUPERIORITY|||||||0.93428359|||||||ANCOVA|||||||0.93428359
72438384|NCT03061474|144390058|SUPERIORITY|||||||0.9931|||||||ANCOVA|||||||0.9931
72438385|NCT03061474|144390059|SUPERIORITY|||||||0.3233|||||||Mixed Models Analysis|||||||0.3233
72438386|NCT03061474|144390060|SUPERIORITY|||||||0.1008|||||||Mixed Models Analysis|||||||0.1008
72438387|NCT03061474|144390061|SUPERIORITY|||||||0.0323|||||||Mixed Models Analysis|||||||0.0323
72438388|NCT00666276|144390079|SUPERIORITY_OR_OTHER||||||=|0.712|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Gender. The null hypothesis is there is no difference between males and females in the incidence rate of ADRs."||||=0.712
72438389|NCT00666276|144390080|SUPERIORITY_OR_OTHER||||||=|0.257|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Age. The null hypothesis is there is no difference between over 65 and less than 65 in the incidence rate of ADRs."||||=0.257
72438390|NCT00666276|144390081|SUPERIORITY_OR_OTHER||||||=|0.082|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Hepatic dysfunctions. The null hypothesis is there is no difference between with Hepatic dysfunction and without Hepatic dysfunction in the incidence rate of ADRs."||||=0.082
72438391|NCT00666276|144390082|SUPERIORITY_OR_OTHER||||||=|0.462|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Renal dysfunctions. The null hypothesis is there is no difference between with Renal dysfunction and without Renal dysfunction in the incidence rate of ADRs."||||=0.462
72438392|NCT00666276|144390083|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Duration of drug administration. The null hypothesis is there is no difference between over 15 days and less than 15 days in the incidence rate of ADRs."||||<0.001
72438393|NCT00666276|144390084|SUPERIORITY_OR_OTHER||||||=|0.018|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Route of administration. The null hypothesis is there is no difference between oral, injection and switch in the incidence rate of ADRs."||||=0.018
72618864|NCT02504775|144768273|NON_INFERIORITY_OR_EQUIVALENCE|Log-transformed PK parameter was compared between products using a linear mixed effects model including terms for product, period, sequence as fixed effect and subject nested within sequence as random effect. Bioequivalence was concluded, when the 90% confidence interval (CI) for the geometric LS mean ratios were fully contained within the predefined equivalence limits of 0.80 to 1.25|Ratio of Averages of Tylenol/Mejoral|94.704|||||TWO_SIDED|90.0|88.329|101.54|||ANOVA|||||101.540|88.329|
72438394|NCT00666276|144390085|SUPERIORITY_OR_OTHER||||||=|0.311|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Weight. The null hypothesis is there is no difference between over 40kg and less than 40kg in the incidence rate of ADRs."||||=0.311
72438395|NCT00666276|144390086|SUPERIORITY_OR_OTHER||||||=|0.044|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Concomitant drugs. The null hypothesis is there is no difference between with Concomitant drug and without Concomitant drug in the incidence rate of ADRs."||||=0.044
72438396|NCT00666276|144390087|SUPERIORITY_OR_OTHER||||||=|0.008|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Non-drug therapies. The null hypothesis is there is no difference between with Non-drug therapies and without Non-drug therapies in the incidence rate of ADRs."||||=0.008
72438397|NCT03299816|144390097|SUPERIORITY|||||||0.17||||||The a priori threshold for statistical significance was \<0.05|Mixed effects regression|Urinary albumin-to-creatinine ratio (ACR) was not normally distributed and was natural log transformed for analyses||||||0.17
72438398|NCT03299816|144390098|SUPERIORITY|||||||0.36||||||The a priori threshold for statistical significance was \<0.05|Mixed effects regression|||||||0.36
72438399|NCT03299816|144390099|SUPERIORITY|||||||0.33||||||The a priori threshold for statistical significance was \<0.05|Mixed effects regression|||||||0.33
72438400|NCT03299816|144390100|SUPERIORITY|||||||0.61||||||The a priori threshold for statistical significance was \<0.05|Mixed effects regression|Urinary albumin-to-creatinine ratio (ACR) was not normally distributed and was natural log transformed for analyses||||||0.61
72558747|NCT02034513|144647477|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was considered confirmed if the 95% confidence interval for the rate ratio (IDeg/IGlar) was ≤1.10 or equivalently if the p-value for the 1-sided test of H0: RR \>1.10 against HA: RR ≤1.10 was less than 2.5%, where RR is the estimated rate ratio IDeg/IGlar.|Treatment ratio|0.89|||<|0.0001|TWO_SIDED|95.0|0.85|0.94|||Poisson||If non-inferiority was confirmed the superiority of IDeg/IGlar was investigated outside of the test hierarchy. Superiority was considered confirmed if the upper bound of the 2-sided 95% confidence interval was \<1.00.|Statistical analysis was performed on the FAS. Number of subjects analysed=subjects in the FAS, who were exposed in at least one maintenance period. Stepwise hierarchical testing procedure was applied for confirmatory endpoints: Step 1: Number of treatment-emergent severe or BG confirmed symptomatic hypoglycaemic episodes during the maintenance period.||0.94|0.85|<0.0001
72558748|NCT02034513|144647478|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was considered confirmed if the 95% confidence interval for the rate ratio (IDeg/IGlar) was ≤1.10 or equivalently if the p-value for the 1-sided test of H0: RR \>1.10 against HA: RR ≤1.10 was less than 2.5%, where RR is the estimated rate ratio IDeg/IGlar.|Treatment ratio|0.64|||<|0.0001|TWO_SIDED|95.0|0.56|0.73|||Poisson||If non-inferiority was confirmed the superiority of IDeg/IGlar was investigated outside of the test hierarchy. Superiority was considered confirmed if the upper bound of the 2-sided 95% confidence interval was \<1.00.|Statistical analysis was performed on the FAS. Number of subjects analysed=subjects in the FAS, who were exposed in at least one maintenance period. Stepwise hierarchical testing procedure was applied for confirmatory endpoints: Step 2: Number of treatment-emergent severe or BG confirmed symptomatic nocturnal hypoglycaemic episodes during the maintenance period.||0.73|0.56|<0.0001
72558749|NCT02034513|144647479|SUPERIORITY_OR_OTHER|||||||0.0016||||||Superiority was confirmed if the p-value was less than 0.025.|McNemar|||Statistical analysis was performed on the FAS. Number of subjects analysed=subjects in the FAS, who were exposed in both the maintenance periods. Stepwise hierarchical testing procedure was applied for confirmatory endpoints: Step 3: Proportion of subjects with one or more severe hypoglycaemic episodes during the maintenance period.||||0.0016
72618865|NCT02504775|144768274|NON_INFERIORITY_OR_EQUIVALENCE|Log-transformed PK parameter was compared between products using a linear mixed effects model including terms for product, period, sequence as fixed effect and subject nested within sequence as random effect. Bioequivalence was concluded, when the 90% confidence interval (CI) for the geometric LS mean ratios were fully contained within the predefined equivalence limits of 0.80 to 1.25|Ratio of Averages of Tylenol/Mejoral|95.989|||||TWO_SIDED|90.0|89.826|102.574|||ANOVA|||||102.574|89.826|
72438401|NCT03299816|144390101|SUPERIORITY|||||||0.73||||||The a priori threshold for statistical significance was \<0.05|Mixed effects regression|Urinary albumin-to-creatinine ratio (ACR) was not normally distributed and was natural log transformed for analyses||||||0.73
72438402|NCT03299816|144390102|SUPERIORITY|||||||0.75||||||The a priori threshold for statistical significance was \<0.05|Mixed effects regression|||||||0.75
72438403|NCT03520413|144390103|EQUIVALENCE|Difference between groups at 12months|Mean Difference (Final Values)|-0.61||||0.02|TWO_SIDED|95.0|-1.12|-0.11|||Mixed Models Analysis|||||-0.11|-1.12|0.02
72438404|NCT03520413|144390104|EQUIVALENCE|Difference between groups at 12months|Mean Difference (Final Values)|-0.25||||0.007|TWO_SIDED|95.0|-0.42|-0.07|||Mixed Models Analysis|||||-0.07|-0.42|0.007
72438405|NCT03520413|144390105|EQUIVALENCE|Difference between groups at 12months|Mean Difference (Final Values)|0.51||||0.0002|TWO_SIDED|95.0|0.25|0.78|||Mixed Models Analysis|||||0.78|0.25|0.0002
72438406|NCT03520413|144390106|EQUIVALENCE|Difference between groups at 12months|Mean Difference (Final Values)|0.39||||0.02|TWO_SIDED|95.0|0.07|0.71|||Mixed Models Analysis|||||0.71|0.07|0.02
72438407|NCT03520413|144390107|EQUIVALENCE|Difference between groups at 6months|Mean Difference (Final Values)|0.19||||0.39|TWO_SIDED|95.0|-0.24|0.62|||Mixed Models Analysis|||||0.62|-0.24|0.39
72438408|NCT03520413|144390108|EQUIVALENCE|Difference between groups at 12months|Mean Difference (Final Values)|-1.16||||0.1|TWO_SIDED|95.0|-2.53|0.21|||Mixed Models Analysis|||||0.21|-2.53|0.10
72438409|NCT02311907|144390109|SUPERIORITY_OR_OTHER|||||||0.21|TWO_SIDED||||||ANOVA|||Generalized linear models (repeated measures analysis of variance \[ANOVA\]) will be used to compare the CIPN between GSH and placebo arms.||||0.21
72438410|NCT02311907|144390110|SUPERIORITY_OR_OTHER|||||||0.63|||||||Log Rank|||||||0.63
72438411|NCT00891930|144390200|SUPERIORITY|||||||0.013|||||||Regression, Cox|||||||0.0130
72438412|NCT04283552|144390254|SUPERIORITY|||||||0.001|||||||Two-tailed Wildoxon signed-rank test|||This statistical analysis is for Reader 1.||||0.001
72438413|NCT04283552|144390254|SUPERIORITY|||||||0.28|||||||Two-tailed Wilcoxon signed-rank test|||This statistical analysis is for Reader 2.||||0.28
72438414|NCT04283552|144390255|SUPERIORITY|||||||0.22|||||||Two-tailed Wilcoxon signed-rank test.|||This is the statistical analysis for Reader 1.||||0.22
72438415|NCT04283552|144390255|SUPERIORITY||||||>|0.05|||||||Two-tailed Wilcoxon signed-rank test.|||This is the statistical analysis for Reader 2.||||>0.05
72438416|NCT04283552|144390256|SUPERIORITY|||||||0.009|||||||Two-tailed Wilcoxon signed-rank test.|||This is the statistical analysis for Reader 1.||||0.009
72438417|NCT04283552|144390256|SUPERIORITY||||||>|0.05|||||||Two-tailed Wilcoxon signed-rank test.|||This statistical analysis is for Reader 2.||||>0.05
72438418|NCT04283552|144390257|SUPERIORITY||||||<|0.001|||||||Two-tailed Wilcoxon signed-rank test.|||This is the statistical analysis for Reader 1.||||<0.001
72438419|NCT04283552|144390257|SUPERIORITY|||||||0.02|||||||Two-tailed Wilcoxon signed-rank test.|||This is the statistical analysis for Reader 2.||||0.02
72438420|NCT04283552|144390258|SUPERIORITY||||||<|0.001|||||||Two-tailed Wilcoxon signed-rank test.|||This is the statistical analysis for Reader 1.||||<0.001
72438421|NCT04283552|144390258|SUPERIORITY|||||||0.02|||||||Two-tailed Wilcoxon signed-rank test.|||This is the statistical analysis for Reader 2.||||0.02
72438422|NCT04283552|144390261|SUPERIORITY||||||<|0.001|||||||Two-tailed Wilcoxon signed-rank test.|||This is the statistical analysis comparing PS-Early Reader 1 to PS-Late Reader 1.||||<0.001
72438423|NCT04283552|144390261|SUPERIORITY||||||<|0.001|||||||Two-tailed Wilcoxon signed-rank test.|||This is the statistical analysis comparing PS-Early Reader 2 and PS-Late Reader 2.||||<0.001
72438424|NCT01240330|144390275|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|18.9|STANDARD_DEVIATION|7.46|<|0.0001|TWO_SIDED|95.0|16.3|21.59|||t-test, 1 sided|||The femoral venous peak flow velocity (PFV) compared to the subject's own resting baseline PFV.||21.59|16.30|<0.0001
72438425|NCT03260140|144390282|SUPERIORITY||Mean Difference (Final Values)|-1.93||||0.001|TWO_SIDED|97.5|-3.24|-0.61|||Mixed Models Analysis|Difference in average weight at 12 months between control and intervention groups.|Standard errors estimated using Kenward-Rogers adjustment for the denominator degrees of freedom.|Linear mixed model analysis comparing the average 12-month weight between control and intervention groups. Our analysis controlled for randomization strata: age (less than or greater than/equal to 65), BMI (at least 30/less than 35, at least 35/less than 40, or at least 40/less than for 45), and population density (rural or urban), while random effects were used to account for within-person variability.||-0.61|-3.24|0.001
72438426|NCT03260140|144390283|SUPERIORITY||Mean Difference (Final Values)|0.69||||0.388|TWO_SIDED|97.5|-1.11|2.49|||Mixed Models Analysis|Difference in average SF-12 PCS score at 12 months between control and intervention groups.|Standard errors estimated using Kenward-Rogers adjustment for the denominator degrees of freedom.|Linear mixed model analysis comparing the 12-month SF-12 PCS between control and intervention groups. Our analysis controlled for randomization strata: age (less than or greater than/equal to 65), BMI (at least 30/less than 35, at least 35/less than 40, or at least 40/less than for 45), and population density (rural or urban), while random effects were used to account for within-person variability.||2.49|-1.11|0.388
72438427|NCT03260140|144390284|SUPERIORITY||Sign test|1.76||||0.308|TWO_SIDED|95.0|0.85|3.66|||F test-ratio of 2 McNemar's Chi-Squares|||Group-specific McNemar's Chi-Square tests were applied to examine the change from baseline to follow-up in dichotomized IPAQ (\>=150 vs \<150) minutes of physical activity per week. To compare intervention vs. control at 12 months, we applied an F test. The intervention effect was an odds ratio of the ratios of discordant pairs in the intervention vs the control group.||3.66|0.85|0.308
72438428|NCT03260140|144390285|SUPERIORITY||Mean Difference (Final Values)|-0.18||||0.396|TWO_SIDED|95.0|-0.61|0.24|||Mixed Models Analysis|Difference in average weight at 12 months between control and intervention groups.|Standard errors estimated using Kenward-Rogers adjustment for the denominator degrees of freedom.|Linear mixed model analysis comparing the average 12-month score between control and intervention groups. Our analysis controlled for randomization strata: age (less than or greater than/equal to 65), BMI (at least 30/less than 35, at least 35/less than 40, or at least 40/less than for 45), and population density (rural or urban), while random effects were used to account for within-person variability.||0.24|-0.61|0.396
72438429|NCT03260140|144390286|SUPERIORITY||Mean Difference (Final Values)|0.3||||0.657|TWO_SIDED|95.0|-1.02|1.61|||Mixed Models Analysis|Difference in average score at 12 months between control and intervention groups.|Standard errors estimated using Kenward-Rogers adjustment for the denominator degrees of freedom.|Linear mixed model analysis comparing the average 12-month score between control and intervention groups. Our analysis controlled for randomization strata: age (less than or greater than/equal to 65), BMI (at least 30/less than 35, at least 35/less than 40, or at least 40/less than for 45), and population density (rural or urban), while random effects were used to account for within-person variability.||1.61|-1.02|0.657
72438430|NCT03260140|144390287|SUPERIORITY||Mean Difference (Final Values)|-0.83||||0.281|TWO_SIDED|95.0|-2.33|0.68|||Mixed Models Analysis|Difference in average score at 12 months between control and intervention groups.|Standard errors estimated using Kenward-Rogers adjustment for the denominator degrees of freedom.|Linear mixed model analysis comparing the average 12-month score between control and intervention groups. Our analysis controlled for randomization strata: age (less than or greater than/equal to 65), BMI (at least 30/less than 35, at least 35/less than 40, or at least 40/less than for 45), and population density (rural or urban), while random effects were used to account for within-person variability.||0.68|-2.33|0.281
72438431|NCT03260140|144390288|SUPERIORITY||Mean Difference (Final Values)|0.06||||0.483|TWO_SIDED|95.0|-0.11|0.23|||Mixed Models Analysis|Difference in average score at 12 months between control and intervention groups.|Standard errors estimated using Kenward-Rodgers adjustment for the denominator degrees of freedom.|Linear mixed model analysis comparing the average score between control and intervention groups. Our analysis controlled for randomization strata: age (less than or greater than/equal to 65), BMI (at least 30/less than 35, at least 35/less than 40, or at least 40/less than for 45), and population density (rural or urban), while random effects were used to account for within-person variability.||0.23|-0.11|0.483
72495296|NCT00915343|144519609|SUPERIORITY_OR_OTHER_LEGACY||Mean difference|110.417||||0.0357|TWO_SIDED|95.0|16.755|204.078|||Fisher's non-parametric permutation test|||||204.078|16.755|0.0357
72495297|NCT00915343|144519610|SUPERIORITY_OR_OTHER_LEGACY||Mean difference|-38.076|||<|0.0001|TWO_SIDED|95.0|-50.276|25.876|||Fisher's non-parametric permutation test|||||25.876|-50.276|<0.0001
72495298|NCT00915343|144519611|SUPERIORITY_OR_OTHER_LEGACY||Mean difference|-65.782||||0.0033|TWO_SIDED|95.0|-109.201|22.362|||Fisher's non-parametric permutation test|||||22.362|-109.201|0.0033
72385880|NCT03693300|144279217|OTHER||Proportion (%)|4.4|||||TWO_SIDED|95.0|1.44|9.94|||||95% CI were based on the Clopper-Pearson method.|Any possibly related AEs of Grade 3 or Grade 4 with onset date within 6 months of the first dose||9.94|1.44|
72385881|NCT03693300|144279217|OTHER||Proportion (%)|0.0|||||TWO_SIDED|95.0|0.0|70.76|||||95% CI were based on the Clopper-Pearson method.|Any possibly related AEs of Grade 3 or Grade 4 with onset date within 6 months of the first dose||70.76|0.00|
72385882|NCT03693300|144279217|OTHER||Proportion (%)|4.3|||||TWO_SIDED|95.0|1.4|9.69|||||95% CI were based on the Clopper-Pearson method.|Any possibly related AEs of Grade 3 or Grade 4 with onset date within 6 months of the first dose||9.69|1.40|
72385883|NCT00866788|144279240|SUPERIORITY_OR_OTHER|||||||0.1601||||||The p-value was based on the van Elteren test (stratified by baseline weight ≥ 80 or \< 80 kg).|van Elteren test|||||||0.1601
72385884|NCT00866788|144279240|SUPERIORITY_OR_OTHER|||||||0.0003||||||The p-value was based on the van Elteren test (stratified by baseline weight ≥ 80 or \< 80 kg).|van Elteren test|||||||0.0003
72385885|NCT00866788|144279240|SUPERIORITY_OR_OTHER|||||||0.0473||||||The p-value was based on the van Elteren test (stratified by baseline weight ≥ 80 or \< 80 kg).|van Elteren test|||||||0.0473
72385886|NCT00866788|144279241|SUPERIORITY_OR_OTHER|||||||0.164||||||The p-value was based on the van Elteren test (stratified by baseline weight ≥ 80 or \< 80 kg).|van Elteren test|||||||0.1640
72385887|NCT00866788|144279241|SUPERIORITY_OR_OTHER|||||||0.0005||||||The p-value was based on the van Elteren test (stratified by baseline weight ≥ 80 or \< 80 kg).|van Elteren test|||||||0.0005
72385888|NCT00866788|144279241|SUPERIORITY_OR_OTHER|||||||0.0558||||||The p-value was based on the van Elteren test (stratified by baseline weight ≥ 80 or \< 80 kg).|van Elteren test|||||||0.0558
72385889|NCT00866788|144279242|SUPERIORITY_OR_OTHER|||||||0.1411||||||The p-value was based on the van Elteren test (stratified by baseline weight ≥ 80 or \< 80 kg).|van Elteren test|||||||0.1411
72385890|NCT00866788|144279242|SUPERIORITY_OR_OTHER|||||||0.0003||||||The p-value was based on the van Elteren test (stratified by baseline weight ≥ 80 or \< 80 kg).|van Elteren test|||||||0.0003
72495299|NCT00915343|144519612|SUPERIORITY_OR_OTHER_LEGACY||Mean difference|-148.015|||<|0.0001|TWO_SIDED|95.0|-189.469|-106.561|||Fisher's non-parametric permutation test|||||-106.561|-189.469|<0.0001
72385891|NCT00866788|144279242|SUPERIORITY_OR_OTHER|||||||0.0248||||||The p-value was based on the van Elteren test (stratified by baseline weight ≥ 80 or \< 80 kg).|van Elteren test|||||||0.0248
72385892|NCT00866788|144279243|SUPERIORITY_OR_OTHER|||||||0.5507||||||The p-value was based on the van Elteren test (stratified by baseline weight ≥ 80 or \< 80 kg).|van Elteren test|||||||0.5507
72385893|NCT00866788|144279243|SUPERIORITY_OR_OTHER|||||||0.1525||||||The p-value was based on the van Elteren test (stratified by baseline weight ≥ 80 or \< 80 kg).|van Elteren test|||||||0.1525
72385894|NCT00866788|144279243|SUPERIORITY_OR_OTHER|||||||0.0449||||||The p-value was based on the van Elteren test (stratified by baseline weight ≥ 80 or \< 80 kg).|van Elteren test|||||||0.0449
72385895|NCT00866788|144279244|SUPERIORITY_OR_OTHER|||||||0.7261||||||The p-value was based on the van Elteren test (stratified by baseline weight ≥ 80 or \< 80 kg).|van Elteren test|||||||0.7261
72385896|NCT00866788|144279244|SUPERIORITY_OR_OTHER|||||||0.162||||||The p-value was based on the van Elteren test (stratified by baseline weight ≥ 80 or \< 80 kg).|van Elteren test|||||||0.162
72385897|NCT00866788|144279244|SUPERIORITY_OR_OTHER|||||||0.6504||||||The p-value was based on the van Elteren test (stratified by baseline weight ≥ 80 or \< 80 kg).|van Elteren test|||||||0.6504
72385898|NCT02742441|144279254|SUPERIORITY||||||<|0.001||||||"Treatment groups were compared with respect to the proportions of subjects with treatment success at Day 15 using the Cochran-Mantel-Haenszel (CMH) test stratified by analysis center."|Cochran-Mantel-Haenszel|Missing data was imputed as treatment failure.||||||<0.001
72385899|NCT02742441|144279255|SUPERIORITY||||||<|0.001||||||Statistical significance was achieved for each of the clinical signs of psoriasis.|Cochran-Mantel-Haenszel|Missing data was imputed as treatment failure.||Treatment groups were compared with respect to each of the clinical signs of psoriasis (plaque elevation, scaling, and erythema).||||<0.001
72385900|NCT02742441|144279256|SUPERIORITY|||||||0.012|||||||Cochran-Mantel-Haenszel|||||||0.012
72385901|NCT01788046|144279308|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|30.8|||<|0.001|TWO_SIDED|95.0|18.18|52.17|||Cochran-Mantel-Haenszel|||A Cochran-Mantel-Haenszel test stratified by screening PTH category (\< 600, ≥ 600 to ≤ 1000, and \> 1000 pg/mL), recent cinacalcet use within 8 weeks before randomization (yes and no), and region (North America and non-North America) was used to compare the primary endpoint of percentage of participants with \> 30% reduction from baseline in PTH during the EAP between etelcalcetide and placebo.||52.17|18.18|< 0.001
72385902|NCT01788046|144279309|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|33.92|||<|0.001|TWO_SIDED|95.0|16.35|70.37|||Cochran-Mantel-Haenszel|Stratified by screening PTH category, prior cinacalcet use within 8 weeks prior to randomization, and region.||||70.37|16.35|< 0.001
72385903|NCT01788046|144279310|SUPERIORITY_OR_OTHER||Mean Difference|-71.34|STANDARD_ERROR_OF_MEAN|3.15|<|0.001|TWO_SIDED|95.0|-77.53|-65.14|||Repeated Measures Mixed Effects Model|Repeated measures mixed-effects model included treatment, stratification factors, visit, and treatment by visit interaction as covariates.|Etelcalcetide - Placebo|||-65.14|-77.53|< 0.001
72385904|NCT01788046|144279311|SUPERIORITY_OR_OTHER||Mean Difference|-7.2|STANDARD_ERROR_OF_MEAN|0.6|<|0.001|TWO_SIDED|95.0|-8.38|-6.03|||Repeated Measures Mixed Effects Model|Repeated measures mixed-effects model included treatment, stratification factors, visit, and treatment by visit interaction as covariates.|Etelcalcetide - Placebo|||-6.03|-8.38|< 0.001
72385905|NCT01788046|144279312|SUPERIORITY_OR_OTHER||Mean Difference|-14.58|STANDARD_ERROR_OF_MEAN|2.07|<|0.001|TWO_SIDED|95.0|-18.65|-10.51|||Repeated Measures Mixed Effects Model|Repeated measures mixed-effects model included treatment, stratification factors, visit, and treatment by visit interaction as covariates.|Etelcalcetide - Placebo|||-10.51|-18.65|< 0.001
72385906|NCT01788046|144279313|SUPERIORITY_OR_OTHER||Mean Difference|-8.04|STANDARD_ERROR_OF_MEAN|2.09|<|0.001|TWO_SIDED|95.0|-12.15|-3.92|||Repeated Measures Mixed Effects Model|Repeated measures mixed-effects model included treatment, stratification factors, visit, and treatment by visit interaction as covariates.|Etelcalcetide - Placebo|||-3.92|-12.15|< 0.001
72495300|NCT00915343|144519613|SUPERIORITY_OR_OTHER_LEGACY||Mean difference|-108.306|||<|0.0001|TWO_SIDED|95.0|-140.193|-76.42|||Fisher's non-parametric permutation test|||||-76.420|-140.193|<0.0001
72385907|NCT00850070|144279316|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.0|||<|0.35|||||||Chi-squared||Estimated value comparison was active treatment minus placebo.|Chi-square analyses were used to assess CGI-I scores. There were no transformations.||||<.35
72438432|NCT03260140|144390289|SUPERIORITY||Mean percent change in HbA1c|0.02||||0.985|TWO_SIDED|95.0|-2.57|2.69|||Mixed Models Analysis|Difference in average HbA1c at 12 months between control and intervention groups.|Standard errors estimated using Kenward-Rogers adjustment for the denominator degrees of freedom.|Linear mixed model analysis on log-transformed HbA1c comparing the average HbA1c between control and intervention groups. Our analysis controlled for randomization strata: age (less than or greater than/equal to 65), BMI (at least 30/less than 35, at least 35/less than 40, or at least 40/less than for 45), and population density (rural or urban), while random effects were used to account for within-person variability.||2.69|-2.57|0.985
72438433|NCT03260140|144390290|SUPERIORITY||Mean Difference (Net)|-0.22||||0.806|TWO_SIDED|95.0|-1.99|1.55|||Mixed Models Analysis|Difference in average SF-12 MCS score at 12 months between control and intervention groups.|Standard errors estimated using Kenward-Rogers adjustment for the denominator degrees of freedom.|Linear mixed model analysis comparing the average 12-month MCS between control and intervention groups. Our analysis controlled for randomization strata: age (less than or greater than/equal to 65), BMI (at least 30/less than 35, at least 35/less than 40, or at least 40/less than for 45), and population density (rural or urban), while random effects were used to account for within-person variability.||1.55|-1.99|0.806
72438434|NCT03260140|144390291|SUPERIORITY||Mean Difference (Final Values)|-0.36||||0.62|TWO_SIDED|95.0|-1.77|1.05|||Mixed Models Analysis|Difference in average DBP at 12 months between control and intervention groups.|Standard errors estimated using Kenward-Rogers adjustment for the denominator degrees of freedom.|Linear mixed model analysis comparing the average 12-month DBP between control and intervention groups. Our analysis controlled for randomization strata: age (less than or greater than/equal to 65), BMI (at least 30/less than 35, at least 35/less than 40, or at least 40/less than for 45), and population density (rural or urban), while random effects were used to account for within-person variability.||1.05|-1.77|0.620
72438435|NCT03260140|144390292|SUPERIORITY||Mean Difference (Final Values)|-0.02||||0.987|TWO_SIDED|95.0|-2.32|2.28|||Mixed Models Analysis|Difference in average SPB at 12 months between control and intervention groups.|Standard errors estimated using Kenward-Rogers adjustment for the denominator degrees of freedom.|Linear mixed model analysis comparing the average SBP between control and intervention groups. Our analysis controlled for randomization strata: age (less than or greater than/equal to 65), BMI (at least 30/less than 35, at least 35/less than 40, or at least 40/less than for 45), and population density (rural or urban), while random effects were used to account for within-person variability.||2.28|-2.32|0.987
72438436|NCT03505099|144390344|SUPERIORITY||Difference of Proportion|76.5|||<|0.0001|TWO_SIDED|95.0|50.95|92.21|||Fisher Exact||||Data for the current study were compared to historical control data (Finkel et al, 2014 - PubMed 25080519) where 19 out of 81 participants (23.46%) with 3 copies of SMN2 achieved standing alone for at least 3 seconds.|92.21|50.95|<0.0001
72385908|NCT00850070|144279317|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.0|||<|0.06|||||||Chi-squared|||||||<0.06
72385909|NCT00850070|144279323|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.0|STANDARD_ERROR_OF_MEAN|0.9||0.05|||||||Mixed Models Analysis|||||||0.05
72385910|NCT00074984|144279326|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.574||||0.1449|TWO_SIDED|95.0|0.269|1.222|||Log Rank|Comparison is based on a 2-sided log-rank test.||||1.222|0.269|0.1449
72385911|NCT00074984|144279326|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.465||||0.0577|TWO_SIDED|95.0|0.211|1.025|||Wald Test|||Time to First Primary Endpoint Adjusting for Baseline Proteinuria using Cox Proportional Hazards Model||1.025|0.211|0.0577
72385912|NCT00074984|144279327|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.732||||0.5261|TWO_SIDED|95.0|0.278|1.927|||Log Rank|2-sided log-rank test||Analysis of Time to First Renal Event for ITT population.||1.927|0.278|0.5261
72385913|NCT00395733|144279393|NON_INFERIORITY_OR_EQUIVALENCE|Estimates for investigators only. A non-inferiority margin of 15% was assumed. Based on 60 pairs of observations in a crossover design (15 participants with 10 vessels segments, 15 participants with 6 vessels segments and 30 participants with 17 vessels segments to be visualized and assessed) and non-inferiority testing based the lower limit of Fieller's one-sided 95% confidence interval for the ratio Gadavist / Magnevist of the means, the power was at least 80% under realistic assumptions.|Ratio of means|0.9736||||||90.0|0.9315|1.0168|||Fieller-type confidence interval||For the estimation, only vessel segments with vascular assessments available for both periods were considered. The lower limit of the 95% one-sided Fieller-type confidence interval was compared with the non-inferiority margin 0.85.|Non-inferiority analysis: The aim was to show that Gadavist is not inferior (i.e. similar or better) to Magnevist in visualizing different vascular regions of the body with diagnostic quality in contrast enhanced MRA. Gadavist was to be considered to be non-inferior to Magnevist if the mean number of vessel segments visualized with diagnostic quality of Gadavist enhanced-MRA images was higher than 85% of that of Magnevist enhanced-MRA images in a cross-over design.||1.0168|0.9315|
72385914|NCT00395733|144279393|NON_INFERIORITY_OR_EQUIVALENCE|Estimates for blinded reader 1 only. A non-inferiority margin of 15% was assumed. Based on 60 pairs of observations in a crossover design (15 participants with 10 vessels segments, 15 participants with 6 vessels segments and 30 participants with 17 vessels segments to be visualized and assessed) and non-inferiority testing based the lower limit of Fieller's one-sided 95% confidence interval for the ratio Gadavist / Magnevist of the means, the power was at least 80% under realistic assumptions.|Ratio of means|0.954||||||90.0|0.9122|0.9965|||Fieller-type confidence interval||For the estimation, only vessel segments with vascular assessments available for both periods were considered. The lower limit of the 95% one-sided Fieller-type confidence interval was compared with the non-inferiority margin 0.85.|Non-inferiority analysis: The aim was to show that Gadavist is not inferior (i.e. similar or better) to Magnevist in visualizing different vascular regions of the body with diagnostic quality in contrast enhanced MRA. Gadavist was to be considered to be non-inferior to Magnevist if the mean number of vessel segments visualized with diagnostic quality of Gadavist enhanced-MRA images was higher than 85% of that of Magnevist enhanced-MRA images in a cross-over design.||0.9965|0.9122|
72438437|NCT03505099|144390345|SUPERIORITY||Difference of Proportion|73.9|||<|0.0001|TWO_SIDED|95.0|44.67|91.61|||Fisher Exact||||Data for the current study were compared to historical control data (Finkel et al 2014 - PubMed 25080519) where 6 out of 23 participants (26.09%) with 2 copies of SMN2 were alive and did not require permanent ventilation.|91.61|44.67|<0.0001
72385915|NCT00395733|144279393|NON_INFERIORITY_OR_EQUIVALENCE|Estimates for blinded reader 2 only. A non-inferiority margin of 15% was assumed. Based on 60 pairs of observations in a crossover design (15 participants with 10 vessels segments, 15 participants with 6 vessels segments and 30 participants with 17 vessels segments to be visualized and assessed) and non-inferiority testing based the lower limit of Fieller's one-sided 95% confidence interval for the ratio Gadavist / Magnevist of the means, the power was at least 80% under realistic assumptions.|Ratio of means|0.9458||||||90.0|0.8776|1.024|||Fieller-type confidence interval||For the estimation, only vessel segments with vascular assessments available for both periods were considered. The lower limit of the 95% one-sided Fieller-type confidence interval was compared with the non-inferiority margin 0.85.|Non-inferiority analysis: The aim was to show that Gadavist is not inferior (i.e. similar or better) to Magnevist in visualizing different vascular regions of the body with diagnostic quality in contrast enhanced MRA. Gadavist was to be considered to be non-inferior to Magnevist if the mean number of vessel segments visualized with diagnostic quality of Gadavist enhanced-MRA images was higher than 85% of that of Magnevist enhanced-MRA images in a cross-over design.||1.0240|0.8776|
72438438|NCT03505099|144390347|SUPERIORITY||Difference of Proportion|72.3|||<|0.0001|TWO_SIDED|95.0|44.9|90.11|||Fisher Exact||||Data for the current study were compared to historical control data (Finkel et al, 2014 - PubMed 25080519) where 17 out of 81 participants (20.99%) with 3 copies of SMN2 achieved the ability to walk alone.|90.11|44.90|<0.0001
72385916|NCT00395733|144279393|NON_INFERIORITY_OR_EQUIVALENCE|Estimates for blinded reader 3 only. A non-inferiority margin of 15% was assumed. Based on 60 pairs of observations in a crossover design (15 participants with 10 vessels segments, 15 participants with 6 vessels segments and 30 participants with 17 vessels segments to be visualized and assessed) and non-inferiority testing based the lower limit of Fieller's one-sided 95% confidence interval for the ratio Gadavist / Magnevist of the means, the power was at least 80% under realistic assumptions.|Ratio of means|0.8698||||||90.0|0.78|0.9657|||Fieller-type confidence interval||For the estimation, only vessel segments with vascular assessments available for both periods were considered. The lower limit of the 95% one-sided Fieller-type confidence interval was compared with the non-inferiority margin 0.85.|Non-inferiority analysis: The aim was to show that Gadavist is not inferior (i.e. similar or better) to Magnevist in visualizing different vascular regions of the body with diagnostic quality in contrast enhanced MRA. Gadavist was to be considered to be non-inferior to Magnevist if the mean number of vessel segments visualized with diagnostic quality of Gadavist enhanced-MRA images was higher than 85% of that of Magnevist enhanced-MRA images in a cross-over design.||0.9657|0.7800|
72395143|NCT02730455|144296813|SUPERIORITY||Adjusted Mean Difference|-0.6||||0.622|TWO_SIDED|95.0|-2.89|1.73|||Mixed-effects model for repeated measure|||Treatment and treatment by visit interaction were included in the model as explanatory variables. Baseline NIHSS category (score 5-15, 16-23), tPA use (yes/no), age (\<60, 60-69, 70-80), thrombectomy (yes/no), region (Spain, UK/Germany, USA) and treatment window were considered as covariates. An unstructured variance-covariance matrix was used in the model.||1.73|-2.89|0.622
72438439|NCT00688519|144390361|SUPERIORITY_OR_OTHER|||||||0.058|||||||Cochran-Mantel-Haenszel|Stratified by pooled center||||||0.058
72438440|NCT00688519|144390361|SUPERIORITY_OR_OTHER|||||||0.313|||||||Breslow-Day Test|Breslow-Day test of the homogeneity of the odds ratio using a 0.1 significance level.||Consistency of results across investigative centers was verified using the Breslow-Day test of homogeneity the odds ration using a significance level of 0.1||||0.313
72438441|NCT00688519|144390362|SUPERIORITY_OR_OTHER|||||||0.029|||||||Cochran-Mantel-Haenszel|||These P-values are provided for information purposes only; they are considered non-significant (per the statistical analysis plan) because the analysis of the primary end point did not reach statistical significance.||||0.029
72438442|NCT00688519|144390363|SUPERIORITY_OR_OTHER|||||||0.013|||||||Cochran-Mantel-Haenszel|Stratified by pooled center||These P-values are provided for information purposes only; they are considered non-significant (per the statistical analysis plan) because the analysis of the primary end point did not reach statistical significance.||||0.013
72438443|NCT00688519|144390364|SUPERIORITY_OR_OTHER|||||||0.008|||||||Cochran-Mantel-Haenszel|Stratified by pooled center||These P-values are provided for information purposes only; they are considered non-significant (per the statistical analysis plan) because the analysis of the primary end point did not reach statistical significance.||||0.008
72438444|NCT00688519|144390365|SUPERIORITY_OR_OTHER|||||||0.018|||||||Cochran-Mantel-Haenszel|Stratified by pooled center||These P-values are provided for information purposes only; they are considered non-significant (per the statistical analysis plan) because the analysis of the primary end point did not reach statistical significance.||||0.018
72438445|NCT00688519|144390366|SUPERIORITY_OR_OTHER|||||||0.167|||||||Cochran-Mantel-Haenszel|stratified by pooled center||Comparison of calcipotriene foam and vehicle foam for patients who had mild disease at baseline||||0.167
72438446|NCT00688519|144390366|SUPERIORITY_OR_OTHER|||||||0.009|||||||Cochran-Mantel-Haenszel|stratified by pooled center||Comparison of calcipotriene foam and vehicle foam for patients who had moderate disease at baseline||||0.009
72438447|NCT04036058|144390374|SUPERIORITY|||||||0.611|||||||t-test, 2 sided|||||||0.611
72438448|NCT04036058|144390375|SUPERIORITY|||||||0.0435|||||||t-test, 2 sided|||||||0.0435
72438449|NCT04036058|144390376|SUPERIORITY|||||||0.1158|||||||t-test, 2 sided|||||||0.1158
72438450|NCT04036058|144390377|SUPERIORITY|||||||0.0898|||||||t-test, 2 sided|||||||0.0898
72438451|NCT04036058|144390378|SUPERIORITY|||||||0.114|||||||t-test, 2 sided|||||||0.114
72438452|NCT03351075|144390385|SUPERIORITY||Mean Difference (Net)|-1.31||||0.5163|TWO_SIDED|95.0|-5.28|2.65||No corrections for multiple testing were performed.|Multivariate linear model|A multivariate linear model for longitudinal measures with an unstructured covariance matrix was applied for each continuous outcome.||The sample size was based on comparing the changes for the primary outcome measure (PDI-DLV) at 12 months after surgery. The calculation was based on comparing the values at 12 months. Assuming a coefficient of variation (CV) equal to 0.5, 87 participants per group were needed based on a two-sample pooled t-test of a mean ratio with lognormal data and α=0.05 to detect with 80% power a difference of 20% in PDI. To anticipate a drop-out ratio of 5%, a total of 184 subjects were needed.||2.65|-5.28|0.5163
72438453|NCT03351075|144390386|SUPERIORITY||Mean Difference (Net)|-0.97||||0.5655|TWO_SIDED|95.0|-4.26|2.33||No corrections for multiple testing were performed.|multivariate linear model|A multivariate linear model for longitudinal measures with an unstructured covariance matrix was applied for each continuous outcome.||Difference in change in self-reported pain-related disability from baseline to 4 months||2.33|-4.26|0.5655
72495301|NCT00915343|144519614|SUPERIORITY_OR_OTHER_LEGACY||Mean difference|0.27||||0.0214|TWO_SIDED|95.0|0.028|0.512|||Fisher's non-parametric permutation test|||||0.512|0.028|0.0214
72438454|NCT03351075|144390386|SUPERIORITY||Mean Difference (Net)|-1.07||||0.5592|TWO_SIDED|95.0|-4.64|2.51||P\<.05 was considered significant. No corrections for multiple testing were performed.|multivariate linear model|A multivariate linear model for longitudinal measures with an unstructured covariance matrix was applied for each continuous outcome.||Difference in change in self-reported pain-related disability from baseline to 1.5 years||2.51|-4.64|0.5592
72438455|NCT03351075|144390387|SUPERIORITY||Mean Difference (Net)|-2.23||||0.563|TWO_SIDED|95.0|-9.84|5.37||No corrections for multiple testing were performed.|Multivariate linear model|A multivariate linear model for longitudinal measures with an unstructured covariance matrix was applied for each continuous outcome.||Difference in change in self-reported pain intensity from baseline to 4 months||5.37|-9.84|0.5630
72438456|NCT03351075|144390387|SUPERIORITY||Mean Difference (Net)|-4.3||||0.2524|TWO_SIDED|95.0|-11.68|3.09||No corrections for multiple testing were performed.|Multivariate linear model|A multivariate linear model for longitudinal measures with an unstructured covariance matrix was applied for each continuous outcome.||Difference in change in self-reported pain intensity from baseline to 12 months||3.09|-11.68|0.2524
72438457|NCT03351075|144390387|SUPERIORITY||Mean Difference (Net)|-4.8||||0.2315|TWO_SIDED|95.0|-12.69|3.09|||Multivariate linear model|A multivariate linear model for longitudinal measures with an unstructured covariance matrix was applied for each continuous outcome.||Difference in change in self-reported pain intensity from baseline to 1.5 years||3.09|-12.69|0.2315
72438458|NCT03351075|144390388|SUPERIORITY||Mean Difference (Net)|0.47||||0.7494|TWO_SIDED|95.0|-2.39|3.32||No corrections for multiple testing were performed.|Multivariate linear model|A multivariate linear model for longitudinal measures with an unstructured covariance matrix was applied for each continuous outcome.||Difference in change in self-reported central sensitisation symptoms from baseline to 4 months.||3.32|-2.39|0.7494
72438459|NCT03351075|144390388|SUPERIORITY||Mean Difference (Net)|-0.25||||0.8617|TWO_SIDED|95.0|-3.09|2.58|||Multivariate linear model|A multivariate linear model for longitudinal measures with an unstructured covariance matrix was applied for each continuous outcome.||The difference in change in self-reported central sensitisation symptoms from baseline to 12 months.||2.58|-3.09|0.8617
72438460|NCT03351075|144390388|SUPERIORITY||Mean Difference (Net)|-0.29||||0.8454|TWO_SIDED|95.0|-3.16|2.59|||Multivariate linear model|A multivariate linear model for longitudinal measures with an unstructured covariance matrix was applied for each continuous outcome.||Difference in change in self-reported central sensitisation symptoms from baseline to 1.5 years||2.59|-3.16|0.8454
72438461|NCT03351075|144390389|SUPERIORITY||Mean Difference (Net)|1.35||||0.3463|TWO_SIDED|95.0|0.72|2.51|||multivariate linear model|A multivariate linear model for longitudinal measures with an unstructured covariance matrix was applied for each continuous outcome.||Difference in change in mechanical detection sensitivity at the arm from baseline to 4 months||2.51|0.72|0.3463
72438462|NCT03351075|144390389|SUPERIORITY||Mean Difference (Net)|0.86||||0.6613|TWO_SIDED|95.0|0.451|1.66|||Multivariate linear model|A multivariate linear model for longitudinal measures with an unstructured covariance matrix was applied for each continuous outcome.||Difference in change in mechanical detection sensitivity at the arm from baseline to 1 year||1.66|0.451|0.6613
72438463|NCT03351075|144390389|SUPERIORITY||Mean Difference (Net)|1.26||||0.4908|TWO_SIDED|95.0|0.65|2.42|||Multivariate linear model|A multivariate linear model for longitudinal measures with an unstructured covariance matrix was applied for each continuous outcome.||Difference in change in mechanical detection sensitivity at the arm from baseline to 1.5 years||2.42|0.65|0.4908
72438464|NCT03351075|144390390|SUPERIORITY||Mean Difference (Net)|0.22||||0.7708|TWO_SIDED|95.0|-1.25|1.69|||Multivariate linear model|A multivariate linear model for longitudinal measures with an unstructured covariance matrix was applied for each continuous outcome.||Difference in change in warmth detection sensitivity from baseline to 4 months||1.69|-1.25|0.7708
72438465|NCT03351075|144390390|SUPERIORITY||Mean Difference (Net)|0.29||||0.706|TWO_SIDED|95.0|-1.23|1.81|||Multivariate linear model|A multivariate linear model for longitudinal measures with an unstructured covariance matrix was applied for each continuous outcome.||Difference in change in warmth detection sensitivity from baseline to 1 year||1.81|-1.23|0.7060
72438466|NCT03351075|144390390|SUPERIORITY||Mean Difference (Net)|0.02||||0.9806|TWO_SIDED|95.0|-1.38|1.42|||Multivariate linear model|||Difference in change in warmth detection sensitivity from baseline to 1.5 years||1.42|-1.38|0.9806
72438467|NCT03351075|144390391|SUPERIORITY||Mean Difference (Net)|0.74||||0.0284|TWO_SIDED|95.0|0.08|1.4|||Multivariate linear model|A multivariate linear model for longitudinal measures with an unstructured covariance matrix was applied for each continuous outcome||Difference in change in wind-up from baseline to 4 months||1.40|0.08|0.0284
72495302|NCT00915343|144519615|SUPERIORITY_OR_OTHER_LEGACY||Mean difference|-1.042||||0.0714|TWO_SIDED|95.0|-2.098|0.015|||Fisher's non-parametric permutation test|||||0.015|-2.098|0.0714
72438468|NCT03351075|144390391|SUPERIORITY||Mean Difference (Net)|0.09||||0.7776|TWO_SIDED|95.0|-0.55|0.73|||Multivariate linear model|A multivariate linear model for longitudinal measures with an unstructured covariance matrix was applied for each continuous outcome||Difference in change in wind-up from baseline to 1 year||0.73|-0.55|0.7776
72438469|NCT03351075|144390391|SUPERIORITY||Mean Difference (Net)|0.31||||0.3829|TWO_SIDED|95.0|-0.39|1.01|||Multivariate linear model|A multivariate linear model for longitudinal measures with an unstructured covariance matrix was applied for each continuous outcome||Difference in change in wind-up from baseline to 1.5 years||1.01|-0.39|0.3829
72438470|NCT03351075|144390392|SUPERIORITY||Mean Difference (Net)|0.31||||0.1948|TWO_SIDED|95.0|-0.16|0.77|||Multivariate linear model|A multivariate linear model for longitudinal measures with an unstructured covariance matrix was applied for each continuous outcome.||Difference in change in conditioned pain modulation from baseline to 4 months||0.77|-0.16|0.1948
72438471|NCT03351075|144390392|SUPERIORITY||Mean Difference (Net)|0.17||||0.4937|TWO_SIDED|95.0|-0.31|0.65|||Multivariate linear model|||Difference in change in conditioned pain modulation from baseline to 1 year||0.65|-0.31|0.4937
72438472|NCT03351075|144390392|SUPERIORITY||Mean Difference (Net)|0.23||||0.369|TWO_SIDED|95.0|-0.27|0.73|||Multivariate linear model|A multivariate linear model for longitudinal measures with an unstructured covariance matrix was applied for each continuous outcome.||Difference in change in conditioned pain modulation from baseline to 1.5 years||0.73|-0.27|0.3690
72385917|NCT01044706|144279404|NON_INFERIORITY_OR_EQUIVALENCE|The ANOVA model was utilized in comparing the effects between the test and reference produts. Differences were declared statistically significant at the 5% level (p\<0.05).|ratio of T/R geometric mean x 100|108.46|STANDARD_ERROR_OF_MEAN|0.0321|<|0.05|TWO_SIDED|90.0|102.79|114.44||Differences were declared statistically significant at the 5% level (p\<0.05).|ANOVA|degrees of freedom 55|Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean for AUCO-144 and Cmax between the test and reference product fall within the interval of 80-125%.|Using GLM procedures in SAS, ANOVA was performed on ln-transformed AUC0-144 at the alpha level of 0.05. Factors incorporated in the model will include: Group, Treatment and Treatment\*Group. Intra-subject coefficient of variation (CV%) will be estimated. The ratio of means (T/R) and 90% geometric confidence interval for the ratio of means, based on least-squares means from the ANOVA of the ln-transformed data, will be calculated for AUC0-144 hour.||114.44|102.79|<0.05
72385918|NCT01044706|144279405|NON_INFERIORITY_OR_EQUIVALENCE|The ANOVA model was utilized in comparing the effects between the test and reference produts. Differences were declared statistically significant at the 5% level (p\<0.05).|ratio of T/R geometric mean x 100|110.5|STANDARD_ERROR_OF_MEAN|0.0281|<|0.05|TWO_SIDED|95.0|105.43|115.82||Differences were declared statistically significant at the 5% level (p\<0.05).|ANOVA|degrees of freedom 56|Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean for AUCO-144 and Cmax between the test and reference product fall within the interval of 80-125%.|Using GLM procedures in SAS, ANOVA was performed on ln-transformed Cmax at the alpha level of 0.05. Factors incorporated in the model will include: Group, Treatment and Treatment\*Group. Intra-subject coefficient of variation (CV%) will be estimated. The ratio of means (T/R) and 90% geometric confidence interval for the ratio of means, based on least-squares means from the ANOVA of the ln-transformed data, will be calculated for Cmax.||115.82|105.43|<0.05
72385919|NCT02913612|144279415|SUPERIORITY||Odds Ratio, log|2.65||||0.0205|TWO_SIDED|95.0|1.12|6.26|||Fisher Exact|||||6.26|1.12|0.0205
72385920|NCT02913612|144279415|SUPERIORITY||Odds Ratio, log|2.16||||0.0619|TWO_SIDED|95.0|0.91|5.14|||Fisher Exact|||||5.14|0.91|0.0619
72385921|NCT02913612|144279415|SUPERIORITY||Odds Ratio, log|1.23||||0.6281|TWO_SIDED|95.0|0.53|2.82|||Fisher Exact|||||2.82|0.53|0.6281
72385922|NCT03841448|144279444|SUPERIORITY||Placebo-adjusted GM Percent Change|-37.367||||0.1032|TWO_SIDED|90.0|-60.951|0.46|||MMRM||Placebo-adjusted GM percent change, 90% CIs were calculated by exponentially back-transforming the model based LS mean difference (cemdisiran - placebo) and the corresponding 90% CI then subtracting by 1.|||0.460|-60.951|0.1032
72385923|NCT03841448|144279445|SUPERIORITY||Placebo-adjusted GM Percent Change|-36.167||||0.1432|TWO_SIDED|90.0|-61.552|5.978|||MMRM||Placebo-adjusted GM percent change, 90% CIs were calculated by exponentially back-transforming the model based LS mean difference (cemdisiran - placebo) and the corresponding 90% CI then subtracting by 1.|||5.978|-61.552|0.1432
72385924|NCT03841448|144279446|SUPERIORITY||Odds Ratio (OR)|3.01||||0.1177|TWO_SIDED|90.0|0.43|21.27|||Cochran-Mantel-Haenszel|p-value was based on Cochran-Mantel-Haenszel test stratified by baseline 24-hour UP (≥1.0 g and \<2 g/day versus ≥2.0 g/day).|Odds ratio was estimated with logit method using a correction of 0.5 in every cell of the 2x2 table that contains a zero.|||21.27|0.43|0.1177
72385925|NCT03841448|144279446|SUPERIORITY||Difference in Proportions|0.23|||||TWO_SIDED|90.0|-0.13|0.42|||||Difference in proportions (cemdisiran - placebo) (90% CI) was based on the Wilson score method with continuity correction.|||0.42|-0.13|
72385926|NCT03841448|144279447|SUPERIORITY||Odds Ratio (OR)|3.02||||0.1533|TWO_SIDED|90.0|0.45|20.34|||Cochran-Mantel-Haenszel|p-value was based on Cochran-Mantel-Haenszel test stratified by baseline 24-hour UP (≥1.0 g and \<2 g/day versus ≥2.0 g/day).|Odds ratio was estimated with logit method using a correction of 0.5 in every cell of the 2x2 table that contains a zero.|||20.34|0.45|0.1533
72385927|NCT03841448|144279447|SUPERIORITY||Difference in Proportions|0.23|||||TWO_SIDED|90.0|-0.13|0.42|||||Difference in proportions (cemdisiran - placebo) (90% CI) was based on the Wilson score method with continuity correction.|||0.42|-0.13|
72385928|NCT03841448|144279448|SUPERIORITY||Placebo-adjusted GM Percent Change|-45.771||||0.0021|TWO_SIDED|90.0|-60.093|-26.309|||MMRM||Placebo-adjusted GM percent change, 90% CIs were calculated by exponentially back-transforming the model based LS means difference (cemdisiran - placebo) and the corresponding 90% CI then subtracting by 1.|||-26.309|-60.093|0.0021
72385929|NCT03181893|144279457|OTHER||Mean Difference (Final Values)|-14.82|STANDARD_ERROR_OF_MEAN|3.183|<|0.0001|TWO_SIDED|90.0|-20.26|-9.37|||LANCOVA-P model|||||-9.37|-20.26|<0.0001
72385930|NCT03181893|144279474|OTHER||Least Squares Mean Difference|10.83|STANDARD_ERROR_OF_MEAN|10.274||0.1537|TWO_SIDED|90.0|-7.1|28.77|||Mixed Models Analysis|||Difference of the active treatment from Placebo at Week 4||28.77|-7.10|0.1537
72385931|NCT03181893|144279474|OTHER||Least Squares Mean Difference|12.5|STANDARD_ERROR_OF_MEAN|10.761||0.1312|TWO_SIDED|90.0|-6.29|31.29|||Mixed Models Analysis|||Difference of the active treatment from Placebo at Week 8||31.29|-6.29|0.1312
72385932|NCT03181893|144279474|OTHER||Least Squares Mean Difference|19.44|STANDARD_ERROR_OF_MEAN|12.161||0.0647|TWO_SIDED|90.0|-1.79|40.68|||Mixed Models Analysis|||Difference of the active treatment from Placebo at Week 12||40.68|-1.79|0.0647
72385933|NCT02128932|144279536|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was concluded if the upper limit of the two-sided 95% confidence interval for the estimated treatment difference between semaglutide 1.0 mg and insulin glargine was below the pre-specified non-inferiority margin (0.3 %).|Treatment difference|-0.81|||<|0.0001|TWO_SIDED|95.0|-0.96|-0.67|||Mixed Models Analysis|||The post baseline responses were analysed using a mixed model for repeated measurements with treatment , country and stratum as fixed factors and baseline value as covariate, all nested within visit.||-0.67|-0.96|<0.0001
72385934|NCT02128932|144279536|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was concluded if the upper limit of the two-sided 95 % confidence interval for the estimated treatment difference between semaglutide 0.5 mg and insulin glargine was below the pre-specified non-inferiority margin (0.3%).|Treatment difference|-0.38|||<|0.0001|TWO_SIDED|95.0|-0.52|-0.24|||Mixed Models Analysis|||The post baseline responses were analysed using a mixed model for repeated meausrements with treatment, country and stratum value as covariate, all nested within visit.||-0.24|-0.52|<0.0001
72438473|NCT03351075|144390393|SUPERIORITY||Mean Difference (Net)|2.24||||0.2915|TWO_SIDED|95.0|-1.94|6.43|||Multivariate linear model|A multivariate linear model for longitudinal measures with an unstructured covariance matrix was applied for each continuous outcome.||Difference in change in self-reported upper limb function from baseline to 4 months||6.43|-1.94|0.2915
72618866|NCT02504775|144768275|NON_INFERIORITY_OR_EQUIVALENCE|Log-transformed PK parameter was compared between products using a linear mixed effects model including terms for product, period, sequence as fixed effect and subject nested within sequence as random effect. Bioequivalence was concluded, when the 90% confidence interval (CI) for the geometric LS mean ratios were fully contained within the predefined equivalence limits of 0.80 to 1.25|Ratio of Averages of Tylenol/Mejoral|106.132|||||TWO_SIDED|90.0|85.151|132.283|||ANOVA|||||132.283|85.151|
72438474|NCT03351075|144390393|SUPERIORITY||Mean Difference (Net)|-1.63||||0.4632|TWO_SIDED|95.0|-6.02|2.75|||Multivariate linear model|A multivariate linear model for longitudinal measures with an unstructured covariance matrix was applied for each continuous outcome.||Difference in change in self-reported upper limb function from baseline to 1 year||2.75|-6.02|0.4632
72438475|NCT03351075|144390393|SUPERIORITY||Mean Difference (Net)|-3.16||||0.1944|TWO_SIDED|95.0|-7.94|1.63|||Multivariate linear model|A multivariate linear model for longitudinal measures with an unstructured covariance matrix was applied for each continuous outcome.||Difference in change in self-reported upper limb function from baseline to 1,5 years||1.63|-7.94|0.1944
72438476|NCT03351075|144390394|SUPERIORITY||Mean Difference (Net)|-293.0||||0.5332|TWO_SIDED|95.0|-1218.0|632.0|||Multivariate linear model|A multivariate linear model for longitudinal measures with an unstructured covariance matrix was applied for each continuous outcome.||Difference in change in step count from baseline to 4 months||632|-1218|0.5332
72438477|NCT03351075|144390394|SUPERIORITY||Mean Difference (Net)|839.0||||0.1201|TWO_SIDED|95.0|-221.0|1900.0|||Multivariate linear model|||Difference in change in step count from baseline to 1 year||1900|-221|0.1201
72438478|NCT03351075|144390395|SUPERIORITY||Mean Difference (Net)|0.831||||0.359|TWO_SIDED|95.0|0.561|1.233|||Multivariate linear model|A multivariate linear model for longitudinal measures with an unstructured covariance matrix was applied for each continuous outcome.||Difference in change in self-reported pain catastrophizing from baseline to 4 months||1.233|0.561|0.3590
72438479|NCT03351075|144390395|SUPERIORITY||Mean Difference (Net)|0.839||||0.3744|TWO_SIDED|95.0|0.57|1.236|||Multivariate linear model|A multivariate linear model for longitudinal measures with an unstructured covariance matrix was applied for each continuous outcome.||Difference in change in self-reported pain catastrophizing from baseline to 1 year||1.236|0.570|0.3744
72438480|NCT03351075|144390395|SUPERIORITY||Median Difference (Net)|0.848||||0.4533|TWO_SIDED|95.0|0.522|1.304|||Multivariate linear model|A multivariate linear model for longitudinal measures with an unstructured covariance matrix was applied for each continuous outcome.||Difference in change in self-reported pain catastrophizing from baseline to 1.5 years||1.304|0.522|0.4533
72438481|NCT03351075|144390396|SUPERIORITY||Mean Difference (Net)|0.862||||0.5018|TWO_SIDED|95.0|0.558|1.33|||MUltivariate linear model|A multivariate linear model for longitudinal measures with an unstructured covariance matrix was applied for each continuous outcome.||Difference in change in self-reported depression from baseline to 4 months||1.330|0.558|0.5018
72438482|NCT03351075|144390396|SUPERIORITY||Mean Difference (Net)|0.808||||0.3362|TWO_SIDED|95.0|0.522|1.248|||Multivariate linear model|A multivariate linear model for longitudinal measures with an unstructured covariance matrix was applied for each continuous outcome.||Difference in change in self-reported depression from baseline to 1 year||1.248|0.522|0.3362
72438483|NCT03351075|144390396|SUPERIORITY||Mean Difference (Net)|0.958||||0.8375|TWO_SIDED|95.0|0.633|1.449|||Multivariate linear model|A multivariate linear model for longitudinal measures with an unstructured covariance matrix was applied for each continuous outcome.||Difference in change in self-reported depression from baseline to 1.5 years||1.449|0.633|0.8375
72438484|NCT03351075|144390397|SUPERIORITY||Mean Difference (Net)|-0.32||||0.1745|TWO_SIDED|95.0|-0.78|0.14|||Multivariate linear model|A multivariate linear model for longitudinal measures with an unstructured covariance matrix was applied for each continuous outcome.||Difference in change in self-reported health-related quality of life from baseline to 4 months||0.14|-0.78|0.1745
72438485|NCT03351075|144390397|SUPERIORITY||Mean Difference (Net)|0.18||||0.5025|TWO_SIDED|95.0|-0.35|0.71|||Multivariate linear model|A multivariate linear model for longitudinal measures with an unstructured covariance matrix was applied for each continuous outcome.||Difference in change in self-reported health-related quality of life from baseline to 1 year||0.71|-0.35|0.5025
72438486|NCT03351075|144390397|SUPERIORITY||Mean Difference (Net)|0.45||||0.1363|TWO_SIDED|95.0|-0.14|1.05|||Multivariate linear model|A multivariate linear model for longitudinal measures with an unstructured covariance matrix was applied for each continuous outcome.||Difference in change in self-reported health-related quality of life from baseline to 1,5 years||1.05|-0.14|0.1363
72438487|NCT03351075|144390398|SUPERIORITY||Percentage|-0.184||||0.074|TWO_SIDED|95.0|-0.358|0.008|||Fisher Exact|||Difference in proportion of working participants at 1 year||0.008|-0.358|0.074
72438488|NCT03351075|144390398|SUPERIORITY||Percentage|-0.09||||0.352|TWO_SIDED|95.0|-0.26|0.078|||Fisher Exact|||Difference in proportion of working participants at 1,5 years||0.078|-0.26|0.352
72438489|NCT03351075|144390399|SUPERIORITY||Mean Difference (Net)|0.23||||0.8497|TWO_SIDED|95.0|-2.17|2.64|||Multivariate linear model|A multivariate linear model for longitudinal measures with an unstructured covariance matrix was applied for each continuous outcome.||Difference in change in cold detection sensitivity from baseline to 4 months||2.64|-2.17|0.8497
72438490|NCT03351075|144390399|SUPERIORITY||Mean Difference (Net)|0.81||||0.4971|TWO_SIDED|95.0|-1.52|3.14|||Multivariate linear model|A multivariate linear model for longitudinal measures with an unstructured covariance matrix was applied for each continuous outcome.||Difference in change in cold detection sensitivity from baseline to 1 year||3.14|-1.52|0.4971
72438491|NCT03351075|144390399|SUPERIORITY||Mean Difference (Net)|0.45||||0.6831|TWO_SIDED|95.0|-1.72|2.62|||Multivariate linear model|A multivariate linear model for longitudinal measures with an unstructured covariance matrix was applied for each continuous outcome.||Difference in change in cold detection sensitivity from baseline to 1.5 years||2.62|-1.72|0.6831
72438492|NCT03351075|144390400|SUPERIORITY||Mean Difference (Net)|4.78||||0.8584|TWO_SIDED|95.0|-47.72|57.28|||Multivariate linear model|A multivariate linear model for longitudinal measures with an unstructured covariance matrix was applied for each continuous outcome.||Difference in change in mechanical pain sensitivity at the arm from baseline to 4 months||57.28|-47.72|0.8584
72438493|NCT03351075|144390400|SUPERIORITY||Mean Difference (Net)|-57.25||||0.0353|TWO_SIDED|95.0|-110.57|-3.93|||Multivariate linear model|A multivariate linear model for longitudinal measures with an unstructured covariance matrix was applied for each continuous outcome.||Difference in change in mechanical pain sensitivity at the arm from baseline to 1 year||-3.93|-110.57|0.0353
72495303|NCT00915343|144519616|SUPERIORITY_OR_OTHER_LEGACY||Mean difference|-0.007||||0.6687|TWO_SIDED|95.0|-0.038|0.024|||Fisher's non-parametric permutation test|||||0.024|-0.038|0.6687
72438494|NCT03351075|144390400|SUPERIORITY||Mean Difference (Net)|-20.1||||0.4865|TWO_SIDED|95.0|-76.72|36.52|||Multivariate linear model|A multivariate linear model for longitudinal measures with an unstructured covariance matrix was applied for each continuous outcome.||Difference in change in mechanical pain sensitivity at the arm from baseline to 1.5 years||36.52|-76.72|0.4865
72438495|NCT03351075|144390401|SUPERIORITY||Mean Difference (Net)|1.11||||0.1278|TWO_SIDED|95.0|0.97|1.27|||Multivariate linear model|A multivariate linear model for longitudinal measures with an unstructured covariance matrix was applied for each continuous outcome.||Difference in change in pressure pain sensitivity at the pectoral region from baseline to 4 months||1.27|0.97|0.1278
72495304|NCT00915343|144519617|SUPERIORITY_OR_OTHER_LEGACY||Mean difference|0.049||||0.028|TWO_SIDED|95.0|0.006|0.093|||Fisher's non-parametric permutation test|||||0.093|0.006|0.0280
72495305|NCT00915343|144519618|SUPERIORITY_OR_OTHER_LEGACY||Mean difference|5.509||||0.0003|TWO_SIDED|95.0|0.751|10.268|||Fisher's non-parametric permutation test|||||10.268|0.751|0.0003
72495306|NCT00915343|144519619|SUPERIORITY_OR_OTHER_LEGACY||Mean difference|-13.8|||<|0.0001|TWO_SIDED|95.0|-20.533|-7.067|||Fisher's non-parametric permutation test|||||-7.067|-20.533|<0.0001
72495307|NCT00915343|144519620|SUPERIORITY_OR_OTHER_LEGACY||Period-adjusted quotient|1.064||||0.0002|TWO_SIDED|95.0|1.032|1.097|||ANOVA||The quotient was defined as AUC0-4h for OD treatment divided by AUC0-4h for TID treatment.|AUC0-4h||1.097|1.032|0.0002
72495308|NCT00915343|144519620|SUPERIORITY_OR_OTHER_LEGACY||Period-adjusted quotient|0.617|||<|0.0001|TWO_SIDED|95.0|0.563|0.675|||ANOVA||The quotient was defined as AUC4-12h for OD treatment divided by AUC4-12h for TID treatment.|AUC4-12h||0.675|0.563|<0.0001
72495309|NCT00915343|144519620|SUPERIORITY_OR_OTHER_LEGACY||Period-adjusted quotient|0.472|||<|0.0001|TWO_SIDED|95.0|0.424|0.525|||ANOVA||The quotient was defined as AUC6-12h for OD treatment divided by AUC6-12h for TID treatment.|AUC6-12h||0.525|0.424|<0.0001
72495310|NCT00915343|144519620|SUPERIORITY_OR_OTHER_LEGACY||Period-adjusted quotient|0.588||||0.0003|TWO_SIDED|95.0|0.446|0.775|||ANOVA||The quotient was defined as AUC12-24h for OD treatment divided by AUC12-24h for TID treatment.|AUC12-24h||0.775|0.446|0.0003
72495311|NCT00915343|144519620|SUPERIORITY_OR_OTHER_LEGACY||Period-adjusted quotient|0.894|||<|0.0001|TWO_SIDED|95.0|0.856|0.935|||ANOVA||The quotient was defined as AUC0-10h for OD treatment divided by AUC0-10h for TID treatment.|AUC0-10h||0.935|0.856|<0.0001
72495312|NCT00915343|144519620|SUPERIORITY_OR_OTHER_LEGACY||Period-adjusted quotient|0.695|||<|0.0001|TWO_SIDED|95.0|0.632|0.765|||ANOVA||The quotient was defined as AUC4-10h for OD treatment divided by AUC4-10h for TID treatment.|AUC4-10h||0.765|0.632|<0.0001
72495313|NCT00915343|144519620|SUPERIORITY_OR_OTHER_LEGACY||Period-adjusted quotient|0.54|||<|0.0001|TWO_SIDED|95.0|0.482|0.605|||ANOVA||The quotient was defined as AUC6-10h for OD treatment divided by AUC6-10h for TID treatment.|AUC6-10h||0.605|0.482|<0.0001
72495314|NCT00915343|144519620|SUPERIORITY_OR_OTHER_LEGACY||Period-adjusted quotient|0.412|||<|0.0001|TWO_SIDED|95.0|0.338|0.504|||ANOVA||The quotient was defined as AUC10-24h for OD treatment divided by AUC10-24h for TID treatment.|AUC10-24h||0.504|0.338|<0.0001
72438496|NCT03351075|144390401|SUPERIORITY||Mean Difference (Net)|1.11||||0.1875|TWO_SIDED|95.0|0.95|1.3|||Multivariate linear model|A multivariate linear model for longitudinal measures with an unstructured covariance matrix was applied for each continuous outcome.||Difference in change in pressure pain sensitivity at the pectoral region from baseline to 1 year||1.30|0.95|0.1875
72495315|NCT00915343|144519620|SUPERIORITY_OR_OTHER_LEGACY||Period-adjusted quotient|0.776|||<|0.0001|TWO_SIDED|95.0|0.714|0.843|||ANOVA||The quotient was defined as AUC(0-inf) for OD treatment divided by AUC(0-inf) for TID treatment.|AUC(0-inf)||0.843|0.714|<0.0001
72495316|NCT00915343|144519620|SUPERIORITY_OR_OTHER_LEGACY||Period-adjusted quotient|1.069||||0.877|TWO_SIDED|95.0|0.453|2.521|||ANOVA||The quotient was defined as AUC(24h-inf) for OD treatment divided by AUC(24h-inf) for TID treatment.|AUC(24h-inf)||2.521|0.453|0.8770
72495317|NCT00915343|144519621|SUPERIORITY_OR_OTHER_LEGACY||Period-adjusted quotient|0.806|||<|0.0001|TWO_SIDED|95.0|0.753|0.862|||ANOVA||The quotient was defined as AUCtau for OD treatment divided by AUCtau for TID treatment.|||0.862|0.753|<0.0001
72495318|NCT00915343|144519622|SUPERIORITY_OR_OTHER_LEGACY||Period-adjusted quotient|0.79|||<|0.0001|TWO_SIDED|95.0|0.734|0.851|||ANOVA||The quotient was defined as AUCtau/dose for OD treatment divided by AUCtau/dose for TID treatment.|||0.851|0.734|<0.0001
72495319|NCT00915343|144519623|SUPERIORITY_OR_OTHER_LEGACY||Period-adjusted quotient|0.785|||<|0.0001|TWO_SIDED|95.0|0.741|0.831|||ANOVA||The quotient was defined as AUC0-24h/dose for OD treatment divided by AUC0-24h/dose for TID treatment.|||0.831|0.741|<0.0001
72495320|NCT00915343|144519624|SUPERIORITY_OR_OTHER_LEGACY||Period-adjusted quotient|0.885|||<|0.0001|TWO_SIDED|95.0|0.844|0.926|||ANOVA||The quotient was defined as AUC0-10h/dose for OD treatment divided by AUC0-10h/dose for TID treatment.|||0.926|0.844|<0.0001
72495321|NCT00915343|144519625|SUPERIORITY_OR_OTHER_LEGACY||Period-adjusted quotient|1.053||||0.002|TWO_SIDED|95.0|1.02|1.086|||ANOVA||The quotient was defined as AUC0-4h/dose for OD treatment divided by AUC0-4h/dose for TID treatment.|||1.086|1.020|0.0020
72495322|NCT00915343|144519626|SUPERIORITY_OR_OTHER_LEGACY||Mean difference|-0.001|||<|0.0001|TWO_SIDED|95.0|-0.001|0.0|||Fisher's non-parametric permutation test|||||-0.000|-0.001|<0.0001
72495323|NCT00915343|144519627|SUPERIORITY_OR_OTHER_LEGACY||Mean difference|-0.001|||<|0.0001|TWO_SIDED|95.0|-0.002|-0.001|||Fisher's non-parametric permutation test|||||-0.001|-0.002|<0.0001
72495324|NCT00915343|144519628|SUPERIORITY_OR_OTHER_LEGACY||Mean difference|-0.055||||0.7827|TWO_SIDED|95.0|-0.444|0.334|||Fisher's non-parametric permutation test|||||0.334|-0.444|0.7827
72495325|NCT00915343|144519629|SUPERIORITY_OR_OTHER_LEGACY||Mean difference|-0.001||||0.0015|TWO_SIDED|95.0|-0.001|0.0|||Fisher's non-parametric permutation test|||||-0.000|-0.001|0.0015
72495326|NCT00915343|144519630|SUPERIORITY_OR_OTHER_LEGACY||Period-adjusted quotient|6.098|||<|0.0001|TWO_SIDED|95.0|2.94|12.646|||ANOVA||The quotient was defined as AUC Extrapolation for OD treatment divided by AUC Extrapolation for TID treatment.|||12.646|2.940|<0.0001
72495327|NCT00915343|144519631|SUPERIORITY_OR_OTHER_LEGACY||Mean difference|33.532||||0.0396|TWO_SIDED|95.0|1.734|65.329|||Fisher's non-parametric permutation test|||||65.329|1.734|0.0396
72495328|NCT00915343|144519632|SUPERIORITY_OR_OTHER_LEGACY||Period-adjusted quotient|0.08||||0.1032|TWO_SIDED|95.0|-0.017|0.177|||Fisher's non-parametric permutation test|||||0.177|-0.017|0.1032
72495329|NCT00915343|144519633|SUPERIORITY_OR_OTHER_LEGACY||least square mean|-0.078||||0.3767|TWO_SIDED|95.0|-0.25|0.094|||Fisher's test|Fisher's non||Patient||0.094|-0.250|0.3767
72618867|NCT01230814|144768278|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.92||||0.69|TWO_SIDED|95.0|0.62|1.37||The a priori threshold for statistical significance for VVC was p\<0.020 (two-sided).|Clustered chi-squared statistic||For the relative risk estimate, the metronidazole plus miconazole arm represented the numerator and the placebo arm represented the denominator such that a relative risk \<1 indicates a lower percentage of positive test visits in the treated arm.|Each participant within a study arm was considered a cluster, with observations at a maximum of 6 visits. The percentage of visits at which VVC was detected was compared between metronidazole plus miconazole arm versus placebo arm using a chi-squared statistic adjusted for clustering using the method of Donner and Klar (2000).||1.37|0.62|0.690
72438497|NCT03351075|144390401|SUPERIORITY||Mean Difference (Net)|1.05||||0.5612|TWO_SIDED|95.0|0.89|1.23|||Multivariate linear model|A multivariate linear model for longitudinal measures with an unstructured covariance matrix was applied for each continuous outcome.||Difference in change in pressure pain sensitivity at the pectoral region from baseline to 1.5 years||1.23|0.89|0.5612
72438498|NCT03351075|144390402|SUPERIORITY||Mean Difference (Net)|1.089||||0.7902|TWO_SIDED|95.0|0.693|1.62|||Multivariate linear model|A multivariate linear model for longitudinal measures with an unstructured covariance matrix was applied for each continuous outcome.||Difference in change in self-reported anxiety from baseline to 4 months||1.620|0.693|0.7902
72438499|NCT03351075|144390402|SUPERIORITY||Mean Difference (Net)|0.934||||0.7578|TWO_SIDED|95.0|0.604|1.443|||Multivariate linear model|A multivariate linear model for longitudinal measures with an unstructured covariance matrix was applied for each continuous outcome.||Difference in change in self-reported anxiety from baseline to 1 year||1.443|0.604|0.7578
72438500|NCT03351075|144390402|SUPERIORITY||Mean Difference (Net)|1.01||||0.96|TWO_SIDED|95.0|0.679|1.504|||Multivariate linear model|A multivariate linear model for longitudinal measures with an unstructured covariance matrix was applied for each continuous outcome.||Difference in change in self-reported anxiety from baseline to 1.5 years||1.504|0.679|0.9600
72438501|NCT03351075|144390403|SUPERIORITY||Mean Difference (Net)|1.068||||0.7619|TWO_SIDED|95.0|0.696|1.639|||Multivariate linear model|multivariate linear model for longitudinal measures with an unstructured covariance matrix was applied for each continuous outcome.||Difference in change in self-reported stress from baseline to 4 months||1.639|0.696|0.7619
72438502|NCT03351075|144390403|SUPERIORITY||Mean Difference (Net)|1.087||||0.7169|TWO_SIDED|95.0|0.702|1.673|||Multivariate linear model|A multivariate linear model for longitudinal measures with an unstructured covariance matrix was applied for each continuous outcome.||Difference in change in self-reported stress from baseline to 1 year||1.673|0.702|0.7169
72438503|NCT03351075|144390403|SUPERIORITY||Mean Difference (Net)|0.987||||0.9535|TWO_SIDED|95.0|0.639|1.525|||Multivariate linear model|A multivariate linear model for longitudinal measures with an unstructured covariance matrix was applied for each continuous outcome.||Difference in change in self-reported stress from baseline to 1.5 years||1.525|0.639|0.9535
72438504|NCT05219253|144390409|SUPERIORITY|The superiority was to be concluded if the lower limit (LL) of the 95% confidence interval (CI) of the adjusted GMC ratio between the HZ/su Group and Placebo Group for anti-gE antibody concentrations was equal to or above (\>=) 3.|GMC Ratio|19.8|||||TWO_SIDED|95.0|14.09|27.82|||ANOVA|||To demonstrate the immunogenicity of HZ/su vaccine compared to Placebo, in terms of anti-gE GMCs, at 1 month post-Dose 2 of study intervention administration (Month 3).||27.82|14.09|
72438505|NCT03086369|144390421|SUPERIORITY||Hazard Ratio (HR)|1.054||||0.7902|TWO_SIDED|95.0|0.728|1.527|||Log Rank|Stratified by age group (\<70 years versus ≥70 years) and prior adjuvant/neo-adjuvant gemcitabine use (yes vs no).|Stratified by age group (\<70 years versus ≥70 years) and prior adjuvant/neo-adjuvant gemcitabine use (yes vs no).|||1.527|0.728|0.7902
72438506|NCT03086369|144390425|SUPERIORITY||Hazard Ratio (HR)|1.192||||0.3771|TWO_SIDED|95.0|0.806|1.764|||Log Rank|Stratified by age group (\<70 years versus ≥70 years) and prior adjuvant/neo-adjuvant gemcitabine use (yes vs no).|Stratified by age group (\<70 years versus ≥70 years) and prior adjuvant/neo-adjuvant gemcitabine use (yes vs no).|||1.764|0.806|0.3771
72438507|NCT03086369|144390428|SUPERIORITY||Hazard Ratio (HR)|0.39||||0.017|TWO_SIDED|95.0|0.175|0.872|||Log Rank|Stratified by age group (\<70 years versus ≥70 years) and prior adjuvant/neo-adjuvant gemcitabine use (yes vs no).||||0.872|0.175|0.017
72438508|NCT03086369|144390429|SUPERIORITY||Hazard Ratio (HR)|0.718||||0.288|TWO_SIDED|95.0|0.392|1.317|||Log Rank|Stratified by age group (\<70 years versus ≥70 years) and prior adjuvant/neo-adjuvant gemcitabine use (yes vs no).|Stratified by age group (\<70 years versus ≥70 years) and prior adjuvant/neo-adjuvant gemcitabine use (yes vs no).|Appetite loss||1.317|0.392|0.288
72438509|NCT03086369|144390429|SUPERIORITY||Hazard Ratio (HR)|0.788||||0.442|TWO_SIDED|95.0|0.423|1.468|||Log Rank|Stratified by age group (\<70 years versus ≥70 years) and prior adjuvant/neo-adjuvant gemcitabine use (yes vs no).|Stratified by age group (\<70 years versus ≥70 years) and prior adjuvant/neo-adjuvant gemcitabine use (yes vs no).|Constipation||1.468|0.423|0.442
72438510|NCT03086369|144390429|SUPERIORITY||Hazard Ratio (HR)|1.037||||0.883|TWO_SIDED|95.0|0.612|1.755|||Log Rank|Stratified by age group (\<70 years versus ≥70 years) and prior adjuvant/neo-adjuvant gemcitabine use (yes vs no).|Stratified by age group (\<70 years versus ≥70 years) and prior adjuvant/neo-adjuvant gemcitabine use (yes vs no).|Diarrhoea||1.755|0.612|0.883
72438511|NCT03086369|144390429|SUPERIORITY||Hazard Ratio (HR)|0.933||||0.803|TWO_SIDED|95.0|0.532|1.636|||Log Rank|Stratified by age group (\<70 years versus ≥70 years) and prior adjuvant/neo-adjuvant gemcitabine use (yes vs no).|Stratified by age group (\<70 years versus ≥70 years) and prior adjuvant/neo-adjuvant gemcitabine use (yes vs no).|Dyspnoea||1.636|0.532|0.803
72438512|NCT03086369|144390429|SUPERIORITY||Hazard Ratio (HR)|1.053||||0.805|TWO_SIDED|95.0|0.675|1.645|||Log Rank|Stratified by age group (\<70 years versus ≥70 years) and prior adjuvant/neo-adjuvant gemcitabine use (yes vs no).|Stratified by age group (\<70 years versus ≥70 years) and prior adjuvant/neo-adjuvant gemcitabine use (yes vs no).|Fatigue||1.645|0.675|0.805
72438513|NCT03086369|144390429|SUPERIORITY||Hazard Ratio (HR)|0.784||||0.465|TWO_SIDED|95.0|0.42|1.464|||Log Rank|Stratified by age group (\<70 years versus ≥70 years) and prior adjuvant/neo-adjuvant gemcitabine use (yes vs no).|Stratified by age group (\<70 years versus ≥70 years) and prior adjuvant/neo-adjuvant gemcitabine use (yes vs no).|Financial difficulties||1.464|0.420|0.465
72495330|NCT00915343|144519633|SUPERIORITY_OR_OTHER_LEGACY||least square mean|-0.064||||0.4625|TWO_SIDED|95.0|-0.235|0.107|||Fisher's test|Fisher's non||Investigator||0.107|-0.235|0.4625
72495331|NCT00915343|144519634|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6072|TWO_SIDED||||||Sign test|||Patient||||0.6072
72495332|NCT00915343|144519634|SUPERIORITY_OR_OTHER_LEGACY|||||||1|TWO_SIDED||||||Sign test|||Investigator||||1.0000
72385935|NCT01361568|144279544|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.96|STANDARD_ERROR_OF_MEAN|3.64|<|0.05|TWO_SIDED|95.0|-15.14|-0.78|||t-test, 2 sided|||||-0.78|-15.14|<0.05
72385936|NCT01361568|144279545|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-420.0|STANDARD_ERROR_OF_MEAN|139.16|<|0.01||95.0|||||t-test, 2 sided|||||||<0.01
72385937|NCT01361568|144279545|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-230.1|STANDARD_ERROR_OF_MEAN|92.26|<|0.05||95.0|||||t-test, 2 sided|||||||<0.05
72385938|NCT01361568|144279545|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-260.4|STANDARD_ERROR_OF_MEAN|141.99||0.068||95.0|||||t-test, 2 sided|||||||0.068
72385939|NCT01361568|144279546|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-6.39|STANDARD_ERROR_OF_MEAN|2.63|<|0.05||95.0|||||Mixed Models Analysis|||||||<0.05
72385940|NCT01361568|144279546|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-3.31|STANDARD_ERROR_OF_MEAN|1.74||0.059||95.0|||||Mixed Models Analysis|||||||0.059
72385941|NCT01361568|144279547|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.0|STANDARD_ERROR_OF_MEAN|0.41|<|0.05|TWO_SIDED|95.0|0.22|1.82|||t-test, 2 sided|||||1.82|0.22|<0.05
72385942|NCT01361568|144279547|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.6|STANDARD_ERROR_OF_MEAN|0.27|<|0.05|TWO_SIDED|95.0|0.11|1.17|||t-test, 2 sided|||||1.17|0.11|<0.05
72385943|NCT01361568|144279548|SUPERIORITY_OR_OTHER|||||||0.001|||||||Chi-squared|Degrees of freedom (df = 1)||||||0.001
72385944|NCT01361568|144279549|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Fisher Exact|||||||<0.001
72385945|NCT01361568|144279550|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Fisher Exact|||||||<0.05
72385946|NCT00657358|144279552|SUPERIORITY_OR_OTHER||R^2 (adj)|0.477|||<|0.001|TWO_SIDED|95.0|||||Regression, Linear|DF=2 DFDEN=371.8, F-ratio=10.66||||||<0.001
72385947|NCT02959983|144279557|SUPERIORITY|||||||0.0022|||||||Chi-squared|||Overall Weeks 1-12||||0.0022
72385948|NCT02959983|144279558|SUPERIORITY|||||||0.0119|||||||Chi-squared|||Overall Weeks 1 to 12||||0.0119
72385949|NCT02959983|144279558|SUPERIORITY|||||||0.0048|||||||Chi-squared|||Weeks 1 to 4||||0.0048
72385950|NCT02959983|144279558|SUPERIORITY|||||||0.0207|||||||Chi-squared|||Weeks 5 to 8||||0.0207
72385951|NCT02959983|144279558|SUPERIORITY|||||||0.37|||||||Chi-squared|||Weeks 9 to 12||||0.3700
72385952|NCT02959983|144279559|SUPERIORITY|||||||0.0174|||||||Chi-squared|||Overall Weeks 1 to 12||||0.0174
72385953|NCT02959983|144279559|SUPERIORITY|||||||0.3832|||||||Chi-squared|||Weeks 1 to 4||||0.3832
72385954|NCT02959983|144279559|SUPERIORITY|||||||0.0052|||||||Chi-squared|||Weeks 5 to 8||||0.0052
72385955|NCT02959983|144279559|SUPERIORITY|||||||0.0619|||||||Chi-squared|||Weeks 9 to 12||||0.0619
72385956|NCT02959983|144279560|SUPERIORITY|||||||0.033|||||||Chi-squared|||Weeks 1-4||||0.0330
72385957|NCT02959983|144279560|SUPERIORITY|||||||0.0063|||||||Chi-squared|||Weeks 5 to 8||||0.0063
72385958|NCT02959983|144279560|SUPERIORITY|||||||0.0018|||||||Chi-squared|||Weeks 9 to 12||||0.0018
72385959|NCT02728596|144279561|SUPERIORITY||Odds Ratio (OR)|0.44||||0.21|TWO_SIDED|95.0|0.12|1.57|||Regression, Logistic|Adjusted for age group, comorbidity, race, and Hispanic ethnicity.||PP-CSF use in the high risk FN group was compared between the usual care (UC) group (Arm 2) and the intervention group (Arm 3 and 4 combined).||1.57|0.12|0.21
72385960|NCT02728596|144279561|SUPERIORITY||Odds Ratio (OR)|1.18||||0.74|TWO_SIDED|95.0|0.44|3.2|||Regression, Logistic|Adjusted for age, sex, and cancer type.||PP-CSF use in the low risk FN group was compared between the usual care (UC) group (Arm 2) and the intervention group (Arm 3 and 4 combined).||3.20|0.44|0.74
72385961|NCT02728596|144279561|SUPERIORITY||Odds Ratio (OR)|2.23||||0.17|TWO_SIDED|95.0|0.7|7.08|||Regression, Logistic|Adjusted for age, sex, and cancer type.||PP-CSF use in the intermediate risk FN group was compared between the usual care (UC) group (Arm 2) and the SOE for PP-CSF intervention group (Arm 3).||7.08|0.70|0.17
72385962|NCT02728596|144279561|SUPERIORITY||Odds Ratio (OR)|0.36||||0.094|TWO_SIDED|95.0|0.11|1.19|||Regression, Logistic|Adjusted for age, sex, and cancer type.||PP-CSF use in the intermediate risk FN group was compared between the usual care (UC) group (Arm 2) and the alert against PP-CSF intervention group (Arm 4).||1.19|0.11|0.094
72385963|NCT02728596|144279562|SUPERIORITY||Odds Ratio (OR)|1.49||||0.26|TWO_SIDED|95.0|0.75|2.95|||Regression, Logistic|Adjusted for age.||FN incidence rate in the high risk FN group was compared between the usual care (UC) group (Arm 2) and the intervention group (Arm 3 and 4 combined).||2.95|0.75|0.26
72385964|NCT02728596|144279562|SUPERIORITY||Odds Ratio (OR)|2.0||||0.51|TWO_SIDED|95.0|0.23|18.8|||Regression, Logistic|Adjusted for cancer type.||FN incidence rate in the low risk FN group was compared between the usual care (UC) group (Arm 2) and the intervention group (Arm 3 and 4 combined).||18.80|0.23|0.51
72385965|NCT02728596|144279562|SUPERIORITY||Odds Ratio (OR)|1.09||||0.87|TWO_SIDED|95.0|0.41|2.88|||Regression, Logistic|||FN incidence rate in the intermediate risk FN group was compared between the usual care (UC) group (Arm 2) and the SOE for PP-CSF intervention group (Arm 3).||2.88|0.41|0.87
72385966|NCT02728596|144279562|SUPERIORITY||Odds Ratio (OR)|1.25||||0.68|TWO_SIDED|95.0|0.44|3.57|||Regression, Logistic|||FN incidence rate in the intermediate risk FN group was compared between the usual care (UC) group (Arm 2) and the alert against PP-CSF intervention group (Arm 4).||3.57|0.44|0.68
72385967|NCT02728596|144279563|SUPERIORITY||Odds Ratio (OR)|0.87||||0.74|TWO_SIDED|95.0|0.39|1.95|||Regression, Logistic|Adjusted for cancer type.||||1.95|0.39|0.74
72385968|NCT02728596|144279563|SUPERIORITY||Odds Ratio (OR)|1.09||||0.87|TWO_SIDED|95.0|0.41|2.88|||Regression, Logistic|Adjusted for cancer type.||||2.88|0.41|0.87
72385969|NCT02728596|144279563|SUPERIORITY||Odds Ratio (OR)|1.25||||0.68|TWO_SIDED|95.0|0.44|3.57|||Regression, Logistic|Adjusted for cancer type.||This is comparing the FN incidence rate in the arm randomized to alert against PP-CSF vs usual care in intermediate risk participants.||3.57|0.44|0.68
72385970|NCT03221270|144279575|SUPERIORITY|alternative hypothesis: true difference in means is greater than 0|Median Difference (Final Values)|-0.43||||0.66|ONE_SIDED|95.0|-2.25||||t-test, 1 sided||||||-2.25|0.66
72618868|NCT01230814|144768279|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.65||||0.005|TWO_SIDED|95.0|0.48|0.87||The a priori threshold for statistical significance for BV was p\<0.030 (two-sided).|clutstered chi-squared statistic||For the relative risk estimate, the metronidazole plus miconazole arm represented the numerator and the placebo arm represented the denominator such that a relative risk \<1 indicates a lower percentage of test visits in the treated arm.|Each participant within a study arm was considered a cluster, with observations at a maximum of 6 visits. The percentage of visits at which BV was detected was compared between metronidazole plus miconazole arm versus placebo arm using a chi-squared statistic adjusted for clustering using the method of Donner and Klar (2000).||0.87|0.48|0.005
72618869|NCT01260324|144768301|SUPERIORITY_OR_OTHER_LEGACY||Incidence rate per 1000 person-years|0.01|||||TWO_SIDED|95.0|0.01|0.01|||||Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.|Incidence rate Age 18 to 34||0.01|0.01|
72618870|NCT01260324|144768301|SUPERIORITY_OR_OTHER_LEGACY||Incidence rate per 1000 person-years|0.01|||||TWO_SIDED|95.0|0.01|0.01|||||Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.|Incidence rate Age 35 to 44||0.01|0.01|
72618871|NCT01260324|144768301|SUPERIORITY_OR_OTHER_LEGACY||Incidence rate per 1000 person-years|0.03|||||TWO_SIDED|95.0|0.03|0.04|||||Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.|Incidence rate Age 45 to 54||0.04|0.03|
72618872|NCT01260324|144768301|SUPERIORITY_OR_OTHER_LEGACY||Incidence rate per 1000 person-years|0.08|||||TWO_SIDED|95.0|0.07|0.09|||||Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.|Incidence rate Age 55 to 64||0.09|0.07|
72618873|NCT01260324|144768301|SUPERIORITY_OR_OTHER_LEGACY||Incidence rate per 1000 person-years|0.12|||||TWO_SIDED|95.0|0.11|0.14|||||Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.|Incidence rate Age 65 to 74||0.14|0.11|
72438514|NCT03086369|144390429|SUPERIORITY||Hazard Ratio (HR)|1.457||||0.231|TWO_SIDED|95.0|0.787|2.698|||Log Rank|Stratified by age group (\<70 years versus ≥70 years) and prior adjuvant/neo-adjuvant gemcitabine use (yes vs no).|Stratified by age group (\<70 years versus ≥70 years) and prior adjuvant/neo-adjuvant gemcitabine use (yes vs no).|Insomnia||2.698|0.787|0.231
72438515|NCT03086369|144390429|SUPERIORITY||Hazard Ratio (HR)|0.914||||0.748|TWO_SIDED|95.0|0.532|1.57|||Log Rank|Stratified by age group (\<70 years versus ≥70 years) and prior adjuvant/neo-adjuvant gemcitabine use (yes vs no).|Stratified by age group (\<70 years versus ≥70 years) and prior adjuvant/neo-adjuvant gemcitabine use (yes vs no).|Nausea and vomiting||1.570|0.532|0.748
72438516|NCT03086369|144390429|SUPERIORITY||Hazard Ratio (HR)|0.947||||0.875|TWO_SIDED|95.0|0.491|1.827|||Log Rank|Stratified by age group (\<70 years versus ≥70 years) and prior adjuvant/neo-adjuvant gemcitabine use (yes vs no).|Stratified by age group (\<70 years versus ≥70 years) and prior adjuvant/neo-adjuvant gemcitabine use (yes vs no).|Pain||1.827|0.491|0.875
72438517|NCT04603924|144390443|OTHER||||||||||||||||||"For the analysis of this efficacy endpoint, missing scores of the WHO Ordinal Scale for Clinical Improvement will be assumed to be \> 2 (i.e., no hospital discharge). Median time-to-clinical improvement and corresponding 95% confidence interval were estimated from the Kaplan-Meier curves. In some cases the 95% confidence interval was Not Evaluable (NE) by this method."|||
72438518|NCT04603924|144390444|OTHER||||||||||||||||||"For the analysis of this efficacy endpoint, missing scores of the WHO Ordinal Scale for Clinical Improvement were be assumed to be \> 2 (i.e., no hospital discharge). Median number of days to a 2-point improvement and corresponding 95% confidence interval were estimated from the Kaplan-Meier curves.~In some cases the 95% confidence interval was Not Evaluable (NE) by this method."|||
72438519|NCT01904071|144390458|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||||||<.0001
72438520|NCT01904071|144390459|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<.05
72438521|NCT01904071|144390460|SUPERIORITY_OR_OTHER||||||<|0.005|||||||ANOVA|||||||<.005
72438522|NCT01904071|144390461|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA|||||||<.001
72618874|NCT01260324|144768301|SUPERIORITY_OR_OTHER_LEGACY||Incidence rate per 1000 person-years|0.18|||||TWO_SIDED|95.0|0.15|0.21|||||Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.|Incidence rate Age ≥75||0.21|0.15|
72618875|NCT01260324|144768301|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.09|||||TWO_SIDED|95.0|0.06|0.13|||||Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.|Odds ratio Age 18 to 34||0.13|0.06|
72618876|NCT01260324|144768301|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.11|||||TWO_SIDED|95.0|0.08|0.16|||||Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.|Odds ratio Age 35 to 44||0.16|0.08|
72618877|NCT01260324|144768301|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.37|||||TWO_SIDED|95.0|0.3|0.45|||||Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.|Odds ratio Age 45 to 54||0.45|0.30|
72618878|NCT01260324|144768301|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|3.83|||||TWO_SIDED|95.0|2.68|5.47|||||Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.|Odds ratio Age 65 to 74||5.47|2.68|
72438523|NCT01904071|144390462|SUPERIORITY_OR_OTHER|||||||0.342|||||||ANOVA|||||||0.342
72438524|NCT01424397|144390475|SUPERIORITY_OR_OTHER||||||||||||||||||Bayesian analysis: The posterior probability of a reduction in TNSS with FP alone compared to Placebo using Mixed Models Analysis was 1.0000|||
72438525|NCT01424397|144390475|SUPERIORITY_OR_OTHER||||||||||||||||||Bayesian analysis: The posterior probability of a reduction in TNSS with SB-705498 alone compared to Placebo using Mixed Models Analysis was 0.7127|||
72438526|NCT01424397|144390475|SUPERIORITY_OR_OTHER||||||||||||||||||Bayesian analysis: The posterior probability of a reduction in TNSS with SB-705498 + FP compared to Placebo using Mixed Models Analysis was 1.0000|||
72438527|NCT01424397|144390475|SUPERIORITY_OR_OTHER||||||||||||||||||Bayesian analysis: The posterior probability of a reduction in TNSS with SB-705498 + FP compared to FP alone using Mixed Models Analysis was 0.0160|||
72618879|NCT01260324|144768301|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|5.73|||||TWO_SIDED|95.0|4.0|8.22|||||Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.|Odds ratio Age ≥75||8.22|4.00|
72385971|NCT02495831|144279621|SUPERIORITY_OR_OTHER||point estimate (ratio of geometric means|90.0||||0.1|TWO_SIDED|90.0|80.0|125.0||If the upper limit of the 90% confidence interval is \< 125.00%, no effect of safinamide on diclofenamic acid bioavailability is present (no interaction present).|ANOVA|||The PK parameters AUC0-t and Cmax were analysed using analysis of variance (ANOVA). Before analysis, the data were transformed using a neperian logarithmic transformation. ANOVA was performed taking into account treatment, period, sequence and subject (sequence) as fixed effects with a variance components structure of the covariance matrix.||125|80|0.1
72385972|NCT02495831|144279622|SUPERIORITY_OR_OTHER||geometric mean ratio|104.84|||||TWO_SIDED|90.0|96.4|114.02||||||||114.02|96.40|
72385973|NCT03789396|144279626|SUPERIORITY||Odds Ratio (OR)|0.74|STANDARD_ERROR_OF_MEAN|0.14||0.03|TWO_SIDED|95.0|0.57|0.97|||Regression, Logistic|||Comparison of patient odds of being hyperoxic and not on room air pre- versus post-intervention||0.97|0.57|0.03
72385974|NCT02281773|144279640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.2|STANDARD_ERROR_OF_MEAN|0.79||0.1256|TWO_SIDED|95.0|-2.76|0.34||Due to the exploratory nature of this trial, no multiplicity adjustment was made. All statistical testing was performed using a two-sided, α=0.05 level of significance.|Mixed Models Analysis|Unstructured covariance structure has been used to fit the mixed model. Kenward-Roger was used to model degrees of freedom.|Mean Difference (Final Values) is actually the Adjusted mean difference calculated as BI 409306 10 mg minus Placebo.|The restricted maximum likelihood (REML) based mixed effects model with repeated measurements (MMRM) was used with baseline value as fixed covariate and planned treatment, analysis visit, first test done, geographic region grouping 1, planned treatment by analysis visit and baseline value by analysis visit as fixed effects.||0.34|-2.76|0.1256
72385975|NCT02281773|144279640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3|STANDARD_ERROR_OF_MEAN|0.8||0.7337|TWO_SIDED|95.0|-1.3|1.84||Due to the exploratory nature of this trial, no multiplicity adjustment was made. All statistical testing was performed using a two-sided, α=0.05 level of significance.|Mixed Models Analysis|Unstructured covariance structure has been used to fit the mixed model. Kenward-Roger was used to model degrees of freedom.|Mean Difference (Final Values) is actually the Adjusted mean difference calculated as BI 409306 25 mg minus Placebo.|The restricted maximum likelihood (REML) based mixed effects model with repeated measurements (MMRM) was used with baseline value as fixed covariate and planned treatment, analysis visit, first test done, geographic region grouping 1, planned treatment by analysis visit and baseline value by analysis visit as fixed effects.||1.84|-1.30|0.7337
72385976|NCT02281773|144279640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3|STANDARD_ERROR_OF_MEAN|0.83||0.6994|TWO_SIDED|95.0|-1.31|1.95||Due to the exploratory nature of this trial, no multiplicity adjustment was made. All statistical testing was performed using a two-sided, α=0.05 level of significance.|Mixed Models Analysis|Unstructured covariance structure has been used to fit the mixed model. Kenward-Roger was used to model degrees of freedom.|Mean Difference (Final Values) is actually the Adjusted mean difference calculated as BI 409306 50 mg minus Placebo.|The restricted maximum likelihood (REML) based mixed effects model with repeated measurements (MMRM) was used with baseline value as fixed covariate and planned treatment, analysis visit, first test done, geographic region grouping 1, planned treatment by analysis visit and baseline value by analysis visit as fixed effects.||1.95|-1.31|0.6994
72385977|NCT02281773|144279640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.79||0.427|TWO_SIDED|95.0|-2.19|0.93||Due to the exploratory nature of this trial, no multiplicity adjustment was made. All statistical testing was performed using a two-sided, α=0.05 level of significance.|Mixed Models Analysis|Unstructured covariance structure has been used to fit the mixed model. Kenward-Roger was used to model degrees of freedom.|Mean Difference (Final Values) is actually the Adjusted mean difference calculated as BI 409306 100 mg minus Placebo.|The restricted maximum likelihood (REML) based mixed effects model with repeated measurements (MMRM) was used with baseline value as fixed covariate and planned treatment, analysis visit, first test done, geographic region grouping 1, planned treatment by analysis visit and baseline value by analysis visit as fixed effects.||0.93|-2.19|0.4270
72385978|NCT02281773|144279645|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3|STANDARD_ERROR_OF_MEAN|0.66||0.5972|TWO_SIDED|95.0|-0.9|1.6||Due to the exploratory nature of this trial, no multiplicity adjustment was made. All statistical testing was performed using a two-sided, α=0.05 level of significance.|ANCOVA||Mean Difference (Final Values) is actually the Adjusted mean difference calculated as BI 409306 10 mg minus Placebo.|Analyses of covariance (ANCOVA) were used to assess between-group differences (BI 409306 group minus placebo group) in the modelled changes from baseline to Week 12. The dependent variable was the change from the baseline score at Week 12 during the treatment period adjusted for fixed categorical covariates of treatment as well as fixed continuous covariates of baseline score.||1.6|-0.9|0.5972
72385979|NCT02281773|144279645|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.68||0.3817|TWO_SIDED|95.0|-1.9|0.7||Due to the exploratory nature of this trial, no multiplicity adjustment was made. All statistical testing was performed using a two-sided, α=0.05 level of significance.|ANCOVA||Mean Difference (Final Values) is actually the Adjusted mean difference calculated as BI 409306 25 mg minus Placebo.|Analyses of covariance (ANCOVA) were used to assess between-group differences (BI 409306 group minus placebo group) in the modelled changes from baseline to Week 12. The dependent variable was the change from the baseline score at Week 12 during the treatment period adjusted for fixed categorical covariates of treatment as well as fixed continuous covariates of baseline score.||0.7|-1.9|0.3817
72385980|NCT02281773|144279645|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.5|STANDARD_ERROR_OF_MEAN|0.68||0.48|TWO_SIDED|95.0|-0.9|1.8||Due to the exploratory nature of this trial, no multiplicity adjustment was made. All statistical testing was performed using a two-sided, α=0.05 level of significance.|ANCOVA||Mean Difference (Final Values) is actually the Adjusted mean difference calculated as BI 409306 50 mg minus Placebo.|Analyses of covariance (ANCOVA) were used to assess between-group differences (BI 409306 group minus placebo group) in the modelled changes from baseline to Week 12. The dependent variable was the change from the baseline score at Week 12 during the treatment period adjusted for fixed categorical covariates of treatment as well as fixed continuous covariates of baseline score.||1.8|-0.9|0.4800
72495333|NCT00915343|144519635|SUPERIORITY_OR_OTHER_LEGACY||Mean difference|-0.6||||0.3332|TWO_SIDED||||||Fisher's test|Fisher's non-parametric two-sample permutation test||Comparison of Quality of Life (QoL) Assessed by Short Form-36 Survey (SF-36) For Physical Component Score||||0.3332
72438528|NCT01424397|144390477|SUPERIORITY_OR_OTHER||Mean Difference (Net)|81.35|STANDARD_ERROR_OF_MEAN|12.56|||TWO_SIDED|90.0|60.54|102.15||||||Placebo versus FP 200 μg,Nasal Airflow resistance Total WM,0-4 hr||102.15|60.54|
72385981|NCT02281773|144279645|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|0.66||0.7507|TWO_SIDED|95.0|-1.1|1.5||Due to the exploratory nature of this trial, no multiplicity adjustment was made. All statistical testing was performed using a two-sided, α=0.05 level of significance.|ANCOVA||Mean Difference (Final Values) is actually the Adjusted mean difference calculated as BI 409306 100 mg minus Placebo.|Analyses of covariance (ANCOVA) were used to assess between-group differences (BI 409306 group minus placebo group) in the modelled changes from baseline to Week 12. The dependent variable was the change from the baseline score at Week 12 during the treatment period adjusted for fixed categorical covariates of treatment as well as fixed continuous covariates of baseline score.||1.5|-1.1|0.7507
72438529|NCT01424397|144390477|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-7.31|STANDARD_ERROR_OF_MEAN|19.548|||TWO_SIDED|90.0|-39.7|25.05||||||Placebo versus FP 12 mg SB-705498 , Nasal Airflow resistance Total WM, 0-4 hr||25.05|-39.7|
72438530|NCT01424397|144390477|SUPERIORITY_OR_OTHER||Mean Difference (Net)|72.4|STANDARD_ERROR_OF_MEAN|14.567|||TWO_SIDED|90.0|48.28|96.52||||||Placebo versus SB-705498 + FP 12 mg, Nasal Airflow resistance Total WM, 0-4 hr||96.52|48.28|
72438531|NCT01424397|144390477|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-8.95|STANDARD_ERROR_OF_MEAN|14.592|||TWO_SIDED|90.0|-33.1|15.22||||||FP 200 μg versus SB-705498 + FP 12 mg, Nasal Airflow resistance Total WM, 0-4 hr||15.22|-33.1|
72438532|NCT01424397|144390478|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.68|STANDARD_ERROR_OF_MEAN|0.113|||TWO_SIDED|90.0|-0.87|-0.49||||||||-0.49|-0.87|
72438533|NCT01424397|144390478|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.01|STANDARD_ERROR_OF_MEAN|0.173|||TWO_SIDED|90.0|-0.3|0.27||||||||0.27|-0.30|
72385982|NCT02281773|144279646|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.06||0.9399|TWO_SIDED|95.0|-0.1|0.1||Due to the exploratory nature of this trial, no multiplicity adjustment was made. All statistical testing was performed using a two-sided, α=0.05 level of significance.|ANCOVA||Mean Difference (Final Values) is actually the Adjusted mean difference calculated as BI 409306 10 mg minus Placebo.|Analyses of covariance (ANCOVA) were used to assess between-group differences (BI 409306 group minus placebo group) in the modelled changes from baseline to Week 12. The dependent variable was the change from the baseline score at Week 12 during the treatment period adjusted for fixed categorical covariates of treatment as well as fixed continuous covariates of baseline score.||0.1|-0.1|0.9399
72385983|NCT02281773|144279646|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.06||0.9919|TWO_SIDED|95.0|-0.1|0.1||Due to the exploratory nature of this trial, no multiplicity adjustment was made. All statistical testing was performed using a two-sided, α=0.05 level of significance.|ANCOVA||Mean Difference (Final Values) is actually the Adjusted mean difference calculated as BI 409306 25 mg minus Placebo.|Analyses of covariance (ANCOVA) were used to assess between-group differences (BI 409306 group minus placebo group) in the modelled changes from baseline to Week 12. The dependent variable was the change from the baseline score at Week 12 during the treatment period adjusted for fixed categorical covariates of treatment as well as fixed continuous covariates of baseline score.||0.1|-0.1|0.9919
72385984|NCT02281773|144279646|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.06||0.3027|TWO_SIDED|95.0|-0.1|0.2||Due to the exploratory nature of this trial, no multiplicity adjustment was made. All statistical testing was performed using a two-sided, α=0.05 level of significance.|ANCOVA||Mean Difference (Final Values) is actually the Adjusted mean difference calculated as BI 409306 50 mg minus Placebo.|Analyses of covariance (ANCOVA) were used to assess between-group differences (BI 409306 group minus placebo group) in the modelled changes from baseline to Week 12. The dependent variable was the change from the baseline score at Week 12 during the treatment period adjusted for fixed categorical covariates of treatment as well as fixed continuous covariates of baseline score.||0.2|-0.1|0.3027
72385985|NCT02281773|144279646|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.06||0.3901|TWO_SIDED|95.0|-0.1|0.2||Due to the exploratory nature of this trial, no multiplicity adjustment was made. All statistical testing was performed using a two-sided, α=0.05 level of significance.|ANCOVA||Mean Difference (Final Values) is actually the Adjusted mean difference calculated as BI 409306 100 mg minus Placebo.|Analyses of covariance (ANCOVA) were used to assess between-group differences (BI 409306 group minus placebo group) in the modelled changes from baseline to Week 12. The dependent variable was the change from the baseline score at Week 12 during the treatment period adjusted for fixed categorical covariates of treatment as well as fixed continuous covariates of baseline score.||0.2|-0.1|0.3901
72385986|NCT02899299|144279690|SUPERIORITY|Treatment A over Treatment B|Hazard Ratio (HR)|0.74||||0.002|TWO_SIDED|96.6|0.6|0.91||Boundary for statistical significance was a p-value \< 0.0345|Stratified Log Rank|This is 2 sided p-value from log-rank test stratified by histology and sex as entered in the IRT|Stratified Cox proportional hazard model|||0.91|0.60|0.0020
72438534|NCT01424397|144390478|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.52|STANDARD_ERROR_OF_MEAN|0.13|||TWO_SIDED|90.0|-0.74|-0.31||||||||-0.31|-0.74|
72438535|NCT01424397|144390478|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.15|STANDARD_ERROR_OF_MEAN|0.13|||TWO_SIDED|90.0|-0.06|0.37||||||||0.37|-0.06|
72438536|NCT01444417|144390486|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|9.0497||||0.0018|TWO_SIDED|95.0|1.896|43.199|||Cochran-Mantel-Haenszel|P-value from Cochran-Mantel-Haenszel test stratified by baseline age group.||The incidence of durable platelet response was compared by the Cochran-Mantel-Haenszel test stratified by the baseline age group. The Mantel-Haenszel common odds ratio (romiplostim vs placebo) was estimated along with its 95% confidence interval.||43.199|1.896|0.0018
72438537|NCT01444417|144390487|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|9.0443||||0.0002|TWO_SIDED|95.0|2.535|32.265|||Cochran-Mantel-Haenszel|P-value from Cochran-Mantel-Haenszel test stratified by baseline age group.||The incidence of overall platelet response was compared by the Cochran-Mantel-Haenszel test stratified by the baseline age group. The Mantel-Haenszel common odds ratio (romiplostim vs placebo) was estimated along with its 95% confidence interval.||32.265|2.535|0.0002
72438538|NCT01444417|144390488|SUPERIORITY_OR_OTHER|||||||0.0004|||||||ANOVA|P-value from Analysis of Variance with main effects (treatment and age group) model after testing for non-significant interaction (p-value ≥ 0.10).||||||0.0004
72438539|NCT01444417|144390489|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.813||||0.7103|TWO_SIDED|95.0|0.277|2.391|||Cochran-Mantel-Haenszel|P-value from Cochran-Mantel-Haenszel test stratified by baseline age group||||2.391|0.277|0.7103
72558750|NCT02034513|144647481|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was considered confirmed if the upper bound of the two-sided 95% confidence interval was below or equal to 0.40%. Comparison groups: IDeg versus IGlar. Number of subjects included in analysis is 437 (n=220 for IDeg and n=217 for IGlar).|Treatment contrast|0.03|||||TWO_SIDED|95.0|-0.1|0.15||||||"Change from baseline in HbA1c at week 32 (treatment period 1). Before testing the primary endpoint, the secondary supportive efficacy endpoint Change from baseline in HbA1c after 32 weeks of treatment was tested for non-inferiority as a prerequisite for testing the primary endpoint. Analysis was based on mixed model for repeated measurement (MMRM); treatment, sex, region, pre-trial insulin treatment regimen, visit and dosing time were fixed effects, and age and baseline HbA1c were covariates."||0.15|-0.10|
72438540|NCT01214824|144390498|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.3||||0.014||95.0|||||Wilcoxon signed rank test|||Comparison is HbA1c at 6 months versus Baseline||||0.014
72618880|NCT01260324|144768302|SUPERIORITY_OR_OTHER_LEGACY||Incidence rate per 1000 person-years|0.04|||||TWO_SIDED|95.0|0.04|0.05|||||Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.|Incidence rate Female||0.05|0.04|
72385987|NCT02899299|144279693|SUPERIORITY|Treatment A over Treatment B|Hazard Ratio (HR)|0.93|||||TWO_SIDED|95.0|0.77|1.13|||||Stratified Cox proportional hazard model|||1.13|0.77|
72385988|NCT02899299|144279694|SUPERIORITY|Treatment A vs Treatment B|Hazard Ratio (HR)|0.92|||||TWO_SIDED|95.0|0.64|1.32||||||\<1% PD-L1||1.32|0.64|
72385989|NCT02899299|144279694|SUPERIORITY|Treatment A vs Treatment B|Hazard Ratio (HR)|0.72|||||TWO_SIDED|95.0|0.59|0.88||||||≥1% PD-L1||0.88|0.59|
72385990|NCT02899299|144279695|SUPERIORITY|Treatment A vs Treatment B|Hazard Ratio (HR)|1.79|||||TWO_SIDED|95.0|1.22|2.63||||||\< 1% PD-L1||2.63|1.22|
72385991|NCT02899299|144279695|SUPERIORITY|Treatment A vs Treatment B|Hazard Ratio (HR)|0.77|||||TWO_SIDED|95.0|0.61|0.96||||||≥1% PD-L1||0.96|0.61|
72385992|NCT02899299|144279697|SUPERIORITY|Treatment A over Treatment B|Hazard Ratio (HR)|0.74||||0.0008|TWO_SIDED|95.0|0.62|0.88|||Stratified Log Rank|This is 2 sided p-value from log-rank test stratified by histology and sex as entered in the IRT|Stratified Cox proportional hazard model|||0.88|0.62|0.0008
72385993|NCT00313300|144279700|SUPERIORITY_OR_OTHER||Adjusted rate difference|2.2|||||TWO_SIDED|95.0|-1.0|5.4|||||adjusted difference of event rates takes into consideration stratification factors.|||5.4|-1.0|
72385994|NCT00313300|144279700|SUPERIORITY_OR_OTHER||Adjusted Rate Difference|3.8|||||TWO_SIDED|95.0|0.4|7.3|||||adjusted difference of event rates takes into consideration stratification factors.|||7.3|0.4|
72385995|NCT00313300|144279701|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.73|||||TWO_SIDED|95.0|0.44|1.19||||||||1.19|0.44|
72385996|NCT00313300|144279701|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.61|||||TWO_SIDED|95.0|0.35|1.04||||||||1.04|0.35|
72385997|NCT00313300|144279702|SUPERIORITY_OR_OTHER||Adjusted rate difference|6.6|||||TWO_SIDED|95.0|1.8|11.3|||||adjusted difference of event rates takes into consideration stratification factors.|||11.3|1.8|
72385998|NCT00313300|144279702|SUPERIORITY_OR_OTHER||Adjusted Rate Difference|10.0|||||TWO_SIDED|95.0|4.8|15.2|||||adjusted difference of event rates takes into consideration stratification factors.|||15.2|4.8|
72385999|NCT00313300|144279703|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.71|||||TWO_SIDED|95.0|0.44|1.17||||||||1.17|0.44|
72386000|NCT00313300|144279703|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.63|||||TWO_SIDED|95.0|0.37|1.07||||||||1.07|0.37|
72386001|NCT00313300|144279704|SUPERIORITY_OR_OTHER||Adjusted rate difference|0.3|||||TWO_SIDED|95.0|-1.3|2.0|||||adjusted difference of event rates takes into consideration stratification factors.|||2.0|-1.3|
72386002|NCT00313300|144279704|SUPERIORITY_OR_OTHER||Adjusted Rate Difference|0.8|||||TWO_SIDED|95.0|-1.1|2.7|||||adjusted difference of event rates takes into consideration stratification factors.|||2.7|-1.1|
72386003|NCT00313300|144279705|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.13|||||TWO_SIDED|95.0|0.44|2.88||||||||2.88|0.44|
72386004|NCT00313300|144279705|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.86|||||TWO_SIDED|95.0|0.29|2.57||||||||2.57|0.29|
72386005|NCT00313300|144279705|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.71|||||TWO_SIDED|95.0|0.3|1.66||||||||1.66|0.30|
72386006|NCT00313300|144279705|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.72|||||TWO_SIDED|95.0|0.3|1.74||||||||1.74|0.30|
72386007|NCT00313300|144279706|SUPERIORITY_OR_OTHER||Adjusted Rate Difference|4.0|||||TWO_SIDED|95.0|0.0|8.1||||||||8.1|0.0|
72386008|NCT00313300|144279706|SUPERIORITY_OR_OTHER||Adjusted Rate Difference|4.7|||||TWO_SIDED|95.0|0.0|9.3||||||||9.3|0.0|
72386009|NCT00313300|144279706|SUPERIORITY_OR_OTHER||Adjusted Rate Difference|7.0|||||TWO_SIDED|95.0|3.4|10.5||||||||10.5|3.4|
72386010|NCT00313300|144279706|SUPERIORITY_OR_OTHER||Adjusted Rate Difference|4.7|||||TWO_SIDED|95.0|1.4|8.0||||||||8.0|1.4|
72618881|NCT01260324|144768302|SUPERIORITY_OR_OTHER_LEGACY||Incidence rate per 1000 person-years|0.05|||||TWO_SIDED|95.0|0.05|0.06|||||Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.|Incidence rate Male||0.06|0.05|
72386011|NCT00313300|144279707|SUPERIORITY_OR_OTHER||Adjusted Rate Difference|8.3|||||TWO_SIDED|95.0|1.8|14.9||||||||14.9|1.8|
72386012|NCT00313300|144279707|SUPERIORITY_OR_OTHER||Adjusted Rate Difference|10.9|||||TWO_SIDED|95.0|3.4|18.4||||||||18.4|3.4|
72386013|NCT00313300|144279707|SUPERIORITY_OR_OTHER||Adjusted Rate Difference|17.4|||||TWO_SIDED|95.0|11.6|23.2||||||||23.2|11.6|
72386014|NCT00313300|144279707|SUPERIORITY_OR_OTHER||Adjusted Rate Difference|10.4|||||TWO_SIDED|95.0|5.6|15.1||||||||15.1|5.6|
72386015|NCT00313300|144279708|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.13|||||TWO_SIDED|95.0|0.44|2.88||||||||2.88|0.44|
72386016|NCT00313300|144279708|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.86|||||TWO_SIDED|95.0|0.29|2.57||||||||2.57|0.29|
72386017|NCT00313300|144279708|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.71|||||TWO_SIDED|95.0|0.3|1.66||||||||1.66|0.30|
72386018|NCT00313300|144279708|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.72|||||TWO_SIDED|95.0|0.3|1.74||||||||1.74|0.30|
72386019|NCT00313300|144279709|SUPERIORITY_OR_OTHER||Adjusted Rate Difference|0.8|||||TWO_SIDED|95.0|-0.9|2.6||||||||2.6|-0.9|
72386020|NCT00313300|144279709|SUPERIORITY_OR_OTHER||Adjusted Rate Difference|2.9|||||TWO_SIDED|95.0|0.6|5.1||||||||5.1|0.6|
72438541|NCT01214824|144390500|SUPERIORITY_OR_OTHER|||||||0.5304||95.0|||||Paired t-test|||Comparison is masked phase 2 versus masked phase 1||||0.5304
72438542|NCT03475316|144390502|SUPERIORITY||Mean Difference (Final Values)|0.17|STANDARD_ERROR_OF_MEAN|0.57|||TWO_SIDED|95.0|-1.14|1.49|||||The estimate parameter is the difference in change at post intervention from pre between dance and treadmill group.|Linear mixed effects model were used to compare changes in the composite score pre and post intervention.||1.49|-1.14|
72558751|NCT02034513|144647481|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was considered confirmed if the upper bound of the two-sided 95% confidence interval was below or equal to 0.40%. Comparison groups: IDeg versus IGlar. Number of subjects included in analysis is 410 (n=202 for IDeg and n=208 for IGlar).|Treatment contrast|0.11|||||TWO_SIDED|95.0|0.0|0.23||||||"Change from baseline in HbA1c at week 64 (treatment period 2). The baseline values are week 32 values. Before the primary endpoint was tested, the secondary supportive efficacy endpoint Change from baseline in HbA1c after 32 weeks of treatment was tested for non-inferiority as prerequisite for testing the primary endpoint. Analysis was based on MMRM; treatment, sex, region, pre-trial insulin treatment regimen, visit and dosing time were fixed effects, and age and baseline HbA1c were covariates"||0.23|-0.00|
72558752|NCT02218541|144647490|OTHER|||||||1||||||threshold for significance will be p-value \<0.05|Fisher Exact|||||||1.00
72558753|NCT02218541|144647491|OTHER|||||||0.039||||||This statistical analysis applies to Yes bleeding|Binomial|The statistical analysis was changed during the analysis phase but the protocol was not amended to reflect this change||||||0.039
72438543|NCT03475316|144390503|SUPERIORITY||Mean Difference (Net)|166.16|STANDARD_ERROR_OF_MEAN|-202.7|||TWO_SIDED|95.0|-231.12|563.44|||||The estimate parameter reflects change in functional activation/deactivation pattern from pre to post intervention as a function intervention (social dancing vs. treadmill walking).|Estimates with standard errors (SE) are from linear mixed effect models used to examine the difference in change in functional activation/deactivation covariance patterns during the Digit Symbol Substitution test at post intervention from pre intervention between the social dancing and treadmill walking group.||563.44|-231.12|
72386021|NCT00313300|144279709|SUPERIORITY_OR_OTHER||Adjusted Rate Difference|4.1|||||TWO_SIDED|95.0|1.3|6.9||||||||6.9|1.3|
72386022|NCT01935791|144279733|OTHER||||||<|0.01||||||The p-values were adjusted for multiple comparisons. The a priori threshold for statistical significance is p\<0.05.|ANOVA|plus Tukey test||||||<0.01
72386023|NCT01935791|144279734|OTHER||||||<|0.001|||||||ANOVA|plus Tukey test||||||<0.001
72386024|NCT02468232|144279742|SUPERIORITY||Hazard Ratio (HR)|1.0881||||0.626|TWO_SIDED|95.0|0.6501|1.8212|||Regression, Cox|||For Primary Composite||1.8212|0.6501|0.6260
72386025|NCT02468232|144279742|SUPERIORITY||Hazard Ratio (HR)|1.1701||||0.6493|TWO_SIDED|95.0|0.5242|2.6122|||Regression, Cox|||For CV Death||2.6122|0.5242|0.6493
72386026|NCT02468232|144279742|SUPERIORITY||Hazard Ratio (HR)|1.2673||||0.7851|TWO_SIDED|95.0|0.7039|2.2818|||Regression, Cox|||For 1st HF Hospitalization||2.2818|0.7039|0.7851
72386027|NCT02468232|144279743|SUPERIORITY||LSM of ratio|0.8657||||0.0326|TWO_SIDED|95.0|0.7585|0.988||Indicates statistical significance (2-sided) with an alpha level of 0.05|ANCOVA|Repeated measure ANCOVA model||Week 4 analysis||0.9880|0.7585|0.0326
72386028|NCT02468232|144279743|SUPERIORITY||LSM of ratio|0.8538||||0.0161|TWO_SIDED|95.0|0.7509|0.9708||Indicates statistical significance (2-sided) with an alpha level of 0.05|ANCOVA|Repeated measure ANCOVA model||Week 8 analysis||0.9708|0.7509|0.0161
72386029|NCT02468232|144279743|SUPERIORITY||LSM of ratio|0.8112||||0.0104|TWO_SIDED|95.0|0.6916|0.9514||Indicates statistical significance (2-sided) with an alpha level of 0.05|ANCOVA|Repeated measure of ANCOVA model||Month 6 analysis||0.9514|0.6916|0.0104
72386030|NCT02468232|144279745|SUPERIORITY||Hazard Ratio (HR)|1.024||||0.5406|TWO_SIDED|95.0|0.6492|1.6152|||Regression, Cox|||First triple composite endpoint||1.6152|0.6492|0.5406
72386031|NCT02468232|144279745|SUPERIORITY||Hazard Ratio (HR)|1.1701||||0.6493|TWO_SIDED|95.0|0.5242|2.6122|||Regression, Cox|||CV health||2.6122|0.5242|0.6493
72386032|NCT02468232|144279745|SUPERIORITY||Hazard Ratio (HR)|0.8546||||0.3448|TWO_SIDED|95.0|0.3952|1.8479|||Regression, Cox|||First worsening of HF in outpatient||1.8479|0.3952|0.3448
72386033|NCT02468232|144279746|SUPERIORITY|||||||0.7115|||||||Cochran-Mantel-Haenszel|based on modified ridit scores||Week 4 analysis||||0.7115
72386034|NCT02468232|144279746|SUPERIORITY|||||||0.1752|||||||Cochran-Mantel-Haenszel|based on modified ridit scores||Week 8 analysis||||0.1752
72386035|NCT02468232|144279746|SUPERIORITY|||||||0.2688|||||||Cochran-Mantel-Haenszel|based on modified ridit scores||Month 6 analysis||||0.2688
72438544|NCT03475316|144390503|SUPERIORITY||Mean Difference (Net)|24.6|STANDARD_ERROR_OF_MEAN|28.47|||TWO_SIDED|95.0|-31.2|80.4|||||The estimate parameter reflects change in functional activation/deactivation pattern from pre to post intervention as a function intervention (social dancing vs. treadmill walking).|Estimates with standard errors (SE) and p-values are from linear mixed effect models used to examine the difference in change in functional activation/deactivation covariance patterns during the Flanker interference test at post intervention from pre intervention between the social dancing and treadmill walking group.||80.40|-31.20|
72438545|NCT03475316|144390503|SUPERIORITY||Mean Difference (Net)|58.22|STANDARD_ERROR_OF_MEAN|51.2|||TWO_SIDED|95.0|-42.14|158.58|||||The estimate parameter reflects change in functional activation/deactivation pattern from pre to post intervention as a function intervention (social dancing vs. treadmill walking).|Estimates with standard errors (SE) are from linear mixed effect models used to examine the difference in functional activation/deactivation covariance patterns during the Imagery of Walking-While Talking task at post intervention from pre intervention between the social dancing and treadmill walking group.||158.58|-42.14|
72438546|NCT03475316|144390504|SUPERIORITY||Mean Difference (Final Values)|0.77|STANDARD_ERROR_OF_MEAN|2.7|||TWO_SIDED|95.0|-5.1|6.64|||||The Estimation Parameter is the difference in change at post from pre between dance and treadmill group.|Linear mixed effects model were used to compare changes in the CHAMPS scores pre and post intervention.||6.64|-5.10|
72438547|NCT03475316|144390505|SUPERIORITY||Mean Difference (Final Values)|7.27|STANDARD_ERROR_OF_MEAN|8.57|||TWO_SIDED|95.0|-11.6|26.14|||||The estimate parameter is the difference in change at post intervention from pre between dance and treadmill group.|Linear mixed effects model were used to compare changes in gait speed pre and post intervention.||26.14|-11.60|
72438548|NCT03475316|144390506|SUPERIORITY||Mean Difference (Final Values)|0.57|STANDARD_ERROR_OF_MEAN|5.91|||TWO_SIDED|95.0|-13.4|14.55|||||The estimate parameter is the difference in change at post intervention from pre between dance and treadmill group.|Linear mixed effects model were used to compare changes in unipedal stance time pre and post intervention.||14.55|-13.40|
72438549|NCT03475316|144390508|SUPERIORITY||Mean Difference (Final Values)|1.08|STANDARD_ERROR_OF_MEAN|1.11|||TWO_SIDED|95.0|-1.3|3.46|||||The estimate parameter is the difference in change at post intervention from pre between dance and treadmill group.|Linear mixed effects model were used to compare changes in the geriatric depression scale pre and post intervention.||3.46|-1.30|
72386036|NCT02468232|144279747|SUPERIORITY||LSM of difference|2.5455||||0.1854|TWO_SIDED|95.0|-1.2306|6.3216|||ANCOVA|Repeated measure ANCOVA model||Week 8 analysis||6.3216|-1.2306|0.1854
72386037|NCT02468232|144279747|SUPERIORITY||LSM of difference|1.2695||||0.5737|TWO_SIDED|95.0|-3.1715|5.7104|||ANCOVA|Repeated measure ANCOVA model||Month 6 analysis||5.7104|-3.1715|0.5737
72386038|NCT02468232|144279748|SUPERIORITY||rate ratio|0.8699||||0.6501||95.0|0.4763|1.5887|||Negative binomial (NB) regression model|adjusted for treatment and stratification of screening NT-proBNP||||1.5887|0.4763|0.6501
72386039|NCT02468232|144279749|SUPERIORITY|||||||0.6211|||||||Cochran-Mantel-Haenszel|||||||0.6211
72386040|NCT02468232|144279751|SUPERIORITY||Hazard Ratio (HR)|1.1895||||0.6955|TWO_SIDED|95.0|0.6116|2.3134|||Regression, Cox|||||2.3134|0.6116|0.6955
72386041|NCT02468232|144279753|SUPERIORITY||Rate ratio|1.0192||||0.9233|TWO_SIDED|95.0|0.6925|1.4999|||Negative binomial (NB) regression model|adjusted for treatment and stratification of screening NT-proBNP||||1.4999|0.6925|0.9233
72386042|NCT02468232|144279754|SUPERIORITY||Rate ratio|1.0754||||0.9272|TWO_SIDED|95.0|0.2264|5.1067|||Negative binomial (NB) regression model|adjusted for treatment and stratification of screening NT-proBNP||||5.1067|0.2264|0.9272
72386043|NCT02468232|144279756|SUPERIORITY||Rate ratio|0.4504||||0.0697|TWO_SIDED|95.0|0.1902|1.0665||Negative binomial (NB) regression model|Negative binomial (NB) regression model|adjusted for treatment and stratification of screening NT-proBNP||||1.0665|0.1902|0.0697
72386044|NCT00617851|144279792|NON_INFERIORITY_OR_EQUIVALENCE|The GMTs and 95% CIs and median, min and max values were calculated for each vaccine group and for each strain by exponentiating (base 10) the least square means of the log transformed (base 10) titers and their 95% CIs obtained from a two-way ANOVA with factors for vaccine group. The overall power is 80.56%, and thus each single test (# of comparisons=9) is performed with a power of 97.62% assuming independency. To account for dropouts, \>= 428 subjects per lot was recruited.|Ratio of GMTs (A/H1N1 Strain)|1.09|||||TWO_SIDED|95.0|0.92|1.29|||ANOVA||"The control vaccine arm (Comparator, n=216) is included primarily to provide a comparative assessment for safety rather than for immunogenicity.~Sample size calculations were done by means of Nquery Advisor 5.0."|H01 LotA ≠ LotB versus H1 LotA = LotB H0 refers to the null hypothesis of non-equivalence (inconsistency) in that the two-sided 95% confidence interval (CI) on the geometric mean titer (GMT) ratio is outside the equivalence range (0.67 to 1.5). H1 refers to the alternative hypothesis of equivalence (consistency) in that the two-sided 95% CI on the GMT ratio is within the equivalence range (0.67 to 1.5).||1.29|0.92|
72386045|NCT00617851|144279792|NON_INFERIORITY_OR_EQUIVALENCE|The GMTs and 95% CIs and median, min and max values were calculated for each vaccine group and for each strain by exponentiating (base 10) the least square means of the log transformed (base 10) titers and their 95% CIs obtained from a two-way ANOVA with factors for vaccine group. The overall power is 80.56%, and thus each single test (# of comparisons=9) is performed with a power of 97.62% assuming independency. To account for dropouts, \>= 428 subjects per lot was recruited.|Ratio of GMTs (A/H1N1 Strain)|1.1|||||TWO_SIDED|95.0|0.93|1.31|||ANOVA||"The control vaccine arm (Comparator, n=216) is included primarily to provide a comparative assessment for safety rather than for immunogenicity.~Sample size calculations were done by means of Nquery Advisor 5.0."|H02 LotA ≠ LotC versus H12 LotA = Lotc H0 refers to the null hypothesis of non-equivalence (inconsistency) in that the two-sided 95% CI on the GMT ratio is outside the equivalence range (0.67 to 1.5). H1 refers to the alternative hypothesis of equivalence (consistency) in that the two-sided 95% CI on the GMT ratio is within the equivalence range (0.67 to 1.5).||1.31|0.93|
72386046|NCT00617851|144279792|NON_INFERIORITY_OR_EQUIVALENCE|The GMTs and 95% CIs and median, min and max values were calculated for each vaccine group and for each strain by exponentiating (base 10) the least square means of the log transformed (base 10) titers and their 95% CIs obtained from a two-way ANOVA with factors for vaccine group. The overall power is 80.56%, and thus each single test (# of comparisons=9) is performed with a power of 97.62% assuming independency. To account for dropouts, \>= 428 subjects per lot was recruited.|Ratio of GMTs (A/H1N1 Strain)|1.01|||||TWO_SIDED|95.0|0.85|1.2|||ANOVA||"The control vaccine arm (Comparator, n=216) is included primarily to provide a comparative assessment for safety rather than for immunogenicity.~Sample size calculations were done by means of Nquery Advisor 5.0."|H03 LotB ≠ LotC versus H13 LotB = LotC H0 refers to the null hypothesis of non-equivalence (inconsistency) in that the two-sided 95% CI on the GMT ratio is outside the equivalence range (0.67 to 1.5). H1 refers to the alternative hypothesis of equivalence (consistency) in that the two-sided 95% CI on the GMT ratio is within the equivalence range (0.67 to 1.5).||1.2|0.85|
72386047|NCT00617851|144279792|NON_INFERIORITY_OR_EQUIVALENCE|The GMTs and 95% CIs and median, min and max values were calculated for each vaccine group and for each strain by exponentiating (base 10) the least square means of the log transformed (base 10) titers and their 95% CIs obtained from a two-way ANOVA with factors for vaccine group. The overall power is 80.56%, and thus each single test (# of comparisons=9) is performed with a power of 97.62% assuming independency. To account for dropouts, \>= 428 subjects per lot was recruited.|Ratio of GMTs (A/H3N2 Strain)|1.12|||||TWO_SIDED|95.0|0.97|1.3|||ANOVA||"The control vaccine arm (Comparator, n=216) is included primarily to provide a comparative assessment for safety rather than for immunogenicity.~Sample size calculations were done by means of Nquery Advisor 5.0."|H03 LotA ≠ LotB versus H13 LotA = LotB H0 refers to the null hypothesis of non-equivalence (inconsistency) in that the two-sided 95% CI on the GMT ratio is outside the equivalence range (0.67 to 1.5). H1 refers to the alternative hypothesis of equivalence (consistency) in that the two-sided 95% CI on the GMT ratio is within the equivalence range (0.67 to 1.5).||1.3|0.97|
72558754|NCT02218541|144647492|EQUIVALENCE|No power calculation was done as this was a pilot study.||||||1||||||This statistical analysis applies to Yes Provisional Crown fit|Binomial|The statistical analysis was changed during the analysis phase but the protocol was not amended to reflect this change||||||1.0
72395144|NCT02730455|144296814|SUPERIORITY||Adjusted Mean Difference|1.2||||0.315|TWO_SIDED|95.0|-1.1|3.4|||Mixed-effects model for repeated measure|||Treatment and treatment by visit interaction were included in the model as explanatory variables. Baseline NIHSS category (score 5-15, 16-23), tPA use (yes/no), age (\<60, 60-69, 70-80), thrombectomy (yes/no), region (Spain, UK/Germany, USA) and treatment window were considered as covariates. An unstructured variance-covariance matrix was used in the model.||3.40|-1.10|0.315
72495334|NCT00915343|144519635|SUPERIORITY_OR_OTHER_LEGACY||Mean difference|0.9||||0.3405|TWO_SIDED||||||Fisher's test|Fisher's non-parametric two-sample permutation test||Comparison of Quality of Life (QoL) Assessed by Short Form-36 Survey (SF-36) For Mental Component Score||||0.3405
72495335|NCT00915343|144519636|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8418|TWO_SIDED||||||Wilcoxon Signed Rank|||Change From Baseline to 6 months in Quality of Life (QoL) Assessed by Short Form-36 Survey (SF-36) For Physical Component Score||||0.8418
72558755|NCT00385736|144647493|SUPERIORITY_OR_OTHER|||||||0.031||95.0||||The primary endpoint analysis was carried out in hierarchical order (as presented) to handle the multiplicity issues induced by the two adalimumab groups being compared to placebo and to control the overall alpha level of 0.05.|Chi-squared|||||||0.031
72386048|NCT00617851|144279792|NON_INFERIORITY_OR_EQUIVALENCE|The GMTs and 95% CIs and median, min and max values were calculated for each vaccine group and for each strain by exponentiating (base 10) the least square means of the log transformed (base 10) titers and their 95% CIs obtained from a two-way ANOVA with factors for vaccine group. The overall power is 80.56%, and thus each single test (# of comparisons=9) is performed with a power of 97.62% assuming independency. To account for dropouts, \>= 428 subjects per lot was recruited.|Ratio of GMTs (A/H3N2 strain)|0.98|||||TWO_SIDED|95.0|0.85|1.13|||ANOVA||"The control vaccine arm (Comparator, n=216) is included primarily to provide a comparative assessment for safety rather than for immunogenicity.~Sample size calculations were done by means of Nquery Advisor 5.0."|H03 LotA ≠ LotC versus H13 LotA = LotC H0 refers to the null hypothesis of non-equivalence (inconsistency) in that the two-sided 95% CI on the GMT ratio is outside the equivalence range (0.67 to 1.5). H1 refers to the alternative hypothesis of equivalence (consistency) in that the two-sided 95% CI on the GMT ratio is within the equivalence range (0.67 to 1.5).||1.13|0.85|
72618882|NCT01260324|144768302|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.83|||||TWO_SIDED|95.0|1.5|2.22|||||Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.|Odds ratio Male||2.22|1.50|
72386049|NCT00617851|144279792|NON_INFERIORITY_OR_EQUIVALENCE|The GMTs and 95% CIs and median, min and max values were calculated for each vaccine group and for each strain by exponentiating (base 10) the least square means of the log transformed (base 10) titers and their 95% CIs obtained from a two-way ANOVA with factors for vaccine group. The overall power is 80.56%, and thus each single test (# of comparisons=9) is performed with a power of 97.62% assuming independency. To account for dropouts, \>= 428 subjects per lot was recruited.|Ratio of GMTs (A/H3N2 strain)|0.87|||||TWO_SIDED|95.0|0.76|1.01|||ANOVA||"The control vaccine arm (Comparator, n=216) is included primarily to provide a comparative assessment for safety rather than for immunogenicity.~Sample size calculations were done by means of Nquery Advisor 5.0."|H03 LotB ≠ LotC versus H13 LotB = LotC H0 refers to the null hypothesis of non-equivalence (inconsistency) in that the two-sided 95% CI on the GMT ratio is outside the equivalence range (0.67 to 1.5). H1 refers to the alternative hypothesis of equivalence (consistency) in that the two-sided 95% CI on the GMT ratio is within the equivalence range (0.67 to 1.5).||1.01|0.76|
72386050|NCT00617851|144279792|NON_INFERIORITY_OR_EQUIVALENCE|The GMTs and 95% CIs and median, min and max values were calculated for each vaccine group and for each strain by exponentiating (base 10) the least square means of the log transformed (base 10) titers and their 95% CIs obtained from a two-way ANOVA with factors for vaccine group. The overall power is 80.56%, and thus each single test (# of comparisons=9) is performed with a power of 97.62% assuming independency. To account for dropouts, \>= 428 subjects per lot was recruited.|Ratio of GMTs (B strain)|1.06|||||TWO_SIDED|95.0|0.91|1.23|||ANOVA||"The control vaccine arm (Comparator, n=216) is included primarily to provide a comparative assessment for safety rather than for immunogenicity.~Sample size calculations were done by means of Nquery Advisor 5.0."|H03 LotA ≠ LotB versus H13 LotA = LotB H0 refers to the null hypothesis of non-equivalence (inconsistency) in that the two-sided 95% CI on the GMT ratio is outside the equivalence range (0.67 to 1.5). H1 refers to the alternative hypothesis of equivalence (consistency) in that the two-sided 95% CI on the GMT ratio is within the equivalence range (0.67 to 1.5).||1.23|0.91|
72386051|NCT00617851|144279792|NON_INFERIORITY_OR_EQUIVALENCE|The GMTs and 95% CIs and median, min and max values were calculated for each vaccine group and for each strain by exponentiating (base 10) the least square means of the log transformed (base 10) titers and their 95% CIs obtained from a two-way ANOVA with factors for vaccine group. The overall power is 80.56%, and thus each single test (# of comparisons=9) is performed with a power of 97.62% assuming independency. To account for dropouts, \>= 428 subjects per lot was recruited.|Ratio of GMTs (B strain)|1.15|||||TWO_SIDED|95.0|0.99|1.33|||ANOVA||"The control vaccine arm (Comparator, n=216) is included primarily to provide a comparative assessment for safety rather than for immunogenicity.~Sample size calculations were done by means of Nquery Advisor 5.0."|H03 LotA ≠ LotC versus H13 LotA = LotC H0 refers to the null hypothesis of non-equivalence (inconsistency) in that the two-sided 95% CI on the GMT ratio is outside the equivalence range (0.67 to 1.5). H1 refers to the alternative hypothesis of equivalence (consistency) in that the two-sided 95% CI on the GMT ratio is within the equivalence range (0.67 to 1.5).||1.33|0.99|
72386052|NCT00617851|144279792|NON_INFERIORITY_OR_EQUIVALENCE|The GMTs and 95% CIs and median, min and max values were calculated for each vaccine group and for each strain by exponentiating (base 10) the least square means of the log transformed (base 10) titers and their 95% CIs obtained from a two-way ANOVA with factors for vaccine group. The overall power is 80.56%, and thus each single test (# of comparisons=9) is performed with a power of 97.62% assuming independency. To account for dropouts, \>= 428 subjects per lot was recruited.|Ratio of GMTs (B strain)|1.09|||||TWO_SIDED|95.0|0.94|1.26|||ANOVA||"The control vaccine arm (n=216) is included primarily to provide a comparative assessment for safety rather than for immunogenicity.~Sample size calculations were done by means of Nquery Advisor 5.0."|H03 LotB ≠ LotC versus H13 LotB = LotC H0 refers to the null hypothesis of non-equivalence (inconsistency) in that the two-sided 95% CI on the GMT ratio is outside the equivalence range (0.67 to 1.5). H1 refers to the alternative hypothesis of equivalence (consistency) in that the two-sided 95% CI on the GMT ratio is within the equivalence range (0.67 to 1.5).||1.26|0.94|
72386053|NCT02476201|144279831|SUPERIORITY|Using a one-sided, one sample Exact Binomial Test and a significance level of 2.5%, the study required 74 patients to reach a power of 90%. With the MPP feature activated at baseline, it was assumed that the proportion of responders at 6 months was 75%. The MPP responder rate was compared to 57%, which is the responder rate obtained from literature for patients without the MPP feature activated.|Percentage|67.1||||0.0435|ONE_SIDED|97.5|55.6||||Exact binomial||||||55.6|0.0435
72495336|NCT00915343|144519636|SUPERIORITY_OR_OTHER_LEGACY|||||||0.355|TWO_SIDED||||||Wilcoxon Signed Rank test|||Change From Baseline to 6 months in Quality of Life (QoL) Assessed by Short Form-36 Survey (SF-36) For Mental Component Score||||0.3550
72495337|NCT00915343|144519637|SUPERIORITY_OR_OTHER_LEGACY||Mean difference|-2.9||||0.0823|TWO_SIDED||||||Fisher's|Fisher's non-parametric two-sample permutation test||||||0.0823
72438550|NCT00468052|144390517|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED|||||Null hypothesis is not significantly different from group D and F.|Wilcoxon (Mann-Whitney)|||Sixty subjects were required per group to determine that with Dex would decrease the incidence of severe EA after surgery by 50% with 80% power (0.05)in comparison with the control group.60 subjects were required by group to show the that intraoperative rescue fentanyl and rescue morphine in the PACU would be 50% lower in subjects receiving dex.||||.001
72386054|NCT00398918|144279841|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.2|STANDARD_ERROR_OF_MEAN|3.4|<|0.05||95.0|||||Mixed Models Analysis|Results presented are for post-hoc comparisons of least squares means with Tukey-Kramer adjucted p values.|The estimated value is for the difference between the means obtained for the second hour of the self-administration sessions for the placebo and zonisamide conditions.|The analysis involved a within subjects comparison. The null hypothesis was that there would be no difference in the amount of ethanol consumed in either the first or second hour of self-administration sessions. Results presented here are for the second hour of the self-administration sessions.||||<0.05
72386055|NCT00398918|144279842|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.2|STANDARD_ERROR_OF_MEAN|5.7||0.61||95.0||||P value shown is for a post-hoc comparison of least squares means generated by the mixed model used.|Mixed Models Analysis||Analysis for difference between DSMT scores at 40 minutes post alcohol ingestion for zonisamide and placebo involved post-hoc comparisons of least squares means.|Null hypothesis: No difference in DSMT scores for zonisamide and placebo treatments 40 minutes after ingestion of ethanol.||||0.61
72386056|NCT04289623|144279883|SUPERIORITY||Odds Ratio (OR)|1.19||||0.007|TWO_SIDED|95.0|1.05|1.35||We used an a priori threshold of p \< .05.|Regression, Logistic|||We conducted a logistic regression among the previously enrolled group with the standard email as the reference group.||1.35|1.05|.007
72386057|NCT04289623|144279883|SUPERIORITY||Odds Ratio (OR)|0.82||||0.287|TWO_SIDED|95.0|0.56|1.19||We used an a priori threshold of p \< .05.|Regression, Logistic|||We conducted a logistic regression among the never enrolled group with the standard email as the reference group.||1.19|0.56|.287
72386058|NCT04289623|144279883|SUPERIORITY||Odds Ratio (OR)|1.05||||0.59|TWO_SIDED|95.0|0.87|1.27||We used an a priori threshold of p \< .05.|Regression, Logistic|||We conducted a logistic regression among the previously enrolled group with the rank-and-file email as the reference group.||1.27|0.87|.590
72386059|NCT04289623|144279883|SUPERIORITY||Odds Ratio (OR)|1.86||||0.035|TWO_SIDED|95.0|1.05|3.32||We used an a priori threshold of p \< .05.|Regression, Logistic|||We conducted a logistic regression among the never enrolled group with the rank-and-file email as the reference group.||3.32|1.05|.035
72386060|NCT04289623|144279884|SUPERIORITY||Odds Ratio (OR)|1.16||||0.085|TWO_SIDED|95.0|0.98|1.37||We used an a priori threshold of p \< .05.|Regression, Logistic|||We conducted a logistic regression among the previously enrolled group with the standard email as the reference group.||1.37|0.98|.085
72386061|NCT04289623|144279884|SUPERIORITY||Odds Ratio (OR)|0.89||||0.569|TWO_SIDED|95.0|0.6|1.33||We used an a priori threshold of p \< .05.|Regression, Logistic|||We conducted a logistic regression among the never enrolled group with the standard email as the reference group.||1.33|0.60|.569
72386062|NCT04289623|144279884|SUPERIORITY||Odds Ratio (OR)|0.79||||0.24|TWO_SIDED|95.0|0.54|1.17||We used an a priori threshold of p \< .05.|Regression, Logistic|||We conducted a logistic regression among the previously enrolled group with the rank-and-file email as the reference group.||1.17|0.54|.240
72386063|NCT04289623|144279884|SUPERIORITY||Odds Ratio (OR)|0.94||||0.871|TWO_SIDED|95.0|0.45|1.95||We used an a priori threshold of p \< .05.|Regression, Logistic|||We conducted a logistic regression among the never enrolled group with the rank-and-file email as the reference group.||1.95|0.45|.871
72386064|NCT00694707|144279912|SUPERIORITY_OR_OTHER||Least squares mean difference|-7.5||||0.0005|TWO_SIDED|95.0|-11.8|-3.3|||ANCOVA|The analysis of covariance (ANCOVA) included treatment group and study center as factors and the Baseline PANSS total score as the covariate.||||-3.3|-11.8|0.0005
72386065|NCT00694707|144279912|SUPERIORITY_OR_OTHER||Least squares mean difference|-8.8|||<|0.0001|TWO_SIDED|95.0|-13.1|-4.6|||ANCOVA|The analysis of covariance (ANCOVA) included treatment group and study center as factors and the Baseline PANSS total score as the covariate.||||-4.6|-13.1|<0.0001
72386066|NCT00694707|144279912|SUPERIORITY_OR_OTHER||Least squares mean difference|-10.4|||<|0.0001|TWO_SIDED|95.0|-14.6|-6.2|||ANCOVA|The analysis of covariance (ANCOVA) included treatment group and study center as factors and the Baseline PANSS total score as the covariate.||||-6.2|-14.6|<0.0001
72386067|NCT00694707|144279912|SUPERIORITY_OR_OTHER||Least squares mean difference|-15.0|||<|0.0001|TWO_SIDED|95.0|-19.4|-10.8|||ANCOVA|The analysis of covariance (ANCOVA) included treatment group and study center as factors and the Baseline PANSS total score as the covariate.||||-10.8|-19.4|<0.0001
72386068|NCT00694707|144279913|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.4||||0.004|TWO_SIDED|95.0|-0.6|-0.1|||ANCOVA|The analysis of covariance (ANCOVA) included treatment group and study center as factors and the Baseline CGI-S score as the covariate.||||-0.1|-0.6|0.0040
72386069|NCT00694707|144279913|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.5||||0.0003|TWO_SIDED|95.0|-0.7|-0.2|||ANCOVA|The analysis of covariance (ANCOVA) included treatment group and study center as factors and the Baseline CGI-S score as the covariate.||||-0.2|-0.7|0.0003
72386070|NCT00694707|144279913|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.6|||<|0.0001|TWO_SIDED|95.0|-0.9|-0.4|||ANCOVA|The analysis of covariance (ANCOVA) included treatment group and study center as factors and the Baseline CGI-S score as the covariate.||||-0.4|-0.9|<0.0001
72386071|NCT00694707|144279913|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.8|||<|0.0001|TWO_SIDED|95.0|-1.1|-0.6|||ANCOVA|The analysis of covariance (ANCOVA) included treatment group and study center as factors and the Baseline CGI-S score as the covariate.||||-0.6|-1.1|<0.0001
72386072|NCT03569033|144279918|OTHER||Difference in Least Squares Means|-0.32||||0.748|TWO_SIDED|95.0|-2.29|1.66|||Longitudinal Data Analysis|||||1.66|-2.29|0.748
72386073|NCT03569033|144279919|OTHER||Difference in Least Squares Means|0.99||||0.754|TWO_SIDED|95.0|-5.33|7.3|||ANCOVA|||||7.30|-5.33|0.754
72386074|NCT03569033|144279920|OTHER||Difference in Least Squares Means|0.8||||0.627|TWO_SIDED|95.0|-2.5|4.1|||ANCOVA|||||4.10|-2.50|0.627
72386075|NCT03569033|144279921|OTHER||Difference in Least Squares Means|0.09||||0.631|TWO_SIDED|95.0|-0.28|0.45|||ANCOVA|||||0.45|-0.28|0.631
72495338|NCT00915343|144519638|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5982|TWO_SIDED||||||Wilcoxon Signed Rank test|||||||0.5982
72438551|NCT00468052|144390517|NON_INFERIORITY_OR_EQUIVALENCE|Treatment with Dex would reduce the incidence of severe agitation be 50% with an 80% power (alpha 0.05)||||||0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Null hypothesis dexmedetomidine would be a safe and effective substitute to opiates in reducing pain and the incidence of severe EA||||.001
72386076|NCT03725852|144279929|SUPERIORITY||Least square (LS) mean difference|42.33|STANDARD_ERROR_OF_MEAN|61.483||0.495|TWO_SIDED|95.0|-81.84|166.49||P-value was based on an analysis of covariance (ANCOVA) model at each time point including treatment, sex, stratum (nintedanib, pirfenidone or neither), age, height, and baseline value as covariates.|ANCOVA|||Change at Week 26||166.49|-81.84|0.495
72386077|NCT03725852|144279930|SUPERIORITY||Difference in Percentage|1.7|||||TWO_SIDED|95.0|-17.3|24.5|||||95% CI for difference calculated using the method of Miettinen and Nurminen.|TEAEs||24.5|-17.3|
72386078|NCT03725852|144279930|SUPERIORITY||Difference in Percentage|15.7|||||TWO_SIDED|95.0|-3.0|30.7|||||95% CI for difference calculated using the method of Miettinen and Nurminen.|Serious TEAEs||30.7|-3.0|
72386079|NCT03725852|144279930|SUPERIORITY||Difference in Percentage|31.4|||||TWO_SIDED|95.0|8.2|49.4|||||95% CI for difference calculated using the method of Miettinen and Nurminen.|TEAEs related to study drug||49.4|8.2|
72386080|NCT03725852|144279930|SUPERIORITY||Difference in Percentage|22.2|||||TWO_SIDED|95.0|6.7|36.4|||||95% CI for difference calculated using the method of Miettinen and Nurminen.|TEAEs leading to study drug discontinuation||36.4|6.7|
72386081|NCT03725852|144279931|SUPERIORITY|||||||0.397|||||||Log Rank|||All-cause deaths||||0.397
72386082|NCT03725852|144279931|SUPERIORITY|||||||0.397|||||||Log Rank|||Respiratory-related deaths||||0.397
72386083|NCT03725852|144279931|SUPERIORITY|||||||0.131|||||||Log Rank|||All-cause hospitalizations||||0.131
72386084|NCT03725852|144279931|SUPERIORITY|||||||0.762|||||||Log Rank|||Respiratory-related hospitalizations||||0.762
72386085|NCT03725852|144279932|SUPERIORITY||Weighted LS mean difference|-9.11|STANDARD_ERROR_OF_MEAN|15.713||0.565|TWO_SIDED|95.0|-40.87|22.64||P-value was based on an ANCOVA model at Week 26 including treatment, stratum (nintedanib, pirfenidone or neither) and baseline 6MWT distance as covariates.|ANCOVA|||Change at Week 26||22.64|-40.87|0.565
72438552|NCT00468052|144390518|SUPERIORITY_OR_OTHER|||||||0.004|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.004
72495339|NCT00915343|144519639|SUPERIORITY_OR_OTHER_LEGACY||Mean difference|2.3||||0.0632|TWO_SIDED||||||Fisher's test|Fisher's non-parametric two-sample permutation test||||||0.0632
72495340|NCT00915343|144519640|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8676|TWO_SIDED||||||Wilcoxon Signed Rank test|||||||0.8676
72386086|NCT03725852|144279933|SUPERIORITY||Weighted LS mean difference.|-1.58|STANDARD_ERROR_OF_MEAN|3.71||0.673|TWO_SIDED|95.0|-9.06|5.91||P-value was based on an ANCOVA model at Week 26 including treatment, stratum (nintedanib, pirfenidone or neither) and baseline SGRQ value as covariates.|ANCOVA|||Change at Week 26||5.91|-9.06|0.673
72386087|NCT03725852|144279934|SUPERIORITY||Weighted LS mean difference|-0.72|STANDARD_ERROR_OF_MEAN|4.591||0.875|TWO_SIDED|95.0|-9.98|8.53||P-value was based on an ANCOVA model at Week 26 including treatment, stratum (nintedanib, pirfenidone or neither) and baseline SGRQ value as covariates.|ANCOVA|||Change at Week 26: Symptoms score||8.53|-9.98|0.875
72386088|NCT03725852|144279934|SUPERIORITY||Weighted LS mean difference|-4.14|STANDARD_ERROR_OF_MEAN|5.038||0.416|TWO_SIDED|95.0|-14.29|6.02||P-value was based on an ANCOVA model at Week 26 including treatment, stratum (nintedanib, pirfenidone or neither) and baseline SGRQ value as covariates.|ANCOVA|||Change at Week 26: Activity score||6.02|-14.29|0.416
72386089|NCT03725852|144279934|SUPERIORITY||Weighted LS mean difference|-0.2|STANDARD_ERROR_OF_MEAN|4.029||0.961|TWO_SIDED|95.0|-8.32|7.92||P-value was based on an ANCOVA model at Week 26 including treatment, stratum (nintedanib, pirfenidone or neither) and baseline SGRQ value as covariates.|ANCOVA|||Change at Week 26: Impacts score||7.92|-8.32|0.961
72386090|NCT03725852|144279935|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.000
72386091|NCT03072732|144279960|NON_INFERIORITY|The µ-Cor System will be considered non-inferior with respect to clinical performance (i.e., trends in fluid change) of the ZOE device if the lower 95% confidence interval of the differences (Primary Measurement) is greater than the non-inferiority margin of -0.05.|Mean Difference (Final Values)|0.66|||||TWO_SIDED|95.0|0.57|0.75|||||"Because the distribution was skewed, the average was calculated by 1) Fisher Transformation of values, 2) averaging the transformed values, 3) back calculating the mean.~The Taylor Series expansion and Delta method was used to determine variance."|"The null hypothesis was that the correlation coefficient of the ZOE device would be greater than the correlation coefficient of the uCor device by at least 0.05.~For each subject, a correlation coefficient was calculated between study arm 1 uCor readings and UFV, as well as ZOE readings and UFV.~The difference between uCor correlation coefficient and ZOE correlation coefficient for each subject was used as the Primary Measurement."||0.75|0.57|
72386092|NCT03072732|144279960|NON_INFERIORITY|The µ-Cor System will be considered non-inferior with respect to clinical performance (i.e., trends in fluid change) of the ZOE device if the lower 95% confidence interval of the differences (Primary Measurement) is greater than the non-inferiority margin of -0.05.|Mean Difference (Final Values)|0.23|||||TWO_SIDED|95.0|0.12|0.35|||||"Because the distribution was skewed, the average was calculated by 1) Fisher Transformation of values, 2) averaging the transformed values, 3) back calculating the mean.~The Taylor Series expansion and Delta method was used to determine variance."|"The null hypothesis was that the correlation coefficient of the ZOE device would be greater than the correlation coefficient of the uCor device by at least 0.05.~For each subject, a correlation coefficient was calculated between study arm 2 uCor readings and UFV, as well as ZOE readings and UFV.~The difference between uCor correlation coefficient and ZOE correlation coefficient for each subject was used as the Primary Measurement."||0.35|0.12|
72386093|NCT00973674|144279971|SUPERIORITY_OR_OTHER_LEGACY|||||||0.99|||||||Barnard's unconditional Exact Test|||||||0.99
72438553|NCT00468052|144390520|SUPERIORITY_OR_OTHER|||||||0.03|TWO_SIDED||||||Fisher Exact|||||||0.03
72438554|NCT00468052|144390521|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED||||||Fisher Exact|||||||0.02
72438555|NCT00457743|144390544|SUPERIORITY_OR_OTHER||Disease control Rate (percentage)|56.7||||||95.0|37.4|74.5|||||The disease control rate, defined as the percentage of subjects confirmed with CR, PR, and SD \>=10 weeks on study according to RECIST.|||74.5|37.4|
72495341|NCT00915343|144519641|SUPERIORITY_OR_OTHER_LEGACY|||||||0.97|TWO_SIDED||||||Wilcoxon Signed Rank test|||||||0.9700
72495342|NCT00915343|144519642|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2624|TWO_SIDED||||||Wilcoxon Signed Rank test|||||||0.2624
72495343|NCT00915343|144519643|SUPERIORITY_OR_OTHER_LEGACY||Mean difference|1.28|||||TWO_SIDED|||||||||||||
72386094|NCT00973674|144279972|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.67||||0.033|TWO_SIDED|95.0|0.74|3.77|||Log Rank|||||3.77|0.74|.033
72495344|NCT00915343|144519645|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||Sign test|||||||<0.0001
72495345|NCT00915343|144519646|SUPERIORITY_OR_OTHER_LEGACY||Mean difference|-272.3||||0.0034|TWO_SIDED||||||Wilcoxon Signed Rank test|||||||0.0034
72558756|NCT00385736|144647493|SUPERIORITY_OR_OTHER|||||||0.833||95.0||||The primary endpoint analysis was carried out in hierarchical order (as presented) to handle the multiplicity issues induced by the two adalimumab groups being compared to placebo and to control the overall alpha level of 0.05.|Chi-squared|||||||0.833
72558757|NCT00385736|144647494|SUPERIORITY_OR_OTHER|||||||0.107||95.0||||Ranked secondary analyses were carried out in hierarchical order (as presented) to handle the multiplicity issues and to control the overall alpha level of 0.05.|Chi-squared|||||||0.107
72558758|NCT00385736|144647495|SUPERIORITY_OR_OTHER|||||||0.382||95.0||||Ranked secondary analyses were carried out in hierarchical order (as presented) to handle the multiplicity issues and to control the overall alpha level of 0.05.|Chi-squared|||||||0.382
72558759|NCT00385736|144647496|SUPERIORITY_OR_OTHER|||||||0.038||95.0||||Ranked secondary analyses were carried out in hierarchical order (as presented) to handle the multiplicity issues and to control the overall alpha level of 0.05.|Chi-squared|||||||0.038
72558760|NCT00385736|144647497|SUPERIORITY_OR_OTHER|||||||0.035||95.0||||Ranked secondary analyses were carried out in hierarchical order (as presented) to handle the multiplicity issues and to control the overall alpha level of 0.05.|Chi-squared|||||||0.035
72558761|NCT00385736|144647498|SUPERIORITY_OR_OTHER|||||||0.08||95.0||||Ranked secondary analyses were carried out in hierarchical order (as presented) to handle the multiplicity issues and to control the overall alpha level of 0.05.|Chi-squared|||||||0.080
72558762|NCT00385736|144647499|SUPERIORITY_OR_OTHER|||||||0.264||95.0||||Ranked secondary analyses were carried out in hierarchical order (as presented) to handle the multiplicity issues and to control the overall alpha level of 0.05.|Chi-squared|||||||0.264
72558763|NCT00385736|144647500|SUPERIORITY_OR_OTHER|||||||0.526||95.0||||Ranked secondary analyses were carried out in hierarchical order (as presented) to handle the multiplicity issues and to control the overall alpha level of 0.05.|Chi-squared|||||||0.526
72558764|NCT00385736|144647501|SUPERIORITY_OR_OTHER|||||||0.506||95.0||||Ranked secondary analyses were carried out in hierarchical order (as presented) to handle the multiplicity issues and to control the overall alpha level of 0.05.|Chi-squared|||||||0.506
72558765|NCT00385736|144647502|SUPERIORITY_OR_OTHER|||||||0.264||95.0||||Ranked secondary analyses were carried out in hierarchical order (as presented) to handle the multiplicity issues and to control the overall alpha level of 0.05.|Chi-squared|||||||0.264
72558766|NCT00385736|144647503|SUPERIORITY_OR_OTHER|||||||0.797||95.0||||Ranked secondary analyses were carried out in hierarchical order (as presented) to handle the multiplicity issues and to control the overall alpha level of 0.05.|Chi-squared|||||||0.797
72558767|NCT00385736|144647504|SUPERIORITY_OR_OTHER|||||||0.614||95.0||||Ranked secondary analyses were carried out in hierarchical order (as presented) to handle the multiplicity issues and to control the overall alpha level of 0.05.|Chi-squared|||||||0.614
72558768|NCT00385736|144647505|SUPERIORITY_OR_OTHER|||||||0.532||95.0||||Ranked secondary analyses were carried out in hierarchical order (as presented) to handle the multiplicity issues and to control the overall alpha level of 0.05.|Chi-squared|||||||0.532
72386095|NCT00973674|144279973|SUPERIORITY_OR_OTHER_LEGACY|||||||0.35|||||||t-test, 2 sided|||||||.35
72386096|NCT00116428|144279975|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Log Rank|||The study null hypothesis is that the chronic success rates for the THERMOCOOL and AAD groups are equal.||||<0.001
72386097|NCT03452228|144279980|SUPERIORITY||Median Difference (Final Values)|-43.5|||||TWO_SIDED|95.0|-89.4|1238.9||||||||1238.9|-89.4|
72386098|NCT03452228|144279980|SUPERIORITY||Median Difference (Final Values)|-75.5|||||TWO_SIDED|95.0|-82.2|121.2||||||||121.2|-82.2|
72386099|NCT02713204|144279994|SUPERIORITY|Analysis was performed using analysis of covariance (ANCOVA) model with baseline measurement as a covariate and treatment group as fixed factors.|Least square mean difference|0.02||||0.9894|TWO_SIDED|95.0|-2.99|3.03||Threshold for significance at 0.05 level.|ANCOVA|||||3.03|-2.99|0.9894
72386100|NCT02713204|144279994|SUPERIORITY||Least square mean difference|0.25||||0.8346|TWO_SIDED|95.0|-2.09|2.59|||ANCOVA|||Analysis was performed using analysis of covariance (ANCOVA) model with baseline measurement as a covariate and treatment group as fixed factors.||2.59|-2.09|0.8346
72386101|NCT02713204|144279995|SUPERIORITY||Least square mean difference|-1.2||||0.4611|TWO_SIDED|95.0|-4.41|2.0||Threshold for significance at 0.05 level.|ANCOVA|||Analysis was performed using ANCOVA model with baseline measurement as a covariate, and treatment group and BCVA stratification variable as fixed factors.||2.00|-4.41|0.4611
72386102|NCT02713204|144279995|SUPERIORITY|Threshold for significance at 0.05 level.|Least square mean difference|-2.0||||0.2225|TWO_SIDED|95.0|-5.22|1.22|||ANCOVA|||Analysis was performed using ANCOVA model with baseline measurement as a covariate, and treatment group and BCVA stratification variable as fixed factors.||1.22|-5.22|0.2225
72386103|NCT02713204|144279995|SUPERIORITY||Least square mean difference|-0.82||||0.6063|TWO_SIDED|95.0|-3.97|2.32||Threshold for significance at 0.05 level.|ANCOVA|||Analysis was performed using ANCOVA model with baseline measurement as a covariate, and treatment group and BCVA stratification variable as fixed factors.||2.32|-3.97|0.6063
72386104|NCT02713204|144279995|SUPERIORITY||Least square mean difference|-3.25||||0.0426|TWO_SIDED|95.0|-6.39|-0.11||Threshold for significance at 0.05 level.|ANCOVA|||Analysis was performed using ANCOVA model with baseline measurement as a covariate, and treatment group and BCVA stratification variable as fixed factors.||-0.11|-6.39|0.0426
72495346|NCT01920711|144519647|SUPERIORITY||Rate Ratio|0.8698||||0.0587|TWO_SIDED|95.0|0.7526|1.0052||1-sided p-value 0.0294|Proportional Rates Model (LWYY)|Treatment as fixed-effect factor and stratified by region and with robust variance estimate.||Primary Composite Events||1.0052|0.7526|0.0587
72558769|NCT00835666|144647516|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Geometric Test/Ref Ratio x 100|98.5||||||90.0|92.6|105.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||105|92.6|
72558770|NCT00835666|144647517|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Geometric Test/Ref Ratio x 100|98.2||||||90.0|94.7|102.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||102|94.7|
72386105|NCT02713204|144279995|SUPERIORITY||Least square mean difference|-4.39||||0.0073|TWO_SIDED|95.0|-7.58|-1.19||Threshold for significance at 0.05 level.|ANCOVA|||Analysis was performed using ANCOVA model with baseline measurement as a covariate, and treatment group and BCVA stratification variable as fixed factors.||-1.19|-7.58|0.0073
72386106|NCT02713204|144279995|SUPERIORITY||Least square mean difference|1.17||||0.469|TWO_SIDED|95.0|-2.01|4.36||Threshold for significance at 0.05 level.|ANCOVA|||Analysis was performed using ANCOVA model with baseline measurement as a covariate, and treatment group and BCVA stratification variable as fixed factors.||4.36|-2.01|0.4690
72386107|NCT02713204|144279995|SUPERIORITY||Least square mean difference|2.42||||0.1267|TWO_SIDED|95.0|-0.69|5.54||Threshold for significance at 0.05 level.|ANCOVA|||Analysis was performed using ANCOVA model with baseline measurement as a covariate, and treatment group and BCVA stratification variable as fixed factors.||5.54|-0.69|0.1267
72386108|NCT02713204|144279996|SUPERIORITY||Least square mean difference|-11.57||||0.413|TWO_SIDED|95.0|-39.5|16.2||Threshold for significance at 0.05 level.|ANCOVA|||Analysis was performed using analysis of covariance (ANCOVA) model with baseline measurement as a covariate and treatment group as fixed factors.||16.20|-39.5|0.4130
72386109|NCT02713204|144279996|SUPERIORITY||Least square mean difference|-4.88||||0.6587|TWO_SIDED|95.0|-26.2|16.85|||ANCOVA|||Analysis was performed using analysis of covariance (ANCOVA) model with baseline measurement as a covariate and treatment group as fixed factors.||16.85|-26.2|0.6587
72386110|NCT02713204|144279997|SUPERIORITY||Least square mean difference|17.04||||0.3833|TWO_SIDED|95.0|-21.35|55.43||Threshold for significance at 0.05 level.|ANCOVA|||Analysis was performed using ANCOVA model with baseline measurement as a covariate, and treatment group and BCVA stratification variable as fixed factors.||55.43|-21.35|0.3833
72386111|NCT02713204|144279997|SUPERIORITY||Least square mean difference|12.85||||0.5141|TWO_SIDED|95.0|-25.84|51.53||Threshold for significance at 0.05 level.|ANCOVA|||Analysis was performed using ANCOVA model with baseline measurement as a covariate, and treatment group and BCVA stratification variable as fixed factors.||51.53|-25.84|0.5141
72386112|NCT02713204|144279997|SUPERIORITY||Least square mean difference|33.89||||0.0785|TWO_SIDED|95.0|-3.89|71.67|||ANCOVA|||Analysis was performed using ANCOVA model with baseline measurement as a covariate, and treatment group and BCVA stratification variable as fixed factors.||71.67|-3.89|0.0785
72386113|NCT02713204|144279997|SUPERIORITY||Least square mean difference|42.27||||0.0281|TWO_SIDED|95.0|4.56|79.98||Threshold for significance at 0.05 level.|ANCOVA|||Analysis was performed using ANCOVA model with baseline measurement as a covariate, and treatment group and BCVA stratification variable as fixed factors.||79.98|4.56|0.0281
72386114|NCT02713204|144279997|SUPERIORITY||Least square mean difference|16.65||||0.3934|TWO_SIDED|95.0|-21.67|54.96||Threshold for significance at 0.05 level.|ANCOVA|||||54.96|-21.67|0.3934
72386115|NCT02713204|144279997|SUPERIORITY||Least square mean difference|21.05||||0.279|TWO_SIDED|95.0|-17.13|59.22||Threshold for significance at 0.05 level.|ANCOVA|||Analysis was performed using ANCOVA model with baseline measurement as a covariate, and treatment group and BCVA stratification variable as fixed factors.||59.22|-17.13|0.2790
72386116|NCT02713204|144279997|SUPERIORITY||Least square mean difference|-8.38||||0.6586|TWO_SIDED|95.0|-45.64|28.88||Threshold for significance at 0.05 level.|ANCOVA|||Analysis was performed using ANCOVA model with baseline measurement as a covariate, and treatment group and BCVA stratification variable as fixed factors.||28.88|-45.64|0.6586
72386117|NCT02713204|144279998|SUPERIORITY||Least square mean difference|0.55||||0.4889|TWO_SIDED|95.0|-1.01|2.1||Threshold for significance at 0.05 level.|ANCOVA|||||2.10|-1.01|0.4889
72386118|NCT02713204|144279998|SUPERIORITY||Least square mean difference|0.24||||0.7027|TWO_SIDED|95.0|-0.99|1.46||Threshold for significance at 0.05 level.|ANCOVA|||||1.46|-0.99|0.7027
72386119|NCT02713204|144279999|SUPERIORITY||Least square mean difference|-0.6||||0.4927|TWO_SIDED|95.0|-2.34|1.13||Threshold for significance at 0.05 level.|ANCOVA|||||1.13|-2.34|0.4927
72495347|NCT01920711|144519647|SUPERIORITY||Rate Ratio|0.8511||||0.0556|TWO_SIDED|95.0|0.7216|1.0039||1-sided p-value 0.0278|Joint Frality Model|Treatment and region as fixed-effect factors||Total Hospitalizations for heart failure||1.0039|0.7216|0.0556
72495348|NCT01920711|144519647|SUPERIORITY||Hazard Ratio (HR)|0.9531||||0.6241|TWO_SIDED|95.0|0.7863|1.1551||1-sided p-value 0.3120|Cox's proportional hazard model|||Cardiovascular Death||1.1551|0.7863|0.6241
72386120|NCT02713204|144279999|SUPERIORITY||Least square mean difference|0.38||||0.6645|TWO_SIDED|95.0|-1.36|2.13||Threshold for significance at 0.05 level.|ANCOVA|||||2.13|-1.36|0.6645
72386121|NCT02713204|144279999|SUPERIORITY||Least square mean difference|-0.89||||0.3091|TWO_SIDED|95.0|-2.61|0.83||Threshold for significance at 0.05 level.|ANCOVA|||||0.83|-2.61|0.3091
72386122|NCT02713204|144279999|SUPERIORITY||Least square mean difference|-0.6||||0.4898|TWO_SIDED|95.0|-2.29|1.1||Threshold for significance at 0.05 level.|ANCOVA|||||1.10|-2.29|0.4898
72386123|NCT02713204|144279999|SUPERIORITY||Least square mean difference|-0.8||||0.3504|TWO_SIDED|95.0|-2.5|0.89||Threshold for significance at 0.05 level.|ANCOVA|||||0.89|-2.50|0.3504
72386124|NCT02713204|144279999|SUPERIORITY||Least square mean difference|-0.98||||0.2632|TWO_SIDED|95.0|-2.7|0.74||Threshold for significance at 0.05 level.|ANCOVA|||||0.74|-2.70|0.2632
72386125|NCT02713204|144279999|SUPERIORITY||Least square mean difference|0.21||||0.8056|TWO_SIDED|95.0|-1.46|1.88||Threshold for significance at 0.05 level.|ANCOVA|||||1.88|-1.46|0.8056
72386126|NCT02713204|144280000|SUPERIORITY||Least square mean difference|0.57||||0.5065|TWO_SIDED|95.0|-1.11|2.25||Threshold for significance at 0.05 level.|ANCOVA|||||2.25|-1.11|0.5065
72386127|NCT02713204|144280000|SUPERIORITY||Least square mean difference|-0.22||||0.7418|TWO_SIDED|95.0|-1.55|1.1||Threshold for significance at 0.05 level.|ANCOVA|||||1.10|-1.55|0.7418
72386128|NCT02713204|144280001|SUPERIORITY||Least square mean difference|-0.19||||0.8383|TWO_SIDED|95.0|-1.99|1.62||Threshold for significance at 0.05 level.|ANCOVA|||||1.62|-1.99|0.8383
72386129|NCT02713204|144280001|SUPERIORITY||Least square mean difference|-0.1||||0.918|TWO_SIDED|95.0|-1.91|1.72||Threshold for significance at 0.05 level.|ANCOVA|||||1.72|-1.91|0.9180
72386130|NCT02713204|144280001|SUPERIORITY||Least square mean difference|-1.41||||0.1238|TWO_SIDED|95.0|-3.2|0.39||Threshold for significance at 0.05 level.|ANCOVA|||||0.39|-3.20|0.1238
72386131|NCT02713204|144280001|SUPERIORITY||Least square mean difference|-0.97||||0.2819|TWO_SIDED|95.0|-2.73|0.8||Threshold for significance at 0.05 level.|ANCOVA|||||0.80|-2.73|0.2819
72386132|NCT02713204|144280001|SUPERIORITY||Least square mean difference|-1.02||||0.2581|TWO_SIDED|95.0|-2.78|0.75||Threshold for significance at 0.05 level.|ANCOVA|||||0.75|-2.78|0.2581
72438556|NCT00457743|144390546|SUPERIORITY_OR_OTHER||Objective Response Rate(percentage)|13.3||||||95.0|3.8|30.7|||||The subjects confirmed with complete response (CR) and partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST).|||30.7|3.8|
72438557|NCT00457743|144390555|SUPERIORITY_OR_OTHER||CBR rate (percentage)|40.0||||||95.0|22.7|59.4|||||The clinical benefit response (CBR) rate, defined as the percentage of the subjects confirmed with CR, PR, or SD\>=22 weeks on study according to Response Evaluation Criteria in Solid Tumors (RECIST).|||59.4|22.7|
72438558|NCT00566527|144390558|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared when the lower bound of the 95% CI was \> -5. Values are shown as percentages.|Measles Response Rate (Arm 2 - Arm 3)|-0.91|||||TWO_SIDED|95.0|-2.82|0.87||||||Measles difference||0.87|-2.82|
72438559|NCT00566527|144390558|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared when the lower bound of the 95% CI was \> -5. Values are shown as percentages.|Mumps Response Rate (Arm 2 - Arm 3)|0.03|||||TWO_SIDED|95.0|-1.2|1.32||||||Mumps difference||1.32|-1.20|
72438560|NCT00566527|144390558|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared when the lower bound of the 95% CI was \> -5. Values are shown as percentages.|Rubella Response Rate (Arm 2 - Arm 3)|-0.22|||||TWO_SIDED|95.0|-1.55|1.03||||||Rubella difference||1.03|-1.55|
72438561|NCT00566527|144390558|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared when the lower bound of the 95% CI was \> -10. Values are shown as percentages.|Varicella Response Rate (Arm 2 - Arm 3)|0.0|||||TWO_SIDED|95.0|-1.28|1.1||||||Varicella difference||1.10|-1.28|
72438562|NCT00566527|144390559|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared when the lower bound of the 95% CI was \> -5. Values are shown as percentages.|Measles Response Rate (Arm 1 - Arm 3)|-3.97|||||TWO_SIDED|95.0|-6.44|-1.87||||||Measles difference||-1.87|-6.44|
72438563|NCT00566527|144390559|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared when the lower bound of the 95% CI was \> -5. Values are shown as percentages.|Mumps Response Rate (Arm 1 - Arm 3)|-0.35|||||TWO_SIDED|95.0|-1.71|1.01||||||Mumps difference||1.01|-1.71|
72438564|NCT00566527|144390559|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared when the lower bound of the 95% CI was \> -5. Values are shown as percentages.|Rubella Response Rate (Arm 1 - Arm 3)|-0.15|||||TWO_SIDED|95.0|-1.34|1.09||||||Rubella difference||1.09|-1.34|
72438565|NCT00566527|144390559|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared when the lower bound of the 95% CI was \> -10. Values are shown as percentages.|Varicella Response Rate (Arm 1 - Arm 3)|0.0|||||TWO_SIDED|95.0|-1.83|1.1||||||Varicella difference||1.10|-1.83|
72438566|NCT02928224|144390599|OTHER||||||<|0.0001|||||||Stratified Log-rank|||||||<0.0001
72438567|NCT02928224|144390600|OTHER||||||<|0.0001|||||||Stratified Log-rank|||||||<0.0001
72438568|NCT02928224|144390601|OTHER||||||<|0.0001|||||||Chi-squared|||||||<0.0001
72438569|NCT02928224|144390610|OTHER||||||<|0.0001|||||||Stratified Log-rank|||||||<0.0001
72438570|NCT02928224|144390611|OTHER|||||||0.5958|||||||Stratified Log-rank|||||||0.5958
72438571|NCT02928224|144390612|OTHER||||||<|0.0001|||||||Stratified Log-rank|||||||<0.0001
72438572|NCT02928224|144390613|OTHER||||||<|0.0001|||||||Stratified Log-rank|||||||<0.0001
72438573|NCT02928224|144390614|OTHER||||||<|0.0001|||||||Stratified Log-rank|||||||<0.0001
72438574|NCT02928224|144390615|OTHER||||||<|0.0001|||||||Stratified Log-rank|||||||<0.0001
72438575|NCT02928224|144390616|OTHER|||||||0.1004|||||||Stratified Log-rank|||||||0.1004
72438576|NCT02928224|144390617|OTHER|||||||0.3724|||||||Stratified Log-rank|||||||0.3724
72438577|NCT02928224|144390618|OTHER||||||<|0.0001|||||||Chi-squared|||||||<0.0001
72438578|NCT02928224|144390619|OTHER||||||<|0.0001|||||||Chi-squared|||||||<0.0001
72438579|NCT02928224|144390620|OTHER||||||<|0.0001|||||||Chi-squared|||||||<0.0001
72438580|NCT02928224|144390621|OTHER|||||||0.1928|||||||Cochran-Mantel-Haenszel|||||||0.1928
72438581|NCT02928224|144390622|OTHER|||||||0.0357|||||||Cochran-Mantel-Haenszel|||||||0.0357
72438582|NCT00468910|144390678|SUPERIORITY_OR_OTHER|||||||0.11|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||The study was powered to detect an attributable change in the aspirin group of 50% relative to baseline values - an approximate 50% increase in spectral slope.||||0.11
72438583|NCT00468910|144390679|SUPERIORITY_OR_OTHER|||||||0.17|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.17
72438584|NCT04090190|144390727|SUPERIORITY|||||||0.6497|||||||Wilcoxon (Mann-Whitney)|||T-test of Wilcoxon rank sum was used to test this non-normal data. Null hypothesis is that the concentration of urine inflammatory markers is the same at baseline and follow-up. This p-value is the probability that the difference in the CRP Calc. Conc. (pg/ml) between baseline and follow-up.||||0.6497
72438585|NCT04090190|144390727|SUPERIORITY|||||||0.4281|||||||Wilcoxon (Mann-Whitney)|||T-test of Wilcoxon rank sum was used to test this non-normal data. Null hypothesis is that the concentration of urine inflammatory markers is the same at baseline and follow-up. This p-value is the probability that the difference in the IL-12/IL-23p40 Calc. Conc. (pg/ml) between baseline and follow-up.||||0.4281
72438586|NCT04090190|144390727|SUPERIORITY|||||||0.3157|||||||Wilcoxon (Mann-Whitney)|||The null hypothesis is that the baseline and follow-up levels of the urine inflammatory markers are due to chance. This p-value represents the probability that the difference between the baseline and follow-up levels of MCP-1 Calc. Conc. (pg/ml) is due to chance.||||0.3157
72438587|NCT04090190|144390727|SUPERIORITY|||||||0.1463|||||||Wilcoxon (Mann-Whitney)|||This p-value represents the probability that the difference between baseline and follow-up levels of GM-CSF Calc. Conc. (pg/ml) is due to chance.||||0.1463
72438588|NCT04090190|144390727|SUPERIORITY|||||||0.6091|||||||Wilcoxon (Mann-Whitney)|||The null hypothesis is that the baseline and follow-up levels of the urine inflammatory markers are due to chance. This p-value represents the probability that the difference between the baseline and follow-up levels of IL-1β Calc. Conc. (pg/ml) is due to chance.||||0.6091
72438589|NCT04090190|144390727|SUPERIORITY|||||||0.3011|||||||Wilcoxon (Mann-Whitney)|||The null hypothesis is that the baseline and follow-up levels of the urine inflammatory markers are due to chance. This p-value represents the probability that the difference between the baseline and follow-up levels of IL-6 Calc. Conc. (pg/ml) is due to chance.||||0.3011
72438590|NCT04090190|144390727|SUPERIORITY|||||||0.5009|||||||Wilcoxon (Mann-Whitney)|||The null hypothesis is that the baseline and follow-up levels of the urine inflammatory markers are due to chance. This p-value represents the probability that the difference between the baseline and follow-up levels of IL-8 Calc. Conc. (pg/ml) is due to chance.||||0.5009
72495349|NCT01920711|144519648|SUPERIORITY||Least Squares Mean of Difference|1.0264||||0.051|TWO_SIDED|95.0|-0.0047|2.0576|||Mixed Models Analysis|||Clinical Summary Score||2.0576|-0.0047|0.0510
72495350|NCT01920711|144519649|SUPERIORITY||Odds Ratio (OR)|1.4475||||0.0035|TWO_SIDED|95.0|1.1294|1.8552|||Repeated measures cumulative odds model|The response variable is the change from baseline to any scheduled time points up to Month 8.||NYHA Class Change||1.8552|1.1294|0.0035
72495351|NCT01920711|144519650|SUPERIORITY||Hazard Ratio (HR)|0.5041||||0.0014|TWO_SIDED|95.0|0.3312|0.7673|||Cox's proportional hazards model|Treatment as fixed factor and stratified by region.||Composite renal endpoint||0.7673|0.3312|0.0014
72558771|NCT00835666|144647518|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Geometric Test/Ref Ratio x 100|98.4||||||90.0|94.9|102.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||102|94.9|
72618883|NCT01260324|144768303|SUPERIORITY_OR_OTHER_LEGACY||Incidence rate per 1000 person-years|0.05|||||TWO_SIDED|95.0|0.04|0.05|||||Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.|Incidence rate Year 2003||0.05|0.04|
72618884|NCT01260324|144768303|SUPERIORITY_OR_OTHER_LEGACY||Incidence rate per 1000 person-years|0.05|||||TWO_SIDED|95.0|0.04|0.05|||||Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.|Incidence rate Year 2004||0.05|0.04|
72386133|NCT02713204|144280001|SUPERIORITY||Least square mean difference|-0.87||||0.339|TWO_SIDED|95.0|-2.66|0.92||Threshold for significance at 0.05 level.|ANCOVA|||||0.92|-2.66|0.3390
72386134|NCT02713204|144280001|SUPERIORITY||Least square mean difference|0.05||||0.9558|TWO_SIDED|95.0|-1.69|1.79||Threshold for significance at 0.05 level.|ANCOVA|||||1.79|-1.69|0.9558
72386135|NCT04402060|144280010|SUPERIORITY||Hazard Ratio (HR)|0.98||||0.82|TWO_SIDED|90.0|0.63|1.51|||Log Rank|||P-value was from a 2-sided stratified Log-rank test by the randomization stratification factors (need of mechanical ventilation \[yes vs no\] and age \[\<65 years vs ≥65 years\]) at 0.1 significant level for evaluation of treatment difference. Hazard ratio was obtained from a Cox regression model with treatment and the randomization stratification factors as fixed factors and 90% confidence interval (CI) was based on the Wald method.||1.51|0.63|0.82
72386136|NCT04402060|144280011|SUPERIORITY||Hazard Ratio (HR)|1.62||||0.36|TWO_SIDED|90.0|0.77|3.4|||Log Rank|||P-value was from a 2-sided stratified Log-rank test by the randomization stratification factors (need of mechanical ventilation \[yes vs no\] and age \[\<65 years vs ≥65 years\]) at 0.1 significant level for evaluation of treatment difference. Hazard ratio was obtained from a Cox regression model with treatment and the randomization stratification factors as fixed factors and 90% CI was based on the Wald method.||3.40|0.77|0.36
72386137|NCT04402060|144280013|SUPERIORITY||Hazard Ratio (HR)|0.09||||0.03|TWO_SIDED|90.0|0.01|0.51|||Log Rank|||P-value was from a 2-sided stratified Log-rank test by the randomization stratification factors (need of mechanical ventilation \[yes vs no\] and age \[\<65 years vs ≥65 years\]) at 0.1 significant level for evaluation of treatment difference. Hazard ratio was obtained from a Cox regression model with treatment and the randomization stratification factors as fixed factors and 90% CI was based on the Wald method.||0.51|0.01|0.03
72386138|NCT04402060|144280014|SUPERIORITY||Hazard Ratio (HR)|1.09||||0.93|TWO_SIDED|90.0|0.69|1.72|||Log Rank|||P-value was from a 2-sided stratified Log-rank test by the randomization stratification factors (need of mechanical ventilation \[yes vs no\] and age \[\<65 years vs ≥65 years\]) at 0.1 significant level for evaluation of treatment difference. Hazard ratio was obtained from a Cox regression model with treatment and the randomization stratification factors as fixed factors and 90% CI was based on the Wald method.||1.72|0.69|0.93
72386139|NCT02572609|144280044|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence in the Cmax will be concluded if the 90% confidence interval for the test/reference ratio of the least squares means is fully contained within the acceptance range, 80.00% - 125.00%.|T/R Ratio|113.56|STANDARD_DEVIATION|16.24||0.0082|TWO_SIDED|90.0|106.48|121.1|||Anderson-Hauck procedure||Standard Deviation is actually the Coefficient of variation intra subject (CVintra).|||121.10|106.48|0.0082
72386140|NCT02572609|144280045|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence in the AUC0-t will be concluded if the 90% confidence interval for the test/reference ratio of the least squares means is fully contained within the acceptance range, 80.00% - 125.00%.|T/R Ratio|119.61|STANDARD_DEVIATION|10.65||0.0438|TWO_SIDED|90.0|114.65|124.79|||Anderson-Hauck procedure||Standard Deviation is actually the Coefficient of variation intra subject (CVintra).|||124.79|114.65|0.0438
72386141|NCT02345226|144280052|NON_INFERIORITY|A sample size of 400 HIV-1 infected participants per treatment group would provide 95% power to detect a non-inferiority margin of 8% in the Week 48 response rate difference between the FTC/RPV/TAF group and EFV/FTC/TDF group. For sample size and power computation, it is assumed that both treatment groups will have a response rate of 89% (based on Gilead Study GS-US-292-0109), that a noninferiority margin is 8%, and that the significance level of the test is at a one-sided alpha level of 0.025.|Difference in Percentages|-2.0|||||TWO_SIDED|95.001|-5.9|1.8|||||The difference in percentages and its 95.001% confidence interval (CI) were calculated based on an unconditional exact method using 2 inverted 1-sided tests.|The null hypothesis was that the percentage of participants with HIV-1 RNA \< 50 copies/mL at Week 48 in the FTC/RPV/TAF group was at least 8% lower than the rate in the EFV/FTC/TDF group; the alternative hypothesis was that the percentage of participants with HIV-1 RNA \< 50 copies/mL in the FTC/RPV/TAF group was less than 8% lower than that in the EFV/FTC/TDF group.||1.8|-5.9|
72386142|NCT02345226|144280052|SUPERIORITY|||||||0.35|||||||Fisher Exact|||||||0.35
72386143|NCT01313858|144280105|SUPERIORITY_OR_OTHER|||||||0.0007|||||||Repeated measures analysis|||Least squares mean difference from baseline in FFbH at Month 3 (Month 3 minus BL)||||0.0007
72386144|NCT01313858|144280105|SUPERIORITY_OR_OTHER|||||||0.0007|||||||Repeated measures analysis|||Least squares mean difference from baseline in FFbH at Month 6 (Month 6 minus BL)||||0.0007
72386145|NCT01313858|144280105|SUPERIORITY_OR_OTHER|||||||0.0011|||||||Repeated measures analysis|||Least squares mean difference from baseline in FFbH at Month 9 (Month 9 minus BL)||||0.0011
72386146|NCT01313858|144280105|SUPERIORITY_OR_OTHER|||||||0.0015|||||||Repeated measures analysis|||Least squares mean difference from baseline in FFbH at Month 12 (Month 12 minus BL)||||0.0015
72386147|NCT01313858|144280105|SUPERIORITY_OR_OTHER|||||||0.0029|||||||Repeated measures analysis|||Least squares mean difference from baseline in FFbH at Month 15 (Month 15 minus BL)||||0.0029
72386148|NCT01313858|144280105|SUPERIORITY_OR_OTHER|||||||0.0004|||||||Repeated measures analysis|||Least squares mean difference from baseline in FFbH at Month 18 (Month 18 minus BL)||||0.0004
72438591|NCT00457691|144390730|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.095||||0.8072|TWO_SIDED|95.0|0.892|1.344||p-value from 1-sided log-rank test, stratified by Eastern Cooperative Oncology Group (ECOG) performance status, organ sites with disease, primary tumor site, prior adjuvant treatment|Log Rank|||||1.344|0.892|0.8072
72438592|NCT00457691|144390731|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.171||||0.9163|TWO_SIDED|95.0|0.936|1.466||p-value from 1-sided log-rank test, stratified by ECOG performance status, organ sites with disease, primary tumor site, prior adjuvant treatment|Log Rank|||||1.466|0.936|0.9163
72438593|NCT02079844|144390768|SUPERIORITY_OR_OTHER||LS Mean Difference|0.232|STANDARD_ERROR_OF_MEAN|0.7313||0.753|TWO_SIDED|95.0|-1.269|1.733||P-values are from ANOVA with treatment sequence, study period, and treatment as fixed effects and subject nested within treatment sequence as a random effect.|ANOVA|||||1.733|-1.269|0.753
72438594|NCT02079844|144390768|SUPERIORITY_OR_OTHER||LS Mean Difference|0.133|STANDARD_ERROR_OF_MEAN|0.7417||0.859|TWO_SIDED|95.0|-1.389|1.655||P-values are from ANOVA with treatment sequence, study period, and treatment as fixed effects and subject nested within treatment sequence as a random effect.|ANOVA|||||1.655|-1.389|0.859
72438595|NCT02079844|144390769|SUPERIORITY_OR_OTHER||LS Mean Difference|1.938|STANDARD_ERROR_OF_MEAN|1.2436||0.131|TWO_SIDED|95.0|-0.614|4.49||P-values are from ANOVA with treatment sequence, study period, and treatment as fixed effects and subject nested within treatment sequence as a random effect.|ANOVA|||||4.490|-0.614|0.131
72438596|NCT02079844|144390769|SUPERIORITY_OR_OTHER||LS Mean Difference|2.377|STANDARD_ERROR_OF_MEAN|1.2545||0.069|TWO_SIDED|95.0|-0.198|4.951||P-values are from ANOVA with treatment sequence, study period, and treatment as fixed effects and subject nested within treatment sequence as a random effect.|ANOVA|||||4.951|-0.198|0.069
72438597|NCT02079844|144390770|SUPERIORITY_OR_OTHER||LS Mean Difference|0.076|STANDARD_ERROR_OF_MEAN|0.1757||0.671|TWO_SIDED|95.0|-0.739|0.106||P-values are from ANOVA with treatment sequence, study period, and treatment as fixed effects and subject nested within treatment sequence as a random effect.|ANOVA|||||0.106|-0.739|0.671
72438598|NCT02079844|144390770|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.171|STANDARD_ERROR_OF_MEAN|0.1757||0.345|TWO_SIDED|95.0|-1.193|0.571||P-values are from ANOVA with treatment sequence, study period, and treatment as fixed effects and subject nested within treatment sequence as a random effect.|ANOVA|||||0.571|-1.193|0.345
72438599|NCT01420549|144390785|NON_INFERIORITY|The non-inferiority assessment was analyzed by the bilateral confidence interval (95%) for the ratio of the mean LDLfinal/LDLbaseline of the R/E combination, compared to the mean LDLfinal/LDLbaseline of the S/E combination and the bilateral confidence interval (95%) for the difference between the two means of the percentage variation of LDL-C in the treatments (\[(LDLfinal - LDLbaseline)/LDLbaseline))\*100)R+E\] - \[(LDLfinal - LDLbaseline)/LDLbaseline))\*100)S+E\].|Median Difference (Final Values)|-10.32|STANDARD_ERROR_OF_MEAN|3.33||0.0013|TWO_SIDED|95.0|-16.94|-3.7|||ANCOVA|Estimates for treatment effect and their 95% confidence intervals were exponentiated to produce estimates of percentage change.|Mean Percentage Change LDL- C (%)|Rosuvastatin + Ezetimibe versus Simvastatin + Ezetimibe||-3.70|-16.94|0.0013
72438600|NCT02755805|144390801|SUPERIORITY_OR_OTHER||Cohen's d effect size at month 6|1.11||||0.007|TWO_SIDED|||||a priori threshold set at p\<0.05|Mixed Models Analysis|"F(3,74)=4.37~P-values were calculated using mixed model analyses and controlled for stoke severity as a covariate."|Effect size was calculated using mean change scores (baseline to month 6) and standard error of change (baseline to month 6) for each group.|All analyses were performed using the intent-to-treat principle so that comparisons were made according to the assigned intervention group regardless of study completion.||||0.007
72438601|NCT02755805|144390802|SUPERIORITY_OR_OTHER||Cohen's d effect size at month 6|0.76||||0.09|TWO_SIDED|||||a priori threshold set at p\<0.05|Mixed Models Analysis|F(2,34)=2.55|Effect size was calculated using mean change scores (baseline to month 6) and standard error of change (baseline to month 6) for each group.|All analyses were performed using the intent-to-treat principle so that comparisons were made according to the assigned intervention group regardless of study completion.||||0.09
72438602|NCT02755805|144390803|SUPERIORITY_OR_OTHER||Cohen's d effect size at month 6|1.23||||0.002|TWO_SIDED|||||a priori threshold set at p\<0.05|Mixed Models Analysis|F(2,34)=7.83|Effect size was calculated using mean change scores (baseline to month 6) and standard error of change (baseline to month 6) for each group.|All analyses were performed using the intent-to-treat principle so that comparisons were made according to assigned intervention group regardless of study completion.||||.002
72438603|NCT02755805|144390804|SUPERIORITY_OR_OTHER||Cohen's d effect size at month 6|0.7||||0.04|TWO_SIDED|||||a priori threshold set at \<0.05|repeated measures fixed effects model|F(2,28)=3.61|Effect size was calculated using mean change scores (baseline to month 6) and standard error of change (baseline to month 6) for each group.|All analyses were performed using the intent-to-treat principle so that comparisons were made according to the assigned intervention group regardless of study completion.||||.04
72438604|NCT02252042|144390818|SUPERIORITY||Hazard Ratio (HR)|0.82||||0.0316|TWO_SIDED|95.0|0.67|1.01|||Log Rank||Cox regression model with treatment as a covariate stratified by ECOG PS (0 vs. 1), HPV status (Positive vs. Negative) \& PD-L1 status (Strongly Positive, Not Strongly Positive)|||1.01|0.67|0.03160
72438605|NCT02252042|144390819|SUPERIORITY||Hazard Ratio (HR)|0.8||||0.01605|TWO_SIDED|95.0|0.65|0.98||Nominal p-value|Log Rank||Nominal HR. Cox regression model with treatment as a covariate stratified by ECOG PS (0 vs. 1), HPV status (Positive vs. Negative) \& PD-L1 status (Strongly Positive, Not Strongly Positive)|||0.98|0.65|0.01605
72438606|NCT02252042|144390820|SUPERIORITY||Hazard Ratio (HR)|0.74||||0.00493|TWO_SIDED|95.0|0.58|0.93|||Log Rank||Cox regression model with treatment as a covariate stratified by ECOG PS (0 vs. 1), HPV status (Positive vs. Negative) \& PD-L1 status (Strongly Positive, Not Strongly Positive)|||0.93|0.58|0.00493
72438607|NCT02252042|144390821|SUPERIORITY||Hazard Ratio (HR)|0.96||||0.32504|TWO_SIDED|95.0|0.79|1.16|||Log Rank||Cox regression model with treatment as a covariate stratified by ECOG PS (0 vs. 1), HPV status (Positive vs. Negative) \& PD-L1 status (Strongly Positive, Not Strongly Positive)|||1.16|0.79|0.32504
72438608|NCT02252042|144390822|SUPERIORITY||Hazard Ratio (HR)|0.86||||0.07736|TWO_SIDED|95.0|0.69|1.06|||Log Rank||Cox regression model with treatment as a single covariate|||1.06|0.69|0.07736
72438609|NCT02252042|144390823|SUPERIORITY||Difference in percentages|4.6||||0.061|TWO_SIDED|95.0|-1.2|10.6|||Log Rank|H0: difference in %=0; H1: difference in %\>0|Stratified by ECOG PS (0 vs. 1), HPV status (Positive vs. Negative) \& PD-L1 status (Strongly Positive, Not Strongly Positive)|||10.6|-1.2|0.0610
72438610|NCT02252042|144390824|SUPERIORITY||Difference in percentages|7.5||||0.0171|TWO_SIDED|95.0|0.6|14.6|||Log Rank|H0: difference in %=0; H1: difference in %\>0|Stratified by ECOG PS (0 vs. 1), HPV status (Positive vs. Negative) \& PD-L1 status (Strongly Positive, Not Strongly Positive)|||14.6|0.6|0.0171
72495352|NCT01920711|144519650|SUPERIORITY||Hazard Ratio (HR)|0.9295||||0.9588|TWO_SIDED|95.0|0.0581|14.861|||Cox's proportional hazards model|Treatment as fixed factor and stratified by region.||Renal Death||14.861|0.0581|0.9588
72558772|NCT02312154|144647525|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||The change in each of the biophysical parameters was calculated as the pretreatment value minus the posttreatment value for each visit, and these pre- vs posttreatment changes were used in the statistical analysis to minimize the intraindividual variation between the two cheeks. The Wilcoxon rank-sum test was performed to compare the week-by-week changes in parameters of the right and left cheeks (i.e., treated vs untreated).||||<0.05
72386149|NCT01313858|144280105|SUPERIORITY_OR_OTHER|||||||0.0059|||||||Repeated measures analysis|||Least squares mean difference from baseline in FFbH at Month 21 (Month 21 minus BL)||||0.0059
72386150|NCT01313858|144280105|SUPERIORITY_OR_OTHER|||||||0.0002|||||||Repeated measures analysis|||Least squares mean difference from baseline in FFbH at Month 24 (Month 24 minus BL)||||0.0002
72386151|NCT01313858|144280105|SUPERIORITY_OR_OTHER|||||||0.0002|||||||Repeated measures analysis|||Least squares mean difference from baseline in FFbH at Month 3 (Month 3 minus BL)||||0.0002
72386152|NCT01313858|144280105|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Repeated measures analysis|||Least squares mean difference from baseline in FFbH at Month 6 (Month 6 minus BL)||||<0.0001
72386153|NCT01313858|144280105|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Repeated measures analysis|||Least squares mean difference from baseline in FFbH at Month 9 (Month 9 minus BL)||||<0.0001
72386154|NCT01313858|144280105|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Repeated measures analysis|||Least squares mean difference from baseline in FFbH at Month 12 (Month 12 minus BL)||||<0.0001
72386155|NCT01313858|144280105|SUPERIORITY_OR_OTHER|||||||0.0002|||||||Repeated measures analysis|||Least squares mean difference from baseline in FFbH at Month 15 (Month 15 minus BL)||||0.0002
72386156|NCT01313858|144280105|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Repeated measures analysis|||Least squares mean difference from baseline in FFbH at Month 18 (Month 18 minus BL)||||<0.0001
72386157|NCT01313858|144280105|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Repeated measures analysis|||Least squares mean difference from baseline in FFbH at Month 21 (Month 21 minus BL)||||<0.0001
72386158|NCT01313858|144280105|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Repeated measures analysis|||Least squares mean difference from baseline in FFbH at Month 24 (Month 24 minus BL)||||<0.0001
72386159|NCT01313858|144280105|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Repeated measures analysis|||Least squares mean difference from baseline in FFbH at Month 3 (Month 3 minus BL)||||<0.0001
72386160|NCT01313858|144280105|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Repeated measures analysis|||Least squares mean difference from baseline in FFbH at Month 6 (Month 6 minus BL)||||<0.0001
72386161|NCT01313858|144280105|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Repeated measures analysis|||Least squares mean difference from baseline in FFbH at Month 9 (Month 9 minus BL)||||<0.0001
72386162|NCT01313858|144280105|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Repeated measures analysis|||Least squares mean difference from baseline in FFbH at Month 12 (Month 12 minus BL)||||<0.0001
72386163|NCT01313858|144280105|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Repeated measures analysis|||Least squares mean difference from baseline in FFbH at Month 15 (Month 15 minus BL)||||<0.0001
72386164|NCT01313858|144280105|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Repeated measures analysis|||Least squares mean difference from baseline in FFbH at Month 18 (Month 18 minus BL)||||<0.0001
72386165|NCT01313858|144280105|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Repeated measures analysis|||Least squares mean difference from baseline in FFbH at Month 21 (Month 21 minus BL)||||<0.0001
72386166|NCT01313858|144280105|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Repeated measures analysis|||Least squares mean difference from baseline in FFbH at Month 24 (Month 24 minus BL)||||<0.0001
72386167|NCT01313858|144280106|SUPERIORITY_OR_OTHER|||||||0.0003|||||||Repeated measures analysis|||Least squares mean difference from baseline in FACIT-F at Month 3 (Month 3 minus BL)||||0.0003
72386168|NCT01313858|144280106|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Repeated measures analysis|||Least squares mean difference from baseline in FACIT-F at Month 6 (Month 6 minus BL)||||<0.0001
72386169|NCT01313858|144280106|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Repeated measures analysis|||Least squares mean difference from baseline in FACIT-F at Month 12 (Month 12 minus BL)||||<0.0001
72386170|NCT01313858|144280106|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Repeated measures analysis|||Least squares mean difference from baseline in FACIT-F at Month 18 (Month 18 minus BL)||||<0.0001
72386171|NCT01313858|144280106|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Repeated measures analysis|||Least squares mean difference from baseline in FACIT-F at Month 24 (Month 24 minus BL)||||<0.0001
72386172|NCT01313858|144280106|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Repeated measures analysis|||Least squares mean difference from baseline in FACIT-F at Month 3 (Month 3 minus BL)||||<0.0001
72386173|NCT01313858|144280106|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Repeated measures analysis|||Least squares mean difference from baseline in FACIT-F at Month 6 (Month 6 minus BL)||||<0.0001
72386174|NCT01313858|144280106|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Repeated measures analysis|||Least squares mean difference from baseline in FACIT-F at Month 12 (Month 12 minus BL)||||<0.0001
72386175|NCT01313858|144280106|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Repeated measures analysis|||Least squares mean difference from baseline in FACIT-F at Month 18 (Month 18 minus BL)||||<0.0001
72386176|NCT01313858|144280106|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Repeated measures analysis|||Least squares mean difference from baseline in FACIT-F at Month 24 (Month 24 minus BL)||||<0.0001
72386177|NCT01313858|144280106|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Repeated measures analysis|||Least squares mean difference from baseline in FACIT-F at Month 3 (Month 3 minus BL)||||<0.0001
72386178|NCT01313858|144280106|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Repeated measures analysis|||Least squares mean difference from baseline in FACIT-F at Month 6 (Month 6 minus BL)||||<0.0001
72386179|NCT01313858|144280106|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Repeated measures analysis|||Least squares mean difference from baseline in FACIT-F at Month 12 (Month 12 minus BL)||||<0.0001
72438611|NCT02252042|144390827|SUPERIORITY||Hazard Ratio (HR)|0.89||||0.14545|TWO_SIDED|95.0|0.7|1.12||p-value stratified by ECOG PS (0 vs. 1), HPV status (Positive vs. Negative) \& PD-L1 status (Strongly Positive, Not Strongly Positive)|Log Rank||Cox regression model with treatment as a covariate stratified by ECOG PS (0 vs. 1), HPV status (Positive vs. Negative) \& PD-L1 status (Strongly Positive, Not Strongly Positive)|||1.12|0.70|0.14545
72438612|NCT02252042|144390828|SUPERIORITY||Hazard Ratio (HR)|0.81||||0.05851|TWO_SIDED|95.0|0.62|1.06||p-value stratified by ECOG PS (0 vs. 1), HPV status (Positive vs. Negative) \& PD-L1 status (Strongly Positive, Not Strongly Positive)|Log Rank||Cox regression model with treatment as a covariate stratified by ECOG PS (0 vs. 1), HPV status (Positive vs. Negative) \& PD-L1 status (Strongly Positive, Not Strongly Positive)|||1.06|0.62|0.05851
72438613|NCT02252042|144390829|SUPERIORITY||Hazard Ratio (HR)|1.04||||0.65759|TWO_SIDED|95.0|0.86|1.27|||Log Rank||Cox regression model with treatment as a covariate stratified by ECOG PS (0 vs. 1), HPV status (Positive vs. Negative) \& PD-L1 status (Strongly Positive, Not Strongly Positive)|||1.27|0.86|0.65759
72438614|NCT02252042|144390830|SUPERIORITY||Hazard Ratio (HR)|1.01||||0.51982|TWO_SIDED|95.0|0.81|1.26|||Log Rank||Cox regression model with treatment as a covariate stratified by ECOG PS (0 vs. 1), HPV status (Positive vs. Negative) \& PD-L1 status (Strongly Positive, Not Strongly Positive)|||1.26|0.81|0.51982
72438615|NCT00071799|144390836|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0001|TWO_SIDED|95.0|||||Log Rank|The p value is two-sided from the log rank test stratified by the randomization stratification factors of IPSS classification and FAB classification.||"A 95% CI range value of 'does not exist' is not accommodated in the results table, so all the 95% CI range values are offered here.~Azacitidine: low range of 17.9 months and high range of 'does not exist'.~Conventional Care: low range of 9.8 and high range of 17.0 months."||||0.0001
72438616|NCT00071799|144390836|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.58||||0.0002|TWO_SIDED|95.0|0.43|0.77|||Regression, Cox||Cox proportional hazards model stratified on the randomization factors of FAB and IPSS with model term of treatment.|||0.77|0.43|0.0002
72438617|NCT00071799|144390837|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3973||||||The p value is two-sided from the log rank test stratified by the randomization stratification factors of IPSS classification and FAB classification|Log Rank|||"Age \< 65 years The Kaplan-Meier median time to death was not reached due to a small number of events, so the KM 25th percentile survival time is presented.~Some of the values in outcome table #2 do not have 95% CI values so no 95% CI ranges are contained in the table. Those 95% CI ranges are added here.~Azacitidine: low range of 7.1 months and high range of 15.6 months.~Conventional Care: low range of 4.4 and high range of 12.4 months."||||0.3973
72438618|NCT00071799|144390837|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||The p value is two-sided from the log rank test stratified by the randomization stratification factors of IPSS classification and FAB classification|Log Rank|||"Age \>= 65 years~Some of the values in outcome table #2 do not have 95% CI values so no 95% CI ranges are contained in the table. Those 95% CI ranges are added here.~Azacitidine: low range of 17.1 months and high range of 34.7 months.~Conventional Care: low range of 8.8 and high range of 16.4 months."||||<0.0001
72438619|NCT00071799|144390837|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0707||||||The p value is two-sided from the log rank test stratified by the randomization stratification factors of IPSS classification and FAB classification|Log Rank|||"Age \>= 75 years. The Kaplan-Meier median time to death was not reached due to a small number of events, so the KM 25th percentile survival time is presented.~Some of the values in outcome table #2 do not have 95% CI values so no 95% CI ranges are contained in the table. Those 95% CI ranges are added here.~Azacitidine: low range of 1.7 months and high range of 15.0 months.~Conventional Care: low range of 4.1 and high range of 7.6 months."||||0.0707
72438620|NCT00071799|144390837|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0042||||||The p value is two-sided from the log rank test stratified by the randomization stratification factors of IPSS classification and FAB classification|Log Rank|||"Gender: Male~Some of the values in outcome table #2 do not have 95% CI values so no 95% CI ranges are contained in the table. Those 95% CI ranges are added here.~Azacitidine: low range of 17.9 months and high range of 'does not exist'.~Conventional Care: low range of 10.8 and high range of 17.2 months."||||0.0042
72438621|NCT00071799|144390837|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0469||||||The p value is two-sided from the log rank test stratified by the randomization stratification factors of IPSS classification and FAB classification|Log Rank|||"Gender: Female~Some of the values in outcome table #2 do not have 95% CI values so no 95% CI ranges are contained in the table. Those 95% CI ranges are added here.~Azacitidine: low range of 13.0 months and high range of 'does not exist'.~Conventional Care: low range of 8.2 and high range of 17.6 months."||||0.0469
72495353|NCT01920711|144519650|SUPERIORITY||Hazard Ratio (HR)|0.5774||||0.2484|TWO_SIDED|95.0|0.2272|1.4672|||Cox's proportional hazards model|Treatment as fixed factor and stratified by region.||Reaching ESRD||1.4672|0.2272|0.2484
72438622|NCT00071799|144390837|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0056||95.0||||"95% CI ranges are added here.~Azacitidine: low range of 21.1 months and high range of 'does not exist'.~Conventional Care: low range of 9.3 and high range of 21.9 months."|Log Rank|The p value is two-sided from the log rank test stratified by the randomization stratification factors of IPSS classification and FAB classification.||FAB: Refractory anemia with excess blasts (RAEB). All patients were stratified at randomization by FAB classification and IPSS score as determined by the investigator using centrally read bone marrow and cytogenetic data. Subsequently, the FAB classifications and IPSS scores were reviewed by an Independent Review Committee (IRC). The subgroup analyses presented by FAB and IPSS represent the FAB classification and IPSS scores as determined by the IRC.||||0.0056
72438623|NCT00071799|144390837|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0322||95.0||||The p value is two-sided from the log rank test stratified by the randomization stratification factors of IPSS classification and FAB classification|Log Rank|||"FAB: RAEB in transformation~Some of the values in outcome table #2 do not have 95% CI values so no 95% CI ranges are contained in the table. Those 95% CI ranges are added here.~Azacitidine: low range of 11.7 months and high range of 'does not exist'.~Conventional Care: low range of 9.4 and high range of 17.0 months."||||0.0322
72495354|NCT01920711|144519650|SUPERIORITY||Hazard Ratio (HR)|0.4407||||0.0004|TWO_SIDED|95.0|0.2798|0.6942|||Cox's proportional hazards model|Treatment as fixed factor and stratified by region.||\>=50% decline in eGFR from baseline||0.6942|0.2798|0.0004
72495355|NCT01920711|144519651|SUPERIORITY||Hazard Ratio (HR)|0.9696||||0.6846|TWO_SIDED|95.0|0.8352|1.1255|||Cox's proportional hazards model|Treatment as fixed factor and stratified by region.||All-cause mortality||1.1255|0.8352|0.6846
72495356|NCT01724528|144519682|SUPERIORITY_OR_OTHER||Least squares means difference|-196.794|||<|0.0001|TWO_SIDED|95.0|-238.6|-154.988|||ANCOVA|||Treatment, TLS risk (intermediate/high) and sUA level at baseline (≤ 7.5 mg/dL and \> 7.5 mg/dL) were inserted in the ANCOVA model as covariates||-154.988|-238.600|<0.0001
72495357|NCT01724528|144519683|SUPERIORITY_OR_OTHER||Least squares means difference|4.097||||0.0903|TWO_SIDED|95.0|-0.6467|8.8406|||ANCOVA|||Treatment, TLS risk (intermediate/high) and sUA level at baseline (≤ 7.5 mg/dL and \> 7.5 mg/dL) were inserted in the ANCOVA model as covariates||8.8406|-0.6467|0.0903
72495358|NCT01724528|144519684|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.0231||||0.1993|TWO_SIDED|95.0|-0.0153|0.0654|||Wilson's confidence interval|||||0.0654|-0.0153|0.1993
72386180|NCT01313858|144280106|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Repeated measures analysis|||Least squares mean difference from baseline in FACIT-F at Month 18 (Month 18 minus BL)||||<0.0001
72386181|NCT01313858|144280106|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Repeated measures analysis|||Least squares mean difference from baseline in FACIT-F at Month 24 (Month 24 minus BL)||||<0.0001
72386182|NCT01313858|144280107|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Repeated measures analysis|||Least squares mean difference from baseline in EQ-5D-3L at Month 6 (Month 6 minus BL)||||<0.0001
72386183|NCT01313858|144280107|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Repeated measures analysis|||Least squares mean difference from baseline in EQ-5D-3L at Month 12 (Month 12 minus BL)||||<0.0001
72386184|NCT01313858|144280107|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Repeated measures analysis|||Least squares mean difference from baseline in EQ-5D-3L at Month 18 (Month 18 minus BL)||||<0.0001
72386185|NCT01313858|144280107|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Repeated measures analysis|||Least squares mean difference from baseline in EQ-5D-3L at Month 24 (Month 24 minus BL)||||<0.0001
72386186|NCT01313858|144280107|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Repeated measures analysis|||Least squares mean difference from baseline in EQ-5D-3L at Month 6 (Month 6 minus BL)||||<0.0001
72386187|NCT01313858|144280107|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Repeated measures analysis|||Least squares mean difference from baseline in EQ-5D-3L at Month 12 (Month 12 minus BL)||||<0.0001
72386188|NCT01313858|144280107|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Repeated measures analysis|||Least squares mean difference from baseline in EQ-5D-3L at Month 18 (Month 18 minus BL)||||<0.0001
72386189|NCT01313858|144280107|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Repeated measures analysis|||Least squares mean difference from baseline in EQ-5D-3L at Month 24 (Month 24 minus BL)||||<0.0001
72386190|NCT01313858|144280107|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Repeated measures analysis|||Least squares mean difference from baseline in EQ-5D-3L at Month 6 (Month 6 minus BL)||||<0.0001
72386191|NCT01313858|144280107|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Repeated measures analysis|||Least squares mean difference from baseline in EQ-5D-3L at Month 12 (Month 12 minus BL)||||<0.0001
72386192|NCT01313858|144280107|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Repeated measures analysis|||Least squares mean difference from baseline in EQ-5D-3L at Month 18 (Month 18 minus BL)||||<0.0001
72386193|NCT01313858|144280107|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Repeated measures analysis|||Least squares mean difference from baseline in EQ-5D-3L at Month 24 (Month 24 minus BL)||||<0.0001
72386194|NCT03792191|144280121|SUPERIORITY||Median Difference (Final Values)|0.00007||||0.62|TWO_SIDED|95.0|-0.00005|1.0|||Wilcoxon (Mann-Whitney)|||||1|-0.00005|0.62
72386195|NCT03792191|144280122|SUPERIORITY|||||||0.58|||||||Wilcoxon (Mann-Whitney)|||||||0.58
72386196|NCT03792191|144280123|SUPERIORITY||Risk Difference (RD)|-0.036||||0.6|TWO_SIDED|95.0|-0.15|0.079|||Chi-squared, Corrected|||||0.079|-0.15|0.6
72386197|NCT03792191|144280124|SUPERIORITY||Risk Difference (RD)|-0.021||||0.77|TWO_SIDED|95.0|-0.125|0.082|||Chi-squared, Corrected|||||0.082|-0.125|0.77
72386198|NCT03792191|144280125|SUPERIORITY||Median Difference (Final Values)|8.0||||0.077|TWO_SIDED|95.0|-1.0|20.0|||Wilcoxon (Mann-Whitney)|||||20|-1|0.077
72386199|NCT03792191|144280126|SUPERIORITY||Median Difference (Final Values)|0.00003||||0.1|TWO_SIDED|95.0|-0.00001|0.00003|||Wilcoxon (Mann-Whitney)|||||0.00003|-0.00001|0.1
72386200|NCT03792191|144280127|SUPERIORITY||||||>|0.99|||||||Chi-squared, Corrected|||||||>0.99
72386201|NCT03792191|144280128|SUPERIORITY||||||>|0.99|||||||Chi-squared, Corrected|||||||>0.99
72386202|NCT03792191|144280130|SUPERIORITY||||||>|0.99|||||||Fisher Exact|||||||>0.99
72386203|NCT03917459|144280163|OTHER||LS mean of treatment difference|2.9|STANDARD_ERROR_OF_MEAN|2.94||0.3432|TWO_SIDED|95.0|-3.29|9.01|||Mixed Model Repeated Measures (MMRM)|||||9.01|-3.29|0.3432
72386204|NCT00491764|144280166|SUPERIORITY_OR_OTHER||Mean Difference (Net)|22.9||||0.005||95.0|8.9|36.8|||Fisher Exact||Difference is in the proportion for Yes responders. Confidence Interval is around the difference in proportions.|||36.8|8.9|0.005
72386205|NCT00491764|144280166|SUPERIORITY_OR_OTHER||Mean Difference (Net)|54.1|||<|0.001||95.0|38.0|70.1|||Fisher Exact||Difference is in the proportion for Yes responders. Confidence Interval is around the difference in proportions.|||70.1|38.0|<0.001
72386206|NCT00491764|144280166|SUPERIORITY_OR_OTHER||Mean Difference (Net)|45.5|||<|0.001||95.0|28.5|62.4|||Fisher Exact||Difference is in the proportion for Yes responders. Confidence Interval is around the difference in proportions.|||62.4|28.5|<0.001
72386207|NCT00491764|144280166|SUPERIORITY_OR_OTHER||Mean Difference (Net)|20.0||||0.012||95.0|6.7|33.3|||Fisher Exact||Difference is in the proportion for Yes responders. Confidence Interval is around the difference in proportions.|||33.3|6.7|0.012
72386208|NCT00491764|144280166|SUPERIORITY_OR_OTHER||Mean Difference (Net)|37.1|||<|0.001||95.0|21.1|53.2|||Fisher Exact||Difference is in the proportion for Yes responders. Confidence Interval is around the difference in proportions.|||53.2|21.1|<0.001
72386209|NCT00491764|144280167|SUPERIORITY_OR_OTHER||Mean Difference (Net)|25.7||||0.002||95.0|11.2|40.2|||Fisher Exact||Difference is in the proportion for Yes responders. Confidence Interval is around the difference in proportions.|||40.2|11.2|0.002
72386210|NCT00491764|144280167|SUPERIORITY_OR_OTHER||Mean Difference (Net)|64.9|||<|0.001||95.0|49.5|80.2|||Fisher Exact||Difference is in the proportion for Yes responders. Confidence Interval is around the difference in proportions.|||80.2|49.5|<0.001
72386211|NCT00491764|144280167|SUPERIORITY_OR_OTHER||Mean Difference (Net)|48.5|||<|0.001||95.0|31.4|65.5|||Fisher Exact||Difference is in the proportion for Yes responders. Confidence Interval is around the difference in proportions.|||65.5|31.4|<0.001
72386212|NCT00491764|144280167|SUPERIORITY_OR_OTHER||Mean Difference (Net)|31.4|||<|0.001||95.0|16.0|46.8|||Fisher Exact||Difference is in the proportion for Yes responders. Confidence Interval is around the difference in proportions.|||46.8|16.0|<0.001
72438624|NCT00071799|144390837|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1679||95.0||||The p value is two-sided from the log rank test stratified by the randomization stratification factors of IPSS classification and FAB classification|Log Rank|||"WHO: RAEB 1. The Kaplan-Meier median time to death was not reached due to a small number of events, so the KM 25th percentile survival time is presented.~Some of the values in outcome table #2 do not have 95% CI values so no 95% CI ranges are contained in the table. Those 95% CI ranges are added here.~Azacitidine: low range of 6.6 months and high range of 'does not exist'.~Conventional Care: low range of 1.8 and high range of 9.8 months."||||0.1679
72438625|NCT00071799|144390837|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0692||95.0||||The p value is two-sided from the log rank test stratified by the randomization stratification factors of IPSS classification and FAB classification|Log Rank|||"WHO: RAEB-2~Some of the values in outcome table #2 do not have 95% CI values so no 95% CI ranges are contained in the table. Those 95% CI ranges are added here.~Azacitidine: low range of 15.9 months and high range of 'does not exist'.~Conventional Care: low range of 8.8 and high range of 19.4 months."||||0.0692
72438626|NCT00071799|144390837|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0017||95.0||||The p value is two-sided from the log rank test stratified by the randomization stratification factors of IPSS classification and FAB classification|Log Rank|||"WHO: Other~Some of the values in outcome table #2 do not have 95% CI values so no 95% CI ranges are contained in the table. Those 95% CI ranges are added here.~Azacitidine: low range of 15.6 months and high range of 'does not exist'.~Conventional Care: low range of 11.1 and high range of 17.5 months."||||0.0017
72386213|NCT00491764|144280167|SUPERIORITY_OR_OTHER||Mean Difference (Net)|54.3|||<|0.001||95.0|37.8|70.8|||Fisher Exact||Difference is in the proportion for Yes responders. Confidence Interval is around the difference in proportions.|||70.8|37.8|<0.001
72386214|NCT00491764|144280168|SUPERIORITY_OR_OTHER||Mean Difference (Net)|31.4|||<|0.001||95.0|16.0|46.8|||Fisher Exact||Difference is in the proportion for Yes responders. Confidence Interval is around the difference in proportions.|||46.8|16.0|<0.001
72386215|NCT00491764|144280168|SUPERIORITY_OR_OTHER||Mean Difference (Net)|64.9|||<|0.001||95.0|49.5|80.2|||Fisher Exact||Difference is in the proportion for Yes responders. Confidence Interval is around the difference in proportions.|||80.2|49.5|<0.001
72386216|NCT00491764|144280168|SUPERIORITY_OR_OTHER||Mean Difference (Net)|66.7|||<|0.001||95.0|50.6|82.8|||Fisher Exact||Difference is in the proportion for Yes responders. Confidence Interval is around the difference in proportions.|||82.8|50.6|<0.001
72386217|NCT00491764|144280168|SUPERIORITY_OR_OTHER||Mean Difference (Net)|31.4|||<|0.001||95.0|16.0|46.8|||Fisher Exact||Difference is in the proportion for Yes responders. Confidence Interval is around the difference in proportions.|||46.8|16.0|<0.001
72386218|NCT00491764|144280168|SUPERIORITY_OR_OTHER||Mean Difference (Net)|57.1|||<|0.001||95.0|40.7|73.5|||Fisher Exact||Difference is in the proportion for Yes responders. Confidence Interval is around the difference in proportions.|||73.5|40.7|<0.001
72386219|NCT01479478|144280169|SUPERIORITY|||||||0.87|||||||Cochran-Mantel-Haenszel|||||||0.87
72386220|NCT01188421|144280202|SUPERIORITY||F-value for main effect of Group|1.31||||0.275|TWO_SIDED|||||Main effect of Group (e.g., Buprenorphine, Tramadol, Clonidine) on COWS Total Score Ratings|ANOVA|||A power analysis determined 40 participants in each group would detect a moderate effect size, assuming an alpha of 0.05 and 80% power. Due to the expiration of buprenorphine tablets, recruitment was terminated after enrolling 103 participants. This study utilized an Intent-to-Treat (ITT) analysis. The ITT analysis includes all volunteers who signed informed consent, were randomized into the study's treatment conditions, and took at least 1 dose of study medication.||||.275
72386221|NCT01188421|144280202|SUPERIORITY||F-value for main effect of Phase|3.57||||0.03|TWO_SIDED|||||Main effect for Phase (e.g., Stabilization, Taper, Post-Taper) on COWS total score.|ANOVA|||||||0.03
72386222|NCT01188421|144280202|SUPERIORITY||F-value for the main effect of Group x P|2.03||||0.092|TWO_SIDED|||||Main effect for Group x Phase interaction on COWS Total Score|ANOVA|||||||0.092
72386223|NCT00075218|144280203|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.329|||<|0.001||95.0|0.233|0.466||The nominal levels of significance for the interim and final analyses were determined at the time of the analyses using the Lan-DeMets procedure with an O'Brien-Fleming stopping rule.|Log Rank|two-sided unstratified log-rank test||The study was designed to test the null hypothesis that the median TTP from placebo treatment is 4 months versus the alternative hypothesis that the median TTP from sunitinib treatment is at least 6 months with an overall 2-sided significance level of 0.05 and power of 90%.||0.466|0.233|<0.001
72386224|NCT00075218|144280204|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.347|||<|0.001||95.0|0.253|0.475||No p-value adjustment for multiple comparisons.|Log Rank|||||0.475|0.253|<0.001
72386225|NCT00075218|144280206|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.876||||0.306||95.0|0.679|1.129||No p-value adjustment for multiple comparisons.|Log Rank|||||1.129|0.679|0.306
72386226|NCT00075218|144280207|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.505||||0.306||95.0|0.262|1.134||No p-value adjustment for multiple comparisons.|Rank Preserving Structural Failure Time||95% CI for Hazard Ratio is from 2.5% and 97.5% Empirical Percentiles of 100,000 Bootstraps.|||1.134|0.262|0.306
72386227|NCT00075218|144280209|SUPERIORITY_OR_OTHER||rate (percentage)|6.6||||||95.0|3.8|10.5|||||Used exact method based on binomial distribution.|||10.5|3.8|
72386228|NCT00075218|144280209|SUPERIORITY_OR_OTHER||Treatment Difference (%)|6.58||||0.004||95.0|3.47|9.7||No p-value adjustment for multiple comparisons.|Pearson chi-square test|||||9.70|3.47|0.004
72386229|NCT00075218|144280212|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.339|||<|0.001||95.0|0.244|0.472||two-sided unstratified log-rank test|Log Rank|||||0.472|0.244|<0.001
72495359|NCT01724528|144519685|SUPERIORITY_OR_OTHER||Relative risk|0.875||||0.8488|TWO_SIDED|95.0|0.4408|1.7369|||Chi-squared|||||1.7369|0.4408|0.8488
72495360|NCT01724528|144519686|SUPERIORITY_OR_OTHER||Relative risk|0.994||||1|TWO_SIDED|95.0|0.9691|1.0199|||Chi-squared|||||1.0199|0.9691|1.0000
72618885|NCT01260324|144768303|SUPERIORITY_OR_OTHER_LEGACY||Incidence rate per 1000 person-years|0.05|||||TWO_SIDED|95.0|0.04|0.05|||||Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.|Incidence rate Year 2005||0.05|0.04|
72386230|NCT00075218|144280212|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.327|||<|0.001||95.0|0.232|0.46|||Log Rank|log-rank test of treatment stratified by prior imatinib mesylate response and McGill Pain Questionnaire's Present Pain Intensity score||Stratified log-rank test||0.460|0.232|<0.001
72386231|NCT00075218|144280213|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.972||||0.9322||95.0|0.508|1.86|||Log Rank|2-sided, unstratified log-rank test||||1.860|0.508|0.9322
72495361|NCT00466310|144519688|SUPERIORITY_OR_OTHER|||||||0.0149|TWO_SIDED|95.0||||Unadjusted p value is .0041|Wilcoxon (Mann-Whitney)|||A wilcoxon rank sum test was performed comparing baseline plasmalogen values, comparing schizophrenia subjects vs controls.P values from this analysis were adjusted for false discovery rates by the method of Storey and Tribshiani.||||0.0149
72386232|NCT00075218|144280214|SUPERIORITY_OR_OTHER||Treatment Difference (percent)|17.3||||0.0046||95.0|6.7|28.0|||Pearson chi-square||95% CI of Difference based on normal distribution. Percent = (number of subjects with response per total subjects per treatment in defined analysis population)\*100.|||28.0|6.7|0.0046
72386233|NCT03840174|144280223|OTHER||GMT Ratio|77.7|||||TWO_SIDED|95.0|23.9|252.4|||||Geometric Mean Titer (GMT) ratio and 95% CI were estimated using an ANOVA model.|||252.4|23.9|
72386234|NCT00131508|144280236|SUPERIORITY_OR_OTHER|||||||0.17||95.0|||||Wilcoxon (Mann-Whitney)|||We tested for a significant difference in the median change in REE ratio between the placebo and glutamine groups. The study was designed to provide 80% power at an alpha level of 0.05 for this objective. Due to slow accrual, the sample size of 46 participants required to obtain the designed power of the study was not realized.||||0.17
72386235|NCT00131508|144280237|SUPERIORITY_OR_OTHER|||||||0.53||95.0|||||Wilcoxon (Mann-Whitney)|||We tested for a significant difference in the median change of body mass index between the placebo and glutamine groups.||||0.53
72386236|NCT00131508|144280238|SUPERIORITY_OR_OTHER|||||||0.24||95.0|||||Wilcoxon (Mann-Whitney)|||We tested for a significant difference in the median change in red blood cell glutamine between the placebo and glutamine groups.||||0.24
72386237|NCT00131508|144280239|SUPERIORITY_OR_OTHER|||||||0.62||95.0|||||Wilcoxon (Mann-Whitney)|||We tested for a significant difference in the median change between baseline parent reported physical function in the placebo and glutamine groups.||||0.62
72386238|NCT00131508|144280239|SUPERIORITY_OR_OTHER|||||||0.14||95.0|||||Wilcoxon (Mann-Whitney)|||We tested for a significant difference in the median change between baseline parent reported emotional function in the placebo and glutamine groups.||||0.14
72386239|NCT00131508|144280239|SUPERIORITY_OR_OTHER|||||||0.2||95.0|||||Wilcoxon (Mann-Whitney)|||We tested for a significant difference in the median change between baseline parent reported social function in the placebo and glutamine groups.||||0.20
72386240|NCT00131508|144280239|SUPERIORITY_OR_OTHER|||||||0.62||95.0|||||Wilcoxon (Mann-Whitney)|||We tested for a significant difference in the median change between baseline parent reported school function in the placebo and glutamine groups.||||0.62
72386241|NCT00131508|144280239|SUPERIORITY_OR_OTHER|||||||0.61||95.0|||||Wilcoxon (Mann-Whitney)|||We tested for a significant difference in the median change between 12 month parent reported physical function in the placebo and glutamine groups.||||0.61
72386242|NCT00131508|144280239|SUPERIORITY_OR_OTHER|||||||0.65||95.0|||||Wilcoxon (Mann-Whitney)|||We tested for a significant difference in the median change between 12 month parent reported emotional function in the placebo and glutamine groups.||||0.65
72386243|NCT00131508|144280239|SUPERIORITY_OR_OTHER|||||||0.55||95.0|||||Wilcoxon (Mann-Whitney)|||We tested for a significant difference in the median change between 12 month parent reported social function in the placebo and glutamine groups.||||0.55
72386244|NCT00131508|144280239|SUPERIORITY_OR_OTHER|||||||0.69||95.0|||||Wilcoxon (Mann-Whitney)|||We tested for a significant difference in the median change between 12 month parent reported school function in the placebo and glutamine groups.||||0.69
72386245|NCT00131508|144280239|SUPERIORITY_OR_OTHER|||||||0.82||95.0|||||Wilcoxon (Mann-Whitney)|||We tested for a significant difference in the median change between baseline patient reported physical function in the placebo and glutamine groups.||||0.82
72386246|NCT00131508|144280239|SUPERIORITY_OR_OTHER|||||||0.99||95.0|||||Wilcoxon (Mann-Whitney)|||We tested for a significant difference in the median change between baseline patient reported emotional function in the placebo and glutamine groups.||||0.99
72386247|NCT00131508|144280239|SUPERIORITY_OR_OTHER|||||||0.3||95.0|||||Wilcoxon (Mann-Whitney)|||We tested for a significant difference in the median change between baseline patient reported social function in the placebo and glutamine groups.||||0.30
72386248|NCT00131508|144280239|SUPERIORITY_OR_OTHER|||||||0.24||95.0|||||Wilcoxon (Mann-Whitney)|||We tested for a significant difference in the median change between baseline patient reported school function in the placebo and glutamine groups.||||0.24
72386249|NCT00131508|144280239|SUPERIORITY_OR_OTHER|||||||0.5||95.0|||||Wilcoxon (Mann-Whitney)|||We tested for a significant difference in the median change between 12 month patient reported physical function in the placebo and glutamine groups.||||0.50
72386250|NCT00131508|144280239|SUPERIORITY_OR_OTHER|||||||0.45||95.0|||||Wilcoxon (Mann-Whitney)|||We tested for a significant difference in the median change between 12 month patient reported emotional function in the placebo and glutamine groups.||||0.45
72386251|NCT00131508|144280239|SUPERIORITY_OR_OTHER|||||||0.46||95.0|||||Wilcoxon (Mann-Whitney)|||We tested for a significant difference in the median change between 12 month patient reported social function in the placebo and glutamine groups.||||0.46
72386252|NCT00131508|144280239|SUPERIORITY_OR_OTHER|||||||0.84||95.0|||||Wilcoxon (Mann-Whitney)|||We tested for a significant difference in the median change between 12 month patient reported school function in the placebo and glutamine groups.||||0.84
72386253|NCT00131508|144280240|SUPERIORITY_OR_OTHER|||||||0.2||95.0|||||Wilcoxon Signed Rank Test|||We tested the null hypothesis that the median difference in height Z-Score betweeen baseline and 12 months is equal to zero versus the alternative hypothesis that the difference is not zero.||||0.20
72386254|NCT00131508|144280240|SUPERIORITY_OR_OTHER|||||||0.81||95.0|||||Wilcoxon Signed Rank Test|||We tested the null hypothesis that the median difference in height Z-Score betweeen baseline and 12 months is equal to zero versus the alternative hypothesis that the difference is not zero.||||0.81
72386255|NCT00131508|144280240|SUPERIORITY_OR_OTHER|||||||0.7||95.0|||||Wilcoxon (Mann-Whitney)|||We tested the null hypothesis that the median difference in height Z-Score betweeen baseline and 12 months differs between the Glutamine and Placebo groups.||||0.70
72386256|NCT00131508|144280241|SUPERIORITY_OR_OTHER|||||||0.69||95.0|||||Wilcoxon Signed Rank Test|||We tested the null hypothesis that the median difference in height percentile between baseline and 12 months is equal to zero versus the alternative hypothesis that the difference is not zero.||||0.69
72495362|NCT01634555|144519691|SUPERIORITY_OR_OTHER||Ratio of Geo LS means|0.93|||||TWO_SIDED|90.0|0.83|1.05|||Mixed Models Analysis|Ratio of Geo LS mean is AUC(0-∞) of Cycle 2/Cycle 1 for Irinotecan .||||1.05|0.83|
72558773|NCT02312154|144647526|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||The change in each of the biophysical parameters was calculated as the pretreatment value minus the posttreatment value for each visit, and these pre- vs posttreatment changes were used in the statistical analysis to minimize the intraindividual variation between the two cheeks. The Wilcoxon rank-sum test was performed to compare the week-by-week changes in parameters of the right and left cheeks (i.e., treated vs untreated).||||<0.05
72558774|NCT02312154|144647527|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||The change in each of the biophysical parameters was calculated as the pretreatment value minus the posttreatment value for each visit, and these pre- vs posttreatment changes were used in the statistical analysis to minimize the intraindividual variation between the two cheeks. The Wilcoxon rank-sum test was performed to compare the week-by-week changes in parameters of the right and left cheeks (i.e., treated vs untreated).||||<0.05
72618886|NCT01260324|144768303|SUPERIORITY_OR_OTHER_LEGACY||Incidence rate per 1000 person-years|0.04|||||TWO_SIDED|95.0|0.04|0.05|||||Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.|Incidence rate Year 2006||0.05|0.04|
72386257|NCT00131508|144280241|SUPERIORITY_OR_OTHER|||||||0.75||95.0|||||Wilcoxon Signed Rank Test|||We tested the null hypothesis that the median difference in height percentile between baseline and 12 months is equal to zero versus the alternative hypothesis that the difference is not zero.||||0.75
72386258|NCT00131508|144280241|SUPERIORITY_OR_OTHER|||||||0.93||95.0|||||Wilcoxon (Mann-Whitney)|||We test the null hypothesis that the median difference in height percentile between baseline and 12 months differs between the Glutamine and Placebo groups.||||0.93
72386259|NCT00131508|144280242|SUPERIORITY_OR_OTHER|||||||0.56||95.0|||||Wilcoxon Signed Rank Test|||We tested the null hypothesis that the median difference in weight percentile between baseline and 12 months is equal to zero versus the alternative hypothesis that the difference is not zero.||||0.56
72438627|NCT00071799|144390837|SUPERIORITY_OR_OTHER_LEGACY|||||||0.103||95.0||||"95% CI ranges are added here.~Azacitidine: low range of 17.1 months and high range of 'does not exist'.~Conventional Care: low range of 8.7 and high range of 24.1 months."|Log Rank|The p value is two-sided from the log rank test stratified by the randomization stratification factors of IPSS classification and FAB classification.||IPSS: Intermediate 2 All patients were stratified at randomization by FAB classification and IPSS score as determined by the investigator using centrally read bone marrow and cytogenetic data. Subsequently, the FAB classifications and IPSS scores were reviewed by an Independent Review Committee (IRC). The subgroup analyses presented by FAB and IPSS represent the FAB classification and IPSS scores as determined by the IRC.||||0.1030
72386260|NCT00131508|144280242|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Wilcoxon Signed Rank Test|||We tested the null hypothesis that the median difference in weight percentile between baseline and 12 months is equal to zero versus the alternative hypothesis that the difference is not zero.||||1.0
72438628|NCT00071799|144390837|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002||95.0||||"95% CI ranges are added here.~Azacitidine: low range of 15.0 months and high range of 'does not exist'.~Conventional Care: low range of 9.0 and high range of 17.0 months."|Log Rank|The p value is two-sided from the log rank test stratified by the randomization stratification factors of IPSS classification and FAB classification||IPSS: High All patients were stratified at randomization by FAB classification and IPSS score as determined by the investigator using centrally read bone marrow and cytogenetic data. Subsequently, the FAB classifications and IPSS scores were reviewed by an Independent Review Committee (IRC). The subgroup analyses presented by FAB and IPSS represent the FAB classification and IPSS scores as determined by the IRC.||||0.0020
72438629|NCT00071799|144390838|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0025||95.0||||The p value is two-sided from the log rank test stratified by the randomization stratification factors of IPSS classification and FAB classification.|Log Rank|||||||0.0025
72438630|NCT00071799|144390838|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.68||||0.0027|TWO_SIDED|95.0|0.53|0.87|||Regression, Cox||Cox proportional hazards model stratified on the randomization factors of FAB and IPSS with model term of treatment.|||0.87|0.53|0.0027
72438631|NCT00071799|144390839|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2555||95.0||||The p value is two-sided from the log rank test stratified by the randomization stratification factors of IPSS classification and FAB classification|Log Rank|||||||0.2555
72438632|NCT00071799|144390839|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.83||||0.2562|TWO_SIDED|95.0|0.6|1.15|||Regression, Cox||Cox proportional hazards model stratified on the randomization factors of FAB and IPSS with model term of treatment.|||1.15|0.60|0.2562
72438633|NCT00071799|144390840|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||Fisher Exact|||The p value is from Fisher's exact test comparing the difference in the azacitidine group and the combined group of CCR regimens among patients who were transfusion dependent at baseline and transfusion independent during the on-treatment period.||||<0.0001
72438634|NCT00071799|144390841|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0005||95.0|||||Fisher Exact|||The p value is from Fisher's exact test comparing the difference in the azacitidine group and the combined group of CCR regimens among patients who were transfusion independent at baseline and remained transfusion independent during the on-treatment period.||||0.0005
72495363|NCT01634555|144519691|SUPERIORITY_OR_OTHER||Ratio of Geo LS means|0.95|||||TWO_SIDED|90.0|0.88|1.04|||Mixed Models Analysis|Ratio of Geo LS mean is AUC(0-∞) of Cycle 2/Cycle 1 for Metabolite SN-38.||||1.04|0.88|
72386261|NCT00131508|144280242|SUPERIORITY_OR_OTHER|||||||0.61||95.0|||||Wilcoxon (Mann-Whitney)|||We test the null hypothesis that the median difference in weight percentile between baseline and 12 months differs between the Glutamine and Placebo groups.||||0.61
72386262|NCT00131508|144280243|SUPERIORITY_OR_OTHER|||||||0.83||95.0|||||Wilcoxon (Mann-Whitney)|||We tested for a significant difference in the median change in pulse rate between the placebo and glutamine groups.||||0.83
72386263|NCT00131508|144280244|SUPERIORITY_OR_OTHER|||||||0.4||95.0|||||Wilcoxon (Mann-Whitney)|||We tested for a significant difference in the median change in hand grip between the placebo and glutamine groups.||||0.40
72438635|NCT00071799|144390842|SUPERIORITY_OR_OTHER_LEGACY|||||||1||95.0|||||Fisher Exact|||The p value is from Fisher's exact test comparing the difference in the azacitidine group and the combined group of CCR regimens among patients who were transfusion dependent at baseline and transfusion independent during the on-treatment period||||1.000
72495364|NCT01634555|144519693|SUPERIORITY_OR_OTHER||Ratio of Geo LS means|1.04|||||TWO_SIDED|90.0|0.97|1.12|||Mixed Models Analysis|Ratio of Geo LS mean is Cmax of Cycle 2/Cycle 1 for Irinotecan.||||1.12|0.97|
72386264|NCT04269707|144280245|NON_INFERIORITY|Change in hemoglobin from baseline to day 35 was assessed using paired t-tests (two-sided test, alpha = 0.05).|Mean Difference (Final Values)|0.7||||0.1711|TWO_SIDED|95.0|-0.4|1.8|||t-test, 2 sided|||||1.80|-0.40|0.1711
72386265|NCT05047770|144280250|NON_INFERIORITY|The non-inferiority was to be concluded if the upper limit (UL) of the 95% confidence interval (CI) of the adjusted GMC ratio between HZ/suSeq group and HZ/suCoAd group for anti-gE antibody concentration was below (\<) 1.5.|GMC Ratio|1.01|||||TWO_SIDED|95.0|0.89|1.13|||ANCOVA|||To demonstrate the non-inferiority of humoral immunogenicity of 2 doses of HZ/su vaccine when the first dose of HZ/su vaccine was co-administered with the mRNA-1273 booster dose compared to HZ/su vaccine administered alone, in terms of anti-gE GMCs, at 1 month post-dose 2 of HZ/su vaccine administration (Week 14 for HZ/suSeq group and Week 12 for HZ/suCoAd group).||1.13|0.89|
72386266|NCT05047770|144280251|NON_INFERIORITY|The non-inferiority was to be concluded if the UL of the 95% CI of the adjusted GMC ratio between HZ/suSeq group and HZ/suCoAd group for anti-S protein antibody concentration was \<1.5.|GMC Ratio|1.09|||||TWO_SIDED|95.0|0.9|1.32|||ANCOVA|||To demonstrate the non-inferiority of humoral immunogenicity of 1 dose of mRNA-1273 booster when the first dose of HZ/su vaccine was co-administered with the mRNA-1273 booster dose compared to mRNA-1273 booster dose administered alone, in terms of anti-S protein GMCs, at 1 month post-mRNA-1273 booster dose administration (at Week 4 for both HZ/suSeq and HZ/suCoAd groups).||1.32|0.90|
72386267|NCT05047770|144280252|NON_INFERIORITY|The non-inferiority was to be concluded if the UL of the 95% CI of the adjusted GMT ratio between FluD-QIVSeq group and FluD-QIVCoAd group for anti-HI antibody titer was \<1.5 for the A/H1N1 influenza strain.|GMT Ratio|1.02|||||TWO_SIDED|95.0|0.89|1.18|||ANCOVA|||To demonstrate the non-inferiority of humoral immunogenicity of 1 dose of Flu D-QIV vaccine when co-administered with mRNA-1273 booster dose compared to Flu D-QIV vaccine administered alone, in terms of anti-HI GMTs against the A/H1N1 influenza strain included in the Flu D-QIV vaccine, at 1 month post-Flu D-QIV vaccine dose administration (Week 6 for FluD-QIVSeq group and Week 4 for FluD-QIVCoAd group).||1.18|0.89|
72386268|NCT05047770|144280252|NON_INFERIORITY|The non-inferiority was to be concluded if the UL of the 95% CI of the adjusted GMT ratio between FluD-QIVSeq group and FluD-QIVCoAd group for anti-HI antibody titer was \<1.5 for the A/H3N2 influenza strain.|GMT Ratio|0.93|||||TWO_SIDED|95.0|0.82|1.05|||ANCOVA|||To demonstrate the non-inferiority of humoral immunogenicity of 1 dose of Flu D-QIV vaccine when co-administered with mRNA-1273 booster dose compared to Flu D-QIV vaccine administered alone, in terms of anti-HI GMTs against the A/H3N2 influenza strain included in the Flu D-QIV vaccine, at 1 month post-Flu D-QIV vaccine dose administration (Week 6 for FluD-QIVSeq group and Week 4 for FluD-QIVCoAd group).||1.05|0.82|
72386269|NCT05047770|144280252|NON_INFERIORITY|The non-inferiority was to be concluded if the UL of the 95% CI of the adjusted GMT ratio between FluD-QIVSeq group and FluD-QIVCoAd group for anti-HI antibody titer was \<1.5 for the B/Victoria lineage influenza strain.|GMT Ratio|1.0|||||TWO_SIDED|95.0|0.89|1.14|||ANCOVA|||To demonstrate the non-inferiority of humoral immunogenicity of 1 dose of Flu D-QIV vaccine when co-administered with mRNA-1273 booster dose compared to Flu D-QIV vaccine administered alone, in terms of anti-HI GMTs against the B/Victoria lineage influenza strain included in the Flu D-QIV vaccine, at 1 month post-Flu D-QIV vaccine dose administration (Week 6 for FluD-QIVSeq group and Week 4 for FluD-QIVCoAd group).||1.14|0.89|
72386270|NCT05047770|144280252|NON_INFERIORITY|The non-inferiority was to be concluded if the UL of the 95% CI of the adjusted GMT ratio between FluD-QIVSeq group and FluD-QIVCoAd group for anti-HI antibody titer was \<1.5 for the B/Yamagata lineage influenza strain.|GMT Ratio|1.04|||||TWO_SIDED|95.0|0.93|1.17|||ANCOVA|||To demonstrate the non-inferiority of humoral immunogenicity of 1 dose of Flu D-QIV vaccine when co-administered with mRNA-1273 booster dose compared to Flu D-QIV vaccine administered alone, in terms of anti-HI GMTs against the B/Yamagata lineage influenza strain included in the Flu D-QIV vaccine, at 1 month post-Flu D-QIV vaccine dose administration (Week 6 for FluD-QIVSeq group and Week 4 for FluD-QIVCoAd group).||1.17|0.93|
72386271|NCT05047770|144280253|NON_INFERIORITY|The non-inferiority was to be concluded if the UL of the 95% CI of the adjusted GMC ratio between FluD-QIVSeq group and FluD-QIVCoAd group for anti-S antibody concentration was \<1.5.|GMC Ratio|0.98|||||TWO_SIDED|95.0|0.84|1.13|||ANCOVA|||To demonstrate the non-inferiority of humoral immunogenicity of 1 dose of mRNA-1273 booster when co-administered with Flu D-QIV vaccine compared to mRNA-1273 booster dose administered alone in terms of anti-S protein GMCs, at 1 month post-mRNA-1273 booster dose administration (at Week 4 for both FluD-QIVSeq and FluD-QIVCoAd groups).||1.13|0.84|
72386272|NCT05047770|144280254|NON_INFERIORITY|The non-inferiority was to be concluded if the UL of the 95% CI of the difference in percentage of participants seroconverted for anti-HI antibodies against the A/H1N1 influenza strain between FluD-QIVSeq group and FluD-QIVCoAd group was \< 10%.|Difference in percentage|0.6|||||TWO_SIDED|95.0|-5.1|6.4|||ANCOVA|||To demonstrate the non-inferiority of humoral immunogenicity of 1 dose of Flu D-QIV vaccine when co-administered with mRNA-1273 booster dose compared to Flu D-QIV vaccine administered alone, in terms of percentage of participants seroconverted for anti-HI antibodies against the A/H1N1 influenza strain included in the Flu D-QIV vaccine, at 1 month post-Flu D-QIV vaccine dose administration (Week 6 for FluD-QIVSeq group and Week 4 for FluD-QIVCoAd group).||6.4|-5.1|
72386273|NCT05047770|144280254|NON_INFERIORITY|The non-inferiority was to be concluded if the UL of the 95% CI of the difference in percentage of participants seroconverted for anti-HI antibodies against the A/H3N2 influenza strain between FluD-QIVSeq group and FluD-QIVCoAd group was \< 10%.|Difference in percentage|-1.3|||||TWO_SIDED|95.0|-7.8|5.2|||ANCOVA|||To demonstrate the non-inferiority of humoral immunogenicity of 1 dose of Flu D-QIV vaccine when co-administered with mRNA-1273 booster dose compared to Flu D-QIV vaccine administered alone, in terms of percentage of participants seroconverted for anti-HI antibodies against the A/H3N2 influenza strain included in the Flu D-QIV vaccine, at 1 month post-Flu D-QIV vaccine dose administration (Week 6 for FluD-QIVSeq group and Week 4 for FluD-QIVCoAd group).||5.2|-7.8|
72395145|NCT02730455|144296814|SUPERIORITY||Adjusted Mean Difference|-0.7||||0.542|TWO_SIDED|95.0|-2.96|1.56|||Mixed-effects model for repeated measure|||Treatment and treatment by visit interaction were included in the model as explanatory variables. Baseline NIHSS category (score 5-15, 16-23), tPA use (yes/no), age (\<60, 60-69, 70-80), thrombectomy (yes/no), region (Spain, UK/Germany, USA) and treatment window were considered as covariates. An unstructured variance-covariance matrix was used in the model.||1.56|-2.96|0.542
72495365|NCT01634555|144519693|SUPERIORITY_OR_OTHER||Ratio of Geo LS means|0.97|||||TWO_SIDED|90.0|0.85|1.12|||Mixed Models Analysis|Ratio of Geo LS mean is Cmax of Cycle 2/Cycle 1 for Metabolite SN-38.||||1.12|0.85|
72495366|NCT01299766|144519742|SUPERIORITY||Risk Ratio (RR)|0.12||||0.02|TWO_SIDED|95.0|0.02|0.74|||Poisson regression with robust SE (GEE)|||Poisson regression with robust standard errors (GEE) was used to jointly model decline in HVLT-R Total Recall score ≥ 6 words at 6, 12, 18, and 24 months by treatment group. The model included time, treatment, time-by-treatment interaction terms, and baseline HVLT-R Total Recall score.||0.74|0.02|.02
72495367|NCT01299766|144519743|SUPERIORITY||Difference in Slopes|2.47||||0.064|TWO_SIDED|95.0|-0.14|5.07|||Mixed Models Analysis|||Mixed effects linear regression was used to model the trajectory. Fixed effects for time (as a continuous variable), treatment group, time-by-treatment group interaction, and age at baseline were included. Random intercepts and slopes were included to account for within-subject correlation.||5.07|-.14|.064
72504638|NCT02495077|144540064|SUPERIORITY||Mean Difference (Final Values)|-4.9||||0.099|TWO_SIDED|95.0|-10.73|0.93|||Mixed Models Analysis|||Mean eGFR of the two treatment groups was compared. The p-value, estimated month 24 eGFR within each treatment group, estimate of the treatment group difference, and estimated 95% confidence intervals result from a repeated measures mixed model using available eGFR data from months 1, 3, 6, 12, 18, and 24 to compare the experimental group to the control group. Random effects for the intercept and eGFR collection day were utilized in the model.||0.93|-10.73|0.099
72504639|NCT02495077|144540065|SUPERIORITY||||||>|0.999|||||||Fisher Exact|||||||>0.999
72618887|NCT01260324|144768303|SUPERIORITY_OR_OTHER_LEGACY||Incidence rate per 1000 person-years|0.05|||||TWO_SIDED|95.0|0.04|0.05|||||Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.|Incidence rate Year 2007||0.05|0.04|
72386274|NCT05047770|144280254|NON_INFERIORITY|The non-inferiority was to be concluded if the UL of the 95% CI of the difference in percentage of participants seroconverted for anti-HI antibodies against the B/Victoria lineage influenza strain between FluD-QIVSeq group and FluD-QIVCoAd group was \< 10%.|Difference in percentage|0.1|||||TWO_SIDED|95.0|-5.8|5.9|||ANCOVA|||To demonstrate the non-inferiority of humoral immunogenicity of 1 dose of Flu D-QIV vaccine when co-administered with mRNA-1273 booster dose compared to Flu D-QIV vaccine administered alone, in terms of percentage of participants seroconverted for anti-HI antibodies against the B/Victoria lineage influenza strain included in the Flu D-QIV vaccine, at 1 month post-Flu D-QIV vaccine dose administration (Week 6 for FluD-QIVSeq group and Week 4 for FluD-QIVCoAd group).||5.9|-5.8|
72386275|NCT05047770|144280254|NON_INFERIORITY|The non-inferiority was to be concluded if the UL of the 95% CI of the difference in percentage of participants seroconverted for anti-HI antibodies against the B/Yamagata influenza strain between FluD-QIVSeq group and FluD-QIVCoAd group was \< 10%.|Difference in percentage|-1.6|||||TWO_SIDED|95.0|-7.0|3.9|||ANCOVA|||To demonstrate the non-inferiority of humoral immunogenicity of 1 dose of Flu D-QIV vaccine when co-administered with mRNA-1273 booster dose compared to Flu D-QIV vaccine administered alone, in terms of percentage of participants seroconverted for anti-HI antibodies against the B/Yamagata influenza strain included in the Flu D-QIV vaccine, at 1 month post-Flu D-QIV vaccine dose administration (Week 6 for FluD-QIVSeq group and Week 4 for FluD-QIVCoAd group).||3.9|-7.0|
72386276|NCT03758443|144280289|SUPERIORITY||Least Square Mean Difference|-0.27||||0.5809|TWO_SIDED|95.0|-1.22|0.69|||ANCOVA|||Least square estimates, 95% CI, and p-values were obtained by fitting an ANCOVA model with terms for treatment, steroid use at baseline (yes, no) and prior biologic failure (yes, no), and baseline total Mayo score as covariate.||0.69|-1.22|0.5809
72386277|NCT03758443|144280289|SUPERIORITY||Least Square Mean Difference|-0.37||||0.4501|TWO_SIDED|95.0|-1.33|0.59|||ANCOVA|||Least square estimates, 95% CI, and p-values were obtained by fitting an ANCOVA model with terms for treatment, steroid use at baseline (yes, no) and prior biologic failure (yes, no), and baseline total Mayo score as covariate.||0.59|-1.33|0.4501
72386278|NCT03758443|144280289|SUPERIORITY||Least Square Mean Difference|-0.65||||0.1809|TWO_SIDED|95.0|-1.6|0.3|||ANCOVA|||Least square estimates, 95% CI, and p-values were obtained by fitting an ANCOVA model with terms for treatment, steroid use at baseline (yes, no) and prior biologic failure (yes, no), and baseline total Mayo score as covariate.||0.30|-1.60|0.1809
72386279|NCT03758443|144280290|SUPERIORITY|||||||0.3762|||||||Fisher Exact|||||||0.3762
72386280|NCT03758443|144280290|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.0000
72386281|NCT03758443|144280290|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.0000
72386282|NCT03758443|144280291|SUPERIORITY||Difference in Proportion|0.0||||0.9542|TWO_SIDED|95.0|-0.104|0.11||P-value is shown for Cochran-Mantel Haenszel tests stratified by prior biologic failure and steroid use at baseline.|Cochran-Mantel-Haenszel||Difference in proportion estimates used Mantel-Haenszel stratum weights.|||0.110|-0.104|0.9542
72386283|NCT03758443|144280291|SUPERIORITY||Difference in Proportion|-0.03||||0.5863|TWO_SIDED|95.0|-0.126|0.071||P-value is shown for Cochran-Mantel Haenszel tests stratified by prior biologic failure and steroid use at baseline.|Cochran-Mantel-Haenszel||Difference in proportion estimates used Mantel-Haenszel stratum weights.|||0.071|-0.126|0.5863
72386284|NCT03758443|144280291|SUPERIORITY||Difference in Proportion|-0.03||||0.5408|TWO_SIDED|95.0|-0.131|0.069||P-value is shown for Conhran-Mantel Haenszel tests stratified by prior biologic failure and steroid use at baseline.|Cochran-Mantel-Haenszel||Difference in proportion estimates used Mantel-Haenszel stratum weights.|||0.069|-0.131|0.5408
72386285|NCT03758443|144280292|SUPERIORITY|||||||0.6656|||||||Fisher Exact|||||||0.6656
72386286|NCT03758443|144280292|SUPERIORITY|||||||0.6424|||||||Fisher Exact|||||||0.6424
72386287|NCT03758443|144280292|SUPERIORITY|||||||0.6199|||||||Fisher Exact|||||||0.6199
72386288|NCT03758443|144280293|SUPERIORITY|||||||0.2643|||||||Fisher Exact|||||||0.2643
72504640|NCT02495077|144540066|SUPERIORITY||||||>|0.999|||||||Fisher Exact|||||||>0.999
72504641|NCT02495077|144540068|SUPERIORITY|||||||0.746|||||||Fisher Exact|||||||0.746
72504642|NCT02495077|144540069|SUPERIORITY|||||||0.242|||||||Chi-squared|||||||0.242
72504643|NCT02495077|144540071|SUPERIORITY||||||>|0.999|||||||Fisher Exact|||||||>0.999
72386289|NCT03758443|144280293|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.0000
72386290|NCT03758443|144280293|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.0000
72386291|NCT03758443|144280294|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.0000
72386292|NCT03758443|144280294|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.0000
72386293|NCT03758443|144280294|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.0000
72395146|NCT02730455|144296817|SUPERIORITY|||||||0.028|||||||Cochran-Armitage trend test|||"mRS: The Cochran-Armitage trend test of a monotonically increasing dose response in proportion of excellent outcome.~Dose levels are log transformed."||||0.028
72618888|NCT01260324|144768303|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.77|||||TWO_SIDED|95.0|0.61|0.96|||||Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.|Odds ratio Year 2004||0.96|0.61|
72438636|NCT00071799|144390843|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||Fisher Exact|||The p value is from Fisher's exact test comparing the difference in the azacitidine group and the combined group of CCR regimens among patients who were transfusion independent at baseline and remained transfusion independent during the on-treatment period.||||<0.0001
72438637|NCT00071799|144390844|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0001||95.0|||||Fisher Exact|||Overall (Complete + Partial Remission)||||0.0001
72438638|NCT00071799|144390844|SUPERIORITY_OR_OTHER_LEGACY|||||||0.015||95.0|||||Fisher Exact|||Complete remission||||0.0150
72438639|NCT00071799|144390844|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0094||95.0|||||Fisher Exact|||Partial Remission||||0.0094
72438640|NCT00071799|144390844|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3297||95.0|||||Fisher Exact|||Stable Disease||||0.3297
72438641|NCT00071799|144390845|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||Fisher Exact|||Any Improvement||||<0.0001
72438642|NCT00071799|144390845|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||Fisher Exact|||Erythroid Response - Major||||<0.0001
72438643|NCT00071799|144390845|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6203||95.0|||||Fisher Exact|||Erythroid Response - Minor||||0.6203
72438644|NCT00071799|144390845|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0003||95.0|||||Fisher Exact|||Platelet Response - Major||||0.0003
72438645|NCT00071799|144390845|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7514||95.0|||||Fisher Exact|||Platelet Response - Minor||||0.7514
72438646|NCT00071799|144390845|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8695||95.0|||||Fisher Exact|||Neutrophil Response - Major||||0.8695
72438647|NCT00071799|144390845|SUPERIORITY_OR_OTHER_LEGACY|||||||0.176||95.0|||||Fisher Exact|||Neutrophil Response - Minor||||0.1760
72438648|NCT00071799|144390846|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0466||95.0||||The p value is two-sided from the log rank test which compares whether the azacitidine and control group follow the same duration curve.|Log Rank|||||||0.0466
72504644|NCT02495077|144540072|SUPERIORITY|||||||0.497|||||||Fisher Exact|||||||0.497
72618889|NCT01260324|144768303|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.73|||||TWO_SIDED|95.0|0.58|0.91|||||Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.|Odds ratio Year 2005||0.91|0.58|
72438649|NCT00071799|144390846|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.73||||0.0474|TWO_SIDED|95.0|0.53|1.0|||Regression, Cox|||||1.00|0.53|0.0474
72438650|NCT00071799|144390847|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0002||95.0||||The p value is two-sided from the log rank test which compares whether the azacitidine and control group follow the same duration curve.|Log Rank|||||||0.0002
72438651|NCT00071799|144390848|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.67||||0.1327|TWO_SIDED|95.0|0.35|1.2|||exact binomial|||||1.20|0.35|0.1327
72438652|NCT00071799|144390850|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0||||The p value is two-sided from the log rank test stratified by the randomization stratification factors of IPSS classification and FAB classification|Log Rank|||||||<0.0001
72438653|NCT00071799|144390850|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.5|||<|0.0001|TWO_SIDED|95.0|0.35|0.7|||Regression, Cox||Cox proportional hazards model stratified on the randomization factors of FAB and IPSS with model term of treatment.|||0.70|0.35|<0.0001
72438654|NCT04532528|144390867|OTHER|No formal hypotheses were tested.||||||0.9701|||||||Chi-squared|||||||0.9701
72438655|NCT04532528|144390868|OTHER|No formal hypotheses were tested.||||||0.7376|||||||Chi-squared|||At 3 months only||||0.7376
72438656|NCT04532528|144390868|OTHER|No formal hypotheses were tested.||||||0.1356|||||||Chi-squared|||At 6 months only||||0.1356
72438657|NCT04532528|144390868|OTHER|No formal hypotheses were tested.||||||0.68|||||||Chi-squared|||At 9 months only||||0.6800
72438658|NCT04532528|144390869|OTHER|No formal hypotheses were tested.||||||0.5777|||||||Chi-squared|||At 3 months only||||0.5777
72438659|NCT04532528|144390869|OTHER|No formal hypotheses were tested.||||||0.3313|||||||Chi-squared|||At 6 months only||||0.3313
72438660|NCT04532528|144390869|OTHER|No formal hypotheses was tested.||||||0.5697|||||||Chi-squared|||At 9 months only||||0.5697
72438661|NCT04532528|144390869|OTHER|No formal hypotheses were tested.||||||0.5135|||||||Chi-squared|||At 12 months only||||0.5135
72438662|NCT04532528|144390870|OTHER|No formal hypotheses were tested.||||||0.8509|||||||Chi-squared|||At 3 months only||||0.8509
72438663|NCT04532528|144390870|OTHER|No formal hypotheses were tested.||||||0.3302|||||||Chi-squared|||At 6 months only||||0.3302
72438664|NCT04532528|144390870|OTHER|No formal hypotheses was tested.||||||0.9005|||||||Chi-squared|||At 9 months only||||0.9005
72438665|NCT04532528|144390870|OTHER|No formal hypotheses were tested.||||||0.2789|||||||Chi-squared|||At 12 months only||||0.2789
72438666|NCT04532528|144390871|OTHER|No formal hypotheses were tested.||||||0.667|||||||Wilcoxon (Mann-Whitney)|||At 3 months only||||0.6670
72438667|NCT04532528|144390871|OTHER|||||||0.1285|||||||Wilcoxon (Mann-Whitney)|||At 6 months only||||0.1285
72438668|NCT04532528|144390871|OTHER|No formal hypotheses was tested.||||||0.7151|||||||Wilcoxon (Mann-Whitney)|||At 9 months only||||0.7151
72438669|NCT04532528|144390871|OTHER|No formal hypotheses were tested||||||0.803|||||||Wilcoxon (Mann-Whitney)|||At 12 months only||||0.8030
72438670|NCT01636687|144390875|SUPERIORITY_OR_OTHER||Risk Difference (RD)|53.3|||<|0.0001|TWO_SIDED|95.0|36.6|67.7|||Fisher Exact|||Response criterion: IGA 0/1||67.7|36.6|<0.0001
72438671|NCT01636687|144390875|SUPERIORITY_OR_OTHER||Risk Difference (RD)|73.3|||<|0.0001|TWO_SIDED|95.0|58.8|83.9|||Fisher Exact|||Response Criterion: IGA 0/1||83.9|58.8|<0.0001
72438672|NCT01636687|144390875|SUPERIORITY_OR_OTHER||Risk Difference (RD)|68.4|||<|0.0001|TWO_SIDED|95.0|53.1|79.8|||Fisher Exact|||Response criterion: PASI 75||79.8|53.1|<0.0001
72438673|NCT01636687|144390875|SUPERIORITY_OR_OTHER||Risk Difference (RD)|83.4|||<|0.0001|TWO_SIDED|95.0|70.7|91.7|||Fisher Exact|||Response criterion: PASI 75||91.7|70.7|<0.0001
72504645|NCT02495077|144540073|SUPERIORITY|||||||0.622|||||||Fisher Exact|||||||0.622
72504646|NCT02495077|144540075|SUPERIORITY|||||||0.011|||||||Chi-squared|||||||0.011
72504647|NCT02495077|144540076|SUPERIORITY|||||||0.135|||||||Cochran-Mantel-Haenszel|||||||0.135
72504648|NCT02495077|144540077|SUPERIORITY|||||||0.157|||||||Chi-squared|||||||0.157
72618890|NCT01260324|144768303|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.87|||||TWO_SIDED|95.0|0.68|1.12|||||Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.|Odds ratio Year 2006||1.12|0.68|
72386294|NCT01436396|144280295|NON_INFERIORITY|The non-inferiority was demonstrated if the lower limit of the 95% Confidence Interval (CI) was greater than -10. The difference in percentage of seroconversion rates between group 1 and 2 was based on the Wilson score (without continuity adjustment) 95% two-sided CI.|Difference in percentage|0.334|||||TWO_SIDED|95.0|-0.976|1.87||||||Non-inferiority of YF seroconversion rate was assessed 28 days post-Stamaril®/CYD dengue vaccine (CYD Dengue Vaccine Group) or post-Stamaril®/placebo (Placebo Group).||1.87|-0.976|
72386295|NCT01436396|144280296|NON_INFERIORITY|The non-inferiority was demonstrated if the lower limit of the 95% CI is greater than -10. The difference in percentage of seroconversion rates between group 1 and 2 was based on the Wilson score (without continuity adjustment) 95% two-sided CI.|Difference in percentage|-1.06|||||TWO_SIDED|95.0|-2.81|0.383||||||Non-inferiority of YF seroconversion rate was assessed 28 days post-Stamaril®/CYD dengue vaccine (CYD Dengue Vaccine Group) or post-Stamaril®/placebo (Placebo Group).||0.383|-2.81|
72438674|NCT03593213|144390903|SUPERIORITY||Hazard Ratio (HR)|0.56|||=|0.1576|TWO_SIDED|95.0|0.25|1.29||The significance level was 0.05 using the log rank test.|Log Rank||Hazard ratio (cariprazine 3.0 or 4.5 mg/day vs. placebo) was based on Cox proportional hazards regression model, with treatment group as an explanatory variable.|||1.29|0.25|=0.1576
72438675|NCT03593213|144390903|SUPERIORITY||Hazard Ratio (HR)|0.61|||=|0.2066|TWO_SIDED|95.0|0.26|1.45||The significance level was 0.05 using the log rank test.|Log Rank||Hazard ratio (cariprazine 3.0 or 4.5 mg/day vs. placebo) was based on Cox proportional hazards regression model, with treatment group as an explanatory variable.|||1.45|0.26|=0.2066
72438676|NCT02658240|144390904|SUPERIORITY|||||||0.05|||||||ANOVA|||The study was powered to detect a mean difference of 1.5 in pain scores in favor of patients undergoing SFICB procedure assuming a standard deviation of 2.5. With a two sided alpha level of 0.05, a total of 52 patients would be needed to have 80% power using a repeated measures ANOVA F test with 6 observations on each subject. Correlation on the repeat observations was assumed to be 0.5. Assuming a 14% loss to follow-up, 60 patients were enrolled at 1:1 ratio.||||0.05
72438677|NCT02658240|144390905|SUPERIORITY|||||||0.05|||||||ANOVA|||||||0.05
72438678|NCT02658240|144390906|SUPERIORITY|||||||0.149|TWO_SIDED|80.0|||||t-test, 2 sided|||||||0.149
72438679|NCT02658240|144390907|SUPERIORITY|||||||0.584|TWO_SIDED|80.0|||||Wilcoxon (Mann-Whitney)|||||||0.584
72438680|NCT04589689|144390931|OTHER|||||||0.777||||||The a priori threshold for statistical significance is \<.05.|t-test, 2 sided|||Analysis at 3 months.||||0.777
72438681|NCT04589689|144390931|OTHER|||||||0.247||||||The a priori threshold for statistical significance is \<.05.|t-test, 2 sided|||Analysis at 6-month.||||0.247
72438682|NCT04589689|144390932|OTHER|||||||0.16||||||The a priori threshold for statistical significance is \<.05.|t-test, 2 sided|||Analysis at 3-month follow-up.||||0.160
72438683|NCT04589689|144390932|OTHER|||||||0.275||||||The a priori threshold for statistical significance is \<.05.|t-test, 2 sided|||Analysis at 6-month follow-up.||||0.275
72504649|NCT02495077|144540078|SUPERIORITY|||||||0.071|||||||Chi-squared|||||||0.071
72386296|NCT01479127|144280344|SUPERIORITY_OR_OTHER|||||||0.058|TWO_SIDED||||||Paired t-test|||"TRS I OFF state"||||0.058
72386297|NCT01479127|144280344|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Paired t-test|||"TRS I Dyskinesia state"||||1.000
72386298|NCT01479127|144280344|SUPERIORITY_OR_OTHER|||||||0.153|TWO_SIDED||||||Paired t-test|||"TRS II Normal state"||||0.153
72386299|NCT01479127|144280344|SUPERIORITY_OR_OTHER|||||||0.14|TWO_SIDED||||||Paired t-test|||"TRS II OFF state"||||0.140
72386300|NCT01479127|144280344|SUPERIORITY_OR_OTHER|||||||0.374|TWO_SIDED||||||Paired t-test|||"TRS II Dyskinesia state"||||0.374
72386301|NCT01479127|144280345|SUPERIORITY_OR_OTHER|||||||0.574|TWO_SIDED||||||Paired t-test|||||||0.574
72386302|NCT01479127|144280345|SUPERIORITY_OR_OTHER|||||||0.661|TWO_SIDED||||||Paired t-test|||ON time w/o D + time with NTD||||0.661
72386303|NCT01479127|144280345|SUPERIORITY_OR_OTHER|||||||0.574|TWO_SIDED||||||Paired t-test|||ON time w/o D + time with NTD + time w/ TD||||0.574
72386304|NCT01479127|144280346|SUPERIORITY_OR_OTHER|||||||0.5|TWO_SIDED||||||Wilcoxon one-sample test|||Rapid alternating movement of hands||||0.500
72386305|NCT01479127|144280346|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Wilcoxon one-sample test|||Arising from chair||||1.000
72438684|NCT04589689|144390933|OTHER|||||||0.509||||||The a priori threshold for statistical significance is \<.05.|t-test, 2 sided|||Analysis at 3-month follow-up.||||0.509
72438685|NCT04589689|144390933|OTHER|||||||0.61||||||The a priori threshold for statistical significance is \<.05.|t-test, 2 sided|||Analysis at 6-month follow-up.||||0.610
72438686|NCT04589689|144390934|OTHER|||||||0.807||||||The a priori threshold for statistical significance is \<.05.|t-test, 2 sided|||Analysis at 3-month follow-up.||||0.807
72438687|NCT04589689|144390934|OTHER|||||||0.826||||||The a priori threshold for statistical significance is \<.05.|t-test, 2 sided|||Analysis at 6-month follow-up.||||0.826
72438688|NCT04589689|144390935|OTHER|||||||0.076||||||The a priori threshold for statistical significance is \<.05.|t-test, 2 sided|||Analysis at 3-month follow-up.||||0.076
72438689|NCT04589689|144390935|OTHER|||||||0.747||||||The a priori threshold for statistical significance is \<.05.|t-test, 2 sided|||Analysis at 6-month follow-up.||||0.747
72438690|NCT04589689|144390936|OTHER|||||||0.154||||||The a priori threshold for statistical significance is \<.05.|t-test, 2 sided|||Analysis at 3-month follow-up.||||0.154
72438691|NCT04589689|144390936|OTHER|||||||0.107||||||The a priori threshold for statistical significance is \<.05.|t-test, 2 sided|||Analysis at 6-month follow-up.||||0.107
72438692|NCT04589689|144390937|OTHER|||||||0.445||||||The a priori threshold for statistical significance is \<.05.|t-test, 2 sided|||Analysis at 3-month follow-up.||||0.445
72438693|NCT04589689|144390937|OTHER|||||||0.543||||||The a priori threshold for statistical significance is \<.05.|t-test, 2 sided|||Analysis at 6-month follow-up.||||0.543
72438694|NCT04589689|144390938|OTHER|||||||0.157||||||The a priori threshold for statistical significance is \<.05.|t-test, 2 sided|||Analysis at 6-month follow-up.||||0.157
72438695|NCT00189202|144390963|EQUIVALENCE|Equivalence margin 8% plus or minus 4.||||||0.28|||||||Mantel Haenszel|||||||0.28
72438696|NCT00189202|144390964|OTHER|||||||0.7|||||||Kaplan-Meier|||||||0.70
72504650|NCT02495077|144540079|SUPERIORITY|||||||0.543|||||||t-test, 2 sided|||||||0.543
72504651|NCT02495077|144540080|SUPERIORITY|||||||0.617|||||||t-test, 2 sided|||||||0.617
72504652|NCT02495077|144540081|SUPERIORITY|||||||0.275|||||||t-test, 2 sided|||||||0.275
72504653|NCT02495077|144540082|SUPERIORITY|||||||0.3|||||||t-test, 2 sided|||||||0.300
72495368|NCT00403260|144519745|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The primary efficacy analysis tested the non-inferiority of the PA group compared to the comparator group with regard to the PCR-corrected ACPR response rate at Day 28 using the 2-sided 95% confidence interval (CI) (Newcombe-Wilson score method without continuity correction). Non-inferiority of PA to MQ + AS was concluded if the lower limit of the CI for the difference was \>-5%.|ACPR percent difference|1.1||||0.106|TWO_SIDED|95.0|-0.2|3.1||If non-inferiority of PA was demonstrated, the p-value associated with a superiority test is calculated based on a 2-sided Chi-square test. If the calculated p-value is \<5%, then the superiority of PA compared to MQ+AS was statistically demonstrated.|Chi-squared|||"Null hypothesis: The PCR-corrected ACPR response rate at Day 28 for the PA group is inferior to the PCR-corrected ACPR response rate at Day 28 for the comparator group (MQ + AS) by more than 5%.~Was tested versus the alternative:~Alternative hypothesis: the PCR-corrected ACPR response rate at Day 28 for the PA group is not inferior to the PCR-corrected ACPR response rate at Day 28 for the comparator group (MQ + AS) by more than -5%."||3.1|-0.2|0.106
72495369|NCT01354028|144519753|SUPERIORITY_OR_OTHER|||||||0.1303||95.0|||||Chi-squared|Degrees of freedom =1||"Null hypothesis: there will be no difference in sleep efficiency in preterm infants on the day of massage versus the day without massage.~Power calculation: the sample size was determined by convenience for this pilot study"||||0.1303
72495370|NCT01354028|144519756|SUPERIORITY_OR_OTHER|||||||0.026||95.0||||Pearson's chi square|Chi-squared|Degrees of freedom=1||"Null hypothesis: there is no difference in massage therapy or no massage therapy in number of infants who will be asleep at the end of massage or the corresponding time frame on the non massage day.~Pearson's chi square=4.98"||||0.026
72495371|NCT02109159|144519757|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.2||||0.44|TWO_SIDED|95.0|0.8|1.4|||Chi-squared||This analysis was conducted on an intention-to-treat (ITT) basis including all participants randomised.|||1.4|0.8|0.44
72495372|NCT02109159|144519757|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.2||||0.47|TWO_SIDED|95.0|0.8|1.7|||Chi-squared||This analysis was conducted on a per-protocol (PP) basis including only those who watched the videos.|||1.7|0.8|0.47
72495373|NCT02109159|144519758|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01||||0.53|TWO_SIDED|95.0|-0.02|0.04|||t-test, 2 sided||This analysis was conducted on an intention-to-treat (ITT) basis including all participants randomised.|||0.04|-0.02|0.53
72495374|NCT02109159|144519758|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2||||0.56|TWO_SIDED|95.0|-0.5|0.8|||t-test, 2 sided||This analysis was conducted on a per-protocol (PP) basis including only those who watched the videos.|||0.8|-0.5|0.56
72495375|NCT01664793|144519763|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Chi-squared|Chi-square tests for comparisons of between-arm changes in vaccination rates from pre to post intervention.||||||<0.05
72495376|NCT03881007|144519765|SUPERIORITY||Incidence rate ratio|1.17||||0.359|TWO_SIDED|95.0|0.84|1.64|||Mixed Models Analysis|||||1.64|0.84|0.359
72495377|NCT03881007|144519766|SUPERIORITY||Incidence rate ratio|5.78||||0.024|TWO_SIDED|95.0|1.52|136.56|||Mixed Models Analysis|||||136.56|1.52|0.024
72386306|NCT01479127|144280346|SUPERIORITY_OR_OTHER|||||||0.25|TWO_SIDED||||||Wilcoxon one-sample test|||Postural stability||||0.250
72495378|NCT03881007|144519767|SUPERIORITY||Incidence rate ratio|1.09||||0.774|TWO_SIDED|95.0|0.61|1.95|||Mixed Models Analysis|||||1.95|0.61|0.774
72386307|NCT01479127|144280346|SUPERIORITY_OR_OTHER|||||||0.5|TWO_SIDED||||||Wilcoxon one-sample test|||Body bradykinesia and hypokinesia||||0.500
72386308|NCT01479127|144280346|SUPERIORITY_OR_OTHER|||||||0.25|TWO_SIDED||||||Wilcoxon one-sample test|||Dyskinesia||||0.250
72386309|NCT01479127|144280347|SUPERIORITY_OR_OTHER|||||||0.87|TWO_SIDED||||||Paired t-test|||Total score||||0.870
72386310|NCT01479127|144280347|SUPERIORITY_OR_OTHER|||||||0.374|TWO_SIDED||||||Paired t-test|||Part I||||0.374
72386311|NCT01479127|144280347|SUPERIORITY_OR_OTHER|||||||0.799|TWO_SIDED||||||Paired t-test|||Part II||||0.799
72386312|NCT01479127|144280347|SUPERIORITY_OR_OTHER|||||||0.493|TWO_SIDED||||||Paired t-test|||Part II (Off-time)||||0.493
72386313|NCT01479127|144280347|SUPERIORITY_OR_OTHER|||||||0.53|TWO_SIDED||||||Paired t-test|||Part III||||0.530
72558775|NCT02312154|144647528|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||The change in each of the biophysical parameters was calculated as the pretreatment value minus the posttreatment value for each visit, and these pre- vs posttreatment changes were used in the statistical analysis to minimize the intraindividual variation between the two cheeks. The Wilcoxon rank-sum test was performed to compare the week-by-week changes in parameters of the right and left cheeks (i.e., treated vs untreated).||||<0.05
72386314|NCT01479127|144280347|SUPERIORITY_OR_OTHER|||||||0.108|TWO_SIDED||||||Paired t-test|||Part IV sub-score of dyskinesia||||0.108
72495379|NCT03881007|144519768|SUPERIORITY||incidence rate ratio|0.59||||0.323|TWO_SIDED|95.0|0.2|1.63|||Mixed Models Analysis|||||1.63|0.2|0.323
72495380|NCT03881007|144519770|SUPERIORITY||Incidence rate ratio|1.21||||0.279|TWO_SIDED|95.0|0.86|1.72|||Mixed Models Analysis|||||1.72|0.86|0.279
72386315|NCT01479127|144280348|SUPERIORITY_OR_OTHER|||||||0.636|TWO_SIDED||||||Paired t-test|||Total score||||0.636
72386316|NCT01479127|144280348|SUPERIORITY_OR_OTHER|||||||0.329|TWO_SIDED||||||Paired t-test|||Domain: Mobility||||0.329
72386317|NCT01479127|144280348|SUPERIORITY_OR_OTHER|||||||0.902|TWO_SIDED||||||Paired t-test|||Domain: Activities of daily living||||0.902
72386318|NCT01479127|144280348|SUPERIORITY_OR_OTHER|||||||0.22|TWO_SIDED||||||Paired t-test|||Domain: Emotional well-being||||0.220
72386319|NCT01479127|144280348|SUPERIORITY_OR_OTHER|||||||0.799|TWO_SIDED||||||Paired t-test|||Domain: Stigma||||0.799
72386320|NCT01479127|144280348|SUPERIORITY_OR_OTHER|||||||0.178|TWO_SIDED||||||Paired t-test|||Domain: Social support||||0.178
72386321|NCT01479127|144280348|SUPERIORITY_OR_OTHER|||||||0.456|TWO_SIDED||||||Paired t-test|||Domain: Cognition||||0.456
72386322|NCT01479127|144280348|SUPERIORITY_OR_OTHER|||||||0.866|TWO_SIDED||||||Paired t-test|||Domain: Communication||||0.866
72386323|NCT01479127|144280348|SUPERIORITY_OR_OTHER|||||||0.576|TWO_SIDED||||||Paired t-test|||Domain: Bodily discomfort||||0.576
72386324|NCT01479127|144280349|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Wilcoxon one-sample test|||"On state staging"||||1.000
72386325|NCT01479127|144280349|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Wilcoxon one-sample test|||"Off state staging"||||1.000
72386326|NCT01479127|144280350|SUPERIORITY_OR_OTHER|||||||0.125|TWO_SIDED||||||Wilcoxon one-sample test|||||||0.125
72438697|NCT01039688|144390972|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.45|STANDARD_ERROR_OF_MEAN|0.14||0.0014|TWO_SIDED|95.0|-0.73|-0.18||A stepdown procedure was used to control for multiple comparisons. In order for the comparison of CP-690,550 5 mg to be statistically significant versus MTX, the comparison of CP-690,550 10 mg versus MTX had to be statistically significant.|ANCOVA|||||-0.18|-0.73|0.0014
72438698|NCT01039688|144390972|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|0.14||0.0004|TWO_SIDED|95.0|-0.77|-0.23||A stepdown procedure was used to control for multiple comparisons. In order for the comparison of CP-690,550 5 mg to be statistically significant versus MTX, the comparison of CP-690,550 10 mg versus MTX had to be statistically significant.|ANCOVA|||||-0.23|-0.77|0.0004
72438699|NCT01039688|144390973|SUPERIORITY_OR_OTHER||Risk Difference (RD)|13.32|||<|0.0001|TWO_SIDED|95.0|6.81|19.82||A stepdown procedure was used to control for multiple comparisons. For comparison of 5 mg to be statistically significant, comparison of 10 mg to MTX in ACR70 and comparison of 5 mg to MTX in change from BL in mTSS had to be statistically significant|Normal approximation|||||19.82|6.81|<0.0001
72438700|NCT01039688|144390973|SUPERIORITY_OR_OTHER||Risk Difference (RD)|25.25|||<|0.0001|TWO_SIDED|95.0|18.51|31.99||A stepdown procedure was used to control for multiple comparisons. For comparison of 10 mg to MTX in ACR70 to be statistically significant, comparison of 10 mg to MTX in change from BL in mTSS had to be statistically significant|Normal approximation|||||31.99|18.51|<0.0001
72438701|NCT03844269|144391078|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|||EEG data excluded if excessive noise (rejection of more than 30% of target trials due to voltage fluctuations greater than ± 100 μV deflections within an epoch) at the pre- or post-intervention assessment||||<0.05
72438702|NCT02384070|144391088|SUPERIORITY_OR_OTHER|||||||1||||||Analysis of the variance was used and Chi-square test for categorical variables. A sample size was calculated for a 95% confidence level and a power of 80%, assuming a 10% difference between groups.|ANOVA|||||||1
72438703|NCT02384070|144391088|SUPERIORITY_OR_OTHER|||||||1||||||The prior threshold for statistical significance was P \< 0.05|ANOVA|||||||1
72438704|NCT01755949|144391097|SUPERIORITY|||||||0.038|||||||t-test, 2 sided|||Baseline C-reactive protein vs day 28 C-reactive protein||||0.038
72558776|NCT02312154|144647529|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||The therapeutic outcome was assessed by patient self-assessment using the Global Aesthetic Improvement Scale, which rates outcome on the following 5-point scale: 3, very much improved; 2, much improved; 1, improved; 0, no change; and -1, worse. Two independent investigators also individually assessed every patient's improvement, and the values of the two scores were averaged for each patient. The Wilcoxon rank-sum test was performed to compare the pre-by-posttreatment changes in treated side.||||<0.05
72438705|NCT01755949|144391097|SUPERIORITY|||||||0.98|||||||t-test, 2 sided|||Baseline C-reactive protein vs day 28 C-reactive protein||||0.98
72618891|NCT01260324|144768303|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.93|||||TWO_SIDED|95.0|0.72|1.19|||||Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.|Odds ratio Year 2007||1.19|0.72|
72438706|NCT01755949|144391097|SUPERIORITY|||||||0.072|||||||t-test, 2 sided|||difference between placebo and colchicine levels at day 28||||0.072
72438707|NCT01755949|144391098|SUPERIORITY|||||||0.08|||||||t-test, 2 sided|||placebo vs colchicine||||0.08
72438708|NCT05082935|144391100|SUPERIORITY||Mean Difference (Final Values)|0.048||||0.09|TWO_SIDED|95.0|-0.008|0.104|||ANCOVA|||||0.104|-0.008|0.09
72438709|NCT05082935|144391101|SUPERIORITY||Mean Difference (Final Values)|0.15||||0.02|TWO_SIDED|95.0|0.02|0.29|||ANCOVA|||||0.29|0.02|0.02
72438710|NCT05082935|144391102|SUPERIORITY||Ratio of Means|-0.076||||0.03|TWO_SIDED|95.0|-0.145|-0.007|||ANCOVA|||||-0.007|-0.145|0.03
72438711|NCT05082935|144391103|SUPERIORITY||Mean Difference (Final Values)|0.03||||0.38|TWO_SIDED|95.0|-0.04|0.09|||ANCOVA|||||0.09|-0.04|0.38
72438712|NCT05082935|144391104|SUPERIORITY||Mean Difference (Final Values)|0.096||||0.002|TWO_SIDED|95.0|0.04|0.16|||ANCOVA|||||0.16|0.04|0.002
72438713|NCT02755116|144391124|SUPERIORITY||Adjusted relative risk|0.76||||0.003|TWO_SIDED|95.0|0.48|1.2|||log-binomial regression|||||1.20|0.48|0.003
72438714|NCT02200770|144391129|SUPERIORITY||Hazard Ratio (HR)|0.272|||<|0.0001|TWO_SIDED|95.0|0.1496|0.4961|||Regression, Cox|||||0.4961|0.1496|<0.0001
72438715|NCT02200770|144391130|SUPERIORITY||Odds Ratio (OR)|0.352||||0.0033|TWO_SIDED|95.0|0.1755|0.7059|||Regression, Logistic|||||0.7059|0.1755|0.0033
72438716|NCT02200770|144391131|SUPERIORITY||Mean Difference (Net)|0.134|STANDARD_ERROR_OF_MEAN|1.096||0.9026|TWO_SIDED|95.0|-2.0254|2.2941|||ANCOVA|||||2.2941|-2.0254|0.9026
72438717|NCT02200770|144391132|SUPERIORITY||Rate Ratio|0.566||||0.0034|TWO_SIDED|95.0|0.3866|0.8279|||Negative Binomial Regression|||||0.8279|0.3866|0.0034
72438718|NCT02200770|144391133|SUPERIORITY||Rate Ratio|0.317||||0.0146|TWO_SIDED|95.0|0.1257|0.7972|||Negative Binomial Regression|||||0.7972|0.1257|0.0146
72438719|NCT02214160|144391148|SUPERIORITY|||||||0.0347|||||||Paired T-test|||||||0.0347
72438720|NCT02214160|144391149|SUPERIORITY|||||||0.0343|||||||Wilcoxon Signed Rank Test|||||||0.0343
72438721|NCT02423798|144391165|OTHER||Mean|9.13|||||TWO_SIDED|||||||||||||
72438722|NCT01063972|144391168|SUPERIORITY|||||||0.46|||||||Chi-squared|||||||0.46
72438723|NCT01063972|144391169|SUPERIORITY|||||||0.22|||||||Chi-squared|||||||0.22
72438724|NCT01063972|144391170|SUPERIORITY|||||||0.56|||||||Chi-squared|||||||0.56
72438725|NCT01063972|144391171|SUPERIORITY|||||||0.48|||||||Chi-squared|||||||0.48
72438726|NCT02476409|144391189|SUPERIORITY|||||||0.094|||||||Kruskal-Wallis|||||||0.094
72438727|NCT02476409|144391190|SUPERIORITY|||||||0.166|||||||Kruskal-Wallis|||||||0.166
72438728|NCT02476409|144391190|SUPERIORITY|||||||0.491|||||||Kruskal-Wallis|||||||0.491
72438729|NCT02476409|144391191|SUPERIORITY|||||||0.543|||||||Kruskal-Wallis|||P-value for Change in Dyspnea VAS - Baseline to Day 3 Tolvaptan versus placebo.||||0.543
72438730|NCT02476409|144391192|SUPERIORITY|||||||0.05|||||||Kruskal-Wallis|||||||0.050
72438731|NCT02476409|144391193|SUPERIORITY|||||||0.092|||||||Fisher Exact|||||||0.092
72438732|NCT02476409|144391194|SUPERIORITY|||||||0.034|||||||Kruskal-Wallis|||||||0.034
72438733|NCT02476409|144391195|SUPERIORITY|||||||0.643|||||||Kruskal-Wallis|||||||0.643
72438734|NCT00275392|144391196|SUPERIORITY_OR_OTHER|||||||0.026|TWO_SIDED|||||Interaction effect|RM ANOVA|||||||0.026
72438735|NCT00275392|144391196|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||main effect of time|RM ANOVA|||||||<.001
72495381|NCT02634580|144519779|SUPERIORITY||LS Mean Treatment Difference|-39.35|STANDARD_ERROR_OF_MEAN|3.93|<|0.0001|TWO_SIDED|95.0|-47.23|-31.48||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Model includes treatment group, stratification factor (screening LDL-C level), scheduled visit and the interaction of treatment with scheduled visit.|Evolocumab - Ezetimibe|||-31.48|-47.23|<0.0001
72558777|NCT02312154|144647530|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||The therapeutic outcome was assessed by patient self-assessment using the Global Aesthetic Improvement Scale, which rates outcome on the following 5-point scale: 3, very much improved; 2, much improved; 1, improved; 0, no change; and -1, worse. Two independent investigators also individually assessed every patient's improvement, and the values of the two scores were averaged for each patient. The Wilcoxon rank-sum test was performed to compare the pre-by-posttreatment changes in treated side.||||<0.05
72386327|NCT01479127|144280355|SUPERIORITY_OR_OTHER|||||||0.074|TWO_SIDED||||||Paired t-test|||||||0.074
72386328|NCT02387710|144280363|OTHER||||||>|0.5|||||||Wilcoxon (Mann-Whitney)|||||||>0.5
72386329|NCT02256072|144280367|SUPERIORITY_OR_OTHER||Slope|1.25|STANDARD_ERROR_OF_MEAN|0.45||0.0054|TWO_SIDED|95.0|0.37|2.12|||ANCOVA|||H1: Compared to participants in the attention control group and controlling for baseline assessments, participants receiving the PLAN YOUR LIFESPAN tool will show increased planning with regard to planning behavior score (measured via the Planning Assessment tool) one (efficacy) month after intervention.||2.12|0.37|0.0054
72386330|NCT02256072|144280368|SUPERIORITY_OR_OTHER||Slope|0.244|STANDARD_ERROR_OF_MEAN|0.123||0.0471|TWO_SIDED|||||P-value controlled for significant baseline covariates (sex, importance of religion, stroke, and self efficacy score) and individual participant effect.|Mixed Models Analysis|The p-value is based on the slope estimation provided below.||Secondary analyses will compare baseline variables (current utilization of services, physical function assessment, co-morbidities, social support, health literacy, self-efficacy, and sociodemographics) with outcome (one-at-a-time). Those found to have a significant association with outcome will be included in a linear mixed model, with random effect for intercept. A backward stepwise model building process will be used to determine an overall parsimonious model for outcome.||||0.0471
72386331|NCT02256072|144280369|SUPERIORITY_OR_OTHER||Slope|0.075|STANDARD_ERROR_OF_MEAN|0.094||0.423|TWO_SIDED|||||p-value controlled for significant baseline covariates (confidence in using the internet, self efficacy score, support score, and race/ethnicity.|Mixed Models Analysis|The p-value is based on the slope estimation provided below.|The score is the equally-weighted sum of responses to the five questions in the CAHS instrument. Each question has a scale of 1-5, with a total possible range of 5-25. No subscores are calculated.|H2: Compared to participants in the attention control group and controlling for baseline assessments, participants receiving the PLAN YOUR LIFESPAN tool will show increased confidence in accessing home services (measured via the Confidence in Accessing Home Services tool) one (efficacy) and three (effect retention) months after intervention.||||0.423
72386332|NCT02256072|144280370|SUPERIORITY_OR_OTHER||Slope|0.22|STANDARD_ERROR_OF_MEAN|0.05|<|0.0001|TWO_SIDED|||||p-value controlled for significant baseline covariates (sex, income, health literacy, education level, high blood pressure, and kidney disease) and individual participant effect.|Mixed Models Analysis|The p-value is based on the slope estimation provided below.||Compared to participants in the attention control group, participants receiving PLAN YOUR LIFESPAN will show increased UHS 1 (efficacy) and 3 (effect retention) months post-intervention. Secondary analyses will compare baseline variables with outcome (one-at-a-time). Those with a significant association with outcome will be included in a LMM for UHS, with random effect for intercept. A backward stepwise model building process will be used to determine an overall parsimonious model for UHS.||||<0.0001
72386333|NCT01848704|144280412|SUPERIORITY||Mean Difference (Final Values)|0.71||||0.03|TWO_SIDED|95.0|0.07|1.35|||Mixed Models Analysis|||||1.35|0.07|0.03
72386334|NCT01848704|144280413|SUPERIORITY||Mean Difference (Final Values)|-0.59||||0.03|TWO_SIDED|95.0|-1.13|-0.05|||Mixed Models Analysis|||||-0.05|-1.13|0.03
72386335|NCT01848704|144280414|SUPERIORITY||Mean Difference (Final Values)|-0.38||||0.18|TWO_SIDED|95.0|-0.95|0.19|||Mixed Models Analysis|||||0.19|-0.95|0.18
72386336|NCT01848704|144280415|SUPERIORITY||Mean Difference (Final Values)|0.77||||0.029|TWO_SIDED|95.0|0.08|1.47|||Mixed Models Analysis|||||1.47|0.08|0.029
72386337|NCT01848704|144280416|SUPERIORITY||Mean Difference (Final Values)|0.64||||0.061|TWO_SIDED|95.0|-0.03|1.31|||Mixed Models Analysis|||||1.31|-0.03|0.061
72386338|NCT02155881|144280440|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.02||||0.9716|TWO_SIDED|95.0|-0.98|1.01|||ANCOVA|||An analysis of covariance (ANCOVA) model adjusted for treatment, site and the baseline score was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 5% level of significance.||1.01|-0.98|0.9716
72386339|NCT02155881|144280441|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.08||||0.8713|TWO_SIDED|95.0|-0.87|1.02|||ANCOVA|||An ANCOVA model adjusted for treatment, site and the baseline score was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 5% level of significance.||1.02|-0.87|0.8713
72386340|NCT02155881|144280442|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.1||||0.7789|TWO_SIDED|95.0|-0.61|0.81|||ANCOVA|||An ANCOVA model adjusted for treatment, site and the baseline score was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 5% level of significance.||0.81|-0.61|0.7789
72386341|NCT02155881|144280443|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.15||||0.663|TWO_SIDED|95.0|-0.55|0.86|||ANCOVA|||An ANCOVA model adjusted for treatment, site and the baseline score was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 5% level of significance.||0.86|-0.55|0.6630
72386342|NCT02155881|144280444|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.08||||0.5593|TWO_SIDED|95.0|-0.35|0.19|||ANCOVA|||Nasal congestion: An ANCOVA model adjusted for treatment, site and the baseline score was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 5% level of significance.||0.19|-0.35|0.5593
72386343|NCT02155881|144280444|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.05||||0.7085|TWO_SIDED|95.0|-0.22|0.33|||ANCOVA|||Runny nose: An ANCOVA model adjusted for treatment, site and the baseline score was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 5% level of significance.||0.33|-0.22|0.7085
72438736|NCT00275392|144391196|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||main effect of group|RM ANOVA|||||||>.05
72438737|NCT00275392|144391197|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||Interaction effect|RM ANOVA|||||||> 0.05
72438738|NCT00275392|144391197|SUPERIORITY_OR_OTHER|||||||0.016|TWO_SIDED|||||main effect of time|RM ANOVA|||||||.016
72386344|NCT02155881|144280444|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.05||||0.7309|TWO_SIDED|95.0|-0.22|0.31|||ANCOVA|||Itching: An ANCOVA model adjusted for treatment, site and the baseline score was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 5% level of significance.||0.31|-0.22|0.7309
72386345|NCT02155881|144280444|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.01||||0.9584|TWO_SIDED|95.0|-0.29|0.3|||ANCOVA|||Sneezing: An ANCOVA model adjusted for treatment, site and the baseline score was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 5% level of significance.||0.30|-0.29|0.9584
72386346|NCT02155881|144280445|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.17||||0.2266|TWO_SIDED|95.0|-0.11|0.46|||ANCOVA|||Itching/Burning Eyes: An ANCOVA model adjusted for treatment, site and the baseline score was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 5% level of significance.||0.46|-0.11|0.2266
72386347|NCT02155881|144280445|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.09||||0.4888|TWO_SIDED|95.0|-0.35|0.17|||ANCOVA|||Redness: An ANCOVA model adjusted for treatment, site and the baseline score was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 5% level of significance.||0.17|-0.35|0.4888
72386348|NCT02155881|144280445|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.03||||0.8316|TWO_SIDED|95.0|-0.22|0.27|||ANCOVA|||Tearing/Watering Eyes: An ANCOVA model adjusted for treatment, site and the baseline score was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 5% level of significance.||0.27|-0.22|0.8316
72386349|NCT02155881|144280446|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.28||||0.2968|TWO_SIDED|95.0|-0.8|0.25|||ANCOVA|||An ANCOVA model adjusted for treatment, site and the baseline score was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 5% level of significance.||0.25|-0.80|0.2968
72386350|NCT02155881|144280447|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.27||||0.3533|TWO_SIDED|95.0|-0.85|0.31|||ANCOVA|||Activities: An ANCOVA model adjusted for treatment, site and the baseline score was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 5% level of significance.||0.31|-0.85|0.3533
72386351|NCT02155881|144280447|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.26||||0.3712|TWO_SIDED|95.0|-0.84|0.32|||ANCOVA|||Sleep: An ANCOVA model adjusted for treatment, site and the baseline score was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 5% level of significance.||0.32|-0.84|0.3712
72386352|NCT02155881|144280447|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.2||||0.4098|TWO_SIDED|95.0|-0.69|0.29|||ANCOVA|||Non-nose/Eye symptoms: An ANCOVA model adjusted for treatment, site and the baseline score was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 5% level of significance.||0.29|-0.69|0.4098
72386353|NCT02155881|144280447|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.36||||0.2683|TWO_SIDED|95.0|-1.0|0.28|||ANCOVA|||Practical Problems: An ANCOVA model adjusted for treatment, site and the baseline score was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 5% level of significance.||0.28|-1.00|0.2683
72386354|NCT02155881|144280447|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.22||||0.4643|TWO_SIDED|95.0|-0.82|0.38|||ANCOVA|||Nasal Symptoms: An ANCOVA model adjusted for treatment, site and the baseline score was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 5% level of significance.||0.38|-0.82|0.4643
72386355|NCT02155881|144280447|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.2||||0.4502|TWO_SIDED|95.0|-0.74|0.33|||ANCOVA|||Eye symptoms: An ANCOVA model adjusted for treatment, site and the baseline score was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 5% level of significance.||0.33|-0.74|0.4502
72438739|NCT00275392|144391197|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||Main effect of Group|RM ANOVA|||||||>.05
72438740|NCT02396316|144391296|SUPERIORITY_OR_OTHER||Difference of LS mean change|-4.9||||0.0644|TWO_SIDED|95.0|-10.2|0.3|||ANCOVA|||Point estimate, 95% CI and P-value were based on treatment difference of the LS mean changes using an ANCOVA model with treatment group and stage of NVG for randomization as fixed effects, baseline value as covariate. The superiority of aflibercept injection to sham injection was to be established if the upper limit of the two-sided 95% confidence interval for the difference (the aflibercept group minus the sham group) is less than 0.||0.3|-10.2|0.0644
72386356|NCT02155881|144280447|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.39||||0.177|TWO_SIDED|95.0|-0.95|0.18|||ANCOVA|||Emotional: An ANCOVA model adjusted for treatment, site and the baseline score was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 5% level of significance.||0.18|-0.95|0.1770
72386357|NCT03488355|144280484|SUPERIORITY||Risk Ratio (RR)|1.15||||0.45|TWO_SIDED||||||t-test, 2 sided|||||||0.45
72438741|NCT02396316|144391297|SUPERIORITY_OR_OTHER||MH adjusted difference|59.1|||||TWO_SIDED|95.0|37.0|81.2|||Mantel Haenszel|||The point estimate of the treatment difference (the aflibercept group minus the sham group) at Week 1 and its two-sided 95% confidence interval stratified by stage of NVG (as randomized) using Mantel-Haenszel weights.||81.2|37.0|
72438742|NCT02189252|144391298|SUPERIORITY_OR_OTHER||Geometric mean ratio in %|160.05||||0.2702|TWO_SIDED|95.0|64.71|395.82||The closed sequential testing procedure stopped at this step as the P Value is greater than 0.05.|Mixed Models Analysis|||In order to address the issue of multiple testing while maintaining overall type I error, a closed testing sequence was used involving 4 analyses stated in the primary objective of this study. In total, 4 statistical tests, each at a significance level of 5%, were carried along the fixed sequence until the first statistically non-significant treatment difference was observed (i.e. p-value\>0.05). This is the first test in the fixed testing sequence.||395.82|64.71|0.2702
72504654|NCT02495077|144540083|SUPERIORITY|||||||0.152|||||||t-test, 2 sided|||||||0.152
72504655|NCT02495077|144540084|SUPERIORITY|||||||0.181|||||||t-test, 2 sided|||||||0.181
72495382|NCT02634580|144519780|SUPERIORITY||LS Mean Treatment Difference|-40.14|STANDARD_ERROR_OF_MEAN|4.26|<|0.0001|TWO_SIDED|95.0|-48.68|-31.6||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Model includes treatment group, stratification factor (screening LDL-C level), scheduled visit and the interaction of treatment with scheduled visit.|Evolocumab - Ezetimibe|||-31.60|-48.68|< 0.0001
72495383|NCT02634580|144519781|SUPERIORITY||LS Mean Treatment Difference|-77.6|STANDARD_ERROR_OF_MEAN|8.1|<|0.0001|TWO_SIDED|95.0|-93.9|-61.3||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Model includes treatment group, stratification factor (screening LDL-C level), scheduled visit and the interaction of treatment with scheduled visit.|Evolocumab - Ezetimibe|||-61.3|-93.9|<0.0001
72495384|NCT02634580|144519782|SUPERIORITY||LS Mean Treatment Difference|-79.4|STANDARD_ERROR_OF_MEAN|8.7|<|0.0001|TWO_SIDED|95.0|-96.7|-62.0||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Model includes treatment group, stratification factor (screening LDL-C level), scheduled visit and the interaction of treatment with scheduled visit.|Evolocumab - Ezetimibe|||-62.0|-96.7|<0.0001
72495385|NCT02634580|144519783|SUPERIORITY||Treatment Difference|56.41|||<|0.0001|TWO_SIDED|95.0|34.1|70.7||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Cochran Mantel Haenszel (CMH) test adjusted by the stratification factor (screening LDL-C level).|Evolocumab - Ezetimibe|||70.70|34.10|<0.0001
72495386|NCT02634580|144519784|SUPERIORITY||Treatment Difference|52.63|||<|0.0001|TWO_SIDED|95.0|30.36|67.52||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Cochran Mantel Haenszel (CMH) test adjusted by the stratification factor (screening LDL-C level).|Evolocumab - Ezetimibe|||67.52|30.36|< 0.0001
72495387|NCT02634580|144519785|SUPERIORITY||LS Mean Treatment Difference|-25.44|STANDARD_ERROR_OF_MEAN|2.68|<|0.0001|TWO_SIDED|95.0|-30.8|-20.08||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Model includes treatment group, stratification factor (screening LDL-C level), scheduled visit and the interaction of treatment with scheduled visit.|Evolocumab - Ezetimibe|||-20.08|-30.80|<0.0001
72495388|NCT02634580|144519786|SUPERIORITY||LS Mean Treatment Difference|-25.83|STANDARD_ERROR_OF_MEAN|2.89|<|0.0001|TWO_SIDED|95.0|-31.63|-20.04||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Model includes treatment group, stratification factor (screening LDL-C level), scheduled visit and the interaction of treatment with scheduled visit.|Evolocumab - Ezetimibe|||-20.04|-31.63|<0.0001
72495389|NCT02634580|144519787|SUPERIORITY||LS Mean Treatment Difference|-33.53|STANDARD_ERROR_OF_MEAN|3.42|<|0.0001|TWO_SIDED|95.0|-40.38|-26.68||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Model includes treatment group, stratification factor (screening LDL-C level), scheduled visit and the interaction of treatment with scheduled visit.|Evolocumab - Ezetimibe|||-26.68|-40.38|< 0.0001
72495390|NCT02634580|144519788|SUPERIORITY||LS Mean Treatment Difference|-33.44|STANDARD_ERROR_OF_MEAN|3.75|<|0.0001|TWO_SIDED|95.0|-40.94|-25.94||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Model includes treatment group, stratification factor (screening LDL-C level), scheduled visit and the interaction of treatment with scheduled visit.|Evolocumab - Ezetimibe|||-25.94|-40.94|<0.0001
72495391|NCT02634580|144519789|SUPERIORITY||LS Mean Treatment Difference|-35.67|STANDARD_ERROR_OF_MEAN|3.31|<|0.0001|TWO_SIDED|95.0|-42.3|-29.04||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Model includes treatment group, stratification factor (screening LDL-C level), scheduled visit and the interaction of treatment with scheduled visit.|Evolocumab - Ezetimibe|||-29.04|-42.30|< 0.0001
72495392|NCT02634580|144519790|SUPERIORITY||LS Mean Treatment Difference|-36.6|STANDARD_ERROR_OF_MEAN|3.68|<|0.0001|TWO_SIDED|95.0|-43.98|-29.22||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Model includes treatment group, stratification factor (screening LDL-C level), scheduled visit and the interaction of treatment with scheduled visit.|Evolocumab - Ezetimibe|||-29.22|-43.98|<0.0001
72495393|NCT02634580|144519791|SUPERIORITY||LS Mean Treatment Difference|-28.61|STANDARD_ERROR_OF_MEAN|3.32|<|0.0001|TWO_SIDED|95.0|-35.26|-21.97||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Model includes treatment group, stratification factor (screening LDL-C level), scheduled visit and the interaction of treatment with scheduled visit.|Evolocumab - Ezetimibe|||-21.97|-35.26|< 0.0001
72495394|NCT02634580|144519792|SUPERIORITY||LS Mean Treatment Difference|-27.05|STANDARD_ERROR_OF_MEAN|3.47|<|0.0001|TWO_SIDED|95.0|-34.0|-20.09||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Model includes treatment group, stratification factor (screening LDL-C level), scheduled visit and the interaction of treatment with scheduled visit.|Evolocumab - Ezetimibe|||-20.09|-34.00|< 0.0001
72495395|NCT02634580|144519793|SUPERIORITY||LS Mean Treatment Difference|-37.07|STANDARD_ERROR_OF_MEAN|3.28|<|0.0001|TWO_SIDED|95.0|-43.65|-30.5||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Model includes treatment group, stratification factor (screening LDL-C level), scheduled visit and the interaction of treatment with scheduled visit.|Evolocumab - Ezetimibe|||-30.50|-43.65|<0.0001
72558778|NCT04442503|144647546|SUPERIORITY||Least Square Mean Difference|-4.0|STANDARD_ERROR_OF_MEAN|1.16||0.0007|TWO_SIDED|95.0|-6.3|-1.7|||MMRM|||Change from Baseline at Day 15||-1.7|-6.3|0.0007
72558779|NCT04442503|144647547|SUPERIORITY||LS Mean Difference|-3.4|STANDARD_ERROR_OF_MEAN|0.999||0.0008|TWO_SIDED|95.0|-5.4|-1.4|||MMRM|||Change from Baseline at Day 3||-1.4|-5.4|0.0008
72558780|NCT04442503|144647547|SUPERIORITY||LS Mean Difference|-2.9|STANDARD_ERROR_OF_MEAN|1.244||0.0203|TWO_SIDED|95.0|-5.4|-0.5|||MMRM|||Change from Baseline at Day 28||-0.5|-5.4|0.0203
72558781|NCT04442503|144647547|SUPERIORITY||LS Mean Difference|-3.5|STANDARD_ERROR_OF_MEAN|1.277||0.0067|TWO_SIDED|95.0|-6.0|-1.0|||MMRM|||Change from Baseline at Day 45||-1.0|-6.0|0.0067
72558782|NCT04442503|144647548|SUPERIORITY||LS Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.196||0.0052|TWO_SIDED|95.0|-0.9|-0.2|||MMRM|||Change from Baseline at Day 15||-0.2|-0.9|0.0052
72438743|NCT02189252|144391298|SUPERIORITY_OR_OTHER||Geometric mean ratio in %|121.61||||0.6367|TWO_SIDED|95.0|49.17|300.76||The p-value was only interpreted descriptively|Mixed Models Analysis|||In order to address the issue of multiple testing while maintaining overall type I error, a closed testing sequence was used involving 4 analyses stated in the primary objective of this study. In total, 4 statistical tests, each at a significance level of 5%, were carried along the fixed sequence until the first statistically non-significant treatment difference was observed (i.e. p-value\>0.05). This is the second test in the fixed testing sequence.||300.76|49.17|0.6367
72438744|NCT02189252|144391299|SUPERIORITY_OR_OTHER||Geometric mean ratio in %|193.91||||0.0511|TWO_SIDED|95.0|99.61|377.47||The p-value was only interpreted descriptively|Mixed Models Analysis|||In order to address the issue of multiple testing while maintaining overall type I error, a closed testing sequence was used involving 4 analyses stated in the primary objective of this study. In total, 4 statistical tests, each at a significance level of 5%, were carried along the fixed sequence until the first statistically non-significant treatment difference was observed (i.e. p-value\>0.05). This is the third test in the fixed testing sequence.||377.47|99.61|0.0511
72438745|NCT02189252|144391299|SUPERIORITY_OR_OTHER||Geometric mean ratio in %|133.32||||0.3543|TWO_SIDED|95.0|68.49|259.52||The p-value was only interpreted descriptively|Mixed Models Analysis|||In order to address the issue of multiple testing while maintaining overall type I error, a closed testing sequence was used involving 4 analyses stated in the primary objective of this study. In total, 4 statistical tests, each at a significance level of 5%, were carried along the fixed sequence until the first statistically non-significant treatment difference was observed (i.e. p-value\>0.05). This is the fourth test in the fixed testing sequence.||259.52|68.49|0.3543
72438746|NCT02189252|144391300|SUPERIORITY_OR_OTHER||Geometric mean ratio in %|259.19||||0.021|TWO_SIDED|95.0|119.75|560.99|||Mixed Models Analysis|||||560.99|119.75|0.0210
72438747|NCT02189252|144391300|SUPERIORITY_OR_OTHER||Geometric mean ratio in %|177.95||||0.1256|TWO_SIDED|95.0|82.22|385.16|||Mixed Models Analysis|||||385.16|82.22|0.1256
72438748|NCT02189252|144391301|SUPERIORITY_OR_OTHER||Geometric mean ratio in %|298.91||||0.0025|TWO_SIDED|95.0|164.32|543.74||The p-value was only interpreted descriptively|Mixed Models Analysis|||||543.74|164.32|0.0025
72438749|NCT02189252|144391301|SUPERIORITY_OR_OTHER||Geometric mean ratio in %|187.28||||0.0418|TWO_SIDED|95.0|102.95|340.66||The p-value was only interpreted descriptively|Mixed Models Analysis|||||340.66|102.95|0.0418
72438750|NCT02189252|144391302|SUPERIORITY_OR_OTHER||Geometric mean ratio in %|79.36||||0.6833|TWO_SIDED|95.0|22.95|274.45|||Mixed Models Analysis|||||274.45|22.95|0.6833
72438751|NCT02189252|144391302|SUPERIORITY_OR_OTHER||Geometric mean ratio in %|69.39||||0.522|TWO_SIDED|95.0|20.07|239.98|||Mixed Models Analysis|||||239.98|20.07|0.5220
72438752|NCT02189252|144391303|SUPERIORITY_OR_OTHER||Geometric mean ratio in %|104.78||||0.9034|TWO_SIDED|95.0|44.92|244.41|||Mixed Models Analysis|||||244.41|44.92|0.9034
72438753|NCT02189252|144391303|SUPERIORITY_OR_OTHER||Geometric mean ratio in %|80.58||||0.5782||95.0|34.55|187.95|||Mixed Models Analysis|||||187.95|34.55|0.5782
72438754|NCT02189252|144391304|SUPERIORITY_OR_OTHER||Geometric mean ratio in %|753.75||||0.0391|TWO_SIDED|95.0|112.03|5071.6|||Mixed Models Analysis|||||5071.6|112.03|0.0391
72438755|NCT02189252|144391304|SUPERIORITY_OR_OTHER||Geometric mean ratio in %|104.98||||0.9578|TWO_SIDED|95.0|15.6|706.33|||Mixed Models Analysis|||||706.33|15.60|0.9578
72438756|NCT02189252|144391305|SUPERIORITY_OR_OTHER||Geometric mean ratio in %|376.64||||0.0186|TWO_SIDED|95.0|128.55|1103.5|||Mixed Models Analysis|||||1103.5|128.55|0.0186
72558783|NCT04442503|144647549|SUPERIORITY||Odds Ratio (OR)|2.02||||0.0209|TWO_SIDED|95.0|1.112|3.67||P-value are from a generalized estimating equation (GEE) for binary response model, with factors for treatment, baseline HAMD-17 total score, baseline antidepressant use, assessment time point, and time-point-by treatment interaction.|GEE Model|||Day 15||3.670|1.112|0.0209
72558784|NCT04442503|144647549|SUPERIORITY||Odds Ratio (OR)|1.534||||0.1661|TWO_SIDED|95.0|0.837|2.812||P-value are from a GEE for binary response model, with factors for treatment, baseline HAMD-17 total score, baseline antidepressant use, assessment time point, and time-point-by treatment interaction.|GEE Model|||Day 45||2.812|0.837|0.1661
72438757|NCT02189252|144391305|SUPERIORITY_OR_OTHER||Geometric mean ratio in %|131.74||||0.5955|TWO_SIDED|95.0|44.97|386.0|||Mixed Models Analysis|||||386.00|44.97|0.5955
72438758|NCT01391832|144391311|SUPERIORITY|Comparison of differences between rTMS+CPT and sham+CPT groups in change Clinical Administered Post-Traumatic Scale Total Severity Scores from baseline to 1-month follow-up.|t-value on group differences in change|-1.51|||>|0.05|ONE_SIDED|||||Predicted effects on symptom reduction were evaluated with α = 0.05 for one-tailed t-distributions, recommended for designs examining efficacy of therapeutic interventions (Overall, 1991).|Mixed Models Analysis|Restricted maximum likelihood estimators of variance components for fixed effects; Satterthwaite estimates of effective degrees of freedom.|degrees of freedom = 327|Restricted maximum likelihood estimators (ReML) of the variance components were used to compute the maximum likelihood estimators of the fixed effects parameters (i.e., group, time, therapist, all two-way interaction terms, and the three-way interaction term). Thus, we did not exclude participants with missing time points.||||>0.05
72438759|NCT01391832|144391311|SUPERIORITY|Comparison of differences between rTMS+CPT and sham+CPT groups in change Clinical Administered Post-Traumatic Scale Total Severity Scores from baseline to 3-month follow-up.|t-value on group differences in change|-2.05|||<|0.05|ONE_SIDED|||||Predicted effects on symptom reduction were evaluated with α = 0.05 for one-tailed t-distributions, recommended for designs examining efficacy of therapeutic interventions (Overall, 1991).|Mixed Models Analysis|Restricted maximum likelihood estimators of variance components for fixed effects; Satterthwaite estimates of effective degrees of freedom.|degrees of freedom = 327|Restricted maximum likelihood estimators (ReML) of the variance components were used to compute the maximum likelihood estimators of the fixed effects parameters (i.e., group, time, therapist, all two-way interaction terms, and the three-way interaction term). Thus, we did not exclude participants with missing time points.||||<0.05
72495396|NCT02634580|144519794|SUPERIORITY||LS Mean Treatment Difference|-36.29|STANDARD_ERROR_OF_MEAN|3.54|<|0.0001|TWO_SIDED|95.0|-43.39|-29.2||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Model includes treatment group, stratification factor (screening LDL-C level), scheduled visit and the interaction of treatment with scheduled visit.|Evolocumab - Ezetimibe|||-29.20|-43.39|<0.0001
72438760|NCT01391832|144391311|SUPERIORITY|Comparison of differences between rTMS+CPT and sham+CPT groups in change Clinical Administered Post-Traumatic Scale Total Severity Scores from baseline to 6-month follow-up.|t-value on group differences in change|-2.01|||<|0.05|ONE_SIDED|||||Predicted effects on symptom reduction were evaluated with α = 0.05 for one-tailed t-distributions, recommended for designs examining efficacy of therapeutic interventions (Overall, 1991).|Mixed Models Analysis|Restricted maximum likelihood estimators of variance components for fixed effects; Satterthwaite estimates of effective degrees of freedom.|degrees of freedom = 327|Restricted maximum likelihood estimators (ReML) of the variance components were used to compute the maximum likelihood estimators of the fixed effects parameters (i.e., group, time, therapist, all two-way interaction terms, and the three-way interaction term). Thus, we did not exclude participants with missing time points.||||<0.05
72438761|NCT01391832|144391312|SUPERIORITY||Mean Difference (Final Values)|-0.666|STANDARD_DEVIATION|0.7101||0.3422|TWO_SIDED|1.422|-0.7548|2.088||It is not adjusted for multiple comparisons.|t-test, 2 sided|degrees of freedom = 58|mean change from baseline to 6-month follow-up, rTMS Active - rTMS Sham|Null hypothesis test of differences in N2 micro-volt change from baseline to 6-month followup.||2.088|-0.7548|.3422
72438762|NCT01391832|144391312|OTHER|The analysis examined correlations in change in N2 and PTSD symptoms.|Slope|-0.3||||0.02|TWO_SIDED|||||Not adjusted|Regression, Linear|||The analysis examined the association between change in PTSD symptoms from baseline to 6-month follow-up and the change in N2 amplitude to the threatening stimulus from baseline to 6-month follow-up.|Correlations for the individual groups were active rTMS r(28)=-.373 and sham rTMS r(32)=-.296.|||0.02
72438763|NCT01154985|144391313|SUPERIORITY_OR_OTHER|||||||0.57|TWO_SIDED||||||Cochran-Armitage trend test|||Proportion of responders in the EPA-E 1800 mg and 2700 mg groups compared to the proportion of responders in the placebo group compared using the Cochran-Armitage trend test in the Efficacy Evaluable analysis set. P-value less than 5% 1-sided. A total sample size of 210 (70 per arm) was planned to give 80% power for detecting a positive dose-response slope among the 3 treatment arms at 12 months.||||0.57
72438764|NCT01154985|144391314|SUPERIORITY_OR_OTHER|||||||0.0137|TWO_SIDED|||||Two-sided p-values testing for significance was performed within treatment group change from baseline and comparisons between treatment groups. Multiple comparison techniques were not applied.|ANCOVA|||Least Squares (LS) mean, 95% CI and 2-sided p-value obtained from ANCOVA model with treatment group as a factor and baseline ALT as a covariate. 1,800 mg/day EPA-E treatment group compared to placebo.||||0.0137
72438765|NCT01154985|144391314|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.2|||||TWO_SIDED|95.0|3.4|29.1||||||Least Squares (LS) mean, 95% CI and 2-sided p-value obtained from ANCOVA model with treatment group as a factor and baseline ALT as a covariate. 1,800 mg/day EPA-E treatment group compared to placebo.||29.1|3.4|
72438766|NCT01154985|144391314|SUPERIORITY_OR_OTHER|||||||0.0006|TWO_SIDED|||||Two-sided p-values testing for significance was performed within treatment group change from baseline and comparisons between treatment groups. Multiple comparison techniques were not applied.|ANCOVA|||Least Squares (LS) mean, 95% CI and 2-sided p-value obtained from ANCOVA model with treatment group as a factor and baseline ALT as a covariate. 2,700 mg/day EPA-E treatment group compared to placebo.||||0.0006
72438767|NCT01154985|144391314|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|22.0|||||TWO_SIDED|95.0|9.6|34.4||||||Least Squares (LS) mean, 95% CI and 2-sided p-value obtained from ANCOVA model with treatment group as a factor and baseline ALT as a covariate. 2,700 mg/day EPA-E treatment group compared to placebo.||34.4|9.6|
72438768|NCT01154985|144391315|SUPERIORITY_OR_OTHER|||||||0.1592|TWO_SIDED|||||Two-sided p-values testing for significance was performed within treatment group change from baseline and comparisons between treatment groups. Multiple comparison techniques were not applied.|ANCOVA|||Least Squares (LS) mean, 95% CI and 2-sided p-value obtained from ANCOVA model with treatment group as a factor and baseline ALT as a covariate. 1,800 mg/day EPA-E treatment group compared to placebo.||||0.1592
72438769|NCT01154985|144391315|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.6|||||TWO_SIDED|95.0|-3.8|23.0||||||Least Squares (LS) mean, 95% CI and 2-sided p-value obtained from ANCOVA model with treatment group as a factor and baseline ALT as a covariate. 1,800 mg/day EPA-E treatment group compared to placebo.||23.0|-3.8|
72438770|NCT01154985|144391315|SUPERIORITY_OR_OTHER|||||||0.0153|TWO_SIDED|||||Two-sided p-values testing for significance was performed within treatment group change from baseline and comparisons between treatment groups. Multiple comparison techniques were not applied.|ANCOVA|||Least Squares (LS) mean, 95% CI and 2-sided p-value obtained from ANCOVA model with treatment group as a factor and baseline ALT as a covariate. 2,700 mg/day EPA-E treatment group compared to placebo.||||0.0153
72438771|NCT01154985|144391315|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.0|||||TWO_SIDED|95.0|3.1|28.9||||||Least Squares (LS) mean, 95% CI and 2-sided p-value obtained from ANCOVA model with treatment group as a factor and baseline ALT as a covariate. 2,700 mg/day EPA-E treatment group compared to placebo.||28.9|3.1|
72438772|NCT00566735|144391317|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 1 sided|Degrees of freedom = 28||Independent t-test to assess differences between the placebo and galantamine groups in regard to pre- and post-ECT scores on the Delayed Memory Index (DMI).||||<0.05
72495397|NCT02634580|144519795|SUPERIORITY||LS Mean Treatment Difference|-31.13|STANDARD_ERROR_OF_MEAN|5.34|<|0.0001|TWO_SIDED|95.0|-41.83|-20.43||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Model includes treatment group, stratification factor (screening LDL-C level), scheduled visit and the interaction of treatment with scheduled visit.|Evolocumab - Ezetimibe|||-20.43|-41.83|<0.0001
72438773|NCT00925587|144391320|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin -0.5 g/dL|Mean Difference (Final Values)|-0.188|STANDARD_ERROR_OF_MEAN|0.122|||TWO_SIDED|95.0|-0.427|0.052|||||Darbepoetin alfa QM - Darbepoetin alfa Q2W|Power = 90% at sample size calculation||0.052|-0.427|
72438774|NCT02164240|144391377|OTHER||Clinical Benefit Rate|0.0|||||TWO_SIDED|95.0|0.0|24.7||descriptive statistics only||||Clinical benefit rate of at least 30% at 16 weeks for the entire, combined population, was considered worthy of further study.||24.7|0|
72495398|NCT02634580|144519796|SUPERIORITY||LS Mean Treatment Difference|-31.21|STANDARD_ERROR_OF_MEAN|6.17|<|0.0001|TWO_SIDED|95.0|-43.57|-18.84||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Model includes treatment group, stratification factor (screening LDL-C level), scheduled visit and the interaction of treatment with scheduled visit.|Evolocumab - Ezetimibe|||-18.84|-43.57|<0.0001
72438775|NCT01925469|144391432|SUPERIORITY_OR_OTHER|||||||0.43|||||||Wilcoxon (Mann-Whitney)|Differences in the median change in pain scores were assessed using Wilcoxon rank sum test.||An a priori sample size calculation determined at least 28 patients were needed to detect a clinically significant 13 mm difference in pain score (α=0.05, power =0.80) with a standard deviation of 12 mm. Intention to treat analysis was performed.||||0.43
72438776|NCT01925469|144391433|SUPERIORITY_OR_OTHER|||||||0.4|||||||Fisher Exact|||Fisher exact test was used to assess differences in satisfaction scores by treatment group. Correlation between pain and satisfaction scores was assessed by Spearman's correlation coefficient.||||0.4
72438777|NCT01925469|144391434|SUPERIORITY_OR_OTHER|||||||0.33|||||||Wilcoxon (Mann-Whitney)|||||||0.33
72438778|NCT00773370|144391435|SUPERIORITY_OR_OTHER||difference between slopes|8.43|STANDARD_DEVIATION|7.17|<|0.25|TWO_SIDED|||||Random effects ANOVA with random intercept and random slope compared the time course (slopes) of change in our outcome measures across three time points: baseline, three, and six-months in our two experimental groups--APA-stroke and Sittercise.|ANOVA|||||||<0.25
72438779|NCT00773370|144391435|SUPERIORITY_OR_OTHER||Slope|14.95|STANDARD_DEVIATION|4.92|<|0.004|TWO_SIDED|||||Random effects ANOVA, random intercept, random slope estimating within group change (slope) over time|ANOVA|||Within group change over time||||<0.004
72438780|NCT00773370|144391435|SUPERIORITY_OR_OTHER||Slope|6.52|STANDARD_DEVIATION|5.13||0.218|TWO_SIDED|||||Random effects ANOVA, random intercept, random slope estimating within group change (slope) over time|ANOVA|||Within group change over time||||.218
72438781|NCT00773370|144391436|SUPERIORITY_OR_OTHER||Difference between slopes|0.186|STANDARD_DEVIATION|0.256||0.47|TWO_SIDED|||||Random effects ANOVA with random intercept and random slope compared the time course (slopes) of change in our outcome measures across three time points: baseline, three, and six-months in our two experimental groups--APA-stroke and Sittercise.|ANOVA|||||||.47
72438782|NCT00773370|144391436|SUPERIORITY_OR_OTHER||Slope|0.215|STANDARD_DEVIATION|0.175||0.225|TWO_SIDED|||||Random effects ANOVA, random intercept, random slope estimating within group change (slope) over time|ANOVA|||Within group change over time||||.225
72438783|NCT00773370|144391436|SUPERIORITY_OR_OTHER||Slope|0.029|STANDARD_DEVIATION|0.187||0.88|TWO_SIDED|||||Random effects ANOVA, random intercept, random slope estimating within group change (slope) over time|ANOVA|||Within group change over time||||.88
72438784|NCT00773370|144391437|SUPERIORITY_OR_OTHER||Difference between slopes|0.002|STANDARD_DEVIATION|0.078||0.98|TWO_SIDED|||||Random effects ANOVA with random intercept and random slope compared the time course (slopes) of change in our outcome measures across three time points: baseline, three, and six-months in our two experimental groups--APA-stroke and Sittercise.|ANOVA|||||||.98
72438785|NCT00773370|144391437|SUPERIORITY_OR_OTHER||Slope|0.033|STANDARD_DEVIATION|0.054||0.54|TWO_SIDED|||||Random effects ANOVA, random intercept, random slope estimating within group change (slope) over time|ANOVA|||Within group change over time||||.54
72438786|NCT00773370|144391437|SUPERIORITY_OR_OTHER||Slope|0.031|STANDARD_DEVIATION|0.057||0.59|TWO_SIDED|||||Random effects ANOVA, random intercept, random slope estimating within group change (slope) over time|ANOVA|||Within group change over time||||.59
72438787|NCT00773370|144391438|SUPERIORITY_OR_OTHER||Slope|0.296|STANDARD_DEVIATION|9.77||0.98|TWO_SIDED||||||ANOVA|||Random effects ANOVA with random intercept and random slope was used to compare the time course of change in our outcome measures across three time points: baseline, three, and six-months in our two experimental groups--APA-stroke and Sittercise.||||.98
72438788|NCT00773370|144391438|SUPERIORITY_OR_OTHER||Slope|15.49|STANDARD_DEVIATION|6.19||0.02|TWO_SIDED|||||Random effects ANOVA, random intercept, random slope estimating within group change (slope) over time|ANOVA|||||||.02
72558785|NCT04442503|144647550|SUPERIORITY||Odds Ratio (OR)|1.781||||0.111|TWO_SIDED|95.0|0.876|3.621||P-value are from a GEE for binary response model, with factors for treatment, baseline HAMD-17 total score, baseline antidepressant use, assessment time point, and time-point-by treatment interaction.|GEE Model|||Day 15||3.621|0.876|0.1110
72438789|NCT00773370|144391438|SUPERIORITY_OR_OTHER||Slope|15.193|STANDARD_DEVIATION|7.553||0.051|TWO_SIDED|||||Random effects ANOVA, random intercept, random slope estimating within group change (slope) over time|ANOVA|||||||.051
72438790|NCT01308567|144391441|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.975||||0.7574|TWO_SIDED|95.0|0.819|1.16||P-value from two-sided stratified log-rank test, stratified for ECOG PS score at baseline, measurable disease at baseline and region with commercial availability of cabazitaxel at time of randomization. Threshold for statistical significance = 0.0479|Log Rank||Cabazitaxel 25 mg/m\^2 vs Docetaxel 75 mg/m\^2|Hazard ratio was estimated using a Cox Proportional Hazards regression model. The Cox proportional hazard model was adjusted by Eastern Cooperative Oncology Group performance status (ECOG PS) score at baseline, measurable disease at baseline, and region with commercial availability of cabazitaxel at the time of randomization.||1.16|0.819|0.7574
72438791|NCT01308567|144391441|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.009||||0.9967|TWO_SIDED|95.0|0.85|1.197||P-value from two-sided stratified log-rank test, stratified for ECOG PS score at baseline, measurable disease at baseline and region with commercial availability of cabazitaxel at time of randomization. Threshold for statistical significance = 0.0479|Log Rank||Cabazitaxel 20 mg/m\^2 vs Docetaxel 75 mg/m\^2|Hazard ratio was estimated using a Cox Proportional Hazards regression model. The Cox proportional hazard model was adjusted by ECOG PS score at baseline, measurable disease at baseline, and region with commercial availability of cabazitaxel at the time of randomization.||1.197|0.85|0.9967
72438792|NCT01308567|144391442|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.989|||||TWO_SIDED|95.0|0.849|1.152|||||Cabazitaxel 25 mg/m\^2 vs Docetaxel 75 mg/m\^2|Hazard ratio was estimated using a Cox Proportional Hazards regression model. The Cox proportional hazard model was adjusted by ECOG PS score at baseline, measurable disease at baseline, and region with commercial availability of cabazitaxel at the time of randomization.||1.152|0.849|
72438793|NCT01308567|144391442|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.063|||||TWO_SIDED|95.0|0.913|1.236|||||Cabazitaxel 20 mg/m\^2 vs Docetaxel 75 mg/m\^2|Hazard ratio was estimated using a Cox Proportional Hazards regression model. The Cox proportional hazard model was adjusted by ECOG PS score at baseline, measurable disease at baseline, and region with commercial availability of cabazitaxel at the time of randomization.||1.236|0.913|
72438794|NCT01308567|144391443|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.958|||||TWO_SIDED|95.0|0.785|1.17|||||Cabazitaxel 25 mg/m\^2 vs Docetaxel 75 mg/m\^2|Hazard ratio was estimated using a Cox Proportional Hazards regression model. The Cox proportional hazard model was adjusted by ECOG PS score at baseline, measurable disease at baseline, and region with commercial availability of cabazitaxel at the time of randomization.||1.17|0.785|
72386358|NCT01254630|144280623|SUPERIORITY||Vaccine Efficacy|0.636|||||TWO_SIDED|97.5|0.364|0.791|||||Point estimate and 97.5% CI of vaccine efficacy (primary endpoint) were obtained from a Cox proportional hazards regression model, adjusting for age (\<50 versus ≥50 years of age).|Vaccine efficacy was calculated as 1 minus the hazard ratio of HZ in the V212 group versus the placebo group. The success criterion for vaccine efficacy required that the lower bound of the 97.5% Confidence Interval (CI) be \>0.25.||0.791|0.364|
72386359|NCT01254630|144280624|OTHER||Risk Difference (RD)|1.4|||||TWO_SIDED|95.0|-1.8|4.5||||||||4.5|-1.8|
72386360|NCT01254630|144280625|OTHER||Vaccine Efficacy|0.771|||||TWO_SIDED|95.0|0.48|0.899|||||Point estimate and 95% CI of vaccine efficacy were obtained from a Cox proportional hazards regression model, adjusting for age (\<50 versus ≥50 years of age).|Vaccine efficacy was calculated as 1 minus the hazard ratio of HZ in the V212 group versus the placebo group. The success criterion for vaccine efficacy required that the lower bound of the 95% CI be \>0.25.||0.899|0.480|
72386361|NCT01254630|144280626|OTHER||Vaccine Efficacy|0.874|||||TWO_SIDED|95.0|-0.005|0.984|||||Point estimate and 95% CI of vaccine efficacy were obtained from a Cox proportional hazards regression model, adjusting for age (\<50 versus ≥50 years of age).|Vaccine efficacy was calculated as 1 minus the hazard ratio of HZ in the V212 group versus the placebo group. The success criterion for vaccine efficacy required that the lower bound of the 95% CI be \>0.25.||0.984|-0.005|
72386362|NCT01254630|144280627|OTHER||Vaccine Efficacy|0.746|||||TWO_SIDED|95.0|-1.275|0.972|||||Point estimate and 95% CI of vaccine efficacy were obtained from a Cox proportional hazards regression model, adjusting for age (\<50 versus ≥50 years of age).|Vaccine efficacy was calculated as 1 minus the hazard ratio of HZ in the V212 group versus the placebo group. The success criterion for vaccine efficacy required that the lower bound of the 95% CI be \>0.25.||0.972|-1.275|
72386363|NCT01254630|144280628|OTHER||Risk Difference (RD)|0.5|||||TWO_SIDED|95.0|-0.6|1.6||||||||1.6|-0.6|
72386364|NCT03113916|144280638|SUPERIORITY||Slope|2.63|||=|0.001|TWO_SIDED|95.0|1.05|4.2|||Mixed Models Analysis|||||4.20|1.05|=.001
72386365|NCT03113916|144280639|SUPERIORITY||Slope|-0.49||||0.23|TWO_SIDED|95.0|-1.29|0.31|||Mixed Models Analysis|||||0.31|-1.29|.23
72386366|NCT03113916|144280640|SUPERIORITY||Slope|0.000000676||||0.06|TWO_SIDED|95.0|-0.00000002|0.00000137|||Mixed Models Analysis|||||.00000137|-.00000002|.06
72386367|NCT03113916|144280641|SUPERIORITY||Slope|-5.64||||0.29|TWO_SIDED|95.0|-16.0|4.73|||Mixed Models Analysis||Values given need to be multiplied by 10 to the power of -10 (i.e., x 10\^-10).|||4.73|-16|.29
72386368|NCT03113916|144280642|SUPERIORITY||Slope|0.351||||0.27|TWO_SIDED|95.0|-0.277|0.978|||Mixed Models Analysis|||||.978|-.277|.27
72438795|NCT01308567|144391443|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.916|||||TWO_SIDED|95.0|0.75|1.118|||||Cabazitaxel 20 mg/m\^2 vs Docetaxel 75 mg/m\^2|Hazard ratio was estimated using a Cox Proportional Hazards regression model. The Cox proportional hazard model was adjusted by ECOG PS score at baseline, measurable disease at baseline, and region with commercial availability of cabazitaxel at the time of randomization.||1.118|0.75|
72386369|NCT03113916|144280643|SUPERIORITY||Slope|-0.015||||0.1|TWO_SIDED|95.0|-0.032|0.003|||Mixed Models Analysis|||||.003|-.032|.10
72386370|NCT03113916|144280644|SUPERIORITY||Slope|-11.2||||0.07|TWO_SIDED|95.0|-23.0|0.7|||Mixed Models Analysis|||||0.7|-23.0|.07
72386371|NCT03113916|144280645|SUPERIORITY||Slope|-0.63||||0.12|TWO_SIDED|95.0|-1.41|0.16|||Mixed Models Analysis|||||0.16|-1.41|.12
72386372|NCT03113916|144280646|SUPERIORITY||Slope|0.174||||0.008|TWO_SIDED|95.0|0.05|0.302|||Mixed Models Analysis|||||.302|.050|.008
72438796|NCT01308567|144391445|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.948|||||TWO_SIDED|95.0|0.8|1.123|||||Cabazitaxel 25 mg/m\^2 vs Docetaxel 75 mg/m\^2|Hazard ratio was estimated using a Cox Proportional Hazards regression model. The Cox proportional hazard model was adjusted by ECOG PS score at baseline, measurable disease at baseline, and region with commercial availability of cabazitaxel at the time of randomization.||1.123|0.8|
72386373|NCT03113916|144280647|SUPERIORITY||Slope|0.015||||0.5|TWO_SIDED|95.0|-0.029|0.059|||Mixed Models Analysis|||||.059|-.029|.50
72386374|NCT03113916|144280648|SUPERIORITY||Slope|-0.00003||||0.99|TWO_SIDED|95.0|-0.013|0.013|||Mixed Models Analysis|||||.013|-.013|.99
72386375|NCT02663908|144280660|OTHER||Hazard Ratio (HR)|1.283||||0.5294|TWO_SIDED|95.0|0.589|2.794|||Log Rank|The p-value of the log-rank test is based on comparison of the treatment groups stratified for age group and region.|Baseline hazards for the Cox regression were stratified over variables: age group and region.|||2.794|0.589|0.5294
72386376|NCT02663908|144280661|OTHER||Hazard Ratio (HR)|1.204||||0.7126|TWO_SIDED|95.0|0.448|3.234|||Log Rank|The p-value of the log-rank test is based on comparison of the treatment groups stratified for age group and region.|Baseline hazards for the Cox regression were stratified over variables: age group and region.|||3.234|0.448|0.7126
72386377|NCT02663908|144280662|OTHER||Hazard Ratio (HR)|0.186||||0.0853|TWO_SIDED|95.0|0.022|1.595|||Log Rank|The p-value of the log-rank test is based on comparison of the treatment groups stratified for age group and region.|Baseline hazards for the Cox regression were stratified over variables: age group and region.|||1.595|0.022|0.0853
72386378|NCT02663908|144280663|OTHER||Hazard Ratio (HR)|1.594||||0.5196|TWO_SIDED|95.0|0.381|6.673|||Log Rank|The p-value of the log-rank test is based on comparison of the treatment groups stratified for age group and region.|Baseline hazards for the Cox regression were stratified over variables: age group and region.|||6.673|0.381|0.5196
72386379|NCT02663908|144280664|OTHER||Hazard Ratio (HR)|0.899||||0.8966|TWO_SIDED|95.0|0.181|4.457|||Log Rank|The p-value of the log-rank test is based on comparison of the treatment groups stratified for age group and region.|Baseline hazards for the Cox regression were stratified over variables: age group and region.|||4.457|0.181|0.8966
72386380|NCT02663908|144280665|OTHER||Hazard Ratio (HR)|0.48||||0.3857|TWO_SIDED|95.0|0.088|2.62|||Log Rank|The p-value of the log-rank test is based on comparison of the treatment groups stratified for age group and region.|Baseline hazards for the Cox regression were stratified over variables: age group and region.|||2.620|0.088|0.3857
72558786|NCT04442503|144647550|SUPERIORITY||Odds Ratio (OR)|2.083||||0.0226|TWO_SIDED|95.0|1.108|3.915||P-value are from a GEE for binary response model, with factors for treatment, baseline HAMD-17 total score, baseline antidepressant use, assessment time point, and time-point-by treatment interaction.|GEE Model|||Day 45||3.915|1.108|0.0226
72558787|NCT04442503|144647551|SUPERIORITY||Odds Ratio (OR)|2.23||||0.0089|TWO_SIDED|95.0|1.223|4.072|||MMRM|||Day 15||4.072|1.223|0.0089
72558788|NCT04442503|144647552|SUPERIORITY||LS Mean Difference|-2.2|STANDARD_ERROR_OF_MEAN|0.98||0.0235|TWO_SIDED|95.0|-4.2|-0.3|||MMRM|||Change from Baseline at Day 15||-0.3|-4.2|0.0235
72438797|NCT01308567|144391445|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.047|||||TWO_SIDED|95.0|0.886|1.238|||||Cabazitaxel 20 mg/m\^2 vs Docetaxel 75 mg/m\^2|Hazard ratio was estimated using a Cox Proportional Hazards regression model. The Cox proportional hazard model was adjusted by ECOG PS score at baseline, measurable disease at baseline, and region with commercial availability of cabazitaxel at the time of randomization.||1.238|0.886|
72438798|NCT01308567|144391447|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.189|||||TWO_SIDED|95.0|0.986|1.434|||||Cabazitaxel 25 mg/m\^2 vs Docetaxel 75 mg/m\^2|Hazard ratio was estimated using a Cox Proportional Hazards regression model. The Cox proportional hazard model was adjusted by ECOG PS score at baseline, measurable disease at baseline, and region with commercial availability of cabazitaxel at the time of randomization.||1.434|0.986|
72438799|NCT01308567|144391447|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.189|||||TWO_SIDED|95.0|0.985|1.435|||||Cabazitaxel 20 mg/m\^2 vs Docetaxel 75 mg/m\^2|Hazard ratio was estimated using a Cox Proportional Hazards regression model. The Cox proportional hazard model was adjusted by ECOG PS score at baseline, measurable disease at baseline, and region with commercial availability of cabazitaxel at the time of randomization.||1.435|0.985|
72438800|NCT01308567|144391449|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.121|||||TWO_SIDED|95.0|0.886|1.417|||||Cabazitaxel 25 mg/m\^2 vs Docetaxel 75 mg/m\^2|Hazard ratio was estimated using a Cox Proportional Hazards regression model. The Cox proportional hazard model was adjusted by ECOG PS score at baseline, measurable disease at baseline, and region with commercial availability of cabazitaxel at the time of randomization.||1.417|0.886|
72438801|NCT01308567|144391449|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.014|||||TWO_SIDED|95.0|0.798|1.288|||||Cabazitaxel 20 mg/m\^2 vs Docetaxel 75 mg/m\^2|Hazard ratio was estimated using a Cox Proportional Hazards regression model. The Cox proportional hazard model was adjusted by ECOG PS score at baseline, measurable disease at baseline, and region with commercial availability of cabazitaxel at the time of randomization.||1.288|0.798|
72438802|NCT01112670|144391467|SUPERIORITY_OR_OTHER|||||||0.83||95.0|||||ANOVA|||||||0.83
72438803|NCT01112670|144391468|SUPERIORITY_OR_OTHER|||||||0.67||95.0|||||ANOVA|||||||0.67
72438804|NCT01112670|144391469|SUPERIORITY_OR_OTHER|||||||0.9||95.0|||||ANOVA|||||||0.90
72438805|NCT01112670|144391470|SUPERIORITY_OR_OTHER|||||||0.56||95.0|||||ANOVA|||||||0.56
72438806|NCT01112670|144391471|SUPERIORITY_OR_OTHER|||||||0.97||95.0|||||ANOVA|||||||0.97
72438807|NCT01112670|144391472|SUPERIORITY_OR_OTHER|||||||0.86||95.0|||||ANOVA|||||||0.86
72438808|NCT01112670|144391473|SUPERIORITY_OR_OTHER|||||||0.21||95.0|||||ANOVA|||||||0.21
72438809|NCT01112670|144391474|SUPERIORITY_OR_OTHER|||||||0.22||95.0|||||ANOVA|||||||0.22
72438810|NCT01112670|144391475|SUPERIORITY_OR_OTHER|||||||0.14||95.0|||||ANOVA|||||||0.14
72438811|NCT01112670|144391476|SUPERIORITY_OR_OTHER|||||||0.29||95.0|||||ANOVA|||||||0.29
72438812|NCT01112670|144391477|SUPERIORITY_OR_OTHER|||||||0.43||95.0|||||ANOVA|||||||0.43
72438813|NCT00779870|144391487|SUPERIORITY|||||||0.06|||||||t-test, 2 sided|||||||0.06
72438814|NCT00779870|144391487|SUPERIORITY|||||||0.8|||||||t-test, 2 sided|||||||0.8
72438815|NCT01040689|144391493|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.185|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001||95.0|0.145|0.224|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 5 mcg qd minus Placebo|||0.224|0.145|<0.0001
72438816|NCT01040689|144391493|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.207|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001||95.0|0.167|0.246|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 10 mcg qd minus Placebo|||0.246|0.167|<0.0001
72438817|NCT01040689|144391493|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.173|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001||95.0|0.133|0.212|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Tio 18 mcg qd minus Placebo|||0.212|0.133|<0.0001
72438818|NCT01040689|144391494|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.131|STANDARD_ERROR_OF_MEAN|0.021|<|0.0001||95.0|0.09|0.173|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 5 mcg qd minus Placebo|||0.173|0.090|<0.0001
72438819|NCT01040689|144391494|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.178|STANDARD_ERROR_OF_MEAN|0.021|<|0.0001||95.0|0.136|0.219|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 10 mcg qd minus Placebo|||0.219|0.136|<0.0001
72438820|NCT01040689|144391494|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.123|STANDARD_ERROR_OF_MEAN|0.021|<|0.0001||95.0|0.081|0.164|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Tio 18 mcg qd minus Placebo|||0.164|0.081|<0.0001
72438821|NCT01040689|144391495|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.158|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.121|0.196|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 5 mcg qd minus Placebo|||0.196|0.121|<0.0001
72438822|NCT01040689|144391495|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.192|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.155|0.23|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 10 mcg qd minus Placebo|||0.230|0.155|<0.0001
72438823|NCT01040689|144391495|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.148|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.11|0.185|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Tio 18 mcg qd minus Placebo|||0.185|0.110|<0.0001
72438824|NCT01040689|144391496|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.182|STANDARD_ERROR_OF_MEAN|0.018|<|0.0001||95.0|0.147|0.216|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 5 mcg qd minus Placebo|||0.216|0.147|<0.0001
72438825|NCT01040689|144391496|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.213|STANDARD_ERROR_OF_MEAN|0.018|<|0.0001||95.0|0.178|0.247|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 10 mcg qd minus Placebo|||0.247|0.178|<0.0001
72438826|NCT01040689|144391496|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.132|STANDARD_ERROR_OF_MEAN|0.018|<|0.0001||95.0|0.097|0.167|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Tio 18 mcg qd minus Placebo|||0.167|0.097|<0.0001
72438827|NCT01040689|144391497|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.206|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.17|0.243|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 5 mcg qd minus Placebo|||0.243|0.170|<0.0001
72438828|NCT01040689|144391497|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.215|STANDARD_ERROR_OF_MEAN|0.018|<|0.0001||95.0|0.179|0.252|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 10 mcg qd minus Placebo|||0.252|0.179|<0.0001
72438829|NCT01040689|144391497|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.182|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.146|0.219|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Tio 18 mcg qd minus Placebo|||0.219|0.146|<0.0001
72438830|NCT01040689|144391498|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.213|STANDARD_ERROR_OF_MEAN|0.018|<|0.0001||95.0|0.177|0.249|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 5 mcg qd minus Placebo|||0.249|0.177|<0.0001
72438831|NCT01040689|144391498|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.239|STANDARD_ERROR_OF_MEAN|0.018|<|0.0001||95.0|0.203|0.275|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 10 mcg qd minus Placebo|||0.275|0.203|<0.0001
72438832|NCT01040689|144391498|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.161|STANDARD_ERROR_OF_MEAN|0.018|<|0.0001||95.0|0.125|0.197|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Tio 18 mcg qd minus Placebo|||0.197|0.125|<0.0001
72438833|NCT01040689|144391499|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.213|STANDARD_ERROR_OF_MEAN|0.023|<|0.0001||95.0|0.168|0.258|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 5 mcg qd minus Placebo|||0.258|0.168|<0.0001
72438834|NCT01040689|144391499|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.234|STANDARD_ERROR_OF_MEAN|0.023|<|0.0001||95.0|0.189|0.279|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 10 mcg qd minus Placebo|||0.279|0.189|<0.0001
72438835|NCT01040689|144391499|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.201|STANDARD_ERROR_OF_MEAN|0.023|<|0.0001||95.0|0.156|0.246|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Tio 18 mcg qd minus Placebo|||0.246|0.156|<0.0001
72438836|NCT01040689|144391500|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.133|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.096|0.17|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 5 mcg qd minus Placebo|||0.170|0.096|<0.0001
72438837|NCT01040689|144391500|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.147|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.11|0.184|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 10 mcg qd minus Placebo|||0.184|0.110|<0.0001
72438838|NCT01040689|144391500|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.097|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.06|0.134|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Tio 18 mcg qd minus Placebo|||0.134|0.060|<0.0001
72438839|NCT01040689|144391501|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.282|STANDARD_ERROR_OF_MEAN|0.034|<|0.0001||95.0|0.216|0.348|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 5 mcg qd minus Placebo|||0.348|0.216|<0.0001
72558789|NCT04442503|144647553|SUPERIORITY||LS Mean Difference|-5.1|STANDARD_ERROR_OF_MEAN|1.706||0.0034|TWO_SIDED|95.0|-8.4|-1.7|||MMRM|||Change from Baseline at Day 15||-1.7|-8.4|0.0034
72438840|NCT01040689|144391501|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.303|STANDARD_ERROR_OF_MEAN|0.033|<|0.0001||95.0|0.237|0.368|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 10 mcg qd minus Placebo|||0.368|0.237|<0.0001
72438841|NCT01040689|144391501|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.276|STANDARD_ERROR_OF_MEAN|0.034|<|0.0001||95.0|0.21|0.342|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Tio 18 mcg qd minus Placebo|||0.342|0.210|<0.0001
72438842|NCT01040689|144391502|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.196|STANDARD_ERROR_OF_MEAN|0.033|<|0.0001||95.0|0.131|0.262|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 5 mcg qd minus Placebo|||0.262|0.131|<0.0001
72438843|NCT01040689|144391502|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.252|STANDARD_ERROR_OF_MEAN|0.033|<|0.0001||95.0|0.187|0.318|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 10 mcg qd minus Placebo|||0.318|0.187|<0.0001
72438844|NCT01040689|144391502|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.184|STANDARD_ERROR_OF_MEAN|0.033|<|0.0001||95.0|0.118|0.249|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Tio 18 mcg qd minus Placebo|||0.249|0.118|<0.0001
72558790|NCT04442503|144647554|SUPERIORITY||LS Mean Difference|-5.9|STANDARD_ERROR_OF_MEAN|2.4||0.0151|TWO_SIDED|95.0|-10.6|-1.2|||MMRM|||Change from Baseline in Core Subscale at Day 15||-1.2|-10.6|0.0151
72438845|NCT01040689|144391503|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.24|STANDARD_ERROR_OF_MEAN|0.031|<|0.0001||95.0|0.178|0.301|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 5 mcg qd minus Placebo|||0.301|0.178|<0.0001
72438846|NCT01040689|144391503|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.278|STANDARD_ERROR_OF_MEAN|0.031|<|0.0001||95.0|0.216|0.339|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 10 mcg qd minus Placebo|||0.339|0.216|<0.0001
72438847|NCT01040689|144391503|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.23|STANDARD_ERROR_OF_MEAN|0.031|<|0.0001||95.0|0.168|0.291|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Tio 18 mcg qd minus Placebo|||0.291|0.168|<0.0001
72438848|NCT01040689|144391504|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.268|STANDARD_ERROR_OF_MEAN|0.031|<|0.0001||95.0|0.207|0.33|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 5 mcg qd minus Placebo|||0.330|0.207|<0.0001
72438849|NCT01040689|144391504|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.312|STANDARD_ERROR_OF_MEAN|0.031|<|0.0001||95.0|0.251|0.374|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 10 mcg qd minus Placebo|||0.374|0.251|<0.0001
72438850|NCT01040689|144391504|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.215|STANDARD_ERROR_OF_MEAN|0.031|<|0.0001||95.0|0.153|0.277|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Tio 18 mcg qd minus Placebo|||0.277|0.153|<0.0001
72438851|NCT01040689|144391505|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.317|STANDARD_ERROR_OF_MEAN|0.036|<|0.0001||95.0|0.246|0.388|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 5 mcg qd minus Placebo|||0.388|0.246|<0.0001
72438852|NCT01040689|144391505|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.318|STANDARD_ERROR_OF_MEAN|0.036|<|0.0001||95.0|0.247|0.388|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 10 mcg qd minus Placebo|||0.388|0.247|<0.0001
72438853|NCT01040689|144391505|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.302|STANDARD_ERROR_OF_MEAN|0.036|<|0.0001||95.0|0.231|0.373|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Tio 18 mcg qd minus Placebo|||0.373|0.231|<0.0001
72438854|NCT01040689|144391506|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3|STANDARD_ERROR_OF_MEAN|0.04|<|0.0001||95.0|0.222|0.378|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 5 mcg qd minus Placebo|||0.378|0.222|<0.0001
72438855|NCT01040689|144391506|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.297|STANDARD_ERROR_OF_MEAN|0.04|<|0.0001||95.0|0.22|0.375|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 10 mcg qd minus Placebo|||0.375|0.220|<0.0001
72438856|NCT01040689|144391506|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.295|STANDARD_ERROR_OF_MEAN|0.04|<|0.0001||95.0|0.217|0.373|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Tio 18 mcg qd minus Placebo|||0.373|0.217|<0.0001
72438857|NCT01040689|144391507|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.185|STANDARD_ERROR_OF_MEAN|0.036|<|0.0001||95.0|0.115|0.255|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 5 mcg qd minus Placebo|||0.255|0.115|<0.0001
72438858|NCT01040689|144391507|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.212|STANDARD_ERROR_OF_MEAN|0.036|<|0.0001||95.0|0.143|0.282|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 10 mcg qd minus Placebo|||0.282|0.143|<0.0001
72438859|NCT01040689|144391507|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.129|STANDARD_ERROR_OF_MEAN|0.036||0.0003||95.0|0.059|0.199|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Tio 18 mcg qd minus Placebo|||0.199|0.059|0.0003
72438860|NCT01185561|144391509|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.89|STANDARD_ERROR_OF_MEAN|2.43||0.001|TWO_SIDED|95.0|4.03|13.76|||t-test, 2 sided|||The null hypothesis is that there is no difference in CES-D score between those assigned to the psychoeducational intervention and those assigned to usual medical care six months after randomization.||13.76|4.03|.001
72438861|NCT01185561|144391510|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.82|STANDARD_ERROR_OF_MEAN|3.27||0.02|TWO_SIDED|95.0|1.29|14.37|||t-test, 2 sided|||The null hypothesis is that there is no difference in the State Anxiety Sub-test score between those assigned to the psychoeducational intervention and those assigned to usual medical care six months after randomization.||14.37|1.29|.02
72438862|NCT01185561|144391511|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.48|STANDARD_ERROR_OF_MEAN|2.91||0.005|TWO_SIDED|95.0|2.64|14.31|||t-test, 2 sided|||The null hypothesis is that there is no difference in the State Trait Anxiety Sub-test score between those assigned to the psychoeducational intervention and those assigned to usual medical care six months after randomization.||14.31|2.64|.005
72438863|NCT01185561|144391512|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.73|STANDARD_ERROR_OF_MEAN|3.75||0.85|TWO_SIDED|95.0|-6.77|8.24|||t-test, 2 sided|||The null hypothesis is that there is no difference in the State Trait Anger Expression Sub-test score between those assigned to the psychoeducational intervention and those assigned to usual medical care six months after randomization.||8.24|-6.77|.85
72438864|NCT02594735|144391564|OTHER|||||||0.002|||||||t-test, 2 sided|||||||0.002
72438865|NCT02594735|144391565|OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
72438866|NCT02594735|144391566|OTHER|||||||0.004|||||||t-test, 2 sided|||||||0.004
72438867|NCT02594735|144391567|OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
72438868|NCT02594735|144391568|OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
72438869|NCT02594735|144391569|OTHER|||||||0.375|||||||t-test, 2 sided|||||||0.375
72438870|NCT02594735|144391570|OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
72438871|NCT02594735|144391571|OTHER|||||||0.044|||||||Sign test|Data was not normally distributed||||||0.044
72438872|NCT02594735|144391572|OTHER|||||||0.01|||||||t-test, 2 sided|||||||0.01
72438873|NCT00475319|144391596|SUPERIORITY_OR_OTHER|||||||0.001||95.0||||versus placebo|t-test, 2 sided|a general linear model||||||0.001
72438874|NCT00475319|144391597|SUPERIORITY_OR_OTHER|||||||0.001||95.0||||versus placebo|t-test, 2 sided|a general linear model||||||0.001
72438875|NCT01075217|144391598|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.5|STANDARD_DEVIATION|2.45|<|0.0001|TWO_SIDED|95.0|1.4|3.5||P-value provided is for the difference in pain assessment between Isovue and Visipaque in Group 1, i.e., pain was not assessed separately from heat.|t-test, 2 sided|||||3.5|1.4|<0.0001
72438876|NCT01075217|144391598|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.5|STANDARD_DEVIATION|1.94||0.3244|TWO_SIDED|95.0|-0.5|1.4||P-value provided is for the difference in pain assessment between Isovue and Visipaque in Group 2, i.e., pain was assessed separately from heat.|t-test, 2 sided|||||1.4|-0.5|0.3244
72438877|NCT01075217|144391599|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.6|STANDARD_DEVIATION|2.35||0.0059|TWO_SIDED|95.0|0.5|2.7|||t-test, 2 sided|||||2.7|0.5|0.0059
72438878|NCT00364013|144391631|SUPERIORITY_OR_OTHER_LEGACY||Normal score|-2.27||||0.0234||||||P-value is based on a 2-sided log-rank test stratified by Region (Western Europe, Canada and Australia vs. Rest of World) and ECOG score (0 or 1 vs. 2).|Stratified log-rank test||A normal score \<0 indicates fewer than expected events for the panitumumab plus FOLFOX arm and therefore a longer progression-free survival time.|PFS in the Wild-type KRAS Efficacy Analysis Set was compared at a significance level of 5%.||||0.0234
72438879|NCT00364013|144391631|SUPERIORITY_OR_OTHER_LEGACY||Normal score|2.28||||0.0227||||||P-value is based on a 2-sided log-rank test stratified by Region (Western Europe, Canada and Australia vs. Rest of World) and ECOG score (0 or 1 vs. 2).|Stratified log-rank test||A normal score \<0 indicates fewer than expected events for the panitumumab plus FOLFOX arm and therefore a longer progression-free survival time.|PFS in the Mutant KRAS Efficacy Analysis Set was compared at a significance level of 5% conditional on first demonstrating a significant treatment effect in PFS in the Wild-type KRAS Efficacy Analysis Set.||||0.0227
72438880|NCT00364013|144391632|SUPERIORITY_OR_OTHER_LEGACY||Normal score|-1.8||||0.0723||||||cP-value is based on a 2-sided log-rank test stratified by Region (Western Europe, Canada and Australia vs. Rest of World) and ECOG score (0 or 1 vs. 2).|Stratified log-rank test||A normal score \<0 indicates fewer than expected events for the panitumumab plus FOLFOX arm and therefore a longer overall survival time.|Overall survival comparisons in the wild-type KRAS Efficacy Analysis Set was performed at a significance level of 4.99% conditional on a statistically significant difference for PFS in the Wild-type KRAS Efficacy Analysis Set.||||0.0723
72438881|NCT00364013|144391632|SUPERIORITY_OR_OTHER_LEGACY||Normal score|1.83||||0.0678||||||P-value is based on a 2-sided log-rank test stratified by Region (Western Europe, Canada and Australia vs. Rest of World) and ECOG score (0 or 1 vs. 2).|Stratified log-rank test||A normal score \<0 indicates fewer than expected events for the panitumumab plus FOLFOX arm and therefore a longer overall survival time.|Overall survival comparisons in the mutant KRAS Efficacy Analysis Set was performed at an significance level of 4.99% conditional on a statistically significant difference for PFS in the Mutant KRAS Efficacy Analysis Set.||||0.0678
72495399|NCT02634580|144519797|SUPERIORITY||LS Mean Treatment Difference|3.49|STANDARD_ERROR_OF_MEAN|7.31||0.63|TWO_SIDED|95.0|-11.15|18.13||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Model includes treatment group, stratification factor (screening LDL-C level), scheduled visit and the interaction of treatment with scheduled visit.|Evolocumab - Ezetimibe|||18.13|-11.15|0.63
72438882|NCT00364013|144391633|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.35||||0.0684|TWO_SIDED|95.0|0.98|1.87|||Stratified exact test|Adjusted for geographic region and ECOG score.|The odds ratio is defined as the odds of having an objective response in the panitumumab plus arm relative to the odds on the FOLFOX alone arm.|||1.87|0.98|0.0684
72438883|NCT00364013|144391633|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.98||||0.9822|TWO_SIDED|95.0|0.65|1.47|||Stratified exact test|Adjusted for geographic region and ECOG score|The odds ratio is defined as the odds of having an objective response in the panitumumab plus arm relative to the odds on the FOLFOX alone arm.|||1.47|0.65|0.9822
72438884|NCT03482011|144391665|SUPERIORITY||Risk Difference (RD)|63.0|||<|0.001|TWO_SIDED|95.0|56.5|69.4|||Cochran-Mantel-Haenszel|||||69.4|56.5|<0.001
72438885|NCT03482011|144391666|SUPERIORITY||Risk Difference (RD)|57.8|||<|0.001|TWO_SIDED|95.0|51.3|64.4|||Cochran-Mantel-Haenszel|||||64.4|51.3|<0.001
72438886|NCT03482011|144391667|SUPERIORITY||Risk Difference (RD)|15.6|||<|0.001|TWO_SIDED|95.0|11.6|19.7|||Cochran-Mantel-Haenszel|||||19.7|11.6|<0.001
72438887|NCT03482011|144391668|SUPERIORITY||Risk Difference (RD)|73.6|||<|0.001|TWO_SIDED|95.0|67.1|80.1|||Cochran-Mantel-Haenszel|||||80.1|67.1|<0.001
72438888|NCT03482011|144391669|SUPERIORITY||Risk Difference (RD)|30.8|||<|0.001|TWO_SIDED|95.0|26.0|35.7|||Cochran-Mantel-Haenszel|||||35.7|26.0|<0.001
72438889|NCT03482011|144391670|SUPERIORITY||Risk Difference (RD)|48.1|||<|0.001|TWO_SIDED|95.0|42.9|53.2|||Cochran-Mantel-Haenszel|||||53.2|42.9|<0.001
72438890|NCT03482011|144391671|SUPERIORITY||Risk Difference (RD)|18.3|||<|0.001|TWO_SIDED|95.0|14.5|22.1|||Cochran-Mantel-Haenszel|||||22.1|14.5|<0.001
72438891|NCT03482011|144391672|SUPERIORITY||Risk Difference (RD)|49.6|||<|0.001|TWO_SIDED|95.0|42.8|56.4|||Cochran-Mantel-Haenszel|||||56.4|42.8|<0.001
72438892|NCT03482011|144391673|SUPERIORITY||Risk Difference (RD)|66.7|||<|0.001|TWO_SIDED|95.0|56.0|77.5|||Cochran-Mantel-Haenszel|||||77.5|56.0|<0.001
72438893|NCT03482011|144391673|SUPERIORITY||Risk Difference (RD)|65.9|||<|0.001|TWO_SIDED|95.0|54.9|77.0|||Cochran-Mantel-Haenszel|||||77.0|54.9|<0.001
72438894|NCT03482011|144391674|SUPERIORITY||Mean Difference (Net)|-4.7|STANDARD_ERROR_OF_MEAN|1.32|<|0.001|TWO_SIDED|95.0|-7.31|-2.1|||Mixed Models Analysis|||||-2.10|-7.31|<0.001
72438895|NCT03482011|144391675|SUPERIORITY||Mean Difference (Net)|-17.33|STANDARD_ERROR_OF_MEAN|0.99|<|0.001|TWO_SIDED|95.0|-19.28|-15.39|||Mixed Models Analysis|||||-15.39|-19.28|<0.001
72438896|NCT03482011|144391676|SUPERIORITY||Mean Difference (Net)|-6.98|STANDARD_ERROR_OF_MEAN|1.73|<|0.001|TWO_SIDED|95.0|-10.37|-3.58|||Mixed Models Analysis|||||-3.58|-10.37|<0.001
72386381|NCT02663908|144280666|OTHER||Hazard Ratio (HR)|0.839||||0.718|TWO_SIDED|95.0|0.324|2.176|||Log Rank|The p-value of the log-rank test is based on comparison of the treatment groups stratified for age group and region.|Baseline hazards for the Cox regression were stratified over variables: age group and region.|||2.176|0.324|0.7180
72386382|NCT02663908|144280668|OTHER||Hazard Ratio (HR)|0.887||||0.6701|TWO_SIDED|95.0|0.512|1.539|||Log Rank|The p-value of the log-rank test is based on comparison of the treatment groups stratified for age group and region.|Baseline hazards for the Cox regression were stratified over variables: age group and region.|||1.539|0.512|0.6701
72386383|NCT02663908|144280669|OTHER||Treatment Difference|-0.907||||0.1193|TWO_SIDED|95.0|-2.048|0.235|||ANCOVA|ANCOVA with the baseline score as a covariate, and treatment group, age group, region, visit, and treatment by visit interaction as factors.||IPSS Total at Day 168||0.235|-2.048|0.1193
72386384|NCT02663908|144280669|OTHER||Treatment Difference|-0.213||||0.108|TWO_SIDED|95.0|-0.473|0.047|||ANCOVA|ANCOVA with the baseline score as a covariate, and treatment group, age group, region, visit, and treatment by visit interaction as factors.||IPSS, QoL at Day 168||0.047|-0.473|0.1080
72386385|NCT02663908|144280669|OTHER||Treatment Difference|-0.916||||0.1256|TWO_SIDED|95.0|-2.089|0.257|||ANCOVA|ANCOVA with the baseline score as a covariate, and treatment group, age group, region, visit, and treatment by visit interaction as factors.||IPSS Total at Day 336||0.257|-2.089|0.1256
72386386|NCT02663908|144280669|OTHER||Treatment Difference|-0.047||||0.7261|TWO_SIDED|95.0|-0.312|0.218|||ANCOVA|ANCOVA with the baseline score as a covariate, and treatment group, age group, region, visit, and treatment by visit interaction as factors.||IPSS, QoL at Day 336||0.218|-0.312|0.7261
72386387|NCT02663908|144280673|OTHER||Treatment difference|-0.002||||0.911|TWO_SIDED|95.0|-0.036|0.032|||ANCOVA|Compared using an ANCOVA model, where the QALY is the dependent variable and adjusted for treatment group, age group and region, respectively.||||0.032|-0.036|0.9110
72386388|NCT02663908|144280674|OTHER||Treatment Difference|-1.57||||0.0936|TWO_SIDED|95.0|-3.41|0.27|||ANCOVA|ANCOVA with the baseline score as a covariate, and treatment group, age group, region, visit, and treatment by visit interaction as factors.||DASI at Day 168||0.27|-3.41|0.0936
72386389|NCT02663908|144280674|OTHER||Treatment Difference|0.84||||0.4|TWO_SIDED|95.0|-1.11|2.78|||ANCOVA|ANCOVA with the baseline score as a covariate, and treatment group, age group, region, visit, and treatment by visit interaction as factors.||DASI at Day 336||2.78|-1.11|0.4000
72438897|NCT03482011|144391677|SUPERIORITY||Mean Difference (Net)|4.86|STANDARD_ERROR_OF_MEAN|0.69|<|0.001|TWO_SIDED|95.0|3.5|6.22|||ANCOVA|||||6.22|3.50|<0.001
72386390|NCT02663908|144280675|OTHER||Treatment Difference|0.045||||0.2535|TWO_SIDED|95.0|-0.032|0.122|||ANCOVA|ANCOVA with the baseline score as a covariate, and treatment group, age group, region, visit, and treatment by visit interaction as factors.||CAQ Global Score at Day 168||0.122|-0.032|0.2535
72386391|NCT02663908|144280675|OTHER||Treatment Difference|0.036||||0.437|TWO_SIDED|95.0|-0.055|0.127|||ANCOVA|ANCOVA with the baseline score as a covariate, and treatment group, age group, region, visit, and treatment by visit interaction as factors.||CAQ domain score for Attention at Day 168||0.127|-0.055|0.4370
72386392|NCT02663908|144280675|OTHER||Treatment Difference|0.116||||0.0852|TWO_SIDED|95.0|-0.016|0.248|||ANCOVA|ANCOVA with the baseline score as a covariate, and treatment group, age group, region, visit, and treatment by visit interaction as factors.||CAQ domain score for Avoidance at Day 168||0.248|-0.016|0.0852
72386393|NCT02663908|144280675|OTHER||Treatment Difference|0.012||||0.8156|TWO_SIDED|95.0|-0.087|0.111|||ANCOVA|ANCOVA with the baseline score as a covariate, and treatment group, age group, region, visit, and treatment by visit interaction as factors.||CAQ domain score for Fear at Day 168||0.111|-0.087|0.8156
72386394|NCT02663908|144280675|OTHER||Treatment Difference|0.051||||0.2299|TWO_SIDED|95.0|-0.033|0.135|||ANCOVA|ANCOVA with the baseline score as a covariate, and treatment group, age group, region, visit, and treatment by visit interaction as factors.||CAQ Global Score at Day 336||0.135|-0.033|0.2299
72386395|NCT02663908|144280675|OTHER||Treatment Difference|0.038||||0.444|TWO_SIDED|95.0|-0.06|0.136|||ANCOVA|ANCOVA with the baseline score as a covariate, and treatment group, age group, region, visit, and treatment by visit interaction as factors.||CAQ domain score for Attention at Day 336||0.136|-0.060|0.4440
72386396|NCT02663908|144280675|OTHER||Treatment Difference|0.007||||0.9172|TWO_SIDED|95.0|-0.131|0.146|||ANCOVA|ANCOVA with the baseline score as a covariate, and treatment group, age group, region, visit, and treatment by visit interaction as factors.||CAQ domain score for Avoidance at Day 336||0.146|-0.131|0.9172
72386397|NCT02663908|144280675|OTHER||Treatment Difference|0.093||||0.1028|TWO_SIDED|95.0|-0.019|0.204|||ANCOVA|ANCOVA with the baseline score as a covariate, and treatment group, age group, region, visit, and treatment by visit interaction as factors.||CAQ domain score for Fear at Day 336||0.204|-0.019|0.1028
72386398|NCT00761631|144280690|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|1.5|||||TWO_SIDED|95.0|1.24|1.8||||||Serotype 4: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC Group 4 - 13vPnC Group 3).||1.80|1.24|
72386399|NCT00761631|144280690|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|0.9|||||TWO_SIDED|95.0|0.78|1.15||||||Serotype 6B: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC Group 4 - 13vPnC Group 3).||1.15|0.78|
72386400|NCT00761631|144280690|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|0.9|||||TWO_SIDED|95.0|0.8|1.12||||||Serotype 9V: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC Group 4 - 13vPnC Group 3).||1.12|0.80|
72438898|NCT03482011|144391678|SUPERIORITY||Mean Difference (Net)|4.78|STANDARD_ERROR_OF_MEAN|0.74|<|0.001|TWO_SIDED|95.0|3.33|6.23|||ANCOVA|||||6.23|3.33|<0.001
72438899|NCT03482011|144391679|SUPERIORITY||Risk Difference (RD)|68.1|||<|0.001|TWO_SIDED|95.0|63.2|72.9|||Cochran-Mantel-Haenszel|||||72.9|63.2|<0.001
72438900|NCT03482011|144391680|SUPERIORITY||Mean Difference (Net)|-3.68|STANDARD_ERROR_OF_MEAN|1.84||0.002|TWO_SIDED|95.0|-7.3|-0.06|||ANOVA|||Absenteeism||-0.06|-7.30|0.002
72438901|NCT03482011|144391680|SUPERIORITY||Mean Difference (Net)|-20.24|STANDARD_ERROR_OF_MEAN|2.37|<|0.001|TWO_SIDED|95.0|-24.89|-15.6|||ANCOVA|||Presenteeism||-15.60|-24.89|<0.001
72438902|NCT03482011|144391680|SUPERIORITY||Mean Difference (Net)|-21.09|STANDARD_ERROR_OF_MEAN|2.78|<|0.001|TWO_SIDED|95.0|-26.56|-15.62|||ANCOVA|||Overall Absenteeism and Presenteeism||-15.62|-26.56|<0.001
72438903|NCT03482011|144391680|SUPERIORITY||Mean Difference (Net)|-22.91|STANDARD_ERROR_OF_MEAN|2.28|<|0.001|TWO_SIDED|95.0|-27.39|-18.43|||ANCOVA|||Impairment in Activities Performed Outside of Work||-18.43|-27.39|<0.001
72438904|NCT03482011|144391681|SUPERIORITY||Mean Difference (Net)|0.53|STANDARD_ERROR_OF_MEAN|1.79||0.004|TWO_SIDED|95.0|-3.08|4.14|||ANCOVA|||||4.14|-3.08|0.004
72438905|NCT03482011|144391682|SUPERIORITY||Risk Difference (RD)|48.8|||<|0.001|TWO_SIDED|95.0|41.6|55.9|||Cochran-Mantel-Haenszel|||||55.9|41.6|<0.001
72438906|NCT06243796|144391696|SUPERIORITY||||||<|0.005|||||||t-test, 2 sided|||||||<0.005
72438907|NCT06243796|144391697|SUPERIORITY||||||<|0.05|||||||Fisher Exact|||||||<0.05
72438908|NCT02601170|144391705|SUPERIORITY||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
72438909|NCT00028093|144391712|SUPERIORITY_OR_OTHER|||||||0.54||95.0|||||Wilcoxon (Mann-Whitney)|||Null hypothesis: there is no difference in the outcome between the two groups||||0.54
72438910|NCT03215927|144391723|SUPERIORITY||Median Difference (Net)|-2.55|STANDARD_ERROR_OF_MEAN|3.34|<|0.05|TWO_SIDED|95.0|-9.36|4.26|||Mixed Models Analysis|Adjustments are for baseline FVC, age, and gender, with a repeated measures effect of participant.|The comparison difference value is µABT - µPlacebo.|The null hypothesis for the change outcomes is µABT - µPlacebo = 0.||4.26|-9.36|<0.05
72438911|NCT03215927|144391724|SUPERIORITY||Hazard Ratio (HR)|0.66|STANDARD_ERROR_OF_MEAN|0.73|<|0.05|TWO_SIDED|95.0|0.16|2.77|||Regression, Cox||ABT is the numerator and Placebo is the denominator for the hazard ratios. The dispersion value given is the SE of the estimate on the natural log scale.|The null hypothesis for the time to event outcomes is exp(bABT) / exp(bPlacebo) = 1.||2.77|0.16|<0.05
72438912|NCT03215927|144391725|SUPERIORITY||Mean Difference (Net)|7.51|STANDARD_ERROR_OF_MEAN|8.12|<|0.05|TWO_SIDED|95.0|-8.8|23.83|||Mixed Models Analysis|Adjustments are for baseline FVC, age, and gender, with a repeated measures effect of participant.|The comparison difference value is µABT - µPlacebo.|The null hypothesis for the change outcomes is µABT - µPlacebo = 0.||23.83|-8.80|<0.05
72438913|NCT03215927|144391726|SUPERIORITY||Hazard Ratio (HR)|0.42|STANDARD_ERROR_OF_MEAN|1.16|<|0.05|TWO_SIDED|95.0|0.04|4.02|||Regression, Cox||ABT is the numerator and Placebo is the denominator for the hazard ratios. The dispersion value given is the SE of the estimate on the natural log scale.|The null hypothesis for the time to event outcomes is exp(bABT) / exp(bPlacebo) = 1.||4.02|0.04|<0.05
72438914|NCT02582593|144391727|SUPERIORITY||Cohen's D|0.27||||0.575|TWO_SIDED|||||t = .581, only 1 comparison (2 groups) and thus multiple comparison correction not needed|t-test, 2 sided|||An independent sample t-test was used to examine difference in Pre-post intervention change scores for the Active and Sham groups;. Cohen's d was calculated to determine effect size.||||.575
72438915|NCT02582593|144391728|SUPERIORITY||Cohen's D|1.06||||0.16|TWO_SIDED|||||t = 1.574; only two comparisons, thus not necessary to adjust|t-test, 2 sided|||independent t-test, cohen's d effect size||||.160
72558791|NCT04442503|144647554|SUPERIORITY||LS Mean Difference|-5.7|STANDARD_ERROR_OF_MEAN|2.27||0.0123|TWO_SIDED|95.0|-10.2|-1.3|||MMRM|||Change from Baseline in Anxiety Subscale at Day 15||-1.3|-10.2|0.0123
72438916|NCT02582593|144391729|SUPERIORITY||Cohen's D|0.27||||0.424|TWO_SIDED||||||t-test, 2 sided|||independent t-test, Cohen's d effect size||||.424
72438917|NCT02582593|144391730|SUPERIORITY||Cohen's D|-1.03||||0.099|TWO_SIDED|||||no adjustment necessary, only 1 comparison|t-test, 2 sided|||independent sample t-test, Cohen's d effect size||||0.099
72438918|NCT03073941|144391734|NON_INFERIORITY|A non-Inferiority analysis was performed once the 1 year OKS of the first 216 patients were collected. A one-sided T-test, 90% power, SD=10 and with a non-inferiority margin of 4 OKS was used and the analysis was based on the difference of average OKS between Persona and NexGen 1 year postoperatively.|||||<|0.05|||||||t-test, 1 sided|90% power, SD=10 and with a non-inferiority margin of 4 OKS||||||<0.05
72438919|NCT00304031|144391746|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.03||||0.63|TWO_SIDED|95.0|0.88|1.2||One-sided|Log Rank||Reference level = Conventional adjuvant TMZ|This study was looking for a 20% reduction in hazard rate: null hypothesis (conventional arm): Median survival time (MST) = 14.0 mo.; alternative hypothesis (dose-dense arm): MST= 17.5 mo. A one-sided log-rank test at a significance level of 0.025 would have 80% power to detect this difference with a sample size of 750 patients (647 deaths were required for the final analysis).||1.20|0.88|0.63
72438920|NCT00304031|144391747|SUPERIORITY||Hazard Ratio (HR)|0.87||||0.06|TWO_SIDED|95.0|0.75|1.0||Two-side significance level = 0.05|Log Rank||Reference level = Conventional adjuvant TMZ|||1.00|0.75|0.06
72438921|NCT00304031|144391748|SUPERIORITY||Hazard Ratio (HR)|0.99||||0.44|TWO_SIDED|95.0|0.82|1.19||One-sided significance level = 0.05|Log Rank||Reference level = Conventional adjuvant TMZ|Unmethylated MGMT||1.19|0.82|0.44
72438922|NCT00304031|144391748|SUPERIORITY||Hazard Ratio (HR)|1.19||||0.86|TWO_SIDED|95.0|0.87|1.62||One-sided significance level = 0.05|Log Rank||Reference level = Conventional adjuvant TMZ|Methylated MGMT||1.62|0.87|0.86
72438923|NCT00304031|144391749|SUPERIORITY||Hazard Ratio (HR)|0.88||||0.15|TWO_SIDED|95.0|0.73|1.05||One-sided significance level = 0.05|Log Rank||Reference level = Conventional adjuvant TMZ|Unmethylated MGMT||1.05|0.73|0.15
72438924|NCT00304031|144391749|SUPERIORITY||Hazard Ratio (HR)|0.87||||0.33|TWO_SIDED|95.0|0.66|1.15||One-sided significance level = 0.05|Log Rank||Reference level = Conventional adjuvant TMZ|Methylated MGMT||1.15|0.66|0.33
72438925|NCT00304031|144391750|SUPERIORITY|||||||0.012||||||Two-sided significance level of 0.05|Chi-squared|||||||0.012
72438926|NCT00304031|144391751|SUPERIORITY||||||<|0.001|||||||Chi-squared|Two-sided significance level of 0.05||||||<0.001
72438927|NCT00304031|144391752|SUPERIORITY||||||<|0.001||||||Two-sided test|Log Rank|||||||<0.001
72438928|NCT00304031|144391753|SUPERIORITY|||||||0.96|||||||t-test, 2 sided|||||||0.96
72438929|NCT00304031|144391754|SUPERIORITY|||||||0.73|||||||t-test, 2 sided|||||||0.73
72438930|NCT00304031|144391755|SUPERIORITY|||||||0.57|||||||t-test, 2 sided|||||||0.57
72438931|NCT00304031|144391756|SUPERIORITY|||||||0.78|||||||t-test, 2 sided|||||||0.78
72438932|NCT00304031|144391757|SUPERIORITY|||||||0.24|||||||t-test, 2 sided|||||||0.24
72438933|NCT00304031|144391758|SUPERIORITY|||||||0.74|||||||t-test, 2 sided|||||||0.74
72438934|NCT00304031|144391759|SUPERIORITY|||||||0.79|||||||t-test, 2 sided|||||||0.79
72558792|NCT04442503|144647554|SUPERIORITY||LS Mean Difference|-8.6|STANDARD_ERROR_OF_MEAN|2.96||0.004|TWO_SIDED|95.0|-14.5|-2.8|||MMRM|||Change from Baseline in Bech-6 Subscale at Day 15||-2.8|-14.5|0.0040
72438935|NCT00304031|144391760|SUPERIORITY|||||||0.2184|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept effects are not shown.)||A mixed effects model was run with EORTC QLQ-C30 Global Health Status Score (baseline, 10,12, 22, 24, and 46 weeks) as the outcome of interest. Treatment arm, recursive partitioning analysis (RPA) class, MGMT status, and time were included in the model. Treatment arm is reported here.||||0.2184
72438936|NCT00304031|144391760|SUPERIORITY|||||||0.0763|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept effects are not shown.)||A mixed effects model was run with EORTC QLQ-C30 Global Health Status Score (baseline, 10,12, 22, 24, and 46 weeks) as the outcome of interest. Treatment arm, RPA class, MGMT status, and time were included in the model. RPA class is reported here.||||0.0763
72438937|NCT00304031|144391760|SUPERIORITY|||||||0.5235|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept effects are not shown.)||A mixed effects model was run with EORTC QLQ-C30 Global Health Status Score (baseline, 10,12, 22, 24, and 46 weeks) as the outcome of interest. Treatment arm, RPA class, MGMT status, and time were included in the model. MGMT status is reported here.||||0.5235
72438938|NCT00304031|144391761|SUPERIORITY|||||||0.03|||||||Z-test of two proportions|||||||0.03
72438939|NCT00304031|144391762|SUPERIORITY|||||||0.03|||||||Z-test of two proportions|||||||0.03
72438940|NCT00304031|144391763|SUPERIORITY|||||||0.0002|||||||Chi-squared|Two-sided test||||||0.0002
72438941|NCT00304031|144391764|SUPERIORITY|||||||0.005|||||||Fisher Exact|Two-sided test||||||0.005
72438942|NCT00304031|144391765|SUPERIORITY|||||||0.018|||||||Fisher Exact|Two-sided test||||||0.018
72438943|NCT00304031|144391766|SUPERIORITY|Each explanatory variable is reported separately. (Time and intercept effects are not shown.)||||||0.1702|||||||Mixed Models Analysis|||A mixed effects model was run with MDASI Symptom Severity Score (baseline, 10, 12, 22, 24, 46 weeks) as the outcome of interest. Treatment arm, recursive partitioning analysis (RPA) class, MGMT status, and time were included in the model. Treatment arm is reported here.||||0.1702
72438944|NCT00304031|144391766|SUPERIORITY|||||||0.8159|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept effects are not shown.)||A mixed effects model was run with EORTC QLQ-C30 Global Health Status Score (baseline, 10, 12, 22, 24, 46 weeks) as the outcome of interest. Treatment arm, recursive partitioning analysis (RPA) class, MGMT status, and time were included in the model. RPA is reported here.||||0.8159
72438945|NCT00304031|144391766|SUPERIORITY|||||||0.2174|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept effects are not shown.)||A mixed effects model was run with EORTC QLQ-C30 Global Health Status Score (baseline, 10, 12, 22, 24, 46 weeks) as the outcome of interest. Treatment arm, recursive partitioning analysis (RPA) class, MGMT status, and time were included in the model. MGMT status is reported here.||||0.2174
72438946|NCT00304031|144391767|OTHER|||||||0.023|||||||Regression, Cox|||A Cox proportional hazards model was run with overall survival as the outcome of interest and baseline scores as continuous covariates. The final model was determined from stepwise selection. EORTC physical functioning, EORTC role functioning, standardized HVLT-R recognition, standardized HVLT-R recall, and standardized COWA were included in the initial model. EORTC physical functioning is reported here.||||0.023
72438947|NCT00304031|144391767|OTHER|||||||0.043|||||||Regression, Cox|||A Cox proportional hazards model was run with overall survival as the outcome of interest and baseline scores as continuous covariates. The final model was determined from stepwise selection. EORTC physical functioning, EORTC role functioning, standardized HVLT-R recognition, standardized HVLT-R recall, and standardized COWA were included in the initial model. Standardized HVLT-R recognition is reported here.||||0.043
72558793|NCT04442503|144647554|SUPERIORITY||LS Mean Difference|-7.6|STANDARD_ERROR_OF_MEAN|2.609||0.0041|TWO_SIDED|95.0|-12.7|-2.4|||MMRM|||Change from Baseline in Meier Subscale at Day 15||-2.4|-12.7|0.0041
72558794|NCT04442503|144647556|SUPERIORITY||LS Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|0.649||0.6912|TWO_SIDED|95.0|-1.0|1.5|||MMRM|||Change from Baseline at Day 3||1.5|-1.0|0.6912
72558795|NCT04442503|144647556|SUPERIORITY||LS Mean Difference|-1.8|STANDARD_ERROR_OF_MEAN|0.874||0.041|TWO_SIDED|95.0|-3.5|-0.1|||MMRM|||Change from Baseline at Day 8||-0.1|-3.5|0.0410
72558796|NCT04442503|144647556|SUPERIORITY||LS Mean Difference|-1.9|STANDARD_ERROR_OF_MEAN|0.922||0.0444|TWO_SIDED|95.0|-3.7|0.0|||MMRM|||Change from Baseline at Day 15||0.0|-3.7|0.0444
72438948|NCT00304031|144391767|OTHER|||||||0.021|||||||Regression, Cox|||A Cox proportional hazards model was run with overall survival as the outcome of interest and baseline scores as continuous covariates. The final model was determined from stepwise selection. EORTC physical functioning, EORTC role functioning, standardized HVLT-R recognition, standardized HVLT-R recall, and standardized COWA were included in the initial model. Standardized COWA is reported here.||||0.021
72438949|NCT00304031|144391768|SUPERIORITY|||||||0.2357|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept effects are not shown.)||A mixed effects model was run with NCF Composite Score (baseline, 10, 22, 46 weeks) as the outcome of interest. Treatment arm, recursive partitioning analysis (RPA) class, MGMT status, and time were included in the model. Treatment arm is reported here.||||0.2357
72438950|NCT00304031|144391768|SUPERIORITY|||||||0.0147|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept effects are not shown.)||A mixed effects model was run with NCF Composite Score (baseline, 10, 22, 46 weeks) as the outcome of interest. Treatment arm, recursive partitioning analysis (RPA) class, MGMT status, and time were included in the model. RPA is reported here.||||0.0147
72438951|NCT00304031|144391768|SUPERIORITY|||||||0.457|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept effects are not shown.)||A mixed effects model was run with NCF Composite Score (baseline, 10, 22, 46 weeks) as the outcome of interest. Treatment arm, recursive partitioning analysis (RPA) class, MGMT status, and time were included in the model. MGMT Status is reported here.||||0.457
72438952|NCT00304031|144391769|SUPERIORITY|||||||0.02|||||||Chi-squared|Two-sided test||||||0.02
72438953|NCT00304031|144391770|SUPERIORITY|||||||0.99|||||||Fisher Exact|Two-sided test||||||0.99
72438954|NCT00304031|144391771|SUPERIORITY|||||||0.33|||||||Fisher Exact|Two-sided test||||||0.33
72438955|NCT04250883|144391772|SUPERIORITY|||||||0.54|||||||Chi-squared, Corrected|for age||||||0.54
72438956|NCT04250883|144391773|SUPERIORITY|||||||0.97|||||||Chi-squared, Corrected|for age||||||0.97
72558797|NCT04442503|144647556|SUPERIORITY||LS Mean Difference|-1.6|STANDARD_ERROR_OF_MEAN|0.924||0.0811|TWO_SIDED|95.0|-3.4|0.2|||MMRM|||Change from Baseline at Day 21||0.2|-3.4|0.0811
72558798|NCT04442503|144647556|SUPERIORITY||LS Mean Difference|-1.3|STANDARD_ERROR_OF_MEAN|0.987||0.1846|TWO_SIDED|95.0|-3.3|0.6|||MMRM|||Change from Baseline at Day 28||0.6|-3.3|0.1846
72558799|NCT04442503|144647556|SUPERIORITY||LS Mean Difference|-1.9|STANDARD_ERROR_OF_MEAN|1.031||0.0625|TWO_SIDED|95.0|-4.0|0.1|||MMRM|||Change from Baseline at Day 45||0.1|-4.0|0.0625
72386401|NCT00761631|144280690|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|1.4|||||TWO_SIDED|95.0|1.19|1.76||||||Serotype 14: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC Group 4 - 13vPnC Group 3).||1.76|1.19|
72386402|NCT00761631|144280690|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|0.7|||||TWO_SIDED|95.0|0.59|0.86||||||Serotype 18C: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC Group 4 - 13vPnC Group 3).||0.86|0.59|
72386403|NCT00761631|144280690|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|1.5|||||TWO_SIDED|95.0|1.15|1.86||||||Serotype 19F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC Group 4 - 13vPnC Group 3).||1.86|1.15|
72386404|NCT00761631|144280690|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|1.2|||||TWO_SIDED|95.0|0.97|1.42||||||Serotype 23F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC Group 4 - 13vPnC Group 3).||1.42|0.97|
72386405|NCT00761631|144280690|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|1.7|||||TWO_SIDED|95.0|1.36|2.13||||||Serotype 1: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC Group 4 - 13vPnC Group 3).||2.13|1.36|
72386406|NCT00761631|144280690|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|0.6|||||TWO_SIDED|95.0|0.48|0.67||||||Serotype 3: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC Group 4 - 13vPnC Group 3).||0.67|0.48|
72386407|NCT00761631|144280690|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|0.7|||||TWO_SIDED|95.0|0.53|0.89||||||Serotype 5: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC Group 4 - 13vPnC Group 3).||0.89|0.53|
72386408|NCT00761631|144280690|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|1.3|||||TWO_SIDED|95.0|1.05|1.67||||||Serotype 6A: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC Group 4 - 13vPnC Group 3).||1.67|1.05|
72386409|NCT00761631|144280690|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|0.6|||||TWO_SIDED|95.0|0.53|0.76||||||Serotype 7F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC Group 4 - 13vPnC Group 3).||0.76|0.53|
72438957|NCT04250883|144391775|SUPERIORITY|||||||0.64||||||At 12 days postoperative|Chi-squared, Corrected|for age||||||0.64
72558800|NCT01945580|144647571|NON_INFERIORITY|With type I error of 0.05 and type II error of 0.20 (power 80%), 362 subjects (181 subjects per arm) are needed to detect non-inferiority of transvaginal biologic to native tissue repair, using a margin of 12.0%.|Adjusted Difference in Percentages|0.2|||||TWO_SIDED|90.0|-5.6|5.9|||||The propensity adjusted treatment difference of Xenform transvaginal mesh (TVM) minus NTR was estimated and missing data was handled using multiple imputation method.|||5.9|-5.6|
72386410|NCT00761631|144280690|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|1.1|||||TWO_SIDED|95.0|0.91|1.28||||||Serotype 19A: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC Group 4 - 13vPnC Group 3).||1.28|0.91|
72386411|NCT04508335|144280713|EQUIVALENCE|We use 2, one-sided t-tests, each with alpha set at 0.05 to test the composite null hypothesis that the mean difference score (μReia-μCurrent) between the Reia pessary and baseline (current pessary) on the PFDI-20, is greater than 18.3 (H01), the upper equivalence limit, or lower than -18.3 (H02), the lower equivalence limit.||||||0.0021|||||||t-test, 2 sided|||H01: μReia-μCurrent \> 18.3 and H02: μReia-μCurrent \< -18.3. The alternative hypothesis is thus: HA: -18.3 ≤ μReia-μCurrent ≤ 18.3.||||.0021
72386412|NCT04508335|144280715|OTHER|Mean difference of PFIQ scores. A negative difference (Reia pessary - current pessary) indicates that the PFIQ-7 score improved with the Reia pessary.|Mean Difference (Final Values)|-11.9||||0.0192|TWO_SIDED|||||p value adjusted for multiple variables|Wilcoxon (Mann-Whitney)|||PFIQ scores at baseline with subjects using current pessary then after treatment with Reia pessary||||0.0192
72386413|NCT03080454|144280736|EQUIVALENCE|Statistical analysis for mean percent change from baseline in area under the curve for the resistance torque measure across 2 conditions (anodal vs. sham Doublestim) and at 2 timepoints (final session at day 5 and 1 week FU). Null hypothesis is that there was no difference in mean percent change in area under the curve between anodal and sham Doublestim conditions. A significance level of 0.05 was used (two-sided).||||||0.004||||||A 2x2 repeated measures ANOVA was performed with condition (mean percent change in anodal vs. sham condition) and time (final session at day 5 and 1 week FU in each condition) as factors. A significance level of 0.05 was used (two-sided).|ANOVA|||||||0.004
72438958|NCT04250883|144391775|SUPERIORITY|||||||0.38||||||At 3 months postoperative|Chi-squared, Corrected|for age||||||0.38
72438959|NCT04250883|144391776|SUPERIORITY|||||||0.84|||||||Chi-squared, Corrected|For age||Count of patients with or without pain at 3 months postoperative||||0.84
72438960|NCT04250883|144391776|SUPERIORITY|||||||0.89|||||||ANCOVA|Correction for age||Number of Words Chosen||||0.89
72438961|NCT04250883|144391776|SUPERIORITY|||||||0.98|||||||ANCOVA|Correction for age||Pain Rating index||||0.98
72438962|NCT04250883|144391777|SUPERIORITY|||||||0.9|||||||ANCOVA|Correction for age||||||0.9
72438963|NCT04250883|144391778|SUPERIORITY|||||||0.68|||||||ANCOVA|Correction for age||At 1 hour||||0.68
72438964|NCT04250883|144391778|SUPERIORITY|||||||0.91|||||||ANCOVA|Correction for age||At 6 hours||||0.91
72438965|NCT04250883|144391778|SUPERIORITY|||||||0.73|||||||ANCOVA|Correction for age||||||0.73
72438966|NCT04250883|144391778|SUPERIORITY|||||||0.77|||||||ANCOVA|Correction for age||||||0.77
72438967|NCT04250883|144391779|SUPERIORITY|||||||0.63|||||||ANCOVA|Correction for age||At 1 hour||||0.63
72438968|NCT04250883|144391779|SUPERIORITY|||||||0.19|||||||ANCOVA|Correction for age||At postoperative day 1||||0.19
72438969|NCT04250883|144391780|SUPERIORITY|||||||0.89|||||||ANCOVA|Correction for age||At 1 hour||||0.89
72438970|NCT04250883|144391780|SUPERIORITY|||||||0.49|||||||ANCOVA|Correction for age||At postoperative day 1||||0.49
72438971|NCT04250883|144391781|SUPERIORITY|||||||0.42|||||||ANCOVA|Correction for age||||||0.42
72438972|NCT04250883|144391782|SUPERIORITY|||||||0.92|||||||ANCOVA|Correction for age||Of Total complications within 30 days postoperative||||0.92
72438973|NCT04250883|144391783|SUPERIORITY|||||||0.098|||||||ANCOVA|correction for age||Time to maximal intensity||||0.098
72438974|NCT04250883|144391783|SUPERIORITY|||||||0.008|||||||ANCOVA|correction for age||Angle from minimal to maximal intensity||||0.008
72438975|NCT04250883|144391783|SUPERIORITY|||||||0.042|||||||ANCOVA|correction for age||Delta between minimal and maximal intensity||||0.042
72558801|NCT01945580|144647572|NON_INFERIORITY|With type I error of 0.05 and type II error of 0.10 (power 90%), 308 subjects (154 subjects per arm) are needed to detect non-inferiority with a margin of 11.6%.|Adjusted Difference in Percentages|2.0|||||TWO_SIDED|90.0|-0.8|4.7|||||The propensity score adjusted difference in SAE rate of Xenform transvaginal mesh (TVM) vs. NTR was estimated.|||4.7|-0.8|
72438976|NCT04250883|144391784|SUPERIORITY|||||||0.35|||||||ANCOVA|Correction for age||postoperative day 1||||0.35
72438977|NCT04250883|144391784|SUPERIORITY|||||||0.52|||||||ANCOVA|Correction for age||at postoperative day 12||||0.52
72438978|NCT04250883|144391785|SUPERIORITY|||||||0.99|||||||ANCOVA|correction for age||at postoperative day 1||||0.99
72438979|NCT04250883|144391785|SUPERIORITY|||||||0.3|||||||ANCOVA|Correction for age||At postoperative day 12||||0.30
72438980|NCT04250883|144391786|SUPERIORITY|||||||0.42|||||||ANCOVA|Correction for age||||||0.42
72438981|NCT04250883|144391787|SUPERIORITY|||||||0.3|||||||ANCOVA|Correction for age||||||0.3
72438982|NCT04250883|144391788|SUPERIORITY|||||||0.33|||||||ANCOVA|Correction for age||||||0.33
72438983|NCT04250883|144391789|SUPERIORITY|||||||0.018|||||||ANCOVA|Correction for age||||||0.018
72438984|NCT00722046|144391885|SUPERIORITY||Least Squares (LS) Mean Difference|1.38|STANDARD_ERROR_OF_MEAN|3.04||0.6504|TWO_SIDED|90.0|-3.68|6.45|||Mixed Models Analysis|||Mixed model repeated measures used terms for treatment, visit, baseline value, country, and treatment-by-visit interaction, with unstructured covariance matrix.||6.45|-3.68|0.6504
72438985|NCT00722046|144391885|SUPERIORITY||LS Mean Difference|2.02|STANDARD_ERROR_OF_MEAN|3.13||0.5213|TWO_SIDED|90.0|-3.2|7.23|||Mixed Models Analysis|||Mixed model repeated measures used terms for treatment, visit, baseline value, country, and treatment-by-visit interaction, with unstructured covariance matrix.||7.23|-3.20|0.5213
72438986|NCT00722046|144391885|SUPERIORITY||LS Mean Difference|2.27|STANDARD_ERROR_OF_MEAN|3.13||0.4698|TWO_SIDED|90.0|-2.94|7.48|||Mixed Models Analysis|||Mixed model repeated measures used terms for treatment, visit, baseline value, country, and treatment-by-visit interaction, with unstructured covariance matrix.||7.48|-2.94|0.4698
72438987|NCT00722046|144391885|SUPERIORITY||LS Mean Difference|1.73|STANDARD_ERROR_OF_MEAN|2.66||0.5183|TWO_SIDED|90.0|-2.71|6.17|||Mixed Models Analysis|||Mixed model repeated measures used terms for treatment, visit, baseline value, country, and treatment-by-visit interaction, with unstructured covariance matrix.||6.17|-2.71|0.5183
72438988|NCT00722046|144391885|SUPERIORITY||LS Mean Difference|0.85|STANDARD_ERROR_OF_MEAN|2.7||0.7529|TWO_SIDED|90.0|-3.65|5.35|||Mixed Models Analysis|||Mixed model repeated measures used terms for treatment, visit, baseline value, country, and treatment-by-visit interaction, with unstructured covariance matrix.||5.35|-3.65|0.7529
72438989|NCT00722046|144391887|SUPERIORITY||LS Mean Difference|-4.07|STANDARD_ERROR_OF_MEAN|5.59||0.4688|TWO_SIDED|90.0|-13.38|5.24|||Mixed Models Analysis|||Mixed model repeated measures used terms for treatment, visit, baseline value, country, and treatment-by-visit interaction, with unstructured covariance matrix.||5.24|-13.38|0.4688
72438990|NCT00722046|144391887|SUPERIORITY||LS Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|5.64||0.9743|TWO_SIDED|90.0|-9.59|9.22|||Mixed Models Analysis|||Mixed model repeated measures used terms for treatment, visit, baseline value, country, and treatment-by-visit interaction, with unstructured covariance matrix.||9.22|-9.59|0.9743
72438991|NCT00722046|144391887|SUPERIORITY||LS Mean Difference|0.84|STANDARD_ERROR_OF_MEAN|5.65||0.8824|TWO_SIDED|90.0|-8.57|10.25|||Mixed Models Analysis|||Mixed model repeated measures used terms for treatment, visit, baseline value, country, and treatment-by-visit interaction, with unstructured covariance matrix.||10.25|-8.57|0.8824
72438992|NCT00722046|144391887|SUPERIORITY||LS Mean Difference|-4.09|STANDARD_ERROR_OF_MEAN|5.81||0.4831|TWO_SIDED|90.0|-13.77|5.58|||Mixed Models Analysis|||Mixed model repeated measures used terms for treatment, visit, baseline value, country, and treatment-by-visit interaction, with unstructured covariance matrix.||5.58|-13.77|0.4831
72438993|NCT00722046|144391887|SUPERIORITY||LS Mean Difference|0.32|STANDARD_ERROR_OF_MEAN|5.88||0.9562|TWO_SIDED|90.0|-9.48|10.13|||Mixed Models Analysis|||Mixed model repeated measures used terms for treatment, visit, baseline value, country, and treatment-by-visit interaction, with unstructured covariance matrix.||10.13|-9.48|0.9562
72438994|NCT02731755|144391897|SUPERIORITY|||||||0.5|||||||Mixed Models Analysis|||Between time points and treatments, calculated p value||||0.5
72438995|NCT02731755|144391898|SUPERIORITY|||||||0.04|||||||Mixed Models Analysis|||Ach-iAUC||||0.04
72438996|NCT02731755|144391898|SUPERIORITY|||||||0.007|||||||Mixed Models Analysis|||SNP-IAUC||||0.007
72438997|NCT02731755|144391898|SUPERIORITY|||||||0.02|||||||Mixed Models Analysis|||Ach - AUC||||0.02
72438998|NCT02731755|144391899|SUPERIORITY|||||||0.9|||||||Mixed Models Analysis|||||||0.9
72438999|NCT02731755|144391901|SUPERIORITY|||||||0.7|||||||Mixed Models Analysis|||||||0.7
72558802|NCT00989950|144647613|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.34|STANDARD_DEVIATION|14.0||0.588|TWO_SIDED|95.0|0.0|233.0|||ANOVA|||||233|0|0.588
72386414|NCT03080454|144280737|EQUIVALENCE|Statistical analysis for mean Tardieu Scale Score summed across 11 joints of the upper extremity in 2 conditions (anodal vs. sham Doublestim) and at 2 timepoints (final session at day 5 and 1 week FU). Null hypothesis is that there was no difference in mean change between anodal and sham Doubleestim conditions. A significance level of 0.05 was used (two-sided).||||||0.003||||||A 2x2 repeated measures ANOVA was performed with condition (mean score in anodal vs. sham condition) and time (final session at day 5 and 1 week FU in each condition) as factors. A significance level of 0.05 was used (two-sided).|ANOVA|||||||0.003
72386415|NCT00216476|144280738|SUPERIORITY_OR_OTHER||||||<|0.0001||||||threshold for significance: 0.05 (2-sided)|Log Rank|||Null hypothesis was that there is no difference in treatment effect between risperidone LAI and quetiapine by mean relapse free period; given a estimated relapse rate of 30% for risperidone LAI and 42% for quetiapine, with 80% power and 5% 2-tailed significance level, 251 subjects were needed per treatment arm. To adjust for an estimated 20% discontinuations for reasons other than relapse, 628 subjects in total were needed. Actual relapse rates were 17% (risperidone LAI) and 31% (quetiapine).||||<0.0001
72386416|NCT00216476|144280740|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|95.0||||The statistical test was interpreted at the 5% significance level.|Wilcoxon (Mann-Whitney)|||Between-group comparison of the change from baseline to endpoint in total PANSS score. The endpoint of the study was based on the Last Observation Carried Forward (LOCF) principle, i.e., it was defined as the last available visit during the study with non-missing data for a parameter (excluding the baseline value).||||<0.0001
72386417|NCT00216476|144280740|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|95.0||||The statistical test was interpreted at the 5% significance level.|Wilcoxon signed-rank test|||Within-group comparison of the change from baseline to endpoint in total PANSS score. The endpoint of the study was based on the LOCF principle.||||<0.0001
72386418|NCT00216476|144280740|SUPERIORITY_OR_OTHER|||||||0.1026|TWO_SIDED|95.0||||The statistical test was interpreted at the 5% significance level.|Wilcoxon signed-rank test|||Within-group comparison of the change from baseline to endpoint in total PANSS score. The endpoint of the study was based on the LOCF principle.||||0.1026
72386419|NCT00216476|144280741|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|95.0||||The statistical test was interpreted at the 5% significance level.|Wilcoxon (Mann-Whitney)|||Between-group comparison of the change from baseline to endpoint in CGI-S score. The endpoint of the study was based on the LOCF principle.||||<0.0001
72386420|NCT00216476|144280741|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|95.0||||The statistical test was interpreted at the 5% significance level.|Wilcoxon signed-rank test|||Within-group comparison of the change from baseline to endpoint in CGI-S score. The endpoint of the study was based on the LOCF principle.||||<0.0001
72386421|NCT00216476|144280741|SUPERIORITY_OR_OTHER|||||||0.0446|TWO_SIDED|95.0||||The statistical test was interpreted at the 5% significance level.|Wilcoxon signed-rank test|||Within-group comparison of the change from baseline to endpoint in CGI-S score. The endpoint of the study was based on the LOCF principle.||||0.0446
72386422|NCT00216476|144280742|SUPERIORITY_OR_OTHER|||||||0.0941|TWO_SIDED|95.0||||The statistical test was interpreted at the 5% significance level.|Wilcoxon (Mann-Whitney)|||Between-group comparison of the change from baseline to endpoint in PCS score. The endpoint of the study was based on the LOCF principle.||||0.0941
72386423|NCT00216476|144280742|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|95.0||||The statistical test was interpreted at the 5% significance level.|Wilcoxon signed-rank test|||Within-group comparison of the change from baseline to endpoint in PCS score. The endpoint of the study was based on the LOCF principle.||||<0.0001
72386424|NCT00216476|144280742|SUPERIORITY_OR_OTHER|||||||0.1146|TWO_SIDED|95.0||||The statistical test was interpreted at the 5% significance level.|Wilcoxon signed-rank test|||Within-group comparison of the change from baseline to endpoint in PCS score. The endpoint of the study was based on the LOCF principle.||||0.1146
72386425|NCT00216476|144280742|SUPERIORITY_OR_OTHER|||||||0.5589|TWO_SIDED|95.0||||The statistical test was interpreted at the 5% significance level.|Wilcoxon (Mann-Whitney)|||Between-group comparison of the change from baseline to endpoint in MCS score. The endpoint of the study was based on the LOCF principle.||||0.5589
72558803|NCT00101439|144647614|SUPERIORITY_OR_OTHER_LEGACY||Geometric Mean Ratio (GMR)|0.89||||0.241|TWO_SIDED|95.0|0.73|1.08||Data were back-transformed from the log scale and adjusted for treatment|ANOVA||GMR=Ezetimibe divided by placebo|||1.08|0.73|0.241
72558804|NCT00101439|144647615|SUPERIORITY_OR_OTHER_LEGACY||Geometric Mean Ratio (GMR)|1.02||||0.812|TWO_SIDED|95.0|0.87|1.2||Data were back-transformed from the log scale and adjusted for treatment|ANOVA||GMR=Ezetimibe divided by placebo|||1.20|0.87|0.812
72618892|NCT01260324|144768304|SUPERIORITY_OR_OTHER_LEGACY||Incidence rate per 1000 person-years|0.05|||||TWO_SIDED|95.0|0.04|0.06|||||Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.|Incidence rate Northeast||0.06|0.04|
72618893|NCT01260324|144768304|SUPERIORITY_OR_OTHER_LEGACY||Incidence rate per 1000 person-years|0.05|||||TWO_SIDED|95.0|0.04|0.05|||||Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.|Incidence rate Midwest||0.05|0.04|
72386426|NCT00216476|144280742|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|95.0||||The statistical test was interpreted at the 5% significance level.|Wilcoxon signed-rank test|||Within-group comparison of the change from baseline to endpoint in MCS score. The endpoint of the study was based on the LOCF principle.||||<0.0001
72386427|NCT00216476|144280742|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|95.0||||The statistical test was interpreted at the 5% significance level.|Wilcoxon signed-rank test|||Within-group comparison of the change from baseline to endpoint in MCS score. The endpoint of the study was based on the LOCF principle.||||<0.0001
72386428|NCT00696800|144280743|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Treatment groups were formally compared with a generalized linear model for the ongoing pregnancy rate which included factors for treatment group, age at randomization, and region. A pre-defined non-inferiority margin of 8% was applied.|Risk Difference (RD)|1.1|||||TWO_SIDED|95.0|-3.8|5.9||||||||5.9|-3.8|
72386429|NCT00696800|144280744|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Equivalence margins of -3 and +5 were applied for the difference in number of oocytes. If the 95% confidence interval of the difference exceeded -3 or +5 oocytes, then Corifollitropin Alfa treatment was not considered equivalent to the reference treatment (recFSH).|Mean Difference (Final Values)|1.2||||0.001|TWO_SIDED|95.0|0.5|1.9||Treatment groups were formally compared including covariates treatment group, age and center.|ANOVA|||||1.9|0.5|0.001
72386430|NCT02298023|144280773|OTHER|||||||0.35|||||||Kruskal-Wallis|||Null hypothesis: There is no difference between the three groups. Statistical power: 0.80||||0.35
72386431|NCT02298023|144280774|EQUIVALENCE|To test whether there were differences in the rate of change among groups||||||0.662|||||||Mixed Models Analysis|||||||0.662
72618894|NCT01260324|144768304|SUPERIORITY_OR_OTHER_LEGACY||Incidence rate per 1000 person-years|0.05|||||TWO_SIDED|95.0|0.05|0.06|||||Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.|Incidence rate South||0.06|0.05|
72386432|NCT02298023|144280775|EQUIVALENCE|To test whether there were differences in the rate of change among groups||||||0.882|||||||Mixed Models Analysis|||||||0.882
72386433|NCT02298023|144280776|EQUIVALENCE|To test whether there were differences in the rate of change among groups||||||0.835|||||||Mixed Models Analysis|||||||0.835
72386434|NCT02298023|144280777|EQUIVALENCE|To test whether there were differences in the rate of change among groups||||||0.977|||||||Mixed Models Analysis|||||||0.977
72386435|NCT02298023|144280778|EQUIVALENCE|To test whether there were differences in the rate of change among groups||||||0.867|||||||Mixed Models Analysis|||||||0.867
72386436|NCT02298023|144280779|EQUIVALENCE|To test whether there were differences in the change of tear size among groups||||||0.916|||||||Chi-squared|||||||0.916
72386437|NCT02298023|144280780|EQUIVALENCE|To test whether there were differences in the change of tear size among groups||||||0.892|||||||Chi-squared|||||||0.892
72386438|NCT01967173|144280797|SUPERIORITY|||||||0.003|||||||Mixed Models Analysis|||Test of the null hypothesis that the superiority of Advair 100/50 compared to Fluticasone 250 is equal to the inferiority of Advair 100/50 compared to Fluticasone 250||||0.003
72386439|NCT01967173|144280797|SUPERIORITY|||||||0.9|||||||Mixed Models Analysis|||Test of the null hypothesis that the superiority of Advair 100/50 compared to Fluticasone 250 is equal to the inferiority of Advair 100/50 compared to Fluticasone 250||||0.9
72386440|NCT01967173|144280797|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||Test of the null hypothesis that the superiority of Advair 100/50 compared to Fluticasone 500 is equal to the inferiority of Advair 100/50 compared to Fluticasone 500||||<0.001
72386441|NCT01967173|144280797|SUPERIORITY|||||||0.42|||||||Mixed Models Analysis|||Test of the null hypothesis that the superiority of Advair 100/50 compared to Advair 250/50 is equal to the inferiority of Advair 100/50 compared to Advair 250/50||||0.42
72386442|NCT01967173|144280797|SUPERIORITY|||||||0.84|||||||Mixed Models Analysis|||Test of the null hypothesis that the superiority of Advair 100/50 compared to Advair 250/50 is equal to the inferiority of Advair 100/50 compared to Advair 250/50||||0.84
72386443|NCT01967173|144280797|SUPERIORITY|||||||0.015|||||||Mixed Models Analysis|||Test of the null hypothesis that the superiority of Advair 250/50 compared to Fluticasone 500 is equal to the inferiority of Advair 250/50 compared to Fluticasone 500||||0.015
72386444|NCT01967173|144280797|SUPERIORITY|||||||0.085|||||||Mixed Models Analysis|||Test of the null hypothesis that the superiority of Advair 250/50 compared to Fluticasone 250 is equal to the inferiority of Advair 250/50 compared to Fluticasone 250||||0.085
72386445|NCT01967173|144280797|SUPERIORITY|||||||0.62|||||||Mixed Models Analysis|||Test of the null hypothesis that the superiority of Advair 250/50 compared to Fluticasone 250 is equal to the inferiority of Advair 250/50 compared to Fluticasone 250||||0.62
72386446|NCT01967173|144280797|SUPERIORITY|||||||0.48|||||||Mixed Models Analysis|||Test of the null hypothesis that the superiority of Fluticasone 500 compared to Fluticasone 250 is equal to the inferiority of Fluticasone 500 compared to Fluticasone 250||||0.48
72386447|NCT01967173|144280797|SUPERIORITY|||||||0.14|||||||Mixed Models Analysis|||Test of the null hypothesis that the superiority of Advair 100/50 compared to Fluticasone 100 is equal to the inferiority of Advair 100/50 compared to Fluticasone 100||||0.14
72386448|NCT01967173|144280797|SUPERIORITY|||||||0.096|||||||Mixed Models Analysis|||Test of the null hypothesis that the superiority of Fluticasone 250 compared to Fluticasone 100 is equal to the inferiority of Fluticasone 250 compared to Fluticasone 100||||0.096
72395147|NCT02730455|144296817|SUPERIORITY|||||||0.049|||||||Cochran-Armitage trend test|||BI: The Cochran-Armitage trend test of a monotonically increasing dose response in proportion of excellent outcome. Dose levels are log transformed.||||0.049
72395148|NCT02480439|144296825|SUPERIORITY_OR_OTHER||Point Estimate|0.966|||||TWO_SIDED|90.0|0.8747|1.0668|||||Relative Bioavailability A/B. The point estimates and 90% CIs were obtained from the exponentiated results of the analysis of the natural logarithm-transformed data.|||1.0668|0.8747|
72395149|NCT02480439|144296825|SUPERIORITY_OR_OTHER||Point Estimate|0.9223|||||TWO_SIDED|90.0|0.8352|1.0185|||||Relative Bioavailability B/C. The point estimates and 90% CIs were obtained from the exponentiated results of the analysis of the natural logarithm-transformed data.|||1.0185|0.8352|
72395150|NCT02480439|144296826|SUPERIORITY_OR_OTHER||Point Estimate|0.9998|||||TWO_SIDED|90.0|0.954|1.0477|||||Relative Bioavailability A/B. The point estimates and 90% CIs were obtained from the exponentiated results of the analysis of the natural logarithm-transformed data.|||1.0477|0.9540|
72395151|NCT02480439|144296826|SUPERIORITY_OR_OTHER||Point Estimate|1.0149|||||TWO_SIDED|90.0|0.9685|1.0636|||||Relative Bioavailability B/C. The point estimates and 90% CIs were obtained from the exponentiated results of the analysis of the natural logarithm-transformed data.|||1.0636|0.9685|
72395152|NCT02480439|144296827|SUPERIORITY_OR_OTHER||Point Estimate|0.9992|||||TWO_SIDED|90.0|0.9541|1.0464|||||Relative Bioavailability A/B. The point estimates and 90% CIs were obtained from the exponentiated results of the analysis of the natural logarithm-transformed data.|||1.0464|0.9541|
72395153|NCT02480439|144296827|SUPERIORITY_OR_OTHER||Point Estimate|1.0134|||||TWO_SIDED|90.0|0.9676|1.0612|||||Relative Bioavailability B/C. The point estimates and 90% CIs were obtained from the exponentiated results of the analysis of the natural logarithm-transformed data.|||1.0612|0.9676|
72395154|NCT02268084|144296831|SUPERIORITY|||||||0.007|||||||ANOVA|||Null hypothesis is that the active treatment group does not differ from the sham group in changes in the PCL-M total scores.||||.007
72395155|NCT02268084|144296832|SUPERIORITY|||||||0.326|||||||t-test, 2 sided|||||||.326
72395156|NCT02725710|144296858|OTHER|||||||0.56|||||||Regression, Linear|||||||0.56
72395157|NCT03978520|144296910|SUPERIORITY||Response Rate Difference|12.8|||=|0.081|TWO_SIDED|95.0|-1.6|27.1|||Cochran-Mantel-Haenszel|||"ABBV-599 High Dose (Elsubrutinib 60 mg/upadacitinib 30 mg) vs elsubrutinib placebo/upadacitinib placebo~The difference between the groups was assessed using the Cochran-Mantel-Haenszel (CMH) test, stratified by baseline corticosteroid dose above 10 mg prednisone-equivalent (≤10 mg or \> 10 mg), screening SLEDAI-2K (\< 10 or ≥10), baseline interferon score (high or low or NA), baseline immunosuppressant (azathioprine, tacrolimus, cyclosporine, methotrexate \[MTX\], mycophenolate) (yes or no)."||27.1|-1.6|=0.081
72439000|NCT01149369|144391909|NON_INFERIORITY_OR_EQUIVALENCE|P-values, relative risk ratios, and 95% confidence limits (CI) for the primary ITT were calculated using the Cochran-Mantel-Haenszel chi-square test, stratified by clinic.|Risk Ratio (RR)|1.2||||0.43|TWO_SIDED|95.0|0.8|1.7|||Cochran-Mantel-Haenszel|Stratified by clinic||Either 1) improvement in mean of available nausea VAS scores over 28-day treatment period compared to means of VAS during the 7-day baseline (BL) period being ≤ -25 mm, or 2) mean VAS after 28-days of treatment was \< 25 mm.||1.7|0.8|0.43
72439001|NCT01149369|144391910|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-1.5||||0.03|TWO_SIDED|95.0|-2.8|-0.1|||ANCOVA|||||-0.1|-2.8|0.03
72439002|NCT01149369|144391911|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.01||||0.94|TWO_SIDED|95.0|-0.3|0.3|||ANCOVA|||||0.3|-0.3|0.94
72439003|NCT01149369|144391912|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|0.1||||0.73|TWO_SIDED|95.0|-0.4|0.6|||ANCOVA|||||0.6|-0.4|0.73
72439004|NCT01149369|144391913|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.2||||0.22|TWO_SIDED|95.0|-0.4|0.1|||ANCOVA|||||0.1|-0.4|0.22
72439005|NCT01149369|144391914|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.3||||0.06|TWO_SIDED|95.0|-0.6|0.0|||ANCOVA|||||0.0|-0.6|0.06
72439006|NCT01149369|144391915|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.1||||0.24|TWO_SIDED|95.0|-0.3|0.1|||ANCOVA|||||0.1|-0.3|0.24
72439007|NCT01149369|144391916|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.4||||0.01|TWO_SIDED|95.0|-0.7|-0.1|||ANCOVA|||||-0.1|-0.7|0.01
72439008|NCT01149369|144391917|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.2||||0.22|TWO_SIDED|95.0|-0.4|0.1|||ANCOVA|||||0.1|-0.4|0.22
72439009|NCT01149369|144391918|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.03||||0.51|TWO_SIDED|95.0|-0.1|0.1|||ANCOVA|||||0.1|-0.1|0.51
72439010|NCT01149369|144391919|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.2||||0.12|TWO_SIDED|95.0|-0.5|0.1|||ANCOVA|||||0.1|-0.5|0.12
72439011|NCT01149369|144391920|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.3||||0.02|TWO_SIDED|95.0|-0.6|-0.1|||ANCOVA|||||-0.1|-0.6|0.02
72439012|NCT01149369|144391921|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|0.3||||0.17|TWO_SIDED|95.0|-0.1|0.7|||ANCOVA|||||0.7|-0.1|0.17
72439013|NCT01149369|144391922|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|2.6||||0.59|TWO_SIDED|95.0|-7.0|12.2|||ANCOVA|||||12.2|-7.0|0.59
72618895|NCT01260324|144768304|SUPERIORITY_OR_OTHER_LEGACY||Incidence rate per 1000 person-years|0.04|||||TWO_SIDED|95.0|0.04|0.05|||||Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.|Incidence rate West||0.05|0.04|
72439014|NCT01149369|144391923|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|2.1||||0.61|TWO_SIDED|95.0|-5.9|10.0|||ANCOVA|||||10.0|-5.9|0.61
72439015|NCT01149369|144391924|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|0.1||||0.23|TWO_SIDED|95.0|-0.1|0.2|||ANCOVA|||||0.2|-0.1|0.23
72439016|NCT01149369|144391925|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|0.0||||0.97|TWO_SIDED|95.0|-0.5|0.5|||ANCOVA|||||0.5|-0.5|0.97
72439017|NCT01149369|144391926|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|3.1||||0.77|TWO_SIDED|95.0|-18.0|24.2|||ANCOVA|||||24.2|-18.0|0.77
72439018|NCT01149369|144391927|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.1||||0.46|TWO_SIDED|95.0|-0.2|0.1|||ANCOVA|||||0.1|-0.2|0.46
72386449|NCT02002832|144280818|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|LS mean for the treatment difference(lurasidone-risperidone) at week 6 and its 95% confidence interval was presented based on the MMRM. Non-inferiority for lurasidone relative to risperidone was evaluated by comparing the upper bound of the 95% confidence interval to the non-inferiority margin of 7.0. Plots of estimates for change from baseline in PANSS total score based on MMRM over time (Week 1 to Week 6) with 95% confidence intervals was provided for each treatment group.|Mean Difference (Final Values)|3.7|STANDARD_ERROR_OF_MEAN|1.37|||TWO_SIDED|95.0|1.0|6.3|||Mixed Models Analysis|||||6.3|1.0|
72386450|NCT00492531|144281059|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-9.0||||0.7|TWO_SIDED|95.0|-56.0|38.0|||ANCOVA|6 minute walk was based on ANCOVA model with treatment as a fixed effect and 6 minute walk distance, TRV stratum and study site as covariate.||||38|-56|0.70
72386451|NCT03685123|144281070|SUPERIORITY|||||||0.256|||||||Mixed Models Analysis|||||||0.256
72386452|NCT03685123|144281071|SUPERIORITY|||||||0.089|||||||Mixed Models Analysis|||||||0.089
72386453|NCT03685123|144281072|SUPERIORITY|||||||0.244|||||||Mixed Models Analysis|||||||0.244
72386454|NCT03685123|144281073|SUPERIORITY|||||||0.064|||||||Mixed Models Analysis|||||||0.064
72386455|NCT03685123|144281074|SUPERIORITY|||||||0.983|||||||Mixed Models Analysis|||LDL levels||||0.983
72386456|NCT03685123|144281074|SUPERIORITY|||||||0.56|||||||Mixed Models Analysis|||HDL levels||||0.56
72386457|NCT03685123|144281074|SUPERIORITY|||||||0.71|||||||Mixed Models Analysis|||Total Cholesterol||||0.71
72386458|NCT03685123|144281074|SUPERIORITY|||||||0.313|||||||Mixed Models Analysis|||Triglycerides||||0.313
72386459|NCT03685123|144281075|SUPERIORITY|||||||0.72|||||||Mixed Models Analysis|||systolic Blood pressure||||0.72
72386460|NCT03685123|144281075|SUPERIORITY|||||||0.61|||||||Mixed Models Analysis|||Diastolic Blood pressure||||0.61
72386461|NCT03685123|144281075|SUPERIORITY|||||||0.1609|||||||Mixed Models Analysis|||Change in aortic blood pressure between the PA-REC and the WM-REC Groups.||||0.1609
72386462|NCT03685123|144281075|SUPERIORITY|||||||0.446|||||||Mixed Models Analysis|||Change in aortic diastolic blood pressure between the PA-REC and WM-REC Groups||||0.446
72386463|NCT03685123|144281076|SUPERIORITY|||||||0.965|||||||Mixed Models Analysis|||||||0.965
72386464|NCT03685123|144281077|SUPERIORITY|||||||0.857|||||||Mixed Models Analysis|||||||0.857
72386465|NCT03685123|144281078|SUPERIORITY|||||||0.825|||||||Mixed Models Analysis|||||||0.825
72386466|NCT03685123|144281079|SUPERIORITY|||||||0.061|||||||Mixed Models Analysis|||||||0.061
72386467|NCT03685123|144281081|SUPERIORITY|Change in particle size between the PA-REC and WM-REC groups||||||0.105|||||||Mixed Models Analysis|||Change in HDL particle size||||0.105
72386468|NCT03685123|144281081|SUPERIORITY|Change in particle size between the PA-REC and the WM-REC groups||||||0.849|||||||Mixed Models Analysis|||Change in LDL particles||||0.849
72386469|NCT03685123|144281083|SUPERIORITY|||||||0.278|||||||ANOVA|||Change in steps per day from week 10 to week 28||||0.278
72386470|NCT03685123|144281084|SUPERIORITY|||||||0.238|||||||Mixed Models Analysis|||Change in SF-36 General Health (GH)||||0.238
72386471|NCT03685123|144281084|SUPERIORITY|Between groups analysis between the change in PA-REC Group vs. the WM-REC Group||||||0.124|||||||Mixed Models Analysis|||Change in SF-36 Physical health (PH)||||0.124
72386472|NCT03685123|144281084|SUPERIORITY|Between groups analysis between the change in PA-REC Group vs. the WM-REC Group||||||0.769|||||||Mixed Models Analysis|||Change in SF-36 role physical||||0.769
72386473|NCT03685123|144281084|SUPERIORITY|Between groups analysis between the change in PA-REC Group vs. the WM-REC Group||||||0.352|||||||Mixed Models Analysis|||Change in SF-36 Bodily Pain||||0.352
72386474|NCT03685123|144281084|SUPERIORITY|Between groups analysis between the change in PA-REC Group vs. the WM-REC Group||||||0.898|||||||Mixed Models Analysis|||Change in SF-36 Vitality||||0.898
72386475|NCT03685123|144281084|SUPERIORITY|Between groups analysis between the change in PA-REC Group vs. the WM-REC Group||||||0.444|||||||Mixed Models Analysis|||Change in SF-36 social function||||0.444
72386476|NCT03685123|144281084|SUPERIORITY|Change between the PA-REC group and the WM-REC group||||||0.537|||||||Mixed Models Analysis|||Change in SF-36 Mental Health||||0.537
72386477|NCT03685123|144281084|SUPERIORITY|||||||0.448|||||||Mixed Models Analysis|||Change in SF-36 Role Emotional||||0.448
72386478|NCT03685123|144281084|SUPERIORITY|Change between the PA-REC group and the WM-REC group||||||0.537|||||||Mixed Models Analysis|||Change in SF-36 Mental Health (Sum)||||0.537
72386479|NCT03685123|144281084|SUPERIORITY|Change between the PA-REC group and the WM-REC group||||||0.482|||||||Mixed Models Analysis|||Change in SF-36 Physical Health (sum)||||0.482
72386480|NCT03685123|144281086|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
72386481|NCT03685123|144281087|SUPERIORITY|||||||0.37|||||||Mixed Models Analysis|||||||0.37
72386482|NCT03685123|144281088|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||Change in body fat||||<0.001
72386483|NCT03685123|144281089|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
72386484|NCT03685123|144281090|SUPERIORITY|||||||0.004|||||||Mixed Models Analysis|||LDL||||0.004
72386485|NCT03685123|144281090|SUPERIORITY|||||||0.04|||||||Mixed Models Analysis|||Change in HDL||||0.04
72386486|NCT03685123|144281090|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||Change in Total Cholesterol||||<0.001
72386487|NCT03685123|144281090|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||Triglycerides||||<0.001
72386488|NCT03685123|144281091|SUPERIORITY|||||||0.01||||||Systolic blood pressure|Mixed Models Analysis|||||||0.01
72386489|NCT03685123|144281091|SUPERIORITY|||||||0.001|||||||Mixed Models Analysis|||Diastolic blood pressure||||0.001
72386490|NCT03685123|144281091|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||Aortic blood pressure (mmHg)||||<0.001
72386491|NCT03685123|144281091|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||Change in aortic diastolic pressure||||<0.001
72386492|NCT03685123|144281092|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
72386493|NCT03685123|144281093|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
72386494|NCT03685123|144281094|SUPERIORITY|||||||0.366|||||||Mixed Models Analysis|||||||0.366
72386495|NCT03685123|144281095|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
72386496|NCT03685123|144281097|SUPERIORITY|||||||0.004|||||||Mixed Models Analysis|||||||0.004
72386497|NCT03685123|144281098|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
72386498|NCT03685123|144281099|SUPERIORITY||||||<|0.001||||||General Health|Mixed Models Analysis|||||||<0.001
72495400|NCT02634580|144519798|SUPERIORITY||LS Mean Treatment Difference|11.79|STANDARD_ERROR_OF_MEAN|9.52||0.22|TWO_SIDED|95.0|-7.29|30.87||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Model includes treatment group, stratification factor (screening LDL-C level), scheduled visit and the interaction of treatment with scheduled visit.|Evolocumab - Ezetimibe|||30.87|-7.29|0.22
72495401|NCT02634580|144519799|SUPERIORITY||LS Mean Treatment Difference|7.96|STANDARD_ERROR_OF_MEAN|3.08||0.012|TWO_SIDED|95.0|1.78|14.14||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Model includes treatment group, stratification factor (screening LDL-C level), scheduled visit and the interaction of treatment with scheduled visit.|Evolocumab - Ezetimibe|||14.14|1.78|0.012
72495402|NCT02634580|144519800|SUPERIORITY||LS Mean Treatment Difference|5.59|STANDARD_ERROR_OF_MEAN|3.2||0.086|TWO_SIDED|95.0|-0.82|12.0||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Model includes treatment group, stratification factor (screening LDL-C level), scheduled visit and the interaction of treatment with scheduled visit.|Evolocumab - Ezetimibe|||12.00|-0.82|0.086
72495403|NCT02634580|144519801|SUPERIORITY||LS Mean Treatment Difference|-0.67|STANDARD_ERROR_OF_MEAN|7.26||0.93|TWO_SIDED|95.0|-15.22|13.87||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Model includes treatment group, stratification factor (screening LDL-C level), scheduled visit and the interaction of treatment with scheduled visit.|Evolocumab - Ezetimibe|||13.87|-15.22|0.93
72495404|NCT02634580|144519802|SUPERIORITY||LS Mean Treatment Difference|7.64|STANDARD_ERROR_OF_MEAN|9.88||0.44|TWO_SIDED|95.0|-12.15|27.43||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Model includes treatment group, stratification factor (screening LDL-C level), scheduled visit and the interaction of treatment with scheduled visit.|Evolocumab - Ezetimibe|||27.43|-12.15|0.44
72495405|NCT00997516|144519837|SUPERIORITY_OR_OTHER|||||||0.01||||||Significant at p\<0.05|Wilcoxon (Mann-Whitney)|||||||0.01
72495406|NCT00997516|144519838|SUPERIORITY_OR_OTHER||||||<|0.01||||||Significant at p\<0.05|t-test, 2 sided|||||||<0.01
72495407|NCT00997516|144519847|SUPERIORITY_OR_OTHER|||||||0.86||||||Significant at p\<0.05|Wilcoxon (Mann-Whitney)|||Overall body satisfaction||||0.86
72495408|NCT00997516|144519847|SUPERIORITY_OR_OTHER|||||||0.18||||||Significant at p\<0.05|Wilcoxon (Mann-Whitney)|||Damage to body||||0.18
72618896|NCT01260324|144768304|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.41|||||TWO_SIDED|95.0|0.31|0.56|||||Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.|Odds ratio Northeast||0.56|0.31|
72618897|NCT01260324|144768304|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.68|||||TWO_SIDED|95.0|0.56|0.84|||||Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.|Odds ratio Midwest||0.84|0.56|
72618898|NCT01260324|144768304|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.73|||||TWO_SIDED|95.0|0.57|0.93|||||Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.|Odds ratio West||0.93|0.57|
72495409|NCT00997516|144519847|SUPERIORITY_OR_OTHER|||||||0.04||||||Significant at p\<0.05|Wilcoxon (Mann-Whitney)|||Physical attractiveness||||0.04
72495410|NCT00997516|144519847|SUPERIORITY_OR_OTHER|||||||0.34||||||Significant at p\<0.05|Wilcoxon (Mann-Whitney)|||Masculinity/femininity||||0.34
72495411|NCT00997516|144519847|SUPERIORITY_OR_OTHER|||||||0.63||||||Significant at p\<0.05|Wilcoxon (Mann-Whitney)|||Looking at oneself naked||||0.63
72495412|NCT00997516|144519848|SUPERIORITY_OR_OTHER|||||||0.48||||||Significant at p\<0.05|t-test, 2 sided|||Cosmetic appearance of abdomen||||0.48
72495413|NCT00997516|144519848|SUPERIORITY_OR_OTHER|||||||0.09||||||Significant at p\<0.05|t-test, 2 sided|||Cosmetic appearance of scars||||0.09
72495414|NCT00997516|144519848|SUPERIORITY_OR_OTHER|||||||0.25||||||Significant at p\<0.05|t-test, 2 sided|||Satisfaction with scars||||0.25
72495415|NCT00997516|144519848|SUPERIORITY_OR_OTHER|||||||0.81||||||Significant at p\<0.05|t-test, 2 sided|||Discomfort of scars||||0.81
72495416|NCT00997516|144519848|SUPERIORITY_OR_OTHER||||||<|0.01||||||Significant at p\<0.05|t-test, 2 sided|||Overall impression of scars||||<0.01
72495417|NCT00584233|144519849|NON_INFERIORITY|The statistical test will be to assess non-inferiority. The non-inferiority margin is -0.04 in AUC. Key parameters are the number of participating patients, the number of radiologists reading the images in the study. Power analysis was conducted using the standard simulation from the ROC literature (Roe and Metz, Academic Radiology 1997). With a total of 100 participating patients and 4 participating readers, we achieve a power \>80% with a non-inferiority margin of -0.04.|Obuchowski Rockette methodology|0.05||||0.05|TWO_SIDED|95.0|0.025|0.975|||Obuchowski Rockette|||The analysis is intended to evaluate non-inferiority in observer performance between CE-bCT and CE-bMRI as assessed by the area under the ROC curve (AUC). The null hypothesis is that the observed difference in average AUC for CE-bCT and CE-bMRI will be outside of a non-inferiority margin of -0.04. See below for details of the power analyses.||.975|.025|0.05
72495418|NCT01340209|144519883|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.012|STANDARD_ERROR_OF_MEAN|0.048||0.7971|TWO_SIDED|95.0|-0.082|0.106|||Mixed Models Analysis|adjusted for treatment, week, baseline, treatment\*week and baseline\*week||Difference calculated as Tiotropium 2.5 µg minus placebo||0.106|-0.082|0.7971
72495419|NCT01340209|144519883|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.112|STANDARD_ERROR_OF_MEAN|0.048||0.0203|TWO_SIDED|95.0|0.018|0.207|||Mixed Models Analysis|adjusted for treatment, week, baseline, treatment\*week and baseline\*week||Difference calculated as Tiotropium 5 μg minus placebo||0.207|0.018|0.0203
72495420|NCT01340209|144519884|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.037|STANDARD_ERROR_OF_MEAN|0.053||0.4944|TWO_SIDED|95.0|-0.141|0.068|||Mixed Models Analysis|adjusted for treatment, week, baseline, treatment\*week and baseline\*week||Difference calculated as Tiotropium 2.5 µg minus placebo||0.068|-0.141|0.4944
72495421|NCT01340209|144519884|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.082|STANDARD_ERROR_OF_MEAN|0.054||0.127|TWO_SIDED|95.0|-0.023|0.188|||Mixed Models Analysis|adjusted for treatment, week, baseline, treatment\*week and baseline\*week||Difference calculated as Tiotropium 5 μg minus placebo||0.188|-0.023|0.1270
72618899|NCT01260324|144768305|SUPERIORITY_OR_OTHER_LEGACY||Incidence rate per 1000 person-years|0.09|||||TWO_SIDED|95.0|0.08|0.1|||||Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.|Incidence rate Diabetes||0.10|0.08|
72439019|NCT01149369|144391928|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|0.1||||0.44|TWO_SIDED|95.0|-0.2|0.4|||ANCOVA|||||0.4|-0.2|0.44
72439020|NCT01149369|144391929|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|0.1||||0.77|TWO_SIDED|95.0|-0.7|0.9|||ANCOVA|||||0.9|-0.7|0.77
72439021|NCT01149369|144391930|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.1||||0.8|TWO_SIDED|95.0|-0.6|0.5|||ANCOVA|||||0.5|-0.6|0.80
72439022|NCT01149369|144391931|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|0.0||||0.88|TWO_SIDED|95.0|-0.1|0.1|||ANCOVA|||||0.1|-0.1|0.88
72439023|NCT01149369|144391932|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-10.9||||0.17|TWO_SIDED|95.0|-26.5|4.7|||ANCOVA|||||4.7|-26.5|0.17
72439024|NCT01149369|144391933|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.7||||0.07|TWO_SIDED|95.0|-1.5|0.0|||ANCOVA|||||0.0|-1.5|0.07
72439025|NCT01149369|144391934|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|0.3||||0.53|TWO_SIDED|95.0|-0.7|1.3|||ANCOVA|||||1.3|-0.7|0.53
72439026|NCT01149369|144391935|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|0.0||||0.93|TWO_SIDED|95.0|-0.9|1.0|||ANCOVA|||||1.0|-0.9|0.93
72439027|NCT01149369|144391936|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|0.0||||0.52|TWO_SIDED|95.0|-1.0|0.2|||ANCOVA|||||0.2|-1.0|0.52
72439028|NCT01149369|144391937|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|0.0||||0.76|TWO_SIDED|95.0|-0.1|0.1|||ANCOVA|||||0.1|-0.1|0.76
72439029|NCT01149369|144391938|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.5||||0.45|TWO_SIDED|95.0|-2.0|0.9|||ANCOVA|||||0.9|-2.0|0.45
72439030|NCT01149369|144391939|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|0.0||||0.18|TWO_SIDED|95.0|0.0|0.1|||ANCOVA|||||0.1|0.0|0.18
72439031|NCT01149369|144391940|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.1||||0.008|TWO_SIDED|95.0|-0.2|0.0|||ANCOVA|||||-0|-0.2|0.008
72439032|NCT01149369|144391941|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.6||||0.001|TWO_SIDED|95.0|-0.9|-0.3|||ANCOVA|||||-0.3|-0.9|0.001
72439033|NCT01149369|144391942|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.8|||<|0.001|TWO_SIDED|95.0|-1.2|-0.4|||ANCOVA|||||-0.4|-1.2|<0.001
72439034|NCT01149369|144391943|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.3||||0.13|TWO_SIDED|95.0|-0.7|0.1|||ANCOVA|||||0.1|-0.7|0.13
72439035|NCT01149369|144391944|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.6||||0.004|TWO_SIDED|95.0|-1.2|-0.2|||ANCOVA|||||-0.2|-1.2|0.004
72439036|NCT01149369|144391945|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.4||||0.08|TWO_SIDED|95.0|-0.9|0.1|||ANCOVA|||||0.1|-0.9|0.08
72439037|NCT01149369|144391946|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.5||||0.007|TWO_SIDED|95.0|-0.8|-0.1|||ANCOVA|||||-0.1|-0.8|0.007
72439038|NCT01149369|144391947|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.7||||0.005|TWO_SIDED|95.0|-1.3|-0.2|||ANCOVA|||||-0.2|-1.3|0.005
72618900|NCT01260324|144768305|SUPERIORITY_OR_OTHER_LEGACY||Incidence rate per 1000 person-years|0.11|||||TWO_SIDED|95.0|0.08|0.14|||||Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.|Incidence rate Smoking||0.14|0.08|
72386499|NCT03685123|144281099|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||Physical Health||||<0.001
72386500|NCT03685123|144281099|SUPERIORITY|||||||0.023|||||||Mixed Models Analysis|||Role physical||||0.023
72386501|NCT03685123|144281099|SUPERIORITY||||||<|0.001||||||Bodily Pain|Mixed Models Analysis|||||||<0.001
72386502|NCT03685123|144281099|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||Vitality||||<0.001
72386503|NCT03685123|144281099|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||Social Functioning||||<0.001
72386504|NCT03685123|144281099|SUPERIORITY|||||||0.0105|||||||Mixed Models Analysis|||Mental Health||||0.0105
72386505|NCT03685123|144281099|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||Role Emotional||||<0.001
72386506|NCT03685123|144281099|SUPERIORITY|||||||0.01|||||||Mixed Models Analysis|||SF-36 mental health Components (sum)||||0.01
72386507|NCT03685123|144281099|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||Physical Health Components Sum||||<0.001
72386508|NCT03685123|144281100|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||Change in kilocalories consumed from baseline to week 10||||<0.001
72386509|NCT03685123|144281101|SUPERIORITY|||||||0.658|||||||Mixed Models Analysis|||Change in LDL Particle Size||||0.658
72386510|NCT03685123|144281101|SUPERIORITY|||||||0.07|||||||Mixed Models Analysis|||HDL participle size||||0.07
72386511|NCT02628938|144281114|SUPERIORITY_OR_OTHER|||||||0.299|||||||t-test, 2 sided|||Paired t-test was performed to examine the significance of change in Organoleptic scores after 15 minutes of the first use of Miswak extract mouth wash||||0.299
72386512|NCT02628938|144281114|SUPERIORITY_OR_OTHER|||||||0.007|||||||t-test, 2 sided|||Paired t-test was performed to examine the significance of change in Organoleptic scores after 7 days of using Miswak extract mouth wash||||0.007
72386513|NCT02628938|144281114|SUPERIORITY_OR_OTHER|||||||0.019|||||||t-test, 2 sided|||Paired t-test was performed to examine the significance of change in Organoleptic scores after 15 minutes of the first use of Miswak sticks||||0.019
72386514|NCT02628938|144281114|SUPERIORITY_OR_OTHER|||||||0|||||||t-test, 2 sided|||Paired t-test was performed to examine the significance of change in Organoleptic scores after 7 days of using Miswak sticks||||0.000
72386515|NCT02628938|144281114|SUPERIORITY_OR_OTHER|||||||0|||||||t-test, 2 sided|||Paired t-test was performed to examine the significance of change in Organoleptic scores after 15 minutes of the first use of Chlorohexidine gluconate mouth wash||||0.000
72386516|NCT02628938|144281114|SUPERIORITY_OR_OTHER|||||||0.001|||||||t-test, 2 sided|||Paired t-test was performed to examine the significance of change in Organoleptic scores after 7 days of using Chlorohexidine gluconate mouth wash||||0.001
72386517|NCT02628938|144281115|SUPERIORITY_OR_OTHER|||||||0.496|||||||t-test, 2 sided|||Paired t-test was performed to examine the significance of change in Volatile sulfur compound scores after 15 minutes of the first use of Miswak extract mouth wash||||0.496
72386518|NCT02628938|144281115|SUPERIORITY_OR_OTHER|||||||0.244|||||||t-test, 2 sided|||Paired t-test was performed to examine the significance of change in Volatile sulfur compound scores after 7 days of using Miswak extract mouth wash||||0.244
72386519|NCT02628938|144281115|SUPERIORITY_OR_OTHER|||||||0.19|||||||t-test, 2 sided|||Paired t-test was performed to examine the significance of change in Volatile sulfur compound scores after 15 minutes of the first use of Miswak sticks||||0.19
72386520|NCT02628938|144281115|SUPERIORITY_OR_OTHER|||||||0.829|||||||t-test, 2 sided|||Paired t-test was performed to examine the significance of change in Volatile sulfur compound scores after 7 days of of using Miswak sticks||||0.829
72386521|NCT02628938|144281115|SUPERIORITY_OR_OTHER|||||||0.341|||||||t-test, 2 sided|||Paired t-test was performed to examine the significance of change in Volatile sulfur compound scores after 15 minutes of the first use of Chlorohexidine gluconate mouth wash||||0.341
72386522|NCT02628938|144281115|SUPERIORITY_OR_OTHER|||||||0.82|||||||t-test, 2 sided|||Paired t-test was performed to examine the significance of change in Volatile sulfur compound scores after 7 days of using Chlorohexidine gluconate mouth wash||||0.82
72386523|NCT02628938|144281116|SUPERIORITY_OR_OTHER|||||||0.008|||||||t-test, 2 sided|||Paired t-test was performed to examine the significance of change in Self-assessment scores after 7 days of using Miswak extract mouth wash||||0.008
72386524|NCT02628938|144281116|SUPERIORITY_OR_OTHER|||||||0.001|||||||t-test, 2 sided|||Paired t-test was performed to examine the significance of change in Self-assessment scores after 7 days of using Miswak sticks||||0.001
72386525|NCT02628938|144281116|SUPERIORITY_OR_OTHER|||||||0.02|||||||t-test, 2 sided|||Paired t-test was performed to examine the significance of change in Self-assessment scores after 7 days of using Chlorohexidine gluconate mouth wash||||0.02
72386526|NCT00843856|144281136|SUPERIORITY|||||||0.7|||||||Fisher Exact|||||||0.7
72386527|NCT01893203|144281138|SUPERIORITY_OR_OTHER|||||||0.375|||||||McNemar|||||||0.375
72386528|NCT00621959|144281142|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.14||||0.546||95.0|-0.59|0.31||If the p-value of this estimated difference is lower than 5% the mean T5SS is considered as different between the two treatment groups.|ANCOVA|ANCOVA including treatment and center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis for the primary endpoint is expressed as follows: 'The mean 24-hr reflective T5SS over the total treatment period is not different from subjects treated with levocetirizine than subjects treated with placebo.'||0.31|-0.59|0.546
72439039|NCT01149369|144391948|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.7||||0.001|TWO_SIDED|95.0|-1.1|-0.3|||ANCOVA|||||-0.3|-1.1|0.001
72618901|NCT01260324|144768305|SUPERIORITY_OR_OTHER_LEGACY||Incidence rate per 1000 person-years|0.04|||||TWO_SIDED|95.0|0.03|0.06|||||Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.|Incidence rate Obesity||0.06|0.03|
72618902|NCT01260324|144768305|SUPERIORITY_OR_OTHER_LEGACY||Incidence rate per 1000 person-years|0.07|||||TWO_SIDED|95.0|0.06|0.09|||||Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.|Incidence rate Nitrates||0.09|0.06|
72439040|NCT01149369|144391949|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.8||||0.003|TWO_SIDED|95.0|-2.3|-0.3|||ANCOVA|||||-0.3|-2.3|0.003
72439041|NCT01149369|144391950|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.5||||0.03|TWO_SIDED|95.0|-1.0|-0.1|||ANCOVA|||||-0.1|-1.0|0.03
72439042|NCT01149369|144391951|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.3||||0.16|TWO_SIDED|95.0|-0.8|0.1|||ANCOVA|||||0.1|-0.8|0.16
72439043|NCT01149369|144391952|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.5||||0.05|TWO_SIDED|95.0|-0.9|0.0|||ANCOVA|||||0.0|-0.9|0.05
72439044|NCT01149369|144391953|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|0.1||||0.72|TWO_SIDED|95.0|-0.4|0.6|||ANCOVA|||||0.6|-0.4|0.72
72439045|NCT01149369|144391954|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.8||||0.001|TWO_SIDED|95.0|-1.2|-0.3|||ANCOVA|||||-0.3|-1.2|0.001
72439046|NCT01149369|144391955|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.5||||0.04|TWO_SIDED|95.0|-0.9|0.0|||ANCOVA|||||0.0|-0.9|0.04
72439047|NCT01149369|144391956|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.4||||0.14|TWO_SIDED|95.0|-0.9|0.1|||ANCOVA|||||0.1|-0.9|0.14
72439048|NCT01149369|144391957|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.5||||0.07|TWO_SIDED|95.0|-1.0|0.0|||ANCOVA|||||0.0|-1.0|0.07
72439049|NCT01149369|144391958|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.3||||0.19|TWO_SIDED|95.0|-0.8|0.2|||ANCOVA|||||0.2|-0.8|0.19
72439050|NCT01149369|144391959|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.5||||0.04|TWO_SIDED|95.0|-0.9|0.0|||ANCOVA|||||-0.0|-0.9|0.04
72439051|NCT01149369|144391960|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.5||||0.02|TWO_SIDED|95.0|-1.0|-0.1|||ANCOVA|||||-0.1|-1.0|0.02
72439052|NCT01149369|144391961|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.4||||0.06|TWO_SIDED|95.0|-0.9|0.0|||ANCOVA|||||0.0|-0.9|0.06
72439053|NCT01149369|144391962|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.4||||0.09|TWO_SIDED|95.0|-0.8|0.1|||ANCOVA|||||0.1|-0.8|0.09
72618903|NCT01260324|144768305|SUPERIORITY_OR_OTHER_LEGACY||Incidence rate per 1000 person-years|0.15|||||TWO_SIDED|95.0|0.12|0.18|||||Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.|Incidence rate Anti-platelet agents||0.18|0.12|
72439054|NCT01149369|144391963|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.3||||0.17|TWO_SIDED|95.0|-7.0|0.1|||ANCOVA|||||0.1|-7|0.17
72439055|NCT01149369|144391964|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.6||||0.009|TWO_SIDED|95.0|-1.1|-0.2|||ANCOVA|||||-0.2|-1.1|0.009
72439056|NCT01149369|144391965|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.7||||0.004|TWO_SIDED|95.0|-1.2|-0.2|||ANCOVA|||||-0.2|-1.2|0.004
72439057|NCT01149369|144391966|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.4||||0.1|TWO_SIDED|95.0|-0.8|0.1|||ANCOVA|||||0.1|-0.8|0.10
72439058|NCT01149369|144391967|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.4||||0.13|TWO_SIDED|95.0|-0.9|0.1|||ANCOVA|||||0.1|-0.9|0.13
72439059|NCT01149369|144391968|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.01||||0.98|TWO_SIDED|95.0|-0.5|0.4|||ANCOVA|||||0.4|-0.5|0.98
72439060|NCT01149369|144391969|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.4||||0.007|TWO_SIDED|95.0|-0.7|0.1|||ANCOVA|||||0.1|-0.7|0.007
72439061|NCT01149369|144391970|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.5||||0.06|TWO_SIDED|95.0|-0.9|0.0|||ANCOVA|||||0.0|-0.9|0.06
72439062|NCT01149369|144391971|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.6||||0.001|TWO_SIDED|95.0|-1.0|-0.2|||ANCOVA|||||-0.2|-1.0|0.001
72386529|NCT00621959|144281143|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.08||||0.442||95.0|-0.27|0.12||If the p-value of this estimated difference is lower than 5% the mean change from baseline in overall RQLQ score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the change from baseline in overall RQLQ score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean change from baseline in overall RQLQ score at endpoint visit is not different from subjects treated with levocetirizine than subjects treated with placebo.'||0.12|-0.27|0.442
72386530|NCT01758523|144281144|OTHER|||||||0.002|||||||Mixed Models Analysis|||||||0.002
72386531|NCT01758523|144281145|OTHER|||||||0.028|||||||Mixed Models Analysis|||||||0.028
72386532|NCT01758523|144281146|OTHER||Odds Ratio (OR)|2.49||||0.057|TWO_SIDED|95.0|0.96|6.45|||Chi-squared|||||6.45|0.96|0.057
72386533|NCT01758523|144281147|OTHER||Odds Ratio (OR)|5.5||||0.007|TWO_SIDED|95.0|1.5|20.7|||Fisher Exact|||||20.7|1.5|0.007
72386534|NCT01758523|144281148|OTHER|||||||0.87||||||significance for drug x AKR1C3\*2 G-carrier genotype|Mixed Models Analysis|||||||0.87
72386535|NCT01758523|144281149|OTHER|||||||0.03|||||||t-test, 2 sided|||||||0.030
72386536|NCT04729621|144281155|EQUIVALENCE|Biosimilarity will be demonstrated if the 95% CI for the difference falls entirely within the equivalence margin of (-1.45, +1.45).|Mean Difference (Net)|0.21|||||TWO_SIDED|95.0|-0.73|1.15||||||LS means, differences and confidence intervals (CI) from the ANCOVA model with percent change from baseline to Week 52 in LS-BMD as the outcome, treatment group, region and previous use of bisphosphates as fixed effects, baseline LS-BMD and baseline weight as covariates. Missing outcomes imputed using multiple imputation methods under the MAR assumption.||1.15|-0.73|
72386537|NCT04729621|144281156|EQUIVALENCE|Biosimilarity will be demonstrated if the 95% CI for the difference falls entirely within the equivalence margin of (-20, +20).|Mean Difference (Net)|9.07|||||TWO_SIDED|95.0|-0.14|18.29||||||LS means, differences and confidence intervals (CI) from the ANCOVA model with percent change from baseline to Week 26 in sCTX-1 as the outcome, treatment group, region and previous use of bisphosphates as fixed effects, baseline sCTX-1 and baseline weight as covariates. Missing outcomes are not imputed. Results below the limit of quantification (BLQ) are imputed as the low limit of quantification (LLOQ = 0.033 ng/mL).||18.29|-0.14|
72386538|NCT03439657|144281181|NON_INFERIORITY|Upper limit (UL) of the 95% confidence interval (CI) for the anti-gE antibodies Geometric Mean Concentration (GMC) ratio between the Control group and the Co-Ad group should be \<1.5.|GMC ratio|1.07|||||TWO_SIDED|95.0|0.99|1.16|||ANCOVA|The 95% CI of the group GMCs ratio was computed using an Analysis Of Covariance (ANCOVA) model on the log10 transformation of the concentrations.||Anti-gE GMCs (non-inferiority): Non-inferiority comparison between Control Group and Co-Ad Group in terms of geometric mean concentrations (GMCs) for anti-gE antibodies, one month after the administration of last vaccine dose.||1.16|0.99|
72386539|NCT03439657|144281182|NON_INFERIORITY|Upper limit (UL) of 95% CI for each individual pneumococcal conjugate serotype Geometric Mean Titer (GMT) ratio of the Control group over the Co-Ad group should be \<2.|GMT ratio|1.04|||||TWO_SIDED|95.0|0.82|1.33|||ANCOVA|The 95% CI of the group MOPA GMT ratios was computed using an Analysis Of Covariance (ANCOVA) model on the log10 transformation of the concentrations.||Anti-pneumococcal antibody titers (non-inferiority): Non-inferiority comparison between Control Group and Co-Ad Group in terms of geometric mean titers (GMTs) for anti-pneumococcal antibody (MOPA-1), one month after the administration of Prevnar 13 vaccine dose.||1.33|0.82|
72386540|NCT03439657|144281182|NON_INFERIORITY|Upper limit (UL) of 95% CI for each individual pneumococcal conjugate serotype Geometric Mean Titer (GMT) ratio of the Control group over the Co-Ad group should be \<2.|GMT ratio|1.02|||||TWO_SIDED|95.0|0.86|1.22|||ANCOVA|The 95% CI of the group MOPA GMT ratios was computed using an Analysis Of Covariance (ANCOVA) model on the log10 transformation of the concentrations.||Anti-pneumococcal antibody titers (non-inferiority): Non-inferiority comparison between Control Group and Co-Ad Group in terms of geometric mean titers (GMTs) for anti-pneumococcal antibody (MOPA-3), one month after the administration of Prevnar 13 vaccine dose.||1.22|0.86|
72386541|NCT03439657|144281182|NON_INFERIORITY|Upper limit (UL) of 95% CI for each individual pneumococcal conjugate serotype Geometric Mean Titer (GMT) ratio of the Control group over the Co-Ad group should be \<2.|GMT ratio|1.25|||||TWO_SIDED|95.0|1.02|1.52|||ANCOVA|The 95% CI of the group MOPA GMT ratios was computed using an Analysis Of Covariance (ANCOVA) model on the log10 transformation of the concentrations.||Anti-pneumococcal antibody titers (non-inferiority): Non-inferiority comparison between Control Group and Co-Ad Group in terms of geometric mean titers (GMTs) for anti-pneumococcal antibody (MOPA-4), one month after the administration of Prevnar 13 vaccine dose.||1.52|1.02|
72439063|NCT01149369|144391972|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.2||||0.28|TWO_SIDED|95.0|-0.6|0.2|||ANCOVA|||||0.2|-0.6|0.28
72618904|NCT01260324|144768305|SUPERIORITY_OR_OTHER_LEGACY||Incidence rate per 1000 person-years|0.13|||||TWO_SIDED|95.0|0.09|0.17|||||Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.|Incidence rate Diuretics||0.17|0.09|
72386542|NCT03439657|144281182|NON_INFERIORITY|Upper limit (UL) of 95% CI for each individual pneumococcal conjugate serotype Geometric Mean Titer (GMT) ratio of the Control group over the Co-Ad group should be \<2.|GMT ratio|1.04|||||TWO_SIDED|95.0|0.81|1.32|||ANCOVA|The 95% CI of the group MOPA GMT ratios was computed using an Analysis Of Covariance (ANCOVA) model on the log10 transformation of the concentrations.||Anti-pneumococcal antibody titers (non-inferiority): Non-inferiority comparison between Control Group and Co-Ad Group in terms of geometric mean titers (GMTs) for anti-pneumococcal antibody (MOPA-5), one month after the administration of Prevnar 13 vaccine dose.||1.32|0.81|
72386543|NCT03439657|144281182|NON_INFERIORITY|Upper limit (UL) of 95% CI for each individual pneumococcal conjugate serotype Geometric Mean Titer (GMT) ratio of the Control group over the Co-Ad group should be \<2.|GMT ratio|1.26|||||TWO_SIDED|95.0|1.02|1.56|||ANCOVA|The 95% CI of the group MOPA GMT ratios was computed using an Analysis Of Covariance (ANCOVA) model on the log10 transformation of the concentrations.||Anti-pneumococcal antibody titers (non-inferiority): Non-inferiority comparison between Control Group and Co-Ad Group in terms of geometric mean titers (GMTs) for anti-pneumococcal antibody (MOPA-6A), one month after the administration of Prevnar 13 vaccine dose.||1.56|1.02|
72386544|NCT03439657|144281182|NON_INFERIORITY|Upper limit (UL) of 95% CI for each individual pneumococcal conjugate serotype Geometric Mean Titer (GMT) ratio of the Control group over the Co-Ad group should be \<2.|GMT ratio|1.36|||||TWO_SIDED|95.0|1.07|1.73|||ANCOVA|The 95% CI of the group MOPA GMT ratios was computed using an Analysis Of Covariance (ANCOVA) model on the log10 transformation of the concentrations.||Anti-pneumococcal antibody titers (non-inferiority): Non-inferiority comparison between Control Group and Co-Ad Group in terms of geometric mean titers (GMTs) for anti-pneumococcal antibody (MOPA-6B), one month after the administration of Prevnar 13 vaccine dose.||1.73|1.07|
72386545|NCT03439657|144281182|NON_INFERIORITY|Upper limit (UL) of 95% CI for each individual pneumococcal conjugate serotype Geometric Mean Titer (GMT) ratio of the Control group over the Co-Ad group should be \<2.|GMT ratio|1.21|||||TWO_SIDED|95.0|1.01|1.44|||ANCOVA|The 95% CI of the group MOPA GMT ratios was computed using an Analysis Of Covariance (ANCOVA) model on the log10 transformation of the concentrations.||Anti-pneumococcal antibody titers (non-inferiority): Non-inferiority comparison between Control Group and Co-Ad Group in terms of geometric mean titers (GMTs) for anti-pneumococcal antibody (MOPA-7F), one month after the administration of Prevnar 13 vaccine dose.||1.44|1.01|
72386546|NCT03439657|144281182|NON_INFERIORITY|Upper limit (UL) of 95% CI for each individual pneumococcal conjugate serotype Geometric Mean Titer (GMT) ratio of the Control group over the Co-Ad group should be \<2.|GMT ratio|1.16|||||TWO_SIDED|95.0|0.97|1.39|||ANCOVA|The 95% CI of the group MOPA GMT ratios was computed using an Analysis Of Covariance (ANCOVA) model on the log10 transformation of the concentrations.||Anti-pneumococcal antibody titers (non-inferiority): Non-inferiority comparison between Control Group and Co-Ad Group in terms of geometric mean titers (GMTs) for anti-pneumococcal antibody (MOPA-9V), one month after the administration of Prevnar 13 vaccine dose.||1.39|0.97|
72386547|NCT03439657|144281182|NON_INFERIORITY|Upper limit (UL) of 95% CI for each individual pneumococcal conjugate serotype Geometric Mean Titer (GMT) ratio of the Control group over the Co-Ad group should be \<2.|GMT ratio|1.15|||||TWO_SIDED|95.0|0.94|1.42|||ANCOVA|The 95% CI of the group MOPA GMT ratios was computed using an Analysis Of Covariance (ANCOVA) model on the log10 transformation of the concentrations.||Anti-pneumococcal antibody titers (non-inferiority): Non-inferiority comparison between Control Group and Co-Ad Group in terms of geometric mean titers (GMTs) for anti-pneumococcal antibody (MOPA-14), one month after the administration of Prevnar 13 vaccine dose.||1.42|0.94|
72386548|NCT03439657|144281182|NON_INFERIORITY|Upper limit (UL) of 95% CI for each individual pneumococcal conjugate serotype Geometric Mean Titer (GMT) ratio of the Control group over the Co-Ad group should be \<2.|GMT ratio|1.11|||||TWO_SIDED|95.0|0.92|1.34|||ANCOVA|The 95% CI of the group MOPA GMT ratios was computed using an Analysis Of Covariance (ANCOVA) model on the log10 transformation of the concentrations.||Anti-pneumococcal antibody titers (non-inferiority): Non-inferiority comparison between Control Group and Co-Ad Group in terms of geometric mean titers (GMTs) for anti-pneumococcal antibody (MOPA-18C), one month after the administration of Prevnar 13 vaccine dose.||1.34|0.92|
72386549|NCT03439657|144281182|NON_INFERIORITY|Upper limit (UL) of 95% CI for each individual pneumococcal conjugate serotype Geometric Mean Titer (GMT) ratio of the Control group over the Co-Ad group should be \<2.|GMT ratio|1.03|||||TWO_SIDED|95.0|0.87|1.22|||ANCOVA|The 95% CI of the group MOPA GMT ratios was computed using an Analysis Of Covariance (ANCOVA) model on the log10 transformation of the concentrations.||Anti-pneumococcal antibody titers (non-inferiority): Non-inferiority comparison between Control Group and Co-Ad Group in terms of geometric mean titers (GMTs) for anti-pneumococcal antibody (MOPA-19A), one month after the administration of Prevnar 13 vaccine dose.||1.22|0.87|
72386550|NCT03439657|144281182|NON_INFERIORITY|Upper limit (UL) of 95% CI for each individual pneumococcal conjugate serotype Geometric Mean Titer (GMT) ratio of the Control group over the Co-Ad group should be \<2.|GMT ratio|1.09|||||TWO_SIDED|95.0|0.9|1.32|||ANCOVA|The 95% CI of the group MOPA GMT ratios was computed using an Analysis Of Covariance (ANCOVA) model on the log10 transformation of the concentrations.||Anti-pneumococcal antibody titers (non-inferiority): Non-inferiority comparison between Control Group and Co-Ad Group in terms of geometric mean titers (GMTs) for anti-pneumococcal antibody (MOPA-19F), one month after the administration of Prevnar 13 vaccine dose.||1.32|0.90|
72386551|NCT03439657|144281182|NON_INFERIORITY|Upper limit (UL) of 95% CI for each individual pneumococcal conjugate serotype Geometric Mean Titer (GMT) ratio of the Control group over the Co-Ad group should be \<2.|GMT ratio|1.2|||||TWO_SIDED|95.0|0.96|1.5|||ANCOVA|The 95% CI of the group MOPA GMT ratios was computed using an Analysis Of Covariance (ANCOVA) model on the log10 transformation of the concentrations.||Anti-pneumococcal antibody titers (non-inferiority): Non-inferiority comparison between Control Group and Co-Ad Group in terms of geometric mean titers (GMTs) for anti-pneumococcal antibody (MOPA-23F), one month after the administration of Prevnar 13 vaccine dose.||1.50|0.96|
72386552|NCT00370071|144281198|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||one-sided p-value (one-sided test level 2.5%)|Wilcoxon-Signed-Rank test|||In this single arm study, the number of newly active lesions per 3 months during treatment was compared to the number of newly active lesions during 3-month pre-treatment (Alternative hypothesis: Number of lesions is reduced during treatment with Interferon beta-1b). The sample size was calculated for the use of the one-sided Wilcoxon-Signed-Rank test at level 2.5% (Power of 90% - anticipating P(X\&lt;Y)=0.15 and allowing for 25% exclusion from Per Protocol Set).||||<0.0001
72439064|NCT01149369|144391973|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.5||||0.05|TWO_SIDED|95.0|-1.0|0.0|||ANCOVA|||||0.0|-1.0|0.05
72439065|NCT01149369|144391974|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.4||||0.08|TWO_SIDED|95.0|-0.9|0.1|||ANCOVA|||||0.1|-0.9|0.08
72439066|NCT01149369|144391975|SUPERIORITY|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.3||||0.53|TWO_SIDED|95.0|-1.1|0.6|||ANCOVA|||||0.6|-1.1|0.53
72495422|NCT01340209|144519885|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.498|STANDARD_ERROR_OF_MEAN|12.282||0.9677|TWO_SIDED|95.0|-23.634|24.63|||Mixed Models Analysis|adjusted for treatment, week, baseline, treatment\*week and baseline\*week||Difference calculated as Tiotropium 2.5 µg minus placebo||24.630|-23.634|0.9677
72495423|NCT01340209|144519885|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|34.176|STANDARD_ERROR_OF_MEAN|12.346||0.0058|TWO_SIDED|95.0|9.919|58.432|||Mixed Models Analysis|adjusted for treatment, week, baseline, treatment\*week and baseline\*week||Difference calculated as Tiotropium Respimat 5 μg minus placebo||58.432|9.919|0.0058
72386553|NCT00370071|144281199|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||one-sided p-value (one-sided test level 2.5%)|Wilcoxon-Signed-Rank test|||||||<0.0001
72386554|NCT00370071|144281200|SUPERIORITY_OR_OTHER|||||||0.0017||95.0||||one-sided p-value (one-sided test level 2.5%)|Wilcoxon-Signed-Rank test|||||||0.0017
72386555|NCT00370071|144281201|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon-Signed-Rank test|One-sided p-value from Wilcoxon-Signed-Rank-Test for comparing the baseline visit to treatment visits||Lesion volume at Week 12. 38 subjects were evaluated.||||<0.0001
72386556|NCT00370071|144281201|SUPERIORITY_OR_OTHER||||||=|0.0019|||||||Wilcoxon-Signed-Rank test|||Lesion volume at Week 24. 37 subjects were evaluated.||||=0.0019
72386557|NCT01999868|144281222|SUPERIORITY|||||||0.41||||||Two-sided test.|Regression, Logistic|Randomization stratum (PASI score at week 0: 12-20 or \>20) and duration of disease prior to screening, centered about the median, are covariates.||Week 12 to 88. This interval corresponds to the time from randomization until the end of the study. This analysis is the primary analysis of the primary endpoint.||||0.41
72386558|NCT01999868|144281222|SUPERIORITY|||||||0.013||||||Two-sided test.|Regression, Logistic|Randomization stratum (PASI score at week 0: 12-20 or \>20) and duration of disease prior to screening, centered about the median, are covariates.||Week 12 to 40. This interval corresponds to the time from randomization until the end of the blinded treatment phase.||||0.013
72386559|NCT01999868|144281222|SUPERIORITY|||||||0.5||||||Two-sided test.|Regression, Logistic|Randomization stratum (PASI score at week 0: 12-20 or \>20) and duration of disease prior to screening, centered about the median, are covariates.||Week 28 to 88. This interval corresponds to the time from the last scheduled dose of ustekinumab or ustekinumab placebo until the end of the study.||||0.50
72386560|NCT01999868|144281222|SUPERIORITY|||||||0.67||||||Two-sided test.|Regression, Logistic|Randomization stratum (PASI score at week 0: 12-20 or \>20) and duration of disease prior to screening, centered about the median, are covariates.||Week 40 to 88. This interval corresponds to the time from the beginning of the blinded observation phase until the end of the study.||||0.67
72386561|NCT01999868|144281223|SUPERIORITY|||||||0.019||||||Two-sided test.|Regression, Logistic|Randomization stratum (PASI score at week 0: 12-20 or \>20) and duration of disease prior to screening, centered about the median, are covariates.||Week 12 to 88. This interval corresponds to the time from randomization until the end of the study.||||0.019
72386562|NCT01999868|144281223|SUPERIORITY|||||||0.001||||||Two-sided test.|Regression, Logistic|Randomization stratum (PASI score at week 0: 12-20 or \>20) and duration of disease prior to screening, centered about the median, are covariates.||Week 12 to 40. This interval corresponds to the time from randomization until the end of the blinded treatment phase.||||0.001
72386563|NCT01999868|144281223|SUPERIORITY|||||||0.018||||||Two-sided test.|Regression, Logistic|Randomization stratum (PASI score at week 0: 12-20 or \>20) and duration of disease prior to screening, centered about the median, are covariates.||Week 28 to 88. This interval corresponds to the time from the last scheduled dose of ustekinumab or ustekinumab placebo until the end of the study.||||0.018
72386564|NCT01999868|144281223|SUPERIORITY|||||||0.07||||||Two-sided test.|Regression, Logistic|Randomization stratum (PASI score at week 0: 12-20 or \>20) and duration of disease prior to screening, centered about the median, are covariates.||Week 40 to 88. This interval corresponds to the time from the beginning of the blinded observation phase until the end of the study.||||0.07
72439067|NCT01149369|144391976|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.4||||0.38|TWO_SIDED|95.0|-1.3|0.5|||ANCOVA|||||0.5|-1.3|0.38
72495424|NCT01340209|144519886|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.646|STANDARD_ERROR_OF_MEAN|9.182||0.3468|TWO_SIDED|95.0|-9.388|26.68|||Mixed Models Analysis|adjusted for treatment, week, baseline, treatment\*week and baseline\*week||Difference calculated as Tiotropium 2.5 µg minus placebo||26.680|-9.388|0.3468
72495425|NCT01340209|144519886|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.216|STANDARD_ERROR_OF_MEAN|9.238||0.5013||95.0|-11.927|24.359|||Mixed Models Analysis|adjusted for treatment, week, baseline, treatment\*week and baseline\*week||Difference calculated as Tiotropium 5 μg minus placebo||24.359|-11.927|0.5013
72495426|NCT01340209|144519887|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.458|STANDARD_ERROR_OF_MEAN|9.196||0.2132|TWO_SIDED|95.0|-6.601|29.517|||Mixed Models Analysis|adjusted for treatment, week, baseline, treatment\*week and baseline\*week||Difference calculated as Tiotropium 2.5 µg minus placebo||29.517|-6.601|0.2132
72495427|NCT01340209|144519887|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.398|STANDARD_ERROR_OF_MEAN|9.245||0.0766|TWO_SIDED|95.0|-1.759|34.555|||Mixed Models Analysis|adjusted for treatment, week, baseline, treatment\*week and baseline\*week||Difference calculated as Tiotropium 5 μg minus placebo||34.555|-1.759|0.0766
72439068|NCT01149369|144391977|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-2.2||||0.09|TWO_SIDED|95.0|-4.7|0.4|||ANCOVA|||||0.4|-4.7|0.09
72439069|NCT01149369|144391978|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-1.8||||0.28|TWO_SIDED|95.0|-5.2|1.5|||ANCOVA|||||1.5|-5.2|0.28
72439070|NCT01149369|144391979|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-1.6||||0.3|TWO_SIDED|95.0|-4.6|1.4|||ANCOVA|||||1.4|-4.6|0.30
72439071|NCT01149369|144391980|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-21.2||||0.4|TWO_SIDED|95.0|-70.5|28.1|||ANCOVA|||||28.1|-70.5|0.40
72439072|NCT01149369|144391981|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-4.2||||0.28|TWO_SIDED|95.0|-12.0|3.5|||ANCOVA|||||3.5|-12.0|0.28
72439073|NCT01149369|144391982|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|2.4||||0.47|TWO_SIDED|95.0|-4.1|8.9|||ANCOVA|||||8.9|-4.1|0.47
72439074|NCT01149369|144391983|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|1.2||||0.68|TWO_SIDED|95.0|-4.5|6.9|||ANCOVA|||||6.9|-4.5|0.68
72439075|NCT01149369|144391984|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|2.0||||0.48|TWO_SIDED|95.0|-3.6|7.6|||ANCOVA|||||7.6|-3.6|0.48
72439076|NCT01149369|144391985|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|1.5||||0.43|TWO_SIDED|95.0|-2.2|5.1|||ANCOVA|||||5.1|-2.2|0.43
72439077|NCT01149369|144391986|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-4.8||||0.01|TWO_SIDED|95.0|-8.5|-1.2|||ANCOVA|||||-1.2|-8.5|0.01
72439078|NCT01149369|144391987|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|1.4||||0.57|TWO_SIDED|95.0|-3.4|6.1|||ANCOVA|||||6.1|-3.4|0.57
72439079|NCT01149369|144391988|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.84||||0.34|TWO_SIDED|95.0|-2.6|1.0|||ANCOVA|||||1.0|-2.6|0.34
72439080|NCT01599793|144392028|EQUIVALENCE|Testing if the change of ktrans between 2 weeks and baseline = 0 (i.e testing if the difference of means between 2 weeks and baseline =0)||||||0.0016|||||||Mixed Models Analysis|||The least square means of ktrans at different time points (baseline, 2 weeks, 12 weeks, 24 weeks) are estimated by a linear mixed model. Comparison of means at different time points were performed. The primary result reported below is for the difference of means between 2 weeks and baseline.||||0.0016
72439081|NCT01599793|144392030|OTHER|We calculated Spearman Correlation Coefficient between the percent change in Ktrans (from week 0 to 12) and the bone scan response change. We tested if the coefficient = 0|Spearman Correlation Coefficients|0.36853||||0.3291|TWO_SIDED||||||t-test, 2 sided|||||||0.3291
72439082|NCT01599793|144392032|OTHER|We calculated Spearman Correlation Coefficient between the percent change in Ktrans (from week 0 to 12) and the PSA change. We tested if the coefficient = 0|Spearman Correlation Coefficients|-0.41818||||0.2006|TWO_SIDED||||||t-test, 2 sided|||||||0.2006
72439083|NCT01599793|144392034|OTHER|We calculated Spearman Correlation Coefficient between the percent change in Ktrans (from week 0 to 12) and the Change in pain scale. We tested if the coefficient = 0|Spearman Correlation Coefficients|0.17669||||0.5828|TWO_SIDED||||||t-test, 2 sided|||||||0.5828
72439084|NCT01943799|144392076|SUPERIORITY||LS Mean Difference|-0.001||||0.976|TWO_SIDED|95.0|-0.061|0.059|||MMRM|||Each null hypothesis was tested against the 2-sided alternative that the mean change from baseline in serum HBsAg (log10 IU/mL) titers in the respective GS-4774 group was not equal to that of the OAV group. Estimated least squares means (LSM) of treatment effects and estimated differences in treatment effects between GS-4774 treatment groups and the OAV group at Week 24 were calculated with 95% confidence intervals (CIs) and unadjusted p-values.||0.059|-0.061|0.976
72439085|NCT01943799|144392076|SUPERIORITY||LS Mean Difference|-0.007||||0.828|TWO_SIDED|95.0|-0.067|0.053|||MMRM|||Each null hypothesis was tested against the 2-sided alternative that the mean change from baseline in serum HBsAg (log10 IU/mL) titers in the respective GS-4774 group was not equal to that of the OAV group. Estimated least squares means (LSM) of treatment effects and estimated differences in treatment effects between GS-4774 treatment groups and the OAV group at Week 24 were calculated with 95% confidence intervals (CIs) and unadjusted p-values.||0.053|-0.067|0.828
72439086|NCT01943799|144392076|SUPERIORITY||LS Mean Difference|-0.029||||0.343|TWO_SIDED|95.0|-0.089|0.031|||MMRM|||Each null hypothesis was tested against the 2-sided alternative that the mean change from baseline in serum HBsAg (log10 IU/mL) titers in the respective GS-4774 group was not equal to that of the OAV group. Estimated least squares means (LSM) of treatment effects and estimated differences in treatment effects between GS-4774 treatment groups and the OAV group at Week 24 were calculated with 95% confidence intervals (CIs) and unadjusted p-values.||0.031|-0.089|0.343
72439087|NCT03811574|144392092|SUPERIORITY||Treatment difference|-7.52|||<|0.0001|TWO_SIDED|95.0|-9.62|-5.43|||ANCOVA|||Treatment policy estimand||-5.43|-9.62|<.0001
72439088|NCT03811574|144392092|SUPERIORITY||Treatment difference|-11.06|||<|0.0001|TWO_SIDED|95.0|-12.88|-9.24|||ANCOVA|||Treatment policy estimand||-9.24|-12.88|<.0001
72439089|NCT03811574|144392093|SUPERIORITY||Odds Ratio (OR)|11.08|||<|0.0001|TWO_SIDED|95.0|5.53|22.22|||Regression, Logistic|||Treatment policy estimand||22.22|5.53|<.0001
72439090|NCT03811574|144392093|SUPERIORITY||Odds Ratio (OR)|21.72|||<|0.0001|TWO_SIDED|95.0|11.27|41.86|||Regression, Logistic|||Treatment policy estimand||41.86|11.27|<.0001
72439091|NCT00958633|144392133|SUPERIORITY||Hazard Ratio (HR)|0.68||||0.12|TWO_SIDED|95.0|0.43|1.1|||Log Rank||The hazard ratio for time to any mood episode in the 52-week group relative to the 8-week group was 0.68 (95% confidence interval \[CI\], 0.43 to 1.10; P = 0.12 by log-rank test).|||1.10|0.43|0.12
72439092|NCT00958633|144392134|SUPERIORITY||Hazard Ratio (HR)|2.28|||||TWO_SIDED|95.0|0.86|6.08||||||Manic or Hypomanic events||6.08|.86|
72439093|NCT00958633|144392134|SUPERIORITY||Hazard Ratio (HR)|0.43|||||TWO_SIDED|95.0|0.25|0.75||||||Depressive Events||0.75|0.25|
72439094|NCT01499654|144392173|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.001
72439095|NCT01499654|144392173|SUPERIORITY_OR_OTHER|||||||0.67|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.67
72439096|NCT01499654|144392174|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<0.001
72439097|NCT01499654|144392174|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.002
72439098|NCT01499654|144392175|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<0.001
72439099|NCT01499654|144392175|SUPERIORITY_OR_OTHER|||||||0.08|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.08
72439100|NCT01499654|144392176|SUPERIORITY_OR_OTHER|||||||0.006|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.006
72439101|NCT01499654|144392176|SUPERIORITY_OR_OTHER|||||||0.44|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.44
72439102|NCT01395758|144392179|SUPERIORITY|||||||0.5017|||||||Log Rank|||||||0.5017
72439103|NCT01395758|144392180|SUPERIORITY|||||||0.4356|||||||Log Rank|||||||0.4356
72439104|NCT00357097|144392189|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.6|||<|0.001||95.0|-5.6|-1.6|||ANCOVA||Mean difference = Ropinirole minus Placebo. Used adjusted change from baseline.|||-1.6|-5.6|<0.001
72439105|NCT00262730|144392282|NON_INFERIORITY_OR_EQUIVALENCE|study design has 85% power to detect 25% deduction in hazard rate compared to EORTC Phase 3 results.|Hazard Ratio (HR)|0.8|STANDARD_DEVIATION|0.025|>|0.1|TWO_SIDED|95.0|0.8|0.85|||Log Rank|||||0.85|0.8|>.1
72439106|NCT03887650|144392283|SUPERIORITY|||||||0.127|||||||Wilcoxon (Mann-Whitney)|||||||0.127
72439107|NCT03887650|144392284|SUPERIORITY|||||||0.975|||||||Wilcoxon (Mann-Whitney)|||||||.975
72439108|NCT03887650|144392285|SUPERIORITY|||||||0.852||||||PACU pain scores|Wilcoxon (Mann-Whitney)|||||||.852
72439109|NCT03887650|144392285|SUPERIORITY|||||||0.661||||||For (PACU-24) minimum pain scores|Wilcoxon (Mann-Whitney)|||||||.661
72439110|NCT03887650|144392285|SUPERIORITY|||||||0.747||||||For (PACU-24 hr.) maximum pain score|Wilcoxon (Mann-Whitney)|||||||.747
72439111|NCT03887650|144392285|SUPERIORITY|||||||0.604||||||For (PACU-24 hr) average pain scores|Wilcoxon (Mann-Whitney)|||||||.604
72439112|NCT03887650|144392285|SUPERIORITY|||||||0.002||||||(24-48 hr) minimum pain scores|Wilcoxon (Mann-Whitney)|||||||.002
72439113|NCT03887650|144392285|SUPERIORITY||||||<|0.01||||||For (24-48 hr) maximum pain scores|Wilcoxon (Mann-Whitney)|||||||<0.01
72439114|NCT03887650|144392285|SUPERIORITY||||||<|0.01||||||For (24-48 hr) average pain scores|Wilcoxon (Mann-Whitney)|||||||<0.01
72439115|NCT03887650|144392285|SUPERIORITY|||||||0.011||||||(48-72 hr) minimum pain scores|Wilcoxon (Mann-Whitney)|||||||.011
72439116|NCT03887650|144392285|SUPERIORITY|||||||0.001||||||(48-72 hr) maximum pain scores|Wilcoxon (Mann-Whitney)|||||||.001
72439117|NCT03887650|144392285|SUPERIORITY|||||||0.003||||||(48-72 hr) average pain scores|Wilcoxon (Mann-Whitney)|||||||.003
72439118|NCT03887650|144392285|SUPERIORITY|||||||0.23||||||For (72-96 hr) minimum pain scores|Wilcoxon (Mann-Whitney)|||||||.230
72439119|NCT03887650|144392285|SUPERIORITY|||||||0.007||||||For (72-96 hr) maximum pain scores|Wilcoxon (Mann-Whitney)|||||||.007
72439120|NCT03887650|144392285|SUPERIORITY|||||||0.011||||||For (72-96 hr) average pain scores|Wilcoxon (Mann-Whitney)|||||||.011
72439121|NCT03887650|144392285|SUPERIORITY|||||||0.378||||||For (postoperative day 60) minimum pain scores|Wilcoxon (Mann-Whitney)|||||||.378
72439122|NCT03887650|144392285|SUPERIORITY|||||||0.001||||||For (postoperative day 60) maximum pain scores|Wilcoxon (Mann-Whitney)|||||||.001
72439123|NCT03887650|144392285|SUPERIORITY|||||||0.403||||||For (postoperative day 60) average pain scores|Wilcoxon (Mann-Whitney)|||||||.403
72439124|NCT03887650|144392286|SUPERIORITY|||||||0.112|||||||Wilcoxon (Mann-Whitney)|||||||.112
72439125|NCT03887650|144392287|SUPERIORITY|||||||0.096||||||P-Value for POD4|Fisher Exact|Fisher's Exact for POD4||||||0.096
72439126|NCT03887650|144392287|SUPERIORITY|||||||1||||||For POD60|Chi-squared|Chi-squared for POD60||||||1.0
72439127|NCT03887650|144392288|SUPERIORITY|||||||1||||||Any distress on PACU|Chi-squared|||||||1.0
72439128|NCT03887650|144392288|SUPERIORITY|||||||0.947||||||Postoperative day 2|Chi-squared|||||||.947
72439129|NCT03887650|144392289|SUPERIORITY|||||||0.441||||||Full sensation|Fishers Freeman Halton|||||||.441
72439130|NCT03887650|144392289|SUPERIORITY|||||||0.691||||||First sensation|Fishers Freeman Halton|||||||.691
72439131|NCT03887650|144392290|SUPERIORITY|||||||0.876|||||||Wilcoxon (Mann-Whitney)|||||||.876
72439132|NCT03887650|144392291|SUPERIORITY|||||||0.011||||||Any movement|Fisher' Freeman Halton|||||||.011
72439133|NCT03887650|144392291|SUPERIORITY|||||||0.536||||||Full movement|Fishers Freeman Halton|||||||.536
72439134|NCT03887650|144392292|SUPERIORITY|||||||0.648||||||MME 0-24|Wilcoxon (Mann-Whitney)|||||||.648
72439135|NCT03887650|144392292|SUPERIORITY|||||||0.285||||||MME24-48|Wilcoxon (Mann-Whitney)|||||||.285
72439136|NCT03887650|144392292|SUPERIORITY|||||||0.122||||||MME48-72|Wilcoxon (Mann-Whitney)|||||||.122
72439137|NCT03887650|144392292|SUPERIORITY|||||||0.367||||||MME 72-120|Wilcoxon (Mann-Whitney)|||||||.367
72439138|NCT01503749|144392303|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||t-test, 2 sided|||||||>0.05
72439139|NCT05714696|144392304|SUPERIORITY|||||||0.007|||||||t-test, 2 sided|||||||.007
72439140|NCT05714696|144392305|SUPERIORITY|||||||0.049|||||||t-test, 2 sided|||||||.049
72439141|NCT05714696|144392306|SUPERIORITY|||||||0.029|||||||t-test, 2 sided|||||||.029
72439142|NCT05714696|144392307|SUPERIORITY|||||||0.163|||||||t-test, 2 sided|||||||.163
72439143|NCT05714696|144392308|SUPERIORITY|||||||0.442|||||||t-test, 2 sided|||||||.442
72439144|NCT05714696|144392310|SUPERIORITY|||||||0.527|||||||t-test, 2 sided|||||||.527
72439145|NCT05714696|144392311|SUPERIORITY|||||||0.311|||||||t-test, 2 sided|||||||.311
72439146|NCT05714696|144392312|SUPERIORITY|||||||0.004|||||||t-test, 2 sided|||||||.004
72439147|NCT05714696|144392313|SUPERIORITY|||||||0.005|||||||Chi-squared|||||||.005
72439148|NCT00696618|144392315|SUPERIORITY_OR_OTHER||||||<|0.05||||||Adjusted for multiple comparisons.|multi-level|||Nine research participants provided the ability to detect an effect size of 1.25 standard deviation units relative to the mean with 80% power using two-sided, 5% alpha in a paired analysis. The Baseline condition (no intervention) was assigned a value of 1 and geometric mean ratios with 95% confidence intervals for each intervention were calculated relative to baseline.||||<.05
72439149|NCT00696618|144392316|SUPERIORITY_OR_OTHER||||||<|0.05|||||||multi-level|||||||<.05
72439150|NCT00696618|144392317|SUPERIORITY_OR_OTHER||||||<|0.05|||||||mulit-level analysis|||||||<.05
72439151|NCT00940537|144392324|SUPERIORITY_OR_OTHER|||||||0.097||95.0||||a priori threshhold for significance was set at p\<0.05.|t-test, 2 sided|this was a paired t-test||As there was no a priori reason for the level of IHTG to impact this measurement we compared the pre and post-prandial results for all subjects whose data were of sufficient quality (N=12). These results are comparing the two categories of fasting and post-prandial. Null hypothesis was that there would be no difference in IHTG before and after a high fat, high carbohydrate meal.||||.097
72439152|NCT00940537|144392325|SUPERIORITY_OR_OTHER|||||||0.006||95.0||||This p-value compares the low IHTG (\<5%) subjects to those with medium levels of IHTG (5 - 10%). The a priori threshold for statistical significance was p\<0.05.|t-test, 2 sided|||null hypothesis was that the T2 ratio would not depend on level of intrahepatic triglyceride (IHTG) and would be equal for the low and medium IHTG categories.||||0.006
72439153|NCT00940537|144392325|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||The a priori threshold for statistical significance was p\<0.05.|t-test, 2 sided|||null hypothesis was that the T2 ratio would not depend on level of intra-hepatic triglyceride (IHTG) and would be equal for the low (\<5%) and high (\>10%) IHTG categories.||||<0.0001
72439154|NCT00940537|144392325|SUPERIORITY_OR_OTHER|||||||0.93||95.0||||The a priori threshold for statistical significance was set at p\<0.05.|t-test, 2 sided|||The null hypothesis was that there would be no difference in T2 relaxation ratios for varying levels of intra-hepatic triglyceride (IHTG). Thus the medium (5 - 10%) and high (\<10%) IHTG groups would not be statistically different with regard to average T2 ratio.||||.93
72439155|NCT01199705|144392332|SUPERIORITY_OR_OTHER||Annualized Rate|0.0|||||ONE_SIDED|99.0||1.39||||||||1.390||
72439156|NCT01199705|144392332|SUPERIORITY_OR_OTHER||Annualized Rate|0.0|||||ONE_SIDED|99.0||0.953||||||||0.953||
72439157|NCT01199705|144392332|SUPERIORITY_OR_OTHER||Annualized Rate|0.0|||||ONE_SIDED|99.0||0.914||||||||0.914||
72439158|NCT01199705|144392334|SUPERIORITY_OR_OTHER||Annualized Rate|0.0|||||ONE_SIDED|99.0||1.204||||||||1.204||
72439159|NCT01199705|144392334|SUPERIORITY_OR_OTHER||Annualized Rate|0.0|||||ONE_SIDED|99.0||0.834||||||||0.834||
72439160|NCT01199705|144392334|SUPERIORITY_OR_OTHER||Annualized Rate|0.0|||||ONE_SIDED|99.0||0.802||||||||0.802||
72439161|NCT01415349|144392339|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Point estimates and 90% confidence intervals were assessed against the currently accepted bioequivalence criteria for log-transformed data (0.80, 1.25).|Ratio of Geometric LS Means|1.03|||||TWO_SIDED|90.0|0.966|1.09|||Mixed Models Analysis|||||1.09|0.966|
72439162|NCT01415349|144392340|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Point estimates and 90% confidence intervals were assessed against the currently accepted bioequivalence criteria for log-transformed data (0.80, 1.25).|Ratio of Geometric LS Means|1.04|||||TWO_SIDED|90.0|0.998|1.08|||Mixed Models Analysis|||||1.08|0.998|
72439163|NCT01616459|144392348|NON_INFERIORITY_OR_EQUIVALENCE|GMCs ratio and its CI were calculated using an ANCOVA model on the logarithm-transformed concentrations, including the vaccine group as fixed effect and the pre-vaccination concentration as regressor. The GMCs were used to calculate the Adjusted GMCs (N=218 and Adjusted GMC =1.51 in the 11Pn Group and N= 203 and Adjusted GMC= 1.36 for the Synflorix Group) which in turn were used to calculate the Adjusted GMC ratio with 95.9% confidence interval.|Adjusted GMCs ratio|0.9|||||TWO_SIDED|95.9|0.75|1.07||||||ANTI-1 serotype test :to demonstrate that 11Pn co-administered with Infanrix hexa™ 1 month post-dose 3 was non-inferior for at least 9 out of 11 vaccine serotypes to Prevnar13 (for 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of Enzyme-linked immunosorbent assay (ELISA) GMCs. Criteria: UL of the 2-sided 95.9% CI of the ELISA GMC ratios (Prevnar13/11Pn) and (Synflorix/11Pn) groups \< a limit of 2-fold for at least 9 out of 11 vaccine pneumococcal serotypes.||1.07|0.75|
72439164|NCT01616459|144392348|NON_INFERIORITY_OR_EQUIVALENCE|GMCs ratio and its CI were calculated using an ANCOVA model on the logarithm-transformed concentrations, including the vaccine group as fixed effect and the pre-vaccination concentration as regressor. The GMCs were used to calculate the Adjusted GMCs (N=218 and Adjusted GMC =1.77 in the 11Pn Group and N= 203 and Adjusted GMC= 1.66 for the Synflorix Group) which in turn were used to calculate the Adjusted GMC ratio with 95.9% confidence interval.|Adjusted GMCs ratio|0.94|||||TWO_SIDED|95.9|0.77|1.14||||||ANTI-4 serotype test: To demonstrate that 11Pn co-administered with Infanrix hexa™ 1 month post-dose 3 was non-inferior for at least 9 out of 11 vaccine serotypes to Prevnar13 (for 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of Enzyme-linked immunosorbent assay (ELISA) GMCs. Criteria: UL of the 2-sided 95.9% CI of the ELISA GMC ratios (Prevnar13/11Pn) and (Synflorix/11Pn) groups \< a limit of 2-fold for at least 9 out of 11 vaccine pneumococcal serotypes.||1.14|0.77|
72495428|NCT01340209|144519888|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.601|STANDARD_ERROR_OF_MEAN|1.038||0.5629|TWO_SIDED|95.0|-2.637|1.436|||Mixed Models Analysis|adjusted for treatment, week, baseline, treatment\*week and baseline\*week||Difference calculated as Tiotropium 2.5 µg minus placebo||1.436|-2.637|0.5629
72439165|NCT01616459|144392348|NON_INFERIORITY_OR_EQUIVALENCE|GMCs ratio and its CI were calculated using an ANCOVA model on the logarithm-transformed concentrations, including the vaccine group as fixed effect and the pre-vaccination concentration as regressor. The GMCs were used to calculate the Adjusted GMCs (N=218 and Adjusted GMC = 2.46 in the 11Pn Group and N= 201 and Adjusted GMC= 2.16 for the Synflorix Group) which in turn were used to calculate the Adjusted GMC ratio with 95.9% confidence interval.|Adjusted GMCs ratio|0.88|||||TWO_SIDED|95.9|0.75|1.03||||||ANTI-5 serotype test: To demonstrate that 11Pn co-administered with Infanrix hexa™ 1 month post-dose 3 was non-inferior for at least 9 out of 11 vaccine serotypes to Prevnar13 (for 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of Enzyme-linked immunosorbent assay (ELISA) GMCs. Criteria: UL of the 2-sided 95.9% CI of the ELISA GMC ratios (Prevnar13/11Pn) and (Synflorix/11Pn) groups \< a limit of 2-fold for at least 9 out of 11 vaccine pneumococcal serotypes.||1.03|0.75|
72439166|NCT01616459|144392348|NON_INFERIORITY_OR_EQUIVALENCE|GMCs ratio and its CI were calculated using an ANCOVA model on the logarithm-transformed concentrations, including the vaccine group as fixed effect and the pre-vaccination concentration as regressor. The GMCs were used to calculate the Adjusted GMCs (N=218 and Adjusted GMC =0.51 in the 11Pn Group and N= 200 and Adjusted GMC= 0.47 for the Synflorix Group) which in turn were used to calculate the Adjusted GMC ratio with 95.9% confidence interval.|Adjusted GMCs ratio|0.93|||||TWO_SIDED|95.9|0.71|1.23||||||ANTI-6B serotype test: To demonstrate that 11Pn co-administered with Infanrix hexa™ 1 month post-dose 3 was non-inferior for at least 9 out of 11 vaccine serotypes to Prevnar13 (for 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of Enzyme-linked immunosorbent assay (ELISA) GMCs. Criteria: UL of the 2-sided 95.9% CI of the ELISA GMC ratios (Prevnar13/11Pn) and (Synflorix/11Pn) groups \< a limit of 2-fold for at least 9 out of 11 vaccine pneumococcal serotypes.||1.23|0.71|
72439167|NCT01616459|144392348|NON_INFERIORITY_OR_EQUIVALENCE|GMCs ratio and its CI were calculated using an ANCOVA model on the logarithm-transformed concentrations, including the vaccine group as fixed effect and the pre-vaccination concentration as regressor. The GMCs were used to calculate the Adjusted GMCs (N=219 and Adjusted GMC =2.30 in the 11Pn Group and N= 202 and Adjusted GMC= 2.17 for the Synflorix Group) which in turn were used to calculate the Adjusted GMC ratio with 95.9% confidence interval.|Adjusted GMCs ratio|0.94|||||TWO_SIDED|95.9|0.81|1.1||||||ANTI-7F serotype test: To demonstrate that 11Pn co-administered with Infanrix hexa™ 1 month post-dose 3 was non-inferior for at least 9 out of 11 vaccine serotypes to Prevnar13 (for 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of Enzyme-linked immunosorbent assay (ELISA) GMCs. Criteria: UL of the 2-sided 95.9% CI of the ELISA GMC ratios (Prevnar13/11Pn) and (Synflorix/11Pn) groups \< a limit of 2-fold for at least 9 out of 11 vaccine pneumococcal serotypes.||1.10|0.81|
72439168|NCT01616459|144392348|NON_INFERIORITY_OR_EQUIVALENCE|GMCs ratio and its CI were calculated using an ANCOVA model on the logarithm-transformed concentrations, including the vaccine group as fixed effect and the pre-vaccination concentration as regressor. The GMCs were used to calculate the Adjusted GMCs (N=218 and Adjusted GMC =1.56 in the 11Pn Group and N= 200 and Adjusted GMC= 1.40 for the Synflorix Group) which in turn were used to calculate the Adjusted GMC ratio with 95.9% confidence interval.|Adjusted GMCs ratio|0.89|||||TWO_SIDED|95.9|0.76|1.06||||||ANTI-9V serotype test: To demonstrate that 11Pn co-administered with Infanrix hexa™ 1 month post-dose 3 was non-inferior for at least 9 out of 11 vaccine serotypes to Prevnar13 (for 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of Enzyme-linked immunosorbent assay (ELISA) GMCs. Criteria: UL of the 2-sided 95.9% CI of the ELISA GMC ratios (Prevnar13/11Pn) and (Synflorix/11Pn) groups \< a limit of 2-fold for at least 9 out of 11 vaccine pneumococcal serotypes.||1.06|0.76|
72439169|NCT01616459|144392348|NON_INFERIORITY_OR_EQUIVALENCE|GMCs ratio and its CI were calculated using an ANCOVA model on the logarithm-transformed concentrations, including the vaccine group as fixed effect and the pre-vaccination concentration as regressor. The GMCs were used to calculate the Adjusted GMCs (N=218 and Adjusted GMC = 4.22 in the 11Pn Group and N= 201 and Adjusted GMC= 4.06 for the Synflorix Group) which in turn were used to calculate the Adjusted GMC ratio with 95.9% confidence interval.|Adjusted GMCs ratio|0.96|||||TWO_SIDED|95.9|0.81|1.15||||||ANTI-14 serotype test: To demonstrate that 11Pn co-administered with Infanrix hexa™ 1 month post-dose 3 was non-inferior for at least 9 out of 11 vaccine serotypes to Prevnar13 (for 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of Enzyme-linked immunosorbent assay (ELISA) GMCs. Criteria: UL of the 2-sided 95.9% CI of the ELISA GMC ratios (Prevnar13/11Pn) and (Synflorix/11Pn) groups \< a limit of 2-fold for at least 9 out of 11 vaccine pneumococcal serotypes.||1.15|0.81|
72439170|NCT01616459|144392348|NON_INFERIORITY_OR_EQUIVALENCE|GMCs ratio and its CI were calculated using an ANCOVA model on the logarithm-transformed concentrations, including the vaccine group as fixed effect and the pre-vaccination concentration as regressor. The GMCs were used to calculate the Adjusted GMCs (N=218 and Adjusted GMC =2.81 in the 11Pn Group and N= 201 and Adjusted GMC= 2.57 for the Synflorix Group) which in turn were used to calculate the Adjusted GMC ratio with 95.9% confidence interval.|Adjusted GMCs ratio|0.92|||||TWO_SIDED|95.9|0.74|1.14||||||ANTI-18C serotype test: To demonstrate that 11Pn co-administered with Infanrix hexa™ 1 month post-dose 3 was non-inferior for at least 9 out of 11 vaccine serotypes to Prevnar13 (for 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of Enzyme-linked immunosorbent assay (ELISA) GMCs. Criteria: UL of the 2-sided 95.9% CI of the ELISA GMC ratios (Prevnar13/11Pn) and (Synflorix/11Pn) groups \< a limit of 2-fold for at least 9 out of 11 vaccine pneumococcal serotypes.||1.14|0.74|
72439171|NCT01616459|144392348|NON_INFERIORITY_OR_EQUIVALENCE|GMCs ratio and its CI were calculated using an ANCOVA model on the logarithm-transformed concentrations, including the vaccine group as fixed effect and the pre-vaccination concentration as regressor. The GMCs were used to calculate the Adjusted GMCs (N=218 and Adjusted GMC = 3.70 in the 11Pn Group and N= 202 and Adjusted GMC= 3.68 for the Synflorix Group) which in turn were used to calculate the Adjusted GMC ratio with 95.9% confidence interval.|Adjusted GMCs ratio|1.0|||||TWO_SIDED|95.9|0.81|1.23||||||ANTI-19F serotype test: To demonstrate that 11Pn co-administered with Infanrix hexa™ 1 month post-dose 3 was non-inferior for at least 9 out of 11 vaccine serotypes to Prevnar13 (for 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of Enzyme-linked immunosorbent assay (ELISA) GMCs. Criteria: UL of the 2-sided 95.9% CI of the ELISA GMC ratios (Prevnar13/11Pn) and (Synflorix/11Pn) groups \< a limit of 2-fold for at least 9 out of 11 vaccine pneumococcal serotypes.||1.23|0.81|
72495429|NCT01340209|144519888|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.564|STANDARD_ERROR_OF_MEAN|1.038||0.5871|TWO_SIDED|95.0|-1.473|2.601|||Mixed Models Analysis|adjusted for treatment, week, baseline, treatment\*week and baseline\*week||Difference calculated as Tiotropium 5 μg minus placebo||2.601|-1.473|0.5871
72439172|NCT01616459|144392348|NON_INFERIORITY_OR_EQUIVALENCE|GMCs ratio and its CI were calculated using an ANCOVA model on the logarithm-transformed concentrations, including the vaccine group as fixed effect and the pre-vaccination concentration as regressor. The GMCs were used to calculate the Adjusted GMCs (N=218 and Adjusted GMC = 0.62 in the 11Pn Group and N= 199 and Adjusted GMC= 0.71 for the Synflorix Group) which in turn were used to calculate the Adjusted GMC ratio with 95.9% confidence interval.|Adjusted GMCs ratio|1.15|||||TWO_SIDED|95.9|0.89|1.48||||||ANTI-23F serotype test: To demonstrate that 11Pn co-administered with Infanrix hexa™ 1 month post-dose 3 was non-inferior for at least 9 out of 11 vaccine serotypes to Prevnar13 (for 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of Enzyme-linked immunosorbent assay (ELISA) GMCs. Criteria: UL of the 2-sided 95.9% CI of the ELISA GMC ratios (Prevnar13/11Pn) and (Synflorix/11Pn) groups \< a limit of 2-fold for at least 9 out of 11 vaccine pneumococcal serotypes.||1.48|0.89|
72618905|NCT01260324|144768305|SUPERIORITY_OR_OTHER_LEGACY||Incidence rate per 1000 person-years|0.03|||||TWO_SIDED|95.0|0.01|0.04|||||Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.|Incidence rate Recent PDE-5 inhibitors use||0.04|0.01|
72439173|NCT01616459|144392348|NON_INFERIORITY_OR_EQUIVALENCE|GMCs ratio and its CI were calculated using an ANCOVA model on the logarithm-transformed concentrations/titres, including the vaccine group as fixed effect and the pre-vaccination concentration as regressor. The GMCs were used to calculate the Adjusted GMCs (N=217 and Adjusted GMC =1.61 in the 11Pn Group and N= 206 and Adjusted GMC= 2.75 for the Prevnar13 Group) which in turn were used to calculate the Adjusted GMC ratio with 95.9% confidence interval.|Adjusted GMCs ratio|1.71|||||TWO_SIDED|95.9|1.44|2.03||||||ANTI-19A serotype test: To demonstrate that 11Pn co-administered with Infanrix hexa™ 1 month post-dose 3 was non-inferior for at least 9 out of 11 vaccine serotypes to Prevnar13 (for 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of Enzyme-linked immunosorbent assay (ELISA) GMCs. Criteria: UL of the 2-sided 95.9% CI of the ELISA GMC ratios (Prevnar13/11Pn) and (Synflorix/11Pn) groups \< a limit of 2-fold for at least 9 out of 11 vaccine pneumococcal serotypes.||2.03|1.44|
72618906|NCT01260324|144768305|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.82|||||TWO_SIDED|95.0|1.47|2.25|||||Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.|Odds ratio Diabetes||2.25|1.47|
72618907|NCT01260324|144768305|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.34|||||TWO_SIDED|95.0|0.63|2.85|||||Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.|Odds ratio Smoking||2.85|0.63|
72439174|NCT01616459|144392348|NON_INFERIORITY_OR_EQUIVALENCE|12-valent formulation objectives to be assessed sequentially after demonstration for 11-valent formulation. GMCs ratio and its CI obtained using ANCOVA model on logarithm-transformed concentrations, including vaccine group as fixed effect and pre-vaccination concentration as regressor. GMCs were used to calculate Adjusted GMCs (N=207 and Adj. GMC =1.58 in 12Pn Group and N= 203 and Adj. GMC= 1.35 for Synflorix Group) which in turn were used to calculate Adjusted GMC ratio with 95.8% CI.|Adjusted GMCs ratio|0.86||||||95.8|0.72|1.02||||||ANTI-1 serotype test: To demonstrate that 12Pn co-administered with Infanrix hexa™ 1 month post-dose 3 was non-inferior for at least 10 out of 12 vaccine serotypes to Prevnar13 (for 6A \& 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of Enzyme-linked immunosorbent assay (ELISA) GMCs. Criteria: UL of the 2-sided 95.8 CI of the ELISA GMC ratios (Prevnar13/12Pn) and (Synflorix/12Pn) groups \< a limit of 2-fold for at least 10 out of 12 vaccine pneumococcal serotypes.||1.02|0.72|
72439175|NCT01616459|144392348|NON_INFERIORITY_OR_EQUIVALENCE|12-valent formulation objectives to be assessed sequentially after demonstration for 11-valent formulation. GMCs ratio and its CI obtained using ANCOVA model on logarithm-transformed concentrations, including vaccine group as fixed effect and pre-vaccination concentration as regressor. GMCs were used to calculate Adjusted GMCs (N=208 and Adj. GMC =1.94 in 12Pn Group and N= 203 and Adj. GMC= 1.66 for Synflorix Group) which in turn were used to calculate Adjusted GMC ratio with 95.8% CI.|Adjusted GMCs ratio|0.86||||||95.8|0.7|1.05||||||ANTI-4 serotype test: To demonstrate that 12Pn co-administered with Infanrix hexa™ 1 month post-dose 3 was non-inferior for at least 10 out of 12 vaccine serotypes to Prevnar13 (for 6A \& 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of Enzyme-linked immunosorbent assay (ELISA) GMCs. Criteria: UL of the 2-sided 95.8 CI of the ELISA GMC ratios (Prevnar13/12Pn) and (Synflorix/12Pn) groups \< a limit of 2-fold for at least 10 out of 12 vaccine pneumococcal serotypes.||1.05|0.70|
72439176|NCT01616459|144392348|NON_INFERIORITY_OR_EQUIVALENCE|12-valent formulation objectives to be assessed sequentially after demonstration for 11-valent formulation. GMCs ratio and its CI obtained using ANCOVA model on logarithm-transformed concentrations, including vaccine group as fixed effect and pre-vaccination concentration as regressor. GMCs were used to calculate Adjusted GMCs (N=208 and Adj. GMC =2.37 in 12Pn Group and N= 201 and Adj. GMC= 2.16 for Synflorix Group) which in turn were used to calculate Adjusted GMC ratio with 95.8% CI.|Adjusted GMCs ratio|0.91|||||TWO_SIDED|95.8|0.78|1.07||||||ANTI-5 serotype test: To demonstrate that 12Pn co-administered with Infanrix hexa™ 1 month post-dose 3 was non-inferior for at least 10 out of 12 vaccine serotypes to Prevnar13 (for 6A \& 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of Enzyme-linked immunosorbent assay (ELISA) GMCs. Criteria: UL of the 2-sided 95.8 CI of the ELISA GMC ratios (Prevnar13/12Pn) and (Synflorix/12Pn) groups \< a limit of 2-fold for at least 10 out of 12 vaccine pneumococcal serotypes.||1.07|0.78|
72495430|NCT01394705|144519901|SUPERIORITY|||||||0.65|||||||Fisher Exact|||||||.65
72495431|NCT01394705|144519901|SUPERIORITY|||||||0.65|||||||Wilcoxon (Mann-Whitney)|||||||0.65
72618908|NCT01260324|144768305|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.43|||||TWO_SIDED|95.0|0.23|0.81|||||Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.|Odds ratio Obesity||0.81|0.23|
72618909|NCT01260324|144768305|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.63|||||TWO_SIDED|95.0|0.42|0.94|||||Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.|Odds ratio Nitrates||0.94|0.42|
72495432|NCT01394705|144519902|SUPERIORITY|||||||0.76|||||||Wilcoxon (Mann-Whitney)|||||||0.76
72618910|NCT01260324|144768305|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.12|||||TWO_SIDED|95.0|1.53|2.94|||||Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.|Odds ratio Anti-platelet agents||2.94|1.53|
72618911|NCT01260324|144768305|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.24|||||TWO_SIDED|95.0|1.46|3.43|||||Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.|Odds ratio Diuretics||3.43|1.46|
72618912|NCT01260324|144768305|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.57|||||TWO_SIDED|95.0|0.31|1.04|||||Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.|Odds ratio Recent PDE-5 inhibitors use||1.04|0.31|
72439177|NCT01616459|144392348|NON_INFERIORITY_OR_EQUIVALENCE|12-valent formulation objectives to be assessed sequentially after demonstration for 11-valent formulation. GMCs ratio and its CI obtained using ANCOVA model on logarithm-transformed concentrations, including vaccine group as fixed effect and pre-vaccination concentration as regressor. GMCs were used to calculate Adjusted GMCs (N=208 and Adj. GMC =0.56 in 12Pn Group and N= 200 and Adj. GMC= 0.47 for Synflorix Group) which in turn were used to calculate Adjusted GMC ratio with 95.8% CI.|Adjusted GMCs ratio|0.84||||||95.8|0.64|1.11||||||ANTI-6B serotype test: To demonstrate that 12Pn co-administered with Infanrix hexa™ 1 month post-dose 3 was non-inferior for at least 10 out of 12 vaccine serotypes to Prevnar13 (for 6A \& 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of Enzyme-linked immunosorbent assay (ELISA) GMCs. Criteria: UL of the 2-sided 95.8 CI of the ELISA GMC ratios (Prevnar13/12Pn) and (Synflorix/12Pn) groups \< a limit of 2-fold for at least 10 out of 12 vaccine pneumococcal serotypes.||1.11|0.64|
72618913|NCT01260324|144768306|SUPERIORITY_OR_OTHER_LEGACY||Incidence rate per 1000 person-years|0.33|||||TWO_SIDED|95.0|0.28|0.39|||||Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.|Incidence rate Other retinal disorders||0.39|0.28|
72386565|NCT01999868|144281224|SUPERIORITY|||||||0.16||||||Two-sided test.|Regression, Logistic|Randomization stratum (PASI score at week 0: 12-20 or \>20) and duration of disease prior to screening, centered about the median, are covariates.||Week 12 to 88. This interval corresponds to the time from randomization until the end of the study.||||0.16
72386566|NCT01999868|144281224|SUPERIORITY|||||||0.002||||||Two-sided test.|Regression, Logistic|Randomization stratum (PASI score at week 0: 12-20 or \>20) and duration of disease prior to screening, centered about the median, are covariates.||Week 12 to 40. This interval corresponds to the time from randomization until the end of the blinded treatment phase.||||0.002
72386567|NCT01999868|144281224|SUPERIORITY|||||||0.23||||||Two-sided test.|Regression, Logistic|Randomization stratum (PASI score at week 0: 12-20 or \>20) and duration of disease prior to screening, centered about the median, are covariates.||Week 28 to 88. This interval corresponds to the time from the last scheduled dose of ustekinumab or ustekinumab placebo until the end of the study.||||0.23
72386568|NCT01999868|144281224|SUPERIORITY|||||||0.43||||||Two-sided test.|Regression, Logistic|Randomization stratum (PASI score at week 0: 12-20 or \>20) and duration of disease prior to screening, centered about the median, are covariates.||Week 40 to 88. This interval corresponds to the time from the beginning of the blinded observation phase until the end of the study.||||0.43
72386569|NCT01999868|144281225|SUPERIORITY|||||||0.06||||||Two-sided test.|Grouped survival analysis|Randomization stratum (PASI score at week 0: 12-20 or \>20) and duration of disease prior to screening, centered about the median, are covariates.||Week 12 to 88. This interval corresponds to the time from randomization until the end of the study.||||0.06
72386570|NCT01999868|144281225|SUPERIORITY|||||||0.008||||||Two-sided test.|Grouped survival analysis|Randomization stratum (PASI score at week 0: 12-20 or \>20) and duration of disease prior to screening, centered about the median, are covariates.||Week 12 to 40. This interval corresponds to the time from randomization until the end of the blinded treatment phase.||||0.008
72386571|NCT01999868|144281226|SUPERIORITY|||||||0.005||||||Two-sided test.|Grouped survival analysis|Randomization stratum (PASI score at week 0: 12-20 or \>20) and duration of disease prior to screening, centered about the median, are covariates.||Week 12 to 88. This interval corresponds to the time from randomization until the end of the study.||||0.005
72386572|NCT01999868|144281226|SUPERIORITY|||||||0.001||||||Two-sided test.|Grouped survival analysis|Randomization stratum (PASI score at week 0: 12-20 or \>20) and duration of disease prior to screening, centered about the median, are covariates.||Week 12 to 40. This interval corresponds to the time from randomization until the end of the blinded treatment phase.||||0.001
72386573|NCT01999868|144281227|SUPERIORITY|||||||0.013||||||Two-sided test.|Regression, Logistic|Randomization stratum (PASI score at week 0: 12-20 or \>20) and duration of disease prior to screening, centered about the median, are covariates.||Week 40||||0.013
72386574|NCT01999868|144281227|SUPERIORITY|||||||0.95|||||||Regression, Logistic|Randomization stratum (PASI score at week 0: 12-20 or \>20) and duration of disease prior to screening, centered about the median, are covariates.||Week 88||||0.95
72386575|NCT01999868|144281228|SUPERIORITY|||||||0.18||||||Two-sided test.|ANCOVA|Randomization stratum (PASI score at week 0: 12-20 or \>20), baseline DLQI, and pre-screening disease duration, centered on the median, are covariates.||Week 12 to 40||||0.18
72386576|NCT01999868|144281228|SUPERIORITY|||||||0.045||||||Two-sided test.|ANCOVA|Randomization (PASI score week 0:12-20 or \>20), DLQI score at baseline, duration of disease prior to screening, centered about median, are covariates||Week 12 to 88||||0.045
72386577|NCT00502944|144281233|SUPERIORITY_OR_OTHER||Rate Difference (%)|30.0|||<|0.001|TWO_SIDED|95.0|27.0|32.0|||Chi-squared|||HIV test completed among patients randomized||32|27|<0.001
72386578|NCT00502944|144281234|SUPERIORITY_OR_OTHER||Rate Difference (%)|44.0|||<|0.001|TWO_SIDED|95.0|42.0|47.0|||Chi-squared|||HIV test offered||47|42|<0.001
72386579|NCT00502944|144281235|SUPERIORITY_OR_OTHER||Rate Difference (%)|-4.0||||0.02|TWO_SIDED|95.0|-8.0|-1.0|||Chi-squared|||HIV test accepted among patients offered||-1|-8|0.02
72386580|NCT00310401|144281237|SUPERIORITY_OR_OTHER|||||||0.98||95.0|||||Paired T Test|||Paired T Test was used to compare the change in PaO2/FiO2 ratio from enrollment to procurement between albuterol and saline treated donors||||0.98
72386581|NCT00319501|144281248|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.55||||0.012|TWO_SIDED|95.0|0.34|0.88||p-value is adjusted. All statistical tests were 2-sided and employed a level of significance of alpha=0.05.|Cox Proportional Hazard||Age adjusted|Null hypothesis||0.88|0.34|0.012
72386582|NCT00319501|144281250|SUPERIORITY_OR_OTHER|||||||0.066|TWO_SIDED|||||p-value is unadjusted. All statistical tests were 2-sided and employed a level of significance of alpha=0.05.|Fisher Exact|||||||0.066
72386583|NCT00319501|144281251|SUPERIORITY_OR_OTHER|||||||0.443|||||||Fisher Exact|||||||0.443
72386584|NCT00319501|144281252|SUPERIORITY_OR_OTHER|||||||0.245|TWO_SIDED|||||p-value is unadjusted. All statistical tests were 2-sided and employed a level of significance of alpha=0.05.|Fisher Exact|||||||0.245
72439178|NCT01616459|144392348|NON_INFERIORITY_OR_EQUIVALENCE|12-valent formulation objectives to be assessed sequentially after demonstration for 11-valent formulation. GMCs ratio and its CI obtained using ANCOVA model on logarithm-transformed concentrations, including vaccine group as fixed effect and pre-vaccination concentration as regressor. GMCs were used to calculate Adjusted GMCs (N=211 and Adj. GMC =2.42 in 12Pn Group and N= 202 and Adj. GMC= 2.17 for Synflorix Group) which in turn were used to calculate Adjusted GMC ratio with 95.8% CI.|Adjusted GMCs ratio|0.9|||||TWO_SIDED|95.8|0.76|1.06||||||ANTI-7F serotype test: To demonstrate that 12Pn co-administered with Infanrix hexa™ 1 month post-dose 3 was non-inferior for at least 10 out of 12 vaccine serotypes to Prevnar13 (for 6A \& 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of Enzyme-linked immunosorbent assay (ELISA) GMCs. Criteria: UL of the 2-sided 95.8 CI of the ELISA GMC ratios (Prevnar13/12Pn) and (Synflorix/12Pn) groups \< a limit of 2-fold for at least 10 out of 12 vaccine pneumococcal serotypes.||1.06|0.76|
72439179|NCT01616459|144392348|NON_INFERIORITY_OR_EQUIVALENCE|12-valent formulation objectives to be assessed sequentially after demonstration for 11-valent formulation. GMCs ratio and its CI obtained using ANCOVA model on logarithm-transformed concentrations, including vaccine group as fixed effect and pre-vaccination concentration as regressor. GMCs were used to calculate Adjusted GMCs (N=208 and Adj. GMC =1.78 in 12Pn Group and N= 200 and Adj. GMC= 1.40 for Synflorix Group) which in turn were used to calculate Adjusted GMC ratio with 95.8% CI.|Adjusted GMCs ratio|0.79|||||TWO_SIDED|95.8|0.67|0.93||||||ANTI-9V serotype test: To demonstrate that 12Pn co-administered with Infanrix hexa™ 1 month post-dose 3 was non-inferior for at least 10 out of 12 vaccine serotypes to Prevnar13 (for 6A \& 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of Enzyme-linked immunosorbent assay (ELISA) GMCs. Criteria: UL of the 2-sided 95.8 CI of the ELISA GMC ratios (Prevnar13/12Pn) and (Synflorix/12Pn) groups \< a limit of 2-fold for at least 10 out of 12 vaccine pneumococcal serotypes.||0.93|0.67|
72439180|NCT01616459|144392348|NON_INFERIORITY_OR_EQUIVALENCE|12-valent formulation objectives to be assessed sequentially after demonstration for 11-valent formulation. GMCs ratio and its CI obtained using ANCOVA model on logarithm-transformed concentrations, including vaccine group as fixed effect and pre-vaccination concentration as regressor. GMCs were used to calculate Adjusted GMCs (N=209 and Adj. GMC =4.48 in 12Pn Group and N= 201 and Adj. GMC= 4.10 for Synflorix Group) which in turn were used to calculate Adjusted GMC ratio with 95.8% CI.|Adjusted GMCs ratio|0.91|||||TWO_SIDED|95.8|0.77|1.09||||||ANTI-14 serotype test: To demonstrate that 12Pn co-administered with Infanrix hexa™ 1 month post-dose 3 was non-inferior for at least 10 out of 12 vaccine serotypes to Prevnar13 (for 6A \& 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of Enzyme-linked immunosorbent assay (ELISA) GMCs. Criteria: UL of the 2-sided 95.8 CI of the ELISA GMC ratios (Prevnar13/12Pn) and (Synflorix/12Pn) groups \< a limit of 2-fold for at least 10 out of 12 vaccine pneumococcal serotypes.||1.09|0.77|
72439181|NCT01616459|144392348|NON_INFERIORITY_OR_EQUIVALENCE|12-valent formulation objectives to be assessed sequentially after demonstration for 11-valent formulation. GMCs ratio and its CI obtained using ANCOVA model on logarithm-transformed concentrations, including vaccine group as fixed effect and pre-vaccination concentration as regressor. GMCs were used to calculate Adjusted GMCs (N=209 and Adj. GMC =2.55 in 12Pn Group and N= 201 and Adj. GMC= 2.57 for Synflorix Group) which in turn were used to calculate Adjusted GMC ratio with 95.8% CI.|Adjusted GMCs ratio|1.01|||||TWO_SIDED|95.8|0.81|1.26||||||ANTI-18C serotype test: To demonstrate that 12Pn co-administered with Infanrix hexa™ 1 month post-dose 3 was non-inferior for at least 10 out of 12 vaccine serotypes to Prevnar13 (for 6A \& 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of Enzyme-linked immunosorbent assay (ELISA) GMCs. Criteria: UL of the 2-sided 95.8 CI of the ELISA GMC ratios (Prevnar13/12Pn) and (Synflorix/12Pn) groups \< a limit of 2-fold for at least 10 out of 12 vaccine pneumococcal serotypes.||1.26|0.81|
72439182|NCT01616459|144392348|NON_INFERIORITY_OR_EQUIVALENCE|12-valent formulation objectives to be assessed sequentially after demonstration for 11-valent formulation. GMCs ratio and its CI obtained using ANCOVA model on logarithm-transformed concentrations, including vaccine group as fixed effect and pre-vaccination concentration as regressor. GMCs were used to calculate Adjusted GMCs (N=211 and Adj. GMC =3.29 in 12Pn Group and N= 202 and Adj. GMC= 3.67 for Synflorix Group) which in turn were used to calculate Adjusted GMC ratio with 95.8% CI.|Adjusted GMCs ratio|1.12|||||TWO_SIDED|95.8|0.9|1.38||||||ANTI-19F serotype test: To demonstrate that 12Pn co-administered with Infanrix hexa™ 1 month post-dose 3 was non-inferior for at least 10 out of 12 vaccine serotypes to Prevnar13 (for 6A \& 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of Enzyme-linked immunosorbent assay (ELISA) GMCs. Criteria: UL of the 2-sided 95.8 CI of the ELISA GMC ratios (Prevnar13/12Pn) and (Synflorix/12Pn) groups \< a limit of 2-fold for at least 10 out of 12 vaccine pneumococcal serotypes.||1.38|0.90|
72439183|NCT01616459|144392348|NON_INFERIORITY_OR_EQUIVALENCE|12-valent formulation objectives to be assessed sequentially after demonstration for 11-valent formulation. GMCs ratio and its CI obtained using ANCOVA model on logarithm-transformed concentrations, including vaccine group as fixed effect and pre-vaccination concentration as regressor. GMCs were used to calculate Adjusted GMCs (N=208 and Adj. GMC =0.68 in 12Pn Group and N= 199 and Adj. GMC= 0.71 for Synflorix Group) which in turn were used to calculate Adjusted GMC ratio with 95.8% CI..|Adjusted GMCs ratio|1.05|||||TWO_SIDED|95.8|0.81|1.37||||||ANTI-23F serotype test: To demonstrate that 12Pn co-administered with Infanrix hexa™ 1 month post-dose 3 was non-inferior for at least 10 out of 12 vaccine serotypes to Prevnar13 (for 6A \& 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of Enzyme-linked immunosorbent assay (ELISA) GMCs. Criteria: UL of the 2-sided 95.8 CI of the ELISA GMC ratios (Prevnar13/12Pn) and (Synflorix/12Pn) groups \< a limit of 2-fold for at least 10 out of 12 vaccine pneumococcal serotypes.||1.37|0.81|
72439184|NCT01616459|144392348|NON_INFERIORITY_OR_EQUIVALENCE|12-valent formulation objectives to be assessed sequentially after demonstration for 11-valent formulation. GMCs ratio and its CI obtained using ANCOVA model on logarithm-transformed concentrations, including vaccine group as fixed effect and pre-vaccination concentration as regressor. GMCs were used to calculate Adjusted GMCs (N=210 and Adj. GMC =1.09 in 12Pn Group and N= 214 and Adj. GMC= 2.07 for Prevnar13 Group) which in turn were used to calculate Adjusted GMC ratio with 95.8% CI.|Adjusted GMCs ratio|1.9|||||TWO_SIDED|95.8|1.51|2.39||||||ANTI-6A serotype test: To demonstrate that 12Pn co-administered with Infanrix hexa™ 1 month post-dose 3 was non-inferior for at least 10 out of 12 vaccine serotypes to Prevnar13 (for 6A\&19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of Enzyme-linked immunosorbent assay (ELISA) GMCs. Criteria: UL of the 2-sided 95.8 CI of the ELISA GMC ratios (Prevnar13/12Pn) and (Synflorix/12Pn) groups \< a limit of 2-fold for at least 10 out of 12 vaccine pneumococcal serotypes.||2.39|1.51|
72495433|NCT00094757|144519919|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.6|STANDARD_DEVIATION|0.9|<|0.001|TWO_SIDED|95.0|-0.82|-0.39||Model terms: treatment, baseline, prior anti-hyperglycemic therapy status (on vs. not on prior therapy)|ANCOVA|||||-0.39|-0.82|<0.001
72386585|NCT00319501|144281253|SUPERIORITY_OR_OTHER||Difference in least square means|0.75||||0.086|TWO_SIDED|95.0|-0.11|1.61||p-Value is unadjusted. All statistical tests were 2-sided and employed a level of significance of alpha = 0.05.|ANOVA|ANOVA=analysis of variance.|Model included treatment and age category.|||1.61|-0.11|0.086
72386586|NCT00319501|144281254|SUPERIORITY_OR_OTHER||Difference in least square means|0.79||||0.045|TWO_SIDED|95.0|0.02|1.56||p-value is unadjusted. All statistical tests were 2-sided and employed a level of significance of alpha=0.05.|ANOVA||Model included treatment and age category.|||1.56|0.02|0.045
72386587|NCT03572972|144281277|SUPERIORITY||Hazard Ratio (HR)|0.618|||||TWO_SIDED|95.0|0.541|0.707||||||Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of hazard ratio (HR) at year 1 as an extended Cox model was used.||0.707|0.541|
72386588|NCT03572972|144281277|SUPERIORITY||Hazard Ratio (HR)|0.604|||||TWO_SIDED|95.0|0.53|0.687||||||Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.||0.687|0.530|
72386589|NCT03572972|144281277|SUPERIORITY||Hazard Ratio (HR)|0.705|||||TWO_SIDED|95.0|0.563|0.884|||||HR evaluated using extended Cox model.|Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.||0.884|0.563|
72386590|NCT03572972|144281278|SUPERIORITY||Hazard Ratio (HR)|0.993|||||TWO_SIDED|95.0|0.87|1.134||||||Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.||1.134|0.870|
72386591|NCT03572972|144281278|SUPERIORITY||Hazard Ratio (HR)|0.949|||||TWO_SIDED|95.0|0.839|1.073||||||Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.||1.073|0.839|
72386592|NCT03572972|144281278|SUPERIORITY||Hazard Ratio (HR)|0.961|||||TWO_SIDED|95.0|0.854|1.082||||||Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.||1.082|0.854|
72386593|NCT03572972|144281279|SUPERIORITY||Hazard Ratio (HR)|0.583|||||TWO_SIDED|95.0|0.512|0.664||||||Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.||0.664|0.512|
72386594|NCT03572972|144281279|SUPERIORITY||Hazard Ratio (HR)|0.754|||||TWO_SIDED|95.0|0.597|0.953|||||HR evaluated using extended Cox model.|Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.||0.953|0.597|
72386595|NCT03572972|144281279|SUPERIORITY||Hazard Ratio (HR)|0.844|||||TWO_SIDED|95.0|0.685|1.04|||||HR evaluated using extended Cox model.|Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.||1.040|0.685|
72386596|NCT03572972|144281280|SUPERIORITY||Hazard Ratio (HR)|0.866|||||TWO_SIDED|95.0|0.761|0.985||||||Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.||0.985|0.761|
72495434|NCT00094757|144519919|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.48|STANDARD_DEVIATION|0.9|<|0.001|TWO_SIDED|95.0|-0.7|-0.26|||ANCOVA|Model terms: treatment, baseline, prior anti-hyperglycemic therapy status (on vs. not on prior therapy)||||-0.26|-0.70|<0.001
72495435|NCT00094757|144519920|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-19.7|STANDARD_DEVIATION|45.9|<|0.001|TWO_SIDED|95.0|-30.5|-8.9|||ANCOVA|Model terms: treatment, baseline, prior anti-hyperglycemic therapy status||||-8.9|-30.5|<0.001
72495436|NCT00094757|144519920|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-16.9|STANDARD_DEVIATION|45.9|<|0.002|TWO_SIDED|95.0|-27.6|-6.1|||ANCOVA|Model terms: treatment, baseline, prior anti-hyperglycemic therapy status||||-6.1|-27.6|<0.002
72495437|NCT00756938|144519923|SUPERIORITY_OR_OTHER_LEGACY||Slope|1.22||||0.753|TWO_SIDED|95.0|-6.45|8.9|||ANCOVA|Analysis of covariance (ANCOVA) model with terms for dose, weight (as a continuous covariate) and presence of co-morbidities/end organ damage||||8.90|-6.45|0.753
72558805|NCT00840658|144647621|SUPERIORITY|||||||0.036|TWO_SIDED|95.0||||P-value is for the Ciudad Juarez site and it corresponds to the interaction between group (Intervention vs. Control) and study visit (12-months vs. baseline).|Mixed Models Analysis|||Alternative hypothesis: There is a difference between the intervention and the control group with respect to the change in the odds of higher receptive needle sharing. (i.e., The interaction between study visit (baseline, 4-, 8-, and 12-months) and intervention group will be significant at 0.05 significance level. Over time, the intervention group will experience a significant decline in receptive needle sharing but the control group will not.)|To examine the receptive needle sharing outcome, we used ordinal logistic regression for correlated data via GEE with the correlation matrix estimated empirically from the data. The final analyses were stratified by site. The final ordinal logistic regression models included the following main effects: Group, Visit, and Visit\*Group interaction, with our primary interest in the Visit\*Group interaction, as a significant p-value would be indicative of an intervention effect.|||0.036
72495438|NCT00756938|144519924|SUPERIORITY_OR_OTHER_LEGACY||Slope|1.81||||0.643|TWO_SIDED|95.0|-5.9|9.51|||ANCOVA|Analysis of covariance (ANCOVA) model with terms for dose, weight (as a continuous covariate) and presence of co-morbidities/end organ damage||||9.51|-5.90|0.643
72495439|NCT04317274|144519927|OTHER||Slope|-0.19||||0.21|TWO_SIDED||||||Mixed Models Analysis|Note: original plan was to conduct ANOVAs, but failed tests of assumptions||We tested for interaction effect of order and video version within the high cholesterol group.||||0.21
72495440|NCT04317274|144519927|OTHER||Slope|-1.23|||<|0.001|TWO_SIDED||||||Mixed Models Analysis|Original plan was to conduct ANOVAs, but failed tests of assumptions||We tested for interaction effect of order and video version within the colorectal cancer group.||||<0.001
72495441|NCT04317274|144519928|OTHER||Slope|0.58|||<|0.001|TWO_SIDED||||||Pearson's correlation coefficient|||We examined the correlation between SDM Process and SDM-Q9 scores in the high cholesterol group.||||<.001
72495442|NCT04317274|144519928|OTHER||Slope|0.71|||<|0.001|TWO_SIDED||||||Pearson's correlation coefficient]|||We examined the correlation between SDM Process and SDM-Q9 scores in the colorectal cancer group.||||<.001
72495443|NCT02551159|144519955|SUPERIORITY||Hazard Ratio (HR)|0.96||||0.787|TWO_SIDED|95.0|0.69|1.32||2 sided|Log Rank|||Statistical analysis of number of deaths||1.32|0.69|0.787
72618914|NCT01260324|144768306|SUPERIORITY_OR_OTHER_LEGACY||Incidence rate per 1000 person-years|0.13|||||TWO_SIDED|95.0|0.11|0.16|||||Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.|Incidence rate Glaucoma||0.16|0.11|
72618915|NCT01260324|144768306|SUPERIORITY_OR_OTHER_LEGACY||Incidence rate per 1000 person-years|0.2|||||TWO_SIDED|95.0|0.08|0.41|||||Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.|Incidence rate Cataract||0.41|0.08|
72495444|NCT02551159|144519957|SUPERIORITY||Hazard Ratio (HR)|1.05||||0.634|TWO_SIDED|95.0|0.8|1.39||2 sided|Log Rank|||||1.39|0.80|0.634
72495445|NCT02551159|144519959|SUPERIORITY||Hazard Ratio (HR)|1.3||||0.287|TWO_SIDED|95.0|0.94|1.8||2 sided|Log Rank|||||1.80|0.94|0.287
72495446|NCT02551159|144519959|SUPERIORITY||Hazard Ratio (HR)|1.32||||0.028|TWO_SIDED|95.0|0.99|1.76||2 sided|Log Rank|||||1.76|0.99|0.028
72495447|NCT02551159|144519960|SUPERIORITY||Odds Ratio (OR)|0.19|||<|0.001|TWO_SIDED|95.0|0.1|0.37||2 sided|Regression, Logistic|||Statistical analysis of number with a response||0.37|0.10|<0.001
72495448|NCT02551159|144519960|SUPERIORITY||Odds Ratio (OR)|0.34|||<|0.001|TWO_SIDED|95.0|0.2|0.57||2 sided|Regression, Logistic|||Statistical analysis of number with a response||0.57|0.20|<0.001
72495449|NCT02551159|144519962|SUPERIORITY||Hazard Ratio (HR)|1.03||||0.811|TWO_SIDED|95.0|0.83|1.27||2 sided|Log Rank|||Statistical analysis of number of deaths||1.27|0.83|0.811
72495450|NCT02551159|144519962|SUPERIORITY||Hazard Ratio (HR)|1.04||||0.624|TWO_SIDED|95.0|0.87|1.25|||Log Rank|||Statistical analysis of number of deaths||1.25|0.87|0.624
72495451|NCT02551159|144519965|SUPERIORITY||Hazard Ratio (HR)|1.36||||0.006|TWO_SIDED|95.0|1.1|1.68||2 sided|Log Rank|||||1.68|1.10|0.006
72495452|NCT02551159|144519965|SUPERIORITY||Hazard Ratio (HR)|1.27||||0.008|TWO_SIDED|95.0|1.06|1.53||2 sided|Log Rank|||||1.53|1.06|0.008
72495453|NCT02551159|144519966|SUPERIORITY||Odds Ratio (OR)|0.21|||<|0.001|TWO_SIDED|95.0|0.13|0.33||2 sided|Regression, Logistic|||||0.33|0.13|<0.001
72495454|NCT02551159|144519966|SUPERIORITY||Odds Ratio (OR)|0.29|||<|0.001|TWO_SIDED|95.0|0.2|0.41||2 sided|Regression, Logistic|||||0.41|0.20|<0.001
72495455|NCT02175680|144519968|SUPERIORITY||||||<|0.0001|||||||Wilcoxon Rank Sum|The time to Virologic Failure for the subjects treated with PRO 140 monotherapy was compared to historical data.|||The median time to Virologic Failure for historical controls was 29 days.|||<0.0001
72495456|NCT01493180|144519997|SUPERIORITY_OR_OTHER|||||||0.576|||||||t-test, 2 sided|||||||0.576
72495457|NCT03179436|144520007|OTHER||Percent Difference|2.4|||||TWO_SIDED|95.0|-8.7|14.1|||Percent Difference|Comparision based on Miettinen \& Nurminen method||||14.1|-8.7|
72495458|NCT04247425|144520098|SUPERIORITY|||||||0.59|||||||Wilcoxon (Mann-Whitney)|||Baseline compared to end of 12 week exercise intervention||||0.59
72495459|NCT04247425|144520099|SUPERIORITY|||||||0.02|||||||Wilcoxon (Mann-Whitney)|||Baseline compared to end of 12 week exercise intervention||||0.02
72495460|NCT04247425|144520100|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Baseline compared to end of 12 week exercise intervention||||1.0
72495461|NCT04247425|144520101|SUPERIORITY|||||||0.09|||||||Wilcoxon (Mann-Whitney)|||Baseline compared to end of 12 week exercise intervention||||0.09
72495462|NCT00762515|144520117|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||ANCOVA|baseline is used a factor||The null hypothesis states that there is no difference between groups.||||<0.05
72495463|NCT00762515|144520118|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||ANCOVA|baseline to be used a factor||The null hypothesis states that there is no difference between groups.||||<0.05
72495464|NCT01582308|144520139|SUPERIORITY_OR_OTHER||Least squares mean difference|18.24|||<|0.001|TWO_SIDED|90.0|14.97|21.67||P-value of between-treatment comparison of percent inhibition of DPP-4 activity.|Linear mixed effects model|||Analysis model included fixed effects terms for treatment and period.||21.67|14.97|<.001
72558806|NCT00840658|144647622|SUPERIORITY|||||||0.013|TWO_SIDED|95.0||||P-value is for the Ciudad Juarez site and it corresponds to the interaction between group (Intervention vs. Control) and study visit (12-months vs. baseline).|Mixed Models Analysis|||Alternative hypothesis: There is a difference between the intervention and the control group with respect to the change in the mean score IRI (i.e., The interaction between study visit (baseline, 4-, 8-, and 12-months) and intervention group will be significant at 0.05 significance level. Over time, the intervention group will experience a significant decline in the IRI but the control group will not.)|We used gamma regression for correlated data via GEE, with the correlation matrix estimated empirically from the data. The final analyses were stratified by site. The final gamma regression models included the following main effects: Group, Visit, and Visit\*Group interaction, with our primary interest in the Visit\*Group interaction, as a significant p-value would be indicative of an intervention effect.|||0.013
72558807|NCT00474058|144647631|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.55||||0.0002||95.0|-5.37|-1.73||No p-value adjustment was necessary, since a multiple test procedure in a hierarchical sequentially rejective manner for the primary variable was applied.|ANCOVA|||Analyses of covariance were performed for the efficacy variables with treatment and (pooled) sites as factors, and baseline value as covariate. Least square means (LS means) for treatment effect were calculated and differences between rotigotine and placebo were presented with 95% confidence intervals (CIs) and p- values.||-1.73|-5.37|0.0002
72439185|NCT01616459|144392348|NON_INFERIORITY_OR_EQUIVALENCE|12-valent formulation objectives to be assessed sequentially after demonstration for 11-valent formulation. GMCs ratio and its CI obtained using ANCOVA model on logarithm-transformed concentrations, including vaccine group as fixed effect and pre-vaccination concentration as regressor. GMCs were used to calculate Adjusted GMCs (N=208 and Adj. GMC =1.19 in 12Pn Group and N= 206 and Adj. GMC= 2.76 for Prevnar13 Group) which in turn were used to calculate Adjusted GMC ratio with 95.8% CI.|Adjusted GMCs ratio|2.32|||||TWO_SIDED|95.8|1.94|2.77||||||ANTI-19A serotype test: To demonstrate that 12Pn co-administered with Infanrix hexa™ 1 month post-dose 3 was non-inferior for at least 10 out of 12 vaccine serotypes to Prevnar13 (for 6A\&19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of Enzyme-linked immunosorbent assay (ELISA) GMCs. Criteria: UL of the 2-sided 95.8 CI of the ELISA GMC ratios (Prevnar13/12Pn) and (Synflorix/12Pn) groups \< a limit of 2-fold for at least 10 out of 12 vaccine pneumococcal serotypes.||2.77|1.94|
72439186|NCT01616459|144392349|NON_INFERIORITY_OR_EQUIVALENCE|2-sided 95.9 % Confidence Interval (CI) adjusted 1-sided (alpha = 2.05 %) of the difference between groups in terms of percentage of subjects. Confidence Interval (CI) for difference in proportion: Proc StatXact was used to derive the standardized asymptotic CI for the group difference in proportions \[Newcombe, 1998\]. The standardized asymptotic method used within GSK Biologicals is method 6.|Difference in percentage|-0.98|||||TWO_SIDED|95.9|-3.89|1.36||||||ANTI-1 serotype test: To demonstrate that 11Pn co-administered with Infanrix hexa™1 month post-dose 3 was non-inferior for at least 9 out of 11 serotypes to Prevnar13 (for 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of % of subjects with antibody concentrations ≥ 0.2 μg/mL. Criteria: UL of 2-sided 95.9 % CI of the difference between (Prevnar13 minus 11Pn) and (Synflorix minus 11Pn) groups \< 10 % for at least 9 out of 11 vaccine pneumococcal serotypes.||1.36|-3.89|
72439187|NCT01616459|144392349|NON_INFERIORITY_OR_EQUIVALENCE|2-sided 95.9% Confidence Interval (CI) adjusted 1-sided (alpha = 2.05 %) of the difference between groups in terms of percentage of subjects. Confidence Interval (CI) for difference in proportion: Proc StatXact was used to derive the standardized asymptotic CI for the group difference in proportions \[Newcombe, 1998\]. The standardized asymptotic method used within GSK Biologicals is method 6.|Difference in percentage|-1.08|||||TWO_SIDED|95.9|-4.94|2.45||||||ANTI-4 serotype test: To demonstrate that 11Pn co-administered with Infanrix hexa™1 month post-dose 3 was non-inferior for at least 9 out of 11 serotypes to Prevnar13 (for 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of % of subjects with antibody concentrations ≥ 0.2 μg/mL. Criteria: UL of 2-sided 95.9 % CI of the difference between (Prevnar13 minus 11Pn) and (Synflorix minus 11Pn) groups \< 10 % for at least 9 out of 11 vaccine pneumococcal serotypes.||2.45|-4.94|
72439188|NCT01616459|144392349|NON_INFERIORITY_OR_EQUIVALENCE|2-sided 95.9 % Confidence Interval (CI) adjusted 1-sided (alpha = 2.05 %) of the difference between groups in terms of percentage of subjects. Confidence Interval (CI) for difference in proportion: Proc StatXact was used to derive the standardized asymptotic CI for the group difference in proportions \[Newcombe, 1998\]. The standardized asymptotic method used within GSK Biologicals is method 6.|Difference in percentage|-0.48|||||TWO_SIDED|95.9|-2.82|1.38||||||ANTI-5 serotype test: To demonstrate that 11Pn co-administered with Infanrix hexa™1 month post-dose 3 was non-inferior for at least 9 out of 11 serotypes to Prevnar13 (for 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of % of subjects with antibody concentrations ≥ 0.2 μg/mL. Criteria: UL of 2-sided 95.9 % CI of the difference between (Prevnar13 minus 11Pn) and (Synflorix minus 11Pn) groups \< 10 % for at least 9 out of 11 vaccine pneumococcal serotypes.||1.38|-2.82|
72469436|NCT04750577|144462631|OTHER|MMRM estimates were used as input for the MCP-Mod. including the fixed, categorical effects of treatment at each visit (baseline, Week 6, Week 12 and Week 20), and the continuous effect of baseline at each visit as well as random effects of patient.||||||0.0294|||||||MCP-Mod linear model fit|Model assumption: No assumption was needed.||A flat vs. non-flat dose-response relationship across the 3 doses of BI 685509 and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, exponential, quadratic, Emax and Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.050). The total daily dose was considered for MCP-Mod analysis (placebo, active BI 685509 3 mg, 6 mg, and 9 mg).||||0.0294
72558808|NCT00474058|144647632|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.26|||<|0.0001||95.0|-6.08|-2.45||No p-value adjustment was necessary, since a multiple testing in a hierarchical sequentially rejective manner for the primary variable was applied.|ANCOVA|||Analyses of covariance were performed for the efficacy variables with treatment and (pooled) sites as factors, and baseline value as covariate. Least square means (LS means) for treatment effect were calculated and differences between rotigotine and placebo were presented with 95% confidence intervals (CIs) and p- values.||-2.45|-6.08|<0.0001
72495465|NCT01582308|144520139|SUPERIORITY_OR_OTHER||Least squares mean difference|62.86|||<|0.001|TWO_SIDED|90.0|58.21|67.74||P-value of between-treatment comparison of percent inhibition of DPP-4 activity.|Linear mixed effects model|||Analysis model included fixed effects terms for treatment and period.||67.74|58.21|<.001
72439189|NCT01616459|144392349|NON_INFERIORITY_OR_EQUIVALENCE|2-sided 95.9 % Confidence Interval (CI) adjusted 1-sided (alpha = 2.05 %) of the difference between groups in terms of percentage of subjects. Confidence Interval (CI) for difference in proportion: Proc StatXact was used to derive the standardized asymptotic CI for the group difference in proportions \[Newcombe, 1998\]. The standardized asymptotic method used within GSK Biologicals is method 6.|Difference in percentage|-2.24|||||TWO_SIDED|95.9|-10.65|6.13||||||ANTI-6B serotype test: To demonstrate that 11Pn co-administered with Infanrix hexa™1 month post-dose 3 was non-inferior for at least 9 out of 11 serotypes to Prevnar13 (for 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of % of subjects with antibody concentrations ≥ 0.2 μg/mL. Criteria: UL of 2-sided 95.9 % CI of the difference between (Prevnar13 minus 11Pn) and (Synflorix minus 11Pn) groups \< 10 % for at least 9 out of 11 vaccine pneumococcal serotypes.||6.13|-10.65|
72439190|NCT01616459|144392349|NON_INFERIORITY_OR_EQUIVALENCE|2-sided 95.9 % Confidence Interval (CI) adjusted 1-sided (alpha = 2.05 %) of the difference between groups in terms of percentage of subjects. Confidence Interval (CI) for difference in proportion: Proc StatXact was used to derive the standardized asymptotic CI for the group difference in proportions \[Newcombe, 1998\]. The standardized asymptotic method used within GSK Biologicals is method 6.|Difference in percentage|-0.03|||||TWO_SIDED|95.9|-2.39|2.21||||||ANTI-7F serotype test: To demonstrate that 11Pn co-administered with Infanrix hexa™1 month post-dose 3 was non-inferior for at least 9 out of 11 serotypes to Prevnar13 (for 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of % of subjects with antibody concentrations ≥ 0.2 μg/mL. Criteria: UL of 2-sided 95.9 % CI of the difference between (Prevnar13 minus 11Pn) and (Synflorix minus 11Pn) groups \< 10 % for at least 9 out of 11 vaccine pneumococcal serotypes.||2.21|-2.39|
72439191|NCT01616459|144392349|NON_INFERIORITY_OR_EQUIVALENCE|2-sided 95.9 % Confidence Interval (CI) adjusted 1-sided (alpha = 2.05 %) of the difference between groups in terms of percentage of subjects. Confidence Interval (CI) for difference in proportion: Proc StatXact was used to derive the standardized asymptotic CI for the group difference in proportions \[Newcombe, 1998\]. The standardized asymptotic method used within GSK Biologicals is method 6.|Difference in percentage|0.4|||||TWO_SIDED|95.9|-2.36|3.22||||||ANTI-9V serotype test: To demonstrate that 11Pn co-administered with Infanrix hexa™1 month post-dose 3 was non-inferior for at least 9 out of 11 serotypes to Prevnar13 (for 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of % of subjects with antibody concentrations ≥ 0.2 μg/mL. Criteria: UL of 2-sided 95.9 % CI of the difference between (Prevnar13 minus 11Pn) and (Synflorix minus 11Pn) groups \< 10 % for at least 9 out of 11 vaccine pneumococcal serotypes.||3.22|-2.36|
72439192|NCT01616459|144392349|NON_INFERIORITY_OR_EQUIVALENCE|2-sided 95.9 % Confidence Interval (CI) adjusted 1-sided (alpha = 2.05 %) of the difference between groups in terms of percentage of subjects. Confidence Interval (CI) for difference in proportion: Proc StatXact was used to derive the standardized asymptotic CI for the group difference in proportions \[Newcombe, 1998\]. The standardized asymptotic method used within GSK Biologicals is method 6.|Difference in percentage|0.45|||||TWO_SIDED|95.9|-1.51|2.66||||||ANTI-14 serotype test: To demonstrate that 11Pn co-administered with Infanrix hexa™1 month post-dose 3 was non-inferior for at least 9 out of 11 serotypes to Prevnar13 (for 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of % of subjects with antibody concentrations ≥ 0.2 μg/mL. Criteria: UL of 2-sided 95.9 % CI of the difference between (Prevnar13 minus 11Pn) and (Synflorix minus 11Pn) groups \< 10 % for at least 9 out of 11 vaccine pneumococcal serotypes.||2.66|-1.51|
72439193|NCT01616459|144392349|NON_INFERIORITY_OR_EQUIVALENCE|2-sided 95.9 % Confidence Interval (CI) adjusted 1-sided (alpha = 2.05 %) of the difference between groups in terms of percentage of subjects. Confidence Interval (CI) for difference in proportion: Proc StatXact was used to derive the standardized asymptotic CI for the group difference in proportions \[Newcombe, 1998\]. The standardized asymptotic method used within GSK Biologicals is method 6.|Difference in percentage|-1.0|||||TWO_SIDED|95.9|-4.18|1.7||||||ANTI-18C serotype test: To demonstrate that 11Pn co-administered with Infanrix hexa™1 month post-dose 3 was non-inferior for at least 9 out of 11 serotypes to Prevnar13 (for 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of % of subjects with antibody concentrations ≥ 0.2 μg/mL. Criteria: UL of 2-sided 95.9 % CI of the difference between (Prevnar13 minus 11Pn) and (Synflorix minus 11Pn) groups \< 10 % for at least 9 out of 11 vaccine pneumococcal serotypes.||1.70|-4.18|
72495466|NCT01582308|144520139|SUPERIORITY_OR_OTHER||Least squares mean difference|1.11||||0.128|TWO_SIDED|90.0|-0.1|2.33||P-value of between-treatment comparison of percent inhibition of DPP-4 activity.|Linear mixed effects model|||Analysis model included fixed effects terms for treatment and period.||2.33|-0.10|0.128
72495467|NCT01582308|144520139|SUPERIORITY_OR_OTHER||Least squares mean difference|88.24|||<|0.001|TWO_SIDED|90.0|85.77|90.76||P-value of between-treatment comparison of percent inhibition of DPP-4 activity.|Linear mixed effects model|||Analysis model included fixed effects terms for treatment and period.||90.76|85.77|<.001
72495468|NCT01582308|144520139|SUPERIORITY_OR_OTHER||Least squares mean difference|44.62|||<|0.001|TWO_SIDED|90.0|34.51|55.23||P-value of between-treatment comparison of percent inhibition of DPP-4 activity.|Linear mixed effects model|||Analysis model included fixed effects terms for treatment and period.||55.23|34.51|<.001
72495469|NCT01582308|144520139|SUPERIORITY_OR_OTHER||Least squares mean difference|-17.13|||<|0.001|TWO_SIDED|90.0|-21.21|-13.25||P-value of between-treatment comparison of percent inhibition of DPP-4 activity.|Linear mixed effects model|||Analysis model included fixed effects terms for treatment and period.||-13.25|-21.21|<.001
72495470|NCT01582308|144520139|SUPERIORITY_OR_OTHER||Least squares mean difference|70.0|||<|0.001|TWO_SIDED|90.0|58.46|82.2||P-value of between-treatment comparison of percent inhibition of DPP-4 activity.|Linear mixed effects model|||Analysis model included fixed effects terms for treatment and period.||82.20|58.46|<.001
72495471|NCT01582308|144520139|SUPERIORITY_OR_OTHER||Least squares mean difference|-61.75|||<|0.001|TWO_SIDED|90.0|-68.76|-55.18||P-value of between-treatment comparison of percent inhibition of DPP-4 activity.|Linear mixed effects model|||Analysis model included fixed effects terms for treatment and period.||-55.18|-68.76|<.001
72495472|NCT01582308|144520139|SUPERIORITY_OR_OTHER||Least squares mean difference|25.38|||<|0.001|TWO_SIDED|90.0|15.37|35.48||P-value of between-treatment comparison of percent inhibition of DPP-4 activity.|Linear mixed effects model|||Analysis model included fixed effects terms for treatment and period.||35.48|15.37|<.001
72439194|NCT01616459|144392349|NON_INFERIORITY_OR_EQUIVALENCE|2-sided 95.9 % Confidence Interval (CI) adjusted 1-sided (alpha = 2.05 %) of the difference between groups in terms of percentage of subjects. Confidence Interval (CI) for difference in proportion: Proc StatXact was used to derive the standardized asymptotic CI for the group difference in proportions \[Newcombe, 1998\]. The standardized asymptotic method used within GSK Biologicals is method 6.|Difference in percentage|-2.38|||||TWO_SIDED|95.9|-5.64|-0.52||||||ANTI-19F serotype test: To demonstrate that 11Pn co-administered with Infanrix hexa™1 month post-dose 3 was non-inferior for at least 9 out of 11 serotypes to Prevnar13 (for 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of % of subjects with antibody concentrations ≥ 0.2 μg/mL. Criteria: UL of 2-sided 95.9 % CI of the difference between (Prevnar13 minus 11Pn) and (Synflorix minus 11Pn) groups \< 10 % for at least 9 out of 11 vaccine pneumococcal serotypes.||-0.52|-5.64|
72439195|NCT01616459|144392349|NON_INFERIORITY_OR_EQUIVALENCE|2-sided 95.9 % Confidence Interval (CI) adjusted 1-sided (alpha = 2.05 %) of the difference between groups in terms of percentage of subjects. Confidence Interval (CI) for difference in proportion: Proc StatXact was used to derive the standardized asymptotic CI for the group difference in proportions \[Newcombe, 1998\]. The standardized asymptotic method used within GSK Biologicals is method 6.|Difference in percentage|2.73|||||TWO_SIDED|95.9|-4.84|10.25||||||ANTI-23F serotype test: To demonstrate that 11Pn co-administered with Infanrix hexa™1 month post-dose 3 was non-inferior for at least 9 out of 11 serotypes to Prevnar13 (for 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of % of subjects with antibody concentrations ≥ 0.2 μg/mL. Criteria: UL of 2-sided 95.9 % CI of the difference between (Prevnar13 minus 11Pn) and (Synflorix minus 11Pn) groups \< 10 % for at least 9 out of 11 vaccine pneumococcal serotypes.||10.25|-4.84|
72439196|NCT01616459|144392350|NON_INFERIORITY_OR_EQUIVALENCE|2-sided 95.9 % Confidence Interval (CI) adjusted 1-sided (alpha = 2.05 %) of the difference between groups in terms of percentage of subjects. Confidence Interval (CI) for difference in proportion: Proc StatXact was used to derive the standardized asymptotic CI for the group difference in proportions \[Newcombe, 1998\]. The standardized asymptotic method used within GSK Biologicals is method 6.|Difference in percentage|0.89|||||TWO_SIDED|95.9|-1.46|3.66||||||ANTI-19A serotype test: To demonstrate that 11Pn co-administered with Infanrix hexa™1 month post-dose 3 was non-inferior for at least 9 out of 11 serotypes to Prevnar13 (for 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of % of subjects with antibody concentrations ≥ 0.2 μg/mL. Criteria: UL of 2-sided 95.9 % CI of the difference between (Prevnar13 minus 11Pn) and (Synflorix minus 11Pn) groups \< 10 % for at least 9 out of 11 vaccine pneumococcal serotypes.||3.66|-1.46|
72439197|NCT01616459|144392351|NON_INFERIORITY_OR_EQUIVALENCE|Objectives for 12-valent formulation were to be assessed sequentially after demonstration of objectives for 11-valent formulation. 2-sided 95.8% Confidence Interval (CI) adjusted 1-sided (alpha =2.08%) of the difference between groups in terms of percentage of subjects. CI for difference in proportion: Proc StatXact was used to derive the standardized asymptotic CI for the group difference in proportions \[Newcombe,1998\]. The standardized asymptotic method used within GSK Biologicals is method 6.|Difference in percentage|-0.49|||||TWO_SIDED|95.8|-3.44|2.22||||||ANTI-1 serotype test: To demonstrate that 12Pn co-administered with Infanrix hexa™1 month post-dose 3 was non-inferior for at least 10 out of 12 serotypes to Prevnar13 (for 6A and 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of % of subjects with antibody concentrations ≥ 0.2 μg/mL. Criteria: UL of 2-sided 95.8 % CI of the difference between (Prevnar13 minus 12Pn) and (Synflorix minus 12Pn) groups \< 10 % for at least 10 out of 12 vaccine pneumococcal serotypes.||2.22|-3.44|
72439198|NCT01616459|144392351|NON_INFERIORITY_OR_EQUIVALENCE|Objectives for 12-valent formulation were to be assessed sequentially after demonstration of objectives for 11-valent formulation. 2-sided 95.8% Confidence Interval (CI) adjusted 1-sided (alpha =2.08%) of the difference between groups in terms of percentage of subjects. CI for difference in proportion: Proc StatXact was used to derive the standardized asymptotic CI for the group difference in proportions \[Newcombe,1998\]. The standardized asymptotic method used within GSK Biologicals is method 6.|Difference in percentage|-0.06|||||TWO_SIDED|95.8|-4.03|3.86||||||ANTI-4 serotype test: To demonstrate that 12Pn co-administered with Infanrix hexa™1 month post-dose 3 was non-inferior for at least 10 out of 12 serotypes to Prevnar13 (for 6A and 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of % of subjects with antibody concentrations ≥ 0.2 μg/mL. Criteria: UL of 2-sided 95.8 % CI of the difference between (Prevnar13 minus 12Pn) and (Synflorix minus 12Pn) groups \< 10 % for at least 10 out of 12 vaccine pneumococcal serotypes.||3.86|-4.03|
72495473|NCT01582308|144520139|SUPERIORITY_OR_OTHER||Least squares mean difference|87.13|||<|0.001|TWO_SIDED|90.0|80.06|94.61||P-value of between-treatment comparison of percent inhibition of DPP-4 activity.|Linear mixed effects model|||Analysis model included fixed effects terms for treatment and period.||94.61|80.06|<.001
72495474|NCT01227902|144520180|SUPERIORITY_OR_OTHER||percentage of participants|40.0|||||TWO_SIDED|95.0|27.1|52.9|||||The estimated value represents the percentage of participants with a \>=50% reduction in partial-onset seizure frequency from Baseline.|||52.9|27.1|
72495475|NCT01227902|144520180|SUPERIORITY_OR_OTHER||percentage of participants|32.0|||||TWO_SIDED|95.0|19.1|44.9|||||The estimated value represents the percentage of participants with a \>=50% reduction in partial-onset seizure frequency from Baseline.|||44.9|19.1|
72495476|NCT01227902|144520180|SUPERIORITY_OR_OTHER||percentage of participants|50.0|||||TWO_SIDED|95.0|35.2|64.8|||||The estimated value represents the percentage of participants with a \>=50% reduction in partial-onset seizure frequency from Baseline.|||64.8|35.2|
72495477|NCT01227902|144520180|SUPERIORITY_OR_OTHER||percentage of participants|56.9|||||TWO_SIDED|95.0|43.3|70.5|||||The estimated value represents the percentage of participants with a \>=50% reduction in partial-onset seizure frequency from Baseline.|||70.5|43.3|
72495478|NCT01227902|144520180|SUPERIORITY_OR_OTHER||percentage of participants|44.5|||||TWO_SIDED|95.0|37.6|51.4|||||The estimated value represents the percentage of participants with a \>=50% reduction in partial-onset seizure frequency from Baseline.|||51.4|37.6|
72618916|NCT01260324|144768306|SUPERIORITY_OR_OTHER_LEGACY||Incidence rate per 1000 person-years|0.99|||||TWO_SIDED|95.0|0.83|1.17|||||Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.|Incidence rate Visual disturbances||1.17|0.83|
72386597|NCT03572972|144281280|SUPERIORITY||Hazard Ratio (HR)|0.768|||||TWO_SIDED|95.0|0.684|0.862||||||Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.||0.862|0.684|
72386598|NCT03572972|144281280|SUPERIORITY||Hazard Ratio (HR)|0.875|||||TWO_SIDED|95.0|0.786|0.975||||||Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.||0.975|0.786|
72386599|NCT03572972|144281281|SUPERIORITY||Hazard Ratio (HR)|0.673|||||TWO_SIDED|95.0|0.47|0.964||||||Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.||0.964|0.470|
72386600|NCT03572972|144281281|SUPERIORITY||Hazard Ratio (HR)|0.491|||||TWO_SIDED|95.0|0.337|0.715||||||Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.||0.715|0.337|
72386601|NCT03572972|144281281|SUPERIORITY||Hazard Ratio (HR)|0.747|||||TWO_SIDED|95.0|0.548|1.018||||||Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.||1.018|0.548|
72386602|NCT03572972|144281282|SUPERIORITY||Hazard Ratio (HR)|1.463|||||TWO_SIDED|95.0|0.998|2.145||||||Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.||2.145|0.998|
72386603|NCT03572972|144281282|SUPERIORITY||Hazard Ratio (HR)|0.89|||||TWO_SIDED|95.0|0.647|1.225||||||Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.||1.225|0.647|
72386604|NCT03572972|144281282|SUPERIORITY||Hazard Ratio (HR)|0.63|||||TWO_SIDED|95.0|0.447|0.888||||||Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.||0.888|0.447|
72386605|NCT03572972|144281283|SUPERIORITY||Hazard Ratio (HR)|0.64|||||TWO_SIDED|95.0|0.556|0.738||||||Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.||0.738|0.556|
72386606|NCT03572972|144281283|SUPERIORITY||Hazard Ratio (HR)|0.624|||||TWO_SIDED|95.0|0.544|0.715||||||Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.||0.715|0.544|
72386607|NCT03572972|144281283|SUPERIORITY||Hazard Ratio (HR)|0.749|||||TWO_SIDED|95.0|0.588|0.954|||||HR evaluated using extended Cox model.|Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.||0.954|0.588|
72558809|NCT00474058|144647633|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.41||||0.0301||95.0|-0.79|-0.04|||ANCOVA|||Analyses of covariance were performed for the efficacy variables with treatment and (pooled) sites as factors, and baseline value as covariate. Least square means (LS means) for treatment effect were calculated and differences between rotigotine and placebo were presented with 95% confidence intervals (CIs) and p- values.||-0.04|-0.79|0.0301
72558810|NCT00474058|144647634|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02||||0.8842||95.0|-0.29|0.25|||ANCOVA|||Analyses of covariance were performed for the efficacy variables with treatment and (pooled) sites as factors, and baseline value as covariate. Least square means (LS means) for treatment effect were calculated and differences between rotigotine and placebo were presented with 95% confidence intervals (CIs) and p- values.||0.25|-0.29|0.8842
72558811|NCT03306277|144647655|SUPERIORITY||||||<|0.0001|||||||One-sided Exact Binomial Test|||This comparison is made to an assumed rate of zero 0 (or as low as 0.1%). By definition, children with spinal muscular atrophy Type 1 are never able to sit independently.||||<0.0001
72495479|NCT00930059|144520222|SUPERIORITY||LS mean difference|-0.31|STANDARD_ERROR_OF_MEAN|0.73||0.3353|TWO_SIDED|90.0|-1.52|0.9||The primary test of significance was 1-sided, and a nominal Type I error rate a = 0.05 was employed.|ANCOVA|||Least squares (LS) mean difference and p-values were based on analysis of covariance (ANCOVA) on change from baseline with treatment, baseline value, scheduled visit and visit by treatment interaction as covariates, and participant effect as random effect.||0.90|-1.52|0.3353
72386608|NCT03572972|144281284|SUPERIORITY||Hazard Ratio (HR)|0.977|||||TWO_SIDED|95.0|0.85|1.122||||||Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.||1.122|0.850|
72386609|NCT03572972|144281284|SUPERIORITY||Hazard Ratio (HR)|0.966|||||TWO_SIDED|95.0|0.848|1.1||||||Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.||1.100|0.848|
72386610|NCT03572972|144281284|SUPERIORITY||Hazard Ratio (HR)|0.993|||||TWO_SIDED|95.0|0.877|1.125||||||Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.||1.125|0.877|
72386611|NCT03572972|144281285|SUPERIORITY||Hazard Ratio (HR)|0.25|||||TWO_SIDED|95.0|0.119|0.523||||||Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.||0.523|0.119|
72386612|NCT03572972|144281285|SUPERIORITY||Hazard Ratio (HR)|0.38|||||TWO_SIDED|95.0|0.203|0.711||||||Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.||0.711|0.203|
72386613|NCT03572972|144281285|SUPERIORITY||Hazard Ratio (HR)|0.422|||||TWO_SIDED|95.0|0.247|0.722||||||Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.||0.722|0.247|
72386614|NCT03572972|144281286|SUPERIORITY||Hazard Ratio (HR)|0.745|||||TWO_SIDED|95.0|0.343|1.615||||||Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.||1.615|0.343|
72386615|NCT03572972|144281286|SUPERIORITY||Hazard Ratio (HR)|0.692|||||TWO_SIDED|95.0|0.342|1.402||||||Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.||1.402|0.342|
72386616|NCT03572972|144281286|SUPERIORITY||Hazard Ratio (HR)|0.932|||||TWO_SIDED|95.0|0.498|1.747||||||Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.||1.747|0.498|
72386617|NCT03572972|144281287|SUPERIORITY||Hazard Ratio (HR)|0.6|||||TWO_SIDED|95.0|0.492|0.731||||||Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.||0.731|0.492|
72386618|NCT03572972|144281287|SUPERIORITY||Hazard Ratio (HR)|1.046|||||TWO_SIDED|95.0|0.719|1.522|||||HR evaluated using extended Cox model.|Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.||1.522|0.719|
72386619|NCT03572972|144281287|SUPERIORITY||Hazard Ratio (HR)|1.295|||||TWO_SIDED|95.0|0.92|1.824|||||HR evaluated using extended Cox model.|Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.||1.824|0.920|
72386620|NCT03572972|144281288|SUPERIORITY||Hazard Ratio (HR)|0.751|||||TWO_SIDED|95.0|0.62|0.91||||||Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.||0.91|0.62|
72386621|NCT03572972|144281288|SUPERIORITY||Hazard Ratio (HR)|0.697|||||TWO_SIDED|95.0|0.586|0.83||||||Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.||0.830|0.586|
72386622|NCT03572972|144281288|SUPERIORITY||Hazard Ratio (HR)|0.936|||||TWO_SIDED|95.0|0.801|1.094||||||Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.||1.094|0.801|
72386623|NCT03572972|144281289|SUPERIORITY||Hazard Ratio (HR)|0.373|||||TWO_SIDED|95.0|0.212|0.658|||||HR evaluated using extended Cox model.|Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.||0.658|0.212|
72386624|NCT03572972|144281289|SUPERIORITY||Hazard Ratio (HR)|0.538|||||TWO_SIDED|95.0|0.392|0.737||||||Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.||0.737|0.392|
72386625|NCT03572972|144281289|SUPERIORITY||Hazard Ratio (HR)|0.664|||||TWO_SIDED|95.0|0.507|0.87||||||Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.||0.870|0.507|
72386626|NCT03572972|144281290|SUPERIORITY||Hazard Ratio (HR)|1.204|||||TWO_SIDED|95.0|0.871|1.666||||||Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.||1.666|0.871|
72386627|NCT03572972|144281290|SUPERIORITY||Hazard Ratio (HR)|0.918|||||TWO_SIDED|95.0|0.691|1.218||||||Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.||1.218|0.691|
72386628|NCT03572972|144281290|SUPERIORITY||Hazard Ratio (HR)|0.771|||||TWO_SIDED|95.0|0.578|1.027||||||Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.||1.027|0.578|
72386629|NCT03572972|144281291|SUPERIORITY||Hazard Ratio (HR)|0.581|||||TWO_SIDED|95.0|0.481|0.701||||||Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.||0.701|0.481|
72386630|NCT03572972|144281291|SUPERIORITY||Hazard Ratio (HR)|0.64|||||TWO_SIDED|95.0|0.534|0.766||||||Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.||0.766|0.534|
72386631|NCT03572972|144281291|SUPERIORITY||Hazard Ratio (HR)|0.838|||||TWO_SIDED|95.0|0.622|1.13|||||HR evaluated using extended Cox model.|Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.||1.130|0.622|
72386632|NCT03572972|144281292|SUPERIORITY||Hazard Ratio (HR)|0.881|||||TWO_SIDED|95.0|0.732|1.061||||||Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.||1.061|0.732|
72558812|NCT03306277|144647656|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||This comparison is made against the results from the age and gender-matched control participants selected from existing natural history data sets (PNCR) \[Neurol. 2014; 83(9):810-817\].|Data for the current study were compared to historical control data (Finkel et al,2014 - PubMed 25080519) where event-free survival was 6 out of 23 participants (26.1%) at 14 months of age.|||<0.0001
72386633|NCT03572972|144281292|SUPERIORITY||Hazard Ratio (HR)|0.802|||||TWO_SIDED|95.0|0.678|0.947||||||Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.||0.947|0.678|
72439199|NCT01616459|144392351|NON_INFERIORITY_OR_EQUIVALENCE|Objectives for 12-valent formulation were to be assessed sequentially after demonstration of objectives for 11-valent formulation. 2-sided 95.8% Confidence Interval (CI) adjusted 1-sided (alpha =2.08%) of the difference between groups in terms of percentage of subjects. CI for difference in proportion: Proc StatXact was used to derive the standardized asymptotic CI for the group difference in proportions \[Newcombe,1998\]. The standardized asymptotic method used within GSK Biologicals is method 6.|Difference in percentage|-0.01|||||TWO_SIDED|95.8|-2.37|2.3||||||ANTI-5 serotype test: To demonstrate that 12Pn co-administered with Infanrix hexa™1 month post-dose 3 was non-inferior for at least 10 out of 12 serotypes to Prevnar13 (for 6A and 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of % of subjects with antibody concentrations ≥ 0.2 μg/mL. Criteria: UL of 2-sided 95.8 % CI of the difference between (Prevnar13 minus 12Pn) and (Synflorix minus 12Pn) groups \< 10 % for at least 10 out of 12 vaccine pneumococcal serotypes.||2.30|-2.37|
72439200|NCT01616459|144392351|NON_INFERIORITY_OR_EQUIVALENCE|Objectives for 12-valent formulation were to be assessed sequentially after demonstration of objectives for 11-valent formulation. 2-sided 95.8% Confidence Interval (CI) adjusted 1-sided (alpha =2.08%) of the difference between groups in terms of percentage of subjects. CI for difference in proportion: Proc StatXact was used to derive the standardized asymptotic CI for the group difference in proportions \[Newcombe,1998\]. The standardized asymptotic method used within GSK Biologicals is method 6.|Difference in percentage|-4.67|||||TWO_SIDED|95.8|-12.94|3.6||||||ANTI-6B serotype test: To demonstrate that 12Pn co-administered with Infanrix hexa™1 month post-dose 3 was non-inferior for at least 10 out of 12 serotypes to Prevnar13 (for 6A and 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of % of subjects with antibody concentrations ≥ 0.2 μg/mL. Criteria: UL of 2-sided 95.8 % CI of the difference between (Prevnar13 minus 12Pn) and (Synflorix minus 12Pn) groups \< 10 % for at least 10 out of 12 vaccine pneumococcal serotypes.||3.60|-12.94|
72469437|NCT04750577|144462631|OTHER|A flat vs. non-flat dose-response relationship across the 3 doses of BI 685509 and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, exponential, quadratic, Emax and Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.050). The total daily dose was considered for MCP-Mod analysis (placebo, active BI 685509 3 mg, 6 mg, and 9 mg).||||||0.0468||||||MMRM estimates were used as input for the MCP-Mod. including the fixed, categorical effects of treatment at each visit (baseline, Week 6, Week 12 and Week 20), and the continuous effect of baseline at each visit as well as random effects of patient.|MCP-Mod quadratic model fit|Model assumption: 50 % of the maximum effect is achieved at a dose of 3 mg. 90 % of the maximum effect is achieved at a dose of 6 mg.||||||0.0468
72558813|NCT01296841|144647661|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0|||||t-test, 2 sided|We performed t-test statistics for univariate comparisons for continuous variables.||||||<0.05
72558814|NCT01852799|144647668|OTHER|||||||0.002|||||||Wilcoxon (Mann-Whitney)|||bALP changes from baseline to cycle 1||||0.002
72558815|NCT01852799|144647668|OTHER||||||<|0.001|||||||t-test, 2 sided|||b-ALP changes from baseline to cycle 4||||<0.001
72558816|NCT01852799|144647668|OTHER|||||||0.005|||||||Wilcoxon (Mann-Whitney)|||DKK-1 changes from baseline to cycle 1||||0.005
72386634|NCT03572972|144281292|SUPERIORITY||Hazard Ratio (HR)|0.882|||||TWO_SIDED|95.0|0.754|1.032||||||Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.||1.032|0.754|
72386635|NCT02569671|144281321|NON_INFERIORITY|"is less than the non-inferiority margin (indicating non-inferior bone gain).~The hypotheses associated with the primary analysis are defined as:~H0: µc - µs ≥ δ H1: µc - µs \< δ where µc is the mean change in crestal bone levels from implant loading to 12 months post-implant loading for the treatment group, µs is the mean change for the control group, and δ is the 0.5 mm non-inferiority margin. The hypotheses will be tested using a one-sided t-test with a 5% significance level."|Mean Difference (Final Values)|0.5|STANDARD_DEVIATION|0.5||0.95|ONE_SIDED|95.0||||SD for both test and control group is 0.5 mm, A difference between groups of ≥ 0.5 mm is considered clinically significant, The difference between the treatment groups is expected to be 0 mm, Statistical test will be one-sided 5% significance level.|t-test, 1 sided|The hypotheses will be tested using a one-sided t-test with a 5% significance level.|The hypotheses will be tested using a one-sided t-test with a 5% significance level.|The null hypothesis for the primary analysis is that the difference between the mean change in crestal bone levels for the treatment and control groups is at least the non-inferiority margin (indicating inferior bone gain). Rejection of the null hypothesis indicates the observed data supports the alternative hypothesis that the difference between the mean change in crestal bone levels for the treatment and control groups|The change in mean bone level from implant loading to 12-month follow-up was calculated. Change in crestal bone levels was calculated as the crestal bone level at 12-months post implant loading minus crestal bone level at implant loading.|||.950
72386636|NCT02569671|144281323|NON_INFERIORITY|Smaller bone dimensional thickness of the buccal plate measurements indicates less bone loss and better healing.|Mean Difference (Final Values)|0.1|STANDARD_DEVIATION|0.3||0.022|ONE_SIDED|95.0|||||t-test, 1 sided|The hypotheses will be tested using a one-sided t-test with a 5% significance level.||All secondary effectiveness endpoints were planned to be summarized descriptively, and no hypothesis tests was planned.||||0.022
72558817|NCT01852799|144647668|OTHER||||||<|0.001|||||||t-test, 2 sided|||DKK-1 changes from baseline to cycle 4||||<0.001
72439201|NCT01616459|144392351|NON_INFERIORITY_OR_EQUIVALENCE|Objectives for 12-valent formulation were to be assessed sequentially after demonstration of objectives for 11-valent formulation. 2-sided 95.8% Confidence Interval (CI) adjusted 1-sided (alpha =2.08%) of the difference between groups in terms of percentage of subjects. CI for difference in proportion: Proc StatXact was used to derive the standardized asymptotic CI for the group difference in proportions \[Newcombe,1998\]. The standardized asymptotic method used within GSK Biologicals is method 6.|Difference in percentage|0.46|||||TWO_SIDED|95.8|-1.93|3.06||||||ANTI-7F serotype test: To demonstrate that 12Pn co-administered with Infanrix hexa™1 month post-dose 3 was non-inferior for at least 10 out of 12 serotypes to Prevnar13 (for 6A and 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of % of subjects with antibody concentrations ≥ 0.2 μg/mL. Criteria: UL of 2-sided 95.8 % CI of the difference between (Prevnar13 minus 12Pn) and (Synflorix minus 12Pn) groups \< 10 % for at least 10 out of 12 vaccine pneumococcal serotypes.||3.06|-1.93|
72439202|NCT01616459|144392351|NON_INFERIORITY_OR_EQUIVALENCE|Objectives for 12-valent formulation were to be assessed sequentially after demonstration of objectives for 11-valent formulation. 2-sided 95.8% Confidence Interval (CI) adjusted 1-sided (alpha =2.08%) of the difference between groups in terms of percentage of subjects. CI for difference in proportion: Proc StatXact was used to derive the standardized asymptotic CI for the group difference in proportions \[Newcombe,1998\]. The standardized asymptotic method used within GSK Biologicals is method 6.|Difference in percentage|-0.02|||||TWO_SIDED|95.8|-2.72|2.64||||||ANTI-9V serotype test: To demonstrate that 12Pn co-administered with Infanrix hexa™1 month post-dose 3 was non-inferior for at least 10 out of 12 serotypes to Prevnar13 (for 6A and 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of % of subjects with antibody concentrations ≥ 0.2 μg/mL. Criteria: UL of 2-sided 95.8 % CI of the difference between (Prevnar13 minus 12Pn) and (Synflorix minus 12Pn) groups \< 10 % for at least 10 out of 12 vaccine pneumococcal serotypes.||2.64|-2.72|
72439203|NCT01616459|144392351|NON_INFERIORITY_OR_EQUIVALENCE|Objectives for 12-valent formulation were to be assessed sequentially after demonstration of objectives for 11-valent formulation. 2-sided 95.8% Confidence Interval (CI) adjusted 1-sided (alpha =2.08%) of the difference between groups in terms of percentage of subjects. CI for difference in proportion: Proc StatXact was used to derive the standardized asymptotic CI for the group difference in proportions \[Newcombe,1998\]. The standardized asymptotic method used within GSK Biologicals is method 6.|Difference in percentage|0.0|||||TWO_SIDED|95.8|-1.94|1.9||||||ANTI-14 serotype test: To demonstrate that 12Pn co-administered with Infanrix hexa™1 month post-dose 3 was non-inferior for at least 10 out of 12 serotypes to Prevnar13 (for 6A and 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of % of subjects with antibody concentrations ≥ 0.2 μg/mL. Criteria: UL of 2-sided 95.8 % CI of the difference between (Prevnar13 minus 12Pn) and (Synflorix minus 12Pn) groups \< 10 % for at least 10 out of 12 vaccine pneumococcal serotypes.||1.90|-1.94|
72439204|NCT01616459|144392351|NON_INFERIORITY_OR_EQUIVALENCE|Objectives for 12-valent formulation were to be assessed sequentially after demonstration of objectives for 11-valent formulation. 2-sided 95.8% Confidence Interval (CI) adjusted 1-sided (alpha =2.08%) of the difference between groups in terms of percentage of subjects. CI for difference in proportion: Proc StatXact was used to derive the standardized asymptotic CI for the group difference in proportions \[Newcombe,1998\]. The standardized asymptotic method used within GSK Biologicals is method 6.|Difference in percentage|-0.5|||||TWO_SIDED|95.8|-3.72|2.52||||||ANTI-18C serotype test: To demonstrate that 12Pn co-administered with Infanrix hexa™1 month post-dose 3 was non-inferior for at least 10 out of 12 serotypes to Prevnar13 (for 6A and 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of % of subjects with antibody concentrations ≥ 0.2 μg/mL. Criteria: UL of 2-sided 95.8 % CI of the difference between (Prevnar13 minus 12Pn) and (Synflorix minus 12Pn) groups \< 10 % for at least 10 out of 12 vaccine pneumococcal serotypes.||2.52|-3.72|
72439205|NCT01616459|144392351|NON_INFERIORITY_OR_EQUIVALENCE|Objectives for 12-valent formulation were to be assessed sequentially after demonstration of objectives for 11-valent formulation. 2-sided 95.8% Confidence Interval (CI) adjusted 1-sided (alpha =2.08%) of the difference between groups in terms of percentage of subjects. CI for difference in proportion: Proc StatXact was used to derive the standardized asymptotic CI for the group difference in proportions \[Newcombe,1998\]. The standardized asymptotic method used within GSK Biologicals is method 6.|Difference in percentage|-0.98|||||TWO_SIDED|95.8|-4.38|2.1||||||ANTI-19F serotype test: To demonstrate that 12Pn co-administered with Infanrix hexa™1 month post-dose 3 was non-inferior for at least 10 out of 12 serotypes to Prevnar13 (for 6A and 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of % of subjects with antibody concentrations ≥ 0.2 μg/mL. Criteria: UL of 2-sided 95.8 % CI of the difference between (Prevnar13 minus 12Pn) and (Synflorix minus 12Pn) groups \< 10 % for at least 10 out of 12 vaccine pneumococcal serotypes.||2.10|-4.38|
72558818|NCT00672984|144647710|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.43||||||90.0|-4.52|-0.34||||||||-0.34|-4.52|
72558819|NCT00672984|144647710|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|13.87||||||90.0|11.45|16.29||||||||16.29|11.45|
72558820|NCT00672984|144647711|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-8.08||||||90.0|-11.37|-4.78||||||||-4.78|-11.37|
72558821|NCT00672984|144647711|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|13.13||||||90.0|9.33|16.93||||||||16.93|9.33|
72558822|NCT00672984|144647712|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.98||||||90.0|-1.07|3.03||||||||3.03|-1.07|
72558823|NCT00672984|144647712|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|11.11||||||90.0|8.97|13.24||||||||13.24|8.97|
72558824|NCT00672984|144647713|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.64||||||90.0|-0.99|4.27||||||||4.27|-0.99|
72558825|NCT00672984|144647713|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|10.8||||||90.0|7.63|13.97||||||||13.97|7.63|
72558826|NCT00672984|144647714|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.76||||||90.0|-8.01|-5.51||||||||-5.51|-8.01|
72558827|NCT00672984|144647714|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.73||||||90.0|3.08|6.38||||||||6.38|3.08|
72558828|NCT00672984|144647715|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-19.85||||||90.0|-21.92|-17.78||||||||-17.78|-21.92|
72558829|NCT00672984|144647715|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.44||||||90.0|1.77|5.11||||||||5.11|1.77|
72558830|NCT00672984|144647716|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|15.32||||||90.0|11.75|18.89||||||||18.89|11.75|
72558831|NCT00672984|144647716|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.93||||||90.0|-2.77|4.63||||||||4.63|-2.77|
72558832|NCT00672984|144647717|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|49.85||||||90.0|44.71|54.98||||||||54.98|44.71|
72386637|NCT02612129|144281330|SUPERIORITY||Least Square (LS) Mean Difference|-1.4||||0.0456|TWO_SIDED|95.0|-2.76|-0.03|||GLMM for Repeated Measures|||A general linear mixed model (GLMM) for repeated measurements was used for the analysis of NPC disease severity assessed based on the 5-domain NPCCSS scores at Month 12. The general linear mixed model analysis for repeated measures was fitted with treatment, miglustat level and visit as fixed effects including treatment-by-visit interaction and baseline score as a covariate.||-0.03|-2.76|0.0456
72386638|NCT02612129|144281331|SUPERIORITY|||||||1|||||||Chi-squared Test|||||||1.0000
72386639|NCT02612129|144281332|SUPERIORITY|||||||0.5456|||||||Chi-squared Test|||||||0.5456
72386640|NCT02612129|144281333|SUPERIORITY|||||||0.8021|||||||Log-Rank Test|||Log-rank test had been stratified by miglustat use.||||0.8021
72386641|NCT02612129|144281334|SUPERIORITY|||||||0.3662|||||||Fisher's Exact Test|||Percentage of participants worsening at Month 6||||0.3662
72386642|NCT02612129|144281334|SUPERIORITY|||||||1|||||||Fisher's Exact Test|||Percentage of participants worsening at Month 12||||1.0000
72386643|NCT02612129|144281335|SUPERIORITY||LS Mean Difference|-1.69||||0.1546|TWO_SIDED|95.0|-4.04|0.66|||ANCOVA|||Change From Baseline in 17-Domain NPCCSS Apart from Hearing Domains (i.e. Hearing and Auditory Brainstem Response) at Month 6 was analyzed using the Analysis of covariance (ANCOVA) model. ANCOVA model was fitted with treatment, baseline full-scale NPCCSS apart from hearing domains score, and use of miglustat as covariates.||0.66|-4.04|0.1546
72386644|NCT02612129|144281335|SUPERIORITY||LS Mean Difference|-1.61||||0.2199|TWO_SIDED|95.0|-4.24|1.01|||ANCOVA|||Change From Baseline in 17-Domain NPCCSS Apart from Hearing Domains (i.e. Hearing and Auditory Brainstem Response) at Month 12 was analyzed using the ANCOVA model. ANCOVA model is fitted with treatment, baseline full-scale NPCCSS apart from hearing domains score, and use of miglustat as covariates.||1.01|-4.24|0.2199
72386645|NCT02612129|144281336|SUPERIORITY||Least Square (LS) Mean Difference|-1.11||||0.0188|TWO_SIDED|95.0|-2.03|-0.19|||ANCOVA|||An ANCOVA model was fitted with treatment, baseline 5-domain NPCCSS score, and use of miglustat as covariates.||-0.19|-2.03|0.0188
72386646|NCT02612129|144281338|SUPERIORITY||LS Mean Difference|-5.09||||0.0536|TWO_SIDED|95.0|-10.26|0.08|||ANCOVA|||"Change from baseline in the NPC-CDB score (modified Stampfer Score) at Month 6 was analyzed using the ANCOVA model. ANCOVA model was fitted with treatment, baseline NPC-CDB total score and use of miglustat as covariates."||0.08|-10.26|0.0536
72386647|NCT02612129|144281338|SUPERIORITY||LS Mean Difference|-3.03||||0.3785|TWO_SIDED|95.0|-9.9|3.85|||ANCOVA|||"Change from baseline in the NPC-CDB score (modified Stampfer Score) at Month 12 was analyzed using the ANCOVA model. ANCOVA model was fitted with treatment, baseline NPC-CDB total score and use of miglustat as covariates."||3.85|-9.90|0.3785
72386648|NCT02612129|144281339|SUPERIORITY|||||||0.6951|||||||Chi-squared Test|||Percentage of participants with change from baseline at Month 6 in Quality of Life (EQ-5D-Y) being 'Better'||||0.6951
72439206|NCT01616459|144392351|NON_INFERIORITY_OR_EQUIVALENCE|Objectives for 12-valent formulation were to be assessed sequentially after demonstration of objectives for 11-valent formulation. 2-sided 95.8% Confidence Interval (CI) adjusted 1-sided (alpha =2.08%) of the difference between groups in terms of percentage of subjects. CI for difference in proportion: Proc StatXact was used to derive the standardized asymptotic CI for the group difference in proportions \[Newcombe,1998\]. The standardized asymptotic method used within GSK Biologicals is method 6.|Difference in percentage|2.5|||||TWO_SIDED|95.8|-5.07|10.06||||||ANTI-23F serotype test: To demonstrate that 12Pn co-administered with Infanrix hexa™1 month post-dose 3 was non-inferior for at least 10 out of 12 serotypes to Prevnar13 (for 6A and 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of % of subjects with antibody concentrations ≥ 0.2 μg/mL. Criteria: UL of 2-sided 95.8 % CI of the difference between (Prevnar13 minus 12Pn) and (Synflorix minus 12Pn) groups \< 10 % for at least 10 out of 12 vaccine pneumococcal serotypes.||10.06|-5.07|
72386649|NCT02612129|144281339|SUPERIORITY|||||||0.7542|||||||Chi-squared Test|||Percentage of participants with change from baseline at Month 6 in Quality of Life (EQ-5D-Y) being 'Worse'||||0.7542
72386650|NCT02612129|144281339|SUPERIORITY|||||||0.488|||||||Chi-squared Test|||Percentage of participants with change from baseline at Month 12 in Quality of Life (EQ-5D-Y) being 'Better'||||0.4880
72386651|NCT02612129|144281339|SUPERIORITY|||||||0.1804|||||||Chi-squared Test|||Percentage of participants with change from baseline at Month 12 in Quality of Life (EQ-5D-Y) being 'Worse'||||0.1804
72558833|NCT00672984|144647717|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.63||||||90.0|-0.41|7.66||||||||7.66|-0.41|
72558834|NCT00985751|144647746|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The 95% CI for the difference between groups in the percentage of subjects with rectal temperature \> 40.0°C within the 7-day follow-up period following primary vaccination was computed for the Synflorix/GSK 2189242A Group minus Synflorix Group. No statistically significant difference between groups in rectal temperature \>40.0°C would be detected if the 95% CIs included 0 and non-inferiority would|Difference in percentage|0.97|||||TWO_SIDED|95.0|-6.1|5.32||||||Fever \>40°C-non-inferiority: To compare the 2 formulations of GSK Biologicals' S. pneumoniae protein containing vaccine (GSK 2189242A) combined with Synflorix™ vaccine (pooled groups) versus Synflorix™ vaccine (Synflorix/GSK 2189242A Group minus Synflorix Group) with respect to the percentage of subjects reporting fever \> 40.0°C (rectal temperature) within 7 days after at least 1 dose of primary vaccination.||5.32|-6.1|
72618917|NCT01260324|144768306|SUPERIORITY_OR_OTHER_LEGACY||Incidence rate per 1000 person-years|2.0|||||TWO_SIDED|95.0|1.6|2.46|||||Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.|Incidence rate Blindness and low vision||2.46|1.60|
72386652|NCT02612129|144281340|SUPERIORITY||LS Mean Difference|0.74||||0.371|TWO_SIDED|95.0|-0.92|2.4|||ANCOVA|||Change from baseline in the SARA score at Month 6 was measured using an ANCOVA model. ANCOVA model was fitted with treatment, baseline SARA score, and use of miglustat as covariates.||2.40|-0.92|0.3710
72386653|NCT02612129|144281340|SUPERIORITY||LS Mean Difference|0.28||||0.7899|TWO_SIDED|95.0|-1.82|2.37|||ANCOVA|||Change from baseline in the SARA score at Month 12 was measured using an ANCOVA model. ANCOVA model was fitted with treatment, baseline SARA score and use of miglustat as covariates.||2.37|-1.82|0.7899
72558835|NCT00985751|144647747|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The 95% CI for the difference between groups in the percentage of subjects with rectal temperature \> 40.0°C within the 7-day follow-up period following primary vaccination was computed for the GSK 2189242A Group minus Synflorix Group. No statistically significant difference between groups in rectal temperature \>40.0°C would be detected if the 95% CIs included 0 and non-inferiority would be express|Difference in percentage|0.97|||||TWO_SIDED|95.0|-6.1|5.32||||||Fever \>40°C-non-inferiority: To compare the 2 formulations of GSK Biologicals' S. pneumoniae protein containing vaccine GSK 2189242A (pooled groups) versus Synflorix™ vaccine (GSK 2189242A Group minus Synflorix Group) with respect to the percentage of subjects reporting fever \> 40.0°C (rectal temperature) within 7 days after at least 1 dose of primary vaccination.||5.32|-6.1|
72618918|NCT01260324|144768306|SUPERIORITY_OR_OTHER_LEGACY||Incidence rate per 1000 person-years|0.19|||||TWO_SIDED|95.0|0.16|0.23|||||Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.|Incidence rate Other disorders of eye||0.23|0.16|
72618919|NCT01260324|144768306|SUPERIORITY_OR_OTHER_LEGACY||Incidence rate per 1000 person-years|0.22|||||TWO_SIDED|95.0|0.18|0.27|||||Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.|Incidence rate Occlusion and stenosis of precerebral arteries||0.27|0.18|
72618920|NCT01260324|144768306|SUPERIORITY_OR_OTHER_LEGACY||Incidence rate per 1000 person-years|0.07|||||TWO_SIDED|95.0|0.05|0.08|||||Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.|Incidence rate Acute sinusitis||0.08|0.05|
72618921|NCT01260324|144768306|SUPERIORITY_OR_OTHER_LEGACY||Incidence rate per 1000 person-years|0.06|||||TWO_SIDED|95.0|0.05|0.08|||||Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.|Incidence rate Other dermatoses||0.08|0.05|
72386654|NCT02612129|144281341|SUPERIORITY||LS Mean Difference|-10.34||||0.6195|TWO_SIDED|95.0|-53.01|32.33|||ANCOVA|||Dominant Hand: Change From Baseline in the Nine-Hole Peg Test (9HPT) at Month 6 was measured using an ANCOVA model: ANCOVA models were fitted with treatment, baseline dominant/non-dominant hand 9HPT time (secs), and use of miglustat as covariates||32.33|-53.01|0.6195
72386655|NCT02612129|144281341|SUPERIORITY||LS Mean Difference|-15.87||||0.4693|TWO_SIDED|95.0|-60.73|29.0|||ANCOVA|||Non-dominant Hand: Change From Baseline in the Nine-Hole Peg Test (9HPT) at Month 6 was measured using an ANCOVA model: ANCOVA models were fitted with treatment, baseline dominant/non-dominant hand 9HPT time (secs), and use of miglustat as covariates||29.00|-60.73|0.4693
72386656|NCT02612129|144281341|SUPERIORITY||LS Mean Difference|3.2||||0.7283|TWO_SIDED|95.0|-15.71|22.12|||ANCOVA|||Dominant Hand: Change From Baseline in the Nine-Hole Peg Test (9HPT) at Month 12 was measured using an ANCOVA model: ANCOVA models were fitted with treatment, baseline dominant/non-dominant hand 9HPT time (secs), and use of miglustat as covariates||22.12|-15.71|0.7283
72386657|NCT02612129|144281341|SUPERIORITY||LS Mean Difference|-5.91||||0.7708|TWO_SIDED|95.0|-47.54|35.72|||ANCOVA|||Non-dominant Hand: Change From Baseline in the Nine-Hole Peg Test (9HPT) at Month 12 was measured using an ANCOVA model: ANCOVA models were fitted with treatment, baseline dominant/non-dominant hand 9HPT time (secs), and use of miglustat as covariates||35.72|-47.54|0.7708
72386658|NCT00531934|144281376|SUPERIORITY_OR_OTHER|||||||0.175|||||||Chi-squared|||||||0.175
72386659|NCT00531934|144281379|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||Erlotinib + doxycycline vs Erlotinib: Grade 3 intensity skin rash (folliculitis)||||<0.001
72386660|NCT00531934|144281385|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.763||||0.143|TWO_SIDED|95.0|0.525|1.109|||Log Rank|||||1.109|0.525|0.143
72386661|NCT00531934|144281388|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.769||||0.153|TWO_SIDED|95.0|0.529|1.116|||Log Rank|||||1.116|0.529|0.153
72386662|NCT00531934|144281394|SUPERIORITY_OR_OTHER|||||||0.003|||||||Cochran-Mantel-Haenszel|||Erlotinib + doxycycline vs Erlotinib: Grade 3||||0.003
72386663|NCT02975336|144281524|SUPERIORITY||Odds Ratio (OR)|1.55||||0.5462|TWO_SIDED|95.0|0.91|2.64|||Regression, Logistic|||||2.64|0.91|0.5462
72386664|NCT02975336|144281524|SUPERIORITY||Odds Ratio (OR)|1.29||||0.5462|TWO_SIDED|95.0|0.76|2.18|||Regression, Logistic|||||2.18|0.76|0.5462
72386665|NCT02975336|144281524|SUPERIORITY||Odds Ratio (OR)|1.13||||0.5462|TWO_SIDED|95.0|0.67|1.93|||Regression, Logistic|||||1.93|0.67|0.5462
72386666|NCT02975336|144281525|SUPERIORITY||Odds Ratio (OR)|1.5||||0.5462|TWO_SIDED|95.0|0.69|3.24|||Regression, Logistic|||||3.24|0.69|0.5462
72386667|NCT02975336|144281525|SUPERIORITY||Odds Ratio (OR)|1.42||||0.5462|TWO_SIDED|95.0|0.68|2.97|||Regression, Logistic|||||2.97|0.68|0.5462
72386668|NCT02975336|144281525|SUPERIORITY||Odds Ratio (OR)|1.27||||0.5462|TWO_SIDED|95.0|0.59|2.75|||Regression, Logistic|||||2.75|0.59|0.5462
72386669|NCT02975336|144281553|SUPERIORITY||Hazard Ratio (HR)|1.17||||0.7034|TWO_SIDED|95.0|0.57|2.4|||Cox proportional hazards model|||||2.40|0.57|0.7034
72386670|NCT02975336|144281553|SUPERIORITY||Hazard Ratio (HR)|0.69||||0.5462|TWO_SIDED|95.0|0.31|1.52|||Cox proportional hazards model|||||1.52|0.31|0.5462
72386671|NCT02975336|144281553|SUPERIORITY||Hazard Ratio (HR)|0.9||||0.5462|TWO_SIDED|95.0|0.42|1.97|||Cox proportional hazards model|||||1.97|0.42|0.5462
72386672|NCT02975336|144281554|SUPERIORITY||Odds Ratio (OR)|1.52||||0.5462|TWO_SIDED|95.0|0.74|3.15|||Regression, Logistic|||||3.15|0.74|0.5462
72386673|NCT02975336|144281554|SUPERIORITY||Odds Ratio (OR)|1.03||||0.5462|TWO_SIDED|95.0|0.49|2.13|||Regression, Logistic|||||2.13|0.49|0.5462
72386674|NCT02975336|144281554|SUPERIORITY||Odds Ratio (OR)|1.35||||0.5462|TWO_SIDED|95.0|0.65|2.81|||Regression, Logistic|||||2.81|0.65|0.5462
72386675|NCT02975336|144281555|SUPERIORITY||Odds Ratio (OR)|1.6||||0.2434|TWO_SIDED|95.0|0.73|3.54|||Regression, Logistic|||||3.54|0.73|0.2434
72386676|NCT02975336|144281555|SUPERIORITY||Odds Ratio (OR)|1.62||||0.2389|TWO_SIDED|95.0|0.73|3.63|||Regression, Logistic|||||3.63|0.73|0.2389
72386677|NCT02975336|144281555|SUPERIORITY||Odds Ratio (OR)|1.71||||0.1952|TWO_SIDED|95.0|0.76|3.85|||Regression, Logistic|||||3.85|0.76|0.1952
72386678|NCT02975336|144281556|SUPERIORITY||Hazard Ratio (HR)|1.59||||0.0987|TWO_SIDED|95.0|0.87|2.89|||Cox proportional hazards model|||||2.89|0.87|0.0987
72386679|NCT02975336|144281556|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.9201|TWO_SIDED|95.0|0.51|1.85|||Cox proportional hazards model|||||1.85|0.51|0.9201
72439207|NCT01616459|144392352|NON_INFERIORITY_OR_EQUIVALENCE|Objectives for 12-valent formulation were to be assessed sequentially after demonstration of objectives for 11-valent formulation. 2-sided 95.8% Confidence Interval (CI) adjusted 1-sided (alpha =2.08%) of the difference between groups in terms of percentage of subjects. CI for difference in proportion: Proc StatXact was used to derive the standardized asymptotic CI for the group difference in proportions \[Newcombe,1998\]. The standardized asymptotic method used within GSK Biologicals is method 6.|Difference in percentage|11.22|||||TWO_SIDED|95.8|7.22|16.49||||||ANTI-6A serotype test: To demonstrate that 12Pn co-administered with Infanrix hexa™1 month post-dose 3 was non-inferior for at least 10 out of 12 serotypes to Prevnar13 (for 6A \& 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of % of subjects with antibody concentrations ≥ 0.2 μg/mL. Criteria: UL of 2-sided 95.8 % CI of the difference between (Prevnar13 minus 12Pn) and (Synflorix minus 12Pn) groups \<10% for at least 10 out of 12 vaccine pneumococcal serotypes.||16.49|7.22|
72439208|NCT01616459|144392352|NON_INFERIORITY_OR_EQUIVALENCE|Objectives for 12-valent formulation were to be assessed sequentially after demonstration of objectives for 11-valent formulation. 2-sided 95.8% Confidence Interval (CI) adjusted 1-sided (alpha =2.08%) of the difference between groups in terms of percentage of subjects. CI for difference in proportion: Proc StatXact was used to derive the standardized asymptotic CI for the group difference in proportions \[Newcombe,1998\]. The standardized asymptotic method used within GSK Biologicals is method 6.|Difference in percentage|3.75|||||TWO_SIDED|95.8|1.03|7.57||||||ANTI-19A serotype test: To demonstrate that 12Pn co-administered with Infanrix hexa™1 month post-dose 3 was non-inferior for at least 10 out of 12 serotypes to Prevnar13 (for 6A \& 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of % of subjects with antibody concentrations ≥ 0.2 μg/mL. Criteria: UL of 2-sided 95.8 % CI of the difference between (Prevnar13 minus 12Pn) and (Synflorix minus 12Pn) groups \<10% for at least 10 out of 12 vaccine pneumococcal serotypes.||7.57|1.03|
72439209|NCT01622868|144392392|SUPERIORITY|||||||0.97||||||One-sided significance level = 0.10|Z-test|||The study was designed to see if there is a signal in the 12-week CR rate with the addition of lapatinib to warrant a future phase III trial. Null hypothesis: the 12-week post-WBRT/SRS CR rate is ≤ 5%; alternative hypothesis: the addition of lapatinib will increase that CR rate to at least 20%. 114 eligible participants provide 86% power to detect a 15% absolute increase in CR rate at a significance level of 0.10, using a 1-sided Z-test for the difference of 2 proportions.||||0.97
72439210|NCT01622868|144392393|SUPERIORITY|||||||0.78||||||One-sided significance level = 0.10|Z-test|||||||0.78
72439211|NCT01622868|144392394|SUPERIORITY|||||||0.78||||||One-sided significance level = 0.10|Z-test|||4 weeks post-RT||||0.78
72439212|NCT01622868|144392394|SUPERIORITY|||||||0.97||||||One-sided significance level = 0.10|Z-test|||12 weeks post-RT||||0.97
72439213|NCT01622868|144392400|SUPERIORITY|||||||1||||||One-sided significance level = 0.10|z-test|||||||1.00
72439214|NCT01622868|144392402|SUPERIORITY||Hazard Ratio (HR)|0.92||||0.67|TWO_SIDED|95.0|0.62|1.36||Two-sided significance level = 0.05|Log Rank|||||1.36|0.62|0.67
72439215|NCT04425629|144392406|SUPERIORITY||LS Mean|-0.33|STANDARD_ERROR_OF_MEAN|0.1|=|0.0006|TWO_SIDED|95.0|-0.52|-0.14|||ANCOVA|||||-0.14|-0.52|= 0.0006
72618922|NCT01260324|144768306|SUPERIORITY_OR_OTHER_LEGACY||Incidence rate per 1000 person-years|0.08|||||TWO_SIDED|95.0|0.06|0.1|||||Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.|Incidence rate Other disorders of bone and cartilage||0.10|0.06|
72439216|NCT04425629|144392406|SUPERIORITY||LS Mean|-0.37|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001|TWO_SIDED|95.0|-0.56|-0.19|||ANCOVA|||||-0.19|-0.56|< 0.0001
72439217|NCT04425629|144392407|SUPERIORITY||||||=|0.0024|||||||Cochran-Mantel-Haenszel|||||||= 0.0024
72439218|NCT04425629|144392408|SUPERIORITY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||< 0.0001
72439219|NCT04425629|144392414|SUPERIORITY||||||=|0.1903|||||||Mixed Models Analysis|||||||= 0.1903
72439220|NCT04425629|144392414|SUPERIORITY||||||=|0.8431|||||||Mixed Models Analysis|||||||= 0.8431
72439221|NCT04425629|144392470|SUPERIORITY||Hazard Ratio (HR)|1.01|||||TWO_SIDED|95.0|0.06|16.12||||||||16.12|0.06|
72495480|NCT00930059|144520223|SUPERIORITY||LS mean difference|0.2|STANDARD_ERROR_OF_MEAN|0.72||0.6073|TWO_SIDED|90.0|-0.99|1.38||No adjustments made for multiple comparisons.|ANCOVA|||Change at Week 3: LS mean difference and p-values were based on ANCOVA on change from baseline with treatment, baseline value, scheduled visit and visit by treatment interaction as covariates, and participant effect as random effect.||1.38|-0.99|0.6073
72618923|NCT01260324|144768306|SUPERIORITY_OR_OTHER_LEGACY||Incidence rate per 1000 person-years|0.12|||||TWO_SIDED|95.0|0.1|0.14|||||Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.|Incidence rate Symptoms involving head and neck||0.14|0.10|
72439222|NCT04425629|144392471|SUPERIORITY||Hazard Ratio (HR)|0.33|||||TWO_SIDED|95.0|0.03|3.13||||||||3.13|0.03|
72495481|NCT00930059|144520223|SUPERIORITY||LS mean difference|-0.36|STANDARD_ERROR_OF_MEAN|0.73||0.3086|TWO_SIDED|90.0|-1.56|0.84||No adjustments made for multiple comparisons.|ANCOVA|||Change at Week 6: LS mean difference and p-values were based on ANCOVA on change from baseline with treatment, baseline value, scheduled visit and visit by treatment interaction as covariates, and participant effect as random effect.||0.84|-1.56|0.3086
72495482|NCT00930059|144520223|SUPERIORITY||LS mean difference|-0.62|STANDARD_ERROR_OF_MEAN|0.73||0.197|TWO_SIDED|90.0|-1.82|0.58||No adjustments made for multiple comparisons.|ANCOVA|||Change at Week 9: LS mean difference and p-values were based on ANCOVA on change from baseline with treatment, baseline value, scheduled visit and visit by treatment interaction as covariates, and participant effect as random effect.||0.58|-1.82|0.1970
72618924|NCT01260324|144768306|SUPERIORITY_OR_OTHER_LEGACY||Incidence rate per 1000 person-years|0.14|||||TWO_SIDED|95.0|0.1|0.18|||||Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.|Incidence rate Other ill defined and unknown causes of morbidity and mortality||0.18|0.10|
72618925|NCT01260324|144768306|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|6.65|||||TWO_SIDED|95.0|4.72|9.38|||||Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.|Odds ratio Other retinal disorders||9.38|4.72|
72618926|NCT01260324|144768306|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.6|||||TWO_SIDED|95.0|1.77|3.81|||||Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.|Odds ratio Glaucoma||3.81|1.77|
72558836|NCT01451541|144647767|SUPERIORITY_OR_OTHER||LS Means with adjusted pvalues|0.59|||<|0.05||||||Multiple comparisons were adjusted for the primary and key secondary endpoints|Bonferroni-based gatekeeping method|Bonferroni-based gatekeeping method was used for multiple comparison adjustment.||Using an estimate of the standard deviation of 2.2 for the change from baseline in daily average subject-reported AM and PM rTNSS averaged over the first 6 weeks of double-blind treatment, 284 subjects per treatment group would have provided 90% power to detect a mean difference between treatment groups of 0.6 in the change from baseline with a 2-sided significance level of 0.05. Approx. 852 subjects were randomly assigned in a 1:1:1 ratio (ie, approximately 284 subjects per treatment group).||||<0.05
72618927|NCT01260324|144768306|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.31|||||TWO_SIDED|95.0|1.02|1.68|||||Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.|Odds ratio Cataract||1.68|1.02|
72618928|NCT01260324|144768306|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|14.2|||||TWO_SIDED|95.0|10.4|19.3|||||Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.|Odds ratio Visual disturbances||19.30|10.40|
72386680|NCT02975336|144281556|SUPERIORITY||Hazard Ratio (HR)|1.15||||0.5645|TWO_SIDED|95.0|0.6|2.2|||Cox proportional hazards model|||||2.20|0.60|0.5645
72386681|NCT02975336|144281557|SUPERIORITY||Odds Ratio (OR)|0.77||||0.3743|TWO_SIDED|95.0|0.44|1.37|||Regression, Logistic|||||1.37|0.44|0.3743
72386682|NCT02975336|144281557|SUPERIORITY||Odds Ratio (OR)|0.88||||0.6445|TWO_SIDED|95.0|0.5|1.54|||Regression, Logistic|||||1.54|0.50|0.6445
72386683|NCT02975336|144281557|SUPERIORITY||Odds Ratio (OR)|0.72||||0.2634|TWO_SIDED|95.0|0.41|1.28|||Regression, Logistic|||||1.28|0.41|0.2634
72386684|NCT02975336|144281558|SUPERIORITY||Rate Ratio|1.59||||0.2989|TWO_SIDED|95.0|0.66|3.81||Nominal p-value|Negative binomial regression|||||3.81|0.66|0.2989
72386685|NCT02975336|144281558|SUPERIORITY||Rate Ratio|0.85||||0.7325|TWO_SIDED|95.0|0.33|2.19||Nominal p-value|Negative binomial regression|||||2.19|0.33|0.7325
72386686|NCT02975336|144281558|SUPERIORITY||Rate Ratio|1.29||||0.591|TWO_SIDED|95.0|0.51|3.22||Nominal p-value|Negative binomial regression|||||3.22|0.51|0.5910
72386687|NCT02975336|144281559|SUPERIORITY||Odds Ratio (OR)|1.33||||0.3635|TWO_SIDED|95.0|0.72|2.47|||Regression, Logistic|||||2.47|0.72|0.3635
72386688|NCT02975336|144281559|SUPERIORITY||Odds Ratio (OR)|1.94||||0.0329|TWO_SIDED|95.0|1.06|3.56|||Regression, Logistic|||||3.56|1.06|0.0329
72386689|NCT02975336|144281559|SUPERIORITY||Odds Ratio (OR)|1.1||||0.7619|TWO_SIDED|95.0|0.59|2.07|||Regression, Logistic|||||2.07|0.59|0.7619
72386690|NCT02975336|144281560|SUPERIORITY||Odds Ratio (OR)|1.36||||0.2642|TWO_SIDED|95.0|0.79|2.35|||Regression, Logistic|||||2.35|0.79|0.2642
72386691|NCT02975336|144281560|SUPERIORITY||Odds Ratio (OR)|1.49||||0.1489|TWO_SIDED|95.0|0.87|2.57|||Regression, Logistic|||||2.57|0.87|0.1489
72386692|NCT02975336|144281560|SUPERIORITY||Odds Ratio (OR)|0.97||||0.9285|TWO_SIDED|95.0|0.56|1.7|||Regression, Logistic|||||1.70|0.56|0.9285
72386693|NCT02975336|144281563|SUPERIORITY||Odds Ratio (OR)|0.96||||0.9061|TWO_SIDED|95.0|0.49|1.88|||Regression, Logistic|||||1.88|0.49|0.9061
72386694|NCT02975336|144281563|SUPERIORITY||Odds Ratio (OR)|1.19||||0.6053|TWO_SIDED|95.0|0.61|2.31|||Regression, Logistic|||||2.31|0.61|0.6053
72386695|NCT02975336|144281563|SUPERIORITY||Odds Ratio (OR)|0.8||||0.52|TWO_SIDED|95.0|0.4|1.59|||Regression, Logistic|||||1.59|0.40|0.5200
72386696|NCT02975336|144281572|SUPERIORITY||Rate difference|5.9|||||TWO_SIDED|95.0|-9.7|21.2||||||||21.2|-9.7|
72386697|NCT02975336|144281572|SUPERIORITY||Rate Difference|0.6|||||TWO_SIDED|95.0|-14.5|15.6||||||||15.6|-14.5|
72386698|NCT02975336|144281572|SUPERIORITY||Rate difference|1.6|||||TWO_SIDED|95.0|-13.5|16.6||||||||16.6|-13.5|
72386699|NCT02975336|144281576|SUPERIORITY||Odds Ratio (OR)|1.14||||0.7728|TWO_SIDED|95.0|0.46|2.82|||Regression, Logistic|||||2.82|0.46|0.7728
72386700|NCT02975336|144281576|SUPERIORITY||Odds Ratio (OR)|0.66||||0.3314|TWO_SIDED|95.0|0.28|1.54|||Regression, Logistic|||||1.54|0.28|0.3314
72386701|NCT02975336|144281576|SUPERIORITY||Odds Ratio (OR)|0.85||||0.7205|TWO_SIDED|95.0|0.36|2.04|||Regression, Logistic|||||2.04|0.36|0.7205
72386702|NCT02975336|144281577|SUPERIORITY||Odds Ratio (OR)|1.13||||0.8364|TWO_SIDED|95.0|0.35|3.71|||Regression, Logistic|||||3.71|0.35|0.8364
72386703|NCT02975336|144281577|SUPERIORITY||Odds Ratio (OR)|1.13||||0.8287|TWO_SIDED|95.0|0.37|3.45|||Regression, Logistic|||||3.45|0.37|0.8287
72386704|NCT02975336|144281577|SUPERIORITY||Odds Ratio (OR)|1.21||||0.7621|TWO_SIDED|95.0|0.35|4.16|||Regression, Logistic|||||4.16|0.35|0.7621
72386705|NCT02975336|144281578|SUPERIORITY||Odds Ratio (OR)|0.88||||0.8464|TWO_SIDED|95.0|0.23|3.31|||Regression, Logistic|||||3.31|0.23|0.8464
72386706|NCT02975336|144281578|SUPERIORITY||Odds Ratio (OR)|0.59||||0.417|TWO_SIDED|95.0|0.16|2.12|||Regression, Logistic|||||2.12|0.16|0.4170
72386707|NCT02975336|144281578|SUPERIORITY||Odds Ratio (OR)|1.0||||0.9988|TWO_SIDED|95.0|0.27|3.74|||Regression, Logistic|||||3.74|0.27|0.9988
72386708|NCT02975336|144281579|SUPERIORITY||Odds Ratio (OR)|1.13||||0.697|TWO_SIDED|95.0|0.62|2.04|||Regression, Logistic|||||2.04|0.62|0.6970
72386709|NCT02975336|144281579|SUPERIORITY||Odds Ratio (OR)|1.34||||0.3234|TWO_SIDED|95.0|0.75|2.42|||Regression, Logistic|||||2.42|0.75|0.3234
72386710|NCT02975336|144281579|SUPERIORITY||Odds Ratio (OR)|0.99||||0.9846|TWO_SIDED|95.0|0.54|1.82|||Regression, Logistic|||||1.82|0.54|0.9846
72386711|NCT02110238|144281583|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|A VAS (0-100 mm) WOMAC Pain subscale score CFB; an equal n t-test for non-inferiority of means; a non-inferiority margin of -8 mm; change standard deviation of 26 mm; two-sided alpha=0.05; 80% power; an expected mean difference of 0, and a drop-out plus important deviation percentage of approximately 20% were used to establish study sample size.|Least square mean difference|-3.3|||||TWO_SIDED|95.0|-6.77|0.17|||||"A MERM regression model was fit to the change from baseline at weeks 3, 6, and 12. The over weeks 3, 6, and 12 single point estimate least square mean change was calculated for both arms, the difference and its 95% confidence interval calculated."|||0.17|-6.77|
72386712|NCT01419626|144281594|SUPERIORITY||Difference in LS mean|-0.461|||<|0.001|TWO_SIDED|95.0|-0.581|-0.341|||ANCOVA|||Statistical analysis at Week 4||-0.341|-0.581|<0.001
72386713|NCT01419626|144281594|SUPERIORITY||Difference in LS mean|-0.669|||<|0.001|TWO_SIDED|95.0|-0.789|-0.549|||ANCOVA|||Statistical analysis at Week 4||-0.549|-0.789|<0.001
72439223|NCT00414544|144392510|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority was tested.|Mean Difference (Final Values)|-0.13|STANDARD_DEVIATION|0.6|||TWO_SIDED|90.0|-2.0|1.0|||Confidence interval|The 90% lower confidence bound of the difference between CosmetaLife and Restylane were computed.|The confidence interval is built around the mean difference of the two reporting groups.|The a priori hypothesis for statistical analysis was based on predetermined clinical relevance being set to a difference score between CosmetaLife and Control (Restylane) of -0.5. This clinical relevance was set to -0.5 because the observation scale used is not accurate below 0.5 differences. That is CosmetaLife needed to be greater than 0.5 less than Control (Restylane) in the treatment difference scores to be considered inferior.||1.0|-2.0|
72439224|NCT00373386|144392513|SUPERIORITY_OR_OTHER|||||||0.644|||||||t-test, 2 sided|||compared with baseline||||0.644
72439225|NCT00373386|144392514|SUPERIORITY_OR_OTHER|||||||0.018||||||Versus baseline|t-test, 2 sided|paired||Compared with baseline||||0.018
72439226|NCT00373386|144392515|SUPERIORITY_OR_OTHER|||||||0.04|||||||t-test, 2 sided|||Comparison to baseline||||0.04
72439227|NCT00373386|144392516|SUPERIORITY_OR_OTHER|||||||0.004|||||||t-test, 2 sided|||Comparison with baseline||||0.004
72439228|NCT00373386|144392517|SUPERIORITY_OR_OTHER|||||||0.804|||||||t-test, 2 sided|||Comparison with baseline||||0.804
72439229|NCT00373386|144392518|SUPERIORITY_OR_OTHER|||||||0.095|||||||t-test, 2 sided|||Comparison with baseline||||0.095
72439230|NCT00373386|144392519|SUPERIORITY_OR_OTHER|||||||0.648|||||||t-test, 2 sided|||Comparison with baseline||||0.648
72439231|NCT00736853|144392575|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.377||||0.0001|TWO_SIDED|95.0|0.221|0.641|||Log Rank|Stratified Log-rank test with the target disease as the stratification factor||||0.641|0.221|0.0001
72439232|NCT02299375|144392630|SUPERIORITY_OR_OTHER||Adjusted median|1.04|STANDARD_DEVIATION|0.28|||TWO_SIDED|95.0|0.63|1.73|||||Data presented above are for 95% equal-tailed credible intervals. The estimated posterior probability that the true ratio losmapimod/placebo is \<1 assuming noninformative priors is 0.44.The estimated posterior probability that the true ratio losmapi|||1.73|0.63|
72439233|NCT02299375|144392633|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.026||||0.371|TWO_SIDED|95.0|-0.031|0.084||Analysis performed using a Mixed-effect Model Repeated Measures (MMRM) with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FEV1 pre-dose, Week 2|||0.084|-0.031|0.371
72439234|NCT02299375|144392633|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.035||||0.244|TWO_SIDED|95.0|-0.024|0.093||Analysis performed using a Mixed-effect Repeated Measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FEV1 pre-dose, Week 4|||0.093|-0.024|0.244
72439235|NCT02299375|144392633|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.059||||0.05|TWO_SIDED|95.0|0.0|0.119||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FEV1 pre-dose, Week 8|||0.119|-0.000|0.050
72439236|NCT02299375|144392633|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.002||||0.942|TWO_SIDED|95.0|-0.063|0.058||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FEV1 pre-dose, Week 12|||0.058|-0.063|0.942
72558837|NCT01451541|144647767|SUPERIORITY_OR_OTHER||LS Means with adjusted p-values.|0.47|||<|0.05||||||Multiple comparisons were adjusted for the primary and key secondary endpoints|Bonferroni-based gatekeeping method|Bonferroni-based gatekeeping method was used for multiple comparison adjustment.||Using an estimate of the standard deviation of 2.2 for the change from baseline in daily average subject-reported AM and PM rTNSS averaged over the first 6 weeks of double-blind treatment, 284 subjects per treatment group would have provided 90% power to detect a mean difference between treatment groups of 0.6 in the change from baseline with a 2-sided significance level of 0.05. Approx. 852 subjects were randomly assigned in a 1:1:1 ratio (ie, approximately 284 subjects per treatment group).||||<0.05
72439237|NCT02299375|144392633|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.05||||0.127|TWO_SIDED|95.0|-0.014|0.114||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FEV1 pre-dose, Week 18|||0.114|-0.014|0.127
72439238|NCT02299375|144392633|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.079||||0.024|TWO_SIDED|95.0|0.011|0.148||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FEV1 pre-dose, Week 26|||0.148|0.011|0.024
72439239|NCT02299375|144392633|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.086||||0.057|TWO_SIDED|95.0|-0.003|0.174||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FEV1 pre-dose, Week 39|||0.174|-0.003|0.057
72439240|NCT02299375|144392633|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.05||||0.481|TWO_SIDED|95.0|-0.09|0.191||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FEV1 pre-dose, Week 52|||0.191|-0.090|0.481
72439241|NCT02299375|144392633|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.014||||0.521|TWO_SIDED|95.0|-0.03|0.059||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FEV1 post-dose, Week 2|||0.059|-0.030|0.521
72439242|NCT02299375|144392633|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.04||||0.084|TWO_SIDED|95.0|-0.005|0.086||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FEV1 post-dose, Week 4|||0.086|-0.005|0.084
72558838|NCT02153645|144647781|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.6|STANDARD_ERROR_OF_MEAN|2.9||0.179|TWO_SIDED|95.0|-13.9|2.6|||ANCOVA|||||2.6|-13.9|0.179
72558839|NCT02153645|144647781|SUPERIORITY||Mean Difference (Final Values)|-3.1|STANDARD_ERROR_OF_MEAN|2.95||0.458|TWO_SIDED|95.0|-11.2|5.1|||ANCOVA|||||5.1|-11.2|0.458
72558840|NCT00840879|144647810|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Test/Ref Ratio of LS Means x 100|98.15||||||90.0|90.96|105.9|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||105.90|90.96|
72558841|NCT00840879|144647811|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Test/Ref Ratio of LS Means x 100|96.34||||||90.0|91.82|101.07|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||101.07|91.82|
72558842|NCT00840879|144647812|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Test/Ref Ratio of LS Means x 100|97.76||||||90.0|93.31|102.42|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||102.42|93.31|
72558843|NCT01851876|144647823|SUPERIORITY_OR_OTHER|||||||0.025||95.0|||||Fisher Exact|||||||0.025
72558844|NCT01243151|144647845|SUPERIORITY_OR_OTHER||Least Square (LS) Mean Difference|-54.68|STANDARD_ERROR_OF_MEAN|8.323|<|0.0001|TWO_SIDED|95.0|-71.37|-37.99|||ANCOVA|||Day 8: Analysis was performed using the analysis of covariance (ANCOVA) treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-37.99|-71.37|<0.0001
72386714|NCT01419626|144281594|SUPERIORITY|Statistical analysis at Week 4|Difference in LS mean|-0.208|||<|0.001|TWO_SIDED|95.0|-0.326|-0.09|||ANCOVA|||||-0.090|-0.326|<0.001
72386715|NCT01419626|144281595|SUPERIORITY||Difference in LS mean|-0.494|||<|0.001|TWO_SIDED|95.0|-0.625|-0.363|||ANCOVA|||Statistical analysis at Week 4||-0.363|-0.625|<0.001
72386716|NCT01419626|144281595|SUPERIORITY||Difference in LS mean|-0.697|||<|0.001|TWO_SIDED|95.0|-0.828|-0.567|||ANCOVA|||Statistical analysis at Week 4||-0.567|-0.828|<0.001
72386717|NCT01419626|144281595|SUPERIORITY||Difference in LS mean|-0.203||||0.002||95.0|-0.333|-0.074|||ANCOVA|||Statistical analysis at Week 4||-0.074|-0.333|0.002
72386718|NCT01419626|144281596|SUPERIORITY||Difference in LS mean|-0.04|||<|0.001|TWO_SIDED|95.0|-0.059|-0.021|||ANCOVA|||Statistical analysis at Week 2||-0.021|-0.059|<0.001
72386719|NCT01419626|144281596|SUPERIORITY||Difference in LS mean|-0.044|||<|0.001||95.0|-0.064|-0.025|||ANCOVA|||Statistical analysis at Week 2||-0.025|-0.064|<0.001
72386720|NCT01419626|144281596|SUPERIORITY||Difference in LS mean|-0.004||||0.671|TWO_SIDED|95.0|-0.023|0.015|||ANCOVA|||Statistical analysis at Week 2||0.015|-0.023|0.671
72386721|NCT01419626|144281596|SUPERIORITY||Difference in LS mean|-0.091|||<|0.001|TWO_SIDED|95.0|-0.121|-0.061|||ANCOVA|||Statistical analysis at Week 4||-0.061|-0.121|<0.001
72386722|NCT01419626|144281596|SUPERIORITY||Difference in LS mean|-0.144|||<|0.001|TWO_SIDED|95.0|-0.175|-0.114|||ANCOVA|||Statistical analysis at Week 4||-0.114|-0.175|<0.001
72386723|NCT01419626|144281596|SUPERIORITY||Difference in LS mean|-0.053|||<|0.001|TWO_SIDED|95.0|-0.083|-0.023|||ANCOVA|||Statistical analysis at Week 4||-0.023|-0.083|<0.001
72386724|NCT01419626|144281597|SUPERIORITY||Difference in LS mean|-0.09|||<|0.001|TWO_SIDED|95.0|-0.115|-0.065|||ANCOVA|||Statistical analysis at Week 2||-0.065|-0.115|<0.001
72386725|NCT01419626|144281597|SUPERIORITY||Difference in LS mean|-0.164|||<|0.001|TWO_SIDED|95.0|-0.189|-0.138|||ANCOVA|||Statistical analysis at Week 2||-0.138|-0.189|<0.001
72386726|NCT01419626|144281597|SUPERIORITY||Difference in LS mean|-0.073|||<|0.001|TWO_SIDED|95.0|-0.099|-0.048|||ANCOVA|||Statistical analysis at Week 2||-0.048|-0.099|<0.001
72386727|NCT01419626|144281597|SUPERIORITY||Difference in LS mean|-0.15|||<|0.001|TWO_SIDED|95.0|-0.18|-0.12|||ANCOVA|||Statistical analysis at Week 4||-0.120|-0.180|<0.001
72386728|NCT01419626|144281597|SUPERIORITY||Difference in LS mean|-0.257|||<|0.001|TWO_SIDED|95.0|-0.287|-0.226|||ANCOVA|||Statistical analysis at Week 4||-0.226|-0.287|<0.001
72386729|NCT01419626|144281597|SUPERIORITY||Difference in LS mean|-0.107|||<|0.001|TWO_SIDED|95.0|-0.137|-0.077|||ANCOVA|||Statistical analysis at Week 4||-0.077|-0.137|<0.001
72386730|NCT01419626|144281598|SUPERIORITY||Difference in LS mean|-0.362|||<|0.001|TWO_SIDED|95.0|-0.465|-0.259|||ANCOVA|||Statistical analysis at Week 2||-0.259|-0.465|<0.001
72386731|NCT01419626|144281598|SUPERIORITY||Difference in LS mean|-0.534|||<|0.001|TWO_SIDED|95.0|-0.637|-0.431|||ANCOVA|||Statistical analysis at Week 2||-0.431|-0.637|<0.001
72386732|NCT01419626|144281598|SUPERIORITY||Difference in LS mean|-0.171||||0.001|TWO_SIDED|95.0|-0.273|-0.069|||ANCOVA|||Statistical analysis at Week 2||-0.069|-0.273|0.001
72386733|NCT01419626|144281599|SUPERIORITY||Difference in LS mean|-0.401|||<|0.001|TWO_SIDED|95.0|-0.51|-0.292|||ANCOVA|||Statistical analysis at Week 2||-0.292|-0.510|<0.001
72386734|NCT01419626|144281599|SUPERIORITY||Difference in LS mean|-0.558|||<|0.001|TWO_SIDED|95.0|-0.667|-0.449|||ANCOVA|||Statistical analysis at Week 2||-0.449|-0.667|<0.001
72386735|NCT01419626|144281599|SUPERIORITY||Difference in LS mean|-0.157|||<|0.001|TWO_SIDED|95.0|-0.265|-0.049|||ANCOVA|||Statistical analysis at Week 2||-0.049|-0.265|<0.001
72386736|NCT01419626|144281600|SUPERIORITY||Difference in LS mean|-0.03|||<|0.001|TWO_SIDED|95.0|-0.046|-0.014|||ANCOVA|||Statistical analysis at Week 2||-0.014|-0.046|<0.001
72386737|NCT01419626|144281600|SUPERIORITY||Difference in LS mean|-0.039|||<|0.001|TWO_SIDED|95.0|-0.055|-0.023|||ANCOVA|||Statistical analysis at Week 2||-0.023|-0.055|<0.001
72386738|NCT01419626|144281600|SUPERIORITY||Difference in LS mean|-0.009||||0.294|TWO_SIDED|95.0|-0.025|0.007|||ANCOVA|||Statistical analysis at Week 2||0.007|-0.025|0.294
72558845|NCT01243151|144647845|SUPERIORITY_OR_OTHER||LS Mean Difference|-44.18|STANDARD_ERROR_OF_MEAN|8.53|<|0.0001|TWO_SIDED|95.0|-61.28|-27.08|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-27.08|-61.28|<0.0001
72439243|NCT02299375|144392633|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.033||||0.266|TWO_SIDED|95.0|-0.025|0.09||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FEV1 post-dose, Week 8|||0.090|-0.025|0.266
72439244|NCT02299375|144392633|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.012||||0.665|TWO_SIDED|95.0|-0.066|0.042||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FEV1 post-dose, Week 12|||0.042|-0.066|0.665
72439245|NCT02299375|144392633|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.023||||0.489|TWO_SIDED|95.0|-0.043|0.09||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FEV1 post-dose, Week 18|||0.090|-0.043|0.489
72439246|NCT02299375|144392633|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.099||||0.007|TWO_SIDED|95.0|0.028|0.17||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FEV1 post-dose, Week 26|||0.170|0.028|0.007
72558846|NCT01243151|144647845|SUPERIORITY_OR_OTHER||LS Mean Difference|-64.44|STANDARD_ERROR_OF_MEAN|8.433|<|0.0001|TWO_SIDED|95.0|-81.35|-47.53|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-47.53|-81.35|<0.0001
72558847|NCT01243151|144647845|SUPERIORITY_OR_OTHER||LS Mean Difference|-61.75|STANDARD_ERROR_OF_MEAN|8.282|<|0.0001|TWO_SIDED|95.0|-78.36|-45.15|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-45.15|-78.36|<0.0001
72558848|NCT01243151|144647845|SUPERIORITY_OR_OTHER||LS Mean Difference|-72.16|STANDARD_ERROR_OF_MEAN|10.097|<|0.0001|TWO_SIDED|95.0|-92.4|-51.92|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-51.92|-92.40|<0.0001
72618929|NCT01260324|144768306|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|15.1|||||TWO_SIDED|95.0|6.6|34.5|||||Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.|Odds ratio Blindness and low vision||34.50|6.60|
72439247|NCT02299375|144392633|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.055||||0.248|TWO_SIDED|95.0|-0.039|0.148||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FEV1 post-dose, Week 39|||0.148|-0.039|0.248
72439248|NCT02299375|144392633|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.043||||0.506|TWO_SIDED|95.0|-0.087|0.172||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FEV1 post-dose, Week 52|||0.172|-0.087|0.506
72439249|NCT02299375|144392633|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.051||||0.223|TWO_SIDED|95.0|-0.032|0.134||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FEV6 pre-dose, Week 2|||0.134|-0.032|0.223
72558849|NCT01243151|144647845|SUPERIORITY_OR_OTHER||LS Mean Difference|-63.89|STANDARD_ERROR_OF_MEAN|10.328|<|0.0001|TWO_SIDED|95.0|-84.59|-43.19|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-43.19|-84.59|<0.0001
72558850|NCT01243151|144647845|SUPERIORITY_OR_OTHER||LS Mean Difference|-88.69|STANDARD_ERROR_OF_MEAN|10.327|<|0.0001|TWO_SIDED|95.0|-109.39|-68.0|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-68.00|-109.39|<0.0001
72618930|NCT01260324|144768306|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.02|||||TWO_SIDED|95.0|1.44|2.82|||||Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.|Odds ratio Other disorders of eye||2.82|1.44|
72439250|NCT02299375|144392633|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.046||||0.276|TWO_SIDED|95.0|-0.037|0.129||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FEV6 pre-dose, Week 4|||0.129|-0.037|0.276
72618931|NCT01260324|144768306|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.22|||||TWO_SIDED|95.0|0.64|2.31|||||Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.|Odds ratio Occlusion and stenosis of precerebral arteries||2.31|0.64|
72618932|NCT01260324|144768306|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.29|||||TWO_SIDED|95.0|0.96|1.74|||||Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.|Odds ratio Acute sinusitis||1.74|0.96|
72618933|NCT01260324|144768306|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.34|||||TWO_SIDED|95.0|1.02|1.77|||||Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.|Odds ratio Other dermatoses||1.77|1.02|
72495483|NCT00930059|144520224|SUPERIORITY||LS mean difference|0.06|STANDARD_ERROR_OF_MEAN|0.14||0.6547|TWO_SIDED|90.0|-0.18|0.29||No adjustments made for multiple comparisons.|Linear model|||Week 3: Inferential statistics were based on linear model with fixed effects for visit (nominal scale) and visit by treatment interaction, and a random effect for participant.||0.29|-0.18|0.6547
72495484|NCT00930059|144520224|SUPERIORITY||LS mean difference|0.08|STANDARD_ERROR_OF_MEAN|0.14||0.702|TWO_SIDED|90.0|-0.16|0.31||No adjustments made for multiple comparisons.|Linear model|||Week 6: Inferential statistics were based on linear model with fixed effects for visit (nominal scale) and visit by treatment interaction, and a random effect for participant.||0.31|-0.16|0.7020
72495485|NCT00930059|144520224|SUPERIORITY||LS mean difference|-0.17|STANDARD_ERROR_OF_MEAN|0.14||0.1138|TWO_SIDED|90.0|-0.41|0.06||No adjustments made for multiple comparisons.|Linear model|||Week 9: Inferential statistics were based on linear model with fixed effects for visit (nominal scale) and visit by treatment interaction, and a random effect for participant.||0.06|-0.41|0.1138
72439251|NCT02299375|144392633|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.075||||0.131|TWO_SIDED|95.0|-0.023|0.173||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FEV6 pre-dose, Week 8|||0.173|-0.023|0.131
72439252|NCT02299375|144392633|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.003||||0.949|TWO_SIDED|95.0|-0.084|0.09||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FEV6 pre-dose, Week 12|||0.090|-0.084|0.949
72495486|NCT00930059|144520224|SUPERIORITY||LS mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.15||0.0816|TWO_SIDED|90.0|-0.44|0.04||No adjustments made for multiple comparisons.|Linear model|||Week 12: Inferential statistics were based on linear model with fixed effects for visit (nominal scale) and visit by treatment interaction, and a random effect for participant.||0.04|-0.44|0.0816
72558851|NCT01243151|144647845|SUPERIORITY_OR_OTHER||LS Mean Difference|-84.65|STANDARD_ERROR_OF_MEAN|10.028|<|0.0001|TWO_SIDED|95.0|-104.76|-64.54|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-64.54|-104.76|<0.0001
72558852|NCT01243151|144647845|SUPERIORITY_OR_OTHER||LS Mean Difference|-78.47|STANDARD_ERROR_OF_MEAN|8.854|<|0.0001|TWO_SIDED|95.0|-96.22|-60.71|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-60.71|-96.22|<0.0001
72558853|NCT01243151|144647845|SUPERIORITY_OR_OTHER||LS Mean Difference|-84.45|STANDARD_ERROR_OF_MEAN|8.998|<|0.0001|TWO_SIDED|95.0|-102.51|-66.4|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-66.40|-102.51|<0.0001
72558854|NCT01243151|144647845|SUPERIORITY_OR_OTHER||LS Mean Difference|-96.08|STANDARD_ERROR_OF_MEAN|8.994|<|0.0001|TWO_SIDED|95.0|-114.12|-78.03|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-78.03|-114.12|<0.0001
72558855|NCT01243151|144647845|SUPERIORITY_OR_OTHER||LS Mean Difference|-92.33|STANDARD_ERROR_OF_MEAN|8.703|<|0.0001|TWO_SIDED|95.0|-109.8|-74.86|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-74.86|-109.80|<0.0001
72558856|NCT01243151|144647845|SUPERIORITY_OR_OTHER||LS Mean Difference|-71.41|STANDARD_ERROR_OF_MEAN|9.534|<|0.0001|TWO_SIDED|95.0|-90.51|-52.3|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-52.30|-90.51|<0.0001
72558857|NCT01243151|144647845|SUPERIORITY_OR_OTHER||LS Mean Difference|-76.01|STANDARD_ERROR_OF_MEAN|9.659|<|0.0001|TWO_SIDED|95.0|-95.37|-56.65|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-56.65|-95.37|<0.0001
72439253|NCT02299375|144392633|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.059||||0.259|TWO_SIDED|95.0|-0.044|0.163||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FEV6 pre-dose, Week 18|||0.163|-0.044|0.259
72558858|NCT01243151|144647845|SUPERIORITY_OR_OTHER||LS Mean Difference|-93.78|STANDARD_ERROR_OF_MEAN|9.678|<|0.0001|TWO_SIDED|95.0|-113.18|-74.38|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-74.38|-113.18|<0.0001
72558859|NCT01243151|144647845|SUPERIORITY_OR_OTHER||LS Mean Difference|-89.58|STANDARD_ERROR_OF_MEAN|9.362|<|0.0001|TWO_SIDED|95.0|-108.35|-70.81|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-70.81|-108.35|<0.0001
72495487|NCT00930059|144520226|SUPERIORITY||LS mean difference|0.69|STANDARD_ERROR_OF_MEAN|0.96||0.7634|TWO_SIDED|90.0|-0.89|2.27||No adjustments have been made for multiple comparisons.|ANCOVA|||Change at Week 3: LS mean difference and p-value were based on ANCOVA on change from baseline with treatment, baseline value, scheduled visit and visit by treatment interaction as covariates, and participant effect as random effect.||2.27|-0.89|0.7634
72495488|NCT00930059|144520226|SUPERIORITY||LS mean difference|0.85|STANDARD_ERROR_OF_MEAN|0.97||0.8077|TWO_SIDED|90.0|-0.75|2.45||No adjustments made for multiple comparisons.|ANCOVA|||Change at Week 6: LS mean difference and p-value were based on ANCOVA on change from baseline with treatment, baseline value, scheduled visit and visit by treatment interaction as covariates, and participant effect as random effect.||2.45|-0.75|0.8077
72495489|NCT00930059|144520226|SUPERIORITY||LS mean difference|0.96|STANDARD_ERROR_OF_MEAN|0.98||0.835|TWO_SIDED|90.0|-0.66|2.57||No adjustments made for multiple comparisons.|ANCOVA|||Change at Week 9: LS mean difference and p-value were based on ANCOVA on change from baseline with treatment, baseline value, scheduled visit and visit by treatment interaction as covariates, and participant effect as random effect.||2.57|-0.66|0.8350
72495490|NCT00930059|144520226|SUPERIORITY||LS mean difference|-0.16|STANDARD_ERROR_OF_MEAN|0.99||0.4377|TWO_SIDED|90.0|-1.78|1.48||No adjustments made for multiple comparisons.|ANCOVA|||Change at Week 12: LS mean difference and p-value were based on ANCOVA on change from baseline with treatment, baseline value, scheduled visit and visit by treatment interaction as covariates, and participant effect as random effect.||1.48|-1.78|0.4377
72495491|NCT01641120|144520299|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Wilcoxon Signed Ranks|||||||<.05
72495492|NCT01641120|144520300|SUPERIORITY_OR_OTHER|||||||0.193|TWO_SIDED||||||Wilcoxon Signed Ranks|||||||0.193
72495493|NCT01641120|144520301|SUPERIORITY_OR_OTHER|||||||0.035|TWO_SIDED||||||Wilcoxon Signed Ranks|||||||0.035
72495494|NCT01641120|144520302|SUPERIORITY_OR_OTHER|||||||0.005|TWO_SIDED||||||Wilcoxon Signed Ranks|||||||.005
72618934|NCT01260324|144768306|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.32|||||TWO_SIDED|95.0|0.98|1.77|||||Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.|Odds ratio Other disorders of bone and cartilage||1.77|0.98|
72386739|NCT01419626|144281600|SUPERIORITY||Difference in LS mean|-0.019||||0.02|TWO_SIDED|95.0|-0.035|-0.003|||ANCOVA|||Statistical analysis at Week 4||-0.003|-0.035|0.020
72386740|NCT01419626|144281600|SUPERIORITY||Difference in LS mean|-0.034|||<|0.001|TWO_SIDED|95.0|-0.05|-0.018|||ANCOVA|||Statistical analysis at Week 4||-0.018|-0.050|<0.001
72386741|NCT01419626|144281600|SUPERIORITY||Difference in LS mean|-0.015||||0.071|TWO_SIDED|95.0|-0.031|0.001|||ANCOVA|||Statistical analysis at Week 4||0.001|-0.031|0.071
72386742|NCT01419626|144281601|SUPERIORITY||Difference in LS mean|-0.067|||<|0.001||95.0|-0.083|-0.05|||ANCOVA|||Statistical analysis at Week 2||-0.050|-0.083|<0.001
72495495|NCT03195517|144520312|OTHER|||||||0.05|||||||t-test, 1 sided|||||||0.05
72386743|NCT01419626|144281601|SUPERIORITY||Difference in LS mean|-0.083|||<|0.001|TWO_SIDED|95.0|-0.099|-0.066|||ANCOVA|||Statistical analysis at Week 2||-0.066|-0.099|<0.001
72386744|NCT01419626|144281601|SUPERIORITY||Difference in LS mean|-0.016||||0.057|TWO_SIDED|95.0|-0.032|0.0|||ANCOVA|||Statistical analysis at Week 2||0.000|-0.032|0.057
72386745|NCT01419626|144281601|SUPERIORITY||Difference in LS mean|-0.077|||<|0.001|TWO_SIDED|95.0|-0.095|-0.059|||ANCOVA|||Statistical analysis at Week 4||-0.059|-0.095|<0.001
72386746|NCT01419626|144281601|SUPERIORITY||Difference in LS mean|-0.101|||<|0.001|TWO_SIDED|95.0|-0.12|-0.083|||ANCOVA|||Statistical analysis at Week 4||-0.083|-0.120|<0.001
72386747|NCT01419626|144281601|SUPERIORITY||Difference in LS mean|-0.024||||0.009|TWO_SIDED|95.0|-0.042|-0.006|||ANCOVA|||Statistical analysis at Week 4||-0.006|-0.042|0.009
72386748|NCT01145625|144281612|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was claimed if the lower limit of the 95% Confidence Interval (CI) was greater than -6.565.|Mean Difference (Final Values)|-0.3||||0.917|TWO_SIDED|95.0|-6.0|5.4|||ANCOVA|P-Value and confidence interval are from ANCOVA model with treatment and center as factors and Baseline hair count as a covariate.||Statistical analysis is for the change from baseline to week 24 data.||5.4|-6.0|0.9170
72386749|NCT01145625|144281613|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.4|||<|0.4158|TWO_SIDED|95.0|-3.4|8.2|||ANCOVA|P-Value and confidence interval are from ANCOVA model with treatment and center as factors and Baseline hair count as a covariate.||Statistical analysis is for the change from baseline to week 12 data.||8.2|-3.4|<0.4158
72495496|NCT03195517|144520313|OTHER|||||||0.05|||||||t-test, 1 sided|||||||0.05
72495497|NCT03195517|144520314|OTHER|||||||0.05|||||||t-test, 1 sided|||||||0.05
72495498|NCT03195517|144520315|OTHER|||||||0.05|||||||t-test, 1 sided|||||||0.05
72495499|NCT03195517|144520316|OTHER|||||||0.05|||||||t-test, 1 sided|||||||0.05
72495500|NCT03195517|144520317|OTHER|||||||0.05|||||||t-test, 1 sided|||||||0.05
72495501|NCT03195517|144520318|OTHER|||||||0.05|||||||t-test, 1 sided|||||||0.05
72495502|NCT03195517|144520319|OTHER|||||||0.05|||||||t-test, 1 sided|||||||0.05
72495503|NCT03195517|144520320|OTHER|||||||0.05|||||||t-test, 1 sided|||||||0.05
72495504|NCT03195517|144520321|OTHER|||||||0.05|||||||t-test, 1 sided|||||||0.05
72495505|NCT00122135|144520384|SUPERIORITY_OR_OTHER|||||||0.77|TWO_SIDED||||||t-test, 2 sided|||||||.77
72495506|NCT01846455|144520385|SUPERIORITY_OR_OTHER||ratio of parameter means, %|99.34|||||TWO_SIDED|90.0|66.05|149.43||||||Buprenorphine||149.43|66.05|
72495507|NCT01846455|144520385|SUPERIORITY_OR_OTHER||ratio of parameter means, %|163.88|||||TWO_SIDED|90.0|110.82|242.34||||||Buprenorphine||242.34|110.82|
72495508|NCT01846455|144520385|SUPERIORITY_OR_OTHER||ratio of parameter means, %|281.43|||||TWO_SIDED|90.0|187.1|423.33||||||Buprenorphine||423.33|187.10|
72495509|NCT01846455|144520385|SUPERIORITY_OR_OTHER||ratio of parameter means, %|78.43|||||TWO_SIDED|90.0|52.14|117.98||||||Buprenorphine||117.98|52.14|
72495510|NCT01846455|144520385|SUPERIORITY_OR_OTHER||ratio of parameter means, %|126.66|||||TWO_SIDED|90.0|81.87|195.97||||||Buprenorphine||195.97|81.87|
72495511|NCT01846455|144520385|SUPERIORITY_OR_OTHER||ratio of parameter means, %|208.94|||||TWO_SIDED|90.0|137.21|318.18||||||Buprenorphine||318.18|137.21|
72495512|NCT01846455|144520385|SUPERIORITY_OR_OTHER||ratio of parameter means, %|358.83|||||TWO_SIDED|90.0|231.92|555.17||||||Buprenorphine||555.17|231.92|
72495513|NCT01846455|144520385|SUPERIORITY_OR_OTHER||ratio of parameter means, %|78.09|||||TWO_SIDED|90.0|44.03|138.49||||||Norbuprenorphine||138.49|44.03|
72495514|NCT01846455|144520385|SUPERIORITY_OR_OTHER||ratio of parameter means, %|74.78|||||TWO_SIDED|90.0|39.26|142.41||||||Norbuprenorphine||142.41|39.26|
72495515|NCT01846455|144520385|SUPERIORITY_OR_OTHER||ratio of parameter means, %|11.45|||||TWO_SIDED|90.0|6.35|20.66||||||Norbuprenorphine||20.66|6.35|
72495516|NCT01846455|144520385|SUPERIORITY_OR_OTHER||ratio of parameter means, %|71.08|||||TWO_SIDED|90.0|39.0|129.49||||||Norbuprenorphine||129.49|39.00|
72495517|NCT01846455|144520385|SUPERIORITY_OR_OTHER||ratio of parameter means, %|109.9|||||TWO_SIDED|90.0|58.14|207.75||||||Norbuprenorphine||207.75|58.14|
72495518|NCT01846455|144520385|SUPERIORITY_OR_OTHER||ratio of parameter means, %|105.23|||||TWO_SIDED|90.0|52.17|212.24||||||Norbuprenorphine||212.24|52.17|
72495519|NCT01846455|144520385|SUPERIORITY_OR_OTHER||ratio of parameter means, %|16.12|||||TWO_SIDED|90.0|8.4|30.94||||||Norbuprenorphine||30.94|8.40|
72386750|NCT01145625|144281614|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.5||||0.598|TWO_SIDED|95.0|-7.1|4.1|||ANCOVA|P-value and confidence interval are from ANCOVA model with treatment and center as factors and Baseline hair count as a covariate.||Statistical analysis is for the change from baseline to week 52 data.||4.1|-7.1|0.5980
72439254|NCT02299375|144392633|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.073||||0.152|TWO_SIDED|95.0|-0.027|0.172||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FEV6 pre-dose, Week 26|||0.172|-0.027|0.152
72439255|NCT02299375|144392633|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.114||||0.076|TWO_SIDED|95.0|-0.012|0.241||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FEV6 pre-dose, Week 39|||0.241|-0.012|0.076
72439256|NCT02299375|144392633|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.171||||0.107|TWO_SIDED|95.0|-0.038|0.381||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FEV6 pre-dose, Week 52|||0.381|-0.038|0.107
72439257|NCT02299375|144392633|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.025||||0.484|TWO_SIDED|95.0|-0.046|0.097||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FEV6 post-dose, Week 2|||0.097|-0.046|0.484
72439258|NCT02299375|144392633|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.037||||0.256|TWO_SIDED|95.0|-0.027|0.1||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FEV6 post-dose, Week 4|||0.100|-0.027|0.256
72439259|NCT02299375|144392633|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.052||||0.184|TWO_SIDED|95.0|-0.025|0.128||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FEV6 post-dose, Week 8|||0.128|-0.025|0.184
72439260|NCT02299375|144392633|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.001||||0.97|TWO_SIDED|95.0|-0.077|0.074||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FEV6 post-dose, Week 12|||0.074|-0.077|0.970
72439261|NCT02299375|144392633|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.025||||0.608|TWO_SIDED|95.0|-0.07|0.12||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FEV6 post-dose, Week 18|||0.120|-0.070|0.608
72439262|NCT02299375|144392633|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.084||||0.071|TWO_SIDED|95.0|-0.007|0.175||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FEV6 post-dose, Week 26|||0.175|-0.007|0.071
72439263|NCT02299375|144392633|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.028||||0.622|TWO_SIDED|95.0|-0.085|0.141||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FEV6 post-dose, Week 39|||0.141|-0.085|0.622
72439264|NCT02299375|144392633|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.102||||0.277|TWO_SIDED|95.0|-0.086|0.291||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FEV6 post-dose, Week 52|||0.291|-0.086|0.277
72439265|NCT02299375|144392633|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.056||||0.241|TWO_SIDED|95.0|-0.038|0.15||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FVC Pre-dose, Week 2|||0.150|-0.038|0.241
72386751|NCT03779711|144281638|SUPERIORITY|||||||0.8095|||||||ANCOVA|adjusted for baseline FAC||Analysis of covariance (ANCOVA), adjusted for baseline FAC, is used to assess change in FAC from baseline to 3-months post-surgery.||||0.8095
72386752|NCT03779711|144281639|SUPERIORITY|||||||0.3029|||||||ANCOVA|Adjusted for baseline circumferential strain||Analysis of covariance (ANCOVA), adjusted for baseline circumferential strain, is used to assess change in circumferential strain from baseline to 3-months post-surgery.||||0.3029
72386753|NCT03779711|144281640|SUPERIORITY|||||||0.0323|||||||ANCOVA|Adjusted for baseline longitudinal strain||Analysis of covariance (ANCOVA), adjusted for baseline longitudinal strain, is used to assess change in longitudinal strain from baseline to 3-months post-surgery.||||0.0323
72386754|NCT03779711|144281641|SUPERIORITY|||||||0.6765|||||||ANCOVA|Adjusted for baseline FAC.||Analysis of covariance (ANCOVA), adjusted for baseline FAC, is used to assess change in FAC from baseline to 12-months post-surgery.||||0.6765
72439266|NCT02299375|144392633|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.045||||0.348|TWO_SIDED|95.0|-0.049|0.14|||MMRM||FVC Pre-dose, Week 4|||0.140|-0.049|0.348
72386755|NCT03779711|144281642|SUPERIORITY|||||||0.3456|||||||ANCOVA|Adjusted for baseline FAC||Analysis of covariance (ANCOVA), adjusted for baseline FAC, is used to assess change in FAC from baseline to discharge.||||0.3456
72386756|NCT03779711|144281643|SUPERIORITY|||||||0.776|||||||Kruskal-Wallis|||Kruskal-Wallis test comparing number of days in hospital post stage-II surgery.||||0.7760
72386757|NCT03779711|144281644|SUPERIORITY|||||||0.9563|||||||Kruskal-Wallis|||Kruskal-Wallis test for change in weight from baseline to 3-months post-surgery.||||0.9563
72386758|NCT03779711|144281645|SUPERIORITY|||||||0.9095|||||||Kruskal-Wallis|||Kruskal-Wallis test for change in heart rate from baseline to 3-months post-surgery.||||0.9095
72386759|NCT03779711|144281646|SUPERIORITY|||||||0.6391|||||||Kruskal-Wallis|||Kruskal-Wallis test for change in oxygen saturation from baseline to 3-months post-surgery.||||0.6391
72386760|NCT03779711|144281653|SUPERIORITY|||||||0.8782|||||||Kruskal-Wallis|||Kruskal-Wallis test comparing number of days in hospital post stage-II surgery||||0.8782
72558860|NCT01243151|144647846|SUPERIORITY_OR_OTHER||LS Mean Difference|-33.82|STANDARD_ERROR_OF_MEAN|5.077|<|0.0001|TWO_SIDED|95.0|-43.99|-23.65|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-23.65|-43.99|<0.0001
72618935|NCT01260324|144768306|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.37|||||TWO_SIDED|95.0|1.02|1.84|||||Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.|Odds ratio Symptoms involving head and neck||1.84|1.02|
72386761|NCT05224141|144281654|SUPERIORITY||Hazard Ratio (HR)|1.26||||0.9762|TWO_SIDED|95.0|1.0|1.59|||Log Rank|One-sided p-value based on log-rank test stratified by ECOG performance status, LDH, liver metastasis, and brain metastasis.|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG performance status (0 vs. 1), LDH (≤ULN vs. \>ULN), liver metastasis (Yes or No), and brain metastasis (Yes or No).|Statistical analyses stratified by ECOG performance status (0 vs. 1), LDH (≤ULN vs. \>ULN), liver metastasis (Yes or No), and brain metastasis (Yes or No).||1.59|1.00|0.9762
72386762|NCT05224141|144281655|SUPERIORITY||Hazard Ratio (HR)|1.01||||0.5316|TWO_SIDED|95.0|0.82|1.23|||Log Rank|One-sided p-value based on log-rank test stratified by ECOG performance status, LDH, liver metastasis, and brain metastasis.|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG performance status (0 vs. 1), LDH (≤ULN vs. \>ULN), liver metastasis (Yes or No), and brain metastasis (Yes or No).|Statistical analyses stratified by ECOG performance status (0 vs. 1), LDH (≤ULN vs. \>ULN), liver metastasis (Yes or No), and brain metastasis (Yes or No).||1.23|0.82|0.5316
72386763|NCT05224141|144281656|SUPERIORITY||Percent Difference|-3.1|||||TWO_SIDED|95.0|-11.1|4.9|||||Based on Miettinen \& Nurminen method stratified by ECOG performance status (0 vs. 1), LDH (≤ULN vs. \>ULN), liver metastasis (Yes or No), and brain metastasis (Yes or No).|Statistical analyses stratified by ECOG performance status (0 vs. 1), LDH (≤ULN vs. \>ULN), liver metastasis (Yes or No), and brain metastasis (Yes or No).||4.9|-11.1|
72386764|NCT03469934|144281677|OTHER||Least Squares (LS) Mean Difference|-0.058||||0.5703|TWO_SIDED|95.0|-0.265|0.15|||Mixed-model repeated measures|||Mixed-model repeated measures (MMRM) analysis with fixed terms for treatment, time point of measurement, and treatment by time point interaction, baseline eosinophil count as a covariate, and a repeated time point effect within a participant.||0.150|-0.265|0.5703
72386765|NCT03469934|144281681|OTHER||LS Mean Difference|-0.05||||0.5901|TWO_SIDED|95.0|-0.239|0.139|||Mixed-model repeated measures|||MMRM analysis with fixed terms for treatment, time point of measurement, and treatment by time point interaction, baseline eosinophil count as a covariate, and a repeated time point effect within a participant.||0.139|-0.239|0.5901
72386766|NCT03469934|144281682|OTHER||LS Mean Difference|0.09|STANDARD_ERROR_OF_MEAN|0.164||0.596|TWO_SIDED|95.0|-0.25|0.43|||ANCOVA|||Change from baseline for FEV1 was compared between etokimab and placebo using an analysis of covariance (ANCOVA) with treatment as fixed effect and baseline result as covariate and participant as a random effect||0.43|-0.25|0.5960
72386767|NCT03469934|144281683|OTHER||LS Mean Difference|2.53|STANDARD_ERROR_OF_MEAN|9.823||0.7993|TWO_SIDED|95.0|-17.9|22.96|||ANCOVA|||Change from baseline for FeNO was compared between etokimab and placebo using an ANCOVA with treatment as fixed effect and baseline result as covariate and participant as a random effect||22.96|-17.90|0.7993
72386768|NCT03881670|144281695|OTHER|Friedman test||||||0.0023|||||||Friedman Test|||Change in ratings over time||||0.0023
72386769|NCT03881670|144281695|OTHER|Friedman test||||||0.4679|||||||Friedman Test|||change in ratings over time||||0.4679
72386770|NCT00914485|144281697|SUPERIORITY_OR_OTHER|||||||0.03|TWO_SIDED||||||t-test, 1 sided|||Increase in mean, post-intervention versus baseline, across 18 providers and 369 patients.||||.03
72386771|NCT04889222|144281699|EQUIVALENCE|A TOST procedure using the Wilcoxon Rank Sum Test was used to test the hypothesis that the median biases of the INVSENSOR00050 sensor from two pigmentation subgroups (Light and Dark) were equivalent within ± 1 %SpO2. The TOST procedure provides a p-value indicating whether the two measures are equivalent if the p-value is less than 0.05.||||||0.00097||||||The a priori threshold for p-value was 0.05.|Two One Sided Tests (TOST)|||||||0.00097
72386772|NCT04889222|144281700|EQUIVALENCE|A TOST procedure using the Wilcoxon Rank Sum Test was used to test the hypothesis that the median biases of the RD SET SpO2 sensor from two pigmentation subgroups (Light and Dark) were equivalent within ± 1 %SpO2. The TOST procedure provides a p-value indicating whether the two measures are equivalent if the p-value is less than 0.05.||||||0||||||The a priori threshold for p-value was 0.05.|Two One-Sided Tests (TOST)|||||||0.00000
72386773|NCT04873700|144281711|SUPERIORITY||||||=|0.0701|||||||Chi-squared|p-value was obtained from Chi-square/Fisher's exact test.||Location of disease||||=0.0701
72386774|NCT04873700|144281711|SUPERIORITY||||||=|0.1383|||||||Chi-squared|p-value was obtained from Chi-square/Fisher's exact test.||Disease behavior||||=0.1383
72386775|NCT04873700|144281711|SUPERIORITY||||||=|0.0478|||||||Chi-squared|p-value was obtained from Chi-square/Fisher's exact test.||Perianal disease||||=0.0478
72386776|NCT04873700|144281711|SUPERIORITY||||||=|0.1454|||||||Chi-squared|p-value was obtained from Chi-square/Fisher's exact test.||Ileal disease||||=0.1454
72386777|NCT04873700|144281711|SUPERIORITY||||||=|1|||||||Chi-squared|p-value was obtained from Chi-square/Fisher's exact test.||Extraintestinal manifestations: Peripheral arthritis||||=1.0000
72386778|NCT04873700|144281711|SUPERIORITY||||||=|0.4992|||||||Chi-squared|p-value was obtained from Chi-square/Fisher's exact test.||Extraintestinal manifestations: Aphthous ulcers||||=0.4992
72386779|NCT04873700|144281711|SUPERIORITY||||||=|1|||||||Chi-squared|p-value was obtained from Chi-square/Fisher's exact test.||Extraintestinal manifestations: Episcleritis||||=1.0000
72386780|NCT04873700|144281711|SUPERIORITY||||||=|1|||||||Chi-squared|p-value was obtained from Chi-square/Fisher's exact test.||Extraintestinal manifestations: Uveitis||||=1.0000
72386781|NCT04873700|144281711|SUPERIORITY||||||=|1|||||||Chi-squared|p-value was obtained from Chi-square/Fisher's exact test.||Extraintestinal manifestations: Osteoporosis||||=1.0000
72386782|NCT04873700|144281711|SUPERIORITY||||||=|0.2022|||||||Chi-squared|p-value was obtained from Chi-square/Fisher's exact test.||Extraintestinal manifestations: Anemia||||=0.2022
72386783|NCT04873700|144281711|SUPERIORITY||||||=|1|||||||Chi-squared|p-value was obtained from Chi-square/Fisher's exact test.||Extraintestinal manifestations: Hematological alteration||||=1.0000
72386784|NCT04873700|144281711|SUPERIORITY||||||=|0|||||||Chi-squared|p-value was obtained from Chi-square/Fisher's exact test.||Extraintestinal manifestations: Other||||=0.0000
72386785|NCT04873700|144281712|SUPERIORITY||||||=|0.2896|||||||Chi-squared|p-value was obtained from Chi-square/Fisher's exact test.||Location of disease||||=0.2896
72386786|NCT04873700|144281712|SUPERIORITY||||||=|0.0006|||||||Chi-squared|p-value was obtained from Chi-square/Fisher's exact test.||Disease behavior||||=0.0006
72386787|NCT04873700|144281712|SUPERIORITY||||||=|0.089|||||||Chi-squared|p-value was obtained from Chi-square/Fisher's exact test.||Extraintestinal manifestations: Peripheral arthritis||||=0.0890
72386788|NCT04873700|144281712|SUPERIORITY||||||=|1|||||||Chi-squared|p-value was obtained from Chi-square/Fisher's exact test.||Extraintestinal manifestations: Pyoderma gangrenosum||||=1.0000
72386789|NCT04873700|144281712|SUPERIORITY||||||=|1|||||||Chi-squared|p-value was obtained from Chi-square/Fisher's exact test.||Extraintestinal manifestations: Aphthous ulcers||||=1.0000
72386790|NCT04873700|144281712|SUPERIORITY||||||=|1|||||||Chi-squared|p-value was obtained from Chi-square/Fisher's exact test.||Extraintestinal manifestations: Primary sclerosing cholangitis||||=1.0000
72386791|NCT04873700|144281712|SUPERIORITY||||||=|1|||||||Chi-squared|p-value was obtained from Chi-square/Fisher's exact test.||Extraintestinal manifestations: Osteoporosis||||=1.0000
72386792|NCT04873700|144281712|SUPERIORITY||||||=|0.0752|||||||Chi-squared|p-value was obtained from Chi-square/Fisher's exact test.||Extraintestinal manifestations: Anemia||||=0.0752
72386793|NCT04873700|144281712|SUPERIORITY||||||=|1|||||||Chi-squared|p-value was obtained from Chi-square/Fisher's exact test.||Extraintestinal manifestations: Hematological alteration||||=1.0000
72386794|NCT04873700|144281712|SUPERIORITY||||||=|0.1032|||||||Chi-squared|p-value was obtained from Chi-square/Fisher's exact test.||Extraintestinal manifestations: Other||||=0.1032
72386795|NCT00113087|144281759|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.18||0.28|TWO_SIDED|95.0|||||Mixed Models Analysis|||||||0.28
72386796|NCT00113087|144281760|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.14||||0.42||95.0|||||Mixed Models Analysis|||||||0.42
72386797|NCT00113087|144281761|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.64||||0.008||95.0|||||Mixed Models Analysis|||||||0.008
72386798|NCT00113087|144281762|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|||||||1.00
72386799|NCT00113087|144281763|SUPERIORITY_OR_OTHER|||||||0.71||95.0|||||Fisher Exact|||||||0.71
72386800|NCT00113087|144281764|SUPERIORITY_OR_OTHER|||||||0.74||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.74
72386801|NCT00113087|144281765|SUPERIORITY_OR_OTHER|||||||0.22||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.22
72386802|NCT00113087|144281766|SUPERIORITY_OR_OTHER|||||||0.86||95.0|||||t-test, 2 sided|||||||0.86
72386803|NCT00113087|144281767|SUPERIORITY_OR_OTHER|||||||0.6||95.0|||||t-test, 2 sided|||||||0.60
72386804|NCT00113087|144281768|SUPERIORITY_OR_OTHER|||||||0.6||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.60
72386805|NCT00113087|144281769|SUPERIORITY_OR_OTHER|||||||0.01||95.0|||||t-test, 2 sided|||||||0.01
72386806|NCT00113087|144281770|SUPERIORITY_OR_OTHER|||||||0.008||95.0|||||t-test, 2 sided|||||||0.008
72386807|NCT00113087|144281771|SUPERIORITY_OR_OTHER|||||||0.004||95.0|||||t-test, 2 sided|||||||0.004
72386808|NCT00113087|144281772|SUPERIORITY_OR_OTHER|||||||0.31||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.31
72386809|NCT00113087|144281773|SUPERIORITY_OR_OTHER|||||||0.36||95.0|||||t-test, 2 sided|||||||0.36
72386810|NCT00113087|144281774|SUPERIORITY_OR_OTHER|||||||0.37||95.0|||||t-test, 2 sided|||||||0.37
72386811|NCT00113087|144281775|SUPERIORITY_OR_OTHER|||||||0.08||95.0|||||t-test, 2 sided|||||||0.08
72386812|NCT00113087|144281776|SUPERIORITY_OR_OTHER|||||||0.07||95.0|||||t-test, 2 sided|||||||0.07
72386813|NCT00113087|144281777|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||t-test, 2 sided|||||||0.05
72386814|NCT00113087|144281778|SUPERIORITY_OR_OTHER|||||||0.11||95.0|||||t-test, 2 sided|||||||0.11
72386815|NCT00113087|144281779|SUPERIORITY_OR_OTHER|||||||0.49||95.0|||||t-test, 2 sided|||||||0.49
72386816|NCT00113087|144281780|SUPERIORITY_OR_OTHER|||||||0.35||95.0|||||t-test, 2 sided|||||||0.35
72386817|NCT00113087|144281781|SUPERIORITY_OR_OTHER|||||||0.62||95.0|||||t-test, 2 sided|||||||0.62
72386818|NCT00113087|144281782|SUPERIORITY_OR_OTHER|||||||0.43||95.0|||||t-test, 2 sided|||||||0.43
72386819|NCT00113087|144281783|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||t-test, 2 sided|||||||0.02
72386820|NCT00113087|144281784|SUPERIORITY_OR_OTHER|||||||0.34||95.0|||||t-test, 2 sided|||||||0.34
72386821|NCT00113087|144281785|SUPERIORITY_OR_OTHER|||||||0.81||95.0|||||t-test, 2 sided|||||||.81
72386822|NCT00113087|144281786|SUPERIORITY_OR_OTHER|||||||0.08||95.0|||||Fisher Exact|||||||0.08
72386823|NCT00113087|144281787|SUPERIORITY_OR_OTHER|||||||0.06||95.0|||||Fisher Exact|||||||0.06
72386824|NCT00810693|144281800|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Prespecified significance level for all significance tests was 5%. Primary analysis due to result of Shapiro-Wilk test.|Wilcoxon (Mann-Whitney)|Test was stratified by region and therapy naive/add-on therapy||Missing values for participants who withdrew/died before 12 weeks were imputed with worst value of 0m in case of death or clinical worsening without termination visit and with last observed value otherwise. Comparison was done using ANCOVA, with baseline 6MWD as a covariate and treatment group, region and treatment naive/add-on therapy as main effects. The primary statistical method was the stratified Wilcoxon test if the Shapiro-Wilk test for normality of residuals was statistically significant||||<0.0001
72386825|NCT00810693|144281800|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|35.78|||<|0.0001|TWO_SIDED|95.0|20.06|51.51||Additional analysis due to result of Shapiro-Wilk test.|ANCOVA|||||51.51|20.06|<0.0001
72386826|NCT00810693|144281800|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0001|||||||Shapiro-Wilk|||Shapiro-Wilk test for normality of ANCOVA residuals.||||0.0001
72386827|NCT00810693|144281801|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Hierarchical testing for secondary efficacy parameters in the order: PVR, NT-proBNP, WHO functional class, TTCW, Borg scale, EQ5D, LPH. Primary analysis due to result of Shapiro-Wilk test.|Wilcoxon (Mann-Whitney)|Test was stratified by region and therapy naive/add-on therapy||Missing values at week 12 were imputed using the last available post-baseline observation. Same analysis method as for primary efficacy parameter.||||<0.0001
72558861|NCT01243151|144647846|SUPERIORITY_OR_OTHER||LS Mean Difference|-27.93|STANDARD_ERROR_OF_MEAN|5.202|<|0.0001|TWO_SIDED|95.0|-38.35|-17.51|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-17.51|-38.35|<0.0001
72558862|NCT01243151|144647846|SUPERIORITY_OR_OTHER||LS Mean Difference|-39.59|STANDARD_ERROR_OF_MEAN|5.143|<|0.0001|TWO_SIDED|95.0|-49.89|-29.28|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-29.28|-49.89|<0.0001
72558863|NCT01243151|144647846|SUPERIORITY_OR_OTHER||LS Mean Difference|-37.63|STANDARD_ERROR_OF_MEAN|5.051|<|0.0001|TWO_SIDED|95.0|-47.75|-27.51|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-27.51|-47.75|<0.0001
72386828|NCT00810693|144281801|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-225.72|||<|0.0001|TWO_SIDED|95.0|-281.37|-170.08||Additional analysis due to result of Shapiro-Wilk test.|ANCOVA|||||-170.08|-281.37|<0.0001
72386829|NCT00810693|144281801|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0001|||||||Shapiro-Wilk|||Shapiro-Wilk test for normality of ANCOVA residuals.||||0.0001
72386830|NCT00810693|144281802|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||"Hierarchical testing for secondary efficacy parameters in the order: PVR, NT-proBNP, WHO functional class, Time to clinical worsening, Borg scale, EQ5D, LPH.~Primary analysis due to result of Shapiro-Wilk test."|Wilcoxon (Mann-Whitney)|Test was stratified by region and therapy naive/add-on therapy||Missing values at week 12 were imputed using the last available post-baseline observation. Same analysis method as for primary efficacy parameter.||||<0.0001
72386831|NCT00810693|144281802|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-431.81||||0.0157|TWO_SIDED|95.0|-781.52|-82.1||Additional analysis due to result of Shapiro-Wilk test.|ANCOVA|||||-82.10|-781.52|0.0157
72386832|NCT00810693|144281802|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0001|||||||Shapiro-Wilk|||Shapiro-Wilk test for normality of ANCOVA residuals.||||0.0001
72386833|NCT00810693|144281803|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0033||||||Hierarchical testing for secondary efficacy parameters in the order: PVR, NT-proBNP, WHO functional class, Time to clinical worsening, Borg scale, EQ5D, LPH.|Wilcoxon (Mann-Whitney)|Test was stratified by region and therapy naive/add-on therapy||Missing values for participants who withdrew or died before 12 weeks were imputed with a worst value of IV in case of clinical worsening without termination visit or measurement at that termination visit and with a worst value of V in case of death and with the last observed value otherwise.||||0.0033
72386834|NCT00810693|144281804|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|-5.2||||0.0046|TWO_SIDED|95.0|-9.85|-0.55||Hierarchical testing for secondary efficacy parameters in the order: PVR, NT-proBNP, WHO functional class, Time to clinical worsening, Borg scale, EQ5D, LPH.|Log Rank|Test was stratified by region and therapy naive/add-on therapy|Based on Mantel-Haenszel estimate stratified by region and therapy naive/add-on therapy.|"The test is for difference of occurence of Any event."||-0.55|-9.85|0.0046
72386835|NCT00810693|144281805|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0022||||||Hierarchical testing for secondary efficacy parameters in the order: PVR, NT-proBNP, WHO functional class, Time to clinical worsening, Borg scale, EQ5D, LPH.|Wilcoxon (Mann-Whitney)|Test was stratified by region and therapy naive/add-on therapy||Missing values for participants who withdrew or died before 12 weeks were imputed with a worst value of 10 in case of death or clinical worsening without termination visit and with the last observed value otherwise.||||0.0022
72386836|NCT00810693|144281806|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0663||||||Hierarchical testing for secondary efficacy parameters in the order: PVR, NT-proBNP, WHO functional class, Time to clinical worsening, Borg scale, EQ5D, LPH. Primary analysis due to result of Shapiro-Wilk test.|Wilcoxon (Mann-Whitney)|Test was stratified by region and therapy naive/add-on therapy.||Missing values at baseline were imputed using last available observation prior to start of study treatment. Missing values for participants who withdrew or died before 12 weeks were imputed with a worst value of -0.594 in case of death or clinical worsening without termination visit and with the last observed value otherwise.||||0.0663
72386837|NCT00810693|144281806|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.06||||0.0197|TWO_SIDED|95.0|0.01|0.11||Additional analysis due to result of Shapiro-Wilk test.|ANCOVA|||||0.11|0.01|0.0197
72386838|NCT00810693|144281806|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0001|||||||Shapiro-Wilk|||Shapiro-Wilk test for normality of ANCOVA residuals.||||0.0001
72386839|NCT00810693|144281807|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0019||||||"Hierarchical testing for secondary efficacy parameters in the order: PVR, NT-proBNP, WHO FC, TTCW, Borg scale, EQ5D, LPH.~Primary analysis due to result of Shapiro-Wilk test. Nominally significant only due to hierarchical testing."|Wilcoxon (Mann-Whitney)|Test was stratified by region and therapy naive/add-on therapy.||Missing values at baseline were imputed using last available observation prior to start of study treatment. Missing values for participants who withdrew or died before 12 weeks were imputed with a worst value of 105 in case of death or clinical worsening without termination visit and with the last observed value otherwise.||||0.0019
72386840|NCT00810693|144281807|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.17||||0.0009|TWO_SIDED|95.0|-9.79|-2.54||Additional analysis due to result of Shapiro-Wilk test.|ANCOVA|||||-2.54|-9.79|0.0009
72386841|NCT00810693|144281807|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0001|||||||Shapiro-Wilk|||Shapiro-Wilk test for normality of ANCOVA residuals.||||0.0001
72386842|NCT00467857|144281854|SUPERIORITY_OR_OTHER|||||||0.655||95.0|||||Wilcoxon-Rank Sum Test|||The sample size determination was selected to achieve 80% power to detect an absolute 10% difference between the two treatment groups in proportion of qualitative reduction in representative skin flora, at a significance level (alpha) of 0.05 using a two-sided z-test with continuity correction.||||0.655
72386843|NCT00467857|144281855|SUPERIORITY_OR_OTHER|||||||0.276||95.0|||||Wilcoxon-Rank Sum Test|||||||0.276
72386844|NCT00467857|144281856|SUPERIORITY_OR_OTHER|||||||0.375||95.0|||||Wilcoxon-Rank Sum Test|||||||0.375
72386845|NCT00467857|144281857|SUPERIORITY_OR_OTHER|||||||0.039||95.0|||||Wilcoxon-Rank Sum Test|||||||0.039
72386846|NCT00467857|144281858|SUPERIORITY_OR_OTHER|||||||0.057||95.0|||||Wilcoxon-Rank Sum Test|||||||0.057
72386847|NCT00467857|144281859|SUPERIORITY_OR_OTHER|||||||0.646||95.0|||||Wilcoxon-Rank Sum Test|||||||0.646
72558864|NCT01243151|144647846|SUPERIORITY_OR_OTHER||LS Mean Difference|-45.99|STANDARD_ERROR_OF_MEAN|6.384|<|0.0001|TWO_SIDED|95.0|-58.78|-33.2|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-33.20|-58.78|<0.0001
72558865|NCT01243151|144647846|SUPERIORITY_OR_OTHER||LS Mean Difference|-41.82|STANDARD_ERROR_OF_MEAN|6.527|<|0.0001|TWO_SIDED|95.0|-54.9|-28.74|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-28.74|-54.90|<0.0001
72558866|NCT01243151|144647846|SUPERIORITY_OR_OTHER||LS Mean Difference|-56.35|STANDARD_ERROR_OF_MEAN|6.531|<|0.0001|TWO_SIDED|95.0|-69.43|-43.27|||ANCOVA|||Day 15: Analysis was performed using ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-43.27|-69.43|<0.0001
72558867|NCT01243151|144647846|SUPERIORITY_OR_OTHER||LS Mean Difference|-53.45|STANDARD_ERROR_OF_MEAN|6.344|<|0.0001|TWO_SIDED|95.0|-66.17|-40.74|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-40.74|-66.17|<0.0001
72386848|NCT00467857|144281860|SUPERIORITY_OR_OTHER|||||||0.788||95.0|||||Wilcoxon-Rank Sum Test|||||||0.788
72386849|NCT00467857|144281861|SUPERIORITY_OR_OTHER|||||||0.96||95.0|||||Wilcoxon-Rank Sum Test|||||||0.960
72386850|NCT00467857|144281862|SUPERIORITY_OR_OTHER|||||||0.359||95.0|||||Wilcoxon-Rank Sum Test|||The sample size determination was selected to achieve 80% power to detect an absolute 10% difference between the two treatment groups in proportion of qualitative reduction in representative skin flora, at a significance level (alpha) of 0.05 using a two-sided z-test with continuity correction.||||0.359
72386851|NCT00467857|144281863|SUPERIORITY_OR_OTHER|||||||0.73||95.0|||||Wilcoxon-Rank Sum Test|||||||0.730
72386852|NCT00467857|144281864|SUPERIORITY_OR_OTHER|||||||0.348||95.0|||||Wilcoxon-Rank Sum Test|||||||0.348
72386853|NCT00467857|144281865|SUPERIORITY_OR_OTHER|||||||0.512||95.0|||||Wilcoxon-Rank Sum Test|||||||0.512
72386854|NCT00467857|144281866|SUPERIORITY_OR_OTHER|||||||0.285||95.0|||||Chi-squared|||||||0.285
72386855|NCT00467857|144281867|SUPERIORITY_OR_OTHER|||||||0.024||95.0|||||Fisher Exact|||||||0.024
72386856|NCT03576495|144281881|SUPERIORITY|"We conducted a superiority statistical test to assess if residents' knowledge improved after exposure to the PACTS curriculum. For purposes of measuring an effect of the PACTS curriculum on resident knowledge, resident knowledge was compared at time Period 2 between the Early Intervention (intervention) and Delayed Intervention (control) groups."|Mean Difference (Final Values)|2.6||||0.2422|TWO_SIDED|||||This p-value compares the average scores (in percent) of the residents' knowledge assessment at time period 2 between the Early Intervention and Delayed Intervention groups.|t-test, 2 sided|||||||0.2422
72386857|NCT03576495|144281882|SUPERIORITY||Difference between percentage|0.0||||1|TWO_SIDED||||||Chi-squared|||"We conducted a superiority statistical test to assess if residents' preparation for caring for culturally diverse patients improved after exposure to the PACTS curriculum. For purposes of measuring an effect of the PACTS curriculum on resident preparedness assessed by the Cross-Cultural Care Survey, resident preparedness was compared at time Period 2 between the Early Intervention (intervention) and Delayed Intervention (control) groups."||||1.000
72386858|NCT03576495|144281883|SUPERIORITY||Percent difference|0.9||||0.6295|TWO_SIDED||||||Chi-squared|||"We conducted a superiority statistical test to assess if residents' self-assessed skills improved after exposure to the PACTS curriculum. For purposes of measuring an effect of the PACTS curriculum on resident skills, resident skills were compared at time Period 2 between the Early Intervention (intervention) and Delayed Intervention (control) groups."||||0.6295
72386859|NCT03576495|144281884|SUPERIORITY||Difference between percentage|2.5||||0.0199|TWO_SIDED||||||Fisher Exact|||"We conducted a superiority statistical test to assess if residents' beliefs improved after exposure to the PACTS curriculum. For purposes of measuring an effect of the PACTS curriculum on resident beliefs, beliefs were compared at time Period 2 between the Early Intervention (intervention) and Delayed Intervention (control) groups."||||0.0199
72386860|NCT03576495|144281885|SUPERIORITY||difference in the percentage|2.2||||0.2665|TWO_SIDED||||||Chi-squared|||"We conducted a superiority statistical test to assess if residents' OSCE performance improved after exposure to the PACTS curriculum. OSCE performance was compared at time Period 2 between the Early Intervention (intervention) and Delayed Intervention (control) groups. We compared the difference in the percentage of residents designated mostly and a great deal on Limited English Proficiency and Informed Consent OSCE."||||0.2665
72386861|NCT03576495|144281885|SUPERIORITY||difference in the percentage|6.2||||0.0001|TWO_SIDED||||||Chi-squared|||"We conducted a superiority statistical test to assess if residents' OSCE performance improved after exposure to the PACTS curriculum. OSCE performance was compared at time Period 2 between the Early Intervention (intervention) and Delayed Intervention (control) groups. We compared the difference in the percentage of residents designated mostly and a great deal on Trust and Pain."||||0.0001
72439267|NCT02299375|144392633|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.073||||0.138|TWO_SIDED|95.0|-0.024|0.169||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FVC Pre-dose, Week 8|||0.169|-0.024|0.138
72495520|NCT01846455|144520385|SUPERIORITY_OR_OTHER||ratio of parameter means, %|79.3|||||TWO_SIDED|90.0|40.03|157.12||||||Naloxone||157.12|40.03|
72439268|NCT02299375|144392633|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.012||||0.813|TWO_SIDED|95.0|-0.111|0.087||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FVC Pre-dose, Week 12|||0.087|-0.111|0.813
72439269|NCT02299375|144392633|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.073||||0.172|TWO_SIDED|95.0|-0.032|0.177||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FVC Pre-dose, Week 18|||0.177|-0.032|0.172
72439270|NCT02299375|144392633|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.067||||0.242|TWO_SIDED|95.0|-0.045|0.18||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FVC Pre-dose, Week 26|||0.180|-0.045|0.242
72439271|NCT02299375|144392633|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.082||||0.267|TWO_SIDED|95.0|-0.063|0.228||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FVC Pre-dose, Week 39|||0.228|-0.063|0.267
72439272|NCT02299375|144392633|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.083||||0.471|TWO_SIDED|95.0|-0.143|0.309||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FVC Pre-dose, Week 52|||0.309|-0.143|0.471
72439273|NCT02299375|144392633|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.045||||0.315|TWO_SIDED|95.0|-0.043|0.132||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FVC Post-dose, Week 2|||0.132|-0.043|0.315
72439274|NCT02299375|144392633|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.054||||0.143|TWO_SIDED|95.0|-0.018|0.126||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FVC Post-dose, Week 4|||0.126|-0.018|0.143
72439275|NCT02299375|144392633|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.072||||0.111|TWO_SIDED|95.0|-0.017|0.16||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FVC Post-dose, Week 8|||0.160|-0.017|0.111
72439276|NCT02299375|144392633|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.012||||0.783|TWO_SIDED|95.0|-0.075|0.1||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FVC Post-dose, Week 12|||0.100|-0.075|0.783
72439277|NCT02299375|144392633|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.059||||0.283|TWO_SIDED|95.0|-0.049|0.167||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FVC Post-dose, Week 18|||0.167|-0.049|0.283
72495521|NCT01846455|144520385|SUPERIORITY_OR_OTHER||ratio of parameter means, %|317.58|||||TWO_SIDED|90.0|164.93|611.54||||||Naloxone||611.54|164.93|
72495522|NCT01846455|144520385|SUPERIORITY_OR_OTHER||ratio of parameter means, %|1401.85|||||TWO_SIDED|90.0|707.55|2777.46||||||Naloxone||2777.46|707.55|
72558868|NCT01243151|144647846|SUPERIORITY_OR_OTHER||LS Mean Difference|-49.67|STANDARD_ERROR_OF_MEAN|5.498|<|0.0001|TWO_SIDED|95.0|-60.7|-38.64|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-38.64|-60.70|<0.0001
72558869|NCT01243151|144647846|SUPERIORITY_OR_OTHER||LS Mean Difference|-53.92|STANDARD_ERROR_OF_MEAN|5.592|<|0.0001|TWO_SIDED|95.0|-65.14|-42.7|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-42.70|-65.14|<0.0001
72439278|NCT02299375|144392633|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.138||||0.038|TWO_SIDED|95.0|0.008|0.267||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FVC Post-dose, Week 26|||0.267|0.008|0.038
72439279|NCT02299375|144392633|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.048||||0.467|TWO_SIDED|95.0|-0.083|0.18||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FVC Post-dose, Week 39|||0.180|-0.083|0.467
72439280|NCT02299375|144392633|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.042||||0.64|TWO_SIDED|95.0|-0.138|0.222||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FVC Post-dose, Week 52|||0.222|-0.138|0.640
72495523|NCT01846455|144520385|SUPERIORITY_OR_OTHER||ratio of parameter means, %|105.78|||||TWO_SIDED|90.0|53.39|209.59||||||Naloxone||209.59|53.39|
72495524|NCT01846455|144520385|SUPERIORITY_OR_OTHER||ratio of parameter means, %|74.97|||||TWO_SIDED|90.0|36.09|155.71||||||Naloxone||155.71|36.09|
72495525|NCT01846455|144520385|SUPERIORITY_OR_OTHER||ratio of parameter means, %|300.22|||||TWO_SIDED|90.0|148.44|607.21||||||Naloxone||607.21|148.44|
72495526|NCT01846455|144520385|SUPERIORITY_OR_OTHER||ratio of parameter means, %|1325.22|||||TWO_SIDED|90.0|638.03|2752.55||||||Naloxone||2752.55|638.03|
72495527|NCT01846455|144520385|SUPERIORITY_OR_OTHER||ratio of parameter means, %|85.87|||||TWO_SIDED|90.0|66.06|111.61||||||Naloxone-3-β-D-Glucuronide||111.61|66.06|
72495528|NCT01846455|144520385|SUPERIORITY_OR_OTHER||ratio of parameter means, %|123.77|||||TWO_SIDED|90.0|96.27|159.13||||||Naloxone-3-β-D-Glucuronide||159.13|96.27|
72495529|NCT01846455|144520385|SUPERIORITY_OR_OTHER||ratio of parameter means, %|91.26|||||TWO_SIDED|90.0|70.21|118.62||||||Naloxone-3-β-D-Glucuronide||118.62|70.21|
72439281|NCT02299375|144392634|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.6||||0.661|TWO_SIDED|95.0|-2.08|3.27||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||PP FVC, Week 2|||3.27|-2.08|0.661
72439282|NCT02299375|144392634|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.44||||0.074|TWO_SIDED|95.0|-0.24|5.12||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||PP FVC, Week 6|||5.12|-0.24|0.074
72439283|NCT02299375|144392634|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.52||||0.21|TWO_SIDED|95.0|-1.43|6.46||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||PP FVC, Week 8|||6.46|-1.43|0.210
72439284|NCT02299375|144392634|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.14||||0.933|TWO_SIDED|95.0|-3.4|3.12||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||PP FVC, Week 12|||3.12|-3.40|0.933
72439285|NCT02299375|144392634|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.7||||0.091|TWO_SIDED|95.0|-0.43|5.82||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||PP FVC, Week 18|||5.82|-0.43|0.091
72495530|NCT01846455|144520385|SUPERIORITY_OR_OTHER||ratio of parameter means, %|84.78|||||TWO_SIDED|90.0|65.23|110.2||||||Naloxone-3-β-D-Glucuronide||110.20|65.23|
72439286|NCT02299375|144392634|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.69||||0.018|TWO_SIDED|95.0|0.82|8.56||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||PP FVC, Week 26|||8.56|0.82|0.018
72495531|NCT01846455|144520385|SUPERIORITY_OR_OTHER||ratio of parameter means, %|101.28|||||TWO_SIDED|90.0|76.52|134.06||||||Naloxone-3-β-D-Glucuronide||134.06|76.52|
72495532|NCT01846455|144520385|SUPERIORITY_OR_OTHER||ratio of parameter means, %|145.99|||||TWO_SIDED|90.0|111.43|191.26||||||Naloxone-3-β-D-Glucuronide||191.26|111.43|
72495533|NCT01846455|144520385|SUPERIORITY_OR_OTHER||ratio of parameter means, %|107.64|||||TWO_SIDED|90.0|81.33|142.47||||||Naloxone-3-β-D-Glucuronide||142.47|81.33|
72495534|NCT01846455|144520386|SUPERIORITY_OR_OTHER||ratio of parameter means, %|120.02|||||TWO_SIDED|90.0|83.35|172.82||||||Buprenorphine||172.82|83.35|
72558870|NCT01243151|144647846|SUPERIORITY_OR_OTHER||LS Mean Difference|-60.6|STANDARD_ERROR_OF_MEAN|5.59|<|0.0001|TWO_SIDED|95.0|-71.81|-49.38|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-49.38|-71.81|<0.0001
72558871|NCT01243151|144647846|SUPERIORITY_OR_OTHER||LS Mean Difference|-57.67|STANDARD_ERROR_OF_MEAN|5.413|<|0.0001|TWO_SIDED|95.0|-68.53|-46.8|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-46.80|-68.53|<0.0001
72495535|NCT01846455|144520386|SUPERIORITY_OR_OTHER||ratio of parameter means, %|107.85|||||TWO_SIDED|90.0|75.85|153.36||||||Buprenorphine||153.36|75.85|
72495536|NCT01846455|144520386|SUPERIORITY_OR_OTHER||ratio of parameter means, %|171.76|||||TWO_SIDED|90.0|117.93|250.15||||||Buprenorphine||250.15|117.93|
72558872|NCT01243151|144647846|SUPERIORITY_OR_OTHER||LS Mean Difference|-44.18|STANDARD_ERROR_OF_MEAN|5.8|<|0.0001|TWO_SIDED|95.0|-55.8|-32.57|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-32.57|-55.80|<0.0001
72558873|NCT01243151|144647846|SUPERIORITY_OR_OTHER||LS Mean Difference|-47.28|STANDARD_ERROR_OF_MEAN|5.881|<|0.0001|TWO_SIDED|95.0|-59.06|-35.5|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-35.50|-59.06|<0.0001
72495537|NCT01846455|144520386|SUPERIORITY_OR_OTHER||ratio of parameter means, %|112.82|||||TWO_SIDED|90.0|77.66|163.91||||||Buprenorphine||163.91|77.66|
72495538|NCT01846455|144520386|SUPERIORITY_OR_OTHER||ratio of parameter means, %|106.38|||||TWO_SIDED|90.0|71.43|158.43||||||Buprenorphine||158.43|71.43|
72495539|NCT01846455|144520386|SUPERIORITY_OR_OTHER||ratio of parameter means, %|95.59|||||TWO_SIDED|90.0|64.36|141.99||||||Buprenorphine||141.99|64.36|
72495540|NCT01846455|144520386|SUPERIORITY_OR_OTHER||ratio of parameter means, %|152.24|||||TWO_SIDED|90.0|103.08|224.83||||||Buprenorphine||224.83|103.08|
72495541|NCT01846455|144520386|SUPERIORITY_OR_OTHER||ratio of parameter means, %|135.17|||||TWO_SIDED|90.0|75.44|242.16||||||Norbuprenorphine||242.16|75.44|
72495542|NCT01846455|144520386|SUPERIORITY_OR_OTHER||ratio of parameter means, %|67.87|||||TWO_SIDED|90.0|38.82|118.68||||||Norbuprenorphine||118.68|38.82|
72495543|NCT01846455|144520386|SUPERIORITY_OR_OTHER||ratio of parameter means, %|48.39|||||TWO_SIDED|90.0|27.01|86.69||||||Norbuprenorphine||86.69|27.01|
72495544|NCT01846455|144520386|SUPERIORITY_OR_OTHER||ratio of parameter means, %|76.59|||||TWO_SIDED|90.0|42.75|137.22||||||Norbuprenorphine||137.22|42.75|
72495545|NCT01846455|144520386|SUPERIORITY_OR_OTHER||ratio of parameter means, %|176.48|||||TWO_SIDED|90.0|94.62|329.17||||||Norbuprenorphine||329.17|94.62|
72495546|NCT01846455|144520386|SUPERIORITY_OR_OTHER||ratio of parameter means, %|88.62|||||TWO_SIDED|90.0|48.6|161.59||||||Norbuprenorphine||161.59|48.60|
72495547|NCT01846455|144520386|SUPERIORITY_OR_OTHER||ratio of parameter means, %|63.17|||||TWO_SIDED|90.0|33.87|117.83||||||Norbuprenorphine||117.83|33.87|
72495548|NCT01846455|144520386|SUPERIORITY_OR_OTHER||ratio of parameter means, %|100.41|||||TWO_SIDED|90.0|51.3|196.53||||||Naloxone||196.53|51.30|
72495549|NCT01846455|144520386|SUPERIORITY_OR_OTHER||ratio of parameter means, %|270.0|||||TWO_SIDED|90.0|141.86|513.9||||||Naloxone||513.90|141.86|
72495550|NCT01846455|144520386|SUPERIORITY_OR_OTHER||ratio of parameter means, %|1129.81|||||TWO_SIDED|90.0|577.22|2211.44||||||Naloxone||2211.44|577.22|
72439287|NCT02299375|144392634|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.3||||0.103|TWO_SIDED|95.0|-0.69|7.29||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||PP FVC, Week 39|||7.29|-0.69|0.103
72439288|NCT02299375|144392634|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.16||||0.448|TWO_SIDED|95.0|-3.5|7.82||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||PP FVC, Week 52|||7.82|-3.50|0.448
72439289|NCT02299375|144392634|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.75||||0.089|TWO_SIDED|95.0|-0.27|3.77||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||PP FEV1, Week 2|||3.77|-0.27|0.089
72495551|NCT01846455|144520386|SUPERIORITY_OR_OTHER||ratio of parameter means, %|126.25|||||TWO_SIDED|90.0|64.5|247.11||||||Naloxone||247.11|64.50|
72495552|NCT01846455|144520386|SUPERIORITY_OR_OTHER||ratio of parameter means, %|79.53|||||TWO_SIDED|90.0|38.79|163.06||||||Naloxone||163.06|38.79|
72495553|NCT01846455|144520386|SUPERIORITY_OR_OTHER||ratio of parameter means, %|213.86|||||TWO_SIDED|90.0|107.07|427.17||||||Naloxone||427.17|107.07|
72495554|NCT01846455|144520386|SUPERIORITY_OR_OTHER||ratio of parameter means, %|894.91|||||TWO_SIDED|90.0|436.49|1834.8||||||Naloxone||1834.80|436.49|
72495555|NCT01846455|144520386|SUPERIORITY_OR_OTHER||ratio of parameter means, %|111.03|||||TWO_SIDED|90.0|85.94|143.44||||||Naloxone-3-β-D-Glucuronide||143.44|85.94|
72495556|NCT01846455|144520386|SUPERIORITY_OR_OTHER||ratio of parameter means, %|111.22|||||TWO_SIDED|90.0|87.02|142.16||||||Naloxone-3-β-D-Glucuronide||142.16|87.02|
72495557|NCT01846455|144520386|SUPERIORITY_OR_OTHER||ratio of parameter means, %|83.09|||||TWO_SIDED|90.0|64.32|107.35||||||Naloxone-3-β-D-Glucuronide||107.35|64.32|
72618936|NCT01260324|144768306|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.64|||||TWO_SIDED|95.0|1.08|2.49|||||Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.|Odds ratio Ill defined and unknown causes of morbidity and mortality||2.49|1.08|
72618937|NCT01260324|144768307|SUPERIORITY_OR_OTHER_LEGACY||Incidence rate per 1000 person-years|0.05|||||TWO_SIDED|95.0|0.03|0.07|||||Standardized to the quintiles of the probability predicted by all the other risk factors of NAION among the Controls.|Incidence rate Recent use||0.07|0.03|
72618938|NCT01260324|144768307|SUPERIORITY_OR_OTHER_LEGACY||Incidence rate per 1000 person-years|0.06|||||TWO_SIDED|95.0|0.04|0.08|||||Standardized to the quintiles of the probability predicted by all the other risk factors of NAION among the Controls.|Incidence rate Any use (includes chronic and non-chronic use)||0.08|0.04|
72618939|NCT01260324|144768307|SUPERIORITY_OR_OTHER_LEGACY||Incidence rate per 1000 person-years|0.05|||||TWO_SIDED|95.0|0.03|0.08|||||Standardized to the quintiles of the probability predicted by all the other risk factors of NAION among the Controls.|Incidence rate Chronic use||0.08|0.03|
72439290|NCT02299375|144392634|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.76||||0.095|TWO_SIDED|95.0|-0.31|3.84||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||PP FEV1, Week 4|||3.84|-0.31|0.095
72495558|NCT01846455|144520386|SUPERIORITY_OR_OTHER||ratio of parameter means, %|83.66|||||TWO_SIDED|90.0|64.75|108.08||||||Naloxone-3-β-D-Glucuronide||108.08|64.75|
72495559|NCT01846455|144520386|SUPERIORITY_OR_OTHER||ratio of parameter means, %|132.72|||||TWO_SIDED|90.0|100.93|174.53||||||Naloxone-3-β-D-Glucuronide||174.53|100.93|
72495560|NCT01846455|144520386|SUPERIORITY_OR_OTHER||ratio of parameter means, %|132.95|||||TWO_SIDED|90.0|102.12|173.1||||||Naloxone-3-β-D-Glucuronide||173.10|102.12|
72495561|NCT01846455|144520386|SUPERIORITY_OR_OTHER||ratio of parameter means, %|99.33|||||TWO_SIDED|90.0|75.54|130.61||||||Naloxone-3-β-D-Glucuronide||130.61|75.54|
72495562|NCT01846455|144520387|SUPERIORITY_OR_OTHER||ratio of parameter means, %|125.19|||||TWO_SIDED|90.0|79.46|197.24||||||Buprenorphine||197.24|79.46|
72495563|NCT01846455|144520387|SUPERIORITY_OR_OTHER||ratio of parameter means, %|220.97|||||TWO_SIDED|90.0|135.33|360.81||||||Buprenorphine||360.81|135.33|
72495564|NCT01846455|144520387|SUPERIORITY_OR_OTHER||ratio of parameter means, %|249.28|||||TWO_SIDED|90.0|162.19|383.14||||||Buprenorphine||383.14|162.19|
72495565|NCT01846455|144520387|SUPERIORITY_OR_OTHER||ratio of parameter means, %|94.44|||||TWO_SIDED|90.0|56.44|158.02||||||Buprenorphine||158.02|56.44|
72495566|NCT01846455|144520387|SUPERIORITY_OR_OTHER||ratio of parameter means, %|132.57|||||TWO_SIDED|90.0|78.86|222.84||||||Buprenorphine||222.84|78.86|
72495567|NCT01846455|144520387|SUPERIORITY_OR_OTHER||ratio of parameter means, %|233.99|||||TWO_SIDED|90.0|135.63|403.68||||||Buprenorphine||403.68|135.63|
72495568|NCT01846455|144520387|SUPERIORITY_OR_OTHER||ratio of parameter means, %|263.97|||||TWO_SIDED|90.0|155.52|448.03||||||Buprenorphine||448.03|155.52|
72495569|NCT01846455|144520387|SUPERIORITY_OR_OTHER||ratio of parameter means, %|159.38|||||TWO_SIDED|90.0|78.21|324.79||||||Norbuprenorphine||324.79|78.21|
72495570|NCT01846455|144520387|SUPERIORITY_OR_OTHER||ratio of parameter means, %|106.93|||||TWO_SIDED|90.0|52.47|217.91||||||Norbuprenorphine||217.91|52.47|
72495571|NCT01846455|144520387|SUPERIORITY_OR_OTHER||ratio of parameter means, %|87.1|||||TWO_SIDED|90.0|42.74|177.5||||||Norbuprenorphine||177.50|42.74|
72495572|NCT01846455|144520387|SUPERIORITY_OR_OTHER||ratio of parameter means, %|182.98|||||TWO_SIDED|90.0|89.79|372.89||||||Norbuprenorphine||372.89|89.79|
72495573|NCT01846455|144520387|SUPERIORITY_OR_OTHER||ratio of parameter means, %|122.77|||||TWO_SIDED|90.0|60.24|250.19||||||Norbuprenorphine||250.19|60.24|
72495574|NCT01846455|144520387|SUPERIORITY_OR_OTHER||ratio of parameter means, %|69.12|||||TWO_SIDED|90.0|33.45|142.82||||||Naloxone||142.82|33.45|
72495575|NCT01846455|144520387|SUPERIORITY_OR_OTHER||ratio of parameter means, %|282.17|||||TWO_SIDED|90.0|141.59|562.3||||||Naloxone||562.30|141.59|
72495576|NCT01846455|144520387|SUPERIORITY_OR_OTHER||ratio of parameter means, %|1497.7|||||TWO_SIDED|90.0|724.85|3094.59||||||Naloxone||3094.59|724.85|
72495577|NCT01846455|144520387|SUPERIORITY_OR_OTHER||ratio of parameter means, %|87.64|||||TWO_SIDED|90.0|40.3|190.59||||||Naloxone||190.59|40.30|
72495578|NCT01846455|144520387|SUPERIORITY_OR_OTHER||ratio of parameter means, %|78.86|||||TWO_SIDED|90.0|34.34|181.12||||||Naloxone||181.12|34.34|
72618940|NCT01260324|144768307|SUPERIORITY_OR_OTHER_LEGACY||Incidence rate per 1000 person-years|0.06|||||TWO_SIDED|95.0|0.03|0.11|||||Standardized to the quintiles of the probability predicted by all the other risk factors of NAION among the Controls.|Incidence rate Non-chronic use||0.11|0.03|
72439291|NCT02299375|144392634|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.19||||0.073|TWO_SIDED|95.0|-0.2|4.58||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||PP FEV1, Week 8|||4.58|-0.20|0.073
72439292|NCT02299375|144392634|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.22||||0.853|TWO_SIDED|95.0|-2.08|2.51||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||PP FEV1, Week 12|||2.51|-2.08|0.853
72439293|NCT02299375|144392634|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.37||||0.334|TWO_SIDED|95.0|-1.43|4.17||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||PP FEV1, Week 18|||4.17|-1.43|0.334
72439294|NCT02299375|144392634|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.33||||0.017|TWO_SIDED|95.0|0.61|6.05||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||PP FEV1, Week 26|||6.05|0.61|0.017
72439295|NCT02299375|144392634|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.13||||0.077|TWO_SIDED|95.0|-0.34|6.59||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||PP FEV1, Week 39|||6.59|-0.34|0.077
72618941|NCT01260324|144768307|SUPERIORITY_OR_OTHER_LEGACY||Incidence rate per 1000 person-years|0.09|||||TWO_SIDED|95.0|0.08|0.1|||||Standardized to the quintiles of the probability predicted by all the other risk factors of NAION among the Controls.|Incidence rate Never use||0.10|0.08|
72439296|NCT02299375|144392634|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.34||||0.355|TWO_SIDED|95.0|-2.7|7.38||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||PP FEV1, Week 52|||7.38|-2.70|0.355
72439297|NCT02299375|144392634|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.82||||0.044|TWO_SIDED|95.0|0.08|5.55||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||PP FEV6, Week 2|||5.55|0.08|0.044
72439298|NCT02299375|144392634|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.87||||0.032|TWO_SIDED|95.0|0.25|5.49||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||PP FEV6, Week 4|||5.49|0.25|0.032
72439299|NCT02299375|144392634|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.75||||0.025|TWO_SIDED|95.0|0.49|7.01||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||PP FEV6, Week 8|||7.01|0.49|0.025
72439300|NCT02299375|144392634|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.4||||0.785|TWO_SIDED|95.0|-2.5|3.29||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||PP FEV6, Week 12|||3.29|-2.50|0.785
72439301|NCT02299375|144392634|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.34||||0.052|TWO_SIDED|95.0|-0.03|6.7||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||PP FEV6, Week 18|||6.70|-0.03|0.052
72439302|NCT02299375|144392634|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.53||||0.041|TWO_SIDED|95.0|0.14|6.92||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||PP FEV6, Week 26|||6.92|0.14|0.041
72439303|NCT02299375|144392634|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.19||||0.043|TWO_SIDED|95.0|0.13|8.25||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||PP FEV6, Week 39|||8.25|0.13|0.043
72439304|NCT02299375|144392634|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.67||||0.562|TWO_SIDED|95.0|-6.58|11.92||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||PP FEV6, Week 52|||11.92|-6.58|0.562
72439305|NCT02299375|144392634|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.21||||0.746|TWO_SIDED|95.0|-1.09|1.52||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||Pre-dose FEV1/FVC, Week 2|||1.52|-1.09|0.746
72495579|NCT01846455|144520387|SUPERIORITY_OR_OTHER||ratio of parameter means, %|321.94|||||TWO_SIDED|90.0|144.65|716.52||||||Naloxone||716.52|144.65|
72618942|NCT02596893|144768311|SUPERIORITY||Stratified Difference|-2.9||||0.2523|TWO_SIDED|95.0|-9.7|3.9|||Cochran-Mantel-Haenszel||The weighted average of the treatment differences across the strata with the CMH weights.|||3.9|-9.7|0.2523
72618943|NCT02596893|144768311|SUPERIORITY||Slope|4.8||||0.1626|TWO_SIDED|95.0|-3.0|11.8|||Cochran-Mantel-Haenszel||The weighted average of the treatment differences across the strata with the CMH weights.|||11.8|-3.0|0.1626
72618944|NCT02596893|144768311|SUPERIORITY||Stratified Difference|-2.1||||0.442|TWO_SIDED|95.0|-9.1|5.3|||Cochran-Mantel-Haenszel||The weighted average of the treatment differences across the strata with the CMH weights.|||5.3|-9.1|0.4420
72439306|NCT02299375|144392634|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.13||||0.878|TWO_SIDED|95.0|-1.53|1.79||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||Pre-dose FEV1/FVC, Week 4|||1.79|-1.53|0.878
72439307|NCT02299375|144392634|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.35||||0.644|TWO_SIDED|95.0|-1.15|1.85||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||Pre-dose FEV1/FVC, Week 8|||1.85|-1.15|0.644
72439308|NCT02299375|144392634|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.29||||0.715|TWO_SIDED|95.0|-1.86|1.28||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||Pre-dose FEV1/FVC, Week 12|||1.28|-1.86|0.715
72439309|NCT02299375|144392634|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.24||||0.803|TWO_SIDED|95.0|-1.62|2.1||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||Pre-dose FEV1/FVC, Week 18|||2.10|-1.62|0.803
72439310|NCT02299375|144392634|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.32||||0.184|TWO_SIDED|95.0|-0.63|3.27||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||Pre-dose FEV1/FVC, Week 26|||3.27|-0.63|0.184
72439311|NCT02299375|144392634|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.05||||0.102|TWO_SIDED|95.0|-0.42|4.52||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||Pre-dose FEV1/FVC, Week 39|||4.52|-0.42|0.102
72439312|NCT02299375|144392634|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.44||||0.383|TWO_SIDED|95.0|-1.85|4.73||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||Pre-dose FEV1/FVC, Week 52|||4.73|-1.85|0.383
72439313|NCT02299375|144392634|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.43||||0.607|TWO_SIDED|95.0|-1.2|2.06||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||Post-dose FEV1/FVC, Week 2|||2.06|-1.20|0.607
72439314|NCT02299375|144392634|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.67||||0.348|TWO_SIDED|95.0|-0.74|2.08||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||Post-dose FEV1/FVC, Week 4|||2.08|-0.74|0.348
72439315|NCT02299375|144392634|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.17||||0.826|TWO_SIDED|95.0|-1.32|1.65||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||Post-dose FEV1/FVC, Week 8|||1.65|-1.32|0.826
72439316|NCT02299375|144392634|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.46||||0.588|TWO_SIDED|95.0|-2.13|1.21||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||Post-dose FEV1/FVC, Week 12|||1.21|-2.13|0.588
72439317|NCT02299375|144392634|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.41||||0.585|TWO_SIDED|95.0|-1.08|1.91||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||Post-dose FEV1/FVC, Week 18|||1.91|-1.08|0.585
72439318|NCT02299375|144392634|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.82||||0.231|TWO_SIDED|95.0|-2.48|10.12||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||Post-dose FEV1/FVC, Week 26|||10.12|-2.48|0.231
72439319|NCT02299375|144392634|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.45||||0.24|TWO_SIDED|95.0|-0.99|3.89||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||Post-dose FEV1/FVC, Week 39|||3.89|-0.99|0.240
72439320|NCT02299375|144392634|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.17||||0.517|TWO_SIDED|95.0|-2.49|4.84||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||Post-dose FEV1/FVC, Week 52|||4.84|-2.49|0.517
72439321|NCT02299375|144392641|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.67||||0.706|TWO_SIDED|95.0|-4.2|2.85||Analysis was performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment by visit and Baseline by visit interactions.|Mixed Models Analysis||SGRQ Total, Week 12|||2.85|-4.20|0.706
72439322|NCT02299375|144392641|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.89||||0.694|TWO_SIDED|95.0|-3.58|5.36||Analysis was performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment by visit and Baseline by visit interactions.|Mixed Models Analysis||SGRQ Total, Week 26|||5.36|-3.58|0.694
72495580|NCT01846455|144520387|SUPERIORITY_OR_OTHER||ratio of parameter means, %|1708.83|||||TWO_SIDED|90.0|744.08|3924.47||||||Naloxone||3924.47|744.08|
72495581|NCT01846455|144520387|SUPERIORITY_OR_OTHER||ratio of parameter means, %|84.2|||||TWO_SIDED|90.0|60.92|116.38||||||Naloxone-3-β-D-Glucuronide||116.38|60.92|
72618945|NCT02596893|144768312|SUPERIORITY||Stratified Difference|-2.6||||0.1799|TWO_SIDED|95.0|-9.5|5.0|||Cochran-Mantel-Haenszel||The weighted average of the treatment differences across the strata with the CMH weights.|||5.0|-9.5|0.1799
72386862|NCT03576495|144281886|SUPERIORITY||absolute difference between percentage|3.19||||0.5079|TWO_SIDED||||||Chi-squared|||"We conducted a superiority statistical test to assess if patient satisfaction improved after resident exposure to the PACTS curriculum. For purposes of measuring an effect of the PACTS curriculum, patient satisfaction was compared at time Period 2 between the Early Intervention (intervention) and Delayed Intervention (control) groups. We compared the difference in proportion of patients who reported agree and strongly agree for satisfaction as it relates to trust at time period 2."||||0.5079
72386863|NCT03576495|144281886|SUPERIORITY||absolute difference between percentage|1.92||||0.1571|TWO_SIDED||||||Chi-squared|||"We conducted a superiority statistical test to assess if patient satisfaction improved after resident exposure to the PACTS curriculum. For purposes of measuring an effect of the curriculum, patient satisfaction was compared at Period 2 between the Early Intervention (intervention) and Delayed Intervention (control) groups. We compared the difference in proportion of patients who reported agree and strongly agree for satisfaction as it relates to limited English proficiency at period 2."||||0.1571
72618946|NCT02596893|144768312|SUPERIORITY||Stratified Difference|-2.4||||0.2309|TWO_SIDED|95.0|-9.4|4.9|||Cochran-Mantel-Haenszel||The weighted average of the treatment differences across the strata with the CMH weights.|||4.9|-9.4|0.2309
72618947|NCT02596893|144768312|SUPERIORITY||Stratified Difference|-2.1||||0.3264|TWO_SIDED|95.0|-9.1|4.6|||Cochran-Mantel-Haenszel||The weighted average of the treatment differences across the strata with the CMH weights.|||4.6|-9.1|0.3264
72439323|NCT02299375|144392641|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.83||||0.382|TWO_SIDED|95.0|-9.23|3.58||Analysis was performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment by visit and Baseline by visit interactions.|Mixed Models Analysis||SGRQ Total, Week 39|||3.58|-9.23|0.382
72439324|NCT02299375|144392641|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.49||||0.903|TWO_SIDED|95.0|-8.54|7.57||Analysis was performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment by visit and Baseline by visit interactions.|Mixed Models Analysis||SGRQ Total, Week 52|||7.57|-8.54|0.903
72439325|NCT02299375|144392641|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.67||||0.481|TWO_SIDED|95.0|-6.33|2.99||Analysis was performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment by visit and Baseline by visit interactions.|Mixed Models Analysis||SGRQ Symptoms, Week 12|||2.99|-6.33|0.481
72439326|NCT02299375|144392641|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.73||||0.793|TWO_SIDED|95.0|-4.79|6.25||Analysis was performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment by visit and Baseline by visit interactions.|Mixed Models Analysis||SGRQ Symptoms, Week 26|||6.25|-4.79|0.793
72439327|NCT02299375|144392641|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.6||||0.421|TWO_SIDED|95.0|-12.45|5.26||Analysis was performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment by visit and Baseline by visit interactions.|Mixed Models Analysis||SGRQ Symptoms, Week 39|||5.26|-12.45|0.421
72439328|NCT02299375|144392641|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-7.98||||0.162|TWO_SIDED|95.0|-19.35|3.4||Analysis was performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment by visit and Baseline by visit interactions.|Mixed Models Analysis||SGRQ Symptoms, Week 52|||3.40|-19.35|0.162
72439329|NCT02299375|144392641|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.23||||0.592|TWO_SIDED|95.0|-3.31|5.78||Analysis was performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment by visit and Baseline by visit interactions.|Mixed Models Analysis||SGRQ Activity, Week 12|||5.78|-3.31|0.592
72439330|NCT02299375|144392641|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.03||||0.704|TWO_SIDED|95.0|-4.31|6.36||Analysis was performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment by visit and Baseline by visit interactions.|Mixed Models Analysis||SGRQ Activity, Week 26|||6.36|-4.31|0.704
72439331|NCT02299375|144392641|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.41||||0.546|TWO_SIDED|95.0|-10.32|5.5||Analysis was performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment by visit and Baseline by visit interactions.|Mixed Models Analysis||SGRQ Activity, Week 39|||5.50|-10.32|0.546
72495582|NCT01846455|144520387|SUPERIORITY_OR_OTHER||ratio of parameter means, %|110.98|||||TWO_SIDED|90.0|82.02|150.17||||||Naloxone-3-β-D-Glucuronide||150.17|82.02|
72439332|NCT02299375|144392641|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.39||||0.35|TWO_SIDED|95.0|-5.06|13.84||Analysis was performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment by visit and Baseline by visit interactions.|Mixed Models Analysis||SGRQ Activity, Week 52|||13.84|-5.06|0.350
72439333|NCT02299375|144392641|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.69||||0.411|TWO_SIDED|95.0|-5.75|2.37||Analysis was performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment by visit and Baseline by visit interactions.|Mixed Models Analysis||SGRQ Impact, Week 12|||2.37|-5.75|0.411
72439334|NCT02299375|144392641|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.35||||0.896|TWO_SIDED|95.0|-5.67|4.97||Analysis was performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment by visit and Baseline by visit interactions.|Mixed Models Analysis||SGRQ Impact, Week 26|||4.97|-5.67|0.896
72495583|NCT01846455|144520387|SUPERIORITY_OR_OTHER||ratio of parameter means, %|81.97|||||TWO_SIDED|90.0|60.03|111.92||||||Naloxone-3-β-D-Glucuronide||111.92|60.03|
72495584|NCT01846455|144520387|SUPERIORITY_OR_OTHER||ratio of parameter means, %|82.78|||||TWO_SIDED|90.0|59.89|114.42||||||Naloxone-3-β-D-Glucuronide||114.42|59.89|
72495585|NCT01846455|144520387|SUPERIORITY_OR_OTHER||ratio of parameter means, %|101.71|||||TWO_SIDED|90.0|74.96|138.0||||||Naloxone-3-β-D-Glucuronide||138.00|74.96|
72618948|NCT02596893|144768313|SUPERIORITY||Stratified Difference|-11.7||||0.0299|TWO_SIDED|95.0|-22.0|-1.1|||Cochran-Mantel-Haenszel||The weighted average of the treatment differences across the strata with the CMH weights.|||-1.1|-22.0|0.0299
72495586|NCT01846455|144520387|SUPERIORITY_OR_OTHER||ratio of parameter means, %|134.06|||||TWO_SIDED|90.0|101.07|177.82||||||Naloxone-3-β-D-Glucuronide||177.82|101.07|
72495587|NCT01846455|144520387|SUPERIORITY_OR_OTHER||ratio of parameter means, %|99.02|||||TWO_SIDED|90.0|73.93|132.61||||||Naloxone-3-β-D-Glucuronide||132.61|73.93|
72495588|NCT00847587|144520399|NON_INFERIORITY_OR_EQUIVALENCE|A noninferiority margin of 8 additional hours was chosen to be clinically relevant, as many common medical interventions (such as epidural anesthesia, cesarean delivery, labor induction, and general stress) have been reported to delay time to lactogenesis stage II by up to 12 hours.|Mean Difference (Final Values)|0.03|STANDARD_DEVIATION|120.0|<|0.05|TWO_SIDED|95.0|-10.6|7.7|||t-test, 2 sided|||It was assumed that both groups would have a mean of 54 hours to lactogenesis with a common standard deviation of 12 hours based on previous reports of lactogenesis in women with uncomplicated vaginal deliveries. Setting the noninferiority margin at 8 additional hours, using an alpha 0.05 level comparison, to achieve 80% power a sample size of n=34 evaluable subjects was required in each group. The calculation was performed using N Solution 2007 Professional Software.||7.7|-10.6|<0.05
72495589|NCT00847587|144520400|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.61|STANDARD_DEVIATION|1.8|<|0.05|TWO_SIDED|95.0|-1.3|2.5|||t-test, 2 sided|||||2.5|-1.3|<0.05
72495590|NCT00454779|144520401|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.629||||0.051|TWO_SIDED|95.0|0.395|1.002|||Regression, Cox|Stratified by IVRS randomization factors|Hazard ratio is presented as panitumumab plus chemotherapy:chemotherapy alone.|||1.002|0.395|0.051
72495591|NCT00454779|144520401|SUPERIORITY_OR_OTHER|||||||0.048|||||||Log Rank|Stratified by IVRS randomization factors||||||0.048
72495592|NCT00454779|144520402|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.23|||||TWO_SIDED|95.0|-11.67|24.12|||||With Mantel-Haenszel weights within strata defined by randomization factors recorded in the IVRS|||24.12|-11.67|
72495593|NCT00454779|144520402|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.37||||||95.0|0.57|3.33|||||Calculated from a logistic regression model with treatment indicator and randomization factors (recorded on the CRF) as covariates|||3.33|0.57|
72558874|NCT01243151|144647846|SUPERIORITY_OR_OTHER||LS Mean Difference|-57.73|STANDARD_ERROR_OF_MEAN|5.891|<|0.0001|TWO_SIDED|95.0|-69.53|-45.94|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-45.94|-69.53|<0.0001
72618949|NCT02596893|144768313|SUPERIORITY||Stratified difference|-9.9||||0.0582|TWO_SIDED|95.0|-20.3|0.7|||Cochran-Mantel-Haenszel||The weighted average of the treatment differences across the strata with the CMH weights.|||0.7|-20.3|0.0582
72386864|NCT03576495|144281886|SUPERIORITY||absolute difference between percentage|4.76||||0.0001|TWO_SIDED||||||Chi-squared|||"We conducted a superiority statistical test to assess if patient satisfaction improved after resident exposure to the PACTS curriculum. For purposes of measuring an effect of the PACTS curriculum, patient satisfaction was compared at time Period 2 between the Early Intervention (intervention) and Delayed Intervention (control) groups. We compared the difference in proportion of patients who reported agree and strongly agree for satisfaction as it relates to consent at time period 2."||||0.0001
72386865|NCT03576495|144281886|SUPERIORITY||absolute difference between percentage|0.19||||0.2956|TWO_SIDED||||||Chi-squared|||"We conducted a superiority statistical test to assess if patient satisfaction improved after resident exposure to the PACTS curriculum. For purposes of measuring an effect of the PACTS curriculum, patient satisfaction was compared at time Period 2 between the Early Intervention (intervention) and Delayed Intervention (control) groups. We compared the difference in proportion of patients who reported agree and strongly agree for satisfaction as it relates to pain at time period 2."||||0.2956
72386866|NCT03576495|144281887|SUPERIORITY||Cox Proportional Hazard|5.31||||0.0028|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||We used Cox Proportional Hazard to assess time to discharge, with 5.31 days as the estimated value for the difference between the two groups.|"We conducted a superiority statistical test to assess if patients length of stay improved after resident exposure to the PACTS curriculum. Patient length of stay was compared at time Period 2 between the Early Intervention (intervention) and Delayed Intervention (control) groups to measure an effect of the PACTS intervention."||||0.0028
72495594|NCT00454779|144520403|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.78|||||TWO_SIDED|95.0|-8.29|23.85|||||With Mantel-Haenszel weights within strata defined by randomization factors recorded in the IVRS|||23.85|-8.29|
72495595|NCT00454779|144520403|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.76||||||95.0|0.62|5.26|||||Calculated from a logistic regression model with treatment indicator and randomization factors (recorded on the CRF) as covariates|||5.26|0.62|
72495596|NCT00454779|144520406|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.103||||0.663|TWO_SIDED|95.0|0.709|1.717|||Regression, Cox|Stratified by IVRS randomization factors|Hazard ratio is presented as panitumumab plus chemotherapy:chemotherapy alone|||1.717|0.709|0.663
72495597|NCT00454779|144520406|SUPERIORITY_OR_OTHER|||||||0.666|||||||Log Rank|Stratified by IVRS randomization factors||||||0.666
72495598|NCT05425563|144520413|OTHER||Slope|8.3269|STANDARD_ERROR_OF_MEAN|0.8792|<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||< .001
72495599|NCT05425563|144520414|OTHER||Slope|8.0809|STANDARD_ERROR_OF_MEAN|0.5414|<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||< .001
72495600|NCT05425563|144520415|OTHER||Slope|8.121|STANDARD_ERROR_OF_MEAN|0.481|<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||< .001
72495601|NCT05425563|144520422|OTHER||Slope|34.613|STANDARD_ERROR_OF_MEAN|0.602|<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||< .001
72495602|NCT05425563|144520423|OTHER||Slope|33.9754|STANDARD_ERROR_OF_MEAN|0.426||0.001|TWO_SIDED||||||Mixed Models Analysis|||||||.001
72495603|NCT05425563|144520424|OTHER||Slope|31.63|STANDARD_ERROR_OF_MEAN|0.422|<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||< .001
72495604|NCT01087541|144520438|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.5|STANDARD_DEVIATION|0.5|<|0.01||95.0|0.0|1.0|||t-test, 2 sided|||||1|0|<0.01
72495605|NCT01087541|144520440|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.0|STANDARD_DEVIATION|5.0|<|0.001|TWO_SIDED|95.0|2.0|15.0|||t-test, 2 sided|||||15|2|<0.001
72495606|NCT03222427|144520441|OTHER||Ratio of Geometric Least Squares Means|0.952|||||TWO_SIDED|90.0|0.769|1.18||||||||1.18|0.769|
72495607|NCT01970176|144520443|SUPERIORITY|||||||0.8|||||||Wilcoxon (Mann-Whitney)|||||||0.8
72495608|NCT01970176|144520444|SUPERIORITY|||||||0.25|||||||Wilcoxon (Mann-Whitney)|||||||0.25
72495609|NCT01970176|144520445|SUPERIORITY|||||||0.32|||||||Wilcoxon (Mann-Whitney)|||||||0.32
72618950|NCT02596893|144768313|SUPERIORITY||Stratified difference|-9.7||||0.0741|TWO_SIDED|95.0|-20.1|1.0|||Cochran-Mantel-Haenszel||The weighted average of the treatment differences across the strata with the Cochran-Mantel-Haenszel (CMH) weights.|||1.0|-20.1|0.0741
72618951|NCT02596893|144768314|SUPERIORITY||Stratified difference|-5.8||||0.2493|TWO_SIDED|95.0|-15.5|4.0|||Cochran-Mantel-Haenszel||The weighted average of the treatment differences across the strata with the Cochran-Mantel-Haenszel (CMH) weights.|||4.0|-15.5|0.2493
72618952|NCT02596893|144768314|SUPERIORITY||Stratified difference|-1.8||||0.716|TWO_SIDED|95.0|-11.8|8.2|||Cochran-Mantel-Haenszel||The weighted average of the treatment differences across the strata with the Cochran-Mantel-Haenszel (CMH) weights.|||8.2|-11.8|0.7160
72618953|NCT02596893|144768314|SUPERIORITY||Stratified difference|-5.8||||0.2452|TWO_SIDED|95.0|-15.5|4.1|||Cochran-Mantel-Haenszel||The weighted average of the treatment differences across the strata with the Cochran-Mantel-Haenszel (CMH) weights.|||4.1|-15.5|0.2452
72618954|NCT02596893|144768315|SUPERIORITY||Stratified difference|-1.3||||0.7541|TWO_SIDED|95.0|-9.8|7.1|||Cochran-Mantel-Haenszel||The weighted average of the treatment differences across the strata with the Cochran-Mantel-Haenszel (CMH) weights.|||7.1|-9.8|0.7541
72618955|NCT02596893|144768315|SUPERIORITY||Stratified difference|-3.7||||0.3784|TWO_SIDED|95.0|-12.0|4.6|||Cochran-Mantel-Haenszel||The weighted average of the treatment differences across the strata with the Cochran-Mantel-Haenszel (CMH) weights.|||4.6|-12.0|0.3784
72618956|NCT02596893|144768315|SUPERIORITY||Stratified difference|-4.4||||0.2865|TWO_SIDED|95.0|-12.6|3.8|||Cochran-Mantel-Haenszel||The weighted average of the treatment differences across the strata with the Cochran-Mantel-Haenszel (CMH) weights.|||3.8|-12.6|0.2865
72618957|NCT02596893|144768316|SUPERIORITY||Unstratified CMH|-2.2||||0.3572|TWO_SIDED|95.0|-11.3|7.0|||Cochran-Mantel-Haenszel|p-values were based on the unstratified CMH test when 1 and only 1 of the 2 treatment groups being compared had no subjects in a stratum.|The weighted average of the treatment differences across the strata with the CMH weights.|2-sided 95% CI were based on the unstratified Newcombe method.||7.0|-11.3|0.3572
72618958|NCT02596893|144768316|SUPERIORITY||Stratified difference|4.7||||0.2823|TWO_SIDED|95.0|-8.8|18.9|||Cochran-Mantel-Haenszel||The weighted average of the treatment differences across the strata with the CMH weights.|||18.9|-8.8|0.2823
72618959|NCT02596893|144768316|SUPERIORITY||Stratified difference|0.0|||>|0.9999|TWO_SIDED|95.0|-12.8|13.7|||Cochran-Mantel-Haenszel||The weighted average of the treatment differences across the strata with the CMH weights.|||13.7|-12.8|> 0.9999
72618960|NCT02596893|144768317|SUPERIORITY||Stratified difference|-0.5||||0.8031|TWO_SIDED|95.0|-6.7|5.9|||Cochran-Mantel-Haenszel||The weighted average of the treatment differences across the strata with the CMH weights.|||5.9|-6.7|0.8031
72618961|NCT02596893|144768317|SUPERIORITY||Stratified difference|1.4||||0.5583|TWO_SIDED|95.0|-5.1|7.3|||Cochran-Mantel-Haenszel||The weighted average of the treatment differences across the strata with the CMH weights.|||7.3|-5.1|0.5583
72618962|NCT02596893|144768317|SUPERIORITY||Stratified difference|-1.0||||0.6123|TWO_SIDED|95.0|-7.2|6.8|||Cochran-Mantel-Haenszel||||The weighted average of the treatment differences across the strata with the CMH weights.|6.8|-7.2|0.6123
72618963|NCT02596893|144768318|SUPERIORITY||Stratified difference|-10.6||||0.0239|TWO_SIDED|95.0|-19.6|-1.4|||Cochran-Mantel-Haenszel||The weighted average of the treatment differences across the strata with the CMH weights.|||-1.4|-19.6|0.0239
72386867|NCT00579098|144281896|SUPERIORITY_OR_OTHER|||||||0.75||95.0||||A p-value of \< 0.05 was considered statistically significant.|Log Rank|||||||0.75
72386868|NCT00579098|144281897|SUPERIORITY_OR_OTHER|||||||0.37||95.0||||A p-value of \< 0.05 was considered statistically significant.|Log Rank|||||||0.37
72386869|NCT00579098|144281898|SUPERIORITY_OR_OTHER|||||||0.11||95.0||||A p-value of \< 0.05 was considered statistically significant.|t-test, 2 sided|||||||0.11
72386870|NCT00579098|144281899|SUPERIORITY_OR_OTHER|||||||0.53||95.0||||Comparison between treatment groups. A p-value of \< 0.05 was considered statistically significant.|t-test, 2 sided|||||||0.53
72386871|NCT00579098|144281900|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||A p-value of \< 0.05 was considered statistically significant.|t-test, 2 sided|||The change in total cholesterol was compared between treatment groups.||||<0.001
72618964|NCT02596893|144768318|SUPERIORITY||Stratified difference|-1.0||||0.8334|TWO_SIDED|95.0|-10.8|8.7|||Cochran-Mantel-Haenszel||The weighted average of the treatment differences across the strata with the CMH weights.|||8.7|-10.8|0.8334
72618965|NCT02596893|144768318|SUPERIORITY||Stratified difference|-3.9||||0.4383|TWO_SIDED|95.0|-13.5|5.8|||Cochran-Mantel-Haenszel||The weighted average of the treatment differences across the strata with the Cochran-Mantel-Haenszel (CMH) weights.|||5.8|-13.5|0.4383
72618966|NCT02596893|144768319|SUPERIORITY||Stratified difference|-1.6||||0.3573|TWO_SIDED|95.0|-8.3|5.9|||Cochran-Mantel-Haenszel||The weighted average of the treatment differences across the strata with CMH weights.|||5.9|-8.3|0.3573
72618967|NCT02596893|144768319|SUPERIORITY||Stratified difference|-2.0||||0.2221|TWO_SIDED|95.0|-8.7|5.1|||Cochran-Mantel-Haenszel||The weighted average of the treatment differences across the strata with the CMH weights.|||5.1|-8.7|0.2221
72618968|NCT02596893|144768319|SUPERIORITY||Stratified difference|-2.0||||0.2578|TWO_SIDED|95.0|-8.7|5.6|||Cochran-Mantel-Haenszel||The weighted average of the treatment differences across the strata with the CMH weights.|||5.6|-8.7|0.2578
72618969|NCT02596893|144768322|SUPERIORITY||Stratified Difference|0.5||||0.9141|TWO_SIDED|95.0|-8.9|10.0|||Cochran-Mantel-Haenszel||The weighted average of the treatment differences across the strata with the Cochran-Mantel-Haenszel (CMH) weights|||10.0|-8.9|0.9141
72618970|NCT02596893|144768322|SUPERIORITY||Stratified Difference|-3.6||||0.4286|TWO_SIDED|95.0|-12.8|5.6|||Cochran-Mantel-Haenszel||The weighted average of the treatment differences across the strata with the CMH weights.|||5.6|-12.8|0.4286
72618971|NCT02596893|144768322|SUPERIORITY||Stratified Difference|-2.7||||0.5591|TWO_SIDED|95.0|-12.0|6.6|||Cochran-Mantel-Haenszel||The weighted average of the treatment differences across the strata with the CMH weights.|||6.6|-12.0|0.5591
72618972|NCT03052257|144768323|SUPERIORITY||Median Difference (Final Values)|0.23|STANDARD_ERROR_OF_MEAN|0.04|<|0.0001|TWO_SIDED|95.0|0.15|0.3|||Regression, Linear|||||0.30|0.15|<0.0001
72618973|NCT00004228|144768331|SUPERIORITY_OR_OTHER|||||||0.97|TWO_SIDED||||||Regression, Cox|||"A Cox model was used to assess evidence of a difference in event-free survival comparing regimens A1+A2 (A: CCG BFM) to regimens B1+B2 (B: NHL/BFM-95) while adjusting for the other intervention through stratification."||||.97
72495610|NCT03106779|144520446|SUPERIORITY||treatment difference in the MMR rate|12.2||||0.029|TWO_SIDED|95.0|2.19|22.3|||Cochran-Mantel-Haenszel|Stratified by the randomization stratification factor, i.e. cytogenetic response status (MCyR vs no MCyR) at screening||||22.30|2.19|0.029
72495611|NCT02288247|144520461|SUPERIORITY||Hazard Ratio (HR)|0.72||||0.027|TWO_SIDED|95.0|0.53|0.96||From the Cox proportional hazards model with covariates for treatment and disease progression in Period 1 (radiographic, nonradiographic).|Cox proportional hazards model|||||0.96|0.53|0.027
72495612|NCT02288247|144520462|SUPERIORITY||Hazard Ratio (HR)|0.58||||0.002|TWO_SIDED|95.0|0.41|0.82||From the Cox proportional hazards model with covariates for treatment and disease progression in Period 1 (radiographic, nonradiographic).|Cox proportional hazards model|||||0.82|0.41|0.002
72495613|NCT02288247|144520464|SUPERIORITY|||||||0.142||||||From the Cochran-Mantel-Haenszel test stratified by disease progression (radiographic, non-radiographic) in Period 1.|Cochran-Mantel-Haenszel|||||||0.142
72495614|NCT02288247|144520467|SUPERIORITY||Hazard Ratio (HR)|1.0||||0.994|TWO_SIDED|95.0|0.47|2.13||From the Cox proportional hazards model with covariates for treatment and disease progression in Period 1 (radiographic, nonradiographic).|Cox proportional hazards model|||||2.13|0.47|0.994
72495615|NCT02918019|144520515|OTHER||Rate Ratio|0.57||||0.0049|TWO_SIDED|95.0|0.39|0.84|||Poisson regression|||||0.84|0.39|0.0049
72495616|NCT02918019|144520515|OTHER||Rate Ratio|0.78||||0.1838|TWO_SIDED|95.0|0.54|1.12|||Poisson regression|||||1.12|0.54|0.1838
72495617|NCT02918019|144520515|OTHER||Rate Ratio|0.63||||0.0144|TWO_SIDED|95.0|0.44|0.91|||Poisson regression|||||0.91|0.44|0.0144
72558875|NCT01243151|144647846|SUPERIORITY_OR_OTHER||LS Mean Difference|-54.96|STANDARD_ERROR_OF_MEAN|5.701|<|0.0001|TWO_SIDED|95.0|-66.38|-43.54|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-43.54|-66.38|<0.0001
72558876|NCT01243151|144647847|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|24.972||||0.0472|TWO_SIDED|95.0|1.04|599.65|||Regression, Logistic|||Day 15: Logistic regression model with treatment and baseline LDL-C stratum as factors was used for the analysis.||599.65|1.04|0.0472
72558877|NCT01243151|144647847|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|11.815||||0.1368|TWO_SIDED|95.0|0.46|305.54|||Regression, Logistic|||Day 15: Logistic regression model with treatment and baseline LDL-C stratum as factors was used for the analysis.||305.54|0.46|0.1368
72558878|NCT01243151|144647847|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|47.527||||0.019|TWO_SIDED|95.0|1.89|1198.29|||Regression, Logistic|||Day 15: Logistic regression model with treatment and baseline LDL-C stratum as factors was used for the analysis.||1198.29|1.89|0.0190
72558879|NCT01243151|144647847|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|45.328||||0.0192|TWO_SIDED|95.0|1.86|1103.73|||Regression, Logistic|||Day 15: Logistic regression model with treatment and baseline LDL-C stratum as factors was used for the analysis.||1103.73|1.86|0.0192
72558880|NCT01243151|144647847|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|74.273||||0.0105|TWO_SIDED|95.0|2.74|2014.67|||Regression, Logistic|||Day 22: Logistic regression model with treatment and baseline LDL-C stratum as factors was used for the analysis.||2014.67|2.74|0.0105
72558881|NCT01243151|144647847|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|86.088||||0.0086|TWO_SIDED|95.0|3.1|2389.27|||Regression, Logistic|||Day 22: Logistic regression model with treatment and baseline LDL-C stratum as factors was used for the analysis.||2389.27|3.10|0.0086
72558882|NCT01243151|144647847|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|87.733||||0.0084|TWO_SIDED|95.0|3.14|2449.11|||Regression, Logistic|||Day 22: Logistic regression model with treatment and baseline LDL-C stratum as factors was used for the analysis.||2449.11|3.14|0.0084
72558883|NCT01243151|144647847|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|112.272||||0.0053|TWO_SIDED|95.0|4.07|3097.22|||Regression, Logistic|||Day 22: Logistic regression model with treatment and baseline LDL-C stratum as factors was used for the analysis.||3097.22|4.07|0.0053
72558884|NCT01243151|144647847|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|27.697||||0.0403|TWO_SIDED|95.0|1.16|662.2|||Regression, Logistic|||Day 29: Logistic regression model with treatment and baseline LDL-C stratum as factors was used for the analysis.||662.20|1.16|0.0403
72558885|NCT01243151|144647847|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|30.247||||0.0361|TWO_SIDED|95.0|1.25|733.32|||Regression, Logistic|||Day 29: Logistic regression model with treatment and baseline LDL-C stratum as factors was used for the analysis.||733.32|1.25|0.0361
72558886|NCT01243151|144647847|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|89.341||||0.0069|TWO_SIDED|95.0|3.43|2326.44|||Regression, Logistic|||Day 29: Logistic regression model with treatment and baseline LDL-C stratum as factors was used for the analysis.||2326.44|3.43|0.0069
72558887|NCT01243151|144647847|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|76.034||||0.0081|TWO_SIDED|95.0|3.08|1875.15|||Regression, Logistic|||Day 29: Logistic regression model with treatment and baseline LDL-C stratum as factors was used for the analysis.||1875.15|3.08|0.0081
72558888|NCT01243151|144647847|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.018||||0.9931|TWO_SIDED|95.0|0.02|64.41|||Regression, Logistic|||Day 36: Logistic regression model with treatment and baseline LDL-C stratum as factors was used for the analysis.||64.41|0.02|0.9931
72558889|NCT01243151|144647847|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|38.943||||0.0259|TWO_SIDED|95.0|1.55|975.84|||Regression, Logistic|||Day 36: Logistic regression model with treatment and baseline LDL-C stratum as factors was used for the analysis.||975.84|1.55|0.0259
72558890|NCT01243151|144647847|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|57.766||||0.0142|TWO_SIDED|95.0|2.26|1477.88|||Regression, Logistic|||Day 36: Logistic regression model with treatment and baseline LDL-C stratum as factors was used for the analysis.||1477.88|2.26|0.0142
72558891|NCT01243151|144647847|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|48.734||||0.0179|TWO_SIDED|95.0|1.95|1216.9|||Regression, Logistic|||Day 36: Logistic regression model with treatment and baseline LDL-C stratum as factors was used for the analysis.||1216.90|1.95|0.0179
72558892|NCT01243151|144647848|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|353.058||||0.0013|TWO_SIDED|95.0|9.95|12528.19|||Regression, Logistic|||Day 15: Logistic regression model with treatment and baseline LDL-C stratum as factors was used for the analysis.||12528.19|9.95|0.0013
72558893|NCT01243151|144647848|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|129.984||||0.0047|TWO_SIDED|95.0|4.44|3808.21|||Regression, Logistic|||Day 15: Logistic regression model with treatment and baseline LDL-C stratum as factors was used for the analysis.||3808.21|4.44|0.0047
72558894|NCT01243151|144647848|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|300.099||||0.0018|TWO_SIDED|95.0|8.35|10787.45|||Regression, Logistic|||Day 15: Logistic regression model with treatment and baseline LDL-C stratum as factors was used for the analysis.||10787.45|8.35|0.0018
72495618|NCT01808612|144520532|SUPERIORITY_OR_OTHER||LS Mean Difference|0.73||||0.264|TWO_SIDED|95.0|-0.55|2.0|||Mixed Models Analysis|||Approximately 522 participants were to be enrolled. Randomization was to be 2:1:3 (20 mg fluoxetine:40 mg fluoxetine:placebo). Assuming 5% of participants would have missing post-baseline data, the study had 85% power to detect an effect size of 0.33 (20 mg fluoxetine compared to placebo on HAMD21 total score) based on simulations with a 0.05 two-sided significance level.||2.00|-0.55|0.264
72495619|NCT04823949|144520539|OTHER||Risk Ratio (RR)|1.59|||<|0.001|TWO_SIDED|95.0|1.33|1.88|||Chi-squared|||||1.88|1.33|<0.001
72495620|NCT04823949|144520540|OTHER||Risk Ratio (RR)|1.35||||0.53|TWO_SIDED|95.0|0.52|3.49|||Fisher Exact|||||3.49|0.52|.530
72495621|NCT04823949|144520541|OTHER||Risk Ratio (RR)|2.53||||0.059|TWO_SIDED|95.0|0.92|6.9|||Fisher Exact|||||6.90|0.92|.059
72495622|NCT04823949|144520542|OTHER||Risk Ratio (RR)|0.84||||0.792|TWO_SIDED|95.0|0.23|3.04|||Fisher Exact|||||3.04|0.23|.792
72495623|NCT04823949|144520543|OTHER||Risk Ratio (RR)|1.11||||0.21|TWO_SIDED|95.0|0.94|1.31|||Chi-squared|||||1.31|0.94|.210
72558895|NCT01243151|144647848|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|190.835||||0.0025|TWO_SIDED|95.0|6.34|5743.12|||Regression, Logistic|||Day 15: Logistic regression model with treatment and baseline LDL-C stratum as factors was used for the analysis.||5743.12|6.34|0.0025
72558896|NCT01243151|144647848|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|255.421||||0.0018|TWO_SIDED|95.0|7.87|8290.22|||Regression, Logistic|||Day 22: Logistic regression model with treatment and baseline LDL-C stratum as factors was used for the analysis.||8290.22|7.87|0.0018
72558897|NCT01243151|144647848|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|150.547||||0.0034|TWO_SIDED|95.0|5.28|4291.89|||Regression, Logistic|||Day 22: Logistic regression model with treatment and baseline LDL-C stratum as factors was used for the analysis.||4291.89|5.28|0.0034
72558898|NCT01243151|144647848|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|745.542||||0.0018|TWO_SIDED|95.0|11.6|47929.45|||Regression, Logistic|||Day 22: Logistic regression model with treatment and baseline LDL-C stratum as factors was used for the analysis.||47929.45|11.60|0.0018
72558899|NCT01243151|144647848|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|146.296||||0.0031|TWO_SIDED|95.0|5.4|3963.01|||Regression, Logistic|||Day 22: Logistic regression model with treatment and baseline LDL-C stratum as factors was used for the analysis.||3963.01|5.40|0.0031
72558900|NCT01243151|144647848|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|213.512||||0.002|TWO_SIDED|95.0|7.13|6396.64|||Regression, Logistic|||Day 29: Logistic regression model with treatment and baseline LDL-C stratum as factors was used for the analysis.||6396.64|7.13|0.0020
72386872|NCT00579098|144281900|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||A p-value of \< 0.05 was considered statistically significant.|t-test, 2 sided|||The change in LDL cholesterol was compared between treatment groups.||||<0.001
72558901|NCT01243151|144647848|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|124.439||||0.0038|TWO_SIDED|95.0|4.73|3277.13|||Regression, Logistic|||Day 29: Logistic regression model with treatment and baseline LDL-C stratum as factors was used for the analysis.||3277.13|4.73|0.0038
72558902|NCT01243151|144647848|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|622.309||||0.002|TWO_SIDED|95.0|10.51|36846.03|||Regression, Logistic|||Day 29: Logistic regression model with treatment and baseline LDL-C stratum as factors was used for the analysis.||36846.03|10.51|0.0020
72558903|NCT01243151|144647848|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|224.427||||0.0017|TWO_SIDED|95.0|7.63|6598.0|||Regression, Logistic|||Day 29: Logistic regression model with treatment and baseline LDL-C stratum as factors was used for the analysis.||6598.00|7.63|0.0017
72558904|NCT01243151|144647848|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.158||||0.2751|TWO_SIDED|95.0|0.24|161.08|||Regression, Logistic|||Day 36: Logistic regression model with treatment and baseline LDL-C stratum as factors was used for the analysis.||161.08|0.24|0.2751
72558905|NCT01243151|144647848|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|152.977||||0.0038|TWO_SIDED|95.0|5.05|4633.92|||Regression, Logistic|||Day 36: Logistic regression model with treatment and baseline LDL-C stratum as factors was used for the analysis.||4633.92|5.05|0.0038
72495624|NCT01700192|144520547|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.8|||<|0.001|TWO_SIDED|95.0|-1.2|-0.4|||Wilcoxon (Mann-Whitney)|||||-0.40|-1.20|<0.001
72558906|NCT01243151|144647848|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|756.203||||0.002|TWO_SIDED|95.0|11.18|51133.53|||Regression, Logistic|||Day 36: Logistic regression model with treatment and baseline LDL-C stratum as factors was used for the analysis.||51133.53|11.18|0.0020
72495625|NCT01700192|144520547|SUPERIORITY_OR_OTHER||Treatment Difference Relative to Placebo|-17.2|||||TWO_SIDED|95.0|-25.0|-9.7||||||||-9.7|-25.0|
72495626|NCT01700192|144520550|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.6|||<|0.001|TWO_SIDED|95.0|-1.0|-0.3|||Wilcoxon (Mann-Whitney)|||||-0.30|-1.00|<0.001
72495627|NCT01700192|144520550|SUPERIORITY_OR_OTHER||Treatment Difference Relative to Placebo|-15.5|||||TWO_SIDED|95.0|-24.4|-7.3||||||||-7.3|-24.4|
72495628|NCT01700192|144520551|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.15||||0.154|TWO_SIDED|95.0|-0.35|0.05|||Zero-inflated Log-normal Model|||||0.05|-0.35|0.154
72495629|NCT01700192|144520551|SUPERIORITY_OR_OTHER||Treatment Difference Relative to Placebo|-18.4|||||TWO_SIDED|95.0|-41.0|4.3||||||||4.3|-41|
72495630|NCT01700192|144520552|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-1.1|||<|0.001|TWO_SIDED|95.0|-1.7|-0.6|||Wilcoxon (Mann-Whitney)|||||-0.60|-1.70|<0.001
72495631|NCT01700192|144520552|SUPERIORITY_OR_OTHER||Treatment Difference Relative to Placebo|-16.7|||||TWO_SIDED|95.0|-24.6|-4.0||||||||-4.0|-24.6|
72495632|NCT01700192|144520553|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-6.1|||<|0.001|TWO_SIDED|95.0|-9.1|-3.1|||Wilcoxon (Mann-Whitney)|||||-3.10|-9.10|<0.001
72495633|NCT01700192|144520553|SUPERIORITY_OR_OTHER||Treatment Difference Relative to Placebo|-16.0|||||TWO_SIDED|95.0|-22.7|-8.3||||||||-8.3|-22.7|
72495634|NCT02793232|144520609|SUPERIORITY||Percent change from baseline|-79.456|STANDARD_ERROR_OF_MEAN|0.0819|<|0.0001|TWO_SIDED|80.0|-81.56|-77.11|||Mixed Models Analysis|||ABeta 1-38: General linear model with treatment, as the fixed effect and loge(baseline) as covariate.||-77.11|-81.56|<0.0001
72495635|NCT02793232|144520609|SUPERIORITY||Percent change from baseline|-87.403|STANDARD_ERROR_OF_MEAN|0.0887|<|0.0001|TWO_SIDED|80.0|-88.8|-85.84|||Mixed Models Analysis|||ABeta 1-38: General linear model with treatment, as the fixed effect and loge(baseline) as covariate.||-85.84|-88.80|<0.0001
72495636|NCT02793232|144520609|SUPERIORITY||Percent change from baseline|-83.83|STANDARD_ERROR_OF_MEAN|0.0905|<|0.0001|TWO_SIDED|80.0|-85.65|-81.78|||Mixed Models Analysis|||ABeta 1-40: General linear model with treatment, as the fixed effect and loge(baseline) as covariate.||-81.78|-85.65|<0.0001
72618974|NCT00004228|144768331|SUPERIORITY_OR_OTHER|||||||0.63|TWO_SIDED||||||Regression, Cox|||"A Cox model was used to assess evidence of a difference in event-free survival comparing A1+B1 (1: no intensification) to A2 +B2 (2: intensification), while adjusting for the other intervention through stratification."||||.63
72386873|NCT00579098|144281900|SUPERIORITY_OR_OTHER|||||||0.92||95.0||||A p-value of \< 0.05 was considered statistically significant.|t-test, 2 sided|||The change in HDL cholesterol was compared between treatment groups.||||0.92
72386874|NCT00516074|144281913|NON_INFERIORITY_OR_EQUIVALENCE|Approximately 25 subjects were intended to be randomized to both the exenatide and placebo arms. Assuming an approximate 24% dropout rate, 19 patients per treatment arm would complete the study. A sample of 19 patients per treatment group would provide 90% power to detect a 10 bpm difference between treatment groups in change in daily mean heart rate from baseline.||||||0.1585||95.0|||||ANCOVA|||||||0.1585
72386875|NCT00516074|144281914|NON_INFERIORITY_OR_EQUIVALENCE|Power calculation for the primary endpoint is described as part of the primary endpoint information above.||||||0.1624||95.0|||||ANCOVA|||||||0.1624
72386876|NCT00516074|144281915|NON_INFERIORITY_OR_EQUIVALENCE|Power calculation for the primary endpoint is described as part of the primary endpoint information above.||||||0.5077||95.0|||||ANCOVA|||||||0.5077
72386877|NCT00516074|144281916|NON_INFERIORITY_OR_EQUIVALENCE|Power calculation for the primary endpoint is described as part of the primary endpoint information above.||||||0.9034||95.0|||||ANCOVA|||||||0.9034
72386878|NCT00516074|144281917|NON_INFERIORITY_OR_EQUIVALENCE|Power calculation for the primary endpoint is described as part of the primary endpoint information above.||||||0.427||95.0|||||ANCOVA|||||||0.4270
72386879|NCT00516074|144281918|NON_INFERIORITY_OR_EQUIVALENCE|Power calculation for the primary endpoint is described as part of the primary endpoint information above.||||||0.26||95.0|||||ANCOVA|||||||0.2600
72386880|NCT03329508|144281975|SUPERIORITY||Differences of Least Square Means|-2.66|STANDARD_ERROR_OF_MEAN|0.85||0.0018|TWO_SIDED|95.0|-4.33|-1.0|||MMRM|||||-1.0|-4.33|0.0018
72386881|NCT03329508|144281975|SUPERIORITY||Mean Difference (Net)|-3.3|STANDARD_ERROR_OF_MEAN|0.85||0.0001|TWO_SIDED|95.0|-4.96|-1.63|||MMRM|||||-1.63|-4.96|0.0001
72386882|NCT03329508|144281976|SUPERIORITY||Mean Difference (Net)|-2.66|STANDARD_ERROR_OF_MEAN|0.43|<|0.0001|TWO_SIDED|95.0|-3.5|-1.81|||MMRM|||||-1.81|-3.50|<0.0001
72386883|NCT03329508|144281976|SUPERIORITY||Mean Difference (Final Values)|-2.66|STANDARD_ERROR_OF_MEAN|0.43|<|0.05|TWO_SIDED|95.0|-3.5|-1.81|||MMRM|||||-1.81|-3.50|<0.05
72386884|NCT03329508|144281977|SUPERIORITY||Mean Difference (Net)|-1.52|STANDARD_ERROR_OF_MEAN|0.67||0.0231|TWO_SIDED|95.0|-2.84|-0.21|||MMRM|||||-0.21|-2.84|0.0231
72386885|NCT03329508|144281977|SUPERIORITY||Mean Difference (Net)|-1.75|STANDARD_ERROR_OF_MEAN|0.67||0.0092|TWO_SIDED|95.0|-3.06|-0.43|||MMRM|||||-0.43|-3.06|0.0092
72386886|NCT03329508|144281978|SUPERIORITY||Mean Difference (Net)|-1.17|STANDARD_ERROR_OF_MEAN|0.31||0.0001|TWO_SIDED|95.0|-1.77|-0.57|||MMRM|||||-0.57|-1.77|0.0001
72386887|NCT03329508|144281978|SUPERIORITY||Mean Difference (Net)|-1.52|STANDARD_ERROR_OF_MEAN|0.31|<|0.0001|TWO_SIDED|95.0|-2.13|-0.92|||MMRM|||||-0.92|-2.13|<0.0001
72386888|NCT03329508|144281979|SUPERIORITY||Mean Difference (Net)|-2.18|STANDARD_ERROR_OF_MEAN|1.54||0.1589|TWO_SIDED|95.0|-5.21|0.85|||MMRM|||||0.85|-5.21|0.1589
72386889|NCT00569270|144281983|SUPERIORITY_OR_OTHER|||||||0.027||95.0||||a priori threshold for statistical significance: p\<0.05|Mixed Models Analysis|||Mean difference of Peak FEV1 of tiotropium minus placebo. 29 patients needed to achieve a power of 80% at a significant alpha level of 5% using projected sample inspiratory capacity of 2.23+/- 0.5L post tiotropium compared to baseline inspiratory capacity 2.0+/-0.5L||||0.027
72386890|NCT00569270|144281984|SUPERIORITY_OR_OTHER||Spearman rho|0.19||||0.96||95.0||||A priori threshold for statistical significance: p=0.05|Spearman rho|||Correlation between improved lung function after tiotropium and extent of lung CT scored emphysema with respect to ratio functional residual capacity divided by total lung capacity. Specifically, correlation of tiotropium induced bronchodilation and extent of lung ct scored emphysema; measure includes change in FEV1 post tiotropium||||0.96
72386891|NCT00569270|144281985|SUPERIORITY_OR_OTHER|||||||0.318||95.0||||A priori threshold for statistical significance: p\<0.05|Mixed Models Analysis|||Mean difference of Peak FRC in tiotropium minus placebo. 29 patients needed to achieve a power of 80% at a significant alpha level of 5% using projected sample inspiratory capacity of 2.23+/- 0.5L post tiotropium compared to baseline inspiratory capacity 2.0+/-0.5L||||0.318
72386892|NCT00569270|144281986|SUPERIORITY_OR_OTHER|||||||0.078||95.0||||Statistical significance was p \< 0.05|Mixed Models Analysis|||Mean difference of Peak FVC of tiotropium minus placebo.29 patients needed to achieve a power of 80% at a significant alpha level of 5% using projected sample inspiratory capacity of 2.23+/- 0.5L post tiotropium compared to baseline inspiratory capacity 2.0+/-0.5L||||0.078
72386893|NCT00569270|144281987|SUPERIORITY_OR_OTHER||Spearman rho|-0.26||||0.4||95.0|||||Spearman rho|||Correlation between improved lung function after tiotropium and extent of lung CT scored emphysema with respect to ratio functional residual capacity divided by total lung capacity. Specifically, correlation of tiotropium induced bronchodilation and extent of lung ct scored emphysema (19 patients); measures include change in IC at trough tiotropium.||||0.4
72386894|NCT00569270|144281988|SUPERIORITY_OR_OTHER|||||||0.067||95.0||||A priori threshold for statistical significance: p\<0.05|Mixed Models Analysis|||Mean difference of Peak IC of tiotropium minus placebo.29 patients needed to achieve a power of 80% at a significant alpha level of 5% using projected sample inspiratory capacity of 2.23+/- 0.5L post tiotropium compared to baseline inspiratory capacity 2.0+/-0.5L||||0.067
72386895|NCT00569270|144281989|SUPERIORITY_OR_OTHER|||||||0.615||95.0||||A priori threshold for statistical significance: p\<0.05|Regression, Logistic|||Mean difference of Peak FRC/TLC of tiotropium minus placebo. 29 patients needed to achieve a power of 80% at a significant alpha level of 5% using projected sample inspiratory capacity of 2.23+/- 0.5L post tiotropium compared to baseline inspiratory capacity 2.0+/-0.5L||||0.615
72386896|NCT00569270|144281990|SUPERIORITY_OR_OTHER|||||||0.325||95.0||||Statistical significance was p\<0.05|Mixed Models Analysis|||29 patients needed to achieve a power of 80% at a significant alpha level of 5% using projected sample inspiratory capacity of 2.23+/- 0.5L post tiotropium compared to baseline inspiratory capacity 2.0+/-0.5L||||0.325
72618975|NCT02255279|144768350|NON_INFERIORITY_OR_EQUIVALENCE|"Hypothesis: Demonstrate non-inferiority (NI) of aTIV to TIV:~H0 : μAi - μBi ≤ -0.176 (Null) H1 : μAi - μBi \>-0.176 (alternative) (i= H1N1, H3N2, B) μA and μB are means of log10-transformed titers 21 days after last vaccination of the aTIV \& TIV vaccine groups respectively. NI is claimed if LL of 95% CI for GMT ratios is \>0.67.~Significance level is α = 2.5% (1-sided), which needs no further adjustment for multiplicity as to reach NI, above hypothesis needs to be rejected for all 3 strains."|Ratio of GMTs|4.06|||||TWO_SIDED|95.0|3.0|5.51|||ANCOVA|||Geometric mean titers (GMTs), in H1N1 strain of all the tree strains in Subjects 6 to \< 72 months of Age.||5.51|3.00|
72618976|NCT02255279|144768350|NON_INFERIORITY_OR_EQUIVALENCE|"Hypothesis: Demonstrate non-inferiority (NI) of aTIV to TIV:~H0 : μAi - μBi ≤ -0.176 (Null) H1 : μAi - μBi \>-0.176 (alternative) (i= H1N1, H3N2, B) μA and μB are means of log10-transformed titers 21 days after last vaccination of the aTIV \& TIV vaccine groups respectively. NI is claimed if LL of 95% CI for GMT ratios is \>0.67.~Significance level is α = 2.5% (1-sided), which needs no further adjustment for multiplicity as to reach NI, above hypothesis needs to be rejected for all 3 strains."|Ratio of GMTs|2.58|||||TWO_SIDED|95.0|2.05|3.25|||ANCOVA|||Geometric mean titers (GMTs), in H3N2 strain of all three homologous virus strains in Subjects 6 to \< 72 months of Age.||3.25|2.05|
72618977|NCT02255279|144768350|NON_INFERIORITY_OR_EQUIVALENCE|"Hypothesis: Demonstrate non-inferiority (NI) of aTIV to TIV:~H0 : μAi - μBi ≤ -0.176 (Null) H1 : μAi - μBi \>-0.176 (alternative) (i= H1N1, H3N2, B) μA and μB are means of log10-transformed titers 21 days after last vaccination of the aTIV \& TIV vaccine groups respectively. NI is claimed if LL of 95% CI for GMT ratios is \>0.67.~Significance level is α = 2.5% (1-sided), which needs no further adjustment for multiplicity as to reach NI, above hypothesis needs to be rejected for all 3 strains."|Ratio of GMTs|4.67|||||TWO_SIDED|95.0|3.52|6.2|||ANCOVA|||Geometric mean titers (GMTs), in B strain of all three homologous virus strains in Subjects 6 to \< 72 months of Age.||6.20|3.52|
72618978|NCT02255279|144768351|NON_INFERIORITY_OR_EQUIVALENCE|"The following hypotheses should be tested to demonstrate non-inferiority of aTIV to TIV:~H0i: πi1 \> πi2-0.1 vs. H1i: πi1 \> πi2- 0.1 where H0i and H1i represent the null and the alternative hypothesis (respectively) of the non- inferiority objective and πi1 and πi2 represent the seroresponse rates 21 days after last immunization of the aTIV and TIV vaccine groups respectively in the i-th strain (H1N1, H3N2, B). The non-inferiority criterion is -0.1 (i.e., -10%)."|Vaccine Group Differences|17.0|||||TWO_SIDED|95.0|8.1|26.3|||Loglinear model|Binary data were analyzed using loglinear models with a qualitative factor for vaccine group (αik, i = A, B) and center (δlk, k=1).||Percentage of subjects achieving seroconversion in H1N1 strain after last vaccination with aTIV or TIV in naïve and non-naive subjects.||26.3|8.1|
72618979|NCT02255279|144768351|NON_INFERIORITY_OR_EQUIVALENCE|"The following hypotheses should be tested to demonstrate non-inferiority of aTIV to TIV:~H0i: πi1 \> πi2-0.1 vs. H1i: πi1 \> πi2- 0.1 where H0i and H1i represent the null and the alternative hypothesis (respectively) of the non- inferiority objective and πi1 and πi2 represent the seroresponse rates 21 days after last immunization of the aTIV and TIV vaccine groups respectively in the i-th strain (H1N1, H3N2, B). The non-inferiority criterion is -0.1 (i.e., -10%)."|Vaccine Group Differences|10.0|||||TWO_SIDED|95.0|-1.8|21.0|||Loglinear model|Binary data were analyzed using loglinear models with a qualitative factor for vaccine group (αik, i = A, B) and center (δlk, k=1).||Percentage of subjects achieving seroconversion in H3N2 strain after last vaccination with aTIV or TIV in naive and non-naive subjects.||21|-1.8|
72618980|NCT02255279|144768351|NON_INFERIORITY_OR_EQUIVALENCE|"The following hypotheses should be tested to demonstrate non-inferiority of aTIV to TIV:~H0i: πi1 \> πi2-0.1 vs. H1i: πi1 \> πi2- 0.1 where H0i and H1i represent the null and the alternative hypothesis (respectively) of the non- inferiority objective and πi1 and πi2 represent the seroresponse rates 21 days after last immunization of the aTIV and TIV vaccine groups respectively in the i-th strain (H1N1, H3N2, B). The non-inferiority criterion is -0.1 (i.e., -10%)."|Vaccine Group Differences|58.0|||||TWO_SIDED|95.0|47.5|68.5|||Loglinear model|Binary data were analyzed using loglinear models with a qualitative factor for vaccine group (αik, i = A, B) and center (δlk, k=1).||Percentage of subjects achieving seroconversion in B strains after last vaccination with aTIV or TIV in naïve and non naive subjects.||68.5|47.5|
72618981|NCT02123511|144768393|SUPERIORITY|||||||0.1232|||||||t-test, 1 sided|||||||0.1232
72618982|NCT02123511|144768394|SUPERIORITY|||||||0.0422|||||||t-test, 1 sided|||||||0.0422
72618983|NCT02123511|144768395|SUPERIORITY|||||||0.5634|||||||t-test, 1 sided|||||||0.5634
72618984|NCT02123511|144768396|SUPERIORITY|||||||0.02|||||||t-test, 1 sided|||||||0.02
72439335|NCT02299375|144392641|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.21||||0.559|TWO_SIDED|95.0|-9.73|5.3||Analysis was performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment by visit and Baseline by visit interactions.|Mixed Models Analysis||SGRQ Impact, Week 39|||5.30|-9.73|0.559
72439336|NCT02299375|144392641|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.29||||0.809|TWO_SIDED|95.0|-12.19|9.6||Analysis was performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment by visit and Baseline by visit interactions.|Mixed Models Analysis||SGRQ Impact, Week 52|||9.60|-12.19|0.809
72439337|NCT00704184|144392653|SUPERIORITY_OR_OTHER||Adjusted difference in %|69.3|||<|0.001|TWO_SIDED|95.0|40.3|86.7|||Miettinen and Nurminen method||Adjusted difference subtracts the percentage of placebo responders (5.3%) and stratifies by HCV genotype (1a vs. non-1a).|||86.7|40.3|<0.001
72439338|NCT00704184|144392653|SUPERIORITY_OR_OTHER||Adjusted difference in %|73.6|||<|0.001|TWO_SIDED|95.0|46.0|88.6|||Miettinen and Nurminen method||Adjusted difference subtracts the percentage of placebo responders (5.3%) and stratifies by HCV genotype (1a vs. non-1a).|||88.6|46.0|<0.001
72439339|NCT00704184|144392653|SUPERIORITY_OR_OTHER||Adjusted difference in %|63.3|||<|0.001|TWO_SIDED|95.0|32.8|82.7|||Miettinen and Nurminen method||Adjusted difference subtracts the percentage of placebo responders (5.3%) and stratifies by HCV genotype (1a vs. non-1a).|||82.7|32.8|<0.001
72439340|NCT00704184|144392653|SUPERIORITY_OR_OTHER||Adjusted difference in %|77.8|||<|0.001|TWO_SIDED|95.0|49.2|91.3|||Miettinen and Nurminen method||Adjusted difference subtracts the percentage of placebo responders (5.3) and stratifies by HCV genotype (1a vs. non-1a).|||91.3|49.2|<0.001
72618985|NCT02123511|144768397|SUPERIORITY|||||||0.22|||||||t-test, 1 sided|||||||0.22
72618986|NCT02123511|144768398|SUPERIORITY|||||||0.02|||||||t-test, 1 sided|||||||0.02
72618987|NCT02123511|144768399|SUPERIORITY|||||||0.95|||||||t-test, 1 sided|||||||0.95
72558907|NCT01243151|144647848|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|258.938||||0.0021|TWO_SIDED|95.0|7.53|8902.61|||Regression, Logistic|||Day 36: Logistic regression model with treatment and baseline LDL-C stratum as factors was used for the analysis.||8902.61|7.53|0.0021
72558908|NCT01243151|144647849|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.896||||0.958|TWO_SIDED|95.0|0.02|52.79|||Regression, Logistic|||Logistic regression model with treatment and baseline LDL-C stratum as factors was used for the analysis.||52.79|0.02|0.9580
72558909|NCT01243151|144647849|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|17.375||||0.0732|TWO_SIDED|95.0|0.76|394.65|||Regression, Logistic|||Logistic regression model with treatment and baseline LDL-C stratum as factors was used for the analysis.||394.65|0.76|0.0732
72558910|NCT01243151|144647849|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|47.86||||0.0159|TWO_SIDED|95.0|2.07|1109.11|||Regression, Logistic|||Logistic regression model with treatment and baseline LDL-C stratum as factors was used for the analysis.||1109.11|2.07|0.0159
72558911|NCT01243151|144647849|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|33.246||||0.0264|TWO_SIDED|95.0|1.51|733.62|||Regression, Logistic|||Logistic regression model with treatment and baseline LDL-C stratum as factors was used for the analysis.||733.62|1.51|0.0264
72618988|NCT02123511|144768400|SUPERIORITY|||||||0.17|||||||t-test, 1 sided|||||||0.17
72439341|NCT00704184|144392656|SUPERIORITY_OR_OTHER||Adjusted difference|11.2|||||TWO_SIDED|95.0|-9.7|33.8|||||Adjusted difference subtracts the percentage of placebo responders (88.9%) and stratifies by HCV genotype (1a vs. non-1a).|||33.8|-9.7|
72439342|NCT00704184|144392656|SUPERIORITY_OR_OTHER||Adjusted difference|10.8|||||TWO_SIDED|95.0|-7.6|33.2|||||Adjusted difference subtracts the percentage of placebo responders (88.9%) and stratifies by HCV genotype (1a vs. non-1a).|||33.2|-7.6|
72618989|NCT02123511|144768401|SUPERIORITY|||||||0.48|||||||t-test, 1 sided|||||||0.48
72618990|NCT02123511|144768402|SUPERIORITY|||||||0.3824|||||||Wilcoxon (Mann-Whitney)|||||||0.3824
72618991|NCT03615534|144768403|SUPERIORITY|||||||0.0001||||||Results were evaluated in terms of adjusted end line TG levels, embracing the least significant difference (LSD) for pair-wise comparison. Probability of less than 0.05 was considered statistically significant.|MANCOVA|Covariates appearing in MANCOVA model are evaluated at the following baseline values: TG= 240.4 mg/dl, HDL-C = 31.8 mg/dl, ApoA1 = 144.6 mg/dl.||Multivariate Analysis of Covariance (MANCOVA), was applied to assess treatment effects among different arms, comprising the influence of the baseline TG level as a covariate, with further adjustments for baseline HDL-C, ApoA1levels.||||0.0001
72439343|NCT00704184|144392656|SUPERIORITY_OR_OTHER||Adjusted difference|11.2|||||TWO_SIDED|95.0|-9.7|33.8|||||Adjusted difference subtracts the percentage of placebo responders (88.9%) and stratifies by HCV genotype (1a vs. non-1a).|||33.8|-9.7|
72439344|NCT00704184|144392656|SUPERIORITY_OR_OTHER||Adjusted difference|5.4|||||TWO_SIDED|95.0|-16.5|28.4|||||Adjusted difference subtracts the percentage of placebo responders (88.9%) and stratifies by HCV genotype (1a vs. non-1a).|||28.4|-16.5|
72439345|NCT00704184|144392657|SUPERIORITY_OR_OTHER||Adjusted difference|16.9|||||TWO_SIDED|95.0|-4.0|40.2|||||Adjusted difference subtracts the percentage of placebo responders (83.3%) and stratifies by HCV genotype (1a vs. non-1a).|||40.2|-4.0|
72439346|NCT00704184|144392657|SUPERIORITY_OR_OTHER||Adjusted difference|16.2|||||TWO_SIDED|95.0|-2.2|39.5|||||Adjusted difference subtracts the percentage of placebo responders (83.3%) and stratifies by HCV genotype (1a vs. non-1a).|||39.5|-2.2|
72439347|NCT00704184|144392657|SUPERIORITY_OR_OTHER||Adjusted difference|16.9|||||TWO_SIDED|95.0|-4.0|40.2|||||Adjusted difference subtracts the percentage of placebo responders (83.3%) and stratifies by HCV genotype (1a vs. non-1a).|||40.2|-4.0|
72439348|NCT00704184|144392657|SUPERIORITY_OR_OTHER||Adjusted difference|10.7|||||TWO_SIDED|95.0|-11.4|34.6|||||Adjusted difference subtracts the percentage of placebo responders (83.3%) and stratifies by HCV genotype (1a vs. non-1a).|||34.6|-11.4|
72439349|NCT00704184|144392658|SUPERIORITY_OR_OTHER||Difference in Least Squares (LC) Means|-2.5|||||TWO_SIDED|95.0|-3.2|-1.8|||||The difference in LS Means reflects the mean decrease from baseline in HCV RNA between vaniprevir and placebo at Week 4.|||-1.8|-3.2|
72439350|NCT00704184|144392658|SUPERIORITY_OR_OTHER||Difference in LS Means|-2.7|||||TWO_SIDED|95.0|-3.4|-2.0|||||The difference in LS Means reflects the mean decrease from baseline in HCV RNA between vaniprevir and placebo at Week 4.|||-2.0|-3.4|
72439351|NCT00704184|144392658|SUPERIORITY_OR_OTHER||Difference in LS Means|-2.7|||||TWO_SIDED|95.0|-3.4|-2.0|||||The difference in LS Means reflects the mean decrease from baseline in HCV RNA between vaniprevir and placebo at Week 4.|||-2.0|-3.4|
72558912|NCT01243151|144647850|SUPERIORITY_OR_OTHER||LS Mean Difference|5.5|STANDARD_ERROR_OF_MEAN|5.131||0.2883|TWO_SIDED|95.0|-4.77|15.77|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||15.77|-4.77|0.2883
72618992|NCT03615534|144768404|SUPERIORITY|||||||0.06||||||Results were evaluated in terms of adjusted end line TC levels, embracing the least significant difference (LSD) for pair-wise comparison. Probability of less than 0.05 was considered statistically significant.|MANCOVA|Covariates appearing in MANCOVA model are evaluated at the following baseline values: TC=199.9 mg/dl, Non HDL-C= 168.0 mg/dl, d-LDL-C= 119.1 mg/dl.||Multivariate Analysis of Covariance (MANCOVA), was applied to assess treatment effects among different arms, comprising the influence of the baseline TC level as a covariate, with further adjustments for baseline Non HDL-C and d-LDL-C.||||0.060
72439352|NCT00704184|144392658|SUPERIORITY_OR_OTHER||Difference in LS Means|-2.7|||||TWO_SIDED|95.0|-3.3|-2.0|||||The difference in LS Means reflects the mean decrease from baseline in HCV RNA between vaniprevir and placebo at Week 4.|||-2.0|-3.3|
72439353|NCT03473340|144392703|SUPERIORITY|||||||0.17697507|||||||t-test, 2 sided|||P-Value provided is for net change only.||||0.17697507
72439354|NCT03473340|144392704|SUPERIORITY|||||||0.77367872|||||||Welch Two Sample t-test|||P-Value provided is for net change only.||||0.77367872
72439355|NCT03473340|144392705|SUPERIORITY|||||||0.68595748|||||||t-test, 2 sided|||P-Value provided is for net change only.||||0.68595748
72439356|NCT03473340|144392706|SUPERIORITY|||||||0.00127634|||||||Fisher Exact|||||||0.00127634
72439357|NCT03473340|144392707|SUPERIORITY|||||||0.80904544|||||||Fisher Exact|||||||0.80904544
72439358|NCT03394885|144392713|OTHER||Exact Binomial Confidence Interval|83.0|||||TWO_SIDED|95.0|66.0|100.0||||||||100|66|
72558913|NCT01243151|144647850|SUPERIORITY_OR_OTHER||LS Mean Difference|6.05|STANDARD_ERROR_OF_MEAN|5.277||0.2563|TWO_SIDED|95.0|-4.51|16.61|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||16.61|-4.51|0.2563
72558914|NCT01243151|144647850|SUPERIORITY_OR_OTHER||LS Mean Difference|1.92|STANDARD_ERROR_OF_MEAN|5.225||0.7149|TWO_SIDED|95.0|-8.54|12.37|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||12.37|-8.54|0.7149
72558915|NCT01243151|144647850|SUPERIORITY_OR_OTHER||LS Mean Difference|3.95|STANDARD_ERROR_OF_MEAN|5.174||0.448|TWO_SIDED|95.0|-6.4|14.3|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||14.30|-6.40|0.4480
72558916|NCT01243151|144647850|SUPERIORITY_OR_OTHER||LS Mean Difference|14.5|STANDARD_ERROR_OF_MEAN|6.214||0.0231|TWO_SIDED|95.0|2.06|26.94|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||26.94|2.06|0.0231
72439359|NCT02515305|144392726|EQUIVALENCE|provides 85% power of success|equivalence ratio|97.54|||||TWO_SIDED|90.0|94.6|104.7||No p-value calculated, just a T/R ratio and 90% confidence interval for the bioequivalence analysis|Fieller's method|||||104.7|94.6|
72439360|NCT02515305|144392727|EQUIVALENCE|provides 85% power of success|Equivalence ratio|100.1|||||TWO_SIDED|90.0|96.0|109.3|||Fieller's method|||||109.3|96|
72439361|NCT01351272|144392728|SUPERIORITY||||||=|0.09|||||||SPM two-sample t-test|||||||=0.09
72439362|NCT01351272|144392729|SUPERIORITY||||||=|0.16|||||||t-test, 1 sided|||||||= 0.16
72439363|NCT01351272|144392730|SUPERIORITY||||||=|0.09|||||||t-test, 1 sided|||||||= 0.09
72439364|NCT03949335|144392731|SUPERIORITY||||||<|0.0001|||||||t-test, 1 sided|||||||<0.0001
72439365|NCT03949335|144392732|SUPERIORITY||||||<|0.0001|||||||t-test, 1 sided|||||||<0.0001
72439366|NCT03949335|144392733|SUPERIORITY||||||<|0.0001|||||||t-test, 1 sided|||||||<0.0001
72439367|NCT03949335|144392734|NON_INFERIORITY|Noninferiority margin equals -0.1|Mean Difference (Final Values)|-0.031|||||TWO_SIDED|95.0|-0.053|-0.01||Success criteria was evaluated using lower confidence interval. No P-Value was calculated.||||||-0.010|-0.053|
72439368|NCT03949335|144392736|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||||||<0.0001
72439369|NCT01212991|144392737|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.706|||<|0.0001|TWO_SIDED|95.0|0.596|0.837||A 2-stage group sequential method (Lan DeMets OBF) assigned the level of significance for the pre-specified interim overall survival analysis (p\<0.015) based on overall 2-sided type I error rate of 0.049. Final results based upon interim analysis.|Log Rank||The hazard ratio is based on an unstratified Cox regression model (with treatment as the only covariate) and is relative to placebo with \<1 favoring enzalutamide.|||0.837|0.596|<0.0001
72439370|NCT01212991|144392738|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.186|||<|0.0001|TWO_SIDED|95.0|0.149|0.231||The assigned 2-sided type I error rate was 0.001 for the analysis of radiographic progression-free survival.|Log Rank||The hazard ratio is based on an unstratified Cox regression model (with treatment as the only covariate) and is relative to placebo with \< 1 favoring enzalutamide.|||0.231|0.149|<0.0001
72439371|NCT01212991|144392739|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.718|||<|0.0001||95.0|0.61|0.844||The Holm step down method of multiple comparisons was used to maintain a study wide type I error of 5% for prespecified secondary efficacy analyses. The 2-sided type I error rate was 0.01 for this analysis.|Log Rank||The hazard ratio is based on an unstratified Cox regression model (with treatment as the only covariate) and is relative to placebo with \< 1 favoring enzalutamide.|||0.844|0.610|<0.0001
72439372|NCT01212991|144392740|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.349|||<|0.0001||95.0|0.303|0.403||The Holm step down method of multiple comparisons was used to maintain a study wide type I error of 5% for prespecified secondary efficacy analyses. The 2-sided type I error rate was 0.0125 for this analysis.|Log Rank||The hazard ratio is based on an unstratified Cox regression model (with treatment as the only covariate) and is relative to placebo with \< 1 favoring enzalutamide.|||0.403|0.303|<0.0001
72439373|NCT01212991|144392741|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.169|||<|0.0001||95.0|0.147|0.195||The Holm step down method of multiple comparisons was used to maintain a study wide type I error of 5% for prespecified secondary efficacy analyses. The 2-sided type I error rate was 0.0167 for this analysis.|Log Rank||The hazard ratio is based on an unstratified Cox regression model (with treatment as the only covariate) and is relative to placebo with \< 1 favoring enzalutamide.|||0.195|0.147|<0.0001
72439374|NCT01212991|144392742|SUPERIORITY_OR_OTHER_LEGACY||Difference in response rates|74.51|||<|0.0001||95.0|71.45|77.57||The Holm step down method of multiple comparisons was used to maintain a study wide type I error of 5% for prespecified secondary efficacy analyses. The 2-sided type I error rate was 0.025 for this analysis.|Cochran-Mantel-Haenszel|||||77.57|71.45|<0.0001
72439375|NCT01212991|144392743|SUPERIORITY_OR_OTHER_LEGACY||Difference in objective response rate|53.85|||<|0.0001||95.0|48.53|59.17||The Holm step down method of multiple comparisons was used to maintain a study wide type I error of 5% for prespecified secondary efficacy analyses. The 2-sided type I error rate was 0.05 for this analysis.|Cochran-Mantel-Haenszel|||||59.17|48.53|<0.0001
72439376|NCT00801983|144392749|SUPERIORITY_OR_OTHER||||||>|0.05|||||||GEE|||Subjects were compared across keyboard types - The percentage of subjects with MSD when using the alternative keyboard were compared to the % of subjects with MSD when they were using the typical keyboard||||>.05
72439377|NCT05135000|144392764|OTHER||Cox Proportional Hazard|0.7||||0.6843|TWO_SIDED|80.0|0.2|2.8|||Log Rank|||||2.8|0.2|0.6843
72439378|NCT02763319|144392766|SUPERIORITY||Hazard Ratio (HR)|1.06||||0.468|TWO_SIDED|95.0|0.837|1.351|||Inverse normal test|The Inverse Normal method combines information (p-value) from the interim analysis and information from the final analysis.|The hazard ratio estimate for treatment was based on a stratified Cox model with stratification factors as per the Interactive Web Response System (IWRS). Rituximab + bendamustine was the reference treatment group.|||1.351|0.837|0.468
72558917|NCT01243151|144647850|SUPERIORITY_OR_OTHER||LS Mean Difference|11.13|STANDARD_ERROR_OF_MEAN|6.369||0.0858|TWO_SIDED|95.0|-1.62|23.87|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||23.87|-1.62|0.0858
72439379|NCT02763319|144392767|SUPERIORITY||Hazard Ratio (HR)|0.88||||0.568|TWO_SIDED|95.0|0.586|1.33|||Inverse normal test|The Inverse Normal method combines information (p-value) from the interim analysis and information from the final analysis.|The hazard ratio estimate for treatment was based on a stratified Cox model with stratification factors as per the Interactive Web Response System. Rituximab + bendamustine is the reference treatment group.|||1.330|0.586|0.568
72439380|NCT02763319|144392768|SUPERIORITY||Odds Ratio (OR)|1.2|||||TWO_SIDED|95.0|0.812|1.779|||||||A Cochran-Mantel-Haenszel (CMH) test stratified by Baseline stratification factors was performed for response variable coded as follows: 1 for response (CR or PR) and 0 for nonresponse (stable disease \[SD\] or progressive disease \[PD\] or unknown).|1.779|0.812|
72439381|NCT02763319|144392769|SUPERIORITY||Odds Ratio (OR)|1.54|||||TWO_SIDED|95.0|0.778|3.041|||||||A Cochran-Mantel-Haenszel (CMH) test stratified by Baseline stratification factors was performed for response variable coded as follows: 1 for response (CR or PR) and 0 for nonresponse (stable disease \[SD\] or progressive disease \[PD\] or unknown).|3.041|0.778|
72439382|NCT02763319|144392770|SUPERIORITY||Hazard Ratio (HR)|1.28|||||TWO_SIDED|95.0|0.938|1.745|||||||The hazard ratio estimate for treatment was based on a stratified Cox model with stratification factors as per IWRS. Rituximab + bendamustine was the reference treatment group.|1.745|0.938|
72439383|NCT02763319|144392771|SUPERIORITY||Hazard Ratio (HR)|1.16|||||TWO_SIDED|95.0|0.673|2.035|||||||The hazard ratio estimate for treatment was based on a stratified Cox model with stratification factors as per IWRS. Rituximab + bendamustine was the reference treatment group.|2.035|0.673|
72558918|NCT01243151|144647850|SUPERIORITY_OR_OTHER||LS Mean Difference|7.57|STANDARD_ERROR_OF_MEAN|6.431||0.244|TWO_SIDED|95.0|-5.3|20.44|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||20.44|-5.30|0.2440
72558919|NCT01243151|144647850|SUPERIORITY_OR_OTHER||LS Mean Difference|11.52|STANDARD_ERROR_OF_MEAN|6.249||0.0702|TWO_SIDED|95.0|-0.98|24.03|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||24.03|-0.98|0.0702
72618993|NCT03615534|144768404|SUPERIORITY|||||||0.0001||||||Results were evaluated in terms of adjusted end line HDL-C levels, embracing the least significant difference (LSD) for pair-wise comparison. Probability of less than 0.05 was considered statistically significant.|MANCOVA|Covariates appearing in MANCOVA model are evaluated at the following baseline values: HDL-C = 31.8 mg/dL,TG= 240.4 mg/dL, ApoA1 = 144.6 mg/dL.||Multivariate Analysis of Covariance (MANCOVA), was applied to assess treatment effects among different arms, comprising the influence of the baseline HDL-C level as a covariate, with further adjustments for baselineTG, ApoA1levels.||||0.0001
72558920|NCT01243151|144647850|SUPERIORITY_OR_OTHER||LS Mean Difference|9.64|STANDARD_ERROR_OF_MEAN|4.878||0.0531|TWO_SIDED|95.0|-0.13|19.41|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||19.41|-0.13|0.0531
72439384|NCT02763319|144392772|SUPERIORITY||Hazard Ratio (HR)|1.13|||||TWO_SIDED|95.0|0.875|1.452|||||||The hazard ratio estimate for treatment was based on a stratified Cox model with stratification factors as per IWRS. Rituximab + bendamustine was the reference treatment group.|1.452|0.875|
72439385|NCT02763319|144392773|SUPERIORITY||Hazard Ratio (HR)|1.05|||||TWO_SIDED|95.0|0.682|1.626|||||||The hazard ratio estimate for treatment was based on a stratified Cox model with stratification factors as per IWRS. Rituximab + bendamustine was the reference treatment group.|1.626|0.682|
72439386|NCT02763319|144392774|SUPERIORITY||Odds Ratio (OR)|1.28|||||TWO_SIDED|95.0|0.829|1.985|||||||A CMH test stratified by Baseline stratification factors was performed for response variable coded as follows: 1 for response (CR or PR) and 0 for nonresponse (stable disease \[SD\] or progressive disease \[PD\] or unknown).|1.985|0.829|
72439387|NCT02763319|144392775|SUPERIORITY||Odds Ratio (OR)|1.62|||||TWO_SIDED|95.0|0.755|3.457|||||||A CMH test stratified by Baseline stratification factors was performed for response variable coded as follows: 1 for response (CR or PR) and 0 for nonresponse (stable disease \[SD\] or progressive disease \[PD\] or unknown).|3.457|0.755|
72439388|NCT02763319|144392776|SUPERIORITY||Hazard Ratio (HR)|1.08|||||TWO_SIDED|95.0|0.831|1.416|||||||The hazard ratio estimate for treatment was based on a stratified Cox model with stratification factors as per IWRS. Rituximab + bendamustine was the reference treatment group.|1.416|0.831|
72439389|NCT02763319|144392777|SUPERIORITY||Hazard Ratio (HR)|1.0|||||TWO_SIDED|95.0|0.633|1.595|||||||The hazard ratio estimate for treatment was based on a stratified Cox model with stratification factors as per IWRS. Rituximab + bendamustine was the reference treatment group.|1.595|0.633|
72495637|NCT02793232|144520609|SUPERIORITY||Percent change from baseline|-92.138|STANDARD_ERROR_OF_MEAN|0.1041|<|0.0001|TWO_SIDED|80.0|-93.15|-90.98|||Mixed Models Analysis|||ABeta 1-40: General linear model with treatment, as the fixed effect and loge(baseline) as covariate.||-90.98|-93.15|<0.0001
72439390|NCT02763319|144392778|SUPERIORITY||Hazard Ratio (HR)|0.99|||||TWO_SIDED|95.0|0.794|1.244|||||||The hazard ratio estimate for treatment was based on a stratified Cox model with stratification factors as per IWRS. Rituximab + bendamustine was the reference treatment group.|1.244|0.794|
72439391|NCT02763319|144392779|SUPERIORITY||Hazard Ratio (HR)|0.83|||||TWO_SIDED|95.0|0.57|1.22|||||||The hazard ratio estimate for treatment was based on a stratified Cox model with stratification factors as per IWRS. Rituximab + bendamustine was the reference treatment group.|1.220|0.570|
72495638|NCT02793232|144520609|SUPERIORITY||Percent change from baseline|-84.814|STANDARD_ERROR_OF_MEAN|0.0971|<|0.0001|TWO_SIDED|80.0|-86.64|-82.74|||Mixed Models Analysis|||ABeta 1-42: General linear model with treatment, as the fixed effect and loge(baseline) as covariate.||-82.74|-86.64|<0.0001
72495639|NCT02793232|144520609|SUPERIORITY||Percent change from baseline|-92.87|STANDARD_ERROR_OF_MEAN|0.1114|<|0.0001|TWO_SIDED|80.0|-93.85|-91.74|||Mixed Models Analysis|||ABeta 1-42: General linear model with treatment, as the fixed effect and loge(baseline) as covariate.||-91.74|-93.85|<0.0001
72439392|NCT03538717|144392804|SUPERIORITY|||||||0.113|||||||Chi-squared|||Statistics analysis (P value) was performed compositely for all the categories reported.||||0.113
72439393|NCT03538717|144392805|SUPERIORITY|||||||0.228|||||||Fisher Exact|||Statistics analysis (P value) was performed compositely for all the categories reported.||||0.228
72439394|NCT03538717|144392806|SUPERIORITY|||||||0.02|||||||Chi-squared|||Statistics analysis (P value) was performed compositely for all the categories reported.||||0.020
72439395|NCT03538717|144392807|SUPERIORITY|||||||0.138|||||||Chi-squared|||Statistics analysis (P value) was performed compositely for all the categories reported.||||0.138
72439396|NCT03538717|144392808|SUPERIORITY|||||||0.524|||||||Chi-squared|||Statistics analysis (P value) was performed compositely for all the categories reported.||||0.524
72439397|NCT03538717|144392809|SUPERIORITY|||||||0.265|||||||Chi-squared|||Statistics analysis (P value) was performed compositely for all the categories reported.||||0.265
72439398|NCT03538717|144392810|SUPERIORITY|||||||0.035|||||||Chi-squared|||Statistics analysis (P value) was performed compositely for all the categories reported.||||0.035
72439399|NCT03538717|144392811|SUPERIORITY|||||||0.123|||||||Chi-squared|||Statistics analysis (P value) was performed compositely for all the categories reported.||||0.123
72439400|NCT03538717|144392812|SUPERIORITY|||||||0.327|||||||Chi-squared|||Statistics analysis (P value) was performed compositely for all the categories reported.||||0.327
72439401|NCT03538717|144392813|SUPERIORITY|||||||0.419|||||||Chi-squared|||Statistics analysis (P value) was performed compositely for all the categories reported.||||0.419
72439402|NCT03538717|144392814|SUPERIORITY|||||||0.01|||||||Fisher Exact|||Statistics analysis (P value) was performed compositely for all the categories reported.||||0.010
72439403|NCT03538717|144392815|SUPERIORITY|||||||0.446|||||||Chi-squared|||100% clear cells||||0.446
72439404|NCT03538717|144392815|SUPERIORITY|||||||0.596|||||||Chi-squared|||100% non-clear cells||||0.596
72439405|NCT03538717|144392815|SUPERIORITY|||||||0.578|||||||Chi-squared|||Majority component of clear cells||||0.578
72558921|NCT01243151|144647850|SUPERIORITY_OR_OTHER||LS Mean Difference|8.93|STANDARD_ERROR_OF_MEAN|4.94||0.0758|TWO_SIDED|95.0|-0.96|18.83|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||18.83|-0.96|0.0758
72439406|NCT03538717|144392815|SUPERIORITY|||||||0.706|||||||Fisher Exact|||Majority component of non-clear cells||||0.706
72439407|NCT03538717|144392816|SUPERIORITY|||||||0.074|||||||Chi-squared|||Statistics analysis (P value) was performed compositely for all the categories reported.||||0.074
72439408|NCT03538717|144392817|SUPERIORITY|||||||0.07|||||||Chi-squared|||Statistics analysis (P value) was performed compositely for all the categories reported.||||0.070
72439409|NCT03538717|144392818|SUPERIORITY|||||||0.091|||||||Chi-squared|||Statistics analysis (P value) was performed compositely for all the categories reported.||||0.091
72439410|NCT03538717|144392819|SUPERIORITY|||||||0.046|||||||Chi-squared|||Lymph nodes||||0.046
72439411|NCT03538717|144392819|SUPERIORITY||||||>|0.999|||||||Fisher Exact|||CNS||||>0.999
72439412|NCT03538717|144392819|SUPERIORITY|||||||0.026|||||||Chi-squared|||Hepatic||||0.026
72439413|NCT03538717|144392819|SUPERIORITY|||||||0.327|||||||Chi-squared|||Pulmonary||||0.327
72558922|NCT01243151|144647850|SUPERIORITY_OR_OTHER||LS Mean Difference|1.95|STANDARD_ERROR_OF_MEAN|4.975||0.6965|TWO_SIDED|95.0|-8.01|11.92|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||11.92|-8.01|0.6965
72558923|NCT01243151|144647850|SUPERIORITY_OR_OTHER||LS Mean Difference|13.52|STANDARD_ERROR_OF_MEAN|4.842||0.0071|TWO_SIDED|95.0|3.83|23.22|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||23.22|3.83|0.0071
72439414|NCT03538717|144392819|SUPERIORITY|||||||0.024|||||||Chi-squared|||Bone||||0.024
72439415|NCT03538717|144392819|SUPERIORITY|||||||0.045|||||||Chi-squared|||Another site of metastasis||||0.045
72439416|NCT03538717|144392820|SUPERIORITY|||||||0.555|||||||Chi-squared|||LDH level \>1.5\*ULN||||0.555
72439417|NCT03538717|144392820|SUPERIORITY||||||<|0.001|||||||Chi-squared|||Hgb levels \<=LLN||||<0.001
72439418|NCT03538717|144392820|SUPERIORITY|||||||0.344|||||||Chi-squared|||Corrected Ca levels \>10 mg/dL||||0.344
72439419|NCT03538717|144392820|SUPERIORITY||||||>|0.999|||||||Chi-squared|||Neutrophil levels \>ULN||||>0.999
72439420|NCT03538717|144392820|SUPERIORITY|||||||0.795|||||||Chi-squared|||Platelet levels \>ULN||||0.795
72439421|NCT03538717|144392820|SUPERIORITY|||||||0.184|||||||Chi-squared|||Neutrophil-to-lymphocyte ratio \<=3||||0.184
72439422|NCT03538717|144392821|SUPERIORITY|||||||0.235|||||||Chi-squared|||Statistics analysis (P value) was performed compositely for all the categories reported.||||0.235
72439423|NCT01951170|144392849|SUPERIORITY_OR_OTHER|||||||0.83||||||Change in mTSS scores from baseline to Week 24.|Wilcoxon signed rank test|||||||0.83
72439424|NCT01305252|144392869|SUPERIORITY_OR_OTHER|||||||0.03|||||||t-test, 2 sided|||||||0.03
72439425|NCT01305252|144392869|SUPERIORITY_OR_OTHER|||||||0.17|||||||t-test, 2 sided|||||||0.17
72439426|NCT01305252|144392872|SUPERIORITY_OR_OTHER|||||||0.03|||||||t-test, 2 sided|||||||0.03
72439427|NCT01305252|144392872|SUPERIORITY_OR_OTHER|||||||0.33|||||||t-test, 2 sided|||||||0.33
72439428|NCT04512482|144392875|SUPERIORITY|||||||0.044|||||||ANOVA|||A power analysis determined that a sample size of forty-five (45) subjects would possess 90% power to detect an effect size of 0.5 between the intervention and control legs of the crossover design. With 43 total subjects the study had between 85 and 90% power.||||.044
72495640|NCT02793232|144520609|SUPERIORITY||Percent change from baseline|-79.465|STANDARD_ERROR_OF_MEAN|0.087|<|0.0001|TWO_SIDED|80.0|-81.69|-76.96|||Mixed Models Analysis|||ABeta x-38: General linear model with treatment, as the fixed effect and loge(baseline) as covariate.||-76.96|-81.69|<0.0001
72439429|NCT02918279|144392959|SUPERIORITY||Treatment difference|-0.22||||0.0022|TWO_SIDED|95.0|-0.37|-0.08|||ANCOVA||Liraglutide 3.0 mg - Placebo|Analysis of in-trial data with missing observations was imputed from the placebo arm based on a jump to reference multiple (x100) imputation approach. Responses at week 56 were analysed using an analysis of covariance model with treatment, sex, region, baseline glycaemic category, stratification factor for Tanner stage and interaction between baseline glycaemic category and stratification factor for Tanner stage as fixed effects, baseline BMI SDS, age as covariates.||-0.08|-0.37|0.0022
72439430|NCT01641198|144393029|SUPERIORITY||Mean Difference (Final Values)|-0.29|STANDARD_ERROR_OF_MEAN|0.115|<|0.05|TWO_SIDED|95.0|-0.59|0.01||Statistical analysis was based on the mixed linear model with the level of significance set at p\<0.05 and Bonferroni correction for pairwise comparisons|Mixed Models Analysis|Mixed linear model with effects of time, implant position, implant configuration, implant type (and implant length as a covariate effect)||Mean bone change between B and SW estimated with the mixed linear model (mean±SE, 95% CI)||0.01|-0.59|<0.05
72439431|NCT01641198|144393029|SUPERIORITY||Mean Difference (Final Values)|0.39|STANDARD_ERROR_OF_MEAN|0.12|<|0.05|TWO_SIDED|95.0|0.09|0.69||Statistical analysis was based on the mixed linear model with the level of significance set at p\<0.05 and Bonferroni correction for pairwise comparisons|Mixed Models Analysis|Mixed linear model with effects of time, implant position, implant configuration, implant type (and implant length as a covariate effect)||Mean bone change between B and SC estimated with the mixed linear model (mean±SE, 95% CI)||0.69|0.09|<0.05
72439432|NCT01641198|144393029|SUPERIORITY||Mean Difference (Final Values)|-0.685|STANDARD_ERROR_OF_MEAN|0.115|<|0.05|TWO_SIDED|95.0|-0.98|-0.39||Statistical analysis was based on the mixed linear model with the level of significance set at p\<0.05 and Bonferroni correction for pairwise comparisons|Mixed Models Analysis|Mixed linear model with effects of time, implant position, implant configuration, implant type (and implant length as a covariate effect)||Mean bone change between SW and SC estimated with the mixed linear model (mean±SE, 95% CI)||-0.39|-0.98|<0.05
72439433|NCT01641198|144393030|SUPERIORITY||Mean Difference (Final Values)|-0.17|STANDARD_ERROR_OF_MEAN|0.135|<|0.05|TWO_SIDED|95.0|-0.47|0.13||Statistical analysis was based on the mixed linear model with the level of significance set at p\<0.05 and Bonferroni correction for pairwise comparisons|Mixed Models Analysis|Mixed linear model with effects of time, implant position, implant configuration, implant type (and implant length as a covariate effect)||Mean bone change between B and SW estimated with the mixed linear model (mean±SE, 95% CI)||0.13|-0.47|<0.05
72439434|NCT01641198|144393030|SUPERIORITY||Mean Difference (Final Values)|0.56|STANDARD_ERROR_OF_MEAN|0.13|<|0.05|TWO_SIDED|95.0|0.26|0.85||Statistical analysis was based on the mixed linear model with the level of significance set at p\<0.05 and Bonferroni correction for pairwise comparisons|Mixed Models Analysis|Mixed linear model with effects of time, implant position, implant configuration, implant type (and implant length as a covariate effect)||Mean bone change between B and SC estimated with the mixed linear model (mean±SE, 95% CI)||0.85|0.26|<0.05
72439435|NCT01641198|144393030|SUPERIORITY||Mean Difference (Final Values)|-0.725|STANDARD_ERROR_OF_MEAN|0.135|<|0.05|TWO_SIDED|95.0|-1.02|-0.43||Statistical analysis was based on the mixed linear model with the level of significance set at p\<0.05 and Bonferroni correction for pairwise comparisons|Mixed Models Analysis|Mixed linear model with effects of time, implant position, implant configuration, implant type (and implant length as a covariate effect)||Mean bone change between SW and SC estimated with the mixed linear model (mean±SE, 95% CI)||-0.43|-1.02|<0.05
72439436|NCT01641198|144393031|SUPERIORITY||Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|0.2|<|0.05|TWO_SIDED|95.0|-0.19|0.59||Statistical analysis was based on the mixed linear model with the level of significance set at p\<0.05 and Bonferroni correction for pairwise comparisons|Mixed Models Analysis|Mixed linear model with effects of time, implant position, implant configuration, implant type (and implant length as a covariate effect)||Mean bone change between B and SW estimated with the mixed linear model (mean±SE, 95% CI)||0.59|-0.19|<0.05
72495641|NCT02793232|144520609|SUPERIORITY||Percent change from baseline|-88.711|STANDARD_ERROR_OF_MEAN|0.0963|<|0.0001|TWO_SIDED|80.0|-90.06|-87.18|||Mixed Models Analysis|||ABeta x-38: General linear model with treatment, as the fixed effect and loge(baseline) as covariate.||-87.18|-90.06|<0.0001
72439437|NCT01641198|144393031|SUPERIORITY||Mean Difference (Final Values)|0.83|STANDARD_ERROR_OF_MEAN|0.2|<|0.05|TWO_SIDED|95.0|0.45|1.22||Statistical analysis was based on the mixed linear model with the level of significance set at p\<0.05 and Bonferroni correction for pairwise comparisons|Mixed Models Analysis|Mixed linear model with effects of time, implant position, implant configuration, implant type (and implant length as a covariate effect)||Mean bone change between B and SC estimated with the mixed linear model (mean±SE, 95% CI)||1.22|0.45|<0.05
72495642|NCT02793232|144520609|SUPERIORITY||Percent change from baseline|-78.936|STANDARD_ERROR_OF_MEAN|0.0824|<|0.0001|TWO_SIDED|80.0|-81.11|-76.52|||Mixed Models Analysis|||ABeta x-40: General linear model with treatment, as the fixed effect and loge(baseline) as covariate.||-76.52|-81.11|<0.0001
72558924|NCT01243151|144647850|SUPERIORITY_OR_OTHER||LS Mean Difference|11.2|STANDARD_ERROR_OF_MEAN|5.155||0.0339|TWO_SIDED|95.0|0.88|21.52|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||21.52|0.88|0.0339
72439438|NCT01641198|144393031|SUPERIORITY||Mean Difference (Final Values)|-0.635|STANDARD_ERROR_OF_MEAN|0.2|<|0.05|TWO_SIDED|95.0|-1.01|-0.26||Statistical analysis was based on the mixed linear model with the level of significance set at p\<0.05 and Bonferroni correction for pairwise comparisons|Mixed Models Analysis|Mixed linear model with effects of time, implant position, implant configuration, implant type (and implant length as a covariate effect)||Mean bone change between SW and SC estimated with the mixed linear model (mean±SE, 95% CI).||-0.26|-1.01|<0.05
72495643|NCT02793232|144520609|SUPERIORITY||Percent change from baseline|-86.28|STANDARD_ERROR_OF_MEAN|0.0899|<|0.0001|TWO_SIDED|80.0|-87.82|-84.55|||Mixed Models Analysis|||ABeta x-40: General linear model with treatment, as the fixed effect and loge(baseline) as covariate.||-84.55|-87.82|<0.0001
72495644|NCT02793232|144520609|SUPERIORITY||Percent change from baseline|-79.648|STANDARD_ERROR_OF_MEAN|0.0664|<|0.0001|TWO_SIDED|80.0|-81.36|-77.78|||Mixed Models Analysis|||ABeta x-42: General linear model with treatment, as the fixed effect and loge(baseline) as covariate.||-77.78|-81.36|<0.0001
72558925|NCT01243151|144647850|SUPERIORITY_OR_OTHER||LS Mean Difference|8.56|STANDARD_ERROR_OF_MEAN|5.235||0.1075|TWO_SIDED|95.0|-1.92|19.03|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||19.03|-1.92|0.1075
72439439|NCT01068743|144393036|NON_INFERIORITY_OR_EQUIVALENCE|BE was concluded if the 90% confidence intervals (CIs) for the test-to-reference ratios (B/A) of geometric means were entirely contained within 80% to 125% for both Cmax and AUC0-inf of saxagliptin.|Ratio (%) of Geometric LS Means|101.45|||||TWO_SIDED|90.0|98.17|104.84|||||Ratio=Treatment B/Treatment A. Geometric least squares means values are presented in other statistical analysis entries. LS=Least Squares.|If there was no difference between the bioavailabilities of saxagliptin from the FDC tablet versus saxagliptin from coadministration of saxagliptin and metformin tablets under both fasted and fed conditions, then 20 participants would have provided 98% and 99% power to conclude bioequivalence (BE) with respect to Cmax and AUC0-inf, respectively. If there was a 5% difference, then 20 participants would have provided 93% and 99% power to conclude BE with respect to Cmax and AUC0-inf, respectively.||104.84|98.17|
72439440|NCT01068743|144393036|NON_INFERIORITY_OR_EQUIVALENCE|BE was concluded if the 90% CIs for the test-to-reference ratios (D/C) of geometric means were entirely contained within 80% to 125% for both Cmax and AUC0-inf of saxagliptin.|Ratio (%) of Geometric LS Means|102.43|||||TWO_SIDED|90.0|99.53|105.42|||||Ratio=Treatment D/Treatment C. Geometric least squares means values are presented in other statistical analysis entries.|If there was no difference between the bioavailabilities of saxagliptin from the FDC tablet versus saxagliptin from coadministration of saxagliptin and metformin tablets under both fasted and fed conditions, then 20 participants would have provided 98% and 99% power to conclude BE with respect to Cmax and AUC0-inf, respectively. If there was a 5% difference, then 20 participants would have provided 93% and 99% power to conclude BE with respect to Cmax and AUC0-inf,respectively.||105.42|99.53|
72439441|NCT01068743|144393036|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean (ng*hr/mL)|49.23||||||||||||||Geometric least squares means for Treatment A.||||
72439442|NCT01068743|144393036|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean (ng*hr/mL)|49.94||||||||||||||Geometric least squares means for Treatment B.||||
72439443|NCT01068743|144393036|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean (ng*hr/mL)|52.71||||||||||||||Geometric least squares means for Treatment C.||||
72439444|NCT01068743|144393036|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean (ng*hr/mL)|53.99||||||||||||||Geometric least squares means for Treatment D.||||
72439445|NCT01068743|144393039|NON_INFERIORITY_OR_EQUIVALENCE|BE was concluded if the 90% CIs for the test-to-reference ratios (B/A) of geometric means were entirely contained within 80% to 125% for both Cmax and AUC0-inf of saxagliptin.|Ratio (%) of Geometric LS Means|102.46|||||TWO_SIDED|90.0|94.68|110.88|||||Ratio=Treatment B/Treatment A. Geometric least squares means values are presented in other statistical analysis entries.|If there was no difference between the bioavailabilities of saxagliptin from the FDC tablet versus saxagliptin from coadministration of saxagliptin and metformin tablets under both fasted and fed conditions, then 20 participants would have provided 98% and 99% power to conclude BE with respect to Cmax and AUC0-inf, respectively. If there was a 5% difference, then 20 participants would have provided 93% and 99% power to conclude BE with respect to Cmax and AUC0-inf, respectively.||110.88|94.68|
72439446|NCT01068743|144393039|NON_INFERIORITY_OR_EQUIVALENCE|BE was concluded if the 90% CIs for the test-to-reference ratios (D/C) of geometric means were entirely contained within 80% to 125% for both Cmax and AUC0-inf of saxagliptin.|Ratio (%) of Geometric LS Means|106.24|||||TWO_SIDED|90.0|98.43|114.66|||||Ratio=Treatment D/Treatment C. Geometric least squares means values presented in other statistical analysis entries.|If there was no difference between the bioavailabilities of saxagliptin from the FDC tablet versus saxagliptin from coadministration of saxagliptin and metformin tablets under both fasted and fed conditions, then 20 participants would have provided 98% and 99% power to conclude BE with respect to Cmax and AUC0-inf, respectively. If there was a 5% difference, then 20 participants would have provided 93% and 99% power to conclude BE with respect to Cmax and AUC0-inf, respectively.||114.66|98.43|
72495645|NCT02793232|144520609|SUPERIORITY||Percent change from baseline|-84.985|STANDARD_ERROR_OF_MEAN|0.0715|<|0.0001|TWO_SIDED|80.0|-86.34|-83.5|||Mixed Models Analysis|||ABeta x-42: General linear model with treatment, as the fixed effect and loge(baseline) as covariate.||-83.50|-86.34|<0.0001
72439447|NCT01068743|144393039|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean (ng/mL)|9.73||||||||||||||Geometric least squares means for Treatment A.||||
72439448|NCT01068743|144393039|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean (ng/mL)|9.97||||||||||||||Geometric least squares means for Treatment B.||||
72439449|NCT01068743|144393039|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean (ng/mL)|10.33||||||||||||||Geometric least squares means for Treatment C.||||
72439450|NCT01068743|144393039|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean (ng/mL)|10.97||||||||||||||Geometric least squares means for Treatment D.||||
72439451|NCT01068743|144393040|NON_INFERIORITY_OR_EQUIVALENCE|BE was concluded if the 90% CIs for the test-to-reference ratios (B/A) of geometric means were entirely contained within 80% to 125% for both Cmax and AUC0-inf of metformin.|Ratio (%) of Geometric LS Means|102.1|||||TWO_SIDED|90.0|97.26|107.18|||||Ratio = Treatment B/Treatment A. Geometric least squares means values are presented in other statistical analysis entries.|If there was no difference between the bioavailabilities of metformin from the FDC tablet versus metformin from coadministration of saxagliptin and metformin tablets under both fasted and fed conditions, then 20 participants would have provided 99% power to conclude BE with respect to each of Cmax and AUC0-inf. If there was a 5% difference, then 20 subjects would provide 97% and 99% power to conclude BE with respect to Cmax and AUC0-inf, respectively.||107.18|97.26|
72495646|NCT02793232|144520609|SUPERIORITY||Percent change from baseline|72.893|STANDARD_ERROR_OF_MEAN|0.0809|<|0.0001|TWO_SIDED|80.0|55.37|92.4|||Mixed Models Analysis|||sAPP-alpha: General linear model with treatment, as the fixed effect and loge(baseline) as covariate.||92.40|55.37|<0.0001
72495647|NCT02793232|144520609|SUPERIORITY||Percent change from baseline|98.049|STANDARD_ERROR_OF_MEAN|0.0897|<|0.0001|TWO_SIDED|80.0|75.92|122.96|||Mixed Models Analysis|||sAPP-alpha: General linear model with treatment, as the fixed effect and loge(baseline) as covariate.||122.96|75.92|<0.0001
72495648|NCT02793232|144520609|SUPERIORITY||Percent change from baseline|-80.164|STANDARD_ERROR_OF_MEAN|0.0668|<|0.0001|TWO_SIDED|80.0|-81.84|-78.33|||Mixed Models Analysis|||sAPP-beta: General linear model with treatment, as the fixed effect and loge(baseline) as covariate.||-78.33|-81.84|<0.0001
72495649|NCT02793232|144520609|SUPERIORITY||Percent change from baseline|-83.381|STANDARD_ERROR_OF_MEAN|0.0733|<|0.0001|TWO_SIDED|80.0|-84.92|-81.69|||Mixed Models Analysis|||sAPP-beta: General linear model with treatment, as the fixed effect and loge(baseline) as covariate.||-81.69|-84.92|<0.0001
72495650|NCT02793232|144520609|SUPERIORITY||Percent change from baseline|-78.408|STANDARD_ERROR_OF_MEAN|0.0602|<|0.0001|TWO_SIDED|80.0|-80.06|-76.62|||Mixed Models Analysis|||Abeta total: General linear model with treatment, as the fixed effect and loge(baseline) as covariate||-76.62|-80.06|<0.0001
72495651|NCT02793232|144520609|SUPERIORITY||Percent change from baseline|-85.365|STANDARD_ERROR_OF_MEAN|0.0653|<|0.0001|TWO_SIDED|80.0|-86.57|-84.05|||Mixed Models Analysis|||Abeta total: General linear model with treatment, as the fixed effect and loge(baseline) as covariate.||-84.05|-86.57|<0.0001
72495652|NCT01405053|144520620|SUPERIORITY||LS Mean difference|2.601|STANDARD_ERROR_OF_MEAN|6.558||0.6928|TWO_SIDED|95.0|-10.5|15.7|||ANCOVA|||The primary statistical model for comparing the 2 treatment groups was an analysis of covariance (ANCOVA) mixed model for repeated measures with baseline score, age, and sex as covariates, and treatment, week, and treatment by week interaction as factors.||15.7|-10.5|0.6928
72495653|NCT02642094|144520630|SUPERIORITY|||||||0.002|||||||t-test, 2 sided|||||||0.0020
72495654|NCT02642094|144520631|SUPERIORITY|||||||0.0137|||||||t-test, 2 sided|||||||0.0137
72495655|NCT02642094|144520632|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
72495656|NCT02642094|144520633|SUPERIORITY|||||||0.0072|||||||t-test, 2 sided|||||||0.0072
72495657|NCT02642094|144520634|SUPERIORITY|||||||0.3093|||||||t-test, 2 sided|||||||0.3093
72495658|NCT00993928|144520641|SUPERIORITY_OR_OTHER_LEGACY|||||||0.85|||||||Wilcoxon (Mann-Whitney)|||Comparison of Q3: Percent change in sleep latency from baseline to week 7.||||0.85
72495659|NCT00993928|144520641|SUPERIORITY_OR_OTHER_LEGACY|||||||0.86|||||||Wilcoxon (Mann-Whitney)|||Comparison of Q6A: Percent change in time to fall back asleep from baseline to week 7.||||0.86
72495660|NCT00993928|144520643|SUPERIORITY_OR_OTHER_LEGACY|||||||0.42|||||||Chi-squared|||||||0.42
72495661|NCT00993928|144520645|SUPERIORITY_OR_OTHER_LEGACY|||||||0.64|||||||t-test, 2 sided|||Compare percent change from baseline to week 7 Distress Thermometer score.||||0.64
72386897|NCT00569270|144281991|SUPERIORITY_OR_OTHER|||||||0.345||95.0|||||Mixed Models Analysis|||29 patients needed to achieve a power of 80% at a significant alpha level of 5% using projected sample inspiratory capacity of 2.23+/- 0.5L post tiotropium compared to baseline inspiratory capacity 2.0+/-0.5L||||0.345
72386898|NCT00569270|144281992|SUPERIORITY_OR_OTHER|||||||0.068||95.0||||A priori threshold for statistical significance: p\<0.05|Mixed Models Analysis|||Mean difference of Trough FRC(L) in tiotropium minus placebo. 29 patients needed to achieve a power of 80% at a significant alpha level of 5% using projected sample inspiratory capacity of 2.23+/- 0.5L post tiotropium compared to baseline inspiratory capacity 2.0+/-0.5L||||0.068
72386899|NCT00569270|144281993|SUPERIORITY_OR_OTHER|||||||0.589||95.0||||A priori threshold for statistical significance: p\<0.05|Mixed Models Analysis|||Mean difference of trough FVC in tiotropium minus placebo. 29 patients needed to achieve a power of 80% at a significant alpha level of 5% using projected sample inspiratory capacity of 2.23+/- 0.5L post tiotropium compared to baseline inspiratory capacity 2.0+/-0.5L||||0.589
72386900|NCT00569270|144281994|SUPERIORITY_OR_OTHER|||||||0.922||95.0||||A priori threshold for statistical significance: p\<0.05|Mixed Models Analysis|||Mean difference of Trough IC of tiotropium minus placebo. 29 patients needed to achieve a power of 80% at a significant alpha level of 5% using projected sample inspiratory capacity of 2.23+/- 0.5L post tiotropium compared to baseline inspiratory capacity 2.0+/-0.5L||||0.922
72386901|NCT00569270|144281995|SUPERIORITY_OR_OTHER|||||||-0.02||95.0||||A priori threshold for statistical significance: p\<0.05|Mixed Models Analysis|||Mean difference of Trough FRC/TLC of tiotropium minus placebo. 29 patients needed to achieve a power of 80% at a significant alpha level of 5% using projected sample inspiratory capacity of 2.23+/- 0.5L post tiotropium compared to baseline inspiratory capacity 2.0+/-0.5L||||-0.02
72386902|NCT00569270|144281996|SUPERIORITY_OR_OTHER|||||||-0.13||95.0||||A priori threshold for statistical significance: p\<0.05|Mixed Models Analysis|||Mean difference of Trough TLC (L) of tiotropium minus placebo. 29 patients needed to achieve a power of 80% at a significant alpha level of 5% using projected sample inspiratory capacity of 2.23+/- 0.5L post tiotropium compared to baseline inspiratory capacity 2.0+/-0.5L||||-0.13
72386903|NCT00569270|144281997|SUPERIORITY_OR_OTHER|||||||0.0001||95.0||||A priori threshold for statistical significance: p\<0.05|Mixed Models Analysis|||Change in IC before and after dynamic hyperinflation. 29 patients needed to achieve a power of 80% at a significant alpha level of 5% using projected sample inspiratory capacity of 2.23+/- 0.5L post tiotropium compared to baseline inspiratory capacity 2.0+/-0.5L||||0.0001
72386904|NCT00569270|144281998|SUPERIORITY_OR_OTHER||||||>|0.05||95.0||||Total lung capacity was similar in all groups and was not significant|Mixed Models Analysis|||29 patients needed to achieve a power of 80% at a significant alpha level of 5% using projected sample inspiratory capacity of 2.23+/- 0.5L post tiotropium compared to baseline inspiratory capacity 2.0+/-0.5L||||>0.05
72386905|NCT00569270|144281999|SUPERIORITY_OR_OTHER|||||||0.36||95.0||||A priori threshold for statistical significance: p= 0.05|Spearman rho|Spearman rho = -0.26||Correlation between improved lung function after tiotropium and extent of lung CT scored emphysema with respect to ratio functional residual capacity divided by total lung capacity. Specifically, correlation of tiotropium induced bronchodilation and extent of lung ct scored emphysema||||0.36
72386906|NCT03855228|144282014|SUPERIORITY|||||||0.36|||||||ANOVA|||This analysis compares Change From Baseline values.||||0.36
72386907|NCT03855228|144282014|SUPERIORITY||||||<|0.01|||||||ANOVA|||This analysis compares Change From Baseline values.||||<0.01
72386908|NCT03855228|144282014|SUPERIORITY||||||<|0.01|||||||ANOVA|||This analysis compares Change From Baseline values.||||<0.01
72386909|NCT03855228|144282014|SUPERIORITY||||||<|0.01|||||||ANOVA|||This analysis compares Change From Baseline values.||||<0.01
72439452|NCT01068743|144393040|NON_INFERIORITY_OR_EQUIVALENCE|BE was concluded if the 90% CIs for the test-to-reference ratios (B/A) of geometric means were entirely contained within 80% to 125% for both Cmax and AUC0-inf of metformin.|Ratio (%) of Geometric LS Means|99.17|||||TWO_SIDED|90.0|96.23|102.21|||||Ratio=Treatment D/Treatment C. Geometric least squares means values are presented in other statistical analysis entries.|If there was no difference between the bioavailabilities of metformin from the FDC tablet versus metformin from coadministration of saxagliptin and metformin tablets under both fasted and fed conditions, then 20 participants would have provided 99% power to conclude BE with respect to each of Cmax and AUC0-inf. If there was a 5% difference, then 20 subjects would provide 97% and 99% power to conclude BE with respect to Cmax and AUC0-inf, respectively.||102.21|96.23|
72439453|NCT01068743|144393040|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean (ng*hr/mL)|11998.0||||||||||||||Geometric least squares mean for Treatment A.||||
72439454|NCT01068743|144393040|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean (ng*hr/mL)|12250.0||||||||||||||Geometric least squares means for Treatment B.||||
72439455|NCT01068743|144393040|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean (ng*hr/mL)|12036.0||||||||||||||Geometric least squares means for Treatment C.||||
72439456|NCT01068743|144393040|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean (ng*hr/mL)|11937.0||||||||||||||Geometric least squares means for Treatment D.||||
72439457|NCT01068743|144393041|NON_INFERIORITY_OR_EQUIVALENCE|BE was concluded if the 90% CIs for the test-to-reference ratios (B/A) of geometric means were entirely contained within 80% to 125% for both Cmax and AUC0-inf of metformin.|Ratio (%) of Geometric LS Means|99.5|||||TWO_SIDED|90.0|90.41|109.5|||||Ratio=Treatment B/Treatment A. Geometric least squares means values presented in other statistical analysis entries.|If there was no difference between the bioavailabilities of metformin from the FDC tablet versus metformin from coadministration of saxagliptin and metformin tablets under both fasted and fed conditions, then 20 participants would have provided 99% power to conclude BE with respect to each of Cmax and AUC0-inf. If there was a 5% difference, then 20 subjects would provide 97% and 99% power to conclude BE with respect to Cmax and AUC0-inf, respectively.||109.5|90.41|
72439458|NCT01068743|144393041|NON_INFERIORITY_OR_EQUIVALENCE|BE was concluded if the 90% CIs for the test-to-reference ratios (D/C) of geometric means were entirely contained within 80% to 125% for both Cmax and AUC0-inf of metformin.|Ratio (%) of Geometric LS Means|98.22|||||TWO_SIDED|90.0|94.28|102.32|||||Ratio=Treatment D/Treatment C. Geometric least squares means values presented in other statistical analysis entries.|If there was no difference between the bioavailabilities of metformin from the FDC tablet versus metformin from coadministration of saxagliptin and metformin tablets under both fasted and fed conditions, then 20 participants would have provided 99% power to conclude BE with respect to each of Cmax and AUC0-inf. If there was a 5% difference, then 20 subjects would provide 97% and 99% power to conclude BE with respect to Cmax and AUC0-inf, respectively.||102.32|94.28|
72439459|NCT01068743|144393041|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean (ng/mL|1724.4||||||||||||||Geometric least squares means for Treatment A.||||
72439460|NCT01068743|144393041|SUPERIORITY_OR_OTHER||Geometric Least Square Means (ng/mL)|1715.8||||||||||||||Geometric least squares means for Treatment B.||||
72439461|NCT01068743|144393041|SUPERIORITY_OR_OTHER||Geometric Least Square Mean (ng/mL)|1581.4||||||||||||||Geometric least squares means for Treatment C.||||
72439462|NCT01068743|144393041|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean (ng/mL)|1553.2||||||||||||||Geometric least squares means for Treatment D.||||
72439463|NCT01068743|144393046|SUPERIORITY_OR_OTHER||Ratio (%) of Geometric LS Means|101.43|||||TWO_SIDED|90.0|98.07|104.9|||||Ratio=Treatment B/Treatment A. Geometric least squares means values presented in other statistical analysis entries.|||104.90|98.07|
72439464|NCT01068743|144393046|SUPERIORITY_OR_OTHER||Ratio (%) of Geometric LS Means|102.52|||||TWO_SIDED|90.0|99.56|105.57|||||Ratio=Treatment D/Treatment C. Geometric least squares means values presented in other statistical analysis entries.|||105.57|99.56|
72439465|NCT01068743|144393046|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean (ng*h/mL)|47.15|||||||||||||Geometric least squares means for Treatment A.|||||
72439466|NCT01068743|144393046|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean (ng*h/mL)|47.83|||||||||||||Geometric least squares means for Treatment B.|||||
72439467|NCT01068743|144393046|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean (ng*h/mL)|50.89|||||||||||||Geometric least squares means for Treatment C.|||||
72439468|NCT01068743|144393046|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean (ng*h/mL)|52.17|||||||||||||Geometric least squares means for Treatment D.|||||
72439469|NCT01068743|144393049|SUPERIORITY_OR_OTHER||Ratio (%) of Geometric LS Means|100.41|||||TWO_SIDED|90.0|95.4|105.68|||||Ratio=Treatment B/Treatment A. Geometric least squares means values presented in other statistical analysis entries.|||105.68|95.40|
72439470|NCT01068743|144393049|SUPERIORITY_OR_OTHER||Ratio (%) of Geometric LS Means|99.06|||||TWO_SIDED|90.0|96.19|102.02|||||Ratio=Treatment D/Treatment C. Geometric least squares means values presented in other statistical analysis entries.|||102.02|96.19|
72439471|NCT01068743|144393049|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean (ng*h/mL)|11827.0|||||||||||||Geometric least squares means for Treatment A.|||||
72439472|NCT01068743|144393049|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean (ng*h/mL)|11875.0|||||||||||||Geometric least squares means for Treatment B.|||||
72439473|NCT01068743|144393049|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean (ng*h/mL)|11845.0|||||||||||||Geometric least squares means for Treatment C.|||||
72439474|NCT01068743|144393049|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean (ng*h/mL)|11734.0|||||||||||||Geometric least squares means for Treatment D.|||||
72439475|NCT02507752|144393054|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANOVA|||Physical component score at Week 24: The statistical hypothesis (H0) that the change is equal to 0 is evaluated using the Repeated Measures Analysis of Variance (ANOVA).||||< 0.001
72439476|NCT02507752|144393054|SUPERIORITY_OR_OTHER||||||=|0.014|TWO_SIDED||||||ANOVA|||Mental component score at Week 24: The statistical hypothesis (H0) that the change is equal to 0 is evaluated using the Repeated Measures Analysis of Variance (ANOVA).||||= 0.014
72439477|NCT02507752|144393056|SUPERIORITY_OR_OTHER||||||=|0.021|TWO_SIDED||||||ANOVA|||Mean change from Baseline in ESR at Week 12: The statistical hypothesis (H0) that the change is equal to 0 is evaluated using the Repeated Measures Analysis of Variance (ANOVA)||||= 0.021
72439478|NCT02507752|144393056|SUPERIORITY_OR_OTHER||||||=|0.003|TWO_SIDED||||||ANOVA|||Mean change from Baseline in ESR at Week 24: The statistical hypothesis (H0) that the change is equal to 0 is evaluated using the Repeated Measures Analysis of Variance (ANOVA)||||= 0.003
72439479|NCT02507752|144393057|SUPERIORITY_OR_OTHER||||||=|0.744|TWO_SIDED||||||ANOVA|||Mean change from Baseline in CRP at Week 12: The statistical hypothesis (H0) that the change is equal to 0 is evaluated using the Repeated Measures Analysis of Variance (ANOVA)||||= 0.744
72439480|NCT02507752|144393057|SUPERIORITY_OR_OTHER||||||=|0.646|TWO_SIDED||||||ANOVA|||Mean change from Baseline in CRP at Week 24: The statistical hypothesis (H0) that the change is equal to 0 is evaluated using the Repeated Measures Analysis of Variance (ANOVA)||||= 0.646
72439481|NCT02507752|144393058|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANOVA|||Mean change from Baseline in SJC at Week 12: The statistical hypothesis (H0) that the change is equal to 0 is evaluated using the Repeated Measures Analysis of Variance (ANOVA)||||< 0.001
72439482|NCT02507752|144393058|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANOVA|||Mean change from Baseline in SJC at Week 24: The statistical hypothesis (H0) that the change is equal to 0 is evaluated using the Repeated Measures Analysis of Variance (ANOVA)||||< 0.001
72439483|NCT02507752|144393059|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANOVA|||Mean change from Baseline in TJC at Week 12: The statistical hypothesis (H0) that the change is equal to 0 is evaluated using the Repeated Measures Analysis of Variance (ANOVA)||||< 0.001
72439484|NCT02507752|144393059|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANOVA|||Mean change from Baseline in TJC at Week 24: The statistical hypothesis (H0) that the change is equal to 0 is evaluated using the Repeated Measures Analysis of Variance (ANOVA)||||< 0.001
72439485|NCT02507752|144393060|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANOVA|||Mean change from Baseline in DAS28 at Week 12: The statistical hypothesis (H0) that the change is equal to 0 is evaluated using the Repeated Measures Analysis of Variance (ANOVA)||||< 0.001
72439486|NCT02507752|144393060|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANOVA|||Mean change from Baseline in DAS28 at Week 24: The statistical hypothesis (H0) that the change is equal to 0 is evaluated using the Repeated Measures Analysis of Variance (ANOVA)||||< 0.001
72439487|NCT02507752|144393061|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANOVA|||Mean change from Baseline in patient global assessment at Week 12: The statistical hypothesis (H0) that the change is equal to 0 is evaluated using the Repeated Measures Analysis of Variance (ANOVA)||||< 0.001
72439488|NCT02507752|144393061|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANOVA|||Mean change from Baseline in patient global assessment at Week 24: The statistical hypothesis (H0) that the change is equal to 0 is evaluated using the Repeated Measures Analysis of Variance (ANOVA)||||< 0.001
72439489|NCT02507752|144393062|SUPERIORITY_OR_OTHER||||||=|0.011|TWO_SIDED||||||ANOVA|||Change in HAQ score from screening to Week 12: The statistical hypothesis (H0) that the change is equal to 0 is evaluated using the Repeated Measures Analysis of Variance (ANOVA)||||= 0.011
72439490|NCT02507752|144393062|SUPERIORITY_OR_OTHER||||||=|0.001|TWO_SIDED||||||ANOVA|||Change in HAQ score from screening to Week 24: The statistical hypothesis (H0) that the change is equal to 0 is evaluated using the Repeated Measures Analysis of Variance (ANOVA)||||= 0.001
72439491|NCT02507752|144393063|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANOVA|||Change in pain scale from screening to Week 12: The statistical hypothesis (H0) that the change is equal to 0 is evaluated using the Repeated Measures Analysis of Variance (ANOVA)||||< 0.001
72439492|NCT02507752|144393063|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANOVA|||Change in pain scale from screening to Week 24: The statistical hypothesis (H0) that the change is equal to 0 is evaluated using the Repeated Measures Analysis of Variance (ANOVA)||||< 0.001
72439493|NCT02507752|144393064|SUPERIORITY_OR_OTHER||||||=|0.001|TWO_SIDED||||||ANOVA|||Physical component score at Week 12: The statistical hypothesis (H0) that the change is equal to 0 is evaluated using the Repeated Measures Analysis of Variance (ANOVA)||||= 0.001
72495662|NCT04871711|144520646|SUPERIORITY||Risk Difference (RD)|9.8||||0.006|TWO_SIDED|95.0|3.6|16.1||5% significance level (two-sided).|Cochran-Mantel-Haenszel|Stratified by region and baseline IGA-CHE score.|Mantel-Haenszel risk difference, stratified by region and baseline IGA-CHE score.|Based on the primary analysis of the primary estimand 'composite'. Subjects with missing data, subjects who received rescue treatment, or subjects who permanently discontinued IMP were considered non-responders.||16.1|3.6|0.006
72495663|NCT04871711|144520647|SUPERIORITY||Risk Difference (RD)|24.1|||<|0.001|TWO_SIDED|95.0|15.5|32.6||Evaluated at 5% significance level (two-sided) using hierarchical tests, alpha splitting and alpha recycling controlling overall type 1 error at 5% (two-sided).|Cochran-Mantel-Haenszel|Stratified by region and baseline IGA-CHE score.|Mantel-Haenszel risk difference, stratified by region and baseline IGA-CHE score.|Based on the primary analysis of the primary estimand 'composite'. Subjects with missing data, subjects who received rescue treatment, or subjects who permanently discontinued IMP were considered non-responders.||32.6|15.5|<0.001
72439494|NCT02507752|144393064|SUPERIORITY_OR_OTHER||||||=|0.001|TWO_SIDED||||||ANOVA|||Mental component score at Week 12: The statistical hypothesis (H0) that the change is equal to 0 is evaluated using the Repeated Measures Analysis of Variance (ANOVA)||||= 0.001
72439495|NCT02507752|144393065|SUPERIORITY_OR_OTHER||||||=|0.102|TWO_SIDED||||||ANOVA|||Physical functioning domain at Week 12: The statistical hypothesis (H0) that the change is equal to 0 is evaluated using the Repeated Measures Analysis of Variance (ANOVA)||||= 0.102
72439496|NCT02507752|144393065|SUPERIORITY_OR_OTHER||||||=|0.008|TWO_SIDED||||||ANOVA|||Physical functioning domain at Week 24: The statistical hypothesis (H0) that the change is equal to 0 is evaluated using the Repeated Measures Analysis of Variance (ANOVA)||||= 0.008
72439497|NCT02507752|144393065|SUPERIORITY_OR_OTHER||||||=|0.008|TWO_SIDED||||||ANOVA|||Role physical domain at Week 12: The statistical hypothesis (H0) that the change is equal to 0 is evaluated using the Repeated Measures Analysis of Variance (ANOVA)||||= 0.008
72439498|NCT02507752|144393065|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANOVA|||Role physical domain at Week 24: The statistical hypothesis (H0) that the change is equal to 0 is evaluated using the Repeated Measures Analysis of Variance (ANOVA)||||< 0.001
72439499|NCT02507752|144393065|SUPERIORITY_OR_OTHER||||||=|0.002|TWO_SIDED||||||ANOVA|||Bodily pain domain at Week 12: The statistical hypothesis (H0) that the change is equal to 0 is evaluated using the Repeated Measures Analysis of Variance (ANOVA)||||= 0.002
72439500|NCT02507752|144393065|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANOVA|||Bodily pain domain at Week 24: The statistical hypothesis (H0) that the change is equal to 0 is evaluated using the Repeated Measures Analysis of Variance (ANOVA)||||< 0.001
72495664|NCT04871711|144520648|SUPERIORITY||Risk Difference (RD)|22.8|||<|0.001|TWO_SIDED|95.0|14.0|31.7||Evaluated at 5% significance level (two-sided) using hierarchical tests, alpha splitting and alpha recycling controlling overall type 1 error at 5% (two-sided).|Cochran-Mantel-Haenszel|Stratified by region and baseline IGA-CHE score.|Mantel-Haenszel risk difference, stratified by region and baseline IGA-CHE score.|Based on the primary analysis of the primary estimand 'composite'. Subjects with missing data, subjects who received rescue treatment, or subjects who permanently discontinued IMP were considered non-responders.||31.7|14.0|<0.001
72439501|NCT02507752|144393065|SUPERIORITY_OR_OTHER||||||=|0.077|TWO_SIDED||||||ANOVA|||General health domain at Week 12: The statistical hypothesis (H0) that the change is equal to 0 is evaluated using the Repeated Measures Analysis of Variance (ANOVA)||||= 0.077
72439502|NCT02507752|144393065|SUPERIORITY_OR_OTHER||||||=|0.068|TWO_SIDED||||||ANOVA|||General health domain at Week 24: The statistical hypothesis (H0) that the change is equal to 0 is evaluated using the Repeated Measures Analysis of Variance (ANOVA)||||= 0.068
72439503|NCT02507752|144393065|SUPERIORITY_OR_OTHER||||||=|0.018|TWO_SIDED||||||ANOVA|||Vitality domain at Week 12: The statistical hypothesis (H0) that the change is equal to 0 is evaluated using the Repeated Measures Analysis of Variance (ANOVA)||||= 0.018
72439504|NCT02507752|144393065|SUPERIORITY_OR_OTHER||||||=|0.053|TWO_SIDED||||||ANOVA|||Vitality domain at Week 24: The statistical hypothesis (H0) that the change is equal to 0 is evaluated using the Repeated Measures Analysis of Variance (ANOVA)||||= 0.053
72439505|NCT02507752|144393065|SUPERIORITY_OR_OTHER||||||=|0.002|TWO_SIDED||||||ANOVA|||Social functioning domain at Week 12: The statistical hypothesis (H0) that the change is equal to 0 is evaluated using the Repeated Measures Analysis of Variance (ANOVA)||||= 0.002
72439506|NCT02507752|144393065|SUPERIORITY_OR_OTHER||||||=|0.003|TWO_SIDED||||||ANOVA|||Social functioning domain at Week 24: The statistical hypothesis (H0) that the change is equal to 0 is evaluated using the Repeated Measures Analysis of Variance (ANOVA)||||= 0.003
72439507|NCT02507752|144393065|SUPERIORITY_OR_OTHER||||||=|0.015|TWO_SIDED||||||ANOVA|||Role emotional domain at Week 12: The statistical hypothesis (H0) that the change is equal to 0 is evaluated using the Repeated Measures Analysis of Variance (ANOVA)||||= 0.015
72495665|NCT04871711|144520649|SUPERIORITY||Risk Difference (RD)|12.3||||0.001|TWO_SIDED|95.0|5.7|18.9||Evaluated at 4% significance level (two-sided) using hierarchical tests, alpha splitting and alpha recycling controlling overall type 1 error at 5% (two-sided).|Cochran-Mantel-Haenszel|Stratified by region and baseline IGA-CHE score.|Mantel-Haenszel risk difference, stratified by region and baseline IGA-CHE score.|Based on the primary analysis of the primary estimand 'composite'. Subjects with missing data, subjects who received rescue treatment, or subjects who permanently discontinued IMP were considered non-responders.||18.9|5.7|0.001
72439508|NCT02507752|144393065|SUPERIORITY_OR_OTHER||||||=|0.154|TWO_SIDED||||||ANOVA|||Role emotional domain at Week 24: The statistical hypothesis (H0) that the change is equal to 0 is evaluated using the Repeated Measures Analysis of Variance (ANOVA)||||= 0.154
72439509|NCT02507752|144393065|SUPERIORITY_OR_OTHER||||||=|0.024|TWO_SIDED||||||ANOVA|||Mental health domain at Week 12: The statistical hypothesis (H0) that the change is equal to 0 is evaluated using the Repeated Measures Analysis of Variance (ANOVA)||||= 0.024
72439510|NCT02507752|144393065|SUPERIORITY_OR_OTHER||||||=|0.029|TWO_SIDED||||||ANOVA|||Mental health domain at Week 24: The statistical hypothesis (H0) that the change is equal to 0 is evaluated using the Repeated Measures Analysis of Variance (ANOVA)||||= 0.029
72439511|NCT03926039|144393068|EQUIVALENCE|Equivalence Analysis||||||0.05|||||||ANOVA|||Both group of average difference (95% CI) in intervention group and control group||||0.05
72439512|NCT04247074|144393101|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
72439513|NCT04247074|144393102|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
72439514|NCT04247074|144393103|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
72439515|NCT04247074|144393104|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
72439516|NCT02528188|144393151|SUPERIORITY||Risk Difference (RD)|2.39||||0.0123|TWO_SIDED|95.0|0.58|4.68|||Exact methods for risk difference|||||4.68|0.58|0.0123
72439517|NCT02528188|144393151|SUPERIORITY||Risk Difference (RD)|5.61|||<|0.0001|TWO_SIDED|95.0|3.55|8.14|||Exact methods for risk difference|||||8.14|3.55|<0.0001
72439518|NCT02528188|144393152|SUPERIORITY||Rate Difference|23.5||||0.0012|TWO_SIDED|95.0|9.3|37.7|||Poisson model for rate difference|||||37.7|9.3|0.0012
72439519|NCT02528188|144393152|SUPERIORITY||Rate Difference|56.7|||<|0.0001|TWO_SIDED|95.0|38.4|74.9|||Poisson model for rate difference|||||74.9|38.4|<0.0001
72439520|NCT02528188|144393153|SUPERIORITY|A graphical testing procedure was applied to maintain Type I error. Tanezumab 5 mg versus NSAID was tested first and if all primary endpoints were found significant, then the testing was continued for Tanezumab 2.5 mg versus NSAID and the key secondary endpoint (\>=50% reduction from baseline in WOMAC Pain at Week 16). Primary endpoints were tested sequentially within a dose in order of WOMAC pain, WOMAC physical function, and PGA.|LS Mean Difference|-0.26|STANDARD_ERROR_OF_MEAN|0.11||0.0148|TWO_SIDED|95.0|-0.46|-0.05||Threshold for significance at 0.05 level.|ANCOVA|||Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain subscale and baseline diary average pain as covariates, and study site as a random effect.||-0.05|-0.46|0.0148
72439521|NCT02528188|144393153|SUPERIORITY|A graphical testing procedure was applied to maintain Type I error. Tanezumab 5 mg versus NSAID was tested first and if all primary endpoints were found significant, then the testing was continued for Tanezumab 2.5 mg versus NSAID and the key secondary endpoint (\>=50% reduction from baseline in WOMAC Pain at Week 16). Primary endpoints were tested sequentially within a dose in order of WOMAC pain, WOMAC physical function, and PGA.|LS Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.11||0.1597|TWO_SIDED|95.0|-0.36|0.06||Threshold for significance at 0.05 level.|ANCOVA|||Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. Analysis of covariance (ANCOVA) model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain subscale and baseline diary average pain as covariates, and study site as a random effect.||0.06|-0.36|0.1597
72495666|NCT04871711|144520650|SUPERIORITY||Risk Difference (RD)|10.4|||<|0.001|TWO_SIDED|95.0|5.3|15.6||Evaluated at 4% significance level (two-sided) using hierarchical tests, alpha splitting and alpha recycling controlling overall type 1 error at 5% (two-sided).|Cochran-Mantel-Haenszel|Stratified by region and baseline IGA-CHE score.|Mantel-Haenszel risk difference, stratified by region and baseline IGA-CHE score.|Based on the primary analysis of the primary estimand 'composite'. Subjects with missing data, subjects who received rescue treatment, or subjects who permanently discontinued IMP were considered non-responders.||15.6|5.3|<0.001
72504656|NCT02495077|144540085|SUPERIORITY||Mean Difference (Final Values)|-1.03||||0.639|TWO_SIDED|95.0|-5.37|3.3|||Mixed Models Analysis|||Day 7. Mean eGFR of the two treatment groups was compared. The p-value, estimated day 7 eGFR within each treatment group, estimate of the treatment group difference, and estimated 95% confidence interval result from a repeated measures mixed model using available eGFR data from day 7 and months 1, 3, 6, 12, 18, and 24 to compare the experimental group to the control group at day 7. Random effects for the intercept and eGFR collection day were utilized in the model.||3.30|-5.37|0.639
72386910|NCT03855228|144282014|SUPERIORITY||||||<|0.01|||||||ANOVA|||This analysis compares Change From Baseline values.||||<0.01
72386911|NCT03855228|144282014|SUPERIORITY|||||||0.02|||||||ANOVA|||This analysis compares Change From Baseline values.||||0.02
72386912|NCT03855228|144282015|SUPERIORITY|||||||0.35|||||||ANOVA|||This analysis compares Change From Baseline values.||||0.35
72386913|NCT03855228|144282015|SUPERIORITY||||||<|0.01|||||||ANOVA|||This analysis compares Change From Baseline values.||||<0.01
72386914|NCT03855228|144282015|SUPERIORITY||||||<|0.01|||||||ANOVA|||This analysis compares Change From Baseline values.||||<0.01
72386915|NCT03855228|144282015|SUPERIORITY|||||||0.03|||||||ANOVA|||This analysis compares Change From Baseline values.||||0.03
72386916|NCT03855228|144282015|SUPERIORITY||||||<|0.01|||||||ANOVA|||This analysis compares Change From Baseline values.||||<0.01
72386917|NCT03855228|144282015|SUPERIORITY|||||||0.02|||||||ANOVA|||This analysis compares Change From Baseline values.||||0.02
72386918|NCT03855228|144282016|SUPERIORITY|||||||0.77|||||||ANOVA|||This analysis compares Change From Baseline values.||||0.77
72386919|NCT03855228|144282016|SUPERIORITY||||||<|0.01|||||||ANOVA|||This analysis compares Change From Baseline values.||||<0.01
72386920|NCT03855228|144282016|SUPERIORITY||||||<|0.01|||||||ANOVA|||This analysis compares Change From Baseline values.||||<0.01
72386921|NCT03855228|144282016|SUPERIORITY||||||<|0.01|||||||ANOVA|||This analysis compares Change From Baseline values.||||<0.01
72386922|NCT03855228|144282016|SUPERIORITY||||||<|0.01|||||||ANOVA|||This analysis compares Change From Baseline values.||||<0.01
72386923|NCT03855228|144282016|SUPERIORITY|||||||0.45|||||||ANOVA|||This analysis compares Change From Baseline values.||||0.45
72386924|NCT03855228|144282017|SUPERIORITY|||||||0.99|||||||ANOVA|||This analysis compares Change From Baseline values.||||0.99
72386925|NCT03855228|144282017|SUPERIORITY||||||<|0.01|||||||ANOVA|||This analysis compares Change From Baseline values.||||<0.01
72386926|NCT03855228|144282017|SUPERIORITY||||||<|0.01|||||||ANOVA|||This analysis compares Change From Baseline values.||||<0.01
72386927|NCT03855228|144282017|SUPERIORITY||||||<|0.01|||||||ANOVA|||This analysis compares Change From Baseline values.||||<0.01
72386928|NCT03855228|144282017|SUPERIORITY||||||<|0.01|||||||ANOVA|||This analysis compares Change From Baseline values.||||<0.01
72386929|NCT03855228|144282017|SUPERIORITY|||||||0.08|||||||ANOVA|||This analysis compares Change From Baseline values.||||0.08
72386930|NCT03855228|144282018|SUPERIORITY|||||||0.85|||||||ANOVA|||This analysis compares Change From Baseline values.||||0.85
72386931|NCT03855228|144282018|SUPERIORITY||||||<|0.01|||||||ANOVA|||This analysis compares Change From Baseline values.||||<0.01
72386932|NCT03855228|144282018|SUPERIORITY||||||<|0.01|||||||ANOVA|||This analysis compares Change From Baseline values.||||<0.01
72386933|NCT03855228|144282018|SUPERIORITY||||||<|0.01|||||||ANOVA|||This analysis compares Change From Baseline values.||||<0.01
72386934|NCT03855228|144282018|SUPERIORITY||||||<|0.01|||||||ANOVA|||This analysis compares Change From Baseline values.||||<0.01
72386935|NCT03855228|144282018|SUPERIORITY|||||||0.17|||||||ANOVA|||This analysis compares Change From Baseline values.||||0.17
72386936|NCT03855228|144282019|SUPERIORITY|||||||0.88|||||||ANOVA|||This analysis compares Change From Baseline values.||||0.88
72386937|NCT03855228|144282019|SUPERIORITY||||||<|0.01|||||||ANOVA|||This analysis compares Change From Baseline values.||||<0.01
72386938|NCT03855228|144282019|SUPERIORITY||||||<|0.01|||||||ANOVA|||This analysis compares Change From Baseline values.||||<0.01
72386939|NCT03855228|144282019|SUPERIORITY||||||<|0.01|||||||ANOVA|||This analysis compares Change From Baseline values.||||<0.01
72386940|NCT03855228|144282019|SUPERIORITY||||||<|0.01|||||||ANOVA|||This analysis compares Change From Baseline values.||||<0.01
72386941|NCT03855228|144282019|SUPERIORITY|||||||0.22|||||||ANOVA|||This analysis compares Change From Baseline values.||||0.22
72386942|NCT03855228|144282020|SUPERIORITY|||||||0.65|||||||ANOVA|||This analysis compares Change From Baseline values.||||0.65
72386943|NCT03855228|144282020|SUPERIORITY||||||<|0.01|||||||ANOVA|||This analysis compares Change From Baseline values.||||<0.01
72386944|NCT03855228|144282020|SUPERIORITY||||||<|0.01|||||||ANOVA|||This analysis compares Change From Baseline values.||||<0.01
72386945|NCT03855228|144282020|SUPERIORITY||||||<|0.01|||||||ANOVA|||This analysis compares Change From Baseline values.||||<0.01
72386946|NCT03855228|144282020|SUPERIORITY||||||<|0.01|||||||ANOVA|||This analysis compares Change From Baseline values.||||<0.01
72386947|NCT03855228|144282020|SUPERIORITY|||||||0.92|||||||ANOVA|||This analysis compares Change From Baseline values.||||0.92
72386948|NCT03855228|144282021|SUPERIORITY|||||||0.95|||||||ANOVA|||This analysis compares Change From Baseline values.||||0.95
72386949|NCT03855228|144282021|SUPERIORITY|||||||0.01|||||||ANOVA|||This analysis compares Change From Baseline values.||||0.01
72386950|NCT03855228|144282021|SUPERIORITY||||||<|0.01|||||||ANOVA|||This analysis compares Change From Baseline values.||||<0.01
72386951|NCT03855228|144282021|SUPERIORITY|||||||0.01|||||||ANOVA|||This analysis compares Change From Baseline values.||||0.01
72558926|NCT01243151|144647850|SUPERIORITY_OR_OTHER||LS Mean Difference|5.98|STANDARD_ERROR_OF_MEAN|5.258||0.2601|TWO_SIDED|95.0|-4.54|16.5|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||16.50|-4.54|0.2601
72439522|NCT02528188|144393154|SUPERIORITY|A graphical testing procedure was applied to maintain Type I error. Tanezumab 5 mg versus NSAID was tested first and if all primary endpoints were found significant, then the testing was continued for Tanezumab 2.5 mg versus NSAID and the key secondary endpoint (\>=50% reduction from baseline in WOMAC Pain at Week 16). Primary endpoints were tested sequentially within a dose in order of WOMAC pain, WOMAC physical function, and PGA.|LS Mean Difference|-0.31|STANDARD_ERROR_OF_MEAN|0.1||0.003|TWO_SIDED|95.0|-0.52|-0.11||Threshold for significance at 0.05 level.|ANCOVA|||Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariates, and study site as a random effect.||-0.11|-0.52|0.0030
72558927|NCT01243151|144647850|SUPERIORITY_OR_OTHER||LS Mean Difference|9.96|STANDARD_ERROR_OF_MEAN|5.132||0.057|TWO_SIDED|95.0|-0.31|20.24|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||20.24|-0.31|0.0570
72439523|NCT02528188|144393154|SUPERIORITY|A graphical testing procedure was applied to maintain Type I error. Tanezumab 5 mg versus NSAID was tested first and if all primary endpoints were found significant, then the testing was continued for Tanezumab 2.5 mg versus NSAID and the key secondary endpoint (\>=50% reduction from baseline in WOMAC Pain at Week 16). Primary endpoints were tested sequentially within a dose in order of WOMAC pain, WOMAC physical function, and PGA.|LS Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.11||0.0691|TWO_SIDED|95.0|-0.4|0.02||Threshold for significance at 0.05 level.|ANCOVA|||Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariates, and study site as a random effect.||0.02|-0.40|0.0691
72439524|NCT02528188|144393155|SUPERIORITY|A graphical testing procedure was applied to maintain Type I error. Tanezumab 5 mg versus NSAID was tested first and if all primary endpoints were found significant, then the testing was continued for Tanezumab 2.5 mg versus NSAID and the key secondary endpoint (\>=50% reduction from baseline in WOMAC Pain at Week 16). Primary endpoints were tested sequentially within a dose in order of WOMAC pain, WOMAC physical function, and PGA.|LS Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.04||0.3431|TWO_SIDED|95.0|-0.11|0.04||Threshold for significance at 0.05 level.|ANCOVA|||Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline PGA and baseline diary average pain as covariates, and study site as a random effect.||0.04|-0.11|0.3431
72439525|NCT02528188|144393155|SUPERIORITY|A graphical testing procedure was applied to maintain Type I error. Tanezumab 5 mg versus NSAID was tested first and if all primary endpoints were found significant, then the testing was continued for Tanezumab 2.5 mg versus NSAID and the key secondary endpoint (\>=50% reduction from baseline in WOMAC Pain at Week 16). Primary endpoints were tested sequentially within a dose in order of WOMAC pain, WOMAC physical function, and PGA.|LS Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.04||0.6332|TWO_SIDED|95.0|-0.09|0.06||Threshold for significance at 0.05 level.|ANCOVA|||Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline PGA and baseline diary average pain as covariates, and study site as a random effect.||0.06|-0.09|0.6332
72439526|NCT02528188|144393156|SUPERIORITY||Risk Difference (RD)|0.5||||0.4082|TWO_SIDED|95.0|-0.75|2.28|||Exact methods for risk difference|||||2.28|-0.75|0.4082
72439527|NCT02528188|144393156|SUPERIORITY||Risk Difference (RD)|1.7||||0.0238|TWO_SIDED|95.0|0.31|3.63|||Exact methods for risk difference|||||3.63|0.31|0.0238
72439528|NCT02528188|144393157|SUPERIORITY||Rate Difference|4.8||||0.2035|TWO_SIDED|95.0|-2.6|12.2|||Poisson model for rate difference|||||12.2|-2.6|0.2035
72439529|NCT02528188|144393157|SUPERIORITY||Rate Difference|16.9||||0.001|TWO_SIDED|95.0|6.8|27.0|||Poisson model for rate difference|||||27.0|6.8|0.0010
72439530|NCT02528188|144393158|SUPERIORITY||Risk Difference|1.99||||0.0248|TWO_SIDED|95.0|0.31|4.17|||Exact methods for risk difference|||Rapidly progressive OA Type 1 or 2||4.17|0.31|0.0248
72439531|NCT02528188|144393158|SUPERIORITY||Risk difference|5.11|||<|0.0001|TWO_SIDED|95.0|3.16|7.54|||Exact methods for risk difference|||Rapidly Progressive OA Type 1 or 2||7.54|3.16|<0.0001
72439532|NCT02528188|144393158|SUPERIORITY||Risk difference|1.79||||0.0366|TWO_SIDED|95.0|0.16|3.92|||Exact methods for risk difference|||Rapidly Progressive OA Type 1||3.92|0.16|0.0366
72439533|NCT02528188|144393158|SUPERIORITY||Risk difference|3.81||||0.0001|TWO_SIDED|95.0|1.99|6.12|||Exact methods for risk difference|||Rapidly Progressive OA Type 1||6.12|1.99|0.0001
72439534|NCT02528188|144393158|SUPERIORITY||Risk difference|0.2||||0.6168|TWO_SIDED|95.0|-0.76|1.71|||Exact methods for risk difference|||Rapidly Progressive OA Type 2||1.71|-0.76|0.6168
72439535|NCT02528188|144393158|SUPERIORITY||Risk difference|1.3||||0.0388|TWO_SIDED|95.0|0.17|2.97|||Exact methods for risk difference|||Rapidly Progressive OA Type 2||2.97|0.17|0.0388
72439536|NCT02528188|144393158|SUPERIORITY||Risk difference|0.1||||0.7245|TWO_SIDED|95.0|-0.74|1.51|||Exact methods for risk difference|||Primary osteonecrosis||1.51|-0.74|0.7245
72558928|NCT01243151|144647851|SUPERIORITY_OR_OTHER||LS Mean Difference|-32.88|STANDARD_ERROR_OF_MEAN|5.008|<|0.0001|TWO_SIDED|95.0|-42.93|-22.84|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-22.84|-42.93|<0.0001
72439537|NCT02528188|144393158|SUPERIORITY||Risk difference|0.1||||0.7182|TWO_SIDED|95.0|-0.74|1.52|||Exact methods for risk difference|||Primary osteonecrosis||1.52|-0.74|0.7182
72439538|NCT02528188|144393158|SUPERIORITY||Risk difference|0.2||||0.6824|TWO_SIDED|95.0|-0.96|1.9|||Exact methods for risk difference|||Subchondral insufficiency fracture||1.90|-0.96|0.6824
72439539|NCT02528188|144393158|SUPERIORITY||Risk difference|0.3||||0.5632|TWO_SIDED|95.0|-0.86|2.03|||Exact methods for risk difference|||Subchondral insufficiency fracture||2.03|-0.86|0.5632
72439540|NCT02528188|144393159|SUPERIORITY||Rate Difference|19.56||||0.0027|TWO_SIDED|95.0|6.78|32.35|||Poisson model for rate difference|||Rapidly Progressive OA Type 1 or 2||32.35|6.78|0.0027
72439541|NCT02528188|144393159|SUPERIORITY||Rate Difference|51.48|||<|0.0001|TWO_SIDED|95.0|34.47|68.5|||Poisson model for rate difference|||Rapidly Progressive OA Type 1 or 2||68.50|34.47|<0.0001
72439542|NCT02528188|144393159|SUPERIORITY||Rate Difference|17.58||||0.0047|TWO_SIDED|95.0|5.39|29.76|||Poisson model for rate difference|||Rapidly Progressive OA Type 1||29.76|5.39|0.0047
72439543|NCT02528188|144393159|SUPERIORITY||Rate Difference|38.22|||<|0.0001|TWO_SIDED|95.0|23.05|53.4|||Poisson model for rate difference|||Rapidly Progressive OA Type 1||53.40|23.05|<0.0001
72439544|NCT02528188|144393159|SUPERIORITY||Rate Difference|1.94||||0.3214|TWO_SIDED|95.0|-1.89|5.76|||Poisson model for rate difference|||Rapidly Progressive OA Type 2||5.76|-1.89|0.3214
72558929|NCT01243151|144647851|SUPERIORITY_OR_OTHER||LS Mean Difference|-30.8|STANDARD_ERROR_OF_MEAN|5.26|<|0.0001|TWO_SIDED|95.0|-41.34|-20.26|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-20.26|-41.34|<0.0001
72439545|NCT02528188|144393159|SUPERIORITY||Rate Difference|12.88||||0.0008|TWO_SIDED|95.0|5.36|20.39|||Poisson model for rate difference|||Rapidly Progressive OA Type 2||20.39|5.36|0.0008
72439546|NCT02528188|144393159|SUPERIORITY||Rate Difference|1.9||||0.5394|TWO_SIDED|95.0|-4.17|7.96|||Poisson model for rate difference|||Subchondral Insufficiency Fracture||7.96|-4.17|0.5394
72439547|NCT02528188|144393159|SUPERIORITY||Rate Difference|2.98||||0.3636|TWO_SIDED|95.0|-3.44|9.39|||Poisson model for rate difference|||Subchondral Insufficiency Fracture||9.39|-3.44|0.3636
72439548|NCT02528188|144393159|SUPERIORITY||Poisson model for rate difference|1.0|||||||||||||95% CI was not estimable since there were less number of participants with events.|Primary osteonecrosis||||
72439549|NCT02528188|144393159|SUPERIORITY||Rate Difference|1.0|||||||||||||95% CI was not estimable since there were less number of participants with events.|Primary osteonecrosis||||
72439550|NCT02528188|144393160|SUPERIORITY||Risk Difference (RD)|4.87||||0.0002|TWO_SIDED|95.0|2.43|7.74||The event of adjudicated primary osteonecrosis in the tanezumab 2.5 mg treatment group is not included in this analysis. Conclusions for this analysis do not change as the comparison to NSAID is already statistically significant in favor of NSAID.|Exact methods for risk difference|||||7.74|2.43|0.0002
72439551|NCT02528188|144393160|SUPERIORITY||Risk Difference (RD)|9.41|||<|0.0001|TWO_SIDED|95.0|6.73|12.52|||Exact methods for risk difference|||||12.52|6.73|<0.0001
72439552|NCT02528188|144393161|SUPERIORITY||Rate Difference|48.25|||<|0.0001|TWO_SIDED|95.0|26.76|69.74||The event of adjudicated primary osteonecrosis in the tanezumab 2.5 mg treatment group is not included in this analysis. Conclusions for this analysis do not change as the comparison to NSAID is already statistically significant in favor of NSAID.|Poisson model for rate difference|||||69.74|26.76|<0.0001
72439553|NCT02528188|144393161|SUPERIORITY||Rate Difference|95.83|||<|0.0001|TWO_SIDED|95.0|70.25|121.42|||Poisson model for rate difference|||||121.42|70.25|<0.0001
72439554|NCT02528188|144393162|SUPERIORITY||LS Mean Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.04||0.0979|TWO_SIDED|95.0|-0.15|0.01|||ANCOVA|||Change in medial JSW width at Week 56: ANCOVA model included treatment, baseline JSW as covariate, and study site as a random effect.||0.01|-0.15|0.0979
72439555|NCT02528188|144393162|SUPERIORITY||LS Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.04|<|0.0001|TWO_SIDED|95.0|-0.24|-0.08|||ANCOVA|||Change in medial JSW at Week 56: ANCOVA model included treatment, baseline JSW as covariate, and study site as a random effect.||-0.08|-0.24|<0.0001
72439556|NCT02528188|144393162|SUPERIORITY||LS Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.05||0.1162|TWO_SIDED|95.0|-0.17|0.02|||ANCOVA|||Change in medial JSW at Week 80: ANCOVA model included treatment, baseline JSW as covariate, and study site as a random effect.||0.02|-0.17|0.1162
72439557|NCT02528188|144393162|SUPERIORITY||LS Mean Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.05||0.0128|TWO_SIDED|95.0|-0.22|-0.03|||ANCOVA|||Change in medial JSW at Week 80: ANCOVA model included treatment, baseline JSW as covariate, and study site as a random effect.||-0.03|-0.22|0.0128
72439558|NCT02528188|144393162|SUPERIORITY||LS Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.09||0.8885|TWO_SIDED|95.0|-0.17|0.2|||ANCOVA|||Change in lateral JSW at Week 56: ANCOVA model included treatment, baseline JSW as covariate, and study site as a random effect.||0.20|-0.17|0.8885
72439559|NCT02528188|144393162|SUPERIORITY||LS Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.1||0.6345|TWO_SIDED|95.0|-0.24|0.15|||ANCOVA|||Change in lateral JSW at Week 56: ANCOVA model included treatment, baseline JSW as covariate, and study site as a random effect.||0.15|-0.24|0.6345
72439560|NCT02528188|144393162|SUPERIORITY||LS Mean Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.12||0.4406|TWO_SIDED|95.0|-0.32|0.14|||ANCOVA|||Change in lateral JSW at Week 80: ANCOVA model included treatment, baseline JSW as covariate, and study site as a random effect.||0.14|-0.32|0.4406
72439561|NCT02528188|144393162|SUPERIORITY||LS Mean Difference|0.05|STANDARD_ERROR_OF_MEAN|0.12||0.7109|TWO_SIDED|95.0|-0.19|0.28|||ANCOVA|||Change in lateral JSW at Week 80: ANCOVA model included treatment, baseline JSW as covariate, and study site as a random effect.||0.28|-0.19|0.7109
72439562|NCT02528188|144393163|SUPERIORITY||LS Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.08||0.102|TWO_SIDED|95.0|-0.3|0.03|||ANCOVA|||Change at Week 56: ANCOVA model included treatment, baseline JSW as covariate, and study site as a random effect.||0.03|-0.30|0.1020
72439563|NCT02528188|144393163|SUPERIORITY||LS Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.08||0.023|TWO_SIDED|95.0|-0.35|-0.03|||ANCOVA|||Change at Week 56: ANCOVA model included treatment, baseline JSW as covariate, and study site as a random effect.||-0.03|-0.35|0.0230
72439564|NCT02528188|144393163|SUPERIORITY||LS Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.1||0.0645|TWO_SIDED|95.0|-0.37|0.01|||ANCOVA|||Change at Week 80: ANCOVA model included treatment, baseline JSW as covariate, and study site as a random effect.||0.01|-0.37|0.0645
72439565|NCT02528188|144393163|SUPERIORITY||LS Mean Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.1||0.5005|TWO_SIDED|95.0|-0.26|0.13|||ANCOVA|||Change at Week 80: ANCOVA model included treatment, baseline JSW as covariate, and study site as a random effect.||0.13|-0.26|0.5005
72439566|NCT02528188|144393164|SUPERIORITY||Odds Ratio (OR)|1.85||||0.0358|TWO_SIDED|95.0|1.04|3.29|||Regression, Logistic|||Decrease in medial JSW at Week 56: Logistic regression model included treatment, and baseline JSW as covariate.||3.29|1.04|0.0358
72439567|NCT02528188|144393164|SUPERIORITY||Odds Ratio (OR)|2.37||||0.0021|TWO_SIDED|95.0|1.37|4.12|||Regression, Logistic|||Decrease in medial JSW at Week 56: Logistic regression model included treatment, and baseline JSW as covariate.||4.12|1.37|0.0021
72439568|NCT02528188|144393164|SUPERIORITY||Odds Ratio (OR)|2.01||||0.0301|TWO_SIDED|95.0|1.07|3.77|||Regression, Logistic|||Decrease in medial JSW at Week 80: Logistic regression model included treatment, and baseline JSW as covariate.||3.77|1.07|0.0301
72618994|NCT03615534|144768404|SUPERIORITY|||||||0.334||||||Results were evaluated in terms of adjusted end line d-LDL-C levels, embracing the least significant difference (LSD) for pair-wise comparison. Probability of less than 0.05 was considered statistically significant.|MANCOVA|Covariates appearing in MANCOVA model are evaluated at the following baseline values: d-LDL-C= 119.1 mg/dl.TC=199.9 mg/dl, Non HDL-C= 168.0 mg/dl,||Multivariate Analysis of Covariance (MANCOVA), was applied to assess treatment effects among different arms, comprising the influence of the baseline d-LDL-C level as a covariate, with further adjustments for baseline TC and Non HDL-C .||||0.334
72439569|NCT02528188|144393164|SUPERIORITY||Odds Ratio (OR)|2.65||||0.0016|TWO_SIDED|95.0|1.45|4.85|||Regression, Logistic|||Decrease in medial JSW at Week 80: Logistic regression model included treatment, and baseline JSW as covariate.||4.85|1.45|0.0016
72439570|NCT02528188|144393164|SUPERIORITY||Odds Ratio (OR)|0.55||||0.3002|TWO_SIDED|95.0|0.18|1.7|||Regression, Logistic|||Decrease in lateral JSW at Week 56: Logistic regression model included treatment, and baseline JSW as covariate.||1.70|0.18|0.3002
72439571|NCT02528188|144393164|SUPERIORITY||Odds Ratio (OR)|1.07||||0.8997|TWO_SIDED|95.0|0.39|2.89|||Regression, Logistic|||Decrease in lateral JSW at Week 56: Logistic regression model included treatment, and baseline JSW as covariate.||2.89|0.39|0.8997
72439572|NCT02528188|144393164|SUPERIORITY||Odds Ratio (OR)|1.48||||0.4559|TWO_SIDED|95.0|0.53|4.18|||Regression, Logistic|||Decrease in lateral JSW at Week 80: Logistic regression model included treatment, and baseline JSW as covariate.||4.18|0.53|0.4559
72439573|NCT02528188|144393164|SUPERIORITY||Odds Ratio (OR)|0.71||||0.5996|TWO_SIDED|95.0|0.2|2.54|||Regression, Logistic|||Decrease in lateral JSW at Week 80: Logistic regression model included treatment, and baseline JSW as covariate.||2.54|0.20|0.5996
72439574|NCT02528188|144393165|SUPERIORITY||Odds Ratio (OR)|3.37||||0.0714|TWO_SIDED|95.0|0.9|12.65|||Regression, Logistic|||Decrease at Week 56: Logistic regression model included treatment, and baseline JSW as covariate||12.65|0.90|0.0714
72439575|NCT02528188|144393165|SUPERIORITY||Odds Ratio (OR)|3.42||||0.0681|TWO_SIDED|95.0|0.91|12.84|||Regression, Logistic|||Decrease at Week 56: Logistic regression model included treatment, and baseline JSW as covariate||12.84|0.91|0.0681
72439576|NCT02528188|144393165|SUPERIORITY||Odds Ratio (OR)|3.12||||0.0967|TWO_SIDED|95.0|0.81|11.95|||Regression, Logistic|||Decrease at Week 80: Logistic regression model included treatment, and baseline JSW as covariate||11.95|0.81|0.0967
72439577|NCT02528188|144393165|SUPERIORITY||Odds Ratio (OR)|3.11||||0.0976|TWO_SIDED|95.0|0.81|11.9|||Regression, Logistic|||Decrease at Week 80: Logistic regression model included treatment, and baseline JSW as covariate||11.90|0.81|0.0976
72558930|NCT01243151|144647851|SUPERIORITY_OR_OTHER||LS Mean Difference|-39.98|STANDARD_ERROR_OF_MEAN|5.088|<|0.0001|TWO_SIDED|95.0|-50.18|-29.77|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-29.77|-50.18|<0.0001
72558931|NCT01243151|144647851|SUPERIORITY_OR_OTHER||LS Mean Difference|-38.37|STANDARD_ERROR_OF_MEAN|5.07|<|0.0001|TWO_SIDED|95.0|-48.54|-28.2|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-28.20|-48.54|<0.0001
72558932|NCT01243151|144647851|SUPERIORITY_OR_OTHER||LS Mean Difference|-42.18|STANDARD_ERROR_OF_MEAN|6.271|<|0.0001|TWO_SIDED|95.0|-54.73|-29.63|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-29.63|-54.73|<0.0001
72386952|NCT03855228|144282021|SUPERIORITY||||||<|0.01|||||||ANOVA|||This analysis compares Change From Baseline values.||||<0.01
72386953|NCT03855228|144282021|SUPERIORITY|||||||0.58|||||||ANOVA|||This analysis compares Change From Baseline values.||||0.58
72386954|NCT03855228|144282022|SUPERIORITY|||||||0.29|||||||ANOVA|||||||0.29
72386955|NCT03855228|144282022|SUPERIORITY||||||<|0.01|||||||ANOVA|||||||<0.01
72386956|NCT03855228|144282022|SUPERIORITY||||||<|0.01|||||||ANOVA|||||||<0.01
72386957|NCT03855228|144282022|SUPERIORITY||||||<|0.01|||||||ANOVA|||||||<0.01
72386958|NCT03855228|144282022|SUPERIORITY||||||<|0.01|||||||ANOVA|||||||<0.01
72386959|NCT03855228|144282022|SUPERIORITY|||||||0.8|||||||ANOVA|||||||0.80
72386960|NCT03855228|144282023|SUPERIORITY|||||||0.41|||||||ANOVA|||||||0.41
72386961|NCT03855228|144282023|SUPERIORITY||||||<|0.01|||||||ANOVA|||||||<0.01
72386962|NCT03855228|144282023|SUPERIORITY||||||<|0.01|||||||ANOVA|||||||<0.01
72439578|NCT02528188|144393166|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.08||0.2212|TWO_SIDED|95.0|-0.27|0.06|||ANCOVA|||Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain subscale and baseline diary average pain as covariates, and study site as a random effect.||0.06|-0.27|0.2212
72439579|NCT02528188|144393166|SUPERIORITY||LS Mean Difference|0.06|STANDARD_ERROR_OF_MEAN|0.08||0.4557|TWO_SIDED|95.0|-0.1|0.23|||ANCOVA|||Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain subscale and baseline diary average pain as covariates, and study site as a random effect.||0.23|-0.10|0.4557
72495667|NCT04871711|144520651|SUPERIORITY||Risk Difference (RD)|21.0|||<|0.001|TWO_SIDED|95.0|12.6|29.4||Evaluated at 4% significance level (two-sided) using hierarchical tests, alpha splitting and alpha recycling controlling overall type 1 error at 5% (two-sided).|Cochran-Mantel-Haenszel|Stratified by region and baseline IGA-CHE score.|Mantel-Haenszel risk difference, stratified by region and baseline IGA-CHE score.|Based on the primary analysis of the primary estimand 'composite'. Subjects with missing data, subjects who received rescue treatment, or subjects who permanently discontinued IMP were considered non-responders.||29.4|12.6|<0.001
72495668|NCT04871711|144520652|SUPERIORITY||Risk Difference (RD)|19.5|||<|0.001|TWO_SIDED|95.0|12.5|26.5||Evaluated at 4% significance level (two-sided) using hierarchical tests, alpha splitting and alpha recycling controlling overall type 1 error at 5% (two-sided).|Cochran-Mantel-Haenszel|Stratified by region and baseline IGA-CHE score.|Mantel-Haenszel risk difference, stratified by region and baseline IGA-CHE score.|Based on the primary analysis of the primary estimand 'composite'. Subjects with missing data, subjects who received rescue treatment, or subjects who permanently discontinued IMP were considered non-responders.||26.5|12.5|<0.001
72495669|NCT04871711|144520653|SUPERIORITY||Risk Difference (RD)|9.3||||0.004|TWO_SIDED|95.0|3.8|14.7||Evaluated at 4% significance level (two-sided) using hierarchical tests, alpha splitting and alpha recycling controlling overall type 1 error at 5% (two-sided).|Cochran-Mantel-Haenszel|Stratified by region and baseline IGA-CHE score.|Mantel-Haenszel risk difference, stratified by region and baseline IGA-CHE score.|Based on the primary analysis of the primary estimand 'composite'. Subjects with missing data, subjects who received rescue treatment, or subjects who permanently discontinued IMP were considered non-responders.||14.7|3.8|0.004
72495670|NCT04871711|144520654|SUPERIORITY||Risk Difference (RD)|22.5|||<|0.001|TWO_SIDED|95.0|14.4|30.6||Evaluated at 4% significance level (two-sided) using hierarchical tests, alpha splitting and alpha recycling controlling overall type 1 error at 5% (two-sided).|Cochran-Mantel-Haenszel|Stratified by region and baseline IGA-CHE score.|Mantel-Haenszel risk difference, stratified by region and baseline IGA-CHE score.|Based on the primary analysis of the primary estimand 'composite'. Subjects with missing data, subjects who received rescue treatment, or subjects who permanently discontinued IMP were considered non-responders.||30.6|14.4|<0.001
72495671|NCT04871711|144520655|SUPERIORITY||Risk Difference (RD)|19.5|||<|0.001|TWO_SIDED|95.0|12.5|26.5||Evaluated at 4% significance level (two-sided) using hierarchical tests, alpha splitting and alpha recycling controlling overall type 1 error at 5% (two-sided).|Cochran-Mantel-Haenszel|Stratified by region and baseline IGA-CHE score.|Mantel-Haenszel risk difference, stratified by region and baseline IGA-CHE score.|Based on the primary analysis of the primary estimand 'composite'. Subjects with missing data, subjects who received rescue treatment, or subjects who permanently discontinued IMP were considered non-responders.||26.5|12.5|<0.001
72504748|NCT03114969|144540500|SUPERIORITY||Odds Ratio (OR)|2.71||||0.01|TWO_SIDED|95.0|1.274|5.764||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta+\[Relvar Ellipta+LAMA\] as comparator.|||5.764|1.274|0.010
72386963|NCT03855228|144282023|SUPERIORITY||||||<|0.01|||||||ANOVA|||||||<0.01
72386964|NCT03855228|144282023|SUPERIORITY||||||<|0.01|||||||ANOVA|||||||<0.01
72386965|NCT03855228|144282023|SUPERIORITY|||||||0.08|||||||ANOVA|||||||0.08
72386966|NCT01757535|144282028|SUPERIORITY||Hazard Ratio (HR)|0.69||||0.0009|TWO_SIDED|95.0|0.55|0.86||The p-value is 2-sided from a log-rank test stratified by age, cytogenetic risk category, and received consolidation therapy or not.|Log Rank||The hazard ratio is from a Cox proportional hazards model stratified by age, cytogenetic risk category, and received consolidation therapy or not.||The confidence interval (CI) for the difference was derived using Kosorok's method.|0.86|0.55|0.0009
72386967|NCT01757535|144282029|SUPERIORITY||Hazard Ratio (HR)|0.65|||<|0.0001|TWO_SIDED|95.0|0.52|0.8||The p-value is 2-sided from a log-rank test stratified by age, cytogenetic risk category, and received consolidation therapy or not.|Log Rank||The hazard ratio is from a Cox proportional hazards model stratified by age, cytogenetic risk category, and received consolidation therapy or not.|||0.80|0.52|< 0.0001
72386968|NCT01757535|144282035|SUPERIORITY||Hazard Ratio (HR)|0.9345||||0.7522|TWO_SIDED|95.0|0.6136|1.4231||Stratification factors: • Age (at induction therapy): 55 to 64 years and ≥ 65 years • Prior history of MDS: yes/no • Cytogenetic risk (at induction therapy): intermediate-risk/poor-risk • Received consolidation therapy following induction: yes/no|Regression, Cox|||||1.4231|0.6136|0.7522
72386969|NCT05764408|144282038|SUPERIORITY||Risk Ratio (RR)|0.81|||||TWO_SIDED|95.0|0.49|1.35||||||||1.35|0.49|
72386970|NCT05764408|144282039|SUPERIORITY||Risk Ratio (RR)|0.86|||||TWO_SIDED|95.0|0.39|1.86||||||||1.86|0.39|
72386971|NCT05764408|144282040|SUPERIORITY|||||||0.47|||||||t-test, 2 sided|||||||0.47
72386972|NCT05764408|144282042|SUPERIORITY|||||||0.81|||||||t-test, 2 sided|||||||0.81
72386973|NCT05764408|144282043|SUPERIORITY||Risk Ratio (RR)|1.03|||||TWO_SIDED|95.0|0.07|16.12||||||||16.12|0.07|
72386974|NCT05147428|144282046|SUPERIORITY||Cox Proportional Hazard|0.99||||0.76|TWO_SIDED|95.0|0.94|1.04|||Log Rank|||For the primary analysis, we combined all three targeted medication classes (antipsychotics, sedative/hypnotics, or strong anticholinergics). We calculated Kaplan-Meier curves and performed log-rank testing, and estimated hazard ratios using Cox proportional hazards modeling, censoring at death or disenrollment from the health plan, or at the end of the 6-month study observation period, whichever came first. The index date for the survival analysis was the end of the 3-month blackout period.||1.04|0.94|0.76
72386975|NCT05147428|144282047|SUPERIORITY|||||||0.33|||||||Chi-squared|||Secondary outcomes were analyzed only for those patients who were not censored due to health plan disenrollment or death over the 6-month study observation period (n = 10 424). For analyses of secondary outcomes, we compared the 3 arms using chi-square testing for dichotomous outcomes.||||0.33
72386976|NCT05147428|144282048|SUPERIORITY|||||||0.55|||||||Chi-squared|||Secondary outcomes were analyzed only for those patients who were not censored due to health plan disenrollment or death over the 6-month study observation period (n = 10 424). For analyses of secondary outcomes, we compared the 3 arms using chi-square testing for dichotomous outcomes.||||0.55
72558933|NCT01243151|144647851|SUPERIORITY_OR_OTHER||LS Mean Difference|-42.69|STANDARD_ERROR_OF_MEAN|6.512|<|0.0001|TWO_SIDED|95.0|-55.72|-29.67|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-29.67|-55.72|<0.0001
72558934|NCT01243151|144647851|SUPERIORITY_OR_OTHER||LS Mean Difference|-54.56|STANDARD_ERROR_OF_MEAN|6.445|<|0.0001|TWO_SIDED|95.0|-67.45|-41.67|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-41.67|-67.45|<0.0001
72439580|NCT02528188|144393166|SUPERIORITY||LS Mean Difference|-0.27|STANDARD_ERROR_OF_MEAN|0.09||0.0029|TWO_SIDED|95.0|-0.45|-0.09|||ANCOVA|||Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain subscale and baseline diary average pain as covariates, and study site as a random effect.||-0.09|-0.45|0.0029
72439581|NCT02528188|144393166|SUPERIORITY||LS Mean Difference|-0.32|STANDARD_ERROR_OF_MEAN|0.09||0.0005|TWO_SIDED|95.0|-0.5|-0.14|||ANCOVA|||Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain subscale and baseline diary average pain as covariates, and study site as a random effect.||-0.14|-0.50|0.0005
72439582|NCT02528188|144393166|SUPERIORITY||LS Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.09||0.1273|TWO_SIDED|95.0|-0.33|0.04|||ANCOVA|||Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain subscale and baseline diary average pain as covariates, and study site as a random effect.||0.04|-0.33|0.1273
72439583|NCT02528188|144393166|SUPERIORITY||LS Mean Difference|-0.38|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001|TWO_SIDED|95.0|-0.57|-0.2|||ANCOVA|||Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain subscale and baseline diary average pain as covariates, and study site as a random effect.||-0.20|-0.57|<0.0001
72439584|NCT02528188|144393166|SUPERIORITY||LS Mean Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.13||0.6349|TWO_SIDED|95.0|-0.31|0.19|||ANCOVA|||Change at Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain subscale and baseline diary average pain as covariates, and study site as a random effect.||0.19|-0.31|0.6349
72439585|NCT02528188|144393166|SUPERIORITY||LS Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.13||0.1339|TWO_SIDED|95.0|-0.44|0.06|||ANCOVA|||Change at Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain subscale and baseline diary average pain as covariates, and study site as a random effect.||0.06|-0.44|0.1339
72439586|NCT02528188|144393166|SUPERIORITY||LS Mean Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.13||0.6237|TWO_SIDED|95.0|-0.33|0.2|||ANCOVA|||Change at Week 32: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain subscale and baseline diary average pain as covariates, and study site as a random effect.||0.20|-0.33|0.6237
72439587|NCT02528188|144393166|SUPERIORITY||LS Mean Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.13||0.4224|TWO_SIDED|95.0|-0.37|0.16|||ANCOVA|||Change at Week 32: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain subscale and baseline diary average pain as covariates, and study site as a random effect.||0.16|-0.37|0.4224
72439588|NCT02528188|144393166|SUPERIORITY||LS Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.14||0.7526|TWO_SIDED|95.0|-0.31|0.22|||ANCOVA|||Change at Week 40: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain subscale and baseline diary average pain as covariates, and study site as a random effect.||0.22|-0.31|0.7526
72558935|NCT01243151|144647851|SUPERIORITY_OR_OTHER||LS Mean Difference|-51.89|STANDARD_ERROR_OF_MEAN|6.321|<|0.0001|TWO_SIDED|95.0|-64.54|-39.25|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-39.25|-64.54|<0.0001
72439589|NCT02528188|144393166|SUPERIORITY||LS Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.13||0.7328|TWO_SIDED|95.0|-0.31|0.22|||ANCOVA|||Change at Week 40: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain subscale and baseline diary average pain as covariates, and study site as a random effect.||0.22|-0.31|0.7328
72439590|NCT02528188|144393166|SUPERIORITY||LS Mean Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.13||0.5888|TWO_SIDED|95.0|-0.33|0.19|||ANCOVA|||Change at Week 48: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain subscale and baseline diary average pain as covariates, and study site as a random effect.||0.19|-0.33|0.5888
72439591|NCT02528188|144393166|SUPERIORITY||LS Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.14||0.9345|TWO_SIDED|95.0|-0.28|0.26|||ANCOVA|||Change at Week 48: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain subscale and baseline diary average pain as covariates, and study site as a random effect.||0.26|-0.28|0.9345
72439592|NCT02528188|144393166|SUPERIORITY||LS Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.14||0.8782|TWO_SIDED|95.0|-0.29|0.25|||ANCOVA|||Change at Week 56: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain subscale and baseline diary average pain as covariates, and study site as a random effect.||0.25|-0.29|0.8782
72439593|NCT02528188|144393166|SUPERIORITY||LS Mean Difference|0.05|STANDARD_ERROR_OF_MEAN|0.14||0.7076|TWO_SIDED|95.0|-0.22|0.32|||ANCOVA|||Change at Week 56: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain subscale and baseline diary average pain as covariates, and study site as a random effect.||0.32|-0.22|0.7076
72439594|NCT02528188|144393168|SUPERIORITY||LS Mean Difference|-0.21|STANDARD_ERROR_OF_MEAN|0.08||0.015|TWO_SIDED|95.0|-0.37|-0.04|||ANCOVA|||Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariates, and study site as a random effect.||-0.04|-0.37|0.0150
72439595|NCT02528188|144393168|SUPERIORITY||LS Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.08||0.3286|TWO_SIDED|95.0|-0.25|0.08|||ANCOVA|||Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariates, and study site as a random effect.||0.08|-0.25|0.3286
72439596|NCT02528188|144393168|SUPERIORITY||LS Mean Difference|-0.32|STANDARD_ERROR_OF_MEAN|0.09||0.0004|TWO_SIDED|95.0|-0.5|-0.15|||ANCOVA|||Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariates, and study site as a random effect.||-0.15|-0.50|0.0004
72439597|NCT02528188|144393168|SUPERIORITY||LS Mean Difference|-0.35|STANDARD_ERROR_OF_MEAN|0.09||0.0001|TWO_SIDED|95.0|-0.53|-0.17|||ANCOVA|||Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariates, and study site as a random effect.||-0.17|-0.53|0.0001
72439598|NCT02528188|144393168|SUPERIORITY||LS Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.09||0.0517|TWO_SIDED|95.0|-0.37|0.0|||ANCOVA|||Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariates, and study site as a random effect.||0.00|-0.37|0.0517
72558936|NCT01243151|144647851|SUPERIORITY_OR_OTHER||LS Mean Difference|-47.35|STANDARD_ERROR_OF_MEAN|5.359||95|TWO_SIDED|95.0|-58.1|-36.59|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-36.59|-58.10|95
72439599|NCT02528188|144393168|SUPERIORITY||LS Mean Difference|-0.42|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001|TWO_SIDED|95.0|-0.61|-0.23|||ANCOVA|||Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariates, and study site as a random effect.||-0.23|-0.61|<0.0001
72439600|NCT02528188|144393168|SUPERIORITY||LS Mean Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.13||0.3621|TWO_SIDED|95.0|-0.37|0.13|||ANCOVA|||Change at Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariates, and study site as a random effect.||0.13|-0.37|0.3621
72439601|NCT02528188|144393168|SUPERIORITY||LS Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.13||0.0832|TWO_SIDED|95.0|-0.47|0.03|||ANCOVA|||Change at Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariates, and study site as a random effect.||0.03|-0.47|0.0832
72558937|NCT01243151|144647851|SUPERIORITY_OR_OTHER||LS Mean Difference|-51.08|STANDARD_ERROR_OF_MEAN|5.566|<|0.0001|TWO_SIDED|95.0|-62.24|-39.91|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-39.91|-62.24|<0.0001
72558938|NCT01243151|144647851|SUPERIORITY_OR_OTHER||LS Mean Difference|-59.89|STANDARD_ERROR_OF_MEAN|5.482|<|0.0001|TWO_SIDED|95.0|-70.89|-48.89|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-48.89|-70.89|<0.0001
72495672|NCT04871711|144520656|SUPERIORITY||Risk Difference (RD)|21.7|||<|0.001|TWO_SIDED|95.0|12.4|30.9||Evaluated at 4% significance level (two-sided) using hierarchical tests, alpha splitting and alpha recycling controlling overall type 1 error at 5% (two-sided).|Cochran-Mantel-Haenszel|Stratified by region and baseline IGA-CHE score.|Mantel-Haenszel risk difference, stratified by region and baseline IGA-CHE score.|Based on the primary analysis of the primary estimand 'composite'. Subjects with missing data, subjects who received rescue treatment, or subjects who permanently discontinued IMP were considered non-responders.||30.9|12.4|<0.001
72439602|NCT02528188|144393168|SUPERIORITY||LS Mean Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.13||0.4072|TWO_SIDED|95.0|-0.38|0.15|||ANCOVA|||Change at Week 32: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariates, and study site as a random effect.||0.15|-0.38|0.4072
72439603|NCT02528188|144393168|SUPERIORITY||LS Mean Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.13||0.3404|TWO_SIDED|95.0|-0.39|0.13|||ANCOVA|||Change at Week 32: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariates, and study site as a random effect.||0.13|-0.39|0.3404
72618995|NCT03615534|144768404|SUPERIORITY|||||||0.012||||||Results were evaluated in terms of adjusted end line Non HDL-C levels, embracing the least significant difference (LSD) for pair-wise comparison. Probability of less than 0.05 was considered statistically significant.|MANCOVA|Covariates appearing in MANCOVA model are evaluated at the following baseline values: Non HDL-C= 168.0 mg/dl,TC=199.9 mg/dl, d-LDL-C= 119.1 mg/dl.||Multivariate Analysis of Covariance (MANCOVA), was applied to assess treatment effects among different arms, comprising the influence of the baseline Non HDL-C level as a covariate, with further adjustments for baseline TC and d-LDL-C.||||0.012
72439604|NCT02528188|144393168|SUPERIORITY||LS Mean Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.14||0.6344|TWO_SIDED|95.0|-0.34|0.2|||ANCOVA|||Change at Week 40: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariates, and study site as a random effect.||0.20|-0.34|0.6344
72439605|NCT02528188|144393168|SUPERIORITY||LS Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.14||0.5756|TWO_SIDED|95.0|-0.35|0.19|||ANCOVA|||Change at Week 40: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariates, and study site as a random effect.||0.19|-0.35|0.5756
72439606|NCT02528188|144393168|SUPERIORITY||LS Mean Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.14||0.4394|TWO_SIDED|95.0|-0.38|0.16|||ANCOVA|||Change at Week 48: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariates, and study site as a random effect.||0.16|-0.38|0.4394
72439607|NCT02528188|144393168|SUPERIORITY||LS Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.14||0.7747|TWO_SIDED|95.0|-0.31|0.23|||ANCOVA|||Change at Week 48: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariates, and study site as a random effect.||0.23|-0.31|0.7747
72439608|NCT02528188|144393168|SUPERIORITY||LS Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.14||0.7305|TWO_SIDED|95.0|-0.32|0.22|||ANCOVA|||Change at Week 56: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariates, and study site as a random effect.||0.22|-0.32|0.7305
72439609|NCT02528188|144393168|SUPERIORITY||LS Mean Difference|0.05|STANDARD_ERROR_OF_MEAN|0.14||0.733|TWO_SIDED|95.0|-0.22|0.32|||ANCOVA|||Change at Week 56: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariates, and study site as a random effect.||0.32|-0.22|0.7330
72439610|NCT02528188|144393170|SUPERIORITY||LS Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.03||0.2159|TWO_SIDED|95.0|-0.1|0.02|||ANCOVA|||Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline PGA and baseline diary average pain as covariates, and study site as a random effect.||0.02|-0.10|0.2159
72439611|NCT02528188|144393170|SUPERIORITY||LS Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.03||0.2049|TWO_SIDED|95.0|-0.1|0.02|||ANCOVA|||Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline PGA and baseline diary average pain as covariates, and study site as a random effect.||0.02|-0.10|0.2049
72504749|NCT03114969|144540501|SUPERIORITY||Odds Ratio (OR)|2.503||||0.108|TWO_SIDED|95.0|0.818|7.659||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator.|||7.659|0.818|0.108
72558939|NCT01243151|144647851|SUPERIORITY_OR_OTHER||LS Mean Difference|-57.03|STANDARD_ERROR_OF_MEAN|5.377|<|0.0001|TWO_SIDED|95.0|-67.83|-46.24|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-46.24|-67.83|<0.0001
72439612|NCT02528188|144393170|SUPERIORITY||LS Mean Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.03||0.0002|TWO_SIDED|95.0|-0.19|-0.06|||ANCOVA|||Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline PGA and baseline diary average pain as covariates, and study site as a random effect.||-0.06|-0.19|0.0002
72439613|NCT02528188|144393170|SUPERIORITY||LS Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.03|<|0.0001|TWO_SIDED|95.0|-0.21|-0.08|||ANCOVA|||Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline PGA and baseline diary average pain as covariates, and study site as a random effect.||-0.08|-0.21|<0.0001
72439614|NCT02528188|144393170|SUPERIORITY||LS Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.03||0.7799|TWO_SIDED|95.0|-0.08|0.06|||ANCOVA|||Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline PGA and baseline diary average pain as covariates, and study site as a random effect.||0.06|-0.08|0.7799
72439615|NCT02528188|144393170|SUPERIORITY||LS Mean Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.03||0.0061|TWO_SIDED|95.0|-0.16|-0.03|||ANCOVA|||Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline PGA and baseline diary average pain as covariates, and study site as a random effect.||-0.03|-0.16|0.0061
72439616|NCT02528188|144393170|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.05||0.9718|TWO_SIDED|95.0|-0.1|0.1|||ANCOVA|||Change at Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline PGA and baseline diary average pain as covariates, and study site as a random effect.||0.10|-0.10|0.9718
72439617|NCT02528188|144393170|SUPERIORITY||LS Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.05||0.3292|TWO_SIDED|95.0|-0.14|0.05|||ANCOVA|||Change at Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline PGA and baseline diary average pain as covariates, and study site as a random effect.||0.05|-0.14|0.3292
72439618|NCT02528188|144393170|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.05||0.983|TWO_SIDED|95.0|-0.1|0.1|||ANCOVA|||Change at Week 32: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline PGA and baseline diary average pain as covariates, and study site as a random effect.||0.10|-0.10|0.9830
72439619|NCT02528188|144393170|SUPERIORITY||LS Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.05||0.9137|TWO_SIDED|95.0|-0.09|0.11|||ANCOVA|||Change at Week 32: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline PGA and baseline diary average pain as covariates, and study site as a random effect.||0.11|-0.09|0.9137
72558940|NCT01243151|144647851|SUPERIORITY_OR_OTHER||LS Mean Difference|-49.06|STANDARD_ERROR_OF_MEAN|5.767|<|0.0001|TWO_SIDED|95.0|-60.61|-37.51|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-37.51|-60.61|<0.0001
72558941|NCT01243151|144647851|SUPERIORITY_OR_OTHER||LS Mean Difference|-51.52|STANDARD_ERROR_OF_MEAN|5.974|<|0.0001|TWO_SIDED|95.0|-63.48|-39.56|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-39.56|-63.48|<0.0001
72495673|NCT04871711|144520657|SUPERIORITY||Risk Difference (RD)|23.9|||<|0.001|TWO_SIDED|95.0|15.2|32.7||Evaluated at 4% significance level (two-sided) using hierarchical tests, alpha splitting and alpha recycling controlling overall type 1 error at 5% (two-sided).|Cochran-Mantel-Haenszel|Stratified by region and baseline IGA-CHE score.|Mantel-Haenszel risk difference, stratified by region and baseline IGA-CHE score.|Based on the primary analysis of the primary estimand 'composite'. Subjects with missing data, subjects who received rescue treatment, or subjects who permanently discontinued IMP were considered non-responders.||32.7|15.2|<0.001
72558942|NCT01243151|144647851|SUPERIORITY_OR_OTHER||LS Mean Difference|-64.22|STANDARD_ERROR_OF_MEAN|5.901|<|0.0001|TWO_SIDED|95.0|-76.04|-52.4|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-52.40|-76.04|<0.0001
72558943|NCT01243151|144647851|SUPERIORITY_OR_OTHER||LS Mean Difference|-60.01|STANDARD_ERROR_OF_MEAN|5.785|<|0.0001|TWO_SIDED|95.0|-71.59|-48.42|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-48.42|-71.59|<0.0001
72558944|NCT01243151|144647852|SUPERIORITY_OR_OTHER||LS Mean Difference|-54.91|STANDARD_ERROR_OF_MEAN|10.392|<|0.0001|TWO_SIDED|95.0|-75.54|-34.29|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-34.29|-75.54|<0.0001
72495674|NCT04871711|144520658|SUPERIORITY||Risk Difference (RD)|19.6|||<|0.001|TWO_SIDED|95.0|11.8|27.5||Evaluated at 4% significance level (two-sided) using hierarchical tests, alpha splitting and alpha recycling controlling overall type 1 error at 5% (two-sided).|Cochran-Mantel-Haenszel|Stratified by region and baseline IGA-CHE score.|Mantel-Haenszel risk difference, stratified by region and baseline IGA-CHE score.|Based on the primary analysis of the primary estimand 'composite'. Subjects with missing data, subjects who received rescue treatment, or subjects who permanently discontinued IMP were considered non-responders.||27.5|11.8|<0.001
72495675|NCT04871711|144520659|SUPERIORITY||Risk Difference (RD)|17.2|||<|0.001|TWO_SIDED|95.0|10.1|24.3||Evaluated at 1% significance level (two-sided) using hierarchical tests, alpha splitting and alpha recycling controlling overall type 1 error at 5% (two-sided).|Cochran-Mantel-Haenszel|Stratified by region and baseline IGA-CHE score.|Mantel-Haenszel risk difference, stratified by region and baseline IGA-CHE score.|Based on the primary analysis of the primary estimand 'composite'. Subjects with missing data, subjects who received rescue treatment, or subjects who permanently discontinued IMP were considered non-responders.||24.3|10.1|<0.001
72495676|NCT04871711|144520660|SUPERIORITY||Risk Difference (RD)|25.7|||<|0.001|TWO_SIDED|95.0|17.2|34.3||Evaluated at 1% significance level (two-sided) using hierarchical tests, alpha splitting and alpha recycling controlling overall type 1 error at 5% (two-sided).|Cochran-Mantel-Haenszel|Stratified by region and baseline IGA-CHE score.|Mantel-Haenszel risk difference, stratified by region and baseline IGA-CHE score.|Based on the primary analysis of the primary estimand 'composite'. Subjects with missing data, subjects who received rescue treatment, or subjects who permanently discontinued IMP were considered non-responders.||34.3|17.2|<0.001
72495677|NCT04871711|144520661|SUPERIORITY||Risk Difference (RD)|24.2|||<|0.001|TWO_SIDED|95.0|15.5|33.0||Evaluated at 1% significance level (two-sided) using hierarchical tests, alpha splitting and alpha recycling controlling overall type 1 error at 5% (two-sided).|Cochran-Mantel-Haenszel|Stratified by region and baseline IGA-CHE score.|Mantel-Haenszel risk difference, stratified by region and baseline IGA-CHE score.|Based on the primary analysis of the primary estimand 'composite'. Subjects with missing data, subjects who received rescue treatment, or subjects who permanently discontinued IMP were considered non-responders.||33.0|15.5|<0.001
72495678|NCT04871711|144520662|SUPERIORITY||Mean Difference (Net)|-35.2|||<|0.001|TWO_SIDED|95.0|-46.7|-23.8||Evaluated at 1% significance level (two-sided) using hierarchical tests, alpha splitting and alpha recycling controlling overall type 1 error at 5% (two-sided).|ANCOVA|Adjusted for treatment, region, baseline IGA-CHE score, and baseline HECSI score.||Primary analysis of primary estimand 'composite'. Missing data for subjects who did not attend the visit was imputed as WOCF (including baseline value). For subjects who received rescue treatment or subjects who have permanently discontinued the IMP, observed data was considered non-response by using WOCF (including baseline value).||-23.8|-46.7|<0.001
72495679|NCT04871711|144520663|SUPERIORITY||Mean Difference (Net)|-3.6|||<|0.001|TWO_SIDED|95.0|-4.7|-2.6||Evaluated at 1% significance level (two-sided) using hierarchical tests, alpha splitting and alpha recycling controlling overall type 1 error at 5% (two-sided).|ANCOVA|Adjusted for treatment, region, baseline IGA-CHE score, and baseline DLQI score.||Primary analysis of primary estimand 'composite'. Missing data for subjects who did not attend the visit was imputed as WOCF (including baseline value). For subjects who received rescue treatment or subjects who have permanently discontinued the IMP, observed data was considered non-response by using WOCF (including baseline value).||-2.6|-4.7|<0.001
72495680|NCT04871711|144520664|SUPERIORITY||Mean Difference (Net)|-1.7|||<|0.001|TWO_SIDED|95.0|-2.2|-1.2||Evaluated at 1% significance level (two-sided) using hierarchical tests, alpha splitting and alpha recycling controlling overall type 1 error at 5% (two-sided).|ANCOVA|Adjusted for treatment, region, baseline IGA-CHE score, and baseline HESD score.||Primary analysis of primary estimand 'composite'. Missing data for subjects who did not attend the visit was imputed as WOCF (including baseline value). For subjects who received rescue treatment or subjects who have permanently discontinued the IMP, observed data was considered non-response by using WOCF (including baseline value).||-1.2|-2.2|<0.001
72495681|NCT04871711|144520665|SUPERIORITY||Mean Difference (Net)|-1.7|||<|0.001|TWO_SIDED|95.0|-2.3|-1.2||Evaluated at 1% significance level (two-sided) using hierarchical tests, alpha splitting and alpha recycling controlling overall type 1 error at 5% (two-sided).|ANCOVA|Adjusted for treatment, region, baseline IGA-CHE score, and baseline HESD itch score.||Primary analysis of primary estimand 'composite'. Missing data for subjects who did not attend the visit was imputed as WOCF (including baseline value). For subjects who received rescue treatment or subjects who have permanently discontinued the IMP, observed data was considered non-response by using WOCF (including baseline value).||-1.2|-2.3|<0.001
72495682|NCT04871711|144520666|SUPERIORITY||Mean Difference (Net)|-1.6|||<|0.001|TWO_SIDED|95.0|-2.1|-1.0||Evaluated at 1% significance level (two-sided) using hierarchical tests, alpha splitting and alpha recycling controlling overall type 1 error at 5% (two-sided).|ANCOVA|Adjusted for treatment, region, baseline IGA-CHE score, and baseline HESD pain score.||Primary analysis of primary estimand 'composite'. Missing data for subjects who did not attend the visit was imputed as WOCF (including baseline value). For subjects who received rescue treatment or subjects who have permanently discontinued the IMP, observed data was considered non-response by using WOCF (including baseline value).||-1.0|-2.1|<0.001
72495683|NCT04871711|144520667|SUPERIORITY||Mean Difference (Net)|-0.64|||<|0.001|TWO_SIDED|95.0|-0.83|-0.45||Evaluated at 1% significance level (two-sided) using hierarchical tests, alpha splitting and alpha recycling controlling overall type 1 error at 5% (two-sided).|ANCOVA|Adjusted for treatment, region, baseline IGA-CHE score, and baseline HEIS score.||Primary analysis of primary estimand 'composite'. Missing data for subjects who did not attend the visit was imputed as WOCF (including baseline value). For subjects who received rescue treatment or subjects who have permanently discontinued the IMP, observed data was considered non-response by using WOCF (including baseline value).||-0.45|-0.83|<0.001
72495684|NCT04871711|144520668|SUPERIORITY||Mean Difference (Net)|-0.6|||<|0.001|TWO_SIDED|95.0|-0.79|-0.4||Evaluated at 1% significance level (two-sided) using hierarchical tests, alpha splitting and alpha recycling controlling overall type 1 error at 5% (two-sided).|ANCOVA|Adjusted for treatment, region, baseline IGA-CHE score, and baseline HEIS PDAL score.||Primary analysis of primary estimand 'composite'. Missing data for subjects who did not attend the visit was imputed as WOCF (including baseline value). For subjects who received rescue treatment or subjects who have permanently discontinued the IMP, observed data was considered non-response by using WOCF (including baseline value).||-0.40|-0.79|<0.001
72495685|NCT04871711|144520669|SUPERIORITY||Risk Difference (RD)|24.5|||<|0.001|TWO_SIDED|95.0|15.0|33.9||Evaluated at 1% significance level (two-sided) using hierarchical tests, alpha splitting and alpha recycling controlling overall type 1 error at 5% (two-sided).|Cochran-Mantel-Haenszel|Stratified by region and baseline IGA-CHE score.|Mantel-Haenszel risk difference, stratified by region and baseline IGA-CHE score.|Based on the primary analysis of the primary estimand 'composite'. Subjects with missing data, subjects who received rescue treatment, or subjects who permanently discontinued IMP were considered non-responders.||33.9|15.0|<0.001
72495686|NCT03979274|144520671|EQUIVALENCE|Bio-equivalence Analysis was performed with Equivalence Acceptance Range for 90% Confidence Interval (CI) as 80.00% - 125.00%.|Geometric mean ratio|98.53|||||TWO_SIDED|90.0|94.55|102.68||||||||102.68|94.55|
72495687|NCT03979274|144520672|EQUIVALENCE|Bio-equivalence Analysis was performed with Equivalence Acceptance Range for 90% Confidence Interval (CI) as 80.00% - 125.00%.|Geometric mean ratio|97.59|||||TWO_SIDED|90.0|91.34|104.26||||||||104.26|91.34|
72439620|NCT02528188|144393170|SUPERIORITY||LS Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.05||0.8784|TWO_SIDED|95.0|-0.11|0.09|||ANCOVA|||Change at Week 40: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline PGA and baseline diary average pain as covariates, and study site as a random effect.||0.09|-0.11|0.8784
72439621|NCT02528188|144393170|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.05||0.9995|TWO_SIDED|95.0|-0.1|0.1|||ANCOVA|||Change at Week 40: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline PGA and baseline diary average pain as covariates, and study site as a random effect.||0.10|-0.10|0.9995
72439622|NCT02528188|144393170|SUPERIORITY||LS Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.05||0.6648|TWO_SIDED|95.0|-0.13|0.08|||ANCOVA|||Change at Week 48: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline PGA and baseline diary average pain as covariates, and study site as a random effect.||0.08|-0.13|0.6648
72439623|NCT02528188|144393170|SUPERIORITY||LS Mean Difference|0.02|STANDARD_ERROR_OF_MEAN|0.05||0.728|TWO_SIDED|95.0|-0.09|0.12|||ANCOVA|||Change at Week 48: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline PGA and baseline diary average pain as covariates, and study site as a random effect.||0.12|-0.09|0.7280
72439624|NCT02528188|144393170|SUPERIORITY||LS Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.05||0.8856|TWO_SIDED|95.0|-0.09|0.11|||ANCOVA|||Change at Week 56: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline PGA and baseline diary average pain as covariates, and study site as a random effect.||0.11|-0.09|0.8856
72439625|NCT02528188|144393170|SUPERIORITY||LS Mean Difference|0.06|STANDARD_ERROR_OF_MEAN|0.05||0.2814|TWO_SIDED|95.0|-0.05|0.16|||ANCOVA|||Change at Week 56: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline PGA and baseline diary average pain as covariates, and study site as a random effect.||0.16|-0.05|0.2814
72495688|NCT03979274|144520675|EQUIVALENCE|Bio-equivalence Analysis was performed with Equivalence Acceptance Range for 90% Confidence Interval (CI) as 80.00% - 125.00%.|Geometric mean ratio|99.73|||||TWO_SIDED|90.0|98.45|101.03||||||||101.03|98.45|
72495689|NCT03979274|144520676|EQUIVALENCE|Bio-equivalence Analysis was performed with Equivalence Acceptance Range for 90% Confidence Interval (CI) as 80.00% - 125.00%.|Geometric mean ratio|99.26|||||TWO_SIDED|90.0|97.7|100.85||||||||100.85|97.70|
72558945|NCT01243151|144647852|SUPERIORITY_OR_OTHER||LS Mean Difference|-44.07|STANDARD_ERROR_OF_MEAN|10.646|<|0.0001|TWO_SIDED|95.0|-65.21|-22.94|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-22.94|-65.21|<0.0001
72558946|NCT01243151|144647852|SUPERIORITY_OR_OTHER||LS Mean Difference|-67.98|STANDARD_ERROR_OF_MEAN|10.547|<|0.0001|TWO_SIDED|95.0|-88.92|-47.05|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-47.05|-88.92|<0.0001
72439626|NCT02528188|144393172|SUPERIORITY||Odds Ratio (OR)|1.07||||0.4691|TWO_SIDED|95.0|0.89|1.28|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 2||1.28|0.89|0.4691
72439627|NCT02528188|144393172|SUPERIORITY||Odds Ratio (OR)|0.95||||0.5451|TWO_SIDED|95.0|0.79|1.13|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 2||1.13|0.79|0.5451
72495690|NCT00535925|144520682|OTHER||Cox Proportional Hazard|0.48|||<|0.05|TWO_SIDED||||||Regression, Cox|Cox Shared Frailty Model, adjusted for age, sex, SBP, Hb, eGFR, albuminuria, HbA1c, total cholesterol, triglycerides (log-scaled) to reduce bias risk.||||||<0.05
72495691|NCT03551743|144520738|SUPERIORITY||Least Squares Means (Difference)|-65.02||||0.0344|TWO_SIDED||||||ANCOVA|||||||0.0344
72495692|NCT03551743|144520738|SUPERIORITY||Least Squares Means (Difference)|-92.38||||0.0014|TWO_SIDED||||||ANCOVA|||||||0.0014
72495693|NCT03551743|144520738|SUPERIORITY||Least Squares Means (Difference)|-46.26||||0.0002|TWO_SIDED||||||ANCOVA|||||||0.0002
72495694|NCT03551743|144520739|SUPERIORITY||Least Squares Means (Difference)|88722.37||||0.0032|TWO_SIDED||||||ANCOVA|||||||0.0032
72495695|NCT03551743|144520739|SUPERIORITY||Least Squares Means (Difference)|151500.3||||0.0003|TWO_SIDED||||||ANCOVA|||||||0.0003
72439628|NCT02528188|144393172|SUPERIORITY||Odds Ratio (OR)|1.29||||0.0059|TWO_SIDED|95.0|1.08|1.54|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 4||1.54|1.08|0.0059
72439629|NCT02528188|144393172|SUPERIORITY||Odds Ratio (OR)|1.29||||0.0057|TWO_SIDED|95.0|1.08|1.55|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 4||1.55|1.08|0.0057
72439630|NCT02528188|144393172|SUPERIORITY||Odds Ratio (OR)|1.14||||0.1584|TWO_SIDED|95.0|0.95|1.38|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 8||1.38|0.95|0.1584
72439631|NCT02528188|144393172|SUPERIORITY||Odds Ratio (OR)|1.3||||0.006||95.0|1.08|1.58|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 8||1.58|1.08|0.0060
72439632|NCT02528188|144393172|SUPERIORITY||Odds Ratio (OR)|1.18||||0.1117|TWO_SIDED|95.0|0.96|1.46|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 16||1.46|0.96|0.1117
72439633|NCT02528188|144393172|SUPERIORITY||Odds Ratio (OR)|1.19||||0.1004|TWO_SIDED|95.0|0.97|1.47|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 16||1.47|0.97|0.1004
72439634|NCT02528188|144393172|SUPERIORITY||Odds Ratio (OR)|1.05||||0.6258|TWO_SIDED|95.0|0.87|1.25|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 24||1.25|0.87|0.6258
72439635|NCT02528188|144393172|SUPERIORITY||Odds Ratio (OR)|1.16||||0.1154|TWO_SIDED|95.0|0.96|1.39|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 24||1.39|0.96|0.1154
72439636|NCT02528188|144393172|SUPERIORITY||Odds Ratio (OR)|1.02||||0.8018|TWO_SIDED|95.0|0.86|1.22|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 32||1.22|0.86|0.8018
72439637|NCT02528188|144393172|SUPERIORITY||Odds Ratio (OR)|1.05||||0.5697|TWO_SIDED|95.0|0.88|1.26|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 32||1.26|0.88|0.5697
72439638|NCT02528188|144393172|SUPERIORITY||Odds Ratio (OR)|1.01||||0.9557|TWO_SIDED|95.0|0.84|1.2|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 40||1.20|0.84|0.9557
72439639|NCT02528188|144393172|SUPERIORITY||Odds Ratio (OR)|1.02||||0.8553|TWO_SIDED|95.0|0.85|1.22|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 40||1.22|0.85|0.8553
72439640|NCT02528188|144393172|SUPERIORITY||Odds Ratio (OR)|1.0||||0.9901|TWO_SIDED|95.0|0.84|1.2|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 48||1.20|0.84|0.9901
72439641|NCT02528188|144393172|SUPERIORITY||Odds Ratio (OR)|0.95||||0.587|TWO_SIDED|95.0|0.8|1.14|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 48||1.14|0.80|0.5870
72439642|NCT02528188|144393172|SUPERIORITY||Odds Ratio (OR)|1.02||||0.8302|TWO_SIDED|95.0|0.85|1.22|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 56||1.22|0.85|0.8302
72439643|NCT02528188|144393172|SUPERIORITY||Odds Ratio (OR)|0.94||||0.4823|TWO_SIDED|95.0|0.79|1.12|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 56||1.12|0.79|0.4823
72439644|NCT02528188|144393173|SUPERIORITY||Odds Ratio (OR)|1.11||||0.2938|TWO_SIDED|95.0|0.92|1.33|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 2: \>=30% reduction||1.33|0.92|0.2938
72439645|NCT02528188|144393173|SUPERIORITY||Odds Ratio (OR)|0.91||||0.3146|TWO_SIDED|95.0|0.75|1.1|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 2: \>=30% reduction||1.10|0.75|0.3146
72495696|NCT03551743|144520739|SUPERIORITY||Least Squares Means (Difference)|198560.4||||0.0004|TWO_SIDED||||||ANCOVA|||||||0.0004
72386977|NCT05147428|144282049|SUPERIORITY|||||||0.47|||||||Chi-squared|||Secondary outcomes were analyzed only for those patients who were not censored due to health plan disenrollment or death over the 6-month study observation period (n = 10 424). For analyses of secondary outcomes, we compared the 3 arms using chi-square testing for dichotomous outcomes.||||0.47
72386978|NCT05147428|144282050|SUPERIORITY|||||||0.66|||||||Log Rank|||||||0.66
72386979|NCT05147428|144282052|SUPERIORITY|||||||0.19|||||||Chi-squared|||Secondary outcomes were analyzed only for those patients who were not censored due to health plan disenrollment or death over the 6-month study observation period (n = 10 424). For analyses of secondary outcomes, we compared the 3 arms using chi-square testing for dichotomous outcomes.||||0.19
72386980|NCT05147428|144282053|SUPERIORITY|||||||0.46|||||||Chi-squared|||Secondary outcomes were analyzed only for those patients who were not censored due to health plan disenrollment or death over the 6-month study observation period (n = 10 424). For analyses of secondary outcomes, we compared the 3 arms using chi-square testing for dichotomous outcomes.||||0.46
72386981|NCT05147428|144282054|SUPERIORITY|||||||0.79|||||||Chi-squared|||Secondary outcomes were analyzed only for those patients who were not censored due to health plan disenrollment or death over the 6-month study observation period (n = 10 424). For analyses of secondary outcomes, we compared the 3 arms using chi-square testing for dichotomous outcomes.||||0.79
72386982|NCT00418015|144282058|SUPERIORITY_OR_OTHER|||||||0.54||95.0|||||Log Rank|||Log rank test||||0.54
72386983|NCT00418015|144282059|SUPERIORITY_OR_OTHER|||||||0.15||95.0|||||Log Rank|||||||0.15
72386984|NCT00418015|144282060|SUPERIORITY_OR_OTHER|||||||0.06||95.0|||||Chi-squared, Corrected|||||||0.06
72439646|NCT02528188|144393173|SUPERIORITY||Odds Ratio (OR)|1.24||||0.0748|TWO_SIDED|95.0|0.98|1.58|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 2: \>=50% reduction||1.58|0.98|0.0748
72439647|NCT02528188|144393173|SUPERIORITY||Odds Ratio (OR)|1.14||||0.3|TWO_SIDED|95.0|0.89|1.45|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 2: \>=50% reduction||1.45|0.89|0.3000
72495697|NCT03551743|144520740|SUPERIORITY||Least Squares Means (Difference)|-76.05||||0.1874|TWO_SIDED||||||ANCOVA|||||||0.1874
72386985|NCT00418015|144282061|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||Chi-squared, Corrected|||||||0.02
72386986|NCT00418015|144282062|SUPERIORITY_OR_OTHER|||||||0.23||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.23
72386987|NCT00418015|144282062|SUPERIORITY_OR_OTHER|||||||0.84||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.84
72386988|NCT01392443|144282115|OTHER|||||||0.0007|||||||single-sample biniminal test|||||||0.0007
72386989|NCT01977794|144282120|SUPERIORITY_OR_OTHER||||||<|0.001||||||P value in both groups (Amlodipine failed and Bisoprolol failed) for comparison of SBP after 18 weeks versus baseline|Paired t test|||For each group (Amlodipine failed and Bisoprolol failed) SBP after 18 weeks compared to baseline (under monotherapy). Superiority was assessed between FDC and monotherapies.||||<0.001
72386990|NCT01895062|144282125|SUPERIORITY_OR_OTHER||||||<|0.022|TWO_SIDED|95.0|||||t-test, 2 sided|||||||<0.022
72386991|NCT03019575|144282133|OTHER|Linear Mixed Model|Geometric Mean Ratio|9.43|||||TWO_SIDED|95.0|7.44|11.97||||||||11.97|7.44|
72386992|NCT00533897|144282150|SUPERIORITY_OR_OTHER||estimate of difference|9.59||||0.119|TWO_SIDED|95.0|0.83|18.34||There was no adjustment made for multiple comparisons.|Chi-squared, Corrected|||A continuity corrected Chi-square test was used to compare percentage of positive antibody responses of SC placebo vs. SC abatacept (Period II treatment groups) on Day 169. P-value was evaluated at 0.05 significance level (2-sided). 95% confidence interval (CI) for difference (SC PLA - SC ABA) between ABA and PLA in the immunogenicity rates was also calculated. Point estimates of the immunogenicity rates within the two Period II treatment group and the corresponding 95% CIs were also provided.||18.34|0.83|0.119
72386993|NCT00533897|144282151|SUPERIORITY_OR_OTHER||Estimate of Difference|4.88|||||TWO_SIDED|95.0|-4.5|14.25||||||Immunogenicity rates of the Period II treatment groups on Day 253 were analyzed similarly as on Day 169. However, no statistical test was carried out and no p-value was provided. Provided were: point estimates of the immunogenicity rates within the Period II treatment groups and corresponding 95% CIs, and point estimate for the difference in immunogenicity rates between these groups and corresponding 95% CI. There was no adjustment made for multiple comparisons.||14.25|-4.50|
72386994|NCT00533897|144282155|SUPERIORITY_OR_OTHER||Estimate of Difference|0.11|||||TWO_SIDED|95.0|-8.21|8.43||||||Immunogenicity rates of the Period II treatment groups on Day 253 were analyzed similarly as on Day 169. However, no statistical test was carried out and no p-value was provided. Provided were: point estimates of the immunogenicity rates within the Period II treatment groups and corresponding 95% CIs, and point estimate for the difference in immunogenicity rates between these groups and corresponding 95% CI. There was no adjustment made for multiple comparisons.||8.43|-8.21|
72386995|NCT03228433|144282223|EQUIVALENCE|A linear mixed effect model on the natural log-transformed parameters was performed with a fixed effect for regimen and random effect for participant. The least squares(LS) means and difference of least squares (LS) means for the log-transformed parameters were exponentiated to obtain the point estimates (Geometric LS means) of the food effect and 90% confidence intervals (CIs).|Least Squares (LS) Mean Difference|0.951|||||TWO_SIDED|90.0|0.823|1.099||||||||1.099|0.823|
72386996|NCT03228433|144282223|EQUIVALENCE|A linear regression model (power model), log (ln) (parameter) equal to (=) intercept plus (+) slope\*ln (dose), was fit to describe the relationship between each parameter and the corresponding dose levels. Dose Proportionality was declared if the 90% CI of the slope lied entirely within the critical region as defined by 1 - ln(0.8) per (/)l n(r) to 1 + ln(1.25)/ln(r), where r was the ratio of the highest and lowest dose in the study.|Slope|1.14|||||TWO_SIDED|90.0|1.04|1.25||||||||1.25|1.04|
72386997|NCT03228433|144282224|EQUIVALENCE|Bioequivalence interval of 627.51 to 659.59|LS Mean Difference|0.951|||||TWO_SIDED|90.0|0.825|1.097||||||||1.097|0.825|
72386998|NCT03228433|144282224|EQUIVALENCE|A linear regression model (power model), ln (parameter) = intercept + slope\*ln (dose), was fit to describe the relationship between each parameter and the corresponding dose levels. Dose Proportionality was declared if the 90% CI of the slope lied entirely within the critical region as defined by 1 - ln (0.8)/l n(r) to 1 + ln (1.25)/ln(r), where r was the ratio of the highest and lowest dose in the study.|Slope|1.11|||||TWO_SIDED|90.0|1.0|1.22||||||||1.22|1.00|
72386999|NCT03228433|144282225|EQUIVALENCE|A linear mixed effect model on the natural log-transformed parameters was performed with a fixed effect for regimen and random effect for participant. The LS means and difference of LS means for the log-transformed parameters were exponentiated to obtain the point estimates (Geometric LS means) of the food effect and 90% confidence intervals CIs.|LS Mean Difference|0.58|||||TWO_SIDED|90.0|0.431|0.781||||||||0.781|0.431|
72387000|NCT03228433|144282225|EQUIVALENCE|A linear regression model (power model), ln (parameter) = intercept + slope\*ln (dose), was fit to describe the relationship between each parameter and the corresponding dose levels. Dose Proportionality was declared if the 90% CI of the slope lied entirely within the critical region as defined by 1 - ln (0.8)/l n(r) to 1 + ln (1.25)/ln(r), where r was the ratio of the highest and lowest dose in the study.|Slope|1.06||||||90.0|0.96|1.17||||||||1.17|0.96|
72387001|NCT04424888|144282261|SUPERIORITY|||||||0.21875|||||||Wilcoxon (Mann-Whitney)|||||||0.21875
72387002|NCT04424888|144282262|SUPERIORITY|||||||0.90625|||||||Wilcoxon (Mann-Whitney)|||||||0.90625
72387003|NCT04424888|144282263|SUPERIORITY|||||||0.02|||||||t-test, 1 sided|||Paired t-test for the species Akkermansia Munciphilae.||||0.020
72387004|NCT04424888|144282263|SUPERIORITY|||||||0.078|||||||t-test, 1 sided|||Paired t-test for the species Bifidobacterium infantis.||||0.078
72387005|NCT04424888|144282263|SUPERIORITY|||||||||||||||||Paired t-test for the species Clostridium beijerinckii.|No statistical test was conducted since Clostridium beijerinckii was not detected in any sample.|||
72387006|NCT04424888|144282263|SUPERIORITY|||||||0.2|||||||t-test, 1 sided|||Paired t-test for the species Clostridium butyricum.||||0.20
72387007|NCT04424888|144282263|SUPERIORITY|||||||0.12|||||||t-test, 1 sided|||Paired t-test for the species Anaerobutyricum hallii.||||0.12
72387008|NCT04424888|144282264|OTHER||||||||||||||||||All participants had the same number of sensors (3) throughout the study, so no statistical analysis is conducted.|||
72387009|NCT04424888|144282265|SUPERIORITY|||||||0.41|||||||t-test, 1 sided|||We test whether the average number of daily photos is greater in period 1 than in period 2.||||0.41
72387010|NCT04424888|144282266|SUPERIORITY|||||||0.13|||||||t-test, 1 sided|||We test whether the average time between consecutive scans is smaller in period 1 than in period 2.||||0.13
72387011|NCT02390908|144282275|SUPERIORITY||Beta|0.22||||0.39|TWO_SIDED|95.0|-0.28|0.72||A latent growth curve (LGC) with an intercept and linear slope was specified. The intercept quoted here represents the difference between Site 1 and the No-Treatment Group at the 3-month follow-up.|Latent Growth Curve|Analysis adjusted for gender and pre-baseline value of the outcome.|The main effect of receiving the PLUS intervention at Site 1 on log-transformed Viral Load was estimated against the No-Treatment Control EMR Group.|||0.72|-0.28|0.39
72387012|NCT02390908|144282275|SUPERIORITY||Beta|-0.03||||0.94|TWO_SIDED|95.0|-0.84|0.79||A latent growth curve (LGC) with an intercept and linear slope was specified. The intercept quoted here represents the difference between Site 2 and the No-Treatment Group at the 3-month follow-up.|Latent Growth Curve|Analysis adjusted for gender and pre-baseline value of the outcome.|The main effect of receiving the PLUS intervention at Site 2 on log-transformed Viral Load was estimated against the No-Treatment Control EMR Group.|||0.79|-0.84|0.94
72495698|NCT03551743|144520740|SUPERIORITY||Least Squares Means (Difference)|-27.98||||0.386|TWO_SIDED||||||ANCOVA|||||||0.386
72387013|NCT02390908|144282275|SUPERIORITY||Beta|0.02||||0.95|TWO_SIDED|95.0|-0.69|0.74||A latent growth curve (LGC) with an intercept and linear slope was specified. The intercept quoted here represents the difference between Site 3's Immediate Delivery Group and the No-Treatment Group at the 3-month follow-up.|Latent Growth Curve|Analysis adjusted for gender and pre-baseline value of the outcome.|The main effect of receiving the PLUS intervention at Site 3 on log-transformed Viral Load was estimated against the No-Treatment Control EMR Group.|||0.74|-0.69|0.95
72387014|NCT02390908|144282275|SUPERIORITY||Beta|-0.32||||0.09|TWO_SIDED|95.0|-0.69|0.05||A latent growth curve (LGC) with an intercept and linear slope was specified. The intercept quoted here represents the difference between Site 3 (the Waitlist condition) and the No-Treatment Group at the 3-month follow-up.|Latent Growth Curve|Analysis adjusted for gender and pre-baseline value of the outcome.|The main effect of being in the Waitlist condition (i.e., not receiving the PLUS intervention at Site 3) on log-transformed Viral Load was estimated against the No-Treatment Control EMR Group.|||0.05|-0.69|0.09
72387015|NCT02390908|144282275|SUPERIORITY||Slope|-0.03||||0.79|TWO_SIDED|95.0|-0.24|0.18||Piecemeal latent growth curves (LGC) were specified with intercepts and linear slopes. Slope 1 estimated here represents linear change in log VL across the 3-,6-,9- and 12-month follow-ups for Site 1 relative to the No-Treatment EMR Control Group.|Latent Growth Curve|Analysis adjusted for gender and pre-baseline value of the outcome.||||0.18|-0.24|0.79
72387016|NCT02390908|144282275|SUPERIORITY||Slope|-0.12||||0.57|TWO_SIDED|95.0|-0.53|0.36||Piecemeal latent growth curves (LGC) were specified with intercepts and linear slopes. Slope 1 estimated here represents linear change in log VL across the 3-,6-,9- and 12-month follow-ups for Site 2 relative to the No-Treatment EMR Control Group.|Latent Growth Curve|Analysis adjusted for gender and pre-baseline value of the outcome.||||0.36|-0.53|0.57
72387017|NCT02390908|144282275|SUPERIORITY||Slope|0.01||||0.97|TWO_SIDED|95.0|-0.35|0.36||Piecemeal latent growth curves (LGC) were specified with intercepts and linear slopes. Slope 1 here represents linear change in log VL across the 3-,6-,9- and 12-month follow-ups for Site 3 (Immediate) relative to the No-Treatment EMR Control.|Latent Growth Curve|Analysis adjusted for gender and pre-baseline value of the outcome.||||0.36|-0.35|0.97
72387018|NCT02390908|144282275|SUPERIORITY||Slope|0.07||||0.41|TWO_SIDED|95.0|-0.1|0.24||Piecemeal latent growth curves (LGC) were specified with intercepts and linear slopes. Slope 1 estimated here represents linear change in log VL across the 3-,6-,9- and 12-month follow-ups for Waitlist relative to the No-Treatment EMR Control Group.|Latent Growth Curve|Analysis adjusted for gender and pre-baseline value of the outcome.||||0.24|-0.10|0.41
72387019|NCT02390908|144282275|SUPERIORITY||Slope|0.06||||0.82|TWO_SIDED|95.0|-0.41|0.52||Piecemeal latent growth curves (LGC) were specified with intercepts and linear slopes. Slope 2 estimated here represents linear change in log VL across the 12-,15-, and 18-month follow-ups for Site 1 relative to the No-Treatment EMR Control Group.|Latent Growth Curve|Analysis adjusted for gender and pre-baseline value of the outcome.||||0.52|-0.41|0.82
72387020|NCT02390908|144282275|SUPERIORITY||Slope|0.14||||0.49|TWO_SIDED|95.0|-0.26|0.53||Piecemeal latent growth curves (LGC) were specified with intercepts and linear slopes. Slope 2 estimated here represents linear change in log VL across the 12-,15-, and 18-month follow-ups for Site 2 relative to the No-Treatment EMR Control Group.|Latent Growth Curve|Analysis adjusted for gender and pre-baseline value of the outcome.||||0.53|-0.26|0.49
72387021|NCT02390908|144282275|SUPERIORITY||Slope|-0.33||||0.18|TWO_SIDED|95.0|-0.8|0.15||Piecemeal latent growth curves (LGC) were specified with intercepts and linear slopes. Slope 2 estimated here represents linear change in log VL across the 12-,15-, and 18-month follow-ups for Site 3 relative to the No-Treatment EMR Control Group.|Latent Growth Curve|Analysis adjusted for gender and pre-baseline value of the outcome.||||0.15|-0.80|0.18
72387022|NCT02390908|144282275|SUPERIORITY||Slope|0.02||||0.89|TWO_SIDED|95.0|-0.28|0.32||Piecemeal latent growth curves (LGC) were specified with intercepts and linear slopes. Slope 2 estimated here represents linear change in log VL across the 12-,15-, and 18-month follow-ups for Waitlist relative to the No-Treatment EMR Control Group.|Latent Growth Curve|Analysis adjusted for gender and pre-baseline value of the outcome.||||0.32|-0.28|0.89
72387023|NCT02390908|144282276|SUPERIORITY||Beta|1.92||||0.95|TWO_SIDED|95.0|-54.68|58.53||A latent growth curve (LGC) with an intercept and linear slope was specified. The intercept quoted here represents the difference between Site 1 and the No-Treatment Group at the 3-month follow-up.|Latent Growth Curve|Analysis adjusted for gender and pre-baseline value of the outcome.|The main effect of receiving the PLUS intervention at Site 1 on CD4 Count was estimated against the No-Treatment Control EMR Group.|||58.53|-54.68|0.95
72387024|NCT02390908|144282276|SUPERIORITY||Beta|23.99||||0.61|TWO_SIDED|95.0|-67.54|115.51||A latent growth curve (LGC) with an intercept and linear slope was specified. The intercept quoted here represents the difference between Site 2 and the No-Treatment Group at the 3-month follow-up.|Latent Growth Curve|Analysis adjusted for gender and pre-baseline value of the outcome.|The main effect of receiving the PLUS intervention at Site 2 on CD4 Count was estimated against the No-Treatment Control EMR Group.|||115.51|-67.54|0.61
72387025|NCT02390908|144282276|SUPERIORITY||Beta|-23.71||||0.48|TWO_SIDED|95.0|-88.82|41.4||A latent growth curve (LGC) with an intercept and linear slope was specified. The intercept quoted here represents the difference between Site 3's Immediate Delivery Group and the No-Treatment Group at the 3-month follow-up.|Latent Growth Curve|Analysis adjusted for gender and pre-baseline value of the outcome.|The main effect of receiving the PLUS intervention at Site 3 on CD4 Count was estimated against the No-Treatment Control EMR Group.|||41.40|-88.82|0.48
72387026|NCT02390908|144282276|SUPERIORITY||Beta|4.19||||0.88|TWO_SIDED|95.0|-49.76|58.14||A latent growth curve (LGC) with an intercept and linear slope was specified. The intercept quoted here represents the difference between Site 3 (the Waitlist condition) and the No-Treatment Group at the 3-month follow-up.|Latent Growth Curve|Analysis adjusted for gender and pre-baseline value of the outcome.|The main effect of being in the Waitlist condition (i.e., not receiving the PLUS intervention at Site 3) on log-transformed Viral Load was estimated against the No-Treatment Control EMR Group.|||58.14|-49.76|0.88
72387027|NCT02390908|144282276|SUPERIORITY||Slope|7.67||||0.59|TWO_SIDED|95.0|-19.88|35.21||Piecemeal latent growth curves (LGC) were specified with intercepts and linear slopes. Slope 1 estimated here represents linear change in CD4 count across the 3-,6-,9- and 12-month follow-ups for Site 1 relative to the No-Treatment EMR Control Group.|Latent Growth Curve|Analysis adjusted for gender and pre-baseline value of the outcome.||||35.21|-19.88|0.59
72387028|NCT02390908|144282276|SUPERIORITY||Slope|-24.95||||0.24|TWO_SIDED|95.0|-66.78|16.88||Piecemeal latent growth curves (LGC) were specified with intercepts and linear slopes. Slope 1 estimated here represents linear change in CD4 count across the 3-,6-,9- and 12-month follow-ups for Site 2 relative to the No-Treatment EMR Control Group.|Latent Growth Curve|Analysis adjusted for gender and pre-baseline value of the outcome.||||16.88|-66.78|0.24
72387029|NCT02390908|144282276|SUPERIORITY||Slope|18.32||||0.15|TWO_SIDED|95.0|-6.63|43.27||Piecemeal latent growth curves (LGC) were specified with intercepts and linear slopes. Slope 1 estimated here represents linear change in CD4 count across the 3-,6-,9- and 12-month follow-ups for Site 3 relative to the No-Treatment EMR Control Group.|Latent Growth Curve|Analysis adjusted for gender and pre-baseline value of the outcome.||||43.27|-6.63|0.15
72387030|NCT02390908|144282276|SUPERIORITY||Slope|10.27||||0.33|TWO_SIDED|95.0|-10.2|30.74||Piecemeal latent growth curves (LGC) were specified with intercepts and linear slopes. Slope 1 estimated here represents linear change in CD4 count across the 3-,6-,9- and 12-month follow-ups for Waitlist relative to No-Treatment EMR Control Group.|Latent Growth Curve|Analysis adjusted for gender and pre-baseline value of the outcome.||||30.74|-10.20|0.33
72387031|NCT02390908|144282276|SUPERIORITY||Slope|6.42||||0.8|TWO_SIDED|95.0|-44.24|57.09||Piecemeal latent growth curves (LGC) were specified with intercepts and linear slopes. Slope 2 estimated here represents linear change in CD4 count across the 12-,15-, and 18-month follow-ups for Site 1 relative to the No-Treatment EMR Control Group.|Latent Growth Curve|Analysis adjusted for gender and pre-baseline value of the outcome.||||57.09|-44.24|0.80
72387032|NCT02390908|144282276|SUPERIORITY||Slope|-5.43||||0.89|TWO_SIDED|95.0|-85.47|74.61||Piecemeal latent growth curves (LGC) were specified with intercepts and linear slopes. Slope 2 estimated here represents linear change in CD4 count across the 12-,15-, and 18-month follow-ups for Site 2 relative to the No-Treatment EMR Control Group.|Latent Growth Curve|Analysis adjusted for gender and pre-baseline value of the outcome.||||74.61|-85.47|0.89
72387033|NCT02390908|144282276|SUPERIORITY||Slope|1.16||||0.97|TWO_SIDED|95.0|-60.61|62.94||Piecemeal latent growth curves (LGC) were specified with intercepts and linear slopes. Slope 2 estimated here represents linear change in log VL across the 12-,15-, and 18-month follow-ups for Site 3 relative to the No-Treatment EMR Control Group.|Latent Growth Curve|Analysis adjusted for gender and pre-baseline value of the outcome.||||62.94|-60.61|0.97
72387034|NCT02390908|144282276|SUPERIORITY||Slope|-38.4||||0.07|TWO_SIDED|95.0|-79.51|2.72||Piecemeal latent growth curves (LGC) were specified with intercepts and linear slopes. Slope 2 estimated here represents linear change in log VL across the 12-,15-, and 18-month follow-ups for Waitlist relative to the No-Treatment EMR Control Group.|Latent Growth Curve|Analysis adjusted for gender and pre-baseline value of the outcome.||||2.72|-79.51|0.07
72495699|NCT03551743|144520740|SUPERIORITY||Least Squares Means (Difference)|-49.99|||<|0.0001|TWO_SIDED||||||ANCOVA|||||||<0.0001
72439648|NCT02528188|144393173|SUPERIORITY||Odds Ratio (OR)|1.23||||0.255|TWO_SIDED|95.0|0.86|1.74|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 2: \>=70% reduction||1.74|0.86|0.2550
72439649|NCT02528188|144393173|SUPERIORITY||Odds Ratio (OR)|1.14||||0.478|TWO_SIDED|95.0|0.8|1.62|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 2: \>=70% reduction||1.62|0.80|0.4780
72439650|NCT02528188|144393173|SUPERIORITY||Odds Ratio (OR)|1.3||||0.4006|TWO_SIDED|95.0|0.7|2.42|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 2: \>=90% reduction||2.42|0.70|0.4006
72439651|NCT02528188|144393173|SUPERIORITY||Odds Ratio (OR)|1.38||||0.3089|TWO_SIDED|95.0|0.74|2.54|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 2: \>=90% reduction||2.54|0.74|0.3089
72439652|NCT02528188|144393173|SUPERIORITY||Odds Ratio (OR)|1.26||||0.0114|TWO_SIDED|95.0|1.05|1.5|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 4: \>=30% reduction||1.50|1.05|0.0114
72439653|NCT02528188|144393173|SUPERIORITY||Odds Ratio (OR)|1.23||||0.0239|TWO_SIDED|95.0|1.03|1.47|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 4: \>=30% reduction||1.47|1.03|0.0239
72439654|NCT02528188|144393173|SUPERIORITY||Odds Ratio (OR)|1.31||||0.0079|TWO_SIDED|95.0|1.07|1.6|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 4: \>=50% reduction||1.60|1.07|0.0079
72495700|NCT03434379|144520763|SUPERIORITY||Hazard Ratio (HR)|0.58||||0.0006|TWO_SIDED|95.0|0.42|0.79|||Log Rank|||At CCOD 18 months; Stratified by geographic region (Asia \[excluding Japan\] vs. rest of world), macrovascular invasion and/or extrahepatic spread (presence vs. absence), and baseline alpha-fetoprotein (AFP: \<400 vs. \>/= 400 ng/mL).||0.79|0.42|0.0006
72495701|NCT03434379|144520763|SUPERIORITY||Hazard Ratio (HR)|0.66||||0.0009|TWO_SIDED|95.0|0.52|0.85|||Log Rank|||At CCOD 30 months; Stratified by geographic region (Asia \[excluding Japan\] vs. rest of world), macrovascular invasion and/or extrahepatic spread (presence vs. absence), and baseline alpha-fetoprotein (AFP: \<400 vs. \>/= 400 ng/mL).||0.85|0.52|0.0009
72495702|NCT03434379|144520764|SUPERIORITY||Hazard Ratio (HR)|0.59|||<|0.0001|TWO_SIDED|95.0|0.47|0.76|||Log Rank|||Stratified by geographic region (Asia \[excluding Japan\] vs. rest of world), macrovascular invasion and/or extrahepatic spread (presence vs. absence), and baseline AFP (\<400 vs. \>/= 400 ng/mL).||0.76|0.47|<0.0001
72495703|NCT03434379|144520765|SUPERIORITY||Hazard Ratio (HR)|0.44||||0.0026|TWO_SIDED|95.0|0.25|0.76|||Log Rank|||At CCOD 18 months; Stratified by macrovascular invasion and/or extrahepatic spread (presence vs. absence), and baseline AFP (\<400 vs. \>/= 400 ng/mL).||0.76|0.25|0.0026
72495704|NCT03434379|144520765|SUPERIORITY||Hazard Ratio (HR)|0.53||||0.0019|TWO_SIDED|95.0|0.35|0.8|||Log Rank|||At CCOD 30 months; Stratified by macrovascular invasion and/or extrahepatic spread (presence vs. absence), and baseline AFP (\<400 vs. \>/= 400 ng/mL).||0.80|0.35|0.0019
72495705|NCT03434379|144520766|SUPERIORITY||Hazard Ratio (HR)|0.6||||0.0117|TWO_SIDED|95.0|0.4|0.9|||Log Rank|||Stratified by macrovascular invasion and/or extrahepatic spread (presence vs. absence), and baseline AFP (\<400 vs. \>/= 400 ng/mL).||0.90|0.40|0.0117
72495706|NCT03434379|144520767|SUPERIORITY||Odds Ratio (OR)|2.9|||<|0.0001|TWO_SIDED|95.0|1.68|5.01|||Cochran-Mantel-Haenszel|||Stratified by geographic region (Asia \[excluding Japan\] vs. rest of world), macrovascular invasion and/or extrahepatic spread (presence vs. absence), and baseline AFP (\<400 vs. \>/= 400 ng/mL).||5.01|1.68|<0.0001
72439655|NCT02528188|144393173|SUPERIORITY||Odds Ratio (OR)|1.32||||0.0068|TWO_SIDED|95.0|1.08|1.6|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 4: \>=50% reduction||1.60|1.08|0.0068
72439656|NCT02528188|144393173|SUPERIORITY||Odds Ratio (OR)|1.24||||0.1037|TWO_SIDED|95.0|0.96|1.62|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 4: \>=70% reduction||1.62|0.96|0.1037
72495707|NCT03434379|144520768|SUPERIORITY||Odds Ratio (OR)|3.39|||<|0.0001|TWO_SIDED|95.0|2.02|5.71|||Cochran-Mantel-Haenszel|||Stratified by geographic region (Asia \[excluding Japan\] vs. rest of world), macrovascular invasion and/or extrahepatic spread (presence vs. absence), and baseline AFP (\<400 vs. \>/= 400 ng/mL).||5.71|2.02|<0.0001
72495708|NCT03434379|144520769|SUPERIORITY||Odds Ratio (OR)|6.15|||<|0.0001|TWO_SIDED|95.0|2.99|12.66|||Cochran-Mantel-Haenszel|||Stratified by geographic region (Asia \[excluding Japan\] vs. rest of world), macrovascular invasion and/or extrahepatic spread (presence vs. absence), and baseline AFP (\<400 vs. \>/= 400 ng/mL).||12.66|2.99|<0.0001
72495709|NCT03434379|144520770|SUPERIORITY||Hazard Ratio (HR)|0.23||||0.0051|TWO_SIDED|95.0|0.08|0.7|||Log Rank|||Stratified by geographic region (Asia \[excluding Japan\] vs. rest of world), macrovascular invasion and/or extrahepatic spread (presence vs. absence), and baseline AFP (\<400 vs. \>/= 400 ng/mL).||0.70|0.08|0.0051
72558947|NCT01243151|144647852|SUPERIORITY_OR_OTHER||LS Mean Difference|-60.51|STANDARD_ERROR_OF_MEAN|10.381|<|0.0001|TWO_SIDED|95.0|-81.11|-39.9|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-39.90|-81.11|<0.0001
72495710|NCT03434379|144520771|SUPERIORITY||Hazard Ratio (HR)|0.3||||0.0048|TWO_SIDED|95.0|0.12|0.73|||Log Rank|||Stratified by geographic region (Asia \[excluding Japan\] vs. rest of world), macrovascular invasion and/or extrahepatic spread (presence vs. absence), and baseline AFP (\<400 vs. \>/= 400 ng/mL).||0.73|0.12|0.0048
72495711|NCT03434379|144520772|SUPERIORITY||Hazard Ratio (HR)|0.59||||0.4187|TWO_SIDED|95.0|0.16|2.15|||Log Rank|||Stratified by geographic region (Asia \[excluding Japan\] vs. rest of world), macrovascular invasion and/or extrahepatic spread (presence vs. absence), and baseline AFP (\<400 vs. \>/= 400 ng/mL).||2.15|0.16|0.4187
72495712|NCT03434379|144520773|SUPERIORITY||Hazard Ratio (HR)|0.59|||<|0.0001|TWO_SIDED|95.0|0.46|0.74|||Log Rank|||Stratified by geographic region (Asia \[excluding Japan\] vs. rest of world), macrovascular invasion and/or extrahepatic spread (presence vs. absence), and baseline AFP (\<400 vs. \>/= 400 ng/mL).||0.74|0.46|<.0001
72495713|NCT03434379|144520774|SUPERIORITY||Hazard Ratio (HR)|0.45|||<|0.0001|TWO_SIDED|95.0|0.36|0.57|||Log Rank|||Stratified by geographic region (Asia \[excluding Japan\] vs. rest of world), macrovascular invasion and/or extrahepatic spread (presence vs. absence), and baseline AFP (\<400 vs. \>/= 400 ng/mL).||0.57|0.36|<.0001
72495714|NCT03434379|144520775|SUPERIORITY||Hazard Ratio (HR)|0.7||||0.0105|TWO_SIDED|95.0|0.53|0.92|||Log Rank|||Stratified by geographic region (Asia \[excluding Japan\] vs. rest of world), macrovascular invasion and/or extrahepatic spread (presence vs. absence), and baseline AFP (\<400 vs. \>/= 400 ng/mL).||0.92|0.53|0.0105
72495715|NCT03434379|144520776|SUPERIORITY||Hazard Ratio (HR)|0.69||||0.0063|TWO_SIDED|95.0|0.52|0.9|||Log Rank|||Stratified by geographic region (Asia \[excluding Japan\] vs. rest of world), macrovascular invasion and/or extrahepatic spread (presence vs. absence), and baseline AFP (\<400 vs. \>/= 400 ng/mL).||0.90|0.52|0.0063
72495716|NCT03434379|144520777|SUPERIORITY||Hazard Ratio (HR)|0.44|||<|0.0001|TWO_SIDED|95.0|0.35|0.57|||Log Rank|||Stratified by geographic region (Asia \[excluding Japan\] vs. rest of world), macrovascular invasion and/or extrahepatic spread (presence vs. absence), and baseline AFP (\<400 vs. \>/= 400 ng/mL).||0.57|0.35|<.0001
72495717|NCT03434379|144520778|SUPERIORITY||Hazard Ratio (HR)|0.5||||0.0019|TWO_SIDED|95.0|0.32|0.78|||Log Rank|||AFP \<400 ng/mL and stratified by geographic region (Asia \[excluding Japan\] vs. rest of world), macrovascular invasion and/or extrahepatic spread (presence vs. absence).||0.78|0.32|0.0019
72495718|NCT03434379|144520778|SUPERIORITY||Hazard Ratio (HR)|0.67||||0.0879|TWO_SIDED|95.0|0.42|1.06|||Log Rank|||AFP \>/= 400 ng/mL and stratified by geographic region (Asia \[excluding Japan\] vs. rest of world), macrovascular invasion and/or extrahepatic spread (presence vs. absence).||1.06|0.42|0.0879
72495719|NCT03434379|144520779|SUPERIORITY||Hazard Ratio (HR)|0.5|||<|0.0001|TWO_SIDED|95.0|0.37|0.68|||Log Rank|||AFP\<400 ng/mL and stratified by geographic region (Asia \[excluding Japan\] vs. rest of world), macrovascular invasion and/or extrahepatic spread (presence vs. absence).||0.68|0.37|<.0001
72495720|NCT03434379|144520779|SUPERIORITY||Hazard Ratio (HR)|0.78||||0.2159|TWO_SIDED|95.0|0.53|1.15|||Log Rank|||AFP \>/=400 ng/mL and stratified by geographic region (Asia \[excluding Japan\] vs. rest of world), macrovascular invasion and/or extrahepatic spread (presence vs. absence).||1.15|0.53|0.2159
72558948|NCT01243151|144647852|SUPERIORITY_OR_OTHER||LS Mean Difference|-68.39|STANDARD_ERROR_OF_MEAN|10.392|<|0.0001|TWO_SIDED|95.0|-89.02|-47.76|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-47.76|-89.02|<0.0001
72495721|NCT03434379|144520780|SUPERIORITY||Hazard Ratio (HR)|0.42|||<|0.0001|TWO_SIDED|95.0|0.31|0.57|||Log Rank|||AFP \<400 ng/mL and stratified by geographic region (Asia \[excluding Japan\] vs. rest of world), macrovascular invasion and/or extrahepatic spread (presence vs. absence).||0.57|0.31|<0.0001
72558949|NCT01243151|144647852|SUPERIORITY_OR_OTHER||LS Mean Difference|-60.41|STANDARD_ERROR_OF_MEAN|10.646|<|0.0001|TWO_SIDED|95.0|-81.54|-39.27|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-39.27|-81.54|<0.0001
72495722|NCT03434379|144520780|SUPERIORITY||Hazard Ratio (HR)|0.51||||0.0002|TWO_SIDED|95.0|0.35|0.73|||Log Rank|||AFP \>/=400 ng/mL and stratified by geographic region (Asia \[excluding Japan\] vs. rest of world), macrovascular invasion and/or extrahepatic spread (presence vs. absence).||0.73|0.35|0.0002
72495723|NCT03434379|144520781|SUPERIORITY||Hazard Ratio (HR)|0.53|||<|0.0001|TWO_SIDED|95.0|0.39|0.73|||Log Rank|||Physical Functioning: Stratified by geographic region (Asia \[excluding Japan\] vs. rest of world), macrovascular invasion and/or extrahepatic spread (presence vs. absence), and baseline AFP (\<400 vs. \>/= 400 ng/mL).||0.73|0.39|<.0001
72495724|NCT03434379|144520781|SUPERIORITY||Hazard Ratio (HR)|0.62||||0.0019|TWO_SIDED|95.0|0.46|0.84|||Log Rank|||Role Functioning: Stratified by geographic region (Asia \[excluding Japan\] vs. rest of world), macrovascular invasion and/or extrahepatic spread (presence vs. absence), and baseline AFP (\<400 vs. \>/= 400 ng/mL).||0.84|0.46|0.0019
72495725|NCT03434379|144520781|SUPERIORITY||Hazard Ratio (HR)|0.63||||0.0028|TWO_SIDED|95.0|0.46|0.85|||Log Rank|||GHS/QoL: Stratified by geographic region (Asia \[excluding Japan\] vs. rest of world), macrovascular invasion and/or extrahepatic spread (presence vs. absence), and baseline AFP (\<400 vs. \>/= 400 ng/mL).||0.85|0.46|0.0028
72495726|NCT03434379|144520786|SUPERIORITY||Odds Ratio (OR)|4.6||||0.0036|TWO_SIDED|95.0|1.53|13.86|||Cochran-Mantel-Haenszel|||Stratified by macrovascular invasion and/or extrahepatic spread (presence vs. absence), and baseline AFP (\<400 vs. \>/= 400 ng/mL).||13.86|1.53|0.0036
72495727|NCT03434379|144520787|SUPERIORITY||Odds Ratio (OR)|4.71||||0.0013|TWO_SIDED|95.0|1.72|12.87|||Cochran-Mantel-Haenszel|||Stratified by macrovascular invasion and/or extrahepatic spread (presence vs. absence), and baseline AFP (\<400 vs. \>/= 400 ng/mL).||12.87|1.72|0.0013
72558950|NCT01243151|144647852|SUPERIORITY_OR_OTHER||LS Mean Difference|-86.6|STANDARD_ERROR_OF_MEAN|10.656|<|0.0001|TWO_SIDED|95.0|-107.74|-65.46|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-65.46|-107.74|<0.0001
72387035|NCT02390908|144282277|SUPERIORITY||Beta|-7.87||||0.22|TWO_SIDED|95.0|-20.52|4.78||A latent growth curve (LGC) with an intercept and linear slope was specified. The intercept quoted here represents the difference between Site 1 and the Waitlist Group at the 3-month follow-up.|Latent Growth Curve|Analysis adjusted for gender and pre-baseline value of the outcome.|The main effect of receiving the PLUS intervention at Site 1 on ART Medication Adherence was estimated against Site 3's Waitlist Control Group.|||4.78|-20.52|0.22
72439657|NCT02528188|144393173|SUPERIORITY||Odds Ratio (OR)|1.45||||0.0046|TWO_SIDED|95.0|1.12|1.88|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 4: \>=70% reduction||1.88|1.12|0.0046
72439658|NCT02528188|144393173|SUPERIORITY||Odds Ratio (OR)|1.36||||0.1971|TWO_SIDED|95.0|0.85|2.19|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 4: \>=90% reduction||2.19|0.85|0.1971
72439659|NCT02528188|144393173|SUPERIORITY||Odds Ratio (OR)|1.59||||0.048|TWO_SIDED|95.0|1.0|2.52|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 4: \>=90% reduction||2.52|1.00|0.0480
72387036|NCT02390908|144282277|SUPERIORITY||Beta|10.29||||0.22|TWO_SIDED|95.0|-6.25|26.82||A latent growth curve (LGC) with an intercept and linear slope was specified. The intercept quoted here represents the difference between Site 2 and the Waitlist Group at the 3-month follow-up.|Latent Growth Curve|Analysis adjusted for gender and pre-baseline value of the outcome.|The main effect of receiving the PLUS intervention at Site 2 on ART Medication Adherence was estimated against Site 3's Waitlist Control Group.|||26.82|-6.25|0.22
72387037|NCT02390908|144282277|SUPERIORITY||Beta|-0.27||||0.96|TWO_SIDED|95.0|-11.63|11.08||A latent growth curve (LGC) with an intercept and linear slope was specified. The intercept quoted here represents the difference between Site 3's Immediate Delivery Group and the Waitlist Group at the 3-month follow-up.|Latent Growth Curve|Analysis adjusted for gender and baseline value of the outcome.|The main effect of receiving the PLUS intervention immediately at Site 3 on ART Medication Adherence was estimated against Site 3's Waitlist Control Group.|||11.08|-11.63|0.96
72439660|NCT02528188|144393173|SUPERIORITY||Odds Ratio (OR)|1.07||||0.4744|TWO_SIDED|95.0|0.89|1.28|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 8: \>=30% reduction||1.28|0.89|0.4744
72439661|NCT02528188|144393173|SUPERIORITY||Odds Ratio (OR)|1.21||||0.0336|TWO_SIDED|95.0|1.02|1.45|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 8: \>=30% reduction||1.45|1.02|0.0336
72439662|NCT02528188|144393173|SUPERIORITY||Odds Ratio (OR)|1.2||||0.0559|TWO_SIDED|95.0|1.0|1.44|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 8: \>=50% reduction||1.44|1.00|0.0559
72439663|NCT02528188|144393173|SUPERIORITY||Odds Ratio (OR)|1.34||||0.0021|TWO_SIDED|95.0|1.11|1.61|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 8: \>=50% reduction||1.61|1.11|0.0021
72439664|NCT02528188|144393173|SUPERIORITY||Odds Ratio (OR)|1.26||||0.0535|TWO_SIDED|95.0|1.0|1.59|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 8: \>=70% reduction||1.59|1.00|0.0535
72439665|NCT02528188|144393173|SUPERIORITY||Odds Ratio (OR)|1.53||||0.0003|TWO_SIDED|95.0|1.22|1.92|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 8: \>=70% reduction||1.92|1.22|0.0003
72439666|NCT02528188|144393173|SUPERIORITY||Odds Ratio (OR)|1.11||||0.6421|TWO_SIDED|95.0|0.72|1.7|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 8: \>=90% reduction||1.70|0.72|0.6421
72439667|NCT02528188|144393173|SUPERIORITY||Odds Ratio (OR)|1.6||||0.0207|TWO_SIDED|95.0|1.07|2.38|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 8: \>=90% reduction||2.38|1.07|0.0207
72439668|NCT02528188|144393173|SUPERIORITY||Odds Ratio (OR)|1.15||||0.1635|TWO_SIDED|95.0|0.95|1.39|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 16: \>=30% reduction||1.39|0.95|0.1635
72439669|NCT02528188|144393173|SUPERIORITY||Odds Ratio (OR)|1.21||||0.0529|TWO_SIDED|95.0|1.0|1.47|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 16: \>=30% reduction||1.47|1.00|0.0529
72495728|NCT03434379|144520788|SUPERIORITY||Odds Ratio (OR)|5.05||||0.0052|TWO_SIDED|95.0|1.47|17.39|||Cochran-Mantel-Haenszel|||Stratified by macrovascular invasion and/or extrahepatic spread (presence vs. absence), and baseline AFP (\<400 vs. \>/= 400 ng/mL).||17.39|1.47|0.0052
72439670|NCT02528188|144393173|SUPERIORITY|The two key secondary comparisons for 'Participants with \>=50% reduction from baseline in WOMAC Pain at Week 16' (tanezumab 2.5 mg treatment group versus NSAID and tanezumab 5 mg treatment group versus NSAID) could not be considered significant since preceding tests in the graphical testing procedure were not significant.|Odds Ratio (OR)|1.15||||0.1322|TWO_SIDED|95.0|0.96|1.37|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 16: \>=50% reduction||1.37|0.96|0.1322
72439671|NCT02528188|144393173|SUPERIORITY|The two key secondary comparisons for 'Participants with \>=50% reduction from baseline in WOMAC Pain at Week 16' (tanezumab 2.5 mg treatment group versus NSAID and tanezumab 5 mg treatment group versus NSAID) could not be considered significant since preceding tests in the graphical testing procedure were not significant.|Odds Ratio (OR)|1.22||||0.0262|TWO_SIDED|95.0|1.02|1.46|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 16: \>=50% reduction||1.46|1.02|0.0262
72439672|NCT02528188|144393173|SUPERIORITY||Odds Ratio (OR)|1.0||||0.9805|TWO_SIDED|95.0|0.83|1.22|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 16: \>=70% reduction||1.22|0.83|0.9805
72439673|NCT02528188|144393173|SUPERIORITY||Odds Ratio (OR)|1.33||||0.0033|TWO_SIDED|95.0|1.1|1.61|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 16: \>=70% reduction||1.61|1.10|0.0033
72387038|NCT02390908|144282277|SUPERIORITY||Slope|6.34||||0.03|TWO_SIDED|95.0|0.72|11.97||A latent growth curve (LGC) with an intercept and linear slope was specified. The slope estimated here represents linear change in Medication Adherence across the 3-, 6-, 9- and 12-month follow-ups for Site 1 relative to Waitlist Control Group.|Latent Growth Curve|Analysis adjusted for gender and baseline value of the outcome.||||11.97|0.72|0.03
72387039|NCT02390908|144282277|SUPERIORITY||Slope|3.35||||0.42|TWO_SIDED|95.0|-4.78|11.47||A latent growth curve (LGC) with an intercept and linear slope was specified. The slope estimated here represents linear change in Medication Adherence across the 3-, 6-, 9- and 12-month follow-ups for Site 2 relative to Waitlist Control Group.|Latent Growth Curve|Analysis adjusted for gender and baseline value of the outcome.||||11.47|-4.78|0.42
72387040|NCT02390908|144282277|SUPERIORITY||Slope|0.34||||0.91|TWO_SIDED|95.0|-5.85|6.54||A latent growth curve (LGC) with an intercept and linear slope was specified. The slope estimated here represents linear change in Medication Adherence across 3-,6-,9- and 12-month follow-ups for Site 3 (Immediate) relative to Waitlist Control Group.|Latent Growth Curve|Analysis adjusted for gender and baseline value of the outcome.||||6.54|-5.85|0.91
72387041|NCT02390908|144282278|SUPERIORITY||Beta|3.19||||0.02|TWO_SIDED|95.0|0.61|5.78||A latent growth curve (LGC) with an intercept and linear slope was specified. The intercept quoted here represents the difference between Site 1 and the Waitlist Group at the 3-month follow-up.|Latent Growth Curve|Analysis adjusted for gender and baseline value of the outcome.|The main effect of receiving the PLUS intervention at Site 1 on Alcohol Use severity (AUDIT) was estimated against Site 3's Waitlist Control Group.|||5.78|0.61|0.02
72387042|NCT02390908|144282278|SUPERIORITY||Beta|-0.86||||0.63|TWO_SIDED|95.0|-4.33|2.61||A latent growth curve (LGC) with an intercept and linear slope was specified. The intercept quoted here represents the difference between Site 2 and the Waitlist Group at the 3-month follow-up.|Latent Growth Curve|Analysis adjusted for gender and baseline value of the outcome.|The main effect of receiving the PLUS intervention at Site 2 on Alcohol Use severity (AUDIT) was estimated against Site 3's Waitlist Control Group.|||2.61|-4.33|0.63
72387043|NCT02390908|144282278|SUPERIORITY||Beta|4.17||||0.02|TWO_SIDED|95.0|0.8|7.54||A latent growth curve (LGC) with an intercept and linear slope was specified. The intercept quoted here represents the difference between Site 3's Immediate Delivery Group and the Waitlist Group at the 3-month follow-up.|Latent Growth Curve|Analysis adjusted for gender and baseline value of the outcome.|The main effect of receiving the PLUS intervention immediately at Site 3 on Alcohol Use severity (AUDIT) was estimated against Site 3's Waitlist Control Group.|||7.54|0.80|0.02
72387044|NCT02390908|144282278|SUPERIORITY||Slope|-0.4||||0.46|TWO_SIDED|95.0|-1.47|0.67||A latent growth curve (LGC) with an intercept and linear slope was specified. The slope estimated here represents linear change in AUDIT across the 3-, 6-, 9- and 12-month follow-ups for Site 1 relative to that for the Waitlist Control Group.|Latent Growth Curve|Analysis adjusted for gender and baseline value of the outcome.||||0.67|-1.47|0.46
72387045|NCT02390908|144282278|SUPERIORITY||Slope|-0.29||||0.5|TWO_SIDED|95.0|-1.12|0.55||A latent growth curve (LGC) with an intercept and linear slope was specified. The slope estimated here represents linear change in AUDIT across the 3-, 6-, 9- and 12-month follow-ups for Site 2 relative to that for the Waitlist Control Group.|Latent Growth Curve|Analysis adjusted for gender and baseline value of the outcome.||||0.55|-1.12|0.50
72387046|NCT02390908|144282278|SUPERIORITY||Slope|-0.35||||0.43|TWO_SIDED|95.0|-1.23|0.52||A latent growth curve (LGC) with an intercept and linear slope was specified. The slope estimated here represents linear change in AUDIT across the 3-, 6-, 9- and 12-month follow-ups for Site 3 (Immediate) relative to Waitlist Control Group.|Latent Growth Curve|Analysis adjusted for gender and baseline value of the outcome.||||0.52|-1.23|0.43
72387047|NCT01781975|144282279|SUPERIORITY||ANCOVA|0.0616|STANDARD_ERROR_OF_MEAN|0.0364||0.048|TWO_SIDED|90.0|0.00176|0.121|||ANCOVA|||||0.121|0.00176|0.048
72387048|NCT05280782|144282320|EQUIVALENCE|A McNemar test was performed between baseline and post-injection Systolic Blood Pressure values. The values were categorized as Normal or Abnormal.|||||||||||||||||The McNemar test requires at least one participant for each outcome (Normal or Abnormal). Thus, no p-value was computed because all of the Systolic Blood Pressure values were normal.|||
72387049|NCT05280782|144282320|EQUIVALENCE|A McNemar test was performed between baseline and post-injection Diastolic Blood Pressure values. The values were categorized as Normal or Abnormal.|||||||||||||||||The McNemar test requires at least one participant for each outcome (Normal or Abnormal). Thus, no p-value was computed because all of the Diastolic Blood Pressure values were normal.|||
72387050|NCT05280782|144282321|EQUIVALENCE|A McNemar test was performed between baseline and post-injection Heart Rate values. The values were categorized as Normal or Abnormal.|||||||||||||||||The McNemar test requires at least one participant for each outcome (Normal or Abnormal). Thus, no p-value was computed because all of the Heart Rate values were normal.|||
72387051|NCT05280782|144282322|EQUIVALENCE|A McNemar test was performed between baseline and post-injection Respiratory Rate values. The values were categorized as Normal or Abnormal.||||||0.016||||||The threshold for statistical significance was p = 0.05.|McNemar|||||||0.016
72387052|NCT05280782|144282323|EQUIVALENCE|A McNemar test was performed between baseline and post-injection Temperature values. The values were categorized as Normal or Abnormal.|||||||||||||||||The McNemar test requires at least one participant for each outcome (Normal or Abnormal). Thus, no p-value was computed because all of the Temperature values were normal.|||
72387053|NCT05280782|144282324|EQUIVALENCE|A McNemar test was performed between baseline and post-injection EKG. The outcomes were categorized as Normal or Abnormal.|||||||||||||||||The McNemar test requires at least one participant for each outcome (Normal or Abnormal). Thus, no p-value was computed because all of the EKGs were normal.|||
72387054|NCT05280782|144282325|EQUIVALENCE|A McNemar test was performed between baseline and post-injection EKG. The outcomes were categorized as Normal or Abnormal.|||||||||||||||||The McNemar test requires at least one participant for each outcome (Normal or Abnormal). Thus, no p-value was computed because all of the EKGs were normal.|||
72387055|NCT05280782|144282326|EQUIVALENCE|A McNemar test was performed between baseline and post-injection Sodium values. The values were categorized as Normal or Abnormal.|||||||||||||||||The McNemar test requires at least one participant for each outcome (Normal or Abnormal). Thus, no p-value was computed because all of the Sodium values were normal.|||
72387056|NCT05280782|144282326|EQUIVALENCE|A McNemar test was performed between baseline and post-injection Potassium values. The values were categorized as Normal or Abnormal.|||||||||||||||||The McNemar test requires at least one participant for each outcome (Normal or Abnormal). Thus, no p-value was computed because all of the Potassium values were normal.|||
72387057|NCT05280782|144282326|EQUIVALENCE|A McNemar test was performed between baseline and post-injection Chloride values. The values were categorized as Normal or Abnormal.|||||||||||||||||The McNemar test requires at least one participant for each outcome (Normal or Abnormal). Thus, no p-value was computed because all of the Chloride values were normal.|||
72387058|NCT05280782|144282326|EQUIVALENCE|A McNemar test was performed between baseline and post-injection CO2 values. The values were categorized as Normal or Abnormal.||||||0.219||||||The threshold for statistical significance was p = 0.05.|McNemar|||||||0.219
72387059|NCT05280782|144282327|EQUIVALENCE|A McNemar test was performed between baseline and post-injection Glucose values. The values were categorized as Normal or Abnormal.||||||0.375||||||The threshold for statistical significance was p = 0.05.|McNemar|||||||0.375
72387060|NCT05280782|144282327|EQUIVALENCE|A McNemar test was performed between baseline and post-injection Calcium values. The values were categorized as Normal or Abnormal.||||||0.375||||||The threshold for statistical significance was p = 0.05.|McNemar|||||||0.375
72439674|NCT02528188|144393173|SUPERIORITY||Odds Ratio (OR)|1.24||||0.159|TWO_SIDED|95.0|0.92|1.69|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 16: \>=90% reduction||1.69|0.92|0.1590
72439675|NCT02528188|144393173|SUPERIORITY||Odds Ratio (OR)|1.57||||0.0024|TWO_SIDED|95.0|1.17|2.11|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 16: \>=90% reduction||2.11|1.17|0.0024
72387061|NCT05280782|144282327|EQUIVALENCE|A McNemar test was performed between baseline and post-injection Creatinine values. The values were categorized as Normal or Abnormal.||||||0.453||||||The threshold for statistical significance was p = 0.05.|McNemar|||||||0.453
72439676|NCT02528188|144393173|SUPERIORITY||Odds Ratio (OR)|1.0||||0.9932|TWO_SIDED|95.0|0.83|1.2|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 24: \>=30% reduction||1.20|0.83|0.9932
72439677|NCT02528188|144393173|SUPERIORITY||Odds Ratio (OR)|1.07||||0.4374|TWO_SIDED|95.0|0.9|1.29|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 24: \>=30% reduction||1.29|0.90|0.4374
72387062|NCT05280782|144282327|EQUIVALENCE|A McNemar test was performed between baseline and post-injection BUN values. The values were categorized as Normal or Abnormal.||||||0.125||||||The threshold for statistical significance was p = 0.05.|McNemar|||||||0.125
72387063|NCT05280782|144282327|EQUIVALENCE|A McNemar test was performed between baseline and post-injection Total Bilirubin values. The values were categorized as Normal or Abnormal.||||||0.219||||||The threshold for statistical significance was p = 0.05.|McNemar|||||||0.219
72387064|NCT05280782|144282328|EQUIVALENCE|A McNemar test was performed between baseline and post-injection Total Protein values. The values were categorized as Normal or Abnormal.|||||||||||||||||The McNemar test requires at least one participant for each outcome (Normal or Abnormal). Thus, no p-value was computed because all of the Total Protein values were normal.|||
72387065|NCT05280782|144282328|EQUIVALENCE|A McNemar test was performed between baseline and post-injection Albumin values. The values were categorized as Normal or Abnormal.||||||0.219||||||The threshold for statistical significance was p = 0.05.|McNemar|||||||0.219
72387066|NCT05280782|144282329|EQUIVALENCE|A McNemar test was performed between baseline and post-injection Alkaline Phosphatase values. The values were categorized as Normal or Abnormal.|||||||||||||||||The McNemar test requires at least one participant for each outcome (Normal or Abnormal). Thus, no p-value was computed because all of the Alkaline Phosphatase values were normal.|||
72387067|NCT05280782|144282329|EQUIVALENCE|A McNemar test was performed between baseline and post-injection ALT values. The values were categorized as Normal or Abnormal.||||||0.219||||||The threshold for statistical significance was p = 0.05.|McNemar|||||||0.219
72495729|NCT03434379|144520789|SUPERIORITY||Hazard Ratio (HR)|0.37||||0.4581|TWO_SIDED|95.0|0.02|5.85|||Log Rank|||Stratified by macrovascular invasion and/or extrahepatic spread (presence vs. absence), and baseline AFP (\<400 vs. \>/= 400 ng/mL).||5.85|0.02|0.4581
72387068|NCT05280782|144282329|EQUIVALENCE|A McNemar test was performed between baseline and post-injection AST values. The values were categorized as Normal or Abnormal.|||||||||||||||||The McNemar test requires at least one participant for each outcome (Normal or Abnormal). Thus, no p-value was computed because all of the AST values were normal.|||
72387069|NCT05280782|144282330|EQUIVALENCE|A McNemar test was performed between baseline and post-injection WBC values. The values were categorized as Normal or Abnormal.||||||0.687||||||The threshold for statistical significance was p = 0.05.|McNemar|||||||0.687
72387070|NCT05280782|144282331|EQUIVALENCE|A McNemar test was performed between baseline and post-injection Hemoglobin values. The values were categorized as Normal or Abnormal.||||||0.375||||||The threshold for statistical significance was p = 0.05.|McNemar|||||||0.375
72387071|NCT05280782|144282332|EQUIVALENCE|A McNemar test was performed between baseline and post-injection Hematocrit values. The values were categorized as Normal or Abnormal.||||||1||||||The threshold for statistical significance was p = 0.05.|McNemar|||||||1.000
72387072|NCT05280782|144282333|EQUIVALENCE|A McNemar test was performed between baseline and post-injection Platelets values. The values were categorized as Normal or Abnormal.|||||||||||||||||The McNemar test requires at least one participant for each outcome (Normal or Abnormal). Thus, no p-value was computed because all of the Platelets values were normal.|||
72387073|NCT05280782|144282334|EQUIVALENCE|A McNemar test was performed between baseline and post-injection RBC values. The values were categorized as Normal or Abnormal.||||||0.375||||||The threshold for statistical significance was p = 0.05.|McNemar|||||||0.375
72387074|NCT05280782|144282335|EQUIVALENCE|A McNemar test was performed between baseline and post-injection MCV values. The values were categorized as Normal or Abnormal.|||||||||||||||||The McNemar test requires at least one participant for each outcome (Normal or Abnormal). Thus, no p-value was computed because all of the MCV values were normal.|||
72387075|NCT02905149|144282337|SUPERIORITY||Median Difference (Final Values)|9.0|||<|0.05|TWO_SIDED|95.0|4.0|14.5||Not adjusted for multiple comparison|Wilcoxon (Mann-Whitney)||Generalized Hodges-Lehmann median difference is used. These are robust to the possibility that the population distributions in the two groups are different in ways other than location. It may not represent the raw median difference.|||14.5|4|< 0.05
72387076|NCT02068027|144282425|SUPERIORITY|||||||0.4503||||||MMRM imputing for missing data|Mixed Models Analysis|||||||0.4503
72387077|NCT02068027|144282426|SUPERIORITY|||||||0.735||||||MMRM imputing for missing data|Mixed Models Analysis|||||||0.7350
72387078|NCT01032174|144282428|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||The logistic regression model contained terms for treatment, gender and age.|Regression, Logistic|||||||<0.0001
72387079|NCT01032174|144282429|SUPERIORITY_OR_OTHER||Difference of Least Square Mean|1.06|STANDARD_ERROR_OF_MEAN|0.55||0.0568|TWO_SIDED|95.0|-0.03|2.15||The analysis of covariance (ANCOVA) model contained terms for treatment, gender, age and Body Mass Index (BMI).|ANCOVA|Least square mean was adjusted for gender, age and BMI.||||2.15|-0.03|0.0568
72387080|NCT01032174|144282430|SUPERIORITY_OR_OTHER|||||||0.0682|TWO_SIDED|||||The logistic regression model contained terms for treatment, gender and age.|Regression, Logistic|||||||0.0682
72387081|NCT00702689|144282434|SUPERIORITY_OR_OTHER_LEGACY|||||||0.011|||||||Paired t-test|||||||.011
72387082|NCT00702689|144282436|SUPERIORITY_OR_OTHER_LEGACY|||||||0.47|||||||t-test, 2 sided|||||||.47
72387083|NCT00702689|144282437|SUPERIORITY_OR_OTHER_LEGACY|||||||0.29|||||||t-test, 2 sided|||||||.29
72387084|NCT02761733|144282480|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.3652||||0.0679|TWO_SIDED|95.0|-6.9559|0.2255||a priori test|Mixed Models Analysis|Least Squares Mean Difference Test using LSMEANS pdiff test in SAS PROC MIXED 9.4|Satterthwaite adjusted df = 173|||.2255|-6.9559|.0679
72387085|NCT02761733|144282480|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.882||||0.0999|TWO_SIDED|95.0|-6.2957|0.5317||a priori test|Mixed Models Analysis|Least Squares Mean Difference Test using LSMEANS pdiff test in SAS PROC MIXED 9.4|Satterthwaite adjusted df = 165|||0.5317|-6.2957|.0999
72387086|NCT02761733|144282480|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.0139||||0.5588|TWO_SIDED|95.0|-4.4957|2.3779||a priori test|Mixed Models Analysis|Least Squares Mean Difference Test using LSMEANS pdiff test in SAS PROC MIXED 9.4|Satterthwaite adjusted df = 148|||2.3779|-4.4957|.5588
72387087|NCT02761733|144282480|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.2798||||0.8532|TWO_SIDED|95.0|-2.6771|3.2367||a priori test|Mixed Models Analysis|Least Squares Mean Difference Test using LSMEANS pdiff test in SAS PROC MIXED 9.4|Satterthwaite adjusted df = 136|||3.2367|-2.6771|.8532
72387088|NCT02761733|144282481|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.4524||||0.0988|TWO_SIDED|95.0|-7.5302|0.6254||a priori test|Mixed Models Analysis|Least Squares Mean Difference Test using LSMEANS pdiff test in SAS PROC MIXED 9.4|Satterthwaite adjusted df = 180|||0.6254|-7.5302|.0988
72387089|NCT02761733|144282481|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.3087||||0.876|TWO_SIDED|95.0|-4.1799|3.5625||a priori test|Mixed Models Analysis|Least Squares Mean Difference Test using LSMEANS pdiff test in SAS PROC MIXED 9.4|Satterthwaite adjusted df = 166|||3.5625|-4.1799|.8760
72387090|NCT02761733|144282481|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.541||||0.1878|TWO_SIDED|95.0|-1.2234|6.3054||a priori test|Mixed Models Analysis|Least Squares Mean Difference Test using LSMEANS pdiff test in SAS PROC MIXED 9.4|Satterthwaite adjusted df = 153|||6.3054|-1.2234|.1878
72387091|NCT02761733|144282481|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.6237||||0.333|TWO_SIDED|95.0|-4.9|1.6526||a priori test|Mixed Models Analysis|Least Squares Mean Difference Test using LSMEANS pdiff test in SAS PROC MIXED 9.4|Satterthwaite adjusted df = 143|||1.6526|-4.9000|.3330
72387092|NCT02761733|144282482|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.9284||||0.6588|TWO_SIDED|95.0|-10.4728|6.616||a priori test|Mixed Models Analysis|Least Squares Mean Difference Test using LSMEANS pdiff test in SAS PROC MIXED 9.4|Satterthwaite adjusted df = 175|||6.6160|-10.4728|.6588
72387093|NCT02761733|144282482|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.3959||||0.2633|TWO_SIDED|95.0|-2.2237|11.0155||Least Squares Mean Difference Test using LSMEANS pdiff test in SAS PROC MIXED 9.4|Mixed Models Analysis|Satterthwaite adjusted df = 169||a priori test||11.0155|-2.2237|.2633
72495730|NCT03434379|144520790|SUPERIORITY||Hazard Ratio (HR)|0.08||||0.01|TWO_SIDED|95.0|0.01|0.91|||Log Rank||Lower limit: \<0.01|Stratified by macrovascular invasion and/or extrahepatic spread (presence vs. absence), and baseline AFP (\<400 vs. \>/= 400 ng/mL).||0.91|0.01|0.0100
72558951|NCT01243151|144647852|SUPERIORITY_OR_OTHER||LS Mean Difference|-81.13|STANDARD_ERROR_OF_MEAN|10.381|<|0.0001|TWO_SIDED|95.0|-101.73|-60.52|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-60.52|-101.73|<0.0001
72558952|NCT01243151|144647852|SUPERIORITY_OR_OTHER||LS Mean Difference|-80.16|STANDARD_ERROR_OF_MEAN|10.479|<|0.0001|TWO_SIDED|95.0|-100.96|-59.37|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-59.37|-100.96|<0.0001
72387094|NCT02761733|144282482|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-8.9703||||0.0343|TWO_SIDED|95.0|-17.2107|-0.7299||Least Squares Mean Difference Test using LSMEANS pdiff test in SAS PROC MIXED 9.4|Mixed Models Analysis|Satterthwaite adjusted df = 166|Satterthwaite adjusted df = 166|a priori test||-0.7299|-17.2107|.0343
72387095|NCT02761733|144282482|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.7297||||0.3126|TWO_SIDED|95.0|-3.4864|10.9458||Least Squares Mean Difference Test using LSMEANS pdiff test in SAS PROC MIXED 9.4|Mixed Models Analysis||Satterthwaite adjusted df = 163|a priori test||10.9458|-3.4864|.3126
72387096|NCT02761733|144282483|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1241||||0.584|TWO_SIDED|95.0|-0.5675|0.3193||a priori test|Mixed Models Analysis|Least Squares Mean Difference Test using LSMEANS pdiff test in SAS PROC MIXED 9.4|Satterthwaite adjusted df = 142|||.3193|-.5675|.5840
72387097|NCT02761733|144282483|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.2642||||0.2404|TWO_SIDED|95.0|-0.1754|0.7038||a priori test|Mixed Models Analysis|Least Squares Mean Difference Test using LSMEANS pdiff test in SAS PROC MIXED 9.4|Satterthwaite adjusted df = 184|||.7038|-.1754|.2404
72387098|NCT02761733|144282483|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.3192||||0.1074|TWO_SIDED|95.0|-0.0667|0.7051||a priori test|Mixed Models Analysis|Least Squares Mean Difference Test using LSMEANS pdiff test in SAS PROC MIXED 9.4|Satterthwaite adjusted df = 129|||.7051|-.0667|.1074
72387099|NCT02761733|144282483|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0576||||0.7677|TWO_SIDED|95.0|-0.3238|0.439||a priori test|Mixed Models Analysis|Least Squares Mean Difference Test using LSMEANS pdiff test in SAS PROC MIXED 9.4|Satterthwaite adjusted df = 131|||.4390|-.3238|.7677
72387100|NCT02761733|144282484|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.026||||0.9046|TWO_SIDED|95.0|-0.4507|0.3987||a priori test|Mixed Models Analysis|Least Squares Mean Difference Test using LSMEANS pdiff test in SAS PROC MIXED 9.4|Satterthwaite adjusted df = 182|||.3987|-.4507|.9046
72387101|NCT02761733|144282484|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.2258||||0.2518|TWO_SIDED|95.0|-0.1591|0.6107||a priori test|Mixed Models Analysis|Least Squares Mean Difference Test using LSMEANS pdiff test in SAS PROC MIXED 9.4|Satterthwaite adjusted df = 173|||.6107|-.1591|.2518
72387102|NCT02761733|144282484|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.437||||0.0338|TWO_SIDED|95.0|-0.837|-0.037||a priori test|Mixed Models Analysis|Least Squares Mean Difference Test using LSMEANS pdiff test in SAS PROC MIXED 9.4|Satterthwaite adjusted df = 165|||-.0370|-.8370|.0338
72387103|NCT02761733|144282484|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.2564||||0.1555|TWO_SIDED|95.0|-0.6086|0.0958||a priori test|Mixed Models Analysis|Least Squares Mean Difference Test using LSMEANS pdiff test in SAS PROC MIXED 9.4|Satterthwaite adjusted df = 157|||.0958|-.6086|.1555
72387104|NCT02761733|144282485|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.2967||||0.0283|TWO_SIDED|95.0|-0.5599|-0.0335||a priori test|Mixed Models Analysis|Least Squares Mean Difference Test using LSMEANS pdiff test in SAS PROC MIXED 9.4|Satterthwaite adjusted df = 213|||-.0335|-.5599|.0283
72387105|NCT02761733|144282485|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0401||||0.7407|TWO_SIDED|95.0|-0.1969|0.2771||a priori test|Mixed Models Analysis|Least Squares Mean Difference Test using LSMEANS pdiff test in SAS PROC MIXED 9.4|Satterthwaite adjusted df = 194|||.2771|-.1969|.7407
72387106|NCT02761733|144282485|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.2338||||0.0619|TWO_SIDED|95.0|-0.4778|0.0102||a priori test|Mixed Models Analysis|Least Squares Mean Difference Test using LSMEANS pdiff test in SAS PROC MIXED 9.4|Satterthwaite adjusted df = 186|||.0102|-.4778|.0619
72387107|NCT02761733|144282485|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.3793||||0.0009|TWO_SIDED|95.0|-0.599|-0.1596||a priori test|Mixed Models Analysis|Least Squares Mean Difference Test using LSMEANS pdiff test in SAS PROC MIXED 9.4|Satterthwaite adjusted df = 172|||-.1596|-.5990|.0009
72387108|NCT01961362|144282493|SUPERIORITY||Mean Difference (Net)|0.9|STANDARD_DEVIATION|0.87||0.6|TWO_SIDED|||||P\<0.05 considered to represent statistical significance.|t-test, 2 sided|||||||0.6
72387109|NCT01961362|144282493|SUPERIORITY||Mean Difference (Net)|-0.07|STANDARD_ERROR_OF_MEAN|1.2|<|0.05|TWO_SIDED||||||Mixed Models Analysis|||||||<0.05
72387110|NCT01961362|144282494|SUPERIORITY||Median Difference (Net)|-0.07|STANDARD_ERROR_OF_MEAN|1.2|<|0.05|TWO_SIDED||||||Mixed Models Analysis|||||||<0.05
72387111|NCT02149719|144282496|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||||||<0.0001
72387112|NCT01761175|144282524|SUPERIORITY_OR_OTHER||||||<|0.01|||||||Chi-squared|||||||<0.01
72387113|NCT01761175|144282525|SUPERIORITY_OR_OTHER||||||<|0.01|||||||Chi-squared|||||||<0.01
72387114|NCT01761175|144282526|SUPERIORITY_OR_OTHER||||||<|0.01|||||||Log Rank|||||||<0.01
72387115|NCT01761175|144282527|SUPERIORITY_OR_OTHER||||||<|0.01|||||||Log Rank|||||||<0.01
72387116|NCT01761175|144282528|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED||||||Chi-squared|||||||0.02
72387117|NCT01761175|144282529|SUPERIORITY_OR_OTHER||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||||||<0.01
72387118|NCT01761175|144282530|SUPERIORITY_OR_OTHER|||||||0.34|||||||Wilcoxon (Mann-Whitney)|||||||0.34
72387119|NCT03407625|144282563|SUPERIORITY||Risk Ratio (RR)|1.0||||0.86|TWO_SIDED|95.0|0.95|1.05|||log binomial regression||||We used generalized estimating equations for the log binomial regression with cluster entered as a random effect.|1.05|0.95|0.86
72387120|NCT04154930|144282587|SUPERIORITY||Treatment difference|69.7|||<|0.001|TWO_SIDED|95.0|52.54|86.89|||Cochran-Mantel-Haenszel|||||86.89|52.54|<0.001
72387121|NCT04154930|144282588|SUPERIORITY||Treatment difference|72.5|||<|0.001|TWO_SIDED|95.0|60.67|84.28|||Cochran-Mantel-Haenszel|||Responder Rate Based on the Blinded Evaluator's live assessment of the GIHS at 6 Months After Baseline||84.28|60.67|<0.001
72387122|NCT04154930|144282588|SUPERIORITY||Treatment difference|66.4|||<|0.001|TWO_SIDED|95.0|54.97|77.92|||Cochran-Mantel-Haenszel|||Responder Rate Based on the Blinded Evaluator's live assessment of the GIHS at 9 Months After Baseline||77.92|54.97|<0.001
72558953|NCT01243151|144647852|SUPERIORITY_OR_OTHER||LS Mean Difference|-83.0|STANDARD_ERROR_OF_MEAN|10.646|<|0.0001|TWO_SIDED|95.0|-104.14|-61.87|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-61.87|-104.14|<0.0001
72439678|NCT02528188|144393173|SUPERIORITY||Odds Ratio (OR)|1.07||||0.4406|TWO_SIDED|95.0|0.9|1.28|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 24: \>=50% reduction||1.28|0.90|0.4406
72439679|NCT02528188|144393173|SUPERIORITY||Odds Ratio (OR)|1.08||||0.4078|TWO_SIDED|95.0|0.9|1.29|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 24: \>=50% reduction||1.29|0.90|0.4078
72439680|NCT02528188|144393173|SUPERIORITY||Odds Ratio (OR)|1.08||||0.4071|TWO_SIDED|95.0|0.89|1.31|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 24: \>=70% reduction||1.31|0.89|0.4071
72439681|NCT02528188|144393173|SUPERIORITY||Odds Ratio (OR)|1.24||||0.0248|TWO_SIDED|95.0|1.03|1.5|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 24: \>=70% reduction||1.50|1.03|0.0248
72439682|NCT02528188|144393173|SUPERIORITY||Odds Ratio (OR)|0.88||||0.3641|TWO_SIDED|95.0|0.66|1.16|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 24: \>=90% reduction||1.16|0.66|0.3641
72439683|NCT02528188|144393173|SUPERIORITY||Odds Ratio (OR)|1.17||||0.2497|TWO_SIDED|95.0|0.89|1.53|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 24: \>=90% reduction||1.53|0.89|0.2497
72439684|NCT02528188|144393173|SUPERIORITY||Odds Ratio (OR)|1.02||||0.8682|TWO_SIDED|95.0|0.85|1.21|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 32: \>=30% reduction||1.21|0.85|0.8682
72439685|NCT02528188|144393173|SUPERIORITY||Odds Ratio (OR)|0.97||||0.7317|TWO_SIDED|95.0|0.81|1.16|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 32: \>=30% reduction||1.16|0.81|0.7317
72439686|NCT02528188|144393173|SUPERIORITY||Odds Ratio (OR)|1.04||||0.6493|TWO_SIDED|95.0|0.87|1.24|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 32: \>=50% reduction||1.24|0.87|0.6493
72439687|NCT02528188|144393173|SUPERIORITY||Odds Ratio (OR)|0.98||||0.7973|TWO_SIDED|95.0|0.82|1.17|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 32: \>=50% reduction||1.17|0.82|0.7973
72439688|NCT02528188|144393173|SUPERIORITY||Odds Ratio (OR)|1.19||||0.0757|TWO_SIDED|95.0|0.98|1.45|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 32: \>=70% reduction||1.45|0.98|0.0757
72439689|NCT02528188|144393173|SUPERIORITY||Odds Ratio (OR)|1.21||||0.0578|TWO_SIDED|95.0|0.99|1.47|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 32: \>=70% reduction||1.47|0.99|0.0578
72439690|NCT02528188|144393173|SUPERIORITY||Odds Ratio (OR)|1.02||||0.901|TWO_SIDED|95.0|0.76|1.37|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 32: \>=90% reduction||1.37|0.76|0.9010
72439691|NCT02528188|144393173|SUPERIORITY||Odds Ratio (OR)|1.32||||0.0548|TWO_SIDED|95.0|0.99|1.74|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 32: \>=90% reduction||1.74|0.99|0.0548
72439692|NCT02528188|144393173|SUPERIORITY||Odds Ratio (OR)|1.03||||0.7331|TWO_SIDED|95.0|0.86|1.23|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 40: \>=30% reduction||1.23|0.86|0.7331
72495731|NCT03434379|144520791|SUPERIORITY||Hazard Ratio (HR)|0.33||||0.3477|TWO_SIDED|95.0|0.03|3.69|||Log Rank|||Stratified by macrovascular invasion and/or extrahepatic spread (presence vs. absence), and baseline AFP (\<400 vs. \>/= 400 ng/mL).||3.69|0.03|0.3477
72558954|NCT01243151|144647852|SUPERIORITY_OR_OTHER||LS Mean Difference|-104.77|STANDARD_ERROR_OF_MEAN|10.656|<|0.0001|TWO_SIDED|95.0|-125.91|-83.62|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-83.62|-125.91|<0.0001
72439693|NCT02528188|144393173|SUPERIORITY||Odds Ratio (OR)|0.98||||0.8632|TWO_SIDED|95.0|0.82|1.18|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 40: \>=30% reduction||1.18|0.82|0.8632
72439694|NCT02528188|144393173|SUPERIORITY||Odds Ratio (OR)|1.04||||0.6262|TWO_SIDED|95.0|0.88|1.25|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 40: \>=50% reduction||1.25|0.88|0.6262
72439695|NCT02528188|144393173|SUPERIORITY||Odds Ratio (OR)|0.96||||0.6817|TWO_SIDED|95.0|0.81|1.15|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 40: \>=50% reduction||1.15|0.81|0.6817
72439696|NCT02528188|144393173|SUPERIORITY||Odds Ratio (OR)|1.03||||0.799|TWO_SIDED|95.0|0.85|1.24|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 40: \>=70% reduction||1.24|0.85|0.7990
72439697|NCT02528188|144393173|SUPERIORITY||Odds Ratio (OR)|1.04||||0.6786|TWO_SIDED|95.0|0.86|1.26|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 40: \>=70% reduction||1.26|0.86|0.6786
72439698|NCT02528188|144393173|SUPERIORITY||Odds Ratio (OR)|1.04||||0.8069|TWO_SIDED|95.0|0.78|1.38|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 40: \>=90% reduction||1.38|0.78|0.8069
72439699|NCT02528188|144393173|SUPERIORITY||Odds Ratio (OR)|1.16||||0.2951|TWO_SIDED|95.0|0.88|1.54|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 40: \>=90% reduction||1.54|0.88|0.2951
72439700|NCT02528188|144393173|SUPERIORITY||Odds Ratio (OR)|1.01||||0.9093|TWO_SIDED|95.0|0.85|1.21|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 48: \>=30% reduction||1.21|0.85|0.9093
72558955|NCT01243151|144647852|SUPERIORITY_OR_OTHER||LS Mean Difference|-90.23|STANDARD_ERROR_OF_MEAN|10.381|<|0.0001|TWO_SIDED|95.0|-110.84|-69.63|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-69.63|-110.84|<0.0001
72439701|NCT02528188|144393173|SUPERIORITY||Odds Ratio (OR)|0.94||||0.5032|TWO_SIDED|95.0|0.79|1.12|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 48: \>=30% reduction||1.12|0.79|0.5032
72439702|NCT02528188|144393173|SUPERIORITY||Odds Ratio (OR)|1.07||||0.4382|TWO_SIDED|95.0|0.9|1.28|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 48: \>=50% reduction||1.28|0.90|0.4382
72439703|NCT02528188|144393173|SUPERIORITY||Odds Ratio (OR)|0.95||||0.5638|TWO_SIDED|95.0|0.79|1.13|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 48: \>=50% reduction||1.13|0.79|0.5638
72439704|NCT02528188|144393173|SUPERIORITY||Odds Ratio (OR)|1.05||||0.6436|TWO_SIDED|95.0|0.86|1.27|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 48: \>=70% reduction||1.27|0.86|0.6436
72618996|NCT03615534|144768404|SUPERIORITY|||||||0.001||||||Results were evaluated in terms of adjusted end line RC levels, embracing the least significant difference (LSD) for pair-wise comparison. Probability of less than 0.05 was considered statistically significant.|MANCOVA|Covariates appearing in MANCOVA model are evaluated at the following baseline values:RC=48.9,TC=199.9, Non HDL-C=168.0, d-LDL-C=119.1, ApoB=133.1mg/dl||Multivariate Analysis of Covariance (MANCOVA), was applied to assess treatment effects among different arms, comprising the influence of the baseline RC level as a covariate, with further adjustments for baselineTC, Non HDL-C, d-LDL-C, and ApoB.||||0.001
72439705|NCT02528188|144393173|SUPERIORITY||Odds Ratio (OR)|1.04||||0.706|TWO_SIDED|95.0|0.85|1.26|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 48: \>=70% reduction||1.26|0.85|0.7060
72439706|NCT02528188|144393173|SUPERIORITY||Odds Ratio (OR)|0.96||||0.7729|TWO_SIDED|95.0|0.72|1.28|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 48: \>=90% reduction||1.28|0.72|0.7729
72495732|NCT03434379|144520792|SUPERIORITY||Hazard Ratio (HR)|0.59||||0.0103|TWO_SIDED|95.0|0.4|0.89|||Log Rank|||Stratified by macrovascular invasion and/or extrahepatic spread (presence vs. absence), and baseline AFP (\<400 vs. \>/= 400 ng/mL).||0.89|0.40|0.0103
72558956|NCT01243151|144647852|SUPERIORITY_OR_OTHER||LS Mean Difference|-71.54|STANDARD_ERROR_OF_MEAN|10.479|<|0.0001|TWO_SIDED|95.0|-92.34|-50.75|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-50.75|-92.34|<0.0001
72387123|NCT04154930|144282588|SUPERIORITY||Treatment difference|52.4|||<|0.001|TWO_SIDED|95.0|40.57|64.26|||Cochran-Mantel-Haenszel|||Responder Rate Based on the Blinded Evaluator's live assessment of the GIHS at 12 Months After Baseline||64.26|40.57|<0.001
72387124|NCT03104543|144282591|SUPERIORITY||Risk Ratio (RR)|0.99||||0.05|TWO_SIDED|95.0|0.67|1.45|||Generalized estimating equation|||||1.45|0.67|.05
72387125|NCT03104543|144282594|SUPERIORITY||Mean Difference (Final Values)|-0.09||||0.05|TWO_SIDED|95.0|-0.47|0.28|||t-test, 2 sided|||||0.28|-0.47|.05
72387126|NCT00806351|144282599|SUPERIORITY_OR_OTHER||Risk Difference|-27.3|||||TWO_SIDED|95.0|-80.9|40.3||||||The 95 percent confidence interval (95% CI) was calculated using the method of exact unconditional confidence limits for the difference. Global response (rates of success) by using a 2-sided 95% CI for the true difference in efficacy (Anidulafungin minus Caspofungin) was calculated. Statistical testing was done at 2.5% alpha.||40.3|-80.9|
72387127|NCT00806351|144282600|SUPERIORITY_OR_OTHER||Risk Difference|-27.3|||||TWO_SIDED|95.0|-80.9|40.3||||||The 95% CI was calculated using the method of exact unconditional confidence limits for the difference. Global response (rates of success) by using a 2-sided 95% CI for the true difference in efficacy (Anidulafungin minus Caspofungin) was calculated. Statistical testing was done at 2.5% alpha.||40.3|-80.9|
72387128|NCT00806351|144282601|SUPERIORITY_OR_OTHER||Risk Difference|-40.0|||||TWO_SIDED|95.0|-97.5|63.9||||||The 95% CI was calculated using the method of exact unconditional confidence limits for the difference. Global response (rates of success) by using a 2-sided 95% CI for the true difference in efficacy (Anidulafungin minus Caspofungin) was calculated. Statistical testing was done at 2.5% alpha.||63.9|-97.5|
72387129|NCT00806351|144282602|SUPERIORITY_OR_OTHER||Risk Difference|-50.0|||||TWO_SIDED|95.0|-97.5|55.0||||||The 95% CI was calculated using the method of exact unconditional confidence limits for the difference. Global response (rates of success) by using a 2-sided 95% CI for the true difference in efficacy (Anidulafungin minus Caspofungin) was calculated. Statistical testing was done at 2.5% alpha.||55.0|-97.5|
72387130|NCT00806351|144282607|SUPERIORITY_OR_OTHER||Risk Difference|-36.4|||||TWO_SIDED|95.0|-90.6|31.9||||||The 95% CI was calculated using the method of exact unconditional confidence limits for the difference. Global response (rates of success) by using a 2-sided 95% CI for the true difference in efficacy (Anidulafungin minus Caspofungin) was calculated. Statistical testing was done at 2.5% alpha.||31.9|-90.6|
72387131|NCT00134030|144282625|SUPERIORITY||Hazard Ratio (HR)|0.83||||0.214|TWO_SIDED|95.0|0.61|1.12|||Log Rank|||||1.12|0.61|0.214
72387132|NCT00134030|144282625|SUPERIORITY||Hazard Ratio (HR)|0.98||||0.86|TWO_SIDED|95.0|0.78|1.23|||Log Rank|||||1.23|0.78|0.86
72387133|NCT00134030|144282625|SUPERIORITY||Mean Difference (Final Values)|0.8||||0.69|TWO_SIDED|95.0|-3.3|4.9|||Difference in RMST|||Secondary RMST analysis performed in poor response group, due to evidence of non-proportional hazards.||4.9|-3.3|0.69
72387134|NCT00134030|144282626|SUPERIORITY||Hazard Ratio (HR)|0.96||||0.804|TWO_SIDED|95.0|0.69|1.33|||Log Rank|||||1.33|0.69|0.804
72387135|NCT00134030|144282626|SUPERIORITY||Hazard Ratio (HR)|1.06||||0.674|TWO_SIDED|95.0|0.81|1.39|||Log Rank|||||1.39|0.81|0.674
72387136|NCT01435603|144282632|SUPERIORITY||Slope|-1.273||||0.017|TWO_SIDED||||||Regression, Linear|||||||0.017
72387137|NCT01682954|144282659|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANOVA|||||||<0.0001
72387138|NCT01682954|144282660|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANOVA|||||||<0.0001
72387139|NCT00667875|144282661|SUPERIORITY|||||||0.49||||||The p value represents variation of the total 16 week trial over all three groups.|Mixed Models Analysis|||Analyzed as a mixed model, Group by time (4 time blocks) with an unstructured variance/covariance matrix. Baseline drinks per day was used as a covariate.||||0.49
72387140|NCT00667875|144282662|SUPERIORITY|||||||0.03||||||The p value represents variation of the total 16 week trial over all three groups.|Mixed Models Analysis|||Analyzed as a mixed model (SPSS linear mixed) with an unstructured variance/covariance and baseline percent heavy drinking days as a covariate||||0.03
72387141|NCT00667875|144282663|SUPERIORITY|Anova across all three treatment groups|||||<|0.05|||||||ANOVA|Naltrexone or naltrexone placebo pills taken F=3.9 df 2 Aripiprazole or aripiprazole placebo pills taken F=4.6 df 2||||||<.05
72387142|NCT00667875|144282664|SUPERIORITY||||||<|0.05|||||||ANOVA|f 3.2 df 2||Anova across three groups||||<.05
72387143|NCT01696071|144282670|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.002|STANDARD_ERROR_OF_MEAN|0.018||||95.0|-0.038|0.034|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline|Tio R5 QD - Tio R2.5 BID|No p-values are presented as no formal statistical hypothesis was tested.||0.034|-0.038|
72387144|NCT01696071|144282671|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.021||||95.0|-0.032|0.052|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline|Tio R5 qd - Tio R2.5 bid|No p-values are presented as no formal statistical hypothesis was tested.||0.052|-0.032|
72387145|NCT01696071|144282672|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.014|STANDARD_ERROR_OF_MEAN|0.018||||95.0|-0.05|0.022|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline|Tio R5 qd - Tio R2.5 bid|No p-values are presented as no formal statistical hypothesis was tested||0.022|-0.050|
72387146|NCT01696071|144282673|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.014|STANDARD_ERROR_OF_MEAN|0.018||||95.0|-0.051|0.023|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline|Tio R5 qd - Tio R2.5 bid|No p-values are presented as no formal statistical hypothesis was tested.||0.023|-0.051|
72387147|NCT01696071|144282674|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.004|STANDARD_ERROR_OF_MEAN|0.032||||95.0|-0.06|0.068|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline|Tio R5 qd - Tio R2.5 bid|No p-values are presented as no formal statistical hypothesis was tested.||0.068|-0.060|
72387148|NCT01696071|144282675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.005|STANDARD_ERROR_OF_MEAN|0.02||||95.0|-0.044|0.035|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline|Tio R5 qd - Tio R2.5 bid|No p-values are presented as no formal statistical hypothesis was tested.||0.035|-0.044|
72387149|NCT01696071|144282676|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.003|STANDARD_ERROR_OF_MEAN|0.023||||95.0|-0.048|0.042|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline|Tio R5 qd - Tio R2.5 bid|No p-values are presented as no formal statistical hypothesis was tested||0.042|-0.048|
72387150|NCT01696071|144282677|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.006|STANDARD_ERROR_OF_MEAN|0.02||||95.0|-0.047|0.034|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline|Tio R5 qd - Tio R2.5 bid|No p-values are presented as no formal statistical hypothesis was tested||0.034|-0.047|
72558957|NCT01243151|144647852|SUPERIORITY_OR_OTHER||LS Mean Difference|-74.46|STANDARD_ERROR_OF_MEAN|10.646|<|0.0001|TWO_SIDED|95.0|-95.59|-53.32|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-53.32|-95.59|<0.0001
72558958|NCT01243151|144647852|SUPERIORITY_OR_OTHER||LS Mean Difference|-102.35|STANDARD_ERROR_OF_MEAN|10.656|<|0.0001|TWO_SIDED|95.0|-123.49|-81.21|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-81.21|-123.49|<0.0001
72558959|NCT01243151|144647852|SUPERIORITY_OR_OTHER||LS Mean Difference|-87.15|STANDARD_ERROR_OF_MEAN|10.381|<|0.0001|TWO_SIDED|95.0|-107.76|-66.55|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-66.55|-107.76|<0.0001
72558960|NCT01243151|144647853|SUPERIORITY_OR_OTHER||LS Mean Difference|2.01|STANDARD_ERROR_OF_MEAN|1.945||0.3064|TWO_SIDED|95.0|-1.89|5.9|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||5.90|-1.89|0.3064
72558961|NCT01243151|144647853|SUPERIORITY_OR_OTHER||LS Mean Difference|2.67|STANDARD_ERROR_OF_MEAN|2.025||0.1922|TWO_SIDED|95.0|-1.38|6.73|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||6.73|-1.38|0.1922
72558962|NCT01243151|144647853|SUPERIORITY_OR_OTHER||LS Mean Difference|0.82|STANDARD_ERROR_OF_MEAN|1.984||0.6827|TWO_SIDED|95.0|-3.16|4.79|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||4.79|-3.16|0.6827
72558963|NCT01243151|144647853|SUPERIORITY_OR_OTHER||LS Mean Difference|2.45|STANDARD_ERROR_OF_MEAN|1.981||0.2211|TWO_SIDED|95.0|-1.52|6.42|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||6.42|-1.52|0.2211
72558964|NCT01243151|144647853|SUPERIORITY_OR_OTHER||LS Mean Difference|6.64|STANDARD_ERROR_OF_MEAN|2.158||0.0033|TWO_SIDED|95.0|2.31|10.97|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||10.97|2.31|0.0033
72558965|NCT01243151|144647853|SUPERIORITY_OR_OTHER||LS Mean Difference|5.09|STANDARD_ERROR_OF_MEAN|2.237||0.0269|TWO_SIDED|95.0|0.6|9.57|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||9.57|0.60|0.0269
72387151|NCT01696071|144282678|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.019|STANDARD_ERROR_OF_MEAN|0.026||||95.0|-0.07|0.032|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline|Tio R5 qd - Tio R2.5 bid|No p-values are presented as no formal statistical hypothesis was tested||0.032|-0.070|
72387152|NCT01696071|144282679|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.041|STANDARD_ERROR_OF_MEAN|0.035||||95.0|-0.03|0.111|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline|Tio R5 qd - Tio R2.5 bid|No p-values are presented as no formal statistical hypothesis was tested||0.111|-0.030|
72387153|NCT01696071|144282680|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.389|STANDARD_ERROR_OF_MEAN|3.658||||95.0|-8.651|5.873|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline|Tio R5 qd - Tio R2.5 bid|No p-values are presented as no formal statistical hypothesis was tested||5.873|-8.651|
72387154|NCT03320057|144282713|OTHER|We conducted multivariable logistic regression analyses using Generalized Estimating Equation (GEE) models to assess whether study implementation was associated with pharmacists' overall medication abortion knowledge. Multivariable GEE analyses included time period (baseline and endline) as the primary independent variable, adjusted for gender and years of experience, and accounted for clustering by pharmacy site and individual pharmacist.|Beta Coefficient|0.14|||<|0.05|TWO_SIDED|95.0|0.11|0.17|||Regression, Linear||Coefficients in adjusted analyses examining overall medication abortion knowledge represent the difference in mean knowledge scores between baseline and endline.|Medication abortion knowledge scores were based on a set of 15 items. We first assessed the internal consistency reliability of the 15 knowledge items and considered a Cronbach's alpha coefficient above .70 to be acceptable to examine the items as a combined score.||0.17|0.11|<0.05
72387155|NCT00717093|144282725|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.39|||<|0.0001|TWO_SIDED|95.0|1.59|3.58||p-values obtained from logistic regression model including main effects of treatment and center|Regression, Logistic|Missing salivary cotinine values imputed as negative|Odds ratio obtained from logistic regression model including main effects of treatment and center|||3.58|1.59|<0.0001
72387156|NCT00717093|144282726|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.7||||0.0118|TWO_SIDED|95.0|1.12|2.58||p-value obtained from a logistic regression model including the main effects of treatment and center|Regression, Logistic|Missing salivary cotinine values were imputed as negative|Odds Ratio obtained from a logistic regression model including the main effects of treatment and center|Week 26||2.58|1.12|0.0118
72387157|NCT00717093|144282727|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.77||||0.0063|TWO_SIDED|95.0|1.17|2.67|||Regression, Logistic|Missing salivary cotinine values were imputed as negative.||||2.67|1.17|0.0063
72387158|NCT00717093|144282728|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.28|||<|0.0001|TWO_SIDED|95.0|1.52|3.41||p-value obtained from a logistic regression model including the main effects of treatment and center|Regression, Logistic|Missing salivary cotinine was imputed as negative|Odds ratio obtained from a logistic regression model including the main effects of treatment and center|Week 12||3.41|1.52|<0.0001
72495733|NCT03434379|144520793|SUPERIORITY||Hazard Ratio (HR)|0.49||||0.0002|TWO_SIDED|95.0|0.33|0.71|||Log Rank|||Stratified by macrovascular invasion and/or extrahepatic spread (presence vs. absence), and baseline AFP (\<400 vs. \>/= 400 ng/mL).||0.71|0.33|0.0002
72558966|NCT01243151|144647853|SUPERIORITY_OR_OTHER||LS Mean Difference|3.87|STANDARD_ERROR_OF_MEAN|2.232||0.089|TWO_SIDED|95.0|-0.61|8.34|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||8.34|-0.61|0.0890
72387159|NCT00717093|144282728|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.42||||0.0919|TWO_SIDED|95.0|0.94|2.13||p-value obtained from a logistic regression model including the main effects of treatment and center|Regression, Logistic|Missing salivary cotinine was imputed as negative|Odds ratio obtained from a logistic regression model including the main effects of treatment and center|Week 26||2.13|0.94|0.0919
72387160|NCT01650844|144282744|OTHER|We estimated the power to detect the smallest clinically significant difference in mean SFDs post intervention between the groups, accounting for repeated measures. A sample of 400 obtains greater than 90% power to detect a difference of 0.8 SFD per 2 weeks or greater. Analyses were multivariable modified intention to treat, including all participants with post intervention data. Generalized estimating equation (GEE) models were fitted with repeated asthma outcomes.|Mean Difference (Net)|0.8|STANDARD_DEVIATION|2.8|<|0.05|TWO_SIDED|||||Analyses were multivariable modified intention to treat, including all participants with post intervention data. Generalized estimating equation (GEE) models were fitted with repeated asthma outcomes.|Regression, Linear|||||||<0.05
72387161|NCT00316719|144282745|NON_INFERIORITY_OR_EQUIVALENCE|This is a Non-inferiority Analysis with the margin of -1.0.|Mean Difference (Net)|-0.33|STANDARD_ERROR_OF_MEAN|0.309|<|0.001||95.0|-0.94|0.28|||ANCOVA|||||0.28|-0.94|<0.001
72387162|NCT02903355|144282765|SUPERIORITY|||||||0.4385|||||||Fisher Exact|||||||.4385
72387163|NCT02903355|144282766|SUPERIORITY|||||||0.5562|||||||Fisher Exact|||||||.5562
72387164|NCT02903355|144282767|SUPERIORITY|||||||0.5441|||||||Fisher Exact|||||||.5441
72387165|NCT02903355|144282768|SUPERIORITY|||||||0.3666|||||||Fisher Exact|||||||.3666
72387166|NCT02903355|144282769|SUPERIORITY|||||||0.4446|||||||Fisher Exact|||||||.4446
72387167|NCT02903355|144282770|SUPERIORITY|||||||0.5431|||||||Fisher Exact|||||||.5431
72558967|NCT01243151|144647853|SUPERIORITY_OR_OTHER||LS Mean Difference|5.08|STANDARD_ERROR_OF_MEAN|2.19||0.0242|TWO_SIDED|95.0|0.69|9.47|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||9.47|0.69|0.0242
72387168|NCT02903355|144282771|SUPERIORITY|||||||0.7409|||||||Fisher Exact|||||||.7409
72387169|NCT02903355|144282772|SUPERIORITY|||||||0.1597|||||||Fisher Exact|||||||.1597
72387170|NCT02903355|144282773|SUPERIORITY|||||||0.2784|||||||t-test, 1 sided|||||||.2784
72387171|NCT02903355|144282774|SUPERIORITY|||||||0.2303|||||||Fisher Exact|||||||.2303
72387172|NCT02468674|144282775|OTHER|||||||0.759|||||||t-test, 1 sided|One-sided test at the 0.025 significance level.||Population I: SPPB total score at Week 49||||0.759
72387173|NCT02468674|144282775|OTHER|||||||0.5|||||||t-test, 1 sided|One-sided test at the 0.025 significance level.||Population I: SPPB total score at Week 49||||0.500
72387174|NCT02468674|144282775|OTHER|||||||0.144|||||||t-test, 1 sided|One-sided test at the 0.025 significance||Population I: SPPB total score at Week 49||||0.144
72495734|NCT03434379|144520794|SUPERIORITY||Hazard Ratio (HR)|0.68||||0.0927|TWO_SIDED|95.0|0.43|1.07|||Log Rank|||Stratified by macrovascular invasion and/or extrahepatic spread (presence vs. absence), and baseline AFP (\<400 vs. \>/= 400 ng/mL).||1.07|0.43|0.0927
72387175|NCT02468674|144282775|OTHER|||||||0.648|||||||t-test, 1 sided|One-sided test at the 0.025 significance level.||Population I: SPPB total score at Week 49||||0.648
72387176|NCT02468674|144282775|OTHER|||||||0.929|||||||t-test, 1 sided|One-sided test at the 0.025 significance||Population I: SPPB total score at Week 49||||0.929
72387177|NCT02468674|144282775|OTHER|||||||0.53|||||||t-test, 1 sided|One-sided test at the 0.025 significance||Population I: SPPB total score at Week 49||||0.530
72387178|NCT02468674|144282776|OTHER|||||||0.839|||||||ANCOVA|Difference in the least square means (SE)||Population II: SPPB total score at Week 49||||0.839
72387179|NCT02468674|144282777|OTHER|||||||0.669|||||||t-test, 1 sided|One-sided test at the 0.025 significance level.||Population I: 6MWT at Week 49||||0.669
72387180|NCT02468674|144282777|OTHER|||||||0.773|||||||t-test, 1 sided|One-sided test at the 0.025 significance level.||Population I: 6MWT at Week 49||||0.773
72387181|NCT02468674|144282777|OTHER|||||||0.29|||||||t-test, 1 sided|One-sided test at the 0.025 significance level.||Population I: 6MWT at Week 49||||0.290
72387182|NCT02468674|144282777|OTHER|||||||0.766|||||||t-test, 1 sided|One-sided test at the 0.025 significance level.||Population I: 6MWT at Week 49||||0.766
72387183|NCT02468674|144282777|OTHER|||||||0.885|||||||t-test, 1 sided|One-sided test at the 0.025 significance level.||Population I: 6MWT at Week 49||||0.885
72387184|NCT02468674|144282777|OTHER|||||||0.84|||||||t-test, 1 sided|One-sided test at the 0.025 significance level.||Population I: 6MWT at Week 49||||0.840
72387185|NCT02468674|144282778|OTHER|||||||0.367|||||||ANCOVA|Difference in the least square means (SE)||Population II: 6MWT at Week 49||||0.367
72387186|NCT02468674|144282779|OTHER|||||||0.875|||||||t-test, 1 sided|One-sided test at the 0.025 significance||Population I: Gait speed at Week 49||||0.875
72387187|NCT02468674|144282779|OTHER|||||||0.909|||||||t-test, 1 sided|One-sided test at the 0.025 significance||Population I: Gait speed at Week 49||||0.909
72387188|NCT02468674|144282779|OTHER|||||||0.168|||||||t-test, 1 sided|One-sided test at the 0.025 significance||Population I: Gait speed at Week 49||||0.168
72387189|NCT02468674|144282779|OTHER|||||||0.632|||||||t-test, 1 sided|One-sided test at the 0.025 significance||Population I: Gait speed at Week 49||||0.632
72387190|NCT02468674|144282779|OTHER|||||||0.31|||||||t-test, 1 sided|One-sided test at the 0.025 significance||Population I: Gait speed at Week 49||||0.310
72387191|NCT02468674|144282779|OTHER|||||||0.321|||||||t-test, 1 sided|One-sided test at the 0.025 significance||Population I: Gait speed at Week 49||||0.321
72558968|NCT01243151|144647853|SUPERIORITY_OR_OTHER||LS Mean Difference|3.25|STANDARD_ERROR_OF_MEAN|2.101||0.127|TWO_SIDED|95.0|-0.95|7.46|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||7.46|-0.95|0.1270
72558969|NCT01243151|144647853|SUPERIORITY_OR_OTHER||LS Mean Difference|3.4|STANDARD_ERROR_OF_MEAN|2.151||0.1199|TWO_SIDED|95.0|-0.91|7.7|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||7.70|-0.91|0.1199
72558970|NCT01243151|144647853|SUPERIORITY_OR_OTHER||LS Mean Difference|0.51|STANDARD_ERROR_OF_MEAN|2.15||0.8123|TWO_SIDED|95.0|-3.79|4.82|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||4.82|-3.79|0.8123
72558971|NCT01243151|144647853|SUPERIORITY_OR_OTHER||LS Mean Difference|5.65|STANDARD_ERROR_OF_MEAN|2.106||0.0095|TWO_SIDED|95.0|1.44|9.87|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||9.87|1.44|0.0095
72558972|NCT01243151|144647853|SUPERIORITY_OR_OTHER||LS Mean Difference|4.0|STANDARD_ERROR_OF_MEAN|2.492||0.1141|TWO_SIDED|95.0|-0.99|8.99|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||8.99|-0.99|0.1141
72558973|NCT01243151|144647853|SUPERIORITY_OR_OTHER||LS Mean Difference|3.65|STANDARD_ERROR_OF_MEAN|2.536||0.1552|TWO_SIDED|95.0|-1.42|8.73|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||8.73|-1.42|0.1552
72439707|NCT02528188|144393173|SUPERIORITY||Odds Ratio (OR)|1.07||||0.6405|TWO_SIDED|95.0|0.81|1.42|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 48: \>=90% reduction||1.42|0.81|0.6405
72558974|NCT01243151|144647853|SUPERIORITY_OR_OTHER||LS Mean Difference|1.57|STANDARD_ERROR_OF_MEAN|2.547||0.5407|TWO_SIDED|95.0|-3.53|6.67|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||6.67|-3.53|0.5407
72558975|NCT01243151|144647853|SUPERIORITY_OR_OTHER||LS Mean Difference|6.56|STANDARD_ERROR_OF_MEAN|2.485||0.0107|TWO_SIDED|95.0|1.58|11.53|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||11.53|1.58|0.0107
72558976|NCT01243151|144647854|SUPERIORITY_OR_OTHER||LS Mean Difference|-60.35|STANDARD_ERROR_OF_MEAN|8.152|<|0.0001|TWO_SIDED|95.0|-76.74|-43.97|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-43.97|-76.74|<0.0001
72387192|NCT02468674|144282780|OTHER|||||||0.395|||||||ANCOVA|Difference in the least square means (SE)||Population II: Gait speed at Week 49||||0.395
72387193|NCT02468674|144282781|OTHER|||||||0.12|||||||t-test, 1 sided|One-sided test at the 0.025 significance level.||Population I: ASMI at Week 49||||0.120
72387194|NCT02468674|144282781|OTHER|||||||0.297|||||||t-test, 1 sided|One-sided test at the 0.025 significance level.||Population I: ASMI at Week 49||||0.297
72387195|NCT02468674|144282781|OTHER|||||||0.074|||||||t-test, 1 sided|One-sided test at the 0.025 significance level.||Population I: ASMI at Week 49||||0.074
72387196|NCT02468674|144282781|OTHER|||||||0.022|||||||t-test, 1 sided|One-sided test at the 0.025 significance level.||Population I: ASMI at Week 49||||0.022
72387197|NCT02468674|144282781|OTHER|||||||0.106|||||||t-test, 1 sided|One-sided test at the 0.025 significance level.||Population I: ASMI at Week 49||||0.106
72495735|NCT03434379|144520795|SUPERIORITY||Hazard Ratio (HR)|0.67||||0.0861|TWO_SIDED|95.0|0.43|1.06|||Log Rank|||Stratified by macrovascular invasion and/or extrahepatic spread (presence vs. absence), and baseline AFP (\<400 vs. \>/= 400 ng/mL).||1.06|0.43|0.0861
72558977|NCT01243151|144647854|SUPERIORITY_OR_OTHER||LS Mean Difference|-52.53|STANDARD_ERROR_OF_MEAN|8.422|<|0.0001|TWO_SIDED|95.0|-69.45|-35.61|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-35.61|-69.45|<0.0001
72387198|NCT02468674|144282781|OTHER|||||||0.211|||||||t-test, 1 sided|One-sided test at the 0.025 significance level.||Population I: ASMI at Week 49||||0.211
72387199|NCT02468674|144282782|OTHER|||||||1|||||||ANCOVA|Difference in the least square geometric means||Population II: ASMI at Week 49||||1.000
72387200|NCT02468674|144282783|OTHER|||||||0.084|||||||t-test, 1 sided|One-sided test at the 0.025 significance level.||Population I: LBM at Week 49||||0.084
72387201|NCT02468674|144282783|OTHER|||||||0.283|||||||t-test, 1 sided|One-sided test at the 0.025 significance level.||Population I: LBM at Week 49||||0.283
72387202|NCT02468674|144282783|OTHER|||||||0.323|||||||t-test, 1 sided|One-sided test at the 0.025 significance level.||Population I: LBM at Week 49||||0.323
72387203|NCT02468674|144282783|OTHER|||||||0.018|||||||t-test, 1 sided|One-sided test at the 0.025 significance level.||Population I: LBM at Week 49||||0.018
72387204|NCT02468674|144282783|OTHER|||||||0.179|||||||t-test, 1 sided|One-sided test at the 0.025 significance level.||Population I: LBM at Week 49||||0.179
72387205|NCT02468674|144282783|OTHER|||||||0.227|||||||t-test, 1 sided|One-sided test at the 0.025 significance level.||Population I: LBM at Week 49||||0.227
72558978|NCT01243151|144647854|SUPERIORITY_OR_OTHER||LS Mean Difference|-69.46|STANDARD_ERROR_OF_MEAN|8.26|<|0.0001|TWO_SIDED|95.0|-86.06|-52.86|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-52.86|-86.06|<0.0001
72387206|NCT02468674|144282784|OTHER|||||||1|||||||ANCOVA|Difference in the least square geometric means||Population II: LBM at Week 49||||1.000
72387207|NCT00094172|144282808|SUPERIORITY_OR_OTHER|||||||0.929|||||||Log Rank|||This is the primary analysis of the primary endpoint||||0.929
72387208|NCT00094172|144282808|SUPERIORITY_OR_OTHER|||||||0.823|||||||Fisher Exact|||This is the secondary analysis of the primary endpoint||||0.823
72387209|NCT00094172|144282809|SUPERIORITY_OR_OTHER|||||||0.208|||||||Log Rank|||||||.208
72387210|NCT00094172|144282810|SUPERIORITY_OR_OTHER|||||||0.526||95.0|||||Log Rank|||||||0.526
72387211|NCT03689530|144282814|SUPERIORITY|||||||0.7436|||||||Mixed Models Analysis|||Outcomes were analyzed using multilevel models adapted for partially clustered data. Analyses was done in SAS v9.4||||0.7436
72387212|NCT03689530|144282815|SUPERIORITY|||||||0.1212|||||||Mixed Models Analysis|||Outcomes were analyzed using multilevel models adapted for partially clustered data. Analyses was done in SAS v9.4||||0.1212
72387213|NCT03689530|144282816|SUPERIORITY|||||||0.8839|||||||Mixed Models Analysis|||Outcomes were analyzed using multilevel models adapted for partially clustered data. Analyses was done in SAS v9.4||||0.8839
72387214|NCT03689530|144282817|SUPERIORITY|||||||0.1137|||||||Mixed Models Analysis|||Outcomes were analyzed using multilevel models adapted for partially clustered data. Analyses was done in SAS v9.4||||0.1137
72387215|NCT03689530|144282818|SUPERIORITY|||||||0.0162|||||||Mixed Models Analysis|||Outcomes were analyzed using multilevel models adapted for partially clustered data. Analyses was done in SAS v9.4||||0.0162
72387216|NCT03689530|144282820|SUPERIORITY|||||||0.2117|||||||Mixed Models Analysis|||Outcomes were analyzed using multilevel models adapted for partially clustered data. Analyses was done in SAS v9.4||||0.2117
72387217|NCT03689530|144282821|SUPERIORITY|||||||0.4169|||||||Mixed Models Analysis|||||||0.4169
72387218|NCT03689530|144282822|SUPERIORITY|||||||0.8785|||||||Mixed Models Analysis|||Outcomes were analyzed using multilevel models adapted for partially clustered data. Analyses was done in SAS v9.4||||0.8785
72387219|NCT03689530|144282823|SUPERIORITY|||||||0.1006|||||||Mixed Models Analysis|||Outcomes were analyzed using multilevel models adapted for partially clustered data. Analyses was done in SAS v9.4||||0.1006
72387220|NCT03689530|144282824|SUPERIORITY|||||||0.7168|||||||Mixed Models Analysis|||||||0.7168
72387221|NCT03689530|144282825|SUPERIORITY|||||||0.0001|||||||Mixed Models Analysis|||Outcomes were analyzed using multilevel models adapted for partially clustered data. Analyses was done in SAS v9.4||||0.0001
72387222|NCT03689530|144282826|OTHER|Single group analysis for peer support group only|Mean|3.799|STANDARD_DEVIATION|0.885|||TWO_SIDED|||||||||||||
72387223|NCT03689530|144282827|OTHER|Single group analysis for peer support group only|Mean|3.732|STANDARD_DEVIATION|0.985|||TWO_SIDED|||||||||||||
72387224|NCT03689530|144282828|OTHER|Single group analysis for peer support group only|Mean|6.222|STANDARD_DEVIATION|1.083|||TWO_SIDED|||||||||||||
72387225|NCT03689530|144282829|OTHER|Single group analysis for peer support group only|Mean|6.179|STANDARD_DEVIATION|1.141|||TWO_SIDED|||||||||||||
72387226|NCT03689530|144282830|SUPERIORITY|||||||0.9126|||||||Mixed Models Analysis|||||||0.9126
72387227|NCT03689530|144282831|SUPERIORITY|||||||0.7405|||||||Mixed Models Analysis|||||||0.7405
72387228|NCT03689530|144282832|SUPERIORITY|||||||0.5956|||||||Mixed Models Analysis|||||||0.5956
72387229|NCT03689530|144282833|SUPERIORITY|||||||0.3341|||||||Mixed Models Analysis|||||||0.3341
72387230|NCT03689530|144282834|SUPERIORITY|||||||0.2049|||||||Mixed Models Analysis|||||||0.2049
72387231|NCT03689530|144282835|SUPERIORITY|||||||0.0335|||||||Mixed Models Analysis|||||||0.0335
72387232|NCT03689530|144282836|SUPERIORITY|||||||0.3219|||||||Mixed Models Analysis|||||||0.3219
72387233|NCT03689530|144282837|SUPERIORITY|||||||0.5223|||||||Mixed Models Analysis|||||||0.5223
72387234|NCT02478632|144282853|SUPERIORITY||Mean Difference (Final Values)|1.29||||0.014|TWO_SIDED|95.0|0.27|2.31|||ANCOVA|||||2.31|0.27|0.014
72387235|NCT02478632|144282854|SUPERIORITY||Mean Difference (Final Values)|1.32||||0.039|TWO_SIDED|95.0|0.07|2.57|||ANCOVA|||||2.57|0.07|0.039
72387236|NCT02478632|144282857|SUPERIORITY||Mean Difference (Final Values)|0.09||||0.016|TWO_SIDED|95.0|0.02|0.16||p value for the difference in adjusted change from Baseline at Week 48 in total hip T-scores between the DTG+RPV and CAR groups|ANCOVA||The analysis estimated the difference between DTG+RPV and CAR in total hip T-scores|||0.16|0.02|0.016
72387237|NCT02478632|144282857|SUPERIORITY||Mean Difference (Final Values)|0.08||||0.026|TWO_SIDED|95.0|0.01|0.15||p value for the difference in adjusted change from Baseline at Week 48 in total hip Z-scores between the DTG+RPV and CAR groups|ANCOVA||The analysis estimated difference between DTG+RPV and CAR in total hip Z-score.|||0.15|0.01|0.026
72387238|NCT02478632|144282857|SUPERIORITY||Mean Difference (Final Values)|0.12||||0.049|TWO_SIDED|95.0|0.0|0.23||p value for the difference in adjusted change from Baseline at Week 48 in lumbar spine T-scores between the DTG+RPV and CAR groups|ANCOVA||The analysis estimated difference between DTG+RPV and CAR for lumbar spine T-score.|||0.23|0.00|0.049
72387239|NCT02478632|144282857|SUPERIORITY||Mean Difference (Final Values)|0.15||||0.013|TWO_SIDED|95.0|0.03|0.27||p value for the difference in adjusted change from Baseline at Week 48 in lumbar spine Z-scores between the DTG+RPV and CAR groups|ANCOVA||The analysis estimated difference between DTG+RPV and CAR in lumbar spine Z-score.|||0.27|0.03|0.013
72387240|NCT02478632|144282860|OTHER||Mean Difference (Final Values)|0.65|||||TWO_SIDED|95.0|-3.51|4.81|||||The analysis refers to INSTI and total hip.|||4.81|-3.51|
72387241|NCT02478632|144282860|OTHER||Mean Difference (Final Values)|1.6|||||TWO_SIDED|95.0|0.39|2.81|||||The analysis refers to NNRTI and total hip.|||2.81|0.39|
72387242|NCT02478632|144282860|OTHER||Mean Difference (Final Values)|1.0|||||TWO_SIDED|95.0|-1.39|3.38|||||this analysis refers to PI and total hip|||3.38|-1.39|
72387243|NCT02478632|144282860|OTHER||Mean Difference (Final Values)|3.85|||||TWO_SIDED|95.0|0.67|7.03|||||this analysis refers to INSTI and lumbar spine.|||7.03|0.67|
72387244|NCT02478632|144282860|OTHER||Mean Difference (Final Values)|1.25|||||TWO_SIDED|95.0|-0.26|2.76|||||this analysis refers to NNRTI and lumbar spine|||2.76|-0.26|
72558979|NCT01243151|144647854|SUPERIORITY_OR_OTHER||LS Mean Difference|-66.25|STANDARD_ERROR_OF_MEAN|8.112|<|0.0001|TWO_SIDED|95.0|-82.55|-49.94|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-49.94|-82.55|<0.0001
72558980|NCT01243151|144647854|SUPERIORITY_OR_OTHER||LS Mean Difference|-78.46|STANDARD_ERROR_OF_MEAN|10.766|<|0.0001|TWO_SIDED|95.0|-100.05|-56.87|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-56.87|-100.05|<0.0001
72558981|NCT01243151|144647854|SUPERIORITY_OR_OTHER||LS Mean Difference|-71.28|STANDARD_ERROR_OF_MEAN|11.051|<|0.0001|TWO_SIDED|95.0|-93.43|-49.13|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-49.13|-93.43|<0.0001
72558982|NCT01243151|144647854|SUPERIORITY_OR_OTHER||LS Mean Difference|-91.83|STANDARD_ERROR_OF_MEAN|11.018|<|0.0001|TWO_SIDED|95.0|-113.92|-69.74|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-69.74|-113.92|<0.0001
72558983|NCT01243151|144647854|SUPERIORITY_OR_OTHER||LS Mean Difference|-89.5|STANDARD_ERROR_OF_MEAN|10.736|<|0.0001|TWO_SIDED|95.0|-111.03|-67.97|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-67.97|-111.03|<0.0001
72387245|NCT02478632|144282860|OTHER||Mean Difference (Final Values)|0.38|||||TWO_SIDED|95.0|-3.0|3.77|||||this analysis refers to PI and lumbar spine|||3.77|-3.00|
72387246|NCT02478632|144282861|OTHER||Mean Difference (Final Values)|0.02|||||TWO_SIDED|95.0|-0.26|0.3|||||The analysis estimated comparison of change from baseline to Week 48 between the DTG+RPV and CAR groups in total hip T-scores by baseline third agent INSTI.|||0.30|-0.26|
72387247|NCT02478632|144282861|OTHER||Mean Difference (Final Values)|0.11|||||TWO_SIDED|95.0|0.03|0.19|||||The analysis estimated comparison of change from baseline to Week 48 between the DTG+RPV and CAR groups in total hip T-scores by baseline third agent NNRTI.|||0.19|0.03|
72387248|NCT02478632|144282861|OTHER||Mean Difference (Final Values)|0.07|||||TWO_SIDED|95.0|-0.09|0.24|||||The analysis estimated comparison of change from baseline to Week 48 between the DTG+RPV and CAR groups in total hip T-scores by baseline third agent PI.|||0.24|-0.09|
72387249|NCT02478632|144282861|OTHER||Mean Difference (Final Values)|0.06|||||TWO_SIDED|95.0|-0.25|0.37|||||The analysis estimated comparison of change from baseline to Week 48 between the DTG+RPV and CAR groups in total hip Z-scores by baseline third agent INSTI.|||0.37|-0.25|
72387250|NCT02478632|144282861|OTHER||Mean Difference (Final Values)|0.1|||||TWO_SIDED|95.0|0.02|0.18|||||The analysis estimated comparison of change from baseline to Week 48 between the DTG+RPV and CAR groups in total hip Z-scores by baseline third agent NNRTI.|||0.18|0.02|
72387251|NCT02478632|144282861|OTHER||Mean Difference (Final Values)|0.04|||||TWO_SIDED|95.0|-0.14|0.21|||||The analysis estimated comparison of change from baseline to Week 48 between the DTG+RPV and CAR groups in total hip Z-scores by baseline third agent PI.|||0.21|-0.14|
72387252|NCT02478632|144282861|OTHER||Mean Difference (Final Values)|0.36|||||TWO_SIDED|95.0|0.01|0.71|||||The analysis estimated comparison of change from baseline to Week 48 between the DTG+RPV and CAR groups in lumbar spine T-scores by baseline third agent INSTI.|||0.71|0.01|
72387253|NCT02478632|144282861|OTHER||Mean Difference (Final Values)|0.11|||||TWO_SIDED|95.0|-0.03|0.25|||||The analysis estimated comparison of change from baseline to Week 48 between the DTG+RPV and CAR groups in lumbar spine T-scores by baseline third agent NNRTI.|||0.25|-0.03|
72387254|NCT02478632|144282861|OTHER||Mean Difference (Final Values)|0.01|||||TWO_SIDED|95.0|-0.3|0.33|||||The analysis estimated comparison of change from baseline to Week 48 between the DTG+RPV and CAR groups in lumbar spine T-scores by baseline third agent PI.|||0.33|-0.30|
72387255|NCT02478632|144282861|OTHER||Mean Difference (Final Values)|0.38|||||TWO_SIDED|95.0|0.03|0.74|||||The analysis estimated comparison of change from baseline to Week 48 between the DTG+RPV and CAR groups in lumbar spine Z-scores by baseline third agent INSTI.|||0.74|0.03|
72387256|NCT02478632|144282861|OTHER||Mean Difference (Final Values)|0.12|||||TWO_SIDED|95.0|-0.02|0.26|||||The analysis estimated comparison of change from baseline to Week 48 between the DTG+RPV and CAR groups in lumbar spine Z-scores by baseline third agent NNRTI.|||0.26|-0.02|
72387257|NCT02478632|144282861|OTHER||Mean Difference (Final Values)|0.04|||||TWO_SIDED|95.0|-0.26|0.34|||||The analysis estimated comparison of change from baseline to Week 48 between the DTG+RPV and CAR groups in lumbar spine Z-scores by baseline third agent PI.|||0.34|-0.26|
72387258|NCT04622306|144282866|NON_INFERIORITY|The non-inferiority margin for the difference in total clinical failure rates (clinical breakage plus clinical slippage) between the test and control condom is specified in ISO 23409:2011 as 2.5%.|Upper 97.5% CL for difference|2.5||||0.025|ONE_SIDED|97.5||2.5||The p-value was adjusted to 0.025 since two comparisons are being made on the data set.|GEE|||Null Hypothesis: Expected test condom total clinical failure rate - expected control natural rubber latex male condom total clinical failure rate ≥ δ, where δ = 2.5%; Power calculations were conducted according to ISO 29943-1:2017. Target sample sizes were chosen to provide a power of at least 90%.||2.5||0.025
72495736|NCT03434379|144520796|SUPERIORITY||Hazard Ratio (HR)|0.49||||0.0004|TWO_SIDED|95.0|0.33|0.74|||Log Rank|||Stratified by macrovascular invasion and/or extrahepatic spread (presence vs. absence), and baseline AFP (\<400 vs. \>/= 400 ng/mL).||0.74|0.33|0.0004
72558984|NCT01243151|144647854|SUPERIORITY_OR_OTHER||LS Mean Difference|-86.73|STANDARD_ERROR_OF_MEAN|8.452|<|0.0001|TWO_SIDED|95.0|-103.73|-69.72|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-69.72|-103.73|<0.0001
72558985|NCT01243151|144647854|SUPERIORITY_OR_OTHER||LS Mean Difference|-92.18|STANDARD_ERROR_OF_MEAN|8.643|<|0.0001|TWO_SIDED|95.0|-109.57|-74.8|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-74.80|-109.57|<0.0001
72387259|NCT04622306|144282866|NON_INFERIORITY|The non-inferiority margin for the difference in total failure rates (clinical breakage plus clinical slippage) between the test and control condom is specified on ISO 23409:2011 as 2.5%|Upper 97.5% CLof difference|2.5||||0.025|ONE_SIDED|97.5||2.5||The p-value was adjusted to 0.025 since two comparisons are being made on the data set.|GEE|||Null Hypothesis: Test condom total clinical failure rate - control natural rubber latex male condom total clinical failure rate ≥ δ, where δ = 2.5%; Power calculations were conducted according to ISO 29943-1:2017. Target sample sizes were chosen to provide a power of at least 90%.||2.5||0.025
72387260|NCT04622306|144282866|NON_INFERIORITY|The non-inferiority margin for the difference in total failure rates (clinical breakage plus clinical slippage) between the test and control condom is specified on ISO 23409:2011 as 2.5%|Upper 97.5% CL for difference|2.37||||0.025|ONE_SIDED|97.5||2.5||The p-value was adjusted to 0.025 since two comparisons are being made on the data set|GEE|||The non-inferiority analysis was repeated after removing couples where the male partner had a penis length greater than 170 mm. The polyurethane condom B has a specified nominal length of 170 mm and is not recommended for men with penises longer than the length of the condom.||2.5||0.025
72387261|NCT01601132|144282903|SUPERIORITY_OR_OTHER|||||||0.5663||||||Significant difference defined a priori as p \< 0.05|Wilcoxon (Mann-Whitney)|||||||0.5663
72387262|NCT01601132|144282904|SUPERIORITY_OR_OTHER||Ratio (%) (Test/Reference)|105.86|||||TWO_SIDED|90.0|101.77|110.12|||ANOVA||Ratio (theophylline+colchicine/theophylline) of LSMs calculated using the exponentiation of the difference between treatment LSM from the log-transformed Cmax, expressed as a percentage relative to the reference treatment.|Analysis of variance (ANOVA) was performed on the log-transformed Cmax to calculate least squares mean (LSM) for each treatment. The ANOVA model included sequence, treatment, and treatment within a sequence as fixed effects, and participant as a random effect. The criterion for demonstrating a lack of a clinically significant interaction is a 90% CI for the ratio for AUC0-t, (AUC0-∞), and Cmax to be within the 0.80 to 1.25 interval, representing a maximum of 20% difference between treatments.||110.12|101.77|
72387263|NCT01601132|144282905|SUPERIORITY_OR_OTHER||Ratio (%) (Test/Reference)|105.63|||||TWO_SIDED|90.0|101.81|109.59|||ANOVA||Ratio (theophylline+colchicine/theophylline) of LSMs calculated using the exponentiation of the difference between treatment LSM from the log-transformed AUC(0-t)\], expressed as a percentage relative to the reference treatment.|Analysis of variance (ANOVA) was performed on the log-transformed AUC(0-t) to calculate least squares mean (LSM) for each treatment. The ANOVA model included sequence, treatment, and treatment within a sequence as fixed effects, and participant as a random effect. The criterion for demonstrating a lack of a clinically significant interaction is a 90% CI for the ratio for AUC0-t, AUC0-∞, and Cmax to be within the 0.80 to 1.25 interval, representing a maximum of 20% difference between treatments.||109.59|101.81|
72387264|NCT01601132|144282906|SUPERIORITY_OR_OTHER||Ratio (%) (Test/Reference)|106.43|||||TWO_SIDED|90.0|101.1|112.04|||ANOVA||Ratio (theophylline+colchicine/theophylline) of LSMs calculated using the exponentiation of the difference between treatment LSM from the log-transformed AUC(0-∞) , expressed as a percentage relative to the reference treatment.|Analysis of variance (ANOVA) was performed on the log-transformed AUC(0-∞) to calculate least squares mean (LSM) for each treatment. The ANOVA model included sequence, treatment, and treatment within a sequence as fixed effects, and participant as a random effect. The criterion for demonstrating a lack of a clinically significant interaction is a 90% CI for the ratio for AUC0-t, AUC0-∞, and Cmax to be within the 0.80 to 1.25 interval, representing a maximum of 20% difference between treatments.||112.04|101.10|
72387265|NCT01601132|144282907|SUPERIORITY_OR_OTHER||Ratio (%) (Test/Reference)|93.96|||||TWO_SIDED|90.0|89.25|98.92|||ANOVA||Ratio (theophylline+colchicine/theophylline) of LSMs calculated using the exponentiation of the difference between treatment LSM from the log-transformed CL/F, expressed as a percentage relative to the reference treatment.|Analysis of variance (ANOVA) was performed on the log-transformed CL/F to calculate least squares mean (LSM) for each treatment. The ANOVA model included sequence, treatment, and treatment within a sequence as fixed effects, and participant as a random effect. The criterion for demonstrating a lack of a clinically significant interaction is a 90% CI for the ratio for AUC0-t, AUC0-∞, and Cmax to be within the 0.80 to 1.25 interval, representing a maximum of 20% difference between treatments.||98.92|89.25|
72387266|NCT01601132|144282908|SUPERIORITY_OR_OTHER||Ratio (%) (Test/Reference)|98.59|||||TWO_SIDED|90.0|90.97|106.85|||ANOVA||Ratio (theophylline+colchicine/theophylline) of LSMs calculated using the exponentiation of the difference between treatment LSM from the log-transformed Vd/F, expressed as a percentage relative to the reference treatment.|Analysis of variance (ANOVA) was performed on the log-transformed Vd/F to calculate least squares mean (LSM) for each treatment. The ANOVA model included sequence, treatment, and treatment within a sequence as fixed effects, and participant as a random effect. The criterion for demonstrating a lack of a clinically significant interaction is a 90% CI for the ratio for AUC0-t, AUC0-∞, and Cmax to be within the 0.80 to 1.25 interval, representing a maximum of 20% difference between treatments.||106.85|90.97|
72387267|NCT00142935|144282909|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared, Corrected|||Outcome: engage in treatment post release, yes or no||||<0.001
72387268|NCT00142935|144282910|SUPERIORITY_OR_OTHER|||||||0.02|||||||Chi-squared, Corrected|||||||.02
72387269|NCT00142935|144282911|SUPERIORITY_OR_OTHER|||||||0.09||95.0|||||Chi-squared, Corrected|||||||.09
72387270|NCT00142935|144282912|SUPERIORITY_OR_OTHER|||||||0.09|||||||Chi-squared, Corrected|||||||.09
72387271|NCT00142935|144282914|SUPERIORITY_OR_OTHER|||||||0.8|||||||Chi-squared, Corrected|||||||0.8
72387272|NCT03055156|144282936|OTHER|||||||0.6|||||||t-test, 2 sided|||||||0.60
72387273|NCT03055156|144282937|OTHER|||||||0.02|||||||t-test, 2 sided|||||||0.02
72387274|NCT03055156|144282938|OTHER|||||||0.02|||||||t-test, 2 sided|||||||0.02
72387275|NCT03055156|144282939|OTHER|||||||0.01|||||||t-test, 2 sided|||||||0.01
72387276|NCT03055156|144282940|OTHER|||||||0.02|||||||t-test, 2 sided|||Analysis of Wake values||||0.02
72387277|NCT03055156|144282940|OTHER|||||||0.06|||||||t-test, 2 sided|||Analysis of REM values||||0.06
72387278|NCT03055156|144282940|OTHER|||||||0.83|||||||t-test, 2 sided|||Analysis of Non REM stage 1 values||||0.83
72387279|NCT03055156|144282940|OTHER|||||||0.87|||||||t-test, 2 sided|||Analysis of Non REM stage 2 values||||0.87
72387280|NCT03055156|144282940|OTHER|||||||0.97|||||||t-test, 2 sided|||Analysis of Non REM stage 3 values||||0.97
72387281|NCT03055156|144282941|OTHER|||||||0.38|||||||t-test, 2 sided|||||||0.38
72387282|NCT03055156|144282942|OTHER|||||||0.96|||||||t-test, 2 sided|||||||0.96
72387283|NCT03055156|144282944|OTHER|||||||0.55|||||||t-test, 2 sided|||||||0.55
72558986|NCT01243151|144647854|SUPERIORITY_OR_OTHER||LS Mean Difference|-106.06|STANDARD_ERROR_OF_MEAN|8.585|<|0.0001|TWO_SIDED|95.0|-123.34|-88.78|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-88.78|-123.34|<0.0001
72558987|NCT01243151|144647854|SUPERIORITY_OR_OTHER||LS Mean Difference|-99.18|STANDARD_ERROR_OF_MEAN|8.334|<|0.0001|TWO_SIDED|95.0|-115.95|-82.4|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-82.40|-115.95|<0.0001
72439708|NCT02528188|144393173|SUPERIORITY||Odds Ratio (OR)|1.01||||0.9046|TWO_SIDED|95.0|0.85|1.21|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 56: \>=30% reduction||1.21|0.85|0.9046
72439709|NCT02528188|144393173|SUPERIORITY||Odds Ratio (OR)|0.93||||0.4491|TWO_SIDED|95.0|0.78|1.11|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 56: \>=30% reduction||1.11|0.78|0.4491
72439710|NCT02528188|144393173|SUPERIORITY||Odds Ratio (OR)|1.03||||0.7429|TWO_SIDED|95.0|0.86|1.23|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 56: \>=50% reduction||1.23|0.86|0.7429
72439711|NCT02528188|144393173|SUPERIORITY||Odds Ratio (OR)|0.92||||0.3467|TWO_SIDED|95.0|0.77|1.1|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 56: \>=50% reduction||1.10|0.77|0.3467
72439712|NCT02528188|144393173|SUPERIORITY||Odds Ratio (OR)|1.03||||0.7624|TWO_SIDED|95.0|0.85|1.26|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 56: \>=70% reduction||1.26|0.85|0.7624
72439713|NCT02528188|144393173|SUPERIORITY||Odds Ratio (OR)|0.97||||0.7686|TWO_SIDED|95.0|0.8|1.18|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 56: \>=70% reduction||1.18|0.80|0.7686
72439714|NCT02528188|144393173|SUPERIORITY||Odds Ratio (OR)|0.99||||0.9384|TWO_SIDED|95.0|0.74|1.33|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 56: \>=90% reduction||1.33|0.74|0.9384
72439715|NCT02528188|144393173|SUPERIORITY||Odds Ratio (OR)|1.03||||0.8495|TWO_SIDED|95.0|0.77|1.38|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 56: \>=90% reduction||1.38|0.77|0.8495
72439716|NCT02528188|144393175|SUPERIORITY||Odds Ratio (OR)|1.19||||0.0651|TWO_SIDED|95.0|0.99|1.44|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 2: \>=30% reduction||1.44|0.99|0.0651
72439717|NCT02528188|144393175|SUPERIORITY||Odds Ratio (OR)|1.01||||0.9032|TWO_SIDED|95.0|0.84|1.22|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 2: \>=30% reduction||1.22|0.84|0.9032
72439718|NCT02528188|144393175|SUPERIORITY||Odds Ratio (OR)|1.36||||0.01|TWO_SIDED|95.0|1.08|1.72|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 2: \>=50% reduction||1.72|1.08|0.0100
72439719|NCT02528188|144393175|SUPERIORITY||Odds Ratio (OR)|1.12||||0.3728|TWO_SIDED|95.0|0.88|1.42|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 2: \>=50% reduction||1.42|0.88|0.3728
72439720|NCT02528188|144393175|SUPERIORITY||Odds Ratio (OR)|1.44||||0.0434|TWO_SIDED|95.0|1.01|2.04|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 2: \>=70% reduction||2.04|1.01|0.0434
72439721|NCT02528188|144393175|SUPERIORITY||Odds Ratio (OR)|1.44||||0.0425|TWO_SIDED|95.0|1.01|2.04|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 2: \>=70% reduction||2.04|1.01|0.0425
72439722|NCT02528188|144393175|SUPERIORITY||Odds Ratio (OR)|1.22||||0.5442|TWO_SIDED|95.0|0.64|2.34|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 2: \>=90% reduction||2.34|0.64|0.5442
72558988|NCT01243151|144647854|SUPERIORITY_OR_OTHER||LS Mean Difference|-79.07|STANDARD_ERROR_OF_MEAN|8.557|<|0.0001|TWO_SIDED|95.0|-96.22|-61.93|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-61.93|-96.22|<0.0001
72439723|NCT02528188|144393175|SUPERIORITY||Odds Ratio (OR)|1.9||||0.0349|TWO_SIDED|95.0|1.05|3.45|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 2: \>=90% reduction||3.45|1.05|0.0349
72439724|NCT02528188|144393175|SUPERIORITY||Odds Ratio (OR)|1.26||||0.0108|TWO_SIDED|95.0|1.05|1.51|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 4: \>=30% reduction||1.51|1.05|0.0108
72439725|NCT02528188|144393175|SUPERIORITY||Odds Ratio (OR)|1.27||||0.008|TWO_SIDED|95.0|1.07|1.52|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 4: \>=30% reduction||1.52|1.07|0.0080
72439726|NCT02528188|144393175|SUPERIORITY||Odds Ratio (OR)|1.5|||<|0.0001|TWO_SIDED|95.0|1.22|1.83|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 4: \>=50% reduction||1.83|1.22|<0.0001
72439727|NCT02528188|144393175|SUPERIORITY||Odds Ratio (OR)|1.51|||<|0.0001|TWO_SIDED|95.0|1.24|1.85|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 4: \>=50% reduction||1.85|1.24|<0.0001
72439728|NCT02528188|144393175|SUPERIORITY||Odds Ratio (OR)|1.45||||0.006|TWO_SIDED|95.0|1.11|1.88|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 4: \>=70% reduction||1.88|1.11|0.0060
72439729|NCT02528188|144393175|SUPERIORITY||Odds Ratio (OR)|1.49||||0.0031|TWO_SIDED|95.0|1.14|1.93|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 4: \>=70% reduction||1.93|1.14|0.0031
72439730|NCT02528188|144393175|SUPERIORITY||Odds Ratio (OR)|1.76||||0.0235|TWO_SIDED|95.0|1.08|2.88|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 4: \>=90% reduction||2.88|1.08|0.0235
72439731|NCT02528188|144393175|SUPERIORITY||Odds Ratio (OR)|2.12||||0.0021|TWO_SIDED|95.0|1.31|3.42|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 4: \>=90% reduction||3.42|1.31|0.0021
72439732|NCT02528188|144393175|SUPERIORITY||Odds Ratio (OR)|1.03||||0.7613|TWO_SIDED|95.0|0.86|1.23|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 8: \>=30% reduction||1.23|0.86|0.7613
72439733|NCT02528188|144393175|SUPERIORITY||Odds Ratio (OR)|1.19||||0.0548|TWO_SIDED|95.0|1.0|1.43|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 8: \>=30% reduction||1.43|1.00|0.0548
72439734|NCT02528188|144393175|SUPERIORITY||Odds Ratio (OR)|1.25||||0.0196|TWO_SIDED|95.0|1.04|1.51|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 8: \>=50% reduction||1.51|1.04|0.0196
72439735|NCT02528188|144393175|SUPERIORITY||Odds Ratio (OR)|1.45|||<|0.0001|TWO_SIDED|95.0|1.2|1.75|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 8: \>=50% reduction||1.75|1.20|<0.0001
72439736|NCT02528188|144393175|SUPERIORITY||Odds Ratio (OR)|1.39||||0.0077||95.0|1.09|1.77|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 8: \>=70% reduction||1.77|1.09|0.0077
72439737|NCT02528188|144393175|SUPERIORITY||Odds Ratio (OR)|1.65|||<|0.0001|TWO_SIDED|95.0|1.3|2.09|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 8: \>=70% reduction||2.09|1.30|<0.0001
72439738|NCT02528188|144393175|SUPERIORITY||Odds Ratio (OR)|1.31||||0.1942|TWO_SIDED|95.0|0.87|1.96|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 8: \>=90% reduction||1.96|0.87|0.1942
72439739|NCT02528188|144393175|SUPERIORITY||Odds Ratio (OR)|1.64||||0.0122|TWO_SIDED|95.0|1.11|2.43|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 8: \>=90% reduction||2.43|1.11|0.0122
72439740|NCT02528188|144393175|SUPERIORITY||Odds Ratio (OR)|1.18||||0.0977|TWO_SIDED|95.0|0.97|1.43|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 16: \>=30% reduction||1.43|0.97|0.0977
72439741|NCT02528188|144393175|SUPERIORITY||Odds Ratio (OR)|1.19||||0.0806|TWO_SIDED|95.0|0.98|1.44|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 16: \>=30% reduction||1.44|0.98|0.0806
72439742|NCT02528188|144393175|SUPERIORITY||Odds Ratio (OR)|1.12||||0.2097|TWO_SIDED|95.0|0.94|1.34|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 16: \>=50% reduction||1.34|0.94|0.2097
72439743|NCT02528188|144393175|SUPERIORITY||Odds Ratio (OR)|1.25||||0.0135|TWO_SIDED|95.0|1.05|1.49|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 16: \>=50% reduction||1.49|1.05|0.0135
72439744|NCT02528188|144393175|SUPERIORITY||Odds Ratio (OR)|1.1||||0.3571|TWO_SIDED|95.0|0.9|1.33|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 16: \>=70% reduction||1.33|0.90|0.3571
72558989|NCT01243151|144647854|SUPERIORITY_OR_OTHER||LS Mean Difference|-83.89|STANDARD_ERROR_OF_MEAN|8.736|<|0.0001|TWO_SIDED|95.0|-101.4|-66.39|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-66.39|-101.40|<0.0001
72558990|NCT01243151|144647854|SUPERIORITY_OR_OTHER||LS Mean Difference|-104.74|STANDARD_ERROR_OF_MEAN|8.679|<|0.0001|TWO_SIDED|95.0|-122.13|-87.35|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-87.35|-122.13|<0.0001
72387284|NCT03055156|144282945|OTHER|||||||0.86|||||||t-test, 2 sided|||analysis of 0-90 minutes||||0.86
72387285|NCT03055156|144282945|OTHER|||||||0.29|||||||t-test, 2 sided|||analysis of 90-180 minutes||||0.29
72387286|NCT03055156|144282945|OTHER|||||||0.58|||||||t-test, 2 sided|||analysis of 180-270 minutes||||0.58
72387287|NCT03055156|144282945|OTHER|||||||0.62|||||||t-test, 2 sided|||analysis of 270-360 min||||0.62
72387288|NCT03055156|144282946|OTHER|||||||0.389|||||||ANOVA|||Implemented two-way mixed ANOVA with time as within-subject variable and topper type as between-subject variable. This is to compare the difference in core body temperature trend over time between the two study arms. Interaction between time and topper type on CBT was calculated.||||0.389
72387289|NCT03055156|144282946|OTHER|||||||0.01|||||||ANOVA|||Implemented two-way mixed ANOVA with time as within-subject variable and topper type as between-subject variable. This is to see the effect over time from both study arms on CBT. Main effect of time on CBT.||||0.01
72387290|NCT03055156|144282946|OTHER|||||||0.642|||||||ANOVA|||Implemented two-way mixed ANOVA with time as within-subject variable and topper type as between-subject variable. This is to see the effect of the intervention on CBT including all time points. Main effect of topper type on CBT.||||0.642
72439745|NCT02528188|144393175|SUPERIORITY||Odds Ratio (OR)|1.34||||0.0025|TWO_SIDED|95.0|1.11|1.63|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 16: \>=70% reduction||1.63|1.11|0.0025
72495737|NCT03434379|144520797|SUPERIORITY||Hazard Ratio (HR)|0.45||||0.0035|TWO_SIDED|95.0|0.26|0.78|||Log Rank|||Physical Functioning: Stratified by macrovascular invasion and/or extrahepatic spread (presence vs. absence), and baseline AFP (\<400 vs. \>/= 400 ng/mL).||0.78|0.26|0.0035
72387291|NCT03055156|144282947|OTHER|||||||0.61|||||||t-test, 2 sided|||||||0.61
72387292|NCT03055156|144282948|OTHER|||||||0.71|||||||t-test, 2 sided|||||||0.71
72387293|NCT03055156|144282949|OTHER|||||||1|||||||t-test, 2 sided|||||||1.00
72387294|NCT02130570|144282964|SUPERIORITY||Incidence rate ratio|0.52||||0.02|TWO_SIDED|95.0|0.3|0.91||This is the P-value for the adjusted IRR.|Regression poissant|"Please see the Other Statistical Analysis field for adjustments."|||Adjusted for study month, Elixhauser comorbidity score, patient age, sex, language, race/ethnicity, cognitive status, health literacy, functional status one month prior to admission, caregiver status, median income by zip code, ED visits in the previous 6 months, HOSPITAL readmission risk score, inpatient unit, and primary care practice. IRR: incidence rate ratio|0.91|0.30|0.02
72439746|NCT02528188|144393175|SUPERIORITY||Odds Ratio (OR)|1.11||||0.4658|TWO_SIDED|95.0|0.83|1.49|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 16: \>=90% reduction||1.49|0.83|0.4658
72439747|NCT02528188|144393175|SUPERIORITY||Odds Ratio (OR)|1.44||||0.0108|TWO_SIDED|95.0|1.09|1.9|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 16: \>=90% reduction||1.90|1.09|0.0108
72495738|NCT03434379|144520797|SUPERIORITY||Hazard Ratio (HR)|0.71||||0.2214|TWO_SIDED|95.0|0.42|1.23|||Log Rank|||Role Functioning: Stratified by macrovascular invasion and/or extrahepatic spread (presence vs. absence), and baseline AFP (\<400 vs. \>/= 400 ng/mL).||1.23|0.42|0.2214
72495739|NCT03434379|144520797|SUPERIORITY||Hazard Ratio (HR)|0.53||||0.0135|TWO_SIDED|95.0|0.32|0.88|||Log Rank|||GHS/QoL: Stratified by macrovascular invasion and/or extrahepatic spread (presence vs. absence), and baseline AFP (\<400 vs. \>/= 400 ng/mL).||0.88|0.32|0.0135
72558991|NCT01243151|144647854|SUPERIORITY_OR_OTHER||LS Mean Difference|-97.0|STANDARD_ERROR_OF_MEAN|8.426|<|0.0001|TWO_SIDED|95.0|-113.89|-80.11|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-80.11|-113.89|<0.0001
72439748|NCT02528188|144393175|SUPERIORITY||Odds Ratio (OR)|1.02||||0.8393|TWO_SIDED|95.0|0.85|1.22|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 24: \>=30% reduction||1.22|0.85|0.8393
72439749|NCT02528188|144393175|SUPERIORITY||Odds Ratio (OR)|1.1||||0.2977|TWO_SIDED|95.0|0.92|1.32|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 24: \>=30% reduction||1.32|0.92|0.2977
72439750|NCT02528188|144393175|SUPERIORITY||Odds Ratio (OR)|1.12||||0.1944|TWO_SIDED|95.0|0.94|1.34|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 24: \>=50% reduction||1.34|0.94|0.1944
72439751|NCT02528188|144393175|SUPERIORITY||Odds Ratio (OR)|1.05||||0.5714|TWO_SIDED|95.0|0.88|1.26|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 24: \>=50% reduction||1.26|0.88|0.5714
72439752|NCT02528188|144393175|SUPERIORITY||Odds Ratio (OR)|1.12||||0.2472|TWO_SIDED|95.0|0.92|1.36|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 24: \>=70% reduction||1.36|0.92|0.2472
72439753|NCT02528188|144393175|SUPERIORITY||Odds Ratio (OR)|1.25||||0.0235|TWO_SIDED|95.0|1.03|1.51|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 24: \>=70% reduction||1.51|1.03|0.0235
72439754|NCT02528188|144393175|SUPERIORITY||Odds Ratio (OR)|1.13||||0.4074|TWO_SIDED|95.0|0.85|1.51|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 24: \>=90% reduction||1.51|0.85|0.4074
72439755|NCT02528188|144393175|SUPERIORITY||Odds Ratio (OR)|1.37||||0.0296|TWO_SIDED|95.0|1.03|1.81|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 24: \>=90% reduction||1.81|1.03|0.0296
72439756|NCT02528188|144393175|SUPERIORITY||Odds Ratio (OR)|1.03||||0.7607|TWO_SIDED|95.0|0.86|1.23|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 32: \>=30% reduction||1.23|0.86|0.7607
72439757|NCT02528188|144393175|SUPERIORITY||Odds Ratio (OR)|1.02||||0.7979|TWO_SIDED|95.0|0.86|1.22|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 32: \>=30% reduction||1.22|0.86|0.7979
72439758|NCT02528188|144393175|SUPERIORITY||Odds Ratio (OR)|1.1||||0.2964|TWO_SIDED|95.0|0.92|1.31|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 32: \>=50% reduction||1.31|0.92|0.2964
72439759|NCT02528188|144393175|SUPERIORITY||Odds Ratio (OR)|1.04||||0.695|TWO_SIDED|95.0|0.87|1.24|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 32: \>=50% reduction||1.24|0.87|0.6950
72439760|NCT02528188|144393175|SUPERIORITY||Odds Ratio (OR)|1.14||||0.1985|TWO_SIDED|95.0|0.93|1.38|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 32: \>=70% reduction||1.38|0.93|0.1985
72439761|NCT02528188|144393175|SUPERIORITY||Odds Ratio (OR)|1.17||||0.1239|TWO_SIDED|95.0|0.96|1.42|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 32: \>=70% reduction||1.42|0.96|0.1239
72439762|NCT02528188|144393175|SUPERIORITY||Odds Ratio (OR)|1.18||||0.2762|TWO_SIDED|95.0|0.88|1.58|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 32: \>=90% reduction||1.58|0.88|0.2762
72439763|NCT02528188|144393175|SUPERIORITY||Odds Ratio (OR)|1.44||||0.0121|TWO_SIDED|95.0|1.08|1.91|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 32: \>=90% reduction||1.91|1.08|0.0121
72495740|NCT02363478|144520835|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|This statistical analysis applies to changes of amplitude of contractions, resting LES pressure and IRP between baseline and week 4.||||||<0.05
72558992|NCT01243151|144647855|SUPERIORITY_OR_OTHER||LS Mean Difference|-22.3|STANDARD_ERROR_OF_MEAN|29.336||0.448|TWO_SIDED|95.0|-80.08|35.49|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||35.49|-80.08|0.4480
72439764|NCT02528188|144393175|SUPERIORITY||Odds Ratio (OR)|1.02||||0.8443|TWO_SIDED|95.0|0.85|1.22|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 40: \>=30% reduction||1.22|0.85|0.8443
72439765|NCT02528188|144393175|SUPERIORITY||Odds Ratio (OR)|1.02||||0.8472|TWO_SIDED|95.0|0.85|1.22|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 40: \>=30% reduction||1.22|0.85|0.8472
72439766|NCT02528188|144393175|SUPERIORITY||Odds Ratio (OR)|1.01||||0.898|TWO_SIDED|95.0|0.85|1.21|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 40: \>=50% reduction||1.21|0.85|0.8980
72439767|NCT02528188|144393175|SUPERIORITY||Odds Ratio (OR)|0.99||||0.9385|TWO_SIDED|95.0|0.83|1.19|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 40: \>=50% reduction||1.19|0.83|0.9385
72439768|NCT02528188|144393175|SUPERIORITY||Odds Ratio (OR)|1.08||||0.4261|TWO_SIDED|95.0|0.89|1.32|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 40: \>=70% reduction||1.32|0.89|0.4261
72439769|NCT02528188|144393175|SUPERIORITY||Odds Ratio (OR)|1.07||||0.525|TWO_SIDED|95.0|0.88|1.3|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 40: \>=70% reduction||1.30|0.88|0.5250
72439770|NCT02528188|144393175|SUPERIORITY||Odds Ratio (OR)|1.08||||0.6273|TWO_SIDED|95.0|0.8|1.45|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 40: \>=90% reduction||1.45|0.80|0.6273
72439771|NCT02528188|144393175|SUPERIORITY||Odds Ratio (OR)|1.43||||0.0132|TWO_SIDED|95.0|1.08|1.9|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 40: \>=90% reduction||1.90|1.08|0.0132
72439772|NCT02528188|144393175|SUPERIORITY||Odds Ratio (OR)|0.99||||0.9095|TWO_SIDED|95.0|0.83|1.18|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 48: \>=30% reduction||1.18|0.83|0.9095
72439773|NCT02528188|144393175|SUPERIORITY||Odds Ratio (OR)|0.94||||0.5098|TWO_SIDED|95.0|0.79|1.12|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 48: \>=30% reduction||1.12|0.79|0.5098
72439774|NCT02528188|144393175|SUPERIORITY||Odds Ratio (OR)|1.07||||0.4488|TWO_SIDED|95.0|0.9|1.28|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 48: \>=50% reduction||1.28|0.90|0.4488
72439775|NCT02528188|144393175|SUPERIORITY||Odds Ratio (OR)|1.0||||0.9757|TWO_SIDED|95.0|0.83|1.19|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 48: \>=50% reduction||1.19|0.83|0.9757
72439776|NCT02528188|144393175|SUPERIORITY||Odds Ratio (OR)|1.14||||0.1843|TWO_SIDED|95.0|0.94|1.39|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 48: \>=70% reduction||1.39|0.94|0.1843
72439777|NCT02528188|144393175|SUPERIORITY||Odds Ratio (OR)|1.08||||0.4356|TWO_SIDED|95.0|0.89|1.32|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 48: \>=70% reduction||1.32|0.89|0.4356
72439778|NCT02528188|144393175|SUPERIORITY||Odds Ratio (OR)|1.08||||0.6342|TWO_SIDED|95.0|0.8|1.45|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 48: \>=90% reduction||1.45|0.80|0.6342
72439779|NCT02528188|144393175|SUPERIORITY||Odds Ratio (OR)|1.29||||0.081|TWO_SIDED|95.0|0.97|1.73|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 48: \>=90% reduction||1.73|0.97|0.0810
72495741|NCT02363478|144520838|SUPERIORITY_OR_OTHER|||||||0.05|||||||t-test, 2 sided|This statistical analysis applies to changes of amplitude of heartburn, regurgitation, chest pain and dysphagia between baseline and week 4.||||||0.05
72495742|NCT03160560|144520844|SUPERIORITY||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||Baseline, Week 1, Week 2, Week 3||||<0.010
72558993|NCT01243151|144647855|SUPERIORITY_OR_OTHER||LS Mean Difference|-32.52|STANDARD_ERROR_OF_MEAN|30.091||0.2809|TWO_SIDED|95.0|-91.8|26.76|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||26.76|-91.80|0.2809
72558994|NCT01243151|144647855|SUPERIORITY_OR_OTHER||LS Mean Difference|-31.92|STANDARD_ERROR_OF_MEAN|29.942||0.2875|TWO_SIDED|95.0|-90.9|27.07|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||27.07|-90.90|0.2875
72558995|NCT01243151|144647855|SUPERIORITY_OR_OTHER||LS Mean Difference|-16.52|STANDARD_ERROR_OF_MEAN|29.37||0.5743|TWO_SIDED|95.0|-74.38|41.33|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||41.33|-74.38|0.5743
72558996|NCT01243151|144647855|SUPERIORITY_OR_OTHER||LS Mean Difference|-19.83|STANDARD_ERROR_OF_MEAN|29.336||0.4997|TWO_SIDED|95.0|-77.62|37.96|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||37.96|-77.62|0.4997
72558997|NCT01243151|144647855|SUPERIORITY_OR_OTHER||LS Mean Difference|-21.5|STANDARD_ERROR_OF_MEAN|30.091||0.4756|TWO_SIDED|95.0|-80.78|37.78|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||37.78|-80.78|0.4756
72558998|NCT01243151|144647855|SUPERIORITY_OR_OTHER||LS Mean Difference|-17.73|STANDARD_ERROR_OF_MEAN|30.458||0.561|TWO_SIDED|95.0|-77.73|42.26|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||42.26|-77.73|0.5610
72558999|NCT01243151|144647855|SUPERIORITY_OR_OTHER||LS Mean Difference|-21.41|STANDARD_ERROR_OF_MEAN|29.37||0.4667|TWO_SIDED|95.0|-79.27|36.44|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||36.44|-79.27|0.4667
72559000|NCT01243151|144647855|SUPERIORITY_OR_OTHER||LS Mean Difference|-30.7|STANDARD_ERROR_OF_MEAN|29.828||0.3045|TWO_SIDED|95.0|-89.45|28.06|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||28.06|-89.45|0.3045
72439780|NCT02528188|144393175|SUPERIORITY||Odds Ratio (OR)|0.96||||0.6527|TWO_SIDED|95.0|0.8|1.15|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 56: \>=30% reduction||1.15|0.80|0.6527
72439781|NCT02528188|144393175|SUPERIORITY||Odds Ratio (OR)|0.92||||0.3857|TWO_SIDED|95.0|0.77|1.1|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 56: \>=30% reduction||1.10|0.77|0.3857
72439782|NCT02528188|144393175|SUPERIORITY||Odds Ratio, log|1.06||||0.528|TWO_SIDED|95.0|0.89|1.27|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 56: \>=50% reduction||1.27|0.89|0.5280
72559001|NCT01243151|144647855|SUPERIORITY_OR_OTHER||LS Mean Difference|-23.78|STANDARD_ERROR_OF_MEAN|30.091||0.4301|TWO_SIDED|95.0|-83.06|35.5|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||35.50|-83.06|0.4301
72559002|NCT01243151|144647855|SUPERIORITY_OR_OTHER||LS Mean Difference|-52.15|STANDARD_ERROR_OF_MEAN|30.458||0.0881|TWO_SIDED|95.0|-112.15|7.85|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||7.85|-112.15|0.0881
72495743|NCT03160560|144520844|SUPERIORITY|||||||0.932|||||||Wilcoxon (Mann-Whitney)|||Baseline, Week 1, Week 2, Week 3||||.932
72559003|NCT01243151|144647855|SUPERIORITY_OR_OTHER||LS Mean Difference|-31.51|STANDARD_ERROR_OF_MEAN|29.37||0.2844|TWO_SIDED|95.0|-89.36|26.35|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||26.35|-89.36|0.2844
72559004|NCT01243151|144647855|SUPERIORITY_OR_OTHER||LS Mean Difference|-26.56|STANDARD_ERROR_OF_MEAN|29.828||0.3741|TWO_SIDED|95.0|-85.32|32.19|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||32.19|-85.32|0.3741
72559005|NCT01243151|144647855|SUPERIORITY_OR_OTHER||LS Mean Difference|-23.88|STANDARD_ERROR_OF_MEAN|30.091||0.4283|TWO_SIDED|95.0|-83.16|35.4|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||35.40|-83.16|0.4283
72559006|NCT01243151|144647855|SUPERIORITY_OR_OTHER||LS Mean Difference|-56.32|STANDARD_ERROR_OF_MEAN|30.458||0.0657|TWO_SIDED|95.0|-116.31|3.68|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||3.68|-116.31|0.0657
72559007|NCT01243151|144647855|SUPERIORITY_OR_OTHER||LS Mean Difference|-33.26|STANDARD_ERROR_OF_MEAN|29.37||0.2586|TWO_SIDED|95.0|-91.11|24.6|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||24.60|-91.11|0.2586
72559008|NCT01243151|144647856|SUPERIORITY_OR_OTHER||LS Mean Difference|3.33|STANDARD_ERROR_OF_MEAN|3.404||0.3326|TWO_SIDED|95.0|-3.49|10.14|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||10.14|-3.49|0.3326
72387295|NCT02130570|144282965|SUPERIORITY||Incidence rate ratio|0.78||||0.01|TWO_SIDED|95.0|0.64|0.95||This is the p-value for the adjusted rate|Regression poissant|"For adjustments, please see the Other Statistical Analysis field below."|||Adjusted for study month, Elixhauser comorbidity score, patient age, sex, language, race/ethnicity, cognitive status, health literacy, functional status one month prior to admission, caregiver status, median income by zip code, ED visits in the previous 6 months, HOSPITAL readmission risk score, inpatient unit, and primary care practice. IRR: incidence rate ratio|0.95|0.64|0.01
72387296|NCT02130570|144282966|SUPERIORITY||Odds Ratio (OR)|1.08||||0.77|TWO_SIDED|95.0|0.64|1.85||This is the P-value for the adjusted Odds Ratio|Regression, Logistic|"For adjustments, please see the Other Statistical Analysis field below."|||Adjusted for study month, Elixhauser comorbidity score, patient age, sex, language, race/ethnicity, cognitive status, health literacy, functional status one month prior to admission, caregiver status, median income by zip code, ED visits in the previous 6 months, HOSPITAL readmission risk score; clustered by inpatient unit; primary care practice as a random effect . OR: odds ratio|1.85|0.64|0.77
72387297|NCT02130570|144282967|SUPERIORITY||Mean Difference (Final Values)|0.08||||0.91|TWO_SIDED|||||This is the P-value for the adjusted difference.|Regression, Linear|"Please see the Other Statistical Analysis field for adjustments."|||Adjusted for study month, Elixhauser comorbidity score, patient age, sex, language, race/ethnicity, cognitive status, health literacy, functional status one month prior to admission, caregiver status, median income by zip code, ED visits in the previous 6 months, HOSPITAL readmission risk score; clustered by inpatient unit; primary care practice as a random effect.|||0.91
72387298|NCT02130570|144282968|SUPERIORITY||Odds Ratio, log|0.85||||0.57|TWO_SIDED|95.0|0.47|1.51||"Please see the Other Statistical Analysis field for adjustments and the P-value computed for each survey question."|Regression, Logistic||"Please see the Other Statistical Analysis field for a list of the estimated value and 95% CI for each survey question."||"Please see the Other Statistical Analysis field for adjustments."|1.51|0.47|0.57
72387299|NCT05981391|144282977|SUPERIORITY|||||||0.01||||||Adjusted for multiple comparisons.|t-test, 2 sided|||||||0.01
72387300|NCT03993132|144282979|OTHER|A Cox regression with selected variables based on previous literature, covariate data availability, examination of exposure group differences in the distribution of each covariate, and the association of covariates with the outcomes of interest was applied. The hazard ratio compare Empagliflozin versus Liraglutide (reference).|Hazard Ratio (HR)|1.01|||||TWO_SIDED|95.0|0.91|1.11|||||Hazard ratio compares empagliflozin versus liraglutide (reference).|||1.11|0.91|
72387301|NCT03993132|144282980|OTHER|A Cox regression with selected variables based on previous literature, covariate data availability, examination of exposure group differences in the distribution of each covariate, and the association of covariates with the outcomes of interest was applied. The hazard ratio compare Empagliflozin versus Liraglutide (reference).|Hazard Ratio (HR)|1.07|||||TWO_SIDED|95.0|1.01|1.13|||||Hazard ratio compares empagliflozin versus liraglutide (reference).|||1.13|1.01|
72387302|NCT03993132|144282981|OTHER|A Cox regression with selected variables based on previous literature, covariate data availability, examination of exposure group differences in the distribution of each covariate, and the association of covariates with the outcomes of interest was applied. The hazard ratio compare Empagliflozin versus Liraglutide (reference).|Hazard Ratio (HR)|0.95|||||TWO_SIDED|95.0|0.84|1.08|||||Hazard ratio compares empagliflozin versus liraglutide (reference).|||1.08|0.84|
72387303|NCT03993132|144282982|OTHER|A Cox regression with selected variables based on previous literature, covariate data availability, examination of exposure group differences in the distribution of each covariate, and the association of covariates with the outcomes of interest was applied. The hazard ratio compare Empagliflozin versus Liraglutide (reference).|Hazard Ratio (HR)|1.03|||||TWO_SIDED|95.0|0.96|1.11|||||Hazard ratio compares empagliflozin versus liraglutide (reference).|||1.11|0.96|
72387304|NCT03993132|144282983|OTHER|A Cox regression with selected variables based on previous literature, covariate data availability, examination of exposure group differences in the distribution of each covariate, and the association of covariates with the outcomes of interest was applied. The hazard ratio compare Empagliflozin versus Liraglutide (reference).|Hazard Ratio (HR)|0.71|||||TWO_SIDED|95.0|0.61|0.83|||||Hazard ratio compares empagliflozin versus liraglutide (reference).|||0.83|0.61|
72387305|NCT03993132|144282984|OTHER|A Cox regression with selected variables based on previous literature, covariate data availability, examination of exposure group differences in the distribution of each covariate, and the association of covariates with the outcomes of interest was applied. The hazard ratio compare Empagliflozin versus Liraglutide (reference).|Hazard Ratio (HR)|0.83|||||TWO_SIDED|95.0|0.76|0.91|||||Hazard ratio compares empagliflozin versus liraglutide (reference).|||0.91|0.76|
72387306|NCT03993132|144282985|OTHER|A Cox regression with selected variables based on previous literature, covariate data availability, examination of exposure group differences in the distribution of each covariate, and the association of covariates with the outcomes of interest was applied. The hazard ratio compare Empagliflozin versus Liraglutide (reference).|Hazard Ratio (HR)|0.92|||||TWO_SIDED|95.0|0.88|0.96|||||Hazard ratio compares empagliflozin versus liraglutide (reference).|||0.96|0.88|
72387307|NCT03993132|144282986|OTHER|A Cox regression with selected variables based on previous literature, covariate data availability, examination of exposure group differences in the distribution of each covariate, and the association of covariates with the outcomes of interest was applied. The hazard ratio compare Empagliflozin versus Liraglutide (reference).|Hazard Ratio (HR)|0.94|||||TWO_SIDED|95.0|0.91|0.96|||||Hazard ratio compares empagliflozin versus liraglutide (reference).|||0.96|0.91|
72387308|NCT03993132|144282987|OTHER|A Cox regression with selected variables based on previous literature, covariate data availability, examination of exposure group differences in the distribution of each covariate, and the association of covariates with the outcomes of interest was applied. The hazard ratio compare Empagliflozin versus Liraglutide (reference).|Hazard Ratio (HR)|0.92|||||TWO_SIDED|95.0|0.88|0.96|||||Hazard ratio compares empagliflozin versus liraglutide (reference).|||0.96|0.88|
72495744|NCT03160560|144520844|SUPERIORITY|||||||0.853|||||||Wilcoxon (Mann-Whitney)|||Baseline 2, Week 6, Week 7, Week 8||||.853
72495745|NCT03160560|144520844|SUPERIORITY|||||||0.032|||||||Wilcoxon (Mann-Whitney)|||Baseline-2, Week 6, Week 7, Week 8||||.032
72495746|NCT03160560|144520844|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Baseline, Week 1, Week 2, Week 3||||<0.001
72495747|NCT03160560|144520844|SUPERIORITY|||||||0.75|||||||Wilcoxon (Mann-Whitney)|||Baseline, Week 1, Week 2, Week 3||||.750
72495748|NCT03160560|144520844|SUPERIORITY|||||||0.81|||||||Wilcoxon (Mann-Whitney)|||Baseline 2, Week 6, Week 7, Week 8||||.810
72559009|NCT01243151|144647856|SUPERIORITY_OR_OTHER||LS Mean Difference|3.69|STANDARD_ERROR_OF_MEAN|3.502||0.2967|TWO_SIDED|95.0|-3.32|10.7|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||10.70|-3.32|0.2967
72387309|NCT03993132|144282988|OTHER|A Cox regression with selected variables based on previous literature, covariate data availability, examination of exposure group differences in the distribution of each covariate, and the association of covariates with the outcomes of interest was applied. The hazard ratio compare Empagliflozin versus Liraglutide (reference).|Hazard Ratio (HR)|0.93|||||TWO_SIDED|95.0|0.91|0.96|||||Hazard ratio compares empagliflozin versus liraglutide (reference).|||0.96|0.91|
72387310|NCT03993132|144282989|OTHER|A Cox regression with selected variables based on previous literature, covariate data availability, examination of exposure group differences in the distribution of each covariate, and the association of covariates with the outcomes of interest was applied. The hazard ratio compare Empagliflozin versus Liraglutide (reference).|Hazard Ratio (HR)|0.99|||||TWO_SIDED|95.0|0.83|1.18|||||Hazard ratio compares empagliflozin versus liraglutide (reference).|||1.18|0.83|
72387311|NCT03993132|144282990|OTHER|A Cox regression with selected variables based on previous literature, covariate data availability, examination of exposure group differences in the distribution of each covariate, and the association of covariates with the outcomes of interest was applied. The hazard ratio compare Empagliflozin versus Liraglutide (reference).|Hazard Ratio (HR)|1.06|||||TWO_SIDED|95.0|0.97|1.16|||||Hazard ratio compares empagliflozin versus liraglutide (reference).|||1.16|0.97|
72495749|NCT03160560|144520844|SUPERIORITY|||||||0.006|||||||Wilcoxon (Mann-Whitney)|||Baseline 2, Week 6, Week 7, Week 8||||.006
72495750|NCT01641939|144520883|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.15||||0.8589|TWO_SIDED|95.0|0.87|1.6||One sided p-value with correction for interim treatment selection due to adaptive seamless phase design.|Log Rank|Log-Rank test, inverse normal combination test.||The unstratified Cox proportional hazards model was used to estimate the hazard ratio. The 95% Confidence Interval (CI) for median was computed using the method of Brookmeyer and Crowley. Reference group: Standard Taxane Therapy.||1.60|0.87|0.8589
72439783|NCT02528188|144393175|SUPERIORITY||Odds Ratio (OR)|0.94||||0.5355|TWO_SIDED|95.0|0.79|1.13|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 56: \>=50% reduction||1.13|0.79|0.5355
72439784|NCT02528188|144393175|SUPERIORITY||Odds Ratio (OR)|1.03||||0.7732|TWO_SIDED|95.0|0.84|1.26|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 56: \>=70% reduction||1.26|0.84|0.7732
72439785|NCT02528188|144393175|SUPERIORITY||Odds Ratio (OR)|1.01||||0.9397|TWO_SIDED|95.0|0.82|1.23|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 56: \>=70% reduction||1.23|0.82|0.9397
72439786|NCT02528188|144393175|SUPERIORITY||Odds Ratio (OR)|1.02||||0.9044|TWO_SIDED|95.0|0.75|1.39|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 56: \>=90% reduction||1.39|0.75|0.9044
72495751|NCT01641939|144520884|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.81|||||TWO_SIDED|95.0|0.32|2.03||||||The unstratified Cox proportional hazards model was used to estimate the hazard ratio. The 95% CI for median was computed using the method of Brookmeyer and Crowley. Reference group: Standard Taxane Therapy.||2.03|0.32|
72495752|NCT01641939|144520884|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.01|||||TWO_SIDED|95.0|0.82|4.92||||||The unstratified Cox proportional hazards model was used to estimate the hazard ratio. The 95% CI for median was computed using the method of Brookmeyer and Crowley. Reference group: Standard Taxane Therapy.||4.92|0.82|
72495753|NCT01641939|144520884|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.47|||||TWO_SIDED|95.0|0.23|0.96||||||The unstratified Cox proportional hazards model was used to estimate the hazard ratio. The 95% CI for median was computed using the method of Brookmeyer and Crowley. Reference group: Trastuzumab Emtansine 3.6 mg||0.96|0.23|
72495754|NCT01641939|144520886|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.13||||0.308|TWO_SIDED|95.0|0.89|1.43|||Log Rank|||The unstratified Cox proportional hazards model was used to estimate the hazard ratio. The 95% CI for median was computed using the method of Brookmeyer and Crowley. Reference group: Standard Taxane Therapy||1.43|0.89|0.308
72495755|NCT01815229|144520901|OTHER||||||<|0.05||||||P value applies to cell count at removal|t-test, 2 sided|||Tracheal lavages (TL) were done in intubated humans to obtain cell counts.||||<0.05
72495756|NCT00168831|144520939|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.113|STANDARD_ERROR_OF_MEAN|0.017|<|0.0001||95.0|||||ANCOVA|ANCOVA analysis with terms for treatment, smoking status at entry, centre and baseline value|Tiotropium Respimat 5mcg - Placebo|||||<0.0001
72495757|NCT00168831|144520939|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.14|STANDARD_ERROR_OF_MEAN|0.017|<|0.0001||95.0|||||ANCOVA|ANCOVA analysis with terms for treatment, smoking status at entry,centre and baseline value|Tiotropium Respimat 10mcg - Placebo|||||<0.0001
72495758|NCT00168831|144520940|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.713|STANDARD_ERROR_OF_MEAN|1.052||0.0004||95.0|||||ANCOVA|The means are adjusted for centre, smoking status at entry and baseline value.|Tiotropium Respimat 5mcg - Placebo|||||0.0004
72559010|NCT01243151|144647856|SUPERIORITY_OR_OTHER||LS Mean Difference|0.52|STANDARD_ERROR_OF_MEAN|3.466||0.8812|TWO_SIDED|95.0|-6.42|7.46|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||7.46|-6.42|0.8812
72559011|NCT01243151|144647856|SUPERIORITY_OR_OTHER||LS Mean Difference|3.42|STANDARD_ERROR_OF_MEAN|3.433||0.3227|TWO_SIDED|95.0|-3.45|10.3|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||10.30|-3.45|0.3227
72559012|NCT01243151|144647856|SUPERIORITY_OR_OTHER||LS Mean Difference|10.01|STANDARD_ERROR_OF_MEAN|4.221||0.021|TWO_SIDED|95.0|1.56|18.46|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||18.46|1.56|0.0210
72559013|NCT01243151|144647856|SUPERIORITY_OR_OTHER||LS Mean Difference|6.84|STANDARD_ERROR_OF_MEAN|4.326||0.1192|TWO_SIDED|95.0|-1.82|15.49|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||15.49|-1.82|0.1192
72559014|NCT01243151|144647856|SUPERIORITY_OR_OTHER||LS Mean Difference|5.04|STANDARD_ERROR_OF_MEAN|4.367||0.2529|TWO_SIDED|95.0|-3.69|13.78|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||13.78|-3.69|0.2529
72559015|NCT01243151|144647856|SUPERIORITY_OR_OTHER||LS Mean Difference|7.76|STANDARD_ERROR_OF_MEAN|4.244||0.0725|TWO_SIDED|95.0|-0.73|16.25|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||16.25|-0.73|0.0725
72559016|NCT01243151|144647856|SUPERIORITY_OR_OTHER||LS Mean Difference|6.74|STANDARD_ERROR_OF_MEAN|3.214||0.0405|TWO_SIDED|95.0|0.3|13.18|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||13.18|0.30|0.0405
72559017|NCT01243151|144647856|SUPERIORITY_OR_OTHER||LS Mean Difference|6.27|STANDARD_ERROR_OF_MEAN|3.258||0.0593|TWO_SIDED|95.0|-0.25|12.8|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||12.80|-0.25|0.0593
72559018|NCT01243151|144647856|SUPERIORITY_OR_OTHER||LS Mean Difference|1.76|STANDARD_ERROR_OF_MEAN|3.279||0.5936|TWO_SIDED|95.0|-4.81|8.33|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||8.33|-4.81|0.5936
72559019|NCT01243151|144647856|SUPERIORITY_OR_OTHER||LS Mean Difference|9.78|STANDARD_ERROR_OF_MEAN|3.192||0.0034|TWO_SIDED|95.0|3.38|16.17|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||16.17|3.38|0.0034
72559020|NCT01243151|144647856|SUPERIORITY_OR_OTHER||LS Mean Difference|7.6|STANDARD_ERROR_OF_MEAN|3.428||0.0305|TWO_SIDED|95.0|0.74|14.46|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||14.46|0.74|0.0305
72559021|NCT01243151|144647856|SUPERIORITY_OR_OTHER||LS Mean Difference|5.41|STANDARD_ERROR_OF_MEAN|3.479||0.1252|TWO_SIDED|95.0|-1.55|12.37|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||12.37|-1.55|0.1252
72559022|NCT01243151|144647856|SUPERIORITY_OR_OTHER||LS Mean Difference|3.71|STANDARD_ERROR_OF_MEAN|3.495||0.2923|TWO_SIDED|95.0|-3.28|10.71|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||10.71|-3.28|0.2923
72559023|NCT01243151|144647856|SUPERIORITY_OR_OTHER||LS Mean Difference|7.6|STANDARD_ERROR_OF_MEAN|3.411||0.0297|TWO_SIDED|95.0|0.78|14.43|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||14.43|0.78|0.0297
72387312|NCT03993132|144282991|OTHER|A Cox regression with selected variables based on previous literature, covariate data availability, examination of exposure group differences in the distribution of each covariate, and the association of covariates with the outcomes of interest was applied. The hazard ratio compare Empagliflozin versus Liraglutide (reference).|Hazard Ratio (HR)|0.87|||||TWO_SIDED|95.0|0.72|1.06|||||Hazard ratio compares empagliflozin versus liraglutide (reference).|||1.06|0.72|
72387313|NCT03993132|144282992|OTHER|A Cox regression with selected variables based on previous literature, covariate data availability, examination of exposure group differences in the distribution of each covariate, and the association of covariates with the outcomes of interest was applied. The hazard ratio compare Empagliflozin versus Liraglutide (reference).|Hazard Ratio (HR)|0.98|||||TWO_SIDED|95.0|0.88|1.1|||||Hazard ratio compares empagliflozin versus liraglutide (reference).|||1.10|0.88|
72439787|NCT02528188|144393175|SUPERIORITY||Odds Ratio (OR)|1.16||||0.3193|TWO_SIDED|95.0|0.86|1.57|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 56: \>=90% reduction||1.57|0.86|0.3193
72387314|NCT02805972|144282996|SUPERIORITY|"The null hypothesis is that there would be no difference across the Naloxone and placebo conditions.~The alternative hypothesis is that the cortisol value would be higher in the Naloxone condition than in the placebo condition."|Mean Difference (Final Values)|1.26||||0.067|TWO_SIDED|95.0|0.98|1.61||If the Winsorized value is excluded from analyses altogether, the P value is .012|t-test, 2 sided|Cortisol was log transformed for the statistical test, and the reported mean difference was exponentiated back to the original units of nmol/L below.||We compared cortisol values at 55 minutes, within person, across conditions. We Winsorized one participant's values for the placebo visit where values were between 2-4x above the 99th percentile value in the data and then log-transformed the data.||1.61|0.98|.067
72439788|NCT02528188|144393177|SUPERIORITY||Odds Ratio (OR)|1.22||||0.1772|TWO_SIDED|95.0|0.91|1.62|||Regression, Logistic|||Week 2: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of OA scale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.||1.62|0.91|0.1772
72439789|NCT02528188|144393177|SUPERIORITY||Odds Ratio (OR)|1.42||||0.0154|TWO_SIDED|95.0|1.07|1.89|||Regression, Logistic|||Week 2: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of OA scale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.||1.89|1.07|0.0154
72439790|NCT02528188|144393177|SUPERIORITY||Odds Ratio (OR)|1.4||||0.0105|TWO_SIDED|95.0|1.08|1.81|||Regression, Logistic|||Week 4: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of OA scale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.||1.81|1.08|0.0105
72439791|NCT02528188|144393177|SUPERIORITY||Odds Ratio (OR)|1.63||||0.0002|TWO_SIDED|95.0|1.26|2.1|||Regression, Logistic|||Week 4: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of OA scale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.||2.10|1.26|0.0002
72439792|NCT02528188|144393177|SUPERIORITY||Odds Ratio (OR)|1.11||||0.4007|TWO_SIDED|95.0|0.87|1.43|||Regression, Logistic|||Week 8: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of OA scale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.||1.43|0.87|0.4007
72439793|NCT02528188|144393177|SUPERIORITY||Odds Ratio (OR)|1.37||||0.0116|TWO_SIDED|95.0|1.07|1.75|||Regression, Logistic|||Week 8: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of OA scale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.||1.75|1.07|0.0116
72387315|NCT01903031|144283039|OTHER||||||<|0.001||||||No adjustments for multiple comparisons were made. Statistical significance was declared if p\<0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis: There is no difference in concentrations of Etonogestrel on day 21 between the control arm (NuvaRing and no ART) and NuvaRing with EFV plus ≥2 NRTIs.||||<0.001
72387316|NCT01903031|144283039|OTHER||||||<|0.001||||||No adjustments for multiple comparisons were made. Statistical significance was declared if p\<0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis: There is no difference in concentrations of Etonogestrel on day 21 between the control arm (NuvaRing and no ART) and NuvaRing with ATV/r plus TDF and ≥1 NRTIs.||||<0.001
72387317|NCT01903031|144283040|OTHER||||||<|0.001||||||No adjustments for multiple comparisons were made. Statistical significance was declared if p\<0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis: There is no difference in concentrations of Ethinyl Estradiol on day 21 between the control arm (NuvaRing and no ART) and NuvaRing with EFV plus ≥2 NRTIs.||||<0.001
72387318|NCT01903031|144283040|OTHER|||||||0.004||||||No adjustments for multiple comparisons were made. Statistical significance was declared if p\<0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis: There is no difference in concentrations of Ethinyl Estradiol on day 21 between the control arm (NuvaRing and no ART) and NuvaRing with ATV/r plus TDF and ≥1 NRTIs.||||0.004
72387319|NCT03540030|144283060|OTHER|||||||0.297|||||||Wilcoxon (Mann-Whitney)|||||||.297
72387320|NCT03540030|144283061|OTHER|||||||0.005||||||At the 6 hour time point|Wilcoxon (Mann-Whitney)|||||||0.005
72387321|NCT03540030|144283061|OTHER|||||||0.005|||||||Wilcoxon (Mann-Whitney)|||At the 12 hour time point||||0.005
72387322|NCT03540030|144283062|OTHER|||||||0.0801|||||||Fisher Exact|||||||0.0801
72387323|NCT03540030|144283063|OTHER|||||||0.0154|||||||Chi-squared|||||||0.0154
72387324|NCT03540030|144283064|OTHER|||||||0.2139|||||||Fisher Exact|||||||0.2139
72387325|NCT03540030|144283066|OTHER||||||>|0.99|||||||Fisher Exact|||||||>.99
72387326|NCT03540030|144283067|OTHER|||||||0.9669|||||||Wilcoxon (Mann-Whitney)|||||||0.9669
72387327|NCT03540030|144283068|OTHER|||||||0.9208|||||||Wilcoxon (Mann-Whitney)|||||||.9208
72387328|NCT03540030|144283069|OTHER|||||||0.6481|||||||Wilcoxon (Mann-Whitney)|||For PCS only||||0.6481
72387329|NCT03540030|144283069|OTHER|||||||0.3911|||||||Wilcoxon (Mann-Whitney)|||For MCS only||||0.3911
72387330|NCT03540030|144283070|OTHER||||||>|0.99|||||||Fisher Exact|||||||>.99
72387331|NCT03540030|144283071|OTHER|||||||0.3177|||||||Fisher Exact|||||||0.3177
72387332|NCT03540030|144283072|OTHER||||||>|0.99|||||||Fisher Exact|||||||>.99
72387333|NCT03540030|144283073|OTHER|||||||0.2349|||||||Fisher Exact|||||||0.2349
72387334|NCT03540030|144283074|OTHER|||||||0.7892|||||||Wilcoxon (Mann-Whitney)|||||||0.7892
72387335|NCT03540030|144283075|OTHER|||||||0.2023|||||||Wilcoxon (Mann-Whitney)|||For PCS only||||0.2023
72387336|NCT03540030|144283075|OTHER|||||||0.2486|||||||Wilcoxon (Mann-Whitney)|||For MCS only||||0.2486
72387337|NCT00347360|144283094|SUPERIORITY_OR_OTHER||||||>|0.1||95.0|||||Hung AVE test, see comments|Hung AVE Test Statistic: -0.41499. Tests an average of the minimum gains (in response) for the 9 combination cells over corresponding monotherapies.||This is an omnibus test to investigate the existence of at least one combination dose that outperforms its components.||||>0.1
72387338|NCT00347360|144283095|SUPERIORITY_OR_OTHER||||||>|0.1||95.0|||||Hung AVE test, see comments|Hung AVE Test Statistic: -0.00485. Tests an average of the minimum gains (in response) for the 9 combination cells over corresponding monotherapies.||This is an omnibus test to investigate the existence of at least one combination dose that outperforms its components.||||>0.1
72439794|NCT02528188|144393177|SUPERIORITY||Odds Ratio (OR)|0.95||||0.6279|TWO_SIDED|95.0|0.76|1.18|||Regression, Logistic|||Week 16: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of OA scale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.||1.18|0.76|0.6279
72439795|NCT02528188|144393177|SUPERIORITY||Odds Ratio (OR)|1.09||||0.4674|TWO_SIDED|95.0|0.87|1.35|||Regression, Logistic|||Week 16: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of OA scale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.||1.35|0.87|0.4674
72439796|NCT02528188|144393177|SUPERIORITY||Odds Ratio (OR)|0.89||||0.3135|TWO_SIDED|95.0|0.71|1.12|||Regression, Logistic|||Week 24: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of OA scale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.||1.12|0.71|0.3135
72439797|NCT02528188|144393177|SUPERIORITY||Odds Ratio (OR)|1.04||||0.7581|TWO_SIDED|95.0|0.83|1.3|||Regression, Logistic|||Week 24: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of OA scale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.||1.30|0.83|0.7581
72439798|NCT02528188|144393177|SUPERIORITY||Odds Ratio (OR)|0.92||||0.4504|TWO_SIDED|95.0|0.73|1.15|||Regression, Logistic|||Week 32: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of OA scale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.||1.15|0.73|0.4504
72495759|NCT00168831|144520940|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.445|STANDARD_ERROR_OF_MEAN|1.059||0.0012||95.0|||||ANCOVA|The means are adjusted for centre, smoking status at entry and baseline value.|Tiotropium Respimat 10mcg - Placebo|||||0.0012
72495760|NCT00168831|144520941|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.053|STANDARD_ERROR_OF_MEAN|0.165|<|0.0001||95.0|||||ANCOVA|The means are adjusted for centre, smoking status at entry and baseline value.|Tiotropium Respimat 5mcg - Placebo|||||<0.0001
72495761|NCT00168831|144520941|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.075|STANDARD_ERROR_OF_MEAN|0.166|<|0.0001||95.0|||||ANCOVA|The means are adjusted for centre, smoking status at entry and baseline value.|Tiotropium Respimat 10mcg - Placebo|||||<0.0001
72495762|NCT00168831|144520942|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.782||||0.0002|TWO_SIDED|95.0|0.687|0.89|||Poisson regression||Tiotropium Respimat 5mcg vs. Placebo|||0.890|0.687|0.0002
72495763|NCT00168831|144520942|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.725|||<|0.0001|TWO_SIDED|95.0|0.635|0.828|||Poisson regression||Tiotropium Respimat 10mcg vs. Placebo|||0.828|0.635|<0.0001
72495764|NCT00168831|144520986|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.24|STANDARD_ERROR_OF_MEAN|0.037|<|0.0001||95.0|||||ANCOVA|ANCOVA analysis with terms for treatment, smoking status at entry, centre and baseline value.|Tiotropium Respimat 5mcg - Placebo|Analysis for week 48||||<0.0001
72495765|NCT00168831|144520986|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.252|STANDARD_ERROR_OF_MEAN|0.037|<|0.0001||95.0|||||ANCOVA||Tiotropium Respimat 10mcg - Placebo|Analysis for week 48||||<0.0001
72559024|NCT01243151|144647857|SUPERIORITY_OR_OTHER||LS Mean Difference|-26.35|STANDARD_ERROR_OF_MEAN|4.117|<|0.0001|TWO_SIDED|95.0|-34.59|-18.1|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-18.10|-34.59|<0.0001
72559025|NCT01243151|144647857|SUPERIORITY_OR_OTHER||LS Mean Difference|-24.29|STANDARD_ERROR_OF_MEAN|4.325|<|0.0001|TWO_SIDED|95.0|-32.95|-15.63|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-15.63|-32.95|<0.0001
72439799|NCT02528188|144393177|SUPERIORITY||Odds Ratio (OR)|0.88||||0.2629|TWO_SIDED|95.0|0.7|1.1|||Regression, Logistic|||Week 32: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of OA scale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.||1.10|0.70|0.2629
72439800|NCT02528188|144393177|SUPERIORITY||Odds Ratio (OR)|0.95||||0.6763|TWO_SIDED|95.0|0.75|1.2|||Regression, Logistic|||Week 40: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of OA scale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.||1.20|0.75|0.6763
72495766|NCT00168831|144520987|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.183|STANDARD_ERROR_OF_MEAN|0.018|<|0.0001||95.0|||||ANCOVA|ANCOVA analysis with terms for treatment, smoking status at entry, centre and baseline value.|Tiotropium Respimat 5mcg - Placebo|Analysis for week 48||||<0.0001
72495767|NCT00168831|144520987|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.212|STANDARD_ERROR_OF_MEAN|0.018|<|0.0001||95.0|||||ANCOVA|ANCOVA analysis with terms for treatment, smoking status at entry, centre and baseline value.|Tiotropium Respimat 10mcg - Placebo|Analysis for week 48||||<0.0001
72495768|NCT00168831|144520988|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.369|STANDARD_ERROR_OF_MEAN|0.04|<|0.0001||95.0|||||ANCOVA|ANCOVA analysis with terms for treatment, smoking status at entry, centre and baseline value.|Tiotropium Respimat 5mcg - Placebo|Analysis for week 48||||<0.0001
72495769|NCT00168831|144520988|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.393|STANDARD_ERROR_OF_MEAN|0.04|<|0.0001||95.0|||||ANCOVA|ANCOVA analysis with terms for treatment, smoking status at entry, centre and baseline value.|Tiotropium Respimat 10mcg - Placebo|Analysis for week 48||||<0.0001
72495770|NCT00168831|144520989|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|27.9|STANDARD_ERROR_OF_MEAN|4.9|<|0.0001||95.0|||||ANCOVA|ANCOVA analysis with terms for treatment, centre,smoking status at entry and baseline value.|Tiotropium Respimat 5mcg - Placebo|Analysis for week 48||||<0.0001
72495771|NCT00168831|144520989|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|31.7|STANDARD_ERROR_OF_MEAN|4.9|<|0.0001||95.0|||||ANCOVA|ANCOVA analysis with terms for treatment, centre,smoking status at entry and baseline value.|Tiotropium Respimat 10mcg - Placebo|Analysis for week 48||||<0.0001
72495772|NCT00168831|144520990|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|32.0|STANDARD_ERROR_OF_MEAN|4.9|<|0.0001||95.0|||||ANCOVA|ANCOVA analysis with terms for treatment, centre,smoking status at entry and baseline value.|Tiotropium Respimat 5mcg - Placebo|Analysis for week 48||||<0.0001
72439801|NCT02528188|144393177|SUPERIORITY||Odds Ratio (OR)|1.01||||0.9456|TWO_SIDED|95.0|0.8|1.27|||Regression, Logistic|||Week 40: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of OA scale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.||1.27|0.80|0.9456
72559026|NCT01243151|144647857|SUPERIORITY_OR_OTHER||LS Mean Difference|-31.2|STANDARD_ERROR_OF_MEAN|4.182|<|0.0001|TWO_SIDED|95.0|-39.58|-22.83|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-22.83|-39.58|<0.0001
72559027|NCT01243151|144647857|SUPERIORITY_OR_OTHER||LS Mean Difference|-30.43|STANDARD_ERROR_OF_MEAN|4.169|<|0.0001|TWO_SIDED|95.0|-38.78|-22.08|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-22.08|-38.78|<0.0001
72439802|NCT02528188|144393177|SUPERIORITY||Odds Ratio (OR)|0.96||||0.752|TWO_SIDED|95.0|0.76|1.22|||Regression, Logistic|||Week 48: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of OA scale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.||1.22|0.76|0.7520
72439803|NCT02528188|144393177|SUPERIORITY||Odds Ratio (OR)|1.0||||0.9981|TWO_SIDED|95.0|0.79|1.26|||Regression, Logistic|||Week 48: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of OA scale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.||1.26|0.79|0.9981
72439804|NCT02528188|144393177|SUPERIORITY||Odds Ratio (OR)|0.93||||0.5284|TWO_SIDED|95.0|0.74|1.17|||Regression, Logistic|||Week 56: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of OA scale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.||1.17|0.74|0.5284
72439805|NCT02528188|144393177|SUPERIORITY||Odds Ratio (OR)|0.89||||0.322|TWO_SIDED|95.0|0.7|1.12|||Regression, Logistic|||Week 56: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of OA scale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.||1.12|0.70|0.3220
72439806|NCT02528188|144393178|SUPERIORITY||LS Mean Difference|0.09|STANDARD_ERROR_OF_MEAN|0.06||0.112|TWO_SIDED|95.0|-0.02|0.2|||ANCOVA|||Week 1: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.||0.20|-0.02|0.1120
72559028|NCT01243151|144647857|SUPERIORITY_OR_OTHER||LS Mean Difference|-33.3|STANDARD_ERROR_OF_MEAN|5.055|<|0.0001|TWO_SIDED|95.0|-43.42|-23.19|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-23.19|-43.42|<0.0001
72559029|NCT01243151|144647857|SUPERIORITY_OR_OTHER||LS Mean Difference|-34.14|STANDARD_ERROR_OF_MEAN|5.255|<|0.0001|TWO_SIDED|95.0|-44.65|-23.63|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-23.63|-44.65|<0.0001
72559030|NCT01243151|144647857|SUPERIORITY_OR_OTHER||LS Mean Difference|-42.57|STANDARD_ERROR_OF_MEAN|5.194|<|0.0001|TWO_SIDED|95.0|-52.96|-32.18|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-32.18|-52.96|<0.0001
72439807|NCT02528188|144393178|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.06||0.9686|TWO_SIDED|95.0|-0.11|0.11|||ANCOVA|||Week 1: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.||0.11|-0.11|0.9686
72439808|NCT02528188|144393178|SUPERIORITY||LS Mean Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.08||0.1589|TWO_SIDED|95.0|-0.25|0.04|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.||0.04|-0.25|0.1589
72439809|NCT02528188|144393178|SUPERIORITY||LS Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.08||0.472|TWO_SIDED|95.0|-0.2|0.09|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.||0.09|-0.20|0.4720
72439810|NCT02528188|144393178|SUPERIORITY||LS Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.08||0.032|TWO_SIDED|95.0|-0.33|-0.01|||ANCOVA|||Week 3: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.||-0.01|-0.33|0.0320
72495773|NCT00168831|144520990|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|39.1|STANDARD_ERROR_OF_MEAN|4.9|<|0.0001||95.0|||||ANCOVA|ANCOVA analysis with terms for treatment, centre,smoking status at entry and baseline value.|Tiotropium Respimat 10mcg - Placebo|Analysis for week 48||||<0.0001
72559031|NCT01243151|144647857|SUPERIORITY_OR_OTHER||LS Mean Difference|-41.87|STANDARD_ERROR_OF_MEAN|5.097|<|0.0001|TWO_SIDED|95.0|-52.07|-31.67|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-31.67|-52.07|<0.0001
72559032|NCT01243151|144647857|SUPERIORITY_OR_OTHER||LS Mean Difference|-37.75|STANDARD_ERROR_OF_MEAN|4.343|<|0.0001|TWO_SIDED|95.0|-46.46|-29.05|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-29.05|-46.46|<0.0001
72559033|NCT01243151|144647857|SUPERIORITY_OR_OTHER||LS Mean Difference|-40.98|STANDARD_ERROR_OF_MEAN|4.519|<|0.0001|TWO_SIDED|95.0|-50.04|-31.93|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-31.93|-50.04|<0.0001
72439811|NCT02528188|144393178|SUPERIORITY||LS Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.08||0.3336|TWO_SIDED|95.0|-0.24|0.08|||ANCOVA|||Week 3: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.||0.08|-0.24|0.3336
72439812|NCT02528188|144393178|SUPERIORITY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.09||0.0005|TWO_SIDED|95.0|-0.47|-0.13|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.||-0.13|-0.47|0.0005
72439813|NCT02528188|144393178|SUPERIORITY||LS Mean Difference|-0.33|STANDARD_ERROR_OF_MEAN|0.09||0.0001|TWO_SIDED|95.0|-0.5|-0.16|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.||-0.16|-0.50|0.0001
72439814|NCT02528188|144393178|SUPERIORITY||LS Mean Difference|-0.37|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001|TWO_SIDED|95.0|-0.55|-0.18|||ANCOVA|||Week 6: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.||-0.18|-0.55|<0.0001
72559034|NCT01243151|144647857|SUPERIORITY_OR_OTHER||LS Mean Difference|-46.98|STANDARD_ERROR_OF_MEAN|4.441|<|0.0001|TWO_SIDED|95.0|-55.88|-38.08|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-38.08|-55.88|<0.0001
72559035|NCT01243151|144647857|SUPERIORITY_OR_OTHER||LS Mean Difference|-45.77|STANDARD_ERROR_OF_MEAN|4.363|<|0.0001|TWO_SIDED|95.0|-54.52|-37.03|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-37.03|-54.52|<0.0001
72559036|NCT01243151|144647857|SUPERIORITY_OR_OTHER||LS Mean Difference|-38.61|STANDARD_ERROR_OF_MEAN|4.616|<|0.0001|TWO_SIDED|95.0|-47.85|-29.37|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-29.37|-47.85|<0.0001
72559037|NCT01243151|144647857|SUPERIORITY_OR_OTHER||LS Mean Difference|-41.19|STANDARD_ERROR_OF_MEAN|4.795|<|0.0001|TWO_SIDED|95.0|-50.78|-31.6|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-31.60|-50.78|<0.0001
72439815|NCT02528188|144393178|SUPERIORITY||LS Mean Difference|-0.48|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001|TWO_SIDED|95.0|-0.66|-0.3|||ANCOVA|||Week 6: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.||-0.30|-0.66|<0.0001
72439816|NCT02528188|144393178|SUPERIORITY||LS Mean Difference|-0.24|STANDARD_ERROR_OF_MEAN|0.09||0.0115|TWO_SIDED|95.0|-0.42|-0.05|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.||-0.05|-0.42|0.0115
72439817|NCT02528188|144393178|SUPERIORITY||LS Mean Difference|-0.45|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001|TWO_SIDED|95.0|-0.63|-0.26|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.||-0.26|-0.63|<0.0001
72439818|NCT02528188|144393178|SUPERIORITY||LS Mean Difference|-0.36|STANDARD_ERROR_OF_MEAN|0.1||0.0002|TWO_SIDED|95.0|-0.56|-0.17|||ANCOVA|||Week 10: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.||-0.17|-0.56|0.0002
72439819|NCT02528188|144393178|SUPERIORITY||LS Mean Difference|-0.48|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001|TWO_SIDED|95.0|-0.67|-0.28|||ANCOVA|||Week 10: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.||-0.28|-0.67|<0.0001
72495774|NCT00168831|144520991|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.2||0.0169||95.0|||||ANCOVA|ANCOVA analysis with terms for treatment, centre,smoking status at entry and baseline value.|Tiotropium Respimat 5mcg - Placebo|Analysis for week 48||||0.0169
72559038|NCT01243151|144647857|SUPERIORITY_OR_OTHER||LS Mean Difference|-49.75|STANDARD_ERROR_OF_MEAN|4.722|<|0.0001|TWO_SIDED|95.0|-59.2|-40.3|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-40.30|-59.20|<0.0001
72559039|NCT01243151|144647857|SUPERIORITY_OR_OTHER||LS Mean Difference|-48.04|STANDARD_ERROR_OF_MEAN|4.639|<|0.0001|TWO_SIDED|95.0|-57.33|-38.76|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-38.76|-57.33|<0.0001
72387339|NCT02187744|144283120|NON_INFERIORITY_OR_EQUIVALENCE|The hypothesis to be tested in this study is the percentage of participants with steady state (Cycle 5) Ctrough \>20 μg/mL of PF-05280014 is non-inferior to trastuzumab-EU using a margin of -12.5%.|Mean Difference (Final Values)|-0.76|STANDARD_ERROR_OF_MEAN|3.7|||TWO_SIDED|95.0|-8.02|6.49|||||Stratified analysis was based on the normal approximation to the binomial distribution, adjusting for the randomization strata of primary tumor size, estrogen receptor status and by progesterone receptor status.|||6.49|-8.02|
72387340|NCT02187744|144283120|NON_INFERIORITY_OR_EQUIVALENCE|The hypothesis to be tested in this study is the percentage of participants with steady state (Cycle 5) Ctrough \>20 μg/mL of PF-05280014 is non-inferior to trastuzumab-EU using a margin of -12.5%.|Mean Difference (Final Values)|-1.18|STANDARD_ERROR_OF_MEAN|3.78|||TWO_SIDED|95.0|-8.59|6.23|||||Unstratified analysis.|||6.23|-8.59|
72387341|NCT02187744|144283122|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.81|STANDARD_ERROR_OF_MEAN|7.03|||TWO_SIDED|95.0|-16.58|10.96|||||Stratified analysis was based on the normal approximation to the binomial distribution, adjusting for the randomization strata of primary tumor size, estrogen receptor status and by progesterone receptor status.|||10.96|-16.58|
72387342|NCT02187744|144283122|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.0|STANDARD_ERROR_OF_MEAN|7.35|||TWO_SIDED|95.0|-17.4|11.4|||||Unstratified analysis.|||11.40|-17.40|
72387343|NCT02187744|144283123|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.96|STANDARD_ERROR_OF_MEAN|5.09|||TWO_SIDED|95.0|-4.01|15.94|||||Stratified analysis was based on the normal approximation to the binomial distribution, adjusting for the randomization strata of primary tumor size, estrogen receptor status and by progesterone receptor status.|||15.94|-4.01|
72387344|NCT02187744|144283123|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.1|STANDARD_ERROR_OF_MEAN|5.19|||TWO_SIDED|95.0|-4.08|16.27|||||Unstratified analysis.|||16.27|-4.08|
72387345|NCT00144391|144283144|SUPERIORITY|||||||0.08|||||||t-test, 2 sided|||||||0.08
72387346|NCT04680052|144283183|SUPERIORITY||Hazard Ratio (HR)|0.434|||<|0.0001|TWO_SIDED|95.0|0.324|0.58|||stratified Log Rank||The hazard ratio was estimated using a stratified Cox proportional hazards model.|||0.580|0.324|<0.0001
72387347|NCT04680052|144283185|SUPERIORITY||Hazard Ratio (HR)|0.5|||<|0.0001|TWO_SIDED|95.0|0.383|0.653|||stratified Log Rank||The hazard ratio was estimated using a stratified Cox proportional hazards model.|||0.653|0.383|<0.0001
72387348|NCT04680052|144283186|SUPERIORITY||Odds Ratio (OR)|1.5||||0.0286|TWO_SIDED|95.0|1.04|2.13|||stratified Cochran-Mantel-Haenszel||The strata information was based on the data obtained from the interactive response technology that was used for randomization.|||2.13|1.04|0.0286
72387349|NCT04680052|144283188|SUPERIORITY||Hazard Ratio (HR)|0.587||||0.1061|TWO_SIDED|95.0|0.306|1.128|||stratified Log Rank||The hazard ratio was estimated using a stratified Cox proportional hazards model.|||1.128|0.306|0.1061
72387350|NCT04680052|144283189|SUPERIORITY|Only primary and key secondary endpoints were formally tested; this endpoint was not formally tested.|Odds Ratio (OR)|1.5||||0.0221|TWO_SIDED|95.0|1.06|2.03|||stratified Cochran-Mantel-Haenszel||The strata information was based on the data obtained from the interactive response technology that was used for randomization.|||2.03|1.06|0.0221
72387351|NCT04680052|144283190|SUPERIORITY|Only primary and key secondary endpoints were formally tested; this endpoint was not formally tested.|Odds Ratio (OR)|1.4||||0.4093|TWO_SIDED|95.0|0.61|3.33|||stratified Cochran-Mantel-Haenszel||The strata information was based on the data obtained from the interactive response technology that was used for randomization.|||3.33|0.61|0.4093
72387352|NCT04680052|144283191|SUPERIORITY|Only primary and key secondary endpoints were formally tested; this endpoint was not formally tested.|Odds Ratio (OR)|1.5||||0.2874|TWO_SIDED|95.0|0.69|3.47|||stratified Cochran-Mantel-Haenszel||The strata information was based on the data obtained from the interactive response technology that was used for randomization.|||3.47|0.69|0.2874
72387353|NCT04680052|144283192|SUPERIORITY|Only primary and key secondary endpoints were formally tested; this endpoint was not formally tested.|Odds Ratio (OR)|2.0||||0.0014|TWO_SIDED|95.0|1.3|3.02|||stratified Cochran-Mantel-Haenszel||The strata information was based on the data obtained from the interactive response technology that was used for randomization.|||3.02|1.30|0.0014
72387354|NCT04680052|144283193|SUPERIORITY|Only primary and key secondary endpoints were formally tested; this endpoint was not formally tested.|Odds Ratio (OR)|1.9||||0.0009|TWO_SIDED|95.0|1.29|2.74|||Cochran-Mantel-Haenszel||The strata information was based on the data obtained from the interactive response technology that was used for randomization.|||2.74|1.29|0.0009
72387355|NCT04680052|144283195|SUPERIORITY|Only primary and key secondary endpoints were formally tested; this endpoint was not formally tested.|Hazard Ratio (HR)|0.473|||<|0.0001|TWO_SIDED|95.0|0.33|0.678|||stratified Log Rank||The hazard ratio was estimated using a stratified Cox proportional hazards model.|||0.678|0.330|<0.0001
72387356|NCT04680052|144283197|SUPERIORITY|Only primary and key secondary endpoints were formally tested; this endpoint was not formally tested.|Hazard Ratio (HR)|0.55||||0.0003|TWO_SIDED|95.0|0.397|0.763|||stratified Log Rank||The hazard ratio was estimated using a stratified Cox proportional hazards model.|||0.763|0.397|0.0003
72387357|NCT04680052|144283199|SUPERIORITY|Only primary and key secondary endpoints were formally tested; this endpoint was not formally tested.|Hazard Ratio (HR)|0.85||||0.5837|TWO_SIDED|95.0|0.476|1.519|||stratified Log Rank||The hazard ratio was estimated using a stratified Cox proportional hazards model.|||1.519|0.476|0.5837
72387358|NCT04680052|144283201|SUPERIORITY|Only primary and key secondary endpoints were formally tested; this endpoint was not formally tested.|Hazard Ratio (HR)|0.407|||<|0.0001|TWO_SIDED|95.0|0.294|0.563|||stratified Log Rank||The hazard ratio was estimated using a stratified Cox proportional hazards model.|||0.563|0.294|<0.0001
72387359|NCT04680052|144283203|SUPERIORITY|Only primary and key secondary endpoints were formally tested; this endpoint was not formally tested.|Hazard Ratio (HR)|0.481|||<|0.0001|TWO_SIDED|95.0|0.357|0.647|||stratified Log Rank||The hazard ratio was estimated using a stratified Cox proportional hazards model.|||0.647|0.357|<0.0001
72439820|NCT02528188|144393178|SUPERIORITY||LS Mean Difference|-0.37|STANDARD_ERROR_OF_MEAN|0.1||0.0002|TWO_SIDED|95.0|-0.57|-0.18|||ANCOVA|||Week 12: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.||-0.18|-0.57|0.0002
72439821|NCT02528188|144393178|SUPERIORITY||LS Mean Difference|-0.45|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001|TWO_SIDED|95.0|-0.64|-0.25|||ANCOVA|||Week 12: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.||-0.25|-0.64|<0.0001
72387360|NCT04680052|144283204|SUPERIORITY|Only primary and key secondary endpoints were formally tested; this endpoint was not formally tested.|Odds Ratio (OR)|2.2||||0.0003|TWO_SIDED|95.0|1.43|3.43|||stratified Cochran-Mantel-Haenszel||The strata information was based on the data obtained from the interactive response technology that was used for randomization.|||3.43|1.43|0.0003
72387361|NCT04680052|144283205|SUPERIORITY|Only primary and key secondary endpoints were formally tested; this endpoint was not formally tested.|Odds Ratio (OR)|2.0||||0.0005|TWO_SIDED|95.0|1.33|2.86|||stratified Cochran-Mantel-Haenszel||The strata information was based on the data obtained from the interactive response technology that was used for randomization.|||2.86|1.33|0.0005
72439822|NCT02528188|144393178|SUPERIORITY||LS Mean Difference|-0.24|STANDARD_ERROR_OF_MEAN|0.1||0.0238|TWO_SIDED|95.0|-0.44|-0.03|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.||-0.03|-0.44|0.0238
72439823|NCT02528188|144393178|SUPERIORITY||LS Mean Difference|-0.34|STANDARD_ERROR_OF_MEAN|0.11||0.0011|TWO_SIDED|95.0|-0.55|-0.14|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.||-0.14|-0.55|0.0011
72439824|NCT02528188|144393178|SUPERIORITY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.11||0.0064|TWO_SIDED|95.0|-0.51|-0.08|||ANCOVA|||Week 20: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.||-0.08|-0.51|0.0064
72439825|NCT02528188|144393178|SUPERIORITY||LS Mean Difference|-0.33|STANDARD_ERROR_OF_MEAN|0.11||0.0025|TWO_SIDED|95.0|-0.54|-0.12|||ANCOVA|||Week 20: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.||-0.12|-0.54|0.0025
72439826|NCT02528188|144393178|SUPERIORITY||LS Mean Difference|-0.23|STANDARD_ERROR_OF_MEAN|0.12||0.0589|TWO_SIDED|95.0|-0.48|0.01|||ANCOVA|||Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.||0.01|-0.48|0.0589
72495775|NCT00168831|144520991|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001||95.0|||||ANCOVA|ANCOVA analysis with terms for treatment, centre,smoking status at entry and baseline value.|Tiotropium Respimat 10mcg - Placebo|Analysis for week 48||||<0.0001
72495776|NCT04652804|144521014|SUPERIORITY||Risk Ratio (RR)|1.09|||||TWO_SIDED|95.0|1.0|1.19||||||Reference group: Low Intensity Intervention||1.19|1.00|
72559040|NCT01243151|144647858|SUPERIORITY_OR_OTHER||LS Mean Difference|-22.7|STANDARD_ERROR_OF_MEAN|4.211|<|0.0001|TWO_SIDED|95.0|-31.06|-14.34|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-14.34|-31.06|<0.0001
72387362|NCT04680052|144283207|SUPERIORITY|Only primary and key secondary endpoints were formally tested; this endpoint was not formally tested.|Hazard Ratio (HR)|0.461|||<|0.0001|TWO_SIDED|95.0|0.312|0.681|||stratified Log Rank||The hazard ratio was estimated using a stratified Cox proportional hazards model.|||0.681|0.312|<0.0001
72439827|NCT02528188|144393178|SUPERIORITY||LS Mean Difference|-0.29|STANDARD_ERROR_OF_MEAN|0.12||0.018|TWO_SIDED|95.0|-0.53|-0.05|||ANCOVA|||Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.||-0.05|-0.53|0.0180
72495777|NCT04652804|144521014|SUPERIORITY||Risk Ratio (RR)|0.97|||||TWO_SIDED|95.0|0.9|1.05||||||Reference Group: Low Intensity Intervention||1.05|0.90|
72495778|NCT04652804|144521014|SUPERIORITY||Risk Ratio (RR)|0.96|||||TWO_SIDED|95.0|0.8|1.15||||||Reference group: High Intensity Intervention||1.15|0.80|
72495779|NCT04652804|144521014|SUPERIORITY||Risk Ratio (RR)|0.89|||||TWO_SIDED|95.0|0.77|1.04||||||Reference group: High Intensity Intervention||1.04|0.77|
72495780|NCT04428411|144521103|OTHER|||||||0.35|||||||t-test, 2 sided|||||||0.35
72495781|NCT04428411|144521104|OTHER|||||||0.07|||||||t-test, 2 sided|||||||0.07
72495782|NCT04428411|144521105|OTHER|||||||0.41|||||||t-test, 2 sided|||||||0.41
72495783|NCT04428411|144521106|OTHER|||||||0.01|||||||t-test, 2 sided|||||||0.01
72559041|NCT01243151|144647858|SUPERIORITY_OR_OTHER||LS Mean Difference|-18.6|STANDARD_ERROR_OF_MEAN|4.315|<|0.0001|TWO_SIDED|95.0|-27.17|-10.03|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-10.03|-27.17|<0.0001
72559042|NCT01243151|144647858|SUPERIORITY_OR_OTHER||LS Mean Difference|-27.97|STANDARD_ERROR_OF_MEAN|4.274|<|0.0001|TWO_SIDED|95.0|-36.46|-19.49|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-19.49|-36.46|<0.0001
72495784|NCT04428411|144521107|OTHER|||||||0.02|||||||t-test, 2 sided|||||||0.02
72495785|NCT04428411|144521108|OTHER|||||||0.09|||||||t-test, 2 sided|||||||0.09
72559043|NCT01243151|144647858|SUPERIORITY_OR_OTHER||LS Mean Difference|-24.89|STANDARD_ERROR_OF_MEAN|4.207|<|0.0001|TWO_SIDED|95.0|-33.24|-16.54|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-16.54|-33.24|<0.0001
72559044|NCT01243151|144647858|SUPERIORITY_OR_OTHER||LS Mean Difference|-28.89|STANDARD_ERROR_OF_MEAN|4.211|<|0.0001|TWO_SIDED|95.0|-37.25|-20.53|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-20.53|-37.25|<0.0001
72387363|NCT04680052|144283209|SUPERIORITY|Only primary and key secondary endpoints were formally tested; this endpoint was not formally tested.|Hazard Ratio (HR)|1.192||||0.7469|TWO_SIDED|95.0|0.409|3.475|||stratified Log Rank||The hazard ratio was estimated using a stratified Cox proportional hazards model.|||3.475|0.409|0.7469
72387364|NCT06956170|144283218|OTHER||Hazard Ratio (HR)|0.53|||||TWO_SIDED|95.0|0.1|2.78|||||Hazard ratio was estimated using an unstratified Cox Proportional Hazard model with treatment arm as an explanatory variable.|||2.78|0.10|
72387365|NCT02400333|144283247|SUPERIORITY_OR_OTHER||Geometric mean ratio|84.85|||||TWO_SIDED|90.0|76.77|93.78||||||Statistical assessment of ticagrelor relative bioavailability following ticagrelor OD tablets administered with water compared to ticagrelor IR tablets.||93.78|76.77|
72387366|NCT02400333|144283247|SUPERIORITY_OR_OTHER||Geometric mean ratio|96.61|||||TWO_SIDED|95.0|88.22|105.79||||||Statistical assessment of ticagrelor relative bioavailability following ticagrelor OD tablets administered without water compared to ticagrelor IR tablets.||105.79|88.22|
72387367|NCT02400333|144283247|SUPERIORITY_OR_OTHER||Geometric mean ratio|92.16|||||TWO_SIDED|95.0|85.59|99.25||||||Statistical assessment of ticagrelor relative bioavailability following ticagrelor OD tablets suspended in water and administered through NG tube compared to ticagrelor IR tablets.||99.25|85.59|
72387368|NCT02400333|144283247|SUPERIORITY_OR_OTHER||Geometric mean ratio|89.84|||||TWO_SIDED|95.0|82.03|98.39||||||Statistical assessment of metabolite AR-C124910XX relative bioavailability following ticagrelor OD tablets administered with water compared to ticagrelor IR tablets.||98.39|82.03|
72387369|NCT02400333|144283247|SUPERIORITY_OR_OTHER||Geometric mean ratio|97.45|||||TWO_SIDED|95.0|90.53|104.9||||||Statistical assessment of metabolite AR-C124910XX relative bioavailability following ticagrelor OD tablets administered without water compared to ticagrelor IR tablets.||104.90|90.53|
72387370|NCT02400333|144283247|SUPERIORITY_OR_OTHER||Geometric mean ratio|97.07|||||TWO_SIDED|95.0|90.83|103.74||||||Statistical assessment of metabolite AR-C124910XX relative bioavailability following ticagrelor OD tablets suspended in water and administered through NG tube compared to ticagrelor IR tablets.||103.74|90.83|
72387371|NCT02400333|144283248|SUPERIORITY_OR_OTHER||Geometric mean ratio|95.04|||||TWO_SIDED|95.0|90.33|99.99||||||Statistical assessment of ticagrelor relative bioavailability following ticagrelor OD tablets administered with water compared to ticagrelor IR tablets.||99.99|90.33|
72387372|NCT02400333|144283248|SUPERIORITY_OR_OTHER||Geometric mean ratio|95.41|||||TWO_SIDED|95.0|89.94|101.21||||||Statistical assessment of ticagrelor relative bioavailability following ticagrelor OD tablets administered without water compared to ticagrelor IR tablets.||101.21|89.94|
72387373|NCT02400333|144283248|SUPERIORITY_OR_OTHER||Geometric mean ratio|94.66|||||TWO_SIDED|95.0|90.53|98.98||||||Statistical assessment of ticagrelor relative bioavailability following ticagrelor OD tablets suspended in water and administered through NG tube compared to ticagrelor IR tablets.||98.98|90.53|
72387374|NCT02400333|144283248|SUPERIORITY_OR_OTHER||Geometric mean ratio|94.67|||||TWO_SIDED|95.0|90.94|98.56||||||Statistical assessment of metabolite AR-C124910XX relative bioavailability following ticagrelor OD tablets administered with water compared to ticagrelor IR tablets.||98.56|90.94|
72387375|NCT02400333|144283248|SUPERIORITY_OR_OTHER||Geometric mean ratio|96.0|||||TWO_SIDED|95.0|91.87|100.33||||||Statistical assessment of metabolite AR-C124910XX relative bioavailability following ticagrelor OD tablets administered without water compared to ticagrelor IR tablets.||100.33|91.87|
72387376|NCT02400333|144283248|SUPERIORITY_OR_OTHER||Geometric mean ratio|96.56|||||TWO_SIDED|95.0|93.08|100.17||||||Statistical assessment of metabolite AR-C124910XX relative bioavailability following ticagrelor OD tablets suspended in water and administered through NG tube compared to ticagrelor IR tablets.||100.17|93.08|
72387377|NCT02400333|144283249|SUPERIORITY_OR_OTHER||Geometric mean ratio|94.96|||||TWO_SIDED|95.0|90.27|99.89||||||Statistical assessment of ticagrelor relative bioavailability following ticagrelor OD tablets administered with water compared to ticagrelor IR tablets.||99.89|90.27|
72387378|NCT02400333|144283249|SUPERIORITY_OR_OTHER||Geometric mean ratio|95.24|||||TWO_SIDED|95.0|89.81|100.99||||||Statistical assessment of ticagrelor relative bioavailability following ticagrelor OD tablets administered without water compared to ticagrelor IR tablets.||100.99|89.81|
72495786|NCT04428411|144521109|OTHER|||||||0.31|||||||t-test, 2 sided|||||||0.31
72495787|NCT04428411|144521110|OTHER||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
72495788|NCT04428411|144521111|OTHER||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
72495789|NCT04428411|144521112|OTHER|||||||0.0001|||||||t-test, 2 sided|||Comparison between Baseline and Month 4||||0.0001
72495790|NCT04428411|144521112|OTHER|||||||0.0001|||||||t-test, 2 sided|||Comparison between Baseline and Month 12||||0.0001
72495791|NCT04428411|144521113|OTHER|||||||0.0001|||||||t-test, 2 sided|||Comparison between Baseline and Month 4||||0.0001
72495792|NCT04428411|144521113|OTHER|||||||0.0001|||||||t-test, 2 sided|||Comparison between Baseline and Month 12||||0.0001
72439828|NCT02528188|144393178|SUPERIORITY||LS Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.13||0.0944|TWO_SIDED|95.0|-0.47|0.04|||ANCOVA|||Week 32: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.||0.04|-0.47|0.0944
72439829|NCT02528188|144393178|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.13||0.1198|TWO_SIDED|95.0|-0.45|0.05|||ANCOVA|||Week 32: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.||0.05|-0.45|0.1198
72439830|NCT02528188|144393178|SUPERIORITY||LS Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.13||0.1837|TWO_SIDED|95.0|-0.43|0.08|||ANCOVA|||Week 40: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.||0.08|-0.43|0.1837
72439831|NCT02528188|144393178|SUPERIORITY||LS Mean Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.13||0.317|TWO_SIDED|95.0|-0.39|0.13|||ANCOVA|||Week 40: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.||0.13|-0.39|0.3170
72495793|NCT04428411|144521114|OTHER|||||||0.0001|||||||t-test, 2 sided|||Comparison between Baseline and Month 4||||0.0001
72495794|NCT04428411|144521114|OTHER|||||||0.0001|||||||t-test, 2 sided|||Comparison between Baseline and Month 12||||0.0001
72495795|NCT02063035|144521121|SUPERIORITY|||||||0.1318|||||||Wilcoxon (Mann-Whitney)|||||||0.1318
72495796|NCT02105415|144521149|SUPERIORITY||Mean Difference (Final Values)|-2.1||||0.385|TWO_SIDED|95.0|-6.9|2.7|||ANCOVA|||5 minutes||2.7|-6.9|0.385
72495797|NCT02105415|144521149|SUPERIORITY||Mean Difference (Final Values)|-4.0||||0.241|TWO_SIDED|95.0|-10.8|2.8|||ANCOVA|||10 minutes||2.8|-10.8|0.241
72559045|NCT01243151|144647858|SUPERIORITY_OR_OTHER||LS Mean Difference|-26.35|STANDARD_ERROR_OF_MEAN|4.315|<|0.0001|TWO_SIDED|95.0|-34.92|-17.79|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-17.79|-34.92|<0.0001
72439832|NCT02528188|144393178|SUPERIORITY||LS Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.13||0.1873|TWO_SIDED|95.0|-0.43|0.08|||ANCOVA|||Week 48: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.||0.08|-0.43|0.1873
72439833|NCT02528188|144393178|SUPERIORITY||LS Mean Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.13||0.5719|TWO_SIDED|95.0|-0.33|0.18|||ANCOVA|||Week 48: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.||0.18|-0.33|0.5719
72439834|NCT02528188|144393178|SUPERIORITY||LS Mean Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.13||0.3571|TWO_SIDED|95.0|-0.39|0.14|||ANCOVA|||Week 56: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.||0.14|-0.39|0.3571
72495798|NCT02105415|144521149|SUPERIORITY||Mean Difference (Final Values)|-0.8||||0.802|TWO_SIDED|95.0|-7.2|5.6|||ANCOVA|||15 minutes||5.6|-7.2|0.802
72495799|NCT02105415|144521150|SUPERIORITY|||||||0.605|||||||ANCOVA|||||||0.605
72495800|NCT02105415|144521151|SUPERIORITY|||||||0.212|||||||ANCOVA|||Pre-treatment||||0.212
72495801|NCT02105415|144521151|SUPERIORITY|||||||0.308|||||||ANCOVA|||New-onset pressors (within 3 minutes)||||0.308
72495802|NCT02105415|144521151|SUPERIORITY|||||||0.691|||||||ANCOVA|||Delayed-onset pressors (within 24 hrs)||||0.691
72495803|NCT02105415|144521153|SUPERIORITY|||||||0.911|||||||ANCOVA|||||||0.911
72495804|NCT02105415|144521154|SUPERIORITY|||||||0.069|||||||ANCOVA|||Red blood cell||||0.069
72495805|NCT02105415|144521154|SUPERIORITY|||||||0.046|||||||ANCOVA|||Non-red blood cell||||0.046
72495806|NCT02105415|144521154|SUPERIORITY|||||||0.502|||||||ANCOVA|||Colloid||||0.502
72495807|NCT02105415|144521155|SUPERIORITY|||||||0.994|||||||ANCOVA|||||||0.994
72495808|NCT02105415|144521156|SUPERIORITY|||||||0.233|||||||ANCOVA|||||||0.233
72495809|NCT01116544|144521191|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.005|TWO_SIDED|||||A priori threshold = 0.05|Wilcoxon (Mann-Whitney)|||||||<0.005
72495810|NCT01116544|144521192|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Power analysis called for sample sizes of 32 participants in each treatment group. The study was close before reaching this number of participants.|||||<|0.001||||||Hypothesis: significant increase in score (post-tx - pre-tx) for both groups|ANCOVA|FMA scores adjusted for baseline differences.||||||<0.001
72495811|NCT01116544|144521193|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|TWO_SIDED|||||Across both groups, whether score increased following completion of intervention|ANCOVA|||||||0.001
72495812|NCT01116544|144521194|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001||||||Across both treatment groups|ANCOVA|||||||0.001
72495813|NCT01116544|144521195|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Data combined between 2 treatment groups||||0.001
72495814|NCT01116544|144521196|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||Both treatment groups combined||||>0.05
72495815|NCT02288273|144521219|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Mixed Models Analysis|||||||<0.001
72495816|NCT02419508|144521228|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||< 0.001
72495817|NCT02419508|144521229|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
72439835|NCT02528188|144393178|SUPERIORITY||LS Mean Difference|0.02|STANDARD_ERROR_OF_MEAN|0.14||0.9072|TWO_SIDED|95.0|-0.25|0.28|||ANCOVA|||Week 56: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.||0.28|-0.25|0.9072
72559046|NCT01243151|144647858|SUPERIORITY_OR_OTHER||LS Mean Difference|-35.89|STANDARD_ERROR_OF_MEAN|4.318|<|0.0001|TWO_SIDED|95.0|-44.46|-27.33|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-27.33|-44.46|<0.0001
72439836|NCT02528188|144393180|SUPERIORITY||LS Mean Difference|-0.31|STANDARD_ERROR_OF_MEAN|0.09||0.0004|TWO_SIDED|95.0|-0.49|-0.14|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC stiffness subscale and baseline diary average pain as covariates, and study site as a random effect.||-0.14|-0.49|0.0004
72439837|NCT02528188|144393180|SUPERIORITY||LS Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.09||0.0134|TWO_SIDED|95.0|-0.4|-0.05|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC stiffness subscale and baseline diary average pain as covariates, and study site as a random effect.||-0.05|-0.40|0.0134
72439838|NCT02528188|144393180|SUPERIORITY||LS Mean Difference|-0.38|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001|TWO_SIDED|95.0|-0.56|-0.19|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC stiffness subscale and baseline diary average pain as covariates, and study site as a random effect.||-0.19|-0.56|<0.0001
72439839|NCT02528188|144393180|SUPERIORITY||LS Mean Difference|-0.48|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001|TWO_SIDED|95.0|-0.67|-0.29|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC stiffness subscale and baseline diary average pain as covariates, and study site as a random effect.||-0.29|-0.67|<0.0001
72439840|NCT02528188|144393180|SUPERIORITY||LS Mean Difference|-0.29|STANDARD_ERROR_OF_MEAN|0.1||0.0031|TWO_SIDED|95.0|-0.49|-0.1|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC stiffness subscale and baseline diary average pain as covariates, and study site as a random effect.||-0.10|-0.49|0.0031
72439841|NCT02528188|144393180|SUPERIORITY||LS Mean Difference|-0.63|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001|TWO_SIDED|95.0|-0.82|-0.43|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC stiffness subscale and baseline diary average pain as covariates, and study site as a random effect.||-0.43|-0.82|<0.0001
72439842|NCT02528188|144393180|SUPERIORITY||LS Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.11||0.0425|TWO_SIDED|95.0|-0.43|-0.01|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC stiffness subscale and baseline diary average pain as covariates, and study site as a random effect.||-0.01|-0.43|0.0425
72495818|NCT02419508|144521230|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
72495819|NCT02419508|144521231|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
72495820|NCT02419508|144521232|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
72495821|NCT02419508|144521233|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
72559047|NCT01243151|144647858|SUPERIORITY_OR_OTHER||LS Mean Difference|-34.23|STANDARD_ERROR_OF_MEAN|4.207|<|0.0001|TWO_SIDED|95.0|-42.58|-25.88|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-25.88|-42.58|<0.0001
72495822|NCT02419508|144521234|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
72495823|NCT02851173|144521240|OTHER|||||||0.79|||||||ANOVA|||The contrast of interest was the Time x Treatment Group interaction. CU group.||||0.79
72495824|NCT02851173|144521240|OTHER|||||||0.87|||||||ANOVA|||The contrast of interest was the Time x Treatment Group interaction. MCI group.||||0.87
72495825|NCT02851173|144521240|OTHER|||||||0.16|||||||ANOVA|||The contrast of interest was the Time x Treatment Group interaction. CU group. 3 outliers removed, whose scores were outside 1.5 times the interquartile range.||||0.16
72495826|NCT02851173|144521241|OTHER|||||||0.22|||||||ANOVA|||The contrast of interest was the Time x Treatment Group interaction. Left middle frontal gyrus 1.||||0.22
72495827|NCT02851173|144521241|OTHER|||||||0.69|||||||ANOVA|||The contrast of interest was the Time x Treatment Group interaction. Left medial frontal/superior frontal gyrus.||||0.69
72495828|NCT02851173|144521241|OTHER|||||||0.25|||||||ANOVA|||The contrast of interest was the Time x Treatment Group interaction. Right superior parietal lobule.||||0.25
72495829|NCT02851173|144521241|OTHER|||||||0.86|||||||ANOVA|||The contrast of interest was the Time x Treatment Group interaction. Left inferior parietal lobule.||||0.86
72439843|NCT02528188|144393180|SUPERIORITY||LS Mean Difference|-0.44|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001|TWO_SIDED|95.0|-0.65|-0.23|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC stiffness subscale and baseline diary average pain as covariates, and study site as a random effect.||-0.23|-0.65|<0.0001
72439844|NCT02528188|144393180|SUPERIORITY||LS Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.13||0.298|TWO_SIDED|95.0|-0.4|0.12|||ANCOVA|||Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC stiffness subscale and baseline diary average pain as covariates, and study site as a random effect.||0.12|-0.40|0.2980
72439845|NCT02528188|144393180|SUPERIORITY||LS Mean Difference|-0.32|STANDARD_ERROR_OF_MEAN|0.13||0.0179|TWO_SIDED|95.0|-0.58|-0.05|||ANCOVA|||Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC stiffness subscale and baseline diary average pain as covariates, and study site as a random effect.||-0.05|-0.58|0.0179
72439846|NCT02528188|144393180|SUPERIORITY||LS Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.13||0.2328|TWO_SIDED|95.0|-0.42|0.1|||ANCOVA|||Week 32: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC stiffness subscale and baseline diary average pain as covariates, and study site as a random effect.||0.10|-0.42|0.2328
72439847|NCT02528188|144393180|SUPERIORITY||LS Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.14||0.1019|TWO_SIDED|95.0|-0.49|0.04|||ANCOVA|||Week 32: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC stiffness subscale and baseline diary average pain as covariates, and study site as a random effect.||0.04|-0.49|0.1019
72439848|NCT02528188|144393180|SUPERIORITY||LS Mean Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.14||0.4002|TWO_SIDED|95.0|-0.38|0.15|||ANCOVA|||Week 40: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC stiffness subscale and baseline diary average pain as covariates, and study site as a random effect.||0.15|-0.38|0.4002
72439849|NCT02528188|144393180|SUPERIORITY||LS Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.14||0.2149|TWO_SIDED|95.0|-0.45|0.1|||ANCOVA|||Week 40: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC stiffness subscale and baseline diary average pain as covariates, and study site as a random effect.||0.10|-0.45|0.2149
72439850|NCT02528188|144393180|SUPERIORITY||LS Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.14||0.2442|TWO_SIDED|95.0|-0.43|0.11|||ANCOVA|||Week 48: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC stiffness subscale and baseline diary average pain as covariates, and study site as a random effect.||0.11|-0.43|0.2442
72559048|NCT01243151|144647858|SUPERIORITY_OR_OTHER||LS Mean Difference|-33.96|STANDARD_ERROR_OF_MEAN|4.246|<|0.0001|TWO_SIDED|95.0|-42.39|-25.53|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-25.53|-42.39|<0.0001
72439851|NCT02528188|144393180|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.14||0.4609|TWO_SIDED|95.0|-0.37|0.17|||ANCOVA|||Week 48: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC stiffness subscale and baseline diary average pain as covariates, and study site as a random effect.||0.17|-0.37|0.4609
72439852|NCT02528188|144393180|SUPERIORITY||LS Mean Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.14||0.8129|TWO_SIDED|95.0|-0.31|0.24|||ANCOVA|||Week 56: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC stiffness subscale and baseline diary average pain as covariates, and study site as a random effect.||0.24|-0.31|0.8129
72439853|NCT02528188|144393180|SUPERIORITY||LS Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.14||0.7883|TWO_SIDED|95.0|-0.32|0.24|||ANCOVA|||Week 56: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC stiffness subscale and baseline diary average pain as covariates, and study site as a random effect.||0.24|-0.32|0.7883
72559049|NCT01243151|144647858|SUPERIORITY_OR_OTHER||LS Mean Difference|-35.41|STANDARD_ERROR_OF_MEAN|4.315|<|0.0001|TWO_SIDED|95.0|-43.98|-26.85|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-26.85|-43.98|<0.0001
72559050|NCT01243151|144647858|SUPERIORITY_OR_OTHER||LS Mean Difference|-43.28|STANDARD_ERROR_OF_MEAN|4.318|<|0.0001|TWO_SIDED|95.0|-51.85|-34.71|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-34.71|-51.85|<0.0001
72439854|NCT02528188|144393182|SUPERIORITY||LS Mean Difference|-0.21|STANDARD_ERROR_OF_MEAN|0.08||0.0119|TWO_SIDED|95.0|-0.37|-0.05|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC average score and baseline diary average pain as covariates, and study site as a random effect.||-0.05|-0.37|0.0119
72439855|NCT02528188|144393182|SUPERIORITY||LS Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.08||0.3073|TWO_SIDED|95.0|-0.24|0.08|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC average score and baseline diary average pain as covariates, and study site as a random effect.||0.08|-0.24|0.3073
72439856|NCT02528188|144393182|SUPERIORITY||LS Mean Difference|-0.33|STANDARD_ERROR_OF_MEAN|0.09||0.0002|TWO_SIDED|95.0|-0.5|-0.15|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC average score and baseline diary average pain as covariates, and study site as a random effect.||-0.15|-0.50|0.0002
72439857|NCT02528188|144393182|SUPERIORITY||LS Mean Difference|-0.39|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001|TWO_SIDED|95.0|-0.56|-0.22|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC average score and baseline diary average pain as covariates, and study site as a random effect.||-0.22|-0.56|<0.0001
72439858|NCT02528188|144393182|SUPERIORITY||LS Mean Difference|-0.21|STANDARD_ERROR_OF_MEAN|0.09||0.0251|TWO_SIDED|95.0|-0.39|-0.03|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC average score and baseline diary average pain as covariates, and study site as a random effect.||-0.03|-0.39|0.0251
72439859|NCT02528188|144393182|SUPERIORITY||LS Mean Difference|-0.48|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001|TWO_SIDED|95.0|-0.66|-0.3|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC average score and baseline diary average pain as covariates, and study site as a random effect.||-0.30|-0.66|<0.0001
72439860|NCT02528188|144393182|SUPERIORITY||LS Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.1||0.0625|TWO_SIDED|95.0|-0.39|0.01|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC average score and baseline diary average pain as covariates, and study site as a random effect.||0.01|-0.39|0.0625
72439861|NCT02528188|144393182|SUPERIORITY||LS Mean Difference|-0.34|STANDARD_ERROR_OF_MEAN|0.1||0.001|TWO_SIDED|95.0|-0.54|-0.14|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC average score and baseline diary average pain as covariates, and study site as a random effect.||-0.14|-0.54|0.0010
72439862|NCT02528188|144393182|SUPERIORITY||LS Mean Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.13||0.4005|TWO_SIDED|95.0|-0.36|0.14|||ANCOVA|||Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC average score and baseline diary average pain as covariates, and study site as a random effect.||0.14|-0.36|0.4005
72439863|NCT02528188|144393182|SUPERIORITY||LS Mean Difference|-0.25|STANDARD_ERROR_OF_MEAN|0.13||0.053|TWO_SIDED|95.0|-0.5|0.0|||ANCOVA|||Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC average score and baseline diary average pain as covariates, and study site as a random effect.||0.00|-0.50|0.0530
72439864|NCT02528188|144393182|SUPERIORITY||LS Mean Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.13||0.4074|TWO_SIDED|95.0|-0.37|0.15|||ANCOVA|||Week 32: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC average score and baseline diary average pain as covariates, and study site as a random effect.||0.15|-0.37|0.4074
72495830|NCT02851173|144521241|OTHER|||||||0.28|||||||ANOVA|||The contrast of interest was the Time x Treatment Group interaction. Left middle frontal gyrus 2.||||0.28
72495831|NCT02851173|144521241|OTHER|||||||0.12|||||||ANOVA|||The contrast of interest was the Time x Treatment Group interaction. Right superior frontal gyrus.||||0.12
72495832|NCT02851173|144521241|OTHER|||||||0.26|||||||ANOVA|||The contrast of interest was the Time x Treatment Group interaction. Right middle frontal gyrus.||||0.26
72559051|NCT01243151|144647858|SUPERIORITY_OR_OTHER||LS Mean Difference|-38.0|STANDARD_ERROR_OF_MEAN|4.207|<|0.0001|TWO_SIDED|95.0|-46.35|-29.65|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-29.65|-46.35|<0.0001
72559052|NCT01243151|144647858|SUPERIORITY_OR_OTHER||LS Mean Difference|-29.77|STANDARD_ERROR_OF_MEAN|4.246|<|0.0001|TWO_SIDED|95.0|-38.19|-21.34|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-21.34|-38.19|<0.0001
72495833|NCT02851173|144521241|OTHER|||||||0.83|||||||ANOVA|||The contract of interest was the Time x Treatment Group interaction. Right inferior frontal gyrus.||||0.83
72559053|NCT01243151|144647858|SUPERIORITY_OR_OTHER||LS Mean Difference|-31.22|STANDARD_ERROR_OF_MEAN|4.315|<|0.0001|TWO_SIDED|95.0|-39.79|-22.65|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-22.65|-39.79|<0.0001
72439865|NCT02528188|144393182|SUPERIORITY||LS Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.13||0.2629|TWO_SIDED|95.0|-0.41|0.11|||ANCOVA|||Week 32: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC average score and baseline diary average pain as covariates, and study site as a random effect.||0.11|-0.41|0.2629
72439866|NCT02528188|144393182|SUPERIORITY||LS Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.13||0.5582|TWO_SIDED|95.0|-0.34|0.18|||ANCOVA|||Week 40: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC average score and baseline diary average pain as covariates, and study site as a random effect.||0.18|-0.34|0.5582
72439867|NCT02528188|144393182|SUPERIORITY||LS Mean Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.13||0.4907|TWO_SIDED|95.0|-0.35|0.17|||ANCOVA|||Week 40: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC average score and baseline diary average pain as covariates, and study site as a random effect.||0.17|-0.35|0.4907
72439868|NCT02528188|144393182|SUPERIORITY||LS Mean Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.14||0.4043|TWO_SIDED|95.0|-0.38|0.15|||ANCOVA|||Week 48: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC average score and baseline diary average pain as covariates, and study site as a random effect.||0.15|-0.38|0.4043
72439869|NCT02528188|144393182|SUPERIORITY||LS Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.14||0.7663|TWO_SIDED|95.0|-0.31|0.23|||ANCOVA|||Week 48: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC average score and baseline diary average pain as covariates, and study site as a random effect.||0.23|-0.31|0.7663
72439870|NCT02528188|144393182|SUPERIORITY||LS Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.14||0.7415|TWO_SIDED|95.0|-0.31|0.22|||ANCOVA|||Week 56: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC average score and baseline diary average pain as covariates, and study site as a random effect.||0.22|-0.31|0.7415
72439871|NCT02528188|144393182|SUPERIORITY||LS Mean Difference|0.02|STANDARD_ERROR_OF_MEAN|0.13||0.8688|TWO_SIDED|95.0|-0.24|0.29|||ANCOVA|||Week 56: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC average score and baseline diary average pain as covariates, and study site as a random effect.||0.29|-0.24|0.8688
72439872|NCT02528188|144393184|SUPERIORITY||LS Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.09||0.3622|TWO_SIDED|95.0|-0.25|0.09|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.||0.09|-0.25|0.3622
72495834|NCT02851173|144521241|OTHER|||||||0.55|||||||ANOVA|||The contrast of interest was the Time x Treatment Group interaction. In this sub-group analysis, we performed a sub-population analysis (N=36), including only participants who performed the 2Back task to criterion (\>50% accuracy). Left middle frontal gyrus 1.||||0.55
72495835|NCT02851173|144521241|OTHER|||||||0.76|||||||ANOVA|||The contrast of interest was the Time x Treatment Group interaction. In this sub-group analysis, we performed a sub-population analysis (N=36), including only participants who performed the 2Back task to criterion (\>50% accuracy). Left medial frontal/superior frontal gyrus.||||0.76
72495836|NCT02851173|144521241|OTHER|||||||0.38|||||||ANOVA|||The contrast of interest was the Time x Treatment Group interaction. In this sub-group analysis, we performed a sub-population analysis (N=36), including only participants who performed the 2Back task to criterion (\>50% accuracy). Right superior parietal lobule.||||0.38
72559054|NCT01243151|144647858|SUPERIORITY_OR_OTHER||LS Mean Difference|-41.34|STANDARD_ERROR_OF_MEAN|4.318|<|0.0001|TWO_SIDED|95.0|-49.91|-32.78|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-32.78|-49.91|<0.0001
72495837|NCT02851173|144521241|OTHER|||||||0.93|||||||ANOVA|||The contrast of interest was the Time x Treatment Group interaction. In this sub-group analysis, we performed a sub-population analysis (N=36), including only participants who performed the 2Back task to criterion (\>50% accuracy). Left inferior parietal lobule.||||0.93
72559055|NCT01243151|144647858|SUPERIORITY_OR_OTHER||LS Mean Difference|-36.04|STANDARD_ERROR_OF_MEAN|4.207|<|0.0001|TWO_SIDED|95.0|-44.39|-27.69|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-27.69|-44.39|<0.0001
72559056|NCT01243151|144647859|SUPERIORITY_OR_OTHER||LS Mean Difference|4.44|STANDARD_ERROR_OF_MEAN|3.975||0.269|TWO_SIDED|95.0|-3.53|12.41|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||12.41|-3.53|0.2690
72559057|NCT01243151|144647859|SUPERIORITY_OR_OTHER||LS Mean Difference|5.22|STANDARD_ERROR_OF_MEAN|4.133||0.2122|TWO_SIDED|95.0|-3.07|13.5|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||13.50|-3.07|0.2122
72439873|NCT02528188|144393184|SUPERIORITY||LS Mean Difference|0.07|STANDARD_ERROR_OF_MEAN|0.09||0.3894|TWO_SIDED|95.0|-0.09|0.24|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.||0.24|-0.09|0.3894
72439874|NCT02528188|144393184|SUPERIORITY||LS Mean Difference|-0.23|STANDARD_ERROR_OF_MEAN|0.09||0.0137|TWO_SIDED|95.0|-0.42|-0.05|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.||-0.05|-0.42|0.0137
72439875|NCT02528188|144393184|SUPERIORITY||LS Mean Difference|-0.24|STANDARD_ERROR_OF_MEAN|0.09||0.0106|TWO_SIDED|95.0|-0.43|-0.06|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.||-0.06|-0.43|0.0106
72439876|NCT02528188|144393184|SUPERIORITY||LS Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.1||0.7179|TWO_SIDED|95.0|-0.23|0.16|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.||0.16|-0.23|0.7179
72439877|NCT02528188|144393184|SUPERIORITY||LS Mean Difference|-0.25|STANDARD_ERROR_OF_MEAN|0.1||0.012|TWO_SIDED|95.0|-0.44|-0.05|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.||-0.05|-0.44|0.0120
72439878|NCT02528188|144393184|SUPERIORITY||LS Mean Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.11||0.5372|TWO_SIDED|95.0|-0.28|0.15|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.||0.15|-0.28|0.5372
72439879|NCT02528188|144393184|SUPERIORITY||LS Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.11||0.0899|TWO_SIDED|95.0|-0.4|0.03|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.||0.03|-0.40|0.0899
72439880|NCT02528188|144393184|SUPERIORITY||LS Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.13||0.7646|TWO_SIDED|95.0|-0.3|0.22|||ANCOVA|||Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.||0.22|-0.30|0.7646
72439881|NCT02528188|144393184|SUPERIORITY||LS Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.13||0.2547|TWO_SIDED|95.0|-0.41|0.11|||ANCOVA|||Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.||0.11|-0.41|0.2547
72439882|NCT02528188|144393184|SUPERIORITY||LS Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.14||0.8806|TWO_SIDED|95.0|-0.29|0.25|||ANCOVA|||Week 32: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.||0.25|-0.29|0.8806
72439883|NCT02528188|144393184|SUPERIORITY||LS Mean Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.14||0.8416|TWO_SIDED|95.0|-0.3|0.24|||ANCOVA|||Week 32: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.||0.24|-0.30|0.8416
72559058|NCT01243151|144647859|SUPERIORITY_OR_OTHER||LS Mean Difference|0.54|STANDARD_ERROR_OF_MEAN|4.054||0.8953|TWO_SIDED|95.0|-7.59|8.67|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||8.67|-7.59|0.8953
72559059|NCT01243151|144647859|SUPERIORITY_OR_OTHER||LS Mean Difference|5.59|STANDARD_ERROR_OF_MEAN|4.045||0.1723|TWO_SIDED|95.0|-2.51|13.7|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||13.70|-2.51|0.1723
72495838|NCT02851173|144521241|OTHER|||||||0.41|||||||ANOVA|||The contrast of interest was the Time x Treatment Group interaction. In this sub-group analysis, we performed a sub-population analysis (N=36), including only participants who performed the 2Back task to criterion (\>50% accuracy). Left middle frontal gyrus 2.||||0.41
72495839|NCT02851173|144521241|OTHER|||||||0.06|||||||ANOVA|||The contrast of interest was the Time x Treatment Group interaction. In this sub-group analysis, we performed a sub-population analysis (N=36), including only participants who performed the 2Back task to criterion (\>50% accuracy). Right superior frontal gyrus.||||0.06
72387379|NCT02400333|144283249|SUPERIORITY_OR_OTHER||Geometric mean ratio|94.4|||||TWO_SIDED|95.0|90.26|98.73||||||Statistical assessment of ticagrelor relative bioavailability following ticagrelor OD tablets suspended in water and administered through NG tube compared to ticagrelor IR tablets.||98.73|90.26|
72387380|NCT02400333|144283249|SUPERIORITY_OR_OTHER||Geometric mean ratio|94.82|||||TWO_SIDED|95.0|91.36|98.42||||||Statistical assessment of metabolite AR-C124910XX relative bioavailability following ticagrelor OD tablets administered with water compared to ticagrelor IR tablets.||98.42|91.36|
72387381|NCT02400333|144283249|SUPERIORITY_OR_OTHER||Geometric mean ratio|95.71|||||TWO_SIDED|95.0|91.78|99.82||||||Statistical assessment of metabolite AR-C124910XX relative bioavailability following ticagrelor OD tablets administered without water compared to ticagrelor IR tablets.||99.82|91.78|
72387382|NCT02400333|144283249|SUPERIORITY_OR_OTHER||Geometric mean ratio|96.5|||||TWO_SIDED|95.0|93.26|99.87||||||Statistical assessment of metabolite AR-C124910XX relative bioavailability following ticagrelor OD tablets suspended in water and administered through NG tube compared to ticagrelor IR tablets.||99.87|93.26|
72387383|NCT01332500|144283272|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Triptan tablets|paired t-test 2-sided|||||||<0.001
72387384|NCT01332500|144283272|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Non-steroidal anti-inflammatory drug tablets|paired t-test 2-sided|||||||<0.001
72387385|NCT01332500|144283272|SUPERIORITY_OR_OTHER|||||||0.005||95.0||||Opioid tablets|paired t-test 2-sided|||||||0.005
72387386|NCT01332500|144283272|SUPERIORITY_OR_OTHER|||||||0.336||95.0||||Ergot tablets|paired t-test 2-sided|||||||0.336
72387387|NCT01332500|144283272|SUPERIORITY_OR_OTHER|||||||0.162||95.0||||Other tablets|paired t-test 2-sided|||||||0.162
72387388|NCT01332500|144283273|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Triptan health plan costs|paired t-test 2-sided|||||||<0.001
72387389|NCT01332500|144283273|SUPERIORITY_OR_OTHER|||||||0.349||95.0||||Non-steroidal anti-inflammatory drug health plan costs|paired t-test 2-sided|||||||0.349
72387390|NCT01332500|144283273|SUPERIORITY_OR_OTHER|||||||0.208||95.0||||Opioid health plan costs|paired t-test 2-sided|||||||0.208
72387391|NCT01332500|144283273|SUPERIORITY_OR_OTHER|||||||0.239||95.0||||Ergot health plan costs|paired t-test 2-sided|||||||0.239
72387392|NCT01332500|144283273|SUPERIORITY_OR_OTHER|||||||0.583||95.0||||Other health plan costs|paired t-test 2-sided|||||||0.583
72387393|NCT01332500|144283273|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Total heath plan costs|paired t-test 2-sided|||||||<0.001
72387394|NCT01332500|144283274|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Triptan health plus copay costs|paired t-test 2-sided|||||||<0.001
72387395|NCT01332500|144283274|SUPERIORITY_OR_OTHER|||||||0.177||95.0||||Non-steroidal, anti-inflammatory drug health plus copay costs|paired t-test 2-sided|||||||0.177
72387396|NCT01332500|144283274|SUPERIORITY_OR_OTHER|||||||0.173||95.0||||Opioid health plus copay costs|paired t-test 2-sided|||||||0.173
72387397|NCT01332500|144283274|SUPERIORITY_OR_OTHER|||||||0.191||95.0||||Ergot health plus copay costs|paired t-test 2-sided|||||||0.191
72387398|NCT01332500|144283274|SUPERIORITY_OR_OTHER|||||||0.254||95.0||||Other health plus copay costs|paired t-test 2-sided|||||||0.254
72387399|NCT01332500|144283274|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Total health plus copay costs|paired t-test 2-sided|||||||<0.001
72387400|NCT01332500|144283275|SUPERIORITY_OR_OTHER|||||||0.866||95.0||||Triptan tablets|paired t-test 2-sided|||||||0.866
72387401|NCT01332500|144283275|SUPERIORITY_OR_OTHER|||||||0.094||95.0||||Non-steroidal anti-inflammatory drug tablets|paired t-test 2-sided|||||||0.094
72387402|NCT01332500|144283275|SUPERIORITY_OR_OTHER|||||||0.832||95.0||||Opioid tablets|paired t-test 2-sided|||||||0.832
72387403|NCT01332500|144283275|SUPERIORITY_OR_OTHER|||||||0.392||95.0||||Ergot tablets|paired t-test 2-sided|||||||0.392
72387404|NCT01332500|144283275|SUPERIORITY_OR_OTHER|||||||0.752||95.0||||Other tablets|paired t-test 2-sided|||||||0.752
72387405|NCT01332500|144283276|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Triptan health plan costs|paired t-test 2-sided|||||||<0.001
72387406|NCT01332500|144283276|SUPERIORITY_OR_OTHER|||||||0.054||95.0||||Non-steroidal anti-inflammatory drug health plan costs|paired t-test 2-sided|||||||0.054
72387407|NCT01332500|144283276|SUPERIORITY_OR_OTHER|||||||0.59||95.0||||Opioid health plan costs|paired t-test 2-sided|||||||0.590
72387408|NCT01332500|144283276|SUPERIORITY_OR_OTHER|||||||0.382||95.0||||Ergot health plan costs|paired t-test 2-sided|||||||0.382
72387409|NCT01332500|144283276|SUPERIORITY_OR_OTHER|||||||0.343||95.0||||Other health plan costs|paired t-test 2-sided|||||||0.343
72387410|NCT01332500|144283276|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Total health plan costs|paired t-test 2-sided|||||||<0.001
72387411|NCT01332500|144283277|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Triptan health plus copay costs|paired t-test 2-sided|||||||<0.001
72387412|NCT01332500|144283277|SUPERIORITY_OR_OTHER|||||||0.146||95.0||||Non-steroidal anti-inflammatory drug health plus copay costs|paired t-test 2-sided|||||||0.146
72387413|NCT01332500|144283277|SUPERIORITY_OR_OTHER|||||||0.826||95.0||||Opioid health plus copay costs|paired t-test 2-sided|||||||0.826
72387414|NCT01332500|144283277|SUPERIORITY_OR_OTHER|||||||0.354||95.0||||Ergot health plus copay costs|paired t-test 2-sided|||||||0.354
72387415|NCT01332500|144283277|SUPERIORITY_OR_OTHER|||||||0.514||95.0||||Other health plus copay costs|paired t-test 2-sided|||||||0.514
72387416|NCT01332500|144283277|SUPERIORITY_OR_OTHER|||||||0.001||95.0||||Total health plus copay costs|paired t-test 2-sided|||||||0.001
72495840|NCT02851173|144521241|OTHER|||||||0.18|||||||ANOVA|||The contrast of interest was the Time x Treatment Group interaction. In this sub-group analysis, we performed a sub-population analysis (N=36), including only participants who performed the 2Back task to criterion (\>50% accuracy). Right middle frontal gyrus.||||0.18
72495841|NCT02851173|144521241|OTHER|||||||0.84|||||||ANOVA|||The contrast of interest was the Time x Treatment Group interaction. In this sub-group analysis, we performed a sub-population analysis (N=36), including only participants who performed the 2Back task to criterion (\>50% accuracy). Right inferior frontal gyrus.||||0.84
72439884|NCT02528188|144393184|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.14||0.9981|TWO_SIDED|95.0|-0.28|0.28|||ANCOVA|||Week 40: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.||0.28|-0.28|0.9981
72439885|NCT02528188|144393184|SUPERIORITY||LS Mean Difference|0.06|STANDARD_ERROR_OF_MEAN|0.14||0.6485|TWO_SIDED|95.0|-0.21|0.34|||ANCOVA|||Week 40: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.||0.34|-0.21|0.6485
72439886|NCT02528188|144393184|SUPERIORITY||LS Mean Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.14||0.8317|TWO_SIDED|95.0|-0.3|0.24|||ANCOVA|||Week 48: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.||0.24|-0.30|0.8317
72439887|NCT02528188|144393184|SUPERIORITY||LS Mean Difference|0.08|STANDARD_ERROR_OF_MEAN|0.14||0.5819|TWO_SIDED|95.0|-0.19|0.35|||ANCOVA|||Week 48: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.||0.35|-0.19|0.5819
72439888|NCT02528188|144393184|SUPERIORITY||LS Mean Difference|0.03|STANDARD_ERROR_OF_MEAN|0.14||0.8538|TWO_SIDED|95.0|-0.26|0.31|||ANCOVA|||Week 56: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.||0.31|-0.26|0.8538
72439889|NCT02528188|144393184|SUPERIORITY||LS Mean Difference|0.19|STANDARD_ERROR_OF_MEAN|0.15||0.1981|TWO_SIDED|95.0|-0.1|0.47|||ANCOVA|||Week 56: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.||0.47|-0.10|0.1981
72439890|NCT02528188|144393186|SUPERIORITY||LS Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.09||0.0846|TWO_SIDED|95.0|-0.33|0.02|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.||0.02|-0.33|0.0846
72439891|NCT02528188|144393186|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.09||0.9749|TWO_SIDED|95.0|-0.18|0.17|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.||0.17|-0.18|0.9749
72439892|NCT02528188|144393186|SUPERIORITY||LS Mean Difference|-0.26|STANDARD_ERROR_OF_MEAN|0.1||0.0076|TWO_SIDED|95.0|-0.45|-0.07|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.||-0.07|-0.45|0.0076
72439893|NCT02528188|144393186|SUPERIORITY||LS Mean Difference|-0.35|STANDARD_ERROR_OF_MEAN|0.1||0.0003|TWO_SIDED|95.0|-0.54|-0.16|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.||-0.16|-0.54|0.0003
72495842|NCT02851173|144521242|OTHER|||||||0.53|||||||ANOVA|||The contrast of interest was the Time x Treatment Group interaction.||||0.53
72495843|NCT02851173|144521242|OTHER|||||||0.74|||||||ANOVA|||The contrast of interest was the Time x Treatment Group interaction. In this sub-group analysis, we performed a sub-population analysis (N=36), including only participants who performed the 2Back task to criterion (\>50% accuracy).||||0.74
72495844|NCT02851173|144521243|OTHER|||||||0.72|||||||ANOVA|||The contrast of interest was the Time x Treatment Group interaction.||||0.72
72495845|NCT02851173|144521243|OTHER|||||||0.97|||||||ANOVA|||The contrast of interest was the Time x Treatment Group interaction. In this sub-group analysis, we performed a sub-population analysis (N=36), including only participants who performed the 2Back task to criterion (\>50% accuracy).||||0.97
72495846|NCT02554929|144521322|SUPERIORITY||Mean Difference (Final Values)|-0.08|STANDARD_ERROR_OF_MEAN|0.42||0.002|TWO_SIDED|95.0|-0.91|0.74||P value adjusted for multiple comparison; a priori threshold for statistical significance was 0.05.|Mixed Models Analysis||Values above are for the primary outcome measure of the Anxiety Disorders Interview Schedule for DSM-IV, Clinical Severity Rating (ADIS-CSR) score for SAD.|In our previous study, 42% participants in the CBT arm lost their primary diagnosis of social anxiety disorder (SAD) and/or selective mutism (SM) post-intervention versus none of the comparison group participants. In the present study, we conservatively estimated that 10% of comparison group children will lose their primary diagnosis. A sample size of 70 achieves a power of 81% to detect a 32% difference between treatments, using a two-sided Chi-squared test with a significance level of 0.05.||0.74|-0.91|0.002
72439894|NCT02528188|144393186|SUPERIORITY||LS Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.1||0.4402|TWO_SIDED|95.0|-0.27|0.12|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.||0.12|-0.27|0.4402
72439895|NCT02528188|144393186|SUPERIORITY||LS Mean Difference|-0.41|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001|TWO_SIDED|95.0|-0.61|-0.21|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.||-0.21|-0.61|<0.0001
72439896|NCT02528188|144393186|SUPERIORITY||LS Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.11||0.1543|TWO_SIDED|95.0|-0.38|0.06|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.||0.06|-0.38|0.1543
72439897|NCT02528188|144393186|SUPERIORITY||LS Mean Difference|-0.31|STANDARD_ERROR_OF_MEAN|0.11||0.0053|TWO_SIDED|95.0|-0.53|-0.09|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.||-0.09|-0.53|0.0053
72439898|NCT02528188|144393186|SUPERIORITY||LS Mean Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.14||0.6445|TWO_SIDED|95.0|-0.33|0.2|||ANCOVA|||Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.||0.20|-0.33|0.6445
72439899|NCT02528188|144393186|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.14||0.1439|TWO_SIDED|95.0|-0.47|0.07|||ANCOVA|||Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.||0.07|-0.47|0.1439
72439900|NCT02528188|144393186|SUPERIORITY||LS Mean Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.14||0.8402|TWO_SIDED|95.0|-0.3|0.25|||ANCOVA|||Week 32: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.||0.25|-0.30|0.8402
72439901|NCT02528188|144393186|SUPERIORITY||LS Mean Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.14||0.4439|TWO_SIDED|95.0|-0.38|0.17|||ANCOVA|||Week 32: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.||0.17|-0.38|0.4439
72495847|NCT02554929|144521322|SUPERIORITY||Mean Difference (Final Values)|0.27|STANDARD_ERROR_OF_MEAN|0.62||0.002|TWO_SIDED|95.0|-0.95|1.48||P value adjusted for multiple comparison; a priori threshold for statistical significance was 0.05.|Mixed Models Analysis||Values above are for the primary outcome measure of the Anxiety Disorders Interview Schedule for DSM-IV, Clinical Severity Rating (ADIS-CSR) score for SM.|In our previous study, 42% participants in the CBT arm lost their primary diagnosis of social anxiety disorder (SAD) and/or selective mutism (SM) post-intervention versus none of the comparison group participants. In the present study, we conservatively estimated that 10% of comparison group children will lose their primary diagnosis. A sample size of 70 achieves a power of 81% to detect a 32% difference between treatments, using a two-sided Chi-squared test with a significance level of 0.05.||1.48|-0.95|0.002
72495848|NCT02554929|144521325|SUPERIORITY||Mean Difference (Final Values)|1.89|STANDARD_ERROR_OF_MEAN|3.14||0.002|TWO_SIDED|95.0|-4.28|8.08||P value adjusted for multiple comparison; a priori threshold for statistical significance was 0.05.|Mixed Models Analysis||The estimated value of the estimation parameter corresponds to the difference between change in CGAS scores for participants in the CBT arm, in comparison to those in the socialization arm, from pre-treatment to 6-month follow-up.|In our previous study, 42% participants in the CBT arm lost their primary diagnosis of social anxiety disorder (SAD) and/or selective mutism (SM) post-intervention versus none of the comparison group participants. In the present study, we conservatively estimated that 10% of comparison group children will lose their primary diagnosis. A sample size of 70 achieves a power of 81% to detect a 32% difference between treatments, using a two-sided Chi-squared test with a significance level of 0.05.||8.08|-4.28|0.002
72495849|NCT00167245|144521369|SUPERIORITY|||||||0.01|||||||Chi-squared|||||||0.01
72495850|NCT00167245|144521370|SUPERIORITY_OR_OTHER_LEGACY|||||||0.45|||||||Generalized Estimating Equations|||||||0.45
72495851|NCT00167245|144521371|SUPERIORITY||Mean Difference (Final Values)|1.6||||0.4|TWO_SIDED|95.0|-2.1|5.2|||t-test, 2 sided|||||5.2|-2.1|0.4
72495852|NCT00804687|144521373|SUPERIORITY_OR_OTHER||Least Squares Mean difference|-0.126|STANDARD_ERROR_OF_MEAN|0.066||0.0602||95.0|-0.258|0.006|||Linear mixed model|||||0.006|-0.258|0.0602
72495853|NCT00804687|144521373|SUPERIORITY_OR_OTHER||Least Squares Mean difference|-0.195|STANDARD_ERROR_OF_MEAN|0.067||0.0043||95.0|-0.328|-0.063|||Linear mixed model|||||-0.063|-0.328|0.0043
72495854|NCT00804687|144521373|SUPERIORITY_OR_OTHER||Least Squares Mean difference|-0.066|STANDARD_ERROR_OF_MEAN|0.07||0.3513|TWO_SIDED|95.0|-0.206|0.075|||Linear mixed model|||||0.075|-0.206|0.3513
72495855|NCT00804687|144521374|SUPERIORITY_OR_OTHER||Least Squares Mean difference|8.604|STANDARD_ERROR_OF_MEAN|2.267||0.0003||95.0|4.104|13.104|||Linear mixed model|||||13.104|4.104|0.0003
72439902|NCT02528188|144393186|SUPERIORITY||LS Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.14||0.9376|TWO_SIDED|95.0|-0.27|0.29|||ANCOVA|||Week 40: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.||0.29|-0.27|0.9376
72439903|NCT02528188|144393186|SUPERIORITY||LS Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.14||0.7614|TWO_SIDED|95.0|-0.33|0.24|||ANCOVA|||Week 40: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.||0.24|-0.33|0.7614
72439904|NCT02528188|144393186|SUPERIORITY||LS Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.15||0.8081|TWO_SIDED|95.0|-0.32|0.25|||ANCOVA|||Week 48: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.||0.25|-0.32|0.8081
72439905|NCT02528188|144393186|SUPERIORITY||LS Mean Difference|0.04|STANDARD_ERROR_OF_MEAN|0.15||0.8078|TWO_SIDED|95.0|-0.25|0.33|||ANCOVA|||Week 48: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.||0.33|-0.25|0.8078
72439906|NCT02528188|144393186|SUPERIORITY||LS Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.15||0.9705|TWO_SIDED|95.0|-0.28|0.29|||ANCOVA|||Week 56: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.||0.29|-0.28|0.9705
72439907|NCT02528188|144393186|SUPERIORITY||LS Mean Difference|0.08|STANDARD_ERROR_OF_MEAN|0.15||0.5785|TWO_SIDED|95.0|-0.21|0.38|||ANCOVA|||Week 56: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.||0.38|-0.21|0.5785
72439908|NCT02528188|144393188|SUPERIORITY||LS Mean Difference|0.58|STANDARD_ERROR_OF_MEAN|0.74||0.4303|TWO_SIDED|95.0|-0.87|2.04|||ANCOVA|||Week 16: Percent Work Time Missed: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.||2.04|-0.87|0.4303
72439909|NCT02528188|144393188|SUPERIORITY||LS Mean Difference|-0.43|STANDARD_ERROR_OF_MEAN|0.75||0.5656|TWO_SIDED|95.0|-1.9|1.04|||ANCOVA|||Week 16: Percent Work Time Missed: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.||1.04|-1.90|0.5656
72439910|NCT02528188|144393188|SUPERIORITY||LS Mean Difference|0.03|STANDARD_ERROR_OF_MEAN|0.92||0.976|TWO_SIDED|95.0|-1.78|1.83|||ANCOVA|||Week 24: Percent Work Time Missed: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.||1.83|-1.78|0.9760
72439911|NCT02528188|144393188|SUPERIORITY||LS Mean Difference|0.53|STANDARD_ERROR_OF_MEAN|0.93||0.5678|TWO_SIDED|95.0|-1.3|2.36|||ANCOVA|||Week 24: Percent Work Time Missed: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.||2.36|-1.30|0.5678
72439912|NCT02528188|144393188|SUPERIORITY||LS Mean Difference|0.68|STANDARD_ERROR_OF_MEAN|1.76||0.6974|TWO_SIDED|95.0|-2.77|4.14|||ANCOVA|||Week 56: Percent Work Time Missed: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.||4.14|-2.77|0.6974
72439913|NCT02528188|144393188|SUPERIORITY||LS Mean Difference|2.64|STANDARD_ERROR_OF_MEAN|1.72||0.1261|TWO_SIDED|95.0|-0.75|6.04|||ANCOVA|||Week 56: Percent Work Time Missed: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.||6.04|-0.75|0.1261
72439914|NCT02528188|144393188|SUPERIORITY||LS Mean Difference|-1.48|STANDARD_ERROR_OF_MEAN|1.78||0.406|TWO_SIDED|95.0|-4.96|2.01|||ANCOVA|||Week 16: Percent Impairment While Working: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.||2.01|-4.96|0.4060
72495856|NCT00804687|144521374|SUPERIORITY_OR_OTHER||Least Squares Mean difference|4.699|STANDARD_ERROR_OF_MEAN|2.289||0.0428||95.0|0.155|9.243|||Linear mixed model|||||9.243|0.155|0.0428
72495857|NCT00804687|144521374|SUPERIORITY_OR_OTHER||Least Squares Mean difference|-3.905|STANDARD_ERROR_OF_MEAN|2.277||0.0895|TWO_SIDED|95.0|-8.424|0.614|||Linear mixed model|||||0.614|-8.424|0.0895
72495858|NCT03569202|144521377|SUPERIORITY||Mean Difference (Final Values)|1.8837||||0.662|TWO_SIDED|95.0|-6.7081|10.4756||A two-sided p-value less than 0.05 was considered statistically significant.|ANOVA|||Between-group comparison, change from baseline||10.4756|-6.7081|0.662
72387417|NCT02280304|144283279|SUPERIORITY||||||>|0.05||||||A priori threshold = voxel p\<.001, cluster p\<.05, FDR whole brain correction. There is no correction for multiple seeds given small sample sizes and pre-post design. To report NS p-values and associated z-scores, uncorrected cluster ps were queried.|t-test, 1 sided|||Z-scores represent Fisher transformed correlation coefficients representing the correlations between hypothesized regions. Positive values represents positive connectivity between regions. Negative values represent anticorrelations, or negative relations, between hypothesized regions.||||>0.05
72495859|NCT03569202|144521377|OTHER||Mean Difference (Final Values)|-24.6445|||<|0.0001|TWO_SIDED|95.0|-30.7199|-18.5692||A two-sided p-value less than 0.05 was considered statistically significant.|ANOVA|||Within-group change from baseline||-18.5692|-30.7199|<0.0001
72495860|NCT03569202|144521377|OTHER||Mean Difference (Final Values)|-26.5283|||<|0.0001|TWO_SIDED|95.0|-32.6036|-20.4529||A two-sided p-value less than 0.05 was considered statistically significant.|ANOVA|||Within-group change from baseline||-20.4529|-32.6036|<0.0001
72387418|NCT02280304|144283280|OTHER||Mean Difference (Net)|1.8|||||TWO_SIDED|||||||||||||
72387419|NCT02280304|144283280|OTHER||Cohen's d|0.35|||||TWO_SIDED||||||||Cohen's d reflects Extent of Participation subscale of the CRIS, Post - Pre|||||
72387420|NCT02280304|144283280|OTHER||Median Difference (Net)|0.8|||||TWO_SIDED|||||||||||||
72387421|NCT02280304|144283280|OTHER||Cohen's d|0.14|||||TWO_SIDED||||||||Cohen's d reflects Extent of Participation Scale of the Cris pre- post|||||
72387422|NCT02280304|144283280|OTHER||Median Difference (Net)|0.8|||||TWO_SIDED|||||||||||||
72387423|NCT02280304|144283280|OTHER||Cohen's d|0.2|||||TWO_SIDED||||||||Cohens d reflects the Cris pre post Perceived Limitations scale|||||
72387424|NCT02280304|144283280|OTHER||Mean Difference (Net)|1.8|||||TWO_SIDED|||||||||||||
72387425|NCT02280304|144283280|OTHER||Cohens d|0.53|||||TWO_SIDED|||||||||||||
72387426|NCT02280304|144283280|OTHER||Mean Difference (Net)|1.3|||||TWO_SIDED|||||||||||||
72387427|NCT02280304|144283280|OTHER||Cohens d|0.29|||||TWO_SIDED|||||||||||||
72387428|NCT02280304|144283280|OTHER||Mean Difference (Net)|0.6|||||TWO_SIDED|||||||||||||
72387429|NCT02280304|144283280|OTHER||Cohens d|0.13|||||TWO_SIDED|||||||||||||
72387430|NCT02280304|144283281|OTHER||Cohens d|0.86|||||TWO_SIDED||||||||Cohen's d effect size (Cohen's d=.20 small, Cohen's d=.50 medium, Cohen's d=.80 large)|Cohen's d effect sizes are reported for changes over time (0 weeks vs. 12 weeks) in each group separately.||||
72387431|NCT02280304|144283281|OTHER||Cohens d|0.3|||||TWO_SIDED||||||||Cohen's d effect size (Cohen's d=.20 small, Cohen's d=.50 medium, Cohen's d=.80 large)|Cohen's d effect sizes are reported for changes over time (0 weeks vs. 12 weeks) in each group separately.||||
72387432|NCT02280304|144283282|OTHER||Cohens d|1.32|||||TWO_SIDED||||||||Cohen's d effect size change (Cohen's d =0.20 is a small effect; Cohen's d=0.50 is a medium effect; Cohen's d=0.80 is a large effect.)|Cohen's d effect sizes are reported for changes over time (0 weeks vs. 12 weeks) in each group separately.||||
72387433|NCT02280304|144283282|OTHER||Cohens d|0.27|||||TWO_SIDED||||||||Cohen's d effect size (Cohen's d =0.20 is a small effect; Cohen's d=0.50 is a medium effect; Cohen's d=0.80 is a large effect.)|Cohen's d effect sizes are reported for changes over time (0 weeks vs. 12 weeks) in each group separately.||||
72387434|NCT02280304|144283283|SUPERIORITY||||||<|0.0099||||||The p-value obtained for the L PHG seed/L IPL cluster is 0.0099. The critical p-value after Bonferroni correction for multiple seeds is p=.008.|t-test, 2 sided|Significance is determined when clusters reach voxel threshold p\<.001, cluster p\<.05 FDR corrected for multiple comparisons across the whole brain.||||||<.0099
72387435|NCT02280304|144283283|SUPERIORITY||||||<|0.02||||||The p-value obtained for the L anterior PGH seed/left VMPC cluster is 0.02. The critical p-value after Bonferroni correction for six seeds is p=.008.|t-test, 2 sided|Significance is determined when clusters reach voxel threshold p\<.001, cluster p\<.05 FDR corrected for multiple comparisons across the whole brain.||||||<0.02
72387436|NCT02280304|144283284|OTHER||Slope|0.02|||<|3.8e-05|TWO_SIDED|||||Cluster in MPFC p\<0.000038 FDR corrected for multiple comparisons across whole brain. Bonferroni correction for multiple seeds p=0.008.|Regression, Linear|Significance is determined when voxel (height) threshold p=.001, cluster threshold p=.05, FDR corrected for multiple tests across the whole brain.||The extent of community participation prior to therapy was correlated with the functional connectivity of the right hippocampus seed after therapy (post-pre).||||<.000038
72387437|NCT02280304|144283284|OTHER||Slope|0.02|||<|0.000149|TWO_SIDED|||||Cluster in the right cerebellum (crus 2) p\<0.000149 FDR corrected for multiple comparisons across the whole brain. Bonferroni for multiple seeds p=0.008.|Regression, Linear|Significance is determined when voxel (height) threshold p=.001, cluster threshold p=.05, FDR corrected for multiple tests across the whole brain.||The extent of community participation prior to therapy was correlated with the functional connectivity of the right hippocampus seed after therapy (post-pre).||||<0.000149
72387438|NCT00934089|144283315|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.07||||0.533|TWO_SIDED|90.0|-1.82|3.95|||ANCOVA|||Change at Day 14 8 AM: Analysis was based on analysis of covariance (ANCOVA) using statistical analysis system (SAS) mixed procedure with covariates of baseline IOP, sequence, study period and treatment as fixed effects and participant within sequence as random effect.||3.95|-1.82|0.5330
72387439|NCT00934089|144283315|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.14||||0.9532|TWO_SIDED|90.0|-4.13|3.85|||ANCOVA|||Change at Day 14 10 AM: Analysis was based on ANCOVA using SAS mixed procedure with covariates of baseline IOP, sequence, study period and treatment as fixed effects and participant within sequence as random effect.||3.85|-4.13|0.9532
72387440|NCT00934089|144283315|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.53||||0.2493|TWO_SIDED|90.0|-1.11|6.18|||ANCOVA|||Change at Day 14 12 PM: Analysis was based on ANCOVA using SAS mixed procedure with covariates of baseline IOP, sequence, study period and treatment as fixed effects and participant within sequence as random effect.||6.18|-1.11|0.2493
72387441|NCT00934089|144283315|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.99||||0.2801|TWO_SIDED|90.0|-7.59|1.6|||ANCOVA|||Change at Day 14 2 PM: Analysis was based on ANCOVA using SAS mixed procedure with covariates of baseline IOP, sequence, study period and treatment as fixed effects and participant within sequence as random effect.||1.60|-7.59|0.2801
72387442|NCT00934089|144283315|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.19||||0.9288|TWO_SIDED|90.0|-3.77|3.39|||ANCOVA|||Change at Day 14 4 PM: Analysis was based on ANCOVA using SAS mixed procedure with covariates of baseline IOP, sequence, study period and treatment as fixed effects and participant within sequence as random effect.||3.39|-3.77|0.9288
72495861|NCT03569202|144521378|OTHER||Mean Difference (Final Values)|-2.9808||||0.575|TWO_SIDED|95.0|-13.6005|7.639||A two-sided p-value less than 0.05 was considered statistically significant.|ANOVA|||Between-group comparison, change from baseline||7.6390|-13.6005|0.575
72559060|NCT01243151|144647859|SUPERIORITY_OR_OTHER||LS Mean Difference|14.95|STANDARD_ERROR_OF_MEAN|4.293||0.001|TWO_SIDED|95.0|6.34|23.56|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||23.56|6.34|0.0010
72559061|NCT01243151|144647859|SUPERIORITY_OR_OTHER||LS Mean Difference|10.86|STANDARD_ERROR_OF_MEAN|4.451||0.0179|TWO_SIDED|95.0|1.95|19.78|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||19.78|1.95|0.0179
72559062|NCT01243151|144647859|SUPERIORITY_OR_OTHER||LS Mean Difference|9.06|STANDARD_ERROR_OF_MEAN|4.44||0.0462|TWO_SIDED|95.0|0.16|17.96|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||17.96|0.16|0.0462
72439915|NCT02528188|144393188|SUPERIORITY||LS Mean Difference|-0.34|STANDARD_ERROR_OF_MEAN|1.78||0.848|TWO_SIDED|95.0|-3.84|3.15|||ANCOVA|||Week 16: Percent Impairment While Working: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.||3.15|-3.84|0.8480
72439916|NCT02528188|144393188|SUPERIORITY||LS Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|1.94||0.923|TWO_SIDED|95.0|-4.0|3.63|||ANCOVA|||Week 24: Percent Impairment While Working: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.||3.63|-4.00|0.9230
72439917|NCT02528188|144393188|SUPERIORITY||LS Mean Difference|-1.51|STANDARD_ERROR_OF_MEAN|1.96||0.4421|TWO_SIDED|95.0|-5.36|2.34|||ANCOVA|||Week 24: Percent Impairment While Working: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.||2.34|-5.36|0.4421
72439918|NCT02528188|144393188|SUPERIORITY||LS Mean Difference|3.1|STANDARD_ERROR_OF_MEAN|2.44||0.2049|TWO_SIDED|95.0|-1.7|7.91|||ANCOVA|||Week 56: Percent Impairment While Working: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.||7.91|-1.70|0.2049
72439919|NCT02528188|144393188|SUPERIORITY||LS Mean Difference|4.68|STANDARD_ERROR_OF_MEAN|2.4||0.0527|TWO_SIDED|95.0|-0.05|9.41|||ANCOVA|||Week 56: Percent Impairment While Working: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.||9.41|-0.05|0.0527
72439920|NCT02528188|144393188|SUPERIORITY||LS Mean Difference|-1.63|STANDARD_ERROR_OF_MEAN|1.82||0.3699|TWO_SIDED|95.0|-5.21|1.94|||ANCOVA|||Week 16: Percent Overall Work Impairment: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.||1.94|-5.21|0.3699
72439921|NCT02528188|144393188|SUPERIORITY||LS Mean Difference|-0.48|STANDARD_ERROR_OF_MEAN|1.83||0.7945|TWO_SIDED|95.0|-4.06|3.11|||ANCOVA|||Week 16: Percent Overall Work Impairment: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.||3.11|-4.06|0.7945
72439922|NCT02528188|144393188|SUPERIORITY||LS Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|2.03||0.941|TWO_SIDED|95.0|-4.13|3.83|||ANCOVA|||Week 24: Percent Overall Work Impairment: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.||3.83|-4.13|0.9410
72439923|NCT02528188|144393188|SUPERIORITY||LS Mean Difference|-1.43|STANDARD_ERROR_OF_MEAN|2.05||0.486|TWO_SIDED|95.0|-5.44|2.59|||ANCOVA|||Week 24: Percent Overall Work Impairment: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.||2.59|-5.44|0.4860
72495862|NCT03569202|144521378|OTHER||Mean Difference (Final Values)|-4.75||||0.2098|TWO_SIDED|95.0|-12.2593|2.7593||A two-sided p-value less than 0.05 was considered statistically significant.|ANOVA|||Within-group change from baseline||2.7593|-12.2593|0.2098
72495863|NCT03569202|144521378|OTHER||Mean Difference (Final Values)|-1.7692||||0.6381|TWO_SIDED|95.0|-9.2785|5.7401||A two-sided p-value less than 0.05 was considered statistically significant.|ANOVA|||Within-group change from baseline||5.7401|-9.2785|0.6381
72495864|NCT03569202|144521379|OTHER||Mean Difference (Final Values)|0.8462||||0.271|TWO_SIDED|95.0|-0.6792|2.3715||A two-sided p-value less than 0.05 was considered statistically significant.|ANOVA|||Between-group comparison, change from baseline||2.3715|-0.6792|0.271
72495865|NCT03569202|144521379|OTHER||Mean Difference (Final Values)|1.7115||||0.0025|TWO_SIDED|95.0|0.633|2.7901||A two-sided p-value less than 0.05 was considered statistically significant.|ANOVA|||Within-group change from baseline||2.7901|0.6330|0.0025
72559063|NCT01243151|144647859|SUPERIORITY_OR_OTHER||LS Mean Difference|11.78|STANDARD_ERROR_OF_MEAN|4.358||0.0091|TWO_SIDED|95.0|3.05|20.52|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||20.52|3.05|0.0091
72559064|NCT01243151|144647859|SUPERIORITY_OR_OTHER||LS Mean Difference|7.31|STANDARD_ERROR_OF_MEAN|4.064||0.0774|TWO_SIDED|95.0|-0.83|15.45|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||15.45|-0.83|0.0774
72559065|NCT01243151|144647859|SUPERIORITY_OR_OTHER||LS Mean Difference|7.16|STANDARD_ERROR_OF_MEAN|4.165||0.0909|TWO_SIDED|95.0|-1.18|15.5|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||15.50|-1.18|0.0909
72387443|NCT00934089|144283315|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.98||||0.6459|TWO_SIDED|90.0|-2.62|4.58|||ANCOVA|||Change at Day 14 6 PM: Analysis was based on ANCOVA using SAS mixed procedure with covariates of baseline IOP, sequence, study period and treatment as fixed effects and participant within sequence as random effect.||4.58|-2.62|0.6459
72387444|NCT00934089|144283315|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.06||||0.0527|TWO_SIDED|90.0|0.63|7.48|||ANCOVA|||Change at Day 14 8 PM: Analysis was based on ANCOVA using SAS mixed procedure with covariates of baseline IOP, sequence, study period and treatment as fixed effects and participant within sequence as random effect.||7.48|0.63|0.0527
72387445|NCT00934089|144283315|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.29||||0.1998|TWO_SIDED|90.0|-0.95|7.52|||ANCOVA|||Change at Day 14 10 PM: Analysis was based on ANCOVA using SAS mixed procedure with covariates of baseline IOP, sequence, study period and treatment as fixed effects and participant within sequence as random effect.||7.52|-0.95|0.1998
72387446|NCT00934089|144283315|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.85||||0.6765|TWO_SIDED|90.0|-4.22|2.53|||ANCOVA|||Change at Day 15 12 AM: Analysis was based on ANCOVA using SAS mixed procedure with covariates of baseline IOP, sequence, study period and treatment as fixed effects and participant within sequence as random effect.||2.53|-4.22|0.6765
72387447|NCT00934089|144283315|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.99||||0.6221|TWO_SIDED|90.0|-2.35|4.33|||ANCOVA|||Change at Day 15 4 AM: Analysis was based on ANCOVA using SAS mixed procedure with covariates of baseline IOP, sequence, study period and treatment as fixed effects and participant within sequence as random effect.||4.33|-2.35|0.6221
72387448|NCT00934089|144283315|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.81||||0.3|TWO_SIDED|90.0|-1.11|4.74|||ANCOVA|||Change at Day 15 6 AM: Analysis was based on ANCOVA using SAS mixed procedure with covariates of baseline IOP, sequence, study period and treatment as fixed effects and participant within sequence as random effect.||4.74|-1.11|0.3000
72387449|NCT00934089|144283315|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.24||||0.9103|TWO_SIDED|90.0|-3.85|3.37|||ANCOVA|||Change at Day 15 8 AM: Analysis was based on ANCOVA using SAS mixed procedure with covariates of baseline IOP, sequence, study period and treatment as fixed effects and participant within sequence as random effect.||3.37|-3.85|0.9103
72387450|NCT00934089|144283317|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|59.2|||<|0.001|TWO_SIDED|95.0|38.69|79.7|||Fisher Exact|||Photophobia: p-value was calculated using fisher exact test.||79.70|38.69|<0.001
72439924|NCT02528188|144393188|SUPERIORITY||LS Mean Difference|3.05|STANDARD_ERROR_OF_MEAN|2.62||0.2448|TWO_SIDED|95.0|-2.1|8.2|||ANCOVA|||Week 56: Percent Overall Work Impairment: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.||8.20|-2.10|0.2448
72439925|NCT02528188|144393188|SUPERIORITY||LS Mean Difference|4.96|STANDARD_ERROR_OF_MEAN|2.58||0.0551|TWO_SIDED|95.0|-0.11|10.04|||ANCOVA|||Week 56: Percent Overall Work Impairment: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.||10.04|-0.11|0.0551
72439926|NCT02528188|144393188|SUPERIORITY||LS Mean Difference|-1.21|STANDARD_ERROR_OF_MEAN|1.05||0.247|TWO_SIDED|95.0|-3.26|0.84|||ANCOVA|||Week 16: Percent Activity Impairment: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.||0.84|-3.26|0.2470
72439927|NCT02528188|144393188|SUPERIORITY||LS Mean Difference|-1.98|STANDARD_ERROR_OF_MEAN|1.04||0.057|TWO_SIDED|95.0|-4.01|0.06|||ANCOVA|||Week 16: Percent Activity Impairment: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.||0.06|-4.01|0.0570
72439928|NCT02528188|144393188|SUPERIORITY||LS Mean Difference|-0.12|STANDARD_ERROR_OF_MEAN|1.14||0.917|TWO_SIDED|95.0|-2.36|2.12|||ANCOVA|||Week 24: Percent Activity Impairment: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.||2.12|-2.36|0.9170
72439929|NCT02528188|144393188|SUPERIORITY||LS Mean Difference|-0.77|STANDARD_ERROR_OF_MEAN|1.14||0.4991|TWO_SIDED|95.0|-3.0|1.46|||ANCOVA|||Week 24: Percent Activity Impairment: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.||1.46|-3.00|0.4991
72387451|NCT00934089|144283317|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|-3.56||||0.612|TWO_SIDED|95.0|-14.8|7.68|||Fisher Exact|||Iritis: p-value was calculated using fisher exact test.||7.68|-14.80|0.612
72387452|NCT00934089|144283319|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-52.42||||0.245|TWO_SIDED|90.0|-127.05|22.22|||ANCOVA|||Change at Day 13 8 AM study eye: Analysis was based on ANCOVA using SAS mixed procedure with covariates of baseline IOP, sequence, study period and treatment as fixed effects and participant within sequence as random effect.||22.22|-127.05|0.2450
72387453|NCT00934089|144283319|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|34.51||||0.3068|TWO_SIDED|90.0|-21.89|90.91|||ANCOVA|||Change at Day 13 8 AM fellow eye: Analysis was based on ANCOVA using SAS mixed procedure with covariates of baseline IOP, sequence, study period and treatment as fixed effects and participant within sequence as random effect.||90.91|-21.89|0.3068
72387454|NCT00934089|144283319|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|40.99||||0.2632|TWO_SIDED|90.0|-19.69|101.67|||ANCOVA|||Change at Day 35 8 AM study eye: Analysis was based on ANCOVA using SAS mixed procedure with covariates of baseline IOP, sequence, study period and treatment as fixed effects and participant within sequence as random effect.||101.67|-19.69|0.2632
72439930|NCT02528188|144393188|SUPERIORITY||LS Mean Difference|1.7|STANDARD_ERROR_OF_MEAN|1.44||0.2377|TWO_SIDED|95.0|-1.12|4.52|||ANCOVA|||Week 56: Percent Activity Impairment: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.||4.52|-1.12|0.2377
72439931|NCT02528188|144393188|SUPERIORITY||LS Mean Difference|3.26|STANDARD_ERROR_OF_MEAN|1.44||0.0238|TWO_SIDED|95.0|0.43|6.08|||ANCOVA|||Week 56: Percent Activity Impairment: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.||6.08|0.43|0.0238
72495866|NCT03569202|144521379|OTHER||Mean Difference (Final Values)|0.8654||||0.1134|TWO_SIDED|95.0|-0.2132|1.944||A two-sided p-value less than 0.05 was considered statistically significant.|ANOVA|||Within-group change from baseline||1.9440|-0.2132|0.1134
72559066|NCT01243151|144647859|SUPERIORITY_OR_OTHER||LS Mean Difference|2.13|STANDARD_ERROR_OF_MEAN|4.157||0.6107|TWO_SIDED|95.0|-6.2|10.45|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||10.45|-6.20|0.6107
72387455|NCT00934089|144283319|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.6||||0.8373|TWO_SIDED|90.0|-60.84|47.64|||ANCOVA|||Change at Day 35 8 AM fellow eye: Analysis was based on ANCOVA using SAS mixed procedure with covariates of baseline IOP, sequence, study period and treatment as fixed effects and participant within sequence as random effect.||47.64|-60.84|0.8373
72387456|NCT02555683|144283353|SUPERIORITY||rate ratio|1.04||||0.8|TWO_SIDED|95.0|0.77|1.41||adjusted p-value|negative binomial regression model|Adjusted p-values obtained from the closed testing procedure||||1.41|0.77|0.800
72387457|NCT02555683|144283353|SUPERIORITY||Rate Ratio|0.83||||0.51|TWO_SIDED|95.0|0.61|1.14||adjusted p-value|negative binomial regression model|Adjusted p-values are based on the closed testing procedure||||1.14|0.61|0.510
72387458|NCT02555683|144283354|SUPERIORITY||Mean Difference (Net)|0.08|STANDARD_ERROR_OF_MEAN|0.095||0.819|TWO_SIDED|95.0|-0.11|0.26||adjusted p-value|ANCOVA|Adjusted p-values obtained from the closed testing procedure||||0.26|-0.11|0.819
72387459|NCT02555683|144283354|SUPERIORITY||Mean Difference (Net)|0.14|STANDARD_ERROR_OF_MEAN|0.095||0.591|TWO_SIDED|95.0|-0.05|0.32||adjusted p-vale|ANCOVA|Adjusted p-values obtained from the closed testing procedure||||0.32|-0.05|0.591
72387460|NCT02555683|144283355|SUPERIORITY||Mean Difference (Net)|-0.12|STANDARD_ERROR_OF_MEAN|0.098||0.819|TWO_SIDED|95.0|-0.31|0.07||adjusted p-value|ANCOVA|Adjusted p-values obtained from the closed testing procedure||||0.07|-0.31|0.819
72387461|NCT02555683|144283355|SUPERIORITY||Mean Difference (Net)|-0.17|STANDARD_ERROR_OF_MEAN|0.098||0.591|TWO_SIDED|95.0|-0.37|0.02||adjusted p-value|ANCOVA|Adjusted p-values obtained from the closed testing procedure||||0.02|-0.37|0.591
72439932|NCT02528188|144393196|SUPERIORITY||LS Mean Difference|2.66|STANDARD_ERROR_OF_MEAN|1.08||0.0142|TWO_SIDED|95.0|0.53|4.78|||ANCOVA|||TSQM Effectiveness; Week 16: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline diary average pain as covariates, and study site as a random effect.||4.78|0.53|0.0142
72387462|NCT02555683|144283356|SUPERIORITY||Mean Difference (Net)|0.067|STANDARD_ERROR_OF_MEAN|0.0365||0.8|TWO_SIDED|95.0|-0.005|0.139||adjusted p-value|ANCOVA|Adjusted p-values obtained from the closed testing procedure||||0.139|-0.005|0.800
72387463|NCT02555683|144283356|SUPERIORITY||Mean Difference (Net)|0.05|STANDARD_ERROR_OF_MEAN|0.0363||0.523|TWO_SIDED|95.0|-0.021|0.121||adjusted p-value|ANCOVA|Adjusted p-values obtained from the closed testing procedure||||0.121|-0.021|0.523
72387464|NCT02555683|144283357|SUPERIORITY||rate ratio|0.96||||0.819|TWO_SIDED|95.0|0.75|1.22||adjusted p-value|negative binomial regression model|Adjusted p-values obtained from the closed testing procedure||||1.22|0.75|0.819
72387465|NCT02555683|144283357|SUPERIORITY||Rate Ratio|0.78||||0.51|TWO_SIDED|95.0|0.61|1.01||adjusted p-value|negative binomial regression model|Adjusted p-values are based on the closed testing procedure||||1.01|0.61|0.510
72387466|NCT02555683|144283358|SUPERIORITY||Mean Difference (Net)|0.08|STANDARD_ERROR_OF_MEAN|0.076||0.819|TWO_SIDED|95.0|-0.07|0.23||adjusted p-value|ANCOVA|Adjusted p-values obtained from the closed testing procedure||||0.23|-0.07|0.819
72387467|NCT02555683|144283358|SUPERIORITY||Mean Difference (Net)|0.12|STANDARD_ERROR_OF_MEAN|0.076||0.591|TWO_SIDED|95.0|-0.03|0.27||adjusted p-vale|ANCOVA|Adjusted p-values obtained from the closed testing procedure||||0.27|-0.03|0.591
72387468|NCT02555683|144283359|SUPERIORITY||Mean Difference (Net)|-0.11|STANDARD_ERROR_OF_MEAN|0.079||0.819|TWO_SIDED|95.0|-0.27|0.04||adjusted p-value|ANCOVA|Adjusted p-values obtained from the closed testing procedure||||0.04|-0.27|0.819
72387469|NCT02555683|144283359|SUPERIORITY||Mean Difference (Net)|-0.19|STANDARD_ERROR_OF_MEAN|0.079||0.591|TWO_SIDED|95.0|-0.35|-0.04||adjusted p-value|ANCOVA|Adjusted p-values obtained from the closed testing procedure||||-0.04|-0.35|0.591
72387470|NCT02555683|144283360|SUPERIORITY||Mean Difference (Net)|0.076|STANDARD_ERROR_OF_MEAN|0.0292||0.819|TWO_SIDED|95.0|0.019|0.134||adjusted p-value|ANCOVA|Adjusted p-values obtained from the closed testing procedure||||0.134|0.019|0.819
72387471|NCT02555683|144283360|SUPERIORITY||Mean Difference (Net)|0.04|STANDARD_ERROR_OF_MEAN|0.0292||0.591|TWO_SIDED|95.0|-0.017|0.097||adjusted p-value|ANCOVA|Adjusted p-values obtained from the closed testing procedure||||0.097|-0.017|0.591
72387472|NCT03019185|144283394|SUPERIORITY|A formal test of mean change from baseline in eGFR ≠ 0 was conducted at Week 12.|LS Mean change from baseline|13.37|STANDARD_ERROR_OF_MEAN|1.4111|<|0.0001|TWO_SIDED|95.0|10.48|16.27|||Mixed Models Analysis|Available data from analysis visits Week 1 to Week 12 were included. Missing data were not imputed.||||16.27|10.48|<0.0001
72387473|NCT03019185|144283395|SUPERIORITY||LS Mean difference (Net)|9.49|STANDARD_ERROR_OF_MEAN|1.813|<|0.0001|TWO_SIDED|97.5|5.38|13.6|||Mixed Models Analysis|Available data from analysis visits Week 1 to Week 48 were included. Missing data were not imputed.|Difference is bardoxolone methyl - placebo|||13.60|5.38|<0.0001
72495867|NCT03569202|144521380|OTHER||Mean Difference (Final Values)|2.1731||||0.412|TWO_SIDED|95.0|-3.1016|7.4477||A two-sided p-value less than 0.05 was considered statistically significant.|ANOVA|||Between-group comparison, change from baseline||7.4477|-3.1016|0.412
72559067|NCT01243151|144647859|SUPERIORITY_OR_OTHER||LS Mean Difference|11.59|STANDARD_ERROR_OF_MEAN|4.076||0.0062|TWO_SIDED|95.0|3.42|19.75|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||19.75|3.42|0.0062
72559068|NCT01243151|144647859|SUPERIORITY_OR_OTHER||LS Mean Difference|8.69|STANDARD_ERROR_OF_MEAN|4.712||0.0702|TWO_SIDED|95.0|-0.74|18.13|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||18.13|-0.74|0.0702
72559069|NCT01243151|144647859|SUPERIORITY_OR_OTHER||LS Mean Difference|6.69|STANDARD_ERROR_OF_MEAN|4.807||0.1692|TWO_SIDED|95.0|-2.93|16.32|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||16.32|-2.93|0.1692
72439933|NCT02528188|144393196|SUPERIORITY||LS Mean Difference|4.67|STANDARD_ERROR_OF_MEAN|1.08|<|0.0001|TWO_SIDED|95.0|2.56|6.78|||ANCOVA|||TSQM Effectiveness; Week 16: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline diary average pain as covariates, and study site as a random effect.||6.78|2.56|<0.0001
72439934|NCT02528188|144393196|SUPERIORITY||LS Mean Difference|2.15|STANDARD_ERROR_OF_MEAN|1.45||0.1371|TWO_SIDED|95.0|-0.69|4.99|||ANCOVA|||TSQM Effectiveness; Week 56: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline diary average pain as covariates, and study site as a random effect.||4.99|-0.69|0.1371
72439935|NCT02528188|144393196|SUPERIORITY||LS Mean Difference|0.27|STANDARD_ERROR_OF_MEAN|1.46||0.8524|TWO_SIDED|95.0|-2.6|3.14|||ANCOVA|||TSQM Effectiveness; Week 56: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline diary average pain as covariates, and study site as a random effect.||3.14|-2.60|0.8524
72439936|NCT02528188|144393196|SUPERIORITY||LS Mean Difference|-2.42|STANDARD_ERROR_OF_MEAN|3.8||0.5253|TWO_SIDED|95.0|-9.93|5.09|||ANCOVA|||TSQM Side Effects; Week 16: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline diary average pain as covariates, and study site as a random effect.||5.09|-9.93|0.5253
72439937|NCT02528188|144393196|SUPERIORITY||LS Mean Difference|2.29|STANDARD_ERROR_OF_MEAN|3.71||0.5381|TWO_SIDED|95.0|-5.04|9.62|||ANCOVA|||TSQM Side Effects; Week 16: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline diary average pain as covariates, and study site as a random effect.||9.62|-5.04|0.5381
72439938|NCT02528188|144393196|SUPERIORITY||LS Mean Difference|7.27|STANDARD_ERROR_OF_MEAN|6.44||0.2694|TWO_SIDED|95.0|-5.99|20.54|||ANCOVA|||TSQM Side Effects; Week 56: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline diary average pain as covariates, and study site as a random effect.||20.54|-5.99|0.2694
72439939|NCT02528188|144393196|SUPERIORITY||LS Mean Difference|-9.34|STANDARD_ERROR_OF_MEAN|6.05||0.1349|TWO_SIDED|95.0|-21.8|3.11|||ANCOVA|||TSQM Side Effects; Week 56: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline diary average pain as covariates, and study site as a random effect.||3.11|-21.80|0.1349
72439940|NCT02528188|144393196|SUPERIORITY||LS Mean Difference|1.8|STANDARD_ERROR_OF_MEAN|0.81||0.0264|TWO_SIDED|95.0|0.21|3.38|||ANCOVA|||TSQM Convenience; Week 16: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline diary average pain as covariates, and study site as a random effect.||3.38|0.21|0.0264
72439941|NCT02528188|144393196|SUPERIORITY||LS Mean Difference|2.07|STANDARD_ERROR_OF_MEAN|0.8||0.0098|TWO_SIDED|95.0|0.5|3.65|||ANCOVA|||TSQM Convenience; Week 16: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline diary average pain as covariates, and study site as a random effect.||3.65|0.50|0.0098
72439942|NCT02528188|144393196|SUPERIORITY||LS Mean Difference|1.85|STANDARD_ERROR_OF_MEAN|1.1||0.0937|TWO_SIDED|95.0|-0.31|4.01|||ANCOVA|||TSQM Convenience; Week 56: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline diary average pain as covariates, and study site as a random effect.||4.01|-0.31|0.0937
72439943|NCT02528188|144393196|SUPERIORITY||LS Mean Difference|1.48|STANDARD_ERROR_OF_MEAN|1.11||0.1838|TWO_SIDED|95.0|-0.7|3.67|||ANCOVA|||TSQM Convenience; Week 56: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline diary average pain as covariates, and study site as a random effect.||3.67|-0.70|0.1838
72439944|NCT02528188|144393196|SUPERIORITY||LS Mean Difference|3.18|STANDARD_ERROR_OF_MEAN|1.05||0.0025|TWO_SIDED|95.0|1.12|5.25|||ANCOVA|||TSQM Global Satisfaction; Week 16: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline diary average pain as covariates, and study site as a random effect.||5.25|1.12|0.0025
72559070|NCT01243151|144647859|SUPERIORITY_OR_OTHER||LS Mean Difference|4.31|STANDARD_ERROR_OF_MEAN|4.819||0.3751|TWO_SIDED|95.0|-5.34|13.96|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||13.96|-5.34|0.3751
72559071|NCT01243151|144647859|SUPERIORITY_OR_OTHER||LS Mean Difference|13.65|STANDARD_ERROR_OF_MEAN|4.709||0.0053|TWO_SIDED|95.0|4.23|23.08|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||23.08|4.23|0.0053
72559072|NCT01243151|144647860|SUPERIORITY_OR_OTHER||LS Mean Difference|-30.64|STANDARD_ERROR_OF_MEAN|3.951|<|0.0001|TWO_SIDED|95.0|-38.56|-22.72|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-22.72|-38.56|<0.0001
72559073|NCT01243151|144647860|SUPERIORITY_OR_OTHER||LS Mean Difference|-26.62|STANDARD_ERROR_OF_MEAN|4.084|<|0.0001|TWO_SIDED|95.0|-34.8|-18.44|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-18.44|-34.80|<0.0001
72559074|NCT01243151|144647860|SUPERIORITY_OR_OTHER||LS Mean Difference|-35.27|STANDARD_ERROR_OF_MEAN|4.003|<|0.0001|TWO_SIDED|95.0|-43.29|-27.24|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-27.24|-43.29|<0.0001
72439945|NCT02528188|144393196|SUPERIORITY||LS Mean Difference|3.55|STANDARD_ERROR_OF_MEAN|1.04||0.0007|TWO_SIDED|95.0|1.51|5.6|||ANCOVA|||TSQM Global Satisfaction; Week 16: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline diary average pain as covariates, and study site as a random effect.||5.60|1.51|0.0007
72439946|NCT02528188|144393196|SUPERIORITY||LS Mean Difference|1.94|STANDARD_ERROR_OF_MEAN|1.31||0.1373|TWO_SIDED|95.0|-0.62|4.51|||ANCOVA|||TSQM Global Satisfaction; Week 56: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline diary average pain as covariates, and study site as a random effect.||4.51|-0.62|0.1373
72439947|NCT02528188|144393196|SUPERIORITY||LS Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|1.32||0.996|TWO_SIDED|95.0|-2.59|2.6|||ANCOVA|||TSQM Global Satisfaction; Week 56: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline diary average pain as covariates, and study site as a random effect.||2.60|-2.59|0.9960
72439948|NCT02528188|144393198|SUPERIORITY|||||||0.0823|||||||Cochran-Mantel-Haenszel|||Week 16: Cochran-Mantel-Haenszel test for row mean scores differ, stratified by the combinations of the three stratification factors (index joint, highest Kellgren-Lawrence grade and NSAID)||||0.0823
72439949|NCT02528188|144393198|SUPERIORITY|||||||0.0049|||||||Cochran-Mantel-Haenszel|||Week 16: Cochran-Mantel-Haenszel test for row mean scores differ, stratified by the combinations of the three stratification factors (index joint, highest Kellgren-Lawrence grade and NSAID)||||0.0049
72439950|NCT02528188|144393198|SUPERIORITY|||||||0.0718|||||||Cochran-Mantel-Haenszel|||Week 56: Cochran-Mantel-Haenszel test for row mean scores differ, stratified by the combinations of the three stratification factors (index joint, highest Kellgren-Lawrence grade and NSAID)||||0.0718
72439951|NCT02528188|144393198|SUPERIORITY|||||||0.1947|||||||Cochran-Mantel-Haenszel|||Week 56: Cochran-Mantel-Haenszel test for row mean scores differ, stratified by the combinations of the three stratification factors (index joint, highest Kellgren-Lawrence grade and NSAID)||||0.1947
72439952|NCT02528188|144393199|SUPERIORITY|||||||0.0229|||||||Cochran-Mantel-Haenszel|||Week 16: Cochran-Mantel-Haenszel test for row mean scores differ, stratified by the combinations of the three stratification factors (index joint, highest Kellgren-Lawrence grade and NSAID)||||0.0229
72439953|NCT02528188|144393199|SUPERIORITY|||||||0.0029|||||||Cochran-Mantel-Haenszel|||Week 16: Cochran-Mantel-Haenszel test for row mean scores differ, stratified by the combinations of the three stratification factors (index joint, highest Kellgren-Lawrence grade and NSAID)||||0.0029
72439954|NCT02528188|144393199|SUPERIORITY|||||||0.0266|||||||Cochran-Mantel-Haenszel|||Week 56: Cochran-Mantel-Haenszel test for row mean scores differ, stratified by the combinations of the three stratification factors (index joint, highest Kellgren-Lawrence grade and NSAID)||||0.0266
72439955|NCT02528188|144393199|SUPERIORITY|||||||0.1835|||||||Cochran-Mantel-Haenszel|||Week 56: Cochran-Mantel-Haenszel test for row mean scores differ, stratified by the combinations of the three stratification factors (index joint, highest Kellgren-Lawrence grade and NSAID)||||0.1835
72439956|NCT02528188|144393200|SUPERIORITY||Odds Ratio (OR)|0.63||||0.0076|TWO_SIDED|95.0|0.45|0.88|||Regression, Logistic|||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline diary average pain, baseline WOMAC pain score, classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.||0.88|0.45|0.0076
72439957|NCT02528188|144393200|SUPERIORITY||Odds Ratio (OR)|0.67||||0.0187|TWO_SIDED|95.0|0.48|0.94|||Regression, Logistic|||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline diary average pain, baseline WOMAC pain score, classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.||0.94|0.48|0.0187
72439958|NCT02528188|144393201|SUPERIORITY|||||||0.0074|||||||Log Rank|||Missing data for the selected percentile(s) was due to the Kaplan-Meier estimate not reaching the level for discontinuation due to lack of efficacy.||||0.0074
72439959|NCT02528188|144393201|SUPERIORITY|||||||0.0162|||||||Log Rank|||Missing data for the selected percentile(s) was due to the Kaplan-Meier estimate not reaching the level for discontinuation due to lack of efficacy.||||0.0162
72439960|NCT02528188|144393202|SUPERIORITY||Odds Ratio (OR)|1.15||||0.1136|TWO_SIDED|95.0|0.97|1.38|||Regression, Logistic|||Week 2: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.||1.38|0.97|0.1136
72495868|NCT03569202|144521380|OTHER||Mean Difference (Final Values)|0.01923||||0.9918|TWO_SIDED|95.0|-3.7105|3.749||A two-sided p-value less than 0.05 was considered statistically significant.|ANOVA|||Within-group change from baseline||3.7490|-3.7105|0.9918
72559075|NCT01243151|144647860|SUPERIORITY_OR_OTHER||LS Mean Difference|-33.42|STANDARD_ERROR_OF_MEAN|3.931|<|0.0001|TWO_SIDED|95.0|-41.3|-25.54|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-25.54|-41.30|<0.0001
72559076|NCT01243151|144647860|SUPERIORITY_OR_OTHER||LS Mean Difference|-41.38|STANDARD_ERROR_OF_MEAN|5.467|<|0.0001|TWO_SIDED|95.0|-52.34|-30.42|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-30.42|-52.34|<0.0001
72439961|NCT02528188|144393202|SUPERIORITY||Odds Ratio (OR)|1.08||||0.391|TWO_SIDED|95.0|0.9|1.29|||Regression, Logistic|||Week 2: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.||1.29|0.90|0.3910
72439962|NCT02528188|144393202|SUPERIORITY||Odds Ratio (OR)|1.03||||0.7691|TWO_SIDED|95.0|0.86|1.22|||Regression, Logistic|||Week 4: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.||1.22|0.86|0.7691
72439963|NCT02528188|144393202|SUPERIORITY||Odds Ratio (OR)|0.88||||0.143|TWO_SIDED|95.0|0.73|1.05|||Regression, Logistic|||Week 4: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.||1.05|0.73|0.1430
72439964|NCT02528188|144393202|SUPERIORITY||Odds Ratio (OR)|1.04||||0.6454|TWO_SIDED|95.0|0.87|1.25|||Regression, Logistic|||Week 8: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.||1.25|0.87|0.6454
72439965|NCT02528188|144393202|SUPERIORITY||Odds Ratio (OR)|0.84||||0.0561|TWO_SIDED|95.0|0.7|1.0|||Regression, Logistic|||Week 8: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.||1.00|0.70|0.0561
72439966|NCT02528188|144393202|SUPERIORITY||Odds Ratio (OR)|0.99||||0.9056|TWO_SIDED|95.0|0.82|1.19|||Regression, Logistic|||Week 16: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.||1.19|0.82|0.9056
72439967|NCT02528188|144393202|SUPERIORITY||Odds Ratio (OR)|0.9||||0.2919|TWO_SIDED|95.0|0.75|1.09|||Regression, Logistic|||Week 16: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.||1.09|0.75|0.2919
72439968|NCT02528188|144393202|SUPERIORITY||Odds Ratio (OR)|0.94||||0.4976|TWO_SIDED|95.0|0.78|1.13|||Regression, Logistic|||Week 24: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.||1.13|0.78|0.4976
72559077|NCT01243151|144647860|SUPERIORITY_OR_OTHER||LS Mean Difference|-38.12|STANDARD_ERROR_OF_MEAN|5.61|<|0.0001|TWO_SIDED|95.0|-49.36|-26.88|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-26.88|-49.36|<0.0001
72559078|NCT01243151|144647860|SUPERIORITY_OR_OTHER||LS Mean Difference|-47.42|STANDARD_ERROR_OF_MEAN|5.599|<|0.0001|TWO_SIDED|95.0|-58.64|-36.2|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-36.20|-58.64|<0.0001
72439969|NCT02528188|144393202|SUPERIORITY||Odds Ratio (OR)|0.9||||0.2425|TWO_SIDED|95.0|0.75|1.08|||Regression, Logistic|||Week 24: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.||1.08|0.75|0.2425
72439970|NCT02528188|144393202|SUPERIORITY||Odds Ratio (OR)|0.99||||0.9242|TWO_SIDED|95.0|0.83|1.19|||Regression, Logistic|||Week 32: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.||1.19|0.83|0.9242
72439971|NCT02528188|144393202|SUPERIORITY||Odds Ratio (OR)|0.96||||0.6621|TWO_SIDED|95.0|0.8|1.15|||Regression, Logistic|||Week 32: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.||1.15|0.80|0.6621
72439972|NCT02528188|144393202|SUPERIORITY||Odds Ratio (OR)|1.0||||0.9977|TWO_SIDED|95.0|0.83|1.2|||Regression, Logistic|||Week 40: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.||1.20|0.83|0.9977
72439973|NCT02528188|144393202|SUPERIORITY||Odds Ratio (OR)|1.0||||0.9762|TWO_SIDED|95.0|0.84|1.2|||Regression, Logistic|||Week 40: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.||1.20|0.84|0.9762
72495869|NCT03569202|144521380|OTHER||Mean Difference (Final Values)|-2.1538||||0.2516|TWO_SIDED|95.0|-5.8836|1.5759||A two-sided p-value less than 0.05 was considered statistically significant.|ANOVA|||Within-group change from baseline||1.5759|-5.8836|0.2516
72618997|NCT03615534|144768405|SUPERIORITY|||||||0.058||||||Results were evaluated in terms of adjusted end line ApoA1 levels, embracing the least significant difference (LSD) for pair-wise comparison. Probability of less than 0.05 was considered statistically significant.|MANCOVA|Covariates appearing in MANCOVA model are evaluated at the following baseline values: ApoA1 = 144.6 mg/dl, TG= 240.4 mg/dl, HDL-C = 31.8 mg/dl.||Multivariate Analysis of Covariance (MANCOVA), was applied to assess treatment effects among different arms, comprising the influence of the baseline ApoA1 level as a covariate, with further adjustments for baseline TG and HDL-C levels.||||0.058
72559079|NCT01243151|144647860|SUPERIORITY_OR_OTHER||LS Mean Difference|-46.93|STANDARD_ERROR_OF_MEAN|5.453|<|0.0001|TWO_SIDED|95.0|-57.87|-36.0|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-36.00|-57.87|<0.0001
72439974|NCT02528188|144393202|SUPERIORITY||Odds Ratio (OR)|1.0||||0.9718|TWO_SIDED|95.0|0.83|1.19|||Regression, Logistic|||Week 48: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.||1.19|0.83|0.9718
72387474|NCT03019185|144283396|SUPERIORITY||LS Mean difference (Net)|7.65|STANDARD_ERROR_OF_MEAN|2.144||0.0005|TWO_SIDED|95.0|3.41|11.89|||Mixed Models Analysis|Available data from analysis visits Week 1 to Week 100 (excluding Week 52) were included. Missing data were not imputed.|Difference is bardoxolone methyl - placebo|||11.89|3.41|0.0005
72387475|NCT03019185|144283397|SUPERIORITY|A formal test of mean change from baseline in eGFR ≠ 0 was conducted at Week 48.|LS Mean change from baseline|7.4|STANDARD_ERROR_OF_MEAN|1.9451||0.0008|TWO_SIDED|95.0|3.4|11.39|||Mixed Models Analysis|Available data from analysis visits Week 1 to Week 48 were included. Missing data were not imputed.||||11.39|3.40|0.0008
72387476|NCT03019185|144283398|SUPERIORITY|A formal test of mean change from baseline in eGFR ≠ 0 was conducted at Week 100.|LS Mean change from baseline|4.28|STANDARD_ERROR_OF_MEAN|1.7484||0.015|TWO_SIDED|95.0|0.84|7.72|||Mixed Models Analysis|Available data from analysis visits Week 1 to Week 100 (excluding Week 52) were included. Missing data were not imputed.||||7.72|0.84|0.0150
72387477|NCT03019185|144283399|SUPERIORITY||LS Mean difference (Net)|5.09|STANDARD_ERROR_OF_MEAN|1.656||0.0021|TWO_SIDED|97.5|1.37|8.8|||ANCOVA|Missing eGFR data were imputed using multiple imputation based on the treatment group to which the patient was assigned.|Difference is bardoxolone methyl - placebo|||8.80|1.37|0.0021
72387478|NCT03019185|144283400|SUPERIORITY||LS Mean difference (Net)|4.26|STANDARD_ERROR_OF_MEAN|1.876||0.0232|TWO_SIDED|95.0|0.58|7.94|||ANCOVA|Missing eGFR data were imputed using multiple imputation based on the treatment group to which the patient was assigned.|Difference is bardoxolone methyl - placebo|||7.94|0.58|0.0232
72387479|NCT03355365|144283405|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.0
72387480|NCT03355365|144283406|SUPERIORITY|||||||0.28|||||||Wilcoxon (Mann-Whitney)|||||||0.28
72387481|NCT03355365|144283407|SUPERIORITY|||||||0.4|||||||Wilcoxon (Mann-Whitney)|||||||0.4
72439975|NCT02528188|144393202|SUPERIORITY||Odds Ratio (OR)|1.02||||0.8219|TWO_SIDED|95.0|0.85|1.22|||Regression, Logistic|||Week 48: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.||1.22|0.85|0.8219
72387482|NCT03355365|144283408|SUPERIORITY|||||||0.88|||||||Wilcoxon (Mann-Whitney)|||||||0.88
72387483|NCT03355365|144283409|SUPERIORITY|||||||0.43|||||||Wilcoxon (Mann-Whitney)|||||||.43
72387484|NCT03355365|144283410|SUPERIORITY|||||||0.77|||||||Wilcoxon (Mann-Whitney)|||||||0.77
72439976|NCT02528188|144393202|SUPERIORITY||Odds Ratio (OR)|0.96||||0.6936|TWO_SIDED|95.0|0.8|1.16|||Regression, Logistic|||Week 56: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.||1.16|0.80|0.6936
72387485|NCT03355365|144283411|SUPERIORITY|||||||0.16|||||||Wilcoxon (Mann-Whitney)|||||||0.16
72387486|NCT03355365|144283412|SUPERIORITY|||||||0.71|||||||Wilcoxon (Mann-Whitney)|||||||.71
72387487|NCT03355365|144283413|SUPERIORITY|||||||0.16|||||||Wilcoxon (Mann-Whitney)|||||||0.16
72387488|NCT01773733|144283450|OTHER||||||<|0.001|||||||t-test, 1 sided|||||||<0.001
72387489|NCT00705289|144283451|SUPERIORITY_OR_OTHER||Pearson Product Moment Correlation|0.1402||||0.0003|||||||Test for non-zero correlation|||Relationship between baseline DAS28 and age (prior to infliximab therapy)||||0.0003
72387490|NCT00705289|144283452|SUPERIORITY_OR_OTHER||Pearson Product Moment Correlation|-0.01||||0.7991||95.0|||||Test for non-zero correlation|||Relationship between baseline DAS28 and time since diagnosis (prior to infliximab therapy)||||0.7991
72387491|NCT00705289|144283453|SUPERIORITY_OR_OTHER|||||||0.7152||95.0|||||ANOVA|The association between Baseline DAS28 and gender is based on a one-way Anova.||Relationship between baseline DAS28 and gender (prior to infliximab therapy)||||0.7152
72387492|NCT00705289|144283454|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANOVA|Relationship between DAS28 and Country of Residence was based on a 1-way ANOVA calculated as P-value.||Relationship between baseline DAS28 and country of residence (prior to infliximab therapy)||||<0.0001
72387493|NCT00705289|144283455|SUPERIORITY_OR_OTHER||Mean Baseline DAS28 Raw Score|5.2|STANDARD_DEVIATION|1.15||||95.0|5.1|5.3||||||Relationship between Baseline DAS28 and previous anti-TNF therapy (all subjects, prior to infliximab therapy)||5.3|5.1|
72387494|NCT00705289|144283455|SUPERIORITY_OR_OTHER||Mean Baseline DAS28 Raw Score|5.3|STANDARD_DEVIATION|1.16||||95.0|5.0|5.5||||||Relationship between Baseline DAS28 and previous anti-TNF therapy (subjects with early RA, not treated with anti-TNF; prior to infliximab therapy)||5.5|5.0|
72387495|NCT00705289|144283455|SUPERIORITY_OR_OTHER||Mean Baseline DAS28 Raw Score|5.2|STANDARD_DEVIATION|1.14||||95.0|5.1|5.3||||||Relationship between Baseline DAS28 and previous anti-TNF therapy (subjects with established RA not treated with anti-TNF; prior to infliximab therapy)||5.3|5.1|
72387496|NCT00705289|144283455|SUPERIORITY_OR_OTHER||Mean Baseline DAS28 Raw Score|5.3|STANDARD_DEVIATION|1.16||||95.0|5.1|5.5||||||Relationship between Baseline DAS28 and previous anti-TNF therapy (subjects with established RA who failed or did not tolerate another anti-TNF; prior to infliximab therapy)||5.5|5.1|
72387497|NCT02609828|144283478|SUPERIORITY||Differences in least square (LS) mean|-0.78|STANDARD_ERROR_OF_MEAN|0.37||0.0381|TWO_SIDED|95.0|-1.52|-0.04|||ANCOVA|||Change at Week 8: Analysis of covariance (ANCOVA) model for imputed datasets included treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and baseline average pain intensity at the index bone metastasis cancer pain site and baseline opioid dose as covariates.||-0.04|-1.52|0.0381
72387498|NCT02609828|144283479|SUPERIORITY||Difference in LS mean|-0.36|STANDARD_ERROR_OF_MEAN|0.18||0.0497|TWO_SIDED|95.0|-0.72|0.0|||ANCOVA|||Change at Week 1: ANCOVA model for imputed datasets included treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and baseline average pain intensity at the index bone metastasis cancer pain site and baseline opioid dose as covariates.||-0.00|-0.72|0.0497
72439977|NCT02528188|144393202|SUPERIORITY||Odds Ratio (OR)|1.05||||0.5769|TWO_SIDED|95.0|0.88|1.26|||Regression, Logistic|||Week 56: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.||1.26|0.88|0.5769
72439978|NCT02528188|144393204|SUPERIORITY||LS Mean Ratio|1.02|STANDARD_ERROR_OF_MEAN|0.07||0.7746|TWO_SIDED|95.0|0.89|1.16|||Negative binomial model|||Week 2: Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, NSAID and treatment group.||1.16|0.89|0.7746
72439979|NCT02528188|144393204|SUPERIORITY||LS Mean Ratio|1.01|STANDARD_ERROR_OF_MEAN|0.07||0.8441|TWO_SIDED|95.0|0.89|1.16|||Negative binomial model|||Week 2: Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, NSAID and treatment group.||1.16|0.89|0.8441
72439980|NCT02528188|144393204|SUPERIORITY||LS Mean Ratio|0.97|STANDARD_ERROR_OF_MEAN|0.08||0.658|TWO_SIDED|95.0|0.83|1.13|||Negative binomial model|||Week 4: Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, NSAID and treatment group.||1.13|0.83|0.6580
72495870|NCT03569202|144521381|OTHER||Mean Difference (Final Values)|0.5093||||0.047|TWO_SIDED|95.0|0.007267|1.0113||A two-sided p-value less than 0.05 was considered statistically significant.|ANOVA|||Between-group comparison, change from baseline||1.0113|0.007267|0.047
72495871|NCT03569202|144521381|OTHER||Mean Difference (Final Values)|0.5596||||0.0026|TWO_SIDED|95.0|0.2046|0.9146||A two-sided p-value less than 0.05 was considered statistically significant.|ANOVA|||Within-group change from baseline||0.9146|0.2046|0.0026
72559080|NCT01243151|144647860|SUPERIORITY_OR_OTHER||LS Mean Difference|-45.37|STANDARD_ERROR_OF_MEAN|4.275|<|0.0001|TWO_SIDED|95.0|-53.96|-36.77|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-36.77|-53.96|<0.0001
72559081|NCT01243151|144647860|SUPERIORITY_OR_OTHER||LS Mean Difference|-48.78|STANDARD_ERROR_OF_MEAN|4.374|<|0.0001|TWO_SIDED|95.0|-57.58|-39.99|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-39.99|-57.58|<0.0001
72559082|NCT01243151|144647860|SUPERIORITY_OR_OTHER||LS Mean Difference|-54.49|STANDARD_ERROR_OF_MEAN|4.346|<|0.0001|TWO_SIDED|95.0|-63.23|-45.75|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-45.75|-63.23|<0.0001
72439981|NCT02528188|144393204|SUPERIORITY||LS Mean Ratio|0.91|STANDARD_ERROR_OF_MEAN|0.07||0.2279|TWO_SIDED|95.0|0.78|1.06|||Negative binomial model|||Week 4: Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, NSAID and treatment group.||1.06|0.78|0.2279
72439982|NCT02528188|144393204|SUPERIORITY||LS Mean Ratio|1.0|STANDARD_ERROR_OF_MEAN|0.09||0.9986|TWO_SIDED|95.0|0.84|1.18|||Negative binomial model|||Week 8: Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, NSAID and treatment group.||1.18|0.84|0.9986
72439983|NCT02528188|144393204|SUPERIORITY||LS Mean Ratio|0.86|STANDARD_ERROR_OF_MEAN|0.07||0.0771|TWO_SIDED|95.0|0.72|1.02|||Negative binomial model|||Week 8: Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, NSAID and treatment group.||1.02|0.72|0.0771
72439984|NCT02528188|144393204|SUPERIORITY||LS Mean Ratio|0.93|STANDARD_ERROR_OF_MEAN|0.09||0.4485|TWO_SIDED|95.0|0.77|1.13|||Negative binomial model|||Week 16: Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, NSAID and treatment group.||1.13|0.77|0.4485
72439985|NCT02528188|144393204|SUPERIORITY||LS Mean Ratio|0.9|STANDARD_ERROR_OF_MEAN|0.09||0.2817|TWO_SIDED|95.0|0.74|1.09|||Negative binomial model|||Week 16: Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, NSAID and treatment group.||1.09|0.74|0.2817
72559083|NCT01243151|144647860|SUPERIORITY_OR_OTHER||LS Mean Difference|-51.75|STANDARD_ERROR_OF_MEAN|4.222|<|0.0001|TWO_SIDED|95.0|-60.25|-43.26|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-43.26|-60.25|<0.0001
72559084|NCT01243151|144647860|SUPERIORITY_OR_OTHER||LS Mean Difference|-40.82|STANDARD_ERROR_OF_MEAN|4.373|<|0.0001|TWO_SIDED|95.0|-49.58|-32.07|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-32.07|-49.58|<0.0001
72495872|NCT03569202|144521381|OTHER||Mean Difference (Final Values)|0.05032||||0.777|TWO_SIDED|95.0|-0.3047|0.4053||A two-sided p-value less than 0.05 was considered statistically significant.|ANOVA|||Within-group change from baseline||0.4053|-0.3047|0.7770
72495873|NCT03569202|144521382|OTHER||Wilcoxon Z statistic|-0.7604||||0.447|TWO_SIDED|||||A two-sided p-value less than 0.05 was considered statistically significant.|Wilcoxon rank sum test|||Between-group comparison, change from baseline||||0.447
72495874|NCT03569202|144521382|OTHER|||||||0.014||||||A two-sided p-value less than 0.05 was considered statistically significant.|Wilcoxon rank sum test|||Within-group change from baseline||||0.014
72495875|NCT03569202|144521382|OTHER|||||||0.07||||||A two-sided p-value less than 0.05 was considered statistically significant.|Wilcoxon rank sum test|||Within-group change from baseline||||0.070
72439986|NCT02528188|144393204|SUPERIORITY||LS Mean Ratio|0.94|STANDARD_ERROR_OF_MEAN|0.09||0.5426|TWO_SIDED|95.0|0.79|1.13|||Negative binomial model|||Week 24: Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, NSAID and treatment group.||1.13|0.79|0.5426
72439987|NCT02528188|144393204|SUPERIORITY||LS Mean Ratio|0.94|STANDARD_ERROR_OF_MEAN|0.09||0.5385|TWO_SIDED|95.0|0.79|1.13|||Negative binomial model|||Week 24: Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, NSAID and treatment group.||1.13|0.79|0.5385
72439988|NCT02528188|144393204|SUPERIORITY||LS Mean Ratio|0.94|STANDARD_ERROR_OF_MEAN|0.09||0.5041|TWO_SIDED|95.0|0.79|1.12|||Negative binomial model|||Week 32: Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, NSAID and treatment group.||1.12|0.79|0.5041
72439989|NCT02528188|144393204|SUPERIORITY||LS Mean Ratio|0.93|STANDARD_ERROR_OF_MEAN|0.08||0.441|TWO_SIDED|95.0|0.78|1.11|||Negative binomial model|||Week 32: Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, NSAID and treatment group.||1.11|0.78|0.4410
72439990|NCT02528188|144393204|SUPERIORITY||LS Mean Ratio|0.97|STANDARD_ERROR_OF_MEAN|0.09||0.7426|TWO_SIDED|95.0|0.81|1.16|||Negative binomial model|||Week 40: Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, NSAID and treatment group.||1.16|0.81|0.7426
72439991|NCT02528188|144393204|SUPERIORITY||LS Mean Ratio|0.97|STANDARD_ERROR_OF_MEAN|0.09||0.7469|TWO_SIDED|95.0|0.81|1.16|||Negative binomial model|||Week 40: Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, NSAID and treatment group.||1.16|0.81|0.7469
72439992|NCT02528188|144393204|SUPERIORITY||LS Mean Ratio|0.96|STANDARD_ERROR_OF_MEAN|0.09||0.6784|TWO_SIDED|95.0|0.81|1.15|||Negative binomial model|||Week 48: Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, NSAID and treatment group.||1.15|0.81|0.6784
72439993|NCT02528188|144393204|SUPERIORITY||LS Mean Ratio|1.01|STANDARD_ERROR_OF_MEAN|0.09||0.8822|TWO_SIDED|95.0|0.85|1.21|||Negative binomial model|||Week 48: Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, NSAID and treatment group.||1.21|0.85|0.8822
72439994|NCT02528188|144393204|SUPERIORITY||LS Mean Ratio|0.99|STANDARD_ERROR_OF_MEAN|0.09||0.9119|TWO_SIDED|95.0|0.83|1.18|||Negative binomial model|||Week 56: Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, NSAID and treatment group.||1.18|0.83|0.9119
72495876|NCT03569202|144521383|OTHER||Wilcoxon Z statistic|-0.6396||||0.522|TWO_SIDED|||||A two-sided p-value less than 0.05 was considered statistically significant.|Wilcoxon rank sum test|||Between-group comparison, change from baseline||||0.522
72495877|NCT03569202|144521383|OTHER|||||||0.119||||||A two-sided p-value less than 0.05 was considered statistically significant.|Wilcoxon rank sum test|||Within-group change from baseline||||0.119
72495878|NCT03569202|144521383|OTHER|||||||0.9||||||A two-sided p-value less than 0.05 was considered statistically significant.|Wilcoxon rank sum test|||Within-group change from baseline||||0.900
72495879|NCT03569202|144521384|OTHER||Wilcoxon Z statistic|-0.5387||||0.59|TWO_SIDED|||||A two-sided p-value less than 0.05 was considered statistically significant.|Wilcoxon rank sum test|||Between-group comparison, change from baseline||||0.590
72495880|NCT03569202|144521384|OTHER|||||||0.043||||||A two-sided p-value less than 0.05 was considered statistically significant.|Wilcoxon rank sum test|||Within-group change from baseline||||0.043
72495881|NCT03569202|144521384|OTHER|||||||0.442||||||A two-sided p-value less than 0.05 was considered statistically significant.|Wilcoxon rank sum test|||Within-group change from baseline||||0.442
72495882|NCT03569202|144521386|OTHER||Wilcoxon Z statistic|0.9208||||0.357|TWO_SIDED|||||A two-sided p-value less than 0.05 was considered statistically significant.|Wilcoxon rank sum test|||Between-group comparison, change from baseline||||0.357
72439995|NCT02528188|144393204|SUPERIORITY||LS Mean Ratio|1.06|STANDARD_ERROR_OF_MEAN|0.09||0.5148|TWO_SIDED|95.0|0.89|1.26|||Negative binomial model|||Week 56: Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, NSAID and treatment group.||1.26|0.89|0.5148
72439996|NCT02528188|144393206|SUPERIORITY||LS Mean Ratio|0.87|STANDARD_ERROR_OF_MEAN|0.13||0.3348|TWO_SIDED|95.0|0.66|1.15|||Negative binomial model|||Week 2: Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, NSAID and treatment group.||1.15|0.66|0.3348
72439997|NCT02528188|144393206|SUPERIORITY||LS Mean Ratio|0.88|STANDARD_ERROR_OF_MEAN|0.13||0.3595|TWO_SIDED|95.0|0.66|1.16|||Negative binomial model|||Week 2: Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, NSAID and treatment group.||1.16|0.66|0.3595
72439998|NCT02528188|144393206|SUPERIORITY||LS Mean Ratio|0.75|STANDARD_ERROR_OF_MEAN|0.13||0.0854|TWO_SIDED|95.0|0.54|1.04|||Negative binomial model|||Week 4: Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, NSAID and treatment group.||1.04|0.54|0.0854
72439999|NCT02528188|144393206|SUPERIORITY||LS Mean Ratio|0.69|STANDARD_ERROR_OF_MEAN|0.12||0.0281|TWO_SIDED|95.0|0.5|0.96|||Negative binomial model|||Week 4: Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, NSAID and treatment group.||0.96|0.50|0.0281
72495883|NCT03569202|144521386|OTHER|||||||0.001||||||A two-sided p-value less than 0.05 was considered statistically significant.|Wilcoxon rank sum test|||Within-group change from baseline||||0.001
72495884|NCT03569202|144521386|OTHER|||||||0.065||||||A two-sided p-value less than 0.05 was considered statistically significant.|Wilcoxon rank sum test|||Within-group change from baseline||||0.065
72495885|NCT03569202|144521387|OTHER||Wilcoxon Z statistic|1.044||||0.296|TWO_SIDED|||||A two-sided p-value less than 0.05 was considered statistically significant.|Wilcoxon rank sum test|||Between-group comparison, change from baseline||||0.296
72495886|NCT03569202|144521387|OTHER|||||||0.012||||||A two-sided p-value less than 0.05 was considered statistically significant.|Wilcoxon rank sum test|||Within-group change from baseline||||0.012
72495887|NCT03569202|144521387|OTHER||||||>|0.05||||||A two-sided p-value less than 0.05 was considered statistically significant.|Wilcoxon rank sum test|||Within-group change from baseline||||>0.05
72495888|NCT03569202|144521389|OTHER||Mean Difference (Final Values)|-1.9911||||0.764|TWO_SIDED|95.0|-15.6117|11.6295||A two-sided p-value less than 0.05 was considered statistically significant.|ANOVA|||Between-group comparison, change from baseline||11.6295|-15.6117|0.764
72440000|NCT02528188|144393206|SUPERIORITY||LS Mean Ratio|0.7|STANDARD_ERROR_OF_MEAN|0.13||0.0595|TWO_SIDED|95.0|0.49|1.01|||Negative binomial model|||Week 8: Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, NSAID and treatment group.||1.01|0.49|0.0595
72440001|NCT02528188|144393206|SUPERIORITY||LS Mean Ratio|0.57|STANDARD_ERROR_OF_MEAN|0.11||0.003|TWO_SIDED|95.0|0.4|0.83|||Negative binomial model|||Week 8: Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, NSAID and treatment group.||0.83|0.40|0.0030
72440002|NCT02528188|144393206|SUPERIORITY||LS Mean Ratio|0.73|STANDARD_ERROR_OF_MEAN|0.15||0.1389|TWO_SIDED|95.0|0.48|1.11|||Negative binomial model|||Week 16: Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, NSAID and treatment group.||1.11|0.48|0.1389
72440003|NCT02528188|144393206|SUPERIORITY||LS Mean Ratio|0.68|STANDARD_ERROR_OF_MEAN|0.14||0.0709|TWO_SIDED|95.0|0.45|1.03|||Negative binomial model|||Week 16: Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, NSAID and treatment group.||1.03|0.45|0.0709
72440004|NCT02528188|144393215|SUPERIORITY|||||||0.6037|||||||Cochran-Mantel-Haenszel|||Week 4: Cochran-Mantel-Haenszel test for row mean scores differ, stratified by the combinations of the three stratification factors (index joint, highest Kellgren-Lawrence grade and NSAID)||||0.6037
72440005|NCT02528188|144393215|SUPERIORITY|||||||0.1928|||||||Cochran-Mantel-Haenszel|||Week 4: Cochran-Mantel-Haenszel test for row mean scores differ, stratified by the combinations of the three stratification factors (index joint, highest Kellgren-Lawrence grade and NSAID)||||0.1928
72440006|NCT02528188|144393215|SUPERIORITY|||||||0.7204|||||||Cochran-Mantel-Haenszel|||Week 8: Cochran-Mantel-Haenszel test for row mean scores differ, stratified by the combinations of the three stratification factors (index joint, highest Kellgren-Lawrence grade and NSAID)||||0.7204
72440007|NCT02528188|144393215|SUPERIORITY|||||||0.7969|||||||Cochran-Mantel-Haenszel|||Week 8: Cochran-Mantel-Haenszel test for row mean scores differ, stratified by the combinations of the three stratification factors (index joint, highest Kellgren-Lawrence grade and NSAID)||||0.7969
72440008|NCT02528188|144393215|SUPERIORITY|||||||0.7857|||||||Cochran-Mantel-Haenszel|||Week 16: Cochran-Mantel-Haenszel test for row mean scores differ, stratified by the combinations of the three stratification factors (index joint, highest Kellgren-Lawrence grade and NSAID)||||0.7857
72440009|NCT02528188|144393215|SUPERIORITY|||||||0.6627|||||||Cochran-Mantel-Haenszel|||Week 16: Cochran-Mantel-Haenszel test for row mean scores differ, stratified by the combinations of the three stratification factors (index joint, highest Kellgren-Lawrence grade and NSAID)||||0.6627
72559085|NCT01243151|144647860|SUPERIORITY_OR_OTHER||LS Mean Difference|-43.75|STANDARD_ERROR_OF_MEAN|4.464|<|0.0001|TWO_SIDED|95.0|-52.68|-34.81|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-34.81|-52.68|<0.0001
72440010|NCT02528188|144393215|SUPERIORITY|||||||0.9867|||||||Cochran-Mantel-Haenszel|||Week 24: Cochran-Mantel-Haenszel test for row mean scores differ, stratified by the combinations of the three stratification factors (index joint, highest Kellgren-Lawrence grade and NSAID)||||0.9867
72440011|NCT02528188|144393215|SUPERIORITY|||||||0.819|||||||Cochran-Mantel-Haenszel|||Week 24: Cochran-Mantel-Haenszel test for row mean scores differ, stratified by the combinations of the three stratification factors (index joint, highest Kellgren-Lawrence grade and NSAID)||||0.8190
72440012|NCT02528188|144393215|SUPERIORITY|||||||0.7284|||||||Cochran-Mantel-Haenszel|||Week 56: Cochran-Mantel-Haenszel test for row mean scores differ, stratified by the combinations of the three stratification factors (index joint, highest Kellgren-Lawrence grade and NSAID)||||0.7284
72440013|NCT02528188|144393215|SUPERIORITY|||||||0.1545|||||||Cochran-Mantel-Haenszel|||Week 56: Cochran-Mantel-Haenszel test for row mean scores differ, stratified by the combinations of the three stratification factors (index joint, highest Kellgren-Lawrence grade and NSAID)||||0.1545
72440014|NCT00933400|144393256|EQUIVALENCE|equivalence margin = 0|Percent Difference|0.02|||||TWO_SIDED|95.0|-5.6|5.7||||||Difference in AMI rate. NULL: equal rates of AMI in both Groups.||5.7|-5.6|
72440015|NCT00933400|144393257|EQUIVALENCE|equivalence margin = 0|Difference (rates)|26.8|||||TWO_SIDED|95.0|21.4|32.2||||||Difference in Discharge rates. H0: equal rates of Discharge in both Groups.||32.2|21.4|
72440016|NCT00933400|144393257|EQUIVALENCE|equivalence margin = 0|Difference (percents)|5.6|||||TWO_SIDED|95.0|0.0|11.2|||||exact procedures were used to estimate and compare rates of detection for significant coronary disease|Difference in diagnosis rate of Significant coronary disease at index visit. H0: equal rates in both Groups.||11.2|0.0|
72440017|NCT00933400|144393259|SUPERIORITY||binomial proportion|26.8|||||TWO_SIDED|95.0|21.4|32.2|||||Exact confidence intervals for the difference in proportions|H0: no difference in Patient disposition (Discharge) rates between arms||32.2|21.4|
72559086|NCT01243151|144647860|SUPERIORITY_OR_OTHER||LS Mean Difference|-52.36|STANDARD_ERROR_OF_MEAN|4.437|<|0.0001|TWO_SIDED|95.0|-61.25|-43.48|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-43.48|-61.25|<0.0001
72618998|NCT03615534|144768405|SUPERIORITY|||||||0.067||||||Results were evaluated in terms of adjusted end line ApoB levels, embracing the least significant difference (LSD) for pair-wise comparison. Probability of less than 0.05 was considered statistically significant.|MANCOVA|Covariates appearing in MANCOVA model are evaluated at the following baseline values:ApoB=133.1, RC=48.9,TC=199.9, Non HDL-C=168.0, d-LDL-C=119.1mg/dl||Multivariate Analysis of Covariance (MANCOVA), was applied to assess treatment effects among different arms, comprising the influence of the baseline ApoB level as a covariate, with further adjustments for baselineTC, Non HDL-C, dLDL-C, and RC .||||0.067
72440018|NCT00933400|144393261|EQUIVALENCE|The trial was powered to test the principal hypothesis that the major adverse cardiac event (MACE, including myocardial infarction and cardiac death) rate among patients found not to have significant CAD on CCTA exceeds 1%|binomial proportion|-0.4|||||TWO_SIDED|95.0|-6.0|5.2|||||Exact confidence intervals for the difference in proportions|Compare all cause mortality between groups||5.2|-6.0|
72440019|NCT00933400|144393261|EQUIVALENCE|The trial was powered to test the principal hypothesis that the major adverse cardiac event (MACE, including myocardial infarction and cardiac death) rate among patients found not to have significant CAD on CCTA exceeds 1%|binomial proportion|0.1|||||TWO_SIDED|95.0|-5.5|5.7|||||Exact confidence intervals for the difference in proportions|Compare Cardiac Death between groups||5.7|-5.5|
72440020|NCT00933400|144393261|EQUIVALENCE|The trial was powered to test the principal hypothesis that the major adverse cardiac event (MACE, including myocardial infarction and cardiac death) rate among patients found not to have significant CAD on CCTA exceeds 1%|binomial proportion|0.1|||||TWO_SIDED|95.0|-5.6|5.9|||||Exact confidence intervals for the difference in proportions|Compare AMI between groups||5.9|-5.6|
72440021|NCT00933400|144393261|EQUIVALENCE|The trial was powered to test the principal hypothesis that the major adverse cardiac event (MACE, including myocardial infarction and cardiac death) rate among patients found not to have significant CAD on CCTA exceeds 1%|binomial proportion|3.0|||||TWO_SIDED|95.0|-5.5|6.0|||||Exact confidence intervals for the difference in proportions|Compare MACE between groups||6.0|-5.5|
72440022|NCT00933400|144393261|EQUIVALENCE|The trial was powered to test the principal hypothesis that the major adverse cardiac event (MACE, including myocardial infarction and cardiac death) rate among patients found not to have significant CAD on CCTA exceeds 1%|binomial proportion|1.3|||||TWO_SIDED|95.0|-4.4|7.0|||||Exact confidence intervals for the difference in proportions|Compare Revascularization between groups||7.0|-4.4|
72440023|NCT00716859|144393262|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|If lower limit of 95% Confidence Interval (CI) for treatment difference is above non-inferiority margin, then non-inferiority concluded. If lower limit of 95% CI for treatment difference is above non-inferiority margin and above zero, then superiority concluded. The difference and 95% CI of the difference in IOP reduction (Week 12) was computed from an analysis of covariance (ANCOVA) model with treatment and baseline diagnosis as factors and baseline IOP as covariate.|Mean Difference (Net)|1.46|||||TWO_SIDED|95.0|-0.81|3.74||||||Null hypothesis: latanoprost inferior to timolol (0.5 percent \[%\] optionally 0.25% for participants younger than 3 years). Power calculation: assuming common standard deviation (7 mmHg), 110 participants have 84% power to demonstrate latanoprost not inferior to timolol within 3 mmHg margin, assuming latanoprost has 1 mmHg reduction more than timolol in mean change from baseline IOP.||3.74|-0.81|
72440024|NCT00716859|144393263|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.68|||||TWO_SIDED|95.0|-1.66|3.02||||||||3.02|-1.66|
72440025|NCT00716859|144393264|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|1.62|||||TWO_SIDED|95.0|-1.0|4.25||||||||4.25|-1.00|
72440026|NCT00716859|144393265|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.4085|||||TWO_SIDED|95.0|-1.1|2.67||||||||2.67|-1.10|
72440027|NCT00716859|144393270|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3315|TWO_SIDED||||||Cochran-Mantel-Haenszel|P-value from a Cochran-Mantel-Haenszel chi-square test stratified by baseline diagnosis (PCG vs non-PCG).||||||0.3315
72440028|NCT02918071|144393290|OTHER||percentage|97.4|||||TWO_SIDED|95.0|92.63|99.46|||Clopper-pearson Exact CI|One sample Confidence Interval (Week 12)|Percentage of patients successfully administered benralizumab with an AI at home (Week 12)|||99.46|92.63|
72440029|NCT02918071|144393290|OTHER||Percentage|96.6|||||TWO_SIDED|95.0|91.41|99.05|||Clopper-pearson Exact CI|One sample Confidence Interval (Week 16)|Percentage of patients who successfully administered benralizumab with an AI at home (Week 16)|||99.05|91.41|
72440030|NCT02918071|144393290|OTHER||Percentage|93.1|||||TWO_SIDED|95.0|86.86|96.98|||Clopper-pearson Exact CI|One sample Confidence Interval (Week 12 and 16)|Percentage of patients who successfully administered benralizumab with an AI at home (Week 12 and 16)|||96.98|86.86|
72440031|NCT02918071|144393291|OTHER||Percentage|97.4|||||TWO_SIDED|95.0|92.69|99.47|||Clopper-pearson Exact CI|One sample Confidence Interval (Week 12)|Percentage of patients returned functional AI administered at home (Week 12)|||99.47|92.69|
72440032|NCT02918071|144393291|OTHER||Percentage|96.6|||||TWO_SIDED|95.0|91.48|99.06|||Clopper Pearson Exact CI|One sample confidence interval (Week 16)|Percentage of patients returned functional AI administered at home (Week 16)|||99.06|91.48|
72440033|NCT02918071|144393292|OTHER||Percentage|0.0|||||TWO_SIDED|95.0|0.0|3.0|||Clopper-pearson Exact CI|One sample Confidence Interval (Week 0)|Percentage of mulfunctioning AI used to administer benralizumab at home or clinic (Week 0)|||3.00|0.00|
72440034|NCT02918071|144393292|OTHER||Percentage|0.8|||||TWO_SIDED|95.0|0.02|4.52|||Clopper-pearson Exact CI|One sample Confidence Interval (Week 4)|Percentage of malfunctioning AI used to administer benralizumab at home or clinic (Week 4)|||4.52|0.02|
72440035|NCT02918071|144393292|OTHER||Percentage|0.8|||||TWO_SIDED|95.0|0.02|4.59|||Clopper-pearson Exact CI|One sample Confidence Interval (Week 8)|Percentage of malfunctioning AI used to administer benralizumab at home or clinic (Week 8)|||4.59|0.02|
72440036|NCT02918071|144393292|OTHER||Percentage|2.6|||||TWO_SIDED|95.0|0.53|7.31|||Clopper-pearson Exact CI|One sample Confidence Interval (Week 12)|Percentage of malfunctioning AI used to administer benralizumab at home or clinic (Week 12)|||7.31|0.53|
72440037|NCT02918071|144393292|OTHER||Percentage|3.4|||||TWO_SIDED|95.0|0.94|8.52|||Clopper-pearson Exact CI|One sample Confidence Interval (Week 16)|Percentage of malfunctioning AI used to administer benralizumab at home or clinic (Week 16)|||8.52|0.94|
72440038|NCT02918071|144393292|OTHER||Percentage|0.6|||||TWO_SIDED|95.0|0.07|1.99|||Clopper-pearson Exact CI|One sample Confidence Interval (Week 0 to 8)|Percentage of malfunctioning AI used to administer benralizumab at home or clinic (Week 0 to 8)|||1.99|0.07|
72440039|NCT02918071|144393292|OTHER||Percentage|3.0|||||TWO_SIDED|95.0|1.21|6.07|||Clopper-pearson Exact CI|One sample Confidence Interval (Week 12 to 16)|Percentage of malfunctioning AI used to administer benralizumab at home or clinic (Week 12 to 16)|||6.07|1.21|
72440040|NCT02918071|144393292|OTHER||Percentage|1.5|||||TWO_SIDED|95.0|0.69|2.85|||Clopper-pearson Exact CI|One sample Confidence Interval (Week 0 to 16)|Percentage of malfunctioning AI used to administer benralizumab at home or clinic (Week 0 to 16)|||2.85|0.69|
72440041|NCT03149991|144393320|SUPERIORITY|The unstructured covariance matrix structure was used to model nesting of observations within persons. Non-significant site interaction effects were removed one at a time. Least squares means estimates of the linear fixed effects model on SDQ change scores, adjusting for baseline covariates was used to test the primary hypothesis via contrast statements.|Mean Difference (Final Values)|-0.11|STANDARD_ERROR_OF_MEAN|0.15||0.46|TWO_SIDED||||||Mixed Models Analysis|Because sample sizes per site varied substantially, we used the Kenward-Roger degrees of freedom method.|degrees of freedom = 44.5; t=-0.74|SDQ total was primary outcome \& Day 14 primary endpoint. Change from baseline was calculated for each person at each follow-up. Change score was the dependent variable in a linear fixed effects model, where a (-)number = less severe depression. For group comparison, treatment was coded as 1 \& placebo as 0, thus a (-)value means treatment doing better. Fixed effects: group(brex v placebo), day(1-28), site(6 sites). All 2-\& 3-way interactions were included, as well as a priori defined covariates.||||0.46
72440042|NCT03149991|144393320|SUPERIORITY||Mean Difference (Final Values)|0.22|STANDARD_ERROR_OF_MEAN|0.11||0.04|TWO_SIDED||||||Mixed Models Analysis||Degrees of freedom = 41.3; t=2.07.|Secondary Aim: To evaluate the short-term effect of brexpiprazole, as measured by the Symptoms of Depression Questionnaire (SDQ), on Day 2. We used the same model as in Aim 1 to test this hypothesis.||||0.04
72440043|NCT03149991|144393320|SUPERIORITY||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.21||0.92|TWO_SIDED||||||Mixed Models Analysis||Degrees of freedom=38.2; t=0.10.|To evaluate the long-term effect of brexpiprazole as measured by the Symptoms of Depression Questionnaire (SDQ) on Day 28. The same model as was used in Aim 1 was used to test this hypothesis.||||0.92
72440044|NCT03149991|144393321|SUPERIORITY||Chi-squared test|0.51||||0.47|TWO_SIDED|||||This p-value was not adjusted, however there were adjustments when using a logistic regression in Statistical Analysis #2.|Chi-squared|||We used a Chi-squared test to assess differences between treatment and control in terms of percent of participants achieving a long-term sustained response, as measured by achieving a 50% or greater reduction on the MADRS on Day 28.||||0.47
72440045|NCT03149991|144393321|SUPERIORITY||Odds Ratio (OR)|1.83||||0.35|TWO_SIDED|95.0|0.52|6.44|||Regression, Logistic|Adjusted for a priori defined covariates also included in Aim 1.||Logistic regression was used to assess a difference in 50% reduction on the MADRS on Day 28 between groups.||6.44|0.52|0.35
72440046|NCT03149991|144393322|SUPERIORITY|We used contrast tests comparing brexpiprazole and placebo on the a priori specified days of interest.|Mean Difference (Final Values)|3.39|STANDARD_ERROR_OF_MEAN|1.59||0.04|TWO_SIDED|||||Because tests were conducted for secondary outcomes, p-values were not corrected for multiple testing.|Mixed Models Analysis||degrees of freedom = 41.0, t=2.13.|The same model building approach as used for the primary outcome variable was used for the secondary outcome variables. As per the primary outcome variable, the change scores (i.e., compared to baseline) were the dependent variables of interest. For each secondary outcome variable, non-significant site interaction effects were removed one at a time. This analysis is for the MADRS change scores, reporting here information for Day 2.||||0.04
72440047|NCT03149991|144393322|SUPERIORITY|We used contrast tests comparing brexpiprazole and placebo on the a priori specified days of interest.|Mean Difference (Final Values)|-1.03|STANDARD_ERROR_OF_MEAN|2.94||0.73|TWO_SIDED|||||Because these tests were conducted for secondary outcomes, p-values were not corrected for multiple testing.|Mixed Models Analysis||df = 44.2, t=-0.35|The same model building approach as used for the primary outcome variable was used for the secondary outcome variables. As per the primary outcome variable, the change scores (i.e., compared to baseline) were the dependent variables of interest. For each secondary outcome variable, non-significant site interaction effects were removed one at a time. This analysis is for the MADRS change scores, reporting here information for Day 14.||||0.73
72440048|NCT03149991|144393322|SUPERIORITY|We used contrast tests comparing brexpiprazole and placebo on the a priori specified days of interest.|Mean Difference (Final Values)|-2.86|STANDARD_ERROR_OF_MEAN|3.16||0.37|TWO_SIDED|||||Because these tests were conducted for secondary outcomes, p-values were not corrected for multiple testing.|Mixed Models Analysis||df =44.8, t=-0.91|The same model building approach as used for the primary outcome variable was used for the secondary outcome variables. As per the primary outcome variable, the change scores (i.e., compared to baseline) were the dependent variables of interest. For each secondary outcome variable, non-significant site interaction effects were removed one at a time. This analysis is for the MADRS change scores, reporting here information for Day 28.||||0.37
72440049|NCT03149991|144393322|SUPERIORITY|We used contrast tests comparing brexpiprazole and placebo on the a priori specified days of interest.|Mean Difference (Final Values)|1.66|STANDARD_ERROR_OF_MEAN|0.85||0.06|TWO_SIDED|||||Because these tests were conducted for secondary outcomes, p-values were not corrected for multiple testing.|Mixed Models Analysis||degrees of freedom = 40.3, t=1.94.|The same model building approach as used for the primary outcome variable was used for the secondary outcome variables. As per the primary outcome variable, the change scores (i.e., compared to baseline) were the dependent variables of interest. For each secondary outcome variable, non-significant site interaction effects were removed one at a time. This analysis is for the HAMD6 change scores, reporting here information for Day 2.||||0.06
72495889|NCT03569202|144521389|OTHER||Mean Difference (Final Values)|-17.0625||||0.0038|TWO_SIDED|95.0|-27.928|-6.197||A two-sided p-value less than 0.05 was considered statistically significant.|ANOVA|||Within-group change from baseline||-6.1970|-27.9280|0.0038
72618999|NCT03615534|144768406|SUPERIORITY|||||||0.001||||||Results were evaluated in terms of adjusted end line FSG levels, embracing the least significant difference (LSD) for pair-wise comparison. Probability of less than 0.05 was considered statistically significant.|ANCOVA|Covariates appearing in ANCOVA model are evaluated at the following baseline values: FSG= 95.7 mg/dl.||Analysis of Covariance (ANCOVA), was applied to assess treatment effects among different arms, comprising the influence of the baseline FSG level as a covariate.||||0.001
72619000|NCT03615534|144768407|SUPERIORITY|||||||0.786||||||Results were evaluated in terms of adjusted end line eGFR levels, embracing the least significant difference (LSD) for pair-wise comparison. Probability of less than 0.05 was considered statistically significant.|ANCOVA|Covariates appearing in ANCOVA model are evaluated at the following baseline values: eGFR= 88.0 ml/min per 1.73 m\^2.||Analysis of Covariance (ANCOVA), was applied to assess treatment effects among different arms, comprising the influence of the baseline eGFR level as a covariate.||||0.786
72440050|NCT03149991|144393322|SUPERIORITY|We used contrast tests comparing brexpiprazole and placebo on the a priori specified days of interest.|Mean Difference (Final Values)|-0.23|STANDARD_ERROR_OF_MEAN|1.06||0.83|TWO_SIDED|||||Because these tests were conducted for secondary outcomes, p-values were not corrected for multiple testing.|Mixed Models Analysis||df = 44.2, t=-0.22|The same model building approach as used for the primary outcome variable was used for the secondary outcome variables. As per the primary outcome variable, the change scores (i.e., compared to baseline) were the dependent variables of interest. For each secondary outcome variable, non-significant site interaction effects were removed one at a time. This analysis is for the HAMD6 change scores, reporting here information for Day 14.||||0.83
72440051|NCT03149991|144393322|SUPERIORITY|We used contrast tests comparing brexpiprazole and placebo on the a priori specified days of interest.|Mean Difference (Final Values)|-0.77|STANDARD_ERROR_OF_MEAN|1.2||0.52|TWO_SIDED|||||Because these tests were conducted for secondary outcomes, p-values were not corrected for multiple testing.|Mixed Models Analysis||df =44.0, t=-0.64|The same model building approach as used for the primary outcome variable was used for the secondary outcome variables. As per the primary outcome variable, the change scores (i.e., compared to baseline) were the dependent variables of interest. For each secondary outcome variable, non-significant site interaction effects were removed one at a time. This analysis is for the HAMD6 change scores, reporting here information for Day 28.||||0.52
72440052|NCT03149991|144393322|SUPERIORITY|We used contrast tests comparing brexpiprazole and placebo on the a priori specified days of interest.|Mean Difference (Final Values)|0.31|STANDARD_ERROR_OF_MEAN|0.19||0.11|TWO_SIDED|||||Because these tests were conducted for secondary outcomes, p-values were not corrected for multiple testing.|Mixed Models Analysis||df = 31.0, t=1.67|The same model building approach as used for the primary outcome variable was used for the secondary outcome variables. As per the primary outcome variable, the change scores (i.e., compared to baseline) were the dependent variables of interest. For each secondary outcome variable, non-significant site interaction effects were removed one at a time. This analysis is for the CGI-S change scores, reporting here information for Day 2.||||0.11
72440053|NCT03149991|144393322|SUPERIORITY|We used contrast tests comparing brexpiprazole and placebo on the a priori specified days of interest.|Mean Difference (Net)|-0.01|STANDARD_ERROR_OF_MEAN|0.36||0.98|TWO_SIDED|||||Because these tests were conducted for secondary outcomes, p-values were not corrected for multiple testing.|Mixed Models Analysis||df=41.1, t=-0.03|The same model building approach as used for the primary outcome variable was used for the secondary outcome variables. As per the primary outcome variable, the change scores (i.e., compared to baseline) were the dependent variables of interest. For each secondary outcome variable, non-significant site interaction effects were removed one at a time. This analysis is for the CGI-S change scores, reporting here information for Day 14.||||0.98
72495890|NCT03569202|144521389|OTHER||Mean Difference (Final Values)|-15.0714||||0.0011|TWO_SIDED|95.0|-23.285|-6.8579||A two-sided p-value less than 0.05 was considered statistically significant.|ANOVA|||Within-group change from baseline||-6.8579|-23.2850|0.0011
72495891|NCT01175005|144521443|SUPERIORITY_OR_OTHER|||||||0.001|ONE_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.001
72495892|NCT02397473|144521444|SUPERIORITY||LSMean Difference|-3.47|STANDARD_ERROR_OF_MEAN|1.63||0.036|TWO_SIDED|95.0|-6.72|-0.23|||Mixed Models Analysis|||||-0.23|-6.72|0.036
72495893|NCT02397473|144521445|SUPERIORITY|||||||0.046|||||||ANCOVA|Koch's nonparametric randomization-based ANCOVA.||||||0.046
72495894|NCT02397473|144521446|SUPERIORITY||LSMean Difference|-0.83|STANDARD_ERROR_OF_MEAN|1.2||0.493|TWO_SIDED|95.0|-3.23|1.57|||Mixed Models Analysis|||||1.57|-3.23|0.493
72495895|NCT02397473|144521447|SUPERIORITY||Odds Ratio (OR)|3.046||||0.016|TWO_SIDED|95.0|1.242|7.469|||Mixed Models Analysis|||||7.469|1.242|0.016
72495896|NCT02397473|144521448|SUPERIORITY||Odds Ratio (OR)|1.312||||0.575|TWO_SIDED|95.0|0.502|3.426|||Mixed Models Analysis|||||3.426|.502|0.575
72495897|NCT02397473|144521449|SUPERIORITY||Odds Ratio (OR)|0.965||||0.91|TWO_SIDED|95.0|0.512|1.819|||Mixed Models Analysis|Pseudo-likelihood-based repeated measures.||||1.819|.512|0.910
72495898|NCT02397473|144521450|SUPERIORITY||Odds Ratio (OR)|0.929||||0.841|TWO_SIDED|95.0|0.449|1.923|||Mixed Models Analysis|Pseudolikelihood-based repeated measures model||||1.923|0.449|0.841
72495899|NCT01337973|144521456|SUPERIORITY||Coefficient estimate|0.82|||<|0.001|TWO_SIDED|95.0|0.37|1.84||The threshold for significance was p \< 0.05. Scores are reported stratified by whether they are less than .05 less than .01 and less than .001 respectively.|Wilcoxon Z|Wilcoxon Z value: -4.65|E-TAU arm is the referent group|Bivariate analyses examined change from baseline to follow up of primary and secondary outcomes measures using Wilcoxon sign rank tests. This test applies to overall physical aggression % change from baseline||1.84|0.37|<0.001
72495900|NCT01337973|144521456|SUPERIORITY||Coefficient Estimate|0.62|||<|0.01|TWO_SIDED|95.0|0.3|1.29||The threshold for significance was p \< 0.05. Scores are reported stratified by whether they are less than .05 less than .01 and less than .001 respectively.|Wilcoxon Z|Wilcoxon Z score: -2.83|E-TAU arm is the referent group|Bivariate analyses examined change from baseline to follow up of primary and secondary outcomes measures using Wilcoxon sign rank tests. This test applies to overall injury perpetration % change from baseline||1.29|0.30|<0.01
72495901|NCT01337973|144521456|SUPERIORITY||Coefficient Estimate|1.16|||<|0.01|TWO_SIDED|95.0|0.36|3.77||The threshold for significance was p \< 0.05. Scores are reported stratified by whether they are less than .05 less than .01 and less than .001 respectively.|Wilcoxon Z|Wilcoxon Z score: -3.31|E-TAU arm is the referent group|Bivariate analyses examined change from baseline to follow up of primary and secondary outcomes measures using Wilcoxon sign rank tests. This test applies to partner physical aggression % change from baseline||3.77|0.36|<0.01
72440054|NCT03149991|144393322|SUPERIORITY|We used contrast tests comparing brexpiprazole and placebo on the a priori specified days of interest.|Mean Difference (Final Values)|-0.31|STANDARD_ERROR_OF_MEAN|0.41||0.45|TWO_SIDED|||||Because these tests were conducted for secondary outcomes, p-values were not corrected for multiple testing.|Mixed Models Analysis||df=46.0, t=-0.76|The same model building approach as used for the primary outcome variable was used for the secondary outcome variables. As per the primary outcome variable, the change scores (i.e., compared to baseline) were the dependent variables of interest. For each secondary outcome variable, non-significant site interaction effects were removed one at a time. This analysis is for the CGI-S change scores, reporting here information for Day 28.||||0.45
72440055|NCT03149991|144393322|SUPERIORITY|We used contrast tests comparing brexpiprazole and placebo on the a priori specified days of interest. This model contains an interaction effect with site, because the SITE\*DRUG effect was significant (p=0.03).|Mean Difference (Final Values)|0.69|STANDARD_ERROR_OF_MEAN|0.29||0.02|TWO_SIDED|||||Because these tests were conducted for secondary outcomes, p-values were not corrected for multiple testing.|Mixed Models Analysis||df=49.2, t=2.39;|The same model building approach as used for the primary outcome variable was used for the secondary outcome variables. As per the primary outcome variable, the change scores (i.e., compared to baseline) were the dependent variables of interest. For each secondary outcome variable, non-significant site interaction effects were removed one at a time. This analysis is for the CGI-I change scores, reporting here information for Day 2.||||0.02
72440056|NCT03149991|144393322|SUPERIORITY|We used contrast tests comparing brexpiprazole and placebo on the a priori specified days of interest. This model contains an interaction effect with site, because the SITE\*DRUG effect was significant (p=0.03).|Mean Difference (Final Values)|0.63|STANDARD_ERROR_OF_MEAN|0.34||0.07|TWO_SIDED|||||Because these tests were conducted for secondary outcomes, p-values were not corrected for multiple testing.|Mixed Models Analysis||df=56.8, t=1.85|The same model building approach as used for the primary outcome variable was used for the secondary outcome variables. As per the primary outcome variable, the change scores (i.e., compared to baseline) were the dependent variables of interest. For each secondary outcome variable, non-significant site interaction effects were removed one at a time. This analysis is for the CGI-I change scores, reporting here information for Day 14.||||0.07
72440057|NCT03149991|144393322|SUPERIORITY|We used contrast tests comparing brexpiprazole and placebo on the a priori specified days of interest. This model contains an interaction effect with site, because the SITE\*DRUG effect was significant (p=0.03).|Mean Difference (Final Values)|0.37|STANDARD_ERROR_OF_MEAN|0.41||0.37|TWO_SIDED|||||Because these tests were conducted for secondary outcomes, p-values were not corrected for multiple testing.|Mixed Models Analysis||df=50.5, t=0.91|The same model building approach as used for the primary outcome variable was used for the secondary outcome variables. As per the primary outcome variable, the change scores (i.e., compared to baseline) were the dependent variables of interest. For each secondary outcome variable, non-significant site interaction effects were removed one at a time. This analysis is for the CGI-I change scores, reporting here information for Day 28.||||0.37
72440058|NCT03149991|144393326|EQUIVALENCE|The hypothesis was that there would be no group differences in terms of occurrence of abnormal ECGs.|Chi-squared test|0.28||||0.6|TWO_SIDED||||||Chi-squared|||This analysis was to assess group differences (drug vs. placebo) in terms of number of abnormal ECGs out of total ECGs assessed.||||0.60
72440059|NCT03149991|144393326|EQUIVALENCE|The hypothesis was that there would be no group differences in number/percentage of people with an abnormal ECG at baseline.|Chi-squared test|0.94||||0.33|TWO_SIDED||||||Chi-squared|||This analysis was to assess for group differences (drug vs. placebo) in number/percentage of people with an abnormal ECG at baseline.||||0.33
72440060|NCT03149991|144393326|EQUIVALENCE|The hypothesis was that there would be no group differences in number/percentage of people with an abnormal ECG at Visit 4.|Chi-squared test|0.0||||1|TWO_SIDED||||||Chi-squared|||This analysis was to assess for group differences (drug vs. placebo) in number/percentage of people with an abnormal ECG at Visit 4.||||1.00
72440061|NCT03149991|144393326|EQUIVALENCE|The hypothesis was that there would be no group differences in number/percentage of people with an abnormal ECG at Visit 5.|Chi-squared test|0.08||||0.78|TWO_SIDED||||||Chi-squared|||This analysis was to assess for group differences (drug vs. placebo) in number/percentage of people with an abnormal ECG at Visit 5.||||0.78
72440062|NCT03149991|144393326|EQUIVALENCE|The hypothesis was that there would be no group differences in number/percentage of people with an abnormal ECG at Visit 6.|Chi-squared test|0.02||||0.9|TWO_SIDED||||||Chi-squared|||This analysis was to assess for group differences (drug vs. placebo) in number/percentage of people with an abnormal ECG at Visit 6.||||0.90
72440063|NCT03149991|144393326|EQUIVALENCE|The hypothesis was that there would be no group differences in number/percentage of people with an abnormal ECG at Visit 7.|Chi-squared test|0.63||||0.43|TWO_SIDED||||||Chi-squared|||This analysis was to assess for group differences (drug vs. placebo) in number/percentage of people with an abnormal ECG at Visit 7.||||0.43
72440064|NCT03149991|144393326|EQUIVALENCE|The hypothesis was that there would be no group differences in number/percentage of people with an abnormal ECG at Visit 9.|Chi-squared test|0.09||||0.76|TWO_SIDED||||||Chi-squared|||This analysis was to assess for group differences (drug vs. placebo) in number/percentage of people with an abnormal ECG at Visit 9.||||0.76
72440065|NCT03149991|144393328|EQUIVALENCE|The hypothesis was that there would be no group differences in number of participants reporting adverse events.|Chi-squared test|0.009||||0.92|TWO_SIDED||||||Chi-squared|||This analysis assessed group differences (drug vs. placebo) in terms of number of participants reporting adverse events.||||0.92
72619001|NCT03615534|144768408|SUPERIORITY|||||||0.0001||||||Results were evaluated in terms of adjusted end line serum uric acid levels, embracing the least significant difference (LSD) for pair-wise comparison. Probability of less than 0.05 was considered statistically significant.|ANCOVA|Covariates appearing in ANCOVA model are evaluated at the following baseline values: serum uric acid= 5.0 mg/dl.||Analysis of Covariance (ANCOVA), was applied to assess treatment effects among different arms, comprising the influence of the baseline serum uric acid level as a covariate.||||0.0001
72440066|NCT03149991|144393329|EQUIVALENCE|The hypothesis was that there would be no difference between the groups in terms of mean number of adverse events per person, among those who reported any adverse events.|Mean Difference (Final Values)|0.24||||0.81|TWO_SIDED||||||t-test, 2 sided|||This analysis assessed group differences (drug vs. placebo) in terms of mean number of adverse events per person, among those who reported any adverse events.||||0.81
72495902|NCT01337973|144521456|SUPERIORITY||Coefficient Estimate|0.51|||<|0.05|TWO_SIDED|95.0|0.19|1.38||The threshold for significance was p \< 0.05. Scores are reported stratified by whether they are less than .05 less than .01 and less than .001 respectively.|Wilcoxon Z|Wilcoxon Z score: -2.26|E-TAU arm is the referent group|Bivariate analyses examined change from baseline to follow up of primary and secondary outcomes measures using Wilcoxon sign rank tests. This test applies to partner injury % change from baseline||1.38|0.19|<0.05
72495903|NCT01337973|144521456|SUPERIORITY||Coefficient Estimate|1.22|||<|0.001|TWO_SIDED|95.0|0.66|2.28||The threshold for significance was p \< 0.05. Scores are reported stratified by whether they are less than .05 less than .01 and less than .001 respectively.|Wilcoxon Z|Wilcoxon Z score: -3.79|E-TAU arm is the referent group|Bivariate analyses examined change from baseline to follow up of primary and secondary outcomes measures using Wilcoxon sign rank tests. This test applies to non-partner physical aggression % change from baseline||2.28|0.66|<0.001
72495904|NCT01337973|144521456|SUPERIORITY||Coefficient Estimate|0.8|||<|0.05|TWO_SIDED|95.0|0.32|1.98||The threshold for significance was p \< 0.05. Scores are reported stratified by whether they are less than .05 less than .01 and less than .001 respectively.|Wilcoxon Z|Wilcoxon Z score: -2.01|E-TAU arm is the referent group|Bivariate analyses examined change from baseline to follow up of primary and secondary outcomes measures using Wilcoxon sign rank tests. This test applies to non-partner injury % change from baseline||1.98|0.32|<0.05
72559087|NCT01243151|144647860|SUPERIORITY_OR_OTHER||LS Mean Difference|-49.94|STANDARD_ERROR_OF_MEAN|4.312|<|0.0001|TWO_SIDED|95.0|-58.58|-41.31|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-41.31|-58.58|<0.0001
72440067|NCT03149991|144393330|EQUIVALENCE|The hypothesis was that there would be no group differences in occurrence of suicidal ideation.|Chi-squared test|0.43||||0.51|TWO_SIDED||||||Chi-squared|||This analysis was to compare by group (drug vs. placebo) the occurrence of suicidal ideation (endorsement of item 1 on the CHRT) throughout the trial.||||0.51
72440068|NCT03149991|144393330|EQUIVALENCE|The hypothesis was that there would be no group differences in occurrence of suicidal ideation.|Chi-squared|2.85||||0.09|TWO_SIDED||||||Chi-squared|||This analysis was to compare by group (drug vs. placebo) the occurrence of suicidal ideation (endorsement of item 1 on the CHRT) at Screening.||||0.09
72440069|NCT03149991|144393330|EQUIVALENCE|The hypothesis was that there would be no group differences in occurrence of suicidal ideation.|Chi-squared|0.004||||0.95|TWO_SIDED||||||Chi-squared|||This analysis was to compare by group (drug vs. placebo) the occurrence of suicidal ideation (endorsement of item 1 on the CHRT) at Baseline.||||0.95
72440070|NCT03149991|144393330|EQUIVALENCE|The hypothesis was that there would be no group differences in occurrence of suicidal ideation.|Chi-squared|0.005||||0.94|TWO_SIDED||||||Chi-squared|||This analysis was to compare by group (drug vs. placebo) the occurrence of suicidal ideation (endorsement of item 1 on the CHRT) on Day 1.||||0.94
72440071|NCT03149991|144393330|EQUIVALENCE|The hypothesis was that there would be no group differences in occurrence of suicidal ideation.|Chi-squared|1.97||||0.16|TWO_SIDED||||||Chi-squared|||This analysis was to compare by group (drug vs. placebo) the occurrence of suicidal ideation (endorsement of item 1 on the CHRT) on Day 2.||||0.16
72440072|NCT03149991|144393330|EQUIVALENCE|The hypothesis was that there would be no group differences in occurrence of suicidal ideation.|Chi-squared|0.44||||0.51|TWO_SIDED||||||Chi-squared|||This analysis was to compare by group (drug vs. placebo) the occurrence of suicidal ideation (endorsement of item 1 on the CHRT) on Day 5.||||0.51
72440073|NCT03149991|144393330|EQUIVALENCE|The hypothesis was that there would be no group differences in occurrence of suicidal ideation.|Chi-squared|0.94||||0.33|TWO_SIDED||||||Chi-squared|||This analysis was to compare by group (drug vs. placebo) the occurrence of suicidal ideation (endorsement of item 1 on the CHRT) on Day 8.||||0.33
72440074|NCT03149991|144393330|EQUIVALENCE|The hypothesis was that there would be no group differences in occurrence of suicidal ideation.|Chi-squared|0.003||||0.96|TWO_SIDED||||||Chi-squared|||This analysis was to compare by group (drug vs. placebo) the occurrence of suicidal ideation (endorsement of item 1 on the CHRT) on Day 11.||||0.96
72440075|NCT03149991|144393330|EQUIVALENCE|The hypothesis was that there would be no group differences in occurrence of suicidal ideation.|Chi-squared|0.5||||0.48|TWO_SIDED||||||Chi-squared|||This analysis was to compare by group (drug vs. placebo) the occurrence of suicidal ideation (endorsement of item 1 on the CHRT) on Day 14.||||0.48
72440076|NCT03149991|144393330|EQUIVALENCE|The hypothesis was that there would be no group differences in occurrence of suicidal ideation.|Chi-squared|0.67||||0.41|TWO_SIDED||||||Chi-squared|||This analysis was to compare by group (drug vs. placebo) the occurrence of suicidal ideation (endorsement of item 1 on the CHRT) on Day 17.||||0.41
72440077|NCT03149991|144393330|EQUIVALENCE|The hypothesis was that there would be no group differences in occurrence of suicidal ideation.|Chi-squared|0.17||||0.68|TWO_SIDED||||||Chi-squared|||This analysis was to compare by group (drug vs. placebo) the occurrence of suicidal ideation (endorsement of item 1 on the CHRT) on Day 21.||||0.68
72495905|NCT01337973|144521456|SUPERIORITY||Coefficient Estimate|0.6|||<|0.001|TWO_SIDED|95.0|0.25|1.46||The threshold for significance was p \< 0.05. Scores are reported stratified by whether they are less than .05 less than .01 and less than .001 respectively.|Wilcoxon Z|Wilcoxon Z score: -4.81|E-TAU arm is the referent group|Bivariate analyses examined change from baseline to follow up of primary and secondary outcomes measures using Wilcoxon sign rank tests. This test applies to overall physical aggression % change from baseline||1.46|0.25|<0.001
72495906|NCT01337973|144521456|SUPERIORITY||Coefficient Estimate|1.05|||<|0.001|TWO_SIDED|95.0|0.45|2.44||The threshold for significance was p \< 0.05. Scores are reported stratified by whether they are less than .05 less than .01 and less than .001 respectively.|Wilcoxon Z|Wilcoxon Z score: -3.74|E-TAU arm is the referent group|Bivariate analyses examined change from baseline to follow up of primary and secondary outcomes measures using Wilcoxon sign rank tests. This test applies to overall injury perpetration % change from baseline||2.44|0.45|<0.001
72619002|NCT03615534|144768409|OTHER|||||||0.201||||||Results were evaluated in terms of adjusted end line AST levels, embracing the least significant difference (LSD) for pair-wise comparison. Probability of less than 0.05 was considered statistically significant.|ANCOVA|"Covariates appearing in ANCOVA model are evaluated at the following baseline values: AST= 18.1 IU/L.~."||Analysis of Covariance (ANCOVA), was applied to assess treatment effects among different arms, comprising the influence of the baseline AST level as a covariate.||||0.201
72440078|NCT03149991|144393330|EQUIVALENCE|The hypothesis was that there would be no group differences in occurrence of suicidal ideation.|Chi-squared|0.67||||0.41|TWO_SIDED||||||Chi-squared|||This analysis was to compare by group (drug vs. placebo) the occurrence of suicidal ideation (endorsement of item 1 on the CHRT) on Day 23.||||0.41
72440079|NCT03149991|144393330|EQUIVALENCE|The hypothesis was that there would be no group differences in occurrence of suicidal ideation.|Chi-squared|0.67||||0.41|TWO_SIDED||||||Chi-squared|||This analysis was to compare by group (drug vs. placebo) the occurrence of suicidal ideation (endorsement of item 1 on the CHRT) on Day 28.||||0.41
72440080|NCT03546608|144393331|OTHER||Ratio of Geometric Least Square Mean (%)|94.99|||||TWO_SIDED|90.0|64.75|139.35||||||||139.35|64.75|
72440081|NCT03546608|144393331|OTHER||Ratio of Geometric Least Square Mean (%)|87.92|||||TWO_SIDED|90.0|59.93|128.98||||||||128.98|59.93|
72440082|NCT03546608|144393332|OTHER||Ratio of Geometric Least Square Mean (%)|94.81|||||TWO_SIDED|90.0|64.09|140.26||||||||140.26|64.09|
72440083|NCT03546608|144393332|OTHER||Ratio of Geometric Least Square Mean (%)|87.2|||||TWO_SIDED|90.0|58.94|129.0||||||||129.00|58.94|
72440084|NCT03546608|144393333|OTHER||Ratio of Geometric Least Square Mean (%)|102.45|||||TWO_SIDED|90.0|80.9|129.73||||||||129.73|80.90|
72440085|NCT03546608|144393333|OTHER||Ratio of Geometric Least Square Mean (%)|71.02|||||TWO_SIDED|90.0|56.08|89.93||||||||89.93|56.08|
72440086|NCT03546608|144393344|OTHER||Ratio of Geometric Least Square Mean (%)|82.62|||||TWO_SIDED|90.0|45.67|149.47|||||For MSC2571109|||149.47|45.67|
72440087|NCT03546608|144393344|OTHER||Ratio of Geometric Least Square Mean (%)|136.59|||||TWO_SIDED|90.0|75.5|247.12|||||For MSC2571109|||247.12|75.50|
72440088|NCT03546608|144393344|OTHER||Ratio of Geometric Least Square Mean (%)|100.47|||||TWO_SIDED|90.0|54.53|185.1|||||For MSC2571107|||185.10|54.53|
72440089|NCT03546608|144393344|OTHER||Ratio of Geometric Least Square Mean (%)|94.48|||||TWO_SIDED|90.0|51.28|174.07|||||For MSC2571107|||174.07|51.28|
72440090|NCT03546608|144393345|OTHER||Ratio of Geometric Least Square Mean (%)|82.35|||||TWO_SIDED|90.0|45.56|148.84|||||For MSC2571109|||148.84|45.56|
72440091|NCT03546608|144393345|OTHER||Ratio of Geometric Least Square Mean (%)|137.51|||||TWO_SIDED|90.0|76.08|248.54|||||For MSC2571109|||248.54|76.08|
72440092|NCT03546608|144393345|OTHER||Ratio of Geometric Least Square Mean (%)|100.81|||||TWO_SIDED|90.0|55.16|184.23|||||For MSC2571107|||184.23|55.16|
72440093|NCT03546608|144393345|OTHER||Ratio of Geometric Least Square Mean (%)|96.18|||||TWO_SIDED|90.0|52.63|175.78|||||For MSC2571107|||175.78|52.63|
72440094|NCT03546608|144393346|OTHER||Ratio of Geometric Least Square Mean (%)|92.3|||||TWO_SIDED|90.0|62.52|136.26|||||For MSC2571109|||136.26|62.52|
72440095|NCT03546608|144393346|OTHER||Ratio of Geometric Least Square Mean (%)|114.8|||||TWO_SIDED|90.0|77.76|169.48|||||For MSC2571109|||169.48|77.76|
72440096|NCT03546608|144393346|OTHER||Ratio of Geometric Least Square Mean (%)|106.51|||||TWO_SIDED|90.0|70.25|161.49|||||For MSC2571107|||161.49|70.25|
72440097|NCT03546608|144393346|OTHER||Ratio of Geometric Least Square Mean (%)|72.58|||||TWO_SIDED|90.0|47.87|110.04|||||For MSC2571107|||110.04|47.87|
72440098|NCT03785782|144393421|OTHER|||||||0.2988|||||||Regression, Logistic|||||||0.2988
72440099|NCT03785782|144393422|OTHER|||||||0.36|||||||Regression, Linear|||||||0.36
72440100|NCT03785782|144393423|OTHER|||||||0.43|||||||Regression, Linear|||||||0.43
72440101|NCT03785782|144393424|OTHER|||||||0.42|||||||Regression, Linear|||||||0.42
72440102|NCT03785782|144393425|OTHER|||||||0.45|||||||Regression, Linear|||||||0.45
72440103|NCT03785782|144393426|OTHER|||||||0.18|||||||Regression, Linear|||||||0.18
72440104|NCT03785782|144393427|OTHER|||||||0.78|||||||Regression, Linear|||||||0.78
72440105|NCT03785782|144393428|OTHER|||||||0.45|||||||Regression, Linear|||||||0.45
72440106|NCT03785782|144393429|OTHER|||||||0.34|||||||Regression, Linear|||||||0.34
72440107|NCT03785782|144393430|OTHER|||||||0.7465|||||||Regression, Logistic|||||||0.7465
72440108|NCT03785782|144393431|OTHER|||||||0.0466|||||||Regression, Logistic|||||||0.0466
72440109|NCT03785782|144393432|OTHER|||||||0.1567|||||||Regression, Logistic|||||||0.1567
72440110|NCT03785782|144393433|OTHER|||||||0.1837|||||||Regression, Logistic|||||||0.1837
72440111|NCT03785782|144393434|OTHER|||||||0.7447|||||||Regression, Logistic|||||||0.7447
72440112|NCT03785782|144393435|OTHER|||||||0.0739|||||||Regression, Logistic|||||||0.0739
72440113|NCT03785782|144393436|OTHER|||||||0.9995|||||||Regression, Logistic|||||||0.9995
72440114|NCT03779048|144393439|OTHER|Regression using baseline scores to predict 4-week weight loss during the behavioral treatment run-in. Primary prediction analysis presented below was pre-specified to evaluate together postprandial satiety, postprandial increases in GLP-1 and gastric emptying (acetaminophen tests) and includes only the 125 participants from whom baseline blood samples could be obtained.|Standardized Beta coefficient|0.11||||0.24|TWO_SIDED||||||Regression, Linear|Controls for postprandial increases in GLP-1 and gastric emptying (acetaminophen tests)||||||.24
72440115|NCT03779048|144393440|OTHER|Regression using baseline scores to predict 4-week weight loss during the behavioral treatment run-in. Primary prediction analysis presented below was pre-specified to evaluate together postprandial satiety, postprandial increases in GLP-1 and gastric emptying (acetaminophen tests) and includes only the 125 participants from whom baseline blood samples could be obtained.|Standardized Beta coefficient|-0.09||||0.34|TWO_SIDED||||||Regression, Linear|Controls for baseline postprandial satiety and gastric emptying (acetaminophen test)||||||.34
72440116|NCT03779048|144393441|OTHER|Regression using baseline scores to predict 4-week weight loss during the behavioral treatment run-in. Primary prediction analysis presented below was pre-specified to evaluate together postprandial satiety, postprandial increases in GLP-1 and gastric emptying (acetaminophen tests) and includes only the 125 participants from whom baseline blood samples could be obtained.|Standardized Beta coefficient|0.03||||0.78|TWO_SIDED||||||Regression, Linear|Controls for baseline postprandial satiety and postprandial change in GLP-1||||||.78
72440117|NCT03779048|144393442|SUPERIORITY||Mean Difference (Final Values)|3.1|STANDARD_ERROR_OF_MEAN|1.0||0.003|TWO_SIDED|95.0|1.1|5.1|||Mixed Models Analysis|||||5.1|1.1|.003
72440118|NCT03779048|144393443|OTHER|Correlation between baseline postprandial hunger AUC and 4-week percent weight loss.|r|-0.1||||0.23|TWO_SIDED||||||Regression, Linear|||||||.23
72440119|NCT03779048|144393444|OTHER|Correlation between baseline high energy density food reinforcer points earned and 4-week percent weight loss.|r|-0.1||||0.23|TWO_SIDED||||||Regression, Linear|||||||.23
72440120|NCT03779048|144393445|OTHER|Regression results using baseline AUC for delay discounting to predict 4-week percent weight loss, controlling for participant age.|r2 change|0.033||||0.033|TWO_SIDED||||||Regression, Linear|||||||.033
72440121|NCT03779048|144393446|OTHER|Correlation between baseline implicit wanting and 4-week percent weight loss. Because categories are scored relative to each other they cannot be included together in the same analysis, so separate correlations were conducted.|r|0.17||||0.04|TWO_SIDED|||||Correlation to Implicit wanting of High Fat Savory.|Regression, Linear|||||||.04
72440122|NCT03779048|144393446|OTHER|Correlation to Implicit wanting of Low Fat Savory.|r|-0.03||||0.72|TWO_SIDED||||||Regression, Linear|||Correlation between baseline implicit wanting and 4-week percent weight loss. Because categories are scored relative to each other they cannot be included taughter in the same analysis, so separate correlations were conducted.||||.72
72440123|NCT03779048|144393446|OTHER|Correlation to Implicit wanting of High Fat Sweet.|r|0.01||||0.94|TWO_SIDED||||||Regression, Linear|||Correlation between baseline implicit wanting and 4-week percent weight loss. Because categories are scored relative to each other they cannot be included together in the same analysis, so separate correlations were conducted.||||.94
72440124|NCT03779048|144393446|OTHER|Correlation to Implicit wanting of Low Fat Sweet.|r|-0.15||||0.09|TWO_SIDED||||||Regression, Linear|||Correlation between baseline implicit wanting and 4-week percent weight loss. Because categories are scored relative to each other they cannot be included together in the same analysis, so separate correlations were conducted.||||.09
72440125|NCT03779048|144393447|OTHER|Correlation between baseline fasting active ghrelin and 4-week percent weight loss.|r|0.03||||0.73|TWO_SIDED||||||Regression, Linear|||||||.73
72440126|NCT03779048|144393448|OTHER||r|-0.1||||0.25|TWO_SIDED||||||Regression, Linear|||Correlation between baseline fasting leptin and 4-week percent weight loss.||||.25
72440127|NCT03779048|144393449|OTHER|Correlation between baseline postprandial AUC for change in insulin and 4-week percent weight loss.|r|-0.03||||0.72|TWO_SIDED||||||Regression, Linear|||||||.72
72440128|NCT03779048|144393450|OTHER|Correlation between baseline postprandial incremental AUC for PYY and 4-week percent weight loss.|r|-0.02||||0.82|TWO_SIDED||||||Regression, Linear|||||||.82
72440129|NCT03779048|144393451|SUPERIORITY||Mean Difference (Final Values)|3.1||||0.002|TWO_SIDED|95.0|1.1|5.0|||Mixed Models Analysis|||||5.0|1.1|.002
72440130|NCT03779048|144393456|SUPERIORITY|Difference between placebo- and phentermine-treated participants in change in delay discounting area under the curve from randomization to week 24 was calculated using repeated measures ANCOVA, controlling for age.|F|0.17||||0.68|TWO_SIDED||||||ANCOVA|||||||.68
72495907|NCT01337973|144521456|SUPERIORITY||Coefficient Estimate|0.48|||<|0.01|TWO_SIDED|95.0|0.13|1.78||The threshold for significance was p \< 0.05. Scores are reported stratified by whether they are less than .05 less than .01 and less than .001 respectively.|Wilcoxon Z|Wilcoxon Z score: -2.59|E-TAU arm is the referent group|Bivariate analyses examined change from baseline to follow up of primary and secondary outcomes measures using Wilcoxon sign rank tests. This test applies to partner physical aggression % change from baseline||1.78|0.13|<0.01
72559088|NCT01243151|144647861|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.52|STANDARD_ERROR_OF_MEAN|19.581||0.9789|TWO_SIDED|95.0|-39.08|38.04|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||38.04|-39.08|0.9789
72440131|NCT03779048|144393457|OTHER|Regression using the three Eating Inventory subscales (Cognitive restraint, disinhibition, hunger) to predict 4-week weight loss|r2|0.01||||0.75|TWO_SIDED|||||For full model including all 3 predictors|Regression, Linear|||||||.75
72440132|NCT03779048|144393458|OTHER|Correlation between baseline past-week appetite and 4-week percent weight loss.|r|-0.09||||0.31|TWO_SIDED||||||Regression, Linear|||||||.31
72440133|NCT03779048|144393460|OTHER|Regression using baseline scores for Behavioral Inhibition (BIS) and Behavioral Activation fro Reward to predict 4-week weight loss during the behavioral treatment run-in.|r2|0.05||||0.03|TWO_SIDED||||||Regression, Linear|||||||.03
72440134|NCT03779048|144393461|OTHER|Correlation between baseline BIS-15 total score and 4-week percent weight loss.|r|0.03||||0.76|TWO_SIDED||||||Regression, Linear|||||||.76
72440135|NCT05777785|144393485|SUPERIORITY|Power analysis determined that a sample size of 90 participants will have 80% power to detect an effect size of 0.30 (Cohen's D) using a paired t-test with a 0.05 two-sided significance level.|Mean Difference (Final Values)|0.9789||||0.037|TWO_SIDED||||||t-test, 2 sided|||||||0.037
72440136|NCT05777785|144393487|SUPERIORITY|Power analysis determined that a sample size of 90 participants will have 80% power to detect an effect size of 0.30 (Cohen's D) using a paired t-test with a 0.05 two-sided significance level.|Mean Difference (Final Values)|2.09||||0.027|TWO_SIDED||||||t-test, 2 sided|||||||0.027
72440137|NCT05777785|144393488|SUPERIORITY|Power analysis determined that a sample size of 90 participants will have 80% power to detect an effect size of 0.30 (Cohen's D) using a paired t-test with a 0.05 two-sided significance level.|Mean Difference (Final Values)|2.09||||0.029|TWO_SIDED||||||t-test, 2 sided|||||||0.029
72469438|NCT04750577|144462631|OTHER|MMRM estimates were used as input for the MCP-Mod. including the fixed, categorical effects of treatment at each visit (baseline, Week 6, Week 12 and Week 20), and the continuous effect of baseline at each visit as well as random effects of patient.||||||0.0586|||||||MCP-Mod Emax model fit|Model assumption: 80% of the maximum effect is achieved at 6 mg.||A flat vs. non-flat dose-response relationship across the 3 doses of BI 685509 and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, exponential, quadratic, Emax and Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.050). The total daily dose was considered for MCP-Mod analysis (placebo, active BI 685509 3 mg, 6 mg, and 9 mg).||||0.0586
72559089|NCT01243151|144647861|SUPERIORITY_OR_OTHER||LS Mean Difference|-11.94|STANDARD_ERROR_OF_MEAN|20.069||0.5525|TWO_SIDED|95.0|-51.46|27.59|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||27.59|-51.46|0.5525
72440138|NCT04588259|144393495|NON_INFERIORITY|The upper limit of the 95% confidence interval (CI) for the difference between faster aspart and NovoRapid was compared to a non-inferiority margin of 0.4%. If it was below or equal to 0.4%, non-inferiority was considered to be established and effect demonstrated.|Treatment difference|-0.05||||0.5102|TWO_SIDED|95.0|-0.19|0.09||p-values are from the 2-sided test for treatment difference evaluated at the 5% level.|Mixed Models Analysis|||The outcome measure was analysed using mixed-effect model for repeated measurement (MMRM) where all calculated changes in HbA1c from baseline at visits were included in analysis. Model included treatment and stratification of type 1 diabetes mellitus/ type 2 diabetes mellitus (T1DM/T2DM) as fixed factors, HbA1c at baseline as covariate and interactions between all fixed factors and visit. An unstructured covariance matrix described the variability for the repeated measurements for a participant.||0.09|-0.19|0.5102
72495908|NCT01337973|144521456|SUPERIORITY||Coefficient Estimate|0.48|||>|0.05|TWO_SIDED|95.0|0.16|1.47||The threshold for significance was p \< 0.05. Scores are reported stratified by whether they are less than .05 less than .01 and less than .001 respectively.|Wilcoxon Z|Wilcoxon Z score: -1.81|E-TAU arm is the referent group|Bivariate analyses examined change from baseline to follow up of primary and secondary outcomes measures using Wilcoxon sign rank tests. This test applies to partner injury % change from baseline||1.47|0.16|>0.05
72495909|NCT01337973|144521456|SUPERIORITY||Coefficient Estimate|1.12|||<|0.001|TWO_SIDED|95.0|0.6|2.08||The threshold for significance was p \< 0.05. Scores are reported stratified by whether they are less than .05 less than .01 and less than .001 respectively.|Wilcoxon Z|Wilcoxon Z score: -4.10|E-TAU arm is the referent group|Bivariate analyses examined change from baseline to follow up of primary and secondary outcomes measures using Wilcoxon sign rank tests. This test applies to non-partner physical aggression % change from baseline||2.08|0.60|<0.001
72495910|NCT01337973|144521456|SUPERIORITY||Coefficient Estimate|1.09|||<|0.01|TWO_SIDED|95.0|0.4|2.95||The threshold for significance was p \< 0.05. Scores are reported stratified by whether they are less than .05 less than .01 and less than .001 respectively.|Wilcoxon Z|Wilcoxon Z score: -3.17|E-TAU arm is the referent group|Bivariate analyses examined change from baseline to follow up of primary and secondary outcomes measures using Wilcoxon sign rank tests. This test applies to non-partner injury % change from baseline||2.95|0.40|<0.01
72495911|NCT01337973|144521456|SUPERIORITY||||||<|0.001||||||The threshold for significance was p \< 0.05. Scores are reported stratified by whether they are less than .05 less than .01 and less than .001 respectively.|Wilcoxon Z|Wilcoxon Z score: -4.69||Bivariate analyses examined change from baseline to follow up of primary and secondary outcomes measures using Wilcoxon sign rank tests. This test applies to overall physical aggression % change from baseline||||<0.001
72495912|NCT01337973|144521456|SUPERIORITY||||||<|0.01||||||The threshold for significance was p \< 0.05. Scores are reported stratified by whether they are less than .05 less than .01 and less than .001 respectively.|Wilcoxon Z|Wilcoxon Z score: -3.32||Bivariate analyses examined change from baseline to follow up of primary and secondary outcomes measures using Wilcoxon sign rank tests. This test applies to overall injury % change from baseline||||<0.01
72495913|NCT01337973|144521456|SUPERIORITY||||||<|0.01||||||The threshold for significance was p \< 0.05. Scores are reported stratified by whether they are less than .05 less than .01 and less than .001 respectively.|Wilcoxon Z|Wilcoxon Z score: -2.90||Bivariate analyses examined change from baseline to follow up of primary and secondary outcomes measures using Wilcoxon sign rank tests. This test applies to partner physical aggression % change from baseline||||<0.01
72495914|NCT01337973|144521456|SUPERIORITY||||||>|0.05||||||The threshold for significance was p \< 0.05. Scores are reported stratified by whether they are less than .05 less than .01 and less than .001 respectively.|Wilcoxon Z|Wilcoxon Z Score: -1.02||Bivariate analyses examined change from baseline to follow up of primary and secondary outcomes measures using Wilcoxon sign rank tests. This test applies to partner injury % change from baseline||||>0.05
72495915|NCT01337973|144521456|SUPERIORITY||||||<|0.01||||||The threshold for significance was p \< 0.05. Scores are reported stratified by whether they are less than .05 less than .01 and less than .001 respectively.|Wilcoxon Z|Wilcoxon Z Score: -4.01||Bivariate analyses examined change from baseline to follow up of primary and secondary outcomes measures using Wilcoxon sign rank tests. This test applies to non-partner physical aggression % change from baseline||||<0.01
72495916|NCT01337973|144521456|SUPERIORITY||||||<|0.01||||||The threshold for significance was p \< 0.05. Scores are reported stratified by whether they are less than .05 less than .01 and less than .001 respectively.|Wilcoxon Z|Wilcoxon Z score: -3.21||Bivariate analyses examined change from baseline to follow up of primary and secondary outcomes measures using Wilcoxon sign rank tests. This test applies to overall non-partner injury % change from baseline||||<0.01
72495917|NCT01337973|144521457|SUPERIORITY||Coefficient estimate|0.95|||<|0.001|TWO_SIDED|95.0|0.62|1.47||The threshold for significance was p\<0.05. Scores are reported stratified by whether they are less than 0.05, less than 0.01, and less than 0.001.|Wilcoxon Z|Wilcoxon Z value: -3.52|E-TAU arm is the referent group|"Bivariate analyses examined change from baseline to follow up of substance use outcomes measures using Wilcoxon sign rank tests.~This test applies to heavy drinking % change from baseline"||1.47|0.62|<0.001
72495918|NCT01337973|144521457|SUPERIORITY||coefficient estimate|0.49|||<|0.01|TWO_SIDED|95.0|0.18|1.32||The threshold for significance was p\<0.05. Scores are reported stratified by whether they are less than 0.05, less than 0.01, and less than 0.001.|Wilcoxon Z|Wilcoxon Z value: -2.98|E-TAU arm is the referent group|"Bivariate analyses examined change from baseline to follow up of substance use outcomes measures using Wilcoxon sign rank tests.~This test applies to cocaine use % change from baseline"||1.32|0.18|<0.01
72504750|NCT03114969|144540501|SUPERIORITY||Odds Ratio (OR)|2.409||||0.122|TWO_SIDED|95.0|0.792|7.331||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator.|||7.331|0.792|0.122
72504751|NCT03114969|144540502|SUPERIORITY||Odds Ratio (OR)|4.887||||0.001|TWO_SIDED|95.0|1.851|12.903||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator.|||12.903|1.851|0.001
72440139|NCT04588259|144393496|NON_INFERIORITY|The upper limit of the 95% CI for the difference between faster aspart and NovoRapid was compared to a non-inferiority margin of 0.4%. If it was below or equal to 0.4%, non-inferiority was considered to be established and effect demonstrated.|Treatment Difference|-0.52||||0.5102|TWO_SIDED|95.0|-2.08|1.03||p-values are from the 2-sided test for treatment difference evaluated at the 5% level.|Mixed Models Analysis|||The outcome measure was analysed using a mixed-effect model for repeated measurements (MMRM) where all calculated changes in HbA1c from baseline at visits are included in the analysis. The model includes treatment and stratification (T1DM/T2DM) as fixed factors, HbA1c at baseline as covariate and interactions between all fixed factors and visit. An unstructured covariance matrix is used to describe the variability for the repeated measurements for a participant.||1.03|-2.08|0.5102
72440140|NCT01164098|144393525|SUPERIORITY|||||||0.18|||||||t-test, 2 sided|Using Natural Log Transformed Data||T-test of the natural logarithmic transformed data||||0.18
72440141|NCT01164098|144393526|SUPERIORITY|||||||0.49|||||||t-test, 2 sided|||T-test of Natural Log Transformed Data.||||0.49
72440142|NCT01164098|144393527|SUPERIORITY|||||||0.37|||||||t-test, 2 sided|||T-test||||0.37
72440143|NCT00232180|144393528|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.63|||<|0.0001|TWO_SIDED|95.0|0.535|0.741||Using an adaptation of Haybittle-Peto stopping criterion adjusting for two interim analyses, p-value for final primary analysis will be compared to alpha=0.049. No adjustment in alpha will be made on parameters/endpoints other than primary endpoint.|Cox proportional hazard model|||Cox proportional hazard model includes treatment as the major factor, adjusting for age, estimated glomerular filtration rate, left ventricular ejection fraction, body mass index, hemoglobin, heart rate, systolic blood pressure, diabetes, history of hypertension, prior myocardial infarction, baseline left bundle branch block, time from electrocardiogram Q wave to the end of the S wave corresponding to ventricle depolarization (QRS) and atrial fibrillation as covariates.||0.741|0.535|<0.0001
72440144|NCT00232180|144393530|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.647|||<|0.0001|TWO_SIDED|95.0|0.552|0.757||Statistically significant if p-value \<0.01|Cox proportional hazard model|||The statistical analysis was only performed on the adjudicated endpoint data up to cut-off. Cox proportional hazard model includes treatment as the major factor, adjusting for age, estimated glomerular filtration rate, left ventricular ejection fraction, body mass index, hemoglobin, heart rate, systolic blood pressure, diabetes, history of hypertension, prior myocardial infarction, baseline left bundle branch block, QRS complex and atrial fibrillation as covariates.||0.757|0.552|<0.0001
72440145|NCT00232180|144393531|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.761||||0.0081|TWO_SIDED|95.0|0.622|0.932||Statistically significant if p-value \<0.01|Cox proportional hazard model|||The statistical analysis was only performed on the adjudicated endpoint data up to cut-off. Cox proportional hazard model includes treatment as the major factor, adjusting for age, estimated glomerular filtration rate, left ventricular ejection fraction, body mass index, hemoglobin, heart rate, systolic blood pressure, diabetes, history of hypertension, prior myocardial infarction, baseline left bundle branch block, QRS complex and atrial fibrillation as covariates.||0.932|0.622|0.0081
72440146|NCT00232180|144393532|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.757||||0.012|TWO_SIDED|95.0|0.609|0.941||Statistically significant if p-value \<0.01|Cox proportional hazard model|||The statistical analysis was only performed on the adjudicated endpoint data up to cut-off. Cox proportional hazard model includes treatment as the major factor, adjusting for age, estimated glomerular filtration rate, left ventricular ejection fraction, body mass index, hemoglobin, heart rate, systolic blood pressure, diabetes, history of hypertension, prior myocardial infarction, baseline left bundle branch block, QRS complex and atrial fibrillation as covariates.||0.941|0.609|0.0120
72559090|NCT01243151|144647861|SUPERIORITY_OR_OTHER||LS Mean Difference|-13.39|STANDARD_ERROR_OF_MEAN|19.979||0.5035|TWO_SIDED|95.0|-52.73|25.96|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||25.96|-52.73|0.5035
72440147|NCT00232180|144393533|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.768|||<|0.0001|TWO_SIDED|95.0|0.673|0.876||Statistically significant if p-value \<0.01|Cox proportional hazard model|||The statistical analysis was only performed on the adjudicated endpoint data up to cut-off. Cox proportional hazard model includes treatment as the major factor, adjusting for age, estimated glomerular filtration rate, left ventricular ejection fraction, body mass index, hemoglobin, heart rate, systolic blood pressure, diabetes, history of hypertension, prior myocardial infarction, baseline left bundle branch block, QRS complex and atrial fibrillation as covariates.||0.876|0.673|<0.0001
72440148|NCT00232180|144393534|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.576|||<|0.0001|TWO_SIDED|95.0|0.473|0.702||Statistically significant if p-value \<0.01|Cox proportional hazard model|||The statistical analysis was only performed on the adjudicated endpoint data up to cut-off. Cox proportional hazard model includes treatment as the major factor, adjusting for age, estimated glomerular filtration rate, left ventricular ejection fraction, body mass index, hemoglobin, heart rate, systolic blood pressure, diabetes, history of hypertension, prior myocardial infarction, baseline left bundle branch block, QRS complex and atrial fibrillation as covariates.||0.702|0.473|<0.0001
72440149|NCT00232180|144393535|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.751|||<|0.0001|TWO_SIDED|95.0|0.664|0.849||Statistically significant if p-value \<0.01|Cox proportional hazard model|||The statistical analysis was only performed on the adjudicated endpoint data up to cut-off. Cox proportional hazard model includes treatment as the major factor, adjusting for age, estimated glomerular filtration rate, left ventricular ejection fraction, body mass index, hemoglobin, heart rate, systolic blood pressure, diabetes, history of hypertension, prior myocardial infarction, baseline left bundle branch block, QRS complex and atrial fibrillation as covariates.||0.849|0.664|<0.0001
72559091|NCT01243151|144647861|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.21|STANDARD_ERROR_OF_MEAN|19.601||0.8302|TWO_SIDED|95.0|-42.81|34.39|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||34.39|-42.81|0.8302
72559092|NCT01243151|144647861|SUPERIORITY_OR_OTHER||LS Mean Difference|-11.45|STANDARD_ERROR_OF_MEAN|19.581||0.559|TWO_SIDED|95.0|-50.01|27.1|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||27.10|-50.01|0.5590
72559093|NCT01243151|144647861|SUPERIORITY_OR_OTHER||LS Mean Difference|-11.84|STANDARD_ERROR_OF_MEAN|20.069||0.5558|TWO_SIDED|95.0|-51.36|27.69|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||27.69|-51.36|0.5558
72559094|NCT01243151|144647861|SUPERIORITY_OR_OTHER||LS Mean Difference|-8.3|STANDARD_ERROR_OF_MEAN|20.332||0.6835|TWO_SIDED|95.0|-48.34|31.74|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||31.74|-48.34|0.6835
72559095|NCT01243151|144647861|SUPERIORITY_OR_OTHER||LS Mean Difference|-11.15|STANDARD_ERROR_OF_MEAN|19.601||0.5699|TWO_SIDED|95.0|-49.75|27.45|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||27.45|-49.75|0.5699
72440150|NCT00232180|144393536|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.577|||<|0.0001|TWO_SIDED|95.0|0.475|0.701||Statistically significant if p-value \<0.01|Cox proportional hazard model|||The statistical analysis was only performed on the adjudicated endpoint data up to cut-off. Cox proportional hazard model includes treatment as the major factor, adjusting for age, estimated glomerular filtration rate, left ventricular ejection fraction, body mass index, hemoglobin, heart rate, systolic blood pressure, diabetes, history of hypertension, prior myocardial infarction, baseline left bundle branch block, QRS complex and atrial fibrillation as covariates.||0.701|0.475|<0.0001
72440151|NCT00232180|144393537|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.694|||<|0.0001|TWO_SIDED|95.0|0.598|0.806||Statistically significant if p-value \<0.01|Cox proportional hazard model|||The statistical analysis was only performed on the adjudicated endpoint data up to cut-off. Cox proportional hazard model includes treatment as the major factor, adjusting for age, estimated glomerular filtration rate, left ventricular ejection fraction, body mass index, hemoglobin, heart rate, systolic blood pressure, diabetes, history of hypertension, prior myocardial infarction, baseline left bundle branch block, QRS complex and atrial fibrillation as covariates.||0.806|0.598|<0.0001
72440152|NCT00232180|144393538|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.316||||0.2321|TWO_SIDED|95.0|0.839|2.064||Statistically significant if p-value \<0.01|Cox proportional hazard model|||The statistical analysis was only performed on the adjudicated endpoint data up to cut-off. Cox proportional hazard model includes treatment as the major factor, adjusting for age, estimated glomerular filtration rate, left ventricular ejection fraction, body mass index, hemoglobin, heart rate, systolic blood pressure, diabetes, history of hypertension, prior myocardial infarction, baseline left bundle branch block, QRS complex and atrial fibrillation as covariates.||2.064|0.839|0.2321
72440153|NCT00232180|144393539|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.789||||0.4213|TWO_SIDED|95.0|0.443|1.406||Statistically significant if p-value \<0.01|Cox proportional hazard model|||The statistical analysis was only performed on the adjudicated endpoint data up to cut-off. Cox proportional hazard model includes treatment as the major factor, adjusting for age, estimated glomerular filtration rate, left ventricular ejection fraction, body mass index, hemoglobin, heart rate, systolic blood pressure, diabetes, history of hypertension, prior myocardial infarction, baseline left bundle branch block, QRS complex and atrial fibrillation as covariates.||1.406|0.443|0.4213
72440154|NCT00232180|144393540|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.994||||0.9754|TWO_SIDED|95.0|0.694|1.424||Statistically significant if p-value \<0.01|Cox proportional hazard model|||The statistical analysis was only performed on the adjudicated endpoint data up to cut-off. Cox proportional hazard model includes treatment as the major factor, adjusting for age, estimated glomerular filtration rate, left ventricular ejection fraction, body mass index, hemoglobin, heart rate, systolic blood pressure, diabetes, history of hypertension, prior myocardial infarction, baseline left bundle branch block, QRS complex and atrial fibrillation as covariates.||1.424|0.694|0.9754
72440155|NCT00232180|144393541|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.77||||0.2652|TWO_SIDED|95.0|0.485|1.22||Statistically significant if p-value \<0.01|Cox proportional hazard model|||The statistical analysis was only performed on the adjudicated endpoint data up to cut-off. Cox proportional hazard model includes treatment as the major factor, adjusting for age, estimated glomerular filtration rate, left ventricular ejection fraction, body mass index, hemoglobin, heart rate, systolic blood pressure, diabetes, history of hypertension, prior myocardial infarction, baseline left bundle branch block, QRS complex and atrial fibrillation as covariates.||1.220|0.485|0.2652
72440156|NCT00232180|144393542|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.971||||0.9537|TWO_SIDED|95.0|0.366|2.578||Statistically significant if p-value \<0.01|Cox proportional hazard model|||The statistical analysis was only performed on the adjudicated endpoint data up to cut-off. Cox proportional hazard model includes treatment as the major factor, adjusting for age, estimated glomerular filtration rate, left ventricular ejection fraction, body mass index, hemoglobin, heart rate, systolic blood pressure, diabetes, history of hypertension, prior myocardial infarction, baseline left bundle branch block, QRS complex and atrial fibrillation as covariates.||2.578|0.366|0.9537
72559096|NCT01243151|144647861|SUPERIORITY_OR_OTHER||LS Mean Difference|-17.42|STANDARD_ERROR_OF_MEAN|19.918||0.3826|TWO_SIDED|95.0|-56.64|21.8|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||21.80|-56.64|0.3826
72559097|NCT01243151|144647861|SUPERIORITY_OR_OTHER||LS Mean Difference|-12.83|STANDARD_ERROR_OF_MEAN|20.069||0.5233|TWO_SIDED|95.0|-52.35|26.7|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||26.70|-52.35|0.5233
72559098|NCT01243151|144647861|SUPERIORITY_OR_OTHER||LS Mean Difference|-19.47|STANDARD_ERROR_OF_MEAN|20.332||0.3391|TWO_SIDED|95.0|-59.51|20.57|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||20.57|-59.51|0.3391
72559099|NCT01243151|144647861|SUPERIORITY_OR_OTHER||LS Mean Difference|-17.95|STANDARD_ERROR_OF_MEAN|19.601||0.3606|TWO_SIDED|95.0|-56.55|20.65|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||20.65|-56.55|0.3606
72559100|NCT01243151|144647861|SUPERIORITY_OR_OTHER||LS Mean Difference|-12.33|STANDARD_ERROR_OF_MEAN|19.918||0.5364|TWO_SIDED|95.0|-51.55|26.89|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||26.89|-51.55|0.5364
72387499|NCT02609828|144283479|SUPERIORITY||Difference in LS mean|-0.66|STANDARD_ERROR_OF_MEAN|0.25||0.0092|TWO_SIDED|95.0|-1.16|-0.17|||ANCOVA|||Change at Week 2: ANCOVA model for imputed datasets included treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and baseline average pain intensity at the index bone metastasis cancer pain site and baseline opioid dose as covariates.||-0.17|-1.16|0.0092
72387500|NCT02609828|144283479|SUPERIORITY||Difference in LS mean|-0.74|STANDARD_ERROR_OF_MEAN|0.32||0.0218|TWO_SIDED|95.0|-1.37|-0.11|||ANCOVA|||Change at Week 4: ANCOVA model for imputed datasets included treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and baseline average pain intensity at the index bone metastasis cancer pain site and baseline opioid dose as covariates.||-0.11|-1.37|0.0218
72387501|NCT02609828|144283479|SUPERIORITY||Difference in LS mean|-0.87|STANDARD_ERROR_OF_MEAN|0.36||0.0154|TWO_SIDED|95.0|-1.58|-0.17|||ANCOVA|||Change at Week 6: ANCOVA model for imputed datasets included treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and baseline average pain intensity at the index bone metastasis cancer pain site and baseline opioid dose as covariates.||-0.17|-1.58|0.0154
72387502|NCT02609828|144283479|SUPERIORITY||Difference in LS mean|-0.59|STANDARD_ERROR_OF_MEAN|0.39||0.1289|TWO_SIDED|95.0|-1.36|0.17|||ANCOVA|||Change at Week 12: ANCOVA model for imputed datasets included treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and baseline average pain intensity at the index bone metastasis cancer pain site and baseline opioid dose as covariates.||0.17|-1.36|0.1289
72387503|NCT02609828|144283479|SUPERIORITY||Difference in LS mean|-0.55|STANDARD_ERROR_OF_MEAN|0.44||0.211|TWO_SIDED|95.0|-1.43|0.32|||ANCOVA|||Change at Week 16: ANCOVA model for imputed datasets included treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and baseline average pain intensity at the index bone metastasis cancer pain site and baseline opioid dose as covariates.||0.32|-1.43|0.2110
72387504|NCT02609828|144283479|SUPERIORITY||Difference in LS mean|-0.58|STANDARD_ERROR_OF_MEAN|0.46||0.2049|TWO_SIDED|95.0|-1.49|0.32|||ANCOVA|||Change at Week 24: ANCOVA model for imputed datasets included treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and baseline average pain intensity at the index bone metastasis cancer pain site and baseline opioid dose as covariates.||0.32|-1.49|0.2049
72387505|NCT02609828|144283480|SUPERIORITY||Difference in LS mean|-0.33|STANDARD_ERROR_OF_MEAN|0.2||0.1103|TWO_SIDED|95.0|-0.73|0.07|||ANCOVA|||Change at Week 1: ANCOVA model for imputed datasets included treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site and baseline opioid dose as covariates.||0.07|-0.73|0.1103
72387506|NCT02609828|144283480|SUPERIORITY||Difference in LS mean|-0.73|STANDARD_ERROR_OF_MEAN|0.27||0.0084|TWO_SIDED|95.0|-1.26|-0.19|||ANCOVA|||Change at Week 2: ANCOVA model for imputed datasets included treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site and baseline opioid dose as covariates.||-0.19|-1.26|0.0084
72440157|NCT00232180|144393543|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.154||||0.8539|TWO_SIDED|95.0|0.251|5.312||Statistically significant if p-value \<0.01|Cox proportional hazard model|||The statistical analysis was only performed on the adjudicated endpoint data up to cut-off. Cox proportional hazard model includes treatment as the major factor, adjusting for age, estimated glomerular filtration rate, left ventricular ejection fraction, body mass index, hemoglobin, heart rate, systolic blood pressure, diabetes, history of hypertension, prior myocardial infarction, baseline left bundle branch block, QRS complex and atrial fibrillation as covariates.||5.312|0.251|0.8539
72559101|NCT01243151|144647861|SUPERIORITY_OR_OTHER||LS Mean Difference|-11.56|STANDARD_ERROR_OF_MEAN|20.069||0.5651|TWO_SIDED|95.0|-51.08|27.96|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||27.96|-51.08|0.5651
72559102|NCT01243151|144647861|SUPERIORITY_OR_OTHER||LS Mean Difference|-14.65|STANDARD_ERROR_OF_MEAN|20.332||0.4719|TWO_SIDED|95.0|-54.69|25.39|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||25.39|-54.69|0.4719
72559103|NCT01243151|144647861|SUPERIORITY_OR_OTHER||LS Mean Difference|-16.53|STANDARD_ERROR_OF_MEAN|19.601||0.3999|TWO_SIDED|95.0|-55.13|22.07|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||22.07|-55.13|0.3999
72387507|NCT02609828|144283480|SUPERIORITY||Difference in LS mean|-0.75|STANDARD_ERROR_OF_MEAN|0.33||0.0236|TWO_SIDED|95.0|-1.39|-0.1|||ANCOVA|||Change at Week 4:ANCOVA model for imputed datasets included treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site and baseline opioid dose as covariates.||-0.10|-1.39|0.0236
72559104|NCT03123874|144647888|OTHER|Linear mixed effects models testing the effect of pump set-up on the number of live aerobic bacterial counts. The fixed effect of interest will be pump set-up. Model will also be adjusted for infant feeding status (human milk only vs. human milk and complementary foods) and randomization schedule (which pump set-up went first).|Mean Difference (Final Values)|0.827||||0.9|TWO_SIDED|||||Results were considered statistically significant at p\<0.05. No adjustments were made to p-values.|Mixed Models Analysis||Ratio of mean bacterial taxa in milk collected with own / sterile pump set-ups.|||||0.9
72559105|NCT03123874|144647889|OTHER|Linear mixed effects models testing the effect of pump set-up on the number of live aerobic bacterial counts. The fixed effect of interest will be pump set-up. Model will also be adjusted for infant feeding status (human milk only vs. human milk and complementary foods) and randomization schedule (which pump set-up went first).|Mean Difference (Final Values)|0.163||||0.3|TWO_SIDED|||||Results were considered statistically significant at p\<0.05. No adjustments were made to p-values.|Mixed Models Analysis||Ratio of mean Shannon Diversity Index in milk collected with own / sterile pump set-ups|||||0.3
72619003|NCT03615534|144768409|SUPERIORITY|||||||0.033||||||Results were evaluated in terms of adjusted end line ALT levels, embracing the least significant difference (LSD) for pair-wise comparison. Probability of less than 0.05 was considered statistically significant.|ANCOVA|Covariates appearing in ANCOVA model are evaluated at the following baseline values: ALT= 16.0 IU/L.||Analysis of Covariance (ANCOVA), was applied to assess treatment effects among different arms, comprising the influence of the baseline ALT level as a covariate.||||0.033
72440158|NCT00232180|144393544|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.585||||0.0175|TWO_SIDED|95.0|0.376|0.91||Statistically significant if p-value \<0.01|Cox proportional hazard model|||The statistical analysis was only performed on the adjudicated endpoint data up to cut-off. Cox proportional hazard model includes treatment as the major factor, adjusting for age, estimated glomerular filtration rate, left ventricular ejection fraction, body mass index, hemoglobin, heart rate, systolic blood pressure, diabetes, history of hypertension, prior myocardial infarction, baseline left bundle branch block, QRS complex and atrial fibrillation as covariates.||0.910|0.376|0.0175
72440159|NCT00232180|144393545|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.885||||0.6009|TWO_SIDED|95.0|0.559|1.4||Statistically significant if p-value \<0.01|Cox proportional hazard model|||The statistical analysis was only performed on the adjudicated endpoint data up to cut-off. Cox proportional hazard model includes treatment as the major factor, adjusting for age, estimated glomerular filtration rate, left ventricular ejection fraction, body mass index, hemoglobin, heart rate, systolic blood pressure, diabetes, history of hypertension, prior myocardial infarction, baseline left bundle branch block, QRS complex and atrial fibrillation as covariates.||1.400|0.559|0.6009
72440160|NCT02706717|144393555|SUPERIORITY||Mean Difference (Net)|-51.3||||0.6|TWO_SIDED|95.0|-246.0|143.9|||t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Visbiome ES mean minus placebo mean.|||143.9|-246|0.60
72440161|NCT02706717|144393561|SUPERIORITY||Mean Difference (Net)|0.042||||0.51|TWO_SIDED|95.0|-0.09|0.17|||t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Visbiome ES mean minus placebo mean.|||0.17|-0.09|0.51
72440162|NCT02706717|144393562|SUPERIORITY||Mean Difference (Net)|28.4||||0.09|TWO_SIDED|95.0|-3.6|71.0|||t-test, 2 sided|2-sample t-test with equal variance|"The estimation parameter is the percent difference between the geometric mean fold changes.~With d-dimer data log10 transformed, this is (exp(Visbiome ES mean minus placebo mean) - 1)\*100."|||71.0|-3.6|0.09
72440163|NCT02706717|144393565|SUPERIORITY||Mean Difference (Net)|-32.7||||0.29|TWO_SIDED|95.0|-93.5|28.2|||t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Visbiome ES mean minus placebo mean.|||28.2|-93.5|0.29
72440164|NCT02706717|144393566|SUPERIORITY||Mean Difference (Net)|-0.02||||0.41|TWO_SIDED|95.0|-0.08|0.04|||t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Visbiome ES mean minus placebo mean.|||0.04|-0.08|0.41
72440165|NCT02706717|144393583|SUPERIORITY|||||||0.15|||||||Kruskal-Wallis|||||||0.15
72440166|NCT01911169|144393585|OTHER||Cohen's d|0.68|||||TWO_SIDED|||||||||Effect size of primary outcome was calculated||||
72440167|NCT01911169|144393585|SUPERIORITY_OR_OTHER||||||>|0.05|||||||t-test, 2 sided|||This study was conducted to determine the effect size for in change in FMD at 16 weeks with 25(OH) therapy. For change in FMD at 16 weeks with 25(OH)D repletion, based on this effect size, to detect significant differences between 2 groups, assuming 1) normally distributed data, 2) the same effect size, 3) alpha= 0.05, and 4) a power of 0.8, 35 patients in each group would be required. Therefore, this was designed as a pilot to determine effect size.||||> 0.05
72440168|NCT03873337|144393599|SUPERIORITY||||||<|0.001||||||not adjusted for multiple comparisons|t-test, 1 sided|df = 25||One-tailed, paired sample t-tests will be used to examine decreases in scores on the TASQ at one-month post target quit date (2-months after baseline assessment.||||<0.001
72619004|NCT03615534|144768409|SUPERIORITY|||||||0.511||||||Results were evaluated in terms of adjusted end line CK levels, embracing the least significant difference (LSD) for pair-wise comparison. Probability of less than 0.05 was considered statistically significant.|ANCOVA|Covariates appearing in ANCOVA model are evaluated at the following baseline values: CK= 28.0 IU/L.||Analysis of Covariance (ANCOVA), was applied to assess treatment effects among different arms, comprising the influence of the baseline CK level as a covariate.||||0.511
72440169|NCT03873337|144393599|SUPERIORITY|||||||0.002||||||not adjusted for multiple comparisons|t-test, 1 sided|df = 27||One-tailed, paired sample t-tests will be used to examine decreases in scores on the TASQ at 3-months post target quit date (4 months after baseline assessment.||||0.002
72440170|NCT03873337|144393600|SUPERIORITY||||||<|0.001||||||not adjusted for multiple comparisons|t-test, 1 sided|df = 27||One-tailed, paired sample t-tests will be used to examine decreases in cigarettes smoked per day at one-month post target quit date (2-months after baseline assessment.||||<0.001
72440171|NCT03873337|144393600|SUPERIORITY||||||<|0.001||||||not adjusted for multiple comparisons|t-test, 1 sided|df = 27||One-tailed, paired sample t-tests will be used to examine decreases in cigarettes smoked per day at 3-months post target quit date (4-months after baseline assessment.||||<0.001
72440172|NCT02512965|144393601|SUPERIORITY||Odds Ratio (OR)|3.46||||0.0002|TWO_SIDED|95.0|1.79|6.69||2-sided, adjusted for stratification factors at randomization.|Cochran-Mantel-Haenszel||Mantel-Haenszel estimate stratified by stratification factor at randomization.|||6.69|1.79|0.0002
72440173|NCT02512965|144393602|SUPERIORITY||Odds Ratio (OR)|2.56||||0.0036|TWO_SIDED|95.0|1.35|4.85|||Cochran-Mantel-Haenszel||Mantel-Haenszel estimate stratified by stratification factors at randomization.|||4.85|1.35|0.0036
72440174|NCT02512965|144393603|SUPERIORITY||Hazard Ratio (HR)|0.75||||0.26|TWO_SIDED|95.0|0.46|1.24|||Log Rank|2-sided p-value adjusted for stratification factors at randomization.|Estimate adjusted for stratification factors at randopmization.|||1.24|0.46|0.26
72440175|NCT02512965|144393604|SUPERIORITY||Hazard Ratio (HR)|0.82||||0.47|TWO_SIDED|95.0|0.48|1.4||2-sided p-value adjusted for stratification factors at randomization.|Log Rank|||||1.40|0.48|0.47
72440176|NCT01185782|144393628|NON_INFERIORITY_OR_EQUIVALENCE|"The primary endpoint was to determine whether or not SJ-0021 is inferior to u-hFSH in inducing ovulation. The criterion for non-inferiority was that the lower limit of the two-sided 95% CI (= one-sided 97.5% CI) had to be greater than -15% for SJ-0021 to be considered not inferior to u-hFSH.)"|Delta|-3.51|||||TWO_SIDED|95.0|-13.05|6.04|||Chi-squared|||||6.04|-13.05|
72440177|NCT01185782|144393629|SUPERIORITY_OR_OTHER|||||||0.214||95.0|||||Chi-squared|||||||0.214
72440178|NCT01185782|144393630|SUPERIORITY_OR_OTHER|||||||0.087||95.0|||||t-test, 2 sided|||||||0.087
72440179|NCT01185782|144393631|SUPERIORITY_OR_OTHER|||||||0.069||95.0|||||t-test, 2 sided|||||||0.069
72440180|NCT01185782|144393632|SUPERIORITY_OR_OTHER|||||||0.852||95.0|||||Chi-squared|||||||0.852
72440181|NCT01185782|144393633|SUPERIORITY_OR_OTHER|||||||0.102||95.0|||||Chi-squared|||||||0.102
72440182|NCT01185782|144393634|SUPERIORITY_OR_OTHER|||||||0.56||95.0|||||Chi-squared|||||||0.560
72440183|NCT01185782|144393635|SUPERIORITY_OR_OTHER|||||||0.555||95.0|||||Chi-squared|||||||0.555
72440184|NCT01185782|144393636|SUPERIORITY_OR_OTHER|||||||0.416||95.0|||||Chi-squared|||||||0.416
72440185|NCT03740009|144393640|NON_INFERIORITY|For analyses the researchers used a paired T-test to compare baseline and post-treatment mean activation values across 3 regions of interest (ROIs): the caudate, putamen and nucleus accumbens.||||||0.53|||||||t-test, 2 sided|||\[Ho\]: TSEC has no meaningful effect on activity within key nodes of the frontostriate in response to reward.||||0.53
72440186|NCT03740009|144393641|NON_INFERIORITY|Analysis included MASQ-AD scores from all visits to characterize the change in scores from baseline to post-treatment.|GLM|-5.8|STANDARD_ERROR_OF_MEAN|1.59|<|0.001|TWO_SIDED|||||Mixed models of 3 week TSEC administration for MASQ-AD scores assessed at each study visit from baseline to post-treatment.|GLM||F value=13.26|\[Ho\] No change in depressive symptoms from baseline throughout 3 weeks of TSEC administration||||<0.001
72495919|NCT01337973|144521457|SUPERIORITY||coefficient estimate|0.85|||<|0.05|TWO_SIDED|95.0|0.4|1.8||The threshold for significance was p\<0.05. Scores are reported stratified by whether they are less than 0.05, less than 0.01, and less than 0.001.|Wilcoxon Z|Wilcoxon Z value: -2.13|E-TAU arm is the referent group|"Bivariate analyses examined change from baseline to follow up of substance use outcomes measures using Wilcoxon sign rank tests.~This test applies to marijuana use % change from baseline"||1.8|0.4|<0.05
72495920|NCT01337973|144521457|SUPERIORITY||coefficient estimate|0.84|||<|0.05|TWO_SIDED|95.0|0.54|1.32||The threshold for significance was p\<0.05. Scores are reported stratified by whether they are less than 0.05, less than 0.01, and less than 0.001.|Wilcoxon Z|Wilcoxon Z value: -2.48|E-TAU arm is the referent group|"Bivariate analyses examined change from baseline to follow up of substance use outcomes measures using Wilcoxon sign rank tests.~This test applies to illicit drug use % change from baseline"||1.32|0.54|<0.05
72440187|NCT01061151|144393642|SUPERIORITY||Risk Difference (RD)|-1.3|||||TWO_SIDED|96.5|-2.1|-0.4|||||The combination of Arm B and Arm C minus Arm A, based on a repeated confidence interval (Lan-DeMets approach with an O'Brien-Fleming type I error spending function to preserve an experiment-wise type I error rate of 5%).|Arm B and Arm C were combined and compared to Arm A. This comparison was an a priori planned comparison.||-0.4|-2.1|
72440188|NCT01061151|144393643|SUPERIORITY|||||||0.008|||||||Fisher Exact|||Periods 1 and 2||||0.008
72440189|NCT01061151|144393643|SUPERIORITY|||||||0.77|||||||Fisher Exact|||Period 2||||0.77
72440190|NCT01061151|144393643|SUPERIORITY||||||>|0.99|||||||Fisher Exact|||Period 2||||>0.99
72440191|NCT01061151|144393644|SUPERIORITY|||||||0.3|||||||Fisher Exact|||Periods 1 and 2||||0.30
72440192|NCT01061151|144393644|SUPERIORITY|||||||0.64|||||||Fisher Exact|||Period 2||||0.64
72440193|NCT01061151|144393644|SUPERIORITY|||||||0.06|||||||Fisher Exact|||Period 2||||0.06
72440194|NCT01061151|144393645|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||Periods 1 and 2||||<0.001
72440195|NCT01061151|144393645|SUPERIORITY|||||||0.04|||||||Fisher Exact|||Period 2||||0.04
72440196|NCT01061151|144393645|SUPERIORITY|||||||0.46|||||||Fisher Exact|||Period 2||||0.46
72440197|NCT01061151|144393646|SUPERIORITY||Hazard Ratio (HR)|1.0|||||TWO_SIDED|96.0|0.3|3.1|||||The confidence interval was based on a repeated confidence interval.|||3.1|0.3|
72440198|NCT01061151|144393647|SUPERIORITY|||||||0.98|||||||Log Rank|||||||0.98
72440199|NCT01061151|144393648|SUPERIORITY||Hazard Ratio (HR)|0.55||||0.37|TWO_SIDED|95.0|0.14|2.08|||Log Rank||The hazard ratio compares Arm A relative to Arm B.|||2.08|0.14|0.37
72440200|NCT01061151|144393650|SUPERIORITY|||||||0.16|||||||Two-sided Z test|||Overall survival||||0.16
72440201|NCT01061151|144393650|SUPERIORITY|||||||0.0156|||||||Two-sided Z test|||Overall survival, period 2 group||||0.0156
72440202|NCT01061151|144393650|SUPERIORITY|||||||0.31|||||||Two-sided Z test|||Overall survival, period 2 group||||0.31
72440203|NCT01061151|144393650|SUPERIORITY|||||||0.0022|||||||Two-sided Z test|||Overall survival, period 2 group||||0.0022
72440204|NCT01061151|144393650|SUPERIORITY|||||||0.13|||||||Two-sided Z test|||HIV-free survival||||0.13
72440205|NCT01061151|144393650|SUPERIORITY|||||||0.44|||||||Two-sided Z test|||HIV-free survival, period 2 group||||0.44
72440206|NCT01061151|144393650|SUPERIORITY|||||||0.24|||||||Two-sided Z test|||HIV-free survival, period 2 group||||0.24
72440207|NCT01061151|144393650|SUPERIORITY|||||||0.26|||||||Two-sided Z test|||HIV-free survival, group 2||||0.26
72387508|NCT02609828|144283480|SUPERIORITY||Difference in LS mean|-0.88|STANDARD_ERROR_OF_MEAN|0.36||0.0155|TWO_SIDED|95.0|-1.59|-0.17|||ANCOVA|||Change at Week 6: ANCOVA model for imputed datasets included treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site and baseline opioid dose as covariates.||-0.17|-1.59|0.0155
72387509|NCT02609828|144283480|SUPERIORITY||Difference in LS mean|-0.76|STANDARD_ERROR_OF_MEAN|0.38||0.0505|TWO_SIDED|95.0|-1.52|0.0|||ANCOVA|||Change at Week 8: ANCOVA model for imputed datasets included treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site and baseline opioid dose as covariates.||0.00|-1.52|0.0505
72387510|NCT02609828|144283480|SUPERIORITY||Difference in LS mean|-0.72|STANDARD_ERROR_OF_MEAN|0.4||0.0761|TWO_SIDED|95.0|-1.52|0.08|||ANCOVA|||Change at Week 12: ANCOVA model for imputed datasets included treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site and baseline opioid dose as covariates.||0.08|-1.52|0.0761
72387511|NCT02609828|144283480|SUPERIORITY||Difference in LS mean|-0.74|STANDARD_ERROR_OF_MEAN|0.48||0.1263|TWO_SIDED|95.0|-1.7|0.21|||ANCOVA|||Change at Week 16: ANCOVA model for imputed datasets included treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site and baseline opioid dose as covariates.||0.21|-1.70|0.1263
72387512|NCT02609828|144283480|SUPERIORITY||Difference in LS mean|-0.79|STANDARD_ERROR_OF_MEAN|0.49||0.1051|TWO_SIDED|95.0|-1.76|0.17|||ANCOVA|||Change at Week 24: ANCOVA model for imputed datasets included treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site and baseline opioid dose as covariates.||0.17|-1.76|0.1051
72387513|NCT02609828|144283481|SUPERIORITY||Difference in LS mean|-0.5|STANDARD_ERROR_OF_MEAN|0.48||0.3003|TWO_SIDED|95.0|-1.47|0.47|||ANCOVA|||Change at Week 1: ANCOVA model for imputed datasets included treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and baseline average pain intensity at the index bone metastasis cancer pain site and baseline opioid dose as covariates.||0.47|-1.47|0.3003
72387514|NCT02609828|144283481|SUPERIORITY||Difference in LS mean|-0.84|STANDARD_ERROR_OF_MEAN|0.59||0.1603|TWO_SIDED|95.0|-2.03|0.35|||ANCOVA|||Change at Week 2: ANCOVA model for imputed datasets included treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and baseline average pain intensity at the index bone metastasis cancer pain site and baseline opioid dose as covariates.||0.35|-2.03|0.1603
72440208|NCT03292913|144393708|SUPERIORITY||Risk Ratio (RR)|1.07||||0.22|TWO_SIDED|95.0|0.96|1.21|||Mixed Models Analysis|Risk ratio is adjusted for sex, age, race, site, viral load suppression at baseline, and new to care.||Outcome measure for this analysis is viral load suppression. A priori threshold for statistical significance is p-value less than 0.05.||1.21|0.96|0.220
72440209|NCT03292913|144393709|SUPERIORITY||Risk Ratio (RR)|1.04||||0.481|TWO_SIDED|95.0|0.94|1.15|||Mixed Models Analysis|Risk ratio is adjusted for sex, age, race, site, and new to care.||Outcome measure for this analysis is retention in care. A priori threshold for statistical significance is p-value less than 0.05.||1.15|0.94|0.481
72504752|NCT03114969|144540502|SUPERIORITY||Odds Ratio (OR)|5.484|||<|0.001|TWO_SIDED|95.0|2.106|14.284||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator.|||14.284|2.106|<0.001
72387515|NCT02609828|144283481|SUPERIORITY||Difference in LS mean|-0.8|STANDARD_ERROR_OF_MEAN|0.66||0.2298|TWO_SIDED|95.0|-2.13|0.53|||ANCOVA|||Change at Week 4: ANCOVA model for imputed datasets included treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and baseline average pain intensity at the index bone metastasis cancer pain site and baseline opioid dose as covariates.||0.53|-2.13|0.2298
72387516|NCT02609828|144283481|SUPERIORITY||Difference in LS mean|-0.48|STANDARD_ERROR_OF_MEAN|0.72||0.5054|TWO_SIDED|95.0|-1.93|0.97|||ANCOVA|||Change at Week 6: ANCOVA model for imputed datasets included treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and baseline average pain intensity at the index bone metastasis cancer pain site and baseline opioid dose as covariates.||0.97|-1.93|0.5054
72387517|NCT02609828|144283481|SUPERIORITY||Difference in LS mean|-0.55|STANDARD_ERROR_OF_MEAN|-0.77||0.4793|TWO_SIDED|95.0|-2.1|1.01|||ANCOVA|||Change at Week 8: ANCOVA model for imputed datasets included treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and baseline average pain intensity at the index bone metastasis cancer pain site and baseline opioid dose as covariates.||1.01|-2.10|0.4793
72440210|NCT03292913|144393710|SUPERIORITY||Risk Ratio (RR)|0.86||||0.093|TWO_SIDED|95.0|0.72|1.03|||Mixed Models Analysis|Risk ratio is adjusted for sex, age, race, site, and new to care.||Outcome measure for this analysis is a 6-month visit gap defined ashaving at least 189 days between two sequentially kept visits, post-randomization. A priori threshold for statistical significance is p-value less than 0.05.||1.03|0.72|0.093
72440211|NCT03950622|144393711|OTHER|Estimated differences, confidence intervals (CIs), and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percent|-2.4||||0.175|TWO_SIDED|95.0|-5.8|1.1|||Miettinen & Nurminen|||Injection site redness/erythema||1.1|-5.8|0.175
72440212|NCT03950622|144393711|OTHER|Estimated differences, CIs, and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percent|11.7|||<|0.001|TWO_SIDED|95.0|6.0|17.2|||Miettinen & Nurminen|||Injection site tenderness/pain||17.2|6.0|<0.001
72559106|NCT03123874|144647890|OTHER|Linear mixed effects models testing the effect of pump set-up on the number of live aerobic bacterial counts. The fixed effect of interest will be pump set-up. Model will also be adjusted for infant feeding status (human milk only vs. human milk and complementary foods) and randomization schedule (which pump set-up went first). Random effect was participant ID to account for multiple samples for each participant.|Mean Difference (Final Values)|4.95||||0.0003|TWO_SIDED|||||Results were considered statistically significant at p\<0.05. No adjustments were made to p-values.|Mixed Models Analysis||Ratio of mean bacterial counts in milk collected with own / sterile pump set-ups.|||||0.0003
72559107|NCT01630616|144647908|SUPERIORITY_OR_OTHER||Ratio (Adolescents/adults)|0.89|||||TWO_SIDED|90.0|0.62|1.26||||||||1.26|0.62|
72559108|NCT01630616|144647909|SUPERIORITY_OR_OTHER||Ratio (Adolescents/Adults)|0.87|||||TWO_SIDED|90.0|0.62|1.23||||||||1.23|0.62|
72559109|NCT01630616|144647910|SUPERIORITY_OR_OTHER||Ratio (Adolescents/Adults)|0.81|||||TWO_SIDED|90.0|0.57|1.16||||||||1.16|0.57|
72559110|NCT01993186|144647918|SUPERIORITY||Hodges-Lehmann estimate|13.45||||0.5812|TWO_SIDED|90.0|-38.63|80.95|||Wilcoxon rank-sum test|||Non-parametric post-hoc analysis: Hodges-Lehmann estimate of the location shift with 90% confidence interval (CI) and Wilcoxon Rank Sum test p-value, based on Wilcoxon rank-sum test||80.95|-38.63|0.5812
72559111|NCT01993186|144647921|SUPERIORITY||Hodges-Lehmann estimate|0.0||||0.8197|TWO_SIDED|90.0|-51.23|84.25|||Wilcoxon rank-sum test|||Non-parametric post-hoc analysis: Hodges-Lehmann estimate of the location shift with 90% CI and Wilcoxon Rank Sum test p-value, based on Wilcoxon rank-sum test||84.25|-51.23|0.8197
72559112|NCT01993186|144647922|SUPERIORITY||Hodges-Lehmann estimate|0.0||||0.7276|TWO_SIDED|90.0|0.0|37.5|||Wilcoxon rank-sum test|||Non-parametric post-hoc analysis: Hodges-Lehmann estimate of the location shift with 90% CI and Wilcoxon Rank Sum test p-value, based on Wilcoxon rank-sum test||37.5|0|0.7276
72440213|NCT03950622|144393711|OTHER|Estimated differences, CIs, and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percent|1.3||||0.488|TWO_SIDED|95.0|-2.4|5.0|||Miettinen & Nurminen|||Injection site swelling||5.0|-2.4|0.488
72559113|NCT01993186|144647926|SUPERIORITY||Least squares mean difference|-2.384|STANDARD_ERROR_OF_MEAN|68.1231||0.486|TWO_SIDED|90.0|-114.44|109.67||One-sided p-value. Additional model covariates include the corresponding baseline CANTAB score, visit and the interaction between visit and treatment.|GEE model|||RTISRTSD||109.67|-114.44|0.486
72559114|NCT01993186|144647926|SUPERIORITY||Least squares mean difference|63.669|STANDARD_ERROR_OF_MEAN|53.0537||0.8849|TWO_SIDED|90.0|-23.6|150.94||One-sided p-value. Additional model covariates include the corresponding baseline CANTAB score, visit and the interaction between visit and treatment.|GEE model|||RTIMDSRT||150.94|-23.6|0.8849
72559115|NCT01993186|144647926|SUPERIORITY||Least squares mean difference|-63.835|STANDARD_ERROR_OF_MEAN|60.6496||0.1463|TWO_SIDED|90.0|-163.59|35.93||One-sided p-value. Additional model covariates include the corresponding baseline CANTAB score, visit and the interaction between visit and treatment.|GEE model|||RTIMDFRT||35.93|-163.59|0.1463
72559116|NCT01993186|144647927|SUPERIORITY||Least squares mean difference|17.768|STANDARD_ERROR_OF_MEAN|11.5659||0.9378|TWO_SIDED|90.0|-1.26|36.79||One-sided p-value. Additional model covariates include the corresponding baseline CANTAB score, visit and the interaction between visit and treatment.|GEE model|||PALTEA||36.79|-1.26|0.9378
72559117|NCT01993186|144647927|SUPERIORITY||Least squares mean difference|-0.531|STANDARD_ERROR_OF_MEAN|2.1853||0.5959|TWO_SIDED|90.0|-4.13|3.06||One-sided p-value. Additional model covariates include the corresponding baseline CANTAB score, visit and the interaction between visit and treatment.|GEE model|||PALFTMS||3.06|-4.13|0.5959
72559118|NCT01993186|144647928|SUPERIORITY||Least squares mean difference|0.06|STANDARD_ERROR_OF_MEAN|0.4988||0.4522|TWO_SIDED|90.0|-0.76|0.88||One-sided p-value. Additional model covariates include the corresponding baseline CANTAB score, visit and the interaction between visit and treatment.|GEE model|||SSPSLF||0.88|-0.76|0.4522
72559119|NCT01993186|144647929|SUPERIORITY||LS Mean Difference|-1.237|STANDARD_ERROR_OF_MEAN|2.381||0.3017|TWO_SIDED|90.0|-5.15|2.68||One-sided p-value. Additional model covariates include the corresponding baseline CANTAB score, visit and the interaction between visit and treatment.|GEE model|||SWMBE48||2.68|-5.15|0.3017
72559120|NCT01993186|144647929|SUPERIORITY||Least squares mean difference|0.038|STANDARD_ERROR_OF_MEAN|0.6495||0.5235|TWO_SIDED|90.0|-1.03|1.11||One-sided p-value. Additional model covariates include the corresponding baseline CANTAB score, visit and the interaction between visit and treatment.|GEE model|||SWMS68||1.11|-1.03|0.5235
72559121|NCT01993186|144647930|SUPERIORITY||Least squares mean difference|-6.897|STANDARD_ERROR_OF_MEAN|22.4806||0.6205|TWO_SIDED|90.0|-43.874|30.08||One-sided p-value. Additional model covariates include the corresponding baseline value, visit and the interaction between visit and treatment.|GEE model|||6MWT distance traveled||30.08|-43.874|0.6205
72440214|NCT03950622|144393712|OTHER|Estimated differences, CIs, and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percent|-0.2||||0.888|TWO_SIDED|95.0|-2.8|2.4|||Miettinen & Nurminen|||Joint pain/arthralgia||2.4|-2.8|0.888
72440215|NCT03950622|144393712|OTHER|Estimated differences, CIs, and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percent|0.1||||0.96|TWO_SIDED|95.0|-4.2|4.4|||Miettinen & Nurminen|||Tiredness/fatigue||4.4|-4.2|0.960
72440216|NCT03950622|144393712|OTHER|Estimated differences, CIs, and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percent|-1.4||||0.469|TWO_SIDED|95.0|-5.1|2.4|||Miettinen & Nurminen|||Headache||2.4|-5.1|0.469
72440217|NCT03950622|144393712|OTHER|Estimated differences, CIs, and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percent|3.4||||0.082|TWO_SIDED|95.0|-0.4|7.4|||Miettinen & Nurminen|||Muscle pain/myalgia||7.4|-0.4|0.082
72440218|NCT03950622|144393713|OTHER|Estimated differences and CIs are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percent|0.0|||||TWO_SIDED|95.0|-0.6|0.6|||Miettinen & Nurminen|||Vaccine-related SAEs||0.6|-0.6|
72495921|NCT01337973|144521457|SUPERIORITY||coefficient estimate|1.15|||<|0.001|TWO_SIDED|95.0|0.78|1.71||The threshold for significance was p\<0.05. Scores are reported stratified by whether they are less than 0.05, less than 0.01, and less than 0.001.|Wilcoxon Z|Wilcoxon Z value: -4.94|E-TAU arm is the referent group|"Bivariate analyses examined change from baseline to follow up of substance use outcomes measures using Wilcoxon sign rank tests.~This test applies to heavy drinking % change from baseline"||1.71|0.78|<0.001
72495922|NCT01337973|144521457|SUPERIORITY||coefficient estimate|0.61|||<|0.05|TWO_SIDED|95.0|0.17|2.16||The threshold for significance was p\<0.05. Scores are reported stratified by whether they are less than 0.05, less than 0.01, and less than 0.001.|Wilcoxon Z|Wilcoxon Z value: -2.56|E-TAU arm is the referent group|"Bivariate analyses examined change from baseline to follow up of substance use outcomes measures using Wilcoxon sign rank tests.~This test applies to cocaine use % change from baseline"||2.16|0.17|<0.05
72495923|NCT01337973|144521457|SUPERIORITY||coefficient estimate|1.18|||<|0.01|TWO_SIDED|95.0|0.57|2.44||The threshold for significance was p\<0.05. Scores are reported stratified by whether they are less than 0.05, less than 0.01, and less than 0.001.|Wilcoxon Z|Wilcoxon Z value: -2.86|E-TAU arm is the referent group|"Bivariate analyses examined change from baseline to follow up of substance use outcomes measures using Wilcoxon sign rank tests.~This test applies to marijuana use % change from baseline"||2.44|0.57|<0.01
72495924|NCT01337973|144521457|SUPERIORITY||coefficient estimate|0.95|||<|0.001|TWO_SIDED|95.0|0.61|1.48||The threshold for significance was p\<0.05. Scores are reported stratified by whether they are less than 0.05, less than 0.01, and less than 0.001.|Wilcoxon Z|Wilcoxon Z value: -3.51|E-TAU arm is the referent group|"Bivariate analyses examined change from baseline to follow up of substance use outcomes measures using Wilcoxon sign rank tests.~This test applies to illicit drug use % change from baseline"||1.48|0.61|<0.001
72495925|NCT01337973|144521457|SUPERIORITY||||||<|0.001||||||The threshold for significance was p\<0.05. Scores are reported stratified by whether they are less than 0.05, less than 0.01, and less than 0.001.|Wilcoxon Z|Wilcoxon Z value: -4.65||"Bivariate analyses examined change from baseline to follow up of substance use outcomes measures using Wilcoxon sign rank tests.~This test applies to heavy drinking % change from baseline"||||<0.001
72495926|NCT01337973|144521457|SUPERIORITY||||||>|0.05||||||The threshold for significance was p\<0.05. Scores are reported stratified by whether they are less than 0.05, less than 0.01, and less than 0.001.|Wilcoxon Z|Wilcoxon Z value: -1.45||"Bivariate analyses examined change from baseline to follow up of substance use outcomes measures using Wilcoxon sign rank tests.~This test applies to cocaine use % change from baseline"||||>0.05
72495927|NCT01337973|144521457|SUPERIORITY||||||>|0.05||||||The threshold for significance was p\<0.05. Scores are reported stratified by whether they are less than 0.05, less than 0.01, and less than 0.001.|Wilcoxon Z|Wilcoxon Z value: -1.5||"Bivariate analyses examined change from baseline to follow up of substance use outcomes measures using Wilcoxon sign rank tests.~This test applies to marijuana use % change from baseline"||||>0.05
72495928|NCT01337973|144521457|SUPERIORITY||||||<|0.05||||||The threshold for significance was p\<0.05. Scores are reported stratified by whether they are less than 0.05, less than 0.01, and less than 0.001.|Wilcoxon Z|Wilcoxon Z value: -2.58||"Bivariate analyses examined change from baseline to follow up of substance use outcomes measures using Wilcoxon sign rank tests.~This test applies to illicit drug use % change from baseline"||||<0.05
72495929|NCT00254566|144521464|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be declared if the lower bound of the 95% CI around the difference in clinical success rates is greater than -10%|Risk Difference (RD)|-0.9||||||95.0|-5.8|3.9|||||Risk difference is the difference in percentage of participants with cure and the 95% Confidence Interval|95% Confidence Interval (CI) for the difference in cure rates will be constructed using a method of linear stratification that weights according to the reciporcal of the variance. Stratification will be by steriod use at time of randomization.||3.9|-5.8|
72495930|NCT00254566|144521465|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be declared if the lower bound of the 95% CI around the difference in clinical success rates is greater than -10%|Risk Difference (RD)|-2.5||||||95.0|-8.5|3.4|||||Risk difference is the difference in the percentage of participants with Cure and the 95% CI|95% CI for the difference in cure rates will be constructed using a method of linear stratification that weights according to the reciporcal of the variance. Stratification will be by steriod use at time of randomization.||3.4|-8.5|
72495931|NCT00254566|144521466|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be declared if the lower bound of the 95% CI around the difference in clinical success rates is greater than -10%|Risk Difference (RD)|-2.5||||||95.0|-8.5|3.4|||||Risk difference is the difference in percentage of participants with cure and the 95% Confidence|95% CI for the difference in cure rates will be constructed using a method of linear stratification that weights according to the reciprocal of the variance. Stratification will be by steroid use at time of randomization.||3.4|-8.5|
72495932|NCT00254566|144521467|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.6||||||95.0|-4.5|3.3|||||Risk difference is the difference in eradication rates of pathogens by treatment|||3.3|-4.5|
72440219|NCT03950622|144393714|NON_INFERIORITY|The statistical criterion for noninferiority requires the lower bound of the 2-sided 95% confidence interval (CI) of the OPA GMT ratio (V114/ Prevnar 13™) to be greater than 0.5.|GMT Ratio|0.79|||<|0.001|TWO_SIDED|95.0|0.66|0.96|||Constrained longitudinal data analysis|GMT ratio, 95% CI, and p-value are estimated from a constrained longitudinal data analysis (cLDA) model.||Serotype 1 (Shared)||0.96|0.66|<0.001
72440220|NCT03950622|144393714|NON_INFERIORITY|The statistical criterion for noninferiority requires the lower bound of the 2-sided 95% confidence interval (CI) of the OPA GMT ratio (V114/ Prevnar 13™) to be greater than 0.5.|GMT Ratio|1.6|||<|0.001|TWO_SIDED|95.0|1.38|1.85|||cLDA|GMT ratio, 95% CI, and p-value are estimated from a cLDA model.||Serotype 3 (Shared)||1.85|1.38|<0.001
72495933|NCT00254566|144521468|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.33||||0.159||95.0|0.9|2.0||p-value was estimated from Cox's Proportional Hazard model with steriod use and country as factors and baseline FEV1 fitted as covariate|Regression, Cox|||Kaplan-Meier method was used to estimate time taken for 1st 25th quartile of subjects to experience recurrence of AECB. Estimate of median time to event couldn't be calculated because \<50% of subjects in analysis population experienced a recurrence. The ratio of the treatment groups' recurrence rate (hazard ratio) estimated using Cox proportional hazards model adjusting for steroid use, frequency of AECB in previous 12 months, country and baseline Forced expiratory volume in 1 second (FEV1).||2.0|0.9|0.159
72495934|NCT00254566|144521469|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.05||||0.57||95.0|-0.21|0.12|||ANCOVA|Estimated from ANCOVA with treatment, steriod use, and country fitted as factor and baseline CCQ total scores and FEV1 fitted as covariates||||0.12|-0.21|0.57
72495935|NCT00254566|144521469|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01||||0.82||95.0|-0.13|0.1|||Mixed Models Analysis|Estimated from linear mixed model with treatment, steroid use, FEV1, country and time point as factors and baseline CCQ scores as a covariate||||0.10|-0.13|0.82
72495936|NCT00254566|144521470|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02||||0.81||95.0|-0.21|0.17|||ANCOVA|Estimated from ANCOVA with treatment, steriod use and country fitted as factors and baseline CCQ total score and FEV1 fitted as covariates||||0.17|-0.21|0.81
72495937|NCT00254566|144521470|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01||||0.87||95.0|-0.12|0.14|||Mixed Models Analysis|Estimated from linear mixed model with treatment, steroid use, FEV1, country and time point as factors and baseline CCQ scores as a covariate||||0.14|-0.12|0.87
72495938|NCT00254566|144521471|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.08||||0.385||95.0|-0.27|0.1|||ANCOVA|Estimated from ANCOVA with treatment, steriod use and country fitted as factors and baseline CCQ total score and FEV1 fitted as covariates||||0.10|-0.27|0.385
72559122|NCT01993186|144647931|SUPERIORITY||Least squares mean difference|-1.354|STANDARD_ERROR_OF_MEAN|3.5759||0.6476|TWO_SIDED|90.0|-7.236|4.527||One-sided p-value. Additional model covariates include the corresponding baseline value, visit and the interaction between visit and treatment.|GEE model|||6MWT distance traveled (percent predicted)||4.527|-7.236|0.6476
72559123|NCT01993186|144647933|SUPERIORITY||Least squares mean difference|1.568|STANDARD_ERROR_OF_MEAN|3.8899||0.3435|TWO_SIDED|90.0|-4.83|7.97||One-sided p-value. Additional model covariates include baseline GMFM-88 total score, visit and the interaction between visit and treatment.|GEE model|||GMFM-88 UX007-Placebo||7.97|-4.83|0.3435
72559124|NCT04158687|144647963|SUPERIORITY||Least Square (LS) Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|1.8||0.6003|TWO_SIDED|95.0|-4.5|2.6|||Mixed model repeated measures (MMRM)|MMRM included fixed effects of treatment group, analysis visit, treatment-by-visit interaction, and a baseline-by-visit interaction.||||2.6|-4.5|0.6003
72495939|NCT00254566|144521471|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.04||||0.56||95.0|-0.17|0.09|||Mixed Models Analysis|Estimated from linear mixed model with treatment, steroid use, FEV1, country and time point as factors and baseline CCQ scores as a covariate||||0.09|-0.17|0.56
72495940|NCT00254566|144521472|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.05||||0.62||95.0|-0.26|0.16|||ANCOVA|Estimated from ANCOVA with treatment, steriod use and country fitted as factors and baseline CCQ total score and FEV1 fitted as covariates||||0.16|-0.26|0.62
72495941|NCT00254566|144521472|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02||||0.8||95.0|-0.18|0.14|||Mixed Models Analysis|Estimated from linear mixed model with treatment, steroid use, FEV1, country and time point as factors and baseline CCQ scores as a covariate||||0.14|-0.18|0.80
72495942|NCT00356031|144521497|OTHER||||||<|0.05|||||||t-test, 1 sided|||||||<.05
72495943|NCT00356031|144521498|OTHER||||||<|0.05|||||||t-test, 1 sided|||||||<.05
72495944|NCT02167945|144521515|SUPERIORITY||||||<|0.001|||||||Log-rank test|||Comparisons between participants in studies M14-222 and M14-423 who achieved SVR12 and those who did not were performed using a log-rank test.||||<0.001
72559125|NCT04158687|144647963|SUPERIORITY||LS Mean Difference|1.5|STANDARD_ERROR_OF_MEAN|1.8||0.392|TWO_SIDED|95.0|-2.0|5.0|||MMRM|MMRM included fixed effects of treatment group, analysis visit, treatment-by-visit interaction, and a baseline-by-visit interaction.||||5.0|-2.0|0.3920
72559126|NCT04158687|144647963|SUPERIORITY||LS Mean Difference|2.6|STANDARD_ERROR_OF_MEAN|1.8||0.1444|TWO_SIDED|95.0|-0.9|6.0|||MMRM|MMRM included fixed effects of treatment group, analysis visit, treatment-by-visit interaction, and a baseline-by-visit interaction.||||6.0|-0.9|0.1444
72559127|NCT04158687|144647964|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.1||0.8065|TWO_SIDED|95.0|-0.3|0.2|||MMRM|MMRM included fixed effects of treatment group, analysis visit, treatment-by-visit interaction, and a baseline-by-visit interaction.||||0.2|-0.3|0.8065
72559128|NCT04158687|144647964|SUPERIORITY||LS Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|0.1||0.2121|TWO_SIDED|95.0|-0.1|0.4|||MMRM|MMRM included fixed effects of treatment group, analysis visit, treatment-by-visit interaction, and a baseline-by-visit interaction.||||0.4|-0.1|0.2121
72559129|NCT04158687|144647964|SUPERIORITY||LS Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|0.1||0.0264|TWO_SIDED|95.0|0.0|0.5|||MMRM|MMRM included fixed effects of treatment group, analysis visit, treatment-by-visit interaction, and a baseline-by-visit interaction.||||0.5|0.0|0.0264
72559130|NCT04158687|144647965|SUPERIORITY||LS Mean Difference|0.7|STANDARD_ERROR_OF_MEAN|1.4||0.6101|TWO_SIDED|95.0|-2.1|3.5|||MMRM|MMRM included fixed effects of treatment group, analysis visit, treatment-by-visit interaction, and a baseline-by-visit interaction.||||3.5|-2.1|0.6101
72559131|NCT04158687|144647965|SUPERIORITY||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|1.4||0.6237|TWO_SIDED|95.0|-3.4|2.1|||MMRM|MMRM included fixed effects of treatment group, analysis visit, treatment-by-visit interaction, and a baseline-by-visit interaction.||||2.1|-3.4|0.6237
72559132|NCT04158687|144647965|SUPERIORITY||LS Mean Difference|-1.9|STANDARD_ERROR_OF_MEAN|1.4||0.1764|TWO_SIDED|95.0|-4.6|0.8|||MMRM|MMRM included fixed effects of treatment group, analysis visit, treatment-by-visit interaction, and a baseline-by-visit interaction.||||0.8|-4.6|0.1764
72559133|NCT01167829|144648006|SUPERIORITY_OR_OTHER||Mean Difference (Net)|183.0|STANDARD_ERROR_OF_MEAN|44.0||0.05|TWO_SIDED|95.0|||||t-test, 2 sided|||||||0.05
72440221|NCT03950622|144393714|NON_INFERIORITY|The statistical criterion for noninferiority requires the lower bound of the 2-sided 95% CI of the OPA GMT ratio (V114/ Prevnar 13™) to be greater than 0.5.|GMT Ratio|0.68|||<|0.001|TWO_SIDED|95.0|0.57|0.8|||cLDA|GMT ratio, 95% CI, and p-value are estimated from a cLDA model.||Serotype 4 (Shared)||0.80|0.57|<0.001
72440222|NCT03950622|144393714|NON_INFERIORITY|The statistical criterion for noninferiority requires the lower bound of the 2-sided 95% confidence interval (CI) of the OPA GMT ratio (V114/ Prevnar 13™) to be greater than 0.5.|GMT Ratio|0.79|||<|0.001|TWO_SIDED|95.0|0.64|0.98|||cLDA|GMT ratio, 95% CI, and p-value are estimated from a cLDA model.||Serotype 5 (Shared)||0.98|0.64|<0.001
72440223|NCT03950622|144393714|NON_INFERIORITY|The statistical criterion for noninferiority requires the lower bound of the 2-sided 95% confidence interval (CI) of the OPA GMT ratio (V114/ Prevnar 13™) to be greater than 0.5.|GMT Ratio|1.0|||<|0.001|TWO_SIDED|95.0|0.84|1.19|||cLDA|GMT ratio, 95% CI, and p-value are estimated from a cLDA model.||Serotype 6A (Shared)||1.19|0.84|<0.001
72440224|NCT03950622|144393714|NON_INFERIORITY|The statistical criterion for noninferiority requires the lower bound of the 2-sided 95% confidence interval (CI) of the OPA GMT ratio (V114/ Prevnar 13™) to be greater than 0.5.|GMT Ratio|1.23|||<|0.001|TWO_SIDED|95.0|1.02|1.48|||cLDA|GMT ratio, 95% CI, and p-value are estimated from a cLDA model.||Serotype 6B (Shared)||1.48|1.02|<0.001
72440225|NCT03950622|144393714|NON_INFERIORITY|The statistical criterion for noninferiority requires the lower bound of the 2-sided 95% confidence interval (CI) of the OPA GMT ratio (V114/ Prevnar 13™) to be greater than 0.5.|GMT Ratio|0.79|||<|0.001|TWO_SIDED|95.0|0.68|0.9|||cLDA|GMT ratio, 95% CI, and p-value are estimated from a cLDA model.||Serotype 7F (Shared)||0.90|0.68|<0.001
72440226|NCT03950622|144393714|NON_INFERIORITY|The statistical criterion for noninferiority requires the lower bound of the 2-sided 95% confidence interval (CI) of the OPA GMT ratio (V114/ Prevnar 13™) to be greater than 0.5.|GMT Ratio|0.81|||<|0.001|TWO_SIDED|95.0|0.7|0.94|||cLDA|GMT ratio, 95% CI, and p-value are estimated from a cLDA model.||Serotype 9V (Shared)||0.94|0.70|<0.001
72440227|NCT03950622|144393714|NON_INFERIORITY|The statistical criterion for noninferiority requires the lower bound of the 2-sided 95% confidence interval (CI) of the OPA GMT ratio (V114/ Prevnar 13™) to be greater than 0.5.|GMT Ratio|0.75|||<|0.001|TWO_SIDED|95.0|0.64|0.89|||cLDA|GMT ratio, 95% CI, and p-value are estimated from a cLDA model.||Serotype 14 (Shared)||0.89|0.64|<0.001
72440228|NCT03950622|144393714|NON_INFERIORITY|The statistical criterion for noninferiority requires the lower bound of the 2-sided 95% confidence interval (CI) of the OPA GMT ratio (V114/ Prevnar 13™) to be greater than 0.5.|GMT Ratio|1.07|||<|0.001|TWO_SIDED|95.0|0.91|1.26|||cLDA|GMT ratio, 95% CI, and p-value are estimated from a cLDA model.||Serotype 18C (Shared)||1.26|0.91|<0.001
72559134|NCT01634139|144648070|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.17|STANDARD_ERROR_OF_MEAN|0.031|<|0.0001|TWO_SIDED|95.0|0.108|0.231|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Stepwise testing of the null hypothesis was used to test the efficacy of Tio R5 and then Tio R2.5, each over placebo. The analysis was performed in a stepwise manner, firstly for this endpoint, then Trough FEV1. Each step was only considered confirmatory if all previous steps were successful.||0.231|0.108|<0.0001
72559135|NCT01634139|144648070|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.164|STANDARD_ERROR_OF_MEAN|0.031|<|0.0001|TWO_SIDED|95.0|0.103|0.255|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Stepwise testing of the null hypothesis was used to test the efficacy of Tio R5 and then Tio R2.5, each over placebo. The analysis was performed in a stepwise manner, firstly for this endpoint, then Trough FEV1. Each step was only considered confirmatory if all previous steps were successful.||0.255|0.103|<0.0001
72559136|NCT01634139|144648071|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.116|STANDARD_ERROR_OF_MEAN|0.036||0.0012|TWO_SIDED|95.0|0.046|0.186|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 24||0.186|0.046|0.0012
72559137|NCT01634139|144648071|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.118|STANDARD_ERROR_OF_MEAN|0.036||0.001|TWO_SIDED|95.0|0.048|0.188|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 24||0.188|0.048|0.0010
72440229|NCT03950622|144393714|NON_INFERIORITY|The statistical criterion for noninferiority requires the lower bound of the 2-sided 95% confidence interval (CI) of the OPA GMT ratio (V114/ Prevnar 13™) to be greater than 0.5.|GMT Ratio|0.8|||<|0.001|TWO_SIDED|95.0|0.7|0.93|||cLDA|GMT ratio, 95% CI, and p-value are estimated from a cLDA model.||Serotype 19A (Shared)||0.93|0.70|<0.001
72440230|NCT03950622|144393714|NON_INFERIORITY|The statistical criterion for noninferiority requires the lower bound of the 2-sided 95% confidence interval (CI) of the OPA GMT ratio (V114/ Prevnar 13™) to be greater than 0.5.|GMT Ratio|0.88|||<|0.001|TWO_SIDED|95.0|0.76|1.02|||cLDA|GMT ratio, 95% CI, and p-value are estimated from a cLDA model.||Serotype 19F (Shared)||1.02|0.76|<0.001
72559138|NCT01634139|144648071|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.071|STANDARD_ERROR_OF_MEAN|0.036||0.0477|TWO_SIDED|95.0|0.001|0.142|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 48||0.142|0.001|0.0477
72559139|NCT01634139|144648071|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.099|STANDARD_ERROR_OF_MEAN|0.036||0.0059|TWO_SIDED|95.0|0.029|0.17|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 48||0.170|0.029|0.0059
72440231|NCT03950622|144393714|NON_INFERIORITY|The statistical criterion for noninferiority requires the lower bound of the 2-sided 95% confidence interval (CI) of the OPA GMT ratio (V114/ Prevnar 13™) to be greater than 0.5.|GMT Ratio|1.18|||<|0.001|TWO_SIDED|95.0|0.96|1.44|||cLDA|GMT ratio, 95% CI, and p-value are estimated from a cLDA model.||Serotype 23F (Shared)||1.44|0.96|<0.001
72440232|NCT03950622|144393714|SUPERIORITY|The statistical criterion for superiority requires the lower bound of the 2-sided 95% CI of the OPA GMT ratio \[V114/ Prevnar 13™\] to be greater than 2.0.|GMT Ratio|31.83|||<|0.001|TWO_SIDED|95.0|25.35|39.97|||cLDA|GMT ratio, 95% CI, and p-value are estimated from a cLDA model.||Serotype 22F (Unique to V114)||39.97|25.35|<0.001
72440233|NCT03950622|144393714|SUPERIORITY|The statistical criterion for superiority requires the lower bound of the 2-sided 95% CI of the OPA GMT ratio \[V114/ Prevnar 13™\] to be greater than 2.0.|GMT Ratio|7.11|||<|0.001|TWO_SIDED|95.0|6.07|8.32|||cLDA|GMT ratio, 95% CI, and p-value are estimated from a cLDA model.||Serotype 33F (Unique to V114)||8.32|6.07|<0.001
72440234|NCT03950622|144393715|SUPERIORITY|The statistical criterion for superiority requires the lower bound of the 2-sided 95% CI of the differences \[V114 - Prevnar 13™\] between the proportions of participants with a ≥4-fold rise from prevaccination \[Day 1\] to 30 days postvaccination \[Day 30\] to be greater than 0.1.|Percentage Point Difference|57.1|||<|0.001|TWO_SIDED|95.0|52.0|61.8|||Miettinen & Nurminen|Estimated difference, 95% CI, and p-value are based on the stratified Miettinen \& Nurminen method.||Serotype 22F (Unique to V114)||61.8|52.0|<0.001
72440235|NCT03950622|144393715|SUPERIORITY|The statistical criterion for superiority requires the lower bound of the 2-sided 95% CI of the differences \[V114 - Prevnar 13™\] between the proportions of participants with a ≥4-fold rise from prevaccination \[Day 1\] to 30 days postvaccination \[Day 30\] to be greater than 0.1)|Percentage Point Difference|50.5|||<|0.001|TWO_SIDED|95.0|45.9|54.9|||Miettinen & Nurminen|Estimated difference, 95% CI, and p-value are based on the stratified Miettinen \& Nurminen method.||Serotype 33F (Unique to V114)||54.9|45.9|<0.001
72440236|NCT03950622|144393716|SUPERIORITY|The statistical criterion for superiority requires the lower bound of the 2-sided 95% CI of the OPA GMT ratio \[V114/ Prevnar 13™\] to be greater than 1.2.|GMT Ratio|1.6|||<|0.001|TWO_SIDED|95.0|1.38|1.85|||cLDA|GMT ratio, 95% CI, and p-value are estimated from a cLDA model.||Serotype 3 (Shared)||1.85|1.38|<0.001
72440237|NCT03950622|144393717|SUPERIORITY|The statistical criterion for superiority requires the lower bound of the 2-sided 95% CI of the difference(V114 - Prevnar 13™) between the proportions of participants with a ≥4-fold rise from prevaccination (Day 1) to 30 days postvaccination (Day 30) to be greater than 0.|Percentage Point Difference|11.5|||<|0.001|TWO_SIDED|95.0|6.0|16.9|||Miettinen & Nurminen|Estimated difference, 95% CI, and p-value are based on the stratified Miettinen \& Nurminen method.||Serotype 3 (Shared) ≥4-Fold Rise in OPA||16.9|6.0|<0.001
72440238|NCT03950622|144393718|OTHER|GMC ratio and 95% CI are estimated from a constrained longitudinal data analysis (cLDA) model.|GMC Ratio|0.72|||||TWO_SIDED|95.0|0.62|0.83||||||Serotype 1 (Shared)||0.83|0.62|
72440239|NCT03950622|144393718|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|1.51|||||TWO_SIDED|95.0|1.33|1.71||||||Serotype 3 (Shared)||1.71|1.33|
72440240|NCT03950622|144393718|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|0.72|||||TWO_SIDED|95.0|0.62|0.83||||||Serotype 4 (Shared)||0.83|0.62|
72440241|NCT03950622|144393718|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|0.82|||||TWO_SIDED|95.0|0.7|0.96||||||Serotype 5 (Shared)||0.96|0.70|
72440242|NCT03950622|144393718|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|1.03|||||TWO_SIDED|95.0|0.87|1.21||||||Serotype 6A (Shared)||1.21|0.87|
72440243|NCT03950622|144393718|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|1.39|||||TWO_SIDED|95.0|1.17|1.64||||||Serotype 6B (Shared)||1.64|1.17|
72440244|NCT03950622|144393718|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|0.76|||||TWO_SIDED|95.0|0.66|0.89||||||Serotype 7F (Shared)||0.89|0.66|
72559140|NCT01634139|144648072|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.124|STANDARD_ERROR_OF_MEAN|0.031|<|0.0001|TWO_SIDED|95.0|0.062|0.185|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|||0.185|0.062|<0.0001
72559141|NCT01634139|144648072|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.127|STANDARD_ERROR_OF_MEAN|0.031|<|0.0001|TWO_SIDED|95.0|0.065|0.188|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|||0.188|0.065|<0.0001
72559142|NCT01634139|144648073|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.154|STANDARD_ERROR_OF_MEAN|0.03|<|0.0001|TWO_SIDED|95.0|0.095|0.212|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 24||0.212|0.095|<0.0001
72440245|NCT03950622|144393718|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|0.86|||||TWO_SIDED|95.0|0.75|1.0||||||Serotype 9V (Shared)||1.00|0.75|
72440246|NCT03950622|144393718|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|0.76|||||TWO_SIDED|95.0|0.65|0.89||||||Serotype 14 (Shared)||0.89|0.65|
72440247|NCT03950622|144393718|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|0.9|||||TWO_SIDED|95.0|0.77|1.05||||||Serotype 18C (Shared)||1.05|0.77|
72440248|NCT03950622|144393718|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|0.84|||||TWO_SIDED|95.0|0.73|0.97||||||Serotype 19A (Shared)||0.97|0.73|
72440249|NCT03950622|144393718|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|0.9|||||TWO_SIDED|95.0|0.78|1.05||||||Serotype 19F (Shared)||1.05|0.78|
72440250|NCT03950622|144393718|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|1.09|||||TWO_SIDED|95.0|0.92|1.28||||||Serotype 23F (Shared)||1.28|0.92|
72440251|NCT03950622|144393718|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|10.62|||||TWO_SIDED|95.0|9.37|12.03||||||Serotype 22F (Unique to V114)||12.03|9.37|
72440252|NCT03950622|144393718|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|8.98|||||TWO_SIDED|95.0|8.0|10.07||||||Serotype 33F (Unique to V114)||10.07|8.00|
72440253|NCT03752151|144393723|SUPERIORITY||||||<|0.001|||||||McNemar|||The null hypothesis was that the probability of meeting the endpoint (Atrioventricular synchrony \>70%) was the same in MARVEL 2 Monitor Mode and MARVEL 2 Adaptive Mode. A sample size of 35 participants with a predominant rhythm of 3rd degree atrioventricular block and normal sinus function provided \>90% power at a type I error rate of 0.05 assuming the proportion of patients meeting the endpoint in one mode, but not the other exceeded 50% and 90% of these pairs favored the Adaptive mode.||||<0.001
72440254|NCT03752151|144393724|SUPERIORITY||proportion expressed as a percentage|100.0|||<|0.001|TWO_SIDED|95.0|95.2|100.0|||Exact binomial test|||The null hypothesis is that 87% or fewer participants will achieve the endpoint. The alternative hypothesis is that more than 87% of participants will achieve the endpoint. A sample size of 70 participants provides at least 90% power to test the null hypothesis assuming the true rate of meeting the endpoint in the population is 98% at a type I error rate of 2.5%.||100|95.2|<0.001
72440255|NCT03752151|144393725|SUPERIORITY||Mean Difference (Final Values)|1.7||||0.002|TWO_SIDED|95.0|0.7|2.7|||t-test, 2 sided|Paired t-test since each participant had LVOT VTI measurements in MARVEL 2 Adaptive and Monitor modes||The null hypothesis is that the mean LVOT VTI during MARVEL 2 Adaptive mode equals the mean LVOT VTI during MARVEL 2 Monitor mode. A sample size of 35 participants with paired LVOT VTI measurements provides 89% power at a type I error rate of 5% to reject the null hypothesis assuming the true difference in LVOT VTI is 2.1 cm with a standard deviation of 3.8 cm.||2.7|0.7|0.002
72440256|NCT03074331|144393777|SUPERIORITY|||||||0.009|||||||2-sided exact 1-sample binomial test|||The SVR12 rate was compared to the pre-specified performance goal of 85% by using a two-sided exact one-sample binomial test at the 0.05 significance level.||||0.009
72440257|NCT01546753|144393788|SUPERIORITY|The change from baseline OFC to week 38 OFC (primary outcome measure) was compared between the two groups using a Mann-Whitney U test.||||||0.001|||||||Wilcoxon (Mann-Whitney)|||||||0.001
72440258|NCT01546753|144393789|SUPERIORITY|Differences in dichotomous outcomes for the percentage of participants who reach the 5000 mg cumulative dose to the walnut at the week 38 desensitization OFC was analyzed using Fisher's exact test||||||0.01|||||||Fisher Exact|||||||0.01
72440259|NCT01546753|144393790|SUPERIORITY|Differences in dichotomous outcomes including the percentage of subjects who reach the 2000 mg cumulative dose to the walnut at the week 38 desensitization OFC was analyzed using Fisher's exact test|||||<|0.01|||||||Fisher Exact|||||||<0.01
72440260|NCT01546753|144393791|SUPERIORITY|Differences in dichotomous outcomes such as the percentage of subjects who reach the 2000 mg cumulative dose to the tree nut at the week 38 desensitization OFC was analyzed using Fisher's exact test|||||<|0.01|||||||Fisher Exact|||||||<0.01
72440261|NCT01546753|144393793|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||<0.001
72440262|NCT01796236|144393800|SUPERIORITY_OR_OTHER|||||||0.12|||||||Mantel Haenszel|||||||0.12
72440263|NCT01796236|144393801|SUPERIORITY_OR_OTHER|||||||0.45|||||||Mantel Haenszel|||"Combined Endpoint is calculated as the sum of the following four events from 3 weeks to 3 years:~Holgers Index \>=2. Any Overgrowth \>=2. Pain (scar/neuropathic) \>=3. Any numbness \>=2.~Each event is counted only once"||||0.45
72440264|NCT01796236|144393802|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mann-Whitney U test|||||||<0.0001
72440265|NCT01796236|144393803|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED||||||Fisher Exact|||Day 10||||0.020
72504657|NCT02495077|144540086|SUPERIORITY||Mean Difference (Final Values)|-1.56||||0.51|TWO_SIDED|95.0|-6.22|3.1|||Mixed Models Analysis|||Day 30. Mean eGFR of the two treatment groups was compared. The p-value, estimated day 30 eGFR within each treatment group, estimate of the treatment group difference, and estimated 95% confidence interval result from a repeated measures mixed model using available eGFR data from months 1, 3, 6, 12, 18, and 24 to compare the experimental group to the control group at day 30. Random effects for the intercept and eGFR collection day were utilized in the model.||3.10|-6.22|0.510
72559143|NCT01634139|144648073|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.157|STANDARD_ERROR_OF_MEAN|0.03|<|0.0001|TWO_SIDED|95.0|0.098|0.215|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 24||0.215|0.098|<0.0001
72440266|NCT01796236|144393803|SUPERIORITY_OR_OTHER|||||||0.4|||||||Fisher Exact|||Week 3||||0.4
72440267|NCT01796236|144393803|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||Week 6||||1.00
72440268|NCT01796236|144393803|SUPERIORITY_OR_OTHER|||||||0.97|||||||Fisher Exact|||Week 12||||0.97
72440269|NCT01796236|144393803|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||Week 24||||1.00
72440270|NCT01796236|144393804|SUPERIORITY_OR_OTHER|||||||0.4|||||||Mantel Haenszel|||Maximum of Holgers at 12 Months||||0.40
72440271|NCT01796236|144393804|SUPERIORITY_OR_OTHER|||||||0.14|||||||Mantel Haenszel|||Maximum of Holgers at 36 Months||||0.14
72440272|NCT01796236|144393805|SUPERIORITY_OR_OTHER|||||||0.38|||||||Mantel Haenszel|||Holgers Index Day 10||||0.38
72440273|NCT01796236|144393805|SUPERIORITY_OR_OTHER|||||||0.17|||||||Mantel Haenszel|||Holgers Index Week 3||||0.17
72440274|NCT01796236|144393805|SUPERIORITY_OR_OTHER|||||||0.37|||||||Mantel Haenszel|||Holgers Index Week 6||||0.37
72440275|NCT01796236|144393805|SUPERIORITY_OR_OTHER|||||||0.73|||||||Mantel Haenszel|||Holgers Index Week 12||||0.73
72440276|NCT01796236|144393805|SUPERIORITY_OR_OTHER|||||||0.47|||||||Mantel Haenszel|||Holgers Index Week 24||||0.47
72440277|NCT01796236|144393805|SUPERIORITY_OR_OTHER|||||||0.73|||||||Mantel Haenszel|||Holgers Index Month 12||||0.73
72440278|NCT01796236|144393805|SUPERIORITY_OR_OTHER|||||||0.37|||||||Mantel Haenszel|||Holgers Index Month 24||||0.37
72440279|NCT01796236|144393805|SUPERIORITY_OR_OTHER|||||||0.75|||||||Mantel Haenszel|||Holgers Index Month 36||||0.75
72440280|NCT01796236|144393806|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mantel Haenszel|||maximum numbness at 12 months||||<0.0001
72440281|NCT01796236|144393806|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mantel Haenszel|||maximum numbness at 36 months||||<0.0001
72440282|NCT01796236|144393807|SUPERIORITY_OR_OTHER|||||||0.74|||||||Wilcoxon (Mann-Whitney)|||Day 10, Neuropathic pain||||0.74
72440283|NCT01796236|144393807|SUPERIORITY_OR_OTHER|||||||0.36|||||||Wilcoxon (Mann-Whitney)|||Day 10, Scar pain||||0.36
72440284|NCT01796236|144393807|SUPERIORITY_OR_OTHER|||||||0.03|||||||Wilcoxon (Mann-Whitney)|||Week 3, Neuropathic pain||||0.030
72440285|NCT01796236|144393807|SUPERIORITY_OR_OTHER|||||||0.92|||||||Wilcoxon (Mann-Whitney)|||Week 3, Scar pain||||0.92
72440286|NCT01796236|144393807|SUPERIORITY_OR_OTHER|||||||0.15|||||||Wilcoxon (Mann-Whitney)|||Week 6, Neuropathic pain||||0.15
72440287|NCT01796236|144393807|SUPERIORITY_OR_OTHER|||||||0.38|||||||Wilcoxon (Mann-Whitney)|||Week 6, Scar pain||||0.38
72440288|NCT01796236|144393807|SUPERIORITY_OR_OTHER|||||||0.015|||||||Wilcoxon (Mann-Whitney)|||Week 12, Neuropathic pain||||0.015
72440289|NCT01796236|144393807|SUPERIORITY_OR_OTHER|||||||0.72|||||||Wilcoxon (Mann-Whitney)|||Week 12, Scar pain||||0.72
72440290|NCT01796236|144393807|SUPERIORITY_OR_OTHER|||||||0.44|||||||Wilcoxon (Mann-Whitney)|||Week 24, Neuropathic pain||||0.44
72440291|NCT01796236|144393807|SUPERIORITY_OR_OTHER|||||||0.43|||||||Wilcoxon (Mann-Whitney)|||Week 24, Scar pain||||0.43
72440292|NCT01796236|144393807|SUPERIORITY_OR_OTHER|||||||0.21|||||||Wilcoxon (Mann-Whitney)|||Month 12, Neuropathic pain||||0.21
72440293|NCT01796236|144393807|SUPERIORITY_OR_OTHER|||||||0.97|||||||Wilcoxon (Mann-Whitney)|||Month 12, Scar pain||||0.97
72440294|NCT01796236|144393807|SUPERIORITY_OR_OTHER|||||||0.19|||||||Wilcoxon (Mann-Whitney)|||Month 36, Neuropathic pain||||0.19
72440295|NCT01796236|144393807|SUPERIORITY_OR_OTHER|||||||0.77|||||||Wilcoxon (Mann-Whitney)|||Month 36, Scar pain||||0.77
72440296|NCT01796236|144393808|SUPERIORITY_OR_OTHER|||||||0.076|||||||Mantel Haenszel|||Neuropathic Categorical Max Pain||||0.076
72440297|NCT01796236|144393808|SUPERIORITY_OR_OTHER|||||||0.49|||||||Mantel Haenszel|||Scar Categorical Max Pain||||0.49
72440298|NCT01796236|144393809|SUPERIORITY_OR_OTHER|||||||0.076|||||||Mantel Haenszel|||Neuropathic Categorical Max Pain 36 months||||0.076
72440299|NCT01796236|144393809|SUPERIORITY_OR_OTHER|||||||0.71|||||||Mantel Haenszel|||Scar Categorical Max Pain 36 months||||0.71
72440300|NCT01796236|144393810|SUPERIORITY_OR_OTHER|||||||0.52|||||||Cochran-Mantel-Haenszel|||Day 10: Neuropathic pain||||0.52
72440301|NCT01796236|144393810|SUPERIORITY_OR_OTHER|||||||0.44|||||||Cochran-Mantel-Haenszel|||Day 10: Scar pain||||0.44
72440302|NCT01796236|144393810|SUPERIORITY_OR_OTHER|||||||0.14|||||||Cochran-Mantel-Haenszel|||Week 3: Neuropathic pain||||0.14
72440303|NCT01796236|144393810|SUPERIORITY_OR_OTHER|||||||0.59|||||||Cochran-Mantel-Haenszel|||Week 3: Scar pain||||0.59
72440304|NCT01796236|144393810|SUPERIORITY_OR_OTHER|||||||0.17|||||||Cochran-Mantel-Haenszel|||Week 6: Neuropathic pain||||0.17
72440305|NCT01796236|144393810|SUPERIORITY_OR_OTHER|||||||0.44|||||||Cochran-Mantel-Haenszel|||Week 6: Scar pain||||0.44
72495945|NCT02167945|144521515|SUPERIORITY||Cox Proportional Hazard Ratio|0.126|||<|0.001|TWO_SIDED|95.0|0.044|0.358|||Cox proportional hazards model||The estimated value represents the hazard ratio for developing the event in the group of participants in studies M14-222 and M14-423 who achieved SVR12 compared to the group of participants in studies M14-222 and M14-423 who didn't achieve SVR12.|A Cox proportional hazards (PH) model was constructed. The covariates for the model included baseline age, BMI, HCV genotype 1 subtype (1b, non-1b), IL28B genotype (CC, non-CC), prior treatment history (naive, experienced), baseline HCV RNA levels, baseline fibrosis stage (F0-1, F2, F3, F4), baseline albumin, baseline creatinine clearance, baseline platelet count, history of diabetes (yes, no), APRI, race (white, other), and alcohol use status (current, former, non-drinker).||0.358|0.044|<0.001
72495946|NCT02167945|144521516|SUPERIORITY||||||<|0.001|||||||Log-rank test|||Comparisons between participants in studies M14-222 and M14-423 who achieved SVR12 and those who did not were performed using a log-rank test.||||<0.001
72495947|NCT02167945|144521516|SUPERIORITY||Cox Proportional Hazard Ratio|0.031||||0.007|TWO_SIDED|95.0|0.003|0.38|||Cox proportional hazards model||The estimated value represents the hazard ratio for developing the event in the group of participants in studies M14-222 and M14-423 who achieved SVR12 compared to the group of participants in studies M14-222 and M14-423 who didn't achieve SVR12.|A Cox proportional hazards (PH) model was constructed. The covariates for the model included baseline age, BMI, HCV genotype 1 subtype (1b, non-1b), IL28B genotype (CC, non-CC), prior treatment history (naive, experienced), baseline HCV RNA levels, baseline fibrosis stage (F0-1, F2, F3, F4), baseline albumin, baseline creatinine clearance, baseline platelet count, history of diabetes (yes, no), APRI, race (white, other), and alcohol use status (current, former, non-drinker).||0.380|0.003|0.007
72495948|NCT02167945|144521517|SUPERIORITY||||||<|0.001|||||||Log-rank test|||Comparisons between participants in studies M14-222 and M14-423 who achieved SVR12 and those who did not were performed using a log-rank test.||||<0.001
72504658|NCT02495077|144540086|SUPERIORITY||Mean Difference (Final Values)|-1.85||||0.43|TWO_SIDED|95.0|-6.45|2.76|||Mixed Models Analysis|||Day 90. Mean eGFR of the two treatment groups was compared. The p-value, estimated day 90 eGFR within each treatment group, estimate of the treatment group difference, and estimated 95% confidence interval result from a repeated measures mixed model using available eGFR data from months 1, 3, 6, 12, 18, and 24 to compare the experimental group to the control group at day 90. Random effects for the intercept and eGFR collection day were utilized in the model.||2.76|-6.45|0.430
72440306|NCT01796236|144393810|SUPERIORITY_OR_OTHER|||||||0.0087|||||||Cochran-Mantel-Haenszel|||Week 12: Neuropathic pain||||0.0087
72440307|NCT01796236|144393810|SUPERIORITY_OR_OTHER|||||||0.84|||||||Cochran-Mantel-Haenszel|||Week 12: Scar pain||||0.84
72440308|NCT01796236|144393810|SUPERIORITY_OR_OTHER|||||||0.43|||||||Cochran-Mantel-Haenszel|||Week 24: Neuropathic pain||||0.43
72440309|NCT01796236|144393810|SUPERIORITY_OR_OTHER|||||||0.33|||||||Cochran-Mantel-Haenszel|||Week 24: Scar pain||||0.33
72440310|NCT01796236|144393810|SUPERIORITY_OR_OTHER|||||||0.21|||||||Cochran-Mantel-Haenszel|||Month 12 Neuropathic pain||||0.21
72440311|NCT01796236|144393810|SUPERIORITY_OR_OTHER|||||||0.82|||||||Cochran-Mantel-Haenszel|||Month 12 Scar pain||||0.82
72440312|NCT01796236|144393810|SUPERIORITY_OR_OTHER|||||||0.19|||||||Cochran-Mantel-Haenszel|||Month 36 Neuropathic pain||||0.19
72440313|NCT01796236|144393810|SUPERIORITY_OR_OTHER|||||||0.77|||||||Cochran-Mantel-Haenszel|||Month 36 Scar pain||||0.77
72440314|NCT01796236|144393811|SUPERIORITY_OR_OTHER|||||||0.12|||||||Mantel Haenszel|||Day 10 Soft tissue thickening/overgrowth||||0.12
72440315|NCT01796236|144393811|SUPERIORITY_OR_OTHER|||||||0.016|||||||Mantel Haenszel|||Week 3 Soft tissue thickening/overgrowth||||0.016
72440316|NCT01796236|144393811|SUPERIORITY_OR_OTHER|||||||0.84|||||||Mantel Haenszel|||Week 6 Soft tissue thickening/overgrowth||||0.84
72440317|NCT01796236|144393811|SUPERIORITY_OR_OTHER|||||||0.53|||||||Mantel Haenszel|||Week 12 Soft tissue thickening/overgrowth||||0.53
72440318|NCT01796236|144393811|SUPERIORITY_OR_OTHER|||||||0.18|||||||Mantel Haenszel|||Week 24 Soft tissue thickening/overgrowth||||0.18
72440319|NCT01796236|144393811|SUPERIORITY_OR_OTHER|||||||0.63|||||||Mantel Haenszel|||Month 12 Soft tissue thickening/overgrowth||||0.63
72440320|NCT01796236|144393811|SUPERIORITY_OR_OTHER|||||||0.81|||||||Mantel Haenszel|||Month 24 Soft tissue thickening/overgrowth||||0.81
72440321|NCT01796236|144393811|SUPERIORITY_OR_OTHER|||||||1|||||||Mantel Haenszel|||Month 36 Soft tissue thickening/overgrowth||||1.00
72440322|NCT01796236|144393812|SUPERIORITY_OR_OTHER|||||||0.0009|||||||Wilcoxon (Mann-Whitney)|||Visible Abutment Length Day 10||||0.0009
72440323|NCT01796236|144393812|SUPERIORITY_OR_OTHER|||||||0.008|||||||Wilcoxon (Mann-Whitney)|||Visible Abutment Length Week 3||||0.0080
72440324|NCT01796236|144393812|SUPERIORITY_OR_OTHER|||||||0.46|||||||Wilcoxon (Mann-Whitney)|||Visible Abutment Length Week 6||||0.46
72440325|NCT01796236|144393812|SUPERIORITY_OR_OTHER|||||||0.45|||||||Wilcoxon (Mann-Whitney)|||Visible Abutment Length Week 12||||0.45
72440326|NCT01796236|144393812|SUPERIORITY_OR_OTHER|||||||0.18|||||||Wilcoxon (Mann-Whitney)|||Visible Abutment Length Week 24||||0.18
72440327|NCT01796236|144393812|SUPERIORITY_OR_OTHER|||||||0.017|||||||Wilcoxon (Mann-Whitney)|||Visible Abutment Length Month 12||||0.017
72440328|NCT01796236|144393812|SUPERIORITY_OR_OTHER|||||||0.15|||||||Wilcoxon (Mann-Whitney)|||Visible Abutment Length Month 24||||0.15
72440329|NCT01796236|144393812|SUPERIORITY_OR_OTHER|||||||0.32|||||||Wilcoxon (Mann-Whitney)|||Visible Abutment Length Month 36||||0.32
72440330|NCT01796236|144393812|SUPERIORITY_OR_OTHER|||||||0.74|||||||Sign test|||Change in Visible Test Abutment - Week 3 change from day 10||||0.74
72440331|NCT01796236|144393812|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Sign test|||Change in Visible Test Abutment - Week 6 change from day 10||||<0.0001
72440332|NCT01796236|144393812|SUPERIORITY_OR_OTHER|||||||0.041|||||||Sign test|||Change in Visible Test Abutment - Week 12 change from day 10||||0.041
72440333|NCT01796236|144393812|SUPERIORITY_OR_OTHER|||||||0.0065|||||||Sign test|||Change in Visible Test Abutment - Week 24 change from day 10||||0.0065
72440334|NCT01796236|144393812|SUPERIORITY_OR_OTHER|||||||0.0003|||||||Sign test|||Change in Visible Test Abutment - Month 12 change from day 10||||0.0003
72440335|NCT01796236|144393812|SUPERIORITY_OR_OTHER|||||||0.028|||||||Sign test|||Change in Visible Test Abutment - Month 24 change from day 10||||0.028
72440336|NCT01796236|144393812|SUPERIORITY_OR_OTHER|||||||0.037|||||||Sign test|||Change in Visible Test Abutment - Month 36 change from day 10||||0.037
72440337|NCT01796236|144393812|SUPERIORITY_OR_OTHER|||||||0.072|||||||Sign test|||Change in Visible Control Abutment - Week 3 change from day 10||||0.072
72440338|NCT01796236|144393812|SUPERIORITY_OR_OTHER|||||||0.034|||||||Sign test|||Change in Visible Control Abutment - Week 6 change from day 10||||0.034
72495949|NCT02167945|144521517|SUPERIORITY||Cox Proportional Hazard Ratio|0.038|||<|0.001|TWO_SIDED|95.0|0.009|0.156|||Cox proportional hazards model||The estimated value represents the hazard ratio for developing the event in the group of participants in studies M14-222 and M14-423 who achieved SVR12 compared to the group of participants in studies M14-222 and M14-423 who didn't achieve SVR12.|A Cox proportional hazards (PH) model was constructed. The covariates for the model included baseline age, BMI, HCV genotype 1 subtype (1b, non-1b), IL28B genotype (CC, non-CC), prior treatment history (naive, experienced), baseline HCV RNA levels, baseline fibrosis stage (F0-1, F2, F3, F4), baseline albumin, baseline creatinine clearance, baseline platelet count, history of diabetes (yes, no), APRI, race (white, other), and alcohol use status (current, former, non-drinker).||0.156|0.009|<0.001
72495950|NCT02167945|144521518|SUPERIORITY|||||||0.86|||||||Log-rank test|||Comparisons between participants in studies M14-222 and M14-423 who achieved SVR12 and those who did not were performed using a log-rank test.||||0.860
72495951|NCT02167945|144521518|SUPERIORITY|||||||0.997||||||The Hazard Ratio for experiencing the event in the group of participants in studies M14-222 and M14-423 who achieved SVR12 compared to those who did not achieve SVR12 is infinite and the CI is not bounded due to zero events in one of the groups.|Cox proportional hazards model|||A Cox proportional hazards (PH) model was constructed. The covariates for the model included baseline age, BMI, HCV genotype 1 subtype (1b, non-1b), IL28B genotype (CC, non-CC), prior treatment history (naive, experienced), baseline HCV RNA levels, baseline fibrosis stage (F0-1, F2, F3, F4), baseline albumin, baseline creatinine clearance, baseline platelet count, history of diabetes (yes, no), APRI, race (white, other), and alcohol use status (current, former, non-drinker).||||0.997
72495952|NCT02167945|144521519|SUPERIORITY|||||||0.608|||||||Log-rank test|||Comparisons between participants in studies M14-222 and M14-423 who achieved SVR12 and those who did not were performed using a log-rank test.||||0.608
72440339|NCT01796236|144393812|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Sign test|||Change in Visible Control Abutment - Week 12 change from day 10||||<0.0001
72440340|NCT01796236|144393812|SUPERIORITY_OR_OTHER|||||||0.01|||||||Sign test|||Change in Visible Control Abutment - Week 24 change from day 10||||0.010
72440341|NCT01796236|144393812|SUPERIORITY_OR_OTHER|||||||0.0086|||||||Sign test|||Change in Visible Control Abutment - Month 12 change from day 10||||0.0086
72440342|NCT01796236|144393812|SUPERIORITY_OR_OTHER|||||||0.0021|||||||Sign test|||Change in Visible Control Abutment - Month 24 change from day 10||||0.0021
72440343|NCT01796236|144393812|SUPERIORITY_OR_OTHER|||||||0.0005|||||||Sign test|||Change in Visible Control Abutment - Month 36 change from day 10||||0.0005
72440344|NCT01796236|144393813|SUPERIORITY_OR_OTHER|||||||0.026|||||||Wilcoxon (Mann-Whitney)|||Week 12: Vascularity (observer)||||0.026
72440345|NCT01796236|144393813|SUPERIORITY_OR_OTHER|||||||0.33|||||||Wilcoxon (Mann-Whitney)|||Month 12: Vascularity (observer)||||0.33
72440346|NCT01796236|144393813|SUPERIORITY_OR_OTHER|||||||0.094|||||||Wilcoxon (Mann-Whitney)|||Month 36: Vascularity (observer)||||0.094
72440347|NCT01796236|144393813|SUPERIORITY_OR_OTHER|||||||0.3|||||||Wilcoxon (Mann-Whitney)|||Week 12: Pigmentation (observer)||||0.30
72440348|NCT01796236|144393813|SUPERIORITY_OR_OTHER|||||||0.23|||||||Wilcoxon (Mann-Whitney)|||Month 12: Pigmentation (observer)||||0.23
72440349|NCT01796236|144393813|SUPERIORITY_OR_OTHER|||||||0.48|||||||Wilcoxon (Mann-Whitney)|||Month 36: Pigmentation (observer)||||0.48
72440350|NCT01796236|144393813|SUPERIORITY_OR_OTHER|||||||0.0003|||||||Wilcoxon (Mann-Whitney)|||Week 12: Thickness (observer)||||0.0003
72440351|NCT01796236|144393813|SUPERIORITY_OR_OTHER|||||||0.062|||||||Wilcoxon (Mann-Whitney)|||Month 12: Thickness (observer)||||0.062
72440352|NCT01796236|144393813|SUPERIORITY_OR_OTHER|||||||0.11|||||||Wilcoxon (Mann-Whitney)|||Month 36: Thickness (observer)||||0.11
72440353|NCT01796236|144393813|SUPERIORITY_OR_OTHER|||||||0.0003|||||||Wilcoxon (Mann-Whitney)|||Week 12: Relief (observer)||||0.0003
72440354|NCT01796236|144393813|SUPERIORITY_OR_OTHER|||||||0.079|||||||Wilcoxon (Mann-Whitney)|||Month 12: Relief (observer)||||0.079
72440355|NCT01796236|144393813|SUPERIORITY_OR_OTHER|||||||0.025|||||||Wilcoxon (Mann-Whitney)|||Month 36: Relief (observer)||||0.025
72440356|NCT01796236|144393813|SUPERIORITY_OR_OTHER|||||||0.002|||||||Wilcoxon (Mann-Whitney)|||Week 12: Pliability (observer)||||0.0020
72440357|NCT01796236|144393813|SUPERIORITY_OR_OTHER|||||||0.14|||||||Wilcoxon (Mann-Whitney)|||Month 12: Pliability (observer)||||0.14
72440358|NCT01796236|144393813|SUPERIORITY_OR_OTHER|||||||0.0014|||||||Wilcoxon (Mann-Whitney)|||Month 36: Pliability (observer)||||0.0014
72440359|NCT01796236|144393813|SUPERIORITY_OR_OTHER|||||||0.0001|||||||Wilcoxon (Mann-Whitney)|||Week 12: Surface Area (observer)||||0.0001
72440360|NCT01796236|144393813|SUPERIORITY_OR_OTHER|||||||0.023|||||||Wilcoxon (Mann-Whitney)|||Month 12: Surface Area (observer)||||0.023
72440361|NCT01796236|144393813|SUPERIORITY_OR_OTHER|||||||0.045|||||||Wilcoxon (Mann-Whitney)|||Month 36: Surface Area (observer)||||0.045
72440362|NCT01796236|144393813|SUPERIORITY_OR_OTHER|||||||0.0005|||||||Wilcoxon (Mann-Whitney)|||Week 12: Total Score (observer)||||0.0005
72440363|NCT01796236|144393813|SUPERIORITY_OR_OTHER|||||||0.085|||||||Wilcoxon (Mann-Whitney)|||Month 12: Total Score (observer)||||0.085
72440364|NCT01796236|144393813|SUPERIORITY_OR_OTHER|||||||0.03|||||||Wilcoxon (Mann-Whitney)|||Month 36: Total Score (observer)||||0.030
72559144|NCT01634139|144648074|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.116|STANDARD_ERROR_OF_MEAN|0.036||0.0012|TWO_SIDED|95.0|0.046|0.186|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|10 minutes pre-dose (Week 24)||0.186|0.046|0.0012
72559145|NCT01634139|144648074|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.118|STANDARD_ERROR_OF_MEAN|0.036||0.001|TWO_SIDED|95.0|0.048|0.188|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|10 minutes pre-dose (Week 24)||0.188|0.048|0.0010
72559146|NCT01634139|144648074|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.139|STANDARD_ERROR_OF_MEAN|0.032|<|0.0001|TWO_SIDED|95.0|0.076|0.201|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|30 minutes post-dose (Week 24)||0.201|0.076|<0.0001
72440365|NCT01796236|144393813|SUPERIORITY_OR_OTHER|||||||0.0015|||||||Wilcoxon (Mann-Whitney)|||Week 12: Overall Opinion (observer)||||0.0015
72440366|NCT01796236|144393813|SUPERIORITY_OR_OTHER|||||||0.076|||||||Wilcoxon (Mann-Whitney)|||Month 12: Overall Opinion (observer)||||0.076
72440367|NCT01796236|144393813|SUPERIORITY_OR_OTHER|||||||0.15|||||||Wilcoxon (Mann-Whitney)|||Month 36: Overall Opinion (observer)||||0.15
72440368|NCT01796236|144393813|SUPERIORITY_OR_OTHER|||||||0.72|||||||Wilcoxon (Mann-Whitney)|||Week 12: Painful (patient)||||0.72
72440369|NCT01796236|144393813|SUPERIORITY_OR_OTHER|||||||0.97|||||||Wilcoxon (Mann-Whitney)|||Month 12: Painful (patient)||||0.97
72440370|NCT01796236|144393813|SUPERIORITY_OR_OTHER|||||||0.82|||||||Wilcoxon (Mann-Whitney)|||Month 36: Painful (patient)||||0.82
72559147|NCT01634139|144648074|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.151|STANDARD_ERROR_OF_MEAN|0.032|<|0.0001|TWO_SIDED|95.0|0.088|0.213|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|30 minutes post-dose (Week 24)||0.213|0.088|<0.0001
72559148|NCT01634139|144648074|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.148|STANDARD_ERROR_OF_MEAN|0.032|<|0.0001|TWO_SIDED|95.0|0.084|0.211|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|1 hour post-dose (Week 24)||0.211|0.084|<0.0001
72440371|NCT01796236|144393813|SUPERIORITY_OR_OTHER|||||||0.86|||||||Wilcoxon (Mann-Whitney)|||Week 12: Itching (patient)||||0.86
72559149|NCT01634139|144648074|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.147|STANDARD_ERROR_OF_MEAN|0.032|<|0.0001|TWO_SIDED|95.0|0.084|0.21|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|1 hour post-dose (Week 24)||0.210|0.084|<0.0001
72559150|NCT01634139|144648074|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.163|STANDARD_ERROR_OF_MEAN|0.032|<|0.0001|TWO_SIDED|95.0|0.101|0.226|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|2 hours post-dose (Week 24)||0.226|0.101|<0.0001
72559151|NCT01634139|144648074|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.168|STANDARD_ERROR_OF_MEAN|0.032|<|0.0001||95.0|0.106|0.231|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|2 hours post-dose (Week 24)||0.231|0.106|<0.0001
72559152|NCT01634139|144648074|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.178|STANDARD_ERROR_OF_MEAN|0.032|<|0.0001|TWO_SIDED|95.0|0.116|0.24|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|3 hours post-dose (Week 24)||0.240|0.116|<0.0001
72559153|NCT01634139|144648074|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.176|STANDARD_ERROR_OF_MEAN|0.032|<|0.0001|TWO_SIDED|95.0|0.114|0.238|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|3 hours post-dose (Week 24)||0.238|0.114|<0.0001
72559154|NCT01634139|144648075|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.11|STANDARD_ERROR_OF_MEAN|0.038||0.0036|TWO_SIDED|95.0|0.036|0.184|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 24||0.184|0.036|0.0036
72559155|NCT01634139|144648075|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.091|STANDARD_ERROR_OF_MEAN|0.037||0.0152|TWO_SIDED|95.0|0.018|0.165|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 24||0.165|0.018|0.0152
72440372|NCT01796236|144393813|SUPERIORITY_OR_OTHER|||||||0.84|||||||Wilcoxon (Mann-Whitney)|||Month 12: Itching (patient)||||0.84
72440373|NCT01796236|144393813|SUPERIORITY_OR_OTHER|||||||0.76|||||||Wilcoxon (Mann-Whitney)|||Month 36: Itching (patient)||||0.76
72440374|NCT01796236|144393813|SUPERIORITY_OR_OTHER|||||||0.41|||||||Wilcoxon (Mann-Whitney)|||Week 12: Color (patient)||||0.41
72440375|NCT01796236|144393813|SUPERIORITY_OR_OTHER|||||||0.98|||||||Wilcoxon (Mann-Whitney)|||Month 12: Color (patient)||||0.98
72440376|NCT01796236|144393813|SUPERIORITY_OR_OTHER|||||||0.76|||||||Wilcoxon (Mann-Whitney)|||Month 36: Color (patient)||||0.76
72440377|NCT01796236|144393813|SUPERIORITY_OR_OTHER|||||||0.43|||||||Wilcoxon (Mann-Whitney)|||Week 12: Stiffness (patient)||||0.43
72440378|NCT01796236|144393813|SUPERIORITY_OR_OTHER|||||||0.25|||||||Wilcoxon (Mann-Whitney)|||Month 12: Stiffness (patient)||||0.25
72440379|NCT01796236|144393813|SUPERIORITY_OR_OTHER|||||||0.017|||||||Wilcoxon (Mann-Whitney)|||Month 36: Stiffness (patient)||||0.017
72440380|NCT01796236|144393813|SUPERIORITY_OR_OTHER|||||||0.13|||||||Wilcoxon (Mann-Whitney)|||Week 12: Thickness (patient)||||0.13
72440381|NCT01796236|144393813|SUPERIORITY_OR_OTHER|||||||0.33|||||||Wilcoxon (Mann-Whitney)|||Month 12: Thickness (patient)||||0.33
72440382|NCT01796236|144393813|SUPERIORITY_OR_OTHER|||||||0.65|||||||Wilcoxon (Mann-Whitney)|||Month 36: Thickness (patient)||||0.65
72440383|NCT01796236|144393813|SUPERIORITY_OR_OTHER|||||||0.18|||||||Wilcoxon (Mann-Whitney)|||Week 12: Irregularity (patient)||||0.18
72440384|NCT01796236|144393813|SUPERIORITY_OR_OTHER|||||||0.38|||||||Wilcoxon (Mann-Whitney)|||Month 12: Irregularity (patient)||||0.38
72440385|NCT01796236|144393813|SUPERIORITY_OR_OTHER|||||||0.08|||||||Wilcoxon (Mann-Whitney)|||Month 36: Irregularity (patient)||||0.080
72440386|NCT01796236|144393813|SUPERIORITY_OR_OTHER|||||||0.28|||||||Wilcoxon (Mann-Whitney)|||Week 12: Total Score (patient)||||0.28
72440387|NCT01796236|144393813|SUPERIORITY_OR_OTHER|||||||0.44|||||||Wilcoxon (Mann-Whitney)|||Month 12: Total Score (patient)||||0.44
72440388|NCT01796236|144393813|SUPERIORITY_OR_OTHER|||||||0.19|||||||Wilcoxon (Mann-Whitney)|||Month 36: Total Score (patient)||||0.19
72440389|NCT01796236|144393813|SUPERIORITY_OR_OTHER|||||||0.16|||||||Wilcoxon (Mann-Whitney)|||Week 12: Overall Opinion (patient)||||0.16
72440390|NCT01796236|144393813|SUPERIORITY_OR_OTHER|||||||0.23|||||||Wilcoxon (Mann-Whitney)|||Week 12: Overall Opinion (patient)||||0.23
72440391|NCT01796236|144393813|SUPERIORITY_OR_OTHER|||||||0.079|||||||Wilcoxon (Mann-Whitney)|||Month 36: Overall Opinion (patient)||||0.079
72440392|NCT01796236|144393813|SUPERIORITY_OR_OTHER|||||||0.0018|||||||Wilcoxon (Mann-Whitney)|||Week 12: Pain not within Scar (patient)||||0.0018
72440393|NCT01796236|144393813|SUPERIORITY_OR_OTHER|||||||0.053|||||||Wilcoxon (Mann-Whitney)|||Month 12: Pain not within Scar (patient)||||0.053
72440394|NCT01796236|144393813|SUPERIORITY_OR_OTHER|||||||0.068|||||||Wilcoxon (Mann-Whitney)|||Month 36: Pain not within Scar (patient)||||0.068
72440395|NCT01796236|144393814|SUPERIORITY_OR_OTHER|||||||0.9|||||||Wilcoxon (Mann-Whitney)|||Baseline: Comprehensive Health State (HUI3)||||0.90
72440396|NCT01796236|144393814|SUPERIORITY_OR_OTHER|||||||0.43|||||||Wilcoxon (Mann-Whitney)|||Week 24: Comprehensive Health State (HUI3)||||0.43
72440397|NCT01796236|144393814|SUPERIORITY_OR_OTHER|||||||0.23|||||||Wilcoxon (Mann-Whitney)|||Month 12: Comprehensive Health State (HUI3)||||0.23
72440398|NCT01796236|144393814|SUPERIORITY_OR_OTHER|||||||0.019|||||||Wilcoxon (Mann-Whitney)|||Month 36: Comprehensive Health State (HUI3)||||0.019
72440399|NCT01796236|144393814|SUPERIORITY_OR_OTHER|||||||0.079|||||||Wilcoxon (Mann-Whitney)|||Baseline: Vision (HUI3)||||0.079
72440400|NCT01796236|144393814|SUPERIORITY_OR_OTHER|||||||0.96|||||||Wilcoxon (Mann-Whitney)|||Week 24: Vision (HUI3)||||0.96
72440401|NCT01796236|144393814|SUPERIORITY_OR_OTHER|||||||0.55|||||||Wilcoxon (Mann-Whitney)|||Month 12: Vision (HUI3)||||0.55
72440402|NCT01796236|144393814|SUPERIORITY_OR_OTHER|||||||0.64|||||||Wilcoxon (Mann-Whitney)|||Month 36: Vision (HUI3)||||0.64
72440403|NCT01796236|144393814|SUPERIORITY_OR_OTHER|||||||0.76|||||||Wilcoxon (Mann-Whitney)|||Baseline: Hearing (HUI3)||||0.76
72440404|NCT01796236|144393814|SUPERIORITY_OR_OTHER|||||||0.059|||||||Wilcoxon (Mann-Whitney)|||Week 24: Hearing (HUI3)||||0.059
72440405|NCT01796236|144393814|SUPERIORITY_OR_OTHER|||||||0.38|||||||Wilcoxon (Mann-Whitney)|||Month 12: Hearing (HUI3)||||0.38
72440406|NCT01796236|144393814|SUPERIORITY_OR_OTHER|||||||0.14|||||||Wilcoxon (Mann-Whitney)|||Month 36: Hearing (HUI3)||||0.14
72440407|NCT01796236|144393814|SUPERIORITY_OR_OTHER|||||||0.73|||||||Wilcoxon (Mann-Whitney)|||Baseline: Speech (HUI3)||||0.73
72440408|NCT01796236|144393814|SUPERIORITY_OR_OTHER|||||||0.65|||||||Wilcoxon (Mann-Whitney)|||Week 24: Speech (HUI3)||||0.65
72440409|NCT01796236|144393814|SUPERIORITY_OR_OTHER|||||||1|||||||Wilcoxon (Mann-Whitney)|||Month 12: Speech (HUI3)||||1.00
72440410|NCT01796236|144393814|SUPERIORITY_OR_OTHER|||||||0.35|||||||Wilcoxon (Mann-Whitney)|||Month 36: Speech (HUI3)||||0.35
72440411|NCT01796236|144393814|SUPERIORITY_OR_OTHER|||||||0.5|||||||Wilcoxon (Mann-Whitney)|||Baseline: Ambulation (HUI3)||||0.50
72440412|NCT01796236|144393814|SUPERIORITY_OR_OTHER|||||||0.4|||||||Wilcoxon (Mann-Whitney)|||Week 24: Ambulation (HUI3)||||0.40
72440413|NCT01796236|144393814|SUPERIORITY_OR_OTHER|||||||0.21|||||||Wilcoxon (Mann-Whitney)|||Month 12: Ambulation (HUI3)||||0.21
72440414|NCT01796236|144393814|SUPERIORITY_OR_OTHER|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||Month 36: Ambulation (HUI3)||||0.0010
72440415|NCT01796236|144393814|SUPERIORITY_OR_OTHER|||||||0.13|||||||Wilcoxon (Mann-Whitney)|||Baseline: Emotion (HUI3)||||0.13
72440416|NCT01796236|144393814|SUPERIORITY_OR_OTHER|||||||0.96|||||||Wilcoxon (Mann-Whitney)|||Week 24: Emotion (HUI3)||||0.96
72440417|NCT01796236|144393814|SUPERIORITY_OR_OTHER|||||||0.75|||||||Wilcoxon (Mann-Whitney)|||Month 12: Emotion (HUI3)||||0.75
72440418|NCT01796236|144393814|SUPERIORITY_OR_OTHER|||||||0.2|||||||Wilcoxon (Mann-Whitney)|||Month 36: Emotion (HUI3)||||0.20
72440419|NCT01796236|144393814|SUPERIORITY_OR_OTHER|||||||0.95|||||||Wilcoxon (Mann-Whitney)|||Baseline: Cognition (HUI3)||||0.95
72440420|NCT01796236|144393814|SUPERIORITY_OR_OTHER|||||||0.31|||||||Wilcoxon (Mann-Whitney)|||Week 24: Cognition (HUI3)||||0.31
72440421|NCT01796236|144393814|SUPERIORITY_OR_OTHER|||||||0.15|||||||Wilcoxon (Mann-Whitney)|||Month 12: Cognition (HUI3)||||0.15
72440422|NCT01796236|144393814|SUPERIORITY_OR_OTHER|||||||0.19|||||||Wilcoxon (Mann-Whitney)|||Month 36: Cognition (HUI3)||||0.19
72440423|NCT01796236|144393814|SUPERIORITY_OR_OTHER|||||||0.41|||||||Wilcoxon (Mann-Whitney)|||Baseline: Pain (HUI3)||||0.41
72440424|NCT01796236|144393814|SUPERIORITY_OR_OTHER|||||||0.3|||||||Wilcoxon (Mann-Whitney)|||Week 24: Pain (HUI3)||||0.30
72440425|NCT01796236|144393814|SUPERIORITY_OR_OTHER|||||||0.42|||||||Wilcoxon (Mann-Whitney)|||Month 12: Pain (HUI3)||||0.42
72440426|NCT01796236|144393814|SUPERIORITY_OR_OTHER|||||||0.04|||||||Wilcoxon (Mann-Whitney)|||Month 36: Pain (HUI3)||||0.040
72440427|NCT01796236|144393814|SUPERIORITY_OR_OTHER|||||||0.99|||||||Wilcoxon (Mann-Whitney)|||Baseline: Comprehensive Health State (HUI2)||||0.99
72440428|NCT01796236|144393814|SUPERIORITY_OR_OTHER|||||||0.88|||||||Wilcoxon (Mann-Whitney)|||Week 24: Comprehensive Health State (HUI2)||||0.88
72440429|NCT01796236|144393814|SUPERIORITY_OR_OTHER|||||||0.32|||||||Wilcoxon (Mann-Whitney)|||Month 12: Comprehensive Health State (HUI2)||||0.32
72440430|NCT01796236|144393814|SUPERIORITY_OR_OTHER|||||||0.0084|||||||Wilcoxon (Mann-Whitney)|||Month 36: Comprehensive Health State (HUI2)||||0.0084
72440431|NCT01796236|144393814|SUPERIORITY_OR_OTHER|||||||0.77|||||||Wilcoxon (Mann-Whitney)|||Baseline: Sensation (HUI2)||||0.77
72440432|NCT01796236|144393814|SUPERIORITY_OR_OTHER|||||||0.95|||||||Wilcoxon (Mann-Whitney)|||Week 24: Sensation (HUI2)||||0.95
72440433|NCT01796236|144393814|SUPERIORITY_OR_OTHER|||||||0.6|||||||Wilcoxon (Mann-Whitney)|||Month 12: Sensation (HUI2)||||0.60
72440434|NCT01796236|144393814|SUPERIORITY_OR_OTHER|||||||0.48|||||||Wilcoxon (Mann-Whitney)|||Month 36: Sensation (HUI2)||||0.48
72440435|NCT01796236|144393814|SUPERIORITY_OR_OTHER|||||||0.51|||||||Wilcoxon (Mann-Whitney)|||Baseline: Mobility (HUI2)||||0.51
72440436|NCT01796236|144393814|SUPERIORITY_OR_OTHER|||||||0.42|||||||Wilcoxon (Mann-Whitney)|||Week 24: Mobility (HUI2)||||0.42
72440437|NCT01796236|144393814|SUPERIORITY_OR_OTHER|||||||0.22|||||||Wilcoxon (Mann-Whitney)|||Month 12: Mobility (HUI2)||||0.22
72440438|NCT01796236|144393814|SUPERIORITY_OR_OTHER|||||||0.0018|||||||Wilcoxon (Mann-Whitney)|||Month 36: Mobility (HUI2)||||0.0018
72440439|NCT01796236|144393814|SUPERIORITY_OR_OTHER|||||||0.3|||||||Wilcoxon (Mann-Whitney)|||Baseline: Emotion (HUI2)||||0.30
72440440|NCT01796236|144393814|SUPERIORITY_OR_OTHER|||||||0.52|||||||Wilcoxon (Mann-Whitney)|||Week 24: Emotion (HUI2)||||0.52
72440441|NCT01796236|144393814|SUPERIORITY_OR_OTHER|||||||0.47|||||||Wilcoxon (Mann-Whitney)|||Month 12: Emotion (HUI2)||||0.47
72440442|NCT01796236|144393814|SUPERIORITY_OR_OTHER|||||||0.18|||||||Wilcoxon (Mann-Whitney)|||Month 36: Emotion (HUI2)||||0.18
72440443|NCT01796236|144393814|SUPERIORITY_OR_OTHER|||||||0.82|||||||Wilcoxon (Mann-Whitney)|||Baseline: Cognition (HUI2)||||0.82
72440444|NCT01796236|144393814|SUPERIORITY_OR_OTHER|||||||0.41|||||||Wilcoxon (Mann-Whitney)|||Week 24: Cognition (HUI2)||||0.41
72440445|NCT01796236|144393814|SUPERIORITY_OR_OTHER|||||||0.14|||||||Wilcoxon (Mann-Whitney)|||Month 12: Cognition (HUI2)||||0.14
72440446|NCT01796236|144393814|SUPERIORITY_OR_OTHER|||||||0.25|||||||Wilcoxon (Mann-Whitney)|||Month 36: Cognition (HUI2)||||0.25
72440447|NCT01796236|144393814|SUPERIORITY_OR_OTHER|||||||0.59|||||||Wilcoxon (Mann-Whitney)|||Baseline: Self Care (HUI2)||||0.59
72440448|NCT01796236|144393814|SUPERIORITY_OR_OTHER|||||||1|||||||Wilcoxon (Mann-Whitney)|||Week 24: Self Care (HUI2)||||1.00
72440449|NCT01796236|144393814|SUPERIORITY_OR_OTHER|||||||0.55|||||||Wilcoxon (Mann-Whitney)|||Month 12: Self Care (HUI2)||||0.55
72440450|NCT01796236|144393814|SUPERIORITY_OR_OTHER|||||||0.14|||||||Wilcoxon (Mann-Whitney)|||Month 36: Self Care (HUI2)||||0.14
72440451|NCT01796236|144393814|SUPERIORITY_OR_OTHER|||||||0.75|||||||Wilcoxon (Mann-Whitney)|||Baseline: Pain (HUI2)||||0.75
72440452|NCT01796236|144393814|SUPERIORITY_OR_OTHER|||||||0.63|||||||Wilcoxon (Mann-Whitney)|||Week 24: Pain (HUI2)||||0.63
72559156|NCT01634139|144648075|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.069|STANDARD_ERROR_OF_MEAN|0.038||0.0687|TWO_SIDED|95.0|-0.005|0.143|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 48||0.143|-0.005|0.0687
72440453|NCT01796236|144393814|SUPERIORITY_OR_OTHER|||||||0.57|||||||Wilcoxon (Mann-Whitney)|||Month 12: Pain (HUI2)||||0.57
72440454|NCT01796236|144393814|SUPERIORITY_OR_OTHER|||||||0.019|||||||Wilcoxon (Mann-Whitney)|||Month 36: Pain (HUI2)||||0.019
72440455|NCT01796236|144393815|SUPERIORITY_OR_OTHER|||||||0.047|||||||Wilcoxon (Mann-Whitney)|||Baseline: Ease of Communication (Aided)||||0.047
72440456|NCT01796236|144393815|SUPERIORITY_OR_OTHER|||||||0.23|||||||Wilcoxon (Mann-Whitney)|||Baseline: Background Noise (Aided)||||0.23
72440457|NCT01796236|144393815|SUPERIORITY_OR_OTHER|||||||0.015|||||||Wilcoxon (Mann-Whitney)|||Baseline: Reverberation (Aided)||||0.015
72440458|NCT01796236|144393815|SUPERIORITY_OR_OTHER|||||||0.13|||||||Wilcoxon (Mann-Whitney)|||Baseline: Aversiveness (Aided)||||0.13
72440459|NCT01796236|144393815|SUPERIORITY_OR_OTHER|||||||0.041|||||||Wilcoxon (Mann-Whitney)|||Baseline: Global (Aided)||||0.041
72440460|NCT01796236|144393815|SUPERIORITY_OR_OTHER|||||||0.071|||||||Wilcoxon (Mann-Whitney)|||Baseline: Ease of Communication (Unaided)||||0.071
72440461|NCT01796236|144393815|SUPERIORITY_OR_OTHER|||||||0.75|||||||Wilcoxon (Mann-Whitney)|||Baseline: Background Noise (Unaided)||||0.75
72440462|NCT01796236|144393815|SUPERIORITY_OR_OTHER|||||||0.32|||||||Wilcoxon (Mann-Whitney)|||Baseline: Reverberation (Unaided)||||0.32
72440463|NCT01796236|144393815|SUPERIORITY_OR_OTHER|||||||0.24|||||||Wilcoxon (Mann-Whitney)|||Baseline: Aversiveness (Unaided)||||0.24
72440464|NCT01796236|144393815|SUPERIORITY_OR_OTHER|||||||0.24|||||||Wilcoxon (Mann-Whitney)|||Baseline: Global (Unaided)||||0.24
72440465|NCT01796236|144393815|SUPERIORITY_OR_OTHER|||||||0.12|||||||Wilcoxon (Mann-Whitney)|||Baseline: Ease of Communication (Benefit)||||0.12
72440466|NCT01796236|144393815|SUPERIORITY_OR_OTHER|||||||0.19|||||||Wilcoxon (Mann-Whitney)|||Baseline: Background Noise (Benefit)||||0.19
72440467|NCT01796236|144393815|SUPERIORITY_OR_OTHER|||||||0.055|||||||Wilcoxon (Mann-Whitney)|||Baseline: Reverberation (Benefit)||||0.055
72440468|NCT01796236|144393815|SUPERIORITY_OR_OTHER|||||||0.24|||||||Wilcoxon (Mann-Whitney)|||Baseline: Aversiveness (Benefit)||||0.24
72440469|NCT01796236|144393815|SUPERIORITY_OR_OTHER|||||||0.042|||||||Wilcoxon (Mann-Whitney)|||Baseline: Global (Benefit)||||0.042
72440470|NCT01796236|144393815|SUPERIORITY_OR_OTHER|||||||0.19|||||||Wilcoxon (Mann-Whitney)|||Week 24: Ease of Communication (Aided)||||0.19
72440471|NCT01796236|144393815|SUPERIORITY_OR_OTHER|||||||0.99|||||||Wilcoxon (Mann-Whitney)|||Week 24: Background Noise (Aided)||||0.99
72440472|NCT01796236|144393815|SUPERIORITY_OR_OTHER|||||||0.24|||||||Wilcoxon (Mann-Whitney)|||Week 24: Reverberation (Aided)||||0.24
72440473|NCT01796236|144393815|SUPERIORITY_OR_OTHER|||||||0.73|||||||Wilcoxon (Mann-Whitney)|||Week 24: Aversiveness (Aided)||||0.73
72440474|NCT01796236|144393815|SUPERIORITY_OR_OTHER|||||||0.39|||||||Wilcoxon (Mann-Whitney)|||Week 24: Global (Aided)||||0.39
72440475|NCT01796236|144393815|SUPERIORITY_OR_OTHER|||||||0.24|||||||Wilcoxon (Mann-Whitney)|||Week 24: Ease of Communication (Unaided)||||0.24
72440476|NCT01796236|144393815|SUPERIORITY_OR_OTHER|||||||0.81|||||||Wilcoxon (Mann-Whitney)|||Week 24: Background Noise (Unaided)||||0.81
72440477|NCT01796236|144393815|SUPERIORITY_OR_OTHER|||||||0.34|||||||Wilcoxon (Mann-Whitney)|||Week 24: Reverberation (Unaided)||||0.34
72440478|NCT01796236|144393815|SUPERIORITY_OR_OTHER|||||||0.038|||||||Wilcoxon (Mann-Whitney)|||Week 24: Aversiveness (Unaided)||||0.038
72440479|NCT01796236|144393815|SUPERIORITY_OR_OTHER|||||||0.53|||||||Wilcoxon (Mann-Whitney)|||Week 24: Global (Unaided)||||0.53
72440480|NCT01796236|144393815|SUPERIORITY_OR_OTHER|||||||0.63|||||||Wilcoxon (Mann-Whitney)|||Week 24: Ease of Communication (Benefit)||||0.63
72440481|NCT01796236|144393815|SUPERIORITY_OR_OTHER|||||||0.83|||||||Wilcoxon (Mann-Whitney)|||Week 24: Background Noise (Benefit)||||0.83
72440482|NCT01796236|144393815|SUPERIORITY_OR_OTHER|||||||0.71|||||||Wilcoxon (Mann-Whitney)|||Week 24: Reverberation (Benefit)||||0.71
72440483|NCT01796236|144393815|SUPERIORITY_OR_OTHER|||||||0.16|||||||Wilcoxon (Mann-Whitney)|||Week 24: Aversiveness (Benefit)||||0.16
72440484|NCT01796236|144393815|SUPERIORITY_OR_OTHER|||||||0.81|||||||Wilcoxon (Mann-Whitney)|||Week 24: Global (Benefit)||||0.81
72440485|NCT01796236|144393815|SUPERIORITY_OR_OTHER|||||||0.51|||||||Wilcoxon (Mann-Whitney)|||Month 12: Ease of Communication (Aided)||||0.51
72440486|NCT01796236|144393815|SUPERIORITY_OR_OTHER|||||||0.47|||||||Wilcoxon (Mann-Whitney)|||Month 12: Background Noise (Aided)||||0.47
72440487|NCT01796236|144393815|SUPERIORITY_OR_OTHER|||||||0.93|||||||Wilcoxon (Mann-Whitney)|||Month 12: Reverberation (Aided)||||0.93
72440488|NCT01796236|144393815|SUPERIORITY_OR_OTHER|||||||0.62|||||||Wilcoxon (Mann-Whitney)|||Month 12: Aversiveness (Aided)||||0.62
72440489|NCT01796236|144393815|SUPERIORITY_OR_OTHER|||||||0.63|||||||Wilcoxon (Mann-Whitney)|||Month 12: Global (Aided)||||0.63
72440490|NCT01796236|144393815|SUPERIORITY_OR_OTHER|||||||0.18|||||||Wilcoxon (Mann-Whitney)|||Month 12: Ease of Communication (Unaided)||||0.18
72440491|NCT01796236|144393815|SUPERIORITY_OR_OTHER|||||||0.76|||||||Wilcoxon (Mann-Whitney)|||Month 12: Background Noise (Unaided)||||0.76
72440492|NCT01796236|144393815|SUPERIORITY_OR_OTHER|||||||0.17|||||||Wilcoxon (Mann-Whitney)|||Month 12: Reverberation (Unaided)||||0.17
72495953|NCT02167945|144521519|SUPERIORITY|||||||0.992||||||The Hazard Ratio for experiencing the event in the group of participants in studies M14-222 and M14-423 who achieved SVR12 compared to those who did not achieve SVR12 is infinite and the CI is not bounded due to zero events in one of the groups.|Cox proportional hazards model|||A Cox proportional hazards (PH) model was constructed. The covariates for the model included baseline age, BMI, HCV genotype 1 subtype (1b, non-1b), IL28B genotype (CC, non-CC), prior treatment history (naive, experienced), baseline HCV RNA levels, baseline fibrosis stage (F0-1, F2, F3, F4), baseline albumin, baseline creatinine clearance, baseline platelet count, history of diabetes (yes, no), APRI, race (white, other), and alcohol use status (current, former, non-drinker).||||0.992
72495954|NCT02167945|144521520|SUPERIORITY||||||<|0.001|||||||Log-rank test|||Comparisons between participants in studies M14-222 and M14-423 who achieved SVR12 and those who did not were performed using a log-rank test.||||<0.001
72495955|NCT02167945|144521520|SUPERIORITY||Cox Proportional Hazard Ratio|0.133|||<|0.001|TWO_SIDED|95.0|0.057|0.313|||Cox proportional hazards model||The estimated value represents the hazard ratio for developing the event in the group of participants in studies M14-222 and M14-423 who achieved SVR12 compared to the group of participants in studies M14-222 and M14-423 who didn't achieve SVR12.|A Cox proportional hazards (PH) model was constructed. The covariates for the model included baseline age, BMI, HCV genotype 1 subtype (1b, non-1b), IL28B genotype (CC, non-CC), prior treatment history (naive, experienced), baseline HCV RNA levels, baseline fibrosis stage (F0-1, F2, F3, F4), baseline albumin, baseline creatinine clearance, baseline platelet count, history of diabetes (yes, no), APRI, race (white, other), and alcohol use status (current, former, non-drinker).||0.313|0.057|<0.001
72495956|NCT02167945|144521522|SUPERIORITY||LS Mean Difference|-1.75|STANDARD_ERROR_OF_MEAN|0.79||0.026|TWO_SIDED|95.0|-3.3|-0.21|||ANCOVA||F2 - F0-F1|"F0-F1 vs F2 at Post-treatment Week 12~The difference between baseline fibrosis stage groups in mean change from baseline was analyzed using ANCOVA with baseline fibrosis stage (F0-F1, F2, F3 and F4) as a factor and baseline patient reported outcomes(PRO) score and SVR12 status as covariates."||-0.21|-3.30|0.026
72495957|NCT02167945|144521522|SUPERIORITY||LS Mean Difference|-0.53|STANDARD_ERROR_OF_MEAN|0.74||0.472|TWO_SIDED|95.0|-1.97|0.91|||ANCOVA||F3 - F0-F1|"F0-F1 vs F3 at Post-treatment Week 12~The difference between baseline fibrosis stage groups in mean change from baseline was analyzed using ANCOVA with baseline fibrosis stage (F0-F1, F2, F3 and F4) as a factor and baseline patient reported outcomes(PRO) score and SVR12 status as covariates."||0.91|-1.97|0.472
72440493|NCT01796236|144393815|SUPERIORITY_OR_OTHER|||||||0.29|||||||Wilcoxon (Mann-Whitney)|||Month 12: Aversiveness (Unaided)||||0.29
72559157|NCT01634139|144648075|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.052|STANDARD_ERROR_OF_MEAN|0.038||0.1666|TWO_SIDED|95.0|-0.022|0.126|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 48||0.126|-0.022|0.1666
72559158|NCT01634139|144648076|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.092|STANDARD_ERROR_OF_MEAN|0.04||0.0228|TWO_SIDED|95.0|0.013|0.171|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 24||0.171|0.013|0.0228
72440494|NCT01796236|144393815|SUPERIORITY_OR_OTHER|||||||0.4|||||||Wilcoxon (Mann-Whitney)|||Month 12: Global (Unaided)||||0.40
72440495|NCT01796236|144393815|SUPERIORITY_OR_OTHER|||||||0.29|||||||Wilcoxon (Mann-Whitney)|||Month 12: Ease of Communication (Benefit)||||0.29
72440496|NCT01796236|144393815|SUPERIORITY_OR_OTHER|||||||0.9|||||||Wilcoxon (Mann-Whitney)|||Month 12: Background Noise (Benefit)||||0.90
72440497|NCT01796236|144393815|SUPERIORITY_OR_OTHER|||||||0.24|||||||Wilcoxon (Mann-Whitney)|||Month 12: Reverberation (Benefit)||||0.24
72440498|NCT01796236|144393815|SUPERIORITY_OR_OTHER|||||||0.45|||||||Wilcoxon (Mann-Whitney)|||Month 12: Aversiveness (Benefit)||||0.45
72440499|NCT01796236|144393815|SUPERIORITY_OR_OTHER|||||||0.37|||||||Wilcoxon (Mann-Whitney)|||Month 12: Global (Benefit)||||0.37
72440500|NCT01796236|144393815|SUPERIORITY_OR_OTHER|||||||0.84|||||||Wilcoxon (Mann-Whitney)|||Month 36: Ease of Communication (Aided)||||0.84
72440501|NCT01796236|144393815|SUPERIORITY_OR_OTHER|||||||0.57|||||||Wilcoxon (Mann-Whitney)|||Month 36: Background Noise (Aided)||||0.57
72440502|NCT01796236|144393815|SUPERIORITY_OR_OTHER|||||||0.71|||||||Wilcoxon (Mann-Whitney)|||Month 36: Reverberation (Aided)||||0.71
72440503|NCT01796236|144393815|SUPERIORITY_OR_OTHER|||||||0.99|||||||Wilcoxon (Mann-Whitney)|||Month 36: Aversiveness (Aided)||||0.99
72440504|NCT01796236|144393815|SUPERIORITY_OR_OTHER|||||||0.78|||||||Wilcoxon (Mann-Whitney)|||Month 36: Global (Aided)||||0.78
72440505|NCT01796236|144393815|SUPERIORITY_OR_OTHER|||||||0.5|||||||Wilcoxon (Mann-Whitney)|||Month 36: Ease of Communication (Unaided)||||0.50
72440506|NCT01796236|144393815|SUPERIORITY_OR_OTHER|||||||0.48|||||||Wilcoxon (Mann-Whitney)|||Month 36: Background Noise (Unaided)||||0.48
72440507|NCT01796236|144393815|SUPERIORITY_OR_OTHER|||||||0.64|||||||Wilcoxon (Mann-Whitney)|||Month 36: Reverberation (Unaided)||||0.64
72440508|NCT01796236|144393815|SUPERIORITY_OR_OTHER|||||||0.041|||||||Wilcoxon (Mann-Whitney)|||Month 36: Aversiveness (Unaided)||||0.041
72440509|NCT01796236|144393815|SUPERIORITY_OR_OTHER|||||||0.89|||||||Wilcoxon (Mann-Whitney)|||Month 36: Global (Unaided)||||0.89
72440510|NCT01796236|144393815|SUPERIORITY_OR_OTHER|||||||0.14|||||||Wilcoxon (Mann-Whitney)|||Month 36: Ease of Communication (Benefit)||||0.14
72440511|NCT01796236|144393815|SUPERIORITY_OR_OTHER|||||||0.48|||||||Wilcoxon (Mann-Whitney)|||Month 36: Background Noise (Benefit)||||0.48
72440512|NCT01796236|144393815|SUPERIORITY_OR_OTHER|||||||0.23|||||||Wilcoxon (Mann-Whitney)|||Month 36: Reverberation (Benefit)||||0.23
72440513|NCT01796236|144393815|SUPERIORITY_OR_OTHER|||||||0.57|||||||Wilcoxon (Mann-Whitney)|||Month 36: Aversiveness (Benefit)||||0.57
72440514|NCT01796236|144393815|SUPERIORITY_OR_OTHER|||||||0.21|||||||Wilcoxon (Mann-Whitney)|||Month 36: Global (Benefit)||||0.21
72440515|NCT01796236|144393816|SUPERIORITY_OR_OTHER|||||||0.46|||||||Wilcoxon (Mann-Whitney)|||Sound Processor Usage: Week 6||||0.46
72440516|NCT01796236|144393816|SUPERIORITY_OR_OTHER|||||||0.75|||||||Wilcoxon (Mann-Whitney)|||Use of Sound Processor: Week 12||||0.75
72440517|NCT01796236|144393816|SUPERIORITY_OR_OTHER|||||||0.83|||||||Wilcoxon (Mann-Whitney)|||Use of Sound Processor: Week 24||||0.83
72440518|NCT01796236|144393816|SUPERIORITY_OR_OTHER|||||||0.52|||||||Wilcoxon (Mann-Whitney)|||Use of Sound Processor: Month 12||||0.52
72440519|NCT01796236|144393816|SUPERIORITY_OR_OTHER|||||||0.67|||||||Wilcoxon (Mann-Whitney)|||Use of Sound Processor: Month 24||||0.67
72440520|NCT01796236|144393816|SUPERIORITY_OR_OTHER|||||||0.71|||||||Wilcoxon (Mann-Whitney)|||Use of Sound Processor: Month 36||||0.71
72440521|NCT01796236|144393818|SUPERIORITY_OR_OTHER|||||||0.91|||||||Mantel Haenszel|||Baseline: Smoking and Wet Snuff habits||||0.91
72440522|NCT01796236|144393818|SUPERIORITY_OR_OTHER|||||||0.7|||||||Mantel Haenszel|||Week 3: Smoking and Wet Snuff habits||||0.70
72440523|NCT01796236|144393818|SUPERIORITY_OR_OTHER|||||||0.95|||||||Mantel Haenszel|||Week 12: Smoking and Wet Snuff habits||||0.95
72440524|NCT01796236|144393818|SUPERIORITY_OR_OTHER|||||||0.22|||||||Mantel Haenszel|||Month 12: Smoking and Wet Snuff habits||||0.22
72440525|NCT01796236|144393818|SUPERIORITY_OR_OTHER|||||||0.19|||||||Mantel Haenszel|||Month 24: Smoking and Wet Snuff habits||||0.19
72440526|NCT01796236|144393818|SUPERIORITY_OR_OTHER|||||||0.45|||||||Mantel Haenszel|||Month 36: Smoking and Wet Snuff habits||||0.45
72440527|NCT01796236|144393819|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.98||||0.989|TWO_SIDED|95.0|||||Log Rank|||Loss of Implant (safety population)||||0.989
72440528|NCT00546754|144393821|SUPERIORITY_OR_OTHER_LEGACY|||||||0.153||95.0|||||ANOVA|||||||0.153
72440529|NCT00546754|144393822|SUPERIORITY_OR_OTHER_LEGACY|||||||0.343||95.0|||||ANOVA|||||||0.343
72440530|NCT00546754|144393823|SUPERIORITY_OR_OTHER_LEGACY|||||||0.118||95.0|||||Fisher Exact|||||||0.118
72440531|NCT00546754|144393824|SUPERIORITY_OR_OTHER_LEGACY|||||||0.395||95.0|||||ANOVA|||||||0.395
72440532|NCT00546754|144393825|SUPERIORITY_OR_OTHER_LEGACY|||||||0.662||95.0|||||Fisher Exact|||||||0.662
72440533|NCT00546754|144393826|SUPERIORITY_OR_OTHER_LEGACY|||||||0.02||95.0|||||Log Rank|||||||0.020
72440534|NCT00546754|144393827|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||ANOVA|||||||<0.001
72440535|NCT00546754|144393828|SUPERIORITY_OR_OTHER_LEGACY|||||||0.935||95.0|||||ANOVA|||||||0.935
72440536|NCT00546754|144393829|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||ANOVA|||||||<0.001
72440537|NCT00546754|144393830|SUPERIORITY_OR_OTHER_LEGACY|||||||0.899||95.0|||||ANOVA|||||||0.899
72440538|NCT00546754|144393831|SUPERIORITY_OR_OTHER_LEGACY|||||||0.218||95.0|||||ANOVA|||||||0.218
72440539|NCT00546754|144393832|SUPERIORITY_OR_OTHER_LEGACY|||||||0.386||95.0|||||ANOVA|||||||0.386
72440540|NCT00546754|144393833|SUPERIORITY_OR_OTHER_LEGACY|||||||0.725||95.0|||||ANOVA|||||||0.725
72440541|NCT00311363|144393841|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.353||||0.0158||95.0|0.2|0.8||Model included terms for treatment group, randomization IRLS score (Week 24), and pooled study site|Regression, Logistic|||||0.8|0.2|0.0158
72440542|NCT03830866|144393874|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.174|TWO_SIDED|95.0|0.65|1.08|||Log Rank|||||1.08|0.65|0.174
72440543|NCT03830866|144393875|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.203|TWO_SIDED|95.0|0.64|1.1|||Log Rank|||||1.10|0.64|0.203
72440544|NCT03830866|144393877|SUPERIORITY||Hazard Ratio (HR)|0.79||||0.091|TWO_SIDED|95.0|0.6|1.04|||Log Rank|||||1.04|0.60|0.091
72440545|NCT03830866|144393878|SUPERIORITY||Odds Ratio (OR)|1.15||||0.465|TWO_SIDED|95.0|0.794|1.657|||Regression, Logistic|||||1.657|0.794|0.465
72440546|NCT03830866|144393879|SUPERIORITY||Odds Ratio (OR)|1.11||||0.469|TWO_SIDED|95.0|0.833|1.487|||Regression, Logistic|||||1.487|0.833|0.469
72440547|NCT05113771|144393899|SUPERIORITY||LS Mean Difference|-4.4||||0.0056|TWO_SIDED|95.0|-7.6|-1.3|||MMRM|mixed model for repeated measures (MMRM) with imputation based on the missing at random (MAR) assumption was used.||||-1.3|-7.6|0.0056
72440548|NCT05113771|144393900|SUPERIORITY|||||||0.0189|||||||MMRM|||||||0.0189
72440549|NCT05113771|144393901|SUPERIORITY|||||||0.0026|||||||Cochran-Mantel-Haenszel|||||||0.0026
72440550|NCT01849055|144393943|SUPERIORITY||Mean Difference (Final Values)|-1.22|||||TWO_SIDED|90.0|-4.98|2.54||||||SBP||2.54|-4.98|
72440551|NCT01849055|144393943|SUPERIORITY||Mean Difference (Final Values)|-1.09|||||TWO_SIDED|90.0|-4.7|2.53||||||SBP||2.53|-4.70|
72440552|NCT01849055|144393943|SUPERIORITY||Mean Difference (Final Values)|-1.54|||||TWO_SIDED|90.0|-5.3|2.22||||||SBP||2.22|-5.30|
72440553|NCT01849055|144393943|SUPERIORITY||Mean Difference (Final Values)|-1.53|||||TWO_SIDED|90.0|-5.16|2.1||||||SBP||2.10|-5.16|
72440554|NCT01849055|144393943|SUPERIORITY||Mean Difference (Final Values)|-3.84|||||TWO_SIDED|90.0|-7.74|0.07||||||SBP||0.07|-7.74|
72440555|NCT01849055|144393943|SUPERIORITY||Mean Difference (Final Values)|-0.38|||||TWO_SIDED|90.0|-2.95|2.18||||||DBP||2.18|-2.95|
72440556|NCT01849055|144393943|SUPERIORITY||Mean Difference (Final Values)|-1.11|||||TWO_SIDED|90.0|-3.69|1.48||||||DBP||1.48|-3.69|
72440557|NCT01849055|144393943|SUPERIORITY||Mean Difference (Final Values)|-0.95|||||TWO_SIDED|90.0|-3.75|1.85||||||DBP||1.85|-3.75|
72440558|NCT01849055|144393943|SUPERIORITY||Mean Difference (Final Values)|-1.49|||||TWO_SIDED|90.0|-4.09|1.1||||||DBP||1.10|-4.09|
72440559|NCT01849055|144393943|SUPERIORITY||Mean Difference (Final Values)|-2.51|||||TWO_SIDED|90.0|-5.23|0.2||||||DBP||0.20|-5.23|
72440560|NCT03122886|144393971|SUPERIORITY||Hazard Ratio (HR)|0.88||||0.9|TWO_SIDED|95.0|0.12|6.37|||Log Rank|||||6.37|0.12|0.90
72440561|NCT03422276|144393972|SUPERIORITY||Mean Difference (Net)|-0.78||||0.44|TWO_SIDED|||||The threshold for statistical significance was p = 0.05|t-test, 2 sided|t-test for independent samples, two-tailed, allocation ratio=1|Intervention mean minus control mean|It was calculated that 500 to 900 participants randomized in a 1:1 fashion between the two arms would have practically 100% power to detect an effect size of 0.5, and even a small sample size of 300 would have 80% power to detect a small effect size of 0.3 (800 to 900 would be 100% power).||||0.44
72440562|NCT03422276|144393973|SUPERIORITY||Mean Difference (Net)|1.63||||0.1|TWO_SIDED||||||t-test, 2 sided|||||||0.10
72440563|NCT05938413|144394037|NON_INFERIORITY|Non-inferiority test to compare viral suppression rate between month 3 and baseline.|Odds Ratio (OR)|3.01|||||TWO_SIDED|||||||||||||
72440564|NCT03312907|144394057|OTHER||Odds Ratio (OR)|1.27||||0.5342|TWO_SIDED|95.0|0.6|2.71|||Regression, Logistic||Odds ratio was calculated using logistic regression model with covariates: Baseline SLEDAI-2K, Baseline immunosuppressant, Baseline prednisone equivalent dose. Belimumab + Standard therapy arm was excluded from model.|||2.71|0.60|0.5342
72559159|NCT01634139|144648076|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.052|STANDARD_ERROR_OF_MEAN|0.04||0.198|TWO_SIDED|95.0|-0.027|0.131|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 24||0.131|-0.027|0.1980
72559160|NCT01634139|144648076|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.062|STANDARD_ERROR_OF_MEAN|0.04||0.1256|TWO_SIDED|95.0|-0.017|0.141|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 48||0.141|-0.017|0.1256
72559161|NCT01634139|144648076|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.053|STANDARD_ERROR_OF_MEAN|0.04||0.188|TWO_SIDED|95.0|-0.026|0.133|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 48||0.133|-0.026|0.1880
72619005|NCT03615534|144768410|OTHER|||||||0.434||||||Results were evaluated in terms of adjusted end line diastolic blood pressure levels, embracing the least significant difference (LSD) for pair-wise comparison. Probability of less than 0.05 was considered statistically significant.|ANCOVA|Covariates appearing in ANCOVA model are evaluated at the following baseline values: diastolic blood pressure= 80.0 mmHg.||Analysis of Covariance (ANCOVA), was applied to assess treatment effects among different arms, comprising the influence of the baseline diastolic blood pressure level as a covariate.||||0.434
72495958|NCT02167945|144521522|SUPERIORITY||LS Mean Difference|-1.03|STANDARD_ERROR_OF_MEAN|0.73||0.159|TWO_SIDED|95.0|-2.47|0.4|||ANCOVA||F4 - F0-F1|"F0-F1 vs F4 at Post-treatment Week 12~The difference between baseline fibrosis stage groups in mean change from baseline was analyzed using ANCOVA with baseline fibrosis stage (F0-F1, F2, F3 and F4) as a factor and baseline patient reported outcomes(PRO) score and SVR12 status as covariates."||0.40|-2.47|0.159
72495959|NCT02167945|144521522|SUPERIORITY||LS Mean Difference|-1.3|STANDARD_ERROR_OF_MEAN|0.84||0.125|TWO_SIDED|95.0|-2.95|0.36|||ANCOVA||F2 - F0-F1|"F0-F1 vs F2 at Post-treatment Week 24~The difference between baseline fibrosis stage groups in mean change from baseline was analyzed using ANCOVA with baseline fibrosis stage (F0-F1, F2, F3 and F4) as a factor and baseline patient reported outcomes(PRO) score and SVR12 status as covariates."||0.36|-2.95|0.125
72495960|NCT02167945|144521522|SUPERIORITY||LS Mean Difference|-0.24|STANDARD_ERROR_OF_MEAN|0.78||0.756|TWO_SIDED|95.0|-1.78|1.29|||ANCOVA||F3 - F0-F1|"F0-F1 vs F3 at Post-treatment Week 24~The difference between baseline fibrosis stage groups in mean change from baseline was analyzed using ANCOVA with baseline fibrosis stage (F0-F1, F2, F3 and F4) as a factor and baseline patient reported outcomes(PRO) score and SVR12 status as covariates."||1.29|-1.78|0.756
72495961|NCT02167945|144521522|SUPERIORITY||LS Mean Difference|-0.79|STANDARD_ERROR_OF_MEAN|0.78||0.315|TWO_SIDED|95.0|-2.32|0.75|||ANCOVA||F4 - F0-F1|"F0-F1 vs F4 at Post-treatment Week 24~The difference between baseline fibrosis stage groups in mean change from baseline was analyzed using ANCOVA with baseline fibrosis stage (F0-F1, F2, F3 and F4) as a factor and baseline patient reported outcomes(PRO) score and SVR12 status as covariates."||0.75|-2.32|0.315
72495962|NCT02167945|144521523|SUPERIORITY||LS Mean Difference|-1.28|STANDARD_ERROR_OF_MEAN|1.03||0.216|TWO_SIDED|95.0|-3.3|0.75|||ANCOVA||F2 - F0-F1|"F0-F1 vs F2 at Post-treatment Week 12~The difference between baseline fibrosis stage groups in mean change from baseline was analyzed using ANCOVA with baseline fibrosis stage (F0-F1, F2, F3 and F4) as a factor and baseline patient reported outcomes(PRO) score and SVR12 status as covariates."||0.75|-3.30|0.216
72495963|NCT02167945|144521523|SUPERIORITY||LS Mean Difference|-1.7|STANDARD_ERROR_OF_MEAN|0.95||0.074|TWO_SIDED|95.0|-3.58|0.17|||ANCOVA||F3 - F0-F1|"F0-F1 vs F3 at Post-treatment Week 12~The difference between baseline fibrosis stage groups in mean change from baseline was analyzed using ANCOVA with baseline fibrosis stage (F0-F1, F2, F3 and F4) as a factor and baseline patient reported outcomes(PRO) score and SVR12 status as covariates."||0.17|-3.58|0.074
72495964|NCT02167945|144521523|SUPERIORITY||LS Mean Difference|-1.81|STANDARD_ERROR_OF_MEAN|0.95||0.056|TWO_SIDED|95.0|-3.67|0.05|||ANCOVA||F4 - F0-F1|"F0-F1 vs F4 at Post-treatment Week 12~The difference between baseline fibrosis stage groups in mean change from baseline was analyzed using ANCOVA with baseline fibrosis stage (F0-F1, F2, F3 and F4) as a factor and baseline patient reported outcomes(PRO) score and SVR12 status as covariates."||0.05|-3.67|0.056
72495965|NCT02167945|144521523|SUPERIORITY||LS Mean Difference|-0.84|STANDARD_ERROR_OF_MEAN|1.02||0.411|TWO_SIDED|95.0|-2.84|1.16|||ANCOVA||F2 - F0-F1|"F0-F1 vs F2 at Post-treatment Week 24~The difference between baseline fibrosis stage groups in mean change from baseline was analyzed using ANCOVA with baseline fibrosis stage (F0-F1, F2, F3 and F4) as a factor and baseline patient reported outcomes(PRO) score and SVR12 status as covariates."||1.16|-2.84|0.411
72495966|NCT02167945|144521523|SUPERIORITY||LS Mean Difference|-1.72|STANDARD_ERROR_OF_MEAN|0.93||0.065|TWO_SIDED|95.0|-3.55|0.11|||ANCOVA||F3 - F0-F1|"F0-F1 vs F3 at Post-treatment Week 24~The difference between baseline fibrosis stage groups in mean change from baseline was analyzed using ANCOVA with baseline fibrosis stage (F0-F1, F2, F3 and F4) as a factor and baseline patient reported outcomes(PRO) score and SVR12 status as covariates."||0.11|-3.55|0.065
72495967|NCT02167945|144521523|SUPERIORITY||LS Mean Difference|-2.08|STANDARD_ERROR_OF_MEAN|0.93||0.026|TWO_SIDED|95.0|-3.91|-0.25|||ANCOVA||F4 - F0-F1|F0-F1 vs F4 at Post-treatment Week 24||-0.25|-3.91|0.026
72559162|NCT01634139|144648077|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.105|STANDARD_ERROR_OF_MEAN|0.034||0.0023|TWO_SIDED|95.0|0.037|0.172|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 24||0.172|0.037|0.0023
72559163|NCT01634139|144648077|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.076|STANDARD_ERROR_OF_MEAN|0.034||0.0255|TWO_SIDED|95.0|0.009|0.143|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 24||0.143|0.009|0.0255
72559164|NCT01634139|144648078|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.092|STANDARD_ERROR_OF_MEAN|0.04||0.0228|TWO_SIDED|95.0|0.013|0.171|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|10 minutes pre-dose (Week 24)||0.171|0.013|0.0228
72559165|NCT01634139|144648078|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.052|STANDARD_ERROR_OF_MEAN|0.04||0.198|TWO_SIDED|95.0|-0.027|0.131|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|10 minutes pre-dose.(Week 24)||0.131|-0.027|0.1980
72559166|NCT01634139|144648078|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.078|STANDARD_ERROR_OF_MEAN|0.037||0.0344|TWO_SIDED|95.0|0.006|0.15|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|30 minutes post-dose (Week 24)||0.150|0.006|0.0344
72440565|NCT03312907|144394057|OTHER||Odds Ratio (OR)|0.71|||||TWO_SIDED|95.0|0.32|1.54|||||Odds ratio was calculated using logistic regression model with covariates: Baseline SLEDAI-2K, Baseline immunosuppressant, and Baseline prednisone equivalent dose. Belimumab + Placebo arm excluded from model.|||1.54|0.32|
72440566|NCT03312907|144394058|OTHER||Odds Ratio (OR)|1.12||||0.8582|TWO_SIDED|95.0|0.33|3.78|||Regression, Logistic||Odds ratio was calculated using logistic regression model with covariates: Baseline SLEDAI-2K, Baseline immunosuppressant, Baseline prednisone equivalent dose and treatment group. Belimumab + Standard therapy arm was excluded from model.|||3.78|0.33|0.8582
72440567|NCT03312907|144394058|OTHER||Odds Ratio (OR)|0.53|||||TWO_SIDED|95.0|0.17|1.7|||||Odds ratio was calculated using logistic regression model with covariates: Baseline SLEDAI-2K, Baseline immunosuppressant, Baseline prednisone equivalent dose and treatment group. Belimumab + Placebo arm was excluded from model.|||1.70|0.17|
72440568|NCT03312907|144394059|OTHER||Odds Ratio (OR)|1.64||||0.3613|TWO_SIDED|95.0|0.57|4.72|||Regression, Logistic||Odds ratio was calculated using logistic regression model with covariates: Baseline SLEDAI-2K, Baseline immunosuppressant, Baseline prednisone equivalent dose and treatment group. Belimumab + Standard therapy arm was excluded from model.|||4.72|0.57|0.3613
72440569|NCT03312907|144394059|OTHER||Odds Ratio (OR)|0.45|||||TWO_SIDED|95.0|0.19|1.09|||||Odds ratio was calculated using logistic regression model with covariates: Baseline SLEDAI-2K, Baseline immunosuppressant, Baseline prednisone equivalent dose and treatment group. Belimumab + Placebo arm excluded from model.|||1.09|0.19|
72440570|NCT03312907|144394065|OTHER||Hazard Ratio (HR)|0.81||||0.215|TWO_SIDED|95.0|0.57|1.13|||Cox proportional hazards model||Hazard ratio was calculated using Cox proportional hazards model with covariates: Baseline SLEDAI-2K, Baseline immunosuppressant, Baseline prednisone equivalent dose and treatment group. Belimumab + Standard therapy arm was excluded from model.|||1.13|0.57|0.2150
72440571|NCT03312907|144394065|OTHER||Hazard Ratio (HR)|1.64|||||TWO_SIDED|95.0|1.03|2.63|||||Hazard ratio was calculated using Cox proportional hazards model with covariates: Baseline SLEDAI-2K, Baseline immunosuppressant, Baseline prednisone equivalent dose and treatment group. Belimumab + Placebo arm excluded from model.|||2.63|1.03|
72440572|NCT03312907|144394066|OTHER||Hazard Ratio (HR)|0.87||||0.3757|TWO_SIDED|95.0|0.64|1.19|||Cox proportional hazards model||Hazard ratio was calculated using Cox proportional hazards model with covariates: Baseline SLEDAI-2K, Baseline immunosuppressant, Baseline prednisone equivalent dose and treatment group. Belimumab + Standard therapy arm was excluded from model.|||1.19|0.64|0.3757
72440573|NCT03312907|144394066|OTHER||Hazard Ratio (HR)|1.03|||||TWO_SIDED|95.0|0.71|1.49|||||Hazard ratio was calculated using Cox proportional hazards model with covariates: Baseline SLEDAI-2K, Baseline immunosuppressant, Baseline prednisone equivalent dose and treatment group. Belimumab + Placebo arm excluded from model.|||1.49|0.71|
72440574|NCT03312907|144394067|OTHER||Hazard Ratio (HR)|1.55||||0.5127|TWO_SIDED|95.0|0.42|5.78|||Cox proportional hazards model||Hazard ratio was calculated using Cox proportional hazards model with covariates: Baseline SLEDAI-2K, Baseline immunosuppressant, Baseline prednisone equivalent dose and treatment group. Belimumab + Standard therapy arm was excluded from model.|||5.78|0.42|0.5127
72440575|NCT03312907|144394067|OTHER||Hazard Ratio (HR)|0.7|||||TWO_SIDED|95.0|0.23|2.1|||||Hazard ratio was calculated using Cox proportional hazards model with covariates: Baseline SLEDAI-2K, Baseline immunosuppressant, Baseline prednisone equivalent dose and treatment group. Belimumab + Placebo arm excluded from model.|||2.10|0.23|
72440576|NCT03312907|144394068|OTHER||Hazard Ratio (HR)|0.83||||0.8436|TWO_SIDED|95.0|0.14|5.05|||Cox proportional hazards model||Hazard ratio was calculated using Cox proportional hazards model with covariates: Baseline SLEDAI-2K, Baseline prednisone equivalent dose and treatment group. Belimumab + Standard therapy arm was excluded from model.|||5.05|0.14|0.8436
72440577|NCT03312907|144394068|OTHER||Hazard Ratio (HR)|0.52|||||TWO_SIDED|95.0|0.09|3.14|||||Hazard ratio was calculated using Cox proportional hazards model with covariates: Baseline SLEDAI-2K, Baseline prednisone equivalent dose and treatment group. Belimumab + Placebo arm excluded from model.|||3.14|0.09|
72440578|NCT03312907|144394075|OTHER||Odds Ratio (OR)|1.55||||0.7102|TWO_SIDED|95.0|0.15|15.7|||Regression, Logistic|Week 52|Odds ratio at Week 52 was calculated using Logistic regression model with covariates:Baseline SLEDAI-2K,Baseline immunosuppressant,Baseline prednisone equivalent dose and treatment group. Belimumab+ Standard therapy arm was excluded from the model.|||15.70|0.15|0.7102
72440579|NCT03312907|144394075|OTHER||Odds Ratio (OR)|1.06|||||TWO_SIDED|95.0|0.1|10.71|||||Odds ratio at Week 52 was calculated using Logistic regression model with covariates:Baseline SLEDAI-2K,Baseline immunosuppressant, Baseline prednisone equivalent dose and treatment group. Belimumab + Placebo arm was excluded from the model.|||10.71|0.10|
72440580|NCT03312907|144394075|OTHER||Odds Ratio (OR)|0.9||||0.8641|TWO_SIDED|95.0|0.26|3.15|||Regression, Logistic|Week 104|Odds ratio at Week 104 was calculated using Logistic regression model with covariates:Baseline SLEDAI-2K,Baseline immunosuppressant,Baseline prednisone equivalent dose and treatment group. Belimumab + Standard therapy arm was excluded from the model.|||3.15|0.26|0.8641
72440581|NCT03312907|144394075|OTHER||Odds Ratio (OR)|1.22|||||TWO_SIDED|95.0|0.26|5.64|||||Odds ratio at Week 104 was calculated using Logistic regression model with covariates:Baseline SLEDAI-2K,Baseline immunosuppressant,Baseline prednisone equivalent dose and treatment group. Belimumab + Placebo arm was excluded from the model.|||5.64|0.26|
72440582|NCT02576574|144394085|SUPERIORITY||Hazard Ratio (HR)|0.71||||0.007|TWO_SIDED|95.0|0.54|0.93|||Log Rank|||||0.93|0.54|0.0070
72440583|NCT02576574|144394086|SUPERIORITY||Hazard Ratio (HR)|0.72||||0.0196|TWO_SIDED|95.0|0.52|0.98|||Log Rank|||||0.98|0.52|0.0196
72440584|NCT02576574|144394087|SUPERIORITY||Hazard Ratio (HR)|0.85||||0.1032|TWO_SIDED|95.0|0.67|1.09|||Log Rank|||||1.09|0.67|0.1032
72440585|NCT02576574|144394088|SUPERIORITY||Hazard Ratio (HR)|0.79||||0.063|TWO_SIDED|95.0|0.59|1.07|||Log Rank|||||1.07|0.59|0.0630
72440586|NCT02576574|144394089|SUPERIORITY||Hazard Ratio (HR)|0.78||||0.0147|TWO_SIDED|95.0|0.62|0.98|||Log Rank|||||0.98|0.62|0.0147
72440587|NCT02576574|144394090|SUPERIORITY||Hazard Ratio (HR)|0.88||||0.1753|TWO_SIDED|95.0|0.67|1.15|||Log Rank|||||1.15|0.67|0.1753
72440588|NCT02576574|144394091|SUPERIORITY||Hazard Ratio (HR)|0.82||||0.0257|TWO_SIDED|95.0|0.66|1.0|||Log Rank|||||1.00|0.66|0.0257
72440589|NCT02576574|144394092|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.0809|TWO_SIDED|95.0|0.66|1.07|||Log Rank|||||1.07|0.66|0.0809
72440590|NCT02576574|144394093|SUPERIORITY||Hazard Ratio (HR)|0.92||||0.1294|TWO_SIDED|95.0|0.78|1.07|||Log Rank|||||1.07|0.78|0.1294
72440591|NCT02576574|144394094|SUPERIORITY||Hazard Ratio (HR)|0.94||||0.2618|TWO_SIDED|95.0|0.79|1.13|||Log Rank|||||1.13|0.79|0.2618
72495968|NCT02167945|144521524|SUPERIORITY||LS Mean Difference|-2.0|STANDARD_ERROR_OF_MEAN|0.95||0.035|TWO_SIDED|95.0|-3.86|-0.14|||ANCOVA||F2 - F0-F1|"F0-F1 vs F2 at Post-treatment Week 12~The difference between baseline fibrosis stage groups in mean change from baseline was analyzed using ANCOVA with baseline fibrosis stage (F0-F1, F2, F3 and F4) as a factor and baseline patient reported outcomes (PRO) score and SVR12 status as covariates."||-0.14|-3.86|0.035
72440592|NCT02576574|144394095|SUPERIORITY||Odds Ratio (OR)|1.41||||0.064|TWO_SIDED|95.0|0.91|2.18|||Cochran-Mantel-Haenszel|||||2.18|0.91|0.0640
72440593|NCT02576574|144394096|SUPERIORITY||Odds Ratio (OR)|1.23||||0.2217|TWO_SIDED|95.0|0.73|2.07|||Cochran-Mantel-Haenszel|||||2.07|0.73|0.2217
72440594|NCT02576574|144394097|SUPERIORITY||Odds Ratio (OR)|1.18||||0.1912|TWO_SIDED|95.0|0.81|1.72|||Cochran-Mantel-Haenszel|||||1.72|0.81|0.1912
72440595|NCT02576574|144394098|SUPERIORITY||Odds Ratio (OR)|1.0||||0.4951|TWO_SIDED|95.0|0.64|1.57|||Cochran-Mantel-Haenszel|||||1.57|0.64|0.4951
72440596|NCT04723394|144394123|SUPERIORITY||Relative Risk Reduction (100*[1-RR])|50.38||||0.01|TWO_SIDED|95.0|14.38|71.25|||Cochran-Mantel-Haenszel|CMH was stratified by randomization factors||AZD7442 vs Placebo||71.25|14.38|0.010
72440597|NCT04723394|144394124|SUPERIORITY||Relative Risk Reduction (100*[1-RR])|49.24||||0.009|TWO_SIDED|95.0|14.72|69.79|||Cochran-Mantel-Haenszel|CMH was stratified by randomization factors||AZD7442 vs Placebo||69.79|14.72|0.009
72495969|NCT02167945|144521524|SUPERIORITY||LS Mean Difference|-2.15|STANDARD_ERROR_OF_MEAN|0.88||0.015|TWO_SIDED|95.0|-3.88|-0.42|||ANCOVA||F3 - F0-F1|"F0-F1 vs F3 at Post-treatment Week 12~The difference between baseline fibrosis stage groups in mean change from baseline was analyzed using ANCOVA with baseline fibrosis stage (F0-F1, F2, F3 and F4) as a factor and baseline patient reported outcomes(PRO) score and SVR12 status as covariates."||-0.42|-3.88|0.015
72495970|NCT02167945|144521524|SUPERIORITY||LS Mean Difference|-1.74|STANDARD_ERROR_OF_MEAN|0.88||0.048|TWO_SIDED|95.0|-3.46|-0.01|||ANCOVA||F4 - F0-F1|F0-F1 vs F4 at Post-treatment Week 12||-0.01|-3.46|0.048
72495971|NCT02167945|144521524|SUPERIORITY||LS Mean Difference|-0.72|STANDARD_ERROR_OF_MEAN|0.99||0.466|TWO_SIDED|95.0|-2.67|1.22|||ANCOVA||F2 - F0-F1|"F0-F1 vs F2 at Post-treatment Week 24~The difference between baseline fibrosis stage groups in mean change from baseline was analyzed using ANCOVA with baseline fibrosis stage (F0-F1, F2, F3 and F4) as a factor and baseline patient reported outcomes(PRO) score and SVR12 status as covariates."||1.22|-2.67|0.466
72495972|NCT02167945|144521524|SUPERIORITY||LS Mean Difference|-1.91|STANDARD_ERROR_OF_MEAN|0.91||0.035|TWO_SIDED|95.0|-3.7|-0.13|||ANCOVA||F3 - F0-F1|"F0-F1 vs F3 at Post-treatment Week 24~The difference between baseline fibrosis stage groups in mean change from baseline was analyzed using ANCOVA with baseline fibrosis stage (F0-F1, F2, F3 and F4) as a factor and baseline patient reported outcomes(PRO) score and SVR12 status as covariates."||-0.13|-3.70|0.035
72495973|NCT02167945|144521524|SUPERIORITY||LS Mean Difference|-2.22|STANDARD_ERROR_OF_MEAN|0.91||0.015|TWO_SIDED|95.0|-4.01|-0.43|||ANCOVA||F4 - F0-F1|"F0-F1 vs F4 at Post-treatment Week 24~The difference between baseline fibrosis stage groups in mean change from baseline was analyzed using ANCOVA with baseline fibrosis stage (F0-F1, F2, F3 and F4) as a factor and baseline patient reported outcomes(PRO) score and SVR12 status as covariates."||-0.43|-4.01|0.015
72495974|NCT02623335|144521555|SUPERIORITY||Odds Ratio (OR)|1.32||||0.353|TWO_SIDED||||||Mixed Models Analysis|||Options questions||||0.353
72495975|NCT02623335|144521555|SUPERIORITY||Odds Ratio (OR)|0.97||||0.923|TWO_SIDED||||||Mixed Models Analysis|||Expectations questions||||0.923
72495976|NCT02623335|144521555|SUPERIORITY||Odds Ratio (OR)|1.41||||0.255|TWO_SIDED||||||Mixed Models Analysis|||Risks questions||||0.255
72440598|NCT00774397|144394126|SUPERIORITY_OR_OTHER|||||||0.0537||95.0||||P-value based on Fisher's exact test (2-sided)|Fisher Exact|||||||0.0537
72440599|NCT00774397|144394126|SUPERIORITY_OR_OTHER|||||||0.0213||||||P-value based on Fisher's exact test (2-sided)|Fisher Exact|||||||0.0213
72440600|NCT00774397|144394126|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value based on Fisher's exact test (2-sided)|Fisher Exact|||||||<0.0001
72440601|NCT00774397|144394126|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value based on Fisher's exact test (2-sided)|Fisher Exact|||||||<0.0001
72440602|NCT00774397|144394126|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value based on Fisher's exact test (2-sided)|Fisher Exact|||||||<0.0001
72440603|NCT00774397|144394126|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value based on Fisher's exact test (2-sided)|Fisher Exact|||||||<0.0001
72440604|NCT00253890|144394167|SUPERIORITY_OR_OTHER||Mean Difference (Net)|35.7||||0.05||95.0|||||t-test, 2 sided|||Change in sleep quality was assessed by calculating gain scores. We used a 2-sided t-test to report mean change.||||.05
72440605|NCT00077675|144394168|NON_INFERIORITY_OR_EQUIVALENCE|Sample size was selected on the basis of clinical judgment and was deemed adequate to provide clinically meaningful descriptive results consistent with study objectives. This sample size was estimated to provide 91% power to test telavancin's non-inferiority to vancomycin with respect to clinical response using a non-inferiority margin of 20%||||||0.5318|||||||2-sided 95% confidence interval calculat|||95% Confidence Interval: -0.0527 to 0.1102 No estimated value Parameter that was estimated: Risk Difference||||0.5318
72440606|NCT02765100|144394170|EQUIVALENCE|Unless specified otherwise, each of the statistical tests above will use a two-tailed alpha-level of 0.05.|Mean Difference (Final Values)|-0.2|STANDARD_DEVIATION|3.4|<|0.05|TWO_SIDED||||||t-test, 2 sided|||This is a pilot proof of concept study and does not require formal sample size calculations. High and low CRP groups will be compared on demographic, clinical and biological variables using two-sample t-tests or analysis of variance (ANOVA) tests for continuous variables (for nonparametric continuous variables, either Mann-Whitney tests or Kruskal-Wallis tests will be used) and chi-square tests or Fisher's exact tests for categorical variables.||||<0.05
72440607|NCT02652442|144394194|SUPERIORITY|||||||0.97|||||||t-test, 2 sided|Paired samples t-test for change in SVV (measured in degrees)||Null hypothesis: The change in SVV (Post-OAR - Pre-OAR) will not be different for the off-axis distance of 3.5 cm and 7.0 cm.||||0.97
72440608|NCT02652442|144394194|SUPERIORITY|||||||0.51|||||||t-test, 2 sided|Paired samples t-test for change in SVV (measured in degrees)||Null hypothesis: The change in SVV (Post-OAR - Pre-OAR) will not be different for the centrifugation duration of 1 minute and 3 minutes.||||0.51
72495977|NCT02623335|144521555|SUPERIORITY||Odds Ratio (OR)|239047259.0||||0.094|TWO_SIDED||||||Mixed Models Analysis|||Advance directives questions||||0.094
72495978|NCT02623335|144521556|SUPERIORITY||Effect estimate|-0.04||||0.84|TWO_SIDED||||||Mixed Models Analysis|||Change in scores between T2 and T1||||0.84
72495979|NCT02623335|144521556|SUPERIORITY||Effect estimate|-0.15||||0.645|TWO_SIDED||||||Mixed Models Analysis|||Change in scores between T3 and T1||||0.645
72440609|NCT02652442|144394194|SUPERIORITY|||||||0.44|||||||t-test, 2 sided|Paired samples t-test for change in SVV (measured in degrees)||Null hypothesis: The change in SVV (Post-OAR - Pre-OAR) will not be different for the centrifugation schedule of daily OAR and biweekly OAR for a total of 5 sessions.||||0.44
72440610|NCT02253537|144394244|EQUIVALENCE|2 x 2 contingency table with 95% CI.|2 x 2 contingency table|86.7|||||TWO_SIDED|95.0|62.1|96.3||||||||96.3|62.1|
72440611|NCT04470375|144394248|OTHER|Paired samples pre-post t-test||||||0.137|||||||t-test, 2 sided|||||||.137
72440612|NCT04470375|144394249|OTHER|Paired samples t-test (pre - post measure of group)||||||0.01|||||||t-test, 2 sided|||||||.010
72440613|NCT04470375|144394250|OTHER|Paired samples t-test (pre post measure of group)||||||0.591|||||||t-test, 2 sided|||||||.591
72440614|NCT03337399|144394256|NON_INFERIORITY|Non-inferiority of stepped PC was established if the lower one-sided 95% confidence limit for the estimated difference in means was greater than the pre-specified margin of -4.5 points, which corresponds to the one-sided 5% significance level test against this margin.|Mean Difference (Final Values)|2.9|||<|0.05|ONE_SIDED|95.0|-0.01||||Regression, Linear|||The difference in week 24 means between groups was estimated using a linear regression model adjusted for baseline FACT-L score.|||-.01|<0.05
72440615|NCT03337399|144394257|NON_INFERIORITY|Pre-specified margin of -10%.|Estimated Proportions|-2.6|||<|0.15|ONE_SIDED|95.0|-10.4|||We used a false discovery rate (FDR) control approach to interpret the results of significance tests of the three secondary outcomes with an FDR of 0.15.|Regression, Linear|||Non-inferiority of stepped PC in the proportion reporting patient-clinician communication about end-of-life care at each patient's final follow-up assessment was evaluated using a binomial generalized linear model with identity link and a one-sided test against the pre-specified margin of -10%.|||-10.4|<0.15
72440616|NCT03337399|144394258|NON_INFERIORITY|Pre-specified margin of -7 days|Median Difference (Final Values)|-15.2||||0.15|ONE_SIDED|95.0|-25.1|||We used a false discovery rate (FDR) control approach to interpret the results of significance tests of the three secondary outcomes with an FDR of 0.15.|Regression, Linear|||Among patients who died, non-inferiority of stepped PC in the mean length of stay in hospice was assessed using linear regression and a one-sided test against the pre-specified margin of -7 days, based upon published quality metrics.|||-25.1|0.15
72440617|NCT03337399|144394259|SUPERIORITY||Median Difference (Final Values)|-2.3||||0.15|TWO_SIDED|95.0|-2.7|-1.8||We used a false discovery rate (FDR) control approach to interpret the results of significance tests of the three secondary outcomes with an FDR of 0.15|Regression, Linear|||The difference between groups in the mean number of outpatient PC visits per patient by week 24 was assessed using linear regression and a two-sided superiority test.||-1.8|-2.7|0.15
72440618|NCT02214550|144394279|SUPERIORITY||Slope|-1.96|STANDARD_ERROR_OF_MEAN|0.69||0.02|TWO_SIDED|||||The a priori threshold for statistical significance was .05 and p-values were not adjusted for multiple comparisons given a priori orthogonal contrasts.|Mixed Models Analysis||Parameter reported indicates time x group interaction (OCP vs. No OCP). PBS participants are included in the OCP group|A linear mixed-effects model was estimated predicting bladder pain at first urge ratings (0-100 visual analog scale) as a function of time (0, 6, 12 month visits), group, and their interaction. Random intercepts were estimated for each participant. The following three orthogonal contrasts were estimated: 1) OCP vs. No OCP, 2) cyclic vs. continuous microgestin, and 3) PBS-continuous microgestin vs. D+COS-continuous microgestin.||||.02
72440619|NCT02214550|144394279|SUPERIORITY||Slope|-1.4597|STANDARD_ERROR_OF_MEAN|0.8245||0.08|TWO_SIDED|||||The a priori threshold for statistical significance was .05 and p-values were not adjusted for multiple comparisons given a priori orthogonal contrasts.|Mixed Models Analysis||Parameter estimated indicates the time x group (Continuous vs. Cyclic OCP) interaction. PBS participants are included in the continuous OCP group.|A linear mixed-effects model was estimated predicting bladder pain at first urge ratings (0-100 visual analog scale) as a function of time (0, 6, 12 month visits), group, and their interaction. Random intercepts were estimated for each participant. The following three orthogonal contrasts were estimated: 1) OCP vs. No OCP, 2) cyclic vs. continuous microgestin, and 3) PBS-continuous microgestin vs. D+COS-continuous microgestin.||||.08
72440620|NCT02214550|144394279|SUPERIORITY||Slope|1.9186|STANDARD_ERROR_OF_MEAN|0.8121||0.023|TWO_SIDED|||||The a priori threshold for statistical significance was .05 and p-values were not adjusted for multiple comparisons given a priori orthogonal contrasts.|Mixed Models Analysis||Parameter reported indicates a time x group interaction (D+COS-continuous microgestin vs. PBS-continuous microgestin).|A linear mixed-effects model was estimated predicting bladder pain at first urge ratings (0-100 visual analog scale) as a function of time (0, 6, 12 month visits), group, and their interaction. Random intercepts were estimated for each participant. The following three orthogonal contrasts were estimated: 1) OCP vs. No OCP, 2) cyclic vs. continuous microgestin, and 3) PBS-continuous microgestin vs. D+COS-continuous microgestin.||||.023
72440621|NCT02214550|144394280|SUPERIORITY||Slope|0.3716|STANDARD_ERROR_OF_MEAN|0.3056||0.2315|TWO_SIDED|||||The a priori threshold for statistical significance was .05 and p-values were not adjusted for multiple comparisons given a priori orthogonal contrasts.|Mixed Models Analysis||Parameter reported indicates time\*group interaction (OCP vs. No OCP). PBS participants are included in the OCP group|A linear mixed-effects model was estimated predicting pressure pain thresholds (in Newtons of force transvaginally measured anteriorly against the bladder) as a function of time (0, 6, 12 month visits), group, and their interaction. Random intercepts were estimated for each participant. The following three orthogonal contrasts were estimated: 1) OCP vs. No OCP, 2) cyclic vs. continuous microgestin, and 3) PBS-continuous microgestin vs. D+COS-continuous microgestin.||||0.2315
72495980|NCT02623335|144521557|SUPERIORITY||Effect estimate|-0.37||||0.411|TWO_SIDED||||||Mixed Models Analysis|||||||0.411
72495981|NCT02623335|144521558|SUPERIORITY||Odds Ratio (OR)|1.39||||0.412|TWO_SIDED||||||Mixed Models Analysis|||||||0.412
72495982|NCT02623335|144521559|SUPERIORITY||Effect estimate|-0.25||||0.009|TWO_SIDED||||||Mixed Models Analysis|||||||0.009
72495983|NCT02623335|144521560|SUPERIORITY||Effect estimate|-0.72||||0.106|TWO_SIDED||||||Mixed Models Analysis|||6-8 weeks post-enrollment (T2)||||0.106
72495984|NCT02623335|144521560|SUPERIORITY||Effect estimate|-1.12||||0.007|TWO_SIDED||||||Mixed Models Analysis|||3-4 months post-enrollment post-enrollment (T3)||||0.007
72495985|NCT02623335|144521561|SUPERIORITY||Effect estimate|0.97||||0.034|TWO_SIDED||||||Mixed Models Analysis|||6-8 weeks post-enrollment (T2)||||0.034
72495986|NCT02623335|144521561|SUPERIORITY||Effect estimate|1.12||||0.019|TWO_SIDED||||||Mixed Models Analysis|||3-4 months post-enrollment (T3)||||0.019
72440622|NCT02214550|144394280|SUPERIORITY||Slope|0.2703|STANDARD_ERROR_OF_MEAN|0.3244||0.4097|TWO_SIDED|||||The a priori threshold for statistical significance was .05 and p-values were not adjusted for multiple comparisons given a priori orthogonal contrasts.|Mixed Models Analysis||Parameter estimated indicates the time x group (Continuous vs. Cyclic OCP) interaction. PBS participants are included in the continuous OCP group.|A linear mixed-effects model was estimated predicting pressure pain thresholds (in Newtons of force transvaginally measured anteriorly against the bladder) as a function of time (0, 6, 12 month visits), group, and their interaction. Random intercepts were estimated for each participant. The following three orthogonal contrasts were estimated: 1) OCP vs. No OCP, 2) cyclic vs. continuous microgestin, and 3) PBS-continuous microgestin vs. D+COS-continuous microgestin.||||0.4097
72440623|NCT02214550|144394280|SUPERIORITY||Slope|-0.1574|STANDARD_ERROR_OF_MEAN|0.3283||0.6341|TWO_SIDED|||||The a priori threshold for statistical significance was .05 and p-values were not adjusted for multiple comparisons given a priori orthogonal contrasts.|Mixed Models Analysis||Parameter estimated indicates the time x group (continuous microgestin: D+COS-vs. PBS) interaction.|A linear mixed-effects model was estimated predicting pressure pain thresholds (in Newtons of force transvaginally measured anteriorly against the bladder) as a function of time (0, 6, 12 month visits), group, and their interaction. Random intercepts were estimated for each participant. The following three orthogonal contrasts were estimated: 1) OCP vs. No OCP, 2) cyclic vs. continuous microgestin, and 3) PBS-continuous microgestin vs. D+COS-continuous microgestin.||||0.6341
72495987|NCT02623335|144521562|SUPERIORITY||Effect estimate|1.16||||0.022|TWO_SIDED||||||Mixed Models Analysis|||6-8 weeks post-enrollment (T2)||||0.022
72387518|NCT02609828|144283481|SUPERIORITY||Difference in LS mean|-0.5|STANDARD_ERROR_OF_MEAN|0.66||0.4496|TWO_SIDED|95.0|-1.83|0.83|||ANCOVA|||Change at Week 12: ANCOVA model for imputed datasets included treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and baseline average pain intensity at the index bone metastasis cancer pain site and baseline opioid dose as covariates.||0.83|-1.83|0.4496
72495988|NCT02623335|144521562|SUPERIORITY||Effect estimate|0.94||||0.053|TWO_SIDED||||||Mixed Models Analysis|||3-4 months post-enrollment post-enrollment (T3)||||0.053
72387519|NCT02609828|144283481|SUPERIORITY||Difference in least square LS mean|-1.21|STANDARD_ERROR_OF_MEAN|0.77||0.1263|TWO_SIDED|95.0|-2.77|0.36|||ANCOVA|||Change at Week 16: ANCOVA model for imputed datasets included treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and baseline average pain intensity at the index bone metastasis cancer pain site and baseline opioid dose as covariates.||0.36|-2.77|0.1263
72387520|NCT02609828|144283481|SUPERIORITY||Difference in LS mean|-1.05|STANDARD_ERROR_OF_MEAN|0.73||0.162|TWO_SIDED|95.0|-2.54|0.44|||ANCOVA|||Change at Week 24: ANCOVA model for imputed datasets included treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and baseline average pain intensity at the index bone metastasis cancer pain site and baseline opioid dose as covariates.||0.44|-2.54|0.1620
72387521|NCT02609828|144283482|SUPERIORITY||Difference in LS mean|-1.07|STANDARD_ERROR_OF_MEAN|0.54||0.0575|TWO_SIDED|95.0|-2.17|0.04|||ANCOVA|||Change at Week 1: ANCOVA model for imputed datasets included treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the non-index cancer pain sites and baseline opioid dose as covariates.||0.04|-2.17|0.0575
72387522|NCT02609828|144283482|SUPERIORITY||Difference in LS mean|-1.96|STANDARD_ERROR_OF_MEAN|0.62||0.0031|TWO_SIDED|95.0|-3.22|-0.7|||ANCOVA|||Change at Week 2: ANCOVA model for imputed datasets included treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the non-index cancer pain sites and baseline opioid dose as covariates.||-0.70|-3.22|0.0031
72495989|NCT02623335|144521564|SUPERIORITY||Effect estimate|5.04||||0.07|TWO_SIDED||||||Mixed Models Analysis|||||||0.07
72495990|NCT01046695|144521578|SUPERIORITY_OR_OTHER|||||||0.005||95.0|||||t-test, 2 sided|||Decrease in OME use in the TENS Unit during the first and second 24 hours.||||.005
72495991|NCT01046695|144521578|SUPERIORITY_OR_OTHER|||||||0.11||95.0|||||t-test, 2 sided|||Decrease in OME use in the Control Arm during the first and second 24 hours.||||.11
72495992|NCT01046695|144521579|SUPERIORITY_OR_OTHER|||||||0.7||95.0|||||t-test, 2 sided|||||||.70
72495993|NCT03072160|144521583|OTHER|||||||0.926||||||CD4|Wilcoxon signed-rank test||||A change is defined as being statistically significant (p\>0.05).|||0.926
72495994|NCT03072160|144521583|OTHER|||||||0.445||||||CD8|Wilcoxon signed-rank test||||A change is defined as being statistically significant (p\>0.05).|||0.445
72387523|NCT02609828|144283482|SUPERIORITY||Difference in LS mean|-1.44|STANDARD_ERROR_OF_MEAN|0.68||0.041|TWO_SIDED|95.0|-2.82|-0.06|||ANCOVA|||Change at Week 4: ANCOVA model for imputed datasets included treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the non-index cancer pain sites and baseline opioid dose as covariates.||-0.06|-2.82|0.0410
72387524|NCT02609828|144283482|SUPERIORITY||Difference in LS mean|-0.88|STANDARD_ERROR_OF_MEAN|0.77||0.2598|TWO_SIDED|95.0|-2.44|0.68|||ANCOVA|||Change at Week 6: ANCOVA model for imputed datasets included treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the non-index cancer pain sites and baseline opioid dose as covariates.||0.68|-2.44|0.2598
72387525|NCT02609828|144283482|SUPERIORITY||Difference in LS mean|-0.77|STANDARD_ERROR_OF_MEAN|0.8||0.3426|TWO_SIDED|95.0|-2.38|0.85|||ANCOVA|||Change at Week 8: ANCOVA model for imputed datasets included treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the non-index cancer pain sites and baseline opioid dose as covariates.||0.85|-2.38|0.3426
72440624|NCT02214550|144394281|SUPERIORITY||Slope|0.086|STANDARD_ERROR_OF_MEAN|0.1||0.393|TWO_SIDED|||||The a priori threshold for statistical significance was .05 and p-values were not adjusted for multiple comparisons given a priori orthogonal contrasts.|Mixed Models Analysis||Parameter reported indicates time x group interaction (OCP vs. No OCP). PBS participants are included in the OCP group.|A linear mixed-effects model was estimated for parieto-occipital peak alpha (Hz) as a function of time (0, 6, 12 month visits), group, and their interaction. Random intercepts were estimated for each participant. The OCP vs No OCP contrast was estimated here:||||.393
72440625|NCT02214550|144394281|SUPERIORITY||Slope|0.007|STANDARD_ERROR_OF_MEAN|0.09||0.941|TWO_SIDED|||||The a priori threshold for statistical significance was .05 and p-values were not adjusted for multiple comparisons given a priori orthogonal contrasts.|Mixed Models Analysis||Parameters reported indicates time x group (Continuous vs. Cyclic OCP) interaction. PBS participants are included in the continuous OCP group.|A linear mixed-effects model was estimated for parieto-occipital peak alpha (Hz) as a function of time (0, 6, 12 month visits), group, and their interaction. Random intercepts were estimated for each participant. The cyclic vs. continuous microgestin contrast was run here||||0.941
72440626|NCT02214550|144394281|SUPERIORITY||Slope|0.28|STANDARD_ERROR_OF_MEAN|0.1||0.005|TWO_SIDED|||||The a priori threshold for statistical significance was .05 and p-values were not adjusted for multiple comparisons given a priori orthogonal contrasts.|Mixed Models Analysis||Parameter reported indicates time x group interaction (D+COS-continuous microgestin vs. PBS-continuous microgestin).|A linear mixed-effects model was estimated for parieto-occipital peak alpha (Hz) as a function of time (0, 6, 12 month visits), group, and their interaction. Random intercepts were estimated for each participant. The PBS-continuous microgestin vs. D+COS-continuous microgestin contrast was evaluated here||||0.005
72559167|NCT01634139|144648078|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.067|STANDARD_ERROR_OF_MEAN|0.037||0.0696|TWO_SIDED|95.0|-0.005|0.139|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|30 minutes post-dose (Week 24)||0.139|-0.005|0.0696
72440627|NCT00390299|144394310|OTHER||Maximum Tolerated Dose (x 10^7 TCID50)|1.0|||||TWO_SIDED|||||||||||||
72495995|NCT03072160|144521583|OTHER|||||||0.21||||||Tregs|Wilcoxon signed-rank test||||A change is defined as being statistically significant (p\>0.05).|||0.210
72495996|NCT03072160|144521583|OTHER|||||||0.78||||||Natural Killer (NK) cells|Wilcoxon signed-rank test||||A change is defined as being statistically significant (p\>0.05).|||0.780
72495997|NCT01058096|144521591|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-4.3||||0.0004|TWO_SIDED|95.0|-6.7|-1.9|||Mixed Models Analysis||cariprazine - placebo|||-1.9|-6.7|0.0004
72495998|NCT01058096|144521592|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.4||||0.0027|TWO_SIDED|95.0|-0.7|-0.1|||MMRM analysis||cariprazine - placebo|||-0.1|-0.7|0.0027
72440628|NCT00390299|144394310|OTHER||Maximum Tolerated Dose (x 10^7 TCID50)|1.0|||||TWO_SIDED|||||||||||||
72440629|NCT00390299|144394314|SUPERIORITY||Hazard Ratio (HR)|1.66||||0.28|TWO_SIDED|95.0|0.67|4.11|||Log Rank|||||4.11|0.67|0.28
72440630|NCT00130117|144394428|SUPERIORITY_OR_OTHER|||||||0.024|||||||ANOVA|||||||0.024
72495999|NCT00408694|144521605|OTHER|||||||||||||||||Null hypothesis, H0: Incidence of patients with either grade 4 hemorrhage or any grade 5 adverse event for the protocol treatment regimen ≤ 0.05. Alternative hypothesis, HA: Incidence of patients with either grade 4 hemorrhage or any grade 5 adverse event for the protocol treatment regimen ≥ 0.15.|If 3 of the first 14 patients or 4 of the first 42 patients experience the specified adverse events, then the regimen is considered unacceptable as calculated by the Fleming method for a two-stage design with type I error and the statistical power were set at 0.14 and 0.83, respectively.|||
72440631|NCT00130117|144394428|SUPERIORITY|||||||0.049|||||||ANOVA|||||||0.049
72440632|NCT00130117|144394429|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.6||||0.02|TWO_SIDED|||||"p value reflects treatment of leptin for on-treatment, n=4"|ANOVA|||||||0.02
72440633|NCT01780298|144394447|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-36.278|||<|0.0001|TWO_SIDED|95.0|-42.203|-30.352|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 1 (COPD) - Group 4 (Never smokers)|||-30.352|-42.203|<0.0001
72440634|NCT01780298|144394447|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-32.739|||<|0.0001|TWO_SIDED|95.0|-38.418|-27.06|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 1 (COPD) - Group 3 (Ex-smokers)|||-27.060|-38.418|<0.0001
72496000|NCT03543410|144521631|SUPERIORITY||Mean Difference (Final Values)|-3.29|STANDARD_ERROR_OF_MEAN|1.625||0.044|TWO_SIDED|95.0|-6.489|-0.09||nominal p-value|Mixed Models Analysis|||||-0.090|-6.489|0.044
72496001|NCT03543410|144521631|SUPERIORITY||Mean Difference (Final Values)|-3.128|STANDARD_ERROR_OF_MEAN|1.597||0.051|TWO_SIDED|95.0|-6.273|0.017||nominal p-value|Mixed Models Analysis|||||0.017|-6.273|0.051
72559168|NCT01634139|144648078|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.109|STANDARD_ERROR_OF_MEAN|0.037||0.0032|TWO_SIDED|95.0|0.037|0.182|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|1 hour post-dose (week 24)||0.182|0.037|0.0032
72440635|NCT01780298|144394447|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-25.265|||<|0.0001|TWO_SIDED|95.0|-31.081|-19.449|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 1 (COPD) - Group 2 (Current cigarette smokers)|||-19.449|-31.081|<0.0001
72496002|NCT03543410|144521632|SUPERIORITY||Mean Difference (Final Values)|-0.281|STANDARD_ERROR_OF_MEAN|0.191||0.143|TWO_SIDED|95.0|-0.658|0.095||nominal p-value|Mixed Models Analysis|||||0.095|-0.658|0.143
72496003|NCT03543410|144521632|SUPERIORITY||Mean Difference (Final Values)|-0.219|STANDARD_ERROR_OF_MEAN|0.187||0.243|TWO_SIDED|95.0|-0.588|0.15||nominal p-value|Mixed Models Analysis|||||0.150|-0.588|0.243
72559169|NCT01634139|144648078|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.06|STANDARD_ERROR_OF_MEAN|0.037||0.1044|TWO_SIDED|95.0|-0.012|0.132|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|1 hour post-dose (week 24)||0.132|-0.012|0.1044
72559170|NCT01634139|144648078|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.113|STANDARD_ERROR_OF_MEAN|0.037||0.0027|TWO_SIDED|95.0|0.039|0.186|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|2 hours post-dose (week 24)||0.186|0.039|0.0027
72559171|NCT01634139|144648078|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.093|STANDARD_ERROR_OF_MEAN|0.037||0.013|TWO_SIDED|95.0|0.02|0.166|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|2 hours post-dose (week 24)||0.166|0.020|0.0130
72559172|NCT01634139|144648078|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.115|STANDARD_ERROR_OF_MEAN|0.038||0.0025|TWO_SIDED|95.0|0.041|0.19|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|3 hours post-dose (week 24)||0.190|0.041|0.0025
72559173|NCT01634139|144648078|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.092|STANDARD_ERROR_OF_MEAN|0.038||0.0156|TWO_SIDED|95.0|0.017|0.166|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|3 hours post-dose (Week 24)||0.166|0.017|0.0156
72440636|NCT01780298|144394447|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.538||||0.1504|TWO_SIDED|95.0|-8.398|1.321|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 3 (Ex-smokers) - Group 4 (Never smokers)|||1.321|-8.398|0.1504
72440637|NCT01780298|144394447|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-7.474||||0.0002|TWO_SIDED|95.0|-11.207|-3.741|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 2 (Current cigarette smokers) - Group 3 (Ex-smokers)|||-3.741|-11.207|0.0002
72440638|NCT01780298|144394447|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-11.013|||<|0.0001|TWO_SIDED|95.0|-15.979|-6.046|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 2 (Current cigarette smokers) - Group 4 (Never smokers)|||-6.046|-15.979|<0.0001
72440639|NCT01780298|144394448|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-27.611|||<|0.0001|TWO_SIDED|95.0|-32.249|-22.973|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 1 (COPD) - Group 4 (Never smokers)|||-22.973|-32.249|<0.0001
72440640|NCT01780298|144394448|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-24.553|||<|0.0001|TWO_SIDED|95.0|-29.501|-19.604|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 1 (COPD) - Group 3 (Ex-smokers)|||-19.604|-29.501|<0.0001
72440641|NCT01780298|144394448|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-14.107|||<|0.0001|TWO_SIDED|95.0|-19.043|-9.17|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 1 (COPD) - Group 2 (Current cigarette smokers)|||-9.170|-19.043|<0.0001
72440642|NCT01780298|144394448|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.058||||0.0983|TWO_SIDED|95.0|-6.702|0.585|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 3 (Ex-smokers) - Group 4 (Never smokers)|||0.585|-6.702|0.0983
72559174|NCT01634139|144648079|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.165|STANDARD_ERROR_OF_MEAN|0.11||0.1349|TWO_SIDED|95.0|-0.382|0.051|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 24||0.051|-0.382|0.1349
72559175|NCT01634139|144648079|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.209|STANDARD_ERROR_OF_MEAN|0.11||0.0588|TWO_SIDED|95.0|-0.425|0.008|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 24||0.008|-0.425|0.0588
72440643|NCT01780298|144394448|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-10.446|||<|0.0001|TWO_SIDED|95.0|-13.845|-7.047|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 2 (Current cigarette smokers) - Group 3 (Ex-smokers)|||-7.047|-13.845|<0.0001
72440644|NCT01780298|144394448|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-13.504|||<|0.0001|TWO_SIDED|95.0|-17.302|-9.707|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 2 (Current cigarette smokers) - Group 4 (Never smokers)|||-9.707|-17.302|<0.0001
72440645|NCT01780298|144394449|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|40.448|||<|0.0001|TWO_SIDED|95.0|28.374|52.521|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 1 (COPD) - Group 4 (Never smokers)|||52.521|28.374|<0.0001
72440646|NCT01780298|144394449|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|26.538|||<|0.0001|TWO_SIDED|95.0|14.89|38.185|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 1 (COPD) - Group 3 (Ex-smokers)|||38.185|14.890|<0.0001
72440647|NCT01780298|144394449|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|20.661||||0.0018|TWO_SIDED|95.0|7.997|33.324|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 1 (COPD) - Group 2 (Current cigarette smokers)|||33.324|7.997|0.0018
72440648|NCT01780298|144394449|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|13.91||||0.0015|TWO_SIDED|95.0|5.534|22.286|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 3 (Ex-smokers) - Group 4 (Never smokers)|||22.286|5.534|0.0015
72440649|NCT01780298|144394449|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.877||||0.1847|TWO_SIDED|95.0|-2.886|14.639|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 2 (Current cigarette smokers) - Group 3 (Ex-smokers)|||14.639|-2.886|0.1847
72559176|NCT01634139|144648079|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.154|STANDARD_ERROR_OF_MEAN|0.111||0.1675|TWO_SIDED|95.0|-0.372|0.065|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 48||0.065|-0.372|0.1675
72559177|NCT01634139|144648079|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.201|STANDARD_ERROR_OF_MEAN|0.111||0.0709|TWO_SIDED|95.0|-0.419|0.017|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 48||0.017|-0.419|0.0709
72440650|NCT01780298|144394449|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|19.787||||0.0003|TWO_SIDED|95.0|9.536|30.038|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 2 (Current cigarette smokers) - Group 4 (Never smokers)|||30.038|9.536|0.0003
72440651|NCT01780298|144394450|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2979.725||||0.1981|TWO_SIDED|95.0|-7560.258|1600.808|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 1 (COPD) - Group 4 (Never smokers)|||1600.808|-7560.258|0.1981
72440652|NCT01780298|144394450|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2317.131||||0.1956|TWO_SIDED|95.0|-1224.786|5859.048|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 1 (COPD) - Group 3 (Ex-smokers)|||5859.048|-1224.786|0.1956
72440653|NCT01780298|144394450|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2396.589||||0.2077|TWO_SIDED|95.0|-1367.692|6160.87|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 1 (COPD) - Group 2 (Current cigarette smokers)|||6160.870|-1367.692|0.2077
72440654|NCT01780298|144394450|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5296.856||||0.1154|TWO_SIDED|95.0|-11930.19|1336.478|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 3 (Ex-smokers) - Group 4 (Never smokers)|||1336.478|-11930.190|0.1154
72440655|NCT01780298|144394450|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-79.458||||0.8095|TWO_SIDED|95.0|-736.151|577.234|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 2 (Current cigarette smokers) - Group 3 (Ex-smokers)|||577.234|-736.151|0.8095
72440656|NCT01780298|144394450|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5376.314||||0.1113|TWO_SIDED|95.0|-12030.714|1278.085|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 2 (Current cigarette smokers) - Group 4 (Never smokers)|||1278.085|-12030.714|0.1113
72440657|NCT01780298|144394451|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|6.015|||<|0.0001|TWO_SIDED|95.0|4.51|7.521|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 1 (COPD) - Group 4 (Never smokers)|||7.521|4.510|<0.0001
72440658|NCT01780298|144394451|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.845|||<|0.0001|TWO_SIDED|95.0|3.379|6.31|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 1 (COPD) - Group 3 (Ex-smokers)|||6.310|3.379|<0.0001
72440659|NCT01780298|144394451|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.454|||<|0.0001|TWO_SIDED|95.0|1.923|4.984|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 1 (COPD) - Group 2 (Current cigarette smokers)|||4.984|1.923|<0.0001
72440660|NCT01780298|144394451|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.171||||0.0418|TWO_SIDED|95.0|0.045|2.296|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 3 (Ex-smokers) - Group 4 (Never smokers)|||2.296|0.045|0.0418
72440661|NCT01780298|144394451|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.391||||0.0357|TWO_SIDED|95.0|0.096|2.686|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 2 (Current cigarette smokers) - Group 3 (Ex-smokers)|||2.686|0.096|0.0357
72440662|NCT01780298|144394451|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.562||||0.0001|TWO_SIDED|95.0|1.303|3.82|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 2 (Current cigarette smokers) - Group 4 (Never smokers)|||3.820|1.303|0.0001
72440663|NCT01780298|144394452|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|39.633|||<|0.0001|TWO_SIDED|95.0|33.964|45.302|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 1 (COPD) - Group 4 (Never smokers)|||45.302|33.964|<0.0001
72440664|NCT01780298|144394452|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|35.792|||<|0.0001|TWO_SIDED|95.0|29.761|41.822|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 1 (COPD) - Group 3 (Ex-smokers)|||41.822|29.761|<0.0001
72440665|NCT01780298|144394452|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|29.167|||<|0.0001|TWO_SIDED|95.0|23.445|34.888|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 1 (COPD) - Group 2 (Current cigarette smokers)|||34.888|23.445|<0.0001
72440666|NCT01780298|144394452|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.842||||0.0418|TWO_SIDED|95.0|0.147|7.536|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 3 (Ex-smokers) - Group 4 (Never smokers)|||7.536|0.147|0.0418
72559178|NCT01634139|144648080|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.116|STANDARD_ERROR_OF_MEAN|0.065||0.0749|TWO_SIDED|95.0|-0.245|0.012|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 24||0.012|-0.245|0.0749
72559179|NCT01634139|144648080|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.141|STANDARD_ERROR_OF_MEAN|0.065||0.0305|TWO_SIDED|95.0|-0.269|-0.013|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 24||-0.013|-0.269|0.0305
72440667|NCT01780298|144394452|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|6.625||||0.0084|TWO_SIDED|95.0|1.763|11.487|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 2 (Current cigarette smokers) - Group 3 (Ex-smokers)|||11.487|1.763|0.0084
72440668|NCT01780298|144394452|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|10.467|||<|0.0001|TWO_SIDED|95.0|5.888|15.045|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 2 (Current cigarette smokers) - Group 4 (Never smokers)|||15.045|5.888|<0.0001
72440669|NCT01780298|144394453|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.929|||<|0.0001|TWO_SIDED|95.0|0.654|1.203|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 1 (COPD) - Group 4 (Never smokers)|||1.203|0.654|<0.0001
72440670|NCT01780298|144394453|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.875|||<|0.0001|TWO_SIDED|95.0|0.609|1.141|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 1 (COPD) - Group 3 (Ex-smokers)|||1.141|0.609|<0.0001
72440671|NCT01780298|144394453|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.649|||<|0.0001|TWO_SIDED|95.0|0.386|0.912|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 1 (COPD) - Group 2 (Current cigarette smokers)|||0.912|0.386|<0.0001
72496004|NCT00666926|144521646|SUPERIORITY_OR_OTHER||Ratio (percent) test / reference|155.66|||||TWO_SIDED|90.0|109.66|220.95|||||Ratio of adjusted geometric means Day 21 versus Day 1. Values have been transformed from the log scale.|Participants in the PF-00562271 125 mg BID cohort who received MDZ (test) administered prior to PF-00562271 (reference) dosing.||220.95|109.66|
72496005|NCT00666926|144521647|SUPERIORITY_OR_OTHER||Ratio (percent) test / reference|315.72|||||TWO_SIDED|90.0|227.6|437.97|||||Ratio of adjusted geometric means Day 21 versus Day 1. Values have been transformed from the log scale.|Participants in the PF-00562271 125 mg BID cohort who received MDZ (test) administered prior to PF-00562271 (reference) dosing.||437.97|227.60|
72496006|NCT00666926|144521648|SUPERIORITY_OR_OTHER||Ratio (percent) test / reference|496.63|||||TWO_SIDED|90.0|206.24|1195.92|||||Ratio of adjusted geometric means Day 21 versus Day 1. Values have been transformed from the log scale.|Participants in the PF-00562271 125 mg BID cohort who received MDZ (test) administered prior to PF-00562271 (reference) dosing.||1195.92|206.24|
72440672|NCT01780298|144394453|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.069||||0.3985|TWO_SIDED|95.0|-0.093|0.231|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 3 (Ex-smokers) - Group 4 (Never smokers)|||0.231|-0.093|0.3985
72440673|NCT01780298|144394453|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.22||||0.0267|TWO_SIDED|95.0|0.026|0.414|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 2 (Current cigarette smokers) - Group 3 (Ex-smokers)|||0.414|0.026|0.0267
72440674|NCT01780298|144394453|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.305||||0.0036|TWO_SIDED|95.0|0.104|0.506|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 2 (Current cigarette smokers) - Group 4 (Never smokers)|||0.506|0.104|0.0036
72440675|NCT01780298|144394454|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.564|||<|0.0001|TWO_SIDED|95.0|1.179|1.949|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 1 (COPD) - Group 4 (Never smokers)|||1.949|1.179|<0.0001
72440676|NCT01780298|144394454|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.291|||<|0.0001|TWO_SIDED|95.0|0.924|1.658|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 1 (COPD) - Group 3 (Ex-smokers)|||1.658|0.924|<0.0001
72496007|NCT00820755|144521658|SUPERIORITY_OR_OTHER||Hazard Ratio, log|0.959||||0.1265|TWO_SIDED|95.0|0.736|1.25|||Log Rank|||Exploratory analysis to test the null hypothesis of no difference between maintenance therapy regimen. Model is adjusted by histology (interactive voice response system \[IVRS\]) and tumor response status at the end of combination therapy ('complete response \[CR\] or partial response \[PR\]' versus 'other').||1.250|0.736|0.1265
72496008|NCT00820755|144521660|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.774||||0.0622||95.0|0.613|0.976|||Log Rank|||Exploratory analysis to test the null hypothesis of no difference between maintenance therapy regimen. Model is adjusted by histology (IVRS) and tumor response status at the end of combination therapy ('CR or PR' versus 'other').||0.976|0.613|0.0622
72440677|NCT01780298|144394454|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.073|||<|0.0001|TWO_SIDED|95.0|0.724|1.421|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 1 (COPD) - Group 2 (Current cigarette smokers)|||1.421|0.724|<0.0001
72440678|NCT01780298|144394454|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.276||||0.0282|TWO_SIDED|95.0|0.031|0.521|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 3 (Ex-smokers) - Group 4 (Never smokers)|||0.521|0.031|0.0282
72496009|NCT00091832|144521682|SUPERIORITY_OR_OTHER|||||||0.245|||||||ANCOVA|Adjusted for the stratum to which the participant was originally assigned by the Interactive Voice Response System (IVRS)||||||0.245
72496010|NCT00091832|144521683|SUPERIORITY_OR_OTHER|||||||0.848|||||||ANCOVA|Adjusted for the stratum to which the participant was originally assigned by the Interactive Voice Response System (IVRS)||||||0.848
72496011|NCT00091832|144521684|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.72||||||95.0|0.68|4.35|||||Adjusted for the stratum to which the participant was originally assigned by the Interactive Voice Response System (IVRS)|||4.35|0.68|
72496012|NCT00091832|144521684|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.29||||||95.0|0.51|3.24|||||Adjusted for the stratum to which the participant was originally assigned by the Interactive Voice Response System (IVRS)|||3.24|0.51|
72496013|NCT00091832|144521684|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.88||||||95.0|0.34|2.29|||||Adjusted for the stratum to which the participant was originally assigned by the Interactive Voice Response System (IVRS)|||2.29|0.34|
72440679|NCT01780298|144394454|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.207||||0.1223|TWO_SIDED|95.0|-0.057|0.471|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 2 (Current cigarette smokers) - Group 3 (Ex-smokers)|||0.471|-0.057|0.1223
72440680|NCT01780298|144394454|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.492|||<|0.0001|TWO_SIDED|95.0|0.273|0.71|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 2 (Current cigarette smokers) - Group 4 (Never smokers)|||0.710|0.273|<0.0001
72440681|NCT01780298|144394455|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.372|||<|0.0001|TWO_SIDED|95.0|0.269|0.478|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 1 (COPD) - Group 4 (Never smokers)|||0.478|0.269|<0.0001
72440682|NCT01780298|144394455|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.256|||<|0.0001|TWO_SIDED|95.0|0.158|0.354|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 1 (COPD) - Group 3 (Ex-smokers)|||0.354|0.158|<0.0001
72440683|NCT01780298|144394455|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.136||||0.0199|TWO_SIDED|95.0|0.022|0.249|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 1 (COPD) - Group 2 (Current cigarette smokers)|||0.249|0.022|0.0199
72440684|NCT01780298|144394455|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.117||||0.0247|TWO_SIDED|95.0|0.015|0.218|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 3 (Ex-smokers) - Group 4 (Never smokers)|||0.218|0.015|0.0247
72496014|NCT00091832|144521684|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.27||||||95.0|0.51|3.2|||||Adjusted for the stratum to which the participant was originally assigned by the Interactive Voice Response System (IVRS)|||3.20|0.51|
72496015|NCT00091832|144521684|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.74||||||95.0|0.7|4.34|||||Adjusted for the stratum to which the participant was originally assigned by the Interactive Voice Response System (IVRS)|||4.34|0.70|
72440685|NCT01780298|144394455|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.12||||0.0204|TWO_SIDED|95.0|0.019|0.221|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 2 (Current cigarette smokers) - Group 3 (Ex-smokers)|||0.221|0.019|0.0204
72440686|NCT01780298|144394455|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.237|||<|0.0001|TWO_SIDED|95.0|0.127|0.347|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 2 (Current cigarette smokers) - Group 4 (Never smokers)|||0.347|0.127|<0.0001
72440687|NCT05489484|144394504|OTHER|Paired-sample t-test was used to assess the change in Constant-Murley Score from baseline to 3 months.|Mean Difference (Net)|10.03|STANDARD_ERROR_OF_MEAN|2.124||0.001|TWO_SIDED|95.0|3.63|16.0|||t-test, 2 sided||Mean change from baseline in CMS at 3 months. Higher scores represent better shoulder function. Positive difference indicates clinical improvement.|Statistical analysis was performed on 23 participants with valid Constant-Murley Score (CMS) data at both baseline and 3-month follow-up.||16.00|3.63|0.001
72440688|NCT00444600|144394516|SUPERIORITY_OR_OTHER_LEGACY||Difference in mean change|-55.0|||<|0.001|TWO_SIDED|95.0|-78.0|-32.0||Confidence intervals are adjusted for multiple comparisons.|ANCOVA|Adjusted for baseline retinal thickness and visual acuity and correlation between two study eyes.||Difference in central subfield thickness mean change from sham+prompt laser||-32|-78|<0.001
72440689|NCT00444600|144394516|SUPERIORITY_OR_OTHER_LEGACY||Difference in mean change|-49.0|||<|0.001|TWO_SIDED|95.0|-72.0|-26.0||Confidence intervals are adjusted for multiple comparisons.|ANCOVA|Adjusted for baseline retinal thickness and visual acuity and correlation between two study eyes.||Difference in optical coherence tomography central subfield thickness mean change from sham+prompt laser||-26|-72|<0.001
72440690|NCT00444600|144394516|SUPERIORITY_OR_OTHER_LEGACY||Difference in mean change|-52.0|||<|0.001|TWO_SIDED|95.0|-75.0|-29.0||Confidence interval is adjusted for multiple comparisons|ANCOVA|Adjusted for baseline retinal thickness and visual acuity and correlation between two study eyes.||Difference in optical coherence tomography central subfield thickness mean change from sham+prompt laser||-29|-75|<0.001
72440691|NCT00444600|144394518|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.8|||<|0.001|TWO_SIDED|95.0|3.2|8.5||Adjusted for multiple comparisons.|ANCOVA|Adjusted for baseline visual acuity and correlation between 2 study eyes.||||8.5|3.2|<0.001
72440692|NCT00444600|144394518|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|6.0|||<|0.001|TWO_SIDED|95.0|3.4|8.6||Adjusted for multiple comparisons.|ANCOVA|Adjusted for baseline visual acuity and correlation between 2 study eyes.||||8.6|3.4|<0.001
72440693|NCT00444600|144394518|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.1||||0.31|TWO_SIDED|95.0|-1.5|3.7||Adjusted for multiple comparisons.|ANCOVA|Adjusted for baseline visual acuity and correlation between 2 study eyes.||||3.7|-1.5|0.31
72496016|NCT00091832|144521685|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.82||||||95.0|0.69|4.79|||||Adjusted for the stratum to which the participant was originally assigned by the Interactive Voice Response System (IVRS)|||4.79|0.69|
72496017|NCT00091832|144521685|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.67||||||95.0|0.25|1.76|||||Adjusted for the stratum to which the participant was originally assigned by the Interactive Voice Response System (IVRS)|||1.76|0.25|
72496018|NCT00091832|144521685|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.65||||||95.0|0.24|1.77|||||Adjusted for the stratum to which the participant was originally assigned by the Interactive Voice Response System (IVRS)|||1.77|0.24|
72496019|NCT00091832|144521685|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.58||||||95.0|0.22|1.58|||||Adjusted for the stratum to which the participant was originally assigned by the Interactive Voice Response System (IVRS)|||1.58|0.22|
72440694|NCT00444600|144394519|SUPERIORITY_OR_OTHER_LEGACY||Proportion|23.0|||||TWO_SIDED|95.0|13.0|34.0||Confidence intervals are adjusted for multiple comparisons.|Binomial regression|Adjusted for correlation between 2 study eyes and multiple comparisons.||Difference in proportion with ≥10 letter improvement for sham+prompt laser at 1 year||34|13|
72440695|NCT00444600|144394519|SUPERIORITY_OR_OTHER_LEGACY||Proportion|19.0|||||TWO_SIDED|95.0|9.0|29.0||Confidence intervals adjusted for multiple comparisons|Binomial regression|Adjusted for correlation between 2 study eyes and multiple comparisons.||Difference in proportion with ≥10 letter improvement from sham+prompt laser at 1 year||29|9|
72440696|NCT00444600|144394519|SUPERIORITY_OR_OTHER_LEGACY||Proportion|6.0|||||TWO_SIDED|95.0|-4.0|16.0||Confidence intervals adjusted for multiple comparisons|Binomial regression|Adjusted for correlation between 2 study eyes and multiple comparisons.||Difference in proportion with ≥10 letter improvement from sham+prompt laser at 1 year||16|-4|
72440697|NCT00444600|144394519|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|1.84|||<|0.001|TWO_SIDED|95.0|1.4|2.42||Confidence intervals are adjusted for multiple comparisons.|Log-Binomial Regression|Adjusted for correlation between 2 study eyes and multiple comparisons.||Relative risk for ≥10 letter improvement comparison with sham+prompt laser at 1 year||2.42|1.40|<0.001
72440698|NCT00444600|144394519|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|1.68|||<|0.001|TWO_SIDED|95.0|1.27|2.21||Confidence intervals are adjusted for multiple comparisons.|Log-Binomial Regression|Adjusted for correlation between 2 study eyes and multiple comparisons.||Relative risk for ≥10 letter improvement comparison with sham+prompt laser at 1 year||2.21|1.27|<0.001
72440699|NCT00444600|144394519|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|1.21||||0.16|TWO_SIDED|95.0|0.88|1.66||Confidence intervals are adjusted for multiple comparisons.|Log-Binomial Regression|Adjusted for correlation between 2 study eyes and multiple comparisons.|Eyes were analyzed.|Relative risk for ≥10 letter improvement comparison with sham+prompt laser at 1 year||1.66|0.88|0.16
72440700|NCT00444600|144394519|SUPERIORITY_OR_OTHER_LEGACY||Proportion|-10.0|||||TWO_SIDED|95.0|-16.0|-5.0||Confidence intervals are adjusted for multiple comparisons.|Binomial Regression|Adjusted for correlation between 2 study eyes and multiple comparisons.||Difference in proportion with ≥10 letter worsening from sham+prompt laser at 1 year||-5|-16|
72440701|NCT00444600|144394519|SUPERIORITY_OR_OTHER_LEGACY||Proportion|-10.0|||||TWO_SIDED|95.0|-16.0|-4.0||Confidence intervals are adjusted for multiple comparisons.|Binomial Regression|Adjusted for correlation between 2 study eyes and multiple comparisons.||Difference in proportion with ≥10 letter worsening from sham+prompt laser at 1 year||-4|-16|
72496020|NCT00091832|144521685|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.7||||||95.0|0.25|1.92|||||Adjusted for the stratum to which the participant was originally assigned by the Interactive Voice Response System (IVRS)|||1.92|0.25|
72496021|NCT00091832|144521686|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.82||||||95.0|0.51|1.31|||||A hazard ratio \>1 indicates that the time to 65% or more reduction in uNTx from baseline was shorter in the Denosumab-treated group than in the control group.|||1.31|0.51|
72440702|NCT00444600|144394519|SUPERIORITY_OR_OTHER_LEGACY||Proportion|1.0|||||TWO_SIDED|95.0|-7.0|9.0||Confidence intervals are adjusted for multiple comparisons.|Binomial Regression|Adjusted for correlation between 2 study eyes and multiple comparisons.||Difference in proportion with ≥10 letter worsening from sham+prompt laser at 1 year||9|-7|
72440703|NCT00444600|144394519|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.24|||<|0.001|TWO_SIDED|95.0|0.09|0.65||Confidence intervals are adjusted for multiple comparisons.|Log-Binomial Regression|Adjusted for correlation between 2 study eyes and multiple comparisons.||Relative risk for ≥10 letter worsening comparison with sham+prompt laser at 1 year||0.65|0.09|<0.001
72440704|NCT00444600|144394519|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.24||||0.001|TWO_SIDED|95.0|0.08|0.68||Confidence intervals are adjusted for multiple comparisons.|Log-Binomial Regression|Adjusted for correlation between 2 study eyes and multiple comparisons.||Relative risk for ≥10 letter worsening comparison with sham+prompt laser at 1 year||0.68|0.08|0.001
72440705|NCT00444600|144394519|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|1.08||||0.75|TWO_SIDED|95.0|0.62|1.87||Confidence intervals are adjusted for multiple comparisons.|Log-Binomial Regression|Adjusted for correlation between 2 study eyes and multiple comparisons.||Relative risk for ≥10 letter worsening comparison with sham+prompt laser at 1 year||1.87|0.62|0.75
72440706|NCT00444600|144394519|SUPERIORITY_OR_OTHER_LEGACY||Proportion|16.0|||||TWO_SIDED|95.0|6.0|26.0||Confidence intervals are adjusted for multiple comparisons.|Binomial Regression|Adjusted for correlation between to study eyes.||Difference in proportion with ≥15 letter improvement from sham+prompt laser at 1 year||26|6|
72440707|NCT00444600|144394519|SUPERIORITY_OR_OTHER_LEGACY||Proportion|13.0|||||TWO_SIDED|95.0|4.0|22.0||Confidence intervals are adjusted for multiple comparisons.|Binomial Regression|Adjusted for correlation between 2 study eyes and multiple comparisons.||Difference in proportion with ≥15 letter improvement from sham+prompt laser at 1 year||22|4|
72440708|NCT00444600|144394519|SUPERIORITY_OR_OTHER_LEGACY||Proportion|6.0|||||TWO_SIDED|95.0|-2.0|15.0||Confidence intervals are adjusted for multiple comparisons.|Binomial Regression|Adjusted for correlation between 2 study eyes and multiple comparisons.||Difference in proportion with ≥15 letter improvement from sham+prompt laser at 1 year||15|-2|
72496022|NCT00091832|144521686|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.03||||||95.0|0.64|1.65|||||A hazard ratio \>1 indicates that the time to 65% or more reduction in uNTx from baseline was shorter in the Denosumab-treated group than in the control group.|||1.65|0.64|
72496023|NCT00091832|144521686|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.09||||||95.0|0.68|1.74|||||A hazard ratio \>1 indicates that the time to 65% or more reduction in uNTx from baseline was shorter in the Denosumab-treated group than in the control group.|||1.74|0.68|
72496024|NCT00091832|144521686|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.09||||||95.0|0.68|1.74|||||A hazard ratio \>1 indicates that the time to 65% or more reduction in uNTx from baseline was shorter in the Denosumab-treated group than in the control group.|||1.74|0.68|
72496025|NCT00091832|144521686|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.14||||||95.0|0.71|1.83|||||A hazard ratio \>1 indicates that the time to 65% or more reduction in uNTx from baseline was shorter in the Denosumab-treated group than in the control group.|||1.83|0.71|
72496026|NCT00091832|144521697|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.543||||||95.0|0.159|1.856|||||A hazard ratio \<1 indicates the time to the first skeletal-related event in the denosumab-treated group was longer than that in the control group.|||1.856|0.159|
72496027|NCT00091832|144521697|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.544||||||95.0|0.159|1.859|||||A hazard ratio \<1 indicates the time to the first skeletal-related event in the denosumab-treated group was longer than that in the control group.|||1.859|0.159|
72440709|NCT00444600|144394519|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|2.09|||<|0.001|TWO_SIDED|95.0|1.35|3.22|||Log-Binomial Regression|Adjusted for correlation between 2 study eyes and multiple comparisons.||Relative risk for ≥15 letter improvement comparison with sham+prompt laser at 1 year||3.22|1.35|<0.001
72440710|NCT00444600|144394519|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|1.89|||<|0.001|TWO_SIDED|95.0|1.25|2.87||Confidence intervals are adjusted for multiple comparisons.|Log-Binomial Regression|Adjusted for correlation between 2 study eyes and multiple comparisons.||Relative risk for ≥15 letter improvement comparison with sham+prompt laser at 1 year||2.87|1.25|<0.001
72440711|NCT00444600|144394519|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|1.43||||0.07|TWO_SIDED|95.0|0.9|2.29||Confidence intervals are adjusted for multiple comparisons.|Log-Binomial Regression|Adjusted for correlation between 2 study eyes and multiple comparisons.||Relative risk for ≥15 letter improvement comparison with sham+prompt laser at 1 year||2.29|0.90|0.07
72440712|NCT00444600|144394519|SUPERIORITY_OR_OTHER_LEGACY||Proportion|-6.0|||||TWO_SIDED|95.0|-11.0|-2.0||Confidence intervals are adjusted for multiple comparisons.|Binomial Regression|Adjusted for correlation between 2 study eyes and multiple comparisons.||Difference in proportion with ≥15 letter worsening from sham+prompt laser at 1 year||-2|-11|
72440713|NCT00444600|144394519|SUPERIORITY_OR_OTHER_LEGACY||Proportion|-6.0|||||TWO_SIDED|95.0|-10.0|-1.0||Confidence intervals are adjusted for multiple comparisons.|Binomial Regression|Adjusted for correlation between 2 study eyes and multiple comparisons.||Difference in proportion with ≥15 letter worsening from sham+prompt laser at 1 year||-1|-10|
72440714|NCT00444600|144394519|SUPERIORITY_OR_OTHER_LEGACY||Proportion|0.0|||||TWO_SIDED|95.0|-6.0|6.0||Confidence intervals are adjusted for multiple comparisons.|Binomial Regression|Adjusted for correlation between 2 study eyes and multiple comparisons.||Difference in proportion with ≥15 letter worsening from sham+prompt laser at 1 year||6|-6|
72440715|NCT00444600|144394519|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.21||||0.009|TWO_SIDED|95.0|0.05|0.87|||Log-Binomial Regression|Adjusted for correlation between 2 study eyes and multiple comparisons.||Relative risk for ≥15 letter worsening comparison with sham+prompt laser at 1 year||0.87|0.05|0.009
72496028|NCT00091832|144521697|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.791||||||95.0|0.266|2.355|||||A hazard ratio \<1 indicates the time to the first skeletal-related event in the denosumab-treated group was longer than that in the control group.|||2.355|0.266|
72440716|NCT00444600|144394519|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.28||||0.01|TWO_SIDED|95.0|0.08|0.97|||Log-Binomial Regression|Adjusted for correlation between 2 study eyes and multiple comparisons.||Relative risk for ≥15 letter worsening comparison with sham+prompt laser at 1 year||0.97|0.08|0.01
72440717|NCT00444600|144394519|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|1.02||||0.95|TWO_SIDED|95.0|0.47|2.2|||Log-Binomial Regression|Adjusted for correlation between 2 study eyes and multiple comparisons.||Relative risk for ≥15 letter worsening comparison with sham+prompt laser at 1 year||2.20|0.47|0.95
72496029|NCT00091832|144521697|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.073||||||95.0|0.389|2.963|||||A hazard ratio \<1 indicates the time to the first skeletal-related event in the denosumab-treated group was longer than that in the control group.|||2.963|0.389|
72440718|NCT00444600|144394520|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|2.0|||<|0.001|TWO_SIDED|95.0|1.52|2.64||Confidence intervals are adjusted for multiple comparisons.|Regression, Logistic|Adjusted for correlation between 2 study eyes and multiple comparisons.||Relative risk for comparison with sham+prompt laser||2.64|1.52|<0.001
72440719|NCT00444600|144394520|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|1.55||||0.001|TWO_SIDED|95.0|1.13|2.13||Confidence intervals adjusted for multiple comparisons|Regression, Logistic|Adjusted for correlation between 2 study eyes and multiple comparisons.||Relative risk for comparison with sham+prompt laser||2.13|1.13|0.001
72440720|NCT00444600|144394520|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|1.76|||<|0.001||95.0|1.31|2.36||Confidence intervals adjusted for multiple comparisons.|Regression, Logistic|Adjusted for correlation between 2 study eyes and multiple comparisons.||Relative risk for comparison with sham+prompt laser||2.36|1.31|<0.001
72440721|NCT00444600|144394530|SUPERIORITY_OR_OTHER_LEGACY|||||||0.08||95.0|||||GEE repeated measures|||P value for comparison with sham||||0.08
72440722|NCT00444600|144394530|SUPERIORITY_OR_OTHER_LEGACY|||||||0.17||95.0|||||GEE repeated measures|||P value for comparison with sham||||0.17
72440723|NCT00444600|144394531|SUPERIORITY_OR_OTHER_LEGACY|||||||0.03||95.0|||||GEE repeated measures|||P value for comparison with sham||||0.03
72440724|NCT00444600|144394531|SUPERIORITY_OR_OTHER_LEGACY|||||||0.17||95.0|||||GEE repeated measures|||P value for comparison with sham||||0.17
72440725|NCT00444600|144394535|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.73|||<|0.001|TWO_SIDED|95.0|-1.01|-0.44||Confidence intervals are adjusted for multiple comparisons.|ANCOVA|Adjusted for baseline optical coherence tomography (OCT) retinal volume, OCT retinal thickness and visual acuity and correlation between 2 study eyes.||Difference in mean change from sham+prompt laser||-0.44|-1.01|<0.001
72440726|NCT00444600|144394535|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.68|||<|0.001|TWO_SIDED|95.0|-0.96|-0.41||Confidence intervals adjusted for multiple comparisons.|ANCOVA|Adjusted for baseline optical coherence tomography (OCT) retinal volume, OCT retinal thickness and visual acuity and correlation between 2 study eyes.||Difference in mean change from sham+prompt laser||-0.41|-0.96|<0.001
72496030|NCT00091832|144521697|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.54||||||95.0|0.158|1.847|||||A hazard ratio \<1 indicates the time to the first skeletal-related event in the denosumab-treated group was longer than that in the control group.|||1.847|0.158|
72496031|NCT00091832|144521698|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.92||||||95.0|0.51|7.17|||||Adjusted for the stratum to which the participant was originally assigned by the Interactive Voice Response System (IVRS)|||7.17|0.51|
72496032|NCT00091832|144521698|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.2||||||95.0|0.36|3.97|||||Adjusted for the stratum to which the participant was originally assigned by the Interactive Voice Response System (IVRS)|||3.97|0.36|
72496033|NCT00091832|144521698|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.81||||||95.0|0.26|2.52|||||Adjusted for the stratum to which the participant was originally assigned by the Interactive Voice Response System (IVRS)|||2.52|0.26|
72496034|NCT00091832|144521698|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.88||||||95.0|0.5|7.05|||||Adjusted for the stratum to which the participant was originally assigned by the Interactive Voice Response System (IVRS)|||7.05|0.5|
72496035|NCT00091832|144521698|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.88||||||95.0|0.5|7.05|||||Adjusted for the stratum to which the participant was originally assigned by the Interactive Voice Response System (IVRS)|||7.05|0.5|
72619006|NCT03615534|144768410|SUPERIORITY|||||||0.966||||||Results were evaluated in terms of adjusted end line systolic blood pressure levels, embracing the least significant difference (LSD) for pair-wise comparison. Probability of less than 0.05 was considered statistically significant.|ANCOVA|Covariates appearing in ANCOVA model are evaluated at the following baseline values: systolic blood pressure= 121.5 mmHg.||Analysis of Covariance (ANCOVA), was applied to assess treatment effects among different arms, comprising the influence of the baseline systolic blood pressure level as a covariate.||||0.966
72440727|NCT00444600|144394535|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.62|||<|0.001|TWO_SIDED|95.0|-0.91|-0.34||Confidence intervals are adjusted for multiple comparisons.|ANCOVA|Adjusted for baseline optical coherence tomography (OCT) retinal volume, OCT retinal thickness and visual acuity and correlation between 2 study eyes.||Difference in mean change from sham+prompt laser||-0.34|-0.91|<0.001
72440728|NCT05132478|144394537|SUPERIORITY|||||||0.72|||||||Regression, Logistic|||||||0.720
72440729|NCT05132478|144394538|SUPERIORITY|||||||0.743|||||||t-test, 2 sided|||||||0.743
72440730|NCT05132478|144394539|SUPERIORITY|||||||0.228|||||||t-test, 2 sided|||baseline||||0.228
72440731|NCT05132478|144394539|SUPERIORITY|||||||0.176|||||||t-test, 2 sided|||Post-Intervention||||0.176
72440732|NCT05132478|144394540|SUPERIORITY|||||||0.41|||||||t-test, 2 sided|||baseline||||0.410
72440733|NCT05132478|144394540|SUPERIORITY|||||||0.351|||||||ANOVA|||Post-Intervention||||0.351
72440734|NCT05132478|144394541|SUPERIORITY||||||<|0.001||||||calculated p-value|t-test, 2 sided|||||||<0.001
72440735|NCT05132478|144394542|SUPERIORITY||||||<|0.001||||||calculated p-value|t-test, 2 sided|||||||<0.001
72440736|NCT00106080|144394543|SUPERIORITY_OR_OTHER_LEGACY||Difference between groups after adjust|5.7||||0.03||||||No multiple comparisons, a priori threshold \< 0.05|GEE regression|Generalized estimating equations (GEE) regression, clustering for provider.||Power calculation: With 60 providers in each group, maintaining the probability of a type I error of 0.05, power of 0.90, provider level mean QOC score of 54.5 and provider level standard deviation in QOC score of 12.0, the minimal detectable difference in QOC score would be 7.5.||||0.03
72440737|NCT01852071|144394545|SUPERIORITY||Difference in percentages|14.29|||||TWO_SIDED|95.0|-5.4|42.81||||||Percentage of patients alive at 1-year post-treatment in the historical control groups (without MRD) were compared to the percentage of study patients alive at 1-year post-treatment with OTL-101. Results are reported as percentage difference in OS of historical control group from OTL-101 on-study subjects.||42.81|-5.40|
72440738|NCT01852071|144394545|SUPERIORITY||Difference in percentages|0.0|||||TWO_SIDED|||||||||Percentage of patients alive at 1-year post-treatment in the historical control groups (with MRD) were compared to the percentage of study patients alive at 1-year post-treatment with OTL-101. Results are reported as percentage difference in OS of historical control group from OTL-101 on-study subjects.||||
72440739|NCT01852071|144394545|SUPERIORITY||Difference in percentages|7.69|||||TWO_SIDED|95.0|-10.08|25.13||||||Percentage of patients alive at 1-year post-treatment in the historical control groups (all control patients) were compared to the percentage of study patients alive at 1-year post-treatment with OTL-101. Results are reported as percentage difference in OS of historical control group from OTL-101 on-study subjects.||25.13|-10.08|
72440740|NCT01852071|144394546|SUPERIORITY||Difference in percentages|35.71|||||TWO_SIDED|95.0|11.21|64.86||||||Percentage of patients with EvFS at 1-year post-treatment in the historical control groups (without MRD) were compared to the percentage of study patients with EvFS at 1-year post-treatment with OTL-101. Results are reported as percentage difference in EvFS of historical control group from OTL-101 on-study subjects.||64.86|11.21|
72440741|NCT01852071|144394546|SUPERIORITY||Difference in percentages|0.0|||||TWO_SIDED|||||||||Percentage of patients with EvFS at 1-year post-treatment in the historical control groups (with MRD) were compared to the percentage of study patients with EvFS at 1-year post-treatment with OTL-101. Results are reported as percentage difference in EvFS of historical control group from OTL-101 on-study subjects.||||
72440742|NCT01852071|144394546|SUPERIORITY||Difference in percentages|19.23|||||TWO_SIDED|95.0|0.71|39.35||||||Percentage of patients with EvFS at 1-year post-treatment in the historical control groups (all control patients) were compared to the percentage of study patients with EvFS at 1-year post-treatment with OTL-101. Results are reported as percentage difference in EvFS of historical control group from OTL-101 on-study subjects.||39.35|0.71|
72440743|NCT01852071|144394547|SUPERIORITY||Difference in percentages|14.29|||||TWO_SIDED|95.0|-5.4|42.81||||||Percentage of patients alive at 2-years post-treatment in the historical control groups (without MRD) were compared to the percentage of study patients alive at 2-years post-treatment with OTL-101. Results are reported as percentage difference in OS of historical control group from OTL-101 on-study subjects.||42.81|-5.40|
72440744|NCT01852071|144394547|SUPERIORITY||Difference in percentages|9.09|||||TWO_SIDED|95.0|-9.55|41.28||||||Percentage of patients alive at 2-years post-treatment in the historical control groups (with MRD) were compared to the percentage of study patients alive at 2-years post-treatment with OTL-101. Results are reported as percentage difference in OS of historical control group from OTL-101 on-study subjects.||41.28|-9.55|
72440745|NCT01852071|144394547|SUPERIORITY||Difference in percentages|12.0|||||TWO_SIDED|95.0|-5.62|31.22||||||Percentage of patients alive at 2-years post-treatment in the historical control groups (all control patients) were compared to the percentage of study patients alive at 2-years post-treatment with OTL-101. Results are reported as percentage difference in OS of historical control group from OTL-101 on-study subjects.||31.22|-5.62|
72440746|NCT01852071|144394548|SUPERIORITY||Difference in percentages|50.0|||||TWO_SIDED|95.0|22.71|76.96||||||Percentage of patients with EvFS at 2-years post-treatment in the historical control groups (without MRD) were compared to the percentage of study patients with EvFS at 2-years post-treatment with OTL-101. Results are reported as percentage difference in EvFS of historical control group from OTL-101 on-study subjects.||76.96|22.71|
72440747|NCT01852071|144394548|SUPERIORITY||Difference in percentages|36.36|||||TWO_SIDED|95.0|9.8|69.21||||||Percentage of patients with EvFS at 2-years post-treatment in the historical control groups (with MRD) were compared to the percentage of study patients with EvFS at 2-years post-treatment with OTL-101. Results are reported as percentage difference in EvFS of historical control group from OTL-101 on-study subjects.||69.21|9.80|
72440748|NCT01852071|144394548|SUPERIORITY||Difference in percentages|44.0|||||TWO_SIDED|95.0|22.78|65.23||||||Percentage of patients with EvFS at 2-years post-treatment in the historical control groups (all control patients) were compared to the percentage of study patients with EvFS at 2-years post-treatment with OTL-101. Results are reported as percentage difference in EvFS of historical control group from OTL-101 on-study subjects.||65.23|22.78|
72559180|NCT01634139|144648080|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.125|STANDARD_ERROR_OF_MEAN|0.066||0.0581|TWO_SIDED|95.0|-0.255|0.004|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 48||0.004|-0.255|0.0581
72440749|NCT01839331|144394574|SUPERIORITY|||||||0.004||||||Adjusted for injection volume (4 mL or 10 mL) and baseline WOMAC score.|ANOVA|||||||0.004
72440750|NCT01839331|144394574|SUPERIORITY|||||||0.017||||||Adjusted for injection volume and baseline WOMAC score.|ANOVA|||||||0.017
72440751|NCT01839331|144394574|SUPERIORITY|||||||0.093||||||Adjusted for injection volume and baseline WOMAC score.|ANOVA|||||||0.093
72440752|NCT01839331|144394575|SUPERIORITY|Adjusted for injection volume (4 mL or 10 mL) and baseline WOMAC score.||||||0.0442|||||||ANOVA|||||||0.0442
72440753|NCT01839331|144394576|SUPERIORITY|||||||0.4133||||||Adjusted for injection volume (4 mL or 10 mL) and baseline WOMAC score.|ANOVA|||||||0.4133
72440754|NCT01839331|144394577|SUPERIORITY|||||||0.0122||||||Adjusted for injection volume (4 mL or 10 mL) and baseline PGA|ANOVA|||||||0.0122
72440755|NCT00703820|144394580|SUPERIORITY||Odds Ratio (OR)|1.87||||0.035|TWO_SIDED|95.0|1.03|3.41||The p-value is not adjusted for multiple comparisons. The a priori threshold for statistical significance is 0.0429 so that the overall level of the study is maintained at 0.05 across the 4 interim analyses and the final analysis.|Cochran-Mantel-Haenszel|The p-value was computed using an exact, risk-group stratified, two-sided test.|The odds ratio is defined as the ratio of the odds that a Clofarabine+Cytarabine patient is MRD positive to the odds that a Cytarabine+Daunorubicin+Etoposide patient is MRD positive.|The study was designed to test the null hypothesis that Cytarabine+Daunorubicin+Etoposide and Clofarabine+Cytarabine result in the same proportion of patients with positive MRD after 22 days. Power calculations indicate that enrollment of a total of 240 MRD-evaluable patients in a 5-stage Haybittle-Peto group sequential design gives 80% power at the 5% level to detect an odds ratio of 2.5. The design was developed using East statistical software.||3.41|1.03|0.035
72440756|NCT01985334|144394621|SUPERIORITY_OR_OTHER|||||||0.018|||||||linear mixed model|||||||0.0180
72440757|NCT01985334|144394622|NON_INFERIORITY_OR_EQUIVALENCE|"H0: Glycopyrronium (50 μg o.d.) \[randomized group B2\] was inferior to LABA or LAMA (random group B1) with respect to mean trough FEV1 after 12 weeks of treatment.~H0: μFEV1, NVA237 - μFEV1, LABA and/or LAMA \< -40 mL Ha: Glycopyrronium (50 μg o.d.) \[randomized group B2\] is non-inferior to LABA or LAMA (random group B1) with respect to mean trough FEV1 after 12 weeks of treatment.~Ha: μFEV1, NVA237 - μFEV1, LABA and/or LAMA ≥ -40 mL"|||||<|0.0001|||||||linear mixed model|||||||<0.0001
72440758|NCT01985334|144394623|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||linear mixed model|||||||<0.0001
72440759|NCT01985334|144394624|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||linear mixed model|||||||<0.0001
72440760|NCT01985334|144394625|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||linear mixed model|||||||<0.0001
72440761|NCT01985334|144394626|NON_INFERIORITY_OR_EQUIVALENCE|A difference of 0.6 points in TDI was adopted as boundary for non-inferiority|||||<|0.0001|||||||linear mixed model|||||||<0.0001
72440762|NCT01985334|144394627|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||linear mixed model|||||||<0.0001
72496036|NCT00874250|144521717|SUPERIORITY_OR_OTHER||Proportion|0.98||||0.0024|TWO_SIDED|95.0|0.895|0.996|||Binomial Test|||||0.996|0.895|0.0024
72559181|NCT01634139|144648080|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.131|STANDARD_ERROR_OF_MEAN|0.066||0.0464|TWO_SIDED|95.0|-0.26|-0.002|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 48||-0.002|-0.260|0.0464
72559182|NCT01634139|144648081|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.096|STANDARD_ERROR_OF_MEAN|0.062||0.1182|TWO_SIDED|95.0|-0.217|0.025|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 24||0.025|-0.217|0.1182
72559183|NCT01634139|144648081|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.126|STANDARD_ERROR_OF_MEAN|0.061||0.0404|TWO_SIDED|95.0|-0.246|-0.006|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 24||-0.006|-0.246|0.0404
72619007|NCT00604383|144768412|SUPERIORITY_OR_OTHER|||||||0.034|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.034
72440763|NCT01985334|144394628|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||linear mixed model|||||||<0.0001
72440764|NCT00914589|144394637|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.0482||||0.8648||95.0|0.6095|1.8029||P values less than 0.05 are considered statistically significant in this study.|Regression, Logistic|||||1.8029|0.6095|0.8648
72440765|NCT00914589|144394637|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.9871||||0.9634||95.0|0.5673|1.7176||P values less than 0.05 are considered statistically significant in this study.|Regression, Logistic|||||1.7176|0.5673|0.9634
72440766|NCT01290341|144394642|SUPERIORITY_OR_OTHER||p-value|0.001|||<|0.025||95.0|||||Cochran-Mantel-Haenszel|The CMH test statistic after stratification by site was used to compare subjects with complete cure between NAFT-600 and Placebo.||"In order to compare complete cure rate in the NAFT-600 group with that of the Placebo group, the following one-sided hypothesis test was carried out:~H0 (null): p1\<=p0 versus Ha (alternate): p1\>p0, where p0 and p1 are the proportions of subjects with complete cure in the placebo and NAFT-600 treatment groups respectively."||||<0.025
72440767|NCT01102231|144394654|OTHER||Proportion difference|0.905|||||TWO_SIDED|95.0|0.846|0.964||||||||0.964|0.846|
72440768|NCT03903822|144394657|SUPERIORITY||Least square (LS) mean difference|-13.9|STANDARD_ERROR_OF_MEAN|11.04||0.104|TWO_SIDED|90.0|-32.1|4.3|||ANCOVA|||Analysis of covariance (ANCOVA) contained fixed factors of treatment and baseline value.||4.3|-32.1|0.1040
72440769|NCT03903822|144394657|SUPERIORITY||LS Mean Difference|-20.2|STANDARD_ERROR_OF_MEAN|11.0||0.0334|TWO_SIDED|90.0|-38.3|-2.1|||ANCOVA|||ANCOVA contained fixed factors of treatment and baseline value.||-2.1|-38.3|0.0334
72440770|NCT03903822|144394657|SUPERIORITY||LS Mean Difference|-25.6|STANDARD_ERROR_OF_MEAN|10.75||0.0086|TWO_SIDED|90.0|-43.3|-8.0|||ANCOVA|||ANCOVA contained fixed factors of treatment and baseline value.||-8.0|-43.3|0.0086
72440771|NCT03903822|144394657|SUPERIORITY||LS Mean Difference|-23.5|STANDARD_ERROR_OF_MEAN|10.93||0.0158|TWO_SIDED|90.0|-41.5|-5.5|||ANCOVA|||ANCOVA contained fixed factors of treatment and baseline value.||-5.5|-41.5|0.0158
72440772|NCT03903822|144394657|SUPERIORITY||LS Mean Difference|-11.0|STANDARD_ERROR_OF_MEAN|8.11||0.0879|TWO_SIDED|90.0|-24.3|2.4|||ANCOVA|||ANCOVA contained fixed factors of treatment and baseline value.||2.4|-24.3|0.0879
72440773|NCT03903822|144394657|SUPERIORITY||LS Mean Difference|-27.4|STANDARD_ERROR_OF_MEAN|8.11||0.0004|TWO_SIDED|90.0|-40.7|-14.1|||ANCOVA|||ANCOVA contained fixed factors of treatment and baseline value.||-14.1|-40.7|0.0004
72440774|NCT03903822|144394658|SUPERIORITY||Risk Difference (RD)|18.9||||0.0244|TWO_SIDED|90.0|2.4|34.7|||Chan and Zhang Exact Method|||Risk difference = difference in percentage of participants.||34.7|2.4|0.0244
72440775|NCT03903822|144394658|SUPERIORITY||Risk Difference (RD)|22.5||||0.0113|TWO_SIDED|90.0|4.8|38.6|||Chan and Zhang Exact Method|||Risk difference = difference in percentage of participants.||38.6|4.8|0.0113
72440776|NCT03903822|144394658|SUPERIORITY||Risk Difference (RD)|29.7||||0.0018|TWO_SIDED|90.0|11.0|45.7|||Chan and Zhang Exact Method|||Risk difference = difference in percentage of participants.||45.7|11.0|0.0018
72440777|NCT03903822|144394658|SUPERIORITY||Risk Difference (RD)|33.6||||0.0007|TWO_SIDED|90.0|13.7|49.9|||Chan and Zhang Exact Method|||Risk difference = difference in percentage of participants.||49.9|13.7|0.0007
72440778|NCT03903822|144394658|SUPERIORITY||Risk Difference (RD)|19.4||||0.0289|TWO_SIDED|90.0|1.8|36.5|||Chan and Zhang Exact Method|||Risk difference = difference in percentage of participants.||36.5|1.8|0.0289
72440779|NCT03903822|144394658|SUPERIORITY||Risk Difference (RD)|13.1||||0.1145|TWO_SIDED|90.0|-2.9|29.6|||Chan and Zhang Exact Method|||Risk difference = difference in percentage of participants.||29.6|-2.9|0.1145
72440780|NCT03903822|144394659|SUPERIORITY||LS mean difference|-1.31|STANDARD_ERROR_OF_MEAN|0.79||0.0488|TWO_SIDED|90.0|-2.61|-0.01|||ANCOVA|||ANCOVA contained fixed factors of treatment and baseline value.||-0.01|-2.61|0.0488
72440781|NCT03903822|144394659|SUPERIORITY||LS Mean Difference|-1.37|STANDARD_ERROR_OF_MEAN|0.788||0.0413|TWO_SIDED|90.0|-2.66|-0.07|||ANCOVA|||ANCOVA contained fixed factors of treatment and baseline value.||-0.07|-2.66|0.0413
72440782|NCT03903822|144394659|SUPERIORITY||LS Mean Difference|-1.59|STANDARD_ERROR_OF_MEAN|0.773||0.02|TWO_SIDED|90.0|-2.86|-0.32|||ANCOVA|||ANCOVA contained fixed factors of treatment and baseline value.||-0.32|-2.86|0.0200
72440783|NCT03903822|144394659|SUPERIORITY||LS Mean Difference|-2.33|STANDARD_ERROR_OF_MEAN|0.758||0.0011|TWO_SIDED|90.0|-3.58|-1.08|||ANCOVA|||ANCOVA contained fixed factors of treatment and baseline value.||-1.08|-3.58|0.0011
72440784|NCT03903822|144394659|SUPERIORITY||LS Mean Difference|-0.78|STANDARD_ERROR_OF_MEAN|0.535||0.0727|TWO_SIDED|90.0|-1.66|0.1|||ANCOVA|||ANCOVA contained fixed factors of treatment and baseline value.||0.10|-1.66|0.0727
72440785|NCT03903822|144394659|SUPERIORITY||LS Mean Difference|-1.64|STANDARD_ERROR_OF_MEAN|0.534||0.001|TWO_SIDED|90.0|-2.52|-0.77|||ANCOVA|||ANCOVA contained fixed factors of treatment and baseline value.||-0.77|-2.52|0.0010
72440786|NCT03903822|144394660|SUPERIORITY||Risk Difference (RD)|0.5||||0.5246|TWO_SIDED|90.0|-14.7|16.4|||Chan and Zhang Exact Method|||At Week 1: Risk difference = difference in percentage of participants.||16.4|-14.7|0.5246
72440787|NCT03903822|144394660|SUPERIORITY||Risk Difference (RD)|3.8||||0.3906|TWO_SIDED|90.0|-12.5|19.9|||Chan and Zhang Exact Method|||At Week 1: Risk difference = difference in percentage of participants.||19.9|-12.5|0.3906
72440788|NCT03903822|144394660|SUPERIORITY||Risk Difference (RD)|13.5||||0.1193|TWO_SIDED|90.0|-3.2|30.6|||Chan and Zhang Exact Method|||At Week 1: Risk difference = difference in percentage of participants.||30.6|-3.2|0.1193
72440789|NCT03903822|144394660|SUPERIORITY||Risk Difference (RD)|28.2||||0.0048|TWO_SIDED|90.0|8.8|45.5|||Chan and Zhang Exact Method|||At Week 1: Risk difference = difference in percentage of participants.||45.5|8.8|0.0048
72440790|NCT03903822|144394660|SUPERIORITY||Risk Difference (RD)|14.7||||0.0777|TWO_SIDED|90.0|-2.0|31.1|||Chan and Zhang Exact Method|||At Week 1: Risk difference = difference in percentage of participants.||31.1|-2.0|0.0777
72440791|NCT03903822|144394660|SUPERIORITY||Risk Difference (RD)|11.8||||0.1245|TWO_SIDED|90.0|-4.3|28.0|||Chan and Zhang Exact Method|||At Week 1: Risk difference = difference in percentage of participants.||28.0|-4.3|0.1245
72440792|NCT03903822|144394660|SUPERIORITY||Risk Difference (RD)|6.2||||0.3322|TWO_SIDED|90.0|-12.2|24.4|||Chan and Zhang Exact Method|||At Week 2: Risk difference = difference in percentage of participants.||24.4|-12.2|0.3322
72440793|NCT03903822|144394660|SUPERIORITY||Risk Difference (RD)|18.5||||0.0535|TWO_SIDED|90.0|-0.3|36.5|||Chan and Zhang Exact Method|||At Week 2: Risk difference = difference in percentage of participants.||36.5|-0.3|0.0535
72440794|NCT03903822|144394660|SUPERIORITY||Risk Difference (RD)|24.3||||0.0159|TWO_SIDED|90.0|4.5|41.9|||Chan and Zhang Exact Method|||At Week 2: Risk difference = difference in percentage of participants.||41.9|4.5|0.0159
72440795|NCT03903822|144394660|SUPERIORITY||Risk Difference (RD)|36.8||||0.0008|TWO_SIDED|90.0|15.4|54.0|||Chan and Zhang Exact Method|||At Week 2: Risk difference = difference in percentage of participants.||54.0|15.4|0.0008
72440796|NCT03903822|144394660|SUPERIORITY||Risk Difference (RD)|20.7||||0.0386|TWO_SIDED|90.0|1.5|38.8|||Chan and Zhang Exact Method|||At Week 2: Risk difference = difference in percentage of participants.||38.8|1.5|0.0386
72440797|NCT03903822|144394660|SUPERIORITY||Risk Difference (RD)|12.1||||0.1485|TWO_SIDED|90.0|-6.4|30.3|||Chan and Zhang Exact Method|||At Week 2: Risk difference = difference in percentage of participants.||30.3|-6.4|0.1485
72440798|NCT03903822|144394660|SUPERIORITY||Risk Difference (RD)|17.3||||0.062|TWO_SIDED|90.0|-0.8|34.8|||Chan and Zhang Exact Method|||At Week 3: Risk difference = difference in percentage of participants.||34.8|-0.8|0.0620
72440799|NCT03903822|144394660|SUPERIORITY||Risk Difference (RD)|26.9||||0.0089|TWO_SIDED|90.0|6.5|44.4|||Chan and Zhang Exact Method|||At Week 3: Risk difference = difference in percentage of participants.||44.4|6.5|0.0089
72440800|NCT03903822|144394660|SUPERIORITY||Risk Difference (RD)|37.8||||0.0005|TWO_SIDED|90.0|17.5|54.7|||Chan and Zhang Exact Method|||At Week 3: Risk difference = difference in percentage of participants.||54.7|17.5|0.0005
72440801|NCT03903822|144394660|SUPERIORITY||Risk Difference (RD)|36.7||||0.0007|TWO_SIDED|90.0|15.4|54.0|||Chan and Zhang Exact Method|||At Week 3: Risk difference = difference in percentage of participants.||54.0|15.4|0.0007
72440802|NCT03903822|144394660|SUPERIORITY||Risk Difference (RD)|18.1||||0.0711|TWO_SIDED|90.0|-2.0|37.5|||Chan and Zhang Exact Method|||At Week 3: Risk difference = difference in percentage of participants.||37.5|-2.0|0.0711
72440803|NCT03903822|144394660|SUPERIORITY||Risk Difference (RD)|23.8||||0.0266|TWO_SIDED|90.0|2.7|42.5|||Chan and Zhang Exact Method|||At Week 3: Risk difference = difference in percentage of participants.||42.5|2.7|0.0266
72440804|NCT03903822|144394660|SUPERIORITY||Risk Difference (RD)|3.8||||0.4173|TWO_SIDED|90.0|-15.3|23.1|||Chan and Zhang Exact Method|||At week 4: Risk difference = difference in percentage of participants.||23.1|-15.3|0.4173
72440805|NCT03903822|144394660|SUPERIORITY||Risk Difference (RD)|16.3||||0.1096|TWO_SIDED|90.0|-4.3|35.6|||Chan and Zhang Exact Method|||At Week 4: Risk difference = difference in percentage of participants.||35.6|-4.3|0.1096
72440806|NCT03903822|144394660|SUPERIORITY||Risk Difference (RD)|27.0||||0.0133|TWO_SIDED|90.0|6.1|45.7|||Chan and Zhang Exact Method|||At Week 4: Risk difference = difference in percentage of participants.||45.7|6.1|0.0133
72440807|NCT03903822|144394660|SUPERIORITY||Risk Difference (RD)|23.2||||0.0304|TWO_SIDED|90.0|2.6|41.7|||Chan and Zhang Exact Method|||At Week 4: Risk difference = difference in percentage of participants.||41.7|2.6|0.0304
72440808|NCT03903822|144394660|SUPERIORITY||Risk Difference (RD)|29.4||||0.0078|TWO_SIDED|90.0|7.2|47.6|||Chan and Zhang Exact Method|||At Week 4: Risk difference = difference in percentage of participants.||47.6|7.2|0.0078
72440809|NCT03903822|144394660|SUPERIORITY||Risk Difference (RD)|29.4||||0.0078|TWO_SIDED|90.0|7.2|47.6|||Chan and Zhang Exact Method|||At Week 4: Risk difference = difference in percentage of participants.||47.6|7.2|0.0078
72440810|NCT03903822|144394660|SUPERIORITY||Risk Difference (RD)|1.1||||0.4966|TWO_SIDED|90.0|-18.4|20.4|||Chan and Zhang Exact Method|||At Week 6: Risk difference = difference in percentage of participants.||20.4|-18.4|0.4966
72559184|NCT01634139|144648081|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.099|STANDARD_ERROR_OF_MEAN|0.062||0.1105|TWO_SIDED|95.0|-0.221|0.023|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 48||0.023|-0.221|0.1105
72440811|NCT03903822|144394660|SUPERIORITY||Risk Difference (RD)|10.9||||0.2753|TWO_SIDED|90.0|-9.3|30.1|||Chan and Zhang Exact Method|||At Week 6: Risk difference = difference in percentage of participants.||30.1|-9.3|0.2753
72440812|NCT03903822|144394660|SUPERIORITY||Risk Difference (RD)|16.2||||0.1036|TWO_SIDED|90.0|-4.2|35.7|||Chan and Zhang Exact Method|||At Week 6: Risk difference = difference in percentage of participants.||35.7|-4.2|0.1036
72440813|NCT03903822|144394660|SUPERIORITY||Risk Difference (RD)|20.6||||0.0457|TWO_SIDED|90.0|0.4|39.6|||Chan and Zhang Exact Method|||At Week 6: Risk difference = difference in percentage of participants.||39.6|0.4|0.0457
72440814|NCT03903822|144394660|SUPERIORITY||Risk Difference (RD)|29.4||||0.0078|TWO_SIDED|90.0|7.2|47.6|||Chan and Zhang Exact Method|||At Week 6: Risk difference = difference in percentage of participants.||47.6|7.2|0.0078
72440815|NCT03903822|144394660|SUPERIORITY||Risk Difference (RD)|29.4||||0.0078|TWO_SIDED|90.0|7.2|47.6|||Chan and Zhang Exact Method|||At Week 6: Risk difference = difference in percentage of participants.||47.6|7.2|0.0078
72440816|NCT03903822|144394661|SUPERIORITY||Risk Difference (RD)|3.3||||0.245|TWO_SIDED|90.0|-5.4|14.9|||Chan and Zhang Exact Method|||At Week 1: Risk difference = difference in percentage of participants.||14.9|-5.4|0.2450
72559185|NCT01634139|144648081|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.103|STANDARD_ERROR_OF_MEAN|0.062||0.0983|TWO_SIDED|95.0|-0.224|0.019|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 48||0.019|-0.224|0.0983
72559186|NCT01634139|144648082|SUPERIORITY_OR_OTHER||Mean Difference (Net)|8.507|STANDARD_ERROR_OF_MEAN|5.387||0.1146|TWO_SIDED|95.0|-2.063|19.077|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 24||19.077|-2.063|0.1146
72440817|NCT03903822|144394661|SUPERIORITY||Risk Difference (RD)|3.1||||0.2575|TWO_SIDED|90.0|-5.3|14.0|||Chan and Zhang Exact Method|||At Week 1: Risk difference = difference in percentage of participants.||14.0|-5.3|0.2575
72440818|NCT03903822|144394661|SUPERIORITY||Risk Difference (RD)|16.1||||0.0087|TWO_SIDED|90.0|5.7|31.0|||Chan and Zhang Exact Method|||At Week 1: Risk difference = difference in percentage of participants.||31.0|5.7|0.0087
72440819|NCT03903822|144394661|SUPERIORITY||Risk Difference (RD)|10.7||||0.0392|TWO_SIDED|90.0|0.8|25.4|||Chan and Zhang Exact Method|||At Week 1: Risk difference = difference in percentage of participants.||25.4|0.8|0.0392
72440820|NCT03903822|144394661|SUPERIORITY||Risk Difference (RD)|0.0||||1|TWO_SIDED|90.0|-11.2|11.2|||Chan and Zhang Exact Method|||At Week 1: Risk difference = difference in percentage of participants.||11.2|-11.2|1.0000
72440821|NCT03903822|144394661|SUPERIORITY||Risk Difference (RD)|7.8||||0.1528|TWO_SIDED|90.0|-4.9|22.5|||Chan and Zhang Exact Method|||At Week 1: Risk difference = difference in percentage of participants.||22.5|-4.9|0.1528
72440822|NCT03903822|144394661|SUPERIORITY||Risk Difference (RD)|0.9||||0.4989|TWO_SIDED|90.0|-12.7|15.2|||Chan and Zhang Exact Method|||At Week 2: Risk difference = difference in percentage of participants.||15.2|-12.7|0.4989
72440823|NCT03903822|144394661|SUPERIORITY||Risk Difference (RD)|0.3||||0.5419|TWO_SIDED|90.0|-13.6|14.2|||Chan and Zhang Exact Method|||At Week 2: Risk difference = difference in percentage of participants.||14.2|-13.6|0.5419
72440824|NCT03903822|144394661|SUPERIORITY||Risk Difference (RD)|10.3||||0.1362|TWO_SIDED|90.0|-5.0|26.2|||Chan and Zhang Exact Method|||At Week 2: Risk difference = difference in percentage of participants.||26.2|-5.0|0.1362
72440825|NCT03903822|144394661|SUPERIORITY||Risk Difference (RD)|15.9||||0.0541|TWO_SIDED|90.0|-0.4|33.9|||Chan and Zhang Exact Method|||At Week 2: Risk difference = difference in percentage of participants.||33.9|-0.4|0.0541
72440826|NCT03903822|144394661|SUPERIORITY||Risk Difference (RD)|3.3||||0.3945|TWO_SIDED|90.0|-12.0|19.5|||Chan and Zhang Exact Method|||At Week 2: Risk difference = difference in percentage of participants.||19.5|-12.0|0.3945
72440827|NCT03903822|144394661|SUPERIORITY||Risk Difference (RD)|23.3||||0.0201|TWO_SIDED|90.0|3.9|41.8|||Chan and Zhang Exact Method|||At Week 2: Risk difference = difference in percentage of participants.||41.8|3.9|0.0201
72440828|NCT03903822|144394661|SUPERIORITY||Risk Difference (RD)|11.2||||0.1372|TWO_SIDED|90.0|-5.4|28.2|||Chan and Zhang Exact Method|||At Week 3: Risk difference = difference in percentage of participants.||28.2|-5.4|0.1372
72440829|NCT03903822|144394661|SUPERIORITY||Risk Difference (RD)|3.5||||0.3924|TWO_SIDED|90.0|-11.6|19.1|||Chan and Zhang Exact Method|||At Week 3: Risk difference = difference in percentage of participants.||19.1|-11.6|0.3924
72440830|NCT03903822|144394661|SUPERIORITY||Risk Difference (RD)|20.1||||0.0311|TWO_SIDED|90.0|2.4|38.3|||Chan and Zhang Exact Method|||At Week 3: Risk difference = difference in percentage of participants.||38.3|2.4|0.0311
72440831|NCT03903822|144394661|SUPERIORITY||Risk Difference (RD)|20.0||||0.0392|TWO_SIDED|90.0|0.8|38.1|||Chan and Zhang Exact Method|||At Week 3: Risk difference = difference in percentage of participants.||38.1|0.8|0.0392
72440832|NCT03903822|144394661|SUPERIORITY||Risk Difference (RD)|10.0||||0.1541|TWO_SIDED|90.0|-6.2|26.4|||Chan and Zhang Exact Method|||At Week 3: Risk difference = difference in percentage of participants.||26.4|-6.2|0.1541
72440833|NCT03903822|144394661|SUPERIORITY||Risk Difference (RD)|27.0||||0.0091|TWO_SIDED|90.0|6.8|45.4|||Chan and Zhang Exact Method|||At Week 3: Risk difference = difference in percentage of participants.||45.4|6.8|0.0091
72619008|NCT01122680|144768418|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.113|STANDARD_ERROR_OF_MEAN|0.039||0.0043||95.0|0.036|0.19||First step of closed testing procedure, where the active treatments are compared to placebo. If this statisical test significant at the 0.05 alpha level then proceed to comparison of the next lower dose to placebo.|Mixed model repeated measures (MMRM)|This MMRM model includes treatment, period and baseline as fixed effects, and patient as a random effect.||Tio R5 minus Placebo||0.190|0.036|0.0043
72440834|NCT03903822|144394661|SUPERIORITY||Risk Difference (RD)|8.5||||0.2835|TWO_SIDED|90.0|-9.5|27.0|||Chan and Zhang Exact Method|||At Week 4: Risk difference = difference in percentage of participants.||27.0|-9.5|0.2835
72440835|NCT03903822|144394661|SUPERIORITY||Risk Difference (RD)|9.9||||0.27|TWO_SIDED|90.0|-8.7|27.8|||Chan and Zhang Exact Method|||At Week 4: Risk difference = difference in percentage of participants.||27.8|-8.7|0.2700
72440836|NCT03903822|144394661|SUPERIORITY||Risk Difference (RD)|17.3||||0.0662|TWO_SIDED|90.0|-1.4|36.2|||Chan and Zhang Exact Method|||At Week 4: Risk difference = difference in percentage of participants.||36.2|-1.4|0.0662
72440837|NCT03903822|144394661|SUPERIORITY||Risk Difference (RD)|31.8||||0.005|TWO_SIDED|90.0|9.2|50.4|||Chan and Zhang Exact Method|||At Week 4: Risk difference = difference in percentage of participants.||50.4|9.2|0.0050
72440838|NCT03903822|144394661|SUPERIORITY||Risk Difference (RD)|20.0||||0.0302|TWO_SIDED|90.0|2.2|38.3|||Chan and Zhang Exact Method|||At Week 4: Risk difference = difference in percentage of participants.||38.3|2.2|0.0302
72440839|NCT03903822|144394661|SUPERIORITY||Risk Difference (RD)|27.0||||0.0091|TWO_SIDED|90.0|6.8|45.4|||Chan and Zhang Exact Method|||At Week 4: Risk difference = difference in percentage of participants.||45.4|6.8|0.0091
72440840|NCT03903822|144394661|SUPERIORITY||Risk Difference (RD)|11.8||||0.1561|TWO_SIDED|90.0|-6.5|30.2|||Chan and Zhang Exact Method|||At Week 6: Risk difference = difference in percentage of participants.||30.2|-6.5|0.1561
72440841|NCT03903822|144394661|SUPERIORITY||Risk Difference (RD)|16.2||||0.0753|TWO_SIDED|90.0|-2.7|34.8|||Chan and Zhang Exact Method|||At Week 6: Risk difference = difference in percentage of participants.||34.8|-2.7|0.0753
72440842|NCT03903822|144394661|SUPERIORITY||Risk Difference (RD)|27.0||||0.0108|TWO_SIDED|90.0|5.7|46.0|||Chan and Zhang Exact Method|||At Week 6: Risk difference = difference in percentage of participants.||46.0|5.7|0.0108
72440843|NCT03903822|144394661|SUPERIORITY||Risk Difference (RD)|31.8||||0.005|TWO_SIDED|90.0|9.2|50.4|||Chan and Zhang Exact Method|||At Week 6: Risk difference = difference in percentage of participants.||50.4|9.2|0.0050
72440844|NCT03903822|144394661|SUPERIORITY||Risk Difference (RD)|16.7||||0.0775|TWO_SIDED|90.0|-2.9|35.7|||Chan and Zhang Exact Method|||At Week 6: Risk difference = difference in percentage of participants.||35.7|-2.9|0.0775
72440845|NCT03903822|144394661|SUPERIORITY||Risk Difference (RD)|24.1||||0.0243|TWO_SIDED|90.0|3.4|43.4|||Chan and Zhang Exact Method|||At Week 6: Risk difference = difference in percentage of participants.||43.4|3.4|0.0243
72440846|NCT03903822|144394661|SUPERIORITY||Risk Difference (RD)|20.9||||0.0234|TWO_SIDED|90.0|3.5|38.8|||Chan and Zhang Exact Method|||At follow-up visit: Risk difference = difference in percentage of participants.||38.8|3.5|0.0234
72440847|NCT03903822|144394661|SUPERIORITY||Risk Difference (RD)|12.8||||0.1134|TWO_SIDED|90.0|-2.8|29.3|||Chan and Zhang Exact Method|||At follow-up visit: Risk difference = difference in percentage of participants.||29.3|-2.8|0.1134
72440848|NCT03903822|144394661|SUPERIORITY||Risk Difference (RD)|10.3||||0.1362|TWO_SIDED|90.0|-5.0|26.2|||Chan and Zhang Exact Method|||At follow-up visit: Risk difference = difference in percentage of participants.||26.2|-5.0|0.1362
72440849|NCT03903822|144394661|SUPERIORITY||Risk Difference (RD)|12.3||||0.1029|TWO_SIDED|90.0|-3.4|29.8|||Chan and Zhang Exact Method|||At follow-up visit: Risk difference = difference in percentage of participants.||29.8|-3.4|0.1029
72440850|NCT03903822|144394661|SUPERIORITY||Risk Difference (RD)|0.0||||1|TWO_SIDED|90.0|-17.9|17.9|||Chan and Zhang Exact Method|||At follow-up visit: Risk difference = difference in percentage of participants.||17.9|-17.9|1.0000
72440851|NCT03903822|144394661|SUPERIORITY||Risk Difference (RD)|-12.6||||0.8972|TWO_SIDED|90.0|-28.8|3.5|||Chan and Zhang Exact Method|||At follow-up visit: Risk difference = difference in percentage of participants.||3.5|-28.8|0.8972
72440852|NCT03903822|144394662|SUPERIORITY||LS Mean difference|-0.5|STANDARD_ERROR_OF_MEAN|8.33||0.4781|TWO_SIDED|90.0|-14.2|13.3|||Mixed Model Repeated Measure|||At Week 1: Mixed Model Repeated Measure (MMRM) contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.||13.3|-14.2|0.4781
72440853|NCT03903822|144394662|SUPERIORITY||LS Mean difference|-13.8|STANDARD_ERROR_OF_MEAN|8.47||0.0522|TWO_SIDED|90.0|-27.8|0.2|||Mixed Model Repeated Measure|||At Week 1: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.||0.2|-27.8|0.0522
72440854|NCT03903822|144394662|SUPERIORITY||LS Mean difference|-17.5|STANDARD_ERROR_OF_MEAN|8.37||0.0187|TWO_SIDED|90.0|-31.4|-3.7|||Mixed Model Repeated Measure|||At Week 1: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.||-3.7|-31.4|0.0187
72440855|NCT03903822|144394662|SUPERIORITY||LS Mean difference|-20.6|STANDARD_ERROR_OF_MEAN|8.45||0.008|TWO_SIDED|90.0|-34.5|-6.6|||Mixed Model Repeated Measure|||At Week 1: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.||-6.6|-34.5|0.0080
72440856|NCT03903822|144394662|SUPERIORITY||LS Mean difference|-25.0|STANDARD_ERROR_OF_MEAN|14.17||0.0401|TWO_SIDED|90.0|-48.6|-1.5|||Mixed Model Repeated Measure|||At Week 1: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.||-1.5|-48.6|0.0401
72440857|NCT03903822|144394662|SUPERIORITY||LS Mean difference|-25.5|STANDARD_ERROR_OF_MEAN|14.25||0.0379|TWO_SIDED|90.0|-49.2|-1.9|||Mixed Model Repeated Measure|||At Week 1: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.||-1.9|-49.2|0.0379
72440858|NCT03903822|144394662|SUPERIORITY||LS Mean difference|8.1|STANDARD_ERROR_OF_MEAN|11.01||0.7678|TWO_SIDED|90.0|-10.1|26.3|||Mixed Model Repeated Measure|||At Week 2: MMRM contained fixed factors of treatment, visit(Weeks 1, 2, 3, 4, 6 and follow up), treatment-by-visit interaction and baseline value.||26.3|-10.1|0.7678
72440859|NCT03903822|144394662|SUPERIORITY||LS Mean difference|-22.8|STANDARD_ERROR_OF_MEAN|10.94||0.0193|TWO_SIDED|90.0|-40.9|-4.7|||Mixed Model Repeated Measure|||At Week 2: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.||-4.7|-40.9|0.0193
72440860|NCT03903822|144394662|SUPERIORITY||LS Mean difference|-28.3|STANDARD_ERROR_OF_MEAN|10.95||0.0052|TWO_SIDED|90.0|-46.5|-10.2|||Mixed Model Repeated Measure|||At Week 2:MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.||-10.2|-46.5|0.0052
72440861|NCT03903822|144394662|SUPERIORITY||LS Mean difference|-23.7|STANDARD_ERROR_OF_MEAN|11.03||0.0164|TWO_SIDED|90.0|-42.0|-5.5|||Mixed Model Repeated Measure|||At Week 2: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.||-5.5|-42.0|0.0164
72440862|NCT03903822|144394662|SUPERIORITY||LS Mean difference|-31.7|STANDARD_ERROR_OF_MEAN|9.72||0.0008|TWO_SIDED|90.0|-47.8|-15.6|||Mixed Model Repeated Measure|||At Week 2: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.||-15.6|-47.8|0.0008
72440863|NCT03903822|144394662|SUPERIORITY||LS Mean difference|-40.6|STANDARD_ERROR_OF_MEAN|9.86|<|0.0001|TWO_SIDED|90.0|-57.0|-24.3|||Mixed Model Repeated Measure|||At Week 2: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.||-24.3|-57.0|<0.0001
72440864|NCT03903822|144394662|SUPERIORITY||LS Mean difference|3.9|STANDARD_ERROR_OF_MEAN|12.09||0.6269|TWO_SIDED|90.0|-16.1|23.9|||Mixed Model Repeated Measure|||At Week 3: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.||23.9|-16.1|0.6269
72619009|NCT01122680|144768418|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.057|STANDARD_ERROR_OF_MEAN|0.039||0.1484||95.0|-0.021|0.135||Second step of closed testing procedure. If this statisical test significant at the 0.05 alpha level then proceed to comparison of the next lower dose to placebo.|Mixed effect repeated measures (MMRM)|This MMRM model includes treatment, period and baseline as fixed effects, and patient as a random effect.||Tio R2.5 minus Placebo||0.135|-0.021|0.1484
72440865|NCT03903822|144394662|SUPERIORITY||LS Mean difference|-33.5|STANDARD_ERROR_OF_MEAN|11.87||0.0027|TWO_SIDED|90.0|-53.1|-13.8|||Mixed Model Repeated Measure|||At Week 3: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.||-13.8|-53.1|0.0027
72440866|NCT03903822|144394662|SUPERIORITY||LS Mean difference|-38.8|STANDARD_ERROR_OF_MEAN|11.89||0.0007|TWO_SIDED|90.0|-58.5|-19.2|||Mixed Model Repeated Measure|||At Week 3: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.||-19.2|-58.5|0.0007
72440867|NCT03903822|144394662|SUPERIORITY||LS Mean difference|-32.1|STANDARD_ERROR_OF_MEAN|12.0||0.0041|TWO_SIDED|90.0|-51.9|-12.3|||Mixed Model Repeated Measure|||At Week 3: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.||-12.3|-51.9|0.0041
72440868|NCT03903822|144394662|SUPERIORITY||LS Mean difference|-14.6|STANDARD_ERROR_OF_MEAN|11.61||0.1054|TWO_SIDED|90.0|-33.9|4.6|||Mixed Model Repeated Measure|||At Week 3: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.||4.6|-33.9|0.1054
72440869|NCT03903822|144394662|SUPERIORITY||LS Mean difference|-18.8|STANDARD_ERROR_OF_MEAN|11.62||0.0542|TWO_SIDED|90.0|-38.1|0.5|||Mixed Model Repeated Measure|||At Week 3: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.||0.5|-38.1|0.0542
72504659|NCT02495077|144540086|SUPERIORITY||Mean Difference (Final Values)|-2.28||||0.328|TWO_SIDED|95.0|-6.86|2.31|||Mixed Models Analysis|||Day 180. Mean eGFR of the two treatment groups was compared. The p-value, estimated day 180 eGFR within each treatment group, estimate of the treatment group difference, and estimated 95% confidence interval result from a repeated measures mixed model using available eGFR data from months 1, 3, 6, 12, 18, and 24 to compare the experimental group to the control group at day 180. Random effects for the intercept and eGFR collection day were utilized in the model.||2.31|-6.86|0.328
72504660|NCT02495077|144540087|SUPERIORITY||Mean Difference (Final Values)|-0.85||||0.725|TWO_SIDED|95.0|-5.58|3.89|||Mixed Models Analysis|||Day 7. Mean eGFR of the two treatment groups was compared. The p-value, estimated day 7 eGFR within each treatment group, estimate of the treatment group difference, and estimated 95% confidence interval result from a repeated measures mixed model using available eGFR data from day 7 and months 1, 3, 6, 12, 18, and 24 to compare the experimental group to the control group at day 7. Random effects for the intercept and eGFR collection day were utilized in the model.||3.89|-5.58|0.725
72440870|NCT03903822|144394662|SUPERIORITY||LS Mean difference|5.8|STANDARD_ERROR_OF_MEAN|12.12||0.6847|TWO_SIDED|90.0|-14.2|25.9|||Mixed Model Repeated Measure|||At Week 4: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.||25.9|-14.2|0.6847
72440871|NCT03903822|144394662|SUPERIORITY||LS Mean difference|-29.9|STANDARD_ERROR_OF_MEAN|11.82||0.0062|TWO_SIDED|90.0|-49.4|-10.3|||Mixed Model Repeated Measure|||At Week 4: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.||-10.3|-49.4|0.0062
72440872|NCT03903822|144394662|SUPERIORITY||LS Mean difference|-32.0|STANDARD_ERROR_OF_MEAN|11.89||0.004|TWO_SIDED|90.0|-51.6|-12.3|||Mixed Model Repeated Measure|||At Week 4: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.||-12.3|-51.6|0.0040
72440873|NCT03903822|144394662|SUPERIORITY||LS Mean difference|-30.8|STANDARD_ERROR_OF_MEAN|11.97||0.0054|TWO_SIDED|90.0|-50.6|-11.0|||Mixed Model Repeated Measure|||At Week 4: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.||-11.0|-50.6|0.0054
72440874|NCT03903822|144394662|SUPERIORITY||LS Mean difference|-11.7|STANDARD_ERROR_OF_MEAN|9.35||0.1076|TWO_SIDED|90.0|-27.2|3.9|||Mixed Model Repeated Measure|||At Week 4: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.||3.9|-27.2|0.1076
72440875|NCT03903822|144394662|SUPERIORITY||LS Mean difference|-23.0|STANDARD_ERROR_OF_MEAN|9.42||0.0082|TWO_SIDED|90.0|-38.6|-7.3|||Mixed Model Repeated Measure|||At Week 4: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.||-7.3|-38.6|0.0082
72496037|NCT02986230|144521726|SUPERIORITY||Odds Ratio (OR)|1.07||||0.025|TWO_SIDED|||||Tests of the two planned contrasts were 2-sided with P-values less than 0.025 considered statistically significant, and odds ratios for key study group contrasts report 97.5% confidence intervals.|Mixed Models Analysis|Denominator degrees of freedom for variables in the model take into account the cluster-randomized design.||Generalized linear mixed models with logit link and binomial error distribution were used to test the effect of the intervention on the composite of cancer screening by 1 year post-index for breast, cervical, and colorectal cancer. The model included two primary contrasts: CP-CDS vs. UC and CP-CDS+SDMT vs. UC and included pre-specified covariates and variables used in the randomization process. Tests of the two contrasts were 2-sided with P-values \< 0.025 considered statistically significant.||||.025
72496038|NCT02986230|144521726|SUPERIORITY||Odds Ratio (OR)|0.91||||0.025|TWO_SIDED|||||Tests of the two planned contrasts were 2-sided with P-values less than 0.025 considered statistically significant, and odds ratios for key study group contrasts report 97.5% confidence intervals.|Mixed Models Analysis|Denominator degrees of freedom for variables in the model take into account the cluster-randomized design.||Generalized linear mixed models with a logit link and binomial error distribution were used to test the effect of the intervention on the composite of cancer screening by 1 year post-index date for breast, cervical, and colorectal cancer. Model included two primary contrasts: CP-CDS vs. UC and CP-CDS+SDMT vs. UC and included pre-specified covariates and variables used in randomization process. Tests of the planned contrasts were 2-sided with P-values \< 0.025 considered statistically significant.||||.025
72496039|NCT02986230|144521727|SUPERIORITY||Odds Ratio (OR)|1.04||||0.025|TWO_SIDED|||||Tests of the two planned contrasts were 2-sided with P-values less than 0.025 considered statistically significant, and odds ratios for key study group contrasts report 97.5% confidence intervals.|Mixed Models Analysis|Denominator degrees of freedom for variables in the model take into account the cluster-randomized design.||Generalized linear mixed models with a logit link and binomial error distribution were used to test the effect of the intervention on completion of the HPV vaccination series by 12 months post-index date. The model included two primary contrasts: CP-CDS vs. UC and CP-CDS+SDMT vs. UC and included pre-specified covariates and variables used in the randomization process. Tests of the two planned contrasts were 2-sided with P-values less than 0.025 considered statistically significant.||||.025
72496040|NCT02986230|144521727|SUPERIORITY||Odds Ratio (OR)|0.71||||0.025|TWO_SIDED|||||Tests of the two planned contrasts were 2-sided with P-values less than 0.025 considered statistically significant, and odds ratios for key study group contrasts report 97.5% confidence intervals.|Mixed Models Analysis|Denominator degrees of freedom for variables in the model take into account the cluster-randomized design.||Generalized linear mixed models with a logit link and binomial error distribution were used to test the effect of the intervention on completion of the HPV vaccination series by 12 months post-index date. The model included two primary contrasts: CP-CDS vs. UC and CP-CDS+SDMT vs. UC and included pre-specified covariates and variables used in the randomization process. Tests of the two planned contrasts were 2-sided with P-values less than 0.025 considered statistically significant.||||.025
72496041|NCT02986230|144521728|SUPERIORITY||Odds Ratio (OR)|1.55||||0.025|TWO_SIDED|||||Tests of the two planned contrasts were 2-sided with P-values less than 0.025 considered statistically significant, and odds ratios for key study group contrasts report 97.5% confidence intervals.|Mixed Models Analysis|Denominator degrees of freedom for variables in the model take into account the cluster-randomized design.||Generalized linear mixed models with a logit link and binomial error distribution were used to test the effect of the intervention on completion of lung cancer screening by 12 months post-index date. The model included two primary contrasts: CP-CDS vs. UC and CP-CDS+SDMT vs. UC and included pre-specified covariates and variables used in the randomization process. Tests of the two planned contrasts were 2-sided with P-values less than 0.025 considered statistically significant.||||.025
72496042|NCT02986230|144521728|SUPERIORITY||Odds Ratio (OR)|1.02||||0.025|TWO_SIDED|||||Tests of the two planned contrasts were 2-sided with P-values less than 0.025 considered statistically significant, and odds ratios for key study group contrasts report 97.5% confidence intervals.|Mixed Models Analysis|Denominator degrees of freedom for variables in the model take into account the cluster-randomized design.||Generalized linear mixed models with a logit link and binomial error distribution were used to test the intervention effect on the completion of lung cancer screening by 12 months post-index. The model included two primary contrasts: CP-CDS vs. UC and CP-CDS+SDMT vs. UC and included pre-specified covariates and variables used in the randomization process. Tests of the two planned contrasts were 2-sided with P-values less than 0.025 considered statistically significant.||||.025
72496043|NCT03550066|144521729|NON_INFERIORITY|The non-inferiority limit, d, is selected as the largest difference that is clinically acceptable. Here the non-inferiority limit is d=.6 (a medium to large effect size).||||||0.18||||||Threshold for statistical significance: \<.05|t-test, 2 sided|||||||0.18
72496044|NCT00654498|144521811|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.52|STANDARD_ERROR_OF_MEAN|1.05|<|0.0001|TWO_SIDED|95.0|-6.58|-2.46|||ANCOVA|ANCOVA with treatment and center as fixed factors and baseline as a covariate||||-2.46|-6.58|<0.0001
72496045|NCT00654498|144521812|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Cochran-Mantel-Haenszel|test stratified by centre||||||<0.0001
72496046|NCT00654498|144521813|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Cochran-Mantel-Haenszel|test stratified by centre||||||<0.0001
72496047|NCT00654498|144521814|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Cochran-Mantel-Haenszel|test stratified by centre||||||<0.0001
72496048|NCT00654498|144521815|SUPERIORITY_OR_OTHER|||||||0.1386||95.0|||||Chi-squared|||||||0.1386
72496049|NCT00654498|144521816|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.48|STANDARD_ERROR_OF_MEAN|0.33|<|0.0001|TWO_SIDED|95.0|-2.14|-0.83|||ANCOVA|ANCOVA with treatment and center as fixed factors and baseline as a covariate||||-0.83|-2.14|<0.0001
72496050|NCT00654498|144521817|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.36|STANDARD_ERROR_OF_MEAN|0.32|<|0.0001|TWO_SIDED|95.0|-1.99|-0.73|||ANCOVA|ANCOVA with treatment and center as fixed factors and baseline as a covariate||||-0.73|-1.99|<0.0001
72496051|NCT00654498|144521818|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.36|STANDARD_ERROR_OF_MEAN|0.33|<|0.0001|TWO_SIDED|95.0|-2.0|-0.72|||ANCOVA|ANCOVA with treatment and center as fixed factors and baseline as a covariate||||-0.72|-2.00|<0.0001
72496052|NCT00654498|144521819|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.54|STANDARD_ERROR_OF_MEAN|0.26||0.0402|TWO_SIDED|95.0|-1.06|-0.02|||ANCOVA|ANCOVA with treatment and center as fixed factors and baseline as a covariate||||-0.02|-1.06|0.0402
72559187|NCT01634139|144648082|SUPERIORITY_OR_OTHER||Mean Difference (Net)|7.493|STANDARD_ERROR_OF_MEAN|5.365||0.1628|TWO_SIDED|95.0|-3.034|18.02|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 24||18.020|-3.034|0.1628
72559188|NCT01634139|144648082|SUPERIORITY_OR_OTHER||Mean Difference (Net)|5.538|STANDARD_ERROR_OF_MEAN|5.435||0.3085|TWO_SIDED|95.0|-5.127|16.203|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 48||16.203|-5.127|0.3085
72559189|NCT01634139|144648082|SUPERIORITY_OR_OTHER||Mean Difference (Net)|8.774|STANDARD_ERROR_OF_MEAN|5.413||0.1053|TWO_SIDED|95.0|-1.847|19.394|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 48||19.394|-1.847|0.1053
72559190|NCT01634139|144648083|SUPERIORITY_OR_OTHER||Mean Difference (Net)|12.36|STANDARD_ERROR_OF_MEAN|5.451||0.0236|TWO_SIDED|95.0|1.663|23.056|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 24||23.056|1.663|0.0236
72559191|NCT01634139|144648083|SUPERIORITY_OR_OTHER||Mean Difference (Net)|14.146|STANDARD_ERROR_OF_MEAN|5.427||0.0093|TWO_SIDED|95.0|3.497|24.794|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 24||24.794|3.497|0.0093
72559192|NCT01634139|144648083|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.882|STANDARD_ERROR_OF_MEAN|5.497||0.7322|TWO_SIDED|95.0|-12.667|8.904|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 48||8.904|-12.667|0.7322
72559193|NCT01634139|144648083|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.176|STANDARD_ERROR_OF_MEAN|5.481||0.4463|TWO_SIDED|95.0|-6.578|14.929|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 48||14.929|-6.578|0.4463
72440876|NCT03903822|144394662|SUPERIORITY||LS Mean difference|-17.8|STANDARD_ERROR_OF_MEAN|14.14||0.1051|TWO_SIDED|90.0|-41.2|5.6|||Mixed Model Repeated Measure|||At Week 6: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.||5.6|-41.2|0.1051
72440877|NCT03903822|144394662|SUPERIORITY||LS Mean difference|-37.8|STANDARD_ERROR_OF_MEAN|13.8||0.0034|TWO_SIDED|90.0|-60.6|-15.0|||Mixed Model Repeated Measure|||At Week 6: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.||-15.0|-60.6|0.0034
72440878|NCT03903822|144394662|SUPERIORITY||LS Mean difference|-41.9|STANDARD_ERROR_OF_MEAN|13.83||0.0014|TWO_SIDED|90.0|-64.8|-19.0|||Mixed Model Repeated Measure|||At Week 6: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.||-19.0|-64.8|0.0014
72559194|NCT01634139|144648084|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.262|STANDARD_ERROR_OF_MEAN|1.039||0.8008|TWO_SIDED|95.0|-1.775|2.299|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 24||2.299|-1.775|0.8008
72559195|NCT01634139|144648084|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.166|STANDARD_ERROR_OF_MEAN|1.041||0.8731|TWO_SIDED|95.0|-1.875|2.208|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 24||2.208|-1.875|0.8731
72559196|NCT01634139|144648084|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.272|STANDARD_ERROR_OF_MEAN|1.058||0.7975|TWO_SIDED|95.0|-1.803|2.346|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 48||2.346|-1.803|0.7975
72559197|NCT01634139|144648084|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.579|STANDARD_ERROR_OF_MEAN|1.059||0.5845|TWO_SIDED|95.0|-2.656|1.498|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 48||1.498|-2.656|0.5845
72559198|NCT01634139|144648085|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.019|STANDARD_ERROR_OF_MEAN|0.048||0.6932|TWO_SIDED|95.0|-0.075|0.113|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 24||0.113|-0.075|0.6932
72559199|NCT01634139|144648085|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.065|STANDARD_ERROR_OF_MEAN|0.048||0.1741|TWO_SIDED|95.0|-0.158|0.029|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 24||0.029|-0.158|0.1741
72559200|NCT01634139|144648085|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.024|STANDARD_ERROR_OF_MEAN|0.048||0.625|TWO_SIDED|95.0|-0.071|0.118|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 48||0.118|-0.071|0.6250
72559201|NCT01634139|144648085|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.015|STANDARD_ERROR_OF_MEAN|0.048||0.7597|TWO_SIDED|95.0|-0.109|0.08|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 48||0.080|-0.109|0.7597
72559202|NCT01634139|144648086|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.025|STANDARD_ERROR_OF_MEAN|0.05||0.6166|TWO_SIDED|95.0|-0.122|0.073|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 24||0.073|-0.122|0.6166
72619010|NCT01122680|144768418|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.067|STANDARD_ERROR_OF_MEAN|0.036||0.0664||95.0|-0.005|0.138||This test is considered as descriptive.|Mixed effect repeated measures (MMRM)|This MMRM model includes treatment, period and baseline as fixed effects, and patient as a random effect.||Tio R1.25 minus Placebo||0.138|-0.005|0.0664
72440879|NCT03903822|144394662|SUPERIORITY||LS Mean difference|-38.6|STANDARD_ERROR_OF_MEAN|13.9||0.003|TWO_SIDED|90.0|-61.6|-15.6|||Mixed Model Repeated Measure|||At Week 6: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.||-15.6|-61.6|0.0030
72440880|NCT03903822|144394662|SUPERIORITY||LS Mean difference|-17.7|STANDARD_ERROR_OF_MEAN|9.22||0.0289|TWO_SIDED|90.0|-33.0|-2.4|||Mixed Model Repeated Measure|||At Week 6: MMRM contained fixed factors of treatment, visit(Weeks 1, 2, 3, 4, 6 and follow up), treatment-by-visit interaction and baseline value.||-2.4|-33.0|0.0289
72559203|NCT01634139|144648086|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.076|STANDARD_ERROR_OF_MEAN|0.049||0.1267|TWO_SIDED|95.0|-0.173|0.021|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 24||0.021|-0.173|0.1267
72559204|NCT01634139|144648086|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.006|STANDARD_ERROR_OF_MEAN|0.05||0.9|TWO_SIDED|95.0|-0.092|0.105|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 48||0.105|-0.092|0.9000
72440881|NCT03903822|144394662|SUPERIORITY||LS Mean difference|-33.8|STANDARD_ERROR_OF_MEAN|9.27||0.0002|TWO_SIDED|90.0|-49.2|-18.4|||Mixed Model Repeated Measure|||At Week 6: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.||-18.4|-49.2|0.0002
72440882|NCT03903822|144394662|SUPERIORITY||LS Mean difference|-0.9|STANDARD_ERROR_OF_MEAN|13.88||0.4739|TWO_SIDED|90.0|-23.9|22.0|||Mixed Model Repeated Measure|||At follow-up visit: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.||22.0|-23.9|0.4739
72440883|NCT03903822|144394662|SUPERIORITY||LS Mean difference|-19.1|STANDARD_ERROR_OF_MEAN|13.43||0.0789|TWO_SIDED|90.0|-41.3|3.2|||Mixed Model Repeated Measure|||At follow-up visit: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.||3.2|-41.3|0.0789
72440884|NCT03903822|144394662|SUPERIORITY||LS Mean difference|-13.4|STANDARD_ERROR_OF_MEAN|13.5||0.1611|TWO_SIDED|90.0|-35.7|8.9|||Mixed Model Repeated Measure|||At follow-up visit: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.||8.9|-35.7|0.1611
72440885|NCT03903822|144394662|SUPERIORITY||LS Mean Difference|-31.6|STANDARD_ERROR_OF_MEAN|13.94||0.0124|TWO_SIDED|90.0|-54.7|-8.5|||Mixed Model Repeated Measure|||At follow-up visit: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.||-8.5|-54.7|0.0124
72440886|NCT03903822|144394662|SUPERIORITY||LS Mean difference|-5.3|STANDARD_ERROR_OF_MEAN|17.68||0.3828|TWO_SIDED|90.0|-34.7|24.1|||Mixed Model Repeated Measure|||At follow-up visit: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.||24.1|-34.7|0.3828
72440887|NCT03903822|144394662|SUPERIORITY||LS Mean difference|1.7|STANDARD_ERROR_OF_MEAN|17.8||0.5383|TWO_SIDED|90.0|-27.9|31.3|||Mixed Model Repeated Measure|||At follow-up visit: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.||31.3|-27.9|0.5383
72440888|NCT03903822|144394663|SUPERIORITY||Risk Difference (RD)|-5.4||||0.8964|TWO_SIDED|90.0|-16.1|2.0|||Chan and Zhang Exact Method|||At Week 1: Risk difference = difference in percentage of participants.||2.0|-16.1|0.8964
72440889|NCT03903822|144394663|SUPERIORITY||Risk Difference (RD)|14.0||||0.0391|TWO_SIDED|90.0|1.0|28.2|||Chan and Zhang Exact Method|||At Week 1: Risk difference = difference in percentage of participants.||28.2|1.0|0.0391
72440890|NCT03903822|144394663|SUPERIORITY||Risk Difference (RD)|0.0||||1|TWO_SIDED|90.0|-10.8|10.8|||Chan and Zhang Exact Method|||At Week 1: Risk difference = difference in percentage of participants.||10.8|-10.8|1.0000
72440891|NCT03903822|144394663|SUPERIORITY||Risk Difference (RD)|11.3||||0.0708|TWO_SIDED|90.0|-1.4|25.0|||Chan and Zhang Exact Method|||At Week 1: Risk difference = difference in percentage of participants.||25.0|-1.4|0.0708
72440892|NCT03903822|144394663|SUPERIORITY||Risk Difference (RD)|13.9||||0.0122|TWO_SIDED|90.0|4.7|27.0|||Chan and Zhang Exact Method|||At Week 1: Risk difference = difference in percentage of participants.||27.0|4.7|0.0122
72496053|NCT00654498|144521820|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.33|STANDARD_ERROR_OF_MEAN|0.18||0.0771|TWO_SIDED|95.0|-0.69|0.04|||ANCOVA|ANCOVA with treatment and center as fixed factors and baseline as a covariate||||0.04|-0.69|0.0771
72496054|NCT00654498|144521821|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.71|STANDARD_ERROR_OF_MEAN|0.25||0.0048|TWO_SIDED|95.0|-1.2|-0.22|||ANCOVA|ANCOVA with treatment and center as fixed factors and baseline as a covariate||||-0.22|-1.20|0.0048
72496055|NCT00654498|144521822|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|ANCOVA with treatment and center as fixed factors and baseline as a covariate||||||<0.0001
72440893|NCT03903822|144394663|SUPERIORITY||Risk Difference (RD)|21.6||||0.0016|TWO_SIDED|90.0|11.0|35.6|||Chan and Zhang Exact Method|||At Week 1: Risk difference = difference in percentage of participants.||35.6|11.0|0.0016
72440894|NCT03903822|144394663|SUPERIORITY||Risk Difference (RD)|2.7||||0.395|TWO_SIDED|90.0|-9.8|16.1|||Chan and Zhang Exact Method|||At Week 2: Risk difference = difference in percentage of participants.||16.1|-9.8|0.3950
72440895|NCT03903822|144394663|SUPERIORITY||Risk Difference (RD)|19.7||||0.0173|TWO_SIDED|90.0|4.2|35.6|||Chan and Zhang Exact Method|||At Week 2: Risk difference = difference in percentage of participants.||35.6|4.2|0.0173
72440896|NCT03903822|144394663|SUPERIORITY||Risk Difference (RD)|16.2||||0.0327|TWO_SIDED|90.0|1.4|31.0|||Chan and Zhang Exact Method|||At Week 2: Risk difference = difference in percentage of participants.||31.0|1.4|0.0327
72440897|NCT03903822|144394663|SUPERIORITY||Risk Difference (RD)|30.8||||0.0011|TWO_SIDED|90.0|13.2|46.6|||Chan and Zhang Exact Method|||At Week 2: Risk difference = difference in percentage of participants.||46.6|13.2|0.0011
72440898|NCT03903822|144394663|SUPERIORITY||Risk Difference (RD)|11.1||||0.1348|TWO_SIDED|90.0|-5.0|27.2|||Chan and Zhang Exact Method|||At Week 2: Risk difference = difference in percentage of participants.||27.2|-5.0|0.1348
72440899|NCT03903822|144394663|SUPERIORITY||Risk Difference (RD)|18.5||||0.0328|TWO_SIDED|90.0|1.5|34.8|||Chan and Zhang Exact Method|||At Week 2: Risk difference = difference in percentage of participants.||34.8|1.5|0.0328
72440900|NCT03903822|144394663|SUPERIORITY||Risk Difference (RD)|10.8||||0.0769|TWO_SIDED|90.0|-1.8|24.4|||Chan and Zhang Exact Method|||At Week 3: Risk difference = difference in percentage of participants.||24.4|-1.8|0.0769
72440901|NCT03903822|144394663|SUPERIORITY||Risk Difference (RD)|30.7||||0.0005|TWO_SIDED|90.0|13.2|46.0|||Chan and Zhang Exact Method|||At Week 3: Risk difference = difference in percentage of participants.||46.0|13.2|0.0005
72440902|NCT03903822|144394663|SUPERIORITY||Risk Difference (RD)|37.8|||<|0.0001|TWO_SIDED|90.0|22.1|53.1|||Chan and Zhang Exact Method|||At Week 3: Risk difference = difference in percentage of participants.||53.1|22.1|<0.0001
72440903|NCT03903822|144394663|SUPERIORITY||Risk Difference (RD)|36.3||||0.0001|TWO_SIDED|90.0|19.7|51.8|||Chan and Zhang Exact Method|||At Week 3: Risk difference = difference in percentage of participants.||51.8|19.7|0.0001
72440904|NCT03903822|144394663|SUPERIORITY||Risk Difference (RD)|0.0||||1|TWO_SIDED|90.0|-16.5|16.5|||Chan and Zhang Exact Method|||At Week 3: Risk difference = difference in percentage of participants.||16.5|-16.5|1.0000
72440905|NCT03903822|144394663|SUPERIORITY||Risk Difference (RD)|23.8||||0.0173|TWO_SIDED|90.0|4.5|41.5|||Chan and Zhang Exact Method|||At Week 3: Risk difference = difference in percentage of participants.||41.5|4.5|0.0173
72440906|NCT03903822|144394663|SUPERIORITY||Risk Difference (RD)|-2.7||||0.5663|TWO_SIDED|90.0|-19.9|14.2|||Chan and Zhang Exact Method|||At Week 4: Risk difference = difference in percentage of participants.||14.2|-19.9|0.5663
72440907|NCT03903822|144394663|SUPERIORITY||Risk Difference (RD)|14.6||||0.1243|TWO_SIDED|90.0|-3.8|32.6|||Chan and Zhang Exact Method|||At Week 4: Risk difference = difference in percentage of participants.||32.6|-3.8|0.1243
72496056|NCT00695565|144521823|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.5||||0.168|TWO_SIDED|95.0|||||Mixed Models Analysis|||This analysis does not take into account the subjects' screening capsaicin response (measure of nociceptor function).||||0.168
72496057|NCT00695565|144521823|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.2||||0.014|TWO_SIDED|95.0|||||Mixed Models Analysis|||"Each subject was screened for responsiveness of nociceptors in the skin to a capsaicin stimulus (rated on 0-10 pain scale; 0=no pain and 10=worst possible pain). The interaction term composed of treatment assignment and capsaicin threshold was examined at the prespecified alpha level of 0.1.~This analysis includes subjects with a capsaicin rating of ≥ 2. Thirty (30) subjects in the Placebo group and 33 subjects in the active Clonidine Topical Gel (ARC-4558) group had capsaicin scores ≥ 2."||||0.014
72496058|NCT01332071|144521837|NON_INFERIORITY_OR_EQUIVALENCE|This is a bioequivalence study. The study was performed to fulfill a specific regulatory demand of the Brazilian Regulatory Agency - ANVISA, in order to register a new dosage of medication.|Ratio T formulation/R formulation|96.58|||||TWO_SIDED|90.0|93.44|99.83|||||The ratio between the geometric means of the test (T) and reference (R) formulations was calculated.|||99.83|93.44|
72440908|NCT03903822|144394663|SUPERIORITY||Risk Difference (RD)|18.9||||0.046|TWO_SIDED|90.0|-0.5|36.6|||Chan and Zhang Exact Method|||At Week 4: Risk difference = difference in percentage of participants.||36.6|-0.5|0.0460
72440909|NCT03903822|144394663|SUPERIORITY||Risk Difference (RD)|25.7||||0.013|TWO_SIDED|90.0|4.8|43.3|||Chan and Zhang Exact Method|||At Week 4: Risk difference = difference in percentage of participants.||43.3|4.8|0.0130
72440910|NCT03903822|144394663|SUPERIORITY||Risk Difference (RD)|13.9||||0.1194|TWO_SIDED|90.0|-4.2|31.4|||Chan and Zhang Exact Method|||At Week 4: Risk difference = difference in percentage of participants.||31.4|-4.2|0.1194
72440911|NCT03903822|144394663|SUPERIORITY||Risk Difference (RD)|26.4||||0.0097|TWO_SIDED|90.0|6.5|44.4|||Chan and Zhang Exact Method|||At Week 4: Risk difference = difference in percentage of participants.||44.4|6.5|0.0097
72496059|NCT01332071|144521838|NON_INFERIORITY_OR_EQUIVALENCE|This is a bioequivalence study. The study was performed to fulfill a specific regulatory demand of the Brazilian Regulatory Agency - ANVISA, in order to register a new dosage of medication.|Ratio T formulation/R formulation|97.76|||||TWO_SIDED|90.0|93.25|102.5|||||The ratios between the geometric means of the test (T) and reference (R) formulations was calculated.|||102.50|93.25|
72496060|NCT01332071|144521839|NON_INFERIORITY_OR_EQUIVALENCE|This is a bioequivalence study. The study was performed to fulfill a specific regulatory demand of the Brazilian Regulatory Agency - ANVISA, in order to register a new dosage of medication.|Ratio T formulation/R formulation|96.47|||||TWO_SIDED|90.0|93.32|99.72|||||The ratio between the geometric means of the test (T) and reference (R) formulations was calculated.|||99.72|93.32|
72496061|NCT01332071|144521840|NON_INFERIORITY_OR_EQUIVALENCE|This is a bioequivalence study. The study was performed to fulfill a specific regulatory demand of the Brazilian Regulatory Agency - ANVISA, in order to register a new dosage of medication.|Ratio T formulation/R formulation|95.79|||||TWO_SIDED|90.0|91.67|100.1|||||The ratios between the geometric means of the test (T) and reference (R) formulations was calculated.|||100.10|91.67|
72496062|NCT01332071|144521841|NON_INFERIORITY_OR_EQUIVALENCE|This is a bioequivalence study. The study was performed to fulfill a specific regulatory demand of the Brazilian Regulatory Agency - ANVISA, in order to register a new dosage of medication.|Ratio T formulation/R formulation|94.86|||||TWO_SIDED|90.0|90.7|99.22|||||The ratios between the geometric means of the test (T) and reference (R) formulations was calculated.|||99.22|90.70|
72496063|NCT01332071|144521842|NON_INFERIORITY_OR_EQUIVALENCE|This is a bioequivalence study. The study was performed to fulfill a specific regulatory demand of the Brazilian Regulatory Agency - ANVISA, in order to register a new dosage of medication.|Ratio T formulation/R formulation|97.88|||||TWO_SIDED|90.0|93.15|102.86|||||The ratios between the geometric means of the test (T) and reference (R) formulations was calculated.|||102.86|93.15|
72496064|NCT01738971|144521843|SUPERIORITY_OR_OTHER||relative probability|3.13|||<|0.001||95.0|1.9|5.13|||t-test, 2 sided|see above description of analysis taking into account cluster randomisation||"Cluster randomised study design - statisitical analysis takes this into account. Analaysis was conducted at a cluster level and the proportions in each cluster using effective contraception were compared between groups by 2-sample t tests, weighted by the different number of patients in each cluster.~Comparison of number of women using effective contraception at 6-8 weeks in progestogen only pill group compared to control."||5.13|1.90|<0.001
72440912|NCT03903822|144394663|SUPERIORITY||Risk Difference (RD)|-2.7||||0.5556|TWO_SIDED|90.0|-21.0|16.1|||Chan and Zhang Exact Method|||At Week 6: Risk difference = difference in percentage of participants.||16.1|-21.0|0.5556
72440913|NCT03903822|144394663|SUPERIORITY||Risk Difference (RD)|17.6||||0.0761|TWO_SIDED|90.0|-2.5|36.5|||Chan and Zhang Exact Method|||At Week 6: Risk difference = difference in percentage of participants.||36.5|-2.5|0.0761
72440914|NCT03903822|144394663|SUPERIORITY||Risk Difference (RD)|18.9||||0.0583|TWO_SIDED|90.0|-0.8|37.6|||Chan and Zhang Exact Method|||At Week 6: Risk difference = difference in percentage of participants.||37.6|-0.8|0.0583
72440915|NCT03903822|144394663|SUPERIORITY||Risk Difference (RD)|14.9||||0.1245|TWO_SIDED|90.0|-5.0|33.7|||Chan and Zhang Exact Method|||At Week 6: Risk difference = difference in percentage of participants.||33.7|-5.0|0.1245
72440916|NCT03903822|144394663|SUPERIORITY||Risk Difference (RD)|19.4||||0.0382|TWO_SIDED|90.0|1.5|36.5|||Chan and Zhang Exact Method|||At Week 6: Risk difference = difference in percentage of participants.||36.5|1.5|0.0382
72440917|NCT03903822|144394663|SUPERIORITY||Risk Difference (RD)|34.7||||0.0011|TWO_SIDED|90.0|13.2|51.4|||Chan and Zhang Exact Method|||At Week 6: Risk difference = difference in percentage of participants.||51.4|13.2|0.0011
72440918|NCT00895531|144394689|SUPERIORITY|||||||0.95|||||||t-test, 2 sided|||||||0.95
72440919|NCT01195883|144394690|SUPERIORITY||Risk Ratio (RR)|0.9||||0.51|TWO_SIDED|95.0|0.65|1.23|||GEE model|||||1.23|0.65|0.51
72440920|NCT01195883|144394691|SUPERIORITY||Risk Ratio (RR)|0.95||||0.42|TWO_SIDED|95.0|0.81|1.11|||Chi-squared|||||1.11|0.81|0.42
72440921|NCT01195883|144394692|SUPERIORITY||Risk Ratio (RR)|0.89||||0.26|TWO_SIDED|95.0|0.72|1.09|||Chi-squared|||||1.09|0.72|0.26
72387526|NCT02609828|144283482|SUPERIORITY||Difference in LS mean|-1.2|STANDARD_ERROR_OF_MEAN|0.72||0.1034|TWO_SIDED|95.0|-2.65|0.26|||ANCOVA|||Change at Week 12: ANCOVA model for imputed datasets included treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the non-index cancer pain sites and baseline opioid dose as covariates.||0.26|-2.65|0.1034
72440922|NCT01195883|144394693|SUPERIORITY||Odds Ratio (OR)|1.33||||0.4|TWO_SIDED|95.0|0.69|2.58|||Chi-squared|||||2.58|0.69|0.40
72619011|NCT01122680|144768418|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.046|STANDARD_ERROR_OF_MEAN|0.039||||95.0|-0.031|0.124|||Mixed effect repeated measures (MMRM)|This MMRM model includes treatment, period and baseline as fixed effects, and patient as a random effect.||Tio R5 minus Tio R1.25||0.124|-0.031|
72440923|NCT01061671|144394718|SUPERIORITY_OR_OTHER|||||||0.54|TWO_SIDED||||||negative binomial regression|Adjustments of confidence intervals for between-participant variation (overdispersion).||||||0.54
72440924|NCT01061671|144394719|SUPERIORITY_OR_OTHER|||||||0.34|TWO_SIDED||||||Log Rank|||||||0.34
72440925|NCT01061671|144394720|SUPERIORITY_OR_OTHER|||||||0.1461|TWO_SIDED||||||t-test, 2 sided|||||||.1461
72440926|NCT00475501|144394733|SUPERIORITY_OR_OTHER||Mean Difference (Net)|12.9|STANDARD_DEVIATION|2.57|<|0.001|TWO_SIDED|95.0|7.86|18.0||The difference in means and p value are for 12 months (using data from all time points to make the calculation). We tested the effect of testosterone (\[T-placebo plus T-finasteride\] vs. \[vehicle-placebo plus vehicle-finasteride\]).|Mixed Models Analysis||mean difference is for subjects reveiving testosterone (groups T and T/F) vs. subjects not receiving testosterone (F and Placebo)|The studies was powered for 1-RM strength based on a 1.18-alpha increase reported in the literature||18.0|7.86|<0.001
72440927|NCT00475501|144394734|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.77|STANDARD_DEVIATION|0.311||0.015|TWO_SIDED|95.0|0.16|1.31||The difference in means and p value are for 12 months (using data from all time points to make the calculation). We tested the effect of testosterone (\[T-placebo plus T-finasteride\] vs. \[vehicle-placebo plus vehicle-finasteride\]).|Mixed Models Analysis|||The study was not powered on grip strength. We employed 2x2 analysis to determine effects of testosterone, finasteride and interaction.||1.31|0.16|0.015
72619012|NCT01122680|144768418|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.056|STANDARD_ERROR_OF_MEAN|0.036||||95.0|-0.014|0.126|||Mixed effect repeated measures (MMRM)|This MMRM model includes treatment, period and baseline as fixed effects, and patient as a random effect.||Tio R5 minus Tio R2.5||0.126|-0.014|
72619013|NCT01122680|144768418|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.04||||95.0|-0.088|0.069|||Mixed effect repeated measures (MMRM)|This MMRM model includes treatment, period and baseline as fixed effects, and patient as a random effect.||Tio R2.5 minus Tio R1.25||0.069|-0.088|
72619014|NCT00564070|144768448|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|30.2|||<|0.0001|TWO_SIDED|95.0|17.37|42.9|||Mixed Models Analysis|General linear model, controlling for baseline values|The Mean Difference was calculated as percent adherence to glucose monitoring for the CBT-AD Arm minus the adherence to glucose monitoring for the Enhanced Treatment as Usual Arm.|Multiple imputation was used to handle missing data; analyses are reported for the acute outcomes of glucose monitoring (i.e., 4 month)||42.9|17.37|<.0001
72619015|NCT00564070|144768449|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.72|||=|0.001|TWO_SIDED|95.0|0.29|1.15|||ANCOVA|General linear model; Controlling for baseline values|The Mean Difference was calculated as percent of HbA1c for the Enhanced Treatment as Usual Arm minus percent of HbA1c for the CBT-AD Arm.|Multiple imputation was used to handle missing data; results are reported for HbA1c at the acute outcome (i.e., 4 months)||1.15|.29|=.001
72440928|NCT00475501|144394735|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.19|STANDARD_DEVIATION|1.142|<|0.001|TWO_SIDED|95.0|1.95|6.43||The difference in means and p value are for 12 months (using data from all time points to make the calculation). We tested the effect of testosterone (\[T-placebo plus T-finasteride\] vs. \[vehicle-placebo plus vehicle-finasteride\]).|Mixed Models Analysis|||The study was not powered on lumbar spine bone mineral density. We employed a 2x2 analysis for effects ot testosterone, finasteride and interaction||6.43|1.95|<0.001
72440929|NCT00475501|144394736|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.737|STANDARD_ERROR_OF_MEAN|0.343||0.037|TWO_SIDED|95.0|-1.41|-0.064||The difference in means and p value are for 12 months (using data from all time points to make the calculation). We tested the effect of testosterone (\[T-placebo plus T-finasteride\] vs. \[vehicle-placebo plus vehicle-finasteride\]).|Mixed Models Analysis|||The study is was not powered for score on Geriatric Depression Scale||-0.064|-1.41|0.037
72440930|NCT00475501|144394737|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.871|STANDARD_ERROR_OF_MEAN|1.108||0.012|TWO_SIDED|95.0|0.699|5.04||The difference in means and p value are for 12 months (using data from all time points to make the calculation). We tested the effect of testosterone (\[T-placebo plus T-finasteride\] vs. \[vehicle-placebo plus vehicle-finasteride\]).|Mixed Models Analysis|||The study was not powered for 30-minute recall on Rey figure test||5.04|0.699|0.012
72440931|NCT00475501|144394738|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.642|STANDARD_ERROR_OF_MEAN|2.272||0.779|TWO_SIDED|95.0|-5.095|3.811||The difference in means and p value are for 12 months (using data from all time points to make the calculation). We tested the effect of testosterone (\[T-placebo plus T-finasteride\] vs. \[vehicle-placebo plus vehicle-finasteride\]).|Mixed Models Analysis|||The study was not powered for score on Trials A test||3.811|-5.095|0.779
72440932|NCT00475501|144394739|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.587|STANDARD_ERROR_OF_MEAN|0.743||0.433|TWO_SIDED|95.0|-0.869|2.043||The difference in means and p value are for 12 months (using data from all time points to make the calculation). We tested the effect of testosterone (\[T-placebo plus T-finasteride\] vs. \[vehicle-placebo plus vehicle-finasteride\]).|Mixed Models Analysis|||The study was not powered for score on Benton test||2.043|-0.869|0.433
72440933|NCT00475501|144394740|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.13|STANDARD_DEVIATION|0.54|<|0.001|TWO_SIDED|95.0|3.07|5.18||The difference in means and p value are for 12 months (using data from all time points to make the calculation). We tested the effect of testosterone (\[T-placebo plus T-finasteride\] vs. \[vehicle-placebo plus vehicle-finasteride\]).|Mixed Models Analysis|||This study was powered for hematocrit based on literature report that testosterone \> 2 alpha increase in hematocrit||5.18|3.07|<0.001
72440934|NCT00475501|144394741|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.1419|STANDARD_ERROR_OF_MEAN|0.2529||0.6219|TWO_SIDED|95.0|-0.353|6.37||The difference in means and p value are for 12 months (using data from all time points to make the calculation). We tested the effect of testosterone (\[T-placebo plus T-finasteride\] vs. \[vehicle-placebo plus vehicle-finasteride\]).|Mixed Models Analysis|||The study was not powered for dietary protein intake||6.37|-0.353|0.6219
72440935|NCT00475501|144394742|SUPERIORITY_OR_OTHER||Mean Difference (Net)|5.33|STANDARD_DEVIATION|1.83||0.0051|TWO_SIDED|95.0|1.73|8.94||The difference in means and p value are for 12 months (using data from all time points to make the calculation). We tested the effect of testosterone (\[T-placebo plus T-finasteride\] vs. \[vehicle-placebo plus vehicle-finasteride\]).|Mixed Models Analysis|||The study was powered for prostate volume based on a literature report that testosterone increases prostate volume 1.85 alpha per year. We employed a 2x2 analysis for effects of testosterone, finasteride and interaction.||8.94|1.73|0.0051
72440936|NCT00475501|144394743|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.868|STANDARD_ERROR_OF_MEAN|0.668||0.196|TWO_SIDED|95.0|-3.434|1.698||The difference in means and p value are for 12 months (using data from all time points to make the calculation). We tested the effect of testosterone (\[T-placebo plus T-finasteride\] vs. \[vehicle-placebo plus vehicle-finasteride\]).|Mixed Models Analysis|||The study was not powered for score on Lif Satisfaction A test||1.698|-3.434|0.196
72440937|NCT01803555|144394770|NON_INFERIORITY|The noninferiority of BF Spiromax to Symbicort Turbohaler was demonstrated if the lower limit of the 2-sided 95% confidence interval (CI) for the treatment difference was greater than -15 L/min.|Least Square (LS) mean difference|-2.957||||0.3387|TWO_SIDED|95.0|-9.02|3.11|||Mixed Models Analysis|Analysis included effects due to baseline weekly average of daily trough AM PEF, gender, age, treatment, time, and treatment-by-time interaction.||||3.11|-9.02|0.3387
72440938|NCT01551355|144394775|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.9|||<|0.001|TWO_SIDED|95.0|1.64|6.16|||t-test, 2 sided|The intervention was evaluated using generalized estimating equation models, controlling for cluster effect, sex, age, weight, and education level.||||6.16|1.64|<.001
72440939|NCT01551355|144394776|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.08|||<|0.001|TWO_SIDED|95.0|2.03|6.12|||t-test, 2 sided|||||6.12|2.03|<.001
72440940|NCT01551355|144394777|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.36|||=|0.06|TWO_SIDED|95.0|-0.29|11.01|||t-test, 2 sided|||||11.01|-0.29|=.06
72440941|NCT02409667|144394779|NON_INFERIORITY|The statistical null-hypothesis to be rejected in the primary analysis was that the odds ratio of maintaining a PASI 90 response for patients with secukinumab 4-weekly dosing versus patients on secukinumab 6-weekly dosing exceeds the non-inferiority margin of 1+δ.|Odds Ratio (OR)|1.91||||0.1499|TWO_SIDED|95.0|1.44|2.55|||Regression, Logistic|||||2.55|1.44|0.1499
72440942|NCT02409667|144394780|SUPERIORITY||Odds Ratio (OR)|0.62||||0.1013|TWO_SIDED|95.0|0.35|1.1|||Regression, Logistic|||||1.10|0.35|0.1013
72440943|NCT02409667|144394783|SUPERIORITY||Least square mean (LSM) estimate|-0.09||||0.0489|TWO_SIDED|95.0|-0.18|0.0|||ANCOVA|||Week 28||-0.00|-0.18|0.0489
72440944|NCT02409667|144394783|SUPERIORITY||LSM estimate|-0.09||||0.1073|TWO_SIDED|95.0|-0.19|0.02|||ANCOVA|||Week 32||0.02|-0.19|0.1073
72496065|NCT01738971|144521843|SUPERIORITY_OR_OTHER||relative probability|2.57||||0.006||95.0|1.55|4.27||see above comments regarding analysis taking cluster randomised account into consideration|t-test, 2 sided|||"Cluster randomised study design - statisitical analysis takes this into account. Analaysis was conducted at a cluster level and the proportions in each cluster using effective contraception were compared between groups by 2-sample t tests, weighted by the different number of patients in each cluster.~Comparison of number of women using effective contraception at 6-8 weeks in rapid access group compared to control."||4.27|1.55|0.006
72440945|NCT02409667|144394783|SUPERIORITY||LSM estimate|-0.24||||0.0001|TWO_SIDED|95.0|-0.37|-0.12|||ANCOVA|||Week 36||-0.12|-0.37|0.0001
72440946|NCT02409667|144394783|SUPERIORITY||LSM estimate|-0.25||||0.0005|TWO_SIDED|95.0|-0.38|-0.11|||ANCOVA|||Week 40||-0.11|-0.38|0.0005
72440947|NCT02409667|144394783|SUPERIORITY||LSM estimate|-0.3||||0.0001|TWO_SIDED|95.0|-0.45|-0.15|||ANCOVA|||Week 44||-0.15|-0.45|0.0001
72440948|NCT02409667|144394783|SUPERIORITY||LSM estimate|-0.49||||0|TWO_SIDED|95.0|-0.7|-0.27|||ANCOVA|||Week 48||-0.27|-0.70|0.0000
72440949|NCT02409667|144394783|SUPERIORITY||LSM mean|-0.59||||0|TWO_SIDED|95.0|-0.81|-0.36|||ANCOVA|||||-0.36|-0.81|0.0000
72440950|NCT02409667|144394784|SUPERIORITY||LSM estimate|0.4||||0.174|TWO_SIDED|95.0|-0.18|0.99|||ANCOVA|||Week 28||0.99|-0.18|0.1740
72440951|NCT02409667|144394784|SUPERIORITY||LSM estimate|0.79||||0.0287|TWO_SIDED|95.0|0.08|1.5|||ANCOVA|||Week 32||1.50|0.08|0.0287
72440952|NCT02409667|144394784|SUPERIORITY||LSM estimate|0.62||||0.1202|TWO_SIDED|95.0|-0.16|1.41|||ANCOVA|||Week 36||1.41|-0.16|0.1202
72440953|NCT02409667|144394784|SUPERIORITY||LSM estimate|0.75||||0.1157|TWO_SIDED|95.0|-0.19|1.68|||ANCOVA|||Week 40||1.68|-0.19|0.1157
72440954|NCT02409667|144394784|SUPERIORITY||LSM estimate|0.54||||0.3189|TWO_SIDED|95.0|-0.52|1.59|||ANCOVA|||Week 44||1.59|-0.52|0.3189
72440955|NCT02409667|144394784|SUPERIORITY||LSM estimate|1.17||||0.024|TWO_SIDED|95.0|0.16|2.18|||ANCOVA|||Week 48||2.18|0.16|0.0240
72440956|NCT02409667|144394784|SUPERIORITY||LSM estimate|1.47||||0.009|TWO_SIDED|95.0|0.37|2.57|||ANCOVA|||Week 52||2.57|0.37|0.0090
72440957|NCT02409667|144394785|SUPERIORITY||LSM estimate|-0.62||||0.0001|TWO_SIDED|95.0|-0.93|-0.31|||ANCOVA|||||-0.31|-0.93|0.0001
72440958|NCT02409667|144394786|SUPERIORITY||LSM estimate|1.17||||0.0675|TWO_SIDED|95.0|-0.09|2.42|||ANCOVA|||||2.42|-0.09|0.0675
72440959|NCT02409667|144394787|SUPERIORITY||LSM estimate|-0.97||||0.2101|TWO_SIDED|95.0|-2.48|0.55|||ANCOVA|||Absenteeism||0.55|-2.48|0.2101
72440960|NCT02409667|144394787|SUPERIORITY||LSM estimate|-0.67||||0.2971|TWO_SIDED|95.0|-1.93|0.59|||ANCOVA|||Presenteeism||0.59|-1.93|0.2971
72440961|NCT02409667|144394787|SUPERIORITY||LSM estimate|-0.61||||0.5499|TWO_SIDED|95.0|-2.59|1.38|||ANCOVA|||Total activity impairment||1.38|-2.59|0.5499
72440962|NCT02409667|144394787|SUPERIORITY||LSM estimate|-1.08||||0.0758|TWO_SIDED|95.0|-2.28|0.11|||ANCOVA|||||0.11|-2.28|0.0758
72440963|NCT02409667|144394788|SUPERIORITY||LSM estimate|1.2||||0.4156|TWO_SIDED|95.0|-1.71|4.11|||ANCOVA|||Absenteeism||4.11|-1.71|0.4156
72440964|NCT02409667|144394788|SUPERIORITY||LSM estimate|0.63||||0.8619|TWO_SIDED|95.0|-6.59|7.85|||ANCOVA|||Presenteeism||7.85|-6.59|0.8619
72440965|NCT02409667|144394788|SUPERIORITY||LSM estimate|-0.61||||0.6139|TWO_SIDED|95.0|-6.31|10.61|||ANCOVA|||Total activity impairment||10.61|-6.31|0.6139
72440966|NCT02409667|144394788|SUPERIORITY||LSM estimate|1.7||||0.5674|TWO_SIDED|95.0|-4.16|7.56|||ANCOVA|||Work productivity loss||7.56|-4.16|0.5674
72440967|NCT02409667|144394789|SUPERIORITY||LSM estimate|-0.13||||0.1219|TWO_SIDED|95.0|-0.3|0.04|||ANCOVA|||Pain||0.04|-0.30|0.1219
72440968|NCT02409667|144394789|SUPERIORITY||LSM estimate|-0.38||||0.0001|TWO_SIDED|95.0|-0.57|-0.18|||ANCOVA|||Itching||-0.18|-0.57|0.0001
72440969|NCT02409667|144394789|SUPERIORITY||LSM estimate|-0.31||||0.0003|TWO_SIDED|95.0|-0.48|-0.14|||ANCOVA|||Scaling||-0.14|-0.48|0.0003
72440970|NCT02409667|144394790|SUPERIORITY||LSM estimate|0.17||||0.6457|TWO_SIDED|95.0|-0.57|0.92|||ANCOVA|||Pain||0.92|-0.57|0.6457
72440971|NCT02409667|144394790|SUPERIORITY||LSM estimate|0.19||||0.6136|TWO_SIDED|95.0|-0.56|0.94|||ANCOVA|||Itching||0.94|-0.56|0.6136
72440972|NCT02409667|144394790|SUPERIORITY||LSM estimate|0.75||||0.0203|TWO_SIDED|95.0|0.12|1.39|||ANCOVA|||Scaling||1.39|0.12|0.0203
72496066|NCT00692211|144521867|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.56||||0.01|TWO_SIDED|95.0|1.04|2.32||Not adjusted for multiple comparisons, a priori threshold of 0.05|Regression, Logistic|||Study powered to detect 10% difference in proportion of screening adherence based on alpha of 0.05, beta 0.20.||2.32|1.04|0.01
72496067|NCT02531646|144521871|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence interval (-0.25, 0.25)||||||0||||||"Level of significance (alpha) = 0.05~All p-values were calculated (and verified) by our statistician.They were rounded to fit four digits."|Equivalence test|||||||0.000
72440973|NCT02409667|144394791|SUPERIORITY||LSM estimate|2.22||||0.0027|TWO_SIDED|95.0|0.77|3.68|||ANCOVA|||||3.68|0.77|0.0027
72440974|NCT02409667|144394792|SUPERIORITY||LSM estimate|-2.31||||0.2823|TWO_SIDED|95.0|-6.55|1.92|||ANCOVA|||||1.92|-6.55|0.2823
72440975|NCT02409667|144394793|SUPERIORITY||LSM estimate|0.01||||0.0861|TWO_SIDED|95.0|0.0|0.02|||ANCOVA|||Germany||0.02|-0.00|0.0861
72440976|NCT02409667|144394793|SUPERIORITY||LSM estimate|0.02||||0.0117|TWO_SIDED|95.0|0.0|0.04|||ANCOVA|||UK||0.04|0.00|0.0117
72440977|NCT02409667|144394794|SUPERIORITY||LSM estimate|-0.02||||0.1852|TWO_SIDED|95.0|-0.05|0.01|||ANCOVA|||Germany||0.01|-0.05|0.1852
72440978|NCT02409667|144394794|SUPERIORITY||LSM estimate|-0.03||||0.2203|TWO_SIDED|95.0|-0.07|0.02|||ANCOVA|||UK||0.02|-0.07|0.2203
72440979|NCT01827787|144394799|SUPERIORITY|||||||0.42|||||||Fisher Exact|||"Using a one sample binomial design, with 45 patients there was 90% power to detect a null hypothesis 30% overall response rate (historical control) versus an alternative hypothesis of 53% overall response rate assuming a two-sided 10% alpha.~Of note, cohort 2: TNBC did not fully accrue 45 patients so a testing was not done."||||0.42
72440980|NCT03482635|144394808|OTHER||Risk Difference (RD)|0.042|||||TWO_SIDED|95.0|-0.105|0.202|||||Unadjusted absolute risk difference to placebo, \[Treatment - Placebo\]. 95% CI for risk difference were calculated using the method of Newcombe.|||0.202|-0.105|
72440981|NCT03482635|144394808|OTHER||Risk Difference (RD)|0.087|||||TWO_SIDED|95.0|-0.069|0.268|||||Unadjusted absolute risk difference to placebo, \[Treatment - Placebo\]. 95% CI for risk difference were calculated using the method of Newcombe.|||0.268|-0.069|
72440982|NCT03482635|144394808|OTHER||Risk Difference (RD)|0.071|||||TWO_SIDED|95.0|-0.081|0.226|||||Unadjusted absolute risk difference to placebo, \[Treatment - Placebo\]. 95% CI for risk difference were calculated using the method of Newcombe.|||0.226|-0.081|
72440983|NCT03482635|144394809|OTHER||Risk Difference (RD)|-0.051|||||TWO_SIDED|95.0|-0.276|0.176|||||Unadjusted absolute risk difference to placebo, \[Treatment - Placebo\]. 95% CI for risk difference were calculated using the method of Newcombe.|||0.176|-0.276|
72440984|NCT03482635|144394809|OTHER||Risk Difference (RD)|0.043|||||TWO_SIDED|95.0|-0.199|0.28|||||Unadjusted absolute risk difference to placebo, \[Treatment - Placebo\]. 95% CI for risk difference were calculated using the method of Newcombe.|||0.280|-0.199|
72440985|NCT03482635|144394809|OTHER||Risk Difference (RD)|0.033|||||TWO_SIDED|95.0|-0.204|0.252|||||Unadjusted absolute risk difference to placebo, \[Treatment - Placebo\]. 95% CI for risk difference were calculated using the method of Newcombe.|||0.252|-0.204|
72440986|NCT03482635|144394810|OTHER||Risk Difference (RD)|0.083|||||TWO_SIDED|95.0|-0.072|0.258|||||Unadjusted absolute risk difference to placebo, \[Treatment - Placebo\]. 95% CI for risk difference were calculated using the method of Newcombe.|||0.258|-0.072|
72440987|NCT03482635|144394810|OTHER||Risk Difference (RD)|0.087|||||TWO_SIDED|95.0|-0.069|0.268|||||Unadjusted absolute risk difference to placebo, \[Treatment - Placebo\]. 95% CI for risk difference were calculated using the method of Newcombe.|||0.268|-0.069|
72440988|NCT03482635|144394810|OTHER||Risk Difference (RD)|0.071|||||TWO_SIDED|95.0|-0.081|0.226|||||Unadjusted absolute risk difference to placebo, \[Treatment - Placebo\]. 95% CI for risk difference were calculated using the method of Newcombe.|||0.226|-0.081|
72440989|NCT03482635|144394811|OTHER||Risk Difference (RD)|0.083|||||TWO_SIDED|95.0|-0.072|0.258|||||Unadjusted absolute risk difference to placebo, \[Treatment - Placebo\].|||0.258|-0.072|
72440990|NCT03482635|144394811|OTHER||Risk Difference (RD)|0.043|||||TWO_SIDED|95.0|-0.104|0.21|||||Unadjusted absolute risk difference to placebo, \[Treatment - Placebo\].|||0.210|-0.104|
72440991|NCT03482635|144394811|OTHER||Risk Difference (RD)|0.036|||||TWO_SIDED|95.0|-0.11|0.177|||||Unadjusted absolute risk difference to placebo, \[Treatment - Placebo\].|||0.177|-0.110|
72496068|NCT02531646|144521872|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence interval (-0.25, 0.25)||||||0||||||"Level of significance (alpha) = 0.05~All p-values were calculated (and verified) by our statistician.They were rounded to fit four digits."|Equivalence test|||||||0.000
72496069|NCT02531646|144521873|SUPERIORITY_OR_OTHER|||||||0||||||"Level of significance (alpha) = 0.05~All p-values were calculated (and verified) by our statistician.They were rounded to fit four digits."|t-test, 1 sided|||||||0.000
72496070|NCT02531646|144521874|SUPERIORITY_OR_OTHER|||||||0||||||"Level of significance (alpha) = 0.05~All p-values were calculated (and verified) by our statistician. They were rounded to fit four digits."|t-test, 1 sided|||||||0.000
72496071|NCT02531646|144521875|SUPERIORITY_OR_OTHER|||||||0.007||||||"Level of significance (alpha) = 0.05~All p-values were calculated (and verified) by our statistician. They were rounded to fit four digits."|t-test, 1 sided|||||||0.007
72440992|NCT03482635|144394812|OTHER||Difference of adjusted means|-0.3|STANDARD_ERROR_OF_MEAN|10.7||0.9776|TWO_SIDED|95.0|-21.6|21.0|||Mixed Models Analysis|||Restricted maximum likelihood (REML)-based repeated measures approach. The model included fixed, categorical effects of treatment, visit, and treatment by visit interaction, and stratification factors (prior biologic treatment failure and concomitant corticosteroid therapy at Visit 2/randomisation), as well as the continuous fixed covariates of baseline and baseline-by-visit interaction. An unstructured covariance structure was used to model the within-patient measurements.||21.0|-21.6|0.9776
72440993|NCT03482635|144394812|OTHER||Difference of adjusted means|1.4|STANDARD_ERROR_OF_MEAN|10.6||0.894|TWO_SIDED|95.0|-19.6|22.4|||Mixed Models Analysis|||Restricted maximum likelihood (REML)-based repeated measures approach. The model included fixed, categorical effects of treatment, visit, and treatment by visit interaction, and stratification factors (prior biologic treatment failure and concomitant corticosteroid therapy at Visit 2/randomisation), as well as the continuous fixed covariates of baseline and baseline-by-visit interaction. An unstructured covariance structure was used to model the within-patient measurements.||22.4|-19.6|0.8940
72440994|NCT03482635|144394812|OTHER||Difference of adjusted means|1.0|STANDARD_ERROR_OF_MEAN|10.6||0.9241|TWO_SIDED|95.0|-20.0|22.1|||Mixed Models Analysis|||Restricted maximum likelihood (REML)-based repeated measures approach. The model included fixed, categorical effects of treatment, visit, and treatment by visit interaction, and stratification factors (prior biologic treatment failure and concomitant corticosteroid therapy at Visit 2/randomisation), as well as the continuous fixed covariates of baseline and baseline-by-visit interaction. An unstructured covariance structure was used to model the within-patient measurements||22.1|-20.0|0.9241
72440995|NCT05165485|144394822|SUPERIORITY||Mean Difference (Net)|-23.0||||0.22|TWO_SIDED|95.0|-61.0|14.0||The familywise type 1 error rate is controlled at 0.05 by testing the primary and secondary endpoint hypotheses in sequence, stopping after the first failure to reject the null hypothesis.|Mixed Models Analysis|Denominator degrees of freedom were approximated by the Kenward and Roger (1997) method.|Revefenacin - Tiotropium Least Squares Mean Difference|The null hypothesis was that the Revefenacin - Tiotropium Least Squares Mean Difference was zero and the alternative hypothesis was that it was nonzero.|The Revefenacin - Tiotropium Least Squares Mean Difference was estimated by fitting a repeated measures mixed model which included terms for participant, treatment, 6 categorical covariates, and 3 continuous covariates: baseline FEV1, screening FEV1, and baseline PIFR. The 6 categorical covariates were reversibility to ipratropium status (reversible/not reversible), smoking status (current/former), concomitant LABA or LABA/ICS use (Yes/No), GOLD airflow category (3/4, i.e., postipratropium FEV1 % predicted \< 30%/≥ 30%), sex (woman/man), and age group (\< 65/≥ 65).|14|-61|0.22
72440996|NCT05165485|144394823|SUPERIORITY||Mean Difference (Net)|-9.0|||||TWO_SIDED|95.0|-38.0|20.0||The familywise type 1 error rate is controlled at 0.05 by testing the primary and secondary endpoint hypotheses in sequence and stopping after the first failure to reject the null hypothesis. Accordingly, the p-value is not shown.|Mixed Models Analysis||Revefenacin - Tiotropium Least Squares Mean Difference|The OTE is defined as the average of the Day 30, Day 60, and Day 85 Revefenacin - Tiotropium Least Squares Mean differences. The null hypothesis was that the OTE Revefenacin - Tiotropium Least Squares Mean Difference was zero and the alternative hypothesis was that it was nonzero.|The Revefenacin - Tiotropium Least Squares Mean Difference was estimated by fitting a repeated measures mixed model which included terms for participant, treatment, 6 categorical covariates, and 3 continuous covariates: baseline FEV1, screening FEV1, and baseline PIFR. The 6 categorical covariates were reversibility to ipratropium status (reversible/not reversible), smoking status (current/former), concomitant LABA or LABA/ICS use (Yes/No), GOLD airflow category (3/4, i.e., postipratropium FEV1 % predicted \< 30%/≥ 30%), sex (woman/man), and age group (\< 65/≥ 65).|20|-38|
72440997|NCT05165485|144394824|SUPERIORITY||Mean Difference (Net)|2.0|||||TWO_SIDED|95.0|-29.0|32.0||The familywise type 1 error rate is controlled at 0.05 by testing the primary and secondary endpoint hypotheses in sequence and stopping after the first failure to reject the null hypothesis. Accordingly, the p-value is not shown.|Mixed Models Analysis||Revefenacin - Tiotropium Least Squares Mean Difference|The null hypothesis was that the Revefenacin - Tiotropium Least Squares Mean Difference was zero and the alternative hypothesis was that it was nonzero.|The Revefenacin - Tiotropium Least Squares Mean Difference was estimated by fitting a repeated measures mixed model which included terms for participant, treatment, 6 categorical covariates, and 3 continuous covariates: baseline FEV1, screening FEV1, and baseline PIFR. The 6 categorical covariates were reversibility to ipratropium status (reversible/not reversible), smoking status (current/former), concomitant LABA or LABA/ICS use (Yes/No), GOLD airflow category (3/4, i.e., postipratropium FEV1 % predicted \< 30%/≥ 30%), sex (woman/man), and age group (\< 65/≥ 65).|32|-29|
72496072|NCT02531646|144521877|SUPERIORITY_OR_OTHER|||||||0||||||"Level of significance (alpha) = 0.05~All p-values were calculated (and verified) by our statistician. They were rounded to fit four digits."|t-test, 1 sided|||||||0.000
72496073|NCT05888103|144521904|SUPERIORITY||LS Mean Difference|-47.5|||<|0.0001|TWO_SIDED|95.0|-52.35|-42.65|||ANCOVA|||||-42.65|-52.35|<0.0001
72496074|NCT05888103|144521905|SUPERIORITY||LS Mean Difference|-69.73|||<|0.0001|TWO_SIDED|95.0|-76.6|-62.86|||ANCOVA|||||-62.86|-76.60|<0.0001
72496075|NCT05888103|144521906|SUPERIORITY||LS Mean Difference|-77.83|||<|0.0001|TWO_SIDED|95.0|-85.86|-69.8|||ANCOVA|||||-69.80|-85.86|<0.0001
72496076|NCT05888103|144521907|SUPERIORITY||LS Mean Difference|-226.61|||<|0.0001|TWO_SIDED|95.0|-244.77|-208.45|||ANCOVA|||||-208.45|-244.77|<0.0001
72496077|NCT05888103|144521908|SUPERIORITY||LS Mean Difference|-31.49|||<|0.0001|TWO_SIDED|95.0|-34.91|-28.07|||ANCOVA|||||-28.07|-34.91|<0.0001
72496078|NCT05888103|144521909|SUPERIORITY||LS Mean Difference|-71.46|||<|0.0001|TWO_SIDED|95.0|-79.24|-63.69|||ANCOVA|||||-63.69|-79.24|<0.0001
72496079|NCT05888103|144521910|SUPERIORITY||LS Mean Difference|2.94||||0.3743|TWO_SIDED|95.0|-3.55|9.42|||ANCOVA|||||9.42|-3.55|0.3743
72496080|NCT05888103|144521911|SUPERIORITY||LS Mean Difference|1.07||||0.4228|TWO_SIDED|95.0|-1.54|3.68|||ANCOVA|||||3.68|-1.54|0.4228
72496081|NCT05888103|144521912|SUPERIORITY||LS Mean Difference|-40.57|||<|0.0001|TWO_SIDED|95.0|-44.57|-36.57|||ANCOVA|||||-36.57|-44.57|<0.0001
72496082|NCT05888103|144521913|SUPERIORITY||LS Mean Difference|-72.34|||<|0.0001|TWO_SIDED|95.0|-79.56|-65.13|||ANCOVA|||||-65.13|-79.56|<0.0001
72496083|NCT05888103|144521914|SUPERIORITY||LS Mean Difference|-36.84|||<|0.0001|TWO_SIDED|95.0|-40.72|-32.96|||ANCOVA|||||-32.96|-40.72|<0.0001
72496084|NCT05888103|144521915|SUPERIORITY||LS Mean Difference|-41.87|||<|0.0001|TWO_SIDED|95.0|-46.28|-37.47|||ANCOVA|||||-37.47|-46.28|<0.0001
72496085|NCT05888103|144521916|SUPERIORITY||LS Mean Difference|2.05||||0.3011|TWO_SIDED|95.0|-1.84|5.93|||ANCOVA|||||5.93|-1.84|0.3011
72496086|NCT05888103|144521917|SUPERIORITY||LS Mean Difference|3.13||||0.2403|TWO_SIDED|95.0|-2.09|8.35|||ANCOVA|||||8.35|-2.09|0.2403
72559205|NCT01634139|144648086|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.043|STANDARD_ERROR_OF_MEAN|0.05||0.3897|TWO_SIDED|95.0|-0.141|0.055|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 48||0.055|-0.141|0.3897
72387527|NCT02609828|144283482|SUPERIORITY||Difference in LS mean|-1.91|STANDARD_ERROR_OF_MEAN|0.84||0.029|TWO_SIDED|95.0|-3.6|-0.21|||ANCOVA|||Change at Week 16: ANCOVA model for imputed datasets included treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the non-index cancer pain sites and baseline opioid dose as covariates.||-0.21|-3.60|0.0290
72496087|NCT05888103|144521918|SUPERIORITY||LS Mean Difference|-30.27|||<|0.0001|TWO_SIDED|95.0|-40.58|-19.95|||ANCOVA|||||-19.95|-40.58|<0.0001
72387528|NCT02609828|144283482|SUPERIORITY||Difference in LS mean|-1.62|STANDARD_ERROR_OF_MEAN|0.83||0.06|TWO_SIDED|95.0|-3.31|0.07|||ANCOVA|||Change at Week 24: ANCOVA model for imputed datasets included treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the non-index cancer pain sites and baseline opioid dose as covariates.||0.07|-3.31|0.0600
72387529|NCT02609828|144283485|SUPERIORITY||Odds Ratio (OR)|1.14||||0.8054|TWO_SIDED|95.0|0.41|3.18|||Regression, Logistic|||Week 1 Reduction \>=30%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||3.18|0.41|0.8054
72387530|NCT02609828|144283485|SUPERIORITY||Odds Ratio (OR)|0.94||||0.9292|TWO_SIDED|95.0|0.22|3.98|||Regression, Logistic|||Week 1 Reduction \>=50%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||3.98|0.22|0.9292
72387531|NCT02609828|144283485|SUPERIORITY|||||||0.9565|||||||Regression, Logistic|||Week 1 Reduction \>=70%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||||0.9565
72387532|NCT02609828|144283485|SUPERIORITY||Odds Ratio (OR)|1.88||||0.1429|TWO_SIDED|95.0|0.81|4.36|||Regression, Logistic|||Week 2 Reduction \>=30%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||4.36|0.81|0.1429
72387533|NCT02609828|144283485|SUPERIORITY||Odds Ratio (OR)|5.19||||0.014||95.0|1.4|19.31|||Regression, Logistic|||Week 2 Reduction \>=50%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||19.31|1.40|0.0140
72387534|NCT02609828|144283485|SUPERIORITY|||||||0.945|||||||Regression, Logistic|||Week 2 Reduction \>=70%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||||0.9450
72387535|NCT02609828|144283485|SUPERIORITY|||||||0.9489|||||||Regression, Logistic|||Week 2 Reduction \>=90%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||||0.9489
72387536|NCT02609828|144283485|SUPERIORITY||Odds Ratio (OR)|1.63||||0.1932|TWO_SIDED|95.0|0.78|3.39|||Regression, Logistic|||Week 4 Reduction \>=30%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||3.39|0.78|0.1932
72387537|NCT02609828|144283485|SUPERIORITY||Odds Ratio (OR)|3.17||||0.0254|TWO_SIDED|95.0|1.15|8.74|||Regression, Logistic|||Week 4 Reduction \>=50%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||8.74|1.15|0.0254
72387538|NCT02609828|144283485|SUPERIORITY||Odds Ratio (OR)|5.0||||0.0455|TWO_SIDED|95.0|1.03|24.16|||Regression, Logistic|||Week 4 Reduction \>=70%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||24.16|1.03|0.0455
72496088|NCT05888103|144521919|SUPERIORITY||LS Mean Difference|0.68|||<|0.0001|TWO_SIDED|95.0|0.6|0.76|||ANCOVA|||||0.76|0.60|<0.0001
72496089|NCT05888103|144521920|SUPERIORITY||LS Mean Difference|3.01||||0.5877|TWO_SIDED|95.0|-7.88|13.91|||ANCOVA|||||13.91|-7.88|0.5877
72496090|NCT05888103|144521921|SUPERIORITY||LS Mean Difference|-7.96||||0.5019|TWO_SIDED|95.0|-31.17|15.26|||ANCOVA|||||15.26|-31.17|0.5019
72496091|NCT01916980|144521931|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Longitudinal Data Analysis|Model includes terms of visit, group and visit by group interaction; visit is treated as a categorical variable||Analysis of the change from Baseline in least squares (LS) mean for the Desloratadine: Eczema/Dermatitis group||||<0.001
72496092|NCT01916980|144521931|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Longitudinal Data Analysis|Model includes terms of visit, group and visit by group interaction; visit is treated as a categorical variable||Analysis of the change from Baseline in LS mean for the Desloratadine: Dermal Pruritus group||||<0.001
72496093|NCT02324270|144521937|EQUIVALENCE|If the 90% CI for the ratio of mean changes between test and reference products was contained within the interval, \[0.80,1.25\], then the products were considered to be equivalent.|Ratio|1.01|||||TWO_SIDED|90.0|0.94|1.08||||||||1.08|0.94|
72496094|NCT02324270|144521938|SUPERIORITY|||||||0.01|||||||ANCOVA|||||||0.01
72496095|NCT02324270|144521938|SUPERIORITY|||||||0.05|||||||ANCOVA|||||||0.05
72559206|NCT01634139|144648087|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.12|STANDARD_ERROR_OF_MEAN|0.072||0.0975|TWO_SIDED|95.0|-0.262|0.022|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 24||0.022|-0.262|0.0975
72440998|NCT05165485|144394825|SUPERIORITY||Mean Difference (Net)|-6.0|||||TWO_SIDED|95.0|-40.0|29.0||The familywise type 1 error rate is controlled at 0.05 by testing the primary and secondary endpoint hypotheses in sequence and stopping after the first failure to reject the null hypothesis. Accordingly, the p-value is not shown.|Mixed Models Analysis||Revefenacin - Tiotropium Least Squares Mean Difference|The null hypothesis was that the Revefenacin - Tiotropium Least Squares Mean Difference was zero and the alternative hypothesis was that it was nonzero.|The Revefenacin - Tiotropium Least Squares Mean Difference was estimated by fitting a repeated measures mixed model which included terms for participant, treatment, 6 categorical covariates, and 3 continuous covariates: baseline FEV1, screening FEV1, and baseline PIFR. The 6 categorical covariates were reversibility to ipratropium status (reversible/not reversible), smoking status (current/former), concomitant LABA or LABA/ICS use (Yes/No), GOLD airflow category (3/4, i.e., postipratropium FEV1 % predicted \< 30%/≥ 30%), sex (woman/man), and age group (\< 65/≥ 65).|29|-40|
72440999|NCT05165485|144394826|SUPERIORITY||Mean Difference (Net)|-41.0|||||TWO_SIDED|95.0|-118.0|35.0||The familywise type 1 error rate is controlled at 0.05 by testing the primary and secondary endpoint hypotheses in sequence and stopping after the first failure to reject the null hypothesis. Accordingly, the p-value is not shown.|Mixed Models Analysis||Revefenacin - Tiotropium Least Squares Mean Difference.|The null hypothesis was that the Revefenacin - Tiotropium Least Squares Mean Difference was zero and the alternative hypothesis was that it was nonzero.|The Revefenacin - Tiotropium Least Squares Mean Difference was estimated by fitting a repeated measures mixed model which included terms for participant, treatment, 6 categorical covariates, and 3 continuous covariates: baseline FVC, screening FVC, and baseline PIFR. The 6 categorical covariates were reversibility to ipratropium status (reversible/not reversible), smoking status (current/former), concomitant LABA or LABA/ICS use (Yes/No), GOLD airflow category (3/4, i.e., postipratropium FEV1 % predicted \< 30%/≥ 30%), sex (woman/man), and age group (\< 65/≥ 65).|35|-118|
72441000|NCT05165485|144394827|SUPERIORITY||Odds Ratio (OR)|0.6|||||TWO_SIDED|95.0|0.39|0.92||The familywise type 1 error rate is controlled at 0.05 by testing the primary and secondary endpoint hypotheses in sequence and stopping after the first failure to reject the null hypothesis. Accordingly, the p-value is not shown.|Regression, Logistic||The profile likelihood method was used to estimate the Revefenacin / Tiotropium responder OR.|The null hypothesis was that the Revefenacin / Tiotropium responder Odds Ratio was equal to 1 and the alternative hypothesis was that it was not equal to 1.|The Revefenacin / Tiotropium responder OR was estimated by fitting a logistic regression model which included terms for participant, treatment, 6 categorical covariates, and 3 continuous covariates: baseline FEV1, screening FEV1, and baseline PIFR. The 6 categorical covariates were reversibility to ipratropium status (reversible/not reversible), smoking status (current/former), concomitant LABA or LABA/ICS use (Yes/No), GOLD airflow category (3/4, i.e., postipratropium FEV1 % predicted \< 30%/≥ 30%), sex (woman/man), and age group (\< 65/≥ 65).|0.92|0.39|
72441001|NCT05165485|144394828|SUPERIORITY||Hazard Ratio (HR)|1.0|||||TWO_SIDED|95.0|0.69|1.45||The familywise type 1 error rate is controlled at 0.05 by testing the primary and secondary endpoint hypotheses in sequence and stopping after the first failure to reject the null hypothesis. Accordingly, the p-value is not shown.|Regression, Cox||The profile likelihood method was used to estimate the Revefenacin / Tiotropium HR.|The null hypothesis was that the Revefenacin / Tiotropium CompEx Event Hazard Ratio was equal to 1 and the alternative hypothesis was that it was not equal to 1.|The Revefenacin / Tiotropium HR was estimated by fitting a Cox proportional hazards model which included terms for participant, treatment, 6 categorical covariates, and 3 continuous covariates: baseline FEV1, screening FEV1, and baseline PIFR. The 6 categorical covariates were reversibility to ipratropium status (reversible/not reversible), smoking status (current/former), concomitant LABA or LABA/ICS use (Yes/No), GOLD airflow category (3/4, i.e., postipratropium FEV1 % predicted \< 30%/≥ 30%), sex (woman/man), and age group (\< 65/≥ 65).|1.45|0.69|
72441002|NCT03237481|144394830|SUPERIORITY||Least Squares Mean Difference (LSMD)|-81.43|STANDARD_ERROR_OF_MEAN|22.592|=|0.0004|TWO_SIDED|95.0|-125.83|-37.02|||ANOVA|||||-37.02|-125.83|= 0.0004
72441003|NCT03237481|144394831|SUPERIORITY||Least Squares Mean Difference (LSMD)|-72.49|STANDARD_ERROR_OF_MEAN|18.23|<|0.0001|TWO_SIDED|95.0|-108.32|-36.65|||ANOVA|||||-36.65|-108.32|< 0.0001
72441004|NCT03237481|144394832|SUPERIORITY||||||=|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||= 0.0001
72441005|NCT03237481|144394833|SUPERIORITY||Risk Difference (RD)|0.111|||=|0.0486|TWO_SIDED|95.0|0.003|0.218|||Fisher Exact|||||0.218|0.003|= 0.0486
72441006|NCT03237481|144394834|SUPERIORITY||||||=|0.024|||||||Wilcoxon (Mann-Whitney)|||||||= 0.024
72441007|NCT03112174|144394864|SUPERIORITY||Hazard Ratio (HR)|0.629||||0.0024|TWO_SIDED|95.0|0.465|0.85||P value is from stratified log-rank test.|Log Rank|||||0.850|0.465|0.0024
72441008|NCT03112174|144394870|SUPERIORITY||Rate Ratio|1.658||||0.0004|TWO_SIDED|95.0|1.24|2.218||Estimate and p-value for rate ratio are based on Cochran-Mantel-Haenszel (CMH) test adjusted for two randomization stratification factors: number of prior lines of therapy (1-2 vs \>=3) and TLS category (low risk vs increased risk) at randomization.|Cochran-Mantel-Haenszel||For rate ratio, numerator is Ibrutinib + Venetoclax arm and denominator is Ibrutinib + Placebo arm.|||2.218|1.240|0.0004
72441009|NCT03112174|144394871|SUPERIORITY||Rate Ratio|1.101||||0.1279|TWO_SIDED|95.0|0.973|1.247||Estimate and p-value for rate ratio are based on CMH test adjusted for two randomization stratification factors: number of prior lines of therapy (1-2 vs \>=3) and TLS category (low risk vs increased risk) at randomization.|Cochran-Mantel-Haenszel||For rate ratio, numerator is Ibrutinib + Venetoclax arm and denominator is Ibrutinib + Placebo arm.|||1.247|0.973|0.1279
72441010|NCT03112174|144394872|SUPERIORITY|||||||0.2028|||||||Fisher Exact|||Bone marrow aspirate||||0.2028
72441011|NCT03112174|144394872|SUPERIORITY|||||||0.0014|||||||Fisher Exact|||Peripheral blood||||0.0014
72441012|NCT03112174|144394873|SUPERIORITY||Hazard Ratio (HR)|0.832||||0.2669|TWO_SIDED|95.0|0.602|1.151||P value is from stratified log-rank test.|Log Rank||Hazard ratio is estimated using stratified Cox regression model with treatment as the only covariate.|||1.151|0.602|0.2669
72441013|NCT03112174|144394875|SUPERIORITY||Hazard Ratio (HR)|0.541||||0.0013|TWO_SIDED|95.0|0.369|0.792||P value is from stratified log-rank test.|Log Rank||Hazard ratio is estimated using stratified Cox regression model with treatment as the only covariate.|||0.792|0.369|0.0013
72441014|NCT03112174|144394890|SUPERIORITY||Hazard Ratio (HR)|1.169||||0.2861|TWO_SIDED|95.0|0.879|1.554||P value is from stratified log-rank test.|Log Rank|||||1.554|0.879|0.2861
72441015|NCT01534494|144394919|OTHER|Paired t-test||||||0.008|||||||t-test, 2 sided|Paired t-test for significance of change. t(8) = 3.477. P(2-sided) = 0.008||Single-group pre-post contrast||||0.008
72441016|NCT02374463|144394978|SUPERIORITY||||||<|0.05||||||P value not adjusted for multiple comparisons|t-test, 2 sided|||within group change was assessed||||<0.05
72441017|NCT02374463|144394979|SUPERIORITY||||||=|0.08||||||p value not adjusted for multiple comparisons|ANOVA|||||||=0.08
72441018|NCT02374463|144394980|SUPERIORITY||||||=|0.6|||||||ANOVA|not adjusted for multiple comparisons||||||=0.6
72441019|NCT02374463|144394981|SUPERIORITY|||||||0.84||||||Not adjusted for multiple comparisons|Chi-squared|exploratory aim prespecified.||||||0.84
72441020|NCT02374463|144394981|SUPERIORITY||||||=|0.4|||||||Chi-squared|||||||=0.4
72441021|NCT02374463|144394982|SUPERIORITY||||||=|0.3||||||not adjusted for multiple comparisons|ANOVA|||||||=0.3
72441022|NCT02374463|144394983|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<0.05
72441023|NCT01808339|144394993|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.077|||||TWO_SIDED|90.0|0.001|0.152|||||The estimated value represents the difference in Least Squares Means between FF 100 µg AM and Placebo (FF 100 µg AM minus Placebo).|||0.152|0.001|
72441024|NCT01808339|144394993|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.105|||||TWO_SIDED|90.0|0.029|0.18|||||The estimated value represents the difference in Least Squares Means between FF 100 µg PM and Placebo (FF 100 µg PM minus Placebo).|||0.180|0.029|
72441025|NCT01808339|144394993|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.028|||||TWO_SIDED|90.0|-0.102|0.045|||||The estimated value represents the difference in Least Squares Means between FF 100 µg AM and FF 100 µg PM (FF 100 µg AM minus FF 100 µg PM).|||0.045|-0.102|
72441026|NCT01643616|144395009|SUPERIORITY_OR_OTHER||Percentage Difference|33.0|||<|0.05|||||||Fisher Exact||For success rate without supplementation the difference between group US (94.9%) and group NS (61.9%) is 33%.|For sample size calculation we assumed a significance level of 0.05 and a success rate derived from clinical data of 75% in the nerve stimulation group and of 90% in the ultrasound group. With a group ratio of 1:1 and a power of 0.8, the required sample size was at least 226. For statistical analysis we used the exact Fisher test as a distribution-free, non-parametric test method.||||< 0.05
72619016|NCT00564070|144768450|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|20.7|||<|0.0001|TWO_SIDED|95.0|10.22|31.14|||Mixed Models Analysis||The Mean Difference was calculated as percent pill adherence via MEMs for the CBT-AD Arm minus the percent pill adherence for the Enhanced Treatment as Usual Arm.|Analyses are reported for the acute outcomes of MEMs monitoring (4 month). Higher percentages represent better adherence.||31.14|10.22|<0.0001
72441027|NCT01643616|144395010|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|22.9|||<|0.05|TWO_SIDED|95.0|13.6|31.1|||Log Rank|||We used the log-rank test to compare the onset times. The significance level was defined with p\<0.05.||31.1|13.6|< 0.05
72441028|NCT01643616|144395011|SUPERIORITY_OR_OTHER||Percentage Difference|26.2||||0.05|||||||Fisher Exact||For success rate with supplementation the difference between group US (98.2%) and group NS (72%) is 26.2%.|For sample size calculation we assumed a significance level of 0.05 and a success rate derived from clinical data of 75% in the nerve stimulation group and of 90% in the ultrasound group. With a group ratio of 1:1 and a power of 0.8, the required sample size was at least 226. For statistical analysis we used the exact Fisher test as a distribution-free, non-parametric test method.||||0.05
72441029|NCT02622568|144395012|NON_INFERIORITY|Veregen alone has efficacy compared to Veregen + cryotherapy|Mean Difference (Final Values)|1.556||||0.383|TWO_SIDED|||||Comparison at week 12|t-test, 2 sided|||||||0.383
72441030|NCT02622568|144395012|NON_INFERIORITY|Comparison at week 0|Mean Difference (Final Values)|-0.222||||0.81|TWO_SIDED||||||t-test, 2 sided|||||||0.81
72441031|NCT01854385|144395027|SUPERIORITY|||||||0.079|||||||Mixed Models Analysis|||||||.079
72441032|NCT04040296|144395060|SUPERIORITY||Difference in percentage|1.4||||0.28|TWO_SIDED|95.0|-1.1|3.8|||Cochran-Mantel-Haenszel||Difference between arms in the percentage of subjects with the primary outcome within 14 days of randomization.|||3.8|-1.1|0.28
72441033|NCT04040296|144395061|SUPERIORITY||Difference in percentage|9.5|||<|0.001|TWO_SIDED|95.0|8.1|11.0|||Van Elteren test||Difference between arms in the percentage of implemented recommendations with 24 hours of randomization.|Proportions were compared using Cochrane-Mantel Haenszel χ2 test, accounting for stratification by hospital site.||11|8.1|<.001
72441034|NCT04040296|144395062|SUPERIORITY||Difference in percentage|0.5||||0.65|TWO_SIDED|95.0|-1.6|2.6|||Van Elteren test||Difference between arms in the percentage of subjects with AKI progression within 14 days of randomization.|Proportions were compared using Cochrane-Mantel Haenszel χ2 test, accounting for stratification by hospital site.||2.6|-1.6|.65
72441035|NCT04040296|144395063|SUPERIORITY||Difference in percentage|0.1||||0.89|TWO_SIDED|95.0|-0.7|0.8|||Van Elteren test||Difference between arms in the percentage of subjects who received inpatient dialysis within 14 days of randomization.|Proportions were compared using Cochrane-Mantel Haenszel χ2 test, accounting for stratification by hospital site.||.8|-.7|.89
72441036|NCT04040296|144395064|SUPERIORITY||Difference in percentage|0.4||||0.72|TWO_SIDED|95.0|-1.5|2.1|||Van Elteren test||Difference between arms in the percentage of subjects with inpatient mortality within 14 days of randomization.|Proportions were compared using Cochrane-Mantel Haenszel χ2 test, accounting for stratification by hospital site.||2.1|-1.5|.72
72441037|NCT04040296|144395065|SUPERIORITY||Difference in percentage|1.9||||0.31|TWO_SIDED|95.0|-0.3|4.1|||Van Elteren test||Difference between arms in the percentage of subjects who received a kidney consult within 14 days of randomization.|Proportions were compared using Cochrane-Mantel Haenszel χ2 test, accounting for stratification by hospital site.||4.1|-.3|.31
72441038|NCT04040296|144395066|SUPERIORITY||Difference in percentage|-0.9||||0.17|TWO_SIDED|95.0|-2.3|0.4|||Van Elteren test||Difference between arms in the percentage of subjects discharged to hospice care within 14 days of randomization.|Proportions were compared using Cochrane-Mantel Haenszel χ2 test, accounting for stratification by hospital site.||.4|-2.3|.17
72441039|NCT03224390|144395081|SUPERIORITY||Instrumental variables estimate|0.41|||||TWO_SIDED|95.0|-0.03|0.85||||||||.85|-.03|
72441040|NCT03988023|144395088|SUPERIORITY|||||||0.32|||||||MMRM|||||||0.32
72441041|NCT03988023|144395089|SUPERIORITY|||||||0.3|||||||MMRM|||||||0.30
72441042|NCT00396084|144395093|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA|||Mean adjusted aAUC for all 4 treatment groups over the 7 days of study drug administration||||<0.001
72441043|NCT00396084|144395093|SUPERIORITY_OR_OTHER|||||||0.041|||||||Wilcoxon (Mann-Whitney)|||Day 1. Pooled sputum bacillary load data for patients in the 3 fluoroquinolones arms were combined and compared to that of patients in the INH arm.||||0.041
72559207|NCT01634139|144648087|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.182|STANDARD_ERROR_OF_MEAN|0.072||0.0116|TWO_SIDED|95.0|-0.323|-0.041|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 24||-0.041|-0.323|0.0116
72619017|NCT00564070|144768451|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.22|||=|0.002|TWO_SIDED|95.0|2.33|10.56|||Mixed Models Analysis|General linear model, controlling for baseline values.|The Mean Difference was calculated as MADRS unit scale for the CBT-AD Arm minus the MADRS unit scale for the Enhanced Treatment as Usual Arm.|Analyses are reported for the acute outcomes of depression as assessed on the MADRS at acute outcome.||10.56|2.33|=.002
72441044|NCT00396084|144395093|SUPERIORITY_OR_OTHER|||||||0.008||95.0|||||Wilcoxon (Mann-Whitney)|||Day 2. Pooled sputum bacillary load data for patients in the 3 fluoroquinolones arms were combined and compared to that of patients in the INH arm.||||0.008
72441045|NCT00396084|144395093|SUPERIORITY_OR_OTHER|||||||0.012||95.0|||||Wilcoxon (Mann-Whitney)|||Day 3. Pooled sputum bacillary load data for patients in the 3 fluoroquinolones arms were combined and compared to that of patients in the INH arm.||||0.012
72441046|NCT00396084|144395093|SUPERIORITY_OR_OTHER|||||||0.01||95.0|||||Wilcoxon (Mann-Whitney)|||Day 4. Pooled sputum bacillary load data for patients in the 3 fluoroquinolones arms were combined and compared to that of patients in the INH arm.||||0.01
72441047|NCT00396084|144395093|SUPERIORITY_OR_OTHER|||||||0.03||95.0|||||Wilcoxon (Mann-Whitney)|||Day 5. Pooled sputum bacillary load data for patients in the 3 fluoroquinolones arms were combined and compared to that of patients in the INH arm.||||0.03
72441048|NCT00396084|144395093|SUPERIORITY_OR_OTHER|||||||0.091||95.0|||||Wilcoxon (Mann-Whitney)|||Day 6. Pooled sputum bacillary load data for patients in the 3 fluoroquinolones arms were combined and compared to that of patients in the INH arm.||||0.091
72441049|NCT00396084|144395093|SUPERIORITY_OR_OTHER|||||||0.354||95.0|||||Wilcoxon (Mann-Whitney)|||Day 7. Pooled sputum bacillary load data for patients in the 3 fluoroquinolones arms were combined and compared to that of patients in the INH arm.||||0.354
72441050|NCT00396084|144395097|SUPERIORITY_OR_OTHER|||||||0.05|||||||ANOVA|||Mean values of EBA Days 0 to 2 for the 4 treatment groups were compared.||||0.05
72441051|NCT00396084|144395097|SUPERIORITY_OR_OTHER|||||||0.01|||||||Wilcoxon (Mann-Whitney)|||Two way comparison of INH against gatifloxacin using a simultaneous non-parametric procedure.||||0.01
72441052|NCT00396084|144395097|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||Wilcoxon (Mann-Whitney)|||Two way comparison of INH against moxifloxacin using a simultaneous non-parametric procedure.||||0.02
72441053|NCT00396084|144395097|SUPERIORITY_OR_OTHER|||||||0.14||95.0|||||Wilcoxon (Mann-Whitney)|||Two way comparison of INH against levofloxacin using a simultaneous non-parametric procedure.||||0.14
72441054|NCT00396084|144395098|SUPERIORITY_OR_OTHER|||||||0.51|||||||ANOVA|||Mean values of EBA Days 2 to 7 for the 4 treatment groups were compared.||||0.51
72441055|NCT00396084|144395098|SUPERIORITY_OR_OTHER|||||||0.16||95.0|||||ANOVA|||The rate of fall in sputum cfu for the 4 treatment groups between day 2 and day 7 of monotherapy was estimated by the slope of the linear regression obtained from fitting the 6 sputum cfu values corresponding to days 2 through 7.||||0.16
72441056|NCT00396084|144395098|SUPERIORITY_OR_OTHER|||||||0.036|||||||Wilcoxon (Mann-Whitney)|||EBA Days 2-7 for patients in the 3 fluoroquinolone groups were pooled and compared to bactericidal activity of patients in the INH arm.||||0.036
72441057|NCT00396084|144395099|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA|||Mean adjusted aAUC for all 3 treatment groups over the 7 days of study drug administration||||<0.001
72441058|NCT00396084|144395099|SUPERIORITY_OR_OTHER|||||||0.023|||||||Wilcoxon (Mann-Whitney)|||Day 1. Pooled sputum bacillary load data for patients in the linezolid arms were combined and compared to that of patients in the INH arm.||||0.023
72441059|NCT00396084|144395099|SUPERIORITY_OR_OTHER|||||||0.018||95.0|||||Wilcoxon (Mann-Whitney)|||Day 2. Pooled sputum bacillary load data for patients in the linezolid arms were combined and compared to that of patients in the INH arm.||||0.018
72441060|NCT00396084|144395099|SUPERIORITY_OR_OTHER|||||||0.03||95.0|||||Wilcoxon (Mann-Whitney)|||Day 3. Pooled sputum bacillary load data for patients in the linezolid arms were combined and compared to that of patients in the INH arm.||||0.03
72441061|NCT00396084|144395099|SUPERIORITY_OR_OTHER|||||||0.012||95.0|||||Wilcoxon (Mann-Whitney)|||Day 4. Pooled sputum bacillary load data for patients in the linezolid arms were combined and compared to that of patients in the INH arm.||||0.012
72619018|NCT00564070|144768452|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.74|||=|0.01|TWO_SIDED|95.0|0.16|1.32|||ANCOVA|using GLM|The Mean Difference was calculated as CGI unit scale for the Enhanced Treatment as Usual Arm minus the CGI unit scale for the CBT-AD Arm.|||1.32|.16|=.01
72441062|NCT00396084|144395099|SUPERIORITY_OR_OTHER|||||||0.003||95.0|||||Wilcoxon (Mann-Whitney)|||Day 5. Pooled sputum bacillary load data for patients in the linezolid arms were combined and compared to that of patients in the INH arm.||||0.003
72441063|NCT00396084|144395099|SUPERIORITY_OR_OTHER|||||||0.003||95.0|||||Wilcoxon (Mann-Whitney)|||Day 6. Pooled sputum bacillary load data for patients in the linezolid arms were combined and compared to that of patients in the INH arm.||||0.003
72441064|NCT00396084|144395099|SUPERIORITY_OR_OTHER|||||||0.004||95.0|||||Wilcoxon (Mann-Whitney)|||Day 7. Pooled sputum bacillary load data for patients in the linezolid arms were combined and compared to that of patients in the INH arm.||||0.004
72559208|NCT01634139|144648087|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.065|STANDARD_ERROR_OF_MEAN|0.073||0.3732|TWO_SIDED|95.0|-0.208|0.078|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 48||0.078|-0.208|0.3732
72559209|NCT01634139|144648087|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.093|STANDARD_ERROR_OF_MEAN|0.073||0.1985|TWO_SIDED|95.0|-0.236|0.049|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 48||0.049|-0.236|0.1985
72559210|NCT01634139|144648089|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.176|STANDARD_ERROR_OF_MEAN|0.072||0.0144|TWO_SIDED|95.0|0.035|0.316|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 24||0.316|0.035|0.0144
72559211|NCT01634139|144648089|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.127|STANDARD_ERROR_OF_MEAN|0.071||0.0747|TWO_SIDED|95.0|-0.013|0.267|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 24||0.267|-0.013|0.0747
72496096|NCT00680836|144521939|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3||||0.26|TWO_SIDED|95.0|-1.0|0.3|||t-test, 2 sided|||||0.3|-1.0|0.26
72559212|NCT01634139|144648089|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.021|STANDARD_ERROR_OF_MEAN|0.072||0.7654|TWO_SIDED|95.0|-0.163|0.12|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 48||0.120|-0.163|0.7654
72559213|NCT01634139|144648089|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.017|STANDARD_ERROR_OF_MEAN|0.072||0.8082|TWO_SIDED|95.0|-0.124|0.158|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 48||0.158|-0.124|0.8082
72387539|NCT02609828|144283485|SUPERIORITY|||||||0.9464|||||||Regression, Logistic|||Week 4 Reduction \>=90%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||||0.9464
72387540|NCT02609828|144283485|SUPERIORITY||Odds Ratio (OR)|1.83||||0.0969|TWO_SIDED|95.0|0.9|3.72|||Regression, Logistic|||Week 6 Reduction \>=30%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||3.72|0.90|0.0969
72387541|NCT02609828|144283485|SUPERIORITY||Odds Ratio (OR)|4.31||||0.0043|TWO_SIDED|95.0|1.58|11.74|||Regression, Logistic|||Week 6 Reduction \>=50%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||11.74|1.58|0.0043
72387542|NCT02609828|144283485|SUPERIORITY||Odds Ratio (OR)|5.49||||0.0352|TWO_SIDED|95.0|1.13|26.75|||Regression, Logistic|||Week 6 Reduction \>=70%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||26.75|1.13|0.0352
72387543|NCT02609828|144283485|SUPERIORITY|||||||0.9464|||||||Regression, Logistic|||Week 6 Reduction \>=90%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||||0.9464
72387544|NCT02609828|144283485|SUPERIORITY||Odds Ratio (OR)|1.71||||0.1471|TWO_SIDED|95.0|0.83|3.52|||Regression, Logistic|||Week 8 Reduction \>=30%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||3.52|0.83|0.1471
72387545|NCT02609828|144283485|SUPERIORITY||Odds Ratio (OR)|2.55||||0.0405|TWO_SIDED|95.0|1.04|6.22|||Regression, Logistic|||Week 8 Reduction \>=50%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||6.22|1.04|0.0405
72387546|NCT02609828|144283485|SUPERIORITY||Odds Ratio (OR)|3.21||||0.0993|TWO_SIDED|95.0|0.8|12.83|||Regression, Logistic|||Week 8 Reduction \>=70%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||12.83|0.80|0.0993
72387547|NCT02609828|144283485|SUPERIORITY||Odds Ratio (OR)|4.71||||0.1726|TWO_SIDED|95.0|0.51|43.64|||Regression, Logistic|||Week 8 Reduction \>=90%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||43.64|0.51|0.1726
72387548|NCT02609828|144283485|SUPERIORITY||Odds Ratio (OR)|1.84||||0.0918|TWO_SIDED|95.0|0.91|3.74|||Regression, Logistic|||Week 12 Reduction \>=30%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||3.74|0.91|0.0918
72387549|NCT02609828|144283485|SUPERIORITY||Odds Ratio (OR)|2.13||||0.0704|TWO_SIDED|95.0|0.94|4.82|||Regression, Logistic|||Week 12 Reduction \>=50%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||4.82|0.94|0.0704
72387550|NCT02609828|144283485|SUPERIORITY||Odds Ratio (OR)|1.67||||0.3569|TWO_SIDED|95.0|0.56|5.01|||Regression, Logistic|||Week 12 Reduction \>=70%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||5.01|0.56|0.3569
72387551|NCT02609828|144283485|SUPERIORITY||Odds Ratio (OR)|2.46||||0.3062|TWO_SIDED|95.0|0.44|13.79|||Regression, Logistic|||Week 12 Reduction \>=90%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||13.79|0.44|0.3062
72387552|NCT02609828|144283485|SUPERIORITY||Odds Ratio (OR)|1.84||||0.1058|TWO_SIDED|95.0|0.88|3.85|||Regression, Logistic|||Week 16 Reduction \>=30%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||3.85|0.88|0.1058
72387553|NCT02609828|144283485|SUPERIORITY||Odds Ratio (OR)|1.81||||0.1571|TWO_SIDED|95.0|0.79|4.14|||Regression, Logistic|||Week 16 Reduction \>=50%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||4.14|0.79|0.1571
72496097|NCT00680836|144521940|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.98|TWO_SIDED|95.0|0.0|0.5|||t-test, 2 sided|||||0.5|0.0|0.98
72496098|NCT00680836|144521941|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||0.78|TWO_SIDED|95.0|||||t-test, 2 sided|||||||0.78
72496099|NCT00680836|144521942|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.64|TWO_SIDED|95.0|-0.2|0.2|||Chi-squared|||||0.2|-0.2|0.64
72496100|NCT00680836|144521943|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.72|TWO_SIDED|95.0|-0.7|0.5|||t-test, 2 sided|||||0.5|-0.7|0.72
72387554|NCT02609828|144283485|SUPERIORITY||Odds Ratio (OR)|1.85||||0.2454|TWO_SIDED|95.0|0.65|5.24|||Regression, Logistic|||Week 16 Reduction \>=70%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||5.24|0.65|0.2454
72387555|NCT02609828|144283485|SUPERIORITY||Odds Ratio (OR)|0.91||||0.8867|TWO_SIDED|95.0|0.24|3.46|||Regression, Logistic|||Week 16 Reduction \>=90%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||3.46|0.24|0.8867
72387556|NCT02609828|144283485|SUPERIORITY||Odds Ratio (OR)|2.0||||0.0689|TWO_SIDED|95.0|0.95|4.21|||Regression, Logistic|||Week 24 Reduction \>=30%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||4.21|0.95|0.0689
72387557|NCT02609828|144283485|SUPERIORITY||Odds Ratio (OR)|2.3||||0.0568|TWO_SIDED|95.0|0.98|5.44|||Regression, Logistic|||Week 24 Reduction \>=50%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||5.44|0.98|0.0568
72387558|NCT02609828|144283485|SUPERIORITY||Odds Ratio (OR)|2.41||||0.1268|TWO_SIDED|95.0|0.78|7.46|||Regression, Logistic|||Week 24 Reduction \>=70%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||7.46|0.78|0.1268
72387559|NCT02609828|144283485|SUPERIORITY||Odds Ratio (OR)|1.23||||0.7971|TWO_SIDED|95.0|0.25|6.0|||Regression, Logistic|||Week 24 Reduction \>=90%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||6.00|0.25|0.7971
72387560|NCT02609828|144283486|SUPERIORITY||Odds Ratio (OR)|1.27||||0.6658|TWO_SIDED|95.0|0.43|3.7|||Regression, Logistic|||Week 1 Reduction \>=30%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||3.70|0.43|0.6658
72387561|NCT02609828|144283486|SUPERIORITY||Odds Ratio (OR)|3.07||||0.3443|TWO_SIDED|95.0|0.3|31.35|||Regression, Logistic|||Week 1 Reduction \>=50%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||31.35|0.30|0.3443
72387562|NCT02609828|144283486|SUPERIORITY|||||||0.9527|||||||Regression, Logistic|||Week 1 Reduction \>=70%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||||0.9527
72387563|NCT02609828|144283486|SUPERIORITY||Odds Ratio (OR)|2.25||||0.0757|TWO_SIDED|95.0|0.92|5.5|||Regression, Logistic|||Week 2 Reduction \>=30%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||5.50|0.92|0.0757
72387564|NCT02609828|144283486|SUPERIORITY||Odds Ratio (OR)|4.51||||0.0659|TWO_SIDED|95.0|0.91|22.42|||Regression, Logistic|||Week 2 Reduction \>=50%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||22.42|0.91|0.0659
72441065|NCT00396084|144395100|SUPERIORITY_OR_OTHER||||||<|0.01|||||||ANOVA|||Mean values of EBA Days 0 to 2 for the 3 treatments groups were compared.||||<0.01
72441066|NCT00396084|144395100|SUPERIORITY_OR_OTHER||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||Two way comparison of INH against Linezolid once daily using a simultaneous non-parametric procedure.||||<0.01
72441067|NCT00396084|144395100|SUPERIORITY_OR_OTHER||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||Mean EBA 0-2 of INH was compared to pooled Linezolid once daily and Linezolid twice daily results.||||<0.01
72441068|NCT00396084|144395103|SUPERIORITY_OR_OTHER|||||||0.25|||||||ANOVA|||Mean values EBA Days 2-7 for the 3 treatment groups were compared.||||0.25
72441069|NCT00396084|144395103|SUPERIORITY_OR_OTHER|||||||0.42|||||||ANOVA|||The rate of fall in sputum cfu for the 3 treatment groups between day 2 and day 7 of monotherapy was estimated by the slope of the linear regression obtained from fitting the 6 sputum cfu values corresponding to days 2 through 7.||||0.42
72441070|NCT00396084|144395103|SUPERIORITY_OR_OTHER|||||||0.14|||||||Wilcoxon (Mann-Whitney)|||EBA Days 2-7 for INH was compared to that of the pooled linezolid arms.||||0.14
72441071|NCT02708108|144395115|OTHER|Multivariable analysis|Odds Ratio (OR)|0.3||||0.02|TWO_SIDED|95.0|0.09|0.92||Reported as 1-sided p-value.|Regression, Logistic||Multivariable model includes age, BMI category, cytogenetic risk, ethnicity, sex|||0.92|0.09|0.02
72441072|NCT01736215|144395123|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.343||||0.266|TWO_SIDED|95.0|0.052|2.261||The binary logistic regression analysis was performed using a crude model between predictor variable endogenous EPO (EPO less than or equal to 45.2 and EPO greater than 45.3)|Regression, Logistic|||||2.261|0.052|0.266
72559214|NCT01634139|144648090|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.175|STANDARD_ERROR_OF_MEAN|0.085||0.0392|TWO_SIDED|95.0|0.009|0.341|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 24||0.341|0.009|0.0392
72441073|NCT01736215|144395124|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.125||||0.05|TWO_SIDED|95.0|0.016|0.999||The binary logistic regression analysis was performed using a crude model between predictor variable CRP (CRP less than or equal to 10.3 and CRP greater than 10.4)|Regression, Logistic|||||0.999|0.016|0.05
72441074|NCT00440011|144395173|SUPERIORITY_OR_OTHER|||||||0.024||95.0|||||ANCOVA|||||||0.024
72441075|NCT00212134|144395224|SUPERIORITY|||||||0.19|||||||Wilcoxon (Mann-Whitney)|||||||0.19
72441076|NCT00212134|144395225|SUPERIORITY|||||||0.54|||||||Wilcoxon (Mann-Whitney)|||||||0.54
72559215|NCT01634139|144648090|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.126|STANDARD_ERROR_OF_MEAN|0.084||0.1351|TWO_SIDED|95.0|-0.039|0.292|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 24||0.292|-0.039|0.1351
72387565|NCT02609828|144283486|SUPERIORITY|||||||0.938|||||||Regression, Logistic|||Week 2 Reduction \>=70%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||||0.9380
72387566|NCT02609828|144283486|SUPERIORITY|||||||0.9493|||||||Regression, Logistic|||Week 2 Reduction \>=90%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||||0.9493
72387567|NCT02609828|144283486|SUPERIORITY||Odds Ratio (OR)|2.02||||0.0914|TWO_SIDED|95.0|0.89|4.59|||Regression, Logistic|||Week 4 Reduction \>=30%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||4.59|0.89|0.0914
72387568|NCT02609828|144283486|SUPERIORITY||Odds Ratio (OR)|3.22||||0.0359|TWO_SIDED|95.0|1.08|9.61|||Regression, Logistic|||Week 4 Reduction \>=50%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||9.61|1.08|0.0359
72387569|NCT02609828|144283486|SUPERIORITY|||||||0.9538|||||||Regression, Logistic|||Week 4 Reduction \>=70%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||||0.9538
72387570|NCT02609828|144283486|SUPERIORITY|||||||0.9493|||||||Regression, Logistic|||Week 4 Reduction \>=90%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||||0.9493
72387571|NCT02609828|144283486|SUPERIORITY||Odds Ratio (OR)|2.66||||0.0143|TWO_SIDED|95.0|1.22|5.8|||Regression, Logistic|||Week 6 Reduction \>=30%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||5.80|1.22|0.0143
72387572|NCT02609828|144283486|SUPERIORITY||Odds Ratio (OR)|4.2||||0.0176|TWO_SIDED|95.0|1.28|13.74|||Regression, Logistic|||Week 6 Reduction \>=50%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||13.74|1.28|0.0176
72387573|NCT02609828|144283486|SUPERIORITY||Odds Ratio (OR)|3.53||||0.1298|TWO_SIDED|95.0|0.69|18.06|||Regression, Logistic|||Week 6 Reduction \>=70%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||18.06|0.69|0.1298
72441077|NCT00212134|144395226|OTHER|||||||0.82|||||||Chi-squared|||||||0.82
72441078|NCT00212134|144395227|SUPERIORITY|||||||0.03|||||||Fisher Exact|||||||0.03
72441079|NCT00212134|144395228|SUPERIORITY|||||||0.008|||||||Fisher Exact|||||||0.008
72441080|NCT00212134|144395229|SUPERIORITY||Mean Difference (Final Values)|15.7|||<|0.05|TWO_SIDED||||||t-test, 2 sided|||ITT analyses comparing parents of children randomized to receive an IOL to those left aphakic.||||<0.05
72441081|NCT00212134|144395231|SUPERIORITY||Mean Difference (Final Values)|7.295|||>|0.05|TWO_SIDED||||||t-test, 2 sided|||ITT comparison of mean PSI scores||||>0.05
72387574|NCT02609828|144283486|SUPERIORITY|||||||0.9493|||||||Regression, Logistic|||Week 6 Reduction \>=90%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||||0.9493
72441082|NCT00774852|144395249|SUPERIORITY_OR_OTHER|||||||0.85|||||||Chi-squared|Two-sided Pearson's chi-square test||||||0.85
72441083|NCT00774852|144395250|SUPERIORITY_OR_OTHER|||||||0.99|||||||Chi-squared|Two-sided Pearson's chi-square test||||||0.99
72441084|NCT00774852|144395251|SUPERIORITY_OR_OTHER|||||||0.54|TWO_SIDED||||||Chi-squared|Two-sided Pearson's chi-square test||||||0.54
72441085|NCT00774852|144395251|SUPERIORITY_OR_OTHER|||||||0.72|TWO_SIDED||||||Chi-squared|Two-sided Pearson's chi-square test||||||0.72
72441086|NCT00774852|144395252|SUPERIORITY_OR_OTHER|||||||0.54|TWO_SIDED||||||Chi-squared|Two-sided Pearson's chi-square test||||||0.54
72441087|NCT00774852|144395257|SUPERIORITY_OR_OTHER||||||>|0.99|TWO_SIDED||||||Chi-squared|Two-sided Pearson's chi-squared test||Comparison of Participants across groups who had negative anti-dsDNA at Week 104. Baseline is defined as the last measurement taken on or prior to the first day of dosing. Analysis is performed on participants with available data.||||>0.99
72441088|NCT00774852|144395258|SUPERIORITY_OR_OTHER||||||>|0.99|TWO_SIDED||||||Chi-squared|Two-sided Pearson's chi-squared test||Comparison of Participants across groups who had negative anti-dsDNA at Week 104. Baseline is defined as the last measurement taken on or prior to the first day of dosing. Analysis is performed on participants with available data.||||>0.99
72441089|NCT00774852|144395260|SUPERIORITY_OR_OTHER|||||||0.23|TWO_SIDED||||||Chi-squared|Pearson's||Comparison of groups with renal flare||||0.23
72441090|NCT00774852|144395260|SUPERIORITY_OR_OTHER|||||||0.61|TWO_SIDED||||||Chi-squared|Pearson's||Comparison of groups with renal flare||||0.61
72441091|NCT00774852|144395260|SUPERIORITY_OR_OTHER||||||>|0.99|TWO_SIDED||||||Chi-squared|Pearson's||Comparison of groups with at least one non-renal flare||||>0.99
72559216|NCT01634139|144648090|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.018|STANDARD_ERROR_OF_MEAN|0.085||0.8291|TWO_SIDED|95.0|-0.185|0.149|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 48||0.149|-0.185|0.8291
72387575|NCT02609828|144283486|SUPERIORITY||Odds Ratio (OR)|2.15||||0.0527|TWO_SIDED|95.0|0.99|4.67|||Regression, Logistic|||Week 8 Reduction \>=30%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||4.67|0.99|0.0527
72387576|NCT02609828|144283486|SUPERIORITY||Odds Ratio (OR)|2.69||||0.0457|TWO_SIDED|95.0|1.02|7.12|||Regression, Logistic|||Week 8 Reduction \>=50%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||7.12|1.02|0.0457
72387577|NCT02609828|144283486|SUPERIORITY||Odds Ratio (OR)|3.91||||0.0994|TWO_SIDED|95.0|0.77|19.76|||Regression, Logistic|||Week 8 Reduction \>=70%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||19.76|0.77|0.0994
72387578|NCT02609828|144283486|SUPERIORITY||Odds Ratio (OR)|0.65||||0.6977|TWO_SIDED|95.0|0.07|5.86|||Regression, Logistic|||Week 8 Reduction \>=90%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||5.86|0.07|0.6977
72387579|NCT02609828|144283486|SUPERIORITY||Odds Ratio (OR)|1.76||||0.146|TWO_SIDED|95.0|0.82|3.75|||Regression, Logistic|||Week 12 Reduction \>=30%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||3.75|0.82|0.1460
72387580|NCT02609828|144283486|SUPERIORITY||Odds Ratio (OR)|2.35||||0.0742|TWO_SIDED|95.0|0.92|6.01|||Regression, Logistic|||Week 12 Reduction \>=50%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||6.01|0.92|0.0742
72387581|NCT02609828|144283486|SUPERIORITY||Odds Ratio (OR)|1.44||||0.5565|TWO_SIDED|95.0|0.42|4.91|||Regression, Logistic|||Week 12 Reduction \>=70%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||4.91|0.42|0.5565
72387582|NCT02609828|144283486|SUPERIORITY||Odds Ratio (OR)|1.7||||0.5623|TWO_SIDED|95.0|0.28|10.35|||Regression, Logistic|||Week 12 Reduction \>=90%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||10.35|0.28|0.5623
72387583|NCT02609828|144283486|SUPERIORITY||Odds Ratio (OR)|2.86||||0.0116|TWO_SIDED|95.0|1.27|6.47|||Regression, Logistic|||Week 16 Reduction \>=30%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||6.47|1.27|0.0116
72387584|NCT02609828|144283486|SUPERIORITY||Odds Ratio (OR)|2.34||||0.0615|TWO_SIDED|95.0|0.96|5.7|||Regression, Logistic|||Week 16 Reduction \>=50%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||5.70|0.96|0.0615
72387585|NCT02609828|144283486|SUPERIORITY||Odds Ratio (OR)|1.68||||0.3316|TWO_SIDED|95.0|0.59|4.8|||Regression, Logistic|||Week 16 Reduction \>=70%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||4.80|0.59|0.3316
72387586|NCT02609828|144283486|SUPERIORITY||Odds Ratio (OR)|1.01||||0.9946|TWO_SIDED|95.0|0.19|5.33|||Regression, Logistic|||Week 16 Reduction \>=90%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||5.33|0.19|0.9946
72387587|NCT02609828|144283486|SUPERIORITY||Odds Ratio (OR)|2.99||||0.0083|TWO_SIDED|95.0|1.33|6.76|||Regression, Logistic|||Week 24 Reduction \>=30%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||6.76|1.33|0.0083
72387588|NCT02609828|144283486|SUPERIORITY||Odds Ratio (OR)|2.42||||0.0513|TWO_SIDED|95.0|1.0|5.88|||Regression, Logistic|||Week 24 Reduction \>=50%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||5.88|1.00|0.0513
72387589|NCT02609828|144283486|SUPERIORITY||Odds Ratio (OR)|2.48||||0.1528|TWO_SIDED|95.0|0.71|8.58|||Regression, Logistic|||Week 24 Reduction \>=70%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||8.58|0.71|0.1528
72441092|NCT00774852|144395260|SUPERIORITY_OR_OTHER||||||>|0.99|TWO_SIDED||||||Chi-squared|Pearson's||Comparison of groups with at least one non-renal flare||||>0.99
72441093|NCT00774852|144395265|SUPERIORITY_OR_OTHER|||||||0.79|TWO_SIDED|||||P-value compares actual values between experimental and control groups at Week 52 and is derived from two-sided t-test from and ANCOVA model that adjusts for baseline values.|ANCOVA|||||||0.79
72441094|NCT00774852|144395265|SUPERIORITY_OR_OTHER|||||||0.74|TWO_SIDED|||||P-value compares actual values between experimental and control groups at Week 52 and is derived from two-sided t-test from and ANCOVA model that adjusts for baseline values.|ANCOVA|||||||0.74
72441095|NCT00774852|144395266|SUPERIORITY_OR_OTHER|||||||0.43|TWO_SIDED||||||Chi-squared|Pearson's||Comparison of groups for Pneumococcal vaccines||||0.43
72441096|NCT00774852|144395266|SUPERIORITY_OR_OTHER|||||||0.99|TWO_SIDED||||||Chi-squared|Pearson's||Comparison of groups for Tetanus Toxoid vaccines||||0.99
72441097|NCT04870645|144395282|OTHER||||||<|0.05|||||||Statistical Significance|||||||< 0.05
72441098|NCT06336629|144395306|SUPERIORITY||two-sided|100.0|||||TWO_SIDED|95.0||||||||||||
72441099|NCT06336629|144395307|SUPERIORITY|||||||0.008|||||||Wilcoxon (Mann-Whitney)|||||||0.008
72441100|NCT06336629|144395308|SUPERIORITY|||||||0.007|||||||Wilcoxon rank-sum test|||||||0.007
72441101|NCT06336629|144395309|SUPERIORITY|||||||0.009|||||||Wilcoxon rank sum test|||||||0.009
72441102|NCT06336629|144395310|SUPERIORITY|||||||0.037||||||P-value from Baseline at Week 16|Wilcoxon signed rank|P-value from Baseline at Week 16||||||0.037
72441103|NCT06336629|144395312|SUPERIORITY|||||||1||||||P-value from Baseline at Week 16|Wilcoxon signed rank|||||||1
72441104|NCT06336629|144395313|SUPERIORITY|||||||1||||||P-value from Baseline at Week 16|Wilcoxon signed rank|||||||1
72441105|NCT04922021|144395334|SUPERIORITY|Two-sided hypotheses were tested based on the pre-specified primary analysis for the primary estimand. The primary estimand used a hypothetical strategy evaluating the treatment difference as if all subjects adhered to the treatment regimen, i.e. they did not discontinue IMP permanently, did not initiate rescue treatment, or did not have more than one missed treatment dose related to COVID-19.|Mean Difference (Net)|-11.8||||0.003|TWO_SIDED|95.0|-19.6|-4.1||The type I error rate of the two-sided hypothesis test was controlled at the 5% significance level.|ANCOVA|ANCOVA model: Change in EASI = Treatment + Region + Baseline EASI. Missing values and data 'treated as missing' were imputed using MI assuming MAR.|Estimates of difference in LS-means and associated standard errors from the analyses were combined using Rubin's rule to provide the overall pooled estimate and associated standard error. LS-means was estimated using the observed margins for the FAS.|||-4.1|-19.6|0.003
72441106|NCT01285999|144395357|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.29||||0.05|TWO_SIDED|95.0|-0.37|-0.21||p-value has not been adjusted.|t-test, 2 sided|No adjustment.||H0: μt - μc = 0 H1: μt - μc ≠ 0 where μt and μc are the mean 9-month in-stent late loss values for the subjects in the PROMUS Element test and TAXUS Liberté control treatment groups, respectively.||-0.21|-0.37|0.05
72441107|NCT05286385|144395403|NON_INFERIORITY|Non-inferiority margin -10%|Mean Difference (Final Values)|-3.0|STANDARD_DEVIATION|4.59|||TWO_SIDED|95.0|-6.29|0.29||||||||0.29|-6.29|
72441108|NCT05286385|144395404|NON_INFERIORITY|Non-inferiority margin -10%|Mean Difference (Final Values)|-2.3|STANDARD_DEVIATION|8.03|||TWO_SIDED|95.0|-8.04|3.44||||||||3.44|-8.04|
72441109|NCT05286385|144395405|NON_INFERIORITY|Non-inferiority margin -10%|Mean Difference (Final Values)|0.3|STANDARD_DEVIATION|4.55|||TWO_SIDED|95.0|-2.95|3.55||||||||3.55|-2.95|
72441110|NCT04188379|144395517|SUPERIORITY||Odds Ratio (OR)|4.884||||0.0316|TWO_SIDED|95.0|1.007|43.591|||Cochran-Mantel-Haenszel|||||43.591|1.007|0.0316
72441111|NCT04188379|144395518|SUPERIORITY||Median Difference (Net)|1.0||||0.0009|TWO_SIDED|95.0|0.0|4.0|||Wilcoxon (Mann-Whitney)|||||4.000|0.000|0.0009
72441112|NCT04188379|144395519|SUPERIORITY||Odds Ratio (OR)|5.224||||0.0108|TWO_SIDED|95.0|1.268|26.268|||Cochran-Mantel-Haenszel|||||26.268|1.268|0.0108
72441113|NCT04188379|144395520|SUPERIORITY||Rate Ratio|0.958||||0.8287|TWO_SIDED|95.0|0.651|1.41|||Wald Test|||||1.41|0.651|0.8287
72441114|NCT04188379|144395521|SUPERIORITY||Odds Ratio (OR)|4.354||||0.0265|TWO_SIDED|95.0|1.048|22.865|||Cochran-Mantel-Haenszel|||||22.865|1.0480|0.0265
72441115|NCT02566902|144395525|SUPERIORITY|||||||0.04|||||||t-test, 2 sided|||||||0.04
72441116|NCT02566902|144395526|SUPERIORITY|||||||0.29|||||||Wilcoxon (Mann-Whitney)|||||||0.29
72441117|NCT02566902|144395527|SUPERIORITY|||||||0.97|||||||Wilcoxon (Mann-Whitney)|||||||0.97
72441118|NCT02566902|144395528|SUPERIORITY|||||||0.96|||||||Chi-squared|||||||0.96
72441119|NCT02566902|144395529|SUPERIORITY|||||||0.99|||||||t-test, 2 sided|||||||0.99
72441120|NCT02566902|144395530|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.00
72441121|NCT05773313|144395541|SUPERIORITY||||||>|0.999|||||||Wilcoxon (Mann-Whitney)|||Food Insecurity||||>0.999
72441122|NCT05773313|144395541|SUPERIORITY|||||||0.25|||||||Wilcoxon (Mann-Whitney)|||Financial Insecurity||||0.250
72441123|NCT05773313|144395541|SUPERIORITY||||||>|0.999|||||||Wilcoxon (Mann-Whitney)|||Social Isolation||||>0.999
72441124|NCT05773313|144395541|SUPERIORITY||||||>|0.999|||||||Wilcoxon (Mann-Whitney)|||Physical Inactivity||||>0.999
72441125|NCT05773313|144395541|SUPERIORITY||||||>|0.999|||||||Wilcoxon (Mann-Whitney)|||Disability||||>0.999
72441126|NCT05773313|144395542|SUPERIORITY|||||||0.461|||||||Wilcoxon (Mann-Whitney)|||||||0.461
72441127|NCT05773313|144395543|SUPERIORITY||||||>|0.999|||||||Wilcoxon (Mann-Whitney)|||||||>0.999
72441128|NCT05773313|144395544|SUPERIORITY|||||||0.438|||||||Wilcoxon (Mann-Whitney)|||||||0.438
72441129|NCT05773313|144395545|SUPERIORITY|||||||0.08|||||||Wilcoxon (Mann-Whitney)|||||||0.080
72441130|NCT02748317|144395546|OTHER|1 group t-test no comparison group|||||=|0.219||||||P-value is not adjusted|t-test, 2 sided|||||||=0.219
72441131|NCT00802464|144395556|OTHER||Fold increase|5.21|||||TWO_SIDED|95.0|3.89|6.98||||||Fold increase in frequency of gE-specific CD4+ T-cells secreting at least 2 different immunological activation markers among IFN-γ, IL-2, TNF-α and CD40L for GSK1437173A Formulation 1 over GSK1437173A Formulation 3 Group.||6.98|3.89|
72441132|NCT00802464|144395556|OTHER||Fold increase|4.02|||||TWO_SIDED|95.0|3.0|5.4||||||Fold increase in frequency of gE-specific CD4+ T-cells secreting at least 2 different immunological activation markers among IFN-γ, IL-2, TNF-α and CD40L for GSK1437173A Formulation 2 over GSK1437173A Formulation 3 Group.||5.4|3|
72496101|NCT00680836|144521944|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0||||0.86|TWO_SIDED|95.0|-0.5|0.6|||t-test, 2 sided|||||0.6|-0.5|0.86
72496102|NCT03968419|144521963|OTHER||Mean Difference (Final Values)|0.5|||||TWO_SIDED|95.0|-25.56|21.23||||||Difference in MPR rate||21.23|-25.56|
72559217|NCT01634139|144648090|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.004|STANDARD_ERROR_OF_MEAN|0.085||0.9655|TWO_SIDED|95.0|-0.163|0.171|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 48||0.171|-0.163|0.9655
72559218|NCT01634139|144648091|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.191|STANDARD_ERROR_OF_MEAN|0.077||0.0139|TWO_SIDED|95.0|0.039|0.343|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 24||0.343|0.039|0.0139
72387590|NCT02609828|144283486|SUPERIORITY||Odds Ratio (OR)|1.41||||0.7251|TWO_SIDED|95.0|0.21|9.65|||Regression, Logistic|||Week 24 Reduction \>=90%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||9.65|0.21|0.7251
72387591|NCT02609828|144283487|SUPERIORITY||Difference in LS mean|-0.04|STANDARD_ERROR_OF_MEAN|0.12||0.7045|TWO_SIDED|95.0|-0.28|0.19|||ANCOVA|||Change at Week 2: ANCOVA model for imputed datasets included treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and baseline global assessment score, baseline average pain intensity at the index bone metastasis cancer pain site, and baseline opioid dose as covariates.||0.19|-0.28|0.7045
72387592|NCT02609828|144283487|SUPERIORITY||Difference in LS mean|-0.3|STANDARD_ERROR_OF_MEAN|0.14||0.0402|TWO_SIDED|95.0|-0.59|-0.01|||ANCOVA|||Change at Week 4: ANCOVA model for imputed datasets included treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and baseline global assessment score, baseline average pain intensity at the index bone metastasis cancer pain site, and baseline opioid dose as covariates.||-0.01|-0.59|0.0402
72387593|NCT02609828|144283487|SUPERIORITY||Difference in LS mean|-0.33|STANDARD_ERROR_OF_MEAN|0.17||0.0637|TWO_SIDED|95.0|-0.67|0.02|||ANCOVA|||Change at Week 8: ANCOVA model for imputed datasets included treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and baseline global assessment score, baseline average pain intensity at the index bone metastasis cancer pain site, and baseline opioid dose as covariates.||0.02|-0.67|0.0637
72387594|NCT02609828|144283487|SUPERIORITY||Difference in LS mean|-0.16|STANDARD_ERROR_OF_MEAN|0.18||0.3804|TWO_SIDED|95.0|-0.53|0.2|||ANCOVA|||Change at Week 16: ANCOVA model for imputed datasets included treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and baseline global assessment score, baseline average pain intensity at the index bone metastasis cancer pain site, and baseline opioid dose as covariates.||0.20|-0.53|0.3804
72387595|NCT02609828|144283487|SUPERIORITY||Difference in LS mean|-0.1|STANDARD_ERROR_OF_MEAN|0.18||0.5894|TWO_SIDED|95.0|-0.47|0.27|||ANCOVA|||Change at Week 24: ANCOVA model for imputed datasets included treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and baseline global assessment score, baseline average pain intensity at the index bone metastasis cancer pain site, and baseline opioid dose as covariates.||0.27|-0.47|0.5894
72387596|NCT02609828|144283488|SUPERIORITY||Odds Ratio (OR)|0.38||||0.2033|TWO_SIDED|95.0|0.09|1.69|||Regression, Logistic|||Week 2: Logistic regression model included baseline PGA-CP, baseline average pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||1.69|0.09|0.2033
72559219|NCT01634139|144648091|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.125|STANDARD_ERROR_OF_MEAN|0.077||0.1043|TWO_SIDED|95.0|-0.026|0.276|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 24||0.276|-0.026|0.1043
72559220|NCT01634139|144648091|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.035|STANDARD_ERROR_OF_MEAN|0.078||0.6547|TWO_SIDED|95.0|-0.118|0.187|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 48||0.187|-0.118|0.6547
72559221|NCT01634139|144648091|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.07|STANDARD_ERROR_OF_MEAN|0.077||0.3648|TWO_SIDED|95.0|-0.082|0.222|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 48||0.222|-0.082|0.3648
72387597|NCT02609828|144283488|SUPERIORITY||Odds Ratio (OR)|1.18||||0.7627|TWO_SIDED|95.0|0.41|3.41|||Regression, Logistic|||Week 4: Logistic regression model included baseline PGA-CP, baseline average pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||3.41|0.41|0.7627
72387598|NCT02609828|144283488|SUPERIORITY||Odds Ratio (OR)|1.23||||0.6894|TWO_SIDED|95.0|0.44|3.43|||Regression, Logistic|||Week 8: Logistic regression model included baseline PGA-CP, baseline average pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||3.43|0.44|0.6894
72387599|NCT02609828|144283488|SUPERIORITY||Odds Ratio (OR)|1.34||||0.5905|TWO_SIDED|95.0|0.47|3.83|||Regression, Logistic|||Week 16: Logistic regression model included baseline PGA-CP, baseline average pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||3.83|0.47|0.5905
72387600|NCT02609828|144283488|SUPERIORITY||Odds Ratio (OR)|1.12||||0.8354|TWO_SIDED|95.0|0.38|3.35|||Regression, Logistic|||Week 24: Logistic regression model included baseline PGA-CP, baseline average pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||3.35|0.38|0.8354
72496103|NCT00445302|144521992|SUPERIORITY_OR_OTHER||Ratio of least squares means (%)|87.09|||||TWO_SIDED|90.0|63.59|119.26||||||||119.26|63.59|
72496104|NCT00445302|144521992|SUPERIORITY_OR_OTHER||Ratio of least squares means(%)|106.6||||||90.0|78.99|143.87||||||||143.87|78.99|
72496105|NCT00445302|144521992|SUPERIORITY_OR_OTHER||Ratio of least squares means (%)|106.76||||||90.0|79.11|144.08||||||||144.08|79.11|
72496106|NCT00445302|144521995|SUPERIORITY_OR_OTHER||Ratio of least squares means (%)|121.74||||||90.0|91.86|161.43||||||||161.43|91.86|
72496107|NCT00445302|144521995|SUPERIORITY_OR_OTHER||Ratio of least squares means (%)|151.44||||||90.0|115.78|198.09||||||||198.09|115.78|
72559222|NCT01634139|144648092|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.166|STANDARD_ERROR_OF_MEAN|0.074||0.0256|TWO_SIDED|95.0|0.02|0.312|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 24||0.312|0.020|0.0256
72559223|NCT01634139|144648092|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.141|STANDARD_ERROR_OF_MEAN|0.074||0.0561|TWO_SIDED|95.0|-0.004|0.286|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 24||0.286|-0.004|0.0561
72559224|NCT01634139|144648092|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.061|STANDARD_ERROR_OF_MEAN|0.075||0.4127|TWO_SIDED|95.0|-0.208|0.085|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 48||0.085|-0.208|0.4127
72559225|NCT01634139|144648092|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.01|STANDARD_ERROR_OF_MEAN|0.074||0.8922|TWO_SIDED|95.0|-0.136|0.156|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 48||0.156|-0.136|0.8922
72387601|NCT02609828|144283491|SUPERIORITY||Difference in LS mean|-0.05|STANDARD_ERROR_OF_MEAN|0.22||0.8069|TWO_SIDED|95.0|-0.49|0.38|||Mixed Models Analysis|||Week 2 Frequency Composite Score: Mixed model for repeated measurements (MMRM) model includes time (study week), treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and treatment\*time interaction, baseline OR-SDS frequency scores, and baseline average pain intensity at the index bone metastasis cancer pain site as covariates.||0.38|-0.49|0.8069
72387602|NCT02609828|144283491|SUPERIORITY||Difference in LS mean|0.06|STANDARD_ERROR_OF_MEAN|0.17||0.7127|TWO_SIDED|95.0|-0.28|0.41|||Mixed Models Analysis|||Week 4 Frequency Composite Score: MMRM model includes time (study week), treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and treatment\*time interaction, baseline OR-SDS frequency scores, and baseline average pain intensity at the index bone metastasis cancer pain site as covariates.||0.41|-0.28|0.7127
72496108|NCT00445302|144521995|SUPERIORITY_OR_OTHER||Ratio of least squares means (%)|169.51||||||90.0|129.59|221.72||||||||221.72|129.59|
72387603|NCT02609828|144283491|SUPERIORITY||Difference in LS mean|-0.17|STANDARD_ERROR_OF_MEAN|0.2||0.3933|TWO_SIDED|95.0|-0.57|0.23|||Mixed Models Analysis|||Week 8 Frequency Composite Score: MMRM model includes time (study week), treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and treatment\*time interaction, baseline OR-SDS frequency scores, and baseline average pain intensity at the index bone metastasis cancer pain site as covariates.||0.23|-0.57|0.3933
72387604|NCT02609828|144283491|SUPERIORITY||Difference in LS mean|-0.15|STANDARD_ERROR_OF_MEAN|0.28||0.5869|TWO_SIDED|95.0|-0.71|0.41|||Mixed Models Analysis|||Week 16 Frequency Composite Score: MMRM model includes time (study week), treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and treatment\*time interaction, baseline OR-SDS frequency scores, and baseline average pain intensity at the index bone metastasis cancer pain site as covariates.||0.41|-0.71|0.5869
72559226|NCT01634139|144648094|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.009|STANDARD_ERROR_OF_MEAN|0.036||0.7931|TWO_SIDED|95.0|-0.08|0.061|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 24||0.061|-0.080|0.7931
72559227|NCT01634139|144648094|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.075|STANDARD_ERROR_OF_MEAN|0.036||0.0369|TWO_SIDED|95.0|-0.145|-0.005|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 24||-0.005|-0.145|0.0369
72559228|NCT01634139|144648094|SUPERIORITY_OR_OTHER||Median Difference (Net)|-0.03|STANDARD_ERROR_OF_MEAN|0.036||0.4086|TWO_SIDED|95.0|-0.101|0.041|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 48||0.041|-0.101|0.4086
72559229|NCT01634139|144648094|SUPERIORITY_OR_OTHER||Median Difference (Net)|-0.026|STANDARD_ERROR_OF_MEAN|0.036||0.4714|TWO_SIDED|95.0|-0.097|0.045|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 48||0.045|-0.097|0.4714
72619019|NCT00564070|144768453|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|22.3|STANDARD_ERROR_OF_MEAN|7.0|=|0.002|TWO_SIDED|95.0|8.6|36.1|||Mixed Models Analysis|||We hypothesized that differences in glucose monitoring adherence would continue to be superior in the CBT-AD condition compared to ETAU||36.1|8.6|=.002
72619020|NCT00564070|144768454|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.3|STANDARD_ERROR_OF_MEAN|5.0|=|0.001|TWO_SIDED|95.0|6.5|26.1|||Mixed Models Analysis|||We hypothesized that the CBT-AD condition would maintain higher medication adherence over follow up compared to ETAU||26.1|6.5|=.001
72387605|NCT02609828|144283491|SUPERIORITY||Difference in LS mean|-0.42|STANDARD_ERROR_OF_MEAN|0.3||0.1814|TWO_SIDED|95.0|-1.05|0.21|||Mixed Models Analysis|||Week 24 Frequency Composite Score: MMRM model includes time (study week), treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and treatment\*time interaction, baseline OR-SDS frequency scores, and baseline average pain intensity at the index bone metastasis cancer pain site as covariates.||0.21|-1.05|0.1814
72441133|NCT00802464|144395556|OTHER||Fold increase|1.3|||||TWO_SIDED|95.0|1.07|1.58||||||Fold increase in frequency of gE-specific CD4+ T-cells secreting at least 2 different immunological activation markers among IFN-γ, IL-2, TNF-α and CD40L for GSK1437173A Formulation 1 over GSK1437173A Formulation 2 Group.||1.58|1.07|
72441134|NCT00802464|144395557|OTHER||Fold increase|2.12|||||TWO_SIDED|95.0|1.67|2.69||||||Fold increase in frequency of gE-specific CD4+ T-cells secreting at least 2 different immunological activation markers among IFN-γ, IL-2, TNF-α and CD40L for GSK1437173A Formulation 1 over GSK1437173A Formulation 3 Group.||2.69|1.67|
72441135|NCT00802464|144395557|OTHER||Fold increase|1.63|||||TWO_SIDED|95.0|1.28|2.07||||||Fold increase in frequency of gE-specific CD4+ T-cells secreting at least 2 different immunological activation markers among IFN-γ, IL-2, TNF-α and CD40L for GSK1437173A Formulation 2 over GSK1437173A Formulation 3 Group.||2.07|1.28|
72559230|NCT01634139|144648095|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.001|STANDARD_ERROR_OF_MEAN|0.047||0.988|TWO_SIDED|95.0|-0.091|0.092|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 24||0.092|-0.091|0.9880
72559231|NCT01634139|144648095|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.082|STANDARD_ERROR_OF_MEAN|0.046||0.0794|TWO_SIDED|95.0|-0.173|0.01|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 24||0.010|-0.173|0.0794
72387606|NCT02609828|144283491|SUPERIORITY||Difference in LS mean|0.16|STANDARD_ERROR_OF_MEAN|0.15||0.2822|TWO_SIDED|95.0|-0.14|0.46|||Mixed Models Analysis|||Week 2 Severity Composite Score: MMRM model includes time (study week), treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and treatment\*time interaction, baseline OR-SDS severity scores, and baseline average pain intensity at the index bone metastasis cancer pain site as covariates.||0.46|-0.14|0.2822
72387607|NCT02609828|144283491|SUPERIORITY||Difference in LS mean|0.09|STANDARD_ERROR_OF_MEAN|0.16||0.5795|TWO_SIDED|95.0|-0.23|0.41|||Mixed Models Analysis|||Week 4 Severity Composite Score: MMRM model includes time (study week), treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and treatment\*time interaction, baseline OR-SDS severity scores, and baseline average pain intensity at the index bone metastasis cancer pain site as covariates.||0.41|-0.23|0.5795
72387608|NCT02609828|144283491|SUPERIORITY||Difference in LS mean|-0.1|STANDARD_ERROR_OF_MEAN|0.16||0.5486|TWO_SIDED|95.0|-0.42|0.22|||Mixed Models Analysis|||Week 8 Severity Composite Score: MMRM model includes time (study week), treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and treatment\*time interaction, baseline OR-SDS severity scores, and baseline average pain intensity at the index bone metastasis cancer pain site as covariates.||0.22|-0.42|0.5486
72387609|NCT02609828|144283491|SUPERIORITY||Difference in LS mean|0.2|STANDARD_ERROR_OF_MEAN|0.22||0.3692|TWO_SIDED|95.0|-0.24|0.63|||Mixed Models Analysis|||Week 16 Severity Composite Score: MMRM model includes time (study week), treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and treatment\*time interaction, baseline OR-SDS severity scores, and baseline average pain intensity at the index bone metastasis cancer pain site as covariates.||0.63|-0.24|0.3692
72387610|NCT02609828|144283491|SUPERIORITY||Difference in LS mean|0.17|STANDARD_ERROR_OF_MEAN|0.23||0.4724|TWO_SIDED|95.0|-0.3|0.63|||Mixed Models Analysis|||Week 24 Severity Composite Score: MMRM model includes time (study week), treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and treatment\*time interaction, baseline OR-SDS severity scores, and baseline average pain intensity at the index bone metastasis cancer pain site as covariates.||0.63|-0.30|0.4724
72387611|NCT02609828|144283491|SUPERIORITY||Difference in LS mean|0.17|STANDARD_ERROR_OF_MEAN|0.23||0.477|TWO_SIDED|95.0|-0.3|0.64|||Mixed Models Analysis|||Week 2 Distress Composite Score: MMRM model includes time (study week), treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and treatment\*time interaction, baseline OR-SDS distress scores, and baseline average pain intensity at the index bone metastasis cancer pain site as covariates.||0.64|-0.30|0.4770
72387612|NCT02609828|144283491|SUPERIORITY||Difference in LS mean|0.0|STANDARD_ERROR_OF_MEAN|0.18||0.9791|TWO_SIDED|95.0|-0.38|0.37|||Mixed Models Analysis|||Week 4 Distress Composite Score: MMRM model includes time (study week), treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and treatment\*time interaction, baseline OR-SDS distress scores, and baseline average pain intensity at the index bone metastasis cancer pain site as covariates.||0.37|-0.38|0.9791
72387613|NCT02609828|144283491|SUPERIORITY||Difference in LS mean|0.23|STANDARD_ERROR_OF_MEAN|0.25||0.3574|TWO_SIDED|95.0|-0.27|0.74|||Mixed Models Analysis|||Week 8 Distress Composite Score: MMRM model includes time (study week), treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and treatment\*time interaction, baseline OR-SDS distress scores, and baseline average pain intensity at the index bone metastasis cancer pain site as covariates.||0.74|-0.27|0.3574
72387614|NCT02609828|144283491|SUPERIORITY||Difference in LS mean|0.17|STANDARD_ERROR_OF_MEAN|0.29||0.5607|TWO_SIDED|95.0|-0.77|0.42|||Mixed Models Analysis|||Week 16 Distress Composite Score: MMRM model includes time (study week), treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and treatment\*time interaction, baseline OR-SDS distress scores, and baseline average pain intensity at the index bone metastasis cancer pain site as covariates.||0.42|-0.77|0.5607
72559232|NCT01634139|144648095|SUPERIORITY_OR_OTHER||Median Difference (Net)|-0.053|STANDARD_ERROR_OF_MEAN|0.047||0.2623|TWO_SIDED|95.0|-0.145|0.04|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 48||0.040|-0.145|0.2623
72387615|NCT02609828|144283491|SUPERIORITY||Difference in LS mean|-0.1|STANDARD_ERROR_OF_MEAN|0.28||0.7143|TWO_SIDED|95.0|-0.68|0.47|||Mixed Models Analysis|||Week 24 Distress Composite Score: MMRM model includes time (study week), treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and treatment\*time interaction, baseline OR-SDS distress scores, and baseline average pain intensity at the index bone metastasis cancer pain site as covariates.||0.47|-0.68|0.7143
72387616|NCT02609828|144283491|SUPERIORITY||Difference in LS mean|0.09|STANDARD_ERROR_OF_MEAN|0.18||0.6381|TWO_SIDED|95.0|-0.28|0.45|||Mixed Models Analysis|||Week 2 MDA Composite Score: MMRM model includes time (study week), treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and treatment\*time interaction, baseline OR-SDS MDA scores, and baseline average pain intensity at the index bone metastasis cancer pain site as covariates.||0.45|-0.28|0.6381
72387617|NCT02609828|144283491|SUPERIORITY||Difference in LS mean|0.06|STANDARD_ERROR_OF_MEAN|0.15||0.7181|TWO_SIDED|95.0|-0.25|0.37|||Mixed Models Analysis|||Week 4 MDA Composite Score: MMRM model includes time (study week), treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and treatment\*time interaction, baseline OR-SDS MDA scores, and baseline average pain intensity at the index bone metastasis cancer pain site as covariates.||0.37|-0.25|0.7181
72387618|NCT02609828|144283491|SUPERIORITY||Difference in least square (LS) mean|-0.04|STANDARD_ERROR_OF_MEAN|0.17||0.8378|TWO_SIDED|95.0|-0.38|0.31|||Mixed Models Analysis|||Week 8 MDA Composite Score: MMRM model includes time (study week), treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and treatment\*time interaction, baseline OR-SDS MDA scores, and baseline average pain intensity at the index bone metastasis cancer pain site as covariates.||0.31|-0.38|0.8378
72387619|NCT02609828|144283491|SUPERIORITY||Difference in LS mean|-0.06|STANDARD_ERROR_OF_MEAN|0.23||0.795|TWO_SIDED|95.0|-0.52|0.4|||Mixed Models Analysis|||Week 16 MDA Composite Score: MMRM model includes time (study week), treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and treatment\*time interaction, baseline OR-SDS MDA scores, and baseline average pain intensity at the index bone metastasis cancer pain site as covariates.||0.40|-0.52|0.7950
72441136|NCT00802464|144395557|OTHER||Fold increase|1.3|||||TWO_SIDED|95.0|1.09|1.56||||||Fold increase in frequency of gE-specific CD4+ T-cells secreting at least 2 different immunological activation markers among IFN-γ, IL-2, TNF-α and CD40L for GSK1437173A Formulation 1 over GSK1437173A Formulation 2 Group.||1.56|1.09|
72559233|NCT01634139|144648095|SUPERIORITY_OR_OTHER||Median Difference (Net)|-0.043|STANDARD_ERROR_OF_MEAN|0.047||0.3552|TWO_SIDED|95.0|-0.136|0.04|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 48||0.040|-0.136|0.3552
72559234|NCT01634139|144648096|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.039|STANDARD_ERROR_OF_MEAN|0.049||0.4359|TWO_SIDED|95.0|-0.135|0.058|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 24||0.058|-0.135|0.4359
72387620|NCT02609828|144283491|SUPERIORITY||Difference in LS mean|-0.11|STANDARD_ERROR_OF_MEAN|0.25||0.6719|TWO_SIDED|95.0|-0.62|0.4|||Mixed Models Analysis|||Week 24 MDA Composite Score: MMRM model includes time (study week), treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and treatment\*time interaction, baseline OR-SDS MDA scores, and baseline average pain intensity at the index bone metastasis cancer pain site as covariates.||0.40|-0.62|0.6719
72387621|NCT03285984|144283539|SUPERIORITY||Mean Difference (Net)|-0.21|||<|0.0001|TWO_SIDED|95.0|-0.27|-0.15||From ANCOVA model with factors for treatment group, period and subject (random effect), and subject-level baseline and period-level baseline|ANCOVA||Difference is first named treatment minus second-named treatment such that a negative difference favors the first named treatment|||-0.15|-0.27|<.0001
72387622|NCT00413244|144283541|SUPERIORITY_OR_OTHER|||||||0.03|||||||log mean|||"Statistician used all the time points post-baseline together (Overall). The result gives the estimates and 95% CI of the treatment effect from longitudinal analyses (generalized estimating equation method) which basically pools data from all visits post-baseline."||||0.03
72387623|NCT04545060|144283560|SUPERIORITY||adjusted relative risk ratio|0.21|||<|0.001|TWO_SIDED|95.0|0.09|0.5||two-sided, alpha=0.05|poisson regression model|||||0.50|0.09|<0.001
72387624|NCT04545060|144283578|SUPERIORITY||relative risk ratio|0.34|||<|0.001|TWO_SIDED|95.0|0.19|0.63||two-sided, alpha=0.05|poisson regression model|||||0.63|0.19|<0.001
72387625|NCT04545060|144283579|SUPERIORITY||Least squares mean difference|-1.07|||<|0.001|TWO_SIDED|95.0|-1.38|-0.76||two-sided, alpha=0.05|ANCOVA|||||-0.76|-1.38|<0.001
72387626|NCT04545060|144283581|SUPERIORITY||Least squares mean difference|-0.232||||0.007|TWO_SIDED|95.0|-0.399|-0.065||two-sided, alpha=0.05|Mixed model repeated measures|||||-0.065|-0.399|0.007
72387627|NCT04545060|144283585|SUPERIORITY||relative risk ratio|0.26||||0.002|TWO_SIDED|95.0|0.12|0.59||two-sided, alpha=0.05|poisson regression model|||||0.59|0.12|0.002
72387628|NCT02319837|144283598|OTHER|Two-sided P-value was based on a stratified log-rank test by screening PSA, PSA doubling time, and prior hormonal therapy. Hazard ratio was based on a Cox regression model stratified by factors defined above and was relative to placebo + leuprolide with \< 1 favoring enzalutamide + leuprolide.|Hazard Ratio (HR)|0.424|||<|0.0001|TWO_SIDED|95.0|0.296|0.607||Statistical significance can be declared if p-value \<0.05.|Log Rank|||||0.607|0.296|<0.0001
72387629|NCT02319837|144283599|OTHER|Two-sided P-value was based on a stratified log-rank test by screening PSA, PSA doubling time, and prior hormonal therapy. Hazard ratio was based on a Cox regression model stratified by factors defined above and was relative to placebo + leuprolide with \< 1 favoring enzalutamide monotherapy.|Hazard Ratio (HR)|0.631||||0.0049|TWO_SIDED|95.0|0.456|0.871||Statistical significance can be declared if p-value \<0.03.|Log Rank|||||0.871|0.456|0.0049
72387630|NCT02319837|144283600|OTHER|Two-sided P-value was based on a stratified log-rank test by screening PSA, PSA doubling time, and prior hormonal therapy. Hazard ratio was based on a Cox regression model stratified by factors defined above and was relative to placebo + leuprolide with \< 1 favoring enzalutamide + leuprolide.|Hazard Ratio (HR)|0.068|||<|0.0001|TWO_SIDED|95.0|0.033|0.141||Statistical significance can be declared if p-value \<0.02.|Log Rank|||||0.141|0.033|<0.0001
72387631|NCT02319837|144283600|OTHER|Two-sided P-value was based on a stratified log-rank test by screening PSA, PSA doubling time, and prior hormonal therapy. Hazard ratio was based on a Cox regression model stratified by factors defined above and was relative to placebo + leuprolide with \< 1 favoring enzalutamide monotherapy.|Hazard Ratio (HR)|0.331|||<|0.0001|TWO_SIDED|95.0|0.226|0.486||Statistical significance can be declared if p-value \<0.03.|Log Rank|||||0.486|0.226|<0.0001
72387632|NCT02319837|144283601|OTHER|Two-sided P-value was based on a stratified log-rank test by screening PSA, PSA doubling time, and prior hormonal therapy. Hazard ratio was based on a Cox regression model stratified by factors defined above and was relative to placebo + leuprolide with \< 1 favoring enzalutamide + leuprolide.|Hazard Ratio (HR)|0.358|||<|0.0001|TWO_SIDED|95.0|0.263|0.488||Statistical significance can be declared if p-value \<0.02.|Log Rank|||||0.488|0.263|<0.0001
72387633|NCT02319837|144283601|OTHER|Two-sided P-value was based on a stratified log-rank test by screening PSA, PSA doubling time, and prior hormonal therapy. Hazard ratio was based on a Cox regression model stratified by factors defined above and was relative to placebo + leuprolide with \< 1 favoring enzalutamide monotherapy.|Hazard Ratio (HR)|0.54|||<|0.0001|TWO_SIDED|95.0|0.411|0.709||Statistical significance can be declared if p-value \<0.03.|Log Rank|||||0.709|0.411|<0.0001
72387634|NCT02319837|144283603|OTHER|Two-sided P-value was based on a stratified log-rank test by screening PSA, PSA doubling time, and prior hormonal therapy. Hazard ratio was based on a Cox regression model stratified by factors defined above and was relative to placebo + leuprolide with \< 1 favoring enzalutamide + leuprolide.|Hazard Ratio (HR)|0.443||||0.0002|TWO_SIDED|95.0|0.284|0.69|||Log Rank|||||0.690|0.284|0.0002
72441137|NCT00802464|144395558|OTHER||Fold increase|4.72|||||TWO_SIDED|95.0|3.81|5.85||||||Fold increase in anti-gE antibody concentrations for GSK1437173A Formulation 1 Group over GSK1437173A Formulation 3 Group.||5.85|3.81|
72559235|NCT01634139|144648096|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.059|STANDARD_ERROR_OF_MEAN|0.049||0.2293|TWO_SIDED|95.0|-0.155|0.037|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 24||0.037|-0.155|0.2293
72387635|NCT02319837|144283603|OTHER|Two-sided P-value was based on a stratified log-rank test by screening PSA, PSA doubling time, and prior hormonal therapy. Hazard ratio was based on a Cox regression model stratified by factors defined above and was relative to placebo + leuprolide with \< 1 favoring enzalutamide monotherapy.|Hazard Ratio (HR)|0.614||||0.0171|TWO_SIDED|95.0|0.409|0.92|||Log Rank|||||0.920|0.409|0.0171
72559236|NCT01634139|144648096|SUPERIORITY_OR_OTHER||Median Difference (Net)|-0.01|STANDARD_ERROR_OF_MEAN|0.05||0.8372|TWO_SIDED|95.0|-0.108|0.088|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 48||0.088|-0.108|0.8372
72559237|NCT01634139|144648096|SUPERIORITY_OR_OTHER||Median Difference (Net)|-0.051|STANDARD_ERROR_OF_MEAN|0.049||0.3022|TWO_SIDED|95.0|-0.148|0.046|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 48||0.046|-0.148|0.3022
72559238|NCT01634139|144648097|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.031|STANDARD_ERROR_OF_MEAN|0.046||0.5004|TWO_SIDED|95.0|-0.122|0.06|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 24||0.060|-0.122|0.5004
72387636|NCT02319837|144283604|OTHER||difference of percentage of participants|25.9|||<|0.0001|TWO_SIDED|95.0|20.7|31.0||P-value was based on a Cochran-Mantel-Haenszel test stratified by screening PSA, PSA doubling time, and prior hormonal therapy.|Cochran-Mantel-Haenszel|||||31.0|20.7|<0.0001
72387637|NCT02319837|144283604|OTHER||difference of percentage of participants|18.8|||<|0.0001|TWO_SIDED|95.0|13.0|24.6||P-value was based on a Cochran-Mantel-Haenszel test stratified by screening PSA, PSA doubling time, and prior hormonal therapy.|Cochran-Mantel-Haenszel|||||24.6|13.0|<0.0001
72387638|NCT02319837|144283605|OTHER||difference of percentage of participants|7.5||||0.0439|TWO_SIDED|95.0|-0.2|15.2||P-value was based on a Cochran-Mantel-Haenszel test stratified by screening PSA, PSA doubling time, and prior hormonal therapy.|Cochran-Mantel-Haenszel|||||15.2|-0.2|0.0439
72387639|NCT02319837|144283605|OTHER||difference of percentage of participants|-12.9||||0.0004|TWO_SIDED|95.0|-19.8|-6.1||P-value was based on a Cochran-Mantel-Haenszel test stratified by screening PSA, PSA doubling time, and prior hormonal therapy.|Cochran-Mantel-Haenszel|||||-6.1|-19.8|0.0004
72387640|NCT02319837|144283606|OTHER||difference of percentage of participants|7.2||||0.0089|TWO_SIDED|95.0|1.7|12.8||P-value was based on a Cochran-Mantel-Haenszel test stratified by screening PSA, PSA doubling time, and prior hormonal therapy.|Cochran-Mantel-Haenszel|||||12.8|1.7|0.0089
72387641|NCT02319837|144283606|OTHER||difference of percentage of participants|-5.0||||0.0326|TWO_SIDED|95.0|-9.4|-0.6||P-value was based on a Cochran-Mantel-Haenszel test stratified by screening PSA, PSA doubling time, and prior hormonal therapy.|Cochran-Mantel-Haenszel|||||-0.6|-9.4|0.0326
72387642|NCT02319837|144283607|OTHER|Two-sided P-value was based on a stratified log-rank test by screening PSA, PSA doubling time, and prior hormonal therapy. Hazard ratio was based on a Cox regression model stratified by factors defined above and was relative to placebo + leuprolide with \< 1 favoring enzalutamide + leuprolide.|Hazard Ratio (HR)|0.693|||<|0.0001|TWO_SIDED|95.0|0.577|0.834|||Log Rank|||||0.834|0.577|<0.0001
72387643|NCT02319837|144283607|OTHER|Two-sided P-value was based on a stratified log-rank test by screening PSA, PSA doubling time, and prior hormonal therapy. Hazard ratio was based on a Cox regression model stratified by factors defined above and was relative to placebo + leuprolide with \< 1 favoring enzalutamide monotherapy.|Hazard Ratio (HR)|1.655|||<|0.0001|TWO_SIDED|95.0|1.381|1.984|||Log Rank|||||1.984|1.381|<0.0001
72387644|NCT02319837|144283608|OTHER|Two-sided P-value was based on a stratified log-rank test by screening PSA, PSA doubling time, and prior hormonal therapy. Hazard ratio was based on a Cox regression model stratified by factors defined above and was relative to placebo + leuprolide with \< 1 favoring enzalutamide + leuprolide.|Hazard Ratio (HR)|0.09|||<|0.0001|TWO_SIDED|95.0|0.051|0.157|||Log Rank|||||0.157|0.051|<0.0001
72387645|NCT02319837|144283609|OTHER|Two-sided P-value was based on a stratified log-rank test by screening PSA, PSA doubling time, and prior hormonal therapy. Hazard ratio was based on a Cox regression model stratified by factors defined above and was relative to placebo + leuprolide with \< 1 favoring enzalutamide + leuprolide.|Hazard Ratio (HR)|0.546|||<|0.0001|TWO_SIDED|95.0|0.427|0.699|||Log Rank|||||0.699|0.427|<0.0001
72387646|NCT02319837|144283609|OTHER|Two-sided P-value was based on a stratified log-rank test by screening PSA, PSA doubling time, and prior hormonal therapy. Hazard ratio was based on a Cox regression model stratified by factors defined above and was relative to placebo + leuprolide with \< 1 favoring enzalutamide monotherapy.|Hazard Ratio (HR)|0.619|||<|0.0001|TWO_SIDED|95.0|0.488|0.785|||Log Rank|||||0.785|0.488|<0.0001
72387647|NCT02319837|144283610|OTHER|Two-sided P-value was based on a stratified log-rank test by screening PSA, PSA doubling time, and prior hormonal therapy. Hazard ratio was based on a Cox regression model stratified by factors defined above and was relative to placebo + leuprolide with \< 1 favoring enzalutamide + leuprolide.|Hazard Ratio (HR)|0.261||||0.0001|TWO_SIDED|95.0|0.125|0.548|||Log Rank|||||0.548|0.125|0.0001
72441138|NCT00802464|144395558|OTHER||Fold increase|3.36|||||TWO_SIDED|95.0|2.72|4.17||||||Fold increase in anti-gE antibody concentrations for GSK1437173A Formulation 2 Group over GSK1437173A Formulation 3 Group.||4.17|2.72|
72441139|NCT00802464|144395558|OTHER||Fold increase|1.4|||||TWO_SIDED|95.0|1.17|1.68||||||Fold increase in anti-gE antibody concentrations for GSK1437173A Formulation 1 Group over GSK1437173A Formulation 2 Group.||1.68|1.17|
72441140|NCT00802464|144395559|OTHER||Fold increase|3.21|||||TWO_SIDED|36.0|2.64|3.9||||||Fold increase in anti-gE antibody concentrations for GSK1437173A Formulation 1 Group over GSK1437173A Formulation 3 Group.||3.9|2.64|
72441141|NCT00802464|144395559|OTHER||Fold increase|2.44|||||TWO_SIDED|95.0|2.02|2.97||||||Fold increase in anti-gE antibody concentrations for GSK1437173A Formulation 2 Group over GSK1437173A Formulation 3 Group.||2.97|2.02|
72441142|NCT00802464|144395559|OTHER||Fold increase|1.31|||||TWO_SIDED|95.0|1.12|1.54||||||Fold increase in anti-gE antibody concentrations for GSK1437173A Formulation 1 Group over GSK1437173A Formulation 2 Group.||1.54|1.12|
72441143|NCT00402246|144395576|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|17.4|||<|0.001||95.0||||The a priori threshold for significance was an alpha level of 0.05.|Wilcoxon (Mann-Whitney)|||The null hypothesis is that the time from a clinical event to a clinical decision for patients followed through the remote management system is greater than and equal to that of patients receiving only in-office care.||||<0.001
72496109|NCT00700180|144522017|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.07||||0.8127|TWO_SIDED|95.0|0.63|1.8||Multiple logistic regression model with treatment, biomarker level (dichotomized) and baseline prognostic factors as covariates.|Regression, Logistic|||bFGF (high versus low)||1.80|0.63|0.8127
72387648|NCT02319837|144283610|OTHER|Two-sided P-value was based on a stratified log-rank test by screening PSA, PSA doubling time, and prior hormonal therapy. Hazard ratio was based on a Cox regression model stratified by factors defined above and was relative to placebo + leuprolide with \< 1 favoring enzalutamide monotherapy.|Hazard Ratio (HR)|0.423||||0.0057|TWO_SIDED|95.0|0.226|0.794|||Log Rank|||||0.794|0.226|0.0057
72387649|NCT02319837|144283611|OTHER|Two-sided P-value was based on a stratified log-rank test by screening PSA, PSA doubling time, and prior hormonal therapy. Hazard ratio was based on a Cox regression model stratified by factors defined above and was relative to placebo + leuprolide with \< 1 favoring enzalutamide + leuprolide.|Hazard Ratio (HR)|1.078||||0.4321|TWO_SIDED|95.0|0.894|1.301|||Log Rank|||||1.301|0.894|0.4321
72387650|NCT02319837|144283611|OTHER|Two-sided P-value was based on a stratified log-rank test by screening PSA, PSA doubling time, and prior hormonal therapy. Hazard ratio was based on a Cox regression model stratified by factors defined above and was relative to placebo + leuprolide with \< 1 favoring enzalutamide monotherapy.|Hazard Ratio (HR)|1.09||||0.3702|TWO_SIDED|95.0|0.904|1.314|||Log Rank|||||1.314|0.904|0.3702
72387651|NCT02319837|144283612|OTHER|Two-sided P-value was based on a stratified log-rank test by screening PSA, PSA doubling time, and prior hormonal therapy. Hazard ratio was based on a Cox regression model stratified by factors defined above and was relative to placebo + leuprolide with \< 1 favoring enzalutamide + leuprolide.|Hazard Ratio (HR)|1.138||||0.1567|TWO_SIDED|95.0|0.954|1.357|||Log Rank|||||1.357|0.954|0.1567
72387652|NCT02319837|144283612|OTHER|Two-sided P-value was based on a stratified log-rank test by screening PSA, PSA doubling time, and prior hormonal therapy. Hazard ratio was based on a Cox regression model stratified by factors defined above and was relative to placebo + leuprolide with \< 1 favoring enzalutamide monotherapy.|Hazard Ratio (HR)|1.168||||0.0855|TWO_SIDED|95.0|0.981|1.391|||Log Rank|||||1.391|0.981|0.0855
72387653|NCT00494299|144283653|SUPERIORITY_OR_OTHER||Log Rank|0.2520462|||||||||||||The comparison between the 2 groups is done using the log rank test stratified by the response of TACE (Responder group A versus Responder group B), ECOG performance status (PS) (0 versus 1) and the number of prior TACE (1 versus 2).|||||
72387654|NCT00494299|144283653|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.8735||||||95.0|0.6972|1.0942|||||Hazard Ratio: Sorafenib/Placebo.|||1.0942|0.6972|
72387655|NCT02635776|144283715|SUPERIORITY||Risk Difference (RD)|63.2|||<|0.0001|TWO_SIDED|95.0|53.0|73.3|||Farrington-Manning test|||Treatment difference at 600 mg||73.3|53|<0.0001
72559239|NCT01634139|144648097|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.059|STANDARD_ERROR_OF_MEAN|0.046||0.1982|TWO_SIDED|95.0|-0.149|0.031|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 24||0.031|-0.149|0.1982
72387656|NCT02635776|144283716|SUPERIORITY||Risk Difference (RD)|47.8|||<|0.0001|TWO_SIDED|95.0|38.0|57.7|||Farrington-Manning test|||Treatment difference at 1000 mg||57.7|38|<0.0001
72387657|NCT02635776|144283717|SUPERIORITY||Risk Difference (RD)|68.5|||<|0.0001|TWO_SIDED|95.0|58.6|78.5|||Farrington-Manning test|||Treatment difference at 300 mg||78.5|58.6|<0.0001
72387658|NCT02635776|144283718|SUPERIORITY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test (using equally spaced scores), stratified by region (North America, Europe)||Treatment difference in maximum severity||||<0.0001
72387659|NCT00660673|144283733|OTHER||||||<|0.001|||||||One-sample t-test|||"Change from initial LCIG infusion to end of study in off time was assessed for significance using a 1-sample paired t test"||||<0.001
72387660|NCT00660673|144283733|OTHER|||||||0.433|||||||One-sample t-test|||"Change from Baseline to end of study in off time was assessed for significance using a 1-sample paired t-test."||||0.433
72387661|NCT00660673|144283734|OTHER||||||<|0.001|||||||One-sample t-test|||"Change from initial LCIG infusion to end of study in on time without troublesome dyskinesia was assessed for significance using a 1-sample paired t-test."||||<0.001
72387662|NCT00660673|144283734|OTHER|||||||0.15|||||||One-sample t-test|||"Change from Baseline to end of study in on time without troublesome dyskinesia was assessed for significance using a 1-sample paired t test"||||0.150
72387663|NCT00660673|144283735|OTHER|||||||0.725|||||||One-sample t-test|||"Change from initial LCIG infusion to end of study in on time with troublesome dyskinesia was assessed for significance using a 1-sample paired t test"||||0.725
72387664|NCT00660673|144283735|OTHER|||||||0.019|||||||One-sample t-test|||"Change from Baseline to end of study in on time with troublesome dyskinesia was assessed for significance using a 1-sample paired t test"||||0.019
72387665|NCT02197273|144283764|SUPERIORITY_OR_OTHER|||||||0.764|||||||Wilcoxon (Mann-Whitney)|||||||0.764
72387666|NCT02197273|144283765|SUPERIORITY_OR_OTHER|||||||0.206|||||||Wilcoxon (Mann-Whitney)|||||||0.206
72387667|NCT02197273|144283766|SUPERIORITY_OR_OTHER||Fisher exact|0.486||||0.656|TWO_SIDED||||||Fisher Exact|||||||0.656
72387668|NCT01972568|144283775|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.56||||0.1208|TWO_SIDED|95.0|0.89|2.72|||Logistic regression model|||||2.72|0.89|0.1208
72387669|NCT01972568|144283783|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.31||||0.0048|TWO_SIDED|95.0|1.44|7.61|||Logistic regression model|||||7.61|1.44|0.0048
72387670|NCT01972568|144283784|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.96||||0.0202|TWO_SIDED|95.0|1.11|3.46|||Logistic regression model|||||3.46|1.11|0.0202
72387671|NCT02572401|144283785|SUPERIORITY||Risk Ratio (RR)|0.84|||<|0.05|TWO_SIDED|95.0|0.59|1.21|||Poisson regression|Adjusted for baseline of the criterion and time of follow-up assessment (6 vs. 12 months).|The numerator is the treatment.|The primary analysis tested the efficacy of the HIV risk reduction intervention by comparing the HIV Risk Reduction Only and HIV Risk Reduction and Text Messaging Arms to the Text Messaging Only and No-Intervention No Text Message Control Arms. This is a test of the main effect of the HIV risk reduction intervention.||1.21|.59|<.05
72496110|NCT00700180|144522017|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.81||||0.0285|TWO_SIDED|95.0|1.06|3.08||Multiple logistic regression model with treatment, biomarker level (dichotomized) and baseline prognostic factors as covariates.|Regression, Logistic|||E-selectin (high versus low)||3.08|1.06|0.0285
72496111|NCT00700180|144522017|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.09||||0.7478|TWO_SIDED|95.0|0.64|1.85||Multiple logistic regression model with treatment, biomarker level (dichotomized) and baseline prognostic factors as covariates.|Regression, Logistic|||ICAM (high versus low)||1.85|0.64|0.7478
72496112|NCT00700180|144522017|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.16||||0.6761|TWO_SIDED|95.0|0.58|2.33||Multiple logistic regression model with treatment, biomarker level (dichotomized) and baseline prognostic factors as covariates.|Regression, Logistic|||PlGF (high versus low)||2.33|0.58|0.6761
72496113|NCT00700180|144522017|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.22||||0.4601|TWO_SIDED|95.0|0.72|2.09||Multiple logistic regression model with treatment, biomarker level (dichotomized) and baseline prognostic factors as covariates.|Regression, Logistic|||VEGF A (high versus low)||2.09|0.72|0.4601
72496114|NCT00700180|144522017|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.77||||0.3193|TWO_SIDED|95.0|0.46|1.29||Multiple logistic regression model with treatment, biomarker level (dichotomized) and baseline prognostic factors as covariates.|Regression, Logistic|||VEGFR-1 (high versus low)||1.29|0.46|0.3193
72496115|NCT00700180|144522017|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.44||||0.1758|TWO_SIDED|95.0|0.85|2.45||Multiple logistic regression model with treatment, biomarker level (dichotomized) and baseline prognostic factors as covariates.|Regression, Logistic|||VEGFR-2 (high versus low)||2.45|0.85|0.1758
72559240|NCT01634139|144648097|SUPERIORITY_OR_OTHER||Median Difference (Net)|-0.012|STANDARD_ERROR_OF_MEAN|0.047||0.8019|TWO_SIDED|95.0|-0.103|0.08|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 48||0.080|-0.103|0.8019
72559241|NCT01634139|144648097|SUPERIORITY_OR_OTHER||Median Difference (Net)|-0.032|STANDARD_ERROR_OF_MEAN|0.046||0.4872|TWO_SIDED|95.0|-0.123|0.059|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 48||0.059|-0.123|0.4872
72559242|NCT01634139|144648098|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.043|STANDARD_ERROR_OF_MEAN|0.046||0.3498|TWO_SIDED|95.0|-0.135|0.048|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 24||0.048|-0.135|0.3498
72559243|NCT01634139|144648098|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.106|STANDARD_ERROR_OF_MEAN|0.046||0.0222|TWO_SIDED|95.0|-0.196|-0.015|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 24||-0.015|-0.196|0.0222
72559244|NCT01634139|144648098|SUPERIORITY_OR_OTHER||Median Difference (Net)|-0.012|STANDARD_ERROR_OF_MEAN|0.047||0.799|TWO_SIDED|95.0|-0.104|0.08|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 48||0.080|-0.104|0.7990
72619021|NCT00564070|144768455|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.0|STANDARD_ERROR_OF_MEAN|2.1||0.16|TWO_SIDED|95.0|-1.2|7.2|||Mixed Models Analysis|||We hypothesized that the lower depression scores would remain in the CBT arm compared to ETAU over follow up.||7.2|-1.2|.16
72619022|NCT00564070|144768456|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.48|STANDARD_ERROR_OF_MEAN|0.29||0.1|TWO_SIDED|95.0|-0.1|1.1|||Mixed Models Analysis|||We hypothesized that depression scores would remain lower in the CBT-AD arm compared to the ETAU arm||1.1|-.1|.10
72559245|NCT01634139|144648098|SUPERIORITY_OR_OTHER||Median Difference (Net)|-0.035|STANDARD_ERROR_OF_MEAN|0.047||0.4586|TWO_SIDED|95.0|-0.126|0.057|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 48||0.057|-0.126|0.4586
72619023|NCT00564070|144768457|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.63|STANDARD_ERROR_OF_MEAN|0.29||0.03|TWO_SIDED|95.0|0.6|1.2|||Mixed Models Analysis|||We hypothesized that glucose control (HbA1C) would remain superior in the CBT-AD arm compared to the ETAU arm over follow up.||1.2|.6|.03
72559246|NCT01634139|144648099|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.045|STANDARD_ERROR_OF_MEAN|0.056||0.4221|TWO_SIDED|95.0|-0.156|0.065|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 24||0.065|-0.156|0.4221
72619024|NCT03142334|144768472|OTHER|HR and the associated 95% CIs were calculated based on Cox Regression model and p-value was calculated based on log-rank test, in accordance with the statistical analysis plan.|Hazard Ratio (HR)|0.68||||0.001|TWO_SIDED|95.0|0.53|0.87|||Log Rank|One-sided p-value was based on log-rank test stratified by metastasis status, ECOG PS, US participant within M0 group by investigator.|Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by metastasis status, ECOG PS, and US participant within M0 group by investigator was used to calculate HR and 95% CIs.|||0.87|0.53|0.0010
72619025|NCT03071965|144768484|SUPERIORITY||Median Difference (Final Values)|-0.053|STANDARD_ERROR_OF_MEAN|0.0881||0.5455|TWO_SIDED|95.0|-0.226|0.12|||Mixed Models Analysis|||||0.120|-0.226|0.5455
72559247|NCT01634139|144648099|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.093|STANDARD_ERROR_OF_MEAN|0.056||0.0959|TWO_SIDED|95.0|-0.204|0.017|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 24||0.017|-0.204|0.0959
72619026|NCT03892915|144768541|SUPERIORITY||Odds Ratio (OR)|1.19|||||TWO_SIDED|95.0|0.73|1.93||||||||1.93|0.73|
72619027|NCT03892915|144768542|SUPERIORITY||beta coefficient|5.33|STANDARD_ERROR_OF_MEAN|5.39|||TWO_SIDED|||||||||||||
72619028|NCT03892915|144768544|SUPERIORITY||Odds Ratio (OR)|1.85|||||TWO_SIDED|95.0|0.53|6.5||||||||6.50|0.53|
72496116|NCT00700180|144522019|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.01||||0.9454|TWO_SIDED|95.0|0.78|1.31|||Log Rank|||||1.31|0.78|0.9454
72496117|NCT00700180|144522020|SUPERIORITY_OR_OTHER||Difference in Responses Rates|9.34||||0.1737|TWO_SIDED|95.0|-2.4|21.0|||Cochran-Mantel-Haenszel||Approximate 95% Confidence Interval (CI) for difference of two rates using Hauck-Anderson method.|||21.0|-2.4|0.1737
72496118|NCT00700180|144522021|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.75||||0.6148|TWO_SIDED|95.0|-8.2|11.7|||Cochran-Mantel-Haenszel||Approximate 95% CI for difference of two rates using Hauck-Anderson method|||11.7|-8.2|0.6148
72496119|NCT00700180|144522023|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.07||||0.7587|TWO_SIDED|95.0|0.68|1.69|||Log Rank|||||1.69|0.68|0.7587
72496120|NCT00700180|144522025|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.16||||0.312|TWO_SIDED|95.0|0.87|1.53|||Log Rank|||||1.53|0.87|0.3120
72559248|NCT01634139|144648099|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.003|STANDARD_ERROR_OF_MEAN|0.057||0.9627|TWO_SIDED|95.0|-0.109|0.114|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 48||0.114|-0.109|0.9627
72559249|NCT01634139|144648099|SUPERIORITY_OR_OTHER||Median Difference (Net)|-0.054|STANDARD_ERROR_OF_MEAN|0.057||0.3457|TWO_SIDED|95.0|-0.165|0.058|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 48||0.058|-0.165|0.3457
72496121|NCT03216382|144522056|SUPERIORITY|||||||0.93||||||The apriori threshold for significance was a = 0.05. The p value reflects the test of an interaction between condition and time.|ANOVA|||||||.93
72496122|NCT03216382|144522057|SUPERIORITY|||||||0.74||||||this value represents the interaction between condition and the intervention time period The apriori threshold for significance was a = 0.05.|Mixed Models Analysis|||HLM piecewise analysis was used to examine linear change from day 1-7 (visit 1 to visit 2) and change from day 7-14 (visit 2 to visit 3) on uncontrollability of worry||||.74
72496123|NCT03216382|144522057|SUPERIORITY|||||||0.44||||||this value represents the interaction between condition and the intervention time period (squared) The apriori threshold for significance was a = 0.05.|Mixed Models Analysis|||HLM piecewise analysis was used to examine quadratic change from day 1-7 (visit 1 to visit 2) and change from day 7-14 (visit 2 to visit 3) on uncontrollability of worry||||.44
72496124|NCT03216382|144522058|SUPERIORITY|||||||0.17||||||the apriori threshold for significance was a = 0.05 The p value reflects the test of an interaction between condition and time.|ANOVA|||||||.17
72496125|NCT03216382|144522059|SUPERIORITY|||||||0.5||||||The apriori threshold for significance was a = 0.05 The p value reflects the test of an interaction between condition and time .|Mixed Models Analysis|||HLM piecewise analysis was used to examine linear change from day 1-7 (visit 1 to visit 2) and change from day 7-14 (visit 2 to visit 3) on self-focused attention||||.50
72496126|NCT03216382|144522059|SUPERIORITY|||||||0.02||||||The apriori threshold for significance was a= 0.05. The p value reflects the test of an interaction between condition and intervention period (days 7-14, squared).|Mixed Models Analysis|||HLM piecewise analysis was used to examine quadratic change from day 1-7 (visit 1 to visit 2) and change from day 7-14 (visit 2 to visit 3) on self-focused attention||||.02
72496127|NCT03216382|144522060|SUPERIORITY|||||||0.46||||||the apriori threshold for significance was a = 0.05 The p value reflects the test of an interaction between condition and time.|ANOVA|||||||.46
72387672|NCT02572401|144283785|SUPERIORITY||Risk Ratio (RR)|0.99|||<|0.05|TWO_SIDED|95.0|0.69|1.42|||Poisson regression|Adjusted for baseline of the criterion and time of follow-up assessment (6 vs. 12 months).|The numerator is the treatment.|This analysis tested the efficacy of the text messaging intervention by comparing the HIV Risk Reduction and Text Messaging and Text Messaging Only Arms to the HIV Risk Reduction Only and No-Intervention No Text Message Control Arms. This is a test of the text messaging main effect.||1.42|0.69|<.05
72387673|NCT02572401|144283785|SUPERIORITY||Risk Ratio (RR)|0.72|||<|0.05|TWO_SIDED|95.0|0.35|1.49|||Poisson regression|Adjusted for baseline of the criterion, time of follow-up assessment (6 vs. 12 months), and the HIV x Time and Text Messaging x Time interactions.|The numerator is the treatment.|The analysis tested whether text messaging enhanced the effects of the HIV risk reduction intervention by comparing the HIV Risk Reduction and Text Messaging and No-Intervention No Text Message Arms to the Text Messaging Only and HIV Risk Reduction Only Arms. This is a test of the interaction between the two types of interventions.||1.49|.35|<.05
72387674|NCT02572401|144283786|SUPERIORITY||Risk Ratio (RR)|1.04|||<|0.05|TWO_SIDED|95.0|0.92|1.18|||Poisson regression|Adjusted for baseline of the criterion and time of follow-up assessment (6 vs. 12 months).|The numerator is the treatment.|The primary analysis tested the efficacy of the HIV risk reduction intervention by comparing the HIV Risk Reduction Only and HIV Risk Reduction and Text Messaging Arms to the Text Messaging Only and No-Intervention No Text Message Control Arms. This is a test of the main effect of the HIV risk reduction intervention.||1.18|0.92|<.05
72387675|NCT02572401|144283786|SUPERIORITY||Risk Ratio (RR)|1.02|||<|0.05|TWO_SIDED|95.0|0.9|1.16|||Poisson regression|Adjusted for baseline of the criterion.|The numerator is the treatment.|This analysis tested the efficacy of the text messaging intervention by comparing the HIV Risk Reduction and Text Messaging and Text Messaging Only Arms to the HIV Risk Reduction Only and No-Intervention No Text Message Control Arms. This is a test of the text messaging main effect.||1.16|0.90|<.05
72387676|NCT02572401|144283786|SUPERIORITY||Risk Ratio (RR)|1.1|||<|0.05|TWO_SIDED|95.0|0.86|1.42|||Poisson regression|Adjusted for baseline of the criterion, time of follow-up assessment (6 vs. 12 months), and the HIV x Time and Text Messaging x Time interactions.|The numerator is the treatment.|The analysis tested whether text messaging enhanced the effects of the HIV risk reduction intervention by comparing the HIV Risk Reduction and Text Messaging and No-Intervention No Text Message Arms to the Text Messaging Only and HIV Risk Reduction Only Arms. This is a test of the interaction between the two types of interventions.||1.42|0.86|<.05
72387677|NCT02572401|144283787|SUPERIORITY||Risk Ratio (RR)|1.05|||<|0.05|TWO_SIDED|95.0|0.89|1.24|||Poisson regression|Adjusted for baseline of the criterion.|The numerator is the treatment.|The primary analysis tested the efficacy of the HIV risk reduction intervention by comparing the HIV Risk Reduction Only and HIV Risk Reduction and Text Messaging Arms to the Text Messaging Only and No-Intervention No Text Message Control Arms. This is a test of the main effect of the HIV risk reduction intervention.||1.24|0.89|<.05
72387678|NCT02572401|144283787|SUPERIORITY||Risk Ratio (RR)|1.1|||<|0.05|TWO_SIDED|95.0|0.94|1.3|||Poisson regression|Adjusted for baseline of the criterion and time of follow-up assessment (6 vs. 12 months).||This analysis tested the efficacy of the text messaging intervention by comparing the HIV Risk Reduction and Text Messaging and Text Messaging Only Arms to the HIV Risk Reduction Only and No-Intervention No Text Message Control Arms. This is a test of the text messaging main effect.|The numerator is the treatment.|1.30|0.94|<.05
72496128|NCT03216382|144522061|SUPERIORITY|||||||0.53||||||the apriori threshold for significance was a = 0.05 The p value reflects the test of an interaction between condition and time.|ANOVA|||||||.53
72496129|NCT03216382|144522062|SUPERIORITY|||||||0.07||||||the apriori threshold for significance was a = 0.05. The p value reflects the test of an interaction between condition and time.|ANOVA|||||||.07
72496130|NCT03216382|144522063|SUPERIORITY|||||||0.58||||||the apriori threshold for significance was 0.05 The p value reflects the test of an interaction between condition and time.|ANOVA|||||||.58
72496131|NCT03216382|144522064|SUPERIORITY|||||||0.86||||||the apriori threshold for significance was a = 0.05 The p value reflects the test of an interaction between condition and time.|ANOVA|||||||.86
72496132|NCT03216382|144522065|SUPERIORITY|||||||0.39||||||the apriori threshold for significance was a = 0.05 The p value reflects the test of an interaction between condition and time.|ANOVA|||||||.39
72619029|NCT03892915|144768545|SUPERIORITY||Odds Ratio (OR)|2.73|||||TWO_SIDED|95.0|0.45|16.64||||||||16.64|0.45|
72619030|NCT03892915|144768546|SUPERIORITY||Odds Ratio (OR)|0.2|||||TWO_SIDED|95.0|0.05|0.83||||||||0.83|0.05|
72387679|NCT02572401|144283787|SUPERIORITY||Risk Ratio (RR)|1.05|||<|0.05|TWO_SIDED|95.0|0.76|1.47|||Poisson regression|Adjusted for baseline of the criterion, time of follow-up assessment (6 vs. 12 months), and the HIV x Time and Text Messaging x Time interactions.|The numerator is the treatment.|The analysis tested whether text messaging enhanced the effects of the HIV risk reduction intervention by comparing the HIV Risk Reduction and Text Messaging and No-Intervention No Text Message Arms to the Text Messaging Only and HIV Risk Reduction Only Arms. This is a test of the interaction between the two types of interventions.||1.47|0.76|<.05
72387680|NCT02572401|144283788|SUPERIORITY||Risk Ratio (RR)|1.04|||<|0.05|TWO_SIDED|95.0|0.73|1.48|||Poisson regression|Adjusted for baseline of the criterion and time of follow-up assessment (6 vs. 12 months).|The numerator is the treatment.|The primary analysis tested the efficacy of the HIV risk reduction intervention by comparing the HIV Risk Reduction Only and HIV Risk Reduction and Text Messaging Arms to the Text Messaging Only and No-Intervention No Text Message Control Arms. This is a test of the main effect of the HIV risk reduction intervention.||1.48|0.73|<.05
72387681|NCT02572401|144283788|SUPERIORITY||Risk Ratio (RR)|1.01|||<|0.05|TWO_SIDED|95.0|0.71|1.45|||Poisson regression|Adjusted for baseline of the criterion and time of follow-up assessment (6 vs. 12 months).|The numerator is the treatment.|This analysis tested the efficacy of the text messaging intervention by comparing the HIV Risk Reduction and Text Messaging and Text Messaging Only Arms to the HIV Risk Reduction Only and No-Intervention No Text Message Control Arms. This is a test of the text messaging main effect.||1.45|0.71|<.05
72387682|NCT02572401|144283788|SUPERIORITY||Risk Ratio (RR)|1.02|||<|0.05|TWO_SIDED|95.0|0.5|2.08|||Poisson regression|Adjusted for baseline of the criterion, time of follow-up assessment (6 vs. 12 months), and the HIV x Time and Text Messaging x Time interactions.|The numerator is the treatment.|The analysis tested whether text messaging enhanced the effects of the HIV risk reduction intervention by comparing the HIV Risk Reduction and Text Messaging and No-Intervention No Text Message Arms to the Text Messaging Only and HIV Risk Reduction Only Arms. This is a test of the interaction between the two types of interventions.||2.08|.50|<.05
72387683|NCT02572401|144283789|SUPERIORITY||Mean Difference (Final Values)|0.001|||<|0.05|TWO_SIDED|95.0|-0.078|0.08|||Regression, Linear|Adjusted for baseline of the criterion and time of follow-up assessment (6 vs. 12 months).||The primary analysis tested the efficacy of the HIV risk reduction intervention by comparing the HIV Risk Reduction Only and HIV Risk Reduction and Text Messaging Arms to the Text Messaging Only and No-Intervention No Text Message Control Arms. This is a test of the main effect of the HIV risk reduction intervention.||0.080|-0.078|<.05
72387684|NCT02572401|144283789|SUPERIORITY||Mean Difference (Final Values)|-0.003|||<|0.05|TWO_SIDED|95.0|-0.082|0.076|||Regression, Linear|Adjusted for baseline of the criterion and time of follow-up assessment (6 vs. 12 months).||This analysis tested the efficacy of the text messaging intervention by comparing the HIV Risk Reduction and Text Messaging and Text Messaging Only Arms to the HIV Risk Reduction Only and No-Intervention No Text Message Control Arms. This is a test of the text messaging main effect.||0.076|-0.082|<.05
72387685|NCT02572401|144283789|SUPERIORITY||Mean Difference (Final Values)|-0.009|||<|0.05|TWO_SIDED|95.0|-0.167|0.149|||Regression, Linear|Adjusted for baseline of the criterion, time of follow-up assessment (6 vs. 12 months), and the HIV x Time and Text Messaging x Time interactions.||The analysis tested whether text messaging enhanced the effects of the HIV risk reduction intervention by comparing the HIV Risk Reduction and Text Messaging and No-Intervention No Text Message Arms to the Text Messaging Only and HIV Risk Reduction Only Arms. This is a test of the interaction between the two types of interventions.||0.149|-0.167|<.05
72387686|NCT00306189|144283790|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.0|||<|0.0001||95.0|5.76|8.24|||t-test, 2 sided|||||8.24|5.76|<0.0001
72496133|NCT00927368|144522119|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority analysis used the 0.5-point noninferiority delta in a 1-tailed test of the treatment effect regression parameter (i.e., testing the null hypothesis that mean stimulating needle minus mean stimulating catheter is greater than 0.5 points).|Mean Difference (Final Values)|-0.16|||<|0.001|TWO_SIDED|95.0|-0.61|0.29||Significance criterion of 0.00694 after adjusting for group sequential design and applying Holm Bonferroni procedure to account for multiple comparisons.|t-test, 2 sided|||The primary analysis for pain was a linear regression model comparing stimulating needle to stimulating catheter on the mean time-weighted average pain score for a patient in the first 48 hours.||0.29|-0.61|< 0.001
72504753|NCT03114969|144540503|SUPERIORITY||Odds Ratio (OR)|3.941|||<|0.001|TWO_SIDED|95.0|1.863|8.337||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta+\[Relvar Ellipta+LAMA\] as comparator.|||8.337|1.863|<0.001
72559250|NCT01634139|144648100|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.041|STANDARD_ERROR_OF_MEAN|0.043||0.3375|TWO_SIDED|95.0|-0.043|0.125|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 24||0.125|-0.043|0.3375
72387687|NCT00306189|144283790|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.25|||<|0.0001||95.0|4.1|6.4|||t-test, 2 sided|||||6.4|4.1|<0.0001
72387688|NCT00306189|144283790|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.27|||<|0.0001||95.0|5.06|7.49|||t-test, 2 sided|||||7.49|5.06|<0.0001
72387689|NCT00945893|144283791|NON_INFERIORITY_OR_EQUIVALENCE|The currently proposed study provided at least 99.9% power to rule out a rate increase of 10 percentage points assuming the true difference between the treatment groups is zero and the true fever rate is ≤ 3%. Power is also high if the true difference is slightly greater than zero and the true fever rate is ≤ 3%.|Rate difference|0.0|||||TWO_SIDED|95.0|-6.0|1.9|||Score|||The upper limit of the two-sided 95% CI was evaluated against the prespecified equivalence criterion of 10% which corresponded to the following hypotheses: H0 (null): Rate Difference ≥ 10%, HA (alternative): Rate Difference \< 10%||1.9|-6.0|
72387690|NCT00945893|144283792|SUPERIORITY_OR_OTHER||rate difference|2.5|||||TWO_SIDED|95.0|-8.8|7.7|||score|||The number of participants who experienced a post-dose seroresponse was compared based on the upper limit of the limit of the two-sided 95% exact CI for the rate difference (Vaccine minus Placebo).||7.7|-8.8|
72504754|NCT03114969|144540503|SUPERIORITY||Odds Ratio (OR)|2.391||||0.03|TWO_SIDED|95.0|1.088|5.256||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta+\[Relvar Ellipta+LAMA\] as comparator.|||5.256|1.088|0.030
72441144|NCT00402246|144395577|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.06||||0.524|ONE_SIDED|95.0||1.21||Model was fit with device group (CRT-D vs. DR-ICD) as a stratifying variable.|Andersen-Gill model|An Andersen-Gill model was utilized to account for multiple hospitalization events per subject.||An Andersen-Gill proportional hazards regression model was fit to test the hypothesis that the CV hospitalization hazard rates for patients in the remote arm is equal to that of similar patients in the in-office arm.||1.21||0.524
72441145|NCT00402246|144395577|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.14||||0.325|ONE_SIDED|95.0||1.43||Model was fit with device group (CRT-D vs. DR-ICD) as a stratifying variable.|Andersen-Gill model|An Andersen-Gill model was utilized to account for multiple ED visits per subject.||An Andersen-Gill proportional hazards regression model was fit to test the hypothesis that the ED hazard rates for patients in the remote arm is equal to that of similar patients in the in-office arm.||1.43||0.325
72441146|NCT00402246|144395577|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.14||||0.099|ONE_SIDED|95.0||1.31||Model was fit with device group (CRT-D vs. DR-ICD) as a stratifying variable.|Andersen-Gill model|An Andersen-Gill model was utilized to account for multiple unscheduled clinic visits per subject.||An Andersen-Gill proportional hazards regression model was fit to test the hypothesis that the hazard rates of the CV unscheduled clinic or urgent care visits for patients in the remote arm is equal to that of similar patients in the in-office arm.||1.31||0.099
72441147|NCT00402246|144395578|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.45||||0.29|ONE_SIDED|95.0||2.56||Model was fit with device group (CRT-D vs. DR-ICD) as a stratifying variable.|Andersen-Gill model|||An Andersen-Gill proportional hazards regression model was fit to test the hypothesis that the hazard rate of transesophageal echocardiography (TEE) taken for patients in the remote arm is equal to that of similar patients in the in-office arm.||2.56||0.29
72441148|NCT00402246|144395581|SUPERIORITY_OR_OTHER||probability|0.23||||||95.0|||||Regression, Logistic|A GEE model was utilized to account for multiple events within same patient in estimating the probability of an AT/AF alert event being symptomatic.||||||
72441149|NCT00402246|144395583|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1|STANDARD_DEVIATION|4.3||0.779|TWO_SIDED|95.0|-0.8|1.0||The a priori threshold for significance was an alpha level of 0.05.|t-test, 2 sided|||The null hypothesis is that the time from event onset to clinical decision for symptom-driven device interrogations for patients followed through the remote management system is greater than and equal to that of patients receiving only in-office care.||1.0|-0.8|0.779
72441150|NCT00402246|144395584|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.0|STANDARD_DEVIATION|19.1|<|0.001|TWO_SIDED|95.0|-13.1|-6.9||The a priori threshold for significance was an alpha level of 0.05.|t-test, 2 sided|||The null hypothesis is the time from event onset to clinical decision for both device events and symptom-driven device interrogations for patients followed through the remote management system is greater than and equal to that of patients receiving only in-office care.||-6.9|-13.1|<0.001
72559251|NCT01634139|144648100|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.037|STANDARD_ERROR_OF_MEAN|0.043||0.388|TWO_SIDED|95.0|-0.047|0.121|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 24||0.121|-0.047|0.3880
72441151|NCT00402246|144395585|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.82||||0.002|TWO_SIDED|95.0|0.7|0.9||The a priori threshold for statistical significance was 0.05. The threshold was met, and the null hypothesis was rejected.|negative binomial model|||The null hypothesis was that the mean LOS per hospitalization visit for patients in the remote arm was equal to that for similar patients in the in-office arm.||0.9|0.7|0.002
72441152|NCT00402246|144395586|SUPERIORITY_OR_OTHER||compliance rate|0.761|||||ONE_SIDED|95.0|0.737||||Binomial Exact Test|||3-month compliance rate|||0.737|
72441153|NCT00402246|144395586|SUPERIORITY_OR_OTHER||compliance rate|0.815|||||ONE_SIDED|95.0|0.793||||Binomial Exact Test|||6-month compliance rate|||0.793|
72441154|NCT00402246|144395586|SUPERIORITY_OR_OTHER||compliance rate|0.815|||||ONE_SIDED|95.0|0.792||||Binomial Exact Test|||9-month compliance rate|||0.792|
72559252|NCT01634139|144648100|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.019|STANDARD_ERROR_OF_MEAN|0.043||0.6541|TWO_SIDED|95.0|-0.066|0.104|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 48||0.104|-0.066|0.6541
72441155|NCT00402246|144395586|SUPERIORITY_OR_OTHER||compliance rate|0.814|||||ONE_SIDED|95.0|0.79||||Binomial Exact Test|||12-month compliance rate|||0.79|
72441156|NCT00402246|144395588|SUPERIORITY_OR_OTHER|||||||0.217||95.0||||The a prior threshold for statistical significance was 0.05.|Mixed Models Analysis|Model was fit with randomization arm, device group (CRT-D vs. DR-ICD), and follow-up visit as fixed effects, and subject as a random effect.||A mixed model was fit to test whether patients followed through the remote management system will experience less anxiety than patients followed through in-office care.||||0.217
72441157|NCT00402246|144395589|SUPERIORITY_OR_OTHER|||||||0.154||95.0||||The a priori threshold for statistical significance for was 0.05.|Mixed Models Analysis|Model was fit with randomization arm, device group (CRT-D vs. DR-ICD), and follow-up visit as fixed effects, and subject as a random effect.||A mixed model was fit to test whether patients followed through the remote management system will experience less anxiety than patients followed through in-office care.||||0.154
72441158|NCT04425863|144395596|OTHER|||||||0.0246|||||||Chi-squared|||A chi-squared test is used to find out whether there is a statistically significant decrease in mortality rate when the IDEA treatment protocol is used in hospitalized patients in comparison with other treatments in the same hospital in the same period of time (3 out of 12 inpatients died)||||0.0246
72441159|NCT04425863|144395596|OTHER|||||||0.0475|||||||Chi-squared|||Overall mortality rate of patients treated according to IDEA protocol is compared by a chi-squared test against overall mortality rate in Argentina (the same region where the hospital is located). Data used for overall mortality in Argentina correspond to June 30th according to the website of the Ministry of Health of Argentina||||0.0475
72441160|NCT04425863|144395596|OTHER|||||||0.0025|||||||Chi-squared|||A chi-square test was applied to compare the mortality rate of patients treated with IDEA protocol as compared with data published (26.84 %) in Bertsimas D, Lukin G, Mingardi L, Nohadani O, Orfanoudaki A, Stellato B et al. (2020), COVID-19 Mortality Risk Assessment: An International Multi-Center Study doi: 10.1101/2020.07.07.20148304||||0.0025
72559253|NCT01634139|144648100|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.028|STANDARD_ERROR_OF_MEAN|0.043||0.5089|TWO_SIDED|95.0|-0.056|0.133|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 48||0.133|-0.056|0.5089
72441161|NCT02597920|144395599|OTHER||||||<|0.0001|||||||Paired t-test|||Within group comparison of Baseline CDS with that of Visit 2.||||<0.0001
72441162|NCT02597920|144395599|OTHER||||||<|0.0001|||||||Paired t-test|||Within group comparison of Baseline CDS with that of Visit 3.||||<0.0001
72441163|NCT02597920|144395599|OTHER||||||<|0.0001|||||||Paired t-test|||Within group comparison of Baseline SDS with that of Visit 2.||||<0.0001
72441164|NCT02597920|144395599|OTHER||||||<|0.0001|||||||Paired t-test|||Within group comparison of Baseline SDS with that of Visit 3.||||<0.0001
72441165|NCT02597920|144395600|OTHER|||||||0.0005|||||||Propensity score matching method|||Between group comparison of Visit 2 CDS||||0.0005
72441166|NCT02597920|144395600|OTHER|||||||0.0002|||||||Propensity score matching method|||Between group comparison of Visit 3 CDS||||0.0002
72441167|NCT02597920|144395600|OTHER|||||||0.0002|||||||Propensity score matching method|||Between group comparison of Visit 2 SDS||||0.0002
72496134|NCT00927368|144522119|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority analysis used the 0.5-point noninferiority delta in a 1-tailed test of the treatment effect regression parameter (i.e., testing the null hypothesis that mean stimulating catheter minus mean stimulating needle is greater than 0.5 points).|Mean Difference (Final Values)|0.16||||0.03|TWO_SIDED|95.0|-0.29|0.61||Significance criterion of 0.01735 after adjusting for group sequential design and applying Holm Bonferroni procedure to account for multiple comparisons.|t-test, 2 sided|||The primary analysis for pain was a linear regression model comparing stimulating catheter to stimulating needle on the mean time-weighted average pain score for a patient in the first 48 hours.||0.61|-0.29|0.03
72496135|NCT00927368|144522119|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority analysis used the 0.5-point noninferiority delta in a 1-tailed test of the treatment effect regression parameter (i.e., testing the null hypothesis that mean catheter minus mean ultrasound alone is greater than 0.5 points).|Mean Difference (Final Values)|-0.12|||<|0.001|TWO_SIDED|95.0|-0.57|0.33||Significance criterion of 0.01041 after adjusting for group sequential design and applying Holm Bonferroni procedure to account for multiple comparisons.|t-test, 2 sided|||The primary analysis for pain was a linear regression model comparing stimulating catheter to ultrasound alone on the mean time-weighted average pain score for a patient in the first 48 hours.||0.33|-0.57|< 0.001
72496136|NCT00927368|144522119|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority analysis used the 0.5-point noninferiority delta in a 1-tailed test of the treatment effect regression parameter (i.e., testing the null hypothesis that mean ultrasound alone minus mean catheter is greater than 0.5 points).|Mean Difference (Final Values)|0.12||||0.02|TWO_SIDED|95.0|-0.33|0.57||Significance criterion of 0.01388 after adjusting for group sequential design and applying Holm Bonferroni procedure to account for multiple comparisons.|t-test, 2 sided|||The primary analysis for pain was a linear regression model comparing ultrasound alone to stimulating catheter on the mean time-weighted average pain score for a patient in the first 48 hours.||0.57|-0.33|0.02
72559254|NCT01694563|144648115|SUPERIORITY|||||||0.05|||||||Fisher Exact|||The primary effectiveness hypothesis for this study was to demonstrate a superiority success rate at 36-months follow-up in patients treated with the AtriCure Synergy Ablation System compared to a pre-established performance goal.||||0.05
72441168|NCT02597920|144395600|OTHER|||||||0.0004|||||||Propensity score matching method|||Between group comparison of Visit 3 SDS||||0.0004
72559255|NCT01694563|144648116|SUPERIORITY||Clopper-Pearson|90.0|||||TWO_SIDED|90.0|||||||90% confidence interval calculated using the Clopper-Pearson method.|Secondary success was defined as freedom from AF regardless of antiarrhythmic drug usage at 12 months post-operatively.||||
72441169|NCT02597920|144395605|OTHER||||||<|0.0001|||||||Paired t-test|||Within group comparison of Visit 2 CDS with that of Visit 3.||||<0.0001
72441170|NCT02597920|144395605|OTHER||||||<|0.0001|||||||Paired t-test|||Within group comparison of Visit 2 SDS with that of Visit 3.||||<0.0001
72441171|NCT02549170|144395614|SUPERIORITY||Newcombe confidence interval|-21.8|||=|0.0045|TWO_SIDED|95.0|-34.45|-7.94|||Chi-squared|||||-7.94|-34.45|=0.0045
72441172|NCT02549170|144395616|SUPERIORITY||Newcombe confidence interval|-16.9|||=|0.0896|TWO_SIDED|95.0|-33.02|0.69||The treatment groups were compared using a continuity-corrected chi-square test.|Chi-squared, Corrected|||||0.69|-33.02|=0.0896
72441173|NCT02549170|144395617|SUPERIORITY||||||=|0.002|||||||Wilcoxon Survival Test|||||||=0.002
72441174|NCT02549170|144395618|SUPERIORITY||Least Square Mean|5.2|||=|0.03|TWO_SIDED|95.0|0.5|9.9|||ANCOVA|||||9.9|0.5|=0.030
72441175|NCT01266122|144395659|SUPERIORITY_OR_OTHER||log(Incident Risk Ratio)|-0.95|||<|0.001|TWO_SIDED|95.0|-1.47|-0.44|||Mixed Models Analysis|Mixed effects Poisson regression||Intent to treat analysis||-.44|-1.47|<.001
72441176|NCT01266122|144395660|SUPERIORITY_OR_OTHER||Chi-square statistic|1.39|||=|0.239|TWO_SIDED||||||Chi-squared|||Intent to treat analysis.||||=.239
72441177|NCT03756571|144395662|SUPERIORITY|||||||0.36|||||||t-test, 2 sided|||||||0.36
72441178|NCT03756571|144395663|SUPERIORITY|||||||0.5|||||||t-test, 2 sided|||||||0.50
72441179|NCT03756571|144395664|SUPERIORITY|||||||0.15|||||||t-test, 2 sided|||||||0.15
72441180|NCT03756571|144395665|SUPERIORITY|||||||0.23|||||||t-test, 2 sided|||||||0.23
72441181|NCT03756571|144395666|SUPERIORITY|||||||0.7|||||||t-test, 2 sided|||||||0.70
72441182|NCT03756571|144395667|SUPERIORITY|||||||0.33|||||||t-test, 2 sided|||||||0.33
72441183|NCT03756571|144395668|SUPERIORITY|||||||0.03|||||||Regression, Linear|||||||0.03
72441184|NCT03756571|144395669|SUPERIORITY|||||||0.03|||||||Regression, Linear|||||||0.03
72441185|NCT03756571|144395670|SUPERIORITY|||||||0.08|||||||t-test, 2 sided|||||||0.08
72441186|NCT03756571|144395671|SUPERIORITY|||||||0.18|||||||t-test, 2 sided|||||||0.18
72441187|NCT03756571|144395672|SUPERIORITY|||||||0.15|||||||t-test, 2 sided|||||||0.15
72441188|NCT03756571|144395673|SUPERIORITY|||||||0.8|||||||t-test, 2 sided|||||||0.80
72441189|NCT00595790|144395681|NON_INFERIORITY_OR_EQUIVALENCE|Assessment of non-inferiority of IC51 1x12 mcg vs. IC51 2x6 mcg at Day 56 based on the difference (IC51 1x12 mcg - IC51 2x6 mcg) in SCRs in the PP population. Non-inferiority of IC51 1 x 12 mcg compared to IC51 2 x 6 mcg was accepted if the lower limit of the 95% CI of the adjusted for center SCR difference (IC51 1 x 12 mcg - IC51 2 x 6 mcg) was higher than the noninferiority margin at -10%.|||||>|0.99|||||||Mantel Haenszel|||||||>0.99
72441190|NCT04452318|144395685|SUPERIORITY||Odds Ratio (OR)|0.17|||<|0.0001|TWO_SIDED|95.0|0.09|0.332|||Regression, Logistic|||||0.332|0.090|< 0.0001
72441191|NCT04452318|144395686|SUPERIORITY||Odds Ratio (OR)|0.54|||=|0.038|TWO_SIDED|95.0|0.298|0.966|||Regression, Logistic|||||0.966|0.298|= 0.0380
72441192|NCT04452318|144395688|SUPERIORITY||Odds Ratio (OR)|0.13|||<|0.0001|TWO_SIDED|95.0|0.069|0.236|||Regression, Logistic|||||0.236|0.069|< 0.0001
72441193|NCT04452318|144395688|SUPERIORITY||Odds Ratio (OR)|0.41|||=|0.0024|TWO_SIDED|95.0|0.228|0.728|||Regression, Logistic|||||0.728|0.228|= 0.0024
72441194|NCT04452318|144395689|SUPERIORITY||||||<|0.0001|||||||Stratified Wilcoxon Rank Sum Test|||||||< 0.0001
72441195|NCT04452318|144395690|SUPERIORITY||||||<|0.0001|||||||Stratified Wilcoxon Rank Sum Test|||||||< 0.0001
72441196|NCT04452318|144395690|SUPERIORITY||||||=|0.001|||||||Stratified Wilcoxon Rank Sum Test|||||||= 0.0010
72441197|NCT04452318|144395691|SUPERIORITY||||||<|0.0001|||||||Stratified Wilcoxon Rank Sum Test|||||||< 0.0001
72441198|NCT04452318|144395692|SUPERIORITY||Odds Ratio (OR)|0.31|||<|0.0001|TWO_SIDED|95.0|0.208|0.456|||Multiple Imputation, Logistic Regression|||||0.456|0.208|< 0.0001
72441199|NCT04452318|144395694|SUPERIORITY||Odds Ratio (OR)|0.12|||<|0.0001|TWO_SIDED|95.0|0.051|0.286|||Regression, Logistic|||||0.286|0.051|< 0.0001
72441200|NCT04452318|144395695|SUPERIORITY||||||<|0.0001|||||||Stratified Wilcoxon Rank Sum Test|||||||< 0.0001
72441201|NCT04452318|144395696|SUPERIORITY||Odds Ratio (OR)|0.09|||=|0.001|TWO_SIDED|95.0|0.02|0.37|||Regression, Logistic|||||0.370|0.020|= 0.0010
72441202|NCT04452318|144395697|SUPERIORITY||||||<|0.0001|||||||Stratified Wilcoxon Rank Sum Test|||||||< 0.0001
72441203|NCT04452318|144395700|SUPERIORITY||Difference of LS Means|-2.123|STANDARD_ERROR_OF_MEAN|0.295|<|0.0001|TWO_SIDED|95.0|-2.707|-1.539|||ANOVA|||||-1.539|-2.707|< 0.0001
72441204|NCT04452318|144395701|SUPERIORITY||Difference of LS Means|-2.483|STANDARD_ERROR_OF_MEAN|0.342|<|0.0001|TWO_SIDED|95.0|-3.161|-1.806|||ANOVA|||||-1.806|-3.161|< 0.0001
72441205|NCT04452318|144395702|SUPERIORITY||Difference of LS Mean|-2.428|STANDARD_ERROR_OF_MEAN|0.389|<|0.0001|TWO_SIDED|95.0|-3.196|-1.659|||ANOVA|||||-1.659|-3.196|< 0.0001
72441206|NCT04452318|144395703|SUPERIORITY||Difference of LS Mean|-2.441|STANDARD_ERROR_OF_MEAN|0.381|<|0.0001|TWO_SIDED|95.0|-3.194|-1.688|||ANOVA|||||-1.688|-3.194|< 0.0001
72441207|NCT04452318|144395706|OTHER||||||=|0.0621|||||||Fisher Exact|||Testing if there is an association between the observed results and treatment received||||= 0.0621
72619031|NCT01181128|144768552|SUPERIORITY_OR_OTHER_LEGACY||Bleeding Rate Ratio|0.08|||<|0.001|TWO_SIDED|95.0|0.05|0.13|||negative binomial model|||The null hypothesis for the primary endpoint is no difference between the individualized (tailored) prophylaxis regimen and the on-demand regimen. The sample size of this study was mainly based on clinical rather than statistical considerations. However it was projected to have \> 90% power at the 2-sided 0.05 level of significance to detect a 60% reduction in annualized bleeding episodes, based upon this hypothesis test.||0.13|0.05|<0.001
72441208|NCT04452318|144395707|OTHER||||||=|0.0038|||||||Fisher Exact|||Testing if there is an association between the observed results and treatment received'||||= 0.0038
72441209|NCT04452318|144395710|SUPERIORITY||||||<|0.0001|||||||Stratified Wilcoxon Rank Sum Test|||||||< 0.0001
72441210|NCT04452318|144395718|SUPERIORITY||||||=|0.0273|||||||Stratified Wilcoxon Rank Sum Test|||||||= 0.0273
72496137|NCT00927368|144522119|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority analysis used the 0.5-point noninferiority delta in a 1-tailed test of the treatment effect regression parameter (i.e., testing the null hypothesis that mean stimulating needle minus mean ultrasound alone is greater than 0.5 points).|Mean Difference (Final Values)|-0.28|||<|0.001|TWO_SIDED|95.0|-0.72|0.16||Significance criterion of 0.00347 after adjusting for group sequential design and applying Holm Bonferroni procedure to account for multiple comparisons.|t-test, 2 sided|||The primary analysis for pain was a linear regression model comparing stimulating needle to ultrasound alone on the mean time-weighted average pain score for a patient in the first 48 hours.||0.16|-0.72|< 0.001
72619032|NCT01181128|144768558|SUPERIORITY_OR_OTHER_LEGACY||Bleeding Rate Ratio|0.24|||<|0.001|TWO_SIDED|95.0|0.12|0.46|||negative binomial model|||||0.46|0.12|<0.001
72619033|NCT00185900|144768605|SUPERIORITY|||||||0.01|||||||Chi-squared|||||||0.01
72441211|NCT04452318|144395719|SUPERIORITY||Odds Ratio (OR)|0.54|||=|0.046|TWO_SIDED|95.0|0.299|0.989|||Regression, Logistic|||||0.989|0.299|= 0.0460
72441212|NCT04452318|144395720|SUPERIORITY||Odds Ratio (OR)|0.47|||=|0.0721|TWO_SIDED|95.0|0.207|1.07|||Regression, Logistic|||||1.070|0.207|= 0.0721
72441213|NCT04452318|144395721|SUPERIORITY||||||=|0.026|||||||Stratified Wilcoxon Rank Sum Test|||||||= 0.0260
72441214|NCT04452318|144395722|SUPERIORITY||||||=|0.0614|||||||Stratified Wilcoxon Rank Sum Test|||||||= 0.0614
72441215|NCT04452318|144395723|SUPERIORITY||LS mean difference|-1.461|STANDARD_ERROR_OF_MEAN|0.337|<|0.0001|TWO_SIDED|95.0|-2.127|-0.795|||ANCOVA|||||-0.795|-2.127|< 0.0001
72441216|NCT04452318|144395724|SUPERIORITY||LS mean difference|-0.85|STANDARD_ERROR_OF_MEAN|0.279|=|0.0026|TWO_SIDED|95.0|-1.4|-0.3|||ANCOVA|||||-0.300|-1.400|= 0.0026
72441217|NCT04452318|144395725|SUPERIORITY||LS mean difference|-0.94|STANDARD_ERROR_OF_MEAN|0.193|<|0.0001|TWO_SIDED|95.0|-1.321|-0.559|||ANCOVA|||||-0.559|-1.321|< 0.0001
72441218|NCT04452318|144395726|SUPERIORITY||Difference of LS Mean|-26.045|STANDARD_ERROR_OF_MEAN|6.041|<|0.0001|TWO_SIDED|95.0|-37.973|-14.117|||ANCOVA|||||-14.117|-37.973|< 0.0001
72441219|NCT04452318|144395727|SUPERIORITY||Difference of LS Mean|-1.395|STANDARD_ERROR_OF_MEAN|0.338|<|0.0001|TWO_SIDED|95.0|-2.063|-0.727|||ANCOVA|||||-0.727|-2.063|< 0.0001
72441220|NCT04452318|144395728|SUPERIORITY||||||=|0.0138|||||||Stratified Wilcoxon Rank Sum Test|||||||= 0.0138
72441221|NCT04452318|144395729|OTHER||||||=|0.0292|||||||Fisher Exact|||Testing if there is an association between the observed results and treatment received||||= 0.0292
72441222|NCT04452318|144395730|OTHER||||||=|0.2466|||||||Fisher Exact|||Testing if there is an association between the observed results and treatment received||||= 0.2466
72441223|NCT04452318|144395731|SUPERIORITY||||||=|0.7861|||||||Stratified Wilcoxon Rank Sum test|||||||= 0.7861
72441224|NCT04452318|144395732|SUPERIORITY||||||=|0.0842|||||||Stratified Wilcoxon Rank Sum test|||||||= 0.0842
72441225|NCT03684044|144395852|SUPERIORITY||Median Difference (Net)|-2.7||||0.4666|TWO_SIDED|95.0|-53.4|25.9|||Gehan Wilcoxon|The Gehan Wilcoxon test was used to analyze the TTCI data because the proportional hazards assumption was violated||||25.9|-53.4|0.4666
72441226|NCT03684044|144395853|SUPERIORITY|||||||0.6326|||||||Cochran-Mantel-Haenszel|Statistic was stratified by region, NEWS2 at baseline (≤7, \>7), and time from symptom onset to study treatment (≤48 hours, \>48 hours)||||||0.6326
72441227|NCT03684044|144395854|SUPERIORITY||Mean Difference (Net)|-6.8||||0.3272|TWO_SIDED|95.0|-50.9|17.7|||Gehan Wilcoxon|The Gehan Wilcoxon test was used to analyze the TTCI data because the proportional hazards assumption was violated||||17.7|-50.9|0.3272
72619034|NCT00754559|144768611|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Exact Binomial Test|||Null hypothesis: Proportion of participants reaching LDAS (≤ 3.2) at Week 24 equals (=) expected proportion of 42%.||||<0.001
72619035|NCT00676689|144768656|SUPERIORITY_OR_OTHER_LEGACY||Kaplan-Meier|0.971|STANDARD_ERROR_OF_MEAN|0.02|||TWO_SIDED|95.0|0.889|0.993||||||||0.993|0.889|
72441228|NCT03703336|144395881|NON_INFERIORITY|If the lower limit of the 95% confidence interval (CI) of the ratio of GMCs between the ROTAVIN and ROTAVIN-M1 groups were to be larger than 1/2, ROTAVIN was considered to be non-inferior to the licensed frozen formulation of the vaccine (ROTAVIN-M1).|GMC Ratio|1.38|||||TWO_SIDED|95.0|1.02|1.86|||||Log10-transformed IgA concentrations were used to construct a 2-sided 95% CI for the mean difference between the arms using t-distribution. The mean difference and 95% CI were exponentiated to obtain the GMC ratio and corresponding 95% CI.|||1.86|1.02|
72441229|NCT03703336|144395883|OTHER||Percentage Difference|6.0|||||TWO_SIDED|95.0|-3.57|15.87||||||||15.87|-3.57|
72441230|NCT03703336|144395884|OTHER||Percentage Difference|0.4|||||TWO_SIDED|95.0|-2.4|2.09||||||Percentage Difference on Day 1||2.09|-2.40|
72441231|NCT03703336|144395884|OTHER||Percentage Difference|6.3|||||TWO_SIDED|95.0|-3.19|16.23||||||Percentage Difference on Day 85||16.23|-3.19|
72441232|NCT04629950|144395905|SUPERIORITY|||||||0.395||||||P value not adjusted for multiple comparisons,|t-test, 2 sided|||||||0.395
72441233|NCT04629950|144395905|SUPERIORITY|||||||0.41||||||P values not adjusted for multiple comparisons.|t-test, 2 sided|||||||0.410
72441234|NCT04629950|144395906|SUPERIORITY|||||||0.691|||||||Fisher Exact|||||||0.691
72441235|NCT04629950|144395906|SUPERIORITY|||||||1||||||P values not adjusted for multiple comparisons.|Fisher Exact|||||||1
72441236|NCT04629950|144395907|SUPERIORITY|||||||0.758|||||||t-test, 2 sided|P value not adjusted for multiple comparisons,||||||0.758
72441237|NCT04629950|144395907|SUPERIORITY|||||||0.247||||||P values not adjusted for multiple comparisons.|Fisher Exact|||Data represent change values.||||0.247
72504755|NCT03114969|144540503|SUPERIORITY||Odds Ratio (OR)|4.728|||<|0.001|TWO_SIDED|95.0|2.388|9.364||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta+\[Relvar Ellipta+LAMA\] as comparator.|||9.364|2.388|<0.001
72441238|NCT04629950|144395908|SUPERIORITY|||||||0.316||||||P values were not adjusted for multiple comparisons.|t-test, 2 sided|||||||0.316
72441239|NCT04629950|144395908|SUPERIORITY|||||||0.605||||||P values not adjusted for multiple comparisons.|t-test, 2 sided|||Data represent change values.||||0.605
72441240|NCT04629950|144395909|SUPERIORITY|||||||0.192||||||P value not adjusted for multiple comparisons,|t-test, 2 sided|||Mean Reduction in Average Itch||||0.192
72441241|NCT04629950|144395909|SUPERIORITY|||||||0.392||||||P value not adjusted for multiple comparisons,|t-test, 2 sided|||Mean Reduction in Average Itch. Data represent change values.||||0.392
72441242|NCT04629950|144395909|SUPERIORITY|||||||0.347||||||P values not adjusted for multiple comparisons.|t-test, 2 sided|||Mean Reduction in Maximum Itch||||0.347
72441243|NCT04629950|144395909|SUPERIORITY|||||||0.572||||||P value not adjusted for multiple comparisons,|t-test, 2 sided|||Mean Reduction in Maximum Itch. Data represent change values.||||0.572
72441244|NCT04629950|144395910|OTHER|||||||0.359|||||||Wilcoxon (Mann-Whitney)|||||||0.359
72441245|NCT04629950|144395911|OTHER|||||||0.141|||||||Wilcoxon (Mann-Whitney)|||||||0.141
72441246|NCT04629950|144395912|OTHER|||||||0.582|||||||Wilcoxon (Mann-Whitney)|||||||0.582
72441247|NCT04629950|144395913|OTHER|||||||0.713|||||||Wilcoxon (Mann-Whitney)|||||||0.713
72441248|NCT04629950|144395914|OTHER|||||||0.346|||||||Wilcoxon (Mann-Whitney)|||||||0.346
72441249|NCT04629950|144395915|OTHER|||||||0.149|||||||Wilcoxon (Mann-Whitney)|||||||0.149
72441250|NCT04629950|144395916|OTHER|||||||0.221|||||||Wilcoxon (Mann-Whitney)|||Analysis for Average Itch Over the Preceding 3 Days||||0.221
72441251|NCT04629950|144395916|OTHER|||||||0.286|||||||Wilcoxon (Mann-Whitney)|||Analysis is for the Maximum Itch of the Preceding 7 Days||||0.286
72441252|NCT04629950|144395917|OTHER|||||||1|||||||Wilcoxon (Mann-Whitney)|||Analysis for Average Itch Over the Preceding 3 Days||||1
72441253|NCT04629950|144395917|OTHER|||||||1|||||||Wilcoxon (Mann-Whitney)|||Analysis is for the Maximum Itch of the Preceding 7 Days||||1
72441254|NCT02088853|144395924|SUPERIORITY|Wilcoxon test|||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
72441255|NCT02088853|144395925|SUPERIORITY||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
72441256|NCT02088853|144395926|SUPERIORITY|||||||0.05|||||||Wilcoxon (Mann-Whitney)|||||||0.05
72441257|NCT01198145|144395930|SUPERIORITY_OR_OTHER_LEGACY|||||||0.41|||||||Wilcoxon (Mann-Whitney)|||||||0.41
72441258|NCT01198145|144395931|SUPERIORITY_OR_OTHER_LEGACY|||||||0.23|||||||Chi-squared|||Comparing Tenesmus During RT||||0.23
72441259|NCT01198145|144395931|SUPERIORITY_OR_OTHER_LEGACY|||||||0.64|||||||Chi-squared|||Comparing Tenesmus after RT||||0.64
72504756|NCT03114969|144540503|SUPERIORITY||Odds Ratio (OR)|2.957||||0.002|TWO_SIDED|95.0|1.473|5.936||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta+\[Relvar Ellipta+LAMA\] as comparator.|||5.936|1.473|0.002
72504757|NCT03114969|144540504|SUPERIORITY||Odds Ratio (OR)|2.404||||0.045|TWO_SIDED|95.0|1.018|5.676||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator.|||5.676|1.018|0.045
72504758|NCT03114969|144540504|SUPERIORITY||Odds Ratio (OR)|1.823||||0.172|TWO_SIDED|95.0|0.77|4.319||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator.|||4.319|0.770|0.172
72504759|NCT03114969|144540504|SUPERIORITY||Odds Ratio (OR)|2.989||||0.016|TWO_SIDED|95.0|1.229|7.272||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Incruse/Anoro Ellipta as comparator.|||7.272|1.229|0.016
72441260|NCT01198145|144395931|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3|||||||Chi-squared|||Comparing abdominal pain during RT.||||0.30
72441261|NCT01198145|144395931|SUPERIORITY_OR_OTHER_LEGACY|||||||0.02|||||||Chi-squared|||Comparing abdominal pain after RT||||0.02
72441262|NCT01198145|144395931|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7|||||||Chi-squared|||Comparing constipation during RT||||0.70
72441263|NCT01198145|144395931|SUPERIORITY_OR_OTHER_LEGACY|||||||0.63|||||||Chi-squared|||Comparing constipation after RT||||0.63
72441264|NCT01198145|144395931|SUPERIORITY_OR_OTHER_LEGACY|||||||0.44|||||||Chi-squared|||Comparing diarrhea during RT||||0.44
72441265|NCT01198145|144395931|SUPERIORITY_OR_OTHER_LEGACY|||||||0.48|||||||Chi-squared|||Comparing diarrhea after RT||||0.48
72496138|NCT00927368|144522119|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority analysis used the 0.5-point noninferiority delta in a 1-tailed test of the treatment effect regression parameter (i.e., testing the null hypothesis that mean ultrasound alone minus mean stimulating needle is greater than 0.5 points).|Mean Difference (Final Values)|0.28||||0.11|TWO_SIDED|95.0|-0.16|0.72||Significance criterion of 0.02082 after adjusting for group sequential design and applying Holm Bonferroni procedure to account for multiple comparisons.|t-test, 2 sided|||The primary analysis for pain was a linear regression model comparing ultrasound alone to stimulating needle on the mean time-weighted average pain score for a patient in the first 48 hours.||0.72|-0.16|0.11
72496139|NCT00927368|144522120|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority analysis used the 0.5-point noninferiority delta in a 1-tailed test of the treatment effect regression parameter (i.e., testing the null hypothesis that mean stimulating catheter minus mean stimulating needle is greater than 0.5 points).|Mean Difference (Final Values)|5.0||||0.04|TWO_SIDED|95.0|-17.0|34.0||Significance criterion of 0.02082 after adjusting for group sequential design and applying Holm Bonferroni procedure to account for multiple comparisons.|t-test, 2 sided|||The primary analysis for opioid was a linear regression model comparing stimulating catheter to stimulating needle on the log of cumulative opioid consumption score for a patient in the first 48 hours.||34|-17|0.04
72559256|NCT01694563|144648116|SUPERIORITY||Clopper-Pearson|90.0|||||TWO_SIDED|90.0|||||||90% confidence interval calculated using the Clopper-Pearson method.|Secondary success was defined as freedom from AF regardless of antiarrhythmic drug usage at 24 months post-operatively.||||
72559257|NCT01694563|144648116|SUPERIORITY||Clopper-Pearson|90.0|||||TWO_SIDED|90.0||||||||Secondary success was defined as freedom from AF regardless of antiarrhythmic drug usage at 36 months post-operatively.|90% confidence interval using the Clopper-Pearson method.|||
72441266|NCT01198145|144395931|SUPERIORITY_OR_OTHER_LEGACY|||||||0.38|||||||Chi-squared|||Comparing rectal bleeding during RT||||0.38
72559258|NCT03068780|144648125|SUPERIORITY||Odds Ratio (OR)|1.84||||0.013|TWO_SIDED|95.0|1.02|3.3||P-value adjusted with CHW method using CMH test statistics based on a test stratified by EB subtype and target wound size class estimated separately before and after the interim analysis for sample size re-estimation.Threshold of superiority p\<0.05.|Cui, Hung, Wang (CHW) approach|Primary efficacy endpoint was first assessed with the CMH test, but the final statistical analysis was performed based on the CHW approach.|The CMH test statistic from the data until the interim analysis (IA) and the CMH test statistic of the data after the IA must be calculated separately. The results are then combined using the CHW weighted approach to one test-statistic.|||3.30|1.02|0.013
72441267|NCT01198145|144395931|SUPERIORITY_OR_OTHER_LEGACY|||||||0.15|||||||Chi-squared|||||||0.15
72441268|NCT01198145|144395932|SUPERIORITY_OR_OTHER_LEGACY|||||||0.56|||||||Wilcoxon (Mann-Whitney)|||Result comparing Arm I and Arm II during RT.||||0.56
72441269|NCT01198145|144395932|SUPERIORITY_OR_OTHER_LEGACY|||||||0.74|||||||Wilcoxon (Mann-Whitney)|||Result comparing Arm I and Arm II after RT.||||0.74
72441270|NCT00891436|144395939|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.0|STANDARD_ERROR_OF_MEAN|0.5|>|0.1||95.0|||||t-test, 2 sided|||paired t-test was used for the data analysis||||>0.1
72441271|NCT00891436|144395939|NON_INFERIORITY_OR_EQUIVALENCE|t-test showed no different between the 2 groups.|Mean Difference (Final Values)|2.0|STANDARD_ERROR_OF_MEAN|0.5|>|0.1||95.0|||||t-test, 2 sided|||||||>0.1
72441272|NCT01381406|144395947|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.772||||0.007|TWO_SIDED|95.0|0.641|0.93||COPD-Related Adjusted Multivariate Outcomes in the Follow-Up Period by Cohort (reference cohort = TIO) for Any COPD Exacerbation|Regression, Logistic|||||0.930|0.641|0.007
72441273|NCT01381406|144395947|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.622||||0.146|TWO_SIDED|95.0|0.328|1.18||COPD-Related Adjusted Multivariate Outcomes in the Follow-Up Period by Cohort (reference cohort = TIO) for Severe COPD Exacerbations|Regression, Logistic|||||1.180|0.328|0.146
72441274|NCT01381406|144395947|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.763||||0.013|TWO_SIDED|95.0|0.646|0.949||COPD-Related Adjusted Multivariate Outcomes in the Follow-Up Period by Cohort (reference cohort = TIO) for Moderate COPD Exacerbations|Regression, Logistic|||||0.949|0.646|0.013
72441275|NCT03447249|144395950|SUPERIORITY||Least Squares (LS) Mean Difference|14.0|||<|0.0001|TWO_SIDED|95.0|12.4|15.7|||Mixed-effects model for repeated measure|||The data presented for Primary endpoint was based on interim analysis at Week 4.||15.7|12.4|<0.0001
72441276|NCT03447249|144395951|SUPERIORITY||LS Mean Difference|14.2|||<|0.0001|TWO_SIDED|95.0|12.6|15.7|||Mixed-effects model for repeated measure|||||15.7|12.6|<0.0001
72441277|NCT03447249|144395952|SUPERIORITY||Rate ratio|0.14|||<|0.0001|TWO_SIDED|95.0|0.09|0.24|||Negative binomial regression model|||||0.24|0.09|<0.0001
72441278|NCT03447249|144395953|SUPERIORITY||LS Mean Difference|-44.6|||<|0.0001|TWO_SIDED|95.0|-47.2|-41.9|||Mixed-effects model for repeated measure|||||-41.9|-47.2|<0.0001
72441279|NCT03447249|144395954|SUPERIORITY||LS Mean Difference|20.1|||<|0.0001|TWO_SIDED|95.0|17.2|23.0|||Mixed-effects model for repeated measure|||||23.0|17.2|<0.0001
72441280|NCT03447249|144395955|SUPERIORITY||LS Mean Difference|1.11|||<|0.0001|TWO_SIDED|95.0|0.91|1.31|||Mixed-effects model for repeated measure|||||1.31|0.91|<0.0001
72441281|NCT03447249|144395956|SUPERIORITY||LS Mean Difference|-43.4|||<|0.0001|TWO_SIDED|95.0|-46.3|-40.5|||Mixed-effects model for repeated measure|||||-40.5|-46.3|<0.0001
72441282|NCT03447249|144395957|SUPERIORITY||LS Mean Difference|17.9|||<|0.0001|TWO_SIDED|95.0|14.5|21.3|||Mixed-effects model for repeated measure|||||21.3|14.5|<0.0001
72441283|NCT03447249|144395959|SUPERIORITY||LS Mean Difference|0.39|||||TWO_SIDED|95.0|0.24|0.54||||||||0.54|0.24|
72559259|NCT03068780|144648126|SUPERIORITY|||||||0.302||||||Threshold of superiority is p\<0.05|Chi-squared|||||||0.302
72441284|NCT03447249|144395960|SUPERIORITY||LS Mean Difference|3.2|||||TWO_SIDED|95.0|2.7|3.8||||||||3.8|2.7|
72441285|NCT00419341|144395979|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority of SCIG:IVIG treatment was concluded if the lower GMR confidence limit was 0.8 or more. With 18 evaluable subjects, the power to show this non-inferiority was calculated to be 85% based on the assumptions of an intra-individual variability with a coefficient of variation (CV) = 25% and a GMR equal to or greater than 1.|Geometric mean ratio (GMR)|1.002|||||TWO_SIDED|90.0|0.951|1.055||No P-value is provided as non-inferiority was assessed by the CI of the GMR.|t-test, 2 sided|Based on log-transformed individual differences.|Geometric mean ratio SCIG:IVIG non-inferiority was concluded if the lower GMR confidence limit was 0.8 or more|Individual sAUC values (standardized to a 7-day period) of the IV and adjusted SC sampling periods in each individual subject were log transformed and a parametric 2-sided 90% confidence interval (CI) for the mean of the individual differences was obtained. Back-transformation of the mean and its CI produced the geometric mean ratio (GMR) and its respective 90% CI.||1.055|0.951|
72441286|NCT02020252|144396013|SUPERIORITY|||||||0.307||||||This is for the receptivity sub-scale, and the comparison between pre and post-test scores.|t-test, 2 sided|This was a paired t-test.||||||.307
72441287|NCT02020252|144396013|SUPERIORITY|||||||0.009||||||This is for the willingness sub-scale, and the comparison between pre and posttest scores.|t-test, 2 sided|This was a paired t-test.||||||.009
72441288|NCT02020252|144396013|SUPERIORITY||||||<|0.001||||||This is for knowledge sub scale, and the comparison between pre and posttest scores.|t-test, 2 sided|A paired t-test.||||||<.001
72441289|NCT02020252|144396013|SUPERIORITY|||||||0.004||||||This is for the positive attitudes sub scale, and the comparison between pre and posttest scores.|t-test, 2 sided|This was a paired t-test.||||||.004
72441290|NCT02020252|144396013|SUPERIORITY||||||<|0.001||||||This was for the self-efficacy sub scale, and the comparison between pre and posttest scores.|t-test, 2 sided|This was a paired t-test.||||||<.001
72441291|NCT00879060|144396020|OTHER||Mean Difference (Final Values)|0.0||||1|TWO_SIDED|||||An a priori threshold for statistical significance was determined at an alpha level of 0.05.|t-test, 2 sided|||A two-sample T-test was used to compare continuous variable PINP (serum marker of collagen formation/degradation) between spironolactone treated and placebo groups at baseline.||||1.0
72441292|NCT00879060|144396020|OTHER||Mean Difference (Final Values)|0.2||||0.8|TWO_SIDED|||||An a priori threshold for statistical significance was determined at an alpha level of 0.05.|t-test, 2 sided|||A two-sample T-test was used to compare continuous variable PIIINP (serum marker of collagen formation/degradation) between spironolactone treated and placebo groups at baseline.||||0.8
72441293|NCT00879060|144396020|OTHER||Mean Difference (Final Values)|0.3||||0.3|TWO_SIDED|||||An a priori threshold for statistical significance was determined at an alpha level of 0.05.aseline.|t-test, 2 sided|||A two-sample T-test was used to compare continuous variable ICTP (serum marker of collagen formation/degradation) between spironolactone treated and placebo groups at baseline.||||0.3
72504661|NCT02495077|144540088|SUPERIORITY||Mean Difference (Final Values)|-1.35||||0.601|TWO_SIDED|95.0|-6.41|3.72|||Mixed Models Analysis|||Day 30. Mean eGFR of the two treatment groups was compared. The p-value, estimated day 30 eGFR within each treatment group, estimate of the treatment group difference, and estimated 95% confidence interval result from a repeated measures mixed model using available eGFR data from months 1, 3, 6, 12, 18, and 24 to compare the experimental group to the control group at day 30. Random effects for the intercept and eGFR collection day were utilized in the model.||3.72|-6.41|0.601
72619036|NCT00676689|144768657|SUPERIORITY_OR_OTHER_LEGACY||Kaplan-Meier|0.941|STANDARD_ERROR_OF_MEAN|0.028|||TWO_SIDED|95.0|0.851|0.978||||||Freedom from Major Adverse Cardiovascular and Cerebrovascular Event (MACCE) at 6 months in the valve implant population.||0.978|0.851|
72441294|NCT00879060|144396020|OTHER||Absolute difference|0.0||||1|TWO_SIDED|||||An a priori threshold for statistical significance was determined at an alpha level of 0.05.|t-test, 2 sided|||A two-sample T-test was used to compare the absolute differences in change from baseline to 12 months in continuous variable PINP (serum marker of collagen formation/degradation) between spironolactone treated and placebo groups.||||1.0
72441295|NCT00879060|144396021|OTHER||Absolute difference|1.2||||0.7|TWO_SIDED|||||An a priori threshold for statistical significance was determined at an alpha level of 0.05.|t-test, 2 sided|||A two-sample T-test was used to compare the absolute differences in change from baseline to 12 months in continuous variable peak oxygen consumption with exercise (peak VO2) between spironolactone treated and placebo groups.||||0.7
72441296|NCT00879060|144396022|OTHER||Absolute difference|0.0||||0.8|TWO_SIDED|||||An a priori threshold for statistical significance was determined at an alpha level of 0.05.|t-test, 2 sided|||A two-sample T-test was used to compare the absolute differences in change from baseline to 12 months in continuous variable New York Heart Association (NYHA) Functional Class between spironolactone treated and placebo groups.||||0.8
72441297|NCT00879060|144396023|OTHER||Absolute difference|1.4||||1|TWO_SIDED|||||An a priori threshold for statistical significance was determined at an alpha level of 0.05.|t-test, 2 sided|||A two-sample T-test was used to compare the absolute differences in change from baseline to 12 months in continuous variable Septal E/e' between spironolactone treated and placebo groups.||||1.0
72441298|NCT00879060|144396024|OTHER||Absolute difference|0.2||||0.7|TWO_SIDED|||||An a priori threshold for statistical significance was determined at an alpha level of 0.05.|t-test, 2 sided|||A two-sample T-test was used to compare the absolute differences in change from baseline to 12 months in continuous variable percentage of left ventricular mass (%LV) between spironolactone treated and placebo groups.||||0.7
72441299|NCT00879060|144396025|OTHER||Absolute difference|0.9||||0.4|TWO_SIDED|||||An a priori threshold for statistical significance was determined at an alpha level of 0.05.|t-test, 2 sided|||A two-sample T-test was used to compare the absolute differences in change from baseline to 12 months in continuous variable maximum left ventricular wall thickness (Max LV) between spironolactone treated and placebo groups.||||0.4
72441300|NCT00879060|144396026|OTHER||Absolute difference|5.7||||0.7|TWO_SIDED|||||An a priori threshold for statistical significance was determined at an alpha level of 0.05.|t-test, 2 sided|||A two-sample T-test was used to compare the absolute differences in change from baseline to 12 months in continuous variable left ventricular end-diastolic (LVED) cavity size between spironolactone treated and placebo groups.||||0.7
72619037|NCT00676689|144768658|SUPERIORITY_OR_OTHER_LEGACY||Percentage|87.9|||||TWO_SIDED|||||||||Overall functional improvement at 6 months for patients in the valve implant population with baseline and 6 month data.||||
72441301|NCT00879060|144396027|OTHER||Absolute difference|0.1||||0.8|TWO_SIDED|||||An a priori threshold for statistical significance was determined at an alpha level of 0.05.|t-test, 2 sided|||A two-sample T-test was used to compare the absolute differences in change from baseline to 12 months in continuous variable left atrial dimension between spironolactone treated and placebo groups.||||0.8
72441302|NCT02539225|144396028|SUPERIORITY|||||||0.698|||||||Stratified Log Rank|||||||0.698
72441303|NCT02539225|144396029|SUPERIORITY|||||||0.549|||||||Log Rank Stratified|||||||0.549
72441304|NCT02539225|144396030|SUPERIORITY|||||||0.548|||||||Log Rank Stratified|||||||0.548
72441305|NCT02539225|144396031|SUPERIORITY||Odds Ratio (OR)|1.374||||0.402|TWO_SIDED|80.0|0.844|2.236|||Cochran-Mantel-Haenszel|||||2.236|0.844|0.402
72441306|NCT02539225|144396032|SUPERIORITY||Odds Ratio (OR)|1.527||||0.501|TWO_SIDED|80.0|0.68|3.433|||Cochran-Mantel-Haenszel|||||3.433|0.680|0.501
72441307|NCT04043455|144396112|SUPERIORITY||Least square mean difference|-0.19|STANDARD_ERROR_OF_MEAN|0.407|=|0.65|TWO_SIDED|95.0|-0.99|0.62|||Mixed Models Analysis|||Treatment comparison between Olorinab 10 mg and placebo using least square mean difference and 95% confidence interval (CI) has been presented.||0.62|-0.99|=0.650
72441308|NCT04043455|144396112|SUPERIORITY||Least square mean difference|-0.32|STANDARD_ERROR_OF_MEAN|0.409|=|0.439|TWO_SIDED|95.0|-1.12|0.49|||Mixed Models Analysis|||Treatment comparison between Olorinab 25 mg and placebo using least square mean difference and 95% CI has been presented.||0.49|-1.12|=0.439
72496140|NCT00927368|144522120|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority analysis used the 0.5-point noninferiority delta in a 1-tailed test of the treatment effect regression parameter (i.e., testing the null hypothesis that mean stimulating needle minus mean stimulating catheter is greater than 0.5 points).|Mean Difference (Final Values)|-5.0||||0.002|TWO_SIDED|95.0|-25.0|21.0||Significance criterion of 0.00347 after adjusting for group sequential design and applying Holm Bonferroni procedure to account for multiple comparisons.|t-test, 2 sided|||The primary analysis for opioid was a linear regression model comparing stimulating needle to stimulating catheter on the log of cumulative opioid consumption score for a patient in the first 48 hours.||21|-25|0.002
72496141|NCT00927368|144522120|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority analysis used the 0.5-point noninferiority delta in a 1-tailed test of the treatment effect regression parameter (i.e., testing the null hypothesis that mean stimulating catheter minus mean ultrasound alone is greater than 0.5 points).|Mean Difference (Final Values)|3.0||||0.03|TWO_SIDED|95.0|-25.0|21.0||Significance criterion of 0.01735 after adjusting for group sequential design and applying Holm Bonferroni procedure to account for multiple comparisons.|t-test, 2 sided|||The primary analysis for opioid was a linear regression model comparing stimulating catheter to ultrasound alone on the log of cumulative opioid consumption score for a patient in the first 48 hours.||21|-25|0.03
72496142|NCT00927368|144522120|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority analysis used the 0.5-point noninferiority delta in a 1-tailed test of the treatment effect regression parameter (i.e., testing the null hypothesis that mean ultrasound alone minus mean stimulating catheter is greater than 0.5 points).|Mean Difference (Final Values)|-3.0||||0.005|TWO_SIDED|95.0|-24.0|23.0||Significance criterion of 0.00694 after adjusting for group sequential design and applying Holm Bonferroni procedure to account for multiple comparisons.|t-test, 2 sided|||The primary analysis for opioid was a linear regression model comparing ultrasound alone to stimulating catheter on the log of cumulative opioid consumption score for a patient in the first 48 hours.||23|-24|0.005
72441309|NCT04043455|144396112|SUPERIORITY||Least square mean difference|-0.55|STANDARD_ERROR_OF_MEAN|0.401|=|0.172|TWO_SIDED|95.0|-1.34|0.24|||Mixed Models Analysis|||Treatment comparison between Olorinab 50 mg and placebo using least square mean difference and 95% CI has been presented.||0.24|-1.34|=0.172
72441310|NCT04043455|144396119|SUPERIORITY||Odds Ratio (OR)|1.156||||0.659|TWO_SIDED|95.0|-0.019|2.331|||Cochran-Mantel-Haenszel|||Treatment comparison between Olorinab 10 mg and placebo using Odds ratio and 95% CI has been presented.||2.331|-0.019|0.659
72441311|NCT04043455|144396119|SUPERIORITY||Odds Ratio (OR)|1.248||||0.557|TWO_SIDED|95.0|-0.04|2.535|||Cochran-Mantel-Haenszel|||Treatment comparison between Olorinab 25 mg and placebo using Odds ratio and 95% CI has been presented.||2.535|-0.040|0.557
72441312|NCT04043455|144396119|SUPERIORITY||Odds Ratio (OR)|1.245||||0.541|TWO_SIDED|95.0|0.027|2.462|||Cochran-Mantel-Haenszel|||Treatment comparison between Olorinab 50 mg and placebo using Odds ratio and 95% CI has been presented.||2.462|0.027|0.541
72441313|NCT04043455|144396120|SUPERIORITY||Odds Ratio (OR)|1.234||||0.529|TWO_SIDED|95.0|-0.001|2.468|||Cochran-Mantel-Haenszel|||Treatment comparison between Olorinab 10 mg and placebo using Odd's ratio and 95% CI has been presented.||2.468|-0.001|0.529
72441314|NCT04043455|144396120|SUPERIORITY||Odds Ratio (OR)|1.123||||0.73|TWO_SIDED|95.0|0.015|2.232|||Cochran-Mantel-Haenszel|||Treatment comparison between Olorinab 25 mg and placebo using Odd's ratio and 95% CI has been presented.||2.232|0.015|0.730
72441315|NCT04043455|144396120|SUPERIORITY||Odds Ratio (OR)|1.226||||0.548|TWO_SIDED|95.0|0.025|2.428|||Cochran-Mantel-Haenszel|||Treatment comparison between Olorinab 50 mg and placebo using Odd's ratio and 95% CI has been presented.||2.428|0.025|0.548
72441316|NCT04043455|144396121|SUPERIORITY||Least square mean difference|-2.42|STANDARD_ERROR_OF_MEAN|6.189||0.696|TWO_SIDED|95.0|-14.61|9.76|||Mixed Models Analysis|||Treatment comparison between Olorinab 10 mg and placebo using least square mean difference and 95% CI has been presented.||9.76|-14.61|0.696
72441317|NCT04043455|144396121|SUPERIORITY||Least square mean difference|-3.25|STANDARD_ERROR_OF_MEAN|6.222||0.602|TWO_SIDED|95.0|-15.51|9.0|||Mixed Models Analysis|||Treatment comparison between Olorinab 25 mg and placebo using least square mean difference and 95% CI has been presented.||9.00|-15.51|0.602
72441318|NCT04043455|144396121|SUPERIORITY||Least square mean difference|-3.96|STANDARD_ERROR_OF_MEAN|6.088||0.516|TWO_SIDED|95.0|-15.95|8.03|||Mixed Models Analysis|||Treatment comparison between Olorinab 50 mg and placebo using least square mean difference and 95% CI has been presented.||8.03|-15.95|0.516
72441319|NCT04043455|144396122|SUPERIORITY||Least square mean difference|0.08|STANDARD_ERROR_OF_MEAN|0.305||0.804|TWO_SIDED|95.0|-0.53|0.68|||Mixed Models Analysis|||Treatment comparison between Olorinab 10 mg and placebo using least square mean difference and 95% CI has been presented.||0.68|-0.53|0.804
72441320|NCT04043455|144396122|SUPERIORITY||Least square mean difference|-0.15|STANDARD_ERROR_OF_MEAN|0.308||0.618|TWO_SIDED|95.0|-0.76|0.45|||Mixed Models Analysis|||Treatment comparison between Olorinab 25 mg and placebo using least square mean difference and 95% CI has been presented.||0.45|-0.76|0.618
72441321|NCT04043455|144396122|SUPERIORITY||Least square mean difference|0.12|STANDARD_ERROR_OF_MEAN|0.301||0.687|TWO_SIDED|95.0|-0.47|0.71|||Mixed Models Analysis|||Treatment comparison between Olorinab 50 mg and placebo using least square mean difference and 95% CI has been presented.||0.71|-0.47|0.687
72441322|NCT02980276|144396179|EQUIVALENCE|Two-sided test comparing observed risk difference to zero.|Risk Difference (RD)|-6.9||||0.13|TWO_SIDED|95.0|-15.1|1.4||The primary analysis, as per sample size calculation, was a two-sample comparison of reduction in the proportion of women needing insulin between treatment and control arms using an exact test for a binomial response.|Risk difference||Units are %|The primary analysis, as per sample size calculation, was a two-sample comparison of reduction in the proportion of women needing insulin between treatment and control arms using an exact test for a binomial response.||1.4|-15.1|0.13
72441323|NCT02980276|144396180|EQUIVALENCE|Two-sided test comparing observed risk difference to zero.|Risk Difference (RD)|-12.7||||0.004|TWO_SIDED|95.0|-21.2|-4.3|||Risk difference||Units are %|||-4.3|-21.2|0.004
72441324|NCT02980276|144396181|SUPERIORITY|||||||0.001|||||||Log Rank|Median survival times could not be calculated; time to insulin initiation would be censored at delivery in \>50% of participants in treatment group.||||||0.001
72441325|NCT02980276|144396182|EQUIVALENCE|Two-sided test comparing observed odds ratio to 1.|Odds Ratio, log|0.61||||0.005|TWO_SIDED|95.0|0.43|0.86|||Regression, Logistic|Unadjusted|Unadjusted|||0.86|0.43|0.005
72441326|NCT02980276|144396182|EQUIVALENCE|Two-sided test comparing observed odds ratio to 1.|Odds Ratio (OR)|0.56||||0.003|TWO_SIDED|95.0|0.38|0.82|||Regression, Logistic|Adjusted|Adjusted|||0.82|0.38|0.003
72441327|NCT02980276|144396183|EQUIVALENCE|Two-sided test comparing observed odds ratio to 1.|Odds Ratio (OR)|0.78||||0.178|TWO_SIDED|95.0|0.55|1.12|||Regression, Logistic||Unadjusted|||1.12|0.55|0.178
72441328|NCT02980276|144396183|EQUIVALENCE|Two-sided test comparing observed odds ratio to 1.|Odds Ratio (OR)|0.72||||0.105|TWO_SIDED|95.0|0.48|1.07||Two-sided test comparing observed odds ratio to 1.|Regression, Logistic||Adjusted|||1.07|0.48|0.105
72441329|NCT02980276|144396184|EQUIVALENCE|Two-sided test comparing observed mean difference to zero.|Mean Difference (Final Values)|-3.7||||0.17|TWO_SIDED|95.0|-9.3|1.7|||t-test, 2 sided|||||1.7|-9.3|0.17
72441330|NCT02980276|144396185|EQUIVALENCE|Two-sided test comparing observed mean difference ratio to zero.|Mean Difference (Final Values)|-1.2||||0.003|TWO_SIDED|95.0|-1.99|-0.42|||t-test, 2 sided|||||-0.42|-1.99|0.003
72441331|NCT02980276|144396186|EQUIVALENCE|Two-sided test comparing observed odds ratio to 1.|Odds Ratio (OR)|1.21||||0.99|TWO_SIDED|95.0|0.65|1.55|||Regression, Logistic|||||1.55|0.65|0.99
72441332|NCT02980276|144396187|EQUIVALENCE|Two-sided test comparing observed odds ratio to 1.|Odds Ratio (OR)|0.96||||0.911|TWO_SIDED|95.0|0.46|2.0|||Regression, Logistic|||||2|0.46|0.911
72441333|NCT02980276|144396188|EQUIVALENCE|Two-sided test comparing observed odds ratio to 1.|Odds Ratio (OR)|0.82||||0.519|TWO_SIDED|95.0|0.44|1.51|||Regression, Logistic|||||1.51|0.44|0.519
72441334|NCT02980276|144396189|EQUIVALENCE|Two-sided test comparing observed mean difference to zero.|Mean Difference (Final Values)|0.0||||0.66|TWO_SIDED|95.0|-0.3|0.2|||t-test, 2 sided|||||0.2|-0.3|0.66
72441335|NCT02980276|144396190|EQUIVALENCE|Two-sided test comparing observed odds ratio to 1.|Odds Ratio (OR)|1.21||||0.367|TWO_SIDED|95.0|0.8|1.85|||Regression, Logistic|Unadjusted|Unadjusted|||1.85|0.8|0.367
72441336|NCT02980276|144396190|EQUIVALENCE|Two-sided test comparing observed odds ratio to 1.|Odds Ratio (OR)|1.22||||0.359|TWO_SIDED|95.0|0.8|1.87|||Regression, Logistic|Adjusted|Adjusted|||1.87|0.8|0.359
72441337|NCT02980276|144396191|EQUIVALENCE|Two-sided test comparing observed risk difference to zero.|Risk Difference (RD)|-6.5||||1|TWO_SIDED|95.0|-13.9|12.9|||Risk difference||Units are %|||12.9|-13.9|1.0
72441338|NCT02980276|144396192|EQUIVALENCE|Two-sided test comparing observed odds ratio to 1.|Odds Ratio (OR)|0.89||||0.603|TWO_SIDED|95.0|0.56|1.39|||Regression, Logistic|Unadjusted|Unadjusted|||1.39|0.56|0.603
72441339|NCT02980276|144396192|EQUIVALENCE|Two-sided test comparing observed odds ratio to 1.|Odds Ratio (OR)|0.89||||0.621|TWO_SIDED|95.0|0.57|1.4|||Regression, Logistic|Adjusted|Adjusted|||1.4|0.57|0.621
72441340|NCT02980276|144396193|EQUIVALENCE|Two-sided test comparing observed odds ratio to 1.|Odds Ratio (OR)|0.89||||0.739|TWO_SIDED|95.0|0.45|1.76|||Regression, Logistic|Unadjusted|Unadjusted|||1.76|0.45|0.739
72441341|NCT02980276|144396193|EQUIVALENCE|Two-sided test comparing observed odds ratio to 1.|Odds Ratio (OR)|0.92||||0.812|TWO_SIDED|95.0|0.46|1.84|||Regression, Logistic|Adjusted|Adjusted|||1.84|0.46|0.812
72441342|NCT02980276|144396194|EQUIVALENCE|Two-sided test comparing observed odds ratio to 1.|Odds Ratio (OR)|1.84||||0.282|TWO_SIDED|95.0|0.63|6.04|||Regression, Logistic|Unadjusted|Unadjusted|Unadjusted||6.04|0.63|0.282
72441343|NCT02980276|144396194|EQUIVALENCE|Two-sided test comparing observed odds ratio to 1.|Odds Ratio (OR)|2.14||||0.196|TWO_SIDED|95.0|0.7|7.38|||Regression, Logistic||Adjusted|||7.38|0.7|0.196
72441344|NCT02980276|144396195|EQUIVALENCE|Two-sided test comparing observed odds ratio to 1.|Odds Ratio (OR)|0.53||||0.058|TWO_SIDED|95.0|0.27|1.01|||Regression, Logistic|Unadjusted||||1.01|0.27|0.058
72441345|NCT02980276|144396195|EQUIVALENCE|Two-sided test comparing observed odds ratio to 1.|Odds Ratio (OR)|0.53||||0.061|TWO_SIDED|95.0|0.27|1.02|||Regression, Logistic|Adjusted||||1.02|0.27|0.061
72441346|NCT02980276|144396196|EQUIVALENCE|Two-sided test comparing observed risk difference to zero.|Risk Difference (RD)|-4.5||||0.24|TWO_SIDED|95.0|-11.6|2.5|||Risk difference||Units are %|||2.5|-11.6|0.24
72441347|NCT02980276|144396196|EQUIVALENCE|Two-sided test comparing observed risk difference to zero.|Risk Difference (RD)|0.81||||0.24|TWO_SIDED|95.0|0.59|1.12|||Regression, Logistic||Units are %|||1.12|0.59|0.24
72441348|NCT02980276|144396197|EQUIVALENCE|Regression model that adjusts for the infant's sex and maternal height and weight at randomization.|Median Difference (Final Values)|-113.0||||0.005|TWO_SIDED|95.0|-201.0|-24.0|||Regression, Linear|P value was derived from a statistical model that adjusts for the infant's sex and maternal height and weight at randomization.||||-24|-201|0.005
72441349|NCT02980276|144396198|EQUIVALENCE|Two-sided test comparing observed mean difference to zero.|Mean Difference (Final Values)|0.0||||0.82|TWO_SIDED|95.0|-0.3|0.3|||t-test, 2 sided|||||0.3|-0.3|0.82
72441350|NCT02980276|144396199|EQUIVALENCE|Two-sided test comparing observed mean difference to zero.|Mean Difference (Final Values)|-0.7||||0.02|TWO_SIDED|95.0|-1.3|-0.2|||t-test, 2 sided|||||-0.2|-1.3|0.02
72441351|NCT02980276|144396200|EQUIVALENCE|Two-sided test comparing observed mean difference to zero.|Mean Difference (Final Values)|0.1||||0.72|TWO_SIDED|95.0|-0.5|0.7|||t-test, 2 sided|||||0.7|-0.5|0.72
72441352|NCT02980276|144396201|EQUIVALENCE|Two-sided test comparing observed mean difference to zero.|Mean Difference (Final Values)|0.0||||0.68|TWO_SIDED|95.0|-0.1|0.1|||t-test, 2 sided|||||0.1|-0.1|0.68
72441353|NCT02980276|144396202|EQUIVALENCE|Two-sided test comparing observed risk difference to zero.|Risk Difference (RD)|-7.2||||0.02|TWO_SIDED|95.0|-12.6|-1.8|||Regression, Logistic|P value derived from a statistical model that adjusts for the infant's sex, gestational age at birth, and maternal height and weight at randomization.|P value derived from a statistical model that adjusts for the infant's sex, gestational age at birth, and maternal height and weight at randomization.|||-1.8|-12.6|0.02
72441354|NCT02980276|144396203|EQUIVALENCE|Two-sided test comparing observed risk difference to zero.|Risk Difference (RD)|-8.4||||0.003|TWO_SIDED|95.0|-13.7|-3.2|||Risk difference|P value derived from a statistical model that adjusts for the infant's sex and maternal height and weight at randomization|Units are %|||-3.2|-13.7|0.003
72441355|NCT02980276|144396204|EQUIVALENCE|Two-sided test comparing observed risk difference to zero.|Risk Difference (RD)|2.7||||0.012|TWO_SIDED|95.0|-1.0|6.3|||Risk difference|Units are %. P value derived from model adjusting for the gestational age at birth, sex and maternal height and weight at randomization.|Units are %. P value was derived from a statistical model that adjusts for the infant's gestational age at birth, sex and maternal height and weight at randomization.|||6.3|-1|.012
72441356|NCT02980276|144396205|EQUIVALENCE|Two-sided test comparing observed risk difference to zero.|Risk Difference (RD)|3.0||||0.13|TWO_SIDED|95.0|-0.4|6.5||Units are %. P value was derived from a statistical model that adjusts for the infant's gestational age at birth, sex and maternal height and weight at randomization.|Regression, Logistic||Units are %. P value was derived from a statistical model that adjusts for the infant's gestational age at birth, sex and maternal height and weight at randomization.|||6.5|-0.4|0.13
72496143|NCT00927368|144522120|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority analysis used the 0.5-point noninferiority delta in a 1-tailed test of the treatment effect regression parameter (i.e., testing the null hypothesis that mean stimulating needle minus mean ultrasound alone is greater than 0.5 points).|Mean Difference (Final Values)|-2.0||||0.006|TWO_SIDED|95.0|-22.0|25.0||Significance criterion of 0.01041 after adjusting for group sequential design and applying Holm Bonferroni procedure to account for multiple comparisons.|t-test, 2 sided|||The primary analysis for opioid was a linear regression model comparing stimulating needle to ultrasound alone on the log of cumulative opioid consumption score for a patient in the first 48 hours.||25|-22|0.006
72496144|NCT00927368|144522120|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority analysis used the 0.5-point noninferiority delta in a 1-tailed test of the treatment effect regression parameter (i.e., testing the null hypothesis that mean ultrasound alone minus mean stimulating needle is greater than 0.5 points).|Mean Difference (Final Values)|2.0||||0.02|TWO_SIDED|95.0|-20.0|29.0||Significance criterion of 0.01388 after adjusting for group sequential design and applying Holm Bonferroni procedure to account for multiple comparisons.|t-test, 2 sided|||The primary analysis for opioid was a linear regression model comparing ultrasound alone to stimulating needle on the log of cumulative opioid consumption score for a patient in the first 48 hours.||29|-20|0.02
72496145|NCT00927368|144522121|SUPERIORITY_OR_OTHER|||||||0.11|||||||ANOVA|||Stimulating needle versus stimulating catheter.||||0.11
72496146|NCT00927368|144522121|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|40.0||||0.01|TWO_SIDED|95.0|6.0|75.0|||ANOVA|||Stimulating needle versus ultrasound guidance alone||75|6|0.01
72496147|NCT00927368|144522121|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|67.0|||<|0.001|TWO_SIDED|95.0|31.0|102.0|||ANOVA|||Stimulating catheter versus ultrasound guidance alone||102|31|< 0.001
72496148|NCT00927368|144522122|SUPERIORITY_OR_OTHER||incremental cost, measured in dollars|14.0|||||TWO_SIDED||||||||Incremental cost (additional cost of stimulating needle compared to ultrasound alone).|We calculated incremental cost, defined as the additional cost of one strategy to the next less costly strategy.||||
72619038|NCT00563316|144768688|NON_INFERIORITY_OR_EQUIVALENCE|It would be concluded that panitumumab did not have a clinically important effect on the pharmacokinetics of irinotecan if the 90% confidence intervals of the ratio of geometric means for the Cmax and AUC values for irinotecan with and without concomitant panitumumab administration fell within the interval of 70% to 143%.|Least Squares Geometric Mean Ratio|0.98|||||TWO_SIDED|90.0|0.894|1.074|||||Ratio of Cycle 2 : Cycle 1|||1.074|0.894|
72619039|NCT00563316|144768689|NON_INFERIORITY_OR_EQUIVALENCE|It would be concluded that panitumumab did not have a clinically important effect on the pharmacokinetics of irinotecan if the 90% confidence intervals of the ratio of geometric means for the Cmax and AUC values for irinotecan with and without concomitant panitumumab administration fell within the interval of 70% to 143%.|Least Squares Geometric Mean Ratio|0.898|||||TWO_SIDED|90.0|0.819|0.985|||||Ratio of Cycle 2 : Cycle 1|||0.985|0.819|
72441357|NCT02980276|144396206|EQUIVALENCE|Two-sided test comparing observed risk difference to zero.|Risk Difference (RD)|3.0||||0.38|TWO_SIDED|95.0|-2.9|9.0|||Risk difference||Units are %.|||9|-2.9|0.38
72441358|NCT02980276|144396207|EQUIVALENCE|Two-sided test comparing observed risk difference to zero.|Risk Difference (RD)|2.8||||0.33|TWO_SIDED|95.0|-2.0|7.3|||Risk difference||Units are %|||7.3|-2.0|0.33
72441359|NCT02980276|144396208|EQUIVALENCE|Two-sided test comparing observed risk difference to zero.|Risk Difference (RD)|2.3||||0.42|TWO_SIDED|95.0|-2.4|6.9|||Risk difference||Units are %|||6.9|-2.4|0.42
72496149|NCT00927368|144522122|SUPERIORITY_OR_OTHER||incremental cost, measured in dollars|36.0|||||TWO_SIDED||||||||We estimated incremental cost, or additional cost of stimulating needle + catheter stimulation to stimulating needle alone.|We calculated incremental cost, defined as the additional cost of one strategy to the next less costly strategy.||||
72496150|NCT00927368|144522122|SUPERIORITY_OR_OTHER||incremental cost, measured in dollars|50.0|||||TWO_SIDED||||||||We calculated incremental cost, or the additional cost of stimulating needle + stimulating catheter to ultrasound alone.|We calculated incremental cost, defined as the additional cost of one strategy to the next less costly strategy.||||
72496151|NCT04276207|144522152|SUPERIORITY||Mean Difference (Final Values)|-0.377||||0.145|TWO_SIDED|95.0|-0.896|0.142|||Mixed Models Analysis|||||0.142|-0.896|0.1450
72441360|NCT02980276|144396209|EQUIVALENCE|Two-sided test comparing observed risk difference to zero.|Risk Difference (RD)|0.4|||>|0.99|TWO_SIDED|95.0|-0.4|1.1|||Risk difference||Units are %.|||1.1|-0.4|>0.99
72441361|NCT02980276|144396210|EQUIVALENCE|Two-sided test comparing observed risk difference to zero.|Risk Difference (RD)|1.1||||0.62|TWO_SIDED|95.0|-1.9|4.2|||Risk difference||Units are %|||4.2|-1.9|0.62
72619040|NCT00563316|144768690|NON_INFERIORITY_OR_EQUIVALENCE|It would be concluded that panitumumab did not have a clinically important effect on the pharmacokinetics of irinotecan if the 90% confidence intervals of the ratio of geometric means for the Cmax and AUC values for irinotecan with and without concomitant panitumumab administration fell within the interval of 70% to 143%.|Least Squares Geometric Mean Ratio|0.897|||||TWO_SIDED|90.0|0.818|0.983|||||Ratio of Cycle 2 : Cycle 1|||0.983|0.818|
72441362|NCT02980276|144396211|EQUIVALENCE|Two-sided test comparing observed risk difference to zero.|Risk Difference (RD)|0.0|||>|0.99|TWO_SIDED|95.0|-1.0|1.0|||Risk difference||Units are %|||1|-1|>0.99
72441363|NCT02980276|144396212|EQUIVALENCE|Two-sided test comparing observed risk difference to zero.|Risk Difference (RD)|0.7||||0.9|TWO_SIDED|95.0|-5.1|6.6|||Risk difference||Units are %|||6.6|-5.1|0.9
72441364|NCT01443845|144396258|SUPERIORITY_OR_OTHER||Rate Ratio|0.92|STANDARD_ERROR_OF_MEAN|0.063||0.1634|TWO_SIDED|95.0|0.81|1.04|||negative binomial regression||p-values are based on a negative binomial regression with factors Treatment and LAMA use.|Rate ratio (Roflumilast/Placebo). A rate ratio \< 1 represents a favorable outcome for the test treatment.||1.04|0.81|0.1634
72441365|NCT01443845|144396258|SUPERIORITY_OR_OTHER||Rate Ratio|0.83|STANDARD_ERROR_OF_MEAN|0.08||0.0195|TWO_SIDED|95.0|0.71|0.97|||negative binomial regression|||Subgroup Analysis - By Sex - Male||0.97|0.71|0.0195
72441366|NCT01443845|144396258|SUPERIORITY_OR_OTHER||Rate Ratio|1.11|STANDARD_ERROR_OF_MEAN|0.101||0.3164|TWO_SIDED|95.0|0.91|1.35|||negative binomial regression|||Subgroup Analysis - By Sex - Female||1.35|0.91|0.3164
72441367|NCT01443845|144396258|SUPERIORITY_OR_OTHER||Rate Ratio|0.85|STANDARD_ERROR_OF_MEAN|0.076||0.0385|TWO_SIDED|95.0|0.74|0.99|||negative binomial regression|||Subgroup analysis between patients taking Advair verses patients taking Symbicort as LABA/ICS therapy.||0.99|0.74|0.0385
72441368|NCT01443845|144396258|SUPERIORITY_OR_OTHER||Rate Ratio|1.05|STANDARD_ERROR_OF_MEAN|0.114||0.6475|TWO_SIDED|95.0|0.84|1.32|||negative binomial regression|||Subgroup analysis between patients taking Advair verses patients taking Symbicort as LABA/ICS therapy.||1.32|0.84|0.6475
72441369|NCT01443845|144396259|SUPERIORITY_OR_OTHER||Rate Ratio|0.95|STANDARD_ERROR_OF_MEAN|0.118||0.6354|TWO_SIDED|95.0|0.75|1.19|||negative binomial regression|||||1.19|0.75|0.6354
72496152|NCT04276207|144522153|SUPERIORITY||Mean Difference (Final Values)|-0.262||||0.001|TWO_SIDED|95.0|-0.406|-0.117|||Mixed Models Analysis|||||-0.117|-0.406|0.0010
72619041|NCT04595370|144768699|OTHER||F test statistics|1.07||||0.3645|||||||F-Test|||||||0.3645
72441370|NCT01443845|144396260|SUPERIORITY_OR_OTHER||Rate Ratio|0.9|STANDARD_ERROR_OF_MEAN|0.06||0.0884|TWO_SIDED|95.0|0.8|1.02|||negative binomial regression|||||1.02|0.8|0.0884
72441371|NCT01443845|144396261|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0532|STANDARD_ERROR_OF_MEAN|0.0067|<|0.0001|TWO_SIDED|95.0|0.04|0.0664||The MMRM analysis is based on all postbaseline observed data using a mixed model with terms for treatment, baseline, visit, LAMA use, treatment-by-visit and baseline-by-visit interactions.|Mixed Model for Repeated Measures (MMRM)|||||0.0664|0.04|< 0.0001
72441372|NCT00520546|144396262|SUPERIORITY_OR_OTHER||sensitivity|97.0||||0.0526|TWO_SIDED|95.0|86.0|100.0|||Fisher Exact|||"results from FEC-PET as compared with histological results on a patient based analysis~Null hypothesis: patient distribution in contingency table is incidental."||100|86|0.0526
72441373|NCT00520546|144396262|SUPERIORITY_OR_OTHER||specificity|0.0||||0.0526|TWO_SIDED|95.0|0.0|98.0|||Fisher Exact|||"results from FEC-PET as compared with histological results on a patient based analysis~Null hypothesis: patient distribution in contingency table is incidental."||98|0|0.0526
72441374|NCT00520546|144396262|SUPERIORITY_OR_OTHER||accuracy|95.0||||0.0526|TWO_SIDED|95.0|82.0|99.0|||Fisher Exact|||"results from FEC-PET as compared with histological results on a patient based analysis~Null hypothesis: patient distribution in contingency table is incidental."||99|82|0.0526
72441375|NCT00520546|144396262|SUPERIORITY_OR_OTHER||sensitivity|70.0|||<|0.0001|TWO_SIDED|95.0|53.0|84.0|||Fisher Exact|||"results from MRI as compared with histological results on a patient based analysis~Null hypothesis: patient distribution in contingency table is incidental."||84|53|<0.0001
72496153|NCT04276207|144522154|SUPERIORITY||Mean Difference (Final Values)|-12.61||||0.0173|TWO_SIDED|95.0|-22.73|-2.49|||Mixed Models Analysis|||Day 1||-2.49|-22.73|0.0173
72496154|NCT04276207|144522154|SUPERIORITY||Mean Difference (Final Values)|-5.75||||0.0243|TWO_SIDED|95.0|-10.69|0.81|||Mixed Models Analysis|||Day 2||0.81|-10.69|0.0243
72619042|NCT04595370|144768700|OTHER||Percent difference between treatment|-33.606||||0.1588|TWO_SIDED|95.0|-62.53|17.644|||Mixed Models Analysis|||||17.644|-62.530|0.1588
72441376|NCT00520546|144396262|SUPERIORITY_OR_OTHER||specificity|0.0|||<|0.0001|TWO_SIDED|95.0|0.0|98.0|||Fisher Exact|||"results from MRI as compared with histological results on a patient based analysis~Null hypothesis: patient distribution in contingency table is incidental."||98|0|<0.0001
72441377|NCT00520546|144396262|SUPERIORITY_OR_OTHER||accuracy|68.0|||<|0.0001|TWO_SIDED|95.0|51.0|83.0|||Fisher Exact|||"results from MRI as compared with histological results on a patient based analysis~Null hypothesis: patient distribution in contingency table is incidental."||83|51|<0.0001
72441378|NCT00520546|144396262|SUPERIORITY_OR_OTHER||sensitivity|95.0||||0.0043|TWO_SIDED|95.0|82.0|99.0|||Fisher Exact|||"results from PET/MRI as compared with histological results on a patient based analysis~Null hypothesis: patient distribution in contingency table is incidental."||99|82|0.0043
72441379|NCT00520546|144396262|SUPERIORITY_OR_OTHER||specificity|100.0||||0.0043|TWO_SIDED|95.0|3.0|100.0|||Fisher Exact|||"results from PET/MRI as compared with histological results on a patient based analysis~Null hypothesis: patient distribution in contingency table is incidental."||100|3|0.0043
72441380|NCT00520546|144396262|SUPERIORITY_OR_OTHER||accuracy|95.0||||0.0043|TWO_SIDED|95.0|82.0|99.0|||Fisher Exact|||"results from PET/MRI as compared with histological results on a patient based analysis~Null hypothesis: patient distribution in contingency table is incidental."||99|82|0.0043
72441381|NCT00520546|144396263|SUPERIORITY_OR_OTHER||positive prediction|69.0||||0.09||95.0|||||Fisher Exact|||"lesion based (all lesions = 128) results from FEC-PET as compared with histological results on a lesion based analysis of all patients (38)~Null hypothesis: patient distribution in contingency table is incidental."||||0.09
72441382|NCT00520546|144396263|SUPERIORITY_OR_OTHER||negative prediction|44.0||||0.09||95.0|||||Fisher Exact|||"lesion based (all lesions = 128) results from FEC-PET as compared with histological results on a lesion based analysis of all patients (38)~Null hypothesis: patient distribution in contingency table is incidental."||||0.09
72496155|NCT04276207|144522155|SUPERIORITY|||||||0.945|||||||Mixed Models Analysis|||Day 1||||0.945
72441383|NCT00520546|144396263|SUPERIORITY_OR_OTHER||sensitivity|71.0||||0.09||95.0|||||Fisher Exact|||"lesion based (all lesions = 128) results from FEC-PET as compared with histological results on a lesion based analysis of all patients (38)~Null hypothesis: patient distribution in contingency table is incidental."||||0.09
72496156|NCT04276207|144522155|SUPERIORITY|||||||0.888|||||||Mixed Models Analysis|||Day 2||||0.888
72496157|NCT05099640|144522210|OTHER||LS Mean Difference|-395.87|STANDARD_ERROR_OF_MEAN|33.848|<|0.0001|TWO_SIDED|95.0|-463.07|-328.66|||Mixed Models Analysis|||||-328.66|-463.07|<0.0001
72496158|NCT05099640|144522211|OTHER||LS Mean Difference|-64.22|STANDARD_ERROR_OF_MEAN|4.973|<|0.0001|TWO_SIDED|95.0|-74.09|-54.35|||Mixed Models Analysis|||||-54.35|-74.09|<0.0001
72496159|NCT05099640|144522212|OTHER||Odds Ratio (OR)|30.33|||<|0.0001|TWO_SIDED|95.0|5.3|294.24|||Chi-squared|||||294.24|5.30|<0.0001
72496160|NCT05099640|144522213|OTHER||Odds Ratio (OR)|51.54|||<|0.0001|TWO_SIDED|95.0|12.28|245.34|||Chi-squared|||||245.34|12.28|<0.0001
72496161|NCT05099640|144522214|OTHER||LS Mean Difference|-289.89|STANDARD_ERROR_OF_MEAN|33.44|<|0.0001|TWO_SIDED|95.0|-356.29|-223.5|||Mixed Models Analysis|||Weeks 1 and 2: Sepiapterin vs. Placebo||-223.50|-356.29|<0.0001
72496162|NCT05099640|144522214|OTHER||LS Mean Difference|-375.47|STANDARD_ERROR_OF_MEAN|30.424|<|0.0001|TWO_SIDED|95.0|-435.88|-315.06|||Mixed Models Analysis|||Weeks 3 and 4: Sepiapterin vs. Placebo||-315.06|-435.88|<0.0001
72496163|NCT05099640|144522214|OTHER||LS Mean Difference|-395.87|STANDARD_ERROR_OF_MEAN|33.848|<|0.0001|TWO_SIDED|95.0|-463.07|-328.66|||Mixed Models Analysis|||Weeks 5 and 6: Sepiapterin vs. Placebo||-328.66|-463.07|<0.0001
72496164|NCT05099640|144522215|OTHER||LS Mean Difference|-42.52|STANDARD_ERROR_OF_MEAN|6.008|<|0.0001|TWO_SIDED|95.0|-54.45|-30.59|||Mixed Models Analysis|||Weeks 1 and 2: Sepiapterin vs. Placebo||-30.59|-54.45|<0.0001
72496165|NCT05099640|144522215|OTHER||LS Mean Difference|-61.03|STANDARD_ERROR_OF_MEAN|4.531|<|0.0001|TWO_SIDED|95.0|-70.02|-52.03|||Mixed Models Analysis|||Weeks 3 and 4: Sepiapterin vs. Placebo||-52.03|-70.02|<0.0001
72441384|NCT00520546|144396263|SUPERIORITY_OR_OTHER||specificity|42.0||||0.09||95.0|||||Fisher Exact|||"lesion based (all lesions = 128) results from FEC-PET as compared with histological results on a lesion based analysis of all patients (38)~Null hypothesis: patient distribution in contingency table is incidental."||||0.09
72496166|NCT05099640|144522215|OTHER||LS Mean Difference|-64.22|STANDARD_ERROR_OF_MEAN|4.973|<|0.0001|TWO_SIDED|95.0|-74.09|-54.35|||Mixed Models Analysis|||Weeks 5 and 6: Sepiapterin vs. Placebo||-54.35|-74.09|<0.0001
72619043|NCT04595370|144768700|OTHER||Percent difference between treatment|-11.826||||0.6846|TWO_SIDED|95.0|-52.195|62.634|||Mixed Models Analysis|||||62.634|-52.195|0.6846
72496167|NCT05099640|144522220|OTHER||LS Mean Difference|-492.23|STANDARD_ERROR_OF_MEAN|55.588|<|0.0001|TWO_SIDED|95.0|-614.59|-369.87|||Mixed Models Analysis|||||-369.87|-614.59|<0.0001
72496168|NCT05099640|144522221|OTHER||LS Mean Difference|-74.73|STANDARD_ERROR_OF_MEAN|10.436|<|0.0001|TWO_SIDED|95.0|-97.72|-51.74|||Mixed Models Analysis|||||-51.74|-97.72|<0.0001
72496169|NCT01557166|144522230|SUPERIORITY_OR_OTHER||Estimated treatment difference|-6.1||||0.015||95.0|-11.0|-1.19|||ANCOVA|ANCOVA model was used with treatment, country and sex as fixed factors, and the baseline value of AHI, baseline BMI and baseline age as covariates.||Let μ liraglutide 3.0mg and μ placebo denote mean change in AHI for liraglutide 3.0 mg and placebo,respectively. The null-hypothesis and the alternative was H0: μliraglutide 3.0mg = μplacebo against the alternative HA: μliraglutide 3.0mg ≠ μplacebo.||-1.19|-11.0|0.015
72496170|NCT01469000|144522266|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.67||||0.009|TWO_SIDED|95.0|0.48|0.93||1-sided.|Regression, Cox|Adjusted for gender, performance status, previous adjuvant /neoadjuvant treatment, age, smoking history, mutation type, and country.||||0.93|0.48|0.009
72496171|NCT01469000|144522267|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.64||||0.005|TWO_SIDED|95.0|0.46|0.9||1 sided.|Regression, Cox|Adjusted for gender, performance status, previous adjuvant /neoadjuvant treatment, age, smoking history, mutation type, and country.||||0.90|0.46|0.005
72496172|NCT01469000|144522268|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.77||||0.105|TWO_SIDED|95.0|0.51|1.16||1 sided.|Regression, Cox|Adjusted for gender, performance status, previous adjuvant /neoadjuvant treatment, age, smoking history, mutation type, and country.||||1.16|0.51|0.105
72496173|NCT01469000|144522272|SUPERIORITY||Hazard Ratio (HR)|1.17|||||TWO_SIDED|95.0|0.77|1.78||||||Patient-rated Loss of Appetite: Time to worsening of symptom (TWS) was measured from the date of randomization to the first date of a 15-millimeter(mm) worsening from baseline on a scale of 0 (no symptoms) to 100 (as much as it could be).||1.78|0.77|
72496174|NCT01469000|144522272|SUPERIORITY||Hazard Ratio (HR)|0.92|||||TWO_SIDED|95.0|0.6|1.42||||||Patient-rated Fatigue: Time to worsening of symptom (TWS) was measured from the date of randomization to the first date of a 15-millimeter(mm) worsening from baseline on a scale of 0 (no symptoms) to 100 (as much as it could be).||1.42|0.60|
72496175|NCT01469000|144522272|SUPERIORITY||Hazard Ratio (HR)|1.39|||||TWO_SIDED|95.0|0.84|2.3||||||Patient-rated Cough: Time to worsening of symptom (TWS) was measured from the date of randomization to the first date of a 15-millimeter(mm) worsening from baseline on a scale of 0 (no symptoms) to 100 (as much as it could be).||2.30|0.84|
72496176|NCT01469000|144522272|SUPERIORITY||Hazard Ratio (HR)|1.06|||||TWO_SIDED|95.0|0.65|1.71||||||Patient-rated Dyspnea: Time to worsening of symptom (TWS) was measured from the date of randomization to the first date of a 15-millimeter(mm) worsening from baseline on a scale of 0 (no symptoms) to 100 (as much as it could be).||1.71|0.65|
72496177|NCT01469000|144522272|SUPERIORITY||Hazard Ratio (HR)|0.57|||||TWO_SIDED|95.0|0.32|1.02||||||Patient-rated Hemoptysis: Time to worsening of symptom (TWS) was measured from the date of randomization to the first date of a 15-millimeter(mm) worsening from baseline on a scale of 0 (no symptoms) to 100 (as much as it could be).||1.02|0.32|
72619044|NCT04595370|144768700|OTHER||Percent difference between treatment|-36.127||||0.1398|TWO_SIDED|95.0|-64.85|16.066|||Mixed Models Analysis|||||16.066|-64.850|0.1398
72441385|NCT00520546|144396263|SUPERIORITY_OR_OTHER||accuracy|61.0||||0.09||95.0|||||Fisher Exact|||"lesion based (all lesions = 128) results from FEC-PET as compared with histological results on a lesion based analysis of all patients (38)~Null hypothesis: patient distribution in contingency table is incidental."||||0.09
72441386|NCT00520546|144396263|SUPERIORITY_OR_OTHER||positive prediction|60.0||||0.27||95.0|||||Fisher Exact|||"lesion based (all lesions = 128) results from MRI as compared with histological results on a lesion based analysis of all patients (38)~Null hypothesis: patient distribution in contingency table is incidental."||||0.27
72441387|NCT00520546|144396263|SUPERIORITY_OR_OTHER||negative prediction|30.0||||0.27||95.0|||||Fisher Exact|||"lesion based (all lesions = 128) results from MRI as compared with histological results on a lesion based analysis of all patients (38)~Null hypothesis: patient distribution in contingency table is incidental."||||0.27
72441388|NCT00520546|144396263|SUPERIORITY_OR_OTHER||sensitivity|48.0||||0.27||95.0|||||Fisher Exact|||"lesion based (all lesions = 128) results from MRI as compared with histological results on a lesion based analysis of all patients (38)~Null hypothesis: patient distribution in contingency table is incidental."||||0.27
72441389|NCT00520546|144396263|SUPERIORITY_OR_OTHER||specificity|40.0||||0.27||95.0|||||Fisher Exact|||"lesion based (all lesions = 128) results from MRI as compared with histological results on a lesion based analysis of all patients (38)~Null hypothesis: patient distribution in contingency table is incidental."||||0.27
72441390|NCT00520546|144396263|SUPERIORITY_OR_OTHER||accuracy|45.0||||0.27||95.0|||||Fisher Exact|||"lesion based (all lesions = 128) results from MRI as compared with histological results on a lesion based analysis of all patients (38)~Null hypothesis: patient distribution in contingency table is incidental."||||0.27
72441391|NCT00520546|144396263|SUPERIORITY_OR_OTHER||positive prediction|87.0|||<|0.001||95.0|||||Fisher Exact|||"lesion based (all lesions = 128) results from PET/MRI as compared with histological results on a lesion based analysis of all patients (38)~Null hypothesis: patient distribution in contingency table is incidental."||||<0.001
72441392|NCT00520546|144396263|SUPERIORITY_OR_OTHER||negative prediction|57.0|||<|0.001||95.0|||||Fisher Exact|||"lesion based (all lesions = 128) results from PET/MRI as compared with histological results on a lesion based analysis of all patients (38)~Null hypothesis: patient distribution in contingency table is incidental."||||<0.001
72496178|NCT01469000|144522272|SUPERIORITY||Hazard Ratio (HR)|1.11|||||TWO_SIDED|95.0|0.64|1.91||||||Patient-rated Pain: Time to worsening of symptom (TWS) was measured from the date of randomization to the first date of a 15-millimeter(mm) worsening from baseline on a scale of 0 (no symptoms) to 100 (as much as it could be).||1.91|0.64|
72496179|NCT01469000|144522272|SUPERIORITY||Hazard Ratio (HR)|1.1|||||TWO_SIDED|95.0|0.68|1.77||||||Patient-rated Overall Symptoms: Time to worsening of symptom (TWS) was measured from the date of randomization to the first date of a 15-millimeter(mm) worsening from baseline on a scale of 0 (no symptoms) to 100 (as much as it could be).||1.77|0.68|
72559260|NCT02426918|144648160|NON_INFERIORITY|Non-inferiority for the low dose was confirmed if the upper bound of the CI was \< 15% and if non-inferiority was confirmed for the high dose.|Risk Difference (RD)|-4.2|||||TWO_SIDED|95.0|-11.42|3.0||||||Treatment difference estimates and 95% CIs are calculated accounting for the randomization strata infection type \[cellulitis, noncellulitis\] according to a Mantel-Haenszel type risk difference estimator.||3.00|-11.42|
72496180|NCT01469000|144522272|SUPERIORITY||Hazard Ratio (HR)|1.38|||||TWO_SIDED|95.0|0.88|2.17||||||Patient-rated Interference: Time to worsening of symptom (TWS) was measured from the date of randomization to the first date of a 15-millimeter(mm) worsening from baseline on a scale of 0 (no symptoms) to 100 (as much as it could be).||2.17|0.88|
72496181|NCT01469000|144522272|SUPERIORITY||Hazard Ratio (HR)|1.12|||||TWO_SIDED|95.0|0.72|1.74||||||Patient-rated Quality of Life: Time to worsening of symptom (TWS) was measured from the date of randomization to the first date of a 15-millimeter(mm) worsening from baseline on a scale of 0 (no symptoms) to 100 (as much as it could be).||1.74|0.72|
72496182|NCT01469000|144522272|SUPERIORITY||Hazard Ratio (HR)|1.56|||||TWO_SIDED|95.0|0.97|2.49||||||Observer-rated Loss of Appetite: Time to worsening of symptom (TWS) was measured from the date of randomization to the first date of a 15-millimeter(mm) worsening from baseline on a scale of 0 (Severe) to 100 (None). This scoring system is the reverse of the patient scale. The observer scale is a categorical 5-point scale and specific descriptors are provided with each questions for each of the scores (0,25,50,75 and 100)||2.49|0.97|
72559261|NCT02426918|144648160|NON_INFERIORITY|Non-inferiority for the high dose was confirmed if the upper bound of the CI was \< 15%.|Risk Difference (RD)|0.0|||||TWO_SIDED|95.0|-8.32|8.38||||||Treatment difference estimates and 95% CIs are calculated accounting for the randomization strata infection type \[cellulitis, noncellulitis\] according to a Mantel-Haenszel type risk difference estimator.||8.38|-8.32|
72441393|NCT00520546|144396263|SUPERIORITY_OR_OTHER||sensitivity|66.0|||<|0.001||95.0|||||Fisher Exact|||"lesion based (all lesions = 128) results from PET/MRI as compared with histological results on a lesion based analysis of all patients (38)~Null hypothesis: patient distribution in contingency table is incidental."||||<0.001
72441394|NCT00520546|144396263|SUPERIORITY_OR_OTHER||specificity|82.0|||<|0.001||95.0|||||Fisher Exact|||"lesion based (all lesions = 128) results from PET/MRI as compared with histological results on a lesion based analysis of all patients (38)~Null hypothesis: patient distribution in contingency table is incidental."||||<0.001
72441395|NCT00520546|144396263|SUPERIORITY_OR_OTHER||accuracy|72.0|||<|0.001||95.0|||||Fisher Exact|||"lesion based (all lesions = 128) results from PET/MRI as compared with histological results on a lesion based analysis of all patients (38)~Null hypothesis: patient distribution in contingency table is incidental."||||<0.001
72441396|NCT00520546|144396264|SUPERIORITY_OR_OTHER||positive prediction|84.0|||<|0.001||95.0|||||Fisher Exact|||"Lesion based analysis of FEC-PET, endorectal MRI and combined FEC-PET/eMRI in patients with Gleason Score \>6 (n=43) as compared with histological results on a lesion based analysis of all patients (38)~Null hypothesis: patient distribution in contingency table is incidental."||||<0.001
72559262|NCT02420353|144648200|OTHER|||||||0.0498|||||||Mixed Models Analysis|||Mixed effect model||||0.0498
72441397|NCT00520546|144396264|SUPERIORITY_OR_OTHER||negative prediction|73.0|||<|0.001||95.0|||||Fisher Exact|||"Lesion based analysis of FEC-PET, endorectal MRI and combined FEC-PET/eMRI in patients with Gleason Score \>6 (n=43) as compared with histological results on a lesion based analysis of all patients (n=38)~Null hypothesis: patient distribution in contingency table is incidental."||||<0.001
72441398|NCT00520546|144396264|SUPERIORITY_OR_OTHER||sensitivity|90.0|||<|0.001||95.0|||||Fisher Exact|||"Lesion based analysis of FEC-PET, endorectal MRI and combined FEC-PET/eMRI in patients with Gleason Score \>6 (n=43) as compared with histological results on a lesion based analysis of all patients (n=38)~Null hypothesis: patient distribution in contingency table is incidental."||||<0.001
72441399|NCT00520546|144396264|SUPERIORITY_OR_OTHER||specificity|84.0|||<|0.001||95.0|||||Fisher Exact|||"Lesion based analysis of FEC-PET, endorectal MRI and combined FEC-PET/eMRI in patients with Gleason Score \>6 (n=43) as compared with histological results on a lesion based analysis of all patients (n=38)~Null hypothesis: patient distribution in contingency table is incidental."||||<0.001
72441400|NCT00520546|144396264|SUPERIORITY_OR_OTHER||accuracy|82.0|||<|0.001||95.0|||||Fisher Exact|||"Lesion based analysis of FEC-PET, endorectal MRI and combined FEC-PET/eMRI in patients with Gleason Score \>6 (n=43) as compared with histological results on a lesion based analysis of all patients (n=38)~Null hypothesis: patient distribution in contingency table is incidental."||||<0.001
72441401|NCT00520546|144396264|SUPERIORITY_OR_OTHER||positive prediction|71.0||||0.53||95.0|||||Fisher Exact|||"Lesion based analysis of FEC-PET, endorectal MRI and combined FEC-PET/eMRI in patients with Gleason Score \>6 (n=43) as compared with histological results on a lesion based analysis of all patients (n=38)~Null hypothesis: patient distribution in contingency table is incidental."||||0.53
72441402|NCT00520546|144396264|SUPERIORITY_OR_OTHER||negative prediction|33.0||||0.53||95.0|||||Fisher Exact|||"Lesion based analysis of FEC-PET, endorectal MRI and combined FEC-PET/eMRI in patients with Gleason Score \>6 (n=43) as compared with histological results on a lesion based analysis of all patients (n=38)~Null hypothesis: patient distribution in contingency table is incidental."||||0.53
72441403|NCT00520546|144396264|SUPERIORITY_OR_OTHER||sensitivity|73.0||||0.53||95.0|||||Fisher Exact|||"Lesion based analysis of FEC-PET, endorectal MRI and combined FEC-PET/eMRI in patients with Gleason Score \>6 (n=43) as compared with histological results on a lesion based analysis of all patients (n=38)~Null hypothesis: patient distribution in contingency table is incidental."||||0.53
72441404|NCT00520546|144396264|SUPERIORITY_OR_OTHER||specificity|31.0||||0.53||95.0|||||Fisher Exact|||"Lesion based analysis of FEC-PET, endorectal MRI and combined FEC-PET/eMRI in patients with Gleason Score \>6 (n=43) as compared with histological results on a lesion based analysis of all patients (n=38)~Null hypothesis: patient distribution in contingency table is incidental."||||0.53
72441405|NCT00520546|144396264|SUPERIORITY_OR_OTHER||accuracy|60.0||||0.53||95.0|||||Fisher Exact|||"Lesion based analysis of FEC-PET, endorectal MRI and combined FEC-PET/eMRI in patients with Gleason Score \>6 (n=43) as compared with histological results on a lesion based analysis of all patients (n=38)~Null hypothesis: patient distribution in contingency table is incidental."||||0.53
72441406|NCT00520546|144396264|SUPERIORITY_OR_OTHER||positive prediction|96.0|||<|0.001||95.0|||||Fisher Exact|||"Lesion based analysis of FEC-PET, endorectal MRI and combined FEC-PET/eMRI in patients with Gleason Score \>6 (n=43) as compared with histological results on a lesion based analysis of all patients (n=38)~Null hypothesis: patient distribution in contingency table is incidental."||||<0.001
72441407|NCT00520546|144396264|SUPERIORITY_OR_OTHER||negative prediction|73.0|||<|0.001||95.0|||||Fisher Exact|||"Lesion based analysis of FEC-PET, endorectal MRI and combined FEC-PET/eMRI in patients with Gleason Score \>6 (n=43) as compared with histological results on a lesion based analysis of all patients (n=38)~Null hypothesis: patient distribution in contingency table is incidental."||||<0.001
72441408|NCT00520546|144396264|SUPERIORITY_OR_OTHER||sensitivity|87.0|||<|0.001||95.0|||||Fisher Exact|||"Lesion based analysis of FEC-PET, endorectal MRI and combined FEC-PET/eMRI in patients with Gleason Score \>6 (n=43) as compared with histological results on a lesion based analysis of all patients (n=38)~Null hypothesis: patient distribution in contingency table is incidental."||||<0.001
72441409|NCT00520546|144396264|SUPERIORITY_OR_OTHER||specificity|92.0|||<|0.001||95.0|||||Fisher Exact|||"Lesion based analysis of FEC-PET, endorectal MRI and combined FEC-PET/eMRI in patients with Gleason Score \>6 (n=43) as compared with histological results on a lesion based analysis of all patients (n=38)~Null hypothesis: patient distribution in contingency table is incidental."||||<0.001
72441410|NCT00520546|144396264|SUPERIORITY_OR_OTHER||accuracy|88.0|||<|0.001||95.0|||||Fisher Exact|||"Lesion based analysis of FEC-PET, endorectal MRI and combined FEC-PET/eMRI in patients with Gleason Score \>6 (n=43) as compared with histological results on a lesion based analysis of all patients (n=38)~Null hypothesis: patient distribution in contingency table is incidental."||||<0.001
72441411|NCT00520546|144396265|SUPERIORITY_OR_OTHER||positive prediction|67.0||||0.002||95.0|||||Fisher Exact|||"Lesion based analysis of FEC-PET, endorectal MRI and combined FEC-PET/eMRI in patients with malign lesions \>5mm (n=98) as compared with histological results on a lesion based analysis of all patients (n=38)~Null hypothesis: patient distribution in contingency table is incidental."||||0.002
72441412|NCT00520546|144396265|SUPERIORITY_OR_OTHER||negative prediction|69.0||||0.002||95.0|||||Fisher Exact|||"Lesion based analysis of FEC-PET, endorectal MRI and combined FEC-PET/eMRI in patients with malign lesions \>5mm (n=98) as compared with histological results on a lesion based analysis of all patients (n=38)~Null hypothesis: patient distribution in contingency table is incidental."||||0.002
72441413|NCT00520546|144396265|SUPERIORITY_OR_OTHER||sensitivity|86.0||||0.002||95.0|||||Fisher Exact|||"Lesion based analysis of FEC-PET, endorectal MRI and combined FEC-PET/eMRI in patients with malign lesions \>5mm (n=98) as compared with histological results on a lesion based analysis of all patients (n=38)~Null hypothesis: patient distribution in contingency table is incidental."||||0.002
72441414|NCT00520546|144396265|SUPERIORITY_OR_OTHER||specificity|43.0||||0.002||95.0|||||Fisher Exact|||"Lesion based analysis of FEC-PET, endorectal MRI and combined FEC-PET/eMRI in patients with malign lesions \>5mm (n=98) as compared with histological results on a lesion based analysis of all patients (n=38)~Null hypothesis: patient distribution in contingency table is incidental."||||0.002
72441415|NCT00520546|144396265|SUPERIORITY_OR_OTHER||accuracy|67.0||||0.002||95.0|||||Fisher Exact|||"Lesion based analysis of FEC-PET, endorectal MRI and combined FEC-PET/eMRI in patients with malign lesions \>5mm (n=98) as compared with histological results on a lesion based analysis of all patients (n=38)~Null hypothesis: patient distribution in contingency table is incidental."||||0.002
72441416|NCT00520546|144396265|SUPERIORITY_OR_OTHER||positive prediction|59.0||||0.41||95.0|||||Fisher Exact|||"Lesion based analysis of FEC-PET, endorectal MRI and combined FEC-PET/eMRI in patients with malign lesions \>5mm (n=98) as compared with histological results on a lesion based analysis of all patients (n=38)~Null hypothesis: patient distribution in contingency table is incidental."||||0.41
72441417|NCT00520546|144396265|SUPERIORITY_OR_OTHER||negative prediction|46.0||||0.41||95.0|||||Fisher Exact|||"Lesion based analysis of FEC-PET, endorectal MRI and combined FEC-PET/eMRI in patients with malign lesions \>5mm (n=98) as compared with histological results on a lesion based analysis of all patients (n=38)~Null hypothesis: patient distribution in contingency table is incidental."||||0.41
72559263|NCT02420353|144648201|OTHER|Mixed effects model||||||0.7024|||||||Mixed Models Analysis|||||||0.7024
72441418|NCT00520546|144396265|SUPERIORITY_OR_OTHER||sensitivity|66.0||||0.41||95.0|||||Fisher Exact|||"Lesion based analysis of FEC-PET, endorectal MRI and combined FEC-PET/eMRI in patients with malign lesions \>5mm (n=98) as compared with histological results on a lesion based analysis of all patients (n=38)~Null hypothesis: patient distribution in contingency table is incidental."||||0.41
72441419|NCT00520546|144396265|SUPERIORITY_OR_OTHER||specificity|38.0||||0.41||95.0|||||Fisher Exact|||"Lesion based analysis of FEC-PET, endorectal MRI and combined FEC-PET/eMRI in patients with malign lesions \>5mm (n=98) as compared with histological results on a lesion based analysis of all patients (n=38)~Null hypothesis: patient distribution in contingency table is incidental."||||0.41
72441420|NCT00520546|144396265|SUPERIORITY_OR_OTHER||accuracy|54.0||||0.41||95.0|||||Fisher Exact|||"Lesion based analysis of FEC-PET, endorectal MRI and combined FEC-PET/eMRI in patients with malign lesions \>5mm (n=98) as compared with histological results on a lesion based analysis of all patients (n=38)~Null hypothesis: patient distribution in contingency table is incidental."||||0.41
72441421|NCT00520546|144396265|SUPERIORITY_OR_OTHER||positive prediction|86.0|||<|0.001||95.0|||||Fisher Exact|||"Lesion based analysis of FEC-PET, endorectal MRI and combined FEC-PET/eMRI in patients with malign lesions \>5mm (n=98) as compared with histological results on a lesion based analysis of all patients (n=38)~Null hypothesis: patient distribution in contingency table is incidental."||||<0.001
72441422|NCT00520546|144396265|SUPERIORITY_OR_OTHER||negative prediction|76.0|||<|0.001||95.0|||||Fisher Exact|||"Lesion based analysis of FEC-PET, endorectal MRI and combined FEC-PET/eMRI in patients with malign lesions \>5mm (n=98) as compared with histological results on a lesion based analysis of all patients (n=38)~Null hypothesis: patient distribution in contingency table is incidental."||||<0.001
72441423|NCT00520546|144396265|SUPERIORITY_OR_OTHER||sensitivity|83.0|||<|0.001||95.0|||||Fisher Exact|||"Lesion based analysis of FEC-PET, endorectal MRI and combined FEC-PET/eMRI in patients with malign lesions \>5mm (n=98) as compared with histological results on a lesion based analysis of all patients (n=38)~Null hypothesis: patient distribution in contingency table is incidental."||||<0.001
72441424|NCT00520546|144396265|SUPERIORITY_OR_OTHER||specificity|80.0|||<|0.001||95.0|||||Fisher Exact|||"Lesion based analysis of FEC-PET, endorectal MRI and combined FEC-PET/eMRI in patients with malign lesions \>5mm (n=98) as compared with histological results on a lesion based analysis of all patients (n=38)~Null hypothesis: patient distribution in contingency table is incidental."||||<0.001
72441425|NCT00520546|144396265|SUPERIORITY_OR_OTHER||accuracy|82.0|||<|0.001||95.0|||||Fisher Exact|||"Lesion based analysis of FEC-PET, endorectal MRI and combined FEC-PET/eMRI in patients with malign lesions \>5mm (n=98) as compared with histological results on a lesion based analysis of all patients (n=38)~Null hypothesis: patient distribution in contingency table is incidental."||||<0.001
72441426|NCT00174382|144396284|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.44|STANDARD_ERROR_OF_MEAN|0.33||0.182||95.0|-0.21|1.09||Baseline value, center, and week as fixed effects; subject was included as a random effect.|Mixed Models Analysis|||Week 12 Null hypothesis; change from baseline to the final visit = 0. Alternative hypothesis; change from baseline to final visit not = to 0. Sample of 260 participants was required for study to have 85% power to detect change from baseline to final visit of 0.73 in SMMSE total score, with a SD of 3.5. Fewer than 260 patients were enrolled, due to this loss in power the number of analyses specified in the protocol has been reduced and any analyses carried out will be exploratory in nature.||1.09|-0.21|0.182
72441427|NCT00174382|144396284|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.66|STANDARD_ERROR_OF_MEAN|0.36||0.067||95.0|-0.05|1.36|||Mixed Models Analysis|||Week 24 Null hypothesis; change from baseline to the final visit = 0. Alternative hypothesis; change from baseline to final visit not = to 0. Sample of 260 participants was required for study to have 85% power to detect change from baseline to final visit of 0.73 in SMMSE total score, with a SD of 3.5. Fewer than 260 patients were enrolled, due to this loss in power the number of analyses specified in the protocol has been reduced and any analyses carried out will be exploratory in nature.||1.36|-0.05|0.067
72441428|NCT00174382|144396284|SUPERIORITY_OR_OTHER|||||||0.085||95.0|||||Mixed Models Analysis|||Week 24 LOCF Null hypothesis; change from baseline to the final visit = 0. Alternative hypothesis; change from baseline to final visit not = to 0. Sample of 260 participants was required for study to have 85% power to detect change from baseline to final visit of 0.73 in SMMSE total score, with a SD of 3.5. Fewer than 260 patients were enrolled, due to this loss in power the number of analyses specified in the protocol has been reduced and any analyses carried out will be exploratory in nature.||||0.085
72496183|NCT01469000|144522272|SUPERIORITY||Hazard Ratio (HR)|1.26|||||TWO_SIDED|95.0|0.82|1.93||||||Observer-rated Fatigue: Time to worsening of symptom (TWS) was measured from the date of randomization to the first date of a 15-millimeter(mm) worsening from baseline on a scale of 0 (Severe) to 100 (None). This scoring system is the reverse of the patient scale. The observer scale is a categorical 5-point scale and specific descriptors are provided with each questions for each of the scores (0,25,50,75 and 100)||1.93|0.82|
72496184|NCT01469000|144522272|SUPERIORITY||Hazard Ratio (HR)|1.24|||||TWO_SIDED|95.0|0.72|2.15||||||Observer-rated Cough:Time to worsening of symptom (TWS) was measured from the date of randomization to the first date of a 15-millimeter(mm) worsening from baseline on a scale of 0 (Severe) to 100 (None). This scoring system is the reverse of the patient scale. The observer scale is a categorical 5-point scale and specific descriptors are provided with each questions for each of the scores (0,25,50,75 and 100)||2.15|0.72|
72441429|NCT00174382|144396285|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.0|STANDARD_ERROR_OF_MEAN|1.16||0.218||95.0|-1.2|5.19|||Mixed Models Analysis|||||5.19|-1.20|0.218
72559264|NCT02420353|144648202|OTHER|Mixed effects model||||||0.135|||||||Mixed Models Analysis|||||||0.135
72441430|NCT00174382|144396285|SUPERIORITY_OR_OTHER||Median Difference (Net)|-1.85|STANDARD_ERROR_OF_MEAN|2.12||0.385||95.0|-6.03|2.34|||Mixed Models Analysis|||||2.34|-6.03|0.385
72441431|NCT00174382|144396285|SUPERIORITY_OR_OTHER|||||||0.228||95.0|||||Mixed Models Analysis|||||||0.228
72441432|NCT00174382|144396286|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.84|STANDARD_ERROR_OF_MEAN|2.19||0.404||95.0|-2.51|6.18|||Mixed Models Analysis|||||6.18|-2.51|0.404
72441433|NCT00174382|144396286|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.57|STANDARD_ERROR_OF_MEAN|2.56||0.826||95.0|-4.51|5.64|||Mixed Models Analysis|||||5.64|-4.51|0.826
72441434|NCT00174382|144396286|SUPERIORITY_OR_OTHER|||||||0.494||95.0|||||Mixed Models Analysis|||||||0.494
72559265|NCT02420353|144648203|OTHER|Mixed effects model||||||0.6836|||||||Mixed Models Analysis|||||||0.6836
72559266|NCT02420353|144648204|OTHER|mixed effects model||||||0.9271|||||||Mixed Models Analysis|||||||0.9271
72441435|NCT00174382|144396287|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.78|STANDARD_ERROR_OF_MEAN|1.61||0.272||95.0|-1.42|4.99|||Mixed Models Analysis|||||4.99|-1.42|0.272
72441436|NCT00174382|144396287|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.27|STANDARD_ERROR_OF_MEAN|2.0||0.894||95.0|-4.21|3.68|||Mixed Models Analysis|||||3.68|-4.21|0.894
72441437|NCT00174382|144396287|SUPERIORITY_OR_OTHER|||||||0.906||95.0|||||Mixed Models Analysis|||||||0.906
72441438|NCT00174382|144396288|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.13|STANDARD_ERROR_OF_MEAN|0.35||0.719||95.0|-0.56|0.82|||Mixed Models Analysis|||||0.82|-0.56|0.719
72441439|NCT00174382|144396288|SUPERIORITY_OR_OTHER||Median Difference (Net)|1.0|STANDARD_ERROR_OF_MEAN|0.36||0.006||95.0|0.29|1.71|||Mixed Models Analysis|||||1.71|0.29|0.006
72441440|NCT00174382|144396288|SUPERIORITY_OR_OTHER|||||||0.007||95.0|||||Mixed Models Analysis|||||||0.007
72496185|NCT01469000|144522272|SUPERIORITY||Hazard Ratio (HR)|1.09|||||TWO_SIDED|95.0|0.64|1.83||||||Observer-rated Dyspnea: Time to worsening of symptom (TWS) was measured from the date of randomization to the first date of a 15-millimeter(mm) worsening from baseline on a scale of 0 (Severe) to 100 (None). This scoring system is the reverse of the patient scale. The observer scale is a categorical 5-point scale and specific descriptors are provided with each questions for each of the scores (0,25,50,75 and 100)||1.83|0.64|
72496186|NCT01469000|144522272|SUPERIORITY||Hazard Ratio (HR)|1.32|||||TWO_SIDED|95.0|0.6|2.91||||||Observer-rated Hemoptysis: Time to worsening of symptom (TWS) was measured from the date of randomization to the first date of a 15-millimeter(mm) worsening from baseline on a scale of 0 (Severe) to 100 (None). This scoring system is the reverse of the patient scale. The observer scale is a categorical 5-point scale and specific descriptors are provided with each questions for each of the scores (0,25,50,75 and 100)||2.91|0.60|
72496187|NCT01469000|144522272|SUPERIORITY||Hazard Ratio (HR)|0.65|||||TWO_SIDED|95.0|0.41|1.03||||||Observer-rated Pain: Time to worsening of symptom (TWS) was measured from the date of randomization to the first date of a 15-millimeter(mm) worsening from baseline on a scale of 0 (Severe) to 100 (None). This scoring system is the reverse of the patient scale. The observer scale is a categorical 5-point scale and specific descriptors are provided with each questions for each of the scores (0,25,50,75 and 100)||1.03|0.41|
72441441|NCT00174382|144396289|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.32|STANDARD_ERROR_OF_MEAN|0.35||0.368||95.0|-0.38|1.01|||Mixed Models Analysis|||||1.01|-0.38|0.368
72441442|NCT00174382|144396289|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.72|STANDARD_ERROR_OF_MEAN|0.33||0.03||95.0|0.07|1.37|||Mixed Models Analysis|||||1.37|0.07|0.030
72441443|NCT00174382|144396289|SUPERIORITY_OR_OTHER|||||||0.06||95.0|||||Mixed Models Analysis|||||||0.060
72496188|NCT00632853|144522303|SUPERIORITY|||||||0.8741|||||||Log Rank|||||||0.8741
72496189|NCT01462266|144522343|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.7||||0.009|TWO_SIDED|95.0|-8.3|-1.2|||Longitudinal data analysis|Adjusting for participant's use of metformin at Visit 1/Screening Visit (i.e., on metformin, or not on metformin)||||-1.2|-8.3|0.009
72496190|NCT01106846|144522348|SUPERIORITY_OR_OTHER|||||||0.947|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.947
72496191|NCT02065453|144522375|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||The data will be analyzed using linear regression, Kolmogorov-Smirnov test, and chi-square analysis.||||<0.001
72496192|NCT04426695|144522386|SUPERIORITY||Least Square (LS) Mean Difference|-0.25||||0.0663|TWO_SIDED|95.0|-0.51|0.02||P-value for change from baseline on log scale for each treatment group was based on the Analysis of covariance (ANCOVA) model with treatment group.|ANCOVA|||||0.02|-0.51|0.0663
72496193|NCT04426695|144522386|SUPERIORITY||Least Square (LS) Mean Difference|-0.31||||0.0204||95.0|-0.57|0.05||P-value for change from baseline on log scale for each treatment group was based on the Analysis of covariance (ANCOVA) model with treatment group.|ANCOVA|||||0.05|-0.57|0.0204
72559267|NCT02420353|144648205|OTHER|mixed effects model||||||0.1576|||||||Mixed Models Analysis|||||||0.1576
72441444|NCT00174382|144396290|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.21|STANDARD_ERROR_OF_MEAN|0.33||0.516||95.0|-0.44|0.86|||Mixed Models Analysis|||||0.86|-0.44|0.516
72441445|NCT00174382|144396290|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.34|STANDARD_ERROR_OF_MEAN|0.32||0.297||95.0|-0.97|0.3|||Mixed Models Analysis|||||0.30|-0.97|0.297
72441446|NCT00174382|144396290|SUPERIORITY_OR_OTHER|||||||0.133||95.0|||||Mixed Models Analysis|||||||0.133
72441447|NCT00174382|144396291|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.79|STANDARD_ERROR_OF_MEAN|0.33||0.02||95.0|0.13|1.45|||Mixed Models Analysis|||||1.45|0.13|0.020
72441448|NCT00174382|144396291|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.87|STANDARD_ERROR_OF_MEAN|0.36||0.018||95.0|0.16|1.59|||Mixed Models Analysis|||||1.59|0.16|0.018
72441449|NCT00174382|144396291|SUPERIORITY_OR_OTHER|||||||0.004||95.0|||||Mixed Models Analysis|||||||0.004
72441450|NCT00174382|144396292|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.1|STANDARD_ERROR_OF_MEAN|0.42||0.01||95.0|-1.93|-0.27|||Mixed Models Analysis|||||-0.27|-1.93|0.010
72441451|NCT00174382|144396292|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.12|STANDARD_ERROR_OF_MEAN|0.47||0.018||95.0|-2.05|-0.19|||Mixed Models Analysis|||||-0.19|-2.05|0.018
72441452|NCT00174382|144396292|SUPERIORITY_OR_OTHER|||||||0.018||95.0|||||Mixed Models Analysis|||||||0.018
72441453|NCT00174382|144396293|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.83|STANDARD_ERROR_OF_MEAN|0.62||0.182||95.0|-2.06|0.39|||Mixed Models Analysis|||||0.39|-2.06|0.182
72441454|NCT00174382|144396293|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.09|STANDARD_ERROR_OF_MEAN|0.68||0.114||95.0|-2.44|0.26|||Mixed Models Analysis|||||0.26|-2.44|0.114
72496194|NCT04426695|144522386|SUPERIORITY||Least Square (LS) Mean Difference|-0.28||||0.0172|TWO_SIDED|95.0|-0.51|-0.05||P-value for change from baseline on log scale for each treatment group was based on the Analysis of covariance (ANCOVA) model with treatment group.|ANCOVA|||To control alpha at a strict 0.05 level, this endpoint was tested hierarchically, with the virologic endpoint tested first. All hierarchical testing was done using the combined dose group.||-0.05|-0.51|0.0172
72496195|NCT04426695|144522387|SUPERIORITY|||||||0.0431||||||P-value was derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value was based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.0431
72559268|NCT02420353|144648206|OTHER|mixed effects model||||||0.5586|||||||Mixed Models Analysis|||||||0.5586
72559269|NCT02420353|144648207|OTHER|mixed effects model||||||0.45|||||||Mixed Models Analysis|||||||0.45
72559270|NCT02420353|144648208|OTHER|mixed effects model||||||0.8573|||||||Mixed Models Analysis|||||||0.8573
72559271|NCT02420353|144648209|OTHER|mixed effects model||||||0.0564|||||||Mixed Models Analysis|||||||0.0564
72441455|NCT00174382|144396293|SUPERIORITY_OR_OTHER|||||||0.038||95.0|||||Mixed Models Analysis|||||||0.038
72441456|NCT00296036|144396298|SUPERIORITY_OR_OTHER|||||||0.768|||||||Fisher Exact|||||||0.768
72441457|NCT01828554|144396313|OTHER|||||||0.4882||||||A paired t-test will be used to compare the PK parameters between the full weight and limited weight based dosing.|t-test, 2 sided|||The null hypothesis that the AUC from cycle 1 day 1 (based on ideal body weight) is equal to the AUC from cycle 1 day 9 (based on actual body weight) was tested against the alternative hypothesis that the AUCs are not equal. A linear mixed effect model with patient specific random effects was conducted||||0.4882
72441458|NCT01828554|144396314|OTHER|||||||0.7497||||||A paired t-test will be used to compare the PK parameters between the full weight and limited weight based dosing.|t-test, 2 sided|||||||0.7497
72441459|NCT03951805|144396317|OTHER||Treatment difference|0.76||||0.7675|TWO_SIDED|95.0|-4.28|5.8|||ANCOVA|||The response and change from baseline in response during the last two weeks of treatment (week 15 and 16) are analysed using an analysis of covariance (ANCOVA) model with treatment and SGLT2i use as fixed factors, and baseline response as covariate. Missing endpoint values are imputed using multiple imputation based on own treatment arm with baseline response as a covariate. Each imputed dataset is analysed separately and estimates are combined using Rubin's rules.||5.80|-4.28|0.7675
72441460|NCT03951805|144396317|OTHER||Treatment difference|7.08||||0.0051|TWO_SIDED|95.0|2.12|12.04|||ANCOVA|||The response and change from baseline in response during the last two weeks of treatment (week 15 and 16) are analysed using an analysis of covariance (ANCOVA) model with treatment and SGLT2i use as fixed factors, and baseline response as covariate. Missing endpoint values are imputed using multiple imputation based on own treatment arm with baseline response as a covariate. Each imputed dataset is analysed separately and estimates are combined using Rubin's rules.||12.04|2.12|0.0051
72441461|NCT03951805|144396317|OTHER||Treatment difference|5.01||||0.0519|TWO_SIDED|95.0|-0.04|10.05|||ANCOVA|||The response and change from baseline in response during the last two weeks of treatment (week 15 and 16) are analysed using an analysis of covariance (ANCOVA) model with treatment and SGLT2i use as fixed factors, and baseline response as covariate. Missing endpoint values are imputed using multiple imputation based on own treatment arm with baseline response as a covariate. Each imputed dataset is analysed separately and estimates are combined using Rubin's rules.||10.05|-0.04|0.0519
72441462|NCT04583423|144396326|OTHER||Difference in Percentages|10.4||||0.3504|TWO_SIDED|95.0|-13.4|35.1|||Miettinen and Nurminen's method|Stratified by concurrent diagnosis of T2DM at the time of randomization and fibrosis score and using Cochran-Mantel-Haenszel weighting scheme|Difference=% 50-mg MK-3655 minus % placebo|||35.1|-13.4|0.3504
72441463|NCT04583423|144396326|OTHER||Difference in Percentages|9.2||||0.373|TWO_SIDED|95.0|-15.6|32.1|||Miettinen and Nurminen's method|Stratified by concurrent diagnosis of T2DM at the time of randomization and fibrosis score and using Cochran-Mantel-Haenszel weighting scheme|Difference=% 100-mg MK-3655 minus % placebo|||32.1|-15.6|0.3730
72441464|NCT04583423|144396326|OTHER||Difference in Percentages|15.4||||0.1428|TWO_SIDED|95.0|-8.5|42.3|||Miettinen and Nurminen's method|Stratified by concurrent diagnosis of T2DM at the time of randomization and fibrosis score and using Cochran-Mantel-Haenszel weighting scheme|Difference=% 300-mg MK-3655 minus % placebo|||42.3|-8.5|0.1428
72559272|NCT02420353|144648210|OTHER|mixed effects model||||||0.7883|||||||Mixed Models Analysis|||||||0.7883
72559273|NCT02420353|144648211|OTHER|mixed effects model||||||0.0901|||||||Mixed Models Analysis|||||||0.0901
72441465|NCT04583423|144396329|OTHER||Difference in Least Square (LS) Means|19.1|||||TWO_SIDED|95.0|1.7|36.4|||||Difference=LS Mean 50 mg minus LS Mean Placebo|||36.4|1.7|
72559274|NCT02420353|144648212|OTHER|mixed effects model||||||0.6292|||||||Mixed Models Analysis|||||||0.6292
72441466|NCT04583423|144396329|OTHER||Difference in LS Means|19.0|||||TWO_SIDED|95.0|2.2|35.8|||||Difference=LS Mean 100 mg minus LS Mean Placebo|||35.8|2.2|
72441467|NCT04583423|144396329|OTHER||Difference in LS Means|26.1|||||TWO_SIDED|95.0|9.5|42.8|||||Difference=LS Mean 300 mg minus LS Mean Placebo|||42.8|9.5|
72441468|NCT04583423|144396330|OTHER||Difference in Percentages|1.6||||0.8978|TWO_SIDED|95.0|-26.5|30.3|||Miettinen and Nurminen's method|Stratified by concurrent diagnosis of T2DM at the time of randomization and fibrosis score and using Cochran-Mantel-Haenszel weighting scheme|Difference=% 50 mg minus % Placebo|||30.3|-26.5|0.8978
72441469|NCT04583423|144396330|OTHER||Difference in Parentages|20.0||||0.1869|TWO_SIDED|95.0|-10.6|46.4|||Miettinen and Nurminen's method|Stratified by concurrent diagnosis of T2DM at the time of randomization and fibrosis score and using Cochran-Mantel-Haenszel weighting scheme|Difference=% 100 mg minus % Placebo|||46.4|-10.6|0.1869
72441470|NCT04583423|144396330|OTHER||Difference in Percentages|8.5||||0.5636|TWO_SIDED|95.0|-22.1|38.5|||Miettinen and Nurminen's method|Stratified by concurrent diagnosis of T2DM at the time of randomization and fibrosis score and using Cochran-Mantel-Haenszel weighting scheme|Difference=% 300 mg minus % Placebo|||38.5|-22.1|0.5636
72441471|NCT04583423|144396331|OTHER||Difference in Percentages|1.6||||0.9174|TWO_SIDED|95.0|-28.6|32.6|||Miettinen and Nurminen's method|Stratified by concurrent diagnosis of T2DM at the time of randomization and fibrosis score and using Cochran-Mantel-Haenszel weighting scheme|Difference=% 50 mg minus % Placebo|||32.6|-28.6|0.9174
72441472|NCT04583423|144396331|OTHER||Difference in Percentages|18.5||||0.272|TWO_SIDED|95.0|-14.5|47.1|||Miettinen and Nurminen's method|Stratified by concurrent diagnosis of T2DM at the time of randomization and fibrosis score and using Cochran-Mantel-Haenszel weighting scheme|Difference=% 100 mg minus % Placebo|||47.1|-14.5|0.2720
72559275|NCT02420353|144648213|OTHER|mixed effects model||||||0.161|||||||Mixed Models Analysis|||||||0.161
72559276|NCT02420353|144648214|OTHER|mixed effects model||||||0.4437|||||||Mixed Models Analysis|||||||0.4437
72559277|NCT02420353|144648215|OTHER|mixed effects model||||||0.7325|||||||Mixed Models Analysis|||||||0.7325
72559278|NCT02420353|144648216|OTHER|Mixed effects analysis||||||0.6291|||||||Mixed Models Analysis|||||||0.6291
72559279|NCT02420353|144648217|OTHER|Mixed-effects model||||||0.3332|||||||Mixed Models Analysis|||||||0.3332
72559280|NCT02420353|144648218|OTHER|Mixed effects analysis||||||0.79|||||||Mixed Models Analysis|||||||0.79
72559281|NCT02420353|144648219|OTHER|Mixed effects analysis||||||0.4965|||||||Mixed Models Analysis|||||||0.4965
72559282|NCT02420353|144648220|OTHER|mixed effects analysis||||||0.1331|||||||Mixed Models Analysis|||||||0.1331
72441473|NCT04583423|144396331|OTHER||Difference in Percentages|5.3||||0.7586|TWO_SIDED|95.0|-26.7|37.3|||Miettinen and Nurminen's method|Stratified by concurrent diagnosis of T2DM at the time of randomization and fibrosis score and using Cochran-Mantel-Haenszel weighting scheme|Difference= % 300 mg minus % Placebo|||37.3|-26.7|0.7586
72441474|NCT00603954|144396352|SUPERIORITY|||||||0.508|||||||Multivariate Cox models|||||||0.508
72441475|NCT00603954|144396352|SUPERIORITY|||||||0.02|||||||Wilcoxon (Mann-Whitney)|||At day 180||||0.02
72441476|NCT00603954|144396352|SUPERIORITY|||||||0.002|||||||Wilcoxon (Mann-Whitney)|||At Day 365||||0.002
72441477|NCT00603954|144396353|SUPERIORITY|||||||0.09|||||||Wilcoxon (Mann-Whitney)|||At day 100||||0.09
72441478|NCT00603954|144396353|SUPERIORITY|||||||0.03|||||||Wilcoxon (Mann-Whitney)|||At Day 40||||0.03
72441479|NCT00603954|144396353|SUPERIORITY|||||||0.01|||||||Wilcoxon (Mann-Whitney)|||At Day 180||||0.01
72441480|NCT00603954|144396354|SUPERIORITY|||||||0.0165|||||||Multivariate Cox models|||||||0.0165
72441481|NCT00603954|144396354|SUPERIORITY||Hazard Ratio (HR)|0.3||||0.01|TWO_SIDED|95.0|||||Mutivariate|||||||0.010
72441482|NCT00603954|144396354|SUPERIORITY||Hazard Ratio (HR)|0.5||||0.0495|TWO_SIDED|95.0|||||Multivariate|||||||0.0495
72559283|NCT02420353|144648221|OTHER|Mixed-model analysis||||||0.5251|||||||Mixed Models Analysis|||||||0.5251
72559284|NCT02420353|144648222|OTHER|Mixed effects analysis||||||0.1064|||||||Mixed Models Analysis|||||||0.1064
72441483|NCT00603954|144396354|SUPERIORITY||Hazard Ratio (HR)|3.8||||0.001|TWO_SIDED|95.0|||||Multivariate|||||||0.001
72441484|NCT00603954|144396355|SUPERIORITY|||||||0.15|||||||Fisher Exact|||19 of 49 Flu-TBI patients (39%) versus 25 of 45 TLI ATG patients (56%) had a least one episode of bacterial infection the first 100 days after transplantation (P = 0.15).||||0.15
72441485|NCT00603954|144396355|SUPERIORITY|||||||0.19|||||||Fisher Exact|||For fungal infections, the figures were 3 of 45 (6%) and 7 of 45 (16%), respectively (P = 0.19)||||0.19
72441486|NCT00603954|144396355|SUPERIORITY|||||||0.12|||||||Fisher Exact|||Among CMV-seropositive patients and/or donors, the 100-day cumulative incidence of CMV reactivation was 31% in Flu-TBI patients versus 47% in TLI-ATG patient||||0.12
72441487|NCT00603954|144396356|SUPERIORITY||Multivariate Cox models|2.3|STANDARD_DEVIATION|0.02||0.017|TWO_SIDED|95.0|1.1|4.7|||Cumulative incidence curves|||Four-year cumulative incidences of relapse/progression were 22% and 50% in Flu-TBI and TLI-ATG patients, respectively||4.7|1.1|0.017
72441488|NCT00603954|144396357|SUPERIORITY||Median Difference (Final Values)|4.0|||||TWO_SIDED|||||||||This statistical analysis applies to median ATG serum levels at day 0||||
72441489|NCT00603954|144396357|SUPERIORITY||Mean Difference (Final Values)|2.2|||||TWO_SIDED|||||||||This statistical analysis applies to median ATG serum levels at day 3||||
72441490|NCT00603954|144396357|SUPERIORITY||Mean Difference (Final Values)|0.95|||||TWO_SIDED|||||||||This statistical analysis applies to median ATG serum levels at day 10||||
72441491|NCT00603954|144396358|SUPERIORITY|||||||0.5|||||||Cumulative incidence curve|||||||0.5
72441492|NCT00603954|144396359|SUPERIORITY||multivariate analyses|2.0|STANDARD_DEVIATION|0.07||0.14|TWO_SIDED|95.0|1.0|4.1|||Kaplan-Meier method|||||4.1|1|0.14
72441493|NCT00603954|144396361|SUPERIORITY||multivariate analyses|1.2|STANDARD_DEVIATION|0.02||0.9|TWO_SIDED|95.0|1.0|1.4|||Kaplan-Meier method|||||1.4|1|0.9
72441494|NCT00603954|144396362|SUPERIORITY||multivariate analyses|1.2|STANDARD_DEVIATION|0.02||0.96|TWO_SIDED|95.0|1.0|1.4|||Kaplan-Meier method|||||1.4|1|0.96
72441495|NCT01066026|144396363|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|pilot study.|descritive variables|50.0|||<|0.0001|TWO_SIDED|95.0|5.0|95.0|||McNemar||50 was the percentage of hematomas expected for standard needle group.|||95|5|<0.0001
72441496|NCT02238483|144396378|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.39||||0.2371|TWO_SIDED|95.0|0.81|2.4|||Regression, Cox||A hazard ratio greater than 1 indicates a higher rate of incidence in the AZD7624 group.|H0: Hazard Ratio (AZD7624/placebo) equals 1 vs. H1: Hazard Ratio does not equal 1.||2.40|0.81|0.2371
72441497|NCT02238483|144396379|SUPERIORITY_OR_OTHER||Rate Ratio|1.33|STANDARD_ERROR_OF_MEAN|0.33||0.249|TWO_SIDED|95.0|0.82|2.16|||regression, negative binomial||A hazard ratio greater than 1 indicates a higher rate of incidence in the AZD7624 group.|||2.16|0.82|0.249
72441498|NCT02238483|144396380|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.49||||0.1261|TWO_SIDED|95.0|0.89|2.5|||Regression, Cox||A hazard ratio greater than 1 indicates a higher rate of incidence in the AZD7624 group.|||2.50|0.89|0.1261
72441499|NCT02238483|144396381|SUPERIORITY_OR_OTHER||Rate ratio|1.4|STANDARD_ERROR_OF_MEAN|0.33||0.157|TWO_SIDED|95.0|0.88|2.21|||regression, negative binomial|||||2.21|0.88|0.157
72441500|NCT02238483|144396382|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.53||||0.1529|TWO_SIDED|95.0|0.85|2.76|||Regression, Cox|||||2.76|0.85|0.1529
72441501|NCT02238483|144396383|SUPERIORITY_OR_OTHER||rate ratio|1.5|STANDARD_ERROR_OF_MEAN|0.4||0.129|TWO_SIDED|95.0|0.89|2.52|||regression, negative binomial|||||2.52|0.89|0.129
72441502|NCT02238483|144396384|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.93||||0.8543|TWO_SIDED|95.0|0.43|2.01|||Regression, Cox||A hazard ratio greater than 1 indicates a higher rate of incidence in the AZD7624 group.|||2.01|0.43|0.8543
72441503|NCT02238483|144396385|SUPERIORITY_OR_OTHER||rate ratio|1.12|STANDARD_ERROR_OF_MEAN|0.41||0.751|TWO_SIDED|95.0|0.55|2.29|||regression, negative binomial|||||2.29|0.55|0.751
72441504|NCT02238483|144396386|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.86||||0.5381|TWO_SIDED|95.0|0.54|1.38|||Regression, Cox||A hazard ratio greater than 1 indicates a higher rate of incidence in the AZD7624 group.|||1.38|0.54|0.5381
72441505|NCT02238483|144396387|SUPERIORITY_OR_OTHER||rate ratio|0.84|STANDARD_ERROR_OF_MEAN|0.19||0.44|TWO_SIDED|95.0|0.55|1.3|||regression, negative binomial|||||1.30|0.55|0.440
72441506|NCT02238483|144396388|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.37||||0.5474|TWO_SIDED|95.0|-1.6|0.85|||Mixed Models Analysis||LSMean difference for overall treatment effect. Negative values for a difference show AZD7624 to have a favourable outcome compared to Placebo|||0.85|-1.60|0.5474
72559285|NCT02420353|144648223|OTHER|Mixed effects analysis||||||0.4852|||||||Mixed Models Analysis|||||||0.4852
72559286|NCT02420353|144648224|OTHER|||||||0.7943|||||||Mixed Models Analysis|||||||0.7943
72559287|NCT02420353|144648225|OTHER|||||||0.0894|||||||Mixed Models Analysis|||||||0.0894
72559288|NCT02420353|144648226|OTHER|Mixed effects analysis||||||0.0673|||||||Mixed Models Analysis|||||||0.0673
72559289|NCT02420353|144648227|OTHER|Mixed effects analysis||||||0.0185|||||||Mixed Models Analysis|||||||0.0185
72441507|NCT02238483|144396389|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.83||||0.6352|TWO_SIDED|95.0|-2.62|4.29|||Mixed Models Analysis||LSMean difference for overall treatment effect. Positive values for a difference show AZD7624 to have a favourable outcome compared to Placebo|||4.29|-2.62|0.6352
72441508|NCT02238483|144396390|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.12||||0.2694|TWO_SIDED|95.0|-0.34|0.1|||Mixed Models Analysis||LSMean difference for overall treatment effect. Positive values for a difference show AZD7624 to have a favourable outcome compared to Placebo|||0.10|-0.34|0.2694
72441509|NCT02238483|144396391|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.02||||0.5144|TWO_SIDED|95.0|-0.03|0.07|||Mixed Models Analysis||LSMean difference for overall treatment effect. Positive values for a difference show AZD7624 to have a favourable outcome compared to Placebo|||0.07|-0.03|0.5144
72441510|NCT02238483|144396392|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.02||||0.5416|TWO_SIDED|95.0|-0.1|0.05|||Mixed Models Analysis||LSMean difference for overall treatment effect. Positive values for a difference show AZD7624 to have a favourable outcome compared to Placebo|||0.05|-0.10|0.5416
72441511|NCT02238483|144396393|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.01||||0.1965|TWO_SIDED|95.0|0.0|0.02|||Mixed Models Analysis||LSMean difference for overall treatment effect. Positive values for a difference show AZD7624 to have a favourable outcome compared to Placebo|||0.02|0.00|0.1965
72441512|NCT02574455|144396397|OTHER||Hazard Ratio (HR)|0.387|||<|0.0001|TWO_SIDED|95.0|0.305|0.492||Stratified log-rank test and stratified Cox regression adjusted for stratification factors: number of prior chemotherapies, presence of known brain metastases at study entry, and region.|Log Rank|||||0.492|0.305|<0.0001
72441513|NCT02574455|144396398|OTHER||Hazard Ratio (HR)|0.413|||<|0.0001|TWO_SIDED|95.0|0.33|0.517||Stratified log-rank test and stratified Cox regression adjusted for stratification factors: number of prior chemotherapies, presence of known brain metastases at study entry, and region.|Log Rank|||||0.517|0.330|<0.0001
72441514|NCT02574455|144396399|OTHER||Hazard Ratio (HR)|0.481|||<|0.0001|TWO_SIDED|95.0|0.39|0.592||Stratified log-rank test and stratified Cox regression adjusted for stratification factors: number of prior chemotherapies and region.|Log Rank|||||0.592|0.390|<0.0001
72441515|NCT02574455|144396400|OTHER||Hazard Ratio (HR)|0.514|||<|0.0001|TWO_SIDED|95.0|0.422|0.625||Stratified log-rank test and stratified Cox regression adjusted for stratification factors: number of prior chemotherapies and region.|Log Rank|||||0.625|0.422|<0.0001
72441516|NCT02574455|144396401|OTHER||Odds Ratio (OR)|10.859|||<|0.0001|TWO_SIDED|95.0|5.59|21.095|||Cochran-Mantel-Haenszel|||ORR by IRC Assessment||21.095|5.590|<0.0001
72441517|NCT02574455|144396401|OTHER||Odds Ratio (OR)|7.363|||<|0.0001|TWO_SIDED|95.0|4.063|13.341|||Cochran-Mantel-Haenszel|||ORR by Investigator Assessment||13.341|4.063|<0.0001
72441518|NCT02574455|144396404|OTHER||Hazard Ratio (HR)|0.407||||0.0683|TWO_SIDED|95.0|0.15|1.107||Stratified log-rank test and stratified Cox regression adjusted for stratification factors: number of prior chemotherapies, and region.|Log Rank|||DOR by IRC Assessment||1.107|0.150|0.0683
72441519|NCT02574455|144396404|OTHER||Hazard Ratio (HR)|0.212|||<|0.0001|TWO_SIDED|95.0|0.103|0.435||Stratified log-rank test and stratified Cox regression adjusted for stratification factors: number of prior chemotherapies, and region.|Log Rank|||DOR by Investigator Assessment||0.435|0.103|<0.0001
72441520|NCT02574455|144396405|OTHER||Hazard Ratio (HR)|0.317|||<|0.0001|TWO_SIDED|95.0|0.248|0.404||Stratified log-rank test and stratified Cox regression adjusted for stratification factors: number of prior chemotherapies and region.|Log Rank|||TTP by Investigator Assessment||0.404|0.248|<0.0001
72441521|NCT02574455|144396406|OTHER||Hazard Ratio (HR)|0.406|||<|0.0001|TWO_SIDED|95.0|0.315|0.525||Stratified log-rank test and stratified Cox regression adjusted for stratification factors: number of prior chemotherapies and region.|Log Rank|||TTP by IRC Assessment||0.525|0.315|<0.0001
72441522|NCT02574455|144396407|OTHER||Odds Ratio (OR)|8.543|||<|0.0001|TWO_SIDED|95.0|5.055|14.437|||Cochran-Mantel-Haenszel|||CBR by IRC Assessment||14.437|5.055|<0.0001
72441523|NCT02574455|144396407|OTHER||Odds Ratio (OR)|7.492|||<|0.0001|TWO_SIDED|95.0|4.54|12.364|||Cochran-Mantel-Haenszel|||CBR by Investigator Assessment||12.364|4.540|<0.0001
72441524|NCT02677896|144396411|SUPERIORITY||Cox hazard ratio|0.39|||<|0.0001|TWO_SIDED|95.0|0.3|0.5||Stratified by volume of disease (low vs high) and prior docetaxel use (yes vs no) during screening period.|Log Rank||Stratified by volume of disease (low vs high) and prior docetaxel use (yes vs no) during screening period.|rPFS Treatment Comparison||0.50|0.30|<0.0001
72441525|NCT02677896|144396412|SUPERIORITY||Cox proportional hazards model|0.39|||<|0.0001|TWO_SIDED|95.0|0.3|0.5|||Log Rank|||rPFS Treatment Comparision||0.50|0.30|<0.0001
72441526|NCT02677896|144396413|SUPERIORITY||Hazard Ratio (HR)|0.66|||<|0.0001|TWO_SIDED|95.0|0.53|0.81|||Log Rank|P-value from stratified log-rank test.|Significance level is 0.04. Hazard ratio and 95 % CI are estimated by cox proportional hazards model.|||0.81|0.53|<0.0001
72441527|NCT02677896|144396414|SUPERIORITY||Cox hazard ratio|0.19|||<|0.0001|TWO_SIDED|95.0|0.13|0.26||Stratified by volume of disease (low vs high) and prior docetaxel use (yes vs no) during screening period.|Log Rank||Stratified by volume of disease (low vs high) and prior docetaxel use (yes vs no) during screening period.|Time to PSA Progression Treatment Comparison||0.26|0.13|<0.0001
72441528|NCT02677896|144396415|SUPERIORITY||Hazard Ratio (HR)|0.38|||||TWO_SIDED|95.0|0.31|0.48|||||Hazard ratio and 95 % CI are estimated by cox proportional hazards model.|||0.48|0.31|
72441529|NCT02677896|144396416|SUPERIORITY||Difference in rate|50.5|||<|0.0001|TWO_SIDED|95.0|45.3|55.7||Stratified by volume of disease (low vs high) and prior docetaxel use (yes vs no) during screening period.|Cochran-Mantel-Haenszel|||PSA Undetectable Rate Treatment Comparison||55.7|45.3|<0.0001
72441530|NCT02677896|144396417|SUPERIORITY||Difference in rate|19.3|||<|0.0001|TWO_SIDED|95.0|10.4|28.2||Stratified by volume of disease (low vs high) and prior docetaxel use (yes vs no) during screening period.|Cochran-Mantel-Haenszel|||ORR Treatment Comparison||28.2|10.4|<0.0001
72441531|NCT02677896|144396418|SUPERIORITY||Cox hazard ratio|0.88||||0.2162|TWO_SIDED|95.0|0.72|1.08||Stratified by volume of disease (low vs high) and prior docetaxel use (yes vs no) during screening period.|Log Rank||Stratified by volume of disease (low vs high) and prior docetaxel use (yes vs no) during screening period.|Time to Deterioration of Urinary Symptoms Treatment Comparison||1.08|0.72|0.2162
72441532|NCT02677896|144396419|SUPERIORITY||Cox hazard ratio|0.52||||0.0026|TWO_SIDED|95.0|0.33|0.8|||Log Rank|||Time to SSE Treatment Comparison||0.80|0.33|0.0026
72441533|NCT02677896|144396420|SUPERIORITY||Cox hazard ratio|0.28|||<|0.0001|TWO_SIDED|95.0|0.22|0.36|||Log Rank|||Time to Castration Resistance Treatment Comparison||0.36|0.22|<0.0001
72441534|NCT02677896|144396421|SUPERIORITY||Cox hazard ratio|0.96||||0.6548|TWO_SIDED|95.0|0.81|1.14|||Log Rank|||Time to Deterioration of QoL in FACT-P Treatment Comparison||1.14|0.81|0.6548
72441535|NCT02677896|144396422|SUPERIORITY||Cox hazard ratio|0.92||||0.2715|TWO_SIDED|95.0|0.78|1.07|||Log Rank|||Time to Pain Progression Based on BPI-SF Treatment Comparison||1.07|0.78|0.2715
72441536|NCT00539734|144396425|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Wilcoxon (Mann-Whitney)|||Comparing pre-operative data with postoperative data in terms of changes in amplitude height and implicit time.||||<0.05
72441537|NCT03631550|144396428|SUPERIORITY|||||||0.018|||||||Chi-squared|||||||0.018
72441538|NCT03631550|144396429|SUPERIORITY|||||||0.0466|||||||Chi-squared|||||||0.0466
72496196|NCT04426695|144522387|SUPERIORITY|||||||0.7975||||||P-value was derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value was based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.7975
72496197|NCT04426695|144522387|SUPERIORITY|||||||0.2048||||||P-value was derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value was based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||To control alpha at a strict 0.05 level, this endpoint was tested hierarchically, with the virologic endpoint tested first. All hierarchical testing was done using the combined dose group.||||0.2048
72496198|NCT04426695|144522388|SUPERIORITY|||||||0.0039||||||P-value was derived CMH test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value was based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.0039
72496199|NCT04426695|144522388|SUPERIORITY|||||||0.2415||||||P-value was derived CMH test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value was based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.2415
72559290|NCT02420353|144648228|OTHER|mixed effects analysis||||||0.6094|||||||Mixed Models Analysis|||||||0.6094
72559291|NCT02420353|144648229|OTHER|mixed effects analysis||||||0.3279|||||||Mixed Models Analysis|||||||0.3279
72559292|NCT02420353|144648230|OTHER|mixed effects analysis||||||0.2802|||||||Mixed Models Analysis|||||||0.2802
72441539|NCT03631550|144396430|SUPERIORITY|||||||0.0677|||||||Chi-squared|||||||0.0677
72496200|NCT04426695|144522388|SUPERIORITY|||||||0.0195||||||P-value was derived CMH test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value was based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||To control alpha at a strict 0.05 level, this endpoint was tested hierarchically, with the virologic endpoint tested first. All hierarchical testing was done using the combined dose group.||||0.0195
72496201|NCT04426695|144522389|SUPERIORITY|||||||0.0085||||||P-value was derived CMH test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< = 5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.0085
72441540|NCT03631550|144396431|SUPERIORITY||||||<|0.0001|||||||Chi-squared|||||||<.0001
72441541|NCT03631550|144396432|OTHER|||||||0.0968|||||||Fisher Exact|||||||0.0968
72441542|NCT03631550|144396433|SUPERIORITY|||||||0.0121|||||||ANCOVA|||||||0.0121
72441543|NCT02692417|144396455|OTHER|||||||0.109|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon signed rank test comparing FSFI score from baseline to time point.||||0.109
72441544|NCT02692417|144396455|OTHER|||||||0.225|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon signed rank test comparing FSFI score from baseline to time point.||||0.225
72441545|NCT02692417|144396456|OTHER|||||||0.109|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon signed rank test comparing FSFI score from baseline to time point.||||0.109
72441546|NCT02692417|144396456|OTHER|||||||0.046|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon signed rank test comparing FSFI score from baseline to time point.||||0.046
72441547|NCT02692417|144396457|OTHER|||||||0.109|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon signed rank test comparing FSFI score from baseline to time point.||||0.109
72441548|NCT02692417|144396457|OTHER|||||||0.028|||||||Wilcoxon (Mann-Whitney)|||||||0.028
72441549|NCT03010631|144396473|SUPERIORITY||Ratio of Geometric LS Means|1.441|||||TWO_SIDED|90.0|1.166|1.782||||||||1.782|1.166|
72441550|NCT03010631|144396474|SUPERIORITY||Ratio of Geometric LS Means|2.045|||||TWO_SIDED|90.0|1.615|2.589||||||||2.589|1.615|
72441551|NCT03010631|144396475|OTHER||Ratio of Geometric LS Means|0.888|||||TWO_SIDED|90.0|0.675|1.168||||||||1.168|0.675|
72441552|NCT03010631|144396476|OTHER||Ratio of Geometric LS Means|0.413|||||TWO_SIDED|90.0|0.339|0.502||||||||0.502|0.339|
72441553|NCT01255670|144396480|OTHER|Mann-Whitney U-test and Fisher's exact test||||||0.05|||||||Fisher Exact|||||||0.05
72441554|NCT01255670|144396481|OTHER|||||||0.05|||||||Wilcoxon (Mann-Whitney)|||Mann-Whitney U-test and Fisher's exact test||||0.05
72441555|NCT02269475|144396482|SUPERIORITY_OR_OTHER||Vaccine efficacy (%)|100.0|||||TWO_SIDED|95.0|-1875.3|100.0||"No statistical tests were used, instead the confidence interval was used for showing superiority.~If lower bound of the 95% CI is greater than 0%, the efficacy of MEDI3250 is demonstrated."|Exact conditional method|Estimated by an exact conditional method in total number of cases which follows a Poisson assumption.|Vaccine efficacy (%) = (1-RR)\*100 where RR = Risk Reduction.|||100.0|-1875.3|
72496202|NCT04426695|144522389|SUPERIORITY|||||||0.9902||||||P-value was derived CMH test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< = 5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.9902
72559293|NCT02420353|144648231|OTHER|||||||0.1064|||||||Mixed Models Analysis|||||||0.1064
72559294|NCT02420353|144648232|OTHER|mixed effects model||||||0.0509|||||||Mixed Models Analysis|||||||0.0509
72559295|NCT02420353|144648233|OTHER|mixed effects analysis||||||0.1605|||||||Mixed Models Analysis|||||||0.1605
72559296|NCT02420353|144648234|OTHER|mixed effects model||||||0.0357|||||||Mixed Models Analysis|||||||0.0357
72559297|NCT02420353|144648235|OTHER|mixed effects model||||||0.0122|||||||Mixed Models Analysis|||||||0.0122
72559298|NCT02420353|144648236|OTHER|mixed effects model||||||0.5853|||||||Mixed Models Analysis|||||||0.5853
72441556|NCT02269475|144396483|SUPERIORITY_OR_OTHER||Vaccine efficacy (%)|27.5|||||TWO_SIDED|95.0|7.4|43.0||"No statistical tests were used, instead the confidence interval was used for showing superiority.~If lower bound of the 95% CI is greater than 0%, the efficacy of MEDI3250 is demonstrated."|Exact conditional method|Estimated by an exact conditional method in total number of cases which follows a Poisson assumption.|Vaccine efficacy (%) = (1-RR)\*100 where RR = Risk Reduction.|||43.0|7.4|
72441557|NCT01996605|144396485|SUPERIORITY||||||<|0.05||||||T|ANOVA|A one-way ANOVA was performed on the single primary outcome datapoint comparing the three groups.||The null hypothesis was that there would be no difference in area of hyperalgesia 105 minutes after study drug injection among the three groups.||||<0.05
72441558|NCT02769858|144396500|OTHER|||||||0.001|||||||t-test, 2 sided|||||||.001
72441559|NCT02769858|144396501|OTHER|||||||0.019|||||||t-test, 2 sided|||||||.019
72441560|NCT02769858|144396502|OTHER|||||||0.502|||||||t-test, 2 sided|||||||.502
72441561|NCT01853748|144396513|SUPERIORITY|||||||0.0012|||||||Mantel Haenszel|||||||0.0012
72441562|NCT01853748|144396518|SUPERIORITY|||||||0.0001|||||||Regression, Linear|||||||0.0001
72441563|NCT01853748|144396521|SUPERIORITY|||||||0.0001|||||||Fisher Exact|||||||0.0001
72441564|NCT04524390|144396658|SUPERIORITY||Least-Square mean|-0.39|STANDARD_ERROR_OF_MEAN|1.182||0.7419|TWO_SIDED|95.0|-2.76|1.97|||MMRM|||||1.97|-2.76|0.7419
72441565|NCT04524390|144396659|SUPERIORITY||Least-Square mean|-45.9|STANDARD_ERROR_OF_MEAN|35.398||0.2002|TWO_SIDED|95.0|-116.86|25.05|||MMRM|||||25.05|-116.86|0.2002
72441566|NCT04524390|144396660|SUPERIORITY|||||||0.8412|||||||Barnard's exact test|||||||0.8412
72441567|NCT04524390|144396661|SUPERIORITY||||||>|0.9999|||||||Barnard's exact test|||||||> 0.9999
72496203|NCT04426695|144522389|SUPERIORITY|||||||0.1486||||||P-value was derived CMH test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< = 5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||To control alpha at a strict 0.05 level, this endpoint was tested hierarchically, with the virologic endpoint tested first. All hierarchical testing was done using the combined dose group.||||0.1486
72441568|NCT04524390|144396662|SUPERIORITY|||||||0.6658|||||||Barnard's exact test|||||||0.6658
72441569|NCT04524390|144396663|SUPERIORITY|||||||0.6236|||||||Barnard's exact test|||||||0.6236
72441570|NCT04524390|144396664|SUPERIORITY|||||||0.6658|||||||Barnard's exact test|||||||0.6658
72441571|NCT04524390|144396665|SUPERIORITY|||||||0.6659|||||||Barnard's exact test|||||||0.6659
72441572|NCT02217904|144396670|SUPERIORITY||Posterior mean difference|-1.64|||||||||||||Posterior Probability (PP) of true mean difference in the plasma HIV-1 RNA change from baseline between islatravir and placebo at least 0.5 log10 copies/mL was \>99%.|Adjusted by Placebo data pooled from historical placebo data from recent monotherapy studies in HIV-1 infected participants (NCT00100048, NCT01466985, NCT01152255, and NCT01353898) and fitted with a longitudinal data analysis (LDA) model containing fixed effects for study and time, and a random effect for participants. LS mean of pooled historical placebo data was -0.03 log10 copies/mL (95% CI -014, 0.09) change from baseline at 168 hours post dose.||||
72441573|NCT02217904|144396670|SUPERIORITY||Posterior mean difference|-1.32|||||||||||||Posterior Probability (PP) of true mean difference in the plasma HIV-1 RNA change from baseline between islatravir and placebo at least 0.5 log10 copies/mL was \>99%.|Adjusted by Placebo data pooled from historical placebo data from recent monotherapy studies in HIV-1 infected participants (NCT00100048, NCT01466985, NCT01152255, and NCT01353898) and fitted with a longitudinal data analysis (LDA) model containing fixed effects for study and time, and a random effect for participants. LS mean of pooled historical placebo data was -0.03 log10 copies/mL (95% CI -014, 0.09) change from baseline at 168 hours post dose.||||
72441574|NCT02217904|144396670|SUPERIORITY||Posterior mean difference|-1.57|||||||||||||Posterior Probability (PP) of true mean difference in the plasma HIV-1 RNA change from baseline between islatravir and placebo at least 0.5 log10 copies/mL was \>99%.|Adjusted by Placebo data pooled from historical placebo data from recent monotherapy studies in HIV-1 infected participants (NCT00100048, NCT01466985, NCT01152255, and NCT01353898) and fitted with a longitudinal data analysis (LDA) model containing fixed effects for study and time, and a random effect for participants. LS mean of pooled historical placebo data was -0.03 log10 copies/mL (95% CI -014, 0.09) change from baseline at 168 hours post dose.||||
72441575|NCT02217904|144396670|SUPERIORITY||Posterior mean difference|-1.28|||||||||||||Posterior Probability (PP) of true mean difference in the plasma HIV-1 RNA change from baseline between islatravir and placebo at least 0.5 log10 copies/mL was \>99%.|Adjusted by Placebo data pooled from historical placebo data from recent monotherapy studies in HIV-1 infected participants (NCT00100048, NCT01466985, NCT01152255, and NCT01353898) and fitted with a longitudinal data analysis (LDA) model containing fixed effects for study and time, and a random effect for participants. LS mean of pooled historical placebo data was -0.03 log10 copies/mL (95% CI -014, 0.09) change from baseline at 168 hours post dose.||||
72441576|NCT02217904|144396670|SUPERIORITY||Posterior mean difference|-1.18|||||||||||||Posterior Probability (PP) of true mean difference in the plasma HIV-1 RNA change from baseline between islatravir and placebo at least 0.5 log10 copies/mL was \>99%.|Adjusted by Placebo data pooled from historical placebo data from recent monotherapy studies in HIV-1 infected participants (NCT00100048, NCT01466985, NCT01152255, and NCT01353898) and fitted with a longitudinal data analysis (LDA) model containing fixed effects for study and time, and a random effect for participants. LS mean of pooled historical placebo data was -0.03 log10 copies/mL (95% CI -014, 0.09) change from baseline at 168 hours post dose.||||
72441577|NCT05930782|144396681|EQUIVALENCE|The treatment was considered as bioequivalent if the 90% confidence interval (CI) for geometric least square mean ratios (GMR) of Cmax falls within the acceptance range of 80.00 % to 125.00 %.|geometric least square mean ratios (GMR)|73.9|||||TWO_SIDED|90.0|48.32|113.02||||||||113.02|48.32|
72559299|NCT02420353|144648237|OTHER|mixed effects model||||||0.6288|||||||Mixed Models Analysis|||||||0.6288
72559300|NCT02420353|144648238|OTHER|mixed effects model||||||0.5022|||||||Mixed Models Analysis|||||||0.5022
72559301|NCT02420353|144648239|OTHER|mixed effects model||||||0.7507|||||||Mixed Models Analysis|||||||0.7507
72559302|NCT02420353|144648240|OTHER|mixed effects model|||||<|0.0001|||||||Mixed Models Analysis|||||||<.0001
72559303|NCT02420353|144648241|OTHER|mixed effects model||||||0.8581|||||||Mixed Models Analysis|||||||0.8581
72559304|NCT02420353|144648242|OTHER|mixed effects model||||||0.0208|||||||Mixed Models Analysis|||||||0.0208
72559305|NCT02420353|144648243|OTHER|Mixed effects model||||||0.8581|||||||Mixed Models Analysis|||||||0.8581
72441578|NCT05930782|144396682|EQUIVALENCE|The treatment was considered as bioequivalent if the 90% confidence interval (CI) for geometric least square mean ratios (GMR) of ln-transformed parameters falls within the acceptance range of 80.00 % to 125.00 %.|geometric least square mean ratio (GMR)|75.41|||||TWO_SIDED|90.0|56.46|100.71||||||||100.71|56.46|
72441579|NCT05930782|144396683|EQUIVALENCE|The treatment was considered as bioequivalent if the 90% confidence interval (CI) for geometric least square mean ratios (GMR) of ln-transformed parameters falls within the acceptance range of 80.00 % to 125.00 %.|geometric least square mean ratios (GMR)|86.45|||||TWO_SIDED|90.0|68.16|109.63||||||||109.63|68.16|
72441580|NCT05930782|144396684|EQUIVALENCE|The treatment was considered as bioequivalent if the 90% confidence interval (CI) for geometric least square mean ratios (GMR) of ln-transformed parameters falls within the acceptance range of 80.00 % to 125.00 %.|geometric least square mean ratios (GMR)|77.67|||||TWO_SIDED|90.0|59.49|101.39||||||||101.39|59.49|
72441581|NCT05930782|144396685|EQUIVALENCE|The treatment was considered as bioequivalent if the 90% confidence interval (CI) for geometric least square mean ratios (GMR) of ln-transformed parameters falls within the acceptance range of 80.00 % to 125.00 %.|geometric least square mean ratios (GMR)|55.24|||||TWO_SIDED|90.0|6.03|113.02|||||For AUC0-inf, the GMR and 90% CI values were unreliable as there was only 1 calculable value for the Test (Group 2) and 2 values for the Reference (Group 1) products.|||113.02|6.03|
72441582|NCT04928001|144396693|SUPERIORITY||Mean Difference (Final Values)|31.0||||0.01|TWO_SIDED|95.0|0.0|60.0|||t-test, 1 sided|||||60|0|.01
72496204|NCT04426695|144522390|SUPERIORITY|||||||0.0092||||||P-value was derived CMH test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< = 5 or n(1-p) \<= 5 in any treatment group, p-value was based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.0092
72496205|NCT04426695|144522390|SUPERIORITY|||||||0.221||||||P-value was derived CMH test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< = 5 or n(1-p) \<= 5 in any treatment group, p-value was based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.2210
72496206|NCT04426695|144522390|SUPERIORITY|||||||0.0249||||||P-value was derived CMH test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< = 5 or n(1-p) \<= 5 in any treatment group, p-value was based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||To control alpha at a strict 0.05 level, this endpoint was tested hierarchically, with the virologic endpoint tested first. All hierarchical testing was done using the combined dose group.||||0.0249
72496207|NCT04426695|144522391|SUPERIORITY|||||||0.0045||||||P-value was derived CMH test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< = 5 or n(1-p) \<= 5 in any treatment group, p-value was based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.0045
72496208|NCT04426695|144522391|SUPERIORITY|||||||0.0714||||||P-value was derived CMH test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< = 5 or n(1-p) \<= 5 in any treatment group, p-value was based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.0714
72496209|NCT04426695|144522391|SUPERIORITY|||||||0.0061||||||P-value was derived CMH test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< = 5 or n(1-p) \<= 5 in any treatment group, p-value was based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||To control alpha at a strict 0.05 level, this endpoint was tested hierarchically, with the virologic endpoint tested first. All hierarchical testing was done using the combined dose group.||||0.0061
72441583|NCT01693120|144396694|SUPERIORITY||rate|1.6||||0.175|ONE_SIDED|95.0||4.9|||exact binomial test|||The null hypothesis was that the procedure or device related stroke rate within 30-days of a Phased RF ablation procedure was 3.5% or greater. The alternative hypothesis was that this rate was less than 3.5%. A sample size of 300 subjects provided 90% power to test the null hypothesis assuming the true stroke rate was 1.0% with a one-sided type I error rate of 0.05||4.9||0.175
72441584|NCT01693120|144396695|OTHER|The goal of the analysis was to compute a two-sided 95% confidence interval around the 6-month effectiveness rate. There was no pre-specified hypothesis.|rate|52.6|||||TWO_SIDED|95.0|43.1|62.1||||||||62.1|43.1|
72441585|NCT01693120|144396696|OTHER|There was no prespecified hypothesis tested.|rate|90.7|||||TWO_SIDED|95.0|84.3|95.1||||||There was no prespecified hypothesis tested.||95.1|84.3|
72496210|NCT04426695|144522392|SUPERIORITY|||||||0.0023||||||P-value was derived CMH test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< = 5 or n(1-p) \<= 5 in any treatment group, p-value was based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.0023
72496211|NCT04426695|144522392|SUPERIORITY|||||||0.3544||||||P-value was derived CMH test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< = 5 or n(1-p) \<= 5 in any treatment group, p-value was based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.3544
72496212|NCT04426695|144522392|SUPERIORITY|||||||0.0212||||||P-value was derived CMH test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< = 5 or n(1-p) \<= 5 in any treatment group, p-value was based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||To control alpha at a strict 0.05 level, this endpoint was tested hierarchically, with the virologic endpoint tested first. All hierarchical testing was done using the combined dose group.||||0.0212
72441586|NCT01693120|144396697|OTHER|There was no pre-specified hypothesis to test|rate|0.0|||||TWO_SIDED|95.0|0.0|6.1||||||There was no pre-specified hypothesis to test||6.1|0|
72441587|NCT03050814|144396721|OTHER||Hazard Ratio (HR)|1.061||||0.91|TWO_SIDED|95.0|0.38|2.966|||Kaplan Meier|Kaplan-Meier curves and a two-tailed log-rank test||||2.966|0.380|0.91
72496213|NCT04426695|144522398|SUPERIORITY|||||||0.0575||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.0575
72496214|NCT04426695|144522398|SUPERIORITY|||||||0.3133||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.3133
72496215|NCT04426695|144522398|SUPERIORITY|||||||0.0849||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.0849
72441588|NCT05119855|144396748|OTHER|Geometric Mean Titer (GMT) Ratio with corresponding 2-sided 95% confidence interval (CI) was calculated using an analysis of variance model (ANOVA) with a response of log individual anti-HPV titers and a fixed effect for the vaccination groups, Concomitant Group versus Non-concomitant Group. GMT Ratio is reported for Concomitant Group/Non-concomitant Group.|Geometric Mean Titer (GMT) Ratio|1.22|||||TWO_SIDED|95.0|0.92|1.61|||||GMT Ratio is between Concomitant Group/Non-concomitant Group.|Anti-HPV 6||1.61|0.92|
72441589|NCT05119855|144396748|OTHER|Geometric Mean Titer (GMT) Ratio with corresponding 2-sided 95% confidence interval (CI) was calculated using an analysis of variance model (ANOVA) with a response of log individual anti-HPV titers and a fixed effect for the vaccination groups, Concomitant Group versus Non-Concomitant Group. GMT Ratio is between Concomitant Group/Non-concomitant Group.|Geometric Mean Titer (GMT) Ratio|1.33|||||TWO_SIDED|95.0|1.01|1.75|||||GMT Ratio is between Concomitant Group/Non-concomitant Group.|Anti-HPV 11||1.75|1.01|
72441590|NCT05119855|144396748|OTHER|Geometric Mean Titer (GMT) Ratio with corresponding 2-sided 95% confidence interval (CI) was calculated using an analysis of variance model (ANOVA) with a response of log individual anti-HPV titers and a fixed effect for the vaccination groups, Concomitant Group versus Non-Concomitant Group. GMT Ratio is between Concomitant Group/Non-concomitant Group.|Geometric Mean Titer (GMT) Ratio|1.36|||||TWO_SIDED|95.0|1.02|1.82|||||GMT Ratio is between Concomitant Group/Non-concomitant Group.|Anti-HPV 16||1.82|1.02|
72441591|NCT05119855|144396748|OTHER|Geometric Mean Titer (GMT) Ratio with corresponding 2-sided 95% confidence interval (CI) was calculated using an analysis of variance model (ANOVA) with a response of log individual anti-HPV titers and a fixed effect for the vaccination groups, Concomitant Group versus Non-Concomitant Group. Group. GMT Ratio is between Concomitant Group/Non-concomitant Group.|Geometric Mean Titer (GMT) Ratio|1.25|||||TWO_SIDED|95.0|0.92|1.7|||||GMT Ratio is between Concomitant Group/Non-concomitant Group.|Anti-HPV 18||1.70|0.92|
72441592|NCT05119855|144396748|OTHER|Geometric Mean Titer (GMT) Ratio with corresponding 2-sided 95% confidence interval (CI) was calculated using an analysis of variance model (ANOVA) with a response of log individual anti-HPV titers and a fixed effect for the vaccination groups, Concomitant Group versus Non-Concomitant Group. Group. GMT Ratio is between Concomitant Group/Non-concomitant Group.|Geometric Mean Titer (GMT) Ratio|1.21|||||TWO_SIDED|95.0|0.91|1.61|||||GMT Ratio is between Concomitant Group/Non-concomitant Group.|Anti-HPV 31||1.61|0.91|
72441593|NCT05119855|144396748|OTHER|Geometric Mean Titer (GMT) Ratio with corresponding 2-sided 95% confidence interval (CI) was calculated using an analysis of variance model (ANOVA) with a response of log individual anti-HPV titers and a fixed effect for the vaccination groups, Concomitant Group versus Non-Concomitant Group. GMT Ratio is between Concomitant Group/Non-concomitant Group.|Geometric Mean Titer (GMT) Ratio|1.32|||||TWO_SIDED|95.0|0.98|1.77|||||GMT Ratio is between Concomitant Group/Non-concomitant Group.|Anti-HPV 33||1.77|0.98|
72441594|NCT05119855|144396748|OTHER|Geometric Mean Titer (GMT) Ratio with corresponding 2-sided 95% confidence interval (CI) was calculated using an analysis of variance model (ANOVA) with a response of log individual anti-HPV titers and a fixed effect for the vaccination groups, Concomitant Group versus Non-Concomitant Group. GMT Ratio is between Concomitant Group/Non-concomitant Group.|Geometric Mean Titer (GMT) Ratio|1.4|||||TWO_SIDED|95.0|1.01|1.93|||||GMT Ratio is between Concomitant Group/Non-concomitant Group.|Anti-HPV 45||1.93|1.01|
72441595|NCT05119855|144396748|OTHER|Geometric Mean Titer (GMT) Ratio with corresponding 2-sided 95% confidence interval (CI) was calculated using an analysis of variance model (ANOVA) with a response of log individual anti-HPV titers and a fixed effect for the vaccination groups, Concomitant Group versus Non-Concomitant Group. GMT Ratio is between Concomitant Group/Non-concomitant Group.|Geometric Mean Titer (GMT) Ratio|1.45|||||TWO_SIDED|95.0|1.13|1.87|||||GMT Ratio is between Concomitant Group/Non-concomitant Group.|Anti-HPV 52||1.87|1.13|
72496216|NCT04426695|144522399|SUPERIORITY|||||||0.2167||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.2167
72496217|NCT04426695|144522399|SUPERIORITY|||||||0.4123||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.4123
72441596|NCT05119855|144396748|OTHER|Geometric Mean Titer (GMT) Ratio with corresponding 2-sided 95% confidence interval (CI) was calculated using an analysis of variance model (ANOVA) with a response of log individual anti-HPV titers and a fixed effect for the vaccination groups, Concomitant Group versus Non-Concomitant Group. GMT Ratio is between Concomitant Group/Non-concomitant Group.|Geometric Mean Titer (GMT) Ratio|1.2|||||TWO_SIDED|95.0|0.91|1.58|||||GMT Ratio is between Concomitant Group/Non-concomitant Group.|Anti-HPV 58||1.58|0.91|
72441597|NCT05119855|144396749|OTHER|Geometric Mean Concentration (GMC) Ratio with corresponding 2-sided 95% confidence interval (CI) was calculated using an analysis of variance model (ANOVA) with a response of log individual anti-SARS-CoV-2 concentrations and a fixed effect for the vaccination groups, Concomitant Group versus Non-Concomitant Group. GMC Ratio is between Concomitant Group/Non-concomitant Group.|Geometric Mean Concentration (GMC) Ratio|1.17|||||TWO_SIDED|95.0|0.99|1.4|||||GMC Ratio is between Concomitant Group/Non-concomitant Group.|Geometric Mean Concentration (GMC) Ratio||1.40|0.99|
72559306|NCT01149057|144648247|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Paired sample T-test|||Analysis was performed using paired sample t-test for change from baseline.||||<0.0001
72559307|NCT01149057|144648248|SUPERIORITY_OR_OTHER|||||||0.3778|TWO_SIDED|||||P value by analysis of covariance (ANCOVA) for the change from baseline, adjusted to number of days between the first and the second DXA test.|ANCOVA|||Comparison of L1-L4 T-scores||||0.3778
72496218|NCT04426695|144522399|SUPERIORITY|||||||0.2206||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.2206
72441598|NCT00567489|144396781|SUPERIORITY||Mean Difference (Final Values)|0.6|||<|0.001|TWO_SIDED|95.0|0.2|0.9|||ANOVA|||Month 3||0.9|0.2|<0.001
72441599|NCT00567489|144396781|SUPERIORITY||Mean Difference (Final Values)|0.5||||0.006|TWO_SIDED|95.0|0.1|0.8|||ANOVA|||Month 6||0.8|0.1|0.006
72441600|NCT00567489|144396782|SUPERIORITY||Mean Difference (Final Values)|5.0||||0.312|TWO_SIDED|95.0|-4.7|14.7|||ANOVA|||Insulin-Month 3||14.7|-4.7|0.312
72441601|NCT00567489|144396782|SUPERIORITY||Mean Difference (Final Values)|4.7||||0.342|TWO_SIDED|95.0|-5.0|14.4|||ANOVA|||Insulin-Month 6||14.4|-5.0|0.342
72441602|NCT00567489|144396784|SUPERIORITY||Mean Difference (Final Values)|0.5||||0.01|TWO_SIDED|95.0|0.1|0.9|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Cholesterol-Month 3||0.9|0.1|0.010
72441603|NCT00567489|144396784|SUPERIORITY||Median Difference (Final Values)|0.3||||0.073|TWO_SIDED|95.0|0.0|0.7|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Cholesterol-Month 6||0.7|0|0.073
72441604|NCT00567489|144396784|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.181|TWO_SIDED|95.0|-0.1|0.5|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for LDLC-Month 3||0.5|-0.1|0.181
72441605|NCT00567489|144396784|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.593|TWO_SIDED|95.0|-0.2|0.4|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for LDLC-Month 6||0.4|-0.2|0.593
72441606|NCT00567489|144396784|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.198|TWO_SIDED|95.0|-0.2|0.0|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for HDLC-Month 3||0|-0.2|0.198
72441607|NCT00567489|144396784|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.298|TWO_SIDED|95.0|-0.1|0.0|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for HDLC-Month 6||0|-0.1|0.298
72441608|NCT00567489|144396784|SUPERIORITY||Mean Difference (Final Values)|0.4|||<|0.001|TWO_SIDED|95.0|0.2|0.6|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for VLDL-Month 3||0.6|0.2|<0.001
72441609|NCT00567489|144396784|SUPERIORITY||Mean Difference (Final Values)|0.3||||0.003|TWO_SIDED|95.0|0.1|0.5|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for VLDL-Month 6||0.5|0.1|0.003
72441610|NCT00567489|144396784|SUPERIORITY||Mean Difference (Final Values)|0.8|||<|0.001|TWO_SIDED|95.0|0.4|1.3|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Triglycerides-Month 3||1.3|0.4|<0.001
72441611|NCT00567489|144396784|SUPERIORITY||Mean Difference (Final Values)|0.7||||0.002|TWO_SIDED|95.0|0.3|1.1|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Triglycerides-Month 6||1.1|0.3|0.002
72441612|NCT00567489|144396785|SUPERIORITY||Mean Difference (Final Values)|-2.3||||0.485|TWO_SIDED|95.0|-8.6|4.1|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Lp(a)-Month 3||4.1|-8.6|0.485
72441613|NCT00567489|144396785|SUPERIORITY||Mean Difference (Final Values)|-1.9||||0.556|TWO_SIDED|95.0|-8.2|4.4|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Lp(a)-Month 6||4.4|-8.2|0.556
72441614|NCT00567489|144396785|SUPERIORITY||Mean Difference (Final Values)|5.6||||0.101|TWO_SIDED|95.0|-1.1|12.2|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Apo A1-Month 3||12.2|-1.1|0.101
72441615|NCT00567489|144396785|SUPERIORITY||Mean Difference (Final Values)|5.0||||0.134|TWO_SIDED|95.0|-1.5|11.5|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Apo A1-Month 6||11.5|-1.5|0.134
72441616|NCT00567489|144396785|SUPERIORITY||Mean Difference (Final Values)|11.4||||0.004|TWO_SIDED|95.0|3.6|19.2|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Apo B-Month 3||19.2|3.6|0.004
72441617|NCT00567489|144396785|SUPERIORITY||Mean Difference (Final Values)|8.4||||0.03|TWO_SIDED|95.0|0.8|15.9|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Apo B-Month 6||15.9|0.8|0.030
72441618|NCT00567489|144396786|SUPERIORITY||Mean Difference (Final Values)|-56.5||||0.655|TWO_SIDED|95.0|-304.6|191.7|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Insulin-Month 3||191.7|-304.6|0.655
72441619|NCT00567489|144396786|SUPERIORITY||Mean Difference (Final Values)|-29.2||||0.811|TWO_SIDED|95.0|-268.9|210.5|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Insulin-Month 6||210.5|-268.9|0.811
72441620|NCT00567489|144396786|SUPERIORITY||Mean Difference (Final Values)|441.3||||0.419|TWO_SIDED|95.0|-630.4|1513.1|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for C-Peptide-Month 3||1513.1|-630.4|0.419
72441621|NCT00567489|144396786|SUPERIORITY||Mean Difference (Final Values)|121.8||||0.82|TWO_SIDED|95.0|-927.9|1171.5|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for C-Peptide-Month 6||1171.5|-927.9|0.820
72441622|NCT00567489|144396787|SUPERIORITY||Mean Difference (Final Values)|-4.2||||0.721|TWO_SIDED|95.0|-27.5|19.0|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Pro-Insulin-Month 3||19|-27.5|0.721
72441623|NCT00567489|144396787|SUPERIORITY||Mean Difference (Final Values)|13.5||||0.247|TWO_SIDED|95.0|-9.4|36.4|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Pro-Insulin-Month 6||36.4|-9.4|0.247
72441624|NCT00567489|144396788|SUPERIORITY||Mean Difference (Final Values)|0.89||||0.624|TWO_SIDED|95.0|0.55|1.43|||ANOVA|||Estimates of Ratio-Month 6||1.43|0.55|0.624
72441625|NCT00567489|144396789|SUPERIORITY||Mean Difference (Final Values)|0.6||||0.338|TWO_SIDED|95.0|-0.6|1.8|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Albumin-Month 3||1.8|-0.6|0.338
72441626|NCT00567489|144396789|SUPERIORITY||Mean Difference (Final Values)|1.3||||0.029|TWO_SIDED|95.0|0.1|2.5|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Albumin-Month 6||2.5|0.1|0.029
72441627|NCT00567489|144396789|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.817|TWO_SIDED|95.0|-1.9|1.5|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Total Protein-Month 3||1.5|-1.9|0.817
72441628|NCT00567489|144396789|SUPERIORITY||Mean Difference (Final Values)|1.4||||0.091|TWO_SIDED|95.0|-0.2|2.9|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Total Protein-Month 6||2.9|-0.2|0.091
72441629|NCT00567489|144396790|SUPERIORITY||Mean Difference (Final Values)|-10.2||||0.127|TWO_SIDED|95.0|-23.3|2.9|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for PNA-Month 3||2.9|-23.3|0.127
72441630|NCT00567489|144396790|SUPERIORITY||Mean Difference (Final Values)|-10.3|||<|0.001|TWO_SIDED|95.0|-16.4|-4.3|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for PNA-Month 6||-4.3|-16.4|<0.001
72441631|NCT00567489|144396790|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.012|TWO_SIDED|95.0|-0.4|-0.1|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for nPNA-Month 3||-0.1|-0.4|0.012
72441632|NCT00567489|144396790|SUPERIORITY||Mean Difference (Final Values)|-0.2|||<|0.001|TWO_SIDED|95.0|-0.3|-0.1|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for nPNA-Month 6||-0.1|-0.3|<0.001
72441633|NCT00567489|144396791|SUPERIORITY||Mean Difference (Final Values)|3.2||||0.019|TWO_SIDED|95.0|0.5|5.8|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Pre-Albumin-Month 3||5.8|0.5|0.019
72441634|NCT00567489|144396791|SUPERIORITY||Mean Difference (Final Values)|3.0||||0.019|TWO_SIDED|95.0|0.5|5.6|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Pre-Albumin-Month 6||5.6|0.5|0.019
72441635|NCT00567489|144396792|SUPERIORITY||Mean Difference (Final Values)|-0.3||||0.884|TWO_SIDED|95.0|-3.9|3.4|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Drained Fat-Month 3||3.4|-3.9|0.884
72441636|NCT00567489|144396792|SUPERIORITY||Mean Difference (Final Values)|0.7||||0.716|TWO_SIDED|95.0|-3.0|4.3|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Drained Fat-Month 6||4.3|-3|0.716
72441637|NCT00567489|144396793|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.961|TWO_SIDED|95.0|-1.2|1.1|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for BMI-Month 3||1.1|-1.2|0.961
72441638|NCT00567489|144396793|SUPERIORITY||Mean Difference (Final Values)|0.3||||0.581|TWO_SIDED|95.0|-0.8|1.5|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for BMI-Month 6||1.5|-0.8|0.581
72496219|NCT04426695|144522400|SUPERIORITY|||||||0.0383||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.0383
72496220|NCT04426695|144522400|SUPERIORITY|||||||0.3296||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.3296
72496221|NCT04426695|144522400|SUPERIORITY|||||||0.0766||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.0766
72496222|NCT04426695|144522401|SUPERIORITY|||||||0.007||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.0070
72496223|NCT04426695|144522401|SUPERIORITY|||||||0.0507||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.0507
72441639|NCT00567489|144396794|SUPERIORITY||Mean Difference (Final Values)|-0.3||||0.871|TWO_SIDED|95.0|-3.7|3.1|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Waist Circumference-Month 6||3.1|-3.7|0.871
72441640|NCT00567489|144396795|SUPERIORITY||Mean Difference (Final Values)|5.2||||0.608|TWO_SIDED|95.0|-14.7|25.0|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Protein-Month 3||25|-14.7|0.608
72441641|NCT00567489|144396795|SUPERIORITY||Mean Difference (Final Values)|-1.7||||0.731|TWO_SIDED|95.0|-11.5|8.1|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Protein-Month 6||8.1|-11.5|0.731
72441642|NCT00567489|144396795|SUPERIORITY||Mean Difference (Final Values)|185.3||||0.377|TWO_SIDED|95.0|-227.5|598.1|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Calories-Month 3||598.1|-227.5|0.377
72441643|NCT00567489|144396795|SUPERIORITY||Mean Difference (Final Values)|-18.3||||0.854|TWO_SIDED|95.0|-214.4|177.8|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Calories-Month 6||177.8|-214.4|0.854
72441644|NCT00567489|144396796|SUPERIORITY||Mean Difference (Final Values)|0.02||||0.412|TWO_SIDED|95.0|-0.03|0.07|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for EQ 5D Questionnaire Index-Month 3||0.07|-0.03|0.412
72441645|NCT00567489|144396796|SUPERIORITY||Mean Difference (Final Values)|-0.02||||0.485|TWO_SIDED|95.0|-0.07|0.03|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for EQ 5D Questionnaire Index-Month 6||0.03|-0.07|0.485
72441646|NCT00567489|144396797|SUPERIORITY||Mean Difference (Final Values)|2.18||||0.525|TWO_SIDED|95.0|-4.56|8.93|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for EQ 5D Quest Health Status-Month 3||8.93|-4.56|0.525
72441647|NCT00567489|144396797|SUPERIORITY||Mean Difference (Final Values)|0.02||||0.995|TWO_SIDED|95.0|-6.79|6.83|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for EQ 5D Quest Health Status-Month 6||6.83|-6.79|0.995
72441648|NCT00567489|144396798|SUPERIORITY||Mean Difference (Final Values)|-1.87||||0.526|TWO_SIDED|95.0|-7.64|3.91|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Psychology Fatigue-Month 3||3.91|-7.64|0.526
72441649|NCT00567489|144396798|SUPERIORITY||Mean Difference (Final Values)|0.83||||0.779|TWO_SIDED|95.0|-5.01|6.68|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Psychology Fatigue-Month 6||6.68|-5.01|0.779
72441650|NCT00567489|144396798|SUPERIORITY||Mean Difference (Final Values)|-2.95||||0.246|TWO_SIDED|95.0|-7.95|2.04|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Psychology Cognitive-Month 3||2.04|-7.95|0.246
72496224|NCT04426695|144522401|SUPERIORITY|||||||0.0051||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.0051
72441651|NCT00567489|144396798|SUPERIORITY||Mean Difference (Final Values)|-0.72||||0.78|TWO_SIDED|95.0|-5.78|4.34|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Psychology Cognitive-Month 6||4.34|-5.78|0.780
72441652|NCT00567489|144396798|SUPERIORITY||Mean Difference (Final Values)|0.41||||0.885|TWO_SIDED|95.0|-5.22|6.04|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Neurology Pain-Month 3||6.04|-5.22|0.885
72441653|NCT00567489|144396798|SUPERIORITY||Mean Difference (Final Values)|4.41||||0.128|TWO_SIDED|95.0|-1.28|10.1|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Neurology Pain-Month 6||10.10|-1.28|0.128
72441654|NCT00567489|144396798|SUPERIORITY||Mean Difference (Final Values)|1.07||||0.701|TWO_SIDED|95.0|-4.4|6.54|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Neurology Sensory-Month 3||6.54|-4.40|0.701
72441655|NCT00567489|144396798|SUPERIORITY||Mean Difference (Final Values)|7.21||||0.01|TWO_SIDED|95.0|1.7|12.73|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Neurology Sensory-Month 6||12.73|1.70|0.010
72441656|NCT00567489|144396798|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.934|TWO_SIDED|95.0|-4.63|5.03|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Cardiology-Month 3||5.03|-4.63|0.934
72441657|NCT00567489|144396798|SUPERIORITY||Mean Difference (Final Values)|3.13||||0.209|TWO_SIDED|95.0|-1.75|8.01|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Cardiology-Month 6||8.01|-1.75|0.209
72441658|NCT00567489|144396798|SUPERIORITY||Mean Difference (Final Values)|1.89||||0.585|TWO_SIDED|95.0|-4.9|8.68|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Ophthalmology-Month 3||8.68|-4.90|0.585
72441659|NCT00567489|144396798|SUPERIORITY||Mean Difference (Final Values)|1.62||||0.641|TWO_SIDED|95.0|-5.22|8.47|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Ophthalmology-Month 6||8.47|-5.22|0.641
72441660|NCT00567489|144396798|SUPERIORITY||Mean Difference (Final Values)|-1.5||||0.586|TWO_SIDED|95.0|-6.89|3.9|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Hypoglycemia-Month 3||3.90|-6.89|0.586
72441661|NCT00567489|144396798|SUPERIORITY||Mean Difference (Final Values)|-0.33||||0.906|TWO_SIDED|95.0|-5.79|5.14|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Hypoglycemia-Month 6||5.14|-5.79|0.906
72441662|NCT00567489|144396798|SUPERIORITY||Mean Difference (Final Values)|-0.09||||0.97|TWO_SIDED|95.0|-4.93|4.75|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Hyperglycemia-Month 3||4.75|-4.93|0.970
72441663|NCT00567489|144396798|SUPERIORITY||Mean Difference (Final Values)|2.38||||0.34|TWO_SIDED|95.0|-2.52|7.28|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Hyperglycemia-Month 6||7.28|-2.52|0.340
72441664|NCT00567489|144396799|SUPERIORITY||Mean Difference (Final Values)|24.6||||0.495|TWO_SIDED|95.0|-46.9|96.0|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Abdominal Subcutaneous Fat Volume-Month 6||96|-46.9|0.495
72441665|NCT00567489|144396799|SUPERIORITY||Mean Difference (Final Values)|55.4||||0.081|TWO_SIDED|95.0|-7.0|117.8|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Abdominal Visceral Fat Volume-Month 6||117.8|-7|0.081
72441666|NCT00567489|144396800|SUPERIORITY||Mean Difference (Final Values)|6.3||||0.626|TWO_SIDED|95.0|-19.3|31.9|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for LV End Diastolic Volume-Month 6||31.9|-19.3|0.626
72441667|NCT00567489|144396800|SUPERIORITY||Mean Difference (Final Values)|7.8||||0.486|TWO_SIDED|95.0|-14.5|30.1|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for LV End Systolic Volume-Month 6||30.1|-14.5|0.486
72441668|NCT00567489|144396801|SUPERIORITY||Mean Difference (Final Values)|2.3||||0.832|TWO_SIDED|95.0|-18.9|23.4|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for LV Mass with Pap Muscles-Month 6||23.4|-18.9|0.832
72441669|NCT00567489|144396801|SUPERIORITY||Mean Difference (Final Values)|2.4||||0.82|TWO_SIDED|95.0|-18.3|23.1|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for LV Mass without Pap Muscles-Month 6||23.1|-18.3|0.820
72441670|NCT00567489|144396802|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.955|TWO_SIDED|95.0|-6.9|6.5|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for LV Ejection Fraction-Month 6||6.5|-6.9|0.955
72441671|NCT00780234|144396840|OTHER||Regression model parameter (α1)|-0.4|STANDARD_ERROR_OF_MEAN|0.63||0.53|TWO_SIDED|95.0|-1.68|0.89|||Regression, Linear|The estimates of treatment effect were adjusted for baseline histology values.||"The hypotheses tested were:~H0: α1 = 0 vs H1: α1 \~= 0"|The hypothesis test was a 2-sided t-test of the effect of group (i.e. the difference between the pioglitazone and placebo groups). The general form of the model is Y = α0 + α1GROUP + α2BASELINE. Y represents the 6-month value of the dependent variable (summary of the histology), GROUP represents a classification variable for the treatment group (1=pioglitazone, 2=placebo), BASELINE represents the value of the outcome measure at baseline, and α0, α1 and α2 represent the parameter estimates from the general linear model. The test of the difference between groups will be the formal test of significance of the α1 parameter.|0.89|-1.68|0.53
72441672|NCT00957242|144396841|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.32||||0.27|TWO_SIDED|95.0|0.7|2.47|||Regression, Cox|Prespecified covariates in the model included an indicator variable for the treatment group and the DLCO measurement from the baseline assessment.|Warfarin vs. Placebo|The study was designed to have 90% power to detect a difference in 48-week event free rates of 70% for the warfarin group versus 50% for the placebo group. A total of at least 95 adjudicated primary endpoints were required to achieve 90% power with 2-sided, type I error rate of 0.05 and a 1:1 randomization ratio. These calculations yielded a requisite total sample size of 256.||2.47|0.70|0.27
72441673|NCT00957242|144396842|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|5.03||||0.005|TWO_SIDED|95.0|1.44|17.54|||Cox Proportional|||||17.54|1.44|0.005
72441674|NCT00957242|144396843|SUPERIORITY_OR_OTHER||t-value|0.08||||0.083||95.0|-0.01|0.17|||Mixed Models Analysis|||||0.17|-0.01|0.083
72441675|NCT00957242|144396844|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.06||||0.054|TWO_SIDED|95.0|0.99|4.31|||Cox Proportional|||||4.31|0.99|0.054
72441676|NCT00957242|144396845|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.47||||0.19|TWO_SIDED|95.0|0.64|9.56|||Cox Proportional|||||9.56|0.64|0.19
72441677|NCT00957242|144396846|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.25||||0.35|TWO_SIDED|95.0|0.41|12.34|||Cox Proportional|||||12.34|0.41|0.35
72441678|NCT00957242|144396847|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|3.24||||0.15|TWO_SIDED|95.0|0.65|16.1|||Cox Proportional|||||16.10|0.65|0.15
72441679|NCT00957242|144396848|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.91||||0.88|TWO_SIDED|95.0|0.24|3.39|||Cox Proportional|||||3.39|0.24|0.88
72441680|NCT00957242|144396849|SUPERIORITY_OR_OTHER||t-value|10.88||||0.7222|TWO_SIDED|95.0|-49.57|71.34|||Mixed Models Analysis|||||71.34|-49.57|0.7222
72441681|NCT00957242|144396850|SUPERIORITY_OR_OTHER||t-value|-1.78||||0.27|TWO_SIDED|95.0|-7.04|3048.0|||Mixed Models Analysis|||||3048|-7.04|0.27
72441682|NCT00957242|144396851|SUPERIORITY_OR_OTHER||t-value|0.05||||0.957|TWO_SIDED|95.0|-1.67|1076.0|||Mixed Models Analysis|||||1076|-1.67|0.957
72441683|NCT00957242|144396852|SUPERIORITY_OR_OTHER||t-value|-0.48||||0.009|TWO_SIDED|95.0|-0.84|-0.12|||Mixed Models Analysis|||||-0.12|-0.84|0.009
72441684|NCT01976312|144396853|SUPERIORITY_OR_OTHER||||||<|0.001|ONE_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
72441685|NCT04048382|144396860|SUPERIORITY||Odds Ratio (OR)|1.1||||0.88|TWO_SIDED||||||Regression, Logistic|||||||.88
72441686|NCT04048382|144396861|SUPERIORITY||Odds Ratio (OR)|1.7||||0.49|TWO_SIDED||||||Regression, Logistic|||||||.49
72441687|NCT04048382|144396862|SUPERIORITY||Odds Ratio (OR)|1.1||||0.91|TWO_SIDED||||||Regression, Logistic|||||||.91
72441688|NCT04048382|144396863|SUPERIORITY||Odds Ratio (OR)|1.4||||0.65|TWO_SIDED||||||Regression, Logistic|||||||.65
72441689|NCT04048382|144396864|SUPERIORITY||Odds Ratio (OR)|0.29||||0.17|TWO_SIDED||||||Regression, Logistic|||||||.17
72441690|NCT04048382|144396865|SUPERIORITY||Odds Ratio (OR)|0.29||||0.19|TWO_SIDED||||||Regression, Logistic|||||||.19
72441691|NCT01037985|144396876|SUPERIORITY||Mean Difference (Final Values)|-4.3||||0.168|TWO_SIDED|95.0|-10.4|1.9|||t-test, 2 sided|||Within participant treatment difference was assessed between the treatment regimens each participant received (EXC 001 minus placebo).||1.9|-10.4|0.168
72496225|NCT04426695|144522402|SUPERIORITY|||||||0.0174||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.0174
72441692|NCT01037985|144396877|SUPERIORITY||Mean Difference (Final Values)|0.3||||0.858|TWO_SIDED|95.0|-3.5|4.2|||t-test, 2 sided|||Within participant treatment difference was assessed between the treatment regimens each participant received (EXC 001 minus placebo).||4.2|-3.5|0.858
72441693|NCT01037985|144396878|SUPERIORITY||Mean Difference (Final Values)|-1.0||||0.003|TWO_SIDED|95.0|-1.6|-0.4|||t-test, 2 sided|||Week 12, Vascularity: Comparison within the participant between EXC 001 and placebo.||-0.4|-1.6|0.003
72441694|NCT01037985|144396878|SUPERIORITY||Mean Difference (Final Values)|-0.5||||0.067|TWO_SIDED|95.0|-1.1|0.0|||t-test, 2 sided|||Week 12, Pigmentation: Comparison within the participant between EXC 001 and placebo.||0.0|-1.1|0.067
72441695|NCT01037985|144396878|SUPERIORITY||Mean Difference (Final Values)|-1.4|||<|0.001|TWO_SIDED|95.0|-2.1|-0.7|||t-test, 2 sided|||Week 12, Thickness: Comparison within the participant between EXC 001 and placebo.||-0.7|-2.1|<0.001
72441696|NCT01037985|144396878|SUPERIORITY||Median Difference (Final Values)|-0.9||||0.002|TWO_SIDED|95.0|-1.4|-0.4|||t-test, 2 sided|||Week 12, Relief: Comparison within the participant between EXC 001 and placebo.||-0.4|-1.4|0.002
72441697|NCT01037985|144396878|SUPERIORITY||Mean Difference (Final Values)|-0.8||||0.007|TWO_SIDED|95.0|-1.3|-0.2|||t-test, 2 sided|||Week 12, Pliability: Comparison within the participant between EXC 001 and placebo.||-0.2|-1.3|0.007
72496226|NCT04426695|144522402|SUPERIORITY|||||||0.29||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.2900
72441698|NCT01037985|144396878|SUPERIORITY||Mean Difference (Final Values)|-0.4||||0.214|TWO_SIDED|95.0|-1.1|0.3|||t-test, 2 sided|||Week 12, Surface Area: Comparison within the participant between EXC 001 and placebo.||0.3|-1.1|0.214
72441699|NCT01037985|144396878|SUPERIORITY||Mean Difference (Final Values)|-0.9||||0.003|TWO_SIDED|95.0|-1.5|-0.3|||t-test, 2 sided|||Week 12, Overall Opinion: Comparison within the participant between EXC 001 and placebo.||-0.3|-1.5|0.003
72441700|NCT01037985|144396878|SUPERIORITY||Mean Difference (Final Values)|-5.0|||<|0.001|TWO_SIDED|95.0|-7.8|-2.2|||t-test, 2 sided|||Week 12, Composite Score: Comparison within the participant between EXC 001 and placebo.||-2.2|-7.8|<0.001
72441701|NCT01037985|144396878|SUPERIORITY||Mean Difference (Net)|0.1||||0.673|TWO_SIDED|95.0|-0.5|0.7|||t-test, 2 sided|||Week 24, Vascularity: Comparison within the participant between EXC 001 and placebo.||0.7|-0.5|0.673
72441702|NCT01037985|144396878|SUPERIORITY||Mean Difference (Final Values)|0.4||||0.276|TWO_SIDED|95.0|-0.3|1.1|||t-test, 2 sided|||Week 24, Pigmentation: Comparison within the participant between EXC 001 and placebo.||1.1|-0.3|0.276
72441703|NCT01037985|144396878|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.67|TWO_SIDED|95.0|-0.7|0.5|||t-test, 2 sided|||Week 24, Thickness: Comparison within the participant between EXC 001 and placebo.||0.5|-0.7|0.670
72441704|NCT01037985|144396878|SUPERIORITY||Mean Difference (Final Values)|0.0||||1|TWO_SIDED|95.0|-0.5|0.5|||t-test, 2 sided|||Week 24, Relief: Comparison within the participant between EXC 001 and placebo.||0.5|-0.5|1.000
72441705|NCT01037985|144396878|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.909|TWO_SIDED|95.0|-0.5|0.6|||t-test, 2 sided|||Week 24, Pliability: Comparison within the participant between EXC 001 and placebo.||0.6|-0.5|0.909
72441706|NCT01037985|144396878|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.852|TWO_SIDED|95.0|-0.6|0.8|||t-test, 2 sided|||Week 24, Surface Area: Comparison within the participant between EXC 001 and placebo.||0.8|-0.6|0.852
72441707|NCT01037985|144396878|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.906|TWO_SIDED|95.0|-0.5|0.6|||t-test, 2 sided|||Week 24, Overall Opinion: Comparison within the participant between EXC 001 and placebo.||0.6|-0.5|0.906
72441708|NCT01037985|144396878|SUPERIORITY||Mean Difference (Final Values)|0.5||||0.768|TWO_SIDED|95.0|-2.8|3.8|||t-test, 2 sided|||Week 24, Composite Score: Comparison within the participant between EXC 001 and placebo.||3.8|-2.8|0.768
72441709|NCT01037985|144396879|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.773|TWO_SIDED|95.0|-0.4|0.5|||t-test, 2 sided|||Week 12 Pain: Comparison within the participant between EXC 001 and placebo.||0.5|-0.4|0.773
72441710|NCT01037985|144396879|SUPERIORITY||Mean Difference (Final Values)|0.0||||1|TWO_SIDED|95.0|-0.4|0.4|||t-test, 2 sided|||Week 12, Itching: Comparison within the participant between EXC 001 and placebo.||0.4|-0.4|1.000
72441711|NCT01037985|144396879|SUPERIORITY||Mean Difference (Final Values)|-0.7||||0.072|TWO_SIDED|95.0|-1.4|0.1|||t-test, 2 sided|||Week 12, Color: Comparison within the participant between EXC 001 and placebo.||0.1|-1.4|0.072
72441712|NCT01037985|144396879|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.851|TWO_SIDED|95.0|-0.7|0.6|||t-test, 2 sided|||Week 12, Stiffness: Comparison within the participant between EXC 001 and placebo.||0.6|-0.7|0.851
72441713|NCT01037985|144396879|SUPERIORITY||Mean Difference (Final Values)|-0.5||||0.184|TWO_SIDED|95.0|-1.2|0.2|||t-test, 2 sided|||Week 12, Thickness: Comparison within the participant between EXC 001 and placebo.||0.2|-1.2|0.184
72441714|NCT01037985|144396879|SUPERIORITY||Mean Difference (Final Values)|-0.7||||0.059|TWO_SIDED|95.0|-1.3|0.0|||t-test, 2 sided|||Week 12, Irregular: Comparison within the participant between EXC 001 and placebo.||0.0|-1.3|0.059
72441715|NCT01037985|144396879|SUPERIORITY||Mean Difference (Final Values)|-0.8||||0.04|TWO_SIDED|95.0|-1.5|0.0|||t-test, 2 sided|||Week 12, Overall Opinion: Comparison within the participant between EXC 001 and placebo.||-0.0|-1.5|0.040
72441716|NCT01037985|144396879|SUPERIORITY||Mean Difference (Final Values)|-1.8||||0.12|TWO_SIDED|95.0|-4.1|0.5|||t-test, 2 sided|||Week 12, Composite Score: Comparison within the participant between EXC 001 and placebo.||0.5|-4.1|0.120
72441717|NCT01037985|144396879|SUPERIORITY||Mean Difference (Final Values)|-1.8||||0.094|TWO_SIDED|95.0|-4.0|0.3|||t-test, 2 sided|||Week 12, Scar Appearance Composite Score: Comparison within the participant between EXC 001 and placebo.||0.3|-4.0|0.094
72441718|NCT01037985|144396879|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.243|TWO_SIDED|95.0|-0.2|0.6|||t-test, 1 sided|||Week 24, Pain: Comparison within the participant between EXC 001 and placebo.||0.6|-0.2|0.243
72441719|NCT01037985|144396879|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.339|TWO_SIDED|95.0|-0.2|0.6|||t-test, 2 sided|||Week 24, Itching: Comparison within the participant between EXC 001 and placebo.||0.6|-0.2|0.339
72441720|NCT01037985|144396879|SUPERIORITY||Mean Difference (Final Values)|0.5||||0.25|TWO_SIDED|95.0|-0.3|1.2|||t-test, 2 sided|||Week 24, Color: Comparison within the participant between EXC 001 and placebo.||1.2|-0.3|0.250
72441721|NCT01037985|144396879|SUPERIORITY||Mean Difference (Final Values)|-0.5||||0.164|TWO_SIDED|95.0|-1.3|0.2|||t-test, 2 sided|||Week 24, Stiffness: Comparison within the participant between EXC 001 and placebo.||0.2|-1.3|0.164
72441722|NCT01037985|144396879|SUPERIORITY||Mean Difference (Final Values)|0.0||||1|TWO_SIDED|95.0|-0.8|0.8|||t-test, 2 sided|||Week 24, Thickness: Comparison within the participant between EXC 001 and placebo.||0.8|-0.8|1.000
72441723|NCT01037985|144396879|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.928|TWO_SIDED|95.0|-0.8|0.7|||t-test, 2 sided|||Week 24, Irregular: Comparison within the participant between EXC 001 and placebo.||0.7|-0.8|0.928
72441724|NCT01037985|144396879|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.865|TWO_SIDED|95.0|-0.8|0.7|||t-test, 2 sided|||Week 24, Overall Opinion: Comparison within the participant between EXC 001 and placebo.||0.7|-0.8|0.865
72441725|NCT01037985|144396879|SUPERIORITY||Mean Difference (Final Values)|0.3||||0.804|TWO_SIDED|95.0|-2.3|3.0|||t-test, 2 sided|||Week 24, Composite Score: Comparison within the participant between EXC 001 and placebo.||3.0|-2.3|0.804
72441726|NCT01037985|144396879|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.937|TWO_SIDED|95.0|-2.6|2.4|||t-test, 2 sided|||Week 24, Scar Appearance Composite Score: Comparison within the participant between EXC 001 and placebo.||2.4|-2.6|0.937
72441727|NCT02730871|144396886|SUPERIORITY||Mean Difference (Final Values)|-2.15|STANDARD_ERROR_OF_MEAN|0.342|<|0.001|TWO_SIDED|95.0|-2.8|-1.5|||ANCOVA|||||-1.5|-2.8|<0.001
72441728|NCT02730871|144396887|OTHER||Mean Difference (Final Values)|-2.15|STANDARD_ERROR_OF_MEAN|0.342|<|0.001|TWO_SIDED|95.0|-2.8|-1.5|||ANCOVA|||||-1.5|-2.8|<0.001
72441729|NCT02730871|144396888|OTHER||Mean Difference (Final Values)|-9.98|STANDARD_ERROR_OF_MEAN|1.572|<|0.001|TWO_SIDED|95.0|-13.1|-6.9|||ANCOVA|||||-6.9|-13.1|<0.001
72441730|NCT02730871|144396889|OTHER||Mean Difference (Final Values)|-1.33|STANDARD_ERROR_OF_MEAN|0.576||0.022|TWO_SIDED|95.0|-2.5|-0.2|||Repeated measures model|||Change from Baseline in IOP at 9:00||-0.2|-2.5|0.022
72441731|NCT02730871|144396889|OTHER||Mean Difference (Final Values)|-2.85|STANDARD_ERROR_OF_MEAN|0.506|<|0.001|TWO_SIDED|95.0|-3.9|-1.9|||Repeated measures model|||Change from Baseline in IOP at 11:00||-1.9|-3.9|<0.001
72441732|NCT02730871|144396890|OTHER||Mean Difference (Final Values)|-6.15|STANDARD_ERROR_OF_MEAN|2.567||0.018|TWO_SIDED|95.0|-11.2|-1.1|||Repeated measures model|||Percentage Change from Baseline in IOP at 09:00||-1.1|-11.2|0.018
72441733|NCT02730871|144396890|OTHER||Mean Difference (Final Values)|-13.21|STANDARD_ERROR_OF_MEAN|2.34|<|0.001|TWO_SIDED|95.0|-17.8|-8.6|||Repeated measures model|||Percentage Change from Baseline in IOP at 11:00||-8.6|-17.8|<0.001
72441734|NCT04992390|144396908|SUPERIORITY|Poisson regression was performed with baseline measure and binary arm status included as fixed effect covariates. Various regression models for count data were compared to find the best fitting model. Visual exploratory data and model evaluation showed that the Zero Inflated Negative Binomial (ZINB) regression model provided the best fit and was used as the model for the ITT analysis of the primary outcome.|Incidence Rate Ratio|0.31|||<=|0.001|TWO_SIDED|95.0|0.2|0.48||No multiplicity adjustments were applied as there was only one primary outcome, and secondary outcomes aimed to support the primary analyses. The a priori threshold for statistical significance was 0.05.|Regression, Poisson|||For more information on analysis models see Iyadurai et al 2023, https://doi.org/10.1038/s41398-023-02578-0|See also Iyadurai et al 2023, https://doi.org/10.1038/s41398-023-02578-0|0.48|0.20|<= 0.001
72441735|NCT04992390|144396909|SUPERIORITY|Single level general Poisson regression was used to quantify within arm changes of number of intrusive memories in the delayed intervention arm, comparing pre-intervention (week 4) to post-intervention (week 8).|Incidence Rate Ratio|0.31|||<=|0.001|TWO_SIDED|95.0|0.21|0.45||No multiplicity adjustments were applied as there was only one primary outcome, and secondary outcomes aimed to support the primary analyses. The a priori threshold for statistical significance was 0.05.|Regression, Poisson|Single level general Poisson regression was used to quantify within arm changes of number of intrusive memories pre- to post-intervention.||Within the comparator arm, where participants had delayed access to the intervention (i.e., delayed arm crossover), the number of intrusive memories in week 8 was compared to week 4. For full information about statistical analysis see Iyadurai et al 2023, https://doi.org/10.1038/s41398-023-02578-0|For full results see Iyadurai et al 2023, https://doi.org/10.1038/s41398-023-02578-0|0.45|0.21|<= 0.001
72496227|NCT04426695|144522402|SUPERIORITY|||||||0.0454||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.0454
72496228|NCT04426695|144522403|SUPERIORITY|||||||0.004||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.0040
72496229|NCT04426695|144522403|SUPERIORITY|||||||0.0413||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.0413
72496230|NCT04426695|144522403|SUPERIORITY|||||||0.0032||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.0032
72496231|NCT04426695|144522404|SUPERIORITY|||||||0.0105||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.0105
72496232|NCT04426695|144522404|SUPERIORITY|||||||0.0622||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.0622
72559308|NCT01149057|144648248|SUPERIORITY_OR_OTHER|||||||0.1541|TWO_SIDED|||||P value by ANCOVA for the change from baseline, adjusted to number of days between the first and the second DXA test.|ANCOVA|||Comparison of Total spine T-score||||0.1541
72559309|NCT01149057|144648248|SUPERIORITY_OR_OTHER|||||||0.789|TWO_SIDED|||||P value by ANCOVA for the change from baseline, adjusted to number of days between the first and the second DXA test.|ANCOVA|||Comparison of Total hip - left T-score||||0.7890
72559310|NCT01149057|144648248|SUPERIORITY_OR_OTHER|||||||0.7094|TWO_SIDED|||||P value by ANCOVA for the change from baseline, adjusted to number of days between the first and the second DXA test.|ANCOVA|||Comparison of Femoral neck - left T-scores.||||0.7094
72387691|NCT00945893|144283793|SUPERIORITY_OR_OTHER||rate difference|6.1|||||TWO_SIDED|95.0|-5.6|12.6|||score|||The number of participants who experienced a post-dose seroresponse was compared based on the upper limit of the two-sided 95% exact CIs for the rate difference (Vaccine minus Placebo).||12.6|-5.6|
72387692|NCT00945893|144283794|SUPERIORITY_OR_OTHER||rate difference|9.3|||||TWO_SIDED|95.0|-0.8|16.3|||score|||The number of participants who experienced a post-dose seroresponse was compared based on the upper limit of the limit of the two-sided 95% exact CI for the rate difference (Vaccine minus Placebo).||16.3|-0.8|
72387693|NCT00945893|144283795|NON_INFERIORITY_OR_EQUIVALENCE|Rates of solicited symptoms following each dose (Days 1 to 8 and Days 1 to 15) between the two treatment groups were compared following each dose. Exact two-sided 95% CIs (Chan and Zhang, 1999) on the rate difference (monovalent vaccine minus placebo) were constructed. There were no prespecified equivalence criteria for the secondary analyses.|Rate difference|10.0|||||TWO_SIDED|95.0|-4.1|22.8|||Score|||||22.8|-4.1|
72387694|NCT00945893|144283798|NON_INFERIORITY_OR_EQUIVALENCE|Rates of solicited symptoms following each dose (Days 1 to 8 and Days 1 to 15) between the two treatment groups were compared following each dose. Exact two-sided 95% CIs (Chan and Zhang, 1999) on the rate difference (monovalent vaccine minus placebo) were constructed. There were no prespecified equivalence criteria for the secondary analyses.|Rate difference|0.4|||||TWO_SIDED|95.0|-13.9|14.5|||Score|||||14.5|-13.9|
72387695|NCT00945893|144283801|NON_INFERIORITY_OR_EQUIVALENCE|Rates of solicited symptoms following each dose (Days 1 to 8 and Days 1 to 15) between the two treatment groups were compared following each dose. Exact two-sided 95% CIs (Chan and Zhang, 1999) on the rate difference (monovalent vaccine minus placebo) were constructed. There were no prespecified equivalence criteria for the secondary analyses.|Rate difference|-0.5|||||TWO_SIDED|95.0|-14.7|11.8|||Score|||||11.8|-14.7|
72387696|NCT00945893|144283804|NON_INFERIORITY_OR_EQUIVALENCE|Rates of solicited symptoms following each dose (Days 1 to 8 and Days 1 to 15) between the two treatment groups were compared following each dose. Exact two-sided 95% CIs (Chan and Zhang, 1999) on the rate difference (monovalent vaccine minus placebo) were constructed. There were no prespecified equivalence criteria for the secondary analyses.|Rate difference|2.0|||||TWO_SIDED|95.0|-12.6|14.9|||Score|||||14.9|-12.6|
72387697|NCT00945893|144283813|SUPERIORITY_OR_OTHER||rate difference|5.8|||||TWO_SIDED|95.0|-7.7|13.8|||score|||The number of participants who achieved a post Dose 1 HAI titer greater than or equal to 32 against the H1N1 strain was compared based on the upper limit of the two-sided 95% exact CI for the rate difference (Vaccine minus Placebo).||13.8|-7.7|
72387698|NCT00945893|144283814|SUPERIORITY_OR_OTHER||rate difference|-6.0|||||TWO_SIDED|95.0|-23.5|5.3|||score|||The number of participants who achieved a post Dose 1 HAI titer greater than or equal to 32 against the H1N1 strain was compared based on the upper limit of the two-sided 95% exact CI for the rate difference (Vaccine minus Placebo).||5.3|-23.5|
72387699|NCT00945893|144283815|SUPERIORITY_OR_OTHER||rate difference|2.4|||||TWO_SIDED|95.0|-9.3|10.8|||score|||The number of participants who achieved a post Dose 2 HAI titer greater than or equal to 32 against the H1N1 strain was compared based on the upper limit of the two-sided 95% exact CI for the rate difference (Vaccine minus Placebo).||10.8|-9.3|
72387700|NCT00283400|144283821|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.05|||<|0.05|TWO_SIDED|95.0|0.65|14.1|||Mixed Models Analysis|Post-hoc comparison of outcomes in dosage tier 1 vs dosage tier 2.||||14.1|0.65|<0.05
72387701|NCT01034631|144283825|OTHER|||||||0.6625|||||||Chi-squared|||||||.6625
72387702|NCT01890473|144283834|SUPERIORITY_OR_OTHER||ratio of geometric mean|0.908|||||TWO_SIDED|90.0|0.815|1.01||||||The PK comparability of the two devices was assessed via a linear model for each key PK parameter in log scale (using log (Cmax) without a formal test.||1.01|0.815|
72496233|NCT04426695|144522404|SUPERIORITY|||||||0.0088||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.0088
72559311|NCT01149057|144648254|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Wilcoxon Signed Rank Test|||Change from baseline at Week 24||||<0.0001
72441736|NCT04992390|144396909|SUPERIORITY|Single level general Poisson regression was used to quantify within arm changes of number of intrusive memories in the immediate intervention arm, comparing pre-intervention (run-in/screening week) to post-intervention (week 4).|Incidence Rate Ratio|0.22|||<|0.001|TWO_SIDED|95.0|0.1|0.45||No multiplicity adjustments were applied as there was only one primary outcome, and secondary outcomes aimed to support the primary analyses. The a priori threshold for statistical significance was 0.05.|Regression, Poisson|Single level general Poisson regression was used to quantify within arm changes of number of intrusive memories pre- to post-intervention.||Within the immediate intervention arm, where participants had immediate access to the intervention, the number of intrusive memories in Week 4 was compared to the run-in/screening week. For full information about statistical analysis see Iyadurai et al 2023, https://doi.org/10.1038/s41398-023-02578-0||0.45|0.10|<0.001
72441737|NCT04992390|144396910|SUPERIORITY|Multilevel modelling (MLM) was performed with baseline measure, binary arm status, follow-up time and arm-by-time interaction included as fixed-effect covariates. Individual participant was also included as a level-two analytical unit, to quantify: (a) between-group treatment effect estimates and (b) within-group changes between each follow-up time for secondary outcome measures.|Mean Difference (Final Values)|-2.63|||<=|0.001|TWO_SIDED|95.0|-3.72|-1.54||No multiplicity adjustments were applied as there was only one primary outcome, and secondary outcomes aimed to support the primary analyses. The a priori threshold for statistical significance was 0.05.|Regression, Multilevel Linear|||ITT analysis for Intrusive memory ratings, 'How distressing were your intrusive memories?' (treatment effects for between-arm comparisons) at week 4. For full information on statistical analysis see Iyadurai et al 2023, https://doi.org/10.1038/s41398-023-02578-0|Please see Iyadurai et al., 2023 Supplementary Tables for within-subjects comparisons (Iyadurai, et al. Transl Psychiatry 13, 290 (2023). https://doi.org/10.1038/s41398-023-02578-0)|-1.54|-3.72|<= 0.001
72441738|NCT04992390|144396910|SUPERIORITY|Multilevel modelling (MLM) was performed with baseline measure, binary arm status, follow-up time and arm-by-time interaction included as fixed-effect covariates. Individual participant was also included as a level-two analytical unit, to quantify: (a) between-group treatment effect estimates and (b) within-group changes between each follow-up time for secondary outcome measures.|Mean Difference (Final Values)|-3.21|||<=|0.001|TWO_SIDED|95.0|-4.28|-2.15||No multiplicity adjustments were applied as there was only one primary outcome, and secondary outcomes aimed to support the primary analyses. The a priori threshold for statistical significance was 0.05.|Regression, Multilevel Linear|||ITT analysis for Intrusive memory ratings, 'How much did they disrupt your concentration?' (treatment effects for between-arm comparisons) at week 4. For full information on statistical analysis see Iyadurai et al 2023, https://doi.org/10.1038/s41398-023-02578-0|Please see Iyadurai et al., 2023 Supplementary Tables for within-subjects comparisons (Iyadurai, et al. Transl Psychiatry 13, 290 (2023). https://doi.org/10.1038/s41398-023-02578-0)|-2.15|-4.28|<= 0.001
72441739|NCT04992390|144396910|SUPERIORITY|Multilevel modelling (MLM) was performed with baseline measure, binary arm status, follow-up time and arm-by-time interaction included as fixed-effect covariates. Individual participant was also included as a level-two analytical unit, to quantify: (a) between-group treatment effect estimates and (b) within-group changes between each follow-up time for secondary outcome measures.|Mean Difference (Final Values)|-2.92|||<=|0.001|TWO_SIDED|95.0|-3.9|-1.95||No multiplicity adjustments were applied as there was only one primary outcome, and secondary outcomes aimed to support the primary analyses. The a priori threshold for statistical significance was 0.05.|Regression, Multilevel Linear|||ITT analysis for Intrusive memory ratings, 'How much did they interfere with what you were doing?' (treatment effects for between-arm comparisons) at week 4. For full information on statistical analysis see Iyadurai et al 2023, https://doi.org/10.1038/s41398-023-02578-0|Please see Iyadurai et al., 2023 Supplementary Tables for within-subjects comparisons. (Iyadurai, et al. Transl Psychiatry 13, 290 (2023). https://doi.org/10.1038/s41398-023-02578-0)|-1.95|-3.90|<= 0.001
72441740|NCT04992390|144396910|SUPERIORITY|Multilevel modelling (MLM) was performed with baseline measure, binary arm status, follow-up time and arm-by-time interaction included as fixed-effect covariates. Individual participant was also included as a level-two analytical unit, to quantify: (a) between-group treatment effect estimates and (b) within-group changes between each follow-up time for secondary outcome measures.|Mean Difference (Final Values)|-2.15|||<=|0.001|TWO_SIDED|95.0|-3.22|-1.08||No multiplicity adjustments were applied as there was only one primary outcome, and secondary outcomes aimed to support the primary analyses. The a priori threshold for statistical significance was 0.05.|Regression, Multilevel Linear|||ITT analysis for Intrusive memory ratings, 'How much did your intrusive memories affect your work functioning?' (treatment effects for between-arm comparisons) at week 4. For full information on statistical analysis see Iyadurai et al 2023, https://doi.org/10.1038/s41398-023-02578-0|Please see Iyadurai et al., 2023 Supplementary Tables for within-subjects comparisons. (Iyadurai, et al. Transl Psychiatry 13, 290 (2023). https://doi.org/10.1038/s41398-023-02578-0)|-1.08|-3.22|<= 0.001
72441741|NCT04992390|144396910|SUPERIORITY|Multilevel modelling (MLM) was performed with baseline measure, binary arm status, follow-up time and arm-by-time interaction included as fixed-effect covariates. Individual participant was also included as a level-two analytical unit, to quantify: (a) between-group treatment effect estimates and (b) within-group changes between each follow-up time for secondary outcome measures.|Mean Difference (Final Values)|-2.59|||<=|0.001|TWO_SIDED|95.0|-3.67|-1.51||No multiplicity adjustments were applied as there was only one primary outcome, and secondary outcomes aimed to support the primary analyses. The a priori threshold for statistical significance was 0.05.|Regression, Multilevel Linear|||ITT analysis for Intrusive memory ratings, 'How much did your intrusive memories affect your functioning in other areas of your life?' (treatment effects for between-arm comparisons) at week 4. For full information on statistical analysis see Iyadurai et al 2023, https://doi.org/10.1038/s41398-023-02578-0|Please see Iyadurai et al., 2023 Supplementary Tables for within-subjects comparisons. (Iyadurai, et al. Transl Psychiatry 13, 290 (2023). https://doi.org/10.1038/s41398-023-02578-0)|-1.51|-3.67|<= 0.001
72496234|NCT04426695|144522405|SUPERIORITY|||||||0.0275||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.0275
72559312|NCT01149057|144648254|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Wilcoxon Signed Rank Test|||Change from baseline at Week 48||||<0.0001
72559313|NCT01149057|144648254|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Wilcoxon Signed Rank Test|||Change from baseline at Week 72||||<0.0001
72559314|NCT01149057|144648254|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Wilcoxon Signed Rank Test|||Change from baseline at Week 96||||<0.0001
72559315|NCT01149057|144648255|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Paired sample T-test|||||||<0.0001
72496235|NCT04426695|144522405|SUPERIORITY|||||||0.0223||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.0223
72496236|NCT04426695|144522405|SUPERIORITY|||||||0.0072||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.0072
72559316|NCT01149057|144648256|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Paired sample T-test|||||||<0.0001
72559317|NCT01149057|144648257|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Paired sample T-test|||||||<0.0001
72559318|NCT01149057|144648258|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Paired sample T-test|||Analysis was performed using paired sample t-test for change from baseline.||||<0.0001
72559319|NCT01149057|144648259|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Paired sample T-test|||||||<0.0001
72559320|NCT01149057|144648260|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Paired sample T-test|||||||<0.0001
72559321|NCT01149057|144648261|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Paired sample T-test|||||||<0.0001
72622348|NCT00835549|144774568|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model containing factors for sequence of products, subjects within sequence, periods, and products was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|98.6||||||90.0|94.8|102.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||102|94.8|
72387703|NCT01890473|144283835|SUPERIORITY_OR_OTHER||ratio of geometric mean|0.941|||||TWO_SIDED|90.0|0.843|1.05||||||The PK comparability of the two devices was assessed via a linear model for each key PK parameter in log scale, using log (AUC (0-T) without a formal test.||1.05|0.843|
72387704|NCT01890473|144283836|SUPERIORITY_OR_OTHER||ratio of geometric mean|0.976|||||TWO_SIDED|90.0|0.888|1.07||||||The PK comparability of the two devices was assessed via a linear model for each key PK parameter in log scale, using log AUC(INF) without a formal test.||1.07|0.888|
72387705|NCT03166735|144283845|OTHER||Predicted mean daily dose in mg|3.45|STANDARD_ERROR_OF_MEAN|0.1|||||||||non-linear regression||The model fit used power of mean variance estimates (POM) to account for heterogeneity.|D10: Estimated dose reaching \<=10% activity the first time.||||
72387706|NCT03166735|144283847|OTHER|The MMRM included fixed effects for 'base', 'treatment', 'time', 'base\*time' interaction, and 'treatment\*time' interaction. Estimates were used to test dose-response relationship using MCPMod.||||||0.0212||||||p\<0.05 is a significant test result (rejecting the null hypothesis of a flat dose-response curve) with alpha 0.05, one-sided.|MCPMod Sigmoidal Emax model fit.|30% of the maximum effect is achieved at 3 mg and 90% of the maximum effect is achieved at 7 mg of BI 1467335||||||0.0212
72387707|NCT03166735|144283848|OTHER|The MMRM included fixed effects for 'base', 'treatment', 'time', 'base\*time' interaction, and 'treatment\*time' interaction. Estimates were used to test dose-response relationship using MCPMod.||||||0.127||||||p\<0.05 is a significant test result (rejecting the null hypothesis of a flat dose-response curve) with alpha 0.05, one-sided.|MCPMod Sigmoidal Emax model fit.|30% of the maximum effect is achieved at 3 mg and 90% of the maximum effect is achieved at 7 mg of BI 1467335||||||0.1270
72387708|NCT03166735|144283849|OTHER|The MMRM included fixed effects for 'base', 'treatment', 'time', 'base\*time' interaction, and 'treatment\*time' interaction. Estimates were used to test dose-response relationship using MCPMod.||||||0.3324||||||p\<0.05 is a significant test result (rejecting the null hypothesis of a flat dose-response curve) with alpha 0.05, one-sided.|MCPMod exponential model fit.|90% of the maximum effect is achieved at 7 mg of BI 1467335||||||0.3324
72387709|NCT03166735|144283850|OTHER|The MMRM included fixed effects for 'base', 'treatment', 'time', 'base\*time' interaction, and 'treatment\*time' interaction. Estimates were used to test dose-response relationship using MCPMod.||||||0.129||||||p\<0.05 is a significant test result (rejecting the null hypothesis of a flat dose-response curve) with alpha 0.05, one-sided.|MCPMod exponential model fit.|90% of the maximum effect is achieved at 7 mg of BI 1467335||||||0.1290
72387710|NCT03166735|144283851|OTHER|The MMRM included fixed effects for 'base', 'treatment', 'time', 'base\*time' interaction, and 'treatment\*time' interaction. Estimates were used to test dose-response relationship using MCPMod.||||||0.0042||||||p\<0.05 is a significant test result (rejecting the null hypothesis of a flat dose-response curve) with alpha 0.05, one-sided.|MCPMod Sigmoidal Emax model fit.|30% of the maximum effect is achieved at 3 mg and 90% of the maximum effect is achieved at 7 mg of BI 1467335||||||0.0042
72387711|NCT03166735|144283852|OTHER|The MMRM included fixed effects for 'base', 'treatment', 'time', 'base\*time' interaction, and 'treatment\*time' interaction. Estimates were used to test dose-response relationship using MCPMod.||||||0.0728||||||p\<0.05 is a significant test result (rejecting the null hypothesis of a flat dose-response curve) with alpha 0.05, one-sided.|MCPMod exponential model fit.|90% of the maximum effect is achieved at 7 mg of BI 1467335||||||0.0728
72387712|NCT01519271|144283854|SUPERIORITY||Cohen's D|0.35|||||TWO_SIDED|||||||||||||
72387713|NCT01292746|144283855|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||t-test, 2 sided|2 sided t-test for correlated samples.||||||<0.05
72496237|NCT04426695|144522406|SUPERIORITY|||||||0.1032||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.1032
72559322|NCT01149057|144648262|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Wilcoxon Signed Rank Test|||Change from baseline at Week 24||||<0.0001
72559323|NCT01149057|144648262|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Wilcoxon Signed Rank Test|||Change from baseline at Week 48||||<0.0001
72559324|NCT01149057|144648262|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Wilcoxon Signed Rank Test|||Change from baseline at Week 72||||<0.0001
72559325|NCT01149057|144648262|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Wilcoxon Signed Rank Test|||Change from baseline at Week 96||||<0.0001
72441742|NCT04992390|144396913|SUPERIORITY|Multilevel modelling (MLM) was performed with baseline measure, binary arm status, follow-up time and arm-by-time interaction included as fixed-effect covariates. Individual participant was also included as a level-two analytical unit, to quantify: (a) between-group treatment effect estimates and (b) within-group changes between each follow-up time for secondary outcome measures.|Mean Difference (Final Values)|-0.8|||<=|0.001|TWO_SIDED|95.0|-1.08|-0.53||No multiplicity adjustments were applied as there was only one primary outcome, and secondary outcomes aimed to support the primary analyses. The a priori threshold for statistical significance was 0.05.|Regression, Multilevel Linear|||ITT analysis for Impact of Event Scale-Revised Total Score (treatment effects for between-arm comparisons) at week 4.|Please see Iyadurai et al., 2023 Supplementary Materials for within-subjects comparisons. (Iyadurai, et al. Transl Psychiatry 13, 290 (2023). https://doi.org/10.1038/s41398-023-02578-0)|-0.53|-1.08|<= 0.001
72441743|NCT04992390|144396913|SUPERIORITY|Multilevel modelling (MLM) was performed with baseline measure, binary arm status, follow-up time and arm-by-time interaction included as fixed-effect covariates. Individual participant was also included as a level-two analytical unit, to quantify: (a) between-group treatment effect estimates and (b) within-group changes between each follow-up time for secondary outcome measures.|Mean Difference (Final Values)|-0.95|||<=|0.001|TWO_SIDED|95.0|-1.27|-0.62||No multiplicity adjustments were applied as there was only one primary outcome, and secondary outcomes aimed to support the primary analyses. The a priori threshold for statistical significance was 0.05.|Regression, Multilevel Linear|||ITT analysis for Impact of Event Scale-Revised Intrusion Subscale (treatment effects for between-arm comparisons) at week 4.|Please see Iyadurai et al., 2023 Supplementary Tables for within-subjects comparisons. (Iyadurai, et al. Transl Psychiatry 13, 290 (2023). https://doi.org/10.1038/s41398-023-02578-0)|-0.62|-1.27|<= 0.001
72441744|NCT04992390|144396913|SUPERIORITY|Multilevel modelling (MLM) was performed with baseline measure, binary arm status, follow-up time and arm-by-time interaction included as fixed-effect covariates. Individual participant was also included as a level-two analytical unit, to quantify: (a) between-group treatment effect estimates and (b) within-group changes between each follow-up time for secondary outcome measures.|Mean Difference (Final Values)|-0.75|||<=|0.001|TWO_SIDED|95.0|-1.09|-0.42||No multiplicity adjustments were applied as there was only one primary outcome, and secondary outcomes aimed to support the primary analyses. The a priori threshold for statistical significance was 0.05.|Regression, Multilevel Linear|||ITT analysis for Impact of Event Scale-Revised Avoidance Subscale (treatment effects for between-arm comparisons) at week 4.|Please see Iyadurai et al., 2023 Supplementary Tables for within-subjects comparisons. (Iyadurai, et al. Transl Psychiatry 13, 290 (2023). https://doi.org/10.1038/s41398-023-02578-0)|-0.42|-1.09|<= 0.001
72441745|NCT04992390|144396913|SUPERIORITY|Multilevel modelling (MLM) was performed with baseline measure, binary arm status, follow-up time and arm-by-time interaction included as fixed-effect covariates. Individual participant was also included as a level-two analytical unit, to quantify: (a) between-group treatment effect estimates and (b) within-group changes between each follow-up time for secondary outcome measures.|Mean Difference (Final Values)|-0.7|||<=|0.001|TWO_SIDED|95.0|-0.97|-0.44||No multiplicity adjustments were applied as there was only one primary outcome, and secondary outcomes aimed to support the primary analyses. The a priori threshold for statistical significance was 0.05.|Regression, Multilevel Linear|||ITT analysis for Impact of Event Scale-Revised Hyperarousal Subscale (treatment effects for between-arm comparisons) at week 4.|Please see Iyadurai et al., 2023 Supplementary Tables for within-subjects comparisons. (Iyadurai, et al. Transl Psychiatry 13, 290 (2023). https://doi.org/10.1038/s41398-023-02578-0)|-0.44|-0.97|<= 0.001
72441746|NCT04992390|144396914|SUPERIORITY|Multilevel modelling (MLM) was performed with baseline measure, binary arm status, follow-up time and arm-by-time interaction included as fixed-effect covariates. Individual participant was also included as a level-two analytical unit, to quantify: (a) between-group treatment effect estimates and (b) within-group changes between each follow-up time for secondary outcome measures.|Mean Difference (Final Values)|-2.29|||<=|0.001|TWO_SIDED|95.0|-3.52|-1.07||No multiplicity adjustments were applied as there was only one primary outcome, and secondary outcomes aimed to support the primary analyses. The a priori threshold for statistical significance was 0.05.|Regression, Multilevel Linear|||ITT analysis for PTSD Checklist for DSM-5 (PCL-5) 4-item version (treatment effects for between-arm comparisons) at week 4.|Please see Iyadurai et al., 2023 Supplementary Materials for within-subjects comparisons.(Iyadurai, et al. Transl Psychiatry 13, 290 (2023). https://doi.org/10.1038/s41398-023-02578-0)|-1.07|-3.52|<= 0.001
72496238|NCT04426695|144522406|SUPERIORITY|||||||0.335||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.3350
72496239|NCT04426695|144522406|SUPERIORITY|||||||0.1314||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.1314
72496240|NCT04426695|144522407|SUPERIORITY|||||||0.00024||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.00024
72496241|NCT04426695|144522407|SUPERIORITY|||||||0.0054||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.0054
72559326|NCT00577655|144648272|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.496||||0.0138|TWO_SIDED|95.0|0.729|6.262||In order to control the overall alpha level at the 0.05 value, each of the primary endpoints were tested separately at the 0.025 level of significance.|ANCOVA|Baseline as covariate and fixed effects of treatment and pooled investigator site.|Active - Placebo|Efficacy was declared if the test for either primary efficacy endpoint was significant at the 0.025 level.||6.262|0.729|0.0138
72387714|NCT00680017|144283872|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||"P values were based on 2 sided tests. Tests resulting in P values less than or equal to 0.050 (when rounded) were reported as statistically significant. No adjustments made for multiple comparisons since only 1 primary efficacy endpoint comparison."|Wilcoxon rank-sum test|||The null hypothesis was that percent change in triglycerides (TG) from baseline to Week 8 in the ABT-335 45 mg plus rosuvastatin 5 mg treatment group is equal to percent change in TG from baseline to Week 8 in the rosuvastatin 5 mg plus placebo treatment group. A sample size of 140 participants per treatment group was used to provide 98% power to detect a difference between the combination therapy arm and the rosuvastatin monotherapy arm in the percent change from Baseline to Week 8 in TG.||||<0.001
72387715|NCT00680017|144283873|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||"P values were based on 2 sided tests. Tests resulting in P values less than or equal to 0.050 (when rounded) were reported as statistically significant. No adjustments made for multiple comparisons since only 1 secondary endpoint comparison."|ANCOVA|P-value obtained from an ANCOVA with corresponding baseline value as the covariate and an effect for treatment group.||The null hypothesis was that percent change in HDL-C from baseline to Week 8 in the ABT-335 45 mg plus rosuvastatin 5 mg treatment group is equal to percent change in HDL-C from baseline to Week 8 in the rosuvastatin 5 mg plus placebo treatment group. A sample size of 140 participants per treatment group was used to provide 82% power to detect a difference between the combination therapy arm and the rosuvastatin monotherapy arm in the percent change from Baseline to Week 8 in HDL-C.||||<0.001
72387716|NCT04572633|144283896|OTHER||Wilson Score|95.5|||||TWO_SIDED|95.0|83.72|100.0|||||Bootstrap sampling with replacement method to account for potential within-subject lesion correlations. Subject is the bootstrap sampling unit, 1,000,000 iterations for bootstrap resampling, and the bias-corrected and accelerated method was used.|||100|83.72|
72387717|NCT04572633|144283897|OTHER||Wilson Score|6.8|||||TWO_SIDED|95.0|2.35|18.23||||||||18.23|2.35|
72387718|NCT00434954|144283978|NON_INFERIORITY_OR_EQUIVALENCE|The planned sample size of 366 patients treated with metformin only (assuming 25% dropouts) gave a power of 85% to detect non-inferiority of exenatide BID for change in HbA1c (non-inferiority margin 0.4%; assumed common standard deviation of 1.1%).|Mean Difference (Net)|0.14||||0.055|TWO_SIDED|95.0|-0.003|0.291||Non-inferiority: upper limit of 95% Confidence Interval (CI) to be \< 0.4%.|Mixed effect model repeat measures(MMRM)|95% CI of treatment group difference derived from MMRM (treatment, week, baseline HbA1c and interactions as fixed effects); p-value: superiority test||The hypothesis was tested hierarchically that 1) exenatide BID is non-inferior to insulin aspart 70/30 BID for glycemic control (change in HbA1c, outcome measure 1), and 2) superior regarding the incidence of hypoglycemia (outcome measure 2). This is the first part of the hierarchical test.||0.291|-0.003|0.055
72387719|NCT00434954|144283979|SUPERIORITY_OR_OTHER|||||||0.554||95.0|||||Chi square test (Pearson)|||||||0.554
72387720|NCT00434954|144283980|SUPERIORITY_OR_OTHER|||||||0.159||95.0|||||Chi square test (Pearson)|||||||0.159
72387721|NCT00434954|144283985|SUPERIORITY_OR_OTHER||||||<|0.05||95.0||||Non overlapping 95% CI's: statistically significant difference p\<0.05.|Kaplan-Meier analysis|For each treatment group, the incidence of hypoglycemia at Week 26 and 95% CIs were derived from Kaplan-Meier analysis.||The hypothesis was tested hierarchically that 1) exenatide BID is non-inferior to insulin aspart BID for glycemic control (outcome measure 1), and 2) superior regarding the incidence of hypoglycemia (outcome measure 2).The planned sample size of 366 patients treated with metformin only (assumed dropout rate 25%) gave 96% power to detect superiority of exenatide BID for the risk of hypoglycemia, assuming incidences of 3.6% for exenatide BID and 17.5% for insulin aspart BID (alpha=0.05).||||<0.05
72387722|NCT00434954|144283986|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||The MMRM model adjusted for baseline HbA1c stratum (HbA1c at baseline \>= 6.5% and \<= 8.0% vs. \> 8.0% and \<=10%).|Mixed effects model repeated measures|95% CI of treatment group difference derived from MMRM (treatment, week, baseline HbA1c and interactions as fixed effects)||||||<0.0001
72387723|NCT00434954|144283987|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||The MMRM model adjusted for baseline HbA1c stratum (HbA1c at Visit 1 \>= 6.5% and \<= 8.0% vs. \> 8.0% and \<=10%).|Mixed effects model repeated measures|95% CI of treatment group difference derived from MMRM (treatment, week, baseline HbA1c and interactions as fixed effects)||||||<0.0001
72496242|NCT04426695|144522407|SUPERIORITY|||||||0.0005||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.0005
72387724|NCT00944671|144283994|NON_INFERIORITY_OR_EQUIVALENCE|Given a 3-period crossover design, assuming a true within subject variance for natural log AUC of 0.029, 24 subjects completing the study, and alpha = 0.05, there is a 0.995 probability that the 90% confidence interval for the true geometric mean ratio of AUC for (famotidine antacid combination EZ Chew tablet without water/ famotidine antacid combination tablet with water) will be contained in (0.80, 1.25), given that the true ratio is one.|Geometric Mean Ratio|1.05||||||90.0|0.98|1.13||||||||1.13|0.98|
72387725|NCT00944671|144283995|NON_INFERIORITY_OR_EQUIVALENCE|Assuming a true within subject variance for natural log Cmax of 0.017, there is a 0.999 probability that the 90% confidence interval for the true geometric mean ratio of Cmax for (famotidine antacid combination EZ Chew tablet without water/ famotidine antacid combination tablet with water) will be contained in (0.80, 1.25), given that the true ratio is one.|Geometric Mean Ratio|1.03||||||90.0|0.93|1.13||||||||1.13|0.93|
72387726|NCT00944671|144283996|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.05||||||90.0|0.98|1.13||||||||1.13|0.98|
72387727|NCT00944671|144283997|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.03||||||90.0|0.93|1.14||||||||1.14|0.93|
72387728|NCT01431989|144284012|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence analysis. This is a bioequivalence study performed to support the register of Clamoxyl 500 mg/5 mL, according to the requirements of Brazilian Regulatory Agency - National Agency of Sanitary Surveillance (ANVISA).|Ratio Geometric mean T/R formulation|90.03|STANDARD_DEVIATION|7.53||0|TWO_SIDED|90.0|86.99|93.17|||ANOVA|ANOVA model: 1) Fixed effects: Sequence, Period, and Formulation; 2) Random effects: Volunteer (Sequence) and Residual|The ratio between the geometric means of the test (T) and reference (R) formulations was calculated. Standard deviation intra subject was obtained.|||93.17|86.99|0.0000
72496243|NCT04426695|144522414|SUPERIORITY|||||||0.0533||||||P-value based on stratified log-rank test with the type of background standard-of-care and baseline serostatus as stratification factors.|Log Rank|||||||0.0533
72496244|NCT04426695|144522414|SUPERIORITY|||||||0.0411||||||P-value based on stratified log-rank test with the type of background standard-of-care and baseline serostatus as stratification factors.|Log Rank|||||||0.0411
72496245|NCT04426695|144522414|SUPERIORITY|||||||0.0229||||||P-value based on stratified log-rank test with the type of background standard-of-care and baseline serostatus as stratification factors.|Log Rank|||||||0.0229
72496246|NCT04426695|144522415|SUPERIORITY|||||||0.0218|||||||Stratified Log Rank Test|||||||0.0218
72496247|NCT04426695|144522415|SUPERIORITY|||||||0.0156|||||||Stratified Log Rank Test|||||||0.0156
72496248|NCT04426695|144522415|SUPERIORITY|||||||0.0067|||||||Stratified Log Rank Test|||||||0.0067
72496249|NCT04426695|144522419|SUPERIORITY|||||||0.2162||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.2162
72496250|NCT04426695|144522419|SUPERIORITY|||||||0.8783||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.8783
72622349|NCT00835549|144774569|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model containing factors for sequence of products, subjects within sequence, periods, and products was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|102.0||||||90.0|98.5|105.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||105|98.5|
72387729|NCT01431989|144284013|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence analysis. This is a bioequivalence study performed to support the register of Clamoxyl 500 mg/5 mL, according to the requirements of Brazilian Regulatory Agency - National Agency of Sanitary Surveillance (ANVISA).|Ratio Geometric mean T/R formulation|87.93|STANDARD_DEVIATION|13.83||0.0018|TWO_SIDED|90.0|82.55|93.65|||ANOVA|ANOVA model: 1) Fixed effects: Sequence, Period, and Formulation; 2) Random effects: Volunteer (Sequence) and Residual|The ratio between the geometric means of the test (T) and reference (R) formulations was calculated. Standard deviation intra subject was obtained.|||93.65|82.55|0.0018
72387730|NCT01431989|144284014|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence analysis. This is a bioequivalence study performed to support the register of Clamoxyl 500 mg/5 mL, according to the requirements of Brazilian Regulatory Agency - National Agency of Sanitary Surveillance (ANVISA).|Ratio Geometric means T/R formulation|90.03|STANDARD_DEVIATION|7.51||0|TWO_SIDED|90.0|86.96|93.12|||ANOVA|ANOVA model: 1) Fixed effects: Sequence, Period, and Formulation; 2) Random effects: Volunteer (Sequence) and Residual|The ratio between the geometric means of the test (T) and reference (R) formulations was calculated. Standard deviation intra subject was obtained.|||93.12|86.96|0.0000
72387731|NCT01431989|144284015|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence analysis. This is a bioequivalence study performed to support the register of Clamoxyl 500 mg/5 mL, according to the requirements of Brazilian Regulatory Agency - National Agency of Sanitary Surveillance (ANVISA).|Median Difference (Final Values)|0.125||||0.339|TWO_SIDED|90.0|-0.125|0.375|||Wilcoxon (Mann-Whitney)|The non-parametric method included the following factors: Sequence, Formulation, Period, Formulation and Residual||||0.375|-0.125|0.3390
72387732|NCT03345914|144284019|SUPERIORITY||Percentage difference|18.1|||=|0.0004|TWO_SIDED|95.0|8.28|27.97||The Cochran-Mantel-Haenszel (CMH) test adjusted by randomization strata (baseline weight group (\< 30 kilograms (kg) or ≥ 30 kg) and region (North America or Europe) was used for the analysis of percentage of participants with IGA 0 or 1 at Week 16.|Cochran-Mantel-Haenszel|||A 2-sided hierarchical testing procedure was used for the primary and secondary endpoints in a pre-specified order. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level.||27.97|8.28|= 0.0004
72387733|NCT03345914|144284019|SUPERIORITY||Percentage difference|21.4|||<|0.0001|TWO_SIDED|95.0|11.36|31.45||The Cochran-Mantel-Haenszel (CMH) test adjusted by randomization strata (baseline weight group (\< 30 kg or ≥ 30 kg) and region (North America or Europe) was used for the analysis of percentage of participants with IGA 0 or 1 at Week 16.|Cochran-Mantel-Haenszel|||A 2-sided hierarchical testing procedure was used for the primary and secondary endpoints in a pre-specified order. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level.||31.45|11.36|< 0.0001
72496251|NCT04426695|144522419|SUPERIORITY|||||||0.5583||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.5583
72496252|NCT04426695|144522419|SUPERIORITY|||||||0.7189||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.7189
72496253|NCT04426695|144522419|SUPERIORITY|||||||0.0429||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.0429
72496254|NCT04426695|144522419|SUPERIORITY|||||||0.2103||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.2103
72496255|NCT04426695|144522420|SUPERIORITY|||||||0.0223||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.0223
72496256|NCT04426695|144522420|SUPERIORITY|||||||0.1256||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.1256
72559327|NCT00577655|144648273|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.431||||0.0403|TWO_SIDED|95.0|0.244|10.618||In order to control the overall alpha level at the 0.05 value, each of the primary endpoints were tested separately at the 0.025 level of significance.|ANCOVA|Baseline as covariate and fixed effects of treatment and pooled investigator site.|Active - Placebo|Efficacy was declared if the test for either primary efficacy endpoint was significant at the 0.025 level.||10.618|0.244|0.0403
72441747|NCT04992390|144396915|SUPERIORITY|Multilevel modelling (MLM) was performed with baseline measure, binary arm status, follow-up time and arm-by-time interaction included as fixed-effect covariates. Individual participant was also included as a level-two analytical unit, to quantify: (a) between-group treatment effect estimates and (b) within-group changes between each follow-up time for secondary outcome measures.|Mean Difference (Final Values)|5.38|||<=|0.001|TWO_SIDED|95.0|2.56|8.2||No multiplicity adjustments were applied as there was only one primary outcome, and secondary outcomes aimed to support the primary analyses. The a priori threshold for statistical significance was 0.05.|Regression, Multilevel Linear|||ITT analysis for Sleep Condition Indicator (SCI) (treatment effects for between-arm comparisons) at week 4.|Please see Iyadurai et al., 2023 Supplementary Materials for within-subjects comparisons. (Iyadurai, et al. Transl Psychiatry 13, 290 (2023). https://doi.org/10.1038/s41398-023-02578-0)|8.20|2.56|<= 0.001
72441748|NCT04992390|144396916|SUPERIORITY|Multilevel modelling (MLM) was performed with baseline measure, binary arm status, follow-up time and arm-by-time interaction included as fixed-effect covariates. Individual participant was also included as a level-two analytical unit, to quantify: (a) between-group treatment effect estimates and (b) within-group changes between each follow-up time for secondary outcome measures.|Mean Difference (Final Values)|-0.93|||<=|0.05|TWO_SIDED|95.0|-1.68|-0.17||No multiplicity adjustments were applied as there was only one primary outcome, and secondary outcomes aimed to support the primary analyses. The a priori threshold for statistical significance was 0.05.|Regression, Multilevel Linear|||ITT analysis for Generalised Anxiety Disorder 2-item scale (GAD-2) (treatment effects for between-arm comparisons) at week 4.|Please see Iyadurai et al., 2023 Supplementary Materials for within-subjects comparisons. (Iyadurai, et al. Transl Psychiatry 13, 290 (2023). https://doi.org/10.1038/s41398-023-02578-0)|-0.17|-1.68|<=0.05
72441749|NCT04992390|144396917|SUPERIORITY|Multilevel modelling (MLM) was performed with baseline measure, binary arm status, follow-up time and arm-by-time interaction included as fixed-effect covariates. Individual participant was also included as a level-two analytical unit, to quantify: (a) between-group treatment effect estimates and (b) within-group changes between each follow-up time for secondary outcome measures.|Mean Difference (Final Values)|-0.52|||>|0.05|TWO_SIDED|95.0|-1.23|0.19||No multiplicity adjustments were applied as there was only one primary outcome, and secondary outcomes aimed to support the primary analyses. The a priori threshold for statistical significance was 0.05.|Regression, Multilevel Linear|||ITT analysis for Patient Health Questionnaire 2-item version (PHQ-2) (treatment effects for between-arm comparisons) at week 4.|Please see Iyadurai et al., 2023 Supplementary Materials for within-subjects comparisons.(Iyadurai, et al. Transl Psychiatry 13, 290 (2023). https://doi.org/10.1038/s41398-023-02578-0)|0.19|-1.23|> .05
72441750|NCT04992390|144396918|SUPERIORITY|Multilevel modelling (MLM) was performed with baseline measure, binary arm status, follow-up time and arm-by-time interaction included as fixed-effect covariates. Individual participant was also included as a level-two analytical unit, to quantify: (a) between-group treatment effect estimates and (b) within-group changes between each follow-up time for secondary outcome measures.|Mean Difference (Final Values)|-6.49|||<=|0.001|TWO_SIDED|95.0|-8.48|-4.51||No multiplicity adjustments were applied as there was only one primary outcome, and secondary outcomes aimed to support the primary analyses. The a priori threshold for statistical significance was 0.05.|Regression, Multilevel Linear|||ITT analysis for Psychological Outcome Profiles (PSYCHLOPS) (treatment effects for between-arm comparisons) at week 4.|Please see Iyadurai et al., 2023 Supplementary Materials for within-subjects comparisons. (Iyadurai, et al. Transl Psychiatry 13, 290 (2023). https://doi.org/10.1038/s41398-023-02578-0)|-4.51|-8.48|<= 0.001
72496257|NCT04426695|144522420|SUPERIORITY|||||||0.023||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.0230
72496258|NCT04426695|144522420|SUPERIORITY|||||||0.1298||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.1298
72496259|NCT04426695|144522420|SUPERIORITY|||||||0.2642||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.2642
72496260|NCT04426695|144522420|SUPERIORITY|||||||0.097||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.0970
72496261|NCT04426695|144522421|SUPERIORITY|||||||0.0147||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.0147
72496262|NCT04426695|144522421|SUPERIORITY|||||||0.0669||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.0669
72559328|NCT00577655|144648274|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.536||||0.0031|TWO_SIDED|95.0|1.567|7.505||significance level of 0.05.|Mixed Models Analysis||Active - Placebo|"Day 1~A repeated measures mixed model, with terms for treatment, pooled center, study day, treatment by study day interaction, and baseline as a covariate, and subject as a random term, was used to make comparisons between placebo and active with respect to FEV1max%0-2 at Days 1 and 22, with observed case data."||7.505|1.567|0.0031
72441751|NCT04992390|144396919|SUPERIORITY|Multilevel modelling (MLM) was performed with baseline measure, binary arm status, follow-up time and arm-by-time interaction included as fixed-effect covariates. Individual participant was also included as a level-two analytical unit, to quantify: (a) between-group treatment effect estimates and (b) within-group changes between each follow-up time for secondary outcome measures.|Mean Difference (Final Values)|-9.78|||<=|0.001|TWO_SIDED|95.0|-15.06|-4.5||No multiplicity adjustments were applied as there was only one primary outcome, and secondary outcomes aimed to support the primary analyses. The a priori threshold for statistical significance was 0.05.|Regression, Multilevel Linear|||ITT analysis for World Health Organization Disability Assessment Schedule 12-item version (WHODAS 2.0) (treatment effects for between-arm comparisons) at week 4.|Please see Iyadurai et al., 2023 Supplementary Materials for within-subjects comparisons. (Iyadurai, et al. Transl Psychiatry 13, 290 (2023). https://doi.org/10.1038/s41398-023-02578-0)|-4.50|-15.06|<= 0.001
72441752|NCT04992390|144396920|SUPERIORITY|Multilevel modelling (MLM) was performed with baseline measure, binary arm status, follow-up time and arm-by-time interaction included as fixed-effect covariates. Individual participant was also included as a level-two analytical unit, to quantify: (a) between-group treatment effect estimates and (b) within-group changes between each follow-up time for secondary outcome measures.|Mean Difference (Final Values)|12.32|||<=|0.01|TWO_SIDED|95.0|4.61|20.04||No multiplicity adjustments were applied as there was only one primary outcome, and secondary outcomes aimed to support the primary analyses. The a priori threshold for statistical significance was 0.05.|Regression, Multilevel Linear|||ITT analysis for 5-level European Quality of Life 5 Dimension (EQ-5D-5L) (treatment effects for between-arm comparisons) at week 4.|Please see Iyadurai et al., 2023 for EQ-5D-5L subscale comparisons and Iyadurai et al., 2023 Supplementary Materials for within-subjects comparisons. (Iyadurai, et al. Transl Psychiatry 13, 290 (2023). https://doi.org/10.1038/s41398-023-02578-0)|20.04|4.61|<= 0.01
72441753|NCT04992390|144396921|SUPERIORITY|Multilevel modelling (MLM) was performed with baseline measure, binary arm status, follow-up time and arm-by-time interaction included as fixed-effect covariates. Individual participant was also included as a level-two analytical unit, to quantify: (a) between-group treatment effect estimates and (b) within-group changes between each follow-up time for secondary outcome measures.|Mean Difference (Final Values)|0.46|||<=|0.001|TWO_SIDED|95.0|0.2|0.71||No multiplicity adjustments were applied as there was only one primary outcome, and secondary outcomes aimed to support the primary analyses. The a priori threshold for statistical significance was 0.05.|Regression, Multilevel Linear|||ITT analysis for Scale of Work Engagement and Burnout (SWEBO) - Work Engagement Subscale (treatment effects for between-arm comparisons) at week 4.|Please see Iyadurai et al., 2023 Supplementary Tables for within-subjects comparisons. (Iyadurai, et al. Transl Psychiatry 13, 290 (2023). https://doi.org/10.1038/s41398-023-02578-0)|0.71|0.20|<= 0.001
72441754|NCT04992390|144396921|SUPERIORITY|Multilevel modelling (MLM) was performed with baseline measure, binary arm status, follow-up time and arm-by-time interaction included as fixed-effect covariates. Individual participant was also included as a level-two analytical unit, to quantify: (a) between-group treatment effect estimates and (b) within-group changes between each follow-up time for secondary outcome measures.|Mean Difference (Final Values)|-0.61|||<=|0.001|TWO_SIDED|95.0|-0.87|-0.34||No multiplicity adjustments were applied as there was only one primary outcome, and secondary outcomes aimed to support the primary analyses. The a priori threshold for statistical significance was 0.05.|Regression, Multilevel Linear|||ITT analysis for Scale of Work Engagement and Burnout (SWEBO) - Work Burnout Subscale (treatment effects for between-arm comparisons) at week 4.|Please see Iyadurai et al., 2023 Supplementary Tables for within-subjects comparisons. (Iyadurai, et al. Transl Psychiatry 13, 290 (2023). https://doi.org/10.1038/s41398-023-02578-0)|-0.34|-0.87|<= 0.001
72441755|NCT04992390|144396922|SUPERIORITY|Multilevel modelling (MLM) was performed with baseline measure, binary arm status, follow-up time and arm-by-time interaction included as fixed-effect covariates. Individual participant was also included as a level-two analytical unit, to quantify: (a) between-group treatment effect estimates and (b) within-group changes between each follow-up time for secondary outcome measures.|Incidence Rate Ratio|1.5|||>|0.05|TWO_SIDED|95.0|0.64|3.51||No multiplicity adjustments were applied as there was only one primary outcome, and secondary outcomes aimed to support the primary analyses. The a priori threshold for statistical significance was 0.05.|Regression, Multilevel Poisson|||ITT analysis for Sickness absence (treatment effects for between-arm comparisons) at week 4.|Please see Iyadurai et al., 2023 Supplementary Materials for within-subjects comparisons. (Iyadurai, et al. Transl Psychiatry 13, 290 (2023). https://doi.org/10.1038/s41398-023-02578-0)|3.51|0.64|> .05
72441756|NCT04992390|144396923|SUPERIORITY|Multilevel modelling (MLM) was performed with baseline measure, binary arm status, follow-up time and arm-by-time interaction included as fixed-effect covariates. Individual participant was also included as a level-two analytical unit, to quantify: (a) between-group treatment effect estimates and (b) within-group changes between each follow-up time for secondary outcome measures.|Mean Difference (Final Values)|-0.86|||>|0.05|TWO_SIDED|95.0|-2.2|0.49||No multiplicity adjustments were applied as there was only one primary outcome, and secondary outcomes aimed to support the primary analyses. The a priori threshold for statistical significance was 0.05.|Regression, Multilevel Linear|||ITT analysis for Intention to leave job (treatment effects for between-arm comparisons) at week 4.|Please see Iyadurai et al., 2023 Supplementary Tables for within-subjects comparisons. (Iyadurai, et al. Transl Psychiatry 13, 290 (2023). https://doi.org/10.1038/s41398-023-02578-0)|0.49|-2.20|> .05
72441757|NCT04992390|144396924|SUPERIORITY|Multilevel modelling (MLM) was performed with baseline measure, binary arm status, follow-up time and arm-by-time interaction included as fixed-effect covariates. Individual participant was also included as a level-two analytical unit, to quantify: (a) between-group treatment effect estimates and (b) within-group changes between each follow-up time for secondary outcome measures.|Incidence Rate Ratio|0.8|||>|0.05|TWO_SIDED|95.0|0.6|1.07||No multiplicity adjustments were applied as there was only one primary outcome, and secondary outcomes aimed to support the primary analyses. The a priori threshold for statistical significance was 0.05.|Regression, Multilevel Poisson|||ITT analysis for number of days worked (treatment effects for between-arm comparisons) at week 4.|Please see Iyadurai et al., 2023 Supplementary Materials for within-subjects comparisons. (Iyadurai, et al. Transl Psychiatry 13, 290 (2023). https://doi.org/10.1038/s41398-023-02578-0)|1.07|0.60|>.05
72441758|NCT04992390|144396925|SUPERIORITY|Multilevel modelling (MLM) was performed with baseline measure, binary arm status, follow-up time and arm-by-time interaction included as fixed-effect covariates. Individual participant was also included as a level-two analytical unit, to quantify: (a) between-group treatment effect estimates and (b) within-group changes between each follow-up time for secondary outcome measures.|Incidence Rate Ratio|1.09|||<|0.05|TWO_SIDED|95.0|0.57|2.09||No multiplicity adjustments were applied as there was only one primary outcome, and secondary outcomes aimed to support the primary analyses. The a priori threshold for statistical significance was 0.05.|Regression, Multilevel Poisson|||ITT analysis for number of nights worked (treatment effects for between-arm comparisons) at week 4.|Please see Iyadurai et al., 2023 Supplementary Materials for within-subjects comparisons. (Iyadurai, et al. Transl Psychiatry 13, 290 (2023). https://doi.org/10.1038/s41398-023-02578-0)|2.09|0.57|<.05
72441759|NCT02807779|144396932|SUPERIORITY|||||||0.22||||||Threshold for statistical significance was p=0.05.|t-test, 2 sided|||"Power calculations were performed based on an expected reproducibility variance of 8% and an effect size of 7% was assumed based on data from pilot studies. It was estimated that 22 subjects/treatment assignment were needed to detect a 7% difference in PWV at a power level of 80%. Assigning a 20% attrition rate due to loss to follow up or index lesion revascularization, the goal enrollment was 27 subjects per arm.~No subjects in the plain balloon angioplasty group had MRI data for analysis."||||0.22
72441760|NCT02807779|144396933|SUPERIORITY|||||||0.64||||||Threshold for statistical significance was p=0.05.|t-test, 2 sided|||No subjects in the plain balloon angioplasty group had MRI data for analysis.||||0.64
72441761|NCT02807779|144396934|SUPERIORITY|||||||0.95||||||Threshold for statistical significance was p=0.05.|t-test, 2 sided|||No subjects in the plain balloon angioplasty group had complete MCP-1 data for analysis.||||0.95
72441762|NCT02807779|144396935|SUPERIORITY|||||||0.88||||||Threshold for statistical significance was p=0.05.|t-test, 2 sided|||No subjects in the plain balloon angioplasty group had complete CRP data for analysis.||||0.88
72441763|NCT02807779|144396937|SUPERIORITY|||||||0.055||||||Threshold for statistical significance was p=0.05.|t-test, 2 sided|||No subjects in the plain balloon angioplasty group had MRI data for analysis.||||.055
72441764|NCT02807779|144396938|SUPERIORITY|||||||0.22||||||Threshold for statistical significance was p=0.05.|t-test, 2 sided|||No subjects in the plain balloon angioplasty group had MRI data for analysis.||||.22
72441765|NCT02807779|144396939|SUPERIORITY|||||||0.81||||||Threshold for statistical significance was p=0.05.|Fisher Exact|||||||0.81
72441766|NCT04994509|144396948|SUPERIORITY||Rate Ratio|0.0|||<|0.0001|TWO_SIDED|95.0|0.0|0.042||p-value for rate ratio vs bHIV is from likelihood ratio test.|Likelihood ratio test||Confidence Interval (CI) for rate ratio vs bHIV is from a likelihood-based method.|Null Hypothesis 01: LEN/bHIV\>= 1; Null hypothesis was to be rejected if HIV-1 incidence in LEN was significantly lower than bHIV.||0.042|0.000|<0.0001
72441767|NCT04994509|144396948|SUPERIORITY||Rate Ratio|0.0|||<|0.0001|TWO_SIDED|95.0|0.0|0.042||p-value for rate ratio vs bHIV is from likelihood ratio test.|Likelihood ratio test||CI for rate ratio vs bHIV is based on a likelihood-based method.|Null Hypothesis 02: LEN/bHIV\>= 0.8; Null hypothesis was to be rejected if HIV-1 incidence in LEN was significantly and at least 20% lower than bHIV.||0.042|0.000|<0.0001
72441768|NCT04994509|144396948|SUPERIORITY||Rate Ratio|0.839||||0.20697|TWO_SIDED|95.0|0.55|1.279||p-value for rate ratio vs bHIV is from Wald test.|Wald test||CI for rate ratio vs bHIV is based on the delta method.|Null Hypothesis 03: F/TAF/bHIV\>= 1; Null hypothesis was to be rejected if HIV-1 incidence in F/TAF was significantly lower than bHIV.||1.279|0.550|0.20697
72441769|NCT04994509|144396948|SUPERIORITY||Rate Ratio|0.839||||0.58674|TWO_SIDED|95.0|0.55|1.279||p-value for rate ratio vs bHIV is from Wald test.|Wald test||CI for rate ratio vs bHIV is based on the delta method.|Null Hypothesis 04: F/TAF/bHIV\>= 0.8; Null hypothesis was to be rejected if HIV-1 incidence in F/TAF was significantly and at least 20% lower than bHIV.||1.279|0.550|0.58674
72441770|NCT04994509|144396949|SUPERIORITY||Rate Ratio|0.0|||<|0.0001|TWO_SIDED|95.0|0.0|0.101||p-value for rate ratio vs F/TDF is from an exact conditional Poisson model.|Poisson model||CI is from an exact conditional Poisson model.|||0.101|0.000|< 0.0001
72441771|NCT04994509|144396949|SUPERIORITY||Rate Ratio|1.198||||0.7282|TWO_SIDED|95.0|0.669|2.143||p-value for rate ratio vs F/TDF is from a Poisson model.|Poisson model||CI is from a Poisson model.|||2.143|0.669|0.72820
72622350|NCT00835549|144774570|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model containing factors for sequence of products, subjects within sequence, periods, and products was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|102.0||||||90.0|98.7|105.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||105|98.7|
72441772|NCT04994509|144396949|OTHER|Comparability to F/TDF is defined as the HIV-1 incidence in the LEN group at most 0.8/100 PY higher than in the F/TDF group.|Rate Difference|-1.685|||<|0.0001|TWO_SIDED|95.0|-2.737|-0.939||p-value for rate difference vs F/TDF is based on a hybrid approach.|Hybrid approach||Exact CI is based on a hybrid approach.|||-0.939|-2.737|<0.0001
72441773|NCT04994509|144396949|OTHER|Comparability to F/TDF is defined as the HIV-1 incidence in the F/TAF group at most 0.8/100 PY higher than in the F/TDF group.|Rate Difference|0.333||||0.209|TWO_SIDED|95.0|-0.869|1.367||p-value for rate difference vs F/TDF is based on a hybrid approach.|Hybrid approach||Exact CI is based on a hybrid approach.|||1.367|-0.869|0.20900
72441774|NCT04994509|144396951|SUPERIORITY||Exact Odds Ratio|9.0||||0.0006|TWO_SIDED|95.0|2.06|83.36||p-value is from exact conditional logistic regression model.|ExactConditionalLogisticRegressionModel||Exact odds ratio and and CI are from exact conditional logistic regression model.|||83.36|2.06|0.0006
72441775|NCT05505045|144396970|OTHER||Cohen's d effect size|0.44|||||TWO_SIDED|95.0|-0.16|1.05||||||||1.05|-.16|
72441776|NCT05505045|144396971|OTHER||Cohen's d effect size|0.42|||||TWO_SIDED|95.0|-0.19|1.03||||||||1.03|-.19|
72441777|NCT05505045|144396972|OTHER||Cohen's d effect size|0.31|||||TWO_SIDED|95.0|-0.3|0.93||||||||0.93|-.30|
72441778|NCT05505045|144396973|OTHER||Cohen's d effect size|-0.42|||||TWO_SIDED|96.0|-1.04|0.21||||||||0.21|-1.04|
72441779|NCT05505045|144396978|OTHER||Cohen's d effect size|0.01|||||TWO_SIDED|95.0|-0.61|0.64||||||||.64|-.61|
72441780|NCT01643070|144396979|SUPERIORITY||Odds Ratio (OR)|1.5||||0.719|TWO_SIDED|95.0|0.346|6.501|||t-test, 1 sided|||||6.501|0.346|0.719
72441781|NCT05540535|144396990|SUPERIORITY||||||<|0.05|||||||Kruskal-Wallis|The Wilcoxon signed-rank test was used for a within-group comparison.||||||<0.05
72441782|NCT05540535|144396991|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<0.05
72441783|NCT05540535|144396992|SUPERIORITY||||||<|0.05|||||||Kruskal-Wallis|The Wilcoxon signed-rank test was used for a within-group comparison.||||||<0.05
72441784|NCT05540535|144396993|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<0.05
72441785|NCT05540535|144396994|SUPERIORITY|||||||0.05|||||||ANOVA|||||||0.05
72441786|NCT05540535|144396995|SUPERIORITY|||||||0.05|||||||ANOVA|||||||0.05
72441787|NCT05540535|144396996|SUPERIORITY|||||||0.05|||||||ANOVA|||||||0.05
72441788|NCT03089125|144396997|SUPERIORITY||Mean Difference (Final Values)|-0.33||||0.038|TWO_SIDED|95.0|-0.61|-0.05||Bonferroni-adjusted P-value|ANCOVA|ANCOVA models control for cancer type, study site, and baseline scores of outcome variable.||||-0.05|-0.61|0.038
72441789|NCT03089125|144396998|SUPERIORITY||Mean Difference (Final Values)|-0.55|||>|0.99|TWO_SIDED|95.0|-2.2|1.1||Bonferroni-adjusted P-value|ANCOVA|ANCOVA models control for cancer type, study site, and baseline scores of outcome variable.||||1.10|-2.20|>0.99
72441790|NCT03089125|144396999|SUPERIORITY||Mean Difference (Final Values)|1.6||||0.38|TWO_SIDED|95.0|-1.98|5.18|||ANCOVA|ANCOVA models control for cancer type, study site, and baseline scores of outcome variable.||||5.18|-1.98|0.380
72496263|NCT04426695|144522421|SUPERIORITY|||||||0.0094||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.0094
72441791|NCT03089125|144397000|SUPERIORITY||Mean Difference (Final Values)|-0.01||||0.99|TWO_SIDED|95.0|-0.83|0.82|||ANCOVA|ANCOVA models control for cancer type, study site, and baseline scores of outcome variable.||||0.82|-0.83|0.990
72441792|NCT03089125|144397001|SUPERIORITY||Mean Difference (Final Values)|-0.49||||0.251|TWO_SIDED|95.0|-1.34|0.35|||ANCOVA|||||0.35|-1.34|0.251
72441793|NCT03089125|144397002|SUPERIORITY||Mean Difference (Final Values)|-1.49||||0.647|TWO_SIDED|95.0|-7.9|4.92|||ANCOVA|ANCOVA models control for cancer type, study site, and baseline scores of outcome variable.||||4.92|-7.90|0.647
72441794|NCT03089125|144397003|SUPERIORITY||Mean Difference (Final Values)|1.63||||0.431|TWO_SIDED|95.0|-2.45|5.71||ANCOVA models control for cancer type, study site, and baseline scores of outcome variable.|ANCOVA|||||5.71|-2.45|0.431
72496264|NCT04426695|144522421|SUPERIORITY|||||||0.1306||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.1306
72622351|NCT00835042|144774571|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|92.5||||||90.0|85.8|99.8|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||99.8|85.8|
72441795|NCT03089125|144397004|SUPERIORITY||Between-group diff in change per 8 weeks|-0.06||||0.71|TWO_SIDED|95.0|-0.38|0.26|||Mixed Models Analysis|Estimated between-group difference in change in scores per every 8 weeks from baseline through week 24, controlling for cancer type and study site.||||0.26|-0.38|0.710
72441796|NCT03089125|144397005|SUPERIORITY||Between-group diff in change per 8 weeks|0.38||||0.677|TWO_SIDED|95.0|-1.4|2.16|||Mixed Models Analysis|Estimated between-group difference in change in scores per every 8 weeks from baseline through week 24, controlling for cancer type and study site.||||2.16|-1.40|0.677
72441797|NCT03089125|144397006|SUPERIORITY||Between-group diff in change per 8 weeks|-1.95||||0.33|TWO_SIDED|95.0|-5.87|1.97|||Mixed Models Analysis|Estimated between-group difference in change in scores per every 8 weeks from baseline through week 24, controlling for cancer type and study site.||||1.97|-5.87|0.330
72441798|NCT03089125|144397007|SUPERIORITY||Between-group diff in change per 8 weeks|0.73||||0.098|TWO_SIDED|95.0|-0.13|1.59|||Mixed Models Analysis|Estimated between-group difference in change in scores per every 8 weeks from baseline through week 24, controlling for cancer type and study site.||||1.59|-0.13|0.098
72441799|NCT03089125|144397008|SUPERIORITY||Between-group diff in change per 8 weeks|0.08||||0.845|TWO_SIDED|95.0|-0.76|0.93|||Mixed Models Analysis|Estimated between-group difference in change in scores per every 8 weeks from baseline through week 24, controlling for cancer type and study site.||||0.93|-0.76|0.845
72441800|NCT03089125|144397009|SUPERIORITY||Between-group diff in change per 8 weeks|0.74||||0.837|TWO_SIDED|95.0|-6.33|7.77|||Mixed Models Analysis|Estimated between-group difference in change in scores per every 8 weeks from baseline through week 24, controlling for cancer type and study site.||||7.77|-6.33|0.837
72441801|NCT04605198|144397013|SUPERIORITY|A multilevel model was constructed. Participants were entered as random effects to nest observations within participants. Group assignment (i.e., MBSR vs. Health Promotion Control), time (i.e., Time 1 \[baseline\], Time 2 \[immediate post-intervention, primary endpoint\], and Time 3 \[6-month follow-up\]), and group-by-time interactions were entered as fixed effects. Site was also included as a fixed-effect. An independent covariance pattern was specified as final models were random-intercept only.|Mean Difference (Net)|-0.58||||0.846|TWO_SIDED|95.0|-6.46|5.29|||Mixed Models Analysis||The estimate represents the interaction term for group by time interaction for the immediate follow-up, with the control group coded 0 and the intervention group coded as 1.|||5.29|-6.46|.846
72441802|NCT04605198|144397014|SUPERIORITY||Mean Difference (Net)|-1.88||||0.139|TWO_SIDED|95.0|-4.36|0.6|||Mixed Models Analysis||The estimate represents the interaction term for group by time interaction for the immediate follow-up, with the control group coded 0 and the intervention group coded as 1.|A multilevel model was constructed. Participants were entered as random effects to nest observations within participants. Group assignment (i.e., MBSR vs. Health Promotion Control), time (i.e., Time 1 \[baseline\], Time 2 \[immediate post-intervention, primary endpoint\], and Time 3 \[6-month follow-up\]), and group-by-time interactions were entered as fixed effects. Site was also included as a fixed-effect. An independent covariance pattern was specified as final models were random-intercept only.||0.60|-4.36|.139
72496265|NCT04426695|144522421|SUPERIORITY|||||||0.3576||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.3576
72441803|NCT04605198|144397015|SUPERIORITY||Mean Difference (Net)|-0.12||||0.222|TWO_SIDED|95.0|-1.21|0.97|||Mixed Models Analysis||The estimate represents the interaction term for group by time interaction for the immediate follow-up, with the control group coded 0 and the intervention group coded as 1.|A multilevel model was constructed. Participants were entered as random effects to nest observations within participants. Group assignment (i.e., MBSR vs. Health Promotion Control), time (i.e., Time 1 \[baseline\], Time 2 \[immediate post-intervention, primary endpoint\], and Time 3 \[6-month follow-up\]), and group-by-time interactions were entered as fixed effects. Site was also included as a fixed-effect. An independent covariance pattern was specified as final models were random-intercept only.||0.97|-1.21|.222
72441804|NCT04605198|144397016|SUPERIORITY||Odds Ratio, log|-1.76||||0.166|TWO_SIDED|95.0|-4.26|0.73|||Mixed Models Analysis||The estimate represents the interaction term for group by time interaction for the immediate follow-up, with the control group coded 0 and the intervention group coded as 1.|A multilevel model was constructed using a logit distribution. Participants were entered as random effects to nest observations within participants. Group assignment (i.e., MBSR vs. Health Promotion Control), time (i.e., Time 1 \[baseline\], Time 2 \[immediate post-intervention\], and Time 3 \[6-month follow-up\]), and group-by-time interactions were entered as fixed effects. Site was included as a fixed-effect. An independent covariance pattern was specified. Final models were random-intercept only.||0.73|-4.26|0.166
72441805|NCT04605198|144397017|SUPERIORITY||Mean Difference (Net)|-0.52||||0.737|TWO_SIDED|95.0|-3.57|2.53|||Mixed Models Analysis||The estimate represents the interaction term for group by time interaction for the immediate follow-up, with the control group coded 0 and the intervention group coded as 1.|A multilevel model was constructed. Participants were entered as random effects to nest observations within participants. Group assignment (i.e., MBSR vs. Health Promotion Control), time (i.e., Time 1 \[baseline\], Time 2 \[immediate post-intervention, primary endpoint\], and Time 3 \[6-month follow-up\]), and group-by-time interactions were entered as fixed effects. Site was also included as a fixed-effect. An independent covariance pattern was specified as final models were random-intercept only.||2.53|-3.57|.737
72441806|NCT04605198|144397018|SUPERIORITY||Mean Difference (Net)|-2391.98||||0.024|TWO_SIDED|95.0|-4471.46|-312.49|||Mixed Models Analysis||The estimate represents the interaction term for group by time interaction for the immediate follow-up, with the control group coded 0 and the intervention group coded as 1.|A multilevel model was constructed. Participants were entered as random effects to nest observations within participants. Group assignment (i.e., MBSR vs. Health Promotion Control), time (i.e., Time 1 \[baseline\], Time 2 \[immediate post-intervention, primary endpoint\], and Time 3 \[6-month follow-up\]), and group-by-time interactions were entered as fixed effects. Site was also included as a fixed-effect. An independent covariance pattern was specified as final models were random-intercept only.||-312.49|-4471.46|.024
72441807|NCT04038957|144397019|SUPERIORITY|||||||0.0072||||||A p-value of p\<0.05 will be considered as significant.|Repeated Measures ANOVA|||To examine the primary outcome, the effects of SEP-363856 on the striatum, a repeated measures ANOVA model will be build using the baseline and on-treatment kicer values of each striatal subregion.||||0.0072
72441808|NCT01998984|144397024|SUPERIORITY||Relative risk|2.97||||0.18|TWO_SIDED|95.0|0.6|14.74||P-value was adjusted for analysis site using Rubin's pooling methodology after log transformation of RR (relative risk) of each imputation. Complete clearance relative to vehicle group and 2-day group.|Cochran-Mantel-Haenszel||Relative risk and confidence interval were adjusted for analysis site using Rubin's pooling methodology after log transformation of RR of each imputation. Complete clearance relative to vehicle group and 2-day group.|"Treatment comparison based on 1000 imputations of AK count at week 8 using a negative binomial regression model with factors treatment and analysis site and with log of baseline AK count as offset.~Cochran-Mantel-Haenszel logit estimators were used for comparisons with vehicle due to absence of cleared participant in the vehicle group."||14.74|0.60|0.18
72441809|NCT01998984|144397024|SUPERIORITY||Relative risk|3.51||||0.051|TWO_SIDED|95.0|1.0|12.41||P-value was adjusted for analysis site using Rubin's pooling methodology after log transformation of RR (relative risk) of each imputation. Complete clearance relative to vehicle group and 2-day group.|Cochran-Mantel-Haenszel||Relative risk and confidence interval were adjusted for analysis site using Rubin's pooling methodology after log transformation of RR of each imputation. Complete clearance relative to vehicle group and 2-day group.|"Treatment comparison based on 1000 imputations of AK count at week 8 using a negative binomial regression model with factors treatment and analysis site and with log of baseline AK count as offset.~Cochran-Mantel-Haenszel logit estimators were used for comparisons with vehicle due to absence of cleared subject in the vehicle group.~Type I error not controlled."||12.41|1.00|0.051
72441810|NCT01998984|144397024|SUPERIORITY||Relative risk|0.47||||0.25|TWO_SIDED|95.0|0.13|1.68||P-value was adjusted for analysis site using Rubin's pooling methodology after log transformation of RR (relative risk) of each imputation. Complete clearance relative to vehicle group and 2-day group.|Mantel Haenszel||Relative risk and confidence interval were adjusted for analysis site using Rubin's pooling methodology after log transformation of RR of each imputation. Complete clearance relative to vehicle group and 2-day group.|"Treatment comparison based on 1000 imputations of AK count at week 8 using a negative binomial regression model with factors treatment and analysis site and with log of baseline AK count as offset.~Type I error not controlled. Mantel-Haenszel estimators were used."||1.68|0.13|0.25
72496266|NCT04426695|144522421|SUPERIORITY|||||||0.1476||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.1476
72496267|NCT04426695|144522422|SUPERIORITY|||||||0.0481||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.0481
72622352|NCT00835042|144774572|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|98.9||||||90.0|92.2|106.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||106|92.2|
72559329|NCT00577655|144648274|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.067||||0.047|TWO_SIDED|95.0|0.041|6.094||significance level of 0.05.|Mixed Models Analysis||Active - Placebo|"Day 22~A repeated measures mixed model, with terms for treatment, pooled center, study day, treatment by study day interaction, and baseline as a covariate, and subject as a random term, was used to make comparisons between placebo and active with respect to FEV1max%0-2 at Days 1 and 22, with observed case data."||6.094|0.041|0.0470
72441811|NCT01998984|144397025|SUPERIORITY||Ratio of adjusted mean|0.4|||<|0.001|TWO_SIDED|95.0|0.32|0.51||P-value was from negative binomial regression model with factors treatment and analysis site and with log of baseline AK count as offset with 1000 Imputations.|Negative binomial regression||Estimation parameter and confidence interval were from negative binomial regression model with factors treatment and analysis site and with log of baseline AK count as offset with 1000 Imputations.|||0.51|0.32|<0.001
72441812|NCT01998984|144397025|SUPERIORITY||Ratio of adjusted mean|0.36|||<|0.001|TWO_SIDED|95.0|0.29|0.45||P-value was from negative binomial regression model with factors treatment and analysis site and with log of baseline AK count as offset with 1000 Imputations.|Negative binomial regression||Estimation parameter and confidence interval were from negative binomial regression model with factors treatment and analysis site and with log of baseline AK count as offset with 1000 Imputations.|||0.45|0.29|<0.001
72441813|NCT01998984|144397025|SUPERIORITY||Ratio of adjusted mean|0.89||||0.36|TWO_SIDED|95.0|0.7|1.14||P-value was from negative binomial regression model with factors treatment and analysis site and with log of baseline AK count as offset with 1000 Imputations.|Negative binomial regression||Estimation parameter and confidence interval were from negative binomial regression model with factors treatment and analysis site and with log of baseline AK count as offset with 1000 Imputations.|||1.14|0.70|0.36
72441814|NCT01998984|144397026|SUPERIORITY||Relative risk|32.26|||<|0.001|TWO_SIDED|95.0|4.39|236.8||P value adjusted for analysis site.|Cochran-Mantel-Haenszel||Relative risk and confidence interval were adjusted for analysis site and were Mantel-Haenszel estimators. Relative risk of partial clearance relative to vehicle group.|The treatment comparison was based on 1000 imputations of AK count at week 8 using a negative binomial regression model with factors treatment and analysis site and with log of baseline AK count as offset.||236.8|4.39|<0.001
72441815|NCT01998984|144397026|SUPERIORITY||Relative risk|25.2||||0.002|TWO_SIDED|95.0|3.39|187.4||Adjusted for analysis site. Relative risk of partial clearance relative to vehicle group.|Cochran-Mantel-Haenszel||Relative risk and confidence interval were adjusted for analysis site and were Mantel-Haenszel estimators. Relative risk of partial clearance relative to vehicle group.|The treatment comparison was based on 1000 imputations of AK count at week 8 using a negative binomial regression model with factors treatment and analysis site and with log of baseline AK count as offset.||187.4|3.39|0.002
72441816|NCT01998984|144397026|SUPERIORITY||Relative risk|1.2||||0.28|TWO_SIDED|95.0|0.86|1.65||Adjusted for analysis site. Relative risk of partial clearance relative to 2-day group.|Cochran-Mantel-Haenszel||Relative risk and confidence interval were adjusted for analysis site and were Mantel-Haenszel estimators. Relative risk of partial clearance relative to vehicle group.|The treatment comparison was based on 1000 imputations of AK count at week 8 using a negative binomial regression model with factors treatment and analysis site and with log of baseline AK count as offset.||1.65|0.86|0.28
72441817|NCT01843374|144397029|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.92||||0.4081|TWO_SIDED|95.0|0.76|1.12||P-value was estimated using the method of Klein et al. 2007 and Whitehead and Whitehead 1991, stratified by EORTC status and Line of therapy.|Log Rank|The stratification factors included EORTC status and line of therapy as recorded in IVRS/IWRS.|Tremelimumab represents the numerator and Placebo the denominator|H0: No difference between tremelimumab and placebo H1: Difference between tremelimumab and placebo||1.12|0.76|0.4081
72622353|NCT00835042|144774573|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|99.1||||||90.0|92.3|106.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||106|92.3|
72441818|NCT01843374|144397030|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.011||||0.926|TWO_SIDED|95.0|0.793|1.289||Estimated using the methods of Klein et al. 2007 and Whitehead and Whitehead 1991, stratified by EORTC status and line of therapy.|Log Rank||Tremelimumab is the numerator and Placebo the denominator|||1.289|0.793|0.926
72441819|NCT01843374|144397031|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.81||||0.0325|TWO_SIDED|95.0|0.68|0.98||Estimated using the methods of Klein et al. 2007 and Whitehead and Whitehead 1991, stratified by EORTC status and line of therapy.|Log Rank|Stratification factors were EORTC status and Line of therapy|Tremelimumab is the numerator and placebo, the denominator|||0.98|0.68|0.0325
72441820|NCT03397108|144397039|SUPERIORITY|||||||0.89||||||The a priori threshold of significance was set at 0.05. Not adjusted for multiple comparison.|Wilcoxon (Mann-Whitney)|||Milk TNF levels at EARLY LACTATION PERIOD were compared between non-IBD control and women with IBD. Our hypothesis was that women with IBD have higher TNF in milk due to the underlying inflammatory condition (IBD).||||0.89
72441821|NCT03397108|144397039|SUPERIORITY|||||||0.024|||||||Kruskal-Wallis|||"Milk TNF at the EARLY LACTATION PERIOD was compared among the 3 groups: non-IBD control, IBD subgroup On TNFmAb and IBD subgroup Off TNFmAb. We hypothesized that the use of TNFmAb decreases milk TNF. Nonparametric comparison of 3 groups was done with one-way ANOVA on ranks (Kruskal-Wallis test), followed by multiplicity-adjusted pairwise comparisons with Dunn's test."||||0.024
72441822|NCT03397108|144397039|SUPERIORITY|||||||0.7||||||The a priori threshold of significance was set at 0.05. Not adjusted for multiple comparison.|Wilcoxon (Mann-Whitney)|||Milk MCP1 levels (TNF dependent chemokine) at the EARLY LACTATION PERIOD were compared between non-IBD control and IBD group to see if there is a difference.||||0.70
72441823|NCT03397108|144397039|SUPERIORITY|||||||0.93||||||Not adjusted for multiple comparison.|Wilcoxon (Mann-Whitney)|||Milk levels of MIP-1 beta (TNF dependent chemokine) at the EARLY LACTATION PERIOD were compared between non-IBD control and IBD group to see if there is a difference.||||0.93
72622354|NCT00835042|144774574|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|105.0||||||90.0|99.3|111.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||111|99.3|
72441824|NCT03397108|144397039|SUPERIORITY|||||||0.12||||||The a priori threshold of significance was set at 0.05. Not adjusted for multiple comparison.|Wilcoxon (Mann-Whitney)|||Milk IP10 levels (one of the TNF dependent chemokines) at EARLY LACTATION PERIOD were compared between non-IBD control and IBD group to see if there is a difference.||||0.12
72441825|NCT03397108|144397039|SUPERIORITY|||||||0.12|||||||Kruskal-Wallis|||Milk levels of TNF-dependent chemokine, MCP1, at the EARLY LACTATION PERIOD was compared among the 3 groups: non-IBD control and the 2 IBD subgroups. We hypothesized that the use of TNFmAb decreases milk TNF and TNF-dependent chemokine including MCP1. Nonparametric comparison of the 3 groups was done with one-way ANOVA on ranks (Kruskal-Wallis test), followed by multiplicity-adjusted pairwise comparisons with Dunn's test.||||0.12
72441826|NCT03397108|144397039|SUPERIORITY|||||||0.051|||||||Kruskal-Wallis|||"Milk MIP-1beta at the EARLY LACTATION PERIOD was compared among the 3 groups: non-IBD control, IBD subgroup On TNFmAb and IBD subgroup Off TNFmAb. We hypothesized that the use of TNFmAb decreases milk TNF and TNF-dependent chemokine including MIP-1beta. Nonparametric comparison of 3 groups was done with one-way ANOVA on ranks (Kruskal-Wallis test), followed by multiplicity-adjusted pairwise comparisons with Dunn's test."||||0.051
72441827|NCT03397108|144397039|SUPERIORITY|||||||0.0046|||||||Kruskal-Wallis|||"Milk IP10 at the EARLY LACTATION PERIOD was compared among the 3 groups: non-IBD control, IBD subgroup On TNFmAb and IBD subgroup Off TNFmAb. We hypothesized that the use of TNFmAb decreases milk TNF and TNF-dependent chemokine including IP10. Nonparametric comparison of 3 groups was done with one-way ANOVA on ranks (Kruskal-Wallis test), followed by multiplicity-adjusted pairwise comparisons with Dunn's test."||||0.0046
72441828|NCT03397108|144397039|SUPERIORITY|||||||0.35||||||Not adjusted for multiple comparison.|Wilcoxon (Mann-Whitney)|||Comparison of milk TNF level at the MID LACTATION POINT between non-IBD control and IBD group. The same analytical framework as the early lactation, but this is based on data at the mid-lactation point (13-14 postpartum weeks). Our hypothesis is the same as for the early-lactation point.||||0.35
72441829|NCT03397108|144397039|SUPERIORITY|||||||0.11|||||||Kruskal-Wallis|||"Milk TNF at MID LACTATION POINT was compared among the 3 groups: non-IBD control, IBD subgroup On TNFmAb and IBD subgroup Off TNFmAb. Hypothesis is the same as for the early lactation point. Nonparametric comparison of 3 groups was done with one-way ANOVA on ranks (Kruskal-Wallis test), followed by multiplicity-adjusted pairwise comparisons with Dunn's test."||||0.11
72441830|NCT03397108|144397039|SUPERIORITY|||||||0.26||||||Not adjusted for multiple comparison.|Wilcoxon (Mann-Whitney)|||Milk MCP1 level comparison between non-IBD control and IBD group at the MID LACTATION POINT(13-14 postpartum weeks). Our hypothesis is the same as for the early-lactation point.||||0.26
72441831|NCT03397108|144397039|SUPERIORITY|||||||0.15||||||Not adjusted for multiple comparison.|Wilcoxon (Mann-Whitney)|||Milk MIP-1beta level comparison between non-IBD control and IBD group at the MID LACTATION POINT (13-14 postpartum weeks). Our hypothesis is the same as for the early-lactation point.||||0.15
72441832|NCT03397108|144397039|SUPERIORITY|||||||0.31||||||Not adjusted for multiple comparison.|Wilcoxon (Mann-Whitney)|||Milk IP10 level comparison between non-IBD control and IBD group at the MID LACTATION POINT (13-14 postpartum weeks). Our hypothesis is the same as for the early-lactation point.||||0.31
72441833|NCT03397108|144397039|SUPERIORITY|||||||0.21|||||||Kruskal-Wallis|||"Milk MCP-1 at the MID LACTATION PERIOD was compared among the 3 groups: non-IBD control, IBD subgroup On TNFmAb and IBD subgroup Off TNFmAb. The hypothesis is the same as that for the early-lactation period. Nonparametric comparison of 3 groups was done with one-way ANOVA on ranks (Kruskal-Wallis test), followed by multiplicity-adjusted pairwise comparisons with Dunn's test."||||0.21
72496268|NCT04426695|144522422|SUPERIORITY|||||||0.0535||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.0535
72496269|NCT04426695|144522422|SUPERIORITY|||||||0.0199||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.0199
72559330|NCT00577655|144648275|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|7.572||||0.0074|TWO_SIDED|95.0|2.077|13.067||significance level of 0.05.|repeated measures ANOVA||Active - Placebo|"Day 1~A repeated measures mixed model, with terms for treatment, pooled center, study day, treatment by study day interaction, and baseline as a covariate, and subject as a random term, was used to make comparisons between placebo and active with respect to PEFmax%0-2 at Days 1 and 22, with observed case data."||13.067|2.077|0.0074
72441834|NCT03397108|144397039|SUPERIORITY|||||||0.12|||||||Kruskal-Wallis|||"Milk MIP-1beta at the MID LACTATION POINT was compared among the 3 groups: non-IBD control, IBD subgroup On TNFmAb and IBD subgroup Off TNFmAb. The hypothesis is the same as that for the early-lactation period. Nonparametric comparison of 3 groups was done with one-way ANOVA on ranks (Kruskal-Wallis test), followed by multiplicity-adjusted pairwise comparisons with Dunn's test."||||0.12
72441835|NCT03397108|144397039|SUPERIORITY|||||||0.29|||||||Kruskal-Wallis|||"Milk IP10 at the MID LACTATION POINT was compared among the 3 groups: non-IBD control, IBD subgroup On TNFmAb and IBD subgroup Off TNFmAb. The same hypothesis as that for the early-lactation period. Nonparametric comparison of 3 groups was done with one-way ANOVA on ranks (Kruskal-Wallis test), followed by multiplicity-adjusted pairwise comparisons with Dunn's test."||||0.29
72441836|NCT03397108|144397039|OTHER|Correlation analysis|Spearman rank correlation|0.7232|||<|0.0001|TWO_SIDED|95.0|0.5647|0.8303||Not adjusted for multiple comparison|Spearman rank correlation|||Using the pooled data of all participants at the EARLY LACTATION, we analyzed correlation between milk TNF and chemokine MCP1 to see if they are positively correlated. This is to show supportive evidence for TNF dependency of chemokine MCP1.||0.8303|0.5647|<0.0001
72441837|NCT03397108|144397039|OTHER|Correlation analysis|Spearman rank correlation|0.6835|||<|0.0001|TWO_SIDED|95.0|0.5088|0.8042||Not adjusted for multiple comparison|Spearman rank correlation|||Using the pooled data of all participants at the EARLY LACTATION, we analyzed correlation between milk TNF and chemokine MIP-1beta to see if they are positively correlated. This is to show supportive evidence for TNF dependency of chemokine MIP-1beta.||0.8042|0.5088|<0.0001
72496270|NCT04426695|144522422|SUPERIORITY|||||||0.2784||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.2784
72441838|NCT03397108|144397039|OTHER|Correlation analysis|Spearman rank correlation|0.6316|||<|0.0001|TWO_SIDED|95.0|0.4377|0.7693||Not adjusted for multiple comparison|Spearman rank correlation|||Using the pooled data of all participants at the EARLY LACTATION, we analyzed correlation between milk TNF and chemokine IP10 to see if they are positively correlated. This is to show supportive evidence for TNF dependency of chemokine IP10.||0.7693|0.4377|<0.0001
72441839|NCT03397108|144397039|OTHER|Correlation analysis|Spearman rank correlation|0.572|||<|0.0001|TWO_SIDED|95.0|0.3445|0.736||Not adjusted for multiple comparison|Spearman rank correlation|||Using the pooled data of all participants at the MID LACTATION POINT, we analyzed correlation between milk TNF and MCP1 to see of they are positively correlated.||0.7360|0.3445|<0.0001
72441840|NCT03397108|144397039|OTHER|Correlation analysis|Spearman rank correlation|0.7564|||<|0.0001|TWO_SIDED|95.0|0.6022|0.8562||Not adjusted for multiple comparison|Spearman rank correlation|||Using the pooled data of all participants at the MID LACTATION POINT, we analyzed correlation between milk TNF and MIP-1beta to see of they are positively correlated.||0.8562|0.6022|<0.0001
72441841|NCT03397108|144397039|OTHER|Correlation analysis|Spearman rank correlation|0.32||||0.0227|TWO_SIDED|95.0|0.03869|0.552||Not adjusted for multiple comparison|Spearman rank correlation|||Using the pooled data of all participants at the MID LACTATION POINT, we analyzed correlation between milk TNF and IP10 to see of they are positively correlated.||0.5520|0.03869|0.0227
72441842|NCT03397108|144397039|OTHER|Correlation analysis|Spearman rank correlation|0.52||||0.0001|TWO_SIDED|95.0|0.2727|0.6975||Not adjusted for multiple comparison|Spearman rank correlation|||Using the pooled data of all participants, we assessed temporal tracking of milk TNF between early and mid-lactation points.||0.6975|0.2727|0.0001
72441843|NCT03397108|144397039|OTHER|Correlation analysis|Spearman rank correlation|0.4722||||0.0005|TWO_SIDED|95.0|0.2181|0.6664||Not adjusted for multiple comparison.|Spearman rank correlation|||Using the pooled data of all participants, we assessed temporal tracking of milk MCP1 between early and mid-lactation points.||0.6664|0.2181|0.0005
72441844|NCT03397108|144397039|OTHER|Correlation analysis|Spearman rank correlation|0.36||||0.01|TWO_SIDED|95.0|0.0802|0.5803||Not adjusted for multiple comparison|Spearman rank correlation|||Using the pooled data of all participants, we assessed temporal tracking of milk MIP-1beta between early and mid-lactation points.||0.5803|0.0802|0.01
72441845|NCT03397108|144397039|OTHER|Correlation analysis|Spearman rank correlation|0.66|||<|0.0001|TWO_SIDED|95.0|0.467|0.7964||Not adjusted for multiple comparison|Spearman rank correlation|Spearman r = 0.66 (95%CI: 0.4670 - 0.7964). Number of XY pairs: 51||Using the pooled data of all participants, we assessed temporal tracking of milk IP10 between early and mid-lactation points.||0.7964|0.4670|<0.0001
72441846|NCT03397108|144397040|SUPERIORITY|||||||0.12|||||||t-test, 2 sided|||Cognitive development at 12 months of age. Animal data suggested that pups receiving milk with lower TNF and TNF-dependent chemokines showed enhanced cognitive development. Because there was no guiding information in humans regarding milk TNF level differences between women with and without IBD, our main goal was to measure milk TNF levels. The infant cognitive/language assessment, therefore, had to be designed as a pilot and exploratory in nature.||||0.12
72441847|NCT03397108|144397040|SUPERIORITY|||||||0.56|||||||t-test, 2 sided|||Language development at 12 months of age.||||0.56
72441848|NCT03397108|144397040|SUPERIORITY|||||||0.16|||||||t-test, 2 sided|||Cognitive development at 18 months of age.||||0.16
72441849|NCT03397108|144397040|SUPERIORITY|||||||0.75|||||||t-test, 2 sided|||Language development at 18 months of age||||0.75
72441850|NCT03397108|144397040|OTHER|Correlation analysis|Spearman rank correlation|0.2655||||0.0853|TWO_SIDED|95.0|-0.047|0.5307|||Spearman rank correlation|||Using pooled data of all participants at the early-lactation sample point, correlation between milk TNF levels and 12 month cognitive development was examined to investigate if they were inversely correlated.||0.5307|-0.047|0.0853
72441851|NCT03397108|144397040|OTHER|Correlation analysis|Spearman rank correlation|0.3705||||0.09|TWO_SIDED|95.0|-0.07385|0.6921|||Spearman rank correlation|||Using the pooled data of all participants, correlation analysis between milk TNF at early lactation and 12 month language score was done to see if they were inversely correlated.||0.6921|-0.07385|0.090
72441852|NCT03397108|144397042|SUPERIORITY|||||||0.97||||||Not adjusted for multiple comparison.|Wilcoxon (Mann-Whitney)|||This is to confirm that the 2 groups are not different for their sampling time points in the early lactation period.||||0.97
72441853|NCT03397108|144397042|SUPERIORITY|||||||0.96|||||||Kruskal-Wallis|||||||0.96
72441854|NCT03397108|144397043|SUPERIORITY|||||||0.56||||||No adjustment for multiple comparison.|Wilcoxon (Mann-Whitney)|||This is to confirm that there is no difference in the second sampling time points in the mid-lactation period between the groups.||||0.56
72441855|NCT03397108|144397043|SUPERIORITY|||||||0.51|||||||Kruskal-Wallis|||||||0.51
72441856|NCT03456076|144397069|SUPERIORITY||Hazard Ratio (HR)|0.24||||0.0001|TWO_SIDED|95.0|0.13|0.45|||Log Rank|||||0.45|0.13|.0001
72441857|NCT03456076|144397069|SUPERIORITY||Hazard Ratio (HR)|0.24||||0.0001|TWO_SIDED|95.0|0.13|0.43|||Log Rank|||||0.43|0.13|.0001
72441858|NCT03990649|144397081|SUPERIORITY|||||||0.54||||||The p-values were estimated using a two-sample t-test.|t-test, 2 sided|||||||0.540
72441859|NCT00324350|144397097|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.04||||0.678|TWO_SIDED|95.0|0.86|1.27||Analyses were by intention to treat. All analyses adjusted for baseline cardiovascular disease, assignment to blood pressure (BP) trial or lipid trial, assignment to intensive BP intervention in BP trial, and assignment to fibrate in lipid trial.|Regression, Cox|||The BONE ancillary study was designed to have 80% power to detect a relative reduction in risk of non-spine clinical fractures of 22-29%. This was based on an estimated total number of fractures between 259-494, calculated with the following assumptions: rate of clinical non-spine fracture among women in the standard glycemia therapy group between 15 and 25/1000 person yrs, fracture rates for men between 35-40% of the rates for women of the same age, and an avg follow-up time of 4.6 yrs.||1.27|0.86|0.678
72441860|NCT00324350|144397098|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.1||||0.49|TWO_SIDED|95.0|0.84|1.43|||Regression, Cox|||Number of participants with falls reported at each annual visit were compared by treatment assignment using a repeated-measures negative binomial model, with robust standard errors to account for clustering of the repeated outcomes within participants; the log of the length of the reporting period varied slightly and was included as an offset||1.43|0.84|0.490
72496271|NCT04426695|144522422|SUPERIORITY|||||||0.251||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.2510
72622355|NCT00835042|144774575|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|99.1||||||90.0|96.4|102.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||102|96.4|
72387734|NCT03345914|144284020|SUPERIORITY||Percentage difference|40.4|||<|0.0001|TWO_SIDED|95.0|28.95|51.82||The Cochran-Mantel-Haenszel (CMH) test adjusted by randomization strata (baseline weight group (\< 30 kg or ≥ 30 kg) and region (North America or Europe) was used for the analysis of percentage of participants with EASI-75 at Week 16.|Cochran-Mantel-Haenszel|||A 2-sided hierarchical testing procedure was used for the primary and secondary endpoints in a pre-specified order. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level.||51.82|28.95|< 0.0001
72387735|NCT03345914|144284020|SUPERIORITY||Percentage difference|42.8|||<|0.0001|TWO_SIDED|95.0|31.54|54.15||The Cochran-Mantel-Haenszel (CMH) test adjusted by randomization strata (baseline weight group (\< 30 kg or ≥ 30 kg) and region (North America or Europe) was used for the analysis of percentage of participants with EASI-75 at Week 16.|Cochran-Mantel-Haenszel|||A 2-sided hierarchical testing procedure was used for the primary and secondary endpoints in a pre-specified order. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level.||54.15|31.54|< 0.0001
72387736|NCT03345914|144284021|SUPERIORITY||Least Square Mean Difference|-29.8|||<|0.0001|TWO_SIDED|95.0|-36.33|-23.24||The confidence interval (CI) with p-value was based on treatment difference (Dupilumab group vs placebo) of the LS mean percent change using ANCOVA model with baseline measurement as covariate and the treatment, randomization strata as fixed factors.|ANCOVA|||A 2-sided hierarchical testing procedure was used for the primary and secondary endpoints in a pre-specified order. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level.||-23.24|-36.33|< 0.0001
72387737|NCT03345914|144284021|SUPERIORITY||Least Square Mean Difference|-33.4|||<|0.0001|TWO_SIDED|95.0|-40.06|-26.82||The confidence interval (CI) with p-value was based on treatment difference (Dupilumab group vs placebo) of the LS mean percent change using ANCOVA model with baseline measurement as covariate and the treatment, randomization strata as fixed factors.|ANCOVA|||A 2-sided hierarchical testing procedure was used for the primary and secondary endpoints in a pre-specified order. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level.||-26.82|-40.06|< 0.0001
72387738|NCT03345914|144284022|SUPERIORITY||Least Square Mean Difference|-31.0|||<|0.0001|TWO_SIDED|95.0|-38.76|-23.26||The confidence interval (CI) with p-value was based on treatment difference (Dupilumab group vs placebo) of the LS mean percent change using ANCOVA model with baseline measurement as covariate and the treatment, randomization strata as fixed factors.|ANCOVA|||A 2-sided hierarchical testing procedure was used for the primary and secondary endpoints in a pre-specified order. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level.||-23.26|-38.76|< 0.0001
72387739|NCT03345914|144284022|SUPERIORITY||Least Square Mean Difference|-28.6|||<|0.0001|TWO_SIDED|95.0|-36.47|-20.82||The confidence interval (CI) with p-value was based on treatment difference (Dupilumab group vs placebo) of the LS mean percent change using ANCOVA model with baseline measurement as covariate and the treatment, randomization strata as fixed factors.|ANCOVA|||A 2-sided hierarchical testing procedure was used for the primary and secondary endpoints in a pre-specified order. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level.||-20.82|-36.47|< 0.0001
72387740|NCT03345914|144284023|SUPERIORITY||Percentage difference|46.4|||<|0.0001|TWO_SIDED|95.0|35.3|57.42||P-values were derived by Cochran-Mantel-Haenszel (CMH) test stratified by region \[North America vs Europe\] and baseline weight group \[\< 30 kg vs ≥ 30 kg\].|Cochran-Mantel-Haenszel|||A 2-sided hierarchical testing procedure was used for the primary and secondary endpoints in a pre-specified order. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level.||57.42|35.3|< 0.0001
72387741|NCT03345914|144284023|SUPERIORITY||Percentage difference|39.2|||<|0.0001|TWO_SIDED|95.0|27.88|50.51||P-values were derived by Cochran-Mantel-Haenszel (CMH) test stratified by region \[North America vs Europe\] and baseline weight group \[\< 30 kg vs ≥ 30 kg\].|Cochran-Mantel-Haenszel|||A 2-sided hierarchical testing procedure was used for the primary and secondary endpoints in a pre-specified order. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level.||50.51|27.88|< 0.0001
72387742|NCT03345914|144284024|SUPERIORITY||Percentage difference|46.0|||<|0.0001|TWO_SIDED|95.0|35.47|56.61||P-values were derived by Cochran-Mantel-Haenszel (CMH) test stratified by region \[North America vs Europe\] and baseline weight group \[\< 30 kg vs ≥ 30 kg\].|Cochran-Mantel-Haenszel|||A 2-sided hierarchical testing procedure was used for the primary and secondary endpoints in a pre-specified order. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level.||56.61|35.47|< 0.0001
72387743|NCT03345914|144284024|SUPERIORITY||Percentage difference|38.5|||<|0.0001|TWO_SIDED|95.0|27.86|49.21||P-values were derived by Cochran-Mantel-Haenszel (CMH) test stratified by region \[North America vs Europe\] and baseline weight group \[\< 30 kg vs ≥ 30 kg\].|Cochran-Mantel-Haenszel|||A 2-sided hierarchical testing procedure was used for the primary and secondary endpoints in a pre-specified order. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level.||49.21|27.86|< 0.0001
72496272|NCT04426695|144522422|SUPERIORITY|||||||0.1702||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.1702
72387744|NCT03345914|144284025|SUPERIORITY||Percentage difference|39.7|||<|0.0001|TWO_SIDED|95.0|28.68|50.72||P-values were derived by Cochran-Mantel-Haenszel (CMH) test stratified by region \[North America vs Europe\] and baseline weight group \[\< 30 kg vs ≥ 30 kg\].|Cochran-Mantel-Haenszel|||A 2-sided hierarchical testing procedure was used for the primary and secondary endpoints in a pre-specified order. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level.||50.72|28.68|< 0.0001
72387745|NCT03345914|144284025|SUPERIORITY||Percentage difference|47.9|||<|0.0001|TWO_SIDED|95.0|37.77|58.01||P-values were derived by Cochran-Mantel-Haenszel (CMH) test stratified by region \[North America vs Europe\] and baseline weight group \[\< 30 kg vs ≥ 30 kg\].|Cochran-Mantel-Haenszel|||A 2-sided hierarchical testing procedure was used for the primary and secondary endpoints in a pre-specified order. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level.||58.01|37.77|< 0.0001
72387746|NCT03345914|144284026|SUPERIORITY||Percentage difference|23.0|||<|0.0001|TWO_SIDED|95.0|13.65|32.38||P-values were derived by Cochran-Mantel-Haenszel (CMH) test stratified by region \[North America vs Europe\] and baseline weight group \[\< 30 kg vs ≥ 30 kg\].|Cochran-Mantel-Haenszel|||A 2-sided hierarchical testing procedure was used for the primary and secondary endpoints in a pre-specified order. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level.||32.38|13.65|< 0.0001
72387747|NCT03345914|144284026|SUPERIORITY||Percentage difference|34.5|||<|0.0001|TWO_SIDED|95.0|24.6|44.37||P-values were derived by Cochran-Mantel-Haenszel (CMH) test stratified by region \[North America vs Europe\] and baseline weight group \[\< 30 kg vs ≥ 30 kg\].|Cochran-Mantel-Haenszel|||A 2-sided hierarchical testing procedure was used for the primary and secondary endpoints in a pre-specified order. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level.||44.37|24.6|< 0.0001
72387748|NCT03345914|144284027|SUPERIORITY||Hazard ratios|3.114|||<|0.0001|TWO_SIDED|95.0|2.097|4.624||P-values were derived by Cochran-Mantel-Haenszel (CMH) test stratified by region \[North America vs Europe\] and baseline weight group \[\< 30 kg vs ≥ 30 kg\].|Cox model|||A 2-sided hierarchical testing procedure was used for the primary and secondary endpoints in a pre-specified order. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level.||4.624|2.097|< 0.0001
72387749|NCT03345914|144284027|SUPERIORITY||Hazard ratios|2.921|||<|0.0001|TWO_SIDED|95.0|1.957|4.36||P-values were derived by Cochran-Mantel-Haenszel (CMH) test stratified by region \[North America vs Europe\] and baseline weight group \[\< 30 kg vs ≥ 30 kg\].|Cox model|||A 2-sided hierarchical testing procedure was used for the primary and secondary endpoints in a pre-specified order. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level.||4.36|1.957|< 0.0001
72387750|NCT03345914|144284028|SUPERIORITY||Hazard ratios|2.278|||<|0.0001|TWO_SIDED|95.0|1.631|3.182||P-values were derived by Cochran-Mantel-Haenszel (CMH) test stratified by region \[North America vs Europe\] and baseline weight group \[\< 30 kg vs ≥ 30 kg\].|Cox model|||A 2-sided hierarchical testing procedure was used for the primary and secondary endpoints in a pre-specified order. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level.||3.182|1.631|< 0.0001
72387751|NCT03345914|144284028|SUPERIORITY||Hazard ratios|2.075|||<|0.0001|TWO_SIDED|95.0|1.481|2.908||P-values were derived by Cochran-Mantel-Haenszel (CMH) test stratified by region \[North America vs Europe\] and baseline weight group \[\< 30 kg vs ≥ 30 kg\].|Cox model|||A 2-sided hierarchical testing procedure was used for the primary and secondary endpoints in a pre-specified order. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level.||2.908|1.481|< 0.0001
72387752|NCT03345914|144284029|SUPERIORITY||Least Square Mean Difference|-17.72|||<|0.0001|TWO_SIDED|95.0|-22.272|-13.161||The confidence interval (CI) with p-value was based on treatment difference (Dupilumab group vs placebo) of the LS mean percent change using ANCOVA model with baseline measurement as covariate and the treatment, randomization strata as fixed factors.|ANCOVA|||A 2-sided hierarchical testing procedure was used for the primary and secondary endpoints in a pre-specified order. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level.||-13.161|-22.272|< 0.0001
72441861|NCT00324350|144397099|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.99||||0.854|TWO_SIDED|95.0|0.88|1.11|||Mixed Models Analysis||The rate of height loss did not differ between groups (p = 0.573). Height loss of \>2 cm during ACCORD was experienced by 678 (19.5%) participants in the intensive and 686 (19.6%) in the standard glycemia group (OR 0.99; 95% CI 0.88, 1.11).|Height loss was compared by treatment assignment using linear mixed models with random intercepts and slopes. The proportions losing \>2 cm of height during follow-up were compared using logistic models. Based on previous research by Siminoski et al., this degree of height loss is associated with incident vertebral fracture with 94% specificity but only 28% sensitivity.(Siminoski K, Jiang G, Adachi JD, et al. Osteoporos Int 2005;16:403-410)||1.11|0.88|0.854
72441862|NCT02015520|144397102|SUPERIORITY|||||||0.38|||||||Mixed Models Analysis|||||||0.38
72441863|NCT02015520|144397102|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
72441864|NCT02015520|144397102|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
72441865|NCT02932579|144397110|SUPERIORITY||Mean Difference (Final Values)|13.0||||0.098|TWO_SIDED||||||t-test, 2 sided|||||||0.098
72441866|NCT02932579|144397111|SUPERIORITY||Risk Ratio (RR)|1.38||||0.74|TWO_SIDED|95.0|0.45|4.21|||Fisher Exact|||||4.21|0.45|0.740
72441867|NCT02590432|144397142|SUPERIORITY||Odds Ratio (OR)|1.3||||1|TWO_SIDED|95.0|0.3|5.5|||Fisher's Exact Test|||LINZESS® 145 μg versus (vs) LINZESS® 290 μg||5.5|0.3|1.0000
72441868|NCT02590432|144397142|SUPERIORITY||Odds Ratio (OR)|0.2||||0.0844|TWO_SIDED|95.0|0.1|1.1|||Fisher's Exact Test|||LINZESS® 72 μg vs LINZESS® 290 μg||1.1|0.1|0.0844
72559331|NCT00577655|144648275|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.782||||0.1843|TWO_SIDED|95.0|-1.832|9.397||significance level of 0.05.|repeated measures ANOVA||Active - Placebo|"Day 22~A repeated measures mixed model, with terms for treatment, pooled center, study day, treatment by study day interaction, and baseline as a covariate, and subject as a random term, was used to make comparisons between placebo and active with respect to PEFmax%0-2 at Days 1 and 22, with observed case data."||9.397|-1.832|0.1843
72559332|NCT00577655|144648276|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|9.707||||0.0507|TWO_SIDED|95.0|-0.03|19.445||significance level of 0.05.|ANCOVA|terms for treatment and center, baseline as a covariate|Active - Placebo|Day 22 Baseline||19.445|-0.030|0.0507
72387753|NCT03345914|144284029|SUPERIORITY||Least Square Mean Difference|-18.88|||<|0.0001|TWO_SIDED|95.0|-23.479|-14.289||The confidence interval (CI) with p-value was based on treatment difference (Dupilumab group vs placebo) of the LS mean percent change using ANCOVA model with baseline measurement as covariate and the treatment, randomization strata as fixed factors.|ANCOVA|||A 2-sided hierarchical testing procedure was used for the primary and secondary endpoints in a pre-specified order. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level.||-14.289|-23.479|< 0.0001
72387754|NCT03345914|144284030|SUPERIORITY||Least Square Mean Difference|-30.4|||<|0.0001|TWO_SIDED|95.0|-36.3|-24.48||The confidence interval (CI) with p-value was based on treatment difference (Dupilumab group vs placebo) of the LS mean percent change using ANCOVA model with baseline measurement as covariate and the treatment, randomization strata as fixed factors.|ANCOVA|||A 2-sided hierarchical testing procedure was used for the primary and secondary endpoints in a pre-specified order. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level.||-24.48|-36.3|< 0.0001
72387755|NCT03345914|144284030|SUPERIORITY||Least Square Mean Difference|-32.6|||<|0.0001|TWO_SIDED|95.0|-38.57|-26.59||The confidence interval (CI) with p-value was based on treatment difference (Dupilumab group vs placebo) of the LS mean percent change using ANCOVA model with baseline measurement as covariate and the treatment, randomization strata as fixed factors.|ANCOVA|||A 2-sided hierarchical testing procedure was used for the primary and secondary endpoints in a pre-specified order. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level.||-26.59|-38.57|< 0.0001
72559333|NCT00577655|144648276|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.892||||0.924|TWO_SIDED|95.0|-17.634|19.419||significance level of 0.05.|ANOVA|terms for treatment and center|Active - Placebo|Day 1 Baseline||19.419|-17.634|0.9240
72559334|NCT00577655|144648277|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|30.124||||0.2186|TWO_SIDED|95.0|-18.169|78.417||significance level of 0.05.|ANCOVA|terms for treatment and center, baseline as a covariate|Active - Placebo|Day 22 Baseline||78.417|-18.169|0.2186
72387756|NCT03345914|144284031|SUPERIORITY||Least Square Mean Difference|-4.3|||<|0.0001|TWO_SIDED|95.0|-5.62|-2.99||The confidence interval (CI) with p-value was based on treatment difference (Dupilumab group vs placebo) of the LS mean percent change using ANCOVA model with baseline measurement as covariate and the treatment, randomization strata as fixed factors.|ANCOVA|||A 2-sided hierarchical testing procedure was used for the primary and secondary endpoints in a pre-specified order. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level.||-2.99|-5.62|< 0.0001
72387757|NCT03345914|144284031|SUPERIORITY||Least Square Mean Difference|-4.2|||<|0.0001|TWO_SIDED|95.0|-5.57|-2.89||The confidence interval (CI) with p-value was based on treatment difference (dupilumab group vs placebo) of the LS mean percent change using ANCOVA model with baseline measurement as covariate and the treatment, randomization strata as fixed factors.|ANCOVA|||A 2-sided hierarchical testing procedure was used for the primary and secondary endpoints in a pre-specified order. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level.||-2.89|-5.57|< 0.0001
72441869|NCT02590432|144397142|SUPERIORITY||Odds Ratio (OR)|0.9||||1|TWO_SIDED|95.0|0.3|2.5|||Fisher's Exact Test|||LINZESS® 72 μg vs LINZESS® 145 μg||2.5|0.3|1.0000
72441870|NCT02590432|144397143|SUPERIORITY||Odds Ratio (OR)|1.3||||1|TWO_SIDED|95.0|0.3|5.1|||Fisher's Exact Test|||LINZESS® 145 μg vs LINZESS® 290 μg||5.1|0.3|1.0000
72441871|NCT02590432|144397143|SUPERIORITY||Odds Ratio (OR)|0.2||||0.0799|TWO_SIDED|95.0|0.1|1.0|||Fisher's Exact Test|||LINZESS® 72 μg vs LINZESS® 290 μg||1.0|0.1|0.0799
72441872|NCT02590432|144397143|SUPERIORITY||Odds Ratio (OR)|0.7||||0.7871|TWO_SIDED|95.0|0.3|2.2|||Fisher's Exact Test|||LINZESS® 72 μg vs LINZESS® 145 μg||2.2|0.3|0.7871
72441873|NCT02590432|144397145|SUPERIORITY||Hazard Ratio (HR)|0.96||||0.993|TWO_SIDED|95.0|0.42|2.19|||Log-Rank Test|||LINZESS® 145 μg vs LINZESS® 290 μg||2.19|0.42|0.9930
72441874|NCT02590432|144397145|SUPERIORITY||Hazard Ratio (HR)|0.31||||0.0247|TWO_SIDED|95.0|0.11|0.89|||Log-Rank Test|||LINZESS® 72 μg vs LINZESS® 290 μg||0.89|0.11|0.0247
72441875|NCT02590432|144397145|SUPERIORITY||Hazard Ratio (HR)|0.79||||0.5149|TWO_SIDED|95.0|0.41|1.5|||Log-Rank Test|||LINZESS® 72 μg vs LINZESS® 145 μg||1.50|0.41|0.5149
72441876|NCT02590432|144397146|SUPERIORITY||Hazard Ratio (HR)|0.92||||0.9519|TWO_SIDED|95.0|0.39|2.18|||Log-Rank Test|||LINZESS® 145 μg vs LINZESS® 290 μg||2.18|0.39|0.9519
72441877|NCT02590432|144397146|SUPERIORITY||Hazard Ratio (HR)|0.27||||0.0234|TWO_SIDED|95.0|0.08|0.87|||Log-Rank Test|||LINZESS® 72 μg vs LINZESS® 290 μg||0.87|0.08|0.0234
72441878|NCT02590432|144397146|SUPERIORITY||Hazard Ratio (HR)|0.76||||0.4518|TWO_SIDED|95.0|0.39|1.47|||Log-Rank Test|||LINZESS® 72 μg vs LINZESS® 145 μg||1.47|0.39|0.4518
72441879|NCT03283371|144397147|SUPERIORITY||LS Mean logarithmic difference|-0.16||||0.5053|TWO_SIDED|95.0|-0.62|0.31|||Mixed Model for Repeated Measures (MMRM)|||Analysis is based on MMRM and adjusted for natural log-transformed baseline seizure frequency, high seizure frequency category (\>=24 seizures and \<24 seizures), structural etiology category (yes and no), visit, treatment and treatment by visit interaction. An unstructured variance-covariance matrix is used in the model.||0.31|-0.62|0.5053
72441880|NCT03283371|144397148|SUPERIORITY||Odds Ratio (OR)|2.09||||0.2231|TWO_SIDED|95.0|0.64|6.85|||Regression, Logistic|||Based on logistic regression with a term for treatment group and with adjustment for natural log-transformed baseline seizure frequency, high seizure frequency category (\>=24 seizures and \<24 seizures) and structural etiology category (yes and no).||6.85|0.64|0.2231
72559335|NCT00577655|144648277|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|42.578||||0.2375|TWO_SIDED|95.0|-28.541|113.7||significance level of 0.05.|ANCOVA|terms for treatment and center, baseline as a covariate|Active - Placebo|Day 1 Baseline||113.70|-28.541|0.2375
72441881|NCT03283371|144397151|SUPERIORITY||Odds Ratio (OR)|0.67||||0.6854|TWO_SIDED|95.0|0.1|4.57|||Regression, Logistic|||Based on the logistic regression model with a term for treatment group and with adjustment for log-transformed baseline seizure frequency, high seizure frequency category (\>=24 seizures and \<24 seizures) and structural etiology category (yes and no) are considered as covariates.||4.57|0.10|0.6854
72441882|NCT00999167|144397200|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0354|TWO_SIDED|95.0|||||Poisson regression adjusting for country|||||||0.0354
72441883|NCT00999167|144397201|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0214||95.0|||||Cochran-Mantel-Haenszel|||||||0.0214
72441884|NCT00999167|144397202|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.56||||0.047||95.0|||||Regression, Cox|||||||0.047
72441885|NCT00999167|144397203|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0713|TWO_SIDED|95.0|||||ANCOVA|||Changes in the Total Index Score from Baseline and Day 56.||||0.0713
72559336|NCT00577655|144648278|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|6.524||||0.0017|TWO_SIDED|95.0|2.524|10.523||significance level of 0.05.|ANOVA|terms for treatment, center, time, time x treatment, subject as a random|Active - Placebo|Day 1||10.523|2.524|0.0017
72387758|NCT03345914|144284032|SUPERIORITY||Least Square Mean Difference|-8.1|||<|0.0001|TWO_SIDED|95.0|-9.96|-6.31||The confidence interval (CI) with p-value was based on treatment difference (Dupilumab group vs placebo) of the LS mean percent change using ANCOVA model with baseline measurement as covariate and the treatment, randomization strata as fixed factors.|ANCOVA|||A 2-sided hierarchical testing procedure was used for the primary and secondary endpoints in a pre-specified order. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level.||-6.31|-9.96|< 0.0001
72387759|NCT03345914|144284032|SUPERIORITY||Least Square Mean Difference|-8.3|||<|0.0001|TWO_SIDED|95.0|-10.13|-6.43||The confidence interval (CI) with p-value was based on treatment difference (Dupilumab group vs placebo) of the LS mean percent change using ANCOVA model with baseline measurement as covariate and the treatment, randomization strata as fixed factors.|ANCOVA|||A 2-sided hierarchical testing procedure was used for the primary and secondary endpoints in a pre-specified order. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level.||-6.43|-10.13|< 0.0001
72387760|NCT03345914|144284033|SUPERIORITY||Least Square Mean Difference|-2.41|||<|0.0001|TWO_SIDED|95.0|-2.984|-1.831||The confidence interval (CI) with p-value was based on treatment difference (Dupilumab group vs placebo) of the LS mean percent change using ANCOVA model with baseline measurement as covariate and the treatment, randomization strata as fixed factors.|ANCOVA|||A 2-sided hierarchical testing procedure was used for the primary and secondary endpoints in a pre-specified order. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level.||-1.831|-2.984|< 0.0001
72441886|NCT00999167|144397203|SUPERIORITY_OR_OTHER_LEGACY|||||||0.252|TWO_SIDED|95.0|||||ANCOVA|||Changes in the Total Index Score from Baseline and the Final Visit.||||0.2520
72441887|NCT02554786|144397204|SUPERIORITY||Least Square mean (LS Mean)|0.132|STANDARD_ERROR_OF_MEAN|0.0223|<|0.001|TWO_SIDED|95.0|0.088|0.176|||Mixed Model for Repeated Measures (MMRM)|||||0.176|0.088|<0.001
72441888|NCT02554786|144397204|SUPERIORITY||LS Mean|0.211|STANDARD_ERROR_OF_MEAN|0.0224|<|0.001|TWO_SIDED|95.0|0.167|0.255|||MMRM|||||0.255|0.167|<0.001
72441889|NCT02554786|144397205|SUPERIORITY||LS Mean|-0.172|STANDARD_ERROR_OF_MEAN|0.0415|<|0.001|TWO_SIDED|95.0|-0.254|-0.091|||MMRM|||Week 4||-0.091|-0.254|<0.001
72441890|NCT02554786|144397205|SUPERIORITY||LS Mean|-0.196|STANDARD_ERROR_OF_MEAN|0.0416|<|0.001|TWO_SIDED|95.0|-0.278|-0.115|||MMRM|||Week 4||-0.115|-0.278|<0.001
72441891|NCT02554786|144397205|SUPERIORITY||LS Mean|-0.055|STANDARD_ERROR_OF_MEAN|0.0414||0.186|TWO_SIDED|95.0|-0.136|0.026|||MMRM|||Week 4||0.026|-0.136|0.186
72441892|NCT02554786|144397205|SUPERIORITY||LS Mean|-0.184|STANDARD_ERROR_OF_MEAN|0.0294|<|0.001|TWO_SIDED|95.0|-0.242|-0.127|||MMRM|||Week 4: The comparison of QMF149 vs. MF was based on combined effects of QMF149 150/160 \& 150/320 μg and MF 400 \& 800 μg derived by weighting treatment groups equally.||-0.127|-0.242|<0.001
72441893|NCT02554786|144397205|SUPERIORITY||LS Mean|-0.129|STANDARD_ERROR_OF_MEAN|0.0431||0.003|TWO_SIDED|95.0|-0.214|-0.044|||MMRM|||Week 12||-0.044|-0.214|0.003
72441894|NCT02554786|144397205|SUPERIORITY||LS Mean|-0.248|STANDARD_ERROR_OF_MEAN|0.0435|<|0.001|TWO_SIDED|95.0|-0.333|-0.162|||MMRM|||Week 12||-0.162|-0.333|<0.001
72441895|NCT02554786|144397205|SUPERIORITY||LS Mean|-0.052|STANDARD_ERROR_OF_MEAN|0.0431||0.232|TWO_SIDED|95.0|-0.136|0.033|||MMRM|||Week 12||0.033|-0.136|0.232
72441896|NCT02554786|144397205|SUPERIORITY||LS Mean|-0.188|STANDARD_ERROR_OF_MEAN|0.0307|<|0.001|TWO_SIDED|95.0|-0.248|-0.128|||MMRM|||Week 12: The comparison of QMF149 vs. MF was based on combined effects of QMF149 150/160 \& 150/320 μg and MF 400 \& 800 μg derived by weighting treatment groups equally.||-0.128|-0.248|<0.001
72441897|NCT02554786|144397205|SUPERIORITY||LS Mean|-0.171|STANDARD_ERROR_OF_MEAN|0.0437|<|0.001|TWO_SIDED|95.0|-0.257|-0.086|||MMRM|||Week 26||-0.086|-0.257|<0.001
72441898|NCT02554786|144397205|SUPERIORITY||LS Mean|-0.248|STANDARD_ERROR_OF_MEAN|0.0439|<|0.001|TWO_SIDED|95.0|-0.334|-0.162|||MMRM|||Week 26||-0.162|-0.334|<0.001
72441899|NCT02554786|144397205|SUPERIORITY||LS Mean|-0.054|STANDARD_ERROR_OF_MEAN|0.0437||0.214|TWO_SIDED|95.0|-0.14|0.031|||MMRM|||Week 26||0.031|-0.140|0.214
72441900|NCT02554786|144397205|SUPERIORITY||LS Mean|-0.209|STANDARD_ERROR_OF_MEAN|0.031|<|0.001|TWO_SIDED|95.0|-0.27|-0.149|||MMRM|||Week 26: The comparison of QMF149 vs. MF was based on combined effects of QMF149 150/160 \& 150/320 μg and MF 400 \& 800 μg derived by weighting treatment groups equally.||-0.149|-0.270|<0.001
72441901|NCT02554786|144397205|SUPERIORITY||LS Mean|-0.141|STANDARD_ERROR_OF_MEAN|0.0449||0.002|TWO_SIDED|95.0|-0.229|-0.053|||MMRM|||Week 52||-0.053|-0.229|0.002
72559337|NCT00577655|144648278|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.998||||0.0521|TWO_SIDED|95.0|-0.037|8.032||significance level of 0.05.|ANOVA|terms for treatment, center, time, time x treatment, subject as a random|Active - Placebo|Day 22||8.032|-0.037|0.0521
72441902|NCT02554786|144397205|SUPERIORITY||LS Mean|-0.266|STANDARD_ERROR_OF_MEAN|0.045|<|0.001|TWO_SIDED|95.0|-0.354|-0.177|||MMRM|||Week 52||-0.177|-0.354|<0.001
72441903|NCT02554786|144397205|SUPERIORITY||LS Mean|0.01|STANDARD_ERROR_OF_MEAN|0.0447||0.824|TWO_SIDED|95.0|-0.078|0.098|||MMRM|||Week 52||0.098|-0.078|0.824
72441904|NCT02554786|144397205|SUPERIORITY||LS Mean|-0.203|STANDARD_ERROR_OF_MEAN|0.0318|<|0.001|TWO_SIDED|95.0|-0.266|-0.141|||MMRM|||Week 52: The comparison of QMF149 vs. MF was based on combined effects of QMF149 150/160 \& 150/320 μg and MF 400 \& 800 μg derived by weighting treatment groups equally.||-0.141|-0.266|<0.001
72441905|NCT02554786|144397206|SUPERIORITY||LS Mean|0.136|STANDARD_ERROR_OF_MEAN|0.0235|<|0.001|TWO_SIDED|95.0|0.09|0.183|||MMRM|||||0.183|0.090|<0.001
72441906|NCT02554786|144397206|SUPERIORITY||LS Mean|0.209|STANDARD_ERROR_OF_MEAN|0.0235|<|0.001|TWO_SIDED|95.0|0.163|0.255|||MMRM|||||0.255|0.163|<0.001
72441907|NCT02554786|144397206|SUPERIORITY||LS Mean|0.048|STANDARD_ERROR_OF_MEAN|0.0234||0.04|TWO_SIDED|95.0|0.002|0.094|||MMRM|||||0.094|0.002|0.04
72441908|NCT02554786|144397207|SUPERIORITY||LS Mean|0.132|STANDARD_ERROR_OF_MEAN|0.0193|<|0.001|TWO_SIDED|95.0|0.094|0.17|||MMRM|||Day 30||0.170|0.094|<0.001
72441909|NCT02554786|144397207|SUPERIORITY||LS Mean|0.196|STANDARD_ERROR_OF_MEAN|0.0194|<|0.001|TWO_SIDED|95.0|0.158|0.234|||MMRM|||Day 30||0.234|0.158|<0.001
72559338|NCT00577655|144648279|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|1.477||||0.0647|TWO_SIDED|95.0|0.98|2.23||significance level of 0.05.|Regression, Cox||Active/Placebo|Day 1||2.23|0.98|0.0647
72559339|NCT00577655|144648279|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|2.088||||0.0005|TWO_SIDED|95.0|1.38|3.15||significance level of 0.05.|Regression, Cox||Active/Placebo|Day 22||3.15|1.38|0.0005
72559340|NCT00577655|144648280|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|1.141||||0.5059|TWO_SIDED|95.0|0.77|1.69||significance level of 0.05.|Regression, Cox||Active/Placebo|Day 1||1.69|0.77|0.5059
72441910|NCT02554786|144397207|SUPERIORITY||LS Mean|0.035|STANDARD_ERROR_OF_MEAN|0.0192||0.064|TWO_SIDED|95.0|-0.002|0.073|||MMRM|||Day 30||0.073|-0.002|0.064
72441911|NCT02554786|144397207|SUPERIORITY||LS Mean|0.122|STANDARD_ERROR_OF_MEAN|0.0201|<|0.001|TWO_SIDED|95.0|0.083|0.162|||MMRM|||Day 86||0.162|0.083|<0.001
72441912|NCT02554786|144397207|SUPERIORITY||LS Mean|0.184|STANDARD_ERROR_OF_MEAN|0.0202|<|0.001|TWO_SIDED|95.0|0.144|0.224|||MMRM|||Day 86||0.224|0.144|<0.001
72441913|NCT02554786|144397207|SUPERIORITY||LS Mean|0.037|STANDARD_ERROR_OF_MEAN|0.02||0.063|TWO_SIDED|95.0|-0.002|0.076|||MMRM|||Day 86||0.076|-0.002|0.063
72441914|NCT02554786|144397208|SUPERIORITY||LS Mean|0.142|STANDARD_ERROR_OF_MEAN|0.0116|<|0.001|TWO_SIDED|95.0|0.119|0.164|||MMRM|||Day 1: 5 minutes||0.164|0.119|<0.001
72441915|NCT02554786|144397208|SUPERIORITY||LS Mean|0.152|STANDARD_ERROR_OF_MEAN|0.0116|<|0.001|TWO_SIDED|95.0|0.129|0.175|||MMRM|||Day 1: 5 minutes||0.175|0.129|<0.001
72441916|NCT02554786|144397208|SUPERIORITY||LS Mean|0.055|STANDARD_ERROR_OF_MEAN|0.0116|<|0.001|TWO_SIDED|95.0|0.032|0.078|||MMRM|||Day 1: 5 minutes||0.078|0.032|<0.001
72441917|NCT02554786|144397208|SUPERIORITY||LS Mean|0.162|STANDARD_ERROR_OF_MEAN|0.0122|<|0.001|TWO_SIDED|95.0|0.138|0.186|||MMRM|||Day 1: 15 minutes||0.186|0.138|<0.001
72441918|NCT02554786|144397208|SUPERIORITY||LS mean|0.174|STANDARD_ERROR_OF_MEAN|0.0123|<|0.001|TWO_SIDED|95.0|0.15|0.198|||MMRM|||Day 1: 15 minutes||0.198|0.150|<.001
72441919|NCT02554786|144397208|SUPERIORITY||LS Mean|0.044|STANDARD_ERROR_OF_MEAN|0.0122|<|0.001|TWO_SIDED|95.0|0.02|0.068|||MMRM|||Day1: 15 minutes||0.068|0.02|<0.001
72441920|NCT02554786|144397208|SUPERIORITY||LS Mean|0.175|STANDARD_ERROR_OF_MEAN|0.0132|<|0.001|TWO_SIDED|95.0|0.149|0.201|||MMRM|||Day 1: 30 minutes||0.201|0.149|<0.001
72441921|NCT02554786|144397208|SUPERIORITY||LS Mean|0.185|STANDARD_ERROR_OF_MEAN|0.0132|<|0.001|TWO_SIDED|95.0|0.159|0.211|||MMRM|||Day 1: 30 minutes||0.211|0.159|<0.001
72441922|NCT02554786|144397208|SUPERIORITY||LS Mean|0.027|STANDARD_ERROR_OF_MEAN|0.0132||0.038|TWO_SIDED|95.0|0.001|0.053|||MMRM|||Day 1: 30 minutes||0.053|0.001|0.038
72441923|NCT02554786|144397208|SUPERIORITY||LS Mean|0.178|STANDARD_ERROR_OF_MEAN|0.0139|<|0.001|TWO_SIDED|95.0|0.15|0.205|||MMRM|||Day 1: 1 hour||0.205|0.150|<0.001
72441924|NCT02554786|144397208|SUPERIORITY||LS Mean|0.205|STANDARD_ERROR_OF_MEAN|0.0139|<|0.001|TWO_SIDED|95.0|0.177|0.232|||MMRM|||Day 1: 1hour||0.232|0.177|<0.001
72441925|NCT02554786|144397208|SUPERIORITY||LS Mean|0.007|STANDARD_ERROR_OF_MEAN|0.0139||0.632|TWO_SIDED|95.0|-0.021|0.034|||MMRM|||Day 1: 1hour||0.034|-0.021|0.632
72441926|NCT02554786|144397208|SUPERIORITY||LS Mean|0.189|STANDARD_ERROR_OF_MEAN|0.0192|<|0.001|TWO_SIDED|95.0|0.151|0.226|||MMRM|||Day 30: 5 minutes||0.226|0.151|<0.001
72441927|NCT02554786|144397208|SUPERIORITY||LS Mean|0.232|STANDARD_ERROR_OF_MEAN|0.0194|<|0.001|TWO_SIDED|95.0|0.194|0.27|||MMRM|||Day 30: 5 minutes||0.270|0.194|<0.001
72441928|NCT02554786|144397208|SUPERIORITY||LS Mean|0.053|STANDARD_ERROR_OF_MEAN|0.0191||0.005|TWO_SIDED|95.0|0.016|0.091|||MMRM|||Day 30: 5 minutes||0.091|0.016|0.005
72441929|NCT02554786|144397208|SUPERIORITY||LS Mean|0.194|STANDARD_ERROR_OF_MEAN|0.0194|<|0.001|TWO_SIDED|95.0|0.156|0.232|||MMRM|||Day 30: 30 minutes||0.232|0.156|<0.001
72441930|NCT02554786|144397208|SUPERIORITY||LS Mean|0.253|STANDARD_ERROR_OF_MEAN|0.0196|<|0.001|TWO_SIDED|95.0|0.214|0.291|||MMRM|||Day 30: 30 minutes||0.291|0.214|<0.001
72441931|NCT02554786|144397208|SUPERIORITY||LS Mean|0.043|STANDARD_ERROR_OF_MEAN|0.0192||0.026|TWO_SIDED|95.0|0.005|0.08|||MMRM|||Day 30: 30 minutes||0.08|0.005|0.026
72441932|NCT02554786|144397208|SUPERIORITY||LS Mean|0.19|STANDARD_ERROR_OF_MEAN|0.0196|<|0.001|TWO_SIDED|95.0|0.152|0.229|||MMRM|||Day 30: 1 hour||0.229|0.152|<0.001
72441933|NCT02554786|144397208|SUPERIORITY||LS Mean|0.258|STANDARD_ERROR_OF_MEAN|0.0198|<|0.001|TWO_SIDED|95.0|0.219|0.296|||MMRM|||Day 30: 1 hour||0.296|0.219|<0.001
72441934|NCT02554786|144397208|SUPERIORITY||LS Mean|0.037|STANDARD_ERROR_OF_MEAN|0.0194||0.059|TWO_SIDED|95.0|-0.001|0.075|||MMRM|||Day 30: 1 hour||0.075|-0.001|0.059
72441935|NCT02554786|144397208|SUPERIORITY||LS Mean|0.163|STANDARD_ERROR_OF_MEAN|0.0204|<|0.001|TWO_SIDED|95.0|0.123|0.203|||MMRM|||Day 86: 5 minutes||0.203|0.123|<0.001
72559341|NCT00577655|144648280|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|1.533||||0.0333|TWO_SIDED|95.0|1.03|2.27||significance level of 0.05.|Regression, Cox||Active/Placebo|Day 22||2.27|1.03|0.0333
72559342|NCT00577655|144648281|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3888||||||significance level of 0.05.|Fisher Exact|||Day 1||||0.3888
72559343|NCT00577655|144648281|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1249||||||significance level of 0.05.|Fisher Exact|||Day 22||||0.1249
72559344|NCT00577655|144648282|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0343||||||significance level of 0.05.|Fisher Exact|||Day 1||||0.0343
72559345|NCT00577655|144648282|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0962||||||significance level of 0.05.|Fisher Exact|||Day 22||||0.0962
72559346|NCT00577655|144648283|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0109||||||significance level of 0.05.|Fisher Exact|||Day 1||||0.0109
72559347|NCT00577655|144648283|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0845||||||significance level of 0.05.|Fisher Exact|||Day 22||||0.0845
72622356|NCT00835042|144774576|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|99.3||||||90.0|96.7|102.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||102|96.7|
72387761|NCT03345914|144284033|SUPERIORITY||Least Square Mean Difference|-2.18|||<|0.0001|TWO_SIDED|95.0|-2.754|-1.599||The confidence interval (CI) with p-value was based on treatment difference (Dupilumab group vs placebo) of the LS mean percent change using ANCOVA model with baseline measurement as covariate and the treatment, randomization strata as fixed factors.|ANCOVA|||A 2-sided hierarchical testing procedure was used for the primary and secondary endpoints in a pre-specified order. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level.||-1.599|-2.754|< 0.0001
72387762|NCT03345914|144284034|SUPERIORITY||Least Square Mean Difference|-4.11|||<|0.0001|TWO_SIDED|95.0|-5.434|-2.796||The confidence interval (CI) with p-value was based on treatment difference (Dupilumab group vs placebo) of the LS mean percent change using ANCOVA model with baseline measurement as covariate and the treatment, randomization strata as fixed factors.|ANCOVA|||A 2-sided hierarchical testing procedure was used for the primary and secondary endpoints in a pre-specified order. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level.||-2.796|-5.434|< 0.0001
72387763|NCT03345914|144284034|SUPERIORITY||Least Square Mean Difference|-3.98|||<|0.0001|TWO_SIDED|95.0|-5.298|-2.657||The confidence interval (CI) with p-value was based on treatment difference (Dupilumab group vs placebo) of the LS mean percent change using ANCOVA model with baseline measurement as covariate and the treatment, randomization strata as fixed factors.|ANCOVA|||A 2-sided hierarchical testing procedure was used for the primary and secondary endpoints in a pre-specified order. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level.||-2.657|-5.298|< 0.0001
72387764|NCT03345914|144284035|SUPERIORITY||Least Square Mean Difference|-3.37|||=|0.0061|TWO_SIDED|95.0|-5.779|-0.962||The confidence interval (CI) with p-value was based on treatment difference (Dupilumab group vs placebo) of the LS mean percent change using ANCOVA model with baseline measurement as covariate and the treatment, randomization strata as fixed factors.|ANCOVA|||A 2-sided hierarchical testing procedure was used for the primary and secondary endpoints in a pre-specified order. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level.||-0.962|-5.779|= 0.0061
72387765|NCT03345914|144284035|SUPERIORITY||Least Square Mean Difference|-3.02|||=|0.0133|TWO_SIDED|95.0|-5.414|-0.629||The confidence interval (CI) with p-value was based on treatment difference (Dupilumab group vs placebo) of the LS mean percent change using ANCOVA model with baseline measurement as covariate and the treatment, randomization strata as fixed factors.|ANCOVA|||A 2-sided hierarchical testing procedure was used for the primary and secondary endpoints in a pre-specified order. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level.||-0.629|-5.414|= 0.0133
72387766|NCT03345914|144284036|SUPERIORITY||Least Square Mean Difference|-4.5|||<|0.0001|TWO_SIDED|95.0|-6.734|-2.272||The confidence interval (CI) with p-value was based on treatment difference (Dupilumab group vs placebo) of the LS mean percent change using ANCOVA model with baseline measurement as covariate and the treatment, randomization strata as fixed factors.|ANCOVA|||A 2-sided hierarchical testing procedure was used for the primary and secondary endpoints in a pre-specified order. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level.||-2.272|-6.734|< 0.0001
72441936|NCT02554786|144397208|SUPERIORITY||LS Mean|0.231|STANDARD_ERROR_OF_MEAN|0.0206|<|0.001|TWO_SIDED|95.0|0.191|0.271|||MMRM|||Day 86: 5 minutes||0.271|0.191|<0.001
72441937|NCT02554786|144397208|SUPERIORITY||LS Mean|0.055|STANDARD_ERROR_OF_MEAN|0.0203||0.007|TWO_SIDED|95.0|0.015|0.095|||MMRM|||Day 86: 5minutes||0.095|0.015|0.007
72441938|NCT02554786|144397208|SUPERIORITY||LS Mean|0.18|STANDARD_ERROR_OF_MEAN|0.0203|<|0.001|TWO_SIDED|95.0|0.14|0.219|||MMRM|||Day 86: 30 minutes||0.219|0.140|<0.001
72441939|NCT02554786|144397208|SUPERIORITY||LS Mean|0.252|STANDARD_ERROR_OF_MEAN|0.0205|<|0.001|TWO_SIDED|95.0|0.211|0.292|||MMRM|||Day 86: 30 minutes||0.292|0.211|<0.001
72441940|NCT02554786|144397208|SUPERIORITY||LS Mean|0.038|STANDARD_ERROR_OF_MEAN|0.0202||0.057|TWO_SIDED|95.0|-0.001|0.078|||MMRM|||Day 86: 30 minutes||0.078|-0.001|0.057
72559348|NCT00577655|144648284|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0013||||||significance level of 0.05.|Fisher Exact|||Day 1||||0.0013
72559349|NCT00577655|144648284|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0085||||||significance level of 0.05.|Fisher Exact|||Day 22||||0.0085
72559350|NCT00577655|144648285|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.072||||0.4674|TWO_SIDED|95.0|-0.265|0.122||significance level of 0.05.|ANCOVA|terms for treatment, center, week, week by treatment, baseline as a covariate, subject as random.|Active - Placebo|Week 1||0.122|-0.265|0.4674
72559351|NCT00577655|144648285|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.171||||0.084|TWO_SIDED|95.0|-0.365|0.023||significance level of 0.05.|ANCOVA|terms for treatment, center, week, week by treatment, baseline as covariate, subject as random|Active - Placebo|Week 2||0.023|-0.365|0.0840
72387767|NCT03345914|144284036|SUPERIORITY||Least Square Mean Difference|-5.42|||<|0.0001|TWO_SIDED|95.0|-7.641|-3.207||The confidence interval (CI) with p-value was based on treatment difference (Dupilumab group vs placebo) of the LS mean percent change using ANCOVA model with baseline measurement as covariate and the treatment, randomization strata as fixed factors.|ANCOVA|||A 2-sided hierarchical testing procedure was used for the primary and secondary endpoints in a pre-specified order. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level.||-3.207|-7.641|< 0.0001
72387768|NCT03345914|144284037|SUPERIORITY||Percentage Differenece|-4.8|||=|0.222|TWO_SIDED|95.0|-12.49|2.87||P-values were derived by Cochran-Mantel-Haenszel (CMH) test stratified by region \[North America vs Europe\] and baseline weight group \[\< 30 kg vs ≥ 30 kg\].|Cochran-Mantel-Haenszel|||A 2-sided hierarchical testing procedure was used for the primary and secondary endpoints in a pre-specified order. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level.||2.87|-12.49|= 0.222
72387769|NCT03345914|144284037|SUPERIORITY||Percentage Differenece|-7.3|||=|0.0508|TWO_SIDED|95.0|-14.51|-0.03||P-values were derived by Cochran-Mantel-Haenszel (CMH) test stratified by region \[North America vs Europe\] and baseline weight group \[\< 30 kg vs ≥ 30 kg\].|Cochran-Mantel-Haenszel|||A 2-sided hierarchical testing procedure was used for the primary and secondary endpoints in a pre-specified order. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level.||-0.03|-14.51|= 0.0508
72387770|NCT03345914|144284040|SUPERIORITY||Least Square Mean Difference|-5.7|||=|0.003|TWO_SIDED|95.0|-9.49|-1.96||The confidence interval (CI) with p-value was based on treatment difference (Dupilumab group vs placebo) of the LS mean percent change using ANOVA model with the treatment, randomization strata as fixed factors.|ANOVA|||A 2-sided hierarchical testing procedure was used for the primary and secondary endpoints in a pre-specified order. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level||-1.96|-9.49|= 0.003
72387771|NCT03345914|144284040|SUPERIORITY|A 2-sided hierarchical testing procedure was used for the primary and secondary endpoints in a pre-specified order. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level|Least Square Mean Difference|-5.1|||=|0.0082|TWO_SIDED|95.0|-8.8|-1.31||The confidence interval (CI) with p-value was based on treatment difference (Dupilumab group vs placebo) of the LS mean percent change using ANOVA model with the treatment, randomization strata as fixed factors.|ANOVA|||||-1.31|-8.8|= 0.0082
72387772|NCT01952145|144284098|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority of IDegLira versus IGlar was considered as confirmed, if the 95% confidence interval (CI) for the mean treatment difference was entirely below 0.30%.|Treatment contrast|-0.59|||<|0.001|TWO_SIDED|95.0|-0.74|-0.45|||ANCOVA|||This primary endpoint was analysed on the FAS using an ANCOVA model with treatment and region as fixed effects and baseline HbA1c value as covariate.||-0.45|-0.74|< 0.001
72387773|NCT03758066|144284105|OTHER|||||||0.03||||||P-value reported for quality of life measured between baseline and 12-month follow-up with a statistical significance threshold of .05.|Sign test|||A two-tailed non-parametric one-sample paired sign test was used to determine whether to reject or fail to reject the null hypothesis that the mean difference of scores between any of the 2 of 3 timepoints is 0 (Baseline v. 6-month, 6-month v. 12-month, and Baseline v. 12-month).||||.03
72387774|NCT03758066|144284106|SUPERIORITY|||||||0.02||||||P-value reported for self-reported self-efficacy in chronic disease management between baseline and 12-month follow-up with a statistical significance threshold of .05.|Sign test|||A two-tailed non-parametric one-sample paired sign test was used to determine whether to reject or fail to reject the null hypothesis that the mean difference of scores between any of the 2 of 3 timepoints is 0 (Baseline v. 6-month, 6-month v. 12-month, and Baseline v. 12-month).||||.02
72387775|NCT03758066|144284106|OTHER|||||||0.02||||||P-value reported for self-reported self-efficacy in chronic disease management between 6- and 12-month follow-up with a statistical significance threshold of .05.|Sign test|||||||.02
72387776|NCT04138810|144284109|NON_INFERIORITY|We defined the non-inferiority margin to be 5 points which with a sample of size of 25 women per arm would mean we would have a type I error rate of 0.05 and a power of 0.80.|Mean Difference (Net)|0.46|||||TWO_SIDED|95.0|-1.95|1.03||||||||1.03|-1.95|
72387777|NCT00762385|144284112|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.03164|STANDARD_ERROR_OF_MEAN|0.1247||||98.3|-0.2346|0.03164|||Mixed Models Analysis||Mean difference is galyfilcon A minus comfilcon A.|Results is overall lens effect with time as a covariate.||0.03164|-0.2346|
72387778|NCT00762385|144284113|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.00556|STANDARD_ERROR_OF_MEAN|0.02287||||98.3|-0.04297|0.00556|||Mixed Models Analysis||Mean difference is galyfilcon A minus comfilcon A.|Results is overall lens effect with time as a covariate.||0.005560|-0.04297|
72387779|NCT00762385|144284114|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2726|STANDARD_ERROR_OF_MEAN|0.1064||||98.3|0.04553|0.2726|||Mixed Models Analysis||Mean difference is galyfilcon A minus comfilcon A.|Results is overall lens effect with time as a covariate.||0.2726|0.04553|
72387780|NCT03863197|144284152|SUPERIORITY||||||<|0.01|TWO_SIDED|95.0||||The α-level was adjusted to p ≤ 0.01 since multiple parameters were evaluated for most research questions, with a maximum of 5 parameters (functional strength)|Mixed Models Analysis|||||||<0.01
72387781|NCT03863197|144284153|SUPERIORITY||||||<|0.01|TWO_SIDED|95.0||||The α-level was adjusted to p ≤ 0.01 since multiple parameters were evaluated for most research questions, with a maximum of 5 parameters (functional strength)|Mixed Models Analysis|||||||<0.01
72387782|NCT03863197|144284154|SUPERIORITY||||||<|0.01|TWO_SIDED|95.0||||The α-level was adjusted to p ≤ 0.01 since multiple parameters were evaluated for most research questions, with a maximum of 5 parameters (functional strength)|Mixed Models Analysis|||||||<0.01
72387783|NCT03863197|144284155|SUPERIORITY||||||<|0.01||||||The α-level was adjusted to p ≤ 0.01 since multiple parameters were evaluated for most research questions, with a maximum of 5 parameters (functional strength)|Mixed Models Analysis|||||||<0.01
72387784|NCT03863197|144284156|SUPERIORITY||||||<|0.01|TWO_SIDED|95.0||||The α-level was adjusted to p ≤ 0.01 since multiple parameters were evaluated for most research questions, with a maximum of 5 parameters (functional strength)|Mixed Models Analysis|||||||<0.01
72387785|NCT03863197|144284157|SUPERIORITY||||||<|0.01||||||The α-level was adjusted to p ≤ 0.01 since multiple parameters were evaluated for most research questions, with a maximum of 5 parameters (functional strength)|Mixed Models Analysis|||||||<0.01
72387786|NCT03863197|144284161|SUPERIORITY||||||<|0.01|TWO_SIDED|95.0||||The α-level was adjusted to p ≤ 0.01 since multiple parameters were evaluated for most research questions, with a maximum of 5 parameters (functional strength)|Mixed Models Analysis|||||||<0.01
72387787|NCT03863197|144284162|SUPERIORITY||||||<|0.01|TWO_SIDED|95.0||||The α-level was adjusted to p ≤ 0.01 since multiple parameters were evaluated for most research questions, with a maximum of 5 parameters (functional strength)|Mixed Models Analysis|||||||<0.01
72387788|NCT05338216|144284163|SUPERIORITY||Mean Difference (Final Values)|19.63||||0.021||95.0|4.37|36.24||Threshold for significance: p \< 0.05. No correction for multiple comparisons performed due to only two tests conducted and exploratory nature of this pilot study.|Wilcoxon (Mann-Whitney)|||Hypothesis: Compliance would be significantly higher for micro-interaction based versus traditional EMA. Null hypothesis: No difference between conditions.||36.24|4.37|0.021
72387789|NCT05338216|144284164|SUPERIORITY||Mean Difference (Final Values)|17.34||||0.027||95.0|0.78|32.77||Threshold for significance: p \< 0.05. No correction for multiple comparisons performed due to only two tests conducted and exploratory nature of this pilot study.|Wilcoxon (Mann-Whitney)|||Hypothesis: Completion would be significantly higher for micro-interaction based versus traditional EMA. Null hypothesis: No difference between conditions.||32.77|0.78|0.027
72387790|NCT02498132|144284167|OTHER|A generalized estimating equation (GEE) model assuming a normal distribution, identity link function, and exchangeable correlation matrix was used to examine the interaction between time and treatment condition on BDI-II depressive symptoms adjusting for the main effects of baseline depressive symptoms, time, and treatment condition.|||||<|0.05|||||||Chi-squared|||||||<.05
72387791|NCT01065597|144284180|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|TWO_SIDED||||||t-test, 2 sided|This was a paired t-test.||||||0.001
72387792|NCT01065597|144284181|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|TWO_SIDED||||||t-test, 2 sided|This was a paired t-test.||||||>0.05
72387793|NCT01065597|144284183|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||>0.05
72387794|NCT02653872|144284196|NON_INFERIORITY_OR_EQUIVALENCE|Geometric mean ratio of Cmax for AZD7986 administered with verapamil over Cmax for AZD7986 administered alone. Presented as a percentage.|% Geometric Mean Ratio|153.4|||||TWO_SIDED|90.0|136.16|172.83|||ANOVA|||The study was designed based on a test for bioequivalence. Using an estimated standard deviation for Cmax of AZD7986 of less than or equal to 0.202, 12 evaluable subjects were deemed needed to achieve a power of 90%, at an assumed ratio of 0.95, to show that a two-sided 90% confidence interval for the ratio of Cmax between 2 treatments (AZD7986 and AZD7986+ Verapamil/Itraconazole) would be contained within the (0.8;1.25) equivalence limit. 3 extra subjects were added to compensate for dropout.||172.83|136.16|
72387795|NCT02653872|144284196|NON_INFERIORITY_OR_EQUIVALENCE|Geometric mean ratio of Cmax for AZD7986 administered with itraconazole over Cmax for AZD7986 administered alone. Presented as a percentage.|% Geometric Mean Ratio|60.66|||||TWO_SIDED|90.0|53.84|68.34|||ANOVA|||The study was designed based on a test for bioequivalence. Using an estimated standard deviation for Cmax of AZD7986 of less than or equal to 0.202, 12 evaluable subjects were deemed needed to achieve a power of 90%, at an assumed ratio of 0.95, to show that a two-sided 90% confidence interval for the ratio of Cmax between 2 treatments (AZD7986 and AZD7986+ Verapamil/Itraconazole) would be contained within the (0.8;1.25) equivalence limit. 3 extra subjects were added to compensate for dropout.||68.34|53.84|
72387796|NCT02653872|144284197|NON_INFERIORITY_OR_EQUIVALENCE|Geometric mean ratio of AUC for AZD7986 administered with verapamil over AUC for AZD7986 administered alone. Presented as a percentage.|% Geometric Mean Ratio|132.25|||||TWO_SIDED|90.0|121.78|143.64|||ANOVA|||The study was sized for Cmax primarily and not AUC. A two-sided 90% confidence interval for the ratio of AUC between the two treatments groups was used to determine equivalence.||143.64|121.78|
72387797|NCT02653872|144284197|NON_INFERIORITY_OR_EQUIVALENCE|Geometric mean ratio of AUC for AZD7986 administered with itraconazole over AUC for AZD7986 administered alone. Presented as a percentage.|% Geometric Mean Ratio|113.7|||||TWO_SIDED|90.0|104.69|123.49|||ANOVA|||The study was sized for Cmax primarily and not AUC. A two-sided 90% confidence interval for the ratio of AUC between the two treatments groups was used to determine equivalence.||123.49|104.69|
72387798|NCT02653872|144284198|NON_INFERIORITY_OR_EQUIVALENCE|Geometric mean ratio of AUC (0-t) for AZD7986 administered with verapamil over AUC (0-t) for AZD7986 administered alone. Presented as a percentage.|% Geometric Mean Ratio|133.51|||||TWO_SIDED|90.0|122.7|145.29|||ANOVA|||The study was sized for Cmax primarily and not AUC (0-t). A two-sided 90% confidence interval for the ratio of AUC (0-t) between the two treatments groups was used to determine equivalence.||145.29|122.70|
72387799|NCT02653872|144284198|NON_INFERIORITY_OR_EQUIVALENCE|Geometric mean ratio of AUC (0-t) for AZD7986 administered with itraconazole over AUC (0-t) for AZD7986 administered alone. Presented as a percentage.|% Geometric Mean Ratio|112.45|||||TWO_SIDED|90.0|103.34|122.37|||ANOVA|||The study was sized for Cmax primarily and not AUC (0-t). A two-sided 90% confidence interval for the ratio of AUC (0-t) between the two treatments groups was used to determine equivalence.||122.37|103.34|
72387800|NCT00788073|144284218|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2||||0.05|||||||ANCOVA|||||||0.05
72387801|NCT00788073|144284219|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.0||||0.008||95.0|||||ANCOVA|||||||0.008
72441941|NCT02554786|144397208|SUPERIORITY||LS Mean|0.187|STANDARD_ERROR_OF_MEAN|0.0205|<|0.001|TWO_SIDED|95.0|0.147|0.227|||MMRM|||Day 86: 1 hour||0.227|0.147|<0.001
72441942|NCT02554786|144397208|SUPERIORITY||LS Mean|0.249|STANDARD_ERROR_OF_MEAN|0.0208|<|0.001|TWO_SIDED|95.0|0.208|0.289|||MMRM|||Day 86: 1 hour||0.289|0.208|<0.001
72441943|NCT02554786|144397208|SUPERIORITY||LS Mean|0.043|STANDARD_ERROR_OF_MEAN|0.0205||0.037|TWO_SIDED|95.0|0.003|0.083|||MMRM|||Day 86: 1hour||0.083|0.003|0.037
72441944|NCT02554786|144397208|SUPERIORITY||LS Mean|0.163|STANDARD_ERROR_OF_MEAN|0.0217|<|0.001|TWO_SIDED|95.0|0.121|0.206|||MMRM|||Day 183: 5 minutes||0.206|0.121|<0.001
72496273|NCT04426695|144522423|SUPERIORITY|||||||0.05||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.0500
72559352|NCT00577655|144648285|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.138||||0.1699|TWO_SIDED|95.0|-0.335|0.059||significance level of 0.05.|ANCOVA|terms for treatment, center, week, week by treatment, baseline as covariate, subject as random|Active - Placebo|Week 3||0.059|-0.335|0.1699
72496274|NCT04426695|144522423|SUPERIORITY|||||||0.0663||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.0663
72559353|NCT00577655|144648287|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|9.926||||0.1391|TWO_SIDED|95.0|-3.256|23.108||significance level of 0.05.|ANCOVA|terms for treatment, center, week, week by treatment, baseline as a covariate, subject as random.|Active - Placebo|Week 1||23.108|-3.256|0.1391
72559354|NCT00577655|144648287|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|10.923||||0.1043|TWO_SIDED|95.0|-2.278|24.124||significance level of 0.05.|ANCOVA|terms for treatment, center, week, week by treatment, baseline as a covariate, subject as random.|Active - Placebo|Week 2||24.124|-2.278|0.1043
72387802|NCT01589978|144284220|NON_INFERIORITY_OR_EQUIVALENCE|Given the performance goal of 3.2%, with expected rate for PROMUS Element Plus of 2.2% and a one-sided 5% significance level, approximately 1,706 PLATINUM-like patients will provide at least 80% power to reject the null hypothesis if it is false.|||||<|0.0001|||||||Chi-squared|||One-sided, single binomial test will be performed to compare observed rate against performance goal, the normal approximation of the test statistic will be used. The performance goal is met if the one-sided upper 95% confidence bound for the observed binary rate is less than performance goal.||||<.0001
72387803|NCT01589978|144284240|NON_INFERIORITY_OR_EQUIVALENCE|The sample size is calculated for one-sample chi-square test for a single proportion using nQuery AdvisorVersion 5.0. The expected annual increase in ST rate is estimated to be 0.4% based on the current data available from the pooled TAXUS Express and pooled TAXUS Liberté data and the PG is 1.0% using a delta of 0.6%. Given a one-sided 5% significance level, a minimum of 1,660 PLATINUM-like patients at 5-yrs will be required to provide 90% power to reject the null hypothesis if it is false.|||||<|0.0001|||||||Chi-squared|||The expected annual increase of stent thrombosis rate is assumed to be 0.4%, based on the observed increase in incidence rate of stent thrombosis of approximately 0.4% annually for PLATINUM-like patients in the pooled TAXUS SR Express and pooled TAXUS Liberté data. Using a delta of 0.6%, the performance goal is set to 1.0% (expected rate + delta = 0.4% + 0.6% = 1.0%).||||<.0001
72387804|NCT02925117|144284263|SUPERIORITY||Least Squares (LS) Mean Difference|-51.4|STANDARD_ERROR_OF_MEAN|7.65|<|0.001|TWO_SIDED|95.0|-66.5|-36.3|||ANCOVA|Analysis of covariance (ANCOVA) with stratum (geographic region), baseline value, and treatment in the model.||||-36.3|-66.5|< 0.001
72387805|NCT02925117|144284263|SUPERIORITY||LS Mean Difference|-38.7|STANDARD_ERROR_OF_MEAN|7.61|<|0.001|TWO_SIDED|95.0|-53.7|-23.6|||ANCOVA|Analysis of covariance (ANCOVA) with stratum (geographic region), baseline value, and treatment in the model.||||-23.6|-53.7|<0.001
72387806|NCT02925117|144284263|SUPERIORITY||LS Mean Difference|-16.4|STANDARD_ERROR_OF_MEAN|7.61||0.032|TWO_SIDED|95.0|-31.4|-1.4|||ANCOVA|Analysis of covariance (ANCOVA) with stratum (geographic region), baseline value, and treatment in the model.||||-1.4|-31.4|0.032
72387807|NCT02925117|144284264|SUPERIORITY||Adjusted Difference|58.7|||<|0.001|TWO_SIDED|95.0|42.5|74.8|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test, adjusted for stratum (geographic region).||||74.8|42.5|< 0.001
72387808|NCT02925117|144284264|SUPERIORITY||Adjusted Difference|42.5|||<|0.001|TWO_SIDED|95.0|25.5|59.6|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test, adjusted for stratum (geographic region).||||59.6|25.5|<0.001
72387809|NCT02925117|144284264|SUPERIORITY||Adjusted Difference|18.7||||0.022|TWO_SIDED|95.0|2.7|34.7|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test, adjusted for stratum (geographic region).||||34.7|2.7|0.022
72387810|NCT02925117|144284265|SUPERIORITY||Adjusted Difference|46.9|||<|0.001|TWO_SIDED|95.0|31.1|62.7|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test, adjusted for stratum (geographic region).||||62.7|31.1|<0.001
72387811|NCT02925117|144284265|SUPERIORITY||Adjusted Difference|28.6|||<|0.001|TWO_SIDED|95.0|13.8|43.4|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test, adjusted for stratum (geographic region).||||43.4|13.8|<0.001
72387812|NCT02925117|144284265|SUPERIORITY||Adjusted Difference|11.9||||0.044|TWO_SIDED|95.0|0.3|23.5|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test, adjusted for stratum (geographic region).||||23.5|0.3|0.044
72387813|NCT02925117|144284266|SUPERIORITY||LS Mean Difference|-59.3|STANDARD_ERROR_OF_MEAN|6.58|<|0.001|TWO_SIDED|95.0|-72.3|-46.3|||ANCOVA|ANCOVA with stratum (geographic region), baseline value, and treatment in the model.||Analysis of Percent Change from Baseline in Pruritus NRS at Week 2||-46.3|-72.3|<0.001
72387814|NCT02925117|144284266|SUPERIORITY||LS Mean Difference|-47.7|STANDARD_ERROR_OF_MEAN|6.78|<|0.001|TWO_SIDED|95.0|-61.1|-34.3|||ANCOVA|ANCOVA with stratum (geographic region), baseline value, and treatment in the model.||Analysis of Percent Change from Baseline in Pruritus NRS at Week 2||-34.3|-61.1|<0.001
72387815|NCT02925117|144284266|SUPERIORITY||LS Mean Difference|-31.1|STANDARD_ERROR_OF_MEAN|6.7|<|0.001|TWO_SIDED|95.0|-44.3|-17.8|||ANCOVA|ANCOVA with stratum (geographic region), baseline value, and treatment in the model.||Analysis of Percent Change from Baseline in Pruritus NRS at Week 2||-17.8|-44.3|<0.001
72387816|NCT02925117|144284266|SUPERIORITY||LS Mean Difference|-66.4|STANDARD_ERROR_OF_MEAN|8.85|<|0.001|TWO_SIDED|95.0|-83.9|-48.9|||ANCOVA|ANCOVA with stratum (geographic region), baseline value, and treatment in the model.||Analysis of Percent Change from Baseline in Pruritus NRS at Week 8||-48.9|-83.9|<0.001
72387817|NCT02925117|144284266|SUPERIORITY||LS Mean Difference|-38.4|STANDARD_ERROR_OF_MEAN|9.13|<|0.001|TWO_SIDED|95.0|-56.4|-20.4|||ANCOVA|ANCOVA with stratum (geographic region), baseline value, and treatment in the model.||Analysis of Percent Change from Baseline in Pruritus NRS at Week 8||-20.4|-56.4|<0.001
72496275|NCT04426695|144522423|SUPERIORITY|||||||0.0229||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.0229
72441945|NCT02554786|144397208|SUPERIORITY||LS Mean|0.243|STANDARD_ERROR_OF_MEAN|0.0219|<|0.001|TWO_SIDED|95.0|0.2|0.286|||MMRM|||Day 183: 5 minutes||0.286|0.200|<0.001
72441946|NCT02554786|144397208|SUPERIORITY||LS Mean|0.044|STANDARD_ERROR_OF_MEAN|0.0216||0.041|TWO_SIDED|95.0|0.002|0.087|||MMRM|||Day 183: 5 minutes||0.087|0.002|0.041
72441947|NCT02554786|144397208|SUPERIORITY||LS Mean|0.176|STANDARD_ERROR_OF_MEAN|0.0222|<|0.001|TWO_SIDED|95.0|0.133|0.22|||MMRM|||Day 183: 30 minutes||0.220|0.133|<0.001
72441948|NCT02554786|144397208|SUPERIORITY||LS Mean|0.259|STANDARD_ERROR_OF_MEAN|0.0224|<|0.001|TWO_SIDED|95.0|0.215|0.303|||MMRM|||Day 183: 30 minutes||0.303|0.215|<0.001
72441949|NCT02554786|144397208|SUPERIORITY||LS Mean|0.04|STANDARD_ERROR_OF_MEAN|0.0221||0.071|TWO_SIDED|95.0|-0.003|0.083|||MMRM|||Day 183: 30 minutes||0.083|-0.003|0.071
72441950|NCT02554786|144397208|SUPERIORITY||LS Mean|0.18|STANDARD_ERROR_OF_MEAN|0.0219|<|0.001|TWO_SIDED|95.0|0.137|0.223|||MMRM|||Day 183: 1 hour||0.223|0.137|<0.001
72441951|NCT02554786|144397208|SUPERIORITY||LS Mean|0.259|STANDARD_ERROR_OF_MEAN|0.0222|<|0.001|TWO_SIDED|95.0|0.215|0.302|||MMRM|||Day 183: 1 hour||0.302|0.215|<0.001
72441952|NCT02554786|144397208|SUPERIORITY||LS Mean|0.039|STANDARD_ERROR_OF_MEAN|0.0218||0.071|TWO_SIDED|95.0|-0.003|0.082|||MMRM|||Day 183: 1 hour||0.082|-0.003|0.071
72441953|NCT02554786|144397208|SUPERIORITY||LS Mean|0.139|STANDARD_ERROR_OF_MEAN|0.0229|<|0.001|TWO_SIDED|95.0|0.094|0.184|||MMRM|||Day 364: 5 minutes||0.184|0.094|<0.001
72496276|NCT04426695|144522423|SUPERIORITY|||||||0.0208||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.0208
72559355|NCT00577655|144648287|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|9.546||||0.157|TWO_SIDED|95.0|-3.705|22.798||significance level of 0.05.|ANCOVA|terms for treatment, center, week, week by treatment, baseline as a covariate, subject as random.|Active - Placebo|Week 3||22.798|-3.705|0.1570
72441954|NCT02554786|144397208|SUPERIORITY||LS Mean|0.249|STANDARD_ERROR_OF_MEAN|0.0228|<|0.001|TWO_SIDED|95.0|0.205|0.294|||MMRM|||Day 364: 5 minutes||0.294|0.205|<0.001
72441955|NCT02554786|144397208|SUPERIORITY||LS Mean|0.026|STANDARD_ERROR_OF_MEAN|0.0227||0.244|TWO_SIDED|95.0|-0.018|0.071|||MMRM|||Day 364: 5 minutes||0.071|-0.018|0.244
72441956|NCT02554786|144397208|SUPERIORITY||LS Mean|0.155|STANDARD_ERROR_OF_MEAN|0.0228|<|0.001|TWO_SIDED|95.0|0.11|0.2|||MMRM|||Day 364: 30 minutes||0.200|0.110|<0.001
72441957|NCT02554786|144397208|SUPERIORITY||LS Mean|0.264|STANDARD_ERROR_OF_MEAN|0.0227|<|0.001|TWO_SIDED|95.0|0.219|0.308|||MMRM|||Day 364: 30 minutes||0.308|0.219|<0.001
72441958|NCT02554786|144397208|SUPERIORITY||LS Mean|0.032|STANDARD_ERROR_OF_MEAN|0.0226||0.162|TWO_SIDED|95.0|-0.013|0.076|||MMRM|||Day 364: 30 minutes||0.076|-0.013|0.162
72441959|NCT02554786|144397208|SUPERIORITY||LS Mean|0.163|STANDARD_ERROR_OF_MEAN|0.0234|<|0.001|TWO_SIDED|95.0|0.117|0.209|||MMRM|||Day 364: 1 hour||0.209|0.117|<0.001
72441960|NCT02554786|144397208|SUPERIORITY||LS Mean|0.262|STANDARD_ERROR_OF_MEAN|0.0232|<|0.001|TWO_SIDED|95.0|0.216|0.308|||MMRM|||Day 364: 1 hour||0.308|0.216|<0.001
72441961|NCT02554786|144397208|SUPERIORITY||LS Mean|0.031|STANDARD_ERROR_OF_MEAN|0.0231||0.182|TWO_SIDED|95.0|-0.014|0.076|||MMRM|||Day 364: 1 hour||0.076|-0.014|0.182
72441962|NCT02554786|144397209|SUPERIORITY||LS Mean|0.086|STANDARD_ERROR_OF_MEAN|0.0237|<|0.001|TWO_SIDED|95.0|0.04|0.133|||MMRM|||Day 2||0.133|0.040|<0.001
72441963|NCT02554786|144397209|SUPERIORITY||LS Mean|0.139|STANDARD_ERROR_OF_MEAN|0.0235|<|0.001|TWO_SIDED|95.0|0.093|0.185|||MMRM|||Day 2||0.185|0.093|<0.001
72441964|NCT02554786|144397209|SUPERIORITY||LS Mean|-0.002|STANDARD_ERROR_OF_MEAN|0.0237||0.927|TWO_SIDED|95.0|-0.049|0.044|||MMRM|||Day 2||0.044|-0.049|0.927
72441965|NCT02554786|144397209|SUPERIORITY||LS Mean|0.05|STANDARD_ERROR_OF_MEAN|0.0246||0.044|TWO_SIDED|95.0|0.001|0.098|||MMRM|||Day 184||0.098|0.001|0.044
72441966|NCT02554786|144397209|SUPERIORITY||LS Mean|0.141|STANDARD_ERROR_OF_MEAN|0.0246|<|0.001|TWO_SIDED|95.0|0.093|0.19|||MMRM|||Day 184||0.190|0.093|<0.001
72441967|NCT02554786|144397209|SUPERIORITY||LS Mean|0.017|STANDARD_ERROR_OF_MEAN|0.0244||0.49|TWO_SIDED|95.0|-0.031|0.065|||MMRM|||Day 184||0.065|-0.031|0.490
72441968|NCT02554786|144397209|SUPERIORITY||LS Mean|0.076|STANDARD_ERROR_OF_MEAN|0.0249||0.002|TWO_SIDED|95.0|0.027|0.125|||MMRM|||Day 365||0.125|0.027|0.002
72441969|NCT02554786|144397209|SUPERIORITY||LS Mean|0.146|STANDARD_ERROR_OF_MEAN|0.0248|<|0.001|TWO_SIDED|95.0|0.098|0.195|||MMRM|||Day 365||0.195|0.098|<0.001
72441970|NCT02554786|144397209|SUPERIORITY||LS Mean|0.036|STANDARD_ERROR_OF_MEAN|0.0248||0.143|TWO_SIDED|95.0|-0.012|0.085|||MMRM|||Day 365||0.085|-0.012|0.143
72441971|NCT02554786|144397210|SUPERIORITY||LS Mean|0.189|STANDARD_ERROR_OF_MEAN|0.0253|<|0.001|TWO_SIDED|95.0|0.139|0.238|||MMRM|||Day 2||0.238|0.139|<0.001
72441972|NCT02554786|144397210|SUPERIORITY||LS Mean|0.21|STANDARD_ERROR_OF_MEAN|0.025|<|0.001|TWO_SIDED|95.0|0.161|0.259|||MMRM|||Day 2||0.259|0.161|<0.001
72441973|NCT02554786|144397210|SUPERIORITY||LS Mean|-0.018|STANDARD_ERROR_OF_MEAN|0.0252||0.475|TWO_SIDED|95.0|-0.067|0.031|||MMRM|||Day 2||0.031|-0.067|0.475
72441974|NCT02554786|144397210|SUPERIORITY||LS Mean|0.228|STANDARD_ERROR_OF_MEAN|0.0345|<|0.001|TWO_SIDED|95.0|0.161|0.296|||MMRM|||Day 184||0.296|0.161|<0.001
72441975|NCT02554786|144397210|SUPERIORITY||LS Mean|0.265|STANDARD_ERROR_OF_MEAN|0.0346|<|0.001|TWO_SIDED|95.0|0.197|0.333|||MMRM|||Day 184||0.333|0.197|<0.001
72441976|NCT02554786|144397210|SUPERIORITY||LS Mean|0.083|STANDARD_ERROR_OF_MEAN|0.0343||0.015|TWO_SIDED|95.0|0.016|0.151|||MMRM|||Day 184||0.151|0.016|0.015
72441977|NCT02554786|144397210|SUPERIORITY||LS Mean|0.215|STANDARD_ERROR_OF_MEAN|0.0358|<|0.001|TWO_SIDED|95.0|0.145|0.285|||MMRM|||Day 365||0.285|0.145|<0.001
72441978|NCT02554786|144397210|SUPERIORITY||LS Mean|0.246|STANDARD_ERROR_OF_MEAN|0.0357|<|0.001|TWO_SIDED|95.0|0.176|0.316|||MMRM|||Day 365||0.316|0.176|<0.001
72441979|NCT02554786|144397210|SUPERIORITY||LS Mean|0.053|STANDARD_ERROR_OF_MEAN|0.0356||0.139|TWO_SIDED|95.0|-0.017|0.122|||MMRM|||Day 365||0.122|-0.017|0.139
72441980|NCT02554786|144397211|SUPERIORITY||LS Mean|29.6|STANDARD_ERROR_OF_MEAN|2.96|<|0.001|TWO_SIDED|95.0|23.8|35.4|||Linear Mixed Model (LMM)|||Week 26: Mean morning PEF||35.4|23.8|<0.001
72441981|NCT02554786|144397211|SUPERIORITY||LS Mean|32.2|STANDARD_ERROR_OF_MEAN|2.97|<|0.001|TWO_SIDED|95.0|26.4|38.1|||LMM|||Week 26: Mean morning PEF||38.1|26.4|<0.001
72441982|NCT02554786|144397211|SUPERIORITY||LS Mean|13.3|STANDARD_ERROR_OF_MEAN|2.97|<|0.001|TWO_SIDED|95.0|7.5|19.1|||LMM|||Week 26: Mean morning PEF||19.1|7.5|<0.001
72441983|NCT02554786|144397211|SUPERIORITY||LS Mean|24.8|STANDARD_ERROR_OF_MEAN|2.82|<|0.001|TWO_SIDED|95.0|19.3|30.3|||LMM|||Week 26: Mean evening PEF||30.3|19.3|<0.001
72441984|NCT02554786|144397211|SUPERIORITY||LS Mean|30.4|STANDARD_ERROR_OF_MEAN|2.83|<|0.001|TWO_SIDED|95.0|24.8|35.9|||LMM|||Week 26: Mean evening PEF||35.9|24.8|<0.001
72441985|NCT02554786|144397211|SUPERIORITY||LS Mean|8.6|STANDARD_ERROR_OF_MEAN|2.83||0.002|TWO_SIDED|95.0|3.1|14.2|||LMM|||Week 26: Mean evening PEF||14.2|3.1|0.002
72441986|NCT02554786|144397211|SUPERIORITY||LS Mean|28.7|STANDARD_ERROR_OF_MEAN|3.07|<|0.001|TWO_SIDED|95.0|22.7|34.8|||LMM|||Week 52: Mean morning PEF||34.8|22.7|<0.001
72441987|NCT02554786|144397211|SUPERIORITY||LS Mean|30.2|STANDARD_ERROR_OF_MEAN|3.07|<|0.001|TWO_SIDED|95.0|24.2|36.3|||LMM|||Week 52: Mean morning PEF||36.3|24.2|<0.001
72441988|NCT02554786|144397211|SUPERIORITY||LS Mean|13.8|STANDARD_ERROR_OF_MEAN|3.08|<|0.001|TWO_SIDED|95.0|7.7|19.8|||LMM|||Week 52: Mean morning PEF||19.8|7.7|<0.001
72441989|NCT02554786|144397211|SUPERIORITY||LS Mean|23.7|STANDARD_ERROR_OF_MEAN|2.94|<|0.001|TWO_SIDED|95.0|18.0|29.5|||LMM|||Week 52: Mean evening PEF||29.5|18.0|<0.001
72441990|NCT02554786|144397211|SUPERIORITY||LS Mean|29.1|STANDARD_ERROR_OF_MEAN|2.94|<|0.001|TWO_SIDED|95.0|23.3|34.8|||LMM|||Week 52: Mean evening PEF||34.8|23.3|<0.001
72441991|NCT02554786|144397211|SUPERIORITY||LS Mean|9.1|STANDARD_ERROR_OF_MEAN|2.95||0.002|TWO_SIDED|95.0|3.3|14.9|||LMM|||Week 52: Mean evening PEF||14.9|3.3|0.002
72622357|NCT00835042|144774577|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|91.0||||||90.0|81.8|101.0|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||101|81.8|
72441992|NCT02554786|144397212|SUPERIORITY||Odds Ratio (OR)|1.31||||0.094|TWO_SIDED|95.0|0.95|1.81|||Logistic regression model|||Day 183||1.81|0.95|0.094
72441993|NCT02554786|144397212|SUPERIORITY||Odds Ratio (OR)|1.73|||<|0.001|TWO_SIDED|95.0|1.26|2.37|||Logistic regression model|||Day 183||2.37|1.26|<0.001
72441994|NCT02554786|144397212|SUPERIORITY||Odds Ratio (OR)|1.06||||0.746|TWO_SIDED|95.0|0.76|1.46|||Logistic regression model|||Day 183||1.46|0.76|0.746
72441995|NCT02554786|144397212|SUPERIORITY||Odds Ratio (OR)|1.34||||0.088|TWO_SIDED|95.0|0.96|1.87|||Logistic regression model|||Day 364||1.87|0.96|0.088
72441996|NCT02554786|144397212|SUPERIORITY||Odds Ratio (OR)|2.24|||<|0.001|TWO_SIDED|95.0|1.58|3.17|||Logistic regression model|||Day 364||3.17|1.58|<0.001
72441997|NCT02554786|144397212|SUPERIORITY||Odds Ratio (OR)|1.05||||0.771|TWO_SIDED|95.0|0.75|1.49|||Logistic regression model|||Day 364||1.49|0.75|0.771
72441998|NCT02554786|144397213|SUPERIORITY||LS Mean|5.8|STANDARD_ERROR_OF_MEAN|2.29||0.012|TWO_SIDED|95.0|1.3|10.2|||Linear Mixed Model (LMM)|||||10.2|1.3|0.012
72441999|NCT02554786|144397213|SUPERIORITY||LS Mean|9.1|STANDARD_ERROR_OF_MEAN|2.29|<|0.001|TWO_SIDED|95.0|4.6|13.6|||LMM|||||13.6|4.6|<0.001
72442000|NCT02554786|144397213|SUPERIORITY||LS Mean|3.4|STANDARD_ERROR_OF_MEAN|2.29||0.135|TWO_SIDED|95.0|-1.1|7.9|||LMM|||||7.9|-1.1|0.135
72442001|NCT02554786|144397214|SUPERIORITY||LS Mean|5.0|STANDARD_ERROR_OF_MEAN|2.25||0.026|TWO_SIDED|95.0|0.6|9.4|||LMM|||||9.4|0.6|0.026
72442002|NCT02554786|144397214|SUPERIORITY||LS Mean|8.1|STANDARD_ERROR_OF_MEAN|2.25|<|0.001|TWO_SIDED|95.0|3.7|12.5|||LMM|||||12.5|3.7|<0.001
72442003|NCT02554786|144397214|SUPERIORITY||LS Mean|3.2|STANDARD_ERROR_OF_MEAN|2.25||0.151|TWO_SIDED|95.0|-1.2|7.7|||LMM|||||7.7|-1.2|0.151
72442004|NCT02554786|144397215|SUPERIORITY||LS Mean|2.8|STANDARD_ERROR_OF_MEAN|1.72||0.104|TWO_SIDED|95.0|-0.6|6.2|||LMM|||||6.2|-0.6|0.104
72442005|NCT02554786|144397215|SUPERIORITY||LS Mean|3.9|STANDARD_ERROR_OF_MEAN|1.72||0.024|TWO_SIDED|95.0|0.5|7.3|||LMM|||||7.3|0.5|0.024
72442006|NCT02554786|144397215|SUPERIORITY||LS Mean|0.9|STANDARD_ERROR_OF_MEAN|1.73||0.588|TWO_SIDED|95.0|-2.5|4.3|||LMM|||||4.3|-2.5|0.588
72442007|NCT02554786|144397216|SUPERIORITY||LS Mean|6.4|STANDARD_ERROR_OF_MEAN|2.19||0.003|TWO_SIDED|95.0|2.1|10.7|||LMM|||||10.7|2.1|0.003
72442008|NCT02554786|144397216|SUPERIORITY||LS Mean|8.9|STANDARD_ERROR_OF_MEAN|2.19|<|0.001|TWO_SIDED|95.0|4.6|13.2|||LMM|||||13.2|4.6|<0.001
72442009|NCT02554786|144397216|SUPERIORITY||LS Mean|4.8|STANDARD_ERROR_OF_MEAN|2.2||0.029|TWO_SIDED|95.0|0.5|9.1|||LMM|||||9.1|0.5|0.029
72442010|NCT02554786|144397217|SUPERIORITY||LS Mean|-0.13|STANDARD_ERROR_OF_MEAN|0.039||0.001|TWO_SIDED|95.0|-0.2|-0.05|||LMM|||Week1-26 Mean night-time number of puffs||-0.05|-0.2|0.001
72442011|NCT02554786|144397217|SUPERIORITY||LS Mean|-0.08|STANDARD_ERROR_OF_MEAN|0.039||0.035|TWO_SIDED|95.0|-0.16|-0.01|||LMM|||Week 1-26 Mean night-time number of puffs||-0.01|-0.16|0.035
72442012|NCT02554786|144397217|SUPERIORITY||LS Mean|-0.04|STANDARD_ERROR_OF_MEAN|0.039||0.261|TWO_SIDED|95.0|-0.12|0.03|||LMM|||Week 1-26 Mean night-time number of puffs||0.03|-0.12|0.261
72442013|NCT02554786|144397217|SUPERIORITY||LS Mean|-0.19|STANDARD_ERROR_OF_MEAN|0.047|<|0.001|TWO_SIDED|95.0|-0.28|-0.09|||LMM|||Week 1-26 Mean daytime number of puffs||-0.09|-0.28|<0.001
72442014|NCT02554786|144397217|SUPERIORITY||LS Mean|-0.12|STANDARD_ERROR_OF_MEAN|0.047||0.011|TWO_SIDED|95.0|-0.21|-0.03|||LMM|||Week 1-26 Mean daytime number of puffs||-0.03|-0.21|0.011
72442015|NCT02554786|144397217|SUPERIORITY||LS Mean|-0.04|STANDARD_DEVIATION|0.047||0.425|TWO_SIDED|95.0|-0.13|0.06|||LMM|||Week 1-26 Mean daytime number of puffs||0.06|-0.13|0.425
72442016|NCT02554786|144397217|SUPERIORITY||LS Mean|-0.31|STANDARD_ERROR_OF_MEAN|0.081|<|0.001|TWO_SIDED|95.0|-0.46|-0.15|||LMM|||Week 1-26 Mean daily number of puffs||-0.15|-0.46|<0.001
72442017|NCT02554786|144397217|SUPERIORITY||LS Mean|-0.19|STANDARD_ERROR_OF_MEAN|0.081||0.017|TWO_SIDED|95.0|-0.35|-0.03|||LMM|||Week 1-26 Mean daily number of puffs||-0.03|-0.35|0.017
72442018|NCT02554786|144397217|SUPERIORITY||LS Mean|-0.09|STANDARD_ERROR_OF_MEAN|0.081||0.29|TWO_SIDED|95.0|-0.24|-0.07|||LMM|||Week 1-26 Mean daily number of puffs||-0.07|-0.24|0.29
72442019|NCT02554786|144397217|SUPERIORITY||LS Mean|-0.11|STANDARD_ERROR_OF_MEAN|0.039||0.004|TWO_SIDED|95.0|-0.19|-0.04|||LMM|||Week 1-52 Mean night-time number of puffs||-0.04|-0.19|0.004
72442020|NCT02554786|144397217|SUPERIORITY||LS Mean|-0.09|STANDARD_ERROR_OF_MEAN|0.039||0.019|TWO_SIDED|95.0|-0.17|-0.02|||LMM|||Week 1-52 Mean night-time number of puffs||-0.02|-0.17|0.019
72442021|NCT02554786|144397217|SUPERIORITY||LS Mean|-0.05|STANDARD_ERROR_OF_MEAN|0.039||0.226|TWO_SIDED|95.0|-0.12|0.03|||LMM|||Week 1-52 Mean night-time number of puffs||0.03|-0.12|0.226
72559356|NCT00577655|144648288|SUPERIORITY_OR_OTHER_LEGACY||ratio of Active to Placebo|0.989||||0.9846|TWO_SIDED|95.0|-0.121|2.099||significance level of 0.05.|mixed poisson regression model|||"Week 1~P-value, mean and confidence interval calculated from a 0 inflated mixed poisson regression model with fixed effect terms for treatment, week, treatment by week interaction, baseline as a covariate and a random term for subject. The null hypothesis is that the ratio equals 1. Estimated means are conditional upon the random effect, assume a random effect of 0 and a covariate value at the average."||2.099|-0.121|0.9846
72387818|NCT02925117|144284266|SUPERIORITY||LS Mean Difference|-28.9|STANDARD_ERROR_OF_MEAN|8.96||0.002|TWO_SIDED|95.0|-46.6|-11.2|||ANCOVA|ANCOVA with stratum (geographic region), baseline value, and treatment in the model.||Analysis of Percent Change from Baseline in Pruritus NRS at Week 8||-11.2|-46.6|0.002
72387819|NCT02925117|144284266|SUPERIORITY||LS Mean Difference|-59.2|STANDARD_ERROR_OF_MEAN|9.78|<|0.001|TWO_SIDED|95.0|-78.6|-39.9|||ANCOVA|ANCOVA with stratum (geographic region), baseline value, and treatment in the model.||Analysis of Percent Change from Baseline in Pruritus NRS at Week 16||-39.9|-78.6|<0.001
72387820|NCT02925117|144284266|SUPERIORITY||LS Mean Difference|-38.3|STANDARD_ERROR_OF_MEAN|10.08|<|0.001|TWO_SIDED|95.0|-58.3|-18.4|||ANCOVA|ANCOVA with stratum (geographic region), baseline value, and treatment in the model.||Analysis of Percent Change from Baseline in Pruritus NRS at Week 16||-18.4|-58.3|<0.001
72387821|NCT02925117|144284266|SUPERIORITY||LS Mean Difference|-29.9|STANDARD_ERROR_OF_MEAN|9.9||0.003|TWO_SIDED|95.0|-49.4|-10.3|||ANCOVA|ANCOVA with stratum (geographic region), baseline value, and treatment in the model.||Analysis of Percent Change from Baseline in Pruritus NRS at Week 16||-10.3|-49.4|0.003
72387822|NCT02925117|144284267|SUPERIORITY||LS Mean Difference|-65.3|STANDARD_ERROR_OF_MEAN|7.46|<|0.001|TWO_SIDED|95.0|-80.0|-50.5|||ANCOVA|ANCOVA with stratum (geographic region), baseline value, and treatment in the model.||||-50.5|-80.0|<0.001
72387823|NCT02925117|144284267|SUPERIORITY||LS Mean Difference|-47.9|STANDARD_ERROR_OF_MEAN|7.42|<|0.001|TWO_SIDED|95.0|-62.6|-33.3|||ANCOVA|ANCOVA with stratum (geographic region), baseline value, and treatment in the model.||||-33.3|-62.6|<0.001
72387824|NCT02925117|144284267|SUPERIORITY||LS Mean Difference|-26.2|STANDARD_ERROR_OF_MEAN|7.42|<|0.001|TWO_SIDED|95.0|-40.8|-11.5|||ANCOVA|ANCOVA with stratum (geographic region), baseline value, and treatment in the model.||||-11.5|-40.8|<0.001
72387825|NCT02925117|144284268|SUPERIORITY||LS Mean Difference|-58.3|STANDARD_ERROR_OF_MEAN|6.78|<|0.001|TWO_SIDED|95.0|-71.7|-44.9|||ANCOVA|ANCOVA with stratum (geographic region), baseline value, and treatment in the model.||Analysis of Percent Change from Baseline in SCORAD at Week 8||-44.9|-71.7|<0.001
72387826|NCT02925117|144284268|SUPERIORITY||LS Mean Difference|-37.1|STANDARD_ERROR_OF_MEAN|6.94|<|0.001|TWO_SIDED|95.0|-50.8|-23.4|||ANCOVA|ANCOVA with stratum (geographic region), baseline value, and treatment in the model.||Analysis of Percent Change from Baseline in SCORAD at Week 8||-23.4|-50.8|<0.001
72387827|NCT02925117|144284268|SUPERIORITY||LS Mean Difference|-28.4|STANDARD_ERROR_OF_MEAN|6.81|<|0.001|TWO_SIDED|95.0|-41.9|-15.0|||ANCOVA|ANCOVA with stratum (geographic region), baseline value, and treatment in the model.||Analysis of Percent Change from Baseline in SCORAD at Week 8||-15.0|-41.9|<0.001
72387828|NCT02925117|144284268|SUPERIORITY||LS Mean Difference|-48.0|STANDARD_ERROR_OF_MEAN|6.93|<|0.001|TWO_SIDED|95.0|-61.7|-34.3|||ANCOVA|ANCOVA with stratum (geographic region), baseline value, and treatment in the model.||Analysis of Percent Change from Baseline in SCORAD at Week 16||-34.3|-61.7|<0.001
72387829|NCT02925117|144284268|SUPERIORITY||LS Mean Difference|-34.5|STANDARD_ERROR_OF_MEAN|7.1|<|0.001|TWO_SIDED|95.0|-48.5|-20.5|||ANCOVA|ANCOVA with stratum (geographic region), baseline value, and treatment in the model.||Analysis of Percent Change from Baseline in SCORAD at Week 16||-20.5|-48.5|<0.001
72387830|NCT02925117|144284268|SUPERIORITY||LS Mean Difference|-20.2|STANDARD_ERROR_OF_MEAN|6.96||0.004|TWO_SIDED|95.0|-33.9|-6.4|||ANCOVA|ANCOVA with stratum (geographic region), baseline value, and treatment in the model.||Analysis of Percent Change from Baseline in SCORAD at Week 16||-6.4|-33.9|0.004
72387831|NCT02925117|144284269|SUPERIORITY||Adjusted Difference|72.7|||<|0.001|TWO_SIDED|95.0|58.3|87.1|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (geographic region).||||87.1|58.3|<0.001
72387832|NCT02925117|144284269|SUPERIORITY||Adjusted Difference|44.9|||<|0.001|TWO_SIDED|95.0|27.9|61.9|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (geographic region).||||61.9|27.9|<0.001
72387833|NCT02925117|144284269|SUPERIORITY||Adjusted Difference|23.4||||0.004|TWO_SIDED|95.0|7.5|39.4|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (geographic region).||||39.4|7.5|0.004
72387834|NCT02925117|144284270|SUPERIORITY||Adjusted Difference|70.7|||<|0.001|TWO_SIDED|95.0|56.2|85.2|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (geographic region).||Analysis of EASI 50 Response at Week 8||85.2|56.2|<0.001
72442022|NCT02554786|144397217|SUPERIORITY||LS Mean|-0.17|STANDARD_ERROR_OF_MEAN|0.048|<|0.001|TWO_SIDED|95.0|-0.26|-0.07|||LMM|||Week 1-52 Mean daytime number of puffs||-0.07|-0.26|<0.001
72442023|NCT02554786|144397217|SUPERIORITY||LS Mean|-0.15|STANDARD_ERROR_OF_MEAN|0.048||0.002|TWO_SIDED|95.0|-0.24|-0.05|||LMM|||Week 1-52 Mean daytime number of puffs||-0.05|-0.24|0.002
72442024|NCT02554786|144397217|SUPERIORITY||LS Mean|-0.04|STANDARD_ERROR_OF_MEAN|0.048||0.384|TWO_SIDED|95.0|-0.14|0.05|||LMM|||Week 1-52 Mean daytime number of puffs||0.05|-0.14|0.384
72442025|NCT02554786|144397217|SUPERIORITY||LS Mean|-0.28|STANDARD_ERROR_OF_MEAN|0.081|<|0.001|TWO_SIDED|95.0|-0.44|-0.12|||LMM|||Week 1-52 Mean daily number of puffs||-0.12|-0.44|< 0.001
72442026|NCT02554786|144397217|SUPERIORITY||LS Mean|-0.23|STANDARD_ERROR_OF_MEAN|0.081||0.004|TWO_SIDED|95.0|-0.39|-0.07|||LMM|||Week 1-52 Mean daily number of puffs||-0.07|-0.39|0.004
72442027|NCT02554786|144397217|SUPERIORITY||LS Mean|-0.09|STANDARD_ERROR_OF_MEAN|0.081||0.245|TWO_SIDED|95.0|-0.25|0.06|||LMM|||Week 1-52 Mean daily number of puffs||0.06|-0.25|0.245
72442028|NCT02554786|144397218|SUPERIORITY||Hazard Ratio (HR)|0.53|||<|0.001|TWO_SIDED|95.0|0.39|0.72|||Regression, Cox|||Moderate or severe asthma exacerbation||0.72|0.39|<0.001
72442029|NCT02554786|144397218|SUPERIORITY||Hazard Ratio (HR)|0.45|||<|0.001|TWO_SIDED|95.0|0.34|0.6|||Regression, Cox|||Moderate or severe asthma exacerbation||0.6|0.34|<0.001
72442030|NCT02554786|144397218|SUPERIORITY||Hazard Ratio (HR)|0.81||||0.209|TWO_SIDED|95.0|0.59|1.12|||Regression, Cox|||Moderate or severe asthma exacerbation||1.12|0.59|0.209
72442031|NCT02554786|144397218|SUPERIORITY||Hazard Ratio (HR)|0.54||||0.003|TWO_SIDED|95.0|0.36|0.81|||Regression, Cox|||Severe asthma exacerbation||0.81|0.36|0.003
72442032|NCT02554786|144397218|SUPERIORITY||Hazard Ratio (HR)|0.44|||<|0.001|TWO_SIDED|95.0|0.3|0.63|||Regression, Cox|||Severe asthma exacerbation||0.63|0.3|<0.001
72387835|NCT02925117|144284270|SUPERIORITY||Adjusted Difference|49.0|||<|0.001|TWO_SIDED|95.0|30.8|67.3|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (geographic region).||Analysis of EASI 50 Response at Week 8||67.3|30.8|<0.001
72387836|NCT02925117|144284270|SUPERIORITY||Adjusted Difference|32.8|||<|0.001|TWO_SIDED|95.0|13.4|52.2|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (geographic region).||Analysis of EASI 50 Response at Week 8||52.2|13.4|<0.001
72387837|NCT02925117|144284270|SUPERIORITY||Adjusted Difference|60.6|||<|0.001|TWO_SIDED|95.0|45.3|75.9|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (geographic region).||Analysis of EASI 50 Response at Week 16||75.9|45.3|<0.001
72387838|NCT02925117|144284270|SUPERIORITY||Adjusted Difference|48.6|||<|0.001|TWO_SIDED|95.0|31.3|65.9|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (geographic region).||Analysis of EASI 50 Response at Week 16||65.9|31.3|<0.001
72387839|NCT02925117|144284270|SUPERIORITY||Adjusted Difference|28.2||||0.003|TWO_SIDED|95.0|9.8|46.6|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (geographic region).||Analysis of EASI 50 Response at Week 16||46.6|9.8|0.003
72387840|NCT02925117|144284271|SUPERIORITY||Adjusted Difference|43.8|||<|0.001|TWO_SIDED|95.0|29.1|58.5|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (geographic region).||Analysis of EASI 90 Response at Week 8||58.5|29.1|<0.001
72387841|NCT02925117|144284271|SUPERIORITY||Adjusted Difference|26.1|||<|0.001|TWO_SIDED|95.0|12.6|39.6|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (geographic region).||Analysis of EASI 90 Response at Week 8||39.6|12.6|<0.001
72387842|NCT02925117|144284271|SUPERIORITY||Adjusted Difference|9.4||||0.051|TWO_SIDED|95.0|0.0|18.8|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (geographic region).||Analysis of EASI 90 Response at Week 8||18.8|-0.0|0.051
72387843|NCT02925117|144284271|SUPERIORITY||Adjusted Difference|46.9|||<|0.001|TWO_SIDED|95.0|31.3|62.4|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (geographic region).||Analysis of EASI 90 Response at Week 16||62.4|31.3|<0.001
72387844|NCT02925117|144284271|SUPERIORITY||Adjusted Difference|23.8||||0.001|TWO_SIDED|95.0|9.6|38.1|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (geographic region).||Analysis of EASI 90 Response at Week 16||38.1|9.6|0.001
72387845|NCT02925117|144284271|SUPERIORITY||Adjusted Difference|11.8||||0.049|TWO_SIDED|95.0|0.1|23.6|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (geographic region).||Analysis of EASI 90 Response at Week 16||23.6|0.1|0.049
72387846|NCT02925117|144284272|SUPERIORITY||Adjusted Difference|68.4|||<|0.001|TWO_SIDED|95.0|54.0|82.8|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (geographic region).||Analysis of SCORAD 50 Response at Week 8||82.8|54.0|<0.001
72387847|NCT02925117|144284272|SUPERIORITY||Adjusted Difference|35.3|||<|0.001|TWO_SIDED|95.0|18.5|52.2|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (geographic region).||Analysis of SCORAD 50 Response at Week 8||52.2|18.5|<0.001
72387848|NCT02925117|144284272|SUPERIORITY||Adjusted Difference|25.7||||0.002|TWO_SIDED|95.0|9.6|41.7|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (geographic region).||Analysis of SCORAD 50 Response at Week 8||41.7|9.6|0.002
72387849|NCT02925117|144284272|SUPERIORITY||Adjusted Difference|54.5|||<|0.001|TWO_SIDED|95.0|39.0|69.9|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (geographic region).||Analysis of SCORAD 50 Response at Week 16||69.9|39.0|<0.001
72387850|NCT02925117|144284272|SUPERIORITY||Adjusted Difference|35.8|||<|0.001|TWO_SIDED|95.0|19.1|52.5|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (geographic region).||Analysis of SCORAD 50 Response at Week 16||52.5|19.1|<0.001
72387851|NCT02925117|144284272|SUPERIORITY||Adjusted Difference|21.2||||0.008|TWO_SIDED|95.0|5.7|36.8|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (geographic region).||Analysis of SCORAD 50 Response at Week 16||36.8|5.7|0.008
72387852|NCT02925117|144284273|SUPERIORITY||Adjusted Difference|30.4|||<|0.001|TWO_SIDED|95.0|16.2|44.6|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (geographic region).||Analysis of SCORAD 75 Response at Week 8||44.6|16.2|<0.001
72387853|NCT02925117|144284273|SUPERIORITY||Adjusted Difference|9.4||||0.052|TWO_SIDED|95.0|-0.1|18.9|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (geographic region).||Analysis of SCORAD 75 Response at Week 8||18.9|-0.1|0.052
72387854|NCT02925117|144284273|SUPERIORITY||Adjusted Difference|9.3||||0.048|TWO_SIDED|95.0|0.1|18.5|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (geographic region).||Analysis of SCORAD 75 Response at Week 8||18.5|0.1|0.048
72387855|NCT02925117|144284273|SUPERIORITY||Adjusted Difference|37.7|||<|0.001|TWO_SIDED|95.0|22.2|53.3|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (geographic region).||Analysis of SCORAD 75 Response at Week 16||53.3|22.2|<0.001
72387856|NCT02925117|144284273|SUPERIORITY||Adjusted Difference|19.0||||0.006|TWO_SIDED|95.0|5.6|32.5|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (geographic region).||Analysis of SCORAD 75 Response at Week 16||32.5|5.6|0.006
72387857|NCT02925117|144284273|SUPERIORITY||Adjusted Difference|2.4||||0.581|TWO_SIDED|95.0|-6.0|10.8|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (geographic region).||Analysis of SCORAD 75 Response at Week 16||10.8|-6.0|0.581
72387858|NCT02925117|144284274|SUPERIORITY||Adjusted Difference|14.2||||0.012|TWO_SIDED|95.0|3.2|25.2|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (geographic region).||Analysis of SCORAD 90 Response at Week 8||25.2|3.2|0.012
72387859|NCT02925117|144284274|SUPERIORITY||Adjusted Difference|2.3||||0.428|TWO_SIDED|95.0|-3.4|8.0|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (geographic region).||Analysis of SCORAD 90 Response at Week 8||8.0|-3.4|0.428
72442033|NCT02554786|144397218|SUPERIORITY||Hazard Ratio (HR)|0.71||||0.115|TWO_SIDED|95.0|0.47|1.09|||Regression, Cox|||Severe asthma exacerbation||1.09|0.47|0.115
72442034|NCT02554786|144397218|SUPERIORITY||Hazard Ratio (HR)|0.65|||<|0.001|TWO_SIDED|95.0|0.51|0.82|||Regression, Cox|||All asthma exacerbation||0.82|0.51|<0.001
72559357|NCT00577655|144648288|SUPERIORITY_OR_OTHER_LEGACY||ratio of Active to Placebo|0.961||||0.9447|TWO_SIDED|95.0|-0.116|2.039||significance level of 0.05.|mixed poisson regression model|||"Week 2~P-value, mean and confidence interval calculated from a 0 inflated mixed poisson regression model with fixed effect terms for treatment, week, treatment by week interaction, baseline as a covariate and a random term for subject. The null hypothesis is that the ratio equals 1. Estimated means are conditional upon the random effect, assume a random effect of 0 and a covariate value at the average."||2.039|-0.116|0.9447
72387860|NCT02925117|144284274|SUPERIORITY||Adjusted Difference|4.6||||0.206|TWO_SIDED|95.0|-2.5|11.8|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (geographic region).||Analysis of SCORAD 90 Response at Week 8||11.8|-2.5|0.206
72387861|NCT02925117|144284274|SUPERIORITY||Adjusted Difference|23.3|||<|0.001|TWO_SIDED|95.0|10.4|36.2|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (geographic region).||Analysis of SCORAD 90 Response at Week 16||36.2|10.4|<0.001
72387862|NCT02925117|144284274|SUPERIORITY||Adjusted Difference|9.4||||0.048|TWO_SIDED|95.0|0.1|18.8|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (geographic region).||Analysis of SCORAD 90 Response at Week 16||18.8|0.1|0.048
72387863|NCT02925117|144284274|SUPERIORITY||Adjusted Difference|2.4||||0.426|TWO_SIDED|95.0|-3.4|8.1|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (geographic region).||Analysis of SCORAD 90 Response at Week 16||8.1|-3.4|0.426
72387864|NCT02925117|144284280|SUPERIORITY||LS Mean Difference|-26.5|STANDARD_ERROR_OF_MEAN|4.25|<|0.001|TWO_SIDED|95.0|-34.9|-18.1|||ANCOVA|ANCOVA with stratum (geographic region), baseline value, and treatment in the model.||||-18.1|-34.9|<0.001
72387865|NCT02925117|144284280|SUPERIORITY||LS Mean Difference|-23.0|STANDARD_ERROR_OF_MEAN|4.27|<|0.001|TWO_SIDED|95.0|-31.4|-14.6|||ANCOVA|ANCOVA with stratum (geographic region), baseline value, and treatment in the model.||||-14.6|-31.4|<0.001
72387866|NCT02925117|144284280|SUPERIORITY||LS Mean Difference|-7.6|STANDARD_ERROR_OF_MEAN|4.25||0.075|TWO_SIDED|95.0|-16.0|0.8|||ANCOVA|ANCOVA with stratum (geographic region), baseline value, and treatment in the model.||||0.8|-16.0|0.075
72387867|NCT02925117|144284281|SUPERIORITY||Adjusted Difference|47.4|||<|0.001|TWO_SIDED|95.0|29.6|65.2|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (geographic region).||||65.2|29.6|<0.001
72387868|NCT02925117|144284281|SUPERIORITY||Adjusted Difference|53.4|||<|0.001|TWO_SIDED|95.0|35.5|71.3|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (geographic region).||||71.3|35.5|<0.001
72387869|NCT02925117|144284281|SUPERIORITY||Adjusted Difference|18.6||||0.021|TWO_SIDED|95.0|2.8|34.3|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (geographic region).||||34.3|2.8|0.021
72387870|NCT01681472|144284303|SUPERIORITY|||||||0.0323|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of \[6R\]-5,10-methylene-THF concentration in tumor tissue was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0323
72387871|NCT01681472|144284303|SUPERIORITY|||||||0.1336|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of \[6R\]-5,10-methylene-THF concentration in tumor tissue was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.1336
72387872|NCT01681472|144284303|SUPERIORITY|||||||0.8622|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of \[6R\]-5,10-methylene-THF concentration in tumor tissue was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.8622
72387873|NCT01681472|144284303|SUPERIORITY|||||||0.0024|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of \[6R\]-5,10-methylene-THF concentration in tumor tissue was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0024
72387874|NCT01681472|144284303|SUPERIORITY|||||||0.0074|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of \[6R\]-5,10-methylene-THF concentration in tumor tissue was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0074
72387875|NCT01681472|144284303|SUPERIORITY|||||||0.1752|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of \[6R\]-5,10-methylene-THF concentration in tumor tissue was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.1752
72387876|NCT01681472|144284304|SUPERIORITY|||||||0.148|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of \[6R\]-5,10-methylene-THF concentration in mucosa adjacent to the tumor was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.1480
72387877|NCT01681472|144284304|SUPERIORITY|||||||0.0034|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of \[6R\]-5,10-methylene-THF concentration in mucosa adjacent to the tumor was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0034
72387878|NCT01681472|144284304|SUPERIORITY|||||||0.0177|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of \[6R\]-5,10-methylene-THF concentration in mucosa adjacent to the tumor was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0177
72387879|NCT01681472|144284304|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of \[6R\]-5,10-methylene-THF concentration in mucosa adjacent to the tumor was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||<0.0001
72387880|NCT01681472|144284304|SUPERIORITY|||||||0.0019|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of \[6R\]-5,10-methylene-THF concentration in mucosa adjacent to the tumor was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0019
72496277|NCT04426695|144522423|SUPERIORITY|||||||0.0388||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.0388
72496278|NCT04426695|144522423|SUPERIORITY|||||||0.0092||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.0092
72496279|NCT04426695|144522427|SUPERIORITY|||||||0.037|||||||stratified log-rank test|||||||0.0370
72496280|NCT04426695|144522427|SUPERIORITY|||||||0.1596|||||||stratified log-rank test|||||||0.1596
72496281|NCT04426695|144522427|SUPERIORITY|||||||0.0444|||||||stratified log-rank test|||||||0.0444
72387881|NCT01681472|144284304|SUPERIORITY|||||||0.0118|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of \[6R\]-5,10-methylene-THF concentration in mucosa adjacent to the tumor was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0118
72387882|NCT01681472|144284305|SUPERIORITY|||||||0.1182|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of \[6S\]-5-THF concentration in tumor was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.1182
72387883|NCT01681472|144284305|SUPERIORITY|||||||0.0538|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of \[6S\]-5-THF concentration in tumor was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0538
72387884|NCT01681472|144284305|SUPERIORITY|||||||0.5244|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of \[6S\]-5-THF concentration in tumor was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.5244
72387885|NCT01681472|144284305|SUPERIORITY|||||||0.0081|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of \[6S\]-5-THF concentration in tumor was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0081
72387886|NCT01681472|144284305|SUPERIORITY|||||||0.0313|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of \[6S\]-5-THF concentration in tumor was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0313
72387887|NCT01681472|144284305|SUPERIORITY|||||||0.4777|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of \[6S\]-5-THF concentration in tumor was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.4777
72387888|NCT01681472|144284306|SUPERIORITY|||||||0.2716|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of \[6S\]-5-THF concentration in mucosa adjacent to the tumor was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.2716
72387889|NCT01681472|144284306|SUPERIORITY|||||||0.0124|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of \[6S\]-5-THF concentration in mucosa adjacent to the tumor was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0124
72387890|NCT01681472|144284306|SUPERIORITY|||||||0.0728|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of \[6S\]-5-THF concentration in mucosa adjacent to the tumor was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0728
72387891|NCT01681472|144284306|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of \[6S\]-5-THF concentration in mucosa adjacent to the tumor was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||<0.0001
72387892|NCT01681472|144284306|SUPERIORITY|||||||0.0039|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of \[6S\]-5-THF concentration in mucosa adjacent to the tumor was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0039
72387893|NCT01681472|144284306|SUPERIORITY|||||||0.0454|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of \[6S\]-5-THF concentration in mucosa adjacent to the tumor was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0454
72387894|NCT01681472|144284307|SUPERIORITY|||||||0.0092|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of \[6S\]-5-methyl-THF concentration in tumor was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0092
72496282|NCT04426695|144522427|SUPERIORITY|||||||0.1802|||||||stratified log-rank test|||||||0.1802
72496283|NCT04426695|144522427|SUPERIORITY|||||||0.0407|||||||stratified log-rank test|||||||0.0407
72496284|NCT04426695|144522427|SUPERIORITY|||||||0.0523|||||||stratified log-rank test|||||||0.0523
72496285|NCT04426695|144522428|SUPERIORITY|||||||0.0245|||||||ANCOVA|||||||0.0245
72496286|NCT04426695|144522428|SUPERIORITY|||||||0.0554|||||||ANCOVA|||||||0.0554
72496287|NCT04426695|144522428|SUPERIORITY|||||||0.0179|||||||ANCOVA|||||||0.0179
72496288|NCT04426695|144522428|SUPERIORITY|||||||0.0035|||||||ANCOVA|||||||0.0035
72496289|NCT04426695|144522428|SUPERIORITY|||||||0.0003|||||||ANCOVA|||||||0.0003
72496290|NCT04426695|144522428|SUPERIORITY|||||||0.0002|||||||ANCOVA|||||||0.0002
72496291|NCT04426695|144522429|SUPERIORITY|||||||0.0013|||||||ANCOVA|||||||0.0013
72496292|NCT04426695|144522429|SUPERIORITY|||||||0.001|||||||ANCOVA|||||||0.0010
72496293|NCT04426695|144522429|SUPERIORITY|||||||0.0002|||||||ANCOVA|||||||0.0002
72496294|NCT04426695|144522429|SUPERIORITY|||||||0.025|||||||ANCOVA|||||||0.0250
72387895|NCT01681472|144284307|SUPERIORITY|||||||0.8303|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of \[6S\]-5-methyl-THF concentration in tumor was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.8303
72387896|NCT01681472|144284307|SUPERIORITY|||||||0.1182|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of \[6S\]-5-methyl-THF concentration in tumor was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.1182
72387897|NCT01681472|144284307|SUPERIORITY|||||||0.0081|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of \[6S\]-5-methyl-THF concentration in tumor was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0081
72387898|NCT01681472|144284307|SUPERIORITY|||||||0.3184|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of \[6S\]-5-methyl-THF concentration in tumor was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.3184
72387899|NCT01681472|144284307|SUPERIORITY|||||||0.1752|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of \[6S\]-5-methyl-THF concentration in tumor was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.1752
72387900|NCT01681472|144284308|SUPERIORITY|||||||0.0728|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of \[6S\]-5-methyl-THF concentration in mucosa adjacent to the tumor was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0728
72387901|NCT01681472|144284308|SUPERIORITY|||||||0.2246|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of \[6S\]-5-methyl-THF concentration in mucosa adjacent to the tumor was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.2246
72387902|NCT01681472|144284308|SUPERIORITY|||||||0.0428|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of \[6S\]-5-methyl-THF concentration in mucosa adjacent to the tumor was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0428
72387903|NCT01681472|144284308|SUPERIORITY|||||||0.0003|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of \[6S\]-5-methyl-THF concentration in mucosa adjacent to the tumor was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0003
72387904|NCT01681472|144284308|SUPERIORITY|||||||0.4309|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of \[6S\]-5-methyl-THF concentration in mucosa adjacent to the tumor was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.4309
72387905|NCT01681472|144284308|SUPERIORITY|||||||0.0055|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of \[6S\]-5-methyl-THF concentration in mucosa adjacent to the tumor was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0055
72442035|NCT02554786|144397218|SUPERIORITY||Hazard Ratio (HR)|0.48|||<|0.001|TWO_SIDED|95.0|0.38|0.6|||Regression, Cox|||All asthma exacerbation||0.6|0.38|<0.001
72442036|NCT02554786|144397218|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.185|TWO_SIDED|95.0|0.66|1.08|||Regression, Cox|||All asthma exacerbation||1.08|0.66|0.185
72442037|NCT02554786|144397219|SUPERIORITY||Hazard Ratio (HR)|0.51||||0.337|TWO_SIDED|95.0|0.13|2.03|||Regression, Cox|||||2.03|0.13|0.337
72442038|NCT02554786|144397219|SUPERIORITY||Hazard Ratio (HR)|0.14||||0.063|TWO_SIDED|95.0|0.02|1.11|||Regression, Cox|||||1.11|0.02|0.063
72442039|NCT02554786|144397219|SUPERIORITY||Hazard Ratio (HR)|1.62||||0.599|TWO_SIDED|95.0|0.27|9.7|||Regression, Cox|||||9.7|0.27|0.599
72442040|NCT02554786|144397220|SUPERIORITY||Rate Ratio|0.65||||0.008|TWO_SIDED|95.0|0.48|0.89|||Generalized linear model|||Moderate or severe asthma exacerbation||0.89|0.48|0.008
72442041|NCT02554786|144397220|SUPERIORITY||Rate Ratio|0.47|||<|0.001|TWO_SIDED|95.0|0.35|0.64|||Generalized linear model|||Moderate or severe asthma exacerbation||0.64|0.35|<0.001
72442042|NCT02554786|144397220|SUPERIORITY||Rate Ratio|0.93||||0.669|TWO_SIDED|95.0|0.67|1.29|||Generalized linear model|||Moderate or severe asthma exacerbation||1.29|0.67|0.669
72442043|NCT02554786|144397220|SUPERIORITY||Rate Ratio|0.71||||0.108|TWO_SIDED|95.0|0.47|1.08|||Generalized linear model|||Severe asthma exacerbation||1.08|0.47|0.108
72442044|NCT02554786|144397220|SUPERIORITY||Rate Ratio|0.46|||<|0.001|TWO_SIDED|95.0|0.31|0.67|||Generalized linear model|||Severe asthma exacerbation||0.67|0.31|<0.001
72442045|NCT02554786|144397220|SUPERIORITY||Rate Ratio|0.89||||0.597|TWO_SIDED|95.0|0.58|1.37|||Generalized linear model|||Severe asthma exacerbation||1.37|0.58|0.597
72442046|NCT02554786|144397220|SUPERIORITY||Rate Ratio|0.67||||0.002|TWO_SIDED|95.0|0.52|0.87|||Generalized linear model|||All (mild, moderate, severe) asthma exacerbation||0.87|0.52|0.002
72442047|NCT02554786|144397220|SUPERIORITY||Rate Ratio|0.46|||<|0.001|TWO_SIDED|95.0|0.36|0.59|||Generalized linear model|||All (mild, moderate, severe) asthma exacerbation||0.59|0.36|<0.001
72442048|NCT02554786|144397220|SUPERIORITY||Rate Ratio|0.95||||0.681|TWO_SIDED|95.0|0.72|1.23|||Generalized linear model|||All (mild, moderate, severe) asthma exacerbation||1.23|0.72|0.681
72442049|NCT02554786|144397221|SUPERIORITY||||||<|0.001|||||||van Elteren test|||Moderate or severe asthma exacerbation||||<0.001
72442050|NCT02554786|144397221|SUPERIORITY||||||<|0.001|||||||van Elteren test|||Moderate or severe asthma exacerbation||||<0.001
72442051|NCT02554786|144397221|SUPERIORITY|||||||0.059|||||||van Elteren test|||Moderate or severe asthma exacerbation||||0.059
72442052|NCT02554786|144397221|SUPERIORITY|||||||0.004|||||||Van Elteren Test|||Severe Asthma Exacerbation||||0.004
72442053|NCT02554786|144397221|SUPERIORITY||||||<|0.001|||||||Van Elteren Test|||Severe Asthma Exacerbation||||<0.001
72442054|NCT02554786|144397221|SUPERIORITY|||||||0.025|||||||van Elteren test|||Severe asthma exacerbation||||0.025
72496295|NCT04426695|144522429|SUPERIORITY|||||||0.0012|||||||ANCOVA|||||||0.0012
72387906|NCT01681472|144284309|SUPERIORITY|||||||0.0728|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of \[6S\]-5-formyl-THF concentration in tumor was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0728
72387907|NCT01681472|144284309|SUPERIORITY|||||||0.0034|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of \[6S\]-5-formyl-THF concentration in tumor was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0034
72387908|NCT01681472|144284309|SUPERIORITY|||||||0.0015|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of \[6S\]-5-formyl-THF concentration in tumor was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0015
72387909|NCT01681472|144284309|SUPERIORITY|||||||0.0024|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of \[6S\]-5-formyl-THF concentration in tumor was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0024
72387910|NCT01681472|144284309|SUPERIORITY|||||||0.0009|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of \[6S\]-5-formyl-THF concentration in tumor was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0009
72387911|NCT01681472|144284309|SUPERIORITY|||||||0.0055|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of \[6S\]-5-formyl-THF concentration in tumor was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0055
72387912|NCT01681472|144284310|SUPERIORITY|||||||0.024|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of \[6S\]-5-formyl-THF concentration in mucosa adjacent to the tumor was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0240
72387913|NCT01681472|144284310|SUPERIORITY|||||||0.0058|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of \[6S\]-5-formyl-THF concentration in mucosa adjacent to the tumor was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0058
72387914|NCT01681472|144284310|SUPERIORITY|||||||0.0015|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of \[6S\]-5-formyl-THF concentration in mucosa adjacent to the tumor was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0015
72387915|NCT01681472|144284310|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of \[6S\]-5-formyl-THF concentration in mucosa adjacent to the tumor was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||<0.0001
72387916|NCT01681472|144284310|SUPERIORITY|||||||0.0014|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of \[6S\]-5-formyl-THF concentration in mucosa adjacent to the tumor was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0014
72387917|NCT01681472|144284310|SUPERIORITY|||||||0.0338|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of \[6S\]-5-formyl-THF concentration in mucosa adjacent to the tumor was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0338
72387918|NCT01681472|144284311|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(0-2h) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
72387919|NCT01681472|144284311|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(0-2h) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
72387920|NCT01681472|144284311|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(0-2h) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
72387921|NCT01681472|144284311|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(0-2h) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
72442055|NCT02554786|144397221|SUPERIORITY|||||||0.002|||||||Van Elteren Test|||All(mild, moderate, severe) Asthma Exacerbation||||0.002
72442056|NCT02554786|144397221|SUPERIORITY||||||<|0.001|||||||Van Elteren Test|||All (mild, moderate, severe) Asthma Exacerbation||||<0.001
72442057|NCT02554786|144397221|SUPERIORITY|||||||0.074|||||||van Elteren test|||All (mild, moderate, severe) asthma exacerbation||||0.074
72442058|NCT02554786|144397223|SUPERIORITY||Hazard Ratio (HR)|0.26||||0.222|TWO_SIDED|95.0|0.03|2.29|||Regression, Cox|||||2.29|0.03|0.222
72442059|NCT02554786|144397223|SUPERIORITY||Hazard Ratio (HR)|0.0||||0.992|TWO_SIDED|95.0|0.0||The upper limit of CI could not be calculated due to low number of participants with asthma exacerbation.||Regression, Cox||||||0|0.992
72442060|NCT02554786|144397223|SUPERIORITY||Hazard Ratio (HR)|0.54||||0.618|TWO_SIDED|95.0|0.05|6.01|||Regression, Cox|||||6.01|0.05|0.618
72442061|NCT02554786|144397226|SUPERIORITY||LS Mean|10.1|STANDARD_ERROR_OF_MEAN|2.02|<|0.001|TWO_SIDED|95.0|6.2|14.1|||LMM|||Weeks 1-26||14.1|6.2|< 0.001
72442062|NCT02554786|144397226|SUPERIORITY||LS Mean|8.3|STANDARD_ERROR_OF_MEAN|2.02|<|0.001|TWO_SIDED|95.0|4.3|12.3|||LMM|||Weeks 1-26||12.3|4.3|<0.001
72442063|NCT02554786|144397226|SUPERIORITY||LS Mean|4.1|STANDARD_ERROR_OF_MEAN|2.02||0.045|TWO_SIDED|95.0|0.1|8.0|||LMM|||Weeks 1-26||8|0.1|0.045
72442064|NCT02554786|144397226|SUPERIORITY||LS Mean|9.6|STANDARD_ERROR_OF_MEAN|2.03|<|0.001|TWO_SIDED|95.0|5.7|13.6|||LMM|||Weeks 1-52||13.6|5.7|<0.001
72442065|NCT02554786|144397226|SUPERIORITY||LS Mean|8.6|STANDARD_ERROR_OF_MEAN|2.03|<|0.001|TWO_SIDED|95.0|4.7|12.6|||LMM|||Weeks 1-52||12.6|4.7|<0.001
72387922|NCT01681472|144284311|SUPERIORITY|||||||0.0015|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(0-2h) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0015
72387923|NCT01681472|144284311|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(0-2h) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
72387924|NCT01681472|144284312|SUPERIORITY|||||||0.0015|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(0-2h) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0015
72387925|NCT01681472|144284312|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(0-2h) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
72387926|NCT01681472|144284312|SUPERIORITY|||||||0.0015|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(0-2h) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0015
72387927|NCT01681472|144284312|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(0-2h) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
72387928|NCT01681472|144284312|SUPERIORITY|||||||0.0009|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(0-2h) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0009
72387929|NCT01681472|144284312|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(0-2h) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
72387930|NCT01681472|144284313|SUPERIORITY|||||||0.0728|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(0-2h) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0728
72387931|NCT01681472|144284313|SUPERIORITY|||||||0.2246|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(0-2h) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.2246
72387932|NCT01681472|144284313|SUPERIORITY|||||||0.0166|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(0-2h) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0166
72387933|NCT01681472|144284313|SUPERIORITY|||||||0.1752|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(0-2h) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.1752
72387934|NCT01681472|144284313|SUPERIORITY|||||||0.9581|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(0-2h) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.9581
72387935|NCT01681472|144284313|SUPERIORITY|||||||0.0118|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(0-2h) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0118
72387936|NCT01681472|144284314|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(0-2h) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
72387937|NCT01681472|144284314|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(0-2h) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
72387938|NCT01681472|144284314|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(0-2h) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
72387939|NCT01681472|144284314|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(0-2h) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
72387940|NCT01681472|144284314|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(0-2h) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
72387941|NCT01681472|144284314|SUPERIORITY|||||||0.0024|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(0-2h) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0024
72387942|NCT01681472|144284315|SUPERIORITY|||||||0.0015|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0015
72387943|NCT01681472|144284315|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
72442066|NCT02554786|144397226|SUPERIORITY||LS Mean|4.3|STANDARD_ERROR_OF_MEAN|2.04||0.034|TWO_SIDED|95.0|0.3|8.3|||LMM|||Weeks 1-52||8.3|0.3|0.034
72496296|NCT04426695|144522429|SUPERIORITY|||||||0.0014|||||||ANCOVA|||||||0.0014
72442067|NCT02554786|144397227|SUPERIORITY||LS Mean|0.147|STANDARD_ERROR_OF_MEAN|0.0462||0.002|TWO_SIDED|95.0|0.056|0.237|||MMRM|||Day 30||0.237|0.056|0.002
72442068|NCT02554786|144397227|SUPERIORITY||LS Mean|0.123|STANDARD_ERROR_OF_MEAN|0.0464||0.008|TWO_SIDED|95.0|0.032|0.214|||MMRM|||Day 30||0.214|0.032|0.008
72442069|NCT02554786|144397227|SUPERIORITY||LS Mean|0.045|STANDARD_ERROR_OF_MEAN|0.046||0.33|TWO_SIDED|95.0|-0.045|0.135|||MMRM|||Day 30||0.135|-0.045|0.33
72559358|NCT00577655|144648288|SUPERIORITY_OR_OTHER_LEGACY||ratio of Active to Placebo|0.887||||0.8326|TWO_SIDED|95.0|-0.111|1.885||significance level of 0.05.|mixed poisson regression model|||"Week 3~P-value, mean and confidence interval calculated from a 0 inflated mixed poisson regression model with fixed effect terms for treatment, week, treatment by week interaction, baseline as a covariate and a random term for subject. The null hypothesis is that the ratio equals 1. Estimated means are conditional upon the random effect, assume a random effect of 0 and a covariate value at the average."||1.885|-0.111|0.8326
72559359|NCT01087502|144648300|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.42|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001||95.0|-0.6|-0.24|||ANCOVA|||||-0.24|-0.60|<0.0001
72559360|NCT01087502|144648302|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.29|STANDARD_ERROR_OF_MEAN|6.59||0.1602||95.0|-22.28|3.7|||ANCOVA|||||3.7|-22.28|0.1602
72442070|NCT02554786|144397227|SUPERIORITY||LS Mean|0.054|STANDARD_ERROR_OF_MEAN|0.0503||0.28|TWO_SIDED|95.0|-0.044|0.153|||MMRM|||Day 86||0.153|-0.044|0.28
72442071|NCT02554786|144397227|SUPERIORITY||LS Mean|0.118|STANDARD_ERROR_OF_MEAN|0.0507||0.02|TWO_SIDED|95.0|0.019|0.217|||MMRM|||Day 86||0.217|0.019|0.02
72442072|NCT02554786|144397227|SUPERIORITY||LS Mean|0.026|STANDARD_ERROR_OF_MEAN|0.0501||0.598|TWO_SIDED|95.0|-0.072|0.125|||MMRM|||Day 86||0.125|-0.072|0.598
72442073|NCT02554786|144397227|SUPERIORITY||LS Mean|0.127|STANDARD_ERROR_OF_MEAN|0.0526||0.016|TWO_SIDED|95.0|0.023|0.23|||MMRM|||Day 183||0.23|0.023|0.016
72442074|NCT02554786|144397227|SUPERIORITY||LS Mean|0.156|STANDARD_ERROR_OF_MEAN|0.0529||0.003|TWO_SIDED|95.0|0.053|0.26|||MMRM|||Day 183||0.26|0.053|0.003
72442075|NCT02554786|144397227|SUPERIORITY||LS Mean|0.085|STANDARD_ERROR_OF_MEAN|0.0525||0.103|TWO_SIDED|95.0|-0.017|0.188|||MMRM|||Day 183||0.188|-0.017|0.103
72442076|NCT02554786|144397227|SUPERIORITY||LS Mean|0.071|STANDARD_ERROR_OF_MEAN|0.0542||0.188|TWO_SIDED|95.0|-0.035|0.178|||MMRM|||Day 254||0.178|-0.035|0.188
72442077|NCT02554786|144397227|SUPERIORITY||LS Mean|0.168|STANDARD_ERROR_OF_MEAN|0.0543||0.002|TWO_SIDED|95.0|0.061|0.274|||MMRM|||Day 254||0.274|0.061|0.002
72442078|NCT02554786|144397227|SUPERIORITY||LS Mean|0.061|STANDARD_ERROR_OF_MEAN|0.0538||0.258|TWO_SIDED|95.0|-0.045|0.166|||MMRM|||Day 254||0.166|-0.045|0.258
72442079|NCT02554786|144397227|SUPERIORITY||LS Mean|0.079|STANDARD_ERROR_OF_MEAN|0.0552||0.154|TWO_SIDED|95.0|-0.03|0.187|||MMRM|||Day 364||0.187|-0.030|0.154
72442080|NCT02554786|144397227|SUPERIORITY||LS Mean|0.191|STANDARD_ERROR_OF_MEAN|0.0553|<|0.001|TWO_SIDED|95.0|0.082|0.299|||MMRM|||Day 364||0.299|0.082|<0.001
72442081|NCT02554786|144397227|SUPERIORITY||LS Mean|0.041|STANDARD_ERROR_OF_MEAN|0.0548||0.455|TWO_SIDED|95.0|-0.067|0.148|||MMRM|||Day 364||0.148|-0.067|0.455
72442082|NCT02554786|144397228|NON_INFERIORITY|QMF 150/320 was considered non-inferior to S/F 50/500 if the lower bound of the 95% CI was above the non-inferiority margin of -90 mL and was considered superior if the lower bound of the 95% CI was \> 0. The p-value is for null-hypothesis testing.|LS Mean|0.036|STANDARD_ERROR_OF_MEAN|0.0222||0.101|TWO_SIDED|95.0|-0.007|0.08|||MMRM|||||0.080|-0.007|0.101
72442083|NCT05052996|144397234|OTHER||Difference in percentage|1.9|||||TWO_SIDED|95.0|-6.8|11.6|||||The difference in percentages between treatment groups and their 95% CI were calculated based on unconditional exact method using 2 inverted 1-sided tests.|||11.6|-6.8|
72442084|NCT05052996|144397235|OTHER||Difference in percentage|-1.9|||||TWO_SIDED|95.0|-12.4|8.6|||||The difference in percentages between treatment groups and their 95% CI were calculated based on unconditional exact method using 2 inverted 1-sided tests.|||8.6|-12.4|
72442085|NCT05052996|144397236|OTHER||Difference in percentage|1.9|||||TWO_SIDED|95.0|-8.6|12.4|||||The difference in percentages between treatment groups and their 95% CI were calculated based on unconditional exact method using 2 inverted 1-sided tests.|||12.4|-8.6|
72442086|NCT05052996|144397237|OTHER||difference in least squares means|-68.0||||0.3859|TWO_SIDED|95.0|-226.0|91.0|||ANOVA||P-value, difference in least squares means (Diff in LSM), and its 95% confidence interval (CI) were from ANOVA model with treatment group as a fixed effect in the model.|||91|-226|0.3859
72442087|NCT05052996|144397237|OTHER||difference in least squares means|13.0||||0.7085|TWO_SIDED|95.0|-56.0|82.0|||ANCOVA||P-value, difference in least squares means (Diff in LSM), and its 95% CI were from ANCOVA model with baseline value as a covariate and treatment as a fixed effect in the model.|||82|-56|0.7085
72442088|NCT05052996|144397238|OTHER||difference in least squares means|33.0||||0.3477|TWO_SIDED|95.0|-37.0|103.0|||ANCOVA||P-value, difference in least squares means (Diff in LSM), and its 95% CI were from ANCOVA model with baseline value as a covariate and treatment as a fixed effect in the model.|||103|-37|0.3477
72442089|NCT05052996|144397239|OTHER||difference in least squares means|-5.0||||0.8849|TWO_SIDED|95.0|-76.0|66.0|||ANCOVA||P-value, difference in least squares means (Diff in LSM), and its 95% CI were from ANCOVA model with baseline value as a covariate and treatment as a fixed effect in the model.|||66|-76|0.8849
72442090|NCT03351699|144397251|SUPERIORITY|Adjusted by Placebo data pooled from historical placebo data from recent monotherapy studies in HIV-1 infected participants (NCT00100048, NCT01466985, NCT01152255, and NCT01353898) and fitted with a longitudinal data analysis (LDA) model containing fixed effects for study and time, and a random effect for participants. LS mean (95% confidence interval) for change from baseline at 168 hours post dose of pooled historical placebo was -0.03 log10 copies/mL (-0.14, 0.09).|Posterior Mean Difference|-1.53|||||||||||||Posterior Probability (PP) of true mean difference in the plasma HIV-1 RNA change from baseline between MK-4250 and placebo at least 1.4 log10 copies/mL was 78%.|||||
72496297|NCT04426695|144522430|SUPERIORITY|||||||0.0623|||||||MMRM|||Difference vs. Placebo by Day 29||||0.0623
72496298|NCT04426695|144522430|SUPERIORITY|||||||0.0203|||||||MMRM|||Difference vs. Placebo by Day 29||||0.0203
72496299|NCT04426695|144522430|SUPERIORITY|||||||0.0193|||||||MMRM|||Difference vs. Placebo by Day 29||||0.0193
72496300|NCT04426695|144522430|SUPERIORITY|||||||0.1206|||||||MMRM|||Difference vs. Placebo by Day 29||||0.1206
72559361|NCT01151618|144648308|OTHER|"Sensitivity and Specificity of values with respect to the Mead Whittenberger method were computed as follows (FL=flow limited and NFL = Non Flow limited):~Sensitivity = (# of FL breaths detected by FOT / # of FL breaths detected by M\&W) \* 100 Specificity =(# of NFL breaths detected by FOT / # of NFL breaths detected by M\&W) \* 100"|DeltaXrs (cmH2O*s/L)|2.6|||||TWO_SIDED|90.0|0.0|100.0|||||DeltaXrs equals average inspiratory reactance minus average expiratory reactance.|||100|0|
72559362|NCT00380588|144648318|SUPERIORITY_OR_OTHER|||||||0.38||95.0||||P-value for response (Complete Response + Partial Response).|Fisher Exact|||||||0.380
72559363|NCT00380588|144648319|SUPERIORITY_OR_OTHER|||||||0.074||95.0|||||Log Rank|||||||0.074
72559364|NCT00380588|144648320|SUPERIORITY_OR_OTHER|||||||0.136||95.0|||||Log Rank|||||||0.136
72559365|NCT01120028|144648371|OTHER||Hazard Ratio (HR)|0.42|||<|0.0001|TWO_SIDED|95.0|0.28|0.64|||Log Rank|||||0.64|0.28|<0.0001
72387944|NCT01681472|144284315|SUPERIORITY|||||||0.0022|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0022
72387945|NCT01681472|144284315|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
72387946|NCT01681472|144284315|SUPERIORITY|||||||0.0015|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0015
72387947|NCT01681472|144284315|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
72387948|NCT01681472|144284316|SUPERIORITY|||||||0.0015|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0015
72387949|NCT01681472|144284316|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
72387950|NCT01681472|144284316|SUPERIORITY|||||||0.0015|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0015
72387951|NCT01681472|144284316|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
72387952|NCT01681472|144284316|SUPERIORITY|||||||0.0009|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0009
72387953|NCT01681472|144284316|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
72387954|NCT01681472|144284317|SUPERIORITY|||||||0.024|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0240
72387955|NCT01681472|144284317|SUPERIORITY|||||||0.1336|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.1336
72387956|NCT01681472|144284317|SUPERIORITY|||||||0.0015|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0015
72387957|NCT01681472|144284317|SUPERIORITY|||||||0.2725|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.2725
72387958|NCT01681472|144284317|SUPERIORITY|||||||0.1893|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.1893
72387959|NCT01681472|144284317|SUPERIORITY|||||||0.0024|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0024
72387960|NCT01681472|144284318|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
72387961|NCT01681472|144284318|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
72559366|NCT01120028|144648372|OTHER|||||||0.5|||||||ANCOVA|||||||0.5
72559367|NCT01120028|144648373|OTHER||Hazard Ratio (HR)|1.23||||0.58|TWO_SIDED|95.0|0.59|2.55|||Regression, Cox|||||2.55|0.59|0.58
72559368|NCT01120028|144648374|OTHER||Rate Ratio|1.99||||0.23|TWO_SIDED|95.0|0.64|6.18|||Log Rank|||||6.18|0.64|0.23
72559369|NCT01120028|144648375|OTHER||Rate Ratio|1.02||||0.88|TWO_SIDED|95.0|0.8|1.29|||Regression, Cox|||||1.29|0.80|0.88
72559370|NCT01120028|144648376|OTHER||Rate ratio|1.51||||0.008|TWO_SIDED|95.0|1.11|2.06|||Log Rank|||||2.06|1.11|0.008
72442091|NCT03351699|144397251|SUPERIORITY|Adjusted by Placebo data pooled from historical placebo data from recent monotherapy studies in HIV-1 infected participants (NCT00100048, NCT01466985, NCT01152255, and NCT01353898) and fitted with a longitudinal data analysis (LDA) model containing fixed effects for study and time, and a random effect for participants. LS mean (95% confidence interval) for change from baseline at 168 hours post dose of pooled historical placebo was -0.03 log10 copies/mL (-0.14, 0.09).|Posterior Mean Difference|-1.73|||||||||||||Posterior Probability (PP) of true mean difference in the plasma HIV-1 RNA change from baseline between MK-4250 and placebo at least 1.4 log10 copies/mL was 95%.|||||
72442092|NCT03351699|144397251|SUPERIORITY|Adjusted by Placebo data pooled from historical placebo data from recent monotherapy studies in HIV-1 infected participants (NCT00100048, NCT01466985, NCT01152255, and NCT01353898) and fitted with a longitudinal data analysis (LDA) model containing fixed effects for study and time, and a random effect for participants. LS mean (95% confidence interval) for change from baseline at 168 hours post dose of pooled historical placebo was -0.03 log10 copies/mL (-0.14, 0.09).|Posterior Mean Difference|-1.52|||||||||||||Posterior Probability (PP) of true mean difference in the plasma HIV-1 RNA change from baseline between MK-4250 and placebo at least 1.4 log10 copies/mL was 75%.|||||
72442093|NCT03351699|144397251|SUPERIORITY|Adjusted by Placebo data pooled from historical placebo data from recent monotherapy studies in HIV-1 infected participants (NCT00100048, NCT01466985, NCT01152255, and NCT01353898) and fitted with a longitudinal data analysis (LDA) model containing fixed effects for study and time, and a random effect for participants. LS mean (95% confidence interval) for change from baseline at 168 hours post dose of pooled historical placebo was -0.03 log10 copies/mL (-0.14, 0.09).|Posterior Mean Difference|-1.75|||||||||||||Posterior Probability (PP) of true mean difference in the plasma HIV-1 RNA change from baseline between MK-4250 and placebo at least 1.4 log10 copies/mL was 96%.|||||
72559371|NCT01120028|144648377|OTHER||Rate Ratio|1.0||||0.99|TWO_SIDED|95.0|0.51|1.97|||Log Rank|||||1.97|0.51|0.99
72559372|NCT01120028|144648378|OTHER||Rate Ratio|0.76||||0.52|TWO_SIDED|95.0|0.34|1.73|||Log Rank|||||1.73|0.34|0.52
72559373|NCT03867760|144648379|SUPERIORITY|The study was designed to detect a difference in pain intensity of at least 0.85 points corresponding to an effect size of 0.57 based on results from our pilot study. The sample size needed was 50 per group based on power of .80, alpha of .05.||||||0.809||||||An a priori significance level was set at 0.05.|ANCOVA|We controlled for pre-treatment scores in addition to baseline pain medications in the ANCOVA analysis.||Null Hypothesis: Cancer survivors with chronic pain assigned to the daily use of the hypnosis intervention for 28 days will not report significantly greater pre- to post-treatment decreases in pain intensity than cancer survivors assigned to the relaxation intervention.||||0.809
72559374|NCT03867760|144648380|SUPERIORITY|||||||0.369||||||An a priori significance level was set at 0.05.|ANCOVA|We controlled for pre-treatment scores in addition to baseline pain medications in the ANCOVA analysis.||Null Hypothesis: Cancer survivors with chronic pain assigned to the daily use of the hypnosis intervention for 28 days will not report significantly greater pre- to post-treatment decreases in pain interference than cancer survivors assigned to the relaxation intervention.||||0.369
72559375|NCT03867760|144648381|SUPERIORITY|||||||0.029||||||An a priori significance level was set at 0.05.|ANCOVA|We controlled for pre-treatment scores in the ANCOVA analysis.||Null Hypothesis: Cancer survivors with chronic pain assigned to the daily use of the hypnosis intervention for 28 days will not report significantly greater pre- to post-treatment decreases in anxiety than cancer survivors assigned to the relaxation intervention.||||0.029
72559376|NCT03867760|144648382|SUPERIORITY|||||||0.236||||||An a priori significance level was set at 0.05.|ANCOVA|We controlled for pre-treatment scores in the ANCOVA analysis.||Null Hypothesis: Cancer survivors with chronic pain assigned to the daily use of the hypnosis intervention for 28 days will not report significantly greater pre- to post-treatment decreases in depression than cancer survivors assigned to the relaxation intervention.||||0.236
72442094|NCT02570022|144397264|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.05|||<|0.05|TWO_SIDED||||||t-test, 2 sided||This analysis corresponds to the visual analog scale and morphine equivalent data.|Our hypothesis was that in patients undergoing shoulder arthroplasty, treatment with LB would lead to no significant differences in average daily pain scores. A power analysis was performed prior to the study to assess the primary hypothesis that a significant difference in average daily pain of 13mm on VAS will not be found between the INB and LB groups. With a power of 80% (beta level = 0.80, alpha level = 0.05), a sample size of 25 patients per group was obtained||||<0.05
72442095|NCT00041938|144397266|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.93||||0.4|TWO_SIDED|95.0|0.79|1.1||The primary null hypotheses was tested at two-tailed alpha=0.05. A Haybittle-Peto interim monitoring procedure was performed with stopping boundaries for the interim analyses corresponding to a nominal two-tailed P value of 0.001.|Regression, Cox|Cox models stratified by site, New York Heart Association class (I vs. II-IV), and status w/ respect to recent stroke or Transient Ischemic Attack.|Hazard ratio is for comparison of warfarin vs. aspirin. Warfarin represents the numerator and aspirin represents the denominator of the hazard ratio.|The primary null hypothesis: time to first event in the composite primary endpoint does not differ significantly between warfarin and aspirin. The original target sample size was 2860, providing 89% power for a log-rank test with two-sided alpha .05, assuming a hazard rate reduction of 17.82% in either group compared with the other, after adjustment for use of beta-blockers and allowance for discontinuation of therapy, dropout, and crossover. The final sample of 2305 patients yielded 69% power.||1.10|0.79|0.40
72442096|NCT00041938|144397267|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.07||||0.33|TWO_SIDED|95.0|0.93|1.23||Secondary null hypothesis was tested at two-tailed alpha = 0.05.|Regression, Cox|Cox models stratified by site, New York Heart Association class (I vs. II-IV), and status w/ respect to recent stroke or Transient Ischemic Attack.|Hazard ratio is for comparison of warfarin vs. aspirin. Warfarin represents the numerator and aspirin represents the denominator of the hazard ratio.|Secondary null hypothesis: time to first event in the composite secondary endpoint does not differ significantly between warfarin and aspirin. This was tested at prespecified alpha = 0.05 level, two-tailed.||1.23|0.93|0.33
72496301|NCT04426695|144522430|SUPERIORITY|||||||0.0911|||||||MMRM|||Difference vs. Placebo by Day 29||||0.0911
72496302|NCT04426695|144522430|SUPERIORITY|||||||0.0645|||||||MMRM|||Difference vs. Placebo by Day 29||||0.0645
72496303|NCT04426695|144522431|SUPERIORITY|||||||0.0623|||||||MMRM|||Percent Difference vs. Placebo at Day 29||||0.0623
72387962|NCT01681472|144284318|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
72387963|NCT01681472|144284318|SUPERIORITY|||||||0.0142|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0142
72387964|NCT01681472|144284318|SUPERIORITY|||||||0.0085|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0085
72387965|NCT01681472|144284318|SUPERIORITY|||||||0.0024|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0024
72387966|NCT01681472|144284319|SUPERIORITY|||||||0.0014|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of Cmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0014
72387967|NCT01681472|144284319|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of Cmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
72387968|NCT01681472|144284319|SUPERIORITY|||||||0.0021|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of Cmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0021
72387969|NCT01681472|144284319|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of Cmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
72387970|NCT01681472|144284319|SUPERIORITY|||||||0.0014|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of Cmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0014
72387971|NCT01681472|144284319|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of Cmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
72387972|NCT01681472|144284320|SUPERIORITY|||||||0.0015|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of Cmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0015
72387973|NCT01681472|144284320|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of Cmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
72387974|NCT01681472|144284320|SUPERIORITY|||||||0.0015|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of Cmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0015
72387975|NCT01681472|144284320|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of Cmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
72387976|NCT01681472|144284320|SUPERIORITY|||||||0.0009|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of Cmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0009
72387977|NCT01681472|144284320|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of Cmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
72387978|NCT01681472|144284321|SUPERIORITY|||||||0.024|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of Cmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0240
72387979|NCT01681472|144284321|SUPERIORITY|||||||0.1336|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of Cmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.1336
72387980|NCT01681472|144284321|SUPERIORITY|||||||0.0015|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of Cmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0015
72387981|NCT01681472|144284321|SUPERIORITY|||||||0.1551|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of Cmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.1551
72442097|NCT00041938|144397268|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.52||||0.005|TWO_SIDED|95.0|0.33|0.82|||Regression, Cox|Cause-specific Cox model, stratified by site, NYHA class (I vs. II, III, or IV), and prior stroke or TIA status.|Hazard ratio is for comparison of warfarin vs. aspirin. Warfarin represents the numerator and aspirin represents the denominator of the hazard ratio.|Null hypothesis: there is no difference between warfarin and aspirin in time to ischemic stroke, adjusting for competing risks of death and intracerebral hemorrhage.||0.82|0.33|0.005
72442098|NCT00041938|144397269|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.22||||0.35||95.0|0.43|11.66|||Regression, Cox|Cause-specific Cox model, stratified by site, NYHA class (I vs. II, III, or IV), and prior stroke or TIA status.||Null hypothesis: there is no difference between warfarin and aspirin in time to intracerebral hemorrhage, adjusting for competing risks of death and ischemic stroke.||11.66|0.43|0.35
72559377|NCT03867760|144648383|SUPERIORITY|||||||0.904||||||An a priori significance level was set at 0.05.|ANCOVA|We controlled for pre-treatment scores in the ANCOVA analysis.||Null Hypothesis: Cancer survivors with chronic pain assigned to the daily use of the hypnosis intervention for 28 days will not report significantly greater pre- to post-treatment decreases in fatigue than cancer survivors assigned to the relaxation intervention.||||0.904
72559378|NCT03867760|144648384|SUPERIORITY|||||||0.936||||||An a priori significance level was set at 0.05.|ANCOVA|We controlled for pre-treatment scores in the ANCOVA analysis.||Null Hypothesis: Cancer survivors with chronic pain assigned to the daily use of the hypnosis intervention for 28 days will not report significantly greater pre- to post-treatment decreases in sleep disturbance than cancer survivors assigned to the relaxation intervention.||||0.936
72559379|NCT03867760|144648385|SUPERIORITY|||||||0.02||||||An a priori significance level was set at 0.05.|t-test, 2 sided|||Null Hypothesis: Cancer survivors with chronic pain assigned to the daily use of the hypnosis intervention who experience a clinically meaningful improvement in pain intensity will not have a significantly higher pre-treatment treatment credibility and expectancy score than non-improvers.||||0.02
72559380|NCT03247686|144648395|SUPERIORITY|||||||4.96e-05|||||||t-test, 2 sided|||Module M1.2 Placebo versus RSLV-132 All||||0.0000496
72559381|NCT03247686|144648395|SUPERIORITY|||||||1.03e-05|||||||t-test, 2 sided|||Module M3.4 Placebo versus RSLV-132 All||||0.0000103
72559382|NCT03247686|144648395|SUPERIORITY|||||||0.0004398|||||||t-test, 2 sided|||Module M5.12 Placebo versus RSLV-132 All||||0.0004398
72559383|NCT03247686|144648395|SUPERIORITY|||||||6.8e-06|||||||t-test, 2 sided|||Module 1.2 Placebo versus RSLV-132 Responders||||0.0000068
72442099|NCT00041938|144397270|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.01||||0.91|TWO_SIDED|95.0|0.85|1.2|||Regression, Cox|Cause-specific Cox model, stratified by site, NYHA class (I vs. II, III, or IV), and prior stroke or TIA status.|Hazard ratio is for comparison of warfarin vs. aspirin. Warfarin represents the numerator and aspirin represents the denominator of the hazard ratio.|||1.20|0.85|0.91
72559384|NCT03247686|144648395|SUPERIORITY|||||||2e-07|||||||t-test, 2 sided|||Module M3.4 Placebo versus RSLV-132 Responders||||0.0000002
72559385|NCT03247686|144648395|SUPERIORITY|||||||9.26e-05|||||||t-test, 2 sided|||Module 5.12 Placebo versus RSLV-132 Responders||||0.0000926
72559386|NCT03247686|144648395|SUPERIORITY|||||||0.001545|||||||t-test, 2 sided|||Module M1.2 Placebo versus RSLV-132 Non-responders||||0.0015450
72559387|NCT03247686|144648395|SUPERIORITY|||||||0.0004632|||||||t-test, 2 sided|||Module M3.4 Placebo versus RSLV-132 Non-responders||||0.0004632
72559388|NCT03247686|144648395|SUPERIORITY|||||||0.009696|||||||t-test, 2 sided|||Module M5.12||||0.0096960
72559389|NCT03247686|144648396|EQUIVALENCE|Two sample t-test with Satterthwaite approximation|Mean Difference (Final Values)|-2.5||||0.18|TWO_SIDED|95.0|-6.34|1.34|||t-test, 2 sided|||Mean difference in change from baseline (95% CI)||1.34|-6.34|0.180
72559390|NCT02583048|144648406|SUPERIORITY||Mean Difference (Net)|8.4|||||TWO_SIDED|95.1|2.0|14.8|||||Arm 3 minus Arm 1 difference in change from baseline estimated from ANOVA model. Interim analysis conducted when week 24 QT data was available for ≥12 participants stipulated 99.9% confidence interval; original coverage of 95% was widened to 95.1%.|||14.8|2.0|
72559391|NCT02583048|144648406|SUPERIORITY||Mean Difference (Net)|12.1|||||TWO_SIDED|95.1|5.7|18.6|||||Arm 3 minus Arm 2 difference in change from baseline estimated from ANOVA model. Interim analysis conducted when week 24 QT data was available for ≥12 participants stipulated 99.9% confidence interval; original coverage of 95% was widened to 95.1%.|||18.6|5.7|
72442100|NCT00041938|144397271|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.98||||0.93|TWO_SIDED|95.0|0.58|1.64|||Regression, Cox|Cause-specific Cox model, stratified by site, NYHA class (I vs. II, III, or IV), and prior stroke or TIA status.|Hazard ratio is for comparison of warfarin vs. aspirin. Warfarin represents the numerator and aspirin represents the denominator of the hazard ratio.|Null hypothesis: there is no difference between warfarin and aspirin in time to myocardial infarction, adjusting for competing risks of heart failure hospitalization, ischemic stroke, intracerebral hemorrhage, and death.||1.64|0.58|0.93
72559392|NCT02583048|144648413|EQUIVALENCE|GMRs were compared to no effect boundaries of 0.67 to 1.50.|Geometric Mean Ratio|1.117|||||TWO_SIDED|90.0|0.884|1.411|||||The numerator represents Arm 3 and the denominator represents Arm 1.|Statistical analysis for Week 2.||1.411|0.884|
72559393|NCT02583048|144648413|EQUIVALENCE|GMRs were compared to no effect boundaries of 0.67 to 1.50.|Geometric Mean Ratio|1.202|||||TWO_SIDED|90.0|0.989|1.461|||||The numerator represents Arm 3 and the denominator represents Arm 1.|Statistical analysis for Week 8.||1.461|0.989|
72559394|NCT02583048|144648413|EQUIVALENCE|GMRs were compared to no effect boundaries of 0.67 to 1.50.|Geometric Mean Ratio|0.958|||||TWO_SIDED|90.0|0.774|1.187|||||The numerator represents Arm 3 and the denominator represents Arm 1.|Statistical analysis for Week 24.||1.187|0.774|
72559395|NCT02583048|144648414|EQUIVALENCE|GMRs were compared to no effect boundaries of 0.67 to 1.50.|Geometric Mean Ratio|0.986|||||TWO_SIDED|90.0|0.801|1.215|||||The numerator represents Arm 3 and the denominator represents Arm 1.|Statistical analysis for Week 2.||1.215|0.801|
72559396|NCT02583048|144648414|EQUIVALENCE|GMRs were compared to no effect boundaries of 0.67 to 1.50.|Geometric Mean Ratio|0.978|||||TWO_SIDED|90.0|0.764|1.251|||||The numerator represents Arm 3 and the denominator represents Arm 1.|Statistical analysis for Week 8.||1.251|0.764|
72559397|NCT02583048|144648414|EQUIVALENCE|GMRs were compared to no effect boundaries of 0.67 to 1.50.|Geometric Mean Ratio|0.859|||||TWO_SIDED|90.0|0.667|1.108|||||The numerator represents Arm 3 and the denominator represents Arm 1.|Statistical analysis for Week 24.||1.108|0.667|
72559398|NCT02583048|144648415|EQUIVALENCE|GMRs were compared to no effect boundaries of 0.67 to 1.50.|Geometric Mean Ratio|1.036|||||TWO_SIDED|90.0|0.847|1.267|||||The numerator represents Arm 3 and the denominator represents Arm 1.|Statistical analysis for Week 2.||1.267|0.847|
72559399|NCT02583048|144648415|EQUIVALENCE|GMRs were compared to no effect boundaries of 0.67 to 1.50.|Geometric Mean Ratio|1.037|||||TWO_SIDED|90.0|0.843|1.276|||||The numerator represents Arm 3 and the denominator represents Arm 1.|Statistical analysis for Week 8.||1.276|0.843|
72559400|NCT02583048|144648415|EQUIVALENCE|GMRs were compared to no effect boundaries of 0.67 to 1.50.|Geometric Mean Ratio|0.915|||||TWO_SIDED|90.0|0.727|1.151|||||The numerator represents Arm 3 and the denominator represents Arm 1.|Statistical analysis for Week 24.||1.151|0.727|
72442101|NCT00041938|144397272|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.21||||0.053|TWO_SIDED|95.0|0.998|1.47|||Regression, Cox|Cause-specific Cox model, stratified by site, NYHA class (I vs. II, III, or IV), and prior stroke or TIA status.||Null hypothesis: there is no difference between warfarin and aspirin in time to heart failure hospitalization, adjusting for competing risks of myocardial infarction, ischemic stroke, intracerebral hemorrhage, and death.||1.47|0.998|0.053
72442102|NCT00041938|144397273|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.55||||0.03|TWO_SIDED|95.0|0.32|0.96|||Regression, Cox|Cause-specific Cox model, stratified by site, NYHA class (I vs. II, III, or IV), and prior stroke or TIA status.||Null hypothesis: there is no difference between warfarin and aspirin in time to ischemic stroke, adjusting for competing risks of myocardial infarction, heart failure hospitalization, death and intracerebral hemorrhage.||0.96|0.32|0.03
72442103|NCT00041938|144397274|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.77||||0.51|TWO_SIDED|95.0|0.32|9.88|||Regression, Cox|Cause-specific Cox model, stratified by site, NYHA class (I vs. II, III, or IV), and prior stroke or TIA status.|Hazard ratio is for comparison of warfarin vs. aspirin. Warfarin represents the numerator and aspirin represents the denominator of the hazard ratio.|Null hypothesis: there is no difference between warfarin and aspirin in time to intracerebral hemorrhage, adjusting for competing risks of myocardial infarction, heart failure hospitalization, ischemic stroke, and death.||9.88|0.32|0.51
72442104|NCT00041938|144397275|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.03||||0.83||95.0|0.81|1.3|||Regression, Cox|Cause-specific Cox model, stratified by site, NYHA class (I vs. II, III, or IV), and prior stroke or TIA status.||||1.30|0.81|0.83
72442105|NCT00041938|144397276|SUPERIORITY_OR_OTHER||Rate ratio|2.05|||<|0.001|TWO_SIDED|95.0|1.36|3.12|||Regression, Poisson||The warfarin arm represents the numerator and the aspirin arm represents the denominator of the rate ratio.|||3.12|1.36|<0.001
72559401|NCT02583048|144648416|EQUIVALENCE|GMRs were compared to no effect boundaries of 0.67 to 1.50.|Geometric Mean Ratio|1.043|||||TWO_SIDED|90.0|0.864|1.258|||||The numerator represents Arm 3 and the denominator represents Arm 1.|Statistical analysis for Week 2.||1.258|0.864|
72559402|NCT02583048|144648416|EQUIVALENCE|GMRs were compared to no effect boundaries of 0.67 to 1.50.|Geometric Mean Ratio|1.029|||||TWO_SIDED|90.0|0.858|1.235|||||The numerator represents Arm 3 and the denominator represents Arm 1.|Statistical analysis for Week 8.||1.235|0.858|
72559403|NCT02583048|144648416|EQUIVALENCE|GMRs were compared to no effect boundaries of 0.67 to 1.50.|Geometric Mean Ratio|0.808|||||TWO_SIDED|90.0|0.657|0.993|||||The numerator represents Arm 3 and the denominator represents Arm 1.|Statistical analysis for Week 24.||0.993|0.657|
72622358|NCT00835042|144774578|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|98.9||||||90.0|94.6|103.0|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||103|94.6|
72442106|NCT00041938|144397277|SUPERIORITY_OR_OTHER||Rate ratio|1.56|||<|0.001||95.0|1.34|1.81|||Regression, Poisson||Warfarin group represents the numerator and aspirin group represents denominator of rate ratio.|||1.81|1.34|<0.001
72442107|NCT04515641|144397290|OTHER||GMR|0.75|||||TWO_SIDED|90.0|0.58|0.96|||||Participants with Moderate Hepatic Impairment / Healthy Matched Control Participants|Geometric least-squares mean ratio (GMR)|GMR calculated using the mean square error referencing a t-distribution. Confidence limits exponentiated to obtain the 90% confidence interval.|0.96|0.58|
72442108|NCT04515641|144397291|OTHER||GMR|0.75|||||TWO_SIDED|90.0|0.58|0.98|||||Participants with Moderate Hepatic Impairment / Healthy Matched Control Participants|Geometric least-squares mean ratio (GMR)|GMR calculated using the mean square error referencing a t-distribution. Confidence limits exponentiated to obtain the 90% confidence interval.|0.98|0.58|
72559404|NCT02583048|144648417|EQUIVALENCE|GMRs were compared to no effect boundaries of 0.67 to 1.50.|Geometric Mean Ratio|1.068|||||TWO_SIDED|90.0|0.903|1.263|||||The numerator represents Arm 3 and the denominator represents Arm 1.|Statistical analysis for Week 2.||1.263|0.903|
72442109|NCT04515641|144397292|OTHER||GMR|0.65|||||TWO_SIDED|90.0|0.38|1.14|||||Participants with Moderate Hepatic Impairment / Healthy Matched Control Participants|Geometric least-squares mean ratio (GMR)|GMR calculated using the mean square error referencing a t-distribution. Confidence limits exponentiated to obtain the 90% confidence interval.|1.14|0.38|
72442110|NCT04515641|144397299|OTHER||GMR|0.76|||||TWO_SIDED|90.0|0.57|1.0|||||Participants with Moderate Hepatic Impairment / Healthy Matched Control Participants|Geometric least-squares mean ratio (GMR)|GMR calculated using the mean square error referencing a t-distribution. Confidence limits exponentiated to obtain the 90% confidence interval.|1.00|0.57|
72442111|NCT04515641|144397300|OTHER||GMR|0.77|||||TWO_SIDED|90.0|0.58|1.03|||||Participants with Moderate Hepatic Impairment / Healthy Matched Control Participants|Geometric least-squares mean ratio (GMR)|GMR calculated using the mean square error referencing a t-distribution. Confidence limits exponentiated to obtain the 90% confidence interval.|1.03|0.58|
72442112|NCT04515641|144397301|OTHER||GMR|0.96|||||TWO_SIDED|90.0|0.63|1.46|||||Participants with Moderate Hepatic Impairment / Healthy Matched Control Participants|Geometric least-squares mean ratio (GMR)|GMR calculated using the mean square error referencing a t-distribution. Confidence limits exponentiated to obtain the 90% confidence interval.|1.46|0.63|
72442113|NCT04515641|144397302|OTHER||GMR|1.05|||||TWO_SIDED|90.0|0.65|1.71|||||Participants with Moderate Hepatic Impairment / Healthy Matched Control Participants|Geometric least-squares mean ratio (GMR)|GMR calculated using the mean square error referencing a t-distribution. Confidence limits exponentiated to obtain the 90% confidence interval.|1.71|0.65|
72442114|NCT04515641|144397303|OTHER||GMR|0.86|||||TWO_SIDED|90.0|0.59|1.26|||||Participants with Moderate Hepatic Impairment / Healthy Matched Control Participants|Geometric least-squares mean ratio (GMR)|GMR calculated using the mean square error referencing a t-distribution. Confidence limits exponentiated to obtain the 90% confidence interval.|1.26|0.59|
72442115|NCT04515641|144397304|OTHER||GMR|0.65|||||TWO_SIDED|90.0|0.42|1.01|||||Participants with Moderate Hepatic Impairment / Healthy Matched Control Participants|Geometric least-squares mean ratio (GMR)|GMR calculated using the mean square error referencing a t-distribution. Confidence limits exponentiated to obtain the 90% confidence interval.|1.01|0.42|
72496304|NCT04426695|144522431|SUPERIORITY|||||||0.0203|||||||MMRM|||Percent Difference vs. Placebo at Day 29||||0.0203
72559405|NCT02583048|144648417|EQUIVALENCE|GMRs were compared to no effect boundaries of 0.67 to 1.50.|Geometric Mean Ratio|0.973|||||TWO_SIDED|90.0|0.82|1.155|||||The numerator represents Arm 3 and the denominator represents Arm 1.|Statistical analysis for Week 8.||1.155|0.820|
72559406|NCT02583048|144648417|EQUIVALENCE|GMRs were compared to no effect boundaries of 0.67 to 1.50.|Geometric Mean Ratio|0.803|||||TWO_SIDED|90.0|0.656|0.983|||||The numerator represents Arm 3 and the denominator represents Arm 1.|Statistical analysis for Week 24.||0.983|0.656|
72559407|NCT02583048|144648418|EQUIVALENCE|GMRs were compared to no effect boundaries of 0.67 to 1.50.|Geometric Mean Ratio|1.049|||||TWO_SIDED|90.0|0.881|1.248|||||The numerator represents Arm 3 and the denominator represents Arm 1.|Statistical analysis for Week 2.||1.248|0.881|
72387982|NCT01681472|144284321|SUPERIORITY|||||||0.1563|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of Cmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.1563
72387983|NCT01681472|144284321|SUPERIORITY|||||||0.0024|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of Cmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0024
72387984|NCT01681472|144284322|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of Cmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
72387985|NCT01681472|144284322|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of Cmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
72387986|NCT01681472|144284322|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of Cmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
72387987|NCT01681472|144284322|SUPERIORITY|||||||0.0142|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of Cmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0142
72387988|NCT01681472|144284322|SUPERIORITY|||||||0.0085|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of Cmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0085
72387989|NCT01681472|144284322|SUPERIORITY|||||||0.0024|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of Cmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0024
72387990|NCT01681472|144284323|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of tmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||1.0000
72387991|NCT01681472|144284323|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of tmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
72387992|NCT01681472|144284323|SUPERIORITY|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of tmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0010
72387993|NCT01681472|144284323|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of tmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
72387994|NCT01681472|144284323|SUPERIORITY|||||||0.0005|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of tmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0005
72387995|NCT01681472|144284323|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of tmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
72387996|NCT01681472|144284324|SUPERIORITY|||||||0.0056|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of tmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0056
72387997|NCT01681472|144284324|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of tmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
72387998|NCT01681472|144284324|SUPERIORITY|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of tmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0010
72387999|NCT01681472|144284324|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of tmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
72388000|NCT01681472|144284324|SUPERIORITY|||||||0.0014|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of tmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0014
72388001|NCT01681472|144284324|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of tmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
72388002|NCT01681472|144284325|SUPERIORITY|||||||0.1796|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of tmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.1796
72559408|NCT02583048|144648418|EQUIVALENCE|GMRs were compared to no effect boundaries of 0.67 to 1.50.|Geometric Mean Ratio|0.979|||||TWO_SIDED|90.0|0.823|1.165|||||The numerator represents Arm 3 and the denominator represents Arm 1.|Statistical analysis for Week 8.||1.165|0.823|
72559409|NCT02583048|144648418|EQUIVALENCE|GMRs were compared to no effect boundaries of 0.67 to 1.50.|Geometric Mean Ratio|0.808|||||TWO_SIDED|90.0|0.638|1.025|||||The numerator represents Arm 3 and the denominator represents Arm 1.|Statistical analysis for Week 24.||1.025|0.638|
72559410|NCT02583048|144648419|EQUIVALENCE|GMRs were compared to no effect boundaries of 0.67 to 1.50.|Geometric Mean Ratio|0.903|||||TWO_SIDED|90.0|0.778|1.049|||||The numerator represents Arm 3 and the denominator represents Arm 2.|Statistical analysis for Week 2.||1.049|0.778|
72559411|NCT02583048|144648419|EQUIVALENCE|GMRs were compared to no effect boundaries of 0.67 to 1.50.|Geometric Mean Ratio|1.114|||||TWO_SIDED|90.0|0.944|1.315|||||The numerator represents Arm 3 and the denominator represents Arm 2.|Statistical analysis for Week 8.||1.315|0.944|
72559412|NCT02583048|144648419|EQUIVALENCE|GMRs were compared to no effect boundaries of 0.67 to 1.50.|Geometric Mean Ratio|0.804|||||TWO_SIDED|90.0|0.639|1.012|||||The numerator represents Arm 3 and the denominator represents Arm 2.|Statistical analysis for Week 24.||1.012|0.639|
72559413|NCT02583048|144648420|EQUIVALENCE|GMRs were compared to no effect boundaries of 0.67 to 1.50.|Geometric Mean Ratio|0.937|||||TWO_SIDED|90.0|0.81|1.084|||||The numerator represents Arm 3 and the denominator represents Arm 2.|Statistical analysis for Week 2.||1.084|0.810|
72559414|NCT02583048|144648420|EQUIVALENCE|GMRs were compared to no effect boundaries of 0.67 to 1.50.|Geometric Mean Ratio|1.107|||||TWO_SIDED|90.0|0.929|1.318|||||The numerator represents Arm 3 and the denominator represents Arm 2.|Statistical analysis for Week 8.||1.318|0.929|
72559415|NCT02583048|144648420|EQUIVALENCE|GMRs were compared to no effect boundaries of 0.67 to 1.50.|Geometric Mean Ratio|0.856|||||TWO_SIDED|90.0|0.703|1.043|||||The numerator represents Arm 3 and the denominator represents Arm 2.|Statistical analysis for Week 24.||1.043|0.703|
72559416|NCT02583048|144648421|EQUIVALENCE|GMRs were compared to no effect boundaries of 0.67 to 1.50.|Geometric Mean Ratio|0.951|||||TWO_SIDED|90.0|0.825|1.096|||||The numerator represents Arm 3 and the denominator represents Arm 2.|Statistical analysis for Week 2.||1.096|0.825|
72496305|NCT04426695|144522431|SUPERIORITY|||||||0.0193|||||||MMRM|||Percent Difference vs. Placebo at Day 29||||0.0193
72496306|NCT04426695|144522431|SUPERIORITY|||||||0.1206|||||||MMRM|||Percent Difference vs. Placebo at Day 29||||0.1206
72559417|NCT02583048|144648421|EQUIVALENCE|GMRs were compared to no effect boundaries of 0.67 to 1.50.|Geometric Mean Ratio|1.136|||||TWO_SIDED|90.0|0.948|1.362|||||The numerator represents Arm 3 and the denominator represents Arm 2.|Statistical analysis for Week 8.||1.362|0.948|
72388003|NCT01681472|144284325|SUPERIORITY|||||||0.3243|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of tmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.3243
72559418|NCT02583048|144648421|EQUIVALENCE|GMRs were compared to no effect boundaries of 0.67 to 1.50.|Geometric Mean Ratio|0.898|||||TWO_SIDED|90.0|0.727|1.109|||||The numerator represents Arm 3 and the denominator represents Arm 2.|Statistical analysis for Week 24.||1.109|0.727|
72559419|NCT02583048|144648422|EQUIVALENCE|GMRs were compared to no effect boundaries of 0.67 to 1.50.|Geometric Mean Ratio|0.939|||||TWO_SIDED|90.0|0.806|1.094|||||The numerator represents Arm 3 and the denominator represents Arm 2.|Statistical analysis for Week 2.||1.094|0.806|
72559420|NCT02583048|144648422|EQUIVALENCE|GMRs were compared to no effect boundaries of 0.67 to 1.50.|Geometric Mean Ratio|1.081|||||TWO_SIDED|90.0|0.864|1.352|||||The numerator represents Arm 3 and the denominator represents Arm 2.|Statistical analysis for Week 8.||1.352|0.864|
72559421|NCT02583048|144648422|EQUIVALENCE|GMRs were compared to no effect boundaries of 0.67 to 1.50.|Geometric Mean Ratio|0.865|||||TWO_SIDED|90.0|0.597|1.253|||||The numerator represents Arm 3 and the denominator represents Arm 2.|Statistical analysis for Week 24.||1.253|0.597|
72559422|NCT02583048|144648423|EQUIVALENCE|GMRs were compared to no effect boundaries of 0.67 to 1.50.|Geometric Mean Ratio|0.95|||||TWO_SIDED|90.0|0.825|1.095|||||The numerator represents Arm 3 and the denominator represents Arm 2.|Statistical analysis for Week 2.||1.095|0.825|
72559423|NCT02583048|144648423|EQUIVALENCE|GMRs were compared to no effect boundaries of 0.67 to 1.50.|Geometric Mean Ratio|1.08|||||TWO_SIDED|90.0|0.862|1.354|||||The numerator represents Arm 3 and the denominator represents Arm 2.|Statistical analysis for Week 8.||1.354|0.862|
72559424|NCT02583048|144648423|EQUIVALENCE|GMRs were compared to no effect boundaries of 0.67 to 1.50.|Geometric Mean Ratio|0.865|||||TWO_SIDED|90.0|0.605|1.239|||||The numerator represents Arm 3 and the denominator represents Arm 2.|Statistical analysis for Week 24.||1.239|0.605|
72559425|NCT02583048|144648424|EQUIVALENCE|GMRs were compared to no effect boundaries of 0.67 to 1.50.|Geometric Mean Ratio|0.984|||||TWO_SIDED|90.0|0.851|1.138|||||The numerator represents Arm 3 and the denominator represents Arm 2.|Statistical analysis for Week 2.||1.138|0.851|
72559426|NCT02583048|144648424|EQUIVALENCE|GMRs were compared to no effect boundaries of 0.67 to 1.50.|Geometric Mean Ratio|1.086|||||TWO_SIDED|90.0|0.866|1.361|||||The numerator represents Arm 3 and the denominator represents Arm 2.|Statistical analysis for Week 8.||1.361|0.866|
72559427|NCT02583048|144648424|EQUIVALENCE|GMRs were compared to no effect boundaries of 0.67 to 1.50.|Geometric Mean Ratio|0.927|||||TWO_SIDED|90.0|0.65|1.322|||||The numerator represents Arm 3 and the denominator represents Arm 2.|Statistical analysis for Week 24.||1.322|0.650|
72559428|NCT02155257|144648428|OTHER||Slope|0.19||||0.54|TWO_SIDED|95.0|-0.39|0.76|||Regression, Linear|||Interaction between resting pupil diameter and correlation of cognitive-affective style to pain reporting. Note that this analysis is an INTERACTION between the primary outcome of this measure (pupil diameter) to that of the primary outcome measure of cognitive-affective style.||.76|-.39|0.540
72496307|NCT04426695|144522431|SUPERIORITY|||||||0.0911|||||||MMRM|||Percent Difference vs. Placebo at Day 29||||0.0911
72496308|NCT04426695|144522431|SUPERIORITY|||||||0.0645|||||||MMRM|||Percent Difference vs. Placebo at Day 29||||0.0645
72496309|NCT04426695|144522432|SUPERIORITY|||||||0.0481||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.0481
72442116|NCT03201562|144397319|SUPERIORITY||Odds Ratio (OR)|38.436||||0.0009|TWO_SIDED|90.0|6.262|235.936|||Generalized Estimating Equation (GEE)|GEE model includes 3-line improvement as response variable with sequence, period, treatment as fixed effect, subject within sequence as random effect.||||235.936|6.262|0.0009
72442117|NCT03201562|144397319|SUPERIORITY||Odds Ratio (OR)|36.893||||0.0012|TWO_SIDED|90.0|5.936|229.31|||Generalized Estimating Equation (GEE)|GEE model includes 3-line improvement as response variable with sequence, period, treatment as fixed effect, subject within sequence as random effect.||||229.310|5.936|0.0012
72442118|NCT03201562|144397319|SUPERIORITY||Odds Ratio (OR)|1.042||||0.9298|TWO_SIDED|90.0|0.485|2.239|||Generalized Estimating Equation (GEE)|GEE model includes 3-line improvement as response variable with sequence, period, treatment as fixed effect, subject within sequence as random effect||||2.239|0.485|0.9298
72442119|NCT00393484|144397320|NON_INFERIORITY_OR_EQUIVALENCE|The difference in proportion along with its standard error and 90% confidence interval was computed. If the lower limit of the confidence interval (CI) was great than -10%, noninferiority was established. Provided that noninferiority was established, a test for superiority was planned to check that the lower limit of the 90% CI was greater than zero.|Difference in proportion|25.67||||0.0006|TWO_SIDED|90.0|14.48|36.86||There was no adjustment for the prior test of noninferiority because the test for superiority could succeed only if noninferiority was first established.|Chi-squared|||A sample size of 60 per group provides 80% power for testing superiority of entecavir compared to lamivudine, assuming a response rate of 62% for lamivudine and 83% for entecavir.||36.86|14.48|0.0006
72442120|NCT00393484|144397321|SUPERIORITY_OR_OTHER||Difference|24.55||||0.0003|TWO_SIDED|90.0|14.45|34.66||Treatment comparisons were assessed using the same method used in the primary endpoint.|Chi-squared|||HBV DNA \<10\^3 copies/mL at 24 Weeks||34.66|14.45|0.0003
72442121|NCT00393484|144397321|SUPERIORITY_OR_OTHER||Difference|13.62||||0.0167|TWO_SIDED|90.0|4.85|22.38||Treatment comparisons were assessed using the same method as the primary endpoint.|Chi-squared|||HBV DNA \<10\^4 copies/mL at 24 Weeks||22.38|4.85|0.0167
72442122|NCT00393484|144397321|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.24||||0.4467|TWO_SIDED|90.0|-2.62|11.1|||Chi-squared|||HBV DNA \<10\^5 at 24 Weeks||11.10|-2.62|0.4467
72442123|NCT00393484|144397321|SUPERIORITY_OR_OTHER||Difference|26.12||||0.0002|TWO_SIDED|90.0|15.87|36.36|||Chi-squared|||HBV DNA \<10\^3 copies/mL at 48 Weeks||36.36|15.87|0.0002
72442124|NCT00393484|144397321|SUPERIORITY_OR_OTHER||Difference|20.09||||0.0009|TWO_SIDED|90.0|11.1|29.07|||Chi-squared|||HBV DNA \<10\^4 copies/mL at 48 Weeks||29.07|11.10|0.0009
72496310|NCT04426695|144522432|SUPERIORITY|||||||0.988||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.9880
72622359|NCT00835042|144774579|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|103.0||||||90.0|97.6|108.0|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||108|97.6|
72442125|NCT00393484|144397321|SUPERIORITY_OR_OTHER||Difference|16.96||||0.0029|TWO_SIDED|90.0|8.43|25.5|||Chi-squared|||HBV DNA \<10\^5 at 48 Weeks||25.50|8.43|0.0029
72442126|NCT00393484|144397321|SUPERIORITY_OR_OTHER||Difference|35.27|||<|0.0001|TWO_SIDED|90.0|24.02|46.51|||Chi-squared|||HBV DNA \<10\^3 copies/mL at 96 Weeks||46.51|24.02|<0.0001
72442127|NCT00393484|144397321|SUPERIORITY_OR_OTHER||Difference|29.02|||<|0.0001|TWO_SIDED|90.0|18.07|39.97|||Chi-squared|||HBV DNA \<10\^4 copies/mL at 96 Weeks||39.97|18.07|<0.0001
72442128|NCT00393484|144397321|SUPERIORITY_OR_OTHER||Difference|24.33||||0.0006|TWO_SIDED|90.0|13.71|34.95|||Chi-squared|||HBV DNA \<10\^5 copies/mL at 96 Weeks||34.95|13.71|0.0006
72442129|NCT00393484|144397322|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Treatment comparisons were based on 2-sided t-test for treatment difference (entecavir: lamivudine) estimated from the linear regression model with covariates of treatment and baseline hepatitis B DNA by PCR.|unpaired t-test|||Changes from baseline were based on patients with measurements at both Baseline and Week 24.||||<0.0001
72442130|NCT00393484|144397322|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Treatment comparisons were based on 2-sided t-test for treatment difference (entecavir: lamivudine) estimated from the linear regression model with covariants of treatment and Baseline hepatitis B DNA by PCR.|unpaired t-test|||Changes from Baseline were based on patients with measurements at both Baseline and at Week 48.||||<0.0001
72442131|NCT00393484|144397322|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Treatment comparisons were based on 2-sided t-test for treatment difference (entecavir: lamivudine) estimated from the linear regression model with covariants of treatment and Baseline hepatitis B DNA by PCR.|unpaired t-test|||Changes from Baseline were based on patients with measurements at both Baseline and at 96 Weeks.||||<0.0001
72442132|NCT00393484|144397322|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Treatment comparisons were based on 2-sided t-test for treatment difference (entecavir: lamivudine) estimated from the linear regression model with covariants of treatment and Baseline hepatitis B DNA by PCR.|unpaired t-test|||Changes from Baseline were based on patients with measurements at both Baseline and at Week 144.||||<0.0001
72442133|NCT00393484|144397322|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Treatment comparisons were based on 2-sided t-test for treatment difference (entecavir: lamivudine) estimated from the linear regression model with covariants of treatment and Baseline hepatitis B DNA by PCR.|unpaired t-test|||Changes from Baseline were based on patients with measurements at both Baseline and at Week 192.||||<0.0001
72442134|NCT00393484|144397322|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Treatment comparisons were based on 2-sided t-test for treatment difference (entecavir: lamivudine) estimated from the linear regression model with covariants of treatment and Baseline hepatitis B DNA by PCR.|unpaired t-test|||Changes from Baseline were based on patients with measurements at both Baseline and at Week 240.||||<0.0001
72442135|NCT00393484|144397324|SUPERIORITY_OR_OTHER||Difference|18.97||||0.0278|TWO_SIDED|90.0|5.22|32.73|||Chi-squared||At 24 Weeks|||32.73|5.22|0.0278
72442136|NCT00393484|144397324|SUPERIORITY_OR_OTHER||Difference|26.34||||0.0014|TWO_SIDED|90.0|13.65|39.03|||Chi-squared||At 48 Weeks|||39.03|13.65|0.0014
72442137|NCT00393484|144397324|SUPERIORITY_OR_OTHER||Difference|35.94|||<|0.0001|TWO_SIDED|90.0|23.35|48.52|||Chi-squared||At 96 Weeks|||48.52|23.35|<0.0001
72442138|NCT00393484|144397330|SUPERIORITY_OR_OTHER||Difference|33.71|||<|0.0001|TWO_SIDED|90.0|22.52|44.89|||Chi-squared||At 48 Weeks|||44.89|22.52|<0.0001
72559429|NCT02578641|144648444|SUPERIORITY||Hazard Ratio (HR)|1.19||||0.1942|TWO_SIDED|95.0|0.91|1.56||Between-treatment comparisons were assessed using stratified log-rank test stratified by country and disease stage per randomization stratification.|Log Rank|Log-rank test of Hazards Ration equals 1, using Cox proportional hazards regression.|Hazard ratios were estimated using Cox proportional hazards regression.|||1.56|0.91|0.1942
72559430|NCT01710358|144648449|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|||||||Regression, Logistic|||||||0.001
72559431|NCT01456962|144648501|SUPERIORITY_OR_OTHER|||||||0.6|TWO_SIDED||||||t-test, 2 sided|||||||0.6
72559432|NCT01456962|144648501|SUPERIORITY_OR_OTHER||% change in CD4+:CD8+ T cells ratio|-9.5||||0.4|TWO_SIDED|95.0|-27.3|12.0|||Regression, Linear|Adjusted for treatment group and time on antiretroviral therapy|Change based on a 1 log unit increase in genital:plasma drug ratio|Null hypothesis: Higher genital to plasma antiretroviral drug ratios are not associated with higher cervical CD4+:CD8+ T cell ratios.||12|-27.3|0.4
72559433|NCT02704091|144648541|SUPERIORITY|"The following Null-hypothesis was tested:~H0: λA(t) = λB (t) versus H1: λA(t) ≠ λB (t), where λ(t) represents the hazard at time t, A=diosmectite and B=placebo."|||||=|0.2524|||||||Wilcoxon-Gehan test|||The primary analysis tested the equality of time to recovery between the 2 treatment groups, applying the 2-sided Gehan-Wilcoxon test (α=5%).||||=0.2524
72559434|NCT02704091|144648542|SUPERIORITY||||||=|0.3511|||||||Gehan-Wilcoxon test|||Comparison between the 2 treatment groups for time from diarrhoea onset to recovery, analysed using the Gehan-Wilcoxon test.||||=0.3511
72559435|NCT02704091|144648543|SUPERIORITY||||||=|0.7285|||||||Gehan-Wilcoxon test|||Comparison between the 2 treatment groups for time from diarrhoea onset to first formed stool, analysed using the Gehan-Wilcoxon test.||||=0.7285
72559436|NCT02704091|144648544|SUPERIORITY||||||=|0.1807|||||||Gehan-Wilcoxon test|||Comparison between the 2 treatment groups for time from first study treatment intake to last watery stool, analysed using the Gehan-Wilcoxon test.||||=0.1807
72559437|NCT02704091|144648545|SUPERIORITY||Least Squares (LS) Mean Difference|-0.04||||0.4294|TWO_SIDED|95.0|-0.15|0.07|||ANCOVA|||Comparison between the 2 treatment groups for number of stools for the overall time period, based on an analysis of covariance (ANCOVA) method for repeated measurements. The model included the number of stools 24 hours before randomisation (baseline) as covariate, treatment, time point (12-hour period), the treatment by time point interaction as fixed effects and participant as random effect.||0.07|-0.15|0.4294
72388004|NCT01681472|144284325|SUPERIORITY|||||||0.0263|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of tmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0263
72388005|NCT01681472|144284325|SUPERIORITY|||||||0.0268|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of tmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0268
72388006|NCT01681472|144284325|SUPERIORITY|||||||0.2041|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of tmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.2041
72388007|NCT01681472|144284325|SUPERIORITY|||||||0.0061|||||||Wilcoxon (Mann-Whitney)|||||||0.0061
72388008|NCT01681472|144284326|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of tmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
72388009|NCT01681472|144284326|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of tmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
72388010|NCT01681472|144284326|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of tmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
72388011|NCT01681472|144284326|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of tmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
72388012|NCT01681472|144284326|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of tmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
72388013|NCT01681472|144284326|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of tmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
72388014|NCT01681472|144284327|SUPERIORITY|||||||0.0268|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t1/2 was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0268
72388015|NCT01681472|144284327|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t1/2 was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
72622360|NCT00677040|144774605|EQUIVALENCE|t-test to determine if tissue oxygen measurements are equivalent between treated and nontreated breast|t-test|0.35||||0.5|TWO_SIDED||||||t-test, 2 sided|||||||0.5
72622361|NCT00677040|144774605|OTHER||t-test|0.35||||0.5|TWO_SIDED||||||t-test, 2 sided|||||||.5
72388016|NCT01681472|144284327|SUPERIORITY|||||||0.0227|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t1/2 was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0227
72388017|NCT01681472|144284327|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t1/2 was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
72442139|NCT00393484|144397330|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|46.21|||<|0.0001|TWO_SIDED|90.0|34.8|57.61|||Chi-squared||At 96 Weeks|||57.61|34.80|<0.0001
72388018|NCT01681472|144284327|SUPERIORITY|||||||0.0933|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t1/2 was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0933
72388019|NCT01681472|144284327|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t1/2 was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
72388020|NCT01681472|144284328|SUPERIORITY|||||||0.0177|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t1/2 was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0177
72388021|NCT01681472|144284328|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t1/2 was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
72388022|NCT01681472|144284328|SUPERIORITY|||||||0.0058|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t1/2 was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0058
72388023|NCT01681472|144284328|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t1/2 was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
72388024|NCT01681472|144284328|SUPERIORITY|||||||0.0043|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t1/2 was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0043
72442140|NCT00393484|144397330|SUPERIORITY_OR_OTHER||Difference|33.48||||0.0003|TWO_SIDED|90.0|19.31|47.65|||Chi-squared||At 144 Weeks|||47.65|19.31|0.0003
72388025|NCT01681472|144284328|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t1/2 was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
72388026|NCT01681472|144284329|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t1/2 was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
72388027|NCT01681472|144284329|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t1/2 was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
72388028|NCT01681472|144284329|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t1/2 was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
72388029|NCT01681472|144284329|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t1/2 was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
72388030|NCT01681472|144284329|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t1/2 was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
72388031|NCT01681472|144284329|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t1/2 was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
72388032|NCT01681472|144284330|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t1/2 was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
72388033|NCT01681472|144284330|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t1/2 was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
72388034|NCT01681472|144284330|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t1/2 was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
72388035|NCT01681472|144284330|SUPERIORITY|||||||0.0668|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t1/2 was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0668
72388036|NCT01681472|144284330|SUPERIORITY|||||||0.0502|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t1/2 was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0502
72388037|NCT01681472|144284330|SUPERIORITY|||||||0.0081|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t1/2 was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0081
72388038|NCT01681472|144284331|SUPERIORITY|||||||0.0011|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0011
72442141|NCT00393484|144397330|SUPERIORITY_OR_OTHER||Difference|44.64|||<|0.0001|TWO_SIDED|90.0|31.17|58.11|||Chi-squared||At 192 Weeks|||58.11|31.17|<0.0001
72442142|NCT00393484|144397330|SUPERIORITY_OR_OTHER||Difference|52.23|||<|0.0001|TWO_SIDED|90.0|39.54|64.93|||Chi-squared||At 240 Weeks|||64.93|39.54|<0.0001
72442143|NCT00393484|144397331|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Chi-squared|||Viral rebound at 96 weeks||||<0.0001
72442144|NCT02178098|144397348|SUPERIORITY||Least squares mean difference|-24.24|STANDARD_ERROR_OF_MEAN|3.08|<|0.0001|TWO_SIDED|95.0|-30.33|-18.15|||ANCOVA||The least squares mean difference was calculated as the value for the ETC-1002 180 mg arm minus the value for the placebo arm.|||-18.15|-30.33|<0.0001
72442145|NCT02178098|144397349|SUPERIORITY||Least squares mean difference|-1.64|STANDARD_ERROR_OF_MEAN|1.511||0.2808|TWO_SIDED|95.0|-4.62|1.35|||ANCOVA||The least squares mean difference was calculated as the value for the ETC-1002 180 mg arm minus the value for the placebo arm.|||1.35|-4.62|0.2808
72442146|NCT02178098|144397350|SUPERIORITY||Least squares mean difference|-1.05|STANDARD_ERROR_OF_MEAN|1.111||0.3461|TWO_SIDED|95.0|-3.25|1.15|||ANCOVA||The least squares mean difference was calculated as the value for the ETC-1002 180 mg arm minus the value for the placebo arm.|||1.15|-3.25|0.3461
72442147|NCT02178098|144397351|SUPERIORITY||Least squares mean difference|-2.31|STANDARD_ERROR_OF_MEAN|1.734||0.1852|TWO_SIDED|95.0|-5.74|1.12|||ANCOVA||The least squares mean difference was calculated as the value for the ETC-1002 180 mg arm minus the value for the placebo arm.|||1.12|-5.74|0.1852
72442148|NCT02178098|144397352|SUPERIORITY||Least squares mean difference|-1.45|STANDARD_ERROR_OF_MEAN|1.253||0.2481|TWO_SIDED|95.0|-3.93|1.03|||ANCOVA||The least squares mean difference was calculated as the value for the ETC-1002 180 mg arm minus the value for the placebo arm.|||1.03|-3.93|0.2481
72442149|NCT02178098|144397353|SUPERIORITY||Least squares mean difference|-0.39|STANDARD_ERROR_OF_MEAN|1.684||0.8181|TWO_SIDED|95.0|-3.72|2.94|||ANCOVA||The least squares mean difference was calculated as the value for the ETC-1002 180 mg arm minus the value for the placebo arm.|||2.94|-3.72|0.8181
72559438|NCT02704091|144648546|SUPERIORITY||LS Mean Difference|-0.12||||0.0465|TWO_SIDED|95.0|-0.24|0.0|||ANCOVA|||Comparison between the 2 treatment groups for number of watery stools for the overall time period, based on an ANCOVA method for repeated measurements. The model included the number of watery stools 24 hours before randomisation (baseline) as covariate, treatment, time point (12-hour period), the treatment by time point interaction as fixed effects and participant as random effect.||-0.00|-0.24|0.0465
72559439|NCT02640235|144648572|NON_INFERIORITY|The logistic regression estimates are generated from predicted values of the fitted logistic regression model. If the lower bound of the 95% confidence interval is greater than -10, Celstat is non-inferior to Surgicel. If the lower bound of the 95% confidence interval is greater than 0, Celstat will be declared superior to Surgicel.|Difference in avg predicted proportion|-8.5|||||TWO_SIDED|95.0|-15.6|-1.4|||Regression, Logistic|||||-1.4|-15.6|
72559440|NCT02640235|144648575|OTHER||Difference in avg predicted proportion|4.7|||||TWO_SIDED|95.0|-3.6|13.1|||Regression, Logistic|||||13.1|-3.6|
72559441|NCT02640235|144648576|OTHER||Difference in avg predicted proportion|-6.2|||||TWO_SIDED|95.0|-12.0|-0.5|||Regression, Logistic|||||-0.5|-12|
72559442|NCT02640235|144648577|OTHER||Difference in avg predicted proportion|-0.7|||||TWO_SIDED|95.0|-5.7|4.3|||Regression, Logistic|||||4.3|-5.7|
72559443|NCT02640235|144648578|OTHER||Difference in avg predicted proportion|0.2|||||TWO_SIDED|95.0|-3.9|4.4|||Regression, Logistic|||||4.4|-3.9|
72622362|NCT05524948|144774636|OTHER||Adjusted Mean Difference|-1.3|STANDARD_ERROR_OF_MEAN|0.206|<|0.0001|TWO_SIDED|95.0|-1.71|-0.9|||ANCOVA|Analysis was performed using ANCOVA model with study product and gender as a factor and Baseline overall breath organoleptic score as a covariate.|Adjusted mean difference was calculated as experimental dentifrice minus reference dentifrice.|||-0.90|-1.71|<0.0001
72442150|NCT02178098|144397354|SUPERIORITY||Least squares mean difference|0.19|STANDARD_ERROR_OF_MEAN|1.274||0.8817|TWO_SIDED|95.0|-2.33|2.71|||ANCOVA||The least squares mean difference was calculated as the value for the ETC-1002 180 mg arm minus the value for the placebo arm.|||2.71|-2.33|0.8817
72442151|NCT02178098|144397355|SUPERIORITY||Least squares mean difference|1.53|STANDARD_ERROR_OF_MEAN|1.829||0.404|TWO_SIDED|95.0|-2.09|5.15|||ANCOVA||The least squares mean difference was calculated as the value for the ETC-1002 180 mg arm minus the value for the placebo arm.|||5.15|-2.09|0.4040
72442152|NCT02178098|144397356|SUPERIORITY||Least squares mean difference|0.79|STANDARD_ERROR_OF_MEAN|1.178||0.5061|TWO_SIDED|95.0|-1.54|3.11|||ANCOVA||The least squares mean difference was calculated as the value for the ETC-1002 180 mg arm minus the value for the placebo arm.|||3.11|-1.54|0.5061
72442153|NCT02178098|144397357|SUPERIORITY||Median Difference (Final Values)|-43.64|||<|0.0001|TWO_SIDED|95.0|-62.8|-25.21|||Wilcoxon Rank-Sum Test||The 95% confidence interval (CI) was calculated using Hodges-Lehmann analysis.|||-25.21|-62.80|<0.0001
72442154|NCT02178098|144397358|SUPERIORITY||Least squares mean difference|-16.67|STANDARD_ERROR_OF_MEAN|2.006|<|0.0001|TWO_SIDED|95.0|-20.63|-12.7|||ANCOVA||The least squares mean difference was calculated as the value for the ETC-1002 180 mg arm minus the value for the placebo arm.|||-12.70|-20.63|<0.0001
72442155|NCT02178098|144397359|SUPERIORITY||Least squares mean difference|-18.9|STANDARD_ERROR_OF_MEAN|2.624|<|0.0001|TWO_SIDED|95.0|-24.09|-13.71|||ANCOVA||The least squares mean difference was calculated as the value for the ETC-1002 180 mg arm minus the value for the placebo arm.|||-13.71|-24.09|<0.0001
72442156|NCT02178098|144397360|SUPERIORITY||Least squares mean difference|-18.69|STANDARD_ERROR_OF_MEAN|2.49|<|0.0001|TWO_SIDED|95.0|-23.62|-13.77|||ANCOVA||The least squares mean difference was calculated as the value for the ETC-1002 180 mg arm minus the value for the placebo arm.|||-13.77|-23.62|<0.0001
72559444|NCT01370863|144648580|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Mean|-1.452||||0.869|TWO_SIDED|95.0|-19.054|16.149|||ANCOVA|||||16.149|-19.054|0.869
72559445|NCT01370863|144648581|SUPERIORITY_OR_OTHER_LEGACY||Diference in LS means|0.264||||0.487|TWO_SIDED|95.0|-0.495|1.024|||ANCOVA|||||1.024|-0.495|0.487
72559446|NCT01370863|144648582|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS means|-0.087||||0.637|TWO_SIDED|95.0|-0.501|0.326|||ANCOVA|||||0.326|-0.501|0.637
72559447|NCT00834561|144648604|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|104.14||||||90.0|99.99|108.47|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||108.47|99.99|
72559448|NCT00834561|144648605|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|104.07||||||90.0|101.33|106.89|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||106.89|101.33|
72559449|NCT00834561|144648606|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|103.68||||||90.0|101.42|106.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||106.00|101.42|
72559450|NCT01046084|144648644|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|103.0|||||TWO_SIDED|90.0|86.5|123.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||123|86.5|
72559451|NCT01046084|144648645|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|104.0|||||TWO_SIDED|90.0|89.3|120.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||120|89.3|
72559452|NCT01046084|144648646|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|107.0|||||TWO_SIDED|90.0|92.5|123.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||123|92.5|
72559453|NCT01390948|144648786|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.44||||0.1292|TWO_SIDED|95.0|0.9|2.3|||Log Rank|||||2.30|0.90|0.1292
72559454|NCT00556673|144648813|SUPERIORITY_OR_OTHER||LS Mean Difference|0.39|||<|0.0001|TWO_SIDED|90.0|0.28|0.51||"Linear mixed effect model fitting treatment, sequence and period as fixed factors, patient within sequence as a random factor and pre-dose FEV1 as covariate.~A significance level of 5% was used to determine statistical significance."|1-sided|||The primary hypothesis tested was that the change from period baseline of trough FEV1 for placebo and indacaterol/mometasone was equal. The one-sided alternative was that the increase from period baseline of trough FEV1 for indacaterol/mometasone was higher than for placebo.||0.51|0.28|< 0.0001
72559455|NCT01131260|144648831|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.31||||0.2|TWO_SIDED|95.0|0.87|1.98|||Chi-squared|||Analysis on primary composite outcome as a whole.||1.98|0.87|0.20
72559456|NCT01131260|144648833|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|3.02||||0.37|TWO_SIDED|95.0|0.31|29.1|||Fisher Exact|||||29.1|0.31|0.37
72559457|NCT01131260|144648834|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|2.86||||0.02|TWO_SIDED|95.0|1.13|7.24|||Chi-squared|||||7.24|1.13|0.02
72559458|NCT01131260|144648835|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.76||||1|TWO_SIDED|95.0|0.17|3.38|||Fisher Exact|||||3.38|0.17|1.0
72559459|NCT01131260|144648836|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.37||||0.13|TWO_SIDED|95.0|0.1|1.41|||Chi-squared|||||1.41|0.10|0.13
72442157|NCT02178098|144397361|SUPERIORITY||Median Difference (Final Values)|5.25||||0.3689|TWO_SIDED|95.0|-6.78|16.42|||Wilcoxon Rank-Sum Test||The 95% CI was calculated using Hodges-Lehmann analysis.|||16.42|-6.78|0.3689
72442158|NCT02178098|144397362|SUPERIORITY||Least squares mean difference|-8.18|STANDARD_ERROR_OF_MEAN|2.319||0.0006|TWO_SIDED|95.0|-12.76|-3.59|||ANCOVA||The least squares mean difference was calculated as the value for the ETC-1002 180 mg arm minus the value for the placebo arm.|||-3.59|-12.76|0.0006
72559460|NCT01131260|144648837|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.57||||0.07|TWO_SIDED|95.0|0.97|2.54|||Chi-squared|||||2.54|0.97|0.07
72622363|NCT05524948|144774637|OTHER||Adjusted Mean Difference|-569.64|STANDARD_ERROR_OF_MEAN|97.479|<|0.0001|TWO_SIDED|95.0|-763.11|-376.17|||ANCOVA|Analysis was performed using ANCOVA model with study product and gender as a factor and baseline concentration as a covariate.||||-376.17|-763.11|<0.0001
72442159|NCT02178098|144397363|SUPERIORITY||Median Difference (Final Values)|7.6||||0.3093|TWO_SIDED|95.0|-8.21|24.02|||Wilcoxon Rank-Sum Test||The 95% CI was calculated using Hodges-Lehmann analysis.|||24.02|-8.21|0.3093
72442160|NCT01553058|144397377|OTHER|Difference of Differences||||||0.795|||||||Regression, Linear|||||||0.795
72442161|NCT01553058|144397377|OTHER|Difference of differences||||||0.647|||||||Regression, Linear|||||||0.647
72442162|NCT01553058|144397378|OTHER|Difference of differences||||||0.386|||||||Regression, Linear|||||||0.386
72442163|NCT01553058|144397378|OTHER|Difference of Differences||||||0.28|||||||Regression, Linear|||||||0.280
72442164|NCT01553058|144397385|OTHER|Difference of Differences||||||0.357|||||||Regression, Linear|||||||0.357
72442165|NCT01553058|144397385|OTHER|Difference of Differences||||||0.496|||||||Regression, Linear|||||||0.496
72559461|NCT01131260|144648838|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.81||||1|TWO_SIDED|95.0|0.22|3.0|||Fisher Exact|||||3.00|0.22|1.0
72559462|NCT01131260|144648839|SUPERIORITY_OR_OTHER|||||||0.17|||||||Chi-squared|||||||.17
72559463|NCT01131260|144648840|SUPERIORITY_OR_OTHER|||||||0.45||||||The p value was calculated based on the entire study cohort.|Chi-squared|||||||0.45
72559464|NCT01131260|144648842|SUPERIORITY_OR_OTHER|||||||0.32|||||||Wilcoxon (Mann-Whitney)|||||||.32
72559465|NCT01131260|144648843|SUPERIORITY_OR_OTHER|||||||0.35|||||||Chi-squared|||||||0.35
72559466|NCT01131260|144648844|SUPERIORITY_OR_OTHER|||||||0.4|||||||Chi-squared|||||||0.40
72559467|NCT01131260|144648845|SUPERIORITY_OR_OTHER|||||||0.59|||||||Chi-squared|||||||0.59
72559468|NCT01131260|144648846|SUPERIORITY_OR_OTHER|||||||0.19|||||||Chi-squared|||||||.19
72559469|NCT01131260|144648847|SUPERIORITY_OR_OTHER|||||||0.77|||||||Wilcoxon (Mann-Whitney)|||||||0.77
72559470|NCT01131260|144648848|SUPERIORITY_OR_OTHER|||||||0.28|||||||Chi-squared|||||||0.28
72559471|NCT01131260|144648849|SUPERIORITY_OR_OTHER|||||||0.54|||||||Wilcoxon (Mann-Whitney)|||||||0.54
72559472|NCT01131260|144648850|SUPERIORITY_OR_OTHER|||||||0.98|||||||Chi-squared|||||||0.98
72559473|NCT01131260|144648851|SUPERIORITY_OR_OTHER|||||||0.05|||||||Chi-squared|||||||.05
72559474|NCT03555695|144648857|SUPERIORITY||Mean Difference (Final Values)|0.6||||0.12|TWO_SIDED||||||t-test, 2 sided|||||||0.12
72442166|NCT01553058|144397386|OTHER|Difference of Differences||||||0.897|||||||Regression, Linear|||||||0.897
72442167|NCT01553058|144397386|OTHER|Difference of differences||||||0.467|||||||Regression, Linear|||||||0.467
72442168|NCT01553058|144397387|OTHER|Difference of differences||||||0.089|||||||Regression, Linear|||||||0.089
72442169|NCT01553058|144397387|OTHER|Difference of differences||||||0.03|||||||Regression, Linear|||||||0.030
72442170|NCT01553058|144397388|OTHER|Difference of differences||||||0.934|||||||Regression, Linear|||||||0.934
72442171|NCT01553058|144397388|OTHER|Difference of differences||||||0.679|||||||Regression, Linear|||||||0.679
72442172|NCT01553058|144397389|OTHER|Difference of differences||||||0.672|||||||Regression, Linear|||||||0.672
72442173|NCT01553058|144397389|OTHER|Difference of differences||||||0.655|||||||Regression, Linear|||||||0.655
72442174|NCT01553058|144397390|OTHER|Difference of differences||||||0.504|||||||Regression, Linear|||||||0.504
72496311|NCT04426695|144522432|SUPERIORITY|||||||0.2498||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.2498
72442175|NCT01553058|144397390|OTHER|Difference of differences||||||0.695|||||||Regression, Linear|||||||0.695
72442176|NCT01553058|144397391|OTHER|Difference of differences||||||0.002|||||||Regression, Linear|||||||0.002
72442177|NCT01553058|144397391|OTHER|Difference of differences||||||0.009|||||||Regression, Linear|||||||0.009
72442178|NCT01553058|144397392|OTHER|Difference of Differences|||||<|0.001|||||||Regression, Linear|||||||<0.001
72442179|NCT01553058|144397392|OTHER|Difference of differences||||||0.065|||||||Regression, Linear|||||||0.065
72442180|NCT01553058|144397393|OTHER|Difference of differences||||||0.007|||||||Regression, Linear|||||||0.007
72442181|NCT01553058|144397393|OTHER|Difference of differences||||||0.019|||||||Regression, Linear|||||||0.019
72442182|NCT01553058|144397394|OTHER|Difference of differences||||||0.006|||||||Regression, Linear|||||||0.006
72442183|NCT01553058|144397394|OTHER|Difference of differences||||||0.628|||||||Regression, Linear|||||||0.628
72442184|NCT03087708|144397486|OTHER||||||<|1|||||||Fisher Exact|||Comparison of Hematologic 3+ vs Hematologic \<3||||<1
72442185|NCT03087708|144397486|OTHER||||||<|0.7051|||||||Fisher Exact|||Comparison of Non-Hematologic 3+ vs Non-Hematologic \<3||||<0.7051
72442186|NCT03087708|144397486|OTHER||||||<|0.6546|||||||Fisher Exact|||Comparison of Hematologic 3+ vs Hematologic \<3||||<0.6546
72442187|NCT03087708|144397486|OTHER||||||<|0.7051|||||||Fisher Exact|||Comparison of Non-Hematologic 3+ vs Non-Hematologic \<3||||<0.7051
72442188|NCT03087708|144397486|OTHER||||||<|0.2262|||||||Fisher Exact|||Comparison of Non-Hematologic 3+ vs Non-Hematologic \<3||||<0.2262
72442189|NCT03087708|144397486|OTHER||||||<|1|||||||Fisher Exact|||Comparison of Hematologic 3+ vs Hematologic \<3||||<1
72442190|NCT03087708|144397486|OTHER||||||<|1|||||||Fisher Exact|||Comparison of Non-Hematologic 3+ vs Non-Hematologic \<3||||<1
72442191|NCT03087708|144397490|OTHER||||||<|0.68182|||||||Fisher Exact|||||||<0.68182
72442192|NCT03087708|144397490|OTHER||||||<|0.1091|||||||Fisher Exact|||||||<0.1091
72442193|NCT03087708|144397491|OTHER||||||<|1|||||||Wilcoxon (Mann-Whitney)|||||||<1.0
72442194|NCT03087708|144397491|OTHER||||||<|0.3339|||||||Wilcoxon (Mann-Whitney)|||||||<0.3339
72442195|NCT03087708|144397492|OTHER||||||<|0.593|||||||Wilcoxon (Mann-Whitney)|||||||<0.5930
72442196|NCT03087708|144397492|OTHER||||||<|0.3105|||||||Wilcoxon (Mann-Whitney)|||||||<0.3105
72442197|NCT03087708|144397493|OTHER|||||||0.6024|||||||Wilcoxon (Mann-Whitney)|||Average Pain Scores at Baseline||||0.6024
72442198|NCT03087708|144397493|OTHER||||||<|0.3116|||||||Wilcoxon (Mann-Whitney)|||Average Pain Scores at Baseline||||<0.3116
72442199|NCT03087708|144397493|OTHER||||||<|0.7712|||||||Wilcoxon (Mann-Whitney)|||Average Pain Scores at 6 Months||||<0.7712
72442200|NCT03087708|144397493|OTHER||||||<|1|||||||Wilcoxon (Mann-Whitney)|||Average Pain Scores at 6 Months||||<1.0
72442201|NCT03087708|144397494|OTHER||||||<|1|||||||Fisher Exact|||Analgesic Use at 6 Months||||<1.0000
72442202|NCT03087708|144397494|OTHER||||||<|0.5758|||||||Fisher Exact|||Analgesic Use at 6 Months||||<0.5758
72442203|NCT03087708|144397494|OTHER||||||<|1|||||||Fisher Exact|||Analgesic use at Baseline||||<1.0000
72442204|NCT03087708|144397494|OTHER|||||||0.593|||||||Fisher Exact|||Analgesic use at Baseline||||0.5930
72442205|NCT01303445|144397499|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was established if the 90% confidence interval of the mean ratio fell within the 80 to 125% target range.|Percent Mean Ratio|92.03||||||90.0|86.95|97.4||||||Comparison of Aggrenox + Omeprazole following Omeprazole versus Aggrenox alone||97.40|86.95|
72442206|NCT01303445|144397499|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was established if the 90% confidence interval of the mean ratio fell within the 80 to 125% target range.|Percent Mean Ratio|92.3||||||90.0|87.76|97.08||||||Comparison of Aggrenox + Omeprazole following Aggrenox versus Aggrenox alone||97.08|87.76|
72442207|NCT01303445|144397500|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was established if the 90% confidence interval of the mean ratio fell within the 80 to 125% target range.|Percent Mean Ratio|96.38||||||90.0|90.96|102.13||||||Comparison of Aggrenox + Omeprazole following Omeprazole versus Aggrenox alone||102.13|90.96|
72442208|NCT01303445|144397500|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was established if the 90% confidence interval of the mean ratio fell within the 80 to 125% target range.|Percent Mean Ratio|97.03||||||95.0|93.26|100.95||||||Comparison of Aggrenox + Omeprazole following Aggrenox versus Aggrenox alone||100.95|93.26|
72442209|NCT01303445|144397501|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was established if the 90% confidence interval of the mean ratio fell within the 80 to 125% target range.|Percent Mean Ratio|99.02||||||90.0|98.32|99.72||||||Comparison of Aggrenox + Omeprazole following Omeprazole versus Aggrenox alone||99.72|98.32|
72442210|NCT01303445|144397501|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was established if the 90% confidence interval of the mean ratio fell within the 80 to 125% target range.|Percent Mean Ratio|98.42||||||90.0|97.66|99.18||||||Comparison of Aggrenox + Omeprazole following Aggrenox versus Aggrenox alone||99.18|97.66|
72496312|NCT04426695|144522432|SUPERIORITY|||||||1||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||1.0000
72559475|NCT03544216|144648868|OTHER||||||<|0.001||||||"Results of post-hoc analyses comparing scores of each lens type to one another:~Habitual lens and multifocal contact lens: p \<0.001 Habitual lens and single vision lens: p \<0.001 Multifocal lens and single vision lens: p = 0.08"|Generalized linear models|||Generalized linear models (controlling for repeated measures) of crossover analyses was run to compare mean CLDEQ-8 scores with habitual, multifocal, and single vision contact lenses (controlling for order)||||<0.001
72559476|NCT03544216|144648868|OTHER|||||||0.5||||||Analysis controlled for order, visit, and repeated measures.|Generalized linear model|||A generalized linear model was run to determine if there was an interaction between lens type (single vision or multifocal) and refractive error (continuous, mean binocular spherical equivalent)||||0.5
72559477|NCT03544216|144648868|OTHER|||||||0.7||||||Analysis controlled for order, visit, and repeated measures.|Generalized linear model|||A generalized linear model was run to determine if there was an interaction between magnitude in accommodative lag (measured in diopters with a 2 diopter visual target) and lens type (single vision or multifocal)||||0.7
72559478|NCT03544216|144648868|OTHER|||||||0.3||||||Analysis controlled for order, visit, and repeated measures.|Generalized linear model|||A generalized linear model was run to determine if there was an interaction between lens type (single vision or multifocal) and age (continuous, measured in self-reported years)||||0.3
72559479|NCT03544216|144648868|OTHER|||||||0.047||||||Analysis controlled for order, visit, and repeated measures|Generalized linear model|||A generalized linear model was run to determine if there was an interaction between lens type (single vision or multifocal) and age (measured categorically as 30 to \<35 years old and 35 to 40 years old, by self report)|"Post-Hoc Testing comparing CLDEQ-8 scores and the interaction between lens type and age group (denoted by lens type\*age group) produced the following results:~p = 0.01 for MF\*\<35 age group compared to Single Vision (SV)\*\<35 age group p = 0.07 for MF\*\<35 age group compared to MF\*\>35 age group p \> 0.05 for MF\*\<35 age group compared to Single Vision (SV)\*\>35 age group p \> 0.05 for SV\*\<35 age group compared to SV\*\>35 age group p \>0.05 for SV\*\<35 age group compared to MF\*\>35 age group p \> 0.05 for MF\*\>35 age group compared to SV\*\>25 age group"|||0.047
72559480|NCT02286466|144648889|SUPERIORITY||Mean Difference (Final Values)|1.14|STANDARD_ERROR_OF_MEAN|1.38||0.412|TWO_SIDED|95.0|-1.6|3.87||a priori threshold p\<0.05|ANCOVA|Adjusted for baseline values of criterion outcomes and psychotropic medication use||Analysis comparing the change in anxiety symptoms (HAM-A) from baseline to post-assessment between groups adjusting for baseline values of criterion outcome and psychotropic medication use.||3.87|-1.60|0.412
72559481|NCT02286466|144648890|SUPERIORITY||Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|2.51||0.997|TWO_SIDED|95.0|-4.99|4.96||a priori threshold p\<0.05|ANCOVA|Adjusted for baseline values of criterion outcome and psychotropic medication use||Analysis comparing the change in quality of life (FACT-G) from baseline to post-assessment between groups adjusting for baseline values of criterion outcome and psychotropic medication use||4.96|-4.99|0.997
72559482|NCT02286466|144648891|SUPERIORITY||Mean Difference (Final Values)|0.78|STANDARD_ERROR_OF_MEAN|0.63||0.215|TWO_SIDED|95.0|-0.46|2.02||a priori threshold p\<0.05|ANCOVA|Adjusted for baseline values of criterion outcome and psychotropic medication use||Analysis comparing the change in self-report anxiety symptoms on the HADS-Anxiety Subscale from baseline to post-assessment between groups adjusting for baseline values of criterion outcome and psychotropic medication use.||2.02|-0.46|0.215
72559483|NCT02286466|144648891|SUPERIORITY||Mean Difference (Final Values)|0.48|STANDARD_ERROR_OF_MEAN|0.55||0.379|TWO_SIDED|95.0|-0.6|1.57||a priori threshold p\<0.05|ANCOVA|Adjusted for baseline values of criterion outcome and psychotropic medication use||Analysis comparing the change in self-report depression symptoms on the HADS-Depression Subscale from baseline to post-assessment between groups adjusting for baseline values of criterion outcome and psychotropic medication use.||1.57|-0.60|0.379
72559484|NCT02286466|144648892|SUPERIORITY||Mean Difference (Final Values)|0.15|STANDARD_ERROR_OF_MEAN|0.81||0.852|TWO_SIDED|95.0|-1.45|1.75||a priori threshold p\<0.05|ANCOVA|Adjusted for baseline values of criterion outcome and psychotropic medication use||Analysis comparing the change in depression symptoms on the PHQ-9 from baseline to post-assessment between groups adjusting for baseline values of criterion outcome and psychotropic medication use.||1.75|-1.45|0.852
72388039|NCT01681472|144284331|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
72388040|NCT01681472|144284331|SUPERIORITY|||||||0.0015|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0015
72388041|NCT01681472|144284331|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
72388042|NCT01681472|144284331|SUPERIORITY|||||||0.6691|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.6691
72559485|NCT00835081|144648893|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model containing factors for sequence of products, subjects within sequence, periods, and products was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|103.0||||||90.0|95.9|110.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%|||110|95.9|
72559486|NCT00835081|144648894|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model containing factors for sequence of products, subjects within sequence, periods, and products was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|100.0||||||90.0|97.5|103.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%|||103|97.5|
72559487|NCT00835081|144648895|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model containing factors for sequence of products, subjects within sequence, periods, and products was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|99.8||||||90.0|97.4|102.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%|||102|97.4|
72559488|NCT00421304|144648896|SUPERIORITY|||||||0.218|||||||Wilcoxon's rank-sum test|||||||0.218
72559489|NCT00421304|144648896|SUPERIORITY|||||||0.643|||||||Wilcoxon's rank-sum test|||||||0.643
72442211|NCT01303445|144397502|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was established if the 90% confidence interval of the mean ratio fell within the 80 to 125% target range.|Percent Mean Ratio|105.55||||||90.0|97.09|114.74||||||Comparison of Aggrenox + Omeprazole following Omeprazole versus Aggrenox alone||114.74|97.09|
72442212|NCT01303445|144397502|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was established if the 90% confidence interval of the mean ratio fell within the 80 to 125% target range.|Percent Mean Ratio|106.09||||||90.0|98.64|114.09||||||Comparison of Aggrenox + Omeprazole following Aggrenox versus Aggrenox alone||114.09|98.64|
72442213|NCT01303445|144397503|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was established if the 90% confidence interval of the mean ratio fell within the 80 to 125% target range.|Percent Mean Ratio|99.38||||||90.0|98.8|99.95||||||Comparison of Aggrenox + Omeprazole following Omeprazole versus Aggrenox alone||99.95|98.80|
72442214|NCT01303445|144397503|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was established if the 90% confidence interval of the mean ratio fell within the 80 to 125% target range.|Percent Mean Ratio|99.02||||||90.0|98.46|99.59||||||Comparison of Aggrenox + Omeprazole following Aggrenox versus Aggrenox alone||99.59|98.46|
72442215|NCT02576509|144397508|SUPERIORITY||Hazard Ratio (HR)|0.85||||0.0752|TWO_SIDED|95.0|0.71|1.02||A priori threshold for statistical significance is 0.0419|Log Rank|Log-rank Test stratified by the stratification factors as entered into the IVRS|Nivolumab over Sorafenib; Stratified Cox proportional hazard model||95.81% CI ADJUSTED FOR MULTIPLICITY: (0.72 to 1.02)|1.02|0.71|0.0752
72442216|NCT02576509|144397509|OTHER|no test was performed due to OS p-value result above the prior threshold|Difference of ORRs|8.3|||||TWO_SIDED|95.0|3.9|12.7|||||Estimate of (Nivolumab - Sorafenib) is based on CMH method of weighting, stratified by stratification factors|||12.7|3.9|
72442217|NCT02576509|144397509|OTHER|no test was performed due to OS p-value result above the prior threshold|Odds Ratio (OR)|2.41|||||TWO_SIDED|95.0|1.48|3.92|||||Nivolumab over Sorafenib; Mantel-Haenszel estimator|||3.92|1.48|
72442218|NCT02576509|144397510|OTHER|no test was performed due to OS p-value result above the prior threshold|Hazard Ratio (HR)|0.93|||||TWO_SIDED|95.0|0.79|1.1|||||Nivolumab over Sorafenib; Stratified Cox proportional hazard model|||1.10|0.79|
72442219|NCT02576509|144397511|OTHER|PD-L1 \>= 1%, OS; no test was performed|Hazard Ratio (HR)|0.8|||||TWO_SIDED|95.0|0.54|1.19|||||Nivolumab over Sorafenib|||1.19|0.54|
72442220|NCT02576509|144397511|OTHER|PD-L1 \>=1%, PFS; no test was performed|Hazard Ratio (HR)|0.71|||||TWO_SIDED|95.0|0.48|1.03|||||Nivolumab over Sorafenib|||1.03|0.48|
72442221|NCT02576509|144397511|OTHER|PD-L1 \<1%, OS; no test was performed|Hazard Ratio (HR)|0.84|||||TWO_SIDED|95.0|0.69|1.02|||||Nivolumab over Sorafenib|||1.02|0.69|
72442222|NCT02576509|144397511|OTHER|PD-L1 \<1%, PFS; no test was performed|Hazard Ratio (HR)|0.98|||||TWO_SIDED|95.0|0.81|1.17|||||Nivolumab over Sorafenib|||1.17|0.81|
72442223|NCT02576509|144397511|OTHER|without PD-L1 quantifiable, OS; no test was performed|Hazard Ratio (HR)|1.26|||||TWO_SIDED|95.0|0.34|4.74|||||Nivolumab over Sorafenib|||4.74|0.34|
72442224|NCT02576509|144397511|OTHER|without PD-L1 quantifiable, PFS; no test was performed|Hazard Ratio (HR)|0.98|||||TWO_SIDED|95.0|0.27|3.52|||||Nivolumab over Sorafenib|||3.52|0.27|
72442225|NCT02576509|144397512|OTHER|PD-L1 \>=1%, ORR; no test was performed|Odds Ratio (OR)|3.79|||||TWO_SIDED|95.0|1.41|10.17|||||Odds ratio (Nivolumab over Sorafenib) and associated unstratified 95% exact CI.|||10.17|1.41|
72442226|NCT02576509|144397512|OTHER|PD-L1 \<1%, ORR; no test was performed|Odds Ratio (OR)|1.95|||||TWO_SIDED|95.0|1.1|3.45|||||Odds ratio (Nivolumab over Sorafenib) and associated unstratified 95% exact CI|||3.45|1.10|
72442227|NCT06546657|144397527|OTHER||Mean Difference (Final Values)|1.74||||0.14|TWO_SIDED|95.0|-0.6|4.0||a priori threshold for statistical significance \<0.05|Linear Mixed Model|||Medium GI vs low GI breakfast meals||4.0|-0.6|0.14
72442228|NCT06546657|144397527|OTHER||Mean Difference (Final Values)|4.4||||0.01|TWO_SIDED|95.0|1.2|7.5|||Linear Mixed Model|||Medium vs high GI breakfast meals||7.5|1.2|0.01
72442229|NCT06546657|144397527|OTHER||Mean Difference (Final Values)|-2.63||||0.12|TWO_SIDED|95.0|-6.0|0.7||a priori threshold for statistical significance \<0.05|Linear Mixed Model|||High GI vs low GI breakfast meals||0.7|-6.0|0.12
72442230|NCT06546657|144397528|OTHER||Mean Difference (Final Values)|0.1815||||0.65|TWO_SIDED||||||Linear Mixed Model|||High GI breakfast meals vs low and medium GI breakfast meals||||0.65
72442231|NCT06546657|144397529|OTHER||Mean Difference (Final Values)|0.431||||0.25|TWO_SIDED|95.0|-0.3|1.2|||Linear Mixed Model|||High glycaemic load breakfast meals vs low and medium glycaemic load meals||1.2|-0.3|0.25
72559490|NCT00421304|144648896|SUPERIORITY|||||||0.677|||||||Wilcoxon's rank-sum test|||||||0.677
72559491|NCT00421304|144648897|SUPERIORITY|||||||0.257|||||||Wilcoxon's rank-sum test|||||||0.257
72559492|NCT00421304|144648897|SUPERIORITY|||||||0.726|||||||Wilcoxon's rank-sum test|||||||0.726
72559493|NCT00421304|144648897|SUPERIORITY|||||||0.551|||||||Wilcoxon's rank-sum test|||||||0.551
72559494|NCT00421304|144648898|SUPERIORITY|||||||0.591|||||||Wilcoxon's rank-sum test|||||||0.591
72559495|NCT00421304|144648898|SUPERIORITY|||||||0.393|||||||Wilcoxon's rank-sum test|||||||0.393
72559496|NCT00421304|144648898|SUPERIORITY|||||||0.586|||||||Wilcoxon's rank-sum test|||||||0.586
72559497|NCT00421304|144648899|SUPERIORITY|||||||0.894|||||||Wilcoxon's rank-sum test|||||||0.894
72559498|NCT00421304|144648899|SUPERIORITY|||||||0.674|||||||Wilcoxon's rank-sum test|||||||0.674
72559499|NCT00421304|144648899|SUPERIORITY|||||||0.636|||||||Wilcoxon's rank-sum test|||||||0.636
72559500|NCT00421304|144648900|SUPERIORITY|||||||0.397|||||||Wilcoxon's rank-sum test|||||||0.397
72559501|NCT00421304|144648900|SUPERIORITY|||||||0.238|||||||Wilcoxon's rank-sum test|||||||0.238
72559502|NCT00421304|144648900|SUPERIORITY|||||||0.461|||||||Wilcoxon's rank-sum test|||||||0.461
72559503|NCT00421304|144648901|SUPERIORITY|||||||0.322|||||||Wilcoxon's rank-sum test|||||||0.322
72442232|NCT06546657|144397530|OTHER||Mean Difference (Final Values)|22.0||||0.04|TWO_SIDED|95.0|0.6|44.0|||Linear Mixed Model|||High glycaemic load breakfast meals vs low and medium glycaemic load meals||44|0.6|0.04
72442233|NCT06546657|144397531|OTHER||Mean Difference (Final Values)|1.3||||0.01|TWO_SIDED|95.0|0.4|2.1|||Linear Mixed Model|||Breakfast cereals meals vs added protein meals||2.1|0.4|0.01
72442234|NCT06546657|144397533|OTHER|Comparison of diurnal and nocturnal glucose variability (CV%)|Mean Difference (Final Values)|1.7|||<|0.001|TWO_SIDED||||||t-test, 2 sided|||||||<0.001
72442235|NCT03725722|144397541|SUPERIORITY||||||<|0.0001||||||"P-values were adjusted for multiple comparisons. Models with adjusted p-value of \<0.025 were stat. sign. diff. from a flat dose-response model.~Model selected: Sigmoid Emax model"|Multiple contrast test|||The primary endpoint was evaluated by determining if there was a dose-response relationship between the change from baseline to Week 8 in EASI score and the dose administered using the Multiple Comparison Procedure - Modelling (MCP-Mod) methodology. Several candidate parametric models were assumed and multiple comparison techniques were used to choose the model(s) likely to present the true underlying dose-response curve.||||<0.0001
72442236|NCT03725722|144397541|SUPERIORITY||Mean Difference (Net)|-3.1|||<|0.01|TWO_SIDED|95.0|-5.0|-1.3||The stat. test was not controlled for multiplicity. Data at visits following premature discont. of IMP or initiation of rescue med. were excluded from the analysis. Likewise for missing data due to COVID-19 pandemic.|Mixed Models Analysis|||"Least square (LS) means were calculated using a mixed model response model (MMRM) on post-baseline responses up to Week 8 with an unstructured covariance matrix, Kenward-Roger approximation to estimate denominator degrees of freedom and the mean modelled as follows:~Change from baseline in EASI = treatment x visit + baseline EASI x visit + region + baseline vIGA-AD.~The primary comparison between each active delgocitinib dose and delgocitinib cream vehicle was at Week 8."||-1.3|-5.0|<0.01
72442237|NCT03725722|144397541|SUPERIORITY||Mean Difference (Net)|-3.0|||<|0.05|TWO_SIDED|95.0|-4.8|-1.2||The stat. test was not controlled for multiplicity. Data at visits following premature discont. of IMP or initiation of rescue med. were excluded from the analysis. Likewise for missing data due to COVID-19 pandemic.|Mixed Models Analysis|||"Least square (LS) means were calculated using a mixed model response model (MMRM) on post-baseline responses up to Week 8 with an unstructured covariance matrix, Kenward-Roger approximation to estimate denominator degrees of freedom and the mean modelled as follows:~Change from baseline in EASI = treatment x visit + baseline EASI x visit + region + baseline vIGA-AD.~The primary comparison between each active delgocitinib dose and delgocitinib cream vehicle was at Week 8."||-1.2|-4.8|<0.05
72442238|NCT03725722|144397541|SUPERIORITY||Mean Difference (Net)|-4.0|||<|0.0001|TWO_SIDED|95.0|-5.8|-2.1||The stat. test was not controlled for multiplicity. Data at visits following premature discont. of IMP or initiation of rescue med. were excluded from the analysis. Likewise for missing data due to COVID-19 pandemic.|Mixed Models Analysis|||"Least square (LS) means were calculated using a mixed model response model (MMRM) on post-baseline responses up to Week 8 with an unstructured covariance matrix, Kenward-Roger approximation to estimate denominator degrees of freedom and the mean modelled as follows:~Change from baseline in EASI = treatment x visit + baseline EASI x visit + region + baseline vIGA-AD.~The primary comparison between each active delgocitinib dose and delgocitinib cream vehicle was at Week 8."||-2.1|-5.8|<0.0001
72442239|NCT03725722|144397541|SUPERIORITY||Median Difference (Net)|-5.7|||<|0.0001|TWO_SIDED|95.0|-7.5|-3.9||The stat. test was not controlled for multiplicity. Data at visits following premature discont. of IMP or initiation of rescue med. were excluded from the analysis. Likewise for missing data due to COVID-19 pandemic.|Mixed Models Analysis|||"Least square (LS) means were calculated using a mixed model response model (MMRM) on post-baseline responses up to Week 8 with an unstructured covariance matrix, Kenward-Roger approximation to estimate denominator degrees of freedom and the mean modelled as follows:~Change from baseline in EASI = treatment x visit + baseline EASI x visit + region + baseline vIGA-AD.~The primary comparison between each active delgocitinib dose and delgocitinib cream vehicle was at Week 8."||-3.9|-7.5|<0.0001
72496313|NCT04426695|144522432|SUPERIORITY|||||||0.0457||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.0457
72559504|NCT00421304|144648901|SUPERIORITY|||||||0.747|||||||Wilcoxon's rank-sum test|||||||0.747
72442240|NCT03725722|144397542|SUPERIORITY||||||<|0.0001||||||Data collected after premature discont. of IMP due to COVID-19 were set to missing Week 8. Data collected after premature discont. of IMP due to reasons unrelated to COVID-19 or due to initiation of rescue med. were imputed as non-responders.|Multiple contrast test|"P-values adj. for multiple comparisons. Models with adj. p-value \<0.025 were stat. sign. diff. from a flat dose-response model.~Model: Linear model"||This endpoint was evaluated by determining if there was a dose-response relationship between the vIGA-AD response rate at Week 8 and the dose administered using the Multiple Comparison Procedure - Modelling (MCP-Mod) methodology. Several candidate parametric models were assumed and multiple comparison techniques were used to choose the model(s) most likely to represent the true underlying dose-response.||||<0.0001
72496314|NCT04426695|144522432|SUPERIORITY|||||||0.2153||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.2153
72496315|NCT04426695|144522433|SUPERIORITY|||||||0.0811||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.0811
72559505|NCT00421304|144648901|SUPERIORITY|||||||0.717|||||||Wilcoxon's rank-sum test|||||||0.717
72559506|NCT00421304|144648902|SUPERIORITY|||||||0.847|||||||Wilcoxon's rank-sum test|||||||0.847
72559507|NCT00421304|144648902|SUPERIORITY|||||||1|||||||Wilcoxon's rank-sum test|||||||1.000
72559508|NCT00421304|144648902|SUPERIORITY|||||||1|||||||Wilcoxon's rank-sum test|||||||1.000
72559509|NCT00421304|144648903|SUPERIORITY|||||||0.653|||||||Wilcoxon's rank-sum test|||||||0.653
72559510|NCT00421304|144648903|SUPERIORITY|||||||0.283|||||||Wilcoxon's rank-sum test|||||||0.283
72559511|NCT00421304|144648903|SUPERIORITY|||||||0.411|||||||Wilcoxon's rank-sum test|||||||0.411
72559512|NCT00421304|144648904|SUPERIORITY|||||||0.988|||||||Wilcoxon's rank-sum test|||||||0.988
72388043|NCT01681472|144284331|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
72442241|NCT03725722|144397542|SUPERIORITY||Risk Difference (RD)|8.2|||>|0.05|TWO_SIDED|95.0|-5.6|21.9||Data collected after premature discont. of IMP due to COVID-19 were set to missing Week 8. Data collected after premature discont. of IMP due to reasons unrelated to COVID-19 or due to initiation of rescue med. were imputed as non-responders.|Cochran-Mantel-Haenszel|||The difference in response rates between the active delgocitinib cream doses and delgocitinib cream vehicle was analysed separately for each of the active dose groups using the Cochran-Mantel-Haenszel test stratified by region and disease severity (baseline vIGA-AD score). The null hypothesis of no difference in response rates between the delgocitinib cream active doses and delgocitinib cream vehicle was tested against the 2-sided alternative test that there is a difference.||21.9|-5.6|>0.05
72388044|NCT01681472|144284332|SUPERIORITY|||||||0.0015|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0015
72388045|NCT01681472|144284332|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
72388046|NCT01681472|144284332|SUPERIORITY|||||||0.064|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0640
72388047|NCT01681472|144284332|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
72388048|NCT01681472|144284332|SUPERIORITY|||||||0.1213|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.1213
72388049|NCT01681472|144284332|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
72388050|NCT01681472|144284333|SUPERIORITY|||||||0.1791|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.1791
72388051|NCT01681472|144284333|SUPERIORITY|||||||0.4945|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.4945
72442242|NCT03725722|144397542|SUPERIORITY||Risk Difference (RD)|19.3|||<|0.05|TWO_SIDED|95.0|3.9|34.6||Data collected after premature discont. of IMP due to COVID-19 were set to missing Week 8. Data collected after premature discont. of IMP due to reasons unrelated to COVID-19 or due to initiation of rescue med. were imputed as non-responders.|Cochran-Mantel-Haenszel|||The difference in response rates between the active delgocitinib cream doses and delgocitinib cream vehicle was analysed separately for each of the active dose groups using the Cochran-Mantel-Haenszel test stratified by region and disease severity (baseline vIGA-AD score). The null hypothesis of no difference in response rates between the delgocitinib cream active doses and delgocitinib cream vehicle was tested against the 2-sided alternative test that there is a difference.||34.6|3.9|<0.05
72442243|NCT03725722|144397542|SUPERIORITY||Risk Difference (RD)|20.3|||<|0.05|TWO_SIDED|95.0|5.4|35.2||Data collected after premature discont. of IMP due to COVID-19 were set to missing Week 8. Data collected after premature discont. of IMP due to reasons unrelated to COVID-19 or due to initiation of rescue med. were imputed as non-responders.|Cochran-Mantel-Haenszel|||The difference in response rates between the active delgocitinib cream doses and delgocitinib cream vehicle was analysed separately for each of the active dose groups using the Cochran-Mantel-Haenszel test stratified by region and disease severity (baseline vIGA-AD score). The null hypothesis of no difference in response rates between the delgocitinib cream active doses and delgocitinib cream vehicle was tested against the 2-sided alternative test that there is a difference||35.2|5.4|<0.05
72496316|NCT04426695|144522433|SUPERIORITY|||||||0.6701||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.6701
72559513|NCT00421304|144648904|SUPERIORITY|||||||0.832|||||||Wilcoxon's rank-sum test|||||||0.832
72559514|NCT00421304|144648904|SUPERIORITY|||||||0.748|||||||Wilcoxon's rank-sum test|||||||0.748
72388052|NCT01681472|144284333|SUPERIORITY|||||||0.0014|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0014
72388053|NCT01681472|144284333|SUPERIORITY|||||||0.599|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.5990
72388054|NCT01681472|144284333|SUPERIORITY|||||||0.0303|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0303
72388055|NCT01681472|144284333|SUPERIORITY|||||||0.0107|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0107
72388056|NCT01681472|144284334|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
72559515|NCT00421304|144648905|SUPERIORITY|||||||0.28|||||||Wilcoxon's rank-sum test|||||||0.280
72559516|NCT00421304|144648905|SUPERIORITY|||||||0.108|||||||Wilcoxon's rank-sum test|||||||0.108
72559517|NCT00421304|144648905|SUPERIORITY|||||||1|||||||Wilcoxon's rank-sum test|||||||1.000
72622364|NCT05524948|144774638|OTHER||Adjusted Mean Difference|-418.86|STANDARD_ERROR_OF_MEAN|64.848|<|0.0001|TWO_SIDED|95.0|-547.56|-290.15|||ANCOVA|Analysis was performed using ANCOVA model with study product and gender as a factor and baseline concentration as a covariate.|For Hydrogen Sulfide|||-290.15|-547.56|<0.0001
72388057|NCT01681472|144284334|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
72388058|NCT01681472|144284334|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
72388059|NCT01681472|144284334|SUPERIORITY|||||||0.0125|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0125
72388060|NCT01681472|144284334|SUPERIORITY|||||||0.0017|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0017
72388061|NCT01681472|144284334|SUPERIORITY|||||||0.5286|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.5286
72388062|NCT01681472|144284335|OTHER||Correlation factor|-0.21666||||0.6063|TWO_SIDED||||||Pearson Correlation|||AUC(0-2h) vs. concentration in tumor||||0.6063
72388063|NCT01681472|144284335|OTHER||Correlation factor|0.54039||||0.2105|TWO_SIDED||||||Pearson Correlation|||AUC(0-2h) vs. concentration in tumor||||0.2105
72388064|NCT01681472|144284335|OTHER||Correlation factor|0.27618||||0.5079|TWO_SIDED||||||Pearson Correlation|||AUC(0-2h) vs. concentration in adjacent mucosa||||0.5079
72388065|NCT01681472|144284335|OTHER||Correlation factor|0.68223||||0.0913|TWO_SIDED||||||Pearson Correlation|||AUC(0-2h) vs. concentration in adjacent mucosa||||0.0913
72388066|NCT01681472|144284336|OTHER||Correlation factor|0.38298||||0.3964|TWO_SIDED||||||Pearson Correlation|||AUC(0-2h) vs. concentration in tumor||||0.3964
72388067|NCT01681472|144284336|OTHER||Correlation factor|0.27018||||0.5175|TWO_SIDED||||||Pearson Correlation|||AUC(0-2h) vs. concentration in tumor||||0.5175
72388068|NCT01681472|144284336|OTHER||Correlation factor|-0.02188||||0.959|TWO_SIDED||||||Pearson Correlation|||AUC(0-2h) vs. concentration in tumor||||0.9590
72388069|NCT01681472|144284336|OTHER||Correlation factor|0.45404||||0.3061|TWO_SIDED||||||Pearson Correlation|||AUC(0-2h) vs. concentration in adjacent mucosa||||0.3061
72388070|NCT01681472|144284336|OTHER||Correlation factor|0.34905||||0.3967|TWO_SIDED||||||Pearson Correlation|||AUC(0-2h) vs. concentration in adjacent mucosa||||0.3967
72388071|NCT01681472|144284336|OTHER||Correlation factor|0.07937||||0.8518|TWO_SIDED||||||Pearson Correlation|||AUC(0-2h) vs. concentration in adjacent mucosa||||0.8518
72388072|NCT01681472|144284337|OTHER||Correlation factor|0.73743||||0.0586|TWO_SIDED||||||Pearson Correlation|||AUC(0-2h) vs. conc in tumor||||0.0586
72622365|NCT05524948|144774638|OTHER||Adjusted Mean Difference|-108.9|STANDARD_ERROR_OF_MEAN|32.626||0.0012|TWO_SIDED|95.0|-173.66|-44.15|||ANCOVA|Analysis was performed using ANCOVA model with study product and gender as a factor and baseline concentration as a covariate.|For Methanethiol|||-44.15|-173.66|0.0012
72388073|NCT01681472|144284337|OTHER||Correlation factor|0.44757||||0.2661|TWO_SIDED||||||Pearson Correlation|||AUC(0-2h) vs. conc in tumor||||0.2661
72388074|NCT01681472|144284337|OTHER||Correlation factor|0.03292||||0.9506|TWO_SIDED||||||Pearson Correlation|||AUC(0-2h) vs. conc in tumor||||0.9506
72388075|NCT01681472|144284337|OTHER||Correlation factor|0.09033||||0.8315|TWO_SIDED||||||Pearson Correlation|||AUC(0-2h) vs. conc in tumor||||0.8315
72388076|NCT01681472|144284337|OTHER||Correlation factor|0.76502||||0.0451|TWO_SIDED||||||Pearson Correlation|||AUC(0-2h) vs. conc in adjacent mucosa||||0.0451
72388077|NCT01681472|144284337|OTHER||Correlation factor|0.34496||||0.4027|TWO_SIDED||||||Pearson Correlation|||AUC(0-2h) vs. concentration in adjacent mucosa||||0.4027
72388078|NCT01681472|144284337|OTHER||Correlation factor|-0.66295||||0.1513|TWO_SIDED||||||Pearson Correlation|||AUC(0-2h) vs. concentration in adjacent mucosa||||0.1513
72388079|NCT01681472|144284337|OTHER||Correlation factor|0.36854||||0.369|TWO_SIDED||||||Pearson Correlation|||AUC(0-2h) vs. concentration in adjacent mucosa||||0.3690
72388080|NCT01681472|144284338|OTHER||Correlation factor|0.23512||||0.5751|TWO_SIDED||||||Pearson Correlation|||AUC(0-2h) vs. concentration in adjacent mucosa||||0.5751
72559518|NCT00421304|144648906|SUPERIORITY|||||||0.742|||||||Wilcoxon's rank-sum test|||||||0.742
72559519|NCT00421304|144648906|SUPERIORITY|||||||0.486|||||||Wilcoxon's rank-sum test|||||||0.486
72559520|NCT00421304|144648906|SUPERIORITY|||||||0.49|||||||Wilcoxon's rank-sum test|||||||0.490
72559521|NCT00421304|144648907|SUPERIORITY|||||||1|||||||Wilcoxon's rank-sum test|||||||1.000
72559522|NCT00421304|144648908|SUPERIORITY|||||||0.05|||||||Wilcoxon's rank-sum test|||||||0.050
72559523|NCT00421304|144648909|SUPERIORITY|||||||0.008|||||||Wilcoxon's rank-sum test|||||||0.008
72559524|NCT00421304|144648910|SUPERIORITY|||||||0.012|||||||Wilcoxon's rank-sum test|||||||0.012
72559525|NCT00421304|144648911|SUPERIORITY||||||<|0.001|||||||Wilcoxon's rank-sum test|||||||<0.001
72559526|NCT02535923|144648968|SUPERIORITY|||||||0.04|||||||Mixed Models Analysis|||||||.04
72559527|NCT02535923|144648968|SUPERIORITY|||||||0.83|||||||Mixed Models Analysis|||||||.83
72559528|NCT02535923|144648969|SUPERIORITY|||||||0.83|||||||Mixed Models Analysis|||||||.83
72559529|NCT02535923|144648970|SUPERIORITY|||||||0.003|||||||Mixed Models Analysis|||||||.003
72559530|NCT02535923|144648971|SUPERIORITY|||||||0.16|||||||Mixed Models Analysis|||||||.16
72559531|NCT02535923|144648972|SUPERIORITY|||||||0.82|||||||Mixed Models Analysis|||||||.82
72559532|NCT00874276|144648983|SUPERIORITY_OR_OTHER||Kendall's Tau-B|0.6|STANDARD_ERROR_OF_MEAN|0.127||0.023|TWO_SIDED|95.0|0.35|0.85||This is the primary outcome, and there is no adjustment.|Wilcoxon (Mann-Whitney)|||We used a Wilcoxon test (and accompanying Kendal's Tau B) because these outcomes are outlier prone.||0.85|0.35|0.023
72559533|NCT00874276|144648984|SUPERIORITY_OR_OTHER||Kendall's Tau B|-0.23|STANDARD_ERROR_OF_MEAN|0.23||0.42|TWO_SIDED|95.0|-0.23|0.69|||Wilcoxon (Mann-Whitney)|||This is the same analysis as the previous, except we use the day 5 pharmacogenetics on the amount of time needed to clear one-half of dose of the drug. This is for the environmental dose. A positive (negative) Kendall's Tau is associated with the EGT allele being faster (slower) than lacking EGT in terms of metabolization of DCA.||0.69|-0.23|0.42
72559534|NCT00840840|144648985|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|ANOVA|Test/Reference Ratio of the mean x 100|101.45||||||90.0|97.71|105.33|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||105.33|97.71|
72559535|NCT00840840|144648986|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|ANOVA|Test/Reference Ratio of the mean x 100|103.05||||||90.0|101.25|104.88|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||104.88|101.25|
72559536|NCT00840840|144648987|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|ANOVA|Test/Reference Ratio of the mean x 100|102.94||||||90.0|101.08|104.83|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||104.83|101.08|
72559537|NCT00840840|144648988|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|ANOVA|Test/Reference Ratio of the mean x 100|99.68||||||90.0|92.41|107.52|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||107.52|92.41|
72559538|NCT00840840|144648989|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|ANOVA|Test/Reference Ratio of the mean x 100|101.48||||||90.0|94.73|108.71|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||108.71|94.73|
72559539|NCT00840840|144648990|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|ANOVA|Test/Reference Ratio of the mean x 100|100.17||||||90.0|91.95|109.13|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||109.13|91.95|
72559540|NCT02435433|144649050|SUPERIORITY||Hazard Ratio (HR)|0.71||||0.0199|TWO_SIDED|95.0|0.531|0.949|||Log Rank||Stratified analysis|||0.949|0.531|0.0199
72559541|NCT02435433|144649051|SUPERIORITY||Hazard Ratio (HR)|0.452|||<|0.0001|TWO_SIDED|95.0|0.339|0.603|||Log Rank||Stratified analysis|||0.603|0.339|<0.0001
72388081|NCT01681472|144284338|OTHER||Correlation factor|0.02576||||0.9672|TWO_SIDED||||||Pearson Correlation|||AUC(0-2h) vs. concentration in adjacent mucosa||||0.9672
72388082|NCT01681472|144284338|OTHER||Correlation factor|0.68778||||0.0594|TWO_SIDED||||||Pearson Correlation|||AUC(0-2h) vs. conc in tumor||||0.0594
72388083|NCT01681472|144284338|OTHER||Correlation factor|0.11512||||0.8281|TWO_SIDED||||||Pearson Correlation|||AUC(0-2h) vs. conc in tumor||||0.8281
72388084|NCT01681472|144284339|OTHER|||||||0.0451|||||||pearson|||||||0.0451
72559542|NCT02435433|144649052|SUPERIORITY||Hazard Ratio (HR)|0.427|||<|0.0001|TWO_SIDED|95.0|0.313|0.582|||Log Rank||Stratified analysis|||0.582|0.313|<0.0001
72622366|NCT05524948|144774638|OTHER||Adjusted Mean Difference|-26.17|STANDARD_ERROR_OF_MEAN|22.909||0.2561|TWO_SIDED|95.0|-71.64|19.29|||ANCOVA|Analysis was performed using ANCOVA model with study product and gender as a factor and baseline concentration as a covariate.|For Dimethyl Sulfide|||19.29|-71.64|0.2561
72388085|NCT01681472|144284340|OTHER||Correlation factor|0.42972||||0.3359|TWO_SIDED||||||Pearson Correlation|||Correlation for AMT gene expression||||0.3359
72388086|NCT01681472|144284340|OTHER||Correlation factor|0.75404||||0.0307|TWO_SIDED||||||Pearson Correlation|||Correlation for AMT gene expression||||0.0307
72388087|NCT01681472|144284340|OTHER||Correlation factor|-0.7073||||0.116|TWO_SIDED||||||Pearson Correlation|||Correlation for AMT gene expression||||0.1160
72388088|NCT01681472|144284340|OTHER||Correlation factor|-0.47193||||0.2377|TWO_SIDED||||||Pearson Correlation|||Correlation for AMT gene expression||||0.2377
72388089|NCT01681472|144284340|OTHER||Correlation factor|0.88128||||0.0087|TWO_SIDED||||||Pearson Correlation|||Correlation for PCFT gene expression||||0.0087
72388090|NCT01681472|144284340|OTHER||Correlation factor|0.58502||||0.1277|TWO_SIDED||||||Pearson Correlation|||Correlation for PCFT gene expression||||0.1277
72388091|NCT01681472|144284340|OTHER||Correlation factor|0.89976||||0.0146|TWO_SIDED||||||Pearson Correlation|||Correlation for PCFT gene expression||||0.0146
72559543|NCT02435433|144649053|SUPERIORITY||Odds Ratio (OR)|4.6||||0.1697|TWO_SIDED|95.0|0.6|37.3|||Cochran-Mantel-Haenszel||Stratified analysis|||37.3|0.6|0.1697
72559544|NCT02435433|144649057|SUPERIORITY||Hazard Ratio (HR)|0.799||||0.2382|TWO_SIDED|95.0|0.545|1.171|||Log Rank||Stratified analysis|||1.171|0.545|0.2382
72559545|NCT04406194|144649112|EQUIVALENCE|0.80-1.25 margins for equivalence|Mean Ratio|0.9684||||0|TWO_SIDED|90.0|0.94|0.9977|||ANOVA|||||0.9977|0.9400|0.0000
72559546|NCT04406194|144649113|EQUIVALENCE|0.80 - 1.25 equivalence margin is required.|Mean Ratio|1.0555||||0.0155|TWO_SIDED|90.0|0.9292|1.1989|||ANOVA|||||1.1989|0.9292|0.0155
72559547|NCT04406194|144649114|EQUIVALENCE|0.80 - 1.25 equivalence margin is not required.|Mean Ratio|0.9719||||0|TWO_SIDED|90.0|0.944|1.0006|||ANOVA|||||1.0006|0.9440|0.0000
72559548|NCT02442687|144649136|OTHER|||||||0.034||||||The p-value was not adjusted for multiple comparison. The threshold for statistical significance was \<0.05.|ANCOVA|Change from baseline as the dependent variable, baseline value as a covariate, and treatment group and diabetes stratum as factors.||||||0.034
72559549|NCT02442687|144649136|OTHER|||||||0.1731||||||The p-value was not adjusted for multiple comparison. The threshold for statistical significance was \<0.05.|ANCOVA|Change from baseline as the dependent variable, baseline value as a covariate, and treatment group and diabetes stratum as factors.||||||0.1731
72559550|NCT02442687|144649137|OTHER|||||||0.5276||||||The p-value is not adjusted for multiple comparisons. The threshold for statistical significance was \<0.05.|ANCOVA|The change from baseline as the dependent variable, baseline value as a covariate, and treatment group and diabetes stratum as factors.||||||0.5276
72559551|NCT02442687|144649137|OTHER|||||||0.4968||||||The p-value is not adjusted for multiple comparisons. The threshold for statistical significance was \<0.05.|ANCOVA|The change from baseline as the dependent variable, baseline value as a covariate, and treatment group and diabetes stratum as factors.||||||0.4968
72559552|NCT02442687|144649138|OTHER|||||||0.2591||||||The p-value is not adjusted for multiple comparisons. The threshold for statistical significance was \<0.05.|ANCOVA|Change from baseline as the dependent variable, baseline value as a covariate, and treatment group and diabetes stratum as factors.||||||0.2591
72388092|NCT01681472|144284340|OTHER||Correlation factor|0.11497||||0.7863|TWO_SIDED||||||Pearson Correlation|||Correlation for PCFT gene expression||||0.7863
72442244|NCT03725722|144397542|SUPERIORITY||Risk Difference (RD)|38.3|||<|0.0001|TWO_SIDED|95.0|22.3|54.3||Data collected after premature discont. of IMP due to COVID-19 were set to missing Week 8. Data collected after premature discont. of IMP due to reasons unrelated to COVID-19 or due to initiation of rescue med. were imputed as non-responders.|Cochran-Mantel-Haenszel|||The difference in response rates between the active delgocitinib cream doses and delgocitinib cream vehicle was analysed separately for each of the active dose groups using the Cochran-Mantel-Haenszel test stratified by region and disease severity (baseline vIGA-AD score). The null hypothesis of no difference in response rates between the delgocitinib cream active doses and delgocitinib cream vehicle was tested against the 2-sided alternative test that there is a difference||54.3|22.3|<0.0001
72442245|NCT03725722|144397543|SUPERIORITY||||||<|0.0001||||||Data collected after premature discont. of IMP due to COVID-19 were set to missing Week 8. Data collected after premature discont. of IMP due to reasons unrelated to COVID-19 or due to initiation of rescue med. were imputed as non-responders.|Multiple contrast test|"P-values were adj. for multiple comparisons. Models with adj. p-value \<0.025 were stat. sign. diff. from a flat dose-response model.~Model:Emax model"||This endpoint was evaluated by determining if there was a dose-response relationship between EASI75 at Week 8 and the dose administered using the Multiple Comparison Procedure - Modelling (MCP-Mod) methodology. Several candidate parametric models were assumed and multiple comparison techniques were used to choose the model(s) most likely to represent the true underlying dose-response||||<0.0001
72442246|NCT03725722|144397543|SUPERIORITY||Risk Difference (RD)|19.7|||<|0.05|TWO_SIDED|95.0|1.8|37.6||Data collected after premature discont. of IMP due to COVID-19 were set to missing Week 8. Data collected after premature discont. of IMP due to reasons unrelated to COVID-19 or due to initiation of rescue med. were imputed as non-responders.|Cochran-Mantel-Haenszel|||The difference in response rates between the active delgocitinib cream doses and delgocitinib cream vehicle was analysed separately for each of the active dose groups using the Cochran-Mantel-Haenszel test stratified by region and disease severity (baseline vIGA-AD score). The null hypothesis of no difference in response rates between the delgocitinib cream active doses and delgocitinib cream vehicle was tested against the 2-sided alternative test that there is a difference||37.6|1.8|<0.05
72496317|NCT04426695|144522433|SUPERIORITY|||||||0.2006||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.2006
72496318|NCT04426695|144522433|SUPERIORITY|||||||0.3313||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.3313
72496319|NCT04426695|144522433|SUPERIORITY|||||||0.5542||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.5542
72496320|NCT04426695|144522433|SUPERIORITY|||||||0.2214||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.2214
72496321|NCT04426695|144522434|SUPERIORITY|||||||0.0389||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.0389
72622367|NCT05524948|144774639|OTHER||Adjusted Mean Difference|-721.58|STANDARD_ERROR_OF_MEAN|94.584|<|0.0001|TWO_SIDED|95.0|-909.31|-533.86|||ANCOVA|Analysis was performed using ANCOVA model with study product and gender as a factor and baseline concentration as a covariate.||||-533.86|-909.31|<0.0001
72388093|NCT01681472|144284340|OTHER||Correlation factor|0.97624||||0.0002|TWO_SIDED||||||Pearson Correlation|||Correlation for FPGS gene expression||||0.0002
72388094|NCT01681472|144284340|OTHER||Correlation factor|0.88682||||0.0033|TWO_SIDED||||||Pearson Correlation|||Correlation for FPGS gene expression||||0.0033
72388095|NCT01681472|144284340|OTHER||Correlation factor|-0.64743||||0.1645|TWO_SIDED||||||Pearson Correlation|||Correlation for FPGS gene expression||||0.1645
72388096|NCT01681472|144284340|OTHER||Correlation factor|0.17664||||0.6756|TWO_SIDED||||||Pearson Correlation|||Correlation for FPGS gene expression||||0.6756
72388097|NCT01681472|144284340|OTHER||Correlation factor|0.94364||||0.0014|TWO_SIDED||||||Pearson Correlation|||Correlation for MTHFS gene expression||||0.0014
72388098|NCT01681472|144284340|OTHER||Correlation factor|0.43194||||0.2852|TWO_SIDED||||||Pearson Correlation|||Correlation for MTHFS gene expression||||0.2852
72388099|NCT01681472|144284340|OTHER||Correlation factor|0.58419||||0.2234|TWO_SIDED||||||Pearson Correlation|||Correlation for MTHFS gene expression||||0.2234
72388100|NCT01681472|144284340|OTHER||Correlation factor|0.9584||||0.0002|TWO_SIDED||||||Pearson Correlation|||Correlation for MTHFS gene expression||||0.0002
72388101|NCT01681472|144284340|OTHER||Correlation factor|-0.38987||||0.3873|TWO_SIDED||||||Pearson Correlation|||Correlation for ABCC3 gene expression||||0.3873
72388102|NCT01681472|144284340|OTHER||Correlation factor|-0.25891||||0.5358|TWO_SIDED||||||Pearson Correlation|||Correlation for ABCC3 gene expression||||0.5358
72388103|NCT01681472|144284340|OTHER||Correlation factor|0.777||||0.0691|TWO_SIDED||||||Pearson Correlation|||Correlation for ABCC3 gene expression||||0.0691
72388104|NCT01681472|144284340|OTHER||Correlation factor|0.00322||||0.994|TWO_SIDED||||||Pearson Correlation|||Correlation for ABCC3 gene expression||||0.9940
72388105|NCT01681472|144284340|OTHER||Correlation factor|0.93711||||0.0018|TWO_SIDED||||||Pearson Correlation|||Correlation for GGH gene expression||||0.0018
72388106|NCT01681472|144284340|OTHER||Correlation factor|0.46883||||0.2413|TWO_SIDED||||||Pearson Correlation|||Correlation for GGH gene expression||||0.2413
72496322|NCT04426695|144522434|SUPERIORITY|||||||0.5208||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.5208
72442247|NCT03725722|144397543|SUPERIORITY||Risk Difference (RD)|23.5|||<|0.05|TWO_SIDED|95.0|5.8|41.2||Data collected after premature discont. of IMP due to COVID-19 were set to missing Week 8. Data collected after premature discont. of IMP due to reasons unrelated to COVID-19 or due to initiation of rescue med. were imputed as non-responders.|Cochran-Mantel-Haenszel|||The difference in response rates between the active delgocitinib cream doses and delgocitinib cream vehicle was analysed separately for each of the active dose groups using the Cochran-Mantel-Haenszel test stratified by region and disease severity (baseline vIGA-AD score). The null hypothesis of no difference in response rates between the delgocitinib cream active doses and delgocitinib cream vehicle was tested against the 2-sided alternative test that there is a difference||41.2|5.8|<0.05
72496323|NCT04426695|144522434|SUPERIORITY|||||||0.1079||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.1079
72496324|NCT04426695|144522434|SUPERIORITY|||||||0.3315||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.3315
72496325|NCT04426695|144522434|SUPERIORITY|||||||0.5797||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.5797
72496326|NCT04426695|144522434|SUPERIORITY|||||||0.3036||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.3036
72496327|NCT04426695|144522435|SUPERIORITY|||||||0.0364||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.0364
72496328|NCT04426695|144522435|SUPERIORITY|||||||0.2795||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.2795
72496329|NCT04426695|144522435|SUPERIORITY|||||||0.0588||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.0588
72496330|NCT04426695|144522435|SUPERIORITY|||||||0.0364||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.0364
72496331|NCT04426695|144522435|SUPERIORITY|||||||0.2795||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.2795
72496332|NCT04426695|144522435|SUPERIORITY|||||||0.0588||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.0588
72496333|NCT04426695|144522436|SUPERIORITY|||||||0.2635||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.2635
72496334|NCT04426695|144522436|SUPERIORITY|||||||0.8013||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.8013
72619045|NCT05181657|144768761|OTHER|The intervention effect was determined via a two sided, 0.05 level of significance, multivariable Poisson regression model, with Intervention group as the primary predictor.|Risk Ratio (RR)|1.45|||<|0.05|TWO_SIDED|95.0|1.18|1.78||"Alpha significance levels used:~For the primary predictor (i.e., intervention group): alpha=0.05; For covariates: alpha=0.10; For interactions: alpha=0.15"|Poisson Regression||The estimate refers to the relative risk of getting a COVID-19 test onsite (Intervention/Control). Also, the above estimate is from the unadjusted Poisson regression model (i.e., model not adjusted for covariates and interactions).|To assess whether the active intervention was more successful than the control condition at increasing COVID-19 testing, we used univariable and multivariable Poisson regression models, with whether one received onsite testing right after the intervention as the outcome and intervention group as the main predictor. Potential clustering due to the randomization by week was accounted for by specifying an exchangeable correlation structure for participants who were recruited during the same week.||1.78|1.18|<0.05
72496335|NCT04426695|144522436|SUPERIORITY|||||||0.416||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.4160
72496336|NCT04426695|144522436|SUPERIORITY|||||||0.2194||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.2194
72496337|NCT04426695|144522436|SUPERIORITY|||||||0.324||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.3240
72496338|NCT04426695|144522436|SUPERIORITY|||||||0.1981||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.1981
72559553|NCT02442687|144649138|OTHER|||||||0.1806||||||The p-value is not adjusted for multiple comparisons. The threshold for statistical significance was \<0.05.|ANCOVA|Change from baseline as the dependent variable, baseline value as a covariate, and treatment group and diabetes stratum as factors.||||||0.1806
72559554|NCT02442687|144649139|OTHER|||||||0.0882||||||The p-value is not adjusted for multiple comparisons. The threshold for statistical significance was \<0.05.|ANCOVA|The change from baseline as the dependent variable, baseline value as a covariate, and treatment group and diabetes stratum as factors.||||||0.0882
72559555|NCT02442687|144649139|OTHER|||||||0.253||||||The p-value is not adjusted for multiple comparisons. The threshold for statistical significance was \<0.05.|ANCOVA|The change from baseline as the dependent variable, baseline value as a covariate, and treatment group and diabetes stratum as factors.||||||0.2530
72559556|NCT00270634|144649156|NON_INFERIORITY_OR_EQUIVALENCE|The sample size was determined holding the probability of a type-I error at a = 0.05, and the power at 0.76. The rate of BPAR at 6 months posttransplant was assumed to be 0.20 in the control arm, and the noninferiority margin was chosen to be -0.15. A sample size for this phase-2b trial is determined to be 76 subjects in each dose group or a total of 304 patients. Assuming a 10% dropout rate during the study, ∼332 subjects were to be proportionally randomized in this study.|Weighted Average Difference|-3.2|||||ONE_SIDED|95.0||1.3|||t-test, 1 sided||The upper bound of the confidence interval was a measure of non-inferiority of VCS to TAC. VCS was considered non-inferior to TAC if the upper one-sided 95% confidence bound was less than 15%.|The 6-month BPAR rate was used to calculate an estimate of the difference in rates between each VCS group and TAC, combining across pooled investigative center strata, weighted by the number of patients in each of the pooled center strata. The overall standard error was estimated for the linear combination of proportions. Using this statistic and its standard error, the upper bound one-sided 95% C.I. was constructed for the difference in BPAR rates between groups (VCS - TAC).||1.3||
72559557|NCT00270634|144649156|NON_INFERIORITY_OR_EQUIVALENCE|The sample size was determined holding the probability of a type-I error at a = 0.05, and the power at 0.76. The rate of BPAR at 6 months posttransplant was assumed to be 0.20 in the control arm, and the noninferiority margin was chosen to be -0.15. A sample size for this phase-2b trial is determined to be 76 subjects in each dose group or a total of 304 patients. Assuming a 10% dropout rate during the study, ∼332 subjects were to be proportionally randomized in this study.|Weighted Average Difference|4.6|||||ONE_SIDED|95.0||10.8|||t-test, 1 sided||The upper bound of the confidence interval was a measure of non-inferiority of VCS to TAC. VCS was considered non-inferior to TAC if the upper one-sided 95% confidence bound was less than 15%.|||10.8||
72559558|NCT00270634|144649156|NON_INFERIORITY_OR_EQUIVALENCE|The sample size was determined holding the probability of a type-I error at a = 0.05, and the power at 0.76. The rate of BPAR at 6 months posttransplant was assumed to be 0.20 in the control arm, and the noninferiority margin was chosen to be -0.15. A sample size for this phase-2b trial is determined to be 76 subjects in each dose group or a total of 304 patients. Assuming a 10% dropout rate during the study, ∼332 subjects were to be proportionally randomized in this study.|Weighted Average Difference|4.9|||||ONE_SIDED|95.0||11.4|||t-test, 1 sided||The upper bound of the confidence interval was a measure of non-inferiority of VCS to TAC. VCS was considered non-inferior to TAC if the upper one-sided 95% confidence bound was less than 15%.|||11.4||
72559559|NCT00354835|144649170|SUPERIORITY_OR_OTHER_LEGACY||The incidence of anemia|0.2613|||||ONE_SIDED|95.0||0.31||||||Compare incidence of Anemia to historical rate of 0.40 from D9803, which is Randomized Study of VCR, Actinomycin-D, and CPM (VAC) vs. VAC alternating with VCR, Topotecan, and CPM (VTC) for Patients with Intermediate Risk RMS. Comparing the incidence of anemia with VAC on ARST0531 to the historical rate of 0.40 with VAC on D9803. The 95% one-sided confidence interval for the incidence of anemia will be calculated and evaluated to see if the interval contains the null rate of 0.40.||0.31||
72622368|NCT05524948|144774640|OTHER||Adjusted Mean Difference|-567.89|STANDARD_ERROR_OF_MEAN|68.09|<|0.0001|TWO_SIDED|95.0|-703.03|-432.75|||ANCOVA|Analysis was performed using ANCOVA model with study product and gender as a factor and baseline concentration as a covariate.|For Hydrogen Sulfide|||-432.75|-703.03|<0.0001
72388107|NCT01681472|144284340|OTHER||Correlation factor|-0.09737||||0.8544|TWO_SIDED||||||Pearson Correlation|||Correlation for GGH gene expression||||0.8544
72388108|NCT01681472|144284340|OTHER||Correlation factor|0.78928||||0.0199|TWO_SIDED||||||Pearson Correlation|||Correlation for GGH gene expression||||0.0199
72388109|NCT01681472|144284340|OTHER||Correlation factor|0.82963||||0.0209|TWO_SIDED||||||Pearson Correlation|||Correlation for ABCC1 gene expression||||0.0209
72388110|NCT01681472|144284340|OTHER||Correlation factor|-0.16724||||0.6922|TWO_SIDED||||||Pearson Correlation|||Correlation for ABCC1 gene expression||||0.6922
72388111|NCT01681472|144284340|OTHER||Correlation factor|0.14436||||0.785|TWO_SIDED||||||Pearson Correlation|||Correlation for ABCC1 gene expression||||0.7850
72388112|NCT01681472|144284340|OTHER||Correlation factor|0.74757||||0.033|TWO_SIDED||||||Pearson Correlation|||Correlation for ABCC1 gene expression||||0.0330
72388113|NCT01681472|144284340|OTHER||Correlation factor|0.32113||||0.4825|TWO_SIDED||||||Pearson Correlation|||Correlation for MTHFD1L gene expression||||0.4825
72388114|NCT01681472|144284340|OTHER||Correlation factor|0.3716||||0.3647|TWO_SIDED||||||Pearson Correlation|||Correlation for MTHFD1L gene expression||||0.3647
72388115|NCT01681472|144284340|OTHER||Correlation factor|0.20955||||0.6903|TWO_SIDED||||||Pearson Correlation|||Correlation for MTHFD1L gene expression||||0.6903
72388116|NCT01681472|144284340|OTHER||Correlation factor|0.74459||||0.0341|TWO_SIDED||||||Pearson Correlation|||Correlation for MTHFD1L gene expression||||0.0341
72388117|NCT01681472|144284340|OTHER||Correlation factor|0.50966||||0.2426|TWO_SIDED||||||Pearson Correlation|||Correlation for SHMT1 gene expression||||0.2426
72559560|NCT00354835|144649170|SUPERIORITY_OR_OTHER_LEGACY||The incidence of nausea or hepatopathy|0.027|||||ONE_SIDED|95.0||0.0449||||||Compare incidence of Nausea or Hepatopathy to historical rate of 0.05 from D9803, which is Randomized Study of VCR, Actinomycin-D, and CPM (VAC) vs. VAC alternating with VCR, Topotecan, and CPM (VTC) for Patients with Intermediate Risk RMS. The 95% one-sided confidence interval for the incidence of nausea or hepatopathy will be calculated and evaluated to see if the interval contains the null rate of 0.05.||0.0449||
72559561|NCT00354835|144649170|SUPERIORITY_OR_OTHER_LEGACY||The incidence of febrile neutropenia|0.1351|||||ONE_SIDED|95.0||0.1729||||||Compare incidence of Febrile Neutropenia to historical rate of 0.50 from D9803, which is Randomized Study of VCR, Actinomycin-D, and CPM (VAC) vs. VAC alternating with VCR, Topotecan, and CPM (VTC) for Patients with Intermediate Risk RMS. The 95% one-sided confidence interval for the incidence of febrile neutropenia will be calculated and evaluated to see if the interval contains the null rate of 0.50.||0.1729||
72619046|NCT01524705|144768791|SUPERIORITY||Wilcoxon||||<|0.024||||||Wilcoxon rank sum test was used due to nonnormality distribution|Wilcoxon (Mann-Whitney)|||Two-tailed t test with type I error = 0.05, a sample of 110 participants (55 per group) would give 90% power to detect a difference of a mean change from baseline of 5 CV units (SD = 8) between control and treatment groups. An ANCOVA model, adjusting for baseline value and clinical site, was to be performed. If residual values from the ANCOVA indicated nonnormality in distribution by Shapiro-Wilk testing, a Wilcoxon rank sum test was used instead.||||<0.024
72388118|NCT01681472|144284340|OTHER||Correlation factor|0.67853||||0.0643|TWO_SIDED||||||Pearson Correlation|||Correlation for SHMT1 gene expression||||0.0643
72388119|NCT01681472|144284340|OTHER||Correlation factor|0.05531||||0.9171|TWO_SIDED||||||Pearson Correlation|||Correlation for SHMT1 gene expression||||0.9171
72388120|NCT01681472|144284340|OTHER||Correlation factor|0.59183||||0.1222|TWO_SIDED||||||Pearson Correlation|||Correlation for SHMT1 gene expression||||0.1222
72388121|NCT01681472|144284340|OTHER||Correlation factor|0.8104||||0.0271|TWO_SIDED||||||Pearson Correlation|||Correlation for SHMT2 gene expression||||0.0271
72388122|NCT01681472|144284340|OTHER||Correlation factor|0.86266||||0.0058|TWO_SIDED||||||Pearson Correlation|||Correlation for SHMT2 gene expression||||0.0058
72388123|NCT01681472|144284340|OTHER||Correlation factor|-0.71666||||0.109|TWO_SIDED||||||Pearson Correlation|||Correlation for SHMT2 gene expression||||0.1090
72388124|NCT01681472|144284340|OTHER||Correlation factor|0.55508||||0.1533|TWO_SIDED||||||Pearson Correlation|||Correlation for SHMT2 gene expression||||0.1533
72388125|NCT01681472|144284340|OTHER||Correlation factor|0.318||||0.487|TWO_SIDED||||||Pearson Correlation|||Correlation for RFC-1 gene expression||||0.4870
72388126|NCT01681472|144284340|OTHER||Correlation factor|0.23312||||0.5785|TWO_SIDED||||||Pearson Correlation|||Correlation for RFC-1 gene expression||||0.5785
72388127|NCT01681472|144284340|OTHER||Correlation factor|-0.0245||||0.9632|TWO_SIDED||||||Pearson Correlation|||Correlation for RFC-1 gene expression||||0.9632
72388128|NCT01681472|144284340|OTHER||Correlation factor|0.64565||||0.0838|TWO_SIDED||||||Pearson Correlation|||Correlation for RFC-1 gene expression||||0.0838
72388129|NCT00795145|144284352|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.47||||||90.0|-0.7|3.64||||||Inferential analysis at 0.5 hour post-dose||3.64|-0.7|
72388130|NCT00795145|144284352|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.96||||||90.0|-5.13|-0.79||||||Inferential analysis at 1 hour post-dose||-0.79|-5.13|
72388131|NCT00795145|144284352|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.53||||||90.0|-7.7|-3.36||||||Inferential analysis at 2 hour post-dose||-3.36|-7.70|
72388132|NCT00795145|144284352|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.4||||||90.0|-1.77|2.57||||||Inferential analysis at 4 hour post-dose||2.57|-1.77|
72388133|NCT00795145|144284352|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.37||||||90.0|-3.54|0.8||||||Inferential analysis at 8 hour post-dose||0.80|-3.54|
72388134|NCT00795145|144284352|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.01||||||90.0|-1.16|3.18||||||Inferential analysis at 12 hour post-dose||3.18|-1.16|
72388135|NCT00795145|144284352|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.64||||||90.0|-2.81|1.53||||||Inferential analysis at 24 hour post-dose||1.53|-2.81|
72388136|NCT00795145|144284352|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.49||||||90.0|0.32|4.66||||||Inferential analysis at 0.5 hour post-dose||4.66|0.32|
72496339|NCT00559273|144522452|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||The p-value was the probability that the number of responders is greater than or equal to the observed number, although the true response rate was smaller or equal to 60%. Null hypothesis (H0): p-value \<=0.6; alternate hypothesis (H1): p-value \>0.6.||||<0.0001
72388137|NCT00795145|144284352|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.78||||||90.0|-3.95|0.39||||||Inferential analysis at 1 hour post-dose||0.39|-3.95|
72388138|NCT00795145|144284352|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.51||||||90.0|-9.68|-5.34||||||Inferential analysis at 2 hour post-dose||-5.34|-9.68|
72388139|NCT00795145|144284352|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.47||||||90.0|1.3|5.64||||||Inferential analysis at 4 hour post-dose||5.64|1.30|
72388140|NCT00795145|144284352|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.13||||||90.0|-1.04|3.3||||||Inferential analysis at 8 hour post-dose||3.30|-1.04|
72388141|NCT00795145|144284352|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.47||||||90.0|-0.7|3.64||||||Inferential analysis at 12 hour post-dose||3.64|-0.70|
72388142|NCT00795145|144284352|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.8||||||90.0|-0.37|3.97||||||Inferential analysis at 24 hour post-dose||3.97|-0.37|
72388143|NCT00795145|144284353|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.27||||||90.0|1.1|5.44||||||Inferential analysis at 0.5 hour post-dose||5.44|1.10|
72388144|NCT00795145|144284353|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.83||||||90.0|4.66|9.0||||||Inferential analysis at 1 hour post-dose||9.00|4.66|
72388145|NCT00795145|144284353|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.27||||||90.0|8.1|12.44||||||Inferential analysis at 2 hour post-dose||12.44|8.10|
72388146|NCT00795145|144284353|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.84||||||90.0|7.67|12.01||||||Inferential analysis at 4 hour post-dose||12.01|7.67|
72388147|NCT00795145|144284353|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.4||||||90.0|7.23|11.58||||||Inferential analysis at 8 hour post-dose||11.58|7.23|
72388148|NCT00795145|144284353|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.05||||||90.0|4.87|9.22||||||Inferential analysis at 12 hour post-dose||9.22|4.87|
72388149|NCT00795145|144284353|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.52||||||90.0|4.35|8.69||||||Inferential analysis at 24 hour post-dose||8.69|4.35|
72388150|NCT00795145|144284354|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.49||||||90.0|-5.54|2.57||||||Inferential analysis at 0.5 hour post-dose||2.57|-5.54|
72388151|NCT00795145|144284354|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.45||||||90.0|-11.51|-3.4||||||Inferential analysis at 1 hour post-dose||-3.40|-11.51|
72388152|NCT00795145|144284354|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.75||||||90.0|-9.81|-1.7||||||Inferential analysis at 2 hour post-dose||-1.70|-9.81|
72388153|NCT00795145|144284354|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.92||||||90.0|-4.97|3.13||||||Inferential analysis at 4 hour post-dose||3.13|-4.97|
72388154|NCT00795145|144284354|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.64||||||90.0|-9.69|-1.58||||||Inferential analysis at 8 hour post-dose||-1.58|-9.69|
72388155|NCT00795145|144284354|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.29||||||90.0|-6.34|1.77||||||Inferential analysis at 12 hour post-dose||1.77|-6.34|
72496340|NCT00559273|144522452|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||The p-value was the probability that the number of responders is greater than or equal to the observed number, although the true response rate was smaller or equal to 60%. Null hypothesis (H0): p-value \<=0.6; alternate hypothesis (H1): p-value \>0.6.||||<0.0001
72388156|NCT00795145|144284354|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.59||||||90.0|-4.64|3.47||||||Inferential analysis at 24 hour post-dose||3.47|-4.64|
72388157|NCT00795145|144284354|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.49||||||90.0|-7.54|0.57||||||Inferential analysis at 0.5 hour post-dose||0.57|-7.54|
72388158|NCT00795145|144284354|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.19||||||90.0|-16.24|-8.13||||||Inferential analysis at 1 hour post-dose||-8.13|-16.24|
72388159|NCT00795145|144284354|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.39||||||90.0|-18.44|-10.33||||||Inferential analysis at 2 hour post-dose||-10.33|-18.44|
72388160|NCT00795145|144284354|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.19||||||90.0|-6.24|1.87||||||Inferential analysis at 4 hour post-dose||1.87|-6.24|
72388161|NCT00795145|144284354|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.1||||||90.0|-2.95|5.15||||||Inferential analysis at 8 hour post-dose||5.15|-2.95|
72388162|NCT00795145|144284354|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.11||||||90.0|-3.94|4.17||||||Inferential analysis at 12 hour post-dose||4.17|-3.94|
72388163|NCT00795145|144284354|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.68||||||90.0|-1.37|6.73||||||Inferential analysis at 24 hour post-dose||6.73|-1.37|
72388164|NCT01786668|144284398|SUPERIORITY_OR_OTHER||Risk Difference (RD)|15.8|||||TWO_SIDED|95.0|5.0|30.3|||Emax Model|||Emax model - 95% Confidence Interval represents 95% Credible Interval||30.3|5.0|
72388165|NCT01786668|144284398|SUPERIORITY_OR_OTHER||Risk Difference (RD)|22.9|||||TWO_SIDED|95.0|8.4|37.7|||Emax Model|||Emax model - 95% Confidence Interval represents 95% Credible Interval||37.7|8.4|
72388166|NCT01786668|144284398|SUPERIORITY_OR_OTHER||Risk Difference (RD)|27.3|||||TWO_SIDED|95.0|10.7|43.4|||Emax Model|||Emax model - 95% Confidence Interval represents 95% Credible Interval||43.4|10.7|
72388167|NCT01786668|144284399|SUPERIORITY_OR_OTHER||Risk Difference (RD)|10.75|STANDARD_ERROR_OF_MEAN|9.77||0.271|TWO_SIDED|95.0|-8.41|29.9|||Normal approximation for two proportions|||||29.90|-8.41|0.271
72388168|NCT01786668|144284399|SUPERIORITY_OR_OTHER||Risk Difference (RD)|39.59|STANDARD_ERROR_OF_MEAN|8.8|<|0.001|TWO_SIDED|95.0|22.35|56.83|||Normal approximation for two proportions|||||56.83|22.35|<0.001
72496341|NCT00559273|144522453|NON_INFERIORITY_OR_EQUIVALENCE|MIRCERA treatment was regarded as non-inferior to the darbepoetin alfa reference group if the lower limit of the CI was greater than -0.75 g/dL.|Adjusted Mean Difference|-0.036|STANDARD_ERROR_OF_MEAN|0.1097|<|0.0001|TWO_SIDED|95.0|-0.252|0.18|||ANCOVA|||||0.180|-0.252|<0.0001
72388169|NCT01786668|144284399|SUPERIORITY_OR_OTHER||Risk Difference (RD)|14.59|STANDARD_ERROR_OF_MEAN|9.74||0.134|TWO_SIDED|95.0|-4.5|33.69|||Normal approximation for two proportions|||||33.69|-4.50|0.134
72388170|NCT01786668|144284400|SUPERIORITY_OR_OTHER||Risk Difference (RD)|12.93|STANDARD_ERROR_OF_MEAN|9.24||0.162|TWO_SIDED|95.0|-5.17|31.04|||Normal approximation for two proportions|||Week 2||31.04|-5.17|0.162
72388171|NCT01786668|144284400|SUPERIORITY_OR_OTHER||Risk Difference (RD)|5.24|STANDARD_ERROR_OF_MEAN|9.02||0.561|TWO_SIDED|95.0|-12.44|22.92|||Normal approximation for two proportions|||Week 2||22.92|-12.44|0.561
72388172|NCT01786668|144284400|SUPERIORITY_OR_OTHER||Risk Difference (RD)|7.16|STANDARD_ERROR_OF_MEAN|9.09||0.43|TWO_SIDED|95.0|-10.65|24.97|||Normal approximation for two proportions|||Week 2||24.97|-10.65|0.430
72388173|NCT01786668|144284400|SUPERIORITY_OR_OTHER||Risk Difference (RD)|14.74|STANDARD_ERROR_OF_MEAN|9.57||0.123|TWO_SIDED|95.0|-4.01|33.5|||Normal approximation for two proportions|||Week 4||33.50|-4.01|0.123
72388174|NCT01786668|144284400|SUPERIORITY_OR_OTHER||Risk Difference (RD)|22.44|STANDARD_ERROR_OF_MEAN|9.54||0.019|TWO_SIDED|95.0|3.74|41.13|||Normal approximation for two proportions|||Week 4||41.13|3.74|0.019
72388175|NCT01786668|144284400|SUPERIORITY_OR_OTHER||Risk Difference (RD)|14.74|STANDARD_ERROR_OF_MEAN|9.57||0.123|TWO_SIDED|95.0|-4.01|33.5|||Normal approximation for two proportions|||Week 4||33.50|-4.01|0.123
72388176|NCT01786668|144284400|SUPERIORITY_OR_OTHER||Risk Difference (RD)|14.56|STANDARD_ERROR_OF_MEAN|9.75||0.135|TWO_SIDED|95.0|-4.55|33.66|||Normal approximation for two proportions|||Week 8||33.66|-4.55|0.135
72388177|NCT01786668|144284400|SUPERIORITY_OR_OTHER||Risk Difference (RD)|28.02|STANDARD_ERROR_OF_MEAN|9.36||0.003|TWO_SIDED|95.0|9.68|46.36|||Normal approximation for two proportions|||Week 8||46.36|9.68|0.003
72388178|NCT01786668|144284400|SUPERIORITY_OR_OTHER||Risk Difference (RD)|10.71|STANDARD_ERROR_OF_MEAN|9.79||0.274|TWO_SIDED|95.0|-8.48|29.9|||Normal approximation for two proportions|||Week 8||29.90|-8.48|0.274
72388179|NCT01786668|144284401|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.89|STANDARD_ERROR_OF_MEAN|1.123||0.427|TWO_SIDED|95.0|-3.11|1.32|||ANCOVA|||||1.32|-3.11|0.427
72388180|NCT01786668|144284401|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.35|STANDARD_ERROR_OF_MEAN|1.13||0.039|TWO_SIDED|95.0|-4.58|-0.12|||ANCOVA|||||-0.12|-4.58|0.039
72388181|NCT01786668|144284401|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.74|STANDARD_ERROR_OF_MEAN|1.131||0.016|TWO_SIDED|95.0|-4.97|-0.51|||ANCOVA|||||-0.51|-4.97|0.016
72388182|NCT01786668|144284402|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.0|STANDARD_ERROR_OF_MEAN|1.517||0.05|TWO_SIDED|95.0|-5.99|0.0|||ANCOVA|||||-0.00|-5.99|0.050
72388183|NCT01786668|144284402|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.42|STANDARD_ERROR_OF_MEAN|1.52|<|0.001|TWO_SIDED|95.0|-8.42|-2.42|||ANCOVA|||||-2.42|-8.42|<0.001
72388184|NCT01786668|144284402|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.47|STANDARD_ERROR_OF_MEAN|1.525|<|0.001|TWO_SIDED|95.0|-9.48|-3.46|||ANCOVA|||||-3.46|-9.48|<0.001
72388185|NCT01786668|144284403|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.64|STANDARD_ERROR_OF_MEAN|0.52||0.221|TWO_SIDED|95.0|-1.66|0.39|||ANCOVA|||||0.39|-1.66|0.221
72388186|NCT01786668|144284403|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.8|STANDARD_ERROR_OF_MEAN|0.52|<|0.001|TWO_SIDED|95.0|-2.83|-0.78|||ANCOVA|||||-0.78|-2.83|<0.001
72388187|NCT01786668|144284403|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.71|STANDARD_ERROR_OF_MEAN|0.523||0.001|TWO_SIDED|95.0|-2.75|-0.68|||ANCOVA|||||-0.68|-2.75|0.001
72496342|NCT03653390|144522482|SUPERIORITY||||||<|0.01|||||||ANOVA|The ANOVA was conducted on the change scores from baseline to 6 months.||||||<0.01
72619047|NCT01524705|144768793|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
72619048|NCT01524705|144768794|SUPERIORITY|||||||0.77|||||||Wilcoxon (Mann-Whitney)|||||||0.77
72442248|NCT03725722|144397543|SUPERIORITY||Risk Difference (RD)|35.3|||<|0.0005|TWO_SIDED|95.0|17.5|53.2||Data collected after premature discont. of IMP due to COVID-19 were set to missing Week 8. Data collected after premature discont. of IMP due to reasons unrelated to COVID-19 or due to initiation of rescue med. were imputed as non-responders.|Cochran-Mantel-Haenszel|||The difference in response rates between the active delgocitinib cream doses and delgocitinib cream vehicle was analysed separately for each of the active dose groups using the Cochran-Mantel-Haenszel test stratified by region and disease severity (baseline vIGA-AD score). The null hypothesis of no difference in response rates between the delgocitinib cream active doses and delgocitinib cream vehicle was tested against the 2-sided alternative test that there is a difference||53.2|17.5|<0.0005
72442249|NCT03725722|144397543|SUPERIORITY||Risk Difference (RD)|45.4|||<|0.0001|TWO_SIDED|95.0|28.1|62.8||Data collected after premature discont. of IMP due to COVID-19 were set to missing Week 8. Data collected after premature discont. of IMP due to reasons unrelated to COVID-19 or due to initiation of rescue med. were imputed as non-responders.|Cochran-Mantel-Haenszel|||The difference in response rates between the active delgocitinib cream doses and delgocitinib cream vehicle was analysed separately for each of the active dose groups using the Cochran-Mantel-Haenszel test stratified by region and disease severity (baseline vIGA-AD score). The null hypothesis of no difference in response rates between the delgocitinib cream active doses and delgocitinib cream vehicle was tested against the 2-sided alternative test that there is a difference||62.8|28.1|<0.0001
72496343|NCT03653390|144522482|SUPERIORITY||Mean Difference (Net)|-1.24||||0.11|TWO_SIDED|95.0|-2.71|0.22|||Tukey's HSD test|This test inherently adjusts for multiple comparisons.|Difference is calculated as Wellness Education - EnhanceWellness for Disability|||0.22|-2.71|0.11
72559562|NCT00354835|144649170|SUPERIORITY_OR_OTHER_LEGACY||The incidence of platelet count decrease|0.1216|||||ONE_SIDED|95.0||0.1577||||||Compare incidence of Platelet Count Decreased to historical rate of 0.70 from D9803, which is Randomized Study of VCR, Actinomycin-D, and CPM (VAC) vs. VAC alternating with VCR, Topotecan, and CPM (VTC) for Patients with Intermediate Risk RMS. The 95% one-sided confidence interval for the incidence of platelet count decreased will be calculated and evaluated to see if the interval contains the null rate of 0.70.||0.1577||
72559563|NCT00354835|144649170|SUPERIORITY_OR_OTHER_LEGACY||The incidence of vomiting|0.0405|||||ONE_SIDED|95.0||0.0623||||||Compare incidence of Vomiting to historical rate of 0.15 from D9803, which is Randomized Study of VCR, Actinomycin-D, and CPM (VAC) vs. VAC alternating with VCR, Topotecan, and CPM (VTC) for Patients with Intermediate Risk RMS. The 95% one-sided confidence interval for the incidence of vomiting will be calculated and evaluated to see if the interval contains the null rate of 0.15.||0.0623||
72559564|NCT00354835|144649170|SUPERIORITY_OR_OTHER_LEGACY||The incidence of anemia|0.2798|||||ONE_SIDED|95.0||0.3329||||||Compare incidence of Anemia to historical rate of 0.40 from D9803, which is Randomized Study of VCR, Actinomycin-D, and CPM (VAC) vs. VAC alternating with VCR, Topotecan, and CPM (VTC) for Patients with Intermediate Risk RMS. 95% one-sided confidence interval for the incidence of anemia will be calculated and evaluated to see if the interval contains the null rate of 0.40.||0.3329||
72559565|NCT00354835|144649170|SUPERIORITY_OR_OTHER_LEGACY||The incidence of nausea or hepatopathy|0.0052|||||ONE_SIDED|95.0||0.0137||||||Compare incidence of Nausea or Hepatopathy to historical rate of 0.05 from D9803, which is Randomized Study of VCR, Actinomycin-D, and CPM (VAC) vs. VAC alternating with VCR, Topotecan, and CPM (VTC) for Patients with Intermediate Risk RMS. The 95% one-sided confidence interval for the incidence of nausea or hepatopathy will be calculated and evaluated to see if the interval contains the null rate of 0.05.||0.0137||
72559566|NCT00354835|144649170|SUPERIORITY_OR_OTHER_LEGACY||The incidence of febrile neutropenia|0.0881|||||ONE_SIDED|95.0||0.1216||||||Compare incidence of Febrile Neutropenia to historical rate of 0.50 from D9803, which is Randomized Study of VCR, Actinomycin-D, and CPM (VAC) vs. VAC alternating with VCR, Topotecan, and CPM (VTC) for Patients with Intermediate Risk RMS. The 95% one-sided confidence interval for the incidence of febrile neutropenia will be calculated and evaluated to see if the interval contains the null rate of 0.50.||0.1216||
72559567|NCT00354835|144649170|SUPERIORITY_OR_OTHER_LEGACY||The incidence of platelet count decrease|0.3264|||||ONE_SIDED|95.0||0.3819||||||Compare incidence of Platelet Count Decreased to historical rate of 0.70 from D9803, which is Randomized Study of VCR, Actinomycin-D, and CPM (VAC) vs. VAC alternating with VCR, Topotecan, and CPM (VTC) for Patients with Intermediate Risk RMS. The 95% one-sided confidence interval for the incidence of platelet count decreased will be calculated and evaluated to see if the interval contains the null rate of 0.70.||0.3819||
72559568|NCT00354835|144649170|SUPERIORITY_OR_OTHER_LEGACY||The incidence of vomiting|0.0104|||||ONE_SIDED|95.0||0.0224||||||Compare incidence of Vomiting to historical rate of 0.15 from D9803, which is Randomized Study of VCR, Actinomycin-D, and CPM (VAC) vs. VAC alternating with VCR, Topotecan, and CPM (VTC) for Patients with Intermediate Risk RMS. The 95% one-sided confidence interval for the incidence of vomiting will be calculated and evaluated to see if the interval contains the null rate of 0.15.||0.0224||
72559569|NCT00354835|144649173|SUPERIORITY_OR_OTHER_LEGACY|||||||0.99|TWO_SIDED|95.0|||||Fisher Exact|||The incidences of grade 3 or higher neutropenia, with or without fever between UGT1A1 Genotypes (6/6, 6/7, 7/7) were compared by the Fisher's exact test.||||0.99
72559570|NCT00354835|144649173|SUPERIORITY_OR_OTHER_LEGACY|||||||0.036|TWO_SIDED|95.0|||||Fisher Exact|||The incidences of grade 3 or higher diarrhea between UGT1A1 Genotypes (6/6, 6/7, 7/7) were compared by Fisher's exact test.||||0.036
72559571|NCT01968551|144649178|NON_INFERIORITY_OR_EQUIVALENCE|Null Hypothesis: In Cohort 2, the group switching to E/C/F/TAF + DRV was at least 12% lower than the group remaining on SBR with respect to percentage of participants with HIV-1 RNA \< 50 copies/mL at Week 24. Alternative Hypothesis: In Cohort 2, the group switching to E/C/F/TAF + DRV is less than 12% lower than the group remaining on SBR with respect to the proportion of participants with HIV-1 RNA\<50 copies/mL at Week 24.|Difference in proportion|5.3||||0.23|TWO_SIDED|95.001|-3.4|17.4|||Fisher Exact||Difference in percentages of virologic success and its 95.001% confidence interval (CI) calculation was based on exact method. The exact CI was estimated based on unconditional exact method using 2 inverted 1-sided tests with standardized statistic.|||17.4|-3.4|0.23
72619049|NCT01755156|144768795|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.55|||<|0.001|TWO_SIDED|95.0|-0.75|-0.34|||cLDA|Based on a cLDA method with a restriction of the same baseline mean.||||-0.34|-0.75|<0.001
72496344|NCT03653390|144522482|SUPERIORITY||Mean Difference (Net)|-2.4|||<|0.01|TWO_SIDED|95.0|-3.85|-0.95|||Tukey's HSD test|This test inherently adjusts for multiple comparisons.|Difference is calculated as Control - EnhanceWellness for Disability|||-0.95|-3.85|<0.01
72559572|NCT01968551|144649179|NON_INFERIORITY_OR_EQUIVALENCE|Null Hypothesis: In Cohort 2, the group switching to E/C/F/TAF + DRV was at least 12% lower than the group remaining on SBR with respect to percentage of participants with HIV-1 RNA \< 50 copies/mL at Week 48. Alternative Hypothesis: In Cohort 2, the group switching to E/C/F/TAF + DRV is less than 12% lower than the group remaining on SBR with respect to the proportion of participants with HIV-1 RNA \< 50 copies/mL at Week 48.|Difference in proportion|18.3||||0.004|TWO_SIDED|95.001|3.5|33.0|||Fisher Exact||Difference in percentages of virologic success and its 95.001% CI were calculated based on exact method. The exact CI was estimated based on unconditional exact method using 2 inverted 1-sided tests with the standardized statistic.|||33.0|3.5|0.004
72559573|NCT00431041|144649182|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Chi-squared|||||||<0.0001
72559574|NCT00431041|144649183|SUPERIORITY_OR_OTHER|||||||0.001||95.0||||P-value represents overall comparison of severity of dry mouth.|Chi-squared|||||||0.0010
72559575|NCT00573313|144649187|SUPERIORITY_OR_OTHER||Ratio of Geometric Means at 24 weeks.|0.1505|STANDARD_ERROR_OF_MEAN|0.1615||0.36|TWO_SIDED|95.0|-0.1853|0.4863||The data provided here are for changes in serum AST levels as representative of all clinical laboratory parameters measured.|ANCOVA|Analysis of covariance controlled for baseline data, e.g. AST.|Obtained median values and ranges and log transformations of SD.|Power calculation indicated that a sample size of 20 subjects per treatment arm would detect differences between groups of 0.9 within-subject standard deviations or higher at 80% power and 5% level of significance.||0.4863|-0.1853|0.36
72559576|NCT01597791|144649195|SUPERIORITY|||||||0.05||||||Calculated.|Fisher Exact|||||||.05
72559577|NCT02096705|144649214|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9|STANDARD_ERROR_OF_MEAN|0.0968|<|0.0001|TWO_SIDED|95.0|-1.09|-0.71||P-value for Dapagliflozin vs. placebo|Longitudinal repeated measure analysis||Difference of Dapagliflozin from placebo|||-0.71|-1.09|<0.0001
72559578|NCT02096705|144649215|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-30.69|STANDARD_ERROR_OF_MEAN|4.605|<|0.0001|TWO_SIDED|95.0|-39.76|-21.61|||Longitudinal repeated measure analysis|P-value for Dapagliflozin vs. placebo|Difference of Dapagliflozin from placebo|||-21.61|-39.76|<0.0001
72559579|NCT02096705|144649216|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.38|STANDARD_ERROR_OF_MEAN|0.3057|<|0.0001|TWO_SIDED|95.0|-1.98|-0.77||P-value for Dapagliflozin vs. placebo|Longitudinal repeated measure analysis||Difference of Dapagliflozin from placebo|||-0.77|-1.98|<0.0001
72559580|NCT02096705|144649217|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.43|STANDARD_ERROR_OF_MEAN|0.5171||0.0059|TWO_SIDED|95.0|-2.45|-0.42||P-value for Dapagliflozin vs. placebo|Longitudinal repeated measure analysis||Difference of Dapagliflozin from placebo|||-0.42|-2.45|0.0059
72388188|NCT01786668|144284404|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-2.22|STANDARD_ERROR_OF_MEAN|6.95||0.749|TWO_SIDED|95.0|-15.85|11.4|||Normal approximation for two proportions|||Week 2||11.40|-15.85|0.749
72388189|NCT01786668|144284404|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-2.22|STANDARD_ERROR_OF_MEAN|6.95||0.749|TWO_SIDED|95.0|-15.85|11.4|||Normal approximation for two proportions|||Week 2||11.40|-15.85|0.749
72388190|NCT01786668|144284404|SUPERIORITY_OR_OTHER||Risk Difference (RD)|1.62|STANDARD_ERROR_OF_MEAN|7.31||0.824|TWO_SIDED|95.0|-12.71|15.95|||Normal approximation for two proportions|||Week 2||15.95|-12.71|0.824
72388191|NCT01786668|144284404|SUPERIORITY_OR_OTHER||Risk Difference (RD)|13.16|STANDARD_ERROR_OF_MEAN|8.09||0.104|TWO_SIDED|95.0|-2.69|29.01|||Normal approximation for two proportions|||Week 4||29.01|-2.69|0.104
72559581|NCT03277248|144649218|SUPERIORITY||Rate Ratio (Ublituximab / Teriflunomide)|0.509||||0.0022|TWO_SIDED|95.0|0.33|0.784||GEE (Generalized Estimating Equation) model for the relapse count per participant with logarithmic link function, treatment, region, and baseline Expanded Disability Status Scale (EDSS) strata as covariates and log (years of treatment) as offset.|Negative Binomial Model|||||0.784|0.330|0.0022
72559582|NCT03277248|144649219|SUPERIORITY||Rate Ratio (Ublituximab / Teriflunomide)|0.035|||<|0.0001|TWO_SIDED|95.0|0.019|0.064||GEE model for the relapse count per participant with logarithmic link function, treatment, region, and baseline EDSS strata as covariates and log (years of treatment) as offset.|Negative Binomial Model|||||0.064|0.019|<.0001
72559583|NCT03277248|144649220|SUPERIORITY||Rate Ratio (Ublituximab / Teriflunomide)|0.1|||<|0.0001|TWO_SIDED|95.0|0.073|0.136||GEE model for the relapse count per participant with logarithmic link function, treatment, region, and baseline EDSS strata as covariates and log (years of treatment) as offset.|Negative Binomial Model|||||0.136|0.073|<.0001
72559584|NCT03277248|144649222|SUPERIORITY||Odds Ratio (Ublituximab / Teriflunomide)|7.946|||<|0.0001|TWO_SIDED|95.0|4.917|12.841||Logistic regression model with treatment, region, baseline EDSS strata and log transformed baseline MRI lesion counts (T1-unenhancing, T2, Gd-enhancing) as covariates.|Regression, Logistic|||||12.841|4.917|<.0001
72559585|NCT03277248|144649223|SUPERIORITY||Odds Ratio (Ublituximab / Teriflunomide)|0.862||||0.429|TWO_SIDED|95.0|0.596|1.246||Logistic regression model with treatment, region, baseline EDSS strata and log transformed baseline MRI lesion counts (T1 unenhancing, T2, Gd enhancing) as covariates.|Regression, Logistic|||||1.246|0.596|0.4290
72559586|NCT03277248|144649224|SUPERIORITY||Least Squares Mean Difference|-0.018||||0.3108|TWO_SIDED|95.0|-0.053|0.017||Mixed model repeated measures (MMRM) model includes treatment, region, baseline EDSS strata, visit, treatment-by-visit interaction, and baseline volume (cube root transformed) as covariates and an unstructured covariance matrix.|Mixed Model Repeated Measures|||||0.017|-0.053|0.3108
72559587|NCT02235870|144649226|SUPERIORITY||Least-Square Mean Difference|3.28||||0.0261|TWO_SIDED|95.0|2.24|4.32|||ANCOVA|||||4.32|2.24|0.0261
72559588|NCT02235870|144649227|SUPERIORITY||Exact Confidence Interval|64.9|||<|0.0001|TWO_SIDED|95.0|57.5|71.7|||Exact Test|||Subjects in the Obalon Treatment group with at least 2 Balloons and balloon therapy for at least 18 weeks.||71.7|57.5|<0.0001
72559589|NCT02235870|144649228|SUPERIORITY||Percentage Difference|32.8|||<|0.0001|TWO_SIDED|95.0|23.1|42.5|||Chi-squared|||||42.5|23.1|<0.0001
72559590|NCT02670551|144649247|SUPERIORITY||Least Squares Mean Difference|-2.5||||0.0331|TWO_SIDED|95.0|-4.6|-0.4||MMRM analysis was used. Fixed factors: treatment group, pooled study center, visit, treatment-group-by-visit interaction. Covariates: Baseline value, baseline value-by-visit interaction. P-value was adjusted by matched parallel gatekeeping procedure.|Mixed Model Repeated Measures (MMRM)|||To control the overall type I error rate for multiple comparisons of 2 active doses versus placebo at Week 6 for the primary and secondary efficacy parameters, the parallel gatekeeping procedure was implemented.||-0.4|-4.6|0.0331
72559591|NCT02670551|144649247|SUPERIORITY||Least Squares Mean Difference|-3.0||||0.0103|TWO_SIDED|95.0|-5.1|-0.9||MMRM analysis was used. Fixed factors: treatment group, pooled study center, visit, treatment-group-by-visit interaction. Covariates: Baseline value, baseline value-by-visit interaction. P-value was adjusted by matched parallel gatekeeping procedure.|Mixed Model Repeated Measures (MMRM)|||To control the overall type I error rate for multiple comparisons of 2 active doses versus placebo at Week 6 for the primary and secondary efficacy parameters, the parallel gatekeeping procedure was implemented.||-0.9|-5.1|0.0103
72559592|NCT02670551|144649248|SUPERIORITY||Least Squares Mean Difference|-0.2||||0.0714|TWO_SIDED|95.0|-0.5|0.0||MMRM analysis was used. Fixed factors: treatment group, pooled study center, visit, treatment-group-by-visit interaction. Covariates: Baseline value, baseline value-by-visit interaction. P-value was adjusted by matched parallel gatekeeping procedure.|Mixed Model Repeated Measures (MMRM)|||To control the overall type I error rate for multiple comparisons of 2 active doses versus placebo at Week 6 for the primary and secondary efficacy parameters, the parallel gatekeeping procedure was implemented.||0.0|-0.5|0.0714
72559593|NCT02670551|144649248|SUPERIORITY||Least Squares Mean Difference|-0.3||||0.0662|TWO_SIDED|95.0|-0.5|0.0||MMRM analysis was used. Fixed factors: treatment group, pooled study center, visit, treatment-group-by-visit interaction. Covariates: Baseline value, baseline value-by-visit interaction. P-value was adjusted by matched parallel gatekeeping procedure.|Mixed Model Repeated Measures (MMRM)|||To control the overall type I error rate for multiple comparisons of 2 active doses versus placebo at Week 6 for the primary and secondary efficacy parameters, the parallel gatekeeping procedure was implemented.||-0.0|-0.5|0.0662
72559594|NCT04476277|144649260|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
72559595|NCT04476277|144649262|OTHER|||||||0.28|||||||t-test, 2 sided|||||||0.28
72559596|NCT04476277|144649263|OTHER|||||||0.04|||||||t-test, 2 sided|||||||0.04
72559597|NCT04476277|144649264|OTHER|||||||0.01|||||||t-test, 2 sided|||||||0.01
72559598|NCT04476277|144649265|OTHER|||||||0.01|||||||t-test, 2 sided|||||||0.01
72559599|NCT04476277|144649266|OTHER|||||||0.65|||||||t-test, 2 sided|||||||0.65
72559600|NCT04476277|144649267|OTHER|||||||0.48|||||||t-test, 2 sided|||||||0.48
72559601|NCT04476277|144649268|OTHER|||||||0.99|||||||t-test, 2 sided|||||||0.99
72559602|NCT04476277|144649269|OTHER|||||||0.39|||||||t-test, 2 sided|||||||0.39
72559603|NCT04476277|144649270|OTHER|||||||0.43|||||||t-test, 2 sided|||||||0.43
72559604|NCT04476277|144649271|OTHER||||||<|0.01|||||||t-test, 2 sided|||||||<0.01
72559605|NCT04476277|144649272|OTHER|||||||0.01|||||||t-test, 1 sided|||||||0.01
72559606|NCT04476277|144649273|OTHER|||||||0.04|||||||t-test, 2 sided|||||||0.04
72619050|NCT01755156|144768796|SUPERIORITY_OR_OTHER||Difference in %|0.5|||||TWO_SIDED|95.0|-8.8|9.8|||||Based on Miettinen \& Nurminen method. The 95% CI was computed only for those endpoints with at least 4 participants having events in 1 or more treatment groups.|||9.8|-8.8|
72619051|NCT01755156|144768797|SUPERIORITY_OR_OTHER||Difference in %|-2.5|||||TWO_SIDED|95.0|-6.6|1.1|||||Based on Miettinen \& Nurminen method. The 95% CI was computed only for those endpoints with at least 4 participants having events in 1 or more treatment groups.|||1.1|-6.6|
72388192|NCT01786668|144284404|SUPERIORITY_OR_OTHER||Risk Difference (RD)|17.01|STANDARD_ERROR_OF_MEAN|8.26||0.04|TWO_SIDED|95.0|0.81|33.2|||Normal approximation for two proportions|||Week 4||33.20|0.81|0.040
72388193|NCT01786668|144284404|SUPERIORITY_OR_OTHER||Risk Difference (RD)|5.47|STANDARD_ERROR_OF_MEAN|7.62||0.473|TWO_SIDED|95.0|-9.46|20.4|||Normal approximation for two proportions|||Week 4||20.40|-9.46|0.473
72559607|NCT02597049|144649317|SUPERIORITY||Mean Difference (Final Values)|-0.79|||<|0.001|TWO_SIDED|95.0|-0.97|-0.61|||Mixed Models Analysis|||||-0.61|-0.97|<.001
72559608|NCT02597049|144649317|SUPERIORITY||Mean Difference (Final Values)|-0.66|||<|0.001|TWO_SIDED|95.0|-0.84|-0.49|||Mixed Models Analysis|||||-0.49|-0.84|< .001
72559609|NCT02597049|144649318|SUPERIORITY||Mean Difference (Final Values)|-0.82|||<|0.001|TWO_SIDED|95.0|-1.0|-0.64|||Mixed Models Analysis|||||-0.64|-1.00|<.001
72559610|NCT02597049|144649318|SUPERIORITY||Mean Difference (Final Values)|-0.69|||<|0.001|TWO_SIDED|95.0|-0.86|-0.51|||Mixed Models Analysis|||||-0.51|-0.86|<.001
72559611|NCT02597049|144649319|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|||Treatment-regimen Estimand||||< .001
72559612|NCT02597049|144649319|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|||Treatment-regimen Estimand||||< .001
72559613|NCT02597049|144649319|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|||Efficacy Estimand||||< .001
72559614|NCT02597049|144649319|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|||Efficacy Estimand||||< .001
72559615|NCT02597049|144649320|SUPERIORITY||Mean Difference (Final Values)|-0.9||||0.027|TWO_SIDED|95.0|-1.8|-0.1|||Mixed Models Analysis|||Treatment-regimen Estimand||-0.1|-1.8|0.027
72559616|NCT02597049|144649320|SUPERIORITY||Mean Difference (Final Values)|-0.5||||0.264|TWO_SIDED|95.0|-1.3|0.4|||Mixed Models Analysis|||Treatment-regimen Estimand||0.4|-1.3|0.264
72559617|NCT02597049|144649320|SUPERIORITY||Mean Difference (Final Values)|-0.8||||0.059|TWO_SIDED|95.0|-1.7|0.0|||Mixed Models Analysis|||Efficacy Estimand||0.0|-1.7|0.059
72559618|NCT02597049|144649320|SUPERIORITY||Mean Difference (Final Values)|-0.3||||0.435|TWO_SIDED|95.0|-1.2|0.5|||Mixed Models Analysis|||Efficacy Estimand||0.5|-1.2|0.435
72559619|NCT02597049|144649321|SUPERIORITY||Mean Difference (Final Values)|-24.7|||<|0.001|TWO_SIDED|95.0|-30.8|-18.6|||ANCOVA|||Treatment-regimen Estimand||-18.6|-30.8|< .001
72559620|NCT02597049|144649321|SUPERIORITY||Mean Difference (Final Values)|-19.6|||<|0.001|TWO_SIDED|95.0|-25.7|-13.5||Test was not controlled for type I error.|ANCOVA|||Treatment-regimen Estimand||-13.5|-25.7|<0.001
72559621|NCT02597049|144649321|SUPERIORITY||Mean Difference (Final Values)|-26.6|||<|0.001|TWO_SIDED|95.0|-32.7|-20.6||Test was not controlled for type I error.|ANCOVA|||Efficacy Estimand||-20.6|-32.7|<0.001
72559622|NCT02597049|144649321|SUPERIORITY||Mean Difference (Final Values)|-20.7|||<|0.001|TWO_SIDED|95.0|-26.7|-14.6||Test was not controlled for type I error.|ANCOVA|||Efficacy Estimand||-14.6|-26.7|<0.001
72559623|NCT02597049|144649322|SUPERIORITY||Mean Difference (Final Values)|-19.7|||<|0.001|TWO_SIDED|95.0|-25.7|-13.8|||Mixed Models Analysis|||Pre-morning meal.||-13.8|-25.7|< .001
72559624|NCT02597049|144649322|SUPERIORITY||Mean Difference (Final Values)|-15.2|||<|0.001|TWO_SIDED|95.0|-21.2|-9.2|||Mixed Models Analysis|||Pre-morning meal||-9.2|-21.2|< .001
72559625|NCT02597049|144649322|SUPERIORITY||Mean Difference (Final Values)|-24.5|||<|0.001|TWO_SIDED|95.0|-33.8|-15.3|||Mixed Models Analysis|||2-hour postprandial||-15.3|-33.8|< .001
72559626|NCT02597049|144649322|SUPERIORITY||Mean Difference (Final Values)|-21.1|||<|0.001|TWO_SIDED|95.0|-30.3|-11.8|||Mixed Models Analysis|||2-hour postprandial||-11.8|-30.3|< .001
72388194|NCT01786668|144284404|SUPERIORITY_OR_OTHER||Risk Difference (RD)|1.4|STANDARD_ERROR_OF_MEAN|8.86||0.875|TWO_SIDED|95.0|-15.97|18.76|||Normal approximation for two proportions|||Week 8||18.76|-15.97|0.875
72388195|NCT01786668|144284404|SUPERIORITY_OR_OTHER||Risk Difference (RD)|7.16|STANDARD_ERROR_OF_MEAN|9.09||0.43|TWO_SIDED|95.0|-10.65|24.97|||Normal approximation for two proportions|||Week 8||24.97|-10.65|0.430
72388196|NCT01786668|144284404|SUPERIORITY_OR_OTHER||Risk Difference (RD)|9.09|STANDARD_ERROR_OF_MEAN|9.15||0.32|TWO_SIDED|95.0|-8.84|27.01|||Normal approximation for two proportions|||Week 8||27.01|-8.84|0.320
72388197|NCT01786668|144284404|SUPERIORITY_OR_OTHER||Risk Difference (RD)|22.7|STANDARD_ERROR_OF_MEAN|8.82||0.01|TWO_SIDED|95.0|5.41|39.99|||Normal approximation for two proportions|||Week 12||39.99|5.41|0.010
72388198|NCT01786668|144284404|SUPERIORITY_OR_OTHER||Risk Difference (RD)|26.55|STANDARD_ERROR_OF_MEAN|8.87||0.003|TWO_SIDED|95.0|9.16|43.93|||Normal approximation for two proportions|||Week 12||43.93|9.16|0.003
72388199|NCT01786668|144284404|SUPERIORITY_OR_OTHER||Risk Difference (RD)|18.85|STANDARD_ERROR_OF_MEAN|8.74||0.031|TWO_SIDED|95.0|1.72|35.99|||Normal approximation for two proportions|||Week 12||35.99|1.72|0.031
72388200|NCT01786668|144284405|SUPERIORITY_OR_OTHER||Risk Difference (RD)|15.23|STANDARD_ERROR_OF_MEAN|6.95||0.028|TWO_SIDED|95.0|1.61|28.86|||Normal approximation for two proportions|||Week 2||28.86|1.61|0.028
72388201|NCT01786668|144284405|SUPERIORITY_OR_OTHER||Risk Difference (RD)|5.62|STANDARD_ERROR_OF_MEAN|6.05||0.353|TWO_SIDED|95.0|-6.23|17.47|||Normal approximation for two proportions|||Week 2||17.47|-6.23|0.353
72388202|NCT01786668|144284405|SUPERIORITY_OR_OTHER||Risk Difference (RD)|13.31|STANDARD_ERROR_OF_MEAN|6.8||0.05|TWO_SIDED|95.0|-0.02|26.64|||Normal approximation for two proportions|||Week 2||26.64|-0.02|0.050
72442250|NCT03725722|144397544|OTHER|Treatment groups were compared using a 2-sided log-rank test stratified by region and baseline vIGA-AD score. An event was defined as the first time achieving vIGA-AD.|||||>|0.05||||||The statistical test was not controlled for multiplicity.|Log Rank|||Time to vIGA-AD TS was def. as time from date of first IMP applic. to first assess. of vIGA-AD TS. Subjects without baseline observation were censored at date of first IMP applic. Subjects with baseline observation not achieving vIGA-AD TS during treatment period were censored at date of last visit with a valid post-baseline assess. on or prior to date of discont. of IMP or initiation of rescue med, whichever occurred first. Subjects affected by COVID-19 pandemic were handled in the same manner.||||>0.05
72496345|NCT03653390|144522482|SUPERIORITY||Mean Difference (Net)|-1.16||||0.16|TWO_SIDED|95.0|-2.64|0.32|||Tukey's HSD test|This test inherently adjusts for multiple comparisons.|Difference is calculated as Control - Wellness Education|||0.32|-2.64|0.16
72496346|NCT03653390|144522483|SUPERIORITY||||||<|0.01|||||||ANOVA|The ANOVA was conducted on the change scores from baseline to 6 months.||||||<0.01
72559627|NCT02597049|144649322|SUPERIORITY||Mean Difference (Final Values)|-18.3|||<|0.001|TWO_SIDED|95.0|-26.4|-10.2|||Mixed Models Analysis|||Pre-midday meal||-10.2|-26.4|< .001
72559628|NCT02597049|144649322|SUPERIORITY||Mean Difference (Final Values)|-14.3|||<|0.001|TWO_SIDED|95.0|-22.5|-6.2|||Mixed Models Analysis|||Pre-midday meal||-6.2|-22.5|< .001
72559629|NCT02597049|144649322|SUPERIORITY||Mean Difference (Final Values)|-19.0|||<|0.001|TWO_SIDED|95.0|-28.8|-9.3|||Mixed Models Analysis|||2-hour postprandial after midday meal||-9.3|-28.8|< .001
72559630|NCT02597049|144649322|SUPERIORITY||Mean Difference (Final Values)|-12.8||||0.01|TWO_SIDED|95.0|-22.5|-3.1|||Mixed Models Analysis|||2-hour postprandial after midday meal||-3.1|-22.5|0.010
72388203|NCT01786668|144284405|SUPERIORITY_OR_OTHER||Risk Difference (RD)|11.39|STANDARD_ERROR_OF_MEAN|6.64||0.086|TWO_SIDED|95.0|-1.62|24.39|||Normal approximation for two proportions|||Week 4||24.39|-1.62|0.086
72388204|NCT01786668|144284405|SUPERIORITY_OR_OTHER||Risk Difference (RD)|22.93|STANDARD_ERROR_OF_MEAN|7.43||0.002|TWO_SIDED|95.0|8.37|37.48|||Normal approximation for two proportions|||Week 4||37.48|8.37|0.002
72388205|NCT01786668|144284405|SUPERIORITY_OR_OTHER||Risk Difference (RD)|21.0|STANDARD_ERROR_OF_MEAN|7.32||0.004|TWO_SIDED|95.0|6.65|35.36|||Normal approximation for two proportions|||Week 4||35.36|6.65|0.004
72388206|NCT01786668|144284405|SUPERIORITY_OR_OTHER||Risk Difference (RD)|11.35|STANDARD_ERROR_OF_MEAN|7.03||0.106|TWO_SIDED|95.0|-2.43|25.13|||Normal approximation for two proportions|||Week 8||25.13|-2.43|0.106
72388207|NCT01786668|144284405|SUPERIORITY_OR_OTHER||Risk Difference (RD)|32.5|STANDARD_ERROR_OF_MEAN|8.02|<|0.001|TWO_SIDED|95.0|16.79|48.22|||Normal approximation for two proportions|||Week 8||48.22|16.79|<0.001
72388208|NCT01786668|144284405|SUPERIORITY_OR_OTHER||Risk Difference (RD)|19.04|STANDARD_ERROR_OF_MEAN|7.54||0.012|TWO_SIDED|95.0|4.27|33.81|||Normal approximation for two proportions|||Week 8||33.81|4.27|0.012
72388209|NCT01786668|144284405|SUPERIORITY_OR_OTHER||Risk Difference (RD)|3.54|STANDARD_ERROR_OF_MEAN|7.47||0.635|TWO_SIDED|95.0|-11.1|18.19|||Normal approximation for two proportions|||Week 12||18.19|-11.10|0.635
72388210|NCT01786668|144284405|SUPERIORITY_OR_OTHER||Risk Difference (RD)|34.31|STANDARD_ERROR_OF_MEAN|8.6|<|0.001|TWO_SIDED|95.0|17.45|51.18|||Normal approximation for two proportions|||Week 12||51.18|17.45|<0.001
72388211|NCT01786668|144284405|SUPERIORITY_OR_OTHER||Risk Difference (RD)|22.78|STANDARD_ERROR_OF_MEAN|8.45||0.007|TWO_SIDED|95.0|6.21|39.34|||Normal approximation for two proportions|||Week 12||39.34|6.21|0.007
72388212|NCT01786668|144284406|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.19|STANDARD_ERROR_OF_MEAN|0.136||0.175|TWO_SIDED|95.0|-0.46|0.08|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 2||0.08|-0.46|0.175
72388213|NCT01786668|144284406|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.51|STANDARD_ERROR_OF_MEAN|0.136|<|0.001|TWO_SIDED|95.0|-0.77|-0.24|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 2||-0.24|-0.77|<0.001
72496347|NCT03653390|144522483|SUPERIORITY||Mean Difference (Net)|-2.18||||0.018|TWO_SIDED|95.0|-4.05|-0.3||This test inherently adjusts for multiple comparisons.|Tukey's HSD test||Difference is calculated as Wellness Education - EnhanceWellness for Disability|||-0.30|-4.05|0.018
72496348|NCT03653390|144522483|SUPERIORITY||Mean Difference (Net)|-2.26||||0.012|TWO_SIDED|95.0|-4.12|-0.41||This test inherently adjusts for multiple comparisons.|Tukey's HSD test||Difference is calculated as Control - EnhanceWellness for Disability|||-0.41|-4.12|0.012
72559631|NCT02597049|144649322|SUPERIORITY||Mean Difference (Final Values)|-22.7|||<|0.001|TWO_SIDED|95.0|-30.7|-14.7|||Mixed Models Analysis|||Pre-evening meal||-14.7|-30.7|< .001
72442251|NCT03725722|144397544|OTHER|Treatment groups were compared using a 2-sided log-rank test stratified by region and baseline vIGA-AD score. An event was defined as the first time achieving vIGA-AD.|||||>|0.05||||||"vIGA-AD was reached in less than 50% of participants, therefore the median time was not estimable.~The statistical test was not controlled for multiplicity."|Log Rank|||Time to vIGA-AD TS was def. as time from date of first IMP applic. to first assess. of vIGA-AD TS. Subjects without baseline observation were censored at date of first IMP applic. Subjects with baseline observation not achieving vIGA-AD TS during treatment period were censored at date of last visit with a valid post-baseline assess. on or prior to date of discont. of IMP or initiation of rescue med, whichever occurred first. Subjects affected by COVID-19 pandemic were handled in the same manner.||||>0.05
72442252|NCT03725722|144397544|OTHER|Treatment groups were compared using a 2-sided log-rank test stratified by region and baseline vIGA-AD score. An event was defined as the first time achieving vIGA-AD.|||||>|0.05||||||The statistical test was not controlled for multiplicity|Log Rank|||Time to vIGA-AD TS was def. as time from date of first IMP applic. to first assess. of vIGA-AD TS. Subjects without baseline observation were censored at date of first IMP applic. Subjects with baseline observation not achieving vIGA-AD TS during treatment period were censored at date of last visit with a valid post-baseline assess. on or prior to date of discont. of IMP or initiation of rescue med, whichever occurred first. Subjects affected by COVID-19 pandemic were handled in the same manner||||>0.05
72442253|NCT03725722|144397544|OTHER|Treatment groups were compared using a 2-sided log-rank test stratified by region and baseline vIGA-AD score. An event was defined as the first time achieving vIGA-AD|||||<|0.001||||||The statistical test was not controlled for multiplicity|Log Rank|||Time to vIGA-AD TS was def. as time from date of first IMP applic. to first assess. of vIGA-AD TS. Subjects without baseline observation were censored at date of first IMP applic. Subjects with baseline observation not achieving vIGA-AD TS during treatment period were censored at date of last visit with a valid post-baseline assess. on or prior to date of discont. of IMP or initiation of rescue med, whichever occurred first. Subjects affected by COVID-19 pandemic were handled in the same manner||||<0.001
72442254|NCT01600014|144397545|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|2.44||||0.001|TWO_SIDED|95.0|1.32|4.51||Chi-square test for stratified data with a significance level of 5%. No adjustment for multiple tests was needed, due to the analyses were based on distinct subject groups|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel ratio of clearance rates (Ingenol mebutate relative to Vehicle) adjusted for anatomical location and country||The analysis type was superiority between groups. In total 141 subjects were included||4.51|1.32|0.001
72442255|NCT01600014|144397545|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|2.37||||0.013|TWO_SIDED|95.0|1.07|5.25||Chi-square test for stratified data with a significance level of 5%. No adjustment for multiple tests was needed, due to the analyses were based on distinct subject groups|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel ratio of clearance rates (Ingenol mebutate relative to Vehicle) adjusted for anatomical location and week of randomisation||The analysis type was superiority between groups. In total 62 subjects were included||5.25|1.07|0.013
72442256|NCT01600014|144397546|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|4.41||||0.016|TWO_SIDED|95.0|1.1|17.62||A closed test procedure was chosen where the evaluation process stopped when the first non-significant results were observed thus securing that the overall significance level did not exceed 5% for multiple testing|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel ratio of clearance rates (Ingenol mebutate relative to Vehicle) adjusted for anatomical location and country||The analysis type was superiority between groups. In total 141 subjects were included||17.62|1.10|0.016
72442257|NCT01600014|144397546|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|2.24||||0.1|TWO_SIDED|95.0|0.78|6.47||A closed test procedure was chosen where the evaluation process stopped when the first non-significant results were observed thus securing that the overall significance level did not exceed 5% for multiple testing|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel ratio of clearance rates (Ingenol mebutate relative to Vehicle) adjusted for anatomical location and country||The analysis type was superiority between groups. In total 62 subjects were included||6.47|0.78|0.10
72442258|NCT01600014|144397546|SUPERIORITY_OR_OTHER_LEGACY||Percent cleared subjects|50.0|||||TWO_SIDED|95.0|44.0|56.1|||||Estimation based on completers only.|Subjects randomised to vehicle were not included in the estimate of the overall clearance rate for the repeat-use regimen, from last treatment throught to Month 12. Instead, the subjects randomised to ingenol mebutate were given higher weights to reflect the hypothetical scenario where all randomised subjects were given active treatment during the repeat use cycle||56.1|44.0|
72442259|NCT01600014|144397547|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.88|||<|0.001|TWO_SIDED|95.0|-1.38|-0.38||A closed test procedure was chosen where the evaluation process stopped when the first non-significant results were observed thus securing that the overall significance level did not exceed 5% for multiple testing|ANCOVA|Analysed using ANCOVA adjusted for anatomical location, country and AK count at randomisation|Using baseline observation carried forward (BOCF) as the imputation method.|The analysis type was superiority between groups. In total 141 subjects were included||-0.38|-1.38|<0.001
72559632|NCT02597049|144649322|SUPERIORITY||Mean Difference (Final Values)|-22.5|||<|0.001|TWO_SIDED|95.0|-30.7|-14.4|||Mixed Models Analysis|||Pre-evening meal||-14.4|-30.7|< .001
72559633|NCT02597049|144649322|SUPERIORITY||Mean Difference (Final Values)|-22.1|||<|0.001|TWO_SIDED|95.0|-31.4|-12.9|||Mixed Models Analysis|||2-hour postprandial after evening meal||-12.9|-31.4|< .001
72559634|NCT02597049|144649322|SUPERIORITY||Mean Difference (Final Values)|-16.7|||<|0.001|TWO_SIDED|95.0|-26.0|-7.4|||Mixed Models Analysis|||2-hour postprandial after evening meal||-7.4|-26.0|< .001
72559635|NCT02597049|144649323|SUPERIORITY||Mean Difference (Final Values)|-1.2||||0.032|TWO_SIDED|95.0|-2.3|-0.1|||ANCOVA|||Treatment-regimen Estimand||-0.1|-2.3|0.032
72559636|NCT02597049|144649323|SUPERIORITY||Mean Difference (Final Values)|-0.6||||0.273|TWO_SIDED|95.0|-1.7|0.5|||ANCOVA|||Treatment-regimen Estimand||0.5|-1.7|0.273
72559637|NCT02597049|144649323|SUPERIORITY||Mean Difference (Final Values)|-1.3||||0.023|TWO_SIDED|95.0|-2.4|-0.2|||ANCOVA|||Efficacy Estimand||-0.2|-2.4|0.023
72559638|NCT02597049|144649323|SUPERIORITY||Mean Difference (Final Values)|-0.6||||0.32|TWO_SIDED|95.0|-1.7|0.6|||ANCOVA|||Efficacy Estimand||0.6|-1.7|0.320
72559639|NCT02463487|144649328|OTHER|||||||0.87|||||||t-test, 1 sided|||||||0.87
72559640|NCT02463487|144649330|OTHER|||||||0.08|||||||t-test, 2 sided|||||||0.08
72442260|NCT01600014|144397547|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-1.01|||<|0.001|TWO_SIDED|95.0|-1.52|-0.51||A closed test procedure was chosen where the evaluation process stopped when the first non-significant results were observed thus securing that the overall significance level did not exceed 5% for multiple testing|ANCOVA|Sensitivity analysis using complete cases|Sensitivity analysis using complete cases|The analysis type was superiority between groups. In total 141 subjects were included||-0.51|-1.52|<0.001
72442261|NCT01600014|144397547|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.69||||0.008|TWO_SIDED|95.0|-1.19|-0.19||Formal statistical significance could not be established because of the closed test procedure where the first secondary endpoint tested (12 months clearance) did not reach statistical significance in the recurrent subgroup|ANCOVA|Analysed using ANCOVA adjusted for anatomical location, country and AK count at randomisation|Using BOCF as the imputation method, the difference in the adjusted mean AK count between the ingenol mebutate and vehicle groups|The analysis type was superiority between groups. In total 62 subjects were included||-0.19|-1.19|0.008
72442262|NCT05057897|144397600|OTHER|Descriptive only. Analysis conducted at request of clinicaltrials.gov.|GMT Ratio|0.73|||||TWO_SIDED|95.0|0.18|3.01|||||The GMT ratio was calculated as the ratio of the titer levels in the immunocompromised cohort to the immunocompetent cohort.|Day 57 (28 days post Dose 2)||3.01|0.18|
72442263|NCT05057897|144397601|OTHER|Descriptive only. Analysis conducted at request of clinicaltrials.gov.|Difference in Seroresponse|-30.36|||||TWO_SIDED|95.0|-62.82|3.69||||The 2-sided 95% CI was calculated using the Newcombe score without continuity correction.|The difference in seroresponse 28 days post Dose 2 of AZD1222 was calculated as (seroresponse rate of immunocompromised cohort) - (seroresponse rate of immunocompetent cohort).|Day 57 (28 days post Dose 2)||3.69|-62.82|
72442264|NCT05057897|144397602|OTHER|Descriptive only. Analysis conducted at request of clinicaltrials.gov.|GMT Ratio|0.47|||||TWO_SIDED|95.0|0.06|3.86|||||The GMT ratio was calculated as the ratio of the titer levels in the immunocompromised cohort to the immunocompetent cohort.|Day 57 (28 days post Dose 2)||3.86|0.06|
72442265|NCT05057897|144397603|OTHER|Descriptive only. Analysis conducted at request of clinicaltrials.gov.|Difference in Seroresponse|-25.0|||||TWO_SIDED|95.0|-59.07|2.97||||The 2-sided 95% CI was calculated using the Newcombe score without continuity correction.|The difference in seroresponse 28 days post Dose 2 of AZD1222 was calculated as (seroresponse rate of immunocompromised cohort) - (seroresponse rate of immunocompetent cohort).|Day 57 (28 days post Dose 2)||2.97|-59.07|
72496349|NCT03653390|144522483|SUPERIORITY||Mean Difference (Net)|-0.08||||0.99|TWO_SIDED|95.0|-1.98|1.81||This test inherently adjusts for multiple comparisons.|Tukey's HSD test||Difference is calculated as Control - Wellness Education|||1.81|-1.98|0.99
72496350|NCT03653390|144522484|SUPERIORITY|||||||0.382|||||||ANOVA|The ANOVA was conducted on the change scores from baseline to 3 months.||||||0.382
72496351|NCT03653390|144522485|SUPERIORITY|||||||0.29|||||||ANOVA|The ANOVA was conducted on the change scores from baseline to 3 months.||||||0.29
72496352|NCT03653390|144522486|SUPERIORITY|||||||0.057|||||||ANOVA|The ANOVA was conducted on the change scores from baseline to 3 months.||||||0.057
72496353|NCT03653390|144522487|SUPERIORITY|||||||0.21|||||||ANOVA|The ANOVA was conducted on the change in number of trips from baseline to 12 months.||||||0.21
72496354|NCT03653390|144522488|SUPERIORITY|||||||0.79|||||||ANOVA|The ANOVA was conducted on the change in radius of gyration from baseline to 12 months.||||||0.79
72496355|NCT03653390|144522489|SUPERIORITY|||||||0.26|||||||ANOVA|The ANOVA was conducted on the change in number of trips from baseline to 12 months.||||||0.26
72559641|NCT03105297|144649377|SUPERIORITY|||||||0.0147||95.0||||p-value for comparing between treatments (strip/no strip) were computed from mixed models with treatment \& period as fixed effects, participants as random effects \& time as repeated measures effect.|ANCOVA|||||||0.0147
72559642|NCT03105297|144649378|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||p-values are from a one sample t-test using SAS UNIVARIATE on change from baseline.|t-test, 1 sided|||||||<0.0001
72559643|NCT03105297|144649379|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||p-values are from a one sample t-test using SAS UNIVARIATE on change from baseline.|t-test, 1 sided|||||||<0.0001
72442266|NCT05057897|144397604|OTHER|Descriptive only. Analysis conducted at request of clinicaltrials.gov.|GMT Ratio|0.32|||||TWO_SIDED|95.0|0.12|0.8|||||The GMT ratio was calculated as the ratio of the titer levels in the immunocompromised cohort to the immunocompetent cohort.|Day 85 Immunocompromised / Day 211 Immunocompetent (28 days post Dose 3)||0.80|0.12|
72442267|NCT05057897|144397605|OTHER|Descriptive only. Analysis conducted at request of clinicaltrials.gov.|Difference in Seroresponse|0.0||||||||||||Due to everyone in both cohorts being a seroresponder, the confidence interval (CI) around the difference is not estimable.|The difference in seroresponse 28 days post Dose 3 of AZD1222 was calculated as (seroresponse rate of immunocompromised cohort) - (seroresponse rate of immunocompetent cohort).|Day 85 Immunocompromised / Day 211 Immunocompetent (28 days post Dose 3)||||
72496356|NCT03653390|144522490|SUPERIORITY||||||<|0.01|||||||ANOVA|The ANOVA was conducted on the change in minutes from baseline to 12 months.||||||<0.01
72496357|NCT03653390|144522490|SUPERIORITY||Mean Difference (Net)|-28.7||||0.57|TWO_SIDED|95.0|-95.7|38.4||This test inherently adjusts for multiple comparisons.|Tukey's HSD test||Difference is calculated as Wellness Education - EnhanceWellness for Disability|||38.4|-95.7|0.57
72496358|NCT03653390|144522490|SUPERIORITY||Mean Difference (Net)|66.6||||0.048|TWO_SIDED|95.0|0.56|132.6||This test inherently adjusts for multiple comparisons.|Tukey's HSD test||Difference is calculated as Control - EnhanceWellness for Disability|||132.6|0.56|0.048
72496359|NCT03653390|144522490|SUPERIORITY||Mean Difference (Net)|95.3|||<|0.01|TWO_SIDED|95.0|31.8|158.7||This test inherently adjusts for multiple comparisons.|Tukey's HSD test||Difference is calculated as Control - Wellness Education|||158.7|31.8|<0.01
72496360|NCT03653390|144522491|SUPERIORITY||||||<|0.01|||||||ANOVA|The ANOVA was conducted on the change scores from baseline to 12 months.||||||<0.01
72496361|NCT03653390|144522491|SUPERIORITY||Mean Difference (Net)|-1.55||||0.028|TWO_SIDED|95.0|-2.97|-0.13||This test inherently adjusts for multiple comparisons.|Tukey's HSD test||Difference is calculated as Wellness Education - EnhanceWellness for Disability|||-0.13|-2.97|0.028
72496362|NCT03653390|144522491|SUPERIORITY||Mean Difference (Net)|-2.15|||<|0.01|TWO_SIDED|95.0|-3.55|-0.75|||Tukey's HSD test||Difference is calculated as Control - EnhanceWellness for Disability|||-0.75|-3.55|<0.01
72496363|NCT03653390|144522491|SUPERIORITY||Mean Difference (Net)|-0.6||||0.59|TWO_SIDED|95.0|-2.03|0.83||This test inherently adjusts for multiple comparisons.|Tukey's HSD test||Difference is calculated as Control - Wellness Education|||0.83|-2.03|0.59
72559644|NCT03105297|144649380|SUPERIORITY_OR_OTHER|||||||0.0073||95.0||||p-values are from a one sample t-test using SAS (Statistical Analysis System) UNIVARIATE on change from baseline.|t-test, 1 sided|||||||0.0073
72388214|NCT01786668|144284406|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.47|STANDARD_ERROR_OF_MEAN|0.136|<|0.001|TWO_SIDED|95.0|-0.74|-0.2|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 2||-0.20|-0.74|<0.001
72442268|NCT05057897|144397606|OTHER|Descriptive only. Analysis conducted at request of clinicaltrials.gov.|GMT Ratio|0.56|||||TWO_SIDED|95.0|0.25|1.25|||||The GMT ratio was calculated as the ratio of the titer levels in the immunocompromised cohort to the immunocompetent cohort.|Day 85 Immunocompromised / Day 211 Immunocompetent (28 days post Dose 3)||1.25|0.25|
72442269|NCT05057897|144397607|OTHER|Descriptive only. Analysis conducted at request of clinicaltrials.gov.|Difference in Seroresponse|0.0||||||||||||Due to everyone in both cohorts being a seroresponder, the confidence interval (CI) around the difference is not estimable.|The difference in seroresponse 28 days post Dose 3 of AZD1222 was calculated as (seroresponse rate of immunocompromised cohort) - (seroresponse rate of immunocompetent cohort).|Day 85 Immunocompromised / Day 211 Immunocompetent (28 days post Dose 3)||||
72442270|NCT04714320|144397608|SUPERIORITY||||||=|0.135||||||The stratification factor (screening estimated glomerular filtration rate (eGFR) status \[\<60 vs. ≥60 mL/min/1.73 m\^2\]), treatment received, and baseline measure were included in the analysis of covariate (ANCOVA) model as independent variables.|ANCOVA|||Change From Baseline in Seated Automated Office SBP to Day 85||||=0.135
72442271|NCT04714320|144397608|SUPERIORITY||||||=|0.867||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change From Baseline in Seated Automated Office SBP to Day 85||||=0.867
72442272|NCT04714320|144397610|SUPERIORITY||||||<|0.001||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change From Baseline at Day 15||||<0.001
72442273|NCT04714320|144397610|SUPERIORITY||||||<|0.001||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change From Baseline at Day 15||||<0.001
72442274|NCT04714320|144397610|SUPERIORITY||||||<|0.001||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 29||||<0.001
72442275|NCT04714320|144397610|SUPERIORITY||||||<|0.001||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 29||||<0.001
72559645|NCT00714051|144649422|SUPERIORITY_OR_OTHER|||||||0.45|TWO_SIDED||||||Chi-squared|||The number of participants who fell on the tripping trial in each group were compared using Chi-square analysis||||0.45
72619052|NCT01755156|144768798|SUPERIORITY_OR_OTHER||Difference in %|4.5|||||TWO_SIDED|95.0|-3.3|12.3||||||||12.3|-3.3|
72619053|NCT01755156|144768799|SUPERIORITY_OR_OTHER||Difference in %|-14.5||||0.011|TWO_SIDED|95.0|-25.6|-3.4|||cLDA|Based on a cLDA method with a restriction of the same baseline mean.||||-3.4|-25.6|0.011
72388215|NCT01786668|144284406|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.43|STANDARD_ERROR_OF_MEAN|0.141||0.003|TWO_SIDED|95.0|-0.7|-0.15|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 4||-0.15|-0.70|0.003
72442276|NCT04714320|144397610|SUPERIORITY||||||<|0.001||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 43||||<0.001
72442277|NCT04714320|144397610|SUPERIORITY||||||<|0.001||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 43||||<0.001
72442278|NCT04714320|144397610|SUPERIORITY||||||<|0.001||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 57||||<0.001
72442279|NCT04714320|144397610|SUPERIORITY||||||<|0.001||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 57||||<0.001
72442280|NCT04714320|144397610|SUPERIORITY||||||<|0.001||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]) and treatment received were included in the Van Elteren model as independent variables.|Van Elteren|||Change from Baseline at Day 71||||<0.001
72442281|NCT04714320|144397610|SUPERIORITY||||||<|0.001||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]) and treatment received were included in the Van Elteren model as independent variables.|Van Elteren|||Change from Baseline at Day 71||||<0.001
72442282|NCT04714320|144397610|SUPERIORITY||||||<|0.001||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]) and treatment received were included in the Van Elteren model as independent variables.|Van Elteren|||Change from Baseline at Day 85||||<0.001
72442283|NCT04714320|144397610|SUPERIORITY||||||<|0.001||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]) and treatment received were included in the Van Elteren model as independent variables.|Van Elteren|||Change from Baseline at Day 85||||<0.001
72442284|NCT04714320|144397610|SUPERIORITY||||||<|0.001||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 92||||<0.001
72442285|NCT04714320|144397610|SUPERIORITY||||||<|0.001||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 92||||<0.001
72442286|NCT04714320|144397610|SUPERIORITY||||||<|0.001||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]) and treatment received were included in the Van Elteren model as independent variables.|Van Elteren|||Change from Baseline at Day 106||||<0.001
72388216|NCT01786668|144284406|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.62|STANDARD_ERROR_OF_MEAN|0.141|<|0.001|TWO_SIDED|95.0|-0.9|-0.34|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 4||-0.34|-0.90|<0.001
72496364|NCT01552681|144522541|SUPERIORITY_OR_OTHER|||||||0.33|TWO_SIDED|||||P-value is testing for treatment effect using an analysis of covariance with adjustments for screening stimulated salivary flow.|ANCOVA|||Missing Week 24 assessments were imputed by carrying forward the last observed post-baseline value.||||0.33
72496365|NCT02769728|144522563|SUPERIORITY|||||||0.001|||||||Mixed Models Analysis|||The threshold for statistical significance was p = 0.05||||0.001
72496366|NCT02769728|144522564|SUPERIORITY|||||||0.081||||||The threshold for statistical significance was p = 0.05|Friedman test|||||||0.081
72619054|NCT01755156|144768800|SUPERIORITY_OR_OTHER||Difference in least squares means|-9.5||||0.01|TWO_SIDED|95.0|-16.7|-2.3|||cLDA|Based on a cLDA method with a restriction of the same baseline mean.||||-2.3|-16.7|0.010
72388217|NCT01786668|144284406|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.59|STANDARD_ERROR_OF_MEAN|0.141|<|0.001|TWO_SIDED|95.0|-0.86|-0.31|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 4||-0.31|-0.86|<0.001
72388218|NCT01786668|144284406|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.35|STANDARD_ERROR_OF_MEAN|0.158||0.026|TWO_SIDED|95.0|-0.66|-0.04|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 8||-0.04|-0.66|0.026
72388219|NCT01786668|144284406|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.63|STANDARD_ERROR_OF_MEAN|0.157|<|0.001|TWO_SIDED|95.0|-0.94|-0.32|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 8||-0.32|-0.94|<0.001
72388220|NCT01786668|144284406|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.59|STANDARD_ERROR_OF_MEAN|0.159|<|0.001|TWO_SIDED|95.0|-0.9|-0.27|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 8||-0.27|-0.90|<0.001
72388221|NCT01786668|144284406|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.55|STANDARD_ERROR_OF_MEAN|0.171||0.002|TWO_SIDED|95.0|-0.89|-0.21|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 12||-0.21|-0.89|0.002
72388222|NCT01786668|144284406|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.73|STANDARD_ERROR_OF_MEAN|0.171|<|0.001|TWO_SIDED|95.0|-1.07|-0.39|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 12||-0.39|-1.07|<0.001
72388223|NCT01786668|144284406|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.69|STANDARD_ERROR_OF_MEAN|0.172|<|0.001|TWO_SIDED|95.0|-1.03|-0.35|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 12||-0.35|-1.03|<0.001
72388224|NCT01786668|144284407|SUPERIORITY_OR_OTHER||Risk Difference (RD)|11.24|STANDARD_ERROR_OF_MEAN|7.99||0.159|TWO_SIDED|95.0|-4.41|26.89|||Normal approximation for two proportions|||Week 2||26.89|-4.41|0.159
72388225|NCT01786668|144284407|SUPERIORITY_OR_OTHER||Risk Difference (RD)|32.39|STANDARD_ERROR_OF_MEAN|8.6|<|0.001|TWO_SIDED|95.0|15.54|49.24|||Normal approximation for two proportions|||Week 2||49.24|15.54|<0.001
72388226|NCT01786668|144284407|SUPERIORITY_OR_OTHER||Risk Difference (RD)|24.7|STANDARD_ERROR_OF_MEAN|8.5||0.004|TWO_SIDED|95.0|8.04|41.36|||Normal approximation for two proportions|||Week 2||41.36|8.04|0.004
72388227|NCT01786668|144284407|SUPERIORITY_OR_OTHER||Risk Difference (RD)|22.7|STANDARD_ERROR_OF_MEAN|8.82||0.01|TWO_SIDED|95.0|5.41|39.99|||Normal approximation for two proportions|||Week 4||39.99|5.41|0.010
72388228|NCT01786668|144284407|SUPERIORITY_OR_OTHER||Risk Difference (RD)|38.08|STANDARD_ERROR_OF_MEAN|8.82|<|0.001|TWO_SIDED|95.0|20.79|55.38|||Normal approximation for two proportions|||Week 4||55.38|20.79|<0.001
72388229|NCT01786668|144284407|SUPERIORITY_OR_OTHER||Risk Difference (RD)|32.32|STANDARD_ERROR_OF_MEAN|8.88|<|0.001|TWO_SIDED|95.0|14.9|49.73|||Normal approximation for two proportions|||Week 4||49.73|14.90|<0.001
72388230|NCT01786668|144284407|SUPERIORITY_OR_OTHER||Risk Difference (RD)|14.82|STANDARD_ERROR_OF_MEAN|9.39||0.114|TWO_SIDED|95.0|-3.58|33.22|||Normal approximation for two proportions|||Week 8||33.22|-3.58|0.114
72388231|NCT01786668|144284407|SUPERIORITY_OR_OTHER||Risk Difference (RD)|30.2|STANDARD_ERROR_OF_MEAN|9.33||0.001|TWO_SIDED|95.0|11.92|48.49|||Normal approximation for two proportions|||Week 8||48.49|11.92|0.001
72388232|NCT01786668|144284407|SUPERIORITY_OR_OTHER||Risk Difference (RD)|30.2|STANDARD_ERROR_OF_MEAN|9.33||0.001|TWO_SIDED|95.0|11.92|48.49|||Normal approximation for two proportions|||Week 8||48.49|11.92|0.001
72388233|NCT01786668|144284407|SUPERIORITY_OR_OTHER||Risk Difference (RD)|24.47|STANDARD_ERROR_OF_MEAN|9.33||0.009|TWO_SIDED|95.0|6.18|42.76|||Normal approximation for two proportions|||Week 12||42.76|6.18|0.009
72388234|NCT01786668|144284407|SUPERIORITY_OR_OTHER||Risk Difference (RD)|36.01|STANDARD_ERROR_OF_MEAN|9.15|<|0.001|TWO_SIDED|95.0|18.09|53.94|||Normal approximation for two proportions|||Week 12||53.94|18.09|<0.001
72388235|NCT01786668|144284407|SUPERIORITY_OR_OTHER||Risk Difference (RD)|28.32|STANDARD_ERROR_OF_MEAN|9.3||0.002|TWO_SIDED|95.0|10.09|46.55|||Normal approximation for two proportions|||Week 12||46.55|10.09|0.002
72388236|NCT01786668|144284408|SUPERIORITY_OR_OTHER||Risk Difference (RD)|5.73|STANDARD_ERROR_OF_MEAN|4.17||0.17|TWO_SIDED|95.0|-2.45|13.91|||Normal approximation for two proportions|||Week 2||13.91|-2.45|0.170
72388237|NCT01786668|144284408|SUPERIORITY_OR_OTHER||Risk Difference (RD)|5.73|STANDARD_ERROR_OF_MEAN|4.17||0.17|TWO_SIDED|95.0|-2.45|13.91|||Normal approximation for two proportions|||Week 2||13.91|-2.45|0.170
72496367|NCT02769728|144522565|SUPERIORITY|||||||0.114||||||The threshold for statistical significance was p = 0.05|Friedman test|||||||0.114
72496368|NCT02769728|144522566|SUPERIORITY|||||||0.021||||||The threshold for statistical significance was p = 0.05|Friedman test|||||||0.021
72496369|NCT02769728|144522567|SUPERIORITY|||||||1||||||The threshold for statistical significance was p = 0.05|Friedman test|||||||1.00
72559646|NCT03868631|144649423|SUPERIORITY||||||<|0.05|||||||multilevel models for change|||Between-group differences at baseline were compared using independent t-tests. Multilevel models for change (MLM) were used to determine differences between groups over time for study outcomes. Age, sex, and number of sessions missed were included as covariates. Time and time by group interactions were examined. Analyses were conducted using IBM SPSS Statistics version 23. Significance was set at p\<0.05.||||<0.05
72559647|NCT05740098|144649441|SUPERIORITY||Odds Ratio (OR)|5.378|||<|0.001|TWO_SIDED|95.0|2.278|12.689|||Mixed Models Analysis|||Analysis tested for significant main effects of treatment condition on 7-day point prevalence abstinence at 12- and 24-week assessments||12.689|2.278|<0.001
72559648|NCT05740098|144649441|SUPERIORITY||Odds Ratio (OR)|3.668||||0.003|TWO_SIDED|95.0|1.538|8.747|||Mixed Models Analysis|||Analysis tested for significant main effects of treatment condition on 7-day point prevalence abstinence at 12- and 24-week assessments||8.747|1.538|0.003
72559649|NCT05740098|144649441|SUPERIORITY||Odds Ratio (OR)|0.682||||0.256|TWO_SIDED|95.0|0.352|1.321|||Mixed Models Analysis|||Analysis tested for significant main effects of treatment condition on 7-day point prevalence abstinence at 12- and 24-week assessments||1.321|0.352|0.256
72559650|NCT05740098|144649441|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||Analysis tested for significant main effect of time on 7-day point prevalence abstinence at 12- and 24-week assessments||||<0.001
72559651|NCT05740098|144649442|SUPERIORITY||Mean Difference (Final Values)|0.39|STANDARD_ERROR_OF_MEAN|0.365||0.287|TWO_SIDED||||||Mixed Models Analysis|||Analysis tested for significant main effect of treatment condition on Child Urine Cotinine||||0.287
72559652|NCT05740098|144649442|SUPERIORITY||Mean Difference (Final Values)|-0.597|STANDARD_ERROR_OF_MEAN|0.369||0.108|TWO_SIDED||||||Mixed Models Analysis|||Analysis tested for significant main effect of treatment condition on Child Urine Cotinine||||0.108
72559653|NCT05740098|144649442|SUPERIORITY||Mean Difference (Final Values)|-0.987|STANDARD_ERROR_OF_MEAN|0.361||0.007|TWO_SIDED||||||Mixed Models Analysis|||Analysis tested for significant main effect of treatment condition on Child Urine Cotinine||||0.007
72559654|NCT05740098|144649442|SUPERIORITY|||||||0.878|||||||Mixed Models Analysis|||Analysis tested for significant main effect of time on Child Urine Cotinine||||0.878
72559655|NCT05740098|144649443|SUPERIORITY||Chi-Square Test Statistic|6.909||||0.009|TWO_SIDED||||||Chi-squared|Degrees of freedom = 1||Analysis tested for significant main effect of treatment condition on continuous abstinence at 24 weeks following quit date||||0.009
72559656|NCT05740098|144649443|SUPERIORITY||Chi-Square Test Statistic|4.287||||0.038|TWO_SIDED||||||Chi-squared|Degrees of freedom = 1||Analysis tested for significant main effect of treatment condition on continuous abstinence at 24 weeks following quit date||||0.038
72559657|NCT05740098|144649443|SUPERIORITY||Chi-Square Test Statistic|0.392||||0.531|TWO_SIDED||||||Chi-squared|Degrees of freedom = 1||Analysis tested for significant main effect of treatment condition on continuous abstinence at 24 weeks following quit date||||0.531
72559658|NCT05740098|144649444|SUPERIORITY||Chi-Square Test Statistic|3.859||||0.145|TWO_SIDED||||||Chi-squared|Degrees of freedom = 2||Analysis tested for significant main effect of treatment condition on 7-day point prevalence abstinence at 48-week follow-up||||0.145
72559659|NCT05740098|144649445|SUPERIORITY||Wald Chi-Square Test Statistic|1.454||||0.228|TWO_SIDED||||||Regression, Logistic|||Analysis tested for significant main effect of baseline temporal discounting on point-prevalence abstinence at 6-weeks following quit date adjusting for treatment condition.||||0.228
72559660|NCT05740098|144649445|SUPERIORITY||Wald Chi-Square Test Statistic|2.7||||0.1|TWO_SIDED||||||Regression, Logistic|||Analysis tested for significant main effect of baseline temporal discounting on point-prevalence abstinence at 12-weeks following quit date adjusting for treatment condition.||||0.10
72559661|NCT05740098|144649445|SUPERIORITY||Wald Chi-Square Test Statistic|3.202||||0.074|TWO_SIDED||||||Regression, Logistic|||Analysis tested for significant main effect of baseline temporal discounting on point-prevalence abstinence at 24-weeks following quit date adjusting for treatment condition.||||0.074
72559662|NCT05740098|144649445|SUPERIORITY||Wald Chi-Square Test Statistic|0.491||||0.484|TWO_SIDED||||||Regression, Logistic|||Analysis tested for significant main effect of baseline temporal discounting on point-prevalence abstinence at 48-weeks following quit date adjusting for treatment condition.||||0.484
72559663|NCT05740098|144649446|SUPERIORITY||Wald Chi-Square Test Statistic|1.063||||0.302|TWO_SIDED||||||Regression, Logistic|||The analysis tested for significant association between baseline price sensitivity (latent factor Amplitude) and abstinence at 6-weeks following quit date||||0.302
72559664|NCT05740098|144649446|SUPERIORITY||Wald Chi-Square Test Statistic|0.788||||0.375|TWO_SIDED||||||Regression, Logistic|||The analysis tested for significant association between baseline price sensitivity (latent factor Amplitude) and abstinence at 12-weeks following quit date||||0.375
72559665|NCT05740098|144649446|SUPERIORITY||Wald Chi-Square Test Statistic|0.08||||0.777|TWO_SIDED||||||Regression, Logistic|||The analysis tested for significant association between baseline price sensitivity (latent factor Amplitude) and abstinence at 24-weeks following quit date||||0.777
72559666|NCT05740098|144649446|SUPERIORITY||Wald Chi-Square Test Statistic|0.006||||0.937|TWO_SIDED||||||Regression, Logistic|||The analysis tested for significant association between baseline price sensitivity (latent factor Amplitude) and abstinence at 48-weeks following quit date||||0.937
72559667|NCT05740098|144649446|SUPERIORITY||Wald Chi-Square Test Statistic|0.172||||0.678|TWO_SIDED||||||Regression, Logistic|||The analysis tested for significant association between baseline price sensitivity (latent factor Persistence) and abstinence at 6-weeks following quit date||||0.678
72559668|NCT05740098|144649446|SUPERIORITY||Wald Chi-Square Test Statistic|7.99||||0.018|TWO_SIDED||||||Regression, Logistic|||The analysis tested for significant interaction between baseline price sensitivity (latent factor Persistence) and treatment condition for 6-week abstinence outcome||||0.018
72559669|NCT05740098|144649446|SUPERIORITY||Wald Chi-Square Test Statistic|0.177||||0.674|TWO_SIDED||||||Regression, Logistic|||The analysis tested for significant association between baseline price sensitivity (latent factor Persistence) and abstinence at 12-weeks following quit date||||0.674
72559670|NCT05740098|144649446|SUPERIORITY||Wald Chi-Square Test Statistic|0.646||||0.422|TWO_SIDED||||||Regression, Logistic|||The analysis tested for significant association between baseline price sensitivity (latent factor Persistence) and abstinence at 24-weeks following quit date||||0.422
72559671|NCT05740098|144649446|SUPERIORITY||Wald Chi-Square Test Statistic|0.038||||0.846|TWO_SIDED||||||Regression, Logistic|||The analysis tested for significant association between baseline price sensitivity (latent factor Persistence) and abstinence at 48-weeks following quit date||||0.846
72496370|NCT00236080|144522573|NON_INFERIORITY_OR_EQUIVALENCE|Number of participants analyzed was determined by those participants who had at least 1 postbaseline efficacy assessment. Sample size requirements were not based on statistical considerations. There were 20 patients in each of the 5 treatment groups, for a total of 100 patients. It is expected that the sample size will provide sufficient information for describing the specified evaluations.||||||0.1236||||||The p-value of Overall Treatment to Placebo|ANCOVA|This analysis adjusted for the difference among the treatment groups at baseline.||Sample size requirements were not based on statistical considerations. The null hypothesis was Ho: μplacebo = μ150 = μ200 = μ250 = μprovigil versus Ha: at least 2 of the means are different, where μ represented the change from baseline to the endpoint.||||0.1236
72496371|NCT00236080|144522574|NON_INFERIORITY_OR_EQUIVALENCE|Using the adjusted p value from Tukey's least significant difference (LSD) test for armodafinil at 200 mg/day. Sample size requirements were not based on statistical considerations. There were 20 patients in each of the 5 treatment groups, for a total of 100 patients.||||||0.0945||||||The p-value of Overall Treatment to Placebo|ANCOVA|||Sample size requirements were not based on statistical considerations. The null hypothesis was Ho: μplacebo = μ150 = μ200 = μ250 = μprovigil versus Ha: at least 2 of the means are different, where μ represented the change from baseline to the endpoint .||||0.0945
72559672|NCT02452463|144649451|SUPERIORITY|||||||0.107|||||||Cochran-Mantel-Haenszel|||||||0.107
72496372|NCT03213366|144522618|SUPERIORITY||Slope|-0.0095||||0.5783|TWO_SIDED|95.0|-0.04676|0.02776|||Mixed Models Analysis|||At 6 weeks.||0.02776|-0.04676|0.5783
72496373|NCT03213366|144522618|SUPERIORITY||Slope|-0.01692||||0.3185|TWO_SIDED|95.0|-0.05318|0.01933|||Mixed Models Analysis|||At 12 weeks.||0.01933|-0.05318|0.3185
72496374|NCT03213366|144522619|SUPERIORITY||Slope|0.03674||||0.07863|TWO_SIDED|95.0|-0.00516|0.07863|||Mixed Models Analysis|||At 6 weeks.||0.07863|-0.00516|0.07863
72496375|NCT03213366|144522619|SUPERIORITY||Slope|0.02594||||0.1999|TWO_SIDED|95.0|-0.01648|0.06836|||Mixed Models Analysis|||At 12 weeks.||0.06836|-0.01648|0.1999
72559673|NCT02452463|144649453|SUPERIORITY|||||||0.75|||||||Log Rank|||Null Hypotheses: OS distributions are equal||||0.75
72559674|NCT02452463|144649454|SUPERIORITY|||||||0.25|||||||Log Rank|||Null Hypotheses: PFS distributions are equal||||0.25
72559675|NCT02452463|144649455|SUPERIORITY|||||||0.131|||||||t-test, 2 sided|||||||0.131
72559676|NCT02452463|144649456|SUPERIORITY|||||||0.073|||||||t-test, 2 sided|||||||0.073
72388238|NCT01786668|144284408|SUPERIORITY_OR_OTHER||Risk Difference (RD)|5.73|STANDARD_ERROR_OF_MEAN|4.17||0.17|TWO_SIDED|95.0|-2.45|13.91|||Normal approximation for two proportions|||Week 2||13.91|-2.45|0.170
72388239|NCT01786668|144284408|SUPERIORITY_OR_OTHER||Risk Difference (RD)|5.66|STANDARD_ERROR_OF_MEAN|5.52||0.306|TWO_SIDED|95.0|-5.17|16.48|||Normal approximation for two proportions|||Week 4||16.48|-5.17|0.306
72388240|NCT01786668|144284408|SUPERIORITY_OR_OTHER||Risk Difference (RD)|5.66|STANDARD_ERROR_OF_MEAN|5.52||0.306|TWO_SIDED|95.0|-5.17|16.48|||Normal approximation for two proportions|||Week 4||16.48|-5.17|0.306
72388241|NCT01786668|144284408|SUPERIORITY_OR_OTHER||Risk Difference (RD)|9.5|STANDARD_ERROR_OF_MEAN|5.99||0.113|TWO_SIDED|95.0|-2.24|21.24|||Normal approximation for two proportions|||Week 4||21.24|-2.24|0.113
72388242|NCT01786668|144284408|SUPERIORITY_OR_OTHER||Risk Difference (RD)|1.73|STANDARD_ERROR_OF_MEAN|6.08||0.775|TWO_SIDED|95.0|-10.18|13.65|||Normal approximation for two proportions|||Week 8||13.65|-10.18|0.775
72388243|NCT01786668|144284408|SUPERIORITY_OR_OTHER||Risk Difference (RD)|17.12|STANDARD_ERROR_OF_MEAN|7.43||0.021|TWO_SIDED|95.0|2.56|31.68|||Normal approximation for two proportions|||Week 8||31.68|2.56|0.021
72388244|NCT01786668|144284408|SUPERIORITY_OR_OTHER||Risk Difference (RD)|13.27|STANDARD_ERROR_OF_MEAN|7.17||0.064|TWO_SIDED|95.0|-0.79|27.34|||Normal approximation for two proportions|||Week 8||27.34|-0.79|0.064
72388245|NCT01786668|144284408|SUPERIORITY_OR_OTHER||Risk Difference (RD)|7.47|STANDARD_ERROR_OF_MEAN|7.09||0.292|TWO_SIDED|95.0|-6.42|21.36|||Normal approximation for two proportions|||Week 12||21.36|-6.42|0.292
72388246|NCT01786668|144284408|SUPERIORITY_OR_OTHER||Risk Difference (RD)|11.31|STANDARD_ERROR_OF_MEAN|7.38||0.125|TWO_SIDED|95.0|-3.16|25.78|||Normal approximation for two proportions|||Week 12||25.78|-3.16|0.125
72388247|NCT01786668|144284408|SUPERIORITY_OR_OTHER||Risk Difference (RD)|13.24|STANDARD_ERROR_OF_MEAN|7.51||0.078|TWO_SIDED|95.0|-1.49|27.96|||Normal approximation for two proportions|||Week 12||27.96|-1.49|0.078
72388248|NCT01786668|144284409|SUPERIORITY_OR_OTHER||Risk Difference (RD)|1.92|STANDARD_ERROR_OF_MEAN|1.9||0.313|TWO_SIDED|95.0|-1.81|5.66|||Normal approximation for two proportions|||Week 2||5.66|-1.81|0.313
72388249|NCT01786668|144284409|SUPERIORITY_OR_OTHER||Risk Difference (RD)|1.92|STANDARD_ERROR_OF_MEAN|1.9||0.313|TWO_SIDED|95.0|-1.81|5.66|||Normal approximation for two proportions|||Week 2||5.66|-1.81|0.313
72496376|NCT03213366|144522620|SUPERIORITY||Slope|0.000443||||0.8963|TWO_SIDED||||||Mixed Models Analysis|||At 6 weeks.||||0.8963
72496377|NCT03213366|144522620|SUPERIORITY||Slope|0.004308||||0.3229|TWO_SIDED||||||Mixed Models Analysis|||At 12 weeks||||0.3229
72496378|NCT03213366|144522621|SUPERIORITY||Slope|0.008705||||0.2433|TWO_SIDED|||||This t-test was for the random effects model not for comparing the difference between the arms.|Mixed Models Analysis|||||||0.2433
72559677|NCT02452463|144649457|SUPERIORITY|||||||0.616|||||||t-test, 2 sided|||||||0.616
72559678|NCT02452463|144649457|SUPERIORITY|||||||0.183|||||||Paired T-test|||Comparing change relative to baseline.||||0.183
72559679|NCT02452463|144649457|SUPERIORITY|||||||0.203|||||||paired T-test|||Evaluating change relative to baseline.||||0.203
72559680|NCT02452463|144649458|SUPERIORITY|||||||1|||||||Cochran-Mantel-Haenszel|||||||1.00
72559681|NCT01894230|144649472|EQUIVALENCE|Month 3|Slope|-0.0189|STANDARD_ERROR_OF_MEAN|0.3986||0.96|TWO_SIDED||||||Regression, Linear|||||||0.96
72559682|NCT01894230|144649472|EQUIVALENCE|Month 8|Slope|-0.2468|STANDARD_ERROR_OF_MEAN|0.4315||0.57|TWO_SIDED||||||Regression, Linear|||||||0.57
72559683|NCT01894230|144649473|EQUIVALENCE|Month 3|Slope|-11.32|STANDARD_ERROR_OF_MEAN|5.68||0.0482|TWO_SIDED||||||Regression, Linear|||||||0.0482
72559684|NCT01894230|144649473|EQUIVALENCE|Month 8|Slope|-9.9|STANDARD_ERROR_OF_MEAN|6.333||0.12|TWO_SIDED||||||Regression, Linear|||||||0.12
72559685|NCT01894230|144649474|EQUIVALENCE|MPR calculated from baseline to last patient follow-up (3 months or 8 months)|Slope|-0.053|STANDARD_ERROR_OF_MEAN|0.091||0.6692|TWO_SIDED||||||Regression, Linear|||||||0.6692
72559686|NCT01894230|144649475|EQUIVALENCE|Baseline to Month 3|Odds Ratio (OR)|2.025||||0.0371|TWO_SIDED|95.0|1.043|3.929|||Regression, Logistic|||||3.929|1.043|0.0371
72496379|NCT03213366|144522621|SUPERIORITY||Slope|0.01358||||0.0839|TWO_SIDED||||||Mixed Models Analysis|||At 12 weeks.||||0.0839
72442287|NCT04714320|144397610|SUPERIORITY||||||<|0.001||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]) and treatment received were included in the Van Elteren model as independent variables.|Van Elteren|||Change from Baseline at Day 106||||<0.001
72442288|NCT04714320|144397610|SUPERIORITY||||||<|0.001||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables|ANCOVA|||Change from Baseline at Day 120||||<0.001
72442289|NCT04714320|144397610|SUPERIORITY||||||<|0.001||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables|ANCOVA|||Change from Baseline at Day 120||||<0.001
72442290|NCT04714320|144397610|SUPERIORITY||||||<|0.001||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]) and treatment received were included in the Van Elteren model as independent variables.|Van Elteren|||Change from Baseline at Day 148||||<0.001
72442291|NCT04714320|144397610|SUPERIORITY||||||=|0.002||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]) and treatment received were included in the Van Elteren model as independent variables.|Van Elteren|||Change from Baseline at Day 148||||=0.002
72442292|NCT04714320|144397610|SUPERIORITY||||||<|0.001||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]) and treatment received were included in the Van Elteren model as independent variables.|Van Elteren|||Change from Baseline at Day 169||||<0.001
72442293|NCT04714320|144397610|SUPERIORITY||||||=|0.002||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]) and treatment received were included in the Van Elteren model as independent variables.|Van Elteren|||Change from Baseline at Day 169||||=0.002
72442294|NCT04714320|144397611|SUPERIORITY||||||<|0.001||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Percent Change from Baseline at Day 15||||<0.001
72559687|NCT01894230|144649475|EQUIVALENCE|Month 3 to Month 8|Odds Ratio (OR)|1.115||||0.8815|TWO_SIDED|95.0|0.265|4.687|||Regression, Logistic|||||4.687|0.265|0.8815
72559688|NCT01894230|144649476|EQUIVALENCE|Month 3|Slope|0.143|STANDARD_ERROR_OF_MEAN|0.27||0.5965|TWO_SIDED||||||Regression, Linear|||||||0.5965
72619055|NCT01755156|144768803|SUPERIORITY_OR_OTHER||Between-group rate difference (%)|19.2|||<|0.001|TWO_SIDED|95.0|10.1|28.0|||Miettinen & Nurminen method|||||28.0|10.1|<0.001
72442295|NCT04714320|144397611|SUPERIORITY||||||<|0.001||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Percent Change from Baseline at Day 15||||<0.001
72442296|NCT04714320|144397611|SUPERIORITY||||||<|0.001||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Percent Change from Baseline at Day at 29||||<0.001
72442297|NCT04714320|144397611|SUPERIORITY||||||<|0.001||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Percent Change from Baseline at Day at 29||||<0.001
72442298|NCT04714320|144397611|SUPERIORITY||||||<|0.001||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]) and treatment received were included in the Van Elteren model as independent variables.|Van Elteren|||Percent Change from Baseline at Day 43||||<0.001
72442299|NCT04714320|144397611|SUPERIORITY||||||<|0.001||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]) and treatment received were included in the Van Elteren model as independent variables.|Van Elteren|||Percent Change from Baseline at Day 43||||<0.001
72442300|NCT04714320|144397611|SUPERIORITY||||||<|0.001||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Percent Change from Baseline at Day 57||||<0.001
72442301|NCT04714320|144397611|SUPERIORITY||||||<|0.001||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Percent Change from Baseline at Day 57||||<0.001
72442302|NCT04714320|144397611|SUPERIORITY||||||<|0.001||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]) and treatment received were included in the Van Elteren model as independent variables.|Van Elteren|||Percent Change from Baseline at Day 71||||<0.001
72442303|NCT04714320|144397611|SUPERIORITY||||||<|0.001||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]) and treatment received were included in the Van Elteren model as independent variables.|Van Elteren|||Percent Change from Baseline at Day 71||||<0.001
72442304|NCT04714320|144397611|SUPERIORITY||||||<|0.001||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]) and treatment received were included in the Van Elteren model as independent variables.|Van Elteren|||Percent Change from Baseline at Day 85||||<0.001
72442305|NCT04714320|144397611|SUPERIORITY||||||<|0.001||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]) and treatment received were included in the Van Elteren model as independent variables.|Van Elteren|||Percent Change from Baseline at Day 85||||<0.001
72442306|NCT04714320|144397611|SUPERIORITY||||||<|0.001||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]) and treatment received were included in the Van Elteren model as independent variables.|Van Elteren|||Percent Change from Baseline at Day 92||||<0.001
72496380|NCT03213366|144522622|SUPERIORITY||Slope|-0.302||||0.2114|TWO_SIDED||||||Mixed Models Analysis|||At 6 weeks.||||0.2114
72496381|NCT03213366|144522622|SUPERIORITY||Slope|-0.03149||||0.2141|TWO_SIDED||||||Mixed Models Analysis|||At 12 weeks.||||0.2141
72559689|NCT01894230|144649476|EQUIVALENCE|Month 8|Slope|0.258|STANDARD_ERROR_OF_MEAN|0.346||0.4579|TWO_SIDED||||||Regression, Linear|||||||0.4579
72559690|NCT01894230|144649477|EQUIVALENCE|Month 3|Slope|0.098|STANDARD_ERROR_OF_MEAN|0.163||0.5477|TWO_SIDED||||||Regression, Linear|||||||0.5477
72559691|NCT01894230|144649477|EQUIVALENCE|Month 8|Slope|0.298|STANDARD_ERROR_OF_MEAN|0.145||0.0429|TWO_SIDED||||||Regression, Linear|||||||0.0429
72559692|NCT01894230|144649478|EQUIVALENCE|Month 3|Slope|-0.211|STANDARD_ERROR_OF_MEAN|0.881||0.8106|TWO_SIDED||||||Regression, Linear|||||||0.8106
72388250|NCT01786668|144284409|SUPERIORITY_OR_OTHER||Risk Difference (RD)|1.92|STANDARD_ERROR_OF_MEAN|1.9||0.313|TWO_SIDED|95.0|-1.81|5.66|||Normal approximation for two proportions|||Week 2||5.66|-1.81|0.313
72388251|NCT01786668|144284409|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.04|STANDARD_ERROR_OF_MEAN|2.72||0.989|TWO_SIDED|95.0|-5.37|5.29|||Normal approximation for two proportions|||Week 4||5.29|-5.37|0.989
72388252|NCT01786668|144284409|SUPERIORITY_OR_OTHER||Risk Difference (RD)|3.81|STANDARD_ERROR_OF_MEAN|3.77||0.313|TWO_SIDED|95.0|-3.58|11.2|||Normal approximation for two proportions|||Week 4||11.20|-3.58|0.313
72388253|NCT01786668|144284409|SUPERIORITY_OR_OTHER||Risk Difference (RD)|5.73|STANDARD_ERROR_OF_MEAN|4.17||0.17|TWO_SIDED|95.0|-2.45|13.91|||Normal approximation for two proportions|||Week 4||13.91|-2.45|0.170
72388254|NCT01786668|144284409|SUPERIORITY_OR_OTHER||Risk Difference (RD)|3.81|STANDARD_ERROR_OF_MEAN|3.77||0.313|TWO_SIDED|95.0|-3.58|11.2|||Normal approximation for two proportions|||Week 8||11.20|-3.58|0.313
72388255|NCT01786668|144284409|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.04|STANDARD_ERROR_OF_MEAN|2.72||0.989|TWO_SIDED|95.0|-5.37|5.29|||Normal approximation for two proportions|||Week 8||5.29|-5.37|0.989
72388256|NCT01786668|144284409|SUPERIORITY_OR_OTHER||Risk Difference (RD)|7.65|STANDARD_ERROR_OF_MEAN|4.53||0.091|TWO_SIDED|95.0|-1.22|16.52|||Normal approximation for two proportions|||Week 8||16.52|-1.22|0.091
72388257|NCT01786668|144284409|SUPERIORITY_OR_OTHER||Risk Difference (RD)|5.62|STANDARD_ERROR_OF_MEAN|6.05||0.353|TWO_SIDED|95.0|-6.23|17.47|||Normal approximation for two proportions|||Week 12||17.47|-6.23|0.353
72388258|NCT01786668|144284409|SUPERIORITY_OR_OTHER||Risk Difference (RD)|5.62|STANDARD_ERROR_OF_MEAN|6.05||0.353|TWO_SIDED|95.0|-6.23|17.47|||Normal approximation for two proportions|||Week 12||17.47|-6.23|0.353
72388259|NCT01786668|144284409|SUPERIORITY_OR_OTHER||Risk Difference (RD)|7.54|STANDARD_ERROR_OF_MEAN|6.26||0.228|TWO_SIDED|95.0|-4.73|19.81|||Normal approximation for two proportions|||Week 12||19.81|-4.73|0.228
72388260|NCT01786668|144284410|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.03|STANDARD_ERROR_OF_MEAN|0.31||0.926|TWO_SIDED|95.0|-0.64|0.58|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 2||0.58|-0.64|0.926
72388261|NCT01786668|144284410|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.11|STANDARD_ERROR_OF_MEAN|0.308||0.718|TWO_SIDED|95.0|-0.72|0.5|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 2||0.50|-0.72|0.718
72388262|NCT01786668|144284410|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.18|STANDARD_ERROR_OF_MEAN|0.31||0.57|TWO_SIDED|95.0|-0.43|0.79|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 2||0.79|-0.43|0.570
72388263|NCT01786668|144284410|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.343||0.384|TWO_SIDED|95.0|-0.97|0.38|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 4||0.38|-0.97|0.384
72388264|NCT01786668|144284410|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.33|STANDARD_ERROR_OF_MEAN|0.341||0.334|TWO_SIDED|95.0|-1.0|0.34|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 4||0.34|-1.00|0.334
72388265|NCT01786668|144284410|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.25|STANDARD_ERROR_OF_MEAN|0.343||0.474|TWO_SIDED|95.0|-0.92|0.43|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 4||0.43|-0.92|0.474
72388266|NCT01786668|144284410|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.29|STANDARD_ERROR_OF_MEAN|0.381||0.445|TWO_SIDED|95.0|-1.04|0.46|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 8||0.46|-1.04|0.445
72388267|NCT01786668|144284410|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.52|STANDARD_ERROR_OF_MEAN|0.38||0.174|TWO_SIDED|95.0|-1.27|0.23|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 8||0.23|-1.27|0.174
72388268|NCT01786668|144284410|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.47|STANDARD_ERROR_OF_MEAN|0.383||0.217|TWO_SIDED|95.0|-1.23|0.28|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 8||0.28|-1.23|0.217
72388269|NCT01786668|144284410|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9|STANDARD_ERROR_OF_MEAN|0.396||0.024|TWO_SIDED|95.0|-1.69|-0.12|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 12||-0.12|-1.69|0.024
72388270|NCT01786668|144284410|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.03|STANDARD_ERROR_OF_MEAN|0.396||0.01|TWO_SIDED|95.0|-1.81|-0.24|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 12||-0.24|-1.81|0.010
72388271|NCT01786668|144284410|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.83|STANDARD_ERROR_OF_MEAN|0.399||0.038|TWO_SIDED|95.0|-1.62|-0.04|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 12||-0.04|-1.62|0.038
72388272|NCT01786668|144284411|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-4.15|STANDARD_ERROR_OF_MEAN|6.75||0.539|TWO_SIDED|95.0|-17.38|9.08|||Normal approximation for two proportions|||Week 2||9.08|-17.38|0.539
72559693|NCT01894230|144649478|EQUIVALENCE|Month 8|Slope|0.646|STANDARD_ERROR_OF_MEAN|1.009||0.5233|TWO_SIDED||||||Regression, Linear|||||||0.5233
72559694|NCT01894230|144649479|EQUIVALENCE|Month 3|Slope|-0.6001|STANDARD_ERROR_OF_MEAN|1.472||0.6841|TWO_SIDED||||||Regression, Linear|||||||0.6841
72559695|NCT01894230|144649479|EQUIVALENCE|Month 8|Slope|-0.771|STANDARD_ERROR_OF_MEAN|1.781||0.6658|TWO_SIDED||||||Regression, Linear|||||||0.6658
72496382|NCT03213366|144522623|SUPERIORITY||Slope|0.0278||||0.0124|TWO_SIDED||||||Mixed Models Analysis|||At 6 weeks.||||0.0124
72496383|NCT03213366|144522623|SUPERIORITY||Slope|0.03052||||0.0022|TWO_SIDED||||||Mixed Models Analysis|||At 12 weeks.||||0.0022
72496384|NCT03213366|144522624|SUPERIORITY||Slope|-0.05747||||0.1021|TWO_SIDED||||||Mixed Models Analysis|||At 6 weeks.||||0.1021
72496385|NCT03213366|144522624|SUPERIORITY||Slope|-0.05101||||0.133|TWO_SIDED||||||Mixed Models Analysis|||At 12 weeks.||||0.133
72496386|NCT03213366|144522625|SUPERIORITY||Slope|-0.0209||||0.0818|TWO_SIDED||||||Mixed Models Analysis|||At 6 weeks.||||0.0818
72496387|NCT03213366|144522625|SUPERIORITY||Slope|0.03103||||0.0334|TWO_SIDED||||||Mixed Models Analysis|||At 12 weeks.||||0.0334
72442307|NCT04714320|144397611|SUPERIORITY||||||<|0.001||||||The stratification factor (screening eGFR status (\<60 vs ≥60 mL/min/1.73 m2)) and treatment received were included in the Van Elteren model as independent variables|Van Elteren|||Percent Change from Baseline at Day 92||||<0.001
72496388|NCT02532855|144522629|NON_INFERIORITY|For the primary hypothesis, sitagliptin will be considered non-inferior to dapagliflozin if the upper bound of the two-sided 95% confidence interval (CI) of the between-group difference in least squares mean change from baseline in A1C (sitagliptin minus dapagliflozin) is less than 0.3% (the non-inferiority margin). Longitudinal data analysis (LDA), Antihyperglycemic agent (AHA), Least squares means (LSM)|Difference in LSM (Sit. - Dap.)|-0.15|||||TWO_SIDED|95.0|-0.26|-0.04||||LDA model including terms for treatment, time, background AHA, the interaction of time and background AHA, and the interaction of time by treatment.||||-0.04|-0.26|
72496389|NCT02532855|144522629|SUPERIORITY||Difference in LSM (Sit. - Dap.)|-0.15||||0.006|TWO_SIDED|95.0|-0.26|-0.04|||Longitudinal data analysis|LDA model including terms for treatment, time, background AHA, the interaction of time and background AHA, and the interaction of time by treatment.||||-0.04|-0.26|0.006
72496390|NCT02532855|144522630|OTHER||Difference in % (Sit. - Dap.)|-2.8|||||TWO_SIDED|95.0|-10.7|5.1||||Miettinen \& Nurminen method||||5.1|-10.7|
72496391|NCT02532855|144522631|OTHER||Difference in % (Sit. - Dap.)|0.0|||||TWO_SIDED|95.0|-3.0|3.0||||Miettinen \& Nurminen method||||3.0|-3.0|
72496392|NCT02532855|144522632|SUPERIORITY||Difference in LSM (Sit. - Dap.)|-5.7||||0.138|TWO_SIDED|95.0|-13.3|1.8|||LDA|LDA model including terms for treatment, time, background AHA, the interaction of time and background AHA, and the interaction of time by treatment.||||1.8|-13.3|0.138
72496393|NCT02532855|144522633|SUPERIORITY||Difference in the LSM (Sit. - Dap.)|-3.4|||||TWO_SIDED|95.0|-12.1|5.3||||The ANCOVA model included terms for treatment, background AHA, and the baseline 2-hour PPG value as a covariate.||||5.3|-12.1|
72442308|NCT04714320|144397611|SUPERIORITY||||||<|0.001||||||The stratification factor (screening eGFR status (\<60 vs ≥60 mL/min/1.73 m2)) and treatment received were included in the Van Elteren model as independent variables.|Van Elteren|||Percent Change from Baseline at Day 106||||<0.001
72496394|NCT02532855|144522634|SUPERIORITY||Difference in the LSM (Sit. - Dap.)|-4.4|||||TWO_SIDED|95.0|-10.1|1.4||||The ANCOVA model included terms for treatment, background AHA, and the baseline glucagon AUC value as a covariate.||||1.4|-10.1|
72496395|NCT02532855|144522635|SUPERIORITY||Difference in the LSM (Sit. - Dap.)|4.9|||||TWO_SIDED|95.0|-12.2|22.0||||The ANCOVA model included terms for treatment, background AHA, and the baseline insulin AUC value as a covariate.||||22.0|-12.2|
72496396|NCT02532855|144522636|SUPERIORITY||Difference in the LSM (Sit. - Dap.)|0.6|||||TWO_SIDED|95.0|-0.1|1.3||||The ANCOVA model included terms for treatment, background AHA, and the baseline insulin AUC to glucagon AUC ratio value as a covariate.||||1.3|-0.1|
72496397|NCT02532855|144522637|OTHER|The percentage of participants was estimated using standard multiple imputation techniques from LDA model including terms for treatment, time, background AHA, the interaction of time and background AHA, and the interaction of time by treatment.|Difference in % (Sit. - Dap.)|15.5|||||TWO_SIDED|95.0|7.7|23.2||||Miettinen and Nurminen (M\&N) method with multiple imputation from a LDA Model.||||23.2|7.7|
72496398|NCT02532855|144522638|SUPERIORITY||Difference in the LSM (Sit. - Dap.)|3.5|||||TWO_SIDED|95.0|-1.2|8.3||||LDA model including terms for treatment, time, background AHA, the interaction of time and background AHA, and the interaction of time by treatment.||||8.3|-1.2|
72496399|NCT01727258|144522639|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.85|STANDARD_ERROR_OF_MEAN|1.72|<|0.001|TWO_SIDED|95.0|7.45|14.25||If Potassium Oxalate Mouthrinse is better than Colgate Regular (p\<0.05), testing would proceed to comparison of Wk 2 Mean Tactile Sensitivity Scores between Potassium Oxalate Mouthrinse and Colgate Regular. Family-wise error was controlled at 0.05.|ANCOVA|Terms included treatment and baseline mean tactile sensitivity (Yeaple probe) score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||14.25|7.45|<0.001
72504760|NCT03114969|144540504|SUPERIORITY||Odds Ratio (OR)|1.747||||0.179|TWO_SIDED|95.0|0.775|3.937||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Incruse/Anoro Ellipta as comparator.|||3.937|0.775|0.179
72504761|NCT03114969|144540504|SUPERIORITY||Odds Ratio (OR)|1.189||||0.69|TWO_SIDED|95.0|0.509|2.775||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator.|||2.775|0.509|0.690
72504762|NCT03114969|144540504|SUPERIORITY||Odds Ratio (OR)|3.363||||0.004|TWO_SIDED|95.0|1.48|7.639||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator.|||7.639|1.480|0.004
72504763|NCT03114969|144540504|SUPERIORITY||Odds Ratio (OR)|2.848||||0.012|TWO_SIDED|95.0|1.264|6.42||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator.|||6.420|1.264|0.012
72504764|NCT03114969|144540504|SUPERIORITY||Odds Ratio (OR)|4.63|||<|0.001|TWO_SIDED|95.0|1.986|10.791||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Incruse/Anoro Ellipta as comparator.|||10.791|1.986|<0.001
72559696|NCT01894230|144649480|EQUIVALENCE|Month 8|Odds Ratio (OR)|1.085||||0.8384|TWO_SIDED|95.0|0.495|2.38|||Regression, Logistic|Ordinal Logistic||||2.380|0.495|0.8384
72442309|NCT04714320|144397611|SUPERIORITY||||||<|0.001||||||The stratification factor (screening eGFR status (\<60 vs ≥60 mL/min/1.73 m2)) and treatment received were included in the Van Elteren model as independent variables.|Van Elteren|||Percent Change from Baseline at Day 106||||<0.001
72442310|NCT04714320|144397611|SUPERIORITY||||||<|0.001||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Percent Change from Baseline at Day 120||||<0.001
72442311|NCT04714320|144397611|SUPERIORITY||||||<|0.001||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Percent Change from Baseline at Day 120||||<0.001
72442312|NCT04714320|144397611|SUPERIORITY||||||<|0.001||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Percent Change from Baseline at Day 148||||<0.001
72442313|NCT04714320|144397611|SUPERIORITY||||||=|0.005||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Percent Change from Baseline at Day 148||||=0.005
72442314|NCT04714320|144397611|SUPERIORITY||||||<|0.001||||||The stratification factor (screening eGFR status (\<60 vs ≥60 mL/min/1.73 m2)) and treatment received were included in the Van Elteren model as independent variables.|Van Elteren|||Percent Change from Baseline at Day 169||||<0.001
72442315|NCT04714320|144397611|SUPERIORITY||||||=|0.002||||||The stratification factor (screening eGFR status (\<60 vs ≥60 mL/min/1.73 m2)) and treatment received were included in the Van Elteren model as independent variables.|Van Elteren|||Percent Change from Baseline at Day 169||||=0.002
72496400|NCT01727258|144522639|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.74|STANDARD_ERROR_OF_MEAN|1.729||0.314|TWO_SIDED|95.0|-5.16|1.67||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline mean tactile sensitivity (Yeaple probe) score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||1.67|-5.16|0.314
72496401|NCT01727258|144522639|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.6|STANDARD_ERROR_OF_MEAN|1.735|<|0.001|TWO_SIDED|95.0|9.17|16.03||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline mean tactile sensitivity (Yeaple probe) score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||16.03|9.17|<0.001
72504662|NCT02495077|144540088|SUPERIORITY||Mean Difference (Final Values)|-1.64||||0.519|TWO_SIDED|95.0|-6.66|3.37|||Mixed Models Analysis|||Day 90. Mean eGFR of the two treatment groups was compared. The p-value, estimated day 90 eGFR within each treatment group, estimate of the treatment group difference, and estimated 95% confidence interval result from a repeated measures mixed model using available eGFR data from months 1, 3, 6, 12, 18, and 24 to compare the experimental group to the control group at day 90. Random effects for the intercept and eGFR collection day were utilized in the model.||3.37|-6.66|0.519
72559697|NCT01894230|144649481|EQUIVALENCE|Month 3 BMQ Necessity|Slope|1.163|STANDARD_ERROR_OF_MEAN|0.584||0.0486|TWO_SIDED||||||Regression, Linear|||||||0.0486
72442316|NCT04714320|144397612|SUPERIORITY||||||=|0.094||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline in 24-hour Mean SBP at Day 85||||=0.094
72442317|NCT04714320|144397612|SUPERIORITY||||||=|0.842||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline in 24-hour Mean SBP at Day 85||||=0.842
72442318|NCT04714320|144397612|SUPERIORITY||||||=|0.066||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change From Baseline in 24-hour Mean DBP at Day 85||||=0.066
72442319|NCT04714320|144397612|SUPERIORITY||||||=|0.442||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change From Baseline in 24-hour Mean DBP at Day 85||||=0.442
72442320|NCT04714320|144397613|SUPERIORITY||||||=|0.834||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in the Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg at Day 8||||=0.834
72442321|NCT04714320|144397613|SUPERIORITY||||||=|0.945||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in the Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg at Day 8||||=0.945
72442322|NCT04714320|144397613|SUPERIORITY||||||=|0.208||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in the Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg at Day 15||||=0.208
72442323|NCT04714320|144397613|SUPERIORITY||||||=|0.74||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in the Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg at Day 15||||=0.740
72442324|NCT04714320|144397613|SUPERIORITY||||||=|0.019||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in the Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg at Day 22||||=0.019
72559698|NCT01894230|144649481|EQUIVALENCE|Month 8, BMQ Necessity|Slope|0.248|STANDARD_ERROR_OF_MEAN|0.67||0.7235|TWO_SIDED||||||Regression, Linear|||||||0.7235
72442325|NCT04714320|144397613|SUPERIORITY||||||=|0.56||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in the Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg at Day 22||||=0.560
72496402|NCT01727258|144522640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.08|STANDARD_ERROR_OF_MEAN|1.177|<|0.001|TWO_SIDED|95.0|3.76|8.41||If Potassium Oxalate Mouthrinse is better than Colgate Regular (p\<0.05), testing would proceed to comparison of Wk 2 Mean Tactile Sensitivity Scores between Potassium Oxalate Mouthrinse and Sensodyne. Family-wise error was controlled at 0.05.|ANCOVA|Terms included treatment and baseline mean tactile sensitivity (Yeaple probe) score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||8.41|3.76|<0.001
72559699|NCT01894230|144649481|EQUIVALENCE|Month 3, BMQ Concerns|Slope|-0.862|STANDARD_ERROR_OF_MEAN|0.686||0.2113|TWO_SIDED||||||Regression, Linear|||||||0.2113
72388273|NCT01786668|144284411|SUPERIORITY_OR_OTHER||Risk Difference (RD)|5.47|STANDARD_ERROR_OF_MEAN|7.62||0.473|TWO_SIDED|95.0|-9.46|20.4|||Normal approximation for two proportions|||Week 2||20.40|-9.46|0.473
72388274|NCT01786668|144284411|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-2.22|STANDARD_ERROR_OF_MEAN|6.95||0.749|TWO_SIDED|95.0|-15.85|11.4|||Normal approximation for two proportions|||Week 2||11.40|-15.85|0.749
72388275|NCT01786668|144284411|SUPERIORITY_OR_OTHER||Risk Difference (RD)|7.28|STANDARD_ERROR_OF_MEAN|8.52||0.393|TWO_SIDED|95.0|-9.43|23.98|||Normal approximation for two proportions|||Week 4||23.98|-9.43|0.393
72388276|NCT01786668|144284411|SUPERIORITY_OR_OTHER||Risk Difference (RD)|1.51|STANDARD_ERROR_OF_MEAN|8.2||0.854|TWO_SIDED|95.0|-14.57|17.59|||Normal approximation for two proportions|||Week 4||17.59|-14.57|0.854
72388277|NCT01786668|144284411|SUPERIORITY_OR_OTHER||Risk Difference (RD)|7.28|STANDARD_ERROR_OF_MEAN|8.52||0.393|TWO_SIDED|95.0|-9.43|23.98|||Normal approximation for two proportions|||Week 4||23.98|-9.43|0.393
72388278|NCT01786668|144284411|SUPERIORITY_OR_OTHER||Risk Difference (RD)|7.16|STANDARD_ERROR_OF_MEAN|9.09||0.43|TWO_SIDED|95.0|-10.65|24.97|||Normal approximation for two proportions|||Week 8||24.97|-10.65|0.430
72388279|NCT01786668|144284411|SUPERIORITY_OR_OTHER||Risk Difference (RD)|5.24|STANDARD_ERROR_OF_MEAN|9.02||0.561|TWO_SIDED|95.0|-12.44|22.92|||Normal approximation for two proportions|||Week 8||22.92|-12.44|0.561
72388280|NCT01786668|144284411|SUPERIORITY_OR_OTHER||Risk Difference (RD)|12.93|STANDARD_ERROR_OF_MEAN|9.24||0.162|TWO_SIDED|95.0|-5.17|31.04|||Normal approximation for two proportions|||Week 8||31.04|-5.17|0.162
72388281|NCT01786668|144284411|SUPERIORITY_OR_OTHER||Risk Difference (RD)|22.62|STANDARD_ERROR_OF_MEAN|9.11||0.013|TWO_SIDED|95.0|4.76|40.49|||Normal approximation for two proportions|||Week 12||40.49|4.76|0.013
72388282|NCT01786668|144284411|SUPERIORITY_OR_OTHER||Risk Difference (RD)|18.78|STANDARD_ERROR_OF_MEAN|9.07||0.038|TWO_SIDED|95.0|1.01|36.55|||Normal approximation for two proportions|||Week 12||36.55|1.01|0.038
72388283|NCT01786668|144284411|SUPERIORITY_OR_OTHER||Risk Difference (RD)|18.78|STANDARD_ERROR_OF_MEAN|9.07||0.038|TWO_SIDED|95.0|1.01|36.55|||Normal approximation for two proportions|||Week 12||36.55|1.01|0.038
72388284|NCT01786668|144284412|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.38|STANDARD_ERROR_OF_MEAN|0.272||0.164|TWO_SIDED|95.0|-0.92|0.16|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 2||0.16|-0.92|0.164
72388285|NCT01786668|144284412|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.41|STANDARD_ERROR_OF_MEAN|0.271||0.129|TWO_SIDED|95.0|-0.95|0.12|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 2||0.12|-0.95|0.129
72388286|NCT01786668|144284412|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.12|STANDARD_ERROR_OF_MEAN|0.272||0.66|TWO_SIDED|95.0|-0.66|0.42|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 2||0.42|-0.66|0.660
72388287|NCT01786668|144284412|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.34|STANDARD_ERROR_OF_MEAN|0.297||0.256|TWO_SIDED|95.0|-0.92|0.25|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 4||0.25|-0.92|0.256
72388288|NCT01786668|144284412|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.59|STANDARD_ERROR_OF_MEAN|0.296||0.048|TWO_SIDED|95.0|-1.17|0.0|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 4||-0.00|-1.17|0.048
72388289|NCT01786668|144284412|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.297||0.318|TWO_SIDED|95.0|-0.88|0.29|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 4||0.29|-0.88|0.318
72388290|NCT01786668|144284412|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.22|STANDARD_ERROR_OF_MEAN|0.35||0.522|TWO_SIDED|95.0|-0.92|0.47|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 8||0.47|-0.92|0.522
72388291|NCT01786668|144284412|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.69|STANDARD_ERROR_OF_MEAN|0.35||0.05|TWO_SIDED|95.0|-1.38|0.0|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 8||0.00|-1.38|0.050
72388292|NCT01786668|144284412|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.34|STANDARD_ERROR_OF_MEAN|0.352||0.337|TWO_SIDED|95.0|-1.03|0.36|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 8||0.36|-1.03|0.337
72442326|NCT04714320|144397613|SUPERIORITY||||||=|0.903||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure are included in Logistic Regression model, firth correction will be applied if quasi-complete separation of data points is detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg at Day 29||||=0.903
72559700|NCT01894230|144649481|EQUIVALENCE|Month 8, BMQ Concerns|Slope|-1.0083|STANDARD_ERROR_OF_MEAN|0.737||0.1739|TWO_SIDED||||||Regression, Linear|||||||0.1739
72442327|NCT04714320|144397613|SUPERIORITY||||||=|0.268||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure are included in Logistic Regression model, firth correction will be applied if quasi-complete separation of data points is detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg at Day 29||||=0.268
72442328|NCT04714320|144397613|SUPERIORITY||||||=|0.702||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg at Day 36||||=0.702
72442329|NCT04714320|144397613|SUPERIORITY||||||=|0.885||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg at Day 36||||=0.885
72442330|NCT04714320|144397613|SUPERIORITY||||||=|0.066||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg at Day 43||||=0.066
72442331|NCT04714320|144397613|SUPERIORITY||||||=|0.783||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg at Day 43||||=0.783
72442332|NCT04714320|144397613|SUPERIORITY||||||=|0.456||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg at Day 50||||=0.456
72442333|NCT04714320|144397613|SUPERIORITY||||||=|0.102||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg at Day 50||||=0.102
72442334|NCT04714320|144397613|SUPERIORITY||||||=|0.668||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg at Day 57||||=0.668
72496403|NCT01727258|144522640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.18|STANDARD_ERROR_OF_MEAN|1.183||0.881|TWO_SIDED|95.0|-2.16|2.52||The significance threshold level was 0.05 (two-sided). Family-wise error was controlled at 0.05.|ANCOVA|Terms included treatment and baseline mean tactile sensitivity (Yeaple probe) score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||2.52|-2.16|0.881
72504765|NCT03114969|144540504|SUPERIORITY||Odds Ratio (OR)|2.037||||0.081|TWO_SIDED|95.0|0.916|4.528||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Incruse/Anoro Ellipta as comparator.|||4.528|0.916|0.081
72619056|NCT01755156|144768804|SUPERIORITY_OR_OTHER||Between-group rate difference (%)|4.2||||0.164|TWO_SIDED|95.0|-1.8|10.5|||Miettinen & Nurminen method|||||10.5|-1.8|0.164
72619057|NCT01755156|144768807|SUPERIORITY_OR_OTHER||Difference in least squares means|-27.8||||0.001|TWO_SIDED|95.0|-44.8|-10.8|||cLDA|Based on a cLDA method with a restriction of the same baseline mean.||||-10.8|-44.8|0.001
72619058|NCT01755156|144768808|SUPERIORITY_OR_OTHER||Difference in least squares means|3.7||||0.025|TWO_SIDED|95.0|0.5|6.9|||cLDA|Based on a cLDA method with a restriction of the same baseline mean.||||6.9|0.5|0.025
72442335|NCT04714320|144397613|SUPERIORITY||||||=|0.454||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg at Day 57||||=0.454
72442336|NCT04714320|144397613|SUPERIORITY||||||=|0.044||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg at Day 64||||=0.044
72442337|NCT04714320|144397613|SUPERIORITY||||||=|0.704||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg at Day 64||||=0.704
72442338|NCT04714320|144397613|SUPERIORITY||||||=|0.878||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg at Day 71||||=0.878
72442339|NCT04714320|144397613|SUPERIORITY||||||=|0.681||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg at Day 71||||=0.681
72442340|NCT04714320|144397613|SUPERIORITY||||||=|0.199||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg at Day 78||||=0.199
72442341|NCT04714320|144397613|SUPERIORITY||||||=|0.602||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg at Day 78||||=0.602
72559701|NCT02488109|144649507|OTHER|||||||0.42||||||Changes in rates of clinical remission by group over time in the mITT model.|Regression, Linear|Clinical remission was modeled as a nominal multinomial outcome (yes, no, or missing)||The study was powered to detect a difference in 12-months clinical remission rates between groups. N = 60 per arm with 85% retention would provide 80% power on a 2-sided 0.05-level test to detect a 20% difference between groups in 12-months clinical remission rates. A generalized linear mixed-effects regression model was used to compare study arms with respect to achievement and maintenance of clinical remission.||||0.42
72619059|NCT01755156|144768810|SUPERIORITY_OR_OTHER||Kaplan-Meier difference %|-1.2||||0.654|TWO_SIDED|95.0|-7.0|4.7|||Log Rank|||||4.7|-7.0|0.654
72619060|NCT00090402|144768814|SUPERIORITY_OR_OTHER|||||||0.83|TWO_SIDED|95.0|||||Regression, Linear|Adjusted for age and body mass index||||||0.83
72619061|NCT00292370|144768847|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05|||||||Mixed Models Analysis|||||||<0.05
72619062|NCT03777176|144768868|SUPERIORITY|The negative binomial regression used region and treatment group as fixed effects, and Baseline hypoglycemic rate as covariate and number of hypoglycemic events during Weeks 2-4 as dependent variable.|Event rate ratio|0.85||||0.5028|TWO_SIDED|95.0|0.54|1.36|||Negative binomial regression|||The primary analysis was performed as a negative binominal regression analysis on the difference of the SMPG-detected hypoglycemia episode rate between treatment groups over the Weeks 2-4.||1.36|0.54|0.5028
72619063|NCT03777176|144768869|SUPERIORITY||Mean Difference (Net)|0.84||||0.6433|TWO_SIDED|95.0|-2.71|4.39||The P value should be interpreted with caution given the procedural issues (hypoglycemia at the beginning of the test, test meals not being the same, and some children only having 1 test) which affected the preplanned statistical evaluation.|ANCOVA|||||4.39|-2.71|0.6433
72388293|NCT01786668|144284412|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.47|STANDARD_ERROR_OF_MEAN|0.373||0.214|TWO_SIDED|95.0|-1.2|0.27|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 12||0.27|-1.20|0.214
72388294|NCT01786668|144284412|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.96|STANDARD_ERROR_OF_MEAN|0.372||0.011|TWO_SIDED|95.0|-1.69|-0.22|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 12||-0.22|-1.69|0.011
72388295|NCT01786668|144284412|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.81|STANDARD_ERROR_OF_MEAN|0.375||0.031|TWO_SIDED|95.0|-1.55|-0.08|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 12||-0.08|-1.55|0.031
72388296|NCT01786668|144284413|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.106||0.982|TWO_SIDED|95.0|-0.21|0.21|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 2||0.21|-0.21|0.982
72388297|NCT01786668|144284413|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.15|STANDARD_ERROR_OF_MEAN|0.106||0.151|TWO_SIDED|95.0|-0.36|0.06|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 2||0.06|-0.36|0.151
72388298|NCT01786668|144284413|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.13|STANDARD_ERROR_OF_MEAN|0.106||0.205|TWO_SIDED|95.0|-0.34|0.07|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 2||0.07|-0.34|0.205
72388299|NCT01786668|144284413|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.118||0.898|TWO_SIDED|95.0|-0.25|0.22|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 4||0.22|-0.25|0.898
72388300|NCT01786668|144284413|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.11|STANDARD_ERROR_OF_MEAN|0.118||0.37|TWO_SIDED|95.0|-0.34|0.13|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 4||0.13|-0.34|0.370
72388301|NCT01786668|144284413|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.13|STANDARD_ERROR_OF_MEAN|0.119||0.288|TWO_SIDED|95.0|-0.36|0.11|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 4||0.11|-0.36|0.288
72388302|NCT01786668|144284413|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.16|STANDARD_ERROR_OF_MEAN|0.135||0.242|TWO_SIDED|95.0|-0.42|0.11|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 8||0.11|-0.42|0.242
72388303|NCT01786668|144284413|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.21|STANDARD_ERROR_OF_MEAN|0.135||0.12|TWO_SIDED|95.0|-0.48|0.06|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 8||0.06|-0.48|0.120
72388304|NCT01786668|144284413|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.136||0.031|TWO_SIDED|95.0|-0.56|-0.03|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 8||-0.03|-0.56|0.031
72388305|NCT01786668|144284413|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.17|STANDARD_ERROR_OF_MEAN|0.157||0.28|TWO_SIDED|95.0|-0.48|0.14|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 12||0.14|-0.48|0.280
72388306|NCT01786668|144284413|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.26|STANDARD_ERROR_OF_MEAN|0.157||0.099|TWO_SIDED|95.0|-0.57|0.05|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 12||0.05|-0.57|0.099
72388307|NCT01786668|144284413|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.39|STANDARD_ERROR_OF_MEAN|0.158||0.014|TWO_SIDED|95.0|-0.7|-0.08|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 12||-0.08|-0.70|0.014
72442342|NCT04714320|144397613|SUPERIORITY||||||=|0.135||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg at Day 85||||=0.135
72442343|NCT04714320|144397613|SUPERIORITY||||||=|0.407||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg at Day 85||||=0.407
72442344|NCT04714320|144397613|SUPERIORITY||||||=|0.795||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg at Day 92||||=0.795
72442345|NCT04714320|144397613|SUPERIORITY||||||=|0.036||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg at Day 92||||=0.036
72442346|NCT04714320|144397613|SUPERIORITY||||||=|0.915||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg at Day 106||||=0.915
72442347|NCT04714320|144397613|SUPERIORITY||||||=|0.957||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg at Day 106||||=0.957
72442348|NCT04714320|144397613|SUPERIORITY||||||=|0.804||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg at Day 120||||=0.804
72496404|NCT01727258|144522640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.91|STANDARD_ERROR_OF_MEAN|1.182|<|0.001|TWO_SIDED|95.0|3.57|8.24||Significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline mean tactile sensitivity (Yeaple probe) score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||8.24|3.57|<0.001
72496405|NCT01727258|144522641|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.72|STANDARD_ERROR_OF_MEAN|2.866||0.02|TWO_SIDED|95.0|-12.38|-1.05||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline mean tactile sensitivity VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-1.05|-12.38|0.020
72496406|NCT01727258|144522641|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.13|STANDARD_ERROR_OF_MEAN|2.86||0.964|TWO_SIDED|95.0|-5.52|5.78||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline mean tactile sensitivity VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||5.78|-5.52|0.964
72496407|NCT01727258|144522641|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.85|STANDARD_ERROR_OF_MEAN|2.845||0.017|TWO_SIDED|95.0|-12.47|-1.23||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline mean tactile sensitivity VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-1.23|-12.47|0.017
72619064|NCT03777176|144768870|SUPERIORITY||Mean Difference (Net)|0.15||||0.9653|TWO_SIDED|95.0|-6.48|6.78||There was 1 missing value at Baseline for the dasiglucagon + standard of care group.|ANCOVA|||||6.78|-6.48|0.9653
72442349|NCT04714320|144397613|SUPERIORITY||||||=|0.775||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg at Day 120||||=0.775
72442350|NCT04714320|144397613|SUPERIORITY||||||=|0.801||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg at Day 148||||=0.801
72442351|NCT04714320|144397613|SUPERIORITY||||||=|0.329||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg at Day 148||||=0.329
72442352|NCT04714320|144397613|SUPERIORITY||||||=|0.882||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg at Day 169||||=0.882
72442353|NCT04714320|144397613|SUPERIORITY||||||=|0.235||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg at Day 169||||=0.235
72442354|NCT04714320|144397613|SUPERIORITY||||||=|0.505||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 90 mmHg at Day 8||||=0.505
72442355|NCT04714320|144397613|SUPERIORITY||||||=|0.436||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 90 mmHg at Day 8||||=0.436
72442356|NCT04714320|144397613|SUPERIORITY||||||=|0.637||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 90 mmHg at Day 15||||=0.637
72442357|NCT04714320|144397613|SUPERIORITY||||||=|0.254||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 90 mmHg at Day 15||||=0.254
72442358|NCT04714320|144397613|SUPERIORITY||||||=|0.848||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 90 mmHg at Day 22||||=0.848
72442359|NCT04714320|144397613|SUPERIORITY||||||=|0.24||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 90 mmHg at Day 22||||=0.240
72496408|NCT01727258|144522642|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.92|STANDARD_ERROR_OF_MEAN|3.327||0.039|TWO_SIDED|95.0|-13.5|-0.35||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline mean tactile sensitivity VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-0.35|-13.50|0.039
72496409|NCT01727258|144522642|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.06|STANDARD_ERROR_OF_MEAN|3.317||0.13|TWO_SIDED|95.0|-1.5|11.61||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline mean tactile sensitivity VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||11.61|-1.50|0.130
72559702|NCT02488109|144649508|SUPERIORITY||Hazard Ratio (HR)|1.67||||0.01|TWO_SIDED|95.0|1.1|2.53||Survival analysis of time to medical stability by log-rank test, which does not assume proportional hazards. Those who did not reach medical stability before hospital discharge were censored; analyses accounted for the site effect by stratification.|Survival analysis with log rank test|Compared time to achieve medical stability by arm; participants who did not meet stability criteria by hospital discharge were right-censored||This trial was powered at 0.80 to detect a 12% to 20% difference in restored medical stability at 0.05 type I error and correlation between time points from 0.1 to 1.||2.53|1.10|0.01
72559703|NCT02488109|144649509|SUPERIORITY||Median Difference (Net)|19.0||||0.002|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||Cost outcomes of group differences and 95% confidence intervals were estimated.||28,819|9,293|0.002
72559704|NCT03969641|144649510|NON_INFERIORITY|This objective will be assessed using a one-sided noninferiority test with the alpha level set at 0.025 (1-sided) and a noninferiority margin of 10%.|Difference in Proportions (RIV4 - IIV4)|-0.0214|||<|0.0001|ONE_SIDED|97.5||0.0406|||Cochran-Mantel-Haenszel|The upper bound of a Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting of the difference was used, stratified by site.|The directional comparison was the upper bound of the confidence interval using a 10% noninferiority margin.|The null hypothesis assumes that RIV4 is inferior (i.e., RIV4 will have a higher proportion) to IIV4 in regards to the proportion of pregnant women with adverse birth outcomes.||0.0406||<0.0001
72559705|NCT03969641|144649511|SUPERIORITY|This proportion was compared between the RIV4 group and the IIV4 group using an exact Mantel-Haenszel statistic (calculated in Proc Logistic in SAS) in a stratified analysis by site to control for the randomization blocks at the two-sided alpha 0.05 level. The site adjusted odds ratio and corresponding 95% confidence interval for the proportion of preterm birth was also calculated.|Odds Ratio (OR)|0.72||||0.4645|TWO_SIDED|95.0|0.35|1.48|||Mantel Haenszel|||Preterm birth||1.48|0.35|0.4645
72619065|NCT03777176|144768871|SUPERIORITY||Event rate ratio|0.93||||0.8114|TWO_SIDED|95.0|0.49|1.74|||Negative binominal regression|The negative binomial regression used region and treatment group as fixed effects, and Baseline hypoglycemic rate as covariate.||||1.74|0.49|0.8114
72496410|NCT01727258|144522642|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.98|STANDARD_ERROR_OF_MEAN|3.313|<|0.001|TWO_SIDED|95.0|-18.53|-5.43||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline mean tactile sensitivity VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-5.43|-18.53|<0.001
72442360|NCT04714320|144397613|SUPERIORITY||||||=|0.382||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 90 mmHg at Day 29||||=0.382
72442361|NCT04714320|144397613|SUPERIORITY||||||=|0.935||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 90 mmHg at Day 29||||=0.935
72442362|NCT04714320|144397613|SUPERIORITY||||||=|0.278||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 90 mmHg at Day 36||||=0.278
72442363|NCT04714320|144397613|SUPERIORITY||||||=|0.211||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 90 mmHg at Day 36||||=0.211
72388308|NCT01786668|144284414|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.387||0.895|TWO_SIDED|95.0|-0.81|0.71|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 4||0.71|-0.81|0.895
72388309|NCT01786668|144284414|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.83|STANDARD_ERROR_OF_MEAN|0.386||0.033|TWO_SIDED|95.0|-1.59|-0.07|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 4||-0.07|-1.59|0.033
72388310|NCT01786668|144284414|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.79|STANDARD_ERROR_OF_MEAN|0.388||0.044|TWO_SIDED|95.0|-1.55|-0.02|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 4||-0.02|-1.55|0.044
72388311|NCT01786668|144284414|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.26|STANDARD_ERROR_OF_MEAN|0.411||0.53|TWO_SIDED|95.0|-1.07|0.55|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 8||0.55|-1.07|0.530
72388312|NCT01786668|144284414|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.65|STANDARD_ERROR_OF_MEAN|0.411||0.114|TWO_SIDED|95.0|-1.46|0.16|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 8||0.16|-1.46|0.114
72388313|NCT01786668|144284414|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.43|STANDARD_ERROR_OF_MEAN|0.415||0.297|TWO_SIDED|95.0|-1.25|0.38|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 8||0.38|-1.25|0.297
72388314|NCT01786668|144284414|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.33|STANDARD_ERROR_OF_MEAN|0.37||0.377|TWO_SIDED|95.0|-1.06|0.4|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 12||0.40|-1.06|0.377
72388315|NCT01786668|144284414|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.04|STANDARD_ERROR_OF_MEAN|0.37||0.006|TWO_SIDED|95.0|-1.77|-0.31|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 12||-0.31|-1.77|0.006
72388316|NCT01786668|144284414|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9|STANDARD_ERROR_OF_MEAN|0.373||0.017|TWO_SIDED|95.0|-1.64|-0.17|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 12||-0.17|-1.64|0.017
72619066|NCT01133977|144768891|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.4|||||TWO_SIDED|95.0|0.23|0.75||||||The current study was not powered or designed to determine superiority of the '20 mg Lenvatinib + Dacarbazine (Phase 2)' arm compared with 'Dacarbazine (Phase 2) ' arm.||0.75|0.23|
72619067|NCT03606213|144768896|OTHER|||||||0.56||||||P-value week 14 versus baseline (Cohort A, arm 1; placebo)|Wilcoxon (Mann-Whitney)|||||||0.56
72388317|NCT01786668|144284416|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.11|STANDARD_ERROR_OF_MEAN|0.414||0.8|TWO_SIDED|95.0|-0.92|0.71|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 2||0.71|-0.92|0.800
72388318|NCT01786668|144284416|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.66|STANDARD_ERROR_OF_MEAN|0.413||0.113|TWO_SIDED|95.0|-0.16|1.47|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 2||1.47|-0.16|0.113
72388319|NCT01786668|144284416|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.77|STANDARD_ERROR_OF_MEAN|0.414||0.064|TWO_SIDED|95.0|-1.59|0.05|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 2||0.05|-1.59|0.064
72388320|NCT01786668|144284416|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.368||0.972|TWO_SIDED|95.0|-0.74|0.71|||Mixed Models Analysis|||Week 4||0.71|-0.74|0.972
72388321|NCT01786668|144284416|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.28|STANDARD_ERROR_OF_MEAN|0.368||0.44|TWO_SIDED|95.0|-0.44|1.01|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 4||1.01|-0.44|0.440
72388322|NCT01786668|144284416|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.37|STANDARD_ERROR_OF_MEAN|0.369||0.311|TWO_SIDED|95.0|-1.1|0.35|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 4||0.35|-1.10|0.311
72388323|NCT01786668|144284416|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.42|STANDARD_ERROR_OF_MEAN|0.629||0.501|TWO_SIDED|95.0|-1.66|0.82|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 8||0.82|-1.66|0.501
72388324|NCT01786668|144284416|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.38|STANDARD_ERROR_OF_MEAN|0.629||0.543|TWO_SIDED|95.0|-1.63|0.86|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 8||0.86|-1.63|0.543
72388325|NCT01786668|144284416|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.68|STANDARD_ERROR_OF_MEAN|0.636||0.287|TWO_SIDED|95.0|-1.93|0.57|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 8||0.57|-1.93|0.287
72388326|NCT01786668|144284416|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.12|STANDARD_ERROR_OF_MEAN|0.519||0.82|TWO_SIDED|95.0|-0.91|1.14|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 12||1.14|-0.91|0.820
72619068|NCT03074643|144768912|SUPERIORITY|||||||0.16|||||||ANCOVA|Adjusted for age, sex, race||||||0.16
72619069|NCT03074643|144768912|SUPERIORITY|||||||0.45|||||||ANCOVA|Adjusted for age, sex, race||||||0.45
72619070|NCT03074643|144768913|SUPERIORITY|||||||0.81|||||||ANCOVA|Adjusted for age, sex, race||||||0.81
72496411|NCT01727258|144522643|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.26|STANDARD_ERROR_OF_MEAN|3.163||0.01|TWO_SIDED|95.0|-14.51|-2.0||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline mean air stimulus VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-2.00|-14.51|0.010
72442364|NCT04714320|144397613|SUPERIORITY||||||=|0.562||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 90 mmHg at Day 43||||=0.562
72442365|NCT04714320|144397613|SUPERIORITY||||||=|0.25||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 90 mmHg at Day 43||||=0.250
72442366|NCT04714320|144397613|SUPERIORITY||||||=|0.114||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 90 mmHg at Day 50||||=0.114
72496412|NCT01727258|144522643|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.26|STANDARD_ERROR_OF_MEAN|3.16||0.179|TWO_SIDED|95.0|-1.98|10.51||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline mean air stimulus VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||10.51|-1.98|0.179
72496413|NCT01727258|144522643|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.52|STANDARD_ERROR_OF_MEAN|3.172|<|0.001|TWO_SIDED|95.0|-18.79|-6.25||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline mean air stimulus VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-6.25|-18.79|<0.001
72496414|NCT01727258|144522644|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.93|STANDARD_ERROR_OF_MEAN|3.543|<|0.001|TWO_SIDED|95.0|-18.93|-4.93||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline mean air stimulus VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-4.93|-18.93|<0.001
72496415|NCT01727258|144522644|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.54|STANDARD_ERROR_OF_MEAN|3.534||0.119|TWO_SIDED|95.0|-1.44|12.53||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline mean air stimulus VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||12.53|-1.44|0.119
72496416|NCT01727258|144522644|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.47|STANDARD_ERROR_OF_MEAN|3.566|<|0.001|TWO_SIDED|95.0|-24.52|-10.42||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline mean air stimulus VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-10.42|-24.52|<0.001
72496417|NCT01960855|144522645|OTHER||||||=|0.033|||||||Chi-squared|||||||= 0.033
72559706|NCT03969641|144649512|SUPERIORITY|These proportions were compared between the RIV4 group and the IIV4 group using an exact Mantel-Haenszel statistic (calculated in Proc Logistic in SAS) in a stratified analysis by site to control for the randomization blocks at the two-sided alpha 0.05 level. The site adjusted odds ratio and corresponding 95% confidence interval for the proportions of combined fetal death and neonatal death was also calculated.|Odds Ratio (OR)|0.00000031||||0.2447|TWO_SIDED|95.0|0.0||The upper limit of this CI is infinity, thus no numeric value can be provided.||Mantel Haenszel|||Fetal or neonatal death|||0.00|0.2447
72496418|NCT01960855|144522645|OTHER||||||=|0.004|||||||Chi-squared|||||||= 0.004
72559707|NCT03969641|144649513|SUPERIORITY|This proportion was compared between the RIV4 group and the IIV4 group using an exact Mantel-Haenszel statistic in a stratified analysis by site to control for the randomization blocks at the two-sided alpha 0.05 level. The site adjusted odds ratio and corresponding 95% confidence interval for the proportion of spontaneous abortion after vaccination was also calculated. This was a subgroup analysis of only those participants vaccinated at less than 20 weeks gestational age.|Odds Ratio (OR)|0.5||||0.6235|TWO_SIDED|95.0|0.04|5.47|||Mantel Haenszel|||Spontaneous abortion||5.47|0.04|0.6235
72496419|NCT01960855|144522645|OTHER||||||<|0.001|||||||Chi-squared|||||||< 0.001
72619071|NCT03074643|144768913|SUPERIORITY|||||||0.8|||||||ANCOVA|Adjusted for age, sex, race||||||0.80
72619072|NCT03074643|144768914|SUPERIORITY|||||||0.56|||||||ANCOVA|Adjusted for age, sex, race||||||0.56
72619073|NCT03074643|144768914|SUPERIORITY|||||||0.96|||||||ANCOVA|Adjusted for age, sex, race||||||0.96
72442367|NCT04714320|144397613|SUPERIORITY||||||=|0.55||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 90 mmHg at Day 50||||=0.550
72442368|NCT04714320|144397613|SUPERIORITY||||||=|0.423||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 90 mmHg at Day 57||||=0.423
72496420|NCT01960855|144522645|OTHER||||||<|0.001|||||||Chi-squared|||||||< 0.001
72496421|NCT01960855|144522646|OTHER||||||=|0.364|||||||Chi-squared|||||||= 0.364
72496422|NCT01960855|144522646|OTHER||||||=|0.014|||||||Chi-squared|||||||= 0.014
72496423|NCT01960855|144522646|OTHER||||||=|0.003|||||||Chi-squared|||||||= 0.003
72496424|NCT01960855|144522646|OTHER||||||=|0.008|||||||Chi-squared|||||||= 0.008
72496425|NCT01960855|144522647|OTHER||||||=|0.093|||||||Chi-squared|||||||= 0.093
72496426|NCT01960855|144522647|OTHER||||||<|0.001|||||||Chi-squared|||||||< 0.001
72559708|NCT03969641|144649514|SUPERIORITY|These proportions will be compared between the RIV4 group and the IIV4 group, within symptom, using an exact Mantel-Haenszel statistic (calculated in Proc Logistic in SAS) in a stratified analysis by site to control for the randomization blocks at the two-sided alpha 0.05 level.|Odds Ratio (OR)|1.17||||0.7029|TWO_SIDED|95.0|0.55|2.5|||Mantel Haenszel|||Injection Site Pain||2.50|0.55|0.7029
72388327|NCT01786668|144284416|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.19|STANDARD_ERROR_OF_MEAN|0.52||0.711|TWO_SIDED|95.0|-0.83|1.22|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 12||1.22|-0.83|0.711
72496427|NCT01960855|144522647|OTHER||||||=|0.004|||||||Chi-squared|||||||= 0.004
72496428|NCT01960855|144522647|OTHER||||||=|0.004|||||||Chi-squared|||||||= 0.004
72496429|NCT01960855|144522648|OTHER||||||=|0.366|||||||Chi-squared|||||||= 0.366
72496430|NCT01960855|144522648|OTHER||||||=|0.17|||||||Chi-squared|||||||= 0.17
72496431|NCT01960855|144522648|OTHER||||||=|0.003|||||||Chi-squared|||||||= 0.003
72496432|NCT01960855|144522648|OTHER||||||=|0.028|||||||Chi-squared|||||||= 0.028
72496433|NCT01960855|144522649|OTHER||||||=|0.126|||||||Chi-squared|||||||= 0.126
72496434|NCT01960855|144522649|OTHER||||||=|0.072|||||||Chi-squared|||||||= 0.072
72559709|NCT03969641|144649514|SUPERIORITY|These proportions will be compared between the RIV4 group and the IIV4 group, within symptom, using an exact Mantel-Haenszel statistic (calculated in Proc Logistic in SAS) in a stratified analysis by site to control for the randomization blocks at the two-sided alpha 0.05 level.|Odds Ratio (OR)|2.03||||0.6217|TWO_SIDED|95.0|0.18|22.52|||Mantel Haenszel|||Injection Site Redness||22.52|0.18|0.6217
72619074|NCT03074643|144768915|SUPERIORITY|||||||0.76|||||||ANCOVA|Adjusted for age, sex, race||||||0.76
72388328|NCT01786668|144284416|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.42|STANDARD_ERROR_OF_MEAN|0.524||0.424|TWO_SIDED|95.0|-1.45|0.61|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 12||0.61|-1.45|0.424
72388329|NCT01786668|144284417|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.06|STANDARD_ERROR_OF_MEAN|0.203||0.785|TWO_SIDED|95.0|-0.34|0.46|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 2||0.46|-0.34|0.785
72388330|NCT01786668|144284417|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.11|STANDARD_ERROR_OF_MEAN|0.203||0.605|TWO_SIDED|95.0|-0.3|0.51|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 2||0.51|-0.30|0.605
72388331|NCT01786668|144284417|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.28|STANDARD_ERROR_OF_MEAN|0.204||0.175|TWO_SIDED|95.0|-0.68|0.12|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 2||0.12|-0.68|0.175
72388332|NCT01786668|144284417|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.16|STANDARD_ERROR_OF_MEAN|0.232||0.482|TWO_SIDED|95.0|-0.29|0.62|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 4||0.62|-0.29|0.482
72388333|NCT01786668|144284417|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.25|STANDARD_ERROR_OF_MEAN|0.231||0.288|TWO_SIDED|95.0|-0.7|0.21|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 4||0.21|-0.70|0.288
72388334|NCT01786668|144284417|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.25|STANDARD_ERROR_OF_MEAN|0.233||0.278|TWO_SIDED|95.0|-0.71|0.21|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 4||0.21|-0.71|0.278
72388335|NCT01786668|144284417|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.38|STANDARD_ERROR_OF_MEAN|0.254||0.134|TWO_SIDED|95.0|-0.12|0.88|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 8||0.88|-0.12|0.134
72496435|NCT01960855|144522649|OTHER||||||=|0.012|||||||Chi-squared|||||||= 0.012
72496436|NCT01960855|144522649|OTHER||||||=|0.021|||||||Chi-squared|||||||= 0.021
72496437|NCT02058147|144522650|SUPERIORITY_OR_OTHER||Least Square (LS) Mean Difference|-0.78|STANDARD_ERROR_OF_MEAN|0.059|<|0.0001|TWO_SIDED|95.0|-0.898|-0.665||Threshold for significance ≤0.05.|Mixed Models Analysis||Insulin Glargine/Lixisenatide FRC vs Lixisenatide|Analysis was performed using Mixed-effect model with repeated measures (MMRM) with treatment groups, randomization strata of Week -1 HbA1c (\<8.0, ≥8.0%), randomization strata of second OAD use at screening, visits, treatment-by-visit interaction, and country as fixed effects and baseline HbA1c value-by-visit interaction as a covariate.||-0.665|-0.898|<0.0001
72496438|NCT02058147|144522650|NON_INFERIORITY_OR_EQUIVALENCE|Predefined non-inferiority margin of 0.3%.|LS Mean Difference|-0.29|STANDARD_ERROR_OF_MEAN|0.048|||TWO_SIDED|95.0|-0.384|-0.194|||Mixed Models Analysis||Insulin Glargine/Lixisenatide FRC vs Insulin glargine|Analysis was performed using MMRM model with treatment groups, randomization strata of Week -1 HbA1c (\<8.0, ≥8.0%), randomization strata of second OAD use at screening, visits, treatment-by-visit interaction, and country as fixed effects and baseline HbA1c value-by-visit interaction as a covariate.||-0.194|-0.384|
72496439|NCT02058147|144522650|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.29|STANDARD_ERROR_OF_MEAN|0.048|<|0.0001|TWO_SIDED|95.0|-0.384|-0.194||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Insulin Glargine/Lixisenatide FRC vs Insulin glargine|Test of superiority was also performed as a secondary endpoint according to hierarchical testing procedure. Analysis was performed using MMRM model with treatment groups, randomization strata of Week -1 HbA1c (\<8.0, ≥8.0%), randomization strata of second OAD use at screening, visits, treatment-by-visit interaction, and country as fixed effects and baseline HbA1c value-by-visit interaction, as a covariate.||-0.194|-0.384|<0.0001
72496440|NCT02058147|144522651|SUPERIORITY_OR_OTHER||Difference in percentage|40.61|||<|0.0001|TWO_SIDED|95.0|33.63|47.59||Threshold for significance ≤0.05.|Cochran-Mantel-Haenszel||HbA1c \<7.0%: Insulin Glargine/Lixisenatide FRC vs Lixisenatide.|"HbA1c \<7.0%: Insulin Glargine/Lixisenatide FRC vs Lixisenatide.~Analysis was performed using Cochran-Mantel-Haenszel method stratified on randomization strata of Week -1 HbA1c (\<8.0%, ≥8.0%) and randomization strata of second OAD use at screening. This analysis was out of testing order."||47.59|33.63|<0.0001
72559710|NCT03969641|144649514|SUPERIORITY|These proportions will be compared between the RIV4 group and the IIV4 group, within symptom, using an exact Mantel-Haenszel statistic (calculated in Proc Logistic in SAS) in a stratified analysis by site to control for the randomization blocks at the two-sided alpha 0.05 level.|Odds Ratio (OR)|0.7||||0.3848|TWO_SIDED|95.0|0.35|1.39|||Mantel Haenszel|||Injection Site Tenderness||1.39|0.35|0.3848
72559711|NCT03969641|144649514|SUPERIORITY|These proportions will be compared between the RIV4 group and the IIV4 group, within symptom, using an exact Mantel-Haenszel statistic (calculated in Proc Logistic in SAS) in a stratified analysis by site to control for the randomization blocks at the two-sided alpha 0.05 level.|Odds Ratio (OR)|0.53||||0.2504|TWO_SIDED|95.0|0.21|1.35|||Mantel Haenszel|||Nausea||1.35|0.21|0.2504
72559712|NCT03969641|144649514|SUPERIORITY|These proportions will be compared between the RIV4 group and the IIV4 group, within symptom, using an exact Mantel-Haenszel statistic (calculated in Proc Logistic in SAS) in a stratified analysis by site to control for the randomization blocks at the two-sided alpha 0.05 level.|Odds Ratio (OR)|0.62||||0.5751|TWO_SIDED|95.0|0.2|1.93|||Mantel Haenszel|||Vomiting||1.93|0.20|0.5751
72559713|NCT03969641|144649514|SUPERIORITY|These proportions will be compared between the RIV4 group and the IIV4 group, within symptom, using an exact Mantel-Haenszel statistic (calculated in Proc Logistic in SAS) in a stratified analysis by site to control for the randomization blocks at the two-sided alpha 0.05 level.|Odds Ratio (OR)|1.01||||1|TWO_SIDED|95.0|0.32|3.19|||Mantel Haenszel|||Diarrhea||3.19|0.32|1.0000
72559714|NCT03969641|144649514|SUPERIORITY|These proportions will be compared between the RIV4 group and the IIV4 group, within symptom, using an exact Mantel-Haenszel statistic (calculated in Proc Logistic in SAS) in a stratified analysis by site to control for the randomization blocks at the two-sided alpha 0.05 level.|Odds Ratio (OR)|0.8||||1|TWO_SIDED|95.0|0.21|3.04|||Mantel Haenszel|||Abdominal Pain||3.04|0.21|1.0000
72559715|NCT03969641|144649514|SUPERIORITY|These proportions will be compared between the RIV4 group and the IIV4 group, within symptom, using an exact Mantel-Haenszel statistic (calculated in Proc Logistic in SAS) in a stratified analysis by site to control for the randomization blocks at the two-sided alpha 0.05 level.|Odds Ratio (OR)|0.53||||0.1326|TWO_SIDED|95.0|0.25|1.13|||Mantel Haenszel|||Headache||1.13|0.25|0.1326
72559716|NCT03969641|144649514|SUPERIORITY|These proportions will be compared between the RIV4 group and the IIV4 group, within symptom, using an exact Mantel-Haenszel statistic (calculated in Proc Logistic in SAS) in a stratified analysis by site to control for the randomization blocks at the two-sided alpha 0.05 level.|Odds Ratio (OR)|1.01||||1|TWO_SIDED|95.0|0.2|5.04|||Mantel Haenszel|||Chills/Shivering||5.04|0.20|1.0000
72559717|NCT03969641|144649514|SUPERIORITY|These proportions will be compared between the RIV4 group and the IIV4 group, within symptom, using an exact Mantel-Haenszel statistic (calculated in Proc Logistic in SAS) in a stratified analysis by site to control for the randomization blocks at the two-sided alpha 0.05 level.|Odds Ratio (OR)|0.0||||1|TWO_SIDED|95.0|0.0||The upper limit of this CI is infinity, thus no numeric value can be provided.||Mantel Haenszel|||Body Rash|||0.00|1.0000
72559718|NCT03969641|144649514|SUPERIORITY|These proportions will be compared between the RIV4 group and the IIV4 group, within symptom, using an exact Mantel-Haenszel statistic (calculated in Proc Logistic in SAS) in a stratified analysis by site to control for the randomization blocks at the two-sided alpha 0.05 level.|Odds Ratio (OR)|0.92||||1|TWO_SIDED|95.0|0.39|2.15|||Mantel Haenszel|||Malaise (Fatigue)||2.15|0.39|1.0000
72619075|NCT03074643|144768915|SUPERIORITY|||||||0.45|||||||ANCOVA|Adjusted for age, sex, race||||||0.45
72619076|NCT03074643|144768916|SUPERIORITY|||||||0.75|||||||ANCOVA|Adjusted for age, sex, race||||||0.75
72388336|NCT01786668|144284417|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.22|STANDARD_ERROR_OF_MEAN|0.254||0.397|TWO_SIDED|95.0|-0.29|0.72|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 8||0.72|-0.29|0.397
72388337|NCT01786668|144284417|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.257||0.964|TWO_SIDED|95.0|-0.5|0.52|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 8||0.52|-0.50|0.964
72388338|NCT01786668|144284417|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.38|STANDARD_ERROR_OF_MEAN|0.269||0.155|TWO_SIDED|95.0|-0.15|0.91|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 12||0.91|-0.15|0.155
72388339|NCT01786668|144284417|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.19|STANDARD_ERROR_OF_MEAN|0.269||0.491|TWO_SIDED|95.0|-0.34|0.72|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 12||0.72|-0.34|0.491
72388340|NCT01786668|144284417|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.18|STANDARD_ERROR_OF_MEAN|0.271||0.515|TWO_SIDED|95.0|-0.71|0.36|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 12||0.36|-0.71|0.515
72388341|NCT01786668|144284418|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.65|STANDARD_ERROR_OF_MEAN|1.312||0.006|TWO_SIDED|95.0|1.06|6.24|||ANCOVA|ANCOVA model includes fixed effects for treatment group and baseline value as a covariate.||Physical Health Score||6.24|1.06|0.006
72388342|NCT01786668|144284418|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.8|STANDARD_ERROR_OF_MEAN|1.305||0.004|TWO_SIDED|95.0|1.23|6.37|||ANCOVA|ANCOVA model includes fixed effects for treatment group and baseline value as a covariate.||Physical Health Score||6.37|1.23|0.004
72388343|NCT01786668|144284418|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.36|STANDARD_ERROR_OF_MEAN|1.328||0.001|TWO_SIDED|95.0|1.74|6.98|||ANCOVA|ANCOVA model includes fixed effects for treatment group and baseline value as a covariate.||Physical Health Score||6.98|1.74|0.001
72388344|NCT01786668|144284418|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.34|STANDARD_ERROR_OF_MEAN|1.857||0.857|TWO_SIDED|95.0|-4.0|3.33|||ANCOVA|ANCOVA model includes fixed effects for treatment group and baseline value as a covariate.||Mental Health Score||3.33|-4.00|0.857
72388345|NCT01786668|144284418|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.73|STANDARD_ERROR_OF_MEAN|1.848||0.35|TWO_SIDED|95.0|-1.91|5.37|||ANCOVA|ANCOVA model includes fixed effects for treatment group and baseline value as a covariate.||Mental Health Score||5.37|-1.91|0.350
72442369|NCT04714320|144397613|SUPERIORITY||||||=|0.422||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 90 mmHg at Day 57||||=0.422
72442370|NCT04714320|144397613|SUPERIORITY||||||=|0.073||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 90 mmHg at Day 64||||=0.073
72442371|NCT04714320|144397613|SUPERIORITY||||||=|0.278||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 90 mmHg at Day 64||||=0.278
72442372|NCT04714320|144397613|SUPERIORITY||||||=|0.338||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 90 mmHg at Day 71||||=0.338
72442373|NCT04714320|144397613|SUPERIORITY||||||=|0.969||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 90 mmHg at Day 71||||=0.969
72442374|NCT04714320|144397613|SUPERIORITY||||||=|0.489||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 90 mmHg at Day 78||||=0.489
72442375|NCT04714320|144397613|SUPERIORITY||||||=|0.156||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 90 mmHg at Day 78||||=0.156
72442376|NCT04714320|144397613|SUPERIORITY||||||=|0.389||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 90 mmHg at Day 85||||=0.389
72442377|NCT04714320|144397613|SUPERIORITY||||||=|0.775||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 90 mmHg at Day 85||||=0.775
72442378|NCT04714320|144397613|SUPERIORITY||||||=|0.437||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 90 mmHg at Day 92||||=0.437
72442379|NCT04714320|144397613|SUPERIORITY||||||=|0.618|||||||Regression, Logistic|||Seated Automated Office DBP ≤ 90 mmHg at Day 92||||=0.618
72559719|NCT03969641|144649514|SUPERIORITY|These proportions will be compared between the RIV4 group and the IIV4 group, within symptom, using an exact Mantel-Haenszel statistic (calculated in Proc Logistic in SAS) in a stratified analysis by site to control for the randomization blocks at the two-sided alpha 0.05 level.|Odds Ratio (OR)|0.87||||1|TWO_SIDED|95.0|0.31|2.48|||Mantel Haenszel|||Myalgia (Body Aches)||2.48|0.31|1.0000
72559720|NCT03969641|144649514|SUPERIORITY||Odds Ratio (OR)|0.71||||0.7704|TWO_SIDED|95.0|0.22|2.29|||Mantel Haenszel|||Joint Pain||2.29|0.22|0.7704
72442380|NCT04714320|144397613|SUPERIORITY||||||=|0.079||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 90 mmHg at Day 106||||=0.079
72442381|NCT04714320|144397613|SUPERIORITY||||||=|0.349||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 90 mmHg at Day 106||||=0.349
72442382|NCT04714320|144397613|SUPERIORITY||||||=|0.58||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 90 mmHg at Day 120||||=0.580
72442383|NCT04714320|144397613|SUPERIORITY||||||=|0.106||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 90 mmHg at Day 120||||=0.106
72442384|NCT04714320|144397613|SUPERIORITY||||||=|0.955||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 90 mmHg at Day 148||||=0.955
72442385|NCT04714320|144397613|SUPERIORITY||||||=|0.134||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 90 mmHg at Day 148||||=0.134
72619077|NCT03074643|144768916|SUPERIORITY|||||||0.95|||||||ANCOVA|Adjusted for age, sex, race||||||0.95
72619078|NCT03074643|144768917|SUPERIORITY|||||||0.06|||||||ANCOVA|Adjusted for age, sex, race||||||0.06
72619079|NCT03074643|144768917|SUPERIORITY|||||||0.22|||||||ANCOVA|Adjusted for age, sex, race||||||0.22
72619080|NCT03074643|144768918|SUPERIORITY|||||||0.48|||||||ANCOVA|Adjusted for age, sex, race||||||0.48
72619081|NCT03074643|144768918|SUPERIORITY|||||||0.22|||||||ANCOVA|Adjusted for age, sex, race||||||0.22
72619082|NCT01750281|144768922|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|A hazard ratio \<1 favours selumetinib in combination with docetaxel|Hazard Ratio (HR)|1.12||||0.584|TWO_SIDED|90.0|0.8|1.61|||Cox Proportional Hazards|||||1.61|0.80|0.584
72388346|NCT01786668|144284418|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.3|STANDARD_ERROR_OF_MEAN|1.876||0.49|TWO_SIDED|95.0|-2.4|5.0|||ANCOVA|ANCOVA model includes fixed effects for treatment group and baseline value as a covariate.||Mental Health Score||5.00|-2.40|0.490
72388347|NCT01786668|144284419|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.07|STANDARD_ERROR_OF_MEAN|0.048||0.125|TWO_SIDED|95.0|-0.02|0.17|||ANCOVA|ANCOVA model includes fixed effects for treatment group and baseline value as a covariate.||||0.17|-0.02|0.125
72388348|NCT01786668|144284419|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.06|STANDARD_ERROR_OF_MEAN|0.048||0.207|TWO_SIDED|95.0|-0.03|0.16|||ANCOVA|ANCOVA model includes fixed effects for treatment group and baseline value as a covariate.||||0.16|-0.03|0.207
72388349|NCT01786668|144284419|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.12|STANDARD_ERROR_OF_MEAN|0.049||0.013|TWO_SIDED|95.0|0.03|0.22|||ANCOVA|ANCOVA model includes fixed effects for treatment group and baseline value as a covariate.||||0.22|0.03|0.013
72388350|NCT01786668|144284420|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.72|STANDARD_ERROR_OF_MEAN|1.232||0.163|TWO_SIDED|95.0|-0.71|4.15|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 2||4.15|-0.71|0.163
72388351|NCT01786668|144284420|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.07|STANDARD_ERROR_OF_MEAN|1.232||0.955|TWO_SIDED|95.0|-2.36|2.5|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 2||2.50|-2.36|0.955
72388352|NCT01786668|144284420|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.27|STANDARD_ERROR_OF_MEAN|1.237||0.826|TWO_SIDED|95.0|-2.17|2.71|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 2||2.71|-2.17|0.826
72388353|NCT01786668|144284420|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.54|STANDARD_ERROR_OF_MEAN|1.322||0.246|TWO_SIDED|95.0|-1.07|4.14|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 4||4.14|-1.07|0.246
72388354|NCT01786668|144284420|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.96|STANDARD_ERROR_OF_MEAN|1.318||0.467|TWO_SIDED|95.0|-1.64|3.56|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 4||3.56|-1.64|0.467
72388355|NCT01786668|144284420|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.09|STANDARD_ERROR_OF_MEAN|1.328||0.948|TWO_SIDED|95.0|-2.53|2.7|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 4||2.70|-2.53|0.948
72388356|NCT01786668|144284420|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.69|STANDARD_ERROR_OF_MEAN|1.479||0.255|TWO_SIDED|95.0|-1.23|4.61|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 8||4.61|-1.23|0.255
72388357|NCT01786668|144284420|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.96|STANDARD_ERROR_OF_MEAN|1.479||0.187|TWO_SIDED|95.0|-0.96|4.87|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 8||4.87|-0.96|0.187
72388358|NCT01786668|144284420|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.34|STANDARD_ERROR_OF_MEAN|1.497||0.373|TWO_SIDED|95.0|-1.62|4.29|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 8||4.29|-1.62|0.373
72388359|NCT01786668|144284420|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.66|STANDARD_ERROR_OF_MEAN|1.643||0.313|TWO_SIDED|95.0|-1.58|4.9|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 12||4.90|-1.58|0.313
72388360|NCT01786668|144284420|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.95|STANDARD_ERROR_OF_MEAN|1.642||0.017|TWO_SIDED|95.0|0.71|7.19|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 12||7.19|0.71|0.017
72388361|NCT01786668|144284420|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.51|STANDARD_ERROR_OF_MEAN|1.66||0.007|TWO_SIDED|95.0|1.23|7.78|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 12||7.78|1.23|0.007
72388362|NCT03570697|144284421|SUPERIORITY||Treatment difference|21.2|STANDARD_ERROR_OF_MEAN|7.9||0.015|TWO_SIDED|95.0|4.7|37.7|||ANCOVA|||||37.7|4.7|0.015
72388363|NCT03570697|144284422|SUPERIORITY||Treatment difference|37.47|STANDARD_ERROR_OF_MEAN|17.04||0.041|TWO_SIDED|95.0|1.63|73.31|||ANCOVA|||||73.31|1.63|0.041
72388364|NCT03570697|144284423|SUPERIORITY||Treatment difference|32.51|STANDARD_ERROR_OF_MEAN|9.52||0.003|TWO_SIDED|95.0|12.67|52.35|||ANCOVA|||||52.35|12.67|0.003
72388365|NCT03570697|144284424|SUPERIORITY||Treatment difference|-26.0|STANDARD_ERROR_OF_MEAN|11.4||0.032|TWO_SIDED|95.0|-49.6|-2.4|||ANCOVA|||||-2.4|-49.6|0.032
72388366|NCT03570697|144284425|SUPERIORITY||Treatment difference|16.0|STANDARD_ERROR_OF_MEAN|7.5||0.036|TWO_SIDED|95.0|1.1|31.0|||ANCOVA|||||31.0|1.1|0.036
72388367|NCT03570697|144284426|SUPERIORITY||Treatment difference|-30.0|STANDARD_ERROR_OF_MEAN|10.4||0.005|TWO_SIDED|95.0|-50.5|-9.5|||ANCOVA|||||-9.5|-50.5|0.005
72388368|NCT03570697|144284427|SUPERIORITY||Treatment difference|-2.43|STANDARD_ERROR_OF_MEAN|0.81||0.003|TWO_SIDED|95.0|-4.04|-0.82|||ANCOVA|||||-0.82|-4.04|0.003
72388369|NCT01776840|144284432|SUPERIORITY||Hazard Ratio (HR)|0.75||||0.011|TWO_SIDED|95.0|0.59|0.96|||Log Rank|||||0.96|0.59|0.011
72442386|NCT04714320|144397613|SUPERIORITY||||||=|0.933||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 90 mmHg at Day 169||||=0.933
72496441|NCT02058147|144522651|SUPERIORITY_OR_OTHER||Difference in percentage|36.38|||<|0.0001|TWO_SIDED|95.0|29.81|42.95||Threshold for significance ≤ 0.05.|Cochran-Mantel-Haenszel||HbA1c ≤6.5%: Insulin Glargine/Lixisenatide FRC vs Lixisenatide.|"HbA1c ≤6.5%: Insulin Glargine/Lixisenatide FRC vs Lixisenatide.~Analysis was performed using Cochran-Mantel-Haenszel method stratified on randomization strata of Week -1 HbA1c (\<8.0%, ≥8.0%) and randomization strata of second OAD use at screening. This analysis was out of testing order."||42.95|29.81|<0.0001
72442387|NCT04714320|144397613|SUPERIORITY||||||=|0.502||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 90 mmHg at Day 169||||=0.502
72442388|NCT04714320|144397613|SUPERIORITY||||||=|0.653||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg and DBP ≤ 90 mmHg at Day 8||||=0.653
72442389|NCT04714320|144397613|SUPERIORITY||||||=|0.816||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg and DBP ≤ 90 mmHg at Day 8||||=0.816
72442390|NCT04714320|144397613|SUPERIORITY||||||=|0.184||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg and DBP ≤ 90 mmHg at Day 15||||=0.184
72442391|NCT04714320|144397613|SUPERIORITY||||||=|0.765||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg and DBP ≤ 90 mmHg at Day 15||||=0.765
72442392|NCT04714320|144397613|SUPERIORITY||||||=|0.009||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg and DBP ≤ 90 mmHg at Day 22||||=0.009
72442393|NCT04714320|144397613|SUPERIORITY||||||=|0.578||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg and DBP ≤ 90 mmHg at Day 22||||=0.578
72442394|NCT04714320|144397613|SUPERIORITY||||||=|0.725||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg and DBP ≤ 90 mmHg at Day 29||||=0.725
72442395|NCT04714320|144397613|SUPERIORITY||||||=|0.287||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg and DBP ≤ 90 mmHg at Day 29||||=0.287
72442396|NCT04714320|144397613|SUPERIORITY||||||=|0.705||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg and DBP ≤ 90 mmHg at Day 36||||=0.705
72442397|NCT04714320|144397613|SUPERIORITY||||||=|0.975||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg and DBP ≤ 90 mmHg at Day 36||||=0.975
72442398|NCT04714320|144397613|SUPERIORITY||||||=|0.118||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg and DBP ≤ 90 mmHg at Day 43||||=0.118
72442399|NCT04714320|144397613|SUPERIORITY||||||=|0.959||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg and DBP ≤ 90 mmHg at Day 43||||=0.959
72442400|NCT04714320|144397613|SUPERIORITY||||||=|0.413||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg and DBP ≤ 90 mmHg at Day 50||||=0.413
72504766|NCT03114969|144540504|SUPERIORITY||Odds Ratio (OR)|1.0||||1|TWO_SIDED|95.0|0.438|2.283||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator.|||2.283|0.438|1.000
72442401|NCT04714320|144397613|SUPERIORITY||||||=|0.043||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg and DBP ≤ 90 mmHg at Day 50||||=0.043
72442402|NCT04714320|144397613|SUPERIORITY||||||=|0.849||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg and DBP ≤ 90 mmHg at Day 57||||=0.849
72442403|NCT04714320|144397613|SUPERIORITY||||||=|0.662||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg and DBP ≤ 90 mmHg at Day 57||||=0.662
72388370|NCT03948581|144284468|EQUIVALENCE|Geometric least-squares means (LSMs) were calculated by exponentiating the LSMs derived from analysis of variance (ANCOVA) with group, treatment, and injection site as fixed effects and weight as a continuous covariate. Confidence intervals (CIs) were calculated using treatment standard errors from the ANCOVA model and t-statistic for error degrees of freedom.|Ratio of Geometric LSMs|0.9807|||||TWO_SIDED|90.0|0.9011|1.0675||||||||1.0675|0.9011|
72388371|NCT03948581|144284469|EQUIVALENCE|Geometric LSMs were calculated by exponentiating the LSMs derived from ANCOVA with group, treatment, and injection site as fixed effects and weight as a continuous covariate. CIs were calculated using treatment standard errors from the ANCOVA model and t-statistic for error degrees of freedom.|Ratio of Geometric LSMs|0.9981|||||TWO_SIDED|90.0|0.9223|1.0801||||||||1.0801|0.9223|
72388372|NCT03948581|144284470|EQUIVALENCE|Geometric LSMs were calculated by exponentiating the LSMs derived from ANCOVA with group, treatment, and injection site as fixed effects and weight as a continuous covariate. CIs were calculated using treatment standard errors from the ANCOVA model and t-statistic for error degrees of freedom.|Ratio of Geometric LSMs|1.0038|||||TWO_SIDED|90.0|0.9401|1.0719||||||||1.0719|0.9401|
72388373|NCT03068455|144284471|SUPERIORITY||Hazard Ratio (HR)|0.9|||||TWO_SIDED|95.0|0.78|1.04|||||Stratified Cox proportional hazard model. Hazard Ratio is Nivolumab + Ipilimumab over Nivolumab|||1.04|0.78|
72388374|NCT03068455|144284472|SUPERIORITY||Hazard Ratio (HR)|0.92|||||TWO_SIDED|95.0|0.75|1.14|||||Stratified Cox proportional hazard model. Hazard Ratio is Nivolumab + Ipilimumab over Nivolumab|||1.14|0.75|
72388375|NCT03068455|144284473|SUPERIORITY||Hazard Ratio (HR)|1.03|||||TWO_SIDED|95.0|0.8|1.32|||||Stratified Cox proportional hazard model. Hazard Ratio is Nivolumab + Ipilimumab over Nivolumab.|||1.32|0.80|
72388376|NCT03068455|144284474|SUPERIORITY||Hazard Ratio (HR)|1.22|||||TWO_SIDED|95.0|0.85|1.73|||||Stratified Cox proportional hazard model. Hazard Ratio is Nivolumab + Ipilimumab over Nivolumab.|||1.73|0.85|
72388377|NCT03068455|144284475|SUPERIORITY|\< 1% Tumor PD-L1 Expression|Hazard Ratio (HR)|0.91|||||TWO_SIDED|95.0|0.73|1.14|||||Unstratisfied HR, Nivolumab over Ipilimumab|||1.14|0.73|
72388378|NCT03068455|144284475|SUPERIORITY|\>= 1% Tumor PD-L1 Expression|Hazard Ratio (HR)|0.95|||||TWO_SIDED|95.0|0.76|1.18|||||Unstratisfied HR, Nivolumab over ipilimumab|||1.18|0.76|
72388379|NCT03068455|144284475|SUPERIORITY|\>= 5% Tumor PD-L1 Expression|Hazard Ratio (HR)|0.98|||||TWO_SIDED|95.0|0.71|1.34|||||Unstratisfied HR, Nivolumab over ipilimumab|||1.34|0.71|
72388380|NCT03068455|144284475|SUPERIORITY|\< 5% Tumor PD-L1 Expression|Hazard Ratio (HR)|0.92|||||TWO_SIDED|95.0|0.77|1.1|||||Unstratisfied HR, Nivolumab over ipilimumab|||1.10|0.77|
72619083|NCT01750281|144768922|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|A hazard ratio \<1 favours selumetinib in combination with docetaxel|Hazard Ratio (HR)|0.92||||0.69|TWO_SIDED|90.0|0.65|1.31|||Cox Proportional Hazards|||||1.31|0.65|0.690
72619084|NCT01750281|144768923|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|A hazard ratio \<1 favours selumetinib in combination with docetaxel|Hazard Ratio (HR)|1.43||||0.126|TWO_SIDED|90.0|0.97|2.13|||Cox Proportional Hazards|||||2.13|0.97|0.126
72388381|NCT03068455|144284475|SUPERIORITY|Non-quantifiable Tumor PD-L1 Expression|Hazard Ratio (HR)|0.76|||||TWO_SIDED|95.0|0.38|1.51|||||Unstratisfied HR, Nivolumab over ipilimumab|||1.51|0.38|
72388382|NCT04472429|144284502|SUPERIORITY||Hazard Ratio (HR)|0.63||||0.0006|TWO_SIDED|95.0|0.47|0.84||tested at the 1-sided 2.5% level|stratified log-rank test||A stratified Cox regression with Efron's method for tie handling was used to estimate the hazard ratio.|||0.84|0.47|0.0006
72388383|NCT01172522|144284515|SUPERIORITY_OR_OTHER||Other|0.0|||=|1|TWO_SIDED||||||Chi-squared||P values above 0.05 is considered statistically insignificant in this study.|||||=1
72388384|NCT00578383|144284565|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.11|STANDARD_ERROR_OF_MEAN|1.17||0.009|TWO_SIDED|95.0|0.5|5.8||We used type HC3 robust standard errors (SEs)in place of OLS regression SEs to guard against biased estimation of SEs due to heteroscedasticity. This is an uncorrected p-value with a required threshold of 0.025 for significance (correction factor 2).|Regression, Linear|Bonferroni multiple testing corrections were applied separately to results for our primary and secondary outcomes.||Active LFMS treatment would reduce depression immediately after treatment in subjects with bipolar depression and those with major depressive disorder as assessed by the 17-item Hamilton Depression Rating Scale.||5.8|0.5|0.009
72388385|NCT00578383|144284566|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.06|STANDARD_ERROR_OF_MEAN|0.38||0.006|TWO_SIDED|95.0|0.2|1.9||We used type HC3 robust standard errors (SEs)in place of OLS regression SEs to guard against biased estimation of SEs due to heteroscedasticity. This is an uncorrected p-value with a required threshold of 0.025 for significance (correction factor 2)|Regression, Linear|Bonferroni multiple testing corrections were applied separately to results for our primary and secondary outcomes.||Active LFMS treatment would reduce depression immediately after treatment in subjects with bipolar depression and those with major depressive disorder as assessed by a visual analog scale.||1.9|0.2|0.006
72388386|NCT00578383|144284567|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.1|STANDARD_ERROR_OF_MEAN|1.24||0.001|TWO_SIDED|95.0|1.3|6.9||we used type HC3 robust standard errors (SEs)in place of OLS regression SEs to guard against biased estimation of SEs due to heteroscedasticity. This is an uncorrected p-value with a required threshold of 0.025 for significance (correction factor 2).|Regression, Linear|Bonferroni multiple testing corrections were applied separately to results for our primary and secondary outcomes.||Active LFMS treatment would reduce depression immediately after treatment in subjects with bipolar depression and those with major depressive disorder as assessed by the PANAS (POSITIVE SCALE).||6.9|1.3|0.001
72388387|NCT00578383|144284568|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.0|STANDARD_ERROR_OF_MEAN|1.39||0.15|TWO_SIDED|95.0|-1.1|5.1||we used type HC3 robust standard errors (SEs)in place of OLS regression SEs to guard against biased estimation of SEs due to heteroscedasticity. This is an uncorrected p-value with a required threshold of 0.025 for significance (correction factor 2).|Regression, Linear|Bonferroni multiple testing corrections were applied separately to results for our primary and secondary outcomes.||Active LFMS treatment would reduce depression immediately after treatment in subjects with bipolar depression and those with major depressive disorder as assessed by the PANAS (negative scale)||5.1|-1.1|0.15
72496442|NCT02058147|144522651|SUPERIORITY_OR_OTHER||Difference in percentage|14.31|||<|0.0001|TWO_SIDED|95.0|8.37|20.25||Threshold for significance ≤ 0.05.|Cochran-Mantel-Haenszel||HbA1c \<7.0%: Insulin Glargine/Lixisenatide FRC vs Insulin glargine.|"HbA1c \<7.0%: Insulin Glargine/Lixisenatide FRC vs Insulin glargine.~Analysis was performed using Cochran-Mantel-Haenszel method stratified on randomization strata of Week -1 HbA1c (\<8.0%, ≥8.0%) and randomization strata of second OAD use at screening. This analysis was out of testing order."||20.25|8.37|<0.0001
72496443|NCT02058147|144522651|SUPERIORITY_OR_OTHER||Difference in percentage|16.35|||<|0.0001|TWO_SIDED|95.0|10.13|22.58||Threshold for significance ≤ 0.05.|Cochran-Mantel-Haenszel||HbA1c ≤6.5%: Insulin Glargine/Lixisenatide FRC vs Insulin glargine.|"HbA1c ≤6.5%: Insulin Glargine/Lixisenatide FRC vs Insulin glargine.~Analysis was performed using Cochran-Mantel-Haenszel method stratified on randomization strata of Week -1 HbA1c (\<8.0%, ≥8.0%) and randomization strata of second OAD use at screening. This analysis was out of testing order."||22.58|10.13|<0.0001
72496444|NCT02058147|144522652|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.13|STANDARD_ERROR_OF_MEAN|0.185|<|0.0001|TWO_SIDED|95.0|-2.498|-1.77||Threshold for significance ≤0.05. The hierarchical testing continued only when primary hypotheses (superiority: FRC to lixisenatide; non-inferiority: FRC to insulin glargine for HbA1c) was statistically significant.|ANCOVA||Insulin Glargine/Lixisenatide FRC vs Insulin glargine.|Analysis was performed using analysis of covariance (ANCOVA) model with treatment groups, randomization strata of Week -1 HbA1c (\<8.0,≥8.0%), randomization strata of second OAD use at screening \& country as fixed effects \& baseline plasma glucose excursion value as a covariate. Hierarchical testing procedure was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially per pre-specified order.||-1.77|-2.498|<0.0001
72442404|NCT04714320|144397613|SUPERIORITY||||||=|0.047||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg and DBP ≤ 90 mmHg at Day 64||||=0.047
72442405|NCT04714320|144397613|SUPERIORITY||||||=|0.95||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg and DBP ≤ 90 mmHg at Day 64||||=0.950
72442406|NCT04714320|144397613|SUPERIORITY||||||=|0.656||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg and DBP ≤ 90 mmHg at Day 71||||=0.656
72442407|NCT04714320|144397613|SUPERIORITY||||||=|0.922||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg and DBP ≤ 90 mmHg at Day 71||||=0.922
72442408|NCT04714320|144397613|SUPERIORITY||||||=|0.143||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg and DBP ≤ 90 mmHg at Day 78||||=0.143
72442409|NCT04714320|144397613|SUPERIORITY||||||=|0.452||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg and DBP ≤ 90 mmHg at Day 78||||=0.452
72442410|NCT04714320|144397613|SUPERIORITY||||||=|0.231||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg and DBP ≤ 90 mmHg at Day 85||||=0.231
72442411|NCT04714320|144397613|SUPERIORITY||||||=|0.405||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg and DBP ≤ 90 mmHg at Day 85||||=0.405
72496445|NCT02058147|144522653|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.4|STANDARD_ERROR_OF_MEAN|0.25|<|0.0001|TWO_SIDED|95.0|-1.891|-0.91||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Insulin Glargine/Lixisenatide FRC vs Insulin glargine|Testing according to the hierarchical testing procedure (continued only if previous endpoints were statistically significant). Analysis was performed using MMRM model with treatment groups, randomization strata of Week -1 HbA1c (\<8.0, ≥8.0%), randomization strata of second OAD use at screening, visits, treatment-by-visit interaction, and country as fixed effects and baseline body weight value-by-visit interaction as a covariate.||-0.91|-1.891|<0.0001
72496446|NCT02058147|144522654|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.96|STANDARD_ERROR_OF_MEAN|0.144|<|0.0001|TWO_SIDED|95.0|-2.246|-1.682||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Insulin Glargine/Lixisenatide FRC vs Lixisenatide|Testing according to the hierarchical testing procedure (continued only if previous endpoints were statistically significant). Analysis was performed using MMRM model with treatment groups, randomization strata of Week -1 HbA1c (\<8.0, ≥8.0%), randomization strata of second OAD use at screening, visits, treatment-by-visit interaction, and country as fixed effects and baseline FPG value-by-visit interaction as a covariate.||-1.682|-2.246|<0.0001
72619085|NCT01750281|144768923|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|A hazard ratio \<1 favours selumetinib in combination with docetaxel|Hazard Ratio (HR)|1.18||||0.485|TWO_SIDED|90.0|0.8|1.78|||Cox Proportional Hazards|||||1.78|0.80|0.485
72442412|NCT04714320|144397613|SUPERIORITY||||||=|0.718||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg and DBP ≤ 90 mmHg at Day 92||||=0.718
72442413|NCT04714320|144397613|SUPERIORITY||||||=|0.053||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg and DBP ≤ 90 mmHg at Day 92||||=0.053
72442414|NCT04714320|144397613|SUPERIORITY||||||=|0.893||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg and DBP ≤ 90 mmHg at Day 106||||=0.893
72442415|NCT04714320|144397613|SUPERIORITY||||||=|0.662||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg and DBP ≤ 90 mmHg at Day 106||||=0.662
72442416|NCT04714320|144397613|SUPERIORITY||||||=|0.688||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg and DBP ≤ 90 mmHg at Day 120||||=0.688
72442417|NCT04714320|144397613|SUPERIORITY||||||=|0.611||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg and DBP ≤ 90 mmHg at Day 120||||=0.611
72442418|NCT04714320|144397613|SUPERIORITY||||||=|0.907||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg and DBP ≤ 90 mmHg at Day 148||||=0.907
72442419|NCT04714320|144397613|SUPERIORITY||||||=|0.699||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg and DBP ≤ 90 mmHg at Day 148||||=0.699
72442420|NCT04714320|144397613|SUPERIORITY||||||=|0.802||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg and DBP ≤ 90 mmHg at Day 169||||=0.802
72442421|NCT04714320|144397613|SUPERIORITY||||||=|0.206||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg and DBP ≤ 90 mmHg at Day 169||||=0.206
72442422|NCT04714320|144397614|SUPERIORITY||||||=|0.28||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg at Day 8||||=0.280
72442423|NCT04714320|144397614|SUPERIORITY||||||=|0.648||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg at Day 8||||=0.648
72442424|NCT04714320|144397614|SUPERIORITY||||||=|0.416||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg at Day 15||||=0.416
72496447|NCT02058147|144522655|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.4|STANDARD_ERROR_OF_MEAN|0.124|<|0.0001|TWO_SIDED|95.0|-1.645|-1.158||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Insulin Glargine/Lixisenatide FRC vs Lixisenatide|Testing according to the hierarchical testing procedure (continued only if previous endpoints were statistically significant). Analysis was performed using MMRM model with treatment groups, randomization strata of Week -1 HbA1c (\<8.0, ≥8.0%), randomization strata of second OAD use at screening, visits, treatment-by-visit interaction, and country as fixed effects and baseline 7-point SMPG value-by-visit interaction as a covariate.||-1.158|-1.645|<0.0001
72442425|NCT04714320|144397614|SUPERIORITY||||||=|0.9||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg at Day 15||||=0.900
72504767|NCT03114969|144540505|SUPERIORITY||Odds Ratio (OR)|1.935||||0.067|TWO_SIDED|95.0|0.955|3.921||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator.|||3.921|0.955|0.067
72619086|NCT03156621|144768933|SUPERIORITY||Least squares (LS) mean difference|-35.6|STANDARD_ERROR_OF_MEAN|7.8|<|0.0001|TWO_SIDED|95.0|-51.2|-19.9||P-value taken from MMRM (mixed-effect model with repeated measures) analysis|MMRM||p-value vs Placebo|||-19.9|-51.2|<0.0001
72442426|NCT04714320|144397614|SUPERIORITY||||||=|0.627||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg at Day 22||||=0.627
72442427|NCT04714320|144397614|SUPERIORITY||||||=|0.921||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg at Day 22||||=0.921
72496448|NCT02058147|144522655|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.69|STANDARD_ERROR_OF_MEAN|0.101|<|0.0001|TWO_SIDED|95.0|-0.892|-0.495||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Insulin Glargine/Lixisenatide FRC vs Insulin Glargine|Testing according to the hierarchical testing procedure (continued only if previous endpoints were statistically significant). Analysis was performed using MMRM model with treatment groups, randomization strata of Week -1 HbA1c (\<8.0, ≥8.0%), randomization strata of second OAD use at screening, visits, treatment-by-visit interaction, and country as fixed effects and baseline 7-point SMPG value-by-visit interaction, as a covariate.||-0.495|-0.892|<0.0001
72496449|NCT02058147|144522656|SUPERIORITY_OR_OTHER||Difference in percentage|18.08|||<|0.0001|TWO_SIDED|95.0|12.15|24.01||Threshold for significance ≤ 0.05.|Cochran-Mantel-Haenszel||Insulin Glargine/Lixisenatide FRC vs Insulin glargine|Testing according to the hierarchical testing procedure (continued only if previous endpoints were statistically significant). Analysis was performed using Cochran-Mantel-Haenszel method stratified on randomization strata of Week -1 HbA1c (\<8%, ≥8%) and randomization strata of second OAD use at screening.||24.01|12.15|<0.0001
72442428|NCT04714320|144397614|SUPERIORITY||||||=|0.464||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg at Day 29||||=0.464
72442429|NCT04714320|144397614|SUPERIORITY||||||=|0.458||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg at Day 29||||=0.458
72442430|NCT04714320|144397614|SUPERIORITY||||||=|0.779||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg at Day 36||||=0.779
72442431|NCT04714320|144397614|SUPERIORITY||||||=|0.629||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg at Day 36||||=0.629
72442432|NCT04714320|144397614|SUPERIORITY||||||=|0.242||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg at Day 43||||=0.242
72442433|NCT04714320|144397614|SUPERIORITY||||||=|0.29||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg at Day 43||||=0.290
72442434|NCT04714320|144397614|SUPERIORITY||||||=|0.349||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg at Day 50||||=0.349
72442435|NCT04714320|144397614|SUPERIORITY||||||=|0.532||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg at Day 50||||=0.532
72442436|NCT04714320|144397614|SUPERIORITY||||||=|0.205||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg at Day 57||||=0.205
72442437|NCT04714320|144397614|SUPERIORITY||||||=|0.368||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg at Day 57||||=0.368
72442438|NCT04714320|144397614|SUPERIORITY||||||=|0.084||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg at Day 64||||=0.084
72619087|NCT03156621|144768934|SUPERIORITY||Least squares (LS) mean difference|-29.8|STANDARD_ERROR_OF_MEAN|6.3|<|0.0001|TWO_SIDED|95.0|-42.3|-17.3||p-value taken from MMRM (mixed-effect model with repeated measures) analysis|MMRM|||||-17.3|-42.3|< 0.0001
72442439|NCT04714320|144397614|SUPERIORITY||||||=|0.179||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg at Day 64||||=0.179
72619088|NCT03156621|144768935|SUPERIORITY||Least squares (LS) mean difference|-32.9|STANDARD_ERROR_OF_MEAN|7.4|<|0.0001|TWO_SIDED|95.0|-47.6|-18.2||P-value taken from MMRM (mixed-effect model with repeated measures) analysis|MMRM|||||-18.2|-47.6|< 0.0001
72619089|NCT03156621|144768936|SUPERIORITY||Least squares (LS) mean difference|-26.5|STANDARD_DEVIATION|6.2|<|0.0001|TWO_SIDED|95.0|-38.9|-14.0||P-value taken from MMRM (mixed-effect model with repeated measures) analysis.|MMRM|||||-14.0|-38.9|< 0.0001
72442440|NCT04714320|144397614|SUPERIORITY||||||=|0.584||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg at Day 71||||=0.584
72442441|NCT04714320|144397614|SUPERIORITY||||||=|0.762||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg at Day 71||||=0.762
72496450|NCT02058147|144522657|SUPERIORITY_OR_OTHER||Difference in percentage|12.98|||<|0.0001|TWO_SIDED|95.0|7.5|18.45||Threshold for significance ≤ 0.05.|Cochran-Mantel-Haenszel||Insulin Glargine/Lixisenatide FRC vs Insulin Glargine|Testing according to the hierarchical testing procedure (continued only if previous endpoints were statistically significant). Analysis was performed using Cochran-Mantel-Haenszel method stratified on randomization strata of Week -1 HbA1c (\<8.0%, ≥8.0%) and randomization strata of second OAD use at screening.||18.45|7.5|< 0.0001
72496451|NCT02058147|144522658|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.69|STANDARD_ERROR_OF_MEAN|0.99||0.4857|TWO_SIDED|95.0|-2.632|1.252||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Insulin Glargine/Lixisenatide FRC vs Insulin Glargine|Testing according to the hierarchical testing procedure (continued only if previous endpoints were statistically significant). Analysis was performed using MMRM model with treatment groups, randomization strata of Week -1 HbA1c (\<8.0, ≥8.0%), randomization strata of second OAD use at screening, visits, treatment-by-visit interaction, and country as fixed effects.||1.252|-2.632|0.4857
72496452|NCT00820573|144522669|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||"A general unstructured variance-covariance matrix (ANOVA) was applied for measurements at different periods. Between-group comparisons after 6 wks of treatment were assessed using the ANOVA model at alpha=0.05 (two-sided).~16 subjects provide \~90% power to detect difference in EGP of 0.28 mg/kg.min (95% CI = 0.17 mg/kg.min)."||||<0.05
72496453|NCT00820573|144522670|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||ANOVA|||multivariate analysis was performed to compare results amongst all four groups||||<0.05
72496454|NCT00820573|144522671|SUPERIORITY_OR_OTHER|||||||0.05|||||||ANOVA|||ANOVA||||0.05
72496455|NCT00820573|144522672|SUPERIORITY_OR_OTHER|||||||0.05|||||||ANOVA|||||||0.05
72442442|NCT04714320|144397614|SUPERIORITY||||||=|0.675||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg at Day 78||||=0.675
72442443|NCT04714320|144397614|SUPERIORITY||||||=|0.166||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg at Day 78||||=0.166
72442444|NCT04714320|144397614|SUPERIORITY||||||=|0.09||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg at Day 85||||=0.090
72442445|NCT04714320|144397614|SUPERIORITY||||||=|0.488||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg at Day 85||||=0.488
72496456|NCT03604445|144522673|OTHER||Probability of DLT rate in [0.16, 0.33)|0.0|||||||||||||Posterior probabilities of the DLT rate lying in the intervals \[0.16, 0.33) (target dosing), and \[0.33,1\] (overdosing) are reported.|Bayesian logistic regression model (BLRM) with overdose control was used to determine the maximum tolerated dose (MTD), defined as highest dose with less than 25% risk of the true DLT rate being equal to or above 33%.|Probability of DLT rate in \[0.33, 1\] = 0|||
72496457|NCT03604445|144522673|OTHER||Probability of DLT rate in [0.16, 0.33)|0.0|||||||||||||Posterior probabilities of the DLT rate lying in the intervals \[0.16, 0.33) (target dosing), and \[0.33,1\] (overdosing) are reported.|Bayesian logistic regression model (BLRM) with overdose control was used to determine the maximum tolerated dose (MTD), defined as highest dose with less than 25% risk of the true DLT rate being equal to or above 33%.|Probability of DLT rate in \[0.33, 1\] = 0|||
72496458|NCT03604445|144522673|OTHER||Probability of DLT rate in [0.16, 0.33)|0.0|||||||||||||Posterior probabilities of the DLT rate lying in the intervals \[0.16, 0.33) (target dosing), and \[0.33,1\] (overdosing) are reported.|Bayesian logistic regression model (BLRM) with overdose control was used to determine the maximum tolerated dose (MTD), defined as highest dose with less than 25% risk of the true DLT rate being equal to or above 33%.|Probability of DLT rate in \[0.33, 1\] = 0|||
72496459|NCT03604445|144522673|OTHER||Probability of DLT rate in [0.16, 0.33)|0.0|||||||||||||Posterior probabilities of the DLT rate lying in the intervals \[0.16, 0.33) (target dosing), and \[0.33,1\] (overdosing) are reported.|Bayesian logistic regression model (BLRM) with overdose control was used to determine the maximum tolerated dose (MTD), defined as highest dose with less than 25% risk of the true DLT rate being equal to or above 33%.|Probability of DLT rate in \[0.33, 1\] = 0|||
72496460|NCT03604445|144522673|OTHER||Probability of DLT rate in [0.16, 0.33)|0.0|||||||||||||Posterior probabilities of the DLT rate lying in the intervals \[0.16, 0.33) (target dosing), and \[0.33,1\] (overdosing) are reported.|Bayesian logistic regression model (BLRM) with overdose control was used to determine the maximum tolerated dose (MTD), defined as highest dose with less than 25% risk of the true DLT rate being equal to or above 33%.|Probability of DLT rate in \[0.33, 1\] = 0|||
72496461|NCT03604445|144522673|OTHER||Probability of DLT rate in [0.16, 0.33)|0.003|||||||||||||Posterior probabilities of the DLT rate lying in the intervals \[0.16, 0.33) (target dosing), and \[0.33,1\] (overdosing) are reported.|Bayesian logistic regression model (BLRM) with overdose control was used to determine the maximum tolerated dose (MTD), defined as highest dose with less than 25% risk of the true DLT rate being equal to or above 33%.|Probability of DLT rate in \[0.33, 1\] = 0|||
72496462|NCT03604445|144522673|OTHER||Probability of DLT rate in [0.16, 0.33)|0.035|||||||||||||Posterior probabilities of the DLT rate lying in the intervals \[0.16, 0.33) (target dosing), and \[0.33,1\] (overdosing) are reported.|Bayesian logistic regression model (BLRM) with overdose control was used to determine the maximum tolerated dose (MTD), defined as highest dose with less than 25% risk of the true DLT rate being equal to or above 33%.|Probability of DLT rate in \[0.33, 1\] = 0.001|||
72619090|NCT03156621|144768937|SUPERIORITY||Odds Ratio, log|12.2|||=|0.0004|TWO_SIDED|95.0|3.1|48.8|||Regression, Logistic|||||48.8|3.1|= 0.0004
72496463|NCT03604445|144522673|OTHER||Probability of DLT rate in [0.16, 0.33)|0.176|||||||||||||Posterior probabilities of the DLT rate lying in the intervals \[0.16, 0.33) (target dosing), and \[0.33,1\] (overdosing) are reported.|Bayesian logistic regression model (BLRM) with overdose control was used to determine the maximum tolerated dose (MTD), defined as highest dose with less than 25% risk of the true DLT rate being equal to or above 33%.|Probability of DLT rate in \[0.33, 1\] = 0.018|||
72442446|NCT04714320|144397614|SUPERIORITY||||||=|0.218||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg at Day 92||||=0.218
72442447|NCT04714320|144397614|SUPERIORITY||||||=|0.232||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg at Day 92||||=0.232
72442448|NCT04714320|144397614|SUPERIORITY||||||=|0.421||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg at Day 106||||=0.421
72442449|NCT04714320|144397614|SUPERIORITY||||||=|0.815||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg at Day 106||||=0.815
72442450|NCT04714320|144397614|SUPERIORITY||||||=|0.711||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg at Day 120||||=0.711
72442451|NCT04714320|144397614|SUPERIORITY||||||=|0.514||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg at Day 120||||=0.514
72442452|NCT04714320|144397614|SUPERIORITY||||||=|0.479||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg at Day 148||||=0.479
72442453|NCT04714320|144397614|SUPERIORITY||||||=|0.292||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg at Day 148||||=0.292
72442454|NCT04714320|144397614|SUPERIORITY||||||=|0.528||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg at Day 169||||=0.528
72442455|NCT04714320|144397614|SUPERIORITY||||||=|0.946||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg at Day 169||||=0.946
72496464|NCT03604445|144522673|OTHER||Probability of DLT rate in [0.16, 0.33)|0.129|||||||||||||Posterior probabilities of the DLT rate lying in the intervals \[0.16, 0.33) (target dosing), and \[0.33,1\] (overdosing) are reported.|Bayesian logistic regression model (BLRM) with overdose control was used to determine the maximum tolerated dose (MTD), defined as highest dose with less than 25% risk of the true DLT rate being equal to or above 33%.|Probability of DLT rate in \[0.33, 1\] = 0.83|||
72496465|NCT01360645|144522680|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.12||||0.0001|TWO_SIDED|95.0|-4.7|-1.54|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||The primary analysis was performed on the Efficacy Sample by fitting a Mixed Model Repeated Measures (MMRM) analysis with an unstructured variance covariance structure in which the change from the end of Phase A (Week 8) in MADRS Total Score (at Weeks 9 to 14) was the dependent variable. The model included fixed class effect terms for treatment, trial site, visit week, and an interaction term of treatment by visit week.||-1.54|-4.70|0.0001
72496466|NCT01360645|144522681|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.21||||0.0002|TWO_SIDED|95.0|-4.87|-1.54|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||||-1.54|-4.87|0.0002
72496467|NCT01360645|144522682|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.45||||0.0372|TWO_SIDED|95.0|-0.86|-0.03|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||||-0.03|-0.86|0.0372
72559721|NCT01541215|144649515|SUPERIORITY|"Stepwise hierarchical testing procedure was applied for confirmatory endpoints:~Step 1: Primary analysis: change from baseline to week 26 in HbA1c~Superiority of liraglutide over placebo was to be concluded if the 95% confidence interval for the treatment difference for change from baseline in HbA1c (%) after 26 weeks of randomised treatment was entirely below 0%, implying that the two sided p-value was less than 5%."|Treatment difference|-1.058|STANDARD_ERROR_OF_MEAN|0.304|<|0.001|TWO_SIDED|95.0|-1.653|-0.464|||Pattern Mixture Model|||Analysis using a pattern mixture model of observed data with missing observations imputed from the placebo arm based on multiple (x10.000) imputations. The data for week 26 were then analysed with an ANCOVA model containing treatment, sex and age group as fixed effects and baseline value as covariate. The estimated treatment differences and confidence intervals were combined using Rubins formula.||-0.464|-1.653|<0.001
72442456|NCT04714320|144397614|SUPERIORITY||||||=|0.552||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 80 mmHg at Day 8||||=0.552
72442457|NCT04714320|144397614|SUPERIORITY||||||=|0.598||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 80 mmHg at Day 8||||=0.598
72442458|NCT04714320|144397614|SUPERIORITY||||||=|0.184||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 80 mmHg at Day 15||||=0.184
72442459|NCT04714320|144397614|SUPERIORITY||||||=|0.614||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 80 mmHg at Day 15||||=0.614
72442460|NCT04714320|144397614|SUPERIORITY||||||=|0.933||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 80 mmHg at Day 22||||=0.933
72442461|NCT04714320|144397614|SUPERIORITY||||||=|0.803||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 80 mmHg at Day 22||||=0.803
72442462|NCT04714320|144397614|SUPERIORITY||||||=|0.686||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 80 mmHg at Day 29||||=0.686
72442463|NCT04714320|144397614|SUPERIORITY||||||=|0.752||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 80 mmHg at Day 29||||=0.752
72442464|NCT04714320|144397614|SUPERIORITY||||||=|0.106||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 80 mmHg at Day 36||||=0.106
72442465|NCT04714320|144397614|SUPERIORITY||||||=|0.779||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 80 mmHg at Day 36||||=0.779
72442466|NCT04714320|144397614|SUPERIORITY||||||=|0.323||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 80 mmHg at Day 43||||=0.323
72442467|NCT04714320|144397614|SUPERIORITY||||||=|0.991||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 80 mmHg at Day 43||||=0.991
72442468|NCT04714320|144397614|SUPERIORITY||||||=|0.973||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 80 mmHg at Day 50||||=0.973
72442469|NCT04714320|144397614|SUPERIORITY||||||=|0.23||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 80 mmHg at Day 50||||=0.230
72442470|NCT04714320|144397614|SUPERIORITY||||||=|0.792||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 80 mmHg at Day 57||||=0.792
72442471|NCT04714320|144397614|SUPERIORITY||||||=|0.744||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 80 mmHg at Day 57||||=0.744
72442472|NCT04714320|144397614|SUPERIORITY|Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|||||=|0.925|||||||Regression, Logistic|||Seated Automated Office DBP ≤ 80 mmHg at Day 64||||=0.925
72442473|NCT04714320|144397614|SUPERIORITY||||||=|0.991||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 80 mmHg at Day 64||||=0.991
72496468|NCT01360645|144522683|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.46||||0.0349|TWO_SIDED|95.0|-0.88|-0.03|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||||-0.03|-0.88|0.0349
72442474|NCT04714320|144397614|SUPERIORITY|Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|||||=|0.53|||||||Regression, Logistic|||Seated Automated Office DBP ≤ 80 mmHg at Day 71||||=0.530
72442475|NCT04714320|144397614|SUPERIORITY||||||=|0.849||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 80 mmHg at Day 71||||=0.849
72619091|NCT03156621|144768938|SUPERIORITY||Odds Ratio, log|36.5|||=|0.001|TWO_SIDED|95.0|4.3|308.9|||Regression, Logistic|||||308.9|4.3|= 0.0010
72442476|NCT04714320|144397614|SUPERIORITY||||||=|0.953||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 80 mmHg at Day 78||||=0.953
72442477|NCT04714320|144397614|SUPERIORITY||||||=|0.884||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 80 mmHg at Day 78||||=0.884
72442478|NCT04714320|144397614|SUPERIORITY||||||=|0.23||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 80 mmHg at Day 85||||=0.230
72619092|NCT03156621|144768939|SUPERIORITY||Mean Difference (Final Values)|-28.4|STANDARD_DEVIATION|6.7|<|0.0001|TWO_SIDED|95.0|-41.5|-15.2|||Regression model|||||-15.2|-41.5|< 0.0001
72388388|NCT00578383|144284569|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.5|STANDARD_ERROR_OF_MEAN|1.47||0.09|TWO_SIDED|95.0|-1.2|6.2||We used type HC3 robust standard errors (SEs)in place of OLS regression SEs to guard against biased estimation of SEs due to heteroscedasticity. This is an uncorrected p-value with a required threshold of 0.0125 for significance (correction factor 4)|Regression, Linear|Bonferroni multiple testing corrections were applied separately to results for our primary and secondary outcomes.||Active LFMS treatment would reduce depression immediately after treatment in subjects with bipolar depression as assessed by the 17-item Hamilton Depression Rating Scale.||6.2|-1.2|0.09
72388389|NCT00578383|144284570|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.2|STANDARD_ERROR_OF_MEAN|2.11||0.19|TWO_SIDED|95.0|-3.3|9.6||We used type HC3 robust standard errors (SEs)in place of OLS regression SEs to guard against biased estimation of SEs due to heteroscedasticity. This is an uncorrected p-value with a required threshold of 0.0125 for significance (correction factor 4)|Regression, Linear|Bonferroni multiple testing corrections were applied separately to results for our primary and secondary outcomes.||Active LFMS treatment would reduce depression immediately after treatment in subjects with major depressive disorder as assessed by the 17-item Hamilton Depression Rating Scale.||9.6|-3.3|0.19
72442479|NCT04714320|144397614|SUPERIORITY||||||=|0.589||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 80 mmHg at Day 85||||=0.589
72442480|NCT04714320|144397614|SUPERIORITY||||||=|0.919||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 80 mmHg at Day 92||||=0.919
72442481|NCT04714320|144397614|SUPERIORITY||||||=|0.753||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 80 mmHg at Day 92||||=0.753
72442482|NCT04714320|144397614|SUPERIORITY||||||=|0.747||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 80 mmHg at Day 106||||=0.747
72442483|NCT04714320|144397614|SUPERIORITY||||||=|0.764||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 80 mmHg at Day 106||||=0.764
72442484|NCT04714320|144397614|SUPERIORITY||||||=|0.527||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 80 mmHg at Day 120||||=0.527
72442485|NCT04714320|144397614|SUPERIORITY||||||=|0.639||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 80 mmHg at Day 120||||=0.639
72442486|NCT04714320|144397614|SUPERIORITY||||||=|0.744||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 80 mmHg at Day 148||||=0.744
72442487|NCT04714320|144397614|SUPERIORITY||||||=|0.539||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 80 mmHg at Day 148||||=0.539
72442488|NCT04714320|144397614|SUPERIORITY||||||=|0.417||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 80 mmHg at Day 169||||=0.417
72442489|NCT04714320|144397614|SUPERIORITY||||||=|0.466||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 80 mmHg at Day 169||||=0.466
72619093|NCT03156621|144768940|SUPERIORITY||Odds Ratio (OR)|17.7|||=|0.0017|TWO_SIDED|95.0|3.3||Maximum likelihood estimate does not exist||Exact Conditional Logistic Regression||||||3.3|= 0.0017
72619094|NCT03156621|144768941|SUPERIORITY||Least squares (LS) mean difference|3.6|STANDARD_ERROR_OF_MEAN|3.8|=|0.3541|TWO_SIDED|95.0|-4.1|11.3||P-value taken from MMRM (mixed-effect model with repeated measures) analysis.|MMRM|||||11.3|-4.1|= 0.3541
72559722|NCT01541215|144649516|SUPERIORITY|"Stepwise hierarchical testing procedure was applied for confirmatory endpoints:~Step 2: Change from baseline in FPG after 26 weeks of treatment"|Treatment difference|-1.878|STANDARD_ERROR_OF_MEAN|0.62||0.002|TWO_SIDED|95.0|-3.093|-0.662|||Pattern Mixture Model|||Analysis using a pattern mixture model of observed data with missing observations imputed from the placebo arm based on multiple (x10.000) imputations. The data for weeks 26 were then analysed with an ANCOVA model containing treatment, sex and age group as fixed effects and baseline value as covariate. The estimated treatment differences and confidence intervals were combined using Rubins formula.||-0.662|-3.093|0.002
72559723|NCT01541215|144649517|SUPERIORITY|"Stepwise hierarchical testing procedure was applied for confirmatory endpoints:~Step 3: HbA1c \< 7.0% after 26 weeks of treatment"|Treatment odds ratio|5.353|||<|0.001|TWO_SIDED|95.0|2.105|13.615|||logistic regression model|||Missing data was imputed using pattern mixture model. For each imputed data set the binary response was analysed in a logistic regression model using a logit link with treatment and stratification group (gender\*age group) as fixed factors and baseline HbA1c as covariate.The estimated treatment effects and confidence intervals were combined using Rubin´s formula.||13.615|2.105|<0.001
72619095|NCT03156621|144768942|SUPERIORITY||Mean Difference (Final Values)|-11.3|STANDARD_ERROR_OF_MEAN|7.1|||TWO_SIDED|95.0|-25.2|2.6||||||||2.6|-25.2|
72442490|NCT04714320|144397614|SUPERIORITY||||||=|0.38||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg and DBP ≤ 80 mmHg at Day 8||||=0.380
72442491|NCT04714320|144397614|SUPERIORITY||||||=|0.73||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg and DBP ≤ 80 mmHg at Day 8||||=0.730
72442492|NCT04714320|144397614|SUPERIORITY||||||=|0.595||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg and DBP ≤ 80 mmHg at Day 15||||=0.595
72442493|NCT04714320|144397614|SUPERIORITY||||||=|0.279||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg and DBP ≤ 80 mmHg at Day 15||||=0.279
72442494|NCT04714320|144397614|SUPERIORITY||||||=|0.196||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg and DBP ≤ 80 mmHg at Day 22||||=0.196
72442495|NCT04714320|144397614|SUPERIORITY||||||=|0.728||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg and DBP ≤ 80 mmHg at Day 22||||=0.728
72442496|NCT04714320|144397614|SUPERIORITY||||||=|0.453||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg and DBP ≤ 80 mmHg at Day 29||||=0.453
72442497|NCT04714320|144397614|SUPERIORITY||||||=|0.681||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg and DBP ≤ 80 mmHg at Day 29||||=0.681
72442498|NCT04714320|144397614|SUPERIORITY||||||=|0.863||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg and DBP ≤ 80 mmHg at Day 36||||=0.863
72442499|NCT04714320|144397614|SUPERIORITY||||||=|0.837||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg and DBP ≤ 80 mmHg at Day 36||||=0.837
72442500|NCT04714320|144397614|SUPERIORITY||||||=|0.504||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg and DBP ≤ 80 mmHg at Day 43||||=0.504
72442501|NCT04714320|144397614|SUPERIORITY||||||=|0.531||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg and DBP ≤ 80 mmHg at Day 43||||=0.531
72619096|NCT03156621|144768943|SUPERIORITY||Least squares (LS) mean difference|3.6|STANDARD_DEVIATION|3.6|||TWO_SIDED|95.0|-3.6|10.7||||||||10.7|-3.6|
72619097|NCT03156621|144768944|SUPERIORITY||Least squares (LS) mean difference|-35.6|STANDARD_ERROR_OF_MEAN|7.8|||TWO_SIDED|95.0|-51.2|-19.9||||||||-19.9|-51.2|
72442502|NCT04714320|144397614|SUPERIORITY||||||=|0.6||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg and DBP ≤ 80 mmHg at Day 50||||=0.600
72496469|NCT01360645|144522684|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.29||||0.008|TWO_SIDED|95.0|-2.25|-0.34|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||Statistical analysis for Week 9||-0.34|-2.25|0.0080
72559724|NCT01541215|144649518|SUPERIORITY|"Stepwise hierarchical testing procedure was applied for confirmatory endpoints:~Step 4: Change from baseline in BMI SDS after 26 weeks of treatment"|Treatment difference|-0.047|STANDARD_ERROR_OF_MEAN|0.055||0.392|TWO_SIDED|95.0|-0.153|0.06|||Pattern Mixture Model|||Analysis using a pattern mixture model of observed data with missing observations imputed from the placebo arm based on multiple (x10.000) imputations. The data for weeks 26 were then analysed with an ANCOVA model containing treatment, sex and age group as fixed effects and baseline value as covariate. The estimated treatment differences and confidence intervals were combined using Rubins formula.||0.060|-0.153|0.392
72559725|NCT02906813|144649613|SUPERIORITY_OR_OTHER||Least Square (LS) Mean Ratio|0.631||||0.079|TWO_SIDED|90.0|0.411|0.969|||ANOVA|||Analysis of variance (ANOVA) was performed on natural logarithms of TAK-935 Cmax with fixed factors of sequence, period and regimen, and random factor of participant nested within sequence. Pairwise comparisons was used to assess relative bioavailability (BA) of TAK-935 tablet to solution. Point estimate and 90 percent (%) confidence interval (CI) in original scale were obtained by exponentiation of differences in natural-log scale.||0.969|0.411|0.079
72496470|NCT01360645|144522684|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.72||||0.0045|TWO_SIDED|95.0|-2.91|-0.54|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||Statistical analysis for Week 10||-0.54|-2.91|0.0045
72559726|NCT02906813|144649613|SUPERIORITY_OR_OTHER||LS Mean Ratio|0.403||||0.002|TWO_SIDED|90.0|0.262|0.618|||ANOVA|||ANOVA was performed on natural logarithms of TAK-935 Cmax with fixed factors of sequence, period, and regimen and random factor of participant nested within sequence. Pairwise comparisons was used to assess relative BA of TAK-935 administered after high-fat meal versus fasted. Point estimate and its 90% confidence interval in original scale were obtained by exponentiation of differences in natural-log scale.||0.618|0.262|0.002
72559727|NCT02906813|144649614|SUPERIORITY_OR_OTHER||LS Mean Ratio|0.85||||0.146|TWO_SIDED|90.0|0.706|1.024|||ANOVA|||ANOVA was performed on natural logarithms of TAK-935 AUCt with fixed factors of sequence, period, and regimen and random factor of participant nested within sequence. Pairwise comparisons was used to assess relative BA of TAK-935 tablet to solution. Point estimate and 90% CI in original scale were obtained by exponentiation of differences in natural-log scale.||1.024|0.706|0.146
72619098|NCT03156621|144768945|SUPERIORITY||Least squares (LS) mean difference|-29.8|STANDARD_ERROR_OF_MEAN|6.3|||TWO_SIDED|95.0|-43.3|-17.3||||||||-17.3|-43.3|
72388390|NCT00578383|144284571|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.76|STANDARD_ERROR_OF_MEAN|0.51||0.15|TWO_SIDED|95.0|-0.6|2.1||We used type HC3 robust standard errors (SEs)in place of OLS regression SEs to guard against biased estimation of SEs due to heteroscedasticity. This is an uncorrected p-value with a required threshold of 0.0125 for significance (correction factor 4)|Regression, Linear|Bonferroni multiple testing corrections were applied separately to results for our primary and secondary outcomes.||Active LFMS treatment would reduce depression immediately after treatment in subjects with bipolar depression as assessed by a visual analog scale.||2.1|-0.6|0.15
72388391|NCT00578383|144284572|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.58|STANDARD_ERROR_OF_MEAN|0.67||0.04|TWO_SIDED|95.0|-0.4|3.6||We used type HC3 robust standard errors (SEs)in place of OLS regression SEs to guard against biased estimation of SEs due to heteroscedasticity. This is an uncorrected p-value with a required threshold of 0.0125 for significance (correction factor 4)|Regression, Linear|Bonferroni multiple testing corrections were applied separately to results for our primary and secondary outcomes.||Active LFMS treatment would reduce depression immediately after treatment in subjects with major depressive disorder as assessed by a visual analog scale.||3.6|-0.4|0.04
72388392|NCT00578383|144284573|SUPERIORITY_OR_OTHER||Mean Difference (Net)|5.0|STANDARD_ERROR_OF_MEAN|1.67||0.004|TWO_SIDED|95.0|0.8|9.2||we used type HC3 robust standard errors (SEs)in place of OLS regression SEs to guard against biased estimation of SEs due to heteroscedasticity. This is an uncorrected p-value with a required threshold of 0.0125 for significance (correction factor 4)|Regression, Linear|Bonferroni multiple testing corrections were applied separately to results for our primary and secondary outcomes.||Active LFMS treatment would reduce depression immediately after treatment in subjects with bipolar depression as assessed by the PANAS (positive scale)||9.2|0.8|0.004
72388393|NCT00578383|144284574|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.7|STANDARD_ERROR_OF_MEAN|1.58||0.3|TWO_SIDED|95.0|1.3|5.8||we used type HC3 robust standard errors (SEs)in place of OLS regression SEs to guard against biased estimation of SEs due to heteroscedasticity. This is an uncorrected p-value with a required threshold of 0.0125 for significance (correction factor 4)|Regression, Linear|Bonferroni multiple testing corrections were applied separately to results for our primary and secondary outcomes.||Active LFMS treatment would reduce depression immediately after treatment in subjects with major depressive disorder as assessed by the PANAS (positive scale)||5.8|1.3|0.30
72388394|NCT00578383|144284575|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.3|STANDARD_ERROR_OF_MEAN|2.01||0.52|TWO_SIDED|95.0|-4.1|6.8||we used type HC3 robust standard errors (SEs)in place of OLS regression SEs to guard against biased estimation of SEs due to heteroscedasticity. This is an uncorrected p-value with a required threshold of 0.0125 for significance (correction factor 4)|Regression, Linear|Bonferroni multiple testing corrections were applied separately to results for our primary and secondary outcomes.||Active LFMS treatment would reduce depression immediately after treatment in subjects with bipolar depression as assessed by the PANAS (negative scale)||6.8|-4.1|0.52
72388395|NCT00578383|144284576|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.2|STANDARD_ERROR_OF_MEAN|1.43||0.1||95.0|-1.3|5.8||we used type HC3 robust standard errors (SEs)in place of OLS regression SEs to guard against biased estimation of SEs due to heteroscedasticity. This is an uncorrected p-value with a required threshold of 0.0125 for significance (correction factor 4)|Regression, Linear|Bonferroni multiple testing corrections were applied separately to results for our primary and secondary outcomes.||Active LFMS treatment would reduce depression immediately after treatment in subjects with major depressive disorder as assessed by the PANAS (negative scale)||5.8|-1.3|0.10
72388396|NCT00181155|144284609|SUPERIORITY_OR_OTHER||||||<|0.007||95.0||||vs. baseline|Two-sided paired t tests|||||||<0.007
72388397|NCT00181155|144284610|SUPERIORITY_OR_OTHER||||||<|0.02||95.0||||vs. baseline|Two-sided paired t tests|||||||<0.02
72496471|NCT01360645|144522684|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.63||||0.0001|TWO_SIDED|95.0|-3.96|-1.3|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||Statistical analysis for Week 11||-1.30|-3.96|0.0001
72442503|NCT04714320|144397614|SUPERIORITY||||||=|0.83||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg and DBP ≤ 80 mmHg at Day 50||||=0.830
72442504|NCT04714320|144397614|SUPERIORITY||||||=|0.209||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg and DBP ≤ 80 mmHg at Day 57||||=0.209
72442505|NCT04714320|144397614|SUPERIORITY||||||=|0.809||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg and DBP ≤ 80 mmHg at Day 57||||=0.809
72442506|NCT04714320|144397614|SUPERIORITY||||||=|0.045||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg and DBP ≤ 80 mmHg at Day 64||||=0.045
72442507|NCT04714320|144397614|SUPERIORITY||||||=|0.104||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg and DBP ≤ 80 mmHg at Day 64||||=0.104
72442508|NCT04714320|144397614|SUPERIORITY||||||=|0.69||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg and DBP ≤ 80 mmHg at Day 71||||=0.690
72442509|NCT04714320|144397614|SUPERIORITY||||||=|0.59||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg and DBP ≤ 80 mmHg at Day 71||||=0.590
72442510|NCT04714320|144397614|SUPERIORITY||||||=|0.538||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg and DBP ≤ 80 mmHg at Day 78||||=0.538
72442511|NCT04714320|144397614|SUPERIORITY||||||=|0.407||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg and DBP ≤ 80 mmHg at Day 78||||=0.407
72442512|NCT04714320|144397614|SUPERIORITY||||||=|0.398||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg and DBP ≤ 80 mmHg at Day 85||||=0.398
72442513|NCT04714320|144397614|SUPERIORITY||||||=|0.93||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg and DBP ≤ 80 mmHg at Day 85||||=0.930
72442514|NCT04714320|144397614|SUPERIORITY||||||=|0.111||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg and DBP ≤ 80 mmHg at Day 92||||=0.111
72442515|NCT04714320|144397614|SUPERIORITY||||||=|0.196||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg and DBP ≤ 80 mmHg at Day 92||||=0.196
72442516|NCT04714320|144397614|SUPERIORITY||||||=|0.816||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg and DBP ≤ 80 mmHg at Day 106||||=0.816
72442517|NCT04714320|144397614|SUPERIORITY||||||=|0.473||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg and DBP ≤ 80 mmHg at Day 106||||=0.473
72442518|NCT04714320|144397614|SUPERIORITY||||||=|0.615||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg and DBP ≤ 80 mmHg at Day 120||||=0.615
72442519|NCT04714320|144397614|SUPERIORITY||||||=|0.214||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg and DBP ≤ 80 mmHg at Day 120||||=0.214
72442520|NCT04714320|144397614|SUPERIORITY||||||=|0.575||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg and DBP ≤ 80 mmHg at Day 148||||=0.575
72619099|NCT03156621|144768946|SUPERIORITY||Least squares (LS) mean difference|-32.9|STANDARD_ERROR_OF_MEAN|7.4|||TWO_SIDED|95.0|-47.6|-18.2||||||||-18.2|-47.6|
72442521|NCT04714320|144397614|SUPERIORITY||||||=|0.276||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg and DBP ≤ 80 mmHg at Day 148||||=0.276
72442522|NCT04714320|144397614|SUPERIORITY||||||=|0.573||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg and DBP ≤ 80 mmHg at Day 169||||=0.573
72442523|NCT04714320|144397614|SUPERIORITY||||||=|0.706||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg and DBP ≤ 80 mmHg at Day 169||||=0.706
72442524|NCT04714320|144397615|SUPERIORITY||||||=|0.853||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables|ANCOVA|||Change from Baseline at Day 8||||=0.853
72442525|NCT04714320|144397615|SUPERIORITY||||||=|0.542||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 8||||=0.542
72442526|NCT04714320|144397615|SUPERIORITY||||||=|0.43||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 15||||=0.430
72442527|NCT04714320|144397615|SUPERIORITY||||||=|0.587||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 15||||=0.587
72442528|NCT04714320|144397615|SUPERIORITY||||||=|0.91||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 22||||=0.910
72442529|NCT04714320|144397615|SUPERIORITY||||||=|0.846||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 22||||=0.846
72442530|NCT04714320|144397615|SUPERIORITY|||||||0.634||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 29||||0.634
72442531|NCT04714320|144397615|SUPERIORITY||||||=|0.767||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 29||||=0.767
72442532|NCT04714320|144397615|SUPERIORITY||||||=|0.399||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 36||||=0.399
72442533|NCT04714320|144397615|SUPERIORITY||||||=|0.323||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 36||||=0.323
72442534|NCT04714320|144397615|SUPERIORITY||||||=|0.115||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 43||||=0.115
72442535|NCT04714320|144397615|SUPERIORITY||||||=|0.982||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 43||||=0.982
72442536|NCT04714320|144397615|SUPERIORITY||||||=|0.859||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 50||||=0.859
72442537|NCT04714320|144397615|SUPERIORITY||||||=|0.344||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 50||||=0.344
72442538|NCT04714320|144397615|SUPERIORITY||||||=|0.633||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 57||||=0.633
72619100|NCT03156621|144768947|SUPERIORITY||Least squares (LS) mean difference|-26.5|STANDARD_ERROR_OF_MEAN|6.2|||TWO_SIDED|95.0|-28.9|-14.0||||||||-14.0|-28.9|
72442539|NCT04714320|144397615|SUPERIORITY||||||=|0.889||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 57||||=0.889
72442540|NCT04714320|144397615|SUPERIORITY||||||=|0.241||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 64||||=0.241
72442541|NCT04714320|144397615|SUPERIORITY||||||=|0.367||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 64||||=0.367
72442542|NCT04714320|144397615|SUPERIORITY||||||=|0.716||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 71||||=0.716
72442543|NCT04714320|144397615|SUPERIORITY||||||=|0.21||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 71||||=0.210
72619101|NCT03156621|144768948|SUPERIORITY||Mean Difference (Final Values)|-28.4|STANDARD_ERROR_OF_MEAN|6.7|||TWO_SIDED|95.0|-41.5|-15.2||||||||-15.2|-41.5|
72619102|NCT03156621|144768949|SUPERIORITY||Least squares (LS) mean difference|3.6|STANDARD_ERROR_OF_MEAN|3.8|||TWO_SIDED|95.0|-4.1|11.3||||||||11.3|-4.1|
72442544|NCT04714320|144397615|SUPERIORITY||||||=|0.363||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 78||||=0.363
72442545|NCT04714320|144397615|SUPERIORITY||||||=|0.193||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 78||||=0.193
72442546|NCT04714320|144397615|SUPERIORITY||||||=|0.135||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 85||||=0.135
72442547|NCT04714320|144397615|SUPERIORITY||||||=|0.867||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 85||||=0.867
72442548|NCT04714320|144397615|SUPERIORITY||||||=|0.761||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 92||||=0.761
72442549|NCT04714320|144397615|SUPERIORITY||||||=|0.618||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 92||||=0.618
72442550|NCT04714320|144397615|SUPERIORITY||||||=|0.363||||||The stratification factor (screening eGFR status (\<60 vs ≥60 mL/min/1.73 m2)) and treatment received are included in the Van Elteren model as independent variables.|Van Elteren|||Change from Baseline at Day 106||||=0.363
72442551|NCT04714320|144397615|SUPERIORITY||||||=|0.125||||||The stratification factor (screening eGFR status (\<60 vs ≥60 mL/min/1.73 m2)) and treatment received are included in the Van Elteren model as independent variables.|Van Elteren|||Change from Baseline at Day 106||||=0.125
72442552|NCT04714320|144397615|SUPERIORITY||||||=|0.435||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 120||||=0.435
72442553|NCT04714320|144397615|SUPERIORITY||||||=|0.413||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 120||||=0.413
72442554|NCT04714320|144397615|SUPERIORITY||||||=|0.658||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 148||||=0.658
72442555|NCT04714320|144397615|SUPERIORITY||||||=|0.275||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 148||||=0.275
72442556|NCT04714320|144397615|SUPERIORITY||||||=|0.578||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 169||||=0.578
72442557|NCT04714320|144397615|SUPERIORITY||||||=|0.114||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 169||||=0.114
72442558|NCT04714320|144397616|SUPERIORITY||||||=|0.378||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 8||||=0.378
72442559|NCT04714320|144397616|SUPERIORITY||||||=|0.648||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 8||||=0.648
72442560|NCT04714320|144397616|SUPERIORITY||||||=|0.961||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 15||||=0.961
72442561|NCT04714320|144397616|SUPERIORITY||||||=|0.817||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 15||||=0.817
72442562|NCT04714320|144397616|SUPERIORITY||||||=|0.823||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 22||||=0.823
72442563|NCT04714320|144397616|SUPERIORITY||||||=|0.362||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 22||||=0.362
72442564|NCT04714320|144397616|SUPERIORITY||||||=|0.66||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 29||||=0.660
72442565|NCT04714320|144397616|SUPERIORITY||||||=|0.539||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 29||||=0.539
72442566|NCT04714320|144397616|SUPERIORITY||||||=|0.43||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 36||||=0.430
72442567|NCT04714320|144397616|SUPERIORITY||||||=|0.594||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 36||||=0.594
72619103|NCT03156621|144768950|SUPERIORITY||Mean Difference (Final Values)|-11.3|STANDARD_ERROR_OF_MEAN|7.1|||TWO_SIDED|95.0|-25.2|2.6||||||||2.6|-25.2|
72559728|NCT02906813|144649614|SUPERIORITY_OR_OTHER||LS Mean Ratio|0.889||||0.281|TWO_SIDED|90.0|0.738|1.07|||ANOVA|||ANOVA was performed on natural logarithms of TAK-935 AUCt with factors of sequence, period, and regimen and random factor of participant nested within sequence. Pairwise comparisons was used to assess relative BA of TAK-935 administered after high-fat meal versus fasted. Point estimate and its 90% CI in original scale were obtained by exponentiation of differences in natural-log scale.||1.070|0.738|0.281
72559729|NCT02906813|144649615|SUPERIORITY_OR_OTHER||LS Mean Ratio|0.842||||0.191|TWO_SIDED|90.0|0.676|1.05|||ANOVA|||ANOVA was performed on natural logarithms of TAK-935 AUC∞ with fixed factors of sequence, period, and regimen and random factor of participant nested within sequence. Pairwise comparisons was used to assess relative BA of TAK-935 tablet to solution. Point estimate and 90% CI in original scale were obtained by exponentiation of differences in natural-log scale.||1.050|0.676|0.191
72442568|NCT04714320|144397616|SUPERIORITY||||||=|0.783||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 43||||=0.783
72442569|NCT04714320|144397616|SUPERIORITY||||||=|0.599||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 43||||=0.599
72442570|NCT04714320|144397616|SUPERIORITY||||||=|0.454||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 50||||=0.454
72442571|NCT04714320|144397616|SUPERIORITY||||||=|0.394||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 50||||=0.394
72442572|NCT04714320|144397616|SUPERIORITY||||||=|0.93||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 57||||=0.930
72442573|NCT04714320|144397616|SUPERIORITY||||||=|0.313||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 57||||=0.313
72442574|NCT04714320|144397616|SUPERIORITY||||||=|0.276||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 64||||=0.276
72496472|NCT01360645|144522684|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.59||||0.0004|TWO_SIDED|95.0|-4.01|-1.18|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||Statistical analysis for Week 12||-1.18|-4.01|0.0004
72619104|NCT03156621|144768951|SUPERIORITY||Least squares (LS) mean difference|3.6|STANDARD_ERROR_OF_MEAN|3.6|||TWO_SIDED|95.0|-3.6|10.7||||||||10.7|-3.6|
72442575|NCT04714320|144397616|SUPERIORITY||||||=|0.168||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 64||||=0.168
72442576|NCT04714320|144397616|SUPERIORITY||||||=|0.199||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 71||||=0.199
72442577|NCT04714320|144397616|SUPERIORITY||||||=|0.506||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 71||||=0.506
72442578|NCT04714320|144397616|SUPERIORITY||||||=|0.32||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 78||||=0.320
72442579|NCT04714320|144397616|SUPERIORITY||||||=|0.25||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 78||||=0.250
72442580|NCT04714320|144397616|SUPERIORITY||||||=|0.373||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 85||||=0.373
72442581|NCT04714320|144397616|SUPERIORITY||||||=|0.597||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 85||||=0.597
72619105|NCT03156621|144768952|SUPERIORITY||Odds Ratio (OR)|12.2|||||TWO_SIDED|95.0|3.1|48.8||||||≥15% reduction||48.8|3.1|
72619106|NCT03156621|144768952|SUPERIORITY|≥ 30% reduction|Odds Ratio (OR)|36.5|||||TWO_SIDED|95.0|4.3|308.9||||||||308.9|4.3|
72442582|NCT04714320|144397616|SUPERIORITY||||||=|0.867||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 92||||=0.867
72442583|NCT04714320|144397616|SUPERIORITY||||||=|0.5||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 92||||=0.500
72442584|NCT04714320|144397616|SUPERIORITY||||||=|0.863||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 106||||=0.863
72442585|NCT04714320|144397616|SUPERIORITY||||||=|0.681||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 106||||=0.681
72442586|NCT04714320|144397616|SUPERIORITY||||||=|0.262||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 120||||=0.262
72559730|NCT02906813|144649615|SUPERIORITY_OR_OTHER||LS Mean Ratio|0.894||||0.355||90.0|0.726|1.1|||ANOVA|||ANOVA was performed on natural logarithms of TAK-935 AUC∞ with factors of sequence, period, and regimen and random factor of participant nested within sequence. Pairwise comparisons was used to assess relative BA of TAK-935 administered after high-fat meal versus fasted. Point estimate and its 90% CI in original scale were obtained by exponentiation of differences in natural-log scale.||1.100|0.726|0.355
72442587|NCT04714320|144397616|SUPERIORITY||||||=|0.645||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 120||||=0.645
72442588|NCT04714320|144397616|SUPERIORITY||||||=|0.947||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 148||||=0.947
72442589|NCT04714320|144397616|SUPERIORITY||||||=|0.665||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 148||||=0.665
72442590|NCT04714320|144397616|SUPERIORITY||||||=|0.498||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 169||||=0.498
72442591|NCT04714320|144397616|SUPERIORITY||||||=|0.173||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 169||||=0.173
72442592|NCT03088813|144397619|OTHER||Hazard Ratio (HR)|1.11||||0.3094|TWO_SIDED|95.0|0.9|1.37|||Stratified log-rank test|From stratified log-rank test, stratified by corrected region and corrected platinum sensitivity.|The associated HR and two-sided 95% Confidence Interval (CI) were estimated using stratified Cox proportional hazards model, stratified by corrected region and corrected platinum sensitivity.|||1.37|0.90|0.3094
72442593|NCT03088813|144397623|OTHER||Hazard Ratio (HR)|0.96||||0.7053|TWO_SIDED|95.0|0.77|1.2||From stratified log-rank test, stratified by corrected region and corrected platinum sensitivity|Stratified log-rank test||The associated HR and two-sided 95% CI were estimated using stratified Cox proportional hazards model, stratified by corrected region and corrected platinum sensitivity.|||1.20|0.77|0.7053
72442594|NCT03088813|144397624|OTHER||Difference in ORR|22.29|||<|0.0001|TWO_SIDED|95.0|13.97|30.61||ORR difference, 95% CI and P-value are obtained from the Cochran-Mantel-Haenszel test stratified by corrected region and corrected platinum sensitivity.|Cochran-Mantel-Haenszel|||||30.61|13.97|<0.0001
72442595|NCT03363854|144397642|SUPERIORITY||Risk Difference (RD)|12.4||||0.015|TWO_SIDED|95.0|2.9|21.9||The primary endpoints were tested sequentially at a 5% significance level.|Cochran-Mantel-Haenszel|The analysis was conducted using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity.||Participants who achieved IGA 0 or 1 at Week 16 were defined as responders. Participants with missing data at Week 16 or who received rescue medication prior to Week 16 were defined as non-responders, independently of their IGA value at Week 16. The null hypothesis of no difference in response rates between tralokinumab Q2W+TCS and placebo+TCS was tested against the 2-sided alternative that there was a difference.||21.9|2.9|0.015
72442596|NCT03363854|144397643|SUPERIORITY||Risk Difference (RD)|20.2|||<|0.001|TWO_SIDED|95.0|9.8|30.6||The primary endpoints were tested sequentially at a 5% significance level.|Cochran-Mantel-Haenszel|The analysis was conducted using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity.||Participants who achieved at least 75% reduction in EASI at Week 16 were defined as responders. Participants with missing data at Week 16 or who received rescue medication prior to Week 16 were defined as non-responders, independently of their EASI value at Week 16. The null hypothesis of no difference in response rates between tralokinumab Q2W+TCS and placebo+TCS was tested against the 2-sided alternative that there was a difference.||30.6|9.8|<0.001
72442597|NCT03363854|144397644|SUPERIORITY||Risk Difference (RD)|11.3||||0.037|TWO_SIDED|95.0|0.9|21.6||This secondary endpoint was tested after the sequential testing of the primary endpoints, if these showed statistical significance.|Cochran-Mantel-Haenszel|The analysis was conducted using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity.||Participants meeting the endpoint were defined as responders. Participants with missing data at Week 16 or who received rescue medication prior to Week 16 were defined as non-responders, independently of their Worst daily Pruritus NRS value at Week 16.||21.6|0.9|0.037
72442598|NCT03363854|144397645|SUPERIORITY||Difference|-10.9|||<|0.001|TWO_SIDED|95.0|-15.2|-6.6||This secondary endpoint was tested sequentially using the Holm method for multiplicity adjustment at a 5% significance level after the sequential testing of the primary endpoints and first secondary endpoint, if these showed statistical significance.|Repeated measurements model|||Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included.||-6.6|-15.2|<0.001
72442599|NCT03363854|144397646|SUPERIORITY||Difference|-2.9|||<|0.001|TWO_SIDED|95.0|-4.3|-1.6||This secondary endpoint was tested sequentially using the Holm method for multiplicity adjustment at a 5% significance level after sequential testing of the primary endpoints and the first secondary endpoint, if these showed statistical significance.|Repeated measurements model|||Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included.||-1.6|-4.3|<0.001
72442600|NCT03363854|144397648|SUPERIORITY||Difference|-3.5||||0.41|TWO_SIDED|95.0|-11.9|4.9||The statistical test was not controlled for multiplicity.|Repeated measurements model|||Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included. Results of Week 1-2 are reported below.||4.9|-11.9|0.41
72442601|NCT03363854|144397648|SUPERIORITY||Difference|-6.9||||0.033|TWO_SIDED|95.0|-13.3|-0.6||The statistical test was not controlled for multiplicity.|Repeated measurements model|||Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included. Results of Week 3-4 are reported below.||-0.6|-13.3|0.033
72559731|NCT04364854|144649690|OTHER|This study was not designed to perform a hypothesis test. No p-values will be reported.|Mean Difference (Net)|-0.22|||||TWO_SIDED|95.0|-2.31|1.87|||||Analyzed using a repeated measures model that included the following fixed affects: categorical visit by treatment group interaction, site, baseline aphasia severity score, baseline VPM, and age.|||1.87|-2.31|
72442602|NCT03363854|144397648|SUPERIORITY||Difference|-4.7||||0.12|TWO_SIDED|95.0|-10.6|1.2||The statistical test was not controlled for multiplicity.|Repeated measurements model|||Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included. Results of Week 5-6 are reported below.||1.2|-10.6|0.12
72496473|NCT01360645|144522684|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.19||||0|TWO_SIDED|95.0|-4.68|-1.7|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||Statistical analysis for Week 13||-1.70|-4.68|0.0000
72496474|NCT01360645|144522685|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.31||||0.0086|TWO_SIDED|95.0|-2.28|-0.34|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||Statistical analysis for Week 9||-0.34|-2.28|0.0086
72442603|NCT03363854|144397648|SUPERIORITY||Difference|-7.3||||0.043|TWO_SIDED|95.0|-14.3|-0.2||The statistical test was not controlled for multiplicity.|Repeated measurements model|||Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included. Results of Week 7-8 are reported below.||-0.2|-14.3|0.043
72442604|NCT03363854|144397648|SUPERIORITY||Difference|-9.1||||0.002|TWO_SIDED|95.0|-14.8|-3.4||The statistical test was not controlled for multiplicity.|Repeated measurements model|||Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included. Results of Week 9-10 are reported below.||-3.4|-14.8|0.002
72442605|NCT03363854|144397648|SUPERIORITY||Difference|-8.0||||0.001|TWO_SIDED|95.0|-12.8|-3.2||The statistical test was not controlled for multiplicity.|Repeated measurements model|||Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included. Results of Week 11-12 are reported below.||-3.2|-12.8|0.001
72442606|NCT03363854|144397648|SUPERIORITY||Difference|-10.2|||<|0.001|TWO_SIDED|95.0|-15.8|-4.7||The statistical test was not controlled for multiplicity.|Repeated measurements model|||Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included. Results of Week 13-14 are reported below.||-4.7|-15.8|<0.001
72442607|NCT03363854|144397648|SUPERIORITY||Difference|-8.6||||0.002|TWO_SIDED|95.0|-14.1|-3.2||The statistical test was not controlled for multiplicity.|Repeated measurements model|||Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included. Results of Week 15-16 are reported below.||-3.2|-14.1|0.002
72442608|NCT03363854|144397649|SUPERIORITY||Difference|0.0||||1|TWO_SIDED|95.0|-11.0|11.0||The statistical test was not controlled for multiplicity.|Repeated measurements model|||Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included. Results of Week 1-2 are reported below.||11.0|-11.0|1.00
72442609|NCT03363854|144397649|SUPERIORITY||Difference|1.1||||0.83|TWO_SIDED|95.0|-9.1|11.4||The statistical test was not controlled for multiplicity.|Repeated measurements model|||Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included. Results of Week 3-4 are reported below.||11.4|-9.1|0.83
72442610|NCT03363854|144397649|SUPERIORITY||Difference|-1.4||||0.78|TWO_SIDED|95.0|-11.3|8.5||The statistical test was not controlled for multiplicity.|Repeated measurements model|||Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included. Results of Week 5-6 are reported below.||8.5|-11.3|0.78
72442611|NCT03363854|144397649|SUPERIORITY||Difference|-4.8||||0.34|TWO_SIDED|95.0|-14.8|5.1||The statistical test was not controlled for multiplicity.|Repeated measurements model|||Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included. Results of Week 7-8 are reported below.||5.1|-14.8|0.34
72442612|NCT03363854|144397649|SUPERIORITY||Difference|-4.4||||0.34|TWO_SIDED|95.0|-13.4|4.6||The statistical test was not controlled for multiplicity.|Repeated measurements model|||Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included. Results of Week 9-10 are reported below.||4.6|-13.4|0.34
72442613|NCT03363854|144397649|SUPERIORITY||Difference|-6.2||||0.11|TWO_SIDED|95.0|-13.9|1.5||The statistical test was not controlled for multiplicity.|Repeated measurements model|||Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included. Results of Week 11-12 are reported below.||1.5|-13.9|0.11
72442614|NCT03363854|144397649|SUPERIORITY||Difference|-8.9||||0.024|TWO_SIDED|95.0|-16.6|-1.2||The statistical test was not controlled for multiplicity.|Repeated measurements model|||Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included. Results of Week 13-14 are reported below.||-1.2|-16.6|0.024
72442615|NCT03363854|144397649|SUPERIORITY||Difference|-9.5||||0.017|TWO_SIDED|95.0|-17.3|-1.7||The statistical test was not controlled for multiplicity.|Repeated measurements model|||Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included. Results of Week 15-16 are reported below.||-1.7|-17.3|0.017
72619107|NCT03156621|144768952|SUPERIORITY||Odds Ratio (OR)|17.7|||||TWO_SIDED|95.0|3.3||Maximum likelihood estimate does not exist|||||≥ 50% reduction|||3.3|
72442616|NCT03363854|144397651|SUPERIORITY||Difference|0.1||||0.64|TWO_SIDED|95.0|-0.5|0.7||The statistical test was not controlled for multiplicity.|Repeated measurements model|||Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included. Results of Week 1 are reported below.||0.7|-0.5|0.64
72442617|NCT03363854|144397651|SUPERIORITY||Difference|0.4||||0.26|TWO_SIDED|95.0|-0.3|1.0||The statistical test was not controlled for multiplicity.|Repeated measurements model|||Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included. Results of Week 2 are reported below.||1.0|-0.3|0.26
72496475|NCT01360645|144522685|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.52||||0.0149|TWO_SIDED|95.0|-2.74|-0.3|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||Statistical analysis for Week 10||-0.30|-2.74|0.0149
72619108|NCT03156621|144768953|SUPERIORITY||Least squares (LS) mean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.1|||TWO_SIDED|95.0|-0.6|-0.1||||||||-0.1|-0.6|
72619109|NCT03757715|144768956|SUPERIORITY|||||||0.16|||||||t-test, 1 sided|||||||0.16
72559732|NCT04364854|144649690|OTHER|This study was not designed to perform a hypothesis test. No p-values will be reported.|Mean Difference (Net)|0.1|||||TWO_SIDED|95.0|-2.94|3.15|||||Analyzed using a repeated measures model that included the following fixed affects: categorical visit by treatment group interaction, site, baseline aphasia severity score, baseline VPM, and age.|||3.15|-2.94|
72559733|NCT04364854|144649690|OTHER|This study was not designed to perform a hypothesis test. No p-values will be reported.|Mean Difference (Net)|-0.78|||||TWO_SIDED|95.0|-2.9|1.33|||||Analyzed using a repeated measures model that included the following fixed affects: categorical visit by treatment group interaction, site, baseline aphasia severity score, baseline VPM, and age.|||1.33|-2.9|
72559734|NCT04364854|144649691|OTHER|This trial was not designed for hypothesis testing. No p-values will be reported.|Mean Difference (Net)|-0.07|||||TWO_SIDED|95.0|-0.26|0.13|||||Analyzed using a repeated measures model that included the following fixed affects: categorical visit by treatment group interaction, site, baseline aphasia severity score, baseline SAQOL-39, and age.|||0.13|-0.26|
72442618|NCT03363854|144397651|SUPERIORITY||Difference|0.2||||0.46|TWO_SIDED|95.0|-0.4|0.8||The statistical test was not controlled for multiplicity.|Repeated measurements model|||Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included. Results of Week 3 are reported below.||0.8|-0.4|0.46
72442619|NCT03363854|144397651|SUPERIORITY||Difference|0.4||||0.16|TWO_SIDED|95.0|-0.2|1.0||The statistical test was not controlled for multiplicity.|Repeated measurements model|||Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included. Results of Week 4 are reported below.||1.0|-0.2|0.16
72442620|NCT03363854|144397651|SUPERIORITY||Difference|0.5||||0.13|TWO_SIDED|95.0|-0.1|1.1||The statistical test was not controlled for multiplicity.|Repeated measurements model|||Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included. Results of Week 5 are reported below.||1.1|-0.1|0.13
72559735|NCT04364854|144649691|OTHER|This trial was not designed for hypothesis testing. No p-values will be reported.|Mean Difference (Net)|0.03|||||TWO_SIDED|95.0|-0.21|0.28|||||Analyzed using a repeated measures model that included the following fixed affects: categorical visit by treatment group interaction, site, baseline aphasia severity score, baseline SAQOL-39, and age.|||0.28|-0.21|
72559736|NCT04364854|144649691|OTHER|This trial was not designed for hypothesis testing. No p-values will be reported.|Mean Difference (Net)|-0.23|||||TWO_SIDED|95.0|-0.42|-0.04|||||Analyzed using a repeated measures model that included the following fixed affects: categorical visit by treatment group interaction, site, baseline aphasia severity score, baseline SAQOL-39, and age.|||-0.04|-0.42|
72559737|NCT04364854|144649692|OTHER|This trial was not designed for hypothesis testing. No p-values will be reported.|Mean Difference (Net)|0.16|||||TWO_SIDED|95.0|-2.59|2.9|||||Analyzed using a repeated measures model that included the following fixed affects: categorical visit by treatment group interaction, site, baseline aphasia severity score, baseline VPM - Narrative, and age.|||2.9|-2.59|
72559738|NCT04364854|144649692|OTHER|This trial was not designed for hypothesis testing. No p-values will be reported.|Mean Difference (Net)|0.79|||||TWO_SIDED|95.0|-2.23|3.8|||||Analyzed using a repeated measures model that included the following fixed affects: categorical visit by treatment group interaction, site, baseline aphasia severity score, baseline VPM-Narrative, and age.|||3.8|-2.23|
72619110|NCT03757715|144768957|SUPERIORITY|||||||0.42|||||||t-test, 1 sided|||||||0.42
72619111|NCT01550965|144769007|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|17.4|||<|0.001|TWO_SIDED|95.0|16.08|18.73|||paired t-test, 2 sided|||Hypothesis testing for the first ranked primary outcome was performed in a hierarchical order using the two-sided paired t-test for mean change equal to zero.||18.73|16.08|<0.001
72619112|NCT01550965|144769008|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1383.81|||<|0.001|TWO_SIDED|95.0|-1586.36|-1181.26|||Paired t-test, 2 sided|||Hypothesis testing for the second ranked primary outcome was performed in a hierarchical order using the two-sided paired t-test for mean change equal to zero.||-1181.26|-1586.36|<0.001
72388398|NCT01323959|144284639|SUPERIORITY_OR_OTHER||Percentage of subjects seroprotected|96.8|||||TWO_SIDED|95.0|89.0|99.6|||||The pre-specified lower limit (LL) of the 95% confidence interval (CI) for the percentage of seroprotected (Anti-D concentrations ≥ 0.1 IU/mL by ELISA or ≥ 0.01 IU/mL by VERO-cell when subjects with ELISA result \<0.1 IU/mL) subjects was above 80%.|"The objective of the analysis was to demonstrate that a booster dose of Boostrix™ Polio vaccine, administered to adults 10 years after a dose of Boostrix™ Polio vaccine or co-administered Boostrix™ + Poliorix™ vaccines, elicited seroprotective antibody concentrations, 1 month after the booster dose, in at least 80% of the subjects against diphtheria.~Samples were analysed both with ELISA (enzyme-linked immunosorbent assay), and VERO-cell (African green monkey kidney cell) neutralisation testing."||99.6|89|
72388399|NCT01323959|144284639|SUPERIORITY_OR_OTHER||Percentage of subjects seroprotected|95.7|||||TWO_SIDED|95.0|87.8|99.1|||||The pre-specified lower limit (LL) of the 95% confidence interval (CI) for the percentage of seroprotected (Anti-D concentrations ≥ 0.1 IU/mL by ELISA or ≥ 0.01 IU/mL by VERO-cell when subjects with ELISA result \<0.1 IU/mL) subjects was above 80%.|The objective of the analysis was to demonstrate that a booster dose of Boostrix™ Polio vaccine, administered to adults 10 years after a dose of Boostrix™ Polio vaccine or co-administered Boostrix™ + Poliorix™ vaccines, elicited seroprotective antibody concentrations, one month after the booster dose, in at least 80% of the subjects against diphtheria.||99.1|87.8|
72388400|NCT01323959|144284639|SUPERIORITY_OR_OTHER||Percentage of subjects seroprotected|100.0|||||TWO_SIDED|95.0|94.8|100.0|||||The pre-specified lower limit (LL) of the 95% confidence interval (CI) for the percentage of seroprotected (Anti-D concentrations ≥ 0.1 IU/mL by ELISA or ≥ 0.01 IU/mL by VERO-cell when subjects with ELISA result \<0.1 IU/mL) subjects was above 80%.|The objective of the analysis was to demonstrate that a booster dose of Boostrix™ Polio vaccine, administered to adults 10 years after a dose of Boostrix™ Polio vaccine or co-administered Boostrix™ + Poliorix™ vaccines, elicited seroprotective antibody concentrations, one month after the booster dose, in at least 80% of the subjects against diphtheria.||100|94.8|
72388401|NCT01323959|144284641|SUPERIORITY_OR_OTHER||Percentage of subjects seroprotected|92.1|||||TWO_SIDED|95.0|82.4|97.4|||||The pre-specified lower limit (LL) of the 95% confidence interval (CI) for the percentage of seroprotected (Anti-D concentrations ≥ 0.1 IU/mL by ELISA or ≥ 0.01 IU/mL by VERO-cell when subjects with ELISA result \<0.1 IU/mL) subjects was above 80%.|The objective of the analysis was to dose in study NCT01277705. Samples were analysed both with ELISA (enzyme-linked immunosorbent assay), and VERO-cell (African green monkey kidney cell) neutralisation testing.||97.4|82.4|
72559739|NCT04364854|144649692|OTHER|This trial was not designed for hypothesis testing. No p-values will be reported.|Mean Difference (Net)|0.25|||||TWO_SIDED|95.0|-2.32|2.82|||||Analyzed using a repeated measures model that included the following fixed affects: categorical visit by treatment group interaction, site, baseline aphasia severity score, baseline VPM - Narrative, and age.|||2.82|-2.32|
72559740|NCT04364854|144649693|OTHER|This trial was not designed for hypothesis testing. No p-values will be reported.|Mean Difference (Net)|-0.07|||||TWO_SIDED|95.0|-3.59|3.45|||||Analyzed using a repeated measures model that included the following fixed affects: categorical visit by treatment group interaction, site, baseline aphasia severity score, baseline VPM - Procedural, and age.|||3.45|-3.59|
72442621|NCT03363854|144397651|SUPERIORITY||Difference|0.3||||0.38|TWO_SIDED|95.0|-0.3|0.9||The statistical test was not controlled for multiplicity.|Repeated measurements model|||Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included. Results of Week 6 are reported below.||0.9|-0.3|0.38
72559741|NCT04364854|144649693|OTHER|This trial was not designed for hypothesis testing. No p-values will be reported.|Mean Difference (Net)|0.27|||||TWO_SIDED|95.0|-4.27|4.8|||||Analyzed using a repeated measures model that included the following fixed affects: categorical visit by treatment group interaction, site, baseline aphasia severity score, baseline VPM - Procedural, and age.|||4.8|-4.27|
72559742|NCT04364854|144649693|OTHER|This trial was not designed for hypothesis testing. No p-values will be reported.|Mean Difference (Net)|-2.11|||||TWO_SIDED|95.0|-5.77|1.56|||||Analyzed using a repeated measures model that included the following fixed affects: categorical visit by treatment group interaction, site, baseline aphasia severity score, baseline VPM - Procedural, and age.|||1.56|-5.77|
72559743|NCT01472432|144649694|SUPERIORITY_OR_OTHER||||||<|0.05||||||"* Vildagliptin vs Placebo at 3 months.~* Placebo baseline versus placebo 3 months.~* Vildagliptin baseline versus Vildagliptin 3 months."|t-test, 2 sided|"* Vildagliptin vs Placebo at 3 months.~* Placebo baseline versus placebo 3 months.~* Vildagliptin baseline versus Vildagliptin 3 months."||"* Vildagliptin vs Placebo at 3 months.~* Placebo baseline versus placebo 3 months.~* Vildagliptin baseline versus Vildagliptin 3 months."||||<0.05
72559744|NCT01472432|144649695|SUPERIORITY_OR_OTHER||||||<|0.05||||||"* Vildagliptin vs Placebo at 3 months.~* Placebo baseline versus placebo 3 months.~* Vildagliptin baseline versus Vildagliptin 3 months"|t-test, 2 sided|"* Vildagliptin vs Placebo at 3 months.~* Placebo baseline versus placebo 3 months.~* Vildagliptin baseline versus Vildagliptin 3 months"||"* Vildagliptin vs Placebo at 3 months.~* Placebo baseline versus placebo 3 months.~* Vildagliptin baseline versus Vildagliptin 3 months."||||<0.05
72559745|NCT01472432|144649696|SUPERIORITY_OR_OTHER||||||<|0.05||||||P-values from multiple comparisons: placebo at baseline vs. placebo at 3 months; placebo at 3 months vs. Vildagliptin at 3 months; Vildagliptin at baseline vs. Vildagliptin at 3 months. P\< 0.05 versus control patients. P \< 0.05 versus baseline.|t-test, 2 sided|||p-values from multiple comparisons: placebo at baseline vs. placebo at 3 months; placebo at 3 months vs. Vildagliptin at 3 months; Vildagliptin at baseline vs. Vildagliptin at 3 months.||||<0.05
72559746|NCT01472432|144649697|SUPERIORITY_OR_OTHER||||||<|0.05||||||P\< 0.05 versus control patients. P \< 0.05 versus baseline|t-test, 2 sided|||||||<0.05
72388402|NCT01323959|144284641|SUPERIORITY_OR_OTHER||Percentage of subjects seroprotected|79.4|||||TWO_SIDED|95.0|67.9|88.3|||||The pre-specified lower limit (LL) of the 95% confidence interval (CI) for the percentage of seroprotected (Anti-D concentrations ≥ 0.1 IU/mL by ELISA or ≥ 0.01 IU/mL by VERO-cell when subjects with ELISA result \<0.1 IU/mL) subjects was above 80%.|The objective of the analysis was to demonstrate that a booster dose of Boostrix™ Polio vaccine, administered to adults 10 years after a dose of Boostrix™ Polio vaccine or co-administered Boostrix™ + Poliorix™ vaccines, elicited seroprotective antibody concentrations, one month after the booster dose, in at least 80% of the subjects against diphtheria.||88.3|67.9|
72442622|NCT03363854|144397651|SUPERIORITY||Difference|0.6||||0.04|TWO_SIDED|95.0|0.0|1.2||The statistical test was not controlled for multiplicity.|Repeated measurements model|||Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included. Results of Week 7 are reported below.||1.2|0.0|0.040
72442623|NCT03363854|144397651|SUPERIORITY||Difference|0.3||||0.31|TWO_SIDED|95.0|-0.3|1.0||The statistical test was not controlled for multiplicity.|Repeated measurements model|||Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included. Results of Week 8 are reported below.||1.0|-0.3|0.31
72442624|NCT03363854|144397651|SUPERIORITY||Difference|1.0||||0.001|TWO_SIDED|95.0|0.4|1.6||The statistical test was not controlled for multiplicity.|Repeated measurements model|||Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included. Results of Week 9 are reported below.||1.6|0.4|0.001
72442625|NCT03363854|144397651|SUPERIORITY||Difference|0.7||||0.026|TWO_SIDED|95.0|0.1|1.3||The statistical test was not controlled for multiplicity.|Repeated measurements model|||Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included. Results of Week 10 are reported below.||1.3|0.1|0.026
72442626|NCT03363854|144397651|SUPERIORITY||Difference|0.9||||0.006|TWO_SIDED|95.0|0.2|1.5||The statistical test was not controlled for multiplicity.|Repeated measurements model]|||Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included. Results of Week 11 are reported below.||1.5|0.2|0.006
72442627|NCT03363854|144397651|SUPERIORITY||Difference|0.6||||0.043|TWO_SIDED|95.0|0.0|1.3||The statistical test was not controlled for multiplicity.|Repeated measurements model|||Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included. Results of Week 12 are reported below.||1.3|0.0|0.043
72559747|NCT01390415|144649701|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0374||95.0|||||t-test, 2 sided|||Between-group comparison of Change from Baseline at Month 6||||0.0374
72559748|NCT01390415|144649702|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0566||95.0|||||t-test, 2 sided|||Between-group comparison of Change from Baseline at Month 6||||0.0566
72559749|NCT00396162|144649763|SUPERIORITY_OR_OTHER|||||||0.23|||||||t-test, 2 sided|||||||0.23
72559750|NCT00396162|144649764|SUPERIORITY_OR_OTHER|||||||0.31|||||||t-test, 2 sided|||||||.31
72619113|NCT01550965|144769009|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1297.77|||<|0.001|TWO_SIDED|95.0|-1562.17|-1033.36|||Paired t-test, 2 sided|||||-1033.36|-1562.17|<0.001
72442628|NCT03363854|144397651|SUPERIORITY||Difference|0.8||||0.01|TWO_SIDED|95.0|0.2|1.4||The statistical test was not controlled for multiplicity.|Repeated measurements model|||Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included. Results of Week 13 are reported below.||1.4|0.2|0.010
72442629|NCT03363854|144397651|SUPERIORITY||Difference|0.7||||0.037|TWO_SIDED|95.0|0.0|1.3||The statistical test was not controlled for multiplicity.|Repeated measurements model|||Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included. Results of Week 14 are reported below.||1.3|0.0|0.037
72442630|NCT03363854|144397651|SUPERIORITY||Difference|0.6||||0.045|TWO_SIDED|95.0|0.0|1.3||The statistical test was not controlled for multiplicity.|Repeated measurements model|||Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included. Results of Week 15 are reported below.||1.3|0.0|0.045
72442631|NCT03363854|144397651|SUPERIORITY||Difference|0.5||||0.17|TWO_SIDED|95.0|-0.2|1.1||The statistical test was not controlled for multiplicity.|Repeated measurements model|||Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included. Results of Week 16 are reported below.||1.1|-0.2|0.17
72442632|NCT03363854|144397652|SUPERIORITY||Risk Difference (RD)|21.3|||<|0.001|TWO_SIDED|95.0|11.3|31.3||The statistical test was not controlled for multiplicity.|Cochran-Mantel-Haenszel|The analysis was conducted using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity.||Participants meeting the endpoint were defined as responders. Participants with missing data at Week 16 or who received rescue medication prior to Week 16 were defined as non-responders, independently of their EASI value at Week 16.||31.3|11.3|<0.001
72442633|NCT03363854|144397653|SUPERIORITY||Risk Difference (RD)|11.4||||0.022|TWO_SIDED|95.0|2.1|20.7||The statistical test was not controlled for multiplicity.|Cochran-Mantel-Haenszel|The analysis was conducted using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity.||Participants meeting the endpoint were defined as responders. Participants with missing data at Week 16 or who received rescue medication prior to Week 16 were defined as non-responders, independently of their EASI value at Week 16.||20.7|2.1|0.022
72442634|NCT03363854|144397654|SUPERIORITY||Difference|-5.4|||<|0.001|TWO_SIDED|95.0|-7.7|-3.1||The statistical test was not controlled for multiplicity.|Repeated measurement model|||Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included.||-3.1|-7.7|<0.001
72442635|NCT03363854|144397655|SUPERIORITY||Risk Difference (RD)|22.9|||<|0.001|TWO_SIDED|95.0|12.4|33.3||The statistical test was not controlled for multiplicity.|Cochran-Mantel-Haenszel|The analysis was conducted using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity.||Partcipants meeting the endpoint were defined as responders. Participants with missing data at Week 16 or who received rescue medication prior to Week 16 were defined as non-responders, independently of their SCORAD value at Week 16.||33.3|12.4|<0.001
72442636|NCT03363854|144397656|SUPERIORITY||Risk Difference (RD)|11.1||||0.012|TWO_SIDED|95.0|3.2|19.0||The statistical test was not controlled for multiplicity.|Cochran-Mantel-Haenszel|The analysis was conducted using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity.||Participants meeting the endpoint were defined as responders. Participants with missing data at Week 16 or who received rescue medication prior to Week 16 were defined as non-responders, independently of their SCORAD value at Week 16.||19.0|3.2|0.012
72442637|NCT03363854|144397657|SUPERIORITY||Difference|-1.2|||<|0.001|TWO_SIDED|95.0|-1.7|-0.7||The statistical test was not controlled for multiplicity.|Repeated measurements model|||Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included.||-0.7|-1.7|<0.001
72442638|NCT03363854|144397658|SUPERIORITY||Risk Difference (RD)|17.6|||<|0.001|TWO_SIDED|95.0|8.0|27.1||The statistical test was not controlled for multiplicity.|Cochran-Mantel-Haenszel|The analysis was conducted using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity.||Participants meeting the endpoint were defined as responders. Participants with missing data at Week 16 or who received rescue medication prior to Week 16 were defined as non-responders, independently of their DLQI value at Week 16.||27.1|8.0|<0.001
72442639|NCT01903811|144397661|SUPERIORITY||Hazard Ratio (HR)|1.061||||0.384|TWO_SIDED|80.0|0.821|1.37||Stratified by pre-specified randomization stratification factors: 1 - 3 prior therapies vs. 4-6 prior therapies and refractory to bortezomib vs. not refractory to bortezomib.|Log Rank|One-sided stratified log rank test||||1.370|0.821|0.384
72442640|NCT01903811|144397662|SUPERIORITY||Hazard Ratio (HR)|1.149||||0.284|TWO_SIDED|80.0|0.841|1.571||Stratified by pre-specified randomization stratification factors: 1 - 3 prior therapies vs. 4-6 prior therapies and refractory to bortezomib vs. not refractory to bortezomib.|Log Rank|One-sided stratified log rank test||||1.571|0.841|0.284
72442641|NCT01903811|144397663|SUPERIORITY|||||||0.113|||||||Cochran-Mantel-Haenszel|||Compare the rate of confirmed PR or better between treatment arms.||||0.1130
72442642|NCT05986565|144397744|SUPERIORITY|||||||0.587|||||||RMANOVA|1||||||0.587
72442643|NCT05986565|144397745|SUPERIORITY|||||||0.874|||||||RMANOVA|1||||||0.874
72442644|NCT05986565|144397746|SUPERIORITY|||||||0.946|||||||RMANOVA|1||||||0.946
72442645|NCT05986565|144397747|SUPERIORITY|||||||0.267|||||||t-test, 2 sided|24||||||0.267
72442646|NCT05986565|144397748|SUPERIORITY|||||||0.187|||||||t-test, 2 sided|df=25||||||0.187
72442647|NCT05986565|144397749|SUPERIORITY|||||||0.765|||||||t-test, 2 sided|df=24||||||0.765
72442648|NCT05986565|144397750|SUPERIORITY|||||||0.06|||||||t-test, 2 sided|df=25||||||0.060
72442649|NCT05986565|144397751|SUPERIORITY|||||||0.608|||||||t-test, 2 sided|df=24||||||0.608
72442650|NCT05986565|144397752|SUPERIORITY|||||||0.638|||||||t-test, 2 sided|df=25||||||0.638
72442651|NCT00431834|144397830|SUPERIORITY_OR_OTHER||binomial proportions|37.7|||<|0.0041|ONE_SIDED|97.5|25.6|||The percent of patients off Class I and III AADs and successfully converted out of AF following treatment (ptest) will exceed the percenter of patients off Class I and III AADs and convereted out of AF, as reported in literature (pcontrol=22.1%)|Fisher Exact|||"The specific test hypothesis is as follows:~H0: ptest ≤ 22.1% Ha: ptest \> 22.1%"|||25.6|<0.0041
72496476|NCT01360645|144522685|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.42||||0.0006|TWO_SIDED|95.0|-3.78|-1.05|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||Statistical analysis for Week 11||-1.05|-3.78|0.0006
72442652|NCT00431834|144397833|SUPERIORITY_OR_OTHER||binomial proportions|5.3|||<|0.0001|ONE_SIDED|97.5||13.1||The percent of subjects following treatment, p, who experience any of the MAEs during the first 30 days following surgery, or hospital discharge, whichever is longer will be less than 23.6%.|Fisher Exact|||"The specific test hypothesis is as follows:~H0: p ≥ 23.6% Ha: p \< 23.6%"||13.1||<0.0001
72442653|NCT03628885|144397834|SUPERIORITY||||||<|0.02||||||Adjusted for mother's educational level, which differed across groups. A priori threshold for statistical significance = P\<.05|ANOVA|||||||<.02
72442654|NCT03628885|144397834|SUPERIORITY||||||=|0.07||||||Adjusted for mother's educational level, which differed across groups. A priori threshold for statistical significance = P\<.05|ANOVA|||||||=.07
72442655|NCT03628885|144397834|SUPERIORITY||||||<|0.01||||||Adjusted for mother's educational level, which differed across groups. A priori threshold for statistical significance = P\<.05|ANOVA|||Adjusted for mother's educational level, which differed across groups. A priori threshold for statistical significance = P\<.05||||<.01
72442656|NCT00792636|144397842|SUPERIORITY_OR_OTHER||Least-squares mean|-1.7|||||TWO_SIDED|95.0|-3.2|-0.3|||||Systolic Blood Pressure. The following covariates were used in this analysis: Age, Gender, Baseline migraines per month, Baseline blood pressure|||-0.3|-3.2|
72442657|NCT00792636|144397842|SUPERIORITY_OR_OTHER||Least-squares mean|-0.9|||||TWO_SIDED|95.0|-2.2|0.3|||||Diastolic Blood Pressure. The following covariates were used in this analysis: Age, Gender, Baseline migraines per month, Baseline blood pressure|||0.3|-2.2|
72442658|NCT00792636|144397842|SUPERIORITY_OR_OTHER||Least-squares mean|-1.9|||||TWO_SIDED|95.0|-3.4|-0.4|||||Systolic Blood Pressure. The following covariates were used in this analysis: Age, Gender, Baseline migraines per month, Baseline blood pressure|||-0.4|-3.4|
72442659|NCT00792636|144397842|SUPERIORITY_OR_OTHER||Least-squares mean|-0.7|||||TWO_SIDED|95.0|-2.0|0.6|||||Diastolic blood pressure. The following covariates were used in this analysis: Age, Gender, Baseline migraines per month, Baseline blood pressure|||0.6|-2.0|
72442660|NCT00792636|144397843|SUPERIORITY_OR_OTHER||Least-squares mean|-2.1|||||TWO_SIDED|95.0|-3.4|-0.8|||||Systolic blood pressure. The following covariates were used in this analysis: Age, Gender, Baseline migraines per month, Baseline blood pressure|||-0.8|-3.4|
72442661|NCT00792636|144397843|SUPERIORITY_OR_OTHER||Least-squares mean|-1.5|||||TWO_SIDED|95.0|-2.6|-0.3|||||Diastolic blood pressure. The following covariates were used in this analysis: Age, Gender, Baseline migraines per month, Baseline blood pressure|||-0.3|-2.6|
72442662|NCT00792636|144397844|SUPERIORITY_OR_OTHER||Least-squares mean|0.4|||||TWO_SIDED|95.0|-1.6|2.4|||||Systolic Blood Pressure. The following covariates were used in this analysis: Age, Gender, Baseline migraines per month, Baseline blood pressure|||2.4|-1.6|
72442663|NCT00792636|144397844|SUPERIORITY_OR_OTHER||Least-squares mean|0.5|||||TWO_SIDED|95.0|-1.2|2.2|||||Diastolic blood pressure. The following covariates were used in this analysis: Age, Gender, Baseline migraines per month, Baseline blood pressure|||2.2|-1.2|
72442664|NCT00792636|144397845|SUPERIORITY_OR_OTHER||Least-squares mean|0.3|||||TWO_SIDED|95.0|-1.7|2.2|||||Systolic Blood Pressure. The following covariates were used in this analysis: Age, Gender, Baseline migraines per month, Baseline blood pressure|||2.2|-1.7|
72442665|NCT00792636|144397845|SUPERIORITY_OR_OTHER||Least-squares mean|0.8|||||TWO_SIDED|95.0|-0.9|2.5|||||Diastolic blood pressure. The following covariates were used in this analysis: Age, Gender, Baseline migraines per month, Baseline blood pressure|||2.5|-0.9|
72496477|NCT01360645|144522685|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.52||||0.0009|TWO_SIDED|95.0|-4.0|-1.04|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||Statistical analysis for Week 12||-1.04|-4.00|0.0009
72442666|NCT00792636|144397850|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.5|||||TWO_SIDED|95.0|0.9|2.6||||||||2.6|0.9|
72496478|NCT01360645|144522685|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.28||||0|TWO_SIDED|95.0|-4.84|-3.28|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||Statistical analysis for Week 13||-3.28|-4.84|0.0000
72442667|NCT00792636|144397850|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.5|||||TWO_SIDED|95.0|0.9|2.6||||||||2.6|0.9|
72496479|NCT01360645|144522686|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.23||||0.0022|TWO_SIDED|95.0|-0.38|-0.08|||Cochran-Mantel-Haenszel|P-value and treatment difference (CI) are derived from Cochran-Mantel-Haenszel (CMH) row mean score differ test controlling for study center.||Statistical analysis for Week 9||-0.08|-0.38|0.0022
72442668|NCT00792636|144397851|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.0|||||TWO_SIDED|95.0|0.6|1.7||||||||1.7|0.6|
72442669|NCT00792636|144397851|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.3|||||TWO_SIDED|95.0|0.7|2.2||||||||2.2|0.7|
72442670|NCT00792636|144397852|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.0|||||TWO_SIDED|95.0|0.1|13.6||||||||13.6|0.1|
72442671|NCT00792636|144397852|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.8|||||TWO_SIDED|95.0|0.3|25.6||||||||25.6|0.3|
72442672|NCT00792636|144397853|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.4|||||TWO_SIDED|95.0|0.5|3.7||||||||3.7|0.5|
72442673|NCT00792636|144397853|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.6|||||TWO_SIDED|95.0|0.6|4.2||||||||4.2|0.6|
72619114|NCT01550965|144769010|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4308.32|||<|0.001|TWO_SIDED|95.0|-4985.13|-3631.51|||Paired t-test, 2 sided|||||-3631.51|-4985.13|<0.001
72442674|NCT00792636|144397854|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.14|||||TWO_SIDED|95.0|0.84|1.54||||||||1.54|0.84|
72442675|NCT00792636|144397854|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.36|||||TWO_SIDED|95.0|1.01|1.83||||||||1.83|1.01|
72442676|NCT00792636|144397855|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.88|||||TWO_SIDED|95.0|0.65|1.21||||||||1.21|0.65|
72442677|NCT00792636|144397855|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.18|||||TWO_SIDED|95.0|0.88|1.6||||||||1.60|0.88|
72442678|NCT04059042|144397866|EQUIVALENCE|Between-session pain measures were assessed with related-samples Wilcoxon signed-rank tests (Audio minus Silence). Data were not normally distributed so nonparametric tests were used.|Z score|39.0||||0.0051|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.0051
72442679|NCT04059042|144397866|EQUIVALENCE|Between-session change scores were calculated per participant as Audio minus Silence and compared between groups with independent samples Mann-Whitney U-tests. Data were not normally distributed so nonparametric tests were used.|Z score|19.0||||0.03|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.03
72496480|NCT01360645|144522686|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.22||||0.0115|TWO_SIDED|95.0|-0.38|-0.05|||Cochran-Mantel-Haenszel|P-value and treatment difference (CI) are derived from CMH row mean score differ test controlling for study center.||Statistical analysis for Week 10||-0.05|-0.38|0.0115
72442680|NCT04059042|144397867|EQUIVALENCE|Between-session pain measures were assessed with related-samples Wilcoxon signed-rank tests (Audio minus Silence). Data were not normally distributed so nonparametric tests were used.|Z score|18.0||||0.59|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.59
72442681|NCT04059042|144397867|EQUIVALENCE|Between-session change scores were calculated per participant as Audio minus Silence and compared between groups with independent samples Mann-Whitney U-tests. Data were not normally distributed so nonparametric tests were used.|Z score|14.0||||0.41|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.41
72442682|NCT04788641|144397938|OTHER||Geometric LS Mean Ratio (%)|71.1|||||TWO_SIDED|90.0|65.44|77.24|||||Result based on a mixed effect following a natural logarithmic transformation of the individual PK parameters, with period, treatment, and sequence as fixed effects, and participant nested within sequence as random effects.|Tacrolimus||77.24|65.44|
72442683|NCT04788641|144397938|OTHER||Geometric LS Mean Ratio (%)|102.9|||||TWO_SIDED|90.0|96.11|110.1|||||Result based on a mixed effect following a natural logarithmic transformation of the individual PK parameters, with period, treatment, and sequence as fixed effects, and participant nested within sequence as random effects.|Cyclosporin||110.1|96.11|
72442684|NCT04788641|144397939|OTHER||Geometric LS Mean Ratio (%)|62.91|||||TWO_SIDED|90.0|55.64|71.13|||||Result based on a mixed effect following a natural logarithmic transformation of the individual PK parameters, with period, treatment, and sequence as fixed effects, and participant nested within sequence as random effects.|Tacrolimus||71.13|55.64|
72442685|NCT04788641|144397939|OTHER||Geometric LS Mean Ratio (%)|97.23|||||TWO_SIDED|90.0|92.93|101.7|||||Result based on a mixed effect following a natural logarithmic transformation of the individual PK parameters, with period, treatment, and sequence as fixed effects, and participant nested within sequence as random effects.|Cyclosporin||101.7|92.93|
72442686|NCT04788641|144397940|OTHER||Geometric LS Mean Ratio (%)|65.57|||||TWO_SIDED|90.0|58.69|73.24|||||Result based on a mixed effect following a natural logarithmic transformation of the individual PK parameters, with period, treatment, and sequence as fixed effects, and participant nested within sequence as random effects.|Tacrolimus||73.24|58.69|
72442687|NCT04788641|144397940|OTHER||Geometric LS Mean Ratio (%)|97.04|||||TWO_SIDED|90.0|92.7|101.6|||||Result based on a mixed effect following a natural logarithmic transformation of the individual PK parameters, with period, treatment, and sequence as fixed effects, and participant nested within sequence as random effects.|Cyclosporin||101.6|92.70|
72442688|NCT04788641|144397941|OTHER||Geometric LS Mean Ratio (%)|83.86|||||TWO_SIDED|90.0|73.38|95.84|||||Result based on a mixed effect following a natural logarithmic transformation of the individual PK parameters, with period, treatment, and sequence as fixed effects, and participant nested within sequence as random effects.|Tacrolimus||95.84|73.38|
72442689|NCT04788641|144397941|OTHER||Geometric LS Mean Ratio (%)|97.55|||||TWO_SIDED|90.0|87.16|109.2|||||Result based on a mixed effect following a natural logarithmic transformation of the individual PK parameters, with period, treatment, and sequence as fixed effects, and participant nested within sequence as random effects.|Cyclosporin||109.2|87.16|
72442690|NCT04788641|144397942|OTHER||Geometric LS Mean Ratio (%)|98.42|||||TWO_SIDED|90.0|94.62|102.4|||||Result based on a mixed effect following a natural logarithmic transformation of the individual PK parameters, with period, treatment, and sequence as fixed effects, and participant nested within sequence as random effects.|Tacrolimus||102.4|94.62|
72619115|NCT01550965|144769011|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-7.3|||<|0.001|TWO_SIDED|95.0|-9.83|-4.78|||Paired t-test, 2 sided|||||-4.78|-9.83|<0.001
72442691|NCT04788641|144397942|OTHER||Geometric LS Mean Ratio (%)|94.12|||||TWO_SIDED|90.0|85.74|103.3|||||Result based on a mixed effect following a natural logarithmic transformation of the individual PK parameters, with period, treatment, and sequence as fixed effects, and participant nested within sequence as random effects.|Cyclosporin||103.3|85.74|
72442692|NCT02740231|144397944|SUPERIORITY||Adjusted mean difference|-9.49|STANDARD_DEVIATION|6.38||0.141|TWO_SIDED|95.0|-22.21|3.23||The threshold for statistical significance was p=0.05|ANCOVA||Difference between groups JTA-004 100 (2mL) minus Reference - adjusted mean change|The primary endpoint is the WOMAC® VA3.1 Pain Subscale (subscale A): the individual changes in WOMAC® VA3.1 Pain Subscale Score between Baseline and Month 6 were calculated and compared by analysis of covariance (ANCOVA), adjusted for baseline value, to the Reference group.||3.23|-22.21|0.141
72442693|NCT02740231|144397945|SUPERIORITY||Adjusted mean difference|-11.63|STANDARD_DEVIATION|5.5||0.038|TWO_SIDED|95.0|-22.6|-0.66||The threshold for statistical significance was p=0.05|ANCOVA||Difference between groups JTA-004 100 (2mL) minus Reference|||-0.66|-22.60|0.038
72442694|NCT02740231|144397946|SUPERIORITY||Adjusted mean difference|-1.48|STANDARD_DEVIATION|4.35||0.997|TWO_SIDED|95.0|-12.7|9.74||The threshold for statistical significance was p=0.05|Mixed Models Analysis|||||9.74|-12.70|0.997
72442695|NCT02740231|144397947|SUPERIORITY||Adjusted mean difference|-2.94|STANDARD_DEVIATION|5.3||0.972|TWO_SIDED|95.0|-16.52|10.65||The threshold for statistical significance was p=0.05|Mixed Models Analysis|||||10.65|-16.52|0.972
72442696|NCT02740231|144397948|SUPERIORITY||Adjusted mean difference|-7.17|STANDARD_DEVIATION|5.96||0.599|TWO_SIDED|95.0|-22.28|7.94||The threshold for statistical significance was p=0.05|Mixed Models Analysis|||||7.94|-22.28|0.599
72442697|NCT02740231|144397949|SUPERIORITY||Adjusted mean difference|-6.62|STANDARD_DEVIATION|4.3||0.126|TWO_SIDED|95.0||||The threshold for statistical significance was p=0.05|ANCOVA|||||||0.126
72442698|NCT02740231|144397950|SUPERIORITY||Adjusted mean difference|-8.88|STANDARD_DEVIATION|4.76||0.064|TWO_SIDED|95.0||||The threshold for statistical significance was p=0.05|ANCOVA|||||||0.064
72442699|NCT02740231|144397951|SUPERIORITY||Adjusted mean difference|-10.79|STANDARD_DEVIATION|4.35||0.014|TWO_SIDED|95.0|||||ANCOVA|||||||0.014
72442700|NCT02740231|144397952|SUPERIORITY||Adjusted mean difference|-10.57|STANDARD_DEVIATION|4.81||0.03|TWO_SIDED|95.0||||The threshold for statistical significance was p=0.05|ANCOVA|||||||0.030
72442701|NCT01000480|144397975|SUPERIORITY_OR_OTHER|||||||0.0645||95.0||||P-value for H0 which compared the investigational regimen to historical data.|maximum likelihood estimate|||Null hypothesis (H0): 1-year PFS ≤45% and the alternative hypothesis (H1): 1-year PFS ≥60%, at a 2-sided alpha level of 5%, assuming that PFS time followed an exponential distribution.||||0.0645
72442702|NCT00522951|144398073|NON_INFERIORITY_OR_EQUIVALENCE|non-inferiority margin = -1|Mean Difference (Final Values)|-0.58||||||95.0|-0.87|-0.29|||||Averaged blinded reader (primary analysis)|H01: μG1 - μPr ≤ -1||-0.29|-0.87|
72442703|NCT00522951|144398073|NON_INFERIORITY_OR_EQUIVALENCE|non-inferiority margin = -1|Mean Difference (Final Values)|0.06||||||95.0|-0.23|0.36|||||Averaged blinded reader (primary analysis)|H02: μG2 - μPr ≤ -1||0.36|-0.23|
72442704|NCT00522951|144398073|NON_INFERIORITY_OR_EQUIVALENCE|non-inferiority margin = -1|Mean Difference (Final Values)|-0.3||||||95.0|-0.5|-0.1|||||Investigator (secondary analysis)|H01: μG1 - μPr ≤ -1||-0.1|-0.5|
72442705|NCT00522951|144398073|NON_INFERIORITY_OR_EQUIVALENCE|non-inferiority margin = -1|Mean Difference (Final Values)|0.21||||||95.0|0.02|0.41|||||Investigator (secondary analysis)|H02: μG2 - μPr ≤ -1||0.41|0.02|
72442706|NCT00976495|144398091|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.07|STANDARD_ERROR_OF_MEAN|2.7177|||TWO_SIDED|95.0|-13.34|-2.49|||||ANCOVA was applied. Given that this was a pilot study designed for exploratory analysis, formal statistical hypothesis testing was not performed.|||-2.49|-13.34|
72442707|NCT00976495|144398091|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.62|STANDARD_ERROR_OF_MEAN|2.7068|||TWO_SIDED|95.0|-12.87|-2.06|||||ANCOVA was applied. Given that this was a pilot study designed for exploratory analysis, formal statistical hypothesis testing was not performed.|||-2.06|-12.87|
72442708|NCT00976495|144398092|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.4|STANDARD_ERROR_OF_MEAN|2.3613|||TWO_SIDED|95.0|-7.11|2.31|||||ANCOVA was applied. Given that this was a pilot study designed for exploratory analysis, formal statistical hypothesis testing was not performed.|||2.31|-7.11|
72442709|NCT00976495|144398092|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.26|STANDARD_ERROR_OF_MEAN|2.4112|||TWO_SIDED|95.0|-1.55|8.08|||||ANCOVA was applied. Given that this was a pilot study designed for exploratory analysis, formal statistical hypothesis testing was not performed.|||8.08|-1.55|
72442710|NCT00976495|144398093|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.38|STANDARD_ERROR_OF_MEAN|2.5072|||TWO_SIDED|95.0|-9.38|0.63|||||ANCOVA was applied. Given that this was a pilot study designed for exploratory analysis, formal statistical hypothesis testing was not performed.|||0.63|-9.38|
72442711|NCT00976495|144398093|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.91|STANDARD_ERROR_OF_MEAN|2.5474|||TWO_SIDED|95.0|-4.18|5.99|||||ANCOVA was applied. Given that this was a pilot study designed for exploratory analysis, formal statistical hypothesis testing was not performed.|||5.99|-4.18|
72442712|NCT00976495|144398094|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.16|STANDARD_ERROR_OF_MEAN|2.7812|||TWO_SIDED|95.0|-5.39|5.71|||||ANCOVA was applied. Given that this was a pilot study designed for exploratory analysis, formal statistical hypothesis testing was not performed.|||5.71|-5.39|
72442713|NCT00976495|144398094|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.31|STANDARD_ERROR_OF_MEAN|2.8135|||TWO_SIDED|95.0|1.7|12.93|||||ANCOVA was applied. Given that this was a pilot study designed for exploratory analysis, formal statistical hypothesis testing was not performed.|||12.93|1.70|
72442714|NCT02382744|144398141|SUPERIORITY_OR_OTHER||Difference between proportions (%)|10.0||||0.25|TWO_SIDED|95.0|-11.9|31.9||One-sided P-value based on the lack of plausibility that additional nerve stimulation would worsen sensory blockade rates.|Fisher Exact|||We sought to detect an increase in the rate of complete absence of sensation to pinprick 30 min following ultrasound-guided subsartorial saphenous nerve blockade to 90% from an assumed baseline of 64% as extrapolated from our previous study (cf. Head SJ et al. 2015) at β = 0.2. The required minimum sample size at α = 0.05 (one-sided) was 30 patients in each group. To be conservative, we aimed to enroll a total of 80 patients.||31.9|-11.9|0.25
72442715|NCT02382744|144398142|SUPERIORITY_OR_OTHER|||||||0.62||||||Two-sided P-value|Fisher Exact|||"This contingency-table type analysis (Fisher Exact test) compares the two groups, Ultrasound Guidance and Ultrasound Guidance and Nerve Stimulation, as far as the two categorical outcomes are concerned, block failure at 30 minutes post nerve block versus no block failure at 30 minutes post nerve block."||||0.62
72442716|NCT02382744|144398143|SUPERIORITY_OR_OTHER|||||||0.62|||||||Fisher Exact|||||||0.62
72442717|NCT02382744|144398144|SUPERIORITY_OR_OTHER|||||||0.26||||||Two-sided P-value|Fisher Exact|||"This contingency-table type analysis (Fisher Exact test) compares the two groups, Ultrasound Guidance and Ultrasound Guidance and Nerve Stimulation, as far as the two categorical outcomes are concerned, incomplete block at 30 minutes post nerve block versus no incomplete block at 30 minutes post nerve block."||||0.26
72442718|NCT02382744|144398145|SUPERIORITY_OR_OTHER||"Median survival ratio"|0.7||||0.12|TWO_SIDED|95.0|0.38|1.31|||Log Rank||"Numerator, group Ultrasound Guidance; denominator, group, Ultrasound Guidance + Nerve Stimulation"|"To assess speed of onset, sensation to pinprick in the distribution of the saphenous nerve was assessed for each patient every 5 min until complete sensory loss was noted, or until 30 min had elapsed. To compare the two groups in speed of onset on the basis of these data, we constructed Kaplan-Meyer survival curves for the times to onset of sensory blockade and compared the underlying time-to-event data with the log-rank test."||1.31|0.38|0.12
72442719|NCT02382744|144398149|SUPERIORITY_OR_OTHER||Difference between means (s)|107.0|||<|0.0001|TWO_SIDED|95.0|61.0|153.0|||t-test, 2 sided|||||153|61|<0.0001
72442720|NCT02382744|144398152|SUPERIORITY_OR_OTHER||"Median survival ratio"|0.58||||0.02|TWO_SIDED|95.0|0.37|0.93|||Log Rank||"Numerator, group Ultrasound Guidance; denominator, group, Ultrasound Guidance + Nerve Stimulation"|||0.93|0.37|0.02
72442721|NCT02382744|144398155|SUPERIORITY_OR_OTHER|||||||0.0057|||||||Fisher Exact|||"This contingency-table type analysis (Fisher Exact test) compares the two arms, Patients with response to nerve stimulation and Patients with lack response to nerve stimulation, as far as the two categorical outcomes are concerned, block failure at 30 minutes post nerve block versus no block failure at 30 minutes post nerve block."||||0.0057
72442722|NCT02975505|144398284|SUPERIORITY||beta|11.7|||<|0.05|TWO_SIDED|95.0|7.5|16.0|||Mixed Models Analysis|||||16|7.5|<0.05
72442723|NCT02975505|144398287|SUPERIORITY||beta|12.5||||0.05|TWO_SIDED|95.0|8.0|16.0|||Mixed Models Analysis|||||16|8|0.05
72442724|NCT03398148|144398289|SUPERIORITY||Adjusted Risk Difference|9.6||||0.0324|TWO_SIDED|90.0|2.2|17.0||P-value ≤ 0.05|Cochran-Mantel-Haenszel|Based on Cochran-Mantel-Haenszel (CMH) test stratified by baseline corticosteroid use (yes, no) and baseline adapted mayo score (≤ 7, \> 7).|Risk difference = (risankizumab - Placebo)|||17.0|2.2|0.0324
72442725|NCT03398148|144398289|SUPERIORITY||Adjusted Risk Difference|8.4||||0.046|TWO_SIDED|90.0|1.5|15.3||P-value ≤ 0.05|Cochran-Mantel-Haenszel|Based on Cochran-Mantel-Haenszel (CMH) test stratified by baseline corticosteroid use (yes, no) and baseline adapted mayo score (≤ 7, \> 7).|Risk difference = (risankizumab - Placebo)|||15.3|1.5|0.0460
72559751|NCT02906917|144649789|NON_INFERIORITY|Non-inferiority of IDegAsp OD versus IGlar OD + IAsp OD was considered confirmed if the 95% confidence interval for the mean treatment difference was entirely below 0.40%.|Treatment contrast|0.07|||<|0.0001|TWO_SIDED|95.0|-0.06|0.21||One-sided p-value for test of non-inferiority.|ANCOVA|Treatment, region, sex, previous insulin treatment and previous OAD treatment as categorical fixed effects and baseline response and age as covariate.||The response and change from baseline in response are analysed on 1000 complete, imputed data sets after multiple imputation for each treatment arm separately. A penalty of 0.4% is added to the week 26 values for all premature treatment discontinued subjects, and subject with missing HbA1c values at week 26 in the IDegAsp arm. Each of the imputed data sets are analysed through an analysis of covariance (ANCOVA).||0.21|-0.06|<0.0001
72559752|NCT02854800|144649844|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|||A separate t-test for each row was used to compare dropouts and completers.||||<0.05
72442726|NCT03398148|144398289|SUPERIORITY||Adjusted Risk Difference|8.7||||0.0397|TWO_SIDED|90.0|1.7|15.6||P-value ≤ 0.05.|Cochran-Mantel-Haenszel|Based on Cochran-Mantel-Haenszel (CMH) test stratified by baseline corticosteroid use (yes, no) and baseline adapted mayo score (≤ 7, \> 7).|Risk difference = (risankizumab - Placebo).|||15.6|1.7|0.0397
72442727|NCT03398148|144398290|SUPERIORITY||Adjusted Risk Difference|14.0|||<|0.0001|TWO_SIDED|95.0|10.0|18.0||Type I error rate control.|Cochran-Mantel-Haenszel|Stratified by Advanced Therapy-IR status (yes vs no), Baseline steroid use (yes vs. no) and Baseline Adapted Mayo Score (≤ 7, \> 7).||||18.0|10.0|<0.0001
72559753|NCT02854800|144649846|SUPERIORITY||||||<|0.05|||||||ANOVA|If the overall F test was significant, Tukey's Honestly Significant Difference post-hoc tests were performed.||One-way ANOVA was used to compare mean medication side effect ratings across the three arms/groups to determine whether one group had more severe symptoms that may have been related to study dropout.||||<0.05
72442728|NCT03398148|144398291|SUPERIORITY||Adjusted Risk Difference|18.7||||0.0028|TWO_SIDED|90.0|8.4|29.0||P-value ≤ 0.01|Cochran-Mantel-Haenszel|Stratified by baseline corticosteroid use (yes, no) and baseline adapted mayo score (\<= 7, \> 7).|Risk difference = (risankizumab - Placebo).|||29.0|8.4|0.0028
72442729|NCT03398148|144398291|SUPERIORITY||Adjusted Risk Difference|8.4||||0.0968|TWO_SIDED|90.0|0.1|16.7||P-value ≤ 0.1|Cochran-Mantel-Haenszel|Stratified by baseline corticosteroid use (yes, no) and baseline adapted mayo score (\<= 7, \> 7).|Risk difference = (risankizumab - Placebo).|||16.7|0.1|0.0968
72442730|NCT03398148|144398291|SUPERIORITY||Adjusted Risk Difference|10.5||||0.0512|TWO_SIDED|90.0|1.6|19.3||P-value ≤ 0.1|Cochran-Mantel-Haenszel|Stratified by baseline corticosteroid use (yes, no) and baseline adapted mayo score (\<= 7, \> 7).|Risk difference = (risankizumab - Placebo).|||19.3|1.6|0.0512
72442731|NCT03398148|144398293|SUPERIORITY||Adjusted Risk Difference|23.9||||0.0022|TWO_SIDED|90.0|11.0|36.7||P-value ≤ 0.01|Cochran-Mantel-Haenszel|Stratified by baseline corticosteroid use (yes, no) and baseline adapted mayo score (\<= 7, \> 7).|Risk difference = (risankizumab - Placebo).|||36.7|11.0|0.0022
72442732|NCT03398148|144398293|SUPERIORITY||Adjusted Risk Difference|28.4||||0.0002|TWO_SIDED|90.0|15.7|41.1||P-value ≤ 0.001|Cochran-Mantel-Haenszel|Stratified by baseline corticosteroid use (yes, no) and baseline adapted mayo score (\<= 7, \> 7).|Risk difference = (risankizumab - Placebo).|||41.1|15.7|0.0002
72442733|NCT03398148|144398293|SUPERIORITY||Adjusted Risk Difference|33.8|||<|0.0001|TWO_SIDED|90.0|20.7|46.9||P-value ≤ 0.001|Cochran-Mantel-Haenszel|Stratified by baseline corticosteroid use (yes, no) and baseline adapted mayo score (\<= 7, \> 7).|Risk difference = (risankizumab - Placebo).|||46.9|20.7|<0.0001
72442734|NCT03398148|144398294|SUPERIORITY||Adjusted Risk Difference|10.2||||0.1842|TWO_SIDED|90.0|-2.4|22.9|||Cochran-Mantel-Haenszel|Stratified by baseline corticosteroid use (yes, no) and baseline adapted mayo score (\<= 7, \> 7).|Risk difference = (risankizumab - Placebo).|||22.9|-2.4|0.1842
72442735|NCT03398148|144398294|SUPERIORITY||Adjusted Risk Difference|23.2||||0.0041|TWO_SIDED|90.0|9.9|36.4||P-value ≤ 0.01|Cochran-Mantel-Haenszel|Stratified by baseline corticosteroid use (yes, no) and baseline adapted mayo score (\<= 7, \> 7).|Risk difference = (risankizumab - Placebo).|||36.4|9.9|0.0041
72442736|NCT03398148|144398294|SUPERIORITY||Adjusted Risk Difference|13.1||||0.1117|TWO_SIDED|90.0|-0.4|26.6|||Cochran-Mantel-Haenszel|Stratified by baseline corticosteroid use (yes, no) and baseline adapted mayo score (\<= 7, \> 7).|Risk difference = (risankizumab - Placebo).|||26.6|-0.4|0.1117
72442737|NCT03398148|144398295|SUPERIORITY||Adjusted Risk Difference|8.3||||0.0192|TWO_SIDED|90.0|2.5|14.1||P-value ≤ 0.05|Cochran-Mantel-Haenszel|Stratified by baseline corticosteroid use (yes, no) and baseline adapted mayo score (\<= 7, \> 7).|Risk difference = (risankizumab - Placebo).|||14.1|2.5|0.0192
72442738|NCT03398148|144398295|SUPERIORITY||Adjusted Risk Difference|4.8||||0.0706|TWO_SIDED|90.0|0.4|9.1||P-value ≤ 0.1|Cochran-Mantel-Haenszel|Stratified by baseline corticosteroid use (yes, no) and baseline adapted mayo score (\<= 7, \> 7).|Risk difference = (risankizumab - Placebo).|||9.1|0.4|0.0706
72442739|NCT03398148|144398295|SUPERIORITY||Adjusted Risk Difference|8.7||||0.017|TWO_SIDED|90.0|2.7|14.6||P-value ≤ 0.05|Cochran-Mantel-Haenszel|Stratified by baseline corticosteroid use (yes, no) and baseline adapted mayo score (\<= 7, \> 7).|Risk difference = (risankizumab - Placebo).|||14.6|2.7|0.0170
72442740|NCT03398148|144398296|SUPERIORITY|||||||0.7737|||||||Chi-squared|P value for comparisons between treatment groups and placebo group using chi-square test or Fisher's exact test.||||||0.7737
72619116|NCT01550965|144769012|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|24.37|||<|0.001|TWO_SIDED|95.0|21.5|27.25|||Paired t-test, 2 sided|||Statistical analysis for Treatment Satisfaction Questionnaire for Medication (TSQM) Effectiveness.||27.25|21.50|<0.001
72442741|NCT03398148|144398296|SUPERIORITY|||||||0.7432|||||||Fisher Exact|P value for comparisons between treatment groups and placebo group using chi-square test or Fisher's exact test.||||||0.7432
72496481|NCT01360645|144522686|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.22||||0.0255|TWO_SIDED|95.0|-0.41|-0.03|||Cochran-Mantel-Haenszel|P-value and treatment difference (CI) are derived from CMH row mean score differ test controlling for study center.||Statistical analysis for Week 11||-0.03|-0.41|0.0255
72442742|NCT03398148|144398296|SUPERIORITY|||||||0.7172|||||||Fisher Exact|P value for comparisons between treatment groups and placebo group using chi-square test or Fisher's exact test.||||||0.7172
72496482|NCT01360645|144522686|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.36||||0.0005|TWO_SIDED|95.0|-0.57|-0.16|||Cochran-Mantel-Haenszel|P-value and treatment difference (CI) are derived from CMH row mean score differ test controlling for study center.||Statistical analysis for Week 12||-0.16|-0.57|0.0005
72559754|NCT02854800|144649849|SUPERIORITY||||||<|0.05|||||||ANOVA|If the overall F test was significant, Tukey's Honestly Significant Difference post-hoc tests were performed.||Mixed ANOVA was used with Study Week (1-12) as the within-subjects, repeated-measures factor and Group as the between-subjects factor. If the overall F test was significant, Tukey's Honestly Significant Difference post-hoc tests were performed.||||<0.05
72559755|NCT02854800|144649850|SUPERIORITY||||||<|0.05|||||||ANOVA|If the overall F test was significant, Tukey's Honestly Significant Difference post-hoc tests were performed.||One-way ANOVA was used for each side effect rating with Group as the between-subjects factor. If the overall F test was significant, Tukey's Honestly Significant Difference post-hoc tests were performed.||||<0.05
72559756|NCT02854800|144649851|SUPERIORITY||||||<|0.05|||||||ANOVA|If the overall F test was significant, Tukey's Honestly Significant Difference post-hoc tests were performed.||Data were analyzed via mixed ANOVA whereby Study Visit (1-4) was the repeated-measures factor and Group (weekly, biweekly, monthly) was the between-subjects factor. If the overall F test was significant, Tukey's Honestly Significant Difference post-hoc tests were performed.||||<0.05
72559757|NCT02854800|144649853|SUPERIORITY||||||<|0.05|||||||ANOVA|If the overall F test was significant, Tukey's Honestly Significant Difference post-hoc tests were performed.||Data were analyzed via mixed ANOVA whereby Study Visit (1-4) was the repeated-measures factor and Group (weekly, biweekly, monthly) was the between-subjects factor. If the overall F test was significant, Tukey's Honestly Significant Difference post-hoc tests were performed.||||<0.05
72559758|NCT02627963|144649868|SUPERIORITY||Hazard Ratio (HR)|0.73||||0.0165|TWO_SIDED|95.0|0.56|0.94||A one-sided, log-rank test stratified for IMDC risk category and prior therapy (two VEGFR TKIs vs. a checkpoint inhibitor plus a VEGFR TKI vs. a VEGFR TKI plus any other systemic agent) at a significance level of α = 0.025 was used.|Log Rank|||||0.94|0.56|0.0165
72442743|NCT03398148|144398297|SUPERIORITY||Adjusted Risk Difference|4.7||||0.0722|TWO_SIDED|90.0|0.4|9.0||P-value ≤ 0.1|Cochran-Mantel-Haenszel|Stratified by baseline corticosteroid use (yes, no) and baseline adapted mayo score (\<= 7, \> 7).|Risk difference = (risankizumab - Placebo).|||9.0|0.4|0.0722
72442744|NCT03398148|144398297|SUPERIORITY||Adjusted Risk Difference|3.1||||0.148|TWO_SIDED|90.0|-0.4|6.6|||Cochran-Mantel-Haenszel|Stratified by baseline corticosteroid use (yes, no) and baseline adapted mayo score (\<= 7, \> 7).|Risk difference = (risankizumab - Placebo).|||6.6|-0.4|0.1480
72442745|NCT03398148|144398297|SUPERIORITY||Adjusted Risk Difference|1.7||||0.3042|TWO_SIDED|90.0|-1.0|4.5|||Cochran-Mantel-Haenszel|Stratified by baseline corticosteroid use (yes, no) and baseline adapted mayo score (\<= 7, \> 7).|Risk difference = (risankizumab - Placebo).|||4.5|-1.0|0.3042
72442746|NCT03398148|144398298|SUPERIORITY||Least Squares (LS) Mean Difference|-6.4|STANDARD_ERROR_OF_MEAN|2.13||0.003|TWO_SIDED|90.0|-9.94|-2.89||P-value ≤ 0.01|Mixed-effect model repeated measurement|||||-2.89|-9.94|0.0030
72496483|NCT01360645|144522686|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.41||||0.0001|TWO_SIDED|95.0|-0.62|-0.2|||Cochran-Mantel-Haenszel|P-value and treatment difference (CI) are derived from CMH row mean score differ test controlling for study center.||Statistical analysis for Week 13||-0.20|-0.62|0.0001
72496484|NCT01360645|144522686|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.39||||0.0005|TWO_SIDED|95.0|-0.6|-0.17|||Cochran-Mantel-Haenszel|P-value and treatment difference (CI) are derived from CMH row mean score differ test controlling for study center.||Statistical analysis for Week 14||-0.17|-0.60|0.0005
72559759|NCT02627963|144649869|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.8174|TWO_SIDED|95.0|0.75|1.25|||Log Rank|||||1.25|0.75|0.8174
72559760|NCT01322633|144649880|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.68|||||TWO_SIDED|95.0|0.24|1.93||||||Analysis was based on hazard ratio using Cox proportional hazard regression method adjusted for sex, age, cumulative PPI dose, total years of PPI treatment, diabetes, hepatitis C, hepatitis B and year of index date.||1.93|0.24|
72559761|NCT01322633|144649881|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.95|||||TWO_SIDED|95.0|0.65|1.4||||||Analysis was based on hazard ratio using Cox proportional hazard regression method adjusted for sex, age, cumulative PPI dose, total years of PPI treatment, diabetes, hepatitis C, hepatitis B and year of index date.||1.40|0.65|
72559762|NCT01322633|144649882|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.06|||||TWO_SIDED|95.0|0.93|1.21||||||Analysis was based on hazard ratio using Cox proportional hazard regression method adjusted for sex, age, cumulative PPI dose, total years of PPI treatment, diabetes, hepatitis C, hepatitis B and year of index date.||1.21|0.93|
72559763|NCT05109104|144649883|OTHER|The t value from the '2-sided' Student-t distribution table corresponding to the upper 5% point with n-1 degrees of freedom was obtained and the labeled SPF value was determined as the largest whole number less than the following calculation: Labeled SPF = Mean SPF - (t\*SE).|Labeled SPF|25.0|||||TWO_SIDED|||||||||||||
72559764|NCT05109104|144649883|OTHER|The t value from the '2-sided' Student-t distribution table corresponding to the upper 5% point with n-1 degrees of freedom was obtained and the labeled SPF value was determined as the largest whole number less than the following calculation: Labeled SPF = Mean SPF - (t\*SE).|Labeled SPF|25.0|||||TWO_SIDED|||||||||||||
72442747|NCT03398148|144398298|SUPERIORITY||Least Squares (LS) Mean Difference|-8.2|STANDARD_ERROR_OF_MEAN|2.11||0.0001|TWO_SIDED|90.0|-11.67|-4.71||P-value ≤ 0.001|Mixed-effect model repeated measurement|||||-4.71|-11.67|0.0001
72442748|NCT03398148|144398298|SUPERIORITY||Least Squares (LS) Mean Difference|-7.7|STANDARD_ERROR_OF_MEAN|2.14||0.0004|TWO_SIDED|90.0|-11.27|-4.19||P-value ≤ 0.001|Mixed-effect model repeated measurement|||||-4.19|-11.27|0.0004
72442749|NCT03398148|144398299|SUPERIORITY||Least Squares (LS) Mean Difference|17.3|STANDARD_ERROR_OF_MEAN|6.47||0.0081|TWO_SIDED|90.0|6.61|28.0||P-value ≤ 0.01|Mixed-effect model repeated measurement|||||28|6.61|0.0081
72442750|NCT03398148|144398299|SUPERIORITY||Least Squares (LS) Mean Difference|20.3|STANDARD_ERROR_OF_MEAN|6.37||0.0017|TWO_SIDED|90.0|9.74|30.79||P-value ≤ 0.01|Mixed-effect model repeated measurement|||||30.79|9.74|0.0017
72442751|NCT03398148|144398299|SUPERIORITY||Least Squares (LS) Mean Difference|19.9|STANDARD_ERROR_OF_MEAN|6.49||0.0024|TWO_SIDED|90.0|9.22|30.67||P-value ≤ 0.01|Mixed-effect model repeated measurement|||||30.67|9.22|0.0024
72442752|NCT03398148|144398300|SUPERIORITY||Least Squares (LS) Mean Difference|1.208||||0.3315|TWO_SIDED|90.0|-0.8429|3.2596|||Mixed-effect model repeated measurement|||||3.2596|-0.8429|0.3315
72442753|NCT03398148|144398300|SUPERIORITY||LS Mean of Difference|2.447||||0.0451|TWO_SIDED|90.0|0.4415|4.4519||P-value ≤ 0.05|Mixed-effect model repeated measurement|||||4.4519|0.4415|0.0451
72559765|NCT05109104|144649883|OTHER|The t value from the '2-sided' Student-t distribution table corresponding to the upper 5% point with n-1 degrees of freedom was obtained and the labeled SPF value was determined as the largest whole number less than the following calculation: Labeled SPF = Mean SPF - (t\*SE).|Labeled SPF|27.0|||||TWO_SIDED|||||||||||||
72559766|NCT00323258|144649895|NON_INFERIORITY_OR_EQUIVALENCE|"Equivalence analysis. Null hypothesis: The will be no difference in proportion of participants adherent to triple therapy in the treatment arm compared to those who receive usual care."||||||0.5|||||||Chi-squared|||Sample size of 286 patients(143 patients per group).Based on an estimated absolute improvement in medication adherence of 15% in the intervention group (eg, 85% in the intervention group, 70% in the control group), a 2-sided test with α level of .05, a 15% dropout rate, and power of 0.80.||||.50
72559767|NCT00323258|144649896|NON_INFERIORITY_OR_EQUIVALENCE|"Equivalence analysis. Null hypothesis: The will be no difference in the proportion of participants who are \>/= 75% adherent to combined beta-blocker and statin therapy in the treatment arm compared to those who receive usual care."|||||=|0.11|||||||Chi-squared|||Sample Size calculated as 286 total or 143 patient per treatment group. Based on a baseline adherence rate of 70%, an estimated absolute improvement in medication adherence of 15.0% in the intervention group, we would require 122 patients per group assuming a 2-sided test with alpha-level of .05 and power of .80. To sustain a 15% dropout/ loss to follow-up rate, about 143 patients per group (286 patients total) would need to be consented.||||=0.11
72442754|NCT03398148|144398300|SUPERIORITY||LS Mean of Difference|2.392||||0.0543|TWO_SIDED|90.0|0.3498|4.4352||P-value ≤ 0.1|Mixed-effect model repeated measurement|||||4.4352|0.3498|0.0543
72442755|NCT03398148|144398301|SUPERIORITY||LS Mean of Difference|3.662||||0.0367|TWO_SIDED|90.0|0.7841|6.5402||P-value \<= 0.1|Mixed-effect model repeated measurement||P-value for test of difference between each Risankizumab dose group and placebo for mean change from baseline using the mixed-effect repeated measure model The unstructured covariance structure was used to estimate within subject errors.|||6.5402|0.7841|0.0367
72442756|NCT03398148|144398301|SUPERIORITY||LS Mean of Difference|4.19||||0.0151|TWO_SIDED|90.0|1.3656|7.0144||P-value \<= 0.05|Mixed-effect model repeated measurement||P-value for test of difference between each Risankizumab dose group and placebo for mean change from baseline using the mixed-effect repeated measure model The unstructured covariance structure was used to estimate within subject errors.|||7.0144|1.3656|0.0151
72442757|NCT03398148|144398301|SUPERIORITY||LS Mean of Difference|2.348||||0.1795|TWO_SIDED|90.0|-0.5322|5.2281|||Mixed-effect model repeated measurement||P-value for test of difference between each Risankizumab dose group and placebo for mean change from baseline using the mixed-effect repeated measure model The unstructured covariance structure was used to estimate within subject errors.|||5.2281|-0.5322|0.1795
72442758|NCT03398148|144398302|SUPERIORITY||Least Squares (LS) Mean Difference|3.9|STANDARD_ERROR_OF_MEAN|1.91||0.0422|TWO_SIDED|90.0|0.75|7.06||P-value ≤ 0.05|Mixed-effect model repeated measurement|||||7.06|0.75|0.0422
72442759|NCT03398148|144398302|SUPERIORITY||Least Squares (LS) Mean Difference|5.3|STANDARD_ERROR_OF_MEAN|1.87||0.0049|TWO_SIDED|90.0|2.23|8.42||P-value ≤ 0.01|Mixed-effect model repeated measurement|||||8.42|2.23|0.0049
72442760|NCT03398148|144398302|SUPERIORITY||Least Squares (LS) Mean Difference|4.6|STANDARD_ERROR_OF_MEAN|1.91||0.0156|TWO_SIDED|90.0|1.5|7.8||P-value ≤ 0.05|Mixed-effect model repeated measurement|||||7.80|1.50|0.0156
72442761|NCT03398148|144398303|SUPERIORITY|||||||1||||||P-Value for comparisons between treatment groups and placebo group using Fisher's exact test.|Fisher Exact|||Note: ITT1A includes all randomized subjects who received at least one dose of study drug during Induction Period 1 from Sub-Study 1.||||1
72442762|NCT03398148|144398304|SUPERIORITY||Adjusted Risk Difference|28.6|||<|0.0001|TWO_SIDED|95.0|22.3|34.8||Statistical significance is determined via the graphical multiple testing procedure controlling the overall type I error rate of primary and key secondary endpoints at the 0.05 level.|Cochran-Mantel-Haenszel||Between-group diff. and 95% CI calculated using Mantel-Haenszel common rate difference.|||34.8|22.3|<0.0001
72442763|NCT03398148|144398305|SUPERIORITY||Adjusted Risk Difference|24.3|||<|0.0001|TWO_SIDED|95.0|19.3|29.4||Statistical significance is determined via the graphical multiple testing procedure controlling the overall type I error rate of primary and key secondary endpoints at the 0.05 level.|Cochran-Mantel-Haenszel||Between-group diff. and 95% CI calculated using Mantel-Haenszel common rate difference. (Greenland and Robins (1985)).|||29.4|19.3|<0.0001
72442764|NCT03398148|144398306|SUPERIORITY||Adjusted Risk Difference|16.6|||<|0.0001|TWO_SIDED|95.0|12.3|21.0||Statistical significance is determined via the graphical multiple testing procedure controlling the overall type I error rate of primary and key secondary endpoints at the 0.05 level.|Cochran-Mantel-Haenszel||Between-group diff. and 95% CI calculated using Mantel-Haenszel common rate difference. (Greenland and Robins (1985)).|||21.0|12.3|<0.0001
72442765|NCT03398148|144398307|SUPERIORITY||Adjusted Risk Difference|7.2|||<|0.0001|TWO_SIDED|95.0|4.2|10.2||Statistical significance is determined via the graphical multiple testing procedure controlling the overall type I error rate of primary and key secondary endpoints at the 0.05 level.|Cochran-Mantel-Haenszel||Between-group diff. and 95% CI calculated using Mantel-Haenszel common rate difference. (Greenland and Robins (1985)).|||10.2|4.2|<0.0001
72442766|NCT03398148|144398308|SUPERIORITY||Adjusted Risk Difference|21.8|||<|0.0001|TWO_SIDED|95.0|15.6|28.1||Statistical significance is determined via the graphical multiple testing procedure controlling the overall type I error rate of primary and key secondary endpoints at the 0.05 level.|Cochran-Mantel-Haenszel||Between-group diff. and 95% CI calculated using Mantel-Haenszel common rate difference. (Greenland and Robins (1985)).|||28.1|15.6|<0.0001
72442767|NCT03398148|144398309|SUPERIORITY||Adjusted Risk Difference|16.3|||<|0.0001|TWO_SIDED|95.0|10.3|22.4||Statistical significance is determined via the graphical multiple testing procedure controlling the overall type I error rate of primary and key secondary endpoints at the 0.05 level.|Cochran-Mantel-Haenszel||Between-group diff. and 95% CI calculated using Mantel-Haenszel common rate difference. (Greenland and Robins (1985)).|||22.4|10.3|<0.0001
72619117|NCT01550965|144769012|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|18.95|||<|0.001|TWO_SIDED|95.0|15.42|22.48|||Paired t-test, 2 sided|||Statistical analysis for Treatment Satisfaction Questionnaire for Medication (TSQM) Side Effects.||22.48|15.42|<0.001
72619118|NCT01550965|144769012|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.2|||<|0.001|TWO_SIDED|95.0|3.89|8.5|||Paired t-test, 2 sided)|||Statistical analysis for Treatment Satisfaction Questionnaire for Medication (TSQM) Convenience.||8.50|3.89|<0.001
72496485|NCT01360645|144522687|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.25||||0.001|TWO_SIDED|95.0|-0.4|-0.1|||Cochran-Mantel-Haenszel|P-value and treatment difference (CI) are derived from CMH row mean score differ test controlling for study center.||Statistical analysis for Week 9||-0.10|-0.40|0.0010
72496486|NCT01360645|144522687|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.19||||0.029|TWO_SIDED|95.0|-0.37|-0.02|||Cochran-Mantel-Haenszel|P-value and treatment difference (CI) are derived from CMH row mean score differ test controlling for study center.||Statistical analysis for Week 10||-0.02|-0.37|0.0290
72496487|NCT01360645|144522687|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2||||0.0422|TWO_SIDED|95.0|-0.4|-0.01|||Cochran-Mantel-Haenszel|P-value and treatment difference (CI) are derived from CMH row mean score differ test controlling for study center.||Statistical analysis for Week 11||-0.01|-0.40|0.0422
72496488|NCT01360645|144522687|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.39||||0.0003|TWO_SIDED|95.0|-0.61|-0.18|||Cochran-Mantel-Haenszel|P-value and treatment difference (CI) are derived from CMH row mean score differ test controlling for study center.||Statistical analysis for Week 12||-0.18|-0.61|0.0003
72496489|NCT01360645|144522687|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.42||||0.0002|TWO_SIDED|95.0|-0.64|-0.2|||Cochran-Mantel-Haenszel|P-value and treatment difference (CI) are derived from CMH row mean score differ test controlling for study center.||Statistical analysis for Week 13||-0.20|-0.64|0.0002
72496490|NCT01360645|144522687|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.42||||0.0003|TWO_SIDED|95.0|-0.65|-0.19|||Cochran-Mantel-Haenszel|P-value and treatment difference (CI) are derived from CMH row mean score differ test controlling for study center.||Statistical analysis for Week 14||-0.19|-0.65|0.0003
72496491|NCT01360645|144522688|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.13||||0.0229|TWO_SIDED|95.0|-0.25|-0.02|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||Statistical analysis for Week 9||-0.02|-0.25|0.0229
72442768|NCT03398148|144398310|SUPERIORITY||Adjusted Risk Difference|9.3||||0.0021|TWO_SIDED|95.0|3.4|15.3||Statistical significance is determined via the graphical multiple testing procedure controlling the overall type I error rate of primary and key secondary endpoints at the 0.05 level.|Cochran-Mantel-Haenszel||Between-group diff. and 95% CI calculated using Mantel-Haenszel common rate difference. (Greenland and Robins (1985)).|||15.3|3.4|0.0021
72442769|NCT03398148|144398311|SUPERIORITY||Adjusted Risk Difference|5.6|||<|0.0001|TWO_SIDED|95.0|3.5|7.7||Statistical significance is determined via the graphical multiple testing procedure controlling the overall type I error rate of primary and key secondary endpoints at the 0.05 level.|Cochran-Mantel-Haenszel||Between-group diff. and 95% CI calculated using Mantel-Haenszel common rate difference. (Greenland and Robins (1985)).|||7.7|3.5|<0.0001
72388403|NCT01323959|144284641|SUPERIORITY_OR_OTHER||Percentage of subjects seroprotected|84.1|||||TWO_SIDED|95.0|73.3|91.8|||||The pre-specified lower limit (LL) of the 95% confidence interval (CI) for the percentage of seroprotected (Anti-D concentrations ≥ 0.1 IU/mL by ELISA or ≥ 0.01 IU/mL by VERO-cell when subjects with ELISA result \<0.1 IU/mL) subjects was above 80%.|The objective of the analysis was to demonstrate that a booster dose of Boostrix™ Polio vaccine, administered to adults 10 years after a dose of Boostrix™ Polio vaccine or co-administered Boostrix™ + Poliorix™ vaccines, elicited seroprotective antibody concentrations, one month after the booster dose, in at least 80% of the subjects against diphtheria.||91.8|73.3|
72388404|NCT02993757|144284662|OTHER||GMT ratio|0.982|||||TWO_SIDED|95.0|0.664|1.45||||||Antigen HPV-6||1.45|0.664|
72496492|NCT01360645|144522688|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.14||||0.0459|TWO_SIDED|95.0|-0.28|0.0|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||Statistical analysis for Week 10||-0.00|-0.28|0.0459
72496493|NCT01360645|144522688|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.21||||0.0097|TWO_SIDED|95.0|-0.37|-0.05|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||Statistical analysis for Week 11||-0.05|-0.37|0.0097
72496494|NCT01360645|144522688|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.25||||0.0038|TWO_SIDED|95.0|-0.42|-0.08|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||Statistical analysis for Week 12||-0.08|-0.42|0.0038
72496495|NCT01360645|144522688|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.36||||0.0001|TWO_SIDED|95.0|-0.54|-0.18|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||Statistical analysis for Week 13||-0.18|-0.54|0.0001
72496496|NCT01360645|144522688|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.34||||0.0004|TWO_SIDED|95.0|-0.52|-0.15|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||Statistical analysis for Week 14.||-0.15|-0.52|0.0004
72496497|NCT01360645|144522689|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.15||||0.0109|TWO_SIDED|95.0|-0.27|-0.04|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||Statistical analysis for Week 9||-0.04|-0.27|0.0109
72496498|NCT01360645|144522689|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.11||||0.1286|TWO_SIDED|95.0|-0.25|0.03|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||Statistical analysis for Week 10||0.03|-0.25|0.1286
72496499|NCT01360645|144522689|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.16||||0.0521|TWO_SIDED|95.0|-0.32|0.0|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||Statistical analysis for Week 11||0.00|-0.32|0.0521
72496500|NCT01360645|144522689|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.24||||0.0084|TWO_SIDED|95.0|-0.42|-0.06|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||Statistical analysis for Week 12||-0.06|-0.42|0.0084
72619119|NCT01550965|144769012|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|22.6|||<|0.001|TWO_SIDED|95.0|19.55|25.64|||Paired t-test, 2 sided|||Statistical analysis for Treatment Satisfaction Questionnaire for Medication (TSQM) Global Satisfaction.||25.64|19.55|<0.001
72496501|NCT01360645|144522689|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.35||||0.0003|TWO_SIDED|95.0|-0.54|-0.16|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||Statistical analysis for Week 13||-0.16|-0.54|0.0003
72559768|NCT00323258|144649897|NON_INFERIORITY_OR_EQUIVALENCE|"Equivalence analysis. Null hypothesis: The will be no difference in the proportion of participants who are \>/= 75% adherent to beta-blockers in the treatment arm compared to those who receive usual care."||||||0.03|||||||Chi-squared|||Sample Size calculated as 286 total or 143 patient per treatment group. Based on a baseline adherence rate of 70%, an estimated absolute improvement in medication adherence of 15.0% in the intervention group, we would require 122 patients per group assuming a 2-sided test with alpha-level of .05 and power of .80. To sustain a 15% dropout/ loss to follow-up rate, about 143 patients per group (286 patients total) would need to be consented.||||0.03
72559769|NCT00323258|144649898|NON_INFERIORITY_OR_EQUIVALENCE|"Equivalence analysis. Null hypothesis: The will be no difference in the proportion of participants who are \>/= 75% adherent to statins in the treatment arm compared to those who receive usual care."||||||0.34|||||||Chi-squared|||Sample Size calculated as 286 total or 143 patient per treatment group. Based on a baseline adherence rate of 70%, an estimated absolute improvement in medication adherence of 15.0% in the intervention group, we would require 122 patients per group assuming a 2-sided test with alpha-level of .05 and power of .80. To sustain a 15% dropout/ loss to follow-up rate, about 143 patients per group (286 patients total) would need to be consented.||||0.34
72559770|NCT01586039|144649901|SUPERIORITY|||||||0.73||||||Contrasting LED vs. CFL at 90 lux intensity|t-test, 2 sided|Paired t-test.||Contrasting LED vs. CFL at 90 lux intensity. Melatonin suppression is measured as the percentage of melatonin AUC relative to the AUC measured in dim light on the previous day. Higher values indicate more light-induced melatonin suppression.||||0.73
72559771|NCT01586039|144649901|SUPERIORITY|||||||0.001||||||Contrasting LED vs. CFL at 50 lux intensity|t-test, 2 sided|Paired t-test||Contrasting LED vs. CFL at 50 lux intensity||||0.001
72559772|NCT01586039|144649902|SUPERIORITY|||||||0.19|||||||t-test, 2 sided|Paired t-test||||||0.19
72559773|NCT01586039|144649904|SUPERIORITY|||||||0.17|||||||t-test, 2 sided|Paired t-test.||||||0.17
72559774|NCT01586039|144649904|SUPERIORITY|||||||1|||||||t-test, 2 sided|Paired test.||||||1.0
72559775|NCT01728636|144649951|SUPERIORITY|||||||0.05|||||||Wilcoxon (Mann-Whitney)|||||||.05
72559776|NCT03405363|144649966|OTHER|No formal hypotheses were tested.|Adjusted Incidence Rate Ratio|1.2|||||TWO_SIDED|95.0|0.98|1.47|||Poisson regression model|Including exposure, natural logarithm of person-years at risk as offset, propensity score quintiles, and LAMA use at the index date as a covariate.|Olodaterol compared to 'other LABA' as reference|||1.47|0.98|
72559777|NCT03405363|144649967|OTHER||Adjusted Incidence Rate Ratio|1.83|||||TWO_SIDED|95.0|0.9|3.74|||Poisson regression model|Including exposure, natural logarithm of person-years at risk as offset, propensity score quintiles, and LAMA use at the index date as a covariate.|Olodaterol compared to 'other LABA' as reference|No formal hypotheses were tested.||3.74|0.90|
72559778|NCT03405363|144649968|OTHER||Adjusted Incidence Rate Ratio|1.3|||||TWO_SIDED|95.0|0.71|2.36|||Poisson regression model|Including exposure, natural logarithm of person-years at risk as offset, propensity score quintiles, and LAMA use at the index date as a covariate.|Olodaterol compared to 'other LABA' as reference|No formal hypotheses were tested.||2.36|0.71|
72559779|NCT03405363|144649969|OTHER||Adjusted Incidence Rate Ratio|1.22|||||TWO_SIDED|95.0|0.79|1.87|||Poisson regression model|Including exposure, natural logarithm of person-years at risk as offset, propensity score quintiles, and LAMA use at the index date as a covariate.|Olodaterol compared to 'other LABA' as reference|No formal hypotheses were tested.||1.87|0.79|
72442770|NCT03398148|144398312|SUPERIORITY||Least Squares (LS) Mean Difference|4.5|||<|0.0001|TWO_SIDED|95.0|3.13|5.97||Statistical significance is determined via the graphical multiple testing procedure controlling the overall type I error rate of primary and key secondary endpoints at the 0.05 level.|ANCOVA||Between-group diff. and 95% CI calculated using ANCOVA/MMRM with RTB-MI for continuous endpoints.|||5.97|3.13|<0.0001
72559780|NCT03405363|144649970|OTHER||Adjusted Incidence Rate Ratio|1.0|||||TWO_SIDED|95.0|0.64|1.56|||Poisson regression model|Including exposure, natural logarithm of person-years at risk as offset, propensity score quintiles, and LAMA use at the index date as a covariate.|Olodaterol compared to 'other LABA' as reference|No formal hypotheses were tested.||1.56|0.64|
72559781|NCT03405363|144649971|OTHER|No formal hypotheses were tested.|Adjusted Incidence Rate Ratio|1.63|||||TWO_SIDED|95.0|1.44|1.84|||Poisson regression model|Including exposure, natural logarithm of person-years at risk as offset, propensity score quintiles, and LAMA use at the index date as a covariate.|Olodaterol compared to 'other LABA' as reference|Analysis was based on Propensity score-trimmed population of patients with Chronic Obstructive Pulmonary Disease (COPD) derived from the Danish Patient Registry.||1.84|1.44|
72559782|NCT03405363|144649971|OTHER|No formal hypotheses were tested.|Adjusted Incidence Rate Ratio|1.48|||||TWO_SIDED|95.0|1.23|1.78|||Poisson regression model||Olodaterol compared to 'other LABA' as reference|"Analysis based on post-hoc population 1.~Adjustments: propensity score decile, previous use of: LAMA, oxygen, inhaled glucocorticoid, respiratory medications, fixed-dose combinations of Short-Acting Beta2- Agonist and Short-Acting Muscarinic Antagonist and systemic antibacterials. COPD severity, number of: all-cause hospitalisations 365 and 180 days, COPD exacerbations 180 and 90 days, COPD hospitalisations 180 and 90 days, and COPD exacerbations 90 days before index date."||1.78|1.23|
72559783|NCT03405363|144649971|OTHER|No formal hypotheses were tested.|Adjusted Incidende Rate Ratio|1.26|||||TWO_SIDED|95.0|0.97|1.64|||Poisson regression model||Olodaterol compared to 'other LABA' as reference|Analysis based on post-hoc population 2. Adjustments: propensity score decile, previous use of: LAMA, oxygen, inhaled glucocorticoid, respiratory medications. COPD severity, number of all-cause hospitalisations 180 days, COPD exacerbations 180 days before cohort entry.||1.64|0.97|
72559784|NCT02533466|144649972|NON_INFERIORITY_OR_EQUIVALENCE|Equivalent analyses was executed using scale transformation or non-parametric methods.|Median Difference (Final Values)|-0.08||||0.2673|TWO_SIDED|95.0|-1.0|0.0||P-value was calculated from Wilcoxon Rank Sum test.|Wilcoxon Rank Sum test||"Median difference and 95% CI intervals were calculated from the Hodges Lehnmann estimate.~Difference was calculated as reference product minus test product."|||0.0|-1.0|0.2673
72442771|NCT03398148|144398313|SUPERIORITY||Least Squares (LS) Mean Difference|18.3|||<|0.0001|TWO_SIDED|95.0|13.38|23.25||Statistical significance is determined via the graphical multiple testing procedure controlling the overall type I error rate of primary and key secondary endpoints at the 0.05 level.|ANCOVA||Between-group diff. and 95% CI calculated using ANCOVA/MMRM with RTB-MI for continuous endpoints.|||23.25|13.38|<0.0001
72496502|NCT01360645|144522689|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.34||||0.0006|TWO_SIDED|95.0|-0.53|-0.15|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||Statistical analysis for Week 14||-0.15|-0.53|0.0006
72496503|NCT01360645|144522690|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.57||||0.0139|TWO_SIDED|95.0|-2.82|-0.32|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||Statistical analysis for Week 9||-0.32|-2.82|0.0139
72496504|NCT01360645|144522690|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.53||||0.0436|TWO_SIDED|95.0|-3.01|-0.04|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||Statistical analysis for Week 10||-0.04|-3.01|0.0436
72559785|NCT02533466|144649973|NON_INFERIORITY_OR_EQUIVALENCE|Equivalent analyses was executed using scale transformation or non-parametric methods|Median Difference (Final Values)|-0.92||||0.069|TWO_SIDED|95.0|-1.8|0.0||P-value was calculated from Wilcoxon Rank Sum test.|Wilcoxon Rank Sum Test||"Median difference and 95% CI intervals were calculated from the Hodges Lehnmann estimate.~Difference was calculated as reference product minus test product."|||0.0|-1.8|0.0690
72619120|NCT01550965|144769013|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.85|||<|0.001|TWO_SIDED|95.0|-5.42|-4.27|||Paired t-test, 2 sided|||Statistical analysis for overall UC-related outpatient utilization.||-4.27|-5.42|<0.001
72442772|NCT03398148|144398314|SUPERIORITY||Risk Difference (RD)|-4.8|||<|0.0001|TWO_SIDED|95.0|-7.3|-2.2||Statistical significance is determined via the graphical multiple testing procedure controlling the overall type I error rate of primary and key secondary endpoints at the 0.05 level.|Chi-squared||95% CI for treatment differences is based on normal approximation of the binomial proportions.|||-2.2|-7.3|<0.0001
72442773|NCT03398148|144398315|SUPERIORITY||Adjusted Risk Difference|24.2|||<|0.0001|TWO_SIDED|95.0|17.9|30.5||Statistical significance is determined via the graphical multiple testing procedure controlling the overall type I error rate of primary and key secondary endpoints at the 0.05 level.|Cochran-Mantel-Haenszel||Between-group diff. and 95% CI calculated using Mantel-Haenszel common rate difference. (Greenland and Robins (1985)).|||30.5|17.9|<0.0001
72442774|NCT03398148|144398316|SUPERIORITY||Adjusted Risk Difference|18.6|||<|0.0001|TWO_SIDED|95.0|12.4|24.8||Statistical significance is determined via the graphical multiple testing procedure controlling the overall type I error rate of primary and key secondary endpoints at the 0.05 level.|Cochran-Mantel-Haenszel||Between-group diff. and 95% CI calculated using Mantel-Haenszel common rate difference.|||24.8|12.4|<0.0001
72442775|NCT03398148|144398317|SUPERIORITY||Least Squares (LS) Mean Difference|-1.627|||<|0.0001|TWO_SIDED|95.0|-2.3846|-0.8689||Statistical significance is determined via the graphical multiple testing procedure controlling the overall type I error rate of primary and key secondary endpoints at the 0.05 level.|Mixed-Effect Model Repeated Measures||Between-group diff. and 95% CI calculated using ANCOVA/MMRM with RTB-MI for continuous endpoints.|||-0.8689|-2.3846|<0.0001
72442776|NCT03398148|144398318|SUPERIORITY||Least Squares (LS) Mean Difference|-0.981|||<|0.0001|TWO_SIDED|95.0|-1.3285|-0.6326||Statistical significance is determined via the graphical multiple testing procedure controlling the overall type I error rate of primary and key secondary endpoints at the 0.05 level.|Mixed-Effect Model Repeated Measures||Between-group diff. and 95% CI calculated using ANCOVA/MMRM with RTB-MI for continuous endpoints.|||-0.6326|-1.3285|<0.0001
72442777|NCT02791230|144398319|SUPERIORITY||Hazard Ratio (HR)|0.6202||||0.0001|TWO_SIDED|95.0|0.4865|0.7906|||Cox proportional hazards model||Hazard ratio from a Cox proportional hazards model with treatment, Transthyretin (TTR) genotype (variant and wild-type) and New York Heart Association (NYHA) baseline classification (NYHA Classes I and II combined and NYHA Class III) in the model.|||0.7906|0.4865|0.0001
72442778|NCT02791230|144398322|SUPERIORITY||Hazard ratio|0.6133||||0.0005|TWO_SIDED|95.0|0.4666|0.8062|||Cox Proportional Hazards model||Hazard ratio from a Cox proportional hazards model with treatment, TTR genotype (variant and wild-type) and NYHA baseline classification (NYHA Classes I and II combined and NYHA Class III) in the model.|||0.8062|0.4666|0.0005
72442779|NCT01259401|144398337|SUPERIORITY_OR_OTHER_LEGACY|||||||0.04|TWO_SIDED||||||ANCOVA|||||||.04
72442780|NCT01259401|144398338|SUPERIORITY_OR_OTHER_LEGACY|||||||0.061|TWO_SIDED||||||ANCOVA|||||||.061
72442781|NCT04201834|144398353|SUPERIORITY|||||||0.27|||||||Paired T-Test|||||||0.27
72442782|NCT04201834|144398354|SUPERIORITY|||||||0.92|||||||Paired T-Test|||||||0.92
72442783|NCT04201834|144398355|SUPERIORITY|||||||0.36|||||||Paired T-Test|||||||0.36
72442784|NCT04201834|144398356|SUPERIORITY|||||||0.62|||||||Paired T-Test|||||||0.62
72442785|NCT04201834|144398359|SUPERIORITY|||||||0.11|||||||Paired T-Test|||||||0.11
72442786|NCT04201834|144398360|SUPERIORITY|||||||0.02|||||||Paired T-Test|||||||0.02
72442787|NCT04201834|144398362|SUPERIORITY|||||||0.86|||||||Paired T-Test|||||||0.86
72442788|NCT04201834|144398363|SUPERIORITY|||||||0.27|||||||Paired T-Test|||||||0.27
72442789|NCT04201834|144398364|SUPERIORITY|||||||0.61|||||||Paired T-Test|||||||0.61
72442790|NCT04201834|144398365|SUPERIORITY|||||||0.37|||||||Paired T-Test|||||||0.37
72442791|NCT04201834|144398366|SUPERIORITY|||||||0.3|||||||Paired T-Test|||||||0.30
72442792|NCT04201834|144398367|SUPERIORITY|||||||0.82|||||||Paired t-test|||||||0.82
72442793|NCT03661359|144398371|OTHER|||||||0.727||||||correlation is significant at the 0.05 level (2 tailed)|pearson correlation|||Correlation between patient satisfaction and domains at risk.||||.727
72442794|NCT03661359|144398373|OTHER|||||||0.002||||||correlation is significant at the 0.01 level 2 tailed|pearson correlation|||correlation between physical quality of life and mental of life||||0.002
72442795|NCT03661359|144398375|OTHER|||||||0.727|TWO_SIDED|0.05|||||pearson correlation|||||||0.727
72442796|NCT04310735|144398376|OTHER|Independent-samples t-tests were conducted to compare the mean contrast of parameter estimate (COPE) values, derived from the contrast of smoking-related versus neutral cue activation, between the Expect-Yes and Expect-No groups in the ventromedial prefrontal cortex region of interest.||||||0.13||||||Statistical significance was defined a priori as p\<0.05.|t-test, 2 sided|||The null hypothesis was that there is no difference in the population means of the two groups.||||0.13
72496505|NCT01360645|144522690|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.1||||0.1903|TWO_SIDED|95.0|-2.75|0.55|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||Statistical analysis for Week 11||0.55|-2.75|0.1903
72559786|NCT02533466|144649974|NON_INFERIORITY_OR_EQUIVALENCE|Equivalent analyses was executed using scale transformation or non-parametric methods|Median Difference (Final Values)|-1.5||||0.068|TWO_SIDED|95.0|-2.7|0.0||P-value was calculated from Wilcoxon Rank Sum test.|Wilcoxon Rank Sum test||"Median difference and 95% CI intervals were calculated from the Hodges Lehnmann estimate.~Difference was calculated as reference product minus test product."|||0.0|-2.7|0.0680
72559787|NCT02533466|144649975|NON_INFERIORITY_OR_EQUIVALENCE|Equivalent analyses was executed using scale transformation or non-parametric methods|Median Difference (Final Values)|-1.83||||0.0654|TWO_SIDED|95.0|-3.0|0.0||P-value is calculated from Wilcoxon Rank Sum test.|Wilcoxon Rank Sum test.||"Median difference and 95% CI intervals were calculated from the Hodges Lehnmann estimate.~Difference was calculated as reference product minus test product"|||0.0|-3.0|0.0654
72559788|NCT02533466|144649976|NON_INFERIORITY_OR_EQUIVALENCE|Equivalent analyses was executed using scale transformation or non-parametric methods.|Mean Difference (Final Values)|-1.4||||0.6061|TWO_SIDED|95.0|-6.8|4.1||P value obtained from the ANCOVA analysis|ANCOVA||Difference and 95 % CI obtained from the ANCOVA analysis. Difference was calculated as reference product minus test product.|||4.1|-6.8|0.6061
72559789|NCT02533466|144649977|NON_INFERIORITY_OR_EQUIVALENCE|Equivalent analyses was executed using scale transformation or non-parametric methods.|Mean Difference (Final Values)|-2.3||||0.408|TWO_SIDED|95.0|-7.9|3.3||P value obtained from the ANCOVA analysis.|ANCOVA||Difference and 95 % CI obtained from the ANCOVA analysis. Difference was calculated as reference product minus test product|||3.3|-7.9|0.4080
72619121|NCT01550965|144769013|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.01||||0.83|TWO_SIDED|95.0|-0.11|0.09|||Paired t-test, 2 sided|||Statistical analysis for overall UC-related outpatient utilization during emergency department visits.||0.09|-0.11|0.830
72388405|NCT02993757|144284662|OTHER||GMT ratio|0.804|||||TWO_SIDED|95.0|0.626|1.03||||||Antigen HPV-11||1.03|0.626|
72388406|NCT02993757|144284662|OTHER||GMT ratio|0.815|||||TWO_SIDED|95.0|0.608|1.09||||||Antigen HPV-16||1.09|0.608|
72388407|NCT02993757|144284662|OTHER||GMT ratio|0.795|||||TWO_SIDED|95.0|0.603|1.05||||||Antigen HPV-18||1.05|0.603|
72388408|NCT02993757|144284663|OTHER||GMT ratio|0.987|||||TWO_SIDED|95.0|0.574|1.7||||||Serotype 1||1.70|0.574|
72388409|NCT02993757|144284663|OTHER||GMT ratio|0.783|||||TWO_SIDED|95.0|0.5|1.22||||||Serotype 2||1.22|0.500|
72388410|NCT02993757|144284663|OTHER||GMT ratio|0.836|||||TWO_SIDED|95.0|0.568|1.23||||||Serotype 3||1.23|0.568|
72388411|NCT02993757|144284663|OTHER||GMT ratio|1.07|||||TWO_SIDED|95.0|0.813|1.4||||||Serotype 4||1.40|0.813|
72388412|NCT02762578|144284676|NON_INFERIORITY|"Stepwise hierarchical testing procedure was applied for confirmatory endpoints:~Step 1: Primary analysis: Non-inferiority with respect to change from baseline in HbA1c (%) to week 26 for IDegAsp vs. BIAsp 30.~Non-inferiority was considered confirmed if the upper bound of the two-sided 95% confidence interval was below or equal to 0.4%."|Treatment contrast|-0.08||||0.243|TWO_SIDED|95.0|-0.2|0.05||Two-sided p-value for testing difference|ANCOVA|||Change from baseline in HbA1c after 26 weeks of treatments was analysed using an ANCOVA method with treatment, anti-diabetic therapy at screening and sex as fixed factors, and age and baseline HbA1c as covariates.||0.05|-0.20|0.2430
72388413|NCT02762578|144284676|SUPERIORITY|"If non-inferiority was confirmed, the superiority of the IDegAsp group over the BIAsp 30 group was to be investigated.~Superiority was considered confirmed if the upper bound of the two-sided 95% confidence interval, which was calculated using the FAS, was below 0%."|Treatment contrast|-0.08||||0.243|TWO_SIDED|95.0|-0.2|0.05||Two-sided p-value for testing difference|ANCOVA|||Change from baseline in HbA1c after 26 weeks of treatments was analysed using an ANCOVA method with treatment, anti-diabetic therapy at screening and sex as fixed factors, and age and baseline HbA1c as covariates.||0.05|-0.20|0.2430
72395158|NCT03978520|144296910|SUPERIORITY||Response Rate Difference|16.9|||=|0.028|TWO_SIDED|95.0|1.8|31.9|||Cochran-Mantel-Haenszel|||"Elsubrutinib placebo/upadacitinib 30 mg vs elsubrutinib placebo/upadacitinib placebo~The difference between the groups was assessed using the Cochran-Mantel-Haenszel (CMH) test, stratified by baseline corticosteroid dose above 10 mg prednisone-equivalent (≤10 mg or \> 10 mg), screening SLEDAI-2K (\< 10 or ≥10), baseline interferon score (high or low or NA), baseline immunosuppressant (azathioprine, tacrolimus, cyclosporine, methotrexate \[MTX\], mycophenolate) (yes or no)."||31.9|1.8|=0.028
72395159|NCT03978520|144296910|SUPERIORITY||Response Rate Difference|-4.7|||=|0.566|TWO_SIDED|95.0|-20.8|11.4|||Cochran-Mantel-Haenszel|||"ABBV-599 High Dose (Elsubrutinib 60 mg/upadacitinib 30 mg) vs elsubrutinib placebo/upadacitinib 30 mg~The difference between the groups was assessed using the Cochran-Mantel-Haenszel (CMH) test, stratified by baseline corticosteroid dose above 10 mg prednisone-equivalent (≤10 mg or \> 10 mg), screening SLEDAI-2K (\< 10 or ≥10), baseline interferon score (high or low or NA), baseline immunosuppressant (azathioprine, tacrolimus, cyclosporine, methotrexate \[MTX\], mycophenolate) (yes or no)."||11.4|-20.8|=0.566
72395160|NCT03978520|144296911|SUPERIORITY||Response Rate Difference|18.3|||=|0.013|TWO_SIDED|95.0|3.9|32.6|||Cochran-Mantel-Haenszel|||"ABBV-599 High Dose (Elsubrutinib 60 mg/upadacitinib 30 mg) vs elsubrutinib placebo/upadacitinib placebo~The difference between the groups was assessed using the Cochran-Mantel-Haenszel (CMH) test, stratified by baseline corticosteroid dose above 10 mg prednisone-equivalent (≤10 mg or \> 10 mg), screening SLEDAI-2K (\< 10 or ≥10), baseline interferon score (high or low or NA), baseline immunosuppressant (azathioprine, tacrolimus, cyclosporine, methotrexate \[MTX\], mycophenolate) (yes or no)."||32.6|3.9|=0.013
72395161|NCT03978520|144296911|SUPERIORITY||Response Rate Difference|18.1|||=|0.018|TWO_SIDED|95.0|3.0|33.2|||Cochran-Mantel-Haenszel|||"Elsubrutinib placebo/upadacitinib 30 mg vs elsubrutinib placebo/upadacitinib placebo~The difference between the groups was assessed using the Cochran-Mantel-Haenszel (CMH) test, stratified by baseline corticosteroid dose above 10 mg prednisone-equivalent (≤10 mg or \> 10 mg), screening SLEDAI-2K (\< 10 or ≥10), baseline interferon score (high or low or NA), baseline immunosuppressant (azathioprine, tacrolimus, cyclosporine, methotrexate \[MTX\], mycophenolate) (yes or no)."||33.2|3.0|=0.018
72395162|NCT03978520|144296911|SUPERIORITY||Response Rate Difference|-1.2|||=|0.882|TWO_SIDED|95.0|-17.6|15.2|||Cochran-Mantel-Haenszel|||"ABBV-599 High Dose (Elsubrutinib 60 mg/upadacitinib 30 mg) vs elsubrutinib placebo/upadacitinib 30 mg~The difference between the groups was assessed using the Cochran-Mantel-Haenszel (CMH) test, stratified by baseline corticosteroid dose above 10 mg prednisone-equivalent (≤10 mg or \> 10 mg), screening SLEDAI-2K (\< 10 or ≥10), baseline interferon score (high or low or NA), baseline immunosuppressant (azathioprine, tacrolimus, cyclosporine, methotrexate \[MTX\], mycophenolate) (yes or no)."||15.2|-17.6|=0.882
72559790|NCT02533466|144649978|NON_INFERIORITY_OR_EQUIVALENCE|Equivalent analyses was executed using scale transformation or non-parametric methods.|Median Difference (Final Values)|0.21||||0.4611|TWO_SIDED|95.0|-0.4|0.8||P value obtained from the ANCOVA analysis.|ANCOVA||Difference and 95 % CI obtained from the ANCOVA analysis. Difference was calculated as reference product minus test product.|||0.8|-0.4|0.4611
72559791|NCT02533466|144649979|NON_INFERIORITY_OR_EQUIVALENCE|Equivalent analyses was executed using scale transformation or non-parametric methods.|Mean Difference (Net)|0.09||||0.3939|TWO_SIDED|95.0|-0.1|0.3||P value obtained from the ANCOVA analysis.|ANCOVA|||||0.3|-0.1|0.3939
72559792|NCT02533466|144649980|NON_INFERIORITY_OR_EQUIVALENCE|Equivalent analyses was executed using scale transformation or non-parametric methods.|Mean Difference (Final Values)|0.34||||0.7829|TWO_SIDED|95.0|-2.2|2.8||P value obtained from the ANCOVA analysis.|ANCOVA||Difference and 95 % CI obtained from the ANCOVA analysis. Difference was calculated as reference product minus test product.|||2.8|-2.2|0.7829
72388414|NCT02762578|144284677|SUPERIORITY|"Stepwise hierarchical testing procedure was applied for confirmatory endpoints:~Step 2: Superiority with respect to change from baseline in FPG to week 26 for IDegAsp vs. BIAsp 30 (Provided that non-inferiority was confirmed for the primary endpoint)~Superiority was considered confirmed if the 95% CI for the treatment difference (IDegAsp group-BIAsp 30 group) was entirely below zero."|Treatment Contrast|-1.42|||<|0.0001|TWO_SIDED|95.0|-1.74|-1.1||Two-sided p-value for testing difference|ANCOVA|||Change from baseline in FPG after 26 weeks of treatment was analysed using an ANCOVA method with treatment, anti-diabetic therapy at screening and sex as fixed factors, and age and baseline FPG as covariates.||-1.10|-1.74|<0.0001
72388415|NCT02762578|144284678|SUPERIORITY|"Stepwise hierarchical testing procedure was applied for confirmatory endpoints:~Step 3: Superiority with respect to nocturnal confirmed hypoglycaemic episodes for IDegAsp vs. BIAsp 30 (provided that superiority with respect to change from baseline in FPG to week 26 was confirmed for IDegAsp vs. BIAsp 30).~Superiority was considered confirmed if the 95% CI for the rate ratio (IDegAsp group/BIAsp 30 group) was entirely below one."|Treatment Ratio|0.53||||0.0112|TWO_SIDED|95.0|0.33|0.87|||Negative binomial regression model|||The number of events was analysed using a Negative Binomial Model with a log-link function and the logarithm of the exposure time (100 years) for which a hypoglycaemic episode is considered treatment emergent as offset. The model included treatment, anti-diabetic therapy at screening and sex as fixed factors, and age as covariate.||0.87|0.33|0.0112
72388416|NCT02762578|144284679|SUPERIORITY|"Stepwise hierarchical testing procedure was applied for confirmatory endpoints:~Step 4: Superiority with respect to confirmed hypoglycaemic episodes for IDegAsp vs. BIAsp 30 (provided that superiority with respect to nocturnal confirmed hypoglycaemic episodes for IDegAsp vs. BIAsp 30 was confirmed).~Superiority was considered confirmed if the 95% CI for the rate ratio (IDegAsp group/BIAsp 30 group) was entirely below one."|Treatment Ratio|0.57||||0.0002|TWO_SIDED|95.0|0.42|0.77|||Negative binomial regression model|||The number of events was analysed using a Negative Binomial Model with a log-link function and the logarithm of the exposure time (100 years) for which a hypoglycaemic episode is considered treatment emergent as offset. The model included treatment, anti-diabetic therapy at screening and sex as fixed factors, and age as covariate||0.77|0.42|0.0002
72388417|NCT02762578|144284680|SUPERIORITY|"Stepwise hierarchical testing procedure was applied for confirmatory endpoints:~Step 5: Superiority with respect to change from baseline in body weight for IDegAsp vs. BIAsp 30 (provided that Superiority with respect to confirmed hypoglycaemic episodes for IDegAsp vs. BIAsp 30 was confirmed).~Superiority was considered confirmed if the 95% CI for the treatment difference (IDegAsp group-BIAsp 30 group) was entirely below zero"|Treatment contrast|0.61||||0.0092|TWO_SIDED|95.0|0.15|1.08|||ANCOVA|Two-sided p-value for testing difference||The response and change from baseline in response after 26 weeks were analysed using an ANCOVA model with treatment, anti-diabetic therapy at screening and sex as fixed factors, age and baseline response as covariate.||1.08|0.15|0.0092
72388418|NCT02762578|144284681|SUPERIORITY|"Stepwise hierarchical testing procedure was applied for confirmatory endpoints:~Step 6: Superiority with respect to subjects achieving HbA1c \< 7% at end of trial without confirmed hypoglycaemia for IDegAsp vs. BIAsp 30 (provided that superiority with respect to change from baseline in body weight was confirmed).~Superiority was considered confirmed if the 95% CI for the odds ratio (IDegAsp group/BIAsp 30 group) was entirely above one."|Treatment Ratio|2.22||||0.0002|TWO_SIDED|95.0|1.47|3.35||Two-sided p-value for testing difference|Regression, Logistic|||The endpoint was analysed in a logistic regression model using a logit link, including treatment, sex and anti-diabetic treatment at screening as fixed effects, and age and HbA1c as covariates.||3.35|1.47|0.0002
72388419|NCT01090492|144284755|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.11||||0.6513|TWO_SIDED|80.0|-0.21|0.44|||ANCOVA|||PRP: Adjusted mean difference analysis was based on Analysis of Covariance (ANCOVA) model with sequence, period and treatment as fixed effects and participant within sequence as a random effect, utilizing the baseline scores as covariate.||0.44|-0.21|0.6513
72388420|NCT01090492|144284755|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.69||||0.0057|TWO_SIDED|80.0|-0.99|-0.38|||ANCOVA|||PRP: Adjusted mean difference analysis was based on ANCOVA model with sequence, period and treatment as fixed effects and participant within sequence as a random effect, utilizing the baseline scores as covariate.||-0.38|-0.99|0.0057
72388421|NCT01090492|144284755|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.44||||0.1157|TWO_SIDED|80.0|-0.8|-0.08|||ANCOVA|||SRP: Adjusted mean difference analysis was based on ANCOVA model with sequence, period and treatment as fixed effects and participant within sequence as a random effect, utilizing the baseline scores as covariate.||-0.08|-0.80|0.1157
72388422|NCT01090492|144284755|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.15||||0.6286|TWO_SIDED|80.0|-0.56|0.25|||ANCOVA|||SRP: Adjusted mean difference analysis was based on ANCOVA model with sequence, period and treatment as fixed effects and participant within sequence as a random effect, utilizing the baseline scores as covariate.||0.25|-0.56|0.6286
72559793|NCT02533466|144649981|NON_INFERIORITY_OR_EQUIVALENCE|Equivalent analyses was executed using scale transformation or non-parametric methods|Mean Difference (Final Values)|-0.08||||0.9121|TWO_SIDED|95.0|-1.6|1.4||P value obtained from the ANCOVA analysis.|ANCOVA||Difference and 95 % CI obtained from the ANCOVA analysis. Difference was calculated as reference product minus test product.|||1.4|-1.6|0.9121
72559794|NCT01874535|144649993|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.009|||<|0.05|TWO_SIDED||||||Chi-squared|||||||<0.05
72619122|NCT01550965|144769013|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.92|||<|0.001|TWO_SIDED|95.0|-1.18|-0.66|||Paired t-test, 2 sided|||Statistical analysis for overall UC-related outpatient utilization during primary care doctor visits.||-0.66|-1.18|<0.001
72496506|NCT01360645|144522690|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.47||||0.0951|TWO_SIDED|95.0|-3.21|0.26|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||Statistical analysis for Week 12||0.26|-3.21|0.0951
72496507|NCT01360645|144522690|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.75||||0.0626|TWO_SIDED|95.0|-3.59|0.09|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||Statistical analysis for Week 13||0.09|-3.59|0.0626
72496508|NCT01360645|144522690|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.96||||0.0435|TWO_SIDED|95.0|-3.87|-0.06|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||Statistical analysis for Week 14||-0.06|-3.87|0.0435
72388423|NCT01090492|144284756|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.12||||0.9504|TWO_SIDED|80.0|-2.43|2.68|||ANCOVA|||At Week 4 - PRP: Adjusted mean difference analysis was based on ANCOVA model with sequence, period and treatment as fixed effects and participant within sequence as a random effect, utilizing the baseline scores as covariate.||2.68|-2.43|0.9504
72559795|NCT03790137|144649995|OTHER|The frequency of HWE for each patient was reported as episodes/day, as determined by dividing the total number of seizures experienced over a given time period by the number of days for which seizures were recorded. Paired t-tests were performed to compare each patient's baseline seizure frequency to their seizure frequency in the last month of treatment. Change in seizure frequency is reported as percent change from baseline. An alpha of 0.05 was used for statistical significance.|||||<|0.001|||||||t-test, 1 sided|||||||<0.001
72559796|NCT01929681|144650012|SUPERIORITY||||||<|0.049|||||||Regression, Linear|||||||<0.049
72559797|NCT01929681|144650013|SUPERIORITY||||||<|0.182|||||||Regression, Linear|||||||<0.182
72388424|NCT01090492|144284756|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.35||||0.4651|TWO_SIDED|80.0|-3.74|1.03|||ANCOVA|||At Week 4 - PRP: Adjusted mean difference analysis was based on ANCOVA model with sequence, period and treatment as fixed effects and participant within sequence as a random effect, utilizing the baseline scores as covariate.||1.03|-3.74|0.4651
72388425|NCT01090492|144284756|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.59||||0.7423|TWO_SIDED|80.0|-2.92|1.73|||ANCOVA|||At Week 4 - SRP: Adjusted mean difference analysis was based on ANCOVA model with sequence, period and treatment as fixed effects and participant within sequence as a random effect, utilizing the baseline scores as covariate.||1.73|-2.92|0.7423
72388426|NCT01090492|144284756|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.91||||0.3524|TWO_SIDED|80.0|-4.55|0.73|||ANCOVA|||At Week 4 - SRP: Adjusted mean difference analysis was based on ANCOVA model with sequence, period and treatment as fixed effects and participant within sequence as a random effect, utilizing the baseline scores as covariate.||0.73|-4.55|0.3524
72388427|NCT01090492|144284757|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|1.21||||0.79|TWO_SIDED|80.0|-4.61|7.03|||ANCOVA|||PRP: Adjusted mean difference analysis was based on ANCOVA model with sequence, period and treatment as fixed effects and participant within sequence as a random effect, utilizing the baseline scores as covariate.||7.03|-4.61|0.7900
72388428|NCT01090492|144284757|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-6.17||||0.1463|TWO_SIDED|80.0|-11.61|-0.73|||ANCOVA|||PRP: Adjusted mean difference analysis was based on ANCOVA model with sequence, period and treatment as fixed effects and participant within sequence as a random effect, utilizing the baseline scores as covariate.||-0.73|-11.61|0.1463
72388429|NCT01090492|144284757|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-2.37||||0.1446|TWO_SIDED|80.0|-4.44|-0.29|||ANCOVA|||SRP: Adjusted mean difference analysis was based on ANCOVA model with sequence, period and treatment as fixed effects and participant within sequence as a random effect, utilizing the baseline scores as covariate.||-0.29|-4.44|0.1446
72388430|NCT01090492|144284757|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.09||||0.5497|TWO_SIDED|80.0|-3.45|1.26|||ANCOVA|||SRP: Adjusted mean difference analysis was based on ANCOVA model with sequence, period and treatment as fixed effects and participant within sequence as a random effect, utilizing the baseline scores as covariate.||1.26|-3.45|0.5497
72388431|NCT01090492|144284758|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.15||||0.5909|TWO_SIDED|80.0|-0.21|0.52|||ANCOVA|||Week 4 (PRP): Adjusted mean difference analysis was based on ANCOVA model with sequence, period and treatment as fixed effects and participant within sequence as a random effect, utilizing the baseline scores as covariate.||0.52|-0.21|0.5909
72496509|NCT01360645|144522691|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.71||||0.0069|TWO_SIDED|95.0|-2.95|-0.47|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||Statistical analysis for Week 9||-0.47|-2.95|0.0069
72496510|NCT01360645|144522691|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.16||||0.1322|TWO_SIDED|95.0|-2.68|0.35|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||Statistical analysis for Week 10||0.35|-2.68|0.1322
72496511|NCT01360645|144522691|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.72||||0.4055|TWO_SIDED|95.0|-2.41|0.98|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||Statistical analysis for Week 11||0.98|-2.41|0.4055
72496512|NCT01360645|144522691|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.26||||0.1715|TWO_SIDED|95.0|-3.08|0.55|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||Statistical analysis for Week 12||0.55|-3.08|0.1715
72496513|NCT01360645|144522691|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.42||||0.1424|TWO_SIDED|95.0|-3.33|0.48|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||Statistical analysis for Week 13||0.48|-3.33|0.1424
72559798|NCT01929681|144650014|SUPERIORITY||||||<|0.449|||||||Regression, Linear|Mixed effects analysis||||||<0.449
72559799|NCT01929681|144650015|SUPERIORITY||||||<|0.444|||||||Regression, Linear|Mixed effects analysis||||||<0.444
72559800|NCT01929681|144650016|SUPERIORITY||||||<|0.182|||||||Regression, Linear|Mixed effects analysis||||||<0.182
72559801|NCT01073631|144650019|SUPERIORITY_OR_OTHER||Efficacy rate (percent)|78.9|||||TWO_SIDED|95.0|75.07|82.73|||Normal approximation to binomial||Confidence Interval (CI) by normal approximation to binomial.|Efficacy Rate (treatment effective) = Percentage of evaluable participants with clinical response of cure or improvement||82.73|75.07|
72559802|NCT01971554|144650070|SUPERIORITY_OR_OTHER||Difference in the least squares means|30.8|||||TWO_SIDED|90.0|11.3|50.3|||||A constrained longitudinal data analysis (cLDA) model was used to fit to the FPG data from the MK-8666 dose groups and placebo. Time was treated as a categorical variable so that no restriction was imposed on the trajectory of the means over time.|||50.3|11.3|
72388432|NCT01090492|144284758|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.77||||0.0053|TWO_SIDED|80.0|-1.12|-0.43|||ANCOVA|||Week 4 (PRP): Adjusted mean difference analysis was based on ANCOVA model with sequence, period and treatment as fixed effects and participant within sequence as a random effect, utilizing the baseline scores as covariate.||-0.43|-1.12|0.0053
72388433|NCT01090492|144284758|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.28||||0.3462|TWO_SIDED|80.0|-0.67|0.1|||ANCOVA|||Week 4 (SRP): Adjusted mean difference analysis was based on ANCOVA model with sequence, period and treatment as fixed effects and participant within sequence as a random effect, utilizing the baseline scores as covariate.||0.10|-0.67|0.3462
72388434|NCT01090492|144284758|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.44||||0.194|TWO_SIDED|80.0|-0.88|-0.01|||ANCOVA|||Week 4 (SRP): Adjusted mean difference analysis was based on ANCOVA model with sequence, period and treatment as fixed effects and participant within sequence as a random effect, utilizing the baseline scores as covariate.||-0.01|-0.88|0.1940
72388435|NCT01611155|144284768|SUPERIORITY|||||||0.87|||||||t-test, 2 sided|||||||0.87
72388436|NCT01611155|144284769|SUPERIORITY|||||||0.53|||||||t-test, 2 sided|||Motor subscale||||0.53
72388437|NCT01611155|144284769|SUPERIORITY|||||||0.89|||||||t-test, 2 sided|||autonomic subscale||||0.89
72388438|NCT02012283|144284793|OTHER|paired t-test|Mean Difference (Final Values)|78.4||||0.001|TWO_SIDED|95.0||||p\<0.05 is defined as significant|t-test, 2 sided|||Difference between plain and spiced broccoli intake was compared.||||0.001
72388439|NCT02012283|144284794|OTHER|paired t-test|Mean Difference (Final Values)|101.3||||0.031|TWO_SIDED|||||p\<0.05 is defined as significant.|t-test, 2 sided|||Comparison was made to the broccoli intake with and without spices among low restraint eaters vs. the change among high restraint eaters.||||0.031
72388440|NCT00453063|144284813|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001||95.0|||||ANCOVA|||||||0.001
72388441|NCT00453063|144284814|SUPERIORITY_OR_OTHER_LEGACY|||||||0.304||95.0|||||ANCOVA|||||||0.304
72388442|NCT00453063|144284815|SUPERIORITY_OR_OTHER_LEGACY|||||||0.004||95.0|||||ANCOVA|||||||0.004
72388443|NCT00453063|144284816|SUPERIORITY_OR_OTHER_LEGACY|||||||0.063||95.0|||||ANCOVA|||||||0.063
72388444|NCT00453063|144284817|SUPERIORITY_OR_OTHER_LEGACY|||||||0.356||95.0|||||ANCOVA|||||||0.356
72388445|NCT00289783|144284820|EQUIVALENCE|Criteria for lot-to-lot consistency (1 month after primary vaccination): For each pair of lots and for the immune response to anti-PRP measured by Enzyme Linked Immunosorbent Assay (ELISA) the two-sided 95% confidence interval (CI) on the geometric mean concentrations (GMCs) ratio between lots is within the \[0.5; 2.0\] interval.|GMC ratio|1.12|||||TWO_SIDED|95.0|0.89|1.42||||||To demonstrate the lot-to-lot consistency of 3 manufacturing lots of Hib-MenCY-TT vaccine co-administered with DTPa-HBV-IPV vaccine following 3 primary doses in terms of immunogenicity for polyribosylribitol phosphate (PRP) as measured by ELISA.||1.42|0.89|
72388446|NCT00289783|144284820|EQUIVALENCE|Criteria for lot-to-lot consistency (1 month after primary vaccination): For each pair of lots and for the immune response to anti-PRP measured by ELISA the two-sided 95% confidence interval (CI) on the geometric mean concentrations (GMCs) ratio between lots is within the \[0.5; 2.0\] interval.|GMC ratio|1.12|||||TWO_SIDED|95.0|0.89|1.42||||||To demonstrate the lot-to-lot consistency of 3 manufacturing lots of Hib-MenCY-TT vaccine co-administered with DTPa-HBV-IPV vaccine following 3 primary doses in terms of immunogenicity for polyribosylribitol phosphate (PRP) as measured by ELISA.||1.42|0.89|
72388447|NCT00289783|144284820|EQUIVALENCE|Criteria for lot-to-lot consistency (1 month after primary vaccination): For each pair of lots and for the immune response to anti-PRP measured by ELISA the two-sided 95% confidence interval (CI) on the geometric mean concentrations (GMCs) ratio between lots is within the \[0.5; 2.0\] interval.|GMC ratio|1.0|||||TWO_SIDED|95.0|0.8|1.26||||||To demonstrate the lot-to-lot consistency of 3 manufacturing lots of Hib-MenCY-TT vaccine co-administered with DTPa-HBV-IPV vaccine following 3 primary doses in terms of immunogenicity for polyribosylribitol phosphate (PRP) as measured by ELISA.||1.26|0.8|
72388448|NCT00289783|144284821|EQUIVALENCE|For each pair of lots and for the immune response to hSBA-MenC, the two-sided 95% confidence interval (CI) on the geometric mean titers (GMTs) ratio between lots is within the \[0.5; 2.0\] interval.|GMT ratio|1.23|||||TWO_SIDED|95.0|0.93|1.62||||||To demonstrate the lot-to-lot consistency of 3 manufacturing lots of Hib-MenCY-TT vaccine co-administered with DTPa-HBV-IPV vaccine following 3 primary doses in terms of immunogenicity for N. meningitidis serogroup C (MenC) as measured by a serum bactericidal assay using human complement (hSBA).||1.62|0.93|
72388449|NCT00289783|144284821|EQUIVALENCE|For each pair of lots and for the immune response to hSBA-MenC, the two-sided 95% confidence interval (CI) on the geometric mean titers (GMTs) ratio between lots is within the \[0.5; 2.0\] interval.|GMT ratio|0.97|||||TWO_SIDED|95.0|0.74|1.29||||||To demonstrate the lot-to-lot consistency of 3 manufacturing lots of Hib-MenCY-TT vaccine co-administered with DTPa-HBV-IPV vaccine following 3 primary doses in terms of immunogenicity for N. meningitidis serogroup C (MenC) as measured by a serum bactericidal assay using human complement (hSBA).||1.29|0.74|
72388450|NCT00289783|144284821|EQUIVALENCE|For each pair of lots and for the immune response to hSBA-MenC, the two-sided 95% confidence interval (CI) on the geometric mean titers (GMTs) ratio between lots is within the \[0.5; 2.0\] interval.|GMT ratio|0.79|||||TWO_SIDED|95.0|0.6|1.04||||||To demonstrate the lot-to-lot consistency of 3 manufacturing lots of Hib-MenCY-TT vaccine co-administered with DTPa-HBV-IPV vaccine following 3 primary doses in terms of immunogenicity for N. meningitidis serogroup C (MenC) as measured by a serum bactericidal assay using human complement (hSBA).||1.04|0.6|
72496514|NCT01360645|144522691|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.54||||0.127|TWO_SIDED|95.0|-3.52|0.44|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||Statistical analysis for Week 14||0.44|-3.52|0.1270
72559803|NCT01971554|144650070|SUPERIORITY_OR_OTHER||Difference in the least squares means|36.0|||||TWO_SIDED|90.0|20.0|51.9|||||A cLDA model was used to fit to the FPG data from the MK-8666 dose groups and placebo. Time was treated as a categorical variable so that no restriction was imposed on the trajectory of the means over time.|||51.9|20.0|
72619123|NCT01550965|144769014|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||McNemar|||Statistical analysis for percentage of participants with absence of blood in stool from week 0 to week 26.||||<0.001
72442797|NCT04310735|144398376|OTHER|Independent-samples t-tests were conducted to compare the mean contrast of parameter estimate (COPE) values, derived from the contrast of smoking-related versus neutral cue activation, between the Expect-Yes and Expect-No groups in the dorsal anterior cingulate cortex region of interest.||||||0.25||||||Statistical significance was defined a priori as p\<0.05.|t-test, 2 sided|||The null hypothesis was that there is no difference in the population means of the two groups.||||.25
72496515|NCT01360645|144522692|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.28||||0.3079|TWO_SIDED|95.0|-0.81|0.26|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||For Item: Work/School: Week 11||0.26|-0.81|0.3079
72496516|NCT01360645|144522692|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.19||||0.4771|TWO_SIDED|95.0|-0.73|0.34|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||For Item: Work/School: Week 14||0.34|-0.73|0.4771
72496517|NCT01360645|144522692|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5||||0.0195|TWO_SIDED|95.0|-0.92|-0.08|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||For Item: Social life: Week 11||-0.08|-0.92|0.0195
72496518|NCT01360645|144522692|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5||||0.0323|TWO_SIDED|95.0|-0.96|-0.04|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||For Item: Social life: Week 14||-0.04|-0.96|0.0323
72496519|NCT01360645|144522692|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.63||||0.0058|TWO_SIDED|95.0|-1.07|-0.18|||Cochran-Mantel-Haenszel|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||For Item: Family life: Week 11||-0.18|-1.07|0.0058
72496520|NCT01360645|144522692|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6||||0.0129|TWO_SIDED|95.0|-1.07|-0.13|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||For Item: Family life: Week 14||-0.13|-1.07|0.0129
72496521|NCT01360645|144522693|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.18||||0.5151|TWO_SIDED|95.0|-0.71|0.36|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||Statistical analysis for Item: Work/School Week 11||0.36|-0.71|0.5151
72496522|NCT01360645|144522693|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.15||||0.608|TWO_SIDED|95.0|-0.7|0.41|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||Statistical analysis for Item: Work/School Week 14||0.41|-0.70|0.6080
72559804|NCT01971554|144650070|SUPERIORITY_OR_OTHER||Difference in the least squares means|54.1|||||TWO_SIDED|90.0|38.1|70.0|||||A cLDA model was used to fit to the FPG data from the MK-8666 dose groups and placebo. Time was treated as a categorical variable so that no restriction was imposed on the trajectory of the means over time.|||70.0|38.1|
72559805|NCT01971554|144650076|SUPERIORITY_OR_OTHER||Difference in the least squares means|22.3|||||TWO_SIDED|90.0|6.2|38.4|||||A cLDA model was used to fit to the FPG data from the MK-8666 dose groups and placebo. Time was treated as a categorical variable so that no restriction was imposed on the trajectory of the means over time.|||38.4|6.2|
72619124|NCT01550965|144769015|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.11|||<|0.001|TWO_SIDED|95.0|10.21|12.02|||Paired t-test, 2 sided|||Statistical analysis for mean change in SIBDQ: Total Score from week 0 to week 2.||12.02|10.21|<0.001
72496523|NCT01360645|144522693|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.49||||0.0267|TWO_SIDED|95.0|-0.92|-0.06|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||Statistical analysis for Item: Social life-Week 11||-0.06|-0.92|0.0267
72496524|NCT01360645|144522693|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.55||||0.0224|TWO_SIDED|95.0|-1.01|-0.08|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||Statistical analysis for Item: Social life-Week 14||-0.08|-1.01|0.0224
72496525|NCT01360645|144522693|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.56||||0.0146|TWO_SIDED|95.0|-1.01|-0.11|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||Statistical analysis for Item: Family life-Week 11||-0.11|-1.01|0.0146
72496526|NCT01360645|144522693|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.62||||0.0113|TWO_SIDED|95.0|-1.09|-0.14|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||Statistical analysis for Item: Family life-Week 14||-0.14|-1.09|0.0113
72496527|NCT01360645|144522694|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.34||||0.0001|TWO_SIDED|95.0|-3.47|-1.22|||ANCOVA|||ANCOVA\_Last observation carry forward (LOCF) model with treatment and trial site as main effects, and baseline (end of Phase A \[Week 8\]) value as a covariate was used.||-1.22|-3.47|0.0001
72496528|NCT01360645|144522695|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.29||||0.0002|TWO_SIDED|95.0|-3.47|-1.12|||ANCOVA|||||-1.12|-3.47|0.0002
72496529|NCT01360645|144522696|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.17||||0.0219|TWO_SIDED|95.0|-2.17|-0.17|||ANCOVA|||ANCOVA\_LOCF model with treatment and trial site as main effects, and baseline (end of Phase A \[Week 8\]) value as a covariate was used.||-0.17|-2.17|0.0219
72496530|NCT01360645|144522697|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.09||||0.0376|TWO_SIDED|95.0|-2.13|-0.06|||ANCOVA|||||-0.06|-2.13|0.0376
72496531|NCT01360645|144522698|SUPERIORITY_OR_OTHER||Ratio of Response Rate|1.63||||0.0176|TWO_SIDED|95.0|1.09|2.44|||Cochran-Mantel-Haenszel|CHM general association test controlling for trial site.||||2.44|1.09|0.0176
72496532|NCT01360645|144522699|SUPERIORITY_OR_OTHER||Ratio of Response Rate|1.54||||0.0429|TWO_SIDED|95.0|1.01|2.35|||Cochran-Mantel-Haenszel|CHM general association test controlling for trial site.||||2.35|1.01|0.0429
72496533|NCT01360645|144522700|SUPERIORITY_OR_OTHER||Ratio of Remission Rate|1.68||||0.0586|TWO_SIDED|95.0|0.98|2.86|||Cochran-Mantel-Haenszel|CHM general association test controlling for trial site.||||2.86|0.98|0.0586
72442798|NCT04310735|144398377|OTHER|Independent-samples t-tests were conducted to compare mean valence values during smoking-related cues between the Expect-Yes and Expect-No groups.||||||0.8|||||||t-test, 2 sided|Statistical significance was defined a priori as p\<0.05.||The null hypothesis was that there is no difference in the population means of the two groups.||||.80
72442799|NCT04310735|144398377|OTHER|Independent-samples t-tests were conducted to compare mean valence values during neutral cues between the Expect-Yes and Expect-No groups.||||||0.87||||||Statistical significance was defined a priori as p\<0.05.|t-test, 2 sided|||The null hypothesis was that there is no difference in the population means of the two groups.||||.87
72442800|NCT05768373|144398420|NON_INFERIORITY|This study used a non-inferiority margin of 15 mm.|Mean Difference (Final Values)|0.3|||||TWO_SIDED|95.0|-3.4|4.0|||||The difference is 3M Clinpro minus 3M Vanish.|||4.0|-3.4|
72442801|NCT05768373|144398421|NON_INFERIORITY|This study used a non-inferiority margin of 15 mm.|Mean Difference (Final Values)|1.3|||||TWO_SIDED|95.0|-2.6|5.3|||||The difference is 3M Clinpro minus 3M Vanish.|||5.3|-2.6|
72442802|NCT05768373|144398422|NON_INFERIORITY|This study used a non-inferiority margin of 15 mm.|Mean Difference (Final Values)|1.7|||||TWO_SIDED|95.0|-3.2|6.7|||||The difference is 3M Clinpro minus 3M Vanish.|||6.7|-3.2|
72442803|NCT05768373|144398423|NON_INFERIORITY|This study used a non-inferiority margin of 15 mm.|Mean Difference (Final Values)|2.2|||||TWO_SIDED|95.0|-3.0|7.4|||||The difference is 3M Clinpro minus 3M Vanish.|||7.4|-3.0|
72442804|NCT05768373|144398424|NON_INFERIORITY|This study used a non-inferiority margin of 15 mm.|Mean Difference (Final Values)|1.9|||||TWO_SIDED|95.0|-4.4|8.2|||||The difference is 3M Clinpro minus 3M Vanish.|||8.2|-4.4|
72496534|NCT01360645|144522701|SUPERIORITY_OR_OTHER||Ratio of Remission Rate|1.67||||0.0671|TWO_SIDED|95.0|0.97|2.9|||Cochran-Mantel-Haenszel|CHM general association test controlling for trial site.||||2.90|0.97|0.0671
72619125|NCT01550965|144769015|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|15.38|||<|0.001|TWO_SIDED|95.0|14.2|16.56|||Paired t-test, 2 sided|||Statistical analysis for mean change in SIBDQ: Total Score from week 0 to week 8.||16.56|14.20|<0.001
72496535|NCT01360645|144522702|SUPERIORITY_OR_OTHER||Ratio of Response Rate|1.61||||0.0003|TWO_SIDED|95.0|1.23|2.1|||Cochran-Mantel-Haenszel|CHM general association test controlling for trial site.||||2.10|1.23|0.0003
72496536|NCT01360645|144522703|SUPERIORITY_OR_OTHER||Ratio of Response Rate|1.69||||0.0002|TWO_SIDED|95.0|1.27|2.27|||Cochran-Mantel-Haenszel|CHM general association test controlling for trial site.||||2.27|1.27|0.0002
72496537|NCT01014585|144522709|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.44||||0.0004|TWO_SIDED|95.0|0.27|0.71|||Log Rank|||||0.71|0.27|0.0004
72496538|NCT01014585|144522709|SUPERIORITY_OR_OTHER||Days until LTR at the 25th percentile|18.0||||||95.0||||||||||||
72496539|NCT01014585|144522709|SUPERIORITY_OR_OTHER||Days until LTR at the 25th percentile|45.0||||||95.0||||||||||||
72496540|NCT01014585|144522710|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.36||||0.0002|TWO_SIDED|95.0|0.2|0.63|||Log Rank|||||0.63|0.20|0.0002
72496541|NCT01014585|144522710|SUPERIORITY_OR_OTHER||Days until LTR at the 25th percentile|22.0||||||95.0||||||||||||
72442805|NCT03398200|144398436|SUPERIORITY|||||||0.89|||||||Regression, Cox|1- degree of freedom (1-df) likelihood ratio test (LRT) in a cell dose stratified Cox model||||||0.89
72442806|NCT03398200|144398437|SUPERIORITY|||||||0.03|||||||Regression, Cox|1- degree of freedom (1-df) likelihood ratio test (LRT) in a cell dose stratified Cox model||||||0.03
72442807|NCT03398200|144398438|SUPERIORITY|||||||0.35|||||||Regression, Cox|1- degree of freedom (1-df) likelihood ratio test (LRT) in a cell dose stratified Cox model||||||0.35
72442808|NCT03398200|144398439|SUPERIORITY|||||||0.77|||||||Regression, Cox|1- degree of freedom (1-df) likelihood ratio test (LRT) in a cell dose stratified Cox model||||||0.77
72442809|NCT03398200|144398440|SUPERIORITY|||||||0.5|||||||Regression, Cox|1- degree of freedom (1-df) likelihood ratio test (LRT) in a cell dose stratified Cox model||||||0.50
72442810|NCT03398200|144398441|SUPERIORITY|||||||0.76|||||||Regression, Cox|1- degree of freedom (1-df) likelihood ratio test (LRT) in a cell dose stratified Cox model||||||0.76
72442811|NCT05478525|144398443|SUPERIORITY||Least Squares (LS) Mean Difference|-35.05||||0.0007|TWO_SIDED|95.0|-54.35|-15.75|||ANCOVA|||Analysis at Week 2||-15.75|-54.35|0.0007
72442812|NCT05478525|144398443|SUPERIORITY||LS Mean Difference|-23.14||||0.0193|TWO_SIDED|95.0|-42.32|-3.97|||ANCOVA|||Analysis at Week 2||-3.97|-42.32|0.0193
72442813|NCT05478525|144398443|SUPERIORITY||LS Mean Difference|-21.64||||0.0243|TWO_SIDED|95.0|-40.33|-2.96|||ANCOVA|||Analysis at Week 2||-2.96|-40.33|0.0243
72442814|NCT05478525|144398445|SUPERIORITY||LS Mean Difference|-155.68||||0.0298|TWO_SIDED|95.0|-295.35|-16.01|||ANCOVA|||Analysis at Day 14||-16.01|-295.35|0.0298
72442815|NCT05478525|144398445|SUPERIORITY||LS Mean Difference|-143.74||||0.0433|TWO_SIDED|95.0|-282.92|-4.55|||ANCOVA|||Analysis at Day 14||-4.55|-282.92|0.0433
72442816|NCT05478525|144398445|SUPERIORITY||LS Mean Difference|-178.33||||0.0201|TWO_SIDED|95.0|-327.16|-29.5|||ANCOVA|||Analysis at Day 14||-29.50|-327.16|0.0201
72442817|NCT05478525|144398446|SUPERIORITY||LS Mean Difference|-47.07||||0.1992|TWO_SIDED|95.0|-119.94|25.81|||ANCOVA|||Analysis at Day 14||25.81|-119.94|0.1992
72442818|NCT05478525|144398446|SUPERIORITY||LS Mean Difference|-70.32||||0.0617|TWO_SIDED|95.0|-144.26|3.61|||ANCOVA|||Analysis at Day 14||3.61|-144.26|0.0617
72442819|NCT05478525|144398446|SUPERIORITY||LS Mean Difference|-39.84||||0.2981|TWO_SIDED|95.0|-116.22|36.53|||ANCOVA|||Analysis at Day 14||36.53|-116.22|0.2981
72442820|NCT05644002|144398454|OTHER||Mean Difference (Final Values)|2.06||||0.71|TWO_SIDED|95.0|-9.09|13.21||The threshold for statistical significance was p\<.05.|t-test, 2 sided|Levene's test for equal variances was used. If significance is \<.05, equal variances are not assumed and reported results are adjusted accordingly.||An independent-samples t-test was conducted to examine differences in post-stress-induction Omax between the PTBT and Control conditions.||13.21|-9.09|.71
72442821|NCT05644002|144398454|OTHER||t-statistic|0.369|||||TWO_SIDED||||||t-test, 2 sided|degrees freedom = 66||An independent-samples t-test was conducted to examine differences in post-stress induction Omax between the PTBT and Control conditions.||||
72442822|NCT05644002|144398454|OTHER||Hedge's g|0.09|||||TWO_SIDED||||||t-test, 2 sided|||An independent-samples t-test was conducted to examine differences in post-stress-induction Omax between the PTBT and Control conditions.||||
72496542|NCT01014585|144522711|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.8||||0.4104|TWO_SIDED|95.0|0.46|1.38|||Log Rank|||||1.38|0.46|0.4104
72496543|NCT01014585|144522711|SUPERIORITY_OR_OTHER||Days until LTR at the 25th percentile|18.0||||||95.0||||||||||||
72496544|NCT01014585|144522711|SUPERIORITY_OR_OTHER||Days until LTR at the 25th percentile|30.0||||||95.0||||||||||||
72442823|NCT05644002|144398455|OTHER||Mean Difference (Final Values)|0.251||||0.53|TWO_SIDED|95.0|-0.543|1.046||The threshold for statistical significance was p\<.05.|t-test, 2 sided|Levene's test for equal variances was used. If significance is \<.05, equal variances are not assumed and reported results are adjusted accordingly.||An independent-samples t-test was conducted to examine differences in post-stress induction mCEQ cigarette satisfaction between the PTBT and Control conditions.||1.046|-.543|.530
72442824|NCT05644002|144398455|OTHER||t-statistic|0.631|||||TWO_SIDED||||||t-test, 2 sided|degrees freedom = 73||An independent-samples t-test was conducted to examine differences in post-stress induction mCEQ cigarette satisfaction between the PTBT and Control conditions.||||
72442825|NCT05644002|144398455|OTHER||Hedge's g|0.14|||||TWO_SIDED||||||t-test, 2 sided|||An independent-samples t-test was conducted to examine differences in post-stress-induction mCEQ cigarette satisfaction between the PTBT and Control conditions.||||
72442826|NCT05644002|144398456|OTHER||Mean Difference (Final Values)|0.889||||0.66|TWO_SIDED|95.0|-3.149|4.927||The threshold for statistical significance was p\<.05.|t-test, 2 sided|Levene's test for equal variances was used. If significance is \<.05, equal variances are not assumed and reported results are adjusted accordingly.||An independent-samples t-test was conducted to examine differences in post-stress intensity between the PTBT and Control conditions.||4.927|-3.149|.66
72442827|NCT05644002|144398456|OTHER||t-statistic|0.439|||||TWO_SIDED||||||t-test, 2 sided|degrees of freedom = 66||An independent-samples t-test was conducted to examine differences in post-stress induction intensity between the PTBT and Control conditions.||||
72442828|NCT05644002|144398456|OTHER||Hedge's g|-0.11|||||TWO_SIDED||||||t-test, 2 sided|||An independent-samples t-test was conducted to examine differences in post-stress-induction intensity between the PTBT and Control conditions.||||
72496545|NCT00508391|144522741|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority hypothesis utilized an objective performance criteria of 63% with a clinically significant difference of 12%. For the non-inferiority hypothesis, the one-sided Type I error was set to 0.05 and the statistical power was set to 80%.|Objective Performance Criteria|63.0|||||ONE_SIDED|95.0|54.8||||Non-inferiority comparison|||"Efficacy was assessed in a non-inferiority, responder classification design where the proportion of total subjects classified as not worsened after changing from optimized to simultaneous biventricular pacing was compared to an objective performance criteria.~An effect of gender analysis was performed on the primary efficacy endpoint to compare the proportion of males and females classified as not worsened after changing from optimized to simultaneous biventricular pacing."|||54.8|
72559806|NCT01971554|144650076|SUPERIORITY_OR_OTHER||Difference in the least squares means|30.6|||||TWO_SIDED|90.0|17.4|43.8|||||A cLDA model was used to fit to the FPG data from the MK-8666 dose groups and placebo. Time was treated as a categorical variable so that no restriction was imposed on the trajectory of the means over time.|||43.8|17.4|
72496546|NCT00508391|144522742|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority hypothesis has a one-sided Type I error of 0.05 with an 80% statistical power.|Objective Performance Criteria|100.0|||||ONE_SIDED|95.0|97.6||||Non-inferiority comparison|||Safety will be evaluated in a non-inferiority format. The null hypothesis is the percent of subjects that did not experience an adverse event with an active interventricular delay feature at two months is inferior to 90% with a clinically significant difference of 10%|||97.6|
72496547|NCT01225562|144522756|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.85||||0.008|TWO_SIDED|95.0|0.75|0.96|||Regression, Cox||The hazard ratio shows ticagrelor 90 mg hazard / placebo hazard|||0.96|0.75|0.0080
72559807|NCT01971554|144650076|SUPERIORITY_OR_OTHER||Difference in the least squares means|48.8|||||TWO_SIDED|90.0|35.6|62.0|||||A cLDA model was used to fit to the FPG data from the MK-8666 dose groups and placebo. Time was treated as a categorical variable so that no restriction was imposed on the trajectory of the means over time.|||62.0|35.6|
72559808|NCT01426854|144650077|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Cochran-Mantel-Haenszel|||||||<0.0001
72442829|NCT05644002|144398457|OTHER||Mean Difference (Final Values)|-0.698||||0.77|TWO_SIDED|95.0|-5.443|4.046||The threshold for statistical significance was p\<.05.|t-test, 2 sided|Levene's test for equal variances was used. If significance is \<.05, equal variances are not assumed and reported results are adjusted accordingly.||An independent-samples t-test was conducted to examine differences in post-stress-induction Pmax between the PTBT and Control conditions.||4.046|-5.443|.77
72442830|NCT05644002|144398457|OTHER||t-statistic|-0.294|||||TWO_SIDED||||||t-test, 2 sided|degrees freedom = 66||An independent-samples t-test was conducted to examine differences in post-stress induction Pmax between the PTBT and Control conditions.||||
72442831|NCT05644002|144398457|OTHER||Hedge's g|-0.071|||||TWO_SIDED||||||t-test, 2 sided|||An independent-samples t-test was conducted to examine differences in post-stress-induction Pmax between the PTBT and Control conditions.||||
72442832|NCT05644002|144398458|OTHER||Mean Difference (Final Values)|-0.354||||0.9|TWO_SIDED|95.0|-6.009|5.3||The threshold for statistical significance was p\<.05.|t-test, 2 sided|Levene's test for equal variances was used. If significance is \<.05, equal variances are not assumed and reported results are adjusted accordingly.||An independent-samples t-test was conducted to examine differences in post-stress-induction breakpoint between the PTBT and Control conditions.||5.300|-6.009|.90
72442833|NCT05644002|144398458|OTHER||t-statistic|-0.125|||||TWO_SIDED||||||t-test, 2 sided|degrees of freedom = 66||An independent-samples t-test was conducted to examine differences in post-stress induction breakpoint between the PTBT and Control conditions.||||
72442834|NCT05644002|144398458|OTHER||Hedge's g|-0.03|||||TWO_SIDED||||||t-test, 2 sided|||An independent-samples t-test was conducted to examine differences in post-stress-induction breakpoint between the PTBT and Control conditions.||||
72442835|NCT05644002|144398459|OTHER||Mean Difference (Final Values)|-0.748||||0.09|TWO_SIDED|95.0|-1.601|0.105||The threshold for statistical significance was p\<.05.|t-test, 2 sided|Levene's test for equal variances was used. If significance is \<.05, equal variances are not assumed and reported results are adjusted accordingly.||An independent-samples t-test was conducted to examine differences in post-stress induction mCEQ craving reduction between the PTBT and Control conditions.||.105|-1.601|.09
72442836|NCT05644002|144398459|OTHER||t-statistic|-1.75|||||TWO_SIDED||||||t-test, 2 sided|degrees freedom = 65.261||An independent-samples t-test was conducted to examine differences in post-stress induction mCEQ craving reduction between the PTBT and Control conditions.||||
72442837|NCT05644002|144398459|OTHER||Hedge's g|-0.405|||||TWO_SIDED||||||t-test, 2 sided|||An independent-samples t-test was conducted to examine differences in post-stress-induction mCEQ craving reduction between the PTBT and Control conditions.||||
72442838|NCT05644002|144398460|OTHER||Mean Difference (Final Values)|0.184||||0.666|TWO_SIDED|95.0|-0.663|1.031||The threshold for statistical significance was p\<.05|t-test, 2 sided|Levene's test for equal variances was used. If significance is \<.05, equal variances are not assumed and reported results are adjusted accordingly.||An independent-samples t-test was conducted to examine differences in post-stress induction mCEQ psychological reward between the PTBT and Control conditions.||1.031|-.663|.666
72442839|NCT05644002|144398460|OTHER||t-statistic|0.184|||||TWO_SIDED||||||t-test, 2 sided|degrees freedom = 73||An independent-samples t-test was conducted to examine differences in post-stress induction mCEQ psychological reward between the PTBT and Control conditions.||||
72442840|NCT05644002|144398460|OTHER||Hedge's g|0.099|||||TWO_SIDED||||||t-test, 2 sided|||An independent-samples t-test was conducted to examine differences in post-stress-induction mCEQ psychological reward between the PTBT and Control conditions.||||
72496548|NCT01225562|144522756|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.84||||0.0043|TWO_SIDED|95.0|0.74|0.95|||Regression, Cox||The hazard ratio shows ticagrelor 60 mg hazard / placebo hazard|||0.95|0.74|0.0043
72496549|NCT01225562|144522757|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.87||||0.1547|TWO_SIDED|95.0|0.71|1.06|||Regression, Cox||The hazard ratio shows ticagrelor 90 mg hazard / placebo hazard|||1.06|0.71|0.1547
72496550|NCT01225562|144522757|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.83||||0.0676|TWO_SIDED|95.0|0.68|1.01|||Regression, Cox||The hazard ratio shows ticagrelor 60 mg hazard / placebo hazard|||1.01|0.68|0.0676
72496551|NCT01225562|144522758|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.0||||0.9851|TWO_SIDED|95.0|0.86|1.16|||Regression, Cox||The hazard ratio shows ticagrelor 90 mg hazard / placebo hazard|||1.16|0.86|0.9851
72559809|NCT03505151|144650086|OTHER||Ratio T/R|44.63|STANDARD_ERROR_OF_MEAN|36.9||||90.0|32.62|61.06|||||Standard Error of the mean is actually Intra-individual geometric coefficient of variation (gCV) of the mean|Absolute bioavailability was evaluated using an Analysis of variance model (ANOVA) on BI 409306 AUC0-inf versus 0.1 mg BI 409306 C-13/N-15 i.v. This model included effects accounting for the following sources of variation: 'subjects' and 'formulation'. The effect 'subjects' was considered as random, whereas 'formulation' was considered as fixed. The dose normalised PK endpoints were log transformed (natural logarithm) prior to fitting the ANOVA model.||61.06|32.62|
72559810|NCT03505151|144650087|OTHER||Ratio T/R|47.25|STANDARD_ERROR_OF_MEAN|68.8||||90.0|27.38|81.55|||||Standard Error of the mean is actually Intra-individual geometric coefficient of variation (gCV) of the mean|Ratios of BI 409306 for Cmax versus 0.1 mg BI 409306 C-13/N-15 i.v. was evaluated using ANOVA model. This model included effects accounting for the following sources of variation: 'subjects' and 'formulation'. The effect 'subjects' was considered as random, whereas 'formulation' was considered as fixed. The dose normalised PK endpoints were log transformed (natural logarithm) prior to fitting the ANOVA model.||81.55|27.38|
72619126|NCT01550965|144769015|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.77|||<|0.001|TWO_SIDED|95.0|13.57|15.96|||Paired t-test, 2 sided|||Statistical analysis for mean change in SIBDQ: Total Score from week 0 to week 18. Efficacy assessments were not specified at week 18; missing data at week 18 were imputed using last observation carried forward (LOCF).||15.96|13.57|<0.001
72496552|NCT01225562|144522758|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.89||||0.135|TWO_SIDED|95.0|0.76|1.04|||Regression, Cox||The hazard ratio shows ticagrelor 60 mg hazard / placebo hazard|||1.04|0.76|0.1350
72496553|NCT01225562|144522759|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.69|||<|0.0001|TWO_SIDED|95.0|1.96|3.7|||Regression, Cox||The hazard ratio shows ticagrelor 90 mg hazard / placebo hazard|||3.70|1.96|<0.0001
72496554|NCT01225562|144522759|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.32|||<|0.0001|TWO_SIDED|95.0|1.68|3.21|||Regression, Cox||The hazard ratio shows ticagrelor 60 mg hazard / placebo hazard|||3.21|1.68|<0.0001
72496555|NCT01162421|144522771|SUPERIORITY_OR_OTHER||Difference in percentage|-1.3||||0.907|TWO_SIDED|95.0|-23.4|20.8|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||||20.8|-23.4|0.907
72496556|NCT01162421|144522772|SUPERIORITY_OR_OTHER||Difference in percentage|3.2||||0.762|TWO_SIDED|95.0|-17.7|24.1|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 6||24.1|-17.7|0.762
72619127|NCT01550965|144769015|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|17.4|||<|0.001|TWO_SIDED|95.0|16.08|18.73|||Paired t-test, 2 sided|||Statistical analysis for mean change in SIBDQ: Total Score from week 0 to week 26.||18.73|16.08|<0.001
72496557|NCT01162421|144522772|SUPERIORITY_OR_OTHER||Difference in percentage|-5.3||||0.65|TWO_SIDED|95.0|-28.1|17.5|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 24||17.5|-28.1|0.650
72496558|NCT01162421|144522773|SUPERIORITY_OR_OTHER||Least squares (LS) Mean Difference|-0.86|STANDARD_ERROR_OF_MEAN|0.382||0.027|TWO_SIDED|95.0|-1.62|-0.1||P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and baseline value as the covariate.|ANCOVA|The a priori threshold for statistical significance is P= 0.05.||Month 6||-0.10|-1.62|0.027
72442841|NCT05644002|144398461|OTHER||β|0.026||||0.73|TWO_SIDED|95.0|-0.358|0.507||The threshold for statistical significance was p\<.05.|Regression, Linear|Coding: Control=0, PTBT=1.||A multiple linear regression test was conducted to examine whether the PTBT intervention (versus control) significantly predicted post-stress-induction respiratory sinus arrhythmia during smoking, while controlling for average baseline respiratory sinus arrhythmia at step 1 of the model.||.507|-.358|.73
72442842|NCT05644002|144398461|OTHER||t-statistic|0.345|||||TWO_SIDED||||||Regression, Linear|degrees freedom = (2, 73)|Condition (0=control; 1=PTBT)|A multiple linear regression test was conducted to examine whether the PTBT intervention (versus control) significantly predicted post-stress induction respiratory sinus arrhythmia during smoking, while controlling for average baseline respiratory sinus arrythmia at step 1 of the model.||||
72442843|NCT05644002|144398462|OTHER||Mean Difference (Final Values)|-0.543||||0.001|TWO_SIDED|95.0|-0.772|-0.314||The threshold for statistical significance was p\<.05.|t-test, 2 sided|Levene's test for equal variances was used. If significance is \< .05, equal variances are not assumed and reported results are adjusted accordingly.||An independent samples t-test was conducted to examine differences in post-stress-induction average puff duration between PTBT and Control conditions.||-.314|-.772|.001
72442844|NCT05644002|144398462|OTHER||t-statistic|-4.739|||||TWO_SIDED||||||t-test, 2 sided|degrees freedom = 66.03||An independent samples t-test was conducted to examine differences in post-stress-induction average puff duration between PTBT and Control conditions.||||
72442845|NCT05644002|144398462|OTHER||Hedge's g|-1.05|||||TWO_SIDED||||||t-test, 2 sided|||An independent-samples t-test was conducted to examine differences in post-stress-induction average puff duration between the PTBT and Control conditions.||||
72442846|NCT03821844|144398522|SUPERIORITY||marginal interaction effect|1.33|STANDARD_ERROR_OF_MEAN|1.38|<|0.05|TWO_SIDED|95.0|-1.37|4.03|||Differences-in-Differences regression||||"Fixed effects: age, sex, race, activities of daily living score, cognitive function score, psychotic disorder, bipolar disease, depression, anxiety, dementia, antidepressant use, antianxietal use, antipsychotic use, corporation, time from Minimum Data Set (MDS) collection to Cohen-Mansfield Agitation Inventory (CMAI) score (exclusive to CMAI model), baseline Agitation and Reactive Behavior Scale (ARBS) (exclusive to CMAI model), baseline CMAI (exclusive to ARBS and ARBS-CMAI model), indicator of baseline/follow-up score, treatment group, interaction of baseline/follow-up measure, and treatment group.~Random effects: random intercept for nursing home, random intercept for the interaction of baseline/follow-up measure and nursing home, random intercept for data collector (exclusive to CMAI model), and random intercept for individual."|4.03|-1.37|< 0.05
72442847|NCT03821844|144398523|SUPERIORITY||marginal interaction effect|0.06|||<|0.05|TWO_SIDED|95.0|0.03|0.09|||Differences-in-Differences regression||Reported estimation details pertain to the None category.||"The intention-to-treat (ITT) analysis used Bayesian multi-level multinomial logit models. All models adjust for resident baseline covariates, an individual-level effect to account for multiple observations for the same resident, and a facility level effect to account for variability in the outcomes for individuals residing in the same nursing homes. The reference category for the multinomial model for each outcome is None. To address baseline differences in the proportion of individuals at each level of the ordinal outcomes between treatment and control groups, we report the marginal time by intervention interaction."|0.09|0.03|< 0.05
72442848|NCT03821844|144398524|SUPERIORITY||Marginal Interaction Effect|-0.11|STANDARD_ERROR_OF_MEAN|0.1|<|0.05|TWO_SIDED|95.0|-0.3|0.08|||Differences-in-Differences regression||||"Fixed effect covariates: age, sex, race, activities of daily living score, cognitive function score, psychotic disorder, bipolar disease, depression, anxiety, dementia, antidepressant use, antianxietal use, antipsychotic use, nursing home corporation, time from Minimum Data Set (MDS) collection to Cohen-Mansfield Agitation Inventory (CMAI) score (exclusive to CMAI model), baseline Agitation and Reactive Behavior Score (ARBS) (exclusive to CMAI model), baseline CMAI (exclusive to ARBS and ARBS-CMAI model), indicator of baseline/follow-up score, treatment group, interaction of baseline/follow-up measure, and treatment group.~Random effects: random intercept for nursing home, random intercept for the interaction of baseline/follow-up measure and nursing home, random intercept for data collector (exclusive to CMAI model), and random intercept for individual."|0.08|-0.30|< 0.05
72442849|NCT03821844|144398525|SUPERIORITY||average marginal effect|-3.61|STANDARD_ERROR_OF_MEAN|1.85|<|0.05|TWO_SIDED|95.0|-7.22|0.0|||Differences-in-Differences regression||||Variables included in the model: baseline medication use, age, sex, race, activities of daily living score, cognitive function score, psychotic diagnosis, depression, anxiety, dementia, asthma, agitation and reactive behavior (ARBS) score, date of assessment, treatment group, and facility-level random effect.|0.00|-7.22|< 0.05
72442850|NCT03821844|144398526|SUPERIORITY||average marginal effect|-3.47|STANDARD_ERROR_OF_MEAN|2.08|<|0.05|TWO_SIDED|95.0|-7.55|0.06|||Differences-in-Differences regression||||Variables included in the model: baseline medication use, age, sex, race, activities of daily living score, cognitive function score, psychotic diagnosis, depression, anxiety, dementia, asthma, agitation and reactive behavior (ARBS) score, date of assessment, treatment group, and facility-level random effect.|0.06|-7.55|< 0.05
72442851|NCT03821844|144398527|SUPERIORITY||average marginal effect|-1.26|STANDARD_ERROR_OF_MEAN|2.05|<|0.05|TWO_SIDED|95.0|-5.28|2.76|||Differences-in-Differences regression||||Variables included in the model: baseline medication use, age, sex, race, activities of daily living score, cognitive function score, psychotic diagnosis, depression, anxiety, dementia, asthma, agitation and reactive behavior (ARBS) score, date of assessment, treatment group, and facility-level random effect.|2.76|-5.28|< 0.05
72559811|NCT01942135|144650093|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.422|||<|1e-06|TWO_SIDED|95.0|0.318|0.56||The overall Type-I error rate was persevered at 1-sided 0.025 level for the analysis of the primary endpoint PFS by the Haybittle-Peto efficacy boundary. The priori threshold for statistical significance was 0.00135.|Stratified Log Rank Test (1-sided)|The log rank test stratified by sensitivity to prior hormonal therapy and the presence of visceral metastases based on the randomization information.|Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of the palbociclib plus fulvestrant arm.|The primary hypothesis to be tested was H0: λ≥1 versus. HA: λ\<1, where λ was the palbociclib plus fulvestrant: placebo plus fulvestrant hazard ratio (HR). A HR less than 1 indicates a reduction in hazard rate in favor of Palbociclib + Fulvestrant. The study was planned to have 90% power and control the type-I error rate at 0.025.||0.560|0.318|<0.000001
72619128|NCT01550965|144769016|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.63|||<|0.001|TWO_SIDED|95.0|-0.69|-0.57|||Paired t-test, 2 sided|||Statistical analysis for mean change in PGA from week 0 to week 2.||-0.57|-0.69|<0.001
72442852|NCT03821844|144398529|SUPERIORITY||average marginal effect|-0.22|||<|0.05|TWO_SIDED|95.0|-1.14|0.7|||Differences-in-Differences regression||||Multilevel regression with covariates' adjustments was used to estimate the impact of the resident being in a treatment versus control nursing home on depressive symptoms.|0.70|-1.14|< 0.05
72442853|NCT03821844|144398530|SUPERIORITY||marginal interaction effect|0.0|||<|0.05|TWO_SIDED|95.0|-0.03|0.02|||Differences-in-Differences regression||Reported estimation details pertain to the None category.||The intention-to-treat (ITT) analysis used Bayesian multi-level multinomial logit models to analyze the effect that being in a treatment versus control nursing home had on the behaviors of nursing home residents. All models adjust for resident baseline covariates and the activity status of a resident during an observation. In addition, they include an individual-level effect to account for multiple observations for the same resident, and a facility level effect to account for variability in the outcomes for individuals residing in the same nursing homes. To address baseline differences in the proportion of individuals at each level of the ordinal outcomes between treatment and control groups, we report the marginal time by intervention interaction.|0.02|-0.03|< 0.05
72496559|NCT01162421|144522773|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.46|STANDARD_ERROR_OF_MEAN|0.667||0.033|TWO_SIDED|95.0|-2.79|-0.12||P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and baseline value as the covariate.|ANCOVA|The a priori threshold for statistical significance is P= 0.05.||Month 12||-0.12|-2.79|0.033
72496560|NCT01162421|144522773|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.22|STANDARD_ERROR_OF_MEAN|1.403||0.12|TWO_SIDED|95.0|-5.05|0.6||P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and baseline value as the covariate.|ANCOVA|||Month 24||0.60|-5.05|0.120
72496561|NCT01162421|144522774|SUPERIORITY_OR_OTHER||Difference in percentage|-11.7||||0.095|TWO_SIDED|95.0|-27.0|1.6||P-value is based on two sided Fisher's exact test.|Fisher Exact||Confidence interval is based on Wilson confidence limits.|||1.6|-27.0|0.095
72559812|NCT01942135|144650095|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.814|||=|0.0429|TWO_SIDED|95.0|0.644|1.029||1-sided p-value from the log-rank test stratified by the presence of visceral metastases and sensitivity to prior endocrine therapy per randomization.|Stratified Log Rank Test (1-sided)|The log rank test stratified by sensitivity to prior hormonal therapy and the presence of visceral metastases based on the randomization information.|Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of palbociclib plus fulvestrant.|The primary hypothesis to be tested was H0: λ≥1 versus. HA: λ\<1, where λ was the palbociclib plus fulvestrant: placebo plus fulvestrant hazard ratio (HR). A HR less than 1 indicates a reduction in hazard rate in favor of Palbociclib + Fulvestrant. The study was planned to have 90% power and control the type-I error rate at 0.025.||1.029|0.644|=0.0429
72442854|NCT03821844|144398531|SUPERIORITY||marginal interaction effect|0.05|||<|0.05|TWO_SIDED|95.0|0.02|0.07|||Differences-in-Differences regression||||The intention-to-treat (ITT) analysis used Bayesian multi-level multinomial logit models to analyze the effect that being in a treatment versus control nursing home had on the moods of nursing home residents. All models adjust for resident baseline covariates and the activity status of a resident during an observation. In addition, they include an individual-level effect to account for multiple observations for the same resident, and a facility level effect to account for variability in the outcomes for individuals residing in the same nursing homes. We report the marginal time by intervention interaction.|0.07|0.02|< 0.05
72442855|NCT03821844|144398532|SUPERIORITY||marginal interaction effect|-0.01|||<|0.05|TWO_SIDED|95.0|-0.03|0.01|||Differences-in-Differences regression||||The intention-to-treat (ITT) analysis used Bayesian multi-level multinomial logit models to analyze the effect that being in a treatment versus control nursing home had on the moods of nursing home residents. All models adjust for resident baseline covariates and the activity status of a resident during an observation. In addition, they include an individual-level effect to account for multiple observations for the same resident, and a facility level effect to account for variability in the outcomes for individuals residing in the same nursing homes. We report the marginal time by intervention interaction.|0.01|-0.03|< 0.05
72442856|NCT03821844|144398533|SUPERIORITY||average marginal effect|-0.01|||<|0.05|TWO_SIDED|95.0|-0.04|0.01|||Differences-in-Differences regression||||The intention-to-treat (ITT) analysis used Bayesian multi-level multinomial logit models to analyze the effect that being in a treatment versus control nursing home had on the moods of nursing home residents. All models adjust for resident baseline covariates and the activity status of a resident during an observation. In addition, they include an individual-level effect to account for multiple observations for the same resident, and a facility level effect to account for variability in the outcomes for individuals residing in the same nursing homes. We report the marginal time by intervention interaction.|0.01|-0.04|< 0.05
72442857|NCT03821844|144398534|SUPERIORITY||marginal interaction effect|0.01|||<|0.05|TWO_SIDED|95.0|-0.02|0.03|||Differences-in-Differences regression||||The intention-to-treat (ITT) analysis used Bayesian multi-level multinomial logit models to analyze the effect that being in a treatment versus control nursing home had on the moods of nursing home residents. All models adjust for resident baseline covariates and the activity status of a resident during an observation. In addition, they include an individual-level effect to account for multiple observations for the same resident, and a facility level effect to account for variability in the outcomes for individuals residing in the same nursing homes. We report the marginal time by intervention interaction.|0.03|-0.02|< 0.05
72496562|NCT01162421|144522775|SUPERIORITY_OR_OTHER||Difference in percentage|12.1||||0.281|TWO_SIDED|95.0|-9.79|33.97|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 3||33.97|-9.79|0.281
72559813|NCT01942135|144650097|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.783||||0.0001|TWO_SIDED|95.0|1.563|5.603||The p-value was not adjusted for multiple comparisons. The priori threshold for statistical significance is 1-sided, alpha=0.025.|Exact test (1-sided)|The 1-sided p-value is from the stratified exact test.|An Odds Ratio \>1 means better response in favor of the palbociclib plus fulvestrant arm.|The exact test is testing the null hypothesis that the odds ratio of objective response rate is less than or equal to 1 vs. the alternative hypothesis that the odds ratio of objective response rate is greater than 1. An Odds Ratio \>1 means better response in favor of palbociclib plus fulvestrant arm.||5.603|1.563|0.0001
72496563|NCT01162421|144522775|SUPERIORITY_OR_OTHER||Difference in percentage|27.0||||0.021|TWO_SIDED|95.0|4.98|48.93||The a priori threshold for statistical significance is P=0.05.|Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 6||48.93|4.98|0.021
72496564|NCT01162421|144522775|SUPERIORITY_OR_OTHER||Difference in percentage|6.7||||0.552|TWO_SIDED|95.0|-15.29|28.63|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 9||28.63|-15.29|0.552
72496565|NCT01162421|144522775|SUPERIORITY_OR_OTHER||Difference in percentage|-12.2||||0.281|TWO_SIDED|95.0|-34.04|9.72|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 12||9.72|-34.04|0.281
72496566|NCT01162421|144522775|SUPERIORITY_OR_OTHER||Difference in percentage|-14.4||||0.209|TWO_SIDED|95.0|-36.64|7.78|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 18||7.78|-36.64|0.209
72496567|NCT01162421|144522775|SUPERIORITY_OR_OTHER||Difference in percentage|-19.6||||0.091|TWO_SIDED|95.0|-41.74|2.62|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 24||2.62|-41.74|0.091
72496568|NCT01162421|144522776|SUPERIORITY_OR_OTHER||Difference in percentage|15.6||||0.148|TWO_SIDED|95.0|-5.05|36.26|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 3||36.26|-5.05|0.148
72496569|NCT01162421|144522776|SUPERIORITY_OR_OTHER||Difference in percentage|20.7||||0.06|TWO_SIDED|95.0|-0.14|41.61|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 6||41.61|-0.14|0.060
72496570|NCT01162421|144522776|SUPERIORITY_OR_OTHER||Difference in percentage|8.7||||0.451|TWO_SIDED|95.0|-13.85|31.29|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 9||31.29|-13.85|0.451
72442858|NCT03821844|144398535|SUPERIORITY||marginal interaction effect|-0.02|||<|0.05|TWO_SIDED|95.0|-0.05|0.01|||Differences-in-Differences regression||||The intention-to-treat (ITT) analysis used Bayesian multi-level multinomial logit models to analyze the effect that being in a treatment vs. control NH had on the behaviors and moods of NH residents. The models were implemented separately for each mood. All models adjust for resident baseline covariates and the activity status of a resident during an observation. In addition, they include an individual-level effect to account for multiple observations for the same resident, and a facility level effect to account for variability in the outcomes for individuals residing in the same nursing homes. To address baseline differences in the proportion of individuals at each level of the ordinal outcomes between treatment and control groups, we report the marginal time by intervention interaction. We will refer to this estimand as the marginal interaction effect (MIE), which is sometimes known as the Difference in Differences estimand.|0.01|-0.05|< 0.05
72496571|NCT01162421|144522776|SUPERIORITY_OR_OTHER||Difference in percentage|9.3||||0.413|TWO_SIDED|95.0|-12.82|31.43|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 12||31.43|-12.82|0.413
72442859|NCT02605837|144398536|SUPERIORITY||Difference in proportion of responders|0.52|||<|0.001||95.0|0.433|0.591|||Cochran-Mantel-Haenszel|||The Cochran-Mantel-Haenszel (CMH) adjusted difference in proportion with corresponding Newcombe confidence interval (CI) and odds ratio with corresponding CI were based on CMH test stratified by age group and diet restriction.||0.591|0.433|<0.001
72442860|NCT02605837|144398537|SUPERIORITY||Difference in proportion of responders|0.13||||0.024||95.0|0.016|0.243|||Cochran-Mantel-Haenszel|||The CMH adjusted difference in proportion with corresponding Newcombe confidence interval (CI) and odds ratio with corresponding CI were based on CMH test stratified by age group and diet restriction.||0.243|0.016|0.024
72442861|NCT02605837|144398538|SUPERIORITY||Difference in Least square mean|-3.92||||0.015||95.0|-7.073|-0.774|||ANCOVA|||This analysis was from analysis of covariance (ANCOVA) model with treatment group and age group as factors and the baseline DSQ combined score as a continuous covariate.||-0.774|-7.073|0.015
72442862|NCT02605837|144398539|SUPERIORITY||Difference in Least square mean|-1.8|||<|0.001||95.0|-2.6|-1.1|||ANCOVA|||This analysis was from analysis of covariance (ANCOVA) model with treatment group and age group as factors and the baseline. Total EREFS (endoscopy score) as a continuous covariate.||-1.1|-2.6|<0.001
72442863|NCT02605837|144398540|SUPERIORITY||Odds Ratio (OR)|169.74|||<|0.001||95.0|23.235|1239.979|||Regression, Logistic|||Peak eosinophil count (\<15/HPF) was performed based on logistic regression model adjusted for age group and diet restriction.||1239.979|23.235|<0.001
72496572|NCT01162421|144522776|SUPERIORITY_OR_OTHER||Difference in percentage|-7.3||||0.528|TWO_SIDED|95.0|-29.74|15.23|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 18||15.23|-29.74|0.528
72496573|NCT01162421|144522776|SUPERIORITY_OR_OTHER||Difference in percentage|-9.5||||0.399|TWO_SIDED|95.0|-31.61|12.56|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 24||12.56|-31.61|0.399
72559814|NCT01942135|144650099|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|3.016|||<|0.0001|TWO_SIDED|95.0|2.046|4.565||The p-value was not adjusted for multiple comparisons. The priori threshold for statistical significance is 1-sided, alpha=0.025.|Exact test (1-sided)|The 1-sided p-value is from the stratified exact test.|An odds ratio \> 1 means better clinical benefit response in favor of palbociclib plus fulvestrant arm.|The exact test is testing the null hypothesis that the odds ratio of objective response rate is less than or equal to 1 vs. the alternative hypothesis that the odds ratio of objective response rate is greater than 1. An Odds Ratio \>1 means better response in favor of palbociclib plus fulvestrant arm.||4.565|2.046|<0.0001
72619129|NCT01550965|144769016|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.08|||<|0.001|TWO_SIDED|95.0|-1.16|-1.0|||Paired t-test, 2 sided|||Statistical analysis for mean change in PGA from week 0 to week 8.||-1.00|-1.16|<0.001
72442864|NCT02605837|144398540|SUPERIORITY||Odds Ratio (OR)|100.69||||0.001|TWO_SIDED|95.0|6.294|1610.749|||Firth logistic regression|||Peak eosinophil count (\<=1/HPF) was performed based on firth logistic regression model adjusted for age group and diet restriction.||1610.749|6.294|0.001
72442865|NCT02605837|144398541|SUPERIORITY||Difference in Least square mean|-28.4|||<|0.001||95.0|-35.0|-21.8|||ANCOVA|||This analysis of proximal eosinophil count was from the analysis of covariance (ANCOVA) model with treatment group and age group as factors and the baseline Peak Eosinophil Count as a continuous covariate.||-21.8|-35.0|<0.001
72442866|NCT02605837|144398541|SUPERIORITY||Difference in Least square mean|-30.4|||<|0.001||95.0|-38.1|-22.7|||ANCOVA|||This analysis of mid eosinophil count was from the analysis of covariance (ANCOVA) model with treatment group and age group as factors and the baseline Peak Eosinophil Count as a continuous covariate.||-22.7|-38.1|<0.001
72442867|NCT02605837|144398541|SUPERIORITY||Difference in Least square mean|-33.1|||<|0.001||95.0|-40.7|-25.5|||ANCOVA|||This analysis of distal eosinophil count was from the analysis of covariance (ANCOVA) model with treatment group and age group as factors and the baseline Peak Eosinophil Count as a continuous covariate||-25.5|-40.7|<0.001
72442868|NCT02605837|144398541|SUPERIORITY||Difference in LS Mean|-47.6|||<|0.001|TWO_SIDED|95.0|-56.4|-38.8|||ANCOVA|||This analysis of maximum eosinophil count was from the ANCOVA model with treatment group and age group as factors and the baseline Peak eosinophil count as a continuous covariate.||-38.8|-56.4|<0.001
72442869|NCT02605837|144398542|SUPERIORITY||Difference in Least square mean|-0.19|||<|0.001||95.0|-0.22|-0.16|||ANCOVA|||This analysis of histopathologic epithelial features combined grade TSR was from the analysis of covariance (ANCOVA) model with treatment group and age group as factors and the baseline Peak Eosinophil Count as a continuous covariate.||-0.16|-0.22|<0.001
72442870|NCT02605837|144398542|SUPERIORITY||Difference in Least square mean|-0.2|||<|0.001||95.0|-0.2|-0.2|||ANCOVA|||This analysis of histopathologic epithelial features combined stage TSR was from the analysis of covariance (ANCOVA) model with treatment group and age group as factors and the baseline Peak Eosinophil Count as a continuous covariate.||-0.2|-0.2|<0.001
72442871|NCT02605837|144398543|SUPERIORITY||Odds Ratio (OR)|1.42||||0.164|TWO_SIDED|95.0|0.866|2.333|||Regression, Logistic|||Dysphagia symptom response (binary response) at the final treatment period was performed based on logistic regression model adjusted for age group and diet restriction.||2.333|0.866|0.164
72496574|NCT01162421|144522777|SUPERIORITY_OR_OTHER||Difference in percentage|12.5||||0.111|TWO_SIDED|95.0|-1.7|27.06|||Fisher Exact|||Month 3||27.06|-1.70|0.111
72559815|NCT01942135|144650103|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.1||||0.0313|TWO_SIDED|95.0|0.3|6.0||The priori threshold for statistical significance is 2-sided alpha=0.05. The p-value was not adjusted for multiple comparisons.|Mixed Model Analysis (2-sided)|Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.||Statistical significance for palbociclib plus fulvestrant vs placebo plus fulvestrant for Global health status/ QoL||6.0|0.3|0.0313
72559816|NCT01942135|144650103|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.0||||0.4|TWO_SIDED|95.0|-1.4|3.5||The priori threshold for statistical significance is 2-sided alpha=0.05. The p-value was not adjusted for multiple comparisons.|Mixed Model Analysis (2-sided)|Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.||Statistical significance for palbociclib plus fulvestrant vs placebo plus fulvestrant for physical functioning||3.5|-1.4|0.4000
72559817|NCT01942135|144650103|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.9||||0.2615|TWO_SIDED|95.0|-1.5|5.3||The priori threshold for statistical significance is 2-sided alpha=0.05. The p-value was not adjusted for multiple comparisons.|Mixed Model Analysis (2-sided)|Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.||Statistical significance for palbociclib plus fulvestrant vs placebo plus fulvestrant for role functioning||5.3|-1.5|0.2615
72619130|NCT01550965|144769016|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.86|||<|0.001|TWO_SIDED|95.0|-0.95|-0.77|||Paired t-test, 2 sided|||Statistical analysis for mean change in PGA from week 0 to week 18. Efficacy assessments were not specified at week 18; missing data at week 18 were imputed using LOCF.||-0.77|-0.95|<0.001
72619131|NCT01550965|144769016|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.15|||<|0.001|TWO_SIDED|95.0|-1.23|-1.06|||Paired t-test, 2 sided|||Statistical analysis for mean change in PGA from week 0 to week 26.||-1.06|-1.23|<0.001
72388451|NCT00289783|144284822|EQUIVALENCE|For each pair of lots and for the immune response to hSBA-MenY, the two-sided 95% confidence interval (CI) on the geometric mean titers (GMTs) ratio between lots is within the \[0.5; 2.0\] interval.|GMT ratio|1.61|||||TWO_SIDED|95.0|1.14|2.27||||||To demonstrate the lot-to-lot consistency of 3 manufacturing lots of Hib-MenCY-TT vaccine co-administered with DTPa-HBV-IPV vaccine following 3 primary doses in terms of immunogenicity for N. meningitidis serogroup Y (MenY) as measured by a serum bactericidal assay using human complement (hSBA).||2.27|1.14|
72442872|NCT02605837|144398544|SUPERIORITY||Odds Ratio (OR)|91.86||||0.001|TWO_SIDED|95.0|5.687|1483.68|||Firth logistic regression|||Overall binary response I at the final treatment period was performed based on firth logistic regression model adjusted for age group and diet restriction.||1483.680|5.687|0.001
72442873|NCT02605837|144398545|SUPERIORITY||Odds Ratio (OR)|61.68||||0.004|TWO_SIDED|95.0|3.836|991.858|||Firth logistic regression|||Overall binary response II at the final treatment period was perfomed based on based on firth logistic regression model adjusted for age group and diet restriction.||991.858|3.836|0.004
72442874|NCT02605837|144398546|SUPERIORITY||Difference in Least square mean|-6.41||||0.004||95.0|-10.757|-2.063|||ANCOVA|||This analysis was from the analysis of covariance (ANCOVA) model with treatment group and age group as factors and the baseline DSQ + Pain score as a continuous covariate.||-2.063|-10.757|0.004
72442875|NCT02605837|144398547|SUPERIORITY||Difference in Least square mean|-2.46||||0.002||95.0|-4.018|-0.909|||ANCOVA|||This analysis was from the analysis of covariance (ANCOVA) model with treatment group and age group as factors and the baseline DSQ Pain score as a continuous covariate.||-0.909|-4.018|0.002
72442876|NCT02652260|144398556|OTHER|The Immediate Switch group will be considered statistically significantly smaller than the Delayed Switch group if the upper bound of the 95% confidence interval for the treatment difference is less than 0.|Estimated Difference|4.65||||0.331|TWO_SIDED|95.0|-15.92|24.85|||Miettinen and Nurminen|||Treatment Difference: Immediate Switch minus Delayed Switch|The 95% confidence interval (CI) was calculated by the method of Miettinen and Nurminen.|24.85|-15.92|0.331
72442877|NCT02652260|144398557|OTHER|The Immediate Switch group will be considered statistically significantly smaller than the Delayed Switch group if the upper bound of the 95% confidence interval for the treatment difference is less than 0.|Estimated Difference|-18.61|||||TWO_SIDED|95.0|-38.14|2.51||||||Treatment Difference: Immediate Switch minus Delayed Switch|The 95% CI was calculated by the method of Miettinen and Nurminen.|2.51|-38.14|
72442878|NCT02652260|144398558|OTHER||Estimated Difference|-2.0|||||TWO_SIDED|95.0|-10.5|6.5||||||Treatment Difference: Immediate Switch minus Delayed Switch|The 95% CI was based on a t-distribution.|6.5|-10.5|
72442879|NCT02652260|144398559|OTHER||Estimated Difference|3.6|||||TWO_SIDED|95.0|-4.1|11.3||||||Treatment Difference: Immediate Switch minus Delayed Switch|The 95% CI was calculated by the method of Miettinen and Nurminen.|11.3|-4.1|
72442880|NCT02652260|144398560|OTHER|The 95% CI was calculated by the method of Miettinen and Nurminen.|Difference in Percentage|-38.4|||||TWO_SIDED|95.0|-51.2|-23.8||||||Change from time of switch to 24 weeks post-switch: Treatment difference in percent response|Week 24 Post-switch minus Time of switch|-23.8|-51.2|
72442881|NCT02652260|144398561|OTHER|The 95% CI was based on a t-distribution.|Mean Difference (Final Values)|-13.4|||||TWO_SIDED|95.0|-16.8|-10.1||||||Change from time of switch to 24 weeks post-switch: Treatment difference in score|Week 24 Post-switch minus Time of switch|-10.1|-16.8|
72442882|NCT02652260|144398562|OTHER|The 95% CI for treatment difference was calculated from an ANCOVA model with terms for baseline lipid level, use of lipid lowering therapy at study Day 1 and treatment|Difference Estimate|-9.02|||||TWO_SIDED|95.0|-15.69|-2.35||||||Difference Estimate: LDL Cholesterol|ISG minus DSG|-2.35|-15.69|
72442883|NCT02652260|144398562|OTHER|The 95% CI for treatment difference was calculated from an ANCOVA model with terms for baseline lipid level, use of lipid lowering therapy at study Day 1 and treatment|Difference Estimate|-13.57|||||TWO_SIDED|95.0|-20.79|-6.35||||||Difference Estimate: Non-HDL Cholesterol|ISG minus DSG|-6.35|-20.79|
72442884|NCT02652260|144398562|OTHER|The 95% CI for treatment difference was calculated from an ANCOVA model with terms for baseline lipid level, use of lipid lowering therapy at study Day 1 and treatment|Difference Estimate|-21.42|||||TWO_SIDED|95.0|-29.63|-13.21||||||Difference Estimate: Cholesterol|ISG minus DSG|-13.21|-29.63|
72442885|NCT02652260|144398562|OTHER|The 95% CI for treatment difference was calculated from an ANCOVA model with terms for baseline lipid level, use of lipid lowering therapy at study Day 1 and treatment|Difference Estimate|-8.18|||||TWO_SIDED|95.0|-11.76|-4.6||||||Difference Estimate: HDL Cholesterol|ISG minus DSG|-4.60|-11.76|
72496575|NCT01162421|144522777|SUPERIORITY_OR_OTHER||Difference in percentage|19.6||||0.031|TWO_SIDED|95.0|2.74|36.53||The a priori threshold for statistical significance is P=0.05.|Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 6||36.53|2.74|0.031
72496576|NCT01162421|144522777|SUPERIORITY_OR_OTHER||Difference in percentage|2.8||||0.78|TWO_SIDED|95.0|-16.74|22.31|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 9||22.31|-16.74|0.780
72496577|NCT01162421|144522777|SUPERIORITY_OR_OTHER||Difference in percentage|16.5||||0.092|TWO_SIDED|95.0|-2.07|35.04|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 12||35.04|-2.07|0.092
72496578|NCT01162421|144522777|SUPERIORITY_OR_OTHER||Difference in percentage|10.8||||0.29|TWO_SIDED|95.0|-8.86|30.4|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 18||30.40|-8.86|0.290
72496579|NCT01162421|144522777|SUPERIORITY_OR_OTHER||Difference in percentage|-16.9||||0.116|TWO_SIDED|95.0|-37.86|4.01|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 24||4.01|-37.86|0.116
72496580|NCT01162421|144522778|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.5|STANDARD_ERROR_OF_MEAN|1.18||0.004|TWO_SIDED|95.0|-5.9|-1.2||P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and Baseline value as the covariate.|ANCOVA|The a priori threshold for statistical significance is P=0.01.||Month 3||-1.2|-5.9|0.004
72496581|NCT01162421|144522778|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.5|STANDARD_ERROR_OF_MEAN|1.12|<|0.001|TWO_SIDED|95.0|-6.8|-2.3||P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and Baseline value as the covariate.|ANCOVA|The a priori threshold for statistical significance is P=0.001.||Month 6||-2.3|-6.8|<0.001
72496582|NCT01162421|144522778|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.7|STANDARD_ERROR_OF_MEAN|1.16||0.021|TWO_SIDED|95.0|-5.1|-0.4||P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and Baseline value as the covariate.|ANCOVA|The a priori threshold for statistical significance is P=0.05.||Month 9||-0.4|-5.1|0.021
72496583|NCT01162421|144522778|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.0|STANDARD_ERROR_OF_MEAN|0.96||0.037|TWO_SIDED|95.0|-4.0|-0.1||P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and Baseline value as the covariate.|ANCOVA|The a priori threshold for statistical significance is P=0.05.||Month 12||-0.1|-4.0|0.037
72496584|NCT01162421|144522778|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|1.58||0.702|TWO_SIDED|95.0|-3.7|2.5||P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and Baseline value as the covariate.|ANCOVA|||Month 18||2.5|-3.7|0.702
72496585|NCT01162421|144522778|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|1.15||0.644|TWO_SIDED|95.0|-2.8|1.8||P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and Baseline value as the covariate.|ANCOVA|||Month 24||1.8|-2.8|0.644
72496586|NCT01162421|144522779|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.9|STANDARD_ERROR_OF_MEAN|0.89||0.039|TWO_SIDED|95.0|-3.7|-0.1||P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and Baseline value as the covariate.|ANCOVA|The a priori threshold for statistical significance is P=0.05.||Month 3||-0.1|-3.7|0.039
72496587|NCT01162421|144522779|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.4|STANDARD_ERROR_OF_MEAN|0.79|<|0.001|TWO_SIDED|95.0|-5.0|-1.8||P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and Baseline value as the covariate.|ANCOVA|The a priori threshold for statistical significance is P=0.001.||Month 6||-1.8|-5.0|<0.001
72559818|NCT01942135|144650103|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.6||||0.0016|TWO_SIDED|95.0|1.7|7.4||The priori threshold for statistical significance is 2-sided alpha=0.05. The p-value was not adjusted for multiple comparisons.|Mixed Model Analysis (2-sided)|Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.||Statistical significance for palbociclib plus fulvestrant vs placebo plus fulvestrant for emotional functioning||7.4|1.7|0.0016
72619132|NCT01550965|144769017|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.22|||<|0.001|TWO_SIDED|95.0|-3.46|-2.99|||Paired t-test, 2 sided|||Statistical analysis for mean change in total SCCAI from week 0 to week 2.||-2.99|-3.46|<0.001
72496588|NCT01162421|144522779|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.2|STANDARD_ERROR_OF_MEAN|0.81||0.008|TWO_SIDED|95.0|-3.8|-0.6||P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and Baseline value as the covariate.|ANCOVA|The a priori threshold for statistical significance is P=0.01.||Month 9||-0.6|-3.8|0.008
72496589|NCT01162421|144522779|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.6|STANDARD_ERROR_OF_MEAN|0.71||0.028|TWO_SIDED|95.0|-3.0|-0.2||P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and Baseline value as the covariate.|ANCOVA|The a priori threshold for statistical significance is P=0.05.||Month 12||-0.2|-3.0|0.028
72496590|NCT01162421|144522779|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.94||0.452|TWO_SIDED|95.0|-2.6|1.2||P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and Baseline value as the covariate.|ANCOVA|||Month 18||1.2|-2.6|0.452
72496591|NCT01162421|144522779|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.77||0.343|TWO_SIDED|95.0|-2.3|0.8||P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and Baseline value as the covariate.|ANCOVA|||Month 24||0.8|-2.3|0.343
72496592|NCT01162421|144522780|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.8|STANDARD_ERROR_OF_MEAN|2.26||0.22|TWO_SIDED|95.0|-7.3|1.7||P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and Baseline value as the covariate.|ANCOVA|||Month 3||1.7|-7.3|0.220
72496593|NCT01162421|144522780|SUPERIORITY_OR_OTHER||LS Mean Difference|-7.2|STANDARD_ERROR_OF_MEAN|1.92|<|0.001|TWO_SIDED|95.0|-11.0|-3.3||P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and Baseline value as the covariate.|ANCOVA|The a priori threshold for statistical significance is P=0.001.||Month 6||-3.3|-11.0|<0.001
72442886|NCT02652260|144398562|OTHER|The 95% CI for treatment difference was calculated from an ANCOVA model with terms for baseline lipid level, use of lipid lowering therapy at study Day 1 and treatment|Difference Estimate|-22.18|||||TWO_SIDED|95.0|-38.52|-5.84||||||Difference Estimate: Triglyceride|ISG minus DSG|-5.84|-38.52|
72496594|NCT01162421|144522780|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.7|STANDARD_ERROR_OF_MEAN|1.87||0.05|TWO_SIDED|95.0|-7.5|0.0||P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and Baseline value as the covariate.|ANCOVA|The a priori threshold for statistical significance is P=0.05.||Month 9||0.0|-7.5|0.050
72496595|NCT01162421|144522780|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|1.95||0.725|TWO_SIDED|95.0|-4.6|3.2||P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and Baseline value as the covariate.|ANCOVA|||Month 12||3.2|-4.6|0.725
72496596|NCT01162421|144522780|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|2.31||0.837|TWO_SIDED|95.0|-5.1|4.1||P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and Baseline value as the covariate.|ANCOVA|||Month 18||4.1|-5.1|0.837
72496597|NCT01162421|144522780|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|1.83||0.661|TWO_SIDED|95.0|-4.5|2.9||P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and Baseline value as the covariate.|ANCOVA|||Month 24||2.9|-4.5|0.661
72559819|NCT01942135|144650103|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.2||||0.365|TWO_SIDED|95.0|-1.4|3.8||The priori threshold for statistical significance is 2-sided alpha=0.05. The p-value was not adjusted for multiple comparisons.|Mixed Model Analysis (2-sided)|Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.||Statistical significance for palbociclib plus fulvestrant vs placebo plus fulvestrant for cognitive functioning||3.8|-1.4|0.3650
72442887|NCT03899961|144398626|SUPERIORITY|Median regression model for the change from baseline, model was adjusted for treatment, bootstrap was used for the confidence interval|Median Difference (Net)|0.0||||0.05|TWO_SIDED|95.0|-1.09|1.09||Median regression model for the change from baseline, model was adjusted for treatment, bootstrap was used for the confidence interval|Median regression model for the change f|||Median regression model for the change from baseline, model was adjusted for treatment, bootstrap was used for the confidence interval||1.09|-1.09|0.05
72442888|NCT05656911|144398630|OTHER|Bayesian analysis according to estimand|Mean Difference (Final Values)|-5.0|||||TWO_SIDED|95.0|-29.0|18.0|||||Posterior probability is 34.0%|Median of posterior distribution of difference between Zabedosertib and Placebo including credible interval. Posterior probability is presented that the responder rate after treatment with zabedosertib is higher than after placebo given the data observed in the study.||18.0|-29.0|
72496598|NCT01162421|144522781|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.9|STANDARD_ERROR_OF_MEAN|1.29||0.156|TWO_SIDED|95.0|-4.4|0.7||P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and Baseline value as the covariate.|ANCOVA|||Month 3||0.7|-4.4|0.156
72496599|NCT01162421|144522781|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.0|STANDARD_ERROR_OF_MEAN|1.08|<|0.001|TWO_SIDED|95.0|-6.1|-1.9||P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and Baseline value as the covariate.|ANCOVA|The a priori threshold for statistical significance is P=0.001.||Month 6||-1.9|-6.1|<0.001
72619133|NCT01550965|144769017|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.06|||<|0.001|TWO_SIDED|95.0|-4.37|-3.76|||Paired t-test, 2 sided|||Statistical analysis for mean change in total SCCAI from week 0 to week 8.||-3.76|-4.37|<0.001
72619134|NCT01550965|144769017|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.01|||<|0.001|TWO_SIDED|95.0|-3.36|-2.66|||Paired t-test, 2 sided|||Statistical analysis for mean change in total SCCAI from week 0 to week 18. Efficacy assessments were not specified at week 18; missing data at week 18 were imputed using LOCF.||-2.66|-3.36|<0.001
72442889|NCT05656911|144398631|OTHER||Mean Difference (Final Values)|11.31||||0.257|TWO_SIDED|95.0|-8.26|30.87||two-sided. No adjustment for multiple comparisons.|ANCOVA||LS mean (%)|The analysis of covariance (ANCOVA) model includes treatment group as fixed effect and the EASI baseline value as covariate.||30.87|-8.26|0.257
72442890|NCT05656911|144398632|OTHER|Bayesian analysis according to estimand|Mean Difference (Final Values)|-2.7|||||TWO_SIDED|95.0|-27.0|22.1|||||Posterior probability is 41.7%|Median of posterior distribution of difference between Zabedosertib and Placebo including credible interval. Posterior probability is presented that the responder rate after treatment with zabedosertib is higher than after placebo given the data observed in the study.||22.1|-27.0|
72442891|NCT05656911|144398633|OTHER|Bayesian analysis according to estimand|Mean Difference (Final Values)|-4.6|||||TWO_SIDED|95.0|-25.6|13.4|||||Posterior probability is 31.5%|Median of posterior distribution of difference between Zabedosertib and Placebo including credible interval. Posterior probability is presented that the responder rate after treatment with zabedosertib is higher than after placebo given the data observed in the study.||13.4|-25.6|
72496600|NCT01162421|144522781|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.5|STANDARD_ERROR_OF_MEAN|1.19||0.04|TWO_SIDED|95.0|-4.9|-0.1||P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and Baseline value as the covariate.|ANCOVA|The a priori threshold for statistical significance is P=0.05.||Month 9||-0.1|-4.9|0.040
72496601|NCT01162421|144522781|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|1.14||0.492|TWO_SIDED|95.0|-3.1|1.5||P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and Baseline value as the covariate.|ANCOVA|||Month 12||1.5|-3.1|0.492
72496602|NCT01162421|144522781|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|1.3||0.649|TWO_SIDED|95.0|-3.2|2.0||P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and Baseline value as the covariate.|ANCOVA|||Month 18||2.0|-3.2|0.649
72496603|NCT01162421|144522781|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|1.11||0.464|TWO_SIDED|95.0|-3.0|1.4||P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and Baseline value as the covariate.|ANCOVA|||Month 24||1.4|-3.0|0.464
72496604|NCT01162421|144522782|SUPERIORITY_OR_OTHER||LS Mean Difference|-12.3|STANDARD_ERROR_OF_MEAN|5.08||0.018|TWO_SIDED|95.0|-22.5|-2.2||P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and Baseline value as the covariate.|ANCOVA|The a priori threshold for statistical significance is P=0.05.||Month 3||-2.2|-22.5|0.018
72442892|NCT05656911|144398634|OTHER|Bayesian analysis according to estimand|Mean Difference (Final Values)|-12.5|||||TWO_SIDED|95.0|-34.1|7.0|||||Posterior probability is 10.8%|Median of posterior distribution of difference between Zabedosertib and Placebo including credible interval. Posterior probability is presented that the responder rate after treatment with zabedosertib is higher than after placebo given the data observed in the study.||7.0|-34.1|
72442893|NCT05656911|144398635|OTHER||Mean Difference (Final Values)|7.06||||0.166|TWO_SIDED|95.0|-2.92|17.03||two-sided. No adjustment for multiple comparisons.|ANCOVA|||The analysis of covariance (ANCOVA) model includes treatment group as fixed effect and the EASI baseline value as covariate.||17.03|-2.92|0.166
72442894|NCT05656911|144398636|OTHER|Bayesian analysis according to estimand|Mean Difference (Final Values)|-8.4|||||TWO_SIDED|95.0|-30.4|11.0|||||Posterior probability is 20.5%|Median of posterior distribution of difference between Zabedosertib and Placebo including credible interval. Posterior probability is presented that the responder rate after treatment with zabedosertib is higher than after placebo given the data observed in the study.||11.0|-30.4|
72442895|NCT05656911|144398638|OTHER||Mean Difference (Final Values)|6.68||||0.396|TWO_SIDED|95.0|-8.75|22.11||two-sided. No adjustment for multiple comparisons.|ANCOVA|||The analysis of covariance (ANCOVA) model includes treatment group as fixed effect and the EASI baseline value as covariate.||22.11|-8.75|0.396
72442896|NCT05107401|144398652|SUPERIORITY||Mean Difference (Final Values)|-2.3||||0.083|TWO_SIDED|95.0|-4.9|0.3|||Mixed Models Analysis||The statistical values presented are the Estimated Value of Mean Difference between study arms from baseline to the three-month follow-up.|Separate multilevel linear mixed models were calculated for the overall stigma score and then for each of the stigma subscale scores. The multilevel linear mixed models incorporated fixed effects for time (categorical), study arm, and their interaction and included intercept as a random effect. Models were also adjusted for pre-intervention stigma levels, whether the participant had submitted content to the study contest, prior HIV testing, age, sex at birth, and sexual orientation.||0.30|-4.90|0.083
72442897|NCT05107401|144398653|SUPERIORITY||Mean Difference (Final Values)|-0.67||||0.032|TWO_SIDED|95.0|-1.16|-0.18|||Mixed Models Analysis||The statistical values presented are the Estimated Value of Mean Difference between study arms from baseline to the three-month follow-up.|Separate multilevel linear mixed models were calculated for the overall stigma score and then for each of the stigma subscale scores. The multilevel linear mixed models incorporated random fixed effects for time (categorical), study arm, and their interaction and included intercept as a random effect. Models were also adjusted for pre-intervention stigma levels, whether the participant had submitted content to the study contest, age, sex at birth, and sexual orientation.||-0.18|-1.16|0.032
72559820|NCT01942135|144650103|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.1||||0.9615|TWO_SIDED|95.0|-3.4|3.5||The priori threshold for statistical significance is 2-sided alpha=0.05. The p-value was not adjusted for multiple comparisons.|Mixed Model Analysis (2-sided)|Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.||Statistical significance for palbociclib plus fulvestrant vs placebo plus fulvestrant for social functioning||3.5|-3.4|0.9615
72442898|NCT05107401|144398654|SUPERIORITY||Mean Difference (Final Values)|-0.21||||0.48|TWO_SIDED|95.0|-0.72|0.29|||Mixed Models Analysis||The statistical values presented are the Estimated Value of Mean Difference between study arms from baseline to the three-month follow-up.|Separate multilevel linear mixed models were calculated for the overall stigma score and then for each of the stigma subscale scores. The multilevel linear mixed models incorporated random fixed effects for time (categorical), study arm, and their interaction and included intercept as a random effect. Models were also adjusted for pre-intervention stigma levels, whether the participant had submitted content to the study contest, prior HIV testing, age, sex at birth, and sexual orientation.||0.29|-0.72|0.48
72442899|NCT05107401|144398655|SUPERIORITY||Mean Difference (Final Values)|-0.39||||0.48|TWO_SIDED|95.0|-1.49|0.29|||Mixed Models Analysis||The statistical values presented are the Estimated Value of Mean Difference between study arms from baseline to the three-month follow-up.|Separate multilevel linear mixed models were calculated for the overall stigma score and then for each of the stigma subscale scores. The multilevel linear mixed models incorporated random fixed effects for time (categorical), study arm, and their interaction and included intercept as a random effect. Models were also adjusted for pre-intervention stigma levels, whether the participant had submitted content to the study contest, prior HIV testing, age, sex at birth, and sexual orientation.||0.29|-1.49|0.48
72442900|NCT05107401|144398656|SUPERIORITY||Mean Difference (Final Values)|-1.05||||0.37|TWO_SIDED|95.0|-2.6|0.51|||Mixed Models Analysis||The statistical values presented are the Estimated Value of Mean Difference between study arms from baseline to the three-month follow-up.|Separate multilevel linear mixed models were calculated for the overall stigma score and then for each of the stigma subscale scores. The multilevel linear mixed models incorporated random fixed effects for time (categorical), study arm, and their interaction and included intercept as a random effect. Models were also adjusted for pre-intervention stigma levels, whether the participant had submitted content to the study contest, prior HIV testing, age, sex at birth, and sexual orientation.||0.51|-2.60|0.37
72442901|NCT05107401|144398657|SUPERIORITY||Risk Ratio (RR)|1.13||||0.099|TWO_SIDED|95.0|0.98|1.32|||Regression, Logistic||The statistical values presented are the relative risk between study arms at the three-month follow-up.|We used a generalized linear model using a binomial distribution to examine whether the intervention was associated with increased HIV self-testing uptake in the follow-up period. The model was adjusted for history of HIV testing (pre-intervention testing and testing prior to the study), whether the participant had submitted content to the JasSpark contest, and if the participant had a main intimate partner (e.g., girlfriend/boyfriend, spouse).||1.32|0.98|0.099
72496605|NCT01162421|144522782|SUPERIORITY_OR_OTHER||LS Mean Difference|-25.5|STANDARD_ERROR_OF_MEAN|5.9|<|0.001|TWO_SIDED|95.0|-37.3|-13.7||P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and Baseline value as the covariate.|ANCOVA|The a priori threshold for statistical significance is P=0.001.||Month 6||-13.7|-37.3|<0.001
72442902|NCT05107401|144398658|SUPERIORITY||Mean Difference (Final Values)|-5.09||||0.012|TWO_SIDED|95.0|-8.59|-1.58||To account for multiple comparisons arising from analyses of moderating effects, the false discovery rate (FDR) was controlled using Benjamini-Hochberg procedures in a tiered approach.|Mixed Models Analysis||The statistical values presented are the Estimated Value of Mean Difference in females between study arms from baseline to the three-month follow-up.|Sex was marginally significant in the initial multilevel mixed models, therefore, we examined potential moderation effects of sex on stigma changes. Fixed effects corresponding to the two-way interactions involving sex, time, and/or arm, as well as the three-way interaction of sex, time, and arm, were added to the models.||-1.58|-8.59|0.012
72442903|NCT05107401|144398658|SUPERIORITY||Mean Difference (Final Values)|1.58||||0.56|TWO_SIDED|95.0|-2.26|5.42||To account for multiple comparisons arising from analyses of moderating effects, the false discovery rate (FDR) was controlled using Benjamini-Hochberg procedures in a tiered approach.|Mixed Models Analysis||The statistical values presented are the Estimated Value of Mean Difference in males between study arms from baseline to the three-month follow-up.|Sex was marginally significant in the initial multilevel mixed models, therefore, we examined potential moderation effects of sex on stigma changes. Fixed effects corresponding to the two-way interactions involving sex, time, and/or arm, as well as the three-way interaction of sex, time, and arm, were added to the models.||5.42|-2.26|0.56
72442904|NCT01704079|144398807|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
72496606|NCT01162421|144522782|SUPERIORITY_OR_OTHER||LS Mean Difference|-9.4|STANDARD_ERROR_OF_MEAN|5.84||0.113|TWO_SIDED|95.0|-21.0|2.3||P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and Baseline value as the covariate.|ANCOVA|||Month 9||2.3|-21.0|0.113
72496607|NCT01162421|144522782|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.5|STANDARD_ERROR_OF_MEAN|5.72||0.544|TWO_SIDED|95.0|-14.9|7.9||P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and Baseline value as the covariate.|ANCOVA|||Month 12||7.9|-14.9|0.544
72496608|NCT01162421|144522782|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|5.96||0.916|TWO_SIDED|95.0|-12.5|11.2||P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and Baseline value as the covariate.|ANCOVA|||Month 18||11.2|-12.5|0.916
72496609|NCT01162421|144522782|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|5.86||0.983|TWO_SIDED|95.0|-11.8|11.6||P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and Baseline value as the covariate.|ANCOVA|||Month 24||11.6|-11.8|0.983
72496610|NCT01162421|144522783|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.3|STANDARD_ERROR_OF_MEAN|4.96||0.641|TWO_SIDED|95.0|-12.2|7.6||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 3||7.6|-12.2|0.641
72496611|NCT01162421|144522783|SUPERIORITY_OR_OTHER||LS Mean Difference|-5.2|STANDARD_ERROR_OF_MEAN|5.61||0.358|TWO_SIDED|95.0|-16.4|6.0||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 6||6.0|-16.4|0.358
72559821|NCT01942135|144650104|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.5||||0.32|TWO_SIDED|95.0|-4.5|1.5||The priori threshold for statistical significance is 2-sided alpha=0.05. The p-value was not adjusted for multiple comparisons.|Mixed Model Analysis (2-sided)|Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.||Statistical significance for palbociclib plus fulvestrant vs placebo plus fulvestrant for fatigue||1.5|-4.5|0.3200
72559822|NCT01942135|144650104|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.5||||0.0369|TWO_SIDED|95.0|-4.8|-0.2||The priori threshold for statistical significance is 2-sided alpha=0.05. The p-value was not adjusted for multiple comparisons.|Mixed Model Analysis (2-sided)|Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.||Statistical significance for palbociclib plus fulvestrant vs placebo plus fulvestrant for nausea and vomiting||-0.2|-4.8|0.0369
72619135|NCT01550965|144769017|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.07|||<|0.001|TWO_SIDED|95.0|-4.43|-3.72|||Paired t-test, 2 sided|||Statistical analysis for mean change in total SCCAI from week 0 to week 26.||-3.72|-4.43|<0.001
72442905|NCT01704079|144398808|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
72442906|NCT01704079|144398809|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
72442907|NCT01704079|144398810|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
72442908|NCT04500301|144398846|OTHER|No statistical test was performed.|Proportion|0.136|||||TWO_SIDED|95.0|0.054|0.219|||||The Wald 95% confidence interval for the binomial proportion was estimated.|No hypothesis was tested with regard to the primary outcome. The study planned to enroll 80 eligible subjects such that at least 65 would be evaluable for the primary outcome and the width of the 95% Clopper-Pearson confidence interval for the proportion would be less than or equal to .25.||0.219|0.054|
72496612|NCT01162421|144522783|SUPERIORITY_OR_OTHER||LS Mean Difference|5.2|STANDARD_ERROR_OF_MEAN|5.58||0.352|TWO_SIDED|95.0|-5.9|16.4||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 9||16.4|-5.9|0.352
72496613|NCT01162421|144522783|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|5.28||0.99|TWO_SIDED|95.0|-10.5|10.6||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 12||10.6|-10.5|0.990
72496614|NCT01162421|144522783|SUPERIORITY_OR_OTHER||LS Mean Difference|6.4|STANDARD_ERROR_OF_MEAN|5.36||0.238|TWO_SIDED|95.0|-4.3|17.1||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 18||17.1|-4.3|0.238
72496615|NCT01162421|144522783|SUPERIORITY_OR_OTHER||LS Mean Difference|7.1|STANDARD_ERROR_OF_MEAN|5.54||0.207|TWO_SIDED|95.0|-4.0|18.1||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 24||18.1|-4.0|0.207
72619136|NCT01550965|144769018|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1|||<|0.001|TWO_SIDED|95.0|0.08|0.11|||Paired t-test, 2 sided|||Statistical analysis for mean change in total EQ-5D-5L total score from week 0 to week 2.||0.11|0.08|<0.001
72442909|NCT02058108|144398858|OTHER|Missing assessment imputed using the closest available assessment|Mean Difference (Net)|-0.3||||1|TWO_SIDED|95.0|-37.03|36.75|||Fisher Exact|||HBV DNA level of \<300 copies/mL (51 IU/mL) at Week 24|Exact confidence interval for the difference in percentage|36.75|-37.03|1.0000
72442910|NCT02058108|144398860|OTHER||Mean Difference (Net)|32.43||||0.2984|TWO_SIDED|95.0|-14.62|74.6|||Fisher Exact||Exact confidence interval for the difference in percentage. P-value from Fishers exact test comparing proportions in Initial LdT and Initial Placebo groups.|ALT levels at Week 24||74.60|-14.62|0.2984
72442911|NCT02058108|144398861|OTHER||Mean Difference (Net)|2.7||||1|TWO_SIDED|95.0|-53.7|60.2|||Fisher Exact||Exact confidence interval for the difference in percentage. P-value from Fishers exact test comparing proportions in Initial LdT and Initial Placebo groups.|HBeAg loss at Week 24||60.20|-53.70|1.0000
72442912|NCT02058108|144398861|OTHER||Mean Difference (Net)|2.7||||1|TWO_SIDED|95.0|-53.7|60.2|||Fisher Exact||Exact confidence interval for the difference in percentage. P-value from Fishers exact test comparing proportions in Initial LdT and Initial Placebo groups.|HBeAg seroconversion at Week 24||60.20|-53.70|1.0000
72442913|NCT02058108|144398862|OTHER||Mean Difference (Net)|2.44||||1|TWO_SIDED|95.0|-37.54|42.17|||Fisher Exact||Exact confidence interval for the difference in percentage. P-value from Fishers exact test comparing proportions in Initial LdT and Initial Placebo groups.|HBsAg loss at Week 24||42.17|-37.54|1.0000
72442914|NCT02058108|144398865|OTHER||Mean Difference (Net)|2.5||||1|TWO_SIDED|95.0|-37.05|41.83|||Fisher Exact||Exact confidence interval for the difference in percentage. P-value from Fishers exact test comparing proportions in Initial LdT and Initial Placebo groups.|Treatment emergent genotypic resistance at Week 24||41.83|-37.05|1.0000
72496616|NCT01162421|144522784|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|5.28||0.85|TWO_SIDED|95.0|-11.5|9.5||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 3||9.5|-11.5|0.850
72496617|NCT01162421|144522784|SUPERIORITY_OR_OTHER||LS Mean Difference|-8.4|STANDARD_ERROR_OF_MEAN|5.49||0.129|TWO_SIDED|95.0|-19.4|2.5||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 6||2.5|-19.4|0.129
72496618|NCT01162421|144522784|SUPERIORITY_OR_OTHER||LS Mean Difference|0.4|STANDARD_ERROR_OF_MEAN|5.62||0.937|TWO_SIDED|95.0|-10.8|11.6||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 9||11.6|-10.8|0.937
72496619|NCT01162421|144522784|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.4|STANDARD_ERROR_OF_MEAN|5.59||0.67|TWO_SIDED|95.0|-13.5|8.8||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 12||8.8|-13.5|0.670
72496620|NCT01162421|144522784|SUPERIORITY_OR_OTHER||LS Mean Difference|5.4|STANDARD_ERROR_OF_MEAN|5.67||0.341|TWO_SIDED|95.0|-5.9|16.7||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 18||16.7|-5.9|0.341
72496621|NCT01162421|144522784|SUPERIORITY_OR_OTHER||LS Mean Difference|3.0|STANDARD_ERROR_OF_MEAN|6.13||0.621|TWO_SIDED|95.0|-9.2|15.3||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 24||15.3|-9.2|0.621
72619137|NCT01550965|144769018|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.13|||<|0.001|TWO_SIDED|95.0|0.11|0.15|||Paired t-test, 2 sided|||Statistical analysis for mean change in total EQ-5D-5L total score from week 0 to week 8.||0.15|0.11|<0.001
72442915|NCT00818246|144398898|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.94|STANDARD_ERROR_OF_MEAN|2.68|<|0.0001|||||||ANCOVA|analysis of covariance (ANCOVA) was used to assess statistical differences between the LED-treated and untreated sides taking into account Age.||Sample sizes and power calculations were generated according to the primary outcome measures of the study. In order to have a 98% chance of detecting as significant (at the two sided 5% level) a 10% difference between the treated and untreated/control sides in the Ra and Rz post-treatment improvement, with an assumed standard deviation of 10, 33 subjects were required. To account for an 80% per protocol completion rate, the planned number of patients to be enrolled was 40.||||<0.0001
72442916|NCT00818246|144398899|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.605|STANDARD_ERROR_OF_MEAN|0.09|<|0.001|||||||ANCOVA|||||||<0.001
72442917|NCT00818246|144398900|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.4|STANDARD_ERROR_OF_MEAN|2.8|<|0.0001|||||||ANCOVA|analysis of covariance (ANCOVA) was used to assess statistical differences between the LED-treated and untreated sides taking into account Age.||Sample sizes and power calculations were generated according to the primary outcome measures of the study. In order to have a 98% chance of detecting as significant (at the two sided 5% level) a 10% difference between the treated and untreated/control sides in the Ra and Rz post-treatment improvement, with an assumed standard deviation of 10, 33 subjects were required. To account for an 80% per protocol completion rate, the planned number of patients to be enrolled was 40.||||<0.0001
72442918|NCT01619410|144398937|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.0
72442919|NCT02885636|144398947|SUPERIORITY|||||||0.003|||||||ANCOVA|||||||0.003
72442920|NCT02885636|144398948|SUPERIORITY|||||||0.3|||||||t-test, 2 sided|||||||0.3
72442921|NCT02885636|144398949|SUPERIORITY|||||||0.7|||||||t-test, 2 sided|||||||0.7
72442922|NCT02885636|144398950|SUPERIORITY|||||||0.9|||||||t-test, 2 sided|||||||0.9
72442923|NCT02885636|144398951|SUPERIORITY|||||||0.001|||||||t-test, 2 sided|||||||0.001
72442924|NCT02885636|144398952|SUPERIORITY|||||||0.2|||||||t-test, 2 sided|||||||0.2
72442925|NCT02885636|144398953|SUPERIORITY|||||||0.0002|||||||t-test, 2 sided|||||||0.0002
72442926|NCT02885636|144398954|SUPERIORITY|||||||0.08|||||||t-test, 2 sided|||||||0.08
72442927|NCT02885636|144398955|SUPERIORITY|||||||0.0007|||||||t-test, 2 sided|||||||0.0007
72442928|NCT02885636|144398956|SUPERIORITY|||||||0.03|||||||t-test, 2 sided|||||||0.03
72442929|NCT02885636|144398957|SUPERIORITY|||||||0.004|||||||t-test, 2 sided|||||||0.004
72442930|NCT02885636|144398958|SUPERIORITY|||||||0.7|||||||t-test, 2 sided|||||||0.7
72442931|NCT02885636|144398959|SUPERIORITY|||||||0.004|||||||t-test, 2 sided|||||||0.004
72442932|NCT02885636|144398960|SUPERIORITY|||||||0.09|||||||t-test, 2 sided|||||||0.09
72442933|NCT02538341|144398961|OTHER|||||||0.0023||||||p values, from a generalized linear model on the rank order of the week 6 - baseline change using normal distribution and reciprocal link.|a generalized linear model|p value,from a generalized linear model on the rank order of the week 6 - baseline change using normal distribution and reciprocal link.||Study protocol defined measure for immunogenicity samples. Participants must have at least 1 post vaccine immunogenicity measure to determine the GMFR (a priori analysis)||||0.0023
72496622|NCT01162421|144522785|SUPERIORITY_OR_OTHER||LS Mean Difference|1.3|STANDARD_ERROR_OF_MEAN|3.29||0.697|TWO_SIDED|95.0|-5.3|7.9||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 3||7.9|-5.3|0.697
72496623|NCT01162421|144522785|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.5|STANDARD_ERROR_OF_MEAN|4.51||0.744|TWO_SIDED|95.0|-10.5|7.5||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 6||7.5|-10.5|0.744
72496624|NCT01162421|144522785|SUPERIORITY_OR_OTHER||LS Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|3.95||0.967|TWO_SIDED|95.0|-7.7|8.0||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 9||8.0|-7.7|0.967
72496625|NCT01162421|144522785|SUPERIORITY_OR_OTHER||LS Mean Difference|2.9|STANDARD_ERROR_OF_MEAN|3.3||0.377|TWO_SIDED|95.0|-3.7|9.5||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 12||9.5|-3.7|0.377
72496626|NCT01162421|144522785|SUPERIORITY_OR_OTHER||LS Mean Difference|5.5|STANDARD_ERROR_OF_MEAN|3.5||0.122|TWO_SIDED|95.0|-1.5|12.4||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 18||12.4|-1.5|0.122
72496627|NCT01162421|144522785|SUPERIORITY_OR_OTHER||LS Mean Difference|2.4|STANDARD_ERROR_OF_MEAN|3.42||0.49|TWO_SIDED|95.0|-4.4|9.2||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 24||9.2|-4.4|0.490
72442934|NCT02538341|144398962|OTHER|||||||0.31||||||p values, from a generalized linear model on the rank order of the week 6 - baseline change using normal distribution and reciprocal link.|a generalized linear model|p values, from a generalized linear model on the rank order of the week 6 - baseline change using normal distribution and reciprocal link.||Study protocol defined measure for immunogenicity samples. Participants must have at least 1 post vaccine immunogenicity measure to determine the GMFR (a priori analysis)||||0.31
72496628|NCT01162421|144522786|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.27||0.102|TWO_SIDED|95.0|-1.0|0.1||P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and Baseline value as the covariate.|ANCOVA|||Month 3||0.1|-1.0|0.102
72496629|NCT01162421|144522786|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|0.29||0.003|TWO_SIDED|95.0|-1.5|-0.3||P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and Baseline value as the covariate.|ANCOVA|The a priori threshold for statistical significance is P=0.01.||Month 6||-0.3|-1.5|0.003
72496630|NCT01162421|144522786|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.29||0.214|TWO_SIDED|95.0|-0.9|0.2||P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and Baseline value as the covariate.|ANCOVA|||Month 9||0.2|-0.9|0.214
72496631|NCT01162421|144522786|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.27||0.339|TWO_SIDED|95.0|-0.8|0.3||P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and Baseline value as the covariate.|ANCOVA|||Month 12||0.3|-0.8|0.339
72496632|NCT01162421|144522786|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.3||0.973|TWO_SIDED|95.0|-0.6|0.6||P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and Baseline value as the covariate.|ANCOVA|||Month 18||0.6|-0.6|0.973
72496633|NCT01162421|144522786|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.28||0.755|TWO_SIDED|95.0|-0.6|0.5||P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and Baseline value as the covariate.|ANCOVA|||Month 24||0.5|-0.6|0.755
72559823|NCT01942135|144650104|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.3||||0.0011|TWO_SIDED|95.0|-8.5|-2.1||The priori threshold for statistical significance is 2-sided alpha=0.05. The p-value was not adjusted for multiple comparisons.|Mixed Model Analysis (2-sided)|Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.||Statistical significance for palbociclib plus fulvestrant vs placebo plus fulvestrant for pain||-2.1|-8.5|0.0011
72496634|NCT01162421|144522787|SUPERIORITY_OR_OTHER||Difference in percentage|9.4||||0.316|TWO_SIDED|95.0|-7.09|25.13|||Fisher Exact|Two-sided Fisher Exact test.||Month 3||25.13|-7.09|0.316
72496635|NCT01162421|144522787|SUPERIORITY_OR_OTHER||Difference in percentage|24.5||||0.014|TWO_SIDED|95.0|6.09|42.85|||Chi-squared|P-value is based on two-sided Pearson's chi-square test. The a priori threshold for statistical significance is P=0.05.||Month 6||42.85|6.09|0.014
72559824|NCT01942135|144650104|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.5||||0.7699|TWO_SIDED|95.0|-3.7|2.8||The priori threshold for statistical significance is 2-sided alpha=0.05. The p-value was not adjusted for multiple comparisons.|Mixed Model Analysis (2-sided)|Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.||Statistical significance for palbociclib plus fulvestrant vs placebo plus fulvestrant for dyspnoea||2.8|-3.7|0.7699
72496636|NCT01162421|144522787|SUPERIORITY_OR_OTHER||Difference in percentage|-3.2||||0.762|TWO_SIDED|95.0|-24.1|17.66|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 9||17.66|-24.10|0.762
72442935|NCT04402294|144398968|OTHER|Parametric inferential statistical test|Group mean difference|0.71||||0.5|TWO_SIDED|||||The threshold for statistical significance was set to p = 0.05|ANOVA|||ANOVA (Optimal vs Suboptimal vs No Stimulation)||||0.50
72442936|NCT04402294|144398969|OTHER|Parametric inferential statistical test|Group mean difference|0.03||||0.975|TWO_SIDED|||||The threshold for statistical significance was set to p = 0.05|ANOVA|||ANOVA (Optimal vs Suboptimal vs No Stimulation)||||0.975
72559825|NCT01942135|144650104|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.0||||0.2721|TWO_SIDED|95.0|-5.5|1.6||The priori threshold for statistical significance is 2-sided alpha=0.05. The p-value was not adjusted for multiple comparisons.|Mixed Model Analysis (2-sided)|Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.||Statistical significance for palbociclib plus fulvestrant vs placebo plus fulvestrant for insomnia||1.6|-5.5|0.2721
72442937|NCT04402294|144398970|OTHER|Parametric inferential statistical test|Group mean difference|2.05||||0.097|TWO_SIDED|||||The threshold for statistical significance was p = 0.05|ANOVA|||ANOVA, with neuromodulation stimulation type (optimal vs. suboptimal), stimulation days (1 to 3), and delay (0, 4, or 12 seconds) as within-subject variables.||||0.097
72442938|NCT04402294|144398971|OTHER|Parametric Inferential Statistical Test|Group mean difference|0.63||||0.644|TWO_SIDED|||||The threshold for statistical significance was 0.05|ANOVA|||ANOVA, with neuromodulation stimulation type (optimal vs. suboptimal), stimulation days (1 to 3), and delay (0, 4, or 12 seconds) as within-subject variables.||||0.644
72442939|NCT04402294|144398972|OTHER|Parametric inferential statistical test|Group mean difference|0.84||||0.439|TWO_SIDED|||||The threshold for statistical significance was p = 0.05|ANOVA|||ANOVA, with neuromodulation stimulation type (optimal vs. suboptimal), and stimulation days (1 to 3) as within-subject variables.||||0.439
72442940|NCT04402294|144398973|OTHER|Parametric inferential statistical test|Group mean difference|0.59||||0.563|TWO_SIDED|||||The threshold for statistical significance was p = 0.05|ANOVA|||Optimal Neuromodulation Day-1, Optimal Neuromodulation Day-2, Optimal Neuromodulation Day-3, Suboptimal Neuromodulation Day-1, Suboptimal Neuromodulation Day-2, Suboptimal Neuromodulation Day-3||||0.563
72442941|NCT03481660|144398974|NON_INFERIORITY|(4-letter margin) (1-sided)|LS mean difference|1.2|STANDARD_ERROR_OF_MEAN|0.94|<|0.001|TWO_SIDED|95.0|-0.6|3.1|||ANOVA|||BCVA at Week 52||3.1|-0.6|<0.001
72496637|NCT01162421|144522787|SUPERIORITY_OR_OTHER||Difference in percentage|13.0||||0.22|TWO_SIDED|95.0|-7.46|33.54|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 12||33.54|-7.46|0.220
72496638|NCT01162421|144522787|SUPERIORITY_OR_OTHER||Difference in percentage|-3.5||||0.747|TWO_SIDED|95.0|-24.9|17.86|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 18||17.86|-24.90|0.747
72496639|NCT01162421|144522787|SUPERIORITY_OR_OTHER||Difference in percentage|-4.4||||0.701|TWO_SIDED|95.0|-26.8|18.01|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 24||18.01|-26.80|0.701
72496640|NCT01162421|144522788|SUPERIORITY_OR_OTHER||Difference in percentage|10.5||||0.318|TWO_SIDED|95.0|-9.83|30.78|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 3||30.78|-9.83|0.318
72496641|NCT01162421|144522788|SUPERIORITY_OR_OTHER||Difference in percentage|22.7||||0.047|TWO_SIDED|95.0|1.03|44.39|||Chi-squared|P-value is based on two-sided Pearson's chi-square test. The a priori threshold for statistical significance is P=0.05.||Month 6||44.39|1.03|0.047
72559826|NCT01942135|144650104|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.6||||0.7334|TWO_SIDED|95.0|-4.1|2.9||The priori threshold for statistical significance is 2-sided alpha=0.05. The p-value was not adjusted for multiple comparisons.|Mixed Model Analysis (2-sided)|Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.||Statistical significance for palbociclib plus fulvestrant vs placebo plus fulvestrant for appetite loss||2.9|-4.1|0.7334
72559827|NCT01942135|144650104|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.7||||0.6491|TWO_SIDED|95.0|-2.5|3.9||The priori threshold for statistical significance is 2-sided alpha=0.05. The p-value was not adjusted for multiple comparisons.|Mixed Model Analysis (2-sided)|Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.||Statistical significance for palbociclib plus fulvestrant vs placebo plus fulvestrant for constipation||3.9|-2.5|0.6491
72442942|NCT03481660|144398975|NON_INFERIORITY|(4-letter margin) (1-sided)|LS mean difference|0.9|STANDARD_ERROR_OF_MEAN|0.88|<|0.001|TWO_SIDED|95.0|-0.9|2.6|||ANOVA|||BCVA over period Week 40 through Week 52||2.6|-0.9|<0.001
72442943|NCT03481660|144398975|SUPERIORITY|||||||0.164|||||||ANOVA|||BCVA over period Week 40 through Week 52||||0.164
72442944|NCT03481660|144398982|OTHER|Treatment Difference|LS mean difference|1.2|STANDARD_ERROR_OF_MEAN|0.94|||TWO_SIDED|95.0|-0.6|3.1||||||BCVA at Week 52||3.1|-0.6|
72442945|NCT03481660|144398982|OTHER|Treatment Difference|LS mean difference|2.6|STANDARD_ERROR_OF_MEAN|1.21|||TWO_SIDED|95.0|0.2|4.9||||||BCVA at Week 100||4.9|0.2|
72442946|NCT03481660|144398983|OTHER|Treatment difference|LS mean difference|0.8|STANDARD_ERROR_OF_MEAN|0.7|||TWO_SIDED|95.0|-0.6|2.1||||||BCVA over period Week 4 through Week 52||2.1|-0.6|
72442947|NCT03481660|144398983|OTHER|Treatment difference|LS mean difference|1.1|STANDARD_ERROR_OF_MEAN|0.78|||TWO_SIDED|95.0|-0.4|2.6||||||BCVA over period Week 4 through Week 100||2.6|-0.4|
72442948|NCT03481660|144398984|OTHER|Treatment difference|LS mean difference|0.8|STANDARD_ERROR_OF_MEAN|0.83|||TWO_SIDED|95.0|-0.9|2.4||||||BCVA over period Week 20 through Week 52||2.4|-0.9|
72442949|NCT03481660|144398984|OTHER|Treatment difference|LS mean difference|0.8|STANDARD_ERROR_OF_MEAN|0.85|||TWO_SIDED|95.0|-0.9|2.5||||||BCVA over period Week 28 through Week 52||2.5|-0.9|
72442950|NCT03481660|144398984|OTHER|Treatment difference|LS mean difference|1.2|STANDARD_ERROR_OF_MEAN|0.87|||TWO_SIDED|95.0|-0.5|2.9||||||BCVA over period Week 20 through Week 100||2.9|-0.5|
72442951|NCT03481660|144398984|OTHER|Treatment difference|LS mean difference|1.3|STANDARD_ERROR_OF_MEAN|0.89|||TWO_SIDED|95.0|-0.5|3.0||||||BCVA over period Week 28 through Week 100||3.0|-0.5|
72442952|NCT03481660|144398985|OTHER|Treatment difference|LS mean difference|2.1|STANDARD_ERROR_OF_MEAN|1.12|||TWO_SIDED|95.0|-0.1|4.3||||||BCVA over period Week 88 through Week 100||4.3|-0.1|
72442953|NCT03481660|144398986|OTHER|Treatment difference|Clopper-Pearson exact method|0.4|||||TWO_SIDED|95.0|-7.6|8.9||||||Gain of \>= 5 letters in BCVA at Week 52||8.9|-7.6|
72442954|NCT03481660|144398986|OTHER|Treatment difference|Clopper-Pearson exact method|5.4|||||TWO_SIDED|95.0|-3.9|14.5||||||Gain of \>= 5 letters in BCVA at Week 100||14.5|-3.9|
72442955|NCT03481660|144398987|OTHER|Treatment difference|Clopper-Pearson exact method|5.4|||||TWO_SIDED|95.0|-3.9|14.7||||||Gain of \>= 10 letters in BCVA at Week 52||14.7|-3.9|
72442956|NCT03481660|144398987|OTHER|Treatment difference|Clopper-Pearson exact method|9.9|||||TWO_SIDED|95.0|-0.4|19.4||||||Gain of \>= 10 letters in BCVA at Week 100||19.4|-0.4|
72442957|NCT03481660|144398988|OTHER|Treatment difference|Clopper-Pearson exact method|9.6|||||TWO_SIDED|95.0|-0.4|20.2||||||Gain of \>= 15 letters in BCVA at Week 52||20.2|-0.4|
72442958|NCT03481660|144398988|OTHER|Treatment difference|Clopper-Pearson exact method|13.6|||||TWO_SIDED|95.0|3.3|23.5||||||Gain of \>= 15 letters in BCVA at Week 100||23.5|3.3|
72442959|NCT03481660|144398989|OTHER|Treatment difference|Clopper-Pearson exact method|-0.4|||||TWO_SIDED|95.0|-4.2|2.9||||||Loss of \>= 5 letters in BCVA at Week 52||2.9|-4.2|
72442960|NCT03481660|144398989|OTHER|Treatment difference|Clopper-Pearson exact method|-6.0|||||TWO_SIDED|95.0|-10.8|-1.7||||||Loss of \>= 5 letters in BCVA at Week 100||-1.7|-10.8|
72442961|NCT03481660|144398990|OTHER|Treatment difference|Clopper-Pearson exact method|-0.2|||||TWO_SIDED|95.0|-3.2|2.4||||||Loss of \>= 10 letters in BCVA at Week 52||2.4|-3.2|
72442962|NCT03481660|144398990|OTHER|Treatment difference|Clopper-Pearson exact method|-4.1|||||TWO_SIDED|95.0|-8.4|-0.1||||||Loss of \>= 10 letters in BCVA at Week 100||-0.1|-8.4|
72442963|NCT03481660|144398991|OTHER|Treatment difference|Clopper-Pearson exact method|-0.7|||||TWO_SIDED|95.0|-3.2|1.6||||||Loss of \>= 15 letters in BCVA at Week 52||1.6|-3.2|
72496642|NCT01162421|144522788|SUPERIORITY_OR_OTHER||Difference in percentage|5.0||||0.668|TWO_SIDED|95.0|-17.74|27.71|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 9||27.71|-17.74|0.668
72496643|NCT01162421|144522788|SUPERIORITY_OR_OTHER||Difference in percentage|7.8||||0.5|TWO_SIDED|95.0|-14.88|30.56|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 12||30.56|-14.88|0.500
72496644|NCT01162421|144522788|SUPERIORITY_OR_OTHER||Difference in percentage|-2.7||||0.816|TWO_SIDED|95.0|-25.52|20.1|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 18||20.10|-25.52|0.816
72619138|NCT01550965|144769018|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.12|||<|0.001|TWO_SIDED|95.0|0.1|0.14|||Paired t-test, 2 sided|||Statistical analysis for mean change in total EQ-5D-5L total score from week 0 to week 18. Efficacy assessments were not specified at week 18; missing data at week 18 were imputed using LOCF.||0.14|0.10|<0.001
72442964|NCT03481660|144398991|OTHER|Treatment difference|Clopper-Pearson exact method|-1.3|||||TWO_SIDED|95.0|-4.8|2.0||||||Loss of \>= 15 letters in BCVA at Week 100||2.0|-4.8|
72442965|NCT03481660|144398992|OTHER|Treatment difference|Clopper-Pearson exact method|3.5|||||TWO_SIDED|95.0|-4.9|12.0||||||Absolute BCVA \>= 73 letters at Week 52||12.0|-4.9|
72442966|NCT03481660|144398992|OTHER|Treatment difference|Clopper-Pearson exact method|3.6|||||TWO_SIDED|95.0|-5.4|12.6||||||Absolute BCVA \>= 73 letters at Week 100||12.6|-5.4|
72442967|NCT03481660|144398994|OTHER|Treatment difference|LS mean difference|-29.4|STANDARD_ERROR_OF_MEAN|9.76|<|0.003|TWO_SIDED|95.0|-48.6|-10.2|||ANOVA|||CSFT over period Week 40 through Week 52||-10.2|-48.6|<0.003
72442968|NCT03481660|144398994|SUPERIORITY|||||||0.001|||||||ANOVA|||CSFT over period Week 40 through Week 52||||0.001
72442969|NCT03481660|144398994|OTHER|Treatment difference|LS mean difference|-23.2|STANDARD_ERROR_OF_MEAN|10.28|||TWO_SIDED|95.0|-43.5|-3.0||||||CSFT over period Week 88 through Week 100||-3.0|-43.5|
72442970|NCT03481660|144398995|OTHER|Treatment difference|LS mean difference|-27.4|STANDARD_ERROR_OF_MEAN|9.35|||TWO_SIDED|95.0|-45.8|-9.0||||||CSFT over period Week 4 through Week 52||-9.0|-45.8|
72442971|NCT03481660|144398995|OTHER|Treatment difference|LS mean difference|-25.8|STANDARD_ERROR_OF_MEAN|9.29|||TWO_SIDED|95.0|-44.0|-7.5||||||CSFT over period Week 4 through Week 100||-7.5|-44.0|
72442972|NCT03481660|144398996|OTHER|Treatment difference|Clopper-Pearson exact method|16.3|||||TWO_SIDED|95.0|5.7|25.9||||||CSFT thickness (\<280 micrometers) at Week 52||25.9|5.7|
72442973|NCT03481660|144398996|OTHER|Treatment difference|Clopper-Pearson exact method|14.7|||||TWO_SIDED|95.0|4.2|24.9||||||CSFT thickness (\<280 micrometers) at Week 100||24.9|4.2|
72442974|NCT03481660|144398997|OTHER||Clopper-Pearson exact method|-1.2|||||TWO_SIDED|95.0|-4.5|2.1||||||Subretinal Fluid (SRF) at Week 52||2.1|-4.5|
72442975|NCT03481660|144398997|OTHER|Treatment Difference|Clopper-Pearson exact method|-0.2|||||TWO_SIDED|95.0|-3.4|3.4||||||Subretinal Fluid (SRF) at Week 100||3.4|-3.4|
72442976|NCT03481660|144398998|OTHER|Treatment Difference|Clopper-Pearson exact method|-19.1|||||TWO_SIDED|95.0|-28.9|-9.2||||||Intraretinal Fluid (IRF) at Week 52||-9.2|-28.9|
72442977|NCT03481660|144398998|OTHER|Treatment Difference|Clopper-Pearson exact method|-16.1|||||TWO_SIDED|95.0|-26.3|-5.7||||||Intraretinal Fluid (IRF) at Week 100||-5.7|-26.3|
72442978|NCT03481660|144398999|OTHER|Treatment Difference|Clopper-Pearson exact method|-18.4|||||TWO_SIDED|95.0|-28.5|-8.3||||||Subretinal Fluid (SRF) and/or Intraretinal Fluid (IRF) at Week 52||-8.3|-28.5|
72442979|NCT03481660|144398999|OTHER|Treatment difference|Clopper-Pearson exact method|-16.2|||||TWO_SIDED|95.0|-26.4|-5.9||||||Subretinal Fluid (SRF) and/or Intraretinal Fluid (IRF) at Week 100||-5.9|-26.4|
72442980|NCT03481660|144399000|OTHER|Treatment difference|Clopper-Pearson exact method|-25.4|||||TWO_SIDED|95.0|-34.4|-16.3||||||Fluorescein Angiography (FA) at Week 52||-16.3|-34.4|
72442981|NCT03481660|144399000|OTHER|Treatment difference|Clopper-Pearson exact method|-19.1|||||TWO_SIDED|95.0|-29.1|-8.2||||||Fluorescein Angiography (FA) at Week 100||-8.2|-29.1|
72442982|NCT03481660|144399001|OTHER|Treatment difference|Clopper-Pearson exact method|1.1|||||TWO_SIDED|95.0|-5.6|7.8||||||\>=2-step improvement in ETDRS-DRSS at Week 52||7.8|-5.6|
72442983|NCT03481660|144399001|OTHER|Treatment difference|Clopper-Pearson exact method|4.5|||||TWO_SIDED|95.0|-1.7|10.8||||||\>=2-step improvement in ETDRS-DRSS at Week 100||10.8|-1.7|
72442984|NCT03481660|144399002|OTHER|Treatment difference|Clopper-Pearson exact method|-0.6|||||TWO_SIDED|95.0|-7.1|5.7||||||\>=3-step improvement in ETDRS-DRSS at Week 52||5.7|-7.1|
72442985|NCT03481660|144399002|OTHER|Treatment difference|Clopper-Pearson exact method|3.9|||||TWO_SIDED|95.0|-2.3|10.0||||||\>=3-step improvement in ETDRS-DRSS at Week 100||10.0|-2.3|
72442986|NCT03481660|144399003|OTHER|Treatment difference|Clopper-Pearson exact method|1.1|||||TWO_SIDED|95.0|-1.0|3.6||||||\>=2-step worsening in ETDRS-DRSS at Week 52||3.6|-1.0|
72442987|NCT03481660|144399003|OTHER|Treatment difference|Clopper-Pearson exact method|2.9|||||TWO_SIDED|95.0|-0.5|6.9||||||\>=2-step worsening in ETDRS-DRSS at Week 100||6.9|-0.5|
72442988|NCT03481660|144399004|OTHER|Treatment difference|Clopper-Pearson exact method|0.6|||||TWO_SIDED|95.0|0.5|2.1||||||\>=3-step worsening in ETDRS-DRSS at Week 52||2.1|0.5|
72442989|NCT03481660|144399004|OTHER|Treatment difference|Clopper-Pearson exact method|-0.6|||||TWO_SIDED|95.0|-2.6|1.3||||||\>=3-step worsening in ETDRS-DRSS at Week 100||1.3|-2.6|
72442990|NCT03481660|144399005|OTHER|Treatment difference|Clopper-Pearson exact method|0.0|||||TWO_SIDED|95.0|-2.1|1.9||||||Proliferative diabetic retinopathy (PDR) of at least 61 by Week 100||1.9|-2.1|
72559828|NCT01942135|144650104|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.6||||0.6293|TWO_SIDED|95.0|-2.8|1.7||The priori threshold for statistical significance is 2-sided alpha=0.05. The p-value was not adjusted for multiple comparisons.|Mixed Model Analysis (2-sided)|Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.||Statistical significance for palbociclib plus fulvestrant vs placebo plus fulvestrant for diarrhoea||1.7|-2.8|0.6293
72442991|NCT04065048|144399025|OTHER|||||||0.469|||||||t-test, 2 sided|||||||0.469
72442992|NCT04065048|144399026|OTHER|||||||0.0093|||||||ANOVA|||||||0.0093
72442993|NCT04065048|144399028|OTHER|||||||0.2487|||||||Fisher Exact|||||||0.2487
72442994|NCT05307978|144399059|SUPERIORITY||Ratio (%)|68.729|||||TWO_SIDED|95.0|52.74|89.56|||Mixed Models Analysis|A mixed effect model was performed to the ln-transformed PK parameter and the independent variables.||||89.56|52.74|
72442995|NCT05307978|144399060|SUPERIORITY||Ratio (%)|120.043|||||TWO_SIDED|95.0|67.2|214.43|||Mixed Models Analysis|A mixed effect model was performed with ethnicity as fixed effect and participant as random effect.||||214.43|67.20|
72442996|NCT05307978|144399061|SUPERIORITY||Ratio (%)|118.142|||||TWO_SIDED|95.0|73.93|188.8|||Mixed Models Analysis|A mixed effect model was performed with ethnicity as fixed effect and participant as random effect.||||188.80|73.93|
72496645|NCT01162421|144522788|SUPERIORITY_OR_OTHER||Difference in percentage|-10.7||||0.358|TWO_SIDED|95.0|-33.38|11.99|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 24||11.99|-33.38|0.358
72496646|NCT01162421|144522789|SUPERIORITY_OR_OTHER||Difference in percentage|7.9||||0.444|TWO_SIDED|95.0|-12.17|28.0|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 3||28.00|-12.17|0.444
72496647|NCT01162421|144522789|SUPERIORITY_OR_OTHER||Difference in percentage|20.1||||0.076|TWO_SIDED|95.0|-1.53|41.83|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 6||41.83|-1.53|0.076
72496648|NCT01162421|144522789|SUPERIORITY_OR_OTHER||Difference in percentage|2.7||||0.816|TWO_SIDED|95.0|-20.1|25.52|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 9||25.52|-20.10|0.816
72496649|NCT01162421|144522789|SUPERIORITY_OR_OTHER||Difference in percentage|8.1||||0.485|TWO_SIDED|95.0|-14.61|30.87|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 12||30.87|-14.61|0.485
72496650|NCT01162421|144522789|SUPERIORITY_OR_OTHER||Difference in percentage|-2.7||||0.816|TWO_SIDED|95.0|-25.52|20.1|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 18||20.10|-25.52|0.816
72442997|NCT05307978|144399062|SUPERIORITY||Ratio (%)|93.891|||||TWO_SIDED|95.0|63.17|139.56|||Mixed Models Analysis|A mixed effect model was performed with ethnicity as fixed effect and participant as random effect.||||139.56|63.17|
72442998|NCT05075408|144399067|SUPERIORITY|Analysis was performed using hierarchical testing procedure. Testing was then performed sequentially in order the outcome measures were reported and continued when previous outcome measure was statistically significant at two-sided 0.025.|Strata adjusted percentage difference|7.0||||0.3696|TWO_SIDED|97.5|-10.6|24.6||Threshold of significance at 0.025.|Cochran-Mantel-Haenszel|||Nemolizumab 30 mg versus Placebo||24.6|-10.6|0.3696
72442999|NCT05075408|144399067|SUPERIORITY|Analysis was performed using hierarchical testing procedure. Testing was then performed sequentially in order the outcome measures were reported and continued when previous outcome measure was statistically significant at two-sided 0.025.|Strata adjusted percentage difference|14.5||||0.0686|TWO_SIDED|97.5|-3.1|32.2||Threshold of significance at 0.025.|Cochran-Mantel-Haenszel|||Nemolizumab 60 mg versus Placebo||32.2|-3.1|0.0686
72443000|NCT05075408|144399068|SUPERIORITY||Strata adjusted percentage difference|4.3||||0.5909|TWO_SIDED|97.5|-13.8|22.3|||Cochran-Mantel-Haenszel|||Analysis was performed using hierarchical testing procedure. Testing was then performed sequentially in order the outcome measures were reported and continued when previous outcome measure was statistically significant at two-sided 0.025.||22.3|-13.8|0.5909
72443001|NCT05075408|144399068|SUPERIORITY||Strata adjusted percentage difference|12.9||||0.1112|TWO_SIDED|97.5|-5.5|31.4|||Cochran-Mantel-Haenszel|||Analysis was performed using hierarchical testing procedure. Testing was then performed sequentially in order the outcome measures were reported and continued when previous outcome measure was statistically significant at two-sided 0.025.||31.4|-5.5|0.1112
72443002|NCT05075408|144399069|SUPERIORITY||Strata adjusted percentage difference|17.3||||0.0034|TWO_SIDED|97.5|4.3|30.4|||Cochran-Mantel-Haenszel|||Analysis was performed using hierarchical testing procedure. Testing was then performed sequentially in order the outcome measures were reported and continued when previous outcome measure was statistically significant at two-sided 0.025.||30.4|4.3|0.0034
72443003|NCT05075408|144399069|SUPERIORITY||Strata adjusted percentage difference|17.1||||0.0025|TWO_SIDED|97.5|4.5|29.8|||Cochran-Mantel-Haenszel|||Analysis was performed using hierarchical testing procedure. Testing was then performed sequentially in order the outcome measures were reported and continued when previous outcome measure was statistically significant at two-sided 0.025.||29.8|4.5|0.0025
72443004|NCT05075408|144399070|SUPERIORITY||Strata adjusted percentage difference|3.7||||0.5788|TWO_SIDED|97.5|-12.5|19.8|||Cochran-Mantel-Haenszel|||Analysis was performed using hierarchical testing procedure. Testing was then performed sequentially in order the outcome measures were reported and continued when previous outcome measure was statistically significant at two-sided 0.025.||19.8|-12.5|0.5788
72443005|NCT05075408|144399070|SUPERIORITY||Strata adjusted percentage difference|16.5||||0.0303|TWO_SIDED|97.5|-0.8|33.9|||Cochran-Mantel-Haenszel|||Analysis was performed using hierarchical testing procedure. Testing was then performed sequentially in order the outcome measures were reported and continued when previous outcome measure was statistically significant at two-sided 0.025.||33.9|-0.8|0.0303
72443006|NCT05075408|144399071|SUPERIORITY||Strata adjusted percentage difference|24.2||||0.0006|TWO_SIDED|97.5|8.8|39.6|||Cochran-Mantel-Haenszel|||Analysis was performed using hierarchical testing procedure. Testing was then performed sequentially in order the outcome measures were reported and continued when previous outcome measure was statistically significant at two-sided 0.025.||39.6|8.8|0.0006
72443007|NCT05075408|144399071|SUPERIORITY||Strata adjusted percentage difference|20.8||||0.0021|TWO_SIDED|97.5|6.0|35.7|||Cochran-Mantel-Haenszel|||Analysis was performed using hierarchical testing procedure. Testing was then performed sequentially in order the outcome measures were reported and continued when previous outcome measure was statistically significant at two-sided 0.025.||35.7|6.0|0.0021
72496651|NCT01162421|144522789|SUPERIORITY_OR_OTHER||Difference in percentage|-10.7||||0.358|TWO_SIDED|95.0|-33.38|11.99|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 24||11.99|-33.38|0.358
72443008|NCT05075408|144399072|SUPERIORITY||Strata adjusted percentage difference|14.0||||0.0028|TWO_SIDED|97.5|3.8|24.1|||Cochran-Mantel-Haenszel|||Analysis was performed using hierarchical testing procedure. Testing was then performed sequentially in order the outcome measures were reported and continued when previous outcome measure was statistically significant at two-sided 0.025.||24.1|3.8|0.0028
72443009|NCT05075408|144399072|SUPERIORITY||Strata adjusted percentage difference|19.0||||0.0003|TWO_SIDED|97.5|7.6|30.5|||Cochran-Mantel-Haenszel|||Analysis was performed using hierarchical testing procedure. Testing was then performed sequentially in order the outcome measures were reported and continued when previous outcome measure was statistically significant at two-sided 0.025.||30.5|7.6|0.0003
72443010|NCT03358875|144399090|SUPERIORITY||Hazard Ratio (HR)|0.64|||<|0.0001|TWO_SIDED|95.0|0.527|0.778||OS in the ITT population was tested at one-sided p value boundary of 0.0120.|1-sided Log Rank Test|Stratified by stratification factors: histology (squamous vs non-squamous), line of therapy (second vs third), and PDL1 expression (≥25% vs \<25% TC).|A stratified Cox proportional hazards model with Efron's method of tie handling was used to determine hazard ratio (HR) and its 95% confidence interval (CI).|||0.778|0.527|<0.0001
72443011|NCT03358875|144399091|SUPERIORITY||Hazard Ratio (HR)|0.53|||<|0.0001|TWO_SIDED|95.0|0.407|0.702||OS in the PD-L1 positive analysis set was tested at the one-sided p-value boundary of 0.025.|1-sided Log Rank Test|Stratified by stratification factors: histology (squamous vs non-squamous) and line of therapy (second vs third).||||0.702|0.407|<0.0001
72443012|NCT03358875|144399092|SUPERIORITY||Odds Ratio (OR)|3.86|||<|0.0001|TWO_SIDED|95.0|2.336|6.393|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) chi-square test stratified by histology, line of therapy, and PDL1 expression.||||6.393|2.336|<0.0001
72443013|NCT03358875|144399093|SUPERIORITY||Odds Ratio (OR)|8.04|||<|0.0001|TWO_SIDED|95.0|3.721|17.379|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) chi-square test stratified by histology and line of therapy.||||17.379|3.721|<0.0001
72443014|NCT03358875|144399094|SUPERIORITY||Hazard Ratio (HR)|0.31|||<|0.0001|TWO_SIDED|95.0|0.176|0.536|||Log Rank|Stratified by stratification factors: histology (squamous vs non-squamous), line of therapy (second vs third), and PDL1 expression (≥25% vs \<25% TC).|A stratified Cox proportional hazards model with Efron's method of tie handling was used to determine hazard ratio (HR) and its 95% CI.|||0.536|0.176|<0.0001
72496652|NCT01162421|144522790|SUPERIORITY_OR_OTHER||Difference in percentage|11.6||||0.316|TWO_SIDED|95.0|-10.84|33.99|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 3||33.99|-10.84|0.316
72619139|NCT01550965|144769018|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.14|||<|0.001|TWO_SIDED|95.0|0.12|0.17|||Paired t-test, 2 sided|||Statistical analysis for mean change in total EQ-5D-5L total score from week 0 to week 26.||0.17|0.12|<0.001
72443015|NCT03358875|144399095|SUPERIORITY||Hazard Ratio (HR)|0.16|||<|0.0001|TWO_SIDED|95.0|0.066|0.37|||Log Rank|Stratified by stratification factors: histology (squamous vs non-squamous) and line of therapy (second vs third).|A stratified Cox proportional hazards model with Efron's method of tie handling was used to determine hazard ratio (HR) and its 95% CI.|||0.370|0.066|<0.0001
72443016|NCT03358875|144399096|SUPERIORITY||Hazard Ratio (HR)|0.63|||<|0.0001|TWO_SIDED|95.0|0.528|0.745|||Log Rank|Stratified by stratification factors: histology (squamous vs non-squamous), line of therapy (second vs third), and PDL1 expression (≥25% vs \<25% TC).|A stratified Cox proportional hazards model with Efron's method of tie handling was used to determine hazard ratio (HR) and its 95% CI.|||0.745|0.528|<0.0001
72443017|NCT03358875|144399097|SUPERIORITY||Hazard Ratio (HR)|0.38|||<|0.0001|TWO_SIDED|95.0|0.285|0.494|||Log Rank|Stratified by stratification factors: histology (squamous vs non-squamous) and line of therapy (second vs third).|A stratified Cox proportional hazards model with Efron's method of tie handling was used to determine hazard ratio (HR) and its 95% confidence interval (CI).|||0.494|0.285|<0.0001
72443018|NCT03358875|144399098|OTHER||Least Squares (LS) Mean Difference|5.7||||0.0008|TWO_SIDED|95.0|2.38|9.07|||Mixed Models Analysis|||The linear mixed-effect model for repeated measures (MMRM) includes baseline score, stratification factors, treatment arm, visit, and treatment arm by visit interaction as fixed effects and visit as a repeated measure.||9.07|2.38|0.0008
72443019|NCT03358875|144399099|OTHER||LS Mean Difference|-8.3||||0.0007|TWO_SIDED|95.0|-13.02|-3.51|||Mixed Models Analysis|||Analysis of Change from Baseline in Coughing Scale. The linear mixed-effect model for repeated measures (MMRM) includes baseline score, stratification factors, treatment arm, visit, and treatment arm by visit interaction as fixed effects and visit as a repeated measure.||-3.51|-13.02|0.0007
72443020|NCT03358875|144399099|OTHER||LS Mean Difference|-3.2||||0.0579|TWO_SIDED|95.0|-6.52|0.11|||Mixed Models Analysis|||Analysis of Change from Baseline in Dyspnoea Scale. The linear mixed-effect model for repeated measures (MMRM) includes baseline score, stratification factors, treatment arm, visit, and treatment arm by visit interaction as fixed effects and visit as a repeated measure.||0.11|-6.52|0.0579
72443021|NCT03358875|144399099|OTHER||LS Mean Difference|-2.2||||0.2472|TWO_SIDED|95.0|-6.05|1.56|||Mixed Models Analysis|||Analysis of Change from Baseline in Chest Pain Scale. The linear mixed-effect model for repeated measures (MMRM) includes baseline score, stratification factors, treatment arm, visit, and treatment arm by visit interaction as fixed effects and visit as a repeated measure.||1.56|-6.05|0.2472
72443022|NCT03599648|144399102|SUPERIORITY|||||||0.361||||||baseline versus immediately after 16-week BPT-E intervention|t-test, 2 sided|||||||.361
72443023|NCT03599648|144399102|SUPERIORITY|||||||0.126||||||baseline versus 6 months after BPT-E intervention|t-test, 2 sided|||||||.126
72443024|NCT03599648|144399102|SUPERIORITY|||||||0||||||baseline versus 12 months after BPT-E intervention|t-test, 2 sided|||||||.000
72443025|NCT03599648|144399102|SUPERIORITY|||||||0||||||baseline versus immediately after 16 week BPT-M intervention|t-test, 2 sided|||||||.000
72443026|NCT03599648|144399102|SUPERIORITY|||||||0||||||baseline versus 6 months after BPT-M intervention|t-test, 2 sided|||||||.000
72443027|NCT03599648|144399102|SUPERIORITY|||||||0||||||baseline versus 12 months after BPT-M intervention|t-test, 2 sided|||||||.000
72496653|NCT01162421|144522790|SUPERIORITY_OR_OTHER||Difference in percentage|5.1||||0.63|TWO_SIDED|95.0|-15.43|25.54|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 6||25.54|-15.43|0.630
72496654|NCT01162421|144522790|SUPERIORITY_OR_OTHER||Difference in percentage|-0.4||||0.972|TWO_SIDED|95.0|-20.94|20.21|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 9||20.21|-20.94|0.972
72496655|NCT01162421|144522790|SUPERIORITY_OR_OTHER||Difference in percentage|-14.1||||0.186|TWO_SIDED|95.0|-34.83|6.7|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 12||6.70|-34.83|0.186
72559829|NCT01942135|144650104|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.3||||0.8812|TWO_SIDED|95.0|-3.1|3.6||The priori threshold for statistical significance is 2-sided alpha=0.05. The p-value was not adjusted for multiple comparisons.|Mixed Model Analysis (2-sided)|Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.||Statistical significance for palbociclib plus fulvestrant vs placebo plus fulvestrant for financial difficulties||3.6|-3.1|0.8812
72559830|NCT01942135|144650105|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.3||||0.1386|TWO_SIDED|95.0|-0.7|5.2||The priori threshold for statistical significance is 2-sided alpha=0.05. The p-value was not adjusted for multiple comparisons.|Mixed Model Analysis (2-sided)|Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.||Statistical significance for palbociclib plus fulvestrant vs placebo plus fulvestrant for body image||5.2|-0.7|0.1386
72559831|NCT01942135|144650105|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.8||||0.5235|TWO_SIDED|95.0|-3.1|1.6||The priori threshold for statistical significance is 2-sided alpha=0.05. The p-value was not adjusted for multiple comparisons.|Mixed Model Analysis (2-sided)|Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.||Statistical significance for palbociclib plus fulvestrant vs placebo plus fulvestrant for sexual functioning||1.6|-3.1|0.5235
72443028|NCT03599648|144399103|SUPERIORITY|||||||0.035||||||Baseline versus immediately following 16-week BPT-E intervention|t-test, 2 sided|||||||.035
72443029|NCT03599648|144399103|SUPERIORITY|||||||0.001||||||Baseline versus 6-months after BPT-E intervention|t-test, 2 sided|||||||.001
72443030|NCT03599648|144399103|SUPERIORITY|||||||0||||||Baseline versus 12 months after BPT-E intervention|t-test, 2 sided|||||||.000
72443031|NCT03599648|144399103|SUPERIORITY|||||||0||||||Baseline versus immediately after 16-week BPT-M intervention|t-test, 2 sided|||||||.000
72496656|NCT01162421|144522790|SUPERIORITY_OR_OTHER||Difference in percentage|-12.6||||0.142|TWO_SIDED|95.0|-29.46|4.26|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 18||4.26|-29.46|0.142
72496657|NCT01162421|144522790|SUPERIORITY_OR_OTHER||Difference in percentage|-4.0||||0.727|TWO_SIDED|95.0|-20.34|11.52|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 24||11.52|-20.34|0.727
72559832|NCT01942135|144650105|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.4||||0.6271|TWO_SIDED|95.0|-4.4|7.3||The priori threshold for statistical significance is 2-sided alpha=0.05. The p-value was not adjusted for multiple comparisons.|Mixed Model Analysis (2-sided)|Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.||Statistical significance for palbociclib plus fulvestrant vs placebo plus fulvestrant for sexual enjoyment||7.3|-4.4|0.6271
72443032|NCT03599648|144399103|SUPERIORITY|||||||0||||||Baseline versus 6 months after BPT-M intervention|t-test, 2 sided|||||||.000
72443033|NCT03599648|144399103|SUPERIORITY|||||||0||||||Baseline versus 12 months after BPT-M intervention|t-test, 2 sided|||||||.000
72496658|NCT01162421|144522791|SUPERIORITY_OR_OTHER||Difference in percentage|6.8||||0.486|TWO_SIDED|95.0|-9.21|22.22|||Fisher Exact|Two-sided Fisher Exact test.||||22.22|-9.21|0.486
72496659|NCT01162421|144522792|SUPERIORITY_OR_OTHER||LS Mean Difference|0.03|STANDARD_ERROR_OF_MEAN|0.13||0.809|TWO_SIDED|95.0|-0.23|0.29||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 3||0.29|-0.23|0.809
72619140|NCT01550965|144769019|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.62|||<|0.001|TWO_SIDED|95.0|-12.07|-5.18|||Paired t-test, 2 sided|||Statistical analysis for mean change in WPAI-SHP: percentage of work time missed from week 0 to week 2.||-5.18|-12.07|<0.001
72443034|NCT03599648|144399104|SUPERIORITY|||||||0||||||Baseline versus immediately after 16-week BPT-E intervention|t-test, 2 sided|||||||.000
72443035|NCT03599648|144399104|SUPERIORITY|||||||0||||||Baseline versus 6 months after BPT-E intervention|t-test, 2 sided|||||||.000
72443036|NCT03599648|144399104|SUPERIORITY|||||||0||||||Baseline versus 12 months after BPT-E intervention|t-test, 2 sided|||||||.000
72443037|NCT03599648|144399104|SUPERIORITY|||||||0||||||Baseline versus immediately after 16-week BPT-M intervention|t-test, 2 sided|||||||.000
72443038|NCT03599648|144399104|SUPERIORITY|||||||0||||||Baseline versus 6 months after BPT-M intervention|t-test, 2 sided|||||||.000
72443039|NCT03599648|144399104|SUPERIORITY|||||||0||||||baseline versus 12 months after BPT-M intervention|t-test, 2 sided|||||||.000
72443040|NCT02380612|144399106|OTHER||Geometric Mean Ratio|1.4575|||||TWO_SIDED|||||||||||||
72443041|NCT03494504|144399197|SUPERIORITY||Odds Ratio (OR)|2.36|||||TWO_SIDED|95.0|1.46|3.84||||||||3.84|1.46|
72443042|NCT03494504|144399197|SUPERIORITY||Odds Ratio (OR)|1.81|||||TWO_SIDED|95.0|1.11|2.94||||||||2.94|1.11|
72443043|NCT03517553|144399211|SUPERIORITY|||||||0.999||||||Threshold for statistical significance is P\<0.05|Kruskal-Wallis|||||||0.999
72443044|NCT03517553|144399211|SUPERIORITY|||||||0.768|||||||Kruskal-Wallis|||||||0.768
72443045|NCT03517553|144399212|SUPERIORITY|||||||0.869|||||||Kruskal-Wallis|||||||0.869
72443046|NCT03517553|144399212|SUPERIORITY|||||||0.813|||||||Kruskal-Wallis|||||||0.813
72443047|NCT03517553|144399212|SUPERIORITY|||||||0.978|||||||Kruskal-Wallis|||||||0.978
72443048|NCT03517553|144399212|SUPERIORITY|||||||0.731|||||||Kruskal-Wallis|||||||0.731
72443049|NCT03517553|144399212|SUPERIORITY|||||||0.703|||||||Kruskal-Wallis|||||||0.703
72443050|NCT03517553|144399212|SUPERIORITY|||||||0.909|||||||Kruskal-Wallis|||||||0.909
72443051|NCT02879448|144399221|NON_INFERIORITY|The non-inferiority margin was developed based on reported rates for other devices. Therefore, the expected rate of the safety endpoint was assumed to be 15%. A non-inferiority margin of 5.8% represents a relative risk of 1.39.||||||0.0002|||||||Kaplan-Meier estimate|||"The following hypothesis was tested:~H0: p1(Amulet) - p1 (Watchman) ≥ Δ1~H1: p1(Amulet) - p1(Watchman) \< Δ1;~where Δ1 is the absolute value of the non-inferiority margin for the safety endpoint and p1 is the probability of a primary safety endpoint event."||||0.0002
72443052|NCT02879448|144399222|NON_INFERIORITY|The non-inferiority margin for this endpoint was developed based on the reported rates of ischemic stroke or systemic embolism for the Watchman. The 18-month rate of ischemic stroke or systemic embolism for the Watchman device has been reported in the literature as 4.2%. A non-inferiority margin of 3.2%, which represents a relative risk of 1.76, ensured that the rate observed was at most twice the rate expected with oral anticoagulant therapy.|||||<|0.0001|||||||Kaplan-Meier estimate|||"The following hypothesis was tested:~H0: p2(Amulet) - p2(Watchman) ≥ Δ2~H1: p2(Amulet) - p2(Watchman) \< Δ2;~where Δ2 is the absolute value of the non-inferiority margin for the effectiveness endpoint and p2 is the probability of a subject experiencing a primary effectiveness endpoint event."||||<0.0001
72443053|NCT02879448|144399223|NON_INFERIORITY|The non-inferiority margin for this endpoint was developed based on the reported closure rate for the Watchman device. The rate of device closure for the Watchman device has been reported in the literature as 95% (i.e., 5% had a residual jet \> 5mm). A non-inferiority margin of -3%, which represents a relative risk of 1.60, allows for trial to trial variability and implanter learning associated with implantation of a new device (Amulet).|||||<|0.0001|||||||Farrington Manning test|||"The following hypothesis was tested:~H0: p3(Amulet) - p3(Watchman) ≤ -Δ3~H1: p3(Amulet) - p3(Watchman) \> -Δ3;~where Δ3 is the absolute value of the non-inferiority margin and p3 is the 45-day closure probability."||||<0.0001
72443054|NCT02879448|144399224|NON_INFERIORITY|"The following hypothesis was tested:~H1: p4(Amulet) - p4(Watchman) \< 4.5%"|||||<|0.0001|||||||Kaplan-Meier estimate|||||||<0.0001
72443055|NCT02879448|144399225|SUPERIORITY|"The following hypothesis was tested:~H1: p5(Amulet) - p5(Watchman) \< 0"||||||0.3229|||||||Kaplan-Meier estimate|||||||0.3229
72443056|NCT02879448|144399226|SUPERIORITY|"The following hypothesis was tested:~H1: p1(Amulet) - p1(Watchman) \< 0"||||||0.466|||||||Kaplan-Meier estimate|||||||0.4660
72443057|NCT02879448|144399227|SUPERIORITY|"The following hypothesis was tested:~H1: p2(Amulet) - p2(Watchman) \< 0"||||||0.5017|||||||Kaplan-Meier estimate|||||||0.5017
72443058|NCT02879448|144399228|SUPERIORITY|"The following hypothesis was tested:~H1: p3(Amulet) - p3(Watchman) \> 0"||||||0.0025|||||||Farrington Manning test|||||||0.0025
72443059|NCT05952076|144399232|OTHER||Adjusted mean difference|0.11||||0.6863|TWO_SIDED|95.0|-0.44|0.67|||Mixed Models Analysis|See Estimation Comments|The mixed model included treatment and visit as factors, including the interaction term, and was adjusted by baseline WAZ and baseline age (days). A random intercept for participant was included.|||0.67|-0.44|0.6863
72443060|NCT05952076|144399233|OTHER||Adjusted mean difference|109.3||||0.5567|TWO_SIDED|95.0|-259.76|478.36|||Mixed Models Analysis|See Estimation Comments|The mixed model included treatment and visit as factors, including the interaction term, and was adjusted by baseline weight (grams) and baseline age (days). A random intercept for participant was included.|||478.36|-259.76|0.5567
72496660|NCT01162421|144522792|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.132||0.194|TWO_SIDED|95.0|-0.44|0.09||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 6||0.09|-0.44|0.194
72496661|NCT01162421|144522792|SUPERIORITY_OR_OTHER||LS Mean Difference|0.02|STANDARD_ERROR_OF_MEAN|0.132||0.863|TWO_SIDED|95.0|-0.24|0.29||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 9||0.29|-0.24|0.863
72443061|NCT05952076|144399234|OTHER||Adjusted mean difference|0.1||||0.7275|TWO_SIDED|95.0|-0.46|0.66|||Mixed Models Analysis|See Estimation Comments|The mixed model included treatment and visit as factors, including the interaction term, and was adjusted by baseline WAZ, baseline age (days) and study intervention compliance. A random intercept for participant was included.|||0.66|-0.46|0.7275
72443062|NCT01046136|144399240|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0096|||||||Regression, Logistic|p-value is from a logistic regression model with terms for treatment group and center||Investigator's End-of-Study Assessment NOTE: All assessments of efficacy were considered exploratory and were given equal consideration, and were carried out on both the MITT and PP populations. LOCF method was applied to missing post baseline measurements in analyses of the MITT population.||||0.0096
72443063|NCT01046136|144399242|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0293|||||||Wilcoxon (Mann-Whitney)|P-value is from a Wilcoxon rank sum test comparing the two treatment groups.||||||0.0293
72443064|NCT04110054|144399256|EQUIVALENCE|Placebo (N = 102) vs S-600918 50 mg, 150 mg, 300 mg||||||0.9334||||||P-value was evaluated at the 2-sided alpha level of 0.05.|ANCOVA|||The null hypotheses of equality between the treatment and placebo effects were tested using a mixed model, containing treatment group, week, and interaction between treatment groups and week as fixed effects; participant as random effect; and region and the common logarithm of the frequency of coughs per hour at baseline as covariates. Covariance structure was given as unstructured.||||0.9334
72443065|NCT00093015|144399267|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|1.05||||0.41||95.0|0.94|1.17||Nominal p-value from a 2-sided log rank test is presented. The primary cardiovascular composite endpoint was tested at the 0.04056 significance level at final analysis after accounting for 4 planned interim analyses (overall alpha = 0.048).|Log Rank|A 2-sided log-rank test comparing the survival functions of the 2 groups stratified by baseline proteinuria and CV disease (CVD) history.|Treatment effect was estimated using a hazards ratio and 95% confidence interval (CI) obtained from a Cox proportional hazards model stratified by baseline proteinuria and CVD history. Hazard ratio (darbepoetin alfa / placebo)|||1.17|0.94|0.41
72443066|NCT00093015|144399268|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|1.06||||0.29||95.0|0.95|1.19||Nominal p-value from a 2-sided log rank test is presented. The primary renal composite endpoint was tested at the 0.002 significance level at final analysis.|Log Rank|A 2-sided log-rank test comparing the survival functions of the 2 groups stratified by baseline proteinuria and CV disease (CVD) history.|Treatment effect was estimated using a hazards ratio and 95% confidence interval (CI) obtained from a Cox proportional hazards model stratified by baseline proteinuria and CVD history. Hazard ratio (darbepoetin alfa / placebo)|||1.19|0.95|0.29
72443067|NCT00093015|144399269|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|1.05||||0.48||95.0|0.92|1.21||Nominal p-value from a 2-sided log rank test is presented.|Log Rank|A 2-sided log-rank test comparing the survival functions of the 2 groups stratified by baseline proteinuria and CV disease (CVD) history.|Treatment effect was estimated using a hazards ratio and 95% confidence interval (CI) obtained from a Cox proportional hazards model stratified by baseline proteinuria and CVD history. Hazard ratio (darbepoetin alfa / placebo)|||1.21|0.92|0.48
72559833|NCT01942135|144650105|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.6||||0.0845|TWO_SIDED|95.0|-0.5|7.6||The priori threshold for statistical significance is 2-sided alpha=0.05. The p-value was not adjusted for multiple comparisons.|Mixed Model Analysis (2-sided)|Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.||Statistical significance for palbociclib plus fulvestrant vs placebo plus fulvestrant for future perspective||7.6|-0.5|0.0845
72388452|NCT00289783|144284822|EQUIVALENCE|For each pair of lots and for the immune response to hSBA-MenY, the two-sided 95% confidence interval (CI) on the geometric mean titers (GMTs) ratio between lots is within the \[0.5; 2.0\] interval.|GMT ratio|1.4|||||TWO_SIDED|95.0|0.99|1.97||||||To demonstrate the lot-to-lot consistency of 3 manufacturing lots of Hib-MenCY-TT vaccine co-administered with DTPa-HBV-IPV vaccine following 3 primary doses in terms of immunogenicity for N. meningitidis serogroup Y (MenY) as measured by a serum bactericidal assay using human complement (hSBA).||1.97|0.99|
72388453|NCT00289783|144284822|EQUIVALENCE|For each pair of lots and for the immune response to hSBA-MenY, the two-sided 95% confidence interval (CI) on the geometric mean titers (GMTs) ratio between lots is within the \[0.5; 2.0\] interval.|GMT ratio|0.87|||||TWO_SIDED|95.0|0.62|1.21||||||To demonstrate the lot-to-lot consistency of 3 manufacturing lots of Hib-MenCY-TT vaccine co-administered with DTPa-HBV-IPV vaccine following 3 primary doses in terms of immunogenicity for N. meningitidis serogroup Y (MenY) as measured by a serum bactericidal assay using human complement (hSBA).||1.21|0.62|
72388454|NCT00289783|144284823|NON_INFERIORITY|Criteria for immunogenicity of MenC (42 days after the fourth dose): Lower limit of the asymptotic 95% CI for the geometric mean of individual ratio of post-dose 4/pre-dose 4 is ≥ 2.|GMT ratio|12.0|||||TWO_SIDED|95.0|10.4|13.8||||||To evaluate the specific effect of a fourth dose of Menhibrix vaccine co-administered with M-M-R II and Varivax vaccines at 12 to 15 months of age in terms of a fourth dose vaccine response as measured by hSBA-MenC.||13.8|10.4|
72388455|NCT00289783|144284823|NON_INFERIORITY|Point estimate = Lower limit (LL) = Upper limit (UL) as LL and UL values were not available due to the departure from lognormal distribution (large number of imputed values)|GMT ratio|1.4|||||TWO_SIDED|95.0|1.4|1.4||||||To evaluate the specific effect of a fourth dose of Menhibrix vaccine co-administered with M-M-R II and Varivax vaccines at 12 to 15 months of age in terms of a fourth dose vaccine response as measured by hSBA-MenC.||1.4|1.4|
72388456|NCT00289783|144284824|NON_INFERIORITY|Criteria for immunogenicity of MenY (42 days after the fourth dose): Lower limit of the asymptotic 95% CI for the geometric mean of individual ratio of post-dose 4/pre-dose 4 is ≥ 2.|GMT ratio|11.8|||||TWO_SIDED|95.0|10.2|13.8||||||To evaluate the specific effect of a fourth dose of Menhibrix vaccine co-administered with M-M-R II and Varivax vaccines at 12 to 15 months of age in terms of a fourth dose vaccine response as measured by hSBA-MenY.||13.8|10.2|
72388457|NCT00289783|144284824|NON_INFERIORITY|Point estimate = Lower limit (LL) = Upper limit (UL) as LL and UL values were not available due to the departure from lognormal distribution (large number of imputed values).|GMT ratio|21.1|||||TWO_SIDED|95.0|21.1|21.1||||||To evaluate the specific effect of a fourth dose of Menhibrix vaccine co-administered with M-M-R II and Varivax vaccines at 12 to 15 months of age in terms of a fourth dose vaccine response as measured by hSBA-MenY.||21.1|21.1|
72388458|NCT00289783|144284828|NON_INFERIORITY|Lower limit of the standardized asymptotic 95% CI for the difference (Menhibrix vaccine fourth dose group minus ActHIB fourth dose group) in the percentage of subjects with seroconversion ≥ 150 mIU/mL, in initially seronegative subjects (\<150 mIU/mL), for anti-measles antibody is ≥-5% (clinical limit for non-inferiority).|Difference in percentage|-0.15|||||TWO_SIDED|95.0|-2.56|3.06||||||To demonstrate the non-inferiority of M-M-R II vaccine when co-administered with a fourth dose of Menhibrix vaccine compared to M-M-R II vaccine co-administered with a fourth dose of PedvaxHIB vaccine, each co-administered with Varivax vaccine.||3.06|-2.56|
72388459|NCT00289783|144284829|NON_INFERIORITY|Criteria for non-inferiority (42 days after the fourth dose): Lower limit of the two-sided standardized asymptotic 95% CI on the difference (Menhibrix vaccine fourth dose group minus ActHIB fourth dose group) in the percentage of subjects with anti-PRP concentration ≥ 1.0 µg/mL is ≥ -10% (clinical limit for non-inferiority)|Difference in percentage|-0.04|||||TWO_SIDED|95.0|-1.78|3.57||||||To demonstrate that, following a fourth dose, the immune response to Hib polysaccharide (PRP) in the group that received 3 primary vaccine doses of Menhibrix vaccine and a fourth dose of Menhibrix vaccine coadministered with M-M-R II and Varivax vaccines was non-inferior to the corresponding immune response in the group that received 3 primary vaccine doses of ActHIB vaccine and a fourth dose of PedvaxHIB vaccine co-administered with M-M-R II and Varivax vaccines.||3.57|-1.78|
72388460|NCT00289783|144284830|NON_INFERIORITY|Criterion for non-inferiority (42 days after fourth dose vaccination): Lower limit of the standardized asymptotic 95% CI for the difference (Menhibrix vaccine fourth dose group minus ActHIB fourth dose group) in the percentage of subjects with a seroconversion ≥28 ED50, in subjects with initial anti-mumps antibody \< 28 ED50, for anti-mumps antibody is ≥ -5% (clinical limit for non-inferiority).|Difference in percentage|-1.0|||||TWO_SIDED|95.0|-2.16|0.98||||||To demonstrate the non-inferiority of M-M-R II vaccine when co-administered with a fourth dose of Menhibrix vaccine compared to M--M-R II vaccine co-administered with a fourth dose of PedvaxHIB vaccine, each co-administered with Varivax vaccine.||0.98|-2.16|
72388461|NCT00289783|144284831|NON_INFERIORITY|Criterion for non-inferiority (42 days after fourth dose vaccination): Lower limit of the standardized asymptotic 95% CI for the difference (Menhibrix vaccine fourth dose group minus ActHIB fourth dose group) in the percentage of subjects with seroresponse ≥10 IU/ml, in initially seronegative subjects (\< 4 IU/ml), for anti-rubella antibody is ≥ -5% (clinical limit for non-inferiority).|Difference in percentage|0.12|||||TWO_SIDED|95.0|-0.57|1.73||||||To demonstrate the non-inferiority of M-M-R II vaccine when co-administered with a fourth dose of Menhibrix vaccine compared to M-M-R II vaccine co-administered with a fourth dose of PedvaxHIB vaccine, each co-administered with Varivax vaccine.||1.73|-0.57|
72443068|NCT00093015|144399270|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|1.05||||0.61||95.0|0.88|1.25||Nominal p-value from a 2-sided log rank test is presented.|Log Rank|A 2-sided log-rank test comparing the survival functions of the 2 groups stratified by baseline proteinuria and CV disease (CVD) history.|Treatment effect was estimated using a hazards ratio and 95% confidence interval (CI) obtained from a Cox proportional hazards model stratified by baseline proteinuria and CVD history. Hazard ratio (darbepoetin alfa / placebo)|||1.25|0.88|0.61
72443069|NCT00093015|144399271|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|0.96||||0.73||95.0|0.75|1.23||Nominal p-value from a 2-sided log rank test is presented.|Log Rank|A 2-sided log-rank test comparing the survival functions of the 2 groups stratified by baseline proteinuria and CV disease (CVD) history.|Treatment effect was estimated using a hazards ratio and 95% confidence interval (CI) obtained from a Cox proportional hazards model stratified by baseline proteinuria and CVD history. Hazard ratio (darbepoetin alfa / placebo)|||1.23|0.75|0.73
72443070|NCT00093015|144399272|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|1.92|||<|0.001||95.0|1.38|2.68||Nominal p-value from a 2-sided log rank test is presented.|Log Rank|A 2-sided log-rank test comparing the survival functions of the 2 groups stratified by baseline proteinuria and CV disease (CVD) history.|Treatment effect was estimated using a hazards ratio and 95% confidence interval (CI) obtained from a Cox proportional hazards model stratified by baseline proteinuria and CVD history. Hazard ratio (darbepoetin alfa / placebo)|||2.68|1.38|<0.001
72443071|NCT00093015|144399273|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|0.89||||0.24||95.0|0.74|1.08||Nominal p-value from a 2-sided log rank test is presented.|Log Rank|A 2-sided log-rank test comparing the survival functions of the 2 groups stratified by baseline proteinuria and CV disease (CVD) history.|Treatment effect was estimated using a hazards ratio and 95% confidence interval (CI) obtained from a Cox proportional hazards model stratified by baseline proteinuria and CVD history. Hazard ratio (darbepoetin alfa / placebo)|||1.08|0.74|0.24
72443072|NCT00093015|144399274|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|1.02||||0.83||95.0|0.87|1.18||Nominal p-value from a 2-sided log rank test is presented.|Log Rank|A 2-sided log-rank test comparing the survival functions of the 2 groups stratified by baseline proteinuria and CV disease (CVD) history.|Treatment effect was estimated using a hazards ratio and 95% confidence interval (CI) obtained from a Cox proportional hazards model stratified by baseline proteinuria and CVD history. Hazard ratio (darbepoetin alfa / placebo)|||1.18|0.87|0.83
72496662|NCT01162421|144522792|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.129||0.452|TWO_SIDED|95.0|-0.16|0.35||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 12||0.35|-0.16|0.452
72443073|NCT00093015|144399275|SUPERIORITY_OR_OTHER_LEGACY||Slope|-0.12||||0.54||95.0|-0.51|0.26||Nominal p-value is from the term treatment group\*visit in the mixed model.|Mixed Models Analysis|Adjusted for baseline eGFR and the stratification factors of proteinuria and CVD history.|Estimated difference in rate of decline in eGFR per year between darbepoetin alfa and placebo.|||0.26|-0.51|0.54
72443074|NCT00093015|144399276|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.33|STANDARD_DEVIATION|0.35|<|0.001||95.0|0.64|2.02||Nominal p-value is presented.|t-test, 2 sided||Difference (darbepoetin alfa - placebo)|||2.02|0.64|<0.001
72443075|NCT00093015|144399277|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|0.84||||0.4||95.0|0.55|1.27||Nominal p-value from a 2-sided log rank test is presented.|Log Rank|A 2-sided log-rank test comparing the survival functions of the 2 groups stratified by baseline proteinuria and CV disease (CVD) history.|Treatment effect was estimated using a hazards ratio and 95% confidence interval (CI) obtained from a Cox proportional hazards model stratified by baseline proteinuria and CVD history. Hazard ratio (darbepoetin alfa / placebo)|||1.27|0.55|0.40
72496663|NCT01162421|144522792|SUPERIORITY_OR_OTHER||LS Mean Difference|0.05|STANDARD_ERROR_OF_MEAN|0.141||0.738|TWO_SIDED|95.0|-0.23|0.33||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 18||0.33|-0.23|0.738
72496664|NCT01162421|144522792|SUPERIORITY_OR_OTHER||LS Mean Difference|0.08|STANDARD_ERROR_OF_MEAN|0.148||0.572|TWO_SIDED|95.0|-0.21|0.38||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 24||0.38|-0.21|0.572
72496665|NCT01162421|144522793|SUPERIORITY_OR_OTHER||Difference in percentage|-11.9||||0.299|TWO_SIDED|95.0|-34.05|10.31|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 3||10.31|-34.05|0.299
72496666|NCT01162421|144522793|SUPERIORITY_OR_OTHER||Difference in percentage|-3.0||||0.796|TWO_SIDED|95.0|-25.77|19.77|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 6||19.77|-25.77|0.796
72496667|NCT01162421|144522793|SUPERIORITY_OR_OTHER||Difference in percentage|7.0||||0.54|TWO_SIDED|95.0|-15.3|29.22|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 9||29.22|-15.30|0.540
72496668|NCT01162421|144522793|SUPERIORITY_OR_OTHER||Difference in percentage|-9.6||||0.392|TWO_SIDED|95.0|-31.39|12.19|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 12||12.19|-31.39|0.392
72496669|NCT01162421|144522793|SUPERIORITY_OR_OTHER||Difference in percentage|-3.3||||0.776|TWO_SIDED|95.0|-25.96|19.37|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 18||19.37|-25.96|0.776
72443076|NCT00632203|144399280|SUPERIORITY_OR_OTHER|||||||0.6995|||||||2-sided Exact Pearson Chi-square Test|||||||0.6995
72443077|NCT02641912|144399287|SUPERIORITY_OR_OTHER||Least sqaure (LS) mean difference|0.63||||0.0084|TWO_SIDED|95.0|0.17|1.1|||ANOVA|From ANOVA model with factors for treatment and confirmed Sjögren's syndrome status stratification using Observed Margins option.|Difference is first named treatment minus second named treatment such that a positive difference favours the first named treatment.|||1.10|0.17|0.0084
72443078|NCT02638337|144399390|SUPERIORITY||LS Mean Difference|-21.8|||<|0.0001|TWO_SIDED|95.0|-25.7|-18.0|||Mixed-effects model repeated measures|MMRM model with treatment, week, treatment by week interaction, and study center as fixed effects; and baseline value modeled as a covariate.||For the percentage of parabasal cells a mixed-effects model for repeated measures (MMRM) approach was used, with repeated measurements of the change from baseline as the response variable; treatment, week, treatment by week interaction, and study center as fixed effects; and baseline value modeled as a covariate.||-18.0|-25.7|<0.0001
72443079|NCT02638337|144399391|SUPERIORITY||LS Mean Difference|7.2|||<|0.0001|TWO_SIDED|95.0|5.2|9.1|||Mixed-effects model repeated measures|MMRM model with treatment, week, treatment by week interaction, and study center as fixed effects; and baseline value modeled as a covariate.||||9.1|5.2|<0.0001
72443080|NCT02638337|144399392|SUPERIORITY||LS Mean Difference|-0.72|||<|0.0001|TWO_SIDED|95.0|-0.84|-0.59|||Mixed-effects model repeated measures|MMRM model with treatment, week, treatment by week interaction, and study center as fixed effects; and baseline value modeled as a covariate.||||-0.59|-0.84|<0.0001
72559834|NCT01942135|144650106|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.4||||0.7273|TWO_SIDED|95.0|-1.6|2.3||The priori threshold for statistical significance is 2-sided alpha=0.05. The p-value was not adjusted for multiple comparisons.|Mixed Model Analysis (2-sided)|Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.||Statistical significance for palbociclib plus fulvestrant vs placebo plus fulvestrant for systemic therapy side effects||2.3|-1.6|0.7273
72559835|NCT01942135|144650106|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.9||||0.2671|TWO_SIDED|95.0|-2.6|0.7||The priori threshold for statistical significance is 2-sided alpha=0.05. The p-value was not adjusted for multiple comparisons.|Mixed Model Analysis (2-sided)|Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.||Statistical significance for palbociclib plus fulvestrant vs placebo plus fulvestrant for breast symptoms||0.7|-2.6|0.2671
72619141|NCT01550965|144769019|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.22|||<|0.001|TWO_SIDED|95.0|-16.27|-8.16|||Paired t-test, 2 sided|||Statistical analysis for mean change in WPAI-SHP: percentage of work time missed from week 0 to week 8.||-8.16|-16.27|<0.001
72619142|NCT01550965|144769019|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.61|||<|0.001|TWO_SIDED|95.0|-15.82|-7.4|||Paired t-test, 2 sided|||Statistical analysis for mean change in WPAI-SHP: percentage of work time missed from week 0 to week 18. Efficacy assessments were not specified at week 18; missing data at week 18 were imputed using last observation carried forward (LOCF).||-7.40|-15.82|<0.001
72496670|NCT01162421|144522793|SUPERIORITY_OR_OTHER||Difference in percentage|-16.1||||0.166|TWO_SIDED|95.0|-38.64|6.4|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 24||6.40|-38.64|0.166
72496671|NCT01162421|144522794|SUPERIORITY_OR_OTHER||Difference in percentage|-10.9||||0.283|TWO_SIDED|95.0|-30.84|9.01|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 3||9.01|-30.84|0.283
72496672|NCT01162421|144522794|SUPERIORITY_OR_OTHER||Difference in percentage|7.9||||0.444|TWO_SIDED|95.0|-12.17|28.0|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 6||28.00|-12.17|0.444
72496673|NCT01162421|144522794|SUPERIORITY_OR_OTHER||Difference in percentage|1.6||||0.885|TWO_SIDED|95.0|-20.16|23.38|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 9||23.38|-20.16|0.885
72496674|NCT01162421|144522794|SUPERIORITY_OR_OTHER||Difference in percentage|-1.0||||0.931|TWO_SIDED|95.0|-22.54|20.64|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 12||20.64|-22.54|0.931
72496675|NCT01162421|144522794|SUPERIORITY_OR_OTHER||Difference in percentage|2.2||||0.836|TWO_SIDED|95.0|-18.63|23.03|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 18||23.03|-18.63|0.836
72496676|NCT01162421|144522794|SUPERIORITY_OR_OTHER||Difference in percentage|2.2||||0.836|TWO_SIDED|95.0|-18.63|23.03|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 24||23.03|-18.63|0.836
72496677|NCT01162421|144522795|SUPERIORITY_OR_OTHER||LS Mean Difference|0.9|STANDARD_ERROR_OF_MEAN|2.25||0.699|TWO_SIDED|95.0|-3.6|5.4||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 3||5.4|-3.6|0.699
72496678|NCT01162421|144522795|SUPERIORITY_OR_OTHER||LS Mean Difference|2.8|STANDARD_ERROR_OF_MEAN|2.45||0.261|TWO_SIDED|95.0|-2.1|7.7||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 6||7.7|-2.1|0.261
72496679|NCT01162421|144522795|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.5|STANDARD_ERROR_OF_MEAN|2.36||0.514|TWO_SIDED|95.0|-6.2|3.2||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 9||3.2|-6.2|0.514
72496680|NCT01162421|144522795|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.7|STANDARD_ERROR_OF_MEAN|2.5||0.283|TWO_SIDED|95.0|-7.7|2.3||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 12||2.3|-7.7|0.283
72496681|NCT01162421|144522795|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.0|STANDARD_ERROR_OF_MEAN|2.75||0.461|TWO_SIDED|95.0|-7.5|3.4||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 18||3.4|-7.5|0.461
72496682|NCT01162421|144522795|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|2.78||0.703|TWO_SIDED|95.0|-6.6|4.5||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 24||4.5|-6.6|0.703
72496683|NCT01162421|144522796|SUPERIORITY_OR_OTHER||Difference in percentage|-1.1||||1|TWO_SIDED|95.0|-17.94|15.16|||Fisher Exact|Two-sided Fisher Exact test.||Month 3||15.16|-17.94|1.000
72496684|NCT01162421|144522796|SUPERIORITY_OR_OTHER||Difference in percentage|-6.4||||0.468|TWO_SIDED|95.0|-22.34|8.81|||Fisher Exact|Two-sided Fisher Exact test.||Month 6||8.81|-22.34|0.468
72496685|NCT01162421|144522796|SUPERIORITY_OR_OTHER||Difference in percentage|-11.9||||0.142|TWO_SIDED|95.0|-27.88|3.16|||Fisher Exact|Two-sided Fisher Exact test.||Month 9||3.16|-27.88|0.142
72496686|NCT01162421|144522796|SUPERIORITY_OR_OTHER||Difference in percentage|4.6||||0.712|TWO_SIDED|95.0|-11.08|19.83|||Fisher Exact|Two-sided Fisher Exact test.||Month 12||19.83|-11.08|0.712
72496687|NCT01162421|144522796|SUPERIORITY_OR_OTHER||Difference in percentage|7.2||||0.482|TWO_SIDED|95.0|-8.92|22.89|||Fisher Exact|Two-sided Fisher Exact test.||Month 18||22.89|-8.92|0.482
72496688|NCT01162421|144522796|SUPERIORITY_OR_OTHER||Difference in percentage|-6.2||||0.418|TWO_SIDED|95.0|-21.18|7.69|||Fisher Exact|Two-sided Fisher Exact test.||Month 24||7.69|-21.18|0.418
72496689|NCT01162421|144522797|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.4|STANDARD_ERROR_OF_MEAN|5.86||0.453|TWO_SIDED|95.0|-16.3|7.4||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 3||7.4|-16.3|0.453
72496690|NCT01162421|144522797|SUPERIORITY_OR_OTHER||LS Mean Difference|-7.9|STANDARD_ERROR_OF_MEAN|5.88||0.187|TWO_SIDED|95.0|-19.7|4.0||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 6||4.0|-19.7|0.187
72619143|NCT01550965|144769019|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.43|||<|0.001|TWO_SIDED|95.0|-15.5|-7.35|||Paired t-test, 2 sided|||Statistical analysis for mean change in WPAI-SHP: percentage of work time missed from week 0 to week 26.||-7.35|-15.50|<0.001
72388462|NCT00289783|144284832|NON_INFERIORITY|Criterion for non-inferiority (42 days after the fourth dose vaccination): Lower limit of the standardized asymptotic 95% CI for the difference (Menhibrix vaccine fourth dose group minus ActHIB fourth dose group) in the percentage of subjects with seroconversion ≥ 1:5 dilution, in initially seronegative subjects (\< 1:5), for anti-varicella antibody is ≥ -10% (clinical limit for non-inferiority).|Difference in percentage|-0.14|||||TWO_SIDED|95.0|-0.78|1.56||||||To demonstrate the non-inferiority of Varivax vaccine co-administered with a fourth dose of Menhibrix vaccine compared to Varivax vaccine co-administered with a fourth dose of PedvaxHIB vaccine, each co-administered with M-M-R II vaccine in terms of immunogenicity to varicella as measured by fluorescent antibody to membrane antigen (FAMA).||1.56|-0.78|
72388463|NCT03128411|144284916|SUPERIORITY||||||<|0.0001|||||||z-test, 1-sided|||With a sample size of 60 participants, study was powered at \>82% to test null hypothesis: true MMR rate at 12 months (48 weeks) is 25% versus alternative hypothesis: true MMR rate is 40% with one-sided alpha of 5%.||||<0.0001
72388464|NCT04547712|144284953|SUPERIORITY||Proportion expressed as a percentage|78.9|||||ONE_SIDED|97.5|59.4||||||The confidence interval lower limit was above the performance goal of 50%, the primary objective was met.|"Null Hypothesis: The proportion of subjects with On time without troublesome dyskinesia during aDBS single threshold mode Evaluation Period exceeding threshold \<= 50%; Alternative Hypothesis: The proportion of subjects with On time without troublesome dyskinesia during aDBS single threshold mode Evaluation Period exceeding threshold \> 50%"|||59.4|
72388465|NCT04547712|144284953|SUPERIORITY||Proportion expressed as a percentage|91.0|||||ONE_SIDED|97.5|75.6||||||The confidence interval lower limit was above the performance goal of 50%, the primary objective was met.|"Null Hypothesis: The proportion of subjects with On time without troublesome dyskinesia during aDBS dual threshold mode Evaluation Period exceeding threshold \<= 50%; Alternative Hypothesis: The proportion of subjects with On time without troublesome dyskinesia during aDBS dual threshold mode Evaluation Period exceeding threshold \> 50%"|||75.6|
72388466|NCT04547712|144284954|SUPERIORITY|||||||0.012||||||Nominal p-value is provided.|t-test, 2 sided|||Null Hypothesis: Mean Difference between aDBS single threshold (Evaluation Phase) minus cDBS (Baseline Phase) for TEED \>= 0; Alternative Hypothesis: Mean Difference between aDBS single threshold (Evaluation Phase) minus cDBS (Baseline Phase) for TEED \< 0||||0.0120
72388467|NCT04547712|144284954|SUPERIORITY|||||||0.0491||||||Nominal p-value is provided.|t-test, 2 sided|||Null Hypothesis: Mean Difference between aDBS dual threshold (Evaluation Phase) minus cDBS (Baseline Phase) for TEED \>= 0; Alternative Hypothesis: Mean Difference between aDBS dual threshold (Evaluation Phase) minus cDBS (Baseline Phase) for TEED \< 0||||0.0491
72388468|NCT00594659|144284956|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0|||||accelerated bootstrapping|||Pairwise comparison; non-parametric tests performed because of non-normal distribution||||<0.05
72388469|NCT00594659|144284956|SUPERIORITY_OR_OTHER||||||<|0.05|||||||accelerated bootstrapping|||pairwise comparison; non-parametric analysis||||< .05
72388470|NCT00594659|144284956|SUPERIORITY_OR_OTHER||||||>|0.05|||||||accelerated bootstrapping|||nonparametric pairwise comparison; non-normal distribution||||> 0.05
72388471|NCT00594659|144284957|SUPERIORITY_OR_OTHER||Slope|3.11|STANDARD_ERROR_OF_MEAN|0.69|<|0.05|TWO_SIDED||||||piecewise mixed model with logit link an|Performed across all assessments.|Slope and p-value above are for group 1: baseline to ETX. Group 3 vs. Group 1 baseline to ETX slope, p \< 0.05. All other pairwise comparisons p \> 0.05.|pairwise comparisons among groups across 4 follow-up timepoints||||< 0.05
72388472|NCT04997304|144285132|OTHER|Test of paired differences||||||0.0019|||||||t-test, 2 sided|Paired t-test||This analysis applies only to comparison of baseline and exacerbation for AirDuo||||0.0019
72388473|NCT04997304|144285132|OTHER|Test of paired differences||||||0.002|||||||t-test, 2 sided|Paired t-test||This analysis applies only to comparison of baseline and exacerbation for ProAir||||0.0020
72388474|NCT04997304|144285133|OTHER|Test of paired differences||||||0.0008|||||||t-test, 2 sided|Paired t-test||This analysis applies only to comparison of baseline and exacerbation for AirDuo||||0.0008
72388475|NCT04997304|144285133|OTHER|Test of paired differences||||||0.0003|||||||t-test, 2 sided|Paired t-test||This analysis applies only to comparison of baseline and exacerbation for ProAir||||0.0003
72388476|NCT04997304|144285134|OTHER|Test of paired differences||||||0.04|||||||t-test, 2 sided|Paired t-test||This analysis applies only to comparison of baseline and exacerbation for AirDuo||||0.04
72388477|NCT04997304|144285134|OTHER|Test of paired differences||||||0.0965|||||||t-test, 2 sided|Paired t-test||This analysis applies only to comparison of baseline and exacerbation for ProAir||||0.0965
72619144|NCT01550965|144769020|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.56|||<|0.001|TWO_SIDED|95.0|-20.0|-13.12|||Paired t-test, 2 sided|||Statistical analysis for mean change in WPAI-SHP: percentage of impairment while working from week 0 to week 2.||-13.12|-20.00|<0.001
72388478|NCT06934993|144285147|SUPERIORITY||||||<|0.001||||||Statistical significance was defined as cases where the p-value was below 0.05.|Chi-squared|||In LIMA-LAD cases, when the post hoc power analysis results for the relationship between graft patency and flow rate were examined, the effect size was found to be 0.836, with an alpha error level set at 0.05. The statistical power of the study was determined to be 99.99%.||||<0.001
72388479|NCT06934993|144285148|SUPERIORITY|||||||0.001||||||Statistical significance was defined as cases where the p-value was below 0.05.|Chi-squared|||In all cases, when the post hoc power analysis results for the relationship between graft patency and flow rate were examined, the effect size was found to be 0.836, with an alpha error level set at 0.05. The statistical power of the study was determined to be 99.99%.||||0.001
72388480|NCT06934993|144285148|SUPERIORITY|||||||0.096||||||Statistical significance was defined as cases where the p-value was below 0.05.|Chi-squared|||In LIMA-LAD cases, when the post hoc power analysis results for the relationship between graft patency and flow rate were examined, the effect size was found to be 0.836, with an alpha error level set at 0.05. The statistical power of the study was determined to be 99.99%.||||0.096
72388481|NCT06934993|144285148|SUPERIORITY||||||<|0.001||||||Statistical significance was defined as cases where the p-value was below 0.05.|Chi-squared|||In LIMA-LAD cases, when the post hoc power analysis results for the relationship between graft patency and flow rate were examined, the effect size was found to be 0.836, with an alpha error level set at 0.05. The statistical power of the study was determined to be 99.99%.||||<0.001
72443081|NCT02638337|144399393|SUPERIORITY||Odds Ratio (OR)|2.23|||<|0.0001|TWO_SIDED|95.0|1.62|3.06|||Generalized estimating equations model|GEE model with treatment, week, treatment by week interaction, and study center as fixed effects and baseline severity of dryness as a covariate.|Odds ratio is the exponential of the mean of cumulative log odds ratio.|For the MBS of vaginal dryness a generalized estimating equations (GEE) model was used to fit a marginal proportional odds model to the longitudinal ordered categorical data, with repeated measurements of the change from baseline as the response variable; treatment, week, treatment by week interaction, and study center as fixed effects; and baseline severity of dryness modeled as a covariate.||3.06|1.62|<0.0001
72619145|NCT01550965|144769020|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-22.95|||<|0.001|TWO_SIDED|95.0|-26.93|-18.97|||Paired t-test, 2 sided|||Statistical analysis for mean change in WPAI-SHP: percentage of impairment while working from week 0 to week 8.||-18.97|-26.93|<0.001
72388482|NCT06934993|144285149|SUPERIORITY|||||||0.001||||||Statistical significance was defined as cases where the p-value was below 0.05.|Chi-squared|||In LIMA-LAD cases, when the post hoc power analysis results for the relationship between graft patency and flow rate were examined, the effect size was found to be 0.836, with an alpha error level set at 0.05. The statistical power of the study was determined to be 99.99%.||||0.001
72388483|NCT06934993|144285149|SUPERIORITY|||||||0.096||||||Statistical significance was defined as cases where the p-value was below 0.05.|Chi-squared|||In LIMA-LAD cases, when the post hoc power analysis results for the relationship between graft patency and flow rate were examined, the effect size was found to be 0.836, with an alpha error level set at 0.05. The statistical power of the study was determined to be 99.99%.||||0.096
72388484|NCT06934993|144285150|SUPERIORITY|||||||0.04||||||Statistical significance was defined as cases where the p-value was below 0.05.|Chi-squared|||In LIMA-LAD cases, when the post hoc power analysis results for the relationship between graft patency and flow rate were examined, the effect size was found to be 0.836, with an alpha error level set at 0.05. The statistical power of the study was determined to be 99.99%.||||0.04
72388485|NCT06934993|144285150|SUPERIORITY|||||||0.679||||||Statistical significance was defined as cases where the p-value was below 0.05.|Chi-squared|||In LIMA-LAD cases, when the post hoc power analysis results for the relationship between graft patency and flow rate were examined, the effect size was found to be 0.836, with an alpha error level set at 0.05. The statistical power of the study was determined to be 99.99%.||||0.679
72388486|NCT06934993|144285150|SUPERIORITY|||||||0.011||||||Statistical significance was defined as cases where the p-value was below 0.05.|Chi-squared|||In LIMA-LAD cases, when the post hoc power analysis results for the relationship between graft patency and flow rate were examined, the effect size was found to be 0.836, with an alpha error level set at 0.05. The statistical power of the study was determined to be 99.99%.||||0.011
72388487|NCT04092582|144285163|SUPERIORITY||Hazard Ratio (HR)|0.9||||0.6835|TWO_SIDED|95.0|0.55|1.47|||Regression, Cox|||||1.47|0.55|0.6835
72388488|NCT04092582|144285164|SUPERIORITY||Rate Ratio|1.0989||||0.7648|TWO_SIDED|95.0|0.5925|2.0381|||Poisson regression|||||2.0381|0.5925|0.7648
72388489|NCT04092582|144285165|SUPERIORITY||Hazard Ratio (HR)|0.81||||0.5248|TWO_SIDED|95.0|0.43|1.54|||Regression, Cox|||||1.54|0.43|0.5248
72388490|NCT04092582|144285166|SUPERIORITY|||||||0.125|||||||Mixed model for repeated measures (MMRM)|||||||0.1250
72388491|NCT04092582|144285167|SUPERIORITY|||||||0.2249|||||||Mixed model for repeated measures (MMRM)|||||||0.2249
72388492|NCT04092582|144285168|SUPERIORITY|||||||0.9693|||||||Mixed model for repeated measures (MMRM)|||||||0.9693
72388493|NCT04092582|144285169|SUPERIORITY|||||||0.9855|||||||Mixed model for repeated measures (MMRM)|||||||0.9855
72388494|NCT00739674|144285240|SUPERIORITY_OR_OTHER_LEGACY|||||||0.118||95.0|||||Fisher Exact|||||||0.118
72388495|NCT00739674|144285241|SUPERIORITY_OR_OTHER_LEGACY|||||||0.092||95.0|||||Fisher Exact|||||||0.092
72388496|NCT00739674|144285242|SUPERIORITY_OR_OTHER_LEGACY|||||||0.122||95.0|||||Fisher Exact|||||||0.122
72388497|NCT00739674|144285243|SUPERIORITY_OR_OTHER_LEGACY|||||||0.434||95.0|||||Fisher Exact|||||||0.434
72388498|NCT00739674|144285244|SUPERIORITY_OR_OTHER_LEGACY|||||||0.507||95.0|||||Regression, Linear|Adjusted for study medication, age, gender, race, cardiovascular risk, baseline weight, and baseline waist circumference.||||||0.507
72388499|NCT00739674|144285245|SUPERIORITY_OR_OTHER_LEGACY|||||||0.058||95.0|||||Regression, Linear|Adjusted for study medication, age, gender, race, cardiovascular risk, baseline weight, and baseline waist circumference.||||||0.058
72443082|NCT02638337|144399395|SUPERIORITY||LS Mean Difference|-21.6|||<|0.0001|TWO_SIDED|95.0|-25.2|-18.0|||Mixed-effects model repeated measures|MMRM model with treatment, week, treatment by week interaction, and study center as fixed effects; and baseline value modeled as a covariate.||Week 4||-18.0|-25.2|<0.0001
72443083|NCT02638337|144399395|SUPERIORITY||LS Mean Difference|-21.8|||<|0.0001|TWO_SIDED|95.0|-25.4|-18.1|||Mixed-effects model repeated measures|MMRM model with treatment, week, treatment by week interaction, and study center as fixed effects; and baseline value modeled as a covariate.||Week 8||-18.1|-25.4|<0.0001
72443084|NCT02638337|144399396|SUPERIORITY||LS Mean Difference|5.8|||<|0.0001|TWO_SIDED|95.0|4.2|7.3|||Mixed-effects model repeated measures|MMRM model with treatment, week, treatment by week interaction, and study center as fixed effects; and baseline value modeled as a covariate.||Week 4||7.3|4.2|<0.0001
72443085|NCT02638337|144399396|SUPERIORITY||LS Mean Difference|7.2|||<|0.0001|TWO_SIDED|95.0|5.5|9.0|||Mixed-effects model repeated measures|MMRM model with treatment, week, treatment by week interaction, and study center as fixed effects; and baseline value modeled as a covariate.||Week 8||9.0|5.5|<0.0001
72443086|NCT02638337|144399397|SUPERIORITY||LS Mean Difference|-0.58|||<|0.0001|TWO_SIDED|95.0|-0.69|-0.46|||Mixed-effects model repeated measures|MMRM model with treatment, week, treatment by week interaction, and study center as fixed effects; and baseline value modeled as a covariate.||Week 4||-0.46|-0.69|<0.0001
72443087|NCT02638337|144399397|SUPERIORITY||LS Mean Difference|-0.63|||<|0.0001|TWO_SIDED|95.0|-0.75|-0.51|||Mixed-effects model repeated measures|MMRM model with treatment, week, treatment by week interaction, and study center as fixed effects; and baseline value modeled as a covariate.||Week 8||-0.51|-0.75|<0.0001
72443088|NCT02638337|144399398|SUPERIORITY||Odds Ratio (OR)|1.74||||0.0005|TWO_SIDED|95.0|1.27|2.36|||Generalized estimating equations model|GEE model with treatment, week, treatment by week interaction, and study center as fixed effects and baseline severity of dryness as a covariate.|Odds ratio is the exponential of the mean of cumulative log odds ratio.|Week 4||2.36|1.27|0.0005
72496691|NCT01162421|144522797|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.4|STANDARD_ERROR_OF_MEAN|6.31||0.598|TWO_SIDED|95.0|-16.1|9.4||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 9||9.4|-16.1|0.598
72622369|NCT05524948|144774640|OTHER||Adjusted Mean Difference|-105.39|STANDARD_ERROR_OF_MEAN|24.57|<|0.0001|TWO_SIDED|95.0|-154.15|-56.62|||ANCOVA|Analysis was performed using ANCOVA model with study product and gender as a factor and baseline concentration as a covariate.|For Methanethiol|||-56.62|-154.15|<0.0001
72443089|NCT02638337|144399398|SUPERIORITY||Odds Ratio (OR)|2.01|||<|0.0001|TWO_SIDED|95.0|1.47|2.74|||Generalized estimating equations model|GEE model with treatment, week, treatment by week interaction, and study center as fixed effects and baseline severity of dryness as a covariate.|Odds ratio is the exponential of the mean of cumulative log odds ratio.|Week 8||2.74|1.47|<0.0001
72443090|NCT02638337|144399399|SUPERIORITY||Odds Ratio (OR)|0.89||||0.6263|TWO_SIDED|95.0|0.55|1.43|||Generalized estimating equations model|GEE model with treatment, week, treatment by week interaction, and study center as fixed effects and baseline severity of dryness as a covariate.|Odds ratio is the exponential of the mean of cumulative log odds ratio.|Week 4||1.43|0.55|0.6263
72443091|NCT02638337|144399399|SUPERIORITY||Odds Ratio (OR)|1.07||||0.7869|TWO_SIDED|95.0|0.66|1.75|||Generalized estimating equations model|GEE model with treatment, week, treatment by week interaction, and study center as fixed effects and baseline severity of dryness as a covariate.|Odds ratio is the exponential of the mean of cumulative log odds ratio.|Week 8||1.75|0.66|0.7869
72443092|NCT02638337|144399399|SUPERIORITY||Odds Ratio (OR)|1.03||||0.8894|TWO_SIDED|95.0|0.65|1.64|||Generalized estimating equations model|GEE model with treatment, week, treatment by week interaction, and study center as fixed effects and baseline severity of dryness as a covariate.|Odds ratio is the exponential of the mean of cumulative log odds ratio.|Week 12||1.64|0.65|0.8894
72443093|NCT02638337|144399400|SUPERIORITY||Odds Ratio (OR)|0.92||||0.8369|TWO_SIDED|95.0|0.4|2.1|||Generalized estimating equations model|GEE model with treatment, week, treatment by week interaction, and study center as fixed effects and baseline severity of dryness as a covariate.|Odds ratio is the exponential of the mean of cumulative log odds ratio.|Week 4||2.10|0.40|0.8369
72443094|NCT02638337|144399400|SUPERIORITY||Odds Ratio (OR)|1.51||||0.397|TWO_SIDED|95.0|0.58|3.95|||Generalized estimating equations model|GEE model with treatment, week, treatment by week interaction, and study center as fixed effects and baseline severity of dryness as a covariate.|Odds ratio is the exponential of the mean of cumulative log odds ratio.|Week 8||3.95|0.58|0.3970
72443095|NCT02638337|144399400|SUPERIORITY||Odds Ratio (OR)|1.33||||0.5391|TWO_SIDED|95.0|0.54|3.26|||Generalized estimating equations model|GEE model with treatment, week, treatment by week interaction, and study center as fixed effects and baseline severity of dryness as a covariate.|Odds ratio is the exponential of the mean of cumulative log odds ratio.|Week 12||3.26|0.54|0.5391
72443096|NCT02638337|144399401|SUPERIORITY||Odds Ratio (OR)|1.65||||0.0095|TWO_SIDED|95.0|1.13|2.4|||Generalized estimating equations model|GEE model with treatment, week, treatment by week interaction, and study center as fixed effects and baseline severity of dryness as a covariate.|Odds ratio is the exponential of the mean of cumulative log odds ratio.|Week 4||2.40|1.13|0.0095
72443097|NCT02638337|144399401|SUPERIORITY||Odds Ratio (OR)|1.45||||0.0542|TWO_SIDED|95.0|0.99|2.11|||Generalized estimating equations model|GEE model with treatment, week, treatment by week interaction, and study center as fixed effects and baseline severity of dryness as a covariate.|Odds ratio is the exponential of the mean of cumulative log odds ratio.|Week 8||2.11|0.99|0.0542
72443098|NCT02638337|144399401|SUPERIORITY||Odds Ratio (OR)|1.97||||0.0004|TWO_SIDED|95.0|1.35|2.88|||Generalized estimating equations model|GEE model with treatment, week, treatment by week interaction, and study center as fixed effects and baseline severity of dryness as a covariate.|Odds ratio is the exponential of the mean of cumulative log odds ratio.|Week 12||2.88|1.35|0.0004
72443099|NCT02638337|144399402|SUPERIORITY||Odds Ratio (OR)|0.71||||0.4336|TWO_SIDED|95.0|0.3|1.67|||Generalized estimating equations model|GEE model with treatment, week, treatment by week interaction, and study center as fixed effects and baseline severity of dryness as a covariate.|Odds ratio is the exponential of the mean of cumulative log odds ratio.|Week 4||1.67|0.30|0.4336
72443100|NCT02638337|144399402|SUPERIORITY||Odds Ratio (OR)|0.88||||0.7672|TWO_SIDED|95.0|0.37|2.08|||Generalized estimating equations model|GEE model with treatment, week, treatment by week interaction, and study center as fixed effects and baseline severity of dryness as a covariate.|Odds ratio is the exponential of the mean of cumulative log odds ratio.|Week 8||2.08|0.37|0.7672
72443101|NCT02638337|144399402|SUPERIORITY||Odds Ratio (OR)|0.86||||0.7101|TWO_SIDED|95.0|0.39|1.89|||Generalized estimating equations model|GEE model with treatment, week, treatment by week interaction, and study center as fixed effects and baseline severity of dryness as a covariate.|Odds ratio is the exponential of the mean of cumulative log odds ratio.|Week 12||1.89|0.39|0.7101
72443102|NCT02638337|144399403|SUPERIORITY||LS Mean Difference|13.98|||<|0.0001|TWO_SIDED|95.0|11.85|16.12|||ANCOVA|The ANCOVA model included treatment group as a fixed effect and baseline value as a covariate.||Week 4||16.12|11.85|<0.0001
72443103|NCT02638337|144399403|SUPERIORITY||LS Mean Difference|14.73|||<|0.0001|TWO_SIDED|95.0|12.5|16.96|||ANCOVA|The ANCOVA model included treatment group as a fixed effect and baseline value as a covariate.||Week 8||16.96|12.50|<0.0001
72443104|NCT02638337|144399403|SUPERIORITY||LS Mean Difference|14.91|||<|0.0001|TWO_SIDED|95.0|12.55|17.28|||ANCOVA|The ANCOVA model included treatment group as a fixed effect and baseline value as a covariate.||Week 12||17.28|12.55|<0.0001
72443105|NCT02638337|144399404|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||Week 4||||<0.0001
72443106|NCT02638337|144399404|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||Week 8||||<0.0001
72443107|NCT02638337|144399404|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||Week 12||||<0.0001
72443108|NCT02638337|144399405|SUPERIORITY||LS Mean Difference|2.5|||<|0.0001|TWO_SIDED|95.0|2.0|3.0|||ANCOVA|The ANCOVA model included treatment group as a fixed effect and baseline value as a covariate.||Week 4||3.0|2.0|<0.0001
72443109|NCT02638337|144399405|SUPERIORITY||LS Mean Difference|2.9|||<|0.0001|TWO_SIDED|95.0|2.4|3.4|||ANCOVA|The ANCOVA model included treatment group as a fixed effect and baseline value as a covariate.||Week 8||3.4|2.4|<0.0001
72443110|NCT02638337|144399405|SUPERIORITY||LS Mean Difference|2.8|||<|0.0001|TWO_SIDED|95.0|2.2|3.4|||ANCOVA|The ANCOVA model included treatment group as a fixed effect and baseline value as a covariate.||Week 12||3.4|2.2|<0.0001
72559836|NCT01942135|144650106|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.2||||0.875|TWO_SIDED|95.0|-2.6|2.2||The priori threshold for statistical significance is 2-sided alpha=0.05. The p-value was not adjusted for multiple comparisons.|Mixed Model Analysis (2-sided)|Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.||Statistical significance for palbociclib plus fulvestrant vs placebo plus fulvestrant for arm symptoms||2.2|-2.6|0.8750
72496692|NCT01162421|144522797|SUPERIORITY_OR_OTHER||LS Mean Difference|3.4|STANDARD_ERROR_OF_MEAN|5.75||0.558|TWO_SIDED|95.0|-8.2|15.0||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 12||15.0|-8.2|0.558
72496693|NCT01162421|144522797|SUPERIORITY_OR_OTHER||LS Mean Difference|2.7|STANDARD_ERROR_OF_MEAN|6.4||0.669|TWO_SIDED|95.0|-10.1|15.6||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 18||15.6|-10.1|0.669
72496694|NCT01162421|144522797|SUPERIORITY_OR_OTHER||LS Mean Difference|1.1|STANDARD_ERROR_OF_MEAN|6.16||0.865|TWO_SIDED|95.0|-11.3|13.5||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 24||13.5|-11.3|0.865
72496695|NCT01162421|144522798|SUPERIORITY_OR_OTHER||LS Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.058||0.809|TWO_SIDED|95.0|-0.1|0.13||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 3||0.13|-0.10|0.809
72496696|NCT01162421|144522798|SUPERIORITY_OR_OTHER||LS Mean Difference|0.05|STANDARD_ERROR_OF_MEAN|0.062||0.447|TWO_SIDED|95.0|-0.08|0.17||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 6||0.17|-0.08|0.447
72559837|NCT01942135|144650106|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|8.9||||0.0255|TWO_SIDED|95.0|1.1|16.6||The priori threshold for statistical significance is 2-sided alpha=0.05. The p-value was not adjusted for multiple comparisons.|Mixed Model Analysis (2-sided)|Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.||Statistical significance for palbociclib plus fulvestrant vs placebo plus fulvestrant for upset by hair loss||16.6|1.1|0.0255
72559838|NCT01942135|144650107|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.037||||0.0308|TWO_SIDED|95.0|0.0|0.07||The priori threshold for statistical significance is 2-sided alpha=0.05. The p-value was not adjusted for multiple comparisons.|Mixed Model Analysis (2-sided)|Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.||Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.||0.07|0.00|0.0308
72496697|NCT01162421|144522798|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.062||0.579|TWO_SIDED|95.0|-0.16|0.09||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 9||0.09|-0.16|0.579
72496698|NCT01162421|144522798|SUPERIORITY_OR_OTHER||LS Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.057||0.922|TWO_SIDED|95.0|-0.11|0.12||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 12||0.12|-0.11|0.922
72496699|NCT01162421|144522798|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.064||0.894|TWO_SIDED|95.0|-0.14|0.12||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 18||0.12|-0.14|0.894
72496700|NCT01162421|144522798|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.07||0.611|TWO_SIDED|95.0|-0.17|0.1||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 24||0.10|-0.17|0.611
72496701|NCT01162421|144522799|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.5|STANDARD_ERROR_OF_MEAN|4.42||0.572|TWO_SIDED|95.0|-11.3|6.3||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 3||6.3|-11.3|0.572
72496702|NCT01162421|144522799|SUPERIORITY_OR_OTHER||LS Mean Difference|7.9|STANDARD_ERROR_OF_MEAN|5.15||0.13|TWO_SIDED|95.0|-2.4|18.2||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 6||18.2|-2.4|0.130
72496703|NCT01162421|144522799|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.4|STANDARD_ERROR_OF_MEAN|5.26||0.649|TWO_SIDED|95.0|-12.9|8.1||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 9||8.1|-12.9|0.649
72496704|NCT01162421|144522799|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.7|STANDARD_ERROR_OF_MEAN|4.8||0.579|TWO_SIDED|95.0|-12.3|6.9||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 12||6.9|-12.3|0.579
72559839|NCT01942135|144650108|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.8||||0.5523|TWO_SIDED|95.0|-1.9|3.5||The priori threshold for statistical significance is 2-sided alpha=0.05. The p-value was not adjusted for multiple comparisons.|Mixed Model Analysis (2-sided)|Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.||Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.||3.5|-1.9|0.5523
72496705|NCT01162421|144522799|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|5.03||0.826|TWO_SIDED|95.0|-11.1|8.9||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 18||8.9|-11.1|0.826
72496706|NCT01162421|144522799|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.4|STANDARD_ERROR_OF_MEAN|5.72||0.675|TWO_SIDED|95.0|-13.8|9.0||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 24||9.0|-13.8|0.675
72496707|NCT01162421|144522800|SUPERIORITY_OR_OTHER||LS Mean Difference|1.2|STANDARD_ERROR_OF_MEAN|1.57||0.458|TWO_SIDED|95.0|-2.0|4.3||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 3||4.3|-2.0|0.458
72619146|NCT01550965|144769020|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-21.68|||<|0.001|TWO_SIDED|95.0|-25.69|-17.67|||Paired t-test, 2 sided|||Statistical analysis for mean change in WPAI-SHP: percentage of impairment while working from week 0 to week 18. Efficacy assessments were not specified at week 18; missing data at week 18 were imputed using last observation carried forward (LOCF).||-17.67|-25.69|<0.001
72443111|NCT02638337|144399406|SUPERIORITY||LS Mean Difference|-0.8||||0.0002|TWO_SIDED|95.0|-1.3|-0.4|||ANCOVA|The ANCOVA model included treatment group as a fixed effect and baseline value as a covariate.||Week 4||-0.4|-1.3|0.0002
72443112|NCT02638337|144399406|SUPERIORITY||LS Mean Difference|-1.1|||<|0.0001|TWO_SIDED|95.0|-1.5|-0.6|||ANCOVA|The ANCOVA model included treatment group as a fixed effect and baseline value as a covariate.||Week 8||-0.6|-1.5|<0.0001
72443113|NCT02638337|144399406|SUPERIORITY||LS Mean Difference|-1.2|||<|0.0001|TWO_SIDED|95.0|-1.6|-0.7|||ANCOVA|The ANCOVA model included treatment group as a fixed effect and baseline value as a covariate.||Week 12||-0.7|-1.6|<0.0001
72443114|NCT02638337|144399407|SUPERIORITY||LS Mean Difference|-1.0||||0.0118|TWO_SIDED|95.0|-1.8|-0.2|||ANCOVA|The ANCOVA model included treatment group as a fixed effect and baseline value as a covariate.||||-0.2|-1.8|0.0118
72443115|NCT02638337|144399408|SUPERIORITY||LS Mean Difference|0.02||||0.9748|TWO_SIDED|95.0|-1.17|1.2|||ANCOVA|The ANCOVA model included treatment group as a fixed effect and baseline value as a covariate.||Week 4||1.20|-1.17|0.9748
72443116|NCT02638337|144399408|SUPERIORITY||LS Mean Difference|0.19||||0.7865|TWO_SIDED|95.0|-1.18|1.56|||ANCOVA|The ANCOVA model included treatment group as a fixed effect and baseline value as a covariate.||Week 8||1.56|-1.18|0.7865
72443117|NCT02638337|144399408|SUPERIORITY||LS Mean Difference|1.59||||0.0392|TWO_SIDED|95.0|0.08|3.09|||ANCOVA|The ANCOVA model included treatment group as a fixed effect and baseline value as a covariate.||Week 12||3.09|0.08|0.0392
72443118|NCT02638337|144399409|SUPERIORITY||LS Mean Difference|0.16||||0.0752|TWO_SIDED|95.0|-0.02|0.34|||ANCOVA|The ANCOVA model included treatment group as a fixed effect and baseline value as a covariate.||Desire||0.34|-0.02|0.0752
72443119|NCT02638337|144399409|SUPERIORITY||LS Mean Difference|0.2||||0.1867|TWO_SIDED|95.0|-0.1|0.49|||ANCOVA|The ANCOVA model included treatment group as a fixed effect and baseline value as a covariate.||Arousal||0.49|-0.10|0.1867
72443120|NCT02638337|144399409|SUPERIORITY||LS Mean Difference|0.4||||0.0161|TWO_SIDED|95.0|0.07|0.73|||ANCOVA|The ANCOVA model included treatment group as a fixed effect and baseline value as a covariate.||Lubrication||0.73|0.07|0.0161
72443121|NCT02638337|144399409|SUPERIORITY||LS Mean Difference|0.16||||0.34|TWO_SIDED|95.0|-0.16|0.48|||ANCOVA|The ANCOVA model included treatment group as a fixed effect and baseline value as a covariate.||Orgasm||0.48|-0.16|0.3400
72443122|NCT02638337|144399409|SUPERIORITY||LS Mean Difference|0.16||||0.2195|TWO_SIDED|95.0|-0.1|0.41|||ANCOVA|The ANCOVA model included treatment group as a fixed effect and baseline value as a covariate.||Satisfaction||0.41|-0.10|0.2195
72443123|NCT02638337|144399409|SUPERIORITY||LS Mean Difference|0.45||||0.0103|TWO_SIDED|95.0|0.11|0.8|||ANCOVA|The ANCOVA model included treatment group as a fixed effect and baseline value as a covariate.||Pain||0.80|0.11|0.0103
72443124|NCT02638337|144399410|SUPERIORITY||LS Mean Difference|0.1||||0.723|TWO_SIDED|95.0|-0.4|0.6|||ANCOVA|The ANCOVA model included treatment group as a fixed effect and baseline value as a covariate.||Week 4||0.6|-0.4|0.7230
72496708|NCT01162421|144522800|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.4|STANDARD_ERROR_OF_MEAN|1.76||0.419|TWO_SIDED|95.0|-4.9|2.1||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 6||2.1|-4.9|0.419
72443125|NCT02638337|144399410|SUPERIORITY||LS Mean Difference|0.4||||0.1104|TWO_SIDED|95.0|-0.1|0.9|||ANCOVA|The ANCOVA model included treatment group as a fixed effect and baseline value as a covariate.||Week 8||0.9|-0.1|0.1104
72443126|NCT02638337|144399410|SUPERIORITY||LS Mean Difference|0.3||||0.2448|TWO_SIDED|95.0|-0.2|0.9|||ANCOVA|The ANCOVA model included treatment group as a fixed effect and baseline value as a covariate.||Week 12||0.9|-0.2|0.2448
72443127|NCT02638337|144399411|SUPERIORITY||LS Mean Difference|-4388.3||||0.4263|TWO_SIDED|95.0|-15214.8|6438.3|||ANCOVA|The ANCOVA model included treatment group as a fixed effect and baseline value as a covariate.||||6438.3|-15214.8|0.4263
72443128|NCT02638337|144399412|SUPERIORITY||LS Mean Difference|-0.049|||<|0.0001|TWO_SIDED|95.0|-0.071|-0.027|||ANCOVA|The ANCOVA model included treatment group as a fixed effect and baseline value as a covariate.||||-0.027|-0.071|<0.0001
72443129|NCT02638337|144399413|SUPERIORITY||LS Mean Difference|-0.14||||0.5159|TWO_SIDED|95.0|-0.58|0.29|||ANCOVA|The ANCOVA model included treatment group as a fixed effect and baseline value as a covariate.||||0.29|-0.58|0.5159
72443130|NCT02638337|144399414|SUPERIORITY||LS Mean Difference|-0.75||||0.0227|TWO_SIDED|95.0|-1.39|-0.1|||ANCOVA|The ANCOVA model included treatment group as a fixed effect and baseline value as a covariate.||||-0.10|-1.39|0.0227
72443131|NCT02638337|144399415|SUPERIORITY||LS Mean Difference|-0.22||||0.0003|TWO_SIDED|95.0|-0.34|-0.1|||ANCOVA|The ANCOVA model included treatment group as a fixed effect and baseline value as a covariate.||||-0.10|-0.34|0.0003
72443132|NCT02638337|144399416|SUPERIORITY||LS Mean Difference|-6.2|||<|0.0001|TWO_SIDED|95.0|-8.1|-4.3|||ANCOVA|The ANCOVA model included treatment group as a fixed effect and baseline value as a covariate.||||-4.3|-8.1|<0.0001
72443133|NCT02638337|144399417|SUPERIORITY||LS Mean Difference|-1.35||||0.0084|TWO_SIDED|95.0|-2.35|-0.35|||ANCOVA|The ANCOVA model included treatment group as a fixed effect and baseline value as a covariate.||||-0.35|-2.35|0.0084
72443134|NCT02638337|144399418|SUPERIORITY||LS Mean Difference|-2.06|||<|0.0001|TWO_SIDED|95.0|-2.92|-1.19|||ANCOVA|The ANCOVA model included treatment group as a fixed effect and baseline value as a covariate.||||-1.19|-2.92|<0.0001
72443135|NCT02638337|144399419|SUPERIORITY||LS Mean Difference|-5.26|||<|0.0001|TWO_SIDED|95.0|-7.64|-2.89|||ANCOVA|The ANCOVA model included treatment group as a fixed effect and baseline value as a covariate.||||-2.89|-7.64|<0.0001
72443136|NCT02638337|144399420|SUPERIORITY|||||||0.9575|||||||Welch's t-test|||||||0.9575
72443137|NCT02638337|144399421|SUPERIORITY|||||||0.8772|||||||Welch's t-test|||||||0.8772
72443138|NCT02638337|144399422|SUPERIORITY|||||||0.0007|||||||Wilcoxon rank-sum test|||||||0.0007
72443139|NCT01340066|144399429|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.92|ONE_SIDED|80.0|||||Chi-squared|||||||.92
72559840|NCT01942135|144650109|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.642|||<|0.001|TWO_SIDED|95.0|0.487|0.846||The priori threshold for statistical significance is 1-sided alpha=0.025. The p-value was not adjusted for multiple comparisons.|Unstratified log-rank test (1-sided)|1-sided p-value from the unstratified log-rank test.|Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of the palbociclib plus fulvestrant arm.|Treatment with palbociclib plus fulvestrant significantly delayed TTD in pain symptom compared with placebo plus fulvestrant for unstratified analysis.||0.846|0.487|<0.001
72559841|NCT00950300|144650113|NON_INFERIORITY|Non-inferiority was concluded if the lower limit of the 90% confidence interval (CI) was greater than or equal to (≥) 0.8 for the geometric mean ratio.|Geometric mean ratio|1.33|||||TWO_SIDED|90.0|1.24|1.44|||||Ratio of test treatment group (Herceptin SC + Chemotherapy) to reference treatment group (Herceptin IV + Chemotherapy).|PK sample size calculations based on percentage of coefficient of variation (CV%) for Ctrough of trastuzumab from previous metastatic breast cancer (MBC) and early breast cancer (EBC) studies. Because pre-surgery situation was comparable to MBC setting, interpatient CV% of 60 percent (%) was assumed and 130 participants per arm (260 participants total) were needed to demonstrate Ctrough comparability with 80% power if the true means of the two formulations did not differ by greater than (\>) 5%.||1.44|1.24|
72559842|NCT00950300|144650114|NON_INFERIORITY|Non-inferiority was concluded if the lower limit of the one-sided 97.5% CI was above -12.5% for the difference in response (pCR) rates.|Difference in response rates|4.7|||||ONE_SIDED|97.5|-4.0||||||The one-sided 97.5% CI for the difference in response (pCR) rates was calculated using the Anderson-Hauck continuity correction.|Assuming pCR rates of at least 40% in both arms, 552 participants were necessary to conclude non-inferiority in pCR rate with a power of 80% using a one-sided 97.5% CI for the difference of the response rates and a non-inferiority margin of 12.5%.|||-4.0|
72559843|NCT00950300|144650115|OTHER||Geometric mean ratio|1.51|||||TWO_SIDED|90.0|1.4|1.63|||||Ratio of test treatment group (Herceptin SC + Chemotherapy) to reference treatment group (Herceptin IV + Chemotherapy).|Additional supportive analysis.||1.63|1.40|
72559844|NCT00950300|144650116|OTHER||Geometric mean ratio|1.55|||||TWO_SIDED|90.0|1.46|1.64|||||Ratio of test treatment group (Herceptin SC + Chemotherapy) to reference treatment group (Herceptin IV + Chemotherapy).|Additional supportive analysis.||1.64|1.46|
72388500|NCT00739674|144285246|SUPERIORITY_OR_OTHER_LEGACY|||||||0.158||95.0|||||Regression, Linear|Adjusted for study medication, age, gender, race, cardiovascular risk, baseline weight, and baseline waist circumference.||||||0.158
72559845|NCT00950300|144650117|OTHER||Geometric mean ratio|1.55|||||TWO_SIDED|90.0|1.45|1.64|||||Ratio of test treatment group (Herceptin SC + Chemotherapy) to reference treatment group (Herceptin IV + Chemotherapy).|Additional supportive analysis.||1.64|1.45|
72559846|NCT00950300|144650126|OTHER||Difference in response rates|5.01|||||TWO_SIDED|95.0|-3.5|13.5|||||The 95% CI for the difference in response (tpCR) rates was calculated using the Anderson-Hauck continuity correction.|||13.5|-3.5|
72559847|NCT00950300|144650127|OTHER||Difference in response rates|-1.64|||||TWO_SIDED|95.0|-7.4|4.2|||||The 95% CI for the difference in response (CR+PR) rates was calculated using the Anderson-Hauck continuity correction.|||4.2|-7.4|
72559848|NCT00950300|144650127|OTHER||Odds Ratio (OR)|0.86|||||TWO_SIDED|95.0|0.5|1.46|||||OR of test treatment group (Herceptin SC + Chemotherapy) to reference treatment group (Herceptin IV + Chemotherapy).|||1.46|0.50|
72619147|NCT01550965|144769020|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-24.45|||<|0.001|TWO_SIDED|95.0|-28.33|-20.58|||Paired t-test, 2 sided|||Statistical analysis for mean change in WPAI-SHP: percentage of impairment while working from week 0 to week 26.||-20.58|-28.33|<0.001
72388501|NCT00739674|144285247|SUPERIORITY_OR_OTHER_LEGACY|||||||0.064||95.0|||||Regression, Linear|Adjusted for study medication, age, gender, race, cardiovascular risk, baseline weight, and baseline waist circumference.||||||0.064
72388502|NCT00739674|144285248|SUPERIORITY_OR_OTHER_LEGACY|||||||0.262||95.0|||||Regression, Linear|Adjusted for study medication, age, gender, race, cardiovascular risk, baseline weight, and baseline waist circumference.||||||0.262
72388503|NCT00739674|144285249|SUPERIORITY_OR_OTHER_LEGACY|||||||0.026||95.0|||||Regression, Linear|Adjusted for study medication, age, gender, race, cardiovascular risk, baseline weight, and baseline waist circumference.||||||0.026
72388504|NCT00739674|144285250|SUPERIORITY_OR_OTHER_LEGACY|||||||0.212||95.0|||||Log Rank|||||||0.212
72388505|NCT01594281|144285251|OTHER|The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.|Least Squares Mean Difference|-2.8||||0.0344|TWO_SIDED|95.0|-5.4|-0.2|||ANCOVA|||||-0.2|-5.4|0.0344
72388506|NCT01594281|144285251|OTHER|The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.|Least Squares Mean Difference|-1.2||||0.3809|TWO_SIDED|95.0|-3.8|1.5|||ANCOVA|||||1.5|-3.8|0.3809
72388507|NCT01594281|144285251|OTHER|The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.|Least Squares Mean Difference|1.7||||0.2113|TWO_SIDED|95.0|-1.0|4.3|||ANCOVA|||||4.3|-1.0|0.2113
72496709|NCT01162421|144522800|SUPERIORITY_OR_OTHER||LS Mean Difference|0.6|STANDARD_ERROR_OF_MEAN|1.42||0.692|TWO_SIDED|95.0|-2.3|3.4||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 9||3.4|-2.3|0.692
72388508|NCT01594281|144285252|OTHER|The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.|Least Squares Mean Difference|-2.4||||0.0081|TWO_SIDED|95.0|-4.2|-0.6|||ANCOVA|||||-0.6|-4.2|0.0081
72388509|NCT01594281|144285252|OTHER|The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.|Least Squares Mean Difference|-0.3||||0.7494|TWO_SIDED|95.0|-2.0|1.5|||ANCOVA|||||1.5|-2.0|0.7494
72388510|NCT01594281|144285252|OTHER|The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.|Least Squares Mean Difference|2.1||||0.0175|TWO_SIDED|95.0|0.4|3.9|||ANCOVA|||||3.9|0.4|0.0175
72388511|NCT01594281|144285253|OTHER|The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.|Least Squares Mean Difference|5.5||||0.0495|TWO_SIDED|95.0|0.0|11.0|||ANCOVA|||||11.0|0.0|0.0495
72559849|NCT00950300|144650130|OTHER||Hazard Ratio (HR)|0.98||||0.8651|TWO_SIDED|95.0|0.74|1.29|||Log Rank||HR of test treatment group (Herceptin SC + Chemotherapy) to reference treatment group (Herceptin IV + Chemotherapy).|||1.29|0.74|0.8651
72559850|NCT00950300|144650132|OTHER||Hazard Ratio (HR)|0.94||||0.7767|TWO_SIDED|95.0|0.61|1.45|||Log Rank||HR of test treatment group (Herceptin SC + Chemotherapy) to reference treatment group (Herceptin IV + Chemotherapy).|||1.45|0.61|0.7767
72559851|NCT00494013|144650136|NON_INFERIORITY_OR_EQUIVALENCE|The noninferiority margin was 0.4%.|Mean Difference (Net)|-0.21||||0.026||95.0|-0.39|-0.03|||ANCOVA|ANCOVA Model: Variable=Treatment + Baseline + Country + Baseline Sulfonylurea Group.|The two-sided 95% confidence interval is for the Least Squares Mean difference between the two treatments (Insulin Lispro Protamine Suspension minus Determir).|Hypothesis: Basal analog insulin lispro protamine suspension, injected once or twice daily is noninferior to basal analog insulin determir, injected once or twice daily, with regard to glycemic control as measured by change in HbA1c from baseline to endpoint (last observation carried forward).||-0.03|-0.39|0.026
72559852|NCT00494013|144650137|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.11||||0.213||95.0|-0.28|0.06||P-value for 12 Week Change from Baseline.|ANCOVA|ANCOVA Model: Variable = Treatment + Baseline + Country + Baseline Sulfonylurea Group.|The two-sides 95% confidence interval is for the Least Squares Mean difference between the two treatments (Insulin Lispro Protamine Suspension minus Detemir).|||0.06|-0.28|0.213
72559853|NCT00494013|144650137|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.11||||0.213||95.0|-0.28|0.06||P-value for 12 Week HbA1c.|ANCOVA|ANCOVA Model: Variable = Treatment + Baseline + Country + Baseline Sulfonylurea Group.|The two-sided 95% confidence interval is for the Least Squares Mean difference between the two treatments (Insulin Lispro Protamine Suspension minus Detemir).|||0.06|-0.28|0.213
72443140|NCT04238247|144399445|SUPERIORITY||Odds Ratio (OR)|1.876119||||0.006|TWO_SIDED|95.0|1.193531|2.949084||The threshold for statistical significance was p = 0.05.|Regression, Logistic|We conducted logistic regression adjusted for randomization strata (recommended CRS and reason for eligibility).||We hypothesized the intervention group would have greater child passenger safety guideline adherence at 6 months compared with enhanced usual care group. In planning the trial, we assumed 75% of TCBD caregivers would be re-randomized. Baseline randomization was stratified by recommended CRS (rear-facing seat, forward-facing seat, booster seat) and reason for eligibility (not using the recommended CRS at baseline or planning a premature transition in the next 6 months).||2.949084|1.193531|0.006
72443141|NCT04238247|144399446|SUPERIORITY||Odds Ratio (OR)|0.8686678||||0.671|TWO_SIDED|95.0|0.4535589|1.663695||The threshold for statistical significance was p = 0.05.|Regression, Logistic|||This analysis is limited to the Phase 2 participants who were re-randomized at 6 months to test the hypothesis that the enhanced intervention (with booster MI session) would have greater guideline adherent child passenger safety behaviors at 12 month follow-up than the group that continued in the basic intervention (mHealth components).||1.663695|0.4535589|0.671
72443142|NCT04238247|144399446|SUPERIORITY||Odds Ratio (OR)|6.859599|||<|0.001|TWO_SIDED|95.0|3.173121|14.82896|||Regression, Logistic|||||14.82896|3.173121|<0.001
72443143|NCT04238247|144399449|SUPERIORITY||Odds Ratio (OR)|1.74029||||0.032|TWO_SIDED|95.0|1.049169|2.886676||The threshold for statistical significance was p = 0.05.|Regression, Logistic|||||2.886676|1.049169|0.032
72443144|NCT04238247|144399450|SUPERIORITY||Odds Ratio (OR)|1.112874||||0.752|TWO_SIDED|95.0|0.5735782|2.159233||The threshold for statistical significance was p = 0.05.|Regression, Logistic|||||2.159233|0.5735782|0.752
72443145|NCT04238247|144399450|SUPERIORITY||Odds Ratio (OR)|7.959981|||<|0.001|TWO_SIDED|95.0|3.321933|19.07362|||Regression, Logistic|||||19.07362|3.321933|<0.001
72443146|NCT03092726|144399451|SUPERIORITY||LS Mean (LSM) Difference|0.06|STANDARD_ERROR_OF_MEAN|0.26||0.59|TWO_SIDED|90.0|-0.38|0.5||1-sided p-value is for comparison of ASP8062 30 mg with placebo from the above described MMRM model.|MMRM|||Differences of least squares (LS) means were calculated by subtracting the LS mean of placebo group from the LS mean of ASP8062 30 mg group using a mixed-effect, repeated measures (MMRM) model with change from baseline to each week from weeks 1 to 8 as response, treatment, center (pooled where necessary), time (study weeks 1 to 8) and treatment-by-time interaction as fixed effects, baseline and baseline-by-time interaction as covariates.||0.50|-0.38|0.590
72443147|NCT03092726|144399455|SUPERIORITY||Difference of percentages|-6.6||||0.874|TWO_SIDED|90.0|-18.7|5.7||1-sided p-value is for comparison of ASP8062 30 mg with placebo using Fisher's Exact method.|Fisher Exact|||Week 8: Differences of the percentages were calculated by subtracting the percentage of placebo group from the percentage of ASP8062 30 mg group. Confidence Interval (CI) for each treatment group and the difference of the percentages was an exact unconditional confidence interval based on Santner-Snell approach.||5.7|-18.7|0.874
72443148|NCT03092726|144399455|SUPERIORITY||Differences of percentages|-5.6||||0.838|TWO_SIDED|90.0|-17.7|6.7||1-sided p-value is for comparison of ASP8062 30 mg with placebo using Fisher's Exact method.|Fisher Exact|||EOT: Differences of the percentages were calculated by subtracting the percentage of placebo group from the percentage of ASP8062 30 mg group. Confidence Interval (CI) for each treatment group and the difference of the percentages was an exact unconditional confidence interval based on Santner-Snell approach.||6.7|-17.7|0.838
72443149|NCT03092726|144399456|SUPERIORITY||Differences of percentages|2.2||||0.412|TWO_SIDED|90.0|-10.0|14.4||1-sided p-value is for comparison of ASP8062 30 mg with placebo using Fisher's Exact method.|Fisher Exact|||Week 8: Differences of the percentages were calculated by subtracting the percentage of placebo group from the percentage of ASP8062 30 mg group. Confidence Interval (CI) for each treatment group and the difference of the percentages was an exact unconditional confidence interval based on Santner-Snell approach.||14.4|-10.0|0.412
72496710|NCT01162421|144522800|SUPERIORITY_OR_OTHER||LS Mean Difference|1.6|STANDARD_ERROR_OF_MEAN|1.69||0.357|TWO_SIDED|95.0|-1.8|5.0||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 12||5.0|-1.8|0.357
72559854|NCT00494013|144650137|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.2||||0.038||95.0|-0.38|-0.01||P-value for 24 Week Change from Baseline.|ANCOVA|ANCOVA Model: Variable = Treatment + Baseline + Country + Baseline Sulfonylurea Group.|The two-sides 95% confidence interval is for the Least Squares Mean difference between the two treatments (Insulin Lispro Protamine Suspension minus Detemir).|||-0.01|-0.38|0.038
72619148|NCT01550965|144769021|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-18.34|||<|0.001|TWO_SIDED|95.0|-22.1|-14.57|||Paired t-test, 2 sided|||Statistical analysis for mean change in WPAI-SHP: overall work impairment percentage from week 0 to week 2.||-14.57|-22.10|<0.001
72443150|NCT03092726|144399456|SUPERIORITY||Differences of percentages|4.3||||0.269|TWO_SIDED|90.0|-7.9|16.4||1-sided p-value is for comparison of ASP8062 30 mg with placebo using Fisher's Exact method.|Fisher Exact|||EOT: Differences of the percentages were calculated by subtracting the percentage of placebo group from the percentage of ASP8062 30 mg group. Confidence Interval (CI) for each treatment group and the difference of the percentages was an exact unconditional confidence interval based on Santner-Snell approach.||16.4|-7.9|0.269
72496711|NCT01162421|144522800|SUPERIORITY_OR_OTHER||LS Mean Difference|1.4|STANDARD_ERROR_OF_MEAN|1.67||0.42|TWO_SIDED|95.0|-2.0|4.7||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 18||4.7|-2.0|0.420
72496712|NCT01162421|144522800|SUPERIORITY_OR_OTHER||LS Mean Difference|1.4|STANDARD_ERROR_OF_MEAN|1.58||0.38|TWO_SIDED|95.0|-1.8|4.5||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 24||4.5|-1.8|0.380
72496713|NCT01162421|144522801|SUPERIORITY_OR_OTHER||LS Mean Difference|0.6|STANDARD_ERROR_OF_MEAN|0.28||0.046|TWO_SIDED|95.0|0.0|1.1||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|The a priori threshold for statistical significance is P=0.05.||Month 3||1.1|0.0|0.046
72496714|NCT01162421|144522801|SUPERIORITY_OR_OTHER||LS Mean Difference|0.8|STANDARD_ERROR_OF_MEAN|0.27||0.003|TWO_SIDED|95.0|0.3|1.3||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|The a priori threshold for statistical significance is P=0.01.||Month 6||1.3|0.3|0.003
72559855|NCT00494013|144650137|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.2||||0.038||95.0|-0.38|-0.01||P-value for Week 24 HbA1c.|ANCOVA|ANCOVA Model: Variable = Treatment + Baseline + Country + Baseline Sulfonylurea Group.|The two-sided 95% confidence interval is for the Least Squares Mean difference between the two treatments (Insulin Lispro Protamine Suspension minus Detemir).|||-0.01|-0.38|0.038
72559856|NCT00494013|144650138|SUPERIORITY_OR_OTHER|||||||0.463||95.0||||P-value for HbA1c \<7.0%.|Fisher Exact|||||||0.463
72559857|NCT00494013|144650138|SUPERIORITY_OR_OTHER|||||||0.135||95.0||||P-value for HbA1c ≤6.5%.|Fisher Exact|||||||0.135
72443151|NCT03092726|144399457|SUPERIORITY||LSM Difference|-0.68|STANDARD_ERROR_OF_MEAN|2.03||0.369|TWO_SIDED|90.0|-4.05|2.68||1-sided p-value is for comparison of ASP8062 30 mg with placebo from the above described MMRM model.|MMRM|||Week 2: Differences of LS means were calculated by subtracting the LS mean of placebo group from the LS mean of ASP8062 30 mg group using a MMRM model with change from baseline to weeks 2, 4 and 8 as response, treatment, center (pooled where necessary), time (study weeks 2, 4 and 8) and treatment-by-time interaction as fixed effects, baseline and baseline-by-time interaction as covariates.||2.68|-4.05|0.369
72443152|NCT03092726|144399457|SUPERIORITY||LSM Difference|-0.64|STANDARD_ERROR_OF_MEAN|2.34||0.393|TWO_SIDED|90.0|-4.51|3.24||1-sided p-value is for comparison of ASP8062 30 mg with placebo from the above described MMRM model.|MMRM|||Week 4: Differences of LS means were calculated by subtracting the LS mean of placebo group from the LS mean of ASP8062 30 mg group using a MMRM model with change from baseline to weeks 2, 4 and 8 as response, treatment, center (pooled where necessary), time (study weeks 2, 4 and 8) and treatment-by-time interaction as fixed effects, baseline and baseline-by-time interaction as covariates.||3.24|-4.51|0.393
72443153|NCT03092726|144399457|SUPERIORITY||LSM Difference|0.86|STANDARD_ERROR_OF_MEAN|2.68||0.626|TWO_SIDED|90.0|-3.57|5.3|||MMRM|||Week 8: Differences of LS means were calculated by subtracting the LS mean of placebo group from the LS mean of ASP8062 30 mg group using a MMRM model with change from baseline to weeks 2, 4 and 8 as response, treatment, center (pooled where necessary), time (study weeks 2, 4 and 8) and treatment-by-time interaction as fixed effects, baseline and baseline-by-time interaction as covariates.||5.30|-3.57|0.626
72496715|NCT01162421|144522801|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|0.24||0.204|TWO_SIDED|95.0|-0.2|0.8||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 9||0.8|-0.2|0.204
72559858|NCT00494013|144650139|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority margin of 0.8 millimoles per Liter (mmol/L).|Mean Difference (Net)|0.1||||0.107||95.0|-0.02|0.23|||ANOVA|ANOVA model: Variable=Treatment + Country + Baseline HbA1c + Baseline Sulfonylurea Group.|The two-sided 95% confidence interval is for the Least Squares Mean difference between the two treatments (Insulin Lispro Protamine Suspension minus Determir).|The first gatekeeping hypothesis was that Insulin Lispro Protamine Suspension was noninferior to determir.||0.23|-0.02|0.107
72559859|NCT00494013|144650140|SUPERIORITY_OR_OTHER|||||||0.952||95.0||||P-value for Average 7-Point SMBG.|ANOVA|ANOVA Model: Variable = Treatment + Country + Baseline HbA1c + Baseline Sulfonylurea Group.||||||0.952
72496716|NCT01162421|144522801|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|0.22||0.227|TWO_SIDED|95.0|-0.2|0.7||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 12||0.7|-0.2|0.227
72496717|NCT01162421|144522801|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.23||0.86|TWO_SIDED|95.0|-0.4|0.5||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 18||0.5|-0.4|0.860
72496718|NCT01162421|144522801|SUPERIORITY_OR_OTHER||LS Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|0.22||0.476|TWO_SIDED|95.0|-0.3|0.6||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 24||0.6|-0.3|0.476
72496719|NCT00565617|144522835|SUPERIORITY_OR_OTHER_LEGACY|||||||0.009|TWO_SIDED||||||ANOVA|||||||0.009
72559860|NCT00494013|144650140|SUPERIORITY_OR_OTHER|||||||0.856||95.0||||P-value for Average Pre-Meal.|ANOVA|ANOVA Model: Variable = Treatment + Country + Baseline HbA1c + Baseline Sulfonylurea Group.||||||0.856
72559861|NCT00494013|144650140|SUPERIORITY_OR_OTHER|||||||0.79||95.0||||P-value for Average Post-Meal.|ANOVA|ANOVA Model: Variable = Treatment + Country + Baseline HbA1c + Baseline Sulfonylurea Group.||||||0.790
72559862|NCT00494013|144650140|SUPERIORITY_OR_OTHER|||||||0.632||95.0||||P-value for Average Morning+Evening Pre-Meal.|ANOVA|ANOVA Model: Variable = Treatment + Country + Baseline HbA1c + Baseline Sulfonylurea Group.||||||0.632
72619149|NCT01550965|144769021|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-26.54|||<|0.001|TWO_SIDED|95.0|-31.08|-22.0|||Paired t-test, 2 sided|||Statistical analysis for mean change in WPAI-SHP: overall work impairment percentage from week 0 to week 8.||-22.00|-31.08|<0.001
72443154|NCT03092726|144399457|SUPERIORITY||LSM Difference|1.09|STANDARD_ERROR_OF_MEAN|2.57||0.664|TWO_SIDED|90.0|-3.16|5.34||1-sided p-value is for comparison of ASP8062 30 mg with placebo from the above described ANCOVA model.|ANCOVA|||EOT: Differences of LS means were calculated by subtracting the LS mean of placebo group from the LS mean of ASP8062 30 mg group using an ANCOVA model that was performed with change from baseline at the EOT timepoint as response, treatment and center (pooled where necessary) as fixed effects and baseline as a covariate.||5.34|-3.16|0.664
72443155|NCT03092726|144399458|SUPERIORITY||LSM Difference|0.16|STANDARD_ERROR_OF_MEAN|1.85||0.534|TWO_SIDED|90.0|-2.9|3.22||1-sided p-value is for comparison of ASP8062 30 mg with placebo from the above described MMRM model.|MMRM|||Week 2: Differences of LS means were calculated by subtracting the LS mean of placebo group from the LS mean of ASP8062 30 mg group using a MMRM model with change from baseline to weeks 2, 4 and 8 as response, treatment, center (pooled where necessary), time (study weeks 2, 4 and 8) and treatment-by-time interaction as fixed effects, baseline and baseline-by-time interaction as covariates.||3.22|-2.90|0.534
72496720|NCT01890421|144522840|SUPERIORITY||Sensitivity Difference|-0.7||||0.8694|ONE_SIDED|95.0|-8.5||||McNemar 1-sided test,alpha level of 2.5%|||Statistical analysis 1 for presence of a myocardial perfusion defect indicating significant cad per participant on gadobutrol-enhanced CMRI versus unenhanced wall motion CMRI images - primary analysis of sensitivity comparison based on the blinded readers' assessment. Sensitivity of gadobutrol-enhanced CMRI was compared with sensitivity of unenhanced CMRI evaluated by Reader 1.|||-8.5|0.8694
72496721|NCT01890421|144522840|SUPERIORITY||Sensitivity Difference|29.1|||<|0.0001|ONE_SIDED|95.0|21.7||||McNemar 1-sided test,alpha level of 2.5%|||Statistical analysis 2 for presence of a myocardial perfusion defect indicating significant cad per participant on gadobutrol-enhanced CMRI versus unenhanced wall motion CMRI images - primary analysis of sensitivity comparison based on the blinded readers' assessment. Sensitivity of gadobutrol-enhanced CMRI was compared with sensitivity of unenhanced CMRI evaluated by Reader 2.|||21.7|<0.0001
72496722|NCT01890421|144522840|SUPERIORITY||Sensitivity Difference|24.1|||<|0.0001|ONE_SIDED|95.0|16.6||||McNemar 1-sided test,alpha level of 2.5%|||Statistical analysis 3 for presence of a myocardial perfusion defect indicating significant cad per participant on gadobutrol-enhanced CMRI versus unenhanced wall motion CMRI images - primary analysis of sensitivity comparison based on the blinded readers' assessment. Sensitivity of gadobutrol-enhanced CMRI was compared with sensitivity of unenhanced CMRI evaluated by Reader 3.|||16.6|<0.0001
72496723|NCT01890421|144522841|SUPERIORITY||Sensitivity Difference]|7.4||||0.0455|ONE_SIDED|95.0|0.5||||McNemar 1-sided test,alpha level of 2.5%|||Statistical analysis 1 for presence of a myocardial perfusion defect indicating significant CAD per participant on gadobutrol-enhanced CMRI versus unenhanced wall motion CMRI images - additional secondary analysis of sensitivity comparison based on the blinded readers' assessment. Sensitivity of gadobutrol-enhanced CMRI was compared with sensitivity of unenhanced CMRI evaluated by Reader 1.|||0.5|0.0455
72496724|NCT01890421|144522841|SUPERIORITY||Sensitivity Difference]|34.3|||<|0.0001|ONE_SIDED|95.0|25.2||||McNemar 1-sided test,alpha level of 2.5%|||Statistical analysis 2 for presence of a myocardial perfusion defect indicating significant CAD per participant on gadobutrol-enhanced CMRI versus unenhanced wall motion CMRI images - additional secondary analysis of sensitivity comparison based on the blinded readers' assessment. Sensitivity of gadobutrol-enhanced CMRI was compared with sensitivity of unenhanced CMRI evaluated by Reader 2.|||25.2|<0.0001
72496725|NCT01890421|144522841|SUPERIORITY||Sensitivity Difference|30.6|||<|0.0001|ONE_SIDED|95.0|21.7||||McNemar 1-sided test,alpha level of 2.5%|||Statistical analysis 3 for presence of a myocardial perfusion defect indicating significant CAD per participant on gadobutrol-enhanced CMRI versus unenhanced wall motion CMRI images - additional secondary analysis of sensitivity comparison based on the blinded readers' assessment. Sensitivity of gadobutrol-enhanced CMRI was compared with sensitivity of unenhanced CMRI evaluated by Reader 3.|||21.7|<0.0001
72496726|NCT01890421|144522846|SUPERIORITY||Sensitivity Difference|27.9|||<|0.0001|TWO_SIDED|95.0|18.5|35.8|||McNemar 2-sided test,alpha level of 5%|||Statistical analysis 1 for presence of a myocardial perfusion defect indicating significant CAD per participant on gadobutrol-enhanced CMRI versus unenhanced wall motion CMRI images - secondary analysis of sensitivity comparison based on investigator's assessment. Sensitivity of gadobutrol-enhanced CMRI was compared with sensitivity of unenhanced CMRI. Maximum stenosis severity at least \>=50% by QCA.||35.8|18.5|<0.0001
72496727|NCT01890421|144522846|SUPERIORITY||Sensitivity Difference|27.9|||<|0.0001|TWO_SIDED|95.0|19.9|34.4|||McNemar 2-sided test,alpha level of 10%|||Statistical analysis 2 for presence of a myocardial perfusion defect indicating significant CAD per participant on gadobutrol-enhanced CMRI versus unenhanced wall motion CMRI images - secondary analysis of sensitivity comparison based on investigator's assessment. Sensitivity of gadobutrol-enhanced CMRI was compared with sensitivity of unenhanced CMRI. Maximum stenosis severity at least \>=50% by QCA.||34.4|19.9|<0.0001
72496728|NCT01446419|144522876|SUPERIORITY_OR_OTHER|||||||0.019|||||||ANCOVA|P-value from ANCOVA with factors of tx group, analysis center and tx group by analysis center interaction, and a covariate of baseline ODI score.||||||0.019
72496729|NCT01228903|144522879|EQUIVALENCE|(Doehner et al.) CHF patients on allopurinol (n= 14) had improved BA-FMD= 10.6 ± 2.0 (mean ± SE) vs placebo (n= 14, FMD= 6.7 ± 0.1); difference in means= 3.9. Yiginer et al. found a similar difference in metabolic syndrome. A sample size of 34/group will have 80% power to detect a difference in means of 3.9 (common standard deviation=5.6, two group t-test=0.050 two-sided significance). Accounting for a potential drop-out rate17%, n= 40/group was recruited.|Mean Difference (Net)|0.7||||0.47|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||The estimated value represents the difference between the change from baseline in both groups.|The null hypothesis was the there will be no difference between the placebo and allopurinol. The power for the study was calculated (as appropriate) based on the prior literature.||||0.47
72496730|NCT02867761|144522885|SUPERIORITY||Odds Ratio (OR)|0.91||||0.65|TWO_SIDED|95.0|0.6|1.37|||Generalized Estimating Equation|||||1.37|0.60|0.65
72559863|NCT00494013|144650141|SUPERIORITY_OR_OTHER|||||||0.472||95.0||||P-value for All Hypoglycemic Events.|Fisher Exact|||||||0.472
72559864|NCT00494013|144650141|SUPERIORITY_OR_OTHER|||||||0.005||95.0||||P-value for Nocturnal Hypoglycemic Events.|Fisher Exact|||||||0.005
72559865|NCT00494013|144650141|SUPERIORITY_OR_OTHER|||||||0.45||95.0||||P-value for Severe Hypoglycemic Events.|Fisher Exact|||||||0.450
72559866|NCT00494013|144650142|SUPERIORITY_OR_OTHER|||||||0.001||95.0||||P-value for Hypoglycemic Rate.|ANOVA|Nonparametric ANOVA Model: Rank of Variable = Treatment + Country + Baseline HbA1c + Baseline Sulfonylurea Group.||||||0.001
72388512|NCT01594281|144285253|OTHER|The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.|Least Squares Mean Difference|3.0||||0.2767|TWO_SIDED|95.0|-2.5|8.5|||ANCOVA|||||8.5|-2.5|0.2767
72443156|NCT03092726|144399458|SUPERIORITY||LSM Difference|1.46|STANDARD_ERROR_OF_MEAN|2.08||0.758|TWO_SIDED|90.0|-1.98|4.91||1-sided p-value is for comparison of ASP8062 30 mg with placebo from the above described MMRM model.|MMRM|||Week 4: Differences of LS means were calculated by subtracting the LS mean of placebo group from the LS mean of ASP8062 30 mg group using a MMRM model with change from baseline to weeks 2, 4 and 8 as response, treatment, center (pooled where necessary), time (study weeks 2, 4 and 8) and treatment-by-time interaction as fixed effects, baseline and baseline-by-time interaction as covariates.||4.91|-1.98|0.758
72443157|NCT03092726|144399458|SUPERIORITY||LSM Difference|1.7|STANDARD_ERROR_OF_MEAN|2.57||0.745|TWO_SIDED|90.0|-2.56|5.96||1-sided p-value is for comparison of ASP8062 30 mg with placebo from the above described MMRM model.|MMRM|||Week 8: Differences of LS means were calculated by subtracting the LS mean of placebo group from the LS mean of ASP8062 30 mg group using a MMRM model with change from baseline to weeks 2, 4 and 8 as response, treatment, center (pooled where necessary), time (study weeks 2, 4 and 8) and treatment-by-time interaction as fixed effects, baseline and baseline-by-time interaction as covariates.||5.96|-2.56|0.745
72443158|NCT03092726|144399458|SUPERIORITY||LSM Difference|1.68|STANDARD_ERROR_OF_MEAN|2.43||0.755|TWO_SIDED|90.0|-2.34|5.69||1-sided p-value is for comparison of ASP8062 30 mg with placebo from the above described ANCOVA model.|ANCOVA|||EOT: Differences of LS means were calculated by subtracting the LS mean of placebo group from the LS mean of ASP8062 30 mg group using an ANCOVA model that was performed with change from baseline at the EOT timepoint as response, treatment and center (pooled where necessary) as fixed effects and baseline as a covariate.||5.69|-2.34|0.755
72443159|NCT03092726|144399459|SUPERIORITY||LSM Difference|0.19|STANDARD_ERROR_OF_MEAN|0.59||0.629|TWO_SIDED|90.0|-0.78|1.17||1-sided p-value is for comparison of ASP8062 30 mg with placebo from the above described MMRM model.|MMRM|||Week 2: Differences of LS means were calculated by subtracting the LS mean of placebo group from the LS mean of ASP8062 30 mg group using a MMRM model with change from baseline to weeks 2, 4 and 8 as response, treatment, center (pooled where necessary), time (study weeks 2, 4 and 8) and treatment-by-time interaction as fixed effects, baseline and baseline-by-time interaction as covariates.||1.17|-0.78|0.629
72443160|NCT03092726|144399459|SUPERIORITY||LSM Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.73||0.41|TWO_SIDED|90.0|-1.37|1.04||1-sided p-value is for comparison of ASP8062 30 mg with placebo from the above described MMRM model.|MMRM|||Week 4: Differences of LS means were calculated by subtracting the LS mean of placebo group from the LS mean of ASP8062 30 mg group using a MMRM model with change from baseline to weeks 2, 4 and 8 as response, treatment, center (pooled where necessary), time (study weeks 2, 4 and 8) and treatment-by-time interaction as fixed effects, baseline and baseline-by-time interaction as covariates.||1.04|-1.37|0.410
72559867|NCT00494013|144650142|SUPERIORITY_OR_OTHER|||||||0.001||95.0||||P-value for Nocturnal Hypoglycemic Rate.|ANOVA|Nonparametric ANOVA Model: Rank of Variable = Treatment + Country + Baseline HbA1c + Baseline Sulfonylurea Group.||||||0.001
72388513|NCT01594281|144285253|OTHER|The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.|Least Squares Mean Difference|-2.5||||0.3641|TWO_SIDED|95.0|-7.9|2.9|||ANCOVA|||||2.9|-7.9|0.3641
72388514|NCT01594281|144285254|OTHER|The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.|Odds Ratio (OR)|0.47||||0.4019|TWO_SIDED|95.0|0.08|2.749|||Regression, Logistic|||≥10 letters gain||2.749|0.080|0.4019
72388515|NCT01594281|144285254|OTHER|The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.|Odds Ratio (OR)|1.833||||0.2772|TWO_SIDED|95.0|0.614|5.471|||Regression, Logistic|||≥5 letters gain||5.471|0.614|0.2772
72388516|NCT01594281|144285254|OTHER|The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.|Odds Ratio (OR)|1.412||||0.4731|TWO_SIDED|95.0|0.55|3.622|||Regression, Logistic|||No clinically relevant change||3.622|0.55|0.4731
72388517|NCT01594281|144285254|OTHER|The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.|Odds Ratio (OR)|0.35||||0.065|TWO_SIDED|95.0|0.155|1.068|||Regression, Logistic|||≥5 letters loss||1.068|0.155|0.065
72559868|NCT00494013|144650142|SUPERIORITY_OR_OTHER|||||||0.226||95.0||||P-value for Severe Hypoglycemic Rate.|ANOVA|Nonparametric ANOVA Model: Rank of Variable = Treatment + Country + Baseline HbA1c + Baseline Sulfonylurea Group.||||||0.226
72388518|NCT01594281|144285254|OTHER|The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.|Odds Ratio (OR)|1.0||||1|TWO_SIDED|95.0|0.229|4.361|||Regression, Logistic|||≥10 letters loss||4.361|0.229|1.000
72388519|NCT01594281|144285254|OTHER|The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.|Odds Ratio (OR)|0.314||||0.3261|TWO_SIDED|95.0|0.031|3.173|||Regression, Logistic|||≥15 letters loss||3.173|0.031|0.3261
72388520|NCT01594281|144285254|OTHER|The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.|Odds Ratio (OR)|0.667||||0.668|TWO_SIDED|95.0|0.104|4.253|||Regression, Logistic|||≥10 letters gain||4.253|0.104|0.6680
72388521|NCT01594281|144285254|OTHER|The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.|Odds Ratio (OR)|2.842||||0.0838|TWO_SIDED|95.0|0.87|9.283|||Regression, Logistic|||≥5 letters gain||9.283|0.870|0.0838
72388522|NCT01594281|144285254|OTHER|The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.|Odds Ratio (OR)|0.674||||0.4116|TWO_SIDED|95.0|0.263|1.729|||Regression, Logistic|||No clinically relevant change||1.729|0.263|0.4116
72388523|NCT01594281|144285254|OTHER|The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.|Odds Ratio (OR)|0.621||||0.4197|TWO_SIDED|95.0|0.195|1.977|||Regression, Logistic|||≥5 letters loss||1.977|0.195|0.4197
72388524|NCT01594281|144285254|OTHER|The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.|Odds Ratio (OR)|1.419||||0.6632|TWO_SIDED|95.0|0.294|6.856|||Regression, Logistic|||≥10 letters loss||6.856|0.294|0.6632
72388525|NCT01594281|144285254|OTHER|The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.|Odds Ratio (OR)|1.029||||0.9839|TWO_SIDED|95.0|0.062|17.127|||Regression, Logistic|||≥15 letters loss||17.127|0.062|0.9839
72388526|NCT01594281|144285254|OTHER|The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.|Odds Ratio (OR)|1.419||||0.663|TWO_SIDED|95.0|0.294|6.858|||Regression, Logistic|||≥10 letters gain||6.858|0.294|0.6630
72388527|NCT01594281|144285254|OTHER|The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.|Odds Ratio (OR)|1.55||||0.4941|TWO_SIDED|95.0|0.441|5.444||P-value was calculated as a point estimate.|Regression, Logistic|||≥5 letters gain||5.444|0.441|0.4941
72388528|NCT01594281|144285254|OTHER|The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.|Odds Ratio (OR)|0.477||||0.1259|TWO_SIDED|95.0|0.185|1.231|||Regression, Logistic|||No clinically relevant change||1.231|0.185|0.1259
72388529|NCT01594281|144285254|OTHER|The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.|Odds Ratio (OR)|1.773||||0.271|TWO_SIDED|95.0|0.64|4.913|||Regression, Logistic|||≥5 letters loss||4.913|0.640|0.2710
72388530|NCT01594281|144285254|OTHER|The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.|Odds Ratio (OR)|1.419||||0.6632|TWO_SIDED|95.0|0.294|6.856|||Regression, Logistic|||≥10 letters loss||6.856|0.294|0.6632
72388531|NCT01594281|144285254|OTHER|The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.|Odds Ratio (OR)|3.282||||0.314|TWO_SIDED|95.0|0.325|33.171|||Regression, Logistic|||≥15 letters loss||33.171|0.325|0.3140
72388532|NCT01594281|144285255|OTHER|The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.|Odds Ratio (OR)|0.994||||0.9918|TWO_SIDED|95.0|0.327|3.026|||Regression, Logistic|||≥ 1 class improvement from Baseline at EOCS||3.026|0.327|0.9918
72388533|NCT01594281|144285255|OTHER|The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.|Odds Ratio (OR)|0.607||||0.3595|TWO_SIDED|95.0|0.209|1.765|||Regression, Logistic|||≥ 1 class improvement from Baseline at EOCS||1.765|0.209|0.3595
72388534|NCT01594281|144285255|OTHER|The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.|Odds Ratio (OR)|0.611||||0.3787|TWO_SIDED|95.0|0.204|1.83|||Regression, Logistic|||≥ 1 class improvement from Baseline at EOCS||1.830|0.204|0.3787
72388535|NCT01594281|144285255|OTHER|The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.|Odds Ratio (OR)|0.889||||0.9097|TWO_SIDED|95.0|0.116|6.806|||Regression, Logistic|||≥ 2 class improvement from Baseline at EOCS||6.806|0.116|0.9097
72388536|NCT01594281|144285255|OTHER|The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.|Odds Ratio (OR)|0.341||||0.223|TWO_SIDED|95.0|0.06|1.925|||Regression, Logistic|||≥ 2 class improvement from Baseline at EOCS||1.925|0.060|0.2230
72388537|NCT01594281|144285255|OTHER|The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.|Odds Ratio (OR)|0.383||||0.2792|TWO_SIDED|95.0|0.068|2.177|||Regression, Logistic|||≥ 2 class improvement from Baseline at EOCS||2.177|0.068|0.2792
72388538|NCT01594281|144285256|OTHER|The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.|Least Squares Mean Difference|-40.7||||0.0003|TWO_SIDED|95.0|-62.1|-19.3|||ANCOVA|||||-19.3|-62.1|0.0003
72443161|NCT03092726|144399459|SUPERIORITY||LSM Difference|0.06|STANDARD_ERROR_OF_MEAN|0.71||0.531|TWO_SIDED|90.0|-1.11|1.22||1-sided p-value is for comparison of ASP8062 30 mg with placebo from the above described MMRM model.|MMRM|||Week 8: Differences of LS means were calculated by subtracting the LS mean of placebo group from the LS mean of ASP8062 30 mg group using a MMRM model with change from baseline to weeks 2, 4 and 8 as response, treatment, center (pooled where necessary), time (study weeks 2, 4 and 8) and treatment-by-time interaction as fixed effects, baseline and baseline-by-time interaction as covariates.||1.22|-1.11|0.531
72443162|NCT03092726|144399459|SUPERIORITY||LSM Difference|0.17|STANDARD_ERROR_OF_MEAN|0.67||0.603|TWO_SIDED|90.0|-0.93|1.28||1-sided p-value is for comparison of ASP8062 30 mg with placebo from the above described ANCOVA model.|ANCOVA|||EOT: Differences of LS means were calculated by subtracting the LS mean of placebo group from the LS mean of ASP8062 30 mg group using an ANCOVA model that was performed with change from baseline at the EOT timepoint as response, treatment and center (pooled where necessary) as fixed effects and baseline as a covariate.||1.28|-0.93|0.603
72443163|NCT03092726|144399460|SUPERIORITY||Odds Ratio (OR)|1.07||||0.811|TWO_SIDED|90.0|0.68|1.67||2-sided p-value is for the comparison of ASP8062 30 mg with placebo from the above described proportional odds model.|Proportional Odds model|||Week 2: Odds ratio of ASP8062 30 mg versus placebo, associated 90% 2-sided CI and p-value was estimated using a proportional odds model including treatment group as a factor.||1.67|0.68|0.811
72496731|NCT02867761|144522889|SUPERIORITY|||||||0.3|||||||Linear Mixed Effects Model|||||||0.30
72496732|NCT02867761|144522890|SUPERIORITY|||||||0.49|||||||Linear Mixed Effects Model|||||||0.49
72443164|NCT03092726|144399460|SUPERIORITY||Odds Ratio (OR)|0.79||||0.368|TWO_SIDED|90.0|0.5|1.22||2-sided p-value is for the comparison of ASP8062 30 mg with placebo from the above described proportional odds model.|Proportional Odds model|||Week 4: Odds ratio of ASP8062 30 mg versus placebo, associated 90% 2-sided CI and p-value was estimated using a proportional odds model including treatment group as a factor.||1.22|0.50|0.368
72443165|NCT03092726|144399460|SUPERIORITY||Odds Ratio (OR)|0.78||||0.357|TWO_SIDED|90.0|0.5|1.21||2-sided p-value is for the comparison of ASP8062 30 mg with placebo from the above described proportional odds model.|Proportional Odds model|||Week 8: Odds ratio of ASP8062 30 mg versus placebo, associated 90% 2-sided CI and p-value was estimated using a proportional odds model including treatment group as a factor.||1.21|0.50|0.357
72443166|NCT03092726|144399460|SUPERIORITY||Odds Ratio (OR)|0.8||||0.407|TWO_SIDED|90.0|0.52|1.24||2-sided p-value is for the comparison of ASP8062 30 mg with placebo from the above described proportional odds model.|Proportional Odds model|||EOT: Odds ratio of ASP8062 30 mg versus placebo, associated 90% 2-sided CI and p-value was estimated using a proportional odds model including treatment group as a factor.||1.24|0.52|0.407
72443167|NCT04950127|144399461|SUPERIORITY||Mean Difference (Net)|-0.72||||0.001|TWO_SIDED|95.0|-1.15|-0.28|||Mixed Models Analysis|Mixed Model Repeated Measures Analysis||The mixed model repeated measures analysis includes Treatment Group, Visit, Visit\*Treatment Group interaction, Baseline Monthly Itch score (MIS), Visit\*Baseline MIS interaction, Baseline Concomitant Itch Medication.||-0.28|-1.15|0.001
72443168|NCT04950127|144399462|SUPERIORITY||Mean Difference (Net)|-0.71|||<|0.001|TWO_SIDED|95.0|-1.07|-0.34||Adjusted for multiplicity as per Statistical Analysis Plan (SAP)|Mixed Models Analysis|Mixed Model Repeated Measures Analysis||The mixed model repeated measures analysis includes Treatment Group, Week, Week\*Treatment Group interaction, Baseline Weekly Itch score (WIS), Visit\*Baseline WIS interaction, Baseline Concomitant Itch Medication.||-0.34|-1.07|<0.001
72443169|NCT04950127|144399463|SUPERIORITY||Mean Difference (Net)|-0.53||||0.024|TWO_SIDED|95.0|-0.98|-0.07||Adjusted for multiplicity as per Statistical Analysis Plan (SAP)|Mixed Models Analysis|Mixed Model Repeated Measures Analysis||The mixed model repeated measures analysis includes Treatment Group, Visit, Visit\*Treatment Group interaction, Baseline Monthly sleep score (MSS), Visit\*Baseline MSS interaction, Baseline Concomitant Itch Medication.||-0.07|-0.98|0.024
72443170|NCT04950127|144399464|SUPERIORITY||Percentage difference|4.0||||0.539||95.0|-9.0|17.0||Adjusted for multiplicity as per Statistical Analysis Plan (SAP)|Cochran-Mantel-Haenszel|||Cochran-Mantel-Haenszel (CMH) stratified analysis adjusted for baseline factors: Baseline Itch Severity (Moderate: \>=4 and less than \[\<\]7, Severe: \>=7); Concomitant cholestatic pruritus treatment regimen (Regimen contains Bile Acid Binding Resin \[BABR\], Regimen does not contain BABR, No defined treatment). Multiple imputation of missing Monthly itch scores was done before deriving responder definitions. Imputed datasets were analyzed using the CMH method and combined.||17.0|-9.0|0.539
72443171|NCT04950127|144399465|SUPERIORITY||Percentage Difference|13.0||||0.043|TWO_SIDED|95.0|0.0|27.0||Adjusted for multiplicity; two-sided p-values \<0.05 were considered to be nominally significant as per SAP.|Cochran-Mantel-Haenszel|||Cochran-Mantel-Haenszel (CMH) stratified analysis adjusted for baseline factors: Baseline Itch Severity (Moderate: \>=4 and \<7, Severe: \>=7); Concomitant cholestatic pruritus treatment regimen (Regimen contains BABR, Regimen does not contain BABR, No defined treatment). Multiple imputation of missing Monthly itch scores was done before deriving responder definitions. Imputed datasets were analyzed using the CMH method and combined.||27.0|0.0|0.043
72443172|NCT04950127|144399466|SUPERIORITY||Percentage Difference|12.0||||0.058|TWO_SIDED|95.0|0.0|24.0||Adjusted for multiplicity; two-sided p-values \<0.05 were considered to be nominally significant as per SAP.|Cochran-Mantel-Haenszel|||Cochran-Mantel-Haenszel (CMH) stratified analysis adjusted for baseline factors: Baseline Itch Severity (Moderate: \>=4 and \<7, Severe: \>=7); Concomitant cholestatic pruritus treatment regimen (Regimen contains BABR, Regimen does not contain BABR, No defined treatment). Multiple imputation of missing Monthly itch scores was done before deriving responder definitions. Imputed datasets were analyzed using the CMH method and combined.||24.0|-0.0|0.058
72443173|NCT04950127|144399467|SUPERIORITY|Cognitive|Mean Difference (Net)|0.76||||0.176|TWO_SIDED|95.0|-0.34|1.86||Not adjusted for multiplicity; two-sided p- values \<0.05 were considered to be nominally significant as per SAP.|Mixed Models Analysis|Mixed Model Repeated Measures Analysis||The mixed model repeated measures analysis includes Treatment Group, Visit, Visit\*Treatment Group interaction, Baseline PBC-40 domain scores, Visit\*Baseline PBC-40 domain scores interaction, Baseline Concomitant Itch Medication.||1.86|-0.34|0.176
72443174|NCT04950127|144399467|SUPERIORITY|Emotional|Mean Difference (Net)|0.27||||0.403|TWO_SIDED|95.0|-0.36|0.89||Not adjusted for multiplicity; two-sided p- values \<0.05 were considered to be nominally significant as per SAP.|Mixed Models Analysis|Mixed Model Repeated Measures Analysis||The mixed model repeated measures analysis includes Treatment Group, Visit, Visit\*Treatment Group interaction, Baseline PBC-40 domain scores, Visit\*Baseline PBC-40 domain scores interaction, Baseline Concomitant Itch Medication.||0.89|-0.36|0.403
72443175|NCT04950127|144399467|SUPERIORITY|Fatigue|Mean Difference (Net)|1.59||||0.132|TWO_SIDED|95.0|-0.48|3.67||Not adjusted for multiplicity; two-sided p- values \<0.05 were considered to be nominally significant as per SAP.|Mixed Models Analysis|Mixed Model Repeated Measures Analysis||The mixed model repeated measures analysis includes Treatment Group, Visit, Visit\*Treatment Group interaction, Baseline PBC-40 domain scores, Visit\*Baseline PBC-40 domain scores interaction, Baseline Concomitant Itch Medication.||3.67|-0.48|0.132
72496733|NCT02867761|144522891|SUPERIORITY|||||||0.96|||||||Linear Mixed Effects Model|||||||0.96
72496734|NCT02867761|144522892|SUPERIORITY||||||<|0.001|||||||Linear Mixed Effects Model|||||||<0.001
72496735|NCT02867761|144522895|SUPERIORITY|||||||0.35|||||||Linear Mixed Effects Model|||P Value for percentage of days with any symptoms (shortness of breath, chest tightness, wheezing, cough, or sputum)||||0.35
72496736|NCT02867761|144522895|SUPERIORITY|||||||0.61|||||||Linear Mixed Effects Model|||P Value for percentage of days with shortness of breath||||0.61
72496737|NCT02867761|144522895|SUPERIORITY|||||||0.48|||||||Linear Mixed Effects Model|||P Value for percentage of days with chest tightness||||0.48
72496738|NCT02867761|144522895|SUPERIORITY|||||||0.81|||||||Linear Mixed Effects Model|||P Value for percentage of days with wheezing||||0.81
72496739|NCT02867761|144522895|SUPERIORITY|||||||0.17|||||||Linear Mixed Effects Model|||P Value for percentage of days with cough||||0.17
72443176|NCT04950127|144399467|SUPERIORITY|Itch|Mean Difference (Net)|-0.58||||0.132|TWO_SIDED|95.0|-1.34|0.18||Not adjusted for multiplicity; two-sided p- values \<0.05 were considered to be nominally significant as per SAP.|Mixed Models Analysis|Mixed Model Repeated Measures Analysis||The mixed model repeated measures analysis includes Treatment Group, Visit, Visit\*Treatment Group interaction, Baseline PBC-40 domain scores, Visit\*Baseline PBC-40 domain scores interaction, Baseline Concomitant Itch Medication.||0.18|-1.34|0.132
72388539|NCT01594281|144285256|OTHER|The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.|Least Squares Mean Difference|-22.9||||0.0357|TWO_SIDED|95.0|-44.2|-1.6|||ANCOVA|||||-1.6|-44.2|0.0357
72388540|NCT01594281|144285256|OTHER|The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.|Least Squares Mean Difference|17.8||||0.1034|TWO_SIDED|95.0|-3.7|39.3|||ANCOVA|||||39.3|-3.7|0.1034
72388541|NCT01594281|144285257|OTHER|The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.|Least Squares Mean Difference|-51.7||||0.0007|TWO_SIDED|95.0|-81.1|-22.3|||ANCOVA|||||-22.3|-81.1|0.0007
72388542|NCT01594281|144285257|OTHER|The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.|Least Squares Mean Difference|-28.9||||0.0542|TWO_SIDED|95.0|-58.4|0.5|||ANCOVA|||||0.5|-58.4|0.0542
72388543|NCT01594281|144285257|OTHER|The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.|Least Squares Mean Difference|22.8||||0.1288|TWO_SIDED|95.0|-6.7|52.3|||ANCOVA|||||52.3|-6.7|0.1288
72388544|NCT02195583|144285290|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANOVA|Calculated from Analysis of Variance (ANOVA) model using treatment and study period as fixed factors and participant as random effect.||Linear contrasts were fitted in order to establish whether there was a dose-response relationship. Linear contrasts were for experimental dentifrice: non-zinc treatments.||||<0.0001
72388545|NCT02195583|144285290|SUPERIORITY_OR_OTHER|||||||0.2274||95.0|||||ANOVA|Calculated from ANOVA model using treatment and study period as fixed factors and participant as random effect.||Quadratic contrasts were fitted in order to establish whether there was a dose-response relationship. Quadratic contrasts are for experimental dentifrice: non-zinc treatments.||||0.2274
72388546|NCT02195583|144285290|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.68||||0.595|TWO_SIDED|95.0|-1.84|3.2|||ANOVA|Calculated from ANOVA model using treatment and study period as fixed factors and participant as random effect.|Difference was calculated as Sodium fluoride (1426 ppm) minus Sodium fluoride (1150 ppm) such that a positive difference favors Sodium fluoride (1426 ppm).|||3.20|-1.84|0.5950
72388547|NCT02195583|144285290|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.93||||0.0002|TWO_SIDED|95.0|2.38|7.48|||ANOVA|Calculated from ANOVA model using treatment and study period as fixed factors and participant as random effect.|Difference was calculated as Sodium fluoride (1426 ppm) minus Sodium fluoride (250 ppm) such that a positive difference favors Sodium fluoride (1426 ppm).|||7.48|2.38|0.0002
72388548|NCT02195583|144285290|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.25||||0.0013|TWO_SIDED|95.0|1.68|6.82|||ANOVA|Calculated from ANOVA model using treatment and study period as fixed factors and participant as random effect.|Difference was calculated as Sodium fluoride (1150 ppm) minus Sodium fluoride (250 ppm) such that a positive difference favors Sodium fluoride (1150 ppm).|||6.82|1.68|0.0013
72388549|NCT02195583|144285290|SUPERIORITY_OR_OTHER||Mean Difference (Net)|7.71|||<|0.0001|TWO_SIDED|95.0|5.2|10.21|||ANOVA|Calculated from ANOVA model using treatment and study period as fixed factors and participant as random effect.|Difference was calculated as Sodium fluoride (1426 ppm) minus Sodium fluoride (0 ppm) such that a positive difference favors Sodium fluoride (1426 ppm).|||10.21|5.20|<0.0001
72443177|NCT04950127|144399467|SUPERIORITY|Social|Mean Difference (Net)|-0.15||||0.836|TWO_SIDED|95.0|-1.57|1.27||Not adjusted for multiplicity; two-sided p- values \<0.05 were considered to be nominally significant as per SAP.|Mixed Models Analysis|Mixed Model Repeated Measures Analysis||The mixed model repeated measures analysis includes Treatment Group, Visit, Visit\*Treatment Group interaction, Baseline PBC-40 domain scores, Visit\*Baseline PBC-40 domain scores interaction, Baseline Concomitant Itch Medication.||1.27|-1.57|0.836
72496740|NCT02867761|144522895|SUPERIORITY|||||||0.64|||||||Linear Mixed Effects Model|||P Value for percentage of days with sputum||||0.64
72388550|NCT02195583|144285290|SUPERIORITY_OR_OTHER||Mean Difference (Net)|7.03|||<|0.0001|TWO_SIDED|95.0|4.51|9.55|||ANOVA|Calculated from ANOVA model using treatment and study period as fixed factors and participant as random effect.|Difference was calculated as Sodium fluoride (1150 ppm) minus Sodium fluoride (0 ppm) such that a positive difference favors Sodium fluoride (1150 ppm).|||9.55|4.51|<0.0001
72388551|NCT02195583|144285290|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.78||||0.0325|TWO_SIDED|95.0|0.23|5.32|||ANOVA|Calculated from ANOVA model using treatment and study period as fixed factors and participant as random effect.|Difference was calculated as Sodium fluoride (250 ppm) minus Sodium fluoride (0 ppm) such that a positive difference favors Sodium fluoride (250 ppm).|||5.32|0.23|0.0325
72388552|NCT02195583|144285290|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.16||||0.092|TWO_SIDED|95.0|-4.67|0.35|||ANOVA|Calculated from ANOVA model using treatment and study period as fixed factors and participant as random effect.|Difference was calculated as 'Sodium fluoride (1426 ppm) + zinc base A' minus Sodium fluoride (0 ppm) such that a positive difference favors 'Sodium fluoride (1426 ppm) + zinc base A'.|||0.35|-4.67|0.0920
72388553|NCT02195583|144285290|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.56||||0.2185|TWO_SIDED|95.0|-4.04|0.93|||ANOVA|Calculated from ANOVA model using treatment and study period as fixed factors and participant as random effect.|Difference was calculated as 'Sodium fluoride (1426 ppm) + zinc base B' minus Sodium fluoride (0 ppm) such that a positive difference favors 'Sodium fluoride (1426 ppm) + zinc base B'.|||0.93|-4.04|0.2185
72388554|NCT02195583|144285290|SUPERIORITY_OR_OTHER||Mean Difference (Net)|9.87|||<|0.0001|TWO_SIDED|95.0|7.36|12.37|||ANOVA|Calculated from ANOVA model using treatment and study period as fixed factors and participant as random effect.|Difference was calculated as Sodium fluoride (1426 ppm) minus 'Sodium fluoride (1426 ppm) + zinc base A' such that a positive difference favors Sodium fluoride (1426 ppm).|||12.37|7.36|<0.0001
72559869|NCT00494013|144650144|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority margin of 1.5 kilograms (kg).|Mean Difference (Net)|1.5|||<|0.001||95.0|0.93|2.06||P-value for Change from Baseline.|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline + Country + Baseline HbA1c + Baseline Sulfonylurea Group.|The two-sided 95% confidence interval is for the Least Squares Mean difference between the two treatments (Insulin Lispro Protamine Suspension minus Determir).|The second gatekeeping hypothesis was that Insulin Lispro Protamine Suspension was noninferior to detemir with regard to change in absolute body weight from baseline to endpoint (last observation carried forward).||2.06|0.93|<0.001
72559870|NCT00494013|144650145|SUPERIORITY_OR_OTHER|||||||0.074||95.0|||||ANCOVA|ANCOVA Model: Variable=Treatment + Country + Baseline HbA1c + Baseline Sulfonylurea Group + Change in HbA1c from Baseline.||||||0.074
72559871|NCT00494013|144650146|SUPERIORITY_OR_OTHER|||||||0.039||95.0|||||ANCOVA|ANCOVA Model: Variable=Treatment + Country + Baseline HbA1c + Baseline Sulfonylurea Group + Change in HbA1c from Baseline.||||||0.039
72443178|NCT04950127|144399467|SUPERIORITY|Symptoms|Mean Difference (Net)|0.45||||0.318|TWO_SIDED|95.0|-0.44|1.34||Not adjusted for multiplicity; two-sided p- values \<0.05 were considered to be nominally significant as per SAP.|Mixed Models Analysis|Mixed Model Repeated Measures Analysis||The mixed model repeated measures analysis includes Treatment Group, Visit, Visit\*Treatment Group interaction, Baseline PBC-40 domain scores, Visit\*Baseline PBC-40 domain scores interaction, Baseline Concomitant Itch Medication.||1.34|-0.44|0.318
72443179|NCT04950127|144399468|SUPERIORITY||Mean Difference (Net)|-0.37|||<|0.001|TWO_SIDED|95.0|-0.55|-0.2||Not adjusted for multiplicity; two-sided p- values \<0.05 were considered to be nominally significant as per SAP.|Mixed Models Analysis|Mixed Model Repeated Measures Analysis||The mixed model repeated measures analysis includes Treatment Group, Visit, Visit\*Treatment Group interaction, Baseline PGI-S score, Visit\*Baseline PGI-S score interaction, Baseline Concomitant Itch Medication.||-0.20|-0.55|<0.001
72559872|NCT00494013|144650147|SUPERIORITY_OR_OTHER|||||||0.026||95.0|||||Fisher Exact|||||||0.026
72443180|NCT04950127|144399469|SUPERIORITY||Mean Difference (Net)|-0.49|||<|0.001|TWO_SIDED|95.0|-0.76|-0.21||Not adjusted for multiplicity; two-sided p- values \<0.05 were considered to be nominally significant as per SAP.|Mixed Models Analysis|Mixed Model Repeated Measures Analysis||The mixed model repeated measures analysis includes Treatment Group, Visit, Visit\*Treatment Group interaction, Baseline Concomitant Itch Medication.||-0.21|-0.76|<0.001
72443181|NCT05064735|144399493|SUPERIORITY||Estimated Treatment Difference|-10.48|||<|0.0001|TWO_SIDED|95.0|-12.34|-8.63|||ANCOVA|||The responses at week 68 were analyzed using an analysis of covariance model with randomized treatment as factor and baseline body weight as covariate.||-8.63|-12.34|<0.0001
72559873|NCT00919711|144650151|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|1.6|||<|0.0001|TWO_SIDED|95.0|1.2|2.0|||ANCOVA||Denosumab - Risedronate|||2.0|1.2|<0.0001
72559874|NCT00919711|144650152|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
72443182|NCT05064735|144399494|SUPERIORITY||Estimated Treatment Difference|-14.14|||<|0.0001|TWO_SIDED|95.0|-19.98|-8.3|||ANCOVA|||The responses at week 68 were analyzed using an analysis of covariance model with randomized treatment as factor and baseline WOMAC pain score as covariate.||-8.30|-19.98|<0.0001
72443183|NCT02376790|144399527|SUPERIORITY||Treatment Difference|13.9||||0.005|TWO_SIDED|95.0|5.8|22.0||Adjusted p-value was obtained by applying a Bonferroni-based testing procedure for multiplicity adjustment to control the family-wise, two-sided type one error rate at 0.05.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test with baseline body mass index (≤ 30 kg/m² or \> 30 kg/m²) and prior non-biologic DMARD treatment as stratification factors|The risk difference was estimated using the Mantel-Haenszel estimate of common risk difference using the stratification factors described above.|The primary hypothesis of this study is that etanercept plus methotrexate therapy and etanercept monotherapy are more efficacious than methotrexate monotherapy as measured by the percentage of participants with psoriatic arthritis achieving ACR 20 response at week 24.||22.0|5.8|0.005
72496741|NCT02867761|144522895|SUPERIORITY|||||||0.84|||||||Linear Mixed Effects Model|||P Value for percentage of days with use of albuterol.||||0.84
72559875|NCT00919711|144650153|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|1.4|||<|0.0001|TWO_SIDED|95.0|0.9|1.8|||ANCOVA||Denosumab - Risedronate|||1.8|0.9|<0.0001
72559876|NCT00919711|144650154|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|2.3|||<|0.0001|TWO_SIDED|95.0|1.8|2.8|||ANCOVA||Denosumab - Risedronate|||2.8|1.8|<0.0001
72559877|NCT00087529|144650155|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.773||||0.1442|TWO_SIDED|95.0|0.546|1.093||Stratified using the following variables: Baseline EDSS (less than or equal to \[≤\] 4.0 versus \>4.0 points) and prior treatment with interferon-beta or glatiramer acetate.|Log Rank|||||1.093|0.546|0.1442
72559878|NCT00087529|144650157|SUPERIORITY_OR_OTHER||LS mean difference|-718.24||||0.0008|TWO_SIDED|95.0|-1504.48|68.0|||Friedman ranked ANOVA test|||Treatment difference in least-squares (LS) means and the associated 95% confidence intervals were estimated from the analysis of variance (ANOVA) model, which included the following factors: Baseline EDSS (≤ 4.0 versus \>4.0 points), prior treatment with interferon-beta or glatiramer acetate, and treatment group.||68.00|-1504.48|0.0008
72559879|NCT00087529|144650158|SUPERIORITY_OR_OTHER||LS mean difference|-1.08||||0.6237|TWO_SIDED|95.0|-9.49|7.34|||Friedman ranked ANOVA test|||Treatment difference in LS means and the associated 95% confidence intervals were estimated from the ANOVA model, which included the following factors: Baseline EDSS (≤ 4.0 versus \>4.0 points), prior treatment with interferon-beta or glatiramer acetate, and treatment group.||7.34|-9.49|0.6237
72559880|NCT02466087|144650179|OTHER||diiference in differences|1.5|||||TWO_SIDED|95.0|||||Regression, Linear|||||||
72559881|NCT02856594|144650185|SUPERIORITY||Odds Ratio (OR)|0.32||||0.029|TWO_SIDED|95.0|0.1|0.83|||Regression, Logistic|||||0.83|0.10|0.029
72496742|NCT04506294|144522903|SUPERIORITY|||||||0.536|||||||t-test, 2 sided|||||||.536
72496743|NCT00428597|144522953|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.418||||0.000118|TWO_SIDED|95.0|0.263|0.662||Log-rank test statistic and 2-sided p-value from the unstratified log-rank test|Log Rank||Hazard ratio based on the Cox Proportional hazards model|||0.662|0.263|0.000118
72496744|NCT00428597|144522954|SUPERIORITY_OR_OTHER||Objective Response Rate (ORR) (percent)|9.3|||||TWO_SIDED|95.0|4.1|17.5|||||Confidence interval (CI) using exact method based on binomial distribution.|||17.5|4.1|
72559882|NCT02856594|144650187|SUPERIORITY||Odds Ratio (OR)|0.96||||0.24|TWO_SIDED|95.0|0.89|1.03|||Regression, Linear|||||1.03|0.89|0.24
72559883|NCT01884844|144650198|SUPERIORITY|||||||0.89|||||||Fisher Exact|||||||0.89
72443184|NCT02376790|144399527|SUPERIORITY||Treatment Difference|9.2||||0.029|TWO_SIDED|95.0|1.0|17.3||Adjusted p-value was obtained by applying a Bonferroni-based testing procedure for multiplicity adjustment to control the family-wise, two-sided type one error rate at 0.05.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test with baseline body mass index (≤ 30 kg/m² or \> 30 kg/m²) and prior non-biologic DMARD treatment as stratification factors|The risk difference was estimated using the Mantel-Haenszel estimate of common risk difference using the stratification factors described above.|The primary hypothesis of this study is that etanercept plus methotrexate therapy and etanercept monotherapy are more efficacious than methotrexate monotherapy as measured by the percentage of participants with psoriatic arthritis achieving ACR 20 response at week 24.||17.3|1.0|0.029
72443185|NCT02376790|144399528|SUPERIORITY||Treatment Difference|12.2||||0.005|TWO_SIDED|95.0|4.9|19.6||Adjusted p-value was obtained by applying a Bonferroni-based testing procedure for multiplicity adjustment to control the family-wise, two-sided type one error rate at 0.05.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test with baseline body mass index (≤ 30 kg/m² or \> 30 kg/m²) and prior non-biologic DMARD treatment as stratification factors|The risk difference was estimated using the Mantel-Haenszel estimate of common risk difference using the stratification factors described above.|The secondary hypothesis of this study was that etanercept plus methotrexate therapy and etanercept monotherapy are more efficacious than methotrexate monotherapy as measured by the percentage of participants with PsA achieving MDA response at week 24.||19.6|4.9|0.005
72443186|NCT02376790|144399528|SUPERIORITY||Treatment Difference|11.6||||0.005|TWO_SIDED|95.0|4.2|18.9||Adjusted p-value was obtained by applying a Bonferroni-based testing procedure for multiplicity adjustment to control the family-wise, two-sided type one error rate at 0.05.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test with baseline body mass index (≤ 30 kg/m² or \> 30 kg/m²) and prior non-biologic DMARD treatment as stratification factors|The risk difference was estimated using the Mantel-Haenszel estimate of common risk difference using the stratification factors described above.|The secondary hypothesis of this study was that etanercept plus methotrexate therapy and etanercept monotherapy are more efficacious than methotrexate monotherapy as measured by the percentage of participants with PsA achieving MDA response at week 24.||18.9|4.2|0.005
72443187|NCT02376790|144399530|SUPERIORITY||Treatment Difference|14.7|||<|0.001|TWO_SIDED|95.0|6.4|23.0||P-value is unadjusted and considered descriptive.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test with baseline body mass index (≤ 30 kg/m² or \> 30 kg/m²) and prior non-biologic DMARD treatment as stratification factors|The risk difference was estimated using the Mantel-Haenszel estimate of common risk difference using the stratification factors described above.|Analysis of the percentage of participants with an ACR50 response at week 24.||23.0|6.4|<0.001
72443188|NCT02376790|144399530|SUPERIORITY||Treatment Difference|11.8||||0.006|TWO_SIDED|95.0|3.4|20.2||P-value is unadjusted and considered descriptive.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test with baseline body mass index (≤ 30 kg/m² or \> 30 kg/m²) and prior non-biologic DMARD treatment as stratification factors|The risk difference was estimated using the Mantel-Haenszel estimate of common risk difference using the stratification factors described above.|Analysis of the percentage of participants with an ACR50 response at week 24.||20.2|3.4|0.006
72443189|NCT02376790|144399531|SUPERIORITY||Treatment Difference|13.4|||<|0.001|TWO_SIDED|95.0|6.5|20.4||P-value is unadjusted and considered descriptive.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test with baseline body mass index (≤ 30 kg/m² or \> 30 kg/m²) and prior non-biologic DMARD treatment as stratification factors|The risk difference was estimated using the Mantel-Haenszel estimate of common risk difference using the stratification factors described above.|Analysis of the percentage of participants with an ACR70 response at week 24.||20.4|6.5|<0.001
72496745|NCT00428597|144522957|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.409||||0.0204|TWO_SIDED|95.0|0.187|0.894||2-sided p-value from the unstratified log-rank test.|Log Rank||Hazard ratio based on the Cox Proportional hazards model.|||0.894|0.187|0.0204
72496746|NCT00428597|144522958|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.1543||||0.6799|TWO_SIDED|95.0|-4.3|6.6||From repeated measures mixed-effects with intercept term, treatment, time from first dose, treatment-by-time interaction and baseline score (intercept and time from dose as random effects). No p-value adjustments were made for multiple comparisons.|Repeated Measures Mixed-Effects Model||Estimated mean difference with 95% CI and p-value were obtained from the repeated measures mixed-effects model using data from Cycle 2 through Cycle 10.|Cycle 2 through Cycle 10||6.6|-4.3|0.6799
72496747|NCT00428597|144522959|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.4404||||0.6058|TWO_SIDED|95.0|-6.9|4.0||From repeated measures mixed-effects with intercept term, treatment, time from first dose, treatment-by-time interaction and baseline score (intercept and time from dose as random effects). No p-value adjustments were made for multiple comparisons.|Repeated Measures Mixed-Effects Model||Estimated mean difference with 95% CI and p-value were obtained from the repeated measures mixed-effects model using data from Cycle 2 through Cycle 10.|Cycle 2 through Cycle 10||4|-6.9|0.6058
72496748|NCT00428597|144522960|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.5575||||0.3008|TWO_SIDED|95.0|-10.3|3.2||From repeated measures mixed-effects with intercept term, treatment, time from first dose, treatment-by-time interaction and baseline score (intercept and time from dose as random effects). No p-value adjustments were made for multiple comparisons.|Repeated Measures Mixed-Effects Model||Estimated mean difference with 95% CI and p-value were obtained from the repeated measures mixed-effects model using data from Cycle 2 through Cycle 10.|Cycle 2 through Cycle 10||3.2|-10.3|0.3008
72496749|NCT00428597|144522961|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.7911||||0.323|TWO_SIDED|95.0|-2.8|8.3||From repeated measures mixed-effects with intercept term, treatment, time from first dose, treatment-by-time interaction and baseline score (intercept and time from dose as random effects). No p-value adjustments were made for multiple comparisons.|Repeated Measures Mixed-Effects Model||Estimated mean difference with 95% CI and p-value were obtained from the repeated measures mixed-effects model using data from Cycle 2 through Cycle 10.|Cycle 2 through Cycle 10||8.3|-2.8|0.3230
72504768|NCT03114969|144540505|SUPERIORITY||Odds Ratio (OR)|2.523||||0.007|TWO_SIDED|95.0|1.283|4.961||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator.|||4.961|1.283|0.007
72443190|NCT02376790|144399531|SUPERIORITY||Treatment Difference|13.7|||<|0.001|TWO_SIDED|95.0|6.7|20.7||P-value is unadjusted and considered descriptive.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test with baseline body mass index (≤ 30 kg/m² or \> 30 kg/m²) and prior non-biologic DMARD treatment as stratification factors|The risk difference was estimated using the Mantel-Haenszel estimate of common risk difference using the stratification factors described above.|Analysis of the percentage of participants with an ACR70 response at week 24.||20.7|6.7|<0.001
72443191|NCT02376790|144399540|SUPERIORITY||LS Mean Treatment Difference|-0.62|STANDARD_ERROR_OF_MEAN|0.14|<|0.001|TWO_SIDED|95.0|-0.91|-0.34||P-value is unadjusted and considered descriptive.|ANCOVA|ANCOVA model adjusted for baseline BMI status (≤ 30 kg/m² or \> 30 kg/m²) and prior non-biologic DMARD use.|Methotrexate Monotherapy is the reference|Analysis of change from baseline in PASDAS at week 24||-0.34|-0.91|<0.001
72443192|NCT02376790|144399540|SUPERIORITY||LS Mean Treatment Difference|-0.63|STANDARD_ERROR_OF_MEAN|0.15|<|0.001|TWO_SIDED|95.0|-0.92|-0.34||P-value is unadjusted and considered descriptive|ANCOVA|ANCOVA model adjusted for baseline BMI status (≤ 30 kg/m² or \>30 kg/m²) and prior non-biologic DMARD use.|Methotrexate Monotherapy is the reference|Analysis of change from baseline in PASDAS at week 24||-0.34|-0.92|<0.001
72443193|NCT02376790|144399541|SUPERIORITY||LS Mean Treatment Difference|-0.63|STANDARD_ERROR_OF_MEAN|1.18||0.59|TWO_SIDED|95.0|-2.93|1.68||P-value is unadjusted and considered descriptive|ANCOVA|ANCOVA model adjusted for baseline BMI status (≤ 30 kg/m² or \> 30 kg/m²) and prior non-biologic DMARD use.|Methotrexate Monotherapy is the reference|Analysis of change from baseline in CDAI at week 24||1.68|-2.93|0.59
72443194|NCT02376790|144399541|SUPERIORITY||LS Mean Treatment Difference|-1.32|STANDARD_ERROR_OF_MEAN|1.18||0.26|TWO_SIDED|95.0|-3.63|0.99||P-value is unadjusted and considered descriptive.|ANCOVA|ANCOVA model adjusted for baseline BMI status (≤ 30 kg/m² or \> 30 kg/m²) and prior non-biologic DMARD use.|Methotrexate Monotherapy is the reference|Analysis of change from baseline in CDAI at week 24||0.99|-3.63|0.26
72443195|NCT02376790|144399542|SUPERIORITY||LS Mean Treatment Difference|-0.98|STANDARD_ERROR_OF_MEAN|1.2||0.41|TWO_SIDED|95.0|-3.35|1.38||P-value is unadjusted and considered descriptive|ANCOVA|ANCOVA model adjusted for baseline BMI status (≤ 30 kg/m² or \> 30 kg/m²) and prior non-biologic DMARD use.|Methotrexate Monotherapy is the reference|Analysis of change from baseline in SDAI at week 24||1.38|-3.35|0.41
72443196|NCT02376790|144399542|SUPERIORITY||LS Mean Treatment Difference|-1.72|STANDARD_ERROR_OF_MEAN|1.21||0.15|TWO_SIDED|95.0|-4.09|0.65||P-value is unadjusted and considered descriptive.|ANCOVA|ANCOVA model adjusted for baseline BMI status (≤ 30 kg/m² or \> 30 kg/m²) and prior non-biologic DMARD use.|Methotrexate Monotherapy is the reference|Analysis of change from baseline in SDAI at week 24||0.65|-4.09|0.15
72443197|NCT02376790|144399543|SUPERIORITY||LS Mean Treatment Difference|-0.29|STANDARD_ERROR_OF_MEAN|0.11||0.01|TWO_SIDED|95.0|-0.52|-0.07||P-value is unadjusted and considered descriptive.|ANCOVA|ANCOVA model adjusted for baseline BMI status (≤ 30 kg/m² or \>30 kg/m²) and prior non-biologic DMARD use.|Methotrexate Monotherapy is the reference|Analysis of change from baseline in DAS28 at week 24||-0.07|-0.52|0.010
72443198|NCT02376790|144399543|SUPERIORITY||LS Mean Treatment Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.12|<|0.001|TWO_SIDED|95.0|-0.62|-0.17||P-value is unadjusted and considered descriptive.|ANCOVA|ANCOVA model adjusted for baseline BMI status (≤ 30 kg/m² or \>30 kg/m²) and prior non-biologic DMARD use.|Methotrexate Monotherapy is the reference|Analysis of change from baseline in DAS28 at week 24||-0.17|-0.62|<0.001
72443199|NCT02376790|144399544|SUPERIORITY||LS Mean Treatment Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.05||0.34|TWO_SIDED|95.0|-0.15|0.05||P-value is unadjusted and considered descriptive.|ANCOVA|ANCOVA model adjusted for baseline BMI status (≤ 30 kg/m² or \>30 kg/m²) and prior non-biologic DMARD use.|Methotrexate Monotherapy is the reference|||0.05|-0.15|0.34
72443200|NCT02376790|144399544|SUPERIORITY||LS Mean Treatment Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.05||0.67|TWO_SIDED|95.0|-0.12|0.08||P-value is unadjusted and considered descriptive.|ANCOVA|ANCOVA model adjusted for baseline BMI status (≤ 30 kg/m² or \> 30 kg/m²) and prior non-biologic DMARD use.|Methotrexate Monotherapy is the reference|||0.08|-0.12|0.67
72443201|NCT02376790|144399545|SUPERIORITY||LS Mean Treatment Difference|1.94|STANDARD_ERROR_OF_MEAN|0.8||0.015|TWO_SIDED|95.0|0.37|3.51||P-value is unadjusted and considered descriptive.|ANCOVA|ANCOVA model adjusted for baseline BMI status (≤ 30 kg/m² or \>30 kg/m²) and prior non-biologic DMARD use.|Methotrexate Monotherapy is the reference|Analysis of change from baseline in Physical Component Summary at week 24||3.51|0.37|0.015
72496750|NCT00428597|144522962|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.5113||||0.7113|TWO_SIDED|95.0|-6.5|9.5||From repeated measures mixed-effects with intercept term, treatment, time from first dose, treatment-by-time interaction and baseline score (intercept and time from dose as random effects). No p-value adjustments were made for multiple comparisons.|Repeated Measures Mixed-Effects Model||Estimated mean difference with 95% CI and p-value were obtained from the repeated measures mixed-effects model using data from Cycle 2 through Cycle 10.|Cycle 2 through Cycle 10||9.5|-6.5|0.7113
72496751|NCT00428597|144522963|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.6672||||0.6487|TWO_SIDED|95.0|-8.9|5.5||From repeated measures mixed-effects with intercept term, treatment, time from first dose, treatment-by-time interaction and baseline score (intercept and time from dose as random effects). No p-value adjustments were made for multiple comparisons.|Repeated Measures Mixed-Effects Model||Estimated mean difference with 95% CI and p-value were obtained from the repeated measures mixed-effects model using data from Cycle 2 through Cycle 10.|Cycle 2 through Cycle 10||5.5|-8.9|0.6487
72496752|NCT00428597|144522964|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.88||||0.6545|TWO_SIDED|95.0|-6.4|10.1||From repeated measures mixed-effects with intercept term, treatment, time from first dose, treatment-by-time interaction and baseline score (intercept and time from dose as random effects). No p-value adjustments were made for multiple comparisons.|Repeated Measures Mixed-Effects Model||Estimated mean difference with 95% CI and p-value were obtained from the repeated measures mixed-effects model using data from Cycle 2 through Cycle 10.|Cycle 2 through Cycle 10||10.1|-6.4|0.6545
72443202|NCT02376790|144399545|SUPERIORITY||LS Mean Treatment Difference|1.71|STANDARD_ERROR_OF_MEAN|0.8||0.033|TWO_SIDED|95.0|0.13|3.28||P-value is unadjusted and considered descriptive.|ANCOVA|ANCOVA model adjusted for baseline BMI status (≤ 30 kg/m² or \> 30 kg/m²) and prior non-biologic DMARD use.|Methotrexate Monotherapy is the reference|Analysis of change from baseline in Physical Component Summary at week 24||3.28|0.13|0.033
72443203|NCT02376790|144399545|SUPERIORITY||LS Mean Treatment Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.84||0.97|TWO_SIDED|95.0|-1.69|1.63||P-value is unadjusted and considered descriptive.|ANCOVA|ANCOVA model adjusted for baseline BMI status (≤ 30 kg/m² or \> 30 kg/m²) and prior non-biologic DMARD use.|Methotrexate Monotherapy is the reference|Analysis of change from baseline in Mental Component Summary at week 24||1.63|-1.69|0.97
72559884|NCT00874822|144650207|SUPERIORITY_OR_OTHER_LEGACY||Percentage of Participants|19.0|STANDARD_ERROR_OF_MEAN|2.7|<|0.0001|TWO_SIDED|95.0|13.6|24.4|||Chi-squared, Corrected|||"Ho: The Prevalence of obstructive sleep apnea in patients planning hip or knee arthroplasty will be no different using current screening techniques than it was in a historical control group.~The prevalence of OSA in the study population is hypothesized to be at least 10% higher than the best previous estimate of 6.7%. Employing a two-sided hypothesis test with α of 0.05 and power of 0.85 yields a sample size of 163."||24.4|13.6|<0.0001
72443204|NCT02376790|144399545|SUPERIORITY||LS Mean Treatment Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.85||0.56|TWO_SIDED|95.0|-2.16|1.16||P-value is unadjusted and considered descriptive.|ANCOVA|ANCOVA model adjusted for baseline BMI status (≤ 30 kg/m² or \> 30 kg/m²) and prior non-biologic DMARD use.|Methotrexate Monotherapy is the reference|Analysis of change from baseline in Mental Component Summary at week 24||1.16|-2.16|0.56
72443205|NCT02376790|144399546|SUPERIORITY||LS Mean Treatment Difference|-0.56|STANDARD_ERROR_OF_MEAN|0.24||0.02|TWO_SIDED|95.0|-1.03|-0.09||P-value is unadjusted and considered descriptive.|ANCOVA|ANCOVA model adjusted for baseline BMI status (≤ 30 kg/m² or \>30 kg/m²) and prior non-biologic DMARD use.|Methotrexate Monotherapy is the reference|||-0.09|-1.03|0.020
72443206|NCT02376790|144399546|SUPERIORITY||LS Mean Treatment Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.24||0.1|TWO_SIDED|95.0|-0.88|0.08||P-value is unadjusted and considered descriptive.|ANCOVA|ANCOVA model adjusted for baseline BMI status (≤ 30 kg/m² or \> 30 kg/m²) and prior non-biologic DMARD use.|Methotrexate Monotherapy is the reference|||0.08|-0.88|0.10
72443207|NCT02376790|144399548|SUPERIORITY||LS Mean Treatment Difference|13.92|STANDARD_ERROR_OF_MEAN|33.23||0.68|TWO_SIDED|95.0|-51.52|79.36||P-value is unadjusted and considered descriptive.|ANCOVA|ANCOVA model adjusted for baseline BMI status (≤ 30 kg/m² or \>30 kg/m²) and prior non-biologic DMARD use.|Methotrexate Monotherapy is the reference|||79.36|-51.52|0.68
72443208|NCT02376790|144399548|SUPERIORITY||LS Mean Treatment Difference|6.34|STANDARD_ERROR_OF_MEAN|33.05||0.85|TWO_SIDED|95.0|-58.75|71.42||P-value is unadjusted and considered descriptive.|ANCOVA|ANCOVA model adjusted for baseline BMI status (≤ 30 kg/m² or \> 30 kg/m²) and prior non-biologic DMARD use.|Methotrexate Monotherapy is the reference|||71.42|-58.75|0.85
72443209|NCT02376790|144399549|SUPERIORITY||Treatment Difference|12.9||||0.057|TWO_SIDED|95.0|-0.4|26.2||P-value is unadjusted and considered descriptive.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test with baseline body mass index (≤ 30 kg/m² or \> 30 kg/m²) and prior non-biologic DMARD treatment as stratification factors|The risk difference was estimated using the Mantel-Haenszel estimate of common risk difference using the stratification factors described above.|||26.2|-0.4|0.057
72443210|NCT02376790|144399549|SUPERIORITY||Treatment Difference|10.9||||0.12|TWO_SIDED|95.0|-2.5|24.4||P-value is unadjusted and considered descriptive.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test with baseline body mass index (≤ 30 kg/m² or \> 30 kg/m²) and prior non-biologic DMARD treatment as stratification factors|The risk difference was estimated using the Mantel-Haenszel estimate of common risk difference using the stratification factors described above.|||24.4|-2.5|0.12
72443211|NCT02376790|144399550|SUPERIORITY||LS Mean Treatment Difference|0.16|STANDARD_ERROR_OF_MEAN|0.42||0.7|TWO_SIDED|95.0|-0.66|0.98||P-value is unadjusted and considered descriptive.|ANCOVA|ANCOVA model adjusted for baseline BMI status (≤ 30 kg/m² or \>30 kg/m²) and prior non-biologic DMARD use.|Methotrexate Monotherapy is the reference|||0.98|-0.66|0.70
72443212|NCT02376790|144399550|SUPERIORITY||LS Mean Treatment Difference|0.04|STANDARD_ERROR_OF_MEAN|0.42||0.93|TWO_SIDED|95.0|-0.79|0.86||P-value is unadjusted and considered descriptive.|ANCOVA|ANCOVA model adjusted for baseline BMI status (≤ 30 kg/m² or \> 30 kg/m²) and prior non-biologic DMARD use.|Methotrexate Monotherapy is the reference|||0.86|-0.79|0.93
72443213|NCT02376790|144399551|SUPERIORITY||Treatment Difference|3.2||||0.55|TWO_SIDED|95.0|-7.3|13.7||P-value is unadjusted and considered descriptive.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test with baseline body mass index (≤ 30 kg/m² or \> 30 kg/m²) and prior non-biologic DMARD treatment as stratification factors|The risk difference was estimated using the Mantel-Haenszel estimate of common risk difference using the stratification factors described above.|||13.7|-7.3|0.55
72559885|NCT04281472|144650253|SUPERIORITY||Hazard Ratio (HR)|0.394|||||TWO_SIDED|95.0|0.253|0.614||||||||0.614|0.253|
72559886|NCT05053360|144650305|SUPERIORITY||Odds Ratio (OR)|2.87||||0.019|TWO_SIDED|95.0|1.19|6.93|||Regression, Logistic|||HIGH PAIN = score over 6 on a 0-10 pain scale (higher number indicating higher pain)||6.93|1.19|.019
72443214|NCT02376790|144399551|SUPERIORITY||Treatment Difference|8.8||||0.11|TWO_SIDED|95.0|-1.9|19.4||P-value is unadjusted and considered descriptive.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test with baseline body mass index (≤ 30 kg/m² or \> 30 kg/m²) and prior non-biologic DMARD treatment as stratification factors|The risk difference was estimated using the Mantel-Haenszel estimate of common risk difference using the stratification factors described above.|||19.4|-1.9|0.11
72443215|NCT02376790|144399552|SUPERIORITY||LS Mean Treatment Difference|9.36|STANDARD_ERROR_OF_MEAN|4.33||0.031|TWO_SIDED|95.0|0.85|17.87||P-value is unadjusted and considered descriptive.|ANCOVA|ANCOVA model adjusted for baseline BMI status (≤ 30 kg/m² or \>30 kg/m²) and prior non-biologic DMARD use.|Methotrexate Monotherapy is the reference|||17.87|0.85|0.031
72443216|NCT02376790|144399552|SUPERIORITY||LS Mean Treatment Difference|3.02|STANDARD_ERROR_OF_MEAN|4.33||0.49|TWO_SIDED|95.0|-5.49|11.54||P-value is unadjusted and considered descriptive.|ANCOVA|ANCOVA model adjusted for baseline BMI status (≤ 30 kg/m² or \> 30 kg/m²) and prior non-biologic DMARD use.|Methotrexate Monotherapy is the reference|||11.54|-5.49|0.49
72443217|NCT02376790|144399553|SUPERIORITY||LS Mean Treatment Difference|15.95|STANDARD_ERROR_OF_MEAN|4.55|<|0.001|TWO_SIDED|95.0|6.99|24.9||P-value is unadjusted and considered descriptive.|ANCOVA|ANCOVA model adjusted for baseline BMI status (≤ 30 kg/m² or \> 30 kg/m²) and prior non-biologic DMARD use.|Methotrexate Monotherapy is the reference|Analysis of percent improvement from baseline in the percentage of BSA involved in psoriasis in the subgroup of participants with ≥ 10% BSA involvement at baseline.||24.90|6.99|<0.001
72559887|NCT05053360|144650306|SUPERIORITY||Mean Difference (Final Values)|-2.28||||0.0002|TWO_SIDED|95.0|-3.47|-1.09|||ANCOVA|||||-1.09|-3.47|.0002
72443218|NCT02376790|144399553|SUPERIORITY||LS Mean Treatment Difference|6.97|STANDARD_ERROR_OF_MEAN|4.5||0.12|TWO_SIDED|95.0|-1.89|15.83||P-value is unadjusted and considered descriptive.|ANCOVA|ANCOVA model adjusted for baseline BMI status (≤ 30 kg/m² or \> 30 kg/m²) and prior non-biologic DMARD use.|Methotrexate Monotherapy is the reference|Analysis of percent improvement from baseline in the percentage of BSA involved in psoriasis in the subgroup of participants with ≥ 10% BSA involvement at baseline.||15.83|-1.89|0.12
72388555|NCT02195583|144285290|SUPERIORITY_OR_OTHER||Mean Difference (Net)|9.26|||<|0.0001|TWO_SIDED|95.0|6.77|11.75|||ANOVA|Calculated from ANOVA model using treatment and study period as fixed factors and participant as random effect.|Difference was calculated as Sodium fluoride (1426 ppm) minus 'Sodium fluoride (1426ppm) + zinc base B' such that a positive difference favors Sodium fluoride (1426 ppm).|||11.75|6.77|<0.0001
72388556|NCT01709513|144285294|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-30.4|||<|0.0001|TWO_SIDED|95.0|-36.6|-24.2||Threshold for significance ≤ 0.05.|Mixed Models Analysis|||Alirocumab group was compared to the corresponding active control group using an appropriate contrast statement.||-24.2|-36.6|<0.0001
72388557|NCT01709513|144285295|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-35.1|||<|0.0001|TWO_SIDED|95.0|-40.7|-29.5||Threshold for significance ≤ 0.05.|Mixed Models Analysis|||A hierarchical testing procedure was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when previous endpoint was statistically significant at 5% level.||-29.5|-40.7|<0.0001
72388558|NCT01709513|144285296|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-31.5|||<|0.0001|TWO_SIDED|95.0|-36.9|-26.1||Threshold for significance ≤ 0.05.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).||-26.1|-36.9|<0.0001
72388559|NCT01709513|144285297|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-33.1|||<|0.0001|TWO_SIDED|95.0|-38.0|-28.2||Threshold for significance ≤ 0.05.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).||-28.2|-38.0|<0.0001
72388560|NCT01709513|144285298|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-25.1|||<|0.0001|TWO_SIDED|95.0|-29.8|-20.4||Threshold for significance ≤ 0.05.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).||-20.4|-29.8|<0.0001
72388561|NCT01709513|144285299|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-28.2|||<|0.0001|TWO_SIDED|95.0|-32.1|-24.4||Threshold for significance ≤ 0.05.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).||-24.4|-32.1|<0.0001
72388562|NCT01709513|144285300|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-25.6|||<|0.0001|TWO_SIDED|95.0|-30.4|-20.8||Threshold for significance ≤ 0.05.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).||-20.8|-30.4|<0.0001
72388563|NCT01709513|144285301|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-29.8|||<|0.0001|TWO_SIDED|95.0|-33.9|-25.8||Threshold for significance ≤ 0.05.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).||-25.8|-33.9|<0.0001
72388564|NCT01709513|144285302|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-20.8|||<|0.0001|TWO_SIDED|95.0|-24.7|-17.0||Threshold for significance ≤ 0.05.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).||-17.0|-24.7|<0.0001
72388565|NCT01709513|144285303|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-24.5|||<|0.0001|TWO_SIDED|95.0|-28.7|-20.4||Threshold for significance ≤ 0.05.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).||-20.4|-28.7|<0.0001
72388566|NCT01709513|144285304|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-25.7|||<|0.0001|TWO_SIDED|95.0|-29.9|-21.5||Threshold for significance ≤ 0.05.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).||-21.5|-29.9|<0.0001
72388567|NCT01709513|144285305|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-21.1|||<|0.0001|TWO_SIDED|95.0|-24.5|-17.7||Threshold for significance ≤ 0.05.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).||-17.7|-24.5|<0.0001
72388568|NCT01709513|144285306|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|19.5|||<|0.0001|TWO_SIDED|95.0|6.9|55.2||Threshold for significance ≤ 0.05.|Regression, Logistic|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant). Statistical analysis used a multiple imputation approach followed by a Logistic regression model.||55.2|6.9|<0.0001
72388569|NCT01709513|144285307|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|24.9|||<|0.0001|TWO_SIDED|95.0|8.6|71.9||Threshold for significance ≤ 0.05.|Regression, Logistic|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant). Statistical analysis used a multiple imputation approach followed by a Logistic regression model.||71.9|8.6|<0.0001
72504769|NCT03114969|144540506|SUPERIORITY||Odds Ratio (OR)|2.399||||0.008|TWO_SIDED|95.0|1.252|4.596||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta+\[Relvar Ellipta+LAMA\] as comparator.|||4.596|1.252|0.008
72388570|NCT01709513|144285308|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|71.5|||<|0.0001|TWO_SIDED|95.0|11.1|3022.1||Threshold for significance ≤ 0.05.|Regression, Exact Conditional Logistic|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant). Statistical analysis used a last observation carried forward (LOCF) approach followed by Exact conditional logistic regression model.||3022.1|11.1|<0.0001
72388571|NCT01709513|144285309|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|109.8|||<|0.0001|TWO_SIDED|95.0|16.5|4759.3||Threshold for significance ≤ 0.05.|Regression, Exact Conditional Logistic|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant). Statistical analysis used a LOCF approach followed by Exact conditional logistic regression model.||4759.3|16.5|<0.0001
72504770|NCT03114969|144540506|SUPERIORITY||Odds Ratio (OR)|1.812||||0.082|TWO_SIDED|95.0|0.926|3.544||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta+\[Relvar Ellipta+LAMA\] as comparator.|||3.544|0.926|0.082
72443219|NCT02376790|144399558|SUPERIORITY||Treatment Difference|11.4||||0.019|TWO_SIDED|95.0|2.0|20.8||P-value is unadjusted and considered descriptive.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test with baseline body mass index (≤ 30 kg/m² or \> 30 kg/m²) and prior non-biologic DMARD treatment as stratification factors|The risk difference was estimated using the Mantel-Haenszel estimate of common risk difference using the stratification factors described above.|||20.8|2.0|0.019
72559888|NCT03807440|144650313|OTHER||||||<|0.0001|||||||Kruskal-Wallis|||||||<.0001
72443220|NCT02376790|144399558|SUPERIORITY||Treatment Difference|4.2||||0.4|TWO_SIDED|95.0|-5.6|14.0||P-value is unadjusted and considered descriptive.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test with baseline body mass index (≤ 30 kg/m² or \> 30 kg/m²) and prior non-biologic DMARD treatment as stratification factors|The risk difference was estimated using the Mantel-Haenszel estimate of common risk difference using the stratification factors described above.|||14.0|-5.6|0.40
72443221|NCT02376790|144399559|SUPERIORITY||Treatment Difference|20.1||||0.004|TWO_SIDED|95.0|6.8|33.3||P-value is unadjusted and considered descriptive.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test with baseline body mass index (≤ 30 kg/m² or \> 30 kg/m²) and prior non-biologic DMARD treatment as stratification factors|The risk difference was estimated using the Mantel-Haenszel estimate of common risk difference using the stratification factors described above.|Analysis of percentage of participants with an sPGA of 0 or 1 at Week 24 in participants with baseline BSA involvement with psoriasis ≥ 10%.||33.3|6.8|0.004
72443222|NCT02376790|144399559|SUPERIORITY||Treatment Difference|17.1||||0.012|TWO_SIDED|95.0|4.0|30.2||P-value is unadjusted and considered descriptive.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test with baseline body mass index (≤ 30 kg/m² or \> 30 kg/m²) and prior non-biologic DMARD treatment as stratification factors|The risk difference was estimated using the Mantel-Haenszel estimate of common risk difference using the stratification factors described above.|Analysis of percentage of participants with an sPGA of 0 or 1 at Week 24 in participants with baseline BSA involvement with psoriasis ≥ 10%.||30.2|4.0|0.012
72443223|NCT05450458|144399565|OTHER|This study assessed longitudinal effects within a single patient group. Statistical power was calculated using a significance level of 0.05, 80% power, and 60 patients, accounting for KOOS score variability over time. The Friedman test was applied with post hoc analyses (Conover and Bonferroni). Since treatments were not compared, no non-inferiority or equivalence margin was defined|Median Change Baseline to month 6|0.22|||<|0.001|TWO_SIDED|95.0|0.15|0.23||P-values were adjusted for multiple comparisons using the Bonferroni method, and the a priori threshold for statistical significance was set at 0.05.|Friedman Test|Post hoc pairwise comparisons were adjusted using the Bonferroni method, and the a priori significance level was set at 0.05|The value represents the intra-individual median KOOS improvement from baseline to month 6 after treatment. Changes were evaluated across time points within a single cohort.|The statistical analysis will use the Friedman test, as the Shapiro-Wilk test confirmed a non-normal distribution. Conover's post hoc test with Bonferroni correction will adjust for multiple comparisons. The null hypothesis states that hyaluronic acid injections with sorbitol do not significantly improve KOOS function and pain scores over time. A power analysis was performed to ensure an adequate sample size for detecting clinically meaningful differences.||0.23|0.15|<0.001
72443224|NCT05450458|144399566|OTHER|This study assessed longitudinal effects within a single patient group. Statistical power was calculated using a significance level of 0.05, 80% power, and 60 patients, accounting for IKDC score variability over time. The Friedman test was applied with post hoc analyses (Conover and Bonferroni). Since treatments were not compared, no non-inferiority or equivalence margin was defined|Median Baseline to Month 6|0.18||||0.01|TWO_SIDED|95.0|0.12|0.24||P-values were adjusted for multiple comparisons using the Bonferroni method, and the a priori threshold for statistical significance was set at 0.05.|Friedman Test|The overall p-value is unadjusted. The a priori significance level was set at 0.05 to robustly control the Type I error|This value represents the intra-individual median IKDC improvement from baseline to 6 months after treatment. The analysis was conducted within a single cohort without comparator arms.|The statistical analysis will use the Friedman test, as the Shapiro-Wilk test confirmed a non-normal distribution. Conover's post hoc test with Bonferroni correction will adjust for multiple comparisons. The null hypothesis states that hyaluronic acid injections with sorbitol do not significantly improve IKDC function and pain scores over time. A power analysis was performed to ensure an adequate sample size for detecting clinically meaningful differences.||0.24|0.12|0.01
72496753|NCT00428597|144522965|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.0035||||0.1936|TWO_SIDED|95.0|-10.0|2.0||From repeated measures mixed-effects with intercept term, treatment, time from first dose, treatment-by-time interaction and baseline score (intercept and time from dose as random effects). No p-value adjustments were made for multiple comparisons.|Repeated Measures Mixed-Effects Model||Estimated mean difference with 95% CI and p-value were obtained from the repeated measures mixed-effects model using data from Cycle 2 through Cycle 10.|Cycle 2 through Cycle 10||2|-10|0.1936
72496754|NCT00428597|144522966|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|21.3801|||<|0.0001|TWO_SIDED|95.0|14.3|28.4||From repeated measures mixed-effects with intercept term, treatment, time from first dose, treatment-by-time interaction and baseline score (intercept and time from dose as random effects). No p-value adjustments were made for multiple comparisons.|Repeated Measures Mixed-Effects Model||Estimated mean difference with 95% CI and p-value were obtained from the repeated measures mixed-effects model using data from Cycle 2 through Cycle 10.|Cycle 2 through Cycle 10||28.4|14.3|<0.0001
72559889|NCT03807440|144650314|OTHER||||||<|0.0001|||||||Chi-squared|||||||<.0001
72559890|NCT03807440|144650315|OTHER||||||<|0.0001|||||||Kruskal-Wallis|||||||<.0001
72559891|NCT03807440|144650316|OTHER|||||||0.8071|||||||Chi-squared|||||||0.8071
72559892|NCT03807440|144650316|OTHER|||||||0.764|||||||Fisher Exact|||||||0.7640
72559893|NCT03807440|144650317|OTHER||||||<|0.0001|||||||Kruskal-Wallis|||||||<.0001
72559894|NCT03807440|144650318|OTHER|||||||0.0042|||||||Chi-squared|||||||0.0042
72559895|NCT03807440|144650319|OTHER||||||<|0.0001|||||||Kruskal-Wallis|||||||<.0001
72559896|NCT03807440|144650320|OTHER|||||||0.399|||||||Chi-squared|||||||0.3990
72559897|NCT03807440|144650320|OTHER|||||||0.3842|||||||Fisher Exact|||||||0.3842
72559898|NCT03807440|144650321|OTHER|||||||0.0605|||||||Kruskal-Wallis|||||||0.0605
72559899|NCT03807440|144650322|OTHER|||||||0.6329|||||||Chi-squared|||||||0.6329
72559900|NCT03807440|144650322|OTHER|||||||0.7181|||||||Fisher Exact|||||||0.7181
72559901|NCT03807440|144650323|OTHER|||||||0.5233|||||||Kruskal-Wallis|||||||0.5233
72559902|NCT03807440|144650325|OTHER|||||||0.3662|||||||Kruskal-Wallis|||||||0.3662
72559903|NCT03807440|144650326|OTHER|||||||0.511|||||||Kruskal-Wallis|||||||0.5110
72559904|NCT03807440|144650327|OTHER|||||||0.0921|||||||Kruskal-Wallis|||||||0.0921
72559905|NCT03807440|144650328|OTHER||||||<|0.0001|||||||Kruskal-Wallis|||||||<.0001
72559906|NCT03807440|144650329|OTHER||||||<|0.0001|||||||Chi-squared|||||||<.0001
72559907|NCT03807440|144650330|OTHER||||||<|0.0001|||||||Kruskal-Wallis|||||||<.0001
72559908|NCT03807440|144650331|OTHER||||||<|0.0001|||||||Chi-squared|||||||<.0001
72559909|NCT03807440|144650332|OTHER|||||||0.3201|||||||Kruskal-Wallis|||||||0.3201
72559910|NCT03807440|144650333|OTHER|||||||0.3288|||||||Chi-squared|||||||0.3288
72559911|NCT03807440|144650333|OTHER|||||||0.171|||||||Fisher Exact|||||||0.1710
72559912|NCT03807440|144650334|OTHER|||||||0.013|||||||Kruskal-Wallis|||||||0.0130
72559913|NCT03807440|144650335|OTHER|||||||0.0026|||||||Kruskal-Wallis|||||||0.0026
72559914|NCT03807440|144650336|OTHER|||||||0.3978|||||||Kruskal-Wallis|||||||0.3978
72559915|NCT03807440|144650337|OTHER|||||||0.0055|||||||Chi-squared|||||||0.0055
72469439|NCT04750577|144462631|OTHER|MMRM estimates were used as input for the MCP-Mod. including the fixed, categorical effects of treatment at each visit (baseline, Week 6, Week 12 and Week 20), and the continuous effect of baseline at each visit as well as random effects of patient.||||||0.0659|||||||MCP-Mod Sigmoid emax model fit|Model assumption: 30 % of the maximum effect is achieved at a dose of 3 mg. 90 % of the maximum effect is achieved at a dose of 6 mg.||A flat vs. non-flat dose-response relationship across the 3 doses of BI 685509 and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, exponential, quadratic, Emax and Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.050). The total daily dose was considered for MCP-Mod analysis (placebo, active BI 685509 3 mg, 6 mg, and 9 mg).||||0.0659
72559916|NCT03807440|144650337|OTHER|||||||0.0041|||||||Fisher Exact|||||||0.0041
72559917|NCT03807440|144650338|OTHER||||||<|0.0001|||||||Chi-squared|||||||<.0001
72559918|NCT03807440|144650339|OTHER|||||||0.0399|||||||Chi-squared|||||||0.0399
72559919|NCT03807440|144650339|OTHER|||||||0.0401|||||||Fisher Exact|||||||0.0401
72622370|NCT05524948|144774640|OTHER||Adjusted Mean Difference|-38.04|STANDARD_ERROR_OF_MEAN|26.201||0.1498|TWO_SIDED|95.0|-90.04|13.97|||ANCOVA|Analysis was performed using ANCOVA model with study product and gender as a factor and baseline concentration as a covariate.|For Dimethyl Sulfide|||13.97|-90.04|0.1498
72559920|NCT03807440|144650357|OTHER||||||<|0.0001|||||||Chi-squared|||||||<.0001
72559921|NCT03807440|144650358|OTHER||||||<|0.0001|||||||Chi-squared|||||||<.0001
72559922|NCT03807440|144650359|OTHER|||||||0.0008|||||||Chi-squared|||||||0.0008
72559923|NCT03807440|144650361|OTHER||||||<|0.0001|||||||Chi-squared|||||||<.0001
72559924|NCT03807440|144650362|OTHER|||||||0.0001|||||||Chi-squared|||||||0.0001
72559925|NCT03807440|144650363|OTHER||||||<|0.0001|||||||Chi-squared|||||||<.0001
72559926|NCT03807440|144650364|OTHER||||||<|0.0001|||||||Chi-squared|||||||<.0001
72559927|NCT03807440|144650365|OTHER|||||||0.9184|||||||Chi-squared|||||||0.9184
72559928|NCT03807440|144650365|OTHER|||||||0.9911|||||||Fisher Exact|||||||0.9911
72559929|NCT03807440|144650366|OTHER|||||||0.6967|||||||Chi-squared|||||||0.6967
72559930|NCT03807440|144650366|OTHER|||||||0.6439|||||||Fisher Exact|||||||0.6439
72559931|NCT03807440|144650367|OTHER|||||||0.9414|||||||Chi-squared|||||||0.9414
72559932|NCT03807440|144650367|OTHER|||||||0.8142|||||||Fisher Exact|||||||0.8142
72559933|NCT03807440|144650368|OTHER|||||||0.7837|||||||Chi-squared|||||||0.7837
72559934|NCT03807440|144650368|OTHER|||||||0.7538|||||||Fisher Exact|||||||0.7538
72559935|NCT03807440|144650369|OTHER|||||||0.0012|||||||Chi-squared|||||||0.0012
72559936|NCT03807440|144650370|OTHER||||||<|0.0001|||||||Chi-squared|||||||<.0001
72559937|NCT03807440|144650371|OTHER|||||||0.1906|||||||Chi-squared|||||||0.1906
72559938|NCT03807440|144650372|OTHER|||||||0.6198|||||||Chi-squared|||||||0.6198
72559939|NCT03807440|144650372|OTHER|||||||0.7297|||||||Fisher Exact|||||||0.7297
72559940|NCT03807440|144650374|OTHER||||||<|0.0001|||||||Chi-squared|||||||<.0001
72559941|NCT03807440|144650375|OTHER|||||||0.0012|||||||Chi-squared|||||||0.0012
72559942|NCT03807440|144650375|OTHER|||||||0.0002|||||||Fisher Exact|||||||0.0002
72559943|NCT03807440|144650376|OTHER||||||<|0.0001|||||||Chi-squared|||||||<.0001
72559944|NCT03807440|144650379|OTHER|||||||0.003|||||||Log Rank|||||||0.0030
72559945|NCT01717313|144650386|SUPERIORITY_OR_OTHER||Difference in the least squares means|-0.39|||<|0.001|TWO_SIDED|95.0|-0.59|-0.19|||Constrained Longitudinal Data Analysis|Terms for treatment, time, prior antihyperglycemic agent (AHA) therapy status, interaction of time by treatment, and time by prior AHA therapy status||||-0.19|-0.59|<0.001
72559946|NCT01717313|144650387|SUPERIORITY_OR_OTHER||Differences in percentages vs. placebo|-8.2|||||TWO_SIDED|95.0|-18.8|2.6||||||||2.6|-18.8|
72559947|NCT01717313|144650388|SUPERIORITY_OR_OTHER||Difference in percentages vs. placebo|0.6|||||TWO_SIDED|95.0|-3.1|4.5||||||||4.5|-3.1|
72559948|NCT01717313|144650389|SUPERIORITY_OR_OTHER||Difference in percentages vs. placebo|-5.8|||||TWO_SIDED|95.0|-16.4|4.9||||||||4.9|-16.4|
72559949|NCT01717313|144650390|SUPERIORITY_OR_OTHER||Difference in percentages vs. placebo|0.6|||||TWO_SIDED|95.0|-3.5|4.8||||||||4.8|-3.5|
72559950|NCT01717313|144650391|SUPERIORITY_OR_OTHER||Between-group rate difference|20.3|||<|0.001|TWO_SIDED|95.0|10.5|29.8|||Miettinen & Nurminen method|||||29.8|10.5|<0.001
72559951|NCT01717313|144650392|SUPERIORITY_OR_OTHER||Between-group rate difference|11.4||||0.001|TWO_SIDED|95.0|4.8|18.6|||Miettinen & Nurminen method|||||18.6|4.8|0.001
72559952|NCT01717313|144650393|SUPERIORITY_OR_OTHER||Difference in the least squares means|-10.3||||0.036|TWO_SIDED|95.0|-19.9|-0.7|||Constrained Longitudinal Data Analysis|Terms for treatment, time, prior AHA therapy status, the interaction of time by treatment, and time by prior AHA therapy status||||-0.7|-19.9|0.036
72559953|NCT01717313|144650394|SUPERIORITY_OR_OTHER||Difference in the least squares means|-11.6||||0.177|TWO_SIDED|95.0|-28.6|5.3|||Constrained Longitudinal Data Analysis|Terms for treatment, time, prior AHA therapy status, the interaction of time by treatment, and time by prior AHA therapy status||||5.3|-28.6|0.177
72559954|NCT01717313|144650399|SUPERIORITY_OR_OTHER||Difference in the least squares means|-0.53|||<|0.001|TWO_SIDED|95.0|-0.75|-0.32|||Constrained Longitudinal Data Analysis|Terms for treatment, time, prior AHA therapy status, the interaction of time by treatment, and time by prior AHA therapy status||||-0.32|-0.75|<0.001
72559955|NCT01717313|144650400|SUPERIORITY_OR_OTHER||Difference in the least squares means|-13.2||||0.014|TWO_SIDED|95.0|-23.7|-2.7|||Constrained Longitudinal Data Analysis|Terms for treatment, time, prior AHA therapy status, the interaction of time by treatment, and time by prior AHA therapy status||||-2.7|-23.7|0.014
72559956|NCT01717313|144650401|SUPERIORITY_OR_OTHER||Difference in the least squares means|-20.5||||0.031|TWO_SIDED|95.0|-39.0|-1.9|||Constrained Longitudinal Data Analysis|Terms for treatment, time, prior AHA therapy status, the interaction of time by treatment, and time by prior AHA therapy status||||-1.9|-39.0|0.031
72559957|NCT00835588|144650438|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Geometric Test/Ref Ratio x 100|88.8||||||90.0|82.7|95.4|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||95.4|82.7|
72559958|NCT00835588|144650439|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Geometric Test/Ref Ratio x 100|97.3||||||90.0|93.4|101.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||101|93.4|
72559959|NCT00835588|144650440|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Geometric Test/Ref Ratio x 100|95.6||||||90.0|91.6|99.8|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||99.8|91.6|
72559960|NCT00354159|144650471|SUPERIORITY_OR_OTHER||6-month survival rate|90.5|||<|0.001|ONE_SIDED|97.5|87.7|||The survival estimate at 6-months post-implant was compared to 80%. The comparison was made using the cumulative hazard \[e.g. log survival estimate\] for the variance.|Survival estimate at 6-months|The survival estimate at 6-months post-implant was compared to 80%.||"Null hypothesis: Freedom from Chronicle system-related complications at 6-months post-implant is less than or equal to 80%.~Alternative hypothesis: Freedom from Chronicle system-related complications at 6-months is greater than 80%."|||87.7|<0.001
72559961|NCT00354159|144650473|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.99||||0.978|TWO_SIDED|95.0|0.61|1.61||The P-value is from the Andersen-Gill model, an extension of the Cox proportional hazards model for multiple events.|Andersen-Gill||Hazard Ratio is for the Treatment Arm relative to the Control Arm.|"The study was originally powered at 80% to detect a 25% risk reduction between the treatment arm and control arm with a type I error rate of 0.05. Under these assumptions 648 HF-related events from approximately 1300 subjects were required. The study stopped after 400 were randomized.~Null Hypothesis: The HF-related event rate is the same between the treatment arm and control arm.~Alternative Hypothesis: The HF-related event rate between the treatment arm and control arm is different."||1.61|0.61|0.978
72443225|NCT05450458|144399568|SUPERIORITY|This is a superiority analysis. Data normality was first assessed with the Shapiro-Wilk test, and due to non-normal distributions, a Wilcoxon Signed-Rank Test was applied to compare paired baseline and six-month IKDC score|Baseline to month 6|0.18||||0.001|TWO_SIDED|95.0|0.14|0.21||P-values from pairwise comparisons were adjusted using the Bonferroni method to control for multiple testing. The global p-value from the Friedman test was not adjusted. An a priori threshold for statistical significance was set at p \< 0.05|Wilcoxon Signed-Rank Test|Friedman test conducted with 3 degrees of freedom. Bonferroni correction applied in pairwise Wilcoxon post hoc comparisons.|Median IKDC improvement from baseline to 6 months in 22 athletes with elevated BMI (≥25). No comparator group was used. Confidence interval calculated via bootstrap (resampling with 1,000 iterations).|The analysis was conducted under the null hypothesis of no change in knee function across time. Data normality was assessed using the Shapiro-Wilk test. Changes across the four time points (baseline, 15 days, 3 months, and 6 months) were evaluated using the Friedman test. Pairwise comparisons were performed post hoc using the Wilcoxon Signed-Rank Test with Bonferroni correction at a 5% significance threshold.||0.21|0.14|0.001
72559962|NCT00354159|144650474|SUPERIORITY_OR_OTHER|||||||0.574||95.0|||||Wilcoxon (Mann-Whitney)|||"Null Hypothesis: mu(Treatment) = mu(Control) Alternative Hypothesis: mu(Treatment) ne mu(Control)~where mu is the percentage of hospitalized days for heart failure."||||0.574
72559963|NCT00354159|144650475|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.89||||0.527|TWO_SIDED|95.0|0.62|1.28||The P-value is from the Andersen-Gill model, an extension of the Cox proportional hazards model for multiple events.|Andersen-Gill Model||Hazard Ratio is for the Treatment Arm relative to the Control Arm.|"Null Hypothesis: The CV-related event rate is the same between the treatment arm and control arm.~Alternative Hypothesis: The CV-related event rate between the treatment arm and control arm is different."||1.28|0.62|0.527
72559964|NCT00354159|144650476|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.87||||0.505|TWO_SIDED|95.0|0.57|1.32|||Regression, Cox|The treatment and control hazard ratio and 95% confidence interval was estimated using a univariate cox Regression Model.|Hazard Ratio is for the Treatment Arm relative to the Control Arm|"Null Hypothesis: Freedom from death or HF-related hospitalization is the same between the treatment arm and the control arm.~Alternative Hypothesis: Freedom from death or HF-related hospitalization is different between the treatment arm and the control arm."||1.32|0.57|0.505
72559965|NCT00354159|144650477|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.76||||0.088|TWO_SIDED|95.0|0.56|1.04|||Andersen-Gill Model|The P-value is from the Andersen-Gill model, an extension of the Cox proportional hazards model for multiple events.|Hazard Ratio is for the Treatment Arm relative to the Control Arm.|"Null Hypothesis: The all cause event rate is the same between the treatment arm and control arm.~Alternative Hypothesis: The all cause event rate between the treatment arm and control arm is different."||1.04|0.56|0.088
72559966|NCT00354159|144650478|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.06||||0.758|TWO_SIDED|95.0|0.73|1.54||P-value is from a proportional odds model comparing the distribution of composite endpoint response between the treatment arm and control arm.|Proportional odds model||Odds ratio represents the odds of improved score in the treatment group relative to the control group.|"Null Hypothesis: Distribution of composite response endpoint is the same between the treatment arm and the control arm.~Alternative Hypothesis: Distribution of composite response endpoint is different between the treatment arm and the control arm."||1.54|0.73|0.758
72619150|NCT01550965|144769021|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-25.33|||<|0.001|TWO_SIDED|95.0|-29.97|-20.7|||Paired t-test, 2 sided|||Statistical analysis for mean change in WPAI-SHP: overall work impairment percentage from week 0 to week 18. Efficacy assessments were not specified at week 18; missing data at week 18 were imputed using LOCF.||-20.70|-29.97|<0.001
72619151|NCT01550965|144769021|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-29.22|||<|0.001|TWO_SIDED|95.0|-33.5|-24.93|||Paired t-test, 2 sided|||Statistical analysis for mean change in WPAI-SHP: overall work impairment percentage from week 0 to week 26.||-24.93|-33.50|<0.001
72496755|NCT00428597|144522967|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.23||||0.1339|TWO_SIDED|95.0|-1.6|12.1||From repeated measures mixed-effects with intercept term, treatment, time from first dose, treatment-by-time interaction and baseline score (intercept and time from dose as random effects). No p-value adjustments were made for multiple comparisons.|Repeated Measures Mixed-Effects Model||Estimated mean difference with 95% CI and p-value were obtained from the repeated measures mixed-effects model using data from Cycle 2 through Cycle 10.|Cycle 2 through Cycle 10||12.1|-1.6|0.1339
72496756|NCT00428597|144522968|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.7816||||0.6138|TWO_SIDED|95.0|-5.1|8.7||From repeated measures mixed-effects with intercept term, treatment, time from first dose, treatment-by-time interaction and baseline score (intercept and time from dose as random effects). No p-value adjustments were made for multiple comparisons.|Repeated Measures Mixed-Effects Model||Estimated mean difference with 95% CI and p-value were obtained from the repeated measures mixed-effects model using data from Cycle 2 through Cycle 10.|Cycle 2 through Cycle 10||8.7|-5.1|0.6138
72496757|NCT00428597|144522969|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2778||||0.9367|TWO_SIDED|95.0|-6.6|7.1||From repeated measures mixed-effects with intercept term, treatment, time from first dose, treatment-by-time interaction and baseline score (intercept and time from dose as random effects). No p-value adjustments were made for multiple comparisons.|Repeated Measures Mixed-Effects Model||Estimated mean difference with 95% CI and p-value were obtained from the repeated measures mixed-effects model using data from Cycle 2 through Cycle 10.|Cycle 2 through Cycle 10||7.1|-6.6|0.9367
72496758|NCT00428597|144522970|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.753||||0.0372|TWO_SIDED|95.0|0.5|15.0||From repeated measures mixed-effects with intercept term, treatment, time from first dose, treatment-by-time interaction and baseline score (intercept and time from dose as random effects). No p-value adjustments were made for multiple comparisons.|Repeated Measures Mixed-Effects Model||Estimated mean difference with 95% CI and p-value were obtained from the repeated measures mixed-effects model using data from Cycle 2 through Cycle 10.|Cycle 2 through Cycle 10||15|0.5|0.0372
72496759|NCT00428597|144522971|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.1463||||0.6939|TWO_SIDED|95.0|-4.6|6.9||From repeated measures mixed-effects with intercept term, treatment, time from first dose, treatment-by-time interaction and baseline score (intercept and time from dose as random effects). No p-value adjustments were made for multiple comparisons.|Repeated Measures Mixed-Effects Model||Estimated mean difference with 95% CI and p-value were obtained from the repeated measures mixed-effects model using data from Cycle 2 through Cycle 10.|Cycle 2 through Cycle 10||6.9|-4.6|0.6939
72559967|NCT00354159|144650481|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.77||||0.599|TWO_SIDED|95.0|0.29|2.06|||Regression, Cox|The treatment to control hazard ratio and 95% confidence interval was estimated using a univariate Cox Regression Model|Hazard ratio estimates the hazard of death in the treatment group relative to the control group.|"Null hypothesis: Survival during the 12-month randomized follow-up period is the same between the treatment and control groups.~Alternative hypothesis: Survival during the 12-month randomized period is different between the treatment and control groups."||2.06|0.29|0.599
72559968|NCT00354159|144650482|SUPERIORITY_OR_OTHER|||||||0.145||95.0|||||Negative-Binomial Regression|||The null hypothesis is that the rate of cardiovascular medication changes is the same between the Treatment Arm and Control Arm.||||0.145
72559969|NCT00354159|144650483|SUPERIORITY_OR_OTHER|||||||0.033||95.0|||||t-test, 2 sided|||"Null hypothesis: Average daily median ePAD is the same between the Treatment and Control arms.~Alternative hypothesis: Average daily median ePAD is the different between the Treatment and Control arms."||||0.033
72619152|NCT01550965|144769022|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-18.16|||<|0.001|TWO_SIDED|95.0|-20.47|-15.85|||Paired t-test, 2 sided|||Statistical analysis for mean change in WPAI-SHP: percentage of activity impairment from week 0 to week 2.||-15.85|-20.47|<0.001
72496760|NCT00428597|144522972|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.5128||||0.3711|TWO_SIDED|95.0|-11.2|4.2||From repeated measures mixed-effects with intercept term, treatment, time from first dose, treatment-by-time interaction and baseline score (intercept and time from dose as random effects). No p-value adjustments were made for multiple comparisons.|Repeated Measures Mixed-Effects Model||Estimated mean difference with 95% CI and p-value were obtained from the repeated measures mixed-effects model using data from Cycle 2 through Cycle 10.|Cycle 2 through Cycle 10||4.2|-11.2|0.3711
72496761|NCT00954109|144523001|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||t-test, 1 sided|||||||<0.05
72496762|NCT00954109|144523002|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||t-test, 1 sided|||||||<0.05
72496763|NCT01445678|144523010|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was concluded if the lower bound of the 2-sided 95% confidence interval was greater than -10%.|Risk Difference (RD)|-4.2|||||TWO_SIDED|95.0|-8.91|0.54||||||||0.54|-8.91|
72496764|NCT01445678|144523011|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was concluded if the lower bound of the 2-sided 95% confidence interval was greater than -10%.|Risk Difference (RD)|-1.0|||||TWO_SIDED|95.0|-4.52|2.59||||||||2.59|-4.52|
72496765|NCT01445678|144523012|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-3.1|||||TWO_SIDED|95.0|-7.23|0.89||||||||0.89|-7.23|
72496766|NCT01445678|144523013|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.4|||||TWO_SIDED|95.0|-3.4|2.33||||||||2.33|-3.4|
72496767|NCT01445678|144523014|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-4.1|||||TWO_SIDED|95.0|-9.09|0.94||||||||0.94|-9.09|
72496768|NCT01445678|144523015|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.7|||||TWO_SIDED|95.0|-0.88|2.37||||||||2.37|-0.88|
72496769|NCT05523973|144523028|SUPERIORITY|||||||0.66|||||||Wilcoxon (Mann-Whitney)|||||||0.66
72559970|NCT00354159|144650484|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||t-test, 2 sided|||"Null Hypothesis: The average daily median ePAD is not different among Control Arm subjects that have and that do not have a heart failure related event during the 12-month follow-up period.~Alternative Hypothesis: The average daily median ePAD is different among Control Arm subjects that have and that do not have a heart failure related event during the 12-month follow-up period."||||0.002
72559971|NCT00354159|144650485|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.27||||0.292|TWO_SIDED|95.0|0.82|1.96|||Proportional odds regression model||Direction for odds ratio is the odds of improvement in the Treatment arm versus the odds of improvement in the Control arm.|"Null Hypothesis: There is no difference in the change in NYHA functional class between the Treatment and Control Arms.~Alternative Hypothesis: There is a difference in the change in NYHA functional class between the Treatment and Control Arms."||1.96|0.82|0.292
72496770|NCT05523973|144523029|SUPERIORITY|||||||1|||||||Chi-squared|||||||1.0
72496771|NCT05523973|144523030|SUPERIORITY|||||||0.09|||||||Sign test|||||||0.09
72496772|NCT05523973|144523031|SUPERIORITY|||||||0.722|||||||Sign test|||||||.722
72496773|NCT05523973|144523032|SUPERIORITY|||||||0.28|||||||Sign test|||||||.28
72496774|NCT05523973|144523033|SUPERIORITY|||||||0.15|||||||Sign test|||||||.15
72559972|NCT00354159|144650486|SUPERIORITY_OR_OTHER|||||||0.996||95.0|||||Mixed Models Analysis|||"Null Hypothesis: The change in 6-minute hall walk distance is not different between the Treatment and Control Arms.~Alternative Hypothesis: The change in 6-minute hall walk distance is different between the Treatment and Control Arms."||||0.996
72559973|NCT00354159|144650487|SUPERIORITY_OR_OTHER|||||||0.154||95.0|||||Mixed Models Analysis|||"Null Hypothesis: The change from baseline to the 12-month follow-up visit in eGFR values is the same between the Treatment arm and Control arm.~Alternative Hypothesis: The change from baseline to the 12-month follow-up visit in eGFR values is different between the Treatment arm and Control arm."||||0.154
72559974|NCT00354159|144650490|SUPERIORITY_OR_OTHER|||||||0.583||95.0|||||Mixed Models Analysis|Response was change in MNLWHF score from baseline. Model adjusted for baseline MNLWHF score. Negative changes mean an improvement in MNLWHF score.||"Null Hypothesis: There is no difference in the change in MNLWHF score from baseline to 12-months between the Treatment Arm and Control Arm.~Alternative Hypothesis: There is a difference in the change in MNLWHF score from baseline to 12-months between the Treatment Arm and Control Arm."||||0.583
72496775|NCT05523973|144523034|SUPERIORITY|||||||0.8|||||||Sign test|||||||.8
72496776|NCT05523973|144523035|SUPERIORITY|||||||0.12|||||||t-test, 2 sided|||||||.12
72496777|NCT05523973|144523036|SUPERIORITY|||||||0.92|||||||Sign test|||||||.92
72496778|NCT03521791|144523054|NON_INFERIORITY|it is considered not inferior if the differences between the groups do not exceed 20%.||||||0.133|||||||Chi-squared, Corrected|||||||0.133
72496779|NCT03521791|144523055|NON_INFERIORITY|it is considered not inferior if the differences between the groups do not exceed 20%.||||||0.045|||||||Wilcoxon (Mann-Whitney)|||||||0.045
72496780|NCT03521791|144523056|NON_INFERIORITY|it is considered not inferior if the differences between the groups do not exceed 20%.||||||0.333|||||||Chi-squared, Corrected|||||||0.333
72496781|NCT03521791|144523057|NON_INFERIORITY|it is considered not inferior if the differences between the groups do not exceed 20%.||||||0.058|||||||Wilcoxon (Mann-Whitney)|||||||0.058
72496782|NCT03521791|144523058|NON_INFERIORITY|it is considered not inferior if the differences between the groups do not exceed 20%.||||||0.394|||||||Fisher Exact|||||||0.394
72496783|NCT03521791|144523059|NON_INFERIORITY|it is considered not inferior if the differences between the groups do not exceed 20%.||||||0.056|||||||t-test, 2 sided|||||||0.056
72496784|NCT03521791|144523061|NON_INFERIORITY|it is considered not inferior if the differences between the groups do not exceed 20%.||||||0.114|||||||Fisher Exact|||||||0.114
72496785|NCT03521791|144523062|NON_INFERIORITY|it is considered not inferior if the differences between the groups do not exceed 20%.||||||0.117|||||||Chi-squared, Corrected|||||||0.117
72496786|NCT03521791|144523063|NON_INFERIORITY|it is considered not inferior if the differences between the groups do not exceed 20%.||||||0.626|||||||Fisher Exact|||||||0.626
72496787|NCT04024501|144523068|OTHER||Geometric Mean ratio|106.2|||||TWO_SIDED|90.0|91.73|122.96|||Mixed Model Analysis|The number of subjects in this analysis: 22||Pairwise comparison: Treatment 2/Treatment 1||122.96|91.73|
72496788|NCT04024501|144523068|OTHER||Geometric mean ratio|50.02|||||TWO_SIDED|90.0|42.34|59.1|||Mixed Model Analysis|The number of subjects in this analysis: 22||Pairwise comparison: Treatment 3/Treatment 1||59.10|42.34|
72496789|NCT04024501|144523068|OTHER||Geometric mean ratio|47.1|||||TWO_SIDED|90.0|39.85|55.68|||Mixed Model Analysis|The number of subjects in this analysis: 15||Pairwise comparison: Treatment 3/Treatment 2||55.68|39.85|
72496790|NCT04024501|144523068|OTHER||Geometric mean ratio|58.4|||||TWO_SIDED|90.0|49.49|68.92|||Mixed Model Analysis|The number of subjects in this analysis: 15||Pairwise comparison: Treatment 3/Treatment 4||68.92|49.49|
72496791|NCT04024501|144523068|OTHER||Geometric mean ratio|85.65|||||TWO_SIDED|90.0|73.78|99.43|||Mixed Model Analysis|The number of subjects in this analysis: 21||Pairwise comparison: Treatment 4/Treatment 1||99.43|73.78|
72496792|NCT04024501|144523068|OTHER||Geometric mean ratio|80.65|||||TWO_SIDED|90.0|69.48|93.62|||Mixed Model Analysis|The number of subjects in this analysis: 21||Pairwise comparison: Treatment 4/Treatment 2||93.62|69.48|
72496793|NCT04024501|144523068|OTHER||Geometric mean ratio|89.88|||||TWO_SIDED|90.0|77.61|104.09|||Mixed Model Analysis|The number of subjects in this analysis: 21||Pairwise comparison: Treatment 5/Treatment 1||104.09|77.61|
72496794|NCT04024501|144523068|OTHER||Geometric mean ratio|84.64|||||TWO_SIDED|90.0|72.94|98.2|||Mixed Model Analysis|The number of subjects in this analysis: 21||Pairwise comparison: Treatment 5/Treatment 2||98.20|72.94|
72496795|NCT04024501|144523068|OTHER||Geometric mean ratio|179.68|||||TWO_SIDED|90.0|151.57|212.99|||Mixed Model Analysis|The number of subjects in this analysis: 21||Pairwise comparison: Treatment 5/Treatment 3||212.99|151.57|
72496796|NCT04024501|144523068|OTHER||Geometric mean ratio|104.94|||||TWO_SIDED|90.0|90.18|122.11|||Mixed Model Analysis|The number of subjects in this analysis: 21||Pairwise comparison: Treatment 5/Treatment 4||122.11|90.18|
72496797|NCT04024501|144523069|OTHER||Geometric mean ratio|100.39|||||TWO_SIDED|90.0|84.94|118.65|||Mixed Model Analysis|The number of subjects in this analysis: 25||Pairwise comparison: Treatment 2/Treatment 1||118.65|84.94|
72496798|NCT04024501|144523069|OTHER||Geometric mean ratio|41.26|||||TWO_SIDED|90.0|34.74|49.0|||Mixed Model Analysis|The number of subjects in this analysis: 23||Pairwise comparison: Treatment 3/Treatment 1||49.00|34.74|
72559975|NCT00354159|144650491|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.48||||0.368|TWO_SIDED|95.0|0.63|3.5||The P-value is from the Andersen-Gill model which adjusts for multiple VT/VF episodes per subject.|Andersen-Gill Model|Andersen-Gill model included a term for Treatment Arm. This model adjusts for multiple events per subject.||"Null Hypothesis: Rate of VT/VF episodes during the 12-month randomized period is the same between the Treatment Arm and the Control Arm.~Alternative Hypothesis: Rate of VT/VF episodes during the 12-month randomized period is different between the Treatment Arm and the Control Arm."||3.5|0.63|0.368
72619153|NCT01550965|144769022|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-25.43|||<|0.001|TWO_SIDED|95.0|-28.3|-22.56|||Paired t-test, 2 sided|||Statistical analysis for mean change in WPAI-SHP: percentage of activity impairment from week 0 to week 8.||-22.56|-28.30|<0.001
72559976|NCT01196390|144650527|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.85|TWO_SIDED|95.0|0.69|1.36|||Log Rank|Two-sided significance level = 0.05|Reference level = Chemoradiation arm|Assuming a median DFS time of 15 months (Arm 2), hypothesized increase in DFS corresponding to median DFS time of 25 months (Arm 1). Assuming an exponential distribution and constant hazards, 183 HER2-positive participants accrued over 5 years and followed for 3 years would result in 162 disease-free survival events and provide 90% statistical power to detect this difference with a 2-sided α of 0.05 and 2 interim analyses. See Limitations and Caveats section.||1.36|0.69|0.85
72559977|NCT01196390|144650528|SUPERIORITY|||||||0.71|||||||Chi-squared|Two-sided significance level = 0.05||||||0.71
72559978|NCT01196390|144650529|SUPERIORITY||Hazard Ratio (HR)|1.01||||0.95|TWO_SIDED|95.0|0.69|1.47|||Log Rank|Two-sided significance level = 0.05|Reference level = Chemoradiation arm|||1.47|0.69|0.95
72559979|NCT01196390|144650531|SUPERIORITY|||||||0.39||||||One-side significance level = 0.05|Chi-squared|||6-8 weeks||||0.39
72559980|NCT01196390|144650531|SUPERIORITY|||||||0.78||||||One-side significance level = 0.05|Chi-squared|||1 year||||0.78
72559981|NCT01196390|144650531|SUPERIORITY|||||||0.28||||||One-side significance level = 0.05|Chi-squared|||2 years||||0.28
72559982|NCT01196390|144650534|SUPERIORITY||Odds Ratio (OR)|2.35||||0.021|TWO_SIDED|95.0|1.13|4.86|||Regression, Logistic|||Logistic regression was used to model the association of treatment arm (Arm 1 vs. 2 \[reference level(RL)\]), T stage (T3 vs.T1,T2 \[RL\]), Zubrod (1,2 vs. 0 \[RL\]), gender (male vs. female \[RL\]), presence of adenopathy (yes vs. no \[RL\]), and age (≥ 60 vs. \<60 \[RL\]) with the occurrence of any cardiac AE, using backwards step-wise model selection requiring p≤0.05 for a covariate to remain in the model. Final model covariates are reported. Age is reported here. No other covariates reported.||4.86|1.13|0.021
72559983|NCT01949532|144650541|SUPERIORITY_OR_OTHER||Ratio of geometric means|132.75|||||TWO_SIDED|90.0|70.6|249.63|||||The point estimates of the geometric mean ratios for the PK parameters were calculated by exponentiation of the differences in the least-squares means between the renal impairment group (test) and participants with normal renal function (reference).|||249.63|70.60|
72559984|NCT01949532|144650542|SUPERIORITY_OR_OTHER||Ratio of geometric means|133.62|||||TWO_SIDED|90.0|70.93|251.73||||||||251.73|70.93|
72559985|NCT04387617|144650578|SUPERIORITY||Mean Difference (Final Values)|0.4|STANDARD_DEVIATION|2.6||0.5|TWO_SIDED|95.0|-0.8|1.6|||t-test, 2 sided|||||1.6|-0.8|0.5
72559986|NCT02413008|144650582|OTHER|The primary endpoint, the variation of FSH between week 12 and baseline and also comparing by arm will be analyzed using a non-parametric test (Mann-Whitney-Wilcoxon test).||||||0.1|||||||Wilcoxon (Mann-Whitney)|||"The variations of the levels of FSH after treatment was studied in each women at baseline, week 3 and week12 weeks, the variation of levels between two arms were analysed using a non-parametric test Mann-Whitney-Wilcoxon.~The intra individual variation (differences between the pre study determinations screening and baseline) was compared to the variation between baseline and the values obtained at every study visit."||||0.10
72559987|NCT02413008|144650582|OTHER|The primary endpoint, the variation of FSH between week 12 and baseline and also comparing by arm will be analyzed using a non-parametric test (Mann-Whitney-Wilcoxon test).||||||0.413|||||||Wilcoxon (Mann-Whitney)|||The variations in the intensities for each one of the symptoms and signs of the vaginal atrophy, after 3 and 12 weeks, in each treatment arm, will be compared using the non-parametric test Mann-Whitney-Wilcoxon.||||0.413
72559988|NCT02413008|144650582|OTHER|||||||0.15|||||||Wilcoxon (Mann-Whitney)|||||||0.15
72559989|NCT02413008|144650583|OTHER||||||<|0.05|||||||Dunn Test|||Variation in serum levels of FSH at week 1||||<0.05
72559990|NCT02413008|144650583|OTHER||||||<|0.05|||||||Dunn Test|||Variation in serum levels of FSH at week 3||||<0.05
72559991|NCT02413008|144650583|OTHER||||||>|0.05|||||||Dunn Test|||Variation in serum levels of FSH at week 8||||>0.05
72559992|NCT02413008|144650584|OTHER||||||>|0.05|||||||Dunn Test|||Change in serum levels of Luteinizing hormone (LH) from baseline to week 1||||>0.05
72559993|NCT02413008|144650584|OTHER||||||>|0.05|||||||Dunn Test|||Change in serum levels of Luteinizing hormone (LH) from baseline to week 3||||>0.05
72559994|NCT02413008|144650584|OTHER||||||>|0.05|||||||Dunn Test|||Change in serum levels of Luteinizing hormone (LH) from baseline to week 8||||>0.05
72559995|NCT02413008|144650584|OTHER|||||||0.135|||||||Wilcoxon (Mann-Whitney)|||Change in serum levels of Luteinizing hormone (LH) from baseline to week 12||||0.135
72559996|NCT02413008|144650585|OTHER|||||||0.043|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to week 1 in plasma levels of estriol||||0.043
72559997|NCT02413008|144650585|OTHER|||||||0.649|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to week 3 in plasma levels of estriol||||0.649
72559998|NCT02413008|144650585|OTHER|||||||0.588|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to week 8 in plasma levels of estriol||||0.588
72559999|NCT02413008|144650585|OTHER|||||||0.67|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to week 12 in plasma levels of estriol||||0.67
72560000|NCT02413008|144650586|OTHER|||||||0.342|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to week 1 in plasma levels of estradiol.||||0.342
72560001|NCT02413008|144650586|OTHER|||||||0.523|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to week 3 in plasma levels of estradiol.||||0.523
72560002|NCT02413008|144650586|OTHER|||||||0.523|||||||Wilcoxon (Mann-Whitney)|||Change in plasma levels of estradiol from baseline to week 8||||0.523
72560003|NCT02413008|144650586|OTHER|||||||0.163|||||||Wilcoxon (Mann-Whitney)|||Change in plasma levels of estradiol from baseline to week 12||||0.163
72560004|NCT02413008|144650587|OTHER|||||||0.418|||||||Wilcoxon (Mann-Whitney)|||Change in plasma levels of estrona from baseline to week 1||||0.418
72560005|NCT02413008|144650587|OTHER|||||||0.642|||||||Wilcoxon (Mann-Whitney)|||Change in plasma levels of estrona from baseline to week 3||||0.642
72560006|NCT02413008|144650587|OTHER|||||||0.175|||||||Wilcoxon (Mann-Whitney)|||Change in plasma levels of estrona from baseline to week 8||||0.175
72560007|NCT02413008|144650587|OTHER|||||||0.084|||||||Wilcoxon (Mann-Whitney)|||Change in plasma levels of estrona from baseline to week 12||||0.084
72560008|NCT02413008|144650588|OTHER||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||Change in pH between baseline and week 3||||<0.01
72560009|NCT02413008|144650588|OTHER|||||||0.057|||||||Wilcoxon (Mann-Whitney)|||Change in pH between baseline and week 12||||0.057
72560010|NCT02413008|144650589|OTHER|||||||0.14|||||||Wilcoxon (Mann-Whitney)|||Changes in dyspareunia from baseline to week 3||||0.14
72560011|NCT02413008|144650589|OTHER|||||||0.25|||||||Wilcoxon (Mann-Whitney)|||Changes in dyspareunia from baseline to week 12||||0.25
72560012|NCT02413008|144650590|OTHER|||||||0.28|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to week 3||||0.28
72560013|NCT02413008|144650590|OTHER|||||||0.34|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to week 12||||0.34
72560014|NCT02413008|144650591|OTHER|||||||0.14|||||||Wilcoxon (Mann-Whitney)|||Changes in vaginal dryness from baseline to week 3||||0.14
72560015|NCT02413008|144650591|OTHER||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||Changes in vaginal dryness from baseline to week 12||||<0.01
72560016|NCT02413008|144650592|OTHER|||||||0.03|||||||Wilcoxon (Mann-Whitney)|||Changes in total score of symptoms of vaginal atrophy from baseline to week 3||||0.03
72443226|NCT05450458|144399568|SUPERIORITY|This is a superiority analysis. Data normality was first assessed with the Shapiro-Wilk test, and due to non-normal distributions, a Wilcoxon Signed-Rank Test was applied to compare paired baseline and six-month KOOS score|Baseline to Month 6|18.5|||<|0.001|TWO_SIDED|95.0|13.0|22.0||The p-values reported were not adjusted for multiple comparisons, and the a priori threshold for statistical significance was set at p \< 0.05|Wilcoxon Signed-Rank Test|Friedman test conducted with 3 degrees of freedom. Bonferroni correction applied in pairwise Wilcoxon post hoc comparisons.|Median KOOS improvement from baseline to 6 months in 22 athletes with elevated BMI. CI calculated via bootstrap resampling (1,000 iterations). No comparator group was involved.|The analysis was conducted under the null hypothesis of no change in knee function between baseline and six months. The study was designed with sufficient power to detect clinically meaningful improvements, with significance determined at a conventional level||22|13|<0.001
72443227|NCT02794480|144399569|SUPERIORITY||||||<|0.001||||||ELLIPTA versus GSK MDI|Mainland-Gart test||||Mainland-Gart test is favorable over the McNemar test for matched pairs as the latter is only valid in case of no period effects.|||<0.001
72443228|NCT02794480|144399569|SUPERIORITY|||||||0.007||||||ELLIPTA versus AZ MDI|Mainland-Gart test||||Mainland-Gart test is favorable over the McNemar test for matched pairs as the latter is only valid in case of no period effects.|||0.007
72443229|NCT02794480|144399574|SUPERIORITY||Odds Ratio (OR)|5.94|||<|0.001|TWO_SIDED|95.0|2.42||The upper limit is infinity.|Exact odds ratio calculated using exact conditional logistic regression adjusted for treatment and treatment period.|Conditional Logistic Regression||ELLIPTA versus GSK MDI||||2.42|<0.001
72443230|NCT02794480|144399574|SUPERIORITY||Odds Ratio (OR)|4.16||||0.011|TWO_SIDED|95.0|1.59||The upper limit is infinity.|Exact odds ratio calculated using exact conditional logistic regression adjusted for treatment and treatment period.|Conditional Logistic Regression||ELLIPTA versus AZ MDI||||1.59|0.011
72560017|NCT02413008|144650592|OTHER|||||||0.04|||||||Wilcoxon (Mann-Whitney)|||Changes in total score of symptoms of vaginal atrophy from baseline to week 12||||0.04
72560018|NCT02413008|144650593|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Changes in dryness of the mucosa between baseline and week 3||||<0.001
72619154|NCT01550965|144769022|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-24.42|||<|0.001|TWO_SIDED|95.0|-27.33|-21.5|||Paired t-test, 2 sided|||Statistical analysis for mean change in WPAI-SHP: percentage of activity impairment from week 0 to week 18. Efficacy assessments were not specified at week 18; missing data at week 18 were imputed using last observation carried forward (LOCF).||-21.50|-27.33|<0.001
72443231|NCT00262301|144399575|SUPERIORITY_OR_OTHER|||||||0.003||95.0|||||Log Rank|||||||0.003
72560019|NCT02413008|144650593|OTHER||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||Changes in dryness of the mucosa betweeen baseline and week 12||||<0.01
72560020|NCT02413008|144650594|OTHER|||||||0.13|||||||Wilcoxon (Mann-Whitney)|||Changes in dryness of the mucosa between baseline and week 3||||0.13
72560021|NCT02413008|144650594|OTHER||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||Changes in dryness of the mucosa between baseline and week 12||||<0.01
72560022|NCT02413008|144650595|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to week 3||||<0.001
72560023|NCT02413008|144650595|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to week 12||||<0.001
72560024|NCT02413008|144650596|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Change in total score of signs between week 3 and baseline||||<0.001
72560025|NCT02413008|144650596|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Change in total score of signs between week 12 and baseline||||<0.001
72560026|NCT02413008|144650597|OTHER||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||Change in maturation value from baseline to week 3||||<0.0001
72560027|NCT02413008|144650597|OTHER|||||||0.006|||||||Wilcoxon (Mann-Whitney)|||Change in maturation value from baseline to week 12||||0.006
72560028|NCT01139762|144650640|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.41||||0.001|TWO_SIDED|95.0|-2.27|-0.55|||Mixed Model Repeated Measures Analysis|The Kenward-Roger approximation was used to estimate denominator degrees of freedom.||MMRM model includes treatment, region, visit, and treatment-by-visit interaction as fixed effects, and subject as a random effect. Baseline total IPSS was the covariate. No imputation of missing total IPSS data was performed. The within-subject errors were modeled using an unstructured covariance structure.||-0.55|-2.27|0.001
72560029|NCT01139762|144650642|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.51||||0.007|TWO_SIDED|95.0|-0.87|-0.14||P-value is for IPSS storage (irritative) subscore - 4 weeks.|Mixed Model Repeated Measures Analysis|The Kenward-Roger approximation was used to estimate denominator degrees of freedom.||MMRM model includes treatment, region, visit, and treatment-by-visit interaction as fixed effects, and subject as a random effect. Baseline total IPSS was the covariate. No imputation of missing total IPSS data was performed. The within-subject errors were modeled using an unstructured covariance structure.||-0.14|-0.87|0.007
72560030|NCT01139762|144650642|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.41||||0.04|TWO_SIDED|95.0|-0.8|-0.02||P-value is for IPSS storage (irritative) subscore - 12 weeks.|Mixed Model Repeated Measures Analysis|The Kenward-Roger approximation was used to estimate denominator degrees of freedom.||MMRM model includes treatment, region, visit, and treatment-by-visit interaction as fixed effects, and subject as a random effect. Baseline total IPSS was the covariate. No imputation of missing total IPSS data was performed. The within-subject errors were modeled using an unstructured covariance structure.||-0.02|-0.80|0.040
72560031|NCT01139762|144650642|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.34||||0.107|TWO_SIDED|95.0|-0.75|0.07||P-value is for IPSS storage (irritative) subscore - 26 weeks|Mixed Model Repeated Measures Analysis|The Kenward-Roger approximation was used to estimate denominator degrees of freedom.||MMRM model includes treatment, region, visit, and treatment-by-visit interaction as fixed effects, and subject as a random effect. Baseline total IPSS was the covariate. No imputation of missing total IPSS data was performed. The within-subject errors were modeled using an unstructured covariance structure.||0.07|-0.75|0.107
72560032|NCT01139762|144650642|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.18|||<|0.001|TWO_SIDED|95.0|-1.69|-0.68||P-value is for IPSS voiding (obstructive) subscore - 4 weeks.|Mixed Model Repeated Measures Analysis|The Kenward-Roger approximation was used to estimate denominator degrees of freedom.||MMRM model includes treatment, region, visit, and treatment-by-visit interaction as fixed effects, and subject as a random effect. Baseline total IPSS was the covariate. No imputation of missing total IPSS data was performed. The within-subject errors were modeled using an unstructured covariance structure.||-0.68|-1.69|<0.001
72443232|NCT00262301|144399576|SUPERIORITY_OR_OTHER|||||||0.005||95.0|||||Log Rank|||||||0.005
72443233|NCT01017146|144399577|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The p-value indicates treatment differences between tazarotene foam and vehicle foam for ILs|ANCOVA|||||||<0.001
72443234|NCT01017146|144399577|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The p-value indicates treatment differences between tazarotene foam and vehicle foam for NILs|ANCOVA|||||||<0.001
72443235|NCT01017146|144399577|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The p-value indicates treatment differences between tazarotene foam and vehicle foam for TLs|ANCOVA|||||||<0.001
72443236|NCT01017146|144399578|SUPERIORITY_OR_OTHER||Percentage of participants|35.6|||<|0.001|TWO_SIDED|95.0|30.7|40.5|||Cochran-Mantel-Haenszel||The estimated value represents the percentage of participants receiving tazarotene foam with a minimum 2 G improvement in the ISGA score from Baseline at Week 12.|||40.5|30.7|<0.001
72443237|NCT01017146|144399578|SUPERIORITY_OR_OTHER||Percentage of participants|23.9|||||TWO_SIDED|95.0|19.6|28.3|||||The estimated value represents the percentage of participants receiving vehicle foam with a minimum 2 G improvement in the ISGA score from Baseline at Week 12.|||28.3|19.6|
72443238|NCT01017146|144399579|SUPERIORITY_OR_OTHER||Percentage of participants|28.8|||<|0.001|TWO_SIDED|95.0|24.2|33.5|||Cochran-Mantel-Haenszel||The estimated value represents the percentage of participants receiving tazarotene foam with an ISGA score of 0 or 1 at Week 12.|||33.5|24.2|<0.001
72443239|NCT01017146|144399579|SUPERIORITY_OR_OTHER||Percentage of participants|16.1|||||TWO_SIDED|95.0|12.4|19.9|||||The estimated value represents the percentage of participants receiving vehicle foam with an ISGA score of 0 or 1 at Week 12.|||19.9|12.4|
72443240|NCT01172418|144399603|SUPERIORITY|||||||0.78|||||||Log Rank|||||||0.78
72443241|NCT01172418|144399604|SUPERIORITY|||||||0.37|||||||Log Rank|||||||0.37
72443242|NCT01172418|144399605|SUPERIORITY|||||||0.99|||||||Log Rank|||||||0.99
72443243|NCT01172418|144399606|SUPERIORITY|||||||0.25|||||||Log Rank|||||||0.25
72443244|NCT00976937|144399716|SUPERIORITY_OR_OTHER||Response rate difference|4.6|STANDARD_ERROR_OF_MEAN|3.28||0.1696|TWO_SIDED|95.0|-1.84|11.0||Cochran-Mantel-Haenszel (CMH) test stratified by randomization strata of screening HbA1c (\<8.0 or \>=8.0%) and randomization strata of screening BMI (\<35 or \>=35 kg/m\^2) was used.|Cochran-Mantel-Haenszel|||To demonstrate the superiority of lixisenatide over sitagliptin, 150 patients in each arm would provide a power of 90% with a 2-sided test at the 5% significance level, assuming the percentage of patients defined as responders on HbA1c (\<7%) and weight (at least 5% loss) is 25% with lixisenatide and 10% with sitagliptin.||11.00|-1.84|0.1696
72496799|NCT04024501|144523069|OTHER||Geometric mean ratio|41.1|||||TWO_SIDED|90.0|34.61|48.81|||Mixed Model Analysis|The number of subjects in this analysis: 23||Pairwise comparison: Treatment 3/Treatment 2||48.81|34.61|
72619155|NCT01550965|144769022|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-27.22|||<|0.001|TWO_SIDED|95.0|-30.28|-24.16|||Paired t-test, 2 sided|||Statistical analysis for mean change in WPAI-SHP: percentage of activity impairment from week 0 to week 26.||-24.16|-30.28|<0.001
72619156|NCT03760640|144769023|SUPERIORITY||LS Mean Difference|-0.86||||0.339|TWO_SIDED|90.0|-2.35|0.63|||Mixed Models Analysis|||||0.63|-2.35|0.339
72443245|NCT01227265|144399765|SUPERIORITY_OR_OTHER||Difference in Estimated Means|-0.2||||0.4933|TWO_SIDED|95.0|-0.72|0.35|||cLDA|||||0.35|-0.72|0.4933
72443246|NCT01227265|144399765|SUPERIORITY_OR_OTHER||Difference in Estimated Means|-0.3||||0.2364|TWO_SIDED|95.0|-0.86|0.21|||cLDA|||||0.21|-0.86|0.2364
72443247|NCT01227265|144399766|SUPERIORITY_OR_OTHER||Estimated Difference in Percentage|7.0||||0.244|TWO_SIDED|95.0|-4.17|18.05||p-value is for the estimated Odds Ratio based on a generalized linear mixed model with baseline average OFF time (hours/day) as a covariate and treatment-by-time interaction as fixed effect and participant as random effect.|Mixed Models Analysis|||||18.05|-4.17|0.244
72443248|NCT01227265|144399766|SUPERIORITY_OR_OTHER||Estimated Difference in Percentage|6.5||||0.262|TWO_SIDED|95.0|-4.63|17.61||p-value is for the estimated Odds Ratio based on a generalized linear mixed model with baseline average OFF time (hours/day) as a covariate and treatment-by-time interaction as fixed effect and participant as random effect.|Mixed Models Analysis|||||17.61|-4.63|0.262
72443249|NCT01227265|144399767|SUPERIORITY_OR_OTHER||Difference in Estimated Means|0.1||||0.776|TWO_SIDED|95.0|-0.47|0.63|||cLDA|||||0.63|-0.47|0.776
72443250|NCT01227265|144399767|SUPERIORITY_OR_OTHER||Difference in Estimated Means|0.1||||0.683|TWO_SIDED|95.0|-0.44|0.67|||cLDA|||||0.67|-0.44|0.683
72443251|NCT01227265|144399771|SUPERIORITY_OR_OTHER||Difference in Estimated Means|-0.2||||0.6968|TWO_SIDED|95.0|-0.92|0.61|||cLDA|||||0.61|-0.92|0.6968
72443252|NCT01227265|144399771|SUPERIORITY_OR_OTHER||Difference in Estimated Means|0.2||||0.6142|TWO_SIDED|95.0|-0.57|0.97|||cLDA|||||0.97|-0.57|0.6142
72443253|NCT05028582|144399772|SUPERIORITY||Odds Ratio, log|5.19|||<|0.0001|TWO_SIDED|97.5|2.9|9.31|||Cochran-Mantel-Haenszel|Stratified by pooled study site, baseline S-IGA, and baseline B-IGA with multiple imputation to handle missing data|Stratified by pooled study site, baseline S-IGA, and baseline B-IGA with multiple imputation to handle missing data|S-IGA Success at Week 8||9.31|2.90|<0.0001
72443254|NCT05028582|144399773|SUPERIORITY||Odds Ratio (OR)|3.17|||<|0.0001|TWO_SIDED|97.5|1.75|5.73|||Cochran-Mantel-Haenszel|Stratified by pooled study site, baseline S-IGA, and baseline B-IGA with multiple imputation to handle missing data|Stratified by pooled study site, baseline S-IGA, and baseline B-IGA with multiple imputation to handle missing data|B-IGA Success at Week 8||5.73|1.75|<0.0001
72496800|NCT04024501|144523069|OTHER||Geometric mean ratio|53.55|||||TWO_SIDED|90.0|45.09|63.59|||Mixed Model Analysis|The number of subjects in this analysis: 23||Pairwise comparison: Treatment 3/Treatment 4||63.59|45.09|
72496801|NCT04024501|144523069|OTHER||Geometric mean ratio|77.05|||||TWO_SIDED|90.0|65.19|91.06|||Mixed Model Analysis|The number of subjects in this analysis: 25||Pairwise comparison: Treatment 4/Treatment 1||91.06|65.19|
72496802|NCT04024501|144523069|OTHER||Geometric mean ratio|76.75|||||TWO_SIDED|90.0|64.94|90.71|||Mixed Model Analysis|The number of subjects in this analysis: 25||Pairwise comparison: Treatment 4/Treatment 2||90.71|64.94|
72443255|NCT05028582|144399774|OTHER|SI-NRS Success at Week 4|Odds Ratio (OR)|4.67||||0.0005|TWO_SIDED|97.5|1.6|13.62|||Cochran-Mantel-Haenszel|Stratified by pooled study site, baseline S IGA, and baseline B-IGA with multiple imputation to handle missing data|Stratified by pooled study site, baseline S IGA, and baseline B-IGA with multiple imputation to handle missing data|||13.62|1.60|0.0005
72443256|NCT05028582|144399775|SUPERIORITY||Odds Ratio (OR)|4.39|||<|0.0001|TWO_SIDED|97.5|2.01|9.55|||Cochran-Mantel-Haenszel|Stratified by pooled study site, baseline S IGA, and baseline B-IGA with multiple imputation to handle missing data|Stratified by pooled study site, baseline S IGA, and baseline B-IGA with multiple imputation to handle missing data|SI-NRS Success at Week 4||9.55|2.01|<0.0001
72443257|NCT05028582|144399776|OTHER|SI-NRS Success at Week 8|Odds Ratio (OR)|5.41|||<|0.0001|TWO_SIDED|97.5|2.49|11.78|||Cochran-Mantel-Haenszel|Stratified by pooled study site, baseline S IGA, and baseline B-IGA with multiple imputation to handle missing data|Stratified by pooled study site, baseline S IGA, and baseline B-IGA with multiple imputation to handle missing data|||11.78|2.49|<0.0001
72443258|NCT05028582|144399777|SUPERIORITY|SI-NRS Change from Baseline Day 1|LS Mean Difference|-0.35||||0.0164|TWO_SIDED|97.5|-0.68|-0.02|||ANCOVA|ANCOVA terms of treatment, pooled study site, baseline S-IGA, baseline B-IGA, and baseline SI-NRS score|ANCOVA terms of treatment, pooled study site, baseline S-IGA, baseline B-IGA, and baseline SI-NRS score|||-0.02|-0.68|0.0164
72443259|NCT05028582|144399778|SUPERIORITY|SI-NRS Change from Baseline Day 1|LS Mean Difference|-0.76|||<|0.0001|TWO_SIDED|97.5|-1.12|-0.39|||ANCOVA|ANCOVA terms of treatment, pooled study site, baseline S-IGA, baseline B-IGA, and baseline SI-NRS score|ANCOVA terms of treatment, pooled study site, baseline S-IGA, baseline B-IGA, and baseline SI-NRS score|||-0.39|-1.12|<0.0001
72443260|NCT05028582|144399779|SUPERIORITY|Change from Baseline in Weekly SI-NRS at Week 1|LS Mean Difference|-0.55||||0.0002|TWO_SIDED|97.5|-0.87|-0.22|||ANCOVA|ANCOVA terms of treatment, pooled study site, baseline S-IGA, baseline B-IGA, and baseline SI-NRS score|ANCOVA terms of treatment, pooled study site, baseline S-IGA, baseline B-IGA, and baseline SI-NRS score|||-0.22|-0.87|0.0002
72443261|NCT05028582|144399780|OTHER|WI-NRS Success at Week 8|Odds Ratio (OR)|4.14|||<|0.0001|TWO_SIDED|97.5|2.01|8.52|||Cochran-Mantel-Haenszel|Stratified by pooled study site, baseline S-IGA, and baseline B-IGA|Stratified by pooled study site, baseline S-IGA, and baseline B-IGA|||8.52|2.01|<0.0001
72443262|NCT05028582|144399781|SUPERIORITY|PASI-75 at Week 8|Odds Ratio (OR)|5.42|||<|0.0001|TWO_SIDED|97.5|2.73|10.75|||Cochran-Mantel-Haenszel|Stratified by pooled study site, baseline S-IGA, and baseline B-IGA with multiple imputation to handle missing data|Stratified by pooled study site, baseline S-IGA, and baseline B-IGA with multiple imputation to handle missing data|||10.75|2.73|<0.0001
72443263|NCT05028582|144399782|SUPERIORITY|PSD Aggregate Score Change at Week 8|LS Mean Difference|-5.12|||<|0.0001|TWO_SIDED|97.5|-6.64|-3.6|||ANCOVA|Covariate terms of treatment, pooled study site, baseline S-IGA, baseline B-IGA and baseline PSD aggregate score \& multiple imputation of missing data|Covariate terms of treatment, pooled study site, baseline S-IGA, baseline B-IGA and baseline PSD aggregate score \& multiple imputation of missing data|||-3.60|-6.64|<0.0001
72443264|NCT05028582|144399783|SUPERIORITY|PSD Itching Week 8|Odds Ratio (OR)|4.59|||<|0.0001|TWO_SIDED|97.5|2.1|10.04|||Cochran-Mantel-Haenszel|Stratified by pooled study site, baseline S-IGA, and baseline B-IGA with multiple imputation to handle missing data|Stratified by pooled study site, baseline S-IGA, and baseline B-IGA with multiple imputation to handle missing data|||10.04|2.10|<0.0001
72443265|NCT05028582|144399784|SUPERIORITY|PSD Pain Week 8|Odds Ratio (OR)|3.23|||<|0.0001|TWO_SIDED|97.5|1.83|5.68|||Cochran-Mantel-Haenszel|Stratified by pooled study site, baseline S-IGA, and baseline B-IGA with multiple imputation to handle missing data|Stratified by pooled study site, baseline S-IGA, and baseline B-IGA with multiple imputation to handle missing data|||5.68|1.83|<0.0001
72443266|NCT05028582|144399785|SUPERIORITY|PSD Scaling Week 8|Odds Ratio (OR)|4.56|||<|0.0001|TWO_SIDED|97.5|2.28|9.08|||Cochran-Mantel-Haenszel|Stratified by pooled study site, baseline S-IGA, and baseline B-IGA with multiple imputation to handle missing data|Stratified by pooled study site, baseline S-IGA, and baseline B-IGA with multiple imputation to handle missing data|||9.08|2.28|<0.0001
72443267|NCT05028582|144399786|OTHER|PSD Total Score 0 at Week 8|Odds Ratio (OR)|3.27||||0.0012|TWO_SIDED|97.5|1.39|7.68|||Cochran-Mantel-Haenszel|Stratified by pooled study site, baseline S-IGA, and baseline B-IGA|Stratified by pooled study site, baseline S-IGA, and baseline B-IGA|||7.68|1.39|0.0012
72560033|NCT01139762|144650642|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.04|||<|0.001|TWO_SIDED|95.0|-1.62|-0.46||P-value is for IPSS voiding (obstructive) subscore - 12 weeks.|Mixed Model Repeated Measures Analysis|The Kenward-Roger approximation was used to estimate denominator degrees of freedom.||MMRM model includes treatment, region, visit, and treatment-by-visit interaction as fixed effects, and subject as a random effect. Baseline total IPSS was the covariate. No imputation of missing total IPSS data was performed. The within-subject errors were modeled using an unstructured covariance structure.||-0.46|-1.62|<0.001
72443268|NCT05028582|144399787|SUPERIORITY|PSSI-75 at Week 8|Odds Ratio (OR)|5.4|||<|0.0001|TWO_SIDED|97.5|2.98|9.77|||Cochran-Mantel-Haenszel|Stratified by pooled study site, baseline S IGA, and baseline B IGA with multiple imputation to handle missing data|Stratified by pooled study site, baseline S IGA, and baseline B IGA with multiple imputation to handle missing data|||9.77|2.98|<0.0001
72496803|NCT04024501|144523069|OTHER||Geometric mean ratio|84.23|||||TWO_SIDED|90.0|70.93|100.03|||Mixed Model Analysis|The number of subjects in this analysis: 23||Pairwise comparison: Treatment 5/Treatment 1||100.03|70.93|
72619157|NCT03760640|144769024|SUPERIORITY||LS Mean Difference|3.0||||0.011|TWO_SIDED|90.0|1.1|4.9|||Mixed Models Analysis|||||4.90|1.10|0.011
72619158|NCT03760640|144769025|SUPERIORITY||LS Mean Difference|0.56||||0.557|TWO_SIDED|90.0|-1.02|2.14|||Mixed Models Analysis|||||2.14|-1.02|0.557
72443269|NCT05028582|144399788|SUPERIORITY|S-IGA Clear at Week 8|Odds Ratio (OR)|6.77|||<|0.0001|TWO_SIDED|97.5|3.04|15.05|||Cochran-Mantel-Haenszel|Stratified by pooled study site, baseline S-IGA, and baseline B-IGA with multiple imputation to handle missing data|Stratified by pooled study site, baseline S-IGA, and baseline B-IGA with multiple imputation to handle missing data|||15.05|3.04|<0.0001
72496804|NCT04024501|144523069|OTHER||Geometric mean ratio|83.9|||||TWO_SIDED|90.0|70.65|99.64|||Mixed Model Analysis|The number of subjects in this analysis: 23||Pairwise comparison: Treatment 5/Treatment 2||99.64|70.65|
72496805|NCT04024501|144523069|OTHER||Geometric mean ratio|204.16|||||TWO_SIDED|90.0|171.22|243.42|||Mixed Model Analysis|The number of subjects in this analysis: 23||Pairwise comparison: Treatment 5/Treatment 3||243.42|171.22|
72443270|NCT05028582|144399789|SUPERIORITY|S-IGA Success Week 2|Odds Ratio (OR)|4.1|||<|0.0001|TWO_SIDED|97.5|1.84|9.13|||Cochran-Mantel-Haenszel|Stratified by pooled study site, baseline S-IGA, and baseline B-IGA with multiple imputation to handle missing data|Stratified by pooled study site, baseline S-IGA, and baseline B-IGA with multiple imputation to handle missing data|||9.13|1.84|<0.0001
72443271|NCT05028582|144399790|SUPERIORITY|S-IGA Success at Week 4|Odds Ratio (OR)|4.82|||<|0.0001|TWO_SIDED|97.5|2.62|8.84|||Cochran-Mantel-Haenszel|Stratified by pooled study site, baseline S-IGA, and baseline B-IGA with multiple imputation to handle missing data|Stratified by pooled study site, baseline S-IGA, and baseline B-IGA with multiple imputation to handle missing data|||8.84|2.62|<0.0001
72443272|NCT05028582|144399791|SUPERIORITY|Change from Baseline in PASI Week 2|LS Mean Difference|-1.28|||<|0.0001|TWO_SIDED|97.5|-1.71|-0.85|||ANCOVA|Covariate terms of treatment, pooled study site, baseline S-IGA, baseline B-IGA, and baseline PASI score \& multiple imputation to handle missing data|Covariate terms of treatment, pooled study site, baseline S-IGA, baseline B-IGA, and baseline PASI score \& multiple imputation to handle missing data|||-0.85|-1.71|<0.0001
72443273|NCT05769595|144399804|OTHER||Geometric Mean Ratio|2.51|||||TWO_SIDED|90.0|2.24|2.82|||||Geometric mean ratio is MK-2060/placebo|||2.82|2.24|
72443274|NCT03683069|144399810|SUPERIORITY|||||||0.823|||||||Regression, Linear|||adjusted to medication dose, sex, age, race||||0.823
72443275|NCT03683069|144399810|SUPERIORITY|||||||0.839|||||||Regression, Linear|||diastolic bp adjusted for medication dose sex,age, race||||.8390
72443276|NCT03683069|144399811|SUPERIORITY|||||||0.0101|||||||Wilcoxon (Mann-Whitney)|||||||.0101
72443277|NCT03683069|144399812|SUPERIORITY|||||||0.59|||||||ANOVA|||||||0.59
72496806|NCT04024501|144523069|OTHER||Geometric mean ratio|109.32|||||TWO_SIDED|90.0|92.06|129.83|||Mixed Model Analysis|The number of subjects in this analysis: 23||Pairwise comparison: Treatment 5/Treatment 4||129.83|92.06|
72496807|NCT04024501|144523070|OTHER||Geometric mean ratio|124.99|||||TWO_SIDED|90.0|101.09|154.54|||Mixed Model Analysis|The number of subjects in this analysis: 25||Pairwise comparison: Treatment 2/Treatment 1||154.54|101.09|
72443278|NCT03683069|144399813|SUPERIORITY||Hazard Ratio, log|0.7022||||0.09|TWO_SIDED||||||Kaplan-Meier using Gehan-Breslow-Wilcoxo|||||||.09
72443279|NCT05857644|144399840|OTHER||Geometric mean ratio|84.33|||||TWO_SIDED|90.0|50.94|139.59|||||Mild Hepatic Impairment versus No Hepatic Impairment|||139.59|50.94|
72443280|NCT05857644|144399840|OTHER||Geometric mean ratio|90.89|||||TWO_SIDED|90.0|54.91|150.45|||||Moderate Hepatic Impairment versus No Hepatic Impairment|||150.45|54.91|
72443281|NCT05857644|144399840|OTHER||Geometric mean ratio|157.23|||||TWO_SIDED|90.0|84.81|291.49|||||Severe Hepatic Impairment versus No Hepatic Impairment|||291.49|84.81|
72496808|NCT04024501|144523070|OTHER||Geometric mean ratio|33.77|||||TWO_SIDED|90.0|27.15|42.01|||Mixed Model Analysis|The number of subjects in this analysis: 23||Pairwise comparison: Treatment 3/Treatment 1||42.01|27.15|
72496809|NCT04024501|144523070|OTHER||Geometric mean ratio|27.02|||||TWO_SIDED|90.0|21.72|33.61|||Mixed Model Analysis|The number of subjects in this analysis: 23||Pairwise comparison: Treatment 3/Treatment 2||33.61|21.72|
72619159|NCT03760640|144769026|SUPERIORITY||LS Mean Difference|-0.04||||0.548|TWO_SIDED|90.0|-0.15|0.07|||Mixed Models Analysis|||||0.07|-0.15|0.548
72619160|NCT03760640|144769028|SUPERIORITY||LS Mean Difference|0.49||||0.577|TWO_SIDED|90.0|-0.97|1.94|||Mixed Models Analysis|||||1.94|-0.97|0.577
72443282|NCT05857644|144399841|OTHER||Geometric mean ratio|82.17|||||TWO_SIDED|90.0|49.24|137.11|||||Mild Hepatic Impairment versus No Hepatic Impairment|||137.11|49.24|
72443283|NCT05857644|144399841|OTHER||Geometric mean ratio|130.82|||||TWO_SIDED|90.0|78.4|218.3|||||Moderate Hepatic Impairment versus No Hepatic Impairment|||218.30|78.40|
72443284|NCT05857644|144399841|OTHER||Geometric mean ratio|385.52|||||TWO_SIDED|90.0|205.92|721.77|||||Severe Hepatic Impairment versus No Hepatic Impairment|||721.77|205.92|
72443285|NCT05857644|144399842|OTHER||Geometric mean ratio|82.99|||||TWO_SIDED|90.0|50.53|136.28|||||Mild Hepatic Impairment versus No Hepatic Impairment|||136.28|50.53|
72443286|NCT05857644|144399842|OTHER||Geometric mean ratio|131.52|||||TWO_SIDED|90.0|80.09|215.99|||||Moderate Hepatic Impairment versus No Hepatic Impairment|||215.99|80.09|
72443287|NCT05857644|144399842|OTHER||Geometric mean ratio|392.1|||||TWO_SIDED|90.0|213.57|719.85|||||Severe Hepatic Impairment versus No Hepatic Impairment|||719.85|213.57|
72443288|NCT03547908|144399851|NON_INFERIORITY|A sample size of 240 participants randomized in a 1:1 ratio to 2 treatment groups, achieved 90% power to detect a non-inferiority margin of 12% between the 2 treatment groups. For the sample size and power computation, it is assumed that both treatment groups have a response rate of 91% (based on Gilead Studies GS-US-380-1489 and GS-US-380-1490), that the non-inferiority margin is 12%, and that the significance level of the test is at a one-sided 0.025 level.|Difference in Percentages|4.1|||||TWO_SIDED|95.001|-2.5|10.8|||||The difference in percentages of participants between groups and their 95.001% confidence intervals (CI)s were calculated based on Mantel-Haenszel (MH) proportions adjusted by baseline HIV-1 RNA stratum (≤ 100,000 vs. \> 100,000 copies/mL).|||10.8|-2.5|
72443289|NCT03547908|144399851|SUPERIORITY|||||||0.2113|||||||Cochran-Mantel-Haenszel|The p-value was calculated from Cochran-Mantel-Haenszel (CMH) test stratified by baseline HIV-1 RNA stratum (≤ 100,000 vs. \> 100,000 copies/mL).||||||0.2113
72443290|NCT03547908|144399852|NON_INFERIORITY|A sample size of 240 participants provided 81% power to detect a non-inferiority margin of 12% between the 2 treatment groups. This assumed that both treatment groups have a response rate of 88% (based on Gilead Studies GS-US-320-0108 and GS-US-320-0110), that the non-inferiority margin is 12%, and that the significance level of the test is at a one-sided 0.025 level.|Difference in Percentages|16.6|||||TWO_SIDED|95.001|5.9|27.3|||||||The difference in percentages of participants with HBV DNA \< 29 IU/mL between treatment groups and its 95.001% CI were calculated based on the MH proportions adjusted by baseline HBeAg status (positive vs negative) and baseline HBV DNA category (\< 8 log10 IU/mL vs ≥ 8 log10 IU/mL).|27.3|5.9|
72496810|NCT04024501|144523070|OTHER||Geometric mean ratio|36.84|||||TWO_SIDED|90.0|29.61|45.82|||Mixed Model Analysis|The number of subjects in this analysis: 23||Pairwise comparison: Treatment 3/Treatment 4||45.82|29.61|
72496811|NCT04024501|144523070|OTHER||Geometric mean ratio|91.69|||||TWO_SIDED|90.0|74.15|113.36|||Mixed Model Analysis|The number of subjects in this analysis: 25||Pairwise comparison: Treatment 4/Treatment 1||113.36|74.15|
72496812|NCT04024501|144523070|OTHER||Geometric mean ratio|73.36|||||TWO_SIDED|90.0|59.33|90.7|||Mixed Model Analysis|The number of subjects in this analysis: 25||Pairwise comparison: Treatment 4/Treatment 2||90.70|59.33|
72560034|NCT01139762|144650642|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.73||||0.015|TWO_SIDED|95.0|-1.32|-0.14||P-value is IPSS voiding (obstructive) subscore - 26 weeks.|Mixed Model Repeated Measures Analysis|The Kenward-Roger approximation was used to estimate denominator degrees of freedom.||MMRM model includes treatment, region, visit, and treatment-by-visit interaction as fixed effects, and subject as a random effect. Baseline total IPSS was the covariate. No imputation of missing total IPSS data was performed. The within-subject errors were modeled using an unstructured covariance structure.||-0.14|-1.32|0.015
72622371|NCT05524948|144774641|OTHER||Adjusted Mean Difference|-2.17|STANDARD_ERROR_OF_MEAN|0.204|<|0.0001|TWO_SIDED|95.0|-2.58|-1.77|||ANCOVA|Analysis was performed using ANCOVA model with study product and gender as a factor and Baseline overall breath organoleptic score as a covariate.|Adjusted mean difference was calculated as experimental dentifrice minus reference dentifrice.|||-1.77|-2.58|<0.0001
72388572|NCT01709513|144285310|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Mean Difference|-18.7|||<|0.0001|TWO_SIDED|95.0|-25.5|-11.8||Threshold for significance ≤ 0.05.|Regression, Robust|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant). Statistical analysis used a multiple imputation approach followed by a robust regression model.||-11.8|-25.5|<0.0001
72388573|NCT01709513|144285311|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.9|||=|0.6997|TWO_SIDED|95.0|-3.8|5.6||Threshold for significance ≤ 0.05.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).||5.6|-3.8|=0.6997
72388574|NCT01543958|144285347|SUPERIORITY_OR_OTHER|||||||0.87||||||not adjusted for multiple comparisons|Sign test|no other adjustment||||||0.87
72388575|NCT01543958|144285348|SUPERIORITY_OR_OTHER|||||||0.62||||||Not adjusted for multiple comparisons|Sign test|no other adjustment||||||0.62
72388576|NCT01945281|144285402|OTHER|Miettinen \& Nurminen method stratified by stratum (Weight category based on weight at study entry) with Cochran Mantel-Haenszel's weights.|Difference in Percentage|-0.9|||||TWO_SIDED|95.0|-24.3|27.7|||||Caspofungin minus Amphotericin|||27.7|-24.3|
72388577|NCT01945281|144285403|OTHER|Miettinen \& Nurminen method stratified by stratum (Weight category based on weight at study entry) with Cochran Mantel-Haenszel's weights.|Difference in Percentage|-6.3|||||TWO_SIDED|95.0|-30.2|22.6|||||Caspofungin minus Amphotericin|||22.6|-30.2|
72388578|NCT00885846|144285482|NON_INFERIORITY_OR_EQUIVALENCE|Regression analysis performed for equal variance at baseline.||||||0.664||95.0|||||Repeated ANOVA|degrees of freedom = 2||Power analysis suggested 27 participants, 9 in each group.||||0.664
72388579|NCT03719612|144285483|SUPERIORITY|Difference between Echo Enhanced and Echo Unenhanced|Mean Difference (Final Values)|-0.38|STANDARD_DEVIATION|4.947||0.358|TWO_SIDED||||||t-test, 2 sided|Paired t-test||||||0.358
72388580|NCT03719612|144285483|SUPERIORITY|Difference between Echo Enhanced and Echo Unenhanced|Mean Difference (Final Values)|-0.12|STANDARD_DEVIATION|5.699||0.804|TWO_SIDED||||||t-test, 2 sided|Paired t-test||||||0.804
72388581|NCT03719612|144285483|SUPERIORITY|Difference between Echo Enhanced and Echo Unenhanced|Mean Difference (Final Values)|-0.33|STANDARD_DEVIATION|4.412||0.371|TWO_SIDED||||||t-test, 2 sided|Paired t-test||||||0.371
72388582|NCT03719612|144285484|SUPERIORITY|Difference between Echo Enhanced and Echo Unenhanced|Mean Difference (Final Values)|-1.28|STANDARD_DEVIATION|3.952||0.03|TWO_SIDED||||||t-test, 2 sided|Paired t-test||||||0.030
72388583|NCT03719612|144285484|SUPERIORITY|Difference between Echo Enhanced and Echo Unenhanced|Mean Difference (Final Values)|-0.66|STANDARD_DEVIATION|4.466||0.312|TWO_SIDED||||||t-test, 2 sided|Paired t-test||||||0.312
72388584|NCT03719612|144285484|SUPERIORITY|Difference between Echo Enhanced and Echo Unenhanced|Mean Difference (Final Values)|-0.65|STANDARD_DEVIATION|4.725||0.347|TWO_SIDED||||||t-test, 2 sided|Paired t-test||||||0.347
72388585|NCT03719612|144285485|OTHER||Intra-class Correlation Coefficient|0.984|||||TWO_SIDED|95.0|0.977|0.988||||||Inter-Reader Variability Echo Enhanced||0.988|0.977|
72388586|NCT03719612|144285485|OTHER||Intra-class Correlation Coefficient|0.953|||||TWO_SIDED|95.0|0.936|0.966||||||Inter-Reader Variability Echo Unenhanced||0.966|0.936|
72388587|NCT03719612|144285485|OTHER||Intra-class Correlation Coefficient|0.97|||||TWO_SIDED|95.0|0.958|0.978||||||Inter-Reader Variability Echo Enhanced||0.978|0.958|
72388588|NCT03719612|144285485|OTHER||Intra-class Correlation Coefficient|0.944|||||TWO_SIDED|95.0|0.923|0.959||||||Inter-Reader Variability Echo Unenhanced||0.959|0.923|
72388589|NCT03719612|144285485|OTHER||Intra-class Correlation Coefficient|0.961|||||TWO_SIDED|95.0|0.947|0.972||||||Inter-Reader Variability Echo Enhanced||0.972|0.947|
72388590|NCT03719612|144285485|OTHER||Intra-class Correlation Coefficient|0.942|||||TWO_SIDED|95.0|0.92|0.958||||||Inter-Reader Variability Echo Unenhanced||0.958|0.920|
72388591|NCT03719612|144285486|OTHER||Intra-class Correlation Coefficient|0.984|||||TWO_SIDED|95.0|0.978|0.988||||||Inter-Reader Variability End Diastolic Echo Enhanced||0.988|0.978|
72388592|NCT03719612|144285486|OTHER||Intra-class Correlation Coefficient|0.976|||||TWO_SIDED|95.0|0.967|0.983||||||Inter-Reader Variability End Diastolic Echo Unenhanced||0.983|0.967|
72388593|NCT03719612|144285486|OTHER||Intra-class Correlation Coefficient|0.973|||||TWO_SIDED|95.0|0.963|0.981||||||Inter-Reader Variability End Diastolic Echo Enhanced||0.981|0.963|
72388594|NCT03719612|144285486|OTHER||Intra-class Correlation Coefficient|0.935|||||TWO_SIDED|95.0|0.91|0.952||||||Inter-Reader Variability End Diastolic Echo Unenhanced||0.952|0.910|
72388595|NCT03719612|144285486|OTHER||Intra-class Correlation Coefficient|0.973|||||TWO_SIDED|95.0|0.962|0.98||||||Inter-Reader Variability End Diastolic Echo Enhanced||0.980|0.962|
72388596|NCT03719612|144285486|OTHER||Intra-class Correlation Coefficient|0.924|||||TWO_SIDED|95.0|0.896|0.945||||||Inter-Reader Variability End Diastolic Echo Unenhanced||0.945|0.896|
72388597|NCT03719612|144285486|OTHER||Intra-class Correlation Coefficient|0.989|||||TWO_SIDED|95.0|0.984|0.992||||||Inter-Reader Variability End Systolic Echo Enhanced||0.992|0.984|
72388598|NCT03719612|144285486|OTHER||Intra-class Correlation Coefficient|0.983|||||TWO_SIDED|95.0|0.977|0.988||||||Inter-Reader Variability End Systolic Echo Unenhanced||0.988|0.977|
72388599|NCT03719612|144285486|OTHER||Intra-class Correlation Coefficient|0.984|||||TWO_SIDED|95.0|0.978|0.989||||||Inter-Reader Variability End Systolic Echo Enhanced||0.989|0.978|
72388600|NCT03719612|144285486|OTHER||Intra-class Correlation Coefficient|0.948|||||TWO_SIDED|95.0|0.928|0.962||||||Inter-Reader Variability End Systolic Echo Unenhanced||0.962|0.928|
72388601|NCT03719612|144285486|OTHER||Intra-class Correlation Coefficient|0.978|||||TWO_SIDED|95.0|0.969|0.984||||||Inter-Reader Variability End Systolic Echo Enhanced||0.984|0.969|
72388602|NCT03719612|144285486|OTHER||Intra-class Correlation Coefficient|0.942|||||TWO_SIDED|95.0|0.92|0.958||||||Inter-Reader Variability End Systolic Echo Unenhanced||0.958|0.920|
72388603|NCT03719612|144285487|OTHER||Intra-class Correlation Coefficient|0.975|||||TWO_SIDED|95.0|0.956|0.986||||||Inter-Reader Variability Echo Enhanced Sub-Optimal Echocardiograms||0.986|0.956|
72388604|NCT03719612|144285487|OTHER||Intra-class Correlation Coefficient|0.936|||||TWO_SIDED|95.0|0.888|0.963||||||Inter-Reader Variability Echo Unenhanced Sub-Optimal Echocardiograms||0.963|0.888|
72388605|NCT03719612|144285487|OTHER||Intra-class Correlation Coefficient|0.961|||||TWO_SIDED|95.0|0.931|0.978||||||Inter-Reader Variability Echo Enhanced Sub-Optimal Echocardiograms||0.978|0.931|
72388606|NCT03719612|144285487|OTHER||Intra-class Correlation Coefficient|0.921|||||TWO_SIDED|95.0|0.864|0.955||||||Inter-Reader Variability Echo Unenhanced Sub-Optimal Echocardiograms||0.955|0.864|
72388607|NCT03719612|144285487|OTHER||Intra-class Correlation Coefficient|0.947|||||TWO_SIDED|95.0|0.907|0.97||||||Inter-Reader Variability Echo Enhanced Sub-Optimal Echocardiograms||0.970|0.907|
72388608|NCT03719612|144285487|OTHER||Intra-class Correlation Coefficient|0.903|||||TWO_SIDED|95.0|0.834|0.945||||||Inter-Reader Variability Echo Unenhanced Sub-Optimal Echocardiograms||0.945|0.834|
72388609|NCT03719612|144285488|OTHER||Intra-class Correlation Coefficient|0.984|||||TWO_SIDED|95.0|0.971|0.991||||||Inter-Reader Variability End Diastolic Echo Enhanced Sub-Optimal Echocardiograms||0.991|0.971|
72388610|NCT03719612|144285488|OTHER||Intra-class Correlation Coefficient|0.975|||||TWO_SIDED|95.0|0.956|0.986||||||Inter-Reader Variability End Diastolic Echo Unenhanced Sub-Optimal Echocardiograms||0.986|0.956|
72388611|NCT03719612|144285488|OTHER||Intra-class Correlation Coefficient|0.977|||||TWO_SIDED|95.0|0.959|0.987||||||Inter-Reader Variability End Diastolic Echo Enhanced Sub-Optimal Echocardiograms||0.987|0.959|
72388612|NCT03719612|144285488|OTHER||Intra-class Correlation Coefficient|0.94|||||TWO_SIDED|95.0|0.896|0.966||||||Inter-Reader Variability End Diastolic Echo Unenhanced Sub-Optimal Echocardiograms||0.966|0.896|
72388613|NCT03719612|144285488|OTHER||Intra-class Correlation Coefficient|0.977|||||TWO_SIDED|95.0|0.959|0.987||||||Inter-Reader Variability End Diastolic Echo Enhanced Sub-Optimal Echocardiograms||0.987|0.959|
72388614|NCT03719612|144285488|OTHER||Intra-class Correlation Coefficient|0.923|||||TWO_SIDED|95.0|0.866|0.956||||||Inter-Reader Variability End Diastolic Echo Unenhanced Sub-Optimal Echocardiograms||0.956|0.866|
72388615|NCT03719612|144285488|OTHER||Intra-class Correlation Coefficient|0.99|||||TWO_SIDED|95.0|0.982|0.994||||||Inter-Reader Variability End Systolic Echo Enhanced Sub-Optimal Echocardiograms||0.994|0.982|
72443291|NCT03547908|144399852|SUPERIORITY|||||||0.0023|||||||Cochran-Mantel-Haenszel|The p-value was from CMH test stratified by baseline HBeAg status (positive vs negative) and HBV DNA category (\< 8 log10 IU/mL vs ≥ 8 log10 IU/mL).||||||0.0023
72496813|NCT04024501|144523070|OTHER||Geometric mean ratio|67.62|||||TWO_SIDED|90.0|54.37|84.12|||Mixed Model Analysis|The number of subjects in this analysis: 23||Pairwise comparison: Treatment 5/Treatment 1||84.12|54.37|
72388616|NCT03719612|144285488|OTHER||Intra-class Correlation Coefficient|0.976|||||TWO_SIDED|95.0|0.957|0.986||||||Inter-Reader Variability End Systolic Echo Unenhanced Sub-Optimal Echocardiograms||0.986|0.957|
72388617|NCT03719612|144285488|OTHER||Intra-class Correlation Coefficient|0.985|||||TWO_SIDED|95.0|0.973|0.991||||||Inter-Reader Variability End Systolic Echo Enhanced Sub-Optimal Echocardiograms||0.991|0.973|
72388618|NCT03719612|144285488|OTHER||Intra-class Correlation Coefficient|0.929|||||TWO_SIDED|95.0|0.876|0.959||||||Inter-Reader Variability End Systolic Echo Unenhanced Sub-Optimal Echocardiograms||0.959|0.876|
72388619|NCT03719612|144285488|OTHER||Intra-class Correlation Coefficient|0.981|||||TWO_SIDED|95.0|0.966|0.989||||||Inter-Reader Variability End Systolic Echo Enhanced Sub-Optimal Echocardiograms||0.989|0.966|
72388620|NCT03719612|144285488|OTHER||Intra-class Correlation Coefficient|0.916|||||TWO_SIDED|95.0|0.855|0.952||||||Inter-Reader Variability End Systolic Echo Unenhanced Sub-Optimal Echocardiograms||0.952|0.855|
72388621|NCT01768286|144285561|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||A 2-sided 1-sample binomial test was used to compare over the historical SVR12 rate of 25%. To control the family-wise type I error rate at 0.05, the Hochberg procedure was applied, from which the adjusted p-values were obtained.|Binomial test|||||||<0.001
72388622|NCT01768286|144285561|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||A 2-sided 1-sample binomial test was used to compare over the historical SVR12 rate of 25%. To control the family-wise type I error rate at 0.05, the Hochberg procedure was applied, from which the adjusted p-values were obtained.|Binomial test|||||||<0.001
72388623|NCT01768286|144285561|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||A 2-sided 1-sample binomial test was used to compare over the historical SVR12 rate of 25%. To control the family-wise type I error rate at 0.05, the Hochberg procedure was applied, from which the adjusted p-values were obtained.|Binomial test|||||||<0.001
72388624|NCT01768286|144285561|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||A 2-sided 1-sample binomial test was used to compare over the historical SVR12 rate of 25%. To control the family-wise type I error rate at 0.05, the Hochberg procedure was applied, from which the adjusted p-values were obtained.|Binomial test|||||||<0.001
72388625|NCT03344796|144285582|SUPERIORITY||||||<|0.01|||||||Chi-squared|||||||<0.01
72388626|NCT03344796|144285583|SUPERIORITY||||||<|0.001|||||||Chi-squared, Corrected|||||||<0.001
72388627|NCT03344796|144285584|SUPERIORITY||||||<|0.01|||||||Chi-squared|||||||<0.01
72388628|NCT03344796|144285585|SUPERIORITY||||||<|0.1|||||||Chi-squared|||Knowledge of sun protection score at baseline compared with score after completion of the arm. The hypothesis is that the focus group, usability test and structured interviews arms will not have significant change in knowledge. It is expected that cohort studies 1 and 2 will have significant change in knowledge of sun protection.||||< 0.1
72388629|NCT03298867|144285588|SUPERIORITY||Stratified difference in percentages|73.45|STANDARD_ERROR_OF_MEAN|7.43|<|0.001|TWO_SIDED|95.0|58.89|88.01||Two-sided p-value calculated assuming the test statistic was distributed as a standard normal random variable.|Cochran-Mantel-Haenszel||Stratified difference (teprotumumab - placebo) is a weighted average of the difference within each stratum. Estimates from the 2 strata (tobacco user, tobacco non-user) were combined with Cochran-Mantel-Haenszel (CMH) weights.|||88.01|58.89|<0.001
72388630|NCT03298867|144285589|SUPERIORITY||Stratified difference in percentages|70.82|STANDARD_ERROR_OF_MEAN|7.62|<|0.001|TWO_SIDED|95.0|55.89|85.75||Two-sided p-value calculated assuming the test statistic was distributed as a standard normal random variable.|Cochran-Mantel-Haenszel||Stratified difference (teprotumumab - placebo) is a weighted average of the difference within each stratum. Estimates from the 2 strata (tobacco user, tobacco non-user) were combined with CMH weights.|||85.75|55.89|<0.001
72619161|NCT03016403|144769029|SUPERIORITY||Mean Difference (Final Values)|1.75||||0.0057|TWO_SIDED|95.0|0.52|2.98||Since there are three primary outcomes (depression, anxiety and coping scores) in the study, the significance level was set a priori at 0.0167 (alpha = 0.05/3).|Mixed Models Analysis|The pvalue corresponds to the hypothesis of the interaction effect between time and group (intervention arm).|The estimate represents the difference in expected means at the 6-month time point between the intervention and usual care arms.|A linear mixed model (LMM) with random intercepts for both patients and clinics has been used, with adjustment for cancer type and cancer stage. The study was powered for testing the hypothesis of no group differences in change over the four time points (baseline, 6-weeks, 3-months and 6-months). A significant group by time interaction was hypothesized.||2.98|0.52|0.0057
72443292|NCT03547908|144399853|SUPERIORITY||Difference in Percentages|-0.3||||0.9427|TWO_SIDED|95.0|-8.9|8.3||P-value for the superiority test comparing the percentages of participants with HIV-1 RNA \< 50 copies/mL between treatment groups was from the CMH test stratified by baseline HIV-1 RNA stratum (≤ 100,000 vs \> 100,000 copies/mL).|Cochran-Mantel-Haenszel||The difference in percentages of participants with HIV-1 RNA \< 50 copies/mL between treatment groups and its 95% CI were calculated based on the MH proportions adjusted by baseline HIV-1 RNA stratum (≤ 100,000 vs \> 100,000 copies/mL).|||8.3|-8.9|0.9427
72443293|NCT03547908|144399854|OTHER||Difference in least squares mean (LSM)|24.0||||0.1701|TWO_SIDED|95.0|-10.0|58.0|||ANOVA|The p-value was calculated using ANOVA model adjusted by the baseline HIV-1 RNA stratum (≤ 100,000 vs. \> 100,000 copies/mL).|The difference in least squares means and its 95% CI were calculated using ANOVA model adjusted by the baseline HIV-1 RNA stratum (≤ 100,000 vs. \> 100,000 copies/mL).|||58|-10|0.1701
72443294|NCT03547908|144399855|OTHER||Difference in Least Squares Means|30.0||||0.1853|TWO_SIDED|95.0|-14.0|74.0||P-value was from ANOVA model adjusted by the baseline HIV-1 RNA stratum (\<= 100,000 vs. \> 100,000 copies/mL).|ANOVA||Difference in least squares means (Diff in LSM), and its 95% CI were from ANOVA model adjusted by the baseline HIV-1 RNA stratum (\<= 100,000 vs. \> 100,000 copies/mL).|||74|-14|0.1853
72443295|NCT03547908|144399856|OTHER||Difference in least squares mean (LSM)|0.59||||0.2839|TWO_SIDED|95.0|-0.49|1.67|||ANOVA|The p-value was calculated using ANOVA model adjusted by the baseline HIV-1 RNA stratum (≤ 100,000 vs. \> 100,000 copies/mL).|The difference in least squares means and its 95% CI were calculated using ANOVA model adjusted by the baseline HIV-1 RNA stratum (≤ 100,000 vs. \> 100,000 copies/mL).|||1.67|-0.49|0.2839
72443296|NCT03547908|144399857|OTHER||Difference in LSM|0.13||||0.8456|TWO_SIDED|95.0|-1.2|1.46||P-value was from ANOVA model adjusted by the baseline HIV-1 RNA stratum (\<= 100,000 vs. \> 100,000 copies/mL).|ANOVA||Difference in LSM and its 95% CI were from ANOVA model adjusted by the baseline HIV-1 RNA stratum (\<= 100,000 vs. \> 100,000 copies/mL).|||1.46|-1.20|0.8456
72443297|NCT03547908|144399858|SUPERIORITY|P-value for the superiority test comparing the percentages of participants with HBV DNA \< 29 IU/mL between treatment groups was from the CMH test stratified by baseline HBeAg status (positive vs negative) and baseline HBV DNA category (\< 8 log10 IU/mL vs ≥ 8 log10 IU/mL).|Difference in Percentages|2.6||||0.6367|TWO_SIDED|95.0|-8.3|13.4|||Cochran-Mantel-Haenszel|||The difference in percentages of participants with HBV DNA \< 29 IU/mL between treatment groups and its 95% CI were calculated based on the MH proportions adjusted by baseline HBeAg status (positive vs negative) and baseline HBV DNA category (\< 8 log10 IU/mL vs ≥ 8 log10 IU/mL).||13.4|-8.3|0.6367
72443298|NCT03547908|144399859|OTHER||Difference in Percentages|17.1||||0.0655|TWO_SIDED|95.0|-1.5|35.7|||Cochran-Mantel-Haenszel|P-value was calculated from CMH tests stratified by baseline HBeAg status (positive vs negative) and HBV DNA (\< 8 log10 IU/mL vs ≥ 8 log10 IU/mL).|The difference in percentages of participants between groups and their 95% CIs were calculated based on MH proportions adjusted by baseline HBeAg status (positive vs negative) and baseline HBV DNA (\< 8 log10 IU/mL vs ≥ 8 log10 IU/mL).|||35.7|-1.5|0.0655
72443299|NCT03547908|144399860|OTHER||Difference in Percentages|14.1||||0.1253|TWO_SIDED|95.0|-4.3|32.6|||Cochran-Mantel-Haenszel|P-value was from the CMH tests stratified by baseline HBeAg status (positive vs negative) and baseline HBV DNA (\< 8 log10 IU/mL vs \>= 8 log10 IU/mL).|Difference in the proportion between treatment groups and its 95% CI were calculated based on the MH proportions adjusted by baseline HBeAg status (positive vs negative) and baseline HBV DNA (\< 8 log10 IU/mL vs \>= 8 log10 IU/mL).|||32.6|-4.3|0.1253
72443300|NCT03547908|144399861|OTHER||Difference in Percentages|7.1||||0.0591|TWO_SIDED|95.0|-0.8|15.0|||Cochran-Mantel-Haenszel|P-value was from the CMH tests stratified by baseline HBeAg status (positive vs negative)and baseline HBV DNA (\< 8 log10 IU/mL vs ≥ 8 log10 IU/mL).|Difference in the percentages between treatment groups and its 95% CI were calculated based on the MH proportions adjusted by baseline HBeAg status (positive vs negative) and baseline HBV DNA (\< 8 log10 IU/mL vs ≥ 8 log10 IU/mL).|||15.0|-0.8|0.0591
72443301|NCT03547908|144399862|OTHER||Difference in Percentages|9.3||||0.0655|TWO_SIDED|95.0|-0.7|19.2||P value was from the CMH test stratified by baseline HBeAg status (positive vs negative) and baseline HBV DNA (\< 8 log10 IU/mL vs ≥ 8 log10 IU/mL). Statistically significant values are shown in bold.|Cochran-Mantel-Haenszel||Differences in percentages between treatment groups and their 95% CI were calculated based on MH proportions adjusted by baseline HBeAg status (positive vs negative) and baseline HBV DNA (\< 8 log10 IU/mL vs ≥ 8 log10 IU/mL).|||19.2|-0.7|0.0655
72443302|NCT04878354|144399897|SUPERIORITY||Mean Difference (Final Values)|1.29||||0.0004|TWO_SIDED|95.0|0.58|2.0|||Mixed Models Analysis||Placebo SLIT-tablet vs. tree SLIT-tablet|Multiple imputation was used to impute missing data under the hypothetical strategy. The square root transformed endpoint was analysed in a linear mixed effects (LME) model with treatment, cohort, and age group as fixed effects, and pollen station within cohort as a random effect with different residual errors specified for each treatment group. Back-transformation was used to estimate the absolute difference. Adjusted p-value.||2.00|0.58|0.0004
72496814|NCT04024501|144523070|OTHER||Geometric mean ratio|54.11|||||TWO_SIDED|90.0|43.5|67.3|||Mixed Model Analysis|The number of subjects in this analysis: 23||Pairwise comparison: Treatment 5/Treatment 2||67.30|43.50|
72496815|NCT04024501|144523070|OTHER||Geometric mean ratio|200.23|||||TWO_SIDED|90.0|160.15|250.32|||Mixed Model Analysis|The number of subjects in this analysis: 23||Pairwise comparison: Treatment 5/Treatment 3||250.32|160.15|
72496816|NCT04024501|144523070|OTHER||Geometric mean ratio|73.76|||||TWO_SIDED|90.0|59.3|91.75|||Mixed Model Analysis|The number of subjects in this analysis: 23||Pairwise comparison: Treatment 5/Treatment 4||91.75|59.30|
72443303|NCT04878354|144399898|SUPERIORITY||Mean Difference (Final Values)|0.85||||0.001|TWO_SIDED|95.0|0.34|1.35|||Mixed Models Analysis||Placebo SLIT-tablet vs. tree SLIT-tablet|Multiple imputation was used to impute missing data under the hypothetical strategy. The square root transformed endpoint was analysed in a linear mixed effects (LME) model with treatment, cohort, and age group as fixed effects, and pollen station within cohort as a random effect with different residual errors specified for each treatment group. Back-transformation was used to estimate the absolute difference. Adjusted p-value.||1.35|0.34|0.0010
72443304|NCT04878354|144399899|SUPERIORITY||Mean Difference (Final Values)|0.37||||0.0354|TWO_SIDED|95.0|0.03|0.71|||Mixed Models Analysis||Placebo SLIT-tablet vs. tree SLIT-tablet|Multiple imputation was used to impute missing data under the hypothetical strategy. The square root transformed endpoint was analysed in a linear mixed effects (LME) model with treatment, cohort, and age group as fixed effects, and pollen station within cohort as a random effect with different residual errors specified for each treatment group. Back-transformation was used to estimate the absolute difference. Adjusted p-value.||0.71|0.03|0.0354
72443305|NCT04878354|144399900|SUPERIORITY||Mean Difference (Final Values)|0.24||||0.0734|TWO_SIDED|95.0|-0.02|0.5|||Mixed Models Analysis||Placebo SLIT-tablet vs. tree SLIT-tablet|Multiple imputation was used to impute missing data under the hypothetical strategy. The square root transformed endpoint was analysed in a linear mixed effects (LME) model with treatment, cohort, and age group as fixed effects, and pollen station within cohort as a random effect with different residual errors specified for each treatment group. Back-transformation was used to estimate the absolute difference. Adjusted p-value.||0.50|-0.02|0.0734
72443306|NCT04878354|144399901|SUPERIORITY||Mean Difference (Final Values)|0.86|||<|0.0001|TWO_SIDED|95.0|0.45|1.28|||Mixed Models Analysis||Placebo SLIT-tablet vs. tree SLIT-tablet|Multiple imputation was used to impute missing data under the hypothetical strategy. The square root transformed endpoint was analysed in a linear mixed effects (LME) model with treatment, cohort, and age group as fixed effects, and pollen station within cohort as a random effect with different residual errors specified for each treatment group. Back-transformation was used to estimate the absolute difference. Observed p-value.||1.28|0.45|<0.0001
72443307|NCT04878354|144399902|SUPERIORITY||Mean Difference (Final Values)|0.54||||0.0002|TWO_SIDED|95.0|0.26|0.82|||Mixed Models Analysis||Placebo SLIT-tablet vs. tree SLIT-tablet|Multiple imputation was used to impute missing data under the hypothetical strategy. The square root transformed endpoint was analysed in a linear mixed effects (LME) model with treatment, cohort, and age group as fixed effects, and pollen station within cohort as a random effect with different residual errors specified for each treatment group. Back-transformation was used to estimate the absolute difference. Observed p-value.||0.82|0.26|0.0002
72443308|NCT04878354|144399903|SUPERIORITY||Mean Difference (Final Values)|0.32||||0.1516|TWO_SIDED|95.0|-0.11|0.76|||Mixed Models Analysis||Placebo SLIT-tablet vs. tree SLIT-tablet|Multiple imputation was used to impute missing data under the hypothetical strategy. The square root transformed endpoint was analysed in a linear mixed effects (LME) model with treatment, cohort, and age group as fixed effects, and pollen station within cohort as a random effect with different residual errors specified for each treatment group. Back-transformation was used to estimate the absolute difference. Observed p-value.||0.76|-0.11|0.1516
72560035|NCT01139762|144650643|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.32|||<|0.001|TWO_SIDED|95.0|-0.5|-0.14||P-value is for 4 weeks.|Mixed Model Repeated Measures Analysis|The Kenward-Roger approximation was used to estimate denominator degrees of freedom.||MMRM model includes treatment, region, visit, and treatment-by-visit interaction as fixed effects, and subject as a random effect. Baseline total IPSS was the covariate. No imputation of missing total IPSS data was performed. The within-subject errors were modeled using an unstructured covariance structure.||-0.14|-0.50|<0.001
72560036|NCT01139762|144650643|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.19||||0.051|TWO_SIDED|95.0|-0.38|0.0||P-value is for 12 weeks.|Mixed Model Repeated Measures Analysis|The Kenward-Roger approximation was used to estimate denominator degrees of freedom.||MMRM model includes treatment, region, visit, and treatment-by-visit interaction as fixed effects, and subject as a random effect. Baseline total IPSS was the covariate. No imputation of missing total IPSS data was performed. The within-subject errors were modeled using an unstructured covariance structure.||0.00|-0.38|0.051
72622372|NCT05524948|144774642|OTHER||Adjusted Mean Difference|-396.96|STANDARD_ERROR_OF_MEAN|95.541|<|0.0001|TWO_SIDED|95.0|-586.51|-207.41|||ANCOVA|Analysis was performed using ANCOVA model with study product and gender as a factor and baseline concentration as a covariate.||||-207.41|-586.51|<0.0001
72388631|NCT03298867|144285590|SUPERIORITY||Stratified difference in percentages|36.03|STANDARD_ERROR_OF_MEAN|9.51|<|0.001|TWO_SIDED|95.0|17.39|54.67||Two-sided p-value calculated assuming the test statistic was distributed as a standard normal random variable.|Cochran-Mantel-Haenszel||Stratified difference (teprotumumab - placebo) is a weighted average of the difference within each stratum. Estimates from the 2 strata (tobacco user, tobacco non-user) were combined with CMH weights.|||54.67|17.39|<0.001
72443309|NCT04878354|144399904|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.9709|TWO_SIDED|95.0|-0.24|0.25|||Mixed Models Analysis||Placebo SLIT-tablet vs. tree SLIT-tablet|Multiple imputation was used to impute missing data under the hypothetical strategy. The square root transformed endpoint was analysed in a linear mixed effects (LME) model with treatment, cohort, and age group as fixed effects, and pollen station within cohort as a random effect with different residual errors specified for each treatment group. Back-transformation was used to estimate the absolute difference. Observed p-value.||0.25|-0.24|0.9709
72560037|NCT01139762|144650643|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.17||||0.107|TWO_SIDED|95.0|-0.38|0.04||P-value is for 26 weeks.|Mixed Model Repeated Measures Analysis|The Kenward-Roger approximation was used to estimate denominator degrees of freedom.||MMRM model includes treatment, region, visit, and treatment-by-visit interaction as fixed effects, and subject as a random effect. Baseline total IPSS was the covariate. No imputation of missing total IPSS data was performed. The within-subject errors were modeled using an unstructured covariance structure.||0.04|-0.38|0.107
72560038|NCT01139762|144650644|SUPERIORITY_OR_OTHER||LS Mean Difference|4.85|||<|0.001|TWO_SIDED|95.0|3.49|6.21||P-value is for 4 weeks.|Mixed Model Repeated Measures Analysis|The Kenward-Roger approximation was used to estimate denominator degrees of freedom.||MMRM model includes treatment, region, visit, and treatment-by-visit interaction as fixed effects, and subject as a random effect. Baseline IIEF was the covariate. No imputation of missing IIEF data was performed. The within-subject errors were modeled using an unstructured covariance structure.||6.21|3.49|<0.001
72443310|NCT04878354|144399905|SUPERIORITY||Mean Difference (Final Values)|0.21||||0.0499|TWO_SIDED|95.0|0.0|0.41|||Mixed Models Analysis||Placebo SLIT-tablet vs. tree SLIT-tablet|Multiple imputation was used to impute missing data under the hypothetical strategy. The square root transformed endpoint was analysed in a linear mixed effects (LME) model with treatment, cohort, and age group as fixed effects, and pollen station within cohort as a random effect with different residual errors specified for each treatment group. Back-transformation was used to estimate the absolute difference. Observed p-value.||0.41|0.00|0.0499
72443311|NCT04878354|144399906|SUPERIORITY||Median Difference (Final Values)|1.45|||<|0.0001|TWO_SIDED|95.0|0.73|2.18|||Mixed Models Analysis||Placebo SLIT-tablet vs. tree SLIT-tablet|Multiple imputation was used to impute missing data under the hypothetical strategy. The square root transformed endpoint was analysed in a linear mixed effects (LME) model with treatment, cohort, and age group as fixed effects, and pollen station within cohort as a random effect with different residual errors specified for each treatment group. Back-transformation was used to estimate the absolute difference. Observed p-value.||2.18|0.73|<0.0001
72443312|NCT04878354|144399907|SUPERIORITY||Median Difference (Final Values)|0.48||||0.0075|TWO_SIDED|95.0|0.13|0.83|||Mixed Models Analysis||Placebo SLIT-tablet vs. tree SLIT-tablet|Multiple imputation was used to impute missing data under the hypothetical strategy. The square root transformed endpoint was analysed in a linear mixed effects (LME) model with treatment, cohort, and age group as fixed effects, and pollen station within cohort as a random effect with different residual errors specified for each treatment group. Back-transformation was used to estimate the absolute difference. Observed p-value.||0.83|0.13|0.0075
72443313|NCT04878354|144399908|SUPERIORITY||Median Difference (Final Values)|0.87|||<|0.0001|TWO_SIDED|95.0|0.44|1.29|||Mixed Models Analysis||Placebo SLIT-tablet vs. tree SLIT-tablet|Multiple imputation was used to impute missing data under the hypothetical strategy. The square root transformed endpoint was analysed in a linear mixed effects (LME) model with treatment, cohort, and age group as fixed effects, and pollen station within cohort as a random effect with different residual errors specified for each treatment group. Back-transformation was used to estimate the absolute difference. Observed p-value.||1.29|0.44|<0.0001
72443314|NCT04878354|144399909|SUPERIORITY||Odds Ratio (OR)|1.2|||<|0.0001|TWO_SIDED|95.0|1.1|1.32|||Generalised linear mixed model (GLMM)||Odds ratio is (odds placebo SLIT-tablet / odds tree SLIT-tablet)|The odds of having a severe day was analysed using a generalised linear mixed model (GLMM) with a logit link function. The model includes proportion of severe days as the response variable and treatment, cohort, and age group as fixed effects and pollen station as random effect. Observed p-value.||1.32|1.10|<0.0001
72443315|NCT04878354|144399910|SUPERIORITY||Odds Ratio (OR)|1.0||||0.9124|TWO_SIDED|95.0|0.93|1.08|||Generalised linear mixed model (GLMM)||Odds ration is (odds placebo SLIT-tablet / odds tree SLIT-tablet)|The odds of having a severe day was analysed using a generalised linear mixed model (GLMM) with a logit link function. The model includes proportion of severe days as the response variable and treatment, cohort, and age group as fixed effects and pollen station as random effect. Observed p-value.||1.08|0.93|0.9124
72443316|NCT04878354|144399911|SUPERIORITY||Odds Ratio (OR)|0.76|||<|0.0001|TWO_SIDED|95.0|0.71|0.81|||Generalised linear fixed model (GLMM)||Odds ratio is (odds placebo SLIT-tablet / odds tree SLIT-tablet)|The odds of having a well day was analysed using a generalised linear mixed model (GLMM) with a logit link function. The model includes proportion of well days as the response variable and treatment, cohort, and age group as fixed effects and pollen station as random effect. Observed p-value.||0.81|0.71|<0.0001
72443317|NCT04878354|144399912|SUPERIORITY||Odds Ratio (OR)|0.89|||<|0.0001|TWO_SIDED|95.0|0.85|0.93|||Generalised linear mixed model (GLMM)||Odds ratio is (odds placebo SLIT-tablet / odds tree SLIT-tablet)|The odds of having a well day was analysed using a generalised linear mixed model (GLMM) with a logit link function. The model includes proportion of well days as the response variable and treatment, cohort, and age group as fixed effects and pollen station as random effect. Observed p-value.||0.93|0.85|<0.0001
72443318|NCT04878354|144399913|SUPERIORITY||Odds Ratio (OR)|0.78|||<|0.0001|TWO_SIDED|95.0|0.72|0.84|||Generalised linear mixed model (GLMM)||Odds ratio is (odds placebo SLIT-tablet / odds tree SLIT-tablet)|The odds of having a symptom-free day was analysed using a generalised linear mixed model (GLMM) with a logit link function. The model includes proportion of symptom-free days as the response variable and treatment, cohort, and age group as fixed effects and pollen station as random effect. Observed p-value.||0.84|0.72|<0.0001
72496817|NCT04187092|144523084|SUPERIORITY||||||<|0.05|||||||ANCOVA|||The 12-week changes in the KOOS scores, and the 12-week changes in the IKDC scores were analyzed by way of analysis of covariance (ANCOVA). Covariates: Age and sex of the subject, the subject's baseline outcome measure, the subject's baseline IKDC Total score, and the subject's standardized intake date (i.e., i.e., subject's intake date minus the intake date of the first enrolled subject) served as the ANCOVA concomitant adjustment variables||||<0.05
72496818|NCT03242954|144523129|SUPERIORITY||Cohen's f square|0.011|STANDARD_ERROR_OF_MEAN|0.208||0.5148|TWO_SIDED|95.0|0.001|0.101|||Regression, Linear|||||0.101|0.001|0.5148
72560039|NCT01139762|144650644|SUPERIORITY_OR_OTHER||LS Mean Difference|4.08|||<|0.001|TWO_SIDED|95.0|2.55|5.6||P-value is for 12 weeks.|Mixed Model Repeated Measures Analysis|The Kenward-Roger approximation was used to estimate denominator degrees of freedom.||MMRM model includes treatment, region, visit, and treatment-by-visit interaction as fixed effects, and subject as a random effect. Baseline IIEF was the covariate. No imputation of missing IIEF data was performed. The within-subject errors were modeled using an unstructured covariance structure.||5.60|2.55|<0.001
72619162|NCT03016403|144769030|SUPERIORITY||Mean Difference (Final Values)|1.46||||0.0243|TWO_SIDED|95.0|0.19|2.73||Since there are three primary outcomes (depression, anxiety and coping scores) in the study, the significance level was set a priori at 0.0167 (alpha = 0.05/3).|Mixed Models Analysis|The pvalue corresponds to the hypothesis of the interaction effect between time and group (intervention arm).|The estimate represents the difference in expected means at the 6-month time point between the intervention and usual care arms.|Linear mixed models (LMM) have been used with time and the interaction between time and group as fixed effects. A structure of random effects that includes random intercepts for patients was used. The study was powered for testing the hypothesis of no group differences in change over the four time points. A significant group by time interaction was hypothesized.||2.73|0.19|0.0243
72622373|NCT05524948|144774643|OTHER||Adjusted Mean Difference|-341.37|STANDARD_ERROR_OF_MEAN|72.446|<|0.0001|TWO_SIDED|95.0|-485.1|-197.64|||ANCOVA|Analysis was performed using ANCOVA model with study product and gender as a factor and baseline concentration as a covariate.|For Hydrogen Sulfide|||-197.64|-485.10|<0.0001
72443319|NCT04878354|144399914|SUPERIORITY||Odds Ratio (OR)|0.9||||0.0001|TWO_SIDED|95.0|0.86|0.95|||Generalised linear mixed model (GLMM)||Odds ratio is (odds placebo SLIT-tablet / odds tree SLIT-tablet)|The odds of having a symptom-free day was analysed using a generalised linear mixed model (GLMM) with a logit link function. The model includes proportion of symptom-free days as the response variable and treatment, cohort, and age group as fixed effects and pollen station as random effect. Observed p-value.||0.95|0.86|0.0001
72560040|NCT01139762|144650644|SUPERIORITY_OR_OTHER||LS Mean Difference|4.73|||<|0.001|TWO_SIDED|95.0|3.15|6.31||P-value is for 26 weeks.|Mixed Model Repeated Measures Analysis|The Kenward-Roger approximation was used to estimate denominator degrees of freedom.||MMRM model includes treatment, region, visit, and treatment-by-visit interaction as fixed effects, and subject as a random effect. Baseline IIEF was the covariate. No imputation of missing IIEF data was performed. The within-subject errors were modeled using an unstructured covariance structure.||6.31|3.15|<0.001
72443320|NCT04878354|144399917|SUPERIORITY||Mean Difference (Final Values)|0.18||||0.0015|TWO_SIDED|95.0|0.07|0.29|||Mixed Models Analysis||Placebo SLIT-tablet vs tree SLIT-tablet|Multiple imputation was used to impute missing data under the hypothetical strategy. The square root transformed endpoint was analysed in an LME model with treatment, cohort, and age group as fixed effects, and pollen station within cohort as a random effect with different residual errors specified for each treatment group. Back-transformation was used to estimate the absolute difference. Observed p-value.||0.29|0.07|0.0015
72443321|NCT04878354|144399918|SUPERIORITY||Mean Difference (Final Values)|0.12||||0.0032|TWO_SIDED|95.0|0.04|0.2|||Mixed Models Analysis||Placebo SLIT-tablet vs tree SLIT-tablet|Multiple imputation was used to impute missing data under the hypothetical strategy. The square root transformed endpoint was analysed in a linear mixed effects (LME) model with treatment, cohort, and age group as fixed effects, and pollen station within cohort as a random effect with different residual errors specified for each treatment group. Back-transformation was used to estimate the absolute difference. Observed p-value.||0.20|0.04|0.0032
72496819|NCT03242954|144523130|SUPERIORITY||Cohen's f square|0.306|STANDARD_ERROR_OF_MEAN|0.149|<|0.0001|TWO_SIDED|95.0|0.169|0.389|||Regression, Linear|||||0.389|0.169|<.0001
72560041|NCT01139762|144650645|SUPERIORITY_OR_OTHER||LS Mean Difference|1.01|||<|0.001|TWO_SIDED|95.0|0.61|1.4||P-value is for 4 weeks.|Mixed Model Repeated Measures Analysis|The Kenward-Roger approximation was used to estimate denominator degrees of freedom.||MMRM model includes treatment, region, visit, and treatment-by-visit interaction as fixed effects, and subject as a random effect. Baseline IIEF was the covariate. No imputation of missing IIEF data was performed. The within-subject errors were modeled using an unstructured covariance structure.||1.40|0.61|<0.001
72560042|NCT01139762|144650645|SUPERIORITY_OR_OTHER||LS Mean Difference|1.06|||<|0.001|TWO_SIDED|95.0|0.61|1.51||P-value is for 12 weeks.|Mixed Model Repeated Measures Analysis|The Kenward-Roger approximation was used to estimate denominator degrees of freedom.||MMRM model includes treatment, region, visit, and treatment-by-visit interaction as fixed effects, and subject as a random effect. Baseline IIEF was the covariate. No imputation of missing IIEF data was performed. The within-subject errors were modeled using an unstructured covariance structure.||1.51|0.61|<0.001
72560043|NCT01139762|144650645|SUPERIORITY_OR_OTHER||LS Mean Difference|1.22|||<|0.001|TWO_SIDED|95.0|0.74|1.69||P-value is for 26 weeks.|Mixed Model Repeated Measures Analysis|The Kenward-Roger approximation was used to estimate denominator degrees of freedom.||MMRM model includes treatment, region, visit, and treatment-by-visit interaction as fixed effects, and subject as a random effect. Baseline IIEF was the covariate. No imputation of missing IIEF data was performed. The within-subject errors were modeled using an unstructured covariance structure.||1.69|0.74|<0.001
72388632|NCT03298867|144285591|SUPERIORITY||LS mean difference|-2.28|STANDARD_ERROR_OF_MEAN|0.244|<|0.001|TWO_SIDED|95.0|-2.77|-1.8||Results obtained from an MMRM with an unstructured covariance matrix including the following terms: Baseline value, tobacco use status, treatment group, visit, visit-by-treatment interaction and visit-by-Baseline-value interaction.|mixed model for repeated measures (MMRM)|||||-1.80|-2.77|<0.001
72388633|NCT03298867|144285592|SUPERIORITY||Stratified difference in percentages|39.29|STANDARD_ERROR_OF_MEAN|12.11||0.001|TWO_SIDED|95.0|15.55|63.02||Two-sided p-value calculated assuming the test statistic was distributed as a standard normal random variable.|Cochran-Mantel-Haenszel||Stratified difference is a weighted average of the difference within each stratum. Estimates from the 2 strata (tobacco user, tobacco non-user) were combined with CMH weights.|||63.02|15.55|0.001
72388634|NCT03298867|144285593|SUPERIORITY||Difference in LS mean|9.36|STANDARD_ERROR_OF_MEAN|2.651|<|0.001|TWO_SIDED|95.0|4.08|14.64||Results obtained from an MMRM with an unstructured covariance matrix including the following terms: Baseline value, tobacco use status, treatment group, visit, visit-by-treatment interaction and visit-by-Baseline-value interaction.|mixed model for repeated measures (MMRM)|||||14.64|4.08|<0.001
72388635|NCT04560998|144285596|SUPERIORITY||The Hodges-Lehmann estimate|1.13||||0.0004|TWO_SIDED|95.0|1.056|1.211|||Wilcoxon (Mann-Whitney)|||||1.211|1.056|0.0004
72388636|NCT04560998|144285597|SUPERIORITY||The Hodges-Lehmann estimate|1.08||||0.038|TWO_SIDED|95.0|1.004|1.156|||Wilcoxon (Mann-Whitney)|||||1.156|1.004|0.0380
72388637|NCT04560998|144285598|SUPERIORITY||The Hodges-Lehmann estimate|1.0||||0.0108|TWO_SIDED|95.0|0.478|1.518|||Wilcoxon (Mann-Whitney)|||||1.518|0.478|0.0108
72388638|NCT04560998|144285599|SUPERIORITY||The Hodges-Lehmann Estimate|1.11||||0.0046|TWO_SIDED|95.0|1.033|1.197|||Wilcoxon (Mann-Whitney)|||||1.197|1.033|0.0046
72388639|NCT04678661|144285616|SUPERIORITY|||||||0.207||||||Propensity score matching was used to form pairs of intervention and control participants. Specifically, a greedy matching procedure with a matching caliper of 0.2 of the standard deviation of the logit of the propensity score was used.|Regression, Linear|Model adjusted for covariates of age, race, baseline BMI, and baseline hemoglobin A1c.||||||.207
72388640|NCT04678661|144285617|OTHER|||||||0.011|||||||t-test, 2 sided|||Independent t-test||||.011
72388641|NCT04678661|144285618|OTHER|||||||0.024|||||||t-test, 2 sided|||||||.024
72388642|NCT04678661|144285619|OTHER|||||||0.579|||||||t-test, 2 sided|||||||.579
72388643|NCT04678661|144285620|OTHER||||||<|0.001||||||Reported p-value was calculated.|t-test, 2 sided|||||||<.001
72388644|NCT04678661|144285621|OTHER|||||||0.269|||||||t-test, 2 sided|||||||.269
72388645|NCT04678661|144285624|OTHER||||||<|0.001||||||Reported p-value was calculated.|t-test, 2 sided|||||||<.001
72388646|NCT04678661|144285625|OTHER||||||<|0.001||||||Reported p-value was calculated.|t-test, 2 sided|||||||<.001
72388647|NCT04678661|144285626|OTHER|||||||0.647|||||||t-test, 2 sided|||||||.647
72496820|NCT03242954|144523131|SUPERIORITY||Cohen's f square|0.008|STANDARD_ERROR_OF_MEAN|0.213||0.4324|TWO_SIDED|95.0|0.001|0.073|||GEE Linear model|||||0.073|0.001|0.4324
72496821|NCT03242954|144523132|SUPERIORITY||Cohen's f square|0.26|STANDARD_ERROR_OF_MEAN|0.149|<|0.0001|TWO_SIDED|95.0|0.175|0.374|||GEE Linear model|||||0.374|0.175|<.0001
72496822|NCT00925600|144523134|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was demonstrated if the upper bound of the 97.5% one-sided confidence interval, or equivalently upper bound of two-sided 95% confidence interval was less than the pre-specified non-inferiority bound of 10%.|Risk Difference (RD)|0.4|STANDARD_ERROR_OF_MEAN|3.4||0.0026|TWO_SIDED|95.0|-6.3|7.2|||Mantel Haenszel|||The primary endpoint was summarized with the point estimate of absolute risk difference (difference in incidence rates, denosumab minus placebo) and the corresponding 95% confidence interval using the Mantel-Haenszel method adjusting for the stratification factors: baseline LOCS III status (\< 3.0 at all sites \[P, C, and NO\] vs. ≥ 3.0 at any of these sites), age group (\< 75, ≥ 75 years), and patient-reported history of cataract (yes/no).||7.2|-6.3|0.0026
72496823|NCT00925600|144523135|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-2.2|STANDARD_ERROR_OF_MEAN|2.1|||TWO_SIDED|95.0|-6.4|2.0||||||The point estimate of absolute risk difference (difference in incidence rates, denosumab minus placebo) and the corresponding 95% confidence interval was constructed using the Mantel-Haenszel method adjusting for the stratification factors: baseline LOCS III status (\< 3.0 at all sites \[P, C, and NO\] vs. ≥ 3.0 at any of these sites), age group (\< 75, ≥ 75 years), and patient-reported history of cataract (yes/no).||2.0|-6.4|
72496824|NCT00925600|144523136|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.3|STANDARD_ERROR_OF_MEAN|2.9|||TWO_SIDED|95.0|-5.9|5.3||||||The point estimate of absolute risk difference (difference in incidence rates, denosumab minus placebo) and the corresponding 95% confidence interval was constructed using the Mantel-Haenszel method adjusting for the stratification factors: baseline LOCS III status (\< 3.0 at all sites \[P, C, and NO\] vs. ≥ 3.0 at any of these sites), age group (\< 75, ≥ 75 years), and patient-reported history of cataract (yes/no).||5.3|-5.9|
72496825|NCT00925600|144523137|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-2.2|STANDARD_ERROR_OF_MEAN|2.8|||TWO_SIDED|95.0|-7.6|3.3||||||The point estimate of absolute risk difference (difference in incidence rates, denosumab minus placebo) and the corresponding 95% confidence interval was constructed using the Mantel-Haenszel method adjusting for the stratification factors: baseline LOCS III status (\< 3.0 at all sites \[P, C, and NO\] vs. ≥ 3.0 at any of these sites), age group (\< 75, ≥ 75 years), and patient-reported history of cataract (yes/no).||3.3|-7.6|
72443322|NCT04878354|144399919|SUPERIORITY||Mean Difference (Final Values)|0.01||||0.9277|TWO_SIDED|95.0|-0.21|0.23|||Mixed Models Analysis||Placebo SLIT-tablet vs tree SLIT-tablet|Multiple imputation was used to impute missing data under the hypothetical strategy. The endpoint was analysed in each dataset in a linear mixed effects (LME) model with treatment and cohort as fixed effects, and pollen station within cohort as a random effect. Each treatment group was allowed different residual errors. Observed p-value.||0.23|-0.21|0.9277
72443323|NCT04878354|144399920|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.9643|TWO_SIDED|95.0|-0.19|0.18|||Mixed Models Analysis||Placebo SLIT-tablet vs tree SLIT-tablet|Multiple imputation was used to impute missing data under the hypothetical strategy. The endpoint was analysed in each dataset in a linear mixed effect (LME) model with treatment and cohort as fixed effects, and pollen station within cohort as a random effect. Each treatment group was allowed different residual errors. Observed p-value.||0.18|-0.19|0.9643
72504663|NCT02495077|144540088|SUPERIORITY||Mean Difference (Final Values)|-2.09||||0.411|TWO_SIDED|95.0|-7.08|2.91|||Mixed Models Analysis|||Day 180. Mean eGFR of the two treatment groups was compared. The p-value, estimated day 180 eGFR within each treatment group, estimate of the treatment group difference, and estimated 95% confidence interval result from a repeated measures mixed model using available eGFR data from months 1, 3, 6, 12, 18, and 24 to compare the experimental group to the control group at day 180. Random effects for the intercept and eGFR collection day were utilized in the model.||2.91|-7.08|0.411
72504664|NCT02495077|144540089|SUPERIORITY|||||||0.569|||||||Chi-squared|||||||0.569
72504665|NCT02495077|144540090|SUPERIORITY||||||>|0.999|||||||Fisher Exact|||||||>0.999
72504666|NCT02495077|144540091|SUPERIORITY|||||||0.451|||||||Chi-squared|||||||0.451
72504667|NCT02495077|144540092|SUPERIORITY|||||||0.614|||||||t-test, 2 sided|||||||0.614
72504668|NCT02495077|144540093|SUPERIORITY|||||||0.71|||||||t-test, 2 sided|||||||0.710
72504669|NCT02495077|144540094|SUPERIORITY|||||||0.622|||||||Fisher Exact|||||||0.622
72504670|NCT02495077|144540095|SUPERIORITY||Mean Difference (Final Values)|0.49||||0.256|TWO_SIDED|95.0|-0.36|1.35|||Mixed Models Analysis|||24 Hours/Day 1. Mean serum creatinine of the two treatment groups was compared. The p-value, estimated 24 hour creatinine level within each treatment group, estimate of the treatment group difference, and estimated 95% confidence interval result from a repeated measures mixed model using available serum creatinine data from 24, 48, and 72 hours to compare the experimental group to the control group at 24 hours/day 1. A random effect for the intercept was utilized in the model.||1.35|-0.36|0.256
72504671|NCT02495077|144540095|SUPERIORITY||Mean Difference (Final Values)|0.37||||0.391|TWO_SIDED|95.0|-0.48|1.23|||Mixed Models Analysis|||48 Hours/Day 2. Mean serum creatinine of the two treatment groups was compared. The p-value, estimated 48 hour creatinine level within each treatment group, estimate of the treatment group difference, and estimated 95% confidence interval result from a repeated measures mixed model using available serum creatinine data from 24, 48, and 72 hours to compare the experimental group to the control group at 48 hours/day 2. A random effect for the intercept was utilized in the model.||1.23|-0.48|0.391
72504672|NCT02495077|144540095|SUPERIORITY||Mean Difference (Final Values)|0.56||||0.199|TWO_SIDED|95.0|-0.3|1.42|||Mixed Models Analysis|||72 Hours/Day 3. Mean serum creatinine of the two treatment groups was compared. The p-value, estimated 72 hour creatinine level within each treatment group, estimate of the treatment group difference, and estimated 95% confidence interval result from a repeated measures mixed model using available serum creatinine data from 24, 48, and 72 hours to compare the experimental group to the control group at 72 hours/day 3. A random effect for the intercept was utilized in the model.||1.42|-0.30|0.199
72504673|NCT02495077|144540096|SUPERIORITY|||||||0.812|||||||Log Rank|||||||0.812
72504674|NCT02495077|144540097|SUPERIORITY|||||||0.576|||||||Chi-squared|||||||0.576
72504675|NCT02495077|144540098|SUPERIORITY|||||||0.311|||||||t-test, 2 sided|||||||0.311
72504676|NCT02495077|144540099|SUPERIORITY|||||||0.418|||||||t-test, 2 sided|||||||0.418
72504677|NCT02495077|144540100|SUPERIORITY|||||||0.03|||||||Chi-squared|||||||0.030
72443324|NCT04878354|144399921|SUPERIORITY||Mean Difference (Final Values)|0.18||||0.0287|TWO_SIDED|95.0|0.02|0.34|||Mixed Models Analysis||Placebo SLIT-tablet vs. tree SLIT-tablet|Multiple imputation was used to impute missing data under the hypothetical strategy. The endpoint was analysed in each dataset in a linear mixed effect (LME) model with treatment and cohort as fixed effects, and pollen station within cohort as a random effect. Each treatment group was allowed different residual errors. Observed p-value.||0.34|0.02|0.0287
72496826|NCT05512949|144523169|NON_INFERIORITY|The ID-dose regimen is considered non-inferior if the lower bound of the confidence interval (original scale) is no less than half that of the standard dose, giving a NI margin of 0.5 (NI= -0.301 log10 scale).|Geometric mean titer ratio (GMTR)|0.7||||0.045|TWO_SIDED|95.0|0.5|1.0||Significance can be considered if P \<0.05. Not adjusted for multiple comparisons.|t-test, 2 sided|Two-sample t-test with unequal variance, noninferiority (NI) margin of 0.5 and two-sided type I error rate of 0.05.||The selection of the noninferiority (NI) margin was based on the pivotal Phase 3 trial by Pittman et al., in 2019 comparing one dose of ACAM2000 and the now licensed 2-dose standard MVA-BN regimen, which provided an estimated relative (peak) immune response of approximately 2-times higher for MVA-BN. An NI margin of 0.5 corresponds to an immune response of the lower-dose MVA-BN at least as high as what would be expected for ACAM2000.||1.0|0.5|0.045
72496827|NCT05512949|144523169|NON_INFERIORITY|The ID-dose regimen is considered non-inferior if the lower bound of the confidence interval (original scale) is no less than half that of the standard dose, giving a NI margin of 0.5 (NI= -0.301 log10 scale).|Geometric mean titer ratio (GMTR)|0.4||||0.162|TWO_SIDED|95.0|0.3|0.6||Significance can be considered if P \<0.05. Not adjusted for multiple comparisons.|t-test, 2 sided|Two-sample t-test with unequal variance, noninferiority (NI) margin of 0.5 and two-sided type I error rate of 0.05.||The selection of the noninferiority (NI) margin was based on the pivotal Phase 3 trial by Pittman et al., in 2019 comparing one dose of ACAM2000 and the now licensed 2-dose standard MVA-BN regimen, which provided an estimated relative (peak) immune response of approximately 2-times higher for MVA-BN. An NI margin of 0.5 corresponds to an immune response of the lower-dose MVA-BN at least as high as what would be expected for ACAM2000.||0.6|0.3|0.162
72496828|NCT05512949|144523172|SUPERIORITY|||||||0.888|||||||Wilcoxon (Mann-Whitney)|||||||0.888
72496829|NCT05512949|144523172|SUPERIORITY|||||||0.708|||||||Wilcoxon (Mann-Whitney)|||||||0.708
72496830|NCT04660643|144523189|SUPERIORITY||LS Mean difference|-21.4|||<|0.001|TWO_SIDED|95.0|-22.9|-20.0|||Mixed Models Analysis|||||-20.0|-22.9|<.001
72496831|NCT04660643|144523190|SUPERIORITY||LS Mean difference|-15.9|||<|0.001|TWO_SIDED|95.0|-17.0|-14.9|||Mixed Models Analysis|||||-14.9|-17.0|<.001
72496832|NCT04660643|144523191|SUPERIORITY||LS Mean difference|-17.6|||<|0.001|TWO_SIDED|95.0|-18.8|-16.4|||Mixed Models Analysis|||||-16.4|-18.8|<.001
72560044|NCT01139762|144650646|SUPERIORITY_OR_OTHER||LS Mean Difference|1.82|||<|0.001|TWO_SIDED|95.0|1.18|2.47||P-value is for 4 weeks.|Mixed Model Repeated Measures Analysis|The Kenward-Roger approximation was used to estimate denominator degrees of freedom.||MMRM model includes treatment, region, visit, and treatment-by-visit interaction as fixed effects, and subject as a random effect. Baseline IIEF was the covariate. No imputation of missing IIEF data was performed. The within-subject errors were modeled using an unstructured covariance structure.||2.47|1.18|<0.001
72560045|NCT01139762|144650646|SUPERIORITY_OR_OTHER||LS Mean Difference|1.59|||<|0.001|TWO_SIDED|95.0|0.88|2.31||P-value is for 12 weeks.|Mixed Model Repeated Measures Analysis|The Kenward-Roger approximation was used to estimate denominator degrees of freedom.||MMRM model includes treatment, region, visit, and treatment-by-visit interaction as fixed effects, and subject as a random effect. Baseline IIEF was the covariate. No imputation of missing IIEF data was performed. The within-subject errors were modeled using an unstructured covariance structure.||2.31|0.88|<0.001
72622374|NCT05524948|144774643|OTHER||Adjusted Mean Difference|-74.15|STANDARD_ERROR_OF_MEAN|20.905||0.0006|TWO_SIDED|95.0|-115.62|-32.68|||ANCOVA|Analysis was performed using ANCOVA model with study product and gender as a factor and baseline concentration as a covariate.|For Methanethiol|||-32.68|-115.62|0.0006
72443325|NCT04878354|144399923|SUPERIORITY||Odds Ratio (OR)|0.42|||<|0.0001|TWO_SIDED|95.0|0.3|0.58|||Generalized linear mixed model (GLMM)||Odds ratio is (odds placebo SLIT-tablet/ odds tree SLIT-tablet)|"Multiple imputation was used to impute missing data under the hypothetical strategy.~The odds of having an improved treatment efficacy according to patient-rated global evaluation was analysed using a generalised linear mixed model with a logit link function. The model includes patient-rated global evaluation of treatment efficacy (improvement/no improvement) as the response variable and treatment, cohort and age group as fixed effects and pollen station as random effects. Observed p-value."||0.58|0.30|<0.0001
72496833|NCT04660643|144523192|SUPERIORITY||LS Mean difference|-12.9|||<|0.001|TWO_SIDED|95.0|-14.1|-11.7|||Mixed Models Analysis|||||-11.7|-14.1|<.001
72496834|NCT04660643|144523193|SUPERIORITY||LS Mean difference|-6.4|||<|0.001|TWO_SIDED|95.0|-6.8|-6.0|||Mixed Models Analysis|||||-6.0|-6.8|<.001
72496835|NCT04660643|144523194|SUPERIORITY||LS Mean difference|-8.64|||<|0.001|TWO_SIDED|95.0|-10.14|-7.15|||Mixed Models Analysis|||||-7.15|-10.14|<.001
72496836|NCT04660643|144523195|SUPERIORITY||LS Mean difference|-0.33|||<|0.001|TWO_SIDED|95.0|-0.38|-0.28|||Mixed Models Analysis|||||-0.28|-0.38|<.001
72496837|NCT04660643|144523196|SUPERIORITY||LS Mean difference|-31.4|STANDARD_ERROR_OF_MEAN|3.37|<|0.001|TWO_SIDED|95.0|-37.7|-24.4|||Mixed Models Analysis|||||-24.4|-37.7|<.001
72496838|NCT04660643|144523197|SUPERIORITY||LS Mean difference|-5.54|STANDARD_ERROR_OF_MEAN|1.139|<|0.001|TWO_SIDED|95.0|-7.76|-3.28|||Mixed Models Analysis|||Total Cholesterol||-3.28|-7.76|<.001
72496839|NCT04660643|144523197|SUPERIORITY||LS Mean difference|-6.57|STANDARD_ERROR_OF_MEAN|1.709|<|0.001|TWO_SIDED|95.0|-9.87|-3.15|||Mixed Models Analysis|||LDL Cholesterol||-3.15|-9.87|<.001
72496840|NCT04660643|144523197|SUPERIORITY||LS Mean difference|3.2|STANDARD_ERROR_OF_MEAN|1.33||0.014|TWO_SIDED|95.0|0.6|5.8|||Mixed Models Analysis|||HDL Cholesterol||5.8|0.6|0.014
72496841|NCT04660643|144523197|SUPERIORITY||LS Mean difference|-19.7|STANDARD_ERROR_OF_MEAN|2.25|<|0.001|TWO_SIDED|95.0|-24.0|-15.1|||Mixed Models Analysis|||VLDL Cholesterol||-15.1|-24.0|<.001
72622375|NCT05524948|144774643|OTHER||Adjusted Mean Difference|27.98|STANDARD_ERROR_OF_MEAN|25.942||0.2834|TWO_SIDED|95.0|-23.49|79.45|||ANCOVA|Analysis was performed using ANCOVA model with study product and gender as a factor and baseline concentration as a covariate.|For Dimethyl Sulfide|||79.45|-23.49|0.2834
72496842|NCT04660643|144523197|SUPERIORITY||LS Mean difference|-20.6|STANDARD_ERROR_OF_MEAN|2.27|<|0.001|TWO_SIDED|95.0|-24.9|-16.0|||Mixed Models Analysis|||Triglycerides||-16|-24.9|<.001
72560046|NCT01139762|144650646|SUPERIORITY_OR_OTHER||LS Mean Difference|1.98|||<|0.001|TWO_SIDED|95.0|1.23|2.73||P-value is for 26 weeks.|Mixed Model Repeated Measures Analysis|The Kenward-Roger approximation was used to estimate denominator degrees of freedom.||MMRM model includes treatment, region, visit, and treatment-by-visit interaction as fixed effects, and subject as a random effect. Baseline IIEF was the covariate. No imputation of missing IIEF data was performed. The within-subject errors were modeled using an unstructured covariance structure.||2.73|1.23|<0.001
72560047|NCT01139762|144650647|SUPERIORITY_OR_OTHER||LS Mean Difference|1.53|||<|0.001|TWO_SIDED|95.0|0.92|2.13||P-value is for 4 weeks.|Mixed Model Repeated Measures Analysis|The Kenward-Roger approximation was used to estimate denominator degrees of freedom.||MMRM model includes treatment, region, visit, and treatment-by-visit interaction as fixed effects, and subject as a random effect. Baseline IIEF was the covariate. No imputation of missing IIEF data was performed. The within-subject errors were modeled using an unstructured covariance structure.||2.13|0.92|<0.001
72443326|NCT04878354|144399924|SUPERIORITY||Mean Difference (Final Values)|0.43|||<|0.0001|TWO_SIDED|95.0|0.38|0.48|||Mixed Models Analysis||Tree SLIT-tablet vs placebo SLIT-tablet, visit 4|Change from baseline (screening) to visit 4 (pre-TPS). Change from baseline of log transformed concentrations is analyzed in a mixed effects linear model including treatment, visit, and treatment-visit-interaction as fixed effects, log(baseline concentration) as a covariate and subject as random effect. Observed p-value.||0.48|0.38|<0.0001
72443327|NCT04878354|144399924|SUPERIORITY||Mean Difference (Final Values)|-0.04||||0.1038|TWO_SIDED|95.0|-0.09|0.01|||Mixed Models Analysis||Tree SLIT-tablet vs. placebo SLIT-tablet, visit 6|Change from baseline (screening) to visit 6 (end of treatment). Change from baseline of log transformed concentrations is analysed in a mixed effects linear model including treatment, visit, and treatment-visit-interaction as fixed effects, log(baseline concentration) as a covariate and subject as random effect. Observed p-value.||0.01|-0.09|0.1038
72443328|NCT04878354|144399925|SUPERIORITY||Mean Difference (Final Values)|0.53|||<|0.0001|TWO_SIDED|95.0|0.48|0.57|||Mixed Models Analysis||Tree SLIT-tablet vs. placebo SLIT-tablet, visit 4|Change from baseline (screening) to visit 4 (pre-TPS). Change from baseline of log transformed concentrations is analysed in a mixed effects linear model including treatment, visit, and treatment-visit-interaction as fixed effects, log(baseline concentration) as a covariate and subject as random effect. Observed p-value.||0.57|0.48|<0.0001
72443329|NCT04878354|144399925|SUPERIORITY||Mean Difference (Final Values)|0.49|||<|0.0001|TWO_SIDED|95.0|0.45|0.53|||Mixed Models Analysis||Tree SLIT-tablet vs placebo SLIT-tablet, visit 6|Change from baseline (screening) to visit 6 (end of treatment). Change from baseline of log transformed concentrations is analysed in a mixed effects linear model including treatment, visit, and treatment-visit-interaction as fixed effects, log(baseline concentration) as a covariate and subject as random effect. Observed p-value.||0.53|0.45|<0.0001
72496843|NCT04660643|144523197|SUPERIORITY||LS Mean difference|-10.8|STANDARD_ERROR_OF_MEAN|3.79||0.008|TWO_SIDED|95.0|-17.9|-3.0|||Mixed Models Analysis|||FFA||-3.0|-17.9|0.008
72496844|NCT04660643|144523198|SUPERIORITY||LS Mean difference|-6.4|||<|0.001|TWO_SIDED|95.0|-8.1|-4.6|||Mixed Models Analysis|||SBP||-4.6|-8.1|<.001
72496845|NCT04660643|144523198|SUPERIORITY||LS Mean difference|-3.6|||<|0.001|TWO_SIDED|95.0|-4.8|-2.4|||Mixed Models Analysis|||DBP||-2.4|-4.8|<.001
72496846|NCT04660643|144523199|SUPERIORITY||LS Mean difference|2.6|||<|0.001|TWO_SIDED|95.0|1.7|3.5|||ANCOVA|||||3.5|1.7|<.001
72560048|NCT01139762|144650647|SUPERIORITY_OR_OTHER||LS Mean Difference|0.9||||0.006|TWO_SIDED|95.0|0.27|1.54||P-value is for 12 weeks.|Mixed Model Repeated Measures Analysis|The Kenward-Roger approximation was used to estimate denominator degrees of freedom.||MMRM model includes treatment, region, visit, and treatment-by-visit interaction as fixed effects, and subject as a random effect. Baseline IIEF was the covariate. No imputation of missing IIEF data was performed. The within-subject errors were modeled using an unstructured covariance structure.||1.54|0.27|0.006
72560049|NCT01139762|144650647|SUPERIORITY_OR_OTHER||LS Mean Difference|1.07||||0.002|TWO_SIDED|95.0|0.41|1.74||P-value is for 26 weeks.|Mixed Model Repeated Measures Analysis|The Kenward-Roger approximation was used to estimate denominator degrees of freedom.||MMRM model includes treatment, region, visit, and treatment-by-visit interaction as fixed effects, and subject as a random effect. Baseline IIEF was the covariate. No imputation of missing IIEF data was performed. The within-subject errors were modeled using an unstructured covariance structure.||1.74|0.41|0.002
72496847|NCT04660643|144523200|SUPERIORITY||LS Mean difference|9.4|||<|0.001|TWO_SIDED|95.0|6.8|12.0|||ANCOVA|||||12.0|6.8|<0.001
72496848|NCT04660643|144523201|SUPERIORITY||Odds Ratio (OR)|95.91|||<|0.001|TWO_SIDED|95.0|54.72|168.09|||Regression, Logistic|||||168.09|54.72|<0.001
72496849|NCT04660643|144523202|SUPERIORITY||Odds Ratio (OR)|47.27|||<|0.001|TWO_SIDED|95.0|18.32|121.99|||Regression, Logistic|||≥5% body weight reduction from baseline||121.99|18.32|<0.001
72496850|NCT04660643|144523202|SUPERIORITY||Odds Ratio (OR)|71.51|||<|0.001|TWO_SIDED|95.0|34.46|148.39|||Regression, Logistic|||≥10% body weight reduction from baseline||148.39|34.46|<0.001
72496851|NCT04660643|144523202|SUPERIORITY||Odds Ratio (OR)|79.99|||<|0.001|TWO_SIDED|95.0|42.06|152.14|||Regression, Logistic|||≥15% body weight reduction from baseline||152.14|42.06|<0.001
72496852|NCT04660643|144523202|SUPERIORITY||Odds Ratio (OR)|140.84|||<|0.001|TWO_SIDED|95.0|66.06|300.29|||Regression, Logistic|||≥20% body weight reduction from baseline||300.29|66.06|<0.001
72496853|NCT04660643|144523203|SUPERIORITY||Hazard Ratio (HR)|0.013|||<|0.001|TWO_SIDED|95.0|0.004|0.046|||Log Rank||Unstratified hazard ratio from Cox proportional hazard model with Baseline Weight (kg), Analysis Country, Sex, IWRS MTD at Week 36, Weight at randomization (kg) as covariates.|||0.046|0.004|<.001
72496854|NCT04660643|144523204|SUPERIORITY||LS Mean difference|-6.4|||<|0.001|TWO_SIDED|95.0|-6.8|-6.0|||Mixed Models Analysis|||||-6.0|-6.8|<.001
72496855|NCT04660643|144523205|SUPERIORITY||LS Mean difference|-17.6|||<|0.001|TWO_SIDED|95.0|-18.8|-16.4|||Mixed Models Analysis|||||-16.4|-18.8|<.001
72496856|NCT04660643|144523206|SUPERIORITY||LS Mean difference|-16.4|||<|0.001|TWO_SIDED|95.0|-17.5|-15.4|||Mixed Models Analysis|||||-15.4|-17.5|<.001
72496857|NCT04660643|144523207|SUPERIORITY||LS Mean difference|-13.6|||<|0.001|TWO_SIDED|95.0|-15.1|-12.2|||Mixed Models Analysis|||||-12.2|-15.1|<.001
72496858|NCT04660643|144523208|SUPERIORITY||LS Mean difference|-8.92|||<|0.001|TWO_SIDED|95.0|-10.4|-7.43|||Mixed Models Analysis|||||-7.43|-10.40|<.001
72496859|NCT04660643|144523209|SUPERIORITY||LS Mean difference|-0.34|||<|0.001|TWO_SIDED|95.0|-0.39|-0.29|||Mixed Models Analysis|||||-0.29|-0.39|<.001
72496860|NCT04660643|144523210|SUPERIORITY||LS Mean difference|-34.6|STANDARD_ERROR_OF_MEAN|3.25|<|0.001|TWO_SIDED|95.0|-40.6|-27.9|||Mixed Models Analysis|||||-27.9|-40.6|<.001
72496861|NCT04660643|144523211|SUPERIORITY||LS Mean difference|-7.02|STANDARD_ERROR_OF_MEAN|1.158|<|0.001|TWO_SIDED|95.0|-9.27|-4.72|||Mixed Models Analysis|||Total Cholesterol||-4.72|-9.27|<.001
72622376|NCT05524948|144774644|OTHER||Adjusted Mean Difference|-1.55|STANDARD_ERROR_OF_MEAN|0.138|<|0.0001|TWO_SIDED|95.0|-1.83|-1.28|||ANCOVA|Analysis was performed using ANCOVA model with study product and gender as a factor and Baseline overall breath organoleptic score as a covariate.|Adjusted mean difference was calculated as the experimental dentifrice minus the reference dentifrice.|||-1.28|-1.83|<0.0001
72388648|NCT01397890|144285636|SUPERIORITY_OR_OTHER||Ratio|1.044||||0.0004|TWO_SIDED|95.0|1.019|1.069|||ANCOVA|multiplicative ANCOVA model with treatment and country as fixed factors and baseline value as a (log-transformed) covariate||||1.069|1.019|0.0004
72388649|NCT01397890|144285637|SUPERIORITY_OR_OTHER||Ratio|1.079|||<|0.0001|TWO_SIDED|95.0|1.057|1.102|||ANCOVA|Multiplicative ANCOVA model with treatment and country as fixed factors and week 0 pre-dose value as a (log-transformed) covariate.||||1.102|1.057|<0.0001
72388650|NCT01397890|144285638|SUPERIORITY_OR_OTHER||Ratio|1.086|||<|0.0001|TWO_SIDED|95.0|1.062|1.111|||ANCOVA|Multiplicative ANCOVA model with treatment and country as fixed factors and week 0 pre-dose value as a (log-transformed) covariate.||||1.111|1.062|<0.0001
72388651|NCT01397890|144285639|SUPERIORITY_OR_OTHER||Ratio|1.018||||0.057|TWO_SIDED|95.0|0.999|1.037|||ANCOVA|Multiplicative ANCOVA model with treatment and country as fixed factors and week 0 pre-dose value as a (log-transformed) covariate.||||1.037|0.999|0.0570
72388652|NCT01397890|144285640|SUPERIORITY_OR_OTHER||Ratio|1.05|||<|0.0001|TWO_SIDED|95.0|1.033|1.067|||ANCOVA|Multiplicative ANCOVA model with treatment and country as fixed factors and week 0 pre-dose value as a (log-transformed) covariate.||||1.067|1.033|<0.0001
72388653|NCT01397890|144285641|SUPERIORITY_OR_OTHER||Ratio|1.054|||<|0.0001|TWO_SIDED|95.0|1.036|1.073|||ANCOVA|Multiplicative ANCOVA model with treatment and country as fixed factors and week 0 pre-dose value as a (log-transformed) covariate.||||1.073|1.036|<0.0001
72388654|NCT01397890|144285642|SUPERIORITY_OR_OTHER||Ratio|1.02||||0.1956|TWO_SIDED|95.0|0.99|1.05|||ANCOVA|Multiplicative ANCOVA model with treatment and country as fixed factors and week 0 pre-dose value as a (log-transformed) covariate.||||1.050|0.990|0.1956
72388655|NCT01397890|144285643|SUPERIORITY_OR_OTHER||Ratio|1.062|||<|0.0001|TWO_SIDED|95.0|1.035|1.091|||ANCOVA|Multiplicative ANCOVA model with treatment and country as fixed factors and week 0 pre-dose value as a (log-transformed) covariate.||||1.091|1.035|<0.0001
72388656|NCT01397890|144285644|SUPERIORITY_OR_OTHER||Mean Difference (Net)|20.303||||0.0001|TWO_SIDED|95.0|9.904|30.702|||ANCOVA|Additive ANCOVA model with treatment and centre as fixed factors and the run-in mean of pre-dose morning PEF as a covariate||||30.702|9.904|0.0001
72388657|NCT01397890|144285645|SUPERIORITY_OR_OTHER||Mean Difference (Net)|13.587|||<|0.0001|TWO_SIDED|95.0|7.407|19.766|||ANCOVA|Additive ANCOVA model with treatment and centre as fixed factors and the run-in mean of pre-dose morning PEF as a covariate||||19.766|7.407|<0.0001
72388658|NCT01397890|144285646|SUPERIORITY_OR_OTHER||Mean Difference (Net)|17.469|||<|0.0001|TWO_SIDED|95.0|10.147|24.791|||ANCOVA|Additive ANCOVA model with treatment and centre as fixed factors and the run-in mean of pre-dose morning PEF as a covariate||||24.791|10.147|<0.0001
72388659|NCT01397890|144285647|SUPERIORITY_OR_OTHER||Mean Difference (Net)|26.428||||0.0001|TWO_SIDED|95.0|13.463|39.393|||ANCOVA|Additive ANCOVA model with treatment and centre as fixed factors and the run-in mean of pre-dose morning PEF as a covariate||||39.393|13.463|0.0001
72496862|NCT04660643|144523211|SUPERIORITY||LS Mean difference|-7.62|STANDARD_ERROR_OF_MEAN|1.707|<|0.001|TWO_SIDED|95.0|-10.91|-4.21|||Mixed Models Analysis|||LDL Cholesterol||-4.21|-10.91|<.001
72496863|NCT04660643|144523211|SUPERIORITY||LS Mean difference|2.6|STANDARD_ERROR_OF_MEAN|1.418||0.064|TWO_SIDED|95.0|-0.14|5.43|||Mixed Models Analysis|||HDL Cholesterol||5.43|-0.14|0.064
72496864|NCT04660643|144523211|SUPERIORITY||LS Mean difference|-20.1|STANDARD_ERROR_OF_MEAN|2.38|<|0.001|TWO_SIDED|95.0|-24.7|-15.3|||Mixed Models Analysis|||VLDL Cholesterol||-15.3|-24.7|<.001
72496865|NCT04660643|144523211|SUPERIORITY||LS Mean difference|-21.2|STANDARD_ERROR_OF_MEAN|2.38|<|0.001|TWO_SIDED|95.0|-25.8|-16.4|||Mixed Models Analysis|||Triglycerides||-16.4|-25.8|<.001
72496866|NCT04660643|144523211|SUPERIORITY||LS Mean difference|-11.83|STANDARD_ERROR_OF_MEAN|3.793||0.004|TWO_SIDED|95.0|-18.98|-4.06|||Mixed Models Analysis|||FFA||-4.06|-18.98|0.004
72496867|NCT04660643|144523212|SUPERIORITY||LS Mean difference|-6.9|||<|0.001|TWO_SIDED|95.0|-8.7|-5.1|||Mixed Models Analysis|||SBP||-5.1|-8.7|<.001
72496868|NCT04660643|144523212|SUPERIORITY||LS Mean difference|-3.8|||<|0.001|TWO_SIDED|95.0|-5.1|-2.6|||Mixed Models Analysis|||DBP||-2.6|-5.1|<.001
72388660|NCT01397890|144285648|SUPERIORITY_OR_OTHER||Mean Difference (Net)|17.192||||0.0006|TWO_SIDED|95.0|7.491|26.894|||ANCOVA|Additive ANCOVA model with treatment and centre as fixed factors and the run-in mean of pre-dose morning PEF as a covariate||||26.894|7.491|0.0006
72388661|NCT01397890|144285649|SUPERIORITY_OR_OTHER||Mean Difference (Net)|18.472|||<|0.0001|TWO_SIDED|95.0|10.347|26.596|||ANCOVA|Additive ANCOVA model with treatment and centre as fixed factors and the run-in mean of pre-dose morning PEF as a covariate||||26.596|10.347|<0.0001
72388662|NCT01397890|144285650|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.668|||<|0.0001|TWO_SIDED|95.0|-0.9|-0.437|||ANCOVA|Additive ANCOVA model with treatment and centre as fixed factors and the run-in mean of pre-dose morning PEF as a covariate||||-0.437|-0.900|<0.0001
72388663|NCT01397890|144285651|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.375|||<|0.0001|TWO_SIDED|95.0|-0.552|-0.198|||ANCOVA|Additive ANCOVA model with treatment and centre as fixed factors and the run-in mean of pre-dose morning PEF as a covariate||||-0.198|-0.552|<0.0001
72388664|NCT01397890|144285652|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.551|||<|0.0001|TWO_SIDED|95.0|-0.741|-0.361|||ANCOVA|Additive ANCOVA model with treatment and centre as fixed factors and the run-in mean of pre-dose morning PEF as a covariate||||-0.361|-0.741|<0.0001
72388665|NCT01397890|144285653|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.236||||0.0028|TWO_SIDED|95.0|-0.391|-0.082|||ANCOVA|Additive ANCOVA model with treatment and centre as fixed factors and the run-in mean of pre-dose morning PEF as a covariate||||-0.082|-0.391|0.0028
72388666|NCT01397890|144285654|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.124||||0.0372|TWO_SIDED|95.0|-0.24|-0.007|||ANCOVA|Additive ANCOVA model with treatment and centre as fixed factors and the run-in mean of pre-dose morning PEF as a covariate||||-0.007|-0.240|0.0372
72496869|NCT04660643|144523213|SUPERIORITY||LS Mean difference|2.7|||<|0.001|TWO_SIDED|95.0|1.7|3.7|||ANCOVA|||||3.7|1.7|<.001
72496870|NCT04660643|144523214|SUPERIORITY||LS Mean difference|9.3|||<|0.001|TWO_SIDED|95.0|6.5|12.0|||ANCOVA|||||12.0|6.5|<.001
72496871|NCT03988907|144523215|OTHER|Descriptive statistics. A sample size of 26 evaluable participants ensures that the two-sided 90% confidence interval for the geometric population mean of the individual exposure ratios of Day 16 to Day 1 will lie within the 0.75 to 1.33 limits of the geometric population mean with at least 80% probability (power).|Ratio of Geometric Least Squares Means|1.08|||||TWO_SIDED|90.0|0.93|1.26||||||||1.26|0.93|
72496872|NCT03988907|144523216|OTHER|Descriptive statistics. A sample size of 26 evaluable participants ensures that the two-sided 90% confidence interval for the geometric population mean of the individual exposure ratios of Day 16 to Day 1 will lie within the 0.75 to 1.33 limits of the geometric population mean with at least 80% probability (power).|Ratio of Geometric Least Squares Means|1.11|||||TWO_SIDED|90.0|1.02|1.2||||||||1.20|1.02|
72496873|NCT03988907|144523217|OTHER|Descriptive statistics. A sample size of 26 evaluable participants ensures that the two-sided 90% confidence interval for the geometric population mean of the individual exposure ratios of Day 16 to Day 1 will lie within the 0.75 to 1.33 limits of the geometric population mean with at least 80% probability (power).|Ratio of Geometric Least Squares Means|1.16|||||TWO_SIDED|90.0|1.06|1.28||||||||1.28|1.06|
72496874|NCT03988907|144523218|OTHER|Descriptive statistics. A sample size of 26 evaluable participants ensures that the two-sided 90% confidence interval for the geometric population mean of the individual exposure ratios of Day 16 to Day 1 will lie within the 0.75 to 1.33 limits of the geometric population mean with at least 80% probability (power).|Ratio of Geometric Least Squares Means|1.12|||||TWO_SIDED|90.0|0.99|1.27||||||||1.27|0.99|
72496875|NCT03988907|144523219|OTHER|Descriptive statistics. A sample size of 26 evaluable participants ensures that the two-sided 90% confidence interval for the geometric population mean of the individual exposure ratios of Day 16 to Day 1 will lie within the 0.75 to 1.33 limits of the geometric population mean with at least 80% probability (power).|Ratio of Geometric Least Squares Means|1.2|||||TWO_SIDED|90.0|1.11|1.3||||||||1.30|1.11|
72496876|NCT03988907|144523220|OTHER|Descriptive statistics. A sample size of 26 evaluable participants ensures that the two-sided 90% confidence interval for the geometric population mean of the individual exposure ratios of Day 16 to Day 1 will lie within the 0.75 to 1.33 limits of the geometric population mean with at least 80% probability (power).|Ratio of Geometric Least Squares Means|1.27|||||TWO_SIDED|90.0|1.14|1.41||||||||1.41|1.14|
72496877|NCT01734655|144523242|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||correlation analysis|||||||<.01
72496878|NCT01734655|144523243|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||correlation analysis|||||||<.01
72496879|NCT01734655|144523244|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||correlation analysis|||||||<.01
72504678|NCT02495077|144540101|SUPERIORITY|||||||0.153|||||||Chi-squared|||||||0.153
72504679|NCT02495077|144540102|SUPERIORITY|||||||0.171|||||||Fisher Exact|||||||0.171
72388667|NCT01397890|144285655|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.231||||0.0001|TWO_SIDED|95.0|-0.35|-0.113|||ANCOVA|Additive ANCOVA model with treatment and centre as fixed factors and the run-in mean of pre-dose morning PEF as a covariate||||-0.113|-0.350|0.0001
72388668|NCT01397890|144285656|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.262|||<|0.0001|TWO_SIDED|95.0|-0.364|-0.159|||ANCOVA|Additive ANCOVA model with treatment and centre as fixed factors and the run-in mean of pre-dose morning PEF as a covariate||||-0.159|-0.364|<0.0001
72388669|NCT01397890|144285657|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.143||||0.0067|TWO_SIDED|95.0|-0.246|-0.04|||ANCOVA|Additive ANCOVA model with treatment and centre as fixed factors and the run-in mean of pre-dose morning PEF as a covariate||||-0.040|-0.246|0.0067
72388670|NCT01397890|144285658|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.122||||0.0171|TWO_SIDED|95.0|-0.222|-0.022|||ANCOVA|Additive ANCOVA model with treatment and centre as fixed factors and the run-in mean of pre-dose morning PEF as a covariate||||-0.022|-0.222|0.0171
72388671|NCT01397890|144285659|SUPERIORITY_OR_OTHER||Rate ratio|0.593||||0.0032|TWO_SIDED|95.0|0.419|0.839|||Poisson regression|Poisson regression model with treatment as a factor and the duration time in study as an offset variable morning PEF as a covariate||||0.839|0.419|0.0032
72388672|NCT01397890|144285659|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.614||||0.0167|TWO_SIDED|95.0|0.412|0.916|||Regression, Cox|Time to the first COPD exacerbation||||0.916|0.412|0.0167
72388673|NCT01397890|144285659|SUPERIORITY_OR_OTHER|||||||0.0196|||||||Log Rank|||||||0.0196
72388674|NCT00002651|144285660|NON_INFERIORITY_OR_EQUIVALENCE|The overall type I error rate used is 0.05. The type II error rate is 0.10 (power = 0.9). The trial planned for a one-sided test of the hypothesis that the hazard ratio of intermittent CAD to continuous CAD is 1.2. A hazard ratio of 1.0 was used as the specific alternative in the trial size computations. Thus, rejection of the hypothesis will be evidence against the possibility that the intermittent CAD hazard ratio is larger than the continuous CAD hazard ratio by 20% or more.|Hazard Ratio (HR)|1.1||||0.15|TWO_SIDED|90.0|0.99|1.23|||Regression, Cox|||||1.23|0.99|0.15
72388675|NCT00002651|144285661|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.83||||0.09|TWO_SIDED|95.0|-0.31|3.97||The type I error rate used was 0.005 in an attempt to adjust for multiple primary scores being tested.The type II error rate used was 0.10 (power = 0.9).|t-test, 2 sided|||||3.97|-0.31|0.09
72388676|NCT00002651|144285662|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.88||||0.003|TWO_SIDED|95.0|1.0|4.76||The type I error rate used was 0.005 in an attempt to adjust for multiple primary scores being tested.The type II error rate used was 0.10 (power = 0.9).|t-test, 2 sided|||||4.76|1.00|0.003
72388677|NCT00002651|144285663|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-10.0|||<|0.001|TWO_SIDED|95.0|-14.0|-5.0||The type I error rate used was 0.005 in an attempt to adjust for multiple primary scores being tested.The type II error rate used was 0.10 (power = 0.9).|t-test, 2 sided|||||-5|-14|<0.001
72388678|NCT00002651|144285664|SUPERIORITY_OR_OTHER||Mean Difference (Net)|18.0||||0.04|TWO_SIDED|95.0|1.0|36.0||The type I error rate used was 0.005 in an attempt to adjust for multiple primary scores being tested.The type II error rate used was 0.10 (power = 0.9).|t-test, 2 sided|||||36|1|0.04
72388679|NCT00002651|144285665|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.32||||0.23|TWO_SIDED|95.0|-0.83|3.46||The type I error rate used was 0.005 in an attempt to adjust for multiple primary scores being tested.The type II error rate used was 0.10 (power = 0.9).|t-test, 2 sided|||||3.46|-0.83|0.23
72622377|NCT05524948|144774645|OTHER||Adjusted Mean Difference|-322.75|STANDARD_ERROR_OF_MEAN|67.778|<|0.0001|TWO_SIDED|95.0|-457.27|-188.23|||ANCOVA|Analysis was performed using ANCOVA model with study product and gender as a factor and baseline concentration as a covariate.||||-188.23|-457.27|<0.0001
72496880|NCT03932799|144523254|SUPERIORITY|Adjusted for workers' compensation-based covariates: age, gender, urban/rural residence, coronavirus disease (COVID)-19 era injury, days from injury to Report of Accident, injury type, injury complexity/severity, days from injury to first opioid prescription, more than 7 days of opioids in acute phase, and health care utilization during baseline period/acute phase.|Odds Ratio (OR)|0.25|||<|0.001|TWO_SIDED|95.0|0.16|0.38||"* two-tailed test~* p-values \< 0.05 are statistically significant"|Regression, Logistic|||"* Primary predictor is binary (1 for Washington, 0 for Ohio)~* Robust variance estimates"||0.38|0.16|<.001
72496881|NCT03932799|144523255|SUPERIORITY|Adjusted for workers' compensation-based covariates: age, gender, urban/rural residence, COVID-19 era injury, days from injury to Report of Accident, injury type, injury complexity/severity, days from injury to first opioid prescription, more than 7 days of opioids in acute phase, health care utilization during baseline period/acute phase, and time indicator for each time period (0,1,2).|Odds Ratio (OR)|0.83||||0.43|TWO_SIDED|95.0|0.53|1.31||"* two-tailed test~* p-values \< 0.05 are statistically significant"|Generalized estimating equation|||"* Primary predictor is binary (1 for Washington, 0 for Ohio)~* Outcome modeled longitudinally over the 3 time periods (3-6, 6-9, and 9-12 months)~* Time periods clustered at the individual worker level~* Exchangeable working correlation structure~* Robust variance estimates"||1.31|0.53|.43
72496882|NCT03932799|144523258|SUPERIORITY|Adjusted for workers' compensation-based covariates: age, gender, urban/rural residence, COVID-19 era injury, days from injury to Report of Accident, injury type, injury complexity/severity, days from injury to first opioid prescription, more than 7 days of opioids in acute phase, health care utilization during baseline period/acute phase, and time indicator for each time period (0,1,2).|Odds Ratio (OR)|3.04||||0.002|TWO_SIDED|95.0|1.5|6.14||"* two-tailed test~* p-values \< 0.05 are statistically significant"|Generalized estimating equation|||"* Primary predictor is binary (1 for Washington, 0 for Ohio)~* Outcome modeled longitudinally over the 3 time periods (3-6, 6-9, and 9-12 months)~* Time periods clustered at the individual worker level~* Exchangeable working correlation structure~* Robust variance estimates"||6.14|1.50|.002
72496883|NCT03932799|144523259|SUPERIORITY|Adjusted for same covariates as primary outcomes, plus survey covariates: days from injury to baseline survey, education, household income, race/ethnicity, working for pay, recovery expectations, anxious symptoms, depressive symptoms, pre-injury opioid, chiropractic and physical therapy (PT) utilization during baseline period/acute phase, cannabis for injury pain, alcohol misuse risk, current tobacco use, pain intensity/interference, Functional Comorbidity Index, health status, quality of life.|Odds Ratio (OR)|0.97||||0.84|TWO_SIDED|95.0|0.71|1.32||"* two-tailed test~* p-values \< 0.05 are statistically significant"|Regression, Logistic|||"* Primary predictor is binary (1 for Washington, 0 for Ohio)~* Models survey weighted~* Robust variance estimates"||1.32|0.71|.84
72496884|NCT03932799|144523260|SUPERIORITY|Adjusted for same covariates as primary outcomes, plus survey-based covariates: days from injury to baseline survey date, education, household income, race/ethnicity, working for pay, recovery expectations, anxious symptoms, depressive symptoms, pre-injury opioid, chiropractic and PT utilization during baseline period/acute phase, cannabis for injury pain, alcohol misuse risk, current tobacco use, pain intensity/interference, Functional Comorbidity Index, health status, and quality of life.|Odds Ratio (OR)|1.03||||0.88|TWO_SIDED|95.0|0.71|1.49||"* two-tailed test~* p-values \< 0.05 are statistically significant"|Regression, Logistic|||"* Primary predictor is binary (1 for Washington, 0 for Ohio)~* Models survey weighted~* Robust variance estimates"||1.49|0.71|.88
72504680|NCT02495077|144540103|SUPERIORITY|||||||0.163|||||||Chi-squared|||||||0.163
72504681|NCT02495077|144540104|SUPERIORITY|||||||0.572|||||||Chi-squared|||||||0.572
72504682|NCT02495077|144540105|SUPERIORITY|||||||0.973|||||||Chi-squared|||||||0.973
72504683|NCT02495077|144540106|SUPERIORITY|||||||0.152|||||||Chi-squared|||||||0.152
72504684|NCT02495077|144540107|SUPERIORITY|||||||0.004|||||||Chi-squared|||||||0.004
72504685|NCT02495077|144540108|SUPERIORITY||||||>|0.999|||||||Fisher Exact|||||||>0.999
72504686|NCT02495077|144540109|SUPERIORITY|||||||0.347|||||||Chi-squared|||||||0.347
72504687|NCT01709799|144540117|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||P-value is not adjusted for multiple comparisons, and p \< .05 is the a priori threshold for statistical significance|Mixed Models Analysis|degrees of freedom are (2,90.577)||Occasion main effect. Null hypothesis is no improvement (Occasion main effect has p-value \> .05)||||< .001
72504688|NCT01709799|144540117|SUPERIORITY_OR_OTHER|||||||0.995|TWO_SIDED|||||The p-value is not adjusted for multiple comparisons, and the a priori threshold for statistical significance was 0.05|Mixed Models Analysis|Degrees of freedom are (4,90.564)||Occasion by arm interaction. Null hypothesis of no group differences in improvement (Interaction has p-value \> .05)||||0.995
72504689|NCT01709799|144540118|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||P-value is not adjusted for multiple comparisons, and p \< .05 is the a priori threshold for statistical significance|Mixed Models Analysis|degrees of freedom are (2,97.137)||Occasion main effect. Null hypothesis is no improvement (Occasion main effect has p-value \> .05)||||<.001
72504690|NCT01709799|144540118|SUPERIORITY_OR_OTHER|||||||0.254|TWO_SIDED|||||P-value is not adjusted for multiple comparisons, and p \< .05 is the a priori threshold for statistical significance|Mixed Models Analysis|degrees of freedom are (4,97.108)||Occasion by arm interaction. Null hypothesis of no group differences in improvement (Interaction has p-value \> .05)||||0.254
72504691|NCT01709799|144540119|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||P-value is not adjusted for multiple comparisons, and p \< .05 is the a priori threshold for statistical significance|Mixed Models Analysis|degrees of freedom are (2,99.647)||Occasion main effect. Null hypothesis is no improvement (Occasion main effect has p-value \> .05)||||<0.001
72504692|NCT01709799|144540119|SUPERIORITY_OR_OTHER|||||||0.781|TWO_SIDED|||||P-value is not adjusted for multiple comparisons, and p \< .05 is the a priori threshold for statistical significance|Mixed Models Analysis|degrees of freedom are (4,99.601)||Occasion by arm interaction. Null hypothesis of no group differences in improvement (Interaction has p-value \> .05)||||0.781
72504693|NCT01709799|144540120|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||P-value is not adjusted for multiple comparisons, and p \< .05 is the a priori threshold for statistical significance|Mixed Models Analysis|degrees of freedom are (2,102.315)||Occasion main effect. Null hypothesis is no improvement (Occasion main effect has p-value \> .05)||||<0.001
72560050|NCT01139762|144650648|SUPERIORITY_OR_OTHER||LS Mean Difference|0.93|||<|0.001|TWO_SIDED|95.0|0.61|1.25||P-value is for 4 weeks.|Mixed Model Repeated Measures Analysis|The Kenward-Roger approximation was used to estimate denominator degrees of freedom.||MMRM model includes treatment, region, visit, and treatment-by-visit interaction as fixed effects, and subject as a random effect. Baseline IIEF was the covariate. No imputation of missing IIEF data was performed. The within-subject errors were modeled using an unstructured covariance structure.||1.25|0.61|<0.001
72560051|NCT01139762|144650648|SUPERIORITY_OR_OTHER||LS Mean Difference|0.79|||<|0.001|TWO_SIDED|95.0|0.44|1.14||P-value is for 12 weeks.|Mixed Model Repeated Measures Analysis|The Kenward-Roger approximation was used to estimate denominator degrees of freedom.||MMRM model includes treatment, region, visit, and treatment-by-visit interaction as fixed effects, and subject as a random effect. Baseline IIEF was the covariate. No imputation of missing IIEF data was performed. The within-subject errors were modeled using an unstructured covariance structure.||1.14|0.44|<0.001
72388680|NCT00304746|144285682|SUPERIORITY_OR_OTHER|||||||0.71||95.0||||For a complete presentation of the above analysis, please see the published paper presenting the full results of this study.|mixed effects linear regression analysis|||Our primary analysis of efficacy was a mixed effects linear regression analysis comparing the rate of change of score on the HAM-D during the blinded treatment phase between groups. Our model for the mean of the outcome variable included terms for treatment, time (modeled as a continuous variable), and treatment-by-time. The measure of effect was the treatment-by-time interaction, which can be interpreted as the difference in slope with respect to time, of the outcome measure.||||0.71
72388681|NCT02100514|144285696|SUPERIORITY_OR_OTHER||LS mean difference compared to placebo|-49.9|STANDARD_ERROR_OF_MEAN|2.09|<|0.001|TWO_SIDED|95.0|-54.0|-45.8|||MMRM|||Least square (LS) mean difference and associated 95% confidence interval (CI), and p-value were derived from an mixed effect model repeat measurement (MMRM) model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-45.8|-54.0|<0.001
72388682|NCT02100514|144285697|SUPERIORITY_OR_OTHER||LS mean difference compared to placebo|-33.2|STANDARD_ERROR_OF_MEAN|1.48|<|0.001|TWO_SIDED|95.0|-36.1|-30.2|||MMRM|||Week 12: LS mean difference and associated 95% CI and p-value were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-30.2|-36.1|<0.001
72388683|NCT02100514|144285697|SUPERIORITY_OR_OTHER||LS mean difference compared to placebo|-29.6|STANDARD_ERROR_OF_MEAN|1.66|||TWO_SIDED|95.0|-32.8|-26.3||||||Week 24: LS mean difference and associated 95% CI were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-26.3|-32.8|
72388684|NCT02100514|144285697|SUPERIORITY_OR_OTHER||LS mean difference compared to placebo|-23.8|STANDARD_ERROR_OF_MEAN|1.65|||TWO_SIDED|95.0|-27.0|-20.5||||||Week 52: LS mean difference and associated 95% CI were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-20.5|-27.0|
72388685|NCT02100514|144285698|SUPERIORITY_OR_OTHER||LS mean difference compared to placebo|-45.7|STANDARD_ERROR_OF_MEAN|2.04|<|0.001|TWO_SIDED|95.0|-49.7|-41.7|||MMRM|||Week 12: LS mean difference and associated 95% CI, and p-value were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-41.7|-49.7|<0.001
72388686|NCT02100514|144285698|SUPERIORITY_OR_OTHER||LS mean difference compared to placebo|-40.9|STANDARD_ERROR_OF_MEAN|2.26|||TWO_SIDED|95.0|-45.3|-36.5||||||Week 24: LS mean difference and associated 95% CI, were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-36.5|-45.3|
72388687|NCT02100514|144285698|SUPERIORITY_OR_OTHER||LS mean difference compared to placebo|-32.5|STANDARD_ERROR_OF_MEAN|2.17|||TWO_SIDED|95.0|-36.7|-28.2||||||Week 52: LS mean difference and associated 95% CI, were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-28.2|-36.7|
72388688|NCT02100514|144285699|SUPERIORITY_OR_OTHER||LS mean difference compared to placebo|-45.0|STANDARD_ERROR_OF_MEAN|1.99|<|0.001|TWO_SIDED|95.0|-48.9|-41.1|||MMRM|||Week 12: LS mean difference and associated 95% CI and p-value were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-41.1|-48.9|<0.001
72388689|NCT02100514|144285699|SUPERIORITY_OR_OTHER||LS mean difference compared to placebo|-40.5|STANDARD_ERROR_OF_MEAN|2.21|||TWO_SIDED|95.0|-44.8|-36.1||||||Week 24: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-36.1|-44.8|
72388690|NCT02100514|144285699|SUPERIORITY_OR_OTHER||LS mean difference compared to placebo|-32.7|STANDARD_ERROR_OF_MEAN|2.2|||TWO_SIDED|95.0|-37.0|-28.4||||||Week 52: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-28.4|-37.0|
72388691|NCT02100514|144285700|SUPERIORITY_OR_OTHER||LS mean difference compared to placebo|-51.6|STANDARD_ERROR_OF_MEAN|2.59|<|0.001|TWO_SIDED|95.0|-56.7|-46.6|||MMRM|||Week 12: LS mean difference and associated 95% CI and p-value were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region. An unstructured variance covariance matrix was used.||-46.6|-56.7|<0.001
72443330|NCT04878354|144399926|SUPERIORITY||Mean Difference (Final Values)|0.29|||<|0.0001|TWO_SIDED|95.0|0.24|0.33|||Mixed Models Analysis||Tree SLIT-tablet vs. placebo SLIT-tablet, visit 4|Change from baseline (screening) to visit 4 (pre-TPS). Change from baseline of log transformed concentrations is analyzed in a mixed effects linear model including treatment, visit, and treatment-visit-interaction as fixed effects, log(baseline concentration) as a covariate and subject as random effect. Observed p-value.||0.33|0.24|<0.0001
72443331|NCT04878354|144399926|SUPERIORITY||Mean Difference (Final Values)|0.31|||<|0.0001|TWO_SIDED|95.0|0.26|0.36|||Mixed Models Analysis||Tree SLIT-tablet vs. placebo SLIT-tablet, visit 6|Change from baseline (screening) to visit 6 (end of treatment). Change from baseline of log transformed concentrations is analysed in a mixed effects linear model including treatment, visit, and treatment-visit-interaction as fixed effects, log(baseline concentration) as a covariate and subject as random effect. Observed p-value.||0.36|0.26|<0.0001
72560052|NCT01139762|144650648|SUPERIORITY_OR_OTHER||LS Mean Difference|0.76|||<|0.001|TWO_SIDED|95.0|0.39|1.13||P-value is for 26 weeks.|Mixed Model Repeated Measures Analysis|The Kenward-Roger approximation was used to estimate denominator degrees of freedom.||MMRM model includes treatment, region, visit, and treatment-by-visit interaction as fixed effects, and subject as a random effect. Baseline IIEF was the covariate. No imputation of missing IIEF data was performed. The within-subject errors were modeled using an unstructured covariance structure.||1.13|0.39|<0.001
72560053|NCT01139762|144650649|SUPERIORITY_OR_OTHER|||||||0.034||95.0||||P-value is for overall distribution of responses.|Cochran-Mantel-Haenszel|Adjusted for baseline lower urinary tract symptoms (LUTS) severity.||||||0.034
72443332|NCT01631214|144399934|SUPERIORITY|The primary endpoints were tested at the 5% level (2-sided), accounting for multiplicity using the Hochberg procedure. If the larger of the 2 p-values was significant at the 0.05 level (2-sided), the statistical testing continued to the secondary endpoint in the testing sequence.|Odds Ratio (OR)|0.48|STANDARD_ERROR_OF_MEAN|0.15|<|0.001|TWO_SIDED|95.0|0.36|0.64|||Regression, Logistic|Based on a logistic regression model adjusted for age strata, baseline total hip BMD T-score and presence of severe vertebral fracture at baseline.|Values \< 1 for odds ratio favor romosozumab. The standard error (SE) represents the standard error of log(odds ratio).|||0.64|0.36|<0.001
72443333|NCT01631214|144399934|SUPERIORITY||Risk Ratio (RR)|0.5|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|0.38|0.66|||||SE represents the standard error of log (risk ratio).|"The risk ratio (ratio of percentages, Romosozumab:Alendronate) was based on the Mantel Haenszel method, adjusted for age strata (\<75 vs. ≥75 years), the presence or absence of severe vertebral fracture at baseline, and baseline bone mineral density T-score at the total hip (≤ -2.5, \> -2.5).~Values \< 1 for risk ratio favor romosozumab."||0.66|0.38|
72443334|NCT01631214|144399934|SUPERIORITY||Absolute risk reduction|4.03|STANDARD_ERROR_OF_MEAN|0.78|||TWO_SIDED|95.0|2.5|5.57||||||"The absolute risk reduction (difference in percentages, Alendronate - Romosozumab) was based on the Mantel-Haenszel method adjusted for age strata, baseline total hip BMD T-score (≤ -2.5, \> -2.5), and presence of severe vertebral fracture at baseline.~Positive values for absolute risk reduction favor romosozumab."||5.57|2.50|
72443335|NCT01631214|144399935|SUPERIORITY|The primary endpoints were tested at the 5% level (2-sided), accounting for multiplicity using the Hochberg procedure. If the larger of the 2 p-values was significant at the 0.05 level (2-sided), the statistical testing continued to the secondary endpoint in the testing sequence.|Hazard Ratio (HR)|0.73|STANDARD_ERROR_OF_MEAN|0.09|<|0.001|TWO_SIDED|95.0|0.61|0.88|||Regression, Cox|Model adjusted for age strata, baseline total hip BMD T-score, and presence of severe vertebral fracture at baseline.|Hazard ratio \< 1 favors romosozumab; SE represents the standard error of log (hazard ratio)|||0.88|0.61|<0.001
72443336|NCT01631214|144399936|SUPERIORITY|If the 2 primary endpoints and the specified BMD secondary endpoints were all significant, the nonvertebral fracture at the primary analysis was evaluated based on a 1-sided test (overall α=0.025) determined by the Lan-DeMets alpha spending function that approximates a Pocock boundary, 0.0233 (1-sided).|Hazard Ratio (HR)|0.81|STANDARD_ERROR_OF_MEAN|0.1||0.04|TWO_SIDED|95.0|0.66|0.99||The adjusted 2-sided p-value is reported.|Regression, Cox|Model adjusted for age strata, baseline total hip BMD T-score, and presence of severe vertebral fracture at baseline.|"Based on Cox proportional hazards model adjusting for age strata, baseline total hip BMD T-score, and presence of severe vertebral fracture at baseline.~Hazard ratio \< 1 favors romosozumab; SE represents the standard error of log (hazard ratio)."|||0.99|0.66|0.040
72443337|NCT01631214|144399937|SUPERIORITY|This endpoint was not included in the sequential testing procedure and was analyzed without multiplicity adjustment at a significance level of 0.05 (two-sided).|Hazard Ratio (HR)|0.65|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|0.56|0.76|||Regression, Cox|Model adjusted for age strata, baseline total hip BMD T-score, and presence of severe vertebral fracture at baseline.|"Based on Cox proportional hazards model adjusting for age strata, baseline total hip BMD T-score, and presence of severe vertebral fracture at baseline.~Hazard ratio \< 1 favors romosozumab; SE represents the standard error of log (hazard ratio)."|||0.76|0.56|<0.001
72496885|NCT03932799|144523261|SUPERIORITY|Adjusted for same covariates as primary outcomes, plus survey-based covariates: days from injury to baseline survey date, education, household income, race/ethnicity, working for pay, recovery expectations, anxious symptoms, depressive symptoms, pre-injury opioid, chiropractic and PT utilization during baseline period/acute phase, cannabis for injury pain, alcohol misuse risk, current tobacco use, pain intensity/interference, Functional Comorbidity Index, health status, and quality of life.|Odds Ratio (OR)|0.74||||0.15|TWO_SIDED|95.0|0.49|1.11||"* two-tailed test~* p-values \< 0.05 are statistically significant"|Regression, Logistic|||"* Primary predictor is binary (1 for Washington, 0 for Ohio)~* Models survey weighted~* Robust variance estimates"||1.11|0.49|.15
72560054|NCT01139762|144650650|SUPERIORITY_OR_OTHER|||||||0.031||95.0|||||Van Elteren test|Van Elteren test was stratified by region.||||||0.031
72560055|NCT01139762|144650651|SUPERIORITY_OR_OTHER|||||||0.328||95.0||||P-value is for overall distribution of responses.|Cochran-Mantel-Haenszel|Adjusted for baseline lower urinary tract symptoms (LUTS) severity.||||||0.328
72560056|NCT01139762|144650652|SUPERIORITY_OR_OTHER|||||||0.157||95.0|||||Wilcoxon Rank-Sum test|||||||0.157
72622378|NCT05524948|144774646|OTHER||Adjusted Mean Difference|-250.33|STANDARD_ERROR_OF_MEAN|42.838|<|0.0001|TWO_SIDED|95.0|-335.35|-165.3|||ANCOVA|Analysis was performed using ANCOVA model with study product and gender as a factor and baseline concentration as a covariate.|For Hydrogen Sulfide|||-165.30|-335.35|<0.0001
72496886|NCT03932799|144523262|SUPERIORITY|Adjusted for same covariates as primary outcomes, plus survey-based covariates: days from injury to baseline survey date, education, household income, race/ethnicity, working for pay, recovery expectations, anxious symptoms, depressive symptoms, pre-injury opioid, chiropractic and PT utilization during baseline period/acute phase, cannabis for injury pain, alcohol misuse risk, current tobacco use, pain intensity/interference, Functional Comorbidity Index, health status, and quality of life.|Odds Ratio (OR)|0.85||||0.38|TWO_SIDED|95.0|0.6|1.21||"* two-tailed test~* p-values \< 0.05 are statistically significant"|Regression, Logistic|||"* Primary predictor is binary (1 for Washington, 0 for Ohio)~* Models survey weighted~* Robust variance estimates"||1.21|0.60|.38
72496887|NCT03932799|144523263|SUPERIORITY|Adjusted for same covariates as primary outcomes, plus survey-based covariates: days from injury to baseline survey date, education, household income, race/ethnicity, working for pay, recovery expectations, anxious symptoms, depressive symptoms, pre-injury opioid, chiropractic and PT utilization during baseline period/acute phase, cannabis for injury pain, alcohol misuse risk, current tobacco use, pain intensity/interference, Functional Comorbidity Index, health status, and quality of life.|Odds Ratio (OR)|1.44||||0.12|TWO_SIDED|95.0|0.91|2.28||"* two-tailed test~* p-values \< 0.05 are statistically significant"|Regression, Logistic|||"* Leisure or social activities outcome~* Primary predictor is binary (1 for Washington, 0 for Ohio)~* Models survey weighted~* Robust variance estimates"||2.28|0.91|.12
72443338|NCT01631214|144399938|SUPERIORITY|This endpoint was not included in the sequential testing procedure and was analyzed without multiplicity adjustment at a significance level of 0.05 (two-sided).|Odds Ratio (OR)|0.49|STANDARD_ERROR_OF_MEAN|0.14|<|0.001|TWO_SIDED|95.0|0.37|0.64|||Regression, Logistic|Based on logistic regression model adjusted for age strata, baseline total hip BMD T-score and presence of severe vertebral fracture at baseline.|Values \< 1 for odds ratio favor romosozumab. The standard error (SE) represents the standard error of log(odds ratio).|||0.64|0.37|<0.001
72443339|NCT01631214|144399938|SUPERIORITY||Risk Ratio (RR)|0.52|STANDARD_ERROR_OF_MEAN|0.13|||TWO_SIDED|95.0|0.4|0.66|||||SE represents the standard error of log (risk ratio).|"The risk ratio (ratio of percentages, Romosozumab:Alendronate) was based on the Mantel Haenszel method, adjusted for age strata (\<75 vs. ≥75 years), the presence or absence of severe vertebral fracture at baseline, and baseline bone mineral density T-score at the total hip (≤ -2.5, \> -2.5).~Values \< 1 for risk ratio favor romosozumab."||0.66|0.40|
72443340|NCT01631214|144399938|SUPERIORITY||Absolute risk reduction|4.44|STANDARD_ERROR_OF_MEAN|0.84|||TWO_SIDED|95.0|2.8|6.08||||||"The absolute risk reduction (difference in percentages, Alendronate - Romosozumab) was based on the Mantel-Haenszel method adjusted for age strata, baseline total hip BMD T-score (≤ -2.5, \> -2.5), and presence of severe vertebral fracture at baseline.~Positive values for absolute risk reduction favor romosozumab."||6.08|2.80|
72443341|NCT01631214|144399939|SUPERIORITY|This endpoint was not included in the sequential testing procedure and was analyzed without multiplicity adjustment at a significance level of 0.05 (two-sided).|Hazard Ratio (HR)|0.73|STANDARD_ERROR_OF_MEAN|0.11||0.004|TWO_SIDED|95.0|0.59|0.9|||Regression, Cox|Model adjusted for age strata, baseline total hip BMD T-score, and presence of severe vertebral fracture at baseline.|"Based on Cox proportional hazards model adjusting for age strata, baseline total hip BMD T-score, and presence of severe vertebral fracture at baseline.~Hazard ratio \< 1 favors romosozumab; SE represents the standard error of log (hazard ratio)."|||0.90|0.59|0.004
72443342|NCT01631214|144399940|SUPERIORITY|This endpoint was not included in the sequential testing procedure and was analyzed without multiplicity adjustment at a significance level of 0.05 (two-sided).|Hazard Ratio (HR)|0.62|STANDARD_ERROR_OF_MEAN|0.2||0.015|TWO_SIDED|95.0|0.42|0.92|||Regression, Cox|Model adjusted for age strata, baseline total hip BMD T-score, and presence of severe vertebral fracture at baseline.|"Based on Cox proportional hazards model adjusting for age strata, baseline total hip BMD T-score, and presence of severe vertebral fracture at baseline.~Hazard ratio \< 1 favors romosozumab; SE represents the standard error of log (hazard ratio)."|||0.92|0.42|0.015
72443343|NCT01631214|144399941|SUPERIORITY|This endpoint was not included in the sequential testing procedure and was analyzed without multiplicity adjustment at a significance level of 0.05 (two-sided).|Odds Ratio (OR)|0.51|STANDARD_ERROR_OF_MEAN|0.25||0.008|TWO_SIDED|95.0|0.31|0.85|||Regression, Logistic|Based on logistic regression model adjusted for age strata, baseline total hip BMD T-score and presence of severe vertebral fracture at baseline.|Values \< 1 for odds ratio favor romosozumab. The standard error (SE) represents the standard error of log(odds ratio).|||0.85|0.31|0.008
72496888|NCT03932799|144523263|SUPERIORITY|Adjusted for same covariates as primary outcomes, plus survey-based covariates: days from injury to baseline survey date, education, household income, race/ethnicity, working for pay, recovery expectations, anxious symptoms, depressive symptoms, pre-injury opioid, chiropractic and PT utilization during baseline period/acute phase, cannabis for injury pain, alcohol misuse risk, current tobacco use, pain intensity/interference, Functional Comorbidity Index, health status, and quality of life.|Odds Ratio (OR)|1.23||||0.42|TWO_SIDED|95.0|0.74|2.07||"* two-tailed test~* p-values \< 0.05 are statistically significant"|Regression, Logistic|||"* Getting out with friends or family outcome~* Primary predictor is binary (1 for Washington, 0 for Ohio)~* Models survey weighted~* Robust variance estimates"||2.07|0.74|.42
72496889|NCT03932799|144523263|SUPERIORITY|Adjusted for same covariates as primary outcomes, plus survey-based covariates: days from injury to baseline survey date, education, household income, race/ethnicity, working for pay, recovery expectations, anxious symptoms, depressive symptoms, pre-injury opioid, chiropractic and PT utilization during baseline period/acute phase, cannabis for injury pain, alcohol misuse risk, current tobacco use, pain intensity/interference, Functional Comorbidity Index, health status, and quality of life.|Odds Ratio (OR)|0.98||||0.91|TWO_SIDED|95.0|0.63|1.51||"* two-tailed test~* p-values \< 0.05 are statistically significant"|Regression, Logistic|||"* Doing household chores outcome~* Primary predictor is binary (1 for Washington, 0 for Ohio)~* Models survey weighted~* Robust variance estimates"||1.51|0.63|.91
72504694|NCT01709799|144540120|SUPERIORITY_OR_OTHER|||||||0.026|TWO_SIDED|||||P-value is not adjusted for multiple comparisons, and p \< .05 is the a priori threshold for statistical significance|Mixed Models Analysis|degrees of freedom are (4,102.216)||Occasion by arm interaction. Null hypothesis of no group differences in improvement (Interaction has p-value \> .05)||||0.026
72622379|NCT05524948|144774646|OTHER||Adjusted Mean Difference|-45.53|STANDARD_ERROR_OF_MEAN|23.439||0.055|TWO_SIDED|95.0|-92.05|0.99|||ANCOVA|Analysis was performed using ANCOVA model with study product and gender as a factor and baseline concentration as a covariate.|For Methanethiol|||0.99|-92.05|0.0550
72443344|NCT01631214|144399941|SUPERIORITY||Risk Ratio (RR)|0.52|STANDARD_ERROR_OF_MEAN|0.25|||TWO_SIDED|95.0|0.32|0.85|||||SE represents the standard error of log (risk ratio).|"The risk ratio (ratio of percentages, Romosozumab:Alendronate) was based on the Mantel Haenszel method, adjusted for age strata (\<75 vs. ≥75 years), the presence or absence of severe vertebral fracture at baseline, and baseline bone mineral density T-score at the total hip (≤ -2.5, \> -2.5).~Values \< 1 for risk ratio favor romosozumab."||0.85|0.32|
72443345|NCT01631214|144399941|SUPERIORITY||Absolute risk reduction|1.21|STANDARD_ERROR_OF_MEAN|0.45|||TWO_SIDED|95.0|0.33|2.1||||||"The absolute risk reduction (difference in percentages, Alendronate - Romosozumab) was based on the Mantel-Haenszel method adjusted for age strata, baseline total hip BMD T-score (≤ -2.5, \> -2.5), and presence of severe vertebral fracture at baseline.~Positive values for absolute risk reduction favor romosozumab."||2.10|0.33|
72443346|NCT01631214|144399942|SUPERIORITY|This endpoint was not included in the sequential testing procedure and was analyzed without multiplicity adjustment at a significance level of 0.05 (two-sided).|Hazard Ratio (HR)|0.74|STANDARD_ERROR_OF_MEAN|0.11||0.005|TWO_SIDED|95.0|0.59|0.91|||Regression, Cox|Model adjusted for age strata, baseline total hip BMD T-score, and presence of severe vertebral fracture at baseline.|"Based on Cox proportional hazards model adjusting for age strata, baseline total hip BMD T-score, and presence of severe vertebral fracture at baseline.~Hazard ratio \< 1 favors romosozumab; SE represents the standard error of log (hazard ratio)."|||0.91|0.59|0.005
72443347|NCT01631214|144399943|SUPERIORITY|This endpoint was not included in the sequential testing procedure and was analyzed without multiplicity adjustment at a significance level of 0.05 (two-sided).|Hazard Ratio (HR)|0.81|STANDARD_ERROR_OF_MEAN|0.12||0.074|TWO_SIDED|95.0|0.64|1.02|||Regression, Cox|Model adjusted for age strata, baseline total hip BMD T-score, and presence of severe vertebral fracture at baseline.|"Based on Cox proportional hazards model adjusting for age strata, baseline total hip BMD T-score, and presence of severe vertebral fracture at baseline.~Hazard ratio \< 1 favors romosozumab; SE represents the standard error of log (hazard ratio)."|||1.02|0.64|0.074
72443348|NCT01631214|144399944|SUPERIORITY|This endpoint was not included in the sequential testing procedure and was analyzed without multiplicity adjustment at a significance level of 0.05 (two-sided).|Hazard Ratio (HR)|0.72|STANDARD_ERROR_OF_MEAN|0.24||0.17|TWO_SIDED|95.0|0.46|1.15|||Regression, Cox|Model adjusted for age strata, baseline total hip BMD T-score, and presence of severe vertebral fracture at baseline.|"Based on Cox proportional hazards model adjusting for age strata, baseline total hip BMD T-score, and presence of severe vertebral fracture at baseline.~Hazard ratio \< 1 favors romosozumab; SE represents the standard error of log (hazard ratio)."|||1.15|0.46|0.17
72443349|NCT01631214|144399945|SUPERIORITY|This endpoint was not included in the sequential testing procedure and was analyzed without multiplicity adjustment at a significance level of 0.05 (two-sided).|Hazard Ratio (HR)|0.41|STANDARD_ERROR_OF_MEAN|0.28|<|0.001|TWO_SIDED|95.0|0.24|0.71|||Regression, Cox|Model adjusted for age strata, baseline total hip BMD T-score, and presence of severe vertebral fracture at baseline.|"Based on Cox proportional hazards model adjusting for age strata, baseline total hip BMD T-score, and presence of severe vertebral fracture at baseline.~Hazard ratio \< 1 favors romosozumab; SE represents the standard error of log (hazard ratio)."|||0.71|0.24|<0.001
72443350|NCT01631214|144399946|SUPERIORITY|This endpoint was not included in the sequential testing procedure and was analyzed without multiplicity adjustment at a significance level of 0.05 (two-sided).|Hazard Ratio (HR)|0.72|STANDARD_ERROR_OF_MEAN|0.15||0.027|TWO_SIDED|95.0|0.54|0.96|||Regression, Cox|Model adjusted for age strata, baseline total hip BMD T-score, and presence of severe vertebral fracture at baseline.|"Based on Cox proportional hazards model adjusting for age strata, baseline total hip BMD T-score, and presence of severe vertebral fracture at baseline.~Hazard ratio \< 1 favors romosozumab; SE represents the standard error of log (hazard ratio)."|||0.96|0.54|0.027
72443351|NCT01631214|144399947|SUPERIORITY|This endpoint was not included in the sequential testing procedure and was analyzed without multiplicity adjustment at a significance level of 0.05 (two-sided).|Odds Ratio (OR)|0.63|STANDARD_ERROR_OF_MEAN|0.18||0.008|TWO_SIDED|95.0|0.44|0.89|||Regression, Logistic|Based on a logistic regression model adjusted for age strata, baseline total hip BMD T-score and presence of severe vertebral fracture at baseline.|Values \< 1 for odds ratio favor romosozumab. The standard error (SE) represents the standard error of log(odds ratio).|||0.89|0.44|0.008
72443352|NCT01631214|144399947|SUPERIORITY||Risk Ratio (RR)|0.64|STANDARD_ERROR_OF_MEAN|0.17|||TWO_SIDED|95.0|0.46|0.89|||||SE represents the standard error of log (risk ratio).|"The risk ratio (ratio of percentages, Romosozumab:Alendronate) was based on the Mantel Haenszel method, adjusted for age strata (\<75 vs. ≥75 years), the presence or absence of severe vertebral fracture at baseline, and baseline bone mineral density T-score at the total hip (≤ -2.5, \> -2.5).~Values \< 1 for risk ratio favor romosozumab."||0.89|0.46|
72496890|NCT03932799|144523263|SUPERIORITY|Adjusted for same covariates as primary outcomes, plus survey-based covariates: days from injury to baseline survey date, education, household income, race/ethnicity, working for pay, recovery expectations, anxious symptoms, depressive symptoms, pre-injury opioid, chiropractic and PT utilization during baseline period/acute phase, cannabis for injury pain, alcohol misuse risk, current tobacco use, pain intensity/interference, Functional Comorbidity Index, health status, and quality of life.|Odds Ratio (OR)|1.19||||0.59|TWO_SIDED|95.0|0.64|2.21||"* two-tailed test~* p-values \< 0.05 are statistically significant"|Regression, Logistic|||"* Using transportation outcome~* Primary predictor is binary (1 for Washington, 0 for Ohio)~* Models survey weighted~* Robust variance estimates"||2.21|0.64|.59
72496891|NCT03932799|144523264|SUPERIORITY|Adjusted for same covariates as primary outcomes, plus survey-based covariates: days from injury to baseline survey date, education, household income, race/ethnicity, working for pay, recovery expectations, anxious symptoms, depressive symptoms, pre-injury opioid, chiropractic and PT utilization during baseline period/acute phase, cannabis for injury pain, alcohol misuse risk, current tobacco use, pain intensity/interference, Functional Comorbidity Index, health status, and quality of life.|Odds Ratio (OR)|1.24||||0.22|TWO_SIDED|95.0|0.88|1.75||"* two-tailed test~* p-values \< 0.05 are statistically significant"|Regression, Logistic|||"* Primary predictor is binary (1 for Washington, 0 for Ohio)~* Models survey weighted~* Robust variance estimates"||1.75|0.88|.22
72622380|NCT05524948|144774646|OTHER||Adjusted Mean Difference|-32.68|STANDARD_ERROR_OF_MEAN|26.036||0.2124|TWO_SIDED|95.0|-84.36|18.99|||ANCOVA|Analysis was performed using ANCOVA model with study product and gender as a factor and baseline concentration as a covariate.|For Dimethyl Sulfide|||18.99|-84.36|0.2124
72443353|NCT01631214|144399947|SUPERIORITY||Absolute risk reduction|1.84|STANDARD_ERROR_OF_MEAN|0.68|||TWO_SIDED|95.0|0.51|3.17||||||"The absolute risk reduction (difference in percentages, Alendronate - Romosozumab) was based on the Mantel-Haenszel method adjusted for age strata, baseline total hip BMD T-score (≤ -2.5, \> -2.5), and presence of severe vertebral fracture at baseline.~Positive values for absolute risk reduction favor romosozumab."||3.17|0.51|
72443354|NCT01631214|144399948|SUPERIORITY|This endpoint was not included in the sequential testing procedure and was analyzed without multiplicity adjustment at a significance level of 0.05 (two-sided).|Hazard Ratio (HR)|0.71|STANDARD_ERROR_OF_MEAN|0.11||0.002|TWO_SIDED|95.0|0.57|0.88|||Regression, Cox|Model adjusted for age strata, baseline total hip BMD T-score, and presence of severe vertebral fracture at baseline.|"Based on Cox proportional hazards model adjusting for age strata, baseline total hip BMD T-score, and presence of severe vertebral fracture at baseline.~Hazard ratio \< 1 favors romosozumab; SE represents the standard error of log (hazard ratio)."|||0.88|0.57|0.002
72443355|NCT01631214|144399949|SUPERIORITY|This endpoint was not included in the sequential testing procedure and was analyzed without multiplicity adjustment at a significance level of 0.05 (two-sided).|Hazard Ratio (HR)|0.74|STANDARD_ERROR_OF_MEAN|0.16||0.057|TWO_SIDED|95.0|0.54|1.01|||Regression, Cox|Model adjusted for age strata, baseline total hip BMD T-score, and presence of severe vertebral fracture at baseline.|"Based on Cox proportional hazards model adjusting for age strata, baseline total hip BMD T-score, and presence of severe vertebral fracture at baseline.~Hazard ratio \< 1 favors romosozumab; SE represents the standard error of log (hazard ratio)."|||1.01|0.54|0.057
72443356|NCT01631214|144399950|SUPERIORITY|This endpoint was not included in the sequential testing procedure and was analyzed without multiplicity adjustment at a significance level of 0.05 (two-sided).|Hazard Ratio (HR)|0.64|STANDARD_ERROR_OF_MEAN|0.34||0.19|TWO_SIDED|95.0|0.33|1.26|||Regression, Cox|Model adjusted for age strata, baseline total hip BMD T-score, and presence of severe vertebral fracture at baseline.|"Based on Cox proportional hazards model adjusting for age strata, baseline total hip BMD T-score, and presence of severe vertebral fracture at baseline.~Hazard ratio \< 1 favors romosozumab; SE represents the standard error of log (hazard ratio)."|||1.26|0.33|0.19
72443357|NCT01631214|144399951|SUPERIORITY|This endpoint was not included in the sequential testing procedure and was analyzed without multiplicity adjustment at a significance level of 0.05 (two-sided).|Hazard Ratio (HR)|0.72|STANDARD_ERROR_OF_MEAN|0.17||0.053|TWO_SIDED|95.0|0.52|1.01|||Regression, Cox|Model adjusted for age strata, baseline total hip BMD T-score, and presence of severe vertebral fracture at baseline.|"Based on Cox proportional hazards model adjusting for age strata, baseline total hip BMD T-score, and presence of severe vertebral fracture at baseline.~Hazard ratio \< 1 favors romosozumab; SE represents the standard error of log (hazard ratio)."|||1.01|0.52|0.053
72443358|NCT01631214|144399952|SUPERIORITY|This endpoint was not included in the sequential testing procedure and was analyzed without multiplicity adjustment at a significance level of 0.05 (two-sided).|Hazard Ratio (HR)|0.56|STANDARD_ERROR_OF_MEAN|0.39||0.14|TWO_SIDED|95.0|0.26|1.22|||Regression, Cox|Model adjusted for age strata, baseline total hip BMD T-score, and presence of severe vertebral fracture at baseline.|"Based on Cox proportional hazards model adjusting for age strata, baseline total hip BMD T-score, and presence of severe vertebral fracture at baseline.~Hazard ratio \< 1 favors romosozumab; SE represents the standard error of log (hazard ratio)."|||1.22|0.26|0.14
72443359|NCT01631214|144399953|SUPERIORITY|If the differences in both primary end points were significant with the use of the Hochberg procedure, a fixed-sequence testing procedure was used for bone mineral density and the key secondary end point of nonvertebral fracture to adjust for multiple comparisons and to maintain an overall significance level of 0.05.|LS Mean Difference|8.1|STANDARD_ERROR_OF_MEAN|0.3|<|0.001|TWO_SIDED|95.0|7.58|8.57|||ANCOVA|||Between-group comparisons of the percent change from baseline in bone mineral density were analyzed using an analysis of covariance (ANCOVA) model adjusted for treatment, age strata, presence of severe vertebral fracture at baseline, baseline BMD value, machine type, and baseline BMD value-by-machine type interaction.||8.57|7.58|<0.001
72443360|NCT01631214|144399954|SUPERIORITY|If the differences in both primary end points were significant with the use of the Hochberg procedure, a fixed-sequence testing procedure was used for bone mineral density and the key secondary end point of nonvertebral fracture to adjust for multiple comparisons and to maintain an overall significance level of 0.05.|LS Mean Difference|3.8|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|3.42|4.1|||ANCOVA|||Between-group comparisons of the percent change from baseline in bone mineral density were analyzed using an ANCOVA model adjusted for treatment, age strata, presence of severe vertebral fracture at baseline, baseline BMD value, machine type, and baseline BMD value-by-machine type interaction.||4.10|3.42|<0.001
72443361|NCT01631214|144399955|SUPERIORITY|If the differences in both primary end points were significant with the use of the Hochberg procedure, a fixed-sequence testing procedure was used for bone mineral density and the key secondary end point of nonvertebral fracture to adjust for multiple comparisons and to maintain an overall significance level of 0.05.|LS Mean Difference|3.8|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|3.4|4.14|||ANCOVA|||Between-group comparisons of the percent change from baseline in bone mineral density were analyzed using an ANCOVA model adjusted for treatment, age strata, presence of severe vertebral fracture at baseline, baseline BMD value, machine type, and baseline BMD value-by-machine type interaction.||4.14|3.40|<0.001
72496892|NCT03932799|144523265|SUPERIORITY|Adjusted for same covariates as primary outcomes, plus survey-based covariates: days from injury to baseline survey date, education, household income, race/ethnicity, working for pay, recovery expectations, anxious symptoms, depressive symptoms, pre-injury opioid, chiropractic and PT utilization during baseline period/acute phase, cannabis for injury pain, alcohol misuse risk, current tobacco use, pain intensity/interference, Functional Comorbidity Index, health status, and quality of life.|Odds Ratio (OR)|1.97||||0.02|TWO_SIDED|95.0|1.12|3.47||"* two-tailed test~* p-values \< 0.05 are statistically significant"|Regression, Logistic|||"* Primary predictor is binary (1 for Washington, 0 for Ohio)~* Models survey weighted~* Robust variance estimates"||3.47|1.12|.02
72622381|NCT05524948|144774647|OTHER||Adjusted Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|0.164|<|0.0001|TWO_SIDED|95.0|-1.52|-0.87|||ANCOVA|Analysis was performed using ANCOVA model with study product and gender as a factor and Baseline overall breath organoleptic score as a covariate.|Adjusted mean difference was calculated as experimental dentifrice minus reference dentifrice.|||-0.87|-1.52|<0.0001
72622382|NCT05155085|144774648|SUPERIORITY||Risk Difference (RD)|5.1||||0.4662|TWO_SIDED|95.0|-9.8|19.8|||Cochran-Mantel-Haenszel|||||19.8|-9.8|0.4662
72443362|NCT01631214|144399956|SUPERIORITY|If the differences in both primary end points were significant with the use of the Hochberg procedure, a fixed-sequence testing procedure was used for bone mineral density and the key secondary end point of nonvertebral fracture to adjust for multiple comparisons and to maintain an overall significance level of 0.05.|LS Mean Difference|8.7|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|8.31|9.09|||ANCOVA|||Between-group comparisons of the percent change from baseline in bone mineral density were analyzed using an ANCOVA model adjusted for treatment, age strata, presence of severe vertebral fracture at baseline, baseline BMD value, machine type, and baseline BMD value-by-machine type interaction.||9.09|8.31|<0.001
72443363|NCT01631214|144399957|SUPERIORITY|If the differences in both primary end points were significant with the use of the Hochberg procedure, a fixed-sequence testing procedure was used for bone mineral density and the key secondary end point of nonvertebral fracture to adjust for multiple comparisons and to maintain an overall significance level of 0.05.|LS Mean Difference|3.3|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|3.03|3.6|||ANCOVA|||Between-group comparisons of the percent change from baseline in bone mineral density were analyzed using an ANCOVA model adjusted for treatment, age strata, presence of severe vertebral fracture at baseline, baseline BMD value, machine type, and baseline BMD value-by-machine type interaction.||3.60|3.03|<0.001
72443364|NCT01631214|144399958|SUPERIORITY|If the differences in both primary end points were significant with the use of the Hochberg procedure, a fixed-sequence testing procedure was used for bone mineral density and the key secondary end point of nonvertebral fracture to adjust for multiple comparisons and to maintain an overall significance level of 0.05.|LS Mean Difference|3.2|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|2.9|3.54|||ANCOVA|||Between-group comparisons of the percent change from baseline in bone mineral density were analyzed using an ANCOVA model adjusted for treatment, age strata, presence of severe vertebral fracture at baseline, baseline BMD value, machine type, and baseline BMD value-by-machine type interaction.||3.54|2.90|<0.001
72560057|NCT01139762|144650653|SUPERIORITY_OR_OTHER||LS Mean Difference|0.74|||<|0.001|TWO_SIDED|95.0|0.49|0.98||P-value is for Question 3 - 4 weeks.|Mixed Model Repeated Measures Analysis|The Kenward-Roger approximation was used to estimate denominator degrees of freedom.||MMRM model includes treatment, region, visit, and treatment-by-visit interaction as fixed effects, and subject as a random effect. Baseline IIEF was the covariate. No imputation of missing IIEF data was performed. The within-subject errors were modeled using an unstructured covariance structure.||0.98|0.49|<0.001
72388692|NCT02100514|144285700|SUPERIORITY_OR_OTHER||LS mean difference compared to placebo|-46.4|STANDARD_ERROR_OF_MEAN|2.94|||TWO_SIDED|95.0|-52.2|-40.6||||||Week 24: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region. An unstructured variance covariance matrix was used.||-40.6|-52.2|
72388693|NCT02100514|144285700|SUPERIORITY_OR_OTHER||LS mean difference compared to placebo|-37.4|STANDARD_ERROR_OF_MEAN|3.03|||TWO_SIDED|95.0|-43.3|-31.4||||||Week 52: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region. An unstructured variance covariance matrix was used.||-31.4|-43.3|
72388694|NCT02100514|144285701|SUPERIORITY_OR_OTHER||LS mean difference compared to placebo|-46.6|STANDARD_ERROR_OF_MEAN|3.59|<|0.001||95.0|-53.7|-39.5|||MMRM|||Week 12: LS mean difference and associated 95% CI and p-value were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region. An unstructured variance covariance matrix was used.||-39.5|-53.7|<0.001
72388695|NCT02100514|144285701|SUPERIORITY_OR_OTHER||LS mean difference compared to placebo|-39.7|STANDARD_ERROR_OF_MEAN|4.12||||95.0|-47.9|-31.6||||||Week 24: LS mean difference and associated 95% CI were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region. An unstructured variance covariance matrix was used.||-31.6|-47.9|
72388696|NCT02100514|144285701|SUPERIORITY_OR_OTHER||LS mean difference compared to placebo|-33.4|STANDARD_ERROR_OF_MEAN|4.02||||95.0|-41.3|-25.5||||||Week 52: LS mean difference and associated 95% CI were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region. An unstructured variance covariance matrix was used.||-25.5|-41.3|
72622383|NCT05155085|144774649|SUPERIORITY||LSM Difference from Placebo|-9.7|STANDARD_ERROR_OF_MEAN|11.4||0.3968|TWO_SIDED|95.0|-32.2|12.9|||Mixed Models Analysis|||||12.9|-32.2|0.3968
72622384|NCT05155085|144774650|SUPERIORITY||Risk Difference (RD)|3.3||||0.7625|TWO_SIDED|95.0|-15.2|21.6|||Fisher Exact|||||21.6|-15.2|0.7625
72388697|NCT02100514|144285702|SUPERIORITY_OR_OTHER||LS mean difference compared to placebo|-30.8|STANDARD_ERROR_OF_MEAN|3.14|<|0.001||95.0|-36.9|-24.6|||MMRM|||Week 12: LS mean difference and associated 95% CI and p-value were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-24.6|-36.9|<0.001
72388698|NCT02100514|144285702|SUPERIORITY_OR_OTHER||LS mean difference compared to placebo|-27.5|STANDARD_ERROR_OF_MEAN|3.23||||95.0|-33.9|-21.2||||||Week 24: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-21.2|-33.9|
72388699|NCT02100514|144285702|SUPERIORITY_OR_OTHER||LS mean difference compared to placebo|-49.4|STANDARD_ERROR_OF_MEAN|18.27|||TWO_SIDED|95.0|-85.2|-13.5||||||Week 52: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-13.5|-85.2|
72388700|NCT02100514|144285703|SUPERIORITY_OR_OTHER||LS mean difference compared to placebo|5.5|STANDARD_ERROR_OF_MEAN|1.06|<|0.001|TWO_SIDED|95.0|3.4|7.6|||MMRM|||Week 12: LS mean difference and associated 95% CI and p-value were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||7.6|3.4|<0.001
72443365|NCT01631214|144399959|SUPERIORITY|This endpoint was not included in the sequential testing procedure and was analyzed without multiplicity adjustment at a significance level of 0.05 (two-sided).|LS Mean Difference|7.4|STANDARD_ERROR_OF_MEAN|0.3|<|0.001|TWO_SIDED|95.0|6.84|7.89|||ANCOVA|||Between-group comparisons of the percent change from baseline in bone mineral density were analyzed using an ANCOVA model adjusted for treatment, age strata, presence of severe vertebral fracture at baseline, baseline BMD value, machine type, and baseline BMD value-by-machine type interaction.||7.89|6.84|<0.001
72443366|NCT01631214|144399960|SUPERIORITY|This endpoint was not included in the sequential testing procedure and was analyzed without multiplicity adjustment at a significance level of 0.05 (two-sided).|LS Mean Difference|3.7|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|3.29|4.02|||ANCOVA|||Between-group comparisons of the percent change from baseline in bone mineral density were analyzed using an ANCOVA model adjusted for treatment, age strata, presence of severe vertebral fracture at baseline, baseline BMD value, machine type, and baseline BMD value-by-machine type interaction.||4.02|3.29|<0.001
72443367|NCT01631214|144399961|SUPERIORITY|This endpoint was not included in the sequential testing procedure and was analyzed without multiplicity adjustment at a significance level of 0.05 (two-sided).|LS Mean Difference|3.6|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|3.18|3.97|||ANCOVA|||Between-group comparisons of the percent change from baseline in bone mineral density were analyzed using an ANCOVA model adjusted for treatment, age strata, presence of severe vertebral fracture at baseline, baseline BMD value, machine type, and baseline BMD value-by-machine type interaction.||3.97|3.18|<0.001
72443368|NCT03857620|144399978|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.53|TWO_SIDED|95.0|-0.85|0.45|||Mixed Models Analysis|Generalized linear mixed effects model (w/ Gaussian link) w/ random practice effect to account for clustering by site \& bsl CHAMPS score as covariate||Combined Arm II (OPTI-Surg) \& Arm III (OPTI-Surg plus Coach) vs. Arm I (Usual Care)||0.45|-0.85|0.53
72443369|NCT03857620|144399978|SUPERIORITY||Mean Difference (Final Values)|0.07||||0.84|TWO_SIDED|95.0|-0.67|0.81|||Mixed Models Analysis|Generalized linear mixed effects model (w/ Gaussian link) w/ random practice effect to account for clustering by site \& bsl CHAMPS score as covariate||||0.81|-0.67|0.84
72443370|NCT03857620|144399978|SUPERIORITY||Mean Difference (Final Values)|-0.48||||0.19|TWO_SIDED|95.0|-1.21|0.26|||Mixed Models Analysis|Generalized linear mixed effects model (w/ Gaussian link) w/ random practice effect to account for clustering by site \& bsl CHAMPS score as covariate||||0.26|-1.21|0.19
72443371|NCT03857620|144399978|SUPERIORITY||Mean Difference (Final Values)|0.55||||0.14|TWO_SIDED|95.0|-0.19|1.29|||Mixed Models Analysis|Generalized linear mixed effects model (w/ Gaussian link) w/ random practice effect to account for clustering by site \& bsl CHAMPS score as covariate||||1.29|-0.19|0.14
72443372|NCT03857620|144399979|SUPERIORITY||Odds Ratio (OR)|0.7||||0.5|TWO_SIDED|95.0|0.23|2.09|||Mixed Models Analysis|Generalized linear mixed effects model (with logit link function) with a random practice effect to account for clustering within practice||Combined Arm II (OPTI-Surg) \& Arm III (OPTI-Surg plus Coach) vs. Arm I (Usual Care)||2.09|0.23|0.50
72443373|NCT03857620|144399979|SUPERIORITY||Odds Ratio (OR)|0.46||||0.21|TWO_SIDED|95.0|0.13|1.62|||Mixed Models Analysis|Generalized linear mixed effects model (with logit link function) with a random practice effect to account for clustering within practice||||1.62|0.13|0.21
72443374|NCT03857620|144399979|SUPERIORITY||Odds Ratio (OR)|1.03||||0.96|TWO_SIDED|95.0|0.3|3.54|||Mixed Models Analysis|Generalized linear mixed effects model (with logit link function) with a random practice effect to account for clustering within practice||||3.54|0.30|0.96
72443375|NCT03857620|144399979|SUPERIORITY||Odds Ratio (OR)|0.45||||0.19|TWO_SIDED|95.0|0.13|1.54|||Mixed Models Analysis|Generalized linear mixed effects model (with logit link function) with a random practice effect to account for clustering within practice||||1.54|0.13|0.19
72443376|NCT03433339|144399996|SUPERIORITY||||||=|0.04||||||p-value threshold for statistical significance \<0.05|ANOVA|Mixed ANOVA model considering all available data.||||||=0.040
72443377|NCT05332340|144400024|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.683|TWO_SIDED||||||Kruskal-Wallis|||||||0.683
72443378|NCT03137771|144400037|SUPERIORITY||Hazard Ratio (HR)|0.98||||0.66|TWO_SIDED|95.0|0.68|1.4|||Log Rank|Two-sided test|Reference level = systemic therapy. Cox proportional hazards model stratified by histology (non-squamous vs squamous) and systemic therapy (immunotherapy-based regimens vs chemotherapy- only regimens).|Based on expected 6- and 12-month PFS rates of approximately 60% and 39% for the standard arm, assuming approximately exponential distributions, at least 138 PFS events are needed to detect a hazard ratio of 0.6 (a hazard reduction of 40%) with 95% power and a one-sided significance level of 0.15. The Cox proportional hazards model is stratified by histology and systemic therapy type. The hazard ratio estimate must be ≤ 0.83 for the study to proceed to the phase III component.||1.40|0.68|0.66
72443379|NCT00894543|144400082|SUPERIORITY_OR_OTHER||||||<|0.001||||||P values from comparison of Escitalopram vs placebo in a linear model of the outcome as a function of intervention group and adjusted for race, clinical center, baseline outcome, and visit (week 4 or week 8).|Regression, Linear|Natural log transformations applied to hot flash frequencies for modeling assumptions.||Based on data from the Herbal Alternatives for Menopause (HALT) study, MsFLASH estimated that 90 women in each treatment group provide 90% power to detect a difference between drug and placebo with a 2-sided alpha of 0.025 to account for two primary outcomes of hot flash frequency and severity.||||<0.001
72443380|NCT00894543|144400086|SUPERIORITY_OR_OTHER||||||<|0.001||||||P values from comparison of Escitalopram vs placebo in a linear model of the outcome as a function of intervention group and adjusted for race, clinical center, baseline outcome, and visit (week 4 or week 8).|Regression, Linear|Natural log transformations applied to hot flash frequencies for modeling assumptions.||Based on data from the Herbal Alternatives for Menopause (HALT) study, MsFLASH estimated that 90 women in each treatment group provide 90% power to detect a difference between drug and placebo with a 2-sided alpha of 0.025 to account for two primary outcomes of hot flash frequency and severity.||||<0.001
72443381|NCT00894543|144400087|SUPERIORITY_OR_OTHER|||||||0.001|||||||Regression, Linear|||||||0.001
72443382|NCT03144518|144400088|SUPERIORITY||Partial Eta Squared|0.079||||0.005|TWO_SIDED|90.0|0.014|0.173||ANCOVA, controlling for pre-intervention levels|ANCOVA|ANCOVA, controlling for pre-intervention levels||VAS-Valence Scores||.173|.014|.005
72443383|NCT03144518|144400088|SUPERIORITY||Partial Eta-Squared|0.04||||0.047|TWO_SIDED|90.0|0.0|0.12|||ANCOVA|Controlling for pre-intervention scores||VAS-Arousal Scores||.120|.000|.047
72443384|NCT03144518|144400088|SUPERIORITY||Partial Eta Squared|0.096||||0.002|TWO_SIDED|90.0|0.022|0.196|||ANCOVA|Controlling for pre-intervention levels||Pictorial Scale||.196|.022|.002
72443385|NCT03144518|144400088|SUPERIORITY||Partial Eta Squared|0.002||||0.697|TWO_SIDED|90.0|0.0|0.036|||ANCOVA|Controlling for baseline levels||PANAS Positive Affect Scores||.036|.000|.697
72443386|NCT03144518|144400088|SUPERIORITY||Partial Eta Squared|0.005||||0.462|TWO_SIDED|90.0|0.0|0.053|||ANCOVA|||PANAS Negative Affect Scores||.053|.000|.462
72496893|NCT03932799|144523266|SUPERIORITY|Adjusted for same covariates as primary outcomes, plus survey-based covariates: days from injury to baseline survey date, education, household income, race/ethnicity, working for pay, recovery expectations, anxious symptoms, depressive symptoms, pre-injury opioid, chiropractic and PT utilization during baseline period/acute phase, cannabis for injury pain, alcohol misuse risk, current tobacco use, pain intensity/interference, Functional Comorbidity Index, health status, and quality of life.|Odds Ratio (OR)|1.32||||0.1|TWO_SIDED|95.0|0.95|1.83||"* two-tailed test~* p-values \< 0.05 are statistically significant"|Regression, Logistic|||"* Primary predictor is binary (1 for Washington, 0 for Ohio)~* Models survey weighted~* Robust variance estimates"||1.83|0.95|.10
72496894|NCT03932799|144523268|SUPERIORITY|Adjusted for same covariates as primary outcomes, plus survey-based covariates: days from injury to baseline survey date, education, household income, race/ethnicity, working for pay, recovery expectations, anxious symptoms, depressive symptoms, pre-injury opioid, chiropractic and PT utilization during baseline period/acute phase, cannabis for injury pain, alcohol misuse risk, current tobacco use, pain intensity/interference, Functional Comorbidity Index, health status, and quality of life.|beta|-0.01||||0.53|TWO_SIDED|95.0|-0.03|0.01||"* two-tailed test~* p-values \< 0.05 are statistically significant"|Regression, Logistic|||"* Primary predictor is binary (1 for Washington, 0 for Ohio)~* Models survey weighted~* Robust variance estimates"||0.01|-0.03|.53
72496895|NCT03932799|144523269|SUPERIORITY|Adjusted for same covariates as primary outcomes, plus survey-based covariates: days from injury to baseline survey date, education, household income, race/ethnicity, working for pay, recovery expectations, anxious symptoms, depressive symptoms, pre-injury opioid, chiropractic and PT utilization during baseline period/acute phase, cannabis for injury pain, alcohol misuse risk, current tobacco use, pain intensity/interference, Functional Comorbidity Index, health status, and quality of life.|beta|0.16||||0.053|TWO_SIDED|95.0|0.0|0.32||"* two-tailed test~* p-values \< 0.05 are statistically significant"|Regression, Logistic|||"* Primary predictor is binary (1 for Washington, 0 for Ohio)~* Models survey weighted~* Robust variance estimates"||0.32|-0.00|.053
72504695|NCT01709799|144540121|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||P-value is not adjusted for multiple comparisons, and p \< .05 is the a priori threshold for statistical significance|Mixed Models Analysis|degrees of freedom are (2,93.240)||Occasion main effect. Null hypothesis is no improvement (Occasion main effect has p-value \> .05)||||<0.001
72443387|NCT03144518|144400091|SUPERIORITY||Partial Eta Squared|0.001||||0.806|TWO_SIDED|90.0|0.0|0.031|||ANCOVA|Controlling for pre-intervention levels||||.031|.000|.806
72443388|NCT03144518|144400092|SUPERIORITY|Note: The study was not powered a priori to detect significant differences in these outcomes.|Partial Eta Squared|0.006||||0.438|TWO_SIDED|90.0|0.0|0.055|||ANCOVA|Controlling for Pre-Vaccination levels||4 Weeks A/Hong-Kong||.055|.000|.438
72443389|NCT03144518|144400092|SUPERIORITY|Note: The study was not powered a priori to detect significant differences in these outcomes.|Partial Eta Squared|0.004||||0.516|TWO_SIDED|90.0|0.0|0.051|||ANCOVA|controlling for pre-vaccination levels||A/Hong-Kong 16 Weeks Post-Vaccination||.051|.000|.516
72443390|NCT03144518|144400092|SUPERIORITY|Note: The study was not powered a priori to detect significant differences in these outcomes.|Partial Eta Squared|0.002||||0.671|TWO_SIDED|90.0|0.0|0.038|||ANCOVA|controlling for pre-vaccination levels||A/Michigan 4 weeks post-vaccination||.038|.000|.671
72443391|NCT03144518|144400092|SUPERIORITY|Note: The study was not powered a priori to detect significant differences in these outcomes.|Partial Eta Squared|0.0||||0.98|TWO_SIDED|90.0|0.0|0.0|||ANCOVA|Controlling for pre-vaccination levels||A/Michigan 16 weeks post-vaccination||.000|.000|.980
72443392|NCT03144518|144400092|SUPERIORITY|Note: The study was not powered a priori to detect significant differences in these outcomes.|Partial Eta Squared|0.007||||0.409|TWO_SIDED|90.0|0.0|0.057|||ANCOVA|Controlling for pre-vaccination levels||B/Brisbane 4 weeks post-vaccination||.057|.000|.409
72443393|NCT03144518|144400092|SUPERIORITY|Note: The study was not powered a priori to detect significant differences in these outcomes.|Partial Eta Squared|0.008||||0.377|TWO_SIDED|90.0|0.0|0.062|||ANCOVA|Controlling for pre-vaccination levels||B/Brisbane 16 weeks post-vaccination||.062|.000|.377
72443394|NCT03144518|144400092|SUPERIORITY||Partial Eta Squared|0.0||||0.892|TWO_SIDED|90.0|0.0|0.008|||ANCOVA|Controlling for pre-vaccination levels||B/Phuket 4 weeks post-vaccination||.008|.000|.892
72443395|NCT03144518|144400092|SUPERIORITY|Note: The study was not powered a priori to detect significant differences in these outcomes.|Partial Eta Squared|0.007||||0.426|TWO_SIDED|90.0|0.0|0.058|||ANCOVA|Controlling for pre-vaccination levels||||.058|.000|.426
72443396|NCT01989455|144400100|SUPERIORITY_OR_OTHER||Percent ratio|73.19|||||TWO_SIDED|90.0|68.83|77.56||||||||77.56|68.83|
72443397|NCT00448669|144400102|SUPERIORITY_OR_OTHER_LEGACY|||||||0.003|TWO_SIDED||||||Regression, Cox|||Safety analyses were performed in the intention-to-treat cohort. Primary safety end points included the frequency of adverse clinical or laboratory events.||||0.003
72443398|NCT00448669|144400103|SUPERIORITY_OR_OTHER_LEGACY||Efficacy|62.2||||0.03|TWO_SIDED|95.0|21.5|83.4|||Regression, Cox|||The primary efficacy end point was the difference in the rates of HIV infection between participants assigned to receive TDF-FTC and those assigned to receive placebo. The primary hypothesis was that TDF-FTC, as compared with placebo, would reduce the rate of HIV infection by at least 65%, with a predefined lower boundary for the 95% confidence interval of 10%.||83.4|21.5|0.03
72443399|NCT00448669|144400104|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.16||||0.004|TWO_SIDED|95.0|1.05|1.28|||Regression, Logistic|In this univariate model with the analysis of number of condomless sex acts, our model estimates the odds of reporting no condomless sex acts.||"A logistic regression was used to estimate the odds of reporting zero condomless sex acts. The longitudinal dependent variable (number of condomless sex acts) was defined as:~Number of condomless vaginal sexual acts with both casual and main partners among those who reported having had at least one sexual partner in the previous 30 days."||1.28|1.05|0.004
72560058|NCT01139762|144650653|SUPERIORITY_OR_OTHER||LS Mean Difference|0.68|||<|0.001|TWO_SIDED|95.0|0.43|0.93||P-value is for Question 3 - 12 weeks.|Mixed Model Repeated Measures Analysis|The Kenward-Roger approximation was used to estimate denominator degrees of freedom.||MMRM model includes treatment, region, visit, and treatment-by-visit interaction as fixed effects, and subject as a random effect. Baseline IIEF was the covariate. No imputation of missing IIEF data was performed. The within-subject errors were modeled using an unstructured covariance structure.||0.93|0.43|<0.001
72388701|NCT02100514|144285703|SUPERIORITY_OR_OTHER||LS mean difference compared to placebo|5.4|STANDARD_ERROR_OF_MEAN|1.14||||95.0|3.2|7.6||||||Week 24: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||7.6|3.2|
72388702|NCT02100514|144285703|SUPERIORITY_OR_OTHER||LS mean difference compared to placebo|6.0|STANDARD_ERROR_OF_MEAN|1.2||||95.0|3.6|8.3||||||Week 52: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||8.3|3.6|
72388703|NCT02100514|144285704|SUPERIORITY_OR_OTHER||LS mean difference compared to placebo|-44.2|STANDARD_ERROR_OF_MEAN|2.39||||95.0|-48.8|-39.5||||||Week 24: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-39.5|-48.8|
72388704|NCT02100514|144285704|SUPERIORITY_OR_OTHER||LS mean difference compared to placebo|-36.2|STANDARD_ERROR_OF_MEAN|2.42|||TWO_SIDED|95.0|-40.9|-31.4||||||Week 52: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-31.4|-40.9|
72388705|NCT02100514|144285705|SUPERIORITY_OR_OTHER||LS mean difference compared to placebo|-10.1|STANDARD_ERROR_OF_MEAN|2.55||||95.0|-15.1|-5.1||||||Week 12: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-5.1|-15.1|
72388706|NCT02100514|144285705|SUPERIORITY_OR_OTHER||LS mean difference compared to placebo|-9.0|STANDARD_ERROR_OF_MEAN|4.5||||95.0|-17.9|-0.2||||||Week 24: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-0.2|-17.9|
72388707|NCT02100514|144285705|SUPERIORITY_OR_OTHER||LS mean difference compared to placebo|-8.2|STANDARD_ERROR_OF_MEAN|3.04||||95.0|-14.1|-2.2||||||Week 52: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-2.2|-14.1|
72388708|NCT02100514|144285706|SUPERIORITY_OR_OTHER||LS mean difference compared to placebo|4.1|STANDARD_ERROR_OF_MEAN|0.85||||95.0|2.5|5.8||||||Week 12: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||5.8|2.5|
72388709|NCT02100514|144285706|SUPERIORITY_OR_OTHER||LS mean difference compared to placebo|3.8|STANDARD_ERROR_OF_MEAN|0.86||||95.0|2.2|5.5||||||Week 24: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||5.5|2.2|
72388710|NCT02100514|144285706|SUPERIORITY_OR_OTHER||LS mean difference compared to placebo|4.3|STANDARD_ERROR_OF_MEAN|0.97||||95.0|2.4|6.2||||||Week 52: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||6.2|2.4|
72388711|NCT02100514|144285707|SUPERIORITY_OR_OTHER||LS mean difference compared to placebo|1.1|STANDARD_ERROR_OF_MEAN|0.9||||95.0|-0.7|2.8||||||Week 12: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||2.8|-0.7|
72388712|NCT02100514|144285707|SUPERIORITY_OR_OTHER||LS mean difference compared to placebo|0.9|STANDARD_ERROR_OF_MEAN|1.04||||95.0|-1.1|3.0||||||Week 24: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||3.0|-1.1|
72388713|NCT02100514|144285707|SUPERIORITY_OR_OTHER||LS mean difference compared to placebo|0.8|STANDARD_ERROR_OF_MEAN|0.95||||95.0|-1.0|2.7||||||Week 52: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||2.7|-1.0|
72388714|NCT02100514|144285708|SUPERIORITY_OR_OTHER||LS mean difference compared to placebo|-10.1|STANDARD_ERROR_OF_MEAN|2.55||||95.0|-15.1|-5.1||||||Week 12: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-5.1|-15.1|
72622385|NCT00855166|144774677|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.08|STANDARD_ERROR_OF_MEAN|0.3885|<|0.0001|TWO_SIDED|95.0|-2.84|-1.31||Significant at alpha=0.05 (2-sided)|ANCOVA|with treatment group and stratum (gender) as effects and baseline value as covariate||H0: mean(treat) minus mean(placebo) = 0 versus the alternative HA: mean(treat) minus mean(placebo) =/= 0||-1.31|-2.84|<0.0001
72388715|NCT02100514|144285708|SUPERIORITY_OR_OTHER||LS mean difference compared to placebo|-9.0|STANDARD_ERROR_OF_MEAN|4.5||||95.0|-17.9|-0.2||||||Week 24: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-0.2|-17.9|
72496896|NCT03932799|144523270|SUPERIORITY|Adjusted for same covariates as primary outcomes, plus survey-based covariates: days from injury to baseline survey date, education, household income, race/ethnicity, working for pay, recovery expectations, anxious symptoms, depressive symptoms, pre-injury opioid, chiropractic and PT utilization during baseline period/acute phase, cannabis for injury pain, alcohol misuse risk, current tobacco use, pain intensity/interference, Functional Comorbidity Index, health status, and quality of life.|beta|0.22||||0.01|TWO_SIDED|95.0|0.05|0.38||"* two-tailed test~* p-values \< 0.05 are statistically significant"|Regression, Logistic|||"* Primary predictor is binary (1 for Washington, 0 for Ohio)~* Models survey weighted~* Robust variance estimates"||0.38|0.05|.01
72496897|NCT03932799|144523271|SUPERIORITY|Adjusted for same covariates as primary outcomes, plus survey-based covariates: days from injury to baseline survey date, education, household income, race/ethnicity, working for pay, recovery expectations, anxious symptoms, depressive symptoms, pre-injury opioid, chiropractic and PT utilization during baseline period/acute phase, cannabis for injury pain, alcohol misuse risk, current tobacco use, pain intensity/interference, Functional Comorbidity Index, health status, and quality of life.|Odds Ratio (OR)|0.76||||0.35|TWO_SIDED|95.0|0.42|1.35||"* two-tailed test~* p-values \< 0.05 are statistically significant"|Regression, Logistic|||"* Primary predictor is binary (1 for Washington, 0 for Ohio)~* Models survey weighted~* Robust variance estimates"||1.35|0.42|.35
72496898|NCT01097629|144523294|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Means|26.3|||<|1e-05|TWO_SIDED|95.0|18.3|34.3||By multiplicity strategy above, overall Type I error among primary hypotheses was controlled at two-sided 5% significance level.|Longitudinal Data Analysis|Model terms: baseline value, age group, region, gender, treatment, time, time by treatment interaction, and cohort (e-diary only, PSG-plus-e-diary).||The null hypothesis, that suvorexant HD did not differ from placebo for Month 1 sTSTm, had planned marginal power of 97.6%. Sleep maintenance (sTSTm, WASO) and sleep onset (sTSOm, LPS) endpoints were tested at two-sided 2.5% significance level. Both Month 1 endpoints for sleep maintenance must be significant to test Month 3 endpoints; the same approach was used for sleep onset endpoints.||34.3|18.3|<0.00001
72496899|NCT01097629|144523295|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Means|25.1|||<|1e-05||95.0|16.0|34.2||By multiplicity strategy above, overall Type I error among primary hypotheses was controlled at two-sided 5% significance level.|Longitudinal Data Analysis|Model terms: baseline value, age group, region, gender, treatment, time, time by treatment interaction, and cohort (e-diary only, PSG-plus-e-diary).||The null hypothesis, that suvorexant HD did not differ from placebo for Month 3 sTSTm, had planned marginal power of 95.7%. Sleep maintenance (sTSTm, WASO) and sleep onset (sTSOm, LPS) endpoints were tested at two-sided 2.5% significance level. Both Month 1 endpoints for sleep maintenance must be significant to test Month 3 endpoints; the same approach was used for sleep onset endpoints.||34.2|16.0|<0.00001
72496900|NCT01097629|144523296|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Means|-29.4|||<|1e-05|TWO_SIDED|95.0|-36.6|-22.3||By multiplicity strategy above, overall Type I error among primary hypotheses was controlled at two-sided 5% significance level.|Longitudinal Data Analysis|Model terms: baseline value, age group, region, gender, treatment, time, and time by treatment interaction.||The null hypothesis, that suvorexant HD did not differ from placebo for Month 1 WASO, had planned marginal power of 99.2%. Sleep maintenance (sTSTm, WASO) and sleep onset (sTSOm, LPS) endpoints were tested at two-sided 2.5% significance level. Both Month 1 endpoints for sleep maintenance must be significant to test Month 3 endpoints; the same approach was used for sleep onset endpoints.||-22.3|-36.6|<0.00001
72496901|NCT01097629|144523297|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Means|-29.4|||<|1e-05|TWO_SIDED|95.0|-36.7|-22.1||By multiplicity strategy above, overall Type I error among primary hypotheses was controlled at two-sided 5% significance level.|Longitudinal Data Analysis|Model terms: baseline value, age group, region, gender, treatment, time, and time by treatment interaction.||The null hypothesis, that suvorexant HD did not differ from placebo for Month 3 WASO, had planned marginal power of 98.3%. Sleep maintenance (sTSTm, WASO) and sleep onset (sTSOm, LPS) endpoints were tested at two-sided 2.5% significance level. Both Month 1 endpoints for sleep maintenance must be significant to test Month 3 endpoints; the same approach was used for sleep onset endpoints.||-22.1|-36.7|<0.00001
72496902|NCT01097629|144523298|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Means|-12.8||||3e-05|TWO_SIDED|95.0|-18.8|-6.9||By multiplicity strategy above, overall Type I error among primary hypotheses was controlled at two-sided 5% significance level.|Longitudinal Data Analysis|Model terms: baseline value, age group, region, gender, treatment, time, time by treatment interaction, and cohort (e-diary only, PSG-plus-e-diary).||The null hypothesis, that suvorexant HD did not differ from placebo for Month 1 sTSOm, had planned marginal power of 99.9%. Sleep maintenance (sTSTm, WASO) and sleep onset (sTSOm, LPS) endpoints were tested at two-sided 2.5% significance level. Both Month 1 endpoints for sleep maintenance must be significant to test Month 3 endpoints; the same approach was used for sleep onset endpoints.||-6.9|-18.8|0.00003
72622386|NCT00855166|144774678|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.52|STANDARD_ERROR_OF_MEAN|0.6162||0.0143|TWO_SIDED|95.0|-2.74|-0.31||Significant at alpha=0.05 (2-sided). Results of key secondary endpoints are interpreted using Hochberg's method|ANCOVA|with treatment group and stratum (gender) as effects and baseline value as covariate||H0: mean(treat) minus mean(placebo) = 0 versus the alternative HA: mean(treat) minus mean(placebo) =/= 0||-0.31|-2.74|0.0143
72388716|NCT02100514|144285708|SUPERIORITY_OR_OTHER||LS mean difference compared to placebo|-8.2|STANDARD_ERROR_OF_MEAN|3.04||||95.0|-14.1|-2.2||||||Week 52: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-2.2|-14.1|
72388717|NCT02100514|144285709|SUPERIORITY_OR_OTHER||LS mean difference compared to placebo|-66.8|STANDARD_ERROR_OF_MEAN|3.18||||95.0|-73.0|-60.5||||||LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region. An unstructured variance covariance matrix was used.||-60.5|-73.0|
72443400|NCT00448669|144400105|SUPERIORITY_OR_OTHER_LEGACY|||||||0.79|||||||Fisher Exact|||Fisher's Exact Test was performed to test for differences between the treatment groups in terms of adherence based on pill count.||||0.79
72443401|NCT02395978|144400118|SUPERIORITY|||||||0.393|||||||Kruskal-Wallis|||||||0.393
72443402|NCT03338816|144400134|SUPERIORITY||Rate ratio|0.26|||<|0.0001|TWO_SIDED|95.0|0.16|0.41||P=6.040E-09|Negative binomial regression model|||Negative binomial regression model with treatment group and stratification factors (prior hemin prophylaxis status and historical attack rates) as fixed effects and the logarithm of the follow-up time as an offset variable.||0.41|0.16|<0.0001
72443403|NCT03833167|144400168|SUPERIORITY||Hazard Ratio (HR)|0.76||||0.07243|TWO_SIDED|95.0|0.53|1.1||One-sided p-value based on log-rank test stratified by baseline Extracapsular extension (yes versus no) and Cortical bone invasion (yes versus no) with small strata collapsed.|Log Rank||Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by baseline Extracapsular extension (yes versus no) and Cortical bone invasion (yes versus no) with small strata collapsed.|||1.10|0.53|0.07243
72443404|NCT03833167|144400169|SUPERIORITY||Hazard Ratio (HR)|1.47|||||TWO_SIDED|95.0|0.87|2.48|||||Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by baseline Extracapsular extension (yes versus no) and Cortical bone invasion (yes versus no) with small strata collapsed.|||2.48|0.87|
72496903|NCT01097629|144523299|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Means|-13.2||||3e-05|TWO_SIDED|95.0|-19.4|-7.0||By multiplicity strategy above, overall Type I error among primary hypotheses was controlled at two-sided 5% significance level.|Longitudinal Data Analysis|Model terms: baseline value, age group, region, gender, treatment, time, time by treatment interaction, and cohort (e-diary only, PSG-plus-e-diary).||The null hypothesis, that suvorexant HD did not differ from placebo for Month 3 sTSOm, had planned marginal power of 99.6%. Sleep maintenance (sTSTm, WASO) and sleep onset (sTSOm, LPS) endpoints were tested at two-sided 2.5% significance level. Both Month 1 endpoints for sleep maintenance must be significant to test Month 3 endpoints; the same approach was used for sleep onset endpoints.||-7.0|-19.4|0.00003
72496904|NCT01097629|144523300|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Means|-12.1||||4e-05|TWO_SIDED|95.0|-17.8|-6.4||By multiplicity strategy above, overall Type I error among primary hypotheses was controlled at two-sided 5% significance level.|Longitudinal Data Analysis|Model terms: baseline value, age group, region, gender, treatment, time, and time by treatment interaction.||The null hypothesis, that suvorexant HD did not differ from placebo for Month 1 LPS, had planned marginal power of 81.4%. Sleep maintenance (sTSTm, WASO) and sleep onset (sTSOm, LPS) endpoints were tested at two-sided 2.5% significance level. Both Month 1 endpoints for sleep maintenance must be significant to test Month 3 endpoints; the same approach was used for sleep onset endpoints.||-6.4|-17.8|0.00004
72496905|NCT01097629|144523301|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Means|-3.6||||0.2651|TWO_SIDED|95.0|-10.1|2.8||By multiplicity strategy above, overall Type I error among primary hypotheses was controlled at two-sided 5% significance level.|Longitudinal Data Analysis|Model terms: baseline value, age group, region, gender, treatment, time, and time by treatment interaction.||The null hypothesis, that suvorexant HD did not differ from placebo for Month 3 LPS, had planned marginal power of 76.2%. Sleep maintenance (sTSTm, WASO) and sleep onset (sTSOm, LPS) endpoints were tested at two-sided 2.5% significance level. Both Month 1 endpoints for sleep maintenance must be significant to test Month 3 endpoints; the same approach was used for sleep onset endpoints.||2.8|-10.1|0.26510
72496906|NCT01097629|144523302|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Means|26.4|||<|1e-05|TWO_SIDED|95.0|19.8|33.1|||Longitudinal Data Analysis|Model terms: baseline value, age group, region, gender, treatment, time, time by treatment interaction, and cohort (e-diary only, PSG-plus-e-diary).||The null hypothesis, that suvorexant HD did not differ from placebo for Week 1 sTSTm, had planned marginal power of 98.3%. Sleep maintenance (sTSTm, WASO) and sleep onset (sTSOm, LPS) endpoints were tested at two-sided 2.5% significance level. Both Month 1 endpoints for sleep maintenance must be significant to test Month 3 endpoints and either subjective or objective Month 3 endpoint must be significant to test Week 1/Night 1 endpoints. The same approach was used for sleep onset endpoints.||33.1|19.8|<0.00001
72504696|NCT01709799|144540121|SUPERIORITY_OR_OTHER|||||||0.313|TWO_SIDED|||||P-value is not adjusted for multiple comparisons, and p \< .05 is the a priori threshold for statistical significance|Mixed Models Analysis|degrees of freedom are (4,93.167)||Occasion by arm interaction. Null hypothesis of no group differences in improvement (Interaction has p-value \> .05)||||0.313
72443405|NCT03833167|144400170|SUPERIORITY||Mean Difference (Final Values)|-3.41||||0.2227|TWO_SIDED|95.0|-8.91|2.09||Based on a cLDA model with the PRO scores as the response variable with covariates for treatment by study visit interaction, and stratification factors by Extracapsular extension, Cortical bone invasion, and Prior systemic therapy.|Log Rank||Based on a cLDA model with the PRO scores as the response variable with covariates for treatment by study visit interaction, and stratification factors by Extracapsular extension, Cortical bone invasion, and Prior systemic therapy.|||2.09|-8.91|0.2227
72443406|NCT03833167|144400171|SUPERIORITY||Mean Difference (Final Values)|-2.89||||0.1874|TWO_SIDED|95.0|-7.19|1.42||Based on a cLDA model with the PRO scores as the response variable with covariates for treatment by study visit interaction, and stratification factors by Extracapsular extension, Cortical bone invasion, and Prior systemic therapy.|Log Rank||Based on a cLDA model with the PRO scores as the response variable with covariates for treatment by study visit interaction, and stratification factors by Extracapsular extension, Cortical bone invasion, and Prior systemic therapy.|||1.42|-7.19|0.1874
72443407|NCT02272816|144400208|OTHER||Percentage|95.6|||||ONE_SIDED|95.0||98.6||||||||98.6||
72443408|NCT02272816|144400209|OTHER||Percentage|45.0|||||TWO_SIDED|95.0|30.2|59.9||||||||59.9|30.2|
72443409|NCT02272816|144400210|OTHER||Percentage|100.0|||||TWO_SIDED|95.0|92.6|100.0||||||||100|92.6|
72443410|NCT00709098|144400223|SUPERIORITY_OR_OTHER||Mean group difference|-5.1|||<|0.0001|TWO_SIDED|95.0|-7.0|-3.1|||t-test, 2 sided|||||-3.1|-7.0|<0.0001
72443411|NCT03690206|144400262|SUPERIORITY||Difference to Placebo|-2.28||||0.0039|TWO_SIDED|95.0|-3.83|-0.73|||Mixed Models Analysis|||||-0.73|-3.83|0.0039
72443412|NCT03690206|144400262|SUPERIORITY||Difference to Placebo|-0.91||||0.27|TWO_SIDED|95.0|-2.52|0.71|||Mixed Models Analysis|||||0.71|-2.52|0.2700
72443413|NCT03690206|144400263|SUPERIORITY||Difference to Placebo|26.6||||0.0243|TWO_SIDED|95.0|4.3|48.9|||Cochran-Mantel-Haenszel|||||48.9|4.3|0.0243
72560059|NCT01139762|144650653|SUPERIORITY_OR_OTHER||LS Mean Difference|0.75|||<|0.001|TWO_SIDED|95.0|0.48|1.02||P-value is for Question 3 - 26 weeks.|Mixed Model Repeated Measures Analysis|The Kenward-Roger approximation was used to estimate denominator degrees of freedom.||MMRM model includes treatment, region, visit, and treatment-by-visit interaction as fixed effects, and subject as a random effect. Baseline IIEF was the covariate. No imputation of missing IIEF data was performed. The within-subject errors were modeled using an unstructured covariance structure.||1.02|0.48|<0.001
72560060|NCT01139762|144650653|SUPERIORITY_OR_OTHER||LS Mean Difference|0.71|||<|0.001|TWO_SIDED|95.0|0.46|0.95||P-value is for Question 4 - 4 weeks.|Mixed Model Repeated Measures Analysis|The Kenward-Roger approximation was used to estimate denominator degrees of freedom.||MMRM model includes treatment, region, visit, and treatment-by-visit interaction as fixed effects, and subject as a random effect. Baseline IIEF was the covariate. No imputation of missing IIEF data was performed. The within-subject errors were modeled using an unstructured covariance structure.||0.95|0.46|<0.001
72560061|NCT01139762|144650653|SUPERIORITY_OR_OTHER||LS Mean Difference|0.61|||<|0.001|TWO_SIDED|95.0|0.36|0.85||P-value is for Question 4 - 12 weeks.|Mixed Model Repeated Measures Analysis|The Kenward-Roger approximation was used to estimate denominator degrees of freedom.||MMRM model includes treatment, region, visit, and treatment-by-visit interaction as fixed effects, and subject as a random effect. Baseline IIEF was the covariate. No imputation of missing IIEF data was performed. The within-subject errors were modeled using an unstructured covariance structure.||0.85|0.36|<0.001
72622387|NCT00855166|144774679|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.48|STANDARD_ERROR_OF_MEAN|0.3731||0.0001|TWO_SIDED|95.0|-2.22|-0.74||Significant at alpha=0.05 (2-sided). Results of key secondary endpoints are interpreted using Hochberg's method|ANCOVA|with treatment group and stratum (gender) as effects and baseline value as covariate||H0: mean(treat) minus mean(placebo) = 0 versus the alternative HA: mean(treat) minus mean(placebo) =/= 0||-0.74|-2.22|0.0001
72443414|NCT03690206|144400263|SUPERIORITY||Difference to Placebo|5.5||||0.6255|TWO_SIDED|95.0|-16.2|27.1|||Cochran-Mantel-Haenszel|||||27.1|-16.2|0.6255
72443415|NCT03690206|144400264|SUPERIORITY||Difference to Placebo|31.7||||0.0043|TWO_SIDED|95.0|11.4|51.9|||Cochran-Mantel-Haenszel|||||51.9|11.4|0.0043
72443416|NCT03690206|144400264|SUPERIORITY||Difference to Placebo|13.3||||0.1675|TWO_SIDED|95.0|-5.4|32.0|||Cochran-Mantel-Haenszel|||||32.0|-5.4|0.1675
72443417|NCT03690206|144400266|SUPERIORITY||Difference to Placebo|14.1||||0.016|TWO_SIDED|95.0|2.5|25.6|||Cochran-Mantel-Haenszel|||||25.6|2.5|0.0160
72443418|NCT03690206|144400266|SUPERIORITY||Difference to Placebo|11.2||||0.0424|TWO_SIDED|95.0|0.7|21.6|||Cochran-Mantel-Haenszel|||||21.6|0.7|0.0424
72443419|NCT04567615|144400294|SUPERIORITY||Strata adjusted difference in ORR|-2.7|||||TWO_SIDED|95.0|-10.7|5.3|||||Difference in ORR of Treatment B over ORR Treatment A|||5.3|-10.7|
72443420|NCT04567615|144400297|SUPERIORITY||Cox proportional hazard model|1.0|||||TWO_SIDED|95.0|0.75|1.33|||||HR of Treatment B over HR Treatment A|||1.33|0.75|
72443421|NCT04567615|144400298|SUPERIORITY||Strata adjusted difference in ORR|-0.9|||||TWO_SIDED|95.0|-9.2|7.4|||||Difference in ORR of Treatment B over ORR Treatment A|||7.4|-9.2|
72443422|NCT04567615|144400301|SUPERIORITY||Cox proportional hazard model|1.0|||||TWO_SIDED|95.0|0.75|1.33|||||HR of Treatment B over HR of Treatment A|||1.33|0.75|
72443423|NCT04567615|144400302|SUPERIORITY||Cox proportional hazard model|1.05|||||TWO_SIDED|95.0|0.74|1.49|||||HR of Treatment B over HR of Treatment A|||1.49|0.74|
72443424|NCT03012841|144400320|SUPERIORITY|The formal alternative hypothesis test for the primary effectiveness objective was that the Kaplan-Meier estimator of treatment success at 12 months (365 days) was greater than 40%, against the null hypothesis that it was less than or equal to 40%.|Kaplan-Meier (product-limit) estimator|54.8|||<|0.001|TWO_SIDED|95.0|46.7|62.1|||Exact binomial|Exact binomial p-value is shown, but the confidence intervals reported are calculated from Greenwood's approximation of the standard error.||||62.1|46.7|<0.001
72443425|NCT03012841|144400321|SUPERIORITY|The formal alternative hypothesis tested for the primary safety objective was that the Kaplan-Meier estimator of the proportion of subjects with primary safety events at 12 months (365 days) was less than 13%, against the null hypothesis that it was greater than or equal to 13%.|Kaplan-Meier (product-limit) estimator|0.6||||0.002|TWO_SIDED|95.0|0.1|4.4|||Exact binomial|Exact binomial p-value is shown, but the confidence intervals reported are calculated from Greenwood's approximation of the standard error.||||4.4|0.1|0.002
72443426|NCT03012841|144400322|SUPERIORITY||Mean Difference (Net)|25.8|||<|0.001|TWO_SIDED|95.0|22.1|29.5||A Hommel multiple testing procedure was utilized to maintain overall alpha of 0.025 for the 3 hypotheses tested for the secondary objective.|t-test, 1 sided|||The formal alternative hypothesis tested was that the mean 12-month change in AFEQT composite scores was greater than 0, against the null the hypothesis that it was equal to 0.||29.5|22.1|<0.001
72443427|NCT03012841|144400323|SUPERIORITY||Mean Difference (Net)|5.0|||<|0.001|TWO_SIDED|95.0|3.5|6.5||A Hommel multiple testing procedure was utilized to maintain overall alpha of 0.025 for the 3 hypotheses tested for the secondary objective.|t-test, 1 sided|||The formal alternative hypothesis tested was that the mean 12-month change in SF-12 physical composite scores was greater than 0, against the null the hypothesis that it was equal to 0.||6.5|3.5|<0.001
72443428|NCT03012841|144400324|SUPERIORITY||Mean Difference (Net)|4.9|||<|0.001|TWO_SIDED|95.0|3.2|6.6||A Hommel multiple testing procedure was utilized to maintain overall alpha of 0.025 for the 3 hypotheses tested for the secondary objective.|t-test, 1 sided|||The formal alternative hypothesis tested was that the mean 12-month change in SF-12 mental composite scores was greater than 0, against the null the hypothesis that it was equal to 0.||6.6|3.2|<0.001
72443429|NCT04491968|144400325|SUPERIORITY||Hazard Ratio (HR)|0.58||||0.02|TWO_SIDED|95.0|0.37|0.9|||proportional hazard regression|||||.90|.37|.02
72443430|NCT04491968|144400326|SUPERIORITY||Hazard Ratio (HR)|0.41||||0.04|TWO_SIDED|95.0|0.18|0.96|||proportional hazard regression|||||.96|.18|.04
72443431|NCT02396199|144400371|SUPERIORITY||Proportion of participants|0.917||||0.006|ONE_SIDED|95.0|0.827|||One-sided test|Fisher Exact||Exact test, One-sided 95%, with lower limit (0.827)||||0.827|0.006
72443432|NCT02721381|144400375|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||The effect of group assignment was examined using MLM, with a significant time X group interaction indicative of an effect of group assignment. Data from T1, T2, and T3 were both used in same analysis.||||<.001
72496907|NCT01097629|144523303|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Means|-42.0|||<|1e-05|TWO_SIDED|95.0|-48.6|-35.3|||Longitudinal Data Analysis|Model terms: baseline value, age group, region, gender, treatment, time, and time by treatment interaction.||The null hypothesis, that suvorexant HD did not differ from placebo for Night 1 WASO, had planned marginal power of 100.0%. Sleep maintenance (sTSTm, WASO) and sleep onset (sTSOm, LPS) endpoints were tested at two-sided 2.5% significance level. Both Month 1 endpoints for sleep maintenance must be significant to test Month 3 endpoints and either subjective or objective Month 3 endpoint must be significant to test Week 1/Night 1 endpoints. The same approach was used for sleep onset endpoints.||-35.3|-48.6|<0.00001
72560062|NCT01139762|144650653|SUPERIORITY_OR_OTHER||LS Mean Difference|0.62|||<|0.001|TWO_SIDED|95.0|0.35|0.89||P-value is for Question 4 - 26 weeks.|Mixed Model Repeated Measures Analysis|The Kenward-Roger approximation was used to estimate denominator degrees of freedom.||MMRM model includes treatment, region, visit, and treatment-by-visit interaction as fixed effects, and subject as a random effect. Baseline IIEF was the covariate. No imputation of missing IIEF data was performed. The within-subject errors were modeled using an unstructured covariance structure.||0.89|0.35|<0.001
72388718|NCT02100514|144285710|SUPERIORITY_OR_OTHER||LS mean difference compared to placebo|-66.1|STANDARD_ERROR_OF_MEAN|5.4||||95.0|-76.7|-55.4||||||LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region. An unstructured variance covariance matrix was used.||-55.4|-76.7|
72388719|NCT02100514|144285711|SUPERIORITY_OR_OTHER||LS mean difference compared to placebo|-66.5|STANDARD_ERROR_OF_MEAN|2.77||||95.0|-72.0|-61.1||||||LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-61.1|-72.0|
72388720|NCT02100514|144285712|SUPERIORITY_OR_OTHER||LS mean difference compared to placebo|-69.1|STANDARD_ERROR_OF_MEAN|3.08||||95.0|-75.2|-63.1||||||LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-63.1|-75.2|
72388721|NCT02100514|144285713|SUPERIORITY_OR_OTHER||LS mean difference compared to placebo|-71.3|STANDARD_ERROR_OF_MEAN|3.14||||95.0|-77.5|-65.1||||||LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-65.1|-77.5|
72388722|NCT02100514|144285714|SUPERIORITY_OR_OTHER||LS mean difference compared to placebo|-47.7|STANDARD_ERROR_OF_MEAN|2.12||||95.0|-51.9|-43.6||||||LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-43.6|-51.9|
72388723|NCT02100514|144285715|SUPERIORITY_OR_OTHER||LS mean difference compared to placebo|-10.4|STANDARD_ERROR_OF_MEAN|1.06||||95.0|-12.5|-8.3||||||LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-8.3|-12.5|
72388724|NCT02100514|144285716|SUPERIORITY_OR_OTHER||LS mean difference compared to placebo|2.6|STANDARD_ERROR_OF_MEAN|0.52||||95.0|1.6|3.6||||||LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||3.6|1.6|
72388725|NCT02100514|144285717|SUPERIORITY_OR_OTHER||LS mean difference compared to placebo|-1.6|STANDARD_ERROR_OF_MEAN|0.08||||95.0|-1.8|-1.5||||||Week 12: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-1.5|-1.8|
72388726|NCT02100514|144285717|SUPERIORITY_OR_OTHER||LS mean difference compared to placebo|-1.4|STANDARD_ERROR_OF_MEAN|0.1||||95.0|-1.6|-1.3||||||Week 24: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-1.3|-1.6|
72388727|NCT02100514|144285717|SUPERIORITY_OR_OTHER||LS mean difference compared to placebo|-1.4|STANDARD_ERROR_OF_MEAN|0.12||||95.0|-1.6|-1.2||||||Week 52: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-1.2|-1.6|
72388728|NCT02100514|144285718|SUPERIORITY_OR_OTHER||LS mean difference compared to placebo|-0.4|STANDARD_ERROR_OF_MEAN|0.02||||95.0|-0.4|-0.3||||||Week 12: LS mean difference and associated 95% confidence interval CI were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-0.3|-0.4|
72388729|NCT02100514|144285718|SUPERIORITY_OR_OTHER||LS mean difference compared to placebo|-0.3|STANDARD_ERROR_OF_MEAN|0.02||||95.0|-0.3|-0.3||||||Week 24: LS mean difference and associated 95% confidence interval CI were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-0.3|-0.3|
72560063|NCT02614196|144650654|SUPERIORITY||LSMean Difference|-2.02|STANDARD_ERROR_OF_MEAN|0.27|<|0.001|TWO_SIDED|95.0|-2.55|-1.48|||Mixed Models Analysis|||||-1.48|-2.55|<.001
72560064|NCT02614196|144650654|SUPERIORITY||LSMean Difference|-1.9|STANDARD_ERROR_OF_MEAN|0.27|<|0.001|TWO_SIDED|95.0|-2.44|-1.36|||Mixed Models Analysis|||||-1.36|-2.44|<.001
72560065|NCT02614196|144650655|SUPERIORITY||Odds Ratio (OR)|2.6|||||TWO_SIDED|95.0|2.03|3.32||||||Reduction from Baseline ≥50%||3.32|2.03|
72496908|NCT01097629|144523304|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Means|-13.1|||<|1e-05|TWO_SIDED|95.0|-17.7|-8.4|||Longitudinal Data Analysis|Model terms: baseline value, age group, region, gender, treatment, time, time by treatment interaction, and cohort (e-diary only, PSG-plus-e-diary).||The null hypothesis, that suvorexant HD did not differ from placebo for Week 1 sTSOm, had planned marginal power of 99.6%. Sleep maintenance (sTSTm, WASO) and sleep onset (sTSOm, LPS) endpoints were tested at two-sided 2.5% significance level. Both Month 1 endpoints for sleep maintenance must be significant to test Month 3 endpoints and either subjective or objective Month 3 endpoint must be significant to test Week 1/Night 1 endpoints. The same approach was used for sleep onset endpoints.||-8.4|-17.7|<0.00001
72496909|NCT01097629|144523305|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Means|-21.7|||<|1e-05|TWO_SIDED|95.0|-28.6|-14.9|||Longitudinal Data Analysis|Model terms: baseline value, age group, region, gender, treatment, time, and time by treatment interaction.||The null hypothesis, that suvorexant HD did not differ from placebo for Night 1 LPS, had planned marginal power of 100.0%. Sleep maintenance (sTSTm, WASO) and sleep onset (sTSOm, LPS) endpoints were tested at two-sided 2.5% significance level. Both Month 1 endpoints for sleep maintenance must be significant to test Month 3 endpoints and either subjective or objective Month 3 endpoint must be significant to test Week 1/Night 1 endpoints. The same approach was used for sleep onset endpoints.||-14.9|-28.6|<0.00001
72496910|NCT00132041|144523315|OTHER||Success rate|0.18|||||TWO_SIDED|95.0|0.091|0.317|||||logistic regression model without correcting for the clustering effect|logistic regression was used to estimate the success rate||0.317|0.091|
72496911|NCT00132041|144523315|OTHER||Success rate|0.19|||||TWO_SIDED|95.0|0.136|0.252||||||logistic regression model after specifying site as cluster (using GEE approach).||0.252|0.136|
72496912|NCT00132041|144523316|OTHER||Success rate|0.18|||||TWO_SIDED|95.0|0.091|0.317|||||logistic regression model without correcting for the clustering effect|logistic regression was used to estimate the success rate||0.317|0.091|
72496913|NCT00132041|144523316|OTHER||Slope|-3.7913||||0.0004|TWO_SIDED|95.0|-5.9056|-1.6769|||Generlaized estimating equations|Multivariate logistic model. P-value for number of RFA sessions dichotomized 1: more than 1; using the latter as the reference.|This estimate is for the effect of a single RFA sessions (v multiple sessions) in the multivariate model response:18 mo success/failure; covariates: tumor size,repeated RFA, local tumor recurrence, remote tumor occurrence, and age and gender.|multivariate logistic regression model was fit using GEEs to correct for site clustering effects, in which, the response variable was success/failure at 18 months and the covariates were tumor size, whether or not a patient received repeated RFA, whether or not a local tumor recurrence occurred, whether or not a remote tumor occurrence occurred, and two common confounding factors - age and gender||-1.6769|-5.9056|0.0004
72560066|NCT02614196|144650655|SUPERIORITY||Odds Ratio (OR)|2.31|||||TWO_SIDED|95.0|1.81|2.96||||||Reduction from Baseline ≥50%||2.96|1.81|
72560067|NCT02614196|144650655|SUPERIORITY||Odds Ratio (OR)|2.34|||||TWO_SIDED|95.0|1.78|3.06||||||Reduction from Baseline ≥75%||3.06|1.78|
72496914|NCT00132041|144523317|OTHER||GEE|-0.9101||||0.0221|TWO_SIDED|95.0|-1.6894|-0.1308|||Generlaized Estimating Equations|multivariate GEE model using logistic link|Estimation parameter is for tumor size when controlling for other covariates.|Effect of tumor size in the multivariate model with response:18 mo success/failure; covariates: tumor size,repeated RFA, local tumor recurrence, remote tumor occurrence, and age and gender.||-0.1308|-1.6894|0.0221
72496915|NCT00132041|144523319|OTHER||Mean Difference (Final Values)|-0.458|STANDARD_ERROR_OF_MEAN|0.2496||0.06|TWO_SIDED|||||assuming unequal variance (Satterthwaite p)|t-test, 2 sided||Difference represents the size of tumors that do no recur minus those that do.|the mean tumor size in the two groups, recurred and non recurred tumors, will be compared using a t-test assuming H0: recur=non-recurr||||0.06
72496916|NCT00132041|144523321|OTHER||Sensitivity|0.083|||||TWO_SIDED|95.0|0.0|0.38|||||Twelve tumors were detected in the liver specimens, but only one of those was identified by the CT central readers|||0.38|0.00|
72496917|NCT00132041|144523321|OTHER||Specificity|0.75|||||TWO_SIDED|95.0|0.194|0.994|||||The central CT readers correctly identified three out of the four patients without pathologic evidence of tumor|Specificity||0.994|0.194|
72496918|NCT00132041|144523323|OTHER|McNemar's Test to compare success rates after assuming transplants as successes versus after assuming transplants as failures.||||||0.0001|||||||McNemar|||||||0.0001
72496919|NCT01307033|144523364|SUPERIORITY_OR_OTHER_LEGACY||Difference in least squares means|0.2|||||TWO_SIDED|95.0|-1.7|2.2|||Constained logitudinal data analysis|Model included treatment, time and the interaction of time by treatment with a restriction of the same baseline mean across treatment groups||||2.2|-1.7|
72496920|NCT01307033|144523365|SUPERIORITY_OR_OTHER_LEGACY||Difference in least squares means|-2.3|||||TWO_SIDED|95.0|-5.0|0.5|||Constained longitudinal data analysis|Model included treatment, time and the interaction of time by treatment with a restriction of the same baseline mean across treatment groups||||0.5|-5.0|
72504697|NCT01709799|144540122|SUPERIORITY_OR_OTHER|||||||0.63|TWO_SIDED|||||P-value is not adjusted for multiple comparisons, and p \< .05 is the a priori threshold for statistical significance|Mixed Models Analysis|degrees of freedom are (2,115.573)||Occasion main effect. Null hypothesis is no improvement (Occasion main effect has p-value \> .05)||||0.630
72504698|NCT01709799|144540122|SUPERIORITY_OR_OTHER|||||||0.498|TWO_SIDED|||||P-value is not adjusted for multiple comparisons, and p \< .05 is the a priori threshold for statistical significance|Mixed Models Analysis|degrees of freedom are (4,115.593)||Occasion by arm interaction. Null hypothesis of no group differences in improvement (Interaction has p-value \> .05)||||0.498
72504699|NCT00435539|144540123|SUPERIORITY_OR_OTHER|||||||0.4783|||||||Fisher Exact|||||||0.4783
72560068|NCT02614196|144650655|SUPERIORITY||Odds Ratio (OR)|2.42|||||TWO_SIDED|95.0|1.84|3.17||||||Reduction from Baseline ≥75%||3.17|1.84|
72560069|NCT02614196|144650655|SUPERIORITY||Odds Ratio (OR)|2.16|||||TWO_SIDED|95.0|1.5|3.12||||||Reduction from Baseline ≥100%||3.12|1.50|
72560070|NCT02614196|144650655|SUPERIORITY||Odds Ratio (OR)|2.67|||||TWO_SIDED|95.0|1.87|3.81||||||Reduction from Baseline ≥100%||3.81|1.87|
72560071|NCT02614196|144650656|SUPERIORITY||LSMean Difference|8.82|STANDARD_ERROR_OF_MEAN|1.27|<|0.001|TWO_SIDED|95.0|6.33|11.31|||Mixed Models Analysis|||||11.31|6.33|<.001
72560072|NCT02614196|144650656|SUPERIORITY||LSMean Difference|7.39|STANDARD_ERROR_OF_MEAN|1.28|<|0.001|TWO_SIDED|95.0|4.88|9.9|||Mixed Models Analysis|||||9.90|4.88|<.001
72443433|NCT02721381|144400376|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||The effect of group assignment was examined using MLM, with a significant time X group interaction indicative of an effect of group assignment. Data from T1, T2, and T3 were both used in same analysis.||||<.001
72443434|NCT02721381|144400377|SUPERIORITY|||||||0.85|||||||Mixed Models Analysis|||The effect of group assignment was examined using MLM, with a significant time X group interaction indicative of an effect of group assignment. Data from T1, T2, and T3 were both used in same analysis.||||.85
72443435|NCT02721381|144400378|SUPERIORITY|||||||0.85|||||||Mixed Models Analysis|||The effect of group assignment was examined using MLM, with a significant time X group interaction indicative of an effect of group assignment. Data from T1, T2, and T3 were both used in same analysis.||||.85
72443436|NCT02721381|144400379|SUPERIORITY|||||||0.98|||||||ANCOVA|||||||.98
72443437|NCT02721381|144400380|SUPERIORITY|||||||0.69|||||||ANCOVA|||||||.69
72443438|NCT02721381|144400381|SUPERIORITY|||||||0.038|||||||Mixed Models Analysis|||The effect of group assignment was examined using MLM, with a significant time X group interaction indicative of an effect of group assignment. Data from T1, T2, and T3 were both used in same analysis.||||.038
72443439|NCT02721381|144400382|SUPERIORITY|||||||0.45|||||||Mixed Models Analysis|||The effect of group assignment was examined using MLM, with a significant time X group interaction indicative of an effect of group assignment. Data from T1, T2, and T3 were both used in same analysis.||||.45
72443440|NCT02721381|144400383|SUPERIORITY|||||||0.92|||||||ANCOVA|||ANCOVA controlling for T1 measure||||.92
72443441|NCT02721381|144400384|SUPERIORITY|||||||0.42|||||||ANCOVA|||ANCOVA controlling for T1 measure||||.42
72443442|NCT02721381|144400385|SUPERIORITY|||||||0.65|||||||ANCOVA|||ANCOVA controlling for T1 measure||||.65
72496921|NCT00947531|144523375|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.17|||<|0.0001|TWO_SIDED|95.0|-8.22|-4.13||P-value obtained from the F-test statistic of Cerebrolysin versus Placebo as part of ANCOVA (analysis of covariance). No adjustment for multiple comparisons was needed. The overall significance level alpha was fixed at alpha = 0.05 (two-sided).|ANCOVA|The study was designed to show significant differences in each of the two primary variables. No adjustment for multiple comparisons was needed.||The null-hypothesis stated no difference between the two treatment groups. A sample size of 103 evaluable patients per treatment group was estimated to allow for the detection of a significant group difference of 4.1 points in ADAS-cog+ weak 24 change score (standard deviation \[SD\] 9.0) in favor of Cerebrolysin with a power of 90% and a probability level of alpha-level 0.025 (one-sided).||-4.13|-8.22|< 0.0001
72443443|NCT02721381|144400386|SUPERIORITY|||||||0.001|||||||t-test, 2 sided|||Independent samples t-test||||.001
72496922|NCT01773421|144523405|EQUIVALENCE|Log-transformed pharmacokinetic parameters were fit using a mixed effects model with sequence, treatment, period and sequence as fixed effects and participant as a random effect. Geometric LS means and geometric LS mean ratio were back-transformed to obtain the treatment estimates.|Geometric Least Square (LS) Mean Ratio|1.06|||||TWO_SIDED|90.0|0.97|1.15||||||||1.15|0.97|
72504700|NCT00435539|144540123|SUPERIORITY_OR_OTHER|||||||0.0932|||||||Fisher Exact|||||||0.0932
72443444|NCT05687903|144400394|SUPERIORITY||Estimate of LS Mean Difference|13.65|STANDARD_ERROR_OF_MEAN|2.983|=|0.001|TWO_SIDED|95.0|7.74|19.57||The analysis used a linear MMRM with fixed effects for Baseline, age, prior use of narcolepsy medications, treatment, visit, and treatment-by-visit interaction as covariates. Reported p-value is adjusted for multiplicity.|MMRM|An unstructured variance-covariance structure was used.|LS in LS Mean Difference denotes least squares.|||19.57|7.74|=0.001
72443445|NCT05687903|144400394|SUPERIORITY||Estimate of LS Mean Difference|24.67|STANDARD_ERROR_OF_MEAN|2.921|<|0.001|TWO_SIDED|95.0|18.87|30.46||The analysis used a linear MMRM with fixed effects for Baseline, age, prior use of narcolepsy medications, treatment, visit, and treatment-by-visit interaction as covariates. Reported p-value is adjusted for multiplicity.|MMRM|An unstructured variance-covariance structure was used.||||30.46|18.87|<0.001
72443446|NCT05687903|144400394|SUPERIORITY||Estimate of LS Mean Difference|26.58|STANDARD_ERROR_OF_MEAN|2.91|<|0.001|TWO_SIDED|95.0|20.81|32.35||The analysis used a linear MMRM with fixed effects for Baseline, age, prior use of narcolepsy medications, treatment, visit, and treatment-by-visit interaction as covariates. Reported p-value is adjusted for multiplicity.|MMRM|An unstructured variance-covariance structure was used.||||32.35|20.81|<0.001
72443447|NCT05687903|144400394|SUPERIORITY||Estimate of LS Mean Difference|16.13|STANDARD_ERROR_OF_MEAN|2.842|<|0.001|TWO_SIDED|95.0|10.49|21.76||The analysis used a linear MMRM with fixed effects for Baseline, age, prior use of narcolepsy medications, treatment, visit, and treatment-by-visit interaction as covariates. Reported p-value is adjusted for multiplicity.|MMRM|An unstructured variance-covariance structure was used.||||21.76|10.49|<0.001
72443448|NCT05687903|144400395|SUPERIORITY||Estimate of LS Mean Difference|-6.42|STANDARD_ERROR_OF_MEAN|1.564|=|0.004|TWO_SIDED|95.0|-9.53|-3.32||The analysis used a linear MMRM with fixed effects for Baseline, age, prior use of narcolepsy medications, treatment, visit, and treatment-by-visit interaction as covariates. Reported p-value is adjusted for multiplicity.|MMRM|An unstructured variance-covariance structure was used.||||-3.32|-9.53|=0.004
72443449|NCT05687903|144400395|SUPERIORITY||Estimate of LS Mean Difference|-11.3|STANDARD_ERROR_OF_MEAN|1.581|<|0.001|TWO_SIDED|95.0|-14.44|-8.16||The analysis used a linear MMRM with fixed effects for Baseline, age, prior use of narcolepsy medications, treatment, visit, and treatment-by-visit interaction as covariates. Reported p-value is adjusted for multiplicity.|MMRM|An unstructured variance-covariance structure was used.||||-8.16|-14.44|<0.001
72443450|NCT05687903|144400395|SUPERIORITY||Estimate of LS Mean Difference|-10.31|STANDARD_ERROR_OF_MEAN|1.53|<|0.001|TWO_SIDED|95.0|-13.35|-7.27||The analysis used a linear MMRM with fixed effects for Baseline, age, prior use of narcolepsy medications, treatment, visit, and treatment-by-visit interaction as covariates. Reported p-value is adjusted for multiplicity.|MMRM|An unstructured variance-covariance structure was used.||||-7.27|-13.35|<0.001
72443451|NCT05687903|144400395|SUPERIORITY||Estimate of LS Mean Difference|-8.79|STANDARD_ERROR_OF_MEAN|1.535|<|0.001|TWO_SIDED|95.0|-11.84|-5.75||The analysis used a linear MMRM with fixed effects for Baseline, age, prior use of narcolepsy medications, treatment, visit, and treatment-by-visit interaction as covariates. Reported p-value is adjusted for multiplicity.|MMRM|An unstructured variance-covariance structure was used.||||-5.75|-11.84|<0.001
72496923|NCT01773421|144523406|EQUIVALENCE|Log-transformed pharmacokinetic parameters were fit using a mixed effects model with sequence, treatment, period and sequence as fixed effects and participant as a random effect. Geometric LS means and geometric LS mean ratio were back-transformed to obtain the treatment estimates.|Geometric LS Mean Ratio|1.11|||||TWO_SIDED|90.0|1.02|1.2||||||||1.2|1.02|
72496924|NCT01773421|144523407|EQUIVALENCE|Log-transformed pharmacokinetic parameters were fit using a mixed effects model with sequence, treatment, period and sequence as fixed effects and participant as a random effect. Geometric LS means and geometric LS mean ratio were back-transformed to obtain the treatment estimates.|Geometric LS Mean Ratio|1.13|||||TWO_SIDED|90.0|1.0|1.27||||||||1.27|1|
72496925|NCT02804763|144523430|SUPERIORITY||||||=|0.0727||||||The lowest p-value (z-statistic with the highest value) was used to establish proof of dose response.|MCP-Mod|||"Multiple contrast testing (MCP-mod methodology) was used to test for a statistically significant dose-response relationship between the primary endpoint (BICLA at Week 24) and dose, which would indicate a drug effect of DZP over Placebo.~The best fitting statistically significant model could be used to estimate the dose needed to achieve desired treatment effect."||||=0.0727
72496926|NCT02804763|144523431|SUPERIORITY||Odds Ratio (OR)|1.6|||=|0.2699|TWO_SIDED|95.0|0.7|3.8||Generalized linear models with factors for treatment and corticosteroid strata were fit using a logit link function for the odds ratios and p-values.|Chi-squared|||Missing values were imputed using modified non-responder imputation (mNRI) dataset: at most 1 missing BICLA (mNRI) component (scale) may have been carried forward from the immediately preceding visit, and missing data in the individual items within scales may have been carried forward from the immediately preceding visit. If there was still missing data after this limited imputation, the study participant was counted as a non-responder on the BICLA (mNRI) for that visit.||3.8|0.7|=0.2699
72496927|NCT02804763|144523431|SUPERIORITY||Odds Ratio (OR)|2.0|||=|0.1036|TWO_SIDED|95.0|0.9|4.8||Generalized linear models with factors for treatment and corticosteroid strata were fit using a logit link function for the odds ratios and p-values.|Chi-squared|||Missing values were imputed using modified non-responder imputation (mNRI) dataset: at most 1 missing BICLA (mNRI) component (scale) may have been carried forward from the immediately preceding visit, and missing data in the individual items within scales may have been carried forward from the immediately preceding visit. If there was still missing data after this limited imputation, the study participant was counted as a non-responder on the BICLA (mNRI) for that visit.||4.8|0.9|=0.1036
72496928|NCT02804763|144523431|SUPERIORITY||Odds Ratio (OR)|1.9|||=|0.1518|TWO_SIDED|95.0|0.8|4.3||Generalized linear models with factors for treatment and corticosteroid strata were fit using a logit link function for the odds ratios and p-values.|Chi-squared|||Missing values were imputed using modified non-responder imputation (mNRI) dataset: at most 1 missing BICLA (mNRI) component (scale) may have been carried forward from the immediately preceding visit, and missing data in the individual items within scales may have been carried forward from the immediately preceding visit. If there was still missing data after this limited imputation, the study participant was counted as a non-responder on the BICLA (mNRI) for that visit.||4.3|0.8|=0.1518
72504701|NCT00435539|144540123|SUPERIORITY_OR_OTHER|||||||0.0721|||||||Fisher Exact|||||||0.0721
72388730|NCT02100514|144285718|SUPERIORITY_OR_OTHER||LS mean difference compared to placebo|-0.3|STANDARD_ERROR_OF_MEAN|0.04||||95.0|-0.4|-0.2||||||Week 52: LS mean difference and associated 95% confidence interval CI were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-0.2|-0.4|
72388731|NCT02100514|144285719|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|53.9||||||95.0|32.08|90.59||||||Week 12: Odds ratio, associated 95% CI were derived from a logistic regression model with fixed effects for treatment group, baseline value, geographical region and triglyceride subgroup.||90.59|32.08|
72388732|NCT02100514|144285719|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|17.0||||||95.0|11.15|26.07||||||Week 24: Odds ratio, associated 95% CI were derived from a logistic regression model with fixed effects for treatment group, baseline value, geographical region and triglyceride subgroup.||26.07|11.15|
72388733|NCT02100514|144285719|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|9.1||||||95.0|6.18|13.48||||||Week 52: Odds ratio, associated 95% CI were derived from a logistic regression model with fixed effects for treatment group, baseline value, geographical region and triglyceride subgroup.||13.48|6.18|
72388734|NCT02100514|144285720|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|156.4||||||95.0|48.84|501.11||||||Week 12: Odds ratio, associated 95% CI were derived from a logistic regression model with fixed effects for treatment group, baseline value, geographical region and triglyceride subgroup.||501.11|48.84|
72388735|NCT02100514|144285720|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|110.8||||||95.0|39.77|308.46||||||Week 24: Odds ratio, associated 95% CI were derived from a logistic regression model with fixed effects for treatment group, baseline value, geographical region and triglyceride subgroup.||308.46|39.77|
72388736|NCT02100514|144285720|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|43.3||||||95.0|19.52|96.13||||||Week 52: Odds ratio, associated 95% CI were derived from a logistic regression model with fixed effects for treatment group, baseline value, geographical region and triglyceride subgroup.||96.13|19.52|
72388737|NCT02218320|144285732|OTHER|||||||1|||||||Wilcoxon (Mann-Whitney)|||||||1.0
72388738|NCT02096731|144285739|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.12|||||TWO_SIDED|95.0|0.92|1.37|||||"HR adjusted for 10 year age groups, sex, calendar year of cohort entry, the decile of propensity score, ipratropium use prior to cohort entry and time since entry into base cohort.~Ratio calculated as combination therapy divided by monotherapy."|||1.37|0.92|
72388739|NCT02096731|144285740|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.87|||||TWO_SIDED|95.0|0.69|1.1|||||"HR adjusted for 10 year age groups, sex, calendar year of cohort entry, the decile of propensity score, ipratropium use prior to cohort entry and time since entry into base cohort.~Ratio calculated as combination therapy divided by monotherapy."|||1.10|0.69|
72388740|NCT02096731|144285741|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.16|||||TWO_SIDED|95.0|1.03|1.3|||||"HR adjusted for 10 year age groups, sex, calendar year of cohort entry, the decile of propensity score, ipratropium use prior to cohort entry and time since entry into base cohort.~Ratio calculated as combination therapy divided by monotherapy."|||1.30|1.03|
72388741|NCT02096731|144285742|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.05|||||TWO_SIDED|95.0|0.81|1.36|||||"HR adjusted for 10 year age groups, sex, calendar year of cohort entry, the decile of propensity score, ipratropium use prior to cohort entry and time since entry into base cohort.~Ratio calculated as combination therapy divided by monotherapy."|||1.36|0.81|
72496929|NCT02804763|144523431|SUPERIORITY||Difference vs PBO|11.6|||||TWO_SIDED|95.0|-9.2|32.4||Crude difference in proportion responding and standard Wald asymptotic 95 % CI based on the normal approximation to the binomial distribution.|Chi-squared||Difference and 95 % Wald CI in proportion of responders for SOC + DZP dose 1 iv Q4W (FAS) versus SOC + Placebo iv Q4W (FAS).|Missing values were imputed using modified non-responder imputation (mNRI) dataset: at most 1 missing BICLA (mNRI) component (scale) may have been carried forward from the immediately preceding visit, and missing data in the individual items within scales may have been carried forward from the immediately preceding visit. If there was still missing data after this limited imputation, the study participant was counted as a non-responder on the BICLA (mNRI) for that visit.||32.4|-9.2|
72496930|NCT02804763|144523431|SUPERIORITY||Difference vs PBO|17.3|||||TWO_SIDED|95.0|-3.3|38.0||Crude difference in proportion responding and standard Wald asymptotic 95 % CI based on the normal approximation to the binomial distribution.|Chi-squared||Difference and 95 % Wald CI in proportion of responders for SOC + DZP dose 2 iv Q4W (FAS) versus SOC + Placebo iv Q4W (FAS).|Missing values were imputed using modified non-responder imputation (mNRI) dataset: at most 1 missing BICLA (mNRI) component (scale) may have been carried forward from the immediately preceding visit, and missing data in the individual items within scales may have been carried forward from the immediately preceding visit. If there was still missing data after this limited imputation, the study participant was counted as a non-responder on the BICLA (mNRI) for that visit.||38.0|-3.3|
72496931|NCT02804763|144523431|SUPERIORITY||Difference vs PBO|15.0|||||TWO_SIDED|95.0|-5.5|35.4||Crude difference in proportion responding and standard Wald asymptotic 95 % CI based on the normal approximation to the binomial distribution.|Chi-squared||Difference and 95 % Wald CI in proportion of responders for SOC + DZP dose 3 iv Q4W (FAS) versus SOC + Placebo iv Q4W (FAS).|Missing values were imputed using modified non-responder imputation (mNRI) dataset: at most 1 missing BICLA (mNRI) component (scale) may have been carried forward from the immediately preceding visit, and missing data in the individual items within scales may have been carried forward from the immediately preceding visit. If there was still missing data after this limited imputation, the study participant was counted as a non-responder on the BICLA (mNRI) for that visit.||35.4|-5.5|
72496932|NCT02804763|144523431|SUPERIORITY||LS Mean Difference vs PBO|11.9|||||TWO_SIDED|95.0|-8.7|32.5||Generalized linear models with factors for treatment and corticosteroid strata were fit using an identity link function for the LS mean differences.|Chi-squared|||Missing values were imputed using modified non-responder imputation (mNRI) dataset: at most 1 missing BICLA (mNRI) component (scale) may have been carried forward from the immediately preceding visit, and missing data in the individual items within scales may have been carried forward from the immediately preceding visit. If there was still missing data after this limited imputation, the study participant was counted as a non-responder on the BICLA (mNRI) for that visit.||32.5|-8.7|
72496933|NCT02804763|144523431|SUPERIORITY||LS Mean Difference vs PBO|17.6|||||TWO_SIDED|95.0|-3.2|38.3||Generalized linear models with factors for treatment and corticosteroid strata were fit using an identity link function for the LS mean differences.|Chi-squared|||Missing values were imputed using modified non-responder imputation (mNRI) dataset: at most 1 missing BICLA (mNRI) component (scale) may have been carried forward from the immediately preceding visit, and missing data in the individual items within scales may have been carried forward from the immediately preceding visit. If there was still missing data after this limited imputation, the study participant was counted as a non-responder on the BICLA (mNRI) for that visit.||38.3|-3.2|
72496934|NCT02804763|144523431|SUPERIORITY||LS Mean Difference vs PBO|15.2|||||TWO_SIDED|95.0|-5.2|35.6||Generalized linear models with factors for treatment and corticosteroid strata were fit using an identity link function for the LS mean differences.|Chi-squared|||Missing values were imputed using modified non-responder imputation (mNRI) dataset: at most 1 missing BICLA (mNRI) component (scale) may have been carried forward from the immediately preceding visit, and missing data in the individual items within scales may have been carried forward from the immediately preceding visit. If there was still missing data after this limited imputation, the study participant was counted as a non-responder on the BICLA (mNRI) for that visit.||35.6|-5.2|
72560073|NCT02614196|144650657|SUPERIORITY||LSMean Difference|-1.82|STANDARD_ERROR_OF_MEAN|0.24|<|0.001|TWO_SIDED|95.0|-2.29|-1.36|||Mixed Models Analysis|||||-1.36|-2.29|<.001
72560074|NCT02614196|144650657|SUPERIORITY||LSMean Difference|-1.78|STANDARD_ERROR_OF_MEAN|0.24|<|0.001|TWO_SIDED|95.0|-2.25|-1.31|||Mixed Models Analysis|||||-1.31|-2.25|<.001
72560075|NCT02614196|144650658|SUPERIORITY||LSMean Difference|-0.29|STANDARD_ERROR_OF_MEAN|0.09||0.002|TWO_SIDED|95.0|-0.47|-0.11|||Mixed Models Analysis|||||-0.11|-0.47|.002
72496935|NCT04656990|144523489|SUPERIORITY||Slope|17.1|||<|0.0001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.0001
72496936|NCT04656990|144523492|SUPERIORITY||Slope|3.4|||=|0.04|TWO_SIDED||||||Mixed Models Analysis|||||||=0.04
72560076|NCT02614196|144650658|SUPERIORITY||LSMean Difference|-0.23|STANDARD_ERROR_OF_MEAN|0.09||0.012|TWO_SIDED|95.0|-0.41|-0.05|||Mixed Models Analysis|||||-0.05|-0.41|.012
72496937|NCT03657459|144523517|SUPERIORITY|||||||0.0096|||||||Chi-squared|Pearsons Chi Square||||||0.0096
72560077|NCT02614196|144650659|SUPERIORITY||LSMean Difference|-15.19|STANDARD_ERROR_OF_MEAN|2.59|<|0.001|TWO_SIDED|95.0|-20.27|-10.11|||Mixed Models Analysis|||||-10.11|-20.27|<.001
72560078|NCT02614196|144650659|SUPERIORITY||LSMean Difference|-13.56|STANDARD_ERROR_OF_MEAN|2.6|<|0.001|TWO_SIDED|95.0|-18.67|-8.44|||Mixed Models Analysis|||||-8.44|-18.67|<.001
72560079|NCT02614196|144650660|SUPERIORITY||LSMean Difference|-9.15|STANDARD_ERROR_OF_MEAN|1.76|<|0.001|TWO_SIDED|95.0|-12.61|-5.69|||Mixed Models Analysis|||||-5.69|-12.61|<.001
72560080|NCT02614196|144650660|SUPERIORITY||LSMean Difference|-8.22|STANDARD_ERROR_OF_MEAN|1.78|<|0.001|TWO_SIDED|95.0|-11.71|-4.72|||Mixed Models Analysis|||||-4.72|-11.71|<.001
72560081|NCT02614196|144650661|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||TE ADA Positive.||||<.001
72560082|NCT02614196|144650661|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||TE ADA Positive||||<.001
72560083|NCT02627001|144650674|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon Signed Ranks|||||||<0.001
72560084|NCT00660387|144650675|SUPERIORITY_OR_OTHER||Treatment Difference (LS Mean)|-1.91|STANDARD_ERROR_OF_MEAN|0.57||0.0015|TWO_SIDED|95.0|-3.05|-0.76||Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding baseline and the natural logarithm of the mean daily dose of rescue medication on valid symptom diary days as covariates.|ANCOVA|||||-0.76|-3.05|0.0015
72388742|NCT02096731|144285743|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.35|||||TWO_SIDED|95.0|1.23|1.5|||||"HR adjusted for 10 year age groups, sex, calendar year of cohort entry, the decile of propensity score, ipratropium use prior to cohort entry and time since entry into base cohort.~Ratio calculated as combination therapy divided by monotherapy."|||1.50|1.23|
72388743|NCT01496248|144285768|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||ANOVA|||||||<0.05
72388744|NCT01496248|144285769|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||ANOVA|||||||<0.05
72388745|NCT01496248|144285770|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||ANOVA|||||||<0.05
72388746|NCT01496248|144285771|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||ANOVA|||||||<0.05
72388747|NCT01496248|144285772|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||ANOVA|||||||<0.05
72388748|NCT01496248|144285773|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||ANOVA|||||||<0.05
72388749|NCT01496248|144285774|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||ANOVA|||||||<0.05
72388750|NCT01496248|144285775|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||ANOVA|||||||<0.05
72388751|NCT02983825|144285805|SUPERIORITY|Wilcoxon signed-rank test for nonparametric matched-pairs||||||0.02|||||||Sign test|||"Within subject repeat analysis; V/Q mismatch (measured as degree of right shift in kPa) baseline vs best CPAP"||||0.02
72388752|NCT01702805|144285807|SUPERIORITY||Risk Ratio (RR)|1.0||||0.93|TWO_SIDED|95.0|0.92|1.1|||Robust Poisson Regression|The relative risk was adjusted for birth-weight and center stratum.||Null hypothesis: A higher hemoglobin threshold for red-cell transfusions, as compared with a lower threshold, will not reduce nor increase the incidence of death or neurodevelopmental impairment in infants at 22 to 26 months of age corrected for prematurity.||1.10|0.92|0.93
72388753|NCT04457336|144285844|OTHER|Assessment of dose response for change from baseline in log 17-OHP after 12 weeks on double-blind, placebo-controlled treatment (Week 18). Results were obtained by using a repeated measures random coefficient mixed-effects model and are reported as the -2loglikelihood results for both the full (including interaction terms) and reduced (excluding interaction terms) models.||||||0.8051||||||Dose response p-value|Mixed Models Analysis|The result for the -2loglikelihood full model was -580.2550766 log(ng/dL) and -583.2846546 log(ng/dL) for the reduced model.||||||0.8051
72388754|NCT02284516|144285846|SUPERIORITY_OR_OTHER_LEGACY||Treatment Effect|7.16|STANDARD_ERROR_OF_MEAN|2.096|=|0.0007|TWO_SIDED|95.0|3.04|11.28||The primary analysis was performed using a stratified 2-sample t-test (that is, analysis of variance \[ANOVA\]).|ANOVA|||||11.28|3.04|=0.0007
72388755|NCT02284516|144285847|SUPERIORITY_OR_OTHER_LEGACY||Treatment Effect|7.85|STANDARD_ERROR_OF_MEAN|1.792|<|0.0001|TWO_SIDED|95.0|4.33|11.37||The primary analysis was performed using a stratified 2-sample t-test (that is, analysis of variance \[ANOVA\]).|ANOVA|||Baseline and Day 14||11.37|4.33|<0.0001
72388756|NCT02284516|144285847|SUPERIORITY_OR_OTHER_LEGACY||Treatment Effect|9.32|STANDARD_ERROR_OF_MEAN|1.976|<|0.0001|TWO_SIDED|95.0|5.44|13.2||The primary analysis was performed using a stratified 2-sample t-test (that is, analysis of variance \[ANOVA\]).|ANOVA|||Baseline and Day 42||13.20|5.44|<0.0001
72388757|NCT01350492|144285907|SUPERIORITY||Wilks' Lambda|0.939||||0.68|TWO_SIDED|||||The threshold for statistical significance was p = 0.05.|Multivariate regression|A Generalized Linear Model was employed with repeated measurements of pain ratings as the multivariate dependent variables and group as covariate.||General multivariate regression models were used to estimate the time averaged difference in pain ratings and other symptom scores (continuous measurements) between the treatment and the control group. In order to achieve 90% power, at alpha equal to .05, with an effect size of .6 (minimum effect size of clinical importance) and with a correlation of .6 between measurements from each individual, we estimated the necessary sample size at 34 subjects per group.||||0.680
72388758|NCT01350492|144285908|SUPERIORITY||Wilks' Lambda|0.96||||0.854|TWO_SIDED|||||The threshold for statistical significance was p = 0.05.|Mulitvariate regression|A Generalized Linear Model was employed with repeated measurements of pain ratings as the multivariate dependent variables and group as covariate.||General multivariate regression models were used to estimate the time averaged difference in pain ratings and other symptom scores (continuous measurements) between the treatment and the control group. In order to achieve 90% power, at alpha equal to .05, with an effect size of .6 (minimum effect size of clinical importance) and with a correlation of .6 between measurements from each individual, we estimated the necessary sample size at 34 subjects per group.||||0.854
72388759|NCT01350492|144285909|SUPERIORITY|||||||0.0002||||||The threshold for statistical significance was p = 0.05.|Multivariate regression|A Generalized Linear Model was employed with repeated measurements of pain ratings as the multivariate dependent variables and group as covariate.||General multivariate regression models were used to estimate the time averaged difference in pain ratings and other symptom scores (continuous measurements) between the treatment and the control group. In order to achieve 90% power, at alpha equal to .05, with an effect size of .6 (minimum effect size of clinical importance) and with a correlation of .6 between measurements from each individual, we estimated the necessary sample size at 34 subjects per group.||||0.0002
72388760|NCT01350492|144285910|SUPERIORITY||Wilks' Lambda|0.857||||0.41|TWO_SIDED|||||The threshold for statistical significance was p = 0.05.|Multivariate regression|A Generalized Linear Model was employed with repeated measurements of pain ratings as the multivariate dependent variables and group as covariate.||General multivariate regression models were used to estimate the time averaged difference in pain ratings and other symptom scores (continuous measurements) between the treatment and the control group. In order to achieve 90% power, at alpha equal to .05, with an effect size of .6 (minimum effect size of clinical importance) and with a correlation of .6 between measurements from each individual, we estimated the necessary sample size at 34 subjects per group.||||0.41
72443452|NCT05687903|144400396|SUPERIORITY||IRR|0.48|||=|0.25|TWO_SIDED|95.0|0.25|0.93||GEE model featuring a negative binomial distribution was used for analysis where incidence rate was exponentiated LS mean \& incidence rate ratio (IRR) was exponentiated LS mean difference from placebo. Reported p-value is adjusted for multiplicity.|GEE|||The GEE model was used for analysis with fixed effects for visit, treatment, treatment-by-visit interaction, Baseline WCR, age, and prior use of narcolepsy medications.||0.93|0.25|=0.250
72443453|NCT05687903|144400396|SUPERIORITY||IRR|0.36|||=|0.034|TWO_SIDED|95.0|0.16|0.79||The GEE model featuring a negative binomial distribution was used for analysis where the incidence rate was the exponentiated LS mean and the IRR was the exponentiated LS mean difference from placebo. Reported p-value is adjusted for multiplicity.|GEE|||The GEE model was used for analysis with fixed effects for visit, treatment, treatment-by-visit interaction, Baseline WCR, age, and prior use of narcolepsy medications.||0.79|0.16|=0.034
72622388|NCT00855166|144774680|SUPERIORITY_OR_OTHER||Risk Difference (RD)|26.3|STANDARD_ERROR_OF_MEAN|5.309|<|0.0001|TWO_SIDED|95.0|15.9|36.7||Significant at alpha=0.05 (2-sided). Results of key secondary endpoints are interpreted using Hochberg's method|Regression, Logistic|Based on methodology of Zhang, Tsiatis \& Davidian and Davidian, Tsiatis, Zhang \& Lu, with adjustment for baseline value and stratum (gender).||H0: proportion(treat) minus proportion(placebo) = 0 versus the alternative HA: proportion(treat) minus proportion(placebo) =/= 0||36.7|15.9|<0.0001
72388761|NCT01350492|144285911|SUPERIORITY||Wilks' Lambda|0.828||||0.16|TWO_SIDED|||||The threshold for statistical significance was p = 0.05.|Multivariate regression|A Generalized Linear Model was employed with repeated measurements of pain ratings as the multivariate dependent variables and group as covariate.||General multivariate regression models were used to estimate the time averaged difference in pain ratings and other symptom scores (continuous measurements) between the treatment and the control group. In order to achieve 90% power, at alpha equal to .05, with an effect size of .6 (minimum effect size of clinical importance) and with a correlation of .6 between measurements from each individual, we estimated the necessary sample size at 34 subjects per group.||||0.16
72388762|NCT01350492|144285912|SUPERIORITY||Wilks' Lambda|0.919||||0.66|TWO_SIDED|||||The threshold for statistical significance was p = 0.05.|Multivariate regression|A Generalized Linear Model was employed with repeated measurements of pain ratings as the multivariate dependent variables and group as covariate.||General multivariate regression models were used to estimate the time averaged difference in pain ratings and other symptom scores (continuous measurements) between the treatment and the control group. In order to achieve 90% power, at alpha equal to .05, with an effect size of .6 (minimum effect size of clinical importance) and with a correlation of .6 between measurements from each individual, we estimated the necessary sample size at 34 subjects per group.||||0.66
72388763|NCT04203498|144285913|SUPERIORITY||Difference in least squares means|-0.73|STANDARD_ERROR_OF_MEAN|0.914|=|0.4263|TWO_SIDED|95.0|-2.54|1.08|||Linear mixed model repeated measures|||Week 9 to 12 (primary outcome statistics)||1.08|-2.54|=0.4263
72388764|NCT00939640|144285928|SUPERIORITY_OR_OTHER_LEGACY|||||||0.17|TWO_SIDED||||||Wilcoxon matched-pairs|||||||.17
72388765|NCT00939640|144285929|SUPERIORITY_OR_OTHER_LEGACY|||||||0.02||95.0|||||Wilcoxon matched-pairs tests|||||||.02
72388766|NCT00939640|144285934|SUPERIORITY|||||||0.006|||||||t-test, 2 sided|||||||.006
72388767|NCT00939640|144285935|SUPERIORITY|||||||0.02|||||||t-test, 2 sided|||||||.02
72388768|NCT01235689|144285941|SUPERIORITY|||||||0.01|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test stratified by Screening smoking status (yes or no) and weight (\< 70 kg or ≥ 70 kg).||||||0.010
72388769|NCT01235689|144285942|SUPERIORITY|||||||0.014|||||||Cochran-Mantel-Haenszel|CMH test stratified by screening smoking status (yes or no) and weight (\< 70 kg, ≥ 70 kg).||||||0.014
72388770|NCT01235689|144285943|SUPERIORITY|||||||0.006|||||||Cochran-Mantel-Haenszel|CMH test stratified by screening smoking status (yes or no) and weight (\< 70 kg, ≥ 70 kg).||||||0.006
72388771|NCT01235689|144285944|SUPERIORITY|||||||0.01|||||||Cochran-Mantel-Haenszel|CMH test stratified by screening smoking status (yes or no) and weight (\< 70 kg, ≥ 70 kg).||||||0.010
72388772|NCT01235689|144285945|SUPERIORITY|||||||0.299|||||||Cochran-Mantel-Haenszel|CMH test stratified by screening smoking status (yes or no) and weight (\< 70 kg, ≥ 70 kg).||||||0.299
72388773|NCT01235689|144285946|SUPERIORITY|||||||0.728|||||||Cochran-Mantel-Haenszel|CMH test stratified by screening smoking status (yes or no) and weight (\< 70 kg, ≥ 70 kg).||||||0.728
72388774|NCT01235689|144285947|SUPERIORITY|||||||0.067|||||||Cochran-Mantel-Haenszel|CMH test stratified by screening smoking status (yes or no) and weight (\< 70 kg, ≥ 70 kg).||||||0.067
72388775|NCT01235689|144285948|SUPERIORITY||LS Mean Difference|-1.4||||0.116|TWO_SIDED|95.0|-3.2|0.4|||ANCOVA|Model included factors for treatment group, screening smoking status (yes or no), and weight (\< 70 kg, ≥ 70 kg), and Baseline values as covariate.||||0.4|-3.2|0.116
72388776|NCT01235689|144285950|SUPERIORITY||Cox Proportional Hazard|0.442||||0.012|TWO_SIDED|95.0|0.2|0.8|||Regression, Cox|||||0.8|0.2|0.012
72388777|NCT01235689|144285951|SUPERIORITY||Cox Proportional Hazard|1.45||||0.008|TWO_SIDED|95.0|1.1|1.9|||Regression, Cox|||||1.9|1.1|0.008
72388778|NCT01235689|144285952|SUPERIORITY||Cox Proportional Hazard|1.337||||0.052|TWO_SIDED|95.0|1.0|1.8|||Regression, Cox|||||1.8|1.0|0.052
72388779|NCT01235689|144285955|SUPERIORITY||Cox Proportional Hazard|0.823||||0.501|TWO_SIDED|95.0|0.5|1.5|||Regression, Cox|||||1.5|0.5|0.501
72388780|NCT01235689|144285956|SUPERIORITY||Cox Proportional Hazard|0.785||||0.459|TWO_SIDED|95.0|0.4|1.5|||Regression, Cox|||||1.5|0.4|0.459
72388781|NCT01235689|144285963|SUPERIORITY||Cox Proportional Hazard|0.423||||0.212|TWO_SIDED|95.0|0.1|1.6|||Regression, Cox|||||1.6|0.1|0.212
72388782|NCT00005044|144286006|SUPERIORITY||Hazard Ratio (HR)|0.81||||0.45|TWO_SIDED|95.0|0.48|1.39|||Log Rank||Reference level = TAS x 8 weeks|Assuming 40% of deaths in the 8-wk arm from prostate cancer (PC) and that 8-yr DSS would be 79%, 270 PC deaths were required to detect a 33% hazard reduction in the 28-wk arm with 90% power using the log-rank test with a 2-sided significance level of 0.05. Under assumed failure rates, 1,540 patients accrued over 4 years and observed for an additional 6 years were expected to provide the requisite events. This sample accounted for a 10% ineligible/lack-of-data rate and 3 interim analyses.||1.39|0.48|0.45
72388783|NCT00005044|144286007|SUPERIORITY||Hazard Ratio (HR)|0.95||||0.62|TWO_SIDED|95.0|0.79|1.15|||Log Rank|2-sided significance level of 0.05|Reference level = TAS x 8 weeks|With 1540 patients accrued over 4 years and observed for an additional 6 years, determined for the primary endpoint, there would be 90% power to detect a 22% reduction in the hazard of all cause deaths in the 28-week arm, with 2-sided significance level of 0.05. This sample accounted for a 10% ineligible/lack-of-data rate.||1.15|0.79|0.62
72504702|NCT00435539|144540124|SUPERIORITY_OR_OTHER|||||||0.4762|||||||Fisher Exact|||||||0.4762
72504703|NCT00435539|144540124|SUPERIORITY_OR_OTHER|||||||0.4762|||||||Fisher Exact|||||||0.4762
72504704|NCT00435539|144540124|SUPERIORITY_OR_OTHER|||||||0.5343|||||||Fisher Exact|||||||0.5343
72504705|NCT00417612|144540133|SUPERIORITY_OR_OTHER_LEGACY|||||||0.007|TWO_SIDED||||||ANOVA|||||||0.007
72504706|NCT00685178|144540144|SUPERIORITY||F-value for main effect of Condition|2.21||||0.531|TWO_SIDED|||||Using the proportion of negative urine samples obtained, the four groups were compared to determine whether there are any group differences in cocaine abstinence (as measured by negative urine samples).|Chi-squared||F-value for main effect of Drug Condition|||||0.531
72443454|NCT05687903|144400396|SUPERIORITY||IRR|0.28|||=|0.003|TWO_SIDED|95.0|0.13|0.6||The GEE model featuring a negative binomial distribution was used for analysis where the incidence rate was the exponentiated LS mean and the IRR was the exponentiated LS mean difference from placebo. Reported p-value is adjusted for multiplicity.|GEE|||The GEE model was used for analysis with fixed effects for visit, treatment, treatment-by-visit interaction, Baseline WCR, age, and prior use of narcolepsy medications.||0.60|0.13|=0.003
72443455|NCT05687903|144400396|SUPERIORITY||IRR|0.67|||=|0.25|TWO_SIDED|95.0|0.35|1.29||The GEE model featuring a negative binomial distribution was used for analysis where the incidence rate was the exponentiated LS mean and the IRR was the exponentiated LS mean difference from placebo. Reported p-value is adjusted for multiplicity.|GEE|||The GEE model was used for analysis with fixed effects for visit, treatment, treatment-by-visit interaction, Baseline WCR, age, and prior use of narcolepsy medications.||1.29|0.35|=0.250
72443456|NCT04869982|144400453|OTHER|VE was defined as 1 minus the relative risk (RR). RR was defined as the ratio of the incidence rates of the RZV Group over the Placebo Group. The VE of RZV against HZ was to be demonstrated if the lower limit (LL) of the two-sided 95% CI of VE was above 25%.|VE (1-RR)|100.0|||<|0.0001|TWO_SIDED|95.0|89.82|100.0||All p-values reported were related to the null hypothesis test VE = 0.|Poisson|The CI for VE is derived from the exact CI from RR.||To demonstrate the vaccine efficacy (VE) of RZV against HZ, the analysis considered the exact inference on the relative risk adjusted for age strata conditionally to the total number of confirmed HZ cases observed and time at risk. This method computed an exact confidence interval (CI) around the rate ratio (ratio of the event rates in the RZV Group versus Placebo Group) and accounted for the sum of the time at risk of the participants within each group.||100|89.82|<0.0001
72443457|NCT02201108|144400470|SUPERIORITY||Hazard Ratio (HR)|0.657||||0.2949|TWO_SIDED|95.0|0.388|1.113||Threshold for significance was \< 0.05.|Stratified Log-Rank test|P-value derived from log-rank test with stratification of region and pubertal status.|Hazard ratio was estimated using a Cox proportional-hazards model with factors for treatment group, region, pubertal status, age, and number of relapses in the year prior to randomization as covariates and with robust variance estimation.|||1.113|0.388|0.2949
72443458|NCT02201108|144400472|OTHER||Relative risk ratio|0.511|||||TWO_SIDED|95.0|0.343|0.762||||||||0.762|0.343|
72443459|NCT02201108|144400473|OTHER||Relative risk ratio|0.57|||||TWO_SIDED|95.0|0.331|0.983||||||||0.983|0.331|
72496938|NCT03657459|144523518|SUPERIORITY|||||||0.9||||||no adjustment|Chi-squared|Pearson Chi-square||||||0.90
72619163|NCT03016403|144769031|SUPERIORITY||Mean Difference (Final Values)|-15.31||||0.0061|TWO_SIDED|95.0|-26.23|-4.39||Since there are three primary outcomes (depression, anxiety and coping scores) in the study, the significance level was set a priori at 0.0167 (alpha = 0.05/3).|Mixed Models Analysis|The pvalue corresponds to the hypothesis of an interaction between time and intervention arm.|The estimate represents the difference in expected means at the 6-month time point between the intervention and usual care arms.|Linear mixed models (LMM) have been used with time and the interaction between time and group as fixed effects. A structure of random effects that includes random intercepts for patients was used. The study was powered for testing the hypothesis of no group differences in change over the four time points. A significant group by time interaction was hypothesized.||-4.39|-26.23|0.0061
72443460|NCT02201108|144400476|OTHER||Relative risk ratio|0.498|||||TWO_SIDED|95.0|0.296|0.836||||||||0.836|0.296|
72443461|NCT02201108|144400490|OTHER||Hazard Ratio (HR)|0.693|||||TWO_SIDED|95.0|0.37|1.296|||||Hazard ratio estimated using a Cox proportional-hazards model using treatment group, region, pubertal status, age, and number of relapses in the year prior to randomisation as covariates and with robust variance estimation.|||1.296|0.37|
72443462|NCT03830177|144400492|SUPERIORITY||||||<|0.001|||||||t-test, 1 sided|||||||<0.001
72496939|NCT00282243|144523525|NON_INFERIORITY_OR_EQUIVALENCE|If the 90% CI for the ratio of the natural log-transformed pharmacokinetic parameters fell within an 80% to 125% range, then the exposure between the two formulations was considered to be equivalent.|Ratio of means|88.79|||||TWO_SIDED|90.0|85.42|92.29|||||Tacrolimus/tacrolimus MR ratio of natural log transformed means expressed as a percent.|The method of analysis of variance with repeated measures was used for the comparisons of AUC0-24. Exposure at steady state was used for tacrolimus (steady state was defined as days 14 and 42) and for tacrolimus MR (steady state was defined as days 28 and 56). The natural log (ln) was used to transform AUC0-24 prior to analysis and the results were transformed back to the original scale for the presentation of results.||92.29|85.42|
72443463|NCT03830177|144400493|SUPERIORITY||||||<|0.001|||||||t-test, 1 sided|||||||<0.001
72496940|NCT00282243|144523527|NON_INFERIORITY_OR_EQUIVALENCE|If the 90% CI for the ratio of the natural log-transformed pharmacokinetic parameters fell within an 80% to 125% range, then the exposure between the two formulations was considered to be equivalent.|Ratio of means|81.4|||||TWO_SIDED|90.0|77.88|85.08|||||Tacrolimus/tacrolimus MR ratio of natural log transformed means expressed as a percent.|The method of analysis of variance with repeated measures was used for the comparisons of Cmin. Exposure at steady state was used for tacrolimus (steady state was defined as days 14 and 42) and for tacrolimus MR (steady state was defined as days 28 and 56). The natural log (ln) was used to transform Cmin prior to analysis and the results were transformed back to the original scale for the presentation of results.||85.08|77.88|
72622389|NCT00855166|144774681|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.22|STANDARD_ERROR_OF_MEAN|0.5652||0.7013|TWO_SIDED|95.0|-0.89|1.34||Exploratory. Model including fixed categorical effects of treatment, week, treatment-by-week interaction, gender and rescue medication as well as continuous fixed covariates of baseline measurement and baseline measurement-by-week interaction.|Mixed Models Analysis|Percent change in BMD from baseline to week 102 evaluated via longitudinal repeated measures analysis using direct likelihood.|Natural logarithms of baseline and week 102 values were used.|H0: mean(treat) minus mean(placebo) = 0 versus the alternative HA: mean(treat) minus mean(placebo) =/= 0||1.34|-0.89|0.7013
72443464|NCT03830177|144400494|SUPERIORITY||||||<|0.001|||||||t-test, 1 sided|||||||<0.001
72443465|NCT03830177|144400495|SUPERIORITY||||||<|0.001|||||||t-test, 1 sided|||||||<0.001
72443466|NCT03830177|144400497|SUPERIORITY||||||<|0.001|||||||t-test, 1 sided|||||||<0.001
72443467|NCT04143061|144400499|NON_INFERIORITY|The overall non-inferiority was demonstrated if the lower limit of the 2-sided 95% confidence interval (CI) was \>-10% for all 4 serogroups. 95% CI of the difference was calculated from the Wilson Score method without continuity correction.|Difference in percentage of participants|6.55|||||TWO_SIDED|95.0|2.03|11.08||||||Statistical analysis for Serogroup A||11.08|2.03|
72443468|NCT04143061|144400499|NON_INFERIORITY|The overall non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI was \>-10% for all 4 serogroups. 95% CI of the difference was calculated from the Wilson Score method without continuity correction.|Difference in percentage of participants|21.67|||||TWO_SIDED|95.0|17.82|25.8||||||Statistical analysis for Serogroup C||25.80|17.82|
72443469|NCT04143061|144400499|NON_INFERIORITY|The overall non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI was \>-10% for all 4 serogroups. 95% CI of the difference was calculated from the Wilson Score method without continuity correction.|Difference in percentage of participants|11.08|||||TWO_SIDED|95.0|7.43|14.89||||||Statistical analysis for Serogroup Y||14.89|7.43|
72443470|NCT04143061|144400499|NON_INFERIORITY|The overall non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI was \>-10% for all 4 serogroups. 95% CI of the difference was calculated from the Wilson Score method without continuity correction.|Difference in percentage of participants|11.01|||||TWO_SIDED|95.0|7.86|14.47||||||Statistical analysis for Serogroup W||14.47|7.86|
72443471|NCT03289039|144400525|SUPERIORITY||Hazard Ratio (HR)|1.06||||0.98|TWO_SIDED|95.0|0.27|4.12|||Log Rank|||||4.12|0.27|0.98
72443472|NCT03289039|144400526|SUPERIORITY||Hazard Ratio (HR)|0.82||||0.89|TWO_SIDED|95.0|0.24|2.81|||Log Rank|||||2.81|0.24|0.89
72443473|NCT04732494|144400529|SUPERIORITY|The primary endpoint ORR was tested at a 2-sided alpha of 0.05.|Risk Difference (RD)|9.9||||0.2114|TWO_SIDED|95.0|-5.4|25.3|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel method stratified by the stratification factors (ECOG PS score \[0 vs 1\] and number of organs with metastases \[≤ 1 vs ≥ 2\]).|Mantel-Haenszel common risk difference stratified by the stratification factors (ECOG PS score \[0 vs 1\] and number of organs with metastases \[≤ 1 vs ≥ 2\]).|||25.3|-5.4|0.2114
72443474|NCT04732494|144400530|OTHER||Hazard Ratio (HR)|0.92|||||TWO_SIDED|95.0|0.58|1.45|||||Hazard ratio and 95% confidence intervals (CIs) were estimated using a Cox regression model stratified by the selected stratification factors (ECOG PS score \[0 vs 1\] and the number of organs with metastases \[≤ 1 vs ≥ 2\]).|||1.45|0.58|
72443475|NCT04732494|144400531|OTHER||Risk Difference (RD)|6.6|||||TWO_SIDED|95.0|-9.2|22.5|||||Mantel-Haenszel common risk difference stratified by the stratification factors (ECOG PS score \[0 vs 1\] and number of organs with metastases \[≤ 1 vs ≥ 2\]).|||22.5|-9.2|
72443476|NCT04732494|144400532|OTHER||Hazard Ratio (HR)|1.01|||||TWO_SIDED|95.0|0.64|1.59|||||Hazard ratio and 95% CIs were estimated using a Cox regression model stratified by the selected stratification factors (ECOG PS score \[0 vs 1\] and the number of organs with metastases \[≤ 1 vs ≥ 2\]).|||1.59|0.64|
72443477|NCT04732494|144400533|OTHER||Hazard Ratio (HR)|1.07|||||TWO_SIDED|95.0|0.71|1.61|||||Hazard ratio and 95% CIs were estimated using a Cox regression model stratified by the selected stratification factors (ECOG PS score \[0 vs 1\] and the number of organs with metastases \[≤ 1 vs ≥ 2\]).|||1.61|0.71|
72443478|NCT04732494|144400536|OTHER||Risk Difference (RD)|2.7|||||TWO_SIDED|95.0|-14.4|19.9|||||Mantel-Haenszel common risk difference stratified by the stratification factors (ECOG PS score \[0 vs 1\] and number of organs with metastases \[≤ 1 vs ≥ 2\]).|Analysis of Disease Control Rate Assessed by the Investigator||19.9|-14.4|
72443479|NCT04732494|144400536|OTHER||Risk Difference (RD)|5.0|||||TWO_SIDED|95.0|-11.7|21.8|||||Mantel-Haenszel common risk difference stratified by the stratification factors (ECOG PS score \[0 vs 1\] and number of organs with metastases \[≤ 1 vs ≥ 2\]).|Analysis of Disease Control Rate Assessed by the Independent Review Committee||21.8|-11.7|
72443480|NCT04732494|144400537|OTHER||Risk Difference (RD)|3.9|||||TWO_SIDED|95.0|-12.7|20.4|||||Mantel-Haenszel common risk difference stratified by the stratification factors (ECOG PS score \[0 vs 1\] and number of organs with metastases \[≤ 1 vs ≥ 2\]).|Analysis of Clinical Benefit Rate Assessed by the Investigator||20.4|-12.7|
72443481|NCT04732494|144400537|OTHER||Risk Difference (RD)|5.0|||||TWO_SIDED|95.0|-11.0|21.0|||||Mantel-Haenszel common risk difference stratified by the stratification factors (ECOG PS score \[0 vs 1\] and number of organs with metastases \[≤ 1 vs ≥ 2\]).|Analysis of Clinical Benefit Rate Assessed by the Independent Review Committee||21.0|-11.0|
72443482|NCT04732494|144400538|OTHER||Least Squares (LS) Mean Difference|1.8|||||TWO_SIDED|95.0|-8.4|11.9||||||Analysis of Change from Baseline in Global Health Status/QoL at Cycle 5. The mixed effect model analysis included the questionnaire score as dependent variable; baseline score, stratification factors, treatment arm, visit, and treatment arm by visit interaction as fixed effects; and visit as a repeated measure, with an unstructured covariance structure.||11.9|-8.4|
72443483|NCT04732494|144400538|OTHER||LS Mean Difference|3.1|||||TWO_SIDED|95.0|-5.0|11.2||||||Analysis of Change from Baseline in Global Health Status/QoL at Cycle 7. The mixed effect model analysis included the questionnaire score as dependent variable; baseline score, stratification factors, treatment arm, visit, and treatment arm by visit interaction as fixed effects; and visit as a repeated measure, with an unstructured covariance structure.||11.2|-5.0|
72443484|NCT04732494|144400538|SUPERIORITY||LS Mean Difference|-1.7|||||TWO_SIDED|95.0|-7.1|3.7||||||Analysis of Change from Baseline in Physical Functioning at Cycle 5. The mixed effect model analysis included the questionnaire score as dependent variable; baseline score, stratification factors, treatment arm, visit, and treatment arm by visit interaction as fixed effects; and visit as a repeated measure, with an unstructured covariance structure.||3.7|-7.1|
72443485|NCT04732494|144400538|OTHER||LS Mean Difference|-0.5|||||TWO_SIDED|95.0|-10.3|9.3||||||Analysis of Change from Baseline in Physical Functioning at Cycle 7. The mixed effect model analysis included the questionnaire score as dependent variable; baseline score, stratification factors, treatment arm, visit, and treatment arm by visit interaction as fixed effects; and visit as a repeated measure, with an unstructured covariance structure.||9.3|-10.3|
72443486|NCT04732494|144400539|OTHER||LS Mean Difference|-9.9|||||TWO_SIDED|95.0|-21.5|1.6||||||Analysis of Change from Baseline in Dysphagia at Cycle 5. The mixed effect model analysis included the questionnaire score as dependent variable; baseline score, stratification factors, treatment arm, visit, and treatment arm by visit interaction as fixed effects; and visit as a repeated measure, with an unstructured covariance structure.||1.6|-21.5|
72496941|NCT01070329|144523546|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.49|||<|0.001|TWO_SIDED|95.0|-0.75|-0.22||The P-value is for the main effect of treatment. The a priori threshold for statistical significance is 0.05.|Mixed Models Analysis|||||-0.22|-0.75|<0.001
72496942|NCT01070329|144523547|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.2|||<|0.001|TWO_SIDED|95.0|-5.77|-2.62||The a priori threshold for statistical significance is 0.05.|Mixed Models Analysis|||||-2.62|-5.77|<0.001
72560085|NCT00660387|144650676|SUPERIORITY_OR_OTHER||Treatment Difference (LS Mean)|1.86|STANDARD_ERROR_OF_MEAN|0.65||0.0059|TWO_SIDED|95.0|0.56|3.17|||ANCOVA|Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding baseline as a covariate.||Since the null hypothesis for the primary analysis was rejected in favor of the alternative hypothesis, hierarchical testing was performed for secondary variables on the Full Analysis data set at the 0.50 level using a gatekeeping procedure to preserve family-wise error rate.||3.17|0.56|0.0059
72388784|NCT00005044|144286008|SUPERIORITY||Hazard Ratio (HR)|0.96||||0.47|TWO_SIDED|95.0|0.85|1.08|||Log Rank|Significance level = 0.05|Reference level = TAS x 8 weeks|||1.08|0.85|0.47
72388785|NCT00005044|144286009|SUPERIORITY||Hazard Ratio (HR)|0.65||||0.07|TWO_SIDED|95.0|0.4|1.05|||Gray's test|2-sided significance level = 0.05|Reference level = TAS x 8 weeks|Locoregional progression||1.05|0.40|0.07
72388786|NCT00005044|144286009|SUPERIORITY||Hazard Ratio (HR)|1.07||||0.8|TWO_SIDED|95.0|0.68|1.66|||Gray's test|2-sided significance level = 0.05|Reference level = TAS x 8 weeks|Distant metastasis||1.66|0.68|0.80
72388787|NCT00005044|144286010|SUPERIORITY||Hazard Ratio (HR)|1.02||||0.74|TWO_SIDED|95.0|0.89|1.17|||Gray's test|2-sided significance level = 0.05|Reference level = TAS x 8 weeks|Protocol definition||1.17|0.89|0.74
72388788|NCT00005044|144286010|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.77|TWO_SIDED|95.0|0.79|1.19|||Gray's test|2-sided significance level = 0.05|Reference level = TAS x 8 weeks|Phoenix definition||1.19|0.79|0.77
72388789|NCT00005044|144286011|SUPERIORITY||Hazard Ratio (HR)|0.91||||0.62|TWO_SIDED|95.0|0.64|1.3|||Log Rank|2-sided significance level = 0.05|Reference level = TAS x 8 weeks|||1.30|0.64|0.62
72388790|NCT02935842|144286089|OTHER|||||||||||||||||First Reliable Change (RC), Reliable Change Index (RCI) were calculated on every individual score. Further, ANOVAs and t-tests were administered in order to verify differences between groups or interventions. Significance levels were set at p \< .05.|Reliable Change / Reliable Change Index according to Jacobson \& Truax (1991). There, on the basis of every individual score, the change in performance (i.e. BL-4Weeks/ BL-6Months) has been calculated and is reported with level of significance as well as effect size.|||
72388791|NCT02935842|144286089|OTHER|||||||0.05|||||||ANOVA|||||||.05
72388792|NCT02935842|144286093|OTHER|||||||0.05|||||||ANOVA|||||||.05
72388793|NCT02935842|144286095|OTHER|||||||0.05|||||||ANOVA|||||||.05
72388794|NCT02774954|144286102|SUPERIORITY|||||||0.35|||||||ANOVA|||||||0.35
72388795|NCT02774954|144286103|SUPERIORITY|||||||0.35|||||||ANOVA|||||||0.35
72388796|NCT04545385|144286104|OTHER||Odds Ratio (OR)|1.49||||0.7817|TWO_SIDED|95.0|0.545|4.071|||Regression, Logistic|||Analysis was performed using logistic regression with fixed effects for treatment, baseline FEV1, weight, age group, and gender.||4.071|0.545|0.7817
72388797|NCT02168361|144286140|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED||||||Chi-squared|||Null hypothesis is no difference between two regimens in SVR-12.||||.02
72388798|NCT00758836|144286151|SUPERIORITY_OR_OTHER||Proportion difference|24.5|||<|0.001|TWO_SIDED|90.0|16.7|32.2|||Miettinen and Nurminen|Miettinen and Nurminen method for independent binomial distribution stratified by baseline severity.||||32.2|16.7|<0.001
72388799|NCT00758836|144286151|SUPERIORITY_OR_OTHER||Proportion difference|27.7|||<|0.001|TWO_SIDED|90.0|19.6|35.8|||Miettinen and Nurminen|Miettinen and Nurminen method for independent binomal distribution stratified by baseline severity.||||35.8|19.6|<0.001
72388800|NCT00758836|144286151|SUPERIORITY_OR_OTHER||Proportion difference|20.4|||<|0.001|TWO_SIDED|90.0|12.6|28.2|||Miettinen and Nurminen|Miettinen and Nurminen method for independent binomal distribution stratified by baseline severity.||||28.2|12.6|<0.001
72388801|NCT00758836|144286151|SUPERIORITY_OR_OTHER||Proportion differenece|4.2||||0.449|TWO_SIDED|90.0|-5.0|13.3|||Miettinen and Nurminen|Miettinen and Nurminen method for independent binomal distribution stratified by baseline severity.||||13.3|-5.0|0.449
72388802|NCT00758836|144286151|SUPERIORITY_OR_OTHER||Proportion difference|7.7||||0.182|TWO_SIDED|90.0|-1.8|17.1|||Miettinen and Nurminen|Miettinen and Nurminen method for independent binomal distribution stratified by baseline severity.||||17.1|-1.8|0.182
72388803|NCT00758836|144286152|SUPERIORITY_OR_OTHER||Proportion difference|40.8|||<|0.001|TWO_SIDED|90.0|31.9|49.0|||Miettinen and Nurminen|Miettinen and Nurminen method for independent binomal distribution stratified by baseline severity.||||49.0|31.9|<0.001
72388804|NCT00758836|144286152|SUPERIORITY_OR_OTHER||Proportion difference|39.9|||<|0.001|TWO_SIDED|90.0|30.5|48.5|||Miettinen and Nurminen|Miettinen and Nurminen method for independent binomal distribution stratified by baseline severity.||||48.5|30.5|<0.001
72388805|NCT00758836|144286152|SUPERIORITY_OR_OTHER||Proportion difference|6.1||||0.265|TWO_SIDED|90.0|-2.9|14.9|||Miettinen and Nurminen|Miettinen and Nurminen method for independent binomal distribution stratified by baseline severity.||||14.9|-2.9|0.265
72388806|NCT00758836|144286152|SUPERIORITY_OR_OTHER||Proportion difference|5.2||||0.362|TWO_SIDED|90.0|-4.2|14.5|||Miettinen and Nurminen|Miettinen and Nurminen method for independent binomal distribution stratified by baseline severity.||||14.5|-4.2|0.362
72496943|NCT01070329|144523548|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.95|||<|0.001|TWO_SIDED|95.0|-1.47|-0.42||This is the p-value for the Disrupt Work/School Work score. The p-value is not adjusted for multiple comparisons.|Mixed Models Analysis|||||-0.42|-1.47|<0.001
72388807|NCT00758836|144286152|SUPERIORITY_OR_OTHER||Proportion difference|34.7|||<|0.001|TWO_SIDED|90.0|25.3|43.4|||Miettinen and Nurminen|Miettinen and Nurminen method for independent binomal distribution stratified by baseline severity.||||43.4|25.3|<0.001
72388808|NCT01817530|144286155|SUPERIORITY||Odds Ratio (OR)|32.51|||<|0.001|TWO_SIDED|95.0|11.12|95.05||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline as a covariate.|Regression, Logistic|||||95.05|11.12|< 0.001
72388809|NCT01817530|144286155|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a chi-square test.|Chi-squared|||||||< 0.001
72496944|NCT01070329|144523548|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.97|||<|0.001|TWO_SIDED|95.0|-1.42|-0.53||This the p-value for the Disrupt Social Life/Leisure score. The p-value is not adjusted for multiple comparisons.|Mixed Models Analysis|||||-0.53|-1.42|<0.001
72496945|NCT01070329|144523548|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.95|||<|0.001|TWO_SIDED|95.0|-1.41|-0.49||This is the p-value for the Disrupt Family Life/Home score. The p-value is not adjusted for multiple comparisons.|Mixed Models Analysis|||||-0.49|-1.41|<0.001
72496946|NCT01070329|144523548|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.88|||<|0.001|TWO_SIDED|95.0|-4.16|-1.61||P-value for the SDS Total score. First gated secondary outcome measure. Gatekeeper strategy controlled experiment-wise type I error for 5 secondary outcomes with stepwise comparisons of treatments until outcome failed to be significant (p\>0.05).|Mixed Models Analysis|||||-1.61|-4.16|<0.001
72443487|NCT04732494|144400539|OTHER||LS Mean Difference|-10.8|||||TWO_SIDED|95.0|-27.8|6.3||||||Analysis of Change from Baseline in Dysphagia at Cycle 7. The mixed effect model analysis included the questionnaire score as dependent variable; baseline score, stratification factors, treatment arm, visit, and treatment arm by visit interaction as fixed effects; and visit as a repeated measure, with an unstructured covariance structure.||6.3|-27.8|
72443488|NCT04732494|144400539|OTHER||LS Mean Difference|-0.4|||||TWO_SIDED|95.0|-7.3|6.6||||||Analysis of Change from Baseline in Eating at Cycle 5. The mixed effect model analysis included the questionnaire score as dependent variable; baseline score, stratification factors, treatment arm, visit, and treatment arm by visit interaction as fixed effects; and visit as a repeated measure, with an unstructured covariance structure.||6.6|-7.3|
72443489|NCT04732494|144400539|OTHER||LS Mean Difference|-9.4|||||TWO_SIDED|95.0|-18.5|-0.3||||||Analysis of Change from Baseline in Eating at Cycle 7. The mixed effect model analysis included the questionnaire score as dependent variable; baseline score, stratification factors, treatment arm, visit, and treatment arm by visit interaction as fixed effects; and visit as a repeated measure, with an unstructured covariance structure.||-0.3|-18.5|
72443490|NCT04732494|144400539|OTHER||LS Mean Difference|2.3|||||TWO_SIDED|95.0|-6.7|11.2||||||Analysis of Change from Baseline in Reflux at Cycle 5. The mixed effect model analysis included the questionnaire score as dependent variable; baseline score, stratification factors, treatment arm, visit, and treatment arm by visit interaction as fixed effects; and visit as a repeated measure, with an unstructured covariance structure.||11.2|-6.7|
72443491|NCT04732494|144400539|OTHER||LS Mean Difference|-1.4|||||TWO_SIDED|95.0|-11.8|9.0||||||Analysis of Change from Baseline in Reflux at Cycle 7. The mixed effect model analysis included the questionnaire score as dependent variable; baseline score, stratification factors, treatment arm, visit, and treatment arm by visit interaction as fixed effects; and visit as a repeated measure, with an unstructured covariance structure.||9.0|-11.8|
72496947|NCT01070329|144523549|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||This is the second gated secondary outcome measure. A gatekeeper strategy (Dmitrienko et al. 2003) controlled experiment-wise type I error for 5 secondary outcomes. Treatments were compared stepwise until an outcome failed to be significant (p\>0.05).|Cochran-Mantel-Haenszel|||||||<0.001
72443492|NCT04732494|144400539|OTHER||LS Mean Difference|0.7|||||TWO_SIDED|95.0|-7.0|8.5||||||Analysis of Change from Baseline in Pain at Cycle 5. The mixed effect model analysis included the questionnaire score as dependent variable; baseline score, stratification factors, treatment arm, visit, and treatment arm by visit interaction as fixed effects; and visit as a repeated measure, with an unstructured covariance structure.||8.5|-7.0|
72443493|NCT04732494|144400539|OTHER||LS Mean Difference|-5.3|||||TWO_SIDED|95.0|-12.3|1.7||||||Analysis of Change from Baseline in Pain at Cycle 7. The mixed effect model analysis included the questionnaire score as dependent variable; baseline score, stratification factors, treatment arm, visit, and treatment arm by visit interaction as fixed effects; and visit as a repeated measure, with an unstructured covariance structure.||1.7|-12.3|
72443494|NCT05485922|144400560|SUPERIORITY|Number of flow-stop episodes will be analysed, in a generalized linier mixed model, with subject included as a random component. Evidence of superior effect will be concluded, if the lower 95% confidence limit of the risk ratio between comparator and investigational device, is more than 1.|Risk Ratio (RR)|0.16|||<|0.05|TWO_SIDED|95.0|0.05|0.44|||Mixed Models Analysis|||||0.44|0.05|<0.05
72496948|NCT01070329|144523550|SUPERIORITY_OR_OTHER|||||||0.173||95.0||||This third gated secondary outcome measure failed to meet statistical significance. A gatekeeper strategy (Dmitrienko et al. 2003) controlled experiment-wise type I error for 5 secondary outcomes.|Cochran-Mantel-Haenszel|||||||0.173
72443495|NCT05485922|144400561|SUPERIORITY||Mean Difference (Final Values)|34.3||||0.05|TWO_SIDED|95.0|14.69|53.91||The pass criteria were based on results analysing the 2 primary endpoints in a hierarchical fashion: rejecting the H0 on the first endpoint (Residual urine at first flow-stop) before continuing to the second (Number of flow-stop episodes).|Mixed Models Analysis|||This was a superiority investigation in which the null hypothesis of the primary endpoints was to be rejected, at a 5% significance (alpha 0.05), to demonstrate the superiority of the investigational device.||53.91|14.69|0.05
72496949|NCT01070329|144523551|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.81|||||TWO_SIDED|95.0|-4.13|-1.48|||Mixed Models Analysis|Fourth gated secondary outcome measure. Statistical significance was not evaluated; prior gated secondary outcome measure failed (p\>0.05).||||-1.48|-4.13|
72496950|NCT01070329|144523552|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.67||||0.05|TWO_SIDED|95.0|0.0|3.34||This is the p-value for the Change at Week 8. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|||||3.34|0.00|0.050
72496951|NCT01070329|144523552|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.39||||0.071|TWO_SIDED|95.0|-0.12|2.9||This is the p-value for the Change up to Week 8. P-values were not adjusted for multiple comparisons; a priori statistical significance was 0.05.|ANCOVA|||||2.90|-0.12|0.071
72496952|NCT01070329|144523553|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.91||||0.05|TWO_SIDED|95.0|0.0|3.82||This is the p-value for the Change from Baseline in SBP at Week 8. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|||||3.82|0.00|0.050
72496953|NCT01070329|144523553|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.8||||0.007|TWO_SIDED|95.0|0.5|3.1||This is the p-value for the Change from Baseline in DBP at Week 8. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|||||3.10|0.50|0.007
72443496|NCT05485922|144400562|SUPERIORITY|The pass criteria were based on the results analysing the two primary endpoints in a hierarchical fashion: rejecting the null hypothesis on the first endpoint (Residual urine at first flow-stop) before continuing to the second (Number of flow-stop episodes).|Risk Ratio (RR)|0.16||||0.05|TWO_SIDED|95.0|0.05|0.44|||Mixed Models Analysis|||This was a superiority investigation in which the null hypothesis of the primary endpoints was to be rejected, at a 5% significance (alpha 0.05), to demonstrate the superiority of the investigational device.||0.44|0.05|0.05
72443497|NCT05485922|144400563|SUPERIORITY||Mean Difference (Final Values)|-95.69||||0.05|TWO_SIDED|95.0|-137.69|-53.7|||Mixed Models Analysis|||The intra-catheter pressure at flow stop was analysed in a general linear mixed model with subject included as a random component.||-53.70|-137.69|0.05
72443498|NCT05485922|144400564|OTHER||Mean Difference (Final Values)|1.21||||0.05|TWO_SIDED|95.0|-11.1|13.51|||Mixed Models Analysis|||||13.51|-11.10|0.05
72443499|NCT05485922|144400565|SUPERIORITY||Odds Ratio (OR)|0.26||||0.05|TWO_SIDED|95.0|0.07|0.96|||Mixed Models Analysis|||Analyzed using a generalized linear mixed model, modelling the probability of a positive outcome. Evidence of effect in favour of the MHZC was concluded if the upper 95% confidence limit (CL) of the odds ratio, O.R. was less than 1.||0.96|0.07|0.05
72443500|NCT05767437|144400594|EQUIVALENCE|effect size of 0.02, α \< 0.05, power = 0.02|Mean Difference (Net)|1.63||||0.98|TWO_SIDED|95.0|-55.79|59.05|||Mixed Models Analysis|||||59.05|-55.79|0.98
72443501|NCT05767437|144400595|EQUIVALENCE|an effect size of 0.00, α \< 0.05, power = 0.00|Mean Difference (Net)|0.0||||0.99|TWO_SIDED|95.0|-1.25|1.24|||Mixed Models Analysis|||||1.24|-1.25|0.99
72443502|NCT05767437|144400596|EQUIVALENCE|an effect size of 0.56 , α \< 0.05, power = 32.5|Mean Difference (Net)|6.71||||0.68|TWO_SIDED|95.0|-24.12|10.71|||Mixed Models Analysis|||||10.71|-24.12|0.68
72443503|NCT05767437|144400597|EQUIVALENCE|Analysis population description: patients were randomly assigned to either Group A or Group B|Mean Difference (Net)|0.2||||0.56|TWO_SIDED|95.0|-0.48|0.87|||Mixed Models Analysis|||an effect size of 0.24, α \< 0.05, power = 24.5||0.87|-0.48|0.56
72443504|NCT05767437|144400598|EQUIVALENCE|an effect size of 0.56, α \< 0.05, power = 57.9|Mean Difference (Net)|-250.35||||0.42|TWO_SIDED|95.0|-614.88|114.18||Interaction of Assessment and Group|Mixed Models Analysis|||||114.18|-614.88|0.42
72443505|NCT05767437|144400599|EQUIVALENCE|an effect size of 0.29, α \< 0.05, power = 88.9|Mean Difference (Net)|12.25||||0.45|TWO_SIDED|95.0|-18.67|43.17|||Mixed Models Analysis|||||43.17|-18.67|0.45
72496954|NCT01070329|144523553|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.7||||0.063|TWO_SIDED|95.0|-0.09|3.5||This is the p-value for the Change from Baseline in SBP up to Week 8. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|ANCOVA|||||3.50|-0.09|0.063
72496955|NCT01070329|144523553|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.81||||0.004|TWO_SIDED|95.0|0.6|3.02||This is the p-value for the Change from Baseline in DBP up to Week 8. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|ANCOVA|||||3.02|0.60|0.004
72443506|NCT05767437|144400600|EQUIVALENCE|an effect size of 0.18, α \< 0.05, power =6.5|mean rank (Z)|0.18||||0.67|TWO_SIDED|95.0|-0.61|0.96||MAS of Biceps|Wilcoxon (Mann-Whitney)|||||0.96|-0.61|0.67
72443507|NCT05767437|144400601|EQUIVALENCE|an effect size of 0.39, α \< 0.05, power = 16.2|Mean Difference (Net)|-6.63||||0.38|TWO_SIDED|95.0|-19.38|6.12|||t-test, 2 sided|||||6.12|-19.38|0.38
72443508|NCT02697136|144400610|OTHER|Linear mixed model to test for superiority and non-inferiority. Equivalence was defined as a difference of less than 6.7% in MVWA, based on a pilot study. Using an assumed standard deviation of 4.5% and a 2:1 randomization scheme to maximize exposure to active drug, 16 completing patients in the CER-001 group and 8 in the placebo group (24 total completers for mITT) would yield 90% power to detect a difference from baseline versus placebo of 6.7%, using two-tailed testing with α=0.05.|Difference in LS Means|-0.08||||0.185|TWO_SIDED|95.0|-1.9|0.4|||Mixed Models Analysis|||||0.4|-1.9|0.185
72443509|NCT02697136|144400611|OTHER|Linear mixed model to test for superiority and non-inferiority. Equivalence was defined as a difference of less than 6.7% in MVWA, based on a pilot study.|Difference in LS Means|0.7||||0.217|TWO_SIDED|95.0|-0.4|1.8|||Mixed Models Analysis|||||1.8|-0.4|0.217
72443510|NCT02697136|144400612|OTHER|Linear mixed model to test for superiority and non-inferiority. Equivalence was defined as a difference of less than 6.7% in MVWA, based on a pilot study.|Difference in LS Means|-0.2||||0.832|TWO_SIDED|95.0|-1.6|1.3|||Mixed Models Analysis|||||1.3|-1.6|0.832
72443511|NCT05198310|144400660|SUPERIORITY||LS Mean Difference|-0.57|STANDARD_ERROR_OF_MEAN|0.281||0.047|TWO_SIDED|95.0|-1.13|-0.01||Analyzed using ANCOVA model with baseline value and stratification factor (≤1 vs. ≥2 classes of advanced targeted therapies) as covariates.|ANCOVA|||||-0.01|-1.13|0.0470
72443512|NCT05198310|144400660|SUPERIORITY||LS Mean Difference|-0.36|STANDARD_ERROR_OF_MEAN|0.282||0.2124|TWO_SIDED|95.0|-0.92|0.21||Analyzed using ANCOVA model with baseline value and stratification factor (≤1 vs. ≥2 classes of advanced targeted therapies) as covariates.|ANCOVA|||||0.21|-0.92|0.2124
72443513|NCT05198310|144400660|SUPERIORITY||LS Mean Difference|-0.58|STANDARD_ERROR_OF_MEAN|0.352||0.1091|TWO_SIDED|95.0|-1.28|0.13||Analyzed using ANCOVA model with baseline value and stratification factor (≤1 vs. ≥2 classes of advanced targeted therapies) as covariates.|ANCOVA|||||0.13|-1.28|0.1091
72443514|NCT05198310|144400661|SUPERIORITY|||||||0.0312|||||||t-test|||||||0.0312
72443515|NCT05198310|144400661|SUPERIORITY|||||||0.0338|||||||t-test|||||||0.0338
72443516|NCT05198310|144400665|SUPERIORITY|||||||0.0333|||||||Fisher exact test|||||||0.0333
72443517|NCT05198310|144400665|SUPERIORITY|||||||0.1905|||||||Fisher exact test|||||||0.1905
72443518|NCT05198310|144400665|SUPERIORITY||Odds Ratio (OR)|2.95||||0.0716|TWO_SIDED|95.0|0.9|9.65|||Cochran-Mantel-Haenszel|||||9.65|0.90|0.0716
72443519|NCT05198310|144400665|SUPERIORITY||Odds Ratio (OR)|1.52||||0.471|TWO_SIDED|95.0|0.5|4.67|||Cochran-Mantel-Haenszel|||||4.67|0.50|0.4710
72443520|NCT05198310|144400665|SUPERIORITY||Odds Ratio (OR)|6.09||||0.0057|TWO_SIDED|95.0|1.62|22.88|||Cochran-Mantel-Haenszel|||||22.88|1.62|0.0057
72443521|NCT05198310|144400666|SUPERIORITY|||||||0.0762|||||||Fisher exact test|||||||0.0762
72443522|NCT05198310|144400666|SUPERIORITY|||||||1|||||||Fisher exact test|||||||1.000
72443523|NCT05198310|144400666|SUPERIORITY||Odds Ratio (OR)|1.67||||0.4172|TWO_SIDED|95.0|0.49|5.62|||Cochran-Mantel-Haenszel|||||5.62|0.49|0.4172
72443524|NCT05198310|144400666|SUPERIORITY||Odds Ratio (OR)|1.89||||0.3144|TWO_SIDED|95.0|0.55|6.45|||Cochran-Mantel-Haenszel|||||6.45|0.55|0.3144
72443525|NCT05198310|144400666|SUPERIORITY||Odds Ratio (OR)|0.97||||0.956|TWO_SIDED|95.0|0.28|3.39|||Cochran-Mantel-Haenszel|||||3.39|0.28|0.9560
72443526|NCT05198310|144400667|SUPERIORITY|||||||0.4667|||||||Fisher exact test|||||||0.4667
72443527|NCT05198310|144400667|SUPERIORITY|||||||1|||||||Fisher exact test|||||||1.0000
72443528|NCT05198310|144400667|SUPERIORITY||Odds Ratio (OR)|1.95||||0.5789|TWO_SIDED|95.0|0.17|22.3|||Cochran-Mantel-Haenszel|||||22.30|0.17|0.5789
72443529|NCT05198310|144400667|SUPERIORITY||Odds Ratio (OR)|6.12||||0.0799|TWO_SIDED|95.0|0.62|60.1|||Cochran-Mantel-Haenszel|||||60.10|0.62|0.0799
72443530|NCT05198310|144400667|SUPERIORITY||Odds Ratio (OR)|0.28||||0.1034|TWO_SIDED|95.0|0.06|1.35|||Cochran-Mantel-Haenszel|||||1.35|0.06|0.1034
72443531|NCT01095796|144400710|NON_INFERIORITY_OR_EQUIVALENCE|A total of 700 HIV-1 infected participants, randomized in a 1:1 ratio to 2 groups would achieve at least 95% power to establish noninferiority in Week 48 response (HIV-1 RNA \< 50 copies/mL per the FDA-defined snapshot analysis) rate difference between the 2 groups. For sample size and power computation, it was assumed that both treatment groups have a response rate of 0.795, a noninferiority margin of 0.12, and that the significance level of the test is at a one-sided, 0.025 level.|Difference in response rates|3.6|||||TWO_SIDED|95.2|-1.6|8.8|||||To preserve the overall alpha level: 0.05, accounting for 2 interim analyses for Independent Data Monitoring Committee meetings, the 95.2% CI was computed using normal approximation stratified by baseline HIV-1 RNA (≤ 100,000 or \> 100,000 copies/mL).|The null hypothesis was that the percentage of participants achieving HIV-1 RNA \< 50 copies/mL (as defined by the snapshot analysis algorithm) at Week 48 in the Stribild group is at least 12% worse than the response rate in the Atripla group; the alternative hypothesis was that the response rate in the Stribild group is less than 12% worse than that in the Atripla Group.||8.8|-1.6|
72443532|NCT02713126|144400790|SUPERIORITY|||||||0.77|||||||t-test, 2 sided|||||||0.770
72443533|NCT02713126|144400791|SUPERIORITY|||||||0.087|||||||t-test, 2 sided|||||||0.087
72443534|NCT02713126|144400792|SUPERIORITY|||||||0.538|||||||t-test, 2 sided|||||||0.538
72443535|NCT02713126|144400793|SUPERIORITY|||||||0.708|||||||t-test, 2 sided|||||||0.708
72443536|NCT02713126|144400794|SUPERIORITY|||||||0.496|||||||t-test, 2 sided|||||||0.496
72443537|NCT00100698|144400795|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-22.0|STANDARD_ERROR_OF_MEAN|6.0||0.049|TWO_SIDED|95.0|-38.0|-0.5|||repeated measures mixed effects ANCOVA|||||-0.5|-38|0.049
72443538|NCT00715884|144400825|NON_INFERIORITY_OR_EQUIVALENCE|The null inferiority hypothesis was that the upper limit of the 95% confidence interval is equal or greater than the non-inferiority margin 5%. The alternative non-inferiority hypothesis for this study assumed that the upper limit of the 95% confidence interval would be less than the non-inferiority margin 5%.|Difference between TLF rates|2.58|||||ONE_SIDED|95.0||5.55||In the CYPHER® ELITE™ arm the TLF rate was 5.36% (23/429) compared with 2.78% (6/216) in the CYPHER® Bx VELOCITY® arm, a difference in rates of 2.58%, upper limit of 95% two sided confidence interval of 5.55%.||||Sample sizes of 1,061 from the ELITE™ group and 531 from the CYPHER® group were planned to achieve 90 percent power at a 2.5 percent significance level using an one-sided equivalence test, assuming a 10 percent TLF rate in each group and the maximum allowable rate difference between the groups being 5 percent. The total sample size was increased to 1,770 patients to account for an approximately 90 percent compliance to clinical follow-up.||5.55||
72443539|NCT00715884|144400826|SUPERIORITY_OR_OTHER||Difference between event rates|-0.4||||0.549|TWO_SIDED|95.0|-1.3|1.0|||Fisher Exact|||||1.0|-1.3|0.549
72443540|NCT00715884|144400827|SUPERIORITY_OR_OTHER||Difference between event rates|13.8|||<|0.001|TWO_SIDED|95.0|9.2|18.9|||Fisher Exact|||||18.9|9.2|<.001
72443541|NCT00715884|144400828|SUPERIORITY_OR_OTHER||Difference between event rates|0.7||||0.724|TWO_SIDED|95.0|-2.2|4.2|||Fisher Exact|||||4.2|-2.2|0.724
72443542|NCT00715884|144400829|SUPERIORITY_OR_OTHER||Difference between event rates|-1.3||||0.407|TWO_SIDED|95.0|-3.5|1.4|||Fisher Exact|||||1.4|-3.5|0.407
72443543|NCT00715884|144400830|SUPERIORITY_OR_OTHER||Difference between event rates|2.11||||0.203|TWO_SIDED|95.0|-0.84|4.48|||Fisher Exact|||||4.48|-0.84|0.203
72443544|NCT00715884|144400831|SUPERIORITY_OR_OTHER||Difference between event rates|2.35||||0.22|TWO_SIDED|95.0|-1.24|5.28|||Fisher Exact|||||5.28|-1.24|0.22
72443545|NCT00715884|144400832|SUPERIORITY_OR_OTHER||Difference between event rates|2.83||||0.166|TWO_SIDED|95.0|-1.28|6.26|||Fisher Exact|||||6.26|-1.28|0.166
72496956|NCT01070329|144523554|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.07|||||TWO_SIDED|95.0|-3.18|-0.96|||Mixed Models Analysis|Fifth gated secondary outcome measure. Statistical significance was not evaluated; the third gated secondary outcome measure failed (p\>0.05).||||-0.96|-3.18|
72496957|NCT01070329|144523555|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.54||||0.007|TWO_SIDED|95.0|-0.93|-0.15||This is the p-value for the Change from Baseline at Week 8. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|||||-0.15|-0.93|0.007
72443546|NCT00715884|144400833|SUPERIORITY_OR_OTHER||Difference between event rates|2.59||||0.2|TWO_SIDED|95.0|-1.35|5.85|||Fisher Exact|||||5.85|-1.35|0.200
72443547|NCT00715884|144400834|SUPERIORITY_OR_OTHER||Difference between event rates|11.56||||0.14|TWO_SIDED|95.0|-3.73|24.64|||Fisher Exact|||||24.64|-3.73|0.140
72443548|NCT00715884|144400835|SUPERIORITY_OR_OTHER||Difference between event rates|5.17||||0.17|TWO_SIDED|95.0|-2.03|10.83|||Fisher Exact|||||10.83|-2.03|0.170
72443549|NCT00715884|144400836|SUPERIORITY_OR_OTHER||Difference between event rates|0.24||||1|TWO_SIDED|95.0|-5.61|5.43|||Fisher Exact|||||5.43|-5.61|1.0
72443550|NCT00715884|144400837|SUPERIORITY_OR_OTHER||Difference between event rates|0.24||||1|TWO_SIDED|95.0|-1.92|1.63|||Fisher Exact|||||1.63|-1.92|1.0
72443551|NCT00715884|144400838|SUPERIORITY_OR_OTHER||Difference between event rates|0.49||||0.801|TWO_SIDED|95.0|-2.73|2.91|||Fisher Exact|||||2.91|-2.73|0.801
72443552|NCT00715884|144400839|SUPERIORITY_OR_OTHER||Difference between event rates|-0.92||||0.341|TWO_SIDED|95.0|-3.56|0.6|||Fisher Exact|||||0.60|-3.56|0.341
72443553|NCT00715884|144400840|SUPERIORITY_OR_OTHER||Difference between event rates|0.0||||1|TWO_SIDED|95.0|-2.14|1.28|||Fisher Exact|||||1.28|-2.14|1.00
72443554|NCT00715884|144400841|SUPERIORITY_OR_OTHER||Difference between event rates|0.47||||0.668|TWO_SIDED|95.0|-1.72|1.96|||Fisher Exact|||||1.96|-1.72|0.668
72496958|NCT01070329|144523555|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.57||||0.002|TWO_SIDED|95.0|-0.93|-0.22||This is the p-value for the Change from Baseline up to Week 8. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|ANCOVA|||||-0.22|-0.93|0.002
72496959|NCT01070329|144523556|SUPERIORITY_OR_OTHER|||||||0.021||95.0||||P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|Fisher Exact|||||||0.021
72496960|NCT01070329|144523557|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.56|||<|0.001|TWO_SIDED|95.0|-0.85|-0.27||This is the p-value for the main effect of treatment for the BPI Severity for Worst Pain score. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|||||-0.27|-0.85|<0.001
72496961|NCT01070329|144523557|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.38||||0.003|TWO_SIDED|95.0|-0.64|-0.13||This is the p-value for main effect of treatment for the BPI Severity for Least Pain score. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|||||-0.13|-0.64|0.003
72496962|NCT01070329|144523557|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.49|||<|0.001|TWO_SIDED|95.0|-0.75|-0.22||This is the p-value for the main effect of treatment for the BPI Severity for Average Pain score. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|||||-0.22|-0.75|<0.001
72496963|NCT01070329|144523557|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.56|||<|0.001|TWO_SIDED|95.0|-0.86|-0.27||This is the p-value for the main effect of treatment for the BPI Severity for Pain Right Now score. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|||||-0.27|-0.86|<0.001
72496964|NCT01070329|144523557|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.43||||0.008|TWO_SIDED|95.0|-0.75|-0.11||This is the p-value for the main effect of treatment for the BPI Pain Interference with General Activity score. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|||||-0.11|-0.75|0.008
72496965|NCT01070329|144523557|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.48||||0.004|TWO_SIDED|95.0|-0.8|-0.15||This is the p-value for the main effect of treatment for the BPI Pain Interference with Mood score. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|||||-0.15|-0.80|0.004
72496966|NCT01070329|144523557|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.42||||0.006|TWO_SIDED|95.0|-0.72|-0.12||This is the p-value for the main effect of treatment for the BPI Pain Interference with Walking Ability Score. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|||||-0.12|-0.72|0.006
72496967|NCT01070329|144523557|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4||||0.012|TWO_SIDED|95.0|-0.72|-0.09||This is the p-value for the main effect of treatment for the BPI Pain Interference with Normal Work score. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|||||-0.09|-0.72|0.012
72496968|NCT01070329|144523557|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.37||||0.029|TWO_SIDED|95.0|-0.7|-0.04||This is the p-value for the main effect of treatment for the BPI Pain Interference with Relations with Others score. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|||||-0.04|-0.70|0.029
72560086|NCT00660387|144650677|SUPERIORITY_OR_OTHER||Treatment Difference (LS Mean)|-7.0|STANDARD_ERROR_OF_MEAN|2.8||0.0155|TWO_SIDED|95.0|-12.6|-1.4||Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the CGI-Severity (CGI-S, see Baseline Characteristics module) as a covariate.|ANCOVA|||Since the null hypothesis for the primary analysis was rejected in favor of the alternative hypothesis, hierarchical testing was performed for secondary variables on the Full Analysis data set at the 0.50 level using a gatekeeping procedure to preserve family-wise error rate.||-1.4|-12.6|0.0155
72388810|NCT01817530|144286155|SUPERIORITY||Odds Ratio (OR)|16.66|||<|0.001|TWO_SIDED|95.0|6.72|41.3||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline as a covariate.|Regression, Logistic|||||41.3|6.72|< 0.001
72496969|NCT01070329|144523557|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.39||||0.037|TWO_SIDED|95.0|-0.75|-0.02||This is the p-value for the main effect of treatment for the BPI Pain Interference with Sleep score. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|||||-0.02|-0.75|0.037
72496970|NCT01070329|144523557|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.47||||0.006|TWO_SIDED|95.0|-0.81|-0.14||This is the p-value for the main effect of treatment for the BPI Pain Interference with Enjoyment of Life score. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|||||-0.14|-0.81|0.006
72496971|NCT01070329|144523557|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.44||||0.004|TWO_SIDED|95.0|-0.74|-0.15||This is the p-value for the main effect of treatment for the BPI Interference score. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|||||-0.15|-0.74|0.004
72496972|NCT01070329|144523558|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7|||<|0.001|TWO_SIDED|95.0|-0.9|-0.49||P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|||||-0.49|-0.90|<0.001
72496973|NCT01070329|144523559|SUPERIORITY_OR_OTHER|||||||0.116||95.0||||This is the p-value for Suicidal Ideation. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|Fisher Exact|||||||0.116
72496974|NCT06062264|144523564|SUPERIORITY||Adjusted Risk Ratio|1.03|||||TWO_SIDED|95.0|1.0|1.06||||||Comparing the risk of receiving an influenza vaccination|Adjusted risk ratio. These results compare arms which received portal-based PCP video reminder messages to the arm receiving standard health system portal messages (control).|1.06|1.00|
72443555|NCT02412748|144400888|SUPERIORITY|||||||0.962|||||||ANCOVA|||Data were analyzed using a 3 × 2 repeated measures analysis of covariance (RM-ANCOVA) with 3 assessments crossed with two treatment conditions (BBTF and FLP). Five variables were included as covariates: father's age, father's highest level of education, number of members in father's social network, number of adults in the household, and sex of the target child. The effect of interest was the condition x time interaction.||||.962
72443556|NCT02412748|144400889|SUPERIORITY|||||||0.982|||||||ANCOVA|||Data were analyzed using a 3 × 2 repeated measures analysis of covariance (RM-ANCOVA) with 3 assessments crossed with two treatment conditions (BBTF and FLP). Five variables were included as covariates: father's age, father's highest level of education, number of members in father's social network, number of adults in the household, and sex of the target child. The effect of interest was the condition x time interaction.||||.982
72443557|NCT02412748|144400890|SUPERIORITY|||||||0.534|||||||ANCOVA|||Data were analyzed using a 3 × 2 repeated measures analysis of covariance (RM-ANCOVA) with 3 assessments crossed with two treatment conditions (BBTF and FLP). Five variables were included as covariates: father's age, father's highest level of education, number of members in father's social network, number of adults in the household, and sex of the target child. The effect of interest was the condition x time interaction.||||.534
72443558|NCT02412748|144400891|SUPERIORITY|||||||0.73|||||||ANCOVA|||Data were analyzed using a 3 × 2 repeated measures analysis of covariance (RM-ANCOVA) with 3 assessments crossed with two treatment conditions (BBTF and FLP). Five variables were included as covariates: father's age, father's highest level of education, number of members in father's social network, number of adults in the household, and sex of the target child. The effect of interest was the condition x time interaction.||||.730
72443559|NCT02412748|144400892|SUPERIORITY|||||||0.927|||||||ANCOVA|||Data were analyzed using a 3 × 2 repeated measures analysis of covariance (RM-ANCOVA) with 3 assessments crossed with two treatment conditions (BBTF and FLP). Five variables were included as covariates: father's age, father's highest level of education, number of members in father's social network, number of adults in the household, and sex of the target child. The effect of interest was the condition x time interaction.||||.927
72443560|NCT02412748|144400893|SUPERIORITY|||||||0.841|||||||ANCOVA|||Data were analyzed using a 3 × 2 repeated measures analysis of covariance (RM-ANCOVA) with 3 assessments crossed with two treatment conditions (BBTF and FLP). Five variables were included as covariates: father's age, father's highest level of education, number of members in father's social network, number of adults in the household, and sex of the target child. The effect of interest was the condition x time interaction.||||.841
72443561|NCT02412748|144400894|SUPERIORITY|||||||0.722|||||||ANCOVA|||Data were analyzed using a 3 × 2 repeated measures analysis of covariance (RM-ANCOVA) with 3 assessments crossed with two treatment conditions (BBTF and FLP). Five variables were included as covariates: father's age, father's highest level of education, number of members in father's social network, number of adults in the household, and sex of the target child. The effect of interest was the condition x time interaction.||||.722
72443562|NCT02412748|144400895|SUPERIORITY|||||||0.715|||||||ANCOVA|||Data were analyzed using a 3 × 2 repeated measures analysis of covariance (RM-ANCOVA) with 3 assessments crossed with two treatment conditions (BBTF and FLP). Five variables were included as covariates: father's age, father's highest level of education, number of members in father's social network, number of adults in the household, and sex of the target child. The effect of interest was the condition x time interaction.||||.715
72443563|NCT02412748|144400896|SUPERIORITY|||||||0.9|||||||ANCOVA|||Data were analyzed using a 3 × 2 repeated measures analysis of covariance (RM-ANCOVA) with 3 assessments crossed with two treatment conditions (BBTF and FLP). Five variables were included as covariates: father's age, father's highest level of education, number of members in father's social network, number of adults in the household, and sex of the target child. The effect of interest was the condition x time interaction.||||.900
72443564|NCT02412748|144400897|SUPERIORITY|||||||0.271|||||||ANCOVA|||Data were analyzed using a 3 × 2 repeated measures analysis of covariance (RM-ANCOVA) with 3 assessments crossed with two treatment conditions (BBTF and FLP). Five variables were included as covariates: father's age, father's highest level of education, number of members in father's social network, number of adults in the household, and sex of the target child. The effect of interest was the condition x time interaction.||||.271
72443565|NCT02412748|144400898|SUPERIORITY|||||||0.987|||||||ANCOVA|||Data were analyzed using a 3 × 2 repeated measures analysis of covariance (RM-ANCOVA) with 3 assessments crossed with two treatment conditions (BBTF and FLP). Five variables were included as covariates: father's age, father's highest level of education, number of members in father's social network, number of adults in the household, and sex of the target child. The effect of interest was the condition x time interaction.||||.987
72443566|NCT02412748|144400899|SUPERIORITY|||||||0.967|||||||ANCOVA|||Data were analyzed using a 3 × 2 repeated measures analysis of covariance (RM-ANCOVA) with 3 assessments crossed with two treatment conditions (BBTF and FLP). Five variables were included as covariates: father's age, father's highest level of education, number of members in father's social network, number of adults in the household, and sex of the target child. The effect of interest was the condition x time interaction.||||.967
72443567|NCT02412748|144400900|SUPERIORITY|||||||0.693|||||||ANCOVA|||Data were analyzed using a 3 × 2 repeated measures analysis of covariance (RM-ANCOVA) with 3 assessments crossed with two treatment conditions (BBTF and FLP). Five variables were included as covariates: father's age, father's highest level of education, number of members in father's social network, number of adults in the household, and sex of the target child. The effect of interest was the condition x time interaction.||||.693
72443568|NCT02412748|144400901|SUPERIORITY|||||||0.557|||||||ANCOVA|||Data were analyzed using a 3 × 2 repeated measures analysis of covariance (RM-ANCOVA) with 3 assessments crossed with two treatment conditions (BBTF and FLP). Five variables were included as covariates: father's age, father's highest level of education, number of members in father's social network, number of adults in the household, and sex of the target child. The effect of interest was the condition x time interaction.||||.557
72443569|NCT02412748|144400902|SUPERIORITY|||||||0.681|||||||ANCOVA|||Data were analyzed using a 3 × 2 repeated measures analysis of covariance (RM-ANCOVA) with 3 assessments crossed with two treatment conditions (BBTF and FLP). Five variables were included as covariates: father's age, father's highest level of education, number of members in father's social network, number of adults in the household, and sex of the target child. The effect of interest was the condition x time interaction.||||.681
72496975|NCT06062264|144523564|SUPERIORITY||Adjusted Risk Ratio|1.02|||||TWO_SIDED|95.0|0.99|1.06|||||Adjusted risk ratio. These results compare arms which received portal-based PCP video reminder messages to the arm receiving standard health system portal messages (control).|Comparing the risk of receiving an influenza vaccination||1.06|0.99|
72496976|NCT04233229|144523616|SUPERIORITY|Analysis of covariance (ANCOVA) model adjusted on the HbA1c stratification factor and Time In Range (TIR) at baseline (during the last 14 days completed continuous glucose monitor recording at the end of the study selection period)|Adjusted means difference|27.4|STANDARD_ERROR_OF_MEAN|6.0|<|0.001|TWO_SIDED|95.0|15.0|39.8||Study group effect|ANCOVA||Between-group adjusted means difference is calculated as analysis of covariance adjusted mean in Intervention Group - adjusted mean in Usual Care Group.|||39.8|15.0|<.001
72496977|NCT04233229|144523617|SUPERIORITY|Analysis of covariance (ANCOVA) model adjusted on the HbA1c stratification factor and Time In Range (TIR) during diurnal period at baseline (during the last 14 days completed continuous glucose monitor recording at the end of the study selection period)|Adjusted means difference|23.0|STANDARD_ERROR_OF_MEAN|6.0|<|0.001|TWO_SIDED|95.0|10.6|35.5||Study group effect|ANCOVA||Between-group adjusted means difference is calculated as analysis of covariance adjusted mean in Intervention Group - adjusted mean in Usual Care Group.|||35.5|10.6|<.001
72496978|NCT04233229|144523618|SUPERIORITY|Analysis of covariance (ANCOVA) model adjusted on the HbA1c stratification factor and Time In Range (TIR) during nocturnal period at baseline (during the last 14 days completed continuous glucose monitor recording at the end of the study selection period)|Adjusted means difference|40.8|STANDARD_ERROR_OF_MEAN|7.2|<|0.001|TWO_SIDED|95.0|25.8|55.8||Study group effect|ANCOVA||Between-group adjusted means difference is calculated as analysis of covariance adjusted mean in Intervention Group - adjusted mean in Usual Care Group.|||55.8|25.8|<.001
72496979|NCT04233229|144523619|SUPERIORITY|Analysis of covariance (ANCOVA) model adjusted on the HbA1c stratification factor and Time Above Range (TAR) at baseline (during the last 14 days completed continuous glucose monitor recording at the end of the study selection period)|Adjusted means difference|-27.7|STANDARD_ERROR_OF_MEAN|6.1|<|0.001|TWO_SIDED|95.0|-40.5|-15.0||Study group effect|ANCOVA||Between-group adjusted means difference is calculated as analysis of covariance adjusted mean in Intervention Group - adjusted mean in Usual Care Group.|||-15.0|-40.5|<.001
72496980|NCT04233229|144523620|SUPERIORITY|Analysis of covariance (ANCOVA) model adjusted on the HbA1c stratification factor and Time Above Range (TAR) at baseline (during the last 14 days completed continuous glucose monitor recording at the end of the study selection period)|Adjusted means difference|-20.1|STANDARD_ERROR_OF_MEAN|5.9||0.003|TWO_SIDED|95.0|-32.4|-7.9||Study group effect|ANCOVA||Between-group adjusted means difference is calculated as analysis of covariance adjusted mean in Intervention Group - adjusted mean in Usual Care Group.|||-7.9|-32.4|0.003
72496981|NCT04233229|144523621|SUPERIORITY|Analysis of covariance (ANCOVA) model adjusted on the HbA1c stratification factor and Time Below Range (TBR) at baseline (during the last 14 days completed continuous glucose monitor recording at the end of the study selection period)|Adjusted means difference|0.1|STANDARD_ERROR_OF_MEAN|0.5||0.79|TWO_SIDED|95.0|-1.0|1.3||Study group effect|ANCOVA||Between-group adjusted means difference is calculated as analysis of covariance adjusted mean in Intervention Group - adjusted mean in Usual Care Group.|||1.3|-1.0|0.79
72496982|NCT04233229|144523622|SUPERIORITY|Analysis of covariance (ANCOVA) model adjusted on the HbA1c stratification factor and Time Below Range (TBR) at baseline (during the last 14 days completed continuous glucose monitor recording at the end of the study selection period)|Adjusted means difference|0.0|STANDARD_ERROR_OF_MEAN|0.2||0.84|TWO_SIDED|95.0|-0.3|0.4||Study group effect|ANCOVA||Between-group adjusted means difference is calculated as analysis of covariance adjusted mean in Intervention Group - adjusted mean in Usual Care Group.|||0.4|-0.3|0.84
72496983|NCT04233229|144523623|SUPERIORITY|Analysis of covariance (ANCOVA) model adjusted on the HbA1c stratification factor and glucose variability (% CV Coefficient of Variation) at baseline (during the last 14 days completed continuous glucose monitor recording at the end of the study selection period)|Adjusted means difference|3.7|STANDARD_ERROR_OF_MEAN|1.9||0.06|TWO_SIDED|95.0|-0.2|7.6||Study group effect|ANCOVA||Between-group adjusted means difference is calculated as analysis of covariance adjusted mean in Intervention Group - adjusted mean in Usual Care Group.|||7.6|-0.2|0.060
72496984|NCT04233229|144523624|SUPERIORITY|Analysis of covariance (ANCOVA) model with 2 factors: HbA1c value at baseline and study group|Adjusted means difference|-1.3|STANDARD_ERROR_OF_MEAN|0.3|<|0.001|TWO_SIDED|95.0|-1.9|-0.7||Study group effect|ANCOVA||Between-group adjusted means difference is calculated as analysis of covariance adjusted mean in Intervention Group - adjusted mean in Usual Care Group.|||-0.7|-1.9|<.001
72560087|NCT00660387|144650678|SUPERIORITY_OR_OTHER||Treatment Difference (LS Mean)|-0.7|STANDARD_ERROR_OF_MEAN|0.3||0.0258|TWO_SIDED|95.0|-1.4|-0.1|||ANCOVA|Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the baseline CGI-S as a covariate.||Since the null hypothesis for the primary analysis was rejected in favor of the alternative hypothesis, hierarchical testing was performed for secondary variables on the Full Analysis data set at the 0.50 level using a gatekeeping procedure to preserve family-wise error rate.||-0.1|-1.4|0.0258
72388811|NCT01817530|144286155|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a chi-square test.|Chi-squared|||||||< 0.001
72496985|NCT04233229|144523625|SUPERIORITY|Analysis of covariance (ANCOVA) model adjusted on the HbA1c stratification factor and total daily insulin dose at selection|Adjusted means difference|-18.5|STANDARD_ERROR_OF_MEAN|28.5||0.52|TWO_SIDED|95.0|-78.2|41.2||Study group effect|ANCOVA||Between-group adjusted means difference is calculated as analysis of covariance adjusted mean in Intervention Group - adjusted mean in Usual Care Group.|||41.2|-78.2|0.52
72504707|NCT00685178|144540145|SUPERIORITY||Spearmann's rank correlation|0.969|||<|0.001|TWO_SIDED||||||ANOVA||CR subjects only|Analyses were performed to measure the correlation between CR groups (topiramate + CR and Placebo + CR) and abstinence.||||<0.001
72504708|NCT00685178|144540145|SUPERIORITY||Spearmann's rank correlation|0.494|||<|0.001|TWO_SIDED||||||Generalized Estimating Equation (GEE)||NonCR subjects only|Analyses were performed to measure the correlation between Non-CR groups (topiramate + NonCR and Placebo + NonCR) and abstinence.||||<0.001
72496986|NCT04233229|144523626|SUPERIORITY|Analysis of covariance (ANCOVA) model adjusted on the HbA1c stratification factor and body weight at study initiation visit|Adjusted means difference|2.8|STANDARD_ERROR_OF_MEAN|1.6||0.08|TWO_SIDED|95.0|-0.4|6.1||Study group effect|ANCOVA||Between-group adjusted means difference is calculated as analysis of covariance adjusted mean in Intervention Group - adjusted mean in Usual Care Group.|||6.1|-0.4|0.08
72496987|NCT02631538|144523647|OTHER||Least square (LS) mean difference|-2.86|STANDARD_ERROR_OF_MEAN|1.758|||TWO_SIDED|95.0|-6.38|0.67|||||Week 12. Analysis was performed using mixed effects repeated measures model, with Baseline, treatment, visit and interactions of visit with treatment as fixed effects and participant as a random effect.|||0.67|-6.38|
72496988|NCT02631538|144523647|OTHER||LS mean difference|-0.99|STANDARD_ERROR_OF_MEAN|1.382|||TWO_SIDED|95.0|-3.75|1.78|||||Week 12. Analysis was performed using mixed effects repeated measures model, with Baseline, treatment, visit and interactions of visit with treatment as fixed effects and participant as a random effect.|||1.78|-3.75|
72496989|NCT02631538|144523647|OTHER||LS mean difference|-0.63|STANDARD_ERROR_OF_MEAN|1.442|||TWO_SIDED|95.0|-3.52|2.26|||||Week 12. Analysis was performed using mixed effects repeated measures model, with Baseline, treatment, visit and interactions of visit with treatment as fixed effects and participant as a random effect.|||2.26|-3.52|
72496990|NCT02631538|144523647|OTHER||LS mean difference|-1.87|STANDARD_ERROR_OF_MEAN|1.732|||TWO_SIDED|95.0|-5.34|1.6|||||Week 12. Analysis was performed using mixed effects repeated measures model, with Baseline, treatment, visit and interactions of visit with treatment as fixed effects and participant as a random effect.|||1.60|-5.34|
72496991|NCT02631538|144523647|OTHER||LS mean difference|0.35|STANDARD_ERROR_OF_MEAN|1.422|||TWO_SIDED|95.0|-2.5|3.2|||||Week 12. Analysis was performed using mixed effects repeated measures model, with Baseline, treatment, visit and interactions of visit with treatment as fixed effects and participant as a random effect.|||3.20|-2.50|
72496992|NCT02631538|144523647|OTHER||LS mean difference|-2.45|STANDARD_ERROR_OF_MEAN|1.607|||TWO_SIDED|95.0|-5.67|0.77|||||Week 24. Analysis was performed using mixed effects repeated measures model, with Baseline, treatment, visit and interactions of visit with treatment as fixed effects and participant as a random effect.|||0.77|-5.67|
72496993|NCT02631538|144523647|OTHER||LS mean difference|-1.46|STANDARD_ERROR_OF_MEAN|1.265|||TWO_SIDED|95.0|-3.99|1.08|||||Week 24. Analysis was performed using mixed effects repeated measures model, with Baseline, treatment, visit and interactions of visit with treatment as fixed effects and participant as a random effect.|||1.08|-3.99|
72388812|NCT01817530|144286155|SUPERIORITY||Odds Ratio (OR)|11.13|||<|0.001|TWO_SIDED|95.0|4.79|25.84||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline as a covariate.|Regression, Logistic|||||25.84|4.79|< 0.001
72388813|NCT01817530|144286155|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a chi-square test.|Chi-squared|||||||< 0.001
72388814|NCT01817530|144286155|SUPERIORITY||Odds Ratio (OR)|19.62|||<|0.001|TWO_SIDED|95.0|7.81|49.27||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline as a covariate.|Regression, Logistic|||||49.27|7.81|< 0.001
72388815|NCT01817530|144286155|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a chi-square test.|Chi-squared|||||||< 0.001
72388816|NCT01817530|144286155|SUPERIORITY||Odds Ratio (OR)|6.02|||<|0.001|TWO_SIDED|95.0|2.95|12.3||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline as a covariate.|Regression, Logistic|||||12.3|2.95|< 0.001
72388817|NCT01817530|144286155|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a chi-square test.|Chi-squared|||||||< 0.001
72388818|NCT01817530|144286155|SUPERIORITY||Odds Ratio (OR)|10.34|||<|0.001|TWO_SIDED|95.0|4.79|22.34||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline as a covariate.|Regression, Logistic|||||22.34|4.79|< 0.001
72388819|NCT01817530|144286155|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a chi-square test.|Chi-squared|||||||< 0.001
72388820|NCT01817530|144286156|SUPERIORITY||Odds Ratio (OR)|156.17|||<|0.001|TWO_SIDED|95.0|38.04|641.22||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline as a covariate.|Regression, Logistic|||||641.22|38.04|< 0.001
72388821|NCT01817530|144286156|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a chi-square test.|Chi-squared|||||||< 0.001
72388822|NCT01817530|144286156|SUPERIORITY||Odds Ratio (OR)|66.07|||<|0.001|TWO_SIDED|95.0|21.1|206.88||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline as a covariate.|Regression, Logistic|||||206.88|21.1|< 0.001
72388823|NCT01817530|144286156|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a chi-square test.|Chi-squared|||||||< 0.001
72388824|NCT01817530|144286156|SUPERIORITY||Odds Ratio (OR)|52.15|||<|0.001|TWO_SIDED|95.0|17.42|156.09||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline as a covariate.|Regression, Logistic|||||156.09|17.42|< 0.001
72388825|NCT01817530|144286156|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a chi-square test.|Chi-squared|||||||< 0.001
72388826|NCT01817530|144286156|SUPERIORITY||Odds Ratio (OR)|25.45|||<|0.001|TWO_SIDED|95.0|10.45|61.96||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline as a covariate.|Regression, Logistic|||||61.96|10.45|< 0.001
72388827|NCT01817530|144286156|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a chi-square test.|Chi-squared|||||||< 0.001
72496994|NCT02631538|144523647|OTHER||LS mean difference|-0.07|STANDARD_ERROR_OF_MEAN|1.305|||TWO_SIDED|95.0|-2.68|2.55|||||Week 24. Analysis was performed using mixed effects repeated measures model, with Baseline, treatment, visit and interactions of visit with treatment as fixed effects and participant as a random effect.|||2.55|-2.68|
72443570|NCT02412748|144400903|SUPERIORITY|||||||0.389|||||||ANCOVA|||Data were analyzed using a 3 × 2 repeated measures analysis of covariance (RM-ANCOVA) with 3 assessments crossed with two treatment conditions (BBTF and FLP). Five variables were included as covariates: father's age, father's highest level of education, number of members in father's social network, number of adults in the household, and sex of the target child. The effect of interest was the condition x time interaction.||||.389
72443571|NCT02412748|144400904|SUPERIORITY|||||||0.846|||||||ANCOVA|||Data were analyzed using a 3 × 2 repeated measures analysis of covariance (RM-ANCOVA) with 3 assessments crossed with two treatment conditions (BBTF and FLP). Five variables were included as covariates: father's age, father's highest level of education, number of members in father's social network, number of adults in the household, and sex of the target child. The effect of interest was the condition x time interaction.||||.846
72443572|NCT02412748|144400905|SUPERIORITY|||||||0.871|||||||ANCOVA|||Data were analyzed using a 3 × 2 repeated measures analysis of covariance (RM-ANCOVA) with 3 assessments crossed with two treatment conditions (BBTF and FLP). Five variables were included as covariates: father's age, father's highest level of education, number of members in father's social network, number of adults in the household, and sex of the target child. The effect of interest was the condition x time interaction.||||.871
72443573|NCT02412748|144400906|SUPERIORITY|||||||0.986|||||||ANCOVA|||Data were analyzed using a 3 × 2 repeated measures analysis of covariance (RM-ANCOVA) with 3 assessments crossed with two treatment conditions (BBTF and FLP). Five variables were included as covariates: father's age, father's highest level of education, number of members in father's social network, number of adults in the household, and sex of the target child. The effect of interest was the condition x time interaction.||||.986
72443574|NCT02412748|144400907|SUPERIORITY|||||||0.791|||||||ANCOVA|||||||.791
72443575|NCT02412748|144400908|SUPERIORITY|||||||0.583|||||||ANCOVA|||||||.583
72443576|NCT02412748|144400909|SUPERIORITY|||||||0.851|||||||ANCOVA|||||||.851
72496995|NCT02631538|144523647|OTHER||LS mean difference|-1.0|STANDARD_ERROR_OF_MEAN|1.584|||TWO_SIDED|95.0|-4.17|2.18|||||Week 24. Analysis was performed using mixed effects repeated measures model, with Baseline, treatment, visit and interactions of visit with treatment as fixed effects and participant as a random effect.|||2.18|-4.17|
72496996|NCT02631538|144523647|OTHER||LS mean difference|1.39|STANDARD_ERROR_OF_MEAN|1.29|||TWO_SIDED|95.0|-1.2|3.97|||||Week 24. Analysis was performed using mixed effects repeated measures model, with Baseline, treatment, visit and interactions of visit with treatment as fixed effects and participant as a random effect.|||3.97|-1.20|
72443577|NCT03069313|144400911|OTHER|Paired t-test|||||<|0.0001|||||||t-test, 1 sided|||||||<0.0001
72443578|NCT03069313|144400912|OTHER|||||||0.0003|||||||t-test, 2 sided|||||||0.0003
72443579|NCT03069313|144400913|OTHER|This analysis is comparing SWB before and after treatment.||||||0.133|||||||t-test, 2 sided|||||||0.133
72496997|NCT02631538|144523647|OTHER||LS mean difference|-0.97|STANDARD_ERROR_OF_MEAN|1.845|||TWO_SIDED|95.0|-4.66|2.73|||||Week 36. Analysis was performed using mixed effects repeated measures model, with Baseline, treatment, visit and interactions of visit with treatment as fixed effects and participant as a random effect.|||2.73|-4.66|
72496998|NCT02631538|144523647|OTHER||LS mean difference|0.15|STANDARD_ERROR_OF_MEAN|1.449|||TWO_SIDED|95.0|-2.76|3.05|||||Week 36. Analysis was performed using mixed effects repeated measures model, with Baseline, treatment, visit and interactions of visit with treatment as fixed effects and participant as a random effect.|||3.05|-2.76|
72496999|NCT02631538|144523647|OTHER||LS mean difference|0.85|STANDARD_ERROR_OF_MEAN|1.498|||TWO_SIDED|95.0|-2.15|3.86|||||Week 36. Analysis was performed using mixed effects repeated measures model, with Baseline, treatment, visit and interactions of visit with treatment as fixed effects and participant as a random effect.|||3.86|-2.15|
72497000|NCT02631538|144523647|OTHER||LS mean difference|-1.11|STANDARD_ERROR_OF_MEAN|1.817|||TWO_SIDED|95.0|-4.76|2.53|||||Week 36. Analysis was performed using mixed effects repeated measures model, with Baseline, treatment, visit and interactions of visit with treatment as fixed effects and participant as a random effect.|||2.53|-4.76|
72497001|NCT02631538|144523647|OTHER||LS mean difference|0.71|STANDARD_ERROR_OF_MEAN|1.476|||TWO_SIDED|95.0|-2.25|3.66|||||Week 36. Analysis was performed using mixed effects repeated measures model, with Baseline, treatment, visit and interactions of visit with treatment as fixed effects and participant as a random effect.|||3.66|-2.25|
72497002|NCT02631538|144523647|OTHER||LS mean difference|-2.8|STANDARD_ERROR_OF_MEAN|1.57|||TWO_SIDED|95.0|-5.95|0.34|||||Week 52. Analysis was performed using mixed effects repeated measures model, with Baseline, treatment, visit and interactions of visit with treatment as fixed effects and participant as a random effect.|||0.34|-5.95|
72443580|NCT03069313|144400913|OTHER|||||||0.056|||||||t-test, 2 sided|||This analysis is comparing EWB before and after treatment.||||0.056
72443581|NCT03069313|144400913|OTHER||||||<|0.0001|||||||t-test, 2 sided|||This analysis is comparing PWB before and after treatment.||||<0.0001
72443582|NCT03069313|144400913|OTHER|||||||0.09|||||||t-test, 2 sided|||This analysis is comparing FWB before and after treatment.||||0.09
72443583|NCT03069313|144400913|OTHER||||||<|0.0001|||||||t-test, 2 sided|||This analysis is comparing ESS before and after treatment.||||<0.0001
72443584|NCT01872078|144400938|SUPERIORITY_OR_OTHER||Ratio (%)|87.04|||||TWO_SIDED|95.0|58.52|129.47||||||The null hypothesis is that the ratio of Active to Control in LH AUC(0-8) ratio to baseline at day 7= 100%||129.47|58.52|
72443585|NCT01872078|144400938|SUPERIORITY_OR_OTHER||Ratio (%)|78.76|||||TWO_SIDED|95.0|53.41|116.16||||||The null hypothesis is that the ratio of Active to Control in LH AUC(0-8) ratio to baseline at day 7= 100%||116.16|53.41|
72443586|NCT01872078|144400938|SUPERIORITY_OR_OTHER||Ratio (%)|47.99|||||TWO_SIDED|95.0|32.73|70.36||||||The null hypothesis is that the ratio of Active to Control in LH AUC(0-8) ratio to baseline at day 7= 100%||70.36|32.73|
72443587|NCT01424670|144400939|SUPERIORITY|||||||0.0562||||||For testing the null hypothesis, the distribution of the time to SCC within the 6-month Intensive Period were compared between the 2 treatment groups using the stratified modified Peto-Peto modification of Gehan's Wilcoxon rank sum test.|Modified Peto-Peto test|||Comparison of distributions of time to SCC using the MGIT culture system during the 6-month (26-week) Intensive Period.||||0.0562
72497003|NCT02631538|144523647|OTHER||LS mean difference|-0.91|STANDARD_ERROR_OF_MEAN|1.237|||TWO_SIDED|95.0|-3.39|1.56|||||Week 52. Analysis was performed using mixed effects repeated measures model, with Baseline, treatment, visit and interactions of visit with treatment as fixed effects and participant as a random effect.|||1.56|-3.39|
72388828|NCT01817530|144286156|SUPERIORITY||Odds Ratio (OR)|9.65|||<|0.001|TWO_SIDED|95.0|4.38|21.25||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline as a covariate.|Regression, Logistic|||||21.25|4.38|< 0.001
72388829|NCT01817530|144286156|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a chi-square test.|Chi-squared|||||||< 0.001
72388830|NCT01817530|144286156|SUPERIORITY||Odds Ratio (OR)|16.17|||<|0.001|TWO_SIDED|95.0|7.13|36.67||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline as a covariate.|Regression, Logistic|||||36.67|7.13|< 0.001
72388831|NCT01817530|144286156|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a chi-square test.|Chi-squared|||||||< 0.001
72497004|NCT02631538|144523647|OTHER||LS mean difference|-1.36|STANDARD_ERROR_OF_MEAN|1.275|||TWO_SIDED|95.0|-3.91|1.2|||||Week 52. Analysis was performed using mixed effects repeated measures model, with Baseline, treatment, visit and interactions of visit with treatment as fixed effects and participant as a random effect.|||1.20|-3.91|
72388832|NCT01817530|144286157|SUPERIORITY||Odds Ratio (OR)|123.14|||<|0.001|TWO_SIDED|95.0|25.93|584.85||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline as a covariate.|Regression, Logistic|||||584.85|25.93|< 0.001
72388833|NCT01817530|144286157|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a chi-square test.|Chi-squared|||||||< 0.001
72388834|NCT01817530|144286157|SUPERIORITY||Odds Ratio (OR)|40.56|||<|0.001|TWO_SIDED|95.0|13.59|121.03||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline as a covariate.|Regression, Logistic|||||121.03|13.59|< 0.001
72388835|NCT01817530|144286157|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a chi-square test.|Chi-squared|||||||< 0.001
72388836|NCT01817530|144286157|SUPERIORITY||Odds Ratio (OR)|19.01|||<|0.001|TWO_SIDED|95.0|7.44|48.58||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline as a covariate.|Regression, Logistic|||||48.58|7.44|< 0.001
72388837|NCT01817530|144286157|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a chi-square test.|Chi-squared|||||||< 0.001
72388838|NCT01817530|144286157|SUPERIORITY||Odds Ratio (OR)|22.77|||<|0.001|TWO_SIDED|95.0|9.29|55.77||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline as a covariate.|Regression, Logistic|||||55.77|9.29|< 0.001
72388839|NCT01817530|144286157|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a chi-square test.|Chi-squared|||||||< 0.001
72388840|NCT01817530|144286157|SUPERIORITY||Odds Ratio (OR)|10.89|||<|0.001|TWO_SIDED|95.0|4.88|24.27||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline as a covariate.|Regression, Logistic|||||24.27|4.88|< 0.001
72388841|NCT01817530|144286157|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a chi-square test.|Chi-squared|||||||< 0.001
72388842|NCT01817530|144286157|SUPERIORITY||Odds Ratio (OR)|9.72|||<|0.001|TWO_SIDED|95.0|4.46|21.22||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline as a covariate.|Regression, Logistic|||||21.22|4.46|< 0.001
72388843|NCT01817530|144286157|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a chi-square test.|Chi-squared|||||||< 0.001
72388844|NCT01817530|144286158|SUPERIORITY||Odds Ratio (OR)|24.73|||<|0.001|TWO_SIDED|95.0|8.57|71.32||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||||71.32|8.57|< 0.001
72388845|NCT01817530|144286158|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a chi-square test.|Chi-squared|||||||< 0.001
72388846|NCT01817530|144286158|SUPERIORITY||Odds Ratio (OR)|17.21|||<|0.001|TWO_SIDED|95.0|6.57|45.05||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||||45.05|6.57|< 0.001
72388847|NCT01817530|144286158|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a chi-square test.|Chi-squared|||||||< 0.001
72388848|NCT01817530|144286158|SUPERIORITY||Odds Ratio (OR)|8.69|||<|0.001|TWO_SIDED|95.0|3.79|19.92||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||||19.92|3.79|< 0.001
72388849|NCT01817530|144286158|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a chi-square test.|Chi-squared|||||||< 0.001
72388850|NCT01817530|144286158|SUPERIORITY||Odds Ratio (OR)|18.67|||<|0.001|TWO_SIDED|95.0|7.11|49.02||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||||49.02|7.11|< 0.001
72388851|NCT01817530|144286158|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a chi-square test.|Chi-squared|||||||< 0.001
72388852|NCT01817530|144286158|SUPERIORITY||Odds Ratio (OR)|4.94|||<|0.001|TWO_SIDED|95.0|2.43|10.04||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||||10.04|2.43|< 0.001
72497005|NCT02631538|144523647|OTHER||LS mean difference|-1.89|STANDARD_ERROR_OF_MEAN|1.548|||TWO_SIDED|95.0|-4.99|1.21|||||Week 52. Analysis was performed using mixed effects repeated measures model, with Baseline, treatment, visit and interactions of visit with treatment as fixed effects and participant as a random effect.|||1.21|-4.99|
72497006|NCT02631538|144523647|OTHER||LS mean difference|-0.44|STANDARD_ERROR_OF_MEAN|1.261|||TWO_SIDED|95.0|-2.97|2.08|||||Week 52. Analysis was performed using mixed effects repeated measures model, with Baseline, treatment, visit and interactions of visit with treatment as fixed effects and participant as a random effect.|||2.08|-2.97|
72497007|NCT02631538|144523647|OTHER||LS mean difference|-3.99|STANDARD_ERROR_OF_MEAN|1.699|||TWO_SIDED|95.0|-7.39|-0.58|||||Week 68. Analysis was performed using mixed effects repeated measures model, with Baseline, treatment, visit and interactions of visit with treatment as fixed effects and participant as a random effect.|||-0.58|-7.39|
72497008|NCT02631538|144523647|OTHER||LS mean difference|-1.87|STANDARD_ERROR_OF_MEAN|1.336|||TWO_SIDED|95.0|-4.54|0.81|||||Week 68. Analysis was performed using mixed effects repeated measures model, with Baseline, treatment, visit and interactions of visit with treatment as fixed effects and participant as a random effect.|||0.81|-4.54|
72388853|NCT01817530|144286158|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a chi-square test.|Chi-squared|||||||< 0.001
72497009|NCT02631538|144523647|OTHER||LS mean difference|-1.35|STANDARD_ERROR_OF_MEAN|1.379|||TWO_SIDED|95.0|-4.12|1.41|||||Week 68. Analysis was performed using mixed effects repeated measures model, with Baseline, treatment, visit and interactions of visit with treatment as fixed effects and participant as a random effect.|||1.41|-4.12|
72497010|NCT02631538|144523647|OTHER||LS mean difference|-2.12|STANDARD_ERROR_OF_MEAN|1.674|||TWO_SIDED|95.0|-5.47|1.23|||||Week 68. Analysis was performed using mixed effects repeated measures model, with Baseline, treatment, visit and interactions of visit with treatment as fixed effects and participant as a random effect.|||1.23|-5.47|
72388854|NCT01817530|144286158|SUPERIORITY||Odds Ratio (OR)|11.76|||<|0.001|TWO_SIDED|95.0|5.17|26.79|||Regression, Logistic|P value is from a logistic regression model including treatment as the main effect and baseline value as a covariate.||||26.79|5.17|< 0.001
72388855|NCT01817530|144286158|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a chi-square test.|Chi-squared|||||||< 0.001
72388856|NCT01817530|144286159|SUPERIORITY||Odds Ratio (OR)|31.48|||<|0.001|TWO_SIDED|95.0|10.02|98.83||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||||98.83|10.02|< 0.001
72388857|NCT01817530|144286159|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a chi-square test.|Chi-squared|||||||< 0.001
72388858|NCT01817530|144286159|SUPERIORITY||Odds Ratio (OR)|14.39|||<|0.001|TWO_SIDED|95.0|5.77|35.91||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||||35.91|5.77|< 0.001
72388859|NCT01817530|144286159|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a chi-square test.|Chi-squared|||||||< 0.001
72388860|NCT01817530|144286159|SUPERIORITY||Odds Ratio (OR)|9.82|||<|0.001|TWO_SIDED|95.0|4.23|22.8||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||||22.8|4.23|< 0.001
72388861|NCT01817530|144286159|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a chi-square test.|Chi-squared|||||||< 0.001
72388862|NCT01817530|144286159|SUPERIORITY||Odds Ratio (OR)|16.58|||<|0.001|TWO_SIDED|95.0|6.66|41.26||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||||41.26|6.66|< 0.001
72388863|NCT01817530|144286159|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a chi-square test.|Chi-squared|||||||< 0.001
72388864|NCT01817530|144286159|SUPERIORITY||Odds Ratio (OR)|7.02|||<|0.001|TWO_SIDED|95.0|3.36|14.68||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||||14.68|3.36|< 0.001
72388865|NCT01817530|144286159|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a chi-square test.|Chi-squared|||||||< 0.001
72388866|NCT01817530|144286159|SUPERIORITY||Odds Ratio (OR)|10.73|||<|0.001|TWO_SIDED|95.0|4.85|23.76||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||||23.76|4.85|< 0.001
72497011|NCT02631538|144523647|OTHER||LS mean difference|0.51|STANDARD_ERROR_OF_MEAN|1.362|||TWO_SIDED|95.0|-2.21|3.24|||||Week 68. Analysis was performed using mixed effects repeated measures model, with Baseline, treatment, visit and interactions of visit with treatment as fixed effects and participant as a random effect.|||3.24|-2.21|
72497012|NCT00964431|144523652|SUPERIORITY_OR_OTHER||Mean Difference (Net)|9.545|STANDARD_ERROR_OF_MEAN|1.8912|<|0.001|TWO_SIDED|95.0|5.816|13.275|||ANCOVA|||||13.275|5.816|<0.001
72497013|NCT01482910|144523653|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.1|||<|0.0001|TWO_SIDED|95.0|6.8|13.4||Hierarchical testing procedure was used in the order of pre-defined fixed sequence (primary endpoint first, then confirmatory secondary efficacy point next). A two-sided significance level of 0.05 was used.|ANCOVA|ANCOVA with baseline BCVA as a covariate, and treatment group and baseline BCVA group (\<45 letters vs ≥45 letters) as fixed factors|Least square mean difference (EYLEA-PDT) was estimated from ANCOVA, where a positive value is in favor of EYLEA.|Null hypothesis: mean changes are identical in both groups. A sample size of 300 subjects with a 3:1 (EYLEA to PDT) randomization ratio is sufficient to detect the superiority of EYLEA to PDT assuming a two-sided alpha level of 0.05, a power of 90%, a treatment difference of 7.5 letters and a common standard deviation of 14 letters.||13.4|6.8|<0.0001
72504771|NCT03114969|144540506|SUPERIORITY||Odds Ratio (OR)|3.84|||<|0.001|TWO_SIDED|95.0|2.135|6.905||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta+\[Relvar Ellipta+LAMA\] as comparator.|||6.905|2.135|<0.001
72388867|NCT01817530|144286159|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a chi-square test.|Chi-squared|||||||< 0.001
72388868|NCT01817530|144286160|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||< 0.001
72388869|NCT01817530|144286160|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||< 0.001
72388870|NCT01817530|144286160|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||< 0.001
72388871|NCT01817530|144286160|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||< 0.001
72388872|NCT01817530|144286160|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||< 0.001
72388873|NCT01817530|144286160|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||< 0.001
72388874|NCT01817530|144286161|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||< 0.001
72388875|NCT01817530|144286161|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||< 0.001
72388876|NCT01817530|144286161|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||< 0.001
72388877|NCT01817530|144286161|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||< 0.001
72388878|NCT01817530|144286161|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||< 0.001
72388879|NCT01817530|144286161|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||< 0.001
72388880|NCT01817530|144286162|SUPERIORITY||difference in LS mean change|-3.7|STANDARD_ERROR_OF_MEAN|1.32||0.007|TWO_SIDED|95.0|-6.28|-1.03||P value for test of difference between each elagolix dose group and placebo at each postbaseline time point is from an ANCOVA model with treatment as the main effect and baseline value as a covariate.|ANCOVA|||||-1.03|-6.28|0.007
72388881|NCT01817530|144286162|SUPERIORITY||difference in LS mean change|-1.5|STANDARD_ERROR_OF_MEAN|0.98||0.132|TWO_SIDED|95.0|-3.44|0.46||P value for test of difference between each elagolix dose group and placebo at each postbaseline time point is from an ANCOVA model with treatment as the main effect and baseline value as a covariate.|ANCOVA|||||0.46|-3.44|0.132
72388882|NCT01817530|144286162|SUPERIORITY||difference in LS mean change|0.1|STANDARD_ERROR_OF_MEAN|0.94||0.876|TWO_SIDED|95.0|-1.71|2.0||P value for test of difference between each elagolix dose group and placebo at each postbaseline time point is from an ANCOVA model with treatment as the main effect and baseline value as a covariate.|ANCOVA|||||2.00|-1.71|0.876
72388883|NCT01817530|144286162|SUPERIORITY||difference in LS mean change|-1.9|STANDARD_ERROR_OF_MEAN|1.0||0.055|TWO_SIDED|95.0|-3.92|0.04||P value for test of difference between each elagolix dose group and placebo at each postbaseline time point is from an ANCOVA model with treatment as the main effect and baseline value as a covariate.|ANCOVA|||||0.04|-3.92|0.055
72388884|NCT01817530|144286162|SUPERIORITY||difference in LS mean change|0.1|STANDARD_ERROR_OF_MEAN|0.82||0.898|TWO_SIDED|95.0|-1.52|1.74||P value for test of difference between each elagolix dose group and placebo at each postbaseline time point is from an ANCOVA model with treatment as the main effect and baseline value as a covariate.|ANCOVA|||||1.74|-1.52|0.898
72388885|NCT01817530|144286162|SUPERIORITY||difference in LS mean change|-0.4|STANDARD_ERROR_OF_MEAN|0.81||0.59|TWO_SIDED|95.0|-2.05|1.17||P value for test of difference between each elagolix dose group and placebo at each postbaseline time point is from an ANCOVA model with treatment as the main effect and baseline value as a covariate.|ANCOVA|||||1.17|-2.05|0.59
72388886|NCT01817530|144286163|SUPERIORITY||difference in LS mean change|-1.0|STANDARD_ERROR_OF_MEAN|0.31||0.001|TWO_SIDED|95.0|-1.64|-0.42||P value for test of difference between each elagolix dose group and placebo at each postbaseline time point is from an ANCOVA model with treatment as the main effect and baseline value as a covariate.|ANCOVA|||||-0.42|-1.64|0.001
72504772|NCT03114969|144540506|SUPERIORITY||Odds Ratio (OR)|3.231|||<|0.001|TWO_SIDED|95.0|1.81|5.766||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta+\[Relvar Ellipta+LAMA\] as comparator.|||5.766|1.810|<0.001
72504773|NCT03114969|144540507|SUPERIORITY||Odds Ratio (OR)|1.931||||0.12|TWO_SIDED|95.0|0.842|4.428||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator.|||4.428|0.842|0.120
72504774|NCT03114969|144540507|SUPERIORITY||Odds Ratio (OR)|1.636||||0.232|TWO_SIDED|95.0|0.73|3.664||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator.|||3.664|0.730|0.232
72504775|NCT03114969|144540508|SUPERIORITY||Odds Ratio (OR)|4.217|||<|0.001|TWO_SIDED|95.0|2.019|8.807||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator.|||8.807|2.019|<0.001
72504776|NCT03114969|144540508|SUPERIORITY||Odds Ratio (OR)|5.41|||<|0.001|TWO_SIDED|95.0|2.66|11.005||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator.|||11.005|2.660|<0.001
72504777|NCT03114969|144540509|SUPERIORITY||Odds Ratio (OR)|2.477||||0.007|TWO_SIDED|95.0|1.274|4.815||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta+\[Relvar Ellipta+LAMA\] as comparator.|||4.815|1.274|0.007
72504778|NCT03114969|144540509|SUPERIORITY||Odds Ratio (OR)|2.748||||0.006|TWO_SIDED|95.0|1.328|5.683||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta+\[Relvar Ellipta+LAMA\] as comparator.|||5.683|1.328|0.006
72443588|NCT01424670|144400940|SUPERIORITY|For testing the homogeneity of proportions, 2 samples were compared using the stratified Cochran-Mantel-Haenszel test.|Ratio of Probability|1.096||||0.3818|TWO_SIDED|95.0|0.889|1.352|||Cochran-Mantel-Haenszel||The stratified Cochran-Mantel-Haenszel test statistics were used for estimation.|Statistical comparison of proportion of participants with SCC at 2 months.||1.352|0.889|0.3818
72443589|NCT01424670|144400940|SUPERIORITY|For testing the homogeneity of proportions, 2 samples were compared using the stratified Cochran-Mantel-Haenszel test.|Ratio of Probability|1.017||||0.7131|TWO_SIDED|95.0|0.927|1.115|||Cochran-Mantel-Haenszel||The stratified Cochran-Mantel-Haenszel test statistics were used for estimation.|Statistical comparison of proportion of participants with SCC at 6 months.||1.115|0.927|0.7131
72443590|NCT01424670|144400941|SUPERIORITY||Relative Ratio of Probability|0.969||||0.5945|TWO_SIDED|95.0|0.866|1.084|||Cochran-Mantel-Haenszel|||Statistical comparison of proportion with sustained SCC at Month 18.||1.084|0.866|0.5945
72443591|NCT01424670|144400941|SUPERIORITY||Relative Ratio of Probability|0.97||||0.6164|TWO_SIDED|95.0|0.864|1.089|||Cochran-Mantel-Haenszel|||Statistical comparison of proportion with sustained SCC at Month 24.||1.089|0.864|0.6164
72443592|NCT01424670|144400941|SUPERIORITY||Relative Ratio of Probability|0.991||||0.8951|TWO_SIDED|95.0|0.872|1.127|||Cochran-Mantel-Haenszel|||Statistical comparison of proportion with sustained SCC at Month 30.||1.127|0.872|0.8951
72443593|NCT01424670|144400942|SUPERIORITY||Relative Ratio of Probability|0.965||||0.5269|TWO_SIDED|95.0|0.869|1.073|||Cochran-Mantel-Haenszel|||Statistical comparison of proportions with favorable treatment outcomes assessed by the Principal Investigator.||1.073|0.869|0.5269
72443594|NCT01424670|144400944|SUPERIORITY||Mean Difference (Final Values)|-0.3||||0.6986|TWO_SIDED|95.0|-1.9|1.3|||ANCOVA|||Statistical comparison of mean AUC of change from Baseline.||1.3|-1.9|0.6986
72443595|NCT01424670|144400945|SUPERIORITY|||||||0.6825|||||||ANCOVA|||Statistical analysis for Week 1.||||0.6825
72443596|NCT01424670|144400945|SUPERIORITY|||||||0.807|||||||ANCOVA|||Statistical analysis for Week 2.||||0.807
72443597|NCT01424670|144400945|SUPERIORITY|||||||0.269|||||||ANCOVA|||Statistical analysis for Week 3.||||0.269
72443598|NCT01424670|144400945|SUPERIORITY|||||||0.2333|||||||ANCOVA|||Statistical analysis for Week 24.||||0.2333
72443599|NCT01424670|144400945|SUPERIORITY|||||||0.9397|||||||ANCOVA|||Statistical analysis for Month 6.||||0.9397
72443600|NCT01424670|144400946|SUPERIORITY||Relative Ratio of Probability|0.991||||0.8951|TWO_SIDED|95.0|0.872|1.127|||Cochran-Mantel-Haenszel|||Statistical comparison of proportion with treatment success at Month 30.||1.127|0.872|0.8951
72443601|NCT02891915|144400969|SUPERIORITY|DOOR is a composite endpoint created using clinical outcomes from the first 5 days and at Outcome Assessment Visit #1 (OAV #1). It is based on adequate clinical response at OAV #1, solicited symptoms from first 5 days and number of days of antibiotics use for worsening pneumonia from the first 5 days of the study.|Pr (Higher DOOR in Short-Course)|0.69|||<|0.001|TWO_SIDED|95.0|0.63|0.75||Missing DOOR values at OAV #1 were first imputed using linear regression using baseline covariates and available DOOR components as covariates.|Wilcoxon (Mann-Whitney)|The Mann-Whitney test was run on the multiple imputed datasets to generate estimates of DOOR probability and p-value||Null: the sum of the probability that a subject assigned to the 5-day arm will have a higher DOOR (higher DOOR is a lower value and is superior) than if assigned to the 10-day arm plus one-half the probability of equal DOORs is 50% (i.e., no difference in DOOR).||0.75|0.63|<0.001
72443602|NCT02891915|144400970|SUPERIORITY|Testing whether Short course is superior to Standard course based on DOOR at OAV #2|Pr (Higher DOOR in Short-Course)|0.63|||<|0.001|TWO_SIDED|95.0|0.57|0.69||Missing DOOR values at OAV #2 were first imputed using linear regression using baseline covariates and available DOOR components as covariates|Wilcoxon (Mann-Whitney)|The Mann-Whitney test was run on the multiple imputed datasets to generate estimates of DOOR probability and p-value.||Null: the sum of the probability that a subject assigned to the 5-day arm will have a higher DOOR (higher DOOR is a lower numerical value and is superior) than if assigned to the 10-day arm plus one-half the probability of equal DOORs is 50% (i.e., no difference in DOOR).||0.69|0.57|<0.001
72443603|NCT01091168|144400981|SUPERIORITY||Hazard Ratio (HR)|1.04||||0.673|TWO_SIDED|95.0|0.86|1.25|||Cochran-Mantel-Haenszel|||Kaplan-Meier curves and life tables by treatment arm were provided. Confidence intervals on the median were calculated using the Brookmeyer and Crowley method. Hazard ratio and 95% confidence intervals were reported. A stratified Cox proportional model was performed to compare the two treatment arms taking into account the stratification factors (except centre) used at the time of randomisation.||1.25|0.86|0.673
72443604|NCT01091168|144400982|SUPERIORITY|||||||0.0424|||||||Log Rank|||The disease control rate (DCR) were compared in the ITT population and in the population evaluable for response between the 2 arms with a cochran Mantel Haenszel, stratified on WHO performance status at baseline, number of prior chemotherapy lines for the treatment of disease and disease measurability at Baseline.||||0.0424
72443605|NCT01091168|144400983|SUPERIORITY||Hazard Ratio (HR)|0.94||||0.4927|TWO_SIDED|95.0|0.8|1.12|||Log Rank|||PFS was compared between the 2 treatment arms by the log-rank test procedure with the 5 % significant level, stratified on the stratification factors (except study site) as specified at the time of randomisation. Os was analysed using Kaplan-Meir method and summarized with median and 95% CI of the median||1.12|0.8|0.4927
72443606|NCT04924062|144400988|OTHER||Hazard Ratio (HR)|0.74|||||TWO_SIDED|95.0|0.51|1.08|||||HR=Arm A/Arm B|||1.08|0.51|
72443607|NCT04924062|144400989|OTHER||Hazard Ratio (HR)|0.83|||||TWO_SIDED|95.0|0.58|1.19|||||HR=Arm A/Arm B|||1.19|0.58|
72443608|NCT04924062|144400990|OTHER||Difference in Percentages|7.1|||||TWO_SIDED|95.0|-7.5|21.6|||||Difference=Arm A minus Arm B|||21.6|-7.5|
72443609|NCT04337372|144401003|SUPERIORITY||||||=|0.002||||||F(2, 58) = 7.19|MANOVA|||To examine the impact of infant age and label condition on the proportion of infant's attention to the book, a 3 (infant age: 6, 9, or 12 months) x 3 (label condition: individual, categorical, or no label) MANOVA was run. Age was measured between subjects, label condition was within subjects, and infant's proportion of attention to the book was the dependent variable. The main effect of age is reported here.||||=.002
72497014|NCT01482910|144523654|SUPERIORITY_OR_OTHER||Risk Difference (RD)|6.6||||0.0359|TWO_SIDED|95.0|0.4|12.9||Hierarchical testing procedure was used in the order of pre-defined fixed sequence (primary endpoint first, then confirmatory secondary efficacy point next). A two-sided significance level of 0.05 was used.|Cochran-Mantel-Haenszel|CMH adjusted for baseline BCVA group (\<45 letters vs ≥45 letters)|Proportion difference (EYLEA-PDT) was estimated from CMH, where a positive value is in favor of EYLEA.|Null hypothesis: proportions are identical in both groups||12.9|0.4|0.0359
72560088|NCT00660387|144650679|SUPERIORITY_OR_OTHER||Treatment Difference (LS Mean)|-3.0|STANDARD_ERROR_OF_MEAN|1.1||0.0086|TWO_SIDED|95.0|-5.3|-0.8|||ANCOVA|Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding baseline as a covariate.||Since the null hypothesis for the primary analysis was rejected in favor of the alternative hypothesis, hierarchical testing was performed for secondary variables on the Full Analysis data set at the 0.50 level using a gatekeeping procedure to preserve family-wise error rate.||-0.8|-5.3|0.0086
72560089|NCT00660387|144650680|SUPERIORITY_OR_OTHER||Treatment Difference (LS Mean)|1.4|STANDARD_ERROR_OF_MEAN|2.1||0.502|TWO_SIDED|95.0|-2.8|5.6|||ANCOVA|Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding baseline as a covariate.||Since the null hypothesis for the primary analysis was rejected in favor of the alternative hypothesis, hierarchical testing was performed for secondary variables on the Full Analysis data set at the 0.50 level using a gatekeeping procedure to preserve family-wise error rate.||5.6|-2.8|0.5020
72560090|NCT00660387|144650681|SUPERIORITY_OR_OTHER||Treatment Difference (LS Mean)|0.07|STANDARD_ERROR_OF_MEAN|0.038||0.067|TWO_SIDED|95.0|-0.005|0.146|||ANCOVA|Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding Baseline as a covariate.||Since the null hypothesis for the primary analysis was rejected in favor of the alternative hypothesis, hierarchical testing was performed for secondary variables on the Full Analysis data set at the 0.50 level using a gatekeeping procedure to preserve family-wise error rate.||0.146|-0.005|0.0670
72560091|NCT00660387|144650682|SUPERIORITY_OR_OTHER||Treatment Difference (LS Mean)|-4.5|STANDARD_ERROR_OF_MEAN|3.1||0.1501|TWO_SIDED|95.0|-10.7|1.7|||ANCOVA|Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding baseline as a covariate.||Since the null hypothesis for the primary analysis was rejected in favor of the alternative hypothesis, hierarchical testing was performed for secondary variables on the Full Analysis data set at the 0.50 level using a gatekeeping procedure to preserve family-wise error rate.||1.7|-10.7|0.1501
72560092|NCT00660387|144650683|SUPERIORITY_OR_OTHER||Treatment Difference (LS Mean)|-0.08|STANDARD_ERROR_OF_MEAN|0.45||0.8574|TWO_SIDED|95.0|-0.98|0.82|||ANCOVA|Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding baseline as a covariate.||||0.82|-0.98|0.8574
72560093|NCT00660387|144650684|SUPERIORITY_OR_OTHER||Treatment Difference (LS Mean)|-10.4|STANDARD_ERROR_OF_MEAN|4.3||0.0184|TWO_SIDED|95.0|-19.1|-1.8|||ANCOVA|Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding baseline as a covariate.||||-1.8|-19.1|0.0184
72560094|NCT00660387|144650685|SUPERIORITY_OR_OTHER||Treatment Difference (LS Mean)|-11.6|STANDARD_ERROR_OF_MEAN|4.5||0.0129|TWO_SIDED|95.0|-20.6|-2.5|||ANCOVA|Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding baseline as a covariate.||||-2.5|-20.6|0.0129
72388887|NCT01817530|144286163|SUPERIORITY||difference in LS mean change|-1.0|STANDARD_ERROR_OF_MEAN|0.23|<|0.001|TWO_SIDED|95.0|-1.42|-0.48||P value for test of difference between each elagolix dose group and placebo at each postbaseline time point is from an ANCOVA model with treatment as the main effect and baseline value as a covariate.|ANCOVA|||||-0.48|-1.42|< 0.001
72388888|NCT01817530|144286163|SUPERIORITY||difference in LS mean change|-0.7|STANDARD_ERROR_OF_MEAN|0.22||0.002|TWO_SIDED|95.0|-1.12|-0.25||P value for test of difference between each elagolix dose group and placebo at each postbaseline time point is from an ANCOVA model with treatment as the main effect and baseline value as a covariate.|ANCOVA|||||-0.25|-1.12|0.002
72388889|NCT01817530|144286163|SUPERIORITY||difference in LS mean change|-0.5|STANDARD_ERROR_OF_MEAN|0.29||0.118|TWO_SIDED|95.0|-1.04|0.12||P value for test of difference between each elagolix dose group and placebo at each postbaseline time point is from an ANCOVA model with treatment as the main effect and baseline value as a covariate.|ANCOVA|||||0.12|-1.04|0.118
72388890|NCT01817530|144286163|SUPERIORITY||difference in LS mean change|-0.7|STANDARD_ERROR_OF_MEAN|0.24||0.004|TWO_SIDED|95.0|-1.16|-0.22||P value for test of difference between each elagolix dose group and placebo at each postbaseline time point is from an ANCOVA model with treatment as the main effect and baseline value as a covariate.|ANCOVA|||||-0.22|-1.16|0.004
72388891|NCT01817530|144286163|SUPERIORITY||difference in LS mean change|-1.0|STANDARD_ERROR_OF_MEAN|0.23|<|0.001|TWO_SIDED|95.0|-1.51|-0.59||P value for test of difference between each elagolix dose group and placebo at each postbaseline time point is from an ANCOVA model with treatment as the main effect and baseline value as a covariate.|ANCOVA|||||-0.59|-1.51|< 0.001
72388892|NCT01817530|144286164|SUPERIORITY||difference in LS mean change|-0.5|STANDARD_ERROR_OF_MEAN|0.16||0.004|TWO_SIDED|95.0|-0.79|-0.15||P value for test of difference between each elagolix dose group and placebo at each post-baseline time point is from an ANCOVA model with treatment as the main effect and baseline as a covariate.|ANCOVA|||||-0.15|-0.79|0.004
72388893|NCT01817530|144286164|SUPERIORITY||difference in LS mean change|-0.1|STANDARD_ERROR_OF_MEAN|0.13||0.314|TWO_SIDED|95.0|-0.4|0.13||P value for test of difference between each elagolix dose group and placebo at each post-baseline time point is from an ANCOVA model with treatment as the main effect and baseline as a covariate.|ANCOVA|||||0.13|-0.4|0.314
72388894|NCT01817530|144286164|SUPERIORITY||difference in LS mean change|0.1|STANDARD_ERROR_OF_MEAN|0.13||0.307|TWO_SIDED|95.0|-0.12|0.39||P value for test of difference between each elagolix dose group and placebo at each post-baseline time point is from an ANCOVA model with treatment as the main effect and baseline as a covariate.|ANCOVA|||||0.39|-0.12|0.307
72497015|NCT01872338|144523661|SUPERIORITY||Incident Rate Ratio|0.5||||0.015|TWO_SIDED|95.0|0.29|0.87|||negative binomial regression|||||.87|.29|.015
72560095|NCT00660387|144650686|SUPERIORITY_OR_OTHER||Treatment Difference (LS Mean)|-2.2|STANDARD_ERROR_OF_MEAN|3.4||0.5246|TWO_SIDED|95.0|-9.0|4.6|||ANCOVA|Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding baseline as a covariate.||||4.6|-9.0|0.5246
72388895|NCT01817530|144286164|SUPERIORITY||difference in LS mean change|-0.3|STANDARD_ERROR_OF_MEAN|0.16||0.106|TWO_SIDED|95.0|-0.58|0.06||P value for test of difference between each elagolix dose group and placebo at each post-baseline time point is from an ANCOVA model with treatment as the main effect and baseline as a covariate.|ANCOVA|||||0.06|-0.58|0.106
72388896|NCT01817530|144286164|SUPERIORITY||difference in LS mean change|-0.1|STANDARD_ERROR_OF_MEAN|0.13||0.424|TWO_SIDED|95.0|-0.36|0.15||P value for test of difference between each elagolix dose group and placebo at each post-baseline time point is from an ANCOVA model with treatment as the main effect and baseline as a covariate.|ANCOVA|||||0.15|-0.36|0.424
72443610|NCT04337372|144401003|SUPERIORITY||||||=|0.09||||||F(1.78, 103.37) = 2.48|MANOVA|||To examine the impact of infant age and label condition on the proportion of infant's attention to the book, a 3 (infant age: 6, 9, or 12 months) x 3 (label condition: individual, categorical, or no label) MANOVA was run. Age was measured between subjects, label condition was within subjects, and infant's proportion of attention to the book was the dependent variable. The main effect of condition is reported here.||||=.09
72443611|NCT04337372|144401003|SUPERIORITY||||||<|0.05||||||F(3.56, 103.37) = 2.55|MANOVA|||To examine the impact of infant age and label condition on the proportion of infant's attention to the book, a 3 (infant age: 6, 9, or 12 months) x 3 (label condition: individual, categorical, or no label) MANOVA was run. Age was measured between subjects, label condition was within subjects, and infant's proportion of attention to the book was the dependent variable. The interaction between age and condition is reported here.||||<.05
72443612|NCT04337372|144401004|SUPERIORITY||||||=|0.557||||||F(2,47) = .592|MANOVA|||EEG power, as measured by the signal-to-noise ratio (SNR) was modulated by label condition across age, data were extracted from a mid-occipital cluster of Oz and its 6 nearest neighbors (channels 70, 71, 74, 75, 76, 82, 83) for each of the conditions. SNR data were then submitted to a two-factor MANOVA with Label (Individual, Category, Control/No Label) as a within-subjects factor and Age (6 months, 9 months, 12 months) as a between-subjects factor. The main effect of age is reported here.||||=.557
72443613|NCT04337372|144401004|SUPERIORITY||||||=|0.47||||||F(2,47) = .767|MANOVA|||EEG power, as measured by the signal-to-noise ratio (SNR) was modulated by label condition across age, data were extracted from a mid-occipital cluster of Oz and its 6 nearest neighbors (channels 70, 71, 74, 75, 76, 82, 83) for each of the conditions. SNR data were then submitted to a two-factor MANOVA with Label (Individual, Category, Control/No Label) as a within-subjects factor and Age (6 months, 9 months, 12 months) as a between-subjects factor. The main effect of condition is reported here.||||=.470
72443614|NCT04337372|144401004|SUPERIORITY||||||=|0.046||||||F(4,94) = 2.524|MANOVA|||EEG power, as measured by signal-to-noise ratio (SNR) was modulated by label condition across age, data were extracted from a mid-occipital cluster of Oz and its 6 nearest neighbors (channels 70, 71, 74, 75, 76, 82, 83) for each condition. SNR data were then submitted to a two-factor MANOVA with Label (Individual, Category, Control/No Label) as a within-subjects factor and Age (6 months, 9 months, 12 months) as a between-subjects factor. The interaction of age and condition is reported here.||||=.046
72443615|NCT04337372|144401005|SUPERIORITY||||||=|0.664||||||F(2,45) = .413|MANOVA|||EEG Data were extracted from a mid-occipital cluster for each conditions for parents \& infants. Data were entered into a 2-factor MANOVA with Label (Individual, Category, No Label) as a within-subjects factor and Age (6 mo, 9 mo, 12 mo) as a between-subjects factor. The phase-locking index measures the extent to which the parent \& infant oscillatory response is in the same phase across time (bounded between 0 and 1, 1 being perfect synchrony. The main effect of age is reported here.||||=.664
72443616|NCT04337372|144401005|SUPERIORITY||||||=|0.768||||||F(2,45) = .266|MANOVA|||EEG Data were extracted from a mid-occipital cluster for each conditions for parents \& infants. Data were entered into a 2-factor MANOVA with Label (Individual, Category, No Label) as a within-subjects factor and Age (6 mo, 9 mo, 12 mo) as a between-subjects factor. The phase-locking index measures the extent to which the parent \& infant oscillatory response is in the same phase across time (bounded between 0 and 1, 1 being perfect synchrony. The main effect of condition is reported here.||||=.768
72443617|NCT04337372|144401005|SUPERIORITY||||||=|0.2||||||F(4,90) = 1.531|MANOVA|||EEG Data were extracted from a mid-occipital cluster for each conditions for parents \& infants. Data were entered into a 2-factor MANOVA with Label (Individual, Category, No Label) as a within-subjects factor and Age (6 mo, 9 mo, 12 mo) as a between-subjects factor. The phase-locking index measures the extent to which the parent \& infant oscillatory response is in the same phase across time (bounded between 0 and 1, 1 being perfect synchrony. The interaction of age and condition is reported.||||=.200
72443618|NCT04337372|144401006|SUPERIORITY||||||=|0.022||||||F(2, 57) = 4.11|MANOVA|||To examine the impact of infant age and label condition on the proportion of joint attention to the book, a 3 (infant age: 6, 9, or 12 months) x 3 (label condition: individual, categorical, or no label) MANOVA was run. Age was measured between subjects, label condition was within subjects, and the proportion of joint attention to the book was the dependent variable. The main effect of age is reported here.||||=.022
72443619|NCT04337372|144401006|SUPERIORITY||||||=|0.004||||||F(2, 114) = 5.69|MANOVA|||To examine the impact of infant age and label condition on the proportion of joint attention to the book, a 3 (infant age: 6, 9, or 12 months) x 3 (label condition: individual, categorical, or no label) MANOVA was run. Age was measured between subjects, label condition was within subjects, and the proportion of joint attention to the book was the dependent variable. The main effect of condition is reported here.||||=.004
72443620|NCT04337372|144401006|SUPERIORITY||||||=|0.168||||||F(4, 114) = 1.64|MANOVA|||To examine the impact of infant age and label condition on the proportion of joint attention to the book, a 3 (infant age: 6, 9, or 12 months) x 3 (label condition: individual, categorical, or no label) MANOVA was run. Age was measured between subjects, label condition was within subjects, and the proportion of joint attention to the book was the dependent variable. The interaction of age and condition is reported here.||||=.168
72497016|NCT01872338|144523662|SUPERIORITY||Incident Rate Ratio|0.43||||0.01|TWO_SIDED|95.0|0.22|0.82|||negative binomial regression|||||.82|.22|.01
72388897|NCT01817530|144286164|SUPERIORITY||difference in LS mean change|0.1|STANDARD_ERROR_OF_MEAN|0.13||0.528|TWO_SIDED|95.0|-0.18|0.35||P value for test of difference between each elagolix dose group and placebo at each post-baseline time point is from an ANCOVA model with treatment as the main effect and baseline as a covariate.|ANCOVA|||||0.35|-0.18|0.528
72388898|NCT01817530|144286165|SUPERIORITY||difference in LS means|1.3|STANDARD_ERROR_OF_MEAN|0.24|<|0.001|TWO_SIDED|95.0|0.8|1.74||P value for test of difference between each elagolix dose group and placebo at each postbaseline time point is from an ANCOVA model with treatment as the main effect and baseline value as a covariate.|ANCOVA|||||1.74|0.80|< 0.001
72497017|NCT01872338|144523663|SUPERIORITY|||||||0.34|||||||Regression, Linear|repeated measures, overall time by condition effect||||||.34
72560096|NCT00660387|144650687|SUPERIORITY_OR_OTHER||Treatment Difference (LS Mean)|-4.5|STANDARD_ERROR_OF_MEAN|3.8||0.2423|TWO_SIDED|95.0|-12.0|3.1|||ANCOVA|Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding baseline as a covariate.||||3.1|-12.0|0.2423
72388899|NCT01817530|144286165|SUPERIORITY||difference in LS means|1.3|STANDARD_ERROR_OF_MEAN|0.24|<|0.001|TWO_SIDED|95.0|0.78|1.72||P value for test of difference between each elagolix dose group and placebo at each postbaseline time point is from an ANCOVA model with treatment as the main effect and baseline value as a covariate.|ANCOVA|||||1.72|0.78|< 0.001
72388900|NCT01817530|144286165|SUPERIORITY||difference in LS means|0.8|STANDARD_ERROR_OF_MEAN|0.24|<|0.001|TWO_SIDED|95.0|0.33|1.27||P value for test of difference between each elagolix dose group and placebo at each postbaseline time point is from an ANCOVA model with treatment as the main effect and baseline value as a covariate.|ANCOVA|||||1.27|0.33|< 0.001
72388901|NCT01817530|144286165|SUPERIORITY||difference in LS means|1.1|STANDARD_ERROR_OF_MEAN|0.22|<|0.001|TWO_SIDED|95.0|0.65|1.52||P value for test of difference between each elagolix dose group and placebo at each postbaseline time point is from an ANCOVA model with treatment as the main effect and baseline value as a covariate.|ANCOVA|||||1.52|0.65|< 0.001
72388902|NCT01817530|144286165|SUPERIORITY||difference in LS means|0.7|STANDARD_ERROR_OF_MEAN|0.22|<|0.001|TWO_SIDED|95.0|0.29|1.16||P value for test of difference between each elagolix dose group and placebo at each postbaseline time point is from an ANCOVA model with treatment as the main effect and baseline value as a covariate.|ANCOVA|||||1.16|0.29|< 0.001
72388903|NCT01817530|144286165|SUPERIORITY||difference in LS means|0.8|STANDARD_ERROR_OF_MEAN|0.22|<|0.001|TWO_SIDED|95.0|0.4|1.26||P value for test of difference between each elagolix dose group and placebo at each postbaseline time point is from an ANCOVA model with treatment as the main effect and baseline value as a covariate.|ANCOVA|||||1.26|0.4|< 0.001
72388904|NCT01817530|144286166|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.|Kruskal-Wallis|||Month 3||||< 0.001
72388905|NCT01817530|144286166|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.|Kruskal-Wallis|||Month 3||||< 0.001
72388906|NCT01817530|144286166|SUPERIORITY|||||||0.018||||||P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.|Kruskal-Wallis|||Month 3||||0.018
72388907|NCT01817530|144286166|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.|Kruskal-Wallis|||Month 3||||< 0.001
72388908|NCT01817530|144286166|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.|Kruskal-Wallis|||Month 3||||< 0.001
72388909|NCT01817530|144286166|SUPERIORITY|||||||0.021||||||P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.|Kruskal-Wallis|||Month 3||||0.021
72388910|NCT01817530|144286166|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.|Kruskal-Wallis|||Month 6||||< 0.001
72388911|NCT01817530|144286166|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.|Kruskal-Wallis|||Month 6||||< 0.001
72388912|NCT01817530|144286166|SUPERIORITY|||||||0.032||||||P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.|Kruskal-Wallis|||Month 6||||0.032
72560097|NCT00660387|144650688|SUPERIORITY_OR_OTHER||Treatment Difference (LS Mean)|-3.8|STANDARD_ERROR_OF_MEAN|3.1||0.2243|TWO_SIDED|95.0|-9.9|2.4|||ANCOVA|Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding baseline as a covariate.||||2.4|-9.9|0.2243
72560098|NCT00660387|144650689|SUPERIORITY_OR_OTHER||Treatment Difference (LS Mean)|-4.0|STANDARD_ERROR_OF_MEAN|3.4||0.2407|TWO_SIDED|95.0|-10.8|2.8|||ANCOVA|Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding baseline as a covariate.||||2.8|-10.8|0.2407
72388913|NCT01817530|144286166|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.|Kruskal-Wallis|||Month 6||||< 0.001
72388914|NCT01817530|144286166|SUPERIORITY|||||||0.007||||||P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.|Kruskal-Wallis|||Month 6||||0.007
72388915|NCT01817530|144286166|SUPERIORITY|||||||0.495||||||P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.|Kruskal-Wallis|||Month 6||||0.495
72388916|NCT01817530|144286166|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.|Kruskal-Wallis|||Final Visit||||< 0.001
72388917|NCT01817530|144286166|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.|Kruskal-Wallis|||Final Visit||||< 0.001
72388918|NCT01817530|144286166|SUPERIORITY|||||||0.015||||||P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.|Kruskal-Wallis|||Final Visit||||0.015
72388919|NCT01817530|144286166|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.|Kruskal-Wallis|||Final Visit||||< 0.001
72497018|NCT01872338|144523664|SUPERIORITY|||||||0.23||||||repeated measures, overall time by condition effect|Regression, Linear|||||||.23
72497019|NCT03683394|144523675|SUPERIORITY||Mean Difference (Net)|0.15||||0.008|TWO_SIDED|95.0|0.04|0.26||Adjusted for baseline value, sex, race/ethnicity education, comorbidity score and phone assessment.|Mixed Models Analysis|Treatment effects were estimated using linear mixed models (LMMs) for the changes from baseline to each follow-up assessment.||||0.26|0.04|0.008
72497020|NCT03683394|144523676|SUPERIORITY||Mean Difference (Net)|0.11||||0.002|TWO_SIDED|95.0|0.02|0.21||Adjusted for baseline value, sex, race/ethnicity education, comorbidity score and phone assessment.|Mixed Models Analysis|Treatment effects were estimated using linear mixed models (LMMs) for the changes from baseline to each follow-up assessment.||||0.21|0.02|0.002
72497021|NCT03683394|144523677|SUPERIORITY||Mean Difference (Net)|1.11||||0.03|TWO_SIDED|95.0|0.08|2.14||Adjusted for baseline value, sex, race/ethnicity education, comorbidity score and phone assessment.|Mixed Models Analysis|Treatment effects were estimated using linear mixed models (LMMs) for the changes from baseline to each follow-up assessment.||||2.14|0.08|0.03
72497022|NCT03683394|144523678|SUPERIORITY||Odds Ratio (OR)|0.68||||0.52|TWO_SIDED|95.0|0.19|2.19||Adjusted for age and sex.|Fisher Exact|In an exploratory outcome, we examined incidence of a low CASI score or a diagnosis of MCI or dementia by treatment group.||||2.19|0.19|0.52
72497023|NCT00110019|144523679|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.01||||0.863|TWO_SIDED|95.0|0.87|1.18|||Log Rank|Stratified log rank test is used for overall survival comparison, stratified on AJCC stage, ECOG Performance status and prior therapy status|Arm II is the reference group|||1.18|0.87|0.863
72497024|NCT00110019|144523680|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.9||||0.092|TWO_SIDED|95.0|0.78|1.03||priori threshold for statistical significance: P\<0.05|Log Rank|Stratified log rank test is used for progression-free survival comparison, stratified on AJCC stage, ECOG Performance status and prior therapy status|Arm II is the reference group|||1.03|0.78|0.092
72497025|NCT00110019|144523681|SUPERIORITY_OR_OTHER|||||||0.427||95.0||||priori threshold for statistical significance: P\<0.05|Fisher Exact|||||||0.427
72497026|NCT00773279|144523710|NON_INFERIORITY_OR_EQUIVALENCE|"A two-sided 95 % Confidence Interval (CI) for the treatment difference, PDS290 minus FlexPen, in HbA1c after 12 weeks of treatment. PDS290 was to be declared non-inferior to FlexPen® if the upper limit of that CI would be less than the non-inferiority margin 0.40 % (absolute)."|Mean Difference (Final Values)|-0.047|STANDARD_ERROR_OF_MEAN|0.04||||95.0|-0.127|0.032|||Linear mixed effect model|Linear mixed effect model with period and delivery systems as fixed effects, and subject as a random effect.||The null hypothesis is that PDS290 be not non-inferior to FlexPen® with respect to HbA1c after 12 weeks of treatment; non-inferiority margin is 0.4 % (absolute).||0.032|-0.127|
72497027|NCT01107444|144523729|SUPERIORITY_OR_OTHER_LEGACY|||||||0.284||||||The t-test was based on the logarithm of the ratio of tumor size at Cycle 2 to that at baseline as this measure follows a normal distribution.|t-test, 1 sided|||||||0.284
72497028|NCT01948830|144523742|NON_INFERIORITY_OR_EQUIVALENCE|The following hypothesis was tested at a one-sided 0.025 level. Non-inferiority with respect to BCVA: H01: μtreat and extend - μmonthly ≤ - Δ versus HA1: μtreat and extend - μmonthly \> - Δ where μtreat and extend and μmonthly are the unknown mean changes from baseline in BCVA to Month 12 in the treat and extend regimen and the monthly regimen, respectively. Δ is the non-inferiority margin and is pre-defined to be 5 letters for the justification of the margin.|||||<|0.001|||||||ANCOVA|||||||<0.001
72497029|NCT01260454|144523770|SUPERIORITY_OR_OTHER|||||||0.03|TWO_SIDED||||||t-test, 2 sided|||This is open-label, uncontrolled data; the comparison is made between each individual's baseline.||||0.03
72497030|NCT02525549|144523793|NON_INFERIORITY|provides 85% power of success|Equivalence ratio|93.12|||||TWO_SIDED|90.0|88.6|102.0|||Fieller's method|||||102.00|88.6|
72560099|NCT00660387|144650690|SUPERIORITY_OR_OTHER||Treatment Difference (LS Mean)|-13.8|STANDARD_ERROR_OF_MEAN|3.5||0.0002|TWO_SIDED|95.0|-20.8|-6.8|||ANCOVA|Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding baseline as a covariate.||||-6.8|-20.8|0.0002
72388920|NCT01817530|144286166|SUPERIORITY|||||||0.002||||||P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.|Kruskal-Wallis|||Final Visit||||0.002
72388921|NCT01817530|144286166|SUPERIORITY|||||||0.329||||||P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.|Kruskal-Wallis|||Final Visit||||0.329
72388922|NCT01817530|144286167|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.|Kruskal-Wallis|||Month 3||||< 0.001
72388923|NCT01817530|144286167|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.|Kruskal-Wallis|||Month 3||||< 0.001
72388924|NCT01817530|144286167|SUPERIORITY|||||||0.036||||||P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.|Kruskal-Wallis|||Month 3||||0.036
72388925|NCT01817530|144286167|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.|Kruskal-Wallis|||Month 3||||< 0.001
72388926|NCT01817530|144286167|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.|Kruskal-Wallis|||Month 3||||< 0.001
72388927|NCT01817530|144286167|SUPERIORITY|||||||0.04||||||P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.|Kruskal-Wallis|||||||0.040
72388928|NCT01817530|144286167|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.|Kruskal-Wallis|||Month 6||||< 0.001
72388929|NCT01817530|144286167|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.|Kruskal-Wallis|||||||< 0.001
72388930|NCT01817530|144286167|SUPERIORITY|||||||0.098||||||P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.|Kruskal-Wallis|||Month 6||||0.098
72388931|NCT01817530|144286167|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.|Kruskal-Wallis|||Month 6||||< 0.001
72497031|NCT02525549|144523794|NON_INFERIORITY|provides 85% power of success|Equivalence ratio|98.7|||||TWO_SIDED|90.0|92.3|109.4|||Fieller's method|||||109.4|92.3|
72497032|NCT00778830|144523806|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.3176|||||TWO_SIDED|95.0|0.8078|2.1491||||||||2.1491|0.8078|
72497033|NCT02522767|144523904|SUPERIORITY||Odds Ratio (OR)|1.55|||>|0.05|TWO_SIDED|95.0|0.73|3.32||The p-value was based on chi-square test without a continuity correction.|Chi-squared|||Proportions were compared between treatment groups, at a two-sided 0.05 significance level.||3.32|0.73|>0.05
72560100|NCT00660387|144650691|SUPERIORITY_OR_OTHER||Treatment Difference (LS Mean)|-3.3|STANDARD_ERROR_OF_MEAN|5.1||0.5213|TWO_SIDED|95.0|-13.6|6.9|||ANCOVA|Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding baseline as a covariate.||||6.9|-13.6|0.5213
72497034|NCT02522767|144523907|SUPERIORITY||Odds Ratio (OR)|1.78|||>|0.05|TWO_SIDED|95.0|0.96|3.29||The p-value was based on chi-square test without a continuity correction.|Chi-squared|||Proportions were compared between treatment groups at a two-sided 0.05 significance level.||3.29|0.96|>0.05
72560101|NCT00660387|144650692|SUPERIORITY_OR_OTHER||Treatment Difference (LS Mean)|0.3|STANDARD_ERROR_OF_MEAN|0.3||0.3741|TWO_SIDED|95.0|-0.4|0.9|||ANCOVA|Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding baseline as a covariate.||||0.9|-0.4|0.3741
72560102|NCT00660387|144650693|SUPERIORITY_OR_OTHER||Treatment Difference (LS Mean)|-1.2|STANDARD_ERROR_OF_MEAN|0.6||0.0361|TWO_SIDED|95.0|-2.4|-0.1|||ANCOVA|Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding baseline as a covariate.||||-0.1|-2.4|0.0361
72560103|NCT00660387|144650694|SUPERIORITY_OR_OTHER||Treatment Difference (LS Mean)|-0.4|STANDARD_ERROR_OF_MEAN|0.4||0.3578|TWO_SIDED|95.0|-1.1|0.4|||ANCOVA|Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding baseline as a covariate.||||0.4|-1.1|0.3578
72560104|NCT00660387|144650695|SUPERIORITY_OR_OTHER||Treatment Difference (LS Mean)|-1.5|STANDARD_ERROR_OF_MEAN|2.9||0.6088|TWO_SIDED|95.0|-7.4|4.4|||ANCOVA|Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding baseline as a covariate.||||4.4|-7.4|0.6088
72388932|NCT01817530|144286167|SUPERIORITY|||||||0.014||||||P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.|Kruskal-Wallis|||Month 6||||0.014
72388933|NCT01817530|144286167|SUPERIORITY|||||||0.409||||||P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.|Kruskal-Wallis|||Month 6||||0.409
72388934|NCT01817530|144286167|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.|Kruskal-Wallis|||Final Visit||||< 0.001
72388935|NCT01817530|144286167|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.|Kruskal-Wallis|||Final Visit||||< 0.001
72388936|NCT01817530|144286167|SUPERIORITY|||||||0.094||||||P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.|Kruskal-Wallis|||Final Visit||||0.094
72388937|NCT01817530|144286167|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.|Kruskal-Wallis|||Final Visit||||< 0.001
72388938|NCT01817530|144286167|SUPERIORITY|||||||0.002||||||P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.|Kruskal-Wallis|||Final Visit||||0.002
72388939|NCT01817530|144286167|SUPERIORITY|||||||0.393||||||P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.|Kruskal-Wallis|||Final Visit||||0.393
72388940|NCT01817530|144286168|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.|Kruskal-Wallis|||Month 3||||< 0.001
72388941|NCT01817530|144286168|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.|Kruskal-Wallis|||Month 3||||< 0.001
72388942|NCT01817530|144286168|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.|Kruskal-Wallis|||Month 3||||< 0.001
72388943|NCT01817530|144286168|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.|Kruskal-Wallis|||Month 3||||< 0.001
72388944|NCT01817530|144286168|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.|Kruskal-Wallis|||Month 3||||< 0.001
72388945|NCT01817530|144286168|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.|Kruskal-Wallis|||Month 6||||< 0.001
72388946|NCT01817530|144286168|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.|Kruskal-Wallis|||Month 6||||< 0.001
72388947|NCT01817530|144286168|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.|Kruskal-Wallis|||Month 6||||< 0.001
72388948|NCT01817530|144286168|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.|Kruskal-Wallis|||Month 6||||< 0.001
72388949|NCT01817530|144286168|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.|Kruskal-Wallis|||Month 6||||< 0.001
72388950|NCT01817530|144286168|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.|Kruskal-Wallis|||Month 6||||< 0.001
72388951|NCT01817530|144286168|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.|Kruskal-Wallis|||Final Visit||||< 0.001
72388952|NCT01817530|144286168|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.|Kruskal-Wallis|||Final Visit||||< 0.001
72443621|NCT00567398|144401007|SUPERIORITY||Mean Difference (Final Values)|0.6|||<|0.001|TWO_SIDED|95.0|0.2|0.9|||ANOVA|||Month 3||0.9|0.2|<0.001
72443622|NCT00567398|144401007|SUPERIORITY||Mean Difference (Final Values)|0.5||||0.006|TWO_SIDED|95.0|0.1|0.8|||ANOVA|||Month 6||0.8|0.1|0.006
72443623|NCT00567398|144401008|SUPERIORITY||Mean Difference (Final Values)|5.0||||0.312|TWO_SIDED|95.0|-4.7|14.7|||ANOVA|||Insulin-Month 3||14.7|-4.7|0.312
72443624|NCT00567398|144401008|SUPERIORITY||Mean Difference (Final Values)|4.7||||0.342|TWO_SIDED|95.0|-5.0|14.4|||ANOVA|||Insulin-Month 6||14.4|-5.0|0.342
72443625|NCT00567398|144401010|SUPERIORITY||Mean Difference (Final Values)|0.5||||0.01|TWO_SIDED|95.0|0.1|0.9|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Cholesterol-Month 3||0.9|0.1|0.010
72443626|NCT00567398|144401010|SUPERIORITY||Median Difference (Final Values)|0.3||||0.073|TWO_SIDED|95.0|0.0|0.7|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Cholesterol-Month 6||0.7|0|0.073
72388953|NCT01817530|144286168|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.|Kruskal-Wallis|||Final Visit||||< 0.001
72388954|NCT01817530|144286168|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.|Kruskal-Wallis|||Final Visit||||< 0.001
72388955|NCT01817530|144286168|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.|Kruskal-Wallis|||Final Visit||||< 0.001
72388956|NCT01817530|144286168|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.|Kruskal-Wallis|||Final Visit||||< 0.001
72443627|NCT00567398|144401010|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.181|TWO_SIDED|95.0|-0.1|0.5|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for LDLC-Month 3||0.5|-0.1|0.181
72388957|NCT01817530|144286169|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Month 3||||< 0.001
72388958|NCT01817530|144286169|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Month 3||||< 0.001
72443628|NCT00567398|144401010|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.593|TWO_SIDED|95.0|-0.2|0.4|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for LDLC-Month 6||0.4|-0.2|0.593
72443629|NCT00567398|144401010|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.198|TWO_SIDED|95.0|-0.2|0.0|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for HDLC-Month 3||0|-0.2|0.198
72443630|NCT00567398|144401010|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.298|TWO_SIDED|95.0|-0.1|0.0|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for HDLC-Month 6||0|-0.1|0.298
72443631|NCT00567398|144401010|SUPERIORITY||Mean Difference (Final Values)|0.4|||<|0.001|TWO_SIDED|95.0|0.2|0.6|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for VLDL-Month 3||0.6|0.2|<0.001
72443632|NCT00567398|144401010|SUPERIORITY||Mean Difference (Final Values)|0.3||||0.003|TWO_SIDED|95.0|0.1|0.5|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for VLDL-Month 6||0.5|0.1|0.003
72443633|NCT00567398|144401010|SUPERIORITY||Mean Difference (Final Values)|0.8|||<|0.001|TWO_SIDED|95.0|0.4|1.3|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Triglycerides-Month 3||1.3|0.4|<0.001
72443634|NCT00567398|144401010|SUPERIORITY||Mean Difference (Final Values)|0.7||||0.002|TWO_SIDED|95.0|0.3|1.1|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Triglycerides-Month 6||1.1|0.3|0.002
72443635|NCT00567398|144401011|SUPERIORITY||Mean Difference (Final Values)|-2.3||||0.485|TWO_SIDED|95.0|-8.6|4.1|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Lp(a)-Month 3||4.1|-8.6|0.485
72443636|NCT00567398|144401011|SUPERIORITY||Mean Difference (Final Values)|-1.9||||0.556|TWO_SIDED|95.0|-8.2|4.4|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Lp(a)-Month 6||4.4|-8.2|0.556
72443637|NCT00567398|144401011|SUPERIORITY||Mean Difference (Final Values)|5.6||||0.101|TWO_SIDED|95.0|-1.1|12.2|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Apo A1-Month 3||12.2|-1.1|0.101
72388959|NCT01817530|144286169|SUPERIORITY|||||||0.02||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Month 3||||0.020
72388960|NCT01817530|144286169|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Month 3||||< 0.001
72443638|NCT00567398|144401011|SUPERIORITY||Mean Difference (Final Values)|5.0||||0.134|TWO_SIDED|95.0|-1.5|11.5|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Apo A1-Month 6||11.5|-1.5|0.134
72443639|NCT00567398|144401011|SUPERIORITY||Mean Difference (Final Values)|11.4||||0.004|TWO_SIDED|95.0|3.6|19.2|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Apo B-Month 3||19.2|3.6|0.004
72443640|NCT00567398|144401011|SUPERIORITY||Mean Difference (Final Values)|8.4||||0.03|TWO_SIDED|95.0|0.8|15.9|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Apo B-Month 6||15.9|0.8|0.030
72443641|NCT00567398|144401012|SUPERIORITY||Mean Difference (Final Values)|-56.5||||0.655|TWO_SIDED|95.0|-304.6|191.7|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Insulin-Month 3||191.7|-304.6|0.655
72560105|NCT00660387|144650696|SUPERIORITY_OR_OTHER||Treatment Difference (LS Mean)|11.4|STANDARD_ERROR_OF_MEAN|3.7||0.0033|TWO_SIDED|95.0|4.0|18.9|||ANCOVA|Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding baseline as a covariate.||||18.9|4.0|0.0033
72443642|NCT00567398|144401012|SUPERIORITY||Mean Difference (Final Values)|-29.2||||0.811|TWO_SIDED|95.0|-268.9|210.5|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Insulin-Month 6||210.5|-268.9|0.811
72443643|NCT00567398|144401012|SUPERIORITY||Mean Difference (Final Values)|441.3||||0.419|TWO_SIDED|95.0|-630.4|1513.1|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for C-Peptide-Month 3||1513.1|-630.4|0.419
72443644|NCT00567398|144401012|SUPERIORITY||Mean Difference (Final Values)|121.8||||0.82|TWO_SIDED|95.0|-927.9|1171.5|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for C-Peptide-Month 6||1171.5|-927.9|0.820
72443645|NCT00567398|144401013|SUPERIORITY||Mean Difference (Final Values)|-4.2||||0.721|TWO_SIDED|95.0|-27.5|19.0|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Pro-Insulin-Month 3||19|-27.5|0.721
72443646|NCT00567398|144401013|SUPERIORITY||Mean Difference (Final Values)|13.5||||0.247|TWO_SIDED|95.0|-9.4|36.4|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Pro-Insulin-Month 6||36.4|-9.4|0.247
72443647|NCT00567398|144401014|SUPERIORITY||Mean Difference (Final Values)|0.89||||0.624|TWO_SIDED|95.0|0.55|1.43|||ANOVA|||Estimates of Ratio-Month 6||1.43|0.55|0.624
72443648|NCT00567398|144401015|SUPERIORITY||Mean Difference (Final Values)|0.6||||0.338|TWO_SIDED|95.0|-0.6|1.8|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Albumin-Month 3||1.8|-0.6|0.338
72443649|NCT00567398|144401015|SUPERIORITY||Mean Difference (Final Values)|1.3||||0.029|TWO_SIDED|95.0|0.1|2.5|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Albumin-Month 6||2.5|0.1|0.029
72443650|NCT00567398|144401015|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.817|TWO_SIDED|95.0|-1.9|1.5|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Total Protein-Month 3||1.5|-1.9|0.817
72443651|NCT00567398|144401015|SUPERIORITY||Mean Difference (Final Values)|1.4||||0.091|TWO_SIDED|95.0|-0.2|2.9|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Total Protein-Month 6||2.9|-0.2|0.091
72443652|NCT00567398|144401016|SUPERIORITY||Mean Difference (Final Values)|-10.2||||0.127|TWO_SIDED|95.0|-23.3|2.9|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for PNA-Month 3||2.9|-23.3|0.127
72443653|NCT00567398|144401016|SUPERIORITY||Mean Difference (Final Values)|-10.3|||<|0.001|TWO_SIDED|95.0|-16.4|-4.3|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for PNA-Month 6||-4.3|-16.4|<0.001
72497035|NCT02522767|144523908|SUPERIORITY||Odds Ratio (OR)|1.3|||>|0.05|TWO_SIDED|95.0|0.78|2.15|||Generalized estimating equation approach|||Proportions were compared between treatment groups over 8 weeks, at a two-sided 0.05 significance level.||2.15|0.78|>0.05
72497036|NCT02522767|144523909|SUPERIORITY||Hazard Ratio (HR)|1.36|||>|0.05|TWO_SIDED|95.0|0.91|2.02||The p-value was based on log-rank test.|Log Rank||Hazard ratio and its 95% CI were obtained from Cox proportional hazards model with treatment group as a factor.|Times to normal stool pattern were compared between treatment groups, at a two-sided 0.05 significance level.||2.02|0.91|>0.05
72560106|NCT01863186|144650728|SUPERIORITY|||||||0.0166|||||||Pattern Mixture Model|||Due to the amount of missing data a pattern mixture model (or Jump to Reference) was utilized. The SOWS-Gossop total scores were log transformed. Each subjects available data Days 1-7 were included. The datasets created by the pattern mixture model were analyzed using a Mixed Model Repeated Measures model that included fixed effects for treatment group, baseline, sex, study day (1-7), and treatment group-by-day interaction. The overall estimate for each treatment group were compared.||||0.0166
72443654|NCT00567398|144401016|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.012|TWO_SIDED|95.0|-0.4|-0.1|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for nPNA-Month 3||-0.1|-0.4|0.012
72443655|NCT00567398|144401016|SUPERIORITY||Mean Difference (Final Values)|-0.2|||<|0.001|TWO_SIDED|95.0|-0.3|-0.1|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for nPNA-Month 6||-0.1|-0.3|<0.001
72443656|NCT00567398|144401017|SUPERIORITY||Mean Difference (Final Values)|3.2||||0.019|TWO_SIDED|95.0|0.5|5.8|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Pre-Albumin-Month 3||5.8|0.5|0.019
72443657|NCT00567398|144401017|SUPERIORITY||Mean Difference (Final Values)|3.0||||0.019|TWO_SIDED|95.0|0.5|5.6|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Pre-Albumin-Month 6||5.6|0.5|0.019
72443658|NCT00567398|144401018|SUPERIORITY||Mean Difference (Final Values)|-0.3||||0.884|TWO_SIDED|95.0|-3.9|3.4|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Drained Fat-Month 3||3.4|-3.9|0.884
72443659|NCT00567398|144401018|SUPERIORITY||Mean Difference (Final Values)|0.7||||0.716|TWO_SIDED|95.0|-3.0|4.3|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Drained Fat-Month 6||4.3|-3|0.716
72443660|NCT00567398|144401019|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.961|TWO_SIDED|95.0|-1.2|1.1|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for BMI-Month 3||1.1|-1.2|0.961
72443661|NCT00567398|144401019|SUPERIORITY||Mean Difference (Final Values)|0.3||||0.581|TWO_SIDED|95.0|-0.8|1.5|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for BMI-Month 6||1.5|-0.8|0.581
72443662|NCT00567398|144401020|SUPERIORITY||Mean Difference (Final Values)|-0.3||||0.871|TWO_SIDED|95.0|-3.7|3.1|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Waist Circumference-Month 6||3.1|-3.7|0.871
72443663|NCT00567398|144401021|SUPERIORITY||Mean Difference (Final Values)|5.2||||0.608|TWO_SIDED|95.0|-14.7|25.0|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Protein-Month 3||25|-14.7|0.608
72443664|NCT00567398|144401021|SUPERIORITY||Mean Difference (Final Values)|-1.7||||0.731|TWO_SIDED|95.0|-11.5|8.1|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Protein-Month 6||8.1|-11.5|0.731
72443665|NCT00567398|144401021|SUPERIORITY||Mean Difference (Final Values)|185.3||||0.377|TWO_SIDED|95.0|-227.5|598.1|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Calories-Month 3||598.1|-227.5|0.377
72443666|NCT00567398|144401021|SUPERIORITY||Mean Difference (Final Values)|-18.3||||0.854|TWO_SIDED|95.0|-214.4|177.8|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Calories-Month 6||177.8|-214.4|0.854
72560107|NCT01863186|144650728|SUPERIORITY|||||||0.0033|||||||Pattern Mixture Model|||Due to the amount of missing data a pattern mixture model (or Jump to Reference) was utilized. The SOWS-Gossop total scores were log transformed. Each subjects available data Days 1-7 were included. The datasets created by the pattern mixture model were analyzed using a Mixed Model Repeated Measures model that included fixed effects for treatment group, baseline, sex, study day (1-7), and treatment group-by-day interaction. The overall estimate for each treatment group were compared.||||0.0033
72560108|NCT00452348|144650756|SUPERIORITY_OR_OTHER||Least Squares Mean|0.04||||0.09||95.0|-0.01|0.09|||ANCOVA|||||0.09|-0.01|0.090
72560109|NCT00377156|144650829|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentage|-28.2|||<|0.001|TWO_SIDED|90.0|-41.9|-14.4|||Fisher Exact||Cognitive deterioration, the primary end point in evaluable patients at 3 months, was less frequent after Arm I than Arm II (40/63 \[63.5%\] vs 44/48 \[91.7%\],\> respectively. The percent difference was -28.2%; 90% CI, -41.9% to -14.4%; P \< .001).|||-14.4|-41.9|<0.001
72560110|NCT00377156|144650830|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentage|-18.4|||<|0.001|TWO_SIDED|95.0|-29.0|-7.8|||Fisher Exact|||||-7.8|-29.0|<0.001
72560111|NCT00377156|144650831|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|11.9||||0.001|TWO_SIDED|95.0|4.8|19.0|||t-test, 2 sided|||||19.0|4.8|0.001
72560112|NCT00377156|144650832|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-34.4||||0.04|TWO_SIDED|95.0|-74.4|5.5|||Fisher Exact||The incidence of cognitive deterioration was less in Arm I than Arm II at 12 months (6/10 \[60%\] vs 17/18 \[94.4%\]. The percent difference was -34.4% (95% CI: -74.4% to 5.5%; P = .04)|||5.5|-74.4|0.04
72560113|NCT00377156|144650833|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.02||||0.92|TWO_SIDED|95.0|0.75|1.38|||Regression, Cox|||||1.38|0.75|0.92
72560114|NCT00856349|144650835|SUPERIORITY_OR_OTHER||Increase in % on target (LIA)|13.6|||<|0.0001|||||||McNemar|||LIA (Lead Integrity Alert): Uploadable algorithm with the ability to increase the time between a lead fracture and potential delivery of an unnecessary shock.||||<0.0001
72560115|NCT00856349|144650835|SUPERIORITY_OR_OTHER||Increase in % on target (SVT Limit)|6.8|||<|0.0001|||||||McNemar|||SVT (Supraventricular Tachycardia) Limit: The maximum cycle length that Wavelet and PR logic will be applied to arrhythmias.||||<0.0001
72560116|NCT00856349|144650835|SUPERIORITY_OR_OTHER||Increase in % on target (VF NID PP)|9.0|||<|0.0001|||||||McNemar|||VF NID PP: Number of intervals to detect (NID) an arrhythmia in the VF zone for primary prevention (PP) patients.||||<0.0001
72560117|NCT00856349|144650835|SUPERIORITY_OR_OTHER||Increase in % on target (VF NID SP)|3.5||||0.0116|||||||McNemar|||VF NID SP: Number of intervals to detect (NID) an arrhythmia in the VF zone for secondary prevention (SP) patients.||||0.0116
72388961|NCT01817530|144286169|SUPERIORITY|||||||0.002||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Month 3||||0.002
72388962|NCT01817530|144286169|SUPERIORITY|||||||0.061||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Month 3||||0.061
72388963|NCT01817530|144286169|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Month 6||||< 0.001
72388964|NCT01817530|144286169|SUPERIORITY|||||||0.004||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Month 6||||0.004
72560118|NCT00856349|144650835|SUPERIORITY_OR_OTHER||Increase in % on target (Wavelet)|9.5|||<|0.0001|||||||McNemar|||Wavelet: Discriminator to help determine if arrhythmia is ventricular or supraventricular in single chamber ICDs.||||<0.0001
72388965|NCT01817530|144286169|SUPERIORITY|||||||0.085||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Month 6||||0.085
72388966|NCT01817530|144286169|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Month 6||||< 0.001
72388967|NCT01817530|144286169|SUPERIORITY|||||||0.012||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Month 6||||0.012
72388968|NCT01817530|144286169|SUPERIORITY|||||||0.049||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Month 6||||0.049
72560119|NCT00856349|144650835|SUPERIORITY_OR_OTHER||Increase in % on target (PR Logic)|3.2|||<|0.0001|||||||McNemar|||PR Logic: Discriminator to help determine if arrhythmia is ventricular or supraventricular in dual chamber ICDs and CRT-Ds.||||<0.0001
72560120|NCT02725515|144650841|SUPERIORITY||Risk Difference (RD)|13.4||||0.183|TWO_SIDED|95.0|-6.6|32.6|||Barnard's Unconditional Exact Test P-val|||||32.6|-6.6|0.1830
72560121|NCT02725515|144650842|SUPERIORITY||Risk Difference (RD)|17.5||||0.1075|TWO_SIDED|95.0|-3.7|37.3|||Barnard's Unconditional Exact Test P-val|||||37.3|-3.7|0.1075
72560122|NCT02725515|144650843|SUPERIORITY||Hazard Ratio (HR)|0.53||||0.0252|TWO_SIDED|95.0|0.3|0.92|||Log Rank|||||0.92|0.30|0.0252
72560123|NCT02898740|144650859|OTHER||Mean Difference (Net)|-3.4|STANDARD_ERROR_OF_MEAN|1.7|<|0.05|TWO_SIDED|95.0|-6.8|0.0|||Mixed Models Analysis|models were adjusted for age|treatment difference = Exercise - Health Education|||-0.0|-6.8|<0.05
72560124|NCT02697617|144650878|SUPERIORITY|||||||0.024||||||First analyzed using a Linear Mixed Model to assess if there were carryover effects and then subsequently analyzed using paired t-tests to compare the mean differences between treatments.|Paired t-test|||||||0.024
72443667|NCT00567398|144401022|SUPERIORITY||Mean Difference (Final Values)|0.02||||0.412|TWO_SIDED|95.0|-0.03|0.07|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for EQ 5D Questionnaire Index-Month 3||0.07|-0.03|0.412
72443668|NCT00567398|144401022|SUPERIORITY||Mean Difference (Final Values)|-0.02||||0.485|TWO_SIDED|95.0|-0.07|0.03|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for EQ 5D Questionnaire Index-Month 6||0.03|-0.07|0.485
72443669|NCT00567398|144401023|SUPERIORITY||Mean Difference (Final Values)|2.18||||0.525|TWO_SIDED|95.0|-4.56|8.93|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for EQ 5D Quest Health Status-Month 3||8.93|-4.56|0.525
72443670|NCT00567398|144401023|SUPERIORITY||Mean Difference (Final Values)|0.02||||0.995|TWO_SIDED|95.0|-6.79|6.83|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for EQ 5D Quest Health Status-Month 6||6.83|-6.79|0.995
72443671|NCT00567398|144401024|SUPERIORITY||Mean Difference (Final Values)|-1.87||||0.526|TWO_SIDED|95.0|-7.64|3.91|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Psychology Fatigue-Month 3||3.91|-7.64|0.526
72443672|NCT00567398|144401024|SUPERIORITY||Mean Difference (Final Values)|0.83||||0.779|TWO_SIDED|95.0|-5.01|6.68|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Psychology Fatigue-Month 6||6.68|-5.01|0.779
72443673|NCT00567398|144401024|SUPERIORITY||Mean Difference (Final Values)|-2.95||||0.246|TWO_SIDED|95.0|-7.95|2.04|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Psychology Cognitive-Month 3||2.04|-7.95|0.246
72443674|NCT00567398|144401024|SUPERIORITY||Mean Difference (Final Values)|-0.72||||0.78|TWO_SIDED|95.0|-5.78|4.34|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Psychology Cognitive-Month 6||4.34|-5.78|0.780
72443675|NCT00567398|144401024|SUPERIORITY||Mean Difference (Final Values)|0.41||||0.885|TWO_SIDED|95.0|-5.22|6.04|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Neurology Pain-Month 3||6.04|-5.22|0.885
72560125|NCT02697617|144650879|SUPERIORITY|||||||0.14||||||First analyzed using a Linear Mixed Model to assess if there were carryover effects and then subsequently analyzed using paired t-tests to compare the mean differences between treatments.|Paired t-test|||||||0.14
72443676|NCT00567398|144401024|SUPERIORITY||Mean Difference (Final Values)|4.41||||0.128|TWO_SIDED|95.0|-1.28|10.1|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Neurology Pain-Month 6||10.10|-1.28|0.128
72443677|NCT00567398|144401024|SUPERIORITY||Mean Difference (Final Values)|1.07||||0.701|TWO_SIDED|95.0|-4.4|6.54|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Neurology Sensory-Month 3||6.54|-4.40|0.701
72443678|NCT00567398|144401024|SUPERIORITY||Mean Difference (Final Values)|7.21||||0.01|TWO_SIDED|95.0|1.7|12.73|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Neurology Sensory-Month 6||12.73|1.70|0.010
72443679|NCT00567398|144401024|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.934|TWO_SIDED|95.0|-4.63|5.03|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Cardiology-Month 3||5.03|-4.63|0.934
72443680|NCT00567398|144401024|SUPERIORITY||Mean Difference (Final Values)|3.13||||0.209|TWO_SIDED|95.0|-1.75|8.01|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Cardiology-Month 6||8.01|-1.75|0.209
72443681|NCT00567398|144401024|SUPERIORITY||Mean Difference (Final Values)|1.89||||0.585|TWO_SIDED|95.0|-4.9|8.68|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Ophthalmology-Month 3||8.68|-4.90|0.585
72443682|NCT00567398|144401024|SUPERIORITY||Mean Difference (Final Values)|1.62||||0.641|TWO_SIDED|95.0|-5.22|8.47|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Ophthalmology-Month 6||8.47|-5.22|0.641
72443683|NCT00567398|144401024|SUPERIORITY||Mean Difference (Final Values)|-1.5||||0.586|TWO_SIDED|95.0|-6.89|3.9|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Hypoglycemia-Month 3||3.90|-6.89|0.586
72443684|NCT00567398|144401024|SUPERIORITY||Mean Difference (Final Values)|-0.33||||0.906|TWO_SIDED|95.0|-5.79|5.14|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Hypoglycemia-Month 6||5.14|-5.79|0.906
72443685|NCT00567398|144401024|SUPERIORITY||Mean Difference (Final Values)|-0.09||||0.97|TWO_SIDED|95.0|-4.93|4.75|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Hyperglycemia-Month 3||4.75|-4.93|0.970
72443686|NCT00567398|144401024|SUPERIORITY||Mean Difference (Final Values)|2.38||||0.34|TWO_SIDED|95.0|-2.52|7.28|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Hyperglycemia-Month 6||7.28|-2.52|0.340
72443687|NCT00567398|144401025|SUPERIORITY||Mean Difference (Final Values)|24.6||||0.495|TWO_SIDED|95.0|-46.9|96.0|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Abdominal Subcutaneous Fat Volume-Month 6||96|-46.9|0.495
72443688|NCT00567398|144401025|SUPERIORITY||Mean Difference (Final Values)|55.4||||0.081|TWO_SIDED|95.0|-7.0|117.8|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Abdominal Visceral Fat Volume-Month 6||117.8|-7|0.081
72443689|NCT00567398|144401026|SUPERIORITY||Mean Difference (Final Values)|6.3||||0.626|TWO_SIDED|95.0|-19.3|31.9|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for LV End Diastolic Volume-Month 6||31.9|-19.3|0.626
72443690|NCT00567398|144401026|SUPERIORITY||Mean Difference (Final Values)|7.8||||0.486|TWO_SIDED|95.0|-14.5|30.1|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for LV End Systolic Volume-Month 6||30.1|-14.5|0.486
72443691|NCT00567398|144401027|SUPERIORITY||Mean Difference (Final Values)|2.3||||0.832|TWO_SIDED|95.0|-18.9|23.4|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for LV Mass with Pap Muscles-Month 6||23.4|-18.9|0.832
72443692|NCT00567398|144401027|SUPERIORITY||Mean Difference (Final Values)|2.4||||0.82|TWO_SIDED|95.0|-18.3|23.1|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for LV Mass without Pap Muscles-Month 6||23.1|-18.3|0.820
72443693|NCT00567398|144401028|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.955|TWO_SIDED|95.0|-6.9|6.5|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for LV Ejection Fraction-Month 6||6.5|-6.9|0.955
72443694|NCT02488863|144401043|OTHER|ANOVA||||||0.0561|||||||ANOVA|||H0: mean(SPPB\_older\_pain) = mean(SPPB\_older\_no pain) = mean(SPPB\_younger)||||0.0561
72443695|NCT05145257|144401050|OTHER||||||<|0.001||||||Baseline versus endline comparison.|ANOVA|||||||<0.001
72443696|NCT05145257|144401051|OTHER||||||<|0.001||||||Baseline versus endline comparison.|ANOVA|||||||<0.001
72560126|NCT02697617|144650881|OTHER||||||||||||||||||comparison by paired t-test|||
72560127|NCT02697617|144650882|SUPERIORITY|||||||0.15||||||First analyzed using a Linear Mixed Model to assess if there were carryover effects and then subsequently analyzed using paired t-tests to compare the mean differences between treatments.|Paired t-test|||||||0.15
72443697|NCT05145257|144401052|OTHER||||||<|0.001||||||Baseline versus endline comparison.|ANOVA|||||||<0.001
72443698|NCT05145257|144401053|OTHER||||||<|0.001||||||Baseline versus endline comparison.|ANOVA|||||||<0.001
72443699|NCT05145257|144401054|OTHER||||||<|0.001||||||Baseline versus endline comparison.|ANOVA|||||||<0.001
72443700|NCT05145257|144401055|OTHER||||||<|0.001||||||Baseline versus endline comparison.|ANOVA|||||||<0.001
72443701|NCT05145257|144401056|OTHER||||||<|0.001||||||Baseline versus endline comparison.|ANOVA|||||||<0.001
72443702|NCT05145257|144401057|OTHER||||||<|0.001||||||Baseline versus endline comparison.|ANOVA|||||||<0.001
72443703|NCT05145257|144401058|OTHER||||||<|0.001||||||Baseline versus endline comparison.|ANOVA|||||||<0.001
72443704|NCT05145257|144401059|OTHER||||||<|0.001||||||Baseline versus endline comparison.|ANOVA|||||||<0.001
72443705|NCT05145257|144401060|OTHER||||||<|0.001||||||Baseline versus endline comparison.|ANOVA|||||||<0.001
72443706|NCT05145257|144401061|OTHER||||||<|0.001||||||Baseline versus endline comparison.|ANOVA|||||||<0.001
72443707|NCT05145257|144401062|OTHER||||||<|0.001||||||Baseline versus endline comparison.|ANOVA|||||||<0.001
72443708|NCT05145257|144401063|OTHER||||||<|0.001||||||Baseline versus endline comparison.|ANOVA|||||||<0.001
72443709|NCT05145257|144401064|OTHER||||||<|0.001||||||Baseline versus endline comparison.|ANOVA|||||||<0.001
72443710|NCT05145257|144401065|OTHER||||||<|0.001||||||Baseline versus endline comparison.|ANOVA|||||||<0.001
72443711|NCT05136404|144401080|OTHER||Ratio of Geometric Least Squares Mean|1.0|||||TWO_SIDED|90.0|0.937|1.08|||Mixed Models Analysis|||||1.08|0.937|
72497037|NCT02522767|144523910|SUPERIORITY||Treatment difference|-0.24|||<|0.05|TWO_SIDED|95.0|-0.41|-0.08|||Repeated-measures ANCOVA||A repeated-measures ANCOVA model with an unstructured correlation matrix was used to calculate estimate.|Change from baseline scores were compared between treatment groups over 8 weeks, at a two-sided 0.05 significance level.||-0.08|-0.41|<0.05
72443712|NCT05136404|144401080|OTHER||Ratio of Geometric Least Squares Mean|1.04|||||TWO_SIDED|90.0|0.968|1.11|||Mixed Models Analysis|||||1.11|0.968|
72443713|NCT05136404|144401081|OTHER||Ratio of Geometric Least Squares Mean|0.989|||||TWO_SIDED|90.0|0.953|1.03|||Mixed Models Analysis|||||1.03|0.953|
72443714|NCT05136404|144401081|OTHER||Ratio of Geometric Least Squares Mean|1.02|||||TWO_SIDED|90.0|0.982|1.06|||Mixed Models Analysis|||||1.06|0.982|
72443715|NCT05136404|144401082|OTHER||Ratio of Geometric Least Squares Mean|1.01|||||TWO_SIDED|90.0|0.972|1.06|||Mixed Models Analysis|||||1.06|0.972|
72560128|NCT02697617|144650883|SUPERIORITY|||||||0.4||||||First analyzed using a Linear Mixed Model to assess if there were carryover effects and then subsequently analyzed using paired t-tests to compare the mean differences between treatments.|paired t test|||||||0.4
72443716|NCT05136404|144401082|OTHER||Ratio of Geometric Least Squares Mean|1.03|||||TWO_SIDED|90.0|0.992|1.08|||Mixed Models Analysis|||||1.08|0.992|
72443717|NCT05136404|144401083|SUPERIORITY||Median Difference (Final Values)|0.0||||0.4728|TWO_SIDED|90.0|-0.5|0.0|||Sign test|||||0.00|-0.50|0.4728
72443718|NCT05136404|144401083|SUPERIORITY||Median Difference (Final Values)|0.0||||0.0142|TWO_SIDED|90.0|-0.5|0.0|||Sign test|||||0.00|-0.50|0.0142
72443719|NCT05623345|144401125|SUPERIORITY||Risk Difference (RD)|36.22|STANDARD_ERROR_OF_MEAN|17.43||0.0377|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.0377
72443720|NCT05623345|144401125|SUPERIORITY||Risk Difference (RD)|27.69|STANDARD_ERROR_OF_MEAN|5.68|<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<.0001
72443721|NCT05623345|144401125|SUPERIORITY||Risk Difference (RD)|24.44|STANDARD_ERROR_OF_MEAN|5.65|<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<.0001
72443722|NCT05623345|144401126|SUPERIORITY||Risk Difference (RD)|43.71|STANDARD_ERROR_OF_MEAN|22.14||0.0483|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.0483
72443723|NCT05623345|144401126|SUPERIORITY||Risk Difference (RD)|46.15|STANDARD_ERROR_OF_MEAN|7.62|<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<.0001
72443724|NCT05623345|144401126|SUPERIORITY||Risk Difference (RD)|52.8|STANDARD_ERROR_OF_MEAN|7.56|<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<.0001
72443725|NCT05623345|144401127|SUPERIORITY||Risk Difference (RD)|32.26|STANDARD_ERROR_OF_MEAN|18.93||0.0883|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.0883
72443726|NCT05623345|144401127|SUPERIORITY||Risk Difference (RD)|9.19|STANDARD_ERROR_OF_MEAN|8.35||0.2713|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.2713
72443727|NCT05623345|144401127|SUPERIORITY||Risk Difference (RD)|-1.2|STANDARD_ERROR_OF_MEAN|8.44||0.8872|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.8872
72443728|NCT05623345|144401128|SUPERIORITY||Risk Difference (RD)|23.45|STANDARD_ERROR_OF_MEAN|16.9||0.1654|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.1654
72443729|NCT05623345|144401128|SUPERIORITY||Risk Difference (RD)|26.58|STANDARD_ERROR_OF_MEAN|5.53|<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<.0001
72443730|NCT05623345|144401128|SUPERIORITY||Risk Difference (RD)|25.84|STANDARD_ERROR_OF_MEAN|5.55|<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<.0001
72443731|NCT05623345|144401129|SUPERIORITY||Risk Difference (RD)|43.09|STANDARD_ERROR_OF_MEAN|16.85||0.0106|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.0106
72443732|NCT05623345|144401129|SUPERIORITY||Risk Difference (RD)|28.46|STANDARD_ERROR_OF_MEAN|6.22|<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<.0001
72443733|NCT05623345|144401129|SUPERIORITY||Risk Difference (RD)|23.7|STANDARD_ERROR_OF_MEAN|6.4||0.0002|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.0002
72443734|NCT05623345|144401130|SUPERIORITY||Risk Difference (RD)|30.15|STANDARD_ERROR_OF_MEAN|19.11||0.1147|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.1147
72443735|NCT05623345|144401130|SUPERIORITY||Risk Difference (RD)|29.04|STANDARD_ERROR_OF_MEAN|5.92|<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<.0001
72497038|NCT02522767|144523911|SUPERIORITY||Treatment difference|-2.39|||>|0.05|TWO_SIDED|95.0|-5.46|0.67|||Repeated-measures ANCOVA||A repeated-measures ANCOVA model with an unstructured correlation matrix was used to calculate estimate.|Change from baseline scores were compared between treatment groups over 8 weeks, at a two-sided 0.05 significance level.||0.67|-5.46|>0.05
72497039|NCT02522767|144523912|SUPERIORITY||Treatment difference|-289.69|||<|0.05|TWO_SIDED|95.0|-514.96|-64.42|||ANCOVA||An ANCOVA model was used to calculate estimates.|Changes from baseline were compared between treatment groups, at a two-sided 0.05 significance level.||-64.42|-514.96|<0.05
72497040|NCT02522767|144523913|SUPERIORITY||Treatment difference|12.8|||<|0.05|TWO_SIDED|95.0|5.1|20.5|||Repeated-measures ANCOVA||A repeated-measures ANCOVA model with an unstructured correlation matrix was used to calculate estimates.|Change from baseline scores were compared between treatment groups over 8 weeks, at a two-sided 0.05 significance level.||20.50|5.10|<0.05
72497041|NCT01688050|144523939|OTHER|The primary safety endpoint of this study is analyzed using only descriptive statistics and it is not analyzed for the purpose of statistical inference|All-cause mortality rate (%)|2.0|||||TWO_SIDED|95.0|0.0|5.88|||||Wald method|||5.88|0|
72497042|NCT01688050|144523940|OTHER|The primary safety endpoint of this study is analyzed using only descriptive statistics and it is not analyzed for the purpose of statistical inference|Aortic injury-related mortality rate (%)|0.0|||||TWO_SIDED|95.0|0.0|7.1|||||Exact method|||7.1|0|
72497043|NCT01688050|144523941|OTHER|The primary effectiveness endpoint of this study is analyzed using only descriptive statistics and it is not analyzed for the purpose of statistical inference|Device success rate (%)|96.0|||||TWO_SIDED|95.0|90.6|100.0|||||Wald method|||100|90.6|
72497044|NCT00849667|144524009|SUPERIORITY||Hazard Ratio (HR)|0.99||||0.4513|TWO_SIDED|95.0|0.81|1.21|||Log Rank|One-sided log rank test||||1.21|0.81|0.4513
72497045|NCT00849667|144524009|SUPERIORITY||Hazard Ratio (HR)|0.86||||0.0761|TWO_SIDED|95.0|0.7|1.06|||Log Rank|One-sided log rank test||||1.06|0.70|0.0761
72497046|NCT00849667|144524010|SUPERIORITY||Hazard Ratio (HR)|0.99||||0.4823|TWO_SIDED|95.0|0.78|1.27|||Log Rank|One-sided log rank test||||1.27|0.78|0.4823
72497047|NCT00849667|144524010|SUPERIORITY||Hazard Ratio (HR)|0.88||||0.1616|TWO_SIDED|95.0|0.68|1.13|||Log Rank|One-sided log rank test||||1.13|0.68|0.1616
72497048|NCT00849667|144524011|SUPERIORITY||Hazard Ratio (HR)|0.93||||0.2938|TWO_SIDED|95.0|0.72|1.21|||Log Rank|One-sided log-rank test||||1.21|0.72|0.2938
72497049|NCT00849667|144524011|SUPERIORITY||Hazard Ratio (HR)|0.77||||0.0318|TWO_SIDED|95.0|0.58|1.02|||Log Rank|One-sided log-rank test||||1.02|0.58|0.0318
72497050|NCT00849667|144524012|SUPERIORITY||Hazard Ratio (HR)|1.01||||0.5636|TWO_SIDED|95.0|0.85|1.21|||Log Rank|One-sided log-rank test||||1.21|0.85|0.5636
72497051|NCT00849667|144524012|SUPERIORITY||Hazard Ratio (HR)|0.91||||0.156|TWO_SIDED|95.0|0.76|1.09|||Log Rank|One-sided log-rank test||||1.09|0.76|0.1560
72497052|NCT00849667|144524014|SUPERIORITY||Difference in percentage|1.8||||0.6864|TWO_SIDED|95.0|-5.4|9.0|||Cochran-Mantel-Haenszel|||||9.0|-5.4|0.6864
72443736|NCT05623345|144401130|SUPERIORITY||Risk Difference (RD)|24.99|STANDARD_ERROR_OF_MEAN|5.81|<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<.0001
72443737|NCT05623345|144401131|SUPERIORITY||LS Mean Difference|0.11|STANDARD_ERROR_OF_MEAN|0.166||0.514|TWO_SIDED|95.0|-0.22|0.44|||Mixed model repeated measures analysis|||||0.44|-0.22|0.514
72443738|NCT05623345|144401131|SUPERIORITY||LS Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.061||0.01|TWO_SIDED|95.0|-0.28|-0.04|||Mixed model repeated measures analysis|||||-0.04|-0.28|0.010
72497053|NCT00849667|144524014|SUPERIORITY||Difference in percentage|2.4||||0.4923|TWO_SIDED|95.0|-4.8|9.6|||Cochran-Mantel-Haenszel|||||9.6|-4.8|0.4923
72497054|NCT00849667|144524017|SUPERIORITY||Difference in percentage|-0.4||||0.8106|TWO_SIDED|95.0|-4.9|4.1|||Cochran-Mantel-Haenszel|||50% serological response||4.1|-4.9|0.8106
72497055|NCT00849667|144524017|SUPERIORITY||Difference in percentage|5.1||||0.0064|TWO_SIDED|95.0|1.4|8.8|||Cochran-Mantel-Haenszel|||50% serological response||8.8|1.4|0.0064
72497056|NCT00849667|144524017|SUPERIORITY||Difference in percentage|4.1||||0.3005|TWO_SIDED|95.0|-2.0|10.2|||Cochran-Mantel-Haenszel|||75% serological response||10.2|-2.0|0.3005
72497057|NCT00849667|144524017|SUPERIORITY||Difference in percentage|3.7||||0.2445|TWO_SIDED|95.0|-2.5|9.9|||Cochran-Mantel-Haenszel|||75% serological response||9.9|-2.5|0.2445
72497058|NCT00849667|144524017|SUPERIORITY||Difference in percentage|5.3||||0.2797|TWO_SIDED|95.0|-2.8|13.4|||Cochran-Mantel-Haenszel|||Serologic response leading to normalization||13.4|-2.8|0.2797
72497059|NCT00849667|144524017|SUPERIORITY||Difference in percentage|4.9||||0.2136|TWO_SIDED|95.0|-3.2|13.0|||Cochran-Mantel-Haenszel|||Serologic response leading to normalization||13.0|-3.2|0.2136
72497060|NCT01262625|144524034|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|the pre-defined non-inferiority margin of 1.25|Hazard Ratio (HR)|1.03||||0.19|TWO_SIDED|95.0|0.61|1.75|||Regression, Cox|||||1.75|0.61|0.19
72497061|NCT01262625|144524035|SUPERIORITY|||||||0.08|||||||DeLong|(DeLong et al 1988)||||||0.08
72497062|NCT01262625|144524035|SUPERIORITY|||||||0.02|||||||DeLong|(DeLong et al 1988)||||||0.02
72497063|NCT01214044|144524040|OTHER|A paired t-test was done to see if the time of the dim light melatonin onset changed from baseline to post-treatment.||||||0.2||||||A priori threshold for significance was p = 0.05.|t-test, 2 sided|paired t-test||A within subjects comparison was done to compare the time of the dim light melatonin onset before treatment with escitalopram (Study Visit 3) and after treatment with escitalopram (Study Visit 11).||||0.2
72497064|NCT01214044|144524041|OTHER|A paired t-test was done to see if the Hamilton-21 score decreased from baseline to post-treatment.||||||0.01||||||A priori threshold for significance was p = 0.05.|t-test, 1 sided|paired t-test||"We hypothesized that there would be a decrease in the Hamilton-21 score with escitalopram treatment.~A within subjects comparison was done to compare the Hamilton-21 score before treatment with escitalopram (Study Visit 3) and after treatment with escitalopram (Study Visit 11)."||||0.01
72560129|NCT01157234|144650893|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|28.73|||||TWO_SIDED|95.0|1.93|55.53||||||||55.53|1.93|
72560130|NCT01157234|144650894|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|8.27|||||TWO_SIDED|95.0|-12.58|29.12||||||||29.12|-12.58|
72388969|NCT01817530|144286169|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Final Visit||||< 0.001
72388970|NCT01817530|144286169|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Final Visit||||< 0.001
72388971|NCT01817530|144286169|SUPERIORITY|||||||0.056||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Final Visit||||0.056
72388972|NCT01817530|144286169|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Final Visit||||< 0.001
72388973|NCT01817530|144286169|SUPERIORITY|||||||0.005||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Final Visit||||0.005
72388974|NCT01817530|144286169|SUPERIORITY|||||||0.088||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Final Visit||||0.088
72388975|NCT01817530|144286170|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Month 3||||< 0.001
72388976|NCT01817530|144286170|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Month 3||||< 0.001
72388977|NCT01817530|144286170|SUPERIORITY|||||||0.188||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Month 3||||0.188
72388978|NCT01817530|144286170|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Month 3||||< 0.001
72388979|NCT01817530|144286170|SUPERIORITY|||||||0.001||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Month 3||||0.001
72388980|NCT01817530|144286170|SUPERIORITY|||||||0.104||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Month 3||||0.104
72388981|NCT01817530|144286170|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Month 6||||< 0.001
72388982|NCT01817530|144286170|SUPERIORITY|||||||0.021||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Month 6||||0.021
72388983|NCT01817530|144286170|SUPERIORITY|||||||0.859||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Month 6||||0.859
72388984|NCT01817530|144286170|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Month 6||||< 0.001
72388985|NCT01817530|144286170|SUPERIORITY|||||||0.006||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Month 6||||0.006
72388986|NCT01817530|144286170|SUPERIORITY|||||||0.015||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Month 6||||0.015
72388987|NCT01817530|144286170|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Final Visit||||< 0.001
72388988|NCT01817530|144286170|SUPERIORITY|||||||0.007||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Final Visit||||0.007
72388989|NCT01817530|144286170|SUPERIORITY|||||||0.722||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Final Visit||||0.722
72388990|NCT01817530|144286170|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Final Visit||||< 0.001
72560131|NCT01157234|144650895|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|1.23|STANDARD_ERROR_OF_MEAN|3.87|||TWO_SIDED|95.0|-6.74|9.2||||||||9.20|-6.74|
72560132|NCT01157234|144650899|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|11.94|||||TWO_SIDED|95.0|0.48|23.4||||||||23.40|0.48|
72560133|NCT01157234|144650900|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|69.54|STANDARD_ERROR_OF_MEAN|19.83|||TWO_SIDED|99.7|12.71|126.37||||||||126.37|12.71|
72443739|NCT05623345|144401131|SUPERIORITY||LS Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.061||0.006|TWO_SIDED|95.0|-0.29|-0.05|||Mixed model repeated measures analysis|||||-0.05|-0.29|0.006
72443740|NCT05384730|144401139|SUPERIORITY|||||||0.1|||||||ANOVA|||Light physical activity compared overtime||||0.10
72443741|NCT05384730|144401139|SUPERIORITY|||||||0.3|||||||ANOVA|||Moderate-vigorous physical activity compared overtime||||0.30
72443742|NCT05384730|144401139|SUPERIORITY|||||||0.18|||||||ANOVA|||Inactive/sedentary time compared overtime||||0.18
72443743|NCT05384730|144401140|SUPERIORITY|||||||0.14|||||||Chi-squared|||||||0.14
72443744|NCT05384730|144401141|SUPERIORITY|||||||0.01|||||||ANOVA|||||||0.01
72443745|NCT05384730|144401142|SUPERIORITY|||||||0.5|||||||ANOVA|||||||0.50
72443746|NCT05384730|144401143|SUPERIORITY|||||||0.03|||||||Chi-squared|||Comparing depression scores overtime||||0.03
72443747|NCT05384730|144401143|SUPERIORITY|||||||0.96|||||||Chi-squared|||Comparing anxiety scores overtime||||0.96
72443748|NCT05384730|144401144|SUPERIORITY|||||||0.04|||||||Chi-squared|||||||0.04
72443749|NCT05384730|144401145|SUPERIORITY|||||||0.13|||||||ANOVA|||||||0.13
72443750|NCT05384730|144401146|SUPERIORITY|||||||0.01|||||||ANOVA|||PASE analysis over time||||0.01
72443751|NCT01772472|144401147|SUPERIORITY||Hazard Ratio (HR)|0.54|||<|0.0001||95.0|0.44|0.66|||Log Rank|||||0.66|0.44|<0.0001
72443752|NCT01772472|144401148|SUPERIORITY||Hazard Ratio (HR)|0.54|||<|0.0001||95.0|0.44|0.66|||Log Rank|||||0.66|0.44|<0.0001
72443753|NCT01772472|144401149|SUPERIORITY||Hazard Ratio (HR)|0.54|||<|0.0001|TWO_SIDED|95.0|0.44|0.66|||Log Rank|||||0.66|0.44|<.0001
72443754|NCT01772472|144401150|SUPERIORITY||Hazard Ratio (HR)|0.57|||<|0.0001|TWO_SIDED|95.0|0.46|0.69|||Log Rank|||||0.69|0.46|<.0001
72443755|NCT01772472|144401151|SUPERIORITY||Hazard Ratio (HR)|0.57|||<|0.0001||95.0|0.46|0.69|||Log Rank|||||0.69|0.46|<0.0001
72443756|NCT01772472|144401152|SUPERIORITY||Hazard Ratio (HR)|0.57|||<|0.0001|TWO_SIDED|95.0|0.46|0.69|||Log Rank|||||0.69|0.46|<.0001
72443757|NCT01772472|144401153|SUPERIORITY||Hazard Ratio (HR)|0.58|||<|0.0001||95.0|0.48|0.7|||Log Rank|||||0.70|0.48|<0.0001
72443758|NCT01772472|144401154|SUPERIORITY||Hazard Ratio (HR)|0.58|||<|0.0001||95.0|0.48|0.7|||Log Rank|||||0.70|0.48|<0.0001
72443759|NCT01772472|144401155|SUPERIORITY||Hazard Ratio (HR)|0.58|||<|0.0001|TWO_SIDED|95.0|0.48|0.7|||Log Rank|||||0.70|0.48|<.0001
72560134|NCT01157234|144650901|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|68.19|STANDARD_ERROR_OF_MEAN|19.24|||TWO_SIDED|99.17|13.02|123.36||||||||123.36|13.02|
72443760|NCT01772472|144401156|SUPERIORITY||Hazard Ratio (HR)|0.7||||0.0082|TWO_SIDED|95.0|0.53|0.91|||Log Rank|||||0.91|0.53|0.0082
72443761|NCT01772472|144401157|SUPERIORITY||Hazard Ratio (HR)|0.7||||0.0082||95.0|0.53|0.91|||Log Rank|||||0.91|0.53|0.0082
72443762|NCT01772472|144401158|SUPERIORITY||Hazard Ratio (HR)|0.7||||0.0082|TWO_SIDED|95.0|0.53|0.91|||Log Rank|||||0.91|0.53|0.0082
72443763|NCT01772472|144401159|SUPERIORITY||Hazard Ratio (HR)|0.6|||<|0.0001||95.0|0.47|0.76|||Log Rank|||||0.76|0.47|<0.0001
72443764|NCT01772472|144401160|SUPERIORITY||Hazard Ratio (HR)|0.6|||<|0.0001||95.0|0.47|0.76|||Log Rank|||||0.76|0.47|<0.0001
72443765|NCT01772472|144401161|SUPERIORITY||Hazard Ratio (HR)|0.6|||<|0.0001|TWO_SIDED|95.0|0.47|0.76|||Log Rank|||||0.76|0.47|<.0001
72443766|NCT04349072|144401222|SUPERIORITY||Proportion Difference|58.93|||<|0.0001|TWO_SIDED|95.0|43.989|73.868|||Cochran-Mantel-Haenszel|||||73.868|43.989|<0.0001
72443767|NCT04349072|144401223|SUPERIORITY||Proportion Difference|41.07|||<|0.0001|TWO_SIDED|95.0|24.481|57.662|||Cochran-Mantel-Haenszel|||||57.662|24.481|<0.0001
72443768|NCT04349072|144401224|SUPERIORITY||Leat Square Mean of Treatment Difference|9.45|||<|0.0001|TWO_SIDED|95.0|4.868|14.041|||Mixed Models Analysis|Mixed model with repeated measure (MMRM)||||14.041|4.868|<0.0001
72443769|NCT04349072|144401225|SUPERIORITY||Mean Ratio|0.33|||<|0.0001|TWO_SIDED|95.0|0.266|0.421|||Mixed Models Analysis|Mixed model with repeated measure (MMRM)||||0.421|0.266|<0.0001
72443770|NCT04349072|144401226|SUPERIORITY||Mean Ratio|0.53|||<|0.0001|TWO_SIDED|95.0|0.406|0.7|||Mixed Models Analysis|Mixed model with repeated measure (MMRM)||||0.700|0.406|<0.0001
72443771|NCT04349072|144401227|SUPERIORITY||Leat Square Mean of Treatment Difference|-37.2|||<|0.0001|TWO_SIDED|95.0|-48.08|-26.24|||ANCOVA|||||-26.24|-48.08|<0.0001
72443772|NCT04093752|144401234|NON_INFERIORITY|The study was powered for superiority in HbA1c. The sample size provided \>99% power to show noninferiority assuming a 0.4% noninferiority (NI) boundary, 0.45% greater mean reduction in tirzepatide doses compared to insulin glargine, 1:1:1:1 randomization, a common standard deviation (SD) of 1.2%, one-sided significance level of 0.0125 and a dropout rate of 25%.|LS Mean Difference|-1.49|||||TWO_SIDED|95.0|-1.69|-1.29||||||||-1.29|-1.69|
72443773|NCT04093752|144401234|NON_INFERIORITY|The study was powered for superiority in HbA1c. The sample size provided \>99% power to show noninferiority assuming a 0.4% NI boundary, 0.45% greater mean reduction in tirzepatide doses compared to insulin glargine, 1:1:1:1 randomization, a common SD of 1.2%, one-sided significance level of 0.0125 and a dropout rate of 25%.|LS Mean Difference|-1.54|||||TWO_SIDED|95.0|-1.74|-1.34||||||||-1.34|-1.74|
72443774|NCT04093752|144401235|NON_INFERIORITY|The study was powered for superiority in HbA1c. The sample size provided \>99% power to show noninferiority assuming a 0.4% NI boundary, 0.45% greater mean reduction in tirzepatide doses compared to insulin glargine, 1:1:1:1 randomization, a common SD of 1.2%, one-sided significance level of 0.0125 and a dropout rate of 25%.|LS Mean Difference|-1.29|||||TWO_SIDED|95.0|-1.49|-1.09||||||||-1.09|-1.49|
72443775|NCT04093752|144401236|SUPERIORITY||LS Mean Difference|-6.5|||<|0.001|TWO_SIDED|95.0|-7.4|-5.6|||Mixed Models Analysis|||||-5.6|-7.4|<0.001
72443776|NCT04093752|144401236|SUPERIORITY||LS Mean Difference|-8.5|||<|0.001|TWO_SIDED|95.0|-9.5|-7.6|||Mixed Models Analysis|||||-7.6|-9.5|<0.001
72443777|NCT04093752|144401236|SUPERIORITY||LS Mean Difference|-8.7|||<|0.001|TWO_SIDED|95.0|-9.6|-7.7|||Mixed Models Analysis|||||-7.7|-9.6|<0.001
72443778|NCT04093752|144401237|SUPERIORITY||Odds Ratio (OR)|14.54|||<|0.001|TWO_SIDED|95.0|8.94|23.64|||Regression, Logistic|||||23.64|8.94|<0.001
72443779|NCT04093752|144401237|SUPERIORITY||Odds Ratio (OR)|28.76|||<|0.001|TWO_SIDED|95.0|16.72|49.49|||Regression, Logistic|||||49.49|16.72|<0.001
72443780|NCT04093752|144401237|SUPERIORITY||Odds Ratio (OR)|25.27|||<|0.001|TWO_SIDED|95.0|14.88|42.95|||Regression, Logistic|||||42.95|14.88|<0.001
72560135|NCT01157234|144650902|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|1.39|STANDARD_ERROR_OF_MEAN|17.32|||TWO_SIDED|99.17|-48.25|51.03||||||||51.03|-48.25|
72443781|NCT04093752|144401238|SUPERIORITY||Odds Ratio (OR)|82.54||||0.002|TWO_SIDED|95.0|5.13|1327.81|||Regression, Logistic|||||1327.81|5.13|0.002
72443782|NCT04093752|144401238|SUPERIORITY||Odds Ratio (OR)|124.76|||<|0.001|TWO_SIDED|95.0|7.79|1997.01|||Regression, Logistic|||||1997.01|7.79|<0.001
72497065|NCT01214044|144524042|OTHER|A paired t-test was done to see if the Beck Depression Inventory-II score decreased from baseline to post-treatment.||||||0.14||||||A priori threshold for significance was p = 0.05.|t-test, 1 sided|paired t-test||"We hypothesized that there would be a decrease in the Beck Depression Inventory-II score with escitalopram treatment.~A within subjects comparison was done to compare the Beck Depression Inventory-II score before treatment with escitalopram (Study Visit 3) and after treatment with escitalopram (Study Visit 11)."||||0.14
72497066|NCT01214044|144524043|OTHER|Spearman's rank-order correlation (non-parametric test) was used.||||||0.06||||||Spearman's rho (rs) = 0.66|Spearman's rank-order correlation|||We hypothesized that there would be a correlation between the change in phase angle difference and the decrease in the Hamilton-21 score with escitalopram treatment. The phase angle difference is the interval, in hours, between the dim light melatonin onset (a marker of biological time) and the average midpoint of sleep during the prior week.||||0.06
72497067|NCT01214044|144524043|OTHER|Spearman's rank-order correlation (non-parametric test) was used.||||||0.48||||||Spearman's rho (rs) = 0.02|Spearman's rank-order correlation|||We hypothesized that there would be a correlation between the change in phase angle difference and the decrease in the Beck Depression Inventory-II score with escitalopram treatment. The phase angle difference is the interval, in hours, between the dim light melatonin onset (a marker of biological time) and the average midpoint of sleep during the prior week.||||0.48
72497068|NCT04698525|144524044|NON_INFERIORITY|"A new treatment (memantine) that is not much worse or non-inferior to the standard treatment (valproate) may be attractive if, compared to it, it is expected to cause fewer side effects or improve quality of life or if its dosing regimen is easier to tolerate."|Mean Difference (Final Values)|5.3|STANDARD_DEVIATION|14.0||0.9|TWO_SIDED|95.0|0.0|10.0||"Comparison between VPA and Memantine was:~0.9 p-value (two-tailed)"|Wilcoxon (Mann-Whitney)|"Memantine 3.534 z corrected for ties 0.0004 p-value (two-tailed)~VPA 3.418 z corrected for ties 0.0006 p-value (two-tailed)"||Null hypothesis: Memantine is as effective as valproate in treating episodic migraine.|We made also student t|10|0|0.9
72497069|NCT05384041|144524049|SUPERIORITY|||||||0.056|||||||Regression, Linear|||Intent to Treat analyses||||0.056
72497070|NCT05384041|144524050|SUPERIORITY|||||||0.048|||||||t-test, 2 sided|||Difference (Active - Control) at Week 1||||0.048
72497071|NCT05384041|144524051|SUPERIORITY|||||||0.2595|||||||t-test, 2 sided|||Difference (Active-Control) at Week 1||||0.2595
72497072|NCT05384041|144524051|SUPERIORITY|||||||0.1286|||||||t-test, 2 sided|||Difference (Active-Control) at Week 2||||0.1286
72497073|NCT05384041|144524051|SUPERIORITY|||||||0.1449|||||||t-test, 2 sided|||Difference (Active-Control) at Week 4||||0.1449
72497074|NCT05384041|144524052|SUPERIORITY|||||||0.2065|||||||t-test, 2 sided|||Difference (Active-Control) at Week 1||||0.2065
72443783|NCT04093752|144401238|SUPERIORITY||Odds Ratio (OR)|184.9|||<|0.001|TWO_SIDED|95.0|11.59|2950.73|||Regression, Logistic|||||2950.73|11.59|<0.001
72443784|NCT04093752|144401239|SUPERIORITY||LS Mean Difference|-12.3|||<|0.001|TWO_SIDED|95.0|-18.3|-6.3|||Mixed Models Analysis|||||-6.3|-18.3|<0.001
72497075|NCT05384041|144524052|SUPERIORITY|||||||0.1349|||||||t-test, 2 sided|||Difference (Active-Control) at Week 2||||0.1349
72497076|NCT05384041|144524052|SUPERIORITY|||||||0.1142|||||||t-test, 2 sided|||Difference (Active-Control) at Week 4||||0.1142
72497077|NCT05384041|144524053|SUPERIORITY|||||||0.231|||||||Chi-squared|||Difference (Active-Control) at Week 1||||0.231
72497078|NCT05384041|144524053|SUPERIORITY|||||||0.192|||||||Chi-squared|||Difference (Active-Control) at Week 2||||0.192
72497079|NCT05384041|144524053|SUPERIORITY|||||||0.045|||||||Chi-squared|||Difference (Active-Control) at Week 4||||0.045
72443785|NCT04093752|144401239|SUPERIORITY||LS Mean Difference|-20.0|||<|0.001|TWO_SIDED|95.0|-26.1|-13.9|||Mixed Models Analysis|||||-13.9|-26.1|<0.001
72443786|NCT04093752|144401239|SUPERIORITY||LS Mean Difference|-18.6|||<|0.001|TWO_SIDED|95.0|-24.6|-12.5|||Mixed Models Analysis|||||-12.5|-24.6|<0.001
72443787|NCT04093752|144401240|SUPERIORITY||LS Mean Difference|-34.2|||<|0.001|TWO_SIDED|95.0|-40.1|-28.3|||Mixed Models Analysis|||||-28.3|-40.1|<0.001
72497080|NCT05384041|144524055|SUPERIORITY|||||||0.005|||||||Regression, Linear|||||||0.005
72497081|NCT05384041|144524056|SUPERIORITY|||||||0.0026|||||||Regression, Linear|||Difference (Active-Control) at Week 1||||0.0026
72619164|NCT03016403|144769032|SUPERIORITY||Mean Difference (Final Values)|-7.73||||0.21|TWO_SIDED|95.0|-19.73|4.27||Since there are three primary outcomes (depression, anxiety and coping scores) in the study, the significance level was set a priori at 0.0167 (alpha = 0.05/3).|Mixed Models Analysis|The pvalue corresponds to the hypothesis of the interaction effect between time and group (intervention arm).|The estimate represents the difference in expected means at the 6-month time point between the intervention and usual care arms.|A linear mixed model (LMM) with random intercepts for both patients and clinics has been used, with adjustment for cancer type and cancer stage. The study was powered for testing the hypothesis of no group differences in change over the four time points (baseline, 6-weeks, 3-months and 6-months). A significant group by time interaction was hypothesized.||4.27|-19.73|0.21
72443788|NCT04093752|144401240|SUPERIORITY||LS Mean Difference|-40.6|||<|0.001|TWO_SIDED|95.0|-46.7|-34.6|||Mixed Models Analysis|||||-34.6|-46.7|<0.001
72497082|NCT05384041|144524056|SUPERIORITY|||||||0.4706|||||||Regression, Linear|||Difference (Active-Control) at Week 1||||0.4706
72497083|NCT05384041|144524056|SUPERIORITY|||||||0.0197|||||||Regression, Linear|||Difference (Active-Control) at Week 2||||0.0197
72497084|NCT05384041|144524056|SUPERIORITY|||||||0.4858|||||||Regression, Linear|||Difference (Active-Control) at Week 2||||0.4858
72497085|NCT05384041|144524056|SUPERIORITY|||||||0.0183|||||||Regression, Linear|||Difference (Active-Control) at Week 4||||0.0183
72497086|NCT05384041|144524056|SUPERIORITY|||||||0.7885|||||||Regression, Linear|||Difference (Active-Control) at Week 4||||0.7885
72497087|NCT05384041|144524057|SUPERIORITY||||||<|0.001|||||||Regression, Linear|||Difference (Active-Control) at Week 1||||<0.001
72497088|NCT05384041|144524057|SUPERIORITY|||||||0.45|||||||Regression, Linear|||Difference (Active-Control) at Week 1||||0.450
72497089|NCT05384041|144524057|SUPERIORITY|||||||0.008|||||||Regression, Linear|||Difference (Active-Control) at Week 2||||0.008
72560136|NCT01157234|144650903|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|2.74|STANDARD_ERROR_OF_MEAN|17.96|||TWO_SIDED|99.17|-48.74|54.22||||||||54.22|-48.74|
72560137|NCT02733627|144650951|OTHER||Slope|3.8266|STANDARD_ERROR_OF_MEAN|0.2967|||TWO_SIDED|95.0|3.2155|4.4376||||||The basic model for the investigation of dose proportionality was a power model. The model consisted of a regression model applied to log-transformed data. The corresponding ANCOVA model included the logarithm of the dose as a covariate. The assumption of a linear relationship between the log-transformed pharmacokinetic endpoint and the log-transformed dose was checked.|Standard Error of the mean is actually Standard Error of the slope. Based on the estimate for slope parameter (β), a 2-sided 95% CI for the slope was computed. Perfect dose proportionality would correspond to a slope of 1.|4.4376|3.2155|
72560138|NCT02733627|144650952|OTHER||Slope|4.181|STANDARD_ERROR_OF_MEAN|0.3247|||TWO_SIDED|95.0|3.5094|4.8527||||||The basic model for the investigation of dose proportionality was a power model. The model consisted of a regression model applied to log-transformed data. The corresponding ANCOVA model included the logarithm of the dose as a covariate. The assumption of a linear relationship between the log-transformed pharmacokinetic endpoint and the log-transformed dose was checked.|Standard Error of the mean is actually Standard Error of the slope. Based on the estimate for slope parameter (β), a 2-sided 95% CI for the slope was computed. Perfect dose proportionality would correspond to a slope of 1.|4.8527|3.5094|
72560139|NCT02733627|144650953|OTHER||Slope|1.8868|STANDARD_ERROR_OF_MEAN|0.3069|||TWO_SIDED|95.0|1.2503|2.5234||||||The basic model for the investigation of dose proportionality was a power model. The model consisted of a regression model applied to log-transformed data. The corresponding ANCOVA model included the logarithm of the dose as a covariate. The assumption of a linear relationship between the log-transformed pharmacokinetic endpoint and the log-transformed dose was checked.|Standard Error of the mean is actually Standard Error of the slope. Based on the estimate for slope parameter (β), a 2-sided 95% CI for the slope was computed. Perfect dose proportionality would correspond to a slope of 1.|2.5234|1.2503|
72560140|NCT02733627|144650954|OTHER||Slope|3.0677|STANDARD_ERROR_OF_MEAN|0.4844|||TWO_SIDED|95.0|2.0631|4.0723||||||The basic model for the investigation of dose proportionality was a power model. The model consisted of a regression model applied to log-transformed data. The corresponding ANCOVA model included the logarithm of the dose as a covariate. The assumption of a linear relationship between the log-transformed pharmacokinetic endpoint and the log-transformed dose was checked.|Standard Error of the mean is actually Standard Error of the slope. Based on the estimate for slope parameter (β), a 2-sided 95% CI for the slope was computed. Perfect dose proportionality would correspond to a slope of 1.|4.0723|2.0631|
72560141|NCT00183196|144650955|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.529|STANDARD_ERROR_OF_MEAN|4.0|||TWO_SIDED|95.0|0.281|0.997|||Regression, Cox|||||.997|.281|
72560142|NCT00183196|144650955|SUPERIORITY|||||||0.04|||||||Regression, Cox|percent heavy drinking days at baseline was used as a covariate in the analysis as it was a predictor of overall survival independent of group.||||||0.04
72560143|NCT01513239|144650956|SUPERIORITY_OR_OTHER||Adjusted Difference|-10.7|||<|0.0001|TWO_SIDED|95.0|-16.4|-5.1||One sided p-value based on the Miettinen and Nurminen method stratified by SOC therapy (metronidazole vs. vancomycin vs. fidaxomicin) and hospitalization status (inpatient vs. outpatient)|Miettinen and Nurminen||MK-3415A + SOC minus Placebo + SOC|||-5.1|-16.4|<0.0001
72560144|NCT01513239|144650956|SUPERIORITY_OR_OTHER||Adjusted Difference|-9.9||||0.0003|TWO_SIDED|95.0|-15.5|-4.3||One sided p-value based on the Miettinen and Nurminen method stratified by SOC therapy (metronidazole vs. vancomycin vs. fidaxomicin) and hospitalization status (inpatient vs. outpatient)|Miettinen and Nurminen||MK-6072 + SOC minus Placebo + SOC|||-4.3|-15.5|0.0003
72560145|NCT01513239|144650956|SUPERIORITY_OR_OTHER||Adjusted Difference|-0.8||||0.3718|TWO_SIDED|95.0|-5.9|4.2||One sided p-value based on the Miettinen and Nurminen method stratified by SOC therapy (metronidazole vs. vancomycin vs. fidaxomicin) and hospitalization status (inpatient vs. outpatient)|Miettinen and Nurminen||MK-3415A + SOC minus MK-6072 + SOC|||4.2|-5.9|0.3718
72497090|NCT05384041|144524057|SUPERIORITY|||||||0.438|||||||Regression, Linear|||Difference (Active-Control) at Week 2||||0.438
72497091|NCT05384041|144524057|SUPERIORITY|||||||0.016|||||||Regression, Linear|||Difference (Active-Control) at Week 4||||0.016
72560146|NCT01513239|144650957|SUPERIORITY_OR_OTHER||Adjusted Difference|5.2||||0.0722|TWO_SIDED|95.0|-1.8|12.2||One sided p-value based on the Miettinen and Nurminen method stratified by SOC therapy (metronidazole vs. vancomycin vs. fidaxomicin) and hospitalization status (inpatient vs. outpatient)|Miettinen and Nurminen||MK-3415A + SOC minus Placebo + SOC|||12.2|-1.8|0.0722
72560147|NCT01513239|144650957|SUPERIORITY_OR_OTHER||Adjusted Difference|14.6|||<|0.0001|TWO_SIDED|95.0|7.7|21.4||One sided p-value based on the Miettinen and Nurminen method stratified by SOC therapy (metronidazole vs. vancomycin vs. fidaxomicin) and hospitalization status (inpatient vs. outpatient)|Miettinen and Nurminen||MK-6072 + SOC minus Placebo + SOC|||21.4|7.7|<0.0001
72619165|NCT03016403|144769033|SUPERIORITY||Mean Difference (Final Values)|1.52||||0.052|TWO_SIDED|95.0|-0.01|3.05||Since there are three primary outcomes (depression, anxiety and coping scores) in the study, the significance level was set a priori at 0.0167 (alpha = 0.05/3).|Mixed Models Analysis|The pvalue corresponds to the hypothesis of the interaction effect between time and group (intervention arm).|The estimate represents the difference in expected means at the 6-month time point between the intervention and usual care arms.|A linear mixed model (LMM) with random intercepts for both patients and clinics has been used, with adjustment for cancer type and cancer stage. The study was powered for testing the hypothesis of no group differences in change over the four time points (baseline, 6-weeks, 3-months and 6-months). A significant group by time interaction was hypothesized.||3.05|-0.01|0.052
72497092|NCT05384041|144524057|SUPERIORITY|||||||0.355|||||||Regression, Linear|||Difference (Active-Control) at Week 4||||0.355
72622390|NCT00855166|144774682|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.94|STANDARD_ERROR_OF_MEAN|0.6473||0.1521|TWO_SIDED|95.0|-2.21|0.35||Exploratory. Model including fixed categorical effects of treatment, week, treatment-by-week interaction, gender and rescue medication as well as continuous fixed covariates of baseline measurement and baseline measurement-by-week interaction.|Mixed Models Analysis|Percent change in BMD from baseline to week 102 evaluated via longitudinal repeated measures analysis using direct likelihood.|Natural logarithms of baseline and week 102 values were used.|H0: mean(treat) minus mean(placebo) = 0 versus the alternative HA: mean(treat) minus mean(placebo) =/= 0||0.35|-2.21|0.1521
72497093|NCT05384041|144524058|SUPERIORITY|||||||0.046|||||||Regression, Linear|||Difference (Active-Control) at Week 1||||0.046
72560148|NCT01513239|144650957|SUPERIORITY_OR_OTHER||Adjusted Difference|-9.4||||0.9969|TWO_SIDED|95.0|-16.1|-2.7||One sided p-value based on the Miettinen and Nurminen method stratified by SOC therapy (metronidazole vs. vancomycin vs. fidaxomicin) and hospitalization status (inpatient vs. outpatient)|Miettinen and Nurminen||MK-3415A + SOC minus MK-6072 + SOC|||-2.7|-16.1|0.9969
72560149|NCT01513239|144650958|SUPERIORITY_OR_OTHER||Adjusted Difference|-11.9||||0.0006|TWO_SIDED|95.0|-19.0|-4.7||One sided p-value based on the Miettinen and Nurminen method stratified by SOC therapy (metronidazole vs. vancomycin vs. fidaxomicin) and hospitalization status (inpatient vs. outpatient)|Miettinen and Nurminen||MK-3415A + SOC minus Placebo + SOC|||-4.7|-19.0|0.0006
72619166|NCT03016403|144769034|SUPERIORITY||Mean Difference (Final Values)|0.91||||0.214|TWO_SIDED|95.0|-0.52|2.36||Since there are three primary outcomes (depression, anxiety and coping scores) in the study, the significance level was set a priori at 0.0167 (alpha = 0.05/3).|Mixed Models Analysis|The pvalue corresponds to the hypothesis of the interaction effect between time and group (intervention arm).|The estimate represents the difference in expected means at the 6-month time point between the intervention and usual care arms.|A linear mixed model (LMM) with random intercepts for both patients and clinics has been used, with adjustment for cancer type and cancer stage. The study was powered for testing the hypothesis of no group differences in change over the four time points (baseline, 6-weeks, 3-months and 6-months). A significant group by time interaction was hypothesized.||2.36|-0.52|0.214
72560150|NCT01513239|144650958|SUPERIORITY_OR_OTHER||Adjusted Difference|-13.7|||<|0.0001|TWO_SIDED|95.0|-20.4|-6.9||One sided p-value based on the Miettinen and Nurminen method stratified by SOC therapy (metronidazole vs. vancomycin vs. fidaxomicin) and hospitalization status (inpatient vs. outpatient)|Miettinen and Nurminen||MK-6072 + SOC minus Placebo + SOC|||-6.9|-20.4|<0.0001
72560151|NCT01513239|144650958|SUPERIORITY_OR_OTHER||Adjusted Difference|1.6||||0.6962|TWO_SIDED|95.0|-4.6|8.0||One sided p-value based on the Miettinen and Nurminen method stratified by SOC therapy (metronidazole vs. vancomycin vs. fidaxomicin) and hospitalization status (inpatient vs. outpatient)|Miettinen and Nurminen||MK-3415A + SOC minus MK-6072 + SOC|||8.0|-4.6|0.6962
72388991|NCT01817530|144286170|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Final Visit||||< 0.001
72388992|NCT01817530|144286170|SUPERIORITY|||||||0.032||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Final Visit||||0.032
72388993|NCT01817530|144286171|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Month 3||||< 0.001
72388994|NCT01817530|144286171|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Month 3||||< 0.001
72388995|NCT01817530|144286171|SUPERIORITY|||||||0.041||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Month 3||||0.041
72388996|NCT01817530|144286171|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Month 3||||< 0.001
72388997|NCT01817530|144286171|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Month 3||||< 0.001
72388998|NCT01817530|144286171|SUPERIORITY|||||||0.008||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Month 3||||0.008
72388999|NCT01817530|144286171|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Month 6||||< 0.001
72389000|NCT01817530|144286171|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Month 6||||< 0.001
72389001|NCT01817530|144286171|SUPERIORITY|||||||0.003||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Month 6||||0.003
72389002|NCT01817530|144286171|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Month 6||||< 0.001
72389003|NCT01817530|144286171|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Month 6||||< 0.001
72389004|NCT01817530|144286171|SUPERIORITY|||||||0.003||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Month 6||||0.003
72389005|NCT01817530|144286171|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Final Visit||||< 0.001
72389006|NCT01817530|144286171|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Final Visit||||< 0.001
72443789|NCT04093752|144401240|SUPERIORITY||LS Mean Difference|-41.8|||<|0.001|TWO_SIDED|95.0|-47.9|-35.8|||Mixed Models Analysis|||||-35.8|-47.9|<0.001
72443790|NCT04093752|144401241|SUPERIORITY||Odds Ratio (OR)|21.89|||<|0.001|TWO_SIDED|95.0|11.63|41.2|||Regression, Logistic|||||41.20|11.63|<0.001
72443791|NCT04093752|144401241|SUPERIORITY||Odds Ratio (OR)|43.79|||<|0.001|TWO_SIDED|95.0|22.96|83.5|||Regression, Logistic|||||83.50|22.96|<0.001
72443792|NCT04093752|144401241|SUPERIORITY||Odds Ratio (OR)|48.41|||<|0.001|TWO_SIDED|95.0|25.34|92.49|||Regression, Logistic|||||92.49|25.34|<0.001
72443793|NCT04093752|144401242|SUPERIORITY||LS Mean Difference|-0.47||||0.007|TWO_SIDED|95.0|-0.81|-0.13|||ANCOVA|||Hyperglycemia||-0.13|-0.81|0.007
72443794|NCT04093752|144401242|SUPERIORITY||LS Mean Difference|-0.77|||<|0.001|TWO_SIDED|95.0|-1.11|-0.43|||ANCOVA|||Hyperglycemia||-0.43|-1.11|<0.001
72443795|NCT04093752|144401242|SUPERIORITY||LS Mean Difference|-0.71|||<|0.001|TWO_SIDED|95.0|-1.05|-0.36|||ANCOVA|||Hyperglycemia||-0.36|-1.05|<0.001
72443796|NCT04093752|144401242|SUPERIORITY||LS Mean Difference|-0.14||||0.384|TWO_SIDED|95.0|-0.46|0.18|||ANCOVA|||Hypoglycemia||0.18|-0.46|0.384
72443797|NCT04093752|144401242|SUPERIORITY||LS Mean Difference|-0.17||||0.307|TWO_SIDED|95.0|-0.49|0.16|||ANCOVA|||Hypoglycemia||0.16|-0.49|0.307
72560152|NCT01513239|144650959|SUPERIORITY_OR_OTHER||Difference in Percentages|-2.9||||0.408|TWO_SIDED|95.0|-9.8|4.0|||Miettinen and Nurminen||MK-3415A + SOC minus Placebo +SOC|||4.0|-9.8|0.408
72560153|NCT01513239|144650959|SUPERIORITY_OR_OTHER||Difference in Percentages|-2.3||||0.517|TWO_SIDED|95.0|-9.2|4.6|||Miettinen and Nurminen||MK-6072 + SOC minus Placebo + SOC|||4.6|-9.2|0.517
72443798|NCT04093752|144401242|SUPERIORITY||LS Mean Difference|-0.22||||0.184|TWO_SIDED|95.0|-0.55|0.11|||ANCOVA|||Hypoglycemia||0.11|-0.55|0.184
72443799|NCT04093752|144401242|SUPERIORITY||LS Mean Difference|1.81|||<|0.001|TWO_SIDED|95.0|1.03|2.59|||ANCOVA|||Treatment Satisfaction Score||2.59|1.03|<0.001
72560154|NCT01513239|144650960|SUPERIORITY_OR_OTHER||Difference in Percentages|-0.2||||0.931|TWO_SIDED|95.0|-3.8|3.5|||Miettinen and Nurminen||MK-3415A + SOC minus Placebo + SOC|||3.5|-3.8|0.931
72443800|NCT04093752|144401242|SUPERIORITY||LS Mean Difference|1.63|||<|0.001|TWO_SIDED|95.0|0.84|2.41|||ANCOVA|||Treatment Satisfaction Score||2.41|0.84|<0.001
72443801|NCT04093752|144401242|SUPERIORITY||LS Mean Difference|1.68|||<|0.001|TWO_SIDED|95.0|0.89|2.47|||ANCOVA|||Treatment Satisfaction Score||2.47|0.89|<0.001
72443802|NCT01101451|144401244|SUPERIORITY||Hazard Ratio (HR)|0.6976||||0.0927|TWO_SIDED|95.0|0.408|1.192||the pre\_specified nominal significance level was 0.0451 (one sided).|Log Rank||The RFS hazard ratio estimate is for reporting group 2 vs reporting group 1.|||1.192|0.408|0.0927
72443803|NCT01101451|144401245|SUPERIORITY||Hazard Ratio (HR)|0.586|||||TWO_SIDED|95.0|0.286|1.199|||||The OS hazard ratio estimate is for reporting group 2 vs reporting group 1.|||1.199|0.286|
72443804|NCT04157348|144401252|SUPERIORITY||Difference in remission rates|0.0121||||0.8773|TWO_SIDED|95.0|-0.1411|0.1653|||Regression, Logistic|marginal standardization method|The difference of remission rates (Benralizumab - Mepolizumab) are estimated using marginal standardization method in a logistic regression model. The covariates include treatment arm, baseline dose of prednisone, baseline BVAS and region.|||0.1653|-0.1411|0.8773
72443805|NCT04157348|144401253|SUPERIORITY||difference in remission rates|0.0544|||||TWO_SIDED|95.0|-0.0746|0.1834|||Regression, Logistic|marginal standardization method||||0.1834|-0.0746|
72443806|NCT04157348|144401254|SUPERIORITY||Odds Ratio (OR)|1.32|||||TWO_SIDED|95.0|0.72|2.4|||Proportional Odds Model||The odds ratio (Benralizumab vs. Mepolizumab) and its 95% CI are estimated with a proportional odds model. The covariates include treatment arm, baseline dose of prednisone, baseline BVAS and region. A \>1 odds ratio means Benralizumab is favored.|main remission||2.40|0.72|
72443807|NCT04157348|144401254|SUPERIORITY||Odds Ratio (OR)|1.12|||||TWO_SIDED|95.0|0.55|2.29|||Proportional Odds Model||The odds ratio (Benralizumab vs. Mepolizumab) and its 95% CI are estimated with a proportional odds model. The covariates include treatment arm, baseline dose of prednisone, baseline BVAS and region. A \>1 odds ratio means Benralizumab is favored.|supportive remission||2.29|0.55|
72560155|NCT01513239|144650960|SUPERIORITY_OR_OTHER||Difference in Percentages|0.0||||0.997|TWO_SIDED|95.0|-3.7|3.6|||Miettinen and Nurminen||MK-6072 + SOC minus Placebo + SOC|||3.6|-3.7|0.997
72443808|NCT04157348|144401255|SUPERIORITY||Odds Ratio (OR)|1.34|||||TWO_SIDED|95.0|0.74|2.44|||Proportional Odds Model||The odds ratio (Benralizumab vs. Mepolizumab) and its 95% CI are estimated with a proportional odds model. The covariates include treatment arm, baseline dose of prednisone, baseline BVAS and region.|sustained main remission||2.44|0.74|
72443809|NCT04157348|144401255|SUPERIORITY||Odds Ratio (OR)|1.23|||||TWO_SIDED|95.0|0.64|2.34|||Proportional Odds Model||The odds ratio (Benralizumab vs. Mepolizumab) and its 95% CI are estimated with a proportional odds model. The covariates include treatment arm, baseline dose of prednisone, baseline BVAS and region. A \>1 odds ratio means Benralizumab is favored.|sustained supportive remission||2.34|0.64|
72443810|NCT04157348|144401256|SUPERIORITY||Hazard Ratio (HR)|0.98|||||TWO_SIDED|95.0|0.53|1.82|||Regression, Cox||The HR (Benralizumab vs. Mepolizumab) and 95% CI are estimated using a Cox regression model with Efron method to control for ties. The covariates include treatment arm, baseline dose of prednisone, baseline BVAS and region.|relapse||1.82|0.53|
72443811|NCT04157348|144401257|SUPERIORITY||Risk Ratio (RR)|1.03|||||TWO_SIDED|95.0|0.56|1.9|||negative binomial model|marginal standardization method|The rate ratio (Benralizumab/Mepolizumab) and the corresponding 95% CI are calculated using a negative binomial model. The covariates in the model include treatment arm, baseline dose of prednisone, baseline BVAS and region.|relapse||1.90|0.56|
72443812|NCT04157348|144401259|SUPERIORITY||Odds Ratio (OR)|1.38|||||TWO_SIDED|95.0|0.75|2.54|||proportional odds model||The odds ratio (Benralizumab 30 mg vs. Mepolizumab 300 mg) and 95% CI are estimated using a proportional odds model. The covariates in the model include treatment arm, baseline dose of prednisone, baseline BVAS and region.|||2.54|0.75|
72560156|NCT01513239|144650961|SUPERIORITY_OR_OTHER||Difference in Percentages|0.5||||0.328|TWO_SIDED|95.0|-0.8|2.0|||Miettinen and Nurminen||MK-3415A + SOC minus Placebo + SOC|||2.0|-0.8|0.328
72560157|NCT01513239|144650961|SUPERIORITY_OR_OTHER||Difference in Percentages|-0.3||||0.308|TWO_SIDED|95.0|-1.5|0.7|||Miettinen and Nurminen||MK-6072 + SOC minus Placebo + SOC|||0.7|-1.5|0.308
72560158|NCT01513239|144650962|SUPERIORITY_OR_OTHER||Difference in Percentages|0.0|||>|0.999|TWO_SIDED|95.0|-1.0|1.0|||Miettinen and Nurminen||MK-3415A + SOC minus Placebo + SOC|||1.0|-1.0|>0.999
72443813|NCT04157348|144401260|SUPERIORITY||Odds Ratio (OR)|1.76|||||TWO_SIDED|95.0|0.96|3.22|||proportional odds model||The odds ratio (Benralizumab 30 mg vs. Mepolizumab 300 mg) for higher % reduction and 95% CI are estimated using a proportional odds model. The covariates in the model include treatment arm, baseline dose of prednisone, baseline BVAS and region.|||3.22|0.96|
72497094|NCT05384041|144524058|SUPERIORITY|||||||0.351|||||||Regression, Linear|||Difference (Active-Control) at Week 1||||0.351
72497095|NCT05384041|144524058|SUPERIORITY|||||||0.053|||||||Regression, Linear|||Difference (Active-Control) at Week 2||||0.053
72497096|NCT05384041|144524058|SUPERIORITY|||||||0.12|||||||Regression, Linear|||Difference (Active-Control) at Week 2||||0.120
72497097|NCT05384041|144524058|SUPERIORITY|||||||0.17|||||||Regression, Linear|||Difference (Active-Control) at Week 4||||0.170
72497098|NCT05384041|144524058|SUPERIORITY|||||||0.122|||||||Regression, Linear|||Difference (Active-Control) at Week 4||||0.122
72497099|NCT05384041|144524059|SUPERIORITY|||||||0.044|||||||Regression, Linear|||Difference (Active-Control) at Week 1||||0.044
72497100|NCT05384041|144524059|SUPERIORITY|||||||0.751|||||||Regression, Linear|||Difference (Active-Control) at Week 1||||0.751
72560159|NCT01513239|144650962|SUPERIORITY_OR_OTHER||Difference in Percentages|0.0|||>|0.999|TWO_SIDED|95.0|-1.0|1.0|||Miettinen and Nurminen||MK-6072 + SOC minus Placebo + SOC|||1.0|-1.0|>0.999
72443814|NCT04157348|144401261|SUPERIORITY||difference in proportions|0.1079|||||TWO_SIDED|95.0|-0.0225|0.2383|||Regression, Logistic|marginal standardization method|The difference of proportions (Benralizumab - Mepolizumab) and 95% CI are estimated using marginal standardization method in a logistic regression model. The covariates include treatment arm, baseline dose of prednisone, baseline BVAS and region.|\>=50% reduction||0.2383|-0.0225|
72443815|NCT04157348|144401261|SUPERIORITY||difference in proportions|0.1569|||||TWO_SIDED|95.0|0.0067|0.3017|||Regression, Logistic|marginal standardization method|The difference of proportions (Benralizumab - Mepolizumab) and 95% CI are estimated using marginal standardization method in a logistic regression model. The covariates include treatment arm, baseline dose of prednisone, baseline BVAS and region.|100% reduction||0.3017|0.0067|
72443816|NCT04157348|144401261|SUPERIORITY||difference in proportions|-0.0068|||||TWO_SIDED|95.0|-0.1555|0.1418|||Regression, Logistic|marginal standardization method|The difference of proportions (Benralizumab - Mepolizumab) and 95% CI are estimated using marginal standardization method in a logistic regression model. The covariates include treatment arm, baseline dose of prednisone, baseline BVAS and region.|OCS dose \<=4 mg/day||0.1418|-0.1555|
72443817|NCT04157348|144401262|SUPERIORITY||difference in response rates|0.046|||||TWO_SIDED|95.0|-0.0422|0.1341|||Regression, Logistic|marginal standardization method|The difference of response rates (Benralizumab - Mepolizumab) and 95% CI are estimated using marginal standardization method in a logistic regression model. The covariates include treatment arm, baseline dose of prednisone, baseline BVAS and region.|any clinical response-definition 1||0.1341|-0.0422|
72560160|NCT01513239|144650963|SUPERIORITY_OR_OTHER||Difference in Percentages|-0.4|||||TWO_SIDED|95.0|-4.2|3.3|||||MK-3415A + SOC minus Placebo + SOC|||3.3|-4.2|
72560161|NCT01513239|144650963|SUPERIORITY_OR_OTHER||Difference in Percentages|1.2|||||TWO_SIDED|95.0|-2.7|5.2|||||MK-6072 + SOC minus Placebo + SOC|||5.2|-2.7|
72560162|NCT00059332|144650986|SUPERIORITY_OR_OTHER|||||||0.28|ONE_SIDED||||||Cochran-Mantel-Haenszel|||For the primary efficacy analysis, data were analyzed to test the null hypothesis that the distribution of scores over all 7 levels of the modified Rankin Scale at Day 90 was identical in the magnesium sulfate and placebo groups, vs. the one-sided alternative that the distribution of scores is shifted lower in the active magnesium sulfate therapy group. The statistic used to test the primary hypothesis was the Cochran-Mantel-Haenszel test statistic stratified by transport vehicle.||||0.28
72560163|NCT00059332|144650987|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.98||||0.87|TWO_SIDED|95.0|0.81|1.2|||Chi-squared|||||1.20|0.81|0.87
72443818|NCT04157348|144401262|SUPERIORITY||difference in response rates|0.079|||||TWO_SIDED|95.0|-0.0732|0.2312|||Regression, Logistic|marginal standardization method|The difference of response rates (Benralizumab - Mepolizumab) and 95% CI are estimated using marginal standardization method in a logistic regression model. The covariates include treatment arm, baseline dose of prednisone, baseline BVAS and region.|complete response-definition 1||0.2312|-0.0732|
72497101|NCT05384041|144524059|SUPERIORITY|||||||0.013|||||||Regression, Linear|||Difference (Active-Control) at Week 2||||0.013
72497102|NCT05384041|144524059|SUPERIORITY|||||||0.318|||||||Regression, Linear|||Difference (Active-Control) at Week 2||||0.318
72497103|NCT05384041|144524059|SUPERIORITY|||||||0.173|||||||Regression, Linear|||Difference (Active-Control) at Week 4||||0.173
72497104|NCT05384041|144524059|SUPERIORITY|||||||0.142|||||||Regression, Linear|||Difference (Active-Control) at Week 4||||0.142
72497105|NCT05384041|144524060|SUPERIORITY|||||||0.026|||||||Chi-squared|||Difference (Active-Control) at Week 1||||0.026
72497106|NCT05384041|144524060|SUPERIORITY|||||||0.241|||||||Chi-squared|||Difference (Active-Control) at Week 1||||0.241
72497107|NCT05384041|144524060|SUPERIORITY|||||||0.059|||||||Chi-squared|||Difference (Active-Control) at Week 2||||0.059
72497108|NCT05384041|144524060|SUPERIORITY|||||||0.478|||||||Chi-squared|||Difference (Active-Control) at Week 2||||0.478
72497109|NCT05384041|144524060|SUPERIORITY|||||||0.009|||||||Chi-squared|||Difference (Active-Control) at Week 4||||0.009
72497110|NCT05384041|144524060|SUPERIORITY|||||||0.729|||||||Chi-squared|||Difference (Active-Control) at Week 4||||0.729
72497111|NCT05384041|144524061|SUPERIORITY|||||||0.044|||||||Chi-squared|||Difference (Active-Control) at Week 1||||0.044
72497112|NCT05384041|144524061|SUPERIORITY|||||||0.067|||||||Chi-squared|||Difference (Active-Control) at Week 2||||0.067
72497113|NCT05384041|144524061|SUPERIORITY|||||||0.016|||||||Chi-squared|||Difference (Active-Control) at Week 4||||0.016
72497114|NCT05384041|144524061|SUPERIORITY|||||||0.006|||||||Chi-squared|||Difference (Active-Control) at Week 1||||0.006
72497115|NCT05384041|144524061|SUPERIORITY|||||||0.036|||||||Chi-squared|||Difference (Active-Control) at Week 2||||0.036
72497116|NCT05384041|144524061|SUPERIORITY|||||||0.016|||||||Chi-squared|||Difference (Active-Control) at Week 4||||0.016
72497117|NCT05384041|144524061|SUPERIORITY|||||||0.914|||||||Chi-squared|||Difference (Active-Control) at Week 1||||0.914
72497118|NCT05384041|144524061|SUPERIORITY|||||||0.887|||||||Chi-squared|||Difference (Active-Control) at Week 2||||0.887
72497119|NCT05384041|144524061|SUPERIORITY|||||||0.791|||||||Chi-squared|||Difference (Active-Control) at Week 4||||0.791
72497120|NCT02086331|144524062|OTHER||||||||||||||||||Intraclass correlation of repeated measures - 0.96, p=0.08|||
72443819|NCT04157348|144401263|SUPERIORITY||difference in remission rates|0.0554|||||TWO_SIDED|95.0|-0.093|0.2037|||Regression, Logistic|marginal standardization method|The difference of remission rates (Benralizumab - Mepolizumab) and 95% CI are estimated using marginal standardization method in a logistic regression model. The covariates include treatment arm, baseline dose of prednisone, baseline BVAS and region.|main remission||0.2037|-0.0930|
72443820|NCT04157348|144401263|SUPERIORITY||difference in remission rates|0.0467|||||TWO_SIDED|95.0|-0.1021|0.1956|||Regression, Logistic|marginal standardization method|The difference of remission rates (Benralizumab - Mepolizumab) and 95% CI are estimated using marginal standardization method in a logistic regression model. The covariates include treatment arm, baseline dose of prednisone, baseline BVAS and region.|supportive remission||0.1956|-0.1021|
72443821|NCT04757610|144401288|SUPERIORITY||Least Squares Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|1.023||0.284421|TWO_SIDED|95.0|-3.1|0.91|||MMRM|||||0.91|-3.10|0.284421
72443822|NCT04757610|144401288|SUPERIORITY||Least Squares Mean Difference|-1.88|STANDARD_ERROR_OF_MEAN|1.025||0.066678|TWO_SIDED|95.0|-3.9|0.13|||MMRM|||||0.13|-3.90|0.066678
72443823|NCT04154384|144401303|SUPERIORITY|A comparison of the proportion of participants in each arm reporting an improvement in average pain score on the Numeric Rating Scale from baseline to 3 months follow-up.||||||0.035||||||A comparison of the proportion of participants in each arm reporting an improvement in average pain score on the Numeric Rating Scale from baseline to 12 weeks follow-up.|Chi-squared|||||||0.035
72443824|NCT05048186|144401315|OTHER||Mean Difference (Final Values)|0.06||||0.503|TWO_SIDED|95.0|-0.116|0.236|||t-test, 2 sided|||we tested to see whether SDM Process scores were different between patients who received the Decision Aid Arm vs the control arm||0.236|-0.116|0.503
72443825|NCT04218266|144401338|OTHER||Crude incidence ratio|0.42|||||TWO_SIDED|90.0|0.26|0.67||||||Comparison of the Asundexian pooled group (Asundexian 20 mg group and Asundexian 50 mg group) versus Apixaban group in all bleeding||0.67|0.26|
72443826|NCT04218266|144401340|OTHER||Crude incidence ratio|0.33|||||TWO_SIDED|90.0|0.09|0.97||||||Comparison of the Asundexian pooled group (Asundexian 20 mg group and Asundexian 50 mg group) versus Apixaban group in ISTH CRNM bleeding||0.97|0.09|
72443827|NCT04218266|144401341|OTHER||Crude incidence ratio|0.47|||||TWO_SIDED|90.0|0.28|0.83||||||Comparison of the Asundexian pooled group (Asundexian 20 mg group and Asundexian 50 mg group) versus Apixaban group in ISTH minor bleeding||0.83|0.28|
72443828|NCT04218266|144401342|OTHER||Crude incidence ratio|0.33|||||TWO_SIDED|90.0|0.09|0.97|||Other|||Comparison of the Asundexian pooled group (Asundexian 20 mg group and Asundexian 50 mg group) versus Apixaban group in ISTH major bleeding or CRNM bleeding||0.97|0.09|
72443829|NCT02742519|144401343|SUPERIORITY|||||||0.2121|||||||t-test, 2 sided|||||||0.2121
72443830|NCT02119650|144401363|OTHER||Hazard Ratio (HR)|0.877||||0.7562|TWO_SIDED|80.0|0.509|1.51|||Log Rank|The 2-sided p-value was calculated based on the log-rank test and stratified by modified Glasgow Prognostic Score (mGPS).||||1.51|0.509|0.7562
72443831|NCT02349412|144401425|SUPERIORITY||Mean Difference (Final Values)|3.23||||0.104|TWO_SIDED|95.0|-0.67|7.13|||ANCOVA|Statistical Method: Available Case ANCOVA Model adjusting for baseline FACT-G score||||7.13|-0.67|0.104
72443832|NCT02349412|144401426|SUPERIORITY||Mean Difference (Final Values)|3.12||||0.188|TWO_SIDED|95.0|-1.54|7.77|||ANCOVA|Statistical Method: Available Case ANCOVA Model adjusting for baseline FACT-G score||||7.77|-1.54|0.188
72443833|NCT02349412|144401427|SUPERIORITY||Mean Difference (Final Values)|0.08||||0.884|TWO_SIDED|95.0|-0.94|2.09|||ANCOVA|Statistical Method: Available Case ANCOVA Model adjusting for baseline HADS-Depression score||||2.09|-0.94|0.884
72443834|NCT02349412|144401428|SUPERIORITY||Mean Difference (Final Values)|-0.81||||0.033|TWO_SIDED|95.0|-1.54|-0.07|||ANCOVA|Statistical Method: Available Case ANCOVA Model adjusting for baseline HADS-Anxiety score||||-0.07|-1.54|0.033
72443835|NCT02349412|144401429|SUPERIORITY|||||||0.006|||||||Chi-squared|||||||0.006
72443836|NCT03611153|144401439|SUPERIORITY|||||||0.04|||||||ANCOVA|||||||0.040
72443837|NCT03611153|144401441|SUPERIORITY|||||||0.777|||||||t-test, 2 sided|||||||0.777
72443838|NCT03611153|144401442|SUPERIORITY|||||||0.805|||||||t-test, 2 sided|||Right atrial pressure||||0.805
72443839|NCT03611153|144401442|SUPERIORITY|||||||0.148|||||||t-test, 2 sided|||pulmonary artery systolic pressure||||0.148
72443840|NCT03611153|144401442|SUPERIORITY|||||||0.09|||||||t-test, 2 sided|||Mean pulmonary artery pressure||||0.090
72443841|NCT03611153|144401443|SUPERIORITY|||||||0.786|||||||t-test, 2 sided|||Right atrial pressure||||0.786
72443842|NCT03611153|144401443|SUPERIORITY|||||||0.796|||||||t-test, 2 sided|||Pulmonary artery systolic pressure||||0.796
72443843|NCT03611153|144401443|SUPERIORITY|||||||0.703|||||||t-test, 2 sided|||Mean pulmonary artery pressure||||0.703
72443844|NCT03611153|144401444|SUPERIORITY|||||||0.418|||||||t-test, 2 sided|||||||0.418
72443845|NCT03611153|144401445|SUPERIORITY|||||||0.669|||||||t-test, 2 sided|||||||0.669
72443846|NCT04840199|144401456|SUPERIORITY||Mean Difference (Net)|-0.031||||0.2|TWO_SIDED|95.0|-0.08|0.018||No adjustment for multiple comparisons|Regression, Linear||Treatment effect was estimated as the difference in mean change in log10 sTNFRII with randomized letermovir compared to no anti-CMV treatment from a linear regression model (0 reflects no difference between arms).|||0.018|-0.080|0.20
72443847|NCT04840199|144401457|SUPERIORITY||Risk Difference (RD)|0.172||||0.19|TWO_SIDED|95.0|-0.073|0.438||No adjustment for multiple comparisons|Chan/Zhang exact test diff. proportions||An exact 95% confidence interval around the observed difference in proportions (and the associated p-value) was constructed based on the standardized statistic and inverting two 1-sided tests (Chan-Zhang method).|||0.438|-0.073|0.19
72443848|NCT04840199|144401459|SUPERIORITY||Odds Ratio (OR)|0.91||||0.12|TWO_SIDED|95.0|0.8|1.03||No adjustment for multiple comparisons|GEE model for repeated binary outcomes|P-value is from the time and treatment group interaction in the early treatment phase.|Treatment effect was estimated as the odds ratio of weekly rate of change (slope) in odds of CMV DNA detection with randomized letermovir compared to no anti-CMV treatment from a GEE model with linear splines (1 reflects no difference between arms).|Early treatment phase comparison||1.03|0.80|0.12
72497121|NCT00510276|144524064|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.82||||0.005|TWO_SIDED|95.0|1.44|8.2||A gate-keeper strategy was applied to adjust for multiple tests.|Mixed Models Analysis|||Tested was the null hypothesis that there is no statistically significant difference in AAQOL-29 score changes from baseline to 12-week endpoint between atomoxetine and placebo treatment groups.||8.20|1.44|0.005
72560164|NCT00059332|144650988|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.98||||0.87|TWO_SIDED|95.0|0.81|1.19|||Chi-squared|||||1.19|0.81|0.87
72560165|NCT00059332|144650989|SUPERIORITY_OR_OTHER|||||||0.276|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.2760
72560166|NCT00059332|144650990|SUPERIORITY_OR_OTHER|||||||0.3912|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.3912
72560167|NCT00059332|144650991|SUPERIORITY_OR_OTHER|||||||0.323|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.3230
72560168|NCT00059332|144650992|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.05||||0.95|TWO_SIDED|95.0|0.87|1.27|||Chi-squared|||||1.27|0.87|0.95
72443849|NCT04840199|144401459|SUPERIORITY||Odds Ratio (OR)|0.92||||0.009|TWO_SIDED|95.0|0.87|0.98||No adjustment for multiple comparisons|GEE model for repeated binary outcomes|P-value is from the time and treatment group interaction in the late treatment phase.|Treatment effect was estimated as the odds ratio of weekly rate of change (slope) in odds of CMV DNA detection with randomized letermovir compared to no anti-CMV treatment from a GEE model with linear splines (1 reflects no difference between arms).|Late treatment phase comparison||0.98|0.87|0.009
72443850|NCT04840199|144401459|SUPERIORITY||Odds Ratio (OR)|1.17||||0.24|TWO_SIDED|95.0|0.9|1.53||No adjustment for multiple comparisons|GEE model for repeated binary outcomes|P-value is from the time and treatment group interaction in the post treatment phase.|Treatment effect was estimated as the odds ratio of weekly rate of change (slope) in odds of CMV DNA detection with randomized letermovir compared to no anti-CMV treatment from a GEE model with linear splines (1 reflects no difference between arms).|Post treatment phase comparison||1.53|0.90|0.24
72443851|NCT04840199|144401462|SUPERIORITY||Mean Difference (Net)|0.0002||||0.95|TWO_SIDED|95.0|-0.0062|0.0066||No adjustment for multiple comparisons|GEE model for repeated outcomes|P-value is from the time and treatment group interaction in the early treatment phase.|Treatment effect was estimated as the difference in weekly rate of change (slope) in log10 sCD163 with randomized letermovir compared to no anti-CMV treatment from a GEE model with linear splines (1 reflects no difference between treatment groups).|Early treatment phase comparison||0.0066|-0.0062|0.95
72443852|NCT04840199|144401462|SUPERIORITY||Mean Difference (Net)|-0.0007||||0.28|TWO_SIDED|95.0|-0.0019|0.0005||No adjustment for multiple comparisons|GEE model for repeated outcomes|P-value is from the time and treatment group interaction in the late treatment phase.|Treatment effect was estimated as the difference in weekly rate of change (slope) in log10 sCD163 with randomized letermovir compared to no anti-CMV treatment from a GEE model with linear splines (1 reflects no difference between treatment groups).|Late treatment phase comparison||0.0005|-0.0019|0.28
72443853|NCT04840199|144401462|SUPERIORITY||Mean Difference (Net)|0.0056||||0.077|TWO_SIDED|95.0|-0.0006|0.0118||No adjustment for multiple comparisons|GEE model for repeated outcomes|P-value is from the time and treatment group interaction in the post treatment phase.|Treatment effect was estimated as the difference in weekly rate of change (slope) in log10 sCD163 with randomized letermovir compared to no anti-CMV treatment from a GEE model with linear splines (1 reflects no difference between treatment groups).|Post treatment phase comparison||0.0118|-0.0006|0.077
72443854|NCT04840199|144401463|SUPERIORITY||Mean Difference (Net)|0.0009||||0.72|TWO_SIDED|95.0|-0.004|0.0058||No adjustment for multiple comparisons|GEE model for repeated outcomes|P-value is from the time and treatment group interaction in the early treatment phase.|Treatment effect was estimated as the difference in weekly rate of change (slope) in log10 sTNFRII with randomized letermovir compared to no anti-CMV treatment from a GEE model with linear splines (1 reflects no difference between arms).|Early treatment phase comparison||0.0058|-0.0040|0.72
72443855|NCT04840199|144401463|SUPERIORITY||Mean Difference (Net)|-0.0009||||0.13|TWO_SIDED|95.0|-0.0022|0.0003||No adjustment for multiple comparisons|GEE model for repeated outcomes|P-value is from the time and treatment group interaction in the late treatment phase.|Treatment effect was estimated as the difference in weekly rate of change (slope) in log10 sTNFRII with randomized letermovir compared to no anti-CMV treatment from a GEE model with linear splines (1 reflects no difference between arms).|Late treatment phase comparison||0.0003|-0.0022|0.13
72443856|NCT04840199|144401463|SUPERIORITY||Mean Difference (Net)|0.0023||||0.17|TWO_SIDED|95.0|-0.001|0.0055||No adjustment for multiple comparisons|GEE model for repeated outcomes|P-value is from the time and treatment group interaction in the post treatment phase.|Treatment effect was estimated as the difference in weekly rate of change (slope) in log10 sTNFRII with randomized letermovir compared to no anti-CMV treatment from a GEE model with linear splines (1 reflects no difference between arms).|Post treatment phase comparison||0.0055|-0.0010|0.17
72443857|NCT05215847|144401465|OTHER|Adverse event subject incidence and event frequency.|||||||||||||||||Adverse event subject incidence and event frequency.|||
72443858|NCT04761302|144401503|SUPERIORITY|||||||0.215||||||A priori threshold for statistical significance: \<0.05|t-test, 2 sided|||||||0.215
72443859|NCT04761302|144401503|SUPERIORITY|||||||0.445||||||A priori threshold for statistical significance: \<0.05|t-test, 2 sided|||||||0.445
72443860|NCT04761302|144401504|SUPERIORITY|||||||0.041||||||A priori threshold for statistical significance: \<0.05|t-test, 2 sided|||||||0.041
72443861|NCT04761302|144401504|SUPERIORITY|||||||0.3||||||A priori threshold for statistical significance: \<0.05|t-test, 2 sided|||||||0.300
72443862|NCT04761302|144401505|SUPERIORITY|||||||0.12||||||A priori threshold for statistical significance: \<0.05|t-test, 2 sided|||||||0.12
72443863|NCT04761302|144401505|SUPERIORITY|||||||0.359||||||A priori threshold for statistical significance: \<0.05|t-test, 2 sided|||||||0.359
72443864|NCT04761302|144401506|SUPERIORITY|||||||0.083||||||A priori threshold for statistical significance: \<0.05|t-test, 2 sided|||||||0.083
72560169|NCT00059332|144650993|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.62||||0.12|TWO_SIDED|95.0|0.34|1.14|||Chi-squared|||||1.14|0.34|0.12
72443865|NCT04761302|144401506|SUPERIORITY|||||||0.152||||||A priori threshold for statistical significance: \<0.05|t-test, 2 sided|||||||0.152
72560170|NCT00059332|144650994|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.99||||0.95|TWO_SIDED|95.0|0.76|1.29|||Chi-squared|||||1.29|0.76|0.95
72560171|NCT01721772|144651068|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.42|||<|0.0001|TWO_SIDED|95.0|0.3|0.6|||Stratified Log Rank Test|||||0.60|0.30|<0.0001
72560172|NCT01721772|144651069|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.44|||<|0.0001|TWO_SIDED|95.0|0.34|0.56|||Stratified Log Rank Test|||||0.56|0.34|<0.0001
72560173|NCT01721772|144651071|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|4.43|||<|0.0001|TWO_SIDED|95.0|2.75|7.13|||Cochran-Mantel-Haenszel|||||7.13|2.75|<0.0001
72497122|NCT00510276|144524065|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.9||||0.006|TWO_SIDED|95.0|1.68|10.12||A gate-keeper strategy was applied to adjust for multiple tests.|Mixed Models Analysis|||Tested was the null hypothesis that there is no statistically significant difference in AAQOL-29 relationship subscale score changes from baseline to 12-week endpoint between atomoxetine and placebo treatment groups.||10.12|1.68|0.006
72497123|NCT00510276|144524066|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.73||||0.018|TWO_SIDED|95.0|1.0|10.46||A gate-keeper strategy was applied to adjust for multiple tests.|Mixed Models Analysis|||Tested was the null hypothesis that there is no statistically significant difference in AAQOL-29 relationship subscale score changes from baseline to 12-week endpoint between atomoxetine and placebo treatment groups.||10.46|1.00|0.018
72497124|NCT00510276|144524067|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.36||||0.034|TWO_SIDED|95.0|0.33|8.39||A gate-keeper strategy was applied to adjust for multiple tests.|Mixed Models Analysis|||Tested was the null hypothesis that there is no statistically significant difference in AAQOL-29 psychological health subscale score changes from baseline to 12-week endpoint between atomoxetine and placebo treatment groups.||8.39|0.33|0.034
72497125|NCT00510276|144524068|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.4||||0.074|TWO_SIDED|95.0|-0.33|7.12||A gate-keeper strategy was applied to adjust for multiple tests.|ANCOVA|||Tested was the null hypothesis that there is no statistically significant difference in AAQOL-29 life outlook subscale score changes from baseline to 12-week endpoint between atomoxetine and placebo treatment groups.||7.12|-0.33|0.074
72497126|NCT00510276|144524069|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.43|||<|0.001|TWO_SIDED|95.0|-0.63|-0.24|||ANCOVA|ANCOVA with terms for baseline score, treatment, and investigator.||Tested was the null hypothesis that there is no statistically significant difference in CGI-ADHD-S score changes from baseline to 12-week endpoint between atomoxetine and placebo treatment groups.||-0.24|-0.63|<0.001
72497127|NCT00510276|144524070|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.04|||<|0.001|TWO_SIDED|95.0|-5.94|-2.15|||Mixed Models Analysis|||Tested was the null hypothesis that there is no statistically significant difference in CAARS-S:SV score changes from baseline to 12-week endpoint between atomoxetine and placebo treatment groups.||-2.15|-5.94|<0.001
72497128|NCT00510276|144524071|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.25||||0.02|TWO_SIDED|95.0|-0.45|-0.04|||ANCOVA|ANCOVA with terms for baseline score, treatment, and investigator.||Tested was the null hypothesis that there is no statistically significant difference in PGI-I scores at 12-week endpoint between atomoxetine and placebo treatment groups.||-0.04|-0.45|0.020
72497129|NCT00510276|144524072|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.42||||0.282|TWO_SIDED|95.0|-1.19|0.35|||ANCOVA|ANCOVA model with terms for baseline score, treatment, and investigator.||Tested was the null hypothesis that there is no statistically significant difference in MADRS score changes from baseline to 12-week endpoint between atomoxetine and placebo treatment groups.||0.35|-1.19|0.282
72497130|NCT00510276|144524073|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.51||||0.556|TWO_SIDED|95.0|-2.21|1.19|||ANCOVA|ANCOVA model with terms for baseline score, treatment, and investigator.||Tested was the null hypothesis that there is no statistically significant difference in BAI score changes from baseline to 12-week endpoint between atomoxetine and placebo treatment groups.||1.19|-2.21|0.556
72497131|NCT00510276|144524074|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Pearson's Correlation Coefficient|||Tested was the null hypothesis that AAQOL-29 total score and CAARS-Inv:SV total score are not correlated.||||<0.001
72497132|NCT00510276|144524075|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.15||||0.198|TWO_SIDED|95.0|-0.39|0.08|||ANCOVA|ANCOVA model with terms for baseline score, treatment, and investigator.||Tested was the null hypothesis that there is no statistically significant difference in TLFB incidence for use of alcohol score changes from baseline to 12-week endpoint between atomoxetine and placebo treatment groups.||0.08|-0.39|0.198
72497133|NCT00510276|144524076|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.03||||0.825|TWO_SIDED|95.0|-0.33|0.26|||ANCOVA|ANCOVA model with terms for baseline score, treatment, and investigator.||Tested was the null hypothesis that there is no statistically significant difference in TLFB incidence for use of caffeine score changes from baseline to 12-week endpoint between atomoxetine and placebo treatment groups.||0.26|-0.33|0.825
72497134|NCT00510276|144524078|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.82||||0.233|TWO_SIDED|95.0|-0.53|2.17|||ANCOVA|ANCOVA model with terms for baseline score, treatment, and investigator.||Tested was the null hypothesis that there is no statistically significant difference in TLFB incidence for use of nicotine score changes from baseline to 12-week endpoint between atomoxetine and placebo treatment groups.||2.17|-0.53|0.233
72560174|NCT01721772|144651072|SUPERIORITY_OR_OTHER_LEGACY||Unstratified Hazard Ratio|0.37|||||TWO_SIDED|95.0|0.24|0.56|||||PD-L1 positive group|||0.56|0.24|
72560175|NCT01721772|144651072|SUPERIORITY_OR_OTHER_LEGACY||Unstratified Hazard Ratio|0.6|||||TWO_SIDED|95.0|0.45|0.8|||||PD-L1 negative group|||0.80|0.45|
72560176|NCT01721772|144651075|SUPERIORITY||Hazard Ratio (HR)|0.51|||||TWO_SIDED|95.0|0.41|0.65||||||||0.65|0.41|
72560177|NCT02542462|144651083|SUPERIORITY|||||||0.2||||||P value for the number of subjects with an increase of 1 mm or more of terminal ileum from pre to post was 0.2|Fisher Exact|||The test is to see a difference among the four groups and the pre to post change of the primary outcomes||||0.2
72560178|NCT02542462|144651083|SUPERIORITY|||||||0.3||||||P value for change in the number of subjects with an increase in number of lymph nodes from pre to post was 0.3.|Fisher Exact|||The test is to see a difference among the four groups and the pre to post change of the primary outcomes||||0.3
72560179|NCT05004649|144651106|OTHER|||||||0.024356||||||When Bonferroni corrected for multiple comparisons the significance level across conditions is p \< 0.0167. This is the Bonferonni corrected level for three tests applied to a baseline significance value of 0.05.|t-test, 2 sided|||||||.024356
72389007|NCT01817530|144286171|SUPERIORITY|||||||0.004||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Final Visit||||0.004
72560180|NCT05004649|144651106|OTHER|||||||0.040382||||||When Bonferroni corrected for multiple comparisons the significance level across conditions is p \< 0.0167. This is the Bonferonni corrected level for three tests applied to a baseline significance value of 0.05.|t-test, 2 sided|||||||.040382
72443866|NCT04761302|144401507|SUPERIORITY|||||||0.002||||||A priori threshold for statistical significance: \<0.05|t-test, 2 sided|||||||0.002
72443867|NCT04761302|144401507|SUPERIORITY||||||<|0.001||||||A priori threshold for statistical significance: \<0.05|t-test, 2 sided|||||||<0.001
72443868|NCT04761302|144401508|SUPERIORITY|||||||0.002||||||A priori threshold for statistical significance: \<0.05|t-test, 2 sided|||||||0.002
72443869|NCT04761302|144401508|SUPERIORITY||||||<|0.001||||||A priori threshold for statistical significance: \<0.05|t-test, 2 sided|||||||<0.001
72443870|NCT04761302|144401509|SUPERIORITY|||||||0.004||||||A priori threshold for statistical significance: \<0.05|t-test, 2 sided|||||||0.004
72443871|NCT04761302|144401509|SUPERIORITY||||||<|0.001||||||A priori threshold for statistical significance: \<0.05|t-test, 2 sided|||||||<0.001
72443872|NCT04761302|144401510|SUPERIORITY|||||||0.006||||||A priori threshold for statistical significance: \<0.05|t-test, 2 sided|||||||0.006
72443873|NCT04761302|144401510|SUPERIORITY||||||<|0.001||||||A priori threshold for statistical significance: \<0.05|t-test, 2 sided|||||||<0.001
72443874|NCT04761302|144401511|SUPERIORITY|||||||0.354||||||A priori threshold for statistical significance: \<0.05|t-test, 2 sided|||||||0.354
72443875|NCT04761302|144401511|SUPERIORITY|||||||0.455||||||A priori threshold for statistical significance: \<0.05|t-test, 2 sided|||||||0.455
72443876|NCT02728557|144401512|OTHER|MLM models||||||0.016|||||||MLM|MLM||A model with two three-way interactions of time by treatment condition by attachment orientation (Time Å\~ Treatment condition Å\~ Attachment anxiety, Time Å\~ Treatment condition Å\~ Attachment avoidance) along the lower-level effects to predict differences in the slope of change in outcome. The threshold for statistical significance was p\>0.05.||||.016
72443877|NCT03897686|144401518|SUPERIORITY|\[Not specified\]|LS-means difference|-179.3|STANDARD_ERROR_OF_MEAN|48.38||0.0003|TWO_SIDED|95.0|-274.96|-83.65||The threshold for statistical significance was p \<0.05.|ANCOVA|"Analysis of covariance (ANCOVA) adjusted for the baseline value with fixed factors of treatment group and radiological stage"||"It was determined that 144 participants randomized into 2 groups (1:1) would have at least 80% power to detect an effect size of 0.25. Sample size was calculated based on analysis of covariance adjusted for baseline value with fixed factors of group assuming α = 0.05 and 10% discontinuation rate.~The null hypothesis states that there is no difference between treatment groups in mean change from baseline to Week 25 in the total WOMAC score."||-83.65|-274.96|0.00030
72443878|NCT03897686|144401518|SUPERIORITY|\[Not specified\]|LS-means difference|-179.3|STANDARD_ERROR_OF_MEAN|48.38||0.0017|TWO_SIDED|95.0|-305.11|-53.5||Difference between Least-square means was tested at a level of p \<0.05 via Tukey's multiple comparison test|Tukey's HSD|||"After the analysis of covariance were performed pairwise comparisons of NOLTREX and placebo groups for each stage of OA:~1\) Group A (NOLTREX™) OA grade II versus Group B (Placebo) ОА grade II"||-53.50|-305.11|0.0017
72443879|NCT03897686|144401518|SUPERIORITY||LS-means difference|-37.01|STANDARD_ERROR_OF_MEAN|61.85||0.9324|TWO_SIDED|95.0|-197.83|123.82||Difference between Least-square means was tested at a level of p \<0.05 via Tukey's multiple comparison test|Tukey's HSD|||"After the analysis of covariance were performed pairwise comparisons of NOLTREX and placebo groups for each stage of OA:~2\) Group A (NOLTREX™) OA grade II versus Group A (NOLTREX™) ОА grade III"||123.82|-197.83|0.9324
72443880|NCT03897686|144401518|SUPERIORITY||LS-means difference|-216.31|STANDARD_ERROR_OF_MEAN|75.01||0.0233|TWO_SIDED|95.0|-411.37|-21.25||Difference between Least-square means was tested at a level of p \<0.05 via Tukey's multiple comparison test.|Tukey's HSD|||"After the analysis of covariance were performed pairwise comparisons of NOLTREX and placebo groups for each stage of OA:~3\) Group A (NOLTREX™) OA grade II versus Group B (Placebo) ОА grade III"||-21.25|-411.37|0.0233
72443881|NCT03897686|144401518|SUPERIORITY||LS-means difference|142.3|STANDARD_ERROR_OF_MEAN|81.89||0.3082|TWO_SIDED|95.0|-70.63|355.22||Difference between Least-square means was tested at a level of p \<0.05 via Tukey's multiple comparison test.|Tukey's HSD|||"After the analysis of covariance were performed pairwise comparisons of NOLTREX and placebo groups for each stage of OA:~4\) Group A (NOLTREX™) OA grade III versus Group B (Placebo) ОА grade II"||355.22|-70.63|0.3082
72443882|NCT03897686|144401518|SUPERIORITY||LS-means difference|-37.01|STANDARD_ERROR_OF_MEAN|61.85||0.9324|TWO_SIDED|95.0|-197.83|123.82||Difference between Least-square means was tested at a level of p \<0.05 via Tukey's multiple comparison test.|Tukey's HSD|||"After the analysis of covariance were performed pairwise comparisons of NOLTREX and placebo groups for each stage of OA:~5\) versus Group B (Placebo) OA grade II versus Group B (Placebo) ОА grade III"||123.82|-197.83|0.9324
72443883|NCT03897686|144401518|SUPERIORITY||Slope|-179.3|STANDARD_ERROR_OF_MEAN|48.38||0.0017|TWO_SIDED|95.0|-305.11|-53.5||Difference between Least-square means was tested at a level of p \<0.05 via Tukey's multiple comparison test.|Tukey's HSD|||"After the analysis of covariance were performed pairwise comparisons of NOLTREX and placebo groups for each stage of OA:~6\) Group A (NOLTREX™) OA grade III versus Group B (Placebo) ОА grade III"||-53.50|-305.11|0.0017
72443884|NCT03897686|144401519|SUPERIORITY|\[Not specified\]|S-means difference|-143.39|STANDARD_ERROR_OF_MEAN|46.88||0.00267|TWO_SIDED|95.0|-236.09|-50.69||The threshold for statistical significance was p \<0.05.|ANCOVA|"Analysis of covariance (ANCOVA) adjusted for the baseline value with fixed factors of treatment group and radiological stage"||It was determined that 144 participants randomized into 2 groups (1:1) would have at least 80% power to detect an effect size of 0.25. Sample size was calculated based on analysis of covariance adjusted for baseline value with fixed factors of group assuming α = 0.05 and 10% discontinuation rate.||-50.69|-236.09|0.00267
72443885|NCT03897686|144401520|SUPERIORITY||LS-means difference|-13.23|STANDARD_ERROR_OF_MEAN|9.995||0.16786|TWO_SIDED|95.0|-32.096|5.638||The threshold for statistical significance was p \<0.05.|ANCOVA|"Analysis of covariance (ANCOVA) adjusted for the baseline value with fixed factors of treatment group and radiological stage"||Contrasts for changes in pain WOMAC score at visit 3 (week 6)||5.638|-32.096|0.16786
72560181|NCT05004649|144651106|OTHER|||||||0.90161||||||When Bonferroni corrected for multiple comparisons the significance level across conditions is p \< 0.0167. This is the Bonferonni corrected level for three tests applied to a baseline significance value of 0.05.|t-test, 2 sided|||||||.90161
72497135|NCT00510276|144524079|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.06||||0.676|TWO_SIDED|95.0|-0.24|0.37|||ANCOVA|ANCOVA model with terms for baseline score, treatment, and investigator.||Tested was the null hypothesis that there is no statistically significant difference in TLFB incidence for use of marijuana score changes from baseline to 12-week endpoint between atomoxetine and placebo treatment groups.||0.37|-0.24|0.676
72497136|NCT00510276|144524080|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.31||||0.382|TWO_SIDED|95.0|-1.0|0.39|||ANCOVA|ANCOVA model with terms for baseline score, treatment, and investigator.||Tested was the null hypothesis that there is no statistically significant difference in Fagerstorm Test for Nicotine Dependence score changes from baseline to 12-week endpoint between atomoxetine and placebo treatment groups.||0.39|-1.00|0.382
72497137|NCT00510276|144524081|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.22||||0.656|TWO_SIDED|95.0|-1.24|0.78|||ANCOVA|ANCOVA model with terms for baseline score, treatment, and investigator.||Tested was the null hypothesis that there is no statistically significant difference in SASS score changes from baseline to 12-week endpoint between atomoxetine and placebo treatment groups.||0.78|-1.24|0.656
72497138|NCT00510276|144524082|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.61||||0.201|TWO_SIDED|95.0|-4.08|0.86|||ANCOVA|ANCOVA model with terms for baseline score, treatment, and investigator.||Tested was the null hypothesis that there is no statistically significant difference in Driving Behavior Survey Self-Report score changes from baseline to 12-week endpoint between atomoxetine and placebo treatment groups.||0.86|-4.08|0.201
72497139|NCT00510276|144524083|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.06|||<|0.001|TWO_SIDED|95.0|-7.39|-2.72|||Mixed Models Analysis|Adjusted for treatment, investigator, visit, treatment-by-visit interaction, baseline score, baseline score-by-visit interaction.||Tested was the null hypothesis that there is no difference in CAARS-Inv:SV score changes from baseline to 12-week endpoint between the atomoxetine group and the placebo group. With approximately 220 patients per arm, assuming a 68% completion rate and an estimated effect size of atomoxetine over placebo of 0.35, using a 5% significance level, the analysis was expected to have 90% power to detect a difference between atomoxetine and placebo at week 12.||-2.72|-7.39|<0.001
72497140|NCT00510276|144524084|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.61||||0.933|TWO_SIDED|95.0|-16.41|17.63|||ANCOVA|ANCOVA model with terms for baseline score, treatment, and investigator||Tested was the null hypothesis that there is no statistically significant difference in Driving Behavior Survey Other-Report score changes from baseline to 12-week endpoint between atomoxetine and placebo treatment groups.||17.63|-16.41|0.933
72497141|NCT00510276|144524085|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.95||||0.007|TWO_SIDED|95.0|-5.09|-0.81|||ANCOVA|ANCOVA model with terms for baseline score, treatment, and investigator||Tested was the null hypothesis that there is no statistically significant difference in BRIEF-A Behavioral regulation score changes from baseline to 12-week endpoint between atomoxetine and placebo treatment groups.||-0.81|-5.09|0.007
72497142|NCT00510276|144524086|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.58||||0.219|TWO_SIDED|95.0|-1.5|0.35|||ANCOVA|ANCOVA model with terms for baseline score, treatment, and investigator||Tested was the null hypothesis that there is no statistically significant difference in BRIEF-A emotional control section score changes from baseline to 12-week endpoint between atomoxetine and placebo treatment groups.||0.35|-1.50|0.219
72497143|NCT00510276|144524087|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.58||||0.002|TWO_SIDED|95.0|-12.37|-2.78|||ANCOVA|ANCOVA model with terms for baseline score, treatment, and investigator||Tested was the null hypothesis that there is no statistically significant difference in BRIEF-A GEC section score changes from baseline to 12-week endpoint between atomoxetine and placebo treatment groups.||-2.78|-12.37|0.002
72497144|NCT00510276|144524088|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.09||||0.644|TWO_SIDED|95.0|-0.47|0.29|||ANCOVA|ANCOVA model with terms for baseline score, treatment, and investigator||Tested was the null hypothesis that there is no statistically significant difference in BRIEF-A Inconsistency section score changes from baseline to 12-week endpoint between atomoxetine and placebo treatment groups.||0.29|-0.47|0.644
72497145|NCT00510276|144524089|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.11||||0.097|TWO_SIDED|95.0|-0.02|0.25|||ANCOVA|ANCOVA model with terms for baseline score, treatment, and investigator||Tested was the null hypothesis that there is no statistically significant difference in BRIEFS-A infrequency score changes from baseline to 12-week endpoint between atomoxetine and placebo treatment groups.||0.25|-0.02|0.097
72497146|NCT00510276|144524090|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.97||||0.002|TWO_SIDED|95.0|-1.57|-0.37|||ANCOVA|ANCOVA model with terms for baseline score, treatment, and investigator||Tested was the null hypothesis that there is no statistically significant difference in BRIEF-A Inhibit Section score changes from baseline to 12-week endpoint between atomoxetine and placebo treatment groups.||-0.37|-1.57|0.002
72497147|NCT00510276|144524091|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.67||||0.044|TWO_SIDED|95.0|-1.33|-0.02|||ANCOVA|ANCOVA model with terms for baseline score, treatment, and investigator||Tested was the null hypothesis that there is no statistically significant difference in BRIEF-A Initiate section score changes from baseline to 12-week endpoint between atomoxetine and placebo treatment groups.||-0.02|-1.33|0.044
72497148|NCT00510276|144524092|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.49||||0.003|TWO_SIDED|95.0|-7.43|-1.55|||ANCOVA|ANCOVA model with terms for baseline score, treatment, and investigator||Tested was the null hypothesis that there is no statistically significant difference in BRIEF-A Metacognition section score changes from baseline to 12-week endpoint between atomoxetine and placebo treatment groups.||-1.55|-7.43|0.003
72497149|NCT00510276|144524093|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.14||||0.456|TWO_SIDED|95.0|-0.51|0.23|||ANCOVA|ANCOVA model with terms for baseline score, treatment, and investigator||Tested was the null hypothesis that there is no statistically significant difference in BRIEF-A negativity section score changes from baseline to 12-week endpoint between atomoxetine and placebo treatment groups.||0.23|-0.51|0.456
72560182|NCT02654145|144651107|SUPERIORITY||Mean Difference (Final Values)|-0.9|||<|0.001|TWO_SIDED|95.0|-1.13|-0.66||p-value is for Difference (Mepo-Placebo) calculated based on the Historical Placebo estimate of -0.55 (Standard Error: 0.05), which was estimated from a meta-analysis of studies NCT01000506 and NCT01691521 using all Placebo participants.|Mixed Model Repeated Measures||Difference (Mepo-Placebo) calculated based on the Historical Placebo estimate of -0.55 (Standard Error: 0.05), which was estimated from a meta-analysis of studies NCT01000506 and NCT01691521 using all Placebo participants.|||-0.66|-1.13|<0.001
72560183|NCT02654145|144651107|SUPERIORITY||Mean Difference (Final Values)|-1.34|||<|0.001|TWO_SIDED|95.0|-1.68|-1.0||p- value for Difference (Mepo-Placebo) calculated based on the Historical Placebo estimate of -0.11 (Standard Error: 0.14), which was estimated from a meta-analysis of studies NCT01691521 and NCT02281318 using Placebo participants who previously used|Mixed Model Repeated Measures||Difference (Mepo-Placebo) calculated based on the Historical Placebo estimate of -0.11 (Standard Error: 0.14), which was estimated from a meta-analysis of studies NCT01691521 and NCT02281318 using Placebo participants who previously used Xolair.|||-1.00|-1.68|<0.001
72560184|NCT02654145|144651109|SUPERIORITY||Rate ratio|0.36|||<|0.001|TWO_SIDED|95.0|0.28|0.47|||Generalised Estimating Equations||Analysis performed using generalized estimating equation (GEE) model assuming a negative binomial distribution with a covariate of treatment period (pre-treatment , on- and off-treatment), logarithm of time as an offset variable|||0.47|0.28|<0.001
72560185|NCT02637141|144651111|SUPERIORITY|P-values smaller than 0.05 were considered statistically significant.|LS Mean Difference|-2.49|STANDARD_ERROR_OF_MEAN|7.1||0.7271|TWO_SIDED|95.0|-16.82|11.83|||ANCOVA|The model included baseline VH:CD ratio, site, and sex as covariates and treatment group as a fixed effect.||||11.83|-16.82|0.7271
72560186|NCT02637141|144651111|SUPERIORITY|P-values smaller than 0.05 were considered statistically significant.|LS Mean Difference|6.39|STANDARD_ERROR_OF_MEAN|6.67||0.3438|TWO_SIDED|95.0|-7.07|19.85|||ANCOVA|The model included baseline VH:CD ratio, site, and sex as covariates and treatment group as a fixed effect.||||19.85|-7.07|0.3438
72560187|NCT02637141|144651112|SUPERIORITY||LS Mean Difference|-14.32|STANDARD_ERROR_OF_MEAN|19.85||0.4746|TWO_SIDED|95.0|-54.39|25.74|||ANCOVA|The model included baseline VH:CD ratio, site, and sex as covariates and treatment group as a fixed effect.||||25.74|-54.39|0.4746
72560188|NCT02637141|144651112|SUPERIORITY||LS Mean Difference|-41.24|STANDARD_ERROR_OF_MEAN|18.85||0.0343|TWO_SIDED|95.0|-79.28|-3.2|||ANCOVA|The model included baseline VH:CD ratio, site, and sex as covariates and treatment group as a fixed effect.||||-3.2|-79.28|0.0343
72560189|NCT02637141|144651114|SUPERIORITY||LS Mean Difference|4402.25|STANDARD_ERROR_OF_MEAN|1717.4||0.014|TWO_SIDED|95.0|936.39|7868.1|||Mixed-effect Model Repeat Measurement|The model included baseline value, treatment group, site, sex, time point, and a time point-by-treatment group interaction term as fixed effects.||||7868.10|936.39|0.0140
72443886|NCT03897686|144401520|SUPERIORITY||LS-means difference|-26.695|STANDARD_ERROR_OF_MEAN|9.995||0.00847|TWO_SIDED|95.0|-46.46|-6.93||The threshold for statistical significance was p \<0.05.|ANCOVA|"Analysis of covariance (ANCOVA) adjusted for the baseline value with fixed factors of treatment group and radiological stage"||Contrasts for changes in pain WOMAC score at visit 4 (week 13)||-6.93|-46.46|0.00847
72443887|NCT03897686|144401520|SUPERIORITY||LS-means difference|-33.96|STANDARD_ERROR_OF_MEAN|10.29||0.00123|TWO_SIDED|95.0|-54.31|-13.62||The threshold for statistical significance was p \<0.05.|ANCOVA|"Analysis of covariance (ANCOVA) adjusted for the baseline value with fixed factors of treatment group and radiological stage"||Contrasts for changes in pain WOMAC score at visit 5 (week 25)||-13.62|-54.31|0.00123
72443888|NCT03897686|144401521|SUPERIORITY||LS-means difference|-0.146|STANDARD_ERROR_OF_MEAN|5.121||0.97733|TWO_SIDED|95.0|-10.271|9.98||The threshold for statistical significance was p \<0.05.|ANCOVA|"Analysis of covariance (ANCOVA) adjusted for the baseline value with fixed factors of treatment group and radiological stage"||Contrasts for changes in stiffness WOMAC score, visit 3||9.980|-10.271|0.97733
72443889|NCT03897686|144401521|SUPERIORITY||LS-means difference|-14.5|STANDARD_ERROR_OF_MEAN|5.29||0.00693|TWO_SIDED|95.0|-24.95|-4.04||The threshold for statistical significance was p \<0.05.|ANCOVA|"Analysis of covariance (ANCOVA) adjusted for the baseline value with fixed factors of treatment group and radiological stage"||Contrasts for changes in stiffness WOMAC score, visit 4||-4.04|-24.95|0.00693
72443890|NCT03897686|144401521|SUPERIORITY||LS-means difference|-16.18|STANDARD_ERROR_OF_MEAN|4.68||0.00073|TWO_SIDED|95.0|-25.44|-6.92||The threshold for statistical significance was p \<0.05.|ANCOVA|"Analysis of covariance (ANCOVA) adjusted for the baseline value with fixed factors of treatment group and radiological stage"||Contrasts for changes in pain WOMAC score at visit 5 (week 25)||-6.92|-25.44|0.00073
72443891|NCT03897686|144401521|SUPERIORITY||LS-means difference|-57.14|STANDARD_ERROR_OF_MEAN|32.1||0.07725|TWO_SIDED|95.0|-120.62|6.33||The threshold for statistical significance was p \<0.05.|ANCOVA|"Analysis of covariance (ANCOVA) adjusted for the baseline value with fixed factors of treatment group and radiological stage"||Contrasts for changes in functionality WOMAC score, visit 3||6.33|-120.62|0.07725
72443892|NCT03897686|144401521|SUPERIORITY||LS-means difference|-103.27|STANDARD_ERROR_OF_MEAN|33.92||0.00279|TWO_SIDED|95.0|-170.35|-36.2||The threshold for statistical significance was p \<0.05.|ANCOVA|"Analysis of covariance (ANCOVA) adjusted for the baseline value with fixed factors of treatment group and radiological stage"||Contrasts for changes in functionality WOMAC score, visit 4||-36.20|-170.35|0.00279
72443893|NCT03897686|144401521|SUPERIORITY||LS-means difference|-133.29|STANDARD_ERROR_OF_MEAN|35.26||0.00023|TWO_SIDED|95.0|-203.03|-63.55||The threshold for statistical significance was p \<0.05.|ANCOVA|"Analysis of covariance (ANCOVA) adjusted for the baseline value with fixed factors of treatment group and radiological stage"||Contrasts for changes in functionality WOMAC score, visit 5||-63.55|-203.03|0.00023
72443894|NCT03897686|144401522|SUPERIORITY||||||<|0.005||||||The level of significance was set to p \<0.05.|Chi-squared|P-value generated by Chi-squared test was ≤0.005 for each time point.||The Chi-Square test was used to determine whether there was a statistically significant difference in disposition of results between two groups.||||<0.005
72443895|NCT03897686|144401523|SUPERIORITY||||||<|0.005||||||The level of significance was set to p \<0.05.|Chi-squared|P-value generated by Chi-squared test was ≤0.005 for each time point.||The Chi-Square test was used to determine whether there was a statistically significant difference in disposition of results between two groups.||||<0.005
72443896|NCT03897686|144401525|SUPERIORITY|||||||0.05||||||The threshold for statistical significance was p \<0.05.|ANCOVA|||The mean number of paracetamol tablets was calculated taking into account only patients who had received paracetamol. ANCOVA was used to detect a difference in means of 2 groups at visit 3 (week 6).||||0.050
72443897|NCT03897686|144401525|SUPERIORITY|||||||0.004||||||The threshold for statistical significance was p \<0.05.|ANCOVA|||The mean number of paracetamol tablets was calculated taking into account only patients who had received paracetamol. ANCOVA was used to detect a difference in means of 2 groups at visit 4 (week 13).||||0.004
72443898|NCT04052516|144401528|OTHER|Cochran-Mantel-Haenszal test|Odds Ratio (OR)|1.7||||0.2991|TWO_SIDED|95.0|0.62|4.63|||Cochran-Mantel-Haenszel|||||4.63|0.62|0.2991
72443899|NCT04052516|144401528|OTHER|Cochran-Mantel-Haenszel Test|Odds Ratio (OR)|2.01||||0.1386|TWO_SIDED|95.0|0.8|5.08|||Cochran-Mantel-Haenszel|||||5.08|0.80|0.1386
72443900|NCT03416010|144401541|OTHER||||||<|0.001|||||||two-way ANOVA|||Null Hypothesis: There was no significant difference in Health Beliefs across those 4 time points.||||<0.001
72443901|NCT03416010|144401541|OTHER||||||<|0.001|||||||two-way ANOVA|||Null hypothesis: There was no significant difference between the full intervention group, COPE-P, and the attention-control group, Preg+, in Health Beliefs, as measured by the Healthy Lifestyle Beliefs measure, at T0 baseline, as well as at time points 1, immediately following the intervention, 2, 6 weeks after the infants' birth, and 3, 6 months after the infants' birth||||<0.001
72497150|NCT00510276|144524094|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.65||||0.051|TWO_SIDED|95.0|-1.31|0.0|||ANCOVA|ANCOVA model with terms for baseline score, treatment, and investigator||Tested was the null hypothesis that there is no statistically significant difference in BRIEF-A Organization of Materials section score changes from baseline to 12-week endpoint between atomoxetine and placebo treatment groups.||0.00|-1.31|0.051
72497151|NCT00510276|144524095|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.34||||0.002|TWO_SIDED|95.0|-2.19|-0.47|||ANCOVA|ANCOVA model with terms for baseline score, treatment, and investigator||Tested was the null hypothesis that there is no statistically significant difference in BRIEF-A Plan/Organize section score changes from baseline to 12-week endpoint between atomoxetine and placebo treatment groups.||-0.47|-2.19|0.002
72497152|NCT00510276|144524096|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.53||||0.045|TWO_SIDED|95.0|-1.04|-0.01|||ANCOVA|ANCOVA model with terms for baseline score, treatment, and investigator||Tested was the null hypothesis that there is no statistically significant difference in BRIEF-A SHIFT section score changes from baseline to 12-week endpoint between atomoxetine and placebo treatment groups.||-0.01|-1.04|0.045
72560190|NCT02637141|144651114|SUPERIORITY||LS Mean Difference|944.9|STANDARD_ERROR_OF_MEAN|1167.22||0.4228|TWO_SIDED|95.0|-1410.65|3300.44|||Mixed-effect Model Repeat Measurement|The model included baseline value, treatment group, site, sex, time point, and a time point-by-treatment group interaction term as fixed effects.||||3300.44|-1410.65|0.4228
72443902|NCT03416010|144401541|OTHER|||||||0.009|||||||two-way ANOVA|||Null hypothesis: There was no statistically significant interaction between the intervention group and time.||||0.009
72443903|NCT03416010|144401542|OTHER||||||<|0.001||||||Threshold for significance: p \<0.01|two-way ANOVA|||Null hypothesis: there was no significant difference in anxiety across the 4 time points.||||<0.001
72443904|NCT03416010|144401542|OTHER||||||<|0.001|||||||two-way ANOVA|||Null hypothesis: There was no significant difference between the two groups in anxiety at T0 baseline, as well as at timepoint 1(immediately following the intervention), timepoint 2 (6 weeks after the infants' birth), and timepoint 3 (6 months after the infants' birth).||||<0.001
72443905|NCT03416010|144401542|OTHER||||||<|0.001|||||||two-way ANOVA|||Null hypothesis: There was no statistically significant interaction between the intervention group and time.||||<0.001
72443906|NCT03416010|144401543|OTHER||||||<|0.001|||||||two-way ANOVA|||Null hypothesis: There was no significant difference in health behaviors across those 4 time points.||||<0.001
72443907|NCT03416010|144401543|OTHER||||||<|0.001|||||||two-way ANOVA|||||||<0.001
72443908|NCT03416010|144401543|OTHER||||||<|0.001|||||||two-way ANOVA|||Null Hypothesis: There was no statistically significant interaction between the intervention group and time.||||<0.001
72443909|NCT03416010|144401544|OTHER||||||<|0.001|||||||two-way ANOVA|||Null hypothesis: There was no significant difference in depressive symptoms across those 4 timepoints.||||<0.001
72497153|NCT00510276|144524097|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.83||||0.001|TWO_SIDED|95.0|-1.35|-0.32|||ANCOVA|ANCOVA model with terms for baseline score, treatment, and investigator||Tested was the null hypothesis that there is no statistically significant difference in BRIEF-A Self Monitor Section score changes from baseline to 12-week endpoint between atomoxetine and placebo treatment groups.||-0.32|-1.35|0.001
72443910|NCT03416010|144401544|OTHER||||||<|0.001|||||||two-way ANOVA|||Null hypothesis: There was no significant difference between the two groups in depressive symptoms at T0 baseline, as well as at time points 1, immediately following the intervention, 2, 6 weeks after the infants' birth, and 3, 6 months after the infants' birth.||||<0.001
72443911|NCT03416010|144401544|OTHER||||||<|0.001|||||||two-way ANOVA|||Null hypothesis: There was no statistically significant interaction between the intervention group and time.||||<0.001
72443912|NCT03416010|144401545|OTHER||||||<|0.001|||||||two-way ANOVA|||Null hypothesis: There was no significant difference in stress across those 4 time points.||||<0.001
72497154|NCT00510276|144524098|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.71||||0.008|TWO_SIDED|95.0|-1.23|-0.19|||ANCOVA|ANCOVA model with terms for baseline score, treatment, and investigator||Tested was the null hypothesis that there is no statistically significant difference in BRIEF-A Task Monitor section score changes from baseline to 12-week endpoint between atomoxetine and placebo treatment groups.||-0.19|-1.23|0.008
72497155|NCT00510276|144524099|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.3|||<|0.001|TWO_SIDED|95.0|-1.98|-0.63|||ANCOVA|ANCOVA model with terms for baseline score, treatment, and investigator||Tested was the null hypothesis that there is no statistically significant difference in BRIEF-A Working Memory section score changes from baseline to 12-week endpoint between atomoxetine and placebo treatment groups.||-0.63|-1.98|<0.001
72497156|NCT00510276|144524100|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.69||||0.065|TWO_SIDED|95.0|-1.42|0.04|||ANCOVA|ANCOVA model with terms for baseline score, treatment, and investigator||Tested was the null hypothesis that there is no statistically significant difference in ESS score changes from baseline to 12-week endpoint between atomoxetine and placebo treatment groups.||0.04|-1.42|0.065
72497157|NCT00510276|144524101|SUPERIORITY_OR_OTHER|||||||0.788||95.0|||||Cochran-Mantel-Haenszel|Tested was smoking status across treatment.||Tested was the null hypothesis that smoking status is not a predictor of response to atomoxetine treatment compared with placebo||||0.788
72497158|NCT00510276|144524102|SUPERIORITY_OR_OTHER|||||||0.482||95.0||||Tested was smoking status across treatment.|Cochran-Mantel-Haenszel|||Tested was the null hypothesis that smoking status is not a predictor of strong response to atomoxetine treatment compared with placebo||||0.482
72497159|NCT03486392|144524108|SUPERIORITY||Difference of least square (LS) Means|-6.75|STANDARD_ERROR_OF_MEAN|1.056|<|0.001|TWO_SIDED|95.0|-9.31|-4.19|||Dunnett's method|||||-4.19|-9.31|< 0.001
72497160|NCT03486392|144524108|SUPERIORITY||Difference of LS Means|-8.07|STANDARD_ERROR_OF_MEAN|0.921|<|0.001|TWO_SIDED|95.0|-10.31|-5.84|||Dunnett's method|||||-5.84|-10.31|< 0.001
72497161|NCT03486392|144524108|SUPERIORITY||Difference of LS Means|-10.04|STANDARD_ERROR_OF_MEAN|0.934|<|0.001|TWO_SIDED|95.0|-12.31|-7.78|||Dunnett's method|||||-7.78|-12.31|< 0.001
72497162|NCT03486392|144524108|SUPERIORITY||Difference of LS Means|-5.78|STANDARD_ERROR_OF_MEAN|0.91|<|0.001|TWO_SIDED|95.0|-7.99|-3.57|||Dunnett's method|||||-3.57|-7.99|< 0.001
72497163|NCT02649634|144524167|NON_INFERIORITY_OR_EQUIVALENCE|Estimated sample size needed was 90 (45/group). This was based on a sample size calculation for 2 groups with 0.05 alpha, 0.80 power, anticipating a medium effect size (most recent meta-analysis on efficacy of MI on dietary behaviours yielded a medium effect size of .53; Burke et al., 2003). Additionally, for MLM, estimates involving the Level 2 variable (i.e., participants) require samples larger than 50 (Maas \& Hox, 2005). Others have suggested 30-50 participants (Scherbaum \& Ferreter, 2009).|||||>|0.05||||||Significance threshold is p=.05.|Mixed Models Analysis|||Linear mixed modelling (LMM) was used||||>.05
72497164|NCT02649634|144524168|NON_INFERIORITY_OR_EQUIVALENCE|Estimated sample size needed was 90 (45/group). This was based on a sample size calculation for 2 groups with 0.05 alpha, 0.80 power, anticipating a medium effect size (most recent meta-analysis on efficacy of MI on dietary behaviours yielded a medium effect size of .53; Burke et al., 2003). Additionally, for MLM, estimates involving the Level 2 variable (i.e., participants) require samples larger than 50 (Maas \& Hox, 2005). Others have suggested 30-50 participants (Scherbaum \& Ferreter, 2009).|||||>|0.05||||||Significance threshold is p=.05|Mixed Models Analysis|||Linear Mixed Modelling (LMM) was used||||>.05
72560191|NCT02637141|144651115|SUPERIORITY||LS Mean Difference|17.8|STANDARD_ERROR_OF_MEAN|17.09||0.3034|TWO_SIDED|95.0|-16.68|52.29|||Mixed-effect Model Repeat Measurement|The model included baseline value, treatment group, site, sex, time point, and a time point-by-treatment group interaction term as fixed effects.||Analysis of Change From Baseline in Anti-DGP-IgA||52.29|-16.68|0.3034
72497165|NCT02649634|144524169|NON_INFERIORITY_OR_EQUIVALENCE|Estimated sample size needed was 90 (45/group). This was based on a sample size calculation for 2 groups with 0.05 alpha, 0.80 power, anticipating a medium effect size.||||||0.65|||||||t-test, 2 sided|||Treatment adherence was analyzed via an independent sample t-test comparing the groups on mean number of TrymGym sessions missed.||||.65
72497166|NCT02649634|144524170|NON_INFERIORITY_OR_EQUIVALENCE|Estimated sample size needed was 90 (45/group). This was based on a sample size calculation for 2 groups with 0.05 alpha, 0.80 power, anticipating a medium effect size (most recent meta-analysis on efficacy of MI on dietary behaviours yielded a medium effect size of .53; Burke et al., 2003). Additionally, for MLM, estimates involving the Level 2 variable (i.e., participants) require samples larger than 50 (Maas \& Hox, 2005). Others have suggested 30-50 participants (Scherbaum \& Ferreter, 2009).|||||>|0.05||||||Significance threshold is p=.05|Mixed Models Analysis|||Linear Mixed Modelling (LMM) was used||||>.05
72497167|NCT02649634|144524171|NON_INFERIORITY_OR_EQUIVALENCE|Estimated sample size needed was 90 (45/group). This was based on a sample size calculation for 2 groups with 0.05 alpha, 0.80 power, anticipating a medium effect size (most recent meta-analysis on efficacy of MI on dietary behaviours yielded a medium effect size of .53; Burke et al., 2003). Additionally, for MLM, estimates involving the Level 2 variable (i.e., participants) require samples larger than 50 (Maas \& Hox, 2005). Others have suggested 30-50 participants (Scherbaum \& Ferreter, 2009).|||||>|0.05||||||Significance threshold is p=.05|Mixed Models Analysis|||Linear Mixed Modelling (LMM) was used||||>.05
72497168|NCT02649634|144524172|NON_INFERIORITY_OR_EQUIVALENCE|Estimated sample size needed was 90 (45/group). This was based on a sample size calculation for 2 groups with 0.05 alpha, 0.80 power, anticipating a medium effect size (most recent meta-analysis on efficacy of MI on dietary behaviours yielded a medium effect size of .53; Burke et al., 2003). Additionally, for MLM, estimates involving the Level 2 variable (i.e., participants) require samples larger than 50 (Maas \& Hox, 2005). Others have suggested 30-50 participants (Scherbaum \& Ferreter, 2009).|||||>|0.05||||||Significance threshold is p=.05|Mixed Models Analysis|||Linear Mixed Modelling (LMM) was used.||||>.05
72497169|NCT02649634|144524173|NON_INFERIORITY_OR_EQUIVALENCE|Estimated sample size needed was 90 (45/group). This was based on a sample size calculation for 2 groups with 0.05 alpha, 0.80 power, anticipating a medium effect size (most recent meta-analysis on efficacy of MI on dietary behaviours yielded a medium effect size of .53; Burke et al., 2003). Additionally, for MLM, estimates involving the Level 2 variable (i.e., participants) require samples larger than 50 (Maas \& Hox, 2005). Others have suggested 30-50 participants (Scherbaum \& Ferreter, 2009).|||||>|0.05||||||Significance threshold is p=.05|Mixed Models Analysis|||Linear Mixed Modelling (LMM) was used.||||>.05
72497170|NCT02649634|144524174|NON_INFERIORITY_OR_EQUIVALENCE|Estimated sample size needed was 90 (45/group). This was based on a sample size calculation for 2 groups with 0.05 alpha, 0.80 power, anticipating a medium effect size (most recent meta-analysis on efficacy of MI on dietary behaviours yielded a medium effect size of .53; Burke et al., 2003). Additionally, for MLM, estimates involving the Level 2 variable (i.e., participants) require samples larger than 50 (Maas \& Hox, 2005). Others have suggested 30-50 participants (Scherbaum \& Ferreter, 2009).|||||>|0.05||||||Significance threshold is p=.05|Mixed Models Analysis|||Linear Mixed Modelling (LMM) was used.||||>.05
72497171|NCT02649634|144524175|NON_INFERIORITY_OR_EQUIVALENCE|Estimated sample size needed was 90 (45/group). This was based on a sample size calculation for 2 groups with 0.05 alpha, 0.80 power, anticipating a medium effect size (most recent meta-analysis on efficacy of MI on dietary behaviours yielded a medium effect size of .53; Burke et al., 2003). Additionally, for MLM, estimates involving the Level 2 variable (i.e., participants) require samples larger than 50 (Maas \& Hox, 2005). Others have suggested 30-50 participants (Scherbaum \& Ferreter, 2009).|||||>|0.05||||||Significance threshold is p=.05|Mixed Models Analysis|||Linear Mixed Modelling (LMM) was used.||||>.05
72560192|NCT02637141|144651115|SUPERIORITY||LS Mean Difference|-6.92|STANDARD_ERROR_OF_MEAN|15.46||0.6569|TWO_SIDED|95.0|-38.11|24.28|||Mixed-effect Model Repeat Measurement|The model included baseline value, treatment group, site, sex, time point, and a time point-by-treatment group interaction term as fixed effects.||Analysis of Change From Baseline in Anti-DGP-IgA||24.28|-38.11|0.6569
72560193|NCT02637141|144651115|SUPERIORITY||LS Mean Difference|13.17|STANDARD_ERROR_OF_MEAN|26.77||0.6254|TWO_SIDED|95.0|-40.86|67.2|||Mixed-effect Model Repeat Measurement|The model included baseline value, treatment group, site, sex, time point, and a time point-by-treatment group interaction term as fixed effects.||Analysis of Change From Baseline in Anti-DGP-IgG||67.20|-40.86|0.6254
72560194|NCT02637141|144651115|SUPERIORITY||LS Mean Difference|2.86|STANDARD_ERROR_OF_MEAN|21.66||0.8955|TWO_SIDED|95.0|-40.84|46.57|||Mixed-effect Model Repeat Measurement|The model included baseline value, treatment group, site, sex, time point, and a time point-by-treatment group interaction term as fixed effects.||Analysis of Change From Baseline in Anti-DGP IgG||46.57|-40.84|0.8955
72497172|NCT02649634|144524176|NON_INFERIORITY_OR_EQUIVALENCE|Estimated sample size needed was 90 (45/group). This was based on a sample size calculation for 2 groups with 0.05 alpha, 0.80 power, anticipating a medium effect size (most recent meta-analysis on efficacy of MI on dietary behaviours yielded a medium effect size of .53; Burke et al., 2003). Additionally, for MLM, estimates involving the Level 2 variable (i.e., participants) require samples larger than 50 (Maas \& Hox, 2005). Others have suggested 30-50 participants (Scherbaum \& Ferreter, 2009).|||||>|0.05||||||Significance threshold is p=.05|Mixed Models Analysis|||Linear Mixed Modelling (LMM) was used.||||>.05
72497173|NCT02649634|144524177|NON_INFERIORITY_OR_EQUIVALENCE|Estimated sample size needed was 90 (45/group). This was based on a sample size calculation for 2 groups with 0.05 alpha, 0.80 power, anticipating a medium effect size (most recent meta-analysis on efficacy of MI on dietary behaviours yielded a medium effect size of .53; Burke et al., 2003). Additionally, for MLM, estimates involving the Level 2 variable (i.e., participants) require samples larger than 50 (Maas \& Hox, 2005). Others have suggested 30-50 participants (Scherbaum \& Ferreter, 2009).|||||>|0.05||||||Significance threshold is p=.05|Mixed Models Analysis|||Linear Mixed Modelling (LMM) was used.||||>.05
72497174|NCT02649634|144524178|NON_INFERIORITY_OR_EQUIVALENCE|Estimated sample size needed was 90 (45/group). This was based on a sample size calculation for 2 groups with 0.05 alpha, 0.80 power, anticipating a medium effect size (most recent meta-analysis on efficacy of MI on dietary behaviours yielded a medium effect size of .53; Burke et al., 2003). Additionally, for MLM, estimates involving the Level 2 variable (i.e., participants) require samples larger than 50 (Maas \& Hox, 2005). Others have suggested 30-50 participants (Scherbaum \& Ferreter, 2009).|||||>|0.05||||||Significance threshold is p=.05|Mixed Models Analysis|||Linear Mixed Modelling (LMM) was used.||||>.05
72497175|NCT02649634|144524179|NON_INFERIORITY_OR_EQUIVALENCE|Estimated sample size needed was 90 (45/group). This was based on a sample size calculation for 2 groups with 0.05 alpha, 0.80 power, anticipating a medium effect size (most recent meta-analysis on efficacy of MI on dietary behaviours yielded a medium effect size of .53; Burke et al., 2003). Additionally, for MLM, estimates involving the Level 2 variable (i.e., participants) require samples larger than 50 (Maas \& Hox, 2005). Others have suggested 30-50 participants (Scherbaum \& Ferreter, 2009).|||||>|0.05||||||Significance threshold is p=.05|Mixed Models Analysis|||Linear Mixed Modelling (LMM) was used.||||>.05
72497176|NCT02649634|144524180|NON_INFERIORITY_OR_EQUIVALENCE|Estimated sample size needed was 90 (45/group). This was based on a sample size calculation for 2 groups with 0.05 alpha, 0.80 power, anticipating a medium effect size (most recent meta-analysis on efficacy of MI on dietary behaviours yielded a medium effect size of .53; Burke et al., 2003). Additionally, for MLM, estimates involving the Level 2 variable (i.e., participants) require samples larger than 50 (Maas \& Hox, 2005). Others have suggested 30-50 participants (Scherbaum \& Ferreter, 2009).|||||>|0.05||||||Significance threshold is p=.05|Mixed Models Analysis|||Linear Mixed Modelling (LMM) was used.||||>.05
72497177|NCT02649634|144524181|NON_INFERIORITY_OR_EQUIVALENCE|Estimated sample size needed was 90 (45/group). This was based on a sample size calculation for 2 groups with 0.05 alpha, 0.80 power, anticipating a medium effect size (most recent meta-analysis on efficacy of MI on dietary behaviours yielded a medium effect size of .53; Burke et al., 2003). Additionally, for MLM, estimates involving the Level 2 variable (i.e., participants) require samples larger than 50 (Maas \& Hox, 2005). Others have suggested 30-50 participants (Scherbaum \& Ferreter, 2009).|||||>|0.05||||||Significance threshold is p=.05|Mixed Models Analysis|||Linear Mixed Modelling (LMM) was used.||||>.05
72560195|NCT02637141|144651116|SUPERIORITY||Ratio of LS Means|0.83|STANDARD_ERROR_OF_MEAN|0.11||0.161|TWO_SIDED|95.0|0.63|1.08|||Generalized Linear Mixed Model|Generalized linear mixed model with treatment group, site, sex, time (week), and time point-by-treatment group interaction as fixed effects.||Analysis of Total Weekly Bowel Movements at Week 12||1.08|0.63|0.1610
72560196|NCT02637141|144651116|SUPERIORITY||Ratio of LS Means|1.03|STANDARD_ERROR_OF_MEAN|0.13||0.781|TWO_SIDED|95.0|0.81|1.32|||Generalized Linear Mixed Model|Generalized linear mixed model with treatment group, site, sex, time (week), and time point-by-treatment group interaction as fixed effects.||||1.32|0.81|0.7810
72560197|NCT02637141|144651118|SUPERIORITY||LS Mean Difference|-13.44|STANDARD_ERROR_OF_MEAN|12.33||0.2761|TWO_SIDED|95.0|-37.66|10.77|||Mixed-effect Model Repeat Measurement|The model included baseline value, treatment group, site, sex, time point, and a time point-by-treatment group interaction term as fixed effects.||||10.77|-37.66|0.2761
72560198|NCT02637141|144651118|SUPERIORITY||LS Mean Difference|-2.62|STANDARD_ERROR_OF_MEAN|11.66||0.8221|TWO_SIDED|95.0|-25.51|20.27|||Mixed-effect Model Repeat Measurement|The model included baseline value, treatment group, site, sex, time point, and a time point-by-treatment group interaction term as fixed effects.||||20.27|-25.51|0.8221
72389008|NCT01817530|144286171|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Final Visit||||< 0.001
72389009|NCT01817530|144286171|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Final Visit||||< 0.001
72389010|NCT01817530|144286171|SUPERIORITY|||||||0.002||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Final Visit||||0.002
72443913|NCT03416010|144401545|OTHER||||||<|0.001|||||||two-way ANOVA|||Null hypothesis: There was no significant difference between the two groups in stress, as measured by the GAD-7, at T0 baseline, as well as at timepoint 1 (immediately following the intervention), timepoint 2 (6 weeks after the infants' birth) and timepoint 3 (6 months after the infants' birth).||||<0.001
72497178|NCT02649634|144524182|NON_INFERIORITY_OR_EQUIVALENCE|Estimated sample size needed was 90 (45/group). This was based on a sample size calculation for 2 groups with 0.05 alpha, 0.80 power, anticipating a medium effect size (most recent meta-analysis on efficacy of MI on dietary behaviours yielded a medium effect size of .53; Burke et al., 2003). Additionally, for MLM, estimates involving the Level 2 variable (i.e., participants) require samples larger than 50 (Maas \& Hox, 2005). Others have suggested 30-50 participants (Scherbaum \& Ferreter, 2009).|||||>|0.05||||||Significance threshold is p=.05|Mixed Models Analysis|||Linear Mixed Modelling (LMM) was used.||||>.05
72497179|NCT02649634|144524183|NON_INFERIORITY_OR_EQUIVALENCE|Estimated sample size needed was 90 (45/group). This was based on a sample size calculation for 2 groups with 0.05 alpha, 0.80 power, anticipating a medium effect size.|||||>|0.05||||||Significance threshold is p=.05|t-test, 2 sided|||Self-efficacy was analyzed via an independent sample t-test comparing the groups on mean global self efficacy rating on the WEL.||||>.05
72497180|NCT02649634|144524184|NON_INFERIORITY_OR_EQUIVALENCE|Estimated sample size needed was 90 (45/group). This was based on a sample size calculation for 2 groups with 0.05 alpha, 0.80 power, anticipating a medium effect size.|||||>|0.05||||||Significance threshold is p=.05|t-test, 2 sided|||Self-efficacy was analyzed via an independent sample t-test comparing the groups on mean self efficacy rating on the ESE.||||>.05
72560199|NCT02637141|144651119|SUPERIORITY||LS Mean Difference|-2.76|STANDARD_ERROR_OF_MEAN|2.1||0.1908|TWO_SIDED|95.0|-6.89|1.3|||Mixed-effect Model Repeat Measurement|The model included baseline value, treatment group, site, sex, time point, and a time point-by-treatment group interaction term as fixed effects.||||1.3|-6.89|0.1908
72560200|NCT02637141|144651119|SUPERIORITY||LS Mean Difference|-1.64|STANDARD_ERROR_OF_MEAN|1.98||0.4088|TWO_SIDED|95.0|-5.53|2.25|||Mixed-effect Model Repeat Measurement|The model included baseline value, treatment group, site, sex, time point, and a time point-by-treatment group interaction term as fixed effects.||||2.25|-5.53|0.4088
72560201|NCT01943435|144651121|SUPERIORITY|For this superiority study, sample size estimation was based upon hypothesized changes in our primary outcome measure, the Swiss Spinal Stenosis (SSS) questionnaire. We calculated that a total sample size of 180 subjects (n=60 per group) would give us 80% power to detect a difference as small as 3.6 points on the Swiss Spinal Stenosis questionnaire score. Sample size was increased at the request of the funding agency without any interim analysis performed.|Mean Difference (Final Values)|0.3||||0.73|TWO_SIDED|95.0|-1.5|2.2|||Regression, Linear|Linear mixed models were adjusted for randomization stratification factors.||The primary analysis was a between-groups comparison of means using linear mixed models with SSS total score as the dependent variable, while adjusting for randomization stratification factors.||2.2|-1.5|0.73
72560202|NCT01943435|144651121|SUPERIORITY|For this superiority study, sample size estimation was based upon hypothesized changes in our primary outcome measure, the Swiss Spinal Stenosis (SSS) questionnaire. We calculated that a total sample size of 180 subjects (n=60 per group) would give us 80% power to detect a difference as small as 3.6 points on the Swiss Spinal Stenosis questionnaire score. Sample size was increased at the request of the funding agency without any interim analysis performed.|Mean Difference (Final Values)|-2.1||||0.02|TWO_SIDED|95.0|-3.9|-0.3|||Regression, Linear|Linear mixed models were adjusted for randomization stratification factors.||The primary analysis was a between-groups comparison of means using linear mixed models with SSS total score as the dependent variable, while adjusting for randomization stratification factors.||-0.3|-3.9|0.02
72560203|NCT01943435|144651121|SUPERIORITY|For this superiority study, sample size estimation was based upon hypothesized changes in our primary outcome measure, the Swiss Spinal Stenosis (SSS) questionnaire. We calculated that a total sample size of 180 subjects (n=60 per group) would give us 80% power to detect a difference as small as 3.6 points on the Swiss Spinal Stenosis questionnaire score. Sample size was increased at the request of the funding agency without any interim analysis performed.|Mean Difference (Final Values)|2.4||||0.01|TWO_SIDED|95.0|0.6|4.3|||Regression, Linear|Linear mixed models were adjusted for randomization stratification factors.||The primary analysis was a between-groups comparison of means using linear mixed models with SSS total score as the dependent variable, while adjusting for randomization stratification factors.||4.3|0.6|0.01
72560204|NCT01943435|144651122|SUPERIORITY||Mean Difference (Final Values)|87.0||||0.29|TWO_SIDED|95.0|-75.2|249.2|||Regression, Linear|Linear mixed models were adjusted for randomization stratification factors.||This analysis consisted of a between-groups comparison of means using linear mixed models with SPWT as the dependent variable, while adjusting for randomization stratification factors.||249.2|-75.2|0.29
72560205|NCT01943435|144651122|SUPERIORITY||Mean Difference (Final Values)|129.7||||0.1|TWO_SIDED|95.0|-27.2|286.6|||Regression, Linear|Linear mixed models were adjusted for randomization stratification factors.||This analysis consisted of a between-groups comparison of means using linear mixed models with SPWT as the dependent variable, while adjusting for randomization stratification factors.||286.6|-27.2|0.10
72443914|NCT03416010|144401545|OTHER||||||<|0.001|||||||two-way ANOVA|||Null hypothesis: There was no statistically significant interaction between the intervention group and time.||||<0.001
72443915|NCT04505774|144401617|SUPERIORITY|||||||0.6778|||||||t-test, 2 sided|||||||.6778
72443916|NCT04505774|144401617|SUPERIORITY|||||||0.6292|||||||t-test, 2 sided|||||||.6292
72443917|NCT04505774|144401617|SUPERIORITY|||||||0.6858|||||||t-test, 2 sided|||||||.6858
72443918|NCT04505774|144401617|SUPERIORITY|||||||0.1351|||||||t-test, 2 sided|||||||.1351
72443919|NCT04505774|144401618|SUPERIORITY|||||||0.1959|||||||Chi-squared|||||||.1959
72443920|NCT04505774|144401618|SUPERIORITY|||||||0.9496|||||||Chi-squared|||||||0.9496
72443921|NCT04505774|144401618|SUPERIORITY|||||||0.9902|||||||Chi-squared|||||||.9902
72443922|NCT04505774|144401618|SUPERIORITY|||||||0.0814|||||||Chi-squared|||||||.0814
72443923|NCT04505774|144401619|SUPERIORITY|||||||1|||||||Chi-squared|||||||1.0
72443924|NCT04505774|144401619|SUPERIORITY|||||||1|||||||Chi-squared|||||||1
72443925|NCT04505774|144401619|SUPERIORITY|||||||1|||||||Chi-squared|||||||1
72443926|NCT04505774|144401620|SUPERIORITY|||||||0.0577|||||||Chi-squared|||||||.0577
72443927|NCT04505774|144401620|SUPERIORITY|||||||0.5015|||||||Chi-squared|||||||.5015
72443928|NCT04505774|144401620|SUPERIORITY|||||||0.5892|||||||Chi-squared|||||||.5892
72443929|NCT04505774|144401620|SUPERIORITY|||||||0.1714|||||||Chi-squared|||||||.1714
72443930|NCT04505774|144401621|SUPERIORITY|||||||0.0732|||||||Chi-squared|||||||.0732
72443931|NCT04505774|144401621|SUPERIORITY|||||||0.9018|||||||Chi-squared|||||||.9018
72443932|NCT04505774|144401621|SUPERIORITY|||||||0.5075|||||||Chi-squared|||||||.5075
72443933|NCT04505774|144401621|SUPERIORITY|||||||0.145|||||||Chi-squared|||||||.1450
72443934|NCT04505774|144401622|SUPERIORITY|||||||0.8837|||||||Chi-squared|||||||.8837
72443935|NCT04505774|144401622|SUPERIORITY|||||||1|||||||Chi-squared|||||||1
72443936|NCT04505774|144401622|SUPERIORITY|||||||1|||||||Chi-squared|||||||1
72443937|NCT04505774|144401622|SUPERIORITY|||||||0.5343|||||||Chi-squared|||||||.5343
72443938|NCT04505774|144401623|SUPERIORITY|||||||0.6636|||||||t-test, 2 sided|||||||.6636
72443939|NCT04505774|144401623|SUPERIORITY|||||||0.5878|||||||t-test, 2 sided|||||||.5878
72443940|NCT04505774|144401623|SUPERIORITY|||||||0.7148|||||||t-test, 2 sided|||||||.7148
72443941|NCT04505774|144401623|SUPERIORITY|||||||0.1117|||||||t-test, 2 sided|||||||.1117
72443942|NCT04505774|144401624|SUPERIORITY|||||||0.678|||||||t-test, 2 sided|||||||.6780
72443943|NCT04505774|144401624|SUPERIORITY|||||||0.6638|||||||t-test, 2 sided|||||||.6638
72443944|NCT04505774|144401624|SUPERIORITY|||||||0.7645|||||||t-test, 2 sided|||||||.7645
72443945|NCT04505774|144401624|SUPERIORITY|||||||0.0987|||||||t-test, 2 sided|||||||0.0987
72443946|NCT04505774|144401625|SUPERIORITY|||||||0.4016|||||||t-test, 2 sided|||||||.4016
72443947|NCT04505774|144401625|SUPERIORITY|||||||0.5815|||||||t-test, 2 sided|||||||.5815
72443948|NCT04505774|144401625|SUPERIORITY|||||||0.9085|||||||t-test, 2 sided|||||||.9085
72443949|NCT04505774|144401625|SUPERIORITY|||||||0.082|||||||t-test, 2 sided|||||||.0820
72443950|NCT04505774|144401626|SUPERIORITY|||||||0.3135|||||||Chi-squared|||||||.3135
72443951|NCT04505774|144401626|SUPERIORITY|||||||0.9581|||||||Chi-squared|||||||.9581
72443952|NCT04505774|144401626|SUPERIORITY|||||||0.9661|||||||Chi-squared|||||||.9661
72443953|NCT04505774|144401626|SUPERIORITY|||||||0.1073|||||||Chi-squared|||||||.1073
72443954|NCT04505774|144401627|SUPERIORITY|||||||0.3575|||||||Chi-squared|||||||.3575
72443955|NCT04505774|144401627|SUPERIORITY|||||||0.591|||||||Chi-squared|||||||.5910
72443956|NCT04505774|144401627|SUPERIORITY|||||||0.867|||||||Chi-squared|||||||.8670
72443957|NCT04505774|144401627|SUPERIORITY|||||||0.0645|||||||Chi-squared|||||||.0645
72443958|NCT06023082|144401629|OTHER||||||<|0.0001||||||Baseline to Week 12 comparison.|ANOVA|||||||<0.0001
72443959|NCT06023082|144401630|OTHER||||||<|0.0001|||||||ANOVA|||||||<0.0001
72443960|NCT06023082|144401631|OTHER||||||<|0.0001||||||Baseline to Week 12 comparison.|ANOVA|||||||<0.0001
72443961|NCT06023082|144401632|OTHER||||||<|0.0001||||||Baseline to Week 12 comparison.|ANOVA|||||||<0.0001
72443962|NCT06023082|144401633|OTHER|||||||0.4907||||||Baseline to Week 12 comparison.|ANOVA|||||||0.4907
72443963|NCT06023082|144401634|OTHER||||||<|0.0001||||||Baseline to Week 12 comparison.|ANOVA|||||||<0.0001
72443964|NCT06023082|144401635|OTHER||||||<|0.0001||||||Baseline to Week 12 comparison.|ANOVA|||||||<0.0001
72443965|NCT06023082|144401636|OTHER||||||<|0.0001||||||Baseline to Week 12 comparison.|ANOVA|||||||<0.0001
72443966|NCT06023082|144401637|OTHER|||||||0.0016||||||Baseline to Week 12 comparison.|ANOVA|||||||0.0016
72443967|NCT06023082|144401638|OTHER||||||<|0.0001||||||Baseline to Week 12 comparison.|ANOVA|||||||<0.0001
72443968|NCT06023082|144401639|OTHER||||||<|0.0001||||||Baseline to Week 12 comparison.|ANOVA|||||||<0.0001
72443969|NCT06023082|144401640|OTHER||||||<|0.0001||||||Baseline to Week 12 comparison.|ANOVA|||||||<0.0001
72443970|NCT06023082|144401641|OTHER|||||||0.0002||||||Baseline to Week 12 comparison.|ANOVA|||||||0.0002
72443971|NCT06023082|144401642|OTHER|||||||0.001||||||Baseline to Week 12 comparison.|ANOVA|||||||0.001
72443972|NCT06023082|144401643|OTHER||||||<|0.0001||||||Baseline to Week 12 comparison.|ANOVA|||||||<0.0001
72443973|NCT06023082|144401644|OTHER||||||<|0.0001||||||Baseline to Week 12 comparison.|ANOVA|||||||<0.0001
72443974|NCT06023082|144401645|OTHER||||||<|0.0001||||||Baseline to Week 12 comparison.|ANOVA|||||||<0.0001
72443975|NCT06023082|144401646|OTHER||||||<|0.0001|||||||ANOVA|||Baseline to Week 12 comparison.||||<0.0001
72443976|NCT06023082|144401647|OTHER||||||<|0.0001||||||Baseline to Week 10 comparison.|ANOVA|||||||<0.0001
72443977|NCT06023082|144401648|OTHER||||||<|0.0001||||||Baseline to Week 12 comparison.|ANOVA|||||||<0.0001
72443978|NCT06023082|144401649|OTHER||||||<|0.0001||||||Baseline to Week 12 comparison.|ANOVA|||||||<0.0001
72443979|NCT06023082|144401650|OTHER||||||<|0.0001||||||Baseline to Week 12 comparison.|ANOVA|||||||<0.0001
72443980|NCT06023082|144401651|OTHER||||||<|0.0001||||||Baseline to Week 12 comparison.|ANOVA|||||||<0.0001
72443981|NCT05343390|144401708|SUPERIORITY||Mean Difference (Final Values)|20.6|||<|0.001|TWO_SIDED|95.0|16.1|25.1|||Regression, Linear|A linear model fit using generalized estimating equations to account for correlated observations within clusters.||||25.1|16.1|<0.001
72443982|NCT05343390|144401709|SUPERIORITY||Mean Difference (Final Values)|11.1|||<|0.001|TWO_SIDED|95.0|5.9|16.4|||Regression, Linear|A linear model fit using generalized estimating equations to account for correlated observations within clusters.||||16.4|5.9|<0.001
72443983|NCT05343390|144401710|SUPERIORITY||Rate Ratio|1.22||||0.14|TWO_SIDED|95.0|0.93|1.6|||Mixed Models Analysis|Negative binomial mixed-effect model||||1.60|0.93|0.14
72443984|NCT05343390|144401711|SUPERIORITY||Rate Ratio|1.37||||0.006|TWO_SIDED|95.0|1.1|1.71|||Mixed Models Analysis|Negative binomial mixed-effect model||||1.71|1.10|0.006
72443985|NCT05343390|144401712|SUPERIORITY||Rate Ratio|2.29||||0.013|TWO_SIDED|95.0|1.19|4.4|||Mixed Models Analysis|Negative binomial mixed-effect model||||4.40|1.19|0.013
72443986|NCT05343390|144401713|SUPERIORITY||Rate Ratio|1.45||||0.01|TWO_SIDED|95.0|1.1|1.92|||Mixed Models Analysis|Negative binomial mixed-effect model||||1.92|1.10|0.01
72443987|NCT05343390|144401714|SUPERIORITY||Rate Ratio|1.28||||0.12|TWO_SIDED|95.0|0.94|1.76|||Mixed Models Analysis|Negative binomial mixed-effect model||||1.76|0.94|0.12
72443988|NCT05141903|144401745|SUPERIORITY||||||<|0.0001||||||(Dose group \* Time)|Mixed Models Analysis|Dfn, Dfd = 11, 369 F Value = 24.31||Dose Group 2 B. infantis levels compared to control group (antibiotic only) with changes over time||||<0.0001
72443989|NCT05141903|144401745|SUPERIORITY||||||<|0.0001||||||Dose group \* Time|Mixed Models Analysis|Dfn, Dfd = 11, 370 F value = 14.87||Dose Group 3 B. infantis levels compared to control group (antibiotic only) with changes over time||||<0.0001
72443990|NCT05141903|144401745|SUPERIORITY||||||<|0.0001||||||Dose Group \* Time|Mixed Models Analysis|Dfn, Dfd = 11, 351 F value = 8.606||Dose Group 2 (with HMO) B. infantis levels compared to dose Group 3 (without HMO) with changes over time||||<0.0001
72443991|NCT02140645|144401796|SUPERIORITY_OR_OTHER||C-statistics|0.624|||||||||||||The C-statistics can be between 0.5 and 1 and a value of 0.5 indicates that the model is no better than chance at making a prediction and a value of 1.0 indicates that the model perfectly identifies those within a group and those not.|||||
72443992|NCT02140645|144401797|SUPERIORITY_OR_OTHER||C-statistcs|0.597|||||||||||||The C-statistics can be between 0.5 and 1 and a value of 0.5 indicates that the model is no better than chance at making a prediction and a value of 1.0 indicates that the model perfectly identifies those within a group and those not.|||||
72443993|NCT02140645|144401798|SUPERIORITY_OR_OTHER||R-squared|0.0858|||||||||||||The R-squared can be between 0 and 1 and a value of 0 indicates that the model is no better than chance at making a prediction and a value of 1.0 indicates that the model perfectly identifies those within a group and those not.|||||
72443994|NCT02140645|144401799|SUPERIORITY_OR_OTHER||C-statistics|0.623|||||||||||||The C-statistics can be between 0.5 and 1 and a value of 0.5 indicates that the model is no better than chance at making a prediction and a value of 1.0 indicates that the model perfectly identifies those within a group and those not.|||||
72443995|NCT02140645|144401800|SUPERIORITY_OR_OTHER||R-squared|0.1753|||||||||||||The R-squared can be between 0 and 1 and a value of 0 indicates that the model is no better than chance at making a prediction and a value of 1.0 indicates that the model perfectly identifies those within a group and those not.|||||
72443996|NCT02140645|144401801|SUPERIORITY_OR_OTHER||C-statistics|0.699|||||||||||||The C-statistics can be between 0.5 and 1 and a value of 0.5 indicates that the model is no better than chance at making a prediction and a value of 1.0 indicates that the model perfectly identifies those within a group and those not.|||||
72443997|NCT02140645|144401802|SUPERIORITY_OR_OTHER||C-statistics|0.683|||||||||||||The C-statistics can be between 0.5 and 1 and a value of 0.5 indicates that the model is no better than chance at making a prediction and a value of 1.0 indicates that the model perfectly identifies those within a group and those not.|||||
72443998|NCT02140645|144401803|SUPERIORITY_OR_OTHER||C-statistics|0.757|||||||||||||The C-statistics can be between 0.5 and 1 and a value of 0.5 indicates that the model is no better than chance at making a prediction and a value of 1.0 indicates that the model perfectly identifies those within a group and those not.|||||
72443999|NCT02140645|144401804|SUPERIORITY_OR_OTHER||C-statistics|0.618|||||||||||||The C-statistics can be between 0.5 and 1 and a value of 0.5 indicates that the model is no better than chance at making a prediction and a value of 1.0 indicates that the model perfectly identifies those within a group and those not.|||||
72444000|NCT02140645|144401805|SUPERIORITY_OR_OTHER||C-statistics|0.618|||||||||||||The C-statistics can be between 0.5 and 1 and a value of 0.5 indicates that the model is no better than chance at making a prediction and a value of 1.0 indicates that the model perfectly identifies those within a group and those not.|||||
72444001|NCT02140645|144401806|SUPERIORITY_OR_OTHER||C-statistics|0.733|||||||||||||The C-statistics can be between 0.5 and 1 and a value of 0.5 indicates that the model is no better than chance at making a prediction and a value of 1.0 indicates that the model perfectly identifies those within a group and those not.|||||
72444002|NCT02140645|144401807|SUPERIORITY_OR_OTHER||C-statistics|0.827|||||||||||||The C-statistics can be between 0.5 and 1 and a value of 0.5 indicates that the model is no better than chance at making a prediction and a value of 1.0 indicates that the model perfectly identifies those within a group and those not.|||||
72444003|NCT02140645|144401808|SUPERIORITY_OR_OTHER||C-statistics|0.801|||||||||||||The C-statistics can be between 0.5 and 1 and a value of 0.5 indicates that the model is no better than chance at making a prediction and a value of 1.0 indicates that the model perfectly identifies those within a group and those not.|||||
72444004|NCT02140645|144401809|SUPERIORITY_OR_OTHER||C-statistics|0.836|||||||||||||The C-statistics can be between 0.5 and 1 and a value of 0.5 indicates that the model is no better than chance at making a prediction and a value of 1.0 indicates that the model perfectly identifies those within a group and those not.|||||
72444005|NCT03580369|144401823|SUPERIORITY||LS Mean|-8.002|STANDARD_ERROR_OF_MEAN|1.313|<|0.0001|TWO_SIDED|95.0|-10.576|-5.428|||Mixed Models Analysis|Linear mixed model with repeated measures (MMRM)||Treatment contrast in LS mean (change), Adults||-5.428|-10.576|<.0001
72444006|NCT03580369|144401823|SUPERIORITY||LS mean|0.672|STANDARD_ERROR_OF_MEAN|0.939||0.7628|TWO_SIDED|95.0|-1.169|2.513|||Mixed Models Analysis|Linear mixed model with repeated measures (MMRM)||Treatment contrast in LS mean (change), Adults||2.513|-1.169|0.7628
72444007|NCT03580369|144401823|SUPERIORITY||LS Mean|-7.964|STANDARD_ERROR_OF_MEAN|1.305|<|0.0001|TWO_SIDED|95.0|-10.522|-5.047|||Mixed Models Analysis|Linear mixed model with repeated measures (MMRM)||Treatment contrast in LS mean (change), Adults||-5.047|-10.522|<.0001
72444008|NCT03580369|144401823|SUPERIORITY||LS mean|0.71|STANDARD_ERROR_OF_MEAN|0.933||0.7768|TWO_SIDED|95.0|-1.118|2.538|||Mixed Models Analysis|Linear mixed model with repeated measures (MMRM)||Treatment contrast in LS mean (change), Adults||2.538|-1.118|0.7768
72444009|NCT03580369|144401825|SUPERIORITY|Wald chi-square test based on logistic regression|Odds Ratio (OR)|5.68|||<|0.0001|TWO_SIDED|95.0|2.667|12.095|||Regression, Logistic|95% confidence interval for the odds ratio||Adults||12.095|2.667|<.0001
72560206|NCT01943435|144651122|SUPERIORITY||Mean Difference (Final Values)|-42.7||||0.61|TWO_SIDED|95.0|-205.4|120.0|||Regression, Linear|Linear mixed models were adjusted for randomization stratification factors.||This analysis consisted of a between-groups comparison of means using linear mixed models with SPWT as the dependent variable, while adjusting for randomization stratification factors.||120.0|-205.4|0.61
72560207|NCT01943435|144651123|SUPERIORITY||Mean Difference (Final Values)|30.5||||0.03|TWO_SIDED|95.0|3.1|57.9|||Regression, Linear|Linear mixed models were adjusted for randomization stratification factors.||This secondary analysis consisted of a between-groups comparison of means using linear regression with physical activity as the dependent variable (average number of minutes spent daily in activities \>1.5 METs), while adjusting for randomization stratification factors.||57.9|3.1|0.03
72444010|NCT03580369|144401825|SUPERIORITY|Wald chi-square test based on logistic regression|Odds Ratio (OR)|0.84||||0.843|TWO_SIDED|95.0|0.598|1.18|||Regression, Logistic|95% confidence interval for the odds ratio||Adults||1.180|0.598|0.8430
72444011|NCT03580369|144401825|SUPERIORITY|Wald chi-square test based on logistic regression|Odds Ratio (OR)|5.734|||<|0.0001|TWO_SIDED|95.0|2.694|12.207|||Regression, Logistic|95% confidence interval for the odds ratio||Adults||12.207|2.694|<.0001
72444012|NCT03580369|144401825|SUPERIORITY|Wald chi-square test based on logistic regression|Odds Ratio, log|0.848||||0.8312|TWO_SIDED|95.0|0.605|1.188|||Regression, Logistic|95% confidence interval for the odds ratio||Adults||1.188|0.605|0.8312
72444013|NCT03580369|144401826|SUPERIORITY||LS Mean|-3.1|STANDARD_ERROR_OF_MEAN|0.597|<|0.0001|TWO_SIDED|95.0|-4.271|-1.929|||Mixed Models Analysis|Linear mixed model with repeated measures (MMRM)||Adults||-1.929|-4.271|<.0001
72444014|NCT03580369|144401826|SUPERIORITY||LS Mean|0.419|STANDARD_ERROR_OF_MEAN|0.428||0.8366|TWO_SIDED|95.0|-0.419|1.258|||Mixed Models Analysis|Linear mixed model with repeated measures (MMRM)||Adults||1.258|-0.419|0.8366
72444015|NCT03580369|144401826|SUPERIORITY|Adults|LS Mean|-3.13|STANDARD_ERROR_OF_MEAN|0.594|<|0.0001|TWO_SIDED|95.0|-4.295|-1.966|||Mixed Models Analysis|Linear mixed model with repeated measures (MMRM)||||-1.966|-4.295|<.0001
72444016|NCT03580369|144401826|SUPERIORITY||LS Mean|0.389|STANDARD_ERROR_OF_MEAN|0.425||0.8201|TWO_SIDED|95.0|-0.444|1.222|||Mixed Models Analysis|Linear mixed model with repeated measures (MMRM)||Adults||1.222|-0.444|0.8201
72444017|NCT03580369|144401828|SUPERIORITY|Wald chi-square test based on logistic regression|Odds Ratio (OR)|2.747|||<|0.0001|TWO_SIDED|95.0|1.621|4.656|||Regression, Logistic|95% confidence interval for the odds ratio||Adults||4.656|1.621|<.0001
72444018|NCT03580369|144401828|SUPERIORITY|Wald chi-square test based on logistic regression|Odds Ratio (OR)|0.836||||0.8586|TWO_SIDED|95.0|0.603|1.159|||Regression, Logistic|95% confidence interval for the odds ratio||Adults||1.159|0.603|0.8586
72444019|NCT03580369|144401828|SUPERIORITY|Wald chi-square test based on logistic regression|Odds Ratio (OR)|3.261|||<|0.0001|TWO_SIDED|95.0|1.929|5.513|||Regression, Logistic|95% confidence interval for the odds ratio||Adults||5.513|1.929|<.0001
72444020|NCT03580369|144401828|SUPERIORITY|Wald chi-square test based on logistic regression|Odds Ratio (OR)|0.992||||0.519|TWO_SIDED|95.0|0.717|1.373|||Regression, Logistic|95% confidence interval for the odds ratio||Adults||1.373|0.717|0.5190
72444021|NCT03580369|144401829|SUPERIORITY||Risk Ratio (RR)|1.323|||<|0.0001|TWO_SIDED|95.0|1.183|1.48|||Negative binomial regression model|95% confidence interval for the relative risk ratio||Adults||1.480|1.183|<.0001
72444022|NCT03580369|144401829|SUPERIORITY||Risk Ratio (RR)|0.975||||0.7469|TWO_SIDED|95.0|0.904|1.051|||Negative binomial regression model|95% confidence interval for the relative risk ratio||Adults||1.051|0.904|0.7469
72444023|NCT03580369|144401829|SUPERIORITY||Risk Ratio (RR)|1.376|||<|0.0001|TWO_SIDED|95.0|1.23|1.54|||Negative binomial regression model|95% confidence interval for the relative risk ratio||Adults||1.540|1.230|<.0001
72444024|NCT03580369|144401829|SUPERIORITY||Risk Ratio (RR)|1.014||||0.3586|TWO_SIDED|95.0|0.941|1.092|||Negative binomial regression model|95% confidence interval for the relative risk ratio||Adults||1.092|0.941|0.3586
72444025|NCT04455035|144401900|OTHER|ttest||||||0.0088|||||||t-test, 2 sided|||||||0.0088
72444026|NCT04455035|144401901|OTHER|ttest||||||1e-05|||||||t-test, 2 sided|||||||0.00001
72444027|NCT04970407|144401937|SUPERIORITY||Treatment difference|-1.16||||0.8769|TWO_SIDED|95.0|-16.25|13.93|||MMRM model|||The adjusted mean, standard error (SE) and 95% confidence interval (CI) of the adjusted mean as well as difference in % relative to baseline and p-value were obtained from a MMRM with Fisher scoring with treatment, time (corresponding to all study visits when CMAP was measured), treatment by time interaction and baseline CMAP amplitude as factors and an unstructured variance covariance matrix.||13.93|-16.25|0.8769
72444028|NCT04970407|144401937|SUPERIORITY||Treatment difference|-10.61||||0.162|TWO_SIDED|95.0|-25.69|4.47|||MMRM model|||The adjusted mean, SE and 95% CI of the adjusted mean as well as difference in % relative to baseline and p-value were obtained from a MMRM with Fisher scoring with treatment, time (corresponding to all study visits when CMAP was measured), treatment by time interaction and baseline CMAP amplitude as factors and an unstructured variance covariance matrix.||4.47|-25.69|0.1620
72444029|NCT04788537|144401963|SUPERIORITY|Linear mixed model regression|Slope|-1.58||||0.006|TWO_SIDED||||||Mixed Models Analysis||Slope reported is for Time x Group Interaction|||||.006
72444030|NCT02815813|144401964|SUPERIORITY||||||<|0.01|||||||GLMM|||||||<0.01
72444031|NCT02815813|144401965|SUPERIORITY||||||<|0.01|||||||GLMM|||||||<0.01
72444032|NCT04899115|144401985|SUPERIORITY|||||||0.13|||||||t-test, 2 sided|||||||0.13
72444033|NCT04899115|144401986|SUPERIORITY|||||||0.48|||||||Wilcoxon (Mann-Whitney)|Wilcoxon was used because data was not normal.||||||0.48
72444034|NCT03743636|144402002|SUPERIORITY||Mean Difference (Final Values)|17.57||||0.0775|ONE_SIDED|90.0|1.77||||Mixed Models Analysis||||||1.77|0.0775
72444035|NCT03743636|144402003|SUPERIORITY||Mean Difference (Final Values)|3.65||||0.3762|ONE_SIDED|90.0|-11.24||||Mixed Models Analysis||||||-11.24|0.3762
72497181|NCT02649634|144524185|NON_INFERIORITY_OR_EQUIVALENCE|Estimated sample size needed was 90 (45/group). This was based on a sample size calculation for 2 groups with 0.05 alpha, 0.80 power, anticipating a medium effect size.|||||>|0.05||||||Significance threshold is p=.05|t-test, 2 sided|||Self-efficacy was analyzed via an independent sample t-test comparing the groups on mean global self efficacy rating on the WEL.||||>.05
72497182|NCT02649634|144524186|NON_INFERIORITY_OR_EQUIVALENCE|Estimated sample size needed was 90 (45/group). This was based on a sample size calculation for 2 groups with 0.05 alpha, 0.80 power, anticipating a medium effect size.|||||>|0.05||||||Significance threshold is p=.05|t-test, 2 sided|||Self-efficacy was analyzed via an independent sample t-test comparing the groups on mean self efficacy rating on the ESE.||||>.05
72497183|NCT02649634|144524187|NON_INFERIORITY_OR_EQUIVALENCE|Estimated sample size needed was 90 (45/group). This was based on a sample size calculation for 2 groups with 0.05 alpha, 0.80 power, anticipating a medium effect size.|||||>|0.05||||||Significance threshold is p=.05|t-test, 2 sided|||Importance of Change ratings were analyzed via an independent sample t-test comparing the groups on mean Importance of Change ratings on the 11-point visual analogue scales||||>.05
72497184|NCT02649634|144524188|NON_INFERIORITY_OR_EQUIVALENCE|Estimated sample size needed was 90 (45/group). This was based on a sample size calculation for 2 groups with 0.05 alpha, 0.80 power, anticipating a medium effect size.|||||>|0.05||||||Significance threshold is p=.05|t-test, 2 sided|||Readiness for Change ratings were analyzed via an independent sample t-test comparing the groups on mean Readiness for Change ratings on the 11-point visual analogue scales||||>.05
72497185|NCT02649634|144524189|NON_INFERIORITY_OR_EQUIVALENCE|Estimated sample size needed was 90 (45/group). This was based on a sample size calculation for 2 groups with 0.05 alpha, 0.80 power, anticipating a medium effect size.|||||>|0.05||||||Significance threshold is p=.05|t-test, 2 sided|||Confidence for Change ratings were analyzed via an independent sample t-test comparing the groups on mean Confidence for Change ratings on the 11-point visual analogue scales||||>.05
72497186|NCT02649634|144524190|NON_INFERIORITY_OR_EQUIVALENCE|Estimated sample size needed was 90 (45/group). This was based on a sample size calculation for 2 groups with 0.05 alpha, 0.80 power, anticipating a medium effect size.|||||>|0.05||||||Significance threshold is p=.05|t-test, 2 sided|||Importance of Change ratings were analyzed via an independent sample t-test comparing the groups on mean Importance of Change ratings on the 11-point visual analogue scales||||>.05
72497187|NCT02649634|144524191|NON_INFERIORITY_OR_EQUIVALENCE|Estimated sample size needed was 90 (45/group). This was based on a sample size calculation for 2 groups with 0.05 alpha, 0.80 power, anticipating a medium effect size.|||||>|0.05||||||Significance threshold is p=.05|t-test, 2 sided|||Readiness for Change ratings were analyzed via an independent sample t-test comparing the groups on mean Readiness for Change ratings on the 11-point visual analogue scales||||>.05
72560208|NCT01943435|144651123|SUPERIORITY||Mean Difference (Final Values)|18.7||||0.16|TWO_SIDED|95.0|-7.6|45.0|||Regression, Linear|Linear mixed models were adjusted for randomization stratification factors.||This secondary analysis consisted of a between-groups comparison of means using linear regression with physical activity as the dependent variable (average number of minutes spent daily in activities \>1.5 METs), while adjusting for randomization stratification factors.||45.0|-7.6|0.16
72560209|NCT01943435|144651123|SUPERIORITY||Mean Difference (Final Values)|11.8||||0.4|TWO_SIDED|95.0|-15.6|39.1|||Regression, Linear|Linear mixed models were adjusted for randomization stratification factors.||This secondary analysis consisted of a between-groups comparison of means using linear regression with physical activity as the dependent variable (average number of minutes spent daily in activities \>1.5 METs), while adjusting for randomization stratification factors.||39.1|-15.6|0.40
72497188|NCT02649634|144524192|NON_INFERIORITY_OR_EQUIVALENCE|Estimated sample size needed was 90 (45/group). This was based on a sample size calculation for 2 groups with 0.05 alpha, 0.80 power, anticipating a medium effect size.|||||>|0.05||||||Significance threshold is p=.05|t-test, 2 sided|||Confidence for Change ratings were analyzed via an independent sample t-test comparing the groups on mean Confidence for Change ratings on the 11-point visual analogue scales||||>.05
72497189|NCT01486199|144524193|EQUIVALENCE|alpha=0.05||||||0.002|||||||t-test, 2 sided|||Comparing absorptive clearance in CF children vs adult controls||||0.002
72497190|NCT01486199|144524194|EQUIVALENCE|alpha = 0.05||||||0.2|||||||t-test, 2 sided|||Comparison of mucociliary clearance in CF children compared to healthy adults||||0.20
72497191|NCT01486199|144524195|EQUIVALENCE|alpha=0.05||||||0.24|||||||Wilcoxon (Mann-Whitney)|||Comparing absorptive clearance at t=0 vs t=2 years in pediatric CF subjects||||0.24
72497192|NCT01486199|144524196|EQUIVALENCE|alpha=0.05||||||0.87|||||||Wilcoxon (Mann-Whitney)|||Comparing mucociliary clearance at t=0 and t=2yrs in pediatric CF subjects||||0.87
72497193|NCT02211261|144524220|OTHER||Percentage of Test relative to Reference|17.66|||||TWO_SIDED|90.0|8.44|36.95|||||PF-06293620 0.3 mg/kg SC (SAD Cohorts) is Test, PF-06293620 1.0 mg/kg IV (SAD Cohorts) is Reference.|||36.95|8.44|
72497194|NCT02211261|144524220|OTHER||Percentage of Test relative to Reference|32.73|||||TWO_SIDED|90.0|21.64|49.51|||||PF-06293620 1.0 mg/kg SC (SAD Cohorts) is Test, PF-06293620 1.0 mg/kg IV (SAD Cohorts) is Reference.|||49.51|21.64|
72560210|NCT01559116|144651143|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.28|STANDARD_ERROR_OF_MEAN|0.014|<|0.0001|TWO_SIDED|95.0|0.252|0.309|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Placebo is calculated.|||0.309|0.252|<0.0001
72560211|NCT01559116|144651143|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.115|STANDARD_ERROR_OF_MEAN|0.014|<|0.0001|TWO_SIDED|95.0|0.087|0.143|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Olodaterol (5 µg) is calculated.|||0.143|0.087|<0.0001
72619167|NCT03016403|144769035|SUPERIORITY||Mean Difference (Final Values)|-4.16||||0.0134|TWO_SIDED|95.0|-7.45|-0.87||Since there are three primary outcomes (depression, anxiety and coping scores) in the study, the significance level was set a priori at 0.0167 (alpha = 0.05/3).|Mixed Models Analysis|The pvalue corresponds to the hypothesis of the interaction effect between time and group (intervention arm).|The estimate represents the difference in expected means at the 6-month time point between the intervention and usual care arms.|A linear mixed model (LMM) with random intercepts for both patients and clinics has been used, with adjustment for cancer type and cancer stage. The study was powered for testing the hypothesis of no group differences in change over the four time points (baseline, 6-weeks, 3-months and 6-months). A significant group by time interaction was hypothesized.||-0.87|-7.45|0.0134
72444036|NCT03743636|144402004|SUPERIORITY||Mean Difference (Final Values)|22.42||||0.0294|ONE_SIDED|90.0|7.31||||Mixed Models Analysis||||||7.31|0.0294
72444037|NCT03743636|144402005|SUPERIORITY||Mean Difference (Final Values)|20.63||||0.0336|ONE_SIDED|90.0|6.26||||Mixed Models Analysis||||||6.26|0.0336
72444038|NCT03743636|144402006|SUPERIORITY||Mean Difference (Final Values)|-1.78||||0.562|ONE_SIDED|90.0|-16.51||||Mixed Models Analysis||||||-16.51|0.5620
72444039|NCT03743636|144402007|SUPERIORITY||Mean Difference (Final Values)|-13.93||||0.8797|ONE_SIDED|90.0|-29.15||||Mixed Models Analysis||||||-29.15|0.8797
72444040|NCT03743636|144402008|SUPERIORITY||Mean Difference (Final Values)|2.06||||0.0752|ONE_SIDED|90.0|0.24||||ANCOVA||||||0.24|0.0752
72444041|NCT03743636|144402009|SUPERIORITY||Mean Difference (Final Values)|-7.1||||0.8703|ONE_SIDED|90.0|-15.19||||ANCOVA||||||-15.19|0.8703
72444042|NCT03743636|144402010|SUPERIORITY||Mean Difference (Final Values)|10995.0||||0.1402|ONE_SIDED|90.0|-2078.0||||ANCOVA||||||-2078|0.1402
72444043|NCT03743636|144402011|SUPERIORITY||Mean Difference (Final Values)|1.74||||0.1249|ONE_SIDED|90.0|-0.21||||ANCOVA||||||-0.21|0.1249
72497195|NCT02211261|144524220|OTHER||Percentage of Test relative to Reference|35.02|||||TWO_SIDED|90.0|23.6|51.95|||||PF-06293620 3.0 mg/kg SC (SAD Cohorts) is Test, PF-06293620 1.0 mg/kg IV (SAD Cohorts) is Reference.|||51.95|23.60|
72497196|NCT02211261|144524220|OTHER||Percentage of Test relative to Reference|53.18|||||TWO_SIDED|90.0|36.36|77.78|||||PF-06293620 6.0 mg/kg SC (SAD Cohorts) is Test, PF-06293620 1.0 mg/kg IV (SAD Cohorts) is Reference.|||77.78|36.36|
72497197|NCT02211261|144524222|OTHER||Percentage of Test relative to Reference|7.32|||||TWO_SIDED|90.0|4.7|11.4|||||PF-06293620 0.3 mg/kg SC (SAD Cohorts) is Test, PF-06293620 1.0 mg/kg IV (SAD Cohorts) is Reference.|||11.40|4.70|
72497198|NCT02211261|144524222|OTHER||Percentage of Test relative to Reference|32.19|||||TWO_SIDED|90.0|20.67|50.12|||||PF-06293620 1.0 mg/kg SC (SAD Cohorts) is Test, PF-06293620 1.0 mg/kg IV (SAD Cohorts) is Reference.|||50.12|20.67|
72497199|NCT02211261|144524222|OTHER||Percentage of Test relative to Reference|34.43|||||TWO_SIDED|90.0|22.57|52.52|||||PF-06293620 3.0 mg/kg SC (SAD Cohorts) is Test, PF-06293620 1.0 mg/kg IV (SAD Cohorts) is Reference.|||52.52|22.57|
72497200|NCT02211261|144524222|OTHER||Percentage of Test relative to Reference|51.47|||||TWO_SIDED|90.0|34.26|77.31|||||PF-06293620 6.0 mg/kg SC (SAD Cohorts) is Test, PF-06293620 1.0 mg/kg IV (SAD Cohorts) is Reference.|||77.31|34.26|
72497201|NCT01078805|144524247|SUPERIORITY_OR_OTHER|||||||0.0177||95.0||||Comparison is between 0 to 6 months fracture incidence rate versus 6 to 12 months fracture incidence rate.|One-sample binomial proportion test|||||||0.0177
72497202|NCT01078805|144524247|SUPERIORITY_OR_OTHER|||||||0.0019||95.0||||Comparison is between 0 to 6 months fracture incidence rate versus 12 to 18 months fracture incidence rate.|One-sample binomial proportion test|||||||0.0019
72497203|NCT01078805|144524247|SUPERIORITY_OR_OTHER|||||||0.0143||95.0||||Comparison is between 0 to 6 months fracture incidence rate versus 18 to 24 months fracture incidence rate.|One-sample binomial proportion test|||||||0.0143
72444044|NCT03743636|144402012|SUPERIORITY||Mean Difference (Final Values)|-5.05||||0.8039|ONE_SIDED|90.0|-12.62||||ANCOVA||||||-12.62|0.8039
72444045|NCT03743636|144402013|SUPERIORITY||Mean Difference (Final Values)|-842.0||||0.5352|ONE_SIDED|90.0|-13125.0||||ANCOVA||||||-13125|0.5352
72444046|NCT03743636|144402014|SUPERIORITY||Mean Difference (Final Values)|-0.32||||0.5777|ONE_SIDED|90.0|-2.46||||ANCOVA||||||-2.46|0.5777
72444047|NCT03743636|144402015|SUPERIORITY||Mean Difference (Final Values)|2.06||||0.3662|ONE_SIDED|90.0|-5.69||||ANCOVA||||||-5.69|0.3662
72444048|NCT03743636|144402016|SUPERIORITY||Mean Difference (Final Values)|-11837.0||||0.8866|ONE_SIDED|90.0|-24396.0||||ANCOVA||||||-24396|0.8866
72444049|NCT03743636|144402017|SUPERIORITY|Mixed model for repeated measures is applied to Placebo vs. 2 NR groups combined. The reported results of within group change and between group difference are Least Squares Mean (Standard Error) from the model adjusted for baseline six-minute walk + age + sex + race + resveratrol usage.|Mean Difference (Final Values)|25.25||||0.0153|ONE_SIDED|90.0|10.43|||The a priori statistical analysis plan defined a one-sided P value of \< 0.10 to define statistical significance.|Mixed Models Analysis|||Mixed models for repeated measures were used to compare 3-month change in 6MW distance between the NR/resveratrol vs placebo groups and between the NR alone vs placebo groups using baseline, 3-month, and 6-month values, adjusted for age, sex, race, and baseline 6MW.|||10.43|0.0153
72444050|NCT03743636|144402018|SUPERIORITY|Mixed model for repeated measures is applied to Placebo vs. 2 NR groups combined. The reported results of within group change and between group difference are Least Squares Mean (Standard Error) from the model adjusted for baseline six-minute walk + age + sex + race + resveratrol usage.|Mean Difference (Final Values)|14.05||||0.1195|ONE_SIDED|90.0|-1.25||||Mixed Models Analysis|||Mixed models for repeated measures were used to compare 6-month change in 6MW distance between the NR/resveratrol vs placebo groups and between the NR alone vs placebo groups using baseline, 3-month, and 6-month values, adjusted for age, sex, race, and baseline 6MW.|||-1.25|0.1195
72444051|NCT03743636|144402019|SUPERIORITY||Mean Difference (Final Values)|2.06||||0.0752|ONE_SIDED|90.0|0.24|||The a priori statistical analysis plan defined a one-sided P value of \< 0.10 to define statistical significance.|ANCOVA|||Mixed model for repeated measures is applied to Placebo vs. 2 NR groups combined. The reported results of within group change and between group difference are Least Squares Mean (Standard Error) from the model adjusted for baseline six-minute walk + age + sex + race + resveratrol usage.|||0.24|0.0752
72444052|NCT03743636|144402020|SUPERIORITY||Mean Difference (Final Values)|-7.1||||0.8703|ONE_SIDED|90.0|-15.19||||ANCOVA|||Mixed model for repeated measures is applied to Placebo vs. 2 NR groups combined. The reported results of within group change and between group difference are Least Squares Mean (Standard Error) from the model adjusted for baseline six-minute walk + age + sex + race + resveratrol usage.|||-15.19|0.8703
72444053|NCT03743636|144402021|SUPERIORITY||Mean Difference (Final Values)|10995.0||||0.1402|ONE_SIDED|90.0|-2078.0||||ANCOVA|||Mixed model for repeated measures is applied to Placebo vs. 2 NR groups combined. The reported results of within group change and between group difference are Least Squares Mean (Standard Error) from the model adjusted for baseline six-minute walk + age + sex + race + resveratrol usage.|||-2078|0.1402
72444054|NCT03743636|144402022|SUPERIORITY||Mean Difference (Final Values)|-35.13||||0.8401|ONE_SIDED|90.0|-81.2||||ANCOVA||||||-81.20|0.8401
72444055|NCT03743636|144402023|SUPERIORITY||Mean Difference (Final Values)|11.14||||0.0602|ONE_SIDED|90.0|2.16||||ANCOVA|||Mixed model for repeated measures is applied to Placebo vs. 2 NR groups combined. The reported results of within group change and between group difference are Least Squares Mean (Standard Error) from the model adjusted for baseline six-minute walk + age + sex + race + resveratrol usage.|||2.16|0.0602
72444056|NCT03743636|144402024|SUPERIORITY||Mean Difference (Final Values)|5.21||||0.2378|ONE_SIDED|90.0|-4.47||||ANCOVA||||||-4.47|0.2378
72619168|NCT03016403|144769036|SUPERIORITY||Mean Difference (Final Values)|0.61||||0.42|TWO_SIDED|95.0|-0.9|2.12||Since there are three primary outcomes (depression, anxiety and coping scores) in the study, the significance level was set a priori at 0.0167 (alpha = 0.05/3).|Mixed Models Analysis|The pvalue corresponds to the hypothesis of the interaction effect between time and group (intervention arm).|The estimate represents the difference in expected means at the 6-month time point between the intervention and usual care arms.|A linear mixed model (LMM) with random intercepts for both patients and clinics has been used, with adjustment for cancer type and cancer stage. The study was powered for testing the hypothesis of no group differences in change over the four time points (baseline, 6-weeks, 3-months and 6-months). A significant group by time interaction was hypothesized.||2.12|-0.9|0.42
72444057|NCT03743636|144402025|SUPERIORITY||Mean Difference (Final Values)|6.05||||0.1589|ONE_SIDED|90.0|-1.86||||ANCOVA|||Mixed model for repeated measures is applied to 3 groups comparisons. The reported results of within group change and between group difference are Least Squares Mean (Standard Error) from the model adjusted for baseline six-minute walk + age + sex + race + resveratrol usage.|||-1.86|0.1589
72444058|NCT03743636|144402025|SUPERIORITY||Mean Difference (Final Values)|11.14||||0.0602|ONE_SIDED|90.0|2.16||||ANCOVA|||Mixed model for repeated measures is applied to 3 groups comparisons. The reported results of within group change and between group difference are Least Squares Mean (Standard Error) from the model adjusted for baseline six-minute walk + age + sex + race + resveratrol usage.|||2.16|0.0602
72444059|NCT03743636|144402026|SUPERIORITY||Mean Difference (Final Values)|10.25||||0.3724|ONE_SIDED|90.0|-31.79||||ANCOVA|||Mixed model for repeated measures is applied to 3 groups comparisons. The reported results of within group change and between group difference are Least Squares Mean (Standard Error) from the model adjusted for baseline six-minute walk + age + sex + race + resveratrol usage.|||-31.79|0.3724
72444060|NCT03743636|144402026|SUPERIORITY||Mean Difference (Final Values)|-35.13||||0.8401|ONE_SIDED|90.0|-81.2||||ANCOVA|||Mixed model for repeated measures is applied to 3 groups comparisons. The reported results of within group change and between group difference are Least Squares Mean (Standard Error) from the model adjusted for baseline six-minute walk + age + sex + race + resveratrol usage.|||-81.20|0.8401
72444061|NCT03743636|144402027|SUPERIORITY||Mean Difference (Final Values)|-0.9||||0.5558|ONE_SIDED|90.0|-9.52||||ANCOVA|||Mixed model for repeated measures is applied to 3 groups comparisons. The reported results of within group change and between group difference are Least Squares Mean (Standard Error) from the model adjusted for baseline six-minute walk + age + sex + race + resveratrol usage.|||-9.52|0.5558
72444062|NCT03743636|144402027|SUPERIORITY||Mean Difference (Final Values)|5.21||||0.2378|ONE_SIDED|90.0|-4.47||||ANCOVA|||Mixed model for repeated measures is applied to 3 groups comparisons. The reported results of within group change and between group difference are Least Squares Mean (Standard Error) from the model adjusted for baseline six-minute walk + age + sex + race + resveratrol usage.|||-4.47|0.2378
72444063|NCT03743636|144402028|SUPERIORITY||Mean Difference (Final Values)|-2.71||||0.7112|ONE_SIDED|90.0|-8.97||||ANCOVA||||||-8.97|0.7112
72444064|NCT03743636|144402029|SUPERIORITY||Mean Difference (Final Values)|-7.4||||0.9449|ONE_SIDED|90.0|-13.31||||ANCOVA||||||-13.31|0.9449
72444065|NCT03743636|144402030|SUPERIORITY||Mean Difference (Final Values)|-0.48||||0.5409|ONE_SIDED|90.0|-6.57||||ANCOVA||||||-6.57|0.5409
72444066|NCT03743636|144402031|SUPERIORITY||Mean Difference (Final Values)|-3.35||||0.7814|ONE_SIDED|90.0|-8.89||||ANCOVA||||||-8.89|0.7814
72444067|NCT03743636|144402032|SUPERIORITY||Mean Difference (Final Values)|-1.04||||0.5884|ONE_SIDED|90.0|-7.07||||ANCOVA||||||-7.07|0.5884
72444068|NCT03743636|144402033|SUPERIORITY||Mean Difference (Final Values)|4.05||||0.1787|ONE_SIDED|90.0|-1.6||||ANCOVA||||||-1.60|0.1787
72444069|NCT03743636|144402034|SUPERIORITY||Mean Difference (Final Values)|-2.71||||0.7112|ONE_SIDED|90.0|-8.97||||ANCOVA|||Mixed model for repeated measures is applied to Placebo vs. 2 NR groups combined. The reported results of within group change and between group difference are Least Squares Mean (Standard Error) from the model adjusted for baseline six-minute walk + age + sex + race + resveratrol usage.|||-8.97|0.7112
72444070|NCT03743636|144402035|SUPERIORITY||Mean Difference (Final Values)|-7.4||||0.9449|ONE_SIDED|90.0|-13.31||||ANCOVA|||Mixed model for repeated measures is applied to Placebo vs. 2 NR groups combined. The reported results of within group change and between group difference are Least Squares Mean (Standard Error) from the model adjusted for baseline six-minute walk + age + sex + race + resveratrol usage.|||-13.31|0.9449
72444071|NCT03467542|144402092|OTHER||||||||||||||||||The total number evaluated, the percent, and the Clopper-Pearson two-sided 95% confidence limits on the percent.|||
72444072|NCT05387447|144402104|OTHER|||||||0.05|||||||Z score|||||||.05
72444073|NCT05387447|144402105|OTHER|||||||0.05|||||||Z score|||||||.05
72444074|NCT05387447|144402107|OTHER|||||||0.05|||||||Z score|||||||.05
72444075|NCT05387447|144402108|OTHER|||||||0.05|||||||Z score|||||||.05
72444076|NCT04640961|144402169|OTHER||||||<|0.0001||||||P-Value was calculated|ANOVA|||||||<0.0001
72444077|NCT04640961|144402170|OTHER||||||<|0.0001||||||P-Value was calculated|ANOVA|||||||<0.0001
72444078|NCT04640961|144402171|OTHER||||||<|0.0001||||||P-Value was calculated|ANOVA|||||||<0.0001
72469440|NCT04750577|144462631|OTHER||Mean Difference (Net)|-0.103||||0.3224|TWO_SIDED|95.0|-0.309|0.102|||Mixed-effect Model Repeat Measurement||"Least Squares Mean of 1 mg BI 685509 TID- Least Squares Mean ofPlacebo"|Least Square Means difference and 95% confidence interval were estimated by restricted maximum likelihood based Mixed-effect Model for Repeated Measures ((REML)-based MMRM) including the fixed, categorical effects of treatment at each visit (baseline, Week 6, Week 12 and Week 20), and the continuous effect of baseline at each visit (Week 6, Week 12 and Week 20) as well as random effects of patient.||0.102|-0.309|0.3224
72497204|NCT01078805|144524248|SUPERIORITY_OR_OTHER|||||||0.0689||95.0||||Comparison is between 0 to 6 months fracture incidence rate versus 6 to 12 months fracture incidence rate.|One-sample binomial proportion test|||||||0.0689
72497205|NCT01078805|144524248|SUPERIORITY_OR_OTHER|||||||0.0412||95.0||||Comparison is between 0 to 6 months fracture incidence rate versus 12 to 18 months fracture incidence rate.|One-sample binomial proportion test|||||||0.0412
72497206|NCT01078805|144524248|SUPERIORITY_OR_OTHER|||||||0.0631||95.0||||Comparison is between 0 to 6 months fracture incidence rate versus 18 to 24 months fracture incidence rate.|One-sample binomial proportion test|||||||0.0631
72497207|NCT01078805|144524249|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||||||<0.001
72444079|NCT03052608|144402174|SUPERIORITY||Hazard Ratio (HR)|0.28|||<|0.0001|TWO_SIDED|95.0|0.191|0.413||The study was to be considered positive if the 1-sided log-rank test for PFS, stratified for baseline stratification factors (ethnicity and brain metastases) was significant at the 0.0081 level at the cutoff date of this report.|one-sided stratified log-rank|Stratified by the presence of brain metastases (Yes/No) and ethnic origin (Asian/Non-Asian) at randomization.|Based on Cox Proportional Hazards model stratified by the presence of brain metastases and ethnic origin at randomization. Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of Lorlatinib.|The study was designed to test the null hypothesis H0: λ ≥1 versus the alternative hypothesis HA: λ \<1, where λ is the hazard ratio (HR; Lorlatinib/Crizotinib). Evaluation of 177 PFS events was required to have at least 90% power to detect a HR of 0.611 using a one-sided stratified log-rank test at a significance level of 0.025 (one-sided), and a 2-look group-sequential design with a Lan-DeMets (O'Brien-Fleming) α-spending function to determine the efficacy boundaries.||0.413|0.191|<0.0001
72444080|NCT03052608|144402175|SUPERIORITY||Hazard Ratio (HR)|0.72|||||TWO_SIDED|95.0|0.414|1.249|||||Based on Cox Proportional Hazards model stratified by the presence of brain metastases and ethnic origin at randomization. Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of Lorlatinib.|||1.249|0.414|
72444081|NCT03052608|144402176|SUPERIORITY||Hazard Ratio (HR)|0.21|||<|0.0001|TWO_SIDED|95.0|0.144|0.307|||one-sided stratified log-rank|Stratified by the presence of brain metastases (Yes/No) and ethnic origin (Asian/Non-Asian) at randomization.|Based on Cox Proportional Hazards model stratified by the presence of brain metastases and ethnic origin at randomization. Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of Lorlatinib.|||0.307|0.144|<0.0001
72444082|NCT03052608|144402177|SUPERIORITY||Odds Ratio (OR)|2.254||||0.0005|TWO_SIDED|95.0|1.353|3.891|||Cochran-Mantel-Haenszel|Stratified by the presence of brain metastases (Yes/No) and ethnic origin (Asian/Non-Asian) at randomization.|Odds ratio was estimated using Mantel-Haenszel method. An odds ratio larger than 1 indicates better outcome for Lorlatinib relative to Crizotinib. Exact CI was calculated.|||3.891|1.353|0.0005
72444083|NCT03052608|144402178|SUPERIORITY||Odds Ratio (OR)|2.499||||0.0002|TWO_SIDED|95.0|1.484|4.594|||Cochran-Mantel-Haenszel|Stratified by the presence of brain metastases (Yes/No) and ethnic origin (Asian/Non-Asian) at randomization.|Odds ratio was estimated using Mantel-Haenszel method. An odds ratio larger than 1 indicates better outcome for Lorlatinib relative to Crizotinib. Exact CI was calculated.|||4.594|1.484|0.0002
72444084|NCT03052608|144402179|SUPERIORITY||Odds Ratio (OR)|8.407|||<|0.0001|TWO_SIDED|95.0|2.586|27.233|||Cochran-Mantel-Haenszel|Stratified by the presence of brain metastases (Yes/No) and ethnic origin (Asian/Non-Asian) at randomization.|Odds ratio was estimated using Mantel-Haenszel method. An odds ratio larger than 1 indicates better outcome for Lorlatinib relative to Crizotinib. Exact CI was calculated.|||27.233|2.586|<0.0001
72444085|NCT03052608|144402180|SUPERIORITY||Hazard Ratio (HR)|0.07|||<|0.0001|TWO_SIDED|95.0|0.026|0.17|||one-sided stratified log-rank|Stratified by the presence of brain metastases (Yes/No) and ethnic origin (Asian/Non-Asian) at randomization.|Based on Cox Proportional Hazards model stratified by the presence of brain metastases and ethnic origin at randomization. Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of Lorlatinib.|||0.170|0.026|<0.0001
72497208|NCT01078805|144524250|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||||||<0.001
72497209|NCT03694392|144524269|OTHER||Hazard Ratio (HR)|0.85|||<|0.05|TWO_SIDED|95.0|0.76|0.94||Adjustment for multiplicity for the secondary outcomes was performed with the use of Holm's adjustment method.|Regression, Cox|Models were adjusted for age, age squared, sex, and race or ethnic group after weighting with stabilized facility-specific propensity scores.|Relative vaccine effectiveness (95% CI) calculated as 1 minus the hazard ratio, expressed as a percentage: 15.3% (5.9%, 23.8%)|||0.94|0.76|<0.05
72560212|NCT01559116|144651143|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.11|STANDARD_ERROR_OF_MEAN|0.014|<|0.0001|TWO_SIDED|95.0|0.082|0.139|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Tiotropium high dose (5 µg) is calculated.|||0.139|0.082|<0.0001
72560213|NCT01559116|144651143|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.277|STANDARD_ERROR_OF_MEAN|0.015|<|0.0001|TWO_SIDED|95.0|0.249|0.306|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to placebo is calculated.|||0.306|0.249|<0.0001
72560214|NCT01559116|144651143|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.111|STANDARD_ERROR_OF_MEAN|0.014|<|0.0001|TWO_SIDED|95.0|0.083|0.14|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Olodaterol (5 µg) is calculated.|||0.140|0.083|<0.0001
72444086|NCT03052608|144402195|SUPERIORITY||Mean Difference (Net)|4.65||||0.0096|TWO_SIDED|95.0|1.14|8.16|||Mixed Models Analysis|||This is the analysis for QLQ-C30 Global QOL. Estimated change from baseline was based on random intercept random slope mixed-effects model with an intercept term, treatment, time (as a continuous variable), treatment-by-time, baseline and randomization stratification factors as covariates.||8.16|1.14|0.0096
72497210|NCT03694392|144524270|OTHER||Hazard Ratio (HR)|0.84|||<|0.05|TWO_SIDED|95.0|0.65|1.09||Adjustment for multiplicity for the secondary outcomes was performed with the use of Holm's adjustment method.|Regression, Cox|Models were adjusted for age, age squared, sex, and race or ethnic group after weighting with stabilized facility-specific propensity scores.|Relative vaccine effectiveness (95% CI) calculated as 1 minus the hazard ratio, expressed as a percentage: 15.9% (-9.2% to 35.2%)|||1.09|0.65|<0.05
72497211|NCT03694392|144524271|OTHER||Hazard Ratio (HR)|0.83|||<|0.05|TWO_SIDED|95.0|0.66|1.06||Adjustment for multiplicity for the secondary outcomes was performed with the use of Holm's adjustment method.|Regression, Cox|Models were adjusted for age, age squared, sex, and race or ethnic group after weighting with stabilized facility-specific propensity scores.|Relative vaccine effectiveness (95% CI) calculated as 1 minus the hazard ratio, expressed as a percentage: 16.7% (-5.6% to 34.4%)|||1.06|0.66|<0.05
72444087|NCT03052608|144402195|SUPERIORITY||Mean Difference (Net)|2.02||||0.1897|TWO_SIDED|95.0|-1.01|5.05|||Mixed Models Analysis|||This is the analysis for QLQ-C30 Physical Functioning. Estimated change from baseline was based on random intercept random slope mixed-effects model with an intercept term, treatment, time (as a continuous variable), treatment-by-time, baseline and randomization stratification factors as covariates.||5.05|-1.01|0.1897
72444088|NCT03052608|144402195|SUPERIORITY||Mean Difference (Net)|2.09||||0.2999|TWO_SIDED|95.0|-1.87|6.04|||Mixed Models Analysis|||This is the analysis for QLQ-C30 Role Functioning. Estimated change from baseline was based on random intercept random slope mixed-effects model with an intercept term, treatment, time (as a continuous variable), treatment-by-time, baseline and randomization stratification factors as covariates.||6.04|-1.87|0.2999
72444089|NCT03052608|144402195|SUPERIORITY||Mean Difference (Net)|2.58||||0.0553|TWO_SIDED|95.0|-0.06|5.22|||Mixed Models Analysis|||This is the analysis for QLQ-C30 Emotional Functioning. Estimated change from baseline was based on random intercept random slope mixed-effects model with an intercept term, treatment, time (as a continuous variable), treatment-by-time, baseline and randomization stratification factors as covariates.||5.22|-0.06|0.0553
72444090|NCT03052608|144402195|SUPERIORITY||Mean Difference (Net)|-3.18||||0.0588|TWO_SIDED|95.0|-6.47|0.12|||Mixed Models Analysis|||This is the analysis for QLQ-C30 Cognitive Functioning. Estimated change from baseline was based on random intercept random slope mixed-effects model with an intercept term, treatment, time (as a continuous variable), treatment-by-time, baseline and randomization stratification factors as covariates.||0.12|-6.47|0.0588
72444091|NCT03052608|144402195|SUPERIORITY||Mean Difference (Net)|2.27||||0.2118|TWO_SIDED|95.0|-1.3|5.85|||Mixed Models Analysis|||This is the analysis for QLQ-C30 Social Functioning. Estimated change from baseline was based on random intercept random slope mixed-effects model with an intercept term, treatment, time (as a continuous variable), treatment-by-time, baseline and randomization stratification factors as covariates.||5.85|-1.30|0.2118
72560215|NCT01559116|144651143|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.124|STANDARD_ERROR_OF_MEAN|0.014|<|0.0001|TWO_SIDED|95.0|0.096|0.152|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Tiotropium low dose (2.5 µg) is calculated.|||0.152|0.096|<0.0001
72560216|NCT01559116|144651143|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.107|STANDARD_ERROR_OF_MEAN|0.014|<|0.0001|TWO_SIDED|95.0|0.079|0.136|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Tiotropium high dose (5 µg) is calculated.|||0.136|0.079|<0.0001
72560217|NCT01559116|144651144|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.319|STANDARD_ERROR_OF_MEAN|0.015|<|0.0001||95.0|0.289|0.349|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Placebo is calculated.|||0.349|0.289|<0.0001
72560218|NCT01559116|144651144|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.126|STANDARD_ERROR_OF_MEAN|0.015|<|0.0001|TWO_SIDED|95.0|0.096|0.156|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Olodaterol (5 µg) is calculated.|||0.156|0.096|<0.0001
72619169|NCT03016403|144769037|SUPERIORITY||Mean Difference (Final Values)|1.77||||0.0269|TWO_SIDED|95.0|0.2|3.34||Since there are three primary outcomes (depression, anxiety and coping scores) in the study, the significance level was set a priori at 0.0167 (alpha = 0.05/3).|Mixed Models Analysis|The pvalue corresponds to the hypothesis of the interaction effect between time and group (intervention arm).|The estimate represents the difference in expected means at the 6-month time point between the intervention and usual care arms.|A linear mixed model (LMM) with random intercepts for both patients and clinics has been used, with adjustment for cancer type and cancer stage. The study was powered for testing the hypothesis of no group differences in change over the four time points (baseline, 6-weeks, 3-months and 6-months). A significant group by time interaction was hypothesized.||3.34|0.2|0.0269
72444092|NCT03052608|144402195|SUPERIORITY||Mean Difference (Net)|-5.67||||0.0032|TWO_SIDED|95.0|-9.42|-1.92|||Mixed Models Analysis|||This is the analysis for QLQ-C30 Fatigue. Estimated change from baseline was based on random intercept random slope mixed-effects model with an intercept term, treatment, time (as a continuous variable), treatment-by-time, baseline and randomization stratification factors as covariates.||-1.92|-9.42|0.0032
72560219|NCT01559116|144651144|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.119|STANDARD_ERROR_OF_MEAN|0.015|<|0.0001|TWO_SIDED|95.0|0.089|0.149|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Tiotropium high dose (5 µg) is calculated.|||0.149|0.089|<0.0001
72560220|NCT01559116|144651144|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.323|STANDARD_ERROR_OF_MEAN|0.015|<|0.0001|TWO_SIDED|95.0|0.293|0.354|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Placebo is calculated.|||0.354|0.293|<0.0001
72560221|NCT01559116|144651144|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.131|STANDARD_ERROR_OF_MEAN|0.015|<|0.0001|TWO_SIDED|95.0|0.101|0.161|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Olodaterol (5 µg) is calculated.|||0.161|0.101|<0.0001
72560222|NCT01559116|144651144|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.139|STANDARD_ERROR_OF_MEAN|0.015|<|0.0001|TWO_SIDED|95.0|0.109|0.169|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Tiotropium low dose (2.5 µg) is calculated.|||0.169|0.109|<0.0001
72560223|NCT01559116|144651144|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.124|STANDARD_ERROR_OF_MEAN|0.015|<|0.0001|TWO_SIDED|95.0|0.093|0.154|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Tiotropium high dose (5 µg) is calculated.|||0.154|0.093|<0.0001
72560224|NCT01559116|144651145|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.243|STANDARD_ERROR_OF_MEAN|0.015|<|0.0001|TWO_SIDED|95.0|0.212|0.273|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Placebo is calculated.|||0.273|0.212|<0.0001
72444093|NCT03052608|144402195|SUPERIORITY||Mean Difference (Net)|-7.86|||<|0.0001|TWO_SIDED|95.0|-9.86|-5.86|||Mixed Models Analysis|||This is the analysis for QLQ-C30 Nausea and Vomiting. Estimated change from baseline was based on random intercept random slope mixed-effects model with an intercept term, treatment, time (as a continuous variable), treatment-by-time, baseline and randomization stratification factors as covariates.||-5.86|-9.86|<0.0001
72444094|NCT03052608|144402195|SUPERIORITY||Mean Difference (Net)|1.16||||0.531|TWO_SIDED|95.0|-2.49|4.82|||Mixed Models Analysis|||This is the analysis for QLQ-C30 Pain. Estimated change from baseline was based on random intercept random slope mixed-effects model with an intercept term, treatment, time (as a continuous variable), treatment-by-time, baseline and randomization stratification factors as covariates.||4.82|-2.49|0.5310
72444095|NCT03052608|144402195|SUPERIORITY||Mean Difference (Net)|1.72||||0.3602|TWO_SIDED|95.0|-1.98|5.43|||Mixed Models Analysis|||This is the analysis for QLQ-C30 Dyspnoea. Estimated change from baseline was based on random intercept random slope mixed-effects model with an intercept term, treatment, time (as a continuous variable), treatment-by-time, baseline and randomization stratification factors as covariates.||5.43|-1.98|0.3602
72444096|NCT03052608|144402195|SUPERIORITY||Mean Difference (Net)|-7.95|||<|0.0001|TWO_SIDED|95.0|-11.25|-4.64|||Mixed Models Analysis|||This is the analysis for QLQ-C30 Insomnia. Estimated change from baseline was based on random intercept random slope mixed-effects model with an intercept term, treatment, time (as a continuous variable), treatment-by-time, baseline and randomization stratification factors as covariates.||-4.64|-11.25|<0.0001
72444097|NCT03052608|144402195|SUPERIORITY||Mean Difference (Net)|-9.21|||<|0.0001|TWO_SIDED|95.0|-11.8|-6.62|||Mixed Models Analysis|||This is the analysis for QLQ-C30 Appetite Loss. Estimated change from baseline was based on random intercept random slope mixed-effects model with an intercept term, treatment, time (as a continuous variable), treatment-by-time, baseline and randomization stratification factors as covariates.||-6.62|-11.80|<0.0001
72444098|NCT03052608|144402195|SUPERIORITY||Mean Difference (Net)|-4.93||||0.0198|TWO_SIDED|95.0|-9.07|-0.79|||Mixed Models Analysis|||This is the analysis for QLQ-C30 Constipation. Estimated change from baseline was based on random intercept random slope mixed-effects model with an intercept term, treatment, time (as a continuous variable), treatment-by-time, baseline and randomization stratification factors as covariates.||-0.79|-9.07|0.0198
72444099|NCT03052608|144402195|SUPERIORITY||Mean Difference (Net)|-12.03|||<|0.0001|TWO_SIDED|95.0|-15.49|-8.58|||Mixed Models Analysis|||This is the analysis for QLQ-C30 Diarrhea. Estimated change from baseline was based on random intercept random slope mixed-effects model with an intercept term, treatment, time (as a continuous variable), treatment-by-time, baseline and randomization stratification factors as covariates.||-8.58|-15.49|<0.0001
72444100|NCT03052608|144402195|SUPERIORITY||Mean Difference (Net)|-1.04||||0.5947|TWO_SIDED|95.0|-4.9|2.82|||Mixed Models Analysis|||This is the analysis for QLQ-C30 Financial Difficulties. Estimated change from baseline was based on random intercept random slope mixed-effects model with an intercept term, treatment, time (as a continuous variable), treatment-by-time, baseline and randomization stratification factors as covariates.||2.82|-4.90|0.5947
72444101|NCT03052608|144402196|SUPERIORITY||Mean Difference (Net)|0.55||||0.7254|TWO_SIDED|95.0|-2.51|3.6|||Mixed Models Analysis|||This is the analysis for QLQ-LC13 Dyspnoea. Estimated change from baseline was based on random intercept random slope mixed-effects model with an intercept term, treatment, time (as a continuous variable), treatment-by-time, baseline and randomization stratification factors as covariates.||3.60|-2.51|0.7254
72444102|NCT03052608|144402196|SUPERIORITY||Mean Difference (Net)|-4.55||||0.0115|TWO_SIDED|95.0|-8.06|-1.03|||Mixed Models Analysis|||This is the analysis for QLQ-LC13 Coughing. Estimated change from baseline was based on random intercept random slope mixed-effects model with an intercept term, treatment, time (as a continuous variable), treatment-by-time, baseline and randomization stratification factors as covariates.||-1.03|-8.06|0.0115
72444103|NCT03052608|144402196|SUPERIORITY||Mean Difference (Net)|0.12||||0.7824|TWO_SIDED|95.0|-0.75|0.99|||Mixed Models Analysis|||This is the analysis for QLQ-LC13 Haemoptysis. Estimated change from baseline was based on random intercept random slope mixed-effects model with an intercept term, treatment, time (as a continuous variable), treatment-by-time, baseline and randomization stratification factors as covariates.||0.99|-0.75|0.7824
72444104|NCT03052608|144402196|SUPERIORITY||Mean Difference (Net)|1.16||||0.2988|TWO_SIDED|95.0|-1.04|3.36|||Mixed Models Analysis|||This is the analysis for QLQ-LC13 Sore Mouth. Estimated change from baseline was based on random intercept random slope mixed-effects model with an intercept term, treatment, time (as a continuous variable), treatment-by-time, baseline and randomization stratification factors as covariates.||3.36|-1.04|0.2988
72444105|NCT03052608|144402196|SUPERIORITY||Mean Difference (Net)|-1.51||||0.1916|TWO_SIDED|95.0|-3.79|0.76|||Mixed Models Analysis|||This is the analysis for QLQ-LC13 Dysphagia. Estimated change from baseline was based on random intercept random slope mixed-effects model with an intercept term, treatment, time (as a continuous variable), treatment-by-time, baseline and randomization stratification factors as covariates.||0.76|-3.79|0.1916
72444106|NCT03052608|144402196|SUPERIORITY||Mean Difference (Net)|5.37||||0.0279|TWO_SIDED|95.0|0.59|10.15|||Mixed Models Analysis|||This is the analysis for QLQ-LC13 Peripheral Neuropathy. Estimated change from baseline was based on random intercept random slope mixed-effects model with an intercept term, treatment, time (as a continuous variable), treatment-by-time, baseline and randomization stratification factors as covariates.||10.15|0.59|0.0279
72444107|NCT03052608|144402196|SUPERIORITY||Mean Difference (Net)|-0.2||||0.9162|TWO_SIDED|95.0|-3.89|3.49|||Mixed Models Analysis|||This is the analysis for QLQ-LC13 Alopecia. Estimated change from baseline was based on random intercept random slope mixed-effects model with an intercept term, treatment, time (as a continuous variable), treatment-by-time, baseline and randomization stratification factors as covariates.||3.49|-3.89|0.9162
72444108|NCT03052608|144402196|SUPERIORITY||Mean Difference (Net)|-0.53||||0.6698|TWO_SIDED|95.0|-2.96|1.9|||Mixed Models Analysis|||This is the analysis for QLQ-LC13 Pain in Chest. Estimated change from baseline was based on random intercept random slope mixed-effects model with an intercept term, treatment, time (as a continuous variable), treatment-by-time, baseline and randomization stratification factors as covariates.||1.90|-2.96|0.6698
72444109|NCT03052608|144402196|SUPERIORITY||Mean Difference (Net)|0.45||||0.8035|TWO_SIDED|95.0|-3.13|4.04|||Mixed Models Analysis|||This is the analysis for QLQ-LC13 Pain in Arm or Shoulder. Estimated change from baseline was based on random intercept random slope mixed-effects model with an intercept term, treatment, time (as a continuous variable), treatment-by-time, baseline and randomization stratification factors as covariates.||4.04|-3.13|0.8035
72560225|NCT01559116|144651145|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.103|STANDARD_ERROR_OF_MEAN|0.015|<|0.0001|TWO_SIDED|95.0|0.074|0.133|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Olodaterol (5 µg) is calculated.|||0.133|0.074|<0.0001
72389011|NCT01817530|144286172|SUPERIORITY||difference in LS means|-1.5|STANDARD_ERROR_OF_MEAN|2.58||0.556|TWO_SIDED|95.0|-6.65|3.59||P value for test of difference between each elagolix dose group and placebo at each post-baseline time point is from ANCOVA model with treatment as the main effect and baseline as covariate.|ANCOVA|||Final Month||3.59|-6.65|0.556
72389012|NCT01817530|144286172|SUPERIORITY||difference in LS means|-1.1|STANDARD_ERROR_OF_MEAN|2.63||0.672|TWO_SIDED|95.0|-6.33|4.09||P value for test of difference between each elagolix dose group and placebo at each post-baseline time point is from ANCOVA model with treatment as the main effect and baseline as covariate.|ANCOVA|||Final Month||4.09|-6.33|0.672
72389013|NCT01817530|144286172|SUPERIORITY||difference in LS means|3.0|STANDARD_ERROR_OF_MEAN|2.71||0.274|TWO_SIDED|95.0|-2.39|8.36||P value for test of difference between each elagolix dose group and placebo at each post-baseline time point is from ANCOVA model with treatment as the main effect and baseline as covariate.|ANCOVA|||Final Month||8.36|-2.39|0.274
72389014|NCT01817530|144286172|SUPERIORITY||difference in LS means|-2.0|STANDARD_ERROR_OF_MEAN|1.65||0.223|TWO_SIDED|95.0|-5.26|1.23||P value for test of difference between each elagolix dose group and placebo at each post-baseline time point is from ANCOVA model with treatment as the main effect and baseline as covariate.|ANCOVA|||Final Month||1.23|-5.26|0.223
72389015|NCT01817530|144286172|SUPERIORITY||difference in LS means|-2.1|STANDARD_ERROR_OF_MEAN|1.68||0.215|TWO_SIDED|95.0|-5.38|1.22||P value for test of difference between each elagolix dose group and placebo at each post-baseline time point is from ANCOVA model with treatment as the main effect and baseline as covariate.|ANCOVA|||Final Month||1.22|-5.38|0.215
72389016|NCT01817530|144286172|SUPERIORITY||difference in LS means|-1.4|STANDARD_ERROR_OF_MEAN|1.68||0.392|TWO_SIDED|95.0|-4.75|1.87||P value for test of difference between each elagolix dose group and placebo at each post-baseline time point is from ANCOVA model with treatment as the main effect and baseline as covariate.|ANCOVA|||Final Month||1.87|-4.75|0.392
72389017|NCT03281577|144286193|SUPERIORITY||Least Squares Mean Differences|-25.81||||0.0012|TWO_SIDED|95.0|-41.757|-9.858||Dunnett's test was used to compare each treatment arm to placebo. Multiplicity Adjusted p-value and 95% confidence interval (CI) are presented.|ANCOVA||Linear mixed effects model used for analyses using gastroparesis type \[diabetic or idiopathic\], age, gender, BMI, baseline as covariate.|||-9.858|-41.757|0.0012
72389018|NCT03281577|144286193|SUPERIORITY||Least Squares Mean Differences|-27.52||||0.0018|TWO_SIDED|95.0|-45.224|-9.813||Dunnett's test was used to compare each treatment arm to placebo. Multiplicity Adjusted p-value and 95% CI are presented.|ANCOVA||Linear mixed effects model used for analyses using gastroparesis type \[diabetic or idiopathic\], age, gender, BMI, baseline as a covariate.|||-9.813|-45.224|0.0018
72389019|NCT03281577|144286193|SUPERIORITY||Least Squares Mean Differences|-41.76|||<|0.0001|TWO_SIDED|95.0|-59.616|-23.902||Dunnett's test was used to compare each treatment arm to placebo. Multiplicity Adjusted p-value and 95% CI are presented.|ANCOVA||Linear mixed effects model used for analyses using gastroparesis type \[diabetic or idiopathic\], age, gender, BMI, baseline as a covariate.|||-23.902|-59.616|<.0001
72389020|NCT03281577|144286194|SUPERIORITY||Least Squares Mean Differences|0.72||||0.259|TWO_SIDED|95.0|-0.364|1.795||Dunnett's test was used to compare each treatment arm to placebo. Multiplicity Adjusted p-value and 95% CI are presented.|ANCOVA||Linear mixed effects model used for analyses using gastroparesis type \[diabetic or idiopathic\], age, gender, BMI, baseline as a covariate.|Colonic Transit at 4 Hours, Day 2||1.795|-0.364|0.2590
72389021|NCT03281577|144286194|SUPERIORITY||Least Squares Mean Differences|1.27||||0.028|TWO_SIDED|95.0|0.119|2.418||Dunnett's test was used to compare each treatment arm to placebo. Multiplicity Adjusted p-value and 95% CI are presented.|ANCOVA||Linear mixed effects model used for analyses using gastroparesis type \[diabetic or idiopathic\], age, gender, BMI, baseline as a covariate.|Colonic Transit at 4 Hours, Day 2||2.418|0.119|0.0280
72389022|NCT03281577|144286194|SUPERIORITY||Least Squares Mean Differences|0.45||||0.6882|TWO_SIDED|95.0|-0.757|1.66||Dunnett's test was used to compare each treatment arm to placebo. Multiplicity Adjusted p-value and 95% CI are presented.|ANCOVA||Linear mixed effects model used for analyses using gastroparesis type \[diabetic or idiopathic\], age, gender, BMI, baseline as a covariate.|Colonic Transit at 4 Hours, Day 2||1.660|-0.757|0.6882
72389023|NCT03281577|144286194|SUPERIORITY||Least Squares Mean Differences|1.87||||0.0062|TWO_SIDED|95.0|0.493|3.25||Dunnett's test was used to compare each treatment arm to placebo. Multiplicity Adjusted p-value and 95% CI are presented.|ANCOVA||Linear mixed effects model used for analyses using gastroparesis type \[diabetic or idiopathic\], age, gender, BMI, baseline as a covariate.|Colonic Transit at 24 Hours, Day 2||3.250|0.493|0.0062
72389024|NCT03281577|144286194|SUPERIORITY||Least Squares Mean Differences|1.19||||0.149|TWO_SIDED|95.0|-0.327|2.717||Dunnett's test was used to compare each treatment arm to placebo. Multiplicity Adjusted p-value and 95% CI are presented.|ANCOVA||Linear mixed effects model used for analyses using gastroparesis type \[diabetic or idiopathic\], age, gender, BMI, baseline as a covariate.|Colonic Transit at 24 Hours, Day 2||2.717|-0.327|0.1490
72389025|NCT03281577|144286194|SUPERIORITY||Least Squares Mean Differences|0.63||||0.6285|TWO_SIDED|95.0|-0.931|2.2||Dunnett's test was used to compare each treatment arm to placebo. Multiplicity Adjusted p-value and 95% CI are presented.|ANCOVA||Linear mixed effects model used for analyses using gastroparesis type \[diabetic or idiopathic\], age, gender, BMI, baseline as a covariate.|Colonic Transit at 24 Hours, Day 2||2.200|-0.931|0.6285
72389026|NCT03281577|144286194|SUPERIORITY||Least Squares Mean Differences|1.29||||0.0358|TWO_SIDED|95.0|0.073|2.501||Dunnett's test was used to compare each treatment arm to placebo. Multiplicity Adjusted p-value and 95% CI are presented.|ANCOVA||Linear mixed effects model used for analyses using gastroparesis type \[diabetic or idiopathic\], age, gender, BMI, baseline as a covariate.|Colonic Transit at 48 Hours, Day 2||2.501|0.073|0.0358
72444110|NCT03052608|144402196|SUPERIORITY||Mean Difference (Net)|3.36||||0.1143|TWO_SIDED|95.0|-0.82|7.55|||Mixed Models Analysis|||This is the analysis for QLQ-LC13 Pain in Other Parts. Estimated change from baseline was based on random intercept random slope mixed-effects model with an intercept term, treatment, time (as a continuous variable), treatment-by-time, baseline and randomization stratification factors as covariates.||7.55|-0.82|0.1143
72444111|NCT03052608|144402199|SUPERIORITY||Hazard Ratio (HR)|1.09||||0.7293|TWO_SIDED|95.0|0.822|1.444|||one-sided stratified log-rank|Stratified by the presence of brain metastases (Yes/No) and ethnic origin (Asian/Non-Asian) at randomization.|Based on Cox Proportional Hazards model stratified by the presence of brain metastases and ethnic origin at randomization. Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of Lorlatinib.|||1.444|0.822|0.7293
72444112|NCT04204278|144402212|OTHER||||||<|0.0001||||||P-Value was calculated|t-test, 1 sided|||||||<0.0001
72444113|NCT04204278|144402213|OTHER||||||<|0.0001|||||||t-test, 1 sided|P-Value was calculated||||||<0.0001
72444114|NCT04204278|144402214|OTHER||||||<|0.0001||||||P-Value was calculated|t-test, 1 sided|||||||<0.0001
72444115|NCT05249439|144402217|OTHER|Paired t-test|Mean Difference (Final Values)|-12.99|||<|0.0001|TWO_SIDED||||||t-test, 2 sided|||I-SatPro starting weight Vs 52 week weight (kg)||||<0.0001
72444116|NCT05873751|144402279|OTHER||Calibrated VE|2.74|||||TWO_SIDED|95.0|-10.35|15.59|||||VE = 1 - HR\*100. The HRs were estimated by exponentiating the coefficient for the vaccine variable in the model. VE was adjusted for the covariates age, gender, and US census region.|||15.59|-10.35|
72444117|NCT05873751|144402280|OTHER||Calibrated VE|-2.2|||||TWO_SIDED|95.0|-23.5|13.85|||||VE = 1 - HR\*100. The HRs were estimated by exponentiating the coefficient for the vaccine variable in the model. VE was adjusted for the covariates age, gender, and US census region.|||13.85|-23.50|
72560226|NCT01559116|144651145|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.102|STANDARD_ERROR_OF_MEAN|0.015|<|0.0001|TWO_SIDED|95.0|0.072|0.132|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Tiotropium high dose (5 µg) is calculated.|||0.132|0.072|<0.0001
72444118|NCT05873751|144402281|OTHER||Calibrated VE|2.74|||||TWO_SIDED|95.0|-10.35|15.59|||||VE = 1 - HR\*100. The HRs were estimated by exponentiating the coefficient for the vaccine variable in the model. VE was adjusted for the covariates age, gender, and US census region.|||15.59|-10.35|
72444119|NCT05873751|144402282|OTHER||Calibrated VE|-2.2|||||TWO_SIDED|95.0|-23.5|13.85|||||VE = 1 - HR\*100. The HRs were estimated by exponentiating the coefficient for the vaccine variable in the model. VE was adjusted for the covariates age, gender, and US census region.|||13.85|-23.50|
72444120|NCT00274469|144402292|NON_INFERIORITY|Study is powered basing on 20% deficiency in benefit rate for Fulvestrant compared to Anastrozole.|Odds Ratio (OR)|1.302||||0.386|TWO_SIDED|95.0|0.717|2.38||Null hypothesis: Fulvestrant has no difference with Anastrozole|Regression, Logistic||OR\>1 favours Fulvestrant|||2.380|0.717|0.386
72444121|NCT00274469|144402293|SUPERIORITY||Odds Ratio (OR)|1.021||||0.947|TWO_SIDED|95.0|0.556|1.874|||Regression, Logistic||OR\>1 favours Fulvestrant|||1.874|0.556|0.947
72444122|NCT00274469|144402294|SUPERIORITY||Hazard Ratio (HR)|0.6266||||0.0496|TWO_SIDED|95.0|0.3929|0.9991|||Log Rank||HR\<1 favours Fulvestrant|||0.9991|0.3929|0.0496
72444123|NCT00274469|144402295|SUPERIORITY||Hazard Ratio (HR)|0.73||||0.05|TWO_SIDED|95.0|0.54|1.0|||Log Rank||HR\<1 favours Fulvestrant|||1.00|0.54|0.05
72444124|NCT00274469|144402295|SUPERIORITY||Hazard Ratio (HR)|0.72||||0.04|TWO_SIDED|95.0|0.52|0.98|||Regression, Cox|Cox regression analysis of TTTF controlling for baseline covariates.|HR\<1 favours Fulvestrant|||0.98|0.52|0.04
72444125|NCT00274469|144402296|SUPERIORITY||Hazard Ratio (HR)|0.66||||0.01|TWO_SIDED|95.0|0.47|0.92|||Log Rank||HR\<1 favours Fulvestrant|||0.92|0.47|0.01
72444126|NCT00274469|144402296|SUPERIORITY||Hazard Ratio (HR)|0.64||||0.01|TWO_SIDED|95.0|0.46|0.9|||Regression, Cox|Cox regression analysis of TTP (investigator assessed) controlling for baseline covariates.|HR\<1 favours Fulvestrant|||0.90|0.46|0.01
72444127|NCT00274469|144402297|SUPERIORITY||Hazard Ratio (HR)|0.7||||0.041|TWO_SIDED|95.0|0.5|0.98|||Log Rank|||||0.98|0.50|0.041
72444128|NCT00274469|144402297|SUPERIORITY||Hazard Ratio (HR)|0.76||||0.126|TWO_SIDED|95.0|0.54|1.08|||Regression, Cox|Cox regression analysis of OS controlling for baseline covariates|HR\<1 favours Fulvestrant|||1.08|0.54|0.126
72444129|NCT06647238|144402300|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
72444130|NCT00593489|144402323|SUPERIORITY||Risk Ratio (RR)|0.99||||0.96|TWO_SIDED|95.0|0.8|1.24|||Poisson Regression|||The IPR was analyzed using Poisson regression with the intervention group as a class effect and the mean HbA1c at baseline as a covariate||1.24|0.8|0.96
72444131|NCT05386355|144402434|SUPERIORITY||Risk Ratio (RR)|1.79|||||TWO_SIDED|95.0|0.59|5.35|||||The General Health App is the reference group.|A mixed-effect Poisson regression with robust variance estimation was used report the adjusted RR with 95% CI accounting for the clinic-specific random intercepts. Given the small number of COVID-19 vaccination completion, we were unable to account for children nested with parent/caregiver or adjusting for covariates.||5.35|0.59|
72444132|NCT05386355|144402435|SUPERIORITY||Risk Ratio (RR)|0.84|||||TWO_SIDED|95.0|0.42|1.65|||||The General Health App is the reference group.|A mixed-effect Poisson regression with robust variance estimation was used report the adjusted RR with 95% CI accounting for the clinic-specific random intercepts. Given the small number of COVID-19 vaccination completion, we were unable to account for children nested with parent/caregiver or adjusting for covariates.||1.65|0.42|
72444133|NCT05386355|144402436|SUPERIORITY||Mean Difference (Final Values)|-0.23||||0.638|TWO_SIDED|95.0|-1.19|0.73|||Mixed Models Analysis|The analytical method was based on a linear mixed model adjusting for baseline SAGE vaccine hesitancy composite scores and random clinic effect.||||0.73|-1.19|0.638
72444134|NCT06143670|144402437|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 12 (Test for non-zero within group change from Baseline)||||<0.0001
72444135|NCT06143670|144402438|SUPERIORITY||Adjusted Mean Difference|-16.9|STANDARD_ERROR_OF_MEAN|1.4|<|0.0001|TWO_SIDED|95.0|-19.6|-14.1|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as test product minus reference product.|Change from Baseline at Week 12||-14.1|-19.6|<0.0001
72444136|NCT06143670|144402439|SUPERIORITY||Adjusted Mean Difference|-16.0|STANDARD_ERROR_OF_MEAN|1.46|<|0.0001|TWO_SIDED|95.0|-18.9|-13.1|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as test product minus reference product.|Change from Baseline at Week 3||-13.1|-18.9|<0.0001
72444137|NCT06143670|144402439|SUPERIORITY||Adjusted Mean Difference|-17.6|STANDARD_ERROR_OF_MEAN|1.17|<|0.0001|TWO_SIDED|95.0|-19.9|-15.3|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as test product minus reference product.|Change from Baseline at Week 6||-15.3|-19.9|<0.0001
72444138|NCT06143670|144402440|SUPERIORITY||Adjusted Mean Difference|-0.28|STANDARD_ERROR_OF_MEAN|0.036|<|0.0001|TWO_SIDED|95.0|-0.35|-0.2|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as test product minus reference product.|Change from Baseline at Week 3||-0.20|-0.35|<0.0001
72444139|NCT06143670|144402440|SUPERIORITY||Adjusted Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.032|<|0.0001|TWO_SIDED|95.0|-0.26|-0.13|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as test product minus reference product.|Change from Baseline at Week 6||-0.13|-0.26|<0.0001
72444140|NCT06143670|144402440|SUPERIORITY||Adjusted Mean Difference|-0.29|STANDARD_ERROR_OF_MEAN|0.035|<|0.0001|TWO_SIDED|95.0|-0.36|-0.22|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as test product minus reference product.|Change from Baseline at Week 12||-0.22|-0.36|<0.0001
72444141|NCT06143670|144402441|SUPERIORITY||Adjusted Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.03|<|0.0001|TWO_SIDED|95.0|-0.28|-0.16|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as test product minus reference product.|Change from Baseline at Week 3||-0.16|-0.28|<0.0001
72444142|NCT06143670|144402441|SUPERIORITY||Adjusted Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.028|<|0.0001|TWO_SIDED|95.0|-0.21|-0.1|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as test product minus reference product.|Change from Baseline at Week 6||-0.10|-0.21|<0.0001
72444143|NCT06143670|144402441|SUPERIORITY||Adjusted Mean Difference|-0.24|STANDARD_ERROR_OF_MEAN|0.03|<|0.0001|TWO_SIDED|95.0|-0.3|-0.18|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as test product minus reference product.|Change from Baseline at Week 12||-0.18|-0.30|<0.0001
72444144|NCT06143670|144402442|SUPERIORITY||Adjusted Mean Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|-0.15|-0.1|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as test product minus reference product.|Change from Baseline at Week 3||-0.10|-0.15|<0.0001
72444145|NCT06143670|144402442|SUPERIORITY||Adjusted Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.01|<|0.0001|TWO_SIDED|95.0|-0.17|-0.13|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as test product minus reference product.|Change from Baseline at Week 6||-0.13|-0.17|<0.0001
72444146|NCT06143670|144402442|SUPERIORITY||Adjusted Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|-0.16|-0.11|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as test product minus reference product.|Change from Baseline at Week 12||-0.11|-0.16|<0.0001
72444147|NCT06143670|144402443|SUPERIORITY||Adjusted Mean Difference|-0.64|STANDARD_ERROR_OF_MEAN|0.052|<|0.0001|TWO_SIDED|95.0|-0.74|-0.53|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as test product minus reference product.|Change from Baseline at Week 3||-0.53|-0.74|<0.0001
72444148|NCT06143670|144402443|SUPERIORITY||Adjusted Mean Difference|-0.65|STANDARD_ERROR_OF_MEAN|0.045|<|0.0001|TWO_SIDED|95.0|-0.74|-0.56|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as test product minus reference product.|Change from Baseline at Week 6||-0.56|-0.74|<0.0001
72444149|NCT06143670|144402443|SUPERIORITY||Adjusted Mean Difference|-0.67|STANDARD_ERROR_OF_MEAN|0.048|<|0.0001|TWO_SIDED|95.0|-0.77|-0.58|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as test product minus reference product.|Change from Baseline at Week 12||-0.58|-0.77|<0.0001
72497212|NCT03694392|144524272|OTHER||Hazard Ratio (HR)|0.98|||<|0.05|TWO_SIDED|95.0|0.88|1.08||Adjustment for multiplicity for the secondary outcomes was performed with the use of Holm's adjustment method.|Regression, Cox|Models were adjusted for age, age squared, sex, and race or ethnic group after weighting with stabilized facility-specific propensity scores.|Relative vaccine effectiveness (95% CI) calculated as 1 minus the hazard ratio, expressed as a percentage: 2.4% (-8.1% to 11.9%)|||1.08|0.88|<0.05
72444150|NCT04995484|144402459|OTHER||Geometric Mean Ratio|1.52|||||TWO_SIDED|90.0|0.95|2.43|||||Moderate Hepatic Impairment/Healthy|||2.43|0.95|
72444151|NCT04995484|144402460|OTHER||Geometric Mean Ratio|1.09|||||TWO_SIDED|90.0|0.84|1.42|||||Moderate Hepatic Impairment/Healthy|||1.42|0.84|
72444152|NCT04995484|144402461|OTHER||Geometric Mean Ratio|0.98|||||TWO_SIDED|90.0|0.76|1.26|||||Moderate Hepatic Impairment/Healthy|||1.26|0.76|
72444153|NCT00837369|144402466|SUPERIORITY||||||<|0.001|TWO_SIDED|95.0||||Compare the differences in sensitivity between myocardial perfusion and wall motion for detecting stenosis.|Chi-squared|||||||<0.001
72444154|NCT00837369|144402466|SUPERIORITY||||||<|0.001||||||Compare the sensitivity of myocardial perfusion in detecting stenosis within the first 4 minutes after regadenoson bolus injection to that of wall motion|Chi-squared|||||||<0.001
72444155|NCT05161715|144402490|OTHER|||||||0.425||||||No multiple testing correction was performed|Wilcoxon (Mann-Whitney)|||||||0.425
72444156|NCT05161715|144402491|OTHER|||||||0.0002||||||No multiple testing correction was performed|Wilcoxon (Mann-Whitney)|||||||0.0002
72444157|NCT05161715|144402492|OTHER|||||||0.0424||||||No multiple testing correction was performed|Wilcoxon (Mann-Whitney)|||||||0.0424
72444158|NCT05161715|144402493|OTHER|||||||0.001||||||No multiple testing correction was performed|Wilcoxon (Mann-Whitney)|||||||0.001
72444159|NCT05161715|144402498|OTHER|||||||0.556||||||No multiple testing correction was performed|Wilcoxon (Mann-Whitney)|||||||0.556
72444160|NCT03775109|144402499|SUPERIORITY||Mean Difference (Net)|16.7||||0.248|TWO_SIDED|95.0|-11.2|44.5||The threshold for statistical significance was p = 0.05|Chi-squared||Difference = Canakinumab - Placebo|It is estimated that improvement of histological alcoholic steatohepatitis will occur in 40% of patients treated with placebo and 80% of patients treated with Canakinumab. A trial with 80% power to detect a difference at the P \< 0.05 threshold would require 23 patients in each arm, 46 in total. Assuming a drop-out rate of 10%, we will recruit 52 patients in total (26 patients per group).||44.5|-11.2|0.248
72444161|NCT03775109|144402500|SUPERIORITY||Mean Difference (Net)|0.043|||||TWO_SIDED|95.0|-0.235|0.322|||||Difference = Canakinumab - Placebo|||0.322|-0.235|
72444162|NCT03775109|144402501|SUPERIORITY||Odds Ratio (OR)|3.133|||||TWO_SIDED|95.0|0.121|81.004||||||||81.004|0.121|
72444163|NCT03775109|144402502|SUPERIORITY||Odds Ratio (OR)|1.887|||||TWO_SIDED|95.0|0.357|9.965||||||||9.965|0.357|
72497213|NCT03694392|144524273|OTHER||Hazard Ratio (HR)|1.16|||<|0.05|TWO_SIDED|95.0|0.75|1.8|||Regression, Cox||Relative vaccine effectiveness (95% CI) calculated as 1 minus the hazard ratio, expressed as a percentage: -15.7% (-79.5% to 25.5%)|||1.80|0.75|<0.05
72497214|NCT03694392|144524274|OTHER||Hazard Ratio (HR)|1.001|||<|0.05|TWO_SIDED|95.0|0.95|1.06|||Regression, Cox||Relative vaccine effectiveness (95% CI) calculated as 1 minus the hazard ratio, expressed as a percentage: -0.1% (-6.0% to 5.4%)|||1.06|0.95|<0.05
72497215|NCT03694392|144524275|OTHER||Hazard Ratio (HR)|1.8|||<|0.05|TWO_SIDED|95.0|-2.2|5.5|||Regression, Cox||Relative vaccine effectiveness (95% CI) calculated as 1 minus the hazard ratio, expressed as a percentage: 1.8% (-2.2% to 5.5%)|||5.5|-2.2|<0.05
72497216|NCT03694392|144524276|OTHER||Hazard Ratio (HR)|9.4|||<|0.05|TWO_SIDED|95.0|-5.4|22.1|||Regression, Cox||Relative vaccine effectiveness (95% CI) calculated as 1 minus the hazard ratio, expressed as a percentage: 9.4% (-5.4% to 22.1%)|||22.1|-5.4|<0.05
72497217|NCT03694392|144524277|OTHER||Hazard Ratio (HR)|0.94|||<|0.05|TWO_SIDED|95.0|0.86|1.02|||Regression, Cox||Relative vaccine effectiveness (95% CI) calculated as 1 minus the hazard ratio, expressed as a percentage: 6.2% (-2.2% to 13.9%)|||1.02|0.86|<0.05
72497218|NCT03694392|144524278|OTHER||Hazard Ratio (HR)|1.07|||<|0.05|TWO_SIDED|95.0|0.75|1.52|||Regression, Cox||Relative vaccine effectiveness (95% CI) calculated as 1 minus the hazard ratio, expressed as a percentage: -6.9% (-51.6% to 24.6%)|||1.52|0.75|<0.05
72497219|NCT03694392|144524279|OTHER||Hazard Ratio (HR)|0.95|||<|0.05|TWO_SIDED|95.0|0.76|1.12|||Regression, Cox||Relative vaccine effectiveness (95% CI) calculated as 1 minus the hazard ratio, expressed as a percentage: 5.2% (-18.8% to 24.4%)|||1.12|0.76|<0.05
72497220|NCT03694392|144524280|OTHER||Hazard Ratio (HR)|0.89|||<|0.05|TWO_SIDED|95.0|0.85|0.93|||Regression, Cox||Relative vaccine effectiveness (95% CI) calculated as 1 minus the hazard ratio, expressed as a percentage: 10.8% (6.6% to 14.7%)|||0.93|0.85|<0.05
72497221|NCT03694392|144524281|OTHER||Hazard Ratio (HR)|1.001|||<|0.05|TWO_SIDED|95.0|0.94|1.06|||Regression, Cox||Relative vaccine effectiveness (95% CI) calculated as 1 minus the hazard ratio, expressed as a percentage: -0.1% (-6.2% to 5.6%)|||1.06|0.94|<0.05
72560227|NCT01559116|144651145|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.232|STANDARD_ERROR_OF_MEAN|0.015|<|0.0001|TWO_SIDED|95.0|0.201|0.262|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Placebo is calculated.|||0.262|0.201|<0.0001
72560228|NCT01559116|144651145|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.093|STANDARD_ERROR_OF_MEAN|0.015|<|0.0001|TWO_SIDED|95.0|0.063|0.123|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Olodaterol (5 µg) is calculated.|||0.123|0.063|<0.0001
72560229|NCT01559116|144651145|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.11|STANDARD_ERROR_OF_MEAN|0.015|<|0.0001|TWO_SIDED|95.0|0.08|0.14|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Tiotropium low dose (2.5 µg) is calculated.|||0.140|0.080|<0.0001
72560230|NCT01559116|144651145|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.091|STANDARD_ERROR_OF_MEAN|0.015|<|0.0001|TWO_SIDED|95.0|0.061|0.121|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Tiotropium high dose (5 µg) is calculated.|||0.121|0.061|<0.0001
72619170|NCT03016403|144769038|SUPERIORITY||Mean Difference (Final Values)|2.56||||0.0044|TWO_SIDED|95.0|0.8|4.32||Since there are three primary outcomes (depression, anxiety and coping scores) in the study, the significance level was set a priori at 0.0167 (alpha = 0.05/3).|Mixed Models Analysis|The pvalue corresponds to the hypothesis of the interaction effect between time and group (intervention arm).|The estimate represents the difference in expected means at the 6-month time point between the intervention and usual care arms.|A linear mixed model (LMM) with random intercepts for both patients and clinics has been used, with adjustment for cancer type and cancer stage. The study was powered for testing the hypothesis of no group differences in change over the four time points (baseline, 6-weeks, 3-months and 6-months). A significant group by time interaction was hypothesized.||4.32|0.8|0.0044
72560231|NCT01559116|144651146|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.207|STANDARD_ERROR_OF_MEAN|0.017|<|0.0001|TWO_SIDED|95.0|0.173|0.241|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Placebo is calculated.|||0.241|0.173|<0.0001
72560232|NCT01559116|144651146|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.092|STANDARD_ERROR_OF_MEAN|0.017|<|0.0001|TWO_SIDED|95.0|0.059|0.126|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Olodaterol (5 µg) is calculated.|||0.126|0.059|<0.0001
72497222|NCT03694392|144524282|OTHER||Hazard Ratio (HR)|1.46|||<|0.05|TWO_SIDED|95.0|1.06|2.0|||Regression, Cox||Relative vaccine effectiveness (95% CI) calculated as 1 minus the hazard ratio, expressed as a percentage: -45.5% (-100.2% to -5.8%)|||2.00|1.06|<0.05
72497223|NCT03694392|144524283|OTHER||Hazard Ratio (HR)|0.9|||<|0.05|TWO_SIDED|95.0|0.82|0.99|||Regression, Cox||Relative vaccine effectiveness (95% CI) calculated as 1 minus the hazard ratio, expressed as a percentage: 10.2% (1.4% to 18.2%)|||0.99|0.82|<0.05
72497224|NCT03694392|144524284|OTHER||Hazard Ratio (HR)|1.16|||<|0.05|TWO_SIDED|95.0|0.95|1.43|||Regression, Cox||Relative vaccine effectiveness (95% CI) calculated as 1 minus the hazard ratio, expressed as a percentage: -16.2% (-43.0% to 5.5%)|||1.43|0.95|<0.05
72497225|NCT03694392|144524285|OTHER||Hazard Ratio (HR)|0.84|||<|0.05|TWO_SIDED|95.0|0.76|0.94|||Regression, Cox||Relative vaccine effectiveness (95% CI) calculated as 1 minus the hazard ratio, expressed as a percentage: 15.7% (6.0% to 24.5%)|||0.94|0.76|<0.05
72497226|NCT03694392|144524286|OTHER||Hazard Ratio (HR)|0.9|||<|0.05|TWO_SIDED|95.0|0.6|1.34|||Regression, Cox||Relative vaccine effectiveness (95% CI) calculated as 1 minus the hazard ratio, expressed as a percentage: 10.3% (-33.9% to 39.9%)|||1.34|0.60|<0.05
72497227|NCT05900115|144524294|EQUIVALENCE|To examine intervention effects on primary outcomes at posttest, we used linear regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect.|Slope|0.01|STANDARD_ERROR_OF_MEAN|0.04||0.77|TWO_SIDED||||||Regression, Linear|||||||0.77
72444164|NCT03775109|144402505|SUPERIORITY|||||||0.27|||||||ANCOVA|Change in log-transformed serum bilirubin from baseline to day 28. 49 participants were included in this analysis.||||||0.270
72444165|NCT03775109|144402506|SUPERIORITY|||||||0.0349|||||||ANCOVA|ANCOVA model: MELD score at Day 28 = intercept + treatment group indicator + baseline MELD score. 49 patients have data at Day 28 and baseline.||||||0.03490
72444166|NCT03775109|144402507|SUPERIORITY||Odds Ratio (OR)|5.088|||||TWO_SIDED|95.0|1.558|16.624|||||Ordinal logistic regression (proportional odds) model. GAHS at day 28 = intercept + treatment group indicator + baseline GAHS measurement. 48 participants have GAHS data at baseline and day 28.|||16.624|1.558|
72444167|NCT03775109|144402508|SUPERIORITY|||||||0.343|||||||ANCOVA|ANCOVA model: mDF score at day 28 = intercept + treatment group indicator + baseline mDF score.||Natural log transformation used for both baseline and day 28 measurements. 49 participants have mDF measurements at baseline and day 28.||||0.343
72444168|NCT03775109|144402509|SUPERIORITY||Mean Difference (Net)|0.083|||||TWO_SIDED|95.0|-0.529|0.696|||||difference = canakinumab - placebo. natural log transformation used.|||0.696|-0.529|
72444169|NCT03775109|144402510|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.000
72444170|NCT03775109|144402511|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.000
72444171|NCT03775109|144402512|SUPERIORITY||Cox Proportional Hazard|1.046|||||TWO_SIDED|95.0|0.147|7.424||||||||7.424|0.147|
72444172|NCT03775109|144402520|SUPERIORITY||Mean Difference (Net)|0.043|||||TWO_SIDED|95.0|-0.235|0.322|||||Difference = Canakinumab - Placebo|||0.322|-0.235|
72560233|NCT01559116|144651146|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.079|STANDARD_ERROR_OF_MEAN|0.017|<|0.0001|TWO_SIDED|95.0|0.045|0.113|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Tiotropium high dose (5 µg) is calculated.|||0.113|0.045|<0.0001
72619171|NCT05463705|144769039|EQUIVALENCE|We estimated that 178 providers caring for 1,249 eligible patients would provide 80% power to observe an 11 percentage-point difference in prescribing rates between each intervention arm and control, assuming a control arm prescribing rate of 30%, an ICC of 0.07 (estimated based on prior studies in this system), an average of 7 patients per provider, and a type I error rate of 5%.|Odds Ratio (OR)|1.31|||||TWO_SIDED|95.0|0.88|1.96||||||||1.96|0.88|
72444173|NCT03775109|144402521|SUPERIORITY||Mean Difference (Net)|-0.13|||||TWO_SIDED|95.0|-0.388|0.127|||||Difference = Canakinumab - Placebo|||0.127|-0.388|
72444174|NCT03775109|144402522|SUPERIORITY||Odds Ratio (OR)|4.012|||||TWO_SIDED|95.0|0.693|23.219||||||||23.219|0.693|
72444175|NCT03775109|144402523|SUPERIORITY||Odds Ratio (OR)|4.543|||||TWO_SIDED|95.0|0.543|38.043||||||||38.043|0.543|
72444176|NCT03775109|144402524|SUPERIORITY||Odds Ratio (OR)|1.745|||||TWO_SIDED|95.0|0.456|6.558||||||||6.558|0.456|
72444177|NCT03775109|144402525|SUPERIORITY||Odds Ratio (OR)|0.977|||||TWO_SIDED|95.0|0.281|3.397||||||||3.397|0.281|
72444178|NCT03775109|144402526|SUPERIORITY||Odds Ratio (OR)|0.768|||||TWO_SIDED|95.0|0.238|2.479||||||||2.479|0.238|
72444179|NCT05691452|144402540|SUPERIORITY||Mean Difference (Net)|20.05||||0.578|TWO_SIDED|95.0|-50.68|90.78||Generalized linear models generated estimated mean differences in the post-intervention values controlling for the baseline assessments.|Regression, Linear|||||90.78|-50.68|0.578
72560234|NCT01559116|144651146|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.201|STANDARD_ERROR_OF_MEAN|0.017|<|0.0001|TWO_SIDED|95.0|0.167|0.235|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Placebo is calculated.|||0.235|0.167|<0.0001
72619172|NCT05463705|144769039|EQUIVALENCE|We estimated that 178 providers caring for 1,249 eligible patients would provide 80% power to observe an 11 percentage-point difference in prescribing rates between each intervention arm and control, assuming a control arm prescribing rate of 30%, an ICC of 0.07 (estimated based on prior studies in this system),72,73 an average of 7 patients per provider, and a type I error rate of 5%.|Odds Ratio (OR)|1.0|||||TWO_SIDED|95.0|0.66|1.52||||||||1.52|0.66|
72619173|NCT05463705|144769040|SUPERIORITY|We estimated that 178 providers caring for 1,249 eligible patients would provide 80% power to observe an 11 percentage-point difference in prescribing rates between each intervention arm and control, assuming a control arm prescribing rate of 30%, an ICC of 0.07 (estimated based on prior studies in this system), an average of 7 patients per provider, and a type I error rate of 5%.|Odds Ratio (OR)|1.17|||||TWO_SIDED|95.0|0.83|1.61||||||||1.61|0.83|
72444180|NCT05691452|144402541|SUPERIORITY||Mean Difference (Net)|-21.2||||0.61|TWO_SIDED|95.0|-101.9|59.5|||Regression, Linear|||||59.5|-101.9|0.61
72444181|NCT05691452|144402542|SUPERIORITY||Mean Difference (Net)|1.55||||0.674|TWO_SIDED|95.0|-5.68|8.78|||Regression, Linear|||||8.78|-5.68|0.674
72444182|NCT05691452|144402543|SUPERIORITY||Mean Difference (Net)|-21.6||||0.013|TWO_SIDED|95.0|-38.5|-4.59|||Regression, Linear|||||-4.59|-38.5|.013
72444183|NCT05691452|144402544|SUPERIORITY||Mean Difference (Net)|0.387||||0.29|TWO_SIDED|95.0|-0.335|1.109|||Regression, Linear|||||1.109|-0.335|0.29
72444184|NCT05691452|144402545|SUPERIORITY||Mean Difference (Net)|-0.203||||0.701|TWO_SIDED|95.0|-1.24|0.833|||Regression, Linear|||||0.833|-1.24|0.701
72444185|NCT05691452|144402546|SUPERIORITY||Mean Difference (Net)|-21.45||||0.376|TWO_SIDED|95.0|-68.99|26.08|||Regression, Linear|||||26.08|-68.99|0.376
72444186|NCT00739648|144402569|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.09||||0.7282|TWO_SIDED|90.0|0.86|1.39|||Regression, Linear|negative binomial regression model||||1.39|0.86|0.7282
72444187|NCT00739648|144402571|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-15.2||||0.9768|TWO_SIDED|90.0|-27.8|-2.66|||Mixed Models Analysis|||||-2.66|-27.8|0.9768
72444188|NCT00739648|144402572|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-12.3||||0.9464|TWO_SIDED|90.0|-24.9|0.26|||Mixed Models Analysis|||||0.26|-24.9|0.9464
72444189|NCT04173663|144402573|SUPERIORITY||Slope|-3.27||||0.092|TWO_SIDED||||||Regression, Linear|Linear regression controlled for study site, cohort, and baseline value of the parental empowerment scale.||||||.092
72444190|NCT04173663|144402574|SUPERIORITY||Slope|-1.62||||1.54e-05|TWO_SIDED||||||Regression, Linear|Linear regression controlled for study site, cohort, and baseline value of the measure.||||||.0000154
72444191|NCT04173663|144402575|SUPERIORITY||Slope|-0.19||||0.014|TWO_SIDED||||||Regression, Linear|Linear regression controlled for study site, cohort, and baseline value of the measure.||||||.014
72444192|NCT04173663|144402576|SUPERIORITY||Slope|-0.13||||0.883|TWO_SIDED||||||Regression, Linear|Linear regression controlled for study site, cohort, and baseline value of the measure.||||||0.883
72444193|NCT04173663|144402577|SUPERIORITY||Slope|-0.11||||0.308|TWO_SIDED||||||Regression, Linear|Linear regression controlled for study site, cohort, and baseline value of the measure.||Outcome Variable: Number of services family applied for (6 month post intervention)||||.308
72444194|NCT04173663|144402577|SUPERIORITY||Slope|-0.11||||0.355|TWO_SIDED||||||Regression, Linear|Linear regression controlled for study site, cohort, and baseline value of the measure.||Outcome Variable: Number of services family applied for (12 month post intervention)||||.355
72444195|NCT04173663|144402578|SUPERIORITY||Slope|-0.06||||0.699|TWO_SIDED||||||Regression, Linear|Linear regression controlled for study site, cohort, and baseline value of the measure.||Outcome Variable: Number of government services family is receiving (6 month post intervention)||||.699
72444196|NCT04173663|144402578|SUPERIORITY||Slope|-0.1||||0.573|TWO_SIDED||||||Regression, Linear|Linear regression controlled for study site, cohort, and baseline value of the measure.||Outcome Variable: Number of government services the family is receiving (12 month post intervention)||||.573
72444197|NCT04173663|144402578|SUPERIORITY||Slope|-0.23||||0.43|TWO_SIDED||||||Regression, Linear|Linear regression controlled for study site, cohort, and baseline value of the measure.||Outcome Variable: Number of direct services the family is receiving (6 month post intervention)||||.430
72444198|NCT04173663|144402578|SUPERIORITY||Slope|0.27||||0.391|TWO_SIDED||||||Regression, Linear|Linear regression controlled for study site, cohort, and baseline value of the measure.||Outcome Variable: Number of direct services the family is receiving (12 month post intervention)||||.391
72444199|NCT04173663|144402579|SUPERIORITY||Slope|-0.44||||0.51|TWO_SIDED||||||Regression, Logistic|Logistic regression controlled for study site, cohort, and baseline value of the measure.||Outcome Variable: Whether participants were engaged or not engaged in vocational/educational activities (6 month post intervention)||||.510
72444200|NCT04173663|144402579|SUPERIORITY||Slope|0.64||||0.296|TWO_SIDED||||||Regression, Logistic|Logistic regression controlled for study site, cohort, and baseline value of the measure.||Outcome Variable: Whether participants were engaged or not engaged in vocational/educational activities (12 month post intervention)||||.296
72444201|NCT04173663|144402580|SUPERIORITY||Slope|-0.66||||0.361|TWO_SIDED||||||Regression, Linear|Linear regression controlled for study site, cohort, and baseline value of the measure.||||||.361
72444202|NCT04173663|144402581|SUPERIORITY||Slope|-0.08||||0.81|TWO_SIDED||||||Regression, Linear|Linear regression controlled for study site, cohort, and baseline value of the measure.||Outcome Variable: Number of unmet service needs (6 month post intervention)||||.810
72560235|NCT01559116|144651146|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.086|STANDARD_ERROR_OF_MEAN|0.017|<|0.0001|TWO_SIDED|95.0|0.052|0.12|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Olodaterol (5 µg) is calculated.|||0.120|0.052|<0.0001
72444203|NCT04173663|144402581|SUPERIORITY||Slope|-0.13||||0.678|TWO_SIDED||||||Regression, Linear|Linear regression controlled for study site, cohort, and baseline value of the measure.||Outcome Variable: Number of unmet service needs (12 month post intervention)||||.678
72444204|NCT04173663|144402582|SUPERIORITY||Slope|0.03||||0.924|TWO_SIDED||||||Regression, Linear|Linear regression controlled for study site and cohort,||||||.924
72444205|NCT02278562|144402585|SUPERIORITY|||||||0.37||||||0.05 is the a priori threshold for statistical significance|Wilcoxon Rank-Sum|||Prior data indicate that LDR is normally distributed with standard deviation ranging from 0.16 to 0.23 in hemodialysis and control patients, respectively. If the true difference in the experimental and control means is 0.21, we will be able to reject the null hypothesis that the population means of the experimental and control groups are equal with probability (power) 0.933. The Type I error probability associated with this test of this null hypothesis is 0.05.||||0.37
72560236|NCT01559116|144651146|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.101|STANDARD_ERROR_OF_MEAN|0.017|<|0.0001|TWO_SIDED|95.0|0.067|0.135|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Tiotropium low dose (2.5 µg) is calculated.|||0.135|0.067|<0.0001
72389027|NCT03281577|144286194|SUPERIORITY||Least Squares Mean Differences|1.33||||0.043|TWO_SIDED|95.0|0.035|2.621||Dunnett's test was used to compare each treatment arm to placebo. Multiplicity Adjusted p-value and 95% CI are presented.|ANCOVA||Linear mixed effects model used for analyses using gastroparesis type \[diabetic or idiopathic\], age, gender, BMI, baseline as a covariate.|Colonic Transit at 48 Hours, Day 2||2.621|0.035|0.0430
72389028|NCT03281577|144286194|SUPERIORITY||Least Squares Mean Differences|0.25||||0.9419|TWO_SIDED|95.0|-1.107|1.611||Dunnett's test was used to compare each treatment arm to placebo. Multiplicity Adjusted p-value and 95% CI are presented.|ANCOVA||Linear mixed effects model used for analyses using gastroparesis type \[diabetic or idiopathic\], age, gender, BMI, baseline as a covariate.|Colonic Transit at 48 Hours, Day 2||1.611|-1.107|0.9419
72389029|NCT03281577|144286195|SUPERIORITY||Least Squares Mean Differences|33.12||||0.0436|TWO_SIDED|95.0|0.799|65.439||Dunnett's test was used to compare each treatment arm to placebo. Multiplicity Adjusted p-value and 95% CI are presented.|ANCOVA||Linear mixed effects model used for analyses using gastroparesis type \[diabetic or idiopathic\], age, gender, BMI, baseline as a covariate.|||65.439|0.799|0.0436
72389030|NCT03281577|144286195|SUPERIORITY||Least Squares Mean Differences|57.98||||0.0007|TWO_SIDED|95.0|23.555|92.396||Dunnett's test was used to compare each treatment arm to placebo. Multiplicity Adjusted p-value and 95% CI are presented.|ANCOVA||Linear mixed effects model used for analyses using gastroparesis type \[diabetic or idiopathic\], age, gender, BMI, baseline as a covariate.|||92.396|23.555|0.0007
72389031|NCT03281577|144286195|SUPERIORITY||Least Squares Mean Differences|44.44||||0.0134|TWO_SIDED|95.0|8.249|80.629||Dunnett's test was used to compare each treatment arm to placebo. Multiplicity Adjusted p-value and 95% CI are presented.|ANCOVA||Linear mixed effects model used for analyses using gastroparesis type \[diabetic or idiopathic\], age, gender, BMI, baseline as a covariate.|||80.629|8.249|0.0134
72444206|NCT02278562|144402585|SUPERIORITY|||||||0.955||||||0.05 is the a priori threshold for statistical significance|Wilcoxon Rank-Sum|||Prior data indicate that LDR is normally distributed with standard deviation ranging from 0.16 to 0.23 in hemodialysis and control patients, respectively. If the true difference in the experimental and control means is 0.21, we will be able to reject the null hypothesis that the population means of the experimental and control groups are equal with probability (power) 0.933.||||0.955
72497228|NCT05900115|144524295|EQUIVALENCE|To examine intervention effects on primary outcomes at posttest, we used linear regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect.|Slope|0.02|STANDARD_ERROR_OF_MEAN|0.06||0.78|TWO_SIDED||||||Regression, Linear|||||||0.78
72497229|NCT05900115|144524296|EQUIVALENCE|To examine intervention effects on primary outcomes at posttest, we used linear regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect.|Slope|0.13|STANDARD_ERROR_OF_MEAN|0.12||0.28|TWO_SIDED||||||Regression, Linear|||||||0.28
72497230|NCT05900115|144524297|EQUIVALENCE|To examine intervention effects on primary outcomes at posttest, we used linear regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect.|Slope|0.05|STANDARD_ERROR_OF_MEAN|0.13||0.68|TWO_SIDED||||||Regression, Linear|||||||0.68
72497231|NCT05900115|144524298|EQUIVALENCE|To examine intervention effects on primary outcomes at posttest, we used linear regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect.|Slope|0.32|STANDARD_ERROR_OF_MEAN|0.13||0.01|TWO_SIDED||||||Regression, Linear|||||||0.01
72497232|NCT05900115|144524299|EQUIVALENCE|To examine intervention effects on primary outcomes at posttest, we used linear regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect.|Slope|-0.19|STANDARD_ERROR_OF_MEAN|0.14||0.18|TWO_SIDED||||||Regression, Linear|||||||0.18
72444207|NCT03391466|144402591|SUPERIORITY|One-sided p-value based on log-rank test stratified by response to first-line therapy and second-line age-adjusted International Prognostic Index (IPI) as data collected on case report forms.|Hazard Ratio (HR)|0.398|||<|0.0001|TWO_SIDED|95.0|0.308|0.514||Stratified (randomization factors) log-rank p-value.|Log Rank|Stratified (randomization stratification factors) log-rank test.|Hazard ratio (95% confidence interval (CI)), stratified using randomization stratification factors.|||0.514|0.308|<0.0001
72444208|NCT03391466|144402592|SUPERIORITY|One-sided p-value based on CMH test, one-sided tailed test, stratified by response to first-line therapy and second-line age-adjusted IPI as data collected on case report forms.|Difference in ORR|33.1|||<|0.0001|TWO_SIDED|95.0|23.2|42.1||Stratified (randomization factor) CMH test p-value.|Cochran-Mantel-Haenszel|Stratified (randomization factor) CMH test.|Difference in ORR (95% CI)|||42.1|23.2|<0.0001
72444209|NCT03391466|144402593|SUPERIORITY|One-sided p-value based on log-rank test stratified by response to first-line therapy and second-line age-adjusted IPI as data collected on case report forms.|Hazard Ratio (HR)|0.726||||0.0168|TWO_SIDED|95.0|0.54|0.977||Stratified log-rank (randomization factor) p-value.|Log Rank|Stratified (randomization factor) log-rank test.|Hazard ratio (95% CI), stratified using randomization stratification factors.||The Rho family spending function with parameter (Rho = 6) was used to allocate alpha between the interim and primary OS analysis. Given that fewer than the anticipated 210 events were observed at the data cutoff date for the primary OS analysis (25 January 2023), the efficacy boundary for the primary OS analysis was recalculated using the Rho family spending function based on the actual observed event numbers (177 deaths) resulting in an efficacy boundary at 1-sided significance level of 0.0249.|0.977|0.540|0.0168
72444210|NCT03391466|144402594|SUPERIORITY|One-sided p-value based on log-rank test stratified by response to first-line therapy and second-line age-adjusted IPI as data collected on case report forms.|Hazard Ratio (HR)|0.736||||0.0695|TWO_SIDED|95.0|0.488|1.108||Stratified (randomization stratification factors) log-rank test.|Log Rank||Hazard ratio (95% CI), stratified using randomization stratification factors.|||1.108|0.488|0.0695
72444211|NCT03391466|144402595|SUPERIORITY||Hazard Ratio (HR)|0.376|||<|0.0001|TWO_SIDED|95.0|0.29|0.487||One-sided p-value based on log-rank test stratified by response to first-line therapy and second-line age-adjusted IPI as data collected on case report forms.|Log Rank|Stratified (randomization stratification factors) log-rank test.|Hazard ratio (95% CI), stratified using randomization stratification factors.|||0.487|0.290|<0.0001
72497233|NCT05900115|144524300|EQUIVALENCE|To examine intervention effects on primary outcomes at posttest, we used linear regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect.|Slope|0.03|STANDARD_ERROR_OF_MEAN|0.12||0.83|TWO_SIDED||||||Regression, Linear|||||||0.83
72497234|NCT05900115|144524301|EQUIVALENCE|To examine intervention effects on primary outcomes at posttest, we used linear regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect.|Slope|-0.08|STANDARD_ERROR_OF_MEAN|0.13||0.56|TWO_SIDED||||||Regression, Linear|||||||0.56
72497235|NCT05900115|144524302|EQUIVALENCE|To examine intervention effects on primary dichotomous outcomes at posttest, we used logistic regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect.|Odds Ratio (OR)|1.11|STANDARD_ERROR_OF_MEAN|0.54||0.85|TWO_SIDED|95.0|0.38|3.2|||Regression, Logistic|||||3.20|.38|0.85
72497236|NCT05900115|144524303|EQUIVALENCE|To examine intervention effects on primary outcomes at posttest, we used linear regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect.|Slope|0.0|STANDARD_ERROR_OF_MEAN|0.05||1|TWO_SIDED||||||Regression, Linear|||||||1.00
72497237|NCT00880750|144524317|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|A standard 90% confidence interval (CI) was constructed for the difference in least square means of the primary pharmacodynamic (PD) variable between the granules formulation and the reference chewable tablet formulation. A critical reference representing +/- 20% of the reference chewable tablet formulation least squares mean was constructed. PD equivalence was to be claimed if the 90% CI was completely contained within the critical reference range of (-3.47, 3.47).|Mean Difference (Final Values)|-1.35|||||TWO_SIDED|90.0|-2.18|-0.51|||Mixed Models Analysis|||||-0.51|-2.18|
72497238|NCT00880750|144524318|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|A standard 90% confidence interval (CI) was constructed for the difference in least square means of the primary pharmacodynamic (PD) variable between the granules formulation and the reference chewable tablet formulation. A critical reference representing +/- 20% of the reference chewable tablet formulation least squares mean was constructed. PD equivalence was to be claimed if the 90% CI was completely contained within the critical reference range of (-3.40, 3.40).|Mean Difference (Final Values)|-1.98|||||TWO_SIDED|90.0|-3.17|-0.8|||Mixed Models Analysis|||||-0.80|-3.17|
72444212|NCT03391466|144402596|SUPERIORITY||Hazard Ratio (HR)|0.422|||||TWO_SIDED|95.0|0.327|0.545|||||Hazard ratio (95% CI), stratified using randomization stratification factors.|||0.545|0.327|
72444213|NCT03391466|144402597|SUPERIORITY||Hazard Ratio (HR)|0.506|||||TWO_SIDED|95.0|0.383|0.669|||||Hazard ratio (95% CI), stratified using randomization stratification factors.|||0.669|0.383|
72444214|NCT03391466|144402599|SUPERIORITY||Mixed Model with Repeated Measures|18.1|||<|0.0001|TWO_SIDED|95.0|12.3|23.9||False Discovery Rate Methodology|Mixed Model with Repeated Measures|||Difference in mean change of scores from Baseline at Day 100.||23.9|12.3|<0.0001
72444215|NCT03391466|144402599|SUPERIORITY||Mixed Model with Repeated Measures|9.8||||0.0124|TWO_SIDED|95.0|2.6|17.0||False Discovery Rate Methodology|Mixed Model with Repeated Measures|||Difference in mean change of scores from Baseline at Day 150.||17.0|2.6|0.0124
72444216|NCT03391466|144402599|SUPERIORITY||Mixed Model with Repeated Measures|4.4||||0.2655|TWO_SIDED|95.0|-3.3|12.0||False Discovery Rate Methodology|Mixed Model with Repeated Measures|||Difference in mean change of scores from Baseline at Month 9.||12.0|-3.3|0.2655
72444217|NCT03391466|144402600|SUPERIORITY||Mixed Model with Repeated Measures|13.1|||<|0.0001|TWO_SIDED|95.0|8.0|18.2||False Discovery Rate Methodology.|Mixed Model with Repeated Measures|||Difference in mean change of scores from Baseline at Day 100.||18.2|8.0|<0.0001
72444218|NCT03391466|144402600|SUPERIORITY||Mixed Model with Repeated Measures|5.1||||0.1253|TWO_SIDED|95.0|-0.9|11.0||False Discovery Rate Methodology.|Mixed Model with Repeated Measures|||Difference in mean change of scores from Baseline at Day 150.||11.0|-0.9|0.1253
72444219|NCT03391466|144402601|SUPERIORITY||Mixed Model with Repeated Measures|0.081||||0.0112|TWO_SIDED|95.0|0.024|0.138||False Discovery Rate Methodology.|Mixed Model with Repeated Measures|||Difference in mean change of scores from Baseline at Day 100.||0.138|0.024|0.0112
72444220|NCT03391466|144402601|SUPERIORITY||Mixed Model with Repeated Measures|0.028||||0.3703|TWO_SIDED|95.0|-0.034|0.091||False Discovery Rate Methodology.|Mixed Model with Repeated Measures|||Difference in mean change of scores from Baseline at Day 150.||0.091|-0.034|0.3703
72444221|NCT03391466|144402602|SUPERIORITY||Mixed Model with Repeated Measures|13.7|||<|0.0001|TWO_SIDED|95.0|8.5|18.8||False Discovery Rate Methodology|Mixed Model with Repeated Measures|Mixed Model with Repeated Measures Differences in Change from Baseline.||Difference in mean change of scores from Baseline at Day 100.||18.8|8.5|<0.0001
72444222|NCT03391466|144402602|SUPERIORITY||Mixed Model with Repeated Measures|11.3||||0.0004|TWO_SIDED|95.0|5.4|17.1||False Discovery Rate Methodology|Mixed Model with Repeated Measures|||Difference in mean change of scores from Baseline at Day 150.||17.1|5.4|0.0004
72444223|NCT03391466|144402602|SUPERIORITY||Mixed Model with Repeated Measures|3.8||||0.2549|TWO_SIDED|95.0|-2.3|10.0||False Discovery Rate Methodology.|Mixed Model with Repeated Measures|Mixed Model with Repeated Measures Differences in Change from Baseline.||Difference in mean change of scores from Baseline at Month 9.||10.0|-2.3|0.2549
72444224|NCT03655132|144402609|OTHER|Regression of baseline score on intrinsic motivation to use VACT-CP online program on actual VACT-CP use (i.e., number of modules completed.)|Pearson's correlation coefficient|0.12||||0.62|TWO_SIDED||||||Regression, Linear|||||||.62
72444225|NCT03655132|144402609|OTHER|Regression of baseline score on perceived ease of use of the VACT-CP online program on actual VACT-CP use (i.e., number of modules completed.)|Pearson's correlation coefficient|0.19||||0.45|TWO_SIDED||||||Regression, Linear|||||||.45
72444226|NCT03655132|144402609|OTHER|Regression of baseline score on perceived usefulness of the VACT-CP online program on actual VACT-CP use (i.e., number of modules completed.)|Pearson's correlation coefficient|0.02||||0.93|TWO_SIDED||||||Regression, Linear|||||||.93
72444227|NCT03655132|144402609|OTHER|Regression of post-intervention score of intrinsic motivation to use VACT-CP online program on actual VACT-CP use (i.e., number of modules completed.)|Pearson's correlation coefficient|0.51||||0.04|TWO_SIDED||||||Regression, Linear|||||||.04
72444228|NCT03655132|144402609|OTHER|Regression of post-intervention score of perceived ease of use of the VACT-CP online program on actual VACT-CP use (i.e., number of modules completed.)|Pearson's correlation coefficient|0.54||||0.03|TWO_SIDED||||||Regression, Linear|||||||.03
72444229|NCT03655132|144402609|OTHER|Regression of post-intervention score of perceived usefulness of VACT-CP online program on actual VACT-CP use (i.e., number of modules completed.)|Pearson's correlation coefficient|0.58||||0.01|TWO_SIDED||||||Regression, Linear|||||||.01
72444230|NCT03655132|144402610|OTHER|Wilcoxon Signed Ranks Test comparing baseline score to post-score (approximately Week 8) for waitlist control group participants only (n=22).|Median Difference (Net)|-5.0||||0.54|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.54
72444231|NCT03655132|144402610|OTHER||Median Difference (Net)|-1.5||||0.59|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Signed Ranks Test comparing baseline score to post-score (approximately Week 8) for VACT-CP group.||||.59
72444232|NCT03655132|144402611|OTHER|Wilcoxon Signed Ranks Test comparing baseline score to post-score (approximately Week 8).|Median Difference (Net)|2.0||||0.78|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.78
72444233|NCT03655132|144402611|OTHER|Wilcoxon Signed Ranks Test comparing baseline score to post-score (approximately Week 8).|Median Difference (Net)|14.0|||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<.001
72444234|NCT03655132|144402612|OTHER|Wilcoxon Signed Ranks Test comparing baseline score to post-score (approximately Week 8).|Median Difference (Net)|0.5||||0.13|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.13
72444235|NCT03655132|144402612|OTHER|Wilcoxon Signed Ranks Test comparing baseline score to post-score (approximately Week 8).|Median Difference (Net)|3.0||||0.07|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.07
72444236|NCT03655132|144402613|OTHER|Wilcoxon Signed Ranks Test comparing baseline score to post-score (approximately Week 8).|Median Difference (Net)|0.0||||0.64|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.64
72444237|NCT03655132|144402613|OTHER|Wilcoxon Signed Ranks Test comparing baseline score to post-score (approximately Week 8).|Median Difference (Net)|-0.3||||0.3|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.30
72444238|NCT03655132|144402614|OTHER|Wilcoxon Signed Ranks Test comparing baseline score to post-score (approximately Week 8).|Median Difference (Net)|0.5||||0.75|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.75
72444239|NCT03655132|144402614|OTHER|Wilcoxon Signed Ranks Test comparing baseline score to post-score (approximately Week 8).|Median Difference (Net)|-0.5||||0.6|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.60
72497239|NCT00880750|144524319|SUPERIORITY_OR_OTHER_LEGACY||Ratio of geometric LS means|1.34||||||90.0|1.26|1.42|||Mixed Models Analysis|After application of the log transformation AUC 0-48 was analysed using a mixed effect linear model.||The LS means and associated SEs for granules and tablets as well as the difference between granules and tablets were determined. From the LS mean and SE of the difference, a 90% CI was constructed for the difference of the logs of granules and tablets. An exponential transformation was applied to the lower and upper limits of the CI. This created a point estimate and 90% CI for the ratio of LS means for granules to tablets.||1.42|1.26|
72560237|NCT01559116|144651146|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.073|STANDARD_ERROR_OF_MEAN|0.017|<|0.0001|TWO_SIDED|95.0|0.039|0.107|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Tiotropium high dose (5 µg) is calculated.|||0.107|0.039|<0.0001
72389032|NCT03281577|144286196|SUPERIORITY||Least Squares Mean Differences|-10.27||||0.0789|TWO_SIDED|95.0|-21.507|0.96||Dunnett's test was used to compare each treatment arm to placebo. Multiplicity Adjusted p-value and 95% CI are presented.|ANCOVA||Linear mixed effects model used for analyses using gastroparesis type \[diabetic or idiopathic\], age, gender, BMI, baseline as a covariate.|||0.960|-21.507|0.0789
72389033|NCT03281577|144286196|SUPERIORITY||Least Squares Mean Differences|-13.28||||0.027|TWO_SIDED|95.0|-25.242|-1.314||Dunnett's test was used to compare each treatment arm to placebo. Multiplicity Adjusted p-value and 95% CI are presented.|ANCOVA||Linear mixed effects model used for analyses using gastroparesis type \[diabetic or idiopathic\], age, gender, BMI, baseline as a covariate.|||-1.314|-25.242|0.0270
72389034|NCT03281577|144286196|SUPERIORITY||Least Squares Mean Differences|-11.63||||0.075|TWO_SIDED|95.0|-24.206|0.952||Dunnett's test was used to compare each treatment arm to placebo. Multiplicity Adjusted p-value and 95% CI are presented.|ANCOVA||Linear mixed effects model used for analyses using gastroparesis type \[diabetic or idiopathic\], age, gender, BMI, baseline as a covariate.|||0.952|-24.206|0.0750
72389035|NCT01663532|144286223|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.9||||0.0005|TWO_SIDED|95.0|-6.1|-1.7||Kenward-Rodger degree of freedom was used to test the treatment effects and p-value was not adjusted as this is a primary efficacy endpoint.|Mixed Models Analysis|MMRM analysis with treatment, pooled centers, Week and treatment-by-Week, and Baseline-by-Week interaction as an unstructured covariate was performed.|Difference in Least Square (LS) mean of change and 95% Confidence interval were derived from pair-wise comparison within MMRM at Week 1.|Null hypothesis of change from Baseline in PANSS total score of aripiprazole IM depot 400/300mg group is same as that of placebo group was tested. The sample size estimated a 1:1 randomization ratio (aripiprazole IM depot 400/300mg: placebo) to achieve 90% power and to preserve a nominal alpha level of 0.05 given a treatment difference of -7.5 points in change from Baseline with standard deviation of 20 points between aripiprazole and placebo using a two-sided z-test.||-1.7|-6.1|0.0005
72389036|NCT01663532|144286223|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.0|||<|0.0001|TWO_SIDED|95.0|-10.0|-4.0||Kenward-Rodger degree of freedom was used to test the treatment effects and p-value was not adjusted as this is a primary efficacy endpoint.|Mixed Models Analysis|MMRM analysis with treatment, pooled centers, Week and treatment-by-Week, and Baseline-by-Week interaction as an unstructured covariate was performed.|Difference in Least Square (LS) mean of change and 95% Confidence interval were derived from pair-wise comparison within MMRM at Week 2.|Null hypothesis of change from Baseline in PANSS total score of aripiprazole IM depot 400/300mg group is same as that of placebo group was tested. The sample size estimated a 1:1 randomization ratio (aripiprazole IM depot 400/300mg: placebo) to achieve 90% power and to preserve a nominal alpha level of 0.05 given a treatment difference of -7.5 points in change from Baseline with standard deviation of 20 points between aripiprazole and placebo using a two-sided z-test.||-4.0|-10.0|<.0001
72389037|NCT01663532|144286223|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.2|||<|0.0001|TWO_SIDED|95.0|-12.8|-5.6||Kenward-Rodger degree of freedom was used to test the treatment effects and p-value was not adjusted as this is a primary efficacy endpoint.|Mixed Models Analysis|MMRM analysis with treatment, pooled centers, Week and treatment-by-Week, and Baseline-by-Week interaction as an unstructured covariate was performed.|Difference in Least Square (LS) mean of change and 95% Confidence interval were derived from pair-wise comparison within MMRM at week 4.|Null hypothesis of change from Baseline in PANSS total score of aripiprazole IM depot 400/300mg group is same as that of placebo group was tested. The sample size estimated a 1:1 randomization ratio (aripiprazole IM depot 400/300mg: placebo) to achieve 90% power and to preserve a nominal alpha level of 0.05 given a treatment difference of -7.5 points in change from Baseline with standard deviation of 20 points between aripiprazole and placebo using a two-sided z-test.||-5.6|-12.8|<.0001
72389038|NCT01663532|144286223|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.1|||<|0.0001|TWO_SIDED|95.0|-15.0|-7.3||Kenward-Rodger degree of freedom was used to test the treatment effects and p-value was not adjusted as this is a primary efficacy endpoint.|Mixed Models Analysis|MMRM analysis with treatment, pooled centers, Week and treatment-by-Week, and Baseline-by-Week interaction as an unstructured covariate was performed.|Difference in Least Square (LS) mean of change and 95% Confidence interval were derived from pair-wise comparison within MMRM at Week 6.|Null hypothesis of change from Baseline in PANSS total score of aripiprazole IM depot 400/300mg group is same as that of placebo group was tested. The sample size estimated a 1:1 randomization ratio (aripiprazole IM depot 400/300mg: placebo) to achieve 90% power and to preserve a nominal alpha level of 0.05 given a treatment difference of -7.5 points in change from Baseline with standard deviation of 20 points between aripiprazole and placebo using a two-sided z-test.||-7.3|-15.0|<.0001
72389039|NCT01663532|144286223|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.0|||<|0.0001|TWO_SIDED|95.0|-18.4|-9.6||Kenward-Rodger degree of freedom was used to test the treatment effects and p-value was not adjusted as this is a primary efficacy endpoint.|Mixed Models Analysis|MMRM analysis with treatment, pooled centers, Week and treatment-by-Week, and Baseline-by-Week interaction as an unstructured covariate was performed.|Difference in Least Square (LS) mean of change and 95% Confidence interval were derived from pair-wise comparison within MMRM at Week 8.|Null hypothesis of change from Baseline in PANSS total score of aripiprazole IM depot 400/300mg group is same as that of placebo group was tested. The sample size estimated a 1:1 randomization ratio (aripiprazole IM depot 400/300mg: placebo) to achieve 90% power and to preserve a nominal alpha level of 0.05 given a treatment difference of -7.5 points in change from Baseline with standard deviation of 20 points between aripiprazole and placebo using a two-sided z-test.||-9.6|-18.4|<.0001
72444240|NCT05568004|144402616|SUPERIORITY|||||||0.001||||||A p-value of \< 0.05 was considered statistically significant for all analyses.Two-tailed testing was used in nature of hypothesis testing.|ANOVA|p value for change over time within the group, Friedman 2-way ANOVA test was applied.|||Statistical analysis was conducted by a researcher using the Statistical Package for Social Sciences (SPSS) version 26.0. The Shapiro-Wilk test and histograms evaluated the data for normal distribution, and the Levene test confirmed homogeneous variances between groups (p \> 0.05). Continuous data following a normal distribution are presented as mean ± standard deviation (SD). The independent samples t test or Mann-Whitney U test was used to compare independent continuous data between groups, while the chi-square or Fisher's exact test was used to compare categorical data. Friedman two-way ANOVA was used to analyze dependent variables, while the two-way mixed ANOVA was used to examine the changes between groups over time. Before the two-way mixed ANOVA, boxplot evaluation confirmed no outliers. Mauchly's sphericity test showed that the assumption of sphericity for two-way interaction was met. Tukey's correction was used for pairwise subgroup comparisons.|||0.001
72444241|NCT05568004|144402616|SUPERIORITY|||||||0.001|||||||ANOVA|p value for change over time within the group, Friedman 2-way ANOVA test was applied.||A p-value of \< 0.05 was considered statistically significant for all analyses.Two-tailed testing was used in nature of hypothesis testing.||||0.001
72444242|NCT05568004|144402616|SUPERIORITY|||||||0.166||||||A p-value of \< 0.05 was considered statistically significant for all analyses.Two-tailed testing was used in nature of hypothesis testing.|ANOVA|p value for change over time within the group, Friedman 2-way ANOVA test was applied.||||||0.166
72444243|NCT05568004|144402617|SUPERIORITY|||||||0.074||||||A p-value of \< 0.05 was considered statistically significant for all analyses.Two-tailed testing was used in nature of hypothesis testing.|ANOVA|p value for change over time within the group, Friedman 2-way ANOVA test was applied.||Statistical Package for Social Sciences (SPSS) 26.0 package program was used to analyze the data. The suitability of normal distribution of the data was evaluated with Shapiro Wilk and histograms. Numerical data complying with normal distribution are presented as mean±standard deviation (SD). . Friedman 2-way ANOVA was used to analyze dependent variables. Two-way mixed ANOVA test was used to examine the changes between groups over time||||0.074
72444244|NCT05568004|144402617|SUPERIORITY|A p-value of \< 0.05 was considered statistically significant for all analyses.Two-tailed testing was used in nature of hypothesis testing.||||||0.074|||||||ANOVA|p value for change over time within the group, Friedman 2-way ANOVA test was applied.||||||0.074
72444245|NCT05568004|144402617|SUPERIORITY|||||||0.311||||||A p-value of \< 0.05 was considered statistically significant for all analyses.|ANOVA|p value for change over time within the group, Friedman 2-way ANOVA test was applied.||||||0.311
72444246|NCT05568004|144402618|SUPERIORITY|||||||0.018||||||A p-value of \< 0.05 was considered statistically significant for all analyses.|ANOVA|\*p-value for changes over time within the group; Friedman's two-way ANOVA test was applied.||Statistical Package for Social Sciences (SPSS) 26.0 package program was used to analyze the data. The suitability of normal distribution of the data was evaluated with Shapiro Wilk and histograms. Numerical data complying with normal distribution are presented as mean±standard deviation (SD). . Friedman 2-way ANOVA was used to analyze dependent variables. Two-way mixed ANOVA test was used to examine the changes between groups over time||||0.018
72444247|NCT05568004|144402618|SUPERIORITY|||||||0.152||||||A p-value of \< 0.05 was considered statistically significant for all analyses.|ANOVA|\*p-value for changes over time within the group; Friedman's two-way ANOVA test was applied.||||||0.152
72444248|NCT05568004|144402618|SUPERIORITY|||||||0.438||||||A p-value of \< 0.05 was considered statistically significant for all analyses.|ANOVA|\*p-value for changes over time within the group; Friedman's two-way ANOVA test was applied||||||0.438
72497240|NCT00880750|144524320|SUPERIORITY_OR_OTHER_LEGACY||Ratio of geometric LS means|1.26||||||90.0|1.2|1.33|||Mixed Models Analysis|After application of the log transformation Cmax was analysed using a mixed effect linear model.||The LS means and associated SEs for granules and tablets as well as the difference between granules and tablets were determined. From the LS mean and SE of the difference, a 90% CI was constructed for the difference of the logs of granules and tablets. An exponential transformation was applied to the lower and upper limits of the CI. This created a point estimate and 90% CI for the ratio of LS means for granules to tablets.||1.33|1.20|
72497241|NCT00880750|144524321|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|0.01||||||90.0|0.0|0.5|||Wilcoxon (Hodges-Lehmann)|The median difference and 90% CI for the median difference was then calculated based on Hodges-Lehmann estimate for Wilcoxon's Signed Rank test||||0.50|0.00|
72497242|NCT00670007|144524326|SUPERIORITY_OR_OTHER||Difference in lung density(adjusted P15)|-0.279|||=|0.752|TWO_SIDED|95.0|-1.089|0.53||A 1-sided P-value \< 0.025 and a positive estimate of the treatment difference Early Start minus Delayed Start (ie, the lower bound of the 95% confidence interval \[CI\] being \> zero) will indicate superiority of Early Start compared with Delayed Start.|Regression, Linear|||Analysis of the annual rate of change in lung density (for TLC + FRC combined) was a linear random regression model with country, inspiration state, time since Day 1 \[CE1226\_4001\], and treatment-by time interaction as fixed effects and subject and subject-by-time interaction as random coefficients at a 1-sided significance level of 0.025.||0.530|-1.089|= 0.752
72497243|NCT00670007|144524326|SUPERIORITY_OR_OTHER||Difference in lung density(adjusted P15)|-0.371|||=|0.823|TWO_SIDED|95.0|-1.159|0.417||A 1-sided P-value \< 0.025 and a positive estimate of the treatment difference Early Start minus Delayed Start (ie, the lower bound of the 95% CI being \> zero) will indicate superiority of Early Start compared with Delayed Start.|Regression, Linear|||Analysis of the annual rate of change in lung density (for TLC) was a linear random regression model with country, time since Day 1 \[CE1226\_4001\], and treatment-by-time interaction as fixed effects and subject and subject-by-time interaction as random coefficients at a 1-sided significance level of 0.025.||0.417|-1.159|= 0.823
72560238|NCT01559116|144651147|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.338|STANDARD_ERROR_OF_MEAN|0.017|<|0.0001|TWO_SIDED|95.0|0.305|0.371|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Placebo is calculated.|||0.371|0.305|<0.0001
72619174|NCT05463705|144769040|EQUIVALENCE|We estimated that 178 providers caring for 1,249 eligible patients would provide 80% power to observe an 11 percentage-point difference in prescribing rates between each intervention arm and control, assuming a control arm prescribing rate of 30%, an ICC of 0.07 (estimated based on prior studies in this system), an average of 7 patients per provider, and a type I error rate of 5%.|Odds Ratio (OR)|0.91|||||TWO_SIDED|95.0|0.64|1.3||||||||1.30|0.64|
72619175|NCT05463705|144769041|SUPERIORITY||Difference in HbA1c %|0.18|||||TWO_SIDED|95.0|-0.07|0.43||||||||0.43|-0.07|
72619176|NCT05463705|144769041|SUPERIORITY||Difference in HbA1c %|0.06|||||TWO_SIDED|95.0|-0.22|0.34||||||||0.34|-0.22|
72619177|NCT04299425|144769054|SUPERIORITY|||||||0.04|||||||t-test, 2 sided|||||||0.04
72619178|NCT04299425|144769055|SUPERIORITY|||||||1|||||||Chi-squared|||||||1.0
72619179|NCT04299425|144769057|SUPERIORITY|||||||0.55|||||||t-test, 2 sided|||||||0.55
72444249|NCT05568004|144402619|SUPERIORITY|||||||0.135||||||A p-value of \< 0.05 was considered statistically significant for all analyses.|ANOVA|\*p-value for changes over time within the group; Friedman's two-way ANOVA test was applied||Statistical Package for Social Sciences (SPSS) 26.0 package program was used to analyze the data. The suitability of normal distribution of the data was evaluated with Shapiro Wilk and histograms. Numerical data complying with normal distribution are presented as mean±standard deviation (SD). . Friedman 2-way ANOVA was used to analyze dependent variables. Two-way mixed ANOVA test was used to examine the changes between groups over time||||0.135
72444250|NCT05568004|144402619|SUPERIORITY|||||||0.203||||||A p-value of \< 0.05 was considered statistically significant for all analyses.|ANOVA|\*p-value for changes over time within the group; Friedman's two-way ANOVA test was applied||||||0.203
72444251|NCT05568004|144402619|SUPERIORITY|||||||0.593||||||A p-value of \< 0.05 was considered statistically significant for all analyses.|ANOVA|\*p-value for changes over time within the group; Friedman's two-way ANOVA test was applied||||||0.593
72444252|NCT05568004|144402620|SUPERIORITY|||||||0.001||||||A p-value of \< 0.05 was considered statistically significant for all analyses.|ANOVA|\*p-value for changes over time within the group; Friedman's two-way ANOVA test was applied.||Statistical Package for Social Sciences (SPSS) 26.0 package program was used to analyze the data. The suitability of normal distribution of the data was evaluated with Shapiro Wilk and histograms. Numerical data complying with normal distribution are presented as mean±standard deviation (SD). . Friedman 2-way ANOVA was used to analyze dependent variables. Two-way mixed ANOVA test was used to examine the changes between groups over time||||0.001
72444253|NCT05568004|144402620|SUPERIORITY|||||||0.021||||||A p-value of \< 0.05 was considered statistically significant for all analyses.|ANOVA|\*p-value for changes over time within the group; Friedman's two-way ANOVA test was applied.||||||0.021
72444254|NCT05568004|144402620|SUPERIORITY|||||||0.081||||||A p-value of \< 0.05 was considered statistically significant for all analyses.|ANOVA|\*p-value for changes over time within the group; Friedman's two-way ANOVA test was applied.||||||0.081
72444255|NCT05568004|144402621|SUPERIORITY||||||<|0.001||||||A p-value of \< 0.05 was considered statistically significant for all analyses.|ANOVA|\*p-value for changes over time within the group; Friedman's two-way ANOVA test was applied.||Statistical Package for Social Sciences (SPSS) 26.0 package program was used to analyze the data. The suitability of normal distribution of the data was evaluated with Shapiro Wilk and histograms. Numerical data complying with normal distribution are presented as mean±standard deviation (SD). . Friedman 2-way ANOVA was used to analyze dependent variables. Two-way mixed ANOVA test was used to examine the changes between groups over time||||<0.001
72444256|NCT05568004|144402621|SUPERIORITY||||||<|0.001||||||A p-value of \< 0.05 was considered statistically significant for all analyses.|ANOVA|\*p-value for changes over time within the group; Friedman's two-way ANOVA test was applied.||||||<0.001
72444257|NCT05568004|144402621|SUPERIORITY|||||||0.747||||||A p-value of \< 0.05 was considered statistically significant for all analyses.|ANOVA|\*p-value for changes over time within the group; Friedman's two-way ANOVA test was applied.||||||0.747
72619180|NCT04299425|144769058|SUPERIORITY|||||||0.36|||||||Chi-squared|||||||0.36
72619181|NCT01655069|144769067|OTHER||Adjusted change from baseline|-0.95|STANDARD_ERROR_OF_MEAN|0.12|||TWO_SIDED|95.0|-1.19|-0.71|||Repeated Measures ANCOVA|Duration of solifenacin treatment: 3 weeks||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant."||-0.71|-1.19|
72619182|NCT01655069|144769067|OTHER||Adjusted change from baseline|-1.11|STANDARD_ERROR_OF_MEAN|0.12|||TWO_SIDED|95.0|-1.34|-0.88|||Repeated Measures ANCOVA|Duration of solifenacin treatment: 6 weeks||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant."||-0.88|-1.34|
72619183|NCT01655069|144769067|OTHER||Adjusted change from baseline|-1.26|STANDARD_ERROR_OF_MEAN|0.13|||TWO_SIDED|95.0|-1.53|-1.0|||Repeated Measures ANCOVA|Duration of solifenacin treatment: 9 weeks||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant."||-1.00|-1.53|
72619184|NCT01655069|144769067|OTHER||Adjusted change from baseline|-1.39|STANDARD_ERROR_OF_MEAN|0.12|||TWO_SIDED|95.0|-1.63|-1.16|||Repeated Measures ANCOVA|Duration of solifenacin treatment: 12 weeks||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant."||-1.16|-1.63|
72619185|NCT01655069|144769067|OTHER||Adjusted change from baseline|-1.54|STANDARD_ERROR_OF_MEAN|0.11|||TWO_SIDED|95.0|-1.76|-1.32|||Repeated Measures ANCOVA|Duration of solifenacin treatment: 24 weeks||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant."||-1.32|-1.76|
72619186|NCT01655069|144769067|OTHER||Adjusted change from baseline|-1.56|STANDARD_ERROR_OF_MEAN|0.13|||TWO_SIDED|95.0|-1.81|-1.31|||Repeated Measures ANCOVA|Duration of solifenacin treatment: 40 weeks||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant"||-1.31|-1.81|
72619187|NCT01655069|144769067|OTHER||Adjusted change from baseline|-1.93|STANDARD_ERROR_OF_MEAN|0.13|||TWO_SIDED|95.0|-2.19|-1.67|||Repeated Measures ANCOVA|Duration of solifenacin treatment: 52 weeks||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant."||-1.67|-2.19|
72619188|NCT01655069|144769067|OTHER||Adjusted change from baseline|-0.93|STANDARD_ERROR_OF_MEAN|0.35|||TWO_SIDED|95.0|-1.62|-0.23|||Repeated Measures ANCOVA|Duration of solifenacin treatment: 3 weeks||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant."||-0.23|-1.62|
72444258|NCT05568004|144402622|SUPERIORITY|||||||0.001||||||A p-value of \< 0.05 was considered statistically significant for all analyses.|ANOVA|\*p-value for changes over time within the group; Friedman's two-way ANOVA test was applied.||Statistical Package for Social Sciences (SPSS) 26.0 package program was used to analyze the data. The suitability of normal distribution of the data was evaluated with Shapiro Wilk and histograms. Numerical data complying with normal distribution are presented as mean±standard deviation (SD). . Friedman 2-way ANOVA was used to analyze dependent variables. Two-way mixed ANOVA test was used to examine the changes between groups over time||||0.001
72444259|NCT05568004|144402622|SUPERIORITY||||||<|0.001||||||A p-value of \< 0.05 was considered statistically significant for all analyses.|ANOVA|p-value for changes over time within the group; Friedman's two-way ANOVA test was applied.||||||<0.001
72444260|NCT05568004|144402622|SUPERIORITY|||||||0.05||||||A p-value of \< 0.05 was considered statistically significant for all analyses.|ANOVA|p-value for changes over time within the group; Friedman's two-way ANOVA test was applied.||||||0.05
72444261|NCT05919082|144402625|OTHER||Odds Ratio (OR)|1.4||||0.0438|TWO_SIDED|95.0|1.01|1.99|||Regression, Logistic||The odds ratio and p-value are obtained by logistic regression model, adjusted for baseline PGA. Wald CI was presented.|||1.99|1.01|0.0438
72444262|NCT05919082|144402626|OTHER||Odds Ratio (OR)|1.5||||0.0108|TWO_SIDED|95.0|1.1|2.12|||Regression, Logistic||The odds ratio and p-value were obtained by logistic regression model, adjusted for baseline PGA and baseline mPASI score. Wald CI was presented.|||2.12|1.10|0.0108
72444263|NCT05919082|144402627|OTHER||Odds Ratio (OR)|1.5||||0.0199|TWO_SIDED|95.0|1.07|2.19|||Regression, Logistic||The odds ratio and p-value were obtained by logistic regression model, adjusted for baseline PGA and baseline mPASI score. Wald CI was presented.|||2.19|1.07|0.0199
72444264|NCT03526861|144402649|SUPERIORITY|Primary endpoint tested sequentially at a 5% significance level|Risk Difference (RD)|13.8||||0.002|TWO_SIDED|95.0|5.3|22.3||Based on the primary analysis of the primary estimand 'composite'.|Cochran-Mantel-Haenszel||Mantel-Haenszel risk difference, stratified by region and baseline disease severity.|Subjects with IGA score of 0 (clear) or 1 (almost clear) at Week 16 were considered responders. Subjects with missing data or subjects who received rescue medication from Week 2 to Week 16 were considered non-responders. Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity. The null hypothesis of no difference in response rate between tralokinumab 300 mg Q2W and placebo was tested against the 2-sided alternative that there is a difference.||22.3|5.3|0.002
72444265|NCT03526861|144402649|SUPERIORITY|Primary endpoint tested sequentially at a 5% significance level|Risk Difference (RD)|17.5|||<|0.001|TWO_SIDED|95.0|8.4|26.6||Based on the primary analysis of the primary estimand 'composite'.|Cochran-Mantel-Haenszel||Mantel-Haenszel risk difference, stratified by region and baseline disease severity.|Subjects with IGA score of 0 (clear) or 1 (almost clear) at Week 16 were considered responders. Subjects with missing data or subjects who received rescue medication from Week 2 to Week 16 were considered non-responders. Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity. The null hypothesis of no difference in response rate between tralokinumab 150 mg Q2W and placebo was tested against the 2-sided alternative that there is a difference.||26.6|8.4|<0.001
72444266|NCT03526861|144402650|SUPERIORITY|Primary endpoint tested sequentially at a 5% significance level|Risk Difference (RD)|22.0|||<|0.001|TWO_SIDED|95.0|12.0|32.0||Based on the primary analysis of the primary estimand 'composite'.|Cochran-Mantel-Haenszel||Mantel-Haenszel risk difference, stratified by region and baseline disease severity.|Subjects who achieved at least 75% reduction in EASI at Week 16 were considered responders. Subjects with missing data or subjects who received rescue medication from Week 2 to Week 16 were considered non-responders. Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity. The null hypothesis of no difference in response rate between tralokinumab 300 mg Q2W and placebo was tested against the 2-sided alternative that there is a difference.||32.0|12.0|<0.001
72444267|NCT03526861|144402650|SUPERIORITY|Primary endpoint tested sequentially at a 5% significance level|Risk Difference (RD)|22.5|||<|0.001|TWO_SIDED|95.0|12.4|32.6||Based on the primary analysis of the primary estimand 'composite'.|Cochran-Mantel-Haenszel||Mantel-Haenszel risk difference, stratified by region and baseline disease severity.|Subjects who achieved at least 75% reduction in EASI at Week 16 were considered responders. Subjects with missing data or subjects who received rescue medication from Week 2 to Week 16 were considered non-responders. Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity. The null hypothesis of no difference in response rate between tralokinumab 150 mg Q2W and placebo was tested against the 2-sided alternative that there is a difference.||32.6|12.4|<0.001
72469441|NCT04750577|144462631|OTHER||Mean Difference (Net)|-0.063||||0.5616|TWO_SIDED|95.0|-0.275|0.15|||Mixed-effect Model Repeat Measurement||"Least Squares Mean of 2 mg BI 685509 TID- Least Squares Mean of Placebo"|Least Square Means difference and 95% confidence interval were estimated by restricted maximum likelihood based Mixed-effect Model for Repeated Measures ((REML)-based MMRM) including the fixed, categorical effects of treatment at each visit (baseline, Week 6, Week 12 and Week 20), and the continuous effect of baseline at each visit (Week 6, Week 12 and Week 20) as well as random effects of patient.||0.150|-0.275|0.5616
72444268|NCT03526861|144402651|SUPERIORITY|Secondary endpoint tested sequentially at a 2.5% significance level|Risk Difference (RD)|21.7|||<|0.001|TWO_SIDED|95.0|12.3|31.1||Based on the primary analysis of the primary estimand 'composite'.|Cochran-Mantel-Haenszel||Mantel-Haenszel risk difference, stratified by region and baseline disease severity.|Subjects with at least 4-point reduction in Adolescent Worst Pruritus NRS were considered responders. Subjects with missing data or who received rescue medication from Week 2 to Week 16 were considered non-responders. Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity. The null hypothesis of no difference in response rate between tralokinumab 300 mg Q2W and placebo was tested against the 2-sided alternative that there is a difference.||31.1|12.3|<0.001
72497244|NCT00670007|144524326|SUPERIORITY_OR_OTHER||Difference in lung density(adjusted P15)|-0.176|||=|0.648|TWO_SIDED|95.0|-1.09|0.738||A 1-sided P-value \< 0.025 and a positive estimate of the treatment difference Early Start minus Delayed Start (ie, the lower bound of the 95% CI being \> zero) will indicate superiority of Early Start compared with Delayed Start.|Regression, Linear|||Analysis of the annual rate of change in lung density (for FRC) was a linear random regression model with country, time since Day 1 \[CE1226\_4001\], and treatment-by-time interaction as fixed effects and subject and subject-by-time interaction as random coefficients at a 1-sided significance level of 0.025.||0.738|-1.09|= 0.648
72444269|NCT03526861|144402651|SUPERIORITY|Secondary endpoint tested sequentially at a 5% significance level|Risk Difference (RD)|19.9|||<|0.001|TWO_SIDED|95.0|10.6|29.2||Based on the primary analysis of the primary estimand 'composite'.|Cochran-Mantel-Haenszel||Mantel-Haenszel risk difference, stratified by region and baseline disease severity.|Subjects with at least 4-point reduction in Adolescent Worst Pruritus NRS were considered responders. Subjects with missing data or who received rescue medication from Week 2 to Week 16 were considered non-responders. Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity. The null hypothesis of no difference in response rate between tralokinumab 150 mg Q2W and placebo was tested against the 2-sided alternative that there is a difference.||29.2|10.6|<0.001
72444270|NCT03526861|144402652|SUPERIORITY|This secondary endpoint was tested sequentially using the Holm-Bonferroni method for multiplicity adjustment at a 2.5% significance level after the sequential testing of the primary endpoints and first secondary endpoint, if these showed statistical significance.|Difference of least square means|-19.7|||<|0.001|TWO_SIDED|95.0|-27.1|-12.2||Based on the primary analysis of the primary estimand 'hypothetical'.|Repeated measurements model|||Repeated measurements model on post-baseline data. In case of no post-baseline assessments before initiation of rescue medication, the Week 2 change was imputed as 0. Data collected after permanent discontinuation of IMP or after use of rescue treatment from Week 2 to Week 16 were not included in the analysis.||-12.2|-27.1|<0.001
72444271|NCT03526861|144402652|SUPERIORITY|This secondary endpoint was tested sequentially using the Holm-Bonferroni method for multiplicity adjustment at a 5% significance level after the sequential testing of the primary endpoints and first secondary endpoint, if these showed statistical significance.|Difference of least square means|-18.0|||<|0.001|TWO_SIDED|95.0|-25.6|-10.4||Based on the primary analysis of the primary estimand 'hypothetical'.|Repeated measurements model|||Repeated measurements model on post-baseline data. In case of no post-baseline assessments before initiation of rescue medication, the Week 2 change was imputed as 0. Data collected after permanent discontinuation of IMP or after use of rescue treatment from Week 2 to Week 16 were not included in the analysis.||-10.4|-25.6|<0.001
72444272|NCT03526861|144402653|SUPERIORITY|This secondary endpoint was tested sequentially using the Holm-Bonferroni method for multiplicity adjustment at a 2.5% significance level after the sequential testing of the primary endpoints and first secondary endpoint, if these showed statistical significance.|Difference of least square means|-2.6||||0.007|TWO_SIDED|95.0|-4.5|-0.7||Based on the primary analysis of the primary estimand 'hypothetical'.|Repeated measurements model|||Repeated measurements model on post-baseline data. In case of no post-baseline assessments before initiation of rescue medication, the Week 2 change was imputed as 0. Data collected after permanent discontinuation of IMP or after use of rescue treatment from Week 2 to Week 16 were not included in the analysis.||-0.7|-4.5|0.007
72444273|NCT03526861|144402653|SUPERIORITY|This secondary endpoint was tested sequentially using the Holm-Bonferroni method for multiplicity adjustment at a 5% significance level after the sequential testing of the primary endpoints and first secondary endpoint, if these showed statistical significance.|Difference of least square means|-2.0||||0.04|TWO_SIDED|95.0|-3.9|-0.1||Based on the primary analysis of the primary estimand 'hypothetical'.|Repeated measurements model|||Repeated measurements model on post-baseline data. In case of no post-baseline assessments before initiation of rescue medication, the Week 2 change was imputed as 0. Data collected after permanent discontinuation of IMP or after use of rescue treatment from Week 2 to Week 16 were not included in the analysis.||-0.1|-3.9|0.040
72444274|NCT03526861|144402656|SUPERIORITY|The statistical test was not controlled for multiplicity.|Risk Difference (RD)|38.5|||<|0.001|TWO_SIDED|95.0|26.8|50.2||Based on the primary analysis of the primary estimand 'composite'.|Cochran-Mantel-Haenszel||Mantel-Haenszel risk difference, stratified by region and disease severity.|Subjects who achieved at least 50% reduction in EASI at Week 16 were considered responders. Subjects with missing data or subjects who received rescue medication from Week 2 to Week 16 were considered non-responders. Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity. The null hypothesis of no difference in response rate between tralokinumab 300 mg Q2W and placebo was tested against the 2-sided alternative that there is a difference.||50.2|26.8|<0.001
72497245|NCT00670007|144524327|SUPERIORITY_OR_OTHER||Difference in lung density(adjusted P15)|-0.53||||0.526|TWO_SIDED|95.0|-2.179|1.12||Two-sided P-value|ANCOVA|||Analysis of the change in lung density (for TLC + FRC combined) from baseline to 2 years was analyzed using an ANCOVA model with country, treatment, and baseline lung density as fixed effects and inspiration state as a repeated random effect.||1.120|-2.179|0.526
72497246|NCT00670007|144524327|SUPERIORITY_OR_OTHER||Difference in lung density(adjusted P15)|-0.486||||0.558|TWO_SIDED|95.0|-2.126|1.154||Two-sided P-value|ANCOVA|||Analysis of the change in lung density (for TLC) from baseline to 2 years was analyzed using an ANCOVA model with country, treatment, and baseline lung density as fixed effects.||1.154|-2.126|0.558
72497247|NCT00670007|144524327|SUPERIORITY_OR_OTHER||Difference in lung density(adjusted P15)|0.019||||0.984|TWO_SIDED|95.0|-1.858|1.895||Two-sided P-value|ANCOVA|||Analysis of the change in lung density (for FRC) from baseline to 2 years was analyzed using an ANCOVA model with country, treatment, and baseline lung density as fixed effects.||1.895|-1.858|0.984
72560239|NCT01559116|144651147|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.12|STANDARD_ERROR_OF_MEAN|0.017|<|0.0001|TWO_SIDED|95.0|0.087|0.153|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Olodaterol (5 µg) is calculated.|||0.153|0.087|<0.0001
72560240|NCT01559116|144651147|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.111|STANDARD_ERROR_OF_MEAN|0.017|<|0.0001|TWO_SIDED|95.0|0.078|0.143|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Tiotropium high dose (5 µg) is calculated.|||0.143|0.078|<0.0001
72560241|NCT01559116|144651147|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.35|STANDARD_ERROR_OF_MEAN|0.017|<|0.0001|TWO_SIDED|95.0|0.317|0.383|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Placebo is calculated.|||0.383|0.317|<0.0001
72619189|NCT01655069|144769067|OTHER||Adjusted change from baseline|-1.38|STANDARD_ERROR_OF_MEAN|0.36|||TWO_SIDED|95.0|-2.09|-0.68|||Repeated Measures ANCOVA|Duration of solifenacin treatment: 6 weeks||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant"||-0.68|-2.09|
72444275|NCT03526861|144402656|SUPERIORITY|The statistical test was not controlled for multiplicity.|Risk Difference (RD)|32.4|||<|0.001|TWO_SIDED|95.0|20.6|44.1||Based on the primary analysis of the primary estimand 'composite'.|Cochran-Mantel-Haenszel||Mantel-Haenszel risk difference, stratified by region and disease severity.|Subjects who achieved at least 50% reduction in EASI at Week 16 were considered responders. Subjects with missing data or subjects who received rescue medication from Week 2 to Week 16 were considered non-responders. Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity. The null hypothesis of no difference in response rate between tralokinumab 150 mg Q2W and placebo was tested against the 2-sided alternative that there is a difference.||44.1|20.6|<0.001
72444276|NCT03526861|144402657|SUPERIORITY|The statistical test was not controlled for multiplicity.|Risk Difference (RD)|13.7||||0.002|TWO_SIDED|95.0|5.2|22.2||Based on the primary analysis of the primary estimand 'composite'.|Cochran-Mantel-Haenszel||Mantel-Haenszel risk difference, stratified by region and disease severity.|Subjects who achieved at least 90% reduction in EASI at Week 16 were considered responders. Subjects with missing data or subjects who received rescue medication from Week 2 to Week 16 were considered non-responders. Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity. The null hypothesis of no difference in response rate between tralokinumab 300 mg Q2W and placebo was tested against the 2-sided alternative that there is a difference.||22.2|5.2|0.002
72444277|NCT03526861|144402657|SUPERIORITY|The statistical test was not controlled for multiplicity.|Risk Difference (RD)|15.3|||<|0.001|TWO_SIDED|95.0|6.5|24.1||Based on the primary analysis of the primary estimand 'composite'.|Cochran-Mantel-Haenszel||Mantel-Haenszel risk difference, stratified by region and disease severity.|Subjects who achieved at least 90% reduction in EASI at Week 16 were considered responders. Subjects with missing data or subjects who received rescue medication from Week 2 to Week 16 were considered non-responders. Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity. The null hypothesis of no difference in response rate between tralokinumab 150 mg Q2W and placebo was tested against the 2-sided alternative that there is a difference.||24.1|6.5|<0.001
72444278|NCT03526861|144402658|SUPERIORITY|The statistical test was not controlled for multiplicity.|Difference of least square means|-9.4|||<|0.001|TWO_SIDED|95.0|-13.5|-5.3||Based on the primary analysis of the primary estimand 'hypothetical'.|Repeated measurements model|||Repeated measurements model on post-baseline data. In case of no post-baseline assessments before initiation of rescue medication, the Week 2 change was imputed as 0. Data collected after permanent discontinuation of IMP or after use of rescue treatment from Week 2 to Week 16 were not included in the analysis.||-5.3|-13.5|<0.001
72444279|NCT03526861|144402658|SUPERIORITY|The statistical test was not controlled for multiplicity.|Difference of least square means|-9.4|||<|0.001|TWO_SIDED|95.0|-13.6|-5.3||Based on the primary analysis of the primary estimand 'hypothetical'.|Repeated measurements model|||Repeated measurements model on post-baseline data. In case of no post-baseline assessments before initiation of rescue medication, the Week 2 change was imputed as 0. Data collected after permanent discontinuation of IMP or after use of rescue treatment from Week 2 to Week 16 were not included in the analysis.||-5.3|-13.6|<0.001
72444280|NCT03526861|144402659|SUPERIORITY|The statistical test was not controlled for multiplicity.|Risk Difference (RD)|11.5||||0.002|TWO_SIDED|95.0|4.5|18.4||Based on the primary analysis of the primary estimand 'composite'.|Cochran-Mantel-Haenszel||Mantel-Haenszel risk difference, stratified by region and disease severity.|Subjects who achieved at least 75% reduction in SCORAD at Week 16 were considered responders. Subjects with missing data or subjects who received rescue medication from Week 2 to Week 16 were considered non-responders. Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity. The null hypothesis of no difference in response rate between tralokinumab 300 mg Q2W and placebo was tested against the 2-sided alternative that there is a difference.||18.4|4.5|0.002
72560242|NCT01559116|144651147|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.131|STANDARD_ERROR_OF_MEAN|0.017|<|0.0001|TWO_SIDED|95.0|0.098|0.164|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Olodaterol (5 µg) is calculated.|||0.164|0.098|<0.0001
72560243|NCT01559116|144651147|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.132|STANDARD_ERROR_OF_MEAN|0.017|<|0.0001|TWO_SIDED|95.0|0.099|0.165|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Tiotropium low dose (2.5 µg) is calculated.|||0.165|0.099|<0.0001
72444281|NCT03526861|144402659|SUPERIORITY|The statistical test was not controlled for multiplicity.|Risk Difference (RD)|15.6|||<|0.001|TWO_SIDED|95.0|7.8|23.3||Based on the primary analysis of the primary estimand 'composite'.|Cochran-Mantel-Haenszel||Mantel-Haenszel risk difference, stratified by region and disease severity.|Subjects who achieved at least 75% reduction in SCORAD at Week 16 were considered responders. Subjects with missing data or subjects who received rescue medication from Week 2 to Week 16 were considered non-responders. Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity. The null hypothesis of no difference in response rate between tralokinumab 150 mg Q2W and placebo was tested against the 2-sided alternative that there is a difference.||23.3|7.8|<0.001
72444282|NCT03526861|144402660|SUPERIORITY|The statistical test was not controlled for multiplicity.|Risk Difference (RD)|26.2|||<|0.001|TWO_SIDED|95.0|16.1|36.3||Based on the primary analysis of the primary estimand 'composite'.|Cochran-Mantel-Haenszel||Mantel-Haenszel risk difference, stratified by region and disease severity.|Subjects who achieved at least 50% reduction in SCORAD at Week 16 were considered responders. Subjects with missing data or subjects who received rescue medication from Week 2 to Week 16 were considered non-responders. Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity. The null hypothesis of no difference in response rate between tralokinumab 300 mg Q2W and placebo was tested against the 2-sided alternative that there is a difference.||36.3|16.1|<0.001
72469442|NCT04750577|144462631|OTHER||Mean Difference (Net)|-0.251||||0.0183|TWO_SIDED|95.0|-0.459|-0.043|||Mixed-effect Model Repeat Measurement||"Least Squares Mean of 3 mg BI 685509 TID- Least Squares Mean of Placebo"|Least Square Means difference and 95% confidence interval were estimated by restricted maximum likelihood based Mixed-effect Model for Repeated Measures ((REML)-based MMRM) including the fixed, categorical effects of treatment at each visit (baseline, Week 6, Week 12 and Week 20), and the continuous effect of baseline at each visit (Week 6, Week 12 and Week 20) as well as random effects of patient.||-0.043|-0.459|0.0183
72469443|NCT04750577|144462632|OTHER||Mean Difference (Net)|-0.211||||0.0396|TWO_SIDED|0.95|-0.413|-0.01|||Mixed Models Analysis||"Least Squares Mean of 1 mg BI 685509 TID- Least Squares Mean of Placebo"|Least Square Means difference and 95% confidence interval were estimated by restricted maximum likelihood based Mixed-effect Model for Repeated Measures ((REML)-based MMRM) including the fixed, categorical effects of treatment at each visit (baseline, Week 6, Week 12 and Week 20), and the continuous effect of baseline at each visit (Week 6, Week 12 and Week 20) as well as random effects of patient.||-0.010|-0.413|0.0396
72469444|NCT04750577|144462632|OTHER||Mean Difference (Net)|-0.12||||0.2568|TWO_SIDED|0.95|-0.327|0.088|||Mixed Models Analysis||"Least Squares Mean of 2 mg BI 685509 TID- Least Squares Mean of Placebo"|Least Square Means difference and 95% confidence interval were estimated by restricted maximum likelihood based Mixed-effect Model for Repeated Measures ((REML)-based MMRM) including the fixed, categorical effects of treatment at each visit (baseline, Week 6, Week 12 and Week 20), and the continuous effect of baseline at each visit (Week 6, Week 12 and Week 20) as well as random effects of patient.||0.088|-0.327|0.2568
72469445|NCT04750577|144462632|OTHER||Mean Difference (Net)|-0.357||||0.0006|TWO_SIDED|0.95|-0.56|-0.154|||Mixed Models Analysis||"Least Squares Mean of 3 mg BI 685509 TID- Least Squares Mean of Placebo"|Least Square Means difference and 95% confidence interval were estimated by restricted maximum likelihood based Mixed-effect Model for Repeated Measures ((REML)-based MMRM) including the fixed, categorical effects of treatment at each visit (baseline, Week 6, Week 12 and Week 20), and the continuous effect of baseline at each visit (Week 6, Week 12 and Week 20) as well as random effects of patient.||-0.154|-0.560|0.0006
72469446|NCT04750577|144462633|OTHER||Odds Ratio (OR)|2.25||||0.0519|TWO_SIDED|95.0|0.99|5.1|||Regression, Logistic||Odds Ratio was calculated as BI 685509/ Placebo.|Treatment, sodium-Glucose co-Transporter-2 Inhibitor (SGLT2i) use at baseline, and type of diabetes were used as covariates in the logistic regression model.||5.10|0.99|0.0519
72469447|NCT04750577|144462633|OTHER||Odds Ratio (OR)|1.43||||0.4159|TWO_SIDED|95.0|0.61|3.36|||Regression, Logistic||Odds Ratio was calculated as BI 685509/ Placebo.|Treatment, sodium-Glucose co-Transporter-2 Inhibitor (SGLT2i) use at baseline, and type of diabetes were used as covariates in the logistic regression model.||3.36|0.61|0.4159
72469448|NCT04750577|144462633|OTHER||Odds Ratio (OR)|2.9||||0.0106|TWO_SIDED|95.0|1.28|6.55|||Regression, Logistic||Odds Ratio was calculated as BI 685509/ Placebo.|Treatment, sodium-Glucose co-Transporter-2 Inhibitor (SGLT2i) use at baseline, and type of diabetes were used as covariates in the logistic regression model.||6.55|1.28|0.0106
72469449|NCT04750577|144462634|OTHER||Odds Ratio (OR)|2.79||||0.0176|TWO_SIDED|95.0|1.2|6.53|||Regression, Logistic||Odds Ratio was calculated as BI 685509/ Placebo.|Treatment, sodium-Glucose co-Transporter-2 Inhibitor (SGLT2i) use at baseline, and type of diabetes were used as covariates in the logistic regression model.||6.53|1.20|0.0176
72469450|NCT04750577|144462634|OTHER||Odds Ratio (OR)|1.32||||0.5467|TWO_SIDED|95.0|0.53|3.29|||Regression, Logistic||Odds Ratio was calculated as BI 685509/ Placebo.|Treatment, sodium-Glucose co-Transporter-2 Inhibitor (SGLT2i) use at baseline, and type of diabetes were used as covariates in the logistic regression model.||3.29|0.53|0.5467
72469451|NCT04750577|144462634|OTHER||Odds Ratio (OR)|4.46||||0.0005|TWO_SIDED|95.0|1.91|10.39|||Regression, Logistic||Odds Ratio was calculated as BI 685509/ Placebo.|Treatment, sodium-Glucose co-Transporter-2 Inhibitor (SGLT2i) use at baseline, and type of diabetes were used as covariates in the logistic regression model.||10.39|1.91|0.0005
72469452|NCT01310699|144462661|SUPERIORITY|||||||0.21|||||||Chi-squared|||||||0.21
72469453|NCT01310699|144462662|SUPERIORITY|||||||0.18|||||||Chi-squared|||||||0.18
72469454|NCT02633397|144462670|SUPERIORITY|||||||0.19|||||||Regression, Logistic|||P- Value was the exact logistic regression adjusted for clinical site.||||0.19
72469455|NCT02633397|144462671|SUPERIORITY|||||||0.42|||||||Regression, Logistic|||P- Value was the exact logistic regression adjusted for clinical site.||||0.42
72469456|NCT02633397|144462672|SUPERIORITY|||||||0.52|||||||Regression, Logistic|||P- Value was the exact logistic regression adjusted for clinical site.||||0.52
72469457|NCT02633397|144462674|SUPERIORITY||Mean Difference (Final Values)|-0.14||||0.69|TWO_SIDED|90.0|-0.7|0.42|||ANCOVA|||ANCOVA model adjusted for clinic site||0.42|-0.70|0.69
72469458|NCT02633397|144462675|SUPERIORITY||Mean Difference (Final Values)|-39.51||||0.4|TWO_SIDED|90.0|-117.05|38.02|||ANCOVA|||ANCOVA model adjusted for clinic site||38.02|-117.05|0.40
72469459|NCT02633397|144462676|SUPERIORITY||Mean Difference (Final Values)|0.31||||0.23|TWO_SIDED|90.0|-0.11|0.73|||Regression, Linear|||Linear regression model adjusted for clinic site||0.73|-0.11|0.23
72444283|NCT03526861|144402660|SUPERIORITY|The statistical test was not controlled for multiplicity.|Risk Difference (RD)|25.5|||<|0.001|TWO_SIDED|95.0|15.3|35.7||Based on the primary analysis of the primary estimand 'composite'.|Cochran-Mantel-Haenszel||Mantel-Haenszel risk difference, stratified by region and disease severity.|Subjects who achieved at least 50% reduction in SCORAD at Week 16 were considered responders. Subjects with missing data or subjects who received rescue medication from Week 2 to Week 16 were considered non-responders. Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity. The null hypothesis of no difference in response rate between tralokinumab 150 mg Q2W and placebo was tested against the 2-sided alternative that there is a difference.||35.7|15.3|<0.001
72444284|NCT03526861|144402661|SUPERIORITY|The statistical test was not controlled for multiplicity.|Difference of least square means|-1.5|||<|0.001|TWO_SIDED|95.0|-2.4|-0.6||Based on the primary analysis of the primary estimand 'hypothetical'.|Repeated measurements model|||Repeated measurements model on post-baseline data. In case of no post-baseline assessments before initiation of rescue medication, the Week 2 change was imputed as 0. Data collected after permanent discontinuation of IMP or after use of rescue treatment from Week 2 to Week 16 were not included in the analysis.||-0.6|-2.4|<0.001
72619190|NCT01655069|144769067|OTHER||Adjusted change from baseline|-1.4|STANDARD_ERROR_OF_MEAN|0.35|||TWO_SIDED|95.0|-2.09|-0.7|||Repeated Measures ANCOVA|Duration of solifenacin treatment: 9 weeks||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant."||-0.70|-2.09|
72444285|NCT03526861|144402661|SUPERIORITY|The statistical test was not controlled for multiplicity.|Difference of least square means|-1.2||||0.007|TWO_SIDED|95.0|-2.1|-0.3||Based on the primary analysis of the primary estimand 'hypothetical'.|Repeated measurements model|||Repeated measurements model on post-baseline data. In case of no post-baseline assessments before initiation of rescue medication, the Week 2 change was imputed as 0. Data collected after permanent discontinuation of IMP or after use of rescue treatment from Week 2 to Week 16 were not included in the analysis.||-0.3|-2.1|0.007
72444286|NCT03526861|144402662|SUPERIORITY|The statistical test was not controlled for multiplicity.|Risk Difference (RD)|20.3|||<|0.001|TWO_SIDED|95.0|9.7|31.0||Based on the primary analysis of the primary estimand 'composite'.|Cochran-Mantel-Haenszel||Mantel-Haenszel risk difference, stratified by region and disease severity.|Subjects with at least 3-point reduction in Adolescent Worst Pruritus NRS were considered responders. Subjects with missing data or who received rescue medication from Week 2 to Week 16 were considered non-responders. Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity. The null hypothesis of no difference in response rate between tralokinumab 300 mg Q2W and placebo was tested against the 2-sided alternative that there is a difference.||31.0|9.7|<0.001
72444287|NCT03526861|144402662|SUPERIORITY|The statistical test was not controlled for multiplicity.|Risk Difference (RD)|21.8|||<|0.001|TWO_SIDED|95.0|10.9|32.7||Based on the primary analysis of the primary estimand 'composite'.|Cochran-Mantel-Haenszel||Mantel-Haenszel risk difference, stratified by region and disease severity.|Subjects with at least 3-point reduction in Adolescent Worst Pruritus NRS were considered responders. Subjects with missing data or who received rescue medication from Week 2 to Week 16 were considered non-responders. Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity. The null hypothesis of no difference in response rate between tralokinumab 150 mg Q2W and placebo was tested against the 2-sided alternative that there is a difference.||32.7|10.9|<0.001
72444288|NCT03526861|144402663|SUPERIORITY|The statistical test was not controlled for multiplicity.|Difference of least square means|-6.0|||<|0.001|TWO_SIDED|95.0|-8.4|-3.6||Based on the primary analysis of the primary estimand 'hypothetical'.|Repeated measurements model|||Repeated measurements model on post-baseline data. In case of no post-baseline assessments before initiation of rescue medication, the Week 2 change was imputed as 0. Data collected after permanent discontinuation of IMP or after use of rescue treatment from Week 2 to Week 16 were not included in the analysis.||-3.6|-8.4|<0.001
72469460|NCT02633397|144462677|SUPERIORITY||Mean Difference (Final Values)|-0.08||||-0.8|TWO_SIDED|90.0|-0.62|0.46|||ANCOVA|||ANCOVA model adjusted for clinic site||0.46|-0.62|-0.80
72469461|NCT02633397|144462678|SUPERIORITY||Mean Difference (Final Values)|-6.96|||<|0.001|TWO_SIDED|90.0|-10.22|-3.69|||Mixed Models Analysis|||Linear mixed model with random intercept was used to compare the change in MAP as a function of time, the interaction between time and study arm, and clinic site.||-3.69|-10.22|<0.001
72560244|NCT01559116|144651147|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.122|STANDARD_ERROR_OF_MEAN|0.017|<|0.0001|TWO_SIDED|95.0|0.089|0.155|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Tiotropium high dose (5 µg) is calculated.|||0.155|0.089|<0.0001
72560245|NCT01559116|144651148|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.433|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001|TWO_SIDED|95.0|0.389|0.477|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Placebo is calculated.|||0.477|0.389|<0.0001
72560246|NCT01559116|144651148|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.21|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001|TWO_SIDED|95.0|0.166|0.253|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Olodaterol (5 µg) is calculated.|||0.253|0.166|<0.0001
72560247|NCT01559116|144651148|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.177|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001|TWO_SIDED|95.0|0.133|0.221|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Tiotropium high dose (5 µg) is calculated.|||0.221|0.133|<0.0001
72560248|NCT01559116|144651148|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.396|STANDARD_ERROR_OF_MEAN|0.023|<|0.0001|TWO_SIDED|95.0|0.352|0.441|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Placebo is calculated.|||0.441|0.352|<0.0001
72560249|NCT01559116|144651148|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.173|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001|TWO_SIDED|95.0|0.129|0.217|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Olodaterol (5 µg) is calculated.|||0.217|0.129|<0.0001
72560250|NCT01559116|144651148|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.159|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001|TWO_SIDED|95.0|0.115|0.203|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Tiotropium low dose (2.5 µg) is calculated. is calculated.|||0.203|0.115|<0.0001
72560251|NCT01559116|144651148|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.14|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001|TWO_SIDED|95.0|0.096|0.184|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Tiotropium high dose (5 µg) is calculated.|||0.184|0.096|<0.0001
72619191|NCT01655069|144769067|OTHER||Adjusted change from baseline|-1.58|STANDARD_ERROR_OF_MEAN|0.35|||TWO_SIDED|95.0|-2.27|-0.88|||Repeated Measures ANCOVA|Duration of solifenacin treatment: 12 weeks||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant."||-0.88|-2.27|
72389040|NCT01663532|144286223|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.1|||<|0.0001|TWO_SIDED|95.0|-19.4|-10.8||Kenward-Rodger degree of freedom was used to test the treatment effects and p-value was not adjusted as this is a primary efficacy endpoint.|Mixed Models Analysis|MMRM analysis with treatment, pooled centers, Week and treatment-by-Week, and Baseline-by-Week interaction as an unstructured covariate was performed.|Difference in Least Square (LS) mean of change and 95% Confidence interval were derived from pair-wise comparison within MMRM at Week 10.|Null hypothesis of change from Baseline in PANSS total score of aripiprazole IM depot 400/300mg group is same as that of placebo group was tested. The sample size estimated a 1:1 randomization ratio (aripiprazole IM depot 400/300mg: placebo) to achieve 90% power and to preserve a nominal alpha level of 0.05 given a treatment difference of -7.5 points in change from Baseline with standard deviation of 20 points between aripiprazole and placebo using a two-sided z-test.||-10.8|-19.4|<.0001
72389041|NCT01663532|144286224|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3||||0.0001|TWO_SIDED|95.0|-0.4|-0.1||After the comparison for primary efficacy endpoint was statistically significant, the comparison of change from Baseline in CGI severity score was conducted at same alpha level 0.05.|Mixed Models Analysis|MMRM analysis with treatment, pooled centers, Week and treatment-by-Week, and Baseline-by-Week interaction as an unstructured covariate was performed.|Difference in Least Square (LS) mean of change and 95% Confidence interval were derived from pair-wise comparison within MMRM at Week 1.|Null hypothesis of change from Baseline in PANSS total score of aripiprazole IM depot 400/300mg group is same as that of placebo group was tested.||-0.1|-0.4|0.0001
72389042|NCT01663532|144286224|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|||<|0.0001|TWO_SIDED|95.0|-0.6|-0.2||After the comparison for primary efficacy endpoint was statistically significant, the comparison of change from Baseline in CGI severity score was conducted at same alpha level 0.05.|Mixed Models Analysis|MMRM analysis with treatment, pooled centers, Week and treatment-by-Week, and Baseline-by-Week interaction as an unstructured covariate was performed.|Difference in Least Square (LS) mean of change and 95% Confidence interval were derived from pair-wise comparison within MMRM at Week 2.|Null hypothesis of change from Baseline in PANSS total score of aripiprazole IM depot 400/300mg group is same as that of placebo group was tested.||-0.2|-0.6|<.0001
72389043|NCT01663532|144286224|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6|||<|0.0001|TWO_SIDED|95.0|-0.7|-0.4||After the comparison for primary efficacy endpoint was statistically significant, the comparison of change from Baseline in CGI severity score was conducted at same alpha level 0.05.|Mixed Models Analysis|MMRM analysis with treatment, pooled centers, Week and treatment-by-Week, and Baseline-by-Week interaction as an unstructured covariate was performed.|Difference in Least Square (LS) mean of change and 95% Confidence interval were derived from pair-wise comparison within MMRM at Week 4.|Null hypothesis of change from Baseline in PANSS total score of aripiprazole IM depot 400/300mg group is same as that of placebo group was tested.||-0.4|-0.7|<.0001
72389044|NCT01663532|144286224|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7|||<|0.0001|TWO_SIDED|95.0|-0.9|-0.5||After the comparison for primary efficacy endpoint was statistically significant, the comparison of change from Baseline in CGI severity score was conducted at same alpha level 0.05.|Mixed Models Analysis|MMRM analysis with treatment, pooled centers, Week and treatment-by-Week, and Baseline-by-Week interaction as an unstructured covariate was performed.|Difference in Least Square (LS) mean of change and 95% Confidence interval were derived from pair-wise comparison within MMRM at Week 6.|Null hypothesis of change from Baseline in PANSS total score of aripiprazole IM depot 400/300mg group is same as that of placebo group was tested.||-0.5|-0.9|<.0001
72389045|NCT01663532|144286224|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7|||<|0.0001|TWO_SIDED|95.0|-0.9|-0.5||After the comparison for primary efficacy endpoint was statistically significant, the comparison of change from Baseline in CGI severity score was conducted at same alpha level 0.05.|Mixed Models Analysis|MMRM analysis with treatment, pooled centers, Week and treatment-by-Week, and Baseline-by-Week interaction as an unstructured covariate was performed.|Difference in Least Square (LS) mean of change and 95% Confidence interval were derived from pair-wise comparison within MMRM at Week 8.|Null hypothesis of change from Baseline in PANSS total score of aripiprazole IM depot 400/300mg group is same as that of placebo group was tested.||-0.5|-0.9|<.0001
72469462|NCT02633397|144462679|SUPERIORITY||Mean Difference (Final Values)|-0.14||||0.15|TWO_SIDED|90.0|-0.31|0.02|||ANCOVA|||ANCOVA model adjusted for clinic site||0.02|-0.31|0.15
72444289|NCT03526861|144402663|SUPERIORITY|The statistical test was not controlled for multiplicity.|Difference of least square means|-5.4|||<|0.001|TWO_SIDED|95.0|-7.9|-3.0||Based on the primary analysis of the primary estimand 'hypothetical'.|Repeated measurements model|||Repeated measurements model on post-baseline data. In case of no post-baseline assessments before initiation of rescue medication, the Week 2 change was imputed as 0. Data collected after permanent discontinuation of IMP or after use of rescue treatment from Week 2 to Week 16 were not included in the analysis.||-3.0|-7.9|<0.001
72444290|NCT02910713|144402709|SUPERIORITY||Least Squares Mean Difference|-13.36|STANDARD_ERROR_OF_MEAN|1.999|<|0.0001|TWO_SIDED|95.0|-17.31|-9.4||One-sided p-value for the difference between Intranasal and Extranasal.|ANOVA|||||-9.40|-17.31|<0.0001
72444291|NCT02910713|144402710|SUPERIORITY||Least Squares Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.101|<|0.0001|TWO_SIDED|95.0|-0.8|-0.4||One-sided p-value for the difference between Intranasal and Extranasal.|ANOVA|||||-0.40|-0.80|<0.0001
72444292|NCT04222660|144402734|OTHER||||||<|0.001|||||||ANOVA|||||||<0.001
72444293|NCT04222660|144402735|OTHER||||||<|0.0025|||||||t-test, 2 sided|||||||<0.0025
72444294|NCT04222660|144402736|OTHER||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
72444295|NCT04222660|144402737|OTHER||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
72444296|NCT04222660|144402738|OTHER||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
72444297|NCT04222660|144402739|OTHER||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
72444298|NCT04222660|144402740|OTHER||||||<|0.01|||||||t-test, 2 sided|||||||<0.01
72444299|NCT04222660|144402741|OTHER||||||<|0.0017|||||||t-test, 2 sided|||||||<0.0017
72444300|NCT04222660|144402742|OTHER||||||<|0.0195|||||||t-test, 2 sided|||||||<0.0195
72560252|NCT01559116|144651149|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.463|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001|TWO_SIDED|95.0|0.417|0.509|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to placebo is calculated.|||0.509|0.417|<0.0001
72560253|NCT01559116|144651149|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|0.023|<|0.0001|TWO_SIDED|95.0|0.154|0.246|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Olodaterol (5 µg) is calculated.|||0.246|0.154|<0.0001
72560254|NCT01559116|144651149|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.179|STANDARD_ERROR_OF_MEAN|0.023|<|0.0001|TWO_SIDED|95.0|0.133|0.225|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Tiotropium high dose (5 µg) is calculated.|||0.225|0.133|<0.0001
72560255|NCT01559116|144651149|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.443|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001|TWO_SIDED|95.0|0.396|0.49|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Placebo is calculated.|||0.490|0.396|<0.0001
72444301|NCT02520063|144402744|OTHER||||||||||||||||||The primary analysis was of safety and included all patients who received at least one dose of the investigational regimen. The rate of adverse events was be estimated at the end of the study along with two-sided 95% exact CIs (Clopper-Pearson intervals).|||
72444302|NCT04521478|144402758|OTHER||Mean Difference (Net)|0.7|STANDARD_ERROR_OF_MEAN|2.2||0.7636|TWO_SIDED|90.0|-3.0|4.3|||Mixed Models Analysis||Difference = (adjusted mean 5 mg BI 1358894) - (adjusted mean Placebo)|Adjusted means and confidence intervals were estimated using REML-based MMRM including the fixed categorical effects of treatment, concomitant psychotherapy use (yes vs. no), and the fixed continuous effect of baseline MADRS total score. Visit was treated as a repeated measure with an unstructured covariance matrix. The Kenward-Roger approximation was used to estimate the denominator degrees of freedom and adjust standard errors.||4.3|-3.0|0.7636
72444303|NCT04521478|144402758|OTHER||Mean Difference (Net)|2.3|STANDARD_ERROR_OF_MEAN|2.2||0.304|TWO_SIDED|90.0|-1.4|5.9|||Mixed Models Analysis||Difference = (adjusted mean 25 mg BI 1358894) - (adjusted mean Placebo)|Adjusted means and confidence intervals were estimated using REML-based MMRM including the fixed categorical effects of treatment, concomitant psychotherapy use (yes vs. no), and the fixed continuous effect of baseline MADRS total score. Visit was treated as a repeated measure with an unstructured covariance matrix. The Kenward-Roger approximation was used to estimate the denominator degrees of freedom and adjust standard errors.||5.9|-1.4|0.3040
72444304|NCT04521478|144402758|OTHER||Mean Difference (Net)|2.2|STANDARD_ERROR_OF_MEAN|2.2||0.309|TWO_SIDED|90.0|-1.4|5.7|||Mixed Models Analysis||Difference = (adjusted mean 75 mg BI 1358894) - (adjusted mean Placebo)|Adjusted means and confidence intervals were estimated using REML-based MMRM including the fixed categorical effects of treatment, concomitant psychotherapy use (yes vs. no), and the fixed continuous effect of baseline MADRS total score. Visit was treated as a repeated measure with an unstructured covariance matrix. The Kenward-Roger approximation was used to estimate the denominator degrees of freedom and adjust standard errors.||5.7|-1.4|0.3090
72444305|NCT04521478|144402758|OTHER||Mean Difference (Net)|1.5|STANDARD_ERROR_OF_MEAN|1.7||0.3694|TWO_SIDED|90.0|-1.3|4.4|||Mixed Models Analysis||Difference = (adjusted mean 125 mg BI 1358894) - (adjusted mean Placebo)|Adjusted means and confidence intervals were estimated using REML-based MMRM including the fixed categorical effects of treatment, concomitant psychotherapy use (yes vs. no), and the fixed continuous effect of baseline MADRS total score. Visit was treated as a repeated measure with an unstructured covariance matrix. The Kenward-Roger approximation was used to estimate the denominator degrees of freedom and adjust standard errors.||4.4|-1.3|0.3694
72469463|NCT02633397|144462680|SUPERIORITY||Mean Difference (Final Values)|-6.7||||0.003|TWO_SIDED|90.0|-10.28|-3.12|||ANCOVA|||ANCOVA model adjusted for clinic site||-3.12|-10.28|0.003
72469464|NCT02633397|144462681|SUPERIORITY||Mean Difference (Final Values)|3.52|||<|0.001|TWO_SIDED|90.0|2.0|5.04|||ANCOVA|||ANCOVA model adjusted for clinic site||5.04|2.00|<0.001
72469465|NCT02633397|144462682|SUPERIORITY||Mean Difference (Final Values)|286.56||||0.51|TWO_SIDED|90.0|-429.86|1002.99|||Regression, Linear|||Linear regression model adjusted for clinic site||1002.99|-429.86|0.51
72469466|NCT02633397|144462683|SUPERIORITY||Mean Difference (Final Values)|-82.18||||0.14|TWO_SIDED|90.0|-173.69|9.32|||Regression, Linear|||Linear regression model adjusted for clinic site||9.32|-173.69|0.14
72444306|NCT04521478|144402758|OTHER|||||||0.9158|||||||MCPMod Linear model|No parameter assumptions required. Corresponding dose response is linear||The Multiple Comparison Procedures and Modeling (MCPMod) procedure used the estimated values from an MMRM model as input and allowed for simultaneous evaluation of different potential dose response patterns (Linear, Exponential, Emax1, Emax2, Sigmoid Emax), while protecting the overall false positive rate (probability of Type I error) using a one-sided, nominal α level of 10 %.||||0.9158
72444307|NCT04521478|144402758|OTHER|||||||0.8676|||||||MCPMod Exponential model|Assumption: 5% of the maximum effect is achieved at 25 mg; corresponding to a drug effect achieved mainly at higher doses||The Multiple Comparison Procedures and Modeling (MCPMod) procedure used the estimated values from an MMRM model as input and allowed for simultaneous evaluation of different potential dose response patterns (Linear, Exponential, Emax1, Emax2, Sigmoid Emax), while protecting the overall false positive rate (probability of Type I error) using a one-sided, nominal α level of 10 %.||||0.8676
72469467|NCT02633397|144462684|SUPERIORITY|||||||0.78|||||||Mixed Models Analysis|||Generalized linear mixed model (logit link) with random intercept was used to compare microalbuminuria frequency as a function of time and the interaction between time and study arm.||||0.78
72560256|NCT01559116|144651149|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.181|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001|TWO_SIDED|95.0|0.134|0.227|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Olodaterol (5 µg) is calculated.|||0.227|0.134|<0.0001
72560257|NCT01559116|144651149|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.171|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001|TWO_SIDED|95.0|0.125|0.218|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Tiotropium low dose (2.5 µg) is calculated.|||0.218|0.125|<0.0001
72560258|NCT01559116|144651149|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.159|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001|TWO_SIDED|95.0|0.113|0.206|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Tiotropium high dose (5 µg) is calculated.|||0.206|0.113|<0.0001
72560259|NCT01559116|144651150|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.404|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.355|0.453|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Placebo is calculated.|||0.453|0.355|<0.0001
72560260|NCT01559116|144651150|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.219|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.17|0.267|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Olodaterol (5 µg) is calculated.|||0.267|0.170|<0.0001
72560261|NCT01559116|144651150|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.174|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.126|0.223|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Tiotropium high dose (5 µg) is calculated.|||0.223|0.126|<0.0001
72560262|NCT01559116|144651150|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.351|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.301|0.4|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Placebo is calculated.|||0.400|0.301|<0.0001
72560263|NCT01559116|144651150|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.166|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.117|0.214|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Olodaterol (5 µg) is calculated.|||0.214|0.117|<0.0001
72619192|NCT01655069|144769067|OTHER||Adjusted change from baseline|-1.8|STANDARD_ERROR_OF_MEAN|0.35|||TWO_SIDED|95.0|-2.5|-1.1|||Repeated Measures ANCOVA|Duration of solifenacin treatment: 24 weeks||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant."||-1.10|-2.50|
72560264|NCT01559116|144651150|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.148|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.099|0.197|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Tiotropium low dose (2.5 µg) is calculated.|||0.197|0.099|<0.0001
72560265|NCT01559116|144651150|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.121|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.072|0.17|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Tiotropium high dose (5 µg) is calculated.|||0.170|0.072|<0.0001
72560266|NCT01559116|144651151|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.329|STANDARD_ERROR_OF_MEAN|0.028|<|0.0001|TWO_SIDED|95.0|0.274|0.385|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Placebo is calculated.|||0.385|0.274|<0.0001
72560267|NCT01559116|144651151|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.17|STANDARD_ERROR_OF_MEAN|0.028|<|0.0001|TWO_SIDED|95.0|0.115|0.225|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Olodaterol (5 µg) is calculated.|||0.225|0.115|<0.0001
72560268|NCT01559116|144651151|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.121|STANDARD_ERROR_OF_MEAN|0.028|<|0.0001|TWO_SIDED|95.0|0.066|0.176|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Tiotropium high dose (5 µg) is calculated.|||0.176|0.066|<0.0001
72560269|NCT01559116|144651151|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.307|STANDARD_ERROR_OF_MEAN|0.029|<|0.0001|TWO_SIDED|95.0|0.251|0.363|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Placebo is calculated.|||0.363|0.251|<0.0001
72560270|NCT01559116|144651151|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.147|STANDARD_ERROR_OF_MEAN|0.028|<|0.0001|TWO_SIDED|95.0|0.092|0.203|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Olodaterol (5 µg) is calculated.|||0.203|0.092|<0.0001
72444308|NCT04521478|144402758|OTHER|||||||0.9552|||||||MCPMod Emax1 model|Assumption: 50% of the maximum effect is achieved at 25 mg; corresponding to the assumed true median effective dose (ED50) = 25 mg||The Multiple Comparison Procedures and Modeling (MCPMod) procedure used the estimated values from an MMRM model as input and allowed for simultaneous evaluation of different potential dose response patterns (Linear, Exponential, Emax1, Emax2, Sigmoid Emax), while protecting the overall false positive rate (probability of Type I error) using a one-sided, nominal α level of 10 %.||||0.9552
72560271|NCT01559116|144651151|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.166|STANDARD_ERROR_OF_MEAN|0.028|<|0.0001|TWO_SIDED|95.0|0.111|0.222|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Tiotropium low dose (2.5 µg) is calculated.|||0.222|0.111|<0.0001
72444309|NCT04521478|144402758|OTHER|||||||0.9619|||||||MCPMod Emax2 model|Assumption: 70% of the maximum effect is achieved at 5 mg; corresponding to a drug effect achieved mainly with low doses, ED50 = 2.14 mg||The Multiple Comparison Procedures and Modeling (MCPMod) procedure used the estimated values from an MMRM model as input and allowed for simultaneous evaluation of different potential dose response patterns (Linear, Exponential, Emax1, Emax2, Sigmoid Emax), while protecting the overall false positive rate (probability of Type I error) using a one-sided, nominal α level of 10 %.||||0.9619
72444310|NCT04521478|144402758|OTHER|||||||0.9507|||||||MCPMod Sigmoid Emax model|Assumption: 50% of the maximum effect is achieved at 25 mg, 90% 75 mg; corresponding to a more flexible model of the assumed true ED50 = 25 mg||The Multiple Comparison Procedures and Modeling (MCPMod) procedure used the estimated values from an MMRM model as input and allowed for simultaneous evaluation of different potential dose response patterns (Linear, Exponential, Emax1, Emax2, Sigmoid Emax), while protecting the overall false positive rate (probability of Type I error) using a one-sided, nominal α level of 10 %.||||0.9507
72444311|NCT04521478|144402759|OTHER||Odds Ratio (OR)|0.9427||||0.8889|TWO_SIDED|90.0|0.4709|1.8873|||Regression, Logistic||5 mg BI 1358894 vs Placebo|Logistic regression model, including the fixed categorical effects of treatment and baseline MDD severity.||1.8873|0.4709|0.8889
72444312|NCT04521478|144402759|OTHER||Odds Ratio (OR)|0.6581||||0.3284|TWO_SIDED|90.0|0.3255|1.3307|||Regression, Logistic||25 mg BI 1358894 vs Placebo|Logistic regression model, including the fixed categorical effects of treatment and baseline MDD severity.||1.3307|0.3255|0.3284
72444313|NCT04521478|144402759|OTHER||Odds Ratio (OR)|1.1026||||0.8048|TWO_SIDED|90.0|0.5757|2.1114|||Regression, Logistic||75 mg BI 1358894 vs Placebo|Logistic regression model, including the fixed categorical effects of treatment and baseline MDD severity.||2.1114|0.5757|0.8048
72444314|NCT04521478|144402759|OTHER||Odds Ratio (OR)|1.0072||||0.982|TWO_SIDED|90.0|0.5968|1.6999|||Regression, Logistic||125 mg BI 1358894 vs Placebo|Logistic regression model, including the fixed categorical effects of treatment and baseline MDD severity.||1.6999|0.5968|0.9820
72444315|NCT04521478|144402760|OTHER||Mean Difference (Net)|4.3|STANDARD_ERROR_OF_MEAN|2.6||0.1013|TWO_SIDED|90.0|0.0|8.6|||Mixed Models Analysis||Difference = (adjusted mean 5 mg BI 1358894) - (adjusted mean Placebo)|Adjusted means and confidence intervals were estimated using REML-based MMRM including the fixed categorical effects of treatment, concomitant psychotherapy use (yes vs. no), and the fixed continuous effect of baseline score (S-Anxiety scale). Visit was treated as a repeated measure with an unstructured covariance matrix. The Kenward-Roger approximation was used to estimate the denominator degrees of freedom and adjust standard errors.||8.6|0.0|0.1013
72469468|NCT02633397|144462685|SUPERIORITY|||||||0.3|||||||Mixed Models Analysis|||Generalized linear mixed model (logit link) with random intercept was used to compare macroalbuminuria frequency as a function of time and the interaction between time and study arm.||||0.30
72469469|NCT02633397|144462686|SUPERIORITY||Mean Difference (Final Values)|-4.91||||0.06|TWO_SIDED|90.0|-9.21|-0.62|||Mixed Models Analysis|||Linear mixed model with random intercept was used to compare the change in GFR as a function of time, the interaction between time and study arm, and clinic site.||-0.62|-9.21|0.06
72469470|NCT02633397|144462687|SUPERIORITY|||||||0.56|||||||Mixed Models Analysis|||Generalized linear mixed model (logit link) with random intercept was used to compare CKD stage frequency as a function of time and the interaction between time and study arm.||||0.56
72469471|NCT02633397|144462688|SUPERIORITY||Mean Difference (Final Values)|-0.24||||0.15|TWO_SIDED|90.0|-0.52|0.03|||Mixed Models Analysis|||Linear mixed model with random intercept was used to compare the change in hemoglobin as a function of time, the interaction between time and study arm, and clinic site.||0.03|-0.52|0.15
72469472|NCT02633397|144462689|SUPERIORITY||Mean Difference (Final Values)|1.47||||0.05|TWO_SIDED|90.0|0.22|2.72|||Mixed Models Analysis|||Linear mixed model with random intercept was used to compare the change in reticulocyte count as a function of time, the interaction between time and study arm, and clinic site.||2.72|0.22|0.05
72469473|NCT02633397|144462690|SUPERIORITY||Mean Difference (Final Values)|-0.15||||0.75|TWO_SIDED|90.0|-0.93|0.63|||Mixed Models Analysis|||Linear mixed model with random intercept was used to compare the change in WBC count as a function of time, the interaction between time and study arm, and clinic site.||0.63|-0.93|0.75
72469474|NCT02633397|144462691|SUPERIORITY||Mean Difference (Final Values)|-29.28||||0.17|TWO_SIDED|90.0|-64.63|6.08|||Mixed Models Analysis|||Linear mixed model with random intercept was used to compare the change in WBC count as a function of time, the interaction between time and study arm, and clinic site.||6.08|-64.63|0.17
72469475|NCT02633397|144462692|SUPERIORITY||Mean Difference (Final Values)|-1.64||||0.07|TWO_SIDED|90.0|-3.13|-0.15|||Regression, Linear|||Linear regression model adjusted for clinic site||-0.15|-3.13|0.07
72497248|NCT00670007|144524328|SUPERIORITY_OR_OTHER||Difference in lung density(adjusted P15)|0.294||||0.883|TWO_SIDED|95.0|-3.645|4.233||Two-sided P-value|ANCOVA|||Analysis of the percent change in lung density (for TLC + FRC combined) from baseline to 2 years was analyzed using an ANCOVA model with country, treatment, and baseline lung density as fixed effects and inspiration state as a repeated random effect.||4.233|-3.645|0.883
72497249|NCT00670007|144524328|SUPERIORITY_OR_OTHER||Difference in lung density(adjusted P15)|-0.151||||0.941|TWO_SIDED|95.0|-4.172|3.87||Two-sided P-value|ANCOVA|||Analysis of the percent change in lung density (for TLC) from baseline to 2 years was analyzed using an ANCOVA model with country, treatment, and baseline lung density as fixed effects.||3.870|-4.172|0.941
72444316|NCT04521478|144402760|OTHER||Mean Difference (Net)|2.4|STANDARD_ERROR_OF_MEAN|2.6||0.3596|TWO_SIDED|90.0|-1.9|6.6|||Mixed Models Analysis||Difference = (adjusted mean 25 mg BI 1358894) - (adjusted mean Placebo)|Adjusted means and confidence intervals were estimated using REML-based MMRM including the fixed categorical effects of treatment, concomitant psychotherapy use (yes vs. no), and the fixed continuous effect of baseline score (S-Anxiety scale). Visit was treated as a repeated measure with an unstructured covariance matrix. The Kenward-Roger approximation was used to estimate the denominator degrees of freedom and adjust standard errors.||6.6|-1.9|0.3596
72444317|NCT04521478|144402760|OTHER||Mean Difference (Net)|-1.1|STANDARD_ERROR_OF_MEAN|2.5||0.6745|TWO_SIDED|90.0|-5.2|3.1|||Mixed Models Analysis||Difference = (adjusted mean 75 mg BI 1358894) - (adjusted mean Placebo)|Adjusted means and confidence intervals were estimated using REML-based MMRM including the fixed categorical effects of treatment, concomitant psychotherapy use (yes vs. no), and the fixed continuous effect of baseline score (S-Anxiety scale). Visit was treated as a repeated measure with an unstructured covariance matrix. The Kenward-Roger approximation was used to estimate the denominator degrees of freedom and adjust standard errors.||3.1|-5.2|0.6745
72444318|NCT04521478|144402760|OTHER||Mean Difference (Net)|2.7|STANDARD_ERROR_OF_MEAN|2.0||0.187|TWO_SIDED|90.0|-0.7|6.0|||Mixed Models Analysis||Difference = (adjusted mean 125 mg BI 1358894) - (adjusted mean Placebo)|Adjusted means and confidence intervals were estimated using REML-based MMRM including the fixed categorical effects of treatment, concomitant psychotherapy use (yes vs. no), and the fixed continuous effect of baseline score (S-Anxiety scale). Visit was treated as a repeated measure with an unstructured covariance matrix. The Kenward-Roger approximation was used to estimate the denominator degrees of freedom and adjust standard errors.||6.0|-0.7|0.1870
72444319|NCT04521478|144402760|OTHER||Mean Difference (Net)|4.1|STANDARD_ERROR_OF_MEAN|2.4||0.0921|TWO_SIDED|90.0|0.1|8.1|||Mixed Models Analysis||Difference = (adjusted mean 5 mg BI 1358894) - (adjusted mean Placebo)|Adjusted means and confidence intervals were estimated using REML-based MMRM including the fixed categorical effects of treatment, concomitant psychotherapy use (yes vs. no), and the fixed continuous effect of baseline score (T-Anxiety scale). Visit was treated as a repeated measure with an unstructured covariance matrix. The Kenward-Roger approximation was used to estimate the denominator degrees of freedom and adjust standard errors.||8.1|0.1|0.0921
72444320|NCT04521478|144402760|OTHER||Mean Difference (Net)|0.8|STANDARD_ERROR_OF_MEAN|2.4||0.7395|TWO_SIDED|90.0|-3.2|4.8|||Mixed Models Analysis||Difference = (adjusted mean 25 mg BI 1358894) - (adjusted mean Placebo)|Adjusted means and confidence intervals were estimated using REML-based MMRM including the fixed categorical effects of treatment, concomitant psychotherapy use (yes vs. no), and the fixed continuous effect of baseline score (T-Anxiety scale). Visit was treated as a repeated measure with an unstructured covariance matrix. The Kenward-Roger approximation was used to estimate the denominator degrees of freedom and adjust standard errors.||4.8|-3.2|0.7395
72444321|NCT04521478|144402760|OTHER||Mean Difference (Net)|1.1|STANDARD_ERROR_OF_MEAN|2.4||0.6296|TWO_SIDED|90.0|-2.7|5.0|||Mixed Models Analysis||Difference = (adjusted mean 75 mg BI 1358894) - (adjusted mean Placebo)|Adjusted means and confidence intervals were estimated using REML-based MMRM including the fixed categorical effects of treatment, concomitant psychotherapy use (yes vs. no), and the fixed continuous effect of baseline score (T-Anxiety scale). Visit was treated as a repeated measure with an unstructured covariance matrix. The Kenward-Roger approximation was used to estimate the denominator degrees of freedom and adjust standard errors.||5.0|-2.7|0.6296
72444322|NCT04521478|144402760|OTHER||Mean Difference (Net)|3.8|STANDARD_ERROR_OF_MEAN|1.9||0.0429|TWO_SIDED|90.0|0.7|6.9|||Mixed Models Analysis||Difference = (adjusted mean 125 mg BI 1358894) - (adjusted mean Placebo)|Adjusted means and confidence intervals were estimated using REML-based MMRM including the fixed categorical effects of treatment, concomitant psychotherapy use (yes vs. no), and the fixed continuous effect of baseline score (T-Anxiety scale). Visit was treated as a repeated measure with an unstructured covariance matrix. The Kenward-Roger approximation was used to estimate the denominator degrees of freedom and adjust standard errors.||6.9|0.7|0.0429
72497250|NCT00670007|144524328|SUPERIORITY_OR_OTHER||Difference in lung density(adjusted P15)|1.787||||0.404|TWO_SIDED|95.0|-2.44|6.014||Two-sided P-value|ANCOVA|||Analysis of the percent change in lung density (for FRC) from baseline to 2 years was analyzed using an ANCOVA model with country, treatment, and baseline lung density as fixed effects.||6.014|-2.440|0.404
72497251|NCT00618722|144524338|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4||||0.043|TWO_SIDED|95.0|-0.9|0.0|||ANCOVA|Based on analysis of covariance (ANCOVA) model with treatment as fixed effect and baseline SMF rating as covariate.||||0.0|-0.9|0.043
72497252|NCT00618722|144524338|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4||||0.05|TWO_SIDED|95.0|-0.8|0.0|||ANCOVA|Based on analysis of covariance (ANCOVA) model with treatment as fixed effect and baseline SMF rating as covariate.||||0.0|-0.8|0.050
72497253|NCT00618722|144524338|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2||||0.249|TWO_SIDED|95.0|-0.7|0.2|||ANCOVA|Based on analysis of covariance (ANCOVA) model with treatment as fixed effect and baseline SMF rating as covariate.||||0.2|-0.7|0.249
72560272|NCT01559116|144651151|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.099|STANDARD_ERROR_OF_MEAN|0.028|<|0.0001|TWO_SIDED|95.0|0.043|0.154|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Tiotropium high dose (5 µg) is calculated.|||0.154|0.043|<0.0001
72497254|NCT00618722|144524339|SUPERIORITY_OR_OTHER||LS Mean Difference|1.9||||0.003|TWO_SIDED|95.0|0.7|3.1|||ANCOVA|Based on analysis of covariance (ANCOVA) model with treatment as fixed effect and baseline SMF rating as covariate.||||3.1|0.7|0.003
72389046|NCT01663532|144286224|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8|||<|0.0001|TWO_SIDED|95.0|-1.1|-0.6||After the comparison for primary efficacy endpoint was statistically significant, the comparison of change from Baseline in CGI severity score was conducted at same alpha level 0.05.|Mixed Models Analysis|MMRM analysis with treatment, pooled centers, Week and treatment-by-Week, and Baseline-by-Week interaction as an unstructured covariate was performed.|Difference in Least Square (LS) mean of change and 95% Confidence interval were derived from pair-wise comparison within MMRM at Week 10.|Null hypothesis of change from Baseline in PANSS total score of aripiprazole IM depot 400/300mg group is same as that of placebo group was tested.||-0.6|-1.1|<.0001
72389047|NCT01663532|144286225|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.4||||0.0006|TWO_SIDED|95.0|-2.1|-0.6|||Mixed Models Analysis|MMRM analysis with treatment, pooled centers, Week and treatment-by-Week, and Baseline-by-Week interaction as an unstructured covariate was performed.|Difference in Least Square (LS) mean of change and 95% Confidence interval were derived from pair-wise comparison within MMRM at Week 1.|Null hypothesis of change from Baseline in PANSS total score of aripiprazole IM depot 400/300mg group is same as that of placebo group was tested.||-0.6|-2.1|0.0006
72389048|NCT01663532|144286225|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.3|||<|0.0001|TWO_SIDED|95.0|-3.3|-1.3|||Mixed Models Analysis|MMRM analysis with treatment, pooled centers, Week and treatment-by-Week, and Baseline-by-Week interaction as an unstructured covariate was performed.|Difference in Least Square (LS) mean of change and 95% Confidence interval were derived from pair-wise comparison within MMRM at Week 2.|Null hypothesis of change from Baseline in PANSS total score of aripiprazole IM depot 400/300mg group is same as that of placebo group was tested.||-1.3|-3.3|<.0001
72389049|NCT01663532|144286225|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.1|||<|0.0001|TWO_SIDED|95.0|-4.3|-2.0|||Mixed Models Analysis|MMRM analysis with treatment, pooled centers, Week and treatment-by-Week, and Baseline-by-Week interaction as an unstructured covariate was performed.|Difference in Least Square (LS) mean of change and 95% Confidence interval were derived from pair-wise comparison within MMRM at Week 4.|Null hypothesis of change from Baseline in PANSS total score of aripiprazole IM depot 400/300mg group is same as that of placebo group was tested.||-2.0|-4.3|<.0001
72389050|NCT01663532|144286225|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.8|||<|0.0001|TWO_SIDED|95.0|-5.1|-2.6|||Mixed Models Analysis|MMRM analysis with treatment, pooled centers, Week and treatment-by-Week, and Baseline-by-Week interaction as an unstructured covariate was performed.|Difference in Least Square (LS) mean of change and 95% Confidence interval were derived from pair-wise comparison within MMRM at Week 6.|Null hypothesis of change from Baseline in PANSS total score of aripiprazole IM depot 400/300mg group is same as that of placebo group was tested.||-2.6|-5.1|<.0001
72389051|NCT01663532|144286225|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.8|||<|0.0001|TWO_SIDED|95.0|-6.2|-3.4|||Mixed Models Analysis|MMRM analysis with treatment, pooled centers, Week and treatment-by-Week, and Baseline-by-Week interaction as an unstructured covariate was performed.|Difference in Least Square (LS) mean of change and 95% Confidence interval were derived from pair-wise comparison within MMRM at Week 8.|Null hypothesis of change from Baseline in PANSS total score of aripiprazole IM depot 400/300mg group is same as that of placebo group was tested.||-3.4|-6.2|<.0001
72389052|NCT01663532|144286225|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.1|||<|0.0001|TWO_SIDED|95.0|-6.4|-3.7|||Mixed Models Analysis|MMRM analysis with treatment, pooled centers, Week and treatment-by-Week, and Baseline-by-Week interaction as an unstructured covariate was performed.|Difference in Least Square (LS) mean of change and 95% Confidence interval were derived from pair-wise comparison within MMRM at Week 10.|Null hypothesis of change from Baseline in PANSS total score of aripiprazole IM depot 400/300mg group is same as that of placebo group was tested.||-3.7|-6.4|<.0001
72389053|NCT01663532|144286226|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9||||0.0023|TWO_SIDED|95.0|-1.6|-0.3|||Mixed Models Analysis|MMRM analysis with treatment, pooled centers, Week and treatment-by-Week, and Baseline-by-Week interaction as an unstructured covariate was performed.|Difference in Least Square (LS) mean of change and 95% Confidence interval were derived from pair-wise comparison within MMRM at Week 1.|Null hypothesis of change from Baseline in PANSS total score of aripiprazole IM depot 400/300mg group is same as that of placebo group was tested.||-0.3|-1.6|0.0023
72389054|NCT01663532|144286226|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.2||||0.0032|TWO_SIDED|95.0|-2.0|-0.4|||Mixed Models Analysis|MMRM analysis with treatment, pooled centers, Week and treatment-by-Week, and Baseline-by-Week interaction as an unstructured covariate was performed.|Difference in Least Square (LS) mean of change and 95% Confidence interval were derived from pair-wise comparison within MMRM at Week 2.|Null hypothesis of change from Baseline in PANSS total score of aripiprazole IM depot 400/300mg group is same as that of placebo group was tested.||-0.4|-2.0|0.0032
72389055|NCT01663532|144286226|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.8||||0.0003|TWO_SIDED|95.0|-2.7|-0.8|||Mixed Models Analysis|MMRM analysis with treatment, pooled centers, Week and treatment-by-Week, and Baseline-by-Week interaction as an unstructured covariate was performed.|Difference in Least Square (LS) mean of change and 95% Confidence interval were derived from pair-wise comparison within MMRM at Week 4.|Null hypothesis of change from Baseline in PANSS total score of aripiprazole IM depot 400/300mg group is same as that of placebo group was tested.||-0.8|-2.7|0.0003
72389056|NCT01663532|144286226|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.2|||<|0.0001|TWO_SIDED|95.0|-3.2|-1.3|||Mixed Models Analysis|MMRM analysis with treatment, pooled centers, Week and treatment-by-Week, and Baseline-by-Week interaction as an unstructured covariate was performed.|Difference in Least Square (LS) mean of change and 95% Confidence interval were derived from pair-wise comparison within MMRM at Week 6.|Null hypothesis of change from Baseline in PANSS total score of aripiprazole IM depot 400/300mg group is same as that of placebo group was tested.||-1.3|-3.2|<.0001
72497255|NCT00618722|144524339|SUPERIORITY_OR_OTHER||LS Mean Difference|1.4||||0.03|TWO_SIDED|95.0|0.1|2.6|||ANCOVA|Based on analysis of covariance (ANCOVA) model with treatment as fixed effect and baseline SMF rating as covariate.||||2.6|0.1|0.030
72497256|NCT00618722|144524339|SUPERIORITY_OR_OTHER||LS Mean Difference|1.6||||0.012|TWO_SIDED|95.0|0.4|2.8|||ANCOVA|Based on analysis of covariance (ANCOVA) model with treatment as fixed effect and baseline SMF rating as covariate.||||2.8|0.4|0.012
72444323|NCT04521478|144402761|OTHER||Mean Difference (Net)|0.1|STANDARD_ERROR_OF_MEAN|0.3||0.6211|TWO_SIDED|90.0|-0.3|0.5|||Mixed Models Analysis||Difference = (adjusted mean 5 mg BI 1358894) - (adjusted mean Placebo)|Adjusted means and confidence intervals were estimated using REML-based MMRM including the fixed categorical effects of treatment, concomitant psychotherapy use (yes vs. no), and the fixed continuous effect of the baseline score. Visit was treated as a repeated measure with an unstructured covariance matrix. The Kenward-Roger approximation was used to estimate the denominator degrees of freedom and adjust standard errors.||0.5|-0.3|0.6211
72444324|NCT04521478|144402761|OTHER||Mean Difference (Net)|0.2|STANDARD_ERROR_OF_MEAN|0.2||0.5158|TWO_SIDED|90.0|-0.2|0.6|||Mixed Models Analysis||Difference = (adjusted mean 25 mg BI 1358894) - (adjusted mean Placebo)|Adjusted means and confidence intervals were estimated using REML-based MMRM including the fixed categorical effects of treatment, concomitant psychotherapy use (yes vs. no), and the fixed continuous effect of the baseline score. Visit was treated as a repeated measure with an unstructured covariance matrix. The Kenward-Roger approximation was used to estimate the denominator degrees of freedom and adjust standard errors.||0.6|-0.2|0.5158
72444325|NCT04521478|144402761|OTHER||Mean Difference (Net)|0.2|STANDARD_ERROR_OF_MEAN|0.2||0.4518|TWO_SIDED|90.0|-0.2|0.6|||Mixed Models Analysis||Difference = (adjusted mean 75 mg BI 1358894) - (adjusted mean Placebo)|Adjusted means and confidence intervals were estimated using REML-based MMRM including the fixed categorical effects of treatment, concomitant psychotherapy use (yes vs. no), and the fixed continuous effect of the baseline score. Visit was treated as a repeated measure with an unstructured covariance matrix. The Kenward-Roger approximation was used to estimate the denominator degrees of freedom and adjust standard errors.||0.6|-0.2|0.4518
72560273|NCT01559116|144651152|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.462|STANDARD_ERROR_OF_MEAN|0.028|<|0.0001|TWO_SIDED|95.0|0.408|0.516|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Placebo is calculated.|||0.516|0.408|<0.0001
72444326|NCT04521478|144402761|OTHER||Mean Difference (Net)|0.2|STANDARD_ERROR_OF_MEAN|0.2||0.2347|TWO_SIDED|90.0|-0.1|0.6|||Mixed Models Analysis||Difference = (adjusted mean 125 mg BI 1358894) - (adjusted mean Placebo)|Adjusted means and confidence intervals were estimated using REML-based MMRM including the fixed categorical effects of treatment, concomitant psychotherapy use (yes vs. no), and the fixed continuous effect of the baseline score. Visit was treated as a repeated measure with an unstructured covariance matrix. The Kenward-Roger approximation was used to estimate the denominator degrees of freedom and adjust standard errors.||0.6|-0.1|0.2347
72560274|NCT01559116|144651152|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.159|STANDARD_ERROR_OF_MEAN|0.027|<|0.0001|TWO_SIDED|95.0|0.105|0.212|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Olodaterol (5 µg) is calculated.|||0.212|0.105|<0.0001
72560275|NCT01559116|144651152|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.151|STANDARD_ERROR_OF_MEAN|0.027|<|0.0001|TWO_SIDED|95.0|0.098|0.205|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Tiotropium high dose (5 µg) is calculated.|||0.205|0.098|<0.0001
72619193|NCT01655069|144769067|OTHER||Adjusted change from baseline|-1.57|STANDARD_ERROR_OF_MEAN|0.36|||TWO_SIDED|95.0|-2.29|-0.85|||Repeated Measures ANCOVA|Duration of solifenacin treatment: 40 weeks||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant."||-0.85|-2.29|
72444327|NCT04521478|144402762|OTHER||Mean Difference (Net)|3.4|STANDARD_ERROR_OF_MEAN|2.5||0.1723|TWO_SIDED|90.0|-0.7|7.6|||Mixed Models Analysis||Difference = (adjusted mean 5 mg BI 1358894) - (adjusted mean Placebo)|Adjusted means and confidence intervals were estimated using REML-based MMRM including the fixed categorical effects of treatment, concomitant psychotherapy use (yes vs. no), and the fixed continuous effect of the baseline score. Visit was treated as a repeated measure with an unstructured covariance matrix. The Kenward-Roger approximation was used to estimate the denominator degrees of freedom and adjust standard errors.||7.6|-0.7|0.1723
72444328|NCT04521478|144402762|OTHER||Mean Difference (Net)|4.4|STANDARD_ERROR_OF_MEAN|2.5||0.0757|TWO_SIDED|90.0|0.3|8.5|||Mixed Models Analysis||Difference = (adjusted mean 25 mg BI 1358894) - (adjusted mean Placebo)|Adjusted means and confidence intervals were estimated using REML-based MMRM including the fixed categorical effects of treatment, concomitant psychotherapy use (yes vs. no), and the fixed continuous effect of the baseline score. Visit was treated as a repeated measure with an unstructured covariance matrix. The Kenward-Roger approximation was used to estimate the denominator degrees of freedom and adjust standard errors.||8.5|0.3|0.0757
72444329|NCT04521478|144402762|OTHER||Mean Difference (Net)|1.0|STANDARD_ERROR_OF_MEAN|2.4||0.6864|TWO_SIDED|90.0|-3.0|5.0|||Mixed Models Analysis||Difference = (adjusted mean 75 mg BI 1358894) - (adjusted mean Placebo)|Adjusted means and confidence intervals were estimated using REML-based MMRM including the fixed categorical effects of treatment, concomitant psychotherapy use (yes vs. no), and the fixed continuous effect of the baseline score. Visit was treated as a repeated measure with an unstructured covariance matrix. The Kenward-Roger approximation was used to estimate the denominator degrees of freedom and adjust standard errors.||5.0|-3.0|0.6864
72444330|NCT04521478|144402762|OTHER||Mean Difference (Net)|2.8|STANDARD_ERROR_OF_MEAN|1.9||0.1585|TWO_SIDED|90.0|-0.5|6.0|||Mixed Models Analysis||Difference = (adjusted mean 125 mg BI 1358894) - (adjusted mean Placebo)|Adjusted means and confidence intervals were estimated using REML-based MMRM including the fixed categorical effects of treatment, concomitant psychotherapy use (yes vs. no), and the fixed continuous effect of the baseline score. Visit was treated as a repeated measure with an unstructured covariance matrix. The Kenward-Roger approximation was used to estimate the denominator degrees of freedom and adjust standard errors.||6.0|-0.5|0.1585
72497257|NCT00618722|144524340|SUPERIORITY_OR_OTHER||Difference from Placebo|38.9||||0.015|TWO_SIDED|95.0|12.6|65.2|||Fisher Exact|||||65.2|12.6|0.015
72560276|NCT01559116|144651152|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.452|STANDARD_ERROR_OF_MEAN|0.028|<|0.0001|TWO_SIDED|95.0|0.398|0.507|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Placebo is calculated.|||0.507|0.398|<0.0001
72444331|NCT01757665|144402832|SUPERIORITY||percent of patients|0.1|||||ONE_SIDED|95.0||0.7|||||Upper 95% CI was calculated by the method of Clopper and Pearson, using the Beta distribution with parameters x + 1 and n - x where x is the number of SVD events by POD 390 and n is the number of subjects followed at the 1 year assessment.|The null hypothesis is that the rate of structural valve deterioration at one year is greater than 1%. The alternative hypothesis is that this rate is less than 1%.||0.7||
72444332|NCT02379156|144402885|SUPERIORITY||||||<|0.001|||||||ANOVA|||Between-group differences in the change in core body temperature (Tcore) from baseline (BL) values to after cold exposure (Cold) were analyzed using a Mixed Model ANOVA. We hypothesized that participants with tetraplegia would have a greater decrease in Tcore when exposed to cool ambient temperature than control participants exposed to the same cool ambient temperature.||||<0.001
72444333|NCT02379156|144402885|SUPERIORITY|||||||0.006|||||||ANOVA|||Within-group differences in the change in (Tcore) in the participants with tetraplegia from BL values to Cold, with and without a dose of 10 mg of midodrine (two separate visits), were analyzed using a Repeated Measures ANOVA .||||0.006
72444334|NCT02379156|144402886|SUPERIORITY|||||||0.042|||||||t-test, 2 sided|||Between-group differences in the percent change in total WAIS IV scores from BL to after cold ambient exposure were analyzed using an independent samples T-test. We hypothesized that participants with tetraplegia would have a greater percent change in total WAIS IV scores due to impaired cognitive function post cool ambient exposure.||||.042
72444335|NCT02379156|144402886|SUPERIORITY|||||||0.149|||||||t-test, 2 sided|||"Within-group differences in the percent change in total WAIS IV scores from BL to after cold ambient exposure were analyzed using a paired samples t-test. We hypothesized that participants with tetraplegia in the No Drug condition would have a greater percent change in total WAIS IV scores than the same participants in the With drug condition."||||0.149
72444336|NCT02379156|144402887|SUPERIORITY||||||<|0.001|||||||ANOVA|||Between-group differences in the change in distal skin temperature temperature (Tsk) from baseline (BL) values to after ambient cold exposure (Cold) were analyzed using a mixed-model ANOVA for the AB vs Tetra comparison. We hypothesized that participants with tetraplegia would have a smaller change in Tsk due to being in a constant state of vasodilation.||||<0.001
72444337|NCT02379156|144402887|SUPERIORITY||||||<|0.001|||||||ANOVA|||Within-group differences in the change in distal skin temperature temperature (Tsk) from baseline (BL) values to after ambient cold exposure (Cold) were analyzed using a repeated measures ANOVA for the within-group comparison of drug vs no drug in the tetraplegia group. We hypothesized that participants with tetraplegia with drug would have a larger decrease in Tsk due to enhanced peripheral vasoconstriction due to the drug's effects.||||<.001
72444338|NCT02379156|144402888|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||Between-group differences in the percent change in microvascular perfusion from baseline to after cool ambient exposure were analyzed using independent samples T-test. We hypothesized that participants with tetraplegia would have a smaller percent change in microvascular perfusion due impaired vasomotor control which causes a constant state of vasodilation.||||<0.001
72444339|NCT02379156|144402888|SUPERIORITY|||||||0.066|||||||t-test, 2 sided|||"Within-group differences in the percent change in microvascular perfusion from baseline to after cool ambient exposure were analyzed using a paired samples t-test. We hypothesized that participants with tetraplegia in the No Drug condition would have a smaller percent change in microvascular perfusion due impaired vasomotor control which causes a constant state of vasodilation."||||0.066
72444340|NCT02379156|144402889|SUPERIORITY|||||||0.127|||||||t-test, 2 sided|||Between-group differences in the percent change in VO2 from baseline to after cool ambient exposure were analyzed using independent samples t-test. We hypothesized that participants with tetraplegia would have a smaller percent change in VO2 consumption.||||0.127
72444341|NCT02379156|144402889|SUPERIORITY|||||||0.964|||||||t-test, 2 sided|||"Within-group differences in the percent change in VO2 consumption from baseline to after cool ambient exposure were analyzed using a paired samples t-test. We hypothesized that participants with tetraplegia in the No Drug condition would have a greater percent change in VO2 consumption due to impaired vasoconstriction and greater heat loss compared to the With Drug condition, in response to cool ambient exposure."||||0.964
72444342|NCT04549168|144402922|SUPERIORITY||LS geometric mean ratio|0.795||||0.0585|TWO_SIDED|95.0|0.627|1.008||Data was analyzed using mixed effect model repeated measurement analysis (MMRM), and the missing values were imputed using multiple imputation and assumed to be missing not at random (MNAR).|MMRM|||||1.008|0.627|0.0585
72444343|NCT04549168|144402923|SUPERIORITY||LSM difference|7.1|||<|0.0001|TWO_SIDED|95.0|4.39|9.81||Data was analyzed using MMRM, and the missing values were imputed using multiple imputation and assumed to be MNAR.|MMRM|||||9.81|4.39|<0.0001
72444344|NCT04549168|144402924|SUPERIORITY||LSM difference|-17.84||||0.0002|TWO_SIDED|95.0|-27.16|-8.51||Data was analyzed using MMRM, and the missing values were imputed using multiple imputation and assumed to be MNAR.|MMRM|||||-8.51|-27.16|0.0002
72444345|NCT04549168|144402925|SUPERIORITY||LS geometric mean ratio|0.776||||0.0063|TWO_SIDED|95.0|0.647|0.93||Data was analyzed using MMRM, and the missing values were imputed using multiple imputation and assumed to be MNAR.|MMRM|||||0.930|0.647|0.0063
72444346|NCT04549168|144402926|SUPERIORITY||LSM difference|4.49||||0.0242|TWO_SIDED|95.0|0.59|8.39||Data was analyzed using MMRM, and the missing values were imputed using multiple imputation and assumed to be MNAR.|MMRM|||||8.39|0.59|0.0242
72444347|NCT04549168|144402927|SUPERIORITY||LSM difference|-10.36||||0.1625|TWO_SIDED|95.0|-24.95|4.22||Data was analyzed using MMRM, and the missing values were imputed using multiple imputation and assumed to be MNAR.|MMRM|||||4.22|-24.95|0.1625
72444348|NCT04549168|144402928|SUPERIORITY||LS geometric mean ratio|0.815||||0.0515|TWO_SIDED|95.0|0.663|1.001||Data was analyzed using MMRM, and the missing values were imputed using multiple imputation and assumed to be MNAR.|MMRM|||||1.001|0.663|0.0515
72444349|NCT04549168|144402929|SUPERIORITY||LSM difference|7.74|||<|0.0001|TWO_SIDED|95.0|5.61|9.86||Data was analyzed using MMRM, and the missing values were imputed using multiple imputation and assumed to be MNAR.|MMRM|||||9.86|5.61|<0.0001
72444350|NCT04549168|144402930|SUPERIORITY||LSM difference|-21.25|||<|0.0001|TWO_SIDED|95.0|-28.15|-14.35||Data was analyzed using MMRM, and the missing values were imputed using multiple imputation and assumed to be MNAR.|MMRM|||||-14.35|-28.15|<0.0001
72444351|NCT04549168|144402932|SUPERIORITY||LSM difference|-2.85|STANDARD_ERROR_OF_MEAN|0.811||0.0006|TWO_SIDED|95.0|-4.45|-1.25||Based on Analysis of Covariance (ANCOVA) model with factors of age group, site, treatment, and the baseline ISI as a covariate.|ANCOVA|||||-1.25|-4.45|0.0006
72444352|NCT04549168|144402933|SUPERIORITY||LSM difference|-1.74|STANDARD_ERROR_OF_MEAN|0.488||0.0005|TWO_SIDED|95.0|-2.7|-0.78||Based on ANCOVA model with factors of age group, site, treatment, and the baseline ISI as a covariate.|ANCOVA|||||-0.78|-2.70|0.0005
72560277|NCT01559116|144651152|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.149|STANDARD_ERROR_OF_MEAN|0.028|<|0.0001|TWO_SIDED|95.0|0.095|0.203|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Olodaterol (5 µg) is calculated.|||0.203|0.095|<0.0001
72560278|NCT01559116|144651152|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.161|STANDARD_ERROR_OF_MEAN|0.028|<|0.0001|TWO_SIDED|95.0|0.107|0.216|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Tiotropium low dose (2.5 µg) is calculated.|||0.216|0.107|<0.0001
72560279|NCT01559116|144651152|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.142|STANDARD_ERROR_OF_MEAN|0.028|<|0.0001|TWO_SIDED|95.0|0.087|0.196|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Tiotropium high dose (5 µg) is calculated.|||0.196|0.087|<0.0001
72560280|NCT04610580|144651153|OTHER||Geometric Least Square Mean Ratio (%)|95.0|||||TWO_SIDED|90.0|82.1|110.0||||||The formulation impact (12 × 1.25 mg EC mini-tablet versus 1 × 15 mg EC tablet) on plasma total Mo PK parameters was assessed using analysis of variance (ANOVA) statistical model with dosing period, treatment, and treatment sequence as the fixed effects and the participant (sequence) as a random effect, using the natural logarithms of the data.||110.0|82.1|
72560281|NCT04610580|144651154|OTHER||Geometric Least Square Mean Ratio (%)|96.243|||||TWO_SIDED|90.0|86.384|107.227||||||The formulation impact (12 × 1.25 mg EC mini-tablet versus 1 × 15 mg EC tablet) on plasma total Mo PK parameters was assessed using ANOVA statistical model with dosing period, treatment, and treatment sequence as the fixed effects and the participant (sequence) as a random effect, using the natural logarithms of the data.||107.227|86.384|
72560282|NCT04610580|144651155|OTHER||Geometric Least Square Mean Ratio (%)|94.9|||||TWO_SIDED|90.0|81.6|110.5||||||The formulation impact (12 × 1.25 mg EC mini-tablet versus 1 × 15 mg EC tablet) on plasma total Mo PK parameters was assessed using ANOVA statistical model with dosing period, treatment, and treatment sequence as the fixed effects and the participant (sequence) as a random effect, using the natural logarithms of the data.||110.5|81.6|
72560283|NCT04610580|144651156|OTHER||Geometric Least Square Mean Ratio (%)|101.2|||||TWO_SIDED|90.0|70.6|145.1||||||The formulation impact (12 × 1.25 mg EC mini-tablet versus 1 × 15 mg EC tablet) on plasma total Mo PK parameters was assessed using ANOVA statistical model with dosing period, treatment, and treatment sequence as the fixed effects and the participant (sequence) as a random effect, using the natural logarithms of the data.||145.1|70.6|
72444353|NCT04549168|144402935|SUPERIORITY||LSM difference|0.34||||0.0312|TWO_SIDED|95.0|0.03|0.65||Data was analyzed using MMRM, and the missing values were imputed using multiple imputation and assumed to be MNAR.|MMRM||First 7 mornings of treatment period|||0.65|0.03|0.0312
72560284|NCT04610580|144651157|OTHER||Geometric Least Square Mean Ratio (%)|99.1|||||TWO_SIDED|90.0|89.3|109.9||||||The formulation impact (12 × 1.25 mg EC mini-tablet versus 1 × 15 mg EC tablet) on plasma total Mo PK parameters was assessed using ANOVA statistical model with dosing period, treatment, and treatment sequence as the fixed effects and the participant (sequence) as a random effect, using the natural logarithms of the data.||109.9|89.3|
72560285|NCT01097694|144651163|SUPERIORITY||||||<|0.05|||||||Mixed Models Analysis|||"Our null hypothesis was that the mean of this ratio will be 0 after log2-transformed.~The target enrollment was 60 assuming 10% drop-out for 54 completions which gave us 80% power to detect a doubling-dose change in PC20."||||<0.05
72560286|NCT01097694|144651164|SUPERIORITY||||||<|0.05|||||||Regression, Linear|Adjusted for baseline.||||||<0.05
72560287|NCT01097694|144651165|SUPERIORITY|||||||0.12|||||||Regression, Linear|Adjusted for baseline.||||||0.12
72560288|NCT01097694|144651166|SUPERIORITY|||||||0.1|||||||Regression, Linear|Adjusted for baseline.||||||0.10
72560289|NCT01097694|144651167|SUPERIORITY|||||||0.36|||||||Poisson regression model|||||||0.36
72444354|NCT04549168|144402935|SUPERIORITY||LSM difference|0.32||||0.146|TWO_SIDED|95.0|-0.11|0.76||Data was analyzed using MMRM, and the missing values were imputed using multiple imputation and assumed to be MNAR.|MMRM||Last 7 mornings of treatment period|||0.76|-0.11|0.1460
72444355|NCT04549168|144402935|SUPERIORITY||LSM difference|0.29||||0.1613|TWO_SIDED|95.0|-0.12|0.7||Data was analyzed using MMRM, and the missing values were imputed using multiple imputation and assumed to be MNAR.|MMRM||First 7 mornings of follow-up period|||0.70|-0.12|0.1613
72444356|NCT04549168|144402935|SUPERIORITY||LSM difference|0.23||||0.2852|TWO_SIDED|95.0|-0.19|0.65||Data was analyzed using MMRM, and the missing values were imputed using multiple imputation and assumed to be MNAR.|MMRM||Last 7 mornings of follow-up period|||0.65|-0.19|0.2852
72444357|NCT02662062|144402965|OTHER|This is a single arm study looking at a binary value with the hypothesis suggesting it falls within a certain range.||||||||||||||||The null hypothesis is that the addition of pembrolizumab to chemoradiation is not unsafe (percentage of the population experiencing unacceptable toxicity is not \>50%)|A Clopper-Pearson method was used to determine the unacceptable toxicity rate and a 95% confidence interval for this binary outcome measure.|||
72444358|NCT02662062|144402966|OTHER|Single arm study with no comparator arm and assessment of a binary variable. Clopper-Pearson method used to calculate the 95% confidence interval relating to this proportion.|||||||||||||||||Single arm study with no comparator arm and assessment of a binary variable. Clopper-Pearson method used to calculate the 95% confidence interval relating to this proportion.|||
72497258|NCT00618722|144524340|SUPERIORITY_OR_OTHER||Difference from Placebo|28.9||||0.096|TWO_SIDED|95.0|0.4|57.5|||Fisher Exact|||||57.5|0.4|0.096
72444359|NCT02662062|144402967|OTHER|Single arm study with no comparator arm and assessment of a binary variable. Clopper-Pearson method used to calculate the 95% confidence interval relating to this proportion.|||||||||||||||||Single arm study with no comparator arm and assessment of a binary variable. Clopper-Pearson method used to calculate the 95% confidence interval relating to this proportion.|||
72444360|NCT02662062|144402968|OTHER|Non comparative trial with a single arm|Kaplan Meier Estimate|39.0|||||TWO_SIDED|95.0|17.0||missing upper limit of 95% confidence interval on the survival estimate from Kaplan-Meier estimator due to small number events||||||||17|
72444361|NCT02662062|144402969|OTHER|Kaplan Meier Estimate performed for a 12 month timepoint in a single arm non comparative study|Kaplan Meier Estimate|92.0|||||TWO_SIDED|95.0|72.0|98.0||||||||98|72|
72497259|NCT00618722|144524340|SUPERIORITY_OR_OTHER||Difference from Placebo|44.7||||0.003|TWO_SIDED|95.0|20.6|68.8|||Fisher Exact|||||68.8|20.6|0.003
72497260|NCT00618722|144524341|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3||||0.078|TWO_SIDED|95.0|0.0|0.6|||Repeated measures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 4||0.6|0.0|0.078
72497261|NCT00618722|144524341|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0||||0.781|TWO_SIDED|95.0|-0.3|0.4|||Repeated easures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 4||0.4|-0.3|0.781
72497262|NCT00618722|144524341|SUPERIORITY_OR_OTHER||LS Mean Difference|0.2||||0.146|TWO_SIDED|95.0|-0.1|0.5|||Repeated measures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 4||0.5|-0.1|0.146
72497263|NCT00618722|144524341|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3||||0.076|TWO_SIDED|95.0|0.0|0.6|||Repeated measures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 8||0.6|0.0|0.076
72497264|NCT00618722|144524341|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0||||0.975|TWO_SIDED|95.0|-0.3|0.3|||Repeated measures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 8||0.3|-0.3|0.975
72497265|NCT00618722|144524341|SUPERIORITY_OR_OTHER||LS Mean Difference|0.2||||0.183|TWO_SIDED|95.0|-0.1|0.5|||Repeated measures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 8||0.5|-0.1|0.183
72497266|NCT00618722|144524341|SUPERIORITY_OR_OTHER||LS Mean Difference|0.4||||0.017|TWO_SIDED|95.0|0.1|0.7|||Repeated measures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 12||0.7|0.1|0.017
72497267|NCT00618722|144524341|SUPERIORITY_OR_OTHER||LS Mean Difference|0.4||||0.022|TWO_SIDED|95.0|0.1|0.7|||Repeated measures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 12||0.7|0.1|0.022
72497268|NCT00618722|144524341|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3||||0.081|TWO_SIDED|95.0|0.0|0.6|||Repeated measures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 12||0.6|0.0|0.081
72497269|NCT00618722|144524341|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1||||0.51|TWO_SIDED|95.0|-0.2|0.4|||Repeated measures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 16||0.4|-0.2|0.510
72497270|NCT00618722|144524341|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2||||0.33|TWO_SIDED|95.0|-0.5|0.2|||Repeated measures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 16||0.2|-0.5|0.330
72497271|NCT00618722|144524341|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1||||0.72|TWO_SIDED|95.0|-0.3|0.4|||Repeated Measures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 16||0.4|-0.3|0.720
72497272|NCT00618722|144524341|SUPERIORITY_OR_OTHER||LS Mean Difference|0.2||||0.205|TWO_SIDED|95.0|-0.1|0.5|||Repeated measures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 24||0.5|-0.1|0.205
72497273|NCT00618722|144524341|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1||||0.41|TWO_SIDED|95.0|-0.5|0.2|||Repeated measures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 24||0.2|-0.5|0.410
72444362|NCT02662062|144402970|OTHER|Kaplan Meier Estimate of single arm non comparative study|Kaplan Meier Estimate|85.0|||||TWO_SIDED|95.0|64.0|94.0||||||||94|64|
72444363|NCT02662062|144402971|OTHER|Kaplan Meier estimate at a 12 month timepoint for a single arm non comparative study|Kaplan Meier Estimate|88.0|||||TWO_SIDED|95.0|68.0|98.0||||||||98|68|
72444364|NCT06311084|144402979|OTHER|We used Wilcoxon Signed-Rank Test for our non-normally distributed data to compare scores before and after the Imaginator intervention.||||||0.05|||||||Wilcoxon (Mann-Whitney)|||||||0.05
72444365|NCT06311084|144402980|OTHER|We used Wilcoxon Signed-Rank Test for our non-normally distributed data to compare scores before and after the Imaginator intervention.||||||0.05|||||||Wilcoxon (Mann-Whitney)|||||||0.05
72444366|NCT06311084|144402981|OTHER|We used Wilcoxon Signed-Rank Test for our non-normally distributed data to compare scores before and after the Imaginator intervention.||||||0.05|||||||Wilcoxon (Mann-Whitney)|||||||0.05
72444367|NCT06311084|144402982|OTHER|We used Wilcoxon Signed-Rank Test for our non-normally distributed data to compare scores before and after the Imaginator intervention.||||||0.05|||||||Wilcoxon (Mann-Whitney)|||||||0.05
72444368|NCT06311084|144402983|OTHER|We used Wilcoxon Signed-Rank Test for our non-normally distributed data to compare scores before and after the Imaginator intervention.||||||0.05|||||||Wilcoxon (Mann-Whitney)|||||||0.05
72444369|NCT06311084|144402984|OTHER|We used Wilcoxon Signed-Rank Test for our non-normally distributed data to compare scores before and after the Imaginator intervention.||||||0.05|||||||Wilcoxon (Mann-Whitney)|||||||0.05
72444370|NCT06311084|144402985|OTHER|We used Wilcoxon Signed-Rank Test for our non-normally distributed data to compare scores before and after the Imaginator intervention.||||||0.05|||||||Wilcoxon (Mann-Whitney)|||||||0.05
72444371|NCT06311084|144402986|OTHER|We used Wilcoxon Signed-Rank Test for our non-normally distributed data to compare scores before and after the Imaginator intervention.||||||0.05|||||||Wilcoxon (Mann-Whitney)|||||||0.05
72444372|NCT06311084|144402987|OTHER|We used Wilcoxon Signed-Rank Test for our non-normally distributed data to compare scores before and after the Imaginator intervention.||||||0.05|||||||Wilcoxon (Mann-Whitney)|||||||0.05
72444373|NCT06311084|144402988|OTHER|We used Wilcoxon Signed-Rank Test for our non-normally distributed data to compare scores before and after the Imaginator intervention.||||||0.05|||||||Wilcoxon (Mann-Whitney)|||||||0.05
72444374|NCT06311084|144402989|OTHER|We used Wilcoxon Signed-Rank Test for our non-normally distributed data to compare scores before and after the Imaginator intervention.||||||0.05|||||||Wilcoxon (Mann-Whitney)|||||||0.05
72444375|NCT06311084|144402990|OTHER|We used Wilcoxon Signed-Rank Test for our non-normally distributed data to compare scores before and after the Imaginator intervention.||||||0.05|||||||Wilcoxon (Mann-Whitney)|||||||0.05
72444376|NCT06311084|144402991|OTHER|We used Wilcoxon Signed-Rank Test for our non-normally distributed data to compare scores before and after the Imaginator intervention.||||||0.05|||||||Wilcoxon (Mann-Whitney)|||||||0.05
72444377|NCT06311084|144402992|OTHER|We used Wilcoxon Signed-Rank Test for our non-normally distributed data to compare scores before and after the Imaginator intervention.||||||0.05|||||||Wilcoxon (Mann-Whitney)|||||||0.05
72619194|NCT01655069|144769067|OTHER||Adjusted change from baseline|-2.0|STANDARD_ERROR_OF_MEAN|0.42|||TWO_SIDED|95.0|-2.83|-1.17|||Repeated Measures ANCOVA|Duration of solifenacin treatment: 52 weeks||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant."||-1.17|-2.83|
72619195|NCT01655069|144769068|OTHER||Adjusted change from baseline|1.35|STANDARD_ERROR_OF_MEAN|0.19|||TWO_SIDED|95.0|0.97|1.73|||Repeated Measures ANCOVA|Duration of solifenacin treatment: 3 weeks||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant."||1.73|0.97|
72619196|NCT01655069|144769068|OTHER||Adjusted change from baseline|1.43|STANDARD_ERROR_OF_MEAN|0.2|||TWO_SIDED|95.0|1.02|1.83|||Repeated Measures ANCOVA|Duration of solifenacin treatment: 6 weeks||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant."||1.83|1.02|
72444378|NCT06311084|144402993|OTHER|We used Wilcoxon Signed-Rank Test for our non-normally distributed data to compare scores before and after the Imaginator intervention.||||||0.05|||||||Wilcoxon (Mann-Whitney)|||||||0.05
72619197|NCT01655069|144769068|OTHER||Adjusted change from baseline|1.72|STANDARD_ERROR_OF_MEAN|0.22|||TWO_SIDED|95.0|1.27|2.16|||Repeated Measures ANCOVA|Duration of solifenacin treatment: 9 weeks||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant."||2.16|1.27|
72619198|NCT01655069|144769068|OTHER||Adjusted change from baseline|1.8|STANDARD_ERROR_OF_MEAN|0.22|||TWO_SIDED|95.0|1.36|2.24|||Repeated Measures ANCOVA|Duration of solifenacin treatment: 12 weeks||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant."||2.24|1.36|
72619199|NCT01655069|144769068|OTHER||Adjusted change from baseline|2.21|STANDARD_ERROR_OF_MEAN|0.23|||TWO_SIDED|95.0|1.74|2.67|||Repeated Measures ANCOVA|Duration of solifenacin treatment: 24 weeks||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant."||2.67|1.74|
72444379|NCT03988634|144402994|SUPERIORITY||Geometric Mean Ratio|0.8546||||0.0492|TWO_SIDED|95.0|0.7307|0.9994|||ANCOVA||Geometric Mean Ratio: sac/val vs valsartan|||0.9994|0.7307|0.0492
72444380|NCT03988634|144402995|SUPERIORITY||Win Ratio|1.193||||0.1578|TWO_SIDED|95.0|0.934|1.524|||unmatched pairwise win-ratio||A win ratio greater than 1 was in favor of sacubitril/valsartan arm|||1.524|0.934|0.1578
72444381|NCT03988634|144402996|SUPERIORITY||rate ratio|0.8346||||0.3563|TWO_SIDED|95.0|0.5684|1.2255|||LWYY model||A rate ratio \< 1 indicates an effect in favor of LCZ696|||1.2255|0.5684|0.3563
72444382|NCT03988634|144402997|SUPERIORITY||Rate ratio|0.6249||||0.3155|TWO_SIDED|95.0|0.2496|1.5649|||negative binomial regression model|||||1.5649|0.2496|0.3155
72444383|NCT03988634|144402998|SUPERIORITY||ratio of the change|0.9316||||0.4766|TWO_SIDED|95.0|0.7661|1.1329|||ANCOVA|||||1.1329|0.7661|0.4766
72444384|NCT03988634|144402999|SUPERIORITY||ratio of the change|0.8268|||<|0.0001|TWO_SIDED|95.0|0.76|0.91|||ANCOVA|||Week 4||0.91|0.76|<.0001
72444385|NCT03988634|144402999|SUPERIORITY||ratio of the change|0.8103|||<|0.0001|TWO_SIDED|95.0|0.74|0.89|||ANCOVA|||Week 8||0.89|0.74|<.0001
72444386|NCT04725240|144403002|OTHER||||||<|0.0001||||||Threshold for significance at 0.001 level.|One-sided exact binomial test|||||||<0.0001
72444387|NCT04725240|144403003|OTHER||||||<|0.0001||||||Threshold for significance at 0.001 level.|One-sided exact binomial test|||||||<0.0001
72444388|NCT04725240|144403004|OTHER||||||<|0.0001||||||Threshold for significance at 0.001 level.|One-sided exact binomial test|||||||<0.0001
72497274|NCT00618722|144524341|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1||||0.436|TWO_SIDED|95.0|-0.2|0.4|||Repeated measures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 24||0.4|-0.2|0.436
72444389|NCT04725240|144403005|OTHER||||||<|0.0001||||||Threshold for significance at 0.001 level.|One-sided exact binomial test|||||||<0.0001
72469476|NCT03494985|144462696|OTHER||Least square mean difference|0.6|||<|0.0001|TWO_SIDED|95.0|0.4|0.9||p-value was adjusted using Dunnett's method for multiple comparisons|ANOVA|ANOVA model with factors for treatment, study site and DMI stratification (mild, moderate, severe).|First named treatment minus second named treatment such that a positive value favours the first named treatment.|||0.9|0.4|<0.0001
72444390|NCT01351805|144403033|OTHER|Test of change from baseline as above.|Percent change in geometric means|8.19||||0.02|TWO_SIDED|95.0|1.52|15.31||IL-6 from baseline to one year: overall % change= 8.19% (95%CI 1.52-15.31).|as above|p above adjusted for age, sex, race and n-3 fatty acid randomized treatment group.||Geometric means of biomarker concentrations with 95% CIs were calculated for baseline and 1 year biomarkers (IL-6, TNFR2 and CRP) by treatment group (active vs. placebo vitamin D). Linear repeated measures models calculated the % change in means for each biomarker from baseline to year one and the overall effects of randomized treatments with 95% CIs.||15.31|1.52|0.02
72444391|NCT01351805|144403033|OTHER|Test of change from baseline as above.|Percent change in geometric means|-0.73||||0.97|TWO_SIDED|95.0|-6.87|5.81||4\. IL-6 from baseline to one year: overall % change= -0.73% (95%CI -6.87 to 5.81).|as above|p above adjusted for age, sex, race and vitamin D randomized treatment group.||Geometric means of biomarker concentrations with 95% CIs were calculated for baseline and 1 year biomarkers (IL-6, TNFR2 and CRP) by treatment group (active vs. placebo vitamin D). Linear repeated measures models calculated the % change in means for each biomarker from baseline to year one and the overall effects of randomized treatments with 95% CIs.||5.81|-6.87|0.97
72444392|NCT01351805|144403033|SUPERIORITY|Multiplicative interaction between strata based on linear models of ln biomarker from baseline to year 1,p for interaction between strata.||||||0.12||||||Test of multiplicative interaction between the effects of the two supplements|p for interaction|||Test for interaction between effect of vitamin D and effect of omega-3 fatty acids on IL-6 change from baseline to 1 year||||0.12
72444393|NCT01351805|144403034|OTHER|Test of change from baseline as above.|Percent change in geometric means|7.12||||0.16|TWO_SIDED|95.0|-1.81|16.87||3\. HsCRP from baseline to one year: overall % change= 7.12% (95%CI -1.81-16.78).|as above|p above adjusted for age, sex, race and n-3 fatty acid randomized treatment group.||Geometric means of biomarker concentrations with 95% CIs were calculated for baseline and 1 year biomarkers (IL-6, TNFR2 and CRP) by treatment group (active vs. placebo vitamin D). Linear repeated measures models calculated the % change in means for each biomarker from baseline to year one and the overall effects of randomized treatments with 95% CIs.||16.87|-1.81|0.16
72444394|NCT01351805|144403034|OTHER|Test of change from baseline as above.|Percent change in geometric means|-3.89||||0.44|TWO_SIDED|95.0|-11.92|4.86||6\. HsCRP from baseline to one year: overall % change= -3.89% (95%CI -11.92-4.86).|as above|p above adjusted for age, sex, race and vitamin D randomized treatment group.||Geometric means of biomarker concentrations with 95% CIs were calculated for baseline and 1 year biomarkers (IL-6, TNFR2 and CRP) by treatment group (active vs. placebo vitamin D). Linear repeated measures models calculated the % change in means for each biomarker from baseline to year one and the overall effects of randomized treatments with 95% CIs.||4.86|-11.92|0.44
72444395|NCT01351805|144403034|SUPERIORITY|||||||0.38|||||||P for interaction|||Test for multiplicative interaction between effect of vitamin D and effect of omega-3. based on linear models of ln biomarker from baseline to year 1.||||0.38
72444396|NCT01351805|144403035|OTHER|Test of change from baseline as above.|Percent change in geometric means|0.63||||0.57|TWO_SIDED|95.0|-1.03|2.31||2\. TNFR2 from baseline to one year: overall % change= 0.63% (95%CI -1.03 to 2.31).|as above|p above adjusted for age, sex, race and n-3 fatty acid randomized treatment group.||Geometric means of biomarker concentrations with 95% CIs were calculated for baseline and 1 year biomarkers (IL-6, TNFR2 and CRP) by treatment group (active vs. placebo vitamin D). Linear repeated measures models calculated the % change in means for each biomarker from baseline to year one and the overall effects of randomized treatments with 95% CIs.||2.31|-1.03|0.57
72444397|NCT01351805|144403035|OTHER|Test of change from baseline as above.|Percent change in geometric means|-1.27||||0.13|TWO_SIDED|95.0|-2.89|0.39||5\. TNFR2 from baseline to one year: overall % change= -1.27% (95%CI -2.89 to 0.39).|as above|p above adjusted for age, sex, race and vitamin D randomized treatment group.||Geometric means of biomarker concentrations with 95% CIs were calculated for baseline and 1 year biomarkers (IL-6, TNFR2 and CRP) by treatment group (active vs. placebo vitamin D). Linear repeated measures models calculated the % change in means for each biomarker from baseline to year one and the overall effects of randomized treatments with 95% CIs.||0.39|-2.89|0.13
72444398|NCT01351805|144403035|SUPERIORITY|Multiplicative interaction between strata based on linear models of ln biomarker from baseline to year 1 with p for interaction between strata.||||||0.74|||||||P for interaction|||Test for multiplicative interaction between effect of vitamin D and effect of omega-3. based on linear models of ln biomarker from baseline to year 1.||||0.74
72619200|NCT01655069|144769068|OTHER||Adjusted change from baseline|2.28|STANDARD_ERROR_OF_MEAN|0.25|||TWO_SIDED|95.0|1.79|2.77|||Repeated Measures ANCOVA|Duration of solifenacin treatment: 40 weeks||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant."||2.77|1.79|
72619201|NCT01655069|144769068|OTHER||Adjusted change from baseline|2.84|STANDARD_ERROR_OF_MEAN|0.33|||TWO_SIDED|95.0|2.19|3.49|||Repeated Measures ANCOVA|Duration of solifenacin treatment: 52 weeks||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant."||3.49|2.19|
72444399|NCT01351805|144403036|OTHER||Cox Proportional Hazard|0.78||||0.05|TWO_SIDED|95.0|0.61|0.99|||Regression, Cox|||||0.99|0.61|0.05
72444400|NCT01351805|144403036|SUPERIORITY||Cox Proportional Hazard|0.85||||0.19|TWO_SIDED|95.0|0.67|1.08|||Regression, Cox|||||1.08|0.67|0.19
72444401|NCT01351805|144403036|SUPERIORITY|||||||0.2|||||||P for interaction|p multiplicative interaction between effects of vitamin D and n-3 fa supplements||Test for multiplicative interaction between the effects of randomized treatment groups, vitamin D and n-3 fa on incidence of autoimmune disease.||||0.20
72497275|NCT00618722|144524342|SUPERIORITY_OR_OTHER||LS Mean Difference|1.6||||0.762|TWO_SIDED|95.0|-9.1|12.3|||ANCOVA|Based on analysis of covariance (ANCOVA) model with treatment as fixed effect and baseline SMF rating as covariate.||||12.3|-9.1|0.762
72497276|NCT00618722|144524342|SUPERIORITY_OR_OTHER||LS mean Difference|5.2||||0.248|TWO_SIDED|95.0|-3.8|14.2|||ANCOVA|Based on analysis of covariance (ANCOVA) model with treatment as fixed effect and baseline SMF rating as covariate.||||14.2|-3.8|0.248
72497277|NCT00618722|144524342|SUPERIORITY_OR_OTHER||LS Mean Difference|9.3||||0.061|TWO_SIDED|95.0|-0.4|19.1|||ANCOVA|Based on analysis of covariance (ANCOVA) model with treatment as fixed effect and baseline SMF rating as covariate.||||19.1|-0.4|0.061
72497278|NCT00624221|144524344|NON_INFERIORITY_OR_EQUIVALENCE|The sample size of 40 subjects was estimated based on having 80% power to determine greater than 10% difference in cell loss between groups with estimated standard deviation of 17 and estimated correlation of 0.5.||||||0.1|TWO_SIDED|95.0|||||paired difference t-test|||||||0.10
72444402|NCT01351805|144403037|OTHER|We assessed the main effects of the treatment arms comparing all those randomized to omega-3 fatty acids or omega-3 fatty acid placebo, regardless of vitamin D randomization status.||||||0.77||||||Repeated measures model with unstructured variance to assess effect of treatment on WOMAC Pain adjusting for age, sex, and other treatment. Linear time by treatment interaction term assessed change in WOMAC Pain over time in treatment vs placebo.|Mixed Models Analysis|Repeated measures model with censoring for total knee replacement.||Intention to treat analysis using a repeated measures model with unstructured variance to assess the effect of treatment arm on WOMAC Pain adjusting for age, sex, and the other treatment arm. The linear time by treatment interaction term assessed change in WOMAC Pain over time between participants randomized to treatment versus placebo.||||0.77
72444403|NCT01351805|144403037|OTHER|We assessed the main effects of the treatment arms comparing all those randomized to vitamin D or vitamin D placebo, regardless of omega-3 fatty acid randomization status.||||||0.41||||||Repeated measures model with unstructured variance to assess effect of treatment on WOMAC Pain adjusting for age, sex, and other treatment. Linear time by treatment interaction term assessed change in WOMAC Pain over time in treatment vs placebo.|Mixed Models Analysis|Linear time by treatment interaction (comparing change in WOMAC pain over time in two randomized groups)||Intention to treat analysis using a repeated measures model with unstructured variance to assess the effect of treatment arm on WOMAC Pain adjusting for age, sex, and the other treatment arm. The linear time by treatment interaction term assessed change in WOMAC Pain over time between participants randomized to treatment versus placebo.|We assessed for effect modification between vitamin D and N-3 FA and tested for other pre-specified interactions. We again used a repeated measures model with censoring for TKR. We adjusted for age, sex and N-3 FA treatment arm (in analyses in which N-3 FA treatment arm was not investigated as a potential modifier).|||0.41
72444404|NCT01351805|144403037|OTHER|Linear regression - WOMAC pain over time mean (Standard error - SE). Differences in WOMAC pain scores in stratified groups.|Mean Difference (Net)|-1.5|STANDARD_ERROR_OF_MEAN|1.9||0.42|TWO_SIDED||||||Regression, Linear|||Active n3fa vs placebo n3fa among those on placebo vitamin D.||||0.42
72444405|NCT01351805|144403037|OTHER|Linear regression - WOMAC pain over time mean (Standard error - SE). Differences in WOMAC pain scores in stratified groups.|Mean Difference (Net)|-2.5|STANDARD_ERROR_OF_MEAN|1.8||0.18|TWO_SIDED||||||Regression, Linear|||Vitamin D vs. vitamin D placebo among those on placebo omega-3 fatty acids- stratified analyses.||||0.18
72444406|NCT01351805|144403037|OTHER|Linear regression - WOMAC pain over time mean (Standard error - SE). Report only in final year. Differences in WOMAC pain scores in cross-classified groups.|Mean Difference (Net)|0.39|STANDARD_ERROR_OF_MEAN|1.89||0.84|TWO_SIDED||||||Regression, Linear|||Omega-3 fatty acids vs. omega-3 fatty acids placebo among those on active vitamin D.||||0.84
72444407|NCT01351805|144403037|OTHER|Linear regression - WOMAC pain over time mean (Standard error - SE). Report only in final year. Differences in WOMAC pain scores in cross-classified groups.|Mean Difference (Net)|-0.55|STANDARD_ERROR_OF_MEAN|1.8||0.76|TWO_SIDED||||||Regression, Linear|||Omega-3 fatty acids vs. omega-3 fatty acids placebo among those on placebo vitamin D.||||0.76
72497279|NCT00200057|144524347|SUPERIORITY_OR_OTHER||Proportion|0.73|||<|0.0001|TWO_SIDED|95.0|0.64|0.81||No multiplicity adjustments were made for the primary outcome analysis. Two-tailed p-values were considered statistically significant if they were less than 0.05.|Exact Binomial|||The exact Binomial test (two-sided) for one-sample proportions was used to test the null hypothesis that the success rate is equal to 0.5.||0.81|0.64|<0.0001
72444408|NCT05862870|144403047|OTHER|Frequency count|exact count|20.0|STANDARD_DEVIATION|0.0||0.05|TWO_SIDED|0.0|20.0|20.0|||count|||Frequency count of patients retained in treatment.|Threshold for frequency count|20|20|.05
72497280|NCT00200057|144524348|SUPERIORITY_OR_OTHER||Proportion|0.73|||<|0.0001|TWO_SIDED|95.0|0.64|0.81||The Hochberg procedure for multiplicity adjustment was used for all secondary objectives.|Exact Binomial|||The exact Binomial test (two-sided) for one-sample proportions was used to test the null hypothesis that the success rate is equal to 0.5.||0.81|0.64|<0.0001
72497281|NCT00200057|144524349|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||The Hochberg procedure for multiplicity adjustment was used for all secondary objectives.|Wilcoxon signed-rank test|||||||<0.0001
72497282|NCT00200057|144524350|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||The Hochberg procedure for multiplicity adjustment was used for all secondary objectives.|Wilcoxon signed-rank test|||||||<0.0001
72497283|NCT00200057|144524351|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||The Hochberg procedure for multiplicity adjustment was used for all secondary objectives.|Wilcoxon signed-rank test|||||||<0.0001
72497284|NCT00200057|144524352|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||The Hochberg procedure for multiplicity adjustment was used for all secondary objectives.|Wilcoxon signed-rank test|||||||<0.0001
72497285|NCT00200057|144524353|SUPERIORITY_OR_OTHER||Proportion|0.71|||<|0.0001|TWO_SIDED|95.0|0.62|0.79||The Hochberg procedure for multiplicity adjustment was used for all secondary objectives.|Exact Binomial|||The exact Binomial test (two-sided) for one-sample proportions was used to test the null hypothesis that the success rate is equal to 0.5.||0.79|0.62|<0.0001
72497286|NCT05197803|144524369|SUPERIORITY||Mean Difference (Final Values)|3.32||||0.0001|ONE_SIDED||||||t-test, 1 sided|||The study compared the results between the unaided condition vs. aided condition (BTE)||||0.0001
72444409|NCT04936035|144403086|SUPERIORITY||Difference in LS Mean|-16.7|STANDARD_ERROR_OF_MEAN|1.9|<|0.0001|TWO_SIDED|95.0|-21.2|-12.3||MMRM model included treatment, visit, treatment-by-visit interaction, and race (categorized as Black and all other races) as fixed factors, with baseline 24-hour mean SBP assessed by ABPM as a covariate.|MMRM|The adjusted 95% CI and p-value are based on Dunnett's test.|LS Mean Difference between zilebesiran 300 mg Q6M and placebo, 95% CI was calculated using Dunnett's procedure.|||-12.3|-21.2|<0.0001
72444410|NCT04936035|144403086|SUPERIORITY||Difference in LS Mean|-15.7|STANDARD_ERROR_OF_MEAN|2.19|<|0.0001|TWO_SIDED|95.0|-20.8|-10.6||The MMRM model included treatment, visit, treatment-by-visit interaction, and race (categorized as Black and all other races) as fixed factors, with baseline 24-hour mean SBP assessed by ABPM as a covariate.|MMRM|The adjusted 95% CI and p-value are based on Dunnett's test.|LS Mean Difference between zilebesiran 600 mg Q6M and placebo, 95% CI was calculated using Dunnett's procedure.|||-10.6|-20.8|<0.0001
72444411|NCT04936035|144403087|SUPERIORITY||Difference in LS Mean|-12.0|STANDARD_ERROR_OF_MEAN|1.89|<|0.0001|TWO_SIDED|95.0|-15.7|-8.3||The MMRM model included treatment, visit, treatment-by-visit interaction, and race (categorized as Black and all other races) as fixed factors, with office SBP as a covariate.|MMRM|Tested in hierarchical order with success criterion of nominal p-value \<0.05.||||-8.3|-15.7|<0.0001
72444412|NCT04936035|144403087|SUPERIORITY||Difference in LS Mean|-9.1|STANDARD_ERROR_OF_MEAN|2.19|<|0.0001|TWO_SIDED|95.0|-13.4|-4.8||The MMRM model included treatment, visit, treatment-by-visit interaction, and race (categorized as Black and all other races) as fixed factors, with office SBP as a covariate.|MMRM|Tested in hierarchical order with success criterion of nominal p-value \<0.05.||||-4.8|-13.4|<0.0001
72444413|NCT04936035|144403088|SUPERIORITY||Difference in LS Mean|-14.1|STANDARD_ERROR_OF_MEAN|2.4|<|0.0001|TWO_SIDED|95.0|-18.9|-9.4||The MMRM model included treatment, visit, treatment-by-visit interaction, and race (categorized as Black and all other races) as fixed factors, with baseline 24-hour mean SBP assessed by ABPM as a covariate.|MMRM|Tested in hierarchical order with success criterion of nominal p-value \<0.05.||||-9.4|-18.9|<0.0001
72444414|NCT04936035|144403088|SUPERIORITY||Difference in LS Mean|-14.2|STANDARD_ERROR_OF_MEAN|2.38|<|0.0001|TWO_SIDED|95.0|-18.9|-9.5||The MMRM model included treatment, visit, treatment-by-visit interaction, and race (categorized as Black and all other races) as fixed factors, with baseline 24-hour mean SBP assessed by ABPM as a covariate.|MMRM|Tested in hierarchical order with success criterion of nominal p-value \<0.05.||||-9.5|-18.9|<0.0001
72444415|NCT04936035|144403089|SUPERIORITY||Difference in LS Mean|-12.1|STANDARD_ERROR_OF_MEAN|2.55|<|0.0001|TWO_SIDED|95.0|-17.2|-7.1||The MMRM model included treatment, visit, treatment-by-visit interaction, and race (categorized as Black and all other races) as fixed factors, with office SBP as a covariate.|MMRM|Tested in hierarchical order with success criterion of nominal p-value \<0.05.||||-7.1|-17.2|<0.0001
72619202|NCT01655069|144769068|OTHER||Adjusted change from baseline|1.53|STANDARD_ERROR_OF_MEAN|0.69|||TWO_SIDED|95.0|0.17|2.89|||Repeated Measures ANCOVA|Duration of solifenacin treatment: 3 weeks||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant."||2.89|0.17|
72444416|NCT04936035|144403089|SUPERIORITY||Difference in LS Mean|-10.2|STANDARD_ERROR_OF_MEAN|2.5|<|0.0001|TWO_SIDED|95.0|-15.1|-5.3||The MMRM model included treatment, visit, treatment-by-visit interaction, and race (categorized as Black and all other races) as fixed factors, with office SBP as a covariate.|MMRM|Tested in hierarchical order with success criterion of nominal p-value \<0.05.||||-5.3|-15.1|<0.0001
72444417|NCT04936035|144403090|SUPERIORITY||Odds Ratio (OR)|10.73|||<|0.0001|TWO_SIDED|95.0|3.76|30.64||Logistic regression model included treatment and race (black; all other races) as factors and baseline 24-hour mean SBP as a covariate|Regression, Logistic|Tested in hierarchical order with success criterion of nominal p-value \<0.05.||||30.64|3.76|<0.0001
72444418|NCT04936035|144403090|SUPERIORITY||Odds Ratio (OR)|17.93|||<|0.0001|TWO_SIDED|95.0|6.24|51.52||Logistic regression model included treatment and race (black; all other races) as factors and baseline 24-hour mean SBP as a covariate|Regression, Logistic|Tested in hierarchical order with success criterion of nominal p-value \<0.05.||||51.52|6.24|<0.0001
72444419|NCT05529966|144403129|OTHER|||||||0.45490734||||||The a priori threshold for statistical significance after Bonferroni correction is \< 0.002083333|t-test, 2 sided|||||||0.45490734
72444420|NCT05529966|144403130|OTHER|||||||0.9237611||||||The a priori threshold for statistical significance after Bonferroni correction is \< 0.002083333|t-test, 2 sided|||||||0.92376110
72444421|NCT05529966|144403131|OTHER|||||||0.94342221||||||The a priori threshold for statistical significance after Bonferroni correction is \< 0.002083333|t-test, 2 sided|||||||0.94342221
72444422|NCT05529966|144403132|OTHER|||||||0.38902793||||||The a priori threshold for statistical significance after Bonferroni correction is \< 0.002083333|t-test, 2 sided|||||||0.38902793
72444423|NCT05529966|144403133|OTHER|||||||0.0042494||||||The a priori threshold for statistical significance after Bonferroni correction is \< 0.002083333|t-test, 2 sided|||Analysis of comfort score||||0.00424940
72444424|NCT05529966|144403133|OTHER|||||||0.00223547||||||The a priori threshold for statistical significance after Bonferroni correction is \< 0.002083333|t-test, 2 sided|||Analysis of Visibility score||||.00223547
72444425|NCT05529966|144403133|OTHER|||||||1.858e-05||||||The a priori threshold for statistical significance after Bonferroni correction is \< 0.002083333|t-test, 2 sided|||Analysis of Image Quality score||||.00001858
72444426|NCT05529966|144403133|OTHER|||||||0.03003194||||||The a priori threshold for statistical significance after Bonferroni correction is \< 0.002083333|t-test, 2 sided|||Analysis of Focus score||||.03003194
72444427|NCT05529966|144403133|OTHER|||||||2.8e-07||||||The a priori threshold for statistical significance after Bonferroni correction is \< 0.002083333|t-test, 2 sided|||Analysis of Depth Perception score||||.00000028
72444428|NCT05529966|144403133|OTHER|||||||0.00112148||||||The a priori threshold for statistical significance after Bonferroni correction is \< 0.002083333|t-test, 2 sided|||Analysis of Staff Engagement score||||.00112148
72444429|NCT05529966|144403133|OTHER|||||||951||||||The a priori threshold for statistical significance after Bonferroni correction is \< 0.002083333|t-test, 2 sided|||Analysis of Teaching score||||00000951
72444430|NCT05529966|144403133|OTHER|||||||0.03493564||||||The a priori threshold for statistical significance after Bonferroni correction is \< 0.002083333|t-test, 2 sided|||Analysis of En Face Confidence score||||.03493564
72560290|NCT01097694|144651168|SUPERIORITY||||||<|0.05|||||||Mixed Models Analysis|adjusted for baseline values||For FEV1 we used a linear mixed-effects model to assess the between-group difference in the change from baseline over weeks 8-24.||||<0.05
72560291|NCT01097694|144651169|SUPERIORITY|||||||0.06|||||||Mixed Models Analysis|Adjusted for baseline.||For FEV1% we used a linear mixed-effects model to assess the between-group difference in the change from baseline over weeks 8-24.||||0.06
72560292|NCT01097694|144651170|SUPERIORITY|||||||0.38|||||||Mixed Models Analysis|Adjusted for baseline||||||0.38
72560293|NCT01097694|144651171|SUPERIORITY|||||||0.31|||||||Mixed Models Analysis|Adjusted for baseline.||||||0.31
72619203|NCT01655069|144769068|OTHER||Adjusted change from baseline|1.9|STANDARD_ERROR_OF_MEAN|0.7|||TWO_SIDED|95.0|0.52|3.27|||Repeated Measures ANCOVA|Duration of solifenacin treatment: 6 weeks||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant."||3.27|0.52|
72444431|NCT05529966|144403133|OTHER|||||||0.12895248||||||The a priori threshold for statistical significance after Bonferroni correction is \< 0.002083333|t-test, 2 sided|||Analysis of Hydrus Placement Confidence score||||.12895248
72444432|NCT05529966|144403133|OTHER|||||||0.00279611||||||The a priori threshold for statistical significance after Bonferroni correction is \< 0.002083333|t-test, 2 sided|||Analysis of Scope Preference score||||.00279611
72444433|NCT05529966|144403134|OTHER|||||||0.959638658||||||The a priori threshold for statistical significance after Bonferroni correction is \< 0.002083333|t-test, 2 sided|||Analysis of Comfort score||||.959638658
72444434|NCT05529966|144403134|OTHER|||||||0.213464715||||||The a priori threshold for statistical significance after Bonferroni correction is \< 0.002083333|t-test, 2 sided|||Analysis of Visibility score||||.213464715
72444435|NCT05529966|144403134|OTHER|||||||0.213464715||||||The a priori threshold for statistical significance after Bonferroni correction is \< 0.002083333|t-test, 2 sided|||Analysis of Image Quality score||||.213464715
72444436|NCT05529966|144403134|OTHER|||||||0.155899777||||||The a priori threshold for statistical significance after Bonferroni correction is \< 0.002083333|t-test, 2 sided|||Analysis of Focus score||||.155899777
72444437|NCT05529966|144403134|OTHER|||||||0.055960023||||||The a priori threshold for statistical significance after Bonferroni correction is \< 0.002083333|t-test, 2 sided|||Analysis of Depth Perception score||||.055960023
72444438|NCT05529966|144403134|OTHER|||||||0.000685499||||||The a priori threshold for statistical significance after Bonferroni correction is \< 0.002083333|t-test, 2 sided|||Analysis of Staff Engagement score||||.000685499
72560294|NCT01097694|144651172|SUPERIORITY|||||||0.11|||||||Regression, Linear|Adjusted for baseline||||||0.11
72560295|NCT01097694|144651173|SUPERIORITY|||||||0.31|||||||Regression, Linear|Adjusted for baseline.||||||0.31
72560296|NCT01097694|144651174|SUPERIORITY|||||||0.11|||||||Regression, Linear|Adjusted for baseline||||||0.11
72560297|NCT01097694|144651175|SUPERIORITY|||||||0.62|||||||Regression, Linear|Adjusted for baseline.||||||0.62
72560298|NCT01097694|144651176|SUPERIORITY|||||||0.57|||||||Regression, Linear|Adjusted for baseline.||||||0.57
72560299|NCT01097694|144651177|SUPERIORITY|||||||0.15|||||||Regression, Linear|Adjusted for baseline||||||0.15
72560300|NCT01097694|144651178|SUPERIORITY|||||||0.33|||||||Regression, Linear|Adjusted for baseline.||||||0.33
72560301|NCT01097694|144651179|SUPERIORITY|||||||0.11|||||||Regression, Linear|Adjusted for baseline.||||||0.11
72560302|NCT01097694|144651180|SUPERIORITY|||||||0.07|||||||Regression, Linear|Adjusted for baseline.||||||0.07
72560303|NCT01097694|144651181|SUPERIORITY|||||||0.94|||||||Regression, Linear|Adjusted for baseline.||||||0.94
72560304|NCT01097694|144651182|SUPERIORITY|||||||0.13|||||||Regression, Linear|Adjusted for baseline||||||0.13
72560305|NCT01097694|144651183|SUPERIORITY|||||||0.25|||||||Regression, Linear|Adjusted for baseline||||||0.25
72560306|NCT01097694|144651184|SUPERIORITY|||||||0.54|||||||Regression, Linear|Adjusted for baseline.||||||0.54
72560307|NCT01097694|144651185|SUPERIORITY|||||||0.18|||||||Regression, Linear|Adjusted for baseline.||||||0.18
72560308|NCT01097694|144651186|SUPERIORITY|||||||0.56|||||||Regression, Linear|Adjusted for baseline.||||||0.56
72619204|NCT01655069|144769068|OTHER||Adjusted change from baseline|1.75|STANDARD_ERROR_OF_MEAN|0.69|||TWO_SIDED|95.0|0.39|3.1|||Repeated Measures ANCOVA|Duration of solifenacin treatment: 9 weeks||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant."||3.10|0.39|
72444439|NCT05529966|144403134|OTHER|||||||0.004526118||||||The a priori threshold for statistical significance after Bonferroni correction is \< 0.002083333|t-test, 2 sided|||Analysis of Teaching score||||.004526118
72444440|NCT05529966|144403134|OTHER|||||||0.299921137||||||The a priori threshold for statistical significance after Bonferroni correction is \< 0.002083333|t-test, 2 sided|||Analysis of En Face Confidence score||||.299921137
72444441|NCT05529966|144403134|OTHER|||||||0.368082084||||||The a priori threshold for statistical significance after Bonferroni correction is \< 0.002083333|t-test, 2 sided|||Analysis of Hydrus Placement Confidence score||||.368082084
72444442|NCT05529966|144403134|OTHER|||||||0.015036417||||||The a priori threshold for statistical significance after Bonferroni correction is \< 0.002083333|t-test, 2 sided|||Analysis of Scope Preference score||||.015036417
72444443|NCT05338086|144403135|EQUIVALENCE|The estimated mean difference in %CfB lumbar spine BMD at Month 12 was presented with 95% CI and equivalence was concluded if this fell within the predefined equivalence margin of \[-1.45%, 1.45%\].|Mean Difference (Final Values)|0.2|||||TWO_SIDED|95.0|-0.51|0.91||Mixed-model for repeated measures (MMRM)|Mixed Models Analysis|MMRM included treatment, with stratification variables as classification factors and baseline BMD as a continuous covariate.||||0.91|-0.51|
72469477|NCT03494985|144462696|OTHER||LS mean difference|0.9|||<|0.0001|TWO_SIDED|95.0|0.6|1.2||p-value was adjusted using Dunnett's method for multiple comparisons|ANOVA|ANOVA model with factors for treatment, study site and DMI stratification (mild, moderate, severe).|First named treatment minus second named treatment such that a positive value favours the first named treatment.|||1.2|0.6|<0.0001
72560309|NCT01097694|144651187|SUPERIORITY|||||||0.47|||||||Regression, Linear|Adjusted for baseline.||||||0.47
72389057|NCT01663532|144286226|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.6|||<|0.0001|TWO_SIDED|95.0|-3.7|-1.4|||Mixed Models Analysis|MMRM analysis with treatment, pooled centers, Week and treatment-by-Week, and Baseline-by-Week interaction as an unstructured covariate was performed.|Difference in Least Square (LS) mean of change and 95% Confidence interval were derived from pair-wise comparison within MMRM at Week 8.|Null hypothesis of change from Baseline in PANSS total score of aripiprazole IM depot 400/300mg group is same as that of placebo group was tested.||-1.4|-3.7|<.0001
72389058|NCT01663532|144286226|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.8|||<|0.0001|TWO_SIDED|95.0|-4.1|-1.6|||Mixed Models Analysis|MMRM analysis with treatment, pooled centers, Week and treatment-by-Week, and Baseline-by-Week interaction as an unstructured covariate was performed.|Difference in Least Square (LS) mean of change and 95% Confidence interval were derived from pair-wise comparison within MMRM at Week 10.|Null hypothesis of change from Baseline in PANSS total score of aripiprazole IM depot 400/300mg group is same as that of placebo group was tested.||-1.6|-4.1|<.0001
72389059|NCT01663532|144286227|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.1|||<|0.0001|TWO_SIDED|95.0|4.1|10.1|||ANCOVA|ANCOVA model with treatment and pooled centers as factors and Baseline value as covariate for the comparison at other visits.|Difference in least square mean of change were derived from ANCOVA model.|Statistical analysis for Week 10.||10.1|4.1|<.0001
72389060|NCT01663532|144286228|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Cochran-Mantel-Haenszel|CMH raw mean scores differ test (Van Elteren test) controlling for pooled centers.||Statistical analysis for Week 10. LOCF method were used in imputation of missing data.||||<.0001
72389061|NCT01663532|144286229|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|22.7|||<|0.0001|TWO_SIDED|95.0|12.9|32.4|||Cochran-Mantel-Haenszel|CMH test controlling by region (pooled sites).||Statistical analysis for Week 10. LOCF method were used in imputation of missing data.||32.4|12.9|<.0001
72389062|NCT02785432|144286230|SUPERIORITY|||||||0.55||||||Between group comparison at 8 weeks|Wilcoxon (Mann-Whitney)|||||||0.55
72389063|NCT02785432|144286231|SUPERIORITY|||||||0.66||||||Between group comparison at 8 weeks|Wilcoxon (Mann-Whitney)|||||||0.66
72389064|NCT02785432|144286232|SUPERIORITY|||||||0.51||||||Between group comparison at 8 weeks|Wilcoxon (Mann-Whitney)|||||||0.51
72389065|NCT02785432|144286233|SUPERIORITY|||||||0.96||||||Between group comparison at 8 weeks|Wilcoxon (Mann-Whitney)|||||||0.96
72389066|NCT01633853|144286234|SUPERIORITY_OR_OTHER|||||||0.117|TWO_SIDED||||||t-test, 2 sided|||The blood levels of calcium at the 24th month of following up were compared to the levels of the baseline both in group Vitamin D2.||||0.117
72389067|NCT01633853|144286234|SUPERIORITY_OR_OTHER|||||||0.309|TWO_SIDED||||||t-test, 2 sided|||The blood levels of calcium at the 24th month of following up were compared to the levels of the baseline in group 1,25(OH)2 Vitamin D3.||||0.309
72389068|NCT01633853|144286234|SUPERIORITY_OR_OTHER|||||||0.554|TWO_SIDED|||||t=-0.593|t-test, 2 sided|||The levels of blood calcium at the 24th month of following up were compared between two groups.||||0.554
72389069|NCT01633853|144286235|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||t-test, 2 sided|||The levels of blood 25(OH)Vitamin D were compared between the 24th month and the baseline in group Vitamin D2.||||<0.001
72389070|NCT01633853|144286235|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||t-test, 2 sided|||The levels of blood 25(OH)Vitamin D were compared between the 24th month and the baseline in group 1,25(OH)2 Vitamin D3.||||<0.001
72389071|NCT01633853|144286235|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||P\<0.001, t=-14.982.|t-test, 2 sided|||The levels of blood 25(OH) Vitamin D at the 24th month of following up were compared between two groups.||||<0.001
72389072|NCT01633853|144286236|SUPERIORITY_OR_OTHER|||||||0.753|TWO_SIDED|||||Chi-square value=0.099|Chi-squared|||||||0.753
72389073|NCT01633853|144286237|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||t-test, 2 sided|||The levels of blood phosphorus were compared between the 24th month of following up and the baseline in group Vitamin D2.||||<0.001
72389074|NCT01633853|144286237|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||t-test, 2 sided|||The levels of blood phosphorus were compared between the 24th month of following up and the baseline in group 1,25(OH)2 Vitamin D3, respectively.||||<0.001
72389075|NCT01633853|144286237|SUPERIORITY_OR_OTHER|||||||0.694|TWO_SIDED|||||t=0.394|t-test, 2 sided|||The levels of blood phosphorus at the 24th month of following up were compared between two groups.||||0.694
72389076|NCT01633853|144286238|SUPERIORITY_OR_OTHER|||||||0.179|TWO_SIDED||||||t-test, 2 sided|||The levels of blood iPTH were compared between the 24th month and the baseline in group Vitamin D2.||||0.179
72389077|NCT01633853|144286238|SUPERIORITY_OR_OTHER|||||||0.106|TWO_SIDED||||||t-test, 2 sided|||The levels of blood iPTH were compared between the 24th month and the baseline group 1,25(OH)2 Vitamin D3, respectively.||||0.106
72389078|NCT01633853|144286238|SUPERIORITY_OR_OTHER|||||||0.463|TWO_SIDED|||||t=-0.736|t-test, 2 sided|||The levels of blood iPTH at the 24th month of following up were compared between two groups.||||0.463
72389079|NCT01673867|144286333|SUPERIORITY||Hazard Ratio (HR)|0.73||||0.0015|TWO_SIDED|95.92|0.59|0.89|||Log Rank||HR = Nivolumab over docetaxel|||0.89|0.59|0.0015
72389080|NCT00926328|144286363|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
72389081|NCT00926328|144286364|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
72389082|NCT01227434|144286374|SUPERIORITY_OR_OTHER||Exact binomial distribution|0.1||||0.1|TWO_SIDED||||||Exact binomial distribution|||Compared to historical estimates of PFS-6 months. With 30 patients, there would be 90% power to detect an improvement in the PFS-6 months rate from 10% (historical estimate) to 30% based on a one-sided exact test with alpha=0.1.||||0.10
72389083|NCT01513343|144286376|SUPERIORITY||||||<|0.05|||||||Regression, Logistic|Multinomial logistic regression examined program effects on child BMI categories, controlling for child sex, age (months), \& BMI z-score at pretest.||||||<0.05
72389084|NCT01513343|144286377|SUPERIORITY||||||<|0.05||||||To control for type I errors, the critical P values for each assessment were determined with the unweighted Bonferroni method, dividing the critical value of P \< 0.05 by the number of comparisons conducted for a given assessment.|Mixed Models Analysis|||||||<0.05
72389085|NCT02165215|144286387|SUPERIORITY||Adjusted difference in response rates|7.7||||0.1942|TWO_SIDED|95.0|-4.2|19.2|||Cochran-Mantel-Haenszel|||||19.2|-4.2|0.1942
72444444|NCT05338086|144403136|EQUIVALENCE|The estimated mean difference in %CfB lumbar spine BMD at Month 12 was presented with 95% CI and equivalence was concluded if this fell within the predefined equivalence margin of \[-1.45%, 1.45%\].|Mean Difference (Final Values)|0.03|||||TWO_SIDED|95.0|-0.69|0.74|||ANCOVA|ANCOVA included terms for treatment, with stratification variables as classification factors and baseline BMD included as a continuous covariate.|The estimated mean difference in %CfB lumbar spine BMD results was pooled using Rubin's methods and presented with 95% CI.|||0.74|-0.69|
72444445|NCT05338086|144403139|EQUIVALENCE|Equivalence criteria (analysis set mFAS): 95% CI for ratio of geometric LS mean ratios contained in acceptance limits (80.00%, 125.00%).|Ratio of Geometric means|99.91|||||TWO_SIDED|95.0|91.99|108.52|||ANCOVA|ANCOVA model including log-transformed baseline sCTX as a continuous covariate with treatment and stratification variables as fixed effects.||||108.52|91.99|
72444446|NCT05338086|144403140|EQUIVALENCE|Biosimilarity with respect to PD was concluded if the 95% CI for the test (MB09) to reference (EU-Prolia) ratios of the geometric LS means was contained within the \[80.00%, 125.00%\] interval.|Ratio of Geometric means|99.13|||||TWO_SIDED|95.0|96.31|102.02|||ANCOVA|||||102.02|96.31|
72444447|NCT05338086|144403141|EQUIVALENCE|Equivalence criteria (on Pharmacokinetic Parameter Analysis Set): the 95% CIs around the geometric LS mean contained in the acceptance limits (80.00%, 125.00%)|LS Geometric Mean Ratio|104.13|||||TWO_SIDED|95.0|98.83|109.71|||ANCOVA|Cmax was analysed on the log scale by ANCOVA. The model included treatment and stratification variables as fixed effects.||||109.71|98.83|
72444448|NCT05338086|144403142|EQUIVALENCE|Equivalence criteria (on Pharmacokinetic Parameter Analysis Set): the 95% CIs around the geometric LS mean contained in the acceptance limits (80.00%, 125.00%)|LS Geometric Mean Ratio|106.06|||||TWO_SIDED|95.0|99.84|112.66|||ANCOVA|AUC0-6 months was analysed on the log scale by ANCOVA. The model included treatment and stratification variables as fixed effects.||||112.66|99.84|
72444449|NCT04690673|144403193|EQUIVALENCE|Based on previous reports on the pharmacokinetics of oral paracetamol, the standard deviation of the within-subject difference in the Cmax for paracetamol was estimated to be 35% of the mean Cmax. Using this standard deviation, 10 participants were estimated to be sufficient, with a power of at least 80% (at 5% significance level). We recruited 12 volunteers to account for potential protocol violations or dropouts.|Geometric mean ratio|1.03||||0.05|TWO_SIDED|90.0|0.94|1.13||Not adjusted for multiple comparisons as the analysis was exploratory|t-test, 2 sided||Adhering|Highest paracetamol concentrations (Cmax) measured from capillary with the electrochemical method compared with measurements with mass-spectrometry.||1.13|0.94|0.05
72444450|NCT04850807|144403221|SUPERIORITY||average marginal effect|-0.4|STANDARD_ERROR_OF_MEAN|3.3|<|0.05|TWO_SIDED|95.0|-6.9|6.0|||Differences-in-Differences regression||||"Fixed effect covariates: age, sex, race, activities of daily living score, cognitive function score, psychotic disorder, bipolar disease, depression, anxiety, dementia, alzheimer's diagnosis, antidepressant use, antianxietal use, antipsychotic use, history of heart failure, baseline ARBS (exclusive to CMAI model), baseline CMAI (exclusive to ARBS model), indicator of baseline/follow-up score, treatment group, interaction of treatment group and baseline/follow-up score.~Random effects: random intercept for nursing home, random intercept for the interaction of baseline/follow-up measure and nursing home, and random intercept for individual.~Imputed Outcomes: 37 Control Follow-Up (Both CMAI and ARBS), 37 Treatment Follow-Up (ABRS), 35 Treatment Follow-Up (CMAI)"|6.0|-6.9|<0.05
72444451|NCT04850807|144403222|SUPERIORITY||Average Marginal Effect|0.1|STANDARD_ERROR_OF_MEAN|0.08|<|0.05|TWO_SIDED|95.0|-0.06|0.26|||Differences-in-Differences regression||||"Fixed effect covariates: age, sex, race, activities of daily living score, cognitive function score, psychotic disorder, bipolar disease, depression, anxiety, dementia, alzheimer's diagnosis, antidepressant use, antianxietal use, antipsychotic use, history of heart failure, baseline ARBS (exclusive to CMAI model), baseline CMAI (exclusive to ARBS model), indicator of baseline/follow-up score, treatment group, interaction of treatment group and baseline/follow-up score.~Random effects: random intercept for nursing home, random intercept for the interaction of baseline/follow-up measure and nursing home, and random intercept for individual.~Imputed Outcomes: 37 Control Follow-Up (Both CMAI and ARBS), 37 Treatment Follow-Up (ABRS), 35 Treatment Follow-Up (CMAI)"|0.26|-0.06|<0.05
72444452|NCT04850807|144403223|SUPERIORITY||average marginal effect|4.0|STANDARD_ERROR_OF_MEAN|3.2|<|0.05|TWO_SIDED|95.0|-2.3|10.2|||Differences-in-Differences regression||||"Fixed effect covariates: baseline medication use, age, sex, race, activities of daily living score, cognitive function score, psychotic diagnosis, depression, anxiety, dementia, asthma, ARBS score, treatment group.~Random effects: random intercept for nursing home Imputed Outcomes: 37 Control Follow-Up , 35 Treatment Follow-Up"|10.2|-2.3|<0.05
72444453|NCT04850807|144403224|SUPERIORITY||average marginal effect|-1.4|STANDARD_ERROR_OF_MEAN|3.6|<|0.05|TWO_SIDED|95.0|-8.5|5.6|||Differences-in-Differences regression||||"Results are adjusted for baseline medication use, age, sex, race, activities of daily living score, cognitive function score, psychotic diagnosis, depression, anxiety, dementia, asthma, ARBS score, treatment group.~The model includes a random intercept for nursing home."|5.6|-8.5|<0.05
72444454|NCT04850807|144403225|SUPERIORITY||average marginal effect|-4.8|STANDARD_ERROR_OF_MEAN|2.5|<|0.05|TWO_SIDED|95.0|-9.8|0.1|||Differences-in-Differences regression||||"Fixed effect covariates: baseline medication use, age, sex, race, activities of daily living score, cognitive function score, psychotic diagnosis, depression, anxiety, dementia, asthma, ARBS score, treatment group.~Random effects: random intercept for nursing home Imputed Outcomes: 37 Control Follow-Up , 35 Treatment Follow-Up"|0.1|-9.8|<0.05
72444455|NCT04850807|144403227|SUPERIORITY||average marginal effect|-0.31|||<|0.05|TWO_SIDED|95.0|-1.03|0.41|||Differences-in-Differences regression||||"Fixed effect covariates: age, sex, race, activities of daily living score, cognitive function score, psychotic disorder, bipolar disease, depression, anxiety, dementia, alzheimer's diagnosis, antidepressant use, antianxietal use, antipsychotic use, history of heart failure, baseline ARBS (exclusive to CMAI/PHQ-9 model), baseline CMAI (exclusive to ARBS/PHQ-9 model), indicator of baseline/follow-up score, treatment group, interaction of treatment group and baseline/follow-up score.~Random effects: random intercept for nursing home, random intercept for the interaction of baseline/follow-up measure and nursing home, and random intercept for individual.~Imputed Outcomes: 37 Control Follow-Up (Both CMAI and ARBS), 37 Treatment Follow-Up (ABRS), 35 Treatment Follow-Up (CMAI)"|0.41|-1.03|<0.05
72497287|NCT05197803|144524369|SUPERIORITY||Mean Difference (Final Values)|3.57||||0.0001|ONE_SIDED||||||t-test, 1 sided|||The study compared the results between the unaided condition vs. aided condition (RIC)||||0.0001
72389086|NCT02165215|144286388|SUPERIORITY||Adjusted difference in remission rates|14.6||||0.1524|TWO_SIDED|95.0|-5.55|33.15||p-value has not been adjusted for multiplicity|Cochran-Mantel-Haenszel|||||33.15|-5.55|0.1524
72389087|NCT02165215|144286389|SUPERIORITY||Adjusted difference in remission rates|8.7||||0.1466|TWO_SIDED|95.0|-3.26|20.21||p-value has not been adjusted for multiplicity|Cochran-Mantel-Haenszel|||||20.21|-3.26|0.1466
72389088|NCT02165215|144286390|SUPERIORITY||Adjusted difference in remission rates|10.9||||0.3083||95.0|-9.72|30.49||p-value has not been adjusted for multiplicity|Cochran-Mantel-Haenszel|||||30.49|-9.72|0.3083
72389089|NCT02165215|144286391|SUPERIORITY||Adjusted difference in response rates|14.4||||0.0235|TWO_SIDED|95.0|1.84|26.28||p-value has not been adjusted for multiplicity|Cochran-Mantel-Haenszel|||||26.28|1.84|0.0235
72389090|NCT02165215|144286392|SUPERIORITY||Adjusted difference in remission rates|12.8||||0.0293||95.0|1.13|23.89||p-value has not been adjusted for multiplicity|Cochran-Mantel-Haenszel|||||23.89|1.13|0.0293
72389091|NCT02165215|144286393|SUPERIORITY||Adjusted difference in remission rates|19.8||||0.0075|TWO_SIDED|95.0|5.16|33.11||p-value has not been adjusted for multiplicity|Cochran-Mantel-Haenszel|||||33.11|5.16|0.0075
72389092|NCT02165215|144286394|SUPERIORITY||Adjusted difference in remission rates|9.9||||0.1415||95.0|-4.47|23.13||p-value has not been adjusted for multiplicity|Cochran-Mantel-Haenszel|||||23.13|-4.47|0.1415
72389093|NCT02165215|144286395|SUPERIORITY||Adjusted difference in remission rates|9.9||||0.1415||95.0|-4.47|23.13||p-value has not been adjusted for multiplicity|Cochran-Mantel-Haenszel|||||23.13|-4.47|0.1415
72389094|NCT02165215|144286396|SUPERIORITY||Difference in Least Square Means|-2.8||||0.0266|TWO_SIDED|95.0|-5.3|-0.4||p-value has not been adjusted for multiplicity|Cochran-Mantel-Haenszel|||||-0.4|-5.3|0.0266
72389095|NCT02165215|144286397|SUPERIORITY||Difference in Least Square Means|-1.2||||0.0175|TWO_SIDED|95.0|-2.2|-0.2||p-value has not been adjusted for multiplicity|Cochran-Mantel-Haenszel|||||-0.2|-2.2|0.0175
72389096|NCT02165215|144286398|SUPERIORITY||Difference in Adjusted Mean|2.1||||0.6331|TWO_SIDED|95.0|-6.6|10.8||p-value has not been adjusted for multiplicity|ANCOVA|||||10.8|-6.6|0.6331
72389097|NCT01948947|144286412|OTHER||||||<|0.0001|||||||ANOVA|||Change from Baseline to 1-Week Post-Treatment||||<0.0001
72389098|NCT01948947|144286412|OTHER||||||<|0.001|||||||ANOVA|||Change from Baseline to 1-Month Post-Treatment||||<0.001
72389099|NCT01948947|144286413|OTHER||||||<|0.001||||||Change from Baseline to 1-Week post-treatment|ANOVA|||||||<0.001
72389100|NCT01948947|144286413|OTHER||||||<|0.01||||||Change from Baseline to 1-Month post-treatment|ANOVA|||||||<0.01
72389101|NCT01948947|144286414|OTHER|||||||0.009|||||||ANOVA|||||||0.009
72389102|NCT01948947|144286414|OTHER||||||<|0.01||||||Change in Baseline to 1-month post-treatment|ANOVA|||||||<0.01
72389103|NCT01948947|144286415|OTHER||||||=|0.033|||||||ANOVA|||||||=0.033
72389104|NCT05096221|144286416|SUPERIORITY||Least squares mean change difference|0.65|STANDARD_ERROR_OF_MEAN|0.55||0.2441|TWO_SIDED|95.0|-0.45|1.74|||Mixed model of repeated measures|||||1.74|-0.45|0.2441
72389105|NCT05096221|144286417|OTHER||||||<|0.0001|||||||Re-randomization test|||||||< 0.0001
72389106|NCT05096221|144286418|SUPERIORITY||Least squares mean change difference|-0.64|STANDARD_ERROR_OF_MEAN|0.21||0.0025|TWO_SIDED|95.0|-1.06|-0.23|||Mixed model of repeated measures|||||-0.23|-1.06|0.0025
72389107|NCT05096221|144286419|SUPERIORITY||Least squares mean change difference|-0.42|STANDARD_ERROR_OF_MEAN|0.15||0.0048|TWO_SIDED|95.0|-0.71|-0.13|||Mixed model of repeated measures|||||-0.13|-0.71|0.0048
72389108|NCT05096221|144286420|SUPERIORITY||Least squares mean change difference|-3.29|STANDARD_ERROR_OF_MEAN|2.52||0.1942|TWO_SIDED|95.0|-8.28|1.7|||Mixed model of repeated measures|||||1.70|-8.28|0.1942
72389109|NCT05096221|144286421|SUPERIORITY||Least squares mean change difference|-0.36|STANDARD_ERROR_OF_MEAN|0.18||0.0412|TWO_SIDED|95.0|-0.71|-0.01|||Mixed model of repeated measures|||||-0.01|-0.71|0.0412
72389110|NCT05096221|144286422|SUPERIORITY||Least squares mean change difference|0.1|STANDARD_ERROR_OF_MEAN|0.05||0.0402|TWO_SIDED|95.0|0.0|0.19|||Mixed model of repeated measures|||||0.19|0.00|0.0402
72389111|NCT05096221|144286423|SUPERIORITY||Least squares mean change difference|0.05|STANDARD_ERROR_OF_MEAN|0.07||0.4272|TWO_SIDED|95.0|-0.08|0.19|||Mixed model of repeated measures|||||0.19|-0.08|0.4272
72389112|NCT05096221|144286424|SUPERIORITY||Least squares mean change difference|-0.04|STANDARD_ERROR_OF_MEAN|0.1||0.7324|TWO_SIDED|95.0|-0.24|0.17|||Mixed model of repeated measures|||||0.17|-0.24|0.7324
72389113|NCT05096221|144286425|SUPERIORITY||Least squares mean change difference|0.19|STANDARD_ERROR_OF_MEAN|0.44||0.6554|TWO_SIDED|95.0|-0.67|1.06|||Mixed model of repeated measures|||||1.06|-0.67|0.6554
72389114|NCT04645953|144286432|SUPERIORITY|||||||0.7024|||||||ANOVA|||Null hypothesis is there was no difference between groups treated with AZ-010 (1 mg or 3 mg) and the placebo group in the mean number of vomiting/retching events in the 2 hours following. treatment. Baseline, body weight, height, body mass index, age as covariates, and the treatment group and study site as factors. All statistical tests were 2-sided with a significance value of ≤ 0.05.||||0.7024
72389115|NCT04645953|144286432|SUPERIORITY|Null hypothesis is there was no difference between groups treated with AZ-010 (1 mg or 3 mg) and the placebo group in the mean number of vomiting/retching events in the 2 hours following. treatment. Baseline, body weight, height, body mass index, age as covariates, and the treatment group and study site as factors. Patients summarized by actual treatment received. Formal statistical tests (ANOVA, when performed) were 2-sided t-tests with a significance value of 0.05.||||||0.2051|||||||ANOVA|||||||0.2051
72497288|NCT02613208|144524378|OTHER|Correlation analysis|Spearman coefficient|0.392|||<|0.001|||||||Spearman's correlation analysis|||Correlation between CTC and CEA level considering baseline CTC count||||<0.001
72389116|NCT04645953|144286433|SUPERIORITY|||||||0.0504|||||||Mixed Models Analysis|||Participants were asked to rate their anxiety/panic on scale of 0-100 at each time point. The higher the number, the more intense the symptom.||||0.0504
72389117|NCT04645953|144286433|SUPERIORITY|Participants were asked to rate their anxiety/panic on scale of 0-100 at each time point. The higher the number, the more intense the symptom.||||||0.8246|||||||Mixed Models Analysis|||||||0.8246
72389118|NCT04645953|144286434|SUPERIORITY|||||||0.8299||||||Prior Episode Duration 1mg AZ-010|Mixed Models Analysis|||||||0.8299
72389119|NCT04645953|144286434|SUPERIORITY|||||||0.2346||||||Prior Episode Duration 3 mg AZ-010|Mixed Models Analysis|||||||0.2346
72389120|NCT04645953|144286434|SUPERIORITY|||||||0.3997||||||Prior Episode intensity 1mg AZ-010|Mixed Models Analysis|||||||0.3997
72389121|NCT04645953|144286434|SUPERIORITY|||||||0.3997||||||Prior Episode intensity 3mg AZ-010|Mixed Models Analysis|||||||0.3997
72444456|NCT02187003|144403228|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.7944|TWO_SIDED|95.0|0.77|1.22|||Log Rank|||A Cox proportional hazards regression model with age group and genotype group as stratification covariates was used to estimate the hazard ratio (Placebo/Rivipansel) and the corresponding 95 percent (%) confidence interval (CI). A stratified log-rank test with age group and genotype group as stratification variables was performed to evaluate P value.||1.22|0.77|0.7944
72444457|NCT02187003|144403229|SUPERIORITY||Hazard Ratio (HR)|0.96||||0.7156|TWO_SIDED|95.0|0.77|1.19|||Log Rank|||A Cox proportional hazards regression model with age group and genotype group as stratification covariates was used to estimate the hazard ratio (Placebo/Rivipansel) and the corresponding 95% CI. A stratified log-rank test with age group and genotype group as stratification variables was performed to evaluate P- value.||1.19|0.77|0.7156
72497289|NCT02613208|144524378|OTHER|Correlation analysis|Spearman coefficient|0.088||||0.444|||||||Spearman's correlation analysis|||Correlation between CTC and CEA level considering CTC count at cycle 2||||0.444
72497290|NCT02613208|144524380|OTHER|Correlation analysis|Spearman coefficient|0.373|||<|0.001|||||||Spearman's correlation analysis|||Correlation between CTC and CA 15.3 level considering baseline CTC count||||<0.001
72497291|NCT02613208|144524380|OTHER|Correlation analysis|Spearman coefficient|0.129||||0.241|||||||Spearman's correlation analysis|||Correlation between CTC and CA 15.3 level considering CTC count at cycle 2||||0.241
72389122|NCT04645953|144286435|SUPERIORITY|||||||0.3847|||||||Mantel Haenszel|||||||0.3847
72389123|NCT04645953|144286435|SUPERIORITY|||||||0.1785|||||||Mantel Haenszel|||||||0.1785
72389124|NCT04645953|144286436|SUPERIORITY|||||||0.9732|||||||Mantel Haenszel|||||||0.9732
72389125|NCT04645953|144286436|SUPERIORITY|||||||0.1471|||||||Mantel Haenszel|||||||0.1471
72389126|NCT04645953|144286437|SUPERIORITY|||||||0.1337|||||||ANOVA|||The RINVR is an 8-part questionnaire with each item scored from 0-4, for a total scoring range of 0-32. A lower score indicates less distress related to nausea, vomiting, and retching. The data shown is collected within the first 24 hours after the first at-home dose.||||0.1337
72389127|NCT04645953|144286437|SUPERIORITY|||||||0.7224|||||||ANOVA|||||||0.7224
72389128|NCT04645953|144286438|SUPERIORITY|||||||0.0504|||||||Mixed Models Analysis|||Participants were asked to rate their abdominal pain, nausea, and anxiety/panic on scale of 0-100 at each time point. The higher the number, the more intense the symptom.||||0.0504
72389129|NCT04645953|144286438|SUPERIORITY|||||||0.8246|||||||Mixed Models Analysis|||||||0.8246
72389130|NCT04645953|144286439|SUPERIORITY|||||||0.9664|||||||Mixed Models Analysis|||||||0.9664
72389131|NCT04645953|144286439|SUPERIORITY|||||||0.7919|||||||Mixed Models Analysis|||||||0.7919
72389132|NCT04613375|144286440|OTHER||Adjusted VE|16.91||||0.3685|TWO_SIDED|95.0|-24.43|44.52|||Wald Test||Adjusted for the covariates age group, weekly exposure to children less than 5 years, calendar time, and CAP with respiratory syncytial virus (RSV) infection.|||44.52|-24.43|0.3685
72389133|NCT04613375|144286441|OTHER||Adjusted VE|49.27||||0.0817|TWO_SIDED|95.0|-8.9|76.37|||Wald Test||Adjusted for the covariates age group, weekly exposure to children less than 5 years, calendar time, and CAP with RSV infection.|\<2 years||76.37|-8.9|0.0817
72389134|NCT04613375|144286441|OTHER||Adjusted VE|4.72||||0.8367|TWO_SIDED|95.0|-50.96|39.87|||Wald Test||Adjusted for the covariates age group, weekly exposure to children less than 5 years, calendar time, and CAP with RSV infection.|2 years to \<5 years||39.87|-50.96|0.8367
72389135|NCT04613375|144286441|OTHER||Adjusted VE|12.02||||0.7469|TWO_SIDED|95.0|-91.53|59.59|||Wald Test||Adjusted for the covariates age group, weekly exposure to children less than 5 years, calendar time, and CAP with RSV infection.|\>=5 years||59.59|-91.53|0.7469
72389136|NCT04613375|144286447|OTHER||Adjusted VE|25.96||||0.1827|TWO_SIDED|95.0|-15.21|52.42|||Wald Test||Adjusted for the covariates age group, weekly exposure to children less than 5 years, calendar time, and CAP with RSV infection.|||52.42|-15.21|0.1827
72389137|NCT04613375|144286448|OTHER||Adjusted VE|68.86||||0.028|TWO_SIDED|95.0|11.86|89.0|||Wald Test||Adjusted for the covariates age group, weekly exposure to children less than 5 years, calendar time, and CAP with RSV infection.|\<2 years||89|11.86|0.028
72389138|NCT04613375|144286448|OTHER||Adjusted VE|7.97||||0.738|TWO_SIDED|95.0|-49.73|43.43|||Wald Test||Adjusted for the covariates age group, weekly exposure to children less than 5 years, calendar time, and CAP with RSV infection.|2 years to \<5 years||43.43|-49.73|0.738
72389139|NCT04613375|144286448|OTHER||Adjusted VE|30.06||||0.4327|TWO_SIDED|95.0|-70.86|71.37|||Wald Test||Adjusted for the covariates age group, weekly exposure to children less than 5 years, calendar time, and CAP with RSV infection.|\>=5 years||71.37|-70.86|0.4327
72389140|NCT02527161|144286466|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
72389141|NCT02527161|144286467|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||Change from preoperative to 6 weeks KOOS Pain||||<0.0001
72389142|NCT02527161|144286467|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0013|||||||ANOVA|||Change from 6 weeks to 3 months KOOS Pain||||0.0013
72389143|NCT02527161|144286467|SUPERIORITY|||||||0.3316|||||||ANOVA|||Change from 3 months to 6 months KOOS Pain||||0.3316
72389144|NCT02527161|144286467|SUPERIORITY|||||||0.3366|||||||ANOVA|||Change from 6 months to 1 year KOOS Pain||||0.3366
72389145|NCT02527161|144286467|SUPERIORITY|||||||0.9826|||||||ANOVA|||Change from 1 year to 2 year KOOS Pain||||0.9826
72389146|NCT02527161|144286467|SUPERIORITY|||||||0.9276|||||||ANOVA|||Change from 2 year to 5 year KOOS Pain||||0.9276
72389147|NCT02527161|144286468|SUPERIORITY||||||<|0.0001|||||||ANOVA|||Change from preoperative to 6 weeks KOOS Symptoms||||<0.0001
72389148|NCT02527161|144286468|SUPERIORITY|||||||0.0736|||||||ANOVA|||Change from 6 weeks to 3 months KOOS Symptoms||||0.0736
72389149|NCT02527161|144286468|SUPERIORITY|||||||0.4675|||||||ANOVA|||Change from 3 months to 6 months KOOS Symptoms||||0.4675
72389150|NCT02527161|144286468|SUPERIORITY|||||||0.0229|||||||ANOVA|||Change from 6 months to 1 year KOOS Symptoms||||0.0229
72389151|NCT02527161|144286468|SUPERIORITY|||||||0.9968|||||||ANOVA|||Change from 1 year to 2 year KOOS Symptoms||||0.9968
72389152|NCT02527161|144286468|SUPERIORITY|||||||0.7761|||||||ANOVA|||Change from 2 year to 5 year KOOS Symptoms||||0.7761
72389153|NCT02527161|144286469|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||Change from preoperative to 6 weeks KOOS ADL||||<0.0001
72389154|NCT02527161|144286469|SUPERIORITY|||||||0.0212|||||||ANOVA|||Change from 6 weeks to 3 months KOOS ADL||||0.0212
72560310|NCT02377349|144651191|SUPERIORITY|Criterion: The lower limit (LL) of the 95% confidence interval (CI) of the GMC ratio \[dTpa Group-Mother/Control Group-Mother\] for anti-PT antibodies was greater than or equal to (≥) 1.5.|GMC ratio|8.47|||||TWO_SIDED|95.0|7.02|10.2|||2-sample t-test|The CI of the group GMC ratio were computed using two-sample t-test assuming heterogeneity of variance.||GMC ratio between groups (dTpa Group-Mother/Control Group-Mother) to demonstrate that maternally transferred antibodies against pertussis in the dTpa Group-Mother was superior to that in the Control Group-mother, in the cord blood sample at the time of delivery.||10.2|7.02|
72560311|NCT02377349|144651191|SUPERIORITY|Criterion: The lower limit (LL) of the 95% confidence interval (CI) of the GMC ratio \[dTpa Group-Mother/Control Group-Mother\] for anti-FHA antibodies was greater than or equal to (≥) 1.5.|GMC ratio|16.11|||||TWO_SIDED|95.0|13.48|19.24|||2-sample t-test|The CI of the group GMC ratio were computed using two-sample t-test assuming heterogeneity of variance.||GMC ratio between groups (dTpa Group-Mother/Control Group-Mother) to demonstrate that maternally transferred antibodies against pertussis in the dTpa Group-Mother was superior to that in the Control Group-mother, in the cord blood sample at the time of delivery.||19.24|13.48|
72560312|NCT02377349|144651191|SUPERIORITY|Criterion: The lower limit (LL) of the 95% confidence interval (CI) of the GMC ratio \[dTpa Group-Mother/Control Group-Mother\] for anti-PRN antibodies was greater than or equal to (≥) 1.5.|GMC ratio|20.65|||||TWO_SIDED|95.0|15.86|26.88|||2-sample t-test|The CI of the group GMC ratio were computed using two-sample t-test assuming heterogeneity of variance.||GMC ratio between groups (dTpa Group-Mother/Control Group-Mother) to demonstrate that maternally transferred antibodies against pertussis in the dTpa Group-Mother was superior to that in the Control Group-mother, in the cord blood sample at the time of delivery.||26.88|15.86|
72560313|NCT00021541|144651217|SUPERIORITY|||||||0.012|||||||Repeated measures ANOVA|||||||0.012
72560314|NCT00021541|144651217|OTHER|||||||0.015|||||||Repeated measures ANOVA|||Post hoc test: tipifarnib group F=7.40||||0.015
72560315|NCT00021541|144651217|OTHER|||||||0.66|||||||Repeated measures ANOVA|||Post hoc test: placebo group F=0.19||||0.66
72619205|NCT01655069|144769068|OTHER||Adjusted change from baseline|2.69|STANDARD_ERROR_OF_MEAN|0.69|||TWO_SIDED|95.0|1.34|4.05|||Repeated Measures ANCOVA|Duration of solifenacin treatment: 12 weeks||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant."||4.05|1.34|
72560316|NCT03828539|144651221|OTHER||Odds Ratio (OR)|0.19|||<|0.001|TWO_SIDED|95.0|0.13|0.27|||Regression, Logistic|Odds ratio is obtained from a logistic regression model that includes treatment group and stratification factor (MMD at baseline)||||0.27|0.13|<.001
72560317|NCT03828539|144651222|OTHER||Odds Ratio (OR)|2.76|||<|0.001|TWO_SIDED|95.0|2.06|3.71|||Regression, Logistic|Odds ratio is obtained from a logistic regression model that includes treatment group and stratification factor (MMD at baseline)||||3.71|2.06|<.001
72560318|NCT03828539|144651223|OTHER||Odds Ratio (OR)|2.3|||<|0.001|TWO_SIDED|95.0|1.7|3.12|||Regression, Logistic|Odds ratio is obtained from a logistic regression model that includes treatment group and stratification factor (MMD at baseline)||||3.12|1.70|<.001
72619206|NCT01655069|144769068|OTHER||Adjusted change from baseline|3.07|STANDARD_ERROR_OF_MEAN|0.69|||TWO_SIDED|95.0|1.7|4.43|||Repeated Measures ANCOVA|Duration of solifenacin treatment: 24 weeks||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant."||4.43|1.70|
72619207|NCT01655069|144769068|OTHER||Adjusted change from baseline|2.45|STANDARD_ERROR_OF_MEAN|0.71|||TWO_SIDED|95.0|1.05|3.85|||Repeated Measures ANCOVA|Duration of solifenacin treatment: 40 weeks||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant."||3.85|1.05|
72560319|NCT03828539|144651224|OTHER||Odds Ratio (OR)|1.75|||<|0.001|TWO_SIDED|95.0|1.26|2.43|||Regression, Logistic|Odds ratio is obtained from a logistic regression model that includes treatment group and stratification factor (MMD at baseline)||Physical Component Summary (PCS)||2.43|1.26|<0.001
72560320|NCT03828539|144651224|OTHER||Odds Ratio (OR)|1.79||||0.005|TWO_SIDED|95.0|1.29|2.69|||Regression, Logistic|Odds ratio is obtained from a logistic regression model that includes treatment group and stratification factor (MMD at baseline)||Mental Component Summary (MCS)||2.69|1.29|0.005
72389155|NCT02527161|144286469|SUPERIORITY|||||||0.7173|||||||ANOVA|||Change from 3 months to 6 months KOOS ADL||||0.7173
72389156|NCT02527161|144286469|SUPERIORITY|||||||0.1834|||||||ANOVA|||Change from 6 months to 1 year KOOS ADL||||0.1834
72389157|NCT02527161|144286469|SUPERIORITY|||||||0.9957|||||||ANOVA|||Change from 1 year to 2 year KOOS ADL||||0.9957
72389158|NCT02527161|144286469|SUPERIORITY|||||||0.9999|||||||ANOVA|||Change from 6 months to 1 year KOOS ADL||||0.9999
72389159|NCT02527161|144286470|SUPERIORITY||||||<|0.0001|||||||ANOVA|||Change from preoperative to 6 weeks KOOS S\&R||||<0.0001
72389160|NCT02527161|144286470|SUPERIORITY|||||||0.0522|||||||ANOVA|||Change from 6 weeks to 3 months KOOS S\&R||||0.0522
72389161|NCT02527161|144286470|SUPERIORITY|||||||0.1696|||||||ANOVA|||Change from 3 months to 6 months KOOS S\&R||||0.1696
72389162|NCT02527161|144286470|SUPERIORITY|||||||0.6942|||||||ANOVA|||Change from 6 months to 1 year KOOS S\&R||||0.6942
72389163|NCT02527161|144286470|SUPERIORITY||||||>|0.9999|||||||ANOVA|||Change from 1 year to 2 year KOOS S\&R||||>0.9999
72389164|NCT02527161|144286470|SUPERIORITY||||||>|0.9999|||||||ANOVA|||Change from 2 year to 5 year KOOS S\&R||||>0.9999
72389165|NCT02527161|144286471|SUPERIORITY||||||<|0.0001|||||||ANOVA|||Change from preoperative to 6 weeks KOOS QoL||||<0.0001
72389166|NCT02527161|144286471|SUPERIORITY|||||||0.0135|||||||ANOVA|||Change from 6 weeks to 3 months KOOS QoL||||0.0135
72389167|NCT02527161|144286471|SUPERIORITY|||||||0.0829|||||||ANOVA|||Change from 3 months to 6 months KOOS QoL||||0.0829
72389168|NCT02527161|144286471|SUPERIORITY|||||||0.1729|||||||ANOVA|||Change from 6 months to 1 year KOOS QoL||||0.1729
72389169|NCT02527161|144286471|SUPERIORITY|||||||0.9687|||||||ANOVA|||Change from 1 year to 2 year KOOS QoL||||0.9687
72389170|NCT02527161|144286471|SUPERIORITY||||||>|0.9999|||||||ANOVA|||Change from 2 year to 5 year KOOS QoL||||>0.9999
72444458|NCT02187003|144403230|SUPERIORITY||Mean Difference (Net)|-0.06||||0.852|TWO_SIDED|95.0|-1.27|0.88|||ANCOVA|||The difference in medians (Rivipansel- Placebo) was estimated by the difference of treatment medians from summary statistics. The corresponding 95% CI was estimated by a bootstrap method with stratification for age and genotype groups. P-value was from analysis of covariance (ANCOVA) model based on rank-transformed values using age group and genotype group as the stratification covariates.||0.88|-1.27|0.8520
72444459|NCT02187003|144403231|SUPERIORITY||Hazard Ratio (HR)|1.02||||0.8593|TWO_SIDED|95.0|0.82|1.26|||Log Rank|||A Cox proportional hazards regression model with age group and genotype group as stratification covariates was used to estimate the hazard ratio (Placebo/Rivipansel) and the corresponding 95% CI. A stratified log-rank test with age group and genotype group as stratification variables was performed to evaluate P- value.||1.26|0.82|0.8593
72444460|NCT02187003|144403232|SUPERIORITY||Median Difference (Final Values)|-0.02||||0.9332|TWO_SIDED|95.0|-0.13|0.16|||ANCOVA|||The difference in medians (Rivipansel- Placebo) was estimated by the difference of treatment medians from summary statistics. The corresponding 95% CI was estimated by a bootstrap method with stratification for age and genotype groups. P value was from ANCOVA model based on rank-transformed values using age group and genotype group as the stratification covariates.||0.16|-0.13|0.9332
72444461|NCT02187003|144403233|SUPERIORITY||Difference in percentage of participants|-1.17||||0.5349|TWO_SIDED|95.0|-5.19|2.46|||Chan and Zhang|||P values and 95% CI for the difference in percentages were based on the exact method by Chan and Zhang.||2.46|-5.19|0.5349
72444462|NCT02187003|144403240|SUPERIORITY||Risk Difference (RD)|-3.336||||0.302|TWO_SIDED|95.0|-10.024|2.968|||Chan and Zhang|||||2.968|-10.024|0.3020
72444463|NCT02187003|144403241|SUPERIORITY||Risk Difference (RD)|1.203||||0.5429|TWO_SIDED|95.0|-2.379|5.104|||Chan and Zhang|||||5.104|-2.379|0.5429
72444464|NCT04172441|144403253|SUPERIORITY||Difference in LS means|-5.21||||0.0037|TWO_SIDED|95.0|-8.29|-2.13|||Mixed Models Analysis|A mixed model was used, with treatment and period as fixed effects and patient as random effect.|The comparison was in the direction of dasiglucagon minus placebo.|Null hypothesis: weighted mean IV GIR in the last 12 hours of treatment with dasiglucagon = weighted mean IV GIR in the last 12 hours of treatment with placebo||-2.13|-8.29|0.0037
72444465|NCT04172441|144403254|SUPERIORITY||Difference in LS means|-30.93||||0.0238|TWO_SIDED|95.0|-56.8|-5.05|||Mixed Models Analysis|A mixed model was used, with treatment and period as fixed effects and patient as random effect.|The comparison was in the direction of dasiglucagon minus placebo.|Null hypothesis: Total amount of carbohydrates administered (regardless of route) per day in patients treated with dasiglucagon = total amount of carbohydrates administered (regardless of route) per day in patients treated with placebo||-5.05|-56.80|0.0238
72444466|NCT04674358|144403278|SUPERIORITY||Odds Ratio (OR)|2.63|||||TWO_SIDED|95.0|1.67|4.14||||||||4.14|1.67|
72444467|NCT00676715|144403327|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||Van Elteren Test (stratified)|||Van Elteren test is stratified by region and presence of baseline gadolinium-enhancing lesions (absent or present).||||<0.0001
72444468|NCT00676715|144403327|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||Van Elteren Test (stratified)|||Van Elteren test is stratified by region and presence of baseline gadolinium-enhancing lesions (absent or present).||||<0.0001
72560321|NCT03201003|144651267|SUPERIORITY||Risk Difference (RD)|56.0|||<|0.0001|TWO_SIDED|95.0|44.1|65.2|||Fisher Exact|||Treatment difference at 1000 mg||65.2|44.1|<0.0001
72444469|NCT00676715|144403327|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7496|||||||Van Elteren Test (stratified)|||Van Elteren test is stratified by region and presence of baseline gadolinium-enhancing lesions (absent or present).||||0.7496
72444470|NCT00676715|144403328|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0019|||||||Poisson model|||Poisson model was fitted for adjusting for geographic region only.||||0.0019
72444471|NCT00676715|144403328|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0136|||||||Poisson model|||Poisson model was fitted for adjusting for geographic region only.||||0.0136
72444472|NCT00676715|144403328|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1814|||||||Poisson model|||Poisson model was fitted for adjusting for geographic region only.||||0.1814
72444473|NCT00676715|144403329|SUPERIORITY_OR_OTHER_LEGACY||Relative risk (RR)|0.6||||0.1978|TWO_SIDED|95.0|0.27|1.34|||Cochran-Mantel-Haenszel chi-square test|Cochran-Mantel-Haenszel (CMH) chi-square test stratified by geographical region only.||||1.34|0.27|0.1978
72444474|NCT00676715|144403329|SUPERIORITY_OR_OTHER_LEGACY||Relative risk (RR)|0.53||||0.131|TWO_SIDED|95.0|0.23|1.22|||CMH chi-square test|CMH chi-square test stratified by geographical region only.||||1.22|0.23|0.1310
72560322|NCT03201003|144651268|SUPERIORITY||Risk Difference (RD)|58.9|||<|0.0001|TWO_SIDED|95.0|44.2|69.3|||Fisher Exact|||Treatment difference at 600 mg||69.3|44.2|<0.0001
72444475|NCT00676715|144403329|SUPERIORITY_OR_OTHER_LEGACY||Relative risk (RR)|0.92||||0.8206|TWO_SIDED|95.0|0.46|1.84|||CMH chi-square tes|CMH chi-square test stratified by geographical region only.||||1.84|0.46|0.8206
72444476|NCT00676715|144403330|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1391|||||||Van Elteren Test (stratified)|Van Elteren test is stratified by region only.||||||0.1391
72444477|NCT00676715|144403330|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1596|||||||Van Elteren Test (stratified)|Van Elteren test is stratified by region only.||||||0.1596
72444478|NCT00676715|144403330|SUPERIORITY_OR_OTHER_LEGACY|||||||0.474|||||||Van Elteren Test (stratified)|Van Elteren test is stratified by region only.||||||0.4740
72444479|NCT00676715|144403331|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||Van Elteren Test (stratified)|Van Elteren test is stratified by region only.||||||<0.0001
72444480|NCT00676715|144403331|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||Van Elteren Test (stratified)|Van Elteren test is stratified by region only.||||||<0.0001
72444481|NCT00676715|144403331|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4985|||||||Van Elteren Test (stratified)|Van Elteren test is stratified by region only.||||||0.4985
72560323|NCT03201003|144651269|SUPERIORITY||Risk Difference (RD)|57.2|||<|0.0001|TWO_SIDED|95.0|41.2|69.1|||Fisher Exact|||Treatment difference at 300 mg||69.1|41.2|<0.0001
72560324|NCT03201003|144651270|SUPERIORITY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel statistic (with equally spaced scores) stratified by country||Treatment difference in Maximum Severity||||<0.0001
72560325|NCT00834613|144651271|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|103.45||||||90.0|99.87|107.15|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||107.15|99.87|
72444482|NCT00676715|144403332|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0004|||||||Van Elteren Test (stratified)|Van Elteren test is stratified by region only.||||||0.0004
72444483|NCT00676715|144403332|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||Van Elteren Test (stratified)|Van Elteren test is stratified by region only.||||||<0.0001
72444484|NCT00676715|144403332|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2725|||||||Van Elteren Test (stratified)|Van Elteren test is stratified by region only.||||||0.2725
72389171|NCT02527161|144286472|SUPERIORITY||||||<|0.0001|||||||ANOVA|||Change from preoperative to 6 weeks SF-12 PCS||||<0.0001
72389172|NCT02527161|144286472|SUPERIORITY||||||<|0.0001|||||||ANOVA|||Change from 6 weeks to 3 months SF-12 PCS||||<0.0001
72389173|NCT02527161|144286472|SUPERIORITY|||||||0.8189|||||||ANOVA|||Change from 3 months to 6 months SF-12 PCS||||0.8189
72389174|NCT02527161|144286472|SUPERIORITY|||||||0.9845|||||||ANOVA|||Change from 6 months to 1 year SF-12 PCS||||0.9845
72389175|NCT02527161|144286472|SUPERIORITY|||||||0.75|||||||ANOVA|||Change from 1 year to 2 year SF-12 PCS||||0.7500
72389176|NCT02527161|144286472|SUPERIORITY|||||||0.1376|||||||ANOVA|||Change from 2 year to 5 year SF-12 PCS||||0.1376
72389177|NCT02527161|144286473|SUPERIORITY||||||<|0.0001|||||||ANOVA|||Change from preoperative to 6 week VAS Rest||||<0.0001
72389178|NCT02527161|144286473|SUPERIORITY|||||||0.0031|||||||ANOVA|||Change from 6 weeks to 3 months VAS Rest||||0.0031
72389179|NCT02527161|144286473|SUPERIORITY|||||||0.299|||||||ANOVA|||Change from 3 months to 6 months VAS Rest||||0.2990
72389180|NCT02527161|144286473|SUPERIORITY|||||||0.9832|||||||ANOVA|||Change from 6 months to 1 year VAS Rest||||0.9832
72389181|NCT02527161|144286473|SUPERIORITY|||||||0.9991|||||||ANOVA|||Change from 1 year to 2 year VAS Rest||||0.9991
72389182|NCT02527161|144286473|SUPERIORITY||||||>|0.9999|||||||ANOVA|||Change from 2 year to 5 year VAS Rest||||>0.9999
72389183|NCT02527161|144286474|SUPERIORITY||||||<|0.0001|||||||ANOVA|||Change from preoperative to 6 weeks VAS Mob||||<0.0001
72389184|NCT02527161|144286474|SUPERIORITY|||||||0.0062|||||||ANOVA|||Change from 6 weeks to 3 months VAS Mob||||0.0062
72389185|NCT02527161|144286474|SUPERIORITY|||||||0.373|||||||ANOVA|||Change from 3 months to 6 months VAS Mob||||0.3730
72389186|NCT02527161|144286474|SUPERIORITY|||||||0.8499|||||||ANOVA|||Change from 6 months to 1 year VAS Mob||||0.8499
72389187|NCT02527161|144286474|SUPERIORITY||||||>|0.9999|||||||ANOVA|||Change from 1 year to 2 year VAS Mob||||>0.9999
72389188|NCT02527161|144286474|SUPERIORITY|||||||0.9958|||||||ANOVA|||Change from 2 year to 5 year VAS Mob||||0.9958
72389189|NCT02527161|144286475|SUPERIORITY|||||||0.3493|||||||ANOVA|||Change from preoperative to 6 weeks SF-12 MCS||||0.3493
72389190|NCT02527161|144286475|SUPERIORITY|||||||0.48|||||||ANOVA|||Change from 6 weeks to 3 months SF-12 MCS||||0.4800
72389191|NCT02527161|144286475|SUPERIORITY||||||>|0.9999|||||||ANOVA|||Change from 3 months to 6 months SF-12 MCS||||>0.9999
72389192|NCT02527161|144286475|SUPERIORITY||||||>|0.9999|||||||ANOVA|||Change from 6 months to 1 year SF-12 MCS||||>0.9999
72389193|NCT02527161|144286475|SUPERIORITY||||||>|0.9999|||||||ANOVA|||Change from 1 year to 2 year SF-12 MCS||||>0.9999
72389194|NCT02527161|144286475|SUPERIORITY||||||>|0.9999|||||||ANOVA|||Change from 2 year to 5 year SF-12 MCS||||>0.9999
72389195|NCT02527161|144286476|SUPERIORITY||||||<|0.0001|||||||ANOVA|||Change from preoperative to 6 weeks KSS Pain||||<0.0001
72389196|NCT02527161|144286476|SUPERIORITY|||||||0.9465|||||||ANOVA|||Change from 3 months to 6 months KSS Pain||||0.9465
72389197|NCT02527161|144286476|SUPERIORITY|||||||0.1215|||||||ANOVA|||Change from 6 months to 1 year KSS Pain||||0.1215
72389198|NCT02527161|144286476|SUPERIORITY|||||||0.9912|||||||ANOVA|||Change from 1 year to 2 years KSS Pain||||0.9912
72389199|NCT02527161|144286476|SUPERIORITY|||||||0.8952|||||||ANOVA|||Change from 2 year to 5 year KSS Pain||||0.8952
72389200|NCT02527161|144286477|SUPERIORITY||||||<|0.0001|||||||ANOVA|||Change from preoperative to 3 months KSS Function||||<0.0001
72389201|NCT02527161|144286477|SUPERIORITY|||||||0.0266|||||||ANOVA|||Change from 3 months to 6 months KSS Function||||0.0266
72389202|NCT02527161|144286477|SUPERIORITY|||||||0.988|||||||ANOVA|||Change from 6 months to 1 year KSS Function||||0.9880
72389203|NCT02527161|144286477|SUPERIORITY|||||||0.9699|||||||ANOVA|||Change from 1 year to 2 years KSS Function||||0.9699
72389204|NCT02527161|144286477|SUPERIORITY|||||||0.8575|||||||ANOVA|||Change from 2 year to 5 years KSS Function||||0.8575
72389205|NCT02527161|144286478|SUPERIORITY|||||||0.8581|||||||ANOVA|||Change from preoperative to 3 months KSS Range of Motion||||0.8581
72389206|NCT02527161|144286478|SUPERIORITY|||||||0.7664|||||||ANOVA|||Change from 3 months to 6 months KSS Range of Motion||||0.7664
72389207|NCT02527161|144286478|SUPERIORITY|||||||0.7022|||||||ANOVA|||Change from 6 months to 1 year KSS Range of Motion||||0.7022
72389208|NCT02527161|144286478|SUPERIORITY||||||>|0.9999|||||||ANOVA|||Change from 1 year to 2 year KSS Range of Motion||||>0.9999
72389209|NCT02527161|144286478|SUPERIORITY|||||||0.2943|||||||ANOVA|||Change from 2 year to 5 year KSS Range of Motion||||0.2943
72389210|NCT02527161|144286479|SUPERIORITY|||||||0.0161|||||||ANOVA|||Change from 1 year to 2 year Forgotten Joint Score||||0.0161
72389211|NCT02527161|144286479|SUPERIORITY||||||<|0.0001|||||||ANOVA|||Change from 2 year to 5 year Forgotten Joint Score||||<0.0001
72389212|NCT00724932|144286493|SUPERIORITY_OR_OTHER||Geometric Mean Ratio (Final Values)|3.4|||<|0.0001|TWO_SIDED|95.0|2.8|4.1||Testing was performed using a two-sided test at the 0.05 significance level. There was only one primary comparison, therefore no adjustment for multiplicity was required.|ANOVA||Sugammadex is the numerator and neostigmine the denominator. The estimated value for the geometric mean ratio presents how many times the geometric mean time to recovery of the T4/T1 ratio to 0.9 was faster with sugammadex compared to neostigmine.|To evaluate the efficacy of sugammadex compared to neostigmine, the ratio of the geometric means of time to recovery of the T4/T1 ratio to 0.9 was calculated using a two-way analysis of variance (ANOVA) model adjusted for treatment group and trial site.||4.1|2.8|<0.0001
72389213|NCT00724932|144286494|SUPERIORITY_OR_OTHER||Geometric Mean Ratio (Final Values)|2.5|||<|0.0001|TWO_SIDED|95.0|2.1|2.8||The p-value is not adjusted for multiplicity.|ANOVA||Sugammadex is the numerator and neostigmine the denominator. The estimated value for the geometric mean ratio presents how many times the geometric mean time to recovery of the T4/T1 ratio to 0.7 was faster with sugammadex compared to neostigmine.|To evaluate the efficacy of sugammadex compared to neostigmine, the ratio of the geometric means of time to recovery of the T4/T1 ratio to 0.7 was calculated using a two-way ANOVA model adjusted for treatment group and trial site.||2.8|2.1|<0.0001
72444485|NCT01820260|144403334|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0002|TWO_SIDED|||||To account for multiple testing, the 4 pairwise tests with corresponding vehicle group were performed using Bonferroni method testing at a 1.25% significance level, securing that the overall significance level did not exceed 5%|Fisher Exact|||Complete clearance of AKs at Week 8 was to be analysed by log binomial regression with factors treatment group, anatomical location (face/chest or scalp) and analysis site. Due to the low numbers of subjects obtaining complete clearance in the vehicle groups,the proposed model did not converge and Fisher's exact test was used instead to compare active treatments with the respective vehicle arm.||||0.0002
72444486|NCT01820260|144403334|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0037|TWO_SIDED|||||see comments in analysis 1|Fisher Exact|||See comment in analysis 1||||0.0037
72444487|NCT01820260|144403334|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0171|TWO_SIDED|||||See comments in analysis 1|Fisher Exact|||See comments in analysis 1||||0.0171
72444488|NCT01820260|144403334|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0001|TWO_SIDED||||||Fisher Exact|||||||0.0001
72444489|NCT01820260|144403335|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||z-test|||To account for multiple testing among the secondary endpoints, a hierarchical order of testing was determined, where the following evaluation was done separately for each of the four active groups: Provided the primary endpoint was significant at a 1.25% level, the comparison to vehicle in terms of reduction in AK count from baseline to week 8 was tested at a 1.25% level. Provided this test was significant, the second secondary endpoint,partial clearance, was tested(vs. vehicle) at a 1.25% level||||< 0.001
72444490|NCT01820260|144403335|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||z-test|||See comment in analysis 1||||< 0.001
72444491|NCT01820260|144403335|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||z-test|||See comment analysis 1||||< 0.001
72444492|NCT01820260|144403335|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||z-test|||See comment in analysis 1||||< 0.001
72444493|NCT01820260|144403336|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Fisher Exact|||Analysis of partial clearance of AK's at Week 8 was done in the same way as for the primary outcome (endpoint)||||<0.001
72444494|NCT01820260|144403336|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Fisher Exact|||||||< 0.001
72444495|NCT01820260|144403336|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Fisher Exact|||||||< 0.001
72444496|NCT01820260|144403336|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Fisher Exact|||||||< 0.001
72444497|NCT02991534|144403353|SUPERIORITY||Odds Ratio (OR)|1.09||||0.003|TWO_SIDED|95.0|1.03|1.152|||Non-linear model with Logit|Non-linear model with Logit Link Function with Robust Standard Errors||||1.152|1.030|.003
72444498|NCT02991534|144403354|SUPERIORITY||Odds Ratio (OR)|1.0||||0.91|TWO_SIDED|95.0|0.976|1.022|||Non-linear model with Logit|Non-linear model with Logit Link Function with Robust Standard Errors||||1.022|0.976|0.91
72444499|NCT02991534|144403355|SUPERIORITY||Odds Ratio (OR)|1.06||||0.265|TWO_SIDED|95.0|0.959|1.165|||Non-linear model with Logit|Non-linear model with Logit Link Function with Robust Standard Errors||||1.165|.959|.265
72560326|NCT00834613|144651272|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|97.63||||||90.0|95.21|100.11|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||100.11|95.21|
72560327|NCT00834613|144651273|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|97.63||||||90.0|95.22|100.1|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||100.1|95.22|
72619208|NCT01655069|144769068|OTHER||Adjusted change from baseline|3.93|STANDARD_ERROR_OF_MEAN|0.81|||TWO_SIDED|95.0|2.34|5.53|||Repeated Measures ANCOVA|Duration of solifenacin treatment: 52 weeks||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant."||5.53|2.34|
72444500|NCT02991534|144403356|SUPERIORITY||Odds Ratio (OR)|1.01||||0.015|TWO_SIDED|95.0|1.002|1.022|||Non-linear model with Logit|Non-linear model with Logit Link Function with Robust Standard Errors||||1.022|1.002|0.015
72444501|NCT01889199|144403423|OTHER||Mean Difference (Final Values)|1.12||||0.004|TWO_SIDED|||||a priori threshold p\<0.05|t-test, 2 sided|||Only PCOS women were randomized to flutamide versus placebo; controls were not randomized A sample size of 11 per group (PCOS women versus controls) provided adequate power (approximately 80%) to detect effect sizes as small as 1.25 using a two-sample t-test (alpha=0.05, 2 tailed). A sample size of 5 per group (flutamide-treated versus placebo-treated PCOS women) also gave adequate power (approximately 80%) to detect effect sizes as small as 2 using a two-sample t-test (alpha=0.05, 2 tailed).||||0.004
72444502|NCT01889199|144403424|OTHER||Mean Difference (Net)|0.024|||||TWO_SIDED|||||||||6-month changes from baseline were compared between placebo- and flutamide-treated PCOS women using an unpaired Student's t-test to determine whether one group changed more than the other over this time interval.||||
72444503|NCT01889199|144403426|OTHER||Mean Difference (Net)|0.04||||0.04|TWO_SIDED||||||t-test, 2 sided|||6-month changes from baseline were compared between placebo- and flutamide-treated PCOS women using an unpaired Student's t-test to determine whether one group changed more than the other over this time interval.||||0.040
72444504|NCT01889199|144403427|OTHER|||||||0.034|||||||t-test, 2 sided|||6-month changes from baseline were compared between placebo- and flutamide-treated PCOS women using an unpaired Student's t-test to determine whether one group changed more than the other over this time interval.||||0.034
72444505|NCT00220740|144403430|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||The primary efficacy endpoint was the comparison of the Responder rates in the ITT population. Treatment group differences were tested by a Chi-square test. Subjects who did not complete the 24 week Efficacy Period and entered Rescue treatment with the alternative treatment were counted as Nonresponders.||||<0.001
72444506|NCT00220740|144403431|SUPERIORITY_OR_OTHER|||||||0.542|TWO_SIDED||||||ANCOVA|||||||0.542
72444507|NCT00220740|144403432|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Dominant hand||||<0.001
72444508|NCT00220740|144403432|SUPERIORITY_OR_OTHER|||||||0.005|TWO_SIDED||||||ANCOVA|||Non-dominant hand||||0.005
72444509|NCT02814838|144403496|SUPERIORITY||Mean Difference (Final Values)|0.14||||0.3303|TWO_SIDED|95.0|-0.14|0.42|||Student's t test for unpaired samples|||Transformed AUC was analyzed with Student t-test for unpaired data using PROC TTEST within SAS® to compare Ladarixin and placebo groups. The estimated treatment difference between Ladarixin and placebo was also presented together with the corresponding 95% confidence interval.||0.42|-0.14|0.3303
72444510|NCT02814838|144403497|SUPERIORITY|The comparisons between groups on 2-hour AUC C-peptide efficacy endpoint was carried-out using a mixed linear model where the log(x+1) transformed 2-hour AUC C-peptide was the dependent variable, while treatment group, visit, treatment by visit interaction were the fixed factors of the model and patient will be the random effect. An unstructured covariance matrix for each patient is considered and the Kenward-Roger adjustment is used for the degrees of freedom.|adjusted mean difference|0.0984||||0.517|TWO_SIDED|95.0|-0.2028|0.3995|||Mixed Models Analysis|||at FUP week 26||0.3995|-0.2028|0.517
72444511|NCT02814838|144403497|SUPERIORITY|The comparisons between groups on 2-hour AUC C-peptide efficacy endpoint was carried-out using a mixed linear model where the log(x+1) transformed 2-hour AUC C-peptide was the dependent variable, while treatment group, visit, treatment by visit interaction were the fixed factors of the model and patient will be the random effect. An unstructured covariance matrix for each patient is considered and the Kenward-Roger adjustment is used for the degrees of freedom.|adjusted mean difference|-0.0486||||0.7999|TWO_SIDED|95.0|-0.4294|0.3322|||Mixed Models Analysis|||At FUP week 52||0.3322|-0.4294|0.7999
72444512|NCT02814838|144403498|SUPERIORITY||adjusted mean difference|12.0411||||0.2224|TWO_SIDED|95.0|-7.3823|31.4644|||Mixed Models Analysis|||at week 13||31.4644|-7.3823|0.2224
72444513|NCT02814838|144403498|SUPERIORITY||adjusted mean difference|8.4803||||0.3931|TWO_SIDED|95.0|-11.0935|28.0541|||Mixed Models Analysis|||At week 26||28.0541|-11.0935|0.3931
72444514|NCT02814838|144403498|SUPERIORITY||adjusted mean difference|-2.9502||||0.7664|TWO_SIDED|95.0|-22.5476|16.6473|||Mixed Models Analysis|||At week 52||16.6473|-22.5476|0.7664
72444515|NCT02814838|144403499|SUPERIORITY|Analysis is based on a linear mixed model for repeated measures with Daily Insulin Requirement (IU/kg/day) as dependent variable, treatment, visit and treatment by visit interaction as fixed effects and patient as random effect.|adjusted mean difference|-0.048||||0.2225|TWO_SIDED|95.0|-0.1257|0.0298|||Mixed Models Analysis|||at week 13||0.0298|-0.1257|0.2225
72444516|NCT02814838|144403499|SUPERIORITY|Analysis is based on a linear mixed model for repeated measures with Daily Insulin Requirement (IU/kg/day) as dependent variable, treatment, visit and treatment by visit interaction as fixed effects and patient as random effect.|adjusted mean difference|-0.0369||||0.551|TWO_SIDED|95.0|-0.1596|0.0858|||Mixed Models Analysis|||at week 26||0.0858|-0.1596|0.551
72444517|NCT02814838|144403499|SUPERIORITY|Analysis is based on a linear mixed model for repeated measures with Daily Insulin Requirement (IU/kg/day) as dependent variable, treatment, visit and treatment by visit interaction as fixed effects and patient as random effect.|adjusted mean difference|-0.063||||0.2501|TWO_SIDED|95.0|-0.1712|0.0453|||Mixed Models Analysis|||at week 52||0.0453|-0.1712|0.2501
72444518|NCT02814838|144403500|SUPERIORITY|Analysis is based on a linear mixed model for repeated measures with HbA1c (%) as dependent variable, treatment, visit and treatment by visit interaction as fixed effects and patient as random effect.|adjusted mean difference|-0.1494||||0.6252|TWO_SIDED|95.0|-0.7514|0.4526|||Mixed Models Analysis|||at FU week 13||0.4526|-0.7514|0.6252
72444519|NCT02814838|144403500|SUPERIORITY|Analysis is based on a linear mixed model for repeated measures with HbA1c (%) as dependent variable, treatment, visit and treatment by visit interaction as fixed effects and patient as random effect.|adjusted mean difference|-0.2804||||0.366|TWO_SIDED|95.0|-0.8904|0.3297|||Mixed Models Analysis|||At FU week 26||0.3297|-0.8904|0.366
72444520|NCT02814838|144403500|SUPERIORITY|Analysis is based on a linear mixed model for repeated measures with HbA1c (%) as dependent variable, treatment, visit and treatment by visit interaction as fixed effects and patient as random effect.|adjusted mean difference|-0.2063||||0.5026|TWO_SIDED|95.0|-0.3992|0.8118|||Mixed Models Analysis|||At FU week 52||0.8118|-0.3992|0.5026
72444521|NCT02814838|144403501|SUPERIORITY|Analysis is based on a linear mixed model for repeated measures with C-peptide (nmol/L) actual value as dependent variable, treatment, visit, time, treatment by visit interaction, time by visit interaction, treatment by visit by time interaction as fixed effects and time by visit interaction is specified in repeated statement.|adjusted mean difference|0.0242||||0.2527|TWO_SIDED|95.0|-0.0174|0.0658|||Mixed Models Analysis|||at week 13||0.0658|-0.0174|0.2527
72444522|NCT02814838|144403501|SUPERIORITY|Analysis is based on a linear mixed model for repeated measures with C-peptide (nmol/L) actual value as dependent variable, treatment, visit, time, treatment by visit interaction, time by visit interaction, treatment by visit by time interaction as fixed effects and time by visit interaction is specified in repeated statement.|adjusted mean difference|0.0236||||0.2743|TWO_SIDED|95.0|-0.0188|0.066|||Mixed Models Analysis|||at week 26||0.066|-0.0188|0.2743
72560328|NCT00697619|144651283|SUPERIORITY_OR_OTHER|||||||0.37||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.370
72560329|NCT00697619|144651283|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.001
72560330|NCT00697619|144651283|SUPERIORITY_OR_OTHER||||||<|0.01||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.01
72560331|NCT03930849|144651307|OTHER||F-value for Type 3 Fixed, df=4|2.01||||0.1|TWO_SIDED||||||Mixed Models Analysis|P-value is for F-value reported below of group x time term in a mixed methods analysis.||||||0.10
72560332|NCT03930849|144651308|SUPERIORITY||F statistic GroupxTime, df=4|0.025||||0.9|TWO_SIDED||||||Mixed Models Analysis|P-value is for F-value reported below of group x time analysis in a mixed methods analysis.||||||0.90
72560333|NCT03930849|144651309|SUPERIORITY||F Value Group x Time, DF=4|2.12||||0.08|TWO_SIDED|||||P-value of F statistic reported below for mixed methods analysis group\*time interaction term.|Mixed Models Analysis|||||||0.08
72560334|NCT01251393|144651316|EQUIVALENCE|"The comparisons between the placebo and the biperiden groups at baseline were performed by means of the independent t-Test. We evaluated the normality (Kolmogorov's test) and homogeneity (Levene's test) of the sample.~We used an ANOVA for repeated measures, followed by Bonferroni's post-hoc test to evaluate the efficacy of biperiden in reducing consumption of cocaine/crack."|||||<|0.05||||||We used an ANOVA for repeated measures, followed by Bonferroni's post-hoc test to evaluate the efficacy of biperiden in reducing consumption of cocaine/crack.|ANOVA|||We evaluated the normality (Kolmogorov's test) and homogeneity (Levene's test) of the sample.||||<0.05
72444523|NCT02814838|144403501|SUPERIORITY|Analysis is based on a linear mixed model for repeated measures with C-peptide (nmol/L) actual value as dependent variable, treatment, visit, time, treatment by visit interaction, time by visit interaction, treatment by visit by time interaction as fixed effects and time by visit interaction is specified in repeated statement.|adjusted mean difference|-0.0059||||0.7856|TWO_SIDED|95.0|-0.0485|0.0367|||Mixed Models Analysis|||at week 52||0.0367|-0.0485|0.7856
72444524|NCT02814838|144403502|SUPERIORITY|Analysis is based on a linear mixed model for repeated measures with Glucose (mmol/L) actual value as dependent variable, treatment, visit, time, treatment by visit interaction, time by visit interaction, treatment by visit by time interaction as fixed effects and time by visit interaction is specified in repeated statement.|adjusted mean difference|-0.0253||||0.9307|TWO_SIDED|95.0|-0.5986|0.548|||Mixed Models Analysis|||at week 13||0.548|-0.5986|0.9307
72444525|NCT02814838|144403502|SUPERIORITY|Analysis is based on a linear mixed model for repeated measures with Glucose (mmol/L) actual value as dependent variable, treatment, visit, time, treatment by visit interaction, time by visit interaction, treatment by visit by time interaction as fixed effects and time by visit interaction is specified in repeated statement.|adjusted mean difference|-0.7236||||0.0139|TWO_SIDED|95.0|-1.2989|-0.1483|||Mixed Models Analysis|||At week 26||-0.1483|-1.2989|0.0139
72444526|NCT02814838|144403502|SUPERIORITY|Analysis is based on a linear mixed model for repeated measures with Glucose (mmol/L) actual value as dependent variable, treatment, visit, time, treatment by visit interaction, time by visit interaction, treatment by visit by time interaction as fixed effects and time by visit interaction is specified in repeated statement.|adjusted mean difference|-0.5979||||0.0432|TWO_SIDED|95.0|-1.1775|-0.0184|||Mixed Models Analysis|||at week 52||-0.0184|-1.1775|0.0432
72444527|NCT02814838|144403504|SUPERIORITY|||||||0.1171|||||||Fisher Exact|||at week 13||||0.1171
72444528|NCT02814838|144403504|SUPERIORITY|||||||0.6586|||||||Fisher Exact|||At week 26||||0.6586
72444529|NCT02814838|144403504|SUPERIORITY|||||||0.5056|||||||Fisher Exact|||At week 52||||0.5056
72444530|NCT02814838|144403505|SUPERIORITY|||||||0.0779|||||||Fisher Exact|||at week 13||||0.0779
72444531|NCT02814838|144403505|SUPERIORITY|||||||0.0248|||||||Fisher Exact|||At week 26||||0.0248
72444532|NCT02814838|144403505|SUPERIORITY|||||||0.4504|||||||Fisher Exact|||At week 52||||0.4504
72444533|NCT02814838|144403506|SUPERIORITY|Analysis is based on a linear mixed model for repeated measures with log(AUC(15-120 minutes)+1) of C-peptide above fasting value as dependent variable, treatment, visit and treatment by visit interaction as fixed effects and patient as random effect.|adjusted mean difference|0.1402||||0.4163|TWO_SIDED|95.0|-0.2015|0.4819|||Mixed Models Analysis|||At week 13||0.4819|-0.2015|0.4163
72560335|NCT03086135|144651317|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||PTA4 at 3 months with the Osia system vs Unaided at visit 1||||<0.0001
72619209|NCT01655069|144769069|OTHER||Adjusted change from baseline|-0.98|STANDARD_ERROR_OF_MEAN|0.15|||TWO_SIDED|95.0|-1.27|-0.69|||Repeated Measures ANCOVA|Duration of solifenacin treatment: 3 weeks||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant."||-0.69|-1.27|
72619210|NCT01655069|144769069|OTHER||Adjusted change from baseline|-1.15|STANDARD_ERROR_OF_MEAN|0.15|||TWO_SIDED|95.0|-1.44|-0.86|||Repeated Measures ANCOVA|Duration of solifenacin treatment: 6 weeks||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant"||-0.86|-1.44|
72619211|NCT01655069|144769069|OTHER||Adjusted change from baseline|-1.31|STANDARD_ERROR_OF_MEAN|0.15|||TWO_SIDED|95.0|-1.6|-1.02|||Repeated Measures ANCOVA|Duration of solifenacin treatment: 9 weeks||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant"||-1.02|-1.60|
72560336|NCT03086135|144651318|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Speech in noise at 3 months with the Osia system vs Unaided at visit 1||||<0.0001
72444534|NCT02814838|144403506|SUPERIORITY|Analysis is based on a linear mixed model for repeated measures with log(AUC(15-120 minutes)+1) of C-peptide above fasting value as dependent variable, treatment, visit and treatment by visit interaction as fixed effects and patient as random effect.|adjusted mean difference|0.177||||0.3575|TWO_SIDED|95.0|-0.2039|0.558|||Mixed Models Analysis|||At week 26||0.558|-0.2039|0.3575
72444535|NCT02814838|144403506|SUPERIORITY|Analysis is based on a linear mixed model for repeated measures with log(AUC(15-120 minutes)+1) of C-peptide above fasting value as dependent variable, treatment, visit and treatment by visit interaction as fixed effects and patient as random effect.|adjusted mean difference|0.0451||||0.8386|TWO_SIDED|95.0|-0.3948|0.4851|||Mixed Models Analysis|||At week 52||0.4851|-0.3948|0.8386
72444536|NCT02814838|144403507|SUPERIORITY|Transformed AUC was analyzed with Student t-test for unpaired data using PROC TTEST within SAS® to compare Ladarixin and placebo groups. The estimated treatment difference between Ladarixin and placebo was also presented together with the corresponding 95% confidence interval.|Mean Difference (Final Values)|0.354|||=|0.1114|TWO_SIDED|95.0|-0.09|0.75|||t-test, 2 sided|||At week 13||0.75|-0.09|= 0.1114
72444537|NCT02814838|144403507|SUPERIORITY|Transformed AUC was analyzed with Student t-test for unpaired data using PROC TTEST within SAS® to compare Ladarixin and placebo groups. The estimated treatment difference between Ladarixin and placebo was also presented together with the corresponding 95% confidence interval.|Mean Difference (Final Values)|0.502|||=|0.0411|TWO_SIDED|95.0|0.02|0.98|||t-test, 2 sided|||At week 26||0.98|0.02|= 0.0411
72560337|NCT03086135|144651319|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||PTA4 at 4 weeks with the Osia system vs Unaided at visit 1.||||<0.0001
72560338|NCT03086135|144651319|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||PTA4 at 6 months with the Osia system vs Unaided at visit 1.||||<0.0001
72560339|NCT03086135|144651319|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||PTA4 at 12 months with the Osia system vs Unaided at visit 1.||||<0.0001
72560340|NCT03086135|144651320|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Threshold audiometry 250Hz at 4 weeks with the Osia system vs Unaided at visit 1.||||<0.0001
72444538|NCT02814838|144403507|SUPERIORITY|Transformed AUC was analyzed with Student t-test for unpaired data using PROC TTEST within SAS® to compare Ladarixin and placebo groups. The estimated treatment difference between Ladarixin and placebo was also presented together with the corresponding 95% confidence interval.|Mean Difference (Final Values)|0.223|||=|0.4506|TWO_SIDED|95.0|-0.37|0.82|||t-test, 2 sided|||At week 52||0.82|-0.37|= 0.4506
72444539|NCT02814838|144403508|SUPERIORITY||Adjusted mean difference|0.3631||||0.1847|TWO_SIDED|95.0|-0.1817|0.908|||Mixed Models Analysis|||Week 13 Analysis is based on a linear mixed model for repeated measures with log(AUC(15-120 minutes)+1) of C-peptide above fasting value as dependent variable, treatment, visit and treatment by visit interaction||0.908|-0.1817|0.1847
72444540|NCT02814838|144403508|SUPERIORITY||Adjusted mean difference|0.6304||||0.031|TWO_SIDED|95.0|0.0609|1.1998|||Mixed Models Analysis|||Week 26 Analysis is based on a linear mixed model for repeated measures with log(AUC(15-120 minutes)+1) of C-peptide above fasting value as dependent variable, treatment, visit and treatment by visit interaction||1.1998|0.0609|0.031
72444541|NCT02814838|144403508|SUPERIORITY||Adjusted mean difference|0.1639||||0.6299|TWO_SIDED|95.0|-0.5202|0.8479|||Mixed Models Analysis|||Week 52 Analysis is based on a linear mixed model for repeated measures with log(AUC(15-120 minutes)+1) of C-peptide above fasting value as dependent variable, treatment, visit and treatment by visit interaction||0.8479|-0.5202|0.6299
72444542|NCT02814838|144403509|SUPERIORITY|||||||0.163|||||||Fisher Exact|||Week 13||||0.163
72444543|NCT02814838|144403509|SUPERIORITY|||||||0.0074|||||||Fisher Exact|||Week 26||||0.0074
72444544|NCT02814838|144403509|SUPERIORITY|||||||0.4437|||||||Fisher Exact|||Week 52||||0.4437
72444545|NCT03811366|144403510|OTHER||||||<|0.001||||||significance when p\<0;05|generalized estimated equation|generalized estimated equation with normal distribution and logarithmic link function||||||<0.001
72444546|NCT03811366|144403513|OTHER|||||||0.054||||||significance when p\<0.05|Fisher Exact|||Recurrence or worsening of cells in anterior chamber in ERG-stable and ERG worsening group.||||0.054
72444547|NCT03811366|144403514|OTHER|||||||0.478||||||17 eyes presented dark dots fluctuation during follow up in stable ERG group when compared to 5 eyes in worsening ERG group.|generalized estimated equation|Generalized estimated equation with Poisson distribution and identity link function supposing an interchangeable correlation matrix between the eyes||||||0.478
72444548|NCT03811366|144403516|OTHER|9 (52.9%) eyes in ERG stable group x 4 (57.1%)eyes presented change in perivascular leakage during follow up (p=0.936).||||||0.936|||||||Generalized estimated equation|Generalized estimated equation with binomial distribution and logit link function, supposing an interchangeable correlation matrix between the eyes;||Change in perivascular leakage in ERG-stable and ERG- worsening groups.||||0.936
72444549|NCT03811366|144403517|OTHER|||||||0.853||||||significance when p\<0.05|Generalized estimated equation|Generalized estimated equation with binomial distribution and logit link function, supposing an interchangeable correlation matrix between the eyes;||||||0.853
72444550|NCT03811366|144403518|OTHER|||||||0.272||||||significance when p\<0.05|Fisher Exact|||||||0.272
72444551|NCT03811366|144403519|OTHER|||||||0.983||||||significance when p\<0.05|Generalized estimated equation with bino|Generalized estimated equation with binomial distribution and logit link function, supposing an interchangeable correlation matrix between the eyes||||||0.983
72444552|NCT02596126|144403525|NON_INFERIORITY|"Non-inferiority hypothesis will be tested using a univariable Cox PH regression model including treatment group as the only covariate and stratified by country.~One-sided non-inferiority test on the primary endpoint where the alpha level will be set to 2.5%.~All statistical analyses will use 95% confidence intervals (CI). If the non-inferiority hypothesis is confirmed, it will be followed with a test of superiority using a log-rank test."|Hazard Ratio (HR)|0.76|||<|0.025|TWO_SIDED|95.0|0.6|0.96|||Regression, Cox|||||0.96|0.6|< 0.025
72444553|NCT02596126|144403525|SUPERIORITY|If the non-inferiority hypothesis is confirmed, it will be followed with a test of superiority using a logrank test.|||||<|0.05|||||||Log Rank|||||||< 0.05
72444554|NCT02596126|144403526|EQUIVALENCE|Treatment adherence is measured at visit 1 (6 months) and visit 3 (24 months) using the Morisky-Medication Adherence Scale (8 item) Questionnaire (MMAS-8). The number and percentage of patients with low (0-5), medium (6-7) and high (8) adherence will be reported by treatment group. The distributions of the MMAS-8 score at 6 months and 24 months will be compared between treatment groups using an ordinal logistic regression model.|Risk Ratio (RR)|1.13|||<|0.005|TWO_SIDED|95.0|1.06|1.2|||Chi-squared|||Statistical analysis title - Treatment adherence at 6 months||1.2|1.06|< 0.005
72444555|NCT02596126|144403527|SUPERIORITY|Time to first event will be investigated using Cox proportional hazards regression. Hazard ratios and 95% confidence intervals will be obtained from the Cox proportional hazards model. P-values will be obtained using the log-rank test.|Hazard Ratio (HR)|0.97|||<|0.05|TWO_SIDED|95.0|0.75|1.25|||Log Rank|||Statistical analysis title - All-cause death||1.25|0.75|< 0.05
72444556|NCT02596126|144403528|EQUIVALENCE|Treatment adherence is measured at visit 1 (6 months) and visit 3 (24 months) using the Morisky- Medication Adherence Scale (8 item) Questionnaire (MMAS-8). The number and percentage of patients with low (0-5), medium (6-7) and high(8) adherence will be reported by treatment group. The distributions of the MMAS-8 score at 6 months and 24 months will be compared between treatment groups using an ordinal logistic regression model.|Hazard Ratio (HR)|1.17|||<|0.005|TWO_SIDED|95.0|1.1|1.25|||Chi-squared|||Statistical analysis title - Treatment adherence at 24 months||1.25|1.1|< 0.005
72560341|NCT03086135|144651320|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Threshold audiometry at 500Hz at 4 weeks with the Osia system vs Unaided at visit 1.||||<0.0001
72560342|NCT03086135|144651320|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Threshold audiometry at 750Hz at 4 weeks with the Osia system vs Unaided at visit 1.||||<0.0001
72560343|NCT03086135|144651320|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Threshold audiometry at 1000Hz at 4 weeks with the Osia system vs Unaided at visit 1.||||<0.0001
72560344|NCT03086135|144651320|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Threshold audiometry at 1500Hz at 4 weeks with the Osia system vs Unaided at visit 1.||||<0.0001
72560345|NCT03086135|144651320|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Threshold audiometry at 2000Hz at 4 weeks with the Osia system vs Unaided at visit 1.||||<0.0001
72560346|NCT03086135|144651320|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Threshold audiometry at 3000Hz at 4 weeks with the Osia system vs Unaided at visit 1.||||<0.0001
72619212|NCT01655069|144769069|OTHER||Adjusted change from baseline|-1.22|STANDARD_ERROR_OF_MEAN|0.15|||TWO_SIDED|95.0|-1.51|-0.93|||Repeated Measures ANCOVA|Duration of solifenacin treatment: 12 weeks||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant"||-0.93|-1.51|
72619213|NCT01655069|144769069|OTHER||Adjusted change from baseline|-1.5|STANDARD_ERROR_OF_MEAN|0.15|||TWO_SIDED|95.0|-1.8|-1.21|||Repeated Measures ANCOVA|Duration of solifenacin treatment: 24 weeks||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant."||-1.21|-1.80|
72389214|NCT00724932|144286502|SUPERIORITY_OR_OTHER||Geometric Mean Ratio (Final Values)|2.9|||<|0.0001|TWO_SIDED|95.0|2.5|3.4||The p-value is not adjusted for multiplicity.|ANOVA||Sugammadex is the numerator and neostigmine the denominator. The estimated value for the geometric mean ratio presents how many times the geometric mean time to recovery of the T4/T1 ratio to 0.8 was faster with sugammadex compared to neostigmine.|To evaluate the efficacy of sugammadex compared to neostigmine, the ratio of the geometric means of time to recovery of the T4/T1 ratio to 0.8 was calculated using a two-way ANOVA model adjusted for treatment group and trial site.||3.4|2.5|<0.0001
72389215|NCT01081678|144286528|OTHER|||||||0.1983|||||||F-test|The p-value is based on F-test of multi-linear contrasts at Week 6 through Week 20.||The primary analysis was based on a test for linear trend in dose response at weeks 6, 12, 16, and 20. To account for multiple comparisons over time points, the primary analysis used a size α = 0.05 F-test with 4 degrees of freedom for the contrasts at Weeks 6, 12, 16, and 20.||||0.1983
72389216|NCT01517711|144286534|SUPERIORITY_OR_OTHER_LEGACY|||||||0.286||||||P value is for overall post-randomization CAPS score|ANOVA|||Women were excluded from analysis because of the small sample size and unequal distribution across groups.||||0.286
72389217|NCT01517711|144286535|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.1|||||||ANOVA|||||||<0.10
72389218|NCT01517711|144286536|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.03|||||||ANOVA|||Analysis is for sleep only (men)||||=0.03
72389219|NCT02499783|144286541|SUPERIORITY||Adjusted Risk Difference|30.4|||<|0.001|TWO_SIDED|95.0|19.2|41.7|||Cochran-Mantel-Haenszel|Stratified by Crohn's disease severity (CDAI \<= 300 and CDAI \>300) at baseline and corticosteroid use at baseline.|Risk difference = (adalimumab 160/80 mg - placebo). Stratified by Crohn's disease severity (CDAI \<= 300 and CDAI \>300) at baseline and corticosteroid use at baseline.|||41.7|19.2|<0.001
72389220|NCT02499783|144286542|SUPERIORITY||Risk Difference Compared to 30%|34.6|||<|0.001|TWO_SIDED|95.0|26.2|42.4|||One Sample Exact Test|The one sample Exact test was performed by comparing it to the clinically meaningful remission rate of 30%.||||42.4|26.2|< 0.001
72389221|NCT02499783|144286543|SUPERIORITY||Adjusted Risk Difference|33.4|||<|0.001|TWO_SIDED|95.0|23.2|43.6||Based on Cochran-Mantel-Haenszel test stratified by be stratified by Crohn's disease severity (CDAI \<= 300, \> 300) at Baseline and corticosteroid use at Baseline.|Cochran-Mantel-Haenszel||Risk difference = (adalimumab 160/80 mg - placebo). Based on Cochran-Mantel-Haenszel test stratified by be stratified by Crohn's disease severity (CDAI \<= 300, \> 300) at Baseline and corticosteroid use at Baseline.|||43.6|23.2|< 0.001
72444557|NCT02596126|144403529|EQUIVALENCE|The following three CV risk factors, systolic blood pressure(SBP), diastolic blood pressure (DBP) and low-density lipoprotein (LDL) cholesterol levels are measured at baseline, visit 1 (6 months), visit 2 (12 months) and visit 3 (24 months).For each of the three risk factors the frequency, mean and standard deviation at each visit will be reported by treatment group. The difference in mean change from baseline between groups will be compared using ANCOVA.|Mean Difference (Final Values)|-0.3|||<|0.05|TWO_SIDED|95.0|-1.8|1.2||The difference in mean change from baseline between groups will be compared using ANCOVA (adjusting for baseline levels) at 6 months, 12 months and 24 months. The difference in mean change adjusting for baseline and 95% CI will be reported.|ANCOVA|||Statistical analysis title - SBP - 6 months||1.2|-1.8|< 0.05
72444558|NCT02596126|144403530|EQUIVALENCE|The following three CV risk factors, systolic blood pressure(SBP), diastolic blood pressure (DBP) and low-density lipoprotein (LDL) cholesterol levels are measured at baseline, visit 1 (6 months), visit 2 (12 months) and visit 3 (24 months).For each of the three risk factors the frequency, mean and standard deviation at each visit will be reported by treatment group. The difference in mean change from baseline between groups will be compared using ANCOVA.|Mean Difference (Final Values)|1.4|||<|0.05|TWO_SIDED|95.0|-0.1|3.0||The difference in mean change from baseline between groups will be compared using ANCOVA (adjusting for baseline levels) at 6 months, 12 months and 24 months. The difference in mean change adjusting for baseline and 95% CI will be reported.|ANCOVA|||Statistical analysis title - SBP - 12 months||3|-0.1|< 0.05
72444559|NCT02596126|144403531|EQUIVALENCE|The following three CV risk factors, systolic blood pressure(SBP), diastolic blood pressure (DBP) and low-density lipoprotein (LDL) cholesterol levels are measured at baseline, visit 1 (6 months), visit 2 (12 months) and visit 3 (24 months).For each of the three risk factors the frequency, mean and standard deviation at each visit will be reported by treatment group. The difference in mean change from baseline between groups will be compared using ANCOVA.|Mean Difference (Final Values)|-0.1|||<|0.05|TWO_SIDED|95.0|-1.7|1.4||The difference in mean change from baseline between groups will be compared using ANCOVA (adjusting for baseline levels) at 6 months, 12 months and 24 months. The difference in mean change adjusting for baseline and 95% CI will be reported.|ANCOVA|||Statistical analysis title - SBP - 24 months||1.4|-1.7|< 0.05
72444560|NCT02596126|144403532|EQUIVALENCE|The following three CV risk factors, systolic blood pressure(SBP), diastolic blood pressure (DBP) and low-density lipoprotein (LDL) cholesterol levels are measured at baseline, visit 1 (6 months), visit 2 (12 months) and visit 3 (24 months).For each of the three risk factors the frequency, mean and standard deviation at each visit will be reported by treatment group. The difference in mean change from baseline between groups will be compared using ANCOVA.|Mean Difference (Final Values)|0.2|||<|0.05|TWO_SIDED|95.0|-0.7|1.0||The difference in mean change from baseline between groups will be compared using ANCOVA (adjusting for baseline levels) at 6 months, 12 months and 24 months. The difference in mean change adjusting for baseline and 95% CI will be reported.|ANCOVA|||Statistical analysis title - DBP - 6 months||1|-0.7|< 0.05
72444561|NCT02596126|144403533|EQUIVALENCE|The following three CV risk factors, systolic blood pressure(SBP), diastolic blood pressure (DBP) and low-density lipoprotein (LDL) cholesterol levels are measured at baseline, visit 1 (6 months), visit 2 (12 months) and visit 3 (24 months).For each of the three risk factors the frequency, mean and standard deviation at each visit will be reported by treatment group. The difference in mean change from baseline between groups will be compared using ANCOVA.|Mean Difference (Final Values)|0.8|||<|0.05|TWO_SIDED|95.0|-0.1|1.6||The difference in mean change from baseline between groups will be compared using ANCOVA (adjusting for baseline levels) at 6 months, 12 months and 24 months. The difference in mean change adjusting for baseline and 95% CI will be reported.|ANCOVA|||Statistical analysis title - DBP - 12 months||1.6|-0.1|< 0.05
72444562|NCT02596126|144403534|EQUIVALENCE|The following three CV risk factors, systolic blood pressure(SBP), diastolic blood pressure (DBP) and low-density lipoprotein (LDL) cholesterol levels are measured at baseline, visit 1 (6 months), visit 2 (12 months) and visit 3 (24 months).For each of the three risk factors the frequency, mean and standard deviation at each visit will be reported by treatment group. The difference in mean change from baseline between groups will be compared using ANCOVA.|Mean Difference (Final Values)|0.0|||<|0.05|TWO_SIDED|95.0|-0.9|1.0||The difference in mean change from baseline between groups will be compared using ANCOVA (adjusting for baseline levels) at 6 months, 12 months and 24 months. The difference in mean change adjusting for baseline and 95% CI will be reported.|ANCOVA|||Statistical analysis title - DBP - 24 months||1|-0.9|< 0.05
72444563|NCT02596126|144403535|EQUIVALENCE|The following three CV risk factors, systolic blood pressure(SBP), diastolic blood pressure (DBP) and low-density lipoprotein (LDL) cholesterol levels are measured at baseline, visit 1 (6 months), visit 2 (12 months) and visit 3 (24 months).For each of the three risk factors the frequency, mean and standard deviation at each visit will be reported by treatment group. The difference in mean change from baseline between groups will be compared using ANCOVA.|Mean Difference (Final Values)|2.1|||<|0.05|TWO_SIDED|95.0|-0.2|4.4|||ANCOVA|||Statistical analysis title - LDL cholesterol - 12 months||4.4|-0.2|< 0.05
72444564|NCT02596126|144403536|EQUIVALENCE|The following three CV risk factors, systolic blood pressure(SBP), diastolic blood pressure (DBP) and low-density lipoprotein (LDL) cholesterol levels are measured at baseline, visit 1 (6 months), visit 2 (12 months) and visit 3 (24 months).For each of the three risk factors the frequency, mean and standard deviation at each visit will be reported by treatment group. The difference in mean change from baseline between groups will be compared using ANCOVA.|Mean Difference (Final Values)|-0.1|||<|0.05|TWO_SIDED|95.0|-2.5|2.4|||ANCOVA|||Statistical analysis title - LDL cholesterol - 24 months||2.4|-2.5|< 0.05
72444565|NCT02596126|144403537|NON_INFERIORITY|"Non-inferiority hypothesis will be tested using a univariable Cox PH regression model including treatment group as the only covariate and stratified by country.~One-sided non-inferiority test on the primary endpoint where the alpha level will be set to 2.5%.~All statistical analyses will use 95% confidence intervals (CI).If the non-inferiority hypothesis is confirmed, it will be followed with a test of superiority using a log-rank test."|Hazard Ratio (HR)|0.7|||<|0.025|TWO_SIDED|95.0|0.54|0.9|||Regression, Cox|||||0.90|0.54|< 0.025
72444566|NCT02596126|144403537|SUPERIORITY|If the non-inferiority hypothesis is confirmed, it will be followed with a test of superiority using a logrank test.|||||<|0.05|||||||Log Rank|||||||< 0.05
72444567|NCT02596126|144403538|NON_INFERIORITY|"Non-inferiority hypothesis will be tested using a univariable Cox PH regression model including treatment group as the only covariate and stratified by country.~One-sided non-inferiority test on the primary endpoint where the alpha level will be set to 2.5%.~All statistical analyses will use 95% confidence intervals (CI).If the non-inferiority hypothesis is confirmed, it will be followed with a test of superiority using a log-rank test."|Hazard Ratio (HR)|0.67|||<|0.025|TWO_SIDED|95.0|0.47|0.97|||Regression, Cox|||||0.97|0.47|< 0.025
72444568|NCT02596126|144403538|SUPERIORITY|If the non-inferiority hypothesis is confirmed, it will be followed with a test of superiority using a logrank test.|||||<|0.05|||||||Log Rank|||||||< 0.05
72444569|NCT02596126|144403539|NON_INFERIORITY|"Non-inferiority hypothesis will be tested using a univariable Cox PH regression model including treatment group as the only covariate and stratified by country.~One-sided non-inferiority test on the primary endpoint where the alpha level will be set to 2.5%.~All statistical analyses will use 95% confidence intervals (CI).If the non-inferiority hypothesis is confirmed, it will be followed with a test of superiority using a log-rank test."|Hazard Ratio (HR)|0.71|||<|0.025|TWO_SIDED|95.0|0.48|1.05|||Regression, Cox|||||1.05|0.48|< 0.025
72444570|NCT02596126|144403539|SUPERIORITY|If the non-inferiority hypothesis is confirmed, it will be followed with a test of superiority using a logrank test.|||||<|0.05|||||||Log Rank|||||||< 0.05
72444571|NCT02596126|144403540|NON_INFERIORITY|"Non-inferiority hypothesis will be tested using a univariable Cox PH regression model including treatment group as the only covariate and stratified by country.~One-sided non-inferiority test on the primary endpoint where the alpha level will be set to 2.5%.~All statistical analyses will use 95% confidence intervals (CI).If the non-inferiority hypothesis is confirmed, it will be followed with a test of superiority using a log-rank test."|Hazard Ratio (HR)|0.7|||<|0.025|TWO_SIDED|95.0|0.39|1.26|||Regression, Cox|||||1.26|0.39|< 0.025
72444572|NCT02596126|144403540|SUPERIORITY|If the non-inferiority hypothesis is confirmed, it will be followed with a test of superiority using a logrank test.|||||<|0.05|||||||Log Rank|||||||< 0.05
72444573|NCT02596126|144403541|NON_INFERIORITY|"Non-inferiority hypothesis will be tested using a univariable Cox PH regression model including treatment group as the only covariate and stratified by country.~One-sided non-inferiority test on the primary endpoint where the alpha level will be set to 2.5%.~All statistical analyses will use 95% confidence intervals (CI).If the non-inferiority hypothesis is confirmed, it will be followed with a test of superiority using a log-rank test."|Hazard Ratio (HR)|0.96|||<|0.025|TWO_SIDED|95.0|0.57|1.63|||Regression, Cox|||||1.63|0.57|< 0.025
72444574|NCT02596126|144403541|SUPERIORITY|If the non-inferiority hypothesis is confirmed, it will be followed with a test of superiority using a logrank test.|||||<|0.05|||||||Log Rank|||||||< 0.05
72469478|NCT03494985|144462696|OTHER||LS mean difference|0.6|||<|0.0001|TWO_SIDED|95.0|0.3|0.9||p-value was adjusted using Dunnett's method for multiple comparisons.|ANOVA|ANOVA model with factors for treatment, study site and DMI stratification (mild, moderate, severe).|First named treatment minus second named treatment such that a positive value favours the first named treatment.|||0.9|0.3|<0.0001
72469479|NCT03036124|144462703|SUPERIORITY||Hazard Ratio (HR)|0.74|||<|0.0001||95.0|0.65|0.85|||Regression, Cox|Stratified by Type 2 Diabetes status at randomization and including the history of hospitalizations due to Heart failure as a factor.||||0.85|0.65|<0.0001
72619214|NCT01655069|144769069|OTHER||Adjusted change from baseline|-1.52|STANDARD_ERROR_OF_MEAN|0.16|||TWO_SIDED|95.0|-1.83|-1.22|||Repeated Measures ANCOVA|Duration of solifenacin treatment: 40 weeks||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant."||-1.22|-1.83|
72444575|NCT02596126|144403542|EQUIVALENCE|Mean and standard devation for each score will be reported by treatment group at 6 months and 2 years. Comparison of mean scores between treatment groups at 6 months and 2 years will be made using a two-sample t-test. The difference in mean score and 95% CI will be reported.|Mean Difference (Final Values)|3.09|||<|0.05|TWO_SIDED|95.0|1.38|4.79|||t-test, 2 sided|||Patient satisfaction is measured at visit 1 (6 months) and visit 3 (2 years) using the Treatment Satisfaction Questionnaire for Medication (TSQM) version 1.4 a 14-item psychometric instrument comprising of four domains: effectiveness (questions 1 to 3), side effects (questions 4 to 8), convenience (questions 9 to 11) and global satisfaction (questions 12 to 14).||4.79|1.38|< 0.05
72444576|NCT02596126|144403543|EQUIVALENCE|Mean and standard devation for each score will be reported by treatment group at 6 months and 2 years. Comparison of mean scores between treatment groups at 6 months and 2 years will be made using a two-sample t-test. The difference in mean score and 95% CI will be reported.|Mean Difference (Final Values)|-5.19|||<|0.05|TWO_SIDED|95.0|-12.73|2.35|||t-test, 2 sided|||Patient satisfaction is measured at visit 1 (6 months) and visit 3 (2 years) using the Treatment Satisfaction Questionnaire for Medication (TSQM) version 1.4 a 14-item psychometric instrument comprising of four domains: effectiveness (questions 1 to 3), side effects (questions 4 to 8), convenience (questions 9 to 11) and global satisfaction (questions 12 to 14).||2.35|-12.73|< 0.05
72444577|NCT02596126|144403544|EQUIVALENCE|Mean and standard devation for each score will be reported by treatment group at 6 months and 2 years. Comparison of mean scores between treatment groups at 6 months and 2 years will be made using a two-sample t-test. The difference in mean score and 95% CI will be reported.|Mean Difference (Final Values)|7.09|||<|0.05|TWO_SIDED|95.0|5.57|8.62|||t-test, 2 sided|||Patient satisfaction is measured at visit 1 (6 months) and visit 3 (2 years) using the Treatment Satisfaction Questionnaire for Medication (TSQM) version 1.4 a 14-item psychometric instrument comprising of four domains: effectiveness (questions 1 to 3), side effects (questions 4 to 8), convenience (questions 9 to 11) and global satisfaction (questions 12 to 14).||8.62|5.57|< 0.05
72444578|NCT02596126|144403545|EQUIVALENCE|Mean and standard devation for each score will be reported by treatment group at 6 months and 2 years. Comparison of mean scores between treatment groups at 6 months and 2 years will be made using a two-sample t-test. The difference in mean score and 95% CI will be reported.|Mean Difference (Final Values)|3.79|||<|0.05|TWO_SIDED|95.0|2.04|5.55|||t-test, 2 sided|||Patient satisfaction is measured at visit 1 (6 months) and visit 3 (2 years) using the Treatment Satisfaction Questionnaire for Medication (TSQM) version 1.4 a 14-item psychometric instrument comprising of four domains: effectiveness (questions 1 to 3), side effects (questions 4 to 8), convenience (questions 9 to 11) and global satisfaction (questions 12 to 14).||5.55|2.04|< 0.05
72444579|NCT02596126|144403546|EQUIVALENCE|Mean and standard devation for each score will be reported by treatment group at 6 months and 2 years. Comparison of mean scores between treatment groups at 6 months and 2 years will be made using a two-sample t-test. The difference in mean score and 95% CI will be reported.|Mean Difference (Final Values)|5.26|||<|0.05|TWO_SIDED|95.0|3.59|6.94|||t-test, 2 sided|||Patient satisfaction is measured at visit 1 (6 months) and visit 3 (2 years) using the Treatment Satisfaction Questionnaire for Medication (TSQM) version 1.4 a 14-item psychometric instrument comprising of four domains: effectiveness (questions 1 to 3), side effects (questions 4 to 8), convenience (questions 9 to 11) and global satisfaction (questions 12 to 14).||6.94|3.59|< 0.05
72619215|NCT01655069|144769069|OTHER||Adjusted change from baseline|-1.83|STANDARD_ERROR_OF_MEAN|0.2|||TWO_SIDED|95.0|-2.22|-1.43|||Repeated Measures ANCOVA|Duration of solifenacin treatment: 52 weeks||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant."||-1.43|-2.22|
72619216|NCT01655069|144769069|OTHER||Adjusted change from baseline|-0.93|STANDARD_ERROR_OF_MEAN|0.39|||TWO_SIDED|95.0|-1.73|-0.13|||Repeated Measures ANCOVA|Duration of solifenacin treatment: 3 weeks||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant."||-0.13|-1.73|
72444580|NCT02596126|144403547|EQUIVALENCE|Mean and standard devation for each score will be reported by treatment group at 6 months and 2 years. Comparison of mean scores between treatment groups at 6 months and 2 years will be made using a two-sample t-test. The difference in mean score and 95% CI will be reported.|Mean Difference (Final Values)|4.55|||<|0.05|TWO_SIDED|95.0|-4.35|13.46|||t-test, 2 sided|||Patient satisfaction is measured at visit 1 (6 months) and visit 3 (2 years) using the Treatment Satisfaction Questionnaire for Medication (TSQM) version 1.4 a 14-item psychometric instrument comprising of four domains: effectiveness (questions 1 to 3), side effects (questions 4 to 8), convenience (questions 9 to 11) and global satisfaction (questions 12 to 14).||13.46|-4.35|< 0.05
72444581|NCT02596126|144403548|EQUIVALENCE|Mean and standard devation for each score will be reported by treatment group at 6 months and 2 years. Comparison of mean scores between treatment groups at 6 months and 2 years will be made using a two-sample t-test. The difference in mean score and 95% CI will be reported.|Mean Difference (Final Values)|7.11|||<|0.05|TWO_SIDED|95.0|5.55|8.67|||t-test, 2 sided|||Patient satisfaction is measured at visit 1 (6 months) and visit 3 (2 years) using the Treatment Satisfaction Questionnaire for Medication (TSQM) version 1.4 a 14-item psychometric instrument comprising of four domains: effectiveness (questions 1 to 3), side effects (questions 4 to 8), convenience (questions 9 to 11) and global satisfaction (questions 12 to 14).||8.67|5.55|< 0.05
72469480|NCT03036124|144462704|SUPERIORITY||Hazard Ratio (HR)|0.75|||<|0.0001||95.0|0.65|0.85|||Regression, Cox|Stratified by Type 2 Diabetes status at randomization and including the history of hospitalizations due to Heart failure as a factor.||||0.85|0.65|<0.0001
72469481|NCT03036124|144462705|SUPERIORITY||Rate Ratio (RR)|0.75||||0.0002||95.0|0.65|0.88|||LWYY proportional rates model|Stratified by Type 2 Diabetes status at randomization and including the history of hospitalizations due to Heart failure as a factor.||||0.88|0.65|0.0002
72619217|NCT01655069|144769069|OTHER||Adjusted change from baseline|-0.94|STANDARD_ERROR_OF_MEAN|0.26|||TWO_SIDED|95.0|-1.48|-0.4|||Repeated Measures ANCOVA|Duration of solifenacin treatment: 6 weeks||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant."||-0.40|-1.48|
72619218|NCT01655069|144769069|OTHER||Adjusted change from baseline|-0.81|STANDARD_ERROR_OF_MEAN|0.31|||TWO_SIDED|95.0|-1.46|-0.17|||Repeated Measures ANCOVA|Duration of solifenacin treatment: 9 weeks||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant."||-0.17|-1.46|
72619219|NCT01655069|144769069|OTHER||Adjusted change from baseline|-0.91|STANDARD_ERROR_OF_MEAN|0.3|||TWO_SIDED|95.0|-1.53|-0.28|||Repeated Measures ANCOVA|Duration of solifenacin treatment: 12 weeks||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant."||-0.28|-1.53|
72444582|NCT02596126|144403549|EQUIVALENCE|Mean and standard devation for each score will be reported by treatment group at 6 months and 2 years. Comparison of mean scores between treatment groups at 6 months and 2 years will be made using a two-sample t-test. The difference in mean score and 95% CI will be reported.|Mean Difference (Final Values)|6.6|||<|0.05|TWO_SIDED|95.0|4.93|8.27|||t-test, 2 sided|||Patient satisfaction is measured at visit 1 (6 months) and visit 3 (2 years) using the Treatment Satisfaction Questionnaire for Medication (TSQM) version 1.4 a 14-item psychometric instrument comprising of four domains: effectiveness (questions 1 to 3), side effects (questions 4 to 8), convenience (questions 9 to 11) and global satisfaction (questions 12 to 14).||8.27|4.93|< 0.05
72444583|NCT02596126|144403550|SUPERIORITY|Time to first event will be investigated using Cox proportional hazards regression. Hazard ratios and 95% confidence intervals will be obtained from the Cox proportional hazards model. P-values will be obtained using the log-rank test.|Hazard Ratio (HR)|1.42|||<|0.05|TWO_SIDED|95.0|0.97|2.07|||Log Rank|||Statistical analysis title - Non-cardiovascular death||2.07|0.97|< 0.05
72444584|NCT00812461|144403560|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.72|STANDARD_ERROR_OF_MEAN|0.68||0.012|TWO_SIDED|95.0|-3.07|-0.38|||Adjusted change from Baseline to Month 6||The Number of Participants Analyzed is participants with efficacy measurement available at this endpoint, that is, 229 participants in the placebo group and 212 participants in the nalmefene group.|"The primary hypothesis concerned the treatment effect at Month 6. The null hypothesis of no difference in treatment effect was tested against the alternative hypothesis that there was a difference in treatment effect.~MMRM model with the Baseline score as a covariate; site, sex, time in months (Month 1-6); and treatment as fixed effects. The Baseline score-by-time and treatment-by-time interactions were also included in the model. An unstructured covariance matrix was used."||-0.38|-3.07|0.012
72469482|NCT03036124|144462706|SUPERIORITY||Win Ratio (WR)|1.18|||<|0.0001||95.0|1.11|1.26||The p-value is obtained from a rank ANCOVA adjusted for baseline KCCQ score and stratified by T2DM status at randomization.|Win Ratio|Stratified by Type 2 Diabetes status at randomization and including baseline score as a covariate.|The composite of change from baseline in total symptom score at 8 months, or death before 8 months.|||1.26|1.11|<0.0001
72469483|NCT03036124|144462707|SUPERIORITY||Hazard Ratio (HR)|0.71||||0.1681||95.0|0.44|1.16|||Regression, Cox|Stratified by Type 2 Diabetes status at randomization and including baseline eGFR as a covariate.||||1.16|0.44|0.1681
72469484|NCT03036124|144462708|SUPERIORITY||Hazard Ratio (HR)|0.83||||0.0217||95.0|0.71|0.97|||Regression, Cox|Stratified by Type 2 Diabetes status at randomization.||||0.97|0.71|0.0217
72469485|NCT03670277|144462710|OTHER|Statistically significance of difference. Statistical difference will be concluded if the lower limit was greater than 0 or the upper limit was less than 0.|Least Square Mean Difference|-0.013|STANDARD_ERROR_OF_MEAN|0.035|||TWO_SIDED|95.0|-0.081|0.056|||Mixed Models Analysis|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.|Mean difference was calculated as Test - Control|This was a pilot study for assessing the investigational test articles. As such, the sample size was not determined based on any power analysis with regard to the primary endpoint.||0.056|-0.081|
72469486|NCT03670277|144462711|OTHER|Statistically significance of difference. Statistical difference will be concluded if the lower limit was greater than 0 or the upper limit was less than 0.|Least Square Mean Difference|0.031|STANDARD_ERROR_OF_MEAN|0.035|||TWO_SIDED|95.0|-0.037|0.1|||Mixed Models Analysis|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.|Mean difference was calculated as Test - Control|This was a pilot study for assessing the investigational test articles. As such, the sample size was not determined based on any power analysis with regard to the primary endpoint.||0.100|-0.037|
72469487|NCT03670277|144462712|OTHER|Statistically significance of difference. Statistical difference would be concluded if the lower limit was greater than 0 or the upper limit was less than 0.|Least Square Mean Difference|3.403|STANDARD_ERROR_OF_MEAN|0.431|||TWO_SIDED|95.0|2.557|4.248|||Mixed Models Analysis|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.|Mean difference was calculated as Test - Control|At -30°||4.248|2.557|
72469488|NCT03670277|144462712|OTHER|Statistically significance of difference. Statistical difference would be concluded if the lower limit was greater than 0 or the upper limit was less than 0.|Least Square Mean Difference|2.431|STANDARD_ERROR_OF_MEAN|0.431|||TWO_SIDED|95.0|1.585|3.277|||Mixed Models Analysis|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.|Mean difference was calculated as Test - Control|At +30°||3.277|1.585|
72469489|NCT03670277|144462713|OTHER|Statistically significance of difference. Statistical difference would be concluded if the lower limit was greater than 0 or the upper limit was less than 0.|Least Square Mean Difference|3.039|STANDARD_ERROR_OF_MEAN|0.603|||TWO_SIDED|95.0|1.854|4.225|||Mixed Models Analysis|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.|Mean Difference was calculated as Test - Control|At -30°||4.225|1.854|
72444585|NCT00812461|144403561|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.95|STANDARD_ERROR_OF_MEAN|2.89||0.088|TWO_SIDED|95.0|-10.63|0.73|||Adjusted change from Baseline to Month 6||The Number of Participants Analyzed is participants with efficacy measurement available at this endpoint, that is, 229 participants in the placebo group and 212 participants in the nalmefene group.|"The primary hypothesis concerned the treatment effect at Month 6. The null hypothesis of no difference in treatment effect was tested against the alternative hypothesis that there was a difference in treatment effect.~MMRM model with the Baseline score as a covariate; site, sex, time in months (Month 1-6); and treatment as fixed effects. The Baseline score-by-time and treatment-by-time interactions were also included in the model. An unstructured covariance matrix was used."||0.73|-10.63|0.088
72444586|NCT00812461|144403562|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.92||||0.63|TWO_SIDED|95.0|0.67|1.27|||Adjusted Odds Ratio (OR) response|||The analysis of RSDRL used a logistic regression (LREG) model, with country, sex, Baseline DRL, and treatment as fixed effects, and missing values were imputed using individual-patient predicted values of TAC derived from the MMRM model.||1.27|0.67|0.630
72444587|NCT00812461|144403563|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.23|STANDARD_ERROR_OF_MEAN|0.11||0.029|TWO_SIDED|95.0|-0.44|-0.02|||Adjusted change from Baseline to Week 24||The Number of Participants Analyzed is participants with efficacy measurement available at this endpoint, that is, 225 participants in the placebo group and 203 participants in the nalmefene group.|MMRM model with the Baseline score as a covariate, and site, sex, time in weeks, and treatment as fixed effects. The Baseline score-by-time and treatment-by-time interactions were also included in the model; an unstructured covariance matrix was used.||-0.02|-0.44|0.029
72444588|NCT00812461|144403564|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.17|STANDARD_ERROR_OF_MEAN|0.11||0.111|TWO_SIDED|95.0|-0.38|0.04|||Adjusted change from Baseline to Week 24||The Number of Participants Analyzed is participants with efficacy measurement available at this endpoint, that is, 225 participants in the placebo group and 203 participants in the nalmefene group.|MMRM model with the Baseline CGI-S score as a covariate, and site, sex, time in weeks, and treatment as fixed effects. The Baseline CGI-S score-by-time and treatment-by-time interactions were also included in the model. An unstructured covariance matrix was used.||0.04|-0.38|0.111
72444589|NCT00812461|144403565|SUPERIORITY_OR_OTHER||Ratio to placebo|0.96||||0.529|TWO_SIDED|95.0|0.86|1.08|||[Adjusted values||The Number of Participants Analyzed is participants with efficacy measurement available at this endpoint, that is, 224 participants in the placebo group and 207 participants in the nalmefene group.|Log-transformed GGT values were analysed using an MMRM model with the log-transformed Baseline value as a covariate, and site, sex, time in weeks, and treatment as fixed effects. Logtransformed Baseline value-by-time interaction and treatment-by-time interaction were included in the model. An unstructured covariance matrix was used.||1.08|0.86|0.529
72444590|NCT00812461|144403566|SUPERIORITY_OR_OTHER||Ratio to placebo|0.92||||0.049|TWO_SIDED|95.0|0.84|1.0|||[Adjusted values||The Number of Participants Analyzed is participants with efficacy measurement available at this endpoint, that is, 222 participants in the placebo group and 205 participants in the nalmefene group.|Log-transformed ALAT values were analysed using an MMRM model with the log-transformed Baseline value as a covariate, and site, sex, time in weeks, and treatment as fixed effects. Logtransformed Baseline value-by-time and treatment-by-time interactions were included in the model. An unstructured covariance matrix was used.||1.00|0.84|0.049
72444591|NCT03328702|144403590|SUPERIORITY|Repeated measures ANOVA|Mean Difference (Net)|0.01|||<|0.05|TWO_SIDED|||||Repeated measures ANOVA, N=4|ANOVA|Repeated measures ANOVA||The null hypothesis is that there is no difference in total pharyngeal transit time with the use of CPAP||||<0.05
72444592|NCT04833777|144403591|SUPERIORITY||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
72444593|NCT04833777|144403592|SUPERIORITY||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
72444594|NCT04833777|144403593|SUPERIORITY||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
72444595|NCT04833777|144403594|SUPERIORITY||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
72444596|NCT04833777|144403595|SUPERIORITY||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
72444597|NCT04833777|144403596|SUPERIORITY||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
72444598|NCT04833777|144403597|SUPERIORITY||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
72444599|NCT04833777|144403598|SUPERIORITY||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
72444600|NCT04833777|144403599|OTHER||||||<|0.05|||||||Chi-squared|||||||<0.05
72444601|NCT04833777|144403600|OTHER||||||<|0.05|||||||Chi-squared|||||||<0.05
72560347|NCT03086135|144651320|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Threshold audiometry at 4000Hz at 4 weeks with the Osia system vs Unaided at visit 1.||||<0.0001
72444602|NCT04833777|144403601|OTHER||||||<|0.05|||||||Chi-squared|||||||<0.05
72444603|NCT04833777|144403602|OTHER||||||<|0.05|||||||Chi-squared|||||||<0.05
72444604|NCT04833777|144403603|OTHER||||||<|0.05|||||||Chi-squared|||||||<0.05
72444605|NCT04833777|144403604|OTHER||||||<|0.05|||||||Chi-squared|||||||<0.05
72444606|NCT04833777|144403606|OTHER||||||<|0.05|||||||Chi-squared|||||||<0.05
72444607|NCT04833777|144403607|OTHER||||||<|0.05|||||||Chi-squared|||||||<0.05
72444608|NCT03648840|144403610|OTHER||||||<|0.2|||||||t-test, 2 sided|||2-tailed, unpaired T-test||||<0.2
72444609|NCT05418296|144403611|SUPERIORITY||||||<|0.46|||||||t-test, 1 sided|||||||<0.46
72444610|NCT05418296|144403612|SUPERIORITY||||||<|0.00314|||||||t-test, 1 sided|||||||<0.00314
72444611|NCT05418296|144403613|SUPERIORITY||||||<|0.066|||||||t-test, 1 sided|||||||<0.066
72444612|NCT05418296|144403614|SUPERIORITY||||||<|0.085|||||||t-test, 1 sided|||||||<0.0850
72444613|NCT05418296|144403615|SUPERIORITY||||||<|0.0716|||||||t-test, 1 sided|||||||<0.0716
72560348|NCT03086135|144651320|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Threshold audiometry at 6000Hz at 4 weeks with the Osia system vs Unaided at visit 1.||||<0.0001
72560349|NCT03086135|144651320|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Threshold audiometry at 8000Hz at 4 weeks with the Osia system vs Unaided at visit 1.||||<0.0001
72560350|NCT03086135|144651320|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Threshold audiometry at 250Hz at 3 months with the Osia system vs Unaided at visit 1.||||<0.0001
72560351|NCT03086135|144651320|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Threshold audiometry at 500Hz at 3 months with the Osia system vs Unaided at visit 1.||||<0.0001
72444614|NCT03703700|144403619|OTHER||Risk Ratio (RR)|1.23||||0.042|TWO_SIDED|95.0|1.01|1.5|||Chi-squared|||||1.50|1.01|0.042
72444615|NCT03703700|144403620|OTHER|||||||0.781|||||||Wilcoxon (Mann-Whitney)|||||||0.781
72444616|NCT03703700|144403621|OTHER|||||||0.609|||||||Wilcoxon (Mann-Whitney)|||||||0.609
72444617|NCT03703700|144403622|OTHER|||||||0.528|||||||Wilcoxon (Mann-Whitney)|||||||0.528
72444618|NCT03703700|144403623|OTHER|||||||0.88|||||||Wilcoxon (Mann-Whitney)|||||||0.880
72444619|NCT03703700|144403624|OTHER|||||||0.289|||||||Wilcoxon (Mann-Whitney)|||||||0.289
72444620|NCT03703700|144403625|OTHER|||||||0.86|||||||Wilcoxon (Mann-Whitney)|||||||0.860
72444621|NCT03703700|144403626|OTHER|||||||0.163|||||||Wilcoxon (Mann-Whitney)|||||||0.163
72444622|NCT03703700|144403627|OTHER|||||||0.197|||||||Wilcoxon (Mann-Whitney)|||||||0.197
72497292|NCT01276821|144524393|NON_INFERIORITY_OR_EQUIVALENCE|Non - Inferiority Analysis|Mean Difference (Final Values)|1.33|STANDARD_DEVIATION|1.3|<|0.05|TWO_SIDED|95.0|0.78|1.82|||t-test, 2 sided|||"Null Hypothesis Efficacy of nebulised hypertonic saline (3%) with L-Epinephrine is not higer than as compared to L-Epinephrine given with 0.9% normal saline in the management of children aged 6 weeks to 24 months with mild to moderately severe bronchiolitis.~Alternate Hypothesis:~Nebulised hypertonic saline (3%) with L-Epinephrine is superior to 0.9% Normal saline with L-Epinephrine in the management of children aged 6 weeks to 24 months with mild to moderately severe bronchiolitis."||1.82|0.78|<0.05
72497293|NCT00988247|144524447|SUPERIORITY_OR_OTHER_LEGACY||LS mean treatment diff from placebo]|-0.97|||<|0.001|TWO_SIDED|95.0|-1.5|-0.5|||ANCOVA|The repeated measures ANCOVA included covariate adjustment for baseline, treatment, week and the treatment by week interaction.||||-0.5|-1.5|<0.001
72497294|NCT00988247|144524448|SUPERIORITY_OR_OTHER_LEGACY||LS mean treatment diff from placebo]|-0.96|||<|0.001|TWO_SIDED|95.0|-1.4|-0.5|||ANCOVA|The repeated measures ANCOVA included covariate adjustment for baseline, treatment, week and the treatment by week interaction.||||-0.5|-1.4|<0.001
72497295|NCT00988247|144524449|SUPERIORITY_OR_OTHER_LEGACY||LS mean treatment diff from placebo]|-1.09|||<|0.001|TWO_SIDED|95.0|-1.6|-0.6|||ANCOVA|The repeated measures ANCOVA included covariate adjustment for baseline, treatment, week and the treatment by week interaction.||||-0.6|-1.6|<0.001
72444623|NCT03703700|144403628|OTHER|||||||0.178|||||||Wilcoxon (Mann-Whitney)|||||||0.178
72444624|NCT03703700|144403629|OTHER|||||||0.549|||||||Wilcoxon (Mann-Whitney)|||||||0.549
72444625|NCT03703700|144403630|OTHER||Risk Ratio (RR)|1.19||||0.035|TWO_SIDED|95.0|1.01|1.4|||Chi-squared|||||1.40|1.01|0.035
72497296|NCT00988247|144524450|SUPERIORITY_OR_OTHER_LEGACY||LS mean treatment diff from placebo]|-1.1|||<|0.001|TWO_SIDED|95.0|-1.6|-0.6|||ANCOVA|The repeated measures ANCOVA included covariate adjustment for baseline, treatment, week and the treatment by week interaction.||||-0.6|-1.6|<0.001
72497297|NCT00988247|144524451|SUPERIORITY_OR_OTHER_LEGACY||treatment difference|-0.3||||0.143|TWO_SIDED|95.0|-0.7|0.1|||ANCOVA|ANCOVA with treatment, baseline and pooled center in the model.||||0.1|-0.7|0.143
72497298|NCT00988247|144524452|SUPERIORITY_OR_OTHER_LEGACY||treatment difference|-0.49||||0.13|TWO_SIDED|95.0|-1.1|0.1|||ANCOVA|ANCOVA with treatment, baseline and pooled center in the model.||||0.1|-1.1|0.130
72619220|NCT01655069|144769069|OTHER||Adjusted change from baseline|-0.71|STANDARD_ERROR_OF_MEAN|0.52|||TWO_SIDED|95.0|-1.8|-0.38|||Repeated Measures ANCOVA|Duration of solifenacin treatment: 24 weeks||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant."||-0.38|-1.80|
72444626|NCT03703700|144403631|OTHER||Risk Ratio (RR)|1.18||||0.034|TWO_SIDED|95.0|1.01|1.37|||Chi-squared|||||1.37|1.01|0.034
72444627|NCT03703700|144403632|OTHER||Risk Ratio (RR)|1.22||||0.022|TWO_SIDED|95.0|1.03|1.45|||Chi-squared|||||1.45|1.03|0.022
72444628|NCT03703700|144403633|OTHER||Risk Ratio (RR)|0.94||||0.707|TWO_SIDED|95.0|0.68|1.3|||Chi-squared|||||1.30|0.68|0.707
72444629|NCT03703700|144403634|OTHER||Risk Ratio (RR)|0.97||||0.878|TWO_SIDED|95.0|0.66|1.42|||Chi-squared|||||1.42|0.66|0.878
72444630|NCT03703700|144403635|OTHER|||||||0.564|||||||Wilcoxon (Mann-Whitney)|||Singleton||||0.564
72444631|NCT03703700|144403635|OTHER|||||||0.417|||||||Wilcoxon (Mann-Whitney)|||Twin||||0.417
72444632|NCT03703700|144403636|OTHER|||||||0.985|||||||Wilcoxon (Mann-Whitney)|||Singleton||||0.985
72444633|NCT03703700|144403636|OTHER|||||||0.157|||||||Wilcoxon (Mann-Whitney)|||Twin||||0.157
72444634|NCT03703700|144403637|OTHER||Risk Ratio (RR)|1.07||||0.789|TWO_SIDED|95.0|0.65|1.78|||Chi-squared|||||1.78|0.65|0.789
72444635|NCT03703700|144403638|OTHER||Risk Ratio (RR)|1.09||||0.769|TWO_SIDED|95.0|0.61|1.94|||Chi-squared|||||1.94|0.61|0.769
72444636|NCT03703700|144403639|OTHER||Risk Ratio (RR)|0.41||||0.59|TWO_SIDED|95.0|0.04|4.45|||Fisher Exact|||||4.45|0.04|0.590
72444637|NCT03703700|144403640|OTHER||Risk Ratio (RR)|2.04||||0.465|TWO_SIDED|95.0|0.4|10.39|||Fisher Exact|||||10.39|0.40|0.465
72444638|NCT05374837|144403732|SUPERIORITY||Odds Ratio (OR)|0.9585||||0.145|TWO_SIDED|95.0|0.4276|2.1485||The a priori threshold for statistical significance is \<0.05. The p-value is for the intervention by time interaction.|Regression, Logistic||Odds of consuming a minimum acceptable diet in control group at endline.|||2.1485|0.4276|0.145
72444639|NCT05374837|144403732|SUPERIORITY||Odds Ratio (OR)|0.9669||||0.145|TWO_SIDED|95.0|0.43|2.1742||The a priori threshold for statistical significance is \<0.05. The p-value is for the intervention by time interaction.|Regression, Logistic||Odds of consuming a minimum acceptable diet in intervention group at endline.|||2.1742|0.43|0.145
72444640|NCT05374837|144403733|SUPERIORITY||Odds Ratio (OR)|0.3084||||0.179|TWO_SIDED|95.0|0.1977|0.481||The a priori threshold for statistical significance is \<0.05. The p-value is for the intervention by time interaction.|Regression, Logistic|||||0.481|0.1977|0.179
72444641|NCT05374837|144403733|SUPERIORITY||Odds Ratio (OR)|0.438||||0.179|TWO_SIDED|95.0|0.2983|0.6431||The a priori threshold for statistical significance is \<0.05. The p-value is for the intervention by time interaction.|Regression, Logistic|||||0.6431|0.2983|0.179
72444642|NCT05374837|144403739|SUPERIORITY|||||||0.054||||||A priori threshold for statistical significance \<0.05.|Chi-squared|||||||0.054
72444643|NCT05374837|144403740|SUPERIORITY|||||||0.65||||||A priori threshold for statistical significance \<0.05|Chi-squared|||||||0.65
72560352|NCT03086135|144651320|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Threshold audiometry at 750Hz at 3 months with the Osia system vs Unaided at visit 1.||||<0.0001
72444644|NCT03149315|144403746|SUPERIORITY|Values for grouped data were reported as mean ± SD and were calculated using Graphpad Prism 7 software (La Jolla, CA), which was also used for generating figures and for statistical analyses. Changes in skin test area (wheal and flare) were analyzed at each time point (after 2 doses, 4 doses, etc) using Friedman tests for grouped analysis and Wilcoxon signed rank tests between pairs.|||||<|0.0001||||||The above p value reflects the statistical analysis of skin test area between baseline and 2 doses of ibrutinib.|Wilcoxon (Mann-Whitney)|Changes in skin test area at each time point were analyzed using Friedman tests for grouped analysis and Wilcoxon signed rank tests between pairs.||||||<0.0001
72444645|NCT03149315|144403747|SUPERIORITY|Changes in BAT were analyzed at each time point (after 2 doses, 4 doses, etc) using repeated measures ANOVA for grouped analysis and paired Students t tests between pairs. A p value \< 0.05 was considered significant.|||||<|0.001||||||The above p value reflects the statistical analysis of BAT between baseline and 2 doses of ibrutinib.|ANOVA|Changes in BAT were analyzed at each time point using repeated measures ANOVA for grouped analysis and paired Students t tests between pairs.||||||<0.001
72444646|NCT05406921|144403778|SUPERIORITY||Mean Difference (Net)|0.32|||<|0.05|TWO_SIDED||||||ANOVA|||This was a feasibility study and not powered to detect significant differences pre-/post-intervention.||||<0.05
72444647|NCT04299009|144403780|OTHER|multilevel linear models with Epworth sleepiness score scores as the dependent variable; treatment block (BLT vs sBLT) as a fixed effect; treatment sequence as a covariate; and participant intercept as a random effect.|regression coefficient|2.45|||<|0.05|TWO_SIDED|95.0|-0.3|5.19|||Mixed Models Analysis|||||5.19|-0.30|<0.05
72444648|NCT05458011|144403813|OTHER||LS Mean Difference|-1.8|STANDARD_ERROR_OF_MEAN|0.44|<|0.0001|TWO_SIDED|95.0|-2.66|-0.95|||ANCOVA|||||-0.95|-2.66|<0.0001
72444649|NCT02384317|144403833|SUPERIORITY||Slope|-2.4|STANDARD_DEVIATION|141.77||0.965|TWO_SIDED|95.0|-133.6|128.7|||Random coefficients regression|||||128.7|-133.6|0.965
72444650|NCT05956002|144403883|EQUIVALENCE|For bioequivalence, the 90% CIs of the adjusted geometric mean ratio of AUClast for etrasimod 2 mg mini tablets mixed with applesauce (tests) compared with etrasimod 2 mg clinical IR tablet (reference) were required to be within the 80 to 125% range.|Ratio of adjusted geometric means|94.66|||||TWO_SIDED|90.0|91.33|98.12|||||The ratio and 90% CIs are expressed as percentages.|Analysis was performed for etrasimod 2mg mini tablets in applesauce vs etrasimod 2mg clinical IR tablet mixed effect model with sequence, period and treatment as fixed effects and participant within the sequence as a random effect.||98.12|91.33|
72444651|NCT05956002|144403883|EQUIVALENCE|For bioequivalence, the 90% CIs of the adjusted geometric mean ratio of AUClast for etrasimod 2 mg mini tablets mixed with chocolate pudding (tests) compared with etrasimod 2 mg clinical IR tablet (reference) were required to be within the 80 to 125% range.|Ratio of adjusted geometric means|94.96|||||TWO_SIDED|90.0|91.69|98.34|||||The ratio and 90% CIs are expressed as percentages.|Analysis was performed for etrasimod 2 mg mini tablets in chocolate pudding vs etrasimod 2 mg clinical IR tablet using mixed effect model with sequence, period and treatment as fixed effects and participant within the sequence as a random effect.||98.34|91.69|
72444652|NCT05956002|144403883|EQUIVALENCE|For bioequivalence, the 90% CIs of the adjusted geometric mean ratio of AUClast for etrasimod 2 mg mini tablets mixed with water (tests) compared with etrasimod 2 mg clinical IR tablet (reference) were required to be within the 80 to 125% range.|Ratio of adjusted geometric means|85.86|||||TWO_SIDED|90.0|82.9|88.92|||||The ratio and 90% CIs are expressed as percentages.|Analysis was performed for etrasimod 2 mg mini tablets in water vs etrasimod 2 mg clinical IR tablet using mixed effect model with sequence, period and treatment as fixed effects and participant within the sequence as a random effect.||88.92|82.90|
72444653|NCT05956002|144403883|EQUIVALENCE|For bioequivalence, the 90% CIs of the adjusted geometric mean ratio of AUClast for etrasimod 2 mg mini tablets mixed with yogurt (tests) compared with etrasimod 2 mg clinical IR tablet (reference) were required to be within the 80 to 125% range.|Ratio of adjusted geometric means|93.24|||||TWO_SIDED|90.0|89.76|96.84|||||The ratio and 90% CIs are expressed as percentages.|Analysis was performed for etrasimod 2 mg mini tablets in yogurt vs etrasimod 2 mg clinical IR tablet using mixed effect model with sequence, period and treatment as fixed effects and participant within the sequence as a random effect.||96.84|89.76|
72444654|NCT05956002|144403884|EQUIVALENCE|For bioequivalence, the 90% CIs of the adjusted geometric mean ratio of AUCinf for etrasimod 2 mg mini tablets mixed with applesauce (tests) compared with etrasimod 2 mg clinical IR tablet (reference) were required to be within the 80 to 125% range.|Ratio of adjusted geometric means|94.36|||||TWO_SIDED|90.0|90.97|97.89|||||The ratio and 90% CIs are expressed as percentages.|Analysis was performed for etrasimod 2 mg mini tablets in applesauce vs etrasimod 2 mg clinical IR tablet using mixed effect model with sequence, period and treatment as fixed effects and participant within the sequence as a random effect.||97.89|90.97|
72497299|NCT01169779|144524463|SUPERIORITY_OR_OTHER||Least squares (LS) mean difference|-0.36|STANDARD_ERROR_OF_MEAN|0.099||0.0004|TWO_SIDED|95.0|-0.551|-0.162||Statistical testing:2-sided at significance level=0.05. Analysis of co-variance (ANCOVA) included treatment arms, randomization strata of screening HbA1c (\<8.0,\>=8.0%), sulfonylurea use (Yes,No), country as fixed effects, baseline HbA1c as covariate.|ANCOVA|||To detect a difference of 0.5% in change in HbA1c at Week 24 between lixisenatide arm and placebo arm, 190 patients per group would provide a power of 96% assuming common standard deviation of 1.3% with 2-sided test at 5% significance level.||-0.162|-0.551|0.0004
72560353|NCT03086135|144651320|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Threshold audiometry at 1000Hz at 3 months with the Osia system vs Unaided at visit 1.||||<0.0001
72560354|NCT03086135|144651320|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Threshold audiometry at 1500Hz at 3 months with the Osia system vs Unaided at visit 1.||||<0.0001
72560355|NCT03086135|144651320|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Threshold audiometry at 2000Hz at 3 months with the Osia system vs Unaided at visit 1.||||<0.0001
72560356|NCT03086135|144651320|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Threshold audiometry at 3000Hz at 3 months with the Osia system vs Unaided at visit 1.||||<0.0001
72560357|NCT03086135|144651320|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Threshold audiometry at 4000Hz at 3 months with the Osia system vs Unaided at visit 1.||||<0.0001
72444655|NCT05956002|144403884|EQUIVALENCE|For bioequivalence, the 90% CIs of the adjusted geometric mean ratio of AUCinf for etrasimod 2 mg mini tablets mixed with chocolate pudding (tests) compared with etrasimod 2 mg clinical IR tablet (reference) were required to be within the 80 to 125% range.|Ratio of adjusted geometric means|94.75|||||TWO_SIDED|90.0|91.41|98.2|||||The ratio and 90% CIs are expressed as percentages.|Analysis was performed for etrasimod 2 mg mini tablets in chocolate pudding vs etrasimod 2 mg clinical IR tablet using mixed effect model with sequence, period and treatment as fixed effects and participant within the sequence as a random effect.||98.20|91.41|
72444656|NCT05956002|144403884|EQUIVALENCE|For bioequivalence, the 90% CIs of the adjusted geometric mean ratio of AUCinf for etrasimod 2 mg mini tablets mixed with water (tests) compared with etrasimod 2 mg clinical IR tablet (reference) were required to be within the 80 to 125% range.|Ratio of adjusted geometric means|85.44|||||TWO_SIDED|90.0|82.43|88.55|||||The ratio and 90% CIs are expressed as percentages.|Analysis was performed for etrasimod 2 mg mini tablets in water vs etrasimod 2 mg clinical IR tablet using mixed effect model with sequence, period and treatment as fixed effects and participant within the sequence as a random effect.||88.55|82.43|
72444657|NCT05956002|144403884|EQUIVALENCE|For bioequivalence, the 90% CIs of the adjusted geometric mean ratio of AUCinf for etrasimod 2 mg mini tablets mixed with yogurt (tests) compared with etrasimod 2 mg clinical IR tablet (reference) were required to be within the 80 to 125% range.|Ratio of adjusted geometric means|93.28|||||TWO_SIDED|90.0|89.61|97.1|||||The ratio and 90% CIs are expressed as percentages.|Analysis was performed for etrasimod 2 mg mini tablets in yogurt vs etrasimod 2 mg clinical IR tablet using mixed effect model with sequence, period and treatment as fixed effects and participant within the sequence as a random effect.||97.10|89.61|
72444658|NCT05956002|144403885|EQUIVALENCE|For bioequivalence, the 90% CIs of the adjusted geometric mean ratio of Cmax for etrasimod 2 mg mini tablets mixed with applesauce (tests) compared with etrasimod 2 mg clinical IR tablet (reference) were required to be within the 80 to 125% range.|Ratio of adjusted geometric means|94.7|||||TWO_SIDED|90.0|90.38|99.22|||||The ratio and 90% CIs are expressed as percentages.|Analysis was performed for etrasimod 2 mg mini tablets in applesauce vs etrasimod 2 mg clinical IR tablet using mixed effect model with sequence, period and treatment as fixed effects and participant within the sequence as a random effect.||99.22|90.38|
72444659|NCT05956002|144403885|EQUIVALENCE|For bioequivalence, the 90% CIs of the adjusted geometric mean ratio of Cmax for etrasimod 2 mg mini tablets mixed with chocolate pudding (tests) compared with etrasimod 2 mg clinical IR tablet (reference) were required to be within the 80 to 125% range.|Ratio of adjusted geometric means|92.72|||||TWO_SIDED|90.0|88.59|97.04|||||The ratio and 90% CIs are expressed as percentages.|Analysis was performed for etrasimod 2 mg mini tablets in chocolate pudding vs etrasimod 2 mg clinical IR tablet using mixed effect model with sequence, period and treatment as fixed effects and participant within the sequence as a random effect.||97.04|88.59|
72444660|NCT05956002|144403885|EQUIVALENCE|For bioequivalence, the 90% CIs of the adjusted geometric mean ratio of Cmax for etrasimod 2 mg mini tablets mixed with water (tests) compared with etrasimod 2 mg clinical IR tablet (reference) were required to be within the 80 to 125% range.|Ratio of adjusted geometric means|87.24|||||TWO_SIDED|90.0|83.35|91.31|||||The ratio and 90% CIs are expressed as percentages.|Analysis was performed for etrasimod 2 mg mini tablets in water vs etrasimod 2 mg clinical IR tablet using mixed effect model with sequence, period and treatment as fixed effects and participant within the sequence as a random effect.||91.31|83.35|
72444661|NCT05956002|144403885|EQUIVALENCE|For bioequivalence, the 90% CIs of the adjusted geometric mean ratio of Cmax for etrasimod 2 mg mini tablets mixed with yogurt (tests) compared with etrasimod 2 mg clinical IR tablet (reference) were required to be within the 80 to 125% range.|Ratio of adjusted geometric means|92.59|||||TWO_SIDED|90.0|88.24|97.17|||||The ratio and 90% CIs are expressed as percentages.|Analysis was performed for etrasimod 2 mg mini tablets in yogurt vs etrasimod 2 mg clinical IR tablet using mixed effect model with sequence, period and treatment as fixed effects and participant within the sequence as a random effect.||97.17|88.24|
72444662|NCT03978871|144403926|SUPERIORITY||||||<|0.001||||||The threshold for statistical significance was p = 0.05.|ANOVA|degrees of freedom =1.||We are reporting the p-value for the group (Growth Mindset vs. Brain Education) by time effect (pre-manipulation and post-manipulation). This is a test of between by within-subjects interaction effect.||||<0.001
72444663|NCT03978871|144403927|SUPERIORITY|The threshold for statistical significance was p = 0.05.||||||0.023|||||||ANOVA|degrees of freedom = 1.||We are reporting the p-value for the group (Growth Mindset vs. Brain Education) by time effect (pre-manipulation and post-manipulation). This is a test of between by within-subjects interaction effect.||||0.023
72444664|NCT03978871|144403927|SUPERIORITY|The threshold for statistical significance was p = 0.05.||||||0.034|||||||ANCOVA|degrees of freedom = 1.||We are reporting the p-value for the group (Growth Mindset vs. Brain Education) by time effect (pre-manipulation and post-manipulation). This is a test of between by within-subjects interaction effect. Clarity of the psycho-educational lessons was included as a covariate.||||0.034
72444665|NCT03978871|144403928|SUPERIORITY|The threshold for statistical significance was p = 0.0.5|||||<|0.001|||||||ANOVA|degrees of freedom = 1.||We are reporting the p-value for the group (Growth Mindset vs. Brain Education) by time effect (pre-manipulation and post-manipulation). This is a test of between by within-subjects interaction effect.||||<.001
72444666|NCT03978871|144403928|SUPERIORITY|The threshold for statistical significance was p = 0.05.||||||0.002|||||||ANCOVA|degrees of freedom = 1.||We are reporting the p-value for the group (Growth Mindset vs. Brain Education) by time effect (pre-manipulation and post-manipulation). This is a test of between by within-subjects interaction effect. Clarity of the psycho-educational lessons was included as a covariate.||||0.002
72444667|NCT03978871|144403929|SUPERIORITY|The threshold for statistical significance was p = 0.05.||||||0.227|||||||ANOVA|degrees of freedom = 1.||We are reporting the p-value for the group effect (Growth Mindset vs. Brain Education). This is a test of between-subjects effect.||||0.227
72444668|NCT03978871|144403930|SUPERIORITY|The threshold for statistical significance was p = 0.05.||||||0.272|||||||ANOVA|degrees of freedom = 1.||We are reporting the p-value for the group effect for accuracy (Growth Mindset vs. Brain Education). This is a test of between-subjects effect.||||0.272
72560358|NCT03086135|144651320|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Threshold audiometry at 6000Hz at 3 months with the Osia system vs Unaided at visit 1.||||<0.0001
72560359|NCT03086135|144651320|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Threshold audiometry at 8000Hz at 3 months with the Osia system vs Unaided at visit 1.||||<0.0001
72560360|NCT03086135|144651320|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Threshold audiometry at 250Hz at 6 months with the Osia system vs Unaided at visit 1.||||<0.0001
72444669|NCT03978871|144403931|SUPERIORITY|The threshold for statistical significance was p = 0.05||||||0.217|||||||ANOVA|degrees of freedom = 1.||We are reporting the p-value for the group effect (Growth Mindset vs. Brain Education) for the ERS emotion regulation involuntary dysregulation subscale post psycho-educational lesson. This is a test of between-subjects effect.||||0.217
72560361|NCT03086135|144651320|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Threshold audiometry at 500Hz at 6 months with the Osia system vs Unaided at visit 1.||||<0.0001
72560362|NCT03086135|144651320|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Threshold audiometry at 750Hz at 6 months with the Osia system vs Unaided at visit 1.||||<0.0001
72560363|NCT03086135|144651320|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Threshold audiometry at 1000Hz at 6 months with the Osia system vs Unaided at visit 1.||||<0.0001
72560364|NCT03086135|144651320|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Threshold audiometry at 1500Hz at 6 months with the Osia system vs Unaided at visit 1.||||<0.0001
72560365|NCT03086135|144651320|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Threshold audiometry at 2000Hz at 6 months with the Osia system vs Unaided at visit 1.||||<0.0001
72444670|NCT03978871|144403931|SUPERIORITY|The threshold for statistical significance was p = 0.05.||||||0.458|||||||ANCOVA|degrees of freedom = 1.||We are reporting the p-value for the group effect (Growth Mindset vs. Brain Education) for the ERS emotion regulation involuntary dysregulation subscale post psycho-educational lesson. This is a test of between-subjects effect. Clarity of the psycho-educational lessons was included as a covariate.||||0.458
72444671|NCT03978871|144403931|SUPERIORITY|The threshold for statistical significance was p = 0.05||||||0.037|||||||ANOVA|degrees of freedom = 1.||We are reporting the p-value for the group effect (Growth Mindset vs. Brain Education) for the ERS emotion regulation proactive engagement subscale post psycho-educational lesson. This is a test of between-subjects effect.||||0.037
72444672|NCT03978871|144403931|SUPERIORITY|The threshold for statistical significance was p = 0.05.||||||0.107|||||||ANCOVA|degrees of freedom = 1.||We are reporting the p-value for the group effect (Growth Mindset vs. Brain Education) for the ERS emotion regulation proactive engagement subscale post psycho-educational lesson. This is a test of between-subjects effect. Clarity of the psycho-educational lessons was included as a covariate.||||0.107
72444673|NCT03978871|144403931|SUPERIORITY|The threshold for statistical significance was p = 0.05.||||||0.369|||||||ANOVA|degrees of freedom = 1.||We are reporting the p-value for the group effect (Growth Mindset vs. Brain Education) for the ERS emotion regulation cognitive avoidance subscale post psycho-educational lesson. This is a test of between-subjects test.||||0.369
72560366|NCT03086135|144651320|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Threshold audiometry at 3000Hz at 6 months with the Osia system vs Unaided at visit 1.||||<0.0001
72560367|NCT03086135|144651320|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Threshold audiometry at 4000Hz at 6 months with the Osia system vs Unaided at visit 1.||||<0.0001
72560368|NCT03086135|144651320|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Threshold audiometry at 6000Hz at 6 months with the Osia system vs Unaided at visit 1.||||<0.0001
72560369|NCT03086135|144651320|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Threshold audiometry at 8000Hz at 6 months with the Osia system vs Unaided at visit 1.||||<0.0001
72560370|NCT03086135|144651320|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Threshold audiometry at 250Hz at 12 months with the Osia system vs Unaided at visit 1.||||<0.0001
72560371|NCT03086135|144651320|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Threshold audiometry at 500Hz at 12 months with the Osia system vs Unaided at visit 1.||||<0.0001
72560372|NCT03086135|144651320|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Threshold audiometry at 750Hz at 12 months with the Osia system vs Unaided at visit 1.||||<0.0001
72444674|NCT03978871|144403932|SUPERIORITY|Data were collected using a Siemens Prisma MRI 3T scanner and preprocessed with fMRIprep. An ROI mask was generated from left and right amygdala of the AAL1.V4 atlas. First-level contrast estimates (negative immerse \> neutral immerse) for each voxel within the ROI were averaged with MarsBaR to produce a single value for each person. A two-sample t-test was conducted in R to test for differences across intervention groups (mindset vs control).||||||0.265||||||The threshold for statistical significance was p \< 0.05.|t-test, 2 sided|t(146) = -1.12||||||0.265
72444675|NCT03978871|144403933|SUPERIORITY|Data were collected using a Siemens Prisma MRI 3T scanner and preprocessed with fMRIprep. An ROI mask was generated from left and right amygdala of the AAL1.V4 atlas. First-level contrast estimates (negative \> neutral) for each voxel within the ROI were averaged with MarsBaR to produce a single value for each person. A two-sample t-test was conducted in R to test for differences across intervention groups (mindset vs control).||||||0.96||||||The threshold for statistical significance was p \< 0.05|t-test, 2 sided|t(145) = -0.53||||||0.96
72560373|NCT03086135|144651320|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Threshold audiometry at 1000Hz at 12 months with the Osia system vs Unaided at visit 1.||||<0.0001
72560374|NCT03086135|144651320|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Threshold audiometry at 1500Hz at 12 months with the Osia system vs Unaided at visit 1.||||<0.0001
72560375|NCT03086135|144651320|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Threshold audiometry at 2000Hz at 12 months with the Osia system vs Unaided at visit 1.||||<0.0001
72560376|NCT03086135|144651320|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Threshold audiometry at 3000Hz at 12 months with the Osia system vs Unaided at visit 1.||||<0.0001
72560377|NCT03086135|144651320|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Threshold audiometry at 4000Hz at 12 months with the Osia system vs Unaided at visit 1.||||<0.0001
72560378|NCT03086135|144651320|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Threshold audiometry at 6000Hz at 12 months with the Osia system vs Unaided at visit 1.||||<0.0001
72444676|NCT03978871|144403934|SUPERIORITY|Data were preprocessed in fMRIprep. Separate right/left amygdala seeds were defined with the AAL1 atlas. Interaction regressors were created between seeds and task conditions. Average contrast estimates for interaction terms of relevant trials (negative reframe \> negative immerse) were extracted with MarsBaR from 15 ROIs in the FPN of a modified Schaefer atlas and the 30 values averaged. A two-sample t-test was conducted in R to compare average connectivity between groups (mindset vs control).||||||0.76||||||The threshold for statistical significance was p \< 0.05.|t-test, 2 sided|t(146) = -.3047||||||0.76
72444677|NCT03978871|144403935|SUPERIORITY|Data were preprocessed in fMRIprep. Separate right/left amygdala seeds were defined with the AAL1 atlas. Interaction regressors were created between seeds and task conditions. Average contrast estimates for interaction terms of relevant trials (negative \> neutral) were extracted with MarsBaR from 15 ROIs in the FPN of a modified Schaefer atlas and the 30 values averaged. A two-sample t-test was conducted in R to compare average connectivity between groups (mindset vs control).||||||0.048||||||The threshold for statistical significance was p \< 0.05|t-test, 2 sided|t(145) = 1.998, p = .048||||||.048
72444678|NCT03978871|144403936|SUPERIORITY|The threshold for statistical significance was p = 0.05.||||||0.833|||||||ANOVA|degrees of freedom =1.||We are reporting the p-value for the group (Growth Mindset vs. Brain Education) by time effect (pre-manipulation and post-manipulation). This is a test of between by within-subjects interaction effect.||||0.833
72444679|NCT03978871|144403937|SUPERIORITY|The threshold for statistical significance was p = 0.05.||||||0.321|||||||ANOVA|degrees of freedom = 1.||We are reporting the p-value for the group effect (Growth Mindset vs. Brain Education) across self-reported affect on the SET task. This is a test of between-subjects effect.||||0.321
72444680|NCT03978871|144403938|SUPERIORITY|The threshold for statistical significance was p = 0.05||||||0.002|||||||ANOVA|degrees of freedom = 1.||We are reporting the p-value for the group (Growth Mindset vs. Brain Education) by time effect (pre-manipulation and post-manipulation) for fixed emotion mindset scores from time 1 to time 2. This is a test of between by within-subjects interaction effect.||||0.002
72444681|NCT03978871|144403938|SUPERIORITY|The threshold for statistical significance was p = 0.05.||||||0.005|||||||ANCOVA|degrees of freedom = 1.||We are reporting the p-value for the group (Growth Mindset vs. Brain Education) by time effect (pre-manipulation and post-manipulation) on fixed emotion mindset scores from time 1 to time 2. This is a test of between by within-subjects interaction effect. Clarity of the psycho-educational lessons included as a covariate.||||0.005
72444682|NCT03978871|144403939|SUPERIORITY|The threshold for statistical significance was p = 0.05.||||||0.033|||||||ANOVA|degrees of freedom = 1.||We are reporting the p-value for the group (Growth Mindset vs. Brain Education) by time effect (pre-manipulation and post-manipulation) on fixed emotion mindset scores from time 1 to time 3. This is a test of between by within-subjects interaction effect.||||.033
72504779|NCT03114969|144540509|SUPERIORITY||Odds Ratio (OR)|3.896|||<|0.001|TWO_SIDED|95.0|2.133|7.118||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta+\[Relvar Ellipta+LAMA\] as comparator.|||7.118|2.133|<0.001
72444683|NCT03978871|144403940|SUPERIORITY|Threshold for statistical significance was p = 0.05||||||0.403|||||||ANOVA|degrees of freedom =1.||We are reporting the p-value for the group (Growth Mindset vs. Brain Education) by time effect (pre-manipulation and post-manipulation) on emotional self-efficacy scores from time 1 to time 2. This is a test of between by within-subjects interaction effect.||||0.403
72444684|NCT03978871|144403940|SUPERIORITY|The threshold for statistical significance was p = 0.05.||||||0.19|||||||ANCOVA|degrees of freedom = 1.||We are reporting the p-value for the group (Growth Mindset vs. Brain Education) by time effect (pre-manipulation and post-manipulation) on emotional self-efficacy scores from time 1 to time 2. This is a test of between by within-subjects interaction effect. Clarity of the psycho-educational lessons was included as a covariate.||||0.190
72444685|NCT03978871|144403941|SUPERIORITY|The threshold for statistical significance was p = 0.05||||||0.784||||||degrees of freedom = 1.|ANOVA|||We are reporting the p-value for the group (Growth Mindset vs. Brain Education) by time effect (pre-manipulation and post-manipulation) on emotional self-efficacy scores from time 1 to time 3. This is a test of between by within-subjects interaction effect.||||0.784
72504780|NCT03114969|144540509|SUPERIORITY||Odds Ratio (OR)|4.777|||<|0.001|TWO_SIDED|95.0|2.508|9.1||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta+\[Relvar Ellipta+LAMA\] as comparator.|||9.100|2.508|<0.001
72504781|NCT03114969|144540510|SUPERIORITY||Odds Ratio (OR)|7.347||||0.176|TWO_SIDED|95.0|0.408|132.143||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.|||132.143|0.408|0.176
72504782|NCT03114969|144540510|SUPERIORITY||Odds Ratio (OR)|9.3||||0.128|TWO_SIDED|95.0|0.526|164.465||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.|||164.465|0.526|0.128
72444686|NCT03978871|144403941|SUPERIORITY|The threshold for statistical significance was p = 0.05.||||||0.586|||||||ANCOVA|degrees of freedom =1.||We are reporting the p-value for the group (Growth Mindset vs. Brain Education) by time effect (pre-manipulation and post-manipulation) on emotional self-efficacy scores from time 1 to time 3. This is a test of between by within-subjects interaction effect. Clarity of the psycho-educational lessons was included as a covariate.||||0.586
72560379|NCT03086135|144651320|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Threshold audiometry at 8000Hz at 12 months with the Osia system vs Unaided at visit 1.||||<0.0001
72560380|NCT03086135|144651321|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Speech in quiet at 50dB at 4 weeks with the Osia system vs Unaided at visit 1.||||<0.0001
72560381|NCT03086135|144651321|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Speech in quiet at 65dB at 4 weeks with the Osia system vs Unaided at visit 1.||||<0.0001
72560382|NCT03086135|144651321|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Speech in quiet at 80dB at 4 weeks with the Osia system vs Unaided at visit 1.||||<0.0001
72560383|NCT03086135|144651321|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Speech in quiet at 50dB at 3 months with the Osia system vs Unaided at visit 1.||||<0.0001
72560384|NCT03086135|144651321|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Speech in quiet at 65dB at 3 months with the Osia system vs Unaided at visit 1.||||<0.0001
72560385|NCT03086135|144651321|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Speech in quiet at 80dB at 3 months with the Osia system vs Unaided at visit 1.||||<0.0001
72560386|NCT03086135|144651321|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Speech in quiet at 50dB at 6 months with the Osia system vs Unaided at visit 1.||||<0.0001
72444687|NCT03978871|144403942|SUPERIORITY|The threshold for statistical significance was p = 0.05.||||||0.916|||||||ANOVA|degrees of freedom = 1.||We are reporting the p-value for the group (Growth Mindset vs. Brain Education) by time effect (pre-manipulation and post-manipulation) on emotional self-efficacy vignette scores from time 1 to time 2. This is a test of between by within-subjects interaction effect.||||0.916
72560387|NCT03086135|144651321|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Speech in quiet at 65dB at 6 months with the Osia system vs Unaided at visit 1.||||<0.0001
72444688|NCT03978871|144403942|SUPERIORITY|The threshold for statistical significance was p = 0.05.||||||0.343|||||||ANCOVA|degrees of freedom =1.||We are reporting the p-value for the group (Growth Mindset vs. Brain Education) by time effect (pre-manipulation and post-manipulation) on emotional self-efficacy vignette scores from time 1 to time 2. This is a test of between by within-subjects interaction effect. Clarity of the psycho-educational lessons was included as a covariate.||||0.343
72560388|NCT03086135|144651321|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Speech in quiet at 80dB at 6 months with the Osia system vs Unaided at visit 1.||||<0.0001
72560389|NCT03086135|144651321|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Speech in quiet at 50dB at 12 months with the Osia system vs Unaided at visit 1.||||<0.0001
72560390|NCT03086135|144651321|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||Speech in quiet at 65dB at 12 months with the Osia system vs Unaided at visit 1.||||<0.0001
72560391|NCT03086135|144651321|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Speech in quiet at 80dB at 12 months with the Osia system vs Unaided at visit 1.||||<0.0001
72560392|NCT03086135|144651322|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Adaptive speech recognition in noise at 4 weeks with the Osia system vs Unaided at visit 1.||||<0.0001
72560393|NCT03086135|144651322|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Adaptive speech recognition in noise at 6 months with the Osia system vs Unaided at visit 1.||||<0.0001
72560394|NCT03086135|144651322|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Adaptive speech recognition in noise at 12 months with the Osia system vs Unaided at visit 1.||||<0.0001
72560395|NCT03086135|144651323|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||APHAB, Ease of communication, at 3 months with the Osia system vs Unaided at visit 1.||||<0.0001
72560396|NCT03086135|144651323|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||APHAB, Background noise, at 3 months with the Osia system vs Unaided at visit 1.||||<0.0001
72560397|NCT03086135|144651323|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||APHAB, Reverberation, at 3 months with the Osia system vs Unaided at visit 1.||||<0.0001
72560398|NCT03086135|144651323|SUPERIORITY|||||||0.51|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||APHAB, Aversiveness, at 3 months with the Osia system vs Unaided at visit 1.||||0.51
72560399|NCT03086135|144651323|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||APHAB, Global score, at 3 months with the Osia system vs Unaided at visit 1.||||<0.0001
72560400|NCT03086135|144651323|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||APHAB, Ease of communication, at 12 months with the Osia system vs Unaided at visit 1.||||<0.0001
72560401|NCT03086135|144651323|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||APHAB, Background noise, at 12 months with the Osia system vs Unaided at visit 1.||||<0.0001
72560402|NCT03086135|144651323|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||APHAB, Reverberation, at 12 months with the Osia system vs Unaided at visit 1.||||<0.0001
72560403|NCT03086135|144651323|SUPERIORITY|||||||0.32|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||APHAB, Aversiveness, at 12 months with the Osia system vs Unaided at visit 1.||||0.32
72560404|NCT03086135|144651323|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||APHAB, Global score, at 12 months with the Osia system vs Unaided at visit 1.||||<0.0001
72560405|NCT03086135|144651324|SUPERIORITY|||||||0.026|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||HUI Comprehensive health state at 3 months with the Osia system vs Unaided at visit 1.||||0.026
72560406|NCT03086135|144651324|SUPERIORITY|||||||0.5|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||HUI Vision attribute at 3 months with the Osia system vs Unaided at visit 1.||||0.50
72444689|NCT03978871|144403943|SUPERIORITY|The threshold for statistical significance was p = 0.05||||||0.048|||||||ANOVA|degrees of freedom = 1.||We are reporting the p-value for the group (Growth Mindset vs. Brain Education) by time effect (pre-manipulation and post-manipulation) on emotional self-efficacy vignette scores from time 1 to time 3. This is a test of between by within-subjects interaction effect.||||0.048
72444690|NCT03978871|144403943|SUPERIORITY|The threshold for statistical significance was p = 0.05.||||||0.153|||||||ANCOVA|degrees of freedom = 1.||We are reporting the p-value for the group (Growth Mindset vs. Brain Education) by time effect (pre-manipulation and post-manipulation) on emotional self-efficacy vignette scores from time 1 to time 3. This is a test of between by within-subjects interaction effect. Clarity of the psycho-educational lesson was included as a covariate.||||0.153
72444691|NCT03978871|144403944|SUPERIORITY|The threshold for statistical significance was p = 0.05.||||||0.566|||||||ANOVA|degrees of freedom =1.||We are reporting the p-value for the group (Growth Mindset vs. Brain Education) by time effect (pre-manipulation and post-manipulation) on ERD proactive engagement scores from time 1 to time 2. This is a test of between by within-subjects interaction effect.||||0.566
72444692|NCT03978871|144403944|SUPERIORITY|The threshold for statistical significance was p = 0.05||||||0.048|||||||ANOVA|degrees of freedom = 1.||We are reporting the p-value for the group (Growth Mindset vs. Brain Education) by time effect (pre-manipulation and post-manipulation) on ERD involuntary dysregulation scores from time 1 to time 2. This is a test of between by within-subjects interaction effect.||||0.048
72444693|NCT03978871|144403944|SUPERIORITY|The threshold for statistical significance was p = 0.05.||||||0.266|||||||ANCOVA|degrees of freedom =1.||We are reporting the p-value for the group (Growth Mindset vs. Brain Education) by time effect (pre-manipulation and post-manipulation) on ERD involuntary dysregulation scores from time 1 to time 2. This is a test of between by within-subjects interaction effect. Clarity of the psycho-educational lessons was included as a covariate.||||0.266
72444694|NCT03978871|144403944|SUPERIORITY|The threshold for statistical significance was p = 0.05.||||||0.402|||||||ANOVA|degrees of freedom =1.||We are reporting the p-value for the group (Growth Mindset vs. Brain Education) by time effect (pre-manipulation and post-manipulation) on ERD disengagement scores from time 1 to time 2. This is a test of between by within-subjects interaction effect.||||0.402
72444695|NCT03978871|144403945|SUPERIORITY|The threshold for statistical significance was p = 0.05.||||||0.363|||||||ANOVA|degrees of freedom =1.||We are reporting the p-value for the group (Growth Mindset vs. Brain Education) by time effect (pre-manipulation and post-manipulation) on ERD proactive engagement from time 1 to time 3. This is a test of between by within-subjects interaction effect.||||0.363
72444696|NCT03978871|144403945|SUPERIORITY|The threshold for statistical significance was p = 0.05||||||0.363|||||||ANOVA|degrees of freedom = 1.||We are reporting the p-value for the group (Growth Mindset vs. Brain Education) by time effect (pre-manipulation and post-manipulation) on ERD involuntary dysregulation scores from time 1 to time 3. This is a test of between by within-subjects interaction effect.||||0.363
72444697|NCT03978871|144403945|SUPERIORITY|The threshold for statistical significance was p = 0.05.||||||0.583|||||||ANCOVA|degrees of freedom = 1.||We are reporting the p-value for the group (Growth Mindset vs. Brain Education) by time effect (pre-manipulation and post-manipulation) on ERD involuntary dysregulation scores from time 1 to time 3. This is a test of between by within-subjects interaction effect. Clarity of the psycho-educational lessons was included as a covariate.||||0.583
72444698|NCT03978871|144403945|SUPERIORITY|The threshold for statistical significance was p = 0.05.||||||0.379|||||||ANOVA|degrees of freedom = 1.||We are reporting the p-value for the group (Growth Mindset vs. Brain Education) by time effect (pre-manipulation and post-manipulation) on ERD disengagement scores from time 1 to time 3. This is a test of between by within-subjects interaction effect.||||0.379
72560407|NCT03086135|144651324|SUPERIORITY|||||||0.0008|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||HUI Hearing attribute, at 3 months with the Osia system vs Unaided at visit 1.||||0.0008
72444699|NCT03978871|144403945|SUPERIORITY|The threshold for statistical significance was p = 0.05.||||||0.246|||||||ANCOVA|degrees of freedom = 1.||We are reporting the p-value for the group (Growth Mindset vs. Brain Education) by time effect (pre-manipulation and post-manipulation) on ERD disengagement scores from time 1 to time 3. This is a test of between by within-subjects interaction effect. Clarity of the psycho-educational lessons was included as a covariate.||||0.246
72444700|NCT03978871|144403946|SUPERIORITY|Data were collected using a Siemens Prisma MRI 3T scanner and preprocessed with fMRIprep. 12 ROI masks were generated from the CON network of a modified Schaefer atlas. First-level contrast estimates (negative reframe \> negative immerse) for each voxel within each ROI were averaged with MarsBaR to produce 12 values for each person. These were then averaged to produce a single value each.A two-sample t-test was conducted in R to test for differences across intervention groups (mindset vs control)||||||0.455||||||The threshold for statistical significance was p \< 0.05.|t-test, 2 sided|t(146) = .75||||||0.455
72444701|NCT03978871|144403947|SUPERIORITY|Data were collected using a Siemens Prisma MRI 3T scanner and preprocessed with fMRIprep. 12 ROI masks were generated from the CON network of a modified Schaefer atlas. First-level contrast estimates (negative \> neutral) for each voxel within each ROI were averaged with MarsBaR to produce 12 values for each person. These were subsequently averaged to produce a single value per person. A two-sample t-test was conducted in R to test for differences across intervention groups (mindset vs control).||||||0.43||||||The threshold for statistical significance was p \< 0.05.|t-test, 2 sided|t(145) = 0.80||||||0.43
72444702|NCT03978871|144403948|SUPERIORITY|BOLD signals were spatially averaged within ROIs to produce a single time series for each ROI. Timeseries were averaged to produce a single value representing each ROI's mean activity. Values for each ROI were then averaged to produce a single value per person representing mean network activity. These values were then submitted to a two-sample t-test to test for differences across intervention groups (mindset vs control).||||||0.29||||||The threshold for statistical significance was p \< 0.05.|t-test, 2 sided|t(142) = -1.057||||||0.29
72444703|NCT03978871|144403949|SUPERIORITY|Data were preprocessed in fMRIprep. Separate right/left amygdala seeds were defined with the AAL1 atlas. Interaction regressors were created between seeds and task conditions. Average contrast estimates for interaction terms of relevant trials (negative reframe \> negative immerse) were extracted with MarsBaR from 12 ROIs in the CON of a modified Schaefer atlas and the 24 values averaged. A two-sample t-test was conducted in R to compare average connectivity between groups (mindset vs control).||||||0.88||||||The threshold for statistical significance was p \< 0.05.|t-test, 2 sided|t(146) = 0.148||||||0.88
72560408|NCT03086135|144651324|SUPERIORITY|||||||0.082|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||HUI Speech attribute, at 3 months with the Osia system vs Unaided at visit 1.||||0.082
72560409|NCT03086135|144651324|SUPERIORITY|||||||0.13|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||HUI Ambulation attribute, at 3 months with the Osia system vs Unaided at visit 1.||||0.13
72560410|NCT03086135|144651324|SUPERIORITY|||||||0.9|TWO_SIDED|95.0|||||Wilcoxon Signed Rank test|||HUI Dexterity attribute, at 3 months with the Osia system vs Unaided at visit 1.||||0.9
72560411|NCT03086135|144651324|SUPERIORITY|||||||0.43|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||HUI Emotion attribute, at 3 months with the Osia system vs Unaided at visit 1.||||0.43
72619221|NCT01655069|144769069|OTHER||Adjusted change from baseline|-1.18|STANDARD_ERROR_OF_MEAN|0.36|||TWO_SIDED|95.0|-1.92|-0.44|||Repeated Measures ANCOVA|Duration of solifenacin treatment: 40 weeks||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant."||-0.44|-1.92|
72619222|NCT01655069|144769069|OTHER||Adjusted change from baseline|-1.79|STANDARD_ERROR_OF_MEAN|0.38|||TWO_SIDED|95.0|-2.59|-1.0|||Repeated Measures ANCOVA|Duration of solifenacin treatment: 52 weeks||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant."||-1.00|-2.59|
72444704|NCT03978871|144403950|SUPERIORITY|Data were preprocessed in fMRIprep. Separate right/left amygdala seeds were defined with the AAL1 atlas. Interaction regressors were created between seeds and task conditions. Average contrast estimates for interaction terms of relevant trials (negative \> neutral) were extracted with MarsBaR from 12 ROIs in the CON of a modified Schaefer atlas and the 24 values averaged. A two-sample t-test was conducted in R to compare average connectivity between groups (mindset vs control).||||||0.11||||||The threshold for statistical significance was p \< 0.05|t-test, 2 sided|t(145) = 1.631||||||.11
72444705|NCT03978871|144403951|SUPERIORITY|BOLD signals were spatially averaged within ROIs to produce a single time series for each ROI. Pearson correlations were calculated between each mean BOLD signal in the CON and each amygdala ROI to produce 24 connectivity values. These were averaged to produce a single value representing the strength of coupling of the CON network to the amygdala for each participant. These values were then submitted to a two-sample t-test to test for differences across intervention groups (mindset vs control).||||||0.92||||||The threshold for statistical significance was p \< 0.05.|t-test, 2 sided|t(142) = 0.101||A two-sample t-test was conducted to compare average connectivity (between the amygdala and the CON network) during resting state between the mindset and control groups.||||0.92
72444706|NCT03978871|144403952|OTHER|Data were preprocessed in fMRIprep. A first-level contrast estimate of interest (negative immerse \> neutral immerse) was submitted to a second-level t-test for group-level differences across experimental conditions (mindset \> control). Monte Carlo simulations using 3dClustSim in AFNI controlled cluster-level family-wise error rate at p \< 0.001 with a cluster-defining threshold of p \< 0.005. The WFU PickAtlas via xjview was used to determine anatomical localization for surviving clusters.||||||2.22e-05||||||Reported result for cluster localized in the Superior/Middle Temporal Gyrus (Right). FWE-corrected p-value is reported. pvoxel-level \< .005, pcluster-level \< .001. Cluster extent = 278 voxels.|t-test, 2 sided|||||||.0000222
72444707|NCT03978871|144403952|SUPERIORITY|Data were preprocessed in fMRIprep. A first-level contrast estimate of interest (negative immerse \> neutral immerse) was submitted to a second-level t-test for group-level differences across experimental conditions (mindset \> control). Monte Carlo simulations using 3dClustSim in AFNI controlled cluster-level family-wise error rate at p \< 0.001 with a cluster-defining threshold of p \< 0.005. The WFU PickAtlas via xjview was used to determine anatomical localization for surviving clusters.||||||1.17e-05||||||Reported result for cluster localized in the Middle Temporal Gyrus (Left). FWE-corrected p-value is reported. pvoxel-level \< .005, pcluster-level \< .001. Cluster extent = 278 voxels.|t-test, 2 sided|||||||.0000117
72560412|NCT03086135|144651324|SUPERIORITY|||||||0.31|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||HUI Cognition attribute, at 3 months with the Osia system vs Unaided at visit 1.||||0.31
72619223|NCT01655069|144769070|OTHER||Adjusted change from baseline|-0.74|STANDARD_ERROR_OF_MEAN|0.46|||TWO_SIDED|95.0|-1.65|0.17|||Repeated Measures ANCOVA|Duration of solifenacin treatment: 3 weeks||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant."||0.17|-1.65|
72560413|NCT03086135|144651324|SUPERIORITY|||||||0.72|TWO_SIDED|95.0|||||Wilcoxon Signed Rank test|||HUI Pain attribute, at 3 months with the Osia system vs Unaided at visit 1.||||0.72
72560414|NCT03086135|144651324|SUPERIORITY|||||||0.13|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||HUI Comprehensive Health State attribute, at 12 months with the Osia system vs Unaided at visit 1.||||0.13
72560415|NCT03086135|144651324|SUPERIORITY|||||||0.23|TWO_SIDED|95.0|||||Wilcoxon Signed Rank test|||HUI Vision attribute, at 12 months with the Osia system vs Unaided at visit 1.||||0.23
72560416|NCT03086135|144651324|SUPERIORITY|||||||0.0026|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||HUI Hearing attribute, at 12 months with the Osia system vs Unaided at visit 1.||||0.0026
72560417|NCT03086135|144651324|SUPERIORITY|||||||0.0024|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||HUI Speech attribute, at 12 months with the Osia system vs Unaided at visit 1.||||0.0024
72560418|NCT03086135|144651324|SUPERIORITY|||||||0.16|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||HUI Ambulation attribute, at 12 months with the Osia system vs Unaided at visit 1.||||0.16
72560419|NCT03086135|144651324|SUPERIORITY|||||||0.16|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||HUI Dexterity attribute, at 12 months with the Osia system vs Unaided at visit 1.||||0.16
72560420|NCT03086135|144651324|SUPERIORITY|||||||0.85|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||HUI Emotion attribute, at 12 months with the Osia system vs Unaided at visit 1.||||0.85
72560421|NCT03086135|144651324|SUPERIORITY|||||||1|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||HUI Cognition attribute, at 12 months with the Osia system vs Unaided at visit 1.||||1.0
72560422|NCT03086135|144651324|SUPERIORITY|||||||0.56|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||HUI Pain attribute, at 12 months with the Osia system vs Unaided at visit 1.||||0.56
72560423|NCT03086135|144651325|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||SSQ Total score at 3 months with the Osia system vs Unaided at visit 1.||||<0.0001
72619224|NCT01655069|144769070|OTHER||Adjusted change from baseline|-1.3|STANDARD_ERROR_OF_MEAN|0.47|||TWO_SIDED|95.0|-2.23|-0.36|||Repeated Measures ANCOVA|Duration of solifenacin treatment: 6 weeks||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant."||-0.36|-2.23|
72444708|NCT03978871|144403952|SUPERIORITY|Data were preprocessed in fMRIprep. A first-level contrast estimate of interest (negative immerse \> neutral immerse) was submitted to a second-level t-test for group-level differences across experimental conditions (mindset \> control). Monte Carlo simulations using 3dClustSim in AFNI controlled cluster-level family-wise error rate at p \< 0.001 with a cluster-defining threshold of p \< 0.005. The WFU PickAtlas via xjview was used to determine anatomical localization for surviving clusters.||||||0||||||"Reported result for cluster localized in the Anterior Cingulate/Medial Frontal Gyrus.~FWE-corrected p-value is reported. pvoxel-level \< .005, pcluster-level \< .001. Cluster extent = 278 voxels."|t-test, 2 sided|||||||.000000000
72444709|NCT03978871|144403952|SUPERIORITY|Data were preprocessed in fMRIprep. A first-level contrast estimate of interest (negative immerse \> neutral immerse) was submitted to a second-level t-test for group-level differences across experimental conditions (mindset \> control). Monte Carlo simulations using 3dClustSim in AFNI controlled cluster-level family-wise error rate at p \< 0.001 with a cluster-defining threshold of p \< 0.005. The WFU PickAtlas via xjview was used to determine anatomical localization for surviving clusters.||||||1.86e-05||||||Reported result for cluster localized in the Middle Frontal Gyrus (Right). FWE-corrected p-value is reported. pvoxel-level \< .005, pcluster-level \< .001. Cluster extent = 278 voxels.|t-test, 2 sided|||||||.0000186
72444710|NCT03978871|144403952|SUPERIORITY|Data were preprocessed in fMRIprep. A first-level contrast estimate of interest (negative immerse \> neutral immerse) was submitted to a second-level t-test for group-level differences across experimental conditions (mindset \> control). Monte Carlo simulations using 3dClustSim in AFNI controlled cluster-level family-wise error rate at p \< 0.001 with a cluster-defining threshold of p \< 0.005. The WFU PickAtlas via xjview was used to determine anatomical localization for surviving clusters.||||||0||||||Reported result for cluster localized in the Middle Frontal Gyrus (Left). FWE-corrected p-value is reported. pvoxel-level \< .005, pcluster-level \< .001. Cluster extent = 278 voxels.|t-test, 2 sided|||||||.000000000
72444711|NCT03978871|144403952|SUPERIORITY|Data were preprocessed in fMRIprep. A first-level contrast estimate of interest (negative immerse \> neutral immerse) was submitted to a second-level t-test for group-level differences across experimental conditions (mindset \> control). Monte Carlo simulations using 3dClustSim in AFNI controlled cluster-level family-wise error rate at p \< 0.001 with a cluster-defining threshold of p \< 0.005. The WFU PickAtlas via xjview was used to determine anatomical localization for surviving clusters.||||||1.61e-05||||||Reported result for cluster localized in the Posterior Cingulate/Cingulate. FWE-corrected p-value is reported. pvoxel-level \< .005, pcluster-level \< .001. Cluster extent = 278 voxels.|t-test, 2 sided|||||||.0000161
72444712|NCT03978871|144403952|OTHER|Data were preprocessed in fMRIprep. A first-level contrast estimate of interest (negative reframe \> negative immerse) was submitted to a second-level t-test for group-level differences across experimental conditions (mindset \> control). Monte Carlo simulations using 3dClustSim in AFNI controlled cluster-level family-wise error rate at p \< 0.001 with a cluster-defining threshold of p \< 0.005.|||||>|0.001||||||pvoxel-level \< .005, pcluster-level \< .001. Cluster extent = 298 voxels.|t-test, 2 sided|||||||>.001
72444713|NCT03978871|144403953|SUPERIORITY|The threshold for statistical significance was p = 0.05.||||||0.56|||||||ANOVA|degrees of freedom = 1.||We are reporting the p-value for the group (Growth Mindset vs. Brain Education) by time effect (baseline and follow-up) on depression levels from time 1 to time 2. This is a test of between by within-subjects interaction effect.||||0.560
72444714|NCT03978871|144403954|SUPERIORITY|The threshold for statistical significance was p = 0.05.||||||0.327|||||||ANOVA|degrees of freedom = 1.||We are reporting the p-value for the group (Growth Mindset vs. Brain Education) by time effect (baseline and follow-up) on depression levels from time 1 to time 3. This is a test of between by within-subjects interaction effect.||||0.327
72560424|NCT03086135|144651325|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||SSQ Speech score at 3 months with the Osia system vs Unaided at visit 1.||||<0.0001
72444715|NCT03978871|144403955|SUPERIORITY|The threshold for statistical significance was p = 0.05.||||||0.439|||||||ANOVA|degrees of freedom = 1.||We are reporting the p-value for the group (Growth Mindset vs. Brain Education) by time effect (baseline and follow-up) on anxiety levels from time 1 to time 2. This is a test of between by within-subjects interaction effect.||||0.439
72444716|NCT03978871|144403955|SUPERIORITY|The threshold for statistical significance was p = 0.05.||||||0.545|||||||ANCOVA|degrees of freedom = 1.||We are reporting the p-value for the group (Growth Mindset vs. Brain Education) by time effect (baseline and follow-up) on anxiety levels from time 1 to time 2. This is a test of between by within-subjects interaction effect. Clarity of the psycho-educational lessons was included as a covariate.||||0.545
72560425|NCT03086135|144651325|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||SSQ Spatial score at 3 months with the Osia system vs Unaided at visit 1.||||<0.0001
72560426|NCT03086135|144651325|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||SSQ Quality score at 3 months with the Osia system vs Unaided at visit 1.||||<0.0001
72560427|NCT03086135|144651325|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||SSQ Total score at 12 months with the Osia system vs Unaided at visit 1.||||<0.0001
72560428|NCT03086135|144651325|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||SSQ Speech score at 12 months with the Osia system vs Unaided at visit 1.||||<0.0001
72444717|NCT03978871|144403956|SUPERIORITY|The threshold for statistical significance was p = 0.05.||||||0.74|||||||ANOVA|degrees of freedom = 1.||We are reporting the p-value for the group (Growth Mindset vs. Brain Education) by time effect (baseline and follow-up) on anxiety levels from time 1 to time 3. This is a test of between by within-subjects interaction effect.||||0.740
72444718|NCT04391894|144403982|SUPERIORITY||Least Squares Mean (LS Mean)|-1.1|STANDARD_ERROR_OF_MEAN|2.01||0.585|TWO_SIDED|95.0|-5.0|2.8|||Mixed Models Analysis|||||2.8|-5.0|0.585
72444719|NCT04391894|144403982|SUPERIORITY||Least Squares Mean (LS Mean)|-3.2|STANDARD_ERROR_OF_MEAN|2.0||0.107|TWO_SIDED|95.0|-7.01|0.7|||Mixed Models Analysis|||||0.7|-7.01|0.107
72444720|NCT04391894|144403982|SUPERIORITY||Least Squares Mean (LS Mean)|4.3|STANDARD_ERROR_OF_MEAN|2.02||0.033|TWO_SIDED|95.0|0.3|8.3|||Mixed Models Analysis|||||8.3|0.3|0.033
72444721|NCT04391894|144403983|SUPERIORITY||Least Squares Mean (LS Mean)|-0.2|STANDARD_ERROR_OF_MEAN|0.31||0.605|TWO_SIDED|95.0|-0.8|0.4|||Mixed Models Analysis|||||0.4|-0.8|0.605
72444722|NCT04391894|144403983|SUPERIORITY||Least Squares Mean (LS Mean)|-0.1|STANDARD_ERROR_OF_MEAN|0.31||0.646|TWO_SIDED|95.0|-0.7|0.5|||Mixed Models Analysis|||||0.5|-0.7|0.646
72444723|NCT04391894|144403983|SUPERIORITY||Least Squares Mean (LS Mean)|0.1|STANDARD_ERROR_OF_MEAN|0.31||0.847|TWO_SIDED|95.0|-0.5|0.7|||Mixed Models Analysis|||||0.7|-0.5|0.847
72444724|NCT04391894|144403984|SUPERIORITY||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|0.11|||TWO_SIDED|95.0|-0.2|0.2||||||||0.2|-0.2|
72444725|NCT04391894|144403984|SUPERIORITY||Mean Difference (Net)|-0.1|STANDARD_ERROR_OF_MEAN|0.11|||TWO_SIDED|95.0|-0.3|0.1||||||||0.1|-0.3|
72560429|NCT03086135|144651325|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||SSQ Spatial score at 12 months with the Osia system vs Unaided at visit 1.||||<0.0001
72444726|NCT04391894|144403984|SUPERIORITY||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|0.09|||TWO_SIDED|95.0|-0.2|0.2||||||||0.2|-0.2|
72444727|NCT04391894|144403985|SUPERIORITY||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|0.11|||TWO_SIDED|95.0|-0.2|0.2||||||||0.2|-0.2|
72444728|NCT04391894|144403985|SUPERIORITY||Mean Difference (Net)|-0.1|STANDARD_ERROR_OF_MEAN|0.12|||TWO_SIDED|95.0|-0.3|0.1||||||||0.1|-0.3|
72444729|NCT04391894|144403985|SUPERIORITY||Mean Difference (Net)|0.4|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|0.1|0.6||||||||0.6|0.1|
72444730|NCT02323321|144403987|OTHER|The primary hypothesis for this study is that the true (success) proportion of transplanted patients meeting the primary effectiveness endpoint, patient survival at day 30 post-transplantation and absence of severe PGD (left or right ventricle) in the first 24 hours post-transplantation, is greater than the Performance Goal value of 0.65.|Proportion|88.0|||<|0.0001|TWO_SIDED|95.0|78.4|94.4|||one-sided exact binomial test|||||94.4|78.4|<0.0001
72444731|NCT00446225|144403988|SUPERIORITY||Hazard Ratio (HR)|0.42||||0.0001|TWO_SIDED|95.0|0.27|0.64|||Log Rank|||||0.64|0.27|0.0001
72444732|NCT00446225|144403990|SUPERIORITY||Hazard Ratio (HR)|0.59||||0.043|TWO_SIDED|95.0|0.36|0.99|||Log Rank|||||0.99|0.36|0.043
72444733|NCT03526874|144404028|SUPERIORITY|||||||0.013|||||||t-test, 2 sided|||||||0.013
72444734|NCT03526874|144404029|SUPERIORITY|||||||0.031|||||||t-test, 2 sided|||||||0.031
72444735|NCT03526874|144404030|SUPERIORITY|||||||0.0162|||||||ANOVA|Two-way Anova to test sex interaction with treatment effect. The study was not powered for subgroup analyses.||||||0.0162
72444736|NCT03526874|144404031|SUPERIORITY|||||||0.04||||||Two-way Anova to test sex interaction with treatment effect. The study was not powered for subgroup analyses.|ANOVA|||||||0.04
72444737|NCT03526874|144404032|SUPERIORITY|||||||0.0098|||||||ANOVA|Two-way Anova to test ethnicity interaction with treatment effect. The study was not powered for subgroup analyses.||||||0.0098
72444738|NCT03526874|144404033|SUPERIORITY|||||||0.02|||||||ANOVA|Two-way Anova to test ethnicity interaction with treatment effect. The study was not powered for subgroup analyses.||||||0.02
72444739|NCT03526874|144404034|SUPERIORITY|||||||0.01|||||||ANOVA|Two-way Anova to test race interaction with treatment effect. The study was not powered for subgroup analyses.||||||0.01
72444740|NCT03526874|144404035|SUPERIORITY|||||||0.0329|||||||ANOVA|Two-way Anova to test race interaction with treatment effect. The study was not powered for subgroup analyses.||||||0.0329
72444741|NCT03526874|144404036|SUPERIORITY|||||||0.294|||||||t-test, 2 sided|||||||0.294
72444742|NCT03526874|144404037|SUPERIORITY|||||||0.058|||||||t-test, 2 sided|||||||0.058
72444743|NCT03526874|144404038|SUPERIORITY|||||||0.182|||||||t-test, 2 sided|||||||0.182
72444744|NCT03526874|144404039|SUPERIORITY|||||||0.423|||||||Fisher Exact|||||||0.423
72444745|NCT03526874|144404040|SUPERIORITY|||||||0.03|||||||Chi-squared|||||||0.030
72444746|NCT03526874|144404041|SUPERIORITY|||||||0.112|||||||Fisher Exact|||||||0.112
72444747|NCT03526874|144404042|SUPERIORITY|||||||0.052|||||||Fisher Exact|||||||0.052
72444748|NCT03526874|144404043|SUPERIORITY|||||||0.027|||||||Chi-squared|||||||0.027
72560430|NCT03086135|144651325|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||SSQ Quality score at 12 months with the Osia system vs Unaided at visit 1.||||<0.0001
72560431|NCT03086135|144651326|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Hearing performance: threshold audiometry PTA4 with Osia at 4 week vs the reference device BP110 on a softband at visit 1.||||<0.0001
72560432|NCT03086135|144651326|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Hearing performance: threshold audiometry PTA4 with Osia at 3 months vs the reference device BP110 on a softband at visit 1.||||<0.0001
72560433|NCT03086135|144651326|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Hearing performance: threshold audiometry PTA4 with Osia at 6 months vs the reference device BP110 on a softband at visit 1.||||<0.0001
72560434|NCT03086135|144651326|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Hearing performance: threshold audiometry PTA4 with Osia at 12 months vs the reference device BP110 on a softband at visit 1.||||<0.0001
72560435|NCT03086135|144651327|SUPERIORITY|||||||0.025|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Hearing performance: threshold audiometry 250Hz with Osia at 4 week vs the reference device BP110 on a softband at visit 1.||||0.025
72560436|NCT03086135|144651327|SUPERIORITY|||||||0.096|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Hearing performance: threshold audiometry 500Hz with Osia at 4 week vs the reference device BP110 on a softband at visit 1.||||0.096
72560437|NCT03086135|144651327|SUPERIORITY|||||||0.015|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Hearing performance: threshold audiometry 750Hz with Osia at 4 week vs the reference device BP110 on a softband at visit 1.||||0.015
72560438|NCT03086135|144651327|SUPERIORITY|||||||0.67|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Hearing performance: threshold audiometry 1000Hz with Osia at 4 week vs the reference device BP110 on a softband at visit 1.||||0.67
72619225|NCT01655069|144769070|OTHER||Adjusted change from baseline|-1.14|STANDARD_ERROR_OF_MEAN|0.47|||TWO_SIDED|95.0|-2.06|-0.22|||Repeated Measures ANCOVA|Duration of solifenacin treatment: 9 weeks||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant."||-0.22|-2.06|
72497300|NCT00542620|144524473|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was considered confirmed if the upper bound of the two-sided 95% confidence interval was below or equal to 0.25% or equivalently if the p-value for the one-sided test of H0: D\>0.25% against HA: D=\<0.25%, was less than or equal to 2.5%, where D is the mean treatment difference (mixing injections minus separate injections).|Median Difference (Final Values)|-0.691||||0.001||95.0|-1.049|-0.334||If non-inferiority was confirmed, the superiority of the mixed injection group over separate injection group was to be investigated|ANCOVA|Baseline HbA1c as covariate||||-0.334|-1.049|0.001
72560439|NCT03086135|144651327|SUPERIORITY|||||||0.73|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Hearing performance: threshold audiometry 1500Hz with Osia at 4 week vs the reference device BP110 on a softband at visit 1.||||0.73
72619226|NCT01655069|144769070|OTHER||Adjusted change from baseline|-1.28|STANDARD_ERROR_OF_MEAN|0.46|||TWO_SIDED|95.0|-2.18|-0.38|||Repeated Measures ANCOVA|Duration of solifenacin treatment: 12 weeks||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant."||-0.38|-2.18|
72560440|NCT03086135|144651327|SUPERIORITY|||||||0.019|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Hearing performance: threshold audiometry 2000Hz with Osia at 4 week vs the reference device BP110 on a softband at visit 1.||||0.019
72560441|NCT03086135|144651327|SUPERIORITY|||||||0.0046|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Hearing performance: threshold audiometry 3000Hz with Osia at 4 week vs the reference device BP110 on a softband at visit 1.||||0.0046
72560442|NCT03086135|144651327|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Hearing performance: threshold audiometry 4000Hz with Osia at 4 week vs the reference device BP110 on a softband at visit 1.||||<0.0001
72560443|NCT03086135|144651327|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Hearing performance: threshold audiometry 6000Hz with Osia at 4 week vs the reference device BP110 on a softband at visit 1.||||<0.0001
72560444|NCT03086135|144651327|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Hearing performance: threshold audiometry 8000Hz with Osia at 4 week vs the reference device BP110 on a softband at visit 1.||||<0.0001
72560445|NCT03086135|144651327|SUPERIORITY|||||||0.019|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Hearing performance: threshold audiometry 250Hz with Osia at 3 months vs the reference device BP110 on a softband at visit 1.||||0.019
72560446|NCT03086135|144651327|SUPERIORITY|||||||0.04|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Hearing performance: threshold audiometry 500Hz with Osia at 3 months vs the reference device BP110 on a softband at visit 1.||||0.040
72560447|NCT03086135|144651327|SUPERIORITY|||||||0.037|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Hearing performance: threshold audiometry 750Hz with Osia at 3 months vs the reference device BP110 on a softband at visit 1.||||0.037
72560448|NCT03086135|144651327|SUPERIORITY|||||||0.67|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Hearing performance: threshold audiometry 1000Hz with Osia at 3 months vs the reference device BP110 on a softband at visit 1.||||0.67
72560449|NCT03086135|144651327|SUPERIORITY|||||||0.34|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Hearing performance: threshold audiometry 1500Hz with Osia at 3 months vs the reference device BP110 on a softband at visit 1.||||0.34
72560450|NCT03086135|144651327|SUPERIORITY|||||||0.0048|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Hearing performance: threshold audiometry 2000Hz with Osia at 3 months vs the reference device BP110 on a softband at visit 1.||||0.0048
72560451|NCT03086135|144651327|SUPERIORITY|||||||0.0008|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Hearing performance: threshold audiometry 3000Hz with Osia at 3 months vs the reference device BP110 on a softband at visit 1.||||0.0008
72444757|NCT04986501|144404104|SUPERIORITY||||||<|0.01|||||||t-test, 1 sided|||||||<0.01
72444758|NCT04986501|144404106|SUPERIORITY||||||<|0.01|||||||t-test, 1 sided|||||||<0.01
72444759|NCT03964350|144404109|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<.05
72444760|NCT04402489|144404124|SUPERIORITY||Least Square Mean Difference vs Placebo|9.8|STANDARD_ERROR_OF_MEAN|14.35||0.496|TWO_SIDED|95.0|-18.52|38.12|||Mixed-effect model for repeated measures|||Change from BL at Week 26 (DBT EOT) - lower dose||38.12|-18.52|0.496
72444761|NCT04402489|144404124|SUPERIORITY||Least Square Mean Difference vs Placebo|22.7|STANDARD_ERROR_OF_MEAN|14.38||0.116|TWO_SIDED|95.0|-5.68|51.09|||Mixed-effect model for repeated measures|||Change from BL at Week 26 (DBT EOT) - higher dose||51.09|-5.68|0.116
72444762|NCT04402489|144404125|SUPERIORITY||Least Square Mean Difference vs Placebo|-0.84|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|-1.23|-0.44|||Mixed-effect model for repeated measures|||||-0.44|-1.23|< 0.001
72497301|NCT00542620|144524474|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was considered confirmed if the upper bound of the two-sided 95% confidence interval was below or equal to 0.25% or equivalently if the p-value for the one-sided test of H0: D\>0.25% against HA: D=\<0.25%, was less than or equal to 2.5%, where D is the mean treatment difference (mixing injections minus separate injections).|Mean Difference (Final Values)|-0.594||||0.003||95.0|-0.97|-0.219||If non-inferiority was confirmed, the superiority of the mixed injection group over separate injection group was to be investigated.|ANCOVA|Baseline HbA1c as covariate.||||-0.219|-0.970|0.003
72497302|NCT00542620|144524475|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.35|STANDARD_ERROR_OF_MEAN|14.59||0.573||95.0|-38.77|22.08|||ANCOVA|With adjustment on baseline fructosamine and the change in insulin administration mode||||22.08|-38.77|0.573
72619227|NCT01655069|144769070|OTHER||Adjusted change from baseline|-1.04|STANDARD_ERROR_OF_MEAN|0.46|||TWO_SIDED|95.0|-1.95|-0.12|||Repeated Measures ANCOVA|Duration of solifenacin treatment: 24 weeks||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant"||-0.12|-1.95|
72444763|NCT04402489|144404125|SUPERIORITY||Least Square Mean Difference vs Placebo|-1.43|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|-1.83|-1.03|||Mixed-effect model for repeated measures|||||-1.03|-1.83|< 0.001
72497303|NCT00542620|144524476|SUPERIORITY_OR_OTHER|||||||0.063|||||||ANCOVA|With adjustment on baseline value||||||0.063
72560452|NCT03086135|144651327|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Hearing performance: threshold audiometry 4000Hz with Osia at 3 months vs the reference device BP110 on a softband at visit 1.||||<0.0001
72560453|NCT03086135|144651327|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||Hearing performance: threshold audiometry 6000Hz with Osia at 3 months vs the reference device BP110 on a softband at visit 1.||||<0.0001
72560454|NCT03086135|144651327|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Hearing performance: threshold audiometry 8000Hz with Osia at 3 months vs the reference device BP110 on a softband at visit 1.||||<0.0001
72444764|NCT04402489|144404126|SUPERIORITY|Negative binomial regression model with log link was used.|Incident rate ratio|0.76||||0.199|TWO_SIDED|95.0|0.49|1.16|||Refer to comments below:|Negative binomial regression model with log link was used for other method.||||1.16|0.49|0.199
72444765|NCT04402489|144404126|SUPERIORITY|Negative binomial regression model with log link was used.|Incident rate ratio|0.55||||0.006|TWO_SIDED|95.0|0.36|0.84|||Refer to comments below:|Negative binomial regression model with log link was used for other method.||||0.84|0.36|0.006
72444766|NCT04402489|144404127|SUPERIORITY||Least Square Mean Difference vs Placebo|-0.15|STANDARD_ERROR_OF_MEAN|0.24||0.55|TWO_SIDED|95.0|-0.62|0.33|||mixed-effect model for repeated measures|||||0.33|-0.62|0.55
72444767|NCT04402489|144404127|SUPERIORITY||Least Square Mean Difference vs Placebo|-0.23|STANDARD_ERROR_OF_MEAN|0.25||0.343|TWO_SIDED|95.0|-0.72|0.25|||mixed-effect model for repeated measures|||||0.25|-0.72|0.343
72444768|NCT04402489|144404128|SUPERIORITY||Odds Ratio (OR)|0.805||||0.642|TWO_SIDED|95.0|0.323|2.007|||Regression, Logistic|||||2.007|0.323|0.642
72444769|NCT04402489|144404128|SUPERIORITY||Odds Ratio (OR)|1.412||||0.431|TWO_SIDED|95.0|0.598|3.336|||Regression, Logistic|||||3.336|0.598|0.431
72444770|NCT04402489|144404129|SUPERIORITY||Least Square Mean Difference vs Placebo|0.87|STANDARD_ERROR_OF_MEAN|0.48||0.072|TWO_SIDED|95.0|-0.08|1.82|||mixed-effect model for repeated measures|||||1.82|-0.08|0.072
72444771|NCT04402489|144404129|SUPERIORITY||Least Square Mean Difference vs Placebo|0.56|STANDARD_ERROR_OF_MEAN|0.48||0.252|TWO_SIDED|95.0|-0.4|1.51|||mixed-effect model for repeated measures|||||1.51|-0.4|0.252
72444772|NCT05902793|144404130|NON_INFERIORITY|the non-inferiority margin is 20%|least square means difference|0.89|||||TWO_SIDED|95.0|-14.3|16.07|||||To establish non-inferiority the lower limit of the least square mean difference had to be \> -20%.|||16.07|-14.30|
72444773|NCT05902793|144404132|SUPERIORITY|||||||0.24|||||||ANCOVA|ANCOVA model had fixed effects of treatment arm, center and wound size||||||0.24
72560455|NCT03086135|144651327|SUPERIORITY|||||||0.1|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Hearing performance: threshold audiometry 250Hz with Osia at 6 months vs the reference device BP110 on a softband at visit 1.||||0.10
72444774|NCT03854578|144404153|OTHER|ANOVA model with treatment (BI 1358894 versus placebo) and severity of depression (MontgomeryÅsberg Depression Rating Scale (MADRS) ≥20 versus \<20) as fixed effects. The Citalopram treatment arm was used as a positive control group. It was not planned to compare pharmacodynamic effects between Citalopram and BI 1358894.|Mean change|-0.08|STANDARD_ERROR_OF_MEAN|0.03||0.0105|TWO_SIDED|90.0|-0.14|-0.03|||ANOVA||Mean change calculated as: BI - Placebo.|Mean BOLD signal % change/ Amygdala Left||-0.03|-0.14|0.0105
72560456|NCT03086135|144651327|SUPERIORITY|||||||0.0007|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Hearing performance: threshold audiometry 500Hz with Osia at 6 months vs the reference device BP110 on a softband at visit 1.||||0.0007
72560457|NCT03086135|144651327|SUPERIORITY|||||||0.0003|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Hearing performance: threshold audiometry 750Hz with Osia at 6 months vs the reference device BP110 on a softband at visit 1.||||0.0003
72560458|NCT03086135|144651327|SUPERIORITY|||||||0.11|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Hearing performance: threshold audiometry 1000Hz with Osia at 6 months vs the reference device BP110 on a softband at visit 1.||||0.11
72560459|NCT03086135|144651327|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Hearing performance: threshold audiometry 1500Hz with Osia at 6 months vs the reference device BP110 on a softband at visit 1.||||<0.0001
72560460|NCT03086135|144651327|SUPERIORITY|||||||0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Hearing performance: threshold audiometry 2000Hz with Osia at 6 months vs the reference device BP110 on a softband at visit 1.||||0.0001
72560461|NCT03086135|144651327|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Hearing performance: threshold audiometry 3000Hz with Osia at 6 months vs the reference device BP110 on a softband at visit 1.||||<0.0001
72560462|NCT03086135|144651327|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Hearing performance: threshold audiometry 4000Hz with Osia at 6 months vs the reference device BP110 on a softband at visit 1.||||<0.0001
72560463|NCT03086135|144651327|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Hearing performance: threshold audiometry 6000Hz with Osia at 6 months vs the reference device BP110 on a softband at visit 1.||||<0.0001
72560464|NCT03086135|144651327|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Hearing performance: threshold audiometry 8000Hz with Osia at 6 months vs the reference device BP110 on a softband at visit 1.||||<0.0001
72560465|NCT03086135|144651327|SUPERIORITY|||||||0.8|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Hearing performance: threshold audiometry 250Hz with Osia at 12 months vs the reference device BP110 on a softband at visit 1.||||0.80
72560466|NCT03086135|144651327|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Hearing performance: threshold audiometry 500Hz with Osia at 12 months vs the reference device BP110 on a softband at visit 1.||||<0.0001
72560467|NCT03086135|144651327|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Hearing performance: threshold audiometry 750Hz with Osia at 12 months vs the reference device BP110 on a softband at visit 1.||||<0.0001
72560468|NCT03086135|144651327|SUPERIORITY|||||||0.001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Hearing performance: threshold audiometry 1000Hz with Osia at 12 months vs the reference device BP110 on a softband at visit 1.||||0.0010
72560469|NCT03086135|144651327|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Hearing performance: threshold audiometry 1500Hz with Osia at 12 months vs the reference device BP110 on a softband at visit 1.||||<0.0001
72560470|NCT03086135|144651327|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Hearing performance: threshold audiometry 2000Hz with Osia at 12 months vs the reference device BP110 on a softband at visit 1.||||<0.0001
72560471|NCT03086135|144651327|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Hearing performance: threshold audiometry 3000Hz with Osia at 12 months vs the reference device BP110 on a softband at visit 1.||||<0.0001
72560472|NCT03086135|144651327|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Hearing performance: threshold audiometry 4000Hz with Osia at 12 months vs the reference device BP110 on a softband at visit 1.||||<0.0001
72560473|NCT03086135|144651327|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Hearing performance: threshold audiometry 6000Hz with Osia at 12 months vs the reference device BP110 on a softband at visit 1.||||<0.0001
72560474|NCT03086135|144651327|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Hearing performance: threshold audiometry 8000Hz with Osia at 12 months vs the reference device BP110 on a softband at visit 1.||||<0.0001
72560475|NCT03086135|144651328|SUPERIORITY|||||||0.51|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Speech in quiet at 50dB SPL with Osia at 4 weeks vs reference device BP110 on softband att visit 1.||||0.51
72560476|NCT03086135|144651328|SUPERIORITY|||||||0.021|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Speech in quiet at 65dB SPL with Osia at 4 weeks vs reference device BP110 on softband att visit 1.||||0.021
72560477|NCT03086135|144651328|SUPERIORITY|||||||0.29|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Speech in quiet at 80dB SPL with Osia at 4 weeks vs reference device BP110 on softband att visit 1.||||0.29
72560478|NCT03086135|144651328|SUPERIORITY|||||||0.18|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Speech in quiet at 50dB SPL with Osia at 3 months vs reference device BP110 on softband att visit 1.||||0.18
72444775|NCT03854578|144404153|OTHER|ANOVA model with treatment (BI 1358894 versus placebo) and severity of depression (MADRS ≥20 versus \<20) as fixed effects. The Citalopram treatment arm was used as a positive control group. It was not planned to compare pharmacodynamic effects between Citalopram and BI 1358894.|Mean change|-0.08|STANDARD_ERROR_OF_MEAN|0.03||0.0134|TWO_SIDED|90.0|-0.14|-0.03|||ANOVA||Mean change calculated as: BI - Placebo.|Mean BOLD signal % change/ Amygdala Right||-0.03|-0.14|0.0134
72497304|NCT00542620|144524477|SUPERIORITY_OR_OTHER|||||||0.389|||||||ANCOVA|With adjustment on baseline value||||||0.389
72497305|NCT00542620|144524478|SUPERIORITY_OR_OTHER|||||||0.856|||||||ANCOVA|With adjustment on baseline value||||||0.856
72497306|NCT00542620|144524479|SUPERIORITY_OR_OTHER|||||||0.917|||||||ANCOVA|With adjustment on baseline value||||||0.917
72497307|NCT00542620|144524480|SUPERIORITY_OR_OTHER|||||||0.209|||||||ANCOVA|With adjustment on baseline value||||||0.209
72497308|NCT00542620|144524481|SUPERIORITY_OR_OTHER|||||||0.22|||||||ANCOVA|With adjustment on baseline value||||||0.220
72497309|NCT00542620|144524482|SUPERIORITY_OR_OTHER|||||||0.234|||||||ANCOVA|With adjustment for baseline value||||||0.234
72497310|NCT00542620|144524483|SUPERIORITY_OR_OTHER|||||||0.534|||||||ANCOVA|With adjustment on baseline value||||||0.534
72560479|NCT03086135|144651328|SUPERIORITY|||||||0.017|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Speech in quiet at 65dB SPL with Osia at 3 months vs reference device BP110 on softband att visit 1.||||0.017
72560480|NCT03086135|144651328|SUPERIORITY|||||||0.16|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Speech in quiet at 80dB SPL with Osia at 3 months vs reference device BP110 on softband att visit 1.||||0.16
72560481|NCT03086135|144651328|SUPERIORITY|||||||0.0051|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Speech in quiet at 50dB SPL with Osia at 6 months vs reference device BP110 on softband att visit 1.||||0.0051
72560482|NCT03086135|144651328|SUPERIORITY|||||||0.021|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Speech in quiet at 65dB SPL with Osia at 6 months vs reference device BP110 on softband att visit 1.||||0.021
72560483|NCT03086135|144651328|SUPERIORITY|||||||0.56|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Speech in quiet at 80dB SPL with Osia at 6 months vs reference device BP110 on softband att visit 1.||||0.56
72560484|NCT03086135|144651328|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Speech in quiet at 50dB SPL with Osia at 12 months vs reference device BP110 on softband att visit 1.||||<0.0001
72560485|NCT03086135|144651328|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Speech in quiet at 65dB SPL with Osia at 12 months vs reference device BP110 on softband att visit 1.||||<0.0001
72560486|NCT03086135|144651328|SUPERIORITY|||||||0.041|TWO_SIDED|95.0|||||Wilcoxon Signed Rank test|||Speech in quiet at 80dB SPL with Osia at 12 months vs reference device BP110 on softband att visit 1.||||0.041
72560487|NCT03086135|144651329|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Adaptive Speech Recognition in Noise with Osia at 4 weeks vs reference device BP110 on softband at visit 1.||||<0.0001
72560488|NCT03086135|144651329|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Adaptive Speech Recognition in Noise with Osia at 3 months vs reference device BP110 on softband at visit 1.||||<0.0001
72497311|NCT00542620|144524484|SUPERIORITY_OR_OTHER|||||||0.722|||||||ANCOVA|With adjustment on baseline value||||||0.722
72497312|NCT00542620|144524485|SUPERIORITY_OR_OTHER|||||||0.727|||||||ANCOVA|With adjustment on baseline value||||||0.727
72560489|NCT03086135|144651329|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Adaptive Speech Recognition in Noise with Osia at 6 months vs reference device BP110 on softband at visit 1.||||<0.0001
72560490|NCT03086135|144651329|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Adaptive Speech Recognition in Noise with Osia at 12 months vs reference device BP110 on softband at visit 1.||||<0.0001
72619228|NCT01655069|144769070|OTHER||Adjusted change from baseline|-1.96|STANDARD_ERROR_OF_MEAN|0.49|||TWO_SIDED|95.0|-2.93|-1.0|||Repeated Measures ANCOVA|Duration of solifenacin treatment: 40 weeks||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant."||-1.00|-2.93|
72497313|NCT00542620|144524486|SUPERIORITY_OR_OTHER|||||||0.411|||||||ANCOVA|With adjustment on baseline value||||||0.411
72497314|NCT00542620|144524487|SUPERIORITY_OR_OTHER|||||||0.471|||||||ANCOVA|With adjustment on baseline value||||||0.471
72497315|NCT00542620|144524490|SUPERIORITY_OR_OTHER|||||||0.127|||||||ANCOVA|With adjustment on baseline value||||||0.127
72497316|NCT00542620|144524491|SUPERIORITY_OR_OTHER|||||||0.1|||||||ANCOVA|With adjustment on baseline value||||||0.1
72497317|NCT00542620|144524492|SUPERIORITY_OR_OTHER|||||||0.166|||||||ANCOVA|With adjustment on baseline value||||||0.166
72497318|NCT00542620|144524493|SUPERIORITY_OR_OTHER|||||||0.023|||||||ANCOVA|With adjustment on baseline value||||||0.023
72497319|NCT00542620|144524494|SUPERIORITY_OR_OTHER|||||||0.439|||||||ANCOVA|With adjustment on baseline value||||||0.439
72497320|NCT00542620|144524495|SUPERIORITY_OR_OTHER|||||||0.202|||||||ANCOVA|With adjustment on baseline value||||||0.202
72497321|NCT00542620|144524496|SUPERIORITY_OR_OTHER|||||||0.665|||||||ANCOVA|With adjustment on baseline value||||||0.665
72497322|NCT00956930|144524503|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.122||||0.007|TWO_SIDED|95.0|0.027|0.557|||Log Rank|||||0.557|0.027|0.007
72497323|NCT02908100|144524515|SUPERIORITY||Absolute Difference|6.4||||0.373|TWO_SIDED|95.0|-8.5|21.2|||Cochran-Mantel-Haenszel|||||21.2|-8.5|0.373
72497324|NCT02908100|144524515|SUPERIORITY||Absolute Difference|7.5||||0.339|TWO_SIDED|95.0|-7.3|22.4|||Cochran-Mantel-Haenszel|||||22.4|-7.3|0.339
72497325|NCT02908100|144524516|SUPERIORITY||Absolute Difference|8.7||||0.223|TWO_SIDED|95.0|-6.1|23.5|||Cochran-Mantel-Haenszel|||||23.5|-6.1|0.223
72560491|NCT00762411|144651345|SUPERIORITY_OR_OTHER|||||||0.56||95.0|||||Mixed Models Analysis|||||||0.560
72560492|NCT00762411|144651346|SUPERIORITY_OR_OTHER|||||||0.959||95.0|||||Mixed Models Analysis|||||||0.959
72560493|NCT00762411|144651347|SUPERIORITY_OR_OTHER|||||||0.567||95.0|||||Mixed Models Analysis|||||||0.567
72560494|NCT00762411|144651348|SUPERIORITY_OR_OTHER|||||||0.199||95.0|||||Mixed Models Analysis|||||||0.199
72560495|NCT00762411|144651349|SUPERIORITY_OR_OTHER|||||||0.294||95.0|||||Mixed Models Analysis|||||||0.294
72560496|NCT00762411|144651350|SUPERIORITY_OR_OTHER|||||||0.477||95.0|||||Mixed Models Analysis|||||||0.477
72560497|NCT00762411|144651351|SUPERIORITY_OR_OTHER|||||||0.673||95.0|||||ANCOVA|||||||0.673
72560498|NCT00762411|144651352|SUPERIORITY_OR_OTHER|||||||0.622||95.0|||||Mixed Models Analysis|||||||0.622
72560499|NCT00762411|144651353|SUPERIORITY_OR_OTHER|||||||0.178||95.0|||||Mixed Models Analysis|||||||0.178
72560500|NCT00762411|144651354|SUPERIORITY_OR_OTHER|||||||0.632||95.0|||||Mixed Models Analysis|||||||0.632
72444776|NCT03854578|144404153|OTHER|ANOVA model with treatment (BI 1358894 versus placebo) and severity of depression (MADRS ≥20 versus \<20) as fixed effects. The Citalopram treatment arm was used as a positive control group. It was not planned to compare pharmacodynamic effects between Citalopram and BI 1358894.|Mean change|-0.03|STANDARD_ERROR_OF_MEAN|0.03||0.3495|TWO_SIDED|90.0|-0.08|0.02|||ANOVA||Mean change calculated as: BI - Placebo.|Mean BOLD signal % change/ Anterior Cingulate Cortex Left||0.02|-0.08|0.3495
72444777|NCT03854578|144404153|OTHER|ANOVA model with treatment (BI 1358894 versus placebo) and severity of depression (MADRS ≥20 versus \<20) as fixed effects. The Citalopram treatment arm was used as a positive control group. It was not planned to compare pharmacodynamic effects between Citalopram and BI 1358894.|Mean change|-0.01|STANDARD_ERROR_OF_MEAN|0.03||0.7008|TWO_SIDED|90.0|-0.07|0.04|||ANOVA||Mean change calculated as: BI - Placebo.|Mean BOLD signal % change/ Anterior Cingulate Cortex right||0.04|-0.07|0.7008
72444778|NCT03854578|144404153|OTHER|ANOVA model with treatment (BI 1358894 versus placebo) and severity of depression (MADRS ≥20 versus \<20) as fixed effects. The Citalopram treatment arm was used as a positive control group. It was not planned to compare pharmacodynamic effects between Citalopram and BI 1358894.|Mean change|-0.02|STANDARD_ERROR_OF_MEAN|0.04||0.6635|TWO_SIDED|90.0|-0.08|0.05|||ANOVA||Mean change calculated as: BI - Placebo.|Mean BOLD signal % change/ Dorsolateral Prefrontal Cortex Left||0.05|-0.08|0.6635
72444779|NCT03854578|144404153|OTHER|ANOVA model with treatment (BI 1358894 versus placebo) and severity of depression (MADRS ≥20 versus \<20) as fixed effects. The Citalopram treatment arm was used as a positive control group. It was not planned to compare pharmacodynamic effects between Citalopram and BI 1358894.|Mean change|-0.01|STANDARD_ERROR_OF_MEAN|0.05||0.8792|TWO_SIDED|90.0|-0.09|0.07|||ANOVA||Mean change calculated as: BI - Placebo.|Mean BOLD signal % change/ Dorsolateral Prefrontal Cortex Right||0.07|-0.09|0.8792
72444780|NCT03854578|144404153|OTHER|ANOVA model with treatment (BI 1358894 versus placebo) and severity of depression (MADRS ≥20 versus \<20) as fixed effects. The Citalopram treatment arm was used as a positive control group. It was not planned to compare pharmacodynamic effects between Citalopram and BI 1358894.|Mean change|-0.08|STANDARD_ERROR_OF_MEAN|0.04||0.0419|TWO_SIDED|90.0|-0.15|-0.02|||ANOVA||Mean change calculated as: BI - Placebo.|Mean BOLD signal % change/ Insula Left||-0.02|-0.15|0.0419
72444781|NCT03854578|144404153|OTHER|ANOVA model with treatment (BI 1358894 versus placebo) and severity of depression (MADRS ≥20 versus \<20) as fixed effects. The Citalopram treatment arm was used as a positive control group. It was not planned to compare pharmacodynamic effects between Citalopram and BI 1358894.|Mean change|-0.05|STANDARD_ERROR_OF_MEAN|0.04||0.1658|TWO_SIDED|90.0|-0.12|0.01|||ANOVA||Mean change calculated as: BI - Placebo.|Mean BOLD signal % change/ Insula Right||0.01|-0.12|0.1658
72444782|NCT03854578|144404153|OTHER|ANOVA model with treatment (Citalopram versus placebo) and severity of depression (MADRS ≥20 versus \<20) as fixed effects. The Citalopram treatment arm was used as a positive control group. It was not planned to compare pharmacodynamic effects between Citalopram and BI 1358894.|Mean change|-0.02|STANDARD_ERROR_OF_MEAN|0.04||0.6673|TWO_SIDED|90.0|-0.08|0.05|||ANOVA||Mean change calculated as: BI - Placebo.|Mean BOLD Signal % change/ Amygdala Left||0.05|-0.08|0.6673
72444783|NCT03854578|144404153|OTHER|ANOVA model with treatment (Citalopram versus placebo) and severity of depression (MADRS ≥20 versus \<20) as fixed effects. The Citalopram treatment arm was used as a positive control group. It was not planned to compare pharmacodynamic effects between Citalopram and BI 1358894.|Mean change|-0.07|STANDARD_ERROR_OF_MEAN|0.04||0.0778|TWO_SIDED|90.0|-0.14|-0.01|||ANOVA||Mean change calculated as: BI - Placebo.|Mean BOLD Signal % Change/ Amygdala Right||-0.01|-0.14|0.0778
72444784|NCT03854578|144404153|OTHER|ANOVA model with treatment (BI 1358894 versus placebo) and severity of depression (MADRS ≥20 versus \<20) as fixed effects. The Citalopram treatment arm was used as a positive control group. It was not planned to compare pharmacodynamic effects between Citalopram and BI 1358894.|Mean change|-0.03|STANDARD_ERROR_OF_MEAN|0.03||0.3258|TWO_SIDED|90.0|-0.08|0.02|||ANOVA||Mean change calculated as: BI - Placebo.|Mean BOLD signal % change/ Anterior Cingulate Cortex Left||0.02|-0.08|0.3258
72444785|NCT03854578|144404153|OTHER|ANOVA model with treatment (Citalopram versus placebo) and severity of depression (MADRS ≥20 versus \<20) as fixed effects. The Citalopram treatment arm was used as a positive control group. It was not planned to compare pharmacodynamic effects between Citalopram and BI 1358894.|Mean change|-0.02|STANDARD_ERROR_OF_MEAN|0.03||0.5954|TWO_SIDED|90.0|-0.07|0.04|||ANOVA||Mean change calculated as: BI - Placebo.|Mean BOLD signal % change/ Anterior Cingulate Cortex Right||0.04|-0.07|0.5954
72444786|NCT03854578|144404153|OTHER|ANOVA model with treatment (Citalopram versus placebo) and severity of depression (MADRS ≥20 versus \<20) as fixed effects. The Citalopram treatment arm was used as a positive control group. It was not planned to compare pharmacodynamic effects between Citalopram and BI 1358894.|Mean change|-0.02|STANDARD_ERROR_OF_MEAN|0.04||0.5911|TWO_SIDED|90.0|-0.08|0.04|||ANOVA||Mean change calculated as: BI - Placebo.|Mean BOLD signal % change/ Dorsolateral Prefrontal Cortex Left||0.04|-0.08|0.5911
72444787|NCT03854578|144404153|OTHER|ANOVA model with treatment (Citalopram versus placebo) and severity of depression (MADRS ≥20 versus \<20) as fixed effects. The Citalopram treatment arm was used as a positive control group. It was not planned to compare pharmacodynamic effects between Citalopram and BI 1358894.|Mean change|-0.01|STANDARD_ERROR_OF_MEAN|0.06||0.8283|TWO_SIDED|90.0|-0.11|0.08|||ANOVA||Mean change calculated as: BI - Placebo.|Mean BOLD signal % change/ Dorsolateral Prefrontal Cortex Right||0.08|-0.11|0.8283
72444788|NCT03854578|144404153|OTHER|ANOVA model with treatment (Citalopram versus placebo) and severity of depression (MADRS ≥20 versus \<20) as fixed effects. The Citalopram treatment arm was used as a positive control group. It was not planned to compare pharmacodynamic effects between Citalopram and BI 1358894.|Mean change|-0.05|STANDARD_ERROR_OF_MEAN|0.04||0.1797|TWO_SIDED|90.0|-0.12|0.01|||ANOVA||Mean change calculated as: BI - Placebo.|Mean BOLD signal % change/ Insula Left||0.01|-0.12|0.1797
72444789|NCT03854578|144404153|OTHER|ANOVA model with treatment (Citalopram versus placebo) and severity of depression (MADRS ≥20 versus \<20) as fixed effects. The Citalopram treatment arm was used as a positive control group. It was not planned to compare pharmacodynamic effects between Citalopram and BI 1358894.|Mean change|-0.02|STANDARD_ERROR_OF_MEAN|0.04||0.5772|TWO_SIDED|90.0|-0.08|0.04|||ANOVA||Mean change calculated as: BI - Placebo.|Mean BOLD signal % change/ Insula Right||0.04|-0.08|0.5772
72497326|NCT02908100|144524516|SUPERIORITY||Absolute Difference|3.0||||0.737|TWO_SIDED|95.0|-11.8|17.7|||Cochran-Mantel-Haenszel|||||17.7|-11.8|0.737
72497327|NCT02908100|144524517|SUPERIORITY||Absolute Difference|4.1||||0.614|TWO_SIDED|95.0|-10.7|18.9|||Cochran-Mantel-Haenszel|||||18.9|-10.7|0.614
72560501|NCT00762411|144651355|SUPERIORITY_OR_OTHER|||||||0.009||95.0|||||ANCOVA|||||||0.009
72560502|NCT00762411|144651356|SUPERIORITY_OR_OTHER|||||||0.426||95.0|||||ANCOVA|||||||0.426
72560503|NCT00762411|144651357|SUPERIORITY_OR_OTHER|||||||0.101||95.0||||This is the p-value for the Right Hippocampal Volume.|ANCOVA|||||||0.101
72560504|NCT00762411|144651357|SUPERIORITY_OR_OTHER|||||||0.772||95.0||||This is the p-value for the Left Hippocampal Volume.|ANCOVA|||||||0.772
72619229|NCT01655069|144769070|OTHER||Adjusted change from baseline|-2.2|STANDARD_ERROR_OF_MEAN|0.65|||TWO_SIDED|95.0|-3.48|-0.93|||Repeated Measures ANCOVA|Duration of solifenacin treatment: 52 weeks||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant."||-0.93|-3.48|
72389222|NCT02499783|144286547|SUPERIORITY||Adjusted Risk Difference|40.4|||<|0.001|TWO_SIDED|95.0|26.7|54.2||Based on Cochran-Mantel-Haenszel test stratified by be stratified by Crohn's disease severity (CDAI \<= 300, \> 300) at Baseline and corticosteroid use at Baseline.|Cochran-Mantel-Haenszel||Risk difference = (adalimumab 160/80 mg - placebo). Based on Cochran-Mantel-Haenszel test stratified by be stratified by Crohn's disease severity (CDAI \<= 300, \> 300) at Baseline and corticosteroid use at Baseline.|||54.2|26.7|< 0.001
72389223|NCT02499783|144286548|SUPERIORITY||Adjusted Risk Difference|50.2|||<|0.001|TWO_SIDED|95.0|36.9|63.5||Based on Cochran-Mantel-Haenszel test stratified by be stratified by Crohn's disease severity (CDAI \<= 300, \> 300) at Baseline and corticosteroid use at Baseline.|Cochran-Mantel-Haenszel||Risk difference = (adalimumab 160/80 mg - placebo). Based on Cochran-Mantel-Haenszel test stratified by be stratified by Crohn's disease severity (CDAI \<= 300, \> 300) at Baseline and corticosteroid use at Baseline.|||63.5|36.9|< 0.001
72389224|NCT02499783|144286549|SUPERIORITY||Adjusted Risk Difference|27.6|||<|0.001|TWO_SIDED|95.0|18.2|37.0||Based on Cochran-Mantel-Haenszel test stratified by be stratified by Crohn's disease severity (CDAI \<= 300, \> 300) at Baseline and corticosteroid use at Baseline.|Cochran-Mantel-Haenszel||Risk difference = (adalimumab 160/80 mg - placebo). Based on Cochran-Mantel-Haenszel test stratified by be stratified by Crohn's disease severity (CDAI \<= 300, \> 300) at Baseline and corticosteroid use at Baseline.|||37.0|18.2|< 0.001
72389225|NCT02499783|144286551|SUPERIORITY||Adjusted Risk Difference|19.6||||0.002|TWO_SIDED|95.0|7.1|32.1||Based on Cochran-Mantel-Haenszel test stratified by be stratified by Crohn's disease severity (CDAI \<= 300, \> 300) at Baseline and corticosteroid use at Baseline.|Cochran-Mantel-Haenszel||Risk difference = (adalimumab 160/80 mg - placebo). Based on Cochran-Mantel-Haenszel test stratified by be stratified by Crohn's disease severity (CDAI \<= 300, \> 300) at Baseline and corticosteroid use at Baseline.|||32.1|7.1|0.002
72389226|NCT02499783|144286553|SUPERIORITY||Least Squares Mean Difference|-385.2|||<|0.001|TWO_SIDED|95.0|-598.81|-171.5||P-value for test of difference between adalimumab and placebo for mean change from Baseline using ANCOVA with Treatment, Crohn's disease severity (CDAI \<= 300, \> 300) at Baseline and corticosteroid use at Baseline, and Baseline value as covariate.|ANCOVA|||||-171.50|-598.81|< 0.001
72389227|NCT02499783|144286554|SUPERIORITY||Adjusted Risk Difference|9.8||||0.001|TWO_SIDED|95.0|3.9|15.8||Based on Cochran-Mantel-Haenszel test stratified by be stratified by Crohn's disease severity (CDAI \<= 300, \> 300) at Baseline and corticosteroid use at Baseline.|Cochran-Mantel-Haenszel||Risk difference = (adalimumab 160/80 mg - placebo). Based on Cochran-Mantel-Haenszel test stratified by be stratified by Crohn's disease severity (CDAI \<= 300, \> 300) at Baseline and corticosteroid use at Baseline.|||15.8|3.9|0.001
72389228|NCT02499783|144286556|SUPERIORITY||Adjusted Risk Difference|18.4|||<|0.001|TWO_SIDED|95.0|8.2|28.6||Based on Cochran-Mantel-Haenszel test stratified by Crohn's disease severity (CDAI \<= 300 and CDAI \>300) at baseline and corticosteroid use at baseline.|Cochran-Mantel-Haenszel||Risk difference = (adalimumab 160/80 mg - placebo). Based on Cochran-Mantel-Haenszel test stratified by Crohn's disease severity (CDAI \<= 300 and CDAI \>300) at baseline and corticosteroid use at baseline.|Clinical Remission at Week 2||28.6|8.2|< 0.001
72389229|NCT02499783|144286556|SUPERIORITY||Adjusted Risk Difference|30.4|||<|0.001|TWO_SIDED|95.0|19.2|41.7||Based on Cochran-Mantel-Haenszel test stratified by Crohn's disease severity (CDAI \<= 300 and CDAI \>300) at baseline and corticosteroid use at baseline.|Cochran-Mantel-Haenszel||Risk difference = (adalimumab 160/80 mg - placebo). Based on Cochran-Mantel-Haenszel test stratified by Crohn's disease severity (CDAI \<= 300 and CDAI \>300) at baseline and corticosteroid use at baseline.|Clinical Remission at Week 4||41.7|19.2|< 0.001
72389230|NCT02499783|144286558|SUPERIORITY||Adjusted Risk Difference|21.4|||<|0.001|TWO_SIDED|95.0|12.6|30.2||Based on Cochran-Mantel-Haenszel test stratified by Crohn's disease severity (CDAI \<= 300 and CDAI \>300) at baseline and corticosteroid use at baseline.|Cochran-Mantel-Haenszel||Risk difference = (adalimumab 160/80 mg - placebo). Based on Cochran-Mantel-Haenszel test stratified by Crohn's disease severity (CDAI \<= 300 and CDAI \>300) at baseline and corticosteroid use at baseline.|Clinical Remission (CDAI \< 150) Plus A Reduction in HS-CRP of at Least 50% From Baseline at Week 2||30.2|12.6|< 0.001
72469490|NCT03670277|144462713|OTHER|Statistically significance of difference. Statistical difference would be concluded if the lower limit was greater than 0 or the upper limit was less than 0.|Least Square Mean Difference|1.414|STANDARD_ERROR_OF_MEAN|0.603|||TWO_SIDED|95.0|0.228|2.599|||Mixed Models Analysis|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.|Mean Difference was calculated as Test - Control|At +30°||2.599|0.228|
72560505|NCT00762411|144651358|SUPERIORITY_OR_OTHER|||||||0.326||95.0|||||ANCOVA|||||||0.326
72560506|NCT00762411|144651359|SUPERIORITY_OR_OTHER|||||||0.117||95.0|||||ANCOVA|||||||0.117
72560507|NCT00762411|144651368|SUPERIORITY_OR_OTHER|||||||0.929||95.0|||||Mixed Models Analysis|||||||0.929
72560508|NCT00762411|144651369|SUPERIORITY_OR_OTHER|||||||0.437||95.0|||||Mixed Models Analysis|||||||0.437
72560509|NCT00762411|144651370|SUPERIORITY_OR_OTHER|||||||0.318||95.0|||||ANCOVA|||||||0.318
72560510|NCT00762411|144651371|SUPERIORITY_OR_OTHER|||||||0.417||95.0|||||ANCOVA|||||||0.417
72560511|NCT00762411|144651372|SUPERIORITY_OR_OTHER|||||||0.805||95.0|||||Mixed Models Analysis|||||||0.805
72560512|NCT00762411|144651373|SUPERIORITY_OR_OTHER|||||||0.893||95.0|||||Mixed Models Analysis|||||||0.893
72560513|NCT01023061|144651374|SUPERIORITY||Median Difference (Final Values)|0.74|||<|0.01|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||< 0.01
72560514|NCT04556734|144651429|OTHER|F-test|LS Mean Difference|-14.14||||0.2579|TWO_SIDED|95.0|-38.933|10.648|||Mixed Models Analysis|||Mixed model for repeated measurements (MMRM) was used for evaluation. The model included the treatment group, visit and treatment-by-visit interaction as fixed effects, disease duration and baseline SALT I score as covariates.||10.648|-38.933|0.2579
72444790|NCT03854578|144404154|OTHER|ANOVA model with treatment (BI 1358894 versus placebo) and severity of depression (MADRS ≥20 versus \<20) as fixed effects. The Citalopram treatment arm was used as a positive control group. It was not planned to compare pharmacodynamic effects between Citalopram and BI 1358894.|Mean change|-0.09|STANDARD_ERROR_OF_MEAN|0.03||0.0147|TWO_SIDED|90.0|-0.14|-0.03|||ANOVA||Mean change calculated as: BI - Placebo.|Mean BOLD signal % change/ Amygdala Left||-0.03|-0.14|0.0147
72444791|NCT03854578|144404154|OTHER|ANOVA model with treatment (BI 1358894 versus placebo) and severity of depression (MADRS ≥20 versus \<20) as fixed effects. The Citalopram treatment arm was used as a positive control group. It was not planned to compare pharmacodynamic effects between Citalopram and BI 1358894.|Mean change|-0.07|STANDARD_ERROR_OF_MEAN|0.03||0.048|TWO_SIDED|90.0|-0.13|-0.01|||ANOVA||Mean change calculated as: BI - Placebo.|Mean BOLD signal % change/ Amygdala Right||-0.01|-0.13|0.0480
72444792|NCT03854578|144404154|OTHER|ANOVA model with treatment (BI 1358894 versus placebo) and severity of depression (MADRS ≥20 versus \<20) as fixed effects. The Citalopram treatment arm was used as a positive control group. It was not planned to compare pharmacodynamic effects between Citalopram and BI 1358894.|Mean change|-0.07|STANDARD_ERROR_OF_MEAN|0.03||0.0294|TWO_SIDED|90.0|-0.12|-0.02|||ANOVA||Mean change calculated as: BI - Placebo.|Mean BOLD signal % change/ Anterior Cingulate Cortex Left||-0.02|-0.12|0.0294
72444793|NCT03854578|144404154|OTHER|ANOVA model with treatment (BI 1358894 versus placebo) and severity of depression (MADRS ≥20 versus \<20) as fixed effects. The Citalopram treatment arm was used as a positive control group. It was not planned to compare pharmacodynamic effects between Citalopram and BI 1358894.|Mean change|-0.07|STANDARD_ERROR_OF_MEAN|0.03||0.0359|TWO_SIDED|90.0|-0.13|-0.02|||ANOVA||Mean change calculated as: BI - Placebo.|Mean BOLD signal % change/ Anterior Cingulate Cortex Right||-0.02|-0.13|0.0359
72444794|NCT03854578|144404154|OTHER|ANOVA model with treatment (BI 1358894 versus placebo) and severity of depression (MADRS ≥20 versus \<20) as fixed effects. The Citalopram treatment arm was used as a positive control group. It was not planned to compare pharmacodynamic effects between Citalopram and BI 1358894.|Mean change|-0.13|STANDARD_ERROR_OF_MEAN|0.04||0.0022|TWO_SIDED|90.0|-0.19|-0.06|||ANOVA||Mean change calculated as: BI - Placebo.|Mean BOLD signal % change/ Dorsolateral Prefrontal Cortex Left||-0.06|-0.19|0.0022
72497328|NCT02908100|144524517|SUPERIORITY||Absolute Difference|4.1||||0.607|TWO_SIDED|95.0|-10.7|18.9|||Cochran-Mantel-Haenszel|||||18.9|-10.7|0.607
72497329|NCT02908100|144524518|SUPERIORITY||Absolute Difference|6.4||||0.41|TWO_SIDED|95.0|-8.5|21.2|||Cochran-Mantel-Haenszel|||||21.2|-8.5|0.410
72560515|NCT04556734|144651429|OTHER|F-test|LS Mean Difference|-21.79||||0.0592|TWO_SIDED|95.0|-44.446|0.871|||Mixed Models Analysis|||MMRM was used for evaluation. The model included the treatment group, visit and treatment-by-visit interaction as fixed effects, disease duration and baseline SALT I score as covariates.||0.871|-44.446|0.0592
72560516|NCT04556734|144651430|OTHER|F-test|Least square (LS) Mean Difference|-9.23||||0.1283|TWO_SIDED|95.0|-21.217|2.748|||Mixed Models Analysis|||MMRM was used for evaluation. The model included the treatment group, visit and treatment-by-visit interaction as fixed effects, disease duration and baseline SALT I score as covariates.||2.748|-21.217|0.1283
72560517|NCT04556734|144651430|OTHER|F-test|LS Mean Difference|-8.99||||0.1057|TWO_SIDED|95.0|-19.936|1.962|||Mixed Models Analysis|||MMRM was used for evaluation. The model included the treatment group, visit and treatment-by-visit interaction as fixed effects, disease duration and baseline SALT I score as covariates.||1.962|-19.936|0.1057
72560518|NCT04556734|144651431|OTHER||Response rate difference|11.5||||0.4067|TWO_SIDED|95.0|-14.22|37.31||P-values were based on the comparison of etrasimod versus placebo.|Cochran-Mantel-Haenszel||Clopper-Pearson method|\>= 30% Improvement: Response rate difference was difference in response rates between DB Treatment period: Etrasimod 2 mg and DB Treatment period: Placebo||37.31|-14.22|0.4067
72444795|NCT03854578|144404154|OTHER|ANOVA model with treatment (BI 1358894 versus placebo) and severity of depression (MADRS ≥20 versus \<20) as fixed effects. The Citalopram treatment arm was used as a positive control group. It was not planned to compare pharmacodynamic effects between Citalopram and BI 1358894.|Mean change|-0.08|STANDARD_ERROR_OF_MEAN|0.05||0.104|TWO_SIDED|90.0|-0.15|0.0|||ANOVA||Mean change calculated as: BI - Placebo.|Mean BOLD signal % change/ Dorsolateral Prefrontal Cortex Right||0.00|-0.15|0.1040
72619230|NCT06399471|144769072|OTHER|One-way Repeated Measures ANOVA with sphericity correction (Huynh-Feldt) applied if necessary.||||||0.126||||||One-way Repeated Measures ANOVA with sphericity correction (Huynh-Feldt) applied if necessary.|ANOVA|||An ANOVA was used to compare the Power Knee and the C-Leg 4.0 when used during Ten Meter Walking Test.||||0.126
72444796|NCT03854578|144404154|OTHER|ANOVA model with treatment (BI 1358894 versus placebo) and severity of depression (MADRS ≥20 versus \<20) as fixed effects. The Citalopram treatment arm was used as a positive control group. It was not planned to compare pharmacodynamic effects between Citalopram and BI 1358894.|Mean change|-0.12|STANDARD_ERROR_OF_MEAN|0.04||0.0022|TWO_SIDED|90.0|-0.18|-0.06|||ANOVA||Mean change calculated as: BI - Placebo.|Mean BOLD signal % change/ Insula Left||-0.06|-0.18|0.0022
72469491|NCT02660112|144462714|SUPERIORITY|||||||0.336|||||||Wilcoxon (Mann-Whitney)|||||||0.336
72469492|NCT01515943|144462716|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-4.0||||0.56|TWO_SIDED|97.5|-19.0|11.0||Linear contrasts performed with a type I error rate of 2.5% based on a Bonferroni adjustment (overall type I error rate of 5% for 2 pairwise treatment group comparisons).|Biniomial regression|Adjusted for baseline covariates of CISS score, mean NPC break and mean PFV blur. Linear contrasts performed with Bonferroni adjustment (alpha=0.025)|Negative values for the treatment group difference favor the HB-PU group. Results of the treatment group comparison are adjusted for baseline covariates of CISS, mean NPC break and mean PFV blur.|The primary outcome was success at 12 weeks. The sample size was computed to have 90% power to detect a treatment group difference between the HB-C versus HB-PU groups, assuming true population success percentages of 30% and 15% for the HB-C and HB-PU groups, respectively, with a type I error rate of 2.5%. The treatment group comparison was adjusted for baseline covariates of CISS score (\<28 points vs ≥28 points), mean NPC break (\<10 cm vs ≥10 cm) and mean PFV blur (≥15 pd vs \<15 pd).||11|-19|0.56
72497330|NCT02908100|144524518|SUPERIORITY||Absolute Difference|6.4||||0.418|TWO_SIDED|95.0|-8.5|21.2|||Cochran-Mantel-Haenszel|||||21.2|-8.5|0.418
72444797|NCT03854578|144404154|OTHER|ANOVA model with treatment (BI 1358894 versus placebo) and severity of depression (MADRS ≥20 versus \<20) as fixed effects. The Citalopram treatment arm was used as a positive control group. It was not planned to compare pharmacodynamic effects between Citalopram and BI 1358894.|Mean change|-0.08|STANDARD_ERROR_OF_MEAN|0.04||0.0331|TWO_SIDED|90.0|-0.14|-0.02|||ANOVA||Mean change calculated as: BI - Placebo.|Mean BOLD signal % change/ Insula Right||-0.02|-0.14|0.0331
72444798|NCT03854578|144404154|OTHER|ANOVA model with treatment (Citalopram versus placebo) and severity of depression (MADRS ≥20 versus \<20) as fixed effects. The Citalopram treatment arm was used as a positive control group. It was not planned to compare pharmacodynamic effects between Citalopram and BI 1358894.|Mean change|-0.05|STANDARD_ERROR_OF_MEAN|0.04||0.2149|TWO_SIDED|90.0|-0.11|0.02|||ANOVA||Mean change calculated as: BI - Placebo.|Mean BOLD signal % change/ Amygdala Left||0.02|-0.11|0.2149
72444799|NCT03854578|144404154|OTHER|ANOVA model with treatment (Citalopram versus placebo) and severity of depression (MADRS ≥20 versus \<20) as fixed effects. The Citalopram treatment arm was used as a positive control group. It was not planned to compare pharmacodynamic effects between Citalopram and BI 1358894.|Mean change|-0.02|STANDARD_ERROR_OF_MEAN|0.04||0.6896|TWO_SIDED|90.0|-0.08|0.05|||ANOVA||Mean change calculated as: BI - Placebo.|Mean BOLD signal % change/ Amygdala Right||0.05|-0.08|0.6896
72444800|NCT03854578|144404154|OTHER|ANOVA model with treatment (Citalopram versus placebo) and severity of depression (MADRS ≥20 versus \<20) as fixed effects. The Citalopram treatment arm was used as a positive control group. It was not planned to compare pharmacodynamic effects between Citalopram and BI 1358894.|Mean change|-0.02|STANDARD_ERROR_OF_MEAN|0.03||0.4769|TWO_SIDED|90.0|-0.06|0.02|||ANOVA||Mean change calculated as: BI - Placebo.|Mean BOLD signal % change/ Anterior Cingulate Cortex Left||0.02|-0.06|0.4769
72444801|NCT03854578|144404154|OTHER|ANOVA model with treatment (Citalopram versus placebo) and severity of depression (MADRS ≥20 versus \<20) as fixed effects. The Citalopram treatment arm was used as a positive control group. It was not planned to compare pharmacodynamic effects between Citalopram and BI 1358894.|Mean change|-0.01|STANDARD_ERROR_OF_MEAN|0.03||0.768|TWO_SIDED|90.0|-0.07|0.05|||ANOVA||Mean change calculated as: BI - Placebo.|Mean BOLD signal % change/ Anterior Cingulate Cortex Right||0.05|-0.07|0.7680
72444802|NCT03854578|144404154|OTHER|ANOVA model with treatment (BI 1358894 versus placebo) and severity of depression (MADRS ≥20 versus \<20) as fixed effects. The Citalopram treatment arm was used as a positive control group. It was not planned to compare pharmacodynamic effects between Citalopram and BI 1358894.|Mean change|-0.01|STANDARD_ERROR_OF_MEAN|0.04||0.7997|TWO_SIDED|90.0|-0.08|0.06|||ANOVA||Mean change calculated as: BI - Placebo.|Mean BOLD signal % change/ Dorsolateral Prefrontal Cortex Left||0.06|-0.08|0.7997
72444803|NCT03854578|144404154|OTHER|ANOVA model with treatment (Citalopram versus placebo) and severity of depression (MADRS ≥20 versus \<20) as fixed effects. The Citalopram treatment arm was used as a positive control group. It was not planned to compare pharmacodynamic effects between Citalopram and BI 1358894.|Mean change|-0.01|STANDARD_ERROR_OF_MEAN|0.04||0.8334|TWO_SIDED|90.0|-0.08|0.06|||ANOVA||Mean change calculated as: BI - Placebo.|Mean BOLD signal % change/ Dorsolateral Prefrontal Cortex Right||0.06|-0.08|0.8334
72444804|NCT03854578|144404154|OTHER|ANOVA model with treatment (Citalopram versus placebo) and severity of depression (MADRS ≥20 versus \<20) as fixed effects. The Citalopram treatment arm was used as a positive control group. It was not planned to compare pharmacodynamic effects between Citalopram and BI 1358894.|Mean change|-0.01|STANDARD_ERROR_OF_MEAN|0.04||0.7402|TWO_SIDED|90.0|-0.07|0.05|||ANOVA||Mean change calculated as: BI - Placebo.|Mean BOLD signal % change/ Insula Left||0.05|-0.07|0.7402
72444805|NCT03854578|144404154|OTHER|ANOVA model with treatment (Citalopram versus placebo) and severity of depression (MADRS ≥20 versus \<20) as fixed effects. The Citalopram treatment arm was used as a positive control group. It was not planned to compare pharmacodynamic effects between Citalopram and BI 1358894.|Mean change|0.01|STANDARD_ERROR_OF_MEAN|0.04||0.812|TWO_SIDED|90.0|-0.06|0.08|||ANOVA||Mean change calculated as: BI - Placebo.|Mean BOLD signal % change/ Insula Right||0.08|-0.06|0.8120
72444806|NCT05063994|144404166|NON_INFERIORITY|Non-inferiority of Chronocort to Cortef was declared if the 95% CI for the difference in biochemical response rates between the 2 treatment arms (Chronocort minus Cortef) was wholly above minus 15 percentage points.|Treatment Difference|25.7|STANDARD_ERROR_OF_MEAN|11.82||0.0003|TWO_SIDED|95.0|2.5|48.9||One-sided non-inferiority. The Ge et al (2011) method was used to calculate the estimate, standard error, confidence interval and P-value for the treatment difference from the results of a logistic regression analysis.|Regression, Logistic|||||48.9|2.5|0.0003
72497331|NCT02908100|144524519|SUPERIORITY||Absolute Difference|14.9||||0.378|TWO_SIDED|95.0|-14.0|43.7|||Cochran-Mantel-Haenszel|||Plasmablast Signature Level Q1||43.7|-14|0.378
72497332|NCT02908100|144524519|SUPERIORITY||Absolute Difference|7.5||||0.732|TWO_SIDED|95.0|-21.7|36.7|||Cochran-Mantel-Haenszel|||Plasmablast Signature Level Q1||36.7|-21.7|0.732
72497333|NCT02908100|144524519|SUPERIORITY||Absolute Difference|-0.4||||0.5|TWO_SIDED|95.0|-29.2|28.4|||Cochran-Mantel-Haenszel|||Plasmablast Signature Level Q2||28.4|-29.2|0.500
72497334|NCT02908100|144524519|SUPERIORITY||Absolute Difference|8.6||||0.234|TWO_SIDED|95.0|-21.4|38.7|||Cochran-Mantel-Haenszel|||Plasmablast Signature Level Q2||38.7|-21.4|0.234
72560519|NCT04556734|144651431|OTHER||Response rate difference|17.5||||0.2171|TWO_SIDED|95.0|-8.23|43.19||P-values were based on the comparison of etrasimod versus placebo.|Cochran-Mantel-Haenszel||Clopper-Pearson method|\>= 30% Improvement: Response rate difference was difference in response rates between DB Treatment period: Etrasimod 3 mg and DB Treatment period: Placebo||43.19|-8.23|0.2171
72619231|NCT06399471|144769072|OTHER|One-way Repeated Measures ANOVA with sphericity correction (Huynh-Feldt) applied if necessary.||||||0.015|||||||ANOVA|||An ANOVA was used to compare the Power Knee and the Rheo when used during Ten Meter Walking Test.||||0.015
72497335|NCT02908100|144524519|SUPERIORITY||Absolute Difference|15.5||||0.364|TWO_SIDED|95.0|-14.9|46.0|||Cochran-Mantel-Haenszel|||Plasmablast Signature Level Q3||46|-14.9|0.364
72497336|NCT02908100|144524519|SUPERIORITY||Absolute Difference|15.2||||0.134|TWO_SIDED|95.0|-14.1|44.4|||Cochran-Mantel-Haenszel|||Plasmablast Signature Level Q3||44.4|-14.1|0.134
72497337|NCT02908100|144524519|SUPERIORITY||Absolute Difference|-7.1||||0.83|TWO_SIDED|95.0|-37.6|23.3|||Cochran-Mantel-Haenszel|||Plasmablast Signature Level Q4||23.3|-37.6|0.830
72497338|NCT02908100|144524519|SUPERIORITY||Absolute Difference|-2.2||||0.963|TWO_SIDED|95.0|-32.1|27.8|||Cochran-Mantel-Haenszel|||Plasmablast Signature Level Q4||27.8|-32.1|0.963
72619232|NCT06399471|144769072|OTHER|One-way Repeated Measures ANOVA with sphericity correction (Huynh-Feldt) applied if necessary.||||||0.852|||||||ANOVA|||An ANOVA was used to compare the Rheo and the C-Leg 4.0 when used during Ten Meter Walking Test.||||0.852
72619233|NCT06399471|144769073|OTHER|One-way Repeated Measures ANOVA with sphericity correction (Huynh-Feldt) applied if necessary||||||0.003|||||||ANOVA|||An ANOVA was used to compare the Power Knee and the C-Leg 4.0 when used during Two Meter Walking Test.||||0.003
72619234|NCT06399471|144769073|OTHER|One-way Repeated Measures ANOVA with sphericity correction (Huynh-Feldt) applied if necessary||||||0.027|||||||ANOVA|||An ANOVA was used to compare the Power Knee and the Rheo when used during Two Meter Walking Test.||||0.027
72619235|NCT06399471|144769073|OTHER|One-way Repeated Measures ANOVA with sphericity correction (Huynh-Feldt) applied if necessary||||||0.425|||||||ANOVA|||An ANOVA was used to compare the Rheo and the C-Leg 4.0 when used during Two Meter Walking Test.||||0.425
72444807|NCT05063994|144404167|SUPERIORITY|Superiority of Chronocort to Cortef with respect to the dose response after 28 weeks of randomized treatment was declared if the two-sided 95% CI for the difference in response rates between the 2 treatment arms (Chronocort minus Cortef) was wholly above zero, provided that non-inferiority of Chronocort to Cortef with respect to the biochemical response had been declared under the primary efficacy objective.|Treatment Difference|25.3|STANDARD_ERROR_OF_MEAN|11.24||0.012|TWO_SIDED|95.0|3.3|47.3||One-sided superiority. The Ge et al (2011) method was used to calculate the estimate, standard error, confidence interval and P-value for the treatment difference from the results of a logistic regression analysis.|Regression, Logistic|||||47.3|3.3|0.012
72444808|NCT05063994|144404168|SUPERIORITY|Superiority of Chronocort to Cortef (with respect to the total daily dose after 28 weeks of randomized treatment) was declared if the two-sided 95% CI for the difference in means between the 2 treatment arms (Chronocort minus Cortef) was wholly below zero, provided that non-inferiority of Chronocort to Cortef in terms of biochemical response had been declared under the primary efficacy objective, and superiority of Chronocort to Cortef in terms of dose response has been declared.|Treatment Difference|-5.8|STANDARD_ERROR_OF_MEAN|1.66||0.0005|TWO_SIDED|95.0|-9.2|-2.5||One-sided superiority.|MMRM|||||-2.5|-9.2|0.0005
72444809|NCT01180634|144404185|SUPERIORITY||Hazard Ratio (HR)|1.33||||0.0715|TWO_SIDED|95.0|0.96|1.84||P-value is determined using a log-rank test stratified by region (US, non-US), age (12-18 years, \>18 years), and baseline FEV1 (\<55%, \>=55%).|Log Rank||Hazard ratio is obtained from a Cox proportional hazards regression model adjusting for region (US, non-US), age (12-18 years, \>18 years), and baseline FEV1 (\<55%, \>=55%).|||1.84|0.96|0.0715
72444810|NCT01180634|144404186|SUPERIORITY||LSMean difference|1.41||||0.0213|TWO_SIDED|95.0|0.21|2.6|||Repeared Measures Model||Estimates are determined from a repeated measures model with terms for treatment, visit, treatment\*visit, region (US, non-US), age (12-18 years, \>18 years), and baseline FEV1 (\<55%, \>=55%).|||2.60|0.21|0.0213
72444811|NCT01180634|144404187|SUPERIORITY||LSMean difference|-0.63||||0.0002|TWO_SIDED|95.0|-0.95|-0.3|||Repeated Measures Model||Estimates are determined from a repeated measures model with terms for treatment, visit, treatment\*visit, region (US, non-US), age (12-18 years, \>18 years), baseline FEV1 (\<55%, \>=55%), and baseline organism log density.|||-0.30|-0.95|0.0002
72444812|NCT01180634|144404188|SUPERIORITY||LSMean difference|0.28||||0.8335|TWO_SIDED|95.0|-2.3|2.85|||Repeated Measures Model||Estimates were determined from a repeated measures model with terms for treatment, visit, treatment\*visit, region (US, non-US), age (12 to 18 years, \> 18 years), Baseline FEV1 (\<55%, ≥ 55%), and Baseline value.|||2.85|-2.30|0.8335
72444813|NCT01180634|144404189|SUPERIORITY||LSMean difference|2.42||||0.0122|TWO_SIDED|95.0|0.53|4.31|||Repeated Measures Model|||||4.31|0.53|0.0122
72619236|NCT06399471|144769074|OTHER|Non-parametric Friedman's test with multiple comparison correction||||||0.006|||||||Non-parametric Friedman's test with mult|||The Non-parametric Friedman's test was used to compare the survey results between the participants using the Power Knee and the C-Leg 4.0.||||0.006
72444814|NCT01180634|144404190|SUPERIORITY||Cox Proportional Hazard|0.82||||0.3|TWO_SIDED|95.0|0.6|1.12||P-value is determined using a log-rank test stratified by region (US, non-US), age (12-18 years, \>18 years), and baseline FEV1 (\<55%, \>=55%).|Log Rank||Hazard ratio is obtained from a Cox proportional hazards regression model adjusting for region (US, non-US), age (12-18 years, \>18 years), and baseline FEV1 (\<55%, \>=55%).|||1.12|0.60|0.3000
72444815|NCT01180634|144404191|SUPERIORITY||Hazard Ratio (HR)|0.98||||0.867|TWO_SIDED|95.0|0.47|2.04||P-value is determined using a log-rank test stratified by region (US, non-US), age (12-18 years, \>18 years), and baseline FEV1 (\<55%, \>=55%).|Log Rank||Hazard ratio is obtained from a Cox proportional hazards regression model adjusting for region (US, non-US), age (12-18 years, \>18 years), and baseline FEV1 (\<55%, \>=55%).|||2.04|0.47|0.8670
72444816|NCT04419168|144404200|SUPERIORITY||Mean Difference (Final Values)|0.54||||0.57|TWO_SIDED|95.0|-1.3|2.37|||Mixed Models Analysis|||||2.37|-1.30|.57
72444817|NCT04419168|144404201|SUPERIORITY||Mean Difference (Final Values)|0.07||||0.79|TWO_SIDED|95.0|-0.46|0.61|||Mixed Models Analysis|||||0.61|-0.46|0.79
72444818|NCT04419168|144404202|SUPERIORITY||Mean Difference (Final Values)|-0.21||||0.75|TWO_SIDED|95.0|-1.55|1.12|||Mixed Models Analysis|||||1.12|-1.55|0.75
72497339|NCT02908100|144524520|SUPERIORITY||Absolute Difference|19.0||||0.189|TWO_SIDED|95.0|-9.4|47.5|||Cochran-Mantel-Haenszel|||Plasmablast Signature Level Q1||47.5|-9.4|0.189
72444819|NCT04419168|144404203|SUPERIORITY||Mean Difference (Final Values)|0.64||||0.31|TWO_SIDED|95.0|-0.6|1.87|||Mixed Models Analysis|||||1.87|-0.60|0.31
72497340|NCT02908100|144524520|SUPERIORITY||Absolute Difference|6.7||||0.909|TWO_SIDED|95.0|-21.9|35.2|||Cochran-Mantel-Haenszel|||Plasmablast Signature Level Q1||35.2|-21.9|0.909
72497341|NCT02908100|144524520|SUPERIORITY||Absolute Difference|-0.4||||0.5|TWO_SIDED|95.0|-29.2|28.4|||Cochran-Mantel-Haenszel|||Plasmablast Signature Level Q2||28.4|-29.2|0.500
72619237|NCT06399471|144769074|OTHER|Non-parametric Friedman's test with multiple comparison correction||||||0.236|||||||Non-parametric Friedman's test with mult|||The Non-parametric Friedman's test was used to compare the survey results between the participants using the Power Knee and the Rheo.||||0.236
72619238|NCT06399471|144769074|OTHER|Non-parametric Friedman's test with multiple comparison correction||||||0.118|||||||Non-parametric Friedman's test with mult|||The Non-parametric Friedman's test was used to compare the survey results between the participants using the Rheo and the C-Leg 4.0.||||0.118
72497342|NCT02908100|144524520|SUPERIORITY||Absolute Difference|3.3||||0.234|TWO_SIDED|95.0|-27.1|33.8|||Cochran-Mantel-Haenszel|||Plasmablast Signature Level Q2||33.8|-27.1|0.234
72497343|NCT02908100|144524520|SUPERIORITY||Absolute Difference|15.5||||0.364|TWO_SIDED|95.0|-14.9|46.0|||Cochran-Mantel-Haenszel|||Plasmablast Signature Level Q3||46|-14.9|0.364
72497344|NCT02908100|144524520|SUPERIORITY||Absolute Difference|7.2||||0.31|TWO_SIDED|95.0|-22.0|36.3|||Cochran-Mantel-Haenszel|||Plasmablast Signature Level Q3||36.3|-22|0.310
72497345|NCT02908100|144524520|SUPERIORITY||Absolute Difference|-2.1||||0.922|TWO_SIDED|95.0|-32.5|28.2|||Cochran-Mantel-Haenszel|||Plasmablast Signature Level Q4||28.2|-32.5|0.922
72497346|NCT02908100|144524520|SUPERIORITY||Absolute Difference|-5.9||||0.701|TWO_SIDED|95.0|-35.4|23.7|||Cochran-Mantel-Haenszel|||Plasmablast Signature Level Q4||23.7|-35.4|0.701
72497347|NCT02908100|144524521|SUPERIORITY||Absolute Difference|3.1||||0.692|TWO_SIDED|95.0|-10.9|17.1|||Cochran-Mantel-Haenszel|||Week 24||17.1|-10.9|0.692
72444820|NCT04419168|144404204|SUPERIORITY||Mean Difference (Final Values)|0.11||||0.91|TWO_SIDED|95.0|-1.77|1.99|||Mixed Models Analysis|||These results correspond to ASCQ-Me Social Functioning Impact only.||1.99|-1.77|0.91
72444821|NCT04419168|144404204|SUPERIORITY||Mean Difference (Final Values)|1.72||||0.05|TWO_SIDED|95.0|-0.03|3.46|||Mixed Models Analysis|||These results correspond to ASCQ-Me Emotional Impact only.||3.46|-0.03|0.05
72444822|NCT04419168|144404205|SUPERIORITY||Mean Difference (Final Values)|1.13||||0.12|TWO_SIDED|95.0|-0.31|2.56|||Mixed Models Analysis|||||2.56|-0.31|0.12
72497348|NCT02908100|144524521|SUPERIORITY||Absolute Difference|1.9||||0.871|TWO_SIDED|95.0|-12.0|15.9|||Cochran-Mantel-Haenszel|||Week 24||15.9|-12|0.871
72560520|NCT04556734|144651431|OTHER||Response rate difference|-0.8||||0.9425|TWO_SIDED|95.0|-23.18|21.48||P-values were based on the comparison of etrasimod versus placebo.|Cochran-Mantel-Haenszel||Clopper-Pearson method|\>= 50% Improvement: Response rate difference was difference in response rates between DB Treatment period: Etrasimod 2 mg and DB Treatment period: Placebo||21.48|-23.18|0.9425
72444823|NCT04419168|144404206|SUPERIORITY||Mean Difference (Final Values)|-0.0024||||0.91|TWO_SIDED|95.0|-0.0443|0.0395|||Mixed Models Analysis|||||0.0395|-0.0443|0.91
72444824|NCT04419168|144404207|SUPERIORITY||Mean Difference (Final Values)|0.43||||0.68|TWO_SIDED|95.0|-1.61|2.48|||Mixed Models Analysis|||||2.48|-1.61|0.68
72444825|NCT04419168|144404208|SUPERIORITY||Mean Difference (Final Values)|0.09||||0.75|TWO_SIDED|95.0|-0.46|0.63|||Mixed Models Analysis|||||0.63|-0.46|0.75
72560521|NCT04556734|144651431|OTHER||Response rate difference|8.9||||0.4959|TWO_SIDED|95.0|-15.19|32.94||P-values were based on the comparison of etrasimod versus placebo.|Cochran-Mantel-Haenszel||Clopper-Pearson method|\>= 50% Improvement: Response rate difference was difference in response rates between DB Treatment period: Etrasimod 3 mg and DB Treatment period: Placebo||32.94|-15.19|0.4959
72444826|NCT04419168|144404209|SUPERIORITY||Mean Difference (Final Values)|-1.1||||0.14|TWO_SIDED|95.0|-2.56|0.35|||Mixed Models Analysis|||||0.35|-2.56|0.14
72444827|NCT04419168|144404210|SUPERIORITY||Mean Difference (Final Values)|-0.24||||0.75|TWO_SIDED|95.0|-1.69|1.21|||Mixed Models Analysis|||||1.21|-1.69|0.75
72444828|NCT04419168|144404211|SUPERIORITY||Mean Difference (Final Values)|0.71||||0.49|TWO_SIDED|95.0|-1.3|2.71|||Mixed Models Analysis|||These results correspond to ASCQ-Me Social Functioning Impact only.||2.71|-1.30|0.49
72444829|NCT04419168|144404211|SUPERIORITY||Mean Difference (Final Values)|2.0||||0.037|TWO_SIDED|95.0|0.12|3.88|||Mixed Models Analysis|||These results correspond to ASCQ-Me Emotional Impact only.||3.88|0.12|0.037
72444830|NCT04419168|144404212|SUPERIORITY||Mean Difference (Final Values)|2.13||||0.008|TWO_SIDED|95.0|0.56|3.71|||Mixed Models Analysis|||||3.71|0.56|0.008
72444831|NCT04419168|144404213|SUPERIORITY||Mean Difference (Final Values)|-0.34||||0.56|TWO_SIDED|95.0|-1.51|0.82|||Mixed Models Analysis|||||0.82|-1.51|0.56
72497349|NCT02908100|144524521|SUPERIORITY||Absolute Difference|11.2||||0.105|TWO_SIDED|95.0|-2.8|25.1|||Cochran-Mantel-Haenszel|||Week 48||25.1|-2.8|0.105
72497350|NCT02908100|144524521|SUPERIORITY||Absolute Difference|7.7||||0.286|TWO_SIDED|95.0|-6.1|21.6|||Cochran-Mantel-Haenszel|||Week 48||21.6|-6.1|0.286
72497351|NCT02908100|144524522|SUPERIORITY||Absolute Difference|-1.6||||0.936|TWO_SIDED|95.0|-16.8|13.6|||Cochran-Mantel-Haenszel|||Week 24||13.6|-16.8|0.936
72497352|NCT02908100|144524522|SUPERIORITY||Absolute Difference|-2.9||||0.683|TWO_SIDED|95.0|-18.2|12.4|||Cochran-Mantel-Haenszel|||Week 24||12.4|-18.2|0.683
72497353|NCT02908100|144524522|SUPERIORITY||Absolute Difference|11.7||||0.086|TWO_SIDED|95.0|-3.4|26.8|||Cochran-Mantel-Haenszel|||Week 48||26.8|-3.4|0.086
72497354|NCT02908100|144524522|SUPERIORITY||Absolute Difference|0.9||||0.879|TWO_SIDED|95.0|-14.2|16.1|||Cochran-Mantel-Haenszel|||Week 48||16.1|-14.2|0.879
72497355|NCT00464204|144524558|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-331.0|STANDARD_DEVIATION|1033.0||0.0185|TWO_SIDED|95.0|-640.0|-21.0||One-sided t-test assuming unequal variances (as variances were significantly different between treatment groups).No multiple comparisons were made. A priori threshold for statistical significance for the confirmatory analysis on FAS: 0.025 one-sided.|t-test, 1 sided||Considered difference: Voluven® minus NaCl 0.9 %|"Null-hypothesis: The amount of study drug required to achieve initial hemodynamic stabilization in patients treated with Voluven® is higher than or equal to this amount in patients treated with NaCl.~Alternative hypothesis: The amount of study drug required to achieve initial hemodynamic stabilization is lower in patients treated with Voluven® than in patients treated with NaCl."||-21|-640|0.0185
72497356|NCT03183128|144524647|SUPERIORITY||Risk Ratio (RR)|0.32|||<|0.001|TWO_SIDED|95.0|0.18|0.58||P-value presented for both hypothesis tests: H0: RR≥1 and H0: RR≥0.833.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test was stratified by age (\<65 years, ≥65 years) and prior antibiotic regimen (vancomycin, fidaxomicin).|RR defined as the recurrence rates of SER-109 divided by Placebo. Cochran-Mantel-Haenszel estimate of RR, stratified by age group (\<65 years, ≥65 years) and prior antibiotic regimen for the qualifying episode (vancomycin, fidaxomicin), is reported.|||0.58|0.18|<0.001
72497357|NCT03183128|144524648|SUPERIORITY||Hazard Ratio (HR)|0.35|||<|0.001|TWO_SIDED|95.0|0.19|0.67||P-value presented is for the hypothesis test: H0: RR ≥1.0.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel estimate is stratified by age (\<65 years, ≥65 years) and prior antibiotic regimen (vancomycin, fidaxomicin).|RR defined as the recurrence rates of SER-109 divided by Placebo. Cochran-Mantel-Haenszel estimate of RR, stratified by age group (\<65 years, ≥65 years) and prior antibiotic regimen for the qualifying episode (vancomycin, fidaxomicin), is reported.|CDI recurrence rates at Week 4||0.67|0.19|<0.001
72560522|NCT04556734|144651431|OTHER||Response rate difference|5.6||||0.3576|TWO_SIDED|95.0|-5.39|16.59||P-values are based on the comparison of Etrasimod versus placebo.|Cochran-Mantel-Haenszel||Clopper-Pearson method|\>= 75% Improvement: Response rate difference was difference in response rates between DB Treatment period: Etrasimod 2 mg and DB Treatment period: Placebo||16.59|-5.39|0.3576
72560523|NCT04556734|144651431|OTHER||Response rate difference|8.3||||0.2904|TWO_SIDED|95.0|-3.43|20.12||P-values were based on the comparison of etrasimod versus placebo.|Cochran-Mantel-Haenszel||Clopper-Pearson method|\>= 75% Improvement: Response rate difference was difference in response rates between DB Treatment period: Etrasimod 3 mg and DB Treatment period: Placebo.||20.12|-3.43|0.2904
72444832|NCT04419168|144404214|SUPERIORITY||Mean Difference (Final Values)|-0.0013||||0.95|TWO_SIDED|95.0|-0.0464|0.0437|||Mixed Models Analysis|||||0.0437|-0.0464|0.95
72444833|NCT04419168|144404215|SUPERIORITY||Incidence Rate Ratio|1.11||||0.49|TWO_SIDED|95.0|0.83|1.48|||Negative Binomial Regression|Adjustments were made for clinic site, baseline depression (high vs low), and corresponding health care use in the 12 months prior to study entry.||||1.48|0.83|0.49
72444834|NCT04419168|144404216|SUPERIORITY||Incidence Rate Ratio|1.43||||0.1|TWO_SIDED|95.0|0.93|2.18|||Negative Binomial Regression|Adjustments were made for clinic site, baseline depression (high vs low), and corresponding health care use in the 12 months prior to study entry.||||2.18|0.93|0.10
72444835|NCT04419168|144404217|SUPERIORITY||Incidence Rate Ratio|1.31||||0.22|TWO_SIDED|95.0|0.85|2.03|||Negative Binomial Regression|Adjustments were made for clinic site, baseline depression (high vs low), and corresponding health care use in the 12 months prior to study entry.||||2.03|0.85|0.22
72444836|NCT04490915|144404218|SUPERIORITY||LS Mean Difference|-17.022|STANDARD_ERROR_OF_MEAN|3.433|<|0.0001|TWO_SIDED|95.0|-23.802|-10.243|||ANCOVA||LS Mean Difference of Crinecerfont - Placebo|||-10.243|-23.802|<0.0001
72444837|NCT05009251|144404230|SUPERIORITY|||||||0.054|||||||Regression, Linear|||This analysis compared groups that were informed they were high risk (High Risk Only, High Risk Based on Medical Records, High Risk Based on Algorithm) to Reminder Control patients who were sent messages that did not disclose their risk status. Null hypothesis: messages that inform patients they are high risk do not increase flu vaccination rate vs. messages that do not disclose risk status; Alternative hypothesis: messages that inform patients they are high risk increase flu vaccination rate.||||.054
72444838|NCT05009251|144404230|SUPERIORITY||||||<|0.001|||||||Regression, Linear|||This analysis compared groups that were informed they were high risk (High Risk Only, High Risk Based on Medical Records, High Risk Based on Algorithm) to No-Contact Control patients who were not sent messages. Null hypothesis: messages that inform patients they are high risk do not increase flu vaccination rate relative to no messages; Alternative hypothesis: messages that inform patients they are high risk increase flu vaccination rate.||||<.001
72444839|NCT05009251|144404230|SUPERIORITY|||||||0.24|||||||Regression, Linear|||This analysis compared groups who received messages including risk reasons (High Risk Based on Medical Records, High Risk Based on Algorithm) to messages that mentioned patients' risk status but do not include reasons (High Risk Only). Null hypothesis: messages that include risk reasons do not increase flu vaccination rate relative to high-risk messages that do not include risk reasons; Alternative hypothesis: messages including risk reasons are more effective at increasing vaccination rates.||||.240
72444840|NCT05009251|144404230|SUPERIORITY|||||||0.047|||||||Regression, Linear|||Null hypothesis: flu-shot messages that do not mention high-risk status do not increase vaccination relative to no messages; Alternative hypothesis: flu shot messages that do not mention high-risk status increase flu shots relative to no messages.||||.047
72444841|NCT05009251|144404230|SUPERIORITY|||||||0.781||||||Pairwise comparisons between high-risk messages (Analyses 5, 6 and 7) were analyzed in the same regression. Reported p-values were adjusted using Tukey's HSD test.|Regression, Linear|||Null hypothesis: High Risk Only and High Risk Based on Medical Records messages are equally effective at promoting flu vaccinations; Alternative hypothesis: there is a difference in effectiveness between High Risk Only and High Risk Based on Medical Records.||||.781
72444842|NCT05009251|144404230|SUPERIORITY|||||||0.361||||||Pairwise comparisons between high-risk messages (Analyses 5, 6 and 7) were analyzed in the same regression. Reported p-values were adjusted using Tukey's HSD test.|Regression, Linear|||Null hypothesis: High Risk Only and High Risk Based on Algorithm messages are equally effective at promoting flu vaccinations; Alternative hypothesis: there is a difference in effectiveness between High Risk Only and High Risk Based on Algorithm.||||.361
72444843|NCT05009251|144404230|SUPERIORITY|||||||0.77||||||Pairwise comparisons between high-risk messages (Analyses 5, 6 and 7) were analyzed in the same regression. Reported p-values were adjusted using Tukey's HSD test.|Regression, Linear|||Null hypothesis: High Risk Based on Medical Records and High Risk Based on Algorithm messages are equally effective at promoting flu vaccinations; Alternative hypothesis: there is a difference in effectiveness between High Risk Based on Medical Records and High Risk Based on Algorithm.||||.770
72444844|NCT00616967|144404256|SUPERIORITY_OR_OTHER_LEGACY||Pathological complete response rate|0.274|||||TWO_SIDED|95.0|0.169|0.402|||||The Estimation Parameter provided above is for overall pCR for both arms combined. We estimated pCR for each arm separately as well.|Patients were stratified by hormone receptor status and randomly assigned to either arm 1 or 2. This study was designed using Simon's two-stage design for each arm in parallel. Interim analysis of early stopping for futility was conducted for the first 32 patients (16 patients per arm) and the study proceeded as more than 2 patients achieved a pCR in each arm (31 patients per arm). This design had 80% power to detect a 25% pCR rate versus a null rate of 10% with a type I error rate of 0.10.||0.402|0.169|
72444845|NCT00616967|144404256|SUPERIORITY_OR_OTHER_LEGACY||pCR in placebo arm (arm 1)|0.29|||||TWO_SIDED|95.0|0.142|0.48||||||||0.48|0.142|
72444846|NCT00616967|144404256|SUPERIORITY_OR_OTHER_LEGACY||pCR in vorinostat arm (arm 2)|0.258|||||TWO_SIDED|95.0|0.119|0.446||||||||0.446|0.119|
72444847|NCT00616967|144404259|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|5.1||||0.023|TWO_SIDED|95.0|1.3|22.7|||Regression, Logistic|||The estimates provided are based upon a multivariate analysis using a logistic regression adjusting for hormone receptor status. Patients with ≥50% reduction in SULmax were more likely to achieve a pCR.||22.7|1.3|0.023
72444848|NCT02910583|144404268|SUPERIORITY||Difference in Rates|4.7||||0.1475|TWO_SIDED|95.0|-1.6|10.9||P-value is from Z test for the difference of two proportions based on Kaplan-Meier estimates with standard error of each arm computed using Greenwood's formula.|Z test||comparison: ibrutininb vs. placebo|||10.9|-1.6|0.1475
72444849|NCT02910583|144404269|SUPERIORITY||||||<|0.0001||||||One-sided P-value from asymptotic test for the binomial proportion (CRR \<= 37% vs CRR \> 37%).|asymptotic test for binomial proportion|||||||< 0.0001
72444850|NCT05059262|144404298|SUPERIORITY||Difference in ORR|39.0|||<|0.0001|TWO_SIDED|95.0|28.4|49.6||Stratified by tumor location (lower limb/all other) and region (U.S./non-U.S.) based on Interactive Response Technology (IRT).|Cochran-Mantel-Haenszel||Stratified Mantel-Haenszel with stratification factors based on IRT|||49.6|28.4|<0.0001
72444851|NCT05059262|144404299|SUPERIORITY||Difference in ORR|67.2|||<|0.0001|TWO_SIDED|95.0|57.0|77.3||Stratified by tumor location (lower limb/all other) and region (U.S./non-U.S.) based on IRT.|Cochran-Mantel-Haenszel||Stratified Mantel-Haenszel with stratification factors based on IRT.|||77.3|57.0|<0.0001
72444852|NCT05059262|144404300|SUPERIORITY||LS Mean Difference|14.6||||0.0077|TWO_SIDED|95.0|4.0|25.3||Model included treatment+visit+treatment by visit interaction+stratification factor for region (U.S. versus non-U.S.)+joint type (knee, ankle, or other)+the most impaired ROM baseline value.|Mixed model repeated measures|||||25.3|4.0|0.0077
72444853|NCT05059262|144404301|SUPERIORITY||LS Mean Difference|3.3||||0.0007|TWO_SIDED|95.0|1.4|5.2||Model included treatment+visit+treatment by visit interaction+stratification factor for region (U.S. versus non-U.S.) and tumor location (lower limb/all other) based on IRT+PROMIS-PF baseline value.|Mixed model repeated measures|||||5.2|1.4|0.0007
72444854|NCT05059262|144404302|SUPERIORITY||LS Mean Difference|-1.8|||<|0.0001|TWO_SIDED|95.0|-2.5|-1.1||Model included treatment+visit+treatment by visit interaction+stratification factor for region (U.S. versus non-U.S.) and tumor location (lower limb/all other) based on IRT+Worst Stiffness NRS baseline value.|Mixed model repeated measures|||||-1.1|-2.5|<0.0001
72444855|NCT05059262|144404303|SUPERIORITY||LS Mean Difference|7.4||||0.0155|TWO_SIDED|95.0|1.4|13.4||Model included treatment+visit+treatment by visit interaction+stratification factor for region (U.S. versus non-U.S.) and tumor location (lower limb/all other) based on IRT+VAS baseline value.|Mixed model repeated measures|||||13.4|1.4|0.0155
72444856|NCT05059262|144404304|SUPERIORITY||Difference in responder rate|26.2||||0.0056|TWO_SIDED|95.0|9.5|42.8||Stratified by tumor location (lower limb/all other) and region (U.S./non-U.S.) based on IRT.|Cochran-Mantel-Haenszel||Stratified Mantel-Haenszel with stratification factors based on IRT.|||42.8|9.5|0.0056
72444857|NCT03205800|144404307|SUPERIORITY||||||<|0.05|||||||Wilcoxon signed rank test|||||||<0.05
72444858|NCT04501861|144404379|EQUIVALENCE|Compare mPAP-to-MAP ratio between patients who received norepinephrine versus vasopressin intraoperatively. Post intervention measurements will be recorded after protamine administration until end of chest closure.|Mean Difference (Final Values)|0.01||||0.53|TWO_SIDED|95.0|-0.043|0.022|||Mixed Models Analysis|||||0.022|-0.043|0.53
72444859|NCT04501861|144404379|EQUIVALENCE|Compare mPAP-to-MAP ratio between patients who with preop PH received norepinephrine versus vasopressin intraoperatively. Post intervention measurements will be recorded after protamine administration until end of chest closure. The number of patients in norepinephrine group is 52 and in vasopressin group is 40. The significance level was 0.05 for all analyses. All tests were 2-sided. Interactions were considered significant when the interaction P was \< 0.10.|Mean Difference (Final Values)|-0.022||||0.26|TWO_SIDED|95.0|-0.061|0.016|||Mixed Models Analysis|||mPAP-to-MAP ratio was compared between patients with pre-existing pulmonary hypertension of use of vasopressin and norepinephrine. Preoperative pulmonary arterial hypertension was defined by using the cut-off value of 25 mmHg for the time-weighted average mPAP, i.e., time weighted average mPAP \< 25 mmHg indicated absence of preoperative pulmonary arterial hypertension; otherwise, presence of preoperative pulmonary hypertension.||0.016|-0.061|0.26
72444860|NCT04501861|144404379|EQUIVALENCE|Compare mPAP-to-MAP ratio between patients who without preop PH received norepinephrine versus vasopressin intraoperatively. Post intervention measurements will be recorded after protamine administration until end of chest closure. The number of patients in norepinephrine group is 31 and in vasopressin group is 29. The significance level was 0.05 for all analyses. All tests were 2-sided. Interactions were considered significant when the interaction P was \< 0.10.|Mean Difference (Final Values)|-0.0035||||0.88|TWO_SIDED|95.0|-0.05|0.043|||Mixed Models Analysis|||mPAP-to-MAP ratio was compared between patients without pre-existing pulmonary hypertension of use of vasopressin and norepinephrine. Preoperative pulmonary arterial hypertension was defined by using the cut-off value of 25 mmHg for the time-weighted average mPAP, i.e., time weighted average mPAP \< 25 mmHg indicated absence of preoperative pulmonary arterial hypertension; otherwise, presence of preoperative pulmonary hypertension.||0.043|-0.05|0.88
72444861|NCT04501861|144404380|EQUIVALENCE|Imbalanced confounders such as female, coronary artery disease, preoperative ejection fraction, surgery type, primary or repeat surgery, and bypass time were additionally adjusted. A different inverse probability of treatment weighting was fit for secondary analysis and a linear mixed regression model with random intercept to account for intra-week correlation to estimate the effect of norepinephrine on right ventricular free wall strain using the new obtained stabilized weights|Mean Difference (Final Values)|-1.8||||0.37|TWO_SIDED|95.0|-6.0|2.3|||Mixed Models Analysis|||||2.3|-6.0|0.37
72504783|NCT03114969|144540510|SUPERIORITY||Odds Ratio (OR)|20.454||||0.038|TWO_SIDED|95.0|1.19|351.613||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Incruse/Anoro Ellipta as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.|||351.613|1.190|0.038
72504784|NCT03114969|144540510|SUPERIORITY||Odds Ratio (OR)|18.776||||0.041|TWO_SIDED|95.0|1.131|311.669||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Incruse/Anoro Ellipta as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.|||311.669|1.131|0.041
72504785|NCT03114969|144540510|SUPERIORITY||Odds Ratio (OR)|8.873||||0.141|TWO_SIDED|95.0|0.484|162.775||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.|||162.775|0.484|0.141
72444862|NCT04501861|144404380|EQUIVALENCE|We examined the effect of norepinephrine versus vasopressin on right ventricular free wall strain by considering patients who have preoperative pulmonary hypertension. The number of patients in norepinephrine group is 34 and in vasopressin group is 28. The significance level was 0.05 for all analyses. All tests were 2-sided. The significance levels of subgroup analyses were not corrected for multiple comparisons. Interactions were considered significant when the interaction P was \< 0.10.|Mean Difference (Final Values)|-2.1||||0.39|TWO_SIDED|95.0|-7.1|2.8|||Mixed Models Analysis|||RV free wall strain compare between patients with pre-existing pulmonary hypertension of use of vasopressin and norepinephrine. Preoperative pulmonary arterial hypertension was defined by using the cut-off value of 25 mmHg for the time-weighted average mPAP, i.e., time weighted average mPAP \< 25 mmHg indicated absence of preoperative pulmonary arterial hypertension; otherwise, presence of preoperative pulmonary hypertension;||2.8|-7.1|0.39
72444863|NCT04501861|144404380|EQUIVALENCE|We're going to explore the interaction between preoperative pulmonary arterial hypertension status and treatment group by equivalence analysis. The number of patients in norepinephrine group is 22 and in vasopressin group is 18.The significance level was 0.05 for all analyses. All tests were 2-sided. The significance levels of subgroup analyses were not corrected for multiple comparisons. Interactions were considered significant when the interaction P was \< 0.10.|Mean Difference (Final Values)|-1.5||||0.63|TWO_SIDED|95.0|-7.6|4.6|||Mixed Models Analysis|||"We examined the effect of norepinephrine versus vasopressin on right ventricular free wall strain by separately considering patients who did not have preoperative pulmonary hypertension.~Preoperative pulmonary arterial hypertension was defined by using the cut-off value of 25 mmHg for the time-weighted average mPAP, i.e., time weighted average mPAP \< 25 mmHg indicated absence of preoperative pulmonary arterial hypertension; otherwise, presence of preoperative pulmonary hypertension."||4.6|-7.6|0.63
72444864|NCT01007591|144404417|SUPERIORITY||Mean Difference (Final Values)|-6.02||||0.75|TWO_SIDED|95.0|-43.7|31.7|||ANOVA|Treatment comparison using an ANOVA model with age group and treatment as design variables.||||31.7|-43.7|0.75
72444865|NCT02549339|144404422|SUPERIORITY||Ratio of clearance rates|7.57||||0.001|TWO_SIDED|95.0|2.26|25.31|||Mantel Haenszel||Mantel-Haenszel estimate (0.018% relative to vehicle), adjusted for pooled sites.|||25.31|2.26|0.001
72444866|NCT02549339|144404423|SUPERIORITY||Ratio of clearance rates|5.9|||<|0.001|TWO_SIDED|95.0|3.3|10.54|||Mantel Haenszel||Mantel-Haenszel estimate (0.018% relative to vehicle), adjusted for pooled sites.|The p-values for secondary endpoints have been corrected by the Holm-Bonferroni method to account for multiplicity. The prespecified multiplicity adjustment by the Holm-Bonferroni method requires the ordering of the p-values for the secondary endpoints by size.||10.54|3.30|<0.001
72444867|NCT02549339|144404424|SUPERIORITY||Ratio of clearance rates|5.75|||<|0.001|TWO_SIDED|95.0|3.24|10.2|||Mantel Haenszel||Mantel-Haenszel estimate (0.018% relative to vehicle), adjusted for pooled sites.|The p-values for secondary endpoints have been corrected by the Holm-Bonferroni method to account for multiplicity. The prespecified multiplicity adjustment by the Holm-Bonferroni method requires the ordering of the p-values for the secondary endpoints by size.||10.20|3.24|<0.001
72444868|NCT02549339|144404425|SUPERIORITY||Week 8 AK count ratio|0.3|||<|0.001|TWO_SIDED|95.0|0.25|0.35||Negative binominal regression with treatment group and pooled site as factors and log baseline count as offset variable.|Mantel Haenszel||0.018% relative to vehicle.|The p-values for secondary endpoints have been corrected by the Holm-Bonferroni method to account for multiplicity. The prespecified multiplicity adjustment by the Holm-Bonferroni method requires the ordering of the p-values for the secondary endpoints by size.||0.35|0.25|<0.001
72444869|NCT02724878|144404436|SUPERIORITY||Response Rate|33.0|||||TWO_SIDED|80.0|25.0|42.0||||||A sample size of 60 would provide 95% power to distinguish the ORR rate of 25% from 10% (historical control) with 1-sided alpha of 0.07. The treatment would be considered effective if 10 or more responses are observed out of 60 patients.||42|25|
72444870|NCT04838262|144404463|OTHER|||||||0.57|||||||Regression, Linear|||||||0.57
72444871|NCT04838262|144404463|OTHER|||||||0.85|||||||Regression, Linear|||||||0.85
72560524|NCT01680016|144651434|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was achieved if the lower limit of the two-sided 95% CI around the observed ratio of GMCs between the groups (GMCGroup Zagreb / GMCGroup Essen) was greater than 0.5|Ratio of GMCs between two groups(Day 15)|0.84|||||TWO_SIDED|95.0|0.69|1.02|||ANOVA|||To demonstrate noninferiority in immune response of the Zagreb post-exposure schedule of Rabipur to that of the conventional Essen post-exposure schedule at day 15 in children aged ≥6 to ≤17 years||1.02|0.69|
72444872|NCT03175029|144404465|SUPERIORITY||Mean Difference (Final Values)|10.552|||<|0.001|TWO_SIDED|95.0|5.514|15.59|||t-test, 2 sided|||Baseline vs. Week 12 for the mean BCI in the TAC-302 group||15.590|5.514|<0.001
72497358|NCT03183128|144524648|SUPERIORITY||Hazard Ratio (HR)|0.4|||<|0.001|TWO_SIDED|95.0|0.24|0.65||P-value presented is for the hypothesis test: H0: RR ≥1.0.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel estimate is stratified by age (\<65 years, ≥65 years) and prior antibiotic regimen (vancomycin, fidaxomicin).|RR defined as the recurrence rates of SER-109 divided by Placebo. Cochran-Mantel-Haenszel estimate of RR, stratified by age group (\<65 years, ≥65 years) and prior antibiotic regimen for the qualifying episode (vancomycin, fidaxomicin), is reported.|CDI recurrence rates at Week 12||0.65|0.24|<0.001
72444873|NCT03175029|144404465|SUPERIORITY||Mean Difference (Final Values)|-0.826||||0.819|TWO_SIDED|95.0|-8.676|7.023|||t-test, 2 sided|||Baseline vs. Week 12 for the mean BCI in the Placebo group||7.023|-8.676|0.819
72444874|NCT03175029|144404465|SUPERIORITY||Mean Difference (Final Values)|11.378|STANDARD_ERROR_OF_MEAN|4.454||0.015|TWO_SIDED|95.0|2.345|20.411|||t-test, 2 sided|||TAC-302 group vs. Placebo group for changes in the mean BCI from baseline to Week 12||20.411|2.345|0.015
72444875|NCT03175029|144404466|SUPERIORITY||Mean Difference (Final Values)|10.604|STANDARD_DEVIATION|8.76|<|0.001|TWO_SIDED|95.0|5.753|15.455|||t-test, 2 sided|||Baseline vs. Week 12 for the mean PIP1 in the TAC-302 group||15.455|5.753|<0.001
72444876|NCT03175029|144404466|SUPERIORITY||Mean Difference (Final Values)|4.926|STANDARD_DEVIATION|7.62||0.138|TWO_SIDED|95.0|-2.121|11.973|||t-test, 2 sided|||Baseline vs. Week 12 for the mean PIP1 in the Placebo group||11.973|-2.121|0.138
72444877|NCT03175029|144404466|SUPERIORITY||Mean Difference (Final Values)|5.678|STANDARD_ERROR_OF_MEAN|3.861||0.157|TWO_SIDED|95.0|-2.375|13.731|||t-test, 2 sided|||TAC-302 group vs. Placebo group for changes in the mean PIP1 from baseline to Week 12||13.731|-2.375|0.157
72444878|NCT03175029|144404467|SUPERIORITY||Mean Difference (Final Values)|10.91|STANDARD_DEVIATION|26.48||0.006|TWO_SIDED|95.0|3.22|18.59|||t-test, 2 sided|||Baseline vs. Week 12 for the mean BVE in the TAC-302 group||18.59|3.22|0.006
72389231|NCT02499783|144286558|SUPERIORITY||Adjusted Risk Difference|33.4|||<|0.001|TWO_SIDED|95.0|23.2|43.6||Based on Cochran-Mantel-Haenszel test stratified by Crohn's disease severity (CDAI \<= 300 and CDAI \>300) at baseline and corticosteroid use at baseline.|Cochran-Mantel-Haenszel||Risk difference = (adalimumab 160/80 mg - placebo). Based on Cochran-Mantel-Haenszel test stratified by Crohn's disease severity (CDAI \<= 300 and CDAI \>300) at baseline and corticosteroid use at baseline.|Clinical Remission (CDAI \< 150) Plus A Reduction in HS-CRP of at Least 50% From Baseline at Week 4||43.6|23.2|< 0.001
72389232|NCT02499783|144286560|SUPERIORITY||Adjusted Risk Difference|21.7||||0.001|TWO_SIDED|95.0|8.7|34.6||Based on Cochran-Mantel-Haenszel test stratified by Crohn's disease severity (CDAI \<= 300 and CDAI \>300) at baseline and corticosteroid use at baseline.|Cochran-Mantel-Haenszel||Risk difference = (adalimumab 160/80 mg - placebo). Based on Cochran-Mantel-Haenszel test stratified by Crohn's disease severity (CDAI \<= 300 and CDAI \>300) at baseline and corticosteroid use at baseline.|Clinical Response (Decrease in CDAI ≥ 70 Points From Baseline) at Week 2||34.6|8.7|0.001
72389233|NCT02499783|144286560|SUPERIORITY||Adjusted Risk Difference|40.4|||<|0.001|TWO_SIDED|95.0|26.7|54.2||Based on Cochran-Mantel-Haenszel test stratified by Crohn's disease severity (CDAI \<= 300 and CDAI \>300) at baseline and corticosteroid use at baseline.|Cochran-Mantel-Haenszel||Risk difference = (adalimumab 160/80 mg - placebo). Based on Cochran-Mantel-Haenszel test stratified by Crohn's disease severity (CDAI \<= 300 and CDAI \>300) at baseline and corticosteroid use at baseline.|Clinical Response (Decrease in CDAI ≥ 70 Points From Baseline) at Week 4||54.2|26.7|< 0.001
72389234|NCT02499783|144286562|SUPERIORITY||Adjusted Risk Difference|31.4|||<|0.001|TWO_SIDED|95.0|19.6|43.2||Based on Cochran-Mantel-Haenszel test stratified by Crohn's disease severity (CDAI \<= 300 and CDAI \>300) at baseline and corticosteroid use at baseline.|Cochran-Mantel-Haenszel||Risk difference = (adalimumab 160/80 mg - placebo). Based on Cochran-Mantel-Haenszel test stratified by Crohn's disease severity (CDAI \<= 300 and CDAI \>300) at baseline and corticosteroid use at baseline.|Decrease in CDAI ≥ 70 Points From Baseline Plus a Reduction in Hs-CRP of at Least 30% From Baseline at Week 2||43.2|19.6|< 0.001
72389235|NCT02499783|144286562|SUPERIORITY||Adjusted Risk Difference|50.2|||<|0.001|TWO_SIDED|95.0|36.9|63.5||Based on Cochran-Mantel-Haenszel test stratified by Crohn's disease severity (CDAI \<= 300 and CDAI \>300) at baseline and corticosteroid use at baseline.|Cochran-Mantel-Haenszel||Risk difference = (adalimumab 160/80 mg - placebo). Based on Cochran-Mantel-Haenszel test stratified by Crohn's disease severity (CDAI \<= 300 and CDAI \>300) at baseline and corticosteroid use at baseline.|Decrease in CDAI ≥ 70 Points From Baseline Plus a Reduction in Hs-CRP of at Least 30% From Baseline at Week 4||63.5|36.9|< 0.001
72389236|NCT02499783|144286564|SUPERIORITY||Least Squares Mean Difference|-43.34|||<|0.001|TWO_SIDED|95.0|-59.39|-27.3||P-value for test of difference between adalimumab and placebo for mean change from Baseline using ANCOVA with Treatment, Crohn's disease severity (CDAI \<= 300, \> 300) at Baseline and corticosteroid use at Baseline, and Baseline value as covariate.|ANCOVA|||Change From Baseline in CDAI at Week 2||-27.30|-59.39|< 0.001
72389237|NCT02499783|144286564|SUPERIORITY||Least Squares Mean Difference|-66.63|||<|0.001|TWO_SIDED|95.0|-84.2|-49.06||P-value for test of difference between adalimumab and placebo for mean change from Baseline using ANCOVA with Treatment, Crohn's disease severity (CDAI \<= 300, \> 300) at Baseline and corticosteroid use at Baseline, and Baseline value as covariate.|ANCOVA|||Change From Baseline in CDAI at Week 4||-49.06|-84.20|< 0.001
72389238|NCT02499783|144286566|SUPERIORITY||Least Squares Mean Difference|-13.921|||<|0.001|TWO_SIDED|95.0|-19.183|-8.659||P-value for test of difference between adalimumab and placebo for mean change from Baseline using ANCOVA with Treatment, Crohn's disease severity (CDAI \<= 300, \> 300) at Baseline and corticosteroid use at Baseline, and Baseline value as covariate.|ANCOVA|||Change From Baseline in hs-CRP Level at Week 2||-8.659|-19.183|< 0.001
72389239|NCT02499783|144286566|SUPERIORITY||Least Squares Mean Difference|-16.844|||<|0.001|TWO_SIDED|95.0|-21.206|-12.483||P-value for test of difference between adalimumab and placebo for mean change from Baseline using ANCOVA with Treatment, Crohn's disease severity (CDAI \<= 300, \> 300) at Baseline and corticosteroid use at Baseline, and Baseline value as covariate.|ANCOVA|||Change From Baseline in hs-CRP Level at Week 4||-12.483|-21.206|< 0.001
72389240|NCT00555971|144286578|EQUIVALENCE|This was a statistical analysis to address the null hypothesis that there was no difference between treatment and placebo groups.||||||0.036|||||||Fisher Exact|||||||0.036
72389241|NCT02571777|144286592|SUPERIORITY||LS Mean|0.065|STANDARD_ERROR_OF_MEAN|0.0176|<|0.001|TWO_SIDED|95.0|0.031|0.099|||Mixed Model for Repeated Measures (MMRM)|||||0.099|0.031|<0.001
72389242|NCT02571777|144286592|SUPERIORITY||LS Mean|0.076|STANDARD_ERROR_OF_MEAN|0.0176|<|0.001|TWO_SIDED|95.0|0.041|0.111|||MMRM|||||0.111|0.041|<0.001
72389243|NCT02571777|144286593|SUPERIORITY||LS Mean|0.014|STANDARD_ERROR_OF_MEAN|0.0406||0.729|TWO_SIDED|95.0|-0.066|0.094|||MMRM|||Week 26||0.094|-0.066|0.729
72389244|NCT02571777|144286593|SUPERIORITY||LS Mean|-0.086|STANDARD_ERROR_OF_MEAN|0.0404||0.034|TWO_SIDED|95.0|-0.165|-0.006|||MMRM|||Week 26||-0.006|-0.165|0.034
72389245|NCT02571777|144286593|SUPERIORITY||LS Mean|-0.071|STANDARD_ERROR_OF_MEAN|0.0409||0.085|TWO_SIDED|95.0|-0.151|0.01|||MMRM|||Week 26||0.010|-0.151|0.085
72389246|NCT02571777|144286593|SUPERIORITY||LS Mean|-0.084|STANDARD_ERROR_OF_MEAN|0.0406||0.038|TWO_SIDED|95.0|-0.164|-0.005|||MMRM|||Week 26||-0.005|-0.164|0.038
72389247|NCT02571777|144286593|SUPERIORITY||LS Mean|-0.059|STANDARD_ERROR_OF_MEAN|0.0415||0.157|TWO_SIDED|95.0|-0.14|0.023|||MMRM|||Week 52||0.023|-0.140|0.157
72389248|NCT02571777|144286593|SUPERIORITY||LS Mean|-0.121|STANDARD_ERROR_OF_MEAN|0.0414||0.003|TWO_SIDED|95.0|-0.202|-0.04|||MMRM|||Week 52||-0.040|-0.202|0.003
72389249|NCT02571777|144286593|SUPERIORITY||LS Mean|-0.01|STANDARD_ERROR_OF_MEAN|0.042||0.814|TWO_SIDED|95.0|-0.092|0.072|||MMRM|||Week 52||0.072|-0.092|0.814
72389250|NCT02571777|144286593|SUPERIORITY||LS Mean|0.008|STANDARD_ERROR_OF_MEAN|0.0416||0.845|TWO_SIDED|95.0|-0.073|0.09|||MMRM|||Week 52||0.090|-0.073|0.845
72389251|NCT02571777|144286594|SUPERIORITY||LS Mean|0.119|STANDARD_ERROR_OF_MEAN|0.0177|<|0.001|TWO_SIDED|95.0|0.085|0.154|||MMRM|||||0.154|0.085|<0.001
72389252|NCT02571777|144286594|SUPERIORITY||LS Mean|0.099|STANDARD_ERROR_OF_MEAN|0.0177|<|0.001|TWO_SIDED|95.0|0.064|0.133|||MMRM|||||0.133|0.064|<0.001
72389253|NCT02571777|144286595|SUPERIORITY||LS Mean|0.086|STANDARD_ERROR_OF_MEAN|0.0176|<|0.001|TWO_SIDED|95.0|0.051|0.12|||MMRM|||||0.120|0.051|<0.001
72444879|NCT03175029|144404467|SUPERIORITY||Mean Difference (Final Values)|2.42|STANDARD_DEVIATION|20.09||0.57|TWO_SIDED|95.0|-6.27|11.1|||t-test, 2 sided|||Baseline vs. Week 12 for the mean BVE in the Placebo group||11.10|-6.27|0.570
72444880|NCT03175029|144404467|SUPERIORITY||Mean Difference (Final Values)|8.49|STANDARD_ERROR_OF_MEAN|6.24||0.178|TWO_SIDED|95.0|-3.96|20.95|||t-test, 2 sided|||TAC-302 group vs. Placebo group for changes in the mean BVE from baseline to Week 12||20.95|-3.96|0.178
72560525|NCT01680016|144651435|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was achieved if the lower limit of the two-sided 95% CI around the observed ratio of GMCs between the groups (GMCGroup Zagreb / GMCGroup Essen) was greater than 0.5|Ratio of GMCs between two groups(Day 15)|1.09|||||TWO_SIDED|95.0|0.87|1.35|||ANOVA|||To demonstrate noninferiority in immune response of the Zagreb post-exposure schedule of Rabipur to that of the conventional Essen post-exposure schedule at day 15 in older adults aged ≥51 years||1.35|0.87|
72444881|NCT03175029|144404468|SUPERIORITY||Mean Difference (Final Values)|18.41|STANDARD_DEVIATION|24.39|<|0.001|TWO_SIDED|95.0|9.13|27.69|||t-test, 2 sided|||Baseline vs. Week 12 for the mean BVE in the TAC-302 group||27.69|9.13|<0.001
72444882|NCT03175029|144404468|SUPERIORITY||Mean Difference (Final Values)|2.88|STANDARD_DEVIATION|15.7||0.489|TWO_SIDED|95.0|-5.81|11.58|||t-test, 2 sided|||Baseline vs. Week 12 for the mean BVE in the Placebo group||11.58|-5.81|0.489
72444883|NCT03175029|144404468|SUPERIORITY||Mean Difference (Final Values)|15.53|STANDARD_ERROR_OF_MEAN|6.96||0.031|TWO_SIDED|95.0|1.48|29.58|||t-test, 2 sided|||TAC-302 group vs. Placebo group for changes in the mean BVE from baseline to Week 12||29.58|1.48|0.031
72444884|NCT03175029|144404469|SUPERIORITY||Mean Difference (Final Values)|23.57|STANDARD_DEVIATION|25.54|<|0.001|TWO_SIDED|95.0|11.26|35.88|||t-test, 2 sided|||Baseline vs. Week 12 for the mean BVE in the TAC-302 group||35.88|11.26|<0.001
72444885|NCT03175029|144404469|SUPERIORITY||Mean Difference (Final Values)|2.1|STANDARD_DEVIATION|17.18||0.708|TWO_SIDED|95.0|-10.19|14.4|||t-test, 2 sided|||Baseline vs. Week 12 for the mean BVE in the Placebo group||14.40|-10.19|0.708
72444886|NCT03175029|144404469|SUPERIORITY||Mean Difference (Final Values)|21.47|STANDARD_ERROR_OF_MEAN|9.02||0.025|TWO_SIDED|95.0|2.96|39.98|||t-test, 2 sided|||TAC-302 group vs. Placebo group for changes in the mean BVE from baseline to Week 12||39.98|2.96|0.025
72444887|NCT04382898|144404494|SUPERIORITY|||||||0.1041|||||||Fisher Exact|||||||0.1041
72444888|NCT04382898|144404500|SUPERIORITY|||||||0.0541|||||||Binomial test|||||||0.0541
72444889|NCT05229120|144404501|SUPERIORITY||Mean Difference (Final Values)|1.24||||0.124|ONE_SIDED||||||t-test, 1 sided|No adjustments were made. DF = 10.||A single-sided paired-samples t-test comparing k-values at baseline to k-values at follow-up (approximately 4 weeks after baseline assessment) was examined. Given that k-values are typically skewed (and to be consistent with the existing literature) we used a log-k as our outcome variable.||||.124
72444890|NCT05229120|144404502|SUPERIORITY||Mean Difference (Final Values)|1.13||||0.219|TWO_SIDED||||||t-test, 1 sided|No adjustments were made. DF = 14.||Changes in consideration of future consequences (parenting) was evaluated using one-sided paired samples t-tests.||||.219
72444891|NCT05229120|144404503|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.5|TWO_SIDED||||||t-test, 1 sided|No adjustments were made. DF = 5||Performed a one-sided paired samples t-test examining changes in both positive parenting.||||.50
72444892|NCT05229120|144404503|SUPERIORITY||Mean Difference (Final Values)|-1.0||||0.187|TWO_SIDED||||||t-test, 1 sided|||Used a one-sided paired samples t-test to examine changes in negative parenting.||||.187
72444893|NCT05229120|144404504|SUPERIORITY||Mean Difference (Final Values)|-0.01||||0.498|TWO_SIDED||||||t-test, 1 sided|||Examined changes in parental involvement using a paired-samples t-test.||||.498
72444894|NCT05229120|144404504|SUPERIORITY||Mean Difference (Final Values)|1.301||||0.108|TWO_SIDED||||||t-test, 1 sided|||Examined changes in positive parenting using paired samples t-tests||||.108
72444895|NCT05229120|144404504|SUPERIORITY||Mean Difference (Final Values)|-1.01||||0.145|TWO_SIDED||||||t-test, 1 sided|||Examined changes in parental monitoring using a paired samples t-test||||.145
72560526|NCT00202839|144651446|SUPERIORITY_OR_OTHER|||||||0.1651||95.0|||||Chi-squared|||||||0.1651
72444896|NCT05229120|144404504|SUPERIORITY||Mean Difference (Final Values)|-0.688||||0.252|TWO_SIDED||||||t-test, 1 sided|||Examined changes in inconsistent parenting using a paired samples one-sided t-test||||.252
72444897|NCT05229120|144404504|SUPERIORITY||Mean Difference (Final Values)|0.306||||0.382|TWO_SIDED||||||t-test, 1 sided|||Examined changes in corporal punishment using a paired samples one-tailed t-test||||.382
72444898|NCT03932682|144404513|OTHER|The primary objective would be achieved if efficacy was demonstrated for at least one of the two primary efficacy endpoints, that is, if the interim analysis-adjusted lower limit of the two-sided confidence interval (CI) for absolute vaccine efficacy (aVE) of QIVc versus the comparator vaccine was greater than 0%.|Cox Proportional Hazard|41.26|||||TWO_SIDED|97.98|21.55|56.02||||||||56.02|21.55|
72444899|NCT03932682|144404514|OTHER|The primary objective would be achieved if efficacy was demonstrated for at least one of the two primary efficacy endpoints, that is, if the interim analysis-adjusted lower limit of the two-sided CI for aVE of QIVc versus the comparator vaccine was greater than 0%.|Cox Proportional Hazard|46.9|||||TWO_SIDED|97.5|19.19|65.11||||||||65.11|19.19|
72444900|NCT03932682|144404515|OTHER|The secondary efficacy objectives were not associated with any hypothesis testing|Cox Proportional Hazard|54.49|||||TWO_SIDED|95.0|22.55|73.26||||||||73.26|22.55|
72444901|NCT03932682|144404516|OTHER|The secondary efficacy objectives were not associated with any hypothesis testing|Cox Proportional Hazard|50.67|||||TWO_SIDED|95.0|32.83|63.77||||||||63.77|32.83|
72444902|NCT03932682|144404517|OTHER|The secondary efficacy objectives were not associated with any hypothesis testing|Cox Proportional Hazard|100.0|||||TWO_SIDED|95.0|||||||"The 2-sided 95% confidence interval was calculated with a lower limit of not estimable and an upper limit of 100."|||||
72444903|NCT01566695|144404528|SUPERIORITY||Rate Difference|18.9||||0.0005|TWO_SIDED|95.0|8.3|29.6||2 sided|Stratified Mantel-Haenszel Chi-squared|Stratified by average baseline (BL) RBC tfx needs: ≤4 vs \>4 units of RBC per 28 days; BL platelet tfx status: dependent or ind. \&ECOG PS: 0 to 1 vs 2||||29.6|8.3|0.0005
72444904|NCT01566695|144404532|SUPERIORITY||Rate Difference|21.6|||<|0.0001|TWO_SIDED|95.0|11.9|31.3||2 sided|Stratified Mantel-Haenszel; Chi-squared|Stratified by average baseline (BL) RBC tfx needs: ≤4 vs \>4 units of RBC per 28 days; BL platelet tfx status: dependent or ind. \&ECOG PS: 0 to 1 vs 2||||31.3|11.9|<0.0001
72444905|NCT01566695|144404533|SUPERIORITY|||||||0.4347|||||||Two-Sided Unstratified Log Rank Test|||||||0.4347
72619239|NCT06399471|144769075|OTHER|One-way Repeated Measures ANOVA with sphericity correction (Huynh-Feldt) applied if necessary.||||||0.687|||||||ANOVA|||An ANOVA was used to compare the Power Knee, the C-Leg 4.0, and the Rheo when used during Stance Time Asymmetry Index test.||||0.687
72560527|NCT00288704|144651469|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|Comparison of p-value was a parametric ANCOVA main effects model with part A Baseline variable as covariate and treatment.||The sample size calculations at the time suggested 50 subjects would be enrolled at baseline. The Full Analysis Set (FAS) was used. The FAS included subjects who received at least one dose of rilonacept. Last observation carried forward was used.||||<.0001
72619240|NCT06399471|144769076|OTHER|One-way Repeated Measures ANOVA with sphericity correction (Huynh-Feldt) applied if necessary.||||||0.082|||||||ANOVA|||An ANOVA was used to compare the Power Knee, the C-Leg 4.0, and Rheo when used during the Narrowing beam walking test.||||0.082
72389254|NCT02571777|144286595|SUPERIORITY||LS Mean|0.145|STANDARD_ERROR_OF_MEAN|0.0178|<|0.001|TWO_SIDED|95.0|0.111|0.18|||MMRM|||||0.180|0.111|<0.001
72389255|NCT02571777|144286595|SUPERIORITY||LS Mean|0.062|STANDARD_ERROR_OF_MEAN|0.0178|<|0.001|TWO_SIDED|95.0|0.027|0.096|||MMRM|||||0.096|0.027|<0.001
72389256|NCT02571777|144286595|SUPERIORITY||LS Mean|0.087|STANDARD_ERROR_OF_MEAN|0.0179|<|0.001|TWO_SIDED|95.0|0.052|0.122|||MMRM|||||0.122|0.052|<0.001
72389257|NCT02571777|144286596|SUPERIORITY||LS Mean|0.073|STANDARD_ERROR_OF_MEAN|0.0218|<|0.001|TWO_SIDED|95.0|0.03|0.116|||MMRM|||Week 4||0.116|0.030|<0.001
72389258|NCT02571777|144286596|SUPERIORITY||LS Mean|0.139|STANDARD_ERROR_OF_MEAN|0.0217|<|0.001|TWO_SIDED|95.0|0.096|0.181|||MMRM|||Week 4||0.181|0.096|<0.001
72389259|NCT02571777|144286596|SUPERIORITY||LS Mean|0.039|STANDARD_ERROR_OF_MEAN|0.022||0.074|TWO_SIDED|95.0|-0.004|0.082|||MMRM|||Week 4||0.082|-0.004|0.074
72389260|NCT02571777|144286596|SUPERIORITY||LS Mean|0.108|STANDARD_ERROR_OF_MEAN|0.0219|<|0.001|TWO_SIDED|95.0|0.065|0.15|||MMRM|||Week 4||0.150|0.065|<0.001
72389261|NCT02571777|144286596|SUPERIORITY||LS Mean|0.056|STANDARD_ERROR_OF_MEAN|0.0219||0.01|TWO_SIDED|95.0|0.014|0.099|||MMRM|||Week 12||0.099|0.014|0.010
72389262|NCT02571777|144286596|SUPERIORITY||LS Mean|0.102|STANDARD_ERROR_OF_MEAN|0.0218|<|0.001|TWO_SIDED|95.0|0.059|0.145|||MMRM|||Week 12||0.145|0.059|<0.001
72389263|NCT02571777|144286596|SUPERIORITY||LS Mean|0.05|STANDARD_ERROR_OF_MEAN|0.0221||0.022|TWO_SIDED|95.0|0.007|0.094|||MMRM|||Week 12||0.094|0.007|0.022
72389264|NCT02571777|144286596|SUPERIORITY||LS Mean|0.099|STANDARD_ERROR_OF_MEAN|0.022|<|0.001|TWO_SIDED|95.0|0.056|0.142|||MMRM|||Week 12||0.142|0.056|<0.001
72389265|NCT02571777|144286597|SUPERIORITY||LS Mean|0.095|STANDARD_ERROR_OF_MEAN|0.0254|<|0.001|TWO_SIDED|95.0|0.045|0.145|||MMRM|||||0.145|0.045|<0.001
72389266|NCT02571777|144286597|SUPERIORITY||LS Mean|0.147|STANDARD_ERROR_OF_MEAN|0.0256|<|0.001|TWO_SIDED|95.0|0.097|0.198|||MMRM|||||0.198|0.097|<0.001
72389267|NCT02571777|144286597|SUPERIORITY||LS Mean|0.049|STANDARD_ERROR_OF_MEAN|0.0256||0.057|TWO_SIDED|95.0|-0.001|0.099|||MMRM|||||0.099|-0.001|0.057
72389268|NCT02571777|144286597|SUPERIORITY||LS Mean|0.056|STANDARD_ERROR_OF_MEAN|0.0258||0.029|TWO_SIDED|95.0|0.006|0.107|||MMRM|||||0.107|0.006|0.029
72389269|NCT02571777|144286598|SUPERIORITY||LS Mean|18.2|STANDARD_ERROR_OF_MEAN|2.59|<|0.001|TWO_SIDED|95.0|13.2|23.3|||Linear Mixed Model (LMM)|||Week 26 - Mean morning PEF||23.3|13.2|<0.001
72389270|NCT02571777|144286598|SUPERIORITY||LS Mean|35.3|STANDARD_ERROR_OF_MEAN|2.58|<|0.001|TWO_SIDED|95.0|30.2|40.3|||LMM|||Week 26 - Mean morning PEF||40.3|30.2|<0.001
72389271|NCT02571777|144286598|SUPERIORITY||LS Mean|14.9|STANDARD_ERROR_OF_MEAN|2.61|<|0.001|TWO_SIDED|95.0|9.8|20.0|||LMM|||Week 26 - Mean morning PEF||20.0|9.8|<0.001
72389272|NCT02571777|144286598|SUPERIORITY||LS Mean|28.0|STANDARD_ERROR_OF_MEAN|2.6|<|0.001|TWO_SIDED|95.0|22.9|33.1|||LMM|||Week 26 - Mean morning PEF||33.1|22.9|<0.001
72389273|NCT02571777|144286598|SUPERIORITY||LS Mean|16.8|STANDARD_ERROR_OF_MEAN|2.53|<|0.001|TWO_SIDED|95.0|11.8|21.7|||LMM|||Week 26 - Mean evening PEF||21.7|11.8|<0.001
72389274|NCT02571777|144286598|SUPERIORITY||LS Mean|29.1|STANDARD_ERROR_OF_MEAN|2.53|<|0.001|TWO_SIDED|95.0|24.2|34.1|||LMM|||Week 26 - Mean evening PEF||34.1|24.2|<0.001
72389275|NCT02571777|144286598|SUPERIORITY||LS Mean|14.1|STANDARD_ERROR_OF_MEAN|2.55|<|0.001|TWO_SIDED|95.0|9.1|19.1|||LMM|||Week 26 - Mean evening PEF||19.1|9.1|<0.001
72389276|NCT02571777|144286598|SUPERIORITY||LS Mean|24.3|STANDARD_ERROR_OF_MEAN|2.54|<|0.001|TWO_SIDED|95.0|19.3|29.3|||LMM|||Week 26 - Mean evening PEF||29.3|19.3|<0.001
72389277|NCT02571777|144286598|SUPERIORITY||LS Mean|18.7|STANDARD_ERROR_OF_MEAN|2.72|<|0.001|TWO_SIDED|95.0|13.4|24.1|||LMM|||Week 52 - Mean morning PEF||24.1|13.4|<0.001
72389278|NCT02571777|144286598|SUPERIORITY||LS Mean|34.8|STANDARD_ERROR_OF_MEAN|2.7|<|0.001|TWO_SIDED|95.0|29.5|40.1|||LMM|||Week 52 - Mean morning PEF||40.1|29.5|<0.001
72389279|NCT02571777|144286598|SUPERIORITY||LS Mean|15.6|STANDARD_ERROR_OF_MEAN|2.74|<|0.001|TWO_SIDED|95.0|10.2|20.9|||LMM|||Week 52 - Mean morning PEF||20.9|10.2|<0.001
72389280|NCT02571777|144286598|SUPERIORITY||LS Mean|28.5|STANDARD_ERROR_OF_MEAN|2.72|<|0.001|TWO_SIDED|95.0|23.2|33.8|||LMM|||Week 52 - Mean morning PEF||33.8|23.2|<0.001
72389281|NCT02571777|144286598|SUPERIORITY||LS Mean|17.5|STANDARD_ERROR_OF_MEAN|2.66|<|0.001|TWO_SIDED|95.0|12.3|22.8|||LMM|||Week 52 - Mean evening PEF||22.8|12.3|<0.001
72389282|NCT02571777|144286598|SUPERIORITY||LS Mean|29.5|STANDARD_ERROR_OF_MEAN|2.66|<|0.001|TWO_SIDED|95.0|24.2|34.7|||LMM|||Week 52 - Mean evening PEF||34.7|24.2|<0.001
72389283|NCT02571777|144286598|SUPERIORITY||LS Mean|15.0|STANDARD_ERROR_OF_MEAN|2.69|<|0.001|TWO_SIDED|95.0|9.7|20.2|||LMM|||Week 52 - Mean evening PEF||20.2|9.7|<0.001
72389284|NCT02571777|144286598|SUPERIORITY||LS Mean|25.8|STANDARD_ERROR_OF_MEAN|2.68|<|0.001|TWO_SIDED|95.0|20.5|31.0|||LMM|||Week 52 - Mean evening PEF||31.0|20.5|<0.001
72389285|NCT02571777|144286599|SUPERIORITY||LS Mean|0.2|STANDARD_ERROR_OF_MEAN|1.81||0.907|TWO_SIDED|95.0|-3.3|3.8|||LMM|||||3.8|-3.3|0.907
72389286|NCT02571777|144286599|SUPERIORITY||LS Mean|3.5|STANDARD_ERROR_OF_MEAN|1.81||0.055|TWO_SIDED|95.0|-0.1|7.0|||LMM|||||7.0|-0.1|0.055
72389287|NCT02571777|144286599|SUPERIORITY||LS Mean|0.0|STANDARD_ERROR_OF_MEAN|1.83||0.997|TWO_SIDED|95.0|-3.6|3.6|||LMM|||||3.6|-3.6|0.997
72389288|NCT02571777|144286599|SUPERIORITY||LS Mean|-0.9|STANDARD_ERROR_OF_MEAN|1.82||0.606|TWO_SIDED|95.0|-4.5|2.6|||LMM|||||2.6|-4.5|0.606
72389289|NCT02571777|144286600|SUPERIORITY||LS Mean|0.7|STANDARD_ERROR_OF_MEAN|1.78||0.712|TWO_SIDED|95.0|-2.8|4.2|||LMM|||||4.2|-2.8|0.712
72389290|NCT02571777|144286600|SUPERIORITY||LS Mean|3.7|STANDARD_ERROR_OF_MEAN|1.78||0.038|TWO_SIDED|95.0|0.2|7.2|||LMM|||||7.2|0.2|0.038
72389291|NCT02571777|144286600|SUPERIORITY||LS Mean|-0.1|STANDARD_ERROR_OF_MEAN|1.8||0.943|TWO_SIDED|95.0|-3.7|3.4|||LMM|||||3.4|-3.7|0.943
72389292|NCT02571777|144286600|SUPERIORITY||LS Mean|-0.9|STANDARD_ERROR_OF_MEAN|1.79||0.612|TWO_SIDED|95.0|-4.4|2.6|||LMM|||||2.6|-4.4|0.612
72389293|NCT02571777|144286601|SUPERIORITY||LS Mean|-0.4|STANDARD_ERROR_OF_MEAN|1.51||0.809|TWO_SIDED|95.0|-3.3|2.6|||LMM|||||2.6|-3.3|0.809
72389294|NCT02571777|144286601|SUPERIORITY||LS Mean|1.1|STANDARD_ERROR_OF_MEAN|1.5||0.467|TWO_SIDED|95.0|-1.9|4.0|||LMM|||||4.0|-1.9|0.467
72389295|NCT02571777|144286601|SUPERIORITY||LS Mean|1.5|STANDARD_ERROR_OF_MEAN|1.52||0.318|TWO_SIDED|95.0|-1.5|4.5|||LMM|||||4.5|-1.5|0.318
72389296|NCT02571777|144286601|SUPERIORITY||LS Mean|0.7|STANDARD_ERROR_OF_MEAN|1.51||0.64|TWO_SIDED|95.0|-2.3|3.7|||LMM|||||3.7|-2.3|0.640
72389297|NCT02571777|144286602|SUPERIORITY||LS Mean|-0.4|STANDARD_ERROR_OF_MEAN|1.83||0.814|TWO_SIDED|95.0|-4.0|3.2|||LMM|||||3.2|-4.0|0.814
72389298|NCT02571777|144286602|SUPERIORITY||LS Mean|3.8|STANDARD_ERROR_OF_MEAN|1.83||0.036|TWO_SIDED|95.0|0.2|7.4|||LMM|||||7.4|0.2|0.036
72389299|NCT02571777|144286602|SUPERIORITY||LS Mean|3.1|STANDARD_ERROR_OF_MEAN|1.84||0.098|TWO_SIDED|95.0|-0.6|6.7|||LMM|||||6.7|-0.6|0.098
72389300|NCT02571777|144286602|SUPERIORITY||LS Mean|2.9|STANDARD_ERROR_OF_MEAN|1.84||0.118|TWO_SIDED|95.0|-0.7|6.5|||LMM|||||6.5|-0.7|0.118
72389301|NCT02571777|144286603|SUPERIORITY||LS Mean|-0.8|STANDARD_ERROR_OF_MEAN|1.74||0.645|TWO_SIDED|95.0|-4.2|2.6|||LMM|||Week 26||2.6|-4.2|0.645
72389302|NCT02571777|144286603|SUPERIORITY||LS Mean|2.9|STANDARD_ERROR_OF_MEAN|1.73||0.095|TWO_SIDED|95.0|-0.5|6.3|||LMM|||Week 26||6.3|-0.5|0.095
72389303|NCT02571777|144286603|SUPERIORITY||LS Mean|1.3|STANDARD_ERROR_OF_MEAN|1.75||0.46|TWO_SIDED|95.0|-2.1|4.7|||LMM|||Week 26||4.7|-2.1|0.460
72389304|NCT02571777|144286603|SUPERIORITY||LS Mean|-0.1|STANDARD_ERROR_OF_MEAN|1.75||0.971|TWO_SIDED|95.0|-3.5|3.4|||LMM|||Week 26||3.4|-3.5|0.971
72389305|NCT02571777|144286603|SUPERIORITY||LS Mean|0.1|STANDARD_ERROR_OF_MEAN|1.78||0.963|TWO_SIDED|95.0|-3.4|3.6|||LMM|||Week 52||3.6|-3.4|0.963
72389306|NCT02571777|144286603|SUPERIORITY||LS Mean|3.2|STANDARD_ERROR_OF_MEAN|1.77||0.075|TWO_SIDED|95.0|-0.3|6.6|||LMM|||Week 52||6.6|-0.3|0.075
72389307|NCT02571777|144286603|SUPERIORITY||LS Mean|1.2|STANDARD_ERROR_OF_MEAN|1.79||0.517|TWO_SIDED|95.0|-2.3|4.7|||LMM|||Week 52||4.7|-2.3|0.517
72389308|NCT02571777|144286603|SUPERIORITY||LS Mean|0.1|STANDARD_ERROR_OF_MEAN|1.78||0.956|TWO_SIDED|95.0|-3.4|3.6|||LMM|||Week 52||3.6|-3.4|0.956
72389309|NCT02571777|144286604|SUPERIORITY||Odds Ratio (OR)|0.92||||0.535|TWO_SIDED|95.0|0.7|1.2|||Logistic regression model|||Week 26||1.20|0.70|0.535
72389310|NCT02571777|144286604|SUPERIORITY||Odds Ratio (OR)|1.21||||0.151|TWO_SIDED|95.0|0.93|1.57|||Logistic regression model|||Week 26||1.57|0.93|0.151
72389311|NCT02571777|144286604|SUPERIORITY||Odds Ratio (OR)|1.13||||0.38|TWO_SIDED|95.0|0.86|1.48|||Logistic regression model|||Week 26||1.48|0.86|0.380
72389312|NCT02571777|144286604|SUPERIORITY||Odds Ratio (OR)|1.2||||0.172|TWO_SIDED|95.0|0.92|1.57|||Logistic regression model|||Week 26||1.57|0.92|0.172
72389313|NCT02571777|144286604|SUPERIORITY||Odds Ratio (OR)|1.1||||0.51|TWO_SIDED|95.0|0.83|1.47|||Logistic regression model|||Week 52||1.47|0.83|0.510
72389314|NCT02571777|144286604|SUPERIORITY||Odds Ratio (OR)|1.41||||0.017|TWO_SIDED|95.0|1.06|1.86|||Logistic regression model|||Week 52||1.86|1.06|0.017
72389315|NCT02571777|144286604|SUPERIORITY||Odds Ratio (OR)|1.05||||0.744|TWO_SIDED|95.0|0.79|1.38|||Logistic regression model|||Week 52||1.38|0.79|0.744
72389316|NCT02571777|144286604|SUPERIORITY||Odds Ratio (OR)|0.99||||0.922|TWO_SIDED|95.0|0.75|1.29|||Logistic regression model|||Week 52||1.29|0.75|0.922
72389317|NCT02571777|144286605|SUPERIORITY||Hazard Ratio (HR)|0.66||||0.371|TWO_SIDED|95.0|0.27|1.63|||Regression, Cox|||||1.63|0.27|0.371
72389318|NCT02571777|144286605|SUPERIORITY||Hazard Ratio (HR)|1.0||||0.996|TWO_SIDED|95.0|0.37|2.66|||Regression, Cox|||||2.66|0.37|0.996
72389319|NCT02571777|144286605|SUPERIORITY||Hazard Ratio (HR)|1.89||||0.145|TWO_SIDED|95.0|0.8|4.47|||Regression, Cox|||||4.47|0.80|0.145
72389320|NCT02571777|144286605|SUPERIORITY||Hazard Ratio (HR)|1.88||||0.15|TWO_SIDED|95.0|0.8|4.43|||Regression, Cox|||||4.43|0.80|0.150
72389321|NCT02571777|144286606|SUPERIORITY||Hazard Ratio (HR)|0.94||||0.523|TWO_SIDED|95.0|0.77|1.15|||Regression, Cox|||Moderate or severe asthma exacerbation||1.15|0.77|0.523
72389322|NCT02571777|144286606|SUPERIORITY||Hazard Ratio (HR)|0.7|||<|0.001|TWO_SIDED|95.0|0.58|0.84|||Regression, Cox|||Moderate or severe asthma exacerbation||0.84|0.58|<0.001
72389323|NCT02571777|144286606|SUPERIORITY||Hazard Ratio (HR)|0.87||||0.164|TWO_SIDED|95.0|0.72|1.06|||Regression, Cox|||Moderate or severe asthma exacerbation||1.06|0.72|0.164
72389324|NCT02571777|144286606|SUPERIORITY||Hazard Ratio (HR)|0.76||||0.005|TWO_SIDED|95.0|0.63|0.92|||Regression, Cox|||Moderate or severe asthma exacerbation||0.92|0.63|0.005
72389325|NCT02571777|144286606|SUPERIORITY||Hazard Ratio (HR)|0.92||||0.476|TWO_SIDED|95.0|0.72|1.16|||Regression, Cox|||Severe asthma exacerbation||1.16|0.72|0.476
72389326|NCT02571777|144286606|SUPERIORITY||Hazard Ratio (HR)|0.68|||<|0.001|TWO_SIDED|95.0|0.54|0.85|||Regression, Cox|||Severe asthma exacerbation||0.85|0.54|<0.001
72389327|NCT02571777|144286606|SUPERIORITY||Hazard Ratio (HR)|0.88||||0.243|TWO_SIDED|95.0|0.7|1.09|||Regression, Cox|||Severe asthma exacerbation||1.09|0.70|0.243
72389328|NCT02571777|144286606|SUPERIORITY||Hazard Ratio (HR)|0.78||||0.027|TWO_SIDED|95.0|0.63|0.97|||Regression, Cox|||Severe asthma exacerbation||0.97|0.63|0.027
72389329|NCT02571777|144286606|SUPERIORITY||Hazard Ratio (HR)|0.94||||0.497|TWO_SIDED|95.0|0.79|1.12|||Regression, Cox|||All (mild, moderate, severe) asthma exacerbation||1.12|0.79|0.497
72389330|NCT02571777|144286606|SUPERIORITY||Hazard Ratio (HR)|0.71|||<|0.001|TWO_SIDED|95.0|0.6|0.84|||Regression, Cox|||All (mild, moderate, severe) asthma exacerbation||0.84|0.60|<0.001
72389331|NCT02571777|144286606|SUPERIORITY||Hazard Ratio (HR)|0.87||||0.126|TWO_SIDED|95.0|0.73|1.04|||Regression, Cox|||All (mild, moderate, severe) asthma exacerbation||1.04|0.73|0.126
72389332|NCT02571777|144286606|SUPERIORITY||Hazard Ratio (HR)|0.72|||<|0.001|TWO_SIDED|95.0|0.61|0.85|||Regression, Cox|||All (mild, moderate, severe) asthma exacerbation||0.85|0.61|<0.001
72389333|NCT02571777|144286607|SUPERIORITY||Rate ratio|0.85||||0.12|TWO_SIDED|95.0|0.68|1.04|||Generalized linear model|||Moderate or severe asthma exacerbation||1.04|0.68|0.120
72389334|NCT02571777|144286607|SUPERIORITY||Rate ratio|0.64|||<|0.001|TWO_SIDED|95.0|0.52|0.78|||Generalized linear model|||Moderate or severe asthma exacerbation||0.78|0.52|<0.001
72444906|NCT01566695|144404535|SUPERIORITY|HI-E|Rate Difference|10.9||||0.1467|TWO_SIDED|95.0|-2.0|23.7|||Stratified Mantel-Haenszel. Chi-squared|Stratified by average BL RBC tfx needs: ≤4 units versus \>4 units; BL platelet tfx status: dependent or independent and ECOG PS: 0 to 1 vs 2||||23.7|-2.0|0.1467
72444907|NCT01566695|144404535|SUPERIORITY|≥ 1.5 g/dL Hemoglobin Increase|Rate Diffrence|17.9||||0.0002|TWO_SIDED|95.0|8.8|26.9|||Stratified Mantel-Haenszel. Chi-squared|Stratified by average BL RBC tfx needs: ≤4 units versus \>4 units; BL platelet tfx status: dependent or independent and ECOG PS: 0 to 1 vs 2||||26.9|8.8|0.0002
72444908|NCT01566695|144404535|SUPERIORITY|RBC Transfusion Reduction|Rate Difference|10.9||||0.1431|TWO_SIDED|95.0|-1.9|23.6|||Stratified Mantel-Haenszel. Chi-squared|Stratified by average BL RBC tfx needs: ≤4 units versus \>4 units; BL platelet tfx status: dependent or independent and ECOG PS: 0 to 1 vs 2||||23.6|-1.9|0.1431
72444909|NCT01566695|144404536|SUPERIORITY||Rate Difference|17.0||||0.0007|TWO_SIDED|95.0|7.5|26.4|||Stratified Mantel-Haenszel. Chi-squared|Stratified by average BL RBC tfx needs: ≤4 units versus \>4 units; BL platelet tfx status: dependent or independent and ECOG PS: 0 to 1 vs 2||||26.4|7.5|0.0007
72444910|NCT01566695|144404539|OTHER||Hazard Ratio (HR)|1.08||||0.6257|TWO_SIDED|95.0|0.79|1.49|||Log Rank||||Cox proportional hazards model with stratifies factors|1.49|0.79|0.6257
72444911|NCT01566695|144404545|SUPERIORITY|||||||0.214|||||||t-test, 2 sided|The p-value was calculated based on a pooled 2-sample, 2-sided t-test for the difference in mean change from baseline between treatment groups.||||||0.214
72444912|NCT01566695|144404546|SUPERIORITY|||||||0.446|||||||t-test, 2 sided|The p-value was calculated based on a pooled 2-sample, 2-sided t-test for the difference in mean change from baseline between treatment groups.||||||0.446
72444913|NCT01566695|144404547|SUPERIORITY|||||||0.248|||||||t-test, 2 sided|The p-value was calculated based on a pooled 2-sample, 2-sided t-test for the difference in mean change from baseline between treatment groups.||||||0.248
72444914|NCT01566695|144404548|SUPERIORITY|||||||0.058|||||||t-test, 2 sided|The p-value was calculated based on a pooled 2-sample, 2-sided t-test for the difference in mean change from baseline between treatment groups.||||||0.058
72444915|NCT01566695|144404549|SUPERIORITY|||||||0.13|||||||t-test, 2 sided|The p-value was calculated based on a pooled 2-sample, 2-sided t-test for the difference in mean change from baseline between treatment groups.||||||0.130
72444916|NCT01566695|144404550|SUPERIORITY|||||||0.123|||||||t-test, 2 sided|The p-value was calculated based on a pooled 2-sample, 2-sided t-test for the difference in mean change from baseline between treatment groups.||||||0.123
72444917|NCT01566695|144404551|SUPERIORITY|||||||0.069|||||||t-test, 2 sided|The p-value was calculated based on a pooled 2-sample, 2-sided t-test for the difference in mean change from baseline between treatment groups.||||||0.069
72497359|NCT03183128|144524648|SUPERIORITY||Hazard Ratio (HR)|0.46|||<|0.001|TWO_SIDED|95.0|0.3|0.73||P-value presented is for the hypothesis test: H0: RR ≥1.0.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel estimate is stratified by age (\<65 years, ≥65 years) and prior antibiotic regimen (vancomycin, fidaxomicin).|RR defined as the recurrence rates of SER-109 divided by Placebo. Cochran-Mantel-Haenszel estimate of RR, stratified by age group (\<65 years, ≥65 years) and prior antibiotic regimen for the qualifying episode (vancomycin, fidaxomicin), is reported.|CDI recurrence rates at Week 24||0.73|0.30|<0.001
72619241|NCT06399471|144769077|OTHER|One-way Repeated Measures ANOVA with sphericity correction (Huynh-Feldt) applied if necessary.||||||0.943|||||||ANOVA|||An ANOVA was used to compare the reported falls when for when the Power Knee, C-Leg 4.0, and the Rheo were used.||||0.943
72444918|NCT01566695|144404552|SUPERIORITY|||||||0.078|||||||t-test, 2 sided|The p-value was calculated based on a pooled 2-sample, 2-sided t-test for the difference in mean change from baseline between treatment groups.||||||0.078
72444919|NCT01566695|144404553|SUPERIORITY|||||||0.073|||||||t-test, 2 sided|The p-value was calculated based on a pooled 2-sample, 2-sided t-test for the difference in mean change from baseline between treatment groups.||||||0.073
72444920|NCT01566695|144404554|SUPERIORITY||Common Odds Raatio|0.77||||0.56|TWO_SIDED|95.0|0.54|1.3|||Cochran-Mantel-Haenszel|The p-value was calculated based on the CMH tests for comparing the odds of experiencing CMI between CC-486 versus placebo.|||The common odds ratio and the 95% confidence interval (CI) were calculated using CMH tests, stratified by randomization stratification factors, to compare the odds of experiencing clinically meaningful improvement between CC-486 and placebo.|1.30|0.54|0.560
72444921|NCT01566695|144404555|SUPERIORITY||Common Odds Raatio|0.72||||0.48|TWO_SIDED|95.0|0.29|1.78|||Cochran-Mantel-Haenszel|The p-value was calculated based on the CMH tests for comparing the odds of experiencing CMI between CC-486 versus placebo.|||The common odds ratio and the 95% confidence interval (CI) were calculated using CMH tests, stratified by randomization stratification factors, to compare the odds of experiencing clinically meaningful improvement between CC-486 and placebo.|1.78|0.29|0.480
72444922|NCT01566695|144404556|SUPERIORITY||Common Odds Ratio|1.67||||0.197|TWO_SIDED|95.0|0.76|3.65|||Cochran-Mantel-Haenszel|The p-value was calculated based on the CMH tests for comparing the odds of experiencing CMI between CC-486 versus placebo.|||The common odds ratio and the 95% confidence interval (CI) were calculated using CMH tests, stratified by randomization stratification factors, to compare the odds of experiencing clinically meaningful improvement between CC-486 and placebo.|3.65|0.76|0.197
72444923|NCT01566695|144404557|SUPERIORITY||Common Odds Ratio|2.14||||0.121|TWO_SIDED|95.0|0.82|5.57|||Cochran-Mantel-Haenszel|The p-value was calculated based on the CMH tests for comparing the odds of experiencing CMI between CC-486 versus placebo.|||The common odds ratio and the 95% confidence interval (CI) were calculated using CMH tests, stratified by randomization stratification factors, to compare the odds of experiencing clinically meaningful improvement between CC-486 and placebo.|5.57|0.82|0.121
72444924|NCT01566695|144404558|SUPERIORITY||Common Odds Ratio|2.0||||0.075|TWO_SIDED|95.0|0.93|4.3|||Cochran-Mantel-Haenszel|The p-value was calculated based on the CMH tests for comparing the odds of experiencing CMI between CC-486 versus placebo.|||The common odds ratio and the 95% confidence interval (CI) were calculated using CMH tests, stratified by randomization stratification factors, to compare the odds of experiencing clinically meaningful improvement between CC-486 and placebo.|4.30|0.93|0.075
72497360|NCT01171612|144524672|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.086||||0.479|TWO_SIDED|95.0|0.513|2.299|||Chi-squared|||Reference group were patients who maintained antiplatelet drugs (aspirin and/or clopidogrel) during the 4 days before surgery||2.299|0.513|0.479
72497361|NCT01171612|144524672|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.638||||0.479|TWO_SIDED|95.0|0.733|3.662|||Chi-squared|||||3.662|0.733|0.479
72497362|NCT04666038|144524699|SUPERIORITY||Hazard Ratio (HR)|0.536||||0.0002|TWO_SIDED|95.0|0.385|0.746||The 2-sided nominal p-value was calculated based on a stratified log-rank test.|Log Rank||The Hazard Ratio (HR) \& 95% confidence interval (CI) were estimated from a stratified Cox proportional hazards model.|||0.746|0.385|0.0002
72497363|NCT04666038|144524700|SUPERIORITY||Hazard Ratio (HR)|0.475|||<|0.0001|TWO_SIDED|95.0|0.338|0.669||The 2-sided nominal p-value was calculated based on a stratified log-rank test|Log Rank||The HR and 95% CI were estimated from a stratified Cox proportional hazards model.|||0.669|0.338|<0.0001
72497364|NCT04666038|144524701|SUPERIORITY||Hazard Ratio (HR)|1.09||||0.7202|TWO_SIDED|95.0|0.679|1.749||The 2-sided p-value was calculated based on a stratified log-rank test.|Log Rank||The HR and 95% CI were estimated from a stratified Cox proportional hazards model.|||1.749|0.679|0.7202
72560528|NCT00288704|144651470|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|Comparison of p-value was a parametric ANCOVA main effects model with part A Baseline variable as covariate and treatment.||"Subjects received rilonacept 160 mg for 9 weeks (weeks 6-15), and then were re-randomized 1:1 into either Placebo or rilonacept 160 mg. The endpoint for the period was 9 weeks later (week 24).~The sample size calculations at the time suggested 50 subjects would be enrolled at baseline. The Full Analysis Set (FAS) was used. The FAS included subjects who received at least one dose of rilonacept. Last observation carried forward was used."||||<0.001
72560529|NCT00288704|144651471|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|Comparison of p-value was a parametric ANCOVA main effects model with part A Baseline variable as covariate and treatment.||The sample size calculations at the time suggested 50 subjects would be enrolled at baseline. The Full Analysis Set (FAS) was used. The FAS included subjects who received at least one dose of rilonacept. Last observation carried forward was used.||||<.0001
72619242|NCT06399471|144769078|OTHER|One-way Repeated Measures ANOVA with sphericity correction (Huynh-Feldt) applied if necessary.||||||0.535|||||||ANOVA|||An ANOVA was used to compare the Physiological cost index for when the Power Knee, the C-Leg 4.0, and the Rheo were used.||||0.535
72389335|NCT02571777|144286607|SUPERIORITY||Rate ratio|0.87||||0.17|TWO_SIDED|95.0|0.71|1.06|||Generalized linear modeñ|||Moderate or severe asthma exacerbation||1.06|0.71|0.170
72389336|NCT02571777|144286607|SUPERIORITY||Rate ratio|0.81||||0.041|TWO_SIDED|95.0|0.66|0.99|||Generalized linear model|||Moderate or severe asthma exacerbation||0.99|0.66|0.041
72389337|NCT02571777|144286607|SUPERIORITY||Rate ratio|0.78||||0.05|TWO_SIDED|95.0|0.61|1.0|||Generalized linear model|||Severe asthma exacerbation||1.00|0.61|0.050
72389338|NCT02571777|144286607|SUPERIORITY||Rate ratio|0.58|||<|0.001|TWO_SIDED|95.0|0.45|0.73|||Generalized linear model|||Severe asthma exacerbation||0.73|0.45|<0.001
72389339|NCT02571777|144286607|SUPERIORITY||Rate ratio|0.93||||0.531|TWO_SIDED|95.0|0.74|1.17|||Generalized linear model|||Severe asthma exacerbation||1.17|0.74|0.531
72389340|NCT02571777|144286607|SUPERIORITY||Rate ratio|0.84||||0.117|TWO_SIDED|95.0|0.67|1.05|||Linear generalized model|||Severe asthma exacerbation||1.05|0.67|0.117
72389341|NCT02571777|144286607|SUPERIORITY||Rate ratio|0.79||||0.016|TWO_SIDED|95.0|0.66|0.96|||Generalized linear model|||All (mild, moderate, severe) asthma exacerbation||0.96|0.66|0.016
72389342|NCT02571777|144286607|SUPERIORITY||Rate ratio|0.6|||<|0.001|TWO_SIDED|95.0|0.5|0.72|||Generalized linear model|||All (mild, moderate, severe) asthma exacerbation||0.72|0.50|<0.001
72389343|NCT02571777|144286607|SUPERIORITY||Rate ratio|0.87||||0.161|TWO_SIDED|95.0|0.72|1.06|||Generalized linear model|||All (mild, moderate, severe) asthma exacerbation||1.06|0.72|0.161
72389344|NCT02571777|144286607|SUPERIORITY||Rate ratio|0.7|||<|0.001|TWO_SIDED|95.0|0.58|0.84|||Generalized linear model|||All (mild, moderate, severe) asthma exacerbation||0.84|0.58|<0.001
72389345|NCT02571777|144286608|SUPERIORITY|||||||0.183|||||||van Elteren test|||Moderate or severe asthma exacerbation||||0.183
72389346|NCT02571777|144286608|SUPERIORITY||||||<|0.001|||||||van Elteren test|||Moderate or severe asthma exacerbation||||<0.001
72389347|NCT02571777|144286608|SUPERIORITY|||||||0.155|||||||van Elteren test|||Moderate or severe asthma exacerbation||||0.155
72389348|NCT02571777|144286608|SUPERIORITY|||||||0.007|||||||van Elteren test|||Moderate or severe asthma exacerbation||||0.007
72389349|NCT02571777|144286608|SUPERIORITY|||||||0.172|||||||van Elteren test|||Severe asthma exacerbation||||0.172
72389350|NCT02571777|144286608|SUPERIORITY||||||<|0.001|||||||van Elteren test|||Severe asthma exacerbation||||<0.001
72389351|NCT02571777|144286608|SUPERIORITY|||||||0.241|||||||van Elteren test|||Severe asthma exacerbation||||0.241
72389352|NCT02571777|144286608|SUPERIORITY|||||||0.033|||||||van Elteren test|||Severe asthma exacerbation||||0.033
72389353|NCT02571777|144286608|SUPERIORITY|||||||0.095|||||||van Elteren test|||All (mild, moderate, severe) asthma exacerbation||||0.095
72389354|NCT02571777|144286608|SUPERIORITY||||||<|0.001|||||||van Elteren test|||All (mild, moderate, severe) asthma exacerbation||||<0.001
72389355|NCT02571777|144286608|SUPERIORITY|||||||0.09|||||||van Elteren test|||All (mild, moderate, severe) asthma exacerbation||||0.090
72389356|NCT02571777|144286608|SUPERIORITY||||||<|0.001|||||||van Elteren test|||All (mild, moderate, severe) asthma exacerbation||||<0.001
72389357|NCT02571777|144286610|SUPERIORITY||Hazard Ratio (HR)|0.49||||0.314|TWO_SIDED|95.0|0.12|1.96|||Regression, Cox|||||1.96|0.12|0.314
72389358|NCT02571777|144286610|SUPERIORITY||Hazard Ratio (HR)|0.28||||0.055|TWO_SIDED|95.0|0.08|1.03|||Regression, Cox|||||1.03|0.08|0.055
72389359|NCT02571777|144286610|SUPERIORITY||Hazard Ratio (HR)|0.62||||0.306|TWO_SIDED|95.0|0.25|1.54|||Regression, Cox|||||1.54|0.25|0.306
72389360|NCT02571777|144286610|SUPERIORITY||Hazard Ratio (HR)|0.76||||0.566|TWO_SIDED|95.0|0.3|1.94|||Regression, Cox|||||1.94|0.30|0.566
72389361|NCT02571777|144286612|SUPERIORITY||LS Mean|-0.8|STANDARD_ERROR_OF_MEAN|1.74||0.645|TWO_SIDED|95.0|-4.2|2.6|||LMM|||Week 26||2.6|-4.2|0.645
72389362|NCT02571777|144286612|SUPERIORITY||LS Mean|2.9|STANDARD_ERROR_OF_MEAN|1.73||0.095|TWO_SIDED|95.0|-0.5|6.3|||LMM|||Week 26||6.3|-0.5|0.095
72389363|NCT02571777|144286612|SUPERIORITY||LMM|1.3|STANDARD_ERROR_OF_MEAN|1.75||0.46|TWO_SIDED|95.0|-2.1|4.7|||LMM|||Week 26||4.7|-2.1|0.460
72389364|NCT02571777|144286612|SUPERIORITY||LS Mean|-0.1|STANDARD_ERROR_OF_MEAN|1.75||0.971|TWO_SIDED|95.0|-3.5|3.4|||LMM|||Week 26||3.4|-3.5|0.971
72497365|NCT04666038|144524702|SUPERIORITY||Hazard Ratio (HR)|0.365|||<|0.0001|TWO_SIDED|95.0|0.254|0.524||The 2-sided nominal p-value was calculated based on a stratified log-rank test.|Log Rank||The HR and 95% CI were estimated from a stratified Cox proportional hazards model.|||0.524|0.254|<0.0001
72497366|NCT04666038|144524703|SUPERIORITY||Hazard Ratio (HR)|0.387|||<|0.0001|TWO_SIDED|95.0|0.28|0.534||The 2-sided nominal p-value was calculated based on a stratified log-rank test.|Log Rank||The HR and 95% CI were estimated from a stratified Cox proportional hazards model.|||0.534|0.280|<0.0001
72389365|NCT02571777|144286612|SUPERIORITY||LMM|0.1|STANDARD_ERROR_OF_MEAN|1.78||0.963|TWO_SIDED|95.0|-3.4|3.6|||LMM|||Week 52||3.6|-3.4|0.963
72389366|NCT02571777|144286612|SUPERIORITY||LS Mean|3.2|STANDARD_ERROR_OF_MEAN|1.77||0.075|TWO_SIDED|95.0|-0.3|6.6|||LMM|||Week 52||6.6|-0.3|0.075
72389367|NCT02571777|144286612|SUPERIORITY||LS Mean|1.2|STANDARD_ERROR_OF_MEAN|1.79||0.517|TWO_SIDED|95.0|-2.3|4.7|||LMM|||Week 52||4.7|-2.3|0.517
72389368|NCT02571777|144286612|SUPERIORITY||LS Mean|0.1|STANDARD_ERROR_OF_MEAN|1.78||0.956|TWO_SIDED|95.0|-3.4|3.6|||LMM|||Week 52||3.6|-3.4|0.956
72389369|NCT02571777|144286613|SUPERIORITY||LS Mean|0.02|STANDARD_ERROR_OF_MEAN|0.0502||0.69|TWO_SIDED|95.0|-0.078|0.118|||MMRM|||||0.118|-0.078|0.690
72389370|NCT02571777|144286613|SUPERIORITY||LS Mean|0.06|STANDARD_ERROR_OF_MEAN|0.0502||0.232|TWO_SIDED|95.0|-0.038|0.159|||MMRM|||||0.159|-0.038|0.232
72389371|NCT02571777|144286613|SUPERIORITY||LS Mean|-0.054|STANDARD_ERROR_OF_MEAN|0.0506||0.285|TWO_SIDED|95.0|-0.153|0.045|||MMRM|||||0.045|-0.153|0.285
72389372|NCT02571777|144286613|SUPERIORITY||LS Mean|-0.05|STANDARD_ERROR_OF_MEAN|0.0505||0.319|TWO_SIDED|95.0|-0.15|0.049|||MMRM|||||0.049|-0.150|0.319
72389373|NCT02571777|144286614|SUPERIORITY||LS Mean|0.068|STANDARD_ERROR_OF_MEAN|0.0166|<|0.001|TWO_SIDED|95.0|0.036|0.101|||MMRM|||Week 4||0.101|0.036|<0.001
72389374|NCT02571777|144286614|SUPERIORITY||LS Mean|0.145|STANDARD_ERROR_OF_MEAN|0.0165|<|0.001|TWO_SIDED|95.0|0.113|0.177|||MMRM|||Week 4||0.177|0.113|<0.001
72389375|NCT02571777|144286614|SUPERIORITY||LS Mean|0.033|STANDARD_ERROR_OF_MEAN|0.0167||0.049|TWO_SIDED|95.0|0.0|0.066|||MMRM|||Week 4||0.066|0.000|0.049
72389376|NCT02571777|144286614|SUPERIORITY||LS Mean|0.096|STANDARD_ERROR_OF_MEAN|0.0166|<|0.001|TWO_SIDED|95.0|0.064|0.129|||MMRM|||Week 4||0.129|0.064|<0.001
72389377|NCT02571777|144286614|SUPERIORITY||LS Mean|0.058|STANDARD_ERROR_OF_MEAN|0.0184||0.002|TWO_SIDED|95.0|0.022|0.094|||MMRM|||Week 12||0.094|0.022|0.002
72389378|NCT02571777|144286614|SUPERIORITY||LS Mean|0.117|STANDARD_ERROR_OF_MEAN|0.0183|<|0.001|TWO_SIDED|95.0|0.081|0.153|||MMRM|||Week 12||0.153|0.081|<0.001
72389379|NCT02571777|144286614|SUPERIORITY||LS Mean|0.05|STANDARD_ERROR_OF_MEAN|0.0185||0.007|TWO_SIDED|95.0|0.013|0.086|||MMRM|||Week 12||0.086|0.013|0.007
72389380|NCT02571777|144286614|SUPERIORITY||MMRM|0.087|STANDARD_ERROR_OF_MEAN|0.0184|<|0.001|TWO_SIDED|95.0|0.051|0.123|||MMRM|||Week 12||0.123|0.051|<0.001
72389381|NCT00801632|144286616|SUPERIORITY_OR_OTHER||Percentage of Participants|60.0|||||TWO_SIDED|95.0|14.7|94.7|||||Clopper-Pearson used to derive confidence interval|||94.7|14.7|
72389382|NCT00801632|144286618|SUPERIORITY_OR_OTHER|||||||0.215|TWO_SIDED|||||P-value based on a paired t-test comparing baseline creatinine level with the level at study completion/participant termination.|t-test, 2 sided|The test describes whether the average of the difference is different from zero.||||||0.215
72389383|NCT02229383|144286631|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.74|STANDARD_ERROR_OF_MEAN|0.101|<|0.001|TWO_SIDED|95.0|-0.94|-0.54|||Mixed Models Analysis|Treatment, region, baseline HbA1c (\< or ≥ 9.0%), baseline SU-use, week, treatment by week interaction as fixed factors; baseline value as covariate.||||-0.54|-0.94|<0.001
72389384|NCT02229383|144286632|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.52|STANDARD_ERROR_OF_MEAN|0.341|<|0.001|TWO_SIDED|95.0|-2.19|-0.85|||Mixed Models Analysis|Treatment, region, baseline HbA1c (\< or ≥ 9.0%), baseline SU-use, week, treatment by week interaction as fixed factors; baseline value as covariate.||||-0.85|-2.19|<0.001
72389385|NCT02229383|144286633|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-27.76|STANDARD_ERROR_OF_MEAN|5.754|<|0.001|TWO_SIDED|95.0|-39.07|-16.45|||ANCOVA|Treatment, region, baseline HbA1c (\< or ≥ 9.0%), baseline SU-use (yes vs. no) as fixed factors; baseline value as covariate.||||-16.45|-39.07|<0.001
72389386|NCT02229383|144286634|SUPERIORITY_OR_OTHER||Difference in percentages|25.6|||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by baseline HbA1c (\<9.0% or ≥9.0%) and baseline SU-use (yes vs. no).||||||<0.001
72389387|NCT02229383|144286635|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.9|STANDARD_ERROR_OF_MEAN|1.08||0.074|TWO_SIDED|95.0|-4.1|0.2|||Mixed Models Analysis|Treatment, region, baseline HbA1c (\< or ≥ 9.0%), baseline SU-use, week, treatment by week interaction as fixed factors; baseline value as covariate.||||0.2|-4.1|0.074
72389388|NCT02229383|144286636|SUPERIORITY_OR_OTHER||Difference in percentages|20.0|||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by baseline HbA1c (\<9.0% or ≥9.0%) and baseline SU-use (yes vs. no).||||||<0.001
72389389|NCT02229383|144286637|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.8|STANDARD_ERROR_OF_MEAN|1.13||0.11|TWO_SIDED|95.0|-4.0|0.4|||Mixed Models Analysis|Treatment, region, baseline HbA1c (\< or ≥ 9.0%), baseline SU-use, week, treatment by week interaction as fixed factors; baseline value as covariate.||||0.4|-4.0|0.110
72389390|NCT00191139|144286677|SUPERIORITY_OR_OTHER||survival rate|40.6||||||95.0|23.8|56.8|||normal approximation|Count the number of surviving participants at each time interval to get survival rates.||||56.8|23.8|
72389391|NCT00191139|144286677|SUPERIORITY_OR_OTHER||survival rate|55.7||||||95.0|36.8|70.9|||normal approximation|Count the number of surviving participants at each time interval to get survival rates.||||70.9|36.8|
72389392|NCT00191139|144286678|SUPERIORITY_OR_OTHER||Response Rate|75.0||||||95.0|56.6|88.5|||normal approximation|||||88.5|56.6|
72389393|NCT00191139|144286678|SUPERIORITY_OR_OTHER||Response rate|84.4||||||95.0|67.2|94.7|||Normal approximation|||||94.7|67.2|
72389394|NCT00191139|144286679|SUPERIORITY_OR_OTHER|||||||0.08||95.0|||||Log Rank|||||||0.08
72389395|NCT00191139|144286680|SUPERIORITY_OR_OTHER|||||||0.38||95.0|||||Log Rank|||||||0.38
72497367|NCT03400800|144524707|SUPERIORITY||Mean Difference (Final Values)|-53.5|||<|0.0001|TWO_SIDED|95.0|-56.66|-50.35||The a priori threshold for statistical significance was \<0.05|ANCOVA||Represents the least squares means difference from Placebo|||-50.35|-56.66|<0.0001
72497368|NCT03400800|144524708|SUPERIORITY||Mean Difference (Final Values)|-49.17|||<|0.0001|TWO_SIDED|95.0|-51.57|-46.77||The a priori threshold for statistical significance was \<0.05|ANCOVA||Represents the least squares means difference from Placebo|||-46.77|-51.57|<0.0001
72497369|NCT03400800|144524709|SUPERIORITY||Median Difference (Final Values)|-51.87|||<|0.0001|TWO_SIDED|95.0|-55.01|-48.72||The a priori threshold for statistical significance was \<0.05|ANCOVA||Represents the least squares means difference from Placebo|||-48.72|-55.01|<.0001
72497370|NCT03400800|144524710|SUPERIORITY||Mean Difference (Final Values)|-48.94|||<|0.0001|TWO_SIDED|95.0|-51.39|-46.48||The a priori threshold for statistical significance was \<0.05|ANCOVA||Represents the least squares means difference from Placebo|||-46.48|-51.39|<0.0001
72497371|NCT03400800|144524711|SUPERIORITY||Mean Difference (Final Values)|-79.27|||<|0.0001|TWO_SIDED|95.0|-81.97|-76.57||The a priori threshold for statistical significance was \<0.05|ANCOVA||Represents the least squares means difference from Placebo|||-76.57|-81.97|<0.0001
72497372|NCT03400800|144524712|SUPERIORITY||Mean Difference (Final Values)|-29.79|||<|0.0001|TWO_SIDED|95.0|-31.78|-27.81||The a priori threshold for statistical significance was \<0.05|ANCOVA||Represents the least squares means difference from Placebo|||-27.81|-31.78|<0.0001
72497373|NCT03400800|144524713|SUPERIORITY||Mean Difference (Final Values)|-38.94|||<|0.0001|TWO_SIDED|95.0|-41.21|-36.67||The a priori threshold for statistical significance was \<0.05|ANCOVA||Represents the least squares means difference from Placebo|||-36.67|-41.21|<0.0001
72497374|NCT03400800|144524714|SUPERIORITY||Mean Difference (Final Values)|-43.32|||<|0.0001|TWO_SIDED|95.0|-46.04|-40.6||The a priori threshold for statistical significance was \<0.05|ANCOVA||Represents the least squares means difference from Placebo|||-40.60|-46.04|<0.0001
72497375|NCT03094195|144524744|SUPERIORITY||least squares mean|-0.2|STANDARD_ERROR_OF_MEAN|0.56||0.689|TWO_SIDED|95.0|-1.3|0.9|||ANCOVA|Multiplicity adjustment for the pairwise comparisons has been performed using the Hochberg procedure. Adjusted p-value 0.689||||0.9|-1.3|0.689
72497376|NCT03094195|144524744|SUPERIORITY||LS Mean|-0.5|STANDARD_ERROR_OF_MEAN|0.54||0.35|TWO_SIDED|95.0|-1.6|0.6|||ANCOVA|Multiplicity adjustment for the pairwise comparisons has been performed using the Hochberg procedure. Adjusted p-value 0.689||||0.6|-1.6|0.350
72560530|NCT00288704|144651472|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|Comparison P-Value was a parametric ANCOVA main effects model with Part A Baseline variable as covariate and treatment.||The sample size calculations at the time suggested 50 subjects would be enrolled at baseline. The Full Analysis Set (FAS) was used. The FAS included subjects who received at least one dose of rilonacept. Last observation carried forward was used.||||<0.0001
72560531|NCT00288704|144651473|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|Comparison p-value is a parametric ANCOVA main effects model with Part A Baseline variable as covariate and treatment.||The sample size calculations at the time suggested 50 subjects would be enrolled at baseline. The Full Analysis Set (FAS) was used. The FAS included subjects who received at least one dose of rilonacept. Last observation carried forward was used.||||<.0001
72560532|NCT00288704|144651474|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|Comparison p-value was a parametric ANCOVA main effects model with Part A Baseline variable as covariate and treatment.||"Please note that the changes are medians (not means).~The sample size calculations at the time suggested 50 subjects would be enrolled at baseline. The Full Analysis Set (FAS) was used. The FAS included subjects who received at least one dose of rilonacept. Last observation carried forward was used."||||<0.0001
72560533|NCT00288704|144651475|SUPERIORITY_OR_OTHER||||||<|0.01||95.0|||||ANCOVA|Comparison p-value was a parametric ANCOVA main effects model with Part A Baseline variable as covariate and treatment.||"Please note that the changes are medians (not means).~The sample size calculations at the time suggested 50 subjects would be enrolled at baseline. The Full Analysis Set (FAS) was used. The FAS included subjects who received at least one dose of rilonacept. Last observation carried forward was used."||||<0.01
72619243|NCT06399471|144769079|OTHER|One-way Repeated Measures ANOVA with sphericity correction (Huynh-Feldt) applied if necessary.||||||0.229|||||||ANOVA|||An ANOVA was used to compare the Stair Ascent Speed for the Power Knee, C-Leg 4.0, and the Rheo when used.||||0.229
72389396|NCT03846804|144286684|OTHER|||||||0.36|||||||Wilcoxon (Mann-Whitney)|||||||0.36
72389397|NCT00345839|144286697|SUPERIORITY_OR_OTHER_LEGACY|||||||0.112||||||p-value\<0.044 considered significant|Log Rank|Stratified by history of diabetes and country. 2-sided test.||||||0.112
72389398|NCT00345839|144286697|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.93|||||TWO_SIDED|95.0|0.85|1.02|||Regression, Cox|Stratified by history of diabetes and country.|HR is cinacalcet vs placebo.|||1.02|0.85|
72389399|NCT00345839|144286698|SUPERIORITY_OR_OTHER_LEGACY|||||||0.249||||||No adjustments for multiple comparisons were made for the components of the primary composite endpoint since the purpose of these analyses is to show how each component contributes to the results of the composite.|Log Rank|Stratified by history of diabetes and country. 2-sided test.||||||0.249
72497377|NCT03094195|144524748|SUPERIORITY||Odds Ratio (OR)|0.9||||0.908|TWO_SIDED|95.0|0.3|3.2|||Regression, Logistic|||||3.2|0.3|0.908
72389400|NCT00345839|144286698|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.94|||||TWO_SIDED|95.0|0.85|1.04|||Regression, Cox|Stratified by history of diabetes and country.|HR is cinacalcet vs placebo.|||1.04|0.85|
72389401|NCT00345839|144286699|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8||||||No adjustments for multiple comparisons were made for the components of the primary composite endpoint since the purpose of these analyses is to show how each component contributes to the results of the composite.|Log Rank|Stratified by history of diabetes and country. 2-sided test.||||||0.800
72389402|NCT00345839|144286699|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.97|||||TWO_SIDED|95.0|0.79|1.19|||Regression, Cox|Stratified by history of diabetes and country.|HR is cinacalcet vs placebo.|||1.19|0.79|
72497378|NCT03094195|144524748|SUPERIORITY||Odds Ratio (OR)|1.4||||0.609|TWO_SIDED|95.0|0.4|4.5|||Regression, Logistic|||||4.5|0.4|0.609
72497379|NCT03094195|144524749|SUPERIORITY||Odds Ratio (OR)|0.9||||0.8|TWO_SIDED|95.0|0.3|3.2|||Regression, Logistic|||||3.2|0.3|0.800
72497380|NCT03094195|144524749|SUPERIORITY||Odds Ratio (OR)|1.4||||0.653|TWO_SIDED|95.0|0.4|4.5|||Regression, Logistic|||||4.5|0.4|0.653
72497381|NCT03094195|144524751|SUPERIORITY||LS mean difference|0.6|STANDARD_ERROR_OF_MEAN|0.49||0.225|TWO_SIDED|95.0|-0.4|1.6|||ANCOVA|||||1.6|-0.4|0.225
72560534|NCT00288704|144651476|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Fisher Exact|||The sample size calculations at the time suggested 50 subjects would be enrolled at baseline. The Full Analysis Set (FAS) was used. The FAS included subjects who received at least one dose of rilonacept. Last observation carried forward was used.||||<0.0001
72619244|NCT06399471|144769080|OTHER|One-way Repeated Measures ANOVA with sphericity correction (Huynh-Feldt) applied if necessary.||||||0.528|||||||ANOVA|||An ANOVA was used to compare the Stair Descent Speed for the Power Knee, C-Leg 4.0, and the Rheo when used.||||0.528
72444925|NCT01566695|144404559|SUPERIORITY||Common Odds Ratio|1.58||||0.222|TWO_SIDED|95.0|0.76|3.29|||Cochran-Mantel-Haenszel|The p-value was calculated based on the CMH tests for comparing the odds of experiencing CMI between CC-486 versus placebo.|||The common odds ratio and the 95% confidence interval (CI) were calculated using CMH tests, stratified by randomization stratification factors, to compare the odds of experiencing clinically meaningful improvement between CC-486 and placebo.|3.29|0.76|0.222
72444926|NCT01566695|144404560|SUPERIORITY||Common Odds Ratio|1.65||||0.249|TWO_SIDED|95.0|0.71|3.83|||Cochran-Mantel-Haenszel|The p-value was calculated based on the CMH tests for comparing the odds of experiencing CMI between CC-486 versus placebo.|||The common odds ratio and the 95% confidence interval (CI) were calculated using CMH tests, stratified by randomization stratification factors, to compare the odds of experiencing clinically meaningful improvement between CC-486 and placebo.|3.83|0.71|0.249
72444927|NCT01566695|144404561|SUPERIORITY||Common Odds Ratio|2.03||||0.082|TWO_SIDED|95.0|0.92|4.48|||Cochran-Mantel-Haenszel|The p-value was calculated based on the CMH tests for comparing the odds of experiencing CMI between CC-486 versus placebo.|||The common odds ratio and the 95% confidence interval (CI) were calculated using CMH tests, stratified by randomization stratification factors, to compare the odds of experiencing clinically meaningful improvement between CC-486 and placebo.|4.48|0.92|0.082
72444928|NCT01566695|144404562|SUPERIORITY||Common Odds Ratio|1.86||||0.153|TWO_SIDED|95.0|0.79|4.34|||Cochran-Mantel-Haenszel|The p-value was calculated based on the CMH tests for comparing the odds of experiencing CMI between CC-486 versus placebo.|||The common odds ratio and the 95% confidence interval (CI) were calculated using CMH tests, stratified by randomization stratification factors, to compare the odds of experiencing clinically meaningful improvement between CC-486 and placebo.|4.34|0.79|0.153
72560535|NCT00288704|144651477|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Fisher Exact|||The sample size calculations at the time suggested 50 subjects would be enrolled at baseline. The Full Analysis Set (FAS) was used. The FAS included subjects who received at least one dose of rilonacept. Last observation carried forward was used.||||<0.0001
72560536|NCT00288704|144651478|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Fisher Exact|||The sample size calculations at the time suggested 50 subjects would be enrolled at baseline. The Full Analysis Set (FAS) was used. The FAS included subjects who received at least one dose of rilonacept. Last observation carried forward was used.||||<0.0001
72560537|NCT01579006|144651499|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Wilcoxon Signed Rank Test|||||||<0.0001
72560538|NCT01579006|144651500|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Wilcoxon Signed Rank Test|||||||<0.0001
72560539|NCT01579006|144651501|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Wilcoxon Signed Rank Test|||||||<0.0001
72560540|NCT01579006|144651503|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Wilcoxon Signed Rank Test|||||||<0.0001
72560541|NCT01579006|144651504|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Wilcoxon Signed Rank Test|||||||<0.0001
72619245|NCT06399471|144769081|OTHER|One-way Repeated Measures ANOVA with sphericity correction (Huynh-Feldt) applied if necessary.||||||0.144|||||||ANOVA|||An ANOVA was used to compare the Ramp Ascent Speed between the Power Knee and the C-Leg 4.0.||||0.144
72560542|NCT01579006|144651510|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Wilcoxon Signed Rank Test|||||||<0.0001
72560543|NCT01579006|144651511|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Wilcoxon Signed Rank Test|||||||<0.0001
72619246|NCT06399471|144769081|OTHER|One-way Repeated Measures ANOVA with sphericity correction (Huynh-Feldt) applied if necessary.||||||0.024|||||||ANOVA|||An ANOVA was used to compare the Ramp Ascent Speed between the Power Knee and the Rheo.||||0.024
72619247|NCT06399471|144769081|OTHER|One-way Repeated Measures ANOVA with sphericity correction (Huynh-Feldt) applied if necessary.||||||0.949|||||||ANOVA|||An ANOVA was used to compare the Ramp Ascent Speed between the Rheo and the C-Leg 4.0.||||0.949
72444929|NCT01566695|144404563|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||<0.001
72444930|NCT01566695|144404564|SUPERIORITY|||||||0.046|||||||Fisher Exact|||||||0.046
72444931|NCT01566695|144404565|SUPERIORITY|||||||0.134|||||||Fisher Exact|||||||0.134
72444932|NCT01566695|144404566|SUPERIORITY|||||||0.324|||||||Fisher Exact|||||||0.324
72444933|NCT01566695|144404567|SUPERIORITY|||||||0.442|||||||Fisher Exact|||||||0.442
72444934|NCT01566695|144404568|SUPERIORITY|||||||0.063|||||||Fisher Exact|||||||0.063
72444935|NCT01566695|144404569|SUPERIORITY|||||||0.198|||||||Fisher Exact|||||||0.198
72444936|NCT01566695|144404570|SUPERIORITY|||||||0.972|||||||Fisher Exact|||||||0.972
72444937|NCT01566695|144404571|SUPERIORITY|||||||0.601|||||||Fisher Exact|||||||0.601
72444938|NCT01566695|144404572|SUPERIORITY|||||||0.07|||||||Fisher Exact|||||||0.070
72444939|NCT01566695|144404573|SUPERIORITY|||||||0.436|||||||Fisher Exact|||||||0.436
72444940|NCT01566695|144404574|SUPERIORITY|||||||0.683|||||||Fisher Exact|||||||0.683
72497382|NCT03094195|144524751|SUPERIORITY||LS mean difference|0.1|STANDARD_ERROR_OF_MEAN|0.53||0.914|TWO_SIDED|95.0|-1.0|1.1|||ANCOVA|||||1.1|-1.0|0.914
72560544|NCT01579006|144651512|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Wilcoxon Signed Rank Test|||||||<0.0001
72560545|NCT01579006|144651513|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Wilcoxon Signed Rank Test|||||||<0.0001
72560546|NCT01579006|144651514|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Wilcoxon Signed Rank Test|||||||<0.0001
72560547|NCT01579006|144651516|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Wilcoxon Signed Rank Test|||||||<0.0001
72560548|NCT05061992|144651518|SUPERIORITY|||||||0.6|||||||ANCOVA|||Change in SF-8||||0.6
72560549|NCT05061992|144651518|SUPERIORITY|||||||0.2|||||||ANCOVA|||End of trial SF-8||||0.2
72560550|NCT05061992|144651519|SUPERIORITY|||||||0.001|||||||ANCOVA|||Change in ANT||||0.001
72560551|NCT05061992|144651519|SUPERIORITY|||||||0.09|||||||t-test, 2 sided|||End of trial ANT||||0.09
72560552|NCT05061992|144651520|SUPERIORITY|||||||0.05|||||||ANCOVA|||||||0.05
72560553|NCT05061992|144651521|SUPERIORITY|||||||0.02|||||||ANCOVA|||||||0.02
72619248|NCT06399471|144769082|OTHER|One-way Repeated Measures ANOVA with sphericity correction (Huynh-Feldt) applied if necessary||||||0.051|||||||ANOVA|||An ANOVA was used to compare the Ramp Descent Speed for the Power Knee, C-Leg 4.0, and the Rheo when used.||||0.051
72619249|NCT06399471|144769083|OTHER|One-way Repeated Measures ANOVA with sphericity correction (Huynh-Feldt) applied if necessary||||||0.367|||||||ANOVA|||An ANOVA was used to compare the Steps per Day for the Power Knee, C-Leg 4.0, and the Rheo when used.||||0.367
72619250|NCT06083493|144769094|SUPERIORITY|||||||0.02|||||||Wilcoxon (Mann-Whitney)|||||||0.02
72497383|NCT02238847|144524755|NON_INFERIORITY|The prespecified non-inferiority margin was set at 20%. This was chosen to support a practical study size while still able to identify major differences if this were the case.|||||<|0.01||||||Reported p-value of \<0.01 is calculated p-value. (p\<0.05 was considered significant)|Exact Non-inferiority|||||||<0.01
72497384|NCT02238847|144524756|SUPERIORITY|||||||0.66|||||||Fisher Exact|||||||0.66
72497385|NCT02440581|144524776|OTHER|T-tests||||||0.443|||||||t-test, 2 sided|||||||.443
72560554|NCT05061992|144651522|SUPERIORITY|||||||0.6|||||||Fisher Exact|||||||0.6
72560555|NCT05061992|144651523|SUPERIORITY|||||||0.2|||||||t-test, 2 sided|||||||0.2
72389403|NCT00345839|144286700|SUPERIORITY_OR_OTHER_LEGACY|||||||0.283||||||No adjustments for multiple comparisons were made for the components of the primary composite endpoint since the purpose of these analyses is to show how each component contributes to the results of the composite.|Log Rank|Stratified by history of diabetes and country. 2-sided test.||||||0.283
72497386|NCT02440581|144524777|OTHER|T-tests||||||0.49|||||||t-test, 2 sided|||||||.490
72497387|NCT02440581|144524778|OTHER|T-tests|||||<|0.001|||||||t-test, 2 sided|||||||<.001
72497388|NCT02440581|144524779|OTHER|T-Tests||||||0.083|||||||t-test, 2 sided|||||||.083
72497389|NCT02440581|144524780|OTHER|T-tests||||||0.283|||||||t-test, 2 sided|||||||.283
72497390|NCT03430986|144524781|SUPERIORITY||Least Squares (LS) Mean Difference|2.037|STANDARD_ERROR_OF_MEAN|0.1578|<|0.0001|TWO_SIDED|95.0|1.726|2.349|||MMRM|MMRM included treatment, timepoint, treatment-by-timepoint interaction as fixed effect using an unstructured covariance matrix.||||2.349|1.726|<0.0001
72497391|NCT03430986|144524782|SUPERIORITY||Percentage difference|68.4|||<|0.0001|TWO_SIDED|95.0|50.0|82.4|||Fisher Exact|2-sided test comparing responder rate between treatment group and control group.||||82.4|50.0|<0.0001
72497392|NCT02022826|144524786|OTHER||percentage of agreement|76.0||||0.0052|TWO_SIDED|95.0|69.0|83.0|||McNemar|||||83|69|0.0052
72389404|NCT00345839|144286700|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.82|||||TWO_SIDED|95.0|0.58|1.18|||Regression, Cox|Stratified by history of diabetes and country.|HR is cinacalcet vs placebo.|||1.18|0.58|
72389405|NCT00345839|144286701|SUPERIORITY_OR_OTHER_LEGACY|||||||0.034||||||No adjustments for multiple comparisons were made for the components of the primary composite endpoint since the purpose of these analyses is to show how each component contributes to the results of the composite.|Log Rank|Stratified by history of diabetes and country. 2-sided test.||||||0.034
72497393|NCT02022826|144524787|OTHER||precentage of agreement|92.0||||1|TWO_SIDED|95.0|87.0|96.0|||McNemar|||||96|87|1.00
72560556|NCT01328782|144651551|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.4||||0.074||95.0|1.4|2.94|||ANOVA|||||2.94|1.40|0.074
72560557|NCT01328782|144651551|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.556||||0.556||95.0|-1.12|2.08|||ANOVA|||||2.08|-1.12|0.556
72560558|NCT01328782|144651551|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.93||||0.244||95.0|-0.64|2.49|||ANOVA|||||2.49|-0.64|0.244
72560559|NCT01328782|144651552|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.81||||0.014|TWO_SIDED|95.0|0.38|3.25|||ANOVA|||||3.25|0.38|0.014
72560560|NCT01328782|144651552|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.16||||0.832||95.0|-1.3|1.61|||ANOVA|||||1.61|-1.30|0.832
72619251|NCT06083493|144769095|SUPERIORITY|||||||0.2|||||||Wilcoxon (Mann-Whitney)|||||||0.20
72389406|NCT00345839|144286701|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.82|||||TWO_SIDED|95.0|0.68|0.99|||Regression, Cox|Stratified by history of diabetes and country.|HR is cinacalcet vs placebo.|||0.99|0.68|
72389407|NCT00345839|144286702|SUPERIORITY_OR_OTHER_LEGACY|||||||0.19||||||No adjustments for multiple comparisons were made for the components of the primary composite endpoint since the purpose of these analyses is to show how each component contributes to the results of the composite.|Log Rank|Stratified by history of diabetes and country. 2-sided test.||||||0.190
72389408|NCT00345839|144286702|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.87|||||TWO_SIDED|95.0|0.72|1.07|||Regression, Cox|Stratified by history of diabetes and country.|HR is cinacalcet vs placebo.|||1.07|0.72|
72389409|NCT00345839|144286703|SUPERIORITY_OR_OTHER_LEGACY|||||||0.277||||||No adjustments for multiple comparisons were made for this endpoint.|Log Rank|Stratified by history of diabetes and country. 2-sided test.||||||0.277
72389410|NCT00345839|144286703|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.92|||||TWO_SIDED|95.0|0.8|1.07|||Regression, Cox|Stratified by history of diabetes and country.|HR is cinacalcet vs placebo.|||1.07|0.80|
72389411|NCT00345839|144286704|SUPERIORITY_OR_OTHER_LEGACY|||||||0.607||||||No adjustments for multiple comparisons were made for this endpoint.|Log Rank|Stratified by history of diabetes and country. 2-sided test.||||||0.607
72389412|NCT00345839|144286704|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.07|||||TWO_SIDED|95.0|0.82|1.4|||Regression, Cox|Stratified by history of diabetes and country.|HR is cinacalcet vs placebo.|||1.40|0.82|
72389413|NCT00345839|144286705|SUPERIORITY_OR_OTHER_LEGACY|||||||0.218||||||No adjustments for multiple comparisons were made for this endpoint.|Log Rank|Stratified by history of diabetes and country. 2-sided test.||||||0.218
72389414|NCT00345839|144286705|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.89|||||TWO_SIDED|95.0|0.75|1.07|||Regression, Cox|Stratified by history of diabetes and country.|HR is cinacalcet vs placebo.|||1.07|0.75|
72389415|NCT00345839|144286706|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||No adjustments for multiple comparisons were made for this endpoint.|Log Rank|Stratified by history of diabetes and country. 2-sided test.||||||<0.001
72389416|NCT00345839|144286706|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.44|||||TWO_SIDED|95.0|0.36|0.54|||Regression, Cox|Stratified by history of diabetes and country.|HR is cinacalcet vs placebo.|||0.54|0.36|
72389417|NCT01960400|144286707|SUPERIORITY_OR_OTHER|||||||0.065||||||"The statistical signifiance level : p\<0.05. After treatment (T1) Pain severity p=0.065~Sub-scale:~* Present pain p=0.046\*~* Average pain p=0.381~* Most intense pain p=0.064~* Least intense pain p=0.142"|ANOVA|To assess the effectiveness of interventions (inter-group differences), a mixed-model ANOVA (time X group interaction) was used.||For the severity of pain, the calculations have revealed that only this pain now had an acceptable statistical power, of 77.1% after treatment (T1).||||0.065
72389418|NCT01960400|144286708|SUPERIORITY_OR_OTHER|||||||0.049||||||interaction group X time|ANOVA|||||||0.049
72389419|NCT01960400|144286709|SUPERIORITY_OR_OTHER|||||||0.035||||||interaction group X time|ANOVA|||||||0.035
72389420|NCT01960400|144286710|SUPERIORITY_OR_OTHER|||||||0.046||||||interaction group X time|ANOVA|||||||0.046
72389421|NCT00743483|144286711|SUPERIORITY_OR_OTHER|||||||0.2179|TWO_SIDED||||||t-test, 2 sided|||||||0.2179
72497394|NCT01583374|144524800|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|-4.1||||0.4383|TWO_SIDED|95.0|-14.3|6.2|||Cochran-Mantel-Haenszel|2 sided p-value was based on CMH test adjusting for C-reactive protein (CRP) category and baseline BASDAI score category|Adjusted difference is the weighted average of the treatment differences across the 4 strata of screening CRP category and baseline BASDAI score category with the Cochran-Mantel-Haenszel (CMH) weights|||6.2|-14.3|0.4383
72444941|NCT03940963|144404600|NON_INFERIORITY|The visual analog scale (VAS, 0-100 scale) pain score change from baseline value to 12 months was tested for non-inferiority of neurectomy with Axoguard Nerve Cap to standard neurectomy alone using closed testing procedures.||||||0.011||||||The threshold for statistical significance was p = 0.05.|t-test, 2 sided|||||||0.011
72444942|NCT03940963|144404603|EQUIVALENCE|A predefined equivalence margin was not considered.||||||0.485||||||The threshold for statistical significance was p = 0.05.|t-test, 2 sided|||||||0.485
72444943|NCT03940963|144404604|EQUIVALENCE|A predefined equivalence margin was not considered.||||||0.259||||||The threshold for statistical significance was p = 0.05.|t-test, 2 sided|||||||0.259
72444944|NCT03940963|144404605|EQUIVALENCE|A predefined equivalence margin was not considered.||||||0.14||||||The threshold for statistical significance was p = 0.05.|t-test, 2 sided|||||||0.140
72444945|NCT03940963|144404606|EQUIVALENCE|A predefined equivalence margin was not considered.||||||0.544||||||The threshold for statistical significance was p = 0.05.|t-test, 2 sided|||||||0.544
72444946|NCT03940963|144404608|EQUIVALENCE|A predefined equivalence margin was not considered.||||||0.049||||||The threshold for statistical significance was p = 0.05.|t-test, 2 sided|||||||0.049
72444947|NCT01809691|144404615|SUPERIORITY||Hazard Ratio (HR)|0.86||||0.08|TWO_SIDED|95.0|0.72|1.02|||Regression, Cox|||||1.02|0.72|.080
72444948|NCT01809691|144404616|SUPERIORITY||Hazard Ratio (HR)|0.58|||<|0.001|TWO_SIDED|95.0|0.51|0.67|||Regression, Cox|||||0.67|0.51|<0.001
72497395|NCT01583374|144524800|SUPERIORITY||Risk Difference (RD)|-1.7||||0.7427|TWO_SIDED|95.0|-12.0|8.5|||Cochran-Mantel-Haenszel|2 sided p-value was based on CMH test adjusting for C-reactive protein (CRP) category and baseline BASDAI score category|Adjusted difference in proportions is the weighted average of the treatment differences across the 4 strata of screening CRP category and baseline BASDAI score category with the Cochran-Mantel-Haenszel weights.|||8.5|-12.0|0.7427
72497396|NCT01583374|144524801|SUPERIORITY||LS Mean Difference|-0.05||||0.8032|TWO_SIDED|95.0|-0.41|0.32|||ANCOVA|Based on an ANCOVA model for change from baseline with treatment group, CRP and baseline BASDAI score as factors and baseline value as covariate.||||0.32|-0.41|0.8032
72497397|NCT01583374|144524801|SUPERIORITY||LS Mean Difference|-0.17||||0.3624|TWO_SIDED|95.0|-0.53|0.19|||ANCOVA|Based on an ANCOVA model for change from baseline with treatment group, CRP and baseline BASDAI score as factors and baseline value as covariate.||||0.19|-0.53|0.3624
72497398|NCT01583374|144524802|SUPERIORITY||LS Mean Difference|0.03||||0.8618|TWO_SIDED|95.0|-0.33|0.4|||ANCOVA|Based on an ANCOVA model for change from baseline with treatment group, CRP and baseline BASDAI score as factors and baseline value as covariate.||||0.40|-0.33|0.8618
72497399|NCT01583374|144524802|SUPERIORITY||LS Mean Difference|-0.09||||0.6262|TWO_SIDED|95.0|-0.45|0.27|||ANCOVA|Based on an ANCOVA model for change from baseline with treatment group, CRP and baseline BASDAI score as factors and baseline value as covariate.||||0.27|-0.45|0.6262
72444949|NCT03892616|144404644|OTHER||Ratio of adjusted geometric means [%]|97.4|||||TWO_SIDED|90.0|82.3|115.3|||||The ratio was calculated as adjusted geometric mean of TF2a fasted (C) as numerator and adjusted geometric mean of TF1 fed (A) as denominator, \*100. Intra-individual geometric coefficient of variation (gCV \[%\]) = 25.44|Relative bioavailability: ratio of adjusted geometric means was calculated using an analysis of variance (ANOVA). The model on logarithmic scale included random effect of 'subjects within sequences' and fixed effect of 'sequence or block', 'period', 'treatment'.||115.3|82.3|
72444950|NCT03892616|144404644|OTHER||Ratio of adjusted geometric means [%]|183.0|||||TWO_SIDED|90.0|154.0|217.4|||||The ratio was calculated as adjusted geometric mean of TF2b fasted (E) as numerator and adjusted geometric mean of TF1 fed (A) as denominator, \*100. Intra-individual geometric coefficient of variation (gCV \[%\]) = 25.44|Relative bioavailability: ratio of adjusted geometric means was calculated using an analysis of variance (ANOVA). The model on logarithmic scale included random effect of 'subjects within sequences' and fixed effect of 'sequence or block', 'period', 'treatment'.||217.4|154.0|
72444951|NCT03892616|144404644|OTHER||Ratio of adjusted geometric means [%]|114.8|||||TWO_SIDED|90.0|96.5|136.6|||||The ratio was calculated as adjusted geometric mean of TF2a fed (B) as numerator and adjusted geometric mean of TF2a fasted (C) as denominator, \*100. Intra-individual geometric coefficient of variation (gCV \[%\]) = 25.44|Relative bioavailability: ratio of adjusted geometric means was calculated using an analysis of variance (ANOVA). The model on logarithmic scale included random effect of 'subjects within sequences' and fixed effect of 'sequence or block', 'period', 'treatment'.||136.6|96.5|
72444952|NCT03892616|144404644|OTHER||Ratio of adjusted geometric means [%]|66.5|||||TWO_SIDED|90.0|55.5|79.5|||||The ratio was calculated as adjusted geometric mean of TF2b fed (D) as numerator and adjusted geometric mean of TF2b fasted (E) as denominator, \*100. Intra-individual geometric coefficient of variation (gCV \[%\]) = 25.44|Relative bioavailability: ratio of adjusted geometric means was calculated using an analysis of variance (ANOVA). The model on logarithmic scale included random effect of 'subjects within sequences' and fixed effect of 'sequence or block', 'period', 'treatment'.||79.5|55.5|
72444953|NCT03892616|144404645|OTHER||Ratio of adjusted geometric means [%]|60.2|||||TWO_SIDED|90.0|55.3|65.5|||||The ratio was calculated as adjusted geometric mean of TF2a fasted (C) as numerator and adjusted geometric mean of TF1 fed (A) as denominator, \*100. Intra-individual geometric coefficient of variation (gCV \[%\]) = 12.65|Relative bioavailability: ratio of adjusted geometric means was calculated using an analysis of variance (ANOVA). The model on logarithmic scale included random effect of 'subjects within sequences' and fixed effect of 'sequence or block', 'period', 'treatment'.||65.5|55.3|
72444954|NCT03892616|144404645|OTHER||Ratio of adjusted geometric means [%]|71.5|||||TWO_SIDED|90.0|65.6|78.0|||||The ratio was calculated as adjusted geometric mean of TF2b fasted (E) as numerator and adjusted geometric mean of TF1 fed (A) as denominator, \*100. Intra-individual geometric coefficient of variation (gCV \[%\]) = 12.65|Relative bioavailability: ratio of adjusted geometric means was calculated using an analysis of variance (ANOVA). The model on logarithmic scale included random effect of 'subjects within sequences' and fixed effect of 'sequence or block', 'period', 'treatment'.||78.0|65.6|
72560561|NCT01328782|144651552|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.66||||0.027||95.0|0.2|3.12|||ANOVA|||||3.12|0.20|0.027
72560562|NCT01328782|144651553|SUPERIORITY_OR_OTHER|||||||0.005||95.0|||||Log Rank|||||||0.005
72389422|NCT01466153|144286712|SUPERIORITY_OR_OTHER|||||||0.4475|||||||Cochran-Mantel-Haenszel|||||||0.4475
72560563|NCT01328782|144651553|SUPERIORITY_OR_OTHER|||||||0.3767||95.0|||||Log Rank|||||||0.3767
72560564|NCT01328782|144651553|SUPERIORITY_OR_OTHER|||||||0.039||95.0|||||Log Rank|||||||0.039
72619252|NCT00601107|144769105|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.84||||1|TWO_SIDED|95.0|0.17|4.22||The p-value was not adjusted for multiple comparisons or a prior significance threshold.|Regression, Exact Logistic|||Estimate of the log odds, relative to the Placebo, in participants with at least 50 % reduction in PASI score at Week 12 or early termination was analyzed using exact logistic regression model adjusted for site and baseline PASI strata (\<=16, \>16).||4.22|0.17|1.000
72619253|NCT00601107|144769105|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.76||||0.992||95.0|0.13|4.14||The p-value was not adjusted for multiple comparisons or a prior significance threshold.|Regression, Exact Logistic|||Estimate of the log odds, relative to the Placebo, in participants with at least 50 % reduction in PASI score at Week 12 or early termination was analyzed using exact logistic regression model adjusted for site and baseline PASI strata (\<=16, \>16).||4.14|0.13|0.992
72389423|NCT01466153|144286716|SUPERIORITY_OR_OTHER|||||||0.3206|||||||Cochran-Mantel-Haenszel|||||||0.3206
72389424|NCT01466153|144286717|SUPERIORITY_OR_OTHER|||||||0.313|||||||Cochran-Mantel-Haenszel|||||||0.3130
72389425|NCT01466153|144286719|SUPERIORITY_OR_OTHER|||||||0.9527|||||||Log Rank|||||||0.9527
72389426|NCT01153347|144286733|SUPERIORITY_OR_OTHER||LS mean|-0.9|STANDARD_ERROR_OF_MEAN|1.07||1|TWO_SIDED|95.0|-2.96|1.24||The adjusted p-value protects the overall family-wise error rate by taking into account the multiple comparisons between the TC-5214 doses for both the primary efficacy variable (MADRS) and the key secondary efficacy variable (SDS).|MMRM|||Mixed model repeated measures (MMRM) includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization MADRS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||1.24|-2.96|1.000
72389427|NCT01153347|144286733|SUPERIORITY_OR_OTHER||LS mean|-0.6|STANDARD_ERROR_OF_MEAN|1.08||1|TWO_SIDED|95.0|-2.67|1.57|||MMRM|||Mixed model repeated measures (MMRM) includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization MADRS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||1.57|-2.67|1.000
72389428|NCT01153347|144286733|SUPERIORITY_OR_OTHER||LS mean|-0.1|STANDARD_ERROR_OF_MEAN|1.09||1|TWO_SIDED|95.0|-2.26|2.04|||MMRM|||Mixed model repeated measures (MMRM) includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization MADRS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||2.04|-2.26|1.000
72389429|NCT01153347|144286734|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.01|STANDARD_ERROR_OF_MEAN|0.24||0.967|TWO_SIDED|95.0|0.64|1.6|||Regression, Logistic||TC-5214 is the numerator in the OR, OR\>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization MADRS total score as a covariate.||1.60|0.64|0.967
72389430|NCT01153347|144286734|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.9|STANDARD_ERROR_OF_MEAN|0.21||0.67|TWO_SIDED|95.0|0.57|1.43|||Regression, Logistic||TC-5214 is the numerator in the OR, OR\>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization MADRS total score as a covariate.||1.43|0.57|0.670
72389431|NCT01153347|144286734|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.87|STANDARD_ERROR_OF_MEAN|0.21||0.544|TWO_SIDED|95.0|0.54|1.38|||Regression, Logistic||TC-5214 is the numerator in the OR, OR\>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization MADRS total score as a covariate.||1.38|0.54|0.544
72389432|NCT01153347|144286735|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.91|STANDARD_ERROR_OF_MEAN|0.24||0.73|TWO_SIDED|95.0|0.55|1.53|||Regression, Logistic||TC-5214 is the numerator in the OR, OR\>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization MADRS total score as a covariate.||1.53|0.55|0.730
72389433|NCT01153347|144286735|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.89|STANDARD_ERROR_OF_MEAN|0.23||0.671|TWO_SIDED|95.0|0.53|1.5|||Regression, Logistic||TC-5214 is the numerator in the OR, OR\>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization MADRS total score as a covariate.||1.50|0.53|0.671
72389434|NCT01153347|144286735|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.76|STANDARD_ERROR_OF_MEAN|0.2||0.308|TWO_SIDED|95.0|0.45|1.29|||Regression, Logistic||TC-5214 is the numerator in the OR, OR\>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization MADRS total score as a covariate.||1.29|0.45|0.308
72389435|NCT01153347|144286736|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.95|STANDARD_ERROR_OF_MEAN|0.4||0.905|TWO_SIDED|95.0|0.42|2.15|||Regression, Logistic||TC-5214 is the numerator in the OR, OR\>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization MADRS total score as a covariate.||2.15|0.42|0.905
72560565|NCT01328782|144651554|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.042||||0.008||95.0|0.008|0.076|||ANOVA|||||0.076|0.008|0.008
72560566|NCT01328782|144651554|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.031||||0.078||95.0|-0.004|0.066|||ANOVA|||||0.066|-0.004|0.078
72560567|NCT01328782|144651554|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.011||||0.5321||95.0|-0.024|0.045|||ANOVA|||||0.045|-0.024|0.5321
72560568|NCT01328782|144651555|SUPERIORITY_OR_OTHER|||||||0.004||95.0|||||Chi-squared|||||||0.004
72560569|NCT01328782|144651555|SUPERIORITY_OR_OTHER|||||||0.004||95.0|||||Chi-squared|||||||0.004
72560570|NCT01328782|144651555|SUPERIORITY_OR_OTHER|||||||0.499||95.0|||||Chi-squared|||||||0.499
72560571|NCT04535986|144651556|SUPERIORITY||LS mean difference|0.0868|STANDARD_ERROR_OF_MEAN|0.0162|<|0.0001|TWO_SIDED|95.0|0.0551|0.1185||The analysis of covariance (ANCOVA) model was used to model the change from baseline FEV1 to average FEV1 AUC0-12h with treatment, region, background medication strata and smoking strata as fixed effects and baseline FEV1 as covariate.|ANCOVA|||||0.1185|0.0551|<0.0001
72560572|NCT01993940|144651588|SUPERIORITY_OR_OTHER||Difference|18.9|STANDARD_ERROR_OF_MEAN|4.12|<|0.0001|TWO_SIDED|95.0|10.8|27.0||To control the overall type I error rate to be ≤ 0.05 for the primary and secondary efficacy endpoints, a fixed-sequence (hierarchical) testing approach was applied.|Cochran-Mantel-Haenszel|P-value was calculated by Cochran-Mantel-Haenszel test adjusted by the opioid dose strata.||||27.0|10.8|<0.0001
72560573|NCT01993940|144651589|SUPERIORITY_OR_OTHER||LS Mean Difference|1.4|STANDARD_ERROR_OF_MEAN|0.243|<|0.0001|TWO_SIDED|95.0|0.92|1.88|||ANCOVA|The ANCOVA model has the terms for treatment group as a fixed effect and the opioid dose strata as a covariate.||||1.88|0.92|<0.0001
72560574|NCT01993940|144651590|SUPERIORITY_OR_OTHER||LS Mean Difference|2.17|STANDARD_ERROR_OF_MEAN|0.277|<|0.0001|TWO_SIDED|95.0|1.63|2.71|||ANCOVA|The ANCOVA model has the terms for treatment group as a fixed effect and the opioid dose strata as a covariate.||||2.71|1.63|<0.0001
72560575|NCT01993940|144651591|SUPERIORITY_OR_OTHER||LS Mean Difference|1.15|STANDARD_ERROR_OF_MEAN|0.232|<|0.0001|TWO_SIDED|95.0|0.7|1.61|||ANCOVA|The ANCOVA model has the terms for treatment group as a fixed effect and the opioid dose strata as a covariate.||||1.61|0.70|<0.0001
72560576|NCT01993940|144651592|SUPERIORITY_OR_OTHER||LS Mean Difference|0.75|STANDARD_ERROR_OF_MEAN|0.227||0.0011|TWO_SIDED|95.0|0.3|1.19|||ANCOVA|The ANCOVA model has the terms for treatment group as a fixed effect and the opioid dose strata as a covariate.||||1.19|0.30|0.0011
72560577|NCT01567527|144651593|SUPERIORITY||Hazard Ratio (HR)|0.451|||<|0.0001|TWO_SIDED|95.0|0.299|0.678|||Log Rank||"Using the Cox proportional hazards model with term for treatment group.~HR is estimated for Aripiprazole IM depot relative to Placebo."|Significance level 0.05.||0.678|0.299|< 0.0001
72560578|NCT01567527|144651593|SUPERIORITY|Using the Cox proportional hazards model with term for treatment group.|Hazard Ratio (HR)|2.22|||||TWO_SIDED|95.0|1.475|3.34|||||HR is estimated for Placebo relative to Aripiprazole IM depot.|||3.34|1.475|
72619254|NCT00601107|144769105|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.85||||1|TWO_SIDED|95.0|0.15|4.59||The p-value was not adjusted for multiple comparisons or a prior significance threshold.|Regression, Exact Logistic|||Estimate of the log odds, relative to the Placebo, in participants with at least 50 % reduction in PASI score at Week 12 or early termination was analyzed using exact logistic regression model adjusted for site and baseline PASI strata (\<=16, \>16).||4.59|0.15|1.000
72619255|NCT00147537|144769110|SUPERIORITY_OR_OTHER||||||=|0.027|TWO_SIDED||||||binomial test|||A one-sided p-value for H0: objective response rate \<=0.28 using exact binomial test at level 0.05.||||=0.027
72619256|NCT00147537|144769111|SUPERIORITY_OR_OTHER||||||=|0.121|TWO_SIDED||||||binomial test|||A One-sided p-value for H0: objective response rate \<=0.30 using exact binomial test at level 0.05.||||=0.121
72619257|NCT00345592|144769141|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.987|||||TWO_SIDED|95.0|0.684|1.503||||||||1.503|0.684|
72619258|NCT02006654|144769149|SUPERIORITY||Mean Difference (Final Values)|-0.55|STANDARD_ERROR_OF_MEAN|0.46||0.2365|TWO_SIDED|95.0|-1.45|0.36||Corrected for multiplicity|Mixed Models Analysis|Adjusted for effects of country, MMSE stratum-by-week, treatment-by-week, base treatment stratum-by-week, and baseline score-by-week interactions|A negative mean difference indicates a treatment effect in favor of idalopirdine|For demonstrating efficacy, change in cognition (ADAS-cog) and either change in daily functioning (ADCS-ADL23) or change in global clinical impression (ADCS-CGIC) had to show statistically significant favourable differences compared to placebo at Week 24. Multiple testing procedures were used to control the overall type 1 error at 5%. The null hypothesis of no difference in mean change from baseline in ADAS-cog total score at Week 24 was tested for idalopirdine at significance level 5%.||0.36|-1.45|0.2365
72622391|NCT00855166|144774683|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.45|STANDARD_ERROR_OF_MEAN|0.4428||0.3105|TWO_SIDED|95.0|-1.32|0.43||Exploratory. Model including fixed categorical effects of treatment, week, treatment-by-week interaction, gender and rescue medication as well as continuous fixed covariates of baseline measurement and baseline measurement-by-week interaction.|Mixed Models Analysis|Percent change in BMD from baseline to week 102 evaluated via longitudinal repeated measures analysis using direct likelihood.|Natural logarithms of baseline and week 102 values were used.|H0: mean(treat) minus mean(placebo) = 0 versus the alternative HA: mean(treat) minus mean(placebo) =/= 0||0.43|-1.32|0.3105
72444955|NCT03892616|144404645|OTHER||Ratio of adjusted geometric means [%]|177.9|||||TWO_SIDED|90.0|162.8|194.3|||||The ratio was calculated as adjusted geometric mean of TF2a fed (B) as numerator and adjusted geometric mean of TF2a fasted (C) as denominator, \*100. Intra-individual geometric coefficient of variation (gCV \[%\]) = 12.65|Relative bioavailability: ratio of adjusted geometric means was calculated using an analysis of variance (ANOVA). The model on logarithmic scale included random effect of 'subjects within sequences' and fixed effect of 'sequence or block', 'period', 'treatment'.||194.3|162.8|
72444956|NCT03892616|144404645|OTHER||Ratio of adjusted geometric means [%]|152.9|||||TWO_SIDED|90.0|139.5|167.7|||||The ratio was calculated as adjusted geometric mean of TF2b fed (D) as numerator and adjusted geometric mean of TF2b fasted (E) as denominator, \*100. Intra-individual geometric coefficient of variation (gCV \[%\]) = 12.65|Relative bioavailability: ratio of adjusted geometric means was calculated using an analysis of variance (ANOVA). The model on logarithmic scale included random effect of 'subjects within sequences' and fixed effect of 'sequence or block', 'period', 'treatment'.||167.7|139.5|
72444957|NCT03892616|144404646|OTHER||Ratio of adjusted geometric means [%]|60.3|||||TWO_SIDED|90.0|55.4|65.7|||||The ratio was calculated as adjusted geometric mean of TF2a fasted (C) as numerator and adjusted geometric mean of TF1 fed (A) as denominator, \*100. Intra-individual geometric coefficient of variation (gCV \[%\]) = 12.70|Relative bioavailability: ratio of adjusted geometric means was calculated using an analysis of variance (ANOVA). The model on logarithmic scale included random effect of 'subjects within sequences' and fixed effect of 'sequence or block', 'period', 'treatment'.||65.7|55.4|
72444958|NCT03892616|144404646|OTHER||Ratio of adjusted geometric means [%]|71.1|||||TWO_SIDED|90.0|65.2|77.6|||||The ratio was calculated as adjusted geometric mean of TF2b fasted (E) as numerator and adjusted geometric mean of TF1 fed (A) as denominator, \*100. Intra-individual geometric coefficient of variation (gCV \[%\]) = 12.70|Relative bioavailability: ratio of adjusted geometric means was calculated using an analysis of variance (ANOVA). The model on logarithmic scale included random effect of 'subjects within sequences' and fixed effect of 'sequence or block', 'period', 'treatment'.||77.6|65.2|
72560579|NCT01567527|144651594|SUPERIORITY|Using a hierarchical procedure to preserve the overall Type I error rate at 0.05, after testing the primary outcome.|Percentage Difference (Final Values)|-24.6|||<|0.0001|TWO_SIDED|95.0|-36.7|-12.5|||Fisher Exact|||Statistical analysis for any mood episode||-12.5|-36.7|< 0.0001
72560580|NCT01567527|144651595|SUPERIORITY|Using mixed model repeated measures (MMRM) analysis with a restricted maximum likelihood (REML) approach. Analyses included the categorically fixed effects of treatment, region, trial week, and treatment-by-week interaction, as well as the continuously fixed covariates of baseline-score-by-week interaction. An unstructured covariance structure was used to model the within-subject errors and Kenward-Rodger degree of freedom was used to test the fixed effects.|Mean Difference (Final Values)|-0.43|||=|0.0011|TWO_SIDED|95.0|-0.69|-0.17|||Mixed model repeated measure analysis|||||-0.17|-0.69|= 0.0011
72444959|NCT03892616|144404646|OTHER||Ratio of adjusted geometric means [%]|175.8|||||TWO_SIDED|90.0|160.8|192.2|||||The ratio was calculated as adjusted geometric mean of TF2a fed (B) as numerator and adjusted geometric mean of TF2a fasted (C) as denominator, \*100. Intra-individual geometric coefficient of variation (gCV \[%\]) = 12.70|Relative bioavailability: ratio of adjusted geometric means was calculated using an analysis of variance (ANOVA). The model on logarithmic scale included random effect of 'subjects within sequences' and fixed effect of 'sequence or block', 'period', 'treatment'.||192.2|160.8|
72444960|NCT03892616|144404646|OTHER||Ratio of adjusted geometric means [%]|150.2|||||TWO_SIDED|90.0|136.9|164.7|||||The ratio was calculated as adjusted geometric mean of TF2b fed (D) as numerator and adjusted geometric mean of TF2b fasted (E) as denominator, \*100. Intra-individual geometric coefficient of variation (gCV \[%\]) = 12.70|Relative bioavailability: ratio of adjusted geometric means was calculated using an analysis of variance (ANOVA). The model on logarithmic scale included random effect of 'subjects within sequences' and fixed effect of 'sequence or block', 'period', 'treatment'.||164.7|136.9|
72444961|NCT03892616|144404647|OTHER||Ratio of adjusted geometric means [%]|56.5|||||TWO_SIDED|90.0|51.8|61.7|||||The ratio was calculated as adjusted geometric mean of TF2a fasted (C) as numerator and adjusted geometric mean of TF1 fed (A) as denominator, \*100. Intra-individual geometric coefficient of variation (gCV \[%\]) = 13.02|Relative bioavailability: ratio of adjusted geometric means was calculated using an analysis of variance (ANOVA). The model on logarithmic scale included random effect of 'subjects within sequences' and fixed effect of 'sequence or block', 'period', 'treatment'.||61.7|51.8|
72444962|NCT03892616|144404647|OTHER||Ratio of adjusted geometric means [%]|70.5|||||TWO_SIDED|90.0|64.4|77.1|||||The ratio was calculated as adjusted geometric mean of TF2b fasted (E) as numerator and adjusted geometric mean of TF1 fed (A) as denominator, \*100. Intra-individual geometric coefficient of variation (gCV \[%\]) = 13.02|Relative bioavailability: ratio of adjusted geometric means was calculated using an analysis of variance (ANOVA). The model on logarithmic scale included random effect of 'subjects within sequences' and fixed effect of 'sequence or block', 'period', 'treatment'.||77.1|64.4|
72444963|NCT03892616|144404647|OTHER||Ratio of adjusted geometric means [%]|185.3|||||TWO_SIDED|90.0|169.4|202.8|||||The ratio was calculated as adjusted geometric mean of TF2a fed (B) as numerator and adjusted geometric mean of TF2a fasted (C) as denominator, \*100. Intra-individual geometric coefficient of variation (gCV \[%\]) = 13.02|Relative bioavailability: ratio of adjusted geometric means was calculated using an analysis of variance (ANOVA). The model on logarithmic scale included random effect of 'subjects within sequences' and fixed effect of 'sequence or block', 'period', 'treatment'.||202.8|169.4|
72444964|NCT03892616|144404647|OTHER||Ratio of adjusted geometric means [%]|158.4|||||TWO_SIDED|90.0|144.3|173.9|||||The ratio was calculated as adjusted geometric mean of TF2b fed (D) as numerator and adjusted geometric mean of TF2b fasted (E) as denominator, \*100. Intra-individual geometric coefficient of variation (gCV \[%\]) = 13.02|Relative bioavailability: ratio of adjusted geometric means was calculated using an analysis of variance (ANOVA). The model on logarithmic scale included random effect of 'subjects within sequences' and fixed effect of 'sequence or block', 'period', 'treatment'.||173.9|144.3|
72497400|NCT01583374|144524803|SUPERIORITY||Risk Difference (RD)|2.0||||0.6958|TWO_SIDED|95.0|-8.1|12.2|||Cochran-Mantel-Haenszel|2 sided p-value was based on the CMH test adjusting for C-reactive protein (CRP) category and baseline BASDAI score category.|Adjusted difference is the weighted average of the treatment differences across the 4 strata of screening CRP category and baseline BASDAI score category with the Cochran-Mantel-Haenszel weights.|||12.2|-8.1|0.6958
72497401|NCT01583374|144524803|SUPERIORITY||Risk Difference (RD)|4.4||||0.4051|TWO_SIDED|95.0|-5.8|14.5|||Cochran-Mantel-Haenszel|2 sided p-value was based on the CMH test adjusting for C-reactive protein (CRP) category and baseline BASDAI score category.|Adjusted difference is the weighted average of the treatment differences across the 4 strata of screening CRP category and baseline BASDAI score category with the Cochran-Mantel-Haenszel weights.|||14.5|-5.8|0.4051
72497402|NCT01583374|144524804|SUPERIORITY||LS Mean Difference|0.25||||0.5126|TWO_SIDED|95.0|-0.49|0.99|||ANCOVA|Based on an ANCOVA model for change from baseline with treatment group, CRP and baseline BASDAI score as factors and baseline value as covariate.||||0.99|-0.49|0.5126
72497403|NCT01583374|144524804|SUPERIORITY||LS Mean Difference|0.28||||0.4624|TWO_SIDED|95.0|-0.46|1.01|||ANCOVA|Based on an ANCOVA model for change from baseline with treatment group, CRP and baseline BASDAI score as factors and baseline value as covariate.||||1.01|-0.46|0.4624
72444965|NCT01787383|144404668|SUPERIORITY_OR_OTHER_LEGACY|||||||0.13|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.13
72444966|NCT01787383|144404669|SUPERIORITY_OR_OTHER_LEGACY|||||||0.34|TWO_SIDED||||||Regression, Logistic|||||||0.34
72444967|NCT01787383|144404670|SUPERIORITY_OR_OTHER_LEGACY|||||||0.088|TWO_SIDED||||||Regression, Logistic|||||||0.088
72497404|NCT01583374|144524805|SUPERIORITY||LS Mean Difference|0.29||||0.6997|TWO_SIDED|95.0|-1.18|1.76|||ANCOVA|Based on an ANCOVA model for change from baseline with treatment group, CRP and baseline BASDAI score as factors and baseline value as covariate.||||1.76|-1.18|0.6997
72497405|NCT01583374|144524805|SUPERIORITY||LS Mean Difference|-0.04||||0.9587|TWO_SIDED|95.0|-1.5|1.42|||ANCOVA|Based on an ANCOVA model for change from baseline with treatment group, CRP and baseline BASDAI score as factors and baseline value as covariate.||||1.42|-1.50|0.9587
72497406|NCT01583374|144524806|SUPERIORITY||LS Mean Difference|0.06||||0.3307|TWO_SIDED|95.0|-0.06|0.17|||ANCOVA|Based on an ANCOVA model for change from baseline with treatment group, CRP and baseline BASDAI score as factors and baseline value as covariate.||||0.17|-0.06|0.3307
72560581|NCT01567527|144651596|SUPERIORITY||Hazard Ratio (HR)|0.137|||=|0.0002|TWO_SIDED|95.0|0.04|0.465|||Log Rank||"Using the Cox proportional hazards model with term for treatment group.~HR is estimated for Aripiprazole IM depot relative to Placebo."|||0.465|0.04|= 0.0002
72560582|NCT01567527|144651596|SUPERIORITY|Using the Cox proportional hazards model with term for treatment group.|Hazard Ratio (HR)|7.313|||||TWO_SIDED|95.0|2.151|24.865|||||HR is estimated for Placebo relative to Aripiprazole IM depot.|||24.865|2.151|
72444968|NCT01787383|144404671|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.20
72560583|NCT02004691|144651598|SUPERIORITY||Least Squares Mean Difference|19.008|STANDARD_ERROR_OF_MEAN|4.7576|=|0.0004|TWO_SIDED|95.0|9.319|28.696||Threshold for significance was 0.05.|Mixed model for repeated measures||The 95% Confidence Interval (CI) and p-values were based on mixed model for repeated measures approach with Baseline Derived % Predicted DLco adjusted for Hb and pressure, age, treatment group, visit, and study visit by treatment group as covariates.|||28.696|9.319|=0.0004
72444969|NCT01787383|144404672|SUPERIORITY_OR_OTHER_LEGACY|||||||0.38|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.38
72444970|NCT01787383|144404673|SUPERIORITY_OR_OTHER_LEGACY|||||||0.033|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.033
72444971|NCT01787383|144404674|SUPERIORITY_OR_OTHER_LEGACY|||||||0.37|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.37
72444972|NCT01787383|144404675|SUPERIORITY_OR_OTHER_LEGACY|||||||0.66|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.66
72444973|NCT04533347|144404676|SUPERIORITY|||||||0.1879|TWO_SIDED|95.0|||||Fisher Exact|||Assuming an 85% clinical recovery rate in the TQ group and a 70% clinical recovery rate in the placebo group, sample sizes of 125 per treatment group were expected to achieve 80% power with a two-sided alpha of 0.05.||||0.1879
72444974|NCT03562377|144404712|NON_INFERIORITY|The difference in response rates was calculated using the Mantel-Haenszel estimate of the risk difference stratified by baseline disease severity together with the 2-sided 95% CI. Non-inferiority of tralokinumab was demonstrated if the lower limit of the 95% CI was greater than -25%. Power calculation assumed 160 subjects in the per protocol analysis set, providing 98% power to establish non-inferiority, assuming response rates of 80% in both treatment groups and a non-inferiority margin of -25%|Risk Difference (RD)|-4.1|||||TWO_SIDED|95.0|-11.3|3.1|||Mantel Haenszel|||||3.1|-11.3|
72444975|NCT03562377|144404713|NON_INFERIORITY|The difference in response rates was calculated using the Mantel-Haenszel estimate of the risk difference stratified by baseline disease severity together with the 2-sided 95% CI. Non-inferiority of tralokinumab was demonstrated if the lower limit of the 95% CI was greater than -25%. Power calculation assumed 160 subjects in the per protocol analysis set, providing 98% power to establish non-inferiority, assuming response rates of 80% in both treatment groups and a non-inferiority margin of -25%|Risk Difference (RD)|1.8|||||TWO_SIDED|95.0|-9.2|12.8|||Mantel Haenszel|||||12.8|-9.2|
72444976|NCT03562377|144404714|SUPERIORITY||Risk Difference (RD)|11.4||||0.049|TWO_SIDED|95.0|0.2|22.6||The p-value was adjusted for multiplicity by a pre-specified testing hierarchy. Subjects with missing data or subjects who received rescue medication prior to Week 16 were considered non-responders in the primary analysis of the primary estimand.|Cochran-Mantel-Haenszel|The difference in response rates was analysed using the Cochran-Mantel-Haenszel test stratified by baseline disease severity (moderate or severe).||||22.6|0.2|0.049
72619259|NCT02006654|144769150|SUPERIORITY||Mean Difference (Final Values)|0.07|STANDARD_ERROR_OF_MEAN|0.08||0.4064|TWO_SIDED|95.0|-0.09|0.23||Corrected for multiplicity according to the multiple testing procedure|Mixed Models Analysis|Adjusted for effects of country, MMSE stratum-by-week, treatment-by-week, base treatment stratum-by-week, and baseline score-by-week interactions|A negative mean difference indicates a treatment effect in favor of idalopirdine|For demonstrating efficacy, change in cognition (ADAS-cog) and either change in daily functioning (ADCS-ADL23) or change in global clinical impression (ADCS-CGIC) had to show statistically significant favourable differences compared to placebo at Week 24. Multiple testing procedures were used to control the overall type 1 error at 5%. The null hypothesis of no difference in mean change from baseline in ADAS-cog total score at Week 24 was tested at significance level 5%.||0.23|-0.09|0.4064
72622392|NCT02702999|144774684|SUPERIORITY||Risk Ratio (RR)|3.9|||||TWO_SIDED|95.0|0.9|18.0|||||The intervention arm and control arm were compared using a log binomial (or Poisson in case of nonconvergence) model with the intervention arm as a covariate to estimate relative risk and 95% confidence interval (CI).|||18.0|0.9|
72444977|NCT03562377|144404715|SUPERIORITY||Risk Difference (RD)|12.7||||0.057|TWO_SIDED|95.0|-0.2|25.7||The p-value was adjusted for multiplicity by a pre-specified testing hierarchy. Subjects with missing data or subjects who received rescue medication prior to Week 16 were considered non-responders in the primary analysis of the primary estimand.|Cochran-Mantel-Haenszel|The difference in response rates was analysed using the Cochran-Mantel-Haenszel test stratified by baseline disease severity (moderate or severe).||||25.7|-0.2|0.057
72444978|NCT04083235|144404725|OTHER||Hazard Ratio (HR)|0.83||||0.04|TWO_SIDED|95.0|0.7|0.99|||Stratified log-rank test||The HR and 95% confidence interval (CI) was based on a stratified Cox proportional hazards regression model, stratified by baseline Eastern Cooperative Oncology Group (ECOG) performance status, region and liver metastases as per IWRS.|||0.99|0.70|0.04
72444979|NCT04083235|144404726|OTHER||Hazard Ratio (HR)|0.69|||<|0.0001|TWO_SIDED|95.0|0.58|0.83|||Stratified log-rank test||The HR and 95% CI was based on a stratified Cox proportional hazards regression model, stratified by baseline ECOG performance status, region and liver metastases as per IWRS.|||0.83|0.58|<0.0001
72444980|NCT04083235|144404727|OTHER||Odds Ratio (OR)|1.26||||0.11|TWO_SIDED|95.0|0.95|1.69|||Cochran-Mantel-Haenszel||OR, 95% CI and p-value were obtained from the Cochran-Mantel-Haenszel test adjusting by baseline ECOG performance status, region and liver metastases as per IWRS.|||1.69|0.95|0.11
72444981|NCT03958955|144404728|SUPERIORITY||Attributable risk|-0.14||||0.4531|TWO_SIDED|95.0|-0.37|0.09||Exact p-value of McNemar's test.|McNemar||Attributable risk is defined as the difference in estimated probability of treatment success of delgocitinib compared to vehicle. Exact p-value of McNemar's test. Success is defined as having an IGA score of 0 (clear) or 1 (almost clear) at Week 6.|||0.09|-0.37|0.4531
72444982|NCT03958955|144404731|SUPERIORITY||Attributable risk|0.07||||0.5|TWO_SIDED|95.0|-0.02|0.17||Exact p-value of McNemar's test.|McNemar||Attributable risk is defined as the difference in estimated probability of treatment success (i.e. no lesion-specific treatment-related AEs) of delgocitinib compared to vehicle. Exact p-value of McNemar's test.|||0.17|-0.02|0.5000
72444983|NCT03958955|144404732|SUPERIORITY||Attributable risk|-0.14||||0.4531|TWO_SIDED|95.0|-0.37|0.09||Exact p-value of McNemar's test.|McNemar||Attributable risk is defined as the difference in estimated probability of treatment success of delgocitinib vs vehicle. Exact p-value of McNemar's test. Success is defined as having at least a 2-point reduction in IGA score from baseline to Week 6.|||0.09|-0.37|0.4531
72497407|NCT01583374|144524806|SUPERIORITY||LS Mean Difference|0.03||||0.5938|TWO_SIDED|95.0|-0.08|0.14|||ANCOVA|Based on an ANCOVA model for change from baseline with treatment group, CRP and baseline BASDAI score as factors and baseline value as covariate.||||0.14|-0.08|0.5938
72444984|NCT03958955|144404733|SUPERIORITY||Attributable risk|0.0||||1|TWO_SIDED|95.0|-0.22|0.22||Exact p-value of McNemar's test.|McNemar||||Attributable risk is defined as the difference in estimated probability of treatment success of delgocitinib compared to vehicle. Exact p-value of McNemar's test. Success is defined as having at least a 2-point reduction in IGA score from baseline to Week 6.|0.22|-0.22|1.0000
72560584|NCT02004691|144651600|SUPERIORITY||Least Squares Mean Difference|-39.927|STANDARD_ERROR_OF_MEAN|3.4957|<|0.0001|TWO_SIDED|95.0|-47.051|-32.803||Threshold for significance was 0.05.|Mixed model for repeated measures||The 95% CI and p-values were based on a mixed model for repeated measures approach with Baseline Spleen Volume (MN), Baseline age, treatment group, study visit, and study visit by treatment group interaction as covariates.|||-32.803|-47.051|<.0001
72444985|NCT03958955|144404734|SUPERIORITY|||||||0.5797||||||P-value of the Wilcoxon signed rank test.|Wilcoxon signed rank test|Erythema is scored as 0=absent, 1=pink, faint, 2=red, 3=dark red, purple/violaceous/crusted/haemorrhagic. P-value of the Wilcoxon signed rank test.||||||0.5797
72444986|NCT03958955|144404735|SUPERIORITY|||||||0.7862||||||P-value of the Wilcoxon signed rank test.|Wilcoxon signed rank test|P-value of the Wilcoxon signed rank test.||Total skin disease activity score is the sum of the scores for erythema, scaling/hyperkeratosis, and oedema/infiltration. Total skin disease activity score ranges from 0 to 7 with lower score indicating better state.||||0.7862
72444987|NCT04638829|144404737|OTHER|||||||0.0001|||||||t-test, 2 sided|||||||0.0001
72444988|NCT04638829|144404738|OTHER|||||||0.0093|||||||t-test, 2 sided|||||||0.0093
72444989|NCT04638829|144404739|OTHER|||||||0.0003|||||||t-test, 2 sided|||||||0.0003
72444990|NCT04638829|144404740|OTHER||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
72444991|NCT02807636|144404763|SUPERIORITY||Hazard Ratio (HR)|0.82||||0.0073|TWO_SIDED|95.0|0.7|0.96||inverse normal combination|Log Rank|||Stratification factors: Enrollment stage, PD-L1 status, Bajorin risk score/presence of liver metastases, and investigator choice of chemotherapy.||0.96|0.70|0.0073
72444992|NCT02807636|144404764|SUPERIORITY||Hazard Ratio (HR)|0.85||||0.023|TWO_SIDED|95.0|0.73|1.0||one-sided, inverse normal combination|Regression, Cox|||Stratification factors: Enrollment stage, PD-L1 status, Bajorin risk score/presence of liver metastases, and investigator choice of chemotherapy.||1.0|0.73|0.0230
72444993|NCT02807636|144404765|SUPERIORITY||Hazard Ratio (HR)|0.98||||0.3968|TWO_SIDED|95.0|0.82|1.16|||Log Rank|one-sided||Stratification factors: PD-L1 status, Bajorin risk score/presence of liver metastases, and investigator choice of chemotherapy.||1.16|0.82|0.3968
72444994|NCT02807636|144404770|SUPERIORITY||Hazard Ratio (HR)|0.86||||0.0373|TWO_SIDED|95.0|0.73|1.01||inverse normal combination|Regression, Cox|||Stratification factors: Enrollment stage, PD-L1 status, Bajorin risk score/presence of liver metastases, and investigator choice of chemotherapy.||1.01|0.73|0.0373
72444995|NCT02807636|144404771|SUPERIORITY||Difference in Event Free Rate|5.0||||0.1509|TWO_SIDED|95.0|-1.82|11.81|||Z-test|||Stratification factors: Enrollment stage, PD-L1 status, Bajorin risk score/presence of liver metastases, and investigator choice of chemotherapy.||11.81|-1.82|0.1509
72444996|NCT02807636|144404772|SUPERIORITY||Difference in Event Free Rate|3.36||||0.3761|TWO_SIDED|95.0|-4.08|10.79|||Z-test|||Stratification factors: Enrollment stage, PD-L1 status, Bajorin risk score/presence of liver metastases, and investigator choice of chemotherapy.||10.79|-4.08|0.3761
72444997|NCT02807636|144404773|SUPERIORITY||Difference in Event Free Rate|-8.29||||0.0083|TWO_SIDED|95.0|-14.45|-2.13|||Z-test|||Stratification factors: Enrollment stage, PD-L1 status, Bajorin risk score/presence of liver metastases, and investigator choice of chemotherapy.||-2.13|-14.45|0.0083
72444998|NCT02807636|144404774|SUPERIORITY||Hazard Ratio (HR)|0.8||||0.0542|TWO_SIDED|95.0|0.64|1.0|||Log Rank|||Strata are: Enrollment Stage, PD-L1 Status, BAJORIN Risk Factor Score and Stratum 4 for all participants.||1.00|0.64|0.0542
72444999|NCT02807636|144404775|SUPERIORITY||Hazard Ratio (HR)|0.94||||0.6139|TWO_SIDED|95.0|0.74|1.19|||Log Rank|||Strata are: PD-L1 Status, BAJORIN Risk Factor Score and Stratum 4 for all participants.||1.19|0.74|0.6139
72445000|NCT02807636|144404776|SUPERIORITY||Hazard Ratio (HR)|1.07||||0.554|TWO_SIDED|95.0|0.86|1.32|||Log Rank|||Strata are: Enrollment Stage, PD-L1 Status, BAJORIN Risk Factor Score and Stratum 4 for all participants.||1.32|0.86|0.5540
72445001|NCT02807636|144404777|SUPERIORITY||Hazard Ratio (HR)|1.29||||0.0241|TWO_SIDED|95.0|1.03|1.62|||Log Rank|||Strata are: Enrollment Stage, PD-L1 Status, BAJORIN Risk Factor Score and Stratum 4 for all participants.||1.62|1.03|0.0241
72445002|NCT02807636|144404781|SUPERIORITY||Hazard Ratio (HR)|1.42||||1|TWO_SIDED|95.0|1.19|1.69|||Log Rank|||Stratification factors: PD-L1 status and Bajorin risk score/presence of liver metastases and investigator choice of chemotherapy.||1.69|1.19|1.0000
72445003|NCT04088630|144404791|SUPERIORITY|||||||0.0427||||||p\<0.05 considered significant. Between group pairwise comparisons performed with Bonferroni correction.|Fisher Exact|||Difference in proportion of subjects with cardiac events up to 30 days post-ictus tested between three groups.||||0.0427
72445004|NCT04088630|144404792|SUPERIORITY|||||||0.19|||||||Fisher Exact|||Difference in proportion of subjects with nosocomial infections up to 90 days post-ictus tested between three groups. No pairwise comparisons performed.||||0.19
72445005|NCT04088630|144404793|SUPERIORITY|||||||0.3|||||||Fisher Exact|||Difference in proportion of subjects with neurologic decline up to 30 days post-ictus tested between three groups. No pairwise comparisons performed.||||0.30
72445006|NCT03381261|144404830|OTHER|While descriptive statistics were presented in the original mRNA units using median and interquartile range (25th, 75th), statistical group comparison and effect sizes were reported as the ratio of the geometric means.|||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
72445007|NCT05634226|144404831|SUPERIORITY|||||||0.1|||||||t-test, 2 sided|||||||0.1
72445008|NCT05634226|144404832|SUPERIORITY|||||||0.06|||||||t-test, 2 sided|||||||0.06
72497408|NCT01265524|144524811|NON_INFERIORITY_OR_EQUIVALENCE|The efficacy and the safety analyses were done using the ITT population with Week 8/EOS data for the patients who did not complete the 8-week treatment period excluded. The ITT population included all randomized patients who received at least 1 dose of study drug.||||||0.014|TWO_SIDED|95.0||||Corrections for multiplicity were not performed and P values \< 0.05 were considered statistically significant.|ANCOVA|Continuous or ordinal data were analyzed using RM-ANCOVA using change from baseline values to compare CLP and placebo treatments.||||||0.014
72622393|NCT02702999|144774685|SUPERIORITY||Risk Ratio (RR)|3.9|||||TWO_SIDED|95.0|0.9|18.0|||||The intervention arm and control arm were compared using a log binomial (or Poisson in case of nonconvergence) model with the intervention arm as a covariate to estimate relative risk and 95% confidence interval (CI).|||18.0|0.9|
72445009|NCT03761537|144404838|SUPERIORITY|The null hypothesis of no difference between Tralokinumab+TCS and placebo+TCS was tested at a 5% significance level against the 2-sided alternative that there was a difference.|Risk Difference (RD)|14.1||||0.018|TWO_SIDED|95.0|2.5|25.7||This endpoint was the first endpoint in the sequential testing hierarchy.|Mantel Haenszel|Mantel-Haenszel (MH) test stratified by prior CSA use and baseline disease severity. MH risk differences and standard errors combined by Rubin's rule.||Subjects who received rescue treatment or permanently discontinued IMP, without prior subject-onset of the COVID-19 pandemic (SOC19), were considered non-responders after the relevant event occurred. Any data from subjects who had SOC19 as their first prior intercurrent event (ICE) were multiple imputed (MI) assuming missing at random (MAR) following start of SOC19. Data missing prior to any ICE were handled as non-response, except data missing due to the pandemic, which was MI assuming MAR.||25.7|2.5|0.018
72445010|NCT03761537|144404839|SUPERIORITY|The null hypothesis of no difference between Tralokinumab+TCS and placebo+TCS was tested at a 5% significance level against the 2-sided alternative that there was a difference.|Risk Difference (RD)|9.7||||0.106|TWO_SIDED|95.0|-2.0|21.4||This endpoint was the second endpoint in the sequential testing hierarchy. Acceptance of this endpoint depends on prior endpoints' acceptance.|Mantel Haenszel|Mantel-Haenszel (MH) test stratified by prior CSA use and baseline disease severity. MH risk differences and standard errors combined by Rubin's rule.||Subjects who received rescue treatment or permanently discontinued IMP, without prior subject-onset of the COVID-19 pandemic (SOC19), were considered non-responders after the relevant event occurred. Any data from subjects who had SOC19 as their first prior intercurrent event (ICE) were multiple imputed (MI) assuming missing at random (MAR) following start of SOC19. Data missing prior to any ICE were handled as non-response, except data missing due to the pandemic, which was MI assuming MAR.||21.4|-2.0|0.106
72445011|NCT03761537|144404840|SUPERIORITY|The null hypothesis of no difference between Tralokinumab+TCS and placebo+TCS was tested at a 5% significance level against the 2-sided alternative that there was a difference.|Difference|-8.6|||<|0.001|TWO_SIDED|95.0|-13.0|-4.2||This was the third endpoint in the sequential testing hierarchy. Acceptance of this endpoint depends on prior endpoints' acceptance.|Repeated measurements model|Treatment effect at each visit adjusted for baseline SCORAD interacting with each visit, prior CSA, and baseline disease severity (IGA 3 or 4).||Data collected after permanent discontinuation of IMP, after initiation of rescue treatment, or after subject-onset of the COVID-19 pandemic will not be included in the analysis.||-4.2|-13.0|<0.001
72445012|NCT03761537|144404841|SUPERIORITY|The null hypothesis of no difference between Tralokinumab+TCS and placebo+TCS was tested at a 5% significance level against the 2-sided alternative that there was a difference.|Difference|-1.5||||0.009|TWO_SIDED|95.0|-2.6|-0.4||This was the fourth endpoint in the sequential testing hierarchy. Acceptance of this endpoint depends on prior endpoints' acceptance.|Repeated measurements model|Treatment effect at each visit adjusted for baseline DLQI interacting with each visit, prior CSA, and baseline disease severity (IGA 3 or 4).||Data collected after permanent discontinuation of IMP, after initiation of rescue treatment, or after subject-onset of the COVID-19 pandemic will not be included in the analysis.||-0.4|-2.6|0.009
72445013|NCT03761537|144404842|SUPERIORITY|The null hypothesis of no difference between Tralokinumab+TCS and placebo+TCS was tested at a 5% significance level against the 2-sided alternative that there was a difference.|Risk Difference (RD)|15.6||||0.005|TWO_SIDED|95.0|4.8|26.3||This endpoint was the fifth endpoint in the sequential testing hierarchy. Acceptance of this endpoint depends on prior endpoints' acceptance.|Mantel Haenszel|Mantel-Haenszel (MH) test stratified by prior CSA use and baseline disease severity. MH risk differences and standard errors combined by Rubin's rule.||Subjects who received rescue treatment or permanently discontinued IMP, without prior subject-onset of the COVID-19 pandemic (SOC19), were considered non-responders after the relevant event occurred. Any data from subjects who had SOC19 as their first prior intercurrent event (ICE) were multiple imputed (MI) assuming missing at random (MAR) following start of SOC19. Data missing prior to any ICE were handled as non-response, except data missing due to the pandemic, which was MI assuming MAR.||26.3|4.8|0.005
72445014|NCT03761537|144404843|SUPERIORITY|The null hypothesis of no difference between Tralokinumab+TCS and placebo+TCS was tested at a 5% significance level against the 2-sided alternative that there was a difference.|Risk Difference (RD)|14.1||||0.014|TWO_SIDED|95.0|2.9|25.3||This endpoint was the sixth endpoint in the sequential testing hierarchy. Acceptance of this endpoint depends on prior endpoints' acceptance.|Mantel Haenszel|Mantel-Haenszel (MH) test stratified by prior CSA use and baseline disease severity. MH risk differences and standard errors combined by Rubin's rule.||Subjects who received rescue treatment or permanently discontinued IMP, without prior subject-onset of the COVID-19 pandemic (SOC19), were considered non-responders after the relevant event occurred. Any data from subjects who had SOC19 as their first prior intercurrent event (ICE) were multiple imputed (MI) assuming missing at random (MAR) following start of SOC19. Data missing prior to any ICE were handled as non-response, except data missing due to the pandemic, which was MI assuming MAR.||25.3|2.9|0.014
72497409|NCT01265524|144524815|NON_INFERIORITY_OR_EQUIVALENCE|The efficacy and the safety analyses were done using the ITT population with Week 8/EOS data for the patients who did not complete the 8-week treatment period excluded. The ITT population included all randomized patients who received at least 1 dose of study drug.||||||0.0002|TWO_SIDED|95.0||||Corrections for multiplicity were not performed and P values \< 0.05 were considered statistically significant.|ANCOVA|Continuous or ordinal data were analyzed using RM-ANCOVA using change from baseline values to compare CLP and placebo treatments.||||||0.0002
72497410|NCT01265524|144524816|NON_INFERIORITY_OR_EQUIVALENCE|The efficacy and the safety analyses were done using the ITT population with Week 8/EOS data for the patients who did not complete the 8-week treatment period excluded. The ITT population included all randomized patients who received at least 1 dose of study drug.||||||0.072|TWO_SIDED|95.0||||Corrections for multiplicity were not performed and P values \< 0.05 were considered statistically significant.|ANCOVA|Continuous or ordinal data were analyzed using RM-ANCOVA using change from baseline values to compare CLP and placebo treatments.||||||0.072
72497411|NCT02863068|144524835|SUPERIORITY|||||||0.2967||||||A matched pairs design was employed to test for changes in methemoglobin at baseline and EOS for all participants between treatment arms using a Wilcoxon signed rank test|Wilcoxon (Mann-Whitney)|||Change in methemoglobin from baseline to end of study (EOS) for all participants.||||0.2967
72560585|NCT02004691|144651602|SUPERIORITY||Least Squares Mean Difference|1.618|STANDARD_ERROR_OF_MEAN|3.3877|=|0.6364|TWO_SIDED|95.0|-5.302|8.538||Threshold for significance was 0.15.|Mixed model for repeated measures||The 95% CI and p-values are based on a mixed model for repeated measures approach with Baseline Splenomegaly Related Score, Baseline age, treatment group, study visit, and study visit by treatment group interaction as covariates.|||8.538|-5.302|=0.6364
72560586|NCT02004691|144651607|SUPERIORITY||Least Squares Mean Difference|-26.596|STANDARD_ERROR_OF_MEAN|3.5862|<|0.0001|TWO_SIDED|95.0|-33.911|-19.281||Threshold for significance was 0.05.|Mixed model for repeated measures||The 95% CI and p-values are based on a mixed model for repeated measures approach with Baseline Liver Volume (MN), Baseline age, treatment group, study visit, and study visit by treatment group interaction as covariates.|A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in an order the outcome measure were reported and continued when previous endpoint was statistically significant at two-sided 0.05.||-19.281|-33.911|<.0001
72622394|NCT02702999|144774686|SUPERIORITY||Risk Ratio (RR)|1.9|||||TWO_SIDED|95.0|0.4|10.5|||||The intervention arm and control arm were compared using a log binomial (or Poisson in case of nonconvergence) model with the intervention arm as a covariate to estimate relative risk and 95% confidence interval (CI).|||10.5|0.4|
72445015|NCT03761537|144404844|SUPERIORITY|The null hypothesis of no difference between Tralokinumab+TCS and placebo+TCS was tested at a 5% significance level against the 2-sided alternative that there was a difference.|Risk Difference (RD)|7.3||||0.228|TWO_SIDED|95.0|-4.6|19.2||This endpoint was the seventh endpoint in the sequential testing hierarchy. Acceptance of this endpoint depends on prior endpoints' acceptance.|Mantel Haenszel|HaenszMantelel (MH) test stratified by prior CSA use and baseline disease severity. MH risk differences and standard errors combined by Rubin's rule.||Subjects who received rescue treatment or permanently discontinued IMP, without prior subject-onset of the COVID-19 pandemic (SOC19), were considered non-responders after the relevant event occurred. Any data from subjects who had SOC19 as their first prior intercurrent event (ICE) were multiple imputed (MI) assuming missing at random (MAR) following start of SOC19. Data missing prior to any ICE were handled as non-response, except data missing due to the pandemic, which was MI assuming MAR.||19.2|-4.6|0.228
72445016|NCT03761537|144404845|SUPERIORITY|The null hypothesis of no difference between Tralokinumab+TCS and placebo+TCS was tested at a 5% significance level against the 2-sided alternative that there was a difference.|Difference|-8.9|||<|0.001|TWO_SIDED|95.0|-13.2|-4.6||This endpoint was the eighth endpoint in the sequential testing hierarchy. Acceptance of this endpoint depends on prior endpoints' acceptance.|Repeated measurements model|Unstructured covariance matrix. Adjusted for baseline SCORAD in interaction with each visit, prior CSA use, and baseline disease severity (IGA 3 or 4)||Data collected after permanent discontinuation of IMP, after initiation of rescue treatment, or after subject-onset of the COVID-19 pandemic will not be included in the analysis.||-4.6|-13.2|<0.001
72445017|NCT03761537|144404846|SUPERIORITY|The null hypothesis of no difference between Tralokinumab+TCS and placebo+TCS was tested at a 5% significance level against the 2-sided alternative that there was a difference.|Difference|-1.6||||0.005|TWO_SIDED|95.0|-2.7|-0.5||This endpoint was the ninth endpoint in the sequential testing hierarchy. Acceptance of this endpoint depends on prior endpoints' acceptance.|Repeated measurements model|Unstructured covariance matrix. Adjusted for baseline DLQI in interaction with each visit, prior CSA use, and baseline disease severity (IGA 3 or 4)||Data collected after permanent discontinuation of IMP, after initiation of rescue treatment, or after subject-onset of the COVID-19 pandemic will not be included in the analysis.||-0.5|-2.7|0.005
72445018|NCT03761537|144404847|SUPERIORITY|The null hypothesis of no difference between Tralokinumab+TCS and placebo+TCS was tested at a 5% significance level against the 2-sided alternative that there was a difference.|Risk Difference (RD)|14.3||||0.014|TWO_SIDED|95.0|2.9|25.6||This endpoint was the tenth endpoint in the sequential testing hierarchy. Acceptance of this endpoint depends on prior endpoints' acceptance.|Mantel Haenszel|Mantel-Haenszel (MH) test stratified by prior CSA use and baseline disease severity. MH risk differences and standard errors combined by Rubin's rule.||Subjects who received rescue treatment or permanently discontinued IMP, without prior subject-onset of the COVID-19 pandemic (SOC19), were considered non-responders after the relevant event occurred. Any data from subjects who had SOC19 as their first prior intercurrent event (ICE) were multiple imputed (MI) assuming missing at random (MAR) following start of SOC19. Data missing prior to any ICE were handled as non-response, except data missing due to the pandemic, which was MI assuming MAR.||25.6|2.9|0.014
72445019|NCT05493423|144404850|NON_INFERIORITY|The null hypothesis is that the difference between the rates of completed hemodialysis sessions for the test and control groups is less than or equal to the non-inferiority margin (indicating inferior success rate). Rejection of the null hypothesis indicates the data supports the alternative hypothesis that the difference between the rates of successfully completed HD sessions for the test and control groups is at least the non-inferiority margin (indicating non-inferior success rate).||||||0.008|||||||Farrington-Manning|non-inferiority margin = 0.08||||||.008
72445020|NCT05493423|144404850|EQUIVALENCE|non-inferiority margin = 0.08||||||0.002|||||||Equivalence Test with paired data|||||||.002
72445021|NCT05493423|144404851|SUPERIORITY|||||||0||||||The p-value was calculated, but was low enough to be rounded down to 0 by the statistical software.|t-test, 2 sided|||||||0
72497412|NCT02863068|144524836|SUPERIORITY|||||||0.2818||||||A matched pairs design was employed to test for changes in total ulcerated surface area at baseline and EOS between treatment arms using a Wilcoxon signed rank test|Wilcoxon (Mann-Whitney)|||Change in total ulcerated surface area from baseline to end of study (EOS)||||0.2818
72445022|NCT05493423|144404852|SUPERIORITY|||||||0.84||||||P \< 0.05 is considered significant|t-test, 2 sided|||||||0.84
72445023|NCT05493423|144404853|SUPERIORITY|||||||0.132|||||||t-test, 2 sided|||||||0.132
72445024|NCT05493423|144404854|SUPERIORITY|||||||0.84||||||P \< 0.05 is considered significant|t-test, 2 sided|||||||0.84
72445025|NCT05493423|144404855|SUPERIORITY|||||||0.197||||||P \< 0.05 is considered significant|t-test, 2 sided|||||||0.197
72497413|NCT02863068|144524836|SUPERIORITY|||||||1|||||||Fisher Exact|Fisher's exact test was used to test for differences in frequencies between treatment arms||Difference in frequency of 25% total ulcerated surface area reduction between treatment arms||||1.0
72445026|NCT05493423|144404856|SUPERIORITY|||||||0.424|||||||t-test, 2 sided|||||||0.424
72445027|NCT05493423|144404857|SUPERIORITY|||||||0||||||The p-value was calculated, but was low enough to be rounded down to 0 by the statistical software.|t-test, 2 sided|||||||0
72445028|NCT05493423|144404858|SUPERIORITY|||||||0||||||The p-value was calculated, but was low enough to be rounded down to as 0 by the statistical software.|t-test, 2 sided|||||||0
72445029|NCT05493423|144404859|SUPERIORITY|||||||0.57||||||P \< 0.05 is considered significant|t-test, 2 sided|||||||0.57
72445030|NCT05493423|144404860|SUPERIORITY|||||||0||||||The p-value was calculated, but was low enough to be rounded down to 0 by the statistical software.|t-test, 2 sided|||||||0
72445031|NCT05493423|144404861|SUPERIORITY|||||||0.211|||||||t-test, 2 sided|||||||0.211
72389436|NCT01153347|144286736|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.93|STANDARD_ERROR_OF_MEAN|0.39||0.864|TWO_SIDED|95.0|0.41|2.14|||Regression, Logistic||TC-5214 is the numerator in the OR, OR\>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization MADRS total score as a covariate.||2.14|0.41|0.864
72389437|NCT01153347|144286736|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.98|STANDARD_ERROR_OF_MEAN|0.42||0.958|TWO_SIDED|95.0|0.43|2.25|||Regression, Logistic||TC-5214 is the numerator in the OR, OR\>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization MADRS total score as a covariate.||2.25|0.43|0.958
72389438|NCT01153347|144286737|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.91|STANDARD_ERROR_OF_MEAN|0.3||0.778|TWO_SIDED|95.0|0.48|1.73|||Regression, Logistic||TC-5214 is the numerator in the OR, OR\>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization MADRS total score as a covariate.||1.73|0.48|0.778
72389439|NCT01153347|144286737|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.22|STANDARD_ERROR_OF_MEAN|0.38||0.532|TWO_SIDED|95.0|0.66|2.24|||Regression, Logistic||TC-5214 is the numerator in the OR, OR\>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization MADRS total score as a covariate.||2.24|0.66|0.532
72389440|NCT01153347|144286737|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.85|STANDARD_ERROR_OF_MEAN|0.29||0.633|TWO_SIDED|95.0|0.44|1.64|||Regression, Logistic||TC-5214 is the numerator in the OR, OR\>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization MADRS total score as a covariate.||1.64|0.44|0.633
72389441|NCT01153347|144286738|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.03|STANDARD_ERROR_OF_MEAN|0.42||0.949|TWO_SIDED|95.0|0.46|2.31|||Regression, Logistic||TC-5214 is the numerator in the OR, OR\>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization MADRS total score as a covariate.||2.31|0.46|0.949
72389442|NCT01153347|144286738|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.57|STANDARD_ERROR_OF_MEAN|0.62||0.253|TWO_SIDED|95.0|0.72|3.4|||Regression, Logistic||TC-5214 is the numerator in the OR, OR\>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization MADRS total score as a covariate.||3.40|0.72|0.253
72389443|NCT01153347|144286738|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.88|STANDARD_ERROR_OF_MEAN|0.39||0.763|TWO_SIDED|95.0|0.37|2.08|||Regression, Logistic||TC-5214 is the numerator in the OR, OR\>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization MADRS total score as a covariate.||2.08|0.37|0.763
72389444|NCT01153347|144286739|SUPERIORITY_OR_OTHER||LS mean|-1.0|STANDARD_ERROR_OF_MEAN|0.78||0.207|TWO_SIDED|95.0|-2.51|0.55|||ANCOVA|||Analysis of covariance (ANCOVA) with randomization HAMD-17 total score as covariate, treatment as a fixed effect and pooled center as a random effect.||0.55|-2.51|0.207
72389445|NCT01153347|144286739|SUPERIORITY_OR_OTHER||LS mean|-0.6|STANDARD_ERROR_OF_MEAN|0.78||0.427|TWO_SIDED|95.0|-2.16|0.91|||ANCOVA|||Analysis of covariance (ANCOVA) with randomization HAMD-17 total score as covariate, treatment as a fixed effect and pooled center as a random effect.||0.91|-2.16|0.427
72389446|NCT01153347|144286739|SUPERIORITY_OR_OTHER||LS mean|-0.4|STANDARD_ERROR_OF_MEAN|0.78||0.591|TWO_SIDED|95.0|-1.96|1.12|||ANCOVA|||Analysis of covariance (ANCOVA) with randomization HAMD-17 total score as covariate, treatment as a fixed effect and pooled center as a random effect.||1.12|-1.96|0.591
72389447|NCT01153347|144286740|SUPERIORITY_OR_OTHER||LS mean|-0.1|STANDARD_ERROR_OF_MEAN|0.13||0.551||95.0|-0.34|0.18|||MMRM|||MMRM model includes treatment, pooled center, visit, and treatment by visit interaction as explanatory variables and the randomization CGI-S total score as a covariate. Treatment, visit, and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||0.18|-0.34|0.551
72389448|NCT01153347|144286740|SUPERIORITY_OR_OTHER||LS mean|-0.1|STANDARD_ERROR_OF_MEAN|0.13||0.487|TWO_SIDED|95.0|-0.36|0.17|||MMRM|||MMRM model includes treatment, pooled center, visit, and treatment by visit interaction as explanatory variables and the randomization CGI-S total score as a covariate. Treatment, visit, and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||0.17|-0.36|0.487
72389449|NCT01153347|144286740|SUPERIORITY_OR_OTHER||LS mean|0.0|STANDARD_ERROR_OF_MEAN|0.14||0.78|TWO_SIDED|95.0|-0.23|0.31|||MMRM|||MMRM model includes treatment, pooled center, visit, and treatment by visit interaction as explanatory variables and the randomization CGI-S total score as a covariate. Treatment, visit, and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||0.31|-0.23|0.780
72445032|NCT05493423|144404862|SUPERIORITY|||||||0.804||||||P \< 0.05 is considered significant|t-test, 2 sided|||||||0.804
72445033|NCT05493423|144404863|SUPERIORITY|||||||0.307||||||P \< 0.05 is considered significant|t-test, 2 sided|||||||0.307
72445034|NCT05493423|144404864|SUPERIORITY|||||||0.315||||||P \< 0.05 is considered significant|t-test, 2 sided|||||||0.315
72445035|NCT01426425|144404878|SUPERIORITY_OR_OTHER_LEGACY||Chronic effectiveness prob at 6 months|0.926|||<|0.0001|TWO_SIDED|95.0|0.895|0.948|||Kaplan-Meier log-log 95% CI||The chronic effectiveness success probability at 6 months was estimated using the Kaplan-Meier method. The standard error was approximated using Greenwood's formula. A two-sided 95% log-log confidence interval for the probability was constructed.|"The following hypothesis was tested at a one-sided 0.025 significance level.~Ho: PE ≤ 0.83~Ha: PE \> 0.83~Where PE is the probability of a subject achieving chronic effectiveness success at the 6-month follow-up and 0.83 (83%) is the pre-specified performance goal."||0.948|0.895|<0.0001
72560587|NCT02004691|144651608|SUPERIORITY||Least Squares Mean Difference|14.332|STANDARD_ERROR_OF_MEAN|5.7822|=|0.0185|TWO_SIDED|95.0|2.564|26.099||Threshold for significance was 0.05.|Mixed model for repeated measures||The 95% CI and p-values are based on a mixed model for repeated measures approach with Baseline Platelets, Baseline age, treatment group, study visit, and study visit by treatment group interaction as covariates.|A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in an order the outcome measure were reported and continued when previous endpoint was statistically significant at two-sided 0.05.||26.099|2.564|=0.0185
72560588|NCT02004691|144651609|SUPERIORITY||Least Squares Mean Difference|-0.056|STANDARD_ERROR_OF_MEAN|0.7384|=|0.94|TWO_SIDED|95.0|-1.566|1.454||Threshold for significance was 0.05.|Mixed model for repeated measures||The 95% CI and p-values are based on a mixed model for repeated measures approach with Baseline BFI item 3 (Worst Fatigue), Baseline age, treatment group, study visit, and study visit by treatment group interaction as covariates.|A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in an order the outcome measure were reported and continued when previous endpoint was statistically significant at two-sided 0.05.||1.454|-1.566|=0.9400
72560589|NCT01320722|144651624|SUPERIORITY|||||||0.72|||||||Repeated Measures Analysis|||Week 8||||0.72
72560590|NCT01320722|144651625|SUPERIORITY|||||||0.77||||||Statistical significance was set for P\>0.05.|t-test, 2 sided|||Week 8||||0.77
72560591|NCT01320722|144651626|SUPERIORITY|||||||0.57||||||Statistical significance was set for P\>0.05.|t-test, 2 sided|||Week 8||||0.57
72560592|NCT01320722|144651627|SUPERIORITY|||||||0.8|||||||Repeated Measures Analysis|||||||0.8
72560593|NCT01320722|144651627|SUPERIORITY|||||||0.6|||||||Repeated Measures Analysis|||||||0.6
72560594|NCT01320722|144651628|SUPERIORITY|||||||0.6|||||||Repeated Measures Analysis|||||||0.6
72560595|NCT01320722|144651628|SUPERIORITY|||||||0.7|||||||Repeated Measures Analysis|||||||0.7
72560596|NCT01320722|144651629|SUPERIORITY|||||||0.3|||||||Repeated Measures Analysis|||||||0.3
72389450|NCT01153347|144286741|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.97|STANDARD_ERROR_OF_MEAN|0.23||0.908|TWO_SIDED|95.0|0.62|1.53|||Regression, Logistic||TC-5214 is the numerator in the OR, OR\>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization Clinical Global Impression Severity (CGI-S) as a covariate.||1.53|0.62|0.908
72389451|NCT01153347|144286741|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.06|STANDARD_ERROR_OF_MEAN|0.24||0.803|TWO_SIDED|95.0|0.67|1.67|||Regression, Logistic||TC-5214 is the numerator in the OR, OR\>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization Clinical Global Impression Severity (CGI-S) as a covariate.||1.67|0.67|0.803
72389452|NCT01153347|144286741|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.65|STANDARD_ERROR_OF_MEAN|0.15||0.066|TWO_SIDED|95.0|0.41|1.03|||Regression, Logistic||TC-5214 is the numerator in the OR, OR\>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization Clinical Global Impression Severity (CGI-S) as a covariate.||1.03|0.41|0.066
72389453|NCT01153347|144286742|SUPERIORITY_OR_OTHER||LS mean|-0.82|STANDARD_ERROR_OF_MEAN|0.645||0.202|TWO_SIDED|95.0|-2.091|0.442|||ANCOVA|||An analysis of covariance (ANCOVA) with randomization HAM-A total score as covariate, treatment as a fixed effect and pooled center as a random effect.||0.442|-2.091|0.202
72389454|NCT01153347|144286742|SUPERIORITY_OR_OTHER||LS mean|-0.22|STANDARD_ERROR_OF_MEAN|0.647||0.738|TWO_SIDED|95.0|-1.487|1.055|||ANCOVA|||An analysis of covariance (ANCOVA) with randomization HAM-A total score as covariate, treatment as a fixed effect and pooled center as a random effect.||1.055|-1.487|0.738
72389455|NCT01153347|144286742|SUPERIORITY_OR_OTHER||LS mean|-0.51|STANDARD_ERROR_OF_MEAN|0.65||0.433|TWO_SIDED|95.0|-1.787|0.767|||ANCOVA|||An analysis of covariance (ANCOVA) with randomization HAM-A total score as covariate, treatment as a fixed effect and pooled center as a random effect.||0.767|-1.787|0.433
72389456|NCT01153347|144286743|SUPERIORITY_OR_OTHER||LS mean|1.0|STANDARD_ERROR_OF_MEAN|0.61||0.097|TWO_SIDED|95.0|-0.18|2.22|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization MADRS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||2.22|-0.18|0.097
72389457|NCT01153347|144286743|SUPERIORITY_OR_OTHER||LS mean|-0.1|STANDARD_ERROR_OF_MEAN|0.61||0.882|TWO_SIDED|95.0|-1.29|1.11|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization MADRS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||1.11|-1.29|0.882
72389458|NCT01153347|144286743|SUPERIORITY_OR_OTHER||LS mean|1.0|STANDARD_ERROR_OF_MEAN|0.62||0.1|TWO_SIDED|95.0|-0.19|2.23|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization MADRS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||2.23|-0.19|0.100
72389459|NCT01153347|144286744|SUPERIORITY_OR_OTHER||LS mean|0.8|STANDARD_ERROR_OF_MEAN|0.74||0.303|TWO_SIDED|95.0|-0.69|2.22|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization MADRS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||2.22|-0.69|0.303
72389460|NCT01153347|144286744|SUPERIORITY_OR_OTHER||LS mean|0.2|STANDARD_ERROR_OF_MEAN|0.74||0.793|TWO_SIDED|95.0|-1.26|1.65|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization MADRS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||1.65|-1.26|0.793
72389461|NCT01153347|144286744|SUPERIORITY_OR_OTHER||LS mean|-0.2|STANDARD_ERROR_OF_MEAN|0.75||0.762|TWO_SIDED|95.0|-1.7|1.25|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization MADRS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||1.25|-1.70|0.762
72560597|NCT01320722|144651629|SUPERIORITY|||||||0.1|||||||Repeated Measures Analysis|||||||0.1
72560598|NCT01320722|144651630|SUPERIORITY_OR_OTHER|||||||0.35|||||||t-test, 2 sided|Statistical significance was set for a 2-tailed P \<0.05.||Week 8||||0.35
72497414|NCT02863068|144524837|SUPERIORITY|||||||0.3754||||||A matched pairs design was employed to test for changes in average pain at baseline and EOS between treatment arms using a Wilcoxon signed rank test|Wilcoxon (Mann-Whitney)|||Change in average pain from baseline to end of study (EOS)||||0.3754
72497415|NCT02863068|144524839|SUPERIORITY|||||||0.1165||||||A matched pairs design was employed to test for changes in methemoglobin at baseline and EOS between treatment arms for participants on Hydroxyurea (HU) using a Wilcoxon signed rank test.|Wilcoxon (Mann-Whitney)|||Change in methemoglobin from baseline to end of study (EOS) for participants on Hydroxyurea (HU).||||0.1165
72497416|NCT02863068|144524839|SUPERIORITY|||||||0.4583||||||A matched pairs design was employed to test for changes in methemoglobin at baseline and EOS between treatment arms for participants off Hydroxyurea (HU) using a Wilcoxon signed rank test.|Wilcoxon (Mann-Whitney)|||Change in methemoglobin from baseline to end of study (EOS) for participants off Hydroxyurea (HU).||||0.4583
72497417|NCT02863068|144524840|SUPERIORITY|||||||0.068||||||A matched pairs design was employed to test for changes in total ulcerated surface area at baseline and EOS between treatment arms for participants on Hydroxyurea (HU) using a Wilcoxon signed rank test.|Wilcoxon (Mann-Whitney)|||Change in total ulcerated surface area from baseline to end of study (EOS) for participants on Hydroxyurea (HU).||||0.068
72560599|NCT01320722|144651630|SUPERIORITY|||||||0.7||||||Statistical significance was set for a 2-tailed P \<0.05.|t-test, 2 sided|||Week 8||||0.7
72560600|NCT01320722|144651630|SUPERIORITY|||||||0.06||||||Statistical significance was set for a 2-tailed P \<0.05.|t-test, 2 sided|||Week 8||||0.06
72560601|NCT01320722|144651631|SUPERIORITY|||||||0.92||||||Statistical significance was set for P\>0.05.|Repeated Measures Analysis|||Overall SBP||||0.92
72560602|NCT01320722|144651631|SUPERIORITY|||||||0.64||||||Statistical significance was set for P\>0.05.|Repeated Measures Analysis|||Overall DBP||||0.64
72560603|NCT01320722|144651631|SUPERIORITY|||||||0.8||||||Statistical significance was set for P\>0.05.|Repeated Measures Analysis|||Awake SBP||||0.80
72560604|NCT01320722|144651631|SUPERIORITY|||||||0.97||||||Statistical significance was set for P\>0.05.|Repeated Measures Analysis|||Asleep SBP at Week 8||||0.97
72560605|NCT01320722|144651631|SUPERIORITY|||||||0.34|||||||Repeated Measures Analysis|||Overall SBP||||0.34
72560606|NCT01320722|144651631|SUPERIORITY|||||||0.59|||||||Repeated Measures Analysi|||Overall DBP||||0.59
72560607|NCT01320722|144651631|SUPERIORITY|||||||0.57|||||||Repeated Measures Analysis|||Awake SBF||||0.57
72389462|NCT01153347|144286745|SUPERIORITY_OR_OTHER||LS mean|-0.9|STANDARD_ERROR_OF_MEAN|0.91||0.339|TWO_SIDED|95.0|-2.65|0.92|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization MADRS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||0.92|-2.65|0.339
72389463|NCT01153347|144286745|SUPERIORITY_OR_OTHER||LS mean|-0.9|STANDARD_ERROR_OF_MEAN|0.91||0.321|TWO_SIDED|95.0|-2.7|0.89|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization MADRS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||0.89|-2.70|0.321
72389464|NCT01153347|144286745|SUPERIORITY_OR_OTHER||LS mean|-0.4|STANDARD_ERROR_OF_MEAN|0.92||0.68|TWO_SIDED|95.0|-2.2|1.43|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization MADRS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||1.43|-2.20|0.680
72389465|NCT01153347|144286746|SUPERIORITY_OR_OTHER||LS mean|-0.3|STANDARD_ERROR_OF_MEAN|0.97||0.737|TWO_SIDED|95.0|-2.23|1.58|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization MADRS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects the model; pooled center is a random effect.||1.58|-2.23|0.737
72389466|NCT01153347|144286746|SUPERIORITY_OR_OTHER||LS mean|-0.6|STANDARD_ERROR_OF_MEAN|0.98||0.547|TWO_SIDED|95.0|-2.52|1.33|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization MADRS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||1.33|-2.52|0.547
72389467|NCT01153347|144286746|SUPERIORITY_OR_OTHER||LS mean|0.1|STANDARD_ERROR_OF_MEAN|0.99||0.953|TWO_SIDED|95.0|-1.89|2.01|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization MADRS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||2.01|-1.89|0.953
72389468|NCT01153347|144286747|SUPERIORITY_OR_OTHER||LS mean|-0.6|STANDARD_ERROR_OF_MEAN|0.746||1|TWO_SIDED|95.0|-2.069|0.864||The adjusted p-value protects the overall family-wise error rate by taking into account the multiple comparisons between the TC-5214 doses for both the primary efficacy variable (MADRS) and the key secondary efficacy variable (SDS).|MMRM|||MMRM model includes treatment, pooled center, visit, and treatment by visit interaction as explanatory variables and the randomization SDS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||0.864|-2.069|1.000
72497418|NCT02863068|144524840|SUPERIORITY|||||||0.5||||||A matched pairs design was employed to test for changes in total ulcerated surface area at baseline and EOS between treatment arms for participants off Hydroxyurea (HU) using a Wilcoxon signed rank test.|Wilcoxon (Mann-Whitney)|||Change in total ulcerated surface area from baseline to end of study (EOS) for participants off Hydroxyurea (HU).||||0.5
72560608|NCT01320722|144651631|SUPERIORITY|||||||0.08|||||||Repeated Measures Analysis|||Asleep SBP||||0.08
72560609|NCT01320722|144651631|SUPERIORITY|||||||0.59|||||||Repeated Measures Analysis|||Overall SBP||||0.59
72560610|NCT01320722|144651631|SUPERIORITY|||||||0.53|||||||Repeated Measures Analysis|||||||0.53
72560611|NCT01320722|144651631|SUPERIORITY|||||||0.55|||||||Repeated Measures Analysis|||Awake SBP||||0.55
72560612|NCT01320722|144651631|SUPERIORITY|||||||0.8|||||||Repeated Measures Analysis|||Asleep SBP||||0.80
72560613|NCT01320722|144651632|SUPERIORITY|||||||0.98|||||||Repeated Measures Analysis|||||||0.98
72560614|NCT01320722|144651632|SUPERIORITY|||||||0.07|||||||Repeated Measures Analysis|||||||0.07
72560615|NCT01320722|144651632|SUPERIORITY|||||||0.97|||||||Repeated Measures Analysis|||||||0.97
72445036|NCT01426425|144404879|SUPERIORITY_OR_OTHER_LEGACY||Safety failure probability at 6 months|0.01|||<|0.0001|TWO_SIDED|95.0|0.004|0.027|||Kaplan-Meier log-log 95% CI||The chronic safety failure probability at 6 months was estimated using the Kaplan-Meier method. The standard error was approximated using Greenwood's formula. A two-sided 95% log-log confidence interval for the probability was constructed.|"The following hypothesis was tested at a one-sided 0.025 significance level.~Ho: Ps ≥ 0.07~Ha: Ps \< 0.07~Where Ps is the probability of a subject experiencing at least one safety event through 6 months with a 0.07 pre-specified performance goal."||0.027|0.004|<0.0001
72445037|NCT01426425|144404880|SUPERIORITY_OR_OTHER_LEGACY||Chronic effectiveness prob at 6 months|0.973|||<|0.0001|TWO_SIDED|95.0|0.95|0.985|||Kaplan-Meier log-log 95% CI||The chronic effectiveness success probability at 6 months was estimated using the Kaplan-Meier method. The standard error was approximated using Greenwood's formula. A two-sided 95% log-log confidence interval for the probability was constructed.|"The following hypothesis was tested at a one-sided 0.025 significance level.~Ho: PE ≤ 0.80~Ha: PE \> 0.80~Where PE is the probability of a subject achieving chronic effectiveness success at 6-month follow-up, and 0.80 is the pre-specified performance goal. As pre-defined in the study protocol, this hypothesis is tested if the primary effectiveness objective null hypothesis (Ho) is rejected."||0.985|0.950|<0.0001
72445038|NCT03281291|144404887|OTHER||Vaccine Efficacy|29.7|||||TWO_SIDED|95.0|14.7|42.1|||Regression, Cox||VE = 1 minus the Hazard Ratio (HR). HR was defined as the ratio of relative risk of infection in the vaccinated group compared to the control group.|Comparison of vaccine efficacy (VE) in the TVC against the first new genotypic infection, between enrollment and Month 20 visit, for R012-20 Group vs Control Group.||42.1|14.7|
72445039|NCT03281291|144404887|OTHER||Vaccine Efficacy|31.2|||||TWO_SIDED|95.0|16.4|43.3|||Regression, Cox||VE = 1 minus HR. HR was defined as the ratio of relative risk of infection in the vaccinated group compared to the control group.|Comparison of vaccine efficacy in the TVC against the first new genotypic infection, between enrollment and Month 20 visit, for R012-14-mD Group vs Control Group.||43.3|16.4|
72445040|NCT03281291|144404887|OTHER||Vaccine Efficacy|24.6|||||TWO_SIDED|95.0|9.0|37.6|||Regression, Cox||VE = 1 minus HR. HR was defined as the ratio of relative risk of infection in the vaccinated group compared to the control group.|Comparison of vaccine efficacy in the TVC against the first new genotypic infection, between enrollment and Month 20 visit, for Fx012-14-mFxD Group vs Control Group.||37.6|9.0|
72560616|NCT00784095|144651635|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.9||||0.047|TWO_SIDED|95.0|0.04|5.7|||Mixed Models Analysis|||Intervention (Preparation and Completion) versus True Control at 8 weeks||5.7|.04|.047
72560617|NCT00784095|144651635|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.8|||||TWO_SIDED|95.0|-1.1|4.7||||||Intervention (Preparation and Completion) versus Attention Control at 8 weeks||4.7|-1.1|
72560618|NCT00784095|144651636|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.2|||||TWO_SIDED|95.0|-3.2|5.6||||||Intervention (Preparation and Completion) versus True Control at 8 weeks||5.6|-3.2|
72560619|NCT00784095|144651636|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.1|||||TWO_SIDED|95.0|-5.6|3.3||||||Intervention (Preparation and Completion) versus Attention Control at 8 weeks||3.3|-5.6|
72560620|NCT00784095|144651637|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.6|||||TWO_SIDED|95.0|-6.2|2.9||||||Intervention (Preparation and Completion) versus True Control at 8 weeks||2.9|-6.2|
72560621|NCT00784095|144651637|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.6|||||TWO_SIDED|95.0|-8.2|1.0||||||Intervention (Preparation and Completion) versus Attention Control at 8 weeks||1.0|-8.2|
72560622|NCT00784095|144651638|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6|||||TWO_SIDED|95.0|-4.5|3.4||||||Intervention (Preparation and Completion) versus True Control at 8 weeks||3.4|-4.5|
72560623|NCT00784095|144651638|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.1|||||TWO_SIDED|95.0|-5.1|3.0||||||Intervention versus Attention Control at 8 weeks.||3.0|-5.1|
72560624|NCT00784095|144651639|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6|||||TWO_SIDED|95.0|-4.8|3.7||||||Intervention (Preparation and Completion) versus True Control at 8 weeks||3.7|-4.8|
72445041|NCT03281291|144404887|OTHER||Vaccine Efficacy|28.8|||||TWO_SIDED|95.0|13.9|41.1|||Regression, Cox||VE = 1 minus HR. HR was defined as the ratio of relative risk of infection in the vaccinated group compared to the control group.|Comparison of vaccine efficacy in the TVC against the first new genotypic infection, between enrollment and Month 20 visit, for Fx017-mFxD Group vs Control Group.||41.1|13.9|
72445042|NCT03281291|144404888|OTHER||Vaccine Efficacy|42.8|||||TWO_SIDED|95.0|30.7|52.8|||Regression, Cox||VE = 1 minus HR. HR was defined as the ratio of relative risk of infection in the vaccinated group compared to the control group.|Comparison of vaccine efficacy in the ATP cohort against the first new genotypic infection, between months 2.5 and 14, for R012-20 + R012-14-mD Pooled Group vs Control Group.||52.8|30.7|
72560625|NCT00784095|144651639|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.4|||||TWO_SIDED|95.0|-1.9|6.7||||||Intervention (Preparation and Completion) versus Attention Control at 8 weeks.||6.7|-1.9|
72560626|NCT01540045|144651650|SUPERIORITY_OR_OTHER_LEGACY|||||||0.013|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||For the paired analysis of taste acuity we used Wilcoxon for difference between baseline and 6 weeks later.||||0.013
72560627|NCT01540045|144651651|SUPERIORITY_OR_OTHER_LEGACY|||||||0.671|TWO_SIDED||||||t-test, 2 sided|||we evaluated body fat before and after 2 cycles of cisplatin/paclitaxel based chemotheprapy||||0.671
72560628|NCT01540045|144651651|SUPERIORITY_OR_OTHER_LEGACY|||||||0.694|TWO_SIDED||||||t-test, 2 sided|||we evaluated lean body mass before and after 2 cycles of cisplatin/paclitaxel based chemotheprapy||||0.694
72560629|NCT01540045|144651652|SUPERIORITY_OR_OTHER_LEGACY|||||||0.118|TWO_SIDED||||||t-test, 2 sided|||||||0.118
72560630|NCT01540045|144651653|SUPERIORITY_OR_OTHER_LEGACY|||||||0.607|TWO_SIDED||||||McNemar|||Subjective global assessment (PG-SGA) was used to assess and classify patients as having severe or moderate malnourishment (B or C) or as being well nourished (A).||||0.607
72560631|NCT01540045|144651654|SUPERIORITY_OR_OTHER_LEGACY|||||||0.015|TWO_SIDED||||||t-test, 2 sided|||protein consumption was estimated by questionnaire SNUT difference between ≥ Sweet perception thresholds compared to \< Sweet perception thresholds after chemotherapy||||0.015
72560632|NCT01540045|144651654|SUPERIORITY_OR_OTHER_LEGACY|||||||0.01|TWO_SIDED||||||t-test, 2 sided|||animal protein consumption was estimated by questionnaire SNUT difference between ≥ Sweet perception thresholds vs \< Sweet perception thresholds after chemotherapy||||0.010
72389469|NCT01153347|144286747|SUPERIORITY_OR_OTHER||LS mean|-0.52|STANDARD_ERROR_OF_MEAN|0.755||1|TWO_SIDED|95.0|-2.004|0.96||The adjusted p-value protects the overall family-wise error rate by taking into account the multiple comparisons between the TC-5214 doses for both the primary efficacy variable (MADRS) and the key secondary efficacy variable (SDS).|MMRM|||MMRM model includes treatment, pooled center, visit, and treatment by visit interaction as explanatory variables and the randomization SDS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||0.960|-2.004|1.000
72389470|NCT01153347|144286747|SUPERIORITY_OR_OTHER||LS mean|0.4|STANDARD_ERROR_OF_MEAN|0.761||1|TWO_SIDED|95.0|-1.095|1.896||The adjusted p-value protects the overall family-wise error rate by taking into account the multiple comparisons between the TC-5214 doses for both the primary efficacy variable (MADRS) and the key secondary efficacy variable (SDS).|MMRM|||MMRM model includes treatment, pooled center, visit, and treatment by visit interaction as explanatory variables and the randomization SDS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||1.896|-1.095|1.000
72389471|NCT01153347|144286748|SUPERIORITY_OR_OTHER||LS mean|0.0|STANDARD_ERROR_OF_MEAN|0.29||0.953|TWO_SIDED|95.0|-0.56|0.59|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization SDS work/school domain score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||0.59|-0.56|0.953
72445043|NCT03281291|144404888|OTHER||Vaccine Efficacy|36.7|||||TWO_SIDED|95.0|21.2|49.2|||Regression, Cox||VE = 1 minus HR. HR was defined as the ratio of relative risk of infection in the vaccinated group compared to the control group.|Comparison of vaccine efficacy in the ATP cohort against the first new genotypic infection, between months 2.5 and 14, for Fx012-14-mFxD Group vs Control Group.||49.2|21.2|
72445044|NCT03281291|144404888|OTHER||Vaccine Efficacy|41.4|||||TWO_SIDED|95.0|26.7|53.1|||Regression, Cox||VE = 1 minus HR. HR was defined as the ratio of relative risk of infection in the vaccinated group compared to the control group.|Comparison of vaccine efficacy in the ATP cohort against the first new genotypic infection, between months 7.5 and 19, for Fx017-mFxD Group vs Control Group.||53.1|26.7|
72445045|NCT03281291|144404889|OTHER||Vaccine Efficacy|29.6|||||TWO_SIDED|95.0|15.4|41.5|||Regression, Cox||VE = 1 minus HR. HR was defined as the ratio of relative risk of infection in the vaccinated group compared to the control group.|Comparison of vaccine efficacy in the TVC against the first new genotypic infection, between enrollment and Month 32 visit, for R012-20 Group vs Control Group.||41.5|15.4|
72560633|NCT01540045|144651654|SUPERIORITY_OR_OTHER_LEGACY|||||||0.004|TWO_SIDED||||||t-test, 2 sided|||FAT consumption was estimated by questionnaire SNUT difference between ≥ Sweet perception thresholds vs \< Sweet perception thresholds after chemotherapy||||0.004
72560634|NCT01540045|144651656|SUPERIORITY_OR_OTHER_LEGACY|||||||0.28|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||For the paired analysis of taste acuity we used Wilcoxon for difference between baseline and 6 weeks later.||||0.28
72560635|NCT01540045|144651657|SUPERIORITY_OR_OTHER_LEGACY|||||||0.889|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||change in status global of quality of life between ≤ compared to \> umami recognition threshold after chemotherapy by EORT questionnaire||||0.889
72560636|NCT01540045|144651657|SUPERIORITY_OR_OTHER_LEGACY|||||||0.293|TWO_SIDED|||||clinically significant|Wilcoxon (Mann-Whitney)|||change in functional role of quality of life between ≤ compared to \> umami recognition threshold after chemotherapy by EORT questionnaire||||0.293
72560637|NCT01540045|144651657|SUPERIORITY_OR_OTHER_LEGACY|||||||0.009|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||change in emotional functioning of quality of life between ≤ compared to \> umami recognition threshold after chemotherapy by EORT questionnaire||||0.009
72560638|NCT01540045|144651657|SUPERIORITY_OR_OTHER_LEGACY|||||||0.213|TWO_SIDED|||||clinically significant|Wilcoxon (Mann-Whitney)|||change in fatigue scale of quality of life between ≤ compared to \> umami recognition threshold after chemotherapy by EORT questionnaire||||0.213
72560639|NCT01540045|144651657|SUPERIORITY_OR_OTHER_LEGACY|||||||0.595|TWO_SIDED|||||clinically significant|Wilcoxon (Mann-Whitney)|||change in appetite loss of quality of life between ≤ compared to \> umami recognition threshold after chemotherapy by EORT questionnaire||||0.595
72560640|NCT01540045|144651657|SUPERIORITY_OR_OTHER_LEGACY|||||||0.068|TWO_SIDED|||||clinically significant|Wilcoxon (Mann-Whitney)|||change in constipation scale of quality of life between ≤ compared to \> umami recognition threshold after chemotherapy by EORT questionnaire||||0.068
72560641|NCT01540045|144651658|SUPERIORITY_OR_OTHER_LEGACY|||||||0.05|TWO_SIDED||||||t-test, 2 sided|||||||0.05
72560642|NCT01540045|144651659|SUPERIORITY_OR_OTHER_LEGACY|||||||0.24|TWO_SIDED|||||clinically significant|Wilcoxon (Mann-Whitney)|||change in peripheral neuropathy scale of quality of life between \> ó = compared to \< umami recognition threshold after chemotherapy by EORT questionnaire||||0.240
72560643|NCT01540045|144651660|SUPERIORITY_OR_OTHER_LEGACY|||||||0.036|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||change in status global of quality of life between \> ó = compared to \< umami recognition threshold after chemotherapy by EORT questionnaire||||0.036
72560644|NCT01540045|144651661|SUPERIORITY_OR_OTHER_LEGACY|||||||0.312|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||For the paired analysis of taste acuity we used Wilcoxon for difference between baseline and 6 weeks later.||||0.312
72560645|NCT01540045|144651662|SUPERIORITY_OR_OTHER_LEGACY|||||||0.608|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||For the paired analysis of taste acuity we used Wilcoxon for difference between baseline and 6 weeks later.||||0.608
72560646|NCT01540045|144651663|SUPERIORITY_OR_OTHER_LEGACY|||||||0.035|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||For the paired analysis of taste acuity we used Wilcoxon for difference between baseline and 6 weeks later.||||0.035
72560647|NCT01540045|144651664|SUPERIORITY_OR_OTHER_LEGACY|||||||0.402|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||For the paired analysis of taste acuity we used Wilcoxon for difference between baseline and 6 weeks later.||||0.402
72560648|NCT01540045|144651665|SUPERIORITY_OR_OTHER_LEGACY|||||||0.109|TWO_SIDED||||||McNemar|||for the paired analysis of taste acuity, we used Mc Nemar test for dividing into high and low sensibility to umami, bitter and sweet tastes.||||0.109
72560649|NCT01540045|144651666|SUPERIORITY_OR_OTHER_LEGACY|||||||0.092|TWO_SIDED||||||McNemar|||for the paired analysis of taste acuity, we used Mc Nemar test for dividing into high and low sensibility to umami, bitter and sweet tastes.||||0.092
72445046|NCT03281291|144404889|OTHER||Vaccine Efficacy|30.6|||||TWO_SIDED|95.0|16.6|42.2|||Regression, Cox||VE = 1 minus HR. HR was defined as the ratio of relative risk of infection in the vaccinated group compared to the control group.|Comparison of vaccine efficacy in the TVC against the first new genotypic infection, between enrollment and Month 32 visit, for R012-14-mD Group vs Control Group.||42.2|16.6|
72445047|NCT03281291|144404889|OTHER||Vaccine Efficacy|27.4|||||TWO_SIDED|95.0|13.1|39.4|||Regression, Cox||VE = 1 minus HR. HR was defined as the ratio of relative risk of infection in the vaccinated group compared to the control group.|Comparison of vaccine efficacy in the TVC against the first new genotypic infection, between enrollment and Month 32 visit, for Fx012-14-mFxD Group vs Control Group.||39.4|13.1|
72445048|NCT03281291|144404889|OTHER||Vaccine Efficacy|26.3|||||TWO_SIDED|95.0|11.9|38.3|||Regression, Cox||VE = 1 minus HR. HR was defined as the ratio of relative risk of infection in the vaccinated group compared to the control group.|Comparison of vaccine efficacy in the TVC against the first new genotypic infection, between enrollment and Month 32 visit, for Fx017-mFxD Group vs Control Group.||38.3|11.9|
72445049|NCT03281291|144404890|OTHER||Vaccine Efficacy|41.8|||||TWO_SIDED|95.0|28.6|52.5|||Regression, Cox||VE = 1 minus HR. HR was defined as the ratio of relative risk of infection in the vaccinated group compared to the control group.|Comparison of vaccine efficacy in the ATP cohort against the first new genotypic infection, between months 2.5 and 26, for R012-20 Group vs Control Group.||52.5|28.6|
72445050|NCT03281291|144404890|OTHER||Vaccine Efficacy|39.9|||||TWO_SIDED|95.0|26.8|50.6|||Regression, Cox||VE = 1 minus HR. HR was defined as the ratio of relative risk of infection in the vaccinated group compared to the control group.|Comparison of vaccine efficacy in the ATP cohort against the first new genotypic infection, between months 2.5 and 26, for R012-14-mD Group vs Control Group.||50.6|26.8|
72445051|NCT03281291|144404890|OTHER||Vaccine Efficacy|33.6|||||TWO_SIDED|95.0|19.3|45.3|||Regression, Cox||VE = 1 minus HR. HR was defined as the ratio of relative risk of infection in the vaccinated group compared to the control group.|Comparison of vaccine efficacy in the ATP cohort against the first new genotypic infection, between months 2.5 and 26, for Fx012-14-mFxD Group vs Control Group.||45.3|19.3|
72445052|NCT03281291|144404890|OTHER||Vaccine Efficacy|40.6|||||TWO_SIDED|95.0|27.2|51.5|||Regression, Cox||VE = 1 minus HR. HR was defined as the ratio of relative risk of infection in the vaccinated group compared to the control group.|Comparison of vaccine efficacy in the ATP cohort against the first new genotypic infection, between months 7.5 and 31, for Fx017-mFxD Group vs Control Group.||51.5|27.2|
72445053|NCT03281291|144404891|OTHER||Additive difference|-1.5|||||TWO_SIDED|95.0|-1.979|-1.022|||Wald Test|Wald tests were used to test for additive differences in VE differing from zero and to obtain a 95% confidence interval.|Additive difference was defined as the difference in the mean number of new molecularly confirmed malaria infections between each vaccine arm and the control arm.|To detect a significant difference in the mean number of new molecularly confirmed malaria infections in the TVC between enrollment and Month 20 visit, for R012-20 Group vs Control Group.||-1.022|-1.979|
72445054|NCT03281291|144404891|OTHER||Additive difference|-1.544|||||TWO_SIDED|95.0|-2.027|-1.061|||Wald test|Wald tests were used to test for additive differences in VE differing from zero and to obtain a 95% confidence interval.|Additive difference was defined as the difference in the mean number of new molecularly confirmed malaria infections between each vaccine arm and the control arm.|To detect a significant difference in the mean number of new molecularly confirmed malaria infections in the TVC between enrollment and Month 20 visit, for R012-14-mD Group vs Control Group.||-1.061|-2.027|
72497419|NCT02863068|144524840|SUPERIORITY|||||||1|||||||Fisher Exact|Difference in frequency of 25% total ulcerated surface area reduction between treatment arms for participants on Hydroxyurea (HU).||Difference in frequency of 25% total ulcerated surface area reduction between treatment arms for participants on Hydroxyurea (HU).||||1.0
72445055|NCT03281291|144404891|OTHER||Additive difference|-1.575|||||TWO_SIDED|95.0|-2.065|-1.085|||Wald test|Wald tests were used to test for additive differences in VE differing from zero and to obtain a 95% confidence interval.|Additive difference was defined as the difference in the mean number of new molecularly confirmed malaria infections between each vaccine arm and the control arm.|To detect a significant difference in the mean number of new molecularly confirmed malaria infections in the TVC between enrollment and Month 20 visit, for Fx012-14-mFxD Group vs Control Group.||-1.085|-2.065|
72445056|NCT03281291|144404891|OTHER||Additive difference|-1.11|||||TWO_SIDED|95.0|-1.635|-0.586|||Wald test|Wald tests were used to test for additive differences in VE differing from zero and to obtain a 95% confidence interval.|Additive difference was defined as the difference in the mean number of new molecularly confirmed malaria infections between each vaccine arm and the control arm.|To detect a significant difference in the mean number of new molecularly confirmed malaria infections in the TVC between enrollment and Month 20 visit, for Fx017-mFxD Group vs Control Group.||-0.586|-1.635|
72445057|NCT03281291|144404892|OTHER||Additive difference|-0.769|||||TWO_SIDED|95.0|-1.068|-0.469|||Wald test|Wald tests were used to test for additive differences in VE differing from zero and to obtain a 95% confidence interval|Additive difference was defined as the difference in the mean number of new molecularly confirmed malaria infections between each vaccine arm and the control arm.|To detect a significant difference in the mean number of new molecularly confirmed malaria infections in the ATP cohort between months 2.5 to 14, for R012-20 + R012-14-mD Pooled Group vs Control Group.||-0.469|-1.068|
72445058|NCT03281291|144404892|OTHER||Additive difference|-0.786|||||TWO_SIDED|95.0|-1.133|-0.439|||Wald test|Wald tests were used to test for additive differences in VE differing from zero and to obtain a 95% confidence interval|Additive difference was defined as the difference in the mean number of new molecularly confirmed malaria infections between each vaccine arm and the control arm.|To detect a significant difference in the mean number of new molecularly confirmed malaria infections in the ATP cohort between months 2.5 to 14, for Fx012-14-mFxD groups vs Control Group.||-0.439|-1.133|
72497420|NCT02863068|144524840|SUPERIORITY|||||||1|||||||Fisher Exact|Fisher's exact test was used to test for differences in frequencies between treatment arms for participants off Hydroxyurea (HU).||Difference in frequency of 25% total ulcerated surface area reduction between treatment arms for participants off Hydroxyurea (HU).||||1.0
72497421|NCT02863068|144524841|SUPERIORITY|||||||0.4298||||||A matched pairs design was employed to test for changes in average pain at baseline and EOS between treatment arms for participants on Hydroxyurea (HU) using a Wilcoxon signed rank test.|Wilcoxon (Mann-Whitney)|||Change in average pain from baseline to end of study (EOS) for participants on Hydroxyurea (HU).||||0.4298
72389472|NCT01153347|144286748|SUPERIORITY_OR_OTHER||LS mean|0.0|STANDARD_ERROR_OF_MEAN|0.3||0.868|TWO_SIDED|95.0|-0.64|0.54|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization SDS work/school domain score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||0.54|-0.64|0.868
72560650|NCT01540045|144651667|SUPERIORITY_OR_OTHER_LEGACY|||||||0.022|TWO_SIDED||||||McNemar|||We divide dilutions in two groups and dichotomized the patients into high and low sensibility to bitter taste. (PERCEPTION)||||0.022
72560651|NCT00936351|144651668|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.21||||0.04|TWO_SIDED||||||t-test, 2 sided|||||||.04
72560652|NCT02616380|144651671|OTHER||||||<|0.0001|||||||Paired t-test|The mean change was tested with a paired t-test without adjusting for baseline disease severity.||||||<0.0001
72560653|NCT02616380|144651672|OTHER||||||<|0.0001|||||||Paired t-test|||Change From Baseline in Physical Component Score at Week 12||||<0.0001
72560654|NCT02616380|144651672|OTHER||||||<|0.0001|||||||Paired t-test|||Change From Baseline in Physical Component Score at Week 24||||<0.0001
72560655|NCT02616380|144651672|OTHER||||||<|0.0001|||||||Paired t-test|||Change From Baseline in Mental Component Score at Week 12||||<0.0001
72560656|NCT02616380|144651672|OTHER||||||<|0.0001|||||||Paired t-test|||Change From Baseline in Mental Component Score at Week 24||||<0.0001
72560657|NCT02616380|144651673|OTHER||||||<|0.0001|||||||Paired t-test|||Change from Baseline in EQ-5D-3L at 12 weeks||||<0.0001
72560658|NCT02616380|144651673|OTHER||||||<|0.0001|||||||Paired t-test|||Change from Baseline in EQ-5D-3L at 24 weeks||||<0.0001
72560659|NCT02616380|144651674|OTHER||||||<|0.0001|||||||Paired t-test|||Change From Baseline in Overall Work Impairment at Week 12||||<0.0001
72560660|NCT02616380|144651674|OTHER||||||<|0.0001|||||||Paired t-test|||Change From Baseline in Overall Work Impairment at Week 24||||<0.0001
72560661|NCT02616380|144651674|OTHER||||||<|0.0001|||||||Paired t-test|||Change From Baseline in Activity Impairment at Week 12||||<0.0001
72560662|NCT02616380|144651674|OTHER||||||<|0.0001|||||||Paired t-test|||Change From Baseline in Activity Impairment at Week 24||||<0.0001
72560663|NCT02616380|144651675|OTHER||||||<|0.0001|||||||Paired t-test|The mean change was tested with a paired t-test without adjusting for baseline disease severity.||||||<0.0001
72389473|NCT01153347|144286748|SUPERIORITY_OR_OTHER||LS mean|0.1|STANDARD_ERROR_OF_MEAN|0.3||0.792|TWO_SIDED|95.0|-0.5|0.66|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization SDS work/school domain score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||0.66|-0.50|0.792
72389474|NCT01153347|144286749|SUPERIORITY_OR_OTHER||LS mean|0.0|STANDARD_ERROR_OF_MEAN|0.26||0.915|TWO_SIDED|95.0|-0.54|0.48|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization SDS social life domain score. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||0.48|-0.54|0.915
72389475|NCT01153347|144286749|SUPERIORITY_OR_OTHER||LS mean|0.0|STANDARD_ERROR_OF_MEAN|0.26||0.972|TWO_SIDED|95.0|-0.51|0.53|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization SDS social life domain score. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||0.53|-0.51|0.972
72389476|NCT01153347|144286749|SUPERIORITY_OR_OTHER||LS mean|0.3|STANDARD_ERROR_OF_MEAN|0.27||0.237|TWO_SIDED|95.0|-0.21|0.84|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization SDS social life domain score. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||0.84|-0.21|0.237
72389477|NCT01153347|144286750|SUPERIORITY_OR_OTHER||LS mean|-0.3|STANDARD_ERROR_OF_MEAN|0.27||0.213|TWO_SIDED|95.0|-0.87|0.19|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization SDS family life/home responsibilities domain score. Treatment, visit and treatment by visit interaction are effects in the model; pooled center is a random effect.||0.19|-0.87|0.213
72389478|NCT01153347|144286750|SUPERIORITY_OR_OTHER||LS mean|-0.3|STANDARD_ERROR_OF_MEAN|0.27||0.343|TWO_SIDED|95.0|-0.8|0.28|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization SDS family life/home responsibilities domain score. Treatment, visit and treatment by visit interaction are effects in the model; pooled center is a random effect.||0.28|-0.80|0.343
72389479|NCT01153347|144286750|SUPERIORITY_OR_OTHER||LS mean|0.0|STANDARD_ERROR_OF_MEAN|0.28||0.971|TWO_SIDED|95.0|-0.55|0.53|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization SDS family life/home responsibilities domain score. Treatment, visit and treatment by visit interaction are effects in the model; pooled center is a random effect.||0.53|-0.55|0.971
72389480|NCT01153347|144286751|SUPERIORITY_OR_OTHER||LS mean|2.1|STANDARD_ERROR_OF_MEAN|1.694||0.215|TWO_SIDED|95.0|-1.224|5.431|||ANCOVA|||ANCOVA with randomization Q-LES-Q-SF % maximum total score as covariate, treatment as a fixed effect and pooled center as a random effect.||5.431|-1.224|0.215
72389481|NCT01153347|144286751|SUPERIORITY_OR_OTHER||LS mean|0.72|STANDARD_ERROR_OF_MEAN|1.702||0.673|TWO_SIDED|95.0|-2.624|4.062|||ANCOVA|||ANCOVA with randomization Q-LES-Q-SF % maximum total score as covariate, treatment as a fixed effect and pooled center as a random effect.||4.062|-2.624|0.673
72389482|NCT01153347|144286751|SUPERIORITY_OR_OTHER||LS mean|-1.88|STANDARD_ERROR_OF_MEAN|1.716||0.275|TWO_SIDED|95.0|-5.248|1.494|||ANCOVA|||ANCOVA with randomization Q-LES-Q-SF % maximum total score as covariate, treatment as a fixed effect and pooled center as a random effect.||1.494|-5.248|0.275
72389483|NCT01153347|144286752|SUPERIORITY_OR_OTHER||LS mean|-0.1|STANDARD_ERROR_OF_MEAN|0.1||0.412|TWO_SIDED|95.0|-0.28|0.11|||ANCOVA|||An analysis of covariance (ANCOVA) with randomization Q-LES-Q-SF item 15 score as covariate, treatment as a fixed effect and pooled center as a random effect.||0.11|-0.28|0.412
72389484|NCT01153347|144286752|SUPERIORITY_OR_OTHER||LS mean|0.0|STANDARD_ERROR_OF_MEAN|0.1||0.928|TWO_SIDED|95.0|-0.19|0.21|||ANCOVA|||An analysis of covariance (ANCOVA) with randomization Q-LES-Q-SF item 15 score as covariate, treatment as a fixed effect and pooled center as a random effect.||0.21|-0.19|0.928
72445059|NCT03281291|144404892|OTHER||Additive difference|-1.275|||||TWO_SIDED|95.0|-1.592|-0.959|||Wald test|Wald tests were used to test for additive differences in VE differing from zero and to obtain a 95% confidence interval|Additive difference was defined as the difference in the mean number of new molecularly confirmed malaria infections between each vaccine arm and the control arm.|To detect a significant difference in the mean number of new molecularly confirmed malaria infections in the ATP cohort between months 7.5 to 19, for Fx017-mFxD groups vs Control Group.||-0.959|-1.592|
72445060|NCT03281291|144404893|OTHER||Additive difference|-2.686|||||TWO_SIDED|95.0|-3.448|-1.924|||Wald test|Wald tests were used to test for additive differences in VE differing from zero and to obtain a 95% confidence interval|Additive difference was defined as the difference in the mean number of new molecularly confirmed malaria infections between each vaccine arm and the control arm.|To detect a significant difference in the mean number of new molecularly confirmed malaria infections in the TVC between enrollment and Month 32 visit, for R012-20 Group vs Control Group.||-1.924|-3.448|
72445061|NCT03281291|144404893|OTHER||Additive difference|-2.452|||||TWO_SIDED|95.0|-3.217|-1.686|||Wald test|Wald tests were used to test for additive differences in VE differing from zero and to obtain a 95% confidence interval|Additive difference was defined as the difference in the mean number of new molecularly confirmed malaria infections between each vaccine arm and the control arm.|To detect a significant difference in the mean number of new molecularly confirmed malaria infections in the TVC between enrollment and Month 32 visit, for R012-14-mD Group vs Control Group.||-1.686|-3.217|
72445062|NCT03281291|144404893|OTHER||Additive difference|-2.585|||||TWO_SIDED|95.0|-3.345|-1.824|||Wald test|Wald tests were used to test for additive differences in VE differing from zero and to obtain a 95% confidence interval|Additive difference was defined as the difference in the mean number of new molecularly confirmed malaria infections between each vaccine arm and the control arm.|To detect a significant difference in the mean number of new molecularly confirmed malaria infections in the TVC between enrollment and Month 32 visit, for Fx012-14-mFxD Group vs Control Group.||-1.824|-3.345|
72445063|NCT03281291|144404893|OTHER||Additive difference|-1.897|||||TWO_SIDED|95.0|-2.726|-1.067|||Wald test|Wald tests were used to test for additive differences in VE differing from zero and to obtain a 95% confidence interval|Additive difference was defined as the difference in the mean number of new molecularly confirmed malaria infections between each vaccine arm and the control arm.|To detect a significant difference in the mean number of new molecularly confirmed malaria infections in the TVC between enrollment and Month 32 visit, for Fx017-mFxD Group vs Control Group.||-1.067|-2.726|
72497422|NCT02863068|144524841|SUPERIORITY|||||||0.2701||||||A matched pairs design was employed to test for changes in average pain at baseline and EOS between treatment arms for participants off Hydroxyurea (HU) using a Wilcoxon signed rank test.|Wilcoxon (Mann-Whitney)|||Change in average pain from baseline to end of study (EOS) for participants off Hydroxyurea (HU).||||0.2701
72497423|NCT01400932|144524859|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-21.0|||<|0.001|TWO_SIDED|95.0|-26.2|-15.8|||ANCOVA|||||-15.8|-26.2|<0.001
72497424|NCT01400932|144524860|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Week 1|ANCOVA|||||||<0.001
72497425|NCT01400932|144524860|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Week 2|ANCOVA|||||||<0.001
72560664|NCT03407729|144651683|OTHER|Using seed-based analysis with a 1) Left Thalamus seed and 2) Left Middle Temporal Gyrus seed, cluster size was set at 50 voxels and p-value was thresholded at p\<0.05. This was used to compare the differences between the two study groups in terms of number of activated voxels during during cognitive testing using the N-back.|||||<|0.05||||||The a priori threshold for statistical significance was p\<0.05 and statistical power was set at a minimum of 0.80.|t-test, 2 sided|||||||<0.05
72445064|NCT03281291|144404894|OTHER||Additive difference|-1.633|||||TWO_SIDED|95.0|-2.252|-1.015|||Wald test|Wald tests were used to test for additive differences in VE differing from zero and to obtain a 95% confidence interval.|Additive difference was defined as the difference in the mean number of new molecularly confirmed malaria infections between each vaccine arm and the control arm.|To detect a significant difference in the mean number of new molecularly confirmed malaria infections in the ATP cohort between months 2.5 to 26, for R012-20 group vs Control Group.||-1.015|-2.252|
72445065|NCT03281291|144404894|OTHER||Additive difference|-1.997|||||TWO_SIDED|95.0|-2.601|-1.393|||Wald test|Wald tests were used to test for additive differences in VE differing from zero and to obtain a 95% confidence interval.|Additive difference was defined as the difference in the mean number of new molecularly confirmed malaria infections between each vaccine arm and the control arm.|To detect a significant difference in the mean number of new molecularly confirmed malaria infections in the ATP cohort between months 2.5 to 26, for R012-14 group vs Control Group.||-1.393|-2.601|
72497426|NCT01400932|144524860|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Week 4|ANCOVA|||||||<0.001
72497427|NCT01400932|144524860|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Week 8|ANCOVA|||||||<0.001
72497428|NCT01400932|144524861|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Week 1; IL|ANCOVA|||||||<0.001
72497429|NCT01400932|144524861|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Week 2; IL|ANCOVA|||||||<0.001
72497430|NCT01400932|144524861|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Week 4; IL|ANCOVA|||||||<0.001
72497431|NCT01400932|144524861|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Week 8; IL|ANCOVA|||||||<0.001
72497432|NCT01400932|144524861|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Week 12; IL|ANCOVA|||||||<0.001
72497433|NCT01400932|144524861|SUPERIORITY_OR_OTHER|||||||0.007||95.0||||Week 1; NIL|ANCOVA|||||||0.007
72497434|NCT01400932|144524861|SUPERIORITY_OR_OTHER|||||||0.008||95.0||||Week 2; NIL|ANCOVA|||||||0.008
72497435|NCT01400932|144524861|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Week 4; NIL|ANCOVA|||||||<0.001
72497436|NCT01400932|144524861|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Week 8; NIL|ANCOVA|||||||<0.001
72497437|NCT01400932|144524861|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Week 12; NIL|ANCOVA|||||||<0.001
72497438|NCT01400932|144524862|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Week 1; Total|ANCOVA|||||||<0.001
72497439|NCT01400932|144524862|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Week 2; Total|ANCOVA|||||||<0.001
72497440|NCT01400932|144524862|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Week 4; Total|ANCOVA|||||||<0.001
72497441|NCT01400932|144524862|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Week 8; Total|ANCOVA|||||||<0.001
72497442|NCT01400932|144524862|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Week 12; Total|ANCOVA|||||||<0.001
72445066|NCT03281291|144404894|OTHER||Additive difference|-1.776|||||TWO_SIDED|95.0|-2.399|-1.153|||Wald test|Wald tests were used to test for additive differences in VE differing from zero and to obtain a 95% confidence interval.|Additive difference was defined as the difference in the mean number of new molecularly confirmed malaria infections between each vaccine arm and the control arm.|To detect a significant difference in the mean number of new molecularly confirmed malaria infections in the ATP cohort between months 2.5 to 26, for Fx012-14-mFxD group vs Control Group.||-1.153|-2.399|
72560665|NCT03950674|144651685|OTHER||Hazard Ratio (HR)|0.62||||0.12511|TWO_SIDED|95.0|0.27|1.42||One-sided p-value based on unstratified log-rank test|Log Rank||Based on Cox regression model with treatment as a covariate stratified by PD-L1 status (≥1% vs. \<1%), platinum chemotherapy (cisplatin vs. carboplatin) \& smoking status (never vs. former/current). Pembrolizumab=numerator; Control=denominator.|||1.42|0.27|0.12511
72445067|NCT03281291|144404894|OTHER||Additive difference|-1.843|||||TWO_SIDED|95.0|-2.527|-1.158|||Wald test|Wald tests were used to test for additive differences in VE differing from zero and to obtain a 95% confidence interval.|Additive difference was defined as the difference in the mean number of new molecularly confirmed malaria infections between each vaccine arm and the control arm.|To detect a significant difference in the mean number of new molecularly confirmed malaria infections in the ATP cohort between months 7.5 to 31, for Fx017-mFxD group vs Control Group.||-1.158|-2.527|
72445068|NCT04556656|144404967|SUPERIORITY||Mean Difference (Final Values)|-0.22|STANDARD_ERROR_OF_MEAN|0.162||0.167|TWO_SIDED|95.0|-0.54|0.09|||Mixed Models Analysis|||In the mixed model for repeated measures (MMRM), change from baseline in TFC score was the dependent variable, and independent variables included treatment arm, baseline TFC, region, neuroleptic use or no use, baseline HD stage (HD1 and HD2), categorical week, and treatment by categorical week interaction, with Kenward-Roger approximation for degrees of freedom. The unstructured covariance matrix was used for repeated measurements at patient level.||0.09|-0.54|0.1670
72445069|NCT04556656|144404968|SUPERIORITY||Mean Difference (Final Values)|-0.23|STANDARD_ERROR_OF_MEAN|0.162||0.1598|TWO_SIDED|95.0|-0.55|0.09|||Mixed Models Analysis|||In the mixed model for repeated measures (MMRM), change from baseline in TFC score was the dependent variable, and independent variables included treatment arm, baseline TFC, region, neuroleptic use or no use, baseline HD stage (HD1 and HD2), categorical week, and treatment by categorical week interaction, with Kenward-Roger approximation for degrees of freedom. The unstructured covariance matrix was used for repeated measurements at patient level.||0.09|-0.55|0.1598
72560666|NCT03950674|144651686|OTHER||Hazard Ratio (HR)|0.29||||0.03127|TWO_SIDED|95.0|0.07|1.15||One-sided p-value based on unstratified log-rank test|Log Rank||Based on Cox regression model with treatment as a covariate stratified by PD-L1 status (≥1% vs. \<1%), platinum chemotherapy (cisplatin vs. carboplatin) \& smoking status (never vs. former/current). Pembrolizumab=numerator; Control=denominator.|||1.15|0.07|0.03127
72560667|NCT00830167|144651694|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.44|STANDARD_ERROR_OF_MEAN|0.17||0.0046|TWO_SIDED|95.0|-0.78|-0.11||The analysis was conducted using 1-sided test with the significance level of 0.025. Actual significance level was calculated based on O'Brien-Fleming type alpha spending function of Lan and DeMets (1983).|ANCOVA|||The null hypothesis was to assume that there was no difference between the pregabalin and placebo groups. The alternative was that the pregabalin group was superior to the placebo group.||-0.11|-0.78|0.0046
72619260|NCT02006654|144769151|SUPERIORITY||Mean Difference (Final Values)|0.67|STANDARD_ERROR_OF_MEAN|0.63||0.4064|TWO_SIDED|95.0|-0.57|1.92||Corrected for multiplicity according to the multiple testing procedure|Mixed Models Analysis|Adjusted for effects of country, MMSE stratum-by-week, treatment-by-week, base treatment stratum-by-week, and baseline score-by-week interactions|A positive mean difference indicates a treatment effect in favour of idalopirdine|For demonstrating efficacy, change in cognition (ADAS-cog) and either change in daily functioning (ADCS-ADL23) or change in global clinical impression (ADCS-CGIC) had to show statistically significant favourable differences compared to placebo at Week 24. Multiple testing procedures were used to control the overall type 1 error at 5%. The null hypothesis of no difference in mean change from baseline in ADAS-cog total score at Week 24 was tested at significance level 5%.||1.92|-0.57|0.4064
72445070|NCT04556656|144404969|SUPERIORITY||Mean Difference (Final Values)|-0.11|STANDARD_ERROR_OF_MEAN|0.148||0.4544|TWO_SIDED|95.0|-0.4|0.18|||Mixed Models Analysis|||In the MMRM, change in cUHDRS score from baseline was the dependent variable, while independent variables included treatment arm, baseline cUHDRS, region, neuroleptic use or no use, baseline HD stage (HD1 and HD2), categorical week, and treatment by categorical week interaction, with Kenward-Roger approximation for degrees of freedom. The unstructured covariance matrix was used for repeated measurements at patient level. No imputation was performed on missing data.||0.18|-0.4|0.4544
72619261|NCT01933425|144769164|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.33|||<|0.05|TWO_SIDED|95.0|0.07|0.59|||t-test, 2 sided|||||0.59|0.07|<0.05
72619262|NCT01933425|144769165|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.3|||<|0.05|TWO_SIDED|95.0|0.06|0.54|||t-test, 2 sided|||||0.54|0.06|<0.05
72445071|NCT04556656|144404970|SUPERIORITY||Mean Difference (Final Values)|0.46|STANDARD_ERROR_OF_MEAN|0.156||0.0038|TWO_SIDED|95.0|0.15|0.76|||Mixed Models Analysis|||"From baseline to Week 26.~In the MMRM model, change in cUHDRS score from baseline was the dependent variable and independent variables included treatment group, baseline cUHDRS, region, categorical week, baseline HD stage (HD1 and HD2), and treatment by categorical week interaction, concomitant use of select medications and Treatment x Concomitant use of select medications, with Kenward-Roger approximation for degrees of freedom. No imputation was performed on missing data."||0.76|0.15|0.0038
72445072|NCT04556656|144404970|SUPERIORITY||Mean Difference (Final Values)|0.45|STANDARD_ERROR_OF_MEAN|0.179||0.0135|TWO_SIDED|95.0|0.09|0.8|||Mixed Models Analysis|||From baseline to Week 39||0.80|0.09|0.0135
72445073|NCT04556656|144404970|SUPERIORITY||Mean Difference (Final Values)|0.41|STANDARD_ERROR_OF_MEAN|0.193||0.0351|TWO_SIDED|95.0|0.03|0.79|||Mixed Models Analysis|||From baseline to Week 52||0.79|0.03|0.0351
72445074|NCT04556656|144404970|SUPERIORITY||Mean Difference (Final Values)|0.27|STANDARD_ERROR_OF_MEAN|0.197||0.1683|TWO_SIDED|95.0|-0.12|0.66|||Mixed Models Analysis|||From baseline to Week 65.||0.66|-0.12|0.1683
72497443|NCT01400932|144524862|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Week 1; IL|ANCOVA|||||||<0.001
72619263|NCT00063232|144769202|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||paired t-test|||"self-controlled comparison of NASH activity index at 48 weeks and baseline. Null hypothesis is no change."||||<0.001
72445075|NCT04556656|144404970|SUPERIORITY||Mean Difference (Final Values)|0.14|STANDARD_ERROR_OF_MEAN|0.223||0.5315|TWO_SIDED|95.0|-0.3|0.58|||Mixed Models Analysis|||From baseline to Week 78||0.58|-0.30|0.5315
72445076|NCT04556656|144404971|SUPERIORITY||Mean Difference (Final Values)|-21.15|STANDARD_ERROR_OF_MEAN|9.406||0.0253|TWO_SIDED|95.0|-39.66|-2.64|||Mixed Models Analysis||Negative change = improvement.|From baseline to Week 26. In the MMRM model, change in Q-Motor Finger Tapping IOI Mean from baseline was the dependent variable and independent variables included treatment group, baseline Finger Tapping IOI Mean, region, categorical week, baseline HD stage (HD1 and HD2), and treatment by categorical week interaction, concomitant use of select medications and Treatment x Concomitant use of select medications, with Kenward-Roger approximation for degrees of freedom. No imputation was performed.||-2.64|-39.66|0.0253
72445077|NCT04556656|144404971|SUPERIORITY||Mean Difference (Final Values)|-14.31|STANDARD_ERROR_OF_MEAN|9.853||0.1474|TWO_SIDED|95.0|-33.71|5.08|||Mixed Models Analysis|||From baseline to Week 52.||5.08|-33.71|0.1474
72445078|NCT04556656|144404971|SUPERIORITY||Mean Difference (Final Values)|-24.71|STANDARD_ERROR_OF_MEAN|10.185||0.0159|TWO_SIDED|95.0|-44.76|-4.67|||Mixed Models Analysis|||From baseline to Week 65.||-4.67|-44.76|0.0159
72445079|NCT04556656|144404971|SUPERIORITY||Mean Difference (Final Values)|-22.9|STANDARD_ERROR_OF_MEAN|10.38||0.0283|TWO_SIDED|95.0|-43.34|-2.45|||Mixed Models Analysis|||From baseline to Week 78.||-2.45|-43.34|0.0283
72445080|NCT04556656|144404972|SUPERIORITY||Mean Difference (Final Values)|-38.06|STANDARD_ERROR_OF_MEAN|10.999||0.0007|TWO_SIDED|95.0|-59.74|-16.37|||Mixed Models Analysis|||From baseline to Week 26. In MMRM model, change in Q-Motor Pronation/Supination ITI Mean from baseline was the dependent variable and independent variables included treatment group, baseline Q-Motor Pronation/Supination ITI Mean, region, categorical week, baseline HD stage (HD1 and HD2), and treatment by categorical week interaction, with Kenward-Roger approximation for degrees of freedom. No imputation was performed on missing data.||-16.37|-59.74|0.0007
72445081|NCT04556656|144404972|SUPERIORITY||Mean Difference (Final Values)|-20.21|STANDARD_ERROR_OF_MEAN|12.547||0.1087|TWO_SIDED|95.0|-44.95|4.53|||Mixed Models Analysis|||From baseline to Week 52.||4.53|-44.95|0.1087
72445082|NCT04556656|144404972|SUPERIORITY||Mean Difference (Final Values)|-23.92|STANDARD_ERROR_OF_MEAN|11.541||0.0395|TWO_SIDED|95.0|-46.68|-1.16|||Mixed Models Analysis|||From baseline to Week 65.||-1.16|-46.68|0.0395
72445083|NCT04556656|144404972|SUPERIORITY||Mean Difference (Final Values)|-22.23|STANDARD_ERROR_OF_MEAN|13.587||0.1038|TWO_SIDED|95.0|-49.08|4.61|||Mixed Models Analysis|||From baseline to Week 78.||4.61|-49.08|0.1038
72445084|NCT04556656|144404973|SUPERIORITY||Mean Difference (Final Values)|-30.38|STANDARD_ERROR_OF_MEAN|12.902||0.0193|TWO_SIDED|95.0|-55.78|-4.98|||Mixed Models Analysis|||From baseline to Week 26. In the MMRM model, change in Pronation/Supination IOI Mean from BL was the dependent variable and independent variables included treatment group, BL Pronation/Supination IOI Mean, region, categorical week, baseline HD stage (HD1 and HD2), treatment by categorical week interaction, conc. use of select medications and Treatment x Concomitant use of select medications, with Kenward-Roger approximation for degrees of freedom. No imputation was performed on missing data.||-4.98|-55.78|0.0193
72560668|NCT00830167|144651695|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0078|TWO_SIDED|||||The analysis was conducted using 2-sided test with the significance level of 0.05.|Chi-squared|||The null hypothesis was to assume that there was no difference between the pregabalin and placebo groups. The alternative was that there was a difference between the pregabalin and the placebo groups.||||0.0078
72445085|NCT04556656|144404973|SUPERIORITY||Mean Difference (Final Values)|-16.84|STANDARD_ERROR_OF_MEAN|15.17||0.268|TWO_SIDED|95.0|-46.69|13.02|||Mixed Models Analysis|||From baseline to Week 52.||13.02|-46.69|0.2680
72445086|NCT04556656|144404973|SUPERIORITY||Mean Difference (Final Values)|-22.79|STANDARD_ERROR_OF_MEAN|14.829||0.1255|TWO_SIDED|95.0|-51.97|6.4|||Mixed Models Analysis|||From baseline to Week 65.||6.4|-51.97|0.1255
72445087|NCT04556656|144404973|SUPERIORITY||Mean Difference (Final Values)|-22.72|STANDARD_ERROR_OF_MEAN|17.777||0.2024|TWO_SIDED|95.0|-57.72|12.28|||Mixed Models Analysis|||From baseline to Week 78.||12.28|-57.72|0.2024
72445088|NCT04556656|144404974|SUPERIORITY||Mean Difference (Final Values)|0.22|STANDARD_ERROR_OF_MEAN|0.179||0.2088|TWO_SIDED|95.0|-0.13|0.58|||Mixed Models Analysis|||"From baseline to Week 26.~In the MMRM model, change in UHDRS-TFC score from baseline was the dependent variable and independent variables included treatment group, Baseline UHDRS-TFC, region, categorical week, Baseline HD stage (HD1 and HD2), and treatment by categorical week interaction, concomitant use of select medications and Treatment x Concomitant use of select medications, with Kenward-Roger approximation for degrees of freedom. No imputation was performed on missing data."||0.58|-0.13|0.2088
72445089|NCT04556656|144404974|SUPERIORITY||Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|0.188||0.2991|TWO_SIDED|95.0|-0.17|0.57|||Mixed Models Analysis|||From baseline to Week 39.||0.57|-0.17|0.2991
72445090|NCT04556656|144404974|SUPERIORITY||Mean Difference (Final Values)|0.26|STANDARD_ERROR_OF_MEAN|0.205||0.2116|TWO_SIDED|95.0|-0.15|0.66|||Mixed Models Analysis|||From baseline to Week 52.||0.66|-0.15|0.2116
72445091|NCT04556656|144404974|SUPERIORITY||Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.215||0.8242|TWO_SIDED|95.0|-0.38|0.47|||Mixed Models Analysis|||From baseline to Week 65.||0.47|-0.38|0.8242
72445092|NCT04556656|144404974|SUPERIORITY||Mean Difference (Final Values)|0.12|STANDARD_ERROR_OF_MEAN|0.231||0.5918|TWO_SIDED|95.0|-0.33|0.58|||Mixed Models Analysis|||From baseline to Week 78.||0.58|-0.33|0.5918
72445093|NCT04556656|144404975|SUPERIORITY||Mean Difference (Final Values)|3.16|STANDARD_ERROR_OF_MEAN|1.326||0.0178|TWO_SIDED|95.0|0.55|5.77|||Mixed Models Analysis|||From baseline to Week 26. In the MMRM model, change in SWR score from baseline was the dependent variable and independent variables included treatment group, baseline SWR, region, categorical week, baseline HD stage (HD1 and HD2), and treatment by categorical week interaction, concomitant use of select medications and Treatment x Concomitant use of select medications, with Kenward-Roger approximation for degrees of freedom. No imputation was performed on missing data.||5.77|0.55|0.0178
72445094|NCT04556656|144404975|SUPERIORITY||Mean Difference (Final Values)|2.89|STANDARD_ERROR_OF_MEAN|1.518||0.0576|TWO_SIDED|95.0|-0.09|5.88|||Mixed Models Analysis|||From baseline to Week 39.||5.88|-0.09|0.0576
72445095|NCT04556656|144404975|SUPERIORITY||Mean Difference (Final Values)|3.05|STANDARD_ERROR_OF_MEAN|1.493||0.0418|TWO_SIDED|95.0|0.11|5.99|||Mixed Models Analysis|||From baseline to Week 52.||5.99|0.11|0.0418
72497444|NCT01400932|144524862|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Week 2; IL|ANCOVA|||||||<0.001
72497445|NCT01400932|144524862|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Week 4; IL|ANCOVA|||||||<0.001
72497446|NCT01400932|144524862|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Week 8; IL|ANCOVA|||||||<0.001
72497447|NCT01400932|144524862|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Week 12; IL|ANCOVA|||||||<0.001
72497448|NCT01400932|144524862|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||Week 1; NIL|ANCOVA|||||||0.002
72497449|NCT01400932|144524862|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Week 2; NIL|ANCOVA|||||||<0.001
72497450|NCT01400932|144524862|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Week 4; NIL|ANCOVA|||||||<0.001
72497451|NCT01400932|144524862|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Week 8; NIL|ANCOVA|||||||<0.001
72497452|NCT01400932|144524862|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Week 12; NIL|ANCOVA|||||||<0.001
72497453|NCT01400932|144524863|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||||||<0.001
72497454|NCT01400932|144524864|SUPERIORITY_OR_OTHER|||||||0.174||95.0||||Week 1|ANCOVA|||||||0.174
72497455|NCT01400932|144524864|SUPERIORITY_OR_OTHER|||||||0.013||95.0||||Week 2|ANCOVA|||||||0.013
72389485|NCT01153347|144286752|SUPERIORITY_OR_OTHER||LS mean|-0.2|STANDARD_ERROR_OF_MEAN|0.1||0.033|TWO_SIDED|95.0|-0.42|-0.02|||ANCOVA|||An analysis of covariance (ANCOVA) with randomization Q-LES-Q-SF item 15 score as covariate, treatment as a fixed effect and pooled center as a random effect.||-0.02|-0.42|0.033
72389486|NCT01153347|144286753|SUPERIORITY_OR_OTHER||LS mean|0.1|STANDARD_ERROR_OF_MEAN|0.1||0.353|TWO_SIDED|95.0|-0.1|0.28|||ANCOVA|||An analysis of covariance (ANCOVA) with randomization Q-LES-Q-SF item 16 as a fixed effect and pooled center as a random effect.||0.28|-0.10|0.353
72389487|NCT01153347|144286753|SUPERIORITY_OR_OTHER||LS mean|0.0|STANDARD_ERROR_OF_MEAN|0.1||0.721|TWO_SIDED|95.0|-0.16|0.23|||ANCOVA|||An analysis of covariance (ANCOVA) with randomization Q-LES-Q-SF item 16 as a fixed effect and pooled center as a random effect.||0.23|-0.16|0.721
72389488|NCT01153347|144286753|SUPERIORITY_OR_OTHER||LS mean|0.0|STANDARD_ERROR_OF_MEAN|0.1||0.666|TWO_SIDED|95.0|-0.24|0.15|||ANCOVA|||An analysis of covariance (ANCOVA) with randomization Q-LES-Q-SF item 16 as a fixed effect and pooled center as a random effect.||0.15|-0.24|0.666
72389489|NCT01153347|144286754|SUPERIORITY_OR_OTHER||LS mean|-0.006|STANDARD_ERROR_OF_MEAN|0.0201||0.747|TWO_SIDED|95.0|-0.0459|0.0329||Analysis for change in EQ-5D index score from randomization (Week 8) to end of treatment (Week 16)|MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization EQ-5D total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||0.0329|-0.0459|0.747
72389490|NCT01153347|144286754|SUPERIORITY_OR_OTHER||LS mean|-0.013|STANDARD_ERROR_OF_MEAN|0.0203||0.524|TWO_SIDED|95.0|-0.0529|0.027||Analysis for change in EQ-5D index score from randomization (Week 8) to end of treatment (Week 16)|MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization EQ-5D total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||0.0270|-0.0529|0.524
72389491|NCT01153347|144286754|SUPERIORITY_OR_OTHER||LS mean|-0.014|STANDARD_ERROR_OF_MEAN|0.0206||0.502|TWO_SIDED|95.0|-0.0543|0.0267||Analysis for change in EQ-5D index score from randomization (Week 8) to end of treatment (Week 16)|MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization EQ-5D total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||0.0267|-0.0543|0.502
72389492|NCT01153347|144286754|SUPERIORITY_OR_OTHER||LS mean|1.9|STANDARD_ERROR_OF_MEAN|2.06||0.345|TWO_SIDED|95.0|-2.1|6.0||Analysis of change in EQ-5D VAS score from randomization (Week 8) to end of treatment (Week 16)|MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization EQ-5D VAS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||6.00|-2.10|0.345
72389493|NCT01153347|144286754|SUPERIORITY_OR_OTHER||LS mean|1.5|STANDARD_ERROR_OF_MEAN|2.09||0.486|TWO_SIDED|95.0|-2.65|5.56||Analysis of change in EQ-5D VAS score from randomization (Week 8) to end of treatment (Week 16)|MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization EQ-5D VAS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||5.56|-2.65|0.486
72389494|NCT01153347|144286754|SUPERIORITY_OR_OTHER||LS mean|-1.2|STANDARD_ERROR_OF_MEAN|2.12||0.564|TWO_SIDED|95.0|-5.39|2.94||Analysis of change in EQ-5D VAS score from randomization (Week 8) to end of treatment (Week 16)|MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization EQ-5D VAS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||2.94|-5.39|0.564
72389495|NCT01153347|144286755|SUPERIORITY_OR_OTHER||LS mean|-1.4|STANDARD_ERROR_OF_MEAN|1.55||0.35|TWO_SIDED|95.0|-4.48|1.59|||MMRM|||MMRM model includes treatment, pooled center, visit, and treatment by visit interaction as explanatory variables and the randomization SIS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||1.59|-4.48|0.350
72389496|NCT01153347|144286755|SUPERIORITY_OR_OTHER||LS mean|-1.3|STANDARD_ERROR_OF_MEAN|1.56||0.393|TWO_SIDED|95.0|-4.41|1.73|||MMRM|||MMRM model includes treatment, pooled center, visit, and treatment by visit interaction as explanatory variables and the randomization SIS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||1.73|-4.41|0.393
72389497|NCT01153347|144286755|SUPERIORITY_OR_OTHER||LS mean|0.5|STANDARD_ERROR_OF_MEAN|1.58||0.745|TWO_SIDED|95.0|-2.59|3.62|||MMRM|||MMRM model includes treatment, pooled center, visit, and treatment by visit interaction as explanatory variables and the randomization SIS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||3.62|-2.59|0.745
72389498|NCT01751178|144286763|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.061|||<|0.0001|TWO_SIDED|95.0|-0.081|-0.041||From ANCOVA with factors for treatment group, site, smoking status, number of bleeding sites strata and the baseline GSI as a covariate.|ANCOVA||Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.|Null hypothesis stated that there was no difference between the two groups.||-0.041|-0.081|<0.0001
72445096|NCT04556656|144404975|SUPERIORITY||Mean Difference (Final Values)|2.32|STANDARD_ERROR_OF_MEAN|1.719||0.1775|TWO_SIDED|95.0|-1.06|5.71|||Mixed Models Analysis|||From baseline to Week 65.||5.71|-1.06|0.1775
72445097|NCT04556656|144404975|SUPERIORITY||Mean Difference (Final Values)|1.99|STANDARD_ERROR_OF_MEAN|1.772||0.2627|TWO_SIDED|95.0|-1.5|5.48|||Mixed Models Analysis|||From baseline to Week 78.||5.48|-1.50|0.2627
72445098|NCT04556656|144404976|SUPERIORITY||Mean Difference (Final Values)|1.01|STANDARD_ERROR_OF_MEAN|0.712||0.1586|TWO_SIDED|95.0|-0.4|2.41|||Mixed Models Analysis|||From baseline to Week 26. In the MMRM model, change in SDMT score from baseline was the dependent variable and independent variables included treatment group, baseline SDMT, region, categorical week, baseline HD stage (HD1 and HD2), and treatment by categorical week interaction, with Kenward-Roger approximation for degrees of freedom. No imputation was performed on missing data.||2.41|-0.4|0.1586
72445099|NCT04556656|144404976|SUPERIORITY||Mean Difference (Final Values)|0.87|STANDARD_ERROR_OF_MEAN|0.701||0.2144|TWO_SIDED|95.0|-0.51|2.25|||Mixed Models Analysis|||From baseline to Week 39. In the MMRM model, change in SDMT score from baseline was the dependent variable and independent variables included treatment group, baseline SDMT, region, categorical week, baseline HD stage (HD1 and HD2), and treatment by categorical week interaction, with Kenward-Roger approximation for degrees of freedom. No imputation was performed on missing data.||2.25|-0.51|0.2144
72445100|NCT04556656|144404976|SUPERIORITY||Mean Difference (Final Values)|-0.09|STANDARD_ERROR_OF_MEAN|0.793||0.9119|TWO_SIDED|95.0|-1.65|1.48|||Mixed Models Analysis|||From baseline to Week 52. In the MMRM model, change in SDMT score from baseline was the dependent variable and independent variables included treatment group, baseline SDMT, region, categorical week, baseline HD stage (HD1 and HD2), and treatment by categorical week interaction, with Kenward-Roger approximation for degrees of freedom. No imputation was performed on missing data.||1.48|-1.65|0.9119
72445101|NCT04556656|144404976|SUPERIORITY||Mean Difference (Final Values)|0.29|STANDARD_ERROR_OF_MEAN|0.844||0.7339|TWO_SIDED|95.0|-1.38|1.95|||Mixed Models Analysis|||From baseline to Week 65. In the MMRM model, change in SDMT score from baseline was the dependent variable and independent variables included treatment group, baseline SDMT, region, categorical week, baseline HD stage (HD1 and HD2), and treatment by categorical week interaction, with Kenward-Roger approximation for degrees of freedom. No imputation was performed on missing data.||1.95|-1.38|0.7339
72445102|NCT04556656|144404976|SUPERIORITY||Mean Difference (Final Values)|0.43|STANDARD_ERROR_OF_MEAN|0.859||0.6213|TWO_SIDED|95.0|-1.27|2.12|||Mixed Models Analysis|||From baseline to Week 78. In the MMRM model, change in SDMT score from baseline was the dependent variable and independent variables included treatment group, baseline SDMT, region, categorical week, baseline HD stage (HD1 and HD2), and treatment by categorical week interaction, with Kenward-Roger approximation for degrees of freedom. No imputation was performed on missing data.||2.12|-1.27|0.6213
72445103|NCT04556656|144404977|SUPERIORITY||Mean Difference (Final Values)|-0.18|STANDARD_ERROR_OF_MEAN|0.777||0.8205|TWO_SIDED|95.0|-1.71|1.36|||Mixed Models Analysis|||From baseline to Week 26. In the MMRM model, change in TMS score from baseline was the dependent variable and independent variables included treatment group, baseline TMS, region, categorical week, baseline HD stage (HD1 and HD2), and treatment by categorical week interaction, with Kenward-Roger approximation for degrees of freedom. No imputation was performed on missing data.||1.36|-1.71|0.8205
72497456|NCT01400932|144524864|SUPERIORITY_OR_OTHER|||||||0.001||95.0||||Week 4|ANCOVA|||||||0.001
72497457|NCT01400932|144524864|SUPERIORITY_OR_OTHER|||||||0.001||95.0||||Week 8|ANCOVA|||||||0.001
72497458|NCT01400932|144524864|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Week 12|ANCOVA|||||||<0.001
72497459|NCT01400932|144524865|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Week 1|ANCOVA|||||||<0.001
72497460|NCT01400932|144524865|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Week 2|ANCOVA|||||||<0.001
72497461|NCT01400932|144524865|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Week 4|ANCOVA|||||||<0.001
72497462|NCT01400932|144524865|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Week 8|ANCOVA|||||||<0.001
72497463|NCT01400932|144524865|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Week 12|ANCOVA|||||||<0.001
72497464|NCT02939131|144524874|SUPERIORITY|We tested the null hypothesis that the treatment group means were equal vs. not. The study was designed for at least 80% power to detect an effect size of 0.8 standard deviations (SD), which corresponded to a difference of four points. We assumed an intracluster correlation coefficient (ICC) between 0.02 and 0.16 and allowed for 10% non-evaluability. In a pre-planned interim analysis, we estimated the ICC based on the entry QIDS-SR to be 0.10.|Mean Difference (Final Values)|-3.86||||0.01|TWO_SIDED|95.0|-6.79|-0.94|||t-test, 2 sided||We subtracted the mean of the ESC group from the mean of the COMB-R group. Because a lower score indicated less severe depressive symptoms, a negative value indicated superiority.|||-0.94|-6.79|0.01
72497465|NCT02939131|144524875|SUPERIORITY|We tested the null hypothesis that the treatment group means were equal vs. not.|Mean Difference (Final Values)|44.3|||<|0.001|TWO_SIDED|95.0|23.1|65.5|||t-test, 2 sided||We subtracted the group mean of the site percents with response for the ESC group from that of the COMB-R group. A positive value indicates the COMB-R group had a higher mean percent of participants with response compared to the ESC group.|||65.5|23.1|<0.001
72497466|NCT02939131|144524876|SUPERIORITY|We tested the null hypothesis that the treatment group means were equal vs. not.|Mean Difference (Final Values)|30.9||||0.01|TWO_SIDED|95.0|8.9|52.9|||t-test, 2 sided||We subtracted the group mean of the site percents with remission for the ESC group from the COMB-R group so a positive value indicates the COMB-R group has more participants with remission.|||52.9|8.9|0.01
72497467|NCT02939131|144524877|SUPERIORITY|We tested the null hypothesis that the treatment group means were equal vs. not.|Mean Difference (Final Values)|19.0||||0.86|TWO_SIDED|95.0|-223.0|262.0|||t-test, 2 sided||Group mean for ESC is subtracted from the group mean for COMB-R. The group means are the means of the site mean CD4 cell counts.|||262|-223|0.86
72497468|NCT02939131|144524878|SUPERIORITY|We tested the null hypothesis that the treatment group means were equal vs. not.|Mean Difference (Final Values)|0.17||||0.66|TWO_SIDED|95.0|-0.65|0.99|||t-test, 2 sided||We subtracted the group mean for the ESC group from the group mean of the COMB-R group. The group means are the means of the site mean log10 HIV RNA copies/mL.|||0.99|-0.65|0.66
72497469|NCT02939131|144524879|SUPERIORITY||Mean Difference (Final Values)|2.0||||0.04|TWO_SIDED|95.0|0.1|4.0|||t-test, 2 sided||A positive difference indicates COMB-R group had a site-level average of more days in last 30 with missed HIV medication doses.|Comparison of COMB-R and ESC groups, number of days in last 30 with any missed HIV medication doses reported at week 24.||4.0|0.1|0.04
72445104|NCT04556656|144404977|SUPERIORITY||Mean Difference (Final Values)|-0.9|STANDARD_ERROR_OF_MEAN|1.067||0.4028|TWO_SIDED|95.0|-3.0|1.21|||Mixed Models Analysis|||From baseline to Week 39. In the MMRM model, change in TMS score from baseline was the dependent variable and independent variables included treatment group, baseline TMS, region, categorical week, baseline HD stage (HD1 and HD2), and treatment by categorical week interaction, with Kenward-Roger approximation for degrees of freedom. No imputation was performed on missing data.||1.21|-3.0|0.4028
72445105|NCT04556656|144404977|SUPERIORITY||Mean Difference (Final Values)|-0.32|STANDARD_ERROR_OF_MEAN|1.051||0.7577|TWO_SIDED|95.0|-2.4|1.75|||Mixed Models Analysis|||From baseline to Week 52. In the MMRM model, change in TMS score from baseline was the dependent variable and independent variables included treatment group, baseline TMS, region, categorical week, baseline HD stage (HD1 and HD2), and treatment by categorical week interaction, with Kenward-Roger approximation for degrees of freedom. No imputation was performed on missing data.||1.75|-2.4|0.7577
72445106|NCT04556656|144404977|SUPERIORITY||Mean Difference (Final Values)|-0.35|STANDARD_ERROR_OF_MEAN|1.158||0.7605|TWO_SIDED|95.0|-2.64|1.93|||Mixed Models Analysis|||From baseline to Week 65. In the MMRM model, change in TMS score from baseline was the dependent variable and independent variables included treatment group, baseline TMS, region, categorical week, baseline HD stage (HD1 and HD2), and treatment by categorical week interaction, with Kenward-Roger approximation for degrees of freedom. No imputation was performed on missing data.||1.93|-2.64|0.7605
72445107|NCT04556656|144404977|SUPERIORITY||Mean Difference (Final Values)|0.57|STANDARD_ERROR_OF_MEAN|1.323||0.6694|TWO_SIDED|95.0|-2.05|3.18|||Mixed Models Analysis|||From baseline to Week 78. In the MMRM model, change in TMS score from baseline was the dependent variable and independent variables included treatment group, baseline TMS, region, categorical week, baseline HD stage (HD1 and HD2), and treatment by categorical week interaction, with Kenward-Roger approximation for degrees of freedom. No imputation was performed on missing data.||3.18|-2.05|0.6694
72445108|NCT03498651|144404978|SUPERIORITY||Mean Difference (Net)|1.1|STANDARD_DEVIATION|0.03|||TWO_SIDED|95.0|1.04|1.16|||Mixed Models Analysis|We compared the two groups in a piecewise linear multilevel model (one slope during treatment, one during follow-up), controlling for income and age.|From the model (run in Bayesian with non-informative priors), we report the between-group SMD (with empirical SD \& 95% bootstrap confidence interval) at Session 5 (at mean income \& age), adjusted for baseline differences \& using pooled baseline SD.|"Intent-to-treat (ITT) analysis of Stage 1 randomization to CBM-I vs. psychoeducation. To correct for sampling bias (i.e., CBM-I, high attrition, coach received coaching, whereas psychoeducation did not receive coaching), CBM-I, high attrition, coach participants were excluded and replaced with an equal number of CBM-I, high attrition, no coach participants (using bootstrap resampling). The corrected ITT analysis sample included 1,234 participants (980 in CBM-I, 254 in psychoeducation)."||1.16|1.04|
72445109|NCT03498651|144404978|SUPERIORITY||Mean Difference (Net)|-0.12|STANDARD_DEVIATION|0.16|||TWO_SIDED|95.0|-0.43|0.2|||Mixed Models Analysis|We compared the two groups in a piecewise linear multilevel model (one slope during treatment, one during follow-up), controlling for income and age.|From the model (run in Bayesian with non-informative priors), we report the between-group SMD (with empirical SD \& 95% HPD credible interval) at Session 5 (at mean income \& age), adjusted for baseline differences \& using pooled baseline SD.|"Analysis of Stage 2 randomization of CBM-I participants classified as high risk for attrition to supplemental coaching vs. no coaching. The analysis sample included 544 participants (263 in CBM-I, high attrition, no coach; 281 in CBM-I, high attrition, coach)."||0.20|-0.43|
72445110|NCT03498651|144404979|SUPERIORITY||Mean Difference (Net)|-0.63|STANDARD_DEVIATION|0.03|||TWO_SIDED|95.0|-0.69|-0.57|||Mixed Models Analysis|We compared the two groups in a piecewise linear multilevel model (one slope during treatment, one during follow-up), controlling for income and age.|From the model (run in Bayesian with non-informative priors), we report the between-group SMD (with empirical SD \& 95% bootstrap confidence interval) at Session 5 (at mean income \& age), adjusted for baseline differences \& using pooled baseline SD.|"Intent-to-treat (ITT) analysis of Stage 1 randomization to CBM-I vs. psychoeducation. To correct for sampling bias (i.e., CBM-I, high attrition, coach received coaching, whereas psychoeducation did not receive coaching), CBM-I, high attrition, coach participants were excluded and replaced with an equal number of CBM-I, high attrition, no coach participants (using bootstrap resampling). The corrected ITT analysis sample included 1,234 participants (980 in CBM-I, 254 in psychoeducation)."||-0.57|-0.69|
72497470|NCT02939131|144524879|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.96|TWO_SIDED|95.0|-5.0|5.2|||t-test, 2 sided||A positive difference reflects greater number of days with missed HIV medication doses in last 30 days for COMB-R group.|Comparison of COMB-R and ESC groups, number of days in last 30 with any missed HIV medication doses reported at week 48.||5.2|-5.0|0.96
72497471|NCT02939131|144524880|SUPERIORITY||Mean Difference (Final Values)|-0.4||||0.27|TWO_SIDED|95.0|-1.1|0.4|||t-test, 2 sided||A positive difference means the COMB-R group rated adherence to HIV medications better than the ESC group.|Comparison of COMB-R and ESC groups, how good was participant at taking HIV medication doses; reported at week 24.||0.4|-1.1|0.27
72497472|NCT02939131|144524880|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.44|TWO_SIDED|95.0|-0.4|0.9|||t-test, 2 sided||A positive difference would indicate the COMB-R group rated their adherence better than the ESC group.|Comparison of COMB-R and ESC groups, how good was participant at taking HIV medication doses; reported at week 48.||0.9|-0.4|0.44
72497473|NCT02939131|144524881|SUPERIORITY||Mean Difference (Final Values)|-0.5||||0.14|TWO_SIDED|95.0|-1.1|0.2|||t-test, 2 sided||A positive difference would indicate the COMB-R group rated their adherence better than the ESC group.|Comparison of COMB-R and ESC groups, how often did participant take HIV medication as instructed; reported at week 24.||0.2|-1.1|0.14
72560669|NCT00830167|144651696|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-9.48|STANDARD_ERROR_OF_MEAN|1.85|<|0.0001|TWO_SIDED|95.0|-13.12|-5.85||The analysis was conducted using 1-sided test with the significance level of 0.025.|ANCOVA|||The null hypothesis was to assume that there was no difference between the pregabalin and placebo groups. The alternative was that the pregabalin group was superior to the placebo group.||-5.85|-13.12|<0.0001
72560670|NCT00830167|144651697|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.98|STANDARD_ERROR_OF_MEAN|1.88||0.9958|TWO_SIDED|95.0|1.29|8.68||The analysis was conducted using 1-sided test with the significance level of 0.025.|ANCOVA|||The null hypothesis was to assume that there was no difference between the pregabalin and placebo groups. The alternative was that the pregabalin group was superior to the placebo group.||8.68|1.29|0.9958
72445111|NCT03498651|144404979|SUPERIORITY||Mean Difference (Net)|0.06|STANDARD_DEVIATION|0.17|||TWO_SIDED|95.0|-0.26|0.39|||Mixed Models Analysis|We compared the two groups in a piecewise linear multilevel model (one slope during treatment, one during follow-up), controlling for income and age.|From the model (run in Bayesian with non-informative priors), we report the between-group SMD (with empirical SD \& 95% HPD credible interval) at Session 5 (at mean income \& age), adjusted for baseline differences \& using pooled baseline SD.|"Analysis of Stage 2 randomization of CBM-I participants classified as high risk for attrition to supplemental coaching vs. no coaching. The analysis sample included 544 participants (263 in CBM-I, high attrition, no coach; 281 in CBM-I, high attrition, coach)."||0.39|-0.26|
72445112|NCT03498651|144404980|SUPERIORITY||Mean Difference (Net)|0.48|STANDARD_DEVIATION|0.03|||TWO_SIDED|95.0|0.42|0.54|||Mixed Models Analysis|We compared the two groups in a piecewise linear multilevel model (one slope during treatment, one during follow-up), controlling for income and age.||"Intent-to-treat (ITT) analysis of Stage 1 randomization to CBM-I vs. psychoeducation. To correct for sampling bias (i.e., CBM-I, high attrition, coach received coaching, whereas psychoeducation did not receive coaching), CBM-I, high attrition, coach participants were excluded and replaced with an equal number of CBM-I, high attrition, no coach participants (using bootstrap resampling). The corrected ITT analysis sample included 1,234 participants (980 in CBM-I, 254 in psychoeducation)."|From the model (run in Bayesian with non-informative priors), we report the between-group SMD (with empirical SD \& 95% bootstrap confidence interval) at Session 5 (at mean income \& age), adjusted for baseline differences \& using pooled baseline SD.|0.54|0.42|
72445113|NCT03498651|144404980|SUPERIORITY||Mean Difference (Net)|0.08|STANDARD_DEVIATION|0.16|||TWO_SIDED|95.0|-0.23|0.39|||Mixed Models Analysis|We compared the two groups in a piecewise linear multilevel model (one slope during treatment, one during follow-up), controlling for income and age.|From the model (run in Bayesian with non-informative priors), we report the between-group SMD (with empirical SD \& 95% HPD credible interval) at Session 5 (at mean income \& age), adjusted for baseline differences \& using pooled baseline SD.|"Analysis of Stage 2 randomization of CBM-I participants classified as high risk for attrition to supplemental coaching vs. no coaching. The analysis sample included 544 participants (263 in CBM-I, high attrition, no coach; 281 in CBM-I, high attrition, coach)."||0.39|-0.23|
72497474|NCT02939131|144524881|SUPERIORITY||Mean Difference (Final Values)|0.3||||0.49|TWO_SIDED|95.0|-0.6|1.1|||t-test, 2 sided||A positive difference would indicate the COMB-R group rated their adherence better than the ESC group.|Comparison of COMB-R and ESC groups, how often did participant take HIV medication as instructed; reported at week 48.||1.1|-0.6|0.49
72497475|NCT02939131|144524882|SUPERIORITY||Mean Difference (Final Values)|2.2||||0.05|TWO_SIDED|95.0|0.0|4.4|||t-test, 2 sided||A positive difference would indicate those in the COMB-R group had more days with missed depression medications than those in the ESC group.|Comparison of COMB-R and ESC groups, number of days in last 30 with any missed depression medication doses reported at week 24.||4.4|0.0|0.05
72497476|NCT02939131|144524882|SUPERIORITY||Mean Difference (Final Values)|-2.7||||0.53|TWO_SIDED|95.0|-12.5|7.1|||t-test, 2 sided||A positive difference would indicate those in the COMB-R group reported more days with missed doses than those in the ESC group.|Comparison of COMB-R and ESC groups, number of days in last 30 with any missed depression medication doses reported at week 48.||7.1|-12.5|0.53
72497477|NCT02939131|144524883|SUPERIORITY||Mean Difference (Final Values)|-0.6||||0.13|TWO_SIDED|95.0|-1.5|0.2|||t-test, 2 sided||A positive difference would indicate those in the COMB-R group were better at taking medications.|Comparison of COMB-R and ESC groups, how good was participant at taking depression medication; reported at week 24.||0.2|-1.5|0.13
72497478|NCT02939131|144524883|SUPERIORITY||Mean Difference (Final Values)|0.5||||0.53|TWO_SIDED|95.0|-1.1|2.0|||t-test, 2 sided||A positive difference would indicate those in the COMB-R group were better at taking their medications.|Comparison of COMB-R and ESC groups, how good was participant at taking depression medication; reported at week 48.||2.0|-1.1|0.53
72497479|NCT02939131|144524884|SUPERIORITY||Mean Difference (Final Values)|-0.6||||0.07|TWO_SIDED|95.0|-1.3|0.1|||t-test, 2 sided||A positive difference would indicate those in the COMB-R group reported better adherence.|Comparison of COMB-R and ESC groups, how often did participant take depression medication as instructed; reported at week 24.||0.1|-1.3|0.07
72497480|NCT02939131|144524884|SUPERIORITY||Mean Difference (Final Values)|0.8||||0.28|TWO_SIDED|95.0|-0.8|2.3|||t-test, 2 sided||A positive difference would indicate those in the COMB-R group reported better adherence than those in the ESC group.|Comparison of COMB-R and ESC groups, how often did participant take depression medication as instructed; reported at week 48.||2.3|-0.8|0.28
72619264|NCT00063232|144769203|SUPERIORITY_OR_OTHER|||||||0.04||95.0|||||Fisher Exact|||self-controlled comparison of serum aminotransferase levels at 48 weeks and baseline. Null hypothesis: No change||||0.04
72497481|NCT02939131|144524885|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.44|TWO_SIDED|95.0|-0.6|0.3|||t-test, 2 sided|||||0.3|-0.6|0.44
72497482|NCT02939131|144524887|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.67|TWO_SIDED|95.0|-0.4|0.3|||t-test, 2 sided|||The average number of scheduled study visits through week 24 was computed for each site. The analysis was of these site-level averages. These values were compared between study groups||0.3|-0.4|0.67
72497483|NCT02939131|144524887|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.74|TWO_SIDED|95.0|-0.7|0.5|||t-test, 2 sided|||We computed the average number of scheduled study visits through week 48 for each site. We then averaged the site-level values and compared study groups.||0.5|-0.7|0.74
72497484|NCT02939131|144524888|SUPERIORITY||Mean Difference (Final Values)|-1.99||||0.14|TWO_SIDED|95.0|-4.74|0.76|||t-test, 2 sided||We subtracted the mean of the ESC group from the mean of the COMB-R group. Because a lower score indicated less severe depressive symptoms, a negative value indicated superiority.|We tested the null hypothesis that the treatment group means were equal vs. not.||0.76|-4.74|0.14
72619265|NCT00063232|144769204|SUPERIORITY_OR_OTHER|||||||0.04||95.0|||||paired t-test|||||||0.04
72619266|NCT03339453|144769205|NON_INFERIORITY|95% Confidence Interval of the treatment differences in treatment success rate.|Risk Difference (RD)|0.0|||||TWO_SIDED|95.0|-1.52|1.52||||||||1.52|-1.52|
72619267|NCT01027754|144769222|SUPERIORITY_OR_OTHER_LEGACY|||||||0.03|||||||Fisher Exact|||||||0.03
72619268|NCT01027754|144769223|SUPERIORITY_OR_OTHER_LEGACY|||||||0.24|||||||Fisher Exact|||||||0.24
72619269|NCT01027754|144769232|SUPERIORITY_OR_OTHER_LEGACY|||||||0.15|||||||Wilcoxon (Mann-Whitney)|||||||0.15
72497485|NCT02939131|144524889|SUPERIORITY||Mean Difference (Final Values)|25.3||||0.05|TWO_SIDED|95.0|0.5|50.0|||t-test, 2 sided||We subtracted the group mean of the site percents with response for the ESC group from that of the COMB-R group. A positive value indicates the COMB-R group had a higher mean percent of participants with response compared to the ESC group.|We tested the null hypothesis that the treatment group means were equal vs. not.||50.0|0.5|0.05
72497486|NCT02939131|144524890|SUPERIORITY||Mean Difference (Final Values)|16.3||||0.24|TWO_SIDED|95.0|-12.3|44.8|||t-test, 2 sided||We subtracted the group mean of the site percents with remission for the ESC group from the COMB-R group so a positive value indicates the COMB-R group has more participants with remission.|We tested the null hypothesis that the treatment group means were equal vs. not.||44.8|-12.3|0.24
72497487|NCT02939131|144524891|SUPERIORITY||Mean Difference (Final Values)|6.79||||0.01|TWO_SIDED|95.0|2.3|11.28||This is the test of effect modification by sex at birth|t-test, 2 sided||A positive value indicates that the treatment difference (lower QIDS-SR score with COMB-R than with ESC) was greater for females compared to males.|An interaction effect is computed based on subgroup differences within sites. The mean subgroup difference is computed for each treatment group and the interaction effect is the difference of those group mean differences. This is equivalent to taking the differences of the treatment effects between subgroups. Note: For QIDS-SR, since a lower score reflects fewer depression symptoms, a positive treatment effect is a negative difference value between groups.||11.28|2.30|0.01
72497488|NCT02939131|144524891|SUPERIORITY||Mean Difference (Final Values)|-2.56||||0.23|TWO_SIDED|95.0|-7.05|1.93||This is the test of effect modification by age group|t-test, 2 sided||A negative value indicates the treatment difference is greater for younger compared to older participants.|An interaction effect is computed based on subgroup differences within sites. The mean subgroup difference is computed for each treatment group and the interaction effect is the difference of those group mean differences.This is equivalent to taking the differences of the treatment effects between subgroups. Note: For QIDS-SR, since a lower score reflects fewer depression symptoms, a positive treatment effect is a negative difference value between groups.||1.93|-7.05|0.23
72497489|NCT02939131|144524891|SUPERIORITY||Mean Difference (Final Values)|-2.77||||0.31|TWO_SIDED|95.0|-8.48|2.95||This is the test of the effect modification of viral suppression status|t-test, 2 sided||A negative value indicates a greater treatment difference among those with viral suppression at study entry compared to those without viral suppression.|An interaction effect is computed based on subgroup differences within sites. The mean subgroup difference is computed for each treatment group and the interaction effect is the difference of those group mean differences.This is equivalent to taking the differences of the treatment effects between subgroups.Note: For QIDS-SR, since a lower score reflects fewer depression symptoms, a positive treatment effect is a negative difference value between groups.||2.95|-8.48|0.31
72497490|NCT02939131|144524891|SUPERIORITY||Mean Difference (Final Values)|0.83||||0.72|TWO_SIDED|95.0|-4.29|5.95||This is the test of effect modification by QIDS-SR depression level at study entry.|t-test, 2 sided||A positive value indicates a greater treatment difference among those with moderate levels of depression compared to severe depression.|An interaction effect is computed based on subgroup differences within sites. The mean subgroup difference is computed for each treatment group and the interaction effect is the difference of those group mean differences.This is equivalent to taking the differences of the treatment effects between subgroups.Note: For QIDS-SR, since a lower score reflects fewer depression symptoms, a positive treatment effect is a negative difference value between groups.||5.95|-4.29|0.72
72497491|NCT02939131|144524891|SUPERIORITY||Mean Difference (Final Values)|-0.3||||0.91|TWO_SIDED|95.0|-5.91|5.31||This is the test of effect modification by mode of transmission|t-test, 2 sided||A negative value would indicate a greater treatment difference for those with perinatal HIV acquisition compared to behavioral acquisition.|An interaction effect is computed based on subgroup differences within sites. The mean subgroup difference is computed for each treatment group and the interaction effect is the difference of those group mean differences.This is equivalent to taking the differences of the treatment effects between subgroups. Note: For QIDS-SR, since a lower score reflects fewer depression symptoms, a positive treatment effect is a negative difference value between groups.||5.31|-5.91|0.91
72497492|NCT02939131|144524891|SUPERIORITY||Mean Difference (Final Values)|1.33||||0.57|TWO_SIDED|95.0|-3.91|6.57||This is the test of effect modification by HIV CDC stage level|t-test, 2 sided||A positive value would indicate a greater treatment effect for those with less than HIV CDC Stage 3 compared to those with CDC Stage 3 HIV illness.|An interaction effect is computed based on subgroup differences within sites. The mean subgroup difference is computed for each treatment group and the interaction effect is the difference of those group mean differences.This is equivalent to taking the differences of the treatment effects between subgroups. Note: For QIDS-SR, since a lower score reflects fewer depression symptoms, a positive treatment effect is a negative difference value between groups.||6.57|-3.91|0.57
72497493|NCT02939131|144524891|SUPERIORITY||Mean Difference (Final Values)|5.93||||0.1|TWO_SIDED|95.0|-1.73|13.59||This is the test of effect modification of CD4 Stage 3 at entry.|t-test, 2 sided||A positive value indicates a greater treatment effect among those with less than Stage 3 CD4 count at entry compared to those with Stage 3 CD4 count.|An interaction effect is computed based on subgroup differences within sites. The mean subgroup difference is computed for each treatment group and the interaction effect is the difference of those group mean differences.This is equivalent to taking the differences of the treatment effects between subgroups. Note: For QIDS-SR, since a lower score reflects fewer depression symptoms, a positive treatment effect is a negative difference value between groups..||13.59|-1.73|0.10
72497494|NCT02939131|144524891|SUPERIORITY||Mean Difference (Final Values)|-1.57||||0.58|TWO_SIDED|95.0|-7.74|4.6||This is the test of effect modification by Nadir Stage 3 level at study entry.|t-test, 2 sided||A negative value indicates a greater treatment effect among those with Stage 3 Nadir CD4 compare to those with less than Stage 3 Nadir CD4.|An interaction effect is computed based on subgroup differences within sites. The mean subgroup difference is computed for each treatment group and the interaction effect is the difference of those group mean differences.This is equivalent to taking the differences of the treatment effects between subgroups. Note: For QIDS-SR, since a lower score reflects fewer depression symptoms, a positive treatment effect is a negative difference value between groups.||4.60|-7.74|0.58
72622395|NCT02702999|144774687|SUPERIORITY||Risk Ratio (RR)|5.4|||||TWO_SIDED|95.0|1.2|23.7|||||The intervention arm and control arm were compared using a log binomial (or Poisson in case of nonconvergence) model with the intervention arm as a covariate to estimate relative risk and 95% confidence interval (CI).|||23.7|1.2|
72445114|NCT03498651|144404981|SUPERIORITY||Mean Difference (Net)|-0.55|STANDARD_DEVIATION|0.02|||TWO_SIDED|95.0|-0.6|-0.51|||Mixed Models Analysis|We compared the two groups in a piecewise linear multilevel model (one slope during treatment, one during follow-up), controlling for income and age.|From the model (run in Bayesian with non-informative priors), we report the between-group SMD (with empirical SD \& 95% bootstrap confidence interval) at Session 5 (at mean income \& age), adjusted for baseline differences \& using pooled baseline SD.|"Intent-to-treat (ITT) analysis of Stage 1 randomization to CBM-I vs. psychoeducation. To correct for sampling bias (i.e., CBM-I, high attrition, coach received coaching, whereas psychoeducation did not receive coaching), CBM-I, high attrition, coach participants were excluded and replaced with an equal number of CBM-I, high attrition, no coach participants (using bootstrap resampling). The corrected ITT analysis sample included 1,234 participants (980 in CBM-I, 254 in psychoeducation)."||-0.51|-0.60|
72445115|NCT03498651|144404981|SUPERIORITY||Mean Difference (Net)|0.02|STANDARD_DEVIATION|0.13|||TWO_SIDED|95.0|-0.23|0.27|||Mixed Models Analysis|We compared the two groups in a piecewise linear multilevel model (one slope during treatment, one during follow-up), controlling for income and age.|From the model (run in Bayesian with non-informative priors), we report the between-group SMD (with empirical SD \& 95% HPD credible interval) at Session 5 (at mean income \& age), adjusted for baseline differences \& using pooled baseline SD.|"Analysis of Stage 2 randomization of CBM-I participants classified as high risk for attrition to supplemental coaching vs. no coaching. The analysis sample included 544 participants (263 in CBM-I, high attrition, no coach; 281 in CBM-I, high attrition, coach)."||0.27|-0.23|
72445116|NCT03498651|144404982|SUPERIORITY||Mean Difference (Net)|-0.41|STANDARD_DEVIATION|0.03|||TWO_SIDED|95.0|-0.46|-0.37|||Mixed Models Analysis|We compared the two groups in a piecewise linear multilevel model (one slope during treatment, one during follow-up), controlling for income and age.|From the model (run in Bayesian with non-informative priors), we report the between-group SMD (with empirical SD \& 95% bootstrap confidence interval) at Session 5 (at mean income \& age), adjusted for baseline differences \& using pooled baseline SD.|"Intent-to-treat (ITT) analysis of Stage 1 randomization to CBM-I vs. psychoeducation. To correct for sampling bias (i.e., CBM-I, high attrition, coach received coaching, whereas psychoeducation did not receive coaching), CBM-I, high attrition, coach participants were excluded and replaced with an equal number of CBM-I, high attrition, no coach participants (using bootstrap resampling). The corrected ITT analysis sample included 1,234 participants (980 in CBM-I, 254 in psychoeducation)."||-0.37|-0.46|
72445117|NCT03498651|144404982|SUPERIORITY||Mean Difference (Net)|0.05|STANDARD_DEVIATION|0.14|||TWO_SIDED|95.0|-0.23|0.32|||Mixed Models Analysis|We compared the two groups in a piecewise linear multilevel model (one slope during treatment, one during follow-up), controlling for income and age.|From the model (run in Bayesian with non-informative priors), we report the between-group SMD (with empirical SD \& 95% HPD credible interval) at Session 5 (at mean income \& age), adjusted for baseline differences \& using pooled baseline SD.|"Analysis of Stage 2 randomization of CBM-I participants classified as high risk for attrition to supplemental coaching vs. no coaching. The analysis sample included 544 participants (263 in CBM-I, high attrition, no coach; 281 in CBM-I, high attrition, coach)."||0.32|-0.23|
72445118|NCT03498651|144404983|SUPERIORITY||Mean Difference (Net)|-0.33|STANDARD_DEVIATION|0.03|||TWO_SIDED|95.0|-0.39|-0.27|||Mixed Models Analysis|We compared the two groups in a piecewise linear multilevel model (one slope during treatment, one during follow-up), controlling for income and age.|From the model (run in Bayesian with non-informative priors), we report the between-group SMD (with empirical SD \& 95% bootstrap confidence interval) at Session 5 (at mean income \& age), adjusted for baseline differences \& using pooled baseline SD.|"Intent-to-treat (ITT) analysis of Stage 1 randomization to CBM-I vs. psychoeducation. To correct for sampling bias (i.e., CBM-I, high attrition, coach received coaching, whereas psychoeducation did not receive coaching), CBM-I, high attrition, coach participants were excluded and replaced with an equal number of CBM-I, high attrition, no coach participants (using bootstrap resampling). The corrected ITT analysis sample included 1,234 participants (980 in CBM-I, 254 in psychoeducation)."||-0.27|-0.39|
72445119|NCT03498651|144404983|SUPERIORITY||Mean Difference (Net)|0.17|STANDARD_DEVIATION|0.16|||TWO_SIDED|95.0|-0.14|0.48|||Mixed Models Analysis|We compared the two groups in a piecewise linear multilevel model (one slope during treatment, one during follow-up), controlling for income and age.|From the model (run in Bayesian with non-informative priors), we report the between-group SMD (with empirical SD \& 95% HPD credible interval) at Session 5 (at mean income \& age), adjusted for baseline differences \& using pooled baseline SD.|"Analysis of Stage 2 randomization of CBM-I participants classified as high risk for attrition to supplemental coaching vs. no coaching. The analysis sample included 544 participants (263 in CBM-I, high attrition, no coach; 281 in CBM-I, high attrition, coach)."||0.48|-0.14|
72445120|NCT03138512|144405000|SUPERIORITY||Cox Proportional Hazard|0.95||||0.6676||95.0|0.75|1.2|||Log Rank|||||1.20|0.75|0.6676
72445121|NCT03138512|144405000|SUPERIORITY||Cox Proportional Hazard|0.93||||0.6556||95.0|0.67|1.28|||Log Rank|||||1.28|0.67|0.6556
72445122|NCT03138512|144405001|SUPERIORITY||Cox Proportional Hazard|1.26||||0.2436||95.0|0.85|1.85|||Log Rank|||Treatment Part A||1.85|0.85|0.2436
72445123|NCT03138512|144405001|SUPERIORITY||Cox Proportional Hazard|1.36||||0.45||95.0|0.61|3.07|||Log Rank|||Treatment Part B||3.07|0.61|0.4500
72445124|NCT03138512|144405003|SUPERIORITY||Cox Proportional Hazard|1.22|||||TWO_SIDED|95.0|0.89|1.67||||||||1.67|0.89|
72445125|NCT03138512|144405004|SUPERIORITY||Cox Proportional Hazard|0.75||||||95.0|0.33|1.68||||||||1.68|0.33|
72445126|NCT04382404|144405025|OTHER||Geometric mean ratio|0.85|||||TWO_SIDED|90.0|0.63|1.15|||||The pregnant cohort was the numerator, and the non-pregnant cohort was the denominator.|Maximum concentration of Velpatasvir in plasma was compared between the 10 pregnant women in this study to 25 non-pregnant historical control women. The geometric mean concentration (percent coefficient of variation) for the non-pregnant cohort was 449.39 (77.12).||1.15|0.63|
72497495|NCT02939131|144524892|SUPERIORITY||Mean Difference (Final Values)|-67.81||||0.01|TWO_SIDED|95.0|-116.53|-19.1||This is the test of effect modification by sex at birth.|t-test, 2 sided||A negative value indicates a greater treatment response (higher percent with response in COMB-R than in ESC group) among females compared to males.|An interaction effect is computed based on subgroup differences within sites. The mean subgroup difference is computed for each treatment group and the interaction effect is the difference of those group mean differences. This is equivalent to taking the differences of the treatment effects between subgroups. Note: For the percent of participants with QIDS-SR response, a positive treatment effect is a positive difference between groups.||-19.10|-116.53|0.01
72445127|NCT04382404|144405026|OTHER||Geometric mean ratio|1.19|||||TWO_SIDED|90.0|0.88|1.6|||||The pregnant cohort was the numerator, and the non-pregnant cohort was the denominator.|Maximum concentration of Sofosbuvir in plasma was compared between the 10 pregnant women in this study to 25 non-pregnant historical control women. The geometric mean concentration (percent coefficient of variation) for the non-pregnant cohort was 1226.16 (59.46).||1.60|0.88|
72445128|NCT04382404|144405027|OTHER||Geometric mean ratio|0.57|||||TWO_SIDED|90.0|0.49|0.67|||||The pregnant cohort was the numerator, and the non-pregnant cohort was the denominator.|Maximum concentration of GS-331007 in plasma was compared between the 10 pregnant women in this study to 25 non-pregnant historical control women. The geometric mean concentration (percent coefficient of variation) for the non-pregnant cohort was 1312.17 (32.55).||0.67|0.49|
72445129|NCT04382404|144405028|OTHER||Geometric mean ratio|0.91|||||TWO_SIDED|90.0|0.67|1.23|||||The pregnant cohort was the numerator, and the non-pregnant cohort was the denominator.|Area under the plasma concentration versus time curve tau of Velpatasvir was compared between the 10 pregnant women in this study to 25 non-pregnant historical control women. The geometric mean (percent coefficient of variation) for the non-pregnant cohort was 3570.65 (72.04).||1.23|0.67|
72445130|NCT04382404|144405029|OTHER||Geometric mean ratio|1.39|||||TWO_SIDED|90.0|1.06|1.78||||||Area under the plasma concentration versus time curve tau of Sofosbuvir was compared between the 10 pregnant women in this study to 25 non-pregnant historical control women. The geometric mean (percent coefficient of variation) for the non-pregnant cohort was 1483.83 (66.43).|The pregnant cohort was the numerator, and the non-pregnant cohort was the denominator.|1.78|1.06|
72445131|NCT04382404|144405030|OTHER||Geometric mean ratio|0.62|||||TWO_SIDED|90.0|0.55|0.71||||||Area under the plasma concentration versus time curve tau of Sofosbuvir was compared between the 10 pregnant women in this study to 25 non-pregnant historical control women. The geometric mean (percent coefficient of variation) for the non-pregnant cohort was 15361.31 (22.35).|The pregnant cohort was the numerator, and the non-pregnant cohort was the denominator.|0.71|0.55|
72445132|NCT04382404|144405031|OTHER||Geometric mean ratio|1.43|||||TWO_SIDED|95.0|0.91|2.25||||||The geometric mean (95 percent confidence interval) concentration of GS-461203 in peripheral blood mononuclear cells was compared between the pregnant cohort and 58 nonpregnant persons. The geometric mean (95 percent confidence interval) concentration of GS-461203 was 1474 (488, 4453) fmol /10\^6 cells in the nonpregnant cohort.|The pregnant cohort was the numerator, and the non-pregnant cohort was the denominator.|2.25|0.91|
72445133|NCT04382404|144405032|OTHER||Geometric mean ratio|1.91|||||TWO_SIDED|95.0|1.14|3.19|||||The pregnant cohort was the numerator, and the non-pregnant cohort was the denominator.|The geometric mean (95 percent confidence interval) concentration of GS-461203 in peripheral blood mononuclear cells was compared between the pregnant cohort and 58 nonpregnant persons. The geometric mean (95 percent confidence interval) concentration of GS-461203 was 1474 (488, 4453) fmol /10\^6 cells in the nonpregnant cohort.||3.19|1.14|
72445134|NCT04382404|144405033|OTHER||Geometric mean ratio|1.5|||||TWO_SIDED|95.0|0.87|2.6|||||The pregnant cohort was the numerator, and the non-pregnant cohort was the denominator.|The geometric mean (95 percent confidence interval) concentration of GS-461203 in peripheral blood mononuclear cells was compared between the pregnant cohort and 58 nonpregnant persons. The geometric mean (95 percent confidence interval) concentration of GS-461203 was 1474 (488, 4453) fmol /10\^6 cells in the nonpregnant cohort.||2.60|0.87|
72445135|NCT04382404|144405034|OTHER||Geometric mean ratio|0.53|||||TWO_SIDED|95.0|0.5|0.56|||||The pregnant cohort was the numerator, and the non-pregnant cohort was the denominator.|The geometric mean (95 percent confidence interval) concentration of GS-461203 in dried blood spots was compared between the pregnant cohort and 58 nonpregnant persons. The geometric mean (95 percent confidence interval) concentration of GS-461203 was 647 (571, 723) fmol/punch in the nonpregnant cohort.||.56|.50|
72445136|NCT04382404|144405035|OTHER||Geometric mean ratio|0.53|||||TWO_SIDED|95.0|0.49|0.58|||||The pregnant cohort was the numerator, and the non-pregnant cohort was the denominator.|The geometric mean (95 percent confidence interval) concentration of GS-461203 in dried blood spots was compared between the pregnant cohort and 58 nonpregnant persons. The geometric mean (95 percent confidence interval) concentration of GS-461203 was 647 (571, 723) fmol/punch in the nonpregnant cohort.||.58|.49|
72560671|NCT00830167|144651698|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.99|STANDARD_ERROR_OF_MEAN|1.92||0.0049|TWO_SIDED|95.0|-8.77|-1.21||The analysis was conducted using 1-sided test with the significance level of 0.025.|ANCOVA|||The null hypothesis was to assume that there was no difference between the pregabalin and placebo groups. The alternative was that the pregabalin group was superior to the placebo group.||-1.21|-8.77|0.0049
72445137|NCT04382404|144405036|OTHER||Geometric mean ratio|0.55|||||TWO_SIDED|95.0|0.48|0.64|||||The pregnant cohort was the numerator, and the non-pregnant cohort was the denominator.|The geometric mean (95 percent confidence interval) concentration of GS-461203 in dried blood spots was compared between the pregnant cohort and 58 nonpregnant persons. The geometric mean (95 percent confidence interval) concentration of GS-461203 was 647 (571, 723) fmol/punch in the nonpregnant cohort.||.64|.48|
72560672|NCT00830167|144651699|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.29|STANDARD_ERROR_OF_MEAN|0.09||0.0007|TWO_SIDED|95.0|0.11|0.47||The analysis was conducted using 1-sided test with the significance level of 0.025.|ANCOVA|||The null hypothesis was to assume that there was no difference between the pregabalin and placebo groups. The alternative was that the pregabalin group was superior to the placebo group.||0.47|0.11|0.0007
72560673|NCT00830167|144651700|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|7.48|STANDARD_ERROR_OF_MEAN|1.99|<|0.0001|TWO_SIDED|95.0|3.58|11.38||The analysis was conducted using 1-sided test with the significance level of 0.025.|ANCOVA|||The null hypothesis was to assume that there was no difference between the pregabalin and placebo groups. The alternative was that the pregabalin group was superior to the placebo group.||11.38|3.58|<0.0001
72560674|NCT00830167|144651701|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|11.31|STANDARD_ERROR_OF_MEAN|1.82||1|TWO_SIDED|95.0|7.74|14.87||The analysis was conducted using 1-sided test with the significance level of 0.025.|ANCOVA|||The null hypothesis was to assume that there was no difference between the pregabalin and placebo groups. The alternative was that the pregabalin group was superior to the placebo group.||14.87|7.74|1.0000
72445139|NCT05687916|144405072|SUPERIORITY||LS Mean Difference Estimate|-0.24|STANDARD_ERROR_OF_MEAN|3.277|=|0.989|TWO_SIDED|95.0|-6.67|6.18||The analysis used a linear MMRM with fixed effects for Baseline, age, prior use of narcolepsy medications, treatment, visit, and treatment-by-visit interaction as covariates. Reported p-value is adjusted for multiplicity.|MMRM|An unstructured variance-covariance structure was used.||||6.18|-6.67|=0.989
72445140|NCT05687916|144405072|SUPERIORITY||LS Mean Difference Estimate|2.4|STANDARD_ERROR_OF_MEAN|3.227|=|0.916|TWO_SIDED|95.0|-3.93|8.72||The analysis used a linear MMRM with fixed effects for Baseline, age, prior use of narcolepsy medications, treatment, visit, and treatment-by-visit interaction as covariates. Reported p-value is adjusted for multiplicity.|MMRM|An unstructured variance-covariance structure was used.||||8.72|-3.93|=0.916
72497496|NCT02939131|144524892|SUPERIORITY||Mean Difference (Final Values)|43.08||||0.09|TWO_SIDED|95.0|-8.23|94.38||This is the test of effect modification by age group.|t-test, 2 sided||A positive value reflects a greater treatment effect among younger participants compared to older participants.|An interaction effect is computed based on subgroup differences within sites. The mean subgroup difference is computed for each treatment group and the interaction effect is the difference of those group mean differences. This is equivalent to taking the differences of the treatment effects between subgroups. Note: For the percent of participants with QIDS-SR response, a positive treatment effect is a positive difference between groups.||94.38|-8.23|0.09
72497497|NCT02939131|144524892|SUPERIORITY||Mean Difference (Final Values)|2.18||||0.93|TWO_SIDED|95.0|-51.13|55.49||This is the test of effect modification by viral suppression status.|t-test, 2 sided||A positive value would reflect a greater treatment response among those with suppressed viral status at entry compared to those without viral suppression.|An interaction effect is computed based on subgroup differences within sites. The mean subgroup difference is computed for each treatment group and the interaction effect is the difference of those group mean differences. This is equivalent to taking the differences of the treatment effects between subgroups. Note: For the percent of participants with QIDS-SR response, a positive treatment effect is a positive difference between groups.||55.49|-51.13|0.93
72497498|NCT02939131|144524892|SUPERIORITY||Mean Difference (Final Values)|3.36||||0.87|TWO_SIDED|95.0|-42.28|49.0||This is the test of effect modification by entry QIDS-SR depression level.|t-test, 2 sided||A positive value would indicate a greater treatment response for those with severe depressive symptoms at study entry compared to those with moderate depression.|An interaction effect is computed based on subgroup differences within sites. The mean subgroup difference is computed for each treatment group and the interaction effect is the difference of those group mean differences. This is equivalent to taking the differences of the treatment effects between subgroups. Note: For the percent of participants with QIDS-SR response, a positive treatment effect is a positive difference between groups.||49.00|-42.28|0.87
72497499|NCT02939131|144524892|SUPERIORITY||Mean Difference (Final Values)|41.65||||0.17|TWO_SIDED|95.0|-21.91|105.2||This is the test of effect modification by mode of transmission.|t-test, 2 sided||A positive value would indicate a larger treatment response for those with perinatal transmission compared to behavioral.|An interaction effect is computed based on subgroup differences within sites. The mean subgroup difference is computed for each treatment group and the interaction effect is the difference of those group mean differences. This is equivalent to taking the differences of the treatment effects between subgroups. Note: For the percent of participants with QIDS-SR response, a positive treatment effect is a positive difference between groups.||105.20|-21.91|0.17
72497500|NCT02939131|144524892|SUPERIORITY||Mean Difference (Final Values)|49.4||||0.17|TWO_SIDED|95.0|-26.02|124.83||This is the test of effect modification by HIV CDC stage.|t-test, 2 sided||A positive value reflects a greater treatment response for those with HIV CDC Stage 3 classification compared to those with CDC classification less than Stage 3.|An interaction effect is computed based on subgroup differences within sites. The mean subgroup difference is computed for each treatment group and the interaction effect is the difference of those group mean differences. This is equivalent to taking the differences of the treatment effects between subgroups. Note: For the percent of participants with QIDS-SR response, a positive treatment effect is a positive difference between groups.||124.83|-26.02|0.17
72389499|NCT01751178|144286763|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.07|||<|0.0001|TWO_SIDED|95.0|-0.09|-0.05||From ANCOVA with factors for treatment group, site, smoking status, number of bleeding sites strata and the baseline GSI as a covariate.|ANCOVA||Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.|Null hypothesis stated that there was no difference between the two treatment groups.||-0.050|-0.090|<0.0001
72389500|NCT01751178|144286764|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.08|||<|0.0001|TWO_SIDED|95.0|-0.1|-0.05||From ANCOVA with factors for treatment group, site, smoking status, number of bleeding sites strata and the baseline GI as a covariate.|ANCOVA||Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.|Null hypothesis that there was no difference between the two treatment groups.||-0.05|-0.10|<0.0001
72389501|NCT01751178|144286764|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.08|||<|0.0001|TWO_SIDED|95.0|-0.11|-0.06||From ANCOVA with factors for treatment group, site, smoking status, number of bleeding sites strata and the baseline GI as a covariate.|ANCOVA||Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.|Null hypothesis stated that there was no difference between the two treatment groups.||-0.06|-0.11|<0.0001
72389502|NCT01751178|144286765|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.8|||<|0.0001|TWO_SIDED|95.0|-0.98|-0.62||From ANCOVA with factors for treatment group, site, smoking status, number of bleeding sites strata and the baseline Plaque as a covariate|ANCOVA||Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.|Null hypothesis stated that there was no difference between the two treatment groups in Overall Plaque scores.||-0.62|-0.98|<0.0001
72389503|NCT01751178|144286765|SUPERIORITY_OR_OTHER||Adusted Mean Difference|-0.86|||<|0.0001|TWO_SIDED|95.0|-1.04|-0.68||From ANCOVA with factors for treatment group, site, smoking status, number of bleeding sites strata and the baseline Plaque as a covariate|ANCOVA||Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.|Null hypothesis stated that there was no difference between the two treatment groups in Overall Plaque Scores.||-0.68|-1.04|<0.0001
72497501|NCT02939131|144524892|SUPERIORITY||Mean Difference (Final Values)|11.69||||0.71|TWO_SIDED|95.0|-70.76|94.15||This is the test of effect modification by CD4 Stage at study entry.|t-test, 2 sided||A positive value would reflect greater treatment response for those with CD4 Stage 3 compared to those with less than Stage 3 CD4.|An interaction effect is computed based on subgroup differences within sites. The mean subgroup difference is computed for each treatment group and the interaction effect is the difference of those group mean differences. This is equivalent to taking the differences of the treatment effects between subgroups. Note: For the percent of participants with QIDS-SR response, a positive treatment effect is a positive difference between groups.||94.15|-70.76|0.71
72497502|NCT02939131|144524892|SUPERIORITY||Mean Difference (Final Values)|52.48||||0.02|TWO_SIDED|95.0|10.46|94.5||This is the test of effect modification by CD4 Nadir stage at study entry.|t-test, 2 sided||A positive value reflects a larger treatment response among those with Stage 3 Nadir CD4 compared to those with less than Stage 3 Nadir CD4.|An interaction effect is computed based on subgroup differences within sites. The mean subgroup difference is computed for each treatment group and the interaction effect is the difference of those group mean differences. This is equivalent to taking the differences of the treatment effects between subgroups. Note: For the percent of participants with QIDS-SR response, a positive treatment effect is a positive difference between groups.||94.50|10.46|0.02
72497503|NCT02939131|144524893|SUPERIORITY||Mean Difference (Final Values)|-45.06||||0.09|TWO_SIDED|95.0|-97.84|7.72||This is the test of effect modification by sex at birth|t-test, 2 sided||A negative value indicates a greater treatment effect (higher percent with remission for COMB-R than for ESC) among females.|An interaction effect is computed based on subgroup differences within sites. The mean subgroup difference is computed for each treatment group and the interaction effect is the difference of those group mean differences. This is equivalent to taking the differences of the treatment effects between subgroups. Note: For the percent of participants with QIDS-SR remission, a positive treatment effect is a positive difference between groups.||7.72|-97.84|0.09
72497504|NCT02939131|144524893|SUPERIORITY||Mean Difference (Final Values)|1.41||||0.95|TWO_SIDED|95.0|-43.38|46.2||This is the test of effect modification by age group.|t-test, 2 sided||A positive value would reflect a larger treatment effect among younger participants compared to older participants.|An interaction effect is computed based on subgroup differences within sites. The mean subgroup difference is computed for each treatment group and the interaction effect is the difference of those group mean differences. This is equivalent to taking the differences of the treatment effects between subgroups. Note: For the percent of participants with QIDS-SR remission, a positive treatment effect is a positive difference between groups.||46.20|-43.38|0.95
72497505|NCT02939131|144524893|SUPERIORITY||Mean Difference (Final Values)|5.59||||0.79|TWO_SIDED|95.0|-40.47|51.65||This is the test of effect modification by viral suppression status.|Wilcoxon (Mann-Whitney)||A positive value would reflect a greater treatment effect among those with suppressed viral load compared to those without viral suppression.|An interaction effect is computed based on subgroup differences within sites. The mean subgroup difference is computed for each treatment group and the interaction effect is the difference of those group mean differences. This is equivalent to taking the differences of the treatment effects between subgroups. Note: For the percent of participants with QIDS-SR remission, a positive treatment effect is a positive difference between groups.||51.65|-40.47|0.79
72497506|NCT02939131|144524893|SUPERIORITY||Mean Difference (Final Values)|-15.97||||0.42|TWO_SIDED|95.0|-58.88|26.94||This is the test of effect modification by QIDS-SR level at entry.|t-test, 2 sided||A negative value would reflect a greater treatment effect among those with moderate depression symptomatology at entry compared to those with severe depression.|An interaction effect is computed based on subgroup differences within sites. The mean subgroup difference is computed for each treatment group and the interaction effect is the difference of those group mean differences. This is equivalent to taking the differences of the treatment effects between subgroups. Note: For the percent of participants with QIDS-SR remission, a positive treatment effect is a positive difference between groups.||26.94|-58.88|0.42
72497507|NCT02939131|144524893|SUPERIORITY||Mean Difference (Final Values)|9.99||||0.68|TWO_SIDED|95.0|-41.24|61.22||This is the test of effect modification by mode of transmission.|t-test, 2 sided||A positive value would reflect a greater treatment effect among those with perinatal transmission compared to behavioral transmission.|An interaction effect is computed based on subgroup differences within sites. The mean subgroup difference is computed for each treatment group and the interaction effect is the difference of those group mean differences. This is equivalent to taking the differences of the treatment effects between subgroups. Note: For the percent of participants with QIDS-SR remission, a positive treatment effect is a positive difference between groups.||61.22|-41.24|0.68
72497508|NCT02939131|144524893|SUPERIORITY||Mean Difference (Final Values)|-14.21||||0.57|TWO_SIDED|95.0|-70.62|42.2||This is the test of effect modification by HIV CDC stage.|t-test, 2 sided||A positive value would reflect a greater treatment response among those with HIV CDC Stage 3 classification compared to those with less than Stage 3 classification.|An interaction effect is computed based on subgroup differences within sites. The mean subgroup difference is computed for each treatment group and the interaction effect is the difference of those group mean differences. This is equivalent to taking the differences of the treatment effects between subgroups. Note: For the percent of participants with QIDS-SR remission, a positive treatment effect is a positive difference between groups.||42.20|-70.62|0.57
72497509|NCT02939131|144524893|SUPERIORITY||Mean Difference (Final Values)|-44.97||||0.26|TWO_SIDED|95.0|-141.12|51.17||This is the test of effect modification by CD4 Stage.|t-test, 2 sided||A negative value would reflect a greater treatment effect among those with less than Stage 3 CD4 levels compared to those with Stage 3 CD4.|An interaction effect is computed based on subgroup differences within sites. The mean subgroup difference is computed for each treatment group and the interaction effect is the difference of those group mean differences. This is equivalent to taking the differences of the treatment effects between subgroups. Note: For the percent of participants with QIDS-SR remission, a positive treatment effect is a positive difference between groups.||51.17|-141.12|0.26
72389504|NCT01751178|144286766|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.88|||<|0.0001|TWO_SIDED|95.0|-1.07|-0.69||From ANCOVA with factors for treatment group, site, smoking status, number of bleeding sites strata and the baseline Plaque as a covariate|ANCOVA||Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.|Null hypotheses stated that there was no difference between the two treatments.||-0.69|-1.07|<0.0001
72619270|NCT01654250|144769239|SUPERIORITY_OR_OTHER||Least Square(LS) Mean Difference|-7.0|STANDARD_ERROR_OF_MEAN|1.99|<|0.001|TWO_SIDED|95.0|-10.9|-3.1|||Mixed Models Analysis|||Treatment comparisons for observed scores were assessed using a mixed model repeated measures analysis, with treatment (NWP09/Placebo), study center, time point, and time point by treatment interaction as main effects and participant intercept as a random effect.||-3.1|-10.9|<0.001
72389505|NCT01751178|144286766|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.97|||<|0.0001|TWO_SIDED|95.0|-1.16|-0.78||From ANCOVA with factors for treatment group, site, smoking status, number of bleeding sites strata and the baseline Plaque as a covariate|ANCOVA||Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.|Null hypotheses stated that there was no difference between the two groups.||-0.78|-1.16|<0.0001
72389506|NCT00621582|144286794|SUPERIORITY_OR_OTHER|||||||0.01||95.0|||||Chi-squared|||comparing results of post-treatment global assessment by patient with that of pre-treatment||||0.01
72389507|NCT00963937|144286810|SUPERIORITY_OR_OTHER||Percent Difference|-7.49||||0.345|TWO_SIDED|95.0|-23.02|8.04||Multiplicity was not considered because the primary analysis included a single statistical comparison.|Chi-squared||Percent difference = sumatriptan pooled group minus the placebo group|||8.04|-23.02|0.345
72389508|NCT04010695|144286836|OTHER||||||<|0.001|||||||K-sample test|The p-value was calculated using a nonparametric k-sample test on the equality of medians.||Comparison of SD Biosensor POC G6PD test results for capillary and venous samples||||<0.001
72389509|NCT00389597|144286837|NON_INFERIORITY_OR_EQUIVALENCE|The 95% one-sided confidence bound for testing non-inferiority using two proportion test with 10% non-inferiority margin.||||||0.0021|||||||Farrington Manning|||1 Level: Ho: pm-pc \<=-0.1 (inferiority) Alternative hypothesis: Ha: pm - pc \> -0.1 Where pm = the proportion of success in the Mobi-C group and the Pc = the proportion of success in the ACDF group.||||0.0021
72389510|NCT00389597|144286837|NON_INFERIORITY_OR_EQUIVALENCE|The 95% one-sided confidence bound for testing non-inferiority using two proportioned test with a 10% non-inferiority margin.|||||<|0.0001|||||||Farrington-Manning|||"2 Level: Ho: pm-pc \<=-0.1 (inferiority) Alternative hypothesis: Ha: pm - pc \> -0.1 Where pm = the proportion of success in the Mobi-C group and the Pc = the proportion of success in the ACDF group.~2 Level: Ho: pm-pc \<= 0 (not superior) Alternative hypothesis: Ha: pm-pc \>0 Where pm = the proportion of success in the Mobi-C group and the Pc = the proportion of success in the ACDF group."||||<0.0001
72389511|NCT02021773|144286839|SUPERIORITY||Mean Difference (Final Values)|-22.74|STANDARD_ERROR_OF_MEAN|10.937||0.0386|TWO_SIDED|95.0|-44.28|-1.21||The threshold for statistical significance was p = .05.|Mixed Models Analysis|||||-1.21|-44.28|0.0386
72389512|NCT02021773|144286839|SUPERIORITY||Mean Difference (Final Values)|-30.41|STANDARD_ERROR_OF_MEAN|10.9||0.0057|TWO_SIDED|95.0|-51.88|-8.95||The threshold for statistical significance was p = .05.|Mixed Models Analysis|||||-8.95|-51.88|0.0057
72389513|NCT00087607|144286855|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.01||||0.978|TWO_SIDED|95.0|-0.35|0.36|||t-test, 2 sided|||Mean treatment difference was tested using a two-sided t-test.||0.36|-0.35|0.978
72389514|NCT00087607|144286856|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.27||||0.08|TWO_SIDED|95.0|-0.03|0.58|||t-test, 2 sided|||At Week 4: Mean treatment difference was tested using a two-sided t-test.||0.58|-0.03|0.080
72389515|NCT00087607|144286856|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.07||||0.688|TWO_SIDED|95.0|-0.27|0.41|||t-test, 2 sided|||At Week 8: Mean treatment difference was tested using a two-sided t-test.||0.41|-0.27|0.688
72389516|NCT00087607|144286860|SUPERIORITY_OR_OTHER|||||||0.304|TWO_SIDED||||||ANOVA|||The treatment groups were compared using an analysis of variance (ANOVA) with treatment as the only factor in the model.||||0.304
72389517|NCT00087607|144286862|SUPERIORITY_OR_OTHER||Difference in proportion of participants|-3.1||||0.2814|TWO_SIDED|95.0|-8.6|2.5|||Chi-squared|||Week 1: Treatment groups were compared using the Chi-Square Test.||2.5|-8.6|0.2814
72389518|NCT00087607|144286862|SUPERIORITY_OR_OTHER||Difference in proportion of participants|-10.3||||0.0214|TWO_SIDED|95.0|-18.9|-1.6|||Chi-squared|||Week 2: Treatment groups were compared using the Chi-Square Test.||-1.6|-18.9|0.0214
72389519|NCT00087607|144286862|SUPERIORITY_OR_OTHER||Difference in proportion of participants|-10.7||||0.0315|TWO_SIDED|95.0|-20.3|-1.0|||Chi-squared|||Week 3: Treatment groups were compared using the Chi-Square Test.||-1.0|-20.3|0.0315
72389520|NCT00087607|144286862|SUPERIORITY_OR_OTHER||Difference in proportion of participants|-7.4||||0.1467|TWO_SIDED|95.0|-17.4|2.6|||Chi-squared|||Week 4: Treatment groups were compared using the Chi-Square Test.||2.6|-17.4|0.1467
72389521|NCT00087607|144286862|SUPERIORITY_OR_OTHER||Difference in proportion of participants|-6.8||||0.1823|TWO_SIDED|95.0|-16.9|3.2|||Chi-squared|||Week 5: Treatment groups were compared using the Chi-Square Test.||3.2|-16.9|0.1823
72389522|NCT00087607|144286862|SUPERIORITY_OR_OTHER||Difference in proportion of participants|-2.1||||0.6871|TWO_SIDED|95.0|-12.1|8.0|||Chi-squared|||Week 6: Treatment groups were compared using the Chi-Square Test.||8.0|-12.1|0.6871
72389523|NCT00087607|144286862|SUPERIORITY_OR_OTHER||Difference in proportion of participants|-0.4||||0.9295|TWO_SIDED|95.0|-10.4|9.5|||Chi-squared|||Week 7: Treatment groups were compared using the Chi-Square Test.||9.5|-10.4|0.9295
72389524|NCT00087607|144286862|SUPERIORITY_OR_OTHER||Difference in proportion of participants|2.2||||0.6593|TWO_SIDED|95.0|-7.6|12.1|||Chi-squared|||Week 8: Treatment groups were compared using the Chi-Square Test.||12.1|-7.6|0.6593
72389525|NCT00087607|144286862|SUPERIORITY_OR_OTHER||Difference in proportion of participants|2.2||||0.6637|TWO_SIDED|95.0|-7.7|12.1|||Chi-squared|||Week 9: Treatment groups were compared using the Chi-Square Test.||12.1|-7.7|0.6637
72389526|NCT00087607|144286862|SUPERIORITY_OR_OTHER||Difference in proportion of participants|5.4||||0.276|TWO_SIDED|95.0|-4.3|15.1|||Chi-squared|||Week 10: Treatment groups were compared using the Chi-Square Test.||15.1|-4.3|0.2760
72389527|NCT00087607|144286862|SUPERIORITY_OR_OTHER||Difference in proportion of participants|5.4||||0.2779|TWO_SIDED|95.0|-4.3|15.1|||Chi-squared|||Week 11: Treatment groups were compared using the Chi-Square Test.||15.1|-4.3|0.2779
72389528|NCT00087607|144286862|SUPERIORITY_OR_OTHER||Difference in proportion of participants|2.8||||0.5697|TWO_SIDED|95.0|-6.8|12.4|||Chi-squared|||Week 12: Treatment groups were compared using the Chi-Square Test.||12.4|-6.8|0.5697
72622396|NCT02702999|144774688|SUPERIORITY||Risk Ratio (RR)|0.2|||||TWO_SIDED|95.0|0.03|2.1|||||The intervention arm and control arm were compared using a log binomial (or Poisson in case of nonconvergence) model with the intervention arm as a covariate to estimate relative risk and 95% confidence interval (CI).|||2.1|0.03|
72497510|NCT02939131|144524893|SUPERIORITY||Mean Difference (Final Values)|9.53||||0.72|TWO_SIDED|95.0|-52.97|72.02||This is the test of effect modification by CD4 nadir stage.|t-test, 2 sided||A positive value would reflect a greater treatment effect by those with Stage 3 CD4 Nadir compared to those with less than Stage 3.|An interaction effect is computed based on subgroup differences within sites. The mean subgroup difference is computed for each treatment group and the interaction effect is the difference of those group mean differences. This is equivalent to taking the differences of the treatment effects between subgroups. Note: For the percent of participants with QIDS-SR remission, a positive treatment effect is a positive difference between groups.||72.02|-52.97|0.72
72497511|NCT02939131|144524894|SUPERIORITY||Mean Difference (Final Values)|9.9||||0.26|TWO_SIDED|95.0|-8.4|28.1|||t-test, 2 sided||A positive value would indicate site-level percentages were higher in the COMB-R group and vice versa.|The percent of participants with alcohol use ever at week 24 were computed for each site. These site-level percentages were compared across treatment groups.||28.1|-8.4|0.26
72497512|NCT02939131|144524894|SUPERIORITY||Mean Difference (Final Values)|-6.3||||0.66|TWO_SIDED|95.0|-37.1|24.6|||t-test, 2 sided||A positive value would indicate site-level percentages were higher in the COMB-R group and vice versa.|The percent of participants with alcohol use ever at week 48 were computed for each site. These site-level percentages were compared across treatment groups.||24.6|-37.1|0.66
72497513|NCT02939131|144524895|SUPERIORITY||Mean Difference (Final Values)|4.7||||0.71|TWO_SIDED|95.0|-22.3|31.7|||t-test, 2 sided||A positive value indicates higher site-level percentages in the COMB-R group.|The percent of participants with regular frequency alcohol use at week 24 were computed for each site. These site-level percentages were compared across treatment groups.||31.7|-22.3|0.71
72497514|NCT02939131|144524895|SUPERIORITY||Mean Difference (Final Values)|26.7||||0.1|TWO_SIDED|95.0|-6.3|59.6|||t-test, 2 sided||A positive value would indicate higher site-level percentages in the COMB-R group.|The percent of participants at each site with regular alcohol use at week 48 was computed. These site-level percents were compared across treatments||59.6|-6.3|0.10
72497515|NCT02939131|144524896|SUPERIORITY||Mean Difference (Final Values)|-1.2||||0.09|TWO_SIDED|95.0|-2.6|0.2|||t-test, 2 sided||A positive value would indicate site level averages were higher in the COMB-R group and vice versa.|The average number of drinks per day reported at week 24 was computed for each site and these site-level averages were compared across treatments.||0.2|-2.6|0.09
72497516|NCT02939131|144524896|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.79|TWO_SIDED|95.0|-0.8|1.0|||t-test, 2 sided||A positive value would indicate site level averages were higher in the COMB-R group and vice versa.|The site-level average numbers of drinks per day reported at week 48 were computed and these site-level averages were compared across treatment groups.||1.0|-0.8|0.79
72560675|NCT00830167|144651702|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.99|STANDARD_ERROR_OF_MEAN|1.35||0.0137|TWO_SIDED|95.0|-5.65|-0.33||The analysis was conducted using 1-sided test with the significance level of 0.025.|ANCOVA|||The null hypothesis was to assume that there was no difference between the pregabalin and placebo groups. The alternative was that the pregabalin group was superior to the placebo group.||-0.33|-5.65|0.0137
72619271|NCT01654250|144769240|SUPERIORITY_OR_OTHER||LS Mean Difference|-8.2|STANDARD_ERROR_OF_MEAN|2.28|<|0.001|TWO_SIDED|95.0|-12.7|-3.7|||Mixed Models Analysis|||Hour 0.75 post-dose: Nominal p value-treatment comparisons for observed scores were assessed using a mixed model repeated measures analysis, with treatment (NWP09/Placebo), study center, time point and time point by treatment interaction as main effects and participant intercept as a random effect.||-3.7|-12.7|<0.001
72389529|NCT00087607|144286863|SUPERIORITY_OR_OTHER||Difference in proportion of participants|0.0||||0.994|TWO_SIDED|95.0|-1.4|1.5|||Chi-squared|||Week 1: Treatment groups were compared using the Chi-Square Test.||1.5|-1.4|0.9940
72497517|NCT02939131|144524897|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.87|TWO_SIDED|95.0|-0.9|0.8|||t-test, 2 sided||A positive value would indicate site level averages were higher in the COMB-R group anc vice versa|The site-level average number of days with binge drinking at week 24 were computed and these site-level averages were compared across treatments.||0.8|-0.9|0.87
72497518|NCT02939131|144524897|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.99|TWO_SIDED|95.0|-0.8|0.8|||t-test, 2 sided||A positive difference would indicate site level averages were higher in the COMB-R group and vice versa|The site-level average number of days with binge drinking reported at week 48 were computed and the site-level averages were compared across treatment groups.||0.8|-0.8|0.99
72497519|NCT02939131|144524898|SUPERIORITY||Mean Difference (Final Values)|3.2||||0.77|TWO_SIDED|95.0|-19.7|26.0|||t-test, 2 sided||A positive value would indicate site-level percentages were higher in the COMB-R group and vice versa.|The percent of participants with tobacco use ever at week 24 were computed for each site. These site-level percentages were compared across treatment groups.||26.0|-19.7|0.77
72497520|NCT02939131|144524898|SUPERIORITY||Mean Difference (Final Values)|14.7||||0.2|TWO_SIDED|95.0|-8.9|38.4|||t-test, 2 sided||A positive value would indicate site-level percentages were higher in the COMB-R group.|The percent of participants with tobacco use ever at week 48 were computed for each site. These site-level percentages were compared across treatment groups.||38.4|-8.9|0.20
72560676|NCT00830167|144651703|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.45||||0.0687|TWO_SIDED|95.0|0.9|2.35||The analysis was conducted using 1-sided test with the significance level of 0.025.|Regression, Logistic|||The null hypothesis was to assume that there was no difference between the pregabalin and placebo groups. The alternative was that the pregabalin group was superior to the placebo group.||2.35|0.90|0.0687
72560677|NCT00830167|144651704|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.73|STANDARD_ERROR_OF_MEAN|0.17|<|0.0001|TWO_SIDED|95.0|-1.06|-0.4||The analysis was conducted using 1-sided test with the significance level of 0.025.|ANCOVA|||The null hypothesis was to assume that there was no difference between the pregabalin and placebo groups. The alternative was that the pregabalin group was superior to the placebo group.||-0.40|-1.06|<0.0001
72619272|NCT01654250|144769240|SUPERIORITY_OR_OTHER|||||||0.133|||||||Mixed Models Analysis|||Hour 0.75 post-dose: Adjusted p-values were generated using a fixed sequence testing procedure from p-values which were generated from the mixed effects model.||||0.133
72622397|NCT02702999|144774689|SUPERIORITY||Risk Ratio (RR)|1.0|||||TWO_SIDED|95.0|0.4|2.3|||||The intervention arm and control arm were compared using a log binomial (or Poisson in case of nonconvergence) model with the intervention arm as a covariate to estimate relative risk and 95% confidence interval (CI).|||2.3|0.4|
72497521|NCT02939131|144524899|SUPERIORITY||Mean Difference (Final Values)|15.2||||0.09|TWO_SIDED|95.0|-2.8|33.3|||t-test, 2 sided||A positive difference would indicate the site level percentages were higher in the COMB-R group.|This is the analysis of regular use of tobacco at week 24. The percent of participants at each site with regular use was computed. These site-level percentages were compared across treatment groups.||33.3|-2.8|0.09
72497522|NCT02939131|144524899|SUPERIORITY||Mean Difference (Final Values)|20.6||||0.21|TWO_SIDED|95.0|-14.0|55.3|||t-test, 2 sided||A positive difference indicates site-level percentages were higher in the COMB-R group.|This is the analysis of regular frequency use of tobacco at week 48. Site level percentages of the numbers of participants with regular tobacco use were computed and compared across treatment groups.||55.3|-14.0|0.21
72497523|NCT02939131|144524900|SUPERIORITY||Mean Difference (Final Values)|7.9||||0.41|TWO_SIDED|95.0|-12.4|28.3|||t-test, 2 sided||A positive value would indicate higher site-level percentages in the COMB-R group and vice versa.|The site-level percentages of participants ever using marijuana (cannabis) reported at week 24 were computed and compared across treatment groups.||28.3|-12.4|0.41
72497524|NCT02939131|144524900|SUPERIORITY||Mean Difference (Final Values)|13.0||||0.26|TWO_SIDED|95.0|-10.9|36.8|||t-test, 2 sided||A positive value would indicate higher site-level percentages in the COMB-R group and vice versa.|The site-level percentages of participants ever using marijuana (cannabis) reported at week 48 were computed and compared across treatment groups.||36.8|-10.9|0.26
72497525|NCT02939131|144524900|SUPERIORITY||Mean Difference (Final Values)|4.7||||0.69|TWO_SIDED|95.0|-20.2|29.5|||t-test, 2 sided||A positive difference would indicate higher site-level percentages in the COMB-R group and vice versa.|The site-level percentages of participants ever using any illegal substance excluding marijuana (cannabis) reported at week 24 were computed and compared across treatment groups.||29.5|-20.2|0.69
72389530|NCT00087607|144286863|SUPERIORITY_OR_OTHER||Difference in proportion of participants|-0.5||||0.7133|TWO_SIDED|95.0|-3.2|2.2|||Chi-squared|||Week 2: Treatment groups were compared using the Chi-Square Test.||2.2|-3.2|0.7133
72389531|NCT00087607|144286863|SUPERIORITY_OR_OTHER||Difference in proportion of participants|-3.6||||0.0864|TWO_SIDED|95.0|-7.8|0.5|||Chi-squared|||Week 3: Treatment groups were compared using the Chi-Square Test.||0.5|-7.8|0.0864
72389532|NCT00087607|144286863|SUPERIORITY_OR_OTHER||Difference in proportion of participants|-4.1||||0.1713|TWO_SIDED|95.0|-10.0|1.8|||Chi-squared|||Week 4: Treatment groups were compared using the Chi-Square Test.||1.8|-10.0|0.1713
72389533|NCT00087607|144286863|SUPERIORITY_OR_OTHER||Difference in proportion of participants|-4.6||||0.1888|TWO_SIDED|95.0|-11.4|2.2|||Chi-squared|||Week 5: Treatment groups were compared using the Chi-Square Test.||2.2|-11.4|0.1888
72389534|NCT00087607|144286863|SUPERIORITY_OR_OTHER||Difference in proportion of participants|-6.6||||0.108|TWO_SIDED|95.0|-14.7|1.4|||Chi-squared|||Week 6: Treatment groups were compared using the Chi-Square Test.||1.4|-14.7|0.1080
72389535|NCT00087607|144286863|SUPERIORITY_OR_OTHER||Difference in proportion of participants|-4.5||||0.3099|TWO_SIDED|95.0|-13.1|4.2|||Chi-squared|||Week 7: Treatment groups were compared using the Chi-Square Test.||4.2|-13.1|0.3099
72389536|NCT00087607|144286863|SUPERIORITY_OR_OTHER||Difference in proportion of participants|-3.4||||0.4595|TWO_SIDED|95.0|-12.4|5.6|||Chi-squared|||Week 8: Treatment groups were compared using the Chi-Square Test.||5.6|-12.4|0.4595
72389537|NCT00087607|144286863|SUPERIORITY_OR_OTHER||Difference in proportion of participants|-6.0||||0.2144|TWO_SIDED|95.0|-15.4|3.4|||Chi-squared|||Week 9: Treatment groups were compared using the Chi-Square Test.||3.4|-15.4|0.2144
72389538|NCT00087607|144286863|SUPERIORITY_OR_OTHER||Difference in proportion of participants|-5.4||||0.2779|TWO_SIDED|95.0|-15.1|4.3|||Chi-squared|||Week 10: Treatment groups were compared using the Chi-Square Test.||4.3|-15.1|0.2779
72389539|NCT00087607|144286863|SUPERIORITY_OR_OTHER||Difference in proportion of participants|-2.7||||0.5876|TWO_SIDED|95.0|-12.6|7.1|||Chi-squared|||Week 11: Treatment groups were compared using the Chi-Square Test.||7.1|-12.6|0.5876
72389540|NCT00087607|144286863|SUPERIORITY_OR_OTHER||Difference in proportion of participants|-4.8||||0.3399|TWO_SIDED|95.0|-14.7|5.1|||Chi-squared|||Week 12: Treatment groups were compared using the Chi-Square Test.||5.1|-14.7|0.3399
72389541|NCT00087607|144286868|SUPERIORITY_OR_OTHER|||||||0.024|TWO_SIDED||||||Repeated measures analysis|The P-value is determined from a repeated measures analysis with terms for treatment group, baseline, week, and the week-by-treatment interaction.||Week 1: The treatment groups were compared using repeated measures analysis||||0.024
72389542|NCT00087607|144286868|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Repeated measures analysis|||Week 8: The treatment groups were compared using Repeated measures analysis||||<0.001
72389543|NCT02015754|144286904|OTHER|||||||0.004||||||Differences of p-value \< 0.05 considered statistically significant.|Regression, Cox|||Multivariate Cox-regression analysis to identify independent prognostic factors for overall survival from baseline characteristics. Relative risk with 95% confidence intervals calculated as measure of association.||||0.004
72389544|NCT02015754|144286911|OTHER|VEGF immediately post treatment||||||0.6257|||||||one-sample Wilcoxon signed rank test|||||||0.6257
72389545|NCT02015754|144286911|OTHER|VEGF at 24 hours post treatment.||||||0.4143|||||||one-sample Wilcoxon signed rank test|||||||0.4143
72389546|NCT02015754|144286911|OTHER|VEGFR1 immediately post treatment.||||||0.583|||||||one-sample Wilcoxon signed rank test|||||||0.583
72389547|NCT02015754|144286911|OTHER|VEGFR1 at 24 hours post treatment.||||||0.0012|||||||one-sample Wilcoxon signed rank test|||||||.0012
72389548|NCT02015754|144286911|OTHER|VEGFR2 immediately post treatment.||||||0.1353|||||||one-sample Wilcoxon signed rank test|||||||0.1353
72389549|NCT02015754|144286911|OTHER|VEGFR2 at 24 hours post treatment.||||||0.2163|||||||one-sample Wilcoxon signed rank test|||||||0.2163
72389550|NCT00668707|144287000|SUPERIORITY||Risk Ratio (RR)|1.01||||0.94|TWO_SIDED|95.0|0.83|1.22|||Regression, Logistic|||Analysis conducted was an adjusted logistic regression (adjuvant chemotherapy, adjuvant radiation, smoking history). Results were presented as a relative risk. Based on an estimated 30% outcome rate of recurrence or mortality in the control arm, 294 participants per arm provided 80% power to detect a relative risk of one third at an alpha of 0.05. We inflated this sample size to 346 per arm to account for 15% lost to follow-up.||1.22|0.83|0.94
72445141|NCT05687916|144405073|SUPERIORITY||LS Mean Difference Estimate|-0.32|STANDARD_ERROR_OF_MEAN|1.656|=|0.989|TWO_SIDED|95.0|-3.57|2.92||The analysis used a linear MMRM with fixed effects for Baseline, age, prior use of narcolepsy medications, treatment, visit, and treatment-by-visit interaction as covariates. Reported p-value is adjusted for multiplicity.|MMRM|An unstructured variance-covariance structure was used.|LS in LS Mean Difference denotes least squares.|||2.92|-3.57|=0.989
72445142|NCT05687916|144405073|SUPERIORITY||LS Mean Difference Estimate|-3.06|STANDARD_ERROR_OF_MEAN|1.59|=|0.216|TWO_SIDED|95.0|-6.18|0.06||The analysis used a linear MMRM with fixed effects for Baseline, age, prior use of narcolepsy medications, treatment, visit, and treatment-by-visit interaction as covariates. Reported p-value is adjusted for multiplicity.|MMRM|An unstructured variance-covariance structure was used.||||0.06|-6.18|=0.216
72445143|NCT03332017|144405075|SUPERIORITY|||||||0.0017|||||||Cochran-Mantel-Haenszel|P-value was stratified by rituximab-refractory status, number of prior lines of therapy, and geographic region per interactive response technology.||||||0.0017
72445144|NCT04401800|144405124|SUPERIORITY|||||||0.0002|||||||Binomial exact test|||||||0.0002
72445145|NCT04401800|144405126|SUPERIORITY||||||<|0.0001|||||||Binomial exact test|||||||< 0.0001
72445146|NCT04401800|144405127|SUPERIORITY||||||<|0.0001|||||||Binomial exact test|||ORR as Assessed by the Investigator||||< 0.0001
72445147|NCT04401800|144405127|SUPERIORITY||||||<|0.0001|||||||Binomial exact test|||ORR as Assessed by Central Site Imaging Facility||||< 0.0001
72445148|NCT04401800|144405128|SUPERIORITY||||||<|0.0001|||||||Binomial exact test|||ORR as Assessed by the Investigator||||< 0.0001
72445149|NCT04401800|144405128|SUPERIORITY|||||||0.0002|||||||Binomial exact test|||ORR as Assessed by Central Site Imaging Facility||||0.0002
72445150|NCT02651428|144405145|SUPERIORITY||Hazard Ratio (HR)|0.29||||0.0006|TWO_SIDED|95.0|0.14|0.62||The threshold significance level at the interim and final statistical analyses for the primary efficacy endpoint was 0.0294.|Log Rank||The numerator for the hazard ratio was the estimated hazard for the Neutrolin treatment arm, and the denominator was the estimated hazard for the Heparin treatment arm.|The null hypothesis was that there was no difference in the survival functions for CRBSI between the two treatments. Based on 80% power to detect a 55% reduction in the risk of CRBSI relative to the control treatment, a 1:1 randomization, a 2-sided log-rank test, one interim analysis using the method of Pocock, and an overall alpha of 0.05, it was determined that 56 CRBSIs would be needed. These are the results of the final analysis.||0.62|0.14|0.0006
72497526|NCT02939131|144524900|SUPERIORITY||Mean Difference (Final Values)|-0.6||||0.96|TWO_SIDED|95.0|-24.8|23.5|||t-test, 2 sided||A positive difference would indicate higher site-level percentages in the COMB-R group and vice versa.|The site-level percentages of participants ever using any illegal substance excluding marijuana (cannabis) reported at week 48 were computed and compared across treatment groups.||23.5|-24.8|0.96
72497527|NCT02939131|144524901|SUPERIORITY||Mean Difference (Final Values)|10.1||||0.53|TWO_SIDED|95.0|-23.9|44.1|||t-test, 2 sided||A positive difference indicates a higher site-level percentage of participants reporting regular use fof marijuana in the COMB-R group compared to the ESC group.|This is the analysis for regular use of marijuana (cannabis) at week 24. The percent of participants at each site reporting regular use (of those reporting any use) was computed. These site-level percentages were averaged and compared across treatments.||44.1|-23.9|0.53
72497528|NCT02939131|144524901|SUPERIORITY||Mean Difference (Final Values)|-0.1||||1|TWO_SIDED|95.0|-35.1|34.9|||t-test, 2 sided||A positive difference would indicate higher site-level percentages of regular use of marijuana (cannabis) in the COMB-R group compared to the ESC group.|This is the analysis of regular use of marijuana (cannabis) at week 48. Of those reporting ever used, the percent at each site reporting regular use was computed. These site-level percentages were averaged and compared across treatment groups.||34.9|-35.1|1.0
72497529|NCT02939131|144524901|SUPERIORITY||Mean Difference (Final Values)|24.7||||0.18|TWO_SIDED|95.0|-16.2|65.5|||t-test, 2 sided||A positive difference would indicate higher site-level percentages of regular substance use in the COMB-R group compared to the ESC group.|This is the analysis of regular use of any illegal substance, excluding cannabis, at week 24. Of those reporting ever used, the percent at each site reporting regular use was computed. These site-level percentages were averaged and compared across treatment groups.||65.5|-16.2|0.18
72445151|NCT02651428|144405146|SUPERIORITY||Hazard Ratio (HR)|1.08||||0.4161|TWO_SIDED|95.0|0.9|1.29||The threshold for statistical significance was p \< 0.05.|Log Rank||The numerator for the hazard ratio was the estimated hazard for the Neutrolin treatment arm, and the denominator was the estimated hazard for the Heparin treatment arm.|The null hypothesis was that there was no difference in the time until catheter removal for any reason between the two treatments.||1.29|0.90|0.4161
72445152|NCT03843151|144405221|OTHER||Ratio|192.67|||||TWO_SIDED|90.0|175.19|211.89|||||"The effect of itraconazole on BI 1358894 is estimated by the ratio of geometric mean (BI 1358894 + itraconazole / BI 1358894).~geometric coefficient of variation (gCV) \[%\] = 14.9."|The statistical model used for the analysis of the primary endpoints was an analysis of variance (ANOVA) model on the logarithmic scale. That is, the PK endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model. This model included effects accounting for 'subject' and 'treatment'. The 'subject' effect was considered as random, whereas the 'treatment' effect was considered as fixed.||211.89|175.19|
72445153|NCT03843151|144405222|OTHER||Ratio|120.72|||||TWO_SIDED|90.0|105.69|137.87|||||"The effect of itraconazole on BI 1358894 is estimated by the ratio of geometric mean (BI 1358894 + itraconazole / BI 1358894).~geometric coefficient of variation (gCV) \[%\] = 21.7."|The statistical model used for the analysis of the primary endpoints was an analysis of variance (ANOVA) model on the logarithmic scale. That is, the PK endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model. This model included effects accounting for 'subject' and 'treatment'. The 'subject' effect was considered as random, whereas the 'treatment' effect was considered as fixed.||137.87|105.69|
72445154|NCT03843151|144405223|OTHER||Ratio|120.72|||||TWO_SIDED|90.0|105.69|137.87|||||"The effect of itraconazole on BI 1358894 is estimated by the ratio of geometric mean (BI 1358894 + itraconazole / BI 1358894).~geometric coefficient of variation (gCV) \[%\] = 13.3."|The statistical model used for the analysis of the primary endpoints was an analysis of variance (ANOVA) model on the logarithmic scale. That is, the PK endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model. This model included effects accounting for 'subject' and 'treatment'. The 'subject' effect was considered as random, whereas the 'treatment' effect was considered as fixed.||137.87|105.69|
72560678|NCT00830167|144651705|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.33|STANDARD_ERROR_OF_MEAN|1.52||0.0144|TWO_SIDED|95.0|-6.31|-0.35||The analysis was conducted using 1-sided test with the significance level of 0.025.|ANCOVA|||The null hypothesis was to assume that there was no difference between the pregabalin and placebo groups. The alternative was that the pregabalin group was superior to the placebo group.||-0.35|-6.31|0.0144
72389551|NCT00668707|144287001|SUPERIORITY||Mean Difference (Net)|1.2||||0.36|TWO_SIDED|95.0|-1.3|3.7|||Mixed Models Analysis|Between-arm least squares mean difference in change from randomization to 24 months post-surgery represented the effect of the intervention.||Analysis for the LC-13 scale.||3.7|-1.3|0.36
72389552|NCT00668707|144287001|SUPERIORITY||Mean Difference (Net)|0.4||||0.8|TWO_SIDED|95.0|-2.5|3.3||Between-arm least squares mean difference in change from randomization to 24 months post-surgery represented the effect of the intervention.|Mixed Models Analysis|||Analysis for Symptom Scale.||3.3|-2.5|0.80
72389553|NCT00668707|144287001|SUPERIORITY||Mean Difference (Net)|-0.7||||0.69|TWO_SIDED|95.0|-4.1|2.7||Between-arm least squares mean difference in change from randomization to 24 months post-surgery represented the effect of the intervention.|Mixed Models Analysis|||Analysis for Functional Scale.||2.7|-4.1|0.69
72389554|NCT00668707|144287001|SUPERIORITY||Mean Difference (Net)|-3.8||||0.11|TWO_SIDED|95.0|-8.5|0.9||Between-arm least squares mean difference in change from randomization to 24 months post-surgery represented the effect of the intervention.|Mixed Models Analysis|||Analysis for Global Scale.||0.9|-8.5|0.11
72389555|NCT00668707|144287002|SUPERIORITY||Mean Difference (Net)|-3.1||||0.13|TWO_SIDED|95.0|-7.2|0.9|||Mixed Models Analysis|||Between-arm least squares mean difference in change from randomization to 24 months post-surgery represented the effect of the intervention.||0.9|-7.2|0.13
72389556|NCT00668707|144287003|SUPERIORITY||Mean Difference (Net)|-4.1||||0.18|TWO_SIDED|95.0|-10.0|1.9|||Mixed Models Analysis|Between-arm least squares mean difference in change from randomization to 24 months post-surgery represented the effect of the intervention.||Sleep Adequacy Analysis.||1.9|-10.0|0.18
72389557|NCT00668707|144287003|SUPERIORITY||Mean Difference (Net)|1.4||||0.41|TWO_SIDED|95.0|-2.0|4.8|||Mixed Models Analysis|Between-arm least squares mean difference in change from randomization to 24 months post-surgery represented the effect of the intervention.||Sleep problems index II analysis.||4.8|-2.0|0.41
72389558|NCT00668707|144287007|SUPERIORITY|||||||0.62|||||||Chi-squared|||||||0.62
72389559|NCT00668707|144287008|SUPERIORITY||Hazard Ratio (HR)|0.95||||0.41|TWO_SIDED|95.0|0.85|1.07|||Log Rank|||DFS up to five years post-surgery was compared using Kaplan-Meier curves and the log rank test, followed by a hazard ratio calculated using the Cox proportional hazard model adjusting for adjuvant chemotherapy, adjuvant radiation, and smoking history.||1.07|0.85|0.41
72389560|NCT00668707|144287008|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.66|TWO_SIDED|95.0|0.85|1.11|||Log Rank|||This analysis included only those with stage I or II cancer (pathologic stage). DFS up to five years post-surgery was compared using Kaplan-Meier curves and the log rank test, followed by a hazard ratio calculated using the Cox proportional hazard model adjusting for adjuvant chemotherapy, adjuvant radiation, and smoking history.||1.11|0.85|0.66
72389561|NCT00668707|144287008|SUPERIORITY||Hazard Ratio (HR)|0.75||||0.004|TWO_SIDED|95.0|0.61|0.92|||Log Rank|||This analysis included only those participants who had stage III or IV cancer (pathologic stage). DFS up to five years post-surgery was compared using Kaplan-Meier curves and the log rank test, followed by a hazard ratio calculated using the Cox proportional hazard model adjusting for adjuvant chemotherapy, adjuvant radiation, and smoking history.||0.92|0.61|0.004
72389562|NCT00668707|144287009|SUPERIORITY||Mean Difference (Final Values)|-0.67||||0.95|TWO_SIDED|95.0|-3.21|4.56|||Wilcoxon (Mann-Whitney)|||Analysis of melatonin changes||4.56|-3.21|0.95
72389563|NCT00668707|144287009|SUPERIORITY||Mean Difference (Final Values)|3.63||||0.02|TWO_SIDED|95.0|-0.15|7.42|||Wilcoxon (Mann-Whitney)|||Analysis of placebo changes||7.42|-0.15|0.02
72389564|NCT00668707|144287010|SUPERIORITY|||||||0.37|||||||Chi-squared|||||||0.37
72389565|NCT00668707|144287011|SUPERIORITY|||||||0.34|||||||Wilcoxon (Mann-Whitney)|||This analysis compares the mean ratios of 6 month cytotoxicity and baseline cytotoxicity between arms.||||0.34
72389566|NCT03137537|144287027|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
72389567|NCT03137537|144287028|SUPERIORITY|||||||0.63|||||||Wilcoxon (Mann-Whitney)|||||||0.63
72389568|NCT03386448|144287042|SUPERIORITY|Student test was performed|Mean Difference (Final Values)|9.0||||0.03|TWO_SIDED||||||t-test, 2 sided|||||||0.03
72389569|NCT01211730|144287043|SUPERIORITY_OR_OTHER|||||||0.709|||||||Chi-squared, Corrected|||||||0.709
72389570|NCT01211730|144287044|SUPERIORITY_OR_OTHER|||||||0.003|||||||Chi-squared, Corrected|||||||0.003
72389571|NCT01211730|144287045|SUPERIORITY_OR_OTHER|||||||0.0046|||||||Chi-squared, Corrected|||||||0.0046
72389572|NCT01211730|144287046|SUPERIORITY_OR_OTHER|||||||0.75|||||||Chi-squared, Corrected|||||||0.75
72389573|NCT01211730|144287047|SUPERIORITY_OR_OTHER|||||||0.56|||||||Chi-squared, Corrected|||||||0.56
72389574|NCT01211730|144287048|SUPERIORITY_OR_OTHER|||||||0.77|||||||Chi-squared, Corrected|||||||0.77
72389575|NCT03338010|144287049|NON_INFERIORITY|0.40% noninferiority margin was used.|LS Mean Difference|-0.05||||0.545|TWO_SIDED|95.0|-0.19|0.1|||Mixed Models Analysis|||||0.10|-0.19|0.545
72389576|NCT03338010|144287050|NON_INFERIORITY|0.40% noninferiority margin was used.|LS Mean Difference|-0.05||||0.545|TWO_SIDED|95.0|-0.19|0.1|||Mixed Models Analysis|||||0.10|-0.19|0.545
72389577|NCT03338010|144287051|SUPERIORITY||LS Mean Difference|1.0||||0.602|TWO_SIDED|95.0|-2.8|4.8|||Mixed Models Analysis|||Before Morning Meal Glucose||4.8|-2.8|0.602
72389578|NCT03338010|144287051|SUPERIORITY||LS Mean Difference|-3.7||||0.373|TWO_SIDED|95.0|-11.8|4.4|||Mixed Models Analysis|||2 Hours After Morning Meal Glucose||4.4|-11.8|0.373
72389579|NCT03338010|144287051|SUPERIORITY||LS Mean Difference|-3.3||||0.351|TWO_SIDED|95.0|-10.3|3.7|||Mixed Models Analysis|||Before Mid-Day Meal Glucose||3.7|-10.3|0.351
72389580|NCT03338010|144287051|SUPERIORITY||LS Mean Difference|4.9||||0.23|TWO_SIDED|95.0|-3.1|12.8|||Mixed Models Analysis|||2 Hours After Mid-Day Meal Glucose||12.8|-3.1|0.230
72445155|NCT03001414|144405224|SUPERIORITY||Mean Difference (Final Values)|13.7|STANDARD_ERROR_OF_MEAN|16.69||0.42|TWO_SIDED|95.0|-20.08|47.48|||ANOVA|Global test of difference between the arms analyzed as absolute change from baseline.||Due to sample size restriction, the primary analysis plan was modified to analyze change from baseline to each time point using repeated measures of ANOVA.||47.48|-20.08|0.42
72445156|NCT03001414|144405224|SUPERIORITY||Mean Difference (Final Values)|13.7||||0.57|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Calculation of raw change from baseline in meters using non-parametric Wilcoxon test.||||0.57
72445157|NCT03001414|144405224|SUPERIORITY||Mean Difference (Final Values)|4.55||||0.53|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|Secondary analysis of primary outcome using non-parametric Wilcoxon test of percent change from baseline.||||||0.53
72445158|NCT03001414|144405225|SUPERIORITY|Change from baseline calculated in meters using non-parametric analysis.|Mean Difference (Final Values)|41.97||||0.1|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Comparison of these arms is in accordance with the statistical analysis plan.||||0.10
72445159|NCT03001414|144405226|SUPERIORITY||Mean Difference (Final Values)|5.6||||0.5|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||The selected arm for this outcome measure is in accordance with the statistical analysis plan.||||0.50
72445160|NCT03001414|144405227|SUPERIORITY||Mean Difference (Final Values)|22.92||||0.88|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|Comparison of change from baseline in meters at 6 and 12 months.||Selection of the arm for analysis of this outcome measure is in accordance with the statistical analysis plan.||||0.88
72445161|NCT03001414|144405228|SUPERIORITY||Mean Difference (Final Values)|0.132||||0.81|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Selection of the arms for analysis of this outcome measure is in accordance with the statistical analysis plan.||||0.81
72445162|NCT03001414|144405229|SUPERIORITY||Median Difference (Final Values)|2.06||||0.63|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Selection of the arms for analysis of this outcome measure is in accordance with the statistical analysis plan.||||0.63
72445163|NCT03001414|144405230|SUPERIORITY||Mean Difference (Final Values)|1.39||||0.25|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.25
72445164|NCT03001414|144405231|SUPERIORITY||Mean Difference (Final Values)|5.6||||1|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|This analysis represents the results for the Physical Component score of the questionnaire.||Selection of the arms for analysis of this outcome measure is in accordance with the statistical analysis plan.||||1.0
72445165|NCT03001414|144405231|SUPERIORITY||Median Difference (Final Values)|0.1||||0.64|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||This analysis represents the difference in score for the mental component of the questionnaire.|Selection of the arms for analysis of this outcome measure is in accordance with the statistical analysis plan.||||0.64
72445166|NCT03001414|144405232|SUPERIORITY||Mean Difference (Final Values)|8.0||||0.4|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||This analysis represents the difference in score for the physical component of the questionnaire.|Selection of the arms for analysis of this outcome measure is in accordance with the statistical analysis plan.||||0.40
72445167|NCT03001414|144405232|SUPERIORITY||Mean Difference (Final Values)|15.4||||0.23|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||||This analysis represents the change in score for the mental component of the questionnaire.|||0.23
72497530|NCT02939131|144524901|SUPERIORITY||Mean Difference (Final Values)|-18.3||||0.34|TWO_SIDED|95.0|-59.5|22.9|||t-test, 2 sided||A positive difference would indicate higher site-level percentages of regular substance use in the COMB-R group compared to the ESC group.|This is the analysis of regular use of any illegal substance, excluding cannabis, at week 48. Of those reporting ever used, the percent at each site reporting regular use was computed. These site-level percentages were averaged and compared across treatment groups.||22.9|-59.5|0.34
72445168|NCT04831216|144405236|OTHER|||||||0.0107||||||The p-value reflects results of analysis of change in HbA1c from baseline to post-intervention.|Mixed Models Analysis|Linear mixed effects regression model included time, age, household size, gender, race, education, and employment.||Linear mixed effects regression model for repeated measures used all available participant data. Analyses do not include imputed missing values.||||0.0107
72445169|NCT04831216|144405237|OTHER|||||||0.7927||||||The p-value reflects results of analysis of change in skin carotenoid levels from baseline to post-intervention.|Mixed Models Analysis|Linear mixed effects regression model included time, age, household size, gender, race, education, and employment.||Linear mixed effects regression model for repeated measures used all available participant data. Analyses do not include imputed missing values.||||0.7927
72560679|NCT00830167|144651706|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.28|STANDARD_ERROR_OF_MEAN|0.16||0.0376|TWO_SIDED|95.0|-0.59|0.03||The analysis was conducted using 1-sided test with the significance level of 0.025.|ANCOVA|||The null hypothesis was to assume that there was no difference between the pregabalin and placebo groups. The alternative was that the pregabalin group was superior to the placebo group.||0.03|-0.59|0.0376
72445170|NCT04831216|144405238|OTHER|||||||0.4651||||||The p-value reflects results of analysis of change in HEI score from baseline to post-intervention.|Mixed Models Analysis|Linear mixed effects regression model included time, age, household size, gender, race, education, and employment.||Linear mixed effects regression model for repeated measures used all available participant data. Analyses do not include imputed missing values.||||0.4651
72445171|NCT04831216|144405239|OTHER|||||||0.2439||||||The p-value reflects results of analysis of change in BMI from baseline to post-intervention.|Mixed Models Analysis|Linear mixed effects regression model included time, age, household size, gender, race, education, and employment.||Linear mixed effects regression model for repeated measures used all available participant data. Analyses do not include imputed missing values.||||0.2439
72445172|NCT04831216|144405241|OTHER|||||||0.6794||||||The p-value reflects results of analysis of change in DMSES scale score from baseline to post-intervention.|Mixed Models Analysis|Linear mixed effects regression model included time, age, household size, gender, race, education, and employment.||Linear mixed effects regression model for repeated measures used all available participant data. Analyses do not include imputed missing values.||||0.6794
72445173|NCT04831216|144405242|OTHER|||||||0.1043||||||The p-value reflects results of analysis of change in oral health behavior from baseline to post-intervention.|Mixed Models Analysis|Cumulative logit mixed effects model included time, age, household size, gender, race, education, and employment.||Cumulative logit mixed effects model (using PROC GLIMMIX) for repeated measures used all available participant data. This model is specifically designed for ordinal outcomes. Analyses do not include imputed missing values.||||0.1043
72389581|NCT03338010|144287051|SUPERIORITY||LS Mean Difference|0.9||||0.819|TWO_SIDED|95.0|-6.7|8.5|||Mixed Models Analysis|||Before Evening Meal Glucose||8.5|-6.7|0.819
72389582|NCT03338010|144287051|SUPERIORITY||LS Mean Difference|2.3||||0.588|TWO_SIDED|95.0|-6.2|10.9|||Mixed Models Analysis|||2 Hours After Evening Meal Glucose||10.9|-6.2|0.588
72389583|NCT03338010|144287051|SUPERIORITY||LS Mean Difference|1.4||||0.732|TWO_SIDED|95.0|-6.7|9.5|||Mixed Models Analysis|||Bedtime Glucose||9.5|-6.7|0.732
72389584|NCT03338010|144287052|SUPERIORITY|||||||0.846|||||||Fisher Exact|||||||0.846
72389585|NCT03338010|144287053|SUPERIORITY|||||||0.098|||||||Fisher Exact|||||||0.098
72389586|NCT03338010|144287054|SUPERIORITY||LS Mean Difference|0.32||||0.767|TWO_SIDED|95.0|-1.78|2.42|||Mixed Models Analysis|||Morning Pre-meal Standard Deviation||2.42|-1.78|0.767
72389587|NCT03338010|144287054|SUPERIORITY||LS Mean Difference|0.4||||0.781|TWO_SIDED|95.0|-2.5|3.3|||Mixed Models Analysis|||Daily Mean Standard Deviation||3.3|-2.5|0.781
72389588|NCT03338010|144287055|SUPERIORITY||LS Mean Difference|0.2||||0.75|TWO_SIDED|95.0|-1.2|1.7|||Mixed Models Analysis|||||1.7|-1.2|0.750
72389589|NCT03338010|144287056|SUPERIORITY||LS Mean Difference|0.2||||0.75|TWO_SIDED|95.0|-1.2|1.7|||Mixed Models Analysis|||||1.7|-1.2|0.750
72389590|NCT03338010|144287057|SUPERIORITY||LS Mean Difference|-0.1|||<|0.001|TWO_SIDED|95.0|-0.6|0.3|||Mixed Models Analysis|||||0.3|-0.6|<0.001
72389591|NCT03338010|144287058|SUPERIORITY||LS Mean Difference|-0.95||||0.5|TWO_SIDED|95.0|-3.72|1.82|||Mixed Models Analysis|||Inconvenience of Regimen Transformed Score||1.82|-3.72|0.500
72389592|NCT03338010|144287058|SUPERIORITY||LS Mean Difference|-3.99||||0.031|TWO_SIDED|95.0|-7.62|-0.36|||Mixed Models Analysis|||Lifestyle Flexibility Transformed Score||-0.36|-7.62|0.031
72389593|NCT03338010|144287058|SUPERIORITY||LS Mean Difference|-1.79||||0.2|TWO_SIDED|95.0|-4.53|0.95|||Mixed Models Analysis|||Hypoglycemic Control Transformed Score||0.95|-4.53|0.200
72389594|NCT03338010|144287058|SUPERIORITY||LS Mean Difference|-0.02||||0.988|TWO_SIDED|95.0|-2.92|2.88|||Mixed Models Analysis|||Glycemic Control Transformed Score||2.88|-2.92|0.988
72389595|NCT03338010|144287058|SUPERIORITY||LS Mean Difference|-1.45||||0.337|TWO_SIDED|95.0|-4.41|1.51|||Mixed Models Analysis|||Insulin Delivery Device Satisfaction Transformed Score||1.51|-4.41|0.337
72389596|NCT03338010|144287058|SUPERIORITY||LS Mean Difference|-1.67||||0.205|TWO_SIDED|95.0|-4.26|0.92|||Mixed Models Analysis|||ITSQ Overall Total||0.92|-4.26|0.205
72389597|NCT03338010|144287059|SUPERIORITY|||||||0.639|||||||Fisher Exact|||||||0.639
72389598|NCT03338010|144287060|SUPERIORITY||Relative Ratio|1.19||||0.143|TWO_SIDED|95.0|0.74|1.92|||Wilcoxon (Mann-Whitney)|||||1.92|0.74|0.143
72389599|NCT03338010|144287060|SUPERIORITY||Relative Ratio|1.22||||0.945|TWO_SIDED|95.0|0.67|2.23|||Wilcoxon (Mann-Whitney)|||||2.23|0.67|0.945
72389600|NCT02465515|144287072|NON_INFERIORITY|Non-inferiority was determined by testing the hypothesis that the observed hazard ratio is significantly different from the null margin of 1.3 (a one-sided p \<0.025 for such a test with result in appropriate direction being equivalent to the upper 95% confidence limit for the hazard ratio being less than 1.3)|Hazard Ratio (HR)|0.78|||<|0.0001|TWO_SIDED|95.0|0.68|0.9||One-sided p-value based on Wald test of hazard ratio (HR) \>=1.3 versus HR \<1.3.|Wald test||Hazard ratio is estimated using a Cox proportional hazard regression model with treatment as the only covariate|||0.90|0.68|<0.0001
72389601|NCT02465515|144287072|SUPERIORITY||||||<|0.001||||||Two-sided p-value based on Wald test of HR=1 versus HR not equal to 1|Wald test|||||||<0.001
72389602|NCT02465515|144287073|OTHER||Hazard Ratio (HR)|0.78|||<|0.001|TWO_SIDED|95.0|0.69|0.9||Two-sided p-value based on the Wald statistic.|Wald statistic||Hazard ratio is estimated using a Cox proportional hazard regression model with treatment as the only covariate.|||0.90|0.69|<0.001
72389603|NCT02465515|144287074|OTHER||Hazard Ratio (HR)|0.93||||0.578|TWO_SIDED|95.0|0.73|1.19||Two-sided p-value based on the Wald statistic|Wald statistic||Hazard ratio is estimated using a Cox proportional hazard regression model with treatment as the only covariate|||1.19|0.73|0.578
72389604|NCT02465515|144287075|OTHER||Hazard Ratio (HR)|0.75||||0.003|TWO_SIDED|95.0|0.61|0.9||Two-sided p-value based on the Wald statistic.|Wald statistic||Hazard ratio is estimated using a Cox proportional hazard regression model with treatment as the only covariate.|||0.90|0.61|0.003
72389605|NCT02465515|144287076|OTHER||Hazard Ratio (HR)|0.86||||0.3|TWO_SIDED|95.0|0.66|1.14||Two-sided p-value based on the Wald statistic.|Wald statistic||Hazard ratio is estimated using a Cox proportional hazard regression model with treatment as the only covariate.|||1.14|0.66|0.300
72389606|NCT02465515|144287077|OTHER||Hazard Ratio (HR)|0.85||||0.113|TWO_SIDED|95.0|0.7|1.04||Two-sided p-value based on the Wald statistic.|Wald statistic||Hazard ratio is estimated using a Cox proportional hazard regression model with treatment as the only covariate.|||1.04|0.70|0.113
72389607|NCT02465515|144287078|SUPERIORITY||Hazard Ratio (HR)|0.42|||<|0.001|TWO_SIDED|95.0|0.33|0.53||Two-sided p-value based on Wald test of HR=1 versus HR not equal to 1.|Wald test||Hazard ratio is estimated using a Cox proportional hazard regression model with treatment as the only covariate.|||0.53|0.33|<0.001
72389608|NCT02465515|144287079|SUPERIORITY||Hazard Ratio (HR)|0.71||||0.043|TWO_SIDED|95.0|0.51|0.99||Two-sided p-value based on Wald test of HR=1 versus HR not equal to 1.|Wald test||Hazard ratio is estimated using a Cox proportional hazard regression model with treatment as the only covariate.|||0.99|0.51|0.043
72389609|NCT02465515|144287080|OTHER||||||<|0.001||||||P-value based on the covariate-adjusted extended Mantel-Haenszel test. Covariates include Baseline HbA1c (\<8.0% versus \>= 8.0%) and Baseline diabetes therapy (diet and exercise alone versus all other therapies).|Mantel Haenszel|Month 8||||||<0.001
72389610|NCT02465515|144287080|OTHER||||||<|0.001||||||P-value based on the covariate-adjusted extended Mantel-Haenszel test. Covariates include Baseline HbA1c (\<8.0% versus \>= 8.0%) and Baseline diabetes therapy (diet and exercise alone versus all other therapies).|Mantel Haenszel|Month 16||||||<0.001
72389611|NCT02465515|144287080|OTHER||||||<|0.001||||||P-value based on the covariate-adjusted extended Mantel-Haenszel test. Covariates include Baseline HbA1c (\<8.0% versus \>= 8.0%) and Baseline diabetes therapy (diet and exercise alone versus all other therapies).|Mantel Haenszel|Month 24||||||<0.001
72389612|NCT02465515|144287080|OTHER||||||<|0.001||||||P-value based on the covariate-adjusted extended Mantel-Haenszel test. Covariates include Baseline HbA1c (\<8.0% versus \>= 8.0%) and Baseline diabetes therapy (diet and exercise alone versus all other therapies).|Mantel Haenszel|Final assessment||||||<0.001
72445174|NCT04831216|144405243|OTHER||||||<|0.0001||||||The p-value reflects results of analysis of change in PAID-5 scale score from baseline to post-intervention.|Mixed Models Analysis|Linear mixed effects regression model included time, age, household size, gender, race, education, and employment.||Linear mixed effects regression model for repeated measures used all available participant data. Analyses do not include imputed missing values.||||<0.0001
72445175|NCT04831216|144405245|OTHER|||||||0.5332||||||The p-value reflects results of analysis of change in number of visits to food pantries in the past 30 days from baseline to post-intervention.|Mixed Models Analysis|Linear mixed effects regression model included time, age, household size, gender, race, education, and employment.||Linear mixed effects regression model for repeated measures used all available participant data. Analyses do not include imputed missing values.||||0.5332
72445176|NCT04831216|144405246|OTHER|||||||0.0468||||||The p-value reflects results of analysis of change in ARMS-D scale scores from baseline to post-intervention.|Mixed Models Analysis|Linear mixed effects regression model included time, age, household size, gender, race, education, and employment.||Linear mixed effects regression model for repeated measures used all available participant data. Analyses do not include imputed missing values.||||0.0468
72445177|NCT04831216|144405249|OTHER||||||<|0.0001||||||The p-value reflects results of analysis of change in days per week following general healthful diet from baseline to post-intervention.|Mixed Models Analysis|Linear mixed effects regression model included time, age, household size, gender, race, education, and employment.||Linear mixed effects regression model for repeated measures used all available participant data. Analyses do not include imputed missing values.||||<0.0001
72445178|NCT04831216|144405250|OTHER|||||||0.0649||||||The p-value reflects results of analysis of change in days per week following specific diet recommendations from baseline to post-intervention.|Mixed Models Analysis|Linear mixed effects regression model included time, age, household size, gender, race, education, and employment.||Linear mixed effects regression model for repeated measures used all available participant data. Analyses do not include imputed missing values.||||0.0649
72445179|NCT04831216|144405251|OTHER|||||||0.0049||||||The p-value reflects results of analysis of change in days per week engaging in exercise from baseline to post-intervention.|Mixed Models Analysis|Linear mixed effects regression model included time, age, household size, gender, race, education, and employment.||Linear mixed effects regression model for repeated measures used all available participant data. Analyses do not include imputed missing values.||||0.0049
72445180|NCT04831216|144405252|OTHER|||||||0.0086||||||The p-value reflects results of analysis of change in days per week conducted blood glucose testing from baseline to post-intervention.|Mixed Models Analysis|Linear mixed effects regression model included time, age, household size, gender, race, education, and employment.||Linear mixed effects regression model for repeated measures used all available participant data. Analyses do not include imputed missing values.||||0.0086
72445181|NCT04831216|144405253|OTHER|||||||0.0243||||||The p-value reflects results of analysis of change in days per week conducting food checks from baseline to post-intervention.|Mixed Models Analysis|Linear mixed effects regression model included time, age, household size, gender, race, education, and employment.||Linear mixed effects regression model for repeated measures used all available participant data. Analyses do not include imputed missing values.||||0.0243
72445182|NCT04831216|144405254|OTHER|||||||0.2861||||||The p-value reflects results of analysis of change in smoking status (yes/no) from baseline to post-intervention.|Mixed Models Analysis|Linear mixed effects regression model included time, age, household size, gender, race, education, and employment.||Linear mixed effects regression model for repeated measures used all available participant data. Analyses do not include imputed missing values.||||0.2861
72445183|NCT04831216|144405255|OTHER|||||||0.9933||||||The p-value reflects results of analysis of change in days per week adhering to prescribed medications from baseline to post-intervention.|Mixed Models Analysis|Linear mixed effects regression model included time, age, household size, gender, race, education, and employment.||Linear mixed effects regression model for repeated measures used all available participant data. Analyses do not include imputed missing values.||||0.9933
72445184|NCT03930342|144405276|SUPERIORITY||Risk Ratio (RR)|0.94|||||TWO_SIDED|95.0|0.83|1.07|||Regression, Logistic|Used marginal standardization to estimate relative risk from logistic regression||Results here reflect analysis of the relative risk for AEP that is a combination of risk from baseline to the 3 month timepoint and risk between the 3 month timepoint and 6 month timepoint. This reflects changes in AEP risk across the course of exposure to the intervention (baseline to 3 month) and enduring change post-exposure (3 months to 6 months)||1.07|0.83|
72445185|NCT01804816|144405370|EQUIVALENCE|a=0.05||||||0.063|||||||t-test, 2 sided|||||||0.063
72445186|NCT01804816|144405371|EQUIVALENCE|a = 0.05||||||0.005|||||||t-test, 2 sided|||Based on results from prior small clinical trials we estimate the need for 20 patients enrolled to reach 80% statistical power.||||0.005
72445187|NCT01804816|144405371|EQUIVALENCE|a=0.05||||||0.002|||||||t-test, 2 sided|||||||0.002
72445188|NCT01804816|144405371|EQUIVALENCE|a=0.05||||||0.441|||||||t-test, 2 sided|||||||0.441
72445189|NCT01804816|144405372|EQUIVALENCE|a=0.05||||||0.729|||||||t-test, 2 sided|||||||0.729
72445190|NCT03400059|144405374|SUPERIORITY||Mean Difference (Final Values)|-2.23||||0.0132|TWO_SIDED|95.0|-4.11|-0.49||"analysis of covariance (ANCOVA) model containing terms for treatment, baseline value and medication overuse.~Group-sequential analysis using updated boundaries from interim analysis"|ANCOVA|||||-0.49|-4.11|0.0132
72445191|NCT03400059|144405375|SUPERIORITY||Mean Difference (Final Values)|-2.68||||0.0014|TWO_SIDED|95.0|-4.32|-1.04|||ANCOVA|ANCOVA model containing terms for treatment, baseline value and medication overuse||||-1.04|-4.32|0.0014
72445192|NCT03400059|144405376|SUPERIORITY||Mean Difference (Final Values)|-2.4||||0.0048|TWO_SIDED|95.0|-4.06|-0.73|||ANCOVA|ANCOVA model containing terms for treatment, baseline value and medication overuse||||-0.73|-4.06|0.0048
72445193|NCT03400059|144405377|SUPERIORITY||Mean Difference (Final Values)|-2.87||||0.0008|TWO_SIDED|95.0|-4.54|-1.2|||ANCOVA|ANCOVA model containing terms for treatment, baseline value and medication overuse.||||-1.20|-4.54|0.0008
72445194|NCT03400059|144405378|SUPERIORITY||Mean Difference (Final Values)|-1.53||||0.0598|TWO_SIDED|95.0|-3.12|0.06|||ANCOVA|ANCOVA model containing terms for treatment, baseline value and medication overuse.||||0.06|-3.12|0.0598
72445195|NCT03400059|144405379|SUPERIORITY||Mean Difference (Final Values)|-1.9||||0.031|TWO_SIDED|95.0|-3.63|-0.17|||ANCOVA|ANCOVA model containing terms for treatment, baseline value and medication overuse.||||-0.17|-3.63|0.0310
72445196|NCT03400059|144405380|SUPERIORITY|||||||0.0102|||||||Chi-squared|||||||0.0102
72445197|NCT03400059|144405381|SUPERIORITY|||||||0.1615|||||||Chi-squared|||||||0.1615
72560680|NCT00830167|144651707|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.63|STANDARD_ERROR_OF_MEAN|0.25||0.0052|TWO_SIDED|95.0|-1.12|-0.15||The analysis was conducted using 1-sided test with the significance level of 0.025.|ANCOVA|||The null hypothesis was to assume that there was no difference between the pregabalin and placebo groups. The alternative was that the pregabalin group was superior to the placebo group.||-0.15|-1.12|0.0052
72560681|NCT00830167|144651708|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.21||0.4768|TWO_SIDED|95.0|-0.42|0.4||The analysis was conducted using 1-sided test with the significance level of 0.025.|ANCOVA|||The null hypothesis was to assume that there was no difference between the pregabalin and placebo groups. The alternative was that the pregabalin group was superior to the placebo group.||0.40|-0.42|0.4768
72560682|NCT00830167|144651709|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.31|STANDARD_ERROR_OF_MEAN|0.21||0.0729|TWO_SIDED|95.0|-0.74|0.11||The analysis was conducted using 1-sided test with the significance level of 0.025.|ANCOVA|||The null hypothesis was to assume that there was no difference between the pregabalin and placebo groups. The alternative was that the pregabalin group was superior to the placebo group.||0.11|-0.74|0.0729
72560683|NCT00830167|144651710|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.41|STANDARD_ERROR_OF_MEAN|0.21||0.0238|TWO_SIDED|95.0|-0.81|0.0||The analysis was conducted using 1-sided test with the significance level of 0.025.|ANCOVA|||The null hypothesis was to assume that there was no difference between the pregabalin and placebo groups. The alternative was that the pregabalin group was superior to the placebo group.||0.00|-0.81|0.0238
72560684|NCT00830167|144651711|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.49|STANDARD_ERROR_OF_MEAN|0.2||0.0075|TWO_SIDED|95.0|-0.89|-0.1||The analysis was conducted using 1-sided test with the significance level of 0.025.|ANCOVA|||The null hypothesis was to assume that there was no difference between the pregabalin and placebo groups. The alternative was that the pregabalin group was superior to the placebo group.||-0.10|-0.89|0.0075
72619273|NCT01654250|144769240|SUPERIORITY_OR_OTHER||LS Mean Difference|-12.8|STANDARD_ERROR_OF_MEAN|2.28|<|0.001|TWO_SIDED|95.0|-17.3|-8.3|||Mixed Models Analysis|||Hour 2 post-dose: Nominal p value-treatment comparisons for observed scores were assessed using a mixed model repeated measures analysis, with treatment (NWP09/Placebo), study center, time point and time point by treatment interaction as main effects and participant intercept as a random effect.||-8.3|-17.3|<0.001
72445198|NCT03400059|144405382|SUPERIORITY|||||||0.0798|||||||Chi-squared|||||||0.0798
72445199|NCT03400059|144405383|SUPERIORITY|||||||0.13|||||||Chi-squared|||||||0.1300
72445200|NCT03400059|144405384|SUPERIORITY||Median Difference (Final Values)|-1.0||||0.066|TWO_SIDED|||||posthoc|Van-Elteren|||||||0.0660
72445201|NCT03400059|144405385|SUPERIORITY||Median Difference (Final Values)|-2.0||||0.0152|TWO_SIDED|||||posthoc|Van-Elteren|||||||0.0152
72445202|NCT05034952|144405432|SUPERIORITY|||||||0.3914|||||||ANCOVA|||||||0.3914
72445203|NCT05034952|144405432|SUPERIORITY|||||||0.1266|||||||ANCOVA|||||||0.1266
72445204|NCT05034952|144405432|SUPERIORITY|||||||0.0097|||||||ANCOVA|||||||0.0097
72445205|NCT05034952|144405433|SUPERIORITY|||||||0.5476|||||||ANCOVA|||||||0.5476
72445206|NCT05034952|144405433|SUPERIORITY|||||||0.0825|||||||ANCOVA|||||||0.0825
72445207|NCT05034952|144405433|SUPERIORITY|||||||0.0036|||||||ANCOVA|||||||0.0036
72445208|NCT05034952|144405434|SUPERIORITY|||||||0.4712|||||||Cochran-Mantel-Haenszel|||||||0.4712
72445209|NCT05034952|144405434|SUPERIORITY|||||||0.1635|||||||Cochran-Mantel-Haenszel|||||||0.1635
72445210|NCT05034952|144405434|SUPERIORITY|||||||0.1158|||||||Cochran-Mantel-Haenszel|||||||0.1158
72445211|NCT05034952|144405435|SUPERIORITY|||||||0.2882|||||||Cochran-Mantel-Haenszel|||||||0.2882
72445212|NCT05034952|144405435|SUPERIORITY|||||||0.2344|||||||Cochran-Mantel-Haenszel|||||||0.2344
72445213|NCT05034952|144405435|SUPERIORITY|||||||0.1724|||||||Cochran-Mantel-Haenszel|||||||0.1724
72445214|NCT05034952|144405436|SUPERIORITY|||||||0.1343|||||||Cochran-Mantel-Haenszel|||||||0.1343
72445215|NCT05034952|144405436|SUPERIORITY|||||||0.4501|||||||Cochran-Mantel-Haenszel|||||||0.4501
72445216|NCT05034952|144405436|SUPERIORITY|||||||0.1009|||||||Cochran-Mantel-Haenszel|||||||0.1009
72445217|NCT02111798|144405442|SUPERIORITY|||||||0.889|||||||Mixed Models Analysis|||Comparisons were conducted as a function of medication condition, collapsed across abstinence initiation and relapse prevention groups, according to a priori-stated statistical analysis.||||0.889
72445218|NCT02111798|144405443|SUPERIORITY|||||||0.605|||||||Mixed Models Analysis|||Comparisons were conducted as a function of medication condition, collapsed across abstinence initiation and relapse prevention groups, according to a priori-stated statistical analysis.||||0.605
72445219|NCT02437318|144405444|SUPERIORITY||Hazard Ratio (HR)|0.65||||0.00065|TWO_SIDED|95.0|0.5|0.85||(one-sided)|Log Rank|||||0.85|0.50|0.00065
72445220|NCT04321031|144405484|SUPERIORITY||Risk Difference (RD)|0.08|||||TWO_SIDED|90.0|-0.02|0.2|||||Reported values reflect a 90% Credible Interval rather than a 90% Confidence Interval.|The model was applied to the raw number of responders and non-responders utilizing a Bayesian methodology approach with non-informative priors as described in the statistical analysis plan (SAP).||0.20|-0.02|
72445221|NCT04321031|144405484|SUPERIORITY||Risk Difference (RD)|0.1|||||TWO_SIDED|90.0|-0.03|0.24|||||Reported values reflect a 90% Credible Interval rather than a 90% Confidence Interval.|The model was applied to the raw number of responders and non-responders utilizing a Bayesian methodology approach with non-informative priors as described in the SAP.||0.24|-0.03|
72445222|NCT04321031|144405484|SUPERIORITY||Risk Difference (RD)|0.12|||||TWO_SIDED|90.0|-0.03|0.26|||||Reported values reflect a 90% Credible Interval rather than a 90% Confidence Interval.|The model was applied to the raw number of responders and non-responders utilizing a Bayesian methodology approach with non-informative priors as described in the SAP.||0.26|-0.03|
72560685|NCT00830167|144651712|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.59|STANDARD_ERROR_OF_MEAN|0.21||0.0023|TWO_SIDED|95.0|-1.01|-0.18||The analysis was conducted using 1-sided test with the significance level of 0.025.|ANCOVA|||The null hypothesis was to assume that there was no difference between the pregabalin and placebo groups. The alternative was that the pregabalin group was superior to the placebo group.||-0.18|-1.01|0.0023
72619274|NCT01654250|144769240|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Mixed Models Analysis|||Hour 2 post-dose: Adjusted p-values were generated using a fixed sequence testing procedure from p-values which were generated from the mixed effects model.||||<0.001
72445223|NCT04321031|144405484|SUPERIORITY||Risk Difference (RD)|0.13|||||TWO_SIDED|90.0|-0.04|0.28|||||Reported values reflect a 90% Credible Interval rather than a 90% Confidence Interval.|The model was applied to the raw number of responders and non-responders utilizing a Bayesian methodology approach with non-informative priors as described in the SAP.||0.28|-0.04|
72560686|NCT00830167|144651713|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.14|STANDARD_ERROR_OF_MEAN|0.22||0.2568|TWO_SIDED|95.0|-0.57|0.29||The analysis was conducted using 1-sided test with the significance level of 0.025.|ANCOVA|||The null hypothesis was to assume that there was no difference between the pregabalin and placebo groups. The alternative was that the pregabalin group was superior to the placebo group.||0.29|-0.57|0.2568
72560687|NCT00830167|144651714|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.28|STANDARD_ERROR_OF_MEAN|0.22||0.1011|TWO_SIDED|95.0|-0.72|0.15||The analysis was conducted using 1-sided test with the significance level of 0.025.|ANCOVA|||The null hypothesis was to assume that there was no difference between the pregabalin and placebo groups. The alternative was that the pregabalin group was superior to the placebo group.||0.15|-0.72|0.1011
72445224|NCT04321031|144405485|SUPERIORITY||Risk Difference (RD)|0.14|||||TWO_SIDED|90.0|-0.04|0.32||||||Risk difference and 2-sided 90% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.||0.32|-0.04|
72445225|NCT04321031|144405485|SUPERIORITY||Risk Difference (RD)|0.08|||||TWO_SIDED|90.0|-0.11|0.27||||||Risk difference and 2-sided 90% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.||0.27|-0.11|
72445226|NCT04321031|144405485|SUPERIORITY||Risk Difference (RD)|0.12|||||TWO_SIDED|90.0|-0.07|0.3||||||Risk difference and 2-sided 90% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.||0.30|-0.07|
72445227|NCT04321031|144405485|SUPERIORITY||Risk Difference (RD)|0.27|||||TWO_SIDED|90.0|0.07|0.43||||||Risk difference and 2-sided 90% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.||0.43|0.07|
72445228|NCT04321031|144405485|SUPERIORITY||Risk Difference (RD)|0.07|||||TWO_SIDED|90.0|-0.12|0.27||||||Risk difference and 2-sided 90% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.||0.27|-0.12|
72497531|NCT02939131|144524902|SUPERIORITY||Mean Difference (Final Values)|13.4||||0.29|TWO_SIDED|95.0|-12.9|39.6|||t-test, 2 sided||A positive value would indicate higher site-level percents in the COMB-R group.|This is the analysis for week 24. The percentage of participants at a site who reported using sex as a commodity was calculated and the site-level percentages were averaged and compared across treatments.||39.6|-12.9|0.29
72560688|NCT00830167|144651715|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.04|STANDARD_ERROR_OF_MEAN|0.2||0.4165|TWO_SIDED|95.0|-0.44|0.35||The analysis was conducted using 1-sided test with the significance level of 0.025.|ANCOVA|||The null hypothesis was to assume that there was no difference between the pregabalin and placebo groups. The alternative was that the pregabalin group was superior to the placebo group.||0.35|-0.44|0.4165
72445229|NCT04321031|144405485|SUPERIORITY||Risk Difference (RD)|0.25|||||TWO_SIDED|90.0|0.04|0.42||||||Risk difference and 2-sided 90% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.||0.42|0.04|
72445230|NCT04321031|144405485|SUPERIORITY||Risk Difference (RD)|0.16|||||TWO_SIDED|50.0|0.08|0.23||||||Risk difference and 2-sided 50% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.||0.23|0.08|
72445231|NCT04321031|144405485|SUPERIORITY||Risk Difference (RD)|0.16|||||TWO_SIDED|90.0|-0.03|0.31||||||Risk difference and 2-sided 90% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.||0.31|-0.03|
72445232|NCT04321031|144405485|SUPERIORITY||Risk Difference (RD)|0.18|||||TWO_SIDED|50.0|0.09|0.26||||||Risk difference and 2-sided 50% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.||0.26|0.09|
72445233|NCT04321031|144405485|SUPERIORITY||Risk Difference (RD)|0.18|||||TWO_SIDED|90.0|-0.03|0.35||||||Risk difference and 2-sided 90% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.||0.35|-0.03|
72445234|NCT04321031|144405486|SUPERIORITY||Least Square (LS) Mean|-25.98|||||TWO_SIDED|90.0|-58.42|-2.57||||||||-2.57|-58.42|
72445235|NCT04321031|144405486|SUPERIORITY||LS Mean|-35.41|||||TWO_SIDED|90.0|-69.41|-5.42||||||||-5.42|-69.41|
72445236|NCT04321031|144405486|SUPERIORITY||LS Mean|-40.54|||||TWO_SIDED|90.0|-75.55|-7.32||||||||-7.32|-75.55|
72445237|NCT04321031|144405486|SUPERIORITY||LS Mean|-44.74|||||TWO_SIDED|90.0|-81.72|-8.42||||||||-8.42|-81.72|
72445238|NCT04321031|144405487|SUPERIORITY||LS Mean|-41.82|||||TWO_SIDED|90.0|-62.57|-9.57||||||Log-transformed relative changes from baseline are modelled using an ANCOVA model with treatment and baseline fibrosis stage (F2/F3) as factors, and log-transformed baseline liver fat as a covariate.||-9.57|-62.57|
72445239|NCT04321031|144405487|SUPERIORITY||LS Mean|-43.33|||||TWO_SIDED|90.0|-62.37|-14.64||||||Log-transformed relative changes from baseline are modelled using an ANCOVA model with treatment and baseline fibrosis stage (F2/F3) as factors, and log-transformed baseline liver fat as a covariate.||-14.64|-62.37|
72445240|NCT04321031|144405487|SUPERIORITY||LS Mean|-59.35|||||TWO_SIDED|90.0|-73.95|-36.55||||||Log-transformed relative changes from baseline are modelled using an ANCOVA model with treatment and baseline fibrosis stage (F2/F3) as factors, and log-transformed baseline liver fat as a covariate.||-36.55|-73.95|
72445241|NCT04321031|144405487|SUPERIORITY||LS Mean|-68.21|||||TWO_SIDED|90.0|-79.72|-50.15||||||Log-transformed relative changes from baseline are modelled using an ANCOVA model with treatment and baseline fibrosis stage (F2/F3) as factors, and log-transformed baseline liver fat as a covariate.||-50.15|-79.72|
72497532|NCT02939131|144524902|SUPERIORITY||Mean Difference (Final Values)|3.8||||0.7|TWO_SIDED|95.0|-17.0|24.5|||t-test, 2 sided||A positive difference would indicate site-level percentages were higher in the COMB-R group|This is the analysis for week 48. The percentage of participants at a site who reported using sex as a commodity was calculated and the site-level percentages were averaged and compared across treatments.||24.5|-17.0|0.70
72445242|NCT04321031|144405487|SUPERIORITY||LS Mean|-50.46|||||TWO_SIDED|90.0|-69.53|-19.44||||||Log-transformed relative changes from baseline are modelled using an ANCOVA model with treatment and baseline fibrosis stage (F2/F3) as factors, and log-transformed baseline liver fat as a covariate.||-19.44|-69.53|
72445243|NCT04321031|144405487|SUPERIORITY||LS Mean|-69.27|||||TWO_SIDED|90.0|-81.08|-50.07||||||Log-transformed relative changes from baseline are modelled using an ANCOVA model with treatment and baseline fibrosis stage (F2/F3) as factors, and log-transformed baseline liver fat as a covariate.||-50.07|-81.08|
72445244|NCT04321031|144405487|SUPERIORITY||LS Mean|-21.8|||||TWO_SIDED|50.0|-34.02|-7.32||||||Log-transformed relative changes from baseline are modelled using an ANCOVA model with treatment and baseline fibrosis stage (F2/F3) as factors, and log-transformed baseline liver fat as a covariate.||-7.32|-34.02|
72445245|NCT04321031|144405487|SUPERIORITY||LS Mean|-21.8|||||TWO_SIDED|90.0|-48.51|18.76||||||Log-transformed relative changes from baseline are modelled using an ANCOVA model with treatment and baseline fibrosis stage (F2/F3) as factors, and log-transformed baseline liver fat as a covariate.||18.76|-48.51|
72445246|NCT04321031|144405487|SUPERIORITY||LS Mean|-37.97|||||TWO_SIDED|50.0|-49.4|-23.95||||||Log-transformed relative changes from baseline are modelled using an ANCOVA model with treatment and baseline fibrosis stage (F2/F3) as factors, and log-transformed baseline liver fat as a covariate.||-23.95|-49.40|
72445247|NCT04321031|144405487|SUPERIORITY||LS Mean|-37.97|||||TWO_SIDED|90.0|-62.41|2.37||||||Log-transformed relative changes from baseline are modelled using an ANCOVA model with treatment and baseline fibrosis stage (F2/F3) as factors, and log-transformed baseline liver fat as a covariate.||2.37|-62.41|
72445248|NCT04321031|144405488|SUPERIORITY||Risk Difference (RD)|0.21|||||TWO_SIDED|90.0|0.09|0.32|||||Reported values reflect a 90% Credible Interval rather than a 90% Confidence Interval.|The model was applied to the raw number of responders and non-responders utilizing a Bayesian methodology approach with non-informative priors as described in the SAP.||0.32|0.09|
72560689|NCT00830167|144651716|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.29|STANDARD_ERROR_OF_MEAN|1.32||0.0006|TWO_SIDED|95.0|1.7|6.88||The analysis was conducted using 1-sided test with the significance level of 0.025.|ANCOVA|||The null hypothesis was to assume that there was no difference between the pregabalin and placebo groups. The alternative was that the pregabalin group was superior to the placebo group.||6.88|1.70|0.0006
72445249|NCT04321031|144405488|SUPERIORITY||Risk Difference (RD)|0.27|||||TWO_SIDED|90.0|0.15|0.37|||||Reported values reflect a 90% Credible Interval rather than a 90% Confidence Interval.|The model was applied to the raw number of responders and non-responders utilizing a Bayesian methodology approach with non-informative priors as described in the SAP.||0.37|0.15|
72445250|NCT04321031|144405488|SUPERIORITY||Risk Difference (RD)|0.29|||||TWO_SIDED|90.0|0.18|0.39|||||Reported values reflect a 90% Credible Interval rather than a 90% Confidence Interval.|The model was applied to the raw number of responders and non-responders utilizing a Bayesian methodology approach with non-informative priors as described in the SAP.||0.39|0.18|
72445251|NCT04321031|144405488|SUPERIORITY||Risk Difference (RD)|0.31|||||TWO_SIDED|90.0|0.19|0.42|||||Reported values reflect a 90% Credible Interval rather than a 90% Confidence Interval.|The model was applied to the raw number of responders and non-responders utilizing a Bayesian methodology approach with non-informative priors as described in the SAP.||0.42|0.19|
72445252|NCT04321031|144405489|SUPERIORITY||Risk Difference (RD)|0.23|||||TWO_SIDED|90.0|0.04|0.51||||||Risk difference and 2-sided 90% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.||0.51|0.04|
72445253|NCT04321031|144405489|SUPERIORITY||Risk Difference (RD)|0.37|||||TWO_SIDED|90.0|0.13|0.63||||||Risk difference and 2-sided 90% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.||0.63|0.13|
72445254|NCT04321031|144405489|SUPERIORITY||Risk Difference (RD)|0.22|||||TWO_SIDED|90.0|0.04|0.49||||||Risk difference and 2-sided 90% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.||0.49|0.04|
72445255|NCT04321031|144405489|SUPERIORITY||Risk Difference (RD)|0.54|||||TWO_SIDED|90.0|0.26|0.75||||||Risk difference and 2-sided 90% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.||0.75|0.26|
72445256|NCT04321031|144405489|SUPERIORITY||Risk Difference (RD)|0.34|||||TWO_SIDED|90.0|0.1|0.61||||||Risk difference and 2-sided 90% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.||0.61|0.10|
72445257|NCT04321031|144405489|SUPERIORITY||Risk Difference (RD)|0.48|||||TWO_SIDED|90.0|0.2|0.72||||||Risk difference and 2-sided 90% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.||0.72|0.20|
72445258|NCT04321031|144405489|SUPERIORITY||Risk Difference (RD)|0.32|||||TWO_SIDED|50.0|0.24|0.39||||||Risk difference and 2-sided 50% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.||0.39|0.24|
72445259|NCT04321031|144405489|SUPERIORITY||Risk Difference (RD)|0.32|||||TWO_SIDED|90.0|0.12|0.48||||||Risk difference and 2-sided 90% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.||0.48|0.12|
72445260|NCT04321031|144405489|SUPERIORITY||Risk Difference (RD)|0.14|||||TWO_SIDED|50.0|0.06|0.23||||||Risk difference and 2-sided 50% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.||0.23|0.06|
72445261|NCT04321031|144405489|SUPERIORITY||Risk Difference (RD)|0.14|||||TWO_SIDED|90.0|-0.06|0.33||||||Risk difference and 2-sided 90% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.||0.33|-0.06|
72445262|NCT04321031|144405490|SUPERIORITY||Risk Difference (RD)|-0.05|||||TWO_SIDED|90.0|-0.16|0.02|||||Reported values reflect a 90% Credible Interval rather than a 90% Confidence Interval.|The model was applied to the raw number of responders and non-responders utilizing a Bayesian methodology approach with non-informative priors as described in the SAP.||0.02|-0.16|
72497533|NCT02939131|144524903|SUPERIORITY||Mean Difference (Final Values)|2.8||||0.71|TWO_SIDED|95.0|-13.7|19.4|||t-test, 2 sided||A positive difference indicates the site-level averages were higher for the COMB-R group.|This is the analysis for week 24. Scores were averaged by site and the site-level averages were averaged and compared across treatment groups.||19.4|-13.7|0.71
72497534|NCT02939131|144524903|SUPERIORITY||Mean Difference (Final Values)|-4.7||||0.44|TWO_SIDED|95.0|-17.5|8.1|||t-test, 2 sided||A positive value would indicate site-level averages were higher in the COMB-R group.|This is the analysis for week 48. Scores were averaged by site and the site-level averages were averaged and compared across treatment groups.||8.1|-17.5|0.44
72497535|NCT02939131|144524904|SUPERIORITY||Mean Difference (Final Values)|7.3||||0.23|TWO_SIDED|95.0|-5.3|19.8|||t-test, 2 sided||A positive value would indicate site-level averages were higher in the COMB-R group.|This is the analysis for week 24. Scores were averaged by site and the site-level averages were averaged and compared across treatment groups.||19.8|-5.3|0.23
72445263|NCT04321031|144405490|SUPERIORITY||Risk Difference (RD)|-0.07|||||TWO_SIDED|90.0|-0.2|0.03|||||Reported values reflect a 90% Credible Interval rather than a 90% Confidence Interval.|The model was applied to the raw number of responders and non-responders utilizing a Bayesian methodology approach with non-informative priors as described in the SAP.||0.03|-0.20|
72497536|NCT02939131|144524904|SUPERIORITY||Mean Difference (Final Values)|-2.4||||0.73|TWO_SIDED|95.0|-17.5|12.7|||t-test, 2 sided||A positive difference would indicate site-level averages were higher in the COMB-R group.|This is the analysis for week 48. Scores were averaged by site and the site-level averages were averaged and compared across treatment groups.||12.7|-17.5|0.73
72497537|NCT02939131|144524905|SUPERIORITY||Mean Difference (Final Values)|0.5||||0.24|TWO_SIDED|95.0|-0.4|1.5|||t-test, 2 sided||A positive value would indicate site-level averages were higher in COMB-R group.|This is the analysis for week 24. Numbers of partners were averaged by site and the site-level averages were averaged and compared across treatment groups.||1.5|-0.4|0.24
72497538|NCT02939131|144524905|SUPERIORITY||Mean Difference (Final Values)|0.4||||0.22|TWO_SIDED|95.0|-0.3|1.0|||t-test, 2 sided||A positive difference indicates site-level averages were higher in the COMB-R group.|This is the analysis for week 48. Numbers of partners were averaged by site and the site-level averages were averaged and compared across treatment groups.||1.0|-0.3|0.22
72497539|NCT02939131|144524906|SUPERIORITY||Mean Difference (Final Values)|-8.3||||0.57|TWO_SIDED|95.0|-40.4|23.9|||t-test, 2 sided||A positive value would indicate higher site-level percents of low frequency condom use in COMB-R treatment group and vice versa.|This is the analysis for week 24 data. We computed the percent of participants reporting low frequency of condom use in past three months by site, averaged the site-level percents and compared these averages across treatment arms.||23.9|-40.4|0.57
72497540|NCT02939131|144524906|SUPERIORITY||Mean Difference (Final Values)|-21.8||||0.15|TWO_SIDED|95.0|-53.1|9.5|||t-test, 2 sided||A positive difference would indicate higher site-level percentages in the COMB-R group and vice versa.|This is the analysis for week 48 data. We computed the percent of participants reporting low frequency of condom use in past three months by site, averaged the site-level percents and compared these averages across treatment arms.||9.5|-53.1|0.15
72497541|NCT02939131|144524907|SUPERIORITY||Mean Difference (Final Values)|-6.8||||0.65|TWO_SIDED|95.0|-40.9|27.2|||t-test, 2 sided||A positive difference would indicate site level percents were higher in the COMB-R group and vice versa.|We computed the site-level percentages of participants reporting low frequency condom use at week 24, then averaged the site-level percentages by treatment group and compared these group average percents.||27.2|-40.9|0.65
72497542|NCT02939131|144524907|SUPERIORITY||Mean Difference (Final Values)|-37.8||||0.02|TWO_SIDED|95.0|-69.7|-5.8|||t-test, 2 sided||A positive difference would indicate site-level percentages were higher in the COMB-R group and vice versa.|We computed the site-level percentages of participants reporting low frequency condom use at week 48, then averaged the site-level percentages by treatment group and compared these group average percents.||-5.8|-69.7|0.02
72497543|NCT02939131|144524908|SUPERIORITY||Mean Difference (Final Values)|2.5||||0.33|TWO_SIDED|95.0|-3.0|8.1|||t-test, 2 sided||A positive difference indicates COMB-R participants attended more sessions than ESC|We averaged the number of counseling sessions for each site and compared these site-level averages.||8.1|-3.0|0.33
72497544|NCT02939131|144524913|SUPERIORITY||Mean Difference (Final Values)|18.7||||0.06|TWO_SIDED|95.0|-0.9|38.2|||t-test, 2 sided||A positive difference indicates more participants in the COMB-R group were taking medications, based on site-level percentages.|This is the analysis for the percent of participants on any psychiatric medication at week 24. Site-level percentages were compared across treatments.||38.2|-0.9|0.06
72497545|NCT02939131|144524913|SUPERIORITY||Mean Difference (Final Values)|17.4||||0.06|TWO_SIDED|95.0|-0.7|35.5|||t-test, 2 sided||A positive difference means the site-level percentages of those taking medications were higher in the COMB-R group.|This is the analysis of the percent of participants on antidepressant medications. Site-level percentages were compared across treatments.||35.5|-0.7|0.06
72497546|NCT02939131|144524913|SUPERIORITY||Mean Difference (Final Values)|22.4||||0.02|TWO_SIDED|95.0|4.2|40.6|||t-test, 2 sided||A positive difference indicates the site-level percentages of those taking medications were higher in the COMB-R group.|This is the analysis of the percent of participants on SSRI antidepressant medications. Site-level percentages were compared across treatments.||40.6|4.2|0.02
72445264|NCT04321031|144405490|SUPERIORITY||Risk Difference (RD)|-0.09|||||TWO_SIDED|90.0|-0.23|0.04|||||Reported values reflect a 90% Credible Interval rather than a 90% Confidence Interval.|The model was applied to the raw number of responders and non-responders utilizing a Bayesian methodology approach with non-informative priors as described in the SAP.||0.04|-0.23|
72445265|NCT04321031|144405490|SUPERIORITY||Risk Difference (RD)|-0.1|||||TWO_SIDED|90.0|-0.26|0.05|||||Reported values reflect a 90% Credible Interval rather than a 90% Confidence Interval.|The model was applied to the raw number of responders and non-responders utilizing a Bayesian methodology approach with non-informative priors as described in the SAP.||0.05|-0.26|
72445266|NCT04321031|144405491|SUPERIORITY||Risk Difference (RD)|-0.07|||||TWO_SIDED|90.0|-0.21|0.13||||||Risk difference and 2-sided 90% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.||0.13|-0.21|
72497547|NCT02939131|144524913|SUPERIORITY||Mean Difference (Final Values)|-3.9||||0.54|TWO_SIDED|95.0|-17.3|9.6|||t-test, 2 sided||A positive difference would indicate site-level percentages of those on medication were higher in the COMB-R group.|This is the analysis of the percent of participants on non-SSRI antidepressant medications. Site-level percentages were compared across treatments.||9.6|-17.3|0.54
72497548|NCT02939131|144524913|SUPERIORITY||Mean Difference (Final Values)|-5.0||||0.6|TWO_SIDED|95.0|-25.4|15.4|||t-test, 2 sided||A positive value would indicate the site-level percentages of those on medications were higher in the COMB-R group.|This is the analysis of the percent of participants on non-antidepressant psychiatric medications. Site-level percentages were compared across treatments.||15.4|-25.4|0.60
72497549|NCT02939131|144524914|SUPERIORITY||Mean Difference (Final Values)|-3.8||||0.77|TWO_SIDED|95.0|-32.5|24.8|||t-test, 2 sided||A positive difference would indicate more time on medication in the COMB-R group.|This is the analysis comparing site-level mean percents of study time on any psychiatric medication across treatment groups.||24.8|-32.5|0.77
72497550|NCT02939131|144524914|SUPERIORITY||Mean Difference (Final Values)|-1.9||||0.91|TWO_SIDED|95.0|-37.3|33.5|||t-test, 2 sided||A positive difference would indicate more study time on medication in the COMB-R group.|This is the analysis comparing site-level mean percents of study time on single SSRI psychiatric medication across treatment groups.||33.5|-37.3|0.91
72497551|NCT02939131|144524914|SUPERIORITY||Mean Difference (Final Values)|-16.7||||0.4|TWO_SIDED|95.0|-60.2|26.9|||t-test, 2 sided||A positive value would indicate more time on medication in the COMB-R group.|This is the analysis comparing site-level mean percents of study time on SSRI+other psychiatric medication across treatment groups.||26.9|-60.2|0.40
72497552|NCT02939131|144524914|SUPERIORITY||Mean Difference (Final Values)|-13.5||||0.52|TWO_SIDED|95.0|-67.0|40.1|||t-test, 2 sided||A positive difference would indicate more time on medication in COMB-R group.|This is the analysis comparing site-level mean percents of study time on a single non-SSRI psychiatric medication across treatment groups.||40.1|-67.0|0.52
72497553|NCT02939131|144524914|SUPERIORITY||Mean Difference (Final Values)|3.8||||0.96|TWO_SIDED|95.0|-778.0|785.7|||t-test, 2 sided|Because of sparseness, the confidence intervals for this site-level analysis are very large.|A positive difference indicates more time on medication in the COMB-R group. There was data from only one site in the ESC group and 2 sites in the COMB-R group. The confidence interval for the difference is quite large and the test is unreliable.|This is the analysis comparing site-level mean percents of study time on non-SSRI+other psychiatric medication across treatment groups. This analysis is unstable because of sparseness.||785.7|-778.0|0.96
72445267|NCT04321031|144405491|SUPERIORITY||Risk Difference (RD)|-0.14|||||TWO_SIDED|90.0|-0.25|0.02||||||Risk difference and 2-sided 90% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.||0.02|-0.25|
72445268|NCT04321031|144405491|SUPERIORITY||Risk Difference (RD)|-0.02|||||TWO_SIDED|90.0|-0.17|0.17||||||Risk difference and 2-sided 90% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.||0.17|-0.17|
72445269|NCT04321031|144405491|SUPERIORITY||Risk Difference (RD)|0.02|||||TWO_SIDED|90.0|-0.15|0.22||||||Risk difference and 2-sided 90% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.||0.22|-0.15|
72497554|NCT02939131|144524914|SUPERIORITY||Mean Difference (Final Values)|-4.2||||0.74|TWO_SIDED|95.0|-31.4|23.0|||t-test, 2 sided||A positive difference would reflect more time on medications in the COMB-R group|This is the analysis comparing site-level mean percents of study time on antidepressant medication across treatment groups.||23.0|-31.4|0.74
72445270|NCT04321031|144405491|SUPERIORITY||Risk Difference (RD)|-0.22|||||TWO_SIDED|90.0|-0.3|-0.05||||||Risk difference and 2-sided 90% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.||-0.05|-0.30|
72445271|NCT04321031|144405491|SUPERIORITY||Risk Difference (RD)|0.05|||||TWO_SIDED|90.0|-0.13|0.26||||||Risk difference and 2-sided 90% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.||0.26|-0.13|
72445272|NCT04321031|144405491|SUPERIORITY||Risk Difference (RD)|0.04|||||TWO_SIDED|50.0|-0.03|0.12||||||Risk difference and 2-sided 50% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.||0.12|-0.03|
72497555|NCT02939131|144524915|SUPERIORITY||Mean Difference (Final Values)|2.7||||0.29|TWO_SIDED|95.0|-2.8|8.2|||t-test, 2 sided||A positive difference would indicate the site level average interim counseling sessions was higher in the COMB-R group.|We compared the site-level average number of interim counseling sessions between treatment groups.||8.2|-2.8|0.29
72619275|NCT01654250|144769240|SUPERIORITY_OR_OTHER||LS Mean Difference|-12.3|STANDARD_ERROR_OF_MEAN|2.28|<|0.001|TWO_SIDED|95.0|-16.8|-7.8|||Mixed Models Analysis|||Hour 4 post-dose: Nominal p value-treatment comparisons for observed scores were assessed using a mixed model repeated measures analysis, with treatment (NWP09/Placebo), study center, time point and time point by treatment interaction as main effects and participant intercept as a random effect.||-7.8|-16.8|<0.001
72445273|NCT04321031|144405491|SUPERIORITY||Risk Difference (RD)|0.04|||||TWO_SIDED|90.0|-0.12|0.23||||||Risk difference and 2-sided 90% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.||0.23|-0.12|
72445274|NCT04321031|144405491|SUPERIORITY||Risk Difference (RD)|0.27|||||TWO_SIDED|50.0|0.17|0.38||||||Risk difference and 2-sided 50% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.||0.38|0.17|
72445275|NCT04321031|144405491|SUPERIORITY||Risk Difference (RD)|0.27|||||TWO_SIDED|90.0|0.06|0.53||||||Risk difference and 2-sided 90% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.||0.53|0.06|
72619276|NCT01654250|144769240|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Mixed Models Analysis|||Hour 4 post-dose: Adjusted p-values were generated using a fixed sequence testing procedure from p-values which were generated from the mixed effects model.||||<0.001
72619277|NCT01654250|144769240|SUPERIORITY_OR_OTHER||LS Mean Difference|-7.8|STANDARD_ERROR_OF_MEAN|2.28|<|0.001|TWO_SIDED|95.0|-12.3|-3.3|||Mixed Models Analysis|||Hour 8 post-dose: Nominal p value-treatment comparisons for observed scores were assessed using a mixed model repeated measures analysis, with treatment (NWP09/Placebo), study center, time point and time point by treatment interaction as main effect and participant intercept as a random effect.||-3.3|-12.3|<0.001
72619278|NCT01654250|144769240|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Mixed Models Analysis|||Hour 8 post-dose: Adjusted p-values were generated using a fixed sequence testing procedure from p-values which were generated from the mixed effects model.||||<0.001
72389613|NCT02465515|144287081|SUPERIORITY||Hazard Ratio (HR)|0.66||||0.055|TWO_SIDED|95.0|0.43|1.01||Two-sided p-value based on Wald test of HR=1 versus HR not equal to 1|Wald test||Hazard ratio is estimated using a Cox proportional hazard regression model with treatment as the only covariate.|||1.01|0.43|0.055
72389614|NCT02465515|144287082|OTHER||Mean Difference (Net)|-0.63|||<|0.001|TWO_SIDED|95.0|-0.69|-0.58||P-value from a two-sided t-test to test whether the difference of least square means (Albiglutide - Placebo) is equal to zero|t-test, 2 sided||Based on MMRM model: Change=Baseline HbA1c+Treatment+Visit+Treatment-by-Visit Interaction+Baseline HbA1c-by-Visit Interaction. Difference of least squares means (Albiglutide-Placebo) is from MMRM model for Month 8|||-0.58|-0.69|<0.001
72389615|NCT02465515|144287082|OTHER||Mean Difference (Net)|-0.52|||<|0.001|TWO_SIDED|95.0|-0.58|-0.45||P-value from a two-sided t-test to test whether the difference of least square means (Albiglutide - Placebo) is equal to zero|t-test, 2 sided||Based on MMRM model: Change=Baseline HbA1c+Treatment+Visit+Treatment-by-Visit Interaction+Baseline HbA1c-by-Visit Interaction. Difference of least squares means (Albiglutide-Placebo) is from MMRM model for Month 16|||-0.45|-0.58|<0.001
72389616|NCT02465515|144287083|OTHER||Mean Difference (Net)|-0.66|||<|0.001|TWO_SIDED|95.0|-0.83|-0.49||P-value from a two-sided t-test to test whether the difference of least square means (Albiglutide-Placebo) is equal to zero|t-test, 2 sided||Based on MMRM model: Change=Baseline Body Weight+Treatment+Visit+Treatment-by-Visit Interaction+Baseline Body Weight-by-Visit Interaction. Difference of least squares means (Albiglutide-Placebo) is from MMRM model for Month 8|||-0.49|-0.83|<0.001
72389617|NCT02465515|144287083|OTHER||Mean Difference (Net)|-0.83|||<|0.001|TWO_SIDED|95.0|-1.06|-0.6||P-value from a two-sided t-test to test whether the difference of least square means (Albiglutide - Placebo) is equal to zero|t-test, 2 sided||Based on MMRM model: Change=Baseline Body Weight+Treatment+Visit+Treatment-by-Visit Interaction+Baseline Body weight-by-Visit Interaction. Difference of least squares means (Albiglutide-Placebo) is from MMRM model for Month 16|||-0.60|-1.06|<0.001
72389618|NCT02465515|144287084|OTHER||Mean Difference (Net)|2.39|||<|0.001|TWO_SIDED|95.0|1.85|2.93||P-value from a two-sided t-test to test whether the difference of least square means (Albiglutide - Placebo) is equal to zero.|t-test, 2 sided||Based on MMRM model: Change=Baseline Total Score+Treatment+Visit+Treatment-by-Visit Interaction+Baseline Total Score-by-Visit Interaction. Difference of least squares means (Albiglutide-Placebo) is from MMRM model for Month 8|||2.93|1.85|<0.001
72389619|NCT02465515|144287084|OTHER||Mean Difference (Net)|2.33|||<|0.001|TWO_SIDED|95.0|1.66|3.01||P-value from a two-sided t-test to test whether the difference of least square means (Albiglutide-Placebo) is equal to zero|t-test, 2 sided||Based on MMRM model: Change=Baseline Total Score+Treatment+Visit+Treatment-by-Visit Interaction+Baseline Total Score-by-Visit Interaction. Difference of least squares means (Albiglutide-Placebo) is from MMRM model for Month 16|||3.01|1.66|<0.001
72389620|NCT02465515|144287085|OTHER||Mean Difference (Net)|1.47|||<|0.001|TWO_SIDED|95.0|0.87|2.07||P-value from a two-sided t-test to test whether the difference of least square means (Albiglutide-Placebo) is equal to zero.|t-test, 2 sided||Based on MMRM model: Change=Baseline Score+Treatment+Visit+Treatment-by-Visit Interaction+Baseline Score-by-Visit Interaction. Difference of least squares means (Albiglutide-Placebo) is from MMRM model for Month 8.|||2.07|0.87|<0.001
72389621|NCT02465515|144287085|OTHER||Mean Difference (Net)|0.52||||0.192|TWO_SIDED|95.0|-0.26|1.31||P-value from a two-sided t-test to test whether the difference of least square means (Albiglutide - Placebo) is equal to zero|t-test, 2 sided||Based on MMRM model: Change=Baseline Score+Treatment+Visit+Treatment-by-Visit Interaction+Baseline Score-by-Visit Interaction. Difference of least squares means (Albiglutide - Placebo) is from MMRM model for Month 16|||1.31|-0.26|0.192
72389622|NCT02465515|144287086|OTHER||Hazard Ratio (HR)|0.95||||0.644|TWO_SIDED|95.0|0.79|1.16||Two-sided p-value based on Wald test of HR=1 versus HR not equal to 1.|Wald test||Hazard ratio is estimated using a Cox proportional hazard regression model with treatment as the only covariate.|||1.16|0.79|0.644
72389623|NCT02465515|144287090|OTHER||Mean Difference (Net)|-1.11||||0.003|TWO_SIDED|95.0|-1.84|-0.39||P-value from a two-sided t-test to test whether the difference of least square means (Albiglutide-Placebo) is equal to zero.|t-test, 2 sided||Based on MMRM model: Change=Baseline eGFR+Treatment+Visit+Treatment-by-Visit Interaction+Baseline eGFR-by-Visit Interaction. Difference of least squares means (Albiglutide-Placebo) is from MMRM model for Month 8.|||-0.39|-1.84|0.003
72389624|NCT02465515|144287090|OTHER||Mean Difference (Net)|-0.43||||0.315|TWO_SIDED|95.0|-1.26|0.41||P-value from a two-sided t-test to test whether the difference of least square means (Albiglutide-Placebo) is equal to zero|t-test, 2 sided||Based on MMRM model: Change=Baseline eGFR+Treatment+Visit+Treatment-by-Visit Interaction+Baseline eGFR-by-Visit Interaction. Difference of least squares means (Albiglutide-Placebo) is from MMRM model for Month 16.|||0.41|-1.26|0.315
72389625|NCT00293033|144287093|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|9.74|STANDARD_ERROR_OF_MEAN|3.28||0.004|TWO_SIDED|95.0|3.31|16.18|||Mixed Models Analysis|The SPID was analyzed using a mixed model of repeated measures with fixed effects for treatment, pooled site, and a random effect for subjects.|Onsolis minus placebo|||16.18|3.31|0.004
72389626|NCT00293033|144287094|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.25|STANDARD_ERROR_OF_MEAN|0.33||0.44|TWO_SIDED|95.0|-0.4|0.91|||Wilcoxon (Mann-Whitney)|||||0.91|-0.40|0.440
72389627|NCT00293033|144287095|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.94|STANDARD_ERROR_OF_MEAN|0.7||0.179|TWO_SIDED|95.0|-0.44|2.33|||Mixed Models Analysis|||||2.33|-0.44|0.179
72389628|NCT00293033|144287096|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.32|STANDARD_ERROR_OF_MEAN|1.16||0.047|TWO_SIDED|95.0|0.04|4.61|||Mixed Models Analysis|||||4.61|0.04|0.047
72389629|NCT00293033|144287097|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|19.68|STANDARD_ERROR_OF_MEAN|5.7|<|0.001|TWO_SIDED|95.0|8.5|30.86|||Mixed Models Analysis|||||30.86|8.50|<0.001
72389630|NCT00293033|144287098|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|31.98|STANDARD_ERROR_OF_MEAN|8.23|<|0.001|TWO_SIDED|95.0|15.85|48.12|||Mixed Models Analysis|||||48.12|15.85|<0.001
72389631|NCT00293033|144287099|SUPERIORITY_OR_OTHER_LEGACY|||||||0.517|||||||Wilcoxon (Mann-Whitney)|||||||0.517
72389632|NCT00293033|144287100|SUPERIORITY_OR_OTHER_LEGACY|||||||0.458|||||||Wilcoxon (Mann-Whitney)|||||||0.458
72389633|NCT00293033|144287101|SUPERIORITY_OR_OTHER_LEGACY|||||||0.223|||||||Wilcoxon (Mann-Whitney)|||||||0.223
72389634|NCT00293033|144287102|SUPERIORITY_OR_OTHER_LEGACY|||||||0.015|||||||Wilcoxon (Mann-Whitney)|||||||0.015
72389635|NCT00293033|144287103|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||||||0.001
72389636|NCT00293033|144287104|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
72389637|NCT00293033|144287105|SUPERIORITY_OR_OTHER_LEGACY|||||||0.193|||||||Wilcoxon (Mann-Whitney)|||||||0.193
72389638|NCT00293033|144287106|SUPERIORITY_OR_OTHER_LEGACY|||||||0.113|||||||Wilcoxon (Mann-Whitney)|||||||0.113
72389639|NCT00293033|144287107|SUPERIORITY_OR_OTHER_LEGACY|||||||0.192|||||||Wilcoxon (Mann-Whitney)|||||||0.192
72389640|NCT00293033|144287108|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002|||||||Wilcoxon (Mann-Whitney)|||||||0.002
72389641|NCT00293033|144287109|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002|||||||Wilcoxon (Mann-Whitney)|||||||0.002
72389642|NCT00293033|144287110|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
72389643|NCT00293033|144287111|SUPERIORITY_OR_OTHER_LEGACY|||||||0.157|||||||Wilcoxon (Mann-Whitney)|||||||0.157
72389644|NCT00293033|144287112|SUPERIORITY_OR_OTHER_LEGACY|||||||0.278|||||||Wilcoxon (Mann-Whitney)|||||||0.278
72389645|NCT00293033|144287113|SUPERIORITY_OR_OTHER_LEGACY|||||||0.062|||||||Wilcoxon (Mann-Whitney)|||||||0.062
72389646|NCT00293033|144287114|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002|||||||Wilcoxon (Mann-Whitney)|||||||0.002
72389647|NCT00293033|144287115|SUPERIORITY_OR_OTHER_LEGACY|||||||0.005|||||||Wilcoxon (Mann-Whitney)|||||||0.005
72389648|NCT00293033|144287116|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||||||0.001
72389649|NCT00293033|144287117|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
72389650|NCT00293033|144287118|SUPERIORITY_OR_OTHER_LEGACY|||||||1|||||||Wilcoxon (Mann-Whitney)|||||||1.000
72389651|NCT00293033|144287119|SUPERIORITY_OR_OTHER_LEGACY|||||||1|||||||Wilcoxon (Mann-Whitney)|||||||1.000
72389652|NCT00293033|144287120|SUPERIORITY_OR_OTHER_LEGACY|||||||0.563|||||||Wilcoxon (Mann-Whitney)|||||||0.563
72389653|NCT00293033|144287121|SUPERIORITY_OR_OTHER_LEGACY|||||||0.498|||||||Wilcoxon (Mann-Whitney)|||||||0.498
72389654|NCT00293033|144287122|SUPERIORITY_OR_OTHER_LEGACY|||||||0.077|||||||Wilcoxon (Mann-Whitney)|||||||0.077
72389655|NCT00293033|144287123|SUPERIORITY_OR_OTHER_LEGACY|||||||0.031|||||||Wilcoxon (Mann-Whitney)|||||||0.031
72389656|NCT00293033|144287124|SUPERIORITY_OR_OTHER_LEGACY|||||||0.963|||||||Wilcoxon (Mann-Whitney)|||||||0.963
72389657|NCT00293033|144287125|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002|||||||Wilcoxon (Mann-Whitney)|||||||0.002
72389658|NCT00293033|144287126|SUPERIORITY_OR_OTHER_LEGACY|||||||0.008|||||||Wilcoxon (Mann-Whitney)|||||||0.008
72389659|NCT00293033|144287127|SUPERIORITY_OR_OTHER_LEGACY|||||||0.005|||||||Wilcoxon (Mann-Whitney)|||||||0.005
72389660|NCT00293033|144287128|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1|||||||Wilcoxon (Mann-Whitney)|||||||0.100
72389661|NCT00293033|144287129|SUPERIORITY_OR_OTHER_LEGACY|||||||0.009|||||||Wilcoxon (Mann-Whitney)|||||||0.009
72389662|NCT00293033|144287130|SUPERIORITY_OR_OTHER_LEGACY|||||||0.004|||||||Wilcoxon (Mann-Whitney)|||||||0.004
72389663|NCT00293033|144287131|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
72389664|NCT00293033|144287132|SUPERIORITY_OR_OTHER_LEGACY|||||||1|||||||Wilcoxon (Mann-Whitney)|||||||1.000
72389665|NCT00293033|144287133|SUPERIORITY_OR_OTHER_LEGACY|||||||1|||||||Wilcoxon (Mann-Whitney)|||||||1.000
72389666|NCT00293033|144287134|SUPERIORITY_OR_OTHER_LEGACY|||||||0.75|||||||Wilcoxon (Mann-Whitney)|||||||0.750
72389667|NCT00293033|144287135|SUPERIORITY_OR_OTHER_LEGACY|||||||0.032|||||||Wilcoxon (Mann-Whitney)|||||||0.032
72389668|NCT00293033|144287136|SUPERIORITY_OR_OTHER_LEGACY|||||||0.131|||||||Wilcoxon (Mann-Whitney)|||||||0.131
72389669|NCT00293033|144287137|SUPERIORITY_OR_OTHER_LEGACY|||||||0.007|||||||Wilcoxon (Mann-Whitney)|||||||0.007
72389670|NCT00293033|144287138|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002|||||||Wilcoxon (Mann-Whitney)|||||||0.002
72389671|NCT00293033|144287139|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.96|STANDARD_ERROR_OF_MEAN|2.57||0.023|TWO_SIDED|95.0|0.92|11.01|||Mixed Models Analysis|||||11.01|0.92|0.023
72389672|NCT00293033|144287140|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|19.84|STANDARD_ERROR_OF_MEAN|7.25||0.009|TWO_SIDED|95.0|5.63|34.04|||Mixed Models Analysis|||||34.04|5.63|0.009
72389673|NCT00293033|144287141|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|33.26|STANDARD_ERROR_OF_MEAN|12.72||0.012|TWO_SIDED|95.0|8.32|58.2|||Mixed Models Analysis|||||58.20|8.32|0.012
72389674|NCT00293033|144287142|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|46.88|STANDARD_ERROR_OF_MEAN|18.46||0.015|TWO_SIDED|95.0|10.69|83.08|||Mixed Models Analysis|||||83.08|10.69|0.015
72389675|NCT03583697|144287147|SUPERIORITY||Least Square Mean Difference (Net)|0.25|||||TWO_SIDED|95.0|-0.02|0.53||||||"Z-Scores were derived using age-sex specific reference data (means and SDs) for average stature children per the Centers for Disease Control and Prevention.~Participants aged \< 24 months, body length takes precedence over standing height. Participants aged \< 24 months at baseline and \>= 24 months at Week 52, body length takes precedence.~Difference in least squares (LS) means were obtained from an analysis of covariance model."||0.53|-0.02|
72389676|NCT03583697|144287147|SUPERIORITY||Least Square Mean Difference (Net)|0.3|||||TWO_SIDED|95.0|0.07|0.54||||||"Z-Scores were derived using age-sex specific reference data (means and SDs) for average stature children per the Centers for Disease Control and Prevention.~Participants aged \< 24 months, body length takes precedence over standing height. Participants aged \< 24 months at baseline and \>= 24 months at Week 52, body length takes precedence.~Difference in LS means were obtained from an analysis of covariance model."||0.54|0.07|
72389677|NCT03583697|144287148|SUPERIORITY||Least Square Mean Difference (Net)|0.77|||||TWO_SIDED|95.0|-0.02|1.56||||||Difference in LS means were obtained from an analysis of covariance model.||1.56|-0.02|
72445276|NCT04321031|144405492|SUPERIORITY||Risk Difference (RD)|0.03|||||TWO_SIDED|90.0|-0.01|0.08|||||Reported values reflect a 90% Credible Interval rather than a 90% Confidence Interval.|The model was applied to the raw number of responders and non-responders utilizing a Bayesian methodology approach with non-informative priors as described in the SAP.||0.08|-0.01|
72445277|NCT04321031|144405492|SUPERIORITY||Risk Difference (RD)|0.04|||||TWO_SIDED|90.0|-0.02|0.09|||||Reported values reflect a 90% Credible Interval rather than a 90% Confidence Interval.|The model was applied to the raw number of responders and non-responders utilizing a Bayesian methodology approach with non-informative priors as described in the SAP.||0.09|-0.02|
72445278|NCT04321031|144405492|SUPERIORITY||Risk Difference (RD)|0.05|||||TWO_SIDED|90.0|-0.02|0.11|||||Reported values reflect a 90% Credible Interval rather than a 90% Confidence Interval.|The model was applied to the raw number of responders and non-responders utilizing a Bayesian methodology approach with non-informative priors as described in the SAP.||0.11|-0.02|
72445279|NCT04321031|144405492|SUPERIORITY||Risk Difference (RD)|0.05|||||TWO_SIDED|90.0|-0.02|0.12|||||Reported values reflect a 90% Credible Interval rather than a 90% Confidence Interval.|The model was applied to the raw number of responders and non-responders utilizing a Bayesian methodology approach with non-informative priors as described in the SAP.||0.12|-0.02|
72445280|NCT04321031|144405493|SUPERIORITY||Risk Difference (RD)|0.09|||||TWO_SIDED|90.0|-0.01|0.43||||||Risk difference and 2-sided 90% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.||0.43|-0.01|
72445281|NCT04321031|144405493|SUPERIORITY||Risk Difference (RD)|0.03|||||TWO_SIDED|90.0|-0.02|0.29||||||Risk difference and 2-sided 90% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.||0.29|-0.02|
72445282|NCT04321031|144405493|SUPERIORITY||Risk Difference (RD)|0.09|||||TWO_SIDED|90.0|-0.01|0.43||||||Risk difference and 2-sided 90% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.||0.43|-0.01|
72445283|NCT04321031|144405493|SUPERIORITY||Risk Difference (RD)|0.17|||||TWO_SIDED|90.0|0.01|0.57||||||Risk difference and 2-sided 90% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.||0.57|0.01|
72445284|NCT04321031|144405493|SUPERIORITY||Risk Difference (RD)|0.04|||||TWO_SIDED|90.0|-0.02|0.33||||||Risk difference and 2-sided 90% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.||0.33|-0.02|
72445285|NCT04321031|144405493|SUPERIORITY||Risk Difference (RD)|0.17|||||TWO_SIDED|90.0|0.01|0.58||||||Risk difference and 2-sided 90% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.||0.58|0.01|
72445286|NCT04321031|144405493|SUPERIORITY||Risk Difference (RD)|0.08|||||TWO_SIDED|50.0|0.02|0.16||||||Risk difference and 2-sided 50% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.||0.16|0.02|
72445287|NCT04321031|144405493|SUPERIORITY||Risk Difference (RD)|0.08|||||TWO_SIDED|90.0|-0.04|0.3||||||Risk difference and 2-sided 90% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.||0.30|-0.04|
72445288|NCT04321031|144405493|SUPERIORITY||Risk Difference (RD)|0.13|||||TWO_SIDED|50.0|0.06|0.24||||||Risk difference and 2-sided 50% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.||0.24|0.06|
72445289|NCT04321031|144405493|SUPERIORITY||Risk Difference (RD)|0.13|||||TWO_SIDED|90.0|-0.01|0.44||||||Risk difference and 2-sided 90% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.||0.44|-0.01|
72445290|NCT04321031|144405494|SUPERIORITY||Risk Difference (RD)|0.18|||||TWO_SIDED|90.0|0.05|0.31|||||Reported values reflect a 90% Credible Interval rather than a 90% Confidence Interval.|The model was applied to the raw number of responders and non-responders utilizing a Bayesian methodology approach with non-informative priors as described in the SAP.||0.31|0.05|
72445291|NCT04321031|144405494|SUPERIORITY||Risk Difference (RD)|0.23|||||TWO_SIDED|90.0|0.09|0.36|||||Reported values reflect a 90% Credible Interval rather than a 90% Confidence Interval.|The model was applied to the raw number of responders and non-responders utilizing a Bayesian methodology approach with non-informative priors as described in the SAP.||0.36|0.09|
72445292|NCT04321031|144405494|SUPERIORITY||Risk Difference (RD)|0.25|||||TWO_SIDED|90.0|0.1|0.38|||||Reported values reflect a 90% Credible Interval rather than a 90% Confidence Interval.|The model was applied to the raw number of responders and non-responders utilizing a Bayesian methodology approach with non-informative priors as described in the SAP.||0.38|0.10|
72445293|NCT04321031|144405494|SUPERIORITY||Risk Difference (RD)|0.27|||||TWO_SIDED|90.0|0.11|0.4|||||Reported values reflect a 90% Credible Interval rather than a 90% Confidence Interval.|The model was applied to the raw number of responders and non-responders utilizing a Bayesian methodology approach with non-informative priors as described in the SAP.||0.40|0.11|
72445294|NCT04321031|144405495|SUPERIORITY||Risk Difference (RD)|0.14|||||TWO_SIDED|90.0|-0.04|0.36||||||Risk difference and 2-sided 90% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.||0.36|-0.04|
72445295|NCT04321031|144405495|SUPERIORITY||Risk Difference (RD)|0.35|||||TWO_SIDED|90.0|0.15|0.53||||||Risk difference and 2-sided 90% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.||0.53|0.15|
72445296|NCT04321031|144405495|SUPERIORITY||Risk Difference (RD)|0.26|||||TWO_SIDED|90.0|0.06|0.46||||||Risk difference and 2-sided 90% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.||0.46|0.06|
72445297|NCT04321031|144405495|SUPERIORITY||Risk Difference (RD)|0.48|||||TWO_SIDED|90.0|0.27|0.63||||||Risk difference and 2-sided 90% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.||0.63|0.27|
72619279|NCT01654250|144769240|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.4|STANDARD_ERROR_OF_MEAN|2.28||0.133|TWO_SIDED|95.0|-7.9|1.1|||Mixed Models Analysis|||Hour 10 post-dose: Nominal p-value -treatment comparisons for observed scores were assessed using a mixed model repeated measures analysis, with treatment (NWP09/Placebo), study center, time point and time point by treatment interaction as main effects and participant intercept as a random effect.||1.1|-7.9|0.133
72389678|NCT03583697|144287148|SUPERIORITY||Least Square Mean Difference (Net)|0.96|||||TWO_SIDED|95.0|0.26|1.66||||||Difference in LS means were obtained from an analysis of covariance model.||1.66|0.26|
72560690|NCT00830167|144651717|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.68|STANDARD_ERROR_OF_MEAN|1.84||0.1805|TWO_SIDED|95.0|-1.93|5.29||The analysis was conducted using 1-sided test with the significance level of 0.025.|ANCOVA|||The null hypothesis was to assume that there was no difference between the pregabalin and placebo groups. The alternative was that the pregabalin group was superior to the placebo group.||5.29|-1.93|0.1805
72560691|NCT00830167|144651718|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.15|STANDARD_ERROR_OF_MEAN|1.5||0.077|TWO_SIDED|95.0|-0.81|5.1||The analysis was conducted using 1-sided test with the significance level of 0.025.|ANCOVA|||The null hypothesis was to assume that there was no difference between the pregabalin and placebo groups. The alternative was that the pregabalin group was superior to the placebo group.||5.10|-0.81|0.0770
72560692|NCT00830167|144651719|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.83|STANDARD_ERROR_OF_MEAN|1.2||0.0648|TWO_SIDED|95.0|-0.54|4.19||The analysis was conducted using 1-sided test with the significance level of 0.025.|ANCOVA|||The null hypothesis was to assume that there was no difference between the pregabalin and placebo groups. The alternative was that the pregabalin group was superior to the placebo group.||4.19|-0.54|0.0648
72560693|NCT00830167|144651720|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.59|STANDARD_ERROR_OF_MEAN|1.94||0.2068|TWO_SIDED|95.0|-2.23|5.41||The analysis was conducted using 1-sided test with the significance level of 0.025.|ANCOVA|||The null hypothesis was to assume that there was no difference between the pregabalin and placebo groups. The alternative was that the pregabalin group was superior to the placebo group.||5.41|-2.23|0.2068
72560694|NCT00830167|144651721|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.23|STANDARD_ERROR_OF_MEAN|1.92||0.548|TWO_SIDED|95.0|-4.0|3.54||The analysis was conducted using 1-sided test with the significance level of 0.025.|ANCOVA|||The null hypothesis was to assume that there was no difference between the pregabalin and placebo groups. The alternative was that the pregabalin group was superior to the placebo group.||3.54|-4.00|0.5480
72560695|NCT00830167|144651722|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.42|STANDARD_ERROR_OF_MEAN|1.72||0.0052|TWO_SIDED|95.0|1.04|7.8||The analysis was conducted using 1-sided test with the significance level of 0.025.|ANCOVA|||The null hypothesis was to assume that there was no difference between the pregabalin and placebo groups. The alternative was that the pregabalin group was superior to the placebo group.||7.80|1.04|0.0052
72560696|NCT00830167|144651723|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.64|STANDARD_ERROR_OF_MEAN|1.39||0.0287|TWO_SIDED|95.0|-0.08|5.37||The analysis was conducted using 1-sided test with the significance level of 0.025.|ANCOVA|||The null hypothesis was to assume that there was no difference between the pregabalin and placebo groups. The alternative was that the pregabalin group was superior to the placebo group.||5.37|-0.08|0.0287
72389679|NCT03583697|144287149|SUPERIORITY||Least Square Mean Difference (Net)|0.78|||||TWO_SIDED|95.0|0.02|1.54||||||||1.54|0.02|
72389680|NCT03583697|144287149|SUPERIORITY||Least Square Mean Difference (Net)|0.92|||||TWO_SIDED|95.0|0.24|1.59||||||Difference in LS means were obtained from an analysis of covariance model.||1.59|0.24|
72389681|NCT03583697|144287150|SUPERIORITY||Least Square Mean Difference (Net)|-0.07|||||TWO_SIDED|95.0|-0.17|0.04||||||Difference in LS means were obtained from an analysis of covariance model.||0.04|-0.17|
72389682|NCT03583697|144287150|SUPERIORITY||Least Square Mean Difference (Net)|-0.06|||||TWO_SIDED|95.0|-0.15|0.03||||||Difference in LS means were obtained from an analysis of covariance model.||0.03|-0.15|
72389683|NCT00679432|144287204|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportions|5.8||||0.1393|TWO_SIDED|95.0|-1.8|13.4|||Chi-squared||The difference in proportions was determined by subtracting the proportion of patients who reached the endpoint in the placebo group from that proportion in the active group (active minus placebo).|All p-values were based on the Chi-square test; comparisons of budesonide MMX and placebo were conducted at the α = 0.025 level of significance and the comparison of Asacol and placebo were conducted at the α = 0.05 level of significance. The study was not powered to show statistical significance for Asacol versus budesonide MMX.||13.4|-1.8|0.1393
72389684|NCT00679432|144287204|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportions|10.4||||0.0143|TWO_SIDED|95.0|2.2|18.7|||Chi-squared||See comments from the budesonide 6 mg versus placebo comparison (statistical analysis 1).|See comments from the budesonide 6 mg versus placebo comparison (statistical analysis 1).||18.7|2.2|0.0143
72560697|NCT00830167|144651724|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.48|STANDARD_ERROR_OF_MEAN|0.25||0.0262|TWO_SIDED|95.0|-0.97|0.01||The analysis was conducted using 1-sided test with the significance level of 0.025.|ANCOVA|||The null hypothesis was to assume that there was no difference between the pregabalin and placebo groups. The alternative was that the pregabalin group was superior to the placebo group.||0.01|-0.97|0.0262
72560698|NCT00830167|144651725|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.28|STANDARD_ERROR_OF_MEAN|0.28||0.1561|TWO_SIDED|95.0|-0.83|0.27||The analysis was conducted using 1-sided test with the significance level of 0.025.|ANCOVA|||The null hypothesis was to assume that there was no difference between the pregabalin and placebo groups. The alternative was that the pregabalin group was superior to the placebo group.||0.27|-0.83|0.1561
72619280|NCT01654250|144769240|SUPERIORITY_OR_OTHER|||||||0.133|||||||Mixed Models Analysis|||Hour 10 post-dose: Adjusted p-value were generated using a fixed sequence testing procedure from p-values generated from the mixed effects model.||||0.133
72445298|NCT04321031|144405495|SUPERIORITY||Risk Difference (RD)|0.16|||||TWO_SIDED|90.0|-0.03|0.38||||||Risk difference and 2-sided 90% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.||0.38|-0.03|
72445299|NCT04321031|144405495|SUPERIORITY||Risk Difference (RD)|0.4|||||TWO_SIDED|90.0|0.18|0.58||||||Risk difference and 2-sided 90% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.||0.58|0.18|
72445300|NCT04321031|144405495|SUPERIORITY||Risk Difference (RD)|0.22|||||TWO_SIDED|50.0|0.15|0.28||||||Risk difference and 2-sided 50% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.||0.28|0.15|
72497556|NCT02939131|144524917|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.03|TWO_SIDED|95.0|0.02|0.38|||t-test, 2 sided||A positive difference indicates higher site-level averages in the COMB-R group.|The average score for all participants at each site was computed. These site-level averages were compared across treatment groups.||0.38|0.02|0.03
72497557|NCT02939131|144524918|SUPERIORITY||Mean Difference (Final Values)|-0.07||||0.69|TWO_SIDED|95.0|-0.43|0.29|||t-test, 2 sided||A positive difference would indicate the site-level averages were higher in the COMB-R group compared to the ESC group and vice versa|The average of scores for all participants' clinicians at each site was computed and these site-level averages were compared across treatments.||0.29|-0.43|0.69
72497558|NCT02939131|144524919|SUPERIORITY||Mean Difference (Final Values)|0.65||||0.004|TWO_SIDED|95.0|0.26|1.03|||t-test, 2 sided||A positive difference would indicate site-level averages were higher for the COMB-R group than the ESC group and vice versa.|The average scores for all participants' prescribing clinicians at each site were computed and these site-level averages were compared across treatment groups.||1.03|0.26|0.004
72497559|NCT02939131|144524920|SUPERIORITY|We tested the null hypothesis that the treatment group means were equal vs. not.|Mean Difference (Final Values)|0.16||||0.98|TWO_SIDED|95.0|-14.04|14.36|||t-test, 2 sided||We subtract group mean for ESC from group mean for COMB-R. The group means are the means of the site-level percentages of participants with events.|This is the analysis of new Grade 3+ signs/symptoms through week 24. The percent of participants at each site with at least one such event was computed. The average of these site-level percents was calculated for each treatment arm. These averages were compared.||14.36|-14.04|0.98
72497560|NCT02939131|144524920|SUPERIORITY|We tested the null hypothesis that the treatment group means were equal vs. not.|Mean Difference (Final Values)|2.57||||0.6|TWO_SIDED|95.0|-7.85|12.98|||t-test, 2 sided||We subtracted the group mean for the ESC group from that of the COMB-R group. The group mean is the mean of the site-specific percentages of participants with events.|This is the analysis of new Grade 3+ diagnoses through week 24.The percent of participants at each site with at least one such event was computed. The average of these site-level percents was calculated for each treatment arm. These averages were compared.||12.98|-7.85|0.60
72619281|NCT01654250|144769240|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.9|STANDARD_ERROR_OF_MEAN|2.28||0.206|TWO_SIDED|95.0|-7.4|1.6|||Mixed Models Analysis|||Hour 12 post-dose: Nominal p value-treatment comparisons for observed scores were assessed using a mixed model repeated measures analysis, with treatment (NWP09/Placebo), study center, time point and time point by treatment interaction as main effects and participant intercept as a random effect.||1.6|-7.4|0.206
72445301|NCT04321031|144405495|SUPERIORITY||Risk Difference (RD)|0.22|||||TWO_SIDED|90.0|0.03|0.35||||||Risk difference and 2-sided 90% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.||0.35|0.03|
72445302|NCT04321031|144405495|SUPERIORITY||Risk Difference (RD)|0.24|||||TWO_SIDED|50.0|0.16|0.32||||||Risk difference and 2-sided 50% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.||0.32|0.16|
72619282|NCT01654250|144769240|SUPERIORITY_OR_OTHER|||||||0.133|||||||Mixed Models Analysis|||Hour 12 post-dose: Adjusted p-values are generated using a fixed sequence testing procedure from p-values which were generated from the mixed effects model.||||0.133
72445303|NCT04321031|144405495|SUPERIORITY||Risk Difference (RD)|0.24|||||TWO_SIDED|90.0|0.03|0.42||||||Risk difference and 2-sided 90% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.||0.42|0.03|
72445304|NCT02736409|144405501|SUPERIORITY||Difference in Proportion|-0.19||||0.131|TWO_SIDED|95.0|-0.452|0.082|||Fisher Exact|||||0.082|-0.452|0.131
72445305|NCT05285618|144405546|OTHER|A linear mixed model accounted for repeated measures ('subject\_id' as a random factor). No power calculation was performed, but the sample size (1,485 observations, 6 subjects) supports robust estimation.||||||0.002||||||P-values are unadjusted for multiple comparisons, as the analysis focused on a limited number of predictors. The a priori threshold for statistical significance was set at p\<0.05.|Mixed Models Analysis|||The model tested whether stimulation delay ('abs\_delay'), retinal distance ('dist\_ret'), and their interaction ('abs\_delay:dist\_ret') affect the number of elicited phosphenes ('num\_phosphenes').|We hypothesize that the parameter 'dist\_ret' may influence the number of phosphenes perceived ('num\_phosphenes'), while the roles of 'abs\_delay' and its interaction with 'dist\_ret' may be less pronounced. Further evaluation of these parameters will be conducted in the Results section|||0.002
72445306|NCT05722704|144405549|SUPERIORITY||Median Difference (Net)|0.118|STANDARD_DEVIATION|0.05||0.986|TWO_SIDED|95.0|||||Kruskal-Wallis|||||||0.986
72445307|NCT05722704|144405550|SUPERIORITY||Median Difference (Net)|0.016|STANDARD_DEVIATION|0.05|<|0.118|TWO_SIDED|95.0|||||Kruskal-Wallis|||||||<0.118
72445308|NCT05722704|144405551|SUPERIORITY||Median Difference (Net)|95.0|STANDARD_DEVIATION|0.05||0.225|TWO_SIDED|95.0|||||Kruskal-Wallis|||||||0.225
72445309|NCT05722704|144405552|SUPERIORITY||Median Difference (Net)|95.0|STANDARD_DEVIATION|0.05||0.424|TWO_SIDED|95.0|||||Kruskal-Wallis|||||||0.424
72445310|NCT05671029|144405611|NON_INFERIORITY|Null hypothesis: difference to placebo of change from baseline QTcF ≥ 10 ms.|Prediction @ mean max concentration|0.8|||<|0.05|TWO_SIDED|90.0|-1.3|2.9|||Mixed Models Analysis|||||2.9|-1.3|<0.05
72445311|NCT05481216|144405657|OTHER|Unadjusted and adjusted hazard ratios (HR) will be calculated using a proportional Cox regression model. The adjusted variables were body mass index (BMI), dementia, peripheral vascular disease, history of pneumonia, connective tissue disease, liver disease, diabetes, chronic kidney disease, glucocorticoids, hydroxychloroquine, tocilizumab, and anti-IL6 inhibitors.|Hazard Ratio (HR)|1.3|||||TWO_SIDED|95.0|0.73|2.29||||||||2.29|0.73|
72497561|NCT02939131|144524920|SUPERIORITY|We tested the null hypothesis that the treatment group means were equal vs. not.The group mean is the mean of the site-specific percentages of participants with events as defined above.|Mean Difference (Final Values)|4.4||||0.17|TWO_SIDED|95.0|-2.21|11.02|||t-test, 2 sided||The ESC group mean percent of participants reporting a trigger event was subtracted from the COMB-R group mean.|This is the analysis of the triggering events (psychiatric hospitalizations or suicide attempts) through week 24. A participant is counted once if they had reported any such event prior to the upper bound of the week 24 window. The percent of participants at each site with at least one such event were computed.The average of these site-level percents was calculated for each treatment arm. These averages were compared.||11.02|-2.21|0.17
72497562|NCT02939131|144524921|SUPERIORITY||Mean Difference (Final Values)|0.14||||0.98|TWO_SIDED|95.0|-13.85|14.13|||t-test, 2 sided||A positive difference indicates more participants with events in the COMB-R group.|This is the analysis of new Grade 3+ signs/symptoms through week 48. The percent of participants at each site with at least one such event was computed. The average of these site-level percents was calculated for each treatment arm. These averages were compared.||14.13|-13.85|0.98
72497563|NCT02939131|144524921|SUPERIORITY||Mean Difference (Final Values)|5.64||||0.4|TWO_SIDED|95.0|-8.6|19.89|||t-test, 2 sided||A positive difference indicates more participants with events in the COMB-R group.|This is the analysis of new Grade 3+ diagnoses through week 48. The percent of participants at each site with at least one such event was computed. The average of these site-level percents was calculated for each treatment arm. These averages were compared.||19.89|-8.60|0.40
72497564|NCT02939131|144524921|SUPERIORITY||Mean Difference (Final Values)|3.01||||0.44|TWO_SIDED|95.0|-5.27|11.29|||t-test, 2 sided||A positive difference indicates more participants with events in the COMB-R group.|This is the analysis of new trigger events through week 48. The percent of participants at each site with at least one such event was computed. The average of these site-level percents was calculated for each treatment arm. These averages were compared.||11.29|-5.27|0.44
72497565|NCT03990870|144524931|SUPERIORITY|||||||0.58|||||||t-test, 2 sided|||||||0.58
72497566|NCT03990870|144524934|SUPERIORITY|||||||0.35|||||||t-test, 2 sided|||||||0.35
72497567|NCT03990870|144524936|SUPERIORITY|||||||0.95|||||||Chi-squared|||||||0.95
72497568|NCT01989221|144524937|SUPERIORITY||Mean Difference (Final Values)|0.55|STANDARD_DEVIATION|0.12|<|0.01|TWO_SIDED|95.0||||Threshold for statistical significance was p \< 0.05.|t-test, 2 sided||Mean GCSI-DD scores during one week at baseline were compared to mean GCSI-DD scores during the second week of Sancuso treatment.|||||<0.01
72497569|NCT01989221|144524938|OTHER||Mean Difference (Final Values)|1.01|STANDARD_DEVIATION|0.27|<|0.01|TWO_SIDED|95.0||||Threshold for statistical significance was p \< 0.05|t-test, 2 sided||Mean nausea and vomiting symptom scores during one week at baseline were compared to mean symptom scores during the second week of Sancuso treatment.|||||<0.01
72497570|NCT01279057|144524939|EQUIVALENCE|If the 90% confidence intervals were contained within the interval 80.0% to 125.0%, then the two products were considered to be therapeutically equivalent.|Ratio Test/Ref. Least Squares (LS) Means|104.085|||||TWO_SIDED|90.0|87.421|124.21||||||||124.210|87.421|
72497571|NCT01279057|144524940|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
72497572|NCT01279057|144524940|SUPERIORITY|||||||0.0001|||||||ANCOVA|||||||0.0001
72497573|NCT01279057|144524941|EQUIVALENCE|90% confidence intervals within the interval 80.0% to 125.0%.|Ratio Test/Ref. LS Means|106.635|||||TWO_SIDED|90.0|89.256|127.79||||||||127.790|89.256|
72497574|NCT01279057|144524942|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
72497575|NCT01279057|144524942|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
72369835|NCT04881942|144250145|EQUIVALENCE|"Null Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is equal to 0.~Alternate Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is not equal to 0."|Mean Difference (Net)|195.7|||<|0.0001|TWO_SIDED|95.0|122.01|269.38|||ANCOVA||Mean value is sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham).|"Null Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is equal to 0.~Alternate Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is not equal to 0."||269.38|122.01|<.0001
72497576|NCT01279057|144524943|EQUIVALENCE|90% confidence intervals within the interval 80.0% to 125.0%.|Ratio Test/Ref. LS Means|115.877|||||TWO_SIDED|90.0|94.129|143.949||||||||143.949|94.129|
72560699|NCT00830167|144651726|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.19|STANDARD_ERROR_OF_MEAN|2.04||0.0013|TWO_SIDED|95.0|-10.2|-2.18||The analysis was conducted using 1-sided test with the significance level of 0.025.|ANCOVA|||The null hypothesis was to assume that there was no difference between the pregabalin and placebo groups. The alternative was that the pregabalin group was superior to the placebo group.||-2.18|-10.20|0.0013
72497577|NCT01279057|144524944|SUPERIORITY|||||||0.0018|||||||ANCOVA|||||||0.0018
72497578|NCT01279057|144524944|SUPERIORITY|||||||0.0441|||||||ANCOVA|||||||0.0441
72497579|NCT01279057|144524945|EQUIVALENCE|90% confidence intervals within the interval 80.0% to 125.0%.|Ratio Test/Ref. LS Means|117.712|||||TWO_SIDED|90.0|95.41|146.583||||||||146.583|95.410|
72497580|NCT01279057|144524946|SUPERIORITY|||||||0.0018|||||||ANCOVA|||||||0.0018
72497581|NCT01279057|144524946|SUPERIORITY|||||||0.0451|||||||ANCOVA|||||||0.0451
72497582|NCT00531960|144524966|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.05||||0.806|TWO_SIDED|95.0|0.7|1.59|||Log Rank|||||1.59|0.70|0.8060
72497583|NCT00531960|144524968|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.24||||0.4063|TWO_SIDED|95.0|0.75|2.05|||Log Rank|||||2.05|0.75|0.4063
72497584|NCT00531960|144524969|SUPERIORITY_OR_OTHER||Difference in Response Rates|-17.28||||0.0444|TWO_SIDED|95.0|-34.8|0.3|||Chi-squared||The 95% CI for the difference of 2 rates was determined by using the Hauck-Anderson method.|||0.3|-34.8|0.0444
72497585|NCT00531960|144524970|SUPERIORITY_OR_OTHER||Difference in Disease Control Rates|-12.2||||0.0944|TWO_SIDED|95.0|-27.3|2.8|||Chi-squared||The 95% CI for the difference in disease control was determined using the Hauck-Anderson method.|||2.8|-27.3|0.0944
72497586|NCT00330187|144524998|SUPERIORITY||Odds Ratio (OR)|3.6||||0.07|TWO_SIDED|95.0|0.9|14.4|||Regression, Logistic|||||14.4|0.9|0.07
72497587|NCT00754156|144525043|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence analysis|||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||||||<0.01
72445312|NCT05481216|144405657|OTHER||Adjusted Hazard Ratio|1.3|||||TWO_SIDED|95.0|0.73|2.29||||||The adjusted variables were body mass index (BMI), dementia, peripheral vascular disease, history of pneumonia, connective tissue disease, liver disease, diabetes, chronic kidney disease, glucocorticoids, hydroxychloroquine, tocilizumab, and anti-IL6 inhibitors.||2.29|0.73|
72560700|NCT00860262|144651731|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.6|STANDARD_ERROR_OF_MEAN|1.18|<|0.0001|TWO_SIDED|95.0|-12.9|-8.3|||Repeated measures ANCOVA||Difference calculated as T80+A10 minus Telmisartan 80 mg|||-8.3|-12.9|<0.0001
72560701|NCT00860262|144651731|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.4|STANDARD_ERROR_OF_MEAN|1.18||0.0002|TWO_SIDED|95.0|-6.7|-2.1|||Repeated measures ANCOVA||Difference calculated as T80+A10 minus amlodipine 10 mg|||-2.1|-6.7|0.0002
72560702|NCT00860262|144651732|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.6|STANDARD_ERROR_OF_MEAN|1.25|<|0.0001|TWO_SIDED|95.0|-13.1|-8.2|||Repeated measures ANCOVA||Difference calculated as T80+A10 minus telmisartan 80 mg|||-8.2|-13.1|<0.0001
72560703|NCT00860262|144651732|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.8|STANDARD_ERROR_OF_MEAN|1.24||0.0001|TWO_SIDED|95.0|-7.3|-2.4|||Repeated measures ANCOVA||Difference calculated as T80+A10 minus amlodipine 10 mg|||-2.4|-7.3|0.0001
72560704|NCT00860262|144651733|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.2|STANDARD_ERROR_OF_MEAN|1.24|<|0.0001|TWO_SIDED|95.0|-12.6|-7.7|||Repeated measures ANCOVA||Difference calculated as T80+A10 minus telmisartan 80 mg|||-7.7|-12.6|<0.0001
72560705|NCT00860262|144651733|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.8|STANDARD_ERROR_OF_MEAN|1.24||0.0001|TWO_SIDED|95.0|-7.2|-2.4|||Repeated measures ANCOVA||Difference calculated as T80+A10 minus amlodipine 10 mg|||-2.4|-7.2|0.0001
72560706|NCT00860262|144651734|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.8|STANDARD_ERROR_OF_MEAN|1.2|<|0.0001|TWO_SIDED|95.0|-10.2|-5.4|||Repeated measures ANCOVA||Difference calculated as T80+A10 minus telmisartan 80 mg|||-5.4|-10.2|<0.0001
72560707|NCT00860262|144651734|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.6|STANDARD_ERROR_OF_MEAN|1.21||0.0001|TWO_SIDED|95.0|-7.0|-2.3|||Repeated measures ANCOVA||Difference calculated as T80+A10 minus amlodipine 10 mg|||-2.3|-7.0|0.0001
72560708|NCT00860262|144651735|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.4|STANDARD_ERROR_OF_MEAN|1.23|<|0.0001|TWO_SIDED|95.0|-8.8|-4.0|||Repeated measures ANCOVA||Difference calculated as T80+A10 minus telmisartan 80 mg|||-4.0|-8.8|<0.0001
72560709|NCT00860262|144651735|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.3|STANDARD_ERROR_OF_MEAN|1.23||0.0077|TWO_SIDED|95.0|-5.7|-0.9|||Repeated measures ANCOVA||Difference calculated as T80+A10 minus amlodipine 10 mg|||-0.9|-5.7|0.0077
72560710|NCT05194202|144651785|OTHER|||||||0.622|||||||one-sample test of proportions|Hypothesis was evaluated using a one-tailed, one-proportion z-test.||Our null hypothesis for the acceptability was P0 great than or equal to 85% vs. the alternative P0 less than 85%. Acceptability responses were dichotomized to include neutral with strongly disagree/disagree.||||.622
72560711|NCT05194202|144651786|OTHER|||||||0.038|||||||one sample test of proportions|Hypothesis was evaluated using a one-tailed, one-proportion z-test||Our null hypothesis for the acceptabnility of the ED-Heart was P0 great than or equal to 85% vs. the alternative P0 less than 85%. Acceptability responses were dichotomized to include neutral with strongly disagree/disagree.||||.038
72560712|NCT02005562|144651797|SUPERIORITY_OR_OTHER|||||||0.479|||||||Chi-squared|||||||0.479
72560713|NCT02005562|144651798|SUPERIORITY_OR_OTHER|||||||0.6736|||||||ANOVA|||||||0.6736
72560714|NCT02005562|144651799|SUPERIORITY_OR_OTHER|||||||0.2172|||||||ANOVA|||||||0.2172
72560715|NCT02005562|144651800|SUPERIORITY_OR_OTHER|||||||0.477|||||||ANOVA|||||||0.4770
72560716|NCT02005562|144651802|SUPERIORITY_OR_OTHER|||||||0.0764|||||||Log Rank|||||||0.0764
72560717|NCT02005562|144651803|SUPERIORITY_OR_OTHER|||||||0.418|||||||Fisher Exact|||Week 12||||0.418
72445313|NCT05481216|144405661|OTHER|||||||0.009|||||||Regression, Logistic|||Conditional logistic regression models accounting for case-control matching will be used to identify risk factors for advanced immunodeficiency associated with COVID-19.||||0.009
72560718|NCT02005562|144651803|SUPERIORITY_OR_OTHER|||||||0.841|||||||Fisher Exact|||Week 52||||0.841
72560719|NCT02005562|144651804|SUPERIORITY_OR_OTHER|||||||0.245|||||||Fisher Exact|||Week 12||||0.245
72560720|NCT02005562|144651804|SUPERIORITY_OR_OTHER|||||||0.637|||||||Fisher Exact|||Week 52||||0.637
72560721|NCT02005562|144651805|SUPERIORITY_OR_OTHER|||||||0.512||||||Mycophenolate Mofetil, Adapted Dose vs. Mycophenolate Mofetil, Fixed Dose at protocol biopsy at Week 12.|Fisher Exact|||||||0.512
72560722|NCT02005562|144651805|SUPERIORITY_OR_OTHER|||||||0.718||||||Mycophenolate Mofetil, Adapted Dose vs. Mycophenolate Mofetil, Fixed Dose at protocol biopsy at Week 52.|Fisher Exact|||||||0.718
72560723|NCT02005562|144651807|SUPERIORITY_OR_OTHER|||||||0.86|||||||Log Rank|||||||0.860
72560724|NCT04729101|144651809|OTHER|Additional statistics were descriptive in nature.|Least-squares mean difference|38.98|||||TWO_SIDED|95.0|31.94|46.02||||||Vonoprazan versus lansoprazole on Day 1 of each treatment period.||46.02|31.94|
72560725|NCT04729101|144651809|OTHER|Additional statistics were descriptive in nature|Least-squares mean difference|44.62|||||TWO_SIDED|95.0|37.55|51.69||||||Vonoprazan versus lansoprazole on Day 7 of each treatment period.||51.69|37.55|
72560726|NCT04729101|144651810|OTHER|Additional statistics were descriptive in nature.|Least-squares mean difference|1.72|||||TWO_SIDED|95.0|1.4|2.04||||||Vonoprazan versus lansoprazole on Day 1 of each treatment period.||2.04|1.40|
72560727|NCT04729101|144651810|OTHER|Additional statistics were descriptive in nature.|Least-squares mean difference|2.09|||||TWO_SIDED|95.0|1.74|2.44||||||Vonoprazan versus lansoprazole on Day 7 of each treatment period.||2.44|1.74|
72560728|NCT00274625|144651818|SUPERIORITY_OR_OTHER|||||||0.6|TWO_SIDED||||||Fisher Exact|||||||0.60
72560729|NCT02940522|144651819|OTHER|Comparison of bioavailability|||||||||||||||||The PK parameters were compared between treatments using an analysis of variance statistical model with treatment as the fixed effect, using the natural logarithms of the data. As the objective was to assess whether comparable exposure could be obtained using the higher SQ dose, the data were not normalized for dose before the statistical analysis.|||
72445314|NCT05481216|144405682|OTHER||Odds Ratio (OR)|0.85||||0.033|TWO_SIDED|95.0|0.74|0.99|||Regression, Logistic|||Conditional logistic regression models accounting for case-control matching will be used to identify risk factors for advanced immunodeficiency associated with COVID-19. Odds ratio (OR), and the 95% confidence intervals of the OR will be calculated||0.99|0.74|0.033
72560730|NCT02940522|144651820|OTHER|Comparison of bioavailability data|||||||||||||||||The PK parameters were compared between treatments using an analysis of variance statistical model with treatment as the fixed effect, using the natural logarithms of the data. As the objective was to assess whether comparable exposure could be obtained using the higher SQ dose, the data were not normalized for dose before the statistical analysis.|||
72389685|NCT00679432|144287204|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportions|4.7||||0.22|TWO_SIDED|95.0|-2.7|12.1|||Chi-squared||See comments from the budesonide 6 mg versus placebo comparison (statistical analysis 1).|See comments from the budesonide 6 mg versus placebo comparison (statistical analysis 1).||12.1|-2.7|0.2200
72560731|NCT02940522|144651821|OTHER|Comparison of bioavailability data|||||||||||||||||The PK parameters were compared between treatments using an analysis of variance statistical model with treatment as the fixed effect, using the natural logarithms of the data. As the objective was to assess whether comparable exposure could be obtained using the higher SQ dose, the data were not normalized for dose before the statistical analysis.|||
72389686|NCT00679432|144287205|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportions|5.8||||0.3146|TWO_SIDED|95.0|-5.5|17.0|||Chi-squared||The difference in proportions was determined by subtracting the proportion of patients who reached the endpoint in the placebo group from that proportion in the active group (active minus placebo).|Clinical improvement and endoscopic improvement were analyzed hierarchically. If at least one primary endpoint comparison was statistically significant, clinical improvement was to be compared between each budesonide MMX group and placebo at the α = 0.025 level of significance. If at least one comparison of clinical improvement was statistically significant, endoscopic improvement was to be compared between each budesonide MMX dose group and placebo at the α = 0.025 level of significance.||17.0|-5.5|0.3146
72389687|NCT00679432|144287205|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportions|8.5||||0.142|TWO_SIDED|95.0|-2.8|19.9|||Chi-squared||See comments from the budesonide 6 mg versus placebo comparison (statistical analysis 1).|See comments from the budesonide 6 mg versus placebo comparison (statistical analysis 1).||19.9|-2.8|0.1420
72389688|NCT00679432|144287205|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportions|9.1||||0.1189|TWO_SIDED|95.0|-2.3|20.4|||Chi-squared||See comments from the budesonide 6 mg versus placebo comparison (statistical analysis 1).|See comments from the budesonide 6 mg versus placebo comparison (statistical analysis 1).||20.4|-2.3|0.1189
72389689|NCT00679432|144287206|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportions|0.0||||0.9991|TWO_SIDED|95.0|-11.8|11.8|||Chi-squared||The difference in proportions was determined by subtracting the proportion of patients who reached the endpoint in the placebo group from that proportion in the active group (active minus placebo).|As per the hierarchical testing procedure for secondary endpoints, because clinical improvement was not statistically significant in the ITT population, formal statistical comparisons for endoscopic improvement between the 2 budesonide MMX groups and placebo were not conducted. The statistical comparison between the Asacol and placebo groups is shown here.||11.8|-11.8|0.9991
72389690|NCT05544734|144287238|SUPERIORITY||Median Difference (Final Values)|-0.3||||0.69|TWO_SIDED|95.0|-1.85|1.25|||t-test, 2 sided||Direction = Hydrocodone group mean change (i.e., change = baseline to postoperative day 2) minus Non-Hydrocodone group mean change (i.e., change = baseline to postoperative day 2).|||1.25|-1.85|0.69
72389691|NCT05544734|144287239|SUPERIORITY||Median Difference (Final Values)|2.3||||0.62|TWO_SIDED|95.0|-7.25|11.85|||t-test, 2 sided||Direction = Hydrocodone group mean change (i.e., change = postoperative day 3 to postoperative day 6) minus Non-Hydrocodone group mean change (i.e., change = postoperative day 3 to postoperative day 6).|||11.85|-7.25|0.62
72389692|NCT00873912|144287251|NON_INFERIORITY_OR_EQUIVALENCE|Based on similar fever rate with 300 evaluable subjects (240 vaccine and 60 placebo recipients), the study would provide at least 98% power to rule out a rate increase of 5 percentage points assuming the true difference between the treatment groups is zero and the true fever rate is ≤ 1.0%. Power would be lower if the true difference was different from zero.|rate difference|-1.3|||||TWO_SIDED|95.0|-7.9|1.3|||score statistic|||The percentage of subjects with fever was compared between the two treatment groups based on the upper limit of the two-sided 95% CIs for rate difference (monovalent vaccine minus placebo). The upper limit of the two-sided 95% CI was evaluated against the pre-specified equivalence criterion of 5 percentage points which corresponded to the following hypotheses: - H0 (null): rate difference ≥ 5 percentage points, - HA (alternative): rate difference \< 5 percentage points.||1.3|-7.9|
72389693|NCT05263895|144287285|OTHER||Ratio of Adjusted Geometric means|90.54|||||TWO_SIDED|90.0|79.85|102.65||||||Test: Nirmatrelvir (slower dissolution tablets)/ritonavir 300/100 mg Reference: Nirmatrelvir (commercial tablets)/ritonavir 300/100 mg||102.65|79.85|
72389694|NCT05263895|144287285|OTHER||Ratio of Adjusted Geometric Means|102.78|||||TWO_SIDED|90.0|90.65|116.53||||||Test: Nirmatrelvir (large particle size tablets)/ritonavir 300/100 mg Reference: Nirmatrelvir (commercial tablets)/ritonavir 300/100 mg||116.53|90.65|
72389695|NCT05263895|144287285|OTHER||Ratio of Adjusted Geometric Means|138.15|||||TWO_SIDED|90.0|118.03|161.69||||||Test: Nirmatrelvir (SDD suspension)/ritonavir 300/100 mg Reference: Nirmatrelvir (commercial tablets)/ritonavir 300/100 mg||161.69|118.03|
72389696|NCT05263895|144287285|OTHER||Ratio of Adjusted Geometric Means|30.8|||||TWO_SIDED|90.0|25.7|35.2||||||Test: Nirmatrelvir (SDD suspension) 300 mg Reference: Nirmatrelvir (commercial tablets)/ritonavir 300/100 mg||35.20|25.70|
72389697|NCT05263895|144287286|OTHER||Ratio of Adjusted Geometric Means|91.26|||||TWO_SIDED|90.0|80.46|103.51||||||Test: Nirmatrelvir (slower dissolution tablets)/ritonavir 300/100 mg Reference: Nirmatrelvir (commercial tablets)/ritonavir 300/100 mg||103.51|80.46|
72389698|NCT05263895|144287286|OTHER||Ratio of Adjusted Geometric Means|102.49|||||TWO_SIDED|90.0|90.36|116.26||||||Test: Nirmatrelvir (large particle size tablets)/ritonavir 300/100 mg Reference: Nirmatrelvir (commercial tablets)/ritonavir 300/100 mg||116.26|90.36|
72389699|NCT05263895|144287286|OTHER||Ratio of Adjusted Geometric Means|136.99|||||TWO_SIDED|90.0|117.09|160.27||||||Test: Nirmatrelvir (SDD suspension)/ritonavir 300/100 mg Reference: Nirmatrelvir (commercial tablets)/ritonavir 300/100 mg||160.27|117.09|
72389700|NCT05263895|144287286|OTHER||Ratio of Adjusted Geometric Means|29.77|||||TWO_SIDED|90.0|25.45|34.83||||||Test: Nirmatrelvir (SDD suspension) 300 mg Reference: Nirmatrelvir (commercial tablets)/ritonavir 300/100 mg||34.83|25.45|
72389701|NCT05263895|144287287|OTHER||Ratio of Adjusted Geometric Means|94.28|||||TWO_SIDED|90.0|80.77|110.05||||||Test: Nirmatrelvir (slower dissolution tablets)/ritonavir 300/100 mg Reference: Nirmatrelvir (commercial tablets)/ritonavir 300/100 mg||110.05|80.77|
72497588|NCT01751971|144525048|SUPERIORITY||Mean Difference (Net)|10.5||||0.4|TWO_SIDED|95.0|-16.0|37.1|||t-test, 2 sided||Positive estimated value would represent a greater reduction in AHI with oxygen (% sham) in the high vs low loop gain group.|"Primary statistical comparison was the percent reduction in AHI----\[AHI(sham)-AHI(oxygen)\]/AHI(sham) %----between two phenotypic patient subgroups. Patient subgroups were defined by the loop gain (LG1) measured on the sham night as high or low (a priori cutoff LG1=0.7)."||37.1|-16|0.4
72497589|NCT01751971|144525048|SUPERIORITY||Mean Difference (Final Values)|17.4|STANDARD_ERROR_OF_MEAN|3.3|<|0.001|TWO_SIDED|95.0|10.7|24.1|||t-test, 2 sided||Direction of comparison: Positive estimation parameter would indicate lower AHI on oxygen versus sham.|Here we aimed to confirm that there was a difference between AHI on oxygen vs sham (overall, i.e. in unselected patients). This test, however was not part of our primary objective.||24.1|10.7|<0.001
72389702|NCT05263895|144287287|OTHER||Ratio of Adjusted Geometric Means|108.6|||||TWO_SIDED|90.0|93.04|126.76||||||Test: Nirmatrelvir (large particle size tablets)/ritonavir 300/100 mg Reference: Nirmatrelvir (commercial tablets)/ritonavir 300/100 mg||126.76|93.04|
72560732|NCT02940522|144651822|OTHER|Comparison of bioavailability data|||||||||||||||||The PK parameters were compared between treatments using an analysis of variance statistical model with treatment as the fixed effect, using the natural logarithms of the data. As the objective was to assess whether comparable exposure could be obtained using the higher SQ dose, the data were not normalized for dose before the statistical analysis.|||
72560733|NCT02940522|144651823|OTHER|Comparison of bioavailability data|||||||||||||||||The PK parameters were compared between treatments using an analysis of variance statistical model with treatment as the fixed effect, using the natural logarithms of the data. As the objective was to assess whether comparable exposure could be obtained using the higher SQ dose, the data were not normalized for dose before the statistical analysis.|||
72389703|NCT05263895|144287287|OTHER||Ratio of Adjusted Geometric Means|264.12|||||TWO_SIDED|90.0|232.32|300.27||||||Test: Nirmatrelvir (SDD suspension)/ritonavir 300/100 mg Reference: Nirmatrelvir (commercial tablets)/ritonavir 300/100 mg||300.27|232.32|
72389704|NCT05263895|144287287|OTHER||Ratio of Adjusted Geometric Means|145.53|||||TWO_SIDED|90.0|128.01|165.45||||||Test: Nirmatrelvir (SDD suspension) 300 mg Reference: Nirmatrelvir (commercial tablets)/ritonavir 300/100 mg||165.45|128.01|
72389705|NCT01218113|144287302|NON_INFERIORITY|Crierion for non-inferiority evaluation: The upper limit (UL) of the two-sided 97.5% confidence interval (CI) for the difference in change between the two arms (3D\_HIV Group - Control Group) is below 0.|Geometric Mean Ratio|0.801|||||TWO_SIDED|97.5|0.553|1.162|||Repeated-measures mixed model|||To show the difference in change from baseline of HIV-1 VL at week 48 between persons who received 3 doses of the HIV vaccine 732462 and persons who received placebo alone.||1.162|0.553|
72389706|NCT01218113|144287302|NON_INFERIORITY|Crierion for non-inferiority evaluation: The upper limit (UL) of the two-sided 97.5% confidence interval (CI) for the difference in change between the two arms (2D\_HIV Group - Control Group) is below 0.|Geometric Mean Ratio|1.184|||||TWO_SIDED|97.5|0.816|1.717|||Repeated-measures mixed model|||To show the difference in change from baseline of HIV-1 VL at week 48 between persons who received 2 doses of the HIV Vaccine 732462 and persons who received placebo alone.||1.717|0.816|
72389707|NCT01218113|144287303|NON_INFERIORITY|Criterion for non-inferiority evaluation: The upper limit (UL) of the two-sided 97.5% confidence interval (CI) for the difference in change between the two arms (3D\_HIV Group - Control Group) is below 0.|Mean Difference|-0.096|||||TWO_SIDED|97.5|-0.257|0.065|||Repeated-measures mixed model|||To show the difference in change from baseline of HIV-1 VL (log10-transformed values) at week 48 between persons who received 3 doses of the HIV Vaccine 732462 and persons who received placebo alone.||0.065|-0.257|
72389708|NCT01218113|144287303|NON_INFERIORITY|Criterion for non-inferiority evaluation: The upper limit (UL) of the two-sided 97.5% confidence interval (CI) for the difference in change between the two arms (2D\_HIV Group - Control Group) is below 0.|Mean Difference|0.073|||||TWO_SIDED|97.5|-0.088|0.235|||Repeated-measures mixed model|||To show the difference in change from baseline of HIV-1 VL (log10-transformed values) at week 48 between persons who received 2 doses of the HIV Vaccine 732462 and persons who received placebo alone.||0.235|-0.088|
72389709|NCT00967668|144287368|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Regression, Linear|Linear mixed-effects model with baseline, 3- and 12-month outcome values modeled as dependent variables||All participants were included in outcomes analyses using intention-to-treat principles. A linear mixed-effects model with baseline, 3- and 12-month outcome values modeled as dependent variables was used.This statistical approach allows the use of data from all participants as long as the dependent variable is available for at least one time point. Each subject was included as a random intercept to adjust for within-person correlations.||||<0.05
72389710|NCT01637935|144287377|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.1||||||95.0|0.92|1.31||||||Fully adjusted refers to inclusion of all potential confounders in the statistical model from the 5-year interim report plus year of cohort entry: age, sex, race/ethnicity, other diabetes medications, smoking, other bladder conditions, median household income, congestive heart failure, cancer other than bladder cancer, renal insufficiency, HbA1c and the interaction with new diagnosis of diabetes, duration of diabetes, and year of cohort entry.||1.31|0.92|
72389711|NCT01637935|144287377|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.06||||||95.0|0.89|1.26||||||Fully adjusted adding the proteinuria testing variable.||1.26|0.89|
72389712|NCT01637935|144287378|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.89||||||95.0|0.71|1.12||||||Time since starting pioglitazone \<4.5 years vs unexposed group. Fully adjusted including all potential confounders in statistical model from 5-year interim report plus year of cohort entry: age, sex, race/ethnicity, other diabetes medications, smoking, other bladder conditions, median household income, congestive heart failure, cancer other than bladder, renal insufficiency, HbA1c and interaction with new diagnosis of diabetes, duration of diabetes, year of cohort entry and proteinuria.||1.12|0.71|
72389713|NCT01637935|144287378|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.21||||||95.0|0.93|1.59||||||Time since starting pioglitazone 4.5-8 years vs unexposed group. Fully adjusted including all potential confounders in statistical model from 5-year interim report plus year of cohort entry: age, sex, race/ethnicity, other diabetes medications, smoking, other bladder conditions, median household income, congestive heart failure, cancer other than bladder, renal insufficiency, HbA1c and interaction with new diagnosis of diabetes, duration of diabetes, year of cohort entry and proteinuria.||1.59|0.93|
72497590|NCT01751971|144525048|SUPERIORITY||Mean Difference (Net)|42.8||||0.001|TWO_SIDED|95.0|21.0|64.6|||t-test, 2 sided||Direction of comparison: Positive estimated value would indicate a greater percentage reduction in AHI (oxygen vs. sham) in favorable vs. unfavorable subgroups.|"The primary goal of the study was to identify a phenotypic subgroup of patients with sleep apnea that responds preferentially to oxygen (percent reduction in AHI----\[AHI(sham)-AHI(oxygen)\]/AHI(sham) %). We defined patient subgroups (favorable versus unfavorable) based on the four key phenotypic traits (loop gain, collapsibility, arousal threshold, muscle responses) measured on the sham night, with the use of multiple logistic regression and leave-one-out cross validation."||64.6|21.0|0.001
72445315|NCT05481216|144405683|OTHER||Odds Ratio (OR)|1.93||||0.012|TWO_SIDED|95.0|1.16|3.22|||Regression, Logistic|||Conditional logistic regression models accounting for case-control matching will be used to identify risk factors for advanced immunodeficiency associated with COVID-19. Odds ratio (OR), and the 95% confidence intervals of the OR will be calculated||3.22|1.16|0.012
72445316|NCT05481216|144405684|OTHER||Odds Ratio (OR)|0.99||||0.458|TWO_SIDED|95.0|0.95|1.02|||Regression, Logistic|||Conditional logistic regression models accounting for case-control matching will be used to identify risk factors for advanced immunodeficiency associated with COVID-19. Odds ratio (OR), and the 95% confidence intervals of the OR will be calculated||1.02|0.95|0.458
72445317|NCT05481216|144405685|OTHER||Odds Ratio (OR)|2.71|||<|0.001|TWO_SIDED|95.0|1.61|4.57|||Regression, Logistic|||Conditional logistic regression models accounting for case-control matching will be used to identify risk factors for advanced immunodeficiency associated with COVID-19. Odds ratio (OR), and the 95% confidence intervals of the OR will be calculated||4.57|1.61|<0.001
72445318|NCT05481216|144405686|OTHER||Odds Ratio (OR)|1.74|||<|0.001|TWO_SIDED|95.0|1.34|2.25|||Regression, Logistic|||Conditional logistic regression models accounting for case-control matching will be used to identify risk factors for advanced immunodeficiency associated with COVID-19. Odds ratio (OR), and the 95% confidence intervals of the OR will be calculated||2.25|1.34|<0.001
72445319|NCT04005716|144405687|SUPERIORITY||Hazard Ratio (HR)|0.75||||0.004|TWO_SIDED|95.0|0.61|0.93|||Log Rank|Stratified log rank test with ECOG performance status, and investigator chosen platinum as stratification factors.|The hazard ratio was estimated using a stratified Cox regression model with Efron's method for ties, stratified by ECOG performance status and investigator-selected platinum agents, with Arm B as the reference group.|The null hypothesis stated that the overall survival in Arm A (Tislelizumab + Chemotherapy) is less than or equal to that in Arm B (the placebo group), while the alternative hypothesis posits that the overall survival in Arm A is greater than that in Arm B.||0.93|0.61|0.0040
72445320|NCT04005716|144405688|SUPERIORITY||Hazard Ratio (HR)|0.64|||<|0.0001|TWO_SIDED|95.0|0.52|0.78|||Log Rank|One-sided log-rank test p-value, stratified by ECOG performance status (1 vs 0) and type of platinum therapy (carboplatin vs cisplatin).|The hazard ratio was estimated using a stratified Cox regression model with Efron's method for ties, stratified by ECOG performance status and investigator-selected platinum agents, with Arm B as the reference group.|||0.78|0.52|<0.0001
72445321|NCT04005716|144405689|OTHER||Odds Ratio (OR)|1.33|||||TWO_SIDED|95.0|0.9|1.96|||||Odds ratio was calculated using Cochran-Mantel-Haenszel estimates and stratified by ECOG performance (1 vs 0) and platinum (Carboplatin vs Cisplatin)|||1.96|0.90|
72445322|NCT04005716|144405696|OTHER||Hazard Ratio (HR)|0.92|||||TWO_SIDED|95.0|0.642|1.33|||||Hazard ratio was based on unstratified Cox regression model including treatment as covariate.|Analyses of Time to Deterioration of EORTC QLQ-C30 Physical Functioning Score||1.330|0.642|
72445323|NCT04005716|144405696|OTHER||Hazard Ratio (HR)|0.73|||||TWO_SIDED|95.0|0.473|1.123|||||Hazard ratio was based on unstratified Cox regression model including treatment as covariate.|Analyses of Time to Deterioration of EORTC QLQ-LC13 Coughing Score||1.123|0.473|
72445324|NCT04005716|144405696|OTHER||Hazard Ratio (HR)|0.72|||||TWO_SIDED|95.0|0.485|1.057|||||Hazard ratio was based on unstratified Cox regression model including treatment as covariate.|Analyses of Time to Deterioration of EORTC QLQ-LC13 Chest Pain Score||1.057|0.485|
72445325|NCT02226276|144405711|OTHER||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
72445326|NCT02226276|144405712|OTHER||||||<|0.01|||||||t-test, 2 sided|||||||<0.01
72445327|NCT05592418|144405769|SUPERIORITY||Mean Difference (Final Values)|0.0288||||0.9851|TWO_SIDED|95.0|-3.0397|3.0972|||ANCOVA||LS Mean difference = LS Mean of Ampligen® - LS Mean of Placebo|||3.0972|-3.0397|0.9851
72445328|NCT05592418|144405770|SUPERIORITY||Mean Difference (Final Values)|-1.9076||||0.3095|TWO_SIDED|95.0|-5.6279|1.8128|||ANCOVA|||||1.8128|-5.6279|0.3095
72445329|NCT05592418|144405771|SUPERIORITY||Mean Difference (Final Values)|0.6086||||0.7663|TWO_SIDED|95.0|-3.4656|4.6829|||ANCOVA||LS Mean difference = LS Mean of Ampligen® - LS Mean of Placebo|||4.6829|-3.4656|0.7663
72445330|NCT05592418|144405772|SUPERIORITY||Mean Difference (Final Values)|23.7749||||0.3162|TWO_SIDED|95.0|-23.2463|70.7962|||ANCOVA||LS Mean difference = LS Mean of Ampligen® - LS Mean of Placebo|||70.7962|-23.2463|0.3162
72445331|NCT05592418|144405773|SUPERIORITY|||||||||||||||||P-value is from The Cochran-Mantel-Haenszel test (CMH) stratified by stratification factors|Since all patients analyzed achieved MCID, there are no comparison results|||
72445332|NCT05592418|144405774|SUPERIORITY||Mean Difference (Final Values)|-3.2342||||0.4232|TWO_SIDED|95.0|-11.2586|4.7901|||ANCOVA||LS Mean difference = LS Mean of Ampligen® - LS Mean of Placebo|||4.7901|-11.2586|0.4232
72445333|NCT05592418|144405775|SUPERIORITY||Mean Difference (Final Values)|-0.5161||||0.7823|TWO_SIDED|95.0|-4.2356|3.2035|||ANCOVA||LS Mean difference = LS Mean of Ampligen® - LS Mean of Placebo|||3.2035|-4.2356|0.7823
72445334|NCT05592418|144405777|SUPERIORITY||Mean Difference (Final Values)|0.2779||||0.5185|TWO_SIDED|95.0|-0.5775|1.1333|||ANCOVA||LS Mean difference = LS Mean of Ampligen® - LS Mean of Placebo.|||1.1333|-0.5775|0.5185
72445335|NCT05592418|144405778|OTHER||||||||||||||||||No patients were hospitalized.|||
72445336|NCT05592418|144405780|SUPERIORITY||Mean Difference (Final Values)|169.389||||0.2175|TWO_SIDED|95.0|-105.892|444.6702|||ANCOVA||LS Mean difference = LS Mean of Ampligen® - LS Mean of Placebo||LS Mean difference = LS Mean of Ampligen® - LS Mean of Placebo.|444.6702|-105.892|0.2175
72445337|NCT05592418|144405781|SUPERIORITY||Mean Difference (Final Values)|-56.9984||||0.2086|TWO_SIDED|95.0|-147.021|33.0241|||ANCOVA||LS Mean difference = LS Mean of Ampligen® - LS Mean of Placebo||LS Mean difference = LS Mean of Ampligen® - LS Mean of Placebo|33.0241|-147.021|0.2086
72445338|NCT05592418|144405782|SUPERIORITY||Mean Difference (Final Values)|0.1733||||0.0975|TWO_SIDED|95.0|-0.0327|0.3792|||ANCOVA||LS Mean difference = LS Mean of Ampligen® - LS Mean of Placebo||LS Mean difference = LS Mean of Ampligen® - LS Mean of Placebo|0.3792|-0.0327|0.0975
72445339|NCT05592418|144405784|SUPERIORITY||Mean Difference (Final Values)|20.7131||||0.4545|TWO_SIDED|95.0|-34.4079|75.8341|||ANCOVA||LS Mean Difference - LS Mean of Ampligen® - LS Mean of Placebo|||75.8341|-34.4079|0.4545
72445340|NCT05592418|144405785|SUPERIORITY||Mean Difference (Final Values)|44.1231||||0.0333|TWO_SIDED|95.0|4.6338|83.6123|||ANCOVA||LS Mean Difference - LS Mean of Ampligen® - LS Mean of Placebo|||83.6123|4.6338|0.0333
72445341|NCT01781468|144405799|SUPERIORITY|||||||0.9601|||||||Fisher Exact|||||||0.9601
72445342|NCT01781468|144405800|SUPERIORITY|||||||0.7877|||||||Fisher Exact|||||||0.7877
72445343|NCT01781468|144405801|SUPERIORITY|||||||0.3272|||||||Kruskal-Wallis|||||||0.3272
72445344|NCT01781468|144405802|SUPERIORITY|||||||0.9122|||||||Kruskal-Wallis|||Baseline to Week 4||||0.9122
72497591|NCT01649947|144525066|OTHER||Mean Difference (Net)|56.0||||0.01|TWO_SIDED|95.0|8.9|72.0|||t-test, 2 sided|||The analysis is comprised of evaluable patients who had measureable disease and received at least one cycle of therapy and had disease evaluated.||72|8.9|0.01
72560734|NCT02940522|144651824|OTHER|Comparison of bioavailability data|||||||||||||||||The PK parameters were compared between treatments using an analysis of variance statistical model with treatment as the fixed effect, using the natural logarithms of the data. As the objective was to assess whether comparable exposure could be obtained using the higher SQ dose, the data were not normalized for dose before the statistical analysis.|||
72560735|NCT02959840|144651825|EQUIVALENCE|Our null hypothesis is that there is no statistically significant difference between the number of people who experienced nausea in the above 2 groups.|||||<|1e-05|||||||Chi-squared|||||||< 0.00001
72560736|NCT02959840|144651825|EQUIVALENCE|Our null hypothesis is that there is no statistically significant difference between the number of people who experienced nausea in the above 2 groups.||||||5e-05|||||||Chi-squared|||||||0.00005
72445345|NCT01781468|144405802|SUPERIORITY|||||||0.8559|||||||Kruskal-Wallis|||Baseline to Week 8||||0.8559
72445346|NCT04150718|144405871|OTHER||||||<|0.05||||||a priori threshold for statistical significance set at \<0.05|ANOVA|Repeated measures ANOVA, main effect of time, F(1,35) =4.73||||||<0.05
72445347|NCT04150718|144405872|OTHER||||||<|0.05||||||a priori threshold for statistical significance set at p\<0.05.|ANOVA|Repeated Measures ANOVA, main effect of time, F(1,39) = 4.20||||||<0.05
72445348|NCT04150718|144405873|OTHER||||||<|0.001||||||a priori threshold for statistical significance set at p \<0.05|ANOVA|Repeated measures ANOVA interaction, F(1,48) = 61.849||||||<0.001
72445349|NCT05493787|144405900|SUPERIORITY|||||||0.003||||||Comparisons between Passive Control and all other arms (Analyses 1-5) were analyzed in the same regression. The p-value reported is 2-tailed.|Regression, Linear|||Null hypothesis: Flu shot self-scheduling does not differ between those sent an Active Control message and those not sent a message (i.e., those in the Passive Control group); Alternative hypothesis: Sending an Active Control message increases self-scheduling compared with sending no message. Analysis combines across November and December send dates.||||.003
72445350|NCT05493787|144405900|SUPERIORITY||||||<|0.001||||||Comparisons between Passive Control and all other arms (Analyses 1-5) were analyzed in the same regression. The p-value reported is 2-tailed.|Regression, Linear|||Null hypothesis: Flu shot self-scheduling does not differ between those sent an Ease message and those not sent a message (i.e., those in the Passive Control group); Alternative hypothesis: Sending an Ease message increases self-scheduling compared with sending no message. Analysis combines across November and December send dates.||||<.001
72445351|NCT05493787|144405900|SUPERIORITY||||||<|0.001||||||Comparisons between Passive Control and all other arms (Analyses 1-5) were analyzed in the same regression.|Regression, Linear|||Null hypothesis: Flu shot self-scheduling does not differ between those sent an Waiting for You message message and those not sent a message (i.e., those in the Passive Control group); Alternative hypothesis: Sending a Waiting for You message increases self-scheduling compared with sending no message. Analysis combines across November and December send dates.||||<.001
72445352|NCT05493787|144405900|SUPERIORITY|||||||0.003||||||Comparisons between Passive Control and all other arms (Analyses 1-5) were analyzed in the same regression. The p-value reported is 2-tailed.|Regression, Linear|||Null hypothesis: Flu shot self-scheduling does not differ between those sent a Protect Yourself - Rare message and those not sent a message (i.e., those in the Passive Control group); Alternative hypothesis: Sending a Protect Yourself - Rare Message increases self-scheduling compared with sending no message. Analysis combines across November and December send dates.||||.003
72445353|NCT05493787|144405900|SUPERIORITY|||||||0.035||||||Comparisons between Passive Control and all other arms (Analyses 1-5) were analyzed in the same regression. The p-value reported is 2-tailed.|Regression, Linear|||Null hypothesis: Flu shot self-scheduling does not differ between those sent a Protect Yourself - Frequent message and those not sent a message (i.e., those in the Passive Control group); Alternative hypothesis: Sending a Protect Yourself - Frequent message increases self-scheduling compared with sending no message. Analysis combines across November and December send dates.||||.035
72445354|NCT05493787|144405900|SUPERIORITY|||||||0.593||||||Comparisons between Active Control and all other arms (Analyses 6-9) were analyzed in the same regression. The p-value reported is 2-tailed.|Regression, Linear|||Null hypothesis: Active Control messages and Ease messages are equally effective at promoting flu shot self-scheduling; Alternative hypothesis: Ease messages are more effective at promoting flu shot self-scheduling than Active Control messages. Analysis combines across November and December send dates.||||.593
72445355|NCT05493787|144405900|SUPERIORITY|||||||0.052||||||Comparisons between Active Control and all other arms (Analyses 6-9) were analyzed in the same regression. The p-value reported is 2-tailed.|Regression, Linear|||Null hypothesis: Active Control messages and Waiting for You messages are equally effective at promoting flu shot self-scheduling; Alternative hypothesis: Waiting for You messages are more effective at promoting flu shot self-scheduling than Active Control messages. Analysis combines across November and December send dates.||||.052
72497592|NCT00364182|144525068|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-30.5|||<|0.0001|TWO_SIDED|95.0|-36.5|-24.5||P-values based on a model including terms for treatment regimen, treatment sequence, and the interaction of these terms with repeated measures on participants.|ANOVA|||||-24.5|-36.5|<0.0001
72560737|NCT02959840|144651825|EQUIVALENCE|Our null hypothesis is that there is no statistically significant difference between the number of people who experienced nausea in the above 2 groups.||||||0.1|||||||Chi-squared|||||||0.1
72560738|NCT02959840|144651826|EQUIVALENCE|Our null hypothesis is that there is no statistically significant difference between the number of people who experienced vomiting in the above 2 groups.||||||0.001|||||||Chi-squared|||||||0.001
72497593|NCT00364182|144525068|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-32.5|||<|0.0001|TWO_SIDED|95.0|-38.5|-26.6||P-values based on a model including terms for treatment regimen, treatment sequence, and the interaction of these terms with repeated measures on participants.|ANOVA|||||-26.6|-38.5|<0.0001
72445356|NCT05493787|144405900|SUPERIORITY|||||||0.952||||||Comparisons between Active Control and all other arms (Analyses 6-9) were analyzed in the same regression. The p-value reported is 2-tailed.|Regression, Linear|||Null hypothesis: Active Control messages and Protect Yourself - Rare messages are equally effective at promoting flu shot self-scheduling; Alternative hypothesis: Protect Yourself - Rare messages are more effective at promoting flu shot self-scheduling than Active Control messages. Analysis combines across November and December send dates.||||.952
72445357|NCT05493787|144405900|SUPERIORITY|||||||0.386||||||Comparisons between Active Control and all other arms (Analyses 6-9) were analyzed in the same regression. The p-value reported is 2-tailed.|Regression, Linear|||Null hypothesis: Active Control messages and Protect Yourself - Frequent messages are equally effective at promoting flu shot self-scheduling; Alternative hypothesis: Protect Yourself - Frequent messages are more effective at promoting flu shot self-scheduling than Active Control messages. Analysis combines across November and December send dates.||||.386
72445358|NCT05493787|144405900|SUPERIORITY|||||||0.498||||||Pairwise comparisons between experimental arms (Analyses 10-15) were analyzed in the same regression. Reported p-values were 2-tailed and adjusted using Tukey's HSD test.|Regression, Linear|||Null hypothesis: Ease messages and Waiting for You messages are equally effective at promoting flu shot self-scheduling; Alternative hypothesis: There is a difference in effectiveness between Ease and Waiting for You messages. Analysis combines across November and December send dates.||||.498
72445359|NCT05493787|144405900|SUPERIORITY|||||||0.935||||||Pairwise comparisons between experimental arms (Analyses 10-15) were analyzed in the same regression. Reported p-values were 2-tailed and adjusted using Tukey's HSD test.|Regression, Linear|||Null hypothesis: Ease messages and Protect Yourself - Rare messages are equally effective at promoting flu shot self-scheduling; Alternative hypothesis: There is a difference in effectiveness between Ease and Protect Yourself - Rare messages. Analysis combines across November and December send dates.||||.935
72445360|NCT05493787|144405900|SUPERIORITY|||||||0.504||||||Pairwise comparisons between experimental arms (Analyses 10-15) were analyzed in the same regression. Reported p-values were 2-tailed and adjusted using Tukey's HSD test.|Regression, Linear|||Null hypothesis: Ease messages and Protect Yourself - Frequent messages are equally effective at promoting flu shot self-scheduling; Alternative hypothesis: There is a difference in effectiveness between Ease and Protect Yourself - Frequent message messages. Analysis combines across November and December send dates.||||.504
72445361|NCT05493787|144405900|SUPERIORITY|||||||0.19||||||Pairwise comparisons between experimental arms (Analyses 10-15) were analyzed in the same regression. Reported p-values were 2-tailed and adjusted using Tukey's HSD test.|Regression, Linear|||Null hypothesis: Protect Yourself - Rare and Waiting for You messages are equally effective at promoting flu shot self-scheduling; Alternative hypothesis: There is a difference in effectiveness between Protect Yourself - Rare and Waiting for You messages. Analysis combines across November and December send dates.||||.190
72445362|NCT05493787|144405900|SUPERIORITY|||||||0.027||||||Pairwise comparisons between experimental arms (Analyses 10-15) were analyzed in the same regression. Reported p-values were 2-tailed and adjusted using Tukey's HSD test.|Regression, Linear|||Null hypothesis: Protect Yourself - Frequent messages and Waiting for You messages are equally effective at promoting flu shot self-scheduling; Alternative hypothesis: There is a difference in effectiveness between Protect Yourself - Frequent and Waiting for You messages. Analysis combines across November and December send dates.||||.027
72445363|NCT05493787|144405900|SUPERIORITY|||||||0.854||||||Pairwise comparisons between experimental arms (Analyses 10-15) were analyzed in the same regression. Reported p-values were 2-tailed and adjusted using Tukey's HSD test.|Regression, Linear|||Null hypothesis: Protect Yourself - Rare and Protect Yourself - Frequent messages are equally effective at promoting flu shot self-scheduling; Alternative hypothesis: There is a difference in effectiveness between Protect Yourself - Rare and Protect Yourself - Frequent messages. Analysis combines across November and December send dates.||||.854
72445364|NCT05493787|144405900|SUPERIORITY|||||||0.637||||||The reported p-value (2-tailed) is for the interaction term between message send date (November, December) and message (any message arm no message)|Regression, Linear|||"Null Hypothesis: Messages sent in November and December are equally effective at promoting flu-shot self-scheduling. Alternative hypothesis: Messages sent in November and December are differentially effective.~To test the alternative hypothesis, all message arms (Active control, Ease, Waiting for you, Protect yourself - rare, Protect yourself - frequent) were combined and compared with Passive control."||||.637
72445365|NCT06074523|144405960|EQUIVALENCE|Comparing three conditions in a basic science experiment in healthy adults.|partial eta squared|0.81|||<|0.001|TWO_SIDED||||||ANOVA|||Comparing Cued Suppression Task; Positive, Negative, and Neutral Cue condtions||||<.001
72445366|NCT06074523|144405961|EQUIVALENCE|P\<.05 criterion|cohen's d|0.24||||0.08|TWO_SIDED||||||t-test, 2 sided|||Comparing performance on target absent and target present trials||||.08
72445367|NCT06074523|144405962|OTHER||Slope|-0.37||||0.007|TWO_SIDED|95.0|-0.5803|-0.1135|||correlation|||Relationship between Cued Attention Negative Cue Benefit (Neutral Cue RT- Negative Cue RT) and working memory capacity.||-0.1135|-0.5803|.007
72445368|NCT06074523|144405963|OTHER||Slope|-0.27||||0.046|TWO_SIDED|95.0|-0.5015|-0.002414|||correlation|||Correlation of Inattentive Traits subscale and learned suppression (difference in RT between target absent and target present trials)||-0.002414|-0.5015|.046
72445369|NCT03143153|144405994|SUPERIORITY||Hazard Ratio (HR)|0.64||||0.001|TWO_SIDED|98.6|0.46|0.9||Log-rank test stratified by ECOG Performance Status (0 vs 1), number of organs with metastases (\<= 1 vs. \>= 2) as recorded in IRT.|Log Rank||Stratified Cox proportional hazard model.|Hazard Ratio is Arm A: Nivolumab + Ipilimumab over Arm C: Chemotherapy.||0.90|0.46|0.0010
72445370|NCT03143153|144405994|SUPERIORITY||Hazard Ratio (HR)|0.64||||0.001|TWO_SIDED|95.0|0.49|0.84||Log-rank test stratified by ECOG Performance Status (0 vs 1), number of organs with metastases (\<= 1 vs. \>= 2) as recorded in IRT.|Log Rank||Stratified Cox proportional hazard model|Hazard Ratio is Arm A: Nivolumab + Ipilimumab over Arm C: Chemotherapy.||0.84|0.49|0.0010
72497594|NCT00364182|144525068|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.0||||0.2167|TWO_SIDED|95.0|-1.2|5.2||P-values based on a model including terms for treatment regimen, treatment sequence, and the interaction of these terms with repeated measures on participants.|ANOVA|||||5.2|-1.2|0.2167
72389714|NCT01637935|144287378|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.2||||||95.0|0.83|1.75||||||Time since starting pioglitazone \>8 years vs unexposed group. Fully adjusted including all potential confounders in statistical model from 5-year interim report plus year of cohort entry: age, sex, race/ethnicity, other diabetes medications, smoking, other bladder conditions, median household income, congestive heart failure, cancer other than bladder, renal insufficiency, HbA1c and interaction with new diagnosis of diabetes, duration of diabetes, year of cohort entry and proteinuria.||1.75|0.83|
72445371|NCT03143153|144405994|SUPERIORITY||Hazard Ratio (HR)|0.54|||<|0.0001|TWO_SIDED|99.5|0.37|0.8||Log-rank test stratified by ECOG Performance Status (0 vs 1), number of organs with metastases (\<= 1 vs. \>= 2) as recorded in IRT.|Log Rank||Stratified Cox proportional hazard model|Hazard Ratio is Arm B: Nivolumab + Chemotherapy over Arm C: Chemotherapy||0.80|0.37|<0.0001
72389715|NCT01637935|144287379|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.88||||||95.0|0.68|1.16||||||Duration of therapy \<1.5 years. Fully adjusted including all potential confounders in statistical model from 5-year interim report plus year of cohort entry: age, sex, race/ethnicity, other diabetes medications, smoking, other bladder conditions, median household income, congestive heart failure, cancer other than bladder, renal insufficiency, HbA1c and interaction with new diagnosis of diabetes, duration of diabetes, year of cohort entry and proteinuria.||1.16|0.68|
72389716|NCT01637935|144287379|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.03||||||95.0|0.8|1.33||||||Duration of therapy 1.5-4 years. Fully adjusted including all potential confounders in statistical model from 5-year interim report plus year of cohort entry: age, sex, race/ethnicity, other diabetes medications, smoking, other bladder conditions, median household income, congestive heart failure, cancer other than bladder, renal insufficiency, HbA1c and interaction with new diagnosis of diabetes, duration of diabetes, year of cohort entry and proteinuria.||1.33|0.80|
72389717|NCT01637935|144287379|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.16||||||95.0|0.87|1.54||||||Duration of therapy \>4 years. Fully adjusted including all potential confounders in statistical model from 5-year interim report plus year of cohort entry: age, sex, race/ethnicity, other diabetes medications, smoking, other bladder conditions, median household income, congestive heart failure, cancer other than bladder, renal insufficiency, HbA1c and interaction with new diagnosis of diabetes, duration of diabetes, year of cohort entry and proteinuria.||1.54|0.87|
72389718|NCT01637935|144287380|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.9||||||95.0|0.69|1.16||||||Cumulative dose 1-14000 mg. Fully adjusted including all potential confounders in statistical model from 5-year interim report plus year of cohort entry: age, sex, race/ethnicity, other diabetes medications, smoking, other bladder conditions, median household income, congestive heart failure, cancer other than bladder, renal insufficiency, HbA1c and interaction with new diagnosis of diabetes, duration of diabetes, year of cohort entry and proteinuria.||1.16|0.69|
72389719|NCT01637935|144287380|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.1||||||95.0|0.85|1.42||||||Cumulative dose 14001-40000 mg. Fully adjusted including all potential confounders in statistical model from 5-year interim report plus year of cohort entry: age, sex, race/ethnicity, other diabetes medications, smoking, other bladder conditions, median household income, congestive heart failure, cancer other than bladder, renal insufficiency, HbA1c and interaction with new diagnosis of diabetes, duration of diabetes, year of cohort entry and proteinuria.||1.42|0.85|
72389720|NCT01637935|144287380|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.07||||||95.0|0.79|1.44||||||Cumulative dose \>40000 mg. Fully adjusted including all potential confounders in statistical model from 5-year interim report plus year of cohort entry: age, sex, race/ethnicity, other diabetes medications, smoking, other bladder conditions, median household income, congestive heart failure, cancer other than bladder, renal insufficiency, HbA1c and interaction with new diagnosis of diabetes, duration of diabetes, year of cohort entry and proteinuria.||1.44|0.79|
72389721|NCT00709761|144287382|SUPERIORITY_OR_OTHER||percentage of participants|53.0||||||95.0|40.7|66.0|||||The estimation parameter represents the percentage of participants experiencing either a CR or a PR.|||66.0|40.7|
72389722|NCT03311724|144287389|SUPERIORITY||Mean Difference (Final Values)|-1.9|||<|0.001|TWO_SIDED|95.0|-2.5|-1.4|||Mixed Models Analysis|||||-1.4|-2.5|<0.001
72389723|NCT03311724|144287389|SUPERIORITY||Mean Difference (Final Values)|-2.2|||<|0.001|TWO_SIDED|95.0|-2.8|-1.7|||Mixed Models Analysis|||||-1.7|-2.8|<0.001
72389724|NCT03311724|144287389|SUPERIORITY||Mean Difference (Final Values)|-2.0|||<|0.001|TWO_SIDED|95.0|-2.5|-1.4|||Mixed Models Analysis|||||-1.4|-2.5|<0.001
72389725|NCT03311724|144287390|SUPERIORITY||Odds Ratio (OR)|56.54|||<|0.001|TWO_SIDED|95.0|9.43|338.97|||Regression, Logistic|||||338.97|9.43|<0.001
72389726|NCT03311724|144287390|SUPERIORITY||Odds Ratio (OR)|183.48|||<|0.001|TWO_SIDED|95.0|22.0|999.0|||Regression, Logistic||"Maximum confidential interval is \>999"|||999|22.0|<0.001
72389727|NCT03311724|144287390|SUPERIORITY||Odds Ratio (OR)|157.54|||<|0.001|TWO_SIDED|95.0|21.63|999.0|||Regression, Logistic||"Maximum confidential interval is \>999"|||999|21.63|<0.001
72389728|NCT03311724|144287391|SUPERIORITY||Mean Difference (Final Values)|-48.5|||<|0.001|TWO_SIDED|95.0|-70.6|-26.3|||Mixed Models Analysis|||||-26.3|-70.6|<0.001
72389729|NCT03311724|144287391|SUPERIORITY||Mean Difference (Final Values)|-58.0|||<|0.001|TWO_SIDED|95.0|-80.7|-35.2|||Mixed Models Analysis|||||-35.2|-80.7|<0.001
72389730|NCT03311724|144287391|SUPERIORITY||Mean Difference (Final Values)|-61.9|||<|0.001|TWO_SIDED|95.0|-84.6|-39.2|||Mixed Models Analysis|||||-39.2|-84.6|<0.001
72389731|NCT03311724|144287392|SUPERIORITY||Mean Difference (Final Values)|-4.8|||<|0.001|TWO_SIDED|95.0|-7.1|-2.6|||Mixed Models Analysis|||||-2.6|-7.1|<0.001
72389732|NCT03311724|144287392|SUPERIORITY||Mean Difference (Final Values)|-5.0|||<|0.001|TWO_SIDED|95.0|-7.2|-2.7|||Mixed Models Analysis|||||-2.7|-7.2|<0.001
72389733|NCT03311724|144287392|SUPERIORITY||Mean Difference (Final Values)|-5.2|||<|0.001|TWO_SIDED|95.0|-7.5|-2.9|||Mixed Models Analysis|||||-2.9|-7.5|<0.001
72389734|NCT03311724|144287393|SUPERIORITY||Mean Difference (Final Values)|-2.2||||0.075|TWO_SIDED|95.0|-4.7|0.2|||Mixed Models Analysis|||||0.2|-4.7|0.075
72389735|NCT03311724|144287393|SUPERIORITY||Mean Difference (Final Values)|-2.4||||0.065|TWO_SIDED|95.0|-4.9|0.1|||Mixed Models Analysis|||||0.1|-4.9|0.065
72389736|NCT03311724|144287393|SUPERIORITY||Mean Difference (Final Values)|-2.4||||0.065|TWO_SIDED|95.0|-4.9|0.2|||Mixed Models Analysis|||||0.2|-4.9|0.065
72389737|NCT00844831|144287405|SUPERIORITY|||||||0.75|||||||t-test, 2 sided|||||||0.75
72389738|NCT00844831|144287407|OTHER|||||||0.9|||||||Wilcoxon (Mann-Whitney)|||||||.9
72445372|NCT03143153|144405994|SUPERIORITY||Hazard Ratio (HR)|0.54|||<|0.0001|TWO_SIDED|95.0|0.41|0.71||Log-rank test stratified by ECOG Performance Status (0 vs 1), number of organs with metastases (\<= 1 vs. \>= 2) as recorded in IRT.|Log Rank||Stratified Cox proportional hazard model|Hazard Ratio is Arm B: Nivolumab + Chemotherapy over Arm C: Chemotherapy||0.71|0.41|<0.0001
72445373|NCT03143153|144405995|SUPERIORITY||Hazard Ratio (HR)|1.02||||0.8958|TWO_SIDED|98.5|0.73|1.43||Log-rank test stratified by ECOG Performance Status (0 vs 1), number of organs with metastases (\<= 1 vs. \>= 2) as recorded in IRT|Log Rank||Stratified Cox proportional hazard model|Hazard Ratio is Arm A: Nivolumab + Ipilimumab over Arm C: Chemotherapy||1.43|0.73|0.8958
72445374|NCT03143153|144405995|SUPERIORITY||Hazard Ratio (HR)|1.02||||0.8958|TWO_SIDED|95.0|0.78|1.34||Log-rank test stratified by ECOG Performance Status (0 vs 1), number of organs with metastases (\<= 1 vs. \>= 2) as recorded in IRT|Log Rank||Stratified Cox proportional hazard model|Hazard Ratio is Arm A: Nivolumab + Ipilimumab over Arm C: Chemotherapy||1.34|0.78|0.8958
72445375|NCT03143153|144405995|SUPERIORITY||Hazard Ratio (HR)|0.65||||0.0023|TWO_SIDED|98.5|0.46|0.92||Log-rank test stratified by ECOG Performance Status (0 vs 1), number of organs with metastases (\<= 1 vs. \>= 2) as recorded in IRT|Log Rank||Stratified Cox proportional hazard model|Hazard Ratio is Arm B: Nivolumab + Chemotherapy over Arm C: Chemotherapy||0.92|0.46|0.0023
72445376|NCT03143153|144405995|SUPERIORITY||Hazard Ratio (HR)|0.65||||0.0023|TWO_SIDED|95.0|0.49|0.86||Log-rank test stratified by ECOG Performance Status (0 vs 1), number of organs with metastases (\<= 1 vs. \>= 2) as recorded in IRT|Log Rank||Stratified Cox proportional hazard model|Hazard Ratio is Arm B: Nivolumab + Chemotherapy over Arm C: Chemotherapy||0.86|0.49|0.0023
72445377|NCT03143153|144405996|SUPERIORITY||Hazard Ratio (HR)|0.78||||0.011||95.0|0.65|0.95||Log-rank test stratified by ECOG Performance Status (0 vs 1), number of organs with metastases (\<= 1 vs. \>= 2), PD-L1 status (\>= 1% vs. \< 1% or indeterminate) as recorded in IRT|Log Rank||Stratified Cox proportional hazard model|Hazard Ratio is Arm A: Nivolumab + Ipilimumab over Arm C: Chemotherapy||0.95|0.65|0.0110
72497595|NCT00364182|144525069|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.4||||0.002|TWO_SIDED|95.0|0.1|0.6|||ANOVA|||Mean difference in duration of sleep on the first night (24 hours post-bleed) and the second night (48 hours post-bleed).||0.6|0.1|0.002
72619283|NCT01654250|144769240|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.6|STANDARD_ERROR_OF_MEAN|2.28||0.496|TWO_SIDED|95.0|-6.0|2.9|||Mixed Models Analysis|||Hour 13 post-dose: Nominal p value-treatment comparisons for observed scores were assessed using a mixed model repeated measures analysis, with treatment (NWP09/Placebo), study center, time point and time point by treatment interaction as main effects and participant intercept as a random effect.||2.9|-6.0|0.496
72445378|NCT03143153|144405996|SUPERIORITY||Hazard Ratio (HR)|0.78||||0.011||98.2|0.62|0.98||Log-rank test stratified by ECOG Performance Status (0 vs 1), number of organs with metastases (\<= 1 vs. \>= 2), PD-L1 status (\>= 1% vs. \< 1% or indeterminate) as recorded in IRT.|Log Rank||Stratified Cox proportional hazard model|Hazard Ratio is Arm A: Nivolumab + Ipilimumab over Arm C: Chemotherapy||0.98|0.62|0.0110
72445379|NCT03143153|144405996|SUPERIORITY||Hazard Ratio (HR)|0.74||||0.0021||99.1|0.58|0.96||Log-rank test stratified by ECOG Performance Status (0 vs 1), number of organs with metastases (\<= 1 vs. \>= 2), PD-L1 status (\>= 1% vs. \< 1% or indeterminate) as recorded in IRT|Log Rank||Stratified Cox proportional hazard model|Hazard Ratio is Arm B: Nivolumab + Chemotherapy over Arm C: Chemotherapy||0.96|0.58|0.0021
72445380|NCT03143153|144405996|SUPERIORITY||Hazard Ratio (HR)|0.74||||0.0021|TWO_SIDED|95.0|0.61|0.9||Log-rank test stratified by ECOG Performance Status (0 vs 1), number of organs with metastases (\<= 1 vs. \>= 2), PD-L1 status (\>= 1% vs. \< 1% or indeterminate) as recorded in IRT|Log Rank||Stratified Cox proportional hazard model|Hazard Ratio is Arm B: Nivolumab + Chemotherapy over Arm C: Chemotherapy||0.90|0.61|0.0021
72445381|NCT03143153|144405997|SUPERIORITY||Hazard Ratio (HR)|1.26|||||TWO_SIDED|95.0|1.04|1.52|||||Stratified Cox proportional hazard model|Hazard Ratio is Arm A: Nivolumab + Ipilimumab over Arm C: Chemotherapy||1.52|1.04|
72445382|NCT03143153|144405997|SUPERIORITY||Hazard Ratio (HR)|0.81||||0.0355|TWO_SIDED|95.0|0.67|0.99||Log-rank test stratified by ECOG Performance Status (0 vs 1), number of organs with metastases (\<= 1 vs. \>= 2), PD-L1 status (\>= 1% vs. \< 1% or indeterminate) as recorded in IRT|Log Rank||Stratified Cox proportional hazard model|Hazard Ratio is Arm B: Nivolumab + Chemotherapy over Arm C: Chemotherapy||0.99|0.67|0.0355
72445383|NCT03143153|144405997|SUPERIORITY||Hazard Ratio (HR)|0.81||||0.0355|TWO_SIDED|98.5|0.64|1.04||Log-rank test stratified by ECOG Performance Status (0 vs 1), number of organs with metastases (\<= 1 vs. \>= 2), PD-L1 status (\>= 1% vs. \< 1% or indeterminate) as recorded in IRT|Log Rank||Stratified Cox proportional hazard model|Hazard Ratio is Arm B: Nivolumab + Chemotherapy over Arm C: Chemotherapy||1.04|0.64|0.0355
72445384|NCT02312557|144405999|OTHER||Proportion|0.19|||<|0.01|TWO_SIDED|95.0|0.09|0.29|||One-sample binomial test of proportion|||||0.29|0.09|<0.01
72445385|NCT04784559|144406037|SUPERIORITY||Hazard Ratio (HR)|1.06||||0.8751|TWO_SIDED|95.0|0.727|1.53||Unadjusted 2-sided p-value, for multiplicity adjustment uses the Hochberg step-up procedure|Log Rank|Stratified log-rank test, including the fixed effect of the treatment group and levels of the randomisation stratification factors|Stratified Cox proportional-hazards regression model, including the fixed effect of the treatment group and levels of the randomisation stratification factors,|Plitidepsin 2.5 mg arm versus Control arm||1.53|0.727|0.8751
72445386|NCT04784559|144406037|SUPERIORITY||Hazard Ratio (HR)|1.37||||0.0625|TWO_SIDED|95.0|0.96|1.96||Unadjusted 2-sided p-value, for multiplicity adjustment uses the Hochberg step-up procedure|Log Rank|Stratified log-rank test, including the fixed effect of the treatment group and levels of the randomisation stratification factors|Stratified Cox proportional-hazards regression model, including the fixed effect of the treatment group and levels of the randomisation stratification factors|Plitidepsin 1.5 mg arm versus Control arm||1.96|0.960|0.0625
72497596|NCT00364182|144525069|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.4||||0.021|TWO_SIDED|95.0|0.1|0.8|||ANOVA|||Mean difference in duration of sleep on the first night (24 hours post-bleed) and the second night (48 hours post-bleed).||0.8|0.1|0.021
72497597|NCT00364182|144525069|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.6||||0.004|TWO_SIDED|95.0|0.2|0.9|||ANOVA|||Mean difference in duration of sleep on the first night (24 hours post-bleed) and the second night (48 hours post-bleed).||0.9|0.2|0.004
72619284|NCT01654250|144769240|SUPERIORITY_OR_OTHER|||||||0.133|||||||Mixed Models Analysis|||Hour 13 post-dose: Adjusted p-value were generated using a fixed sequence testing procedure from p-values generated from the mixed effects model.||||0.133
72619285|NCT01654250|144769241|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.5|STANDARD_ERROR_OF_MEAN|0.56||0.007|TWO_SIDED|95.0|-2.6|-0.4|||Mixed Models Analysis|||Hour 0.75 post-dose attention subscale: Treatment comparisons for observed scores were assessed using a mixed model repeated measures analysis, with treatment (NWP09/Placebo), study center, time point and time point by treatment interaction as main effects and participant intercept as a random effect.||-0.4|-2.6|0.007
72389739|NCT02957305|144287408|NON_INFERIORITY|400µg of misoprostol yields a 96% cervical dilation \> 8 mm. We considered 86% of the 200 µg misoprostol group as the minimal acceptable percentage. The non-inferiority margin was determined by 24.46.|treatment difference|25.0||||0.025|ONE_SIDED|95.0||97.5||The null hypothesis: percentage of dilation with 400µg ≥ percentage of dilation with 200µg + 25% Alternative hypothesis: percentage of dilation with 400µg - 25% \< percentage of dilation with 200µg|difference between proportions|difference between percentages and 95% confidence interval||If there is a true difference in favour of the standard treatment of 10% (96% vs 86%), then 184 patients are required to be 95% sure that the upper limit of a one-sided 97.5% confidence interval (or equivalently a 95% two-sided confidence interval) will exclude a difference in favour of the standard group of more than 25%||97.5||0.025
72389740|NCT02957305|144287408|NON_INFERIORITY|The non-inferiority margin was determined by ⅓ of the difference between the 400µg effect (96.7%), compared to the 200 µg dose (23.3%), i.e. 73.4 / 3 = 24.46%|Difference between proportions|0.1146||||0.004|TWO_SIDED|95.0|0.037|0.192|||Chi-squared||The difference between both groups was 11.5% (95%CI = 3.7% to 19.2%)|||0.192|0.037|0.004
72389741|NCT02957305|144287410|SUPERIORITY||Median Difference (Final Values)|0.0||||0.9|TWO_SIDED|95.0|0.0|0.0|||Wilcoxon (Mann-Whitney)|||||0|0|0.9
72389742|NCT03486223|144287442|SUPERIORITY|||||||0.71||||||Wilcoxon signed-rank test was used for the within-subject comparison of GSK2256294 versus placebo.|Wilcoxon (Mann-Whitney)|||A sample size of 16 per group was estimated to have 86% power to detect a within-subject difference of 3.76 (80% of the above difference) or larger (with an SD for the within-subject difference of 4.6) in insulin sensitivity.||||0.71
72389743|NCT01749137|144287459|SUPERIORITY|P-value from a mixed-effects analysis of covariance model with treatment, visit and visit-by-treatment interaction as factors, baseline weight as a covariate, and participant as the random effect.|Treatment Difference|-1.1|STANDARD_ERROR_OF_MEAN|0.58||0.059|TWO_SIDED|95.0|-2.27|0.04|||Mixed Model Repeated Measures (MMRM)|||||0.04|-2.27|0.059
72389744|NCT01749137|144287460|SUPERIORITY|P-value from a mixed-effects analysis of covariance model with treatment, visit and visit-by-treatment interaction as factors, baseline weight as a covariate, and participant as the random effect.|Treatment Difference|-1.2|STANDARD_ERROR_OF_MEAN|0.66||0.079|TWO_SIDED|95.0|-2.48|0.14|||MMRM|||||0.14|-2.48|0.079
72389745|NCT01749137|144287461|SUPERIORITY|||||||0.513||||||P-values from a Cochran-Mantel-Haenszel (CMH) test, controlling for site and the stratification factor severely obese (yes/no).|Cochran-Mantel-Haenszel|||||||0.513
72389746|NCT01749137|144287469|SUPERIORITY|P-value from a mixed-effects analysis of covariance model with treatment, visit and visit-by-treatment interaction as factors, baseline weight as a covariate, and participant as the random effect.|Treatment Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.87||0.387|TWO_SIDED|95.0|-2.5|0.98|||MMRM|||||0.98|-2.50|0.387
72389747|NCT01749137|144287470|SUPERIORITY|||||||1||||||P-values from a Cochran-Mantel-Haenszel (CMH) test, controlling for site.|Cochran-Mantel-Haenszel|||||||1.000
72389748|NCT01758432|144287471|SUPERIORITY||Least Squares Means (Difference)|-95.74|||<|0.0001|TWO_SIDED|95.0|||||ANCOVA|||||||<0.0001
72389749|NCT01758432|144287471|SUPERIORITY||Least Squares Means (Difference)|-130.5|||<|0.0001|TWO_SIDED|95.0|||||ANCOVA|||||||<0.0001
72389750|NCT01758432|144287471|SUPERIORITY||Least Squares Means (Difference)|-129.86|||<|0.0001|TWO_SIDED|95.0|||||ANCOVA|||||||<0.0001
72389751|NCT01758432|144287471|SUPERIORITY||Least Squares Means (Difference)|-165.91|||<|0.0001|TWO_SIDED|95.0|||||ANCOVA|||||||<0.0001
72389752|NCT01758432|144287471|SUPERIORITY||Least Squares Means (Difference)|-167.94|||<|0.0001|TWO_SIDED|95.0|||||ANCOVA|||||||<0.0001
72389753|NCT01758432|144287471|SUPERIORITY||Least Squares Means (Difference)|-135.91|||<|0.0001|TWO_SIDED|95.0|||||ANCOVA|||||||<0.0001
72389754|NCT01758432|144287472|SUPERIORITY||Least Squares Means (Difference)|85559.49||||0.0004|TWO_SIDED|95.0|||||ANCOVA|||||||0.0004
72389755|NCT01758432|144287472|SUPERIORITY||Least Squares Means (Difference)|105508.3|||<|0.0001|TWO_SIDED|95.0|||||ANCOVA|||||||<0.0001
72389756|NCT01758432|144287472|SUPERIORITY||Least Squares Means (Difference)|182753.2|||<|0.0001|TWO_SIDED|95.0|||||ANCOVA|||||||<0.0001
72389757|NCT01758432|144287472|SUPERIORITY||Least Squares Means (Difference)|193684.5|||<|0.0001|TWO_SIDED|95.0|||||ANCOVA|||||||<0.0001
72497598|NCT00364182|144525069|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.4||||0.093|TWO_SIDED|95.0|-0.1|0.8|||ANOVA|||Mean difference in duration of sleep on the first night (24 hours post-bleed) and the second night (48 hours post-bleed).||0.8|-0.1|0.093
72389758|NCT01758432|144287472|SUPERIORITY||Least Squares Means (Difference)|178055.0|||<|0.0001|TWO_SIDED|95.0|||||ANCOVA|||||||<0.0001
72389759|NCT01758432|144287472|SUPERIORITY||Least Squares Means (Difference)|169709.9|||<|0.0001|TWO_SIDED|95.0|||||ANCOVA|||||||<0.0001
72389760|NCT01758432|144287473|SUPERIORITY||Least Squares Means (Difference)|-4.58|||<|0.0001|TWO_SIDED|95.0|||||ANCOVA|||||||<0.0001
72389761|NCT01758432|144287473|SUPERIORITY||Least Squares Means (Difference)|-4.29|||<|0.0001|TWO_SIDED|95.0|||||ANCOVA|||||||<0.0001
72389762|NCT01758432|144287473|SUPERIORITY||Least Squares Means (Difference)|-6.15|||<|0.0001|TWO_SIDED|95.0|||||ANCOVA|||||||<0.0001
72389763|NCT01758432|144287473|SUPERIORITY||Least Squares Means (Difference)|-6.79|||<|0.0001|TWO_SIDED|95.0|||||ANCOVA|||||||<0.0001
72389764|NCT01758432|144287473|SUPERIORITY||Least Squares Means (Difference)|-7.49|||<|0.0001|TWO_SIDED|95.0|||||ANCOVA|||||||<0.0001
72389765|NCT01758432|144287473|SUPERIORITY||Least Squares Means (Difference)|-6.71|||<|0.0001|TWO_SIDED|95.0|||||ANCOVA|||||||<0.0001
72389766|NCT01803204|144287485|SUPERIORITY_OR_OTHER||GEE|1.0||||1|TWO_SIDED|99.0|||||GEE|||||||1.00
72389767|NCT01803204|144287486|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED|99.0|||||Mist Effects Model|||||||<0.01
72389768|NCT01803204|144287487|SUPERIORITY_OR_OTHER|||||||0.81|TWO_SIDED|99.0|||||Mist Effect Model|||||||0.81
72445387|NCT04784559|144406038|SUPERIORITY||Hazard Ratio (HR)|0.948||||0.5945|TWO_SIDED|95.0|0.655|1.37||Unadjusted 2-sided p-value, for multiplicity adjustment uses the Hochberg step-up procedure|Log Rank|Stratified log-rank test, including the fixed effect of the treatment group and levels of the randomisation stratification factors|Stratified Cox proportional-hazards regression model, including the fixed effect of the treatment group and levels of the randomisation stratification factors|Plitidepsin 2.5 mg arm versus Control arm||1.37|0.655|0.5945
72445388|NCT04784559|144406038|SUPERIORITY||Hazard Ratio (HR)|1.18||||0.3358|TWO_SIDED|95.0|0.827|1.7||Unadjusted 2-sided p-value, for multiplicity adjustment uses the Hochberg step-up procedure|Log Rank|Stratified log-rank test, including the fixed effect of the treatment group and levels of the randomisation stratification factors|Stratified Cox proportional-hazards regression model, including the fixed effect of the treatment group and levels of the randomisation stratification factors|Plitidepsin 1.5 mg arm versus Control arm||1.70|0.827|0.3358
72445389|NCT04784559|144406039|SUPERIORITY||Odds Ratio (OR)|1.12||||0.7252|TWO_SIDED|95.0|0.604|2.06||2-sided|p-value based on proportional odds model|Proportional odds model with fixed effects of treatment group and randomisation stratification factors|Adjusted Odds Ratio and 95% CI based on a proportional odds model with fixed effects of treatment group and randomisation stratification factors|Plitidepsin 2.5 mg arm versus Control arm||2.06|0.604|0.7252
72445390|NCT04784559|144406039|SUPERIORITY||Odds Ratio (OR)|1.69||||0.091|TWO_SIDED|95.0|0.92|3.11||2-sided|p-value based on proportional odds model|Proportional odds model with fixed effects of treatment group and randomisation stratification factors|Adjusted Odds Ratio and 95% CI based on a proportional odds model with fixed effects of treatment group and randomisation stratification factors|Plitidepsin 1.5 mg arm versus Control arm||3.11|0.920|0.0910
72445391|NCT03661840|144406047|SUPERIORITY||Mean Difference (Final Values)|3.9|STANDARD_ERROR_OF_MEAN|17.0||0.82|TWO_SIDED|95.0|-31.0|39.0||Unadjusted model comparing the mean difference (change from 12 weeks - baseline) in outcome by intervention group.|Regression, Linear|||Sample size was estimated using d= 0.61, with power at 0.80 and α = .05, two-tailed. It is assumed that the correlation between pre and post-test measures will be high at .5. With these parameters and using repeated measures ANOVA to evaluate treatment difference, sample size is powered for clinical outcomes at 92 participants; with an estimated 30% attrition and conservatively including the possibility of screening failures, a maximum sample of 140 participants will be targeted for enrollment.||39|-31|0.82
72445392|NCT03661840|144406048|SUPERIORITY||Mean Difference (Final Values)|12.0|STANDARD_ERROR_OF_MEAN|6.4||0.06|TWO_SIDED|95.0|-0.7|25.0||Unadjusted model comparing the change in outcome by intervention group|Regression, Linear|||||25|-0.7|0.06
72445393|NCT03661840|144406048|SUPERIORITY||Mean Difference (Final Values)|0.61||||0.05|TWO_SIDED||||||ANOVA|||Sample size was estimated using d= 0.61, with power at 0.80 and α = .05, two-tailed. It is assumed that the correlation between pre and post-test measures will be high at .5. With these parameters and using repeated measures ANOVA to evaluate treatment difference, sample size is powered for clinical outcomes at 92 participants; with an estimated 30% attrition and conservatively including the possibility of screening failures, a maximum sample of 140 participants will be targeted for enrollment.||||0.05
72445394|NCT03443323|144406066|SUPERIORITY||||||<|0.001||||||Statistical significance was evaluated using a threshold p value of .0083, accounting for the estimation of three contrasts of time-by-treatment differences per outcome and two measures per domain (OTMP skills \[COSS-P, COSS-T\]).|Mixed Models Analysis|||||||<.001
72445395|NCT03443323|144406067|SUPERIORITY||||||<|0.001||||||Statistical significance was evaluated using a threshold p value of .0083, accounting for the estimation of three contrasts of time-by-treatment differences per outcome and two measures per domain (OTMP skills \[COSS-P, COSS-T\]).|Mixed Models Analysis|||||||<.001
72445396|NCT03443323|144406068|SUPERIORITY|||||||0.007||||||Statistical significance was evaluated using a threshold p value of .0083, accounting for the estimation of three contrasts of time-by-treatment differences per outcome and two measures per domain (homework performance \[HPC, HPQ-T\]).|Mixed Models Analysis|||||||0.007
72445397|NCT03443323|144406069|SUPERIORITY||||||<|0.001||||||Statistical significance was evaluated using a threshold p value of .0083, accounting for the estimation of three contrasts of time-by-treatment differences per outcome and two measures per domain (homework performance \[HPC, HPQ-T\]).|Mixed Models Analysis|||||||<.001
72445398|NCT03443323|144406070|SUPERIORITY||||||<|0.06||||||Statistical significance was evaluated using a threshold p value of .0083, accounting for the estimation of three contrasts of time-by-treatment differences per outcome and two measures per domain (academic performance \[ACES, APS\]).|Mixed Models Analysis|||||||<.06
72445399|NCT03443323|144406071|SUPERIORITY||||||>|0.0083||||||Statistical significance was evaluated using a threshold p value of .0083, accounting for the estimation of three contrasts of time-by-treatment differences per outcome and two measures per domain (academic performance \[ACES, APS\]).|Mixed Models Analysis|||||||>.0083
72445400|NCT03443323|144406072|SUPERIORITY||||||>|0.05||||||Statistical significance was evaluated using a threshold p value of .05.|Mixed Models Analysis|||||||>.05
72445401|NCT03443323|144406073|SUPERIORITY||||||>|0.05||||||Statistical significance was evaluated using a threshold p value of .05.|Mixed Models Analysis|||||||>.05
72445402|NCT03135548|144406077|OTHER|No formal hypothesis testing was performed in this trial.|Risk Difference (RD)|0.078|||||TWO_SIDED|95.0|-0.19|0.338|||Wilson/Newcombe|95% confidence intervals (CI) are calculated using the method of Wilson/Newcombe.|Unadjusted absolute risk difference versus placebo was calculated as the difference in the observed proportion of patients with ppPASI50 at Week 16 for each treatment scenario, for the FAS.|||0.338|-0.190|
72445403|NCT03135548|144406077|OTHER|No formal hypothesis testing was performed in this trial.|Risk Difference (RD)|0.078|||||TWO_SIDED|95.0|-0.19|0.338|||Wilson/Newcombe|95% CIs are calculated using the method of Wilson/Newcombe.|Unadjusted absolute risk difference versus placebo was calculated as the difference in the observed proportion of patients with ppPASI50 at Week 16 for each treatment scenario, for the FAS.|||0.338|-0.190|
72445404|NCT03135548|144406079|OTHER|No formal hypothesis testing was performed in this trial.|Risk Difference (RD)|-0.095|||||TWO_SIDED|95.0|-0.289|0.086|||Wilson/Newcombe|95% CIs are calculated using the method of Wilson/Newcombe.|Unadjusted absolute risk difference versus placebo was calculated as the difference in the observed proportion of patients with ppPASI50 at Week 16 for each treatment scenario, for the FAS.|||0.086|-0.289|
72497599|NCT00364182|144525070|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.3||||0|TWO_SIDED|95.0|-0.4|-0.1|||ANOVA|||Mean difference in quality of sleep on the first night (24 hours post-bleed) and the second night (48 hours post-bleed).||-0.1|-0.4|0.000
72445405|NCT03135548|144406079|OTHER|No formal hypothesis testing was performed in this trial.|Risk Difference (RD)|0.115|||||TWO_SIDED|95.0|-0.116|0.348|||Wilson/Newcombe|95% CIs are calculated using the method of Wilson/Newcombe.|Unadjusted absolute risk difference versus placebo was calculated as the difference in the observed proportion of patients with ppPASI50 at Week 16 for each treatment scenario, for the FAS.|||0.348|-0.116|
72445406|NCT03135548|144406080|OTHER|No formal hypothesis testing was performed in this trial.|Mean Difference (Final Values)|7.24|||||TWO_SIDED|95.0|-20.01|34.48|||Student's t-distribution|CIs were based on Student's t-distribution.||||34.48|-20.01|
72445407|NCT03135548|144406080|OTHER|No formal hypothesis testing was performed in this trial.|Mean Difference (Final Values)|-5.82|||||TWO_SIDED|95.0|-28.35|16.7|||Student's t-distribution|CIs were based on Student's t-distribution.||||16.70|-28.35|
72445408|NCT03135548|144406081|OTHER|No formal hypothesis testing was performed in this trial.|Risk Difference (RD)|-0.143|||||TWO_SIDED|95.0|-0.346|0.049|||Wilson/Newcombe|95% CIs are calculated using the method of Wilson/Newcombe.||||0.049|-0.346|
72445409|NCT03135548|144406081|OTHER|No formal hypothesis testing was performed in this trial.|Risk Difference (RD)|0.015|||||TWO_SIDED|95.0|-0.213|0.252|||Wilson/Newcombe|95% CIs are calculated using the method of Wilson/Newcombe.||||0.252|-0.213|
72445410|NCT03665597|144406090|OTHER|Geometric Least-Square Mean Ratio (GMR) = GM of Pembrolizumab 130 mg/mL SC/GM of Pembrolizumab 200 mg IV|GMR|0.73|||||TWO_SIDED|90.0|0.68|0.78||||||||0.78|0.68|
72497600|NCT00364182|144525070|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.3||||0|TWO_SIDED|95.0|-0.5|-0.2|||ANOVA|||Mean difference in quality of sleep on the first night (24 hours post-bleed) and the second night (48 hours post-bleed).||-0.2|-0.5|0.0000
72497601|NCT00364182|144525070|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.3||||0.002|TWO_SIDED|95.0|-0.5|-0.1|||ANOVA|||Mean difference in quality of sleep on the first night (24 hours post-bleed) and the second night (48 hours post-bleed).||-0.1|-0.5|0.002
72560739|NCT02959840|144651826|EQUIVALENCE|Our null hypothesis is that there is no statistically significant difference between the number of people who experienced vomiting in the above 2 groups.||||||0.0002|||||||Chi-squared|||||||0.0002
72560740|NCT02959840|144651826|EQUIVALENCE|Our null hypothesis is that there is no statistically significant difference between the number of people who experienced vomiting in the above 2 groups.||||||0.8|||||||Chi-squared|||||||0.8
72560741|NCT02959840|144651827|EQUIVALENCE|Our null hypothesis is that there is no statistically significant difference between the number of people who experienced nausea in the above 2 groups.||||||4e-05|||||||Chi-squared|||||||0.00004
72445411|NCT03665597|144406090|OTHER|GMR = GM of Pembrolizumab 165 mg/mL SC/GM of Pembrolizumab 200 mg IV|GMR|0.69|||||TWO_SIDED|90.0|0.64|0.74||||||||0.74|0.64|
72445412|NCT03665597|144406091|OTHER|GMR = GM of Pembrolizumab 130 mg/mL SC/GM of Pembrolizumab 200 mg IV|Geometric Least-Square Mean Ratio|0.4|||||TWO_SIDED|90.0|0.36|0.44||||||||0.44|0.36|
72445413|NCT03665597|144406091|OTHER|GMR = GM of Pembrolizumab 165 mg/mL SC/GM of Pembrolizumab 200 mg IV|Geometric Least-Square Mean Ratio|0.38|||||TWO_SIDED|90.0|0.34|0.41||||||||0.41|0.34|
72445414|NCT04410042|144406148|EQUIVALENCE|Two-sided test at 0.05 level.||||||0.4|||||||Wilcoxon rank sum test|||||||0.4000
72445415|NCT04410042|144406149|EQUIVALENCE|Two-sided test at 0.05 level.||||||0.4286|||||||Wilcoxon rank sum test|||||||0.4286
72445416|NCT04410042|144406150|EQUIVALENCE|Two-sided test at 0.05 level.||||||0.9307|||||||Wilcoxon rank sum test|||||||0.9307
72445417|NCT04410042|144406151|EQUIVALENCE|Two-sided test at 0.05 level.||||||0.0714|||||||Wilcoxon rank sum test|||||||0.0714
72445418|NCT04410042|144406152|EQUIVALENCE|Two-sided test at 0.05 level.||||||0.9004|||||||Wilcoxon rank sum test|||||||0.9004
72445419|NCT03649659|144406161|SUPERIORITY||Odds Ratio (OR)|4.06|||<|0.0001|TWO_SIDED|99.9|2.54|6.48|||Regression, Logistic|Multiple imputation (25) of missing data, FCS methods. Group comparisons using GEE logistic model, exchangeable correlation, study site as covariate.||||6.48|2.54|<0.0001
72445420|NCT03649659|144406162|SUPERIORITY||Odds Ratio (OR)|4.78|||<|0.0001|TWO_SIDED|99.9|2.84|8.05||Multiple imputation (25) of missing data, FCS methods. Group comparisons using GEE logistic model, exchangeable correlation, study site as covariate.|Regression, Logistic|||||8.05|2.84|<0.0001
72445421|NCT03649659|144406163|SUPERIORITY||Odds Ratio (OR)|5.84|||<|0.0001|TWO_SIDED|99.9|3.59|9.51||Multiple imputation (25) of missing data, FCS methods. Group comparisons using GEE logistic model, exchangeable correlation, study site as covariate.|Regression, Logistic|||||9.51|3.59|<0.0001
72445422|NCT03649659|144406164|SUPERIORITY||Odds Ratio (OR)|0.95||||0.8942|TWO_SIDED|99.9|0.25|3.54||Multiple imputation (25) of missing data, FCS methods. Group comparisons using GEE logistic model, exchangeable correlation, study site as covariate.|Regression, Logistic|||||3.54|0.25|0.8942
72445423|NCT01963793|144406191|SUPERIORITY||Mean Difference (Final Values)|-1.51||||0.58|TWO_SIDED|95.0|-7.12|4.11|||t-test, 2 sided|||||4.11|-7.12|0.58
72469788|NCT01575873|144463469|NON_INFERIORITY|Non-inferiority was shown if the lower bound of the two-sided 95% CI for the difference between the least-squares means (denosumab minus risedronate) was higher than the prespecified non-inferiority margin of -0.7 percentage points for the glucocorticoid-continuing subpopulation.|LS Mean Difference|2.2|||<|0.001|TWO_SIDED|95.0|1.4|3.0||One-sided p-value based on the prespecified noninferiority margins for lumbar spine of -0.7%.|ANCOVA||LS Mean Difference = Denosumab - Risedronate|"Analyses of the primary and secondary endpoints were performed independently within each subpopulation using a fixed-sequence testing procedure to control the experiment-wise type 1 error rate at a two-sided 5% significance level.~The glucocorticoid-continuing subpopulation was analyzed using an ANCOVA model adjusted for treatment, baseline BMD, sex, machine type, baseline BMD-by-machine type interaction, and duration of prior glucocorticoid use (\< 12 months vs ≥ 12 months)."||3.0|1.4|< 0.001
72497602|NCT00364182|144525070|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.3||||0.031|TWO_SIDED|95.0|-0.5|0.0|||ANOVA|||Mean difference in quality of sleep on the first night (24 hours post-bleed) and the second night (48 hours post-bleed).||-0.0|-0.5|0.031
72560742|NCT02959840|144651827|EQUIVALENCE|Our null hypothesis is that there is no statistically significant difference between the number of people who experienced nausea in the above 2 groups.||||||0.0004|||||||Chi-squared|||||||0.0004
72560743|NCT02959840|144651827|EQUIVALENCE|Our null hypothesis is that there is no statistically significant difference between the number of people who experienced nausea in the above 2 groups.||||||0.09|||||||Chi-squared|||||||0.09
72560744|NCT02959840|144651828|EQUIVALENCE|Our null hypothesis is that there is no statistically significant difference between the number of people who experienced nausea in the above 2 groups.||||||0.1|||||||Chi-squared|||||||0.1
72445424|NCT01552473|144406213|OTHER|This is a functional Magnetic Resonance Imaging analysis. We aimed to determine whether functional brain network connectivity was equivalent between the two intervention arms prior to the interventions beginning. This was computed in significant numbers of connections between the two groups.|pNBS|0.0001||||0.01|TWO_SIDED|||||This is a p-value that is used in Network Based Statistics analysis for resting-state functional brain network data.|Network Based Statistics analysis|This is a type of statistical analysis used to test for group differences among functional connectivity levels between two or more groups.|This analysis evaluated monotonic changes from time point 1 (pre-intervention) to time points 2 (immediate post-intervention) and 3 (12 weeks post-intervention) that may have occurred between the SMART and BHW groups.|A network-based statistics analysis was carried out to determine brain connectivity differences observed at time points two (initial post-intervention testing phase) and three (the final post-intervention phase) occurring three months post-intervention.||||0.01
72445425|NCT05089734|144406237|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.0534|TWO_SIDED|95.0|0.68|1.04||Stratified log-rank test adjusted for stratification factors: histology and best response to last prior immune therapy received.|Log Rank|||||1.04|0.68|0.0534
72445426|NCT05089734|144406238|SUPERIORITY||Hazard Ratio (HR)|0.92||||0.1938|TWO_SIDED|95.0|0.77|1.11||Stratified log-rank test adjusted for stratification factors: histology and best response to last prior immune therapy received.|Log Rank|||||1.11|0.77|0.1938
72445427|NCT05089734|144406239|SUPERIORITY||Difference in Proportions|-4.3||||0.9255|TWO_SIDED|95.0|-10.1|1.5||The 1-sided p-value is calculated using Cochran Mantel-Haenszel test adjusted for randomization stratification factors of histology, and best response to last prior immune therapy received.|Cochran-Mantel-Haenszel|||||1.5|-10.1|0.9255
72445428|NCT05089734|144406244|SUPERIORITY||Hazard Ratio (HR)|0.75||||0.002|TWO_SIDED|95.0|0.61|0.91||Stratified log-rank test adjusted for stratification factors: histology and best response to last prior immune therapy received.|Log Rank|||||0.91|0.61|0.0020
72497603|NCT00364182|144525074|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.1||||0.544|TWO_SIDED|95.0|-9.2|4.9|||ANOVA|||||4.9|-9.2|0.544
72497604|NCT00364182|144525074|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.6||||0.592|TWO_SIDED|95.0|-7.5|4.3|||ANOVA|||||4.3|-7.5|0.592
72497605|NCT00364182|144525074|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.6||||0.131|TWO_SIDED|95.0|-1.1|8.4|||ANOVA|||||8.4|-1.1|0.131
72560745|NCT02959840|144651828|EQUIVALENCE|Our null hypothesis is that there is no statistically significant difference between the number of people who experienced nausea in the above 2 groups.||||||0.07|||||||Chi-squared|||||||0.07
72445429|NCT05089734|144406245|SUPERIORITY||Hazard Ratio (HR)|0.8||||0.0125|TWO_SIDED|95.0|0.66|0.97||Stratified log-rank test adjusted for stratification factors: histology and best response to last prior immune therapy received.|Log Rank|||||0.97|0.66|0.0125
72445430|NCT01212029|144406260|OTHER|One sample t-tests of standardized regression coefficients of RMSSD predicting O2Hb during baseline||||||0.008||||||t-test was performed 16 times for 16 fNIRS channels. The reported p-value is an uncorrected value for channel 10.|t-test, 2 sided|||Null hypothesis: there is no significant correlation between RMSSD and O2Hb levels during baseline||||0.008
72445431|NCT01212029|144406261|OTHER|||||||0.0105|||||||Tukey method|||||||0.0105
72445432|NCT03131648|144406264|SUPERIORITY|Primary endpoints tested sequentially at a 5% significance level.|Risk Difference (RD)|8.6||||0.002|TWO_SIDED|95.0|4.1|13.1||Based on the primary analysis of the primary estimand 'composite'. Subjects with missing data or subjects who received rescue medication prior to Week 16 were considered non-responders.|Cochran-Mantel-Haenszel|Primary endpoints tested sequentially at a 5% significance level.|Mantel-Haenszel risk difference, stratified by region and baseline disease severity.|Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity.The null hypothesis of no difference in response rates between tralokinumab and placebo were tested against the 2-sided alternative that there is a difference.||13.1|4.1|0.002
72445433|NCT03131648|144406265|SUPERIORITY|Primary endpoints tested sequentially at a 5% significance level.|Risk Difference (RD)|12.1|||<|0.001|TWO_SIDED|95.0|6.5|17.7||Based on the primary analysis of the primary estimand 'composite'. Subjects with missing data or subjects who received rescue medication prior to Week 16 were considered non-responders.|Cochran-Mantel-Haenszel|Primary endpoints tested sequentially at a 5% significance level.|Mantel-Haenszel risk difference, stratified by region and baseline disease severity.|Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity. The null hypothesis of no difference in response rates between tralokinumab and placebo were tested against the 2-sided alternative that there is a difference.||17.7|6.5|<0.001
72445434|NCT03131648|144406266|SUPERIORITY||Risk Difference (RD)|9.7||||0.002|TWO_SIDED|95.0|4.4|15.0||Based on the primary analysis of the primary estimand 'Composite', subjects who received rescue medication prior to Week 16 or have missing data at Week 16 were considered as non-responders.|Cochran-Mantel-Haenszel|Tested sequentially at a 5% significance level.|Mantel-Haenszel risk difference, stratified by region and baseline disease severity.|Reduction of Worst Daily Pruritus NRS weekly average ≥4 at Week 16 was tested after the sequential testing of IGA 0/1 and EASI75 if these tests showed statistical significance.||15|4.4|0.002
72445435|NCT03131648|144406267|SUPERIORITY|Multiplicity adjustment using the Holm method.|Difference of least square means|-10.4|||<|0.001|TWO_SIDED|95.0|-14.4|-6.5||Based on the primary analysis of the primary estimand 'hypothetical'. Repeated measurements model on post-baseline data. In case of no post-baseline assessments before initiation of rescue medication, the Week 2 change was imputed as 0.|Repeated measurements model|||Data collected after permanent discontinuation of IMP or after initiation of rescue medication were not included in the analysis.||-6.5|-14.4|<0.001
72497606|NCT01261559|144525096|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.2|STANDARD_DEVIATION|10.0||0.003|TWO_SIDED|95.0|4.0|25.0|||Regression, Linear|A multivariate linear regression model was fitted for the main outcome of percent relative dose, with age, BMI, and bra cup size as covariates.||Powered to detect difference of 10% at 80% power if 66 or more subjects enrolled.||25|4|0.003
72497607|NCT02921425|144525105|OTHER|||||||0.003|||||||Wilcoxon (Mann-Whitney)|||||||.003
72497608|NCT02921425|144525107|OTHER|||||||0.007|||||||t-test, 2 sided|||||||.007
72497609|NCT02921425|144525108|OTHER|||||||0.026|||||||t-test, 2 sided|||||||.026
72560746|NCT02959840|144651828|EQUIVALENCE|Our null hypothesis is that there is no statistically significant difference between the number of people who experienced nausea in the above 2 groups.||||||0.7|||||||Chi-squared|||||||0.7
72497610|NCT02921425|144525110|OTHER|||||||0.003||||||systolic blood pressure|t-test, 2 sided|||||||.003
72445436|NCT03131648|144406268|SUPERIORITY|Multiplicity adjustment using Holm method.|Difference of least square means|-2.1||||0.002|TWO_SIDED|95.0|-3.4|-0.8||Based on the primary analysis of the primary estimand 'hypothetical'. Repeated measurements model on post-baseline data. In case of no post-baseline assessments before initiation of rescue medication, the Week 2 change was imputed as 0.|Repeated measurements model|||Data collected after permanent discontinuation of IMP or initiation of rescue medication not included.||-0.8|-3.4|0.002
72445437|NCT03131648|144406269|SUPERIORITY||Risk Difference (RD)|6.0||||0.68|TWO_SIDED|95.0|-21.8|33.7||"Based on the primary analysis of the 'composite' estimand. Subjects who received rescue medication or were transferred to open-label treatment were considered non-responders.~P value was considered non-significant."|Cochran-Mantel-Haenszel|This test was not statistically significant and hence next maintenance endpoint in the sequential testing procedure was not evaluated.|Mantel-Haenszel risk difference compared to placebo, stratified by region.|"Testing according to the hierarchical testing procedure in the order:~IGA 0/1 at Week 52 between Q2W vs Placebo, EASI75 at Week 52 between Q2W vs Placebo, IGA 0/1 at Week 52 between Q4W vs Placebo, and EASI75 at Week 52 between Q4W vs Placebo."||33.7|-21.8|0.68
72445438|NCT03131648|144406269|SUPERIORITY||Risk Difference (RD)|-9.5||||0.5|TWO_SIDED|95.0|-37.1|18.0||Test not evaluated for significance. Based on the primary analysis of the 'composite' estimand. Subjects who received rescue medication or were transferred to open-label treatment were considered non-responders.|Cochran-Mantel-Haenszel||Mantel-Haenszel risk difference compared to placebo, stratified by region.|"Testing according to the hierarchical testing procedure in the order:~IGA 0/1 at Week 52 between Q2W vs Placebo, EASI75 at Week 52 between Q2W vs Placebo, IGA 0/1 at Week 52 between Q4W vs Placebo, and EASI75 at Week 52 between Q4W vs Placebo."||18.0|-37.1|0.50
72445439|NCT03131648|144406270|SUPERIORITY||Risk Difference (RD)|21.2||||0.056|TWO_SIDED|95.0|-0.2|42.6||Test not evaluated for significance. Based on the primary analysis of the primary estimand 'composite'. Subjects who received rescue medication or were transferred to open-label treatment are considered non-responders.|Cochran-Mantel-Haenszel||Mantel-Haenszel risk difference compared to placebo, stratified by region.|"Testing according to the hierarchical testing procedure in the order:~IGA 0/1 at Week 52 between Q2W vs Placebo, EASI75 at Week 52 between Q2W vs Placebo, IGA 0/1 at Week 52 between Q4W vs Placebo, and EASI75 at Week 52 between Q4W vs Placebo."||42.6|-0.2|0.056
72445440|NCT03131648|144406270|SUPERIORITY||Risk Difference (RD)|11.7||||0.27|TWO_SIDED|95.0|-8.7|32.0||Test not evaluated for significance. Based on the primary analysis of the 'composite' estimand. Subjects who received rescue medication or were transferred to open-label treatment were considered non-responders.|Cochran-Mantel-Haenszel||Mantel-Haenszel risk difference compared to placebo, stratified by region.|"Testing according to the hierarchical testing procedure in the order:~IGA 0/1 at Week 52 between Q2W vs Placebo, EASI75 at Week 52 between Q2W vs Placebo, IGA 0/1 at Week 52 between Q4W vs Placebo, and EASI75 at Week 52 between Q4W vs Placebo."||32.0|-8.7|0.27
72497611|NCT02921425|144525110|OTHER|||||||0.001|||||||t-test, 2 sided|||diastolic blood pressure||||.001
72560747|NCT02959840|144651829|EQUIVALENCE|Our null hypothesis is that there is no statistically significant difference between the number of people who experienced nausea in the above 2 groups.||||||0.7|||||||Chi-squared|||||||0.7
72445441|NCT03131648|144406273|SUPERIORITY|"Based on the primary analysis of the primary estimand 'composite'. Subjects with missing data or subjects who received rescue medication prior to Week 16 were considered non-responders.~The statistical test was not controlled for multiplicity."|Risk Difference (RD)|20.1|||<|0.001|TWO_SIDED|95.0|13.3|26.8|||Cochran-Mantel-Haenszel||Mantel-Haenszel risk difference, stratified by region and disease severity.|||26.8|13.3|<0.001
72445442|NCT03131648|144406274|SUPERIORITY||Risk Difference (RD)|10.3|||<|0.001|TWO_SIDED|95.0|6.4|14.1||"Based on the primary analysis of the primary estimand 'composite'. Subjects with missing data or subjects who received rescue medication prior to Week 16 were considered non-responders.~The statistical test was not controlled for multiplicity."|Cochran-Mantel-Haenszel||Mantel-Haenszel risk difference, stratified by region and disease severity.|||14.1|6.4|<0.001
72445443|NCT03131648|144406275|SUPERIORITY||Difference of least square means|-6.4|||<|0.001|TWO_SIDED|95.0|-8.8|-4.1||The statistical test was not controlled for multiplicity.|Repeated measurements model|||Data collected after permanent discontinuation of IMP or initiation of rescue medication not included. In case of no post-baseline assessments before initiation of rescue medication, the Week 2 change will be imputed as 0.||-4.1|-8.8|<0.001
72445444|NCT03131648|144406276|SUPERIORITY||Risk Difference (RD)|5.7||||0.007|TWO_SIDED|95.0|2.5|8.9||"Based on the primary analysis of the 'composite' estimand. Subjects who received rescue medication prior to Week 16 or with missing data at Week 16 were considered nonresponders.~The statistical test was not controlled for multiplicity."|Cochran-Mantel-Haenszel||Mantel-Haenszel risk difference, stratified by region and baseline disease severity.|||8.9|2.5|0.007
72497612|NCT02921425|144525112|OTHER|||||||0.019|||||||Wilcoxon (Mann-Whitney)|||||||.019
72497613|NCT01227967|144525116|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.0|STANDARD_ERROR_OF_MEAN|5.0||0.046|TWO_SIDED|95.0|-19.8|-0.2||P-value was not adjusted for multiple interim analyses.|Z-test, 2-sided|Comparison of randomized arms was based on the normal approximation to the binomial distribution.|The difference in percents was calculated as the percent detectable in the Combination Therapy minus the percent detectable in the Oseltamivir Monotherapy.|Assuming that pooled percentage of participants with virus detectable by PCR at Day 3 is 50%, assuming that the Combination Therapy was better than the Oseltamivir Monotherapy and that the detectable rate in the Combination Therapy was 42.5% compared to 57.5% in the Oseltamivir Monotherapy (a 15% reduction), and assuming 10% subjects with missing qPCR at Day 3, in a two-sided, two-sample 0.05-level t- test with 546 participants combined across both arms, there was 90% power.||-0.2|-19.8|0.046
72497614|NCT03403400|144525131|EQUIVALENCE|Comparison of variance|Test Statistics|0.893||||0.64|TWO_SIDED||||||Kruskal-Wallis|||Ho: There is no significant difference between groups in mCTSIB Ha: There is a significant difference between groups in mCTSIB||||.640
72560748|NCT02959840|144651829|EQUIVALENCE|Our null hypothesis is that there is no statistically significant difference between the number of people who experienced nausea in the above 2 groups.||||||0.7|||||||Chi-squared|||||||0.7
72560749|NCT02959840|144651829|EQUIVALENCE|Our null hypothesis is that there is no statistically significant difference between the number of people who experienced nausea in the above 2 groups.||||||0.2|||||||Chi-squared|||||||0.2
72445445|NCT03131648|144406277|SUPERIORITY||Risk Difference (RD)|14.1|||<|0.001|TWO_SIDED|95.0|8.6|19.6||"Based on the primary analysis of the 'composite' estimand. Subjects who received rescue medication prior to Week 16 or with missing data at Week 16 were considered non-responders.~The statistical test was not controlled for multiplicity."|Cochran-Mantel-Haenszel||Mantel-Haenszel risk difference stratified by region and disease severity.|||19.6|8.6|<0.001
72445446|NCT03131648|144406278|SUPERIORITY||Difference of least square means|-0.9|||<|0.001|TWO_SIDED|95.0|-1.4|-0.4||The statistical test was not controlled for multiplicity.|Repeated measurements model|||Data collected after permanent discontinuation of IMP or initiation of rescue medication not included. In case of no post-baseline assessments before initiation of rescue medication, the Week 1 change will be imputed as 0.||-0.4|-1.4|<0.001
72445447|NCT03131648|144406279|SUPERIORITY||Risk Difference (RD)|15.2|||<|0.001|TWO_SIDED|95.0|9.2|21.3||"Subjects who received rescue medication prior to Week 16 or have missing data at Week 16 were considered as non-responders.~The statistical test was not controlled for multiplicity."|Cochran-Mantel-Haenszel||Mantel-Haenszel risk difference, stratified by region and baseline disease severity.|||21.3|9.2|<0.001
72445448|NCT03131648|144406280|SUPERIORITY||Risk Difference (RD)|13.0||||0.001|TWO_SIDED|95.0|5.4|20.5||"Subjects who received rescue medication prior to Week 16 or have missing data at Week 16 were considered as non-responders.~The statistical test was not controlled for multiplicity."|Cochran-Mantel-Haenszel||Mantel-Haenszel risk difference, stratified by region and baseline disease severity.|||20.5|5.4|0.001
72445449|NCT02671903|144406282|SUPERIORITY||Fixed Effect for Treatment|0.25||||0.3|TWO_SIDED|95.0|-0.23|0.73|||Mixed Models Analysis|||Change in treatment effect taken from mixed-model output||0.73|-0.23|0.3
72497615|NCT03403400|144525131|EQUIVALENCE|Comparison of variance|Test Statistics|0.196||||0.18|TWO_SIDED||||||Kruskal-Wallis|||Ho: There is no significant difference between the prescribed walking group and the control group in mCTSIB Ha: There is a significant difference between the prescribed walking group and the control group in mCTSIB||||.18
72497616|NCT03403400|144525132|EQUIVALENCE|comparison of variance|Test Statistics|0.803||||0.67|TWO_SIDED||||||Kruskal-Wallis|||Ho: There is no significant difference between the groups in TUG Ha: There is a significant difference between the groups in TUG||||.67
72497617|NCT03403400|144525132|EQUIVALENCE|comparison of variance|Test Statistics|0.14||||0.71|TWO_SIDED||||||Kruskal-Wallis|||Ho: There is no significant difference in TUG between the prescribed walking and control group Ha: There is a significant difference in TUG between the prescribed walking and control group||||.71
72560750|NCT02959840|144651830|EQUIVALENCE|Our null hypothesis is that there is no statistically significant difference between the number of people who experienced nausea in the above 2 groups.||||||1|||||||Chi-squared|||||||1
72445450|NCT03779204|144406323|OTHER||Mean Difference (Final Values)|-2.0||||0.18|TWO_SIDED|95.0|-5.0|1.0|||ANCOVA|||||1.0|-5.0|0.18
72445451|NCT03779204|144406324|OTHER||Mean Difference (Final Values)|-1.4||||0.44|TWO_SIDED|95.0|-5.0|2.3|||ANCOVA|||||2.3|-5.0|0.44
72445452|NCT03779204|144406325|OTHER||Mean Difference (Final Values)|7.3||||0.38|TWO_SIDED|95.0|-9.7|24.4|||ANCOVA|||||24.4|-9.7|.38
72445453|NCT03779204|144406326|OTHER||Mean Difference (Final Values)|0.6||||0.76|TWO_SIDED|95.0|-3.3|4.4|||ANCOVA|||||4.4|-3.3|0.76
72445454|NCT03779204|144406327|OTHER|||||||0.68|||||||ANCOVA|||||||0.68
72497618|NCT03403400|144525133|EQUIVALENCE|Comparison of variance|Test Statistics|0.803|STANDARD_DEVIATION|1.79||0.67|TWO_SIDED||||||Kruskal-Wallis|||Ho: There is no significant difference between the groups in DGI Ha: There is a significant difference between the groups in DGI||||.67
72497619|NCT03403400|144525133|EQUIVALENCE|comparison of variance|Test Statistics|0.66||||0.42|TWO_SIDED||||||Kruskal-Wallis|||Ho: There is no significant difference between the prescribed walking group and the control group in DGI Ha: There is a significant difference between the prescribed walking group and control group in DGI||||.42
72560751|NCT02959840|144651830|EQUIVALENCE|Our null hypothesis is that there is no statistically significant difference between the number of people who experienced nausea in the above 2 groups.||||||0.2|||||||Chi-squared|||||||0.2
72445455|NCT03779204|144406328|OTHER||Mean Difference (Final Values)|-7.2||||0.12|TWO_SIDED|95.0|-16.4|2.0|||ANCOVA|||||2.0|-16.4|0.12
72497620|NCT03403400|144525134|EQUIVALENCE|comparison of variance|Test Statistics|4.386||||0.11|TWO_SIDED||||||Kruskal-Wallis|||Ho: There is no significant difference between the groups in DHI Ha: There is a significant difference between the groups in DHI||||.11
72497621|NCT03403400|144525134|EQUIVALENCE|comparison of variance|Test Statistics|4.351||||0.04|TWO_SIDED||||||Kruskal-Wallis|||Ho: There is no significant difference in DHI between the prescribed walking group and the control group Ha: There is a significant difference in DHI between the prescribed walking group and the control group||||.04
72560752|NCT02959840|144651830|EQUIVALENCE|Our null hypothesis is that there is no statistically significant difference between the number of people who experienced nausea in the above 2 groups.||||||0.1|||||||Chi-squared|||||||0.1
72445456|NCT03779204|144406329|OTHER||Mean Difference (Final Values)|-4.4||||0.34|TWO_SIDED|95.0|-13.7|5.0|||ANCOVA|||||5.0|-13.7|0.34
72445457|NCT03779204|144406331|OTHER||Mean Difference (Final Values)|-1.3||||0.62|TWO_SIDED|95.0|-6.6|4.0|||ANCOVA|||||4.0|-6.6|0.62
72445458|NCT04258709|144406334|SUPERIORITY|||||||0.12|||||||Chi-squared|||||||.1200
72445459|NCT04258709|144406334|SUPERIORITY||Odds Ratio (OR)|0.593||||0.0474|TWO_SIDED|95.0|0.352|0.9907|||Regression, Logistic||Adjusted for race, Iowa Infant Feeding Attitudes Score at baseline, infant gestational age, NICU admission, maternal age at enrollment, WIC enrollment at baseline, maternal pre-pregnancy BMI. This is an adjusted odds ratio.|||.9907|.352|.0474
72445460|NCT04258709|144406335|SUPERIORITY|||||||0.5201|||||||t-test, 1 sided|||||||.5201
72445461|NCT04258709|144406335|SUPERIORITY||Slope|0.1399||||0.9178|TWO_SIDED|95.0|-2.5299|2.8098|||Regression, Linear|||||2.8098|-2.5299|.9178
72445462|NCT04258709|144406336|SUPERIORITY|||||||0.8614|||||||t-test, 1 sided|||||||.8614
72445463|NCT04258709|144406336|SUPERIORITY||Odds Ratio (OR)|1.0763||||0.7836|TWO_SIDED|95.0|0.6364|1.8216|||Regression, Logistic|||||1.8216|.6364|.7836
72445464|NCT04258709|144406337|SUPERIORITY|||||||0.9788|||||||Chi-squared|||||||.9788
72445465|NCT04258709|144406337|SUPERIORITY||Odds Ratio (OR)|1.0307||||0.9119|TWO_SIDED|95.0|0.603|1.7067|||Regression, Logistic|||||1.7067|.603|.9119
72445466|NCT04258709|144406338|SUPERIORITY||Odds Ratio (OR)|0.7157||||0.2173|TWO_SIDED|95.0|0.4192|1.216|||Regression, Logistic|||||1.216|.4192|.2173
72445467|NCT04258709|144406339|SUPERIORITY||Odds Ratio (OR)|0.7157||||0.5209|TWO_SIDED|95.0|0.4192|1.216|||Regression, Logistic|||||1.216|.4192|.5209
72445468|NCT04258709|144406342|SUPERIORITY|||||||0.4258|||||||Chi-squared|||||||.4258
72445469|NCT04258709|144406342|SUPERIORITY||Odds Ratio (OR)|0.8882||||0.6246|TWO_SIDED|95.0|0.5523|1.4283|||Regression, Logistic|||||1.4283|.5523|.6246
72445470|NCT04258709|144406343|SUPERIORITY|||||||0.5613|||||||Chi-squared|||||||.5613
72445471|NCT04258709|144406343|SUPERIORITY||Odds Ratio (OR)|0.7157||||0.2173|TWO_SIDED|95.0|0.4206|1.2178|||Regression, Logistic|||||1.2178|.4206|.2173
72445472|NCT04258709|144406344|SUPERIORITY|||||||0.6291|||||||Chi-squared|||||||.6291
72445473|NCT04258709|144406344|SUPERIORITY||Odds Ratio (OR)|1.1955||||0.5426|TWO_SIDED|95.0|0.8745|1.3931|||Regression, Logistic|||||1.3931|.8745|.5426
72445474|NCT04258709|144406345|SUPERIORITY|||||||0.9071|||||||Chi-squared|||||||.9071
72445475|NCT04258709|144406345|SUPERIORITY||Odds Ratio (OR)|1.0233||||0.9328|TWO_SIDED|95.0|0.7751|1.2084|||Regression, Logistic|||||1.2084|.7751|.9328
72445476|NCT04258709|144406346|SUPERIORITY||Slope|0.8213||||0.5548|TWO_SIDED|95.0|-1.9161|3.5588|||Regression, Linear|||||3.5588|-1.9161|.5548
72445477|NCT04258709|144406347|SUPERIORITY||Slope|1.2412||||0.3861|TWO_SIDED|95.0|-1.5771|4.0594|||Regression, Linear|||||4.0594|-1.5771|.3861
72445478|NCT04258709|144406348|SUPERIORITY|||||||0.4779|||||||t-test, 1 sided|||||||.4779
72445479|NCT04258709|144406349|SUPERIORITY|||||||1|||||||Chi-squared|||||||1
72445480|NCT04258709|144406349|SUPERIORITY||Odds Ratio (OR)|0.9508||||0.9163|TWO_SIDED|95.0|0.3669|2.4621|||Regression, Logistic|||||2.4621|.3669|.9163
72445481|NCT04258709|144406350|SUPERIORITY||Odds Ratio (OR)|1.1084||||0.8031|TWO_SIDED|95.0|0.4937|2.4882|||Regression, Logistic|||||2.4882|.4937|.8031
72445482|NCT04258709|144406351|SUPERIORITY||Odds Ratio (OR)|1.1346||||0.8175|TWO_SIDED|95.0|0.3882|3.3161|||Regression, Logistic|||||3.3161|.3882|.8175
72497622|NCT01763164|144525138|SUPERIORITY||Hazard Ratio (HR)|0.62|||<|0.001|TWO_SIDED|95.0|0.47|0.8|||Log Rank|||Hazard ratio was obtained from the stratified unadjusted Cox model. P-value was obtained from the one-sided stratified log-rank test.||0.80|0.47|< 0.001
72445483|NCT04258709|144406352|SUPERIORITY||Odds Ratio (OR)|0.6964||||0.434|TWO_SIDED|95.0|0.2813|1.7241|||Regression, Logistic|||||1.7241|.2813|.434
72445484|NCT04258709|144406353|SUPERIORITY||Odds Ratio (OR)|1.2533||||0.4968|TWO_SIDED|95.0|0.6534|2.4041|||Regression, Logistic|||||2.4041|.6534|.4968
72445485|NCT04258709|144406354|SUPERIORITY||Odds Ratio (OR)|1.0288||||0.9005|TWO_SIDED|95.0|0.659|1.6062|||Regression, Logistic|||||1.6062|.659|.9005
72445486|NCT04258709|144406355|SUPERIORITY||Slope|-1.4018||||0.127|TWO_SIDED|95.0|-3.2052|0.4015|||Regression, Linear|||||.4015|-3.2052|.127
72445487|NCT04258709|144406356|SUPERIORITY||Slope|-1.8958||||0.07|TWO_SIDED|95.0|-3.9475|0.1559|||Regression, Linear|||||.1559|-3.9475|.07
72445488|NCT04258709|144406357|SUPERIORITY||Slope|-0.506||||0.6299|TWO_SIDED|95.0|-2.574|1.562|||Regression, Linear|||||1.562|-2.574|.6299
72445489|NCT04258709|144406358|SUPERIORITY||Odds Ratio (OR)|0.7573||||0.3835|TWO_SIDED|95.0|0.4029|1.4138|||Regression, Logistic|||||1.4138|.4029|.3835
72445490|NCT04258709|144406359|SUPERIORITY||Odds Ratio (OR)|0.784||||0.459|TWO_SIDED|95.0|0.409|1.4912|||Regression, Logistic|||||1.4912|.409|.459
72445491|NCT04258709|144406360|SUPERIORITY||Odds Ratio (OR)|0.9338||||0.8499|TWO_SIDED|95.0|0.458|1.9039|||Regression, Logistic|||||1.9039|.458|.8499
72445492|NCT03420833|144406391|SUPERIORITY|||||||0.0001|||||||t-test, 2 sided|||||||0.0001
72445493|NCT03420833|144406391|SUPERIORITY|||||||0.009|||||||t-test, 2 sided|||||||0.009
72445494|NCT03420833|144406394|SUPERIORITY|||||||0.024|||||||t-test, 2 sided|||||||0.024
72445495|NCT03420833|144406396|SUPERIORITY|||||||0.0001|||||||t-test, 2 sided|||||||0.0001
72445496|NCT03420833|144406396|SUPERIORITY|||||||0.011|||||||t-test, 2 sided|||||||0.011
72445497|NCT03336333|144406412|SUPERIORITY||Hazard Ratio (HR)|0.42|||<|0.0001|TWO_SIDED|95.0|0.28|0.63||One-sided|Log Rank|||||0.63|0.28|<0.0001
72445498|NCT02120456|144406492|SUPERIORITY||Rate ratio|0.45|||<|0.001|TWO_SIDED|95.0|0.34|0.58|||Negative binominal regression|||Negative binominal regression with log baseline count as offset variable and treatment group and analysis site as factors.||0.58|0.34|<0.001
72445499|NCT02120456|144406492|SUPERIORITY||Rate ratio|0.56|||<|0.001|TWO_SIDED|95.0|0.44|0.73|||Negative binominal regression|||Negative binominal regression with log baseline count as offset variable and treatment group and analysis site as factors.||0.73|0.44|<0.001
72445500|NCT02120456|144406492|SUPERIORITY||Rate ratio|1.26||||0.058|TWO_SIDED|95.0|0.99|1.6|||Negative binominal regression|||||1.60|0.99|0.058
72445501|NCT02120456|144406493|SUPERIORITY||Ratio of clearance rates|1.05||||0.94|TWO_SIDED|95.0|0.3|4.73|||Log binomial regression|||Log binomial regression with factors treatment group and baseline AK count as a covariate.||4.73|0.30|0.94
72445502|NCT02120456|144406493|SUPERIORITY||Ratio of clearance rates|1.0||||1|TWO_SIDED|95.0|0.28|4.51|||Log binomial regression|||Log binomial regression with factors treatment group and baseline AK count as a covariate.||4.51|0.28|1.00
72445503|NCT02120456|144406493|SUPERIORITY||Ratio of clearance rates|0.95||||0.93|TWO_SIDED|95.0|0.31|2.89|||Log binomial regression|||Log binomial regression with factors treatment group and baseline AK count as a covariate.||2.89|0.31|0.93
72445504|NCT02120456|144406494|SUPERIORITY||Ratio of clearance rates|2.88||||0.003|TWO_SIDED|95.0|1.36|7.85|||Log binomial regression|||Log binomial regression with factors treatment group and baseline AK count as a covariate.||7.85|1.36|0.003
72445505|NCT02120456|144406494|SUPERIORITY||Ratio of clearance rates|2.84||||0.004|TWO_SIDED|95.0|1.35|7.74|||Log binomial regression|||Log binomial regression with factors treatment group and baseline AK count as a covariate.||7.74|1.35|0.004
72445506|NCT02120456|144406494|SUPERIORITY||Ratio of clearance rates|0.99||||0.95|TWO_SIDED|95.0|0.66|1.47|||Log binomial regression|||Log binomial regression with factors treatment group and baseline AK count as a covariate.||1.47|0.66|0.95
72445507|NCT02243709|144406517|OTHER||||||>|0.05|||||||Chi-squared|||||||>.05
72445508|NCT03378570|144406520|OTHER|comparative effectiveness trial||||||0.945|||||||t-test, 2 sided|||The null hypothesis of this study was that there would be no differences between targets across all measures.||||0.945
72445509|NCT03378570|144406521|OTHER|comparative effectiveness trial||||||0.828|||||||t-test, 2 sided|||The null hypothesis of this study was that there would be no differences between targets across all measures.||||0.828
72445510|NCT03378570|144406522|OTHER|comparative effectiveness trial||||||0.252|||||||t-test, 2 sided|||The null hypothesis of this study was that there would be no differences between targets across all measures.||||0.252
72445511|NCT03378570|144406523|OTHER|||||||0.505||||||p value for response rate|Chi-squared|||"The null hypothesis of this study was that there would be no differences between targets across all measures.~A power analysis revealed that a total sample size of 144 would have 80% power when testing for differences between target groups at alpha = 0.05. Accounting for potential attrition, the study conservatively planned to enroll 200 participants, with a planned interim analysis after 100 participants were randomized."||||0.505
72445512|NCT03378570|144406523|OTHER|||||||0.888||||||p value for remission rate|Chi-squared|||"The null hypothesis of this study was that there would be no differences between targets across all measures.~A power analysis revealed that a total sample size of 144 would have 80% power when testing for differences between target groups at alpha = 0.05. Accounting for potential attrition, the study conservatively planned to enroll 200 participants, with a planned interim analysis after 100 participants were randomized."||||0.888
72445513|NCT03378570|144406524|OTHER|||||||0.994|||||||Chi-squared|p value for response rates||"The null hypothesis of this study was that there would be no differences between targets across all measures.~A power analysis revealed that a total sample size of 144 would have 80% power when testing for differences between target groups at alpha = 0.05. Accounting for potential attrition, the study conservatively planned to enroll 200 participants, with a planned interim analysis after 100 participants were randomized."||||0.994
72445514|NCT03378570|144406524|OTHER|||||||0.911|||||||Chi-squared|p value for remission rates||"The null hypothesis of this study was that there would be no differences between targets across all measures.~A power analysis revealed that a total sample size of 144 would have 80% power when testing for differences between target groups at alpha = 0.05. Accounting for potential attrition, the study conservatively planned to enroll 200 participants, with a planned interim analysis after 100 participants were randomized."||||0.911
72445515|NCT03378570|144406525|OTHER|||||||0.778|||||||t-test, 2 sided|||"The null hypothesis of this study was that there would be no differences between targets across all measures.~A power analysis revealed that a total sample size of 144 would have 80% power when testing for differences between target groups at alpha = 0.05. Accounting for potential attrition, the study conservatively planned to enroll 200 participants, with a planned interim analysis after 100 participants were randomized."||||0.778
72445516|NCT03378570|144406526|OTHER|comparative effectiveness trial||||||0.951|||||||t-test, 2 sided|||The null hypothesis of this study was that there would be no differences between targets across all measures.||||.951
72445517|NCT03378570|144406527|OTHER|comparative effectiveness trial||||||0.278|||||||t-test, 2 sided|||The null hypothesis of this study was that there would be no differences between targets across all measures. Results below are for the subscale, Positive Affect.||||.278
72445518|NCT03378570|144406527|OTHER|comparative effectiveness trial||||||0.024|||||||t-test, 2 sided|||The null hypothesis of this study was that there would be no differences between targets across all measures. Results below are for the subscale, General Life Satisfaction.||||.024
72445519|NCT03378570|144406527|OTHER|comparative effectiveness trial||||||0.439|||||||t-test, 2 sided|||The null hypothesis of this study was that there would be no differences between targets across all measures. Results below are for the subscale, Meaning \& Purpose.||||.439
72445520|NCT03378570|144406527|OTHER|comparative effectiveness trial||||||0.025|||||||t-test, 2 sided|||The null hypothesis of this study was that there would be no differences between targets across all measures. Results below are for the subscale, Emotional Support.||||.025
72445521|NCT03378570|144406527|OTHER|comparative effectiveness trial||||||0.007|||||||t-test, 2 sided|||The null hypothesis of this study was that there would be no differences between targets across all measures. Results below are for the subscale, Instrumental Support.||||.007
72445522|NCT03378570|144406527|OTHER|comparative effectiveness trial||||||0.014|||||||t-test, 2 sided|||The null hypothesis of this study was that there would be no differences between targets across all measures. Results below are for the subscale, Friendship.||||.014
72445523|NCT03378570|144406527|OTHER|comparative effectiveness trial||||||0.398|||||||t-test, 2 sided|||The null hypothesis of this study was that there would be no differences between targets across all measures. Results below are for the subscale, Loneliness.||||.398
72445524|NCT03378570|144406527|OTHER|comparative effectiveness trial||||||0.064|||||||t-test, 2 sided|||The null hypothesis of this study was that there would be no differences between targets across all measures. Results below are for the subscale, Perceived Rejection.||||.064
72445525|NCT03378570|144406527|OTHER|comparative effectiveness trial||||||0.368|||||||t-test, 2 sided|||The null hypothesis of this study was that there would be no differences between targets across all measures. Results below are for the subscale, Perceived Hostility.||||.368
72445526|NCT03378570|144406527|OTHER|comparative effectiveness trial||||||0.504|||||||t-test, 2 sided|||The null hypothesis of this study was that there would be no differences between targets across all measures. Results below are for the subscale, Self-Efficacy.||||.504
72445527|NCT03378570|144406527|OTHER|comparative effectiveness trial||||||0.371|||||||t-test, 2 sided|||The null hypothesis of this study was that there would be no differences between targets across all measures. Results below are for the subscale, Perceived Stress.||||.371
72445528|NCT03378570|144406527|OTHER|comparative effectiveness trial||||||0.438|||||||t-test, 2 sided|||The null hypothesis of this study was that there would be no differences between targets across all measures. Results below are for the subscale, Fear-Affect.||||.438
72445529|NCT03378570|144406527|OTHER|comparative effectiveness trial||||||0.096|||||||t-test, 2 sided|||The null hypothesis of this study was that there would be no differences between targets across all measures. Results below are for the subscale, Fear-Somatic Arousal.||||.096
72445530|NCT03378570|144406527|OTHER|comparative effectiveness trial||||||0.132|||||||t-test, 2 sided|||The null hypothesis of this study was that there would be no differences between targets across all measures. Results below are for the subscale, Sadness.||||.132
72445531|NCT03378570|144406527|OTHER|comparative effectiveness trial||||||0.951|||||||t-test, 2 sided|||The null hypothesis of this study was that there would be no differences between targets across all measures. Results below are for the subscale, Anger-Affect.||||.951
72445532|NCT03378570|144406527|OTHER|comparative effectiveness trial||||||0.852|||||||t-test, 2 sided|||The null hypothesis of this study was that there would be no differences between targets across all measures. Results below are for the subscale, Anger-Hostility.||||.852
72445533|NCT03378570|144406527|OTHER|comparative effectiveness trial||||||0.083|||||||t-test, 2 sided|||The null hypothesis of this study was that there would be no differences between targets across all measures. Results below are for the subscale, Anger-Physical Aggression.||||.083
72445534|NCT03378570|144406527|OTHER|comparative effectiveness trial||||||0.391|||||||t-test, 2 sided|||The null hypothesis of this study was that there would be no differences between targets across all measures. Results below are for the subscale, Negative Affect.||||.391
72445535|NCT03378570|144406527|OTHER|comparative effectiveness trial||||||0.014|||||||t-test, 2 sided|||The null hypothesis of this study was that there would be no differences between targets across all measures. Results below are for the subscale, Social Satisfaction.||||.014
72445536|NCT03378570|144406527|OTHER|comparative effectiveness trial||||||0.109|||||||t-test, 2 sided|||The null hypothesis of this study was that there would be no differences between targets across all measures. Results below are for the subscale, Psychological Well Being.||||.109
72445537|NCT03378570|144406528|SUPERIORITY|||||||0.231||||||Week 6 timepoint p-value listed above|Mixed Models Analysis|"Other timepoint p-values below:~First Visit p = 0.875 Week 1 p = 0.084 Week 2 p = 0.277 Week 3 p = 0.686 Week 4 p = 0.369 Week 5 p = 0.806"||||||0.231
72445538|NCT03378570|144406529|SUPERIORITY|||||||0.963||||||Week 6-7 Follow-up p-value listed above|Mixed Models Analysis|"Other timepoint p-values below:~Evaluation p = 0.570 Week 2-3 Follow-up p = 0.063 Week 4-5 Follow-up p = 0.792"||||||0.963
72445539|NCT03378570|144406530|SUPERIORITY|||||||0.051||||||Week 6 timepoint p-value listed above|Mixed Models Analysis|"Other timepoint p-values below:~First Visit p = 0.772 Week 1 p = 0.194 Week 2 p = 0.127 Week 3 p = 0.196 Week 4 p = 0.079 Week 5 p = 0.187"||||||0.051
72445540|NCT04169373|144406548|SUPERIORITY|To preserve the overall type I error rate at α = 0.05 level, a multiple testing procedure was used to test the primary and multiplicity-controlled secondary endpoints. Testing began with the primary endpoint using two-sided α = 0.05; significance could be claimed for a lower ranked endpoint only if the previous endpoints in the sequence met the requirement of significance.|Response Rate Difference|26.4|||<|0.0001|TWO_SIDED|95.0|17.9|34.9|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) model adjusted by main stratification factor of screening hsCRP level (\> ULN vs ≤ ULN).|Response Rate Difference = Upadacitinib - Placebo|Efficacy analyses and hypothesis testing including multiplicity adjustment were performed independently for Study 1 and Study 2.||34.9|17.9|<0.0001
72445541|NCT04169373|144406549|SUPERIORITY|To preserve the overall type I error rate at α = 0.05 level, a multiple testing procedure was used to test the primary and multiplicity-controlled secondary endpoints. Testing began with the primary endpoint using two-sided α = 0.05; significance could be claimed for a lower ranked endpoint only if the previous endpoints in the sequence met the requirement of significance.|Response Rate Difference|22.2|||<|0.0001|TWO_SIDED|95.0|12.1|32.3|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by main stratification factor of MRI and screening hsCRP status.|Response Rate Difference = Upadacitinib - Placebo|"Efficacy analyses and hypothesis testing including multiplicity adjustment were performed independently for Study 1 and Study 2.~Binary endpoints in Study 2 were analyzed using the Cochran-Mantel-Haenszel (CMH) test stratified by the main stratification factor of positivity for MRI inflammation in the sacroiliac joints and screening hsCRP status (MRI-positive and hsCRP \> ULN vs MRI-positive and hsCRP ≤ ULN vs MRI-negative and hsCRP \> ULN)."||32.3|12.1|<0.0001
72445542|NCT04169373|144406549|OTHER||Odds Ratio (OR)|2.8|||||TWO_SIDED|95.0|1.7|4.5|||||Upadacitinib : Placebo|A post-hoc logistic regression adjusting for the main stratification factor of MRI and screening hsCRP status was conducted for the multiplicity-controlled binary endpoints assessed at Week 14.||4.5|1.7|
72445543|NCT04169373|144406550|SUPERIORITY|To preserve the overall type I error rate at α=0.05 level, a multiple testing procedure was used to test the primary and multiplicity-controlled secondary endpoints. Testing began with the primary endpoint using two-sided α = 0.05; significance could be claimed for a lower ranked endpoint only if the previous endpoints in the sequence met the requirement of significance.|Least Squares (LS) Mean Difference|-1.02|||<|0.0001|TWO_SIDED|95.0|-1.2|-0.85|||Mixed-effect Model Repeated Measurement|MMRM model includes treatment, visit and treatment-by-visit interaction, screening hsCRP level (\> ULN vs ≤ ULN) and Baseline value as covariate.|Treatment difference = Upadacitinib - Placebo|||-0.85|-1.20|<0.0001
72445544|NCT04169373|144406551|SUPERIORITY|To preserve the overall type I error rate at α=0.05 level, a multiple testing procedure was used to test the primary and multiplicity-controlled secondary endpoints. Testing began with the primary endpoint using two-sided α = 0.05; significance could be claimed for a lower ranked endpoint only if the previous endpoints in the sequence met the requirement of significance.|LS Mean Difference|-3.9|||<|0.0001|TWO_SIDED|95.0|-5.47|-2.33|||ANCOVA|ANCOVA model including treatment and screening hsCRP level as fixed factors and Baseline value as covariate.|Treatment difference = Upadacitinib - Placebo|||-2.33|-5.47|<0.0001
72445545|NCT04169373|144406552|SUPERIORITY|To preserve the overall type I error rate at α=0.05 level, a multiple testing procedure was used to test the primary and multiplicity-controlled secondary endpoints. Testing began with the primary endpoint using two-sided α = 0.05; significance could be claimed for a lower ranked endpoint only if the previous endpoints in the sequence met the requirement of significance.|Response Rate Difference|26.4|||<|0.0001|TWO_SIDED|95.0|18.0|34.8|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) model adjusted by main stratification factor of screening hsCRP level (\> ULN vs ≤ ULN).|Response Rate Difference = Upadacitinib - Placebo|||34.8|18.0|<0.0001
72445546|NCT04169373|144406553|SUPERIORITY|To preserve the overall type I error rate at α = 0.05 level, a multiple testing procedure was used to test the primary and multiplicity-controlled secondary endpoints. Testing began with the primary endpoint using two-sided α = 0.05; significance could be claimed for a lower ranked endpoint only if the previous endpoints in the sequence met the requirement of significance.|Response Rate Difference|27.1|||<|0.0001|TWO_SIDED|95.0|17.9|36.3|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) model adjusted by main stratification factor of screening hsCRP level (\> ULN vs ≤ ULN).|Response Rate Difference = Upadacitinib - Placebo|||36.3|17.9|<0.0001
72497623|NCT01763164|144525139|SUPERIORITY||Hazard Ratio (HR)|1.0||||0.499|TWO_SIDED|95.0|0.75|1.33|||Log Rank|||Hazard ratio was obtained from the stratified unadjusted Cox model. P-value was obtained from the one-sided stratified log rank test.||1.33|0.75|0.499
72497624|NCT01763164|144525140|SUPERIORITY|||||||0.015|||||||Cochran-Mantel-Haenszel|||Confirmed ORR: The p-value (2-sided) was computed from stratified Cochran-Mantel-Haenszel chi-square test statistic.||||0.015
72497625|NCT01763164|144525140|SUPERIORITY|||||||0.002|||||||Cochran-Mantel-Haenszel|||Confirmed ORR + Unconfirmed ORR: The p-value (2-sided) was computed from stratified Cochran-Mantel-Haenszel chi-square test statistic.||||0.002
72497626|NCT01763164|144525153|SUPERIORITY||Hazard Ratio (HR)|1.43|||||TWO_SIDED|95.0|0.96|2.13|||Log Rank|||||2.13|0.96|
72497627|NCT01763164|144525156|SUPERIORITY||Hazard Ratio (HR)|2.2||||0.995|TWO_SIDED|95.0|1.19|4.06|||Log Rank|||Log-rank test and Cox PH model were stratified by American joint committee on cancer stage, prior line immunotherapy and ECOG performance status. P-value was one tailed and was based on the log-rank score test. Hazard ratio and 95% CI was based on a Wald test from Cox model.||4.06|1.19|0.995
72445547|NCT04169373|144406554|SUPERIORITY|To preserve the overall type I error rate at α = 0.05 level, a multiple testing procedure was used to test the primary and multiplicity-controlled secondary endpoints. Testing began with the primary endpoint using two-sided α = 0.05; significance could be claimed for a lower ranked endpoint only if the previous endpoints in the sequence met the requirement of significance.|Response Rate Difference|10.9|||<|0.0001|TWO_SIDED|95.0|6.0|15.8|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) model adjusted by main stratification factor of screening hsCRP level (\> ULN vs ≤ ULN).|Response Rate Difference = Upadacitinib - Placebo|||15.8|6.0|<0.0001
72445548|NCT04169373|144406555|SUPERIORITY|To preserve the overall type I error rate at α=0.05 level, a multiple testing procedure was used to test the primary and multiplicity-controlled secondary endpoints. Testing began with the primary endpoint using two-sided α = 0.05; significance could be claimed for a lower ranked endpoint only if the previous endpoints in the sequence met the requirement of significance.|LS Mean Difference|-1.53|||<|0.0001|TWO_SIDED|95.0|-1.96|-1.11|||Mixed-effect Model Repeated Measurement|MMRM model includes treatment, visit and treatment-by-visit interaction, screening hsCRP level (\> ULN vs ≤ ULN) and Baseline value as covariate.|Treatment difference = Upadacitinib - Placebo|||-1.11|-1.96|<0.0001
72445549|NCT04169373|144406556|SUPERIORITY|To preserve the overall type I error rate at α=0.05 level, a multiple testing procedure was used to test the primary and multiplicity-controlled secondary endpoints. Testing began with the primary endpoint using two-sided α = 0.05; significance could be claimed for a lower ranked endpoint only if the previous endpoints in the sequence met the requirement of significance.|LS Mean Difference|-1.69|||<|0.0001|TWO_SIDED|95.0|-2.14|-1.24|||Mixed-effect Model Repeated Measurement|MMRM model includes treatment, visit and treatment-by-visit interaction, screening hsCRP level (\> ULN vs ≤ ULN) and Baseline value as covariate.|Treatment difference = Upadacitinib - Placebo|||-1.24|-2.14|<0.0001
72445550|NCT04169373|144406557|SUPERIORITY|To preserve the overall type I error rate at α=0.05 level, a multiple testing procedure was used to test the primary and multiplicity-controlled secondary endpoints. Testing began with the primary endpoint using two-sided α = 0.05; significance could be claimed for a lower ranked endpoint only if the previous endpoints in the sequence met the requirement of significance.|Response Rate Difference|34.0|||<|0.0001|TWO_SIDED|95.0|26.2|41.8|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) model adjusted by main stratification factor of screening hsCRP level (\> ULN vs ≤ ULN).|Response Rate Difference = Upadacitinib - Placebo|||41.8|26.2|<0.0001
72445551|NCT04169373|144406558|SUPERIORITY|To preserve the overall type I error rate at α=0.05 level, a multiple testing procedure was used to test the primary and multiplicity-controlled secondary endpoints. Testing began with the primary endpoint using two-sided α = 0.05; significance could be claimed for a lower ranked endpoint only if the previous endpoints in the sequence met the requirement of significance.|LS Mean Difference|-1.17|||<|0.0001|TWO_SIDED|95.0|-1.55|-0.8|||Mixed-effect Model Repeated Measurement|MMRM model includes treatment, visit and treatment-by-visit interaction, screening hsCRP level (\> ULN vs ≤ ULN) and Baseline value as covariate.|Treatment difference = Upadacitinib - Placebo|||-0.80|-1.55|<0.0001
72445552|NCT04169373|144406559|SUPERIORITY|To preserve the overall type I error rate at α=0.05 level, a multiple testing procedure was used to test the primary and multiplicity-controlled secondary endpoints. Testing began with the primary endpoint using two-sided α = 0.05; significance could be claimed for a lower ranked endpoint only if the previous endpoints in the sequence met the requirement of significance.|Response Rate Difference|13.2|||<|0.0001|TWO_SIDED|95.0|7.4|19.0|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) model adjusted by main stratification factor of screening hsCRP level (\> ULN vs ≤ ULN).|Response Rate Difference = Upadacitinib - Placebo|||19.0|7.4|<0.0001
72445553|NCT04169373|144406560|SUPERIORITY|To preserve the overall type I error rate at α=0.05 level, a multiple testing procedure was used to test the primary and multiplicity-controlled secondary endpoints. Testing began with the primary endpoint using two-sided α = 0.05; significance could be claimed for a lower ranked endpoint only if the previous endpoints in the sequence met the requirement of significance.|LS Mean Difference|-3.07|||<|0.0001|TWO_SIDED|95.0|-3.9|-2.24|||Mixed-effect Model Repeated Measurement|MMRM model includes treatment, visit and treatment-by-visit interaction, screening hsCRP level (\> ULN vs ≤ ULN) and Baseline value as covariate.|Treatment difference = Upadacitinib - Placebo|||-2.24|-3.90|<0.0001
72445554|NCT04169373|144406561|SUPERIORITY|To preserve the overall type I error rate at α=0.05 level, a multiple testing procedure was used to test the primary and multiplicity-controlled secondary endpoints. Testing began with the primary endpoint using two-sided α = 0.05; significance could be claimed for a lower ranked endpoint only if the previous endpoints in the sequence met the requirement of significance.|LS Mean Difference|-1.85|||<|0.0001|TWO_SIDED|95.0|-2.47|-1.24|||Mixed-effect Model Repeated Measurement|MMRM model includes treatment, visit and treatment-by-visit interaction, screening hsCRP level (\> ULN vs ≤ ULN) and Baseline value as covariate.|Treatment difference = Upadacitinib - Placebo|||-1.24|-2.47|<0.0001
72497628|NCT01512264|144525178|OTHER|||||||0.006|||||||t-test, 2 sided|||paired t- test between time point 1 and time point 4 for the rTMS group and BNT test was calculated. Cohen's d was calculated to determine the power of the test. The Cohen's d calculated for this test = -1.58.||||0.006
72497629|NCT01512264|144525178|OTHER|||||||0.015|||||||t-test, 2 sided|||paired t- test between time point 1 and time point 4 for the1 week of Sham Treatment + 2 weeks of nerTMS group and BNT test was calculated. Cohen's d was calculated to determine the power of the test. The Cohen's d calculated for this test = -1.27.||||0.015
72497630|NCT01512264|144525178|OTHER|||||||0.203|||||||t-test, 2 sided|||paired t- test between time point 1 and time point 4 for the 2 weeks of Sham Treatment + 1 week of nerTMS group and BNT test was calculated. Cohen's d was calculated to determine the power of the test. The Cohen's d calculated for this test = -0.54.||||0.203
72497631|NCT01512264|144525178|OTHER|||||||0.01|||||||t-test, 2 sided|||paired t- test between time point 1 and time point 4 for the control group and BNT test were calculated. Cohen's d was calculated to determine the power of the test. The Cohen's d calculated for this test = -1.63.||||0.010
72560753|NCT02959840|144651831|EQUIVALENCE|Our null hypothesis is that there is no statistically significant difference between the number of people who experienced vomiting in the above 2 groups.||||||0.001|||||||Chi-squared|||||||0.001
72619286|NCT01654250|144769241|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.5|STANDARD_ERROR_OF_MEAN|0.56|<|0.001|TWO_SIDED|95.0|-3.6|-1.4|||Mixed Models Analysis|||Hour 2 post-dose attention subscale: Treatment comparisons for observed scores were assessed using a mixed model repeated measures analysis, with treatment (NWP09/Placebo), study center, time point and time point by treatment interaction as main effects and participant intercept as a random effect.||-1.4|-3.6|<0.001
72619287|NCT01654250|144769241|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.3|STANDARD_ERROR_OF_MEAN|0.56|<|0.001|TWO_SIDED|95.0|-3.4|-1.2|||Mixed Models Analysis|||Hour 4 post-dose attention subscale: Treatment comparisons for observed scores were assessed using a mixed model repeated measures analysis, with treatment (NWP09/Placebo), study center, time point and time point by treatment interaction as main effects and participant intercept as a random effect.||-1.2|-3.4|<0.001
72619288|NCT01654250|144769241|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.7|STANDARD_ERROR_OF_MEAN|0.56||0.003|TWO_SIDED|95.0|-2.8|-0.6|||Mixed Models Analysis|||Hour 8 post-dose attention subscale: Treatment comparisons for observed scores were assessed using a mixed model repeated measures analysis, with treatment (NWP09/Placebo), study center, time point and time point by treatment interaction as main effects and participant intercept as a random effect.||-0.6|-2.8|0.003
72619289|NCT01654250|144769241|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|0.56||0.097|TWO_SIDED|95.0|-2.0|0.2|||Mixed Models Analysis|||Hour 10 post-dose attention subscale: Treatment comparisons for observed scores were assessed using a mixed model repeated measures analysis, with treatment (NWP09/Placebo), study center, time point and time point by treatment interaction as main effects and participant intercept as a random effect.||0.2|-2.0|0.097
72619290|NCT01654250|144769241|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.56||0.49|TWO_SIDED|95.0|-1.5|0.7|||Mixed Models Analysis|||Hour 12 post-dose attention subscale: Treatment comparisons for observed scores were assessed using a mixed model repeated measures analysis, with treatment (NWP09/Placebo), study center, time point and time point by treatment interaction as main effects and participant intercept as a random effect.||0.7|-1.5|0.490
72619291|NCT01654250|144769241|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.56||0.164|TWO_SIDED|95.0|-1.9|0.3|||Mixed Models Analysis|||Hour 13 post-dose attention subscale: Treatment comparisons for observed scores were assessed using a mixed model repeated measures analysis, with treatment (NWP09/Placebo), study center, time point and time point by treatment interaction as main effects and participant intercept as a random effect.||0.3|-1.9|0.164
72497632|NCT01512264|144525179|OTHER|||||||0.41|||||||t-test, 2 sided|||paired t- test between time point 1 and time point 5 for the rTMS group and BNT test was calculated. Cohen's d was calculated to determine the power of the test. The Cohen's d calculated for this test = -0.54.||||0.410
72560754|NCT02959840|144651831|EQUIVALENCE|Our null hypothesis is that there is no statistically significant difference between the number of people who experienced vomiting in the above 2 groups.||||||0.0004|||||||Chi-squared|||||||0.0004
72560755|NCT02959840|144651831|EQUIVALENCE|Our null hypothesis is that there is no statistically significant difference between the number of people who experienced vomiting in the above 2 groups.||||||1|||||||Chi-squared|||||||1
72560756|NCT02959840|144651832|EQUIVALENCE|Our null hypothesis is that there is no statistically significant difference between the number of people who experienced vomiting in the above 2 groups.||||||0.008|||||||Chi-squared|||||||0.008
72560757|NCT02959840|144651832|EQUIVALENCE|Our null hypothesis is that there is no statistically significant difference between the number of people who experienced vomiting in the above 2 groups.||||||0.07|||||||Chi-squared|||||||0.07
72560758|NCT02959840|144651832|EQUIVALENCE|Our null hypothesis is that there is no statistically significant difference between the number of people who experienced vomiting in the above 2 groups.||||||0.6|||||||Chi-squared|||||||0.6
72560759|NCT02959840|144651833|EQUIVALENCE|Our null hypothesis is that there is no statistically significant difference between the number of people who experienced vomiting in the above 2 groups.||||||0.2|||||||Chi-squared|||||||0.2
72560760|NCT02959840|144651833|EQUIVALENCE|Our null hypothesis is that there is no statistically significant difference between the number of people who experienced vomiting in the above 2 groups.||||||0.5|||||||Chi-squared|||||||0.5
72560761|NCT02959840|144651833|EQUIVALENCE|Our null hypothesis is that there is no statistically significant difference between the number of people who experienced vomiting in the above 2 groups.||||||0.7|||||||Chi-squared|||||||0.7
72560762|NCT02959840|144651834|EQUIVALENCE|Our null hypothesis is that there is no statistically significant difference between the number of people who experienced vomiting in the above 2 groups.||||||0.5|||||||Chi-squared|||||||0.5
72560763|NCT02959840|144651834|EQUIVALENCE|Our null hypothesis is that there is no statistically significant difference between the number of people who experienced vomiting in the above 2 groups.||||||1|||||||Chi-squared|||||||1
72619292|NCT01654250|144769241|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.7|STANDARD_ERROR_OF_MEAN|0.94||0.004|TWO_SIDED|95.0|-4.6|-0.9|||Mixed Models Analysis|||Hour 0.75 post-dose deportment subscale: Treatment comparisons for observed scores were assessed using a mixed model repeated measures analysis, with treatment (NWP09/Placebo), study center, time point and time point by treatment interaction as main effects and participant intercept as a random effect.||-0.9|-4.6|0.004
72619293|NCT01654250|144769241|SUPERIORITY_OR_OTHER||LS Mean difference|-3.9|STANDARD_ERROR_OF_MEAN|0.94|<|0.001|TWO_SIDED|95.0|-5.8|-2.1|||Mixed Models Analysis|||Hour 2 post-dose deportment subscale: Treatment comparisons for observed scores were assessed using a mixed model repeated measures analysis, with treatment (NWP09/Placebo), study center, time point and time point by treatment interaction as main effects and participant intercept as a random effect.||-2.1|-5.8|<0.001
72619294|NCT01654250|144769241|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.9|STANDARD_ERROR_OF_MEAN|0.94|<|0.001|TWO_SIDED|95.0|-5.8|-2.1|||Mixed Models Analysis|||Hour 4 post-dose deportment sub scale: Treatment comparisons for observed scores were assessed using a mixed model repeated measures analysis, with treatment (NWP09/Placebo), study center, time point and time point by treatment interaction as main effects and participant intercept as a random effect.||-2.1|-5.8|<0.001
72619295|NCT01654250|144769241|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.9|STANDARD_ERROR_OF_MEAN|0.94||0.042|TWO_SIDED|95.0|-3.8|-0.1|||Mixed Models Analysis|||Hour 8 post-dose deportment subscale: Treatment comparisons for observed scores were assessed using a mixed model repeated measures analysis, with treatment (NWP09/Placebo), study center, time point and time point by treatment interaction as main effects and participant intercept as a random effect.||-0.1|-3.8|0.042
72445555|NCT04169373|144406562|SUPERIORITY|To preserve the overall type I error rate at α=0.05 level, a multiple testing procedure was used to test the primary and multiplicity-controlled secondary endpoints. Testing began with the primary endpoint using two-sided α = 0.05; significance could be claimed for a lower ranked endpoint only if the previous endpoints in the sequence met the requirement of significance.|LS Mean Difference|-0.32|||<|0.0001|TWO_SIDED|95.0|-0.46|-0.18|||ANCOVA|ANCOVA model including treatment and screening hsCRP level as fixed factors and Baseline value as covariate.|Treatment difference = Upadacitinib - Placebo|||-0.18|-0.46|<0.0001
72445556|NCT04169373|144406563|SUPERIORITY|To preserve the overall type I error rate at α=0.05 level, a multiple testing procedure was used to test the primary and multiplicity-controlled secondary endpoints. Testing began with the primary endpoint using two-sided α = 0.05; significance could be claimed for a lower ranked endpoint only if the previous endpoints in the sequence met the requirement of significance.|LS Mean Difference|-1.5|||<|0.0001|TWO_SIDED|95.0|-2.0|-0.9|||Mixed-effect Model Repeated Measurement|MMRM model includes treatment, visit and treatment-by-visit interaction, screening hsCRP level (\> ULN vs ≤ ULN) and Baseline value as covariate.|Treatment difference = Upadacitinib - Placebo|||-0.9|-2.0|<0.0001
72445557|NCT04169373|144406564|OTHER||LS Mean Difference|-3.31|||<|0.0001|TWO_SIDED|95.0|-4.5|-2.12||This comparison was not part of the pre-specified multiplicity testing sequence.|ANCOVA|ANCOVA model including treatment and screening hsCRP level as fixed factors and Baseline value as covariate.|Treatment difference = Upadacitinib - Placebo|||-2.12|-4.50|<0.0001
72445558|NCT04169373|144406565|SUPERIORITY|To preserve the overall type I error rate at α=0.05 level, a multiple testing procedure was used to test the primary and multiplicity-controlled secondary endpoints. Testing began with the primary endpoint using two-sided α = 0.05; significance could be claimed for a lower ranked endpoint only if the previous endpoints in the sequence met the requirement of significance.|LS Mean Difference|-0.65|||<|0.0001|TWO_SIDED|95.0|-0.85|-0.45|||Mixed-effect Model Repeated Measurement|MMRM model includes treatment, visit, treatment-by-visit interaction, main stratification factors MRI and screening hsCRP status, and Baseline value.|Treatment difference = Upadacitinib - Placebo|||-0.45|-0.85|<0.0001
72445559|NCT04169373|144406566|SUPERIORITY|To preserve the overall type I error rate at α=0.05 level, a multiple testing procedure was used to test the primary and multiplicity-controlled secondary endpoints. Testing began with the primary endpoint using two-sided α = 0.05; significance could be claimed for a lower ranked endpoint only if the previous endpoints in the sequence met the requirement of significance.|LS Mean Difference|-3.06|||<|0.0001|TWO_SIDED|95.0|-4.08|-2.04|||ANCOVA|ANCOVA model including treatment, main stratification factor, treatment and stratification factor interaction and Baseline value as covariate.|Treatment difference = Upadacitinib - Placebo|||-2.04|-4.08|<0.0001
72445560|NCT04169373|144406567|SUPERIORITY|To preserve the overall type I error rate at α = 0.05 level, a multiple testing procedure was used to test the primary and multiplicity-controlled secondary endpoints. Testing began with the primary endpoint using two-sided α = 0.05; significance could be claimed for a lower ranked endpoint only if the previous endpoints in the sequence met the requirement of significance.|Response Rate Difference|20.1||||0.0001|TWO_SIDED|95.0|10.1|30.1|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by main stratification factor of MRI and screening hsCRP level status.|Response Rate Difference = Upadacitinib - Placebo|||30.1|10.1|0.0001
72445561|NCT04169373|144406567|OTHER||Odds Ratio (OR)|2.6|||||TWO_SIDED|95.0|1.6|4.2|||||Upadacitinib : Placebo|A post-hoc logistic regression adjusting for the main stratification factor of MRI and screening hsCRP status was conducted for the multiplicity-controlled binary endpoints assessed at Week 14.||4.2|1.6|
72445562|NCT04169373|144406568|SUPERIORITY|To preserve the overall type I error rate at α = 0.05 level, a multiple testing procedure was used to test the primary and multiplicity-controlled secondary endpoints. Testing began with the primary endpoint using two-sided α = 0.05; significance could be claimed for a lower ranked endpoint only if the previous endpoints in the sequence met the requirement of significance.|Response Rate Difference|8.8||||0.0063|TWO_SIDED|95.0|2.5|15.2|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by main stratification factor of MRI and screening hsCRP level status.|Response Rate Difference = Upadacitinib - Placebo|||15.2|2.5|0.0063
72560764|NCT02959840|144651834|EQUIVALENCE|Our null hypothesis is that there is no statistically significant difference between the number of people who experienced vomiting in the above 2 groups.||||||0.5|||||||Chi-squared|||||||0.5
72560765|NCT02959840|144651835|SUPERIORITY|Our null hypothesis is that there is no statistically significant difference between the mean satisfaction level in the above 2 groups.||||||0.02|||||||Fisher Exact|||||||0.02
72560766|NCT02959840|144651835|EQUIVALENCE|Our null hypothesis is that there is no statistically significant difference between the mean satisfaction level in the above 2 groups.||||||0.2|||||||Fisher Exact|||||||0.2
72560767|NCT02959840|144651835|EQUIVALENCE|Our null hypothesis is that there is no statistically significant difference between the mean satisfaction level in the above 2 groups.||||||0.3|||||||Fisher Exact|||||||0.3
72560768|NCT02959840|144651836|EQUIVALENCE|Our null hypothesis is that there is no statistically significant difference between the mean satisfaction level in the above 2 groups.||||||0.2|||||||Fisher Exact|||||||0.2
72560769|NCT02959840|144651836|EQUIVALENCE|Our null hypothesis is that there is no statistically significant difference between the mean satisfaction level in the above 2 groups.||||||0.5|||||||Fisher Exact|||||||0.5
72560770|NCT02959840|144651836|EQUIVALENCE|Our null hypothesis is that there is no statistically significant difference between the mean satisfaction level in the above 2 groups.||||||0.7|||||||Fisher Exact|||||||0.7
72560771|NCT00122447|144651932|SUPERIORITY_OR_OTHER||Slope|-0.941|STANDARD_ERROR_OF_MEAN|1.229||0.449|TWO_SIDED|95.0|-3.435|1.552||Association between treatment arm, compared to placebo, on change in hsCRP from baseline to 12 months of intervention, adjusted for age, sex, and race.|Regression, Linear|||||1.552|-3.435|0.449
72560772|NCT00122447|144651932|SUPERIORITY_OR_OTHER||Slope|-2.677|STANDARD_ERROR_OF_MEAN|1.211||0.034|TWO_SIDED|95.0|-5.133|-0.221||Association between treatment arm, compared to placebo, on change in hsCRP from baseline to 12 months of intervention, adjusted for age, sex, and race.|Regression, Linear|||||-0.221|-5.133|0.034
72560773|NCT00122447|144651932|SUPERIORITY_OR_OTHER||Slope|0.088|STANDARD_ERROR_OF_MEAN|1.21||0.943|TWO_SIDED|95.0|-2.367|2.542||Association between treatment arm, compared to placebo, on change in hsCRP from baseline to 12 months of intervention, adjusted for age, sex, and race.|Regression, Linear|||||2.542|-2.367|0.943
72445563|NCT04169373|144406568|OTHER||Odds Ratio (OR)|3.0|||||TWO_SIDED|95.0|1.3|7.0|||||Upadacitinib : Placebo|A post-hoc logistic regression adjusting for the main stratification factor of MRI and screening hsCRP status was conducted for the multiplicity-controlled binary endpoints assessed at Week 14.||7.0|1.3|
72445564|NCT04169373|144406569|SUPERIORITY|To preserve the overall type I error rate at α=0.05 level, a multiple testing procedure was used to test the primary and multiplicity-controlled secondary endpoints. Testing began with the primary endpoint using two-sided α = 0.05; significance could be claimed for a lower ranked endpoint only if the previous endpoints in the sequence met the requirement of significance.|LS Mean Difference|-0.92||||0.0004|TWO_SIDED|95.0|-1.42|-0.41|||Mixed-effect Model Repeated Measurement|MMRM model includes treatment, visit, treatment-by-visit interaction, main stratification factors MRI and screening hsCRP status, and Baseline value.|Treatment difference = Upadacitinib - Placebo|||-0.41|-1.42|0.0004
72445565|NCT04169373|144406570|SUPERIORITY|To preserve the overall type I error rate at α=0.05 level, a multiple testing procedure was used to test the primary and multiplicity-controlled secondary endpoints. Testing began with the primary endpoint using two-sided α = 0.05; significance could be claimed for a lower ranked endpoint only if the previous endpoints in the sequence met the requirement of significance.|LS Mean Difference|-1.12||||0.0001|TWO_SIDED|95.0|-1.68|-0.55|||Mixed-effect Model Repeated Measurement|MMRM model includes treatment, visit, treatment-by-visit interaction, main stratification factors MRI and screening hsCRP status, and Baseline value.|Treatment difference = Upadacitinib - Placebo|||-0.55|-1.68|0.0001
72445566|NCT04169373|144406571|SUPERIORITY|To preserve the overall type I error rate at α = 0.05 level, a multiple testing procedure was used to test the primary and multiplicity-controlled secondary endpoints. Testing began with the primary endpoint using two-sided α = 0.05; significance could be claimed for a lower ranked endpoint only if the previous endpoints in the sequence met the requirement of significance.|Response Rate Difference|23.8|||<|0.0001|TWO_SIDED|95.0|14.2|33.4|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by main stratification factor of MRI and screening hsCRP level status.|Response Rate Difference = Upadacitinib - Placebo|||33.4|14.2|<0.0001
72445567|NCT04169373|144406571|OTHER||Odds Ratio (OR)|3.2|||||TWO_SIDED|95.0|1.9|5.4|||||Upadacitinib : Placebo|A post-hoc logistic regression adjusting for the main stratification factor of MRI and screening hsCRP status was conducted for the multiplicity-controlled binary endpoints assessed at Week 14.||5.4|1.9|
72445568|NCT04169373|144406572|SUPERIORITY|To preserve the overall type I error rate at α = 0.05 level, a multiple testing procedure was used to test the primary and multiplicity-controlled secondary endpoints. Testing began with the primary endpoint using two-sided α = 0.05; significance could be claimed for a lower ranked endpoint only if the previous endpoints in the sequence met the requirement of significance.|Response Rate Difference|10.9||||0.0035|TWO_SIDED|95.0|3.6|18.3|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by main stratification factor of MRI and screening hsCRP level status.|Response Rate Difference = Upadacitinib - Placebo|||18.3|3.6|0.0035
72445569|NCT04169373|144406572|OTHER||Odds Ratio (OR)|2.7|||||TWO_SIDED|95.0|1.3|5.6|||||Upadacitinib : Placebo|A post-hoc logistic regression adjusting for the main stratification factor of MRI and screening hsCRP status was conducted for the multiplicity-controlled binary endpoints assessed at Week 14.||5.6|1.3|
72445570|NCT04169373|144406573|SUPERIORITY|To preserve the overall type I error rate at α=0.05 level, a multiple testing procedure was used to test the primary and multiplicity-controlled secondary endpoints. Testing began with the primary endpoint using two-sided α = 0.05; significance could be claimed for a lower ranked endpoint only if the previous endpoints in the sequence met the requirement of significance.|LS Mean Difference|-1.14|||<|0.0001|TWO_SIDED|95.0|-1.6|-0.68|||Mixed-effect Model Repeated Measurement|MMRM model includes treatment, visit, treatment-by-visit interaction, main stratification factors MRI and screening hsCRP status, and Baseline value.|Treatment difference = Upadacitinib - Placebo|||-0.68|-1.60|<0.0001
72445571|NCT04169373|144406574|SUPERIORITY|To preserve the overall type I error rate at α=0.05 level, a multiple testing procedure was used to test the primary and multiplicity-controlled secondary endpoints. Testing began with the primary endpoint using two-sided α = 0.05; significance could be claimed for a lower ranked endpoint only if the previous endpoints in the sequence met the requirement of significance.|LS Mean Difference|-2.23|||<|0.0001|TWO_SIDED|95.0|-3.26|-1.21|||Mixed-effect Model Repeated Measurement|MMRM model includes treatment, visit, treatment-by-visit interaction, main stratification factors MRI and screening hsCRP status, and Baseline value.|Treatment difference = Upadacitinib - Placebo|||-1.21|-3.26|<0.0001
72445572|NCT04169373|144406575|SUPERIORITY|To preserve the overall type I error rate at α=0.05 level, a multiple testing procedure was used to test the primary and multiplicity-controlled secondary endpoints. Testing began with the primary endpoint using two-sided α = 0.05; significance could be claimed for a lower ranked endpoint only if the previous endpoints in the sequence met the requirement of significance.|LS Mean Difference|-1.78|||<|0.0001|TWO_SIDED|95.0|-2.56|-1.0|||Mixed-effect Model Repeated Measurement|MMRM model includes treatment, visit, treatment-by-visit interaction, main stratification factors MRI and screening hsCRP status, and Baseline value.|Treatment difference = Upadacitinib - Placebo|||-1.00|-2.56|<0.0001
72445573|NCT04169373|144406576|SUPERIORITY|To preserve the overall type I error rate at α = 0.05 level, a multiple testing procedure was used to test the primary and multiplicity-controlled secondary endpoints. Testing began with the primary endpoint using two-sided α = 0.05; significance could be claimed for a lower ranked endpoint only if the previous endpoints in the sequence met the requirement of significance.|Response Rate Difference|22.8|||<|0.0001|TWO_SIDED|95.0|12.2|33.4|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by main stratification factor of MRI and screening hsCRP level status.|Response Rate Difference = Upadacitinib - Placebo|||33.4|12.2|<0.0001
72445574|NCT04169373|144406576|OTHER||Odds Ratio (OR)|2.5|||||TWO_SIDED|95.0|1.6|4.0|||||Upadacitinib : Placebo|A post-hoc logistic regression adjusting for the main stratification factor of MRI and screening hsCRP status was conducted for the multiplicity-controlled binary endpoints assessed at Week 14.||4.0|1.6|
72497633|NCT01512264|144525179|OTHER|||||||0.618|||||||t-test, 2 sided|||paired t- test between time point 1 and time point 5 for 1 week of Sham Treatment + 2 weeks of nerTMS group and BNT test were calculated. Cohen's d was calculated to determine the power of the test. The Cohen's d calculated for this test = 0.57.||||0.618
72497634|NCT01512264|144525179|OTHER|||||||1|||||||t-test, 2 sided|||paired t- test between time point 1 and time point 5 for 2 weeks of Sham Treatment + 1 week of nerTMS group and BNT test were calculated. Cohen's d was calculated to determine the power of the test. The Cohen's d calculated for this test = 1.31.||||1.000
72445575|NCT04169373|144406577|SUPERIORITY|To preserve the overall type I error rate at α=0.05 level, a multiple testing procedure was used to test the primary and multiplicity-controlled secondary endpoints. Testing began with the primary endpoint using two-sided α = 0.05; significance could be claimed for a lower ranked endpoint only if the previous endpoints in the sequence met the requirement of significance.|LS Mean Difference|-0.1||||0.1781|TWO_SIDED|95.0|-0.25|0.05|||ANCOVA|ANCOVA model including treatment and main stratification factor MRI and hsCRP status as fixed factors and Baseline value as covariate.|Treatment difference = Upadacitinib - Placebo|||0.05|-0.25|0.1781
72445576|NCT04169373|144406578|OTHER||LS Mean Difference|-0.7||||0.0193|TWO_SIDED|95.0|-1.3|-0.1|||Mixed-effect Model Repeated Measurement|MMRM model includes treatment, visit, treatment-by-visit interaction, main stratification factors MRI and screening hsCRP status, and Baseline value.|Treatment difference = Upadacitinib - Placebo|||-0.1|-1.3|0.0193
72445577|NCT04169373|144406579|SUPERIORITY||Response Rate Difference|20.1||||0.0003|TWO_SIDED|95.0|9.3|30.9|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by main stratification factor of MRI and screening hsCRP level status.|Response Rate Difference = Upadacitinib - Placebo|||30.9|9.3|0.0003
72445578|NCT04169373|144406580|OTHER||LS Mean Difference|-1.13||||0.0206|TWO_SIDED|95.0|-2.08|-0.17||This comparison was not part of the pre-specified multiplicity testing sequence.|ANCOVA|ANCOVA model including treatment and main stratification factors MRI and hsCRP status as fixed factors and Baseline value as covariate.|Treatment difference = Upadacitinib - Placebo|||-0.17|-2.08|0.0206
72445579|NCT04169373|144406582|SUPERIORITY||Response Rate Difference|17.6||||0.0004|TWO_SIDED|95.0|7.9|27.3||This comparison was not part of the pre-specified multiplicity testing sequence.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by main stratification factor of MRI and screening hsCRP level status.|Response Rate Difference = Upadacitinib - Placebo|||27.3|7.9|0.0004
72445580|NCT04169373|144406583|SUPERIORITY||Response Rate Difference|21.9|||<|0.0001|TWO_SIDED|95.0|13.2|30.6||This comparison was not part of the pre-specified multiplicity testing sequence.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by main stratification factor of MRI and screening hsCRP level status.|Response Rate Difference = Upadacitinib - Placebo|||30.6|13.2|<0.0001
72445581|NCT04169373|144406584|SUPERIORITY||Response Rate Difference|23.1|||<|0.0001|TWO_SIDED|95.0|12.4|33.7||This comparison was not part of the pre-specified multiplicity testing sequence.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by main stratification factor of MRI and screening hsCRP level status.|Response Rate Difference = Upadacitinib - Placebo|||33.7|12.4|<0.0001
72445582|NCT04610892|144406585|SUPERIORITY||Least Square Mean difference|-8.3797||||0.065||90.0|-17.498|0.7387||One-sided p-value|ANCOVA|The treatment as a fixed effects and the baseline value and the geographic region and statin therapy intensity at screening as covariates.||||0.7387|-17.4980|0.065
72445583|NCT04610892|144406585|SUPERIORITY||Least Square Mean difference|2.3915||||0.747||90.0|-3.5338|8.3167||One-sided p-value|ANCOVA|The treatment as a fixed effects and the baseline value and the geographic region and statin therapy intensity at screening as covariates.||||8.3167|-3.5338|0.747
72497635|NCT01512264|144525179|OTHER|||||||0.019|||||||t-test, 2 sided|||paired t- test between time point 1 and time point 5 for the control group and BNT test were calculated. Cohen's d was calculated to determine the power of the test. The Cohen's d calculated for this test = 4.35.||||0.019
72497636|NCT01512264|144525181|OTHER|||||||0.118|||||||t-test, 2 sided|||paired t- test between time point 1 and time point 4 for the rTMS group and SFT test were calculated. Cohen's d was calculated to determine the power of the test. The Cohen's d calculated for this test = -0.69.||||0.118
72445584|NCT04610892|144406585|SUPERIORITY||Least Square Mean difference|0.5766||||0.563||90.0|-5.4389|6.5921||One-sided p-value|ANCOVA|The treatment as a fixed effects and the baseline value and the geographic region and statin therapy intensity at screening as covariates.||||6.5921|-5.4389|0.563
72445585|NCT04610892|144406585|SUPERIORITY||Least Square Mean difference|1.5204||||0.685||90.0|-3.6657|6.7064||One-sided p-value|ANCOVA|The treatment as a fixed effects and the baseline value and the geographic region and statin therapy intensity at screening as covariates.||||6.7064|-3.6657|0.685
72445586|NCT04610892|144406586|SUPERIORITY||Geometric LS mean ratio estimate|1.12||||0.854||90.0|0.94|1.33||One sided p-value|Mixed model with repeated measurements|The model was adjusted for the baseline value and the stratification factors (geographic region and statin therapy intensity at screening).||||1.33|0.94|0.854
72445587|NCT04610892|144406586|SUPERIORITY||Geometric LS mean ratio estimate|1.06||||0.79||90.0|0.94|1.18||One sided p-value|Mixed model with repeated measurements|The model was adjusted for the baseline value and the stratification factors (geographic region and statin therapy intensity at screening).||||1.18|0.94|0.790
72445588|NCT04610892|144406586|SUPERIORITY||Geometric LS mean ratio estimate|1.0||||0.498||90.0|0.89|1.12||One sided p-value|Mixed model with repeated measurements|The model was adjusted for the baseline value and the stratification factors (geographic region and statin therapy intensity at screening).||||1.12|0.89|0.498
72445589|NCT04610892|144406586|SUPERIORITY||Geometric LS mean ratio estimate|1.03||||0.678||90.0|0.93|1.13||One sided p-value|Mixed model with repeated measurements|The model was adjusted for the baseline value and the stratification factors (geographic region and statin therapy intensity at screening).||||1.13|0.93|0.678
72560774|NCT00122447|144651933|SUPERIORITY_OR_OTHER||Slope|-0.001|STANDARD_ERROR_OF_MEAN|0.012||0.943|TWO_SIDED|95.0|-0.025|0.023||Association between treatment arm, compared to placebo, on change in FMD from baseline to 12 months of intervention, adjusted for age, sex, race, and LDL-cholesterol.|Regression, Linear|||Null hypothesis: no difference between active treatment group compared to placebo.||0.023|-0.025|0.943
72497637|NCT01512264|144525181|OTHER|||||||0.482|||||||t-test, 2 sided|||paired t- test between time point 1 and time point 4 for the 1 week of Sham Treatment + 2 weeks of nerTMS group and SFT test were calculated. Cohen's d was calculated to determine the power of the test. The Cohen's d calculated for this test = -0.28.||||0.482
72497638|NCT01512264|144525181|OTHER|||||||0.368|||||||t-test, 2 sided|||paired t- test between time point 1 and time point 4 for the 2 weeks of Sham Treatment +1 week of nerTMS group and SFT test were calculated. Cohen's d was calculated to determine the power of the test. The Cohen's d calculated for this test = -0.37.||||0.368
72445590|NCT04610892|144406587|SUPERIORITY||Least Squares mean difference|-1.44||||0.99||90.0|-2.44|-0.43||One sided p-value|ANCOVA|The model was adjusted for the baseline value and stratification factors (geographic region and statin therapy intensity at screening).||||-0.43|-2.44|0.990
72445591|NCT04610892|144406587|SUPERIORITY||Least Squares mean difference|-0.21||||0.697||90.0|-0.87|0.45||One sided p-value|ANCOVA|The model was adjusted for the baseline value and stratification factors (geographic region and statin therapy intensity at screening).||||0.45|-0.87|0.697
72445592|NCT04610892|144406587|SUPERIORITY||Least Squares mean difference|-0.42||||0.849||90.0|-1.08|0.25||One sided p-value|ANCOVA|The model was adjusted for the baseline value and stratification factors (geographic region and statin therapy intensity at screening).||||0.25|-1.08|0.849
72445593|NCT04610892|144406587|SUPERIORITY||Least Squares mean difference|-0.31||||0.811||90.0|-0.89|0.27||One sided p-value|ANCOVA|The model was adjusted for the baseline value and stratification factors (geographic region and statin therapy intensity at screening).||||0.27|-0.89|0.811
72445594|NCT04610892|144406588|SUPERIORITY||Least Squares mean difference|-3.5||||0.972||90.0|-6.49|-0.5||One sided p-value|ANCOVA|The model was adjusted for the baseline value and stratification factors (geographic region and statin therapy intensity at screening).||||-0.50|-6.49|0.972
72445595|NCT04610892|144406588|SUPERIORITY||Least Squares mean difference|-1.1||||0.777||90.0|-3.49|1.3||One sided p-value|ANCOVA|The model was adjusted for the baseline value and stratification factors (geographic region and statin therapy intensity at screening).||||1.30|-3.49|0.777
72445596|NCT04610892|144406588|SUPERIORITY||Least Squares mean difference|-0.32||||0.596||90.0|-2.54|1.89||One sided p-value|ANCOVA|The model was adjusted for the baseline value and stratification factors (geographic region and statin therapy intensity at screening).||||1.89|-2.54|0.596
72445597|NCT04610892|144406588|SUPERIORITY||Least Squares mean difference|-0.63||||0.698||90.0|-2.64|1.38||One sided p-value|ANCOVA|The model was adjusted for the baseline value and stratification factors (geographic region and statin therapy intensity at screening).||||1.38|-2.64|0.698
72619296|NCT01654250|144769241|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.5|STANDARD_ERROR_OF_MEAN|0.94||0.118|TWO_SIDED|95.0|-3.3|0.4|||Mixed Models Analysis|||Hour 10 post-dose deportment sub scale: Treatment comparisons for observed scores were assessed using a mixed model repeated measures analysis, with treatment (NWP09/Placebo), study center, time point and time point by treatment interaction as main effects and participant intercept as a random effect.||0.4|-3.3|0.118
72445598|NCT04610892|144406589|SUPERIORITY||Least Squares mean difference|-1.29||||0.981||90.0|-2.32|-0.27||One sided p-value|ANCOVA|The model was adjusted for the baseline value and stratification factors (geographic region and statin therapy intensity at screening).||||-0.27|-2.32|0.981
72445599|NCT04610892|144406589|SUPERIORITY||Least Squares mean difference|-0.8||||0.974||90.0|-1.47|-0.12||One sided p-value|ANCOVA|The model was adjusted for the baseline value and stratification factors (geographic region and statin therapy intensity at screening).||||-0.12|-1.47|0.974
72445600|NCT04610892|144406589|SUPERIORITY||Least Squares mean difference|-0.86||||0.983||90.0|-1.53|-0.2||One sided p-value|ANCOVA|The model was adjusted for the baseline value and stratification factors (geographic region and statin therapy intensity at screening).||||-0.20|-1.53|0.983
72445601|NCT04610892|144406589|SUPERIORITY||Least Squares mean difference|-0.83||||0.99||90.0|-1.42|-0.25||One sided p-value|ANCOVA|The model was adjusted for the baseline value and stratification factors (geographic region and statin therapy intensity at screening).||||-0.25|-1.42|0.990
72445602|NCT04610892|144406590|SUPERIORITY||Least Squares mean difference|-2.14||||0.959||90.0|-4.16|-0.12||One sided p-value|ANCOVA|The model was adjusted for the baseline value and stratification factors (geographic region and statin therapy intensity at screening).||||-0.12|-4.16|0.959
72445603|NCT04610892|144406590|SUPERIORITY||Least Squares mean difference|-2.92||||0.998||90.0|-4.53|-1.31||One sided p-value|ANCOVA|The model was adjusted for the baseline value and stratification factors (geographic region and statin therapy intensity at screening).||||-1.31|-4.53|0.998
72445604|NCT04610892|144406590|SUPERIORITY||Least Squares mean difference|-1.35||||0.939||90.0|-2.79|0.09||One sided p-value|ANCOVA|The model was adjusted for the baseline value and stratification factors (geographic region and statin therapy intensity at screening).||||0.09|-2.79|0.939
72445605|NCT04610892|144406590|SUPERIORITY||Least Squares mean difference|-1.94||||0.991||90.0|-3.27|-0.62||One sided p-value|ANCOVA|The model was adjusted for the baseline value and stratification factors (geographic region and statin therapy intensity at screening).||||-0.62|-3.27|0.991
72445606|NCT04610892|144406591|SUPERIORITY||Least Squares mean difference|-16.137||||0.077||90.0|-34.7829|2.5089||One sided p-value|ANCOVA|The model was adjusted for the baseline value and stratification factors (geographic region and statin therapy intensity at screening).||||2.5089|-34.7829|0.077
72445607|NCT04610892|144406591|SUPERIORITY||Least Squares mean difference|-0.5927||||0.468||90.0|-12.7267|11.5413||One sided p-value|ANCOVA|The model was adjusted for the baseline value and stratification factors (geographic region and statin therapy intensity at screening).||||11.5413|-12.7267|0.468
72445608|NCT04610892|144406591|SUPERIORITY||Least Squares mean difference|-0.1767||||0.491||90.0|-12.4678|12.1144||One sided p-value|ANCOVA|The model was adjusted for the baseline value and stratification factors (geographic region and statin therapy intensity at screening).||||12.1144|-12.4678|0.491
72445609|NCT04610892|144406591|SUPERIORITY||Least Squares mean difference|-0.393||||0.476||90.0|-11.0022|10.2162||One sided p-value|ANCOVA|The model was adjusted for the baseline value and stratification factors (geographic region and statin therapy intensity at screening).||||10.2162|-11.0022|0.476
72445610|NCT04610892|144406592|SUPERIORITY||Least Squares mean difference|-4.3435||||0.136||90.0|-10.8637|2.1768||One sided p-value|ANCOVA|The model was adjusted for the baseline value and stratification factors (geographic region and statin therapy intensity at screening).||||2.1768|-10.8637|0.136
72445611|NCT04610892|144406592|SUPERIORITY||Least Squares mean difference|-1.2369||||0.316||90.0|-5.4796|3.0059||One sided p-value|ANCOVA|The model was adjusted for the baseline value and stratification factors (geographic region and statin therapy intensity at screening).||||3.0059|-5.4796|0.316
72619297|NCT01654250|144769241|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|0.94||0.342|TWO_SIDED|95.0|-2.7|1.9|||Mixed Models Analysis|||Hour 12 post-dose deportment sub scale: Treatment comparisons for observed scores were assessed using a mixed model repeated measures analysis, with treatment (NWP09/Placebo), study center, time point and time point by treatment interaction as main effects and participant intercept as a random effect.||1.9|-2.7|0.342
72619298|NCT01654250|144769241|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.94||0.962|TWO_SIDED|95.0|-1.8|1.9|||Mixed Models Analysis|||Hour 13 post-dose deportment sub scale: Treatment comparisons for observed scores were assessed using a mixed model repeated measures analysis, with treatment (NWP09/Placebo), study center, time point and time point by treatment interaction as main effects and participant intercept as a random effect.||1.9|-1.8|0.962
72445612|NCT04610892|144406592|SUPERIORITY||Least Squares mean difference|-0.7015||||0.394||90.0|-5.0096|3.6065||One sided p-value|ANCOVA|The model was adjusted for the baseline value and stratification factors (geographic region and statin therapy intensity at screening).||||3.6065|-5.0096|0.394
72445613|NCT04610892|144406592|SUPERIORITY||Least Squares mean difference|-0.9799||||0.332||90.0|-4.6927|2.7329||One sided p-value|ANCOVA|The model was adjusted for the baseline value and stratification factors (geographic region and statin therapy intensity at screening).||||2.7329|-4.6927|0.332
72445614|NCT05520190|144406602|SUPERIORITY||Standardized Response Mean|-0.47|||||TWO_SIDED||||||||Baseline Attitude score - 1-month Attitude score / SD of average change|||||
72445615|NCT05520190|144406603|SUPERIORITY||Standardized Response Mean|-0.23|||||TWO_SIDED||||||||Baseline Norm score - 1-month Norm score / SD of average change|||||
72445616|NCT05520190|144406604|SUPERIORITY||Standardized Response Mean|-0.03|||||TWO_SIDED||||||||Baseline Perceived Behavioral Control score - 1-month Perceived Behavioral Control score / SD of average change|||||
72445617|NCT05520190|144406605|SUPERIORITY||Standardized Response Mean|-0.16|||||TWO_SIDED||||||||Baseline Intention score - 1-month Intention score / SD of average change|||||
72445618|NCT05520190|144406606|SUPERIORITY||Standardized Response Mean|0.35|||||TWO_SIDED||||||||Baseline drinks per day - 1-month drinks per day / avg change in drinks per day|||||
72445619|NCT05520190|144406607|SUPERIORITY||Standardized Response Mean|0.35|||||TWO_SIDED||||||||Baseline drinking days - 1-month drinking days / SD of avg change in drinking days|||||
72619299|NCT01654250|144769242|SUPERIORITY_OR_OTHER||LS Mean difference|25.3|STANDARD_ERROR_OF_MEAN|11.12||0.024|TWO_SIDED|95.0|3.4|47.1|||Mixed Models Analysis|||Hour 0.75 post-dose (Problems attempted): Treatment comparisons for observed scores were assessed using a mixed model repeated measures analysis, with treatment (NWP09/Placebo), study center, time point and time point by treatment interaction as main effects and participant intercept as a random effect.||47.1|3.4|0.024
72445620|NCT05520190|144406608|SUPERIORITY||Standardized Response Mean|0.3|||||TWO_SIDED||||||||Baseline binge drinking days - 1-month binge drinking days / avg change in binge drinking days|||||
72445621|NCT05520190|144406609|SUPERIORITY||Standardized Response Mean|1.23|||||TWO_SIDED||||||||Baseline depression - 1-month depression / SD of avg change in depression|||||
72445622|NCT05520190|144406610|SUPERIORITY||Standardized Response Mean|1.06|||||TWO_SIDED||||||||Baseline anxiety - 1-month anxiety / SD avg change in anxiety|||||
72445623|NCT05520190|144406611|SUPERIORITY||Standardized Response Mean|0.9|||||TWO_SIDED||||||||Baseline PTSD - 1-month PTSd / SD avg change in PTSD|||||
72445624|NCT05520190|144406612|SUPERIORITY||Standardized Response Mean|0.6|||||TWO_SIDED||||||||Baseline insomnia - 1-month insomnia / SD avg change in insomnia|||||
72445625|NCT05520190|144406613|SUPERIORITY||Standardized Response Mean|0.58|||||TWO_SIDED||||||||Baseline Alcohol Screen - 1-month Alcohol Screen / SD avg change|||||
72445626|NCT05520190|144406614|SUPERIORITY||Standardized Response Mean|-0.39|||||TWO_SIDED||||||||Baseline behavioral beliefs - 1-month behavioral beliefs / avg change in behavioral beliefs|||||
72445627|NCT05520190|144406615|SUPERIORITY||Standardized Response Mean|-0.62|||||TWO_SIDED||||||||Baseline normative beliefs - 1-month normative beliefs / SD avg change in normative beliefs|||||
72497639|NCT01512264|144525181|OTHER|||||||0.147|||||||t-test, 2 sided|||paired t- test between time point 1 and time point 4 for the control group and SFT test were calculated. Cohen's d was calculated to determine the power of the test. The Cohen's d calculated for this test = -0.70.||||0.147
72497640|NCT01512264|144525182|OTHER|||||||0.41|||||||t-test, 2 sided|||paired t- test between time point 1 and time point 5 for the rTMS group and SFT test were calculated. Cohen's d was calculated to determine the power of the test. The Cohen's d calculated for this test = -0.54.||||0.410
72497641|NCT01512264|144525182|OTHER|||||||0.695|||||||t-test, 2 sided|||paired t- test between time point 1 and time point 5 for the 1 week of Sham Treatment + 2 weeks of nerTMS group and SFT test were calculated. Cohen's d was calculated to determine the power of the test. The Cohen's d calculated for this test = 0.25.||||0.695
72497642|NCT01512264|144525182|OTHER|||||||0.175|||||||t-test, 2 sided|||paired t- test between time point 1 and time point 5 for the 2 weeks of Sham Treatment +1 week of nerTMS group and SFT test were calculated. Cohen's d was calculated to determine the power of the test. The Cohen's d calculated for this test = -0.25.||||0.175
72445628|NCT05520190|144406616|SUPERIORITY||Standardized Response Mean|-0.83|||||TWO_SIDED||||||||Baseline control beliefs - 1-month control beliefs / SD avg change in control beliefs|||||
72445629|NCT01999075|144406617|SUPERIORITY||Mean Difference (Net)|1.9||||0.68|TWO_SIDED|95.0|-6.9|10.7||The a priori threshold for statistical significance was a two-sided p-value of 0.05.|ANCOVA||"The mean difference between the intervention and the control group in the change from baseline to 2 years was estimated.~Estimates presented here are based on multiple imputation of missing values."|||10.7|-6.9|0.68
72445630|NCT01999075|144406621|SUPERIORITY||Mean Difference (Net)|0.27|||||TWO_SIDED|95.0|-1.92|2.18||||||Difference in change in peak cough flow (L/min) from baseline to 2 years, between conventional treatment and intervention group.||2.18|-1.92|
72445631|NCT01999075|144406622|SUPERIORITY|||||||0.79|||||||Mixed Models Analysis|||||||0.79
72445632|NCT01999075|144406623|SUPERIORITY|||||||1|||||||Mixed Models Analysis|||||||1.00
72445633|NCT01999075|144406624|SUPERIORITY|||||||0.98|||||||Mixed Models Analysis|||||||0.98
72497643|NCT01512264|144525182|OTHER|||||||0.518|||||||t-test, 2 sided|||paired t- test between time point 1 and time point 5 for the control group and SFT test were calculated. Cohen's d was calculated to determine the power of the test. The Cohen's d calculated for this test = -0.60.||||0.518
72619300|NCT01654250|144769242|SUPERIORITY_OR_OTHER||LS Mean Difference|36.1|STANDARD_ERROR_OF_MEAN|11.12||0.001|TWO_SIDED|95.0|14.2|57.9|||Mixed Models Analysis|||Hour 2 post-dose (Problems attempted): Treatment comparisons for observed scores were assessed using a mixed model repeated measures analysis, with treatment (NWP09/Placebo), study center, time point and time point by treatment interaction as main effects and participant intercept as a random effect.||57.9|14.2|0.001
72445634|NCT03683719|144406627|SUPERIORITY||||||<|0.001||||||"P-values were adjusted for multiple comparisons. Models with an adjusted p-value \<0.025 were statistically sign. different from a flat dose-response model. Model: IGA-CHE TS = Treatment + Region + Baseline IGA-CHE.~Model selected: Emax model"|Multiple contrast test|||The primary endpoint was evaluated by determining if there was a dose-response relationship between the IGA-CHE response rate at Week 16 and the dose administered, using the Multiple Comparison Procedure - Modelling (MCP-Mod) methodology. Several candidate parametric models were assumed and multiple comparison techniques were used to choose the model(s) most likely to represent the true underlying dose-response curve.||||<0.001
72445635|NCT03683719|144406627|SUPERIORITY||Risk Difference (RD)|13.29|||>|0.05|TWO_SIDED|95.0|0.34|26.24||The statistical test was not controlled for multiplicity. Data at visits following premature discont. of IMP or initiation of rescue medication before Week 16 were considered missing and imputed as non-responders (as were any other missing data).|Cochran-Mantel-Haenszel|||The difference in response rates between the active delgocitinib cream doses and delgocitinib cream vehicle was analysed separately for each of the active dose groups using the Cochran-Mantel-Haenszel test stratified by region and disease severity (baseline IGA-CHE score). The null hypothesis of no difference in response rates between the delgocitinib cream active doses and delgocitinib cream vehicle was tested against the 2-sided alternative that there is a difference.||26.24|0.34|>0.05
72445636|NCT03683719|144406627|SUPERIORITY||Risk Difference (RD)|-0.03|||>|0.05|TWO_SIDED|95.0|-10.44|10.39||The statistical test was not controlled for multiplicity. Data at visits following premature discont. of IMP or initiation of rescue medication before Week 16 were considered missing and imputed as non-responders (as were any other missing data).|Cochran-Mantel-Haenszel|||The difference in response rates between the active delgocitinib cream doses and delgocitinib cream vehicle was analysed separately for each of the active dose groups using the Cochran-Mantel-Haenszel test stratified by region and disease severity (baseline IGA-CHE score). The null hypothesis of no difference in response rates between the delgocitinib cream active doses and delgocitinib cream vehicle was tested against the 2-sided alternative that there is a difference.||10.39|-10.44|>0.05
72445637|NCT03683719|144406627|SUPERIORITY||Risk Difference (RD)|28.22|||<|0.001|TWO_SIDED|95.0|13.8|42.64||The statistical test was not controlled for multiplicity. Data at visits following premature discont. of IMP or initiation of rescue medication before Week 16 were considered missing and imputed as non-responders (as were any other missing data).|Cochran-Mantel-Haenszel|||The difference in response rates between the active delgocitinib cream doses and delgocitinib cream vehicle was analysed separately for each of the active dose groups using the Cochran-Mantel-Haenszel test stratified by region and disease severity (baseline IGA-CHE score). The null hypothesis of no difference in response rates between the delgocitinib cream active doses and delgocitinib cream vehicle was tested against the 2-sided alternative that there is a difference.||42.64|13.8|<0.001
72445638|NCT03683719|144406627|SUPERIORITY||Risk Difference (RD)|29.61|||<|0.001|TWO_SIDED|95.0|14.56|44.67||The statistical test was not controlled for multiplicity. Data at visits following premature discont. of IMP or initiation of rescue medication before Week 16 were considered missing and imputed as non-responders (as were any other missing data).|Cochran-Mantel-Haenszel|||The difference in response rates between the active delgocitinib cream doses and delgocitinib cream vehicle was analysed separately for each of the active dose groups using the Cochran-Mantel-Haenszel test stratified by region and disease severity (baseline IGA-CHE score). The null hypothesis of no difference in response rates between the delgocitinib cream active doses and delgocitinib cream vehicle was tested against the 2-sided alternative that there is a difference.||44.67|14.56|<0.001
72445639|NCT03683719|144406628|SUPERIORITY||||||<|0.0001||||||"P-values were adjusted for multiple comparisons. Models with an adj. p-value \<0.025 were statistically sign. different from a flat dose-response model. Model: Change = Treatment + Baseline + Region + Baseline IGA-CHE.~Model selected: Emax model"|Multiple contrast test|||"The secondary endpoint Change from baseline to Week 16 in HECSI score was evaluated by determining if there was a dose-response relationship between the change from baseline in HECSI score at Week 16 and the dose administered, using the Multiple Comparison Procedure - Modelling (MCP-Mod) methodology. Several candidate parametric models were assumed and multiple comparison techniques were used to choose the model(s) most likely to represent the true underlying dose-response curve."||||<0.0001
72445640|NCT03683719|144406628|SUPERIORITY||Mean Difference (Net)|-13.41|||<|0.01|TWO_SIDED|95.0|-22.82|-4.01||The statistical test was not controlled for multiplicity. Data at visits following premature discont. of IMP or initiation of rescue med. before Week 16 were considered missing and imputed with MMRM predicted values (as were any other missing data).|Mixed Models Analysis|||"Least Square (LS) Means were calculated using a mixed model for repeated measurements on the post-baseline responses up to Week 16 with an unstructured covariance matrix, Kenward-Roger approximation to estimate denominator degrees of freedom, and the mean modelled as follows:~Change from baseline in HECSI~= treatment × visit + baseline HECSI × visit + region + baseline IGA-CHE.~The primary comparison between each active delgocitinib dose and vehicle was at Week 16."||-4.01|-22.82|<0.01
72445641|NCT03683719|144406628|SUPERIORITY||Mean Difference (Net)|-9.53|||<|0.05|TWO_SIDED|95.0|-19.04|-0.02||The statistical test was not controlled for multiplicity. Data at visits following premature discont. of IMP or initiation of rescue med. before Week 16 were considered missing and imputed with MMRM predicted values (as were any other missing data).|Mixed Models Analysis|||"Least Square (LS) Means were calculated using a mixed model for repeated measurements on the post-baseline responses up to Week 16 with an unstructured covariance matrix, Kenward-Roger approximation to estimate denominator degrees of freedom, and the mean modelled as follows:~Change from baseline in HECSI~= treatment × visit + baseline HECSI × visit + region + baseline IGA-CHE.~The primary comparison between each active delgocitinib dose and vehicle was at Week 16."||-0.02|-19.04|<0.05
72445642|NCT03683719|144406628|SUPERIORITY||Mean Difference (Net)|-20.29|||<|0.0001|TWO_SIDED|95.0|-29.56|-11.02||The statistical test was not controlled for multiplicity. Data at visits following premature discont. of IMP or initiation of rescue med. before Week 16 were considered missing and imputed with MMRM predicted values (as were any other missing data).|Mixed Models Analysis|||"Least Square (LS) Means were calculated using a mixed model for repeated measurements on the post-baseline responses up to Week 16 with an unstructured covariance matrix, Kenward-Roger approximation to estimate denominator degrees of freedom, and the mean modelled as follows:~Change from baseline in HECSI~= treatment × visit + baseline HECSI × visit + region + baseline IGA-CHE.~The primary comparison between each active delgocitinib dose and vehicle was at Week 16."||-11.02|-29.56|<0.0001
72560775|NCT00122447|144651933|SUPERIORITY_OR_OTHER||Slope|0.014|STANDARD_ERROR_OF_MEAN|0.013||0.28|TWO_SIDED|95.0|-0.012|0.039||Association between treatment arm, compared to placebo, on change in FMD from baseline to 12 months of intervention, adjusted for age, sex, race, and LDL-cholesterol.|Regression, Linear|||||0.039|-0.012|0.280
72560776|NCT00122447|144651933|SUPERIORITY_OR_OTHER||Slope|0.012|STANDARD_ERROR_OF_MEAN|0.012||0.313|TWO_SIDED|95.0|-0.012|0.037||Association between treatment arm, compared to placebo, on change in FMD from baseline to 12 months of intervention, adjusted for age, sex, race, and LDL-cholesterol.|Regression, Linear|||||0.037|-0.012|0.313
72560777|NCT01453153|144651953|SUPERIORITY||percentage of participants|0.0|||||TWO_SIDED|95.0|0.0|60.0||||||||60|0|
72560778|NCT01453153|144651953|SUPERIORITY||percentage of participants|50.0|||||TWO_SIDED|95.0|7.0|93.0||||||||93|7|
72560779|NCT01453153|144651953|SUPERIORITY||percentage of participants|40.0|||||TWO_SIDED|95.0|19.0|64.0||||||||64|19|
72560780|NCT01453153|144651954|SUPERIORITY||percentage of participants|25.0|||||TWO_SIDED|95.0|1.0|81.0||||||||81|1|
72445643|NCT03683719|144406628|SUPERIORITY||Mean Difference (Net)|-15.59|||<|0.01|TWO_SIDED|95.0|-24.82|-6.36||The statistical test was not controlled for multiplicity. Data at visits following premature discont. of IMP or initiation of rescue med. before Week 16 were considered missing and imputed with MMRM predicted values (as were any other missing data).|Mixed Models Analysis|||"Least Square (LS) Means were calculated using a mixed model for repeated measurements on the post-baseline responses up to Week 16 with an unstructured covariance matrix, Kenward-Roger approximation to estimate denominator degrees of freedom, and the mean modelled as follows:~Change from baseline in HECSI~= treatment × visit + baseline HECSI × visit + region + baseline IGA-CHE.~The primary comparison between each active delgocitinib dose and vehicle was at Week 16."||-6.36|-24.82|<0.01
72445644|NCT03683719|144406629|OTHER|Treatment groups were compared using a 2-sided log-rank test stratified by region and baseline IGA-CHE score. An event was defined as the first time achieving IGA-CHE TS.|||||<|0.05||||||"IGA-CHE TS was reached in less than 50% of participants, therefore the median time was not estimable.~The statistical test was not controlled for multiplicity."|Log Rank|||Time to IGA-CHE TS was defined as the time from the date of the first IMP application to first assessment of IGA-CHE TS. Subjects without baseline observation were censored at the date of the first IMP application. Subjects with baseline observation not achieving IGA-CHE TS during the treatment period were censored at the date of the last visit with a valid post-baseline assessment on or prior to the date of discontinuation of IMP or initiation of rescue medication, whichever occurred first.||||<0.05
72445645|NCT03683719|144406629|OTHER|Treatment groups were compared using a 2-sided log-rank test stratified by region and baseline IGA-CHE score. An event was defined as the first time achieving IGA-CHE TS.|||||>|0.1||||||"IGA-CHE TS was reached in less than 50% of participants, therefore the median time was not estimable.~The statistical test was not controlled for multiplicity."|Log Rank|||Time to IGA-CHE TS was defined as the time from the date of the first IMP application to first assessment of IGA-CHE TS. Subjects without baseline observation were censored at the date of the first IMP application. Subjects with baseline observation not achieving IGA-CHE TS during the treatment period were censored at the date of the last visit with a valid post-baseline assessment on or prior to the date of discontinuation of IMP or initiation of rescue medication, whichever occurred first.||||>0.1
72560781|NCT01453153|144651954|SUPERIORITY||percentage of participants|100.0|||||TWO_SIDED|95.0|40.0|100.0||||||||100|40|
72445646|NCT03683719|144406629|OTHER|Treatment groups were compared using a 2-sided log-rank test stratified by region and baseline IGA-CHE score. An event was defined as the first time achieving IGA-CHE TS.|||||<|0.0001||||||The statistical test was not controlled for multiplicity.|Log Rank|||Time to IGA-CHE TS was defined as the time from the date of the first IMP application to first assessment of IGA-CHE TS. Subjects without baseline observation were censored at the date of the first IMP application. Subjects with baseline observation not achieving IGA-CHE TS during the treatment period were censored at the date of the last visit with a valid post-baseline assessment on or prior to the date of discontinuation of IMP or initiation of rescue medication, whichever occurred first.||||<0.0001
72445647|NCT03683719|144406629|OTHER|Treatment groups were compared using a 2-sided log-rank test stratified by region and baseline IGA-CHE score. An event was defined as the first time achieving IGA-CHE TS.|||||<|0.01||||||The statistical test was not controlled for multiplicity.|Log Rank|||Time to IGA-CHE TS was defined as the time from the date of the first IMP application to first assessment of IGA-CHE TS. Subjects without baseline observation were censored at the date of the first IMP application. Subjects with baseline observation not achieving IGA-CHE TS during the treatment period were censored at the date of the last visit with a valid post-baseline assessment on or prior to the date of discontinuation of IMP or initiation of rescue medication, whichever occurred first.||||<0.01
72445648|NCT05081583|144406633|OTHER||AUC ratio (geometric mean)|0.88|||||TWO_SIDED|90.0|0.82|0.96||||||The predefined no effect range was 0.80-1.25; that is, if the geometric mean ratio lay outside this range, a pharmacokinetic interaction was evident.||0.96|0.82|
72445649|NCT05081583|144406634|OTHER|The predefined no effect range was 0.80-1.25; that is, if the geometric mean ratio lay outside this range, a pharmacokinetic interaction was evident.|Cmax ratio (geometric mean)|0.93|||||TWO_SIDED|90.0|0.85|1.01||||||||1.01|0.85|
72445650|NCT05081583|144406635|OTHER||Half-life ratio (geometric mean)|1.01|||||TWO_SIDED|90.0|0.93|1.07||||||||1.07|0.93|
72445651|NCT05081583|144406636|OTHER||Renal clearance ratio (geometric mean)|0.97|||||TWO_SIDED|90.0|0.84|1.12||||||||1.12|0.84|
72445652|NCT05081583|144406637|OTHER||AUC ratio (geometric mean)|0.97|||||TWO_SIDED|90.0|0.81|1.15||||||||1.15|0.81|
72560782|NCT01453153|144651954|SUPERIORITY||percentage of participants|70.0|||||TWO_SIDED|95.0|46.0|88.0||||||||88|46|
72560783|NCT00799708|144651983|SUPERIORITY_OR_OTHER|||||||0.345||95.0|||||ANOVA|||||||0.345
72560784|NCT00799708|144651983|SUPERIORITY_OR_OTHER|||||||0.166||95.0|||||ANOVA|||||||0.166
72560785|NCT00799708|144651984|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.38||||0.12|TWO_SIDED|90.0|-0.16|0.92|||ANCOVA|||||0.92|-0.16|0.120
72560786|NCT00880334|144651985|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.02||||0.939|TWO_SIDED|95.0|0.69|1.49|||Log Rank|||The study was designed with 80% power to detect 60% improvement in median PFS from 18 to 28.8 weeks (Vandetanib+docetaxel/Placebo+docetaxel hazard ratio of 0.625) with the addition of Vandetanib while maintaining an overall significance level of 5% in a one-sided test. This assumed exponential distribution of events, accrual of 1.75 patients per week (7-8 patients per month) for 78 weeks with 34 weeks of additional follow-up (112 weeks total). Full information was 118 PFS events.||1.49|0.69|0.939
72445653|NCT03924986|144406678|OTHER||Hazard Ratio (HR)|0.52|||||TWO_SIDED|95.0|0.38|0.73|||||Estimated using a Cox proportional hazards model with Efron's method for tied events, with Arm B as the reference group. The analysis was stratified by gender and liver metastases status.|The null hypothesis to be tested is that progression-free survival (PFS) in Arm A is less than or equal to PFS in Arm B. This is compared against the alternative hypothesis, which posits that PFS in Arm A is greater than PFS in Arm B.||0.73|0.38|
72445654|NCT03924986|144406679|OTHER||Odds Ratio (OR)|1.85|||||TWO_SIDED|95.0|1.11|3.07|||||||Arm B was the reference group, and the odds ratio between arms was calculated using the Cochran-Mantel-Haenszel chi-square test, stratified by gender and liver metastases status.|3.07|1.11|
72445655|NCT03924986|144406681|OTHER||Hazard Ratio (HR)|0.73|||||TWO_SIDED|95.0|0.51|1.05|||||Estimated using a Cox proportional hazards model with Efron's method for tied events, with Arm B as the reference group. The analysis was stratified by gender and liver metastases status.|||1.05|0.51|
72445656|NCT03924986|144406682|OTHER||Hazard Ratio (HR)|0.54|||||TWO_SIDED|95.0|0.38|0.76|||||Estimated using a Cox proportional hazards model with Efron's method for tied events, with Arm B as the reference group. The analysis was stratified by gender and liver metastases status.|The null hypothesis to be tested is that progression-free survival (PFS) in Arm A is less than or equal to PFS in Arm B. This is compared against the alternative hypothesis, which posits that PFS in Arm A is greater than PFS in Arm B.||0.76|0.38|
72445657|NCT03056040|144406728|NON_INFERIORITY|A difference in percent change in LDH between the ravulizumab and eculizumab treatment groups at Day 183 along with a 2-sided 95% confidence interval (CI) was calculated. Noninferiority margin (NIM) was based on the upper bound of the 95% CI. NIM was 15%.|Treatment Difference|-9.21|||||TWO_SIDED|95.0|-18.84|0.42|||||Treatment difference was estimated for ravulizumab - eculizumab.|Adjusting for a possible 10% dropout rate, a minimum of 192 participants were estimated to provide 90% power to demonstrate noninferiority of ravulizumab to eculizumab.||0.42|-18.84|
72445658|NCT03056040|144406729|NON_INFERIORITY|NIM was based on the upper bound of the 95% CI. NIM was 20%.|Treatment Difference|-5.1|||||TWO_SIDED|95.0|-18.99|8.89|||||Treatment difference was estimated for ravulizumab - eculizumab.|A difference in the percentages of participants with BTH was calculated between the ravulizumab and eculizumab treatment groups, along with a 95% CI for the difference using the stratified Newcombe CI method. The stratification factor observed was transfusion history within 1 year prior to first dose of study drug.||8.89|-18.99|
72445659|NCT03056040|144406730|NON_INFERIORITY|NIM was based on the lower bound of the 95% CI. NIM margin was -3.|Treatment Difference|1.47|||||TWO_SIDED|95.0|-0.21|3.15|||||Treatment difference was estimated for ravulizumab - eculizumab.|||3.15|-0.21|
72445660|NCT03056040|144406731|NON_INFERIORITY|NIM was based on the lower bound of the 95% CI. NIM was -20%.|Treatment Difference|5.5|||||TWO_SIDED|95.0|-4.27|15.68|||||Treatment difference was estimated for ravulizumab - eculizumab.|A difference in the percentages of participants achieving transfusion avoidance was calculated between the ravulizumab and eculizumab treatment groups, along with a 95% CI for the difference using the stratified Newcombe CI method. The stratification factor observed was transfusion history within 1 year prior to first dose of study drug||15.68|-4.27|
72560787|NCT00880334|144651987|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.21||||0.873|TWO_SIDED|95.0|0.81|1.79|||Log Rank|||||1.79|0.81|.873
72560788|NCT00880334|144651988|SUPERIORITY_OR_OTHER|||||||0.56|||||||Fisher Exact|||||||0.56
72560789|NCT00880334|144651989|SUPERIORITY_OR_OTHER|||||||0.31|||||||Fisher Exact|||||||0.31
72560790|NCT02153723|144651996|OTHER|Wilcoxon signed rank sum test|Median Difference (Final Values)|21.6||||0.03|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.03
72560791|NCT02153723|144651997|OTHER|Wilcoxon signed rank sum test|Median Difference (Final Values)|-2.0||||0.03|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.03
72560792|NCT02153723|144651998|OTHER|Wilcoxon signed rank sum test|Median Difference (Final Values)|-0.1||||0.004|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.004
72560793|NCT02153723|144651999|OTHER|Wilcoxon signed rank sum test|Median Difference (Final Values)|15.9||||0.08|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.08
72445661|NCT03056040|144406732|NON_INFERIORITY|NIM was based on the lower bound of the 95% CI. NIM was -20%.|Treatment Difference|1.4|||||TWO_SIDED|95.0|-10.41|13.31|||||Treatment difference was estimated for ravulizumab - eculizumab.|A difference in the percentages of participants with stabilized hemoglobin was calculated between the ravulizumab and eculizumab treatment groups, along with a 95% CI for the difference using the stratified Newcombe CI method. The stratification factor observed was transfusion history within 1 year prior to first dose of study drug.||13.31|-10.41|
72445662|NCT04650087|144406737|SUPERIORITY||Risk Ratio (RR)|0.92|||||TWO_SIDED|95.0|0.44|1.95||||||||1.95|0.44|
72445663|NCT04650087|144406738|SUPERIORITY||Risk Ratio (RR)|1.05|||||TWO_SIDED|95.0|0.83|1.31||||||||1.31|0.83|
72445664|NCT04650087|144406739|SUPERIORITY||Risk Ratio (RR)|0.99|||||TWO_SIDED|95.0|0.78|1.24||||||||1.24|0.78|
72560794|NCT02153723|144652000|OTHER|Wilcoxon signed rank sum test|Mean Difference (Final Values)|0.8||||0.86|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.86
72560795|NCT02153723|144652001|OTHER|Wilcoxon signed rank sum test|Median Difference (Final Values)|0.0||||0.44|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.44
72445665|NCT04650087|144406740|SUPERIORITY||Risk Ratio (RR)|0.88|||||TWO_SIDED|95.0|0.44|1.74||||||||1.74|0.44|
72560796|NCT04968925|144652064|NON_INFERIORITY|A non-inferiority margin of 10% was used.|Odds Ratio (OR)|4.24|||||TWO_SIDED|95.0|0.8|22.54|||Generalized linear Mixed Model Analysis||Odds ratio was calculated as Test over Control|Phase I was not powered to test for non-inferiority for any endpoints. The data collected from this Phase was used to estimate the sample size required to achieve the primary endpoints for Phase II of the study.||22.54|0.80|
72560797|NCT04968925|144652065|NON_INFERIORITY|A non-inferiority margin of 10% was used.|Odds Ratio (OR)|3.44|||||TWO_SIDED|95.0|1.16|10.16|||Generalized linear Mixed Model Analysis||Odds ratio was calculated as Test over Control|Phase I was not powered to test for non-inferiority for any endpoints. The data collected from this Phase was used to estimate the sample size required to achieve the primary endpoints for Phase II of the study.||10.16|1.16|
72560798|NCT04968925|144652066|NON_INFERIORITY|A non-inferiority margin of 10% was used.|Odds Ratio (OR)|2.67|||||TWO_SIDED|95.0|1.05|6.76|||Generalized linear Mixed Model Analysis||Odds ratio was calculated as Test over Control|Phase I was not powered to test for non-inferiority for any endpoints. The data collected from this Phase was used to estimate the sample size required to achieve the primary endpoints for Phase II of the study.||6.76|1.05|
72445666|NCT04650087|144406741|SUPERIORITY||Risk Ratio (RR)|1.11|||||TWO_SIDED|95.0|0.58|2.12||||||||2.12|0.58|
72445667|NCT04650087|144406742|SUPERIORITY||Risk Ratio (RR)|1.0|||||TWO_SIDED|95.0|0.29|3.42||||||||3.42|0.29|
72445668|NCT04650087|144406743|SUPERIORITY||Risk Ratio (RR)|0.33|||||TWO_SIDED|95.0|0.03|3.18||||||||3.18|0.03|
72445669|NCT04650087|144406744|SUPERIORITY||Risk Ratio (RR)|0.88|||||TWO_SIDED|95.0|0.34|2.28||||||||2.28|0.34|
72445670|NCT00450658|144406777|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|9.5||||0.0018|TWO_SIDED|95.0|3.0|15.9|||Cochran-Mantel-Haenszel|CMH test stratified by use of low-dose aspirin (Yes/No) and prior upper gastrointestinal ulcer history (Yes/No) at randomization.||The primary efficacy endpoint was the proportion of subjects developing UGI (gastric and/or duodenal) ulcers throughout 24 weeks of treatment. A summary including cumulative frequency and percentage with associated 95% confidence intervals was produced for the observational incidences of UGI ulcers at 24 weeks. The cumulative proportion of subjects developing UGI ulcers at 24 weeks was analyzed using the CMH test stratified by use of low-dose aspirin and prior UGI ulcer history at randomization.||15.9|3.0|0.0018
72445671|NCT00450658|144406778|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|8.2||||0.0051|TWO_SIDED|95.0|1.9|14.4|||Cochran-Mantel-Haenszel|CMH test stratified by use of low-dose aspirin (Yes/No) and prior upper gastrointestinal ulcer history (Yes/No) at randomization.||||14.4|1.9|0.0051
72445672|NCT00450658|144406779|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|3.9||||0.0017|TWO_SIDED|95.0|0.8|7.1|||Cochran-Mantel-Haenszel|CMH test stratified by use of low-dose aspirin and prior UGI ulcer history at randomization.||The secondary efficacy endpoint was the proportion of subjects developing duodenal ulcers throughout 24 weeks of treatment. A summary including cumulative frequency and percentage with associated 95% confidence intervals was produced for the observational incidences of duodenal ulcers at 24 weeks. The cumulative proportion of subjects developing duodenal ulcers at 24 weeks was analyzed using the CMH test stratified by use of low-dose aspirin and prior UGI ulcer history at randomization.||7.1|0.8|0.0017
72445673|NCT01573442|144406829|SUPERIORITY|||||||0.4952|||||||Wilcoxon (Mann-Whitney)|||||||0.4952
72445674|NCT01573442|144406830|SUPERIORITY|||||||0.2116|||||||Fisher Exact|||||||0.2116
72445675|NCT01573442|144406831|SUPERIORITY|||||||0.676|||||||Wilcoxon (Mann-Whitney)|||||||0.6760
72445676|NCT01573442|144406832|SUPERIORITY|||||||0.029|||||||Wilcoxon (Mann-Whitney)|||From baseline to month 1||||0.029
72445677|NCT01573442|144406832|SUPERIORITY|||||||0.8214|||||||Wilcoxon (Mann-Whitney)|||From baseline to month 2||||0.8214
72445678|NCT01573442|144406832|SUPERIORITY|||||||0.4952|||||||Wilcoxon (Mann-Whitney)|||From baseline to month 3||||0.4952
72445679|NCT01573442|144406832|SUPERIORITY|||||||0.5232|||||||Wilcoxon (Mann-Whitney)|||From baseline to month 4||||0.5232
72445680|NCT01573442|144406832|SUPERIORITY|||||||0.5522|||||||Wilcoxon (Mann-Whitney)|||From baseline to month 5||||0.5522
72445681|NCT01573442|144406832|SUPERIORITY|||||||0.7005|||||||Wilcoxon (Mann-Whitney)|||From baseline to month 6||||0.7005
72445682|NCT01573442|144406836|SUPERIORITY|||||||0.139|||||||Wilcoxon (Mann-Whitney)|||||||0.139
72445683|NCT01573442|144406837|SUPERIORITY|||||||0.8761|||||||Wilcoxon (Mann-Whitney)|||||||0.8761
72445684|NCT01573442|144406838|SUPERIORITY|||||||0.0176|||||||Wilcoxon (Mann-Whitney)|||||||0.0176
72445685|NCT01573442|144406839|SUPERIORITY|||||||0.7077|||||||Wilcoxon (Mann-Whitney)|||||||0.7077
72445686|NCT01573442|144406840|SUPERIORITY|||||||0.8748|||||||Wilcoxon (Mann-Whitney)|||||||0.8748
72445687|NCT01573442|144406841|SUPERIORITY|||||||0.4335|||||||Wilcoxon (Mann-Whitney)|||||||0.4335
72445688|NCT01573442|144406842|SUPERIORITY|||||||0.286|||||||Wilcoxon (Mann-Whitney)|||||||0.286
72445689|NCT01573442|144406843|SUPERIORITY|||||||0.7694|||||||Wilcoxon (Mann-Whitney)|||||||0.7694
72445690|NCT01573442|144406844|SUPERIORITY|||||||0.9609|||||||Wilcoxon (Mann-Whitney)|||||||0.9609
72445691|NCT04055090|144406853|OTHER||Least Square Mean Difference|-0.89|STANDARD_ERROR_OF_MEAN|0.438||0.046|TWO_SIDED|95.0|-1.76|-0.02|||Mixed Models Analysis|Mixed-effects Model for Repeated Measures (MMRM) with treatment, visit, treatment-by-visit, and use of gabapentin/pregabalin as main fixed effects|Mixed-effects Model for Repeated Measures with treatment, visit, treatment-by-visit, and use of gabapentin/pregabalin as main fixed effects. The Baseline average 24-hour pain score was included as a covariate.|||-0.02|-1.76|0.0460
72445692|NCT04055090|144406855|OTHER|||||||0.219|||||||Cochran-Mantel-Haenszel|||||||0.2190
72445693|NCT04055090|144406856|OTHER||Least-Squares Mean Difference|-1.48||||0.0155|TWO_SIDED|95.0|-2.67|-0.29|||Mixed Models Analysis||Mixed-effects Model for Repeated Measures (MMRM) with treatment, visit, treatment-by-visit, and use of gabapentin/pregabalin as main fixed effects. Baseline average 24-hour pain score is included as a covariate.|||-0.29|-2.67|0.0155
72445694|NCT05071807|144406857|SUPERIORITY||Mean Difference (Net)|0.08|||||TWO_SIDED|95.0|-1.17|1.33|||Regression, Linear|adjusted for outcome baseline value, age (years), sex (male or female) and BMI (kg/m2)||To detect a 1.2 percentage point (standard deviation 2.4; effect size 0.5) between-group difference in the change in FMD with 80% power (α=0.05), it was estimated that a sample size of 128 participants was needed (64 per group)||1.33|-1.17|
72445695|NCT05071807|144406858|SUPERIORITY||Mean Difference (Net)|-7.2|||||TWO_SIDED|95.0|-12.3|-2.1|||Regression, Linear|adjusted for outcome baseline value, age (years), sex (male or female) and baseline BMI (kg/m2)||||-2.1|-12.3|
72445696|NCT05071807|144406859|SUPERIORITY||Mean Difference (Net)|1.1|||||TWO_SIDED|95.0|-0.8|2.9|||Regression, Linear|adjusted for outcome baseline value, age (years), sex (male or female) and baseline BMI (kg/m2)||||2.9|-0.8|
72445697|NCT05071807|144406860|SUPERIORITY||Mean Difference (Net)|-16.4|||||TWO_SIDED|95.0|-30.0|-2.9|||Regression, Linear|adjusted for outcome baseline value, age (years), sex (male or female) and baseline BMI (kg/m2)||||-2.9|-30.0|
72445698|NCT05071807|144406861|SUPERIORITY||Mean Difference (Net)|-75.3|||||TWO_SIDED|95.0|-144.0|-6.93|||Regression, Linear|adjusted for outcome baseline value, age (years), sex (male or female) and baseline BMI (kg/m2)||Total LDL particle mean difference||-6.93|-144|
72445699|NCT05071807|144406861|SUPERIORITY||Mean Difference (Net)|-27.9|||||TWO_SIDED|95.0|-69.3|13.4|||Regression, Linear|adjustment for the baseline value, age (years), sex (male or female) and body mass index (BMI) (kg/m2)||For Large LDL particle subclass||13.4|-69.3|
72445700|NCT05071807|144406862|SUPERIORITY||Mean Difference (Net)|0.1|||||TWO_SIDED|95.0|-0.56|0.75|||Regression, Linear|adjusted for outcome baseline value, age (years), sex (male or female) and baseline BMI (kg/m2).||Results for total HDL particle count||0.75|-0.56|
72445701|NCT05071807|144406862|SUPERIORITY||Mean Difference (Net)|0.03|||||TWO_SIDED|95.0|-0.75|0.8||||Adjusted for baseline value, age, sex, and BMI||Results for Small HDL particles||0.80|-0.75|
72395163|NCT03978520|144296912|SUPERIORITY||Response Rate Difference|14.7|||=|0.049|TWO_SIDED|95.0|0.0|29.4|||Cochran-Mantel-Haenszel|||"ABBV-599 High Dose (Elsubrutinib 60 mg/upadacitinib 30 mg) vs elsubrutinib placebo/upadacitinib placebo~The difference between the groups was assessed using the Cochran-Mantel-Haenszel (CMH) test, stratified by baseline corticosteroid dose above 10 mg prednisone-equivalent (≤10 mg or \> 10 mg), screening SLEDAI-2K (\< 10 or ≥10), baseline interferon score (high or low or NA), baseline immunosuppressant (azathioprine, tacrolimus, cyclosporine, methotrexate \[MTX\], mycophenolate) (yes or no)."||29.4|0.0|=0.049
72395164|NCT03978520|144296912|SUPERIORITY||Response Rate Difference|13.9|||=|0.091|TWO_SIDED|95.0|-2.2|30.1|||Cochran-Mantel-Haenszel|||"Elsubrutinib placebo/upadacitinib 30 mg vs elsubrutinib placebo/upadacitinib placebo~The difference between the groups was assessed using the Cochran-Mantel-Haenszel (CMH) test, stratified by baseline corticosteroid dose above 10 mg prednisone-equivalent (≤10 mg or \> 10 mg), screening SLEDAI-2K (\< 10 or ≥10), baseline interferon score (high or low or NA), baseline immunosuppressant (azathioprine, tacrolimus, cyclosporine, methotrexate \[MTX\], mycophenolate) (yes or no)."||30.1|-2.2|=0.091
72395165|NCT03978520|144296912|SUPERIORITY||Response Rate Difference|-6.3|||=|0.447|TWO_SIDED|95.0|-22.5|9.9|||Cochran-Mantel-Haenszel|||"ABBV-599 High Dose (Elsubrutinib 60 mg/upadacitinib 30 mg) vs Elsubrutinib placebo/upadacitinib 30 mg~The difference between the groups was assessed using the Cochran-Mantel-Haenszel (CMH) test, stratified by baseline corticosteroid dose above 10 mg prednisone-equivalent (≤10 mg or \> 10 mg), screening SLEDAI-2K (\< 10 or ≥10), baseline interferon score (high or low or NA), baseline immunosuppressant (azathioprine, tacrolimus, cyclosporine, methotrexate \[MTX\], mycophenolate) (yes or no)."||9.9|-22.5|=0.447
72395166|NCT03978520|144296913|SUPERIORITY||Response Rate Difference|16.7|||=|0.007|TWO_SIDED|95.0|4.5|28.9|||Cochran-Mantel-Haenszel|||"ABBV-599 High Dose (Elsubrutinib 60 mg/upadacitinib 30 mg) vs elsubrutinib placebo/upadacitinib placebo~The difference between the groups was assessed using the Cochran-Mantel-Haenszel (CMH) test, stratified by baseline corticosteroid dose above 10 mg prednisone-equivalent (≤10 mg or \> 10 mg), screening SLEDAI-2K (\< 10 or ≥10), baseline interferon score (high or low or NA), baseline immunosuppressant (azathioprine, tacrolimus, cyclosporine, methotrexate \[MTX\], mycophenolate) (yes or no)."||28.9|4.5|=0.007
72395167|NCT03978520|144296913|SUPERIORITY||Response Rate Difference|31.0|||<|0.001|TWO_SIDED|95.0|18.1|44.0|||Cochran-Mantel-Haenszel|||Elsubrutinib placebo/upadacitinib 30 mg vs elsubrutinib placebo/upadacitinib placebo||44.0|18.1|<0.001
72395168|NCT03978520|144296913|SUPERIORITY||Response Rate Difference|-13.7|||=|0.068|TWO_SIDED|95.0|-28.4|1.0|||Cochran-Mantel-Haenszel|||"ABBV-599 High Dose (Elsubrutinib 60 mg/upadacitinib 30 mg) vs elsubrutinib placebo/upadacitinib 30 mg~The difference between the groups was assessed using the Cochran-Mantel-Haenszel (CMH) test, stratified by baseline corticosteroid dose above 10 mg prednisone-equivalent (≤10 mg or \> 10 mg), screening SLEDAI-2K (\< 10 or ≥10), baseline interferon score (high or low or NA), baseline immunosuppressant (azathioprine, tacrolimus, cyclosporine, methotrexate \[MTX\], mycophenolate) (yes or no)."||1.0|-28.4|=0.068
72395169|NCT03978520|144296914|SUPERIORITY||LS Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|0.527|=|0.71|TWO_SIDED|95.0|-0.84|1.23|||Mixed-effect model repeat measurement|||"ABBV-599 High Dose (Elsubrutinib 60 mg/upadacitinib 30 mg) vs elsubrutinib placebo/upadacitinib placebo~The Mixed-Effect Model Repeat Measurement model included fixed effects of Tx, visit and Tx-by-visit interaction, stratification factors (Baseline corticosteroid dose \> 10 mg prednisone-equivalent (≤ 10 mg or \>10 mg), screening SLEDAI-2K (\<10 or ≥ 10), baseline interferon score (high/low/NA, baseline immunosuppressant (yes/no)), and continuous fixed covariates of measurements at Baseline."||1.23|-0.84|=0.710
72395170|NCT03978520|144296914|SUPERIORITY||LS Mean Difference|0.03|STANDARD_ERROR_OF_MEAN|0.545|=|0.963|TWO_SIDED|95.0|-1.05|1.1|||Mixed-effect model repeat measurement|||"Elsubrutinib placebo/upadacitinib 30 mg vs elsubrutinib placebo/upadacitinib placebo~The Mixed-Effect Model Repeat Measurement model included fixed effects of Tx, visit and Tx-by-visit interaction, stratification factors (Baseline corticosteroid dose \> 10 mg prednisone-equivalent (≤ 10 mg or \>10 mg), screening SLEDAI-2K (\<10 or ≥ 10), baseline interferon score (high/low/NA, baseline immunosuppressant (yes/no)), and continuous fixed covariates of measurements at Baseline."||1.10|-1.05|=0.963
72395171|NCT03978520|144296914|SUPERIORITY||LS Mean Difference|0.17|STANDARD_ERROR_OF_MEAN|0.547|=|0.754|TWO_SIDED|95.0|-0.9|1.25|||Mixed-effect model repeat measurement|||"ABBV-599 High Dose (Elsubrutinib 60 mg/upadacitinib 30 mg) vs elsubrutinib placebo/upadacitinib 30 mg~The Mixed-Effect Model Repeat Measurement model included fixed effects of Tx, visit and Tx-by-visit interaction, stratification factors (Baseline corticosteroid dose \> 10 mg prednisone-equivalent (≤ 10 mg or \>10 mg), screening SLEDAI-2K (\<10 or ≥ 10), baseline interferon score (high/low/NA, baseline immunosuppressant (yes/no)), and continuous fixed covariates of measurements at Baseline."||1.25|-0.90|=0.754
72395172|NCT03978520|144296915|SUPERIORITY||Rate difference|-1.06|||=|0.002|TWO_SIDED|95.0|-1.74|-0.39|||Binomial regression|||"Mild/Moderate~ABBV-599 High Dose (Elsubrutinib 60 mg/upadacitinib 30 mg) vs Elsubrutinib placebo/upadacitinib placebo~A negative binomial regression model was used to assess treatment effect with treatment, visit, and stratification factors as covariates."||-0.39|-1.74|=0.002
72395173|NCT03978520|144296915|SUPERIORITY||Rate Difference|-0.69|||=|0.059|TWO_SIDED|95.0|-1.41|0.03|||Binomial regression|||"Mild/Moderate~Elsubrutinib placebo/upadacitinib 30 mg vs elsubrutinib placebo/upadacitinib placebo~A negative binomial regression model was used to assess treatment effect with treatment, visit, and stratification factors as covariates."||0.03|-1.41|=0.059
72395174|NCT03978520|144296915|SUPERIORITY||Rate Difference|-0.37|||=|0.252|TWO_SIDED|95.0|-1.01|0.27|||Binomial regression|||"Mild/Moderate~ABBV-599 High Dose (Elsubrutinib 60 mg/upadacitinib 30 mg) vs elsubrutinib placebo/upadacitinib 30 mg~A negative binomial regression model was used to assess treatment effect with treatment, visit, and stratification factors as covariates."||0.27|-1.01|=0.252
72395175|NCT03978520|144296915|SUPERIORITY||Rate Difference|-0.1|||=|0.467|TWO_SIDED|95.0|-0.37|0.17|||Binomial regression|||"Severe~ABBV-599 High Dose (Elsubrutinib 60 mg/upadacitinib 30 mg) vs elsubrutinib placebo/upadacitinib placebo~A negative binomial regression model was used to assess treatment effect with treatment, visit, and stratification factors as covariates."||0.17|-0.37|=0.467
72395176|NCT03978520|144296915|SUPERIORITY||Rate Difference|-0.26|||=|0.033|TWO_SIDED|95.0|-0.49|-0.02|||Binomial regression|||"Severe~Elsubrutinib placebo/upadacitinib 30 mg vs elsubrutinib placebo/upadacitinib placebo~A negative binomial regression model was used to assess treatment effect with treatment, visit, and stratification factors as covariates."||-0.02|-0.49|=0.033
72619301|NCT01654250|144769242|SUPERIORITY_OR_OTHER||LS Mean Difference|34.7|STANDARD_ERROR_OF_MEAN|11.12||0.002|TWO_SIDED|95.0|12.8|56.6|||Mixed Models Analysis|||Hour 4 post-dose (Problems attempted): Treatment comparisons for observed scores were assessed using a mixed model repeated measures analysis, with treatment (NWP09/Placebo), study center, time point and time point by treatment interaction as main effects and participant intercept as a random effect.||56.6|12.8|0.002
72445702|NCT05071807|144406862|SUPERIORITY||Mean Difference (Net)|-0.33|||||TWO_SIDED|95.0|-0.85|0.19|||Regression, Linear|Adjusted for baseline value, age, sex, and BMI||Results for Medium HDL||0.19|-0.85|
72445703|NCT05071807|144406863|SUPERIORITY||Mean Difference (Final Values)|0.02|||||TWO_SIDED|95.0|-3.09|3.13|||Regression, Linear|were adjusted for outcome baseline value, age (years), sex (male or female) and baseline BMI (kg/m2)||Results from brachial systolic blood pressure are reported below||3.13|-3.09|
72445704|NCT05071807|144406863|SUPERIORITY||Mean Difference (Net)|0.2|||||TWO_SIDED|95.0|-1.67|2.07|||Regression, Linear|Adjusted for baseline value, age, sex, BMI||Results for Brachial Diastolic Blood pressure||2.07|-1.67|
72560799|NCT04968925|144652067|SUPERIORITY|"The Fallback Method was used to test primary hypotheses in Phase II. An alpha of 0.167 was allocated for each test. Every successful test passed the unused alpha to the next."|Odds Ratio (OR)|1.76|||||TWO_SIDED|98.33|1.09|2.83|||Generalized linear Mixed Model Analysis||Odds ratio was calculated as Test over Control|It was calculated based on Phase I using Stroup's Method that 200 subjects were required to test superiority for each endpoint in Phase II.||2.83|1.09|
72445705|NCT05071807|144406864|SUPERIORITY||Mean Difference (Net)|-0.48|||||TWO_SIDED|95.0|-3.24|2.28|||Regression, Linear|Adjusted for baseline value, age, sex, BMI||Results for central systolic blood pressure||2.28|-3.24|
72445706|NCT05071807|144406864|SUPERIORITY||Median Difference (Net)|0.21|||||TWO_SIDED|95.0|-1.69|2.1|||Regression, Linear|Adjusted for baseline value, age, sex, BMI||Results for central diastolic blood pressure||2.10|-1.69|
72560800|NCT04968925|144652068|SUPERIORITY|"The Fallback Method was used to test primary hypotheses in Phase II. An alpha of 0.167 was allocated for each test. Every successful test passed the unused alpha to the next."|Odds Ratio (OR)|1.52|||||TWO_SIDED|96.66|1.02|2.28|||Generalized linear Mixed Model Analysis||Odds ratio was calculated as Test over Control|It was calculated based on Phase I using Stroup's Method that 200 subjects were required to test superiority for each endpoint in Phase II.||2.28|1.02|
72560801|NCT04968925|144652069|SUPERIORITY|"The Fallback Method was used to test primary hypotheses in Phase II. An alpha of 0.167 was allocated for each test. Every successful test passed the unused alpha to the next."|Odds Ratio (OR)|1.25|||||TWO_SIDED|95.0|0.77|2.03|||Generalized linear Mixed Model Analysis||Odds ratio was calculated as Test over Control|It was calculated based on Phase I using Stroup's Method that 200 subjects were required to test superiority for each endpoint in Phase II.||2.03|0.77|
72560802|NCT00876265|144652081|NON_INFERIORITY_OR_EQUIVALENCE|If the 95% CI or the difference between LS mean (Belotero) and LS mean (Zyplast) lies entirely above -Δ, noninferiority of Belotero will be concluded (first step). If, in addition, the CI lies entirely above 0, superiority of Belotero over Zyplast will be concluded (second step).|Adjusted (LS) mean difference|0.048|STANDARD_ERROR_OF_MEAN|0.139||0.733|TWO_SIDED|95.0|-0.228|0.323||Treatment term and all significant (p ≤ 0.10) covariate and covariate by treatment interactions will be retained in the final ANCOVA model. From the final ANCOVA model, adjusted (LS) means for Belotero and Zyplast was computed.|ANCOVA|||"The null, H0, and the alternative hypothesis, H1, are as follows:~H0(1): adjusted mean(dadj\[i\]) ≤ -Δ versus H1(1): adjusted mean(dadj\[i\]) \> -Δ H0(2): adjusted mean(dadj\[i\]) ≤ 0 versus H1(2): adjusted mean(dadj\[i\]) \> 0 The sample size calculation was based on the following assumptions: Type I error α = 0.025 (one sided); Power = 90%; Non-inferiority margin Δ = 0.25; Estimated common standard deviation (SD) = 0.75. Under these assumptions, a total of 100 evaluable subjects were needed."||0.323|-0.228|0.733
72560803|NCT00487695|144652082|SUPERIORITY_OR_OTHER_LEGACY|||||||0.01|TWO_SIDED|95.0|||||Wilcoxon signed rank|||Our hypothesis was that the yield for neoplasia would be higher using confocal laser endomicroscopy compared to standard endoscopy. The null hypothesis would be that there is no difference in yield for neoplasia when CLE is used compared to standard endoscopy. We estimated that the yield for neoplasia would increase from 10% to 40% using CLE and the calculated sample size was 37. We planned to enroll 48 patients to allow for possible dropouts.||||0.01
72560804|NCT00487695|144652083|SUPERIORITY_OR_OTHER_LEGACY|||||||0.89||95.0|||||Wilcoxon signed-rank|||The number of biopsies showing neoplasia was determined for each procedure (confocal laser endomicroscopy, standard EGD). These were compared.||||0.89
72619302|NCT01654250|144769242|SUPERIORITY_OR_OTHER||LS Mean Difference|29.3|STANDARD_ERROR_OF_MEAN|11.12||0.009|TWO_SIDED|95.0|7.4|51.1|||Mixed Models Analysis|||Hour 8 post-dose (Problems attempted): Treatment comparisons for observed scores were assessed using a mixed model repeated measures analysis, with treatment (NWP09/Placebo), study center, time point and time point by treatment interaction as main effects and participant intercept as a random effect.||51.1|7.4|0.009
72395177|NCT03978520|144296915|SUPERIORITY||Rate Difference|0.15|||=|0.156|TWO_SIDED|95.0|-0.06|0.37|||Binomial regression|||"Severe~ABBV-599 High Dose (Elsubrutinib 60 mg/upadacitinib 30 mg) vs elsubrutinib placebo/upadacitinib 30 mg~A negative binomial regression model was used to assess treatment effect with treatment, visit, and stratification factors as covariates."||0.37|-0.06|=0.156
72395178|NCT03978520|144296915|SUPERIORITY||Rate Difference|-1.16|||=|0.002|TWO_SIDED|95.0|-1.89|-0.44|||Binomial regression|||"Overall~ABBV-599 High Dose (Elsubrutinib 60 mg/upadacitinib 30 mg) vs elsubrutinib placebo/upadacitinib placebo~A negative binomial regression model was used to assess treatment effect with treatment, visit, and stratification factors as covariates."||-0.44|-1.89|=0.002
72395179|NCT03978520|144296915|SUPERIORITY||Rate Difference|-0.95|||=|0.014|TWO_SIDED|95.0|-1.7|-0.19|||Binomial regression|||"Overall~Elsubrutinib placebo/upadacitinib 30 mg vs elsubrutinib placebo/upadacitinib placebo~A negative binomial regression model was used to assess treatment effect with treatment, visit, and stratification factors as covariates."||-0.19|-1.70|=0.014
72395180|NCT03978520|144296915|SUPERIORITY||Rate Difference|-0.22|||=|0.526|TWO_SIDED|95.0|-0.89|0.46|||Binomial regression|||"Overall~ABBV-599 High Dose (Elsubrutinib 60 mg/upadacitinib 30 mg) vs elsubrutinib placebo/upadacitinib 30 mg~A negative binomial regression model was used to assess treatment effect with treatment, visit, and stratification factors as covariates."||0.46|-0.89|=0.526
72395181|NCT03918447|144296977|SUPERIORITY||Least Square Means Difference|0.97|STANDARD_ERROR_OF_MEAN|1.122|=|0.3886|TWO_SIDED|95.0|-1.25|3.19|||ANCOVA|||ANCOVA model with baseline eGFR as a covariate, and treatment group as fixed effects.||3.19|-1.25|=0.3886
72445707|NCT05071807|144406865|SUPERIORITY||Mean Difference (Net)|-0.01|||||TWO_SIDED|95.0|-0.26|0.24|||Regression, Linear|were adjusted for outcome baseline value, age (years), sex (male or female) and baseline BMI (kg/m2)||||0.24|-0.26|
72445708|NCT05071807|144406866|SUPERIORITY||Mean Difference (Net)|-1.65|||||TWO_SIDED|95.0|-4.25|0.95|||Regression, Linear|adjusted for outcome baseline value, age (years), sex (male or female) and baseline BMI (kg/m2)||||0.95|-4.25|
72445709|NCT05071807|144406867|SUPERIORITY||Mean Difference (Net)|1.2|||||TWO_SIDED|95.0|-0.6|3.0|||Regression, Linear|adjusted for outcome baseline value, age (years), sex (male or female) and baseline BMI (kg/m2)||||3.0|-0.6|
72445710|NCT05071807|144406868|SUPERIORITY||Mean Difference (Net)|-0.4|||||TWO_SIDED|95.0|-2.3|1.6|||Regression, Linear|adjusted for outcome baseline value, age (years), sex (male or female) and baseline BMI (kg/m2).||||1.6|-2.3|
72445711|NCT05071807|144406869|SUPERIORITY||Mean Difference (Net)|0.0|||||TWO_SIDED|95.0|0.0|0.1|||Regression, Linear|adjusted for outcome baseline value, age (years), sex (male or female) and baseline BMI (kg/m2).||||0.1|0.0|
72445712|NCT05071807|144406870|SUPERIORITY||Mean Difference (Net)|9.4|||||TWO_SIDED|95.0|5.0|13.7||When a significant group by time point interaction was detected, post hoc testing was conducted and the Tukey-Kramer method was used to adjust for multiple comparisons.|Mixed Models Analysis|adjusted for outcome baseline value, age (years), sex (male or female) and baseline BMI (kg/m2).||||13.7|5.0|
72445713|NCT05071807|144406871|SUPERIORITY||Median Difference (Net)|-8.1|||||TWO_SIDED|95.0|-14.5|-1.7|||Regression, Linear|adjusted for outcome baseline value, age (years), sex (male or female) and baseline BMI (kg/m2)||||-1.7|-14.5|
72445714|NCT05071807|144406872|SUPERIORITY||Mean Difference (Net)|-25.5|||||TWO_SIDED|95.0|-98.6|47.5|||Regression, Linear|adjusted for outcome baseline value, age (years), sex (male or female) and baseline BMI (kg/m2)||Results for medium subclass; Measure Description: LDL particle size classifications are as follows: 22-25.5 nm is small, 25.6-26.5 nm medium, and 26.6-28.5 nm large. Typically, smaller LDL is associated with increased cardiovascular risk compared to larger.||47.5|-98.6|
72445715|NCT05071807|144406872|SUPERIORITY||Mean Difference (Net)|1.86|||||TWO_SIDED|95.0|-91.8|95.5|||Regression, Linear|adjustment for the baseline value, age (years), sex (male or female) and body mass index (BMI) (kg/m2)||Results for Small LDL particles; Measure Description: LDL particle size classifications are as follows: 22-25.5 nm is small, 25.6-26.5 nm medium, and 26.6-28.5 nm large. Typically, smaller LDL is associated with increased cardiovascular risk compared to larger.||95.5|-91.8|
72445716|NCT05071807|144406873|SUPERIORITY||Mean Difference (Net)|0.35|||||TWO_SIDED|95.0|0.07|0.63|||Regression, Linear|adjusted for outcome baseline value, age (years), sex (male or female) and baseline BMI (kg/m2).||||0.63|0.07|
72619303|NCT01654250|144769242|SUPERIORITY_OR_OTHER||LS Mean Difference|12.5|STANDARD_ERROR_OF_MEAN|11.12||0.261|TWO_SIDED|95.0|-9.3|34.4|||Mixed Models Analysis|||Hour 10 post-dose (Problems attempted): Treatment comparisons for observed scores were assessed using a mixed model repeated measures analysis, with treatment (NWP09/Placebo), study center, time point and time point by treatment interaction as main effects and participant intercept as a random effect.||34.4|-9.3|0.261
72445717|NCT02754882|144406883|EQUIVALENCE|Pre-defined equivalence margin was \[0.737, 1.357\]|Risk Ratio (RR)|1.11|||||TWO_SIDED|90.0|0.975|1.269|||||SB8 vs. Avastin|||1.269|0.975|
72445718|NCT04648033|144406893|OTHER||Probability of DLT at dose level 4|0.116|||||TWO_SIDED|95.0|0.032|0.26||||||The primary analysis is performed using the Time-To-Event Continual Reassessment Method (TiTE-CRM). Giving posterior estimates for the probability of toxicity (DLT) at each dose level.||0.26|0.032|
72445719|NCT05324124|144406905|OTHER||Ratio of Geometric Least Squares Mean|0.952|||||TWO_SIDED|90.0|0.876|1.03||||||||1.03|0.876|
72445720|NCT05324124|144406906|OTHER||Ratio of Geometric Least Squares Mean|0.949|||||TWO_SIDED|90.0|0.869|1.04||||||||1.04|0.869|
72445721|NCT05324124|144406907|OTHER||Ratio of Geometric Least Squares Mean|0.829|||||TWO_SIDED|90.0|0.744|0.925||||||||0.925|0.744|
72445722|NCT03771898|144406983|SUPERIORITY|Survival probability free of loss of locomotion estimated up to Week 106 (or two years).|Difference in survival probability (%)|-2.2|||=|0.585|TWO_SIDED|95.0|-22.2|17.7||One-sided, over time intervals during entire follow-up. Stratified generalized log-rank test was used, where matching identification created from matching process in SAS PSMATCH Procedure used as strata.|Log Rank||For the shared time interval up to Week 106 (or two years).|Interval censoring survival analysis.||17.7|-22.2|=0.585
72445723|NCT05563246|144407010|SUPERIORITY||LS Mean Difference (Final Values)|-47.61|||<|0.001|TWO_SIDED|95.0|-57.68|-35.14|||Mixed Models Analysis|||||-35.14|-57.68|<.001
72445724|NCT05563246|144407010|SUPERIORITY||LS Mean Difference (Final Values)|-81.66|||<|0.001|TWO_SIDED|95.0|-84.62|-78.13|||Mixed Models Analysis|||||-78.13|-84.62|<.001
72445725|NCT05563246|144407010|SUPERIORITY||LS Mean Difference (Final Values)|-85.77|||<|0.001|TWO_SIDED|95.0|-88.03|-83.09|||Mixed Models Analysis|||||-83.09|-88.03|<.001
72445726|NCT05563246|144407011|SUPERIORITY||LS Mean Difference (Final Values)|-40.38|||<|0.001|TWO_SIDED|95.0|-50.45|-28.27|||Mixed Models Analysis|||||-28.27|-50.45|<.001
72445727|NCT05563246|144407011|SUPERIORITY||LS Mean Difference (Final Values)|-69.95|||<|0.001|TWO_SIDED|95.0|-74.23|-64.96|||Mixed Models Analysis|||||-64.96|-74.23|<.001
72445728|NCT05563246|144407011|SUPERIORITY||LS Mean Difference (Final Values)|-68.9|||<|0.001|TWO_SIDED|95.0|-73.27|-63.81|||Mixed Models Analysis|||||-63.81|-73.27|<.001
72445729|NCT05563246|144407012|SUPERIORITY||Risk Difference (RD)|58.15|||<|0.001|TWO_SIDED|95.0|40.3|75.99|||Regression, Logistic|||||75.99|40.30|<.001
72445730|NCT05563246|144407012|SUPERIORITY||Risk Difference (RD)|89.87|||<|0.001|TWO_SIDED|95.0|81.54|98.2|||Regression, Logistic|||||98.20|81.54|<.001
72445731|NCT05563246|144407012|SUPERIORITY||Risk Difference (RD)|90.71|||<|0.001|TWO_SIDED|95.0|82.8|98.62|||Regression, Logistic|||||98.62|82.80|<.001
72445732|NCT05563246|144407013|SUPERIORITY||Risk Difference (RD)|35.18|||<|0.001|TWO_SIDED|95.0|18.9|51.46|||Regression, Logistic|||||51.46|18.90|<.001
72445733|NCT05563246|144407013|SUPERIORITY||Risk Difference (RD)|78.18|||<|0.001|TWO_SIDED|95.0|67.7|88.65|||Regression, Logistic|||||88.65|67.70|<.001
72445734|NCT05563246|144407013|SUPERIORITY||Risk Difference (RD)|73.62|||<|0.001|TWO_SIDED|95.0|63.65|83.58|||Regression, Logistic|||||83.58|63.65|<.001
72445735|NCT05563246|144407014|SUPERIORITY||LS Mean Difference (Final Values)|-8.94||||0.11|TWO_SIDED|95.0|-18.84|2.17|||Mixed Models Analysis|||||2.17|-18.84|0.110
72445736|NCT05563246|144407014|SUPERIORITY||LS Mean Difference (Final Values)|-13.05||||0.004|TWO_SIDED|95.0|-20.92|-4.4|||Mixed Models Analysis|||||-4.40|-20.92|0.004
72445737|NCT05563246|144407014|SUPERIORITY||LS Mean Difference (Final Values)|-16.13|||<|0.001|TWO_SIDED|95.0|-23.69|-7.84|||Mixed Models Analysis|||||-7.84|-23.69|<.001
72445738|NCT05563246|144407015|SUPERIORITY||LS Mean Difference (Final Values)|35.27||||0.131|TWO_SIDED|95.0|-8.63|100.27|||Mixed Models Analysis|||||100.27|-8.63|0.131
72445739|NCT05563246|144407015|SUPERIORITY||LS Mean Difference (Final Values)|8.32||||0.627|TWO_SIDED|95.0|-21.62|49.7|||Mixed Models Analysis|||||49.70|-21.62|0.627
72445740|NCT05563246|144407015|SUPERIORITY||LS Mean Difference (Final Values)|-6.08||||0.701|TWO_SIDED|95.0|-31.89|29.51|||Mixed Models Analysis|||||29.51|-31.89|0.701
72445741|NCT02167867|144407019|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||t-test, 2 sided|||t=+7.76||||<0.0001
72445742|NCT04927065|144407023|OTHER||Geometric Mean Ratio (GMR)|2.5|||||TWO_SIDED|95.0|2.0|3.0|||||Omicron BA.1 Variant (B.1.1.529) nAB: Part A.2 versus Part A.1|||3.0|2.0|
72445743|NCT04927065|144407023|OTHER||GMR|2.0|||||TWO_SIDED|95.0|1.7|2.3|||||SARS-CoV-2 (D614G) nAb: Part A.2 versus Part A.1|||2.3|1.7|
72445744|NCT04927065|144407024|OTHER||Geometric Mean Ratio (GMR)|6.3|||||TWO_SIDED|95.0|4.5|8.9|||||Omicron BA.1 Variant (B.1.1.529) nAb: Part A.2 versus Part A.1|||8.9|4.5|
72560805|NCT00487695|144652084|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002||95.0|||||wilcoxon signed rank test|||The null hypothesis would be that CLE does not decrease the number of biopsies needed to make a diagnosis compared to standard endoscopy||||0.002
72445745|NCT04927065|144407024|OTHER||GMR|2.8|||||TWO_SIDED|95.0|2.1|3.6|||||SARS-CoV-2 (D614G) nAb: Part A.2 versus Part A.1|||3.6|2.1|
72560806|NCT00487695|144652086|SUPERIORITY_OR_OTHER_LEGACY|||||||1||95.0|||||Wilcoxon signed-rank|||The number of biopsies showing neoplasia was determined for each procedure (confocal laser endomicroscopy, standard EGD). These were compared. This analysis looks at the patients referred for Barrett's surveillance EGD (no suspected neoplasia).||||1.0
72560807|NCT00487695|144652087|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||Wilcoxon signed-rank|||The null hypothesis would be that CLE does not decrease the number of biopsies needed to make a diagnosis compared to standard endoscopy||||<0.0001
72560808|NCT01957150|144652092|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of 95 % confidence interval (CI) for the overall treatment difference change from Baseline between FF/VI and VI was greater than -1 % year|Percentage Change from Baseline|-0.46|||||TWO_SIDED|95.0|-0.97|0.06|||||Treatment comparison for overall weeks|||0.06|-0.97|
72560809|NCT01957150|144652093|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of 95% CI for the overall treatment difference change from Baseline between FF/VI and VI was greater than -1 % year|Percentage Change from Baseline|-0.47|||||TWO_SIDED|95.0|-1.17|0.24|||||Overall Weeks for Male|||0.24|-1.17|
72619304|NCT01654250|144769242|SUPERIORITY_OR_OTHER||LS Mean Difference|15.1|STANDARD_ERROR_OF_MEAN|11.12||0.175|TWO_SIDED|95.0|-6.7|37.0|||Mixed Models Analysis|||Hour 12 post-dose (Problems attempted): Treatment comparisons for observed scores were assessed using a mixed model repeated measures analysis, with treatment (NWP09/Placebo), study center, time point and time point by treatment interaction as main effects and participant intercept as a random effect.||37.0|-6.7|0.175
72445746|NCT04927065|144407025|OTHER||Percentage Difference|1.3|||||TWO_SIDED|95.0|-3.1|5.6|||||Omicron BA.1 Variant (B.1.1.529) nAb: Part A.2 versus Part A.1|||5.6|-3.1|
72445747|NCT04927065|144407025|OTHER||Percentage Difference|0.0|||||TWO_SIDED|95.0|||||||SARS-CoV-2 (D614G) nAb: Part A.2 versus Part A.1|||||
72445748|NCT04927065|144407026|OTHER||Percentage Difference|-1.3|||||TWO_SIDED|95.0|-6.9|4.3|||||Omicron variant (B.1.1.529) nAb: Part A.2 versus Part A.1|||4.3|-6.9|
72445749|NCT04927065|144407026|OTHER||Percentage Difference|-2.6|||||TWO_SIDED|95.0|-9.6|4.5|||||SARS-CoV-2 (D614G) nAb: Part A.2 versus Part A.1|||4.5|-9.6|
72445750|NCT04927065|144407027|OTHER||Percentage Difference|12.9|||||TWO_SIDED|95.0|4.1|21.6|||||Omicron BA.1 variant (B.1.1.529) nAb: Part A.2 versus Part A.1|||21.6|4.1|
72445751|NCT04927065|144407027|OTHER||Percentage Difference|0.0|||||TWO_SIDED|95.0|||||||SARS-CoV-2 (D614G) nAb: Part A.2 versus Part A.1|||||
72445752|NCT04927065|144407028|OTHER||Percentage Difference|2.9|||||TWO_SIDED|95.0|-11.4|17.1|||||Omicron BA.1 variant (B.1.1.529) nAb: Part A.2 versus Part A.1|||17.1|-11.4|
72445753|NCT04927065|144407028|OTHER||Percentage Difference|-7.1|||||TWO_SIDED|95.0|-21.6|7.3|||||SARS-CoV-2 (D614G) nAb: Part A.2 versus Part A.1|||7.3|-21.6|
72445754|NCT04927065|144407029|OTHER||GMR|1.777|||||TWO_SIDED|95.0|1.523|2.073|||||Omicron BA.1 Variant (B.1.1.529) nAb - Part F (Cohort 2): mRNA-1273.529 50 μg versus Part F (Cohort 2): mRNA-1273 50 μg|||2.073|1.523|
72445755|NCT04927065|144407030|OTHER||Percentage Difference|0.6|||||TWO_SIDED|95.0|-1.7|3.0|||||Omicron BA.1 Variant (B.1.1.529) nAb - Part F (Cohort 2): mRNA-1273.529 50 μg versus Part F (Cohort 2): mRNA-1273 50 μg|||3.0|-1.7|
72445756|NCT04927065|144407031|OTHER||Percentage Difference|17.9|||||TWO_SIDED|95.0|9.8|26.0|||||Omicron BA.1 Variant (B.1.1.529) nAb - Part F (Cohort 2): mRNA-1273.529 50 μg versus Part F (Cohort 2): mRNA-1273 50 μg|||26.0|9.8|
72560810|NCT01957150|144652094|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of 95% CI for the overall treatment difference change from Baseline between FF/VI and VI was greater than -1 % year|Percentage Change from Baseline|-0.4|||||TWO_SIDED|95.0|-1.16|0.36|||||Overall Weeks for female|||0.36|-1.16|
72560811|NCT01957150|144652095|OTHER||Percentage Change from Baseline|-1.02|||||TWO_SIDED|95.0|-1.9|-0.13|||||Overall Weeks for Male|||-0.13|-1.90|
72560812|NCT01957150|144652096|OTHER||Percentage Change from Baseline|-0.05|||||TWO_SIDED|95.0|-0.87|0.78|||||Overall Weeks for female|||0.78|-0.87|
72560813|NCT01957150|144652097|OTHER||Percentage Change from Baseline|-0.51|||||TWO_SIDED|95.0|-1.11|0.1|||||Overall week|||0.10|-1.11|
72560814|NCT01207752|144652099|SUPERIORITY_OR_OTHER_LEGACY|||||||0.55|TWO_SIDED||||||t-test, 2 sided|||||||0.550
72560815|NCT01632215|144652101|SUPERIORITY||Mean Difference (Net)|0.3|||<|0.05|TWO_SIDED||||||t-test, 1 sided|||||||<0.05
72560816|NCT04010227|144652129|SUPERIORITY||partial correlation|0.08||||0.6|TWO_SIDED|95.0|-0.23|0.4||P-value for study group x time interaction. Two-tailed p-values \<.05 were considered statistically significant.|Mixed Models Analysis|degrees of freedom = 76. multiply imputed data were used in analyses.||||0.40|-0.23|0.60
72445757|NCT04927065|144407032|OTHER||GMR|1.744|||||TWO_SIDED|97.5|1.492|2.04|||||Omicron BA.1 Variant (B.1.1.529) nAb: Part G: mRNA-1273.214 50 μg versus Part F (Cohort 2): mRNA-1273 50 μg|||2.040|1.492|
72445758|NCT04927065|144407032|OTHER||GMR|1.211|||||TWO_SIDED|97.5|1.074|1.366|||||SARS-CoV-2 (D614G) nAb: Part G: mRNA-1273.214 50 μg versus Part F (Cohort 2): mRNA-1273 50 μg|||1.366|1.074|
72445759|NCT04927065|144407033|OTHER||GMR|1.676|||||TWO_SIDED|97.5|1.396|2.013|||||Omicron BA.1 Variant (B.1.1.529) nAb: Part G: mRNA-1273.214 50 μg versus Part F (Cohort 2): mRNA-1273 50 μg|||2.013|1.396|
72445760|NCT04927065|144407033|OTHER||GMR|1.105|||||TWO_SIDED|97.5|0.97|1.26|||||SARS-CoV-2 (D614G) nAb: Part G: mRNA-1273.214 50 μg versus Part F (Cohort 2): mRNA-1273 50 μg|||1.260|0.970|
72445761|NCT04927065|144407034|OTHER||Percentage Difference|1.5|||||TWO_SIDED|97.5|-1.1|4.1|||||Omicron BA.1 Variant (B.1.1.529) nAb: Part G: mRNA-1273.214 50 μg versus Part F (Cohort 2): mRNA-1273 50 μg|||4.1|-1.1|
72445762|NCT04927065|144407035|OTHER||Percentage Difference|21.5|||||TWO_SIDED|97.5|12.8|30.2|||||Omicron BA.1 Variant (B.1.1.529) nAb: Part G: mRNA-1273.214 50 μg versus Part F (Cohort 2): mRNA-1273 50 μg|||30.2|12.8|
72445763|NCT04927065|144407036|OTHER||Percentage Difference|1.8|||||TWO_SIDED|97.5|-1.9|5.6|||||Omicron BA.1 Variant (B.1.1.529) nAb: Part G: mRNA-1273.214 50 μg versus Part F (Cohort 2): mRNA-1273 50 μg|||5.6|-1.9|
72445764|NCT04927065|144407037|OTHER||Percentage Difference|20.6|||||TWO_SIDED|97.5|12.4|28.7|||||Omicron BA.1 Variant (B.1.1.529) nAb: Part G: mRNA-1273.214 50 μg versus Part F (Cohort 2): mRNA-1273 50 μg|||28.7|12.4|
72445765|NCT04927065|144407038|OTHER||GMR|6.412|||||TWO_SIDED|95.0|5.369|7.658|||||Omicron Variant (BA.4/BA.5) nAb: Part H mRNA-1273.222 50 μg versus Part F (Cohort 2): mRNA-1273 50 μg|||7.658|5.369|
72445766|NCT04927065|144407038|OTHER||GMR|1.967|||||TWO_SIDED|95.0|1.708|2.265|||||SARS-CoV-2 (D614G) nAb: Part H mRNA-1273.222 50 μg versus Part F (Cohort 2): mRNA-1273 50 μg|||2.265|1.708|
72445767|NCT04927065|144407039|OTHER||Percentage Difference|12.2|||||TWO_SIDED|95.0|6.9|17.4|||||Omicron Variant (BA.4/BA.5) nAb: Part H mRNA-1273.222 50 μg versus Part F (Cohort 2): mRNA-1273 50 μg|||17.4|6.9|
72445768|NCT04927065|144407039|OTHER||Percentage Difference|0.0|||||TWO_SIDED|95.0|||||||SARS-CoV-2 (D614G) nAb: Part H mRNA-1273.222 50 μg versus Part F (Cohort 2): mRNA-1273 50 μg|||||
72445769|NCT04927065|144407040|OTHER||Percentage Difference|54.7|||||TWO_SIDED|95.0|47.5|61.8|||||Omicron Variant (BA.4/BA.5) nAb: Part H mRNA-1273.222 50 μg versus Part F (Cohort 2): mRNA-1273 50 μg|||61.8|47.5|
72560817|NCT04010227|144652130|SUPERIORITY||partial correlation|0.02||||0.96|TWO_SIDED|95.0|-0.29|0.34||P-value for study group x time interaction. Two-tailed p-values \<.05 were considered statistically significant.|Mixed Models Analysis|degrees of freedom = 76. Multiply imputed data were used.||||0.34|-0.29|0.96
72560818|NCT04010227|144652131|SUPERIORITY||partial correlation|0.06||||0.75|TWO_SIDED|95.0|-0.25|0.38||P-value for study group x time interaction. Two-tailed p-values \<.05 were considered statistically significant.|Mixed Models Analysis|degrees of freedom = 76. Multiply imputed data were used.||||0.38|-0.25|0.75
72619305|NCT01654250|144769242|SUPERIORITY_OR_OTHER||LS Mean Difference|18.7|STANDARD_ERROR_OF_MEAN|11.12||0.094|TWO_SIDED|95.0|-3.2|40.5|||Mixed Models Analysis|||Hour 13 post-dose (Problems attempted): Treatment comparisons for observed scores were assessed using a mixed model repeated measures analysis, with treatment (NWP09/Placebo), study center, time point and time point by treatment interaction as main effects and participant intercept as a random effect.||40.5|-3.2|0.094
72445770|NCT04927065|144407040|OTHER||Percentage Difference|37.6|||||TWO_SIDED|95.0|29.3|45.9|||||SARS-CoV-2 (D614G) nAb: Part H mRNA-1273.222 50 μg versus Part F (Cohort 2): mRNA-1273 50 μg|||45.9|29.3|
72445771|NCT04927065|144407049|OTHER||GMR|0.836|||||TWO_SIDED|95.0|0.745|0.938|||||SARS-CoV-2 (D614G) nAb: Part F (Cohort 2): mRNA-1273.529 50 μg versus Part F (Cohort 2): mRNA-1273 50 μg|||0.938|0.745|
72445772|NCT04927065|144407050|OTHER||SRR Difference|0.0|||||TWO_SIDED|95.0|||||||SARS-CoV-2 (D614G) nAb: Part F (Cohort 2): mRNA-1273.529 50 μg versus Part F (Cohort 2): mRNA-1273 50 μg 95% CI could not be calculated due to the SRR difference is 0.|||||
72445773|NCT04927065|144407051|OTHER||SRR Difference|-13.1|||||TWO_SIDED|95.0|-21.2|-5.0|||||SARS-CoV-2 (D614G) nAb: Part F (Cohort 2): mRNA-1273.529 50 μg versus Part F (Cohort 2): mRNA-1273 50 μg|||-5.0|-21.2|
72445774|NCT04927065|144407052|OTHER||SRR Difference|0.0|||||TWO_SIDED|97.5|||||||SARS-CoV-2 (D614G) nAb at Day 29: Part G versus Part F (Cohort 2) mRNA-1273 95% CI could not be calculated due to the SRR difference is 0.|||||
72445775|NCT04927065|144407052|OTHER||SRR Difference|0.9|||||TWO_SIDED|97.5|-1.6|3.5|||||SARS-CoV-2 (D614G) nAb at Day 91: Part G versus Part F (Cohort 2) mRNA-1273|||3.5|-1.6|
72445776|NCT04927065|144407052|OTHER||SRR Difference|-0.1|||||TWO_SIDED|95.0|-2.3|2.1|||||SARS-CoV-2 (D614G) nAb at Day 181: Part G versus Part F (Cohort 2) mRNA-1273|||2.1|-2.3|
72445777|NCT04927065|144407052|OTHER||SRR Difference|-1.9|||||TWO_SIDED|95.0|-5.3|1.5|||||SARS-CoV-2 (D614G) nAb at Day 366: Part G versus Part F (Cohort 2) mRNA-1273|||1.5|-5.3|
72445778|NCT04927065|144407053|OTHER||SRR Difference|10.9|||||TWO_SIDED|97.5|1.7|20.1|||||SARS-CoV-2 (D614G) nAb at Day 29: Part G versus Part F (Cohort 2) mRNA-1273|||20.1|1.7|
72445779|NCT04927065|144407053|OTHER||SRR Difference|9.2|||||TWO_SIDED|97.5|1.4|17.0|||||SARS-CoV-2 (D614G) nAb at Day 91: Part G versus Part F (Cohort 2) mRNA-1273|||17.0|1.4|
72445780|NCT04927065|144407053|OTHER||SRR Difference|10.1|||||TWO_SIDED|95.0|3.0|17.2|||||SARS-CoV-2 (D614G) nAb at Day 181: Part G versus Part F (Cohort 2) mRNA-1273|||17.2|3.0|
72445781|NCT04927065|144407053|OTHER||SRR Difference|4.3|||||TWO_SIDED|95.0|-5.0|13.6|||||SARS-CoV-2 (D614G) nAb at Day 366: Part G versus Part F (Cohort 2) mRNA-1273|||13.6|-5.0|
72445782|NCT04927065|144407055|OTHER||GMR|1.818|||||TWO_SIDED|95.0|1.469|2.249|||||SARS-CoV-2 (D614G) nAb: Part H versus Part F (Cohort 2) mRNA-1273|||2.249|1.469|
72560819|NCT04010227|144652132|SUPERIORITY||partial correlation|0.09||||0.33|TWO_SIDED|95.0|-0.23|0.4||P-value for study group x time interaction. Two-tailed p-values \<.05 were considered statistically significant.|Mixed Models Analysis|degrees of freedom = 144. Multiply imputed data were used.||||0.40|-0.23|0.33
72619306|NCT01654250|144769242|SUPERIORITY_OR_OTHER||LS Mean Difference|22.6|STANDARD_ERROR_OF_MEAN|11.44||0.049|TWO_SIDED|95.0|0.1|45.1|||Mixed Models Analysis|||Hour 0.75 post-dose (Problems correct): Treatment comparisons for observed scores were assessed using a mixed model repeated measures analysis, with treatment (NWP09/Placebo), study center, time point and time point by treatment interaction as main effects and participant intercept as a random effect.||45.1|0.1|0.049
72445783|NCT04927065|144407057|OTHER||SRR Difference|0.0|||||TWO_SIDED|95.0|-2.6|2.5|||||SARS-CoV-2 (D614G) nAb: Part H versus Part F (Cohort 2) mRNA-1273|||2.5|-2.6|
72445784|NCT04927065|144407059|OTHER||SRR Difference|25.5|||||TWO_SIDED|95.0|16.9|34.1|||||SARS-CoV-2 (D614G) nAb: Part H versus Part F (Cohort 2) mRNA-1273|||34.1|16.9|
72445785|NCT04927065|144407060|OTHER||SRR Difference|5.0|||||TWO_SIDED|95.0|0.3|9.8|||||Omicron BA.1 Variant (B.1.1.529) nAb at Day 181: Part G versus Part F (Cohort 2) mRNA-1273|||9.8|0.3|
72445786|NCT04927065|144407060|OTHER||SRR Difference|5.6|||||TWO_SIDED|95.0|-0.3|11.5|||||Omicron BA.1 Variant (B.1.1.529) nAb at Day 366: Part G versus Part F (Cohort 2) mRNA-1273|||11.5|-0.3|
72445787|NCT04927065|144407061|OTHER||SRR Difference|14.5|||||TWO_SIDED|95.0|6.7|22.3|||||Omicron BA.1 Variant (B.1.1.529) nAb at Day 181: Part G versus Part F (Cohort 2) mRNA-1273|||22.3|6.7|
72445788|NCT04927065|144407061|OTHER||SRR Difference|8.0|||||TWO_SIDED|95.0|-2.1|18.0|||||Omicron BA.1 Variant (B.1.1.529) nAb at Day 366: Part G versus Part F (Cohort 2) mRNA-1273|||18.0|-2.1|
72445789|NCT04927065|144407062|OTHER||GMR|1.637|||||TWO_SIDED|95.0|1.243|2.155|||||SARS-CoV-2 (B.1.1.529) nAb at Day 181: Part G versus Part F (Cohort 2) mRNA-1273|||2.155|1.243|
72445790|NCT04927065|144407062|OTHER||GMR|1.373|||||TWO_SIDED|95.0|0.953|1.976|||||SARS-CoV-2 (B.1.1.529) nAb at Day 366: Part G versus Part F (Cohort 2) mRNA-1273|||1.976|0.953|
72445791|NCT04927065|144407062|OTHER||GMR|1.271|||||TWO_SIDED|95.0|1.051|1.537|||||SARS-CoV-2 (D614G) nAb at Day 181: Part G versus Part F (Cohort 2) mRNA-1273|||1.537|1.051|
72445792|NCT04927065|144407062|OTHER||GMR|1.101|||||TWO_SIDED|95.0|0.83|1.461|||||SARS-CoV-2 (D614G) nAb at Day 366: Part G versus Part F (Cohort 2) mRNA-1273|||1.461|0.830|
72497644|NCT01512264|144525184|OTHER|||||||0.109|||||||t-test, 2 sided|||paired t- test between time point 1 and time point 4 for the rTMS group and COWAT test were calculated. Cohen's d was calculated to determine the power of the test. The Cohen's d calculated for this test = -0.71.||||0.109
72445793|NCT05521308|144407143|SUPERIORITY||Mean Difference (Final Values)|0.38|||<|0.001|TWO_SIDED|95.0|0.2|1.0|||ANOVA|||This is to see if there is a difference in preference count per participant between Variation #1, Variation #2 and Same counts.||1.00|0.20|<0.001
72445794|NCT05521308|144407143|SUPERIORITY||Mean Difference (Final Values)|3.23||||0.02|TWO_SIDED|95.0|0.41|6.05|||t-test, 2 sided|||This is to see if there is a difference between Variation #1 and Variation #2 preference counts per participant.||6.05|0.41|0.02
72445795|NCT05521308|144407143|SUPERIORITY||Mean Difference (Final Values)|0.35|||<|0.001|TWO_SIDED|95.0|0.18|1.0|||ANOVA|||This is to see if there is a difference in preference count per participant between Variation #1, Variation #3 and Same counts.||1.00|0.18|<0.001
72445796|NCT05521308|144407143|SUPERIORITY||Mean Difference (Final Values)|1.09||||0.54|TWO_SIDED|95.0|-1.36|3.55|||t-test, 2 sided|||This is to see if there is a difference between Variation #1 and Variation #3 preference counts per participant.||3.55|-1.36|.54
72445797|NCT05521308|144407143|SUPERIORITY||Mean Difference (Final Values)|0.05||||0.231|TWO_SIDED|95.0|0.0|1.0|||ANOVA|||This is to see if there is a difference in preference count per participant between Variation #2, Variation #3, and Same counts.||1.00|0|.231
72445798|NCT05521308|144407145|SUPERIORITY||Cramer's V|0.14||||0.13|TWO_SIDED||||||Chi-squared|This is to see if there is a difference in preference counts between standard curve, variation #4, and # of times they were rated as the same. -Indoor||||||.13
72445799|NCT05521308|144407145|SUPERIORITY||Cramer's V|0.2||||0.04|TWO_SIDED|||||This is to see if there is a difference in preference counts between standard curve, variation #4, and # of time they were rated as the same. -Outdoor|Chi-squared|||||||0.04
72445800|NCT05521308|144407145|SUPERIORITY||Cramer's V|0.2||||0.04|TWO_SIDED||||||Chi-squared|||The number of participants that showed overall preference toward variation #4 vs. the standard curve vs. no preference. - Outdoors.||||0.04
72445801|NCT05521308|144407146|SUPERIORITY||Effect Size|0.26|||<|0.001|TWO_SIDED|95.0|0.1|1.0|||ANOVA|Initally this is to see if there is a differnce between Unaided, Aided #1 and Aided #2.||Standard Curve vs Variation #4||1.00|0.10|<0.001
72445802|NCT05521308|144407146|SUPERIORITY||Mean Difference (Final Values)|-0.24||||0.855|TWO_SIDED|95.0|-2.83|2.35||Post-Hoc Pairwise Comparison|t-test, 2 sided|Standard Curve vs Variation #4||||2.35|-2.83|0.855
72445803|NCT03675282|144407174|SUPERIORITY||Mean Difference (Final Values)|19.8||||0.66|TWO_SIDED||||||paired t-test|||Parkinson Disease - Stage 1 (Baseline vs. 24 months)||||0.66
72445804|NCT03675282|144407174|SUPERIORITY||Mean Difference (Final Values)|-21.3||||0.63|TWO_SIDED||||||paired t-test|||Parkinson Disease - Stage 2 (Baseline vs. 24 months)||||0.63
72445805|NCT03675282|144407174|SUPERIORITY||Mean Difference (Final Values)|0.87||||0.99|TWO_SIDED||||||paired t-test|||REM Sleep Behavior Disorder (Baseline vs. 24 months)||||0.99
72445806|NCT03675282|144407174|SUPERIORITY||Mean Difference (Final Values)|11.5||||0.67|TWO_SIDED||||||paired t-test|||Healthy Controls (Baseline vs. 24 months)||||0.67
72445807|NCT03675282|144407175|SUPERIORITY||Mean Difference (Final Values)|-0.625||||0.4|TWO_SIDED||||||paired t-test|||Parkinson Disease - Stage 1 UPDRS Part I (Baseline vs. 24 months)||||0.40
72445808|NCT03675282|144407175|SUPERIORITY||Mean Difference (Final Values)|-1.453||||0.4|TWO_SIDED||||||paired t-test|||Parkinson Disease - Stage 1 UPDRS Part II (Baseline vs. 24 months)||||0.40
72445809|NCT03675282|144407175|SUPERIORITY||Mean Difference (Final Values)|-6.15||||0.04|TWO_SIDED|||||Parkinson Disease - Stage 1 UPDRS Part III (Baseline vs. 24 months)|paired t-test|||||||0.04
72445810|NCT03675282|144407175|SUPERIORITY||Mean Difference (Final Values)|-0.056||||0.94|TWO_SIDED||||||paired t-test|||Parkinson Disease - Stage 1 UPDRS Part IV (Baseline vs. 24 months)||||0.94
72445811|NCT03675282|144407175|SUPERIORITY||Mean Difference (Final Values)|-0.414||||0.53|TWO_SIDED||||||paired t-test|||Parkinson Disease - Stage 2 UPDRS Part I (Baseline vs. 24 months)||||0.53
72445812|NCT03675282|144407175|SUPERIORITY||Mean Difference (Final Values)|-1.779||||0.38|TWO_SIDED||||||paired t-test|||Parkinson Disease - Stage 2 UPDRS Part II (Baseline vs. 24 months)||||0.38
72445813|NCT03675282|144407175|SUPERIORITY||Mean Difference (Final Values)|-3.59||||0.24|TWO_SIDED||||||paired t-test|||Parkinson Disease - Stage 2 UPDRS Part III (Baseline vs. 24 months)||||0.24
72445814|NCT03675282|144407175|SUPERIORITY||Mean Difference (Final Values)|-0.376||||0.73|TWO_SIDED||||||paired t-test|||Parkinson Disease - Stage 2 UPDRS Part IV (Baseline vs. 24 months)||||0.73
72445815|NCT03675282|144407175|SUPERIORITY||Mean Difference (Final Values)|-1.187||||0.16|TWO_SIDED||||||paired t-test|||REM Sleep Behavior Disorder UPDRS Part I (Baseline vs. 24 months)||||0.16
72619307|NCT01654250|144769242|SUPERIORITY_OR_OTHER||LS Mean Difference|34.4|STANDARD_ERROR_OF_MEAN|11.44||0.003|TWO_SIDED|95.0|11.9|56.9|||Mixed Models Analysis|||Hour 2 post-dose (Problems correct): Treatment comparisons for observed scores were assessed using a mixed model repeated measures analysis, with treatment (NWP09/Placebo), study center, time point and time point by treatment interaction as main effects and participant intercept as a random effect.||56.9|11.9|0.003
72619308|NCT01654250|144769242|SUPERIORITY_OR_OTHER||LS Mean Difference|32.9|STANDARD_ERROR_OF_MEAN|11.44||0.004|TWO_SIDED|95.0|10.5|55.4|||Mixed Models Analysis|||Hour 4 post-dose (Problems correct): Treatment comparisons for observed scores were assessed using a mixed model repeated measures analysis, with treatment (NWP09/Placebo), study center, time point and time point by treatment interaction as main effects and participant intercept as a random effect.||55.4|10.5|0.004
72445816|NCT03675282|144407175|SUPERIORITY||Mean Difference (Final Values)|-0.154||||0.75|TWO_SIDED||||||paired t-test|||REM Sleep Behavior Disorder UPDRS Part II (Baseline vs. 24 months)||||0.75
72445817|NCT03675282|144407175|SUPERIORITY||Mean Difference (Final Values)|-0.829||||0.28|TWO_SIDED||||||paired t-test|||REM Sleep Behavior Disorder UPDRS Part III (Baseline vs. 24 months)||||0.28
72445818|NCT03675282|144407175|SUPERIORITY||Mean Difference (Final Values)|-0.077||||0.85|TWO_SIDED||||||paired t-test|||REM Sleep Behavior Disorder UPDRS Part IV (Baseline vs. 24 months)||||0.85
72445819|NCT03675282|144407175|SUPERIORITY||Mean Difference (Final Values)|0.204||||0.78|TWO_SIDED||||||paired t-test|||Healthy Controls UPDRS Part I (Baseline vs. 24 months)||||0.78
72445820|NCT03675282|144407175|SUPERIORITY||Mean Difference (Final Values)|-0.381||||0.03|TWO_SIDED||||||paired t-test|||Healthy Controls UPDRS Part IV (Baseline vs. 24 months)||||0.03
72445821|NCT03675282|144407176|SUPERIORITY||Mean Difference (Final Values)|0.4||||0.3|TWO_SIDED||||||paired t-test|||Parkinson Disease - Stage 1 (Baseline vs. 24 months)||||0.30
72560820|NCT04010227|144652133|SUPERIORITY||partial correlation|0.03||||0.91|TWO_SIDED|95.0|-0.29|0.34||P-value for study group x time interaction. Two-tailed p-values \<.05 were considered statistically significant.|Mixed Models Analysis|degrees of freedom = 144. Multiply imputed data were used.||||0.34|-0.29|0.91
72560821|NCT04010227|144652134|SUPERIORITY||partial correlation|0.06||||0.74|TWO_SIDED|95.0|-0.25|0.38||P-value for study group x time interaction for patient physical quality of life. Two-tailed p-values \<.05 were considered statistically significant.|Mixed Models Analysis|degrees of freedom = 76. Multiply imputed data were used.||||0.38|-0.25|0.74
72445822|NCT03675282|144407176|SUPERIORITY||Mean Difference (Final Values)|0.03||||0.94|TWO_SIDED||||||paired t-test|||Parkinson Disease - Stage 2 (Baseline vs. 24 months)||||0.94
72619309|NCT01654250|144769242|SUPERIORITY_OR_OTHER||LS Mean Difference|27.0|STANDARD_ERROR_OF_MEAN|11.44||0.019|TWO_SIDED|95.0|4.5|49.5|||Mixed Models Analysis|||Hour 8 post-dose (Problems correct): Treatment comparisons for observed scores were assessed using a mixed model repeated measures analysis, with treatment (NWP09/Placebo), study center, time point and time point by treatment interaction as main effects and participant intercept as a random effect.||49.5|4.5|0.019
72445823|NCT03675282|144407176|SUPERIORITY||Mean Difference (Final Values)|0.5||||0.45|TWO_SIDED||||||paired t-test|||REM Sleep Behavior Disorder (Baseline vs. 24 months)||||0.45
72445824|NCT03675282|144407176|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.8|TWO_SIDED||||||paired t-test|||Healthy Controls (Baseline vs. 24 months)||||0.80
72445825|NCT05875142|144407181|NON_INFERIORITY|test of non-inferiority is H0: control\>=treatment vs HA: control\<treatment||||||0.0008|||||||t-test, 1 sided|||T compared with TM||||0.0008
72445826|NCT05875142|144407181|NON_INFERIORITY|test of non-inferiority is H0: control\>=treatment vs HA: control\<treatment||||||5.03e-06|||||||t-test, 1 sided|||T compared with TMC.||||0.00000503
72445827|NCT05875142|144407182|NON_INFERIORITY|test of non-inferiority is H0: control\>=treatment vs HA: control\<treatment||||||0.0176|||||||t-test, 1 sided|||T compared with T||||0.0176
72445828|NCT05875142|144407182|NON_INFERIORITY|test of non-inferiority is H0: control\>=treatment vs HA: control\<treatment||||||0.0056|||||||t-test, 1 sided|||Comparing T with TMC.||||0.0056
72619310|NCT01654250|144769242|SUPERIORITY_OR_OTHER||LS Mean difference|8.6|STANDARD_ERROR_OF_MEAN|11.44||0.451|TWO_SIDED|95.0|-13.9|31.1|||Mixed Models Analysis|||Hour 10 (Problems correct): Treatment comparisons for observed scores were assessed using a mixed model repeated measures analysis, with treatment (NWP09/Placebo), study center, time point and time point by treatment interaction as main effects and participant intercept as a random effect.||31.1|-13.9|0.451
72445829|NCT05875142|144407183|NON_INFERIORITY|test of non-inferiority is H0: control\<=treatment vs HA: control\>treatment||||||0.4066|||||||t-test, 1 sided|||T compared with TM||||0.4066
72445830|NCT05875142|144407183|NON_INFERIORITY|test of non-inferiority is H0: control\<=treatment vs HA: control\>treatment||||||0.4045|||||||t-test, 1 sided|||T compared with TMC||||0.4045
72445831|NCT03210272|144407197|OTHER||Geometric Mean Ratio T/R (%)|155.6|||||TWO_SIDED|90.0|130.66|185.3|||||intra-individual gCV (%) = 18.1|The statistical model to assess relative bioavailability in the FE part was an analysis of variance (ANOVA) on the ln-transformed parameters AUC and Cmax including effects for 'sequence', 'subjects nested within sequences', 'period', and 'treatment'||185.30|130.66|
72445832|NCT03210272|144407197|OTHER||Ratio T/R (%)|240.12|||||TWO_SIDED|90.0|196.25|293.81|||||intra-individual gCV (%) = 27.8|The statistical model to assess relative bioavailability in the FE part was an analysis of variance (ANOVA) on the ln-transformed parameters AUC and Cmax including effects for 'sequence', 'subjects nested within sequences', 'period', and 'treatment'||293.81|196.25|
72445833|NCT03210272|144407198|OTHER||Geometric Mean Ratio T/R (%)|156.37|||||TWO_SIDED|90.0|132.73|184.22|||||intra-individual gCV (%) = 17.0|The statistical model to assess relative bioavailability in the FE part was an analysis of variance (ANOVA) on the ln-transformed parameters AUC and Cmax including effects for 'sequence', 'subjects nested within sequences', 'period', and 'treatment'||184.22|132.73|
72445834|NCT03210272|144407198|OTHER||Ratio T/R (%)|245.56|||||TWO_SIDED|90.0|200.7|300.44|||||intra-individual gCV (%) = 27.8|The statistical model to assess relative bioavailability in the FE part was an analysis of variance (ANOVA) on the ln-transformed parameters AUC and Cmax including effects for 'sequence', 'subjects nested within sequences', 'period', and 'treatment'||300.44|200.70|
72560822|NCT04010227|144652134|SUPERIORITY||partial correlation|0.14||||0.24|TWO_SIDED|95.0|-0.18|0.45||P-value for study group x time interaction for patient psychological quality of life. Two-tailed p-values \<.05 were considered statistically significant.|Mixed Models Analysis|degrees of freedom = 76. Multiply imputed data were used.||||0.45|-0.18|0.24
72445835|NCT03210272|144407199|OTHER||Geometric Mean Ratio T/R (%)|158.74|||||TWO_SIDED|90.0|114.25|220.56|||||intra-individual gCV (%) = 34.8|The statistical model to assess relative bioavailability in the FE part was an analysis of variance (ANOVA) on the ln-transformed parameters AUC and Cmax including effects for 'sequence', 'subjects nested within sequences', 'period', and 'treatment'||220.56|114.25|
72445836|NCT03210272|144407199|OTHER||Ratio T/R (%)|246.13|||||TWO_SIDED|90.0|203.37|297.89|||||intra-individual gCV (%) = 26.2|The statistical model to assess relative bioavailability in the FE part was an analysis of variance (ANOVA) on the ln-transformed parameters AUC and Cmax including effects for 'sequence', 'subjects nested within sequences', 'period', and 'treatment'||297.89|203.37|
72445837|NCT03039023|144407200|EQUIVALENCE|For equivalence testing, the difference was assumed to be 0.||||||0.2||||||A p-value \<0.05 was considered significant.|Wilcoxon signed-rank test|||||||0.20
72445838|NCT03039023|144407200|EQUIVALENCE|For equivalence testing, the difference was assumed to be 0.|||||<|0.0001||||||A p-value \<0.05 was considered significant.|Wilcoxon Signed Rank test|||||||<0.0001
72445839|NCT03039023|144407200|EQUIVALENCE|For equivalence testing, the difference was assumed to be 0.|||||<|0.0001||||||A p-value \<0.05 was considered significant.|Wilcoxon Signed Rank test|||||||<0.0001
72445840|NCT03039023|144407200|EQUIVALENCE|For equivalence testing, the difference was assumed to be 0.|||||<|0.0001||||||A p-value \<0.05 was considered significant.|Wilcoxon Signed Rank test|||||||<0.0001
72560823|NCT04010227|144652134|SUPERIORITY||partial correlation|0.06||||0.78|TWO_SIDED|95.0|-0.26|0.37||P-value for study group x time interaction for patient existential quality of life. Two-tailed p-values \<.05 were considered statistically significant.|Mixed Models Analysis|degrees of freedom = 76. Multiply imputed data were used.||||0.37|-0.26|0.78
72560824|NCT04010227|144652134|SUPERIORITY||partial correlation|0.13||||0.29|TWO_SIDED|95.0|-0.19|0.44||P-value for study group x time interaction for patient social quality of life. Two-tailed p-values \<.05 were considered statistically significant.|Mixed Models Analysis|degrees of freedom = 76. Multiply imputed data were used.||||0.44|-0.19|0.29
72560825|NCT04010227|144652135|SUPERIORITY||partial correlation|0.03||||0.92|TWO_SIDED|95.0|-0.28|0.35||P-value for study group x time interaction for caregiver physical quality of life. Two-tailed p-values \<.05 were considered statistically significant.|Mixed Models Analysis|degrees of freedom = 76. Multiply imputed data were used.||||0.35|-0.28|0.92
72560826|NCT04010227|144652135|SUPERIORITY||partial correlation|0.06||||0.79|TWO_SIDED|95.0|-0.26|0.37||P-value for study group x time interaction for caregiver psychological quality of life. Two-tailed p-values \<.05 were considered statistically significant.|Mixed Models Analysis|degrees of freedom = 76. Multiply imputed data were used.||||0.37|-0.26|0.79
72560827|NCT04010227|144652136|SUPERIORITY||partial correlation|0.02||||0.94|TWO_SIDED|95.0|-0.3|0.34||P-value for study group x time interaction. Two-tailed p-values \<.05 were considered statistically significant.|Mixed Models Analysis|degrees of freedom = 144. Multiply imputed data were used.||||0.34|-0.30|0.94
72560828|NCT01841073|144652137|SUPERIORITY|||||||0.005||||||p-value was calculated, and is not attempting to indicate the threshold for statistical significance|ANCOVA|||||||0.005
72560829|NCT01841073|144652138|SUPERIORITY|||||||0.027|||||||ANCOVA|||||||0.027
72560830|NCT01841073|144652139|SUPERIORITY|||||||0.13|||||||ANCOVA|||||||0.13
72560831|NCT00550147|144652147|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.125|STANDARD_ERROR_OF_MEAN|0.1933|<|0.05|TWO_SIDED|95.0|-1.52|-0.72|||t-test, 2 sided|Paired t-test (comparing augmentation period start score with end score), 23 df. Value is Visit 10 score minus Visit 5 score (null hypothesis=0).|This was a comparison of pre-post change in a single group, with treatment administered open-label.|This was a repeated-measures analysis, using a single group of subjects who were administered quetiapine in addition to OROS mph. See Kronenberger et al. (2007, Journal of Child and Adolescent Psychopharmacology) for additional information.||-0.72|-1.52|<0.05
72445841|NCT03039023|144407200|EQUIVALENCE|For equivalence testing, the difference was assumed to be 0.||||||0.27||||||A p-value \<0.05 was considered significant.|Wilcoxon Signed Rank test|||||||0.27
72445842|NCT03039023|144407201|EQUIVALENCE|For equivalence testing, the difference was assumed to be 0.||||||0.1||||||A p-value \<0.05 was considered significant.|Wilcoxon Signed Rank test|||||||0.10
72445843|NCT03039023|144407201|EQUIVALENCE|For equivalence testing, the difference was assumed to be 0.||||||0.0002||||||A p-value \<0.05 was considered significant.|Wilcoxon Signed Rank test|||||||0.0002
72445844|NCT03039023|144407201|EQUIVALENCE|For equivalence testing, the difference was assumed to be 0.||||||0.01||||||A p-value \<0.05 was considered significant.|Wilcoxon Signed Rank test|||||||0.01
72560832|NCT00550147|144652148|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.33|STANDARD_ERROR_OF_MEAN|0.2056|<|0.05||95.0|-1.75|-0.91|||t-test, 2 sided|Paired t-test (comparing augmentation period start score with end score), 23 df. Value is Visit 10 score minus Visit 5 score (null hypothesis=0).|This was a comparison of pre-post change in a single group, with treatment administered open-label.|This was a repeated-measures analysis, using a single group of subjects who were administered quetiapine in addition to OROS mph. Results reported here are for the augmentation period (Visit 5-10). See Kronenberger et al. (2007, Journal of Child and Adolescent Psychopharmacology) for additional information.||-0.91|-1.75|<0.05
72445845|NCT03039023|144407201|EQUIVALENCE|For equivalence testing, the difference was assumed to be 0.||||||0.006||||||A p-value \<0.05 was considered significant.|Wilcoxon Signed Rank test|||||||0.006
72445846|NCT03039023|144407201|EQUIVALENCE|For equivalence testing, the difference was assumed to be 0.||||||0.79||||||A p-value \<0.05 was considered significant.|Wilcoxon Signed Rank test|||||||0.79
72445847|NCT03039023|144407202|EQUIVALENCE|For equivalence testing, the difference was assumed to be 0.||||||0.28||||||A p-value \<0.05 was considered significant.|Wilcoxon Signed Rank test|||||||0.28
72445848|NCT03039023|144407202|EQUIVALENCE|For equivalence testing, the difference was assumed to be 0.|||||<|0.0001||||||A p-value \<0.05 was considered significant.|Wilcoxon Signed Rank test|||||||<0.0001
72445849|NCT03039023|144407202|EQUIVALENCE|For equivalence testing, the difference was assumed to be 0.|||||<|0.0001||||||A p-value \<0.05 was considered significant.|Wilcoxon Signed Rank test|||||||<0.0001
72445850|NCT03039023|144407202|EQUIVALENCE|For equivalence testing, the difference was assumed to be 0.|||||<|0.0001||||||A p-value \<0.05 was considered significant.|Wilcoxon Signed Rank test|||||||<0.0001
72445851|NCT03039023|144407202|EQUIVALENCE|For equivalence testing, the difference was assumed to be 0.||||||0.11||||||A p-value \<0.05 was considered significant.|Wilcoxon Signed Rank test|||||||0.11
72445852|NCT03039023|144407203|EQUIVALENCE|For equivalence testing, the difference was assumed to be 0.||||||0.005||||||A p-value \<0.05 was considered significant.|Wilcoxon Signed Rank test|||||||0.005
72445853|NCT03039023|144407203|EQUIVALENCE|For equivalence testing, the difference was assumed to be 0.|||||<|0.001||||||A p-value \<0.05 was considered significant.|Wilcoxon Signed Rank test|||||||<0.001
72445854|NCT03039023|144407203|EQUIVALENCE|For equivalence testing, the difference was assumed to be 0.|||||<|0.001||||||A p-value \<0.05 was considered significant.|Wilcoxon Signed Rank test|||||||<0.001
72445855|NCT03039023|144407203|EQUIVALENCE|For equivalence testing, the difference was assumed to be 0.||||||0.009||||||A p-value \<0.05 was considered significant.|Wilcoxon Signed Rank test|||||||0.009
72445856|NCT03039023|144407203|EQUIVALENCE|For equivalence testing, the difference was assumed to be 0.||||||0.04||||||A p-value \<0.05 was considered significant.|Wilcoxon Signed Rank test|||||||0.04
72560833|NCT00550147|144652149|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-47.3|STANDARD_ERROR_OF_MEAN|13.06|<|0.05||95.0|-74.3|-20.2|||t-test, 2 sided|Paired t-test (comparing augmentation period start score with end score), 23 df. Value is Visit 10 score minus Visit 5 score (null hypothesis=0).|This was a comparison of pre-post change in a single group, with treatment administered open-label.|This was a repeated-measures analysis, using a single group of subjects who were administered quetiapine in addition to OROS mph. Results reported here are for the augmentation period (Visit 5-10). See Kronenberger et al. (2007, Journal of Child and Adolescent Psychopharmacology) for additional information.||-20.2|-74.3|<0.05
72560834|NCT00550147|144652150|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.17|STANDARD_ERROR_OF_MEAN|1.39|<|0.05|TWO_SIDED|95.0|-7.04|-1.29|||t-test, 2 sided|Paired t-test (comparing augmentation period start score with end score), 23 df. Value is Visit 10 score minus Visit 5 score (null hypothesis=0).|This was a comparison of pre-post change in a single group, with treatment administered open-label.|This was a repeated-measures analysis, using a single group of subjects who were administered quetiapine in addition to OROS mph. Results reported here are for the augmentation period (Visit 5-10). See Kronenberger et al. (2007, Journal of Child and Adolescent Psychopharmacology) for additional information.||-1.29|-7.04|<0.05
72560835|NCT00550147|144652151|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.29|STANDARD_ERROR_OF_MEAN|2.16|<|0.05||95.0|-17.76|-8.82|||t-test, 2 sided|Paired t-test (comparing augmentation period start score with end score), 23 df. Value is Visit 10 score minus Visit 5 score (null hypothesis=0).|This was a comparison of pre-post change in a single group, with treatment administered open-label.|This was a repeated-measures analysis, using a single group of subjects who were administered quetiapine in addition to OROS mph. Results reported here are for the augmentation period (Visit 5-10). See Kronenberger et al. (2007, Journal of Child and Adolescent Psychopharmacology) for additional information.||-8.82|-17.76|<0.05
72619311|NCT01654250|144769242|SUPERIORITY_OR_OTHER||LS Mean Difference|9.8|STANDARD_ERROR_OF_MEAN|11.44||0.394|TWO_SIDED|95.0|-12.7|32.2|||Mixed Models Analysis|||Hour 12 post-dose (Problems correct): Treatment comparisons for observed scores were assessed using a mixed model repeated measures analysis, with treatment (NWP09/Placebo), study center, time point and time point by treatment interaction as main effects and participant intercept as a random effect.||32.2|-12.7|0.394
72445857|NCT03039023|144407204|EQUIVALENCE|For equivalence testing, the difference was assumed to be 0.||||||0.93||||||A p-value \<0.05 was considered significant.|Wilcoxon Signed Rank test|||||||0.93
72445858|NCT03039023|144407204|EQUIVALENCE|For equivalence testing, the difference was assumed to be 0.||||||0.01||||||A p-value \<0.05 was considered significant.|Wilcoxon Signed Rank test|||||||0.01
72445859|NCT03039023|144407204|EQUIVALENCE|For equivalence testing, the difference was assumed to be 0.||||||0.003||||||A p-value \<0.05 was considered significant.|Wilcoxon Signed Rank test|||||||0.003
72445860|NCT03039023|144407204|EQUIVALENCE|For equivalence testing, the difference was assumed to be 0.||||||0.04||||||A p-value \<0.05 was considered significant.|Wilcoxon Signed Rank test|||||||0.04
72445861|NCT03039023|144407204|EQUIVALENCE|For equivalence testing, the difference was assumed to be 0.||||||0.99||||||A p-value \<0.05 was considered significant.|Wilcoxon Signed Rank test|||||||0.99
72445862|NCT03039023|144407205|EQUIVALENCE|For equivalence testing, the difference was assumed to be 0.||||||0.02||||||A p-value \<0.05 was considered significant.|Wilcoxon Signed Rank test|||||||0.02
72445863|NCT03039023|144407205|EQUIVALENCE|For equivalence testing, the difference was assumed to be 0.|||||<|0.0001||||||A p-value \<0.05 was considered significant.|Wilcoxon Signed Rank test|||||||<0.0001
72445864|NCT03039023|144407205|EQUIVALENCE|For equivalence testing, the difference was assumed to be 0.|||||<|0.0001||||||A p-value \<0.05 was considered significant.|Wilcoxon Signed Rank test|||||||<0.0001
72445865|NCT03039023|144407205|EQUIVALENCE|For equivalence testing, the difference was assumed to be 0.||||||0.001||||||A p-value \<0.05 was considered significant.|Wilcoxon Signed Rank test|||||||0.001
72445866|NCT03039023|144407205|EQUIVALENCE|For equivalence testing, the difference was assumed to be 0.||||||0.02||||||A p-value \<0.05 was considered significant.|Wilcoxon Signed Rank test|||||||0.02
72445867|NCT05260684|144407217|OTHER||Hazard Ratio (HR)|1.32||||0.02|TWO_SIDED|95.0|1.05|1.65|||Wald Chi- Square Statistic||HR was estimated using multivariable Cox proportional hazard models.|Statistical analysis data is presented for Dabrafenib+Trametinib relative to Encorafenib+Binimetinib (reference).||1.65|1.05|0.02
72445868|NCT05260684|144407217|OTHER||Hazard Ratio (HR)|1.17||||0.47|TWO_SIDED|95.0|0.76|1.79|||Wald Chi- Square Statistic||HR was estimated using multivariable Cox proportional hazard models.|Statistical analysis data is presented for Vemurafenib + Cobimetinib relative to Encorafenib+Binimetinib (reference).||1.79|0.76|0.47
72445869|NCT05260684|144407218|OTHER||Hazard Ratio (HR)|1.49|||<|0.001|TWO_SIDED|95.0|1.2|1.87|||Wald Chi- Square Statistic||HR was estimated using multivariable Cox proportional hazard models.|Statistical analysis data is presented for Dabrafenib+Trametinib relative to Encorafenib+Binimetinib (reference).||1.87|1.20|<0.001
72445870|NCT05260684|144407218|OTHER||Hazard Ratio (HR)|1.2||||0.4|TWO_SIDED|95.0|0.79|1.82|||Wald Chi- Square Statistic||HR was estimated using multivariable Cox proportional hazard models.|Statistical analysis data is presented for Vemurafenib + Cobimetinib relative to Encorafenib+Binimetinib (reference).||1.82|0.79|0.40
72445871|NCT03519581|144407235|OTHER|The primary statistical analysis was an intention-to-treat analysis. The primary outcome was analyzed by Kruskal-Wallis test because the data was non-parametric.||||||0.76|||||||Kruskal-Wallis|||The target sample size for the study was 30 eyes, based on power calculations to achieve 80% power assuming 40% of sham-treated eyes will reach the vision loss threshold within 2 years, while SML treatment will reduce that value to 15%, using a 2:1 ratio for randomization (2 treatment : 1 sham).||||.76
72445872|NCT03519581|144407236|SUPERIORITY|||||||0.16|||||||t-test, 2 sided|||||||.16
72445873|NCT03519581|144407237|SUPERIORITY|||||||0.12|||||||t-test, 2 sided|||||||.12
72445874|NCT03519581|144407238|SUPERIORITY|||||||0.68|||||||t-test, 2 sided|||||||.68
72445875|NCT03519581|144407239|SUPERIORITY|||||||0.96|||||||t-test, 2 sided|||||||.96
72445876|NCT03519581|144407240|SUPERIORITY|Two-tailed t-tests and mixed effects regression models||||||0.5|||||||t-test, 2 sided|||||||.50
72497645|NCT01512264|144525184|OTHER|||||||0.485|||||||t-test, 2 sided|||paired t- test between time point 1 and time point 4 for the 1 week of Sham Treatment + 2 weeks of nerTMS group and COWAT test were calculated. Cohen's d was calculated to determine the power of the test. The Cohen's d calculated for this test = -0.28.||||0.485
72497646|NCT01512264|144525184|OTHER|||||||0.864|||||||t-test, 2 sided|||paired t- test between time point 1 and time point 4 for the 2 weeks of Sham Treatment +1 week of nerTMS group and COWAT test were calculated. Cohen's d was calculated to determine the power of the test. The Cohen's d calculated for this test = -0.07.||||0.864
72560836|NCT01277510|144652159|SUPERIORITY_OR_OTHER_LEGACY||Difference (Cinacalcet - Placebo)|35.5||||0.017|TWO_SIDED|95.0|8.76|62.24|||Cochran-Mantel-Haenszel|Cochran- Mantel-Haenszel (CMH) test stratified by baseline age group (6 -\<12 years old or 12 - \<18 years old).||A hierarchical testing procedure was used to test the primary and biochemical secondary endpoints (Outcome Measures 1-5). The primary endpoint was tested at a significance level of 0.05. The four biochemical secondary endpoints were to be tested using Holm's method at 0.05 should the primary endpoint achieve a significant result.||62.24|8.76|0.017
72560837|NCT01277510|144652160|SUPERIORITY_OR_OTHER_LEGACY||Difference (Cinacalcet - Placebo)|3.46||||0.826|TWO_SIDED|95.0|-22.58|29.51|||Cochran-Mantel-Haenszel|Cochran- Mantel-Haenszel (CMH) test stratified by baseline age group (6 -\<12 years old or 12 - \<18 years old).||The secondary endpoint with the smallest p-value was first compared at a significance level of 0.0125. If the p-value was \> 0.0125, all 4 secondary endpoints were non-significant; if ≤ 0.0125, the null hypothesis for that endpoint was rejected. Next, the 2nd smallest p-value was compared at a level of 0.0167; if \> 0.0167, the remaining 3 endpoints were not significant, or, the null hypothesis of that endpoint was rejected. The other 2 endpoints were analyzed similarly, at 0.025 and 0.05.||29.51|-22.58|0.826
72560838|NCT01277510|144652161|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-3.7||||0.147|TWO_SIDED|95.0|-8.6|1.3|||ANCOVA|Baseline age group was used as covariate.|Cinacalcet-Placebo|The secondary endpoint with the smallest p-value was first compared at a significance level of 0.0125. If the p-value was \> 0.0125, all 4 secondary endpoints were non-significant; if ≤ 0.0125, the null hypothesis for that endpoint was rejected. Next, the 2nd smallest p-value was compared at a level of 0.0167; if \> 0.0167, the remaining 3 endpoints were not significant, or, the null hypothesis of that endpoint was rejected. The other 2 endpoints were analyzed similarly, at 0.025 and 0.05.||1.3|-8.6|0.147
72619312|NCT01654250|144769242|SUPERIORITY_OR_OTHER||LS Mean difference|8.3|STANDARD_ERROR_OF_MEAN|11.44||0.466|TWO_SIDED|95.0|-14.1|30.8|||Mixed Models Analysis|||Hour 13 post-dose (Problems correct): Treatment comparisons for observed scores were assessed using a mixed model repeated measures analysis, with treatment (NWP09/Placebo), study center, time point and time point by treatment interaction as main effects and participant intercept as a random effect.||30.8|-14.1|0.466
72619313|NCT00504556|144769251|SUPERIORITY_OR_OTHER|||||||0.367|TWO_SIDED||||||Fisher Exact|||All bleeds||||.367
72619314|NCT00504556|144769251|SUPERIORITY_OR_OTHER|||||||0.104|TWO_SIDED||||||Fisher Exact|||All bleeds||||.104
72619315|NCT00504556|144769251|SUPERIORITY_OR_OTHER|||||||0.864|TWO_SIDED||||||Fisher Exact|||All bleeds||||.864
72445877|NCT05229146|144407312|SUPERIORITY|||||||0.191||||||No adjustment for multiple comparisons.|t-test, 1 sided|t-statistic = .913, df = 10||One-sided paired-samples t-test comparing baseline to responses immediately following the intervention (approximately one week after baseline).||||.191
72445878|NCT05229146|144407312|SUPERIORITY|||||||0.043||||||Not adjusted for multiple comparisons.|t-test, 1 sided|t-statistic = 1.92, df = 9||One-sided paired-samples t-test comparing baseline to responses at two week follow-up (approximately four weeks after baseline).||||.043
72445879|NCT05229146|144407313|SUPERIORITY||Mean Difference (Final Values)|-1.03||||0.319|TWO_SIDED|||||No adjustments were made. DF = 15.|t-test, 2 sided|||Comparison is between future orientation subscale pre- and post-subscale scores.||||.319
72445880|NCT05229146|144407313|SUPERIORITY||Mean Difference (Final Values)|-0.711||||0.488|TWO_SIDED||||||t-test, 2 sided|No adjustments were made. DF = 15.||Comparison between immediate-orientation subscales.||||.488
72445881|NCT05229146|144407314|SUPERIORITY||Mean Difference (Final Values)|0.438||||0.34|ONE_SIDED||||||t-test, 1 sided|No adjustments were made. DF = 10.||Performed a paired-samples one-sided t-test comparing positive parenting before the intervention to after the intervention.||||.34
72445882|NCT05229146|144407314|SUPERIORITY||Mean Difference (Final Values)|-0.363||||0.362|ONE_SIDED||||||t-test, 1 sided|No adjustments were made. DF = 10.||Performed a one-sided paired-samples t-test to compare negative parenting before and after the intervention.||||.362
72445883|NCT05229146|144407315|SUPERIORITY||Mean Difference (Final Values)|-3.77|||<|0.001|ONE_SIDED||||||t-test, 1 sided|No adjustments, DF = 15||Used a one-sided paired samples t-test to examine changes in the parental involvement subscale from pre-intervention to post-intervention (approximately 4 weeks later).||||<.001
72445884|NCT05229146|144407315|SUPERIORITY||Median Difference (Final Values)|-1.14||||0.137|ONE_SIDED||||||t-test, 1 sided|||Used a one-sided paired samples t-test to examine changes in the positive parenting subscale from pre-intervention to post-intervention (approximately 4 weeks later).||||.137
72445885|NCT05229146|144407315|SUPERIORITY||Mean Difference (Final Values)|2.31||||0.018|ONE_SIDED||||||t-test, 1 sided|No adjustments; DF = 15.||Used a one-sided paired samples t-test to examine changes in the inconsistent discipline subscale from pre-intervention to post-intervention (approximately 4 weeks later).||||.018
72445886|NCT05229146|144407315|SUPERIORITY||Mean Difference (Final Values)|2.39||||0.015|ONE_SIDED||||||t-test, 1 sided|No adjustments; DF = 15.||Used a one-sided paired samples t-test to examine changes in the use of corporal punishment subscale from pre-intervention to post-intervention (approximately 4 weeks later).||||.015
72497647|NCT01512264|144525184|OTHER|||||||0.341|||||||t-test, 2 sided|||paired t- test between time point 1 and time point 4 for the control group and COWAT test were calculated. Cohen's d was calculated to determine the power of the test. The Cohen's d calculated for this test = -0.43.||||0.341
72497648|NCT01512264|144525185|OTHER|||||||0.899|||||||t-test, 2 sided|||paired t- test between time point 1 and time point 5 for the rTMS group and COWAT test were calculated. Cohen's d was calculated to determine the power of the test. The Cohen's d calculated for this test = -0.12.||||0.899
72497649|NCT01512264|144525185|OTHER|||||||0.519|||||||t-test, 2 sided|||paired t- test between time point 1 and time point 5 for the 1 week of Sham Treatment + 2 weeks of nerTMS group and COWAT test were calculated. Cohen's d was calculated to determine the power of the test. The Cohen's d calculated for this test = 0.19.||||0.519
72497650|NCT01512264|144525185|OTHER|||||||1|||||||t-test, 2 sided|||paired t- test between time point 1 and time point 5 for the 2 weeks of Sham Treatment +1 week of nerTMS group and COWAT test were calculated. Cohen's d was calculated to determine the power of the test. The Cohen's d calculated for this test = -0.09.||||1.000
72497651|NCT01512264|144525185|OTHER|||||||0.14|||||||t-test, 2 sided|||paired t- test between time point 1 and time point 5 for the control group and COWAT test were calculated. Cohen's d was calculated to determine the power of the test. The Cohen's d calculated for this test = -0.84.||||0.140
72497652|NCT01512264|144525187|OTHER|||||||0.52|||||||t-test, 2 sided|||paired t- test between time point 1 and time point 4 for the rTMS group and WAB test were calculated. Cohen's d was calculated to determine the power of the test. The Cohen's d calculated for this test = 0.24.||||0.520
72497653|NCT01512264|144525187|OTHER|||||||0.8|||||||t-test, 2 sided|||paired t- test between time point 1 and time point 4 for the 1 week of Sham Treatment + 2 weeks of nerTMS group and WAB test were calculated. Cohen's d was calculated to determine the power of the test. The Cohen's d calculated for this test = 0.97.||||0.800
72497654|NCT01512264|144525187|OTHER|||||||0.148|||||||t-test, 2 sided|||paired t- test between time point 1 and time point 4 for the 2 weeks of Sham Treatment +1 week of nerTMS group and WAB test were calculated. Cohen's d was calculated to determine the power of the test. The Cohen's d calculated for this test = -0.68.||||0.148
72497655|NCT01512264|144525187|OTHER|||||||0.787|||||||t-test, 2 sided|||paired t- test between time point 1 and time point 4 for the control group and WAB test were calculated. Cohen's d was calculated to determine the power of the test. The Cohen's d calculated for this test = 0.67.||||0.787
72497656|NCT01512264|144525188|OTHER|||||||0.239|||||||t-test, 2 sided|||paired t- test between time point 1 and time point 5 for the rTMS group and WAB test were calculated. Cohen's d was calculated to determine the power of the test. The Cohen's d calculated for this test = -3.12.||||0.239
72497657|NCT01512264|144525188|OTHER|||||||0.212|||||||t-test, 2 sided|||paired t- test between time point 1 and time point 5 for the 1 week of Sham Treatment + 2 weeks of nerTMS group and WAB test were calculated. Cohen's d was calculated to determine the power of the test. The Cohen's d calculated for this test = 2.71.||||0.212
72497658|NCT01512264|144525188|OTHER|||||||0.12|||||||t-test, 2 sided|||paired t- test between time point 1 and time point 5 for the 2 weeks of Sham Treatment +1 week of nerTMS group and WAB test were calculated. Cohen's d was calculated to determine the power of the test. The Cohen's d calculated for this test = -3.10.||||0.120
72497659|NCT01512264|144525188|OTHER|||||||0.263|||||||t-test, 2 sided|||paired t- test between time point 1 and time point 5 for the control group and WAB test were calculated. Cohen's d was calculated to determine the power of the test. The Cohen's d calculated for this test = -1.14.||||0.263
72497660|NCT02411747|144525198|NON_INFERIORITY_OR_EQUIVALENCE|Beta: 0.8, p significant if p \> 0.005||||||0.34|||||||t-test, 2 sided|||Independent samples t-test||||0.34
72497661|NCT00996203|144525202|SUPERIORITY_OR_OTHER||||||<|0.001||||||EQ-5D scores at Baseline Versus Week 24|t-test, 2 sided|||||||<0.001
72497662|NCT00996203|144525205|SUPERIORITY_OR_OTHER||||||<|0.001||||||General health at baseline Versus Week 24|t-test, 2 sided|||||||<0.001
72497663|NCT00996203|144525207|SUPERIORITY_OR_OTHER||||||<|0.001||||||Baseline Versus Week 24 DAS28 scores|t-test, 2 sided|||||||<0.001
72497664|NCT00996203|144525209|SUPERIORITY_OR_OTHER||||||<|0.001||||||Mean HAQ scores at Baseline Versus Week 24|t-test, 2 sided|||||||<0.001
72497665|NCT00848120|144525304|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA|||Week 24 versus baseline||||<0.001
72497666|NCT00848120|144525305|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA|||Week 24 versus baseline||||<0.001
72497667|NCT00848120|144525306|SUPERIORITY_OR_OTHER|||||||0.001|||||||ANOVA|||Week 24 versus baseline||||0.001
72497668|NCT01988090|144525316|SUPERIORITY|||||||0.7635|||||||Chi-squared|||||||0.7635
72619316|NCT00504556|144769251|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED||||||Fisher Exact|||All bleeds||||.002
72497669|NCT01988090|144525318|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
72497670|NCT01439945|144525328|SUPERIORITY_OR_OTHER|||||||0.13|||||||ANOVA|Weekly hot flash score was treated as a repeated measure for each patient.||||||0.13
72497671|NCT01439945|144525328|SUPERIORITY_OR_OTHER|||||||0.67|||||||ANOVA|Weekly hot flash score was treated as a repeated measure for each patient.||||||0.67
72497672|NCT01439945|144525329|SUPERIORITY_OR_OTHER|||||||0.25|||||||ANOVA|Weekly number of hot flashes were treated as a repeated measure for each patient.||||||0.25
72497673|NCT01439945|144525329|SUPERIORITY_OR_OTHER|||||||0.55||||||Weekly number of hot flashes were treated as a repeated measure for each patient.|ANOVA|||||||0.55
72497674|NCT01439945|144525332|SUPERIORITY_OR_OTHER|||||||1|||||||Wilcoxon (Mann-Whitney)|||||||1.00
72497675|NCT01439945|144525333|SUPERIORITY_OR_OTHER|||||||0.47|||||||Kruskal-Wallis|||||||0.47
72497676|NCT01439945|144525333|SUPERIORITY_OR_OTHER|||||||0.09|||||||Kruskal-Wallis|||||||0.09
72497677|NCT01412957|144525360|SUPERIORITY_OR_OTHER||Normal score|-2.59||||0.0096|||||||Log Rank|Log-rank test stratified by randomization factors: geographic region (Europe vs Asia vs rest of world) and ECOG performance status (0 or 1 vs 2).|A normal score \< 0 indicates fewer than expected events for the panitumumab plus BSC arm and therefore a longer time to event.|The primary hypothesis was that panitumumab plus BSC would improve overall survival compared to BSC alone. A comparison between treatments was performed using the log-rank test stratified by the randomization factors at a 5% significance level.||||0.0096
72619317|NCT00504556|144769251|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Fisher Exact|||Major or Clinically Relevant (CR) non-major bleeding||||1.000
72619318|NCT00504556|144769251|SUPERIORITY_OR_OTHER|||||||0.029|TWO_SIDED||||||Fisher Exact|||Major or Clinically Relevant (CR) non-major bleeding||||0.029
72560839|NCT01277510|144652162|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-5.3||||0.454|TWO_SIDED|95.0|-19.4|8.9|||ANCOVA|Baseline age group was used as covariate|Cinacalcet-Placebo|The secondary endpoint with the smallest p-value was first compared at a significance level of 0.0125. If the p-value was \> 0.0125, all 4 secondary endpoints were non-significant; if ≤ 0.0125, the null hypothesis for that endpoint was rejected. Next, the 2nd smallest p-value was compared at a level of 0.0167; if \> 0.0167, the remaining 3 endpoints were not significant, or, the null hypothesis of that endpoint was rejected. The other 2 endpoints were analyzed similarly, at 0.025 and 0.05.||8.9|-19.4|0.454
72445887|NCT05229146|144407315|SUPERIORITY||Mean Difference (Final Values)|2.23||||0.021|ONE_SIDED||||||t-test, 1 sided|||Used a one-sided paired samples t-test to examine changes in the poor parental monitoring/supervision subscale from pre-intervention to post-intervention (approximately 4 weeks later).||||.021
72445888|NCT05229146|144407316|SUPERIORITY||Mean Difference (Final Values)|0.878||||0.197|ONE_SIDED||||||t-test, 1 sided|No adjustments; DF = 15||Used a one-sided paired-samples t-test to examine changes in emotion regulation subscale from pre-intervention to post-intervention.||||.197
72445889|NCT05229146|144407316|SUPERIORITY||Mean Difference (Final Values)|0.857||||0.203|ONE_SIDED||||||t-test, 1 sided|No adjustments, DF = 15.||Used a one-sided paired-samples t-test to examine changes in lability/negativity subscale from pre-intervention to post-intervention.||||.203
72445890|NCT03850678|144407345|SUPERIORITY|||||||0.774|||||||ANOVA|||This analysis examined Q10 for those participants who completed the compression speed experiment (instant, fast, slow).||||.774
72445891|NCT03850678|144407345|SUPERIORITY||||||<|0.001|||||||ANOVA|||This analysis examined Q10 for those participants who completed the compression channel conditions (4, 8, 16).||||<.001
72445892|NCT03850678|144407345|SUPERIORITY|||||||0.167|||||||ANOVA|||This analysis compared Q10 for those participants who completed the unaided and aided conditions.||||.167
72445893|NCT03850678|144407346|SUPERIORITY|||||||0.741|||||||ANOVA|||Statistical analysis of number of compression channels (unaided, 4 channel, 16 channels)||||.741
72445894|NCT03850678|144407346|SUPERIORITY|||||||0.062||||||Due to Levene's Test for Equality of Variances, equal variances were not assumed.|t-test, 1 sided|||Spatial Release from Masking, unaided.||||.062
72619319|NCT00504556|144769251|SUPERIORITY_OR_OTHER|||||||0.807|TWO_SIDED||||||Fisher Exact|||Major or Clinically Relevant (CR) non-major bleeding||||0.807
72619320|NCT00504556|144769251|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED||||||Fisher Exact|||Major or Clinically Relevant (CR) non-major bleeding||||0.002
72445895|NCT03850678|144407347|SUPERIORITY|||||||0.805|||||||Regression, Linear|||Linear regression of score for the reading span (independent variable) to Q10 (dependent variable, 16 channel compression condition) for the participants who completed the compression channel experiment.||||.805
72445896|NCT04640298|144407352|OTHER||||||<|0.0001||||||P-Value was calculated|ANOVA|||||||<0.0001
72445897|NCT04640298|144407353|OTHER||||||<|0.0001||||||P-Value was calculated|ANOVA|||||||<0.0001
72445898|NCT04640298|144407354|OTHER||||||<|0.0001||||||P-Value was calculated|ANOVA|||||||<0.0001
72445899|NCT03891667|144407376|SUPERIORITY||Odds Ratio (OR)|4.0|||||TWO_SIDED|95.0|0.21|75.66||||||||75.66|.21|
72445900|NCT03891667|144407377|SUPERIORITY||Odds Ratio (OR)|0.67|||||TWO_SIDED|95.0|0.05|9.47||||||||9.47|0.05|
72619321|NCT00504556|144769251|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Fisher Exact|||Major bleeds||||1.000
72445901|NCT00534469|144407391|OTHER|Two-sided test.||||||0.43||||||Log-rank test (Mantel-Haenszel test). This p-value is not adjusted for multiple comparisons. The a priori threshold for statistical significance is 0.05.|Log Rank|||Null hypothesis: All four groups are drawn from the same distribution. Alternative hypothesis: At least one of the groups has measurably different survival from the others.||||0.43
72445902|NCT05717907|144407396|SUPERIORITY|||||||1|||||||Chi-squared|||||||1.000
72445903|NCT04166773|144407401|SUPERIORITY||Odds Ratio (OR)|7.45|||<|0.001|TWO_SIDED|95.0|2.27|24.44|||Regression, Logistic||Odds ratio, Confidence Interval (CI), and p-value for endpoint measures are from logistic regression model with baseline diabetes status, region, treatment as factors.|||24.44|2.27|<0.001
72445904|NCT04166773|144407401|SUPERIORITY||Odds Ratio (OR)|11.86|||<|0.001|TWO_SIDED|95.0|3.59|39.11|||Regression, Logistic||Odds ratio, CI, and p-value for endpoint measures are from logistic regression model with baseline diabetes status, region, treatment as factors.|||39.11|3.59|<0.001
72445905|NCT04166773|144407401|SUPERIORITY||Odds Ratio (OR)|19.63|||<|0.001|TWO_SIDED|95.0|5.73|67.25|||Regression, Logistic||Odds ratio, CI, and p-value for endpoint measures are from logistic regression model with baseline diabetes status, region, treatment as factors.|||67.25|5.73|<0.001
72445906|NCT04166773|144407402|SUPERIORITY||Odds Ratio (OR)|3.01||||0.025|TWO_SIDED|95.0|1.15|7.9|||Regression, Logistic||Odds ratio, CI, and p-value for endpoint measures are from logistic regression model with baseline diabetes status, region, treatment as factors.|||7.90|1.15|0.025
72445907|NCT04166773|144407402|SUPERIORITY||Odds Ratio (OR)|2.37||||0.074|TWO_SIDED|95.0|0.92|6.13|||Regression, Logistic||Odds ratio, CI, and p-value for endpoint measures are from logistic regression model with baseline diabetes status, region, treatment as factors|||6.13|0.92|0.074
72445908|NCT04166773|144407402|SUPERIORITY||Odds Ratio (OR)|2.47||||0.063|TWO_SIDED|95.0|0.95|6.4|||Regression, Logistic||Odds ratio, CI, and p-value for endpoint measures are from logistic regression model with baseline diabetes status, region, treatment as factors.|||6.40|0.95|0.063
72445909|NCT04166773|144407403|SUPERIORITY||Odds Ratio (OR)|0.91||||0.893|TWO_SIDED|95.0|0.25|3.4|||Regression, Logistic||Odds ratio, CI, and p-value for endpoint measures are from logistic regression model with baseline diabetes status, region, treatment as factors.|||3.40|0.25|0.893
72445910|NCT04166773|144407403|SUPERIORITY||Odds Ratio (OR)|0.73||||0.647|TWO_SIDED|95.0|0.18|2.87|||Regression, Logistic||Odds ratio, CI, and p-value for endpoint measures are from logistic regression model with baseline diabetes status, region, treatment as factors.|||2.87|0.18|0.647
72445911|NCT04166773|144407403|SUPERIORITY||Odds Ratio (OR)|0.39||||0.246|TWO_SIDED|95.0|0.08|1.91|||Regression, Logistic||Odds ratio, CI, and p-value for endpoint measures are from logistic regression model with baseline diabetes status, region, treatment as factors.|||1.91|0.08|0.246
72445912|NCT04166773|144407404|SUPERIORITY||Odds Ratio (OR)|6.94|||<|0.001|TWO_SIDED|95.0|2.41|20.0|||Regression, Logistic||Odds ratio, CI, and p-value for endpoint measures are from logistic regression model with baseline diabetes status, region, treatment as factors.|||20.00|2.41|<0.001
72619322|NCT00504556|144769251|SUPERIORITY_OR_OTHER|||||||0.119|TWO_SIDED||||||Fisher Exact|||Major bleeds||||0.119
72560840|NCT01277510|144652163|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-10.0||||0.117|TWO_SIDED|95.0|-22.5|2.6|||ANCOVA|Baseline age group was used as covariate.|Cinacalcet-Placebo|The secondary endpoint with the smallest p-value was first compared at a significance level of 0.0125. If the p-value was \> 0.0125, all 4 secondary endpoints were non-significant; if ≤ 0.0125, the null hypothesis for that endpoint was rejected. Next, the 2nd smallest p-value was compared at a level of 0.0167; if \> 0.0167, the remaining 3 endpoints were not significant, or, the null hypothesis of that endpoint was rejected. The other 2 endpoints were analyzed similarly, at 0.025 and 0.05.||2.6|-22.5|0.117
72560841|NCT01277510|144652164|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.2||||0.896|TWO_SIDED|95.0|-3.1|3.6||No adjustments for multiplicity were made.|ANCOVA|Baseline age group was used as covariate.|Cinacalcet-Placebo|||3.6|-3.1|0.896
72560842|NCT01277510|144652166|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.8||||0.854|TWO_SIDED|95.0|-9.4|7.9|||ANCOVA|Baseline age group was used as covariate.|Cinacalcet-Placebo|||7.9|-9.4|0.854
72445913|NCT04166773|144407404|SUPERIORITY||Odds Ratio (OR)|10.46|||<|0.001|TWO_SIDED|95.0|3.36|32.61|||Regression, Logistic||Odds ratio, CI, and p-value for endpoint measures are from logistic regression model with baseline diabetes status, region, treatment as factors.|||32.61|3.36|<0.001
72445914|NCT04166773|144407404|SUPERIORITY||Odds Ratio (OR)|12.85|||<|0.001|TWO_SIDED|95.0|3.87|42.65|||Regression, Logistic||Odds ratio, CI, and p-value for endpoint measures are from logistic regression model with baseline diabetes status, region, treatment as factors.|||42.65|3.87|<0.001
72445915|NCT04166773|144407405|SUPERIORITY||LS Mean difference (Final Values)|-8.81|STANDARD_ERROR_OF_MEAN|1.632|<|0.001|TWO_SIDED|95.0|-12.04|-5.58|||Mixed Models Analysis|||||-5.58|-12.04|<0.001
72445916|NCT04166773|144407405|SUPERIORITY||LS Mean difference (Final Values)|-8.83|STANDARD_ERROR_OF_MEAN|1.566|<|0.001|TWO_SIDED|95.0|-11.93|-5.73|||Mixed Models Analysis|||||-5.73|-11.93|<0.001
72445917|NCT04166773|144407405|SUPERIORITY||LS Mean difference (Final Values)|-10.02|STANDARD_ERROR_OF_MEAN|1.591|<|0.001|TWO_SIDED|95.0|-13.17|-6.87|||Mixed Models Analysis|||||-6.87|-13.17|<0.001
72445918|NCT04166773|144407406|SUPERIORITY||LS Mean difference (Final Values)|-10.42|STANDARD_ERROR_OF_MEAN|1.976|<|0.001|TWO_SIDED|95.0|-14.32|-6.52|||Mixed Models Analysis|||||-6.52|-14.32|<0.001
72445919|NCT04166773|144407406|SUPERIORITY||LS Mean difference (Final Values)|-13.19|STANDARD_ERROR_OF_MEAN|1.96|<|0.001|TWO_SIDED|95.0|-17.05|-9.32|||Mixed Models Analysis|||||-9.32|-17.05|<0.001
72445920|NCT04166773|144407406|SUPERIORITY||LS Mean difference (Final Values)|-16.84|STANDARD_ERROR_OF_MEAN|1.957|<|0.001|TWO_SIDED|95.0|-20.71|-12.98|||Mixed Models Analysis|||||-12.98|-20.71|<0.001
72445921|NCT04717492|144407464|OTHER||Cox Proportional Hazard|1.01||||0.962|TWO_SIDED|95.0|0.66|1.54||No adjustments for multiplicity were performed.|Regression, Cox|Cox proportional hazard model with inverse probability of treatment weighting as described in primary manuscript.||Time to death, or first hospitalization or revascularization event was analyzed using cox proportional hazards models with inverse probability of treatment weighting (IPTW) to reduce confounding. Missing data were imputed using multivariate imputation by chained equations with predictive mean matching.||1.54|0.66|0.962
72445922|NCT04717492|144407466|OTHER||Cox Proportional Hazard|1.11||||0.694|TWO_SIDED|95.0|0.65|1.92||No adjustments for multiplicity were performed.|Regression, Cox|Cox proportional hazard model with inverse probability of treatment weighting as described in primary manuscript.||Time to CVD-related death or hospitalization/revascularization was analyzed using cox proportional hazards models with inverse probability of treatment weighting (IPTW) to reduce confounding. Missing data were imputed using multivariate imputation by chained equations with predictive mean matching.||1.92|0.65|0.694
72560843|NCT02224053|144652210|NON_INFERIORITY_OR_EQUIVALENCE|90% CIs of geometric mean ratios being within 80% to 125%|Geometric mean ratio|106.66|||||TWO_SIDED|90.0|100.26|113.46|||||AZD9291+omeprazole / AZD9291 alone|Study sized so experiment-wise power for the 90% CIs of geometric mean ratios for both AUC and Cmax of AZD9291 being within 80% to 125% was 90% (95% for each parameter). Within subject CV assumed to be 23%. 5% change in exposure also assumed.||113.46|100.26|
72560844|NCT02224053|144652211|NON_INFERIORITY_OR_EQUIVALENCE|90% CIs of geometric mean ratios being within 80% to 125%|Geometric mean ratio|101.65|||||TWO_SIDED|90.0|94.65|109.16|||||AZD9291+omeprazole / AZD9291 alone|Study sized so experiment-wise power for the 90% CIs of geometric mean ratios for both AUC and Cmax of AZD9291 being within 80% to 125% was 90% (95% for each parameter). Within subject CV assumed to be 23%. 5% change in exposure also assumed.||109.16|94.65|
72560845|NCT02224053|144652220|NON_INFERIORITY_OR_EQUIVALENCE|90% CIs of geometric mean ratios being within 80% to 125%|Geometric mean ratio|94.79|||||TWO_SIDED|90.0|88.77|101.21||||||AZ5104||101.21|88.77|
72560846|NCT02224053|144652220|NON_INFERIORITY_OR_EQUIVALENCE|90% CIs of geometric mean ratios being within 80% to 125%|Geomteric mean ratio|89.7|||||TWO_SIDED|90.0|83.89|95.91||||||AZ7550||95.91|83.89|
72445923|NCT04717492|144407468|OTHER||Cox Proportional Hazard|0.75||||0.476|TWO_SIDED|95.0|0.34|1.66||No adjustments for multiplicity were performed.|Regression, Cox|Cox proportional hazard model with inverse probability of treatment weighting as described in primary manuscript.||Time to respiratory/COPD-related death or hospitalization was analyzed using Cox proportional hazards models with inverse probability of treatment weighting (IPTW) to reduce confounding. Missing data were imputed using multivariate imputation by chained equations with predictive mean matching.||1.66|0.34|0.476
72445924|NCT05093829|144407519|NON_INFERIORITY|NmCV-5 will be deemed non-inferior to MenACWY-TT for serogroup A if the lower limit of the 95% confidence interval for the difference in proportion (NmCV-5 minus MenACWY-TT) excludes -0.10 (-10%). Confidence Intervals are calculated using the Miettinen-Nurminen method. Difference in proportions and confidence intervals are reported as percentages (number of infants per 100).|Difference in proportions|0.0|||||TWO_SIDED|95.0|-1.0|2.0||||||For serogroup A, the proportion of infants with a seroprotective response to MenACWY-TT is subtracted from the proportion of infants with a seroprotective response to NmCV-5 to determine the difference in proportions.||2.0|-1.0|
72445925|NCT05093829|144407519|NON_INFERIORITY|NmCV-5 will be deemed non-inferior to MenACWY-TT for serogroup A if the lower limit of the 95% confidence interval for the difference in proportion (NmCV-5 minus MenACWY-TT) excludes -0.10 (-10%). Confidence Intervals are calculated using the Miettinen-Nurminen method. Difference in proportions and confidence intervals are reported as percentages (number of infants per 100).|Difference in proportions|0.8|||||TWO_SIDED|95.0|-0.6|3.7||||||For serogroup A, the proportion of infants with a seroprotective response to MenACWY-TT is subtracted from the proportion of infants with a seroprotective response to NmCV-5 to determine the difference in proportions.||3.7|-0.6|
72445926|NCT05093829|144407519|NON_INFERIORITY|NmCV-5 will be deemed non-inferior to MenACWY-TT for serogroup C if the lower limit of the 95% confidence interval for the difference in proportion (NmCV-5 minus MenACWY-TT) excludes -0.10 (-10%). Confidence Intervals are calculated using the Miettinen-Nurminen method. Difference in proportions and confidence intervals are reported as percentages (number of infants per 100).|Difference in proportions|-0.5|||||TWO_SIDED|95.0|-2.3|1.9||||||For serogroup C, the proportion of infants with a seroprotective response to MenACWY-TT is subtracted from the proportion of infants with a seroprotective response to NmCV-5 to determine the difference in proportions.||1.9|-2.3|
72445927|NCT05093829|144407519|NON_INFERIORITY|NmCV-5 will be deemed non-inferior to MenACWY-TT for serogroup C if the lower limit of the 95% confidence interval for the difference in proportion (NmCV-5 minus MenACWY-TT) excludes -0.10 (-10%). Confidence Intervals are calculated using the Miettinen-Nurminen method. Difference in proportions and confidence intervals are reported as percentages (number of infants per 100).|Difference in proportions|-0.8|||||TWO_SIDED|95.0|-3.3|2.5||||||For serogroup C, the proportion of infants with a seroprotective response to MenACWY-TT is subtracted from the proportion of infants with a seroprotective response to NmCV-5 to determine the difference in proportions.||2.5|-3.3|
72445928|NCT05093829|144407519|NON_INFERIORITY|NmCV-5 will be deemed non-inferior to MenACWY-TT for serogroup W if the lower limit of the 95% confidence interval for the difference in proportion (NmCV-5 minus MenACWY-TT) excludes -0.10 (-10%). Confidence Intervals are calculated using the Miettinen-Nurminen method. Difference in proportions and confidence intervals are reported as percentages (number of infants per 100).|Difference in proportions|-3.0|||||TWO_SIDED|95.0|-6.3|0.8||||||For serogroup W, the proportion of infants with a seroprotective response to MenACWY-TT is subtracted from the proportion of infants with a seroprotective response to NmCV-5 to determine the difference in proportions.||0.8|-6.3|
72445929|NCT05093829|144407519|NON_INFERIORITY|NmCV-5 will be deemed non-inferior to MenACWY-TT for serogroup W if the lower limit of the 95% confidence interval for the difference in proportion (NmCV-5 minus MenACWY-TT) excludes -0.10 (-10%). Confidence Intervals are calculated using the Miettinen-Nurminen method. Difference in proportions and confidence intervals are reported as percentages (number of infants per 100).|Difference in proportions|0.3|||||TWO_SIDED|95.0|-1.8|3.5||||||For serogroup W, the proportion of infants with a seroprotective response to MenACWY-TT is subtracted from the proportion of infants with a seroprotective response to NmCV-5 to determine the difference in proportions.||3.5|-1.8|
72445930|NCT05093829|144407519|NON_INFERIORITY|NmCV-5 will be deemed non-inferior to MenACWY-TT for serogroup Y if the lower limit of the 95% confidence interval for the difference in proportion (NmCV-5 minus MenACWY-TT) excludes -0.10 (-10%). Confidence Intervals are calculated using the Miettinen-Nurminen method. Difference in proportions and confidence intervals are reported as percentages (number of infants per 100).|Difference in proportions|-3.0|||||TWO_SIDED|95.0|-5.4|-0.4||||||For serogroup Y, the proportion of infants with a seroprotective response to MenACWY-TT is subtracted from the proportion of infants with a seroprotective response to NmCV-5 to determine the difference in proportions.||-0.4|-5.4|
72445931|NCT05093829|144407519|NON_INFERIORITY|NmCV-5 will be deemed non-inferior to MenACWY-TT for serogroup Y if the lower limit of the 95% confidence interval for the difference in proportion (NmCV-5 minus MenACWY-TT) excludes -0.10 (-10%). Confidence Intervals are calculated using the Miettinen-Nurminen method. Difference in proportions and confidence intervals are reported as percentages (number of infants per 100).|Difference in proportions|1.4|||||TWO_SIDED|95.0|-0.6|4.8||||||For serogroup Y, the proportion of infants with a seroprotective response to MenACWY-TT is subtracted from the proportion of infants with a seroprotective response to NmCV-5 to determine the difference in proportions.||4.8|-0.6|
72445932|NCT05093829|144407520|NON_INFERIORITY|NmCV-5 will be deemed non-inferior to MenACWY-TT for serogroup X if the lower limit of the 95% confidence interval (CI) for the difference in proportion (NmCV-5 minus MenACWY-TT) excludes -0.10 (-10%). The CI is estimated using bootstrap resampling stratified by vaccine arm, and the 95% CI is estimated as the interval between the 2.5th and 97.5th percentiles of the bootstrap empirical distribution. The difference in proportions and CI are reported as percentages (number of infants per 100).|Difference in proportions|2.3|||||TWO_SIDED|95.0|0.3|4.7||||||For the 9-months study age group, the proportion of infants with a seroprotective response to MenACWY-TT in serogroup W is subtracted from the proportion of infants with a seroprotective response to NmCV-5 in serogroup X to determine the difference in proportions.||4.7|0.3|
72445933|NCT05093829|144407520|NON_INFERIORITY|NmCV-5 will be deemed non-inferior to MenACWY-TT for serogroup X if the lower limit of the 95% confidence interval (CI) for the difference in proportion (NmCV-5 minus MenACWY-TT) excludes -0.10 (-10%). The CI is estimated using bootstrap resampling stratified by vaccine arm, and the 95% CI is estimated as the interval between the 2.5th and 97.5th percentiles of the bootstrap empirical distribution. The difference in proportions and CI are reported as percentages (number of infants per 100).|Difference in proportions|1.9|||||TWO_SIDED|95.0|0.004|4.4||||||For the 15-months study age group, the proportion of infants with a seroprotective response to MenACWY-TT in serogroup Y is subtracted from the proportion of infants with a seroprotective response to NmCV-5 in serogroup X to determine the difference in proportions.||4.4|0.004|
72445934|NCT05093829|144407524|SUPERIORITY|NmCV-5 will be deemed superior to MenACWY-TT for serogroup X if the lower limit of the 95% confidence interval for the difference in proportion (NmCV-5 minus MenACWY-TT) excludes 0.30 (30%). Confidence Intervals are calculated using the Miettinen-Nurminen method. The difference in proportions and CI are reported as percentages (number of infants per 100).|Difference in proportions|82.5|||||TWO_SIDED|95.0|76.4|87.2||||||For serogroup X, the proportion of infants with a seroprotective response to MenACWY-TT is subtracted from the proportion of infants with a seroprotective response to NmCV-5 to determine the difference in proportions.||87.2|76.4|
72445935|NCT05093829|144407524|SUPERIORITY|NmCV-5 will be deemed superior to MenACWY-TT for serogroup X if the lower limit of the 95% confidence interval for the difference in proportion (NmCV-5 minus MenACWY-TT) excludes 0.30 (30%). Confidence Intervals are calculated using the Miettinen-Nurminen method. The difference in proportions and CI are reported as percentages (number of infants per 100).|Difference in proportions|68.4|||||TWO_SIDED|95.0|61.3|74.7||||||For serogroup X, the proportion of infants with a seroprotective response to MenACWY-TT is subtracted from the proportion of infants with a seroprotective response to NmCV-5 to determine the difference in proportions.||74.7|61.3|
72560847|NCT02224053|144652221|NON_INFERIORITY_OR_EQUIVALENCE|90% CIs of geometric mean ratios being within 80% to 125%|Geometric mean ratio|102.32|||||TWO_SIDED|90.0|96.87|108.07|||||AZD9291+omeprazole / AZD9291 alone|AZ5104||108.07|96.87|
72445936|NCT05093829|144407525|NON_INFERIORITY|The NmCV-5 co-administered MR vaccine will be deemed non-inferior to the MenACWY-TT co-administered MR vaccine in eliciting seropositive response to measles if the lower limit of the 95% confidence interval for the difference in proportions excludes -0.10 (-10%). Confidence Intervals are calculated using the Miettinen-Nurminen method. The difference in proportions and CI are reported as percentages (number of infants per 100).|Difference in proportions|0.0|||||TWO_SIDED|95.0|-1.0|2.0||||||For this comparison, the proportion of infants with a seropositive response to measles vaccine in the MenACWY-TT arm is subtracted from the proportion of infants with a seropositive response to measles vaccine in the NmCV-5 arm to determine the difference in proportions.||2.0|-1.0|
72445937|NCT05093829|144407525|NON_INFERIORITY|The NmCV-5 co-administered MR vaccine will be deemed non-inferior to the MenACWY-TT co-administered MR vaccine in eliciting seropositive response to measles if the lower limit of the 95% confidence interval for the difference in proportions excludes -0.10 (-10%). Confidence Intervals are calculated using the Miettinen-Nurminen method. The difference in proportions and CI are reported as percentages (number of infants per 100).|Difference in proportions|0.0|||||TWO_SIDED|95.0|-1.0|2.1||||||For this comparison, the proportion of infants with a seropositive response to measles vaccine in the MenACWY-TT arm is subtracted from the proportion of infants with a seropositive response to measles vaccine in the NmCV-5 arm to determine the difference in proportions.||2.1|-1.0|
72445938|NCT05093829|144407526|NON_INFERIORITY|The NmCV-5 co-administered MR vaccine will be deemed non-inferior to the MenACWY-TT co-administered MR vaccine in eliciting seropositive response to rubella if the lower limit of the 95% confidence interval for the difference in proportions excludes -0.10 (-10%). Confidence Intervals are calculated using the Miettinen-Nurminen method. The difference in proportions and CI are reported as percentages (number of infants per 100).|Difference in proportions|-4.3|||||TWO_SIDED|95.0|-10.5|2.6||||||For this comparison, the proportion of infants with a seropositive response to rubella vaccine in the MenACWY-TT arm is subtracted from the proportion of infants with a seropositive response to rubella vaccine in the NmCV-5 arm to determine the difference in proportions.||2.6|-10.5|
72445939|NCT05093829|144407526|NON_INFERIORITY|The NmCV-5 co-administered MR vaccine will be deemed non-inferior to the MenACWY-TT co-administered MR vaccine in eliciting seropositive response to rubella if the lower limit of the 95% confidence interval for the difference in proportions excludes -0.10 (-10%). Confidence Intervals are calculated using the Miettinen-Nurminen method. The difference in proportions and CI are reported as percentages (number of infants per 100).|Difference in proportions|0.0|||||TWO_SIDED|95.0|-1.0|2.1||||||For this comparison, the proportion of infants with a seropositive response to rubella vaccine in the MenACWY-TT arm is subtracted from the proportion of infants with a seropositive response to rubella vaccine in the NmCV-5 arm to determine the difference in proportions.||2.1|-1.0|
72445940|NCT05093829|144407527|NON_INFERIORITY|The NmCV-5 co-administered yellow fever vaccine will be deemed non-inferior to the MenACWY-TT co-administered yellow fever vaccine in eliciting seroprotective response to yellow fever if the lower limit of the 95% confidence interval for the difference in proportions excludes -0.10 (-10%). Confidence Intervals are calculated using the Miettinen-Nurminen method. The difference in proportions and CI are reported as percentages (number of infants per 100).|Difference in proportions|-1.9|||||TWO_SIDED|95.0|-4.2|0.6||||||For this comparison, the proportion of infants with a seroprotective response to yellow fever vaccine in the MenACWY-TT arm is subtracted from the proportion of infants with a seroprotective response to yellow fever vaccine in the NmCV-5 arm to determine the difference in proportions.||0.6|-4.2|
72445941|NCT05093829|144407528|OTHER||Ratio of geometric mean titers|1.0|||||TWO_SIDED|95.0|0.8|1.3|||||NmCV-5 divided by MenACWY-TT|For serogroup A, the point and interval estimates for the Geometric Mean Titer (GMT) ratio will be obtained from a back transformation (exponentiation) of the estimated mean ratio of the log-transformed rSBA titers. The GMT ratio of rSBA titers at Day 29 is calculated for the NmCV-5 arm relative to the MenACWY-TT arm.||1.3|0.8|
72445942|NCT05093829|144407528|OTHER||Ratio of geometric mean titers|1.2|||||TWO_SIDED|95.0|1.0|1.6|||||NmCV-5 divided by MenACWY-TT|For serogroup A, the point and interval estimates for the Geometric Mean Titer (GMT) ratio will be obtained from a back transformation (exponentiation) of the estimated mean ratio of the log-transformed rSBA titers. The GMT ratio of rSBA titers at Day 29 is calculated for the NmCV-5 arm relative to the MenACWY-TT arm.||1.6|1.0|
72445943|NCT05093829|144407528|OTHER||Ratio of geometric mean titers|0.5|||||TWO_SIDED|95.0|0.4|0.6|||||NmCV-5 divided by MenACWY-TT|For serogroup C, the point and interval estimates for the Geometric Mean Titer (GMT) ratio will be obtained from a back transformation (exponentiation) of the estimated mean ratio of the log-transformed rSBA titers. The GMT ratio of rSBA titers at Day 29 is calculated for the NmCV-5 arm relative to the MenACWY-TT arm.||0.6|0.4|
72445944|NCT05093829|144407528|OTHER||Ratio of geometric mean titers|0.4|||||TWO_SIDED|95.0|0.3|0.5|||||NmCV-5 divided by MenACWY-TT|For serogroup C, the point and interval estimates for the Geometric Mean Titer (GMT) ratio will be obtained from a back transformation (exponentiation) of the estimated mean ratio of the log-transformed rSBA titers. The GMT ratio of rSBA titers at Day 29 is calculated for the NmCV-5 arm relative to the MenACWY-TT arm.||0.5|0.3|
72445945|NCT05093829|144407528|OTHER||Ratio of geometric mean titers|0.9|||||TWO_SIDED|95.0|0.6|1.3|||||NmCV-5 divided by MenACWY-TT|For serogroup W, the point and interval estimates for the Geometric Mean Titer (GMT) ratio will be obtained from a back transformation (exponentiation) of the estimated mean ratio of the log-transformed rSBA titers. The GMT ratio of rSBA titers at Day 29 is calculated for the NmCV-5 arm relative to the MenACWY-TT arm.||1.3|0.6|
72560848|NCT02224053|144652221|NON_INFERIORITY_OR_EQUIVALENCE|90% CIs of geometric mean ratios being within 80% to 125%|Geometric mean ratio|94.03|||||TWO_SIDED|90.0|89.92|98.33||||||AZ7550||98.33|89.92|
72560849|NCT01898598|144652234|SUPERIORITY_OR_OTHER||Difference in Clinical Response Rates|-21.8|||||TWO_SIDED|95.0|-71.6|32.1||||||The 95 % confidence interval (CI) for the difference in response rates was computed using the exact unconditional confidence limits method.||32.1|-71.6|
72560850|NCT01898598|144652235|SUPERIORITY_OR_OTHER||Percentage Difference|-40.0|||||TWO_SIDED|95.0|-85.3|14.2||||||||14.2|-85.3|
72560851|NCT01499160|144652252|OTHER|Not done due to low accrual||||||||||||Not done due to low accrual|Not done due to low accrual|Not done due to low accrual||Not done due to low accrual|Not done due to low accrual|||
72560852|NCT00593827|144652253|SUPERIORITY_OR_OTHER|||||||0.03|||||||Log Rank|||||||0.03
72560853|NCT00593827|144652254|SUPERIORITY_OR_OTHER|||||||0.05|||||||Log Rank|||||||0.05
72560854|NCT00593827|144652257|SUPERIORITY_OR_OTHER|||||||0.11|||||||Log Rank|||||||0.11
72619323|NCT00504556|144769251|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Fisher Exact|||Major bleeds||||1.000
72445946|NCT05093829|144407528|OTHER||Ratio of geometric mean titers|1.6|||||TWO_SIDED|95.0|1.1|2.1|||||NmCV-5 divided by MenACWY-TT|For serogroup W, the point and interval estimates for the Geometric Mean Titer (GMT) ratio will be obtained from a back transformation (exponentiation) of the estimated mean ratio of the log-transformed rSBA titers. The GMT ratio of rSBA titers at Day 29 is calculated for the NmCV-5 arm relative to the MenACWY-TT arm.||2.1|1.1|
72445947|NCT05093829|144407528|OTHER||Ratio of geometric mean titers|0.7|||||TWO_SIDED|95.0|0.6|1.0|||||NmCV-5 divided by MenACWY-TT|For serogroup Y, the point and interval estimates for the Geometric Mean Titer (GMT) ratio will be obtained from a back transformation (exponentiation) of the estimated mean ratio of the log-transformed rSBA titers. The GMT ratio of rSBA titers at Day 29 is calculated for the NmCV-5 arm relative to the MenACWY-TT arm.||1.0|0.6|
72445948|NCT05093829|144407528|OTHER||Ratio of geometric mean titers|1.0|||||TWO_SIDED|95.0|0.8|1.3|||||NmCV-5 divided by MenACWY-TT|For serogroup Y, the point and interval estimates for the Geometric Mean Titer (GMT) ratio will be obtained from a back transformation (exponentiation) of the estimated mean ratio of the log-transformed rSBA titers. The GMT ratio of rSBA titers at Day 29 is calculated for the NmCV-5 arm relative to the MenACWY-TT arm.||1.3|0.8|
72497678|NCT01412957|144525361|SUPERIORITY_OR_OTHER||Normal score|-6.08|||<|0.0001|||||||Log Rank|Log-rank test stratified by randomization factors: geographic region (Europe vs Asia vs rest of world) and ECOG performance status (0 or 1 vs 2).|A normal score \< 0 indicates fewer than expected events for the panitumumab plus BSC arm and therefore a longer time to event.|PFS in the ITT Analysis Set was tested at a significance level of 5% conditional on a significant treatment effect on overall survival in the ITT Analysis Set.||||<0.0001
72497679|NCT01412957|144525362|SUPERIORITY_OR_OTHER||Normal score|-2.47||||0.0135|||||||Log Rank|Log-rank test stratified by randomization factors: geographic region (Europe vs Asia vs rest of world) and ECOG performance status (0 or 1 vs 2).|A normal score \< 0 indicates fewer than expected events for the panitumumab plus BSC arm and therefore a longer time to event.|Overall survival in the Wild-type RAS Efficacy Analysis Set was compared at a significance level of 5% conditional on a significant treatment effect for progression-free survival in the ITT Analysis Set.||||0.0135
72560855|NCT00633022|144652267|SUPERIORITY||Mean Difference (Final Values)|-0.04||||0.4519|TWO_SIDED|95.0|-0.14|0.06|||ANCOVA|ANCOVA model, fitting fixed effect treatment term, and including baseline TBR value as a covariate.ANCOVA model, fitting fixed effect treatment term,|The point estimate was calculated as least square mean difference (final values) of Losmapimod 7.5 mg twice daily and Placebo.|Losmapimod 7.5 mg BID versus Placebo||0.06|-0.14|0.4519
72560856|NCT00633022|144652267|SUPERIORITY||Mean Difference (Final Values)|-0.02||||0.5789|TWO_SIDED|95.0|-0.11|0.06|||ANCOVA|ANCOVA model, fitting fixed effect treatment term, and including baseline TBR value as a covariate.|The point estimate was calculated as least square mean difference (final values) of Losmapimod 7.5 mg once daily and Placebo.|Losmapimod 7.5 mg once daily versus Placebo||0.06|-0.11|0.5789
72560857|NCT00633022|144652268|SUPERIORITY||Mean Difference (Final Values)|-0.02||||0.6986|TWO_SIDED|95.0|-0.15|0.1|||ANCOVA|ANCOVA model, fitting fixed effect treatment term, and including baseline TBR value as a covariate.|The point estimate was calculated as least square mean difference (final values) of Losmapimod 7.5 mg twice daily and Placebo.|Losmapimod 7.5 mg twice daily versus placebo||0.10|-0.15|0.6986
72560858|NCT00633022|144652268|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.9486|TWO_SIDED|95.0|-0.13|0.12|||ANCOVA|ANCOVA model, fitting fixed effect treatment term, and including baseline TBR value as a covariate.|The point estimate was calculated as least square mean difference (final values) of Losmapimod 7.5 mg once daily and Placebo.|Losmapimod 7.5 mg once daily versus Placebo||0.12|-0.13|0.9486
72560859|NCT04388787|144652283|SUPERIORITY|||||||0.03|||||||ANCOVA|||||||0.03
72560860|NCT04388787|144652284|SUPERIORITY|||||||0.0008|||||||ANCOVA|||||||0.0008
72619324|NCT00504556|144769251|SUPERIORITY_OR_OTHER|||||||0.023|TWO_SIDED||||||Fisher Exact|||Major bleeds||||0.023
72445949|NCT05093829|144407528|OTHER||Ratio of geometric mean titers|1511.1|||||TWO_SIDED|95.0|1169.5|1952.4|||||NmCV-5 divided by MenACWY-TT|For serogroup X, the point and interval estimates for the Geometric Mean Titer (GMT) ratio will be obtained from a back transformation (exponentiation) of the estimated mean ratio of the log-transformed rSBA titers. The GMT ratio of rSBA titers at Day 29 is calculated for the NmCV-5 arm relative to the MenACWY-TT arm.||1952.4|1169.5|
72445950|NCT05093829|144407528|OTHER||Ratio of geometric mean titers|767.3|||||TWO_SIDED|95.0|553.2|1064.4|||||NmCV-5 divided by MenACWY-TT|For serogroup X, the point and interval estimates for the Geometric Mean Titer (GMT) ratio will be obtained from a back transformation (exponentiation) of the estimated mean ratio of the log-transformed rSBA titers. The GMT ratio of rSBA titers at Day 29 is calculated for the NmCV-5 arm relative to the MenACWY-TT arm.||1064.4|553.2|
72445951|NCT05093829|144407530|OTHER||Ratio of geometric mean titers|2756.4|||||TWO_SIDED|95.0|1976.3|3844.5|||||Day 29 divided by Day 1|For serogroup A, the point and interval estimates for the Geometric Mean Fold Rise (GMFR) will be obtained from a back transformation (exponentiation) of the estimated mean ratio of the log-transformed rSBA titers. The GMFR from baseline to Day 29 of rSBA titers is calculated as Day 29 divided by Day 1.||3844.5|1976.3|
72445952|NCT05093829|144407530|OTHER||Ratio of geometric mean titers|2506.9|||||TWO_SIDED|95.0|1404.0|4476.1|||||Day 29 divided by Day 1|For serogroup A, the point and interval estimates for the Geometric Mean Fold Rise (GMFR) will be obtained from a back transformation (exponentiation) of the estimated mean ratio of the log-transformed rSBA titers. The GMFR from baseline to Day 29 of rSBA titers is calculated as Day 29 divided by Day 1.||4476.1|1404.0|
72445953|NCT05093829|144407530|OTHER||Ratio of geometric mean titers|1179.0|||||TWO_SIDED|95.0|709.8|1958.6|||||Day 29 divided by Day 1|For serogroup A, the point and interval estimates for the Geometric Mean Fold Rise (GMFR) will be obtained from a back transformation (exponentiation) of the estimated mean ratio of the log-transformed rSBA titers. The GMFR from baseline to Day 29 of rSBA titers is calculated as Day 29 divided by Day 1.||1958.6|709.8|
72619325|NCT03280615|144769262|SUPERIORITY|||||||0.257|||||||Fisher Exact|||A Fisher exact test was performed||||0.257
72619326|NCT03280615|144769263|SUPERIORITY|||||||0.231|||||||Fisher Exact|||A mixed linear regression model for repeated measures was performed to test if the outcome behaved differently in both treatment groups||||0.231
72619327|NCT03280615|144769264|SUPERIORITY|||||||0.043|||||||Mixed Models Analysis|||A mixed linear regression model for repeated measures was performed to test if the outcome behaved differently in both treatment groups||||0.043
72445954|NCT05093829|144407530|OTHER||Ratio of geometric mean titers|1096.2|||||TWO_SIDED|95.0|513.4|2340.6|||||Day 29 divided by Day 1|For serogroup A, the point and interval estimates for the Geometric Mean Fold Rise (GMFR) will be obtained from a back transformation (exponentiation) of the estimated mean ratio of the log-transformed rSBA titers. The GMFR from baseline to Day 29 of rSBA titers is calculated as Day 29 divided by Day 1.||2340.6|513.4|
72445955|NCT05093829|144407530|OTHER||Ratio of geometric mean titers|288.7|||||TWO_SIDED|95.0|212.6|392.0|||||Day 29 divided by Day 1|For serogroup C, the point and interval estimates for the Geometric Mean Fold Rise (GMFR) will be obtained from a back transformation (exponentiation) of the estimated mean ratio of the log-transformed rSBA titers. The GMFR from baseline to Day 29 of rSBA titers is calculated as Day 29 divided by Day 1.||392.0|212.6|
72445956|NCT05093829|144407530|OTHER||Ratio of geometric mean titers|654.5|||||TWO_SIDED|95.0|385.5|1111.0|||||Day 29 divided by Day 1|For serogroup C, the point and interval estimates for the Geometric Mean Fold Rise (GMFR) will be obtained from a back transformation (exponentiation) of the estimated mean ratio of the log-transformed rSBA titers. The GMFR from baseline to Day 29 of rSBA titers is calculated as Day 29 divided by Day 1.||1111.0|385.5|
72445957|NCT05093829|144407530|OTHER||Ratio of geometric mean titers|287.9|||||TWO_SIDED|95.0|213.9|387.5|||||Day 29 divided by Day 1|For serogroup C, the point and interval estimates for the Geometric Mean Fold Rise (GMFR) will be obtained from a back transformation (exponentiation) of the estimated mean ratio of the log-transformed rSBA titers. The GMFR from baseline to Day 29 of rSBA titers is calculated as Day 29 divided by Day 1.||387.5|213.9|
72445958|NCT05093829|144407530|OTHER||Ratio of geometric mean titers|834.6|||||TWO_SIDED|95.0|496.7|1402.3|||||Day 29 divided by Day 1|For serogroup C, the point and interval estimates for the Geometric Mean Fold Rise (GMFR) will be obtained from a back transformation (exponentiation) of the estimated mean ratio of the log-transformed rSBA titers. The GMFR from baseline to Day 29 of rSBA titers is calculated as Day 29 divided by Day 1.||1402.3|496.7|
72445959|NCT05093829|144407530|OTHER||Ratio of geometric mean titers|1068.4|||||TWO_SIDED|95.0|683.3|1670.6|||||Day 29 divided by Day 1|For serogroup W, the point and interval estimates for the Geometric Mean Fold Rise (GMFR) will be obtained from a back transformation (exponentiation) of the estimated mean ratio of the log-transformed rSBA titers. The GMFR from baseline to Day 29 of rSBA titers is calculated as Day 29 divided by Day 1.||1670.6|683.3|
72445960|NCT05093829|144407530|OTHER||Ratio of geometric mean titers|1933.1|||||TWO_SIDED|95.0|1224.7|3051.1|||||Day 29 divided by Day 1|For serogroup W, the point and interval estimates for the Geometric Mean Fold Rise (GMFR) will be obtained from a back transformation (exponentiation) of the estimated mean ratio of the log-transformed rSBA titers. The GMFR from baseline to Day 29 of rSBA titers is calculated as Day 29 divided by Day 1.||3051.1|1224.7|
72445961|NCT05093829|144407530|OTHER||Ratio of geometric mean titers|3163.1|||||TWO_SIDED|95.0|2247.5|4451.7|||||Day 29 divided by Day 1|For serogroup W, the point and interval estimates for the Geometric Mean Fold Rise (GMFR) will be obtained from a back transformation (exponentiation) of the estimated mean ratio of the log-transformed rSBA titers. The GMFR from baseline to Day 29 of rSBA titers is calculated as Day 29 divided by Day 1.||4451.7|2247.5|
72445962|NCT05093829|144407530|OTHER||Ratio of geometric mean titers|1524.1|||||TWO_SIDED|95.0|913.5|2543.0|||||Day 29 divided by Day 1|For serogroup W, the point and interval estimates for the Geometric Mean Fold Rise (GMFR) will be obtained from a back transformation (exponentiation) of the estimated mean ratio of the log-transformed rSBA titers. The GMFR from baseline to Day 29 of rSBA titers is calculated as Day 29 divided by Day 1.||2543.0|913.5|
72445963|NCT05093829|144407530|OTHER||Ratio of geometric mean titers|799.4|||||TWO_SIDED|95.0|532.9|1199.4|||||Day 29 divided by Day 1|For serogroup Y, the point and interval estimates for the Geometric Mean Fold Rise (GMFR) will be obtained from a back transformation (exponentiation) of the estimated mean ratio of the log-transformed rSBA titers. The GMFR from baseline to Day 29 of rSBA titers is calculated as Day 29 divided by Day 1.||1199.4|532.9|
72497680|NCT01412957|144525363|SUPERIORITY_OR_OTHER||Normal score|-5.98|||<|0.0001|||||||Log Rank|Log-rank test stratified by randomization factors: geographic region (Europe vs Asia vs rest of world) and ECOG performance status (0 or 1 vs 2).|A normal score \< 0 indicates fewer than expected events for the panitumumab plus BSC arm and therefore a longer time to event.|PFS in the Wild-type RAS Efficacy Analysis Set was to be compared at a significance level of 5% if overall survival in the wild-type RAS Efficacy Anaysis Set demonstrated a significant treatment effect.||||<0.0001
72497681|NCT01412957|144525364|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|24.89|||<|0.0001|TWO_SIDED|95.0|7.47|123.77|||Stratified exact test|Stratified by randomization factors: geographic region (Europe vs Asia vs rest of world) and ECOG performance status (0 or 1 vs 2).|The odds ratio is defined as the odds of having an objective response in the panitumumab plus BSC arm relative to the odds in BSC alone arm.|ORR was not formally tested and the p-values are descriptive only. An exact test was used to test the hypothesis that the common odds ratio for panitumumab plus BSC relative to BSC alone for the objective response is equal to 1.0 stratified by the randomization factors.||123.77|7.47|<0.0001
72497682|NCT01412957|144525365|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|20.0|||<|0.0001|TWO_SIDED|95.0|5.89|101.62|||Stratified exact test|Stratified by randomization factors: geographic region (Europe vs Asia vs rest of world) and ECOG performance status (0 or 1 vs 2).|The odds ratio is defined as the odds of having an objective response in the panitumumab plus BSC arm relative to the odds in BSC alone arm.|ORR was not formally tested and the p-values are descriptive only. An exact test was used to test the hypothesis that the common odds ratio for panitumumab plus BSC relative to BSC alone for the objective response is equal to 1.0 stratified by the randomization factors.||101.62|5.89|<0.0001
72497683|NCT04722991|144525374|OTHER|Bayesian inference with non-informative priors|Point estimate|-0.015|||||TWO_SIDED|95.0|-0.08|0.029|||||Median of posterior distribution|||0.029|-0.080|
72497684|NCT04343651|144525386|SUPERIORITY|||||||0.818|||||||ANCOVA|||||||0.818
72445964|NCT05093829|144407530|OTHER||Ratio of geometric mean titers|1469.2|||||TWO_SIDED|95.0|995.3|2168.8|||||Day 29 divided by Day 1|For serogroup Y, the point and interval estimates for the Geometric Mean Fold Rise (GMFR) will be obtained from a back transformation (exponentiation) of the estimated mean ratio of the log-transformed rSBA titers. The GMFR from baseline to Day 29 of rSBA titers is calculated as Day 29 divided by Day 1.||2168.8|995.3|
72497685|NCT04343651|144525387|SUPERIORITY||Hazard Ratio (HR)|0.781||||0.4138|TWO_SIDED|95.0|0.43|1.41|||Likelihood test-Cox Prop. hazards model|Stratification factors: Baseline NEWS Total score and Age.||||1.41|0.43|0.4138
72497686|NCT02246621|144525403|SUPERIORITY||Hazard Ratio (HR)|0.54||||2e-06|TWO_SIDED|95.0|0.418|0.698|||Log Rank|||||0.698|0.418|0.000002
72445965|NCT05093829|144407530|OTHER||Ratio of geometric mean titers|549.4|||||TWO_SIDED|95.0|371.8|811.8|||||Day 29 divided by Day 1|For serogroup Y, the point and interval estimates for the Geometric Mean Fold Rise (GMFR) will be obtained from a back transformation (exponentiation) of the estimated mean ratio of the log-transformed rSBA titers. The GMFR from baseline to Day 29 of rSBA titers is calculated as Day 29 divided by Day 1.||811.8|371.8|
72445966|NCT05093829|144407530|OTHER||Ratio of geometric mean titers|642.6|||||TWO_SIDED|95.0|309.2|1335.9|||||Day 29 divided by Day 1|For serogroup Y, the point and interval estimates for the Geometric Mean Fold Rise (GMFR) will be obtained from a back transformation (exponentiation) of the estimated mean ratio of the log-transformed rSBA titers. The GMFR from baseline to Day 29 of rSBA titers is calculated as Day 29 divided by Day 1.||1335.9|309.2|
72445967|NCT05093829|144407530|OTHER||Ratio of geometric mean titers|2630.0|||||TWO_SIDED|95.0|2037.6|3394.6|||||Day 29 divided by Day 1|For serogroup X, the point and interval estimates for the Geometric Mean Fold Rise (GMFR) will be obtained from a back transformation (exponentiation) of the estimated mean ratio of the log-transformed rSBA titers. The GMFR from baseline to Day 29 of rSBA titers is calculated as Day 29 divided by Day 1.||3394.6|2037.6|
72445968|NCT05093829|144407530|OTHER||Ratio of geometric mean titers|2.0|||||TWO_SIDED|95.0|1.2|3.4|||||Day 29 divided by Day 1|For serogroup X, the point and interval estimates for the Geometric Mean Fold Rise (GMFR) will be obtained from a back transformation (exponentiation) of the estimated mean ratio of the log-transformed rSBA titers. The GMFR from baseline to Day 29 of rSBA titers is calculated as Day 29 divided by Day 1.||3.4|1.2|
72445969|NCT05093829|144407530|OTHER||Ratio of geometric mean titers|1431.2|||||TWO_SIDED|95.0|905.2|2262.9|||||Day 29 divided by Day 1|For serogroup X, the point and interval estimates for the Geometric Mean Fold Rise (GMFR) will be obtained from a back transformation (exponentiation) of the estimated mean ratio of the log-transformed rSBA titers. The GMFR from baseline to Day 29 of rSBA titers is calculated as Day 29 divided by Day 1.||2262.9|905.2|
72445970|NCT05093829|144407530|OTHER||Ratio of geometric mean titers|1.7|||||TWO_SIDED|95.0|0.9|3.3|||||Day 29 divided by Day 1|For serogroup X, the point and interval estimates for the Geometric Mean Fold Rise (GMFR) will be obtained from a back transformation (exponentiation) of the estimated mean ratio of the log-transformed rSBA titers. The GMFR from baseline to Day 29 of rSBA titers is calculated as Day 29 divided by Day 1.||3.3|0.9|
72445971|NCT00667251|144407554|OTHER||Hazard Ratio (HR)|1.367||||0.001|TWO_SIDED|95.0|1.133|1.648|||Log Rank|||PFS at the time of Primary Analysis (IIT population)||1.648|1.133|0.0010
72497687|NCT02246621|144525405|SUPERIORITY|||||||0.005|||||||Cochran-Mantel-Haenszel|||||||0.005
72497688|NCT02246621|144525407|SUPERIORITY|||||||0.501|||||||Cochran-Mantel-Haenszel|||||||0.501
72497689|NCT02246621|144525408|SUPERIORITY|||||||0.101|||||||Cochran-Mantel-Haenszel|||||||0.101
72497690|NCT02246621|144525412|SUPERIORITY||Mean Difference (Net)|-0.01|STANDARD_ERROR_OF_MEAN|0.02||0.688|TWO_SIDED||||||Mixed Models Analysis|||||||0.688
72497691|NCT02246621|144525413|SUPERIORITY||Mean Difference (Net)|-1.01|STANDARD_ERROR_OF_MEAN|1.39||0.466|TWO_SIDED||||||Mixed Models Analysis|||||||0.466
72497692|NCT01475734|144525439|SUPERIORITY_OR_OTHER||Ratio|0.993||||0.791|TWO_SIDED|95.0|0.946|1.043|||ANOVA||The estimated value represents the ratio of geometric least squares means (albiglutide 50 mg) to placebo at 0 hr.|||1.043|0.946|0.791
72497693|NCT01475734|144525439|SUPERIORITY_OR_OTHER||Ratio|1.0|||>|0.999|TWO_SIDED|95.0|0.952|1.05|||ANOVA||The estimated value represents the ratio of geometric least squares means (albiglutide 50 mg) to placebo at 1 hr.|||1.050|0.952|>0.999
72497694|NCT01475734|144525439|SUPERIORITY_OR_OTHER||Ratio|1.001||||0.975|TWO_SIDED|95.0|0.953|1.051|||ANOVA||The estimated value represents the ratio of geometric least squares means (albiglutide 50 mg) to placebo at 1 hr 15 min.|||1.051|0.953|0.975
72497695|NCT01475734|144525439|SUPERIORITY_OR_OTHER||Ratio|1.0|||>|0.999|TWO_SIDED|95.0|0.952|1.05|||ANOVA||The estimated value represents the ratio of geometric least squares means (albiglutide 50 mg) to placebo at 1 hr 45 min.|||1.050|0.952|>0.999
72497696|NCT01475734|144525439|SUPERIORITY_OR_OTHER||Ratio|1.003||||0.908|TWO_SIDED|95.0|0.955|1.053|||ANOVA||The estimated value represents the ratio of geometric least squares means (albiglutide 50 mg) to placebo at 2 hr.|||1.053|0.955|0.908
72497697|NCT01475734|144525439|SUPERIORITY_OR_OTHER||Ratio|1.025||||0.312|TWO_SIDED|95.0|0.977|1.077|||ANOVA||The estimated value represents the ratio of geometric least squares means (albiglutide 50 mg) to placebo at 2 hr 45 min.|||1.077|0.977|0.312
72497698|NCT01475734|144525439|SUPERIORITY_OR_OTHER||Ratio|1.008||||0.763|TWO_SIDED|95.0|0.96|1.058|||ANOVA||The estimated value represents the ratio of geometric least squares means (albiglutide 50 mg) to placebo at 3 hr.|||1.058|0.960|0.763
72497699|NCT01475734|144525439|SUPERIORITY_OR_OTHER||Ratio|1.095|||<|0.001|TWO_SIDED|95.0|1.043|1.15|||ANOVA||The estimated value represents the ratio of geometric least squares means (albiglutide 50 mg) to placebo at 3 hr 30 min.|||1.150|1.043|<0.001
72497700|NCT01475734|144525439|SUPERIORITY_OR_OTHER||Ratio|1.046||||0.07|TWO_SIDED|95.0|0.996|1.098|||ANOVA||The estimated value represents the ratio of geometric least squares means (albiglutide 50 mg) to placebo at 3 hr 45 min.|||1.098|0.996|0.070
72497701|NCT01475734|144525439|SUPERIORITY_OR_OTHER||Ratio|0.971||||0.238|TWO_SIDED|95.0|0.925|1.02|||ANOVA||The estimated value represents the ratio of geometric least squares means (albiglutide 50 mg) to placebo at 4 hr 15 min.|||1.020|0.925|0.238
72497702|NCT01475734|144525439|SUPERIORITY_OR_OTHER||Ratio|0.975||||0.298|TWO_SIDED|95.0|0.928|1.023|||ANOVA||The estimated value represents the ratio of geometric least squares means (albiglutide 50 mg) to placebo at 4 hr 30 min.|||1.023|0.928|0.298
72445972|NCT00667251|144407554|OTHER||Hazard Ratio (HR)|1.484||||0.0002|TWO_SIDED|95.0|1.204|1.829|||Log Rank|||PFS at the time of Primary Analysis (Central HER2+ population)||1.829|1.204|0.0002
72445973|NCT00667251|144407555|OTHER||Hazard Ratio (HR)|1.3722|||||TWO_SIDED|95.0|1.1466|1.6422|||||Stratified HR for LTax/L versus TTax/T|PFS at the time of Final Analysis (IIT population)||1.6422|1.1466|
72445974|NCT00667251|144407555|OTHER||Hazard Ratio (HR)|1.4968|||||TWO_SIDED|95.0|1.2251|1.8288|||||Stratified HR for LTax/L versus TTax/T|PFS at the time of Final Analysis (Central HER2+ population)||1.8288|1.2251|
72445975|NCT00667251|144407556|OTHER||Hazard Ratio (HR)|1.3786|||||TWO_SIDED|95.0|1.0246|1.8549|||||Stratified HR for LTax/L versus TTax/T|Overall Survival (OS) (IIT population)||1.8549|1.0246|
72445976|NCT00667251|144407557|OTHER||Hazard Ratio (HR)|1.5818|||||TWO_SIDED|95.0|1.1181|2.2379|||||Stratified HR for LTax/L versus TTax/T|Overall Survival (OS) (Central HER2+ population)||2.2379|1.1181|
72445977|NCT00667251|144407560|OTHER||Hazard Ratio (HR)|1.0916|||||TWO_SIDED|95.0|0.7271|1.6389|||||Stratified HR for LTax/L versus TTax/T|Time to Central Nervous System (CNS) metastasis (IIT population)||1.6389|0.7271|
72445978|NCT00667251|144407561|OTHER||Hazard Ratio (HR)|1.0951|||||TWO_SIDED|95.0|0.7144|1.6787|||||Stratified HR for LTax/L versus TTax/T|Time to Central Nervous System (CNS) metastasis (Central HER2+ population)||1.6787|0.7144|
72445979|NCT00667251|144407566|OTHER||Hazard Ratio (HR)|1.0091|||||TWO_SIDED|95.0|0.809|1.2586|||||Stratified HR for LTax/L versus TTax/T|Time to Response (TTR) (IIT population)||1.2586|0.8090|
72445980|NCT00667251|144407567|OTHER||Hazard Ratio (HR)|0.9573|||||TWO_SIDED|95.0|0.7544|1.2148|||||Stratified HR for LTax/L versus TTax/T|Time to Response (TTR) (Central HER2+ population)||1.2148|0.7544|
72445981|NCT00667251|144407568|OTHER||Hazard Ratio (HR)|1.4866|||||TWO_SIDED|95.0|1.1479|1.9251|||||Stratified HR for LTax/L versus TTax/T|Duration of Response (DoR) (IIT population)||1.9251|1.1479|
72445982|NCT00667251|144407569|OTHER||Hazard Ratio (HR)|1.5594|||||TWO_SIDED|95.0|1.1767|2.0666|||||Stratified HR for LTax/L versus TTax/T|Duration of Response (DoR) (Central HER2+ population)||2.0666|1.1767|
72445983|NCT04318548|144407638|NON_INFERIORITY|NI was to be demonstrated if the lower limit (LL) of the 2-sided 95% CI of the GMT ratio between the MenB+MenACWY group and MenB group for hSBA titers against M14459 (fHbp) strain was above (\>) 0.5|GMT Ratio|0.9|||||TWO_SIDED|95.0|0.77|1.06|||ANOVA||The ratio of GMTs (MenB+MenACWY/MenB) and the corresponding CI is constructed by exponentiating the mean difference and the confidence limits in log10 (titer), using ANOVA with study centre included as an independent variable.|To demonstrate the non-inferiority (NI) of the antibody response to rMenB+OMV NZ given concomitantly with MenACWY compared to rMenB+OMV NZ administered alone, measured by hSBA GMTs against N. meningitidis serogroup B indicator strains at one month after the second vaccination with rMenB+OMV NZ (at Day 91).||1.06|0.77|
72445984|NCT04318548|144407638|NON_INFERIORITY|NI was to be demonstrated if LL of the 2-sided 95% CI of the GMT ratio between the MenB+MenACWY group and MenB group for hSBA titers against 96217 (NadA) strain was \>0.5|GMT Ratio|0.88|||||TWO_SIDED|95.0|0.75|1.04|||ANOVA||The ratio of GMTs (MenB+MenACWY/MenB) and the corresponding CI is constructed by exponentiating the mean difference and the confidence limits in log10 (titer), using ANOVA with study centre included as an independent variable.|To demonstrate the non-inferiority of the antibody response to rMenB+OMV NZ given concomitantly with MenACWY compared to rMenB+OMV NZ administered alone, measured by hSBA GMTs against N. meningitidis serogroup B indicator strains at one month after the second vaccination with rMenB+OMV NZ (at Day 91).||1.04|0.75|
72445985|NCT04318548|144407638|NON_INFERIORITY|NI was to be demonstrated if LL of the 2-sided 95% CI of the GMT ratio between the MenB+MenACWY group and MenB group for hSBA titers against NZ98/254 (PorA) strain was \>0.5.|GMT Ratio|0.93|||||TWO_SIDED|95.0|0.76|1.12|||ANOVA||The ratio of GMTs (MenB+MenACWY/MenB) and the corresponding CI is constructed by exponentiating the mean difference and the confidence limits in log10 (titer), using ANOVA with study centre included as an independent variable.|To demonstrate the non-inferiority of the antibody response to rMenB+OMV NZ given concomitantly with MenACWY compared to rMenB+OMV NZ administered alone, measured by hSBA GMTs against N. meningitidis serogroup B indicator strains at one month after the second vaccination with rMenB+OMV NZ (at Day 91).||1.12|0.76|
72445986|NCT04318548|144407638|NON_INFERIORITY|NI was to be demonstrated if LL of the 2-sided 95% CI of the GMT ratio between the MenB+MenACWY group and MenB group for hSBA titers against M13520 (NHBA) strain was \>0.5|GMT Ratio|0.88|||||TWO_SIDED|95.0|0.73|1.06|||ANOVA||The ratio of GMTs (MenB+MenACWY/MenB) and the corresponding CI is constructed by exponentiating the mean difference and the confidence limits in log10 (titer), using ANOVA with study centre included as an independent variable.|To demonstrate the non-inferiority of the antibody response to rMenB+OMV NZ given concomitantly with MenACWY compared to rMenB+OMV NZ administered alone, measured by hSBA GMTs against N. meningitidis serogroup B indicator strains at one month after the second vaccination with rMenB+OMV NZ (at Day 91).||1.06|0.73|
72445987|NCT04318548|144407639|NON_INFERIORITY|NI was to be demonstrated if LL of the 2-sided 95% CI of the between-group ratio of hSBA GMTs between MenB+MenACWY group and MenACWY group for Men A serogroup was \>0.5.|GMT Ratio|0.94|||||TWO_SIDED|95.0|0.78|1.14|||ANOVA||The ratio of GMTs (MenB+MenACWY/MenACWY) and the corresponding CI is constructed by exponentiating the mean difference and the confidence limits in log10 (titer), using ANOVA with study centre included as an independent variable.|To demonstrate the non-inferiority of the antibody response to MenACWY given concomitantly with rMenB+OMV NZ compared to MenACWY administered alone, as measured by hSBA GMTs against the N. meningitidis serogroup Men A, at one month after the vaccination with MenACWY (at Day 31).||1.14|0.78|
72445988|NCT04318548|144407639|NON_INFERIORITY|NI was to be demonstrated if LL of the 2-sided 95% CI of the between-group ratio of hSBA GMTs between MenB+MenACWY group and MenACWY group for Men C serogroup was \>0.5.|GMT Ratio|1.11|||||TWO_SIDED|95.0|0.86|1.44|||ANOVA||The ratio of GMTs (MenB+MenACWY/MenACWY) and the corresponding CI is constructed by exponentiating the mean difference and the confidence limits in log10 (titer), using ANOVA with study centre included as an independent variable.|To demonstrate the non-inferiority of the antibody response to MenACWY given concomitantly with rMenB+OMV NZ compared to MenACWY administered alone, as measured by hSBA GMTs against the N. meningitidis serogroup Men C, at one month after the vaccination with MenACWY (at Day 31).||1.44|0.86|
72445989|NCT04318548|144407639|NON_INFERIORITY|NI was to be demonstrated if LL of the 2-sided 95% CI of the between-group ratio of hSBA GMTs between MenB+MenACWY group and MenACWY group for Men W serogroup was \>0.5.|GMT Ratio|1.0|||||TWO_SIDED|95.0|0.82|1.21|||ANOVA||The ratio of GMTs (MenB+MenACWY/MenACWY) and the corresponding CI is constructed by exponentiating the mean difference and the confidence limits in log10 (titer), using ANOVA with study centre included as an independent variable.|To demonstrate the non-inferiority of the antibody response to MenACWY given concomitantly with rMenB+OMV NZ compared to MenACWY administered alone, as measured by hSBA GMTs against the N. meningitidis serogroup Men W, at one month after the vaccination with MenACWY (at Day 31).||1.21|0.82|
72497703|NCT01475734|144525439|SUPERIORITY_OR_OTHER||Ratio|0.994||||0.821|TWO_SIDED|95.0|0.947|1.044|||ANOVA||The estimated value represents the ratio of geometric least squares means (albiglutide 50 mg) to placebo at 4 hr 45 min.|||1.044|0.947|0.821
72497704|NCT01475734|144525439|SUPERIORITY_OR_OTHER||Ratio|0.991||||0.715|TWO_SIDED|95.0|0.944|1.04|||ANOVA||The estimated value represents the ratio of geometric least squares means (albiglutide 50 mg) to placebo at 5 hr.|||1.040|0.944|0.715
72497705|NCT01475734|144525439|SUPERIORITY_OR_OTHER||Ratio|1.008||||0.759|TWO_SIDED|95.0|0.96|1.058|||ANOVA||The estimated value represents the ratio of geometric least squares means (albiglutide 50 mg) to placebo at 5 hr 15 min.|||1.058|0.960|0.759
72389769|NCT03130257|144287488|EQUIVALENCE|The study planned for a sample size of 510 and 80% protocol completion, resulting in sample size 136 per group. With this sample size, the least detectable difference (LDD) is 4.1 mmHg systolic BP (SBP) and 2.8 mmHg diastolic BP (DBP) between any two groups (assuming Standard Deviation 12.1 and 8.3 for SBP and DBP respectively). Actual sample sizes completing protocol were 142, 149, and 111 for Clinic, Home, and Kiosk groups respectively, resulting in LDD of at least 4.3 for SBP and 3.0 for DBP.|||||<|0.05|||||||Regression, Linear|||We used linear regression models to estimate the mean difference in BP between diagnostic measurement and daytime average 24-hr BP for each randomization group. Models were estimated using generalized estimating equations with robust standard errors, and adjusted for age, sex, BMI, education, and baseline systolic and diastolic BP. Separate models estimated mean differences (diagnostic protocol - 24-hr BP) between groups for systolic and diastolic BP.||||<0.05
72389770|NCT01847274|144287489|SUPERIORITY||Hazard Ratio (HR)|0.27|||<|0.0001|TWO_SIDED|95.0|0.173|0.41||Two-sided P-value. PFS was independently evaluated in gBRCAmut cohort and non-gBRCAmut cohort.|Log Rank|Strata: tm to progression after penultimate platinum tx; use of bevacizumab w/penultimate or last platinum tx; best response during last platinum tx.|Niraparib:Placebo, based on the stratified Cox Proportional Hazards Model using randomization stratification factors.|||0.410|0.173|<0.0001
72389771|NCT01847274|144287490|SUPERIORITY||Hazard Ratio (HR)|0.38|||<|0.0001|TWO_SIDED|95.0|0.243|0.586||Two-sided P-value. PFS was independently evaluated in gBRCAmut cohort and non-gBRCAmut cohort. Hierarchical testing: HRD+ subset tested first. If HRD+ subset demonstrated statistical significance, overall non-gBRCA cohort was then tested|Log Rank|Strata: tm to progression after penultimate platinum tx; use of bevacizumab w/penultimate or last platinum tx; best response during last platinum tx.|Niraparib:Placebo, based on the stratified Cox Proportional Hazards Model using randomization stratification factors.|||0.586|0.243|<0.0001
72389772|NCT01847274|144287491|SUPERIORITY||Hazard Ratio (HR)|0.45|||<|0.0001|TWO_SIDED|95.0|0.338|0.607||Two-sided P-value. PFS was independently evaluated in gBRCAmut cohort and non-gBRCAmut cohort. Hierarchical testing: HRD+ subset tested first. If HRD+ subset demonstrated statistical significance, overall non-gBRCA cohort was then tested.|Log Rank|Strata: tm to progression after penultimate platinum tx; use of bevacizumab w/penultimate or last platinum tx; best response during last platinum tx.|Niraparib:Placebo, based on the stratified Cox Proportional Hazards Model using randomization stratification factors.|||0.607|0.338|<0.0001
72389773|NCT01847274|144287492|SUPERIORITY||Hazard Ratio (HR)|0.57||||0.0005|TWO_SIDED|95.0|0.412|0.783||Two-sided p-value|Log Rank|||||0.783|0.412|0.0005
72389774|NCT01847274|144287493|SUPERIORITY||Hazard Ratio (HR)|0.58|||<|0.0001|TWO_SIDED|95.0|0.454|0.74||Two-sided P-value.|Log Rank|||||0.740|0.454|<0.0001
72389775|NCT01847274|144287494|SUPERIORITY||Hazard Ratio (HR)|0.39|||<|0.0001|TWO_SIDED|95.0|0.268|0.561||Two-sided P-value.|Log Rank|||||0.561|0.268|<0.0001
72389776|NCT01847274|144287495|SUPERIORITY||Hazard Ratio (HR)|0.56|||<|0.0001|TWO_SIDED|95.0|0.428|0.727||Two-sided P-value.|Log Rank|||||0.727|0.428|<0.0001
72389777|NCT01847274|144287496|SUPERIORITY||Hazard Ratio (HR)|0.7||||0.0302|TWO_SIDED|95.0|0.5|0.968||Two-sided P-value.|Log Rank|||||0.968|0.500|0.0302
72389778|NCT01847274|144287497|SUPERIORITY||Hazard Ratio (HR)|0.8||||0.0748|TWO_SIDED|95.0|0.627|1.022||Two-sided P-value.|Log Rank|||||1.022|0.627|0.0748
72389779|NCT01847274|144287498|SUPERIORITY||Hazard Ratio (HR)|0.85||||0.358|TWO_SIDED|95.0|0.606|1.198||Two-sided P-value.|Log Rank|||||1.198|0.606|0.3580
72389780|NCT01847274|144287499|SUPERIORITY||Hazard Ratio (HR)|1.06||||0.6868|TWO_SIDED|95.0|0.813|1.369||Two-sided P-value.|Log Rank|||||1.369|0.813|0.6868
72389781|NCT01847274|144287500|SUPERIORITY||Hazard Ratio (HR)|0.63||||0.0061|TWO_SIDED|95.0|0.451|0.878||Two-sided P-value.|Log Rank|||||0.878|0.451|0.0061
72389782|NCT01847274|144287501|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.1674|TWO_SIDED|95.0|0.654|1.077||Two-sided P-value.|Log Rank|||||1.077|0.654|0.1674
72389783|NCT01847274|144287518|SUPERIORITY|||||||0.7969|||||||Pearson's Chi-squared test|Analysis for gBRCA Niraparib vs gBRCA Placebo-Feet||||||0.7969
72389784|NCT01847274|144287518|SUPERIORITY|||||||0.8794|||||||Pearson's Chi-squared test|Analysis for gBRCA Niraparib vs gBRCA Placebo-Hands||||||0.8794
72389785|NCT01847274|144287519|SUPERIORITY|||||||0.2399|||||||Pearson's Chi-squared test|Analysis for gBRCA Niraparib vs gBRCA Placebo-Feet||||||0.2399
72389786|NCT01847274|144287519|SUPERIORITY|||||||0.4584|||||||Pearson's Chi-squared test|Analysis for gBRCA Niraparib vs gBRCA Placebo-Hands||||||0.4584
72389787|NCT01847274|144287520|SUPERIORITY|||||||0.8566|||||||Pearson's Chi-squared test|Analysis for gBRCA Niraparib vs gBRCA Placebo-Feet||||||0.8566
72389788|NCT01847274|144287520|SUPERIORITY|||||||0.4705|||||||Pearson's Chi-squared test|Analysis for gBRCA Niraparib vs gBRCA Placebo-Hands||||||0.4705
72389789|NCT01847274|144287521|SUPERIORITY|||||||0.8521|||||||Pearson's Chi-squared test|Analysis for gBRCA Niraparib vs gBRCA Placebo-Feet||||||0.8521
72389790|NCT01847274|144287521|SUPERIORITY|||||||0.9923|||||||Pearson's Chi-squared test|Analysis for gBRCA Niraparib vs gBRCA Placebo-Hands||||||0.9923
72389791|NCT01847274|144287522|SUPERIORITY|||||||0.9997|||||||Pearson's Chi-squared test|Analysis for gBRCA Niraparib vs gBRCA Placebo-Feet||||||0.9997
72389792|NCT01847274|144287522|SUPERIORITY|||||||0.3518|||||||Pearson's Chi-squared test|Analysis for gBRCA Niraparib vs gBRCA Placebo-Hands||||||0.3518
72389793|NCT01847274|144287523|SUPERIORITY|||||||0.9367|||||||Pearson's Chi-squared test|Analysis for gBRCA Niraparib vs gBRCA Placebo-Hands||||||0.9367
72389794|NCT01847274|144287523|SUPERIORITY|||||||0.2502|||||||Pearson's Chi-squared test|Analysis for gBRCA Niraparib vs gBRCA Placebo-Hands||||||0.2502
72389795|NCT01847274|144287524|SUPERIORITY|||||||0.5037|||||||Pearson's Chi-squared test|Analysis for gBRCA Niraparib vs gBRCA Placebo-Feet||||||0.5037
72389796|NCT01847274|144287524|SUPERIORITY|||||||0.164|||||||Pearson's Chi-squared test|Analysis for gBRCA Niraparib vs gBRCA Placebo-Hands||||||0.1640
72389797|NCT01847274|144287525|SUPERIORITY|||||||0.9599|||||||Pearson's Chi-squared test|Analysis for gBRCA Niraparib vs gBRCA Placebo-Feet||||||0.9599
72389798|NCT01847274|144287525|SUPERIORITY|||||||0.247|||||||Pearson's Chi-squared test|Analysis for gBRCA Niraparib vs gBRCA Placebo-Hands||||||0.2470
72389799|NCT01847274|144287526|SUPERIORITY|||||||0.5921|||||||Pearson's Chi-squared test|Analysis for gBRCA Niraparib vs gBRCA Placebo-Feet||||||0.5921
72389800|NCT01847274|144287526|SUPERIORITY|||||||0.7459|||||||Pearson's Chi-squared test|Analysis for gBRCA Niraparib vs gBRCA Placebo-Hands||||||0.7459
72497706|NCT01475734|144525439|SUPERIORITY_OR_OTHER||Ratio|1.0|||>|0.999|TWO_SIDED|95.0|0.952|1.05|||ANOVA||The estimated value represents the ratio of geometric least squares means (albiglutide 50 mg) to placebo at 5 hr 30 min.|||1.050|0.952|>0.999
72497707|NCT02265913|144525450|EQUIVALENCE|provides 85% of success|Equivalence ratio|98.0|||||TWO_SIDED|90.0|92.0|105.0|||Fieller's method|||||105|92|
72445990|NCT04318548|144407639|NON_INFERIORITY|NI was to be demonstrated if LL of the 2-sided 95% CI of the between-group ratio of hSBA GMTs between MenB+MenACWY group and MenACWY group for Men Y serogroup was \>0.5.|GMT Ratio|1.03|||||TWO_SIDED|95.0|0.84|1.27|||ANOVA||The ratio of GMTs (MenB+MenACWY/MenACWY) and the corresponding CI is constructed by exponentiating the mean difference and the confidence limits in log10 (titer), using ANOVA with study centre included as an independent variable.|To demonstrate the non-inferiority of the antibody response to MenACWY given concomitantly with rMenB+OMV NZ compared to MenACWY administered alone, as measured by hSBA GMTs against the N. meningitidis serogroup Men Y, at one month after the vaccination with MenACWY (at Day 31).||1.27|0.84|
72445991|NCT04318548|144407641|OTHER||GMT Ratio|0.76|||||TWO_SIDED|95.0|0.64|0.91|||ANOVA||The ratio of GMTs (MenB+MenACWY/MenB) and the corresponding CI is constructed by exponentiating the mean difference and the confidence limits in log10 (titer), using ANOVA with study centre included as an independent variable.|To assess the immune response to rMenB+OMV NZ given concomitantly with MenACWY compared to rMenB+OMV NZ administered alone, measured by hSBA GMTs against N. meningitidis M14459 (fHbp) strain at one month after the fisrt vaccination with rMenB+OMV NZ (at Day 31).||0.91|0.64|
72445992|NCT04318548|144407641|OTHER||GMT Ratio|0.62|||||TWO_SIDED|95.0|0.49|0.77|||ANOVA||The ratio of GMTs (MenB+MenACWY/MenB) and the corresponding CI is constructed by exponentiating the mean difference and the confidence limits in log10 (titer), using ANOVA with study centre included as an independent variable.|To assess the immune response to rMenB+OMV NZ given concomitantly with MenACWY compared to rMenB+OMV NZ administered alone, measured by hSBA GMTs against N. meningitidis 96217 (NadA) strain at one month after the first vaccination with rMenB+OMV NZ (at Day 31).||0.77|0.49|
72445993|NCT04318548|144407641|OTHER||GMT Ratio|0.73|||||TWO_SIDED|95.0|0.58|0.91|||ANOVA||The ratio of GMTs (MenB+MenACWY/MenB) and the corresponding CI is constructed by exponentiating the mean difference and the confidence limits in log10 (titer), using ANOVA with study centre included as an independent variable.|To assess the immune response to rMenB+OMV NZ given concomitantly with MenACWY compared to rMenB+OMV NZ administered alone, measured by hSBA GMTs against N. meningitidis NZ98/254 (PorA) strain at one month after the first vaccination with rMenB+OMV NZ (at Day 31).||0.91|0.58|
72445994|NCT04318548|144407641|OTHER||GMT Ratio|0.76|||||TWO_SIDED|95.0|0.64|0.9|||ANOVA||The ratio of GMTs (MenB+MenACWY/MenB) and the corresponding CI is constructed by exponentiating the mean difference and the confidence limits in log10 (titer), using ANOVA with study centre included as an independent variable.|To assess the immune response to rMenB+OMV NZ given concomitantly with MenACWY compared to rMenB+OMV NZ administered alone, measured by hSBA GMTs against N. meningitidis M13520 (NHBA) at one month after the first vaccination with rMenB+OMV NZ (at Day 31).||0.90|0.64|
72497708|NCT02107703|144525471|OTHER||Hazard Ratio (HR)|0.553|||<|1e-07|TWO_SIDED|95.0|0.449|0.681||This is two sided P value and it is statistically significant.|Log Rank|Log rank test is stratified by endocrine sensitivity and natural of disease by interactive web response system (IWRS).||The final analysis was planned at 378 PFS events, which would provide approximately 90% power assuming a hazard ratio (HR) of 0.703 at a one-sided α of 0.025.||0.681|0.449|<0.0000001
72497709|NCT00066690|144525517|SUPERIORITY||Hazard Ratio (HR)|0.83||||0.1|TWO_SIDED|95.0|0.66|1.04|||Log Rank||Tamoxifen was the reference group in the estimation of the hazard ratio.|||1.04|0.66|0.1
72497710|NCT00066690|144525517|SUPERIORITY||Hazard Ratio (HR)|0.68|||||TWO_SIDED|95.0|0.53|0.86|||||Tamoxifen was the reference group in the estimation of the hazard ratio.|||0.86|0.53|
72497711|NCT00066690|144525518|SUPERIORITY||Hazard Ratio (HR)|0.81||||0.09|TWO_SIDED|95.0|0.3|1.03|||Log Rank||Tamoxifen was the reference group in the estimation of the hazard ratio.|||1.03|0.3|0.09
72497712|NCT00066690|144525518|SUPERIORITY||Hazard Ratio (HR)|0.64|||||TWO_SIDED|95.0|0.49|0.83|||||Tamoxifen was the reference group in the estimation of the hazard ratio.|||0.83|0.49|
72497713|NCT00066690|144525519|SUPERIORITY||Hazard Ratio (HR)|0.88||||0.4|TWO_SIDED|95.0|0.66|1.18|||Log Rank||T was the reference group in the estimation of the hazard ratio.|||1.18|0.66|0.40
72497714|NCT00066690|144525519|SUPERIORITY||Hazard Ratio (HR)|0.71|||||TWO_SIDED|95.0|0.52|0.96|||||T was the reference group in the estimation of hazard ratio.|||0.96|0.52|
72497715|NCT00066690|144525520|SUPERIORITY|\[not specified\]|Hazard Ratio (HR)|0.67||||0.01|TWO_SIDED|95.0|0.48|0.92|||Log Rank||T was the reference group in the estimation of the hazard ratio|||0.92|0.48|0.01
72497716|NCT00066690|144525520|SUPERIORITY|\[not specified\]|Hazard Ratio (HR)|0.85|||||TWO_SIDED|95.0|0.62|1.15|||||T was the reference group in the estimation of hazard ratio|||1.15|0.62|
72497717|NCT05256888|144525522|SUPERIORITY||Slope|-1.77|STANDARD_ERROR_OF_MEAN|1.08||0.11|TWO_SIDED||||||Regression, Linear|||"In a linear model to assess group effects on fatigue at 12 weeks, adjusting for baseline levels of fatigue:~Effect of group = -1.77±1.08, p=0.11, favoring the TRE group."||||0.11
72497718|NCT03706365|144525526|OTHER||Hazard Ratio (HR)|0.829||||0.2123|TWO_SIDED|95.0|0.619|1.111|||Log Rank|||||1.111|0.619|0.2123
72497719|NCT03706365|144525527|OTHER||Hazard Ratio (HR)|0.637||||0.0026|TWO_SIDED|95.0|0.474|0.856|||Log Rank|||||0.856|0.474|0.0026
72497720|NCT03706365|144525528|OTHER||Hazard Ratio (HR)|0.842||||0.2899|TWO_SIDED|95.0|0.611|1.16|||Log Rank|||||1.160|0.611|0.2899
72497721|NCT03706365|144525530|OTHER||Hazard Ratio (HR)|0.731||||0.3531|TWO_SIDED|95.0|0.377|1.419|||Log Rank|||||1.419|0.377|0.3531
72497722|NCT03706365|144525531|OTHER||Hazard Ratio (HR)|0.927||||0.6507|TWO_SIDED|95.0|0.669|1.285|||Log Rank|||||1.285|0.669|0.6507
72497723|NCT03706365|144525532|OTHER||Hazard Ratio (HR)|0.768||||0.1807|TWO_SIDED|95.0|0.522|1.131|||Log Rank|||||1.131|0.522|0.1807
72497724|NCT03706365|144525537|OTHER||Hazard Ratio (HR)|0.935||||0.697|TWO_SIDED|95.0|0.665|1.314|||Log Rank|||||1.314|0.665|0.6970
72497725|NCT03116113|144525540|SUPERIORITY||||||=|0.3181|||||||Fisher's Exact-Boschloo test|||||||=0.3181
72497726|NCT03116113|144525540|SUPERIORITY||||||=|0.5177|||||||Fisher's Exact-Boschloo test|||||||=0.5177
72445995|NCT05178316|144407720|SUPERIORITY||Least squares mean difference|0.31|STANDARD_ERROR_OF_MEAN|2.175|=|0.8862|TWO_SIDED|95.0|-3.98|4.6|||Mixed Models Analysis|||||4.60|-3.98|=0.8862
72445996|NCT05178316|144407720|SUPERIORITY||Least squares mean difference|-0.74|STANDARD_ERROR_OF_MEAN|1.817|=|0.6832|TWO_SIDED|95.0|-4.32|2.84|||Mixed Models Analysis|||||2.84|-4.32|=0.6832
72445997|NCT05178316|144407721|SUPERIORITY||Least squares mean difference|-0.15|STANDARD_ERROR_OF_MEAN|0.204|=|0.4522|TWO_SIDED|95.0|-0.55|0.25|||Mixed Models Analysis|||||0.25|-0.55|=0.4522
72445998|NCT05178316|144407721|SUPERIORITY||Least squares mean difference|-0.22|STANDARD_ERROR_OF_MEAN|0.169|=|0.2032|TWO_SIDED|95.0|-0.55|0.12|||Mixed Models Analysis|||||0.12|-0.55|=0.2032
72445999|NCT05178316|144407722|SUPERIORITY||Least squares mean difference|-0.06|STANDARD_ERROR_OF_MEAN|0.165|=|0.717|TWO_SIDED|95.0|-0.38|0.26|||Mixed Models Analysis|||||0.26|-0.38|=0.7170
72446000|NCT05178316|144407722|SUPERIORITY||Least squares mean difference|-0.16|STANDARD_ERROR_OF_MEAN|0.137|=|0.2423|TWO_SIDED|95.0|-0.43|0.11|||Mixed Models Analysis|||||0.11|-0.43|=0.2423
72446001|NCT03457142|144407724|OTHER|No formal test, a confidence interval estimate for the grade 3+ treatment related AE rate.|grade 3+ treatment related AE rate|0.33|||||TWO_SIDED|90.0|0.17|0.54||||||||0.54|0.17|
72446002|NCT01748448|144407729|SUPERIORITY||Cox Proportional Hazard|1.27|||=|0.324|TWO_SIDED|95.0|0.79|2.03|||Fisher Exact|||||2.03|0.79|= 0.324
72446003|NCT02907099|144407736|OTHER|||||||0.5|||||||t-test, 2 sided|||||||0.5
72446004|NCT02907099|144407737|OTHER|||||||0.5|||||||t-test, 2 sided|||||||0.5
72446005|NCT04274764|144407739|OTHER|||||||0.7399|||||||Chi-squared|||||||0.7399
72446006|NCT02677298|144407740|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
72497727|NCT05195528|144525597|SUPERIORITY||Difference in least square mean|17.1|||<|0.0001|TWO_SIDED|95.0|11.81|22.45||P-values were obtained from the general linear model with treatment group as factor and severity and frequency of heartburn at baseline as covariates.|General linear model|||||22.45|11.81|<0.0001
72497728|NCT05195528|144525597|SUPERIORITY||Least square mean difference|16.7|||<|0.0001|TWO_SIDED|95.0|11.36|22.04||P-values were obtained from the general linear model with treatment group as factor and severity and frequency of heartburn at baseline as covariates.|General linear model|||||22.04|11.36|<0.0001
72560861|NCT00688844|144652285|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.655574|STANDARD_DEVIATION|8.060658||0.692782|||||||t-test, 2 sided|||Objective was to evaluate BMI across one year in PKU patients introduced to sapropterin after baseline. Study was prospective cohort in design.||||0.692782
72497729|NCT05195528|144525598|SUPERIORITY||Least square mean difference|15.8|||<|0.0001|TWO_SIDED|95.0|9.93|21.6||P-values were obtained from the general linear model with treatment group as factor and severity and frequency of heartburn at baseline as covariates.|General linear model|||||21.60|9.93|<0.0001
72446007|NCT02677298|144407741|SUPERIORITY||||||<|0.001||||||For the testing a hierarchical approach has been applied. The result of this test is considered confirmative if the test of the Primary Outcome Measure shows a confirmatory result at a one-sided significance level of 0.025.|Cochran-Mantel-Haenszel|||||||<0.001
72497730|NCT05195528|144525598|SUPERIORITY||Least square mean difference|13.7|||<|0.0001|TWO_SIDED|95.0|7.84|19.54||P-values were obtained from the general linear model with treatment group as factor and severity and frequency of heartburn at baseline as covariates.|General linear model|||||19.54|7.84|<0.0001
72446008|NCT02677298|144407742|SUPERIORITY|||||||0.003||||||For the testing a hierarchical approach has been applied. The result of this test is considered confirmative if the test of the Primary and all previous Secondary Outcome Measures show a confirmatory result at a one-sided significance level of 0.025.|Cochran-Mantel-Haenszel|||||||0.003
72446009|NCT02677298|144407743|SUPERIORITY||||||<|0.001||||||For the testing a hierarchical approach has been applied. The result of this test is considered confirmative if the test of the Primary and all previous Secondary Outcome Measures show a confirmatory result at a one-sided significance level of 0.025.|Cochran-Mantel-Haenszel|||Test performed for Investigator's In-clinic Assessment||||<0.001
72446010|NCT02677298|144407743|SUPERIORITY||||||<|0.001||||||For the testing a hierarchical approach has been applied. The result of this test is considered confirmative if the test of the Primary and all previous Secondary Outcome Measures show a confirmatory result at a one-sided significance level of 0.025.|Cochran-Mantel-Haenszel|||Test performed for Subject's In-clinic Assessment||||<0.001
72446011|NCT02677298|144407744|SUPERIORITY|||||||0.084||||||For the testing a hierarchical approach has been applied. The result of this test is considered confirmative if the test of the Primary and all previous Secondary Outcome Measures show a confirmatory result at a one-sided significance level of 0.025.|Cochran-Mantel-Haenszel|||Test performed for responders rates at week 20||||0.084
72446012|NCT02677298|144407745|SUPERIORITY||||||<|0.001||||||For the testing a hierarchical approach has been applied. The result of this test is considered confirmative if the test of the Primary and all previous Secondary Outcome Measures show a confirmatory result at a one-sided significance level of 0.025.|Wilcoxon (Mann-Whitney)|||Test performed for the Modified Skindex-16 (GL-QoL) Emotional domain change from baseline at week 4||||<0.001
72446013|NCT02677298|144407745|SUPERIORITY||||||<|0.001||||||For the testing a hierarchical approach has been applied. The result of this test is considered confirmative if the test of the Primary and all previous Secondary Outcome Measures show a confirmatory result at a one-sided significance level of 0.025.|Wilcoxon (Mann-Whitney)|||This test was performed for the Modified Skindex-16 (GL-QoL) Functioning domain - Change from baseline at Week 4||||<0.001
72446014|NCT02677298|144407745|SUPERIORITY||||||<|0.001||||||For the testing a hierarchical approach has been applied. The result of this test is considered confirmative if the test of the Primary and all previous Secondary Outcome Measures show a confirmatory result at a one-sided significance level of 0.025.|Wilcoxon (Mann-Whitney)|||This test was performed for the Modified Skindex-16 (GL-QoL) Overall score||||<0.001
72446015|NCT02677298|144407745|SUPERIORITY||||||<|0.001||||||For the testing a hierarchical approach has been applied. The result of this test is considered confirmative if the test of the Primary and all previous Secondary Outcome Measures show a confirmatory result at a one-sided significance level of 0.025.|Wilcoxon (Mann-Whitney)|||Test was performed for the FACE-Q Appraisal of Lines Between Eyebrows Scale - Change from Baseline at Week 4||||<0.001
72446016|NCT02677298|144407745|SUPERIORITY||||||<|0.001||||||For the testing a hierarchical approach has been applied. The result of this test is considered confirmative if the test of the Primary and all previous Secondary Outcome Measures show a confirmatory result at a one-sided significance level of 0.025.|Wilcoxon (Mann-Whitney)|||Test was performed for the FACE-Q Age Appraisal VAS score||||<0.001
72560862|NCT00688844|144652286|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.005401|STANDARD_DEVIATION|0.0243|<|0.001|||||||t-test, 2 sided|||Objective was to evaluate total body bone mineral density (BMD) one year via DXA in PKU patients introduced to sapropterin after baseline. Study was prospective cohort in design.||||<0.001
72560863|NCT00688844|144652287|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.419224|STANDARD_DEVIATION|3.4666||0.017941|||||||t-test, 2 sided|||Objective was to evaluate % lean mass across one year via DXA in PKU patients introduced to sapropterin after baseline. Study was prospective cohort in design.||||0.017941
72560864|NCT00688844|144652288|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.208889|STANDARD_DEVIATION|3.51967||0.026009|||||||t-test, 2 sided|||Objective was to evaluate % fat mass across one year via DXA in PKU patients introduced to sapropterin after baseline. Study was prospective cohort in design.||||0.026009
72389801|NCT01847274|144287527|SUPERIORITY|||||||0.0259|||||||Pearson's Chi-squared test|||||||0.0259
72389802|NCT01847274|144287527|SUPERIORITY|||||||0.2798|||||||Pearson's Chi-squared test|Analysis for gBRCA Niraparib vs gBRCA Placebo-Hands||||||0.2798
72389803|NCT01847274|144287534|SUPERIORITY||Ratio of Least square mean|1.1|||||TWO_SIDED|90.0|0.997|1.216||||||||1.216|0.997|
72389804|NCT01847274|144287535|SUPERIORITY||Ratio of Least square mean|1.068|||||TWO_SIDED|90.0|0.978|1.166||||||||1.166|0.978|
72389805|NCT01847274|144287536|SUPERIORITY||Ratio of Least square mean|0.785|||||TWO_SIDED|90.0|0.695|0.886||||||||0.886|0.695|
72389806|NCT00289991|144287545|NON_INFERIORITY_OR_EQUIVALENCE|Assuming a true success rate of 50% in voriconazole (Vori) treatment (Tx) group and 45% in itraconazole (Itra) Tx group, sample size of 232 subjects per group=90% power to demonstrate non-inferiority of Vori to Itra using pre-specified non-inferiority margin of -10%. Sample has at least 80% power to demonstrate superiority of Vori over Itra if true success rates for Vori and Itra are 57% and 44% respectively. Based on this, up to 500 subjects were to be enrolled to obtain 464 eligible subjects.|percent difference adjusted proportions|16.4|||||TWO_SIDED|95.0|7.7|25.1|||Difference in adjusted responder rates|Difference in adjusted responder rates using Fleiss method|Overall treatment difference in adjusted proportions (expressed as percentages) calculated using Fleiss method.|"Non-inferiority inferred if lower limit of the 2-sided 95 percent (%) confidence interval (CI) for the difference between the voriconazole and itraconazole treatment groups in the adjusted proportion of subjects classified as Success at Day 180 after transplant is above -10%. Superiority achieved if 2-sided 95% CI for difference between these treatment groups in the adjusted proportion of subjects classified as Success at Day 180 after transplant does not include zero and is positive."||25.1|7.7|
72389807|NCT00289991|144287546|NON_INFERIORITY_OR_EQUIVALENCE|"Non-inferiority inferred if lower limit of the 2-sided 95% confidence interval (CI) for the difference between the voriconazole and itraconazole treatment groups in the adjusted proportion of subjects classified as Success at Day 100 after transplant is above -10%. Superiority achieved if 2-sided 95% CI for difference between these treatment groups in the adjusted proportion of subjects classified as Success at Day 100 after transplant does not include zero and is positive."|percent difference adjusted proportions|15.4|||||TWO_SIDED|95.0|6.6|24.2|||Difference in adjusted responder rates|Difference in adjusted responder rates using the Fleiss method.|Overall treatment difference in adjusted proportions (expressed as percentages) calculated using Fleiss method.|||24.2|6.6|
72389808|NCT00289991|144287548|SUPERIORITY_OR_OTHER||difference in proportions: percent|-0.4||||0.7114|TWO_SIDED|95.0|-2.2|1.5|||Difference in proportions|Difference in proportions (approximate result)|Approximate 2-sided 95 percent (%) confidence interval for the difference in proportions.|Day 100; difference in proportions (expressed as percentages), voriconazole relative to itraconazole.||1.5|-2.2|0.7114
72389809|NCT00289991|144287548|SUPERIORITY_OR_OTHER||difference in proportion: percent|-0.3||||0.7759|TWO_SIDED|95.0|-2.5|1.9|||Difference in proportions|Difference in proportions (approximate result).|Approximate 2-sided 95 percent (%) confidence interval for the difference in proportions.|Day 180; difference in proportions (expressed as percentages), voriconazole relative to itraconazole.||1.9|-2.5|0.7759
72389810|NCT00289991|144287549|SUPERIORITY_OR_OTHER||difference in proportions: percent|0.3|||||TWO_SIDED|95.0|-6.3|6.9|||Difference in proportions|Difference in proportions (approximate result)|Approximate 2-sided 95% confidence interval for the difference in proportions.|Day 180; difference in proportions (expressed as a percentage), voriconazole relative to itraconazole.||6.9|-6.3|
72389811|NCT00289991|144287550|SUPERIORITY_OR_OTHER|||||||0.0026||95.0|||||Wilcoxon (Mann-Whitney)|2-sided Wilcoxon (Mann-Whitney)||Mann-Whitney test used to investigate the null hypothesis that the times to discontinuation of study medication in each treatment group come from the same distribution.||||0.0026
72389812|NCT00289991|144287551|SUPERIORITY_OR_OTHER||difference in proportions: percent|-4.8||||0.2487|TWO_SIDED|95.0|-13.0|3.4|||Difference in proportions|Difference in proportions (approximate result)|Approximate 2-sided 95 percent % confidence interval for the difference in proportions.|Day 365; difference in proportions (expressed as a percentage), voriconazole relative to itraconazole.||3.4|-13.0|0.2487
72389813|NCT00289991|144287553|SUPERIORITY_OR_OTHER||difference in proportions: percent|-8.8||||0.057|TWO_SIDED|95.0|-17.8|0.3|||Difference in proportions|Difference in proportions (approximate result)|Approximate 2-sided 95% confidence interval for the difference in proportions.|Difference in proportions (expressed as a percentage), voriconazole relative to itraconazole.||0.3|-17.8|0.0570
72389814|NCT01606007|144287564|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.59|STANDARD_ERROR_OF_MEAN|0.1112|<|0.0001|TWO_SIDED|95.0|-0.81|-0.37||Primary endpoint was tested at alpha=0.05; significance was claimed only if Saxagliptin+Dapagliflozin+Metformin was superior to both Saxagliptin+Metformin and Dapagliflozin+Metformin.|Mixed Models Analysis|||||-0.37|-0.81|<0.0001
72389815|NCT01606007|144287564|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.27|STANDARD_ERROR_OF_MEAN|0.1108||0.0166|TWO_SIDED|95.0|-0.48|-0.05||Primary endpoint was tested at alpha=0.05; significance was claimed only if Saxagliptin+Dapagliflozin+Metformin was superior to both Saxagliptin+Metformin and Dapagliflozin+Metformin.|Mixed Models Analysis|||||-0.05|-0.48|0.0166
72389816|NCT01606007|144287565|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-44.0|STANDARD_ERROR_OF_MEAN|4.914|<|0.0001|TWO_SIDED|95.0|-53.7|-34.3||Each secondary endpoint was tested at alpha=0.05; significance was claimed only if Saxagliptin+Dapagliflozin+Metformin was superior to both Saxagliptin+Metformin and Dapagliflozin+Metformin.|ANCOVA|||LOCF||-34.3|-53.7|<0.0001
72497731|NCT01552902|144525599|SUPERIORITY_OR_OTHER_LEGACY||Difference in LSM|-3.4|||=|0.0013|TWO_SIDED|95.0|-5.4|-1.3|||Mixed Models Analysis|||The least squares mean (LSM), the difference in LSM and its 95% confidence interval (CI), and the p-value were from a mixed effects model for repeated measures that included treatment group, visit, interaction of the treatment group with the visit as factors, baseline score as a covariate, and an adjustment for the interaction of the baseline score with the visit. The model was based on Restricted maximum likelihood (REML) method of estimation and utilized an unstructured covariance.||-1.3|-5.4|= 0.0013
72497732|NCT01552902|144525599|SUPERIORITY_OR_OTHER_LEGACY||Difference in LSM|-8.5|||<|0.0001|TWO_SIDED|95.0|-11.0|-6.0|||Mixed Models Analysis|||The LSM, the difference in LSM and its 95% CI, and the p-value were from a mixed effects model for repeated measures that included treatment group, visit, interaction of the treatment group with the visit as factors, baseline score as a covariate, and an adjustment for the interaction of the baseline score with the visit. The model was based on REML method of estimation and utilized an unstructured covariance.||-6|-11|< 0.0001
72497733|NCT01552902|144525599|SUPERIORITY_OR_OTHER_LEGACY||Difference in LSM|-5.1|||<|0.0001|TWO_SIDED|95.0|-7.6|-2.6|||Mixed Models Analysis|||The LSM, the difference in LSM and its 95% CI, and the p-value were from a mixed effects model for repeated measures that includes treatment group, visit, interaction of the treatment group with the visit as factors, baseline score as a covariate, and an adjustment for the interaction of the baseline score with the visit. The model was based on REML method of estimation and utilized an unstructured covariance.||-2.6|-7.6|< 0.0001
72497734|NCT02064764|144525613|OTHER|Log-Rank Test For Comparing Treatment and Control||||||0.28|||||||Log Rank|||||||0.28
72497735|NCT02064764|144525614|OTHER|||||||0.7348|||||||Log Rank|||||||0.7348
72497736|NCT06415305|144525623|SUPERIORITY||||||<|0.008|||||||Wilcoxon signed rank tests|||||||<0.008
72497737|NCT06415305|144525624|SUPERIORITY|||||||0.009|||||||Wilcoxon signed rank tests|||||||0.009
72497738|NCT06415305|144525625|SUPERIORITY|||||||0.008|||||||Wilcoxon signed rank tests|||||||0.008
72560865|NCT00688844|144652289|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-67.5187|STANDARD_DEVIATION|362.9412||0.303864|||||||t-test, 2 sided|||Objective was to evaluate plasma phenylalanine across one year in PKU patients introduced to sapropterin after baseline. Study was prospective cohort in design.||||0.303864
72497739|NCT06415305|144525626|SUPERIORITY|||||||0.009|||||||Wilcoxon signed rank tests|||||||0.009
72497740|NCT02487108|144525633|OTHER||LS Mean Difference|38.9|||<|0.001|TWO_SIDED|95.0|19.931|57.855|||ANCOVA|||Analysis was performed using ANCOVA with treatment and center as factors and the baseline pain intensity score as a covariate.||57.855|19.931|<0.001
72497741|NCT02487108|144525633|OTHER||LS Mean Difference|44.0|||<|0.001|TWO_SIDED|95.0|25.122|62.881|||ANCOVA|||Analysis was performed using ANCOVA with treatment and center as factors and the baseline pain intensity score as a covariate.||62.881|25.122|<0.001
72497742|NCT02487108|144525633|OTHER||LS Mean Difference|53.4|||<|0.001|TWO_SIDED|95.0|34.589|72.282|||ANCOVA|||Analysis was performed using ANCOVA with treatment and center as factors and the baseline pain intensity score as a covariate.||72.282|34.589|<0.001
72497743|NCT00600171|144525668|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.064||||0.208|TWO_SIDED|95.0|-0.036|0.164|||ANCOVA|||||0.164|-0.036|0.208
72497744|NCT00600171|144525668|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.069||||0.169|TWO_SIDED|95.0|-0.029|0.168|||ANCOVA|||||0.168|-0.029|0.169
72497745|NCT00600171|144525668|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.13||||0.011|TWO_SIDED|95.0|0.03|0.23|||ANCOVA|||||0.230|0.030|0.011
72497746|NCT00600171|144525668|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.121||||0.016|TWO_SIDED|95.0|0.023|0.22|||ANCOVA|||||0.220|0.023|0.016
72497747|NCT00600171|144525668|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.162||||0.001|TWO_SIDED|95.0|0.062|0.261|||ANCOVA|||||0.261|0.062|0.001
72497748|NCT00849017|144525688|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.84|||<|0.0001|TWO_SIDED|95.0|-1.11|-0.58|||ANCOVA|||||-0.58|-1.11|<0.0001
72497749|NCT00849017|144525688|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.04|||<|0.0001|TWO_SIDED|95.0|-1.31|-0.77|||ANCOVA|||||-0.77|-1.31|<0.0001
72497750|NCT01111305|144525727|EQUIVALENCE|Equivalence is defined as p≥0.05||||||0.028|||||||Wilcoxon (Mann-Whitney)|||||||0.028
72497751|NCT00624520|144525750|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|891.0||||0.18|TWO_SIDED|||||Statistical Analysis presented for comparison groups Cognitive Behavioral Stress Management vs. Patient Education at 6 months post|ANOVA|||"Initial sample size calculation, based on previous published data of effects sizes of anger stress management on heart rate and blood pressure responses in a veteran population, indicated a study population of 138 patients should detect a reduction in Double Product response to mental stress following psychological intervention, with over 90% power, assuming 20% drop-out rate."||||0.18
72497752|NCT00624520|144525751|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.0||||0.02|TWO_SIDED||||||ANOVA|||||||0.02
72497753|NCT00624520|144525752|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.0||||0.003|TWO_SIDED||||||ANOVA|||||||0.003
72497754|NCT00624520|144525753|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.0||||0.011|TWO_SIDED||||||ANOVA|||||||0.011
72497755|NCT00624520|144525754|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.0||||0.048|TWO_SIDED||||||ANOVA|||||||0.048
72497756|NCT00624520|144525755|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.0||||0.01|TWO_SIDED||||||ANOVA|||||||0.01
72497757|NCT00624520|144525756|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|15.0||||0.01|TWO_SIDED||||||ANOVA|||||||0.01
72497758|NCT00624520|144525757|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.02||||0.01|TWO_SIDED||||||ANOVA|||||||0.01
72497759|NCT00624520|144525758|SUPERIORITY_OR_OTHER|||||||0.21|TWO_SIDED||||||Fisher Exact|||||||0.21
72497760|NCT00624520|144525759|SUPERIORITY_OR_OTHER||Effect size (Cohen's d)|0.38||||0.025|TWO_SIDED|||||P-value refers to a repeated measures within-group comparison in the CBSM group using ANCOVA with baseline DP elevation as covariate from baseline to 3 months post.|ANCOVA||Range of Cohen's d for small effect is 0.20 - 0.50|||||0.025
72560866|NCT00688844|144652290|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.9549|STANDARD_DEVIATION|20.10814||0.00088|||||||t-test, 2 sided|||Objective was to evaluate protein intake (grams per day) across one year in PKU patients introduced to sapropterin after baseline. Study was prospective cohort in design.||||0.00088
72497761|NCT00624520|144525760|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|80.0||||0.81|TWO_SIDED|||||Statistical Analysis presented for comparison groups Cognitive Behavioral Stress Management vs. Patient Education at 6 months post|ANOVA|||"Initial sample size calculation, based on previous published data of effects sizes of anger stress management on heart rate and blood pressure responses in a veteran population, indicated a study population of 138 patients should detect a reduction in Double Product response to mental stress following psychological intervention, with over 90% power, assuming 20% drop-out rate."||||0.81
72497762|NCT01925209|144525761|SUPERIORITY_OR_OTHER||Mean Difference (Net)|17.59|STANDARD_ERROR_OF_MEAN|14.331||0.221|TWO_SIDED|99.0|-19.63|54.8|||mixed model repeated measures|||||54.80|-19.63|0.2210
72497763|NCT01925209|144525761|SUPERIORITY_OR_OTHER||Mean Difference (Net)|18.59|STANDARD_ERROR_OF_MEAN|14.176||0.1909|TWO_SIDED|99.0|-18.21|55.4|||mixed model repeated measure|||||55.40|-18.21|0.1909
72497764|NCT01925209|144525761|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.31|STANDARD_ERROR_OF_MEAN|14.121||0.9263|TWO_SIDED|99.0|-37.97|35.36|||mixed models repeated measures|||||35.36|-37.97|0.9263
72497765|NCT00110994|144525771|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.665||||0.068|TWO_SIDED|95.0|0.428|1.034|||log rank test|||||1.034|0.428|0.068
72497766|NCT00110994|144525772|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.992||||0.973|TWO_SIDED|95.0|0.627|1.57|||log rank test|||||1.570|0.627|0.973
72446017|NCT03232138|144407807|EQUIVALENCE|2-sided P-value in the analysis|Mean Difference (Final Values)|0.22||||0.452|TWO_SIDED|95.0|0.03|0.41||Hypothesis: sulforaphane treatment slows or reverse the progression of lung histological lesions or lower the dysplasia score.|ANCOVA|ANCOVA model includes baseline average endobronchial histopathological scores,age,sex,cigarettes per day,years of smoking, years since quit smoking.||Derived from ANCOVA model with adjustment for baseline average endobronchial histopathological scores, age, sex, cigarettes per day, years of smoking, and years since quit smoking.||0.41|0.03|0.452
72446018|NCT03232138|144407807|EQUIVALENCE|2-sided P-value in the analysis|Mean Difference (Final Values)|0.12||||0.452|TWO_SIDED|95.0|-0.04|0.28||Hypothesis: sulforaphane treatment slows or reverse the progression of lung histological lesions or lower the dysplasia score.|ANCOVA|ANCOVA model includes baseline average endobronchial histopathological scores,age,sex,cigarettes per day,years of smoking, years since quit smoking||Derived from ANCOVA model with adjustment for baseline average endobronchial histopathological scores, age, sex, cigarettes per day, years of smoking, and years since quit smoking.||0.28|-0.04|0.452
72446019|NCT03232138|144407808|EQUIVALENCE|2-sided P-value in the analysis||||||0.738||||||Hypothesis: Sulforaphane treatment inhibits or reduces number of Ki-67 positive nuclei in bronchial biopsy as compared with the placebo.|Analysis of Covariance|||All positive nuclei. Mean (95%CI) changes in baseline.||||0.738
72446020|NCT03232138|144407808|EQUIVALENCE|2-sided P-value in the analysis||||||0.78||||||Hypothesis: Sulforaphane treatment inhibits or reduces number of Ki-67 positive nuclei in bronchial biopsy as compared with the placebo.|Analysis of Covariance|||Weak-intensity positive nuclei. Mean (95%CI) baseline.||||0.780
72497767|NCT00110994|144525774|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.619||||0.039|TWO_SIDED|95.0|0.391|0.98|||log rank test|||||0.980|0.391|0.039
72497768|NCT00110994|144525775|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.427||||0.194|TWO_SIDED|95.0|0.114|1.601|||log rank test|||||1.601|0.114|0.194
72497769|NCT00110994|144525777|SUPERIORITY_OR_OTHER|||||||0.908||95.0|||||t-test, 2 sided|||||||0.908
72497770|NCT00110994|144525778|SUPERIORITY_OR_OTHER|||||||0.89||95.0|||||t-test, 2 sided|||||||0.890
72560867|NCT00688844|144652291|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.131676|STANDARD_DEVIATION|0.797247||0.3811|||||||t-test, 2 sided|||Objective was to evaluate dietary phenylalanine intake across one year in PKU patients introduced to sapropterin after baseline. Study was prospective cohort in design.||||0.3811
72560868|NCT01374451|144652293|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.991||||0.488|TWO_SIDED|95.0|0.636|1.543|||Log Rank|||||1.543|0.636|0.488
72446021|NCT03232138|144407808|EQUIVALENCE|2-sided P-value in the analysis||||||0.733||||||Hypothesis: Sulforaphane treatment inhibits or reduces number of Ki-67 positive nuclei in bronchial biopsy as compared with the placebo.|Analysis of Covariance|||Moderate intensity positive nuclei. Mean (95%CI) changes in baseline.||||0.733
72497771|NCT00110994|144525779|SUPERIORITY_OR_OTHER|||||||0.201||95.0|||||t-test, 2 sided|||||||0.201
72497772|NCT00110994|144525780|SUPERIORITY_OR_OTHER|||||||0.168||95.0|||||t-test, 2 sided|||||||0.168
72497773|NCT01570244|144525796|NON_INFERIORITY_OR_EQUIVALENCE|investigation of relative bioavailability (no formal testing)|Geometric Mean Ratio|140.96|STANDARD_DEVIATION|8.1|||TWO_SIDED|90.0|133.84|148.47|||ANOVA||the standard deviation is actually the geometric coefficient of variation|relative bioavailability comparison (Microgynon + Faldaprevir : Microgynon) of Ethinylestradiol||148.47|133.84|
72497774|NCT01570244|144525797|NON_INFERIORITY_OR_EQUIVALENCE|investigation of relative bioavailability (no formal testing)|Odds Ratio (OR)|114.82|STANDARD_DEVIATION|13.2|||TWO_SIDED|90.0|105.49|124.97|||ANOVA||the standard deviation is actually the geometric coefficient of variation|relative bioavailability comparison (Microgynon + Faldaprevir : Microgynon) of Ethinylestradiol||124.97|105.49|
72619328|NCT02683954|144769265|SUPERIORITY_OR_OTHER|||||||0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Normality of numerical data distribution was examined by the Shapiro-Wilk. Normally distributed numerical variables were presented as mean±SD and inter-group differences were compared using unpaired t test. Skewed numerical variables were presented as median and interquartile range and between-group differences were compared using Mann-Whitney U test. Ordinal data were compared using the chi-squared test for trend. Correlations among numerical variables were tested by Spearman rank correlation.||||0.05
72619329|NCT03142451|144769283|SUPERIORITY||Mean Difference (Final Values)|2.21|STANDARD_ERROR_OF_MEAN|0.749||0.0031|TWO_SIDED|95.0|0.75|3.68|||ANCOVA|Analysis of covariance (ANCOVA) model includes treatment, baseline inflammatory lesion count, and analysis center.||||3.68|0.75|0.0031
72497775|NCT01570244|144525798|NON_INFERIORITY_OR_EQUIVALENCE|investigation of relative bioavailability (no formal testing)|Geometric Mean Ratio|171.37|STANDARD_DEVIATION|10.5|||TWO_SIDED|90.0|160.2|183.33|||ANOVA||the standard deviation is actually the geometric coefficient of variation|relative bioavailability comparison (Microgynon + Faldaprevir : Microgynon) of Ethinylestradiol||183.33|160.20|
72497776|NCT01570244|144525801|NON_INFERIORITY_OR_EQUIVALENCE|investigation of relative bioavailability (no formal testing)|Geometric mean ratio|140.53|STANDARD_DEVIATION|4.6|||TWO_SIDED|90.0|136.4|144.78|||ANOVA||the standard deviation is actually the geometric coefficient of variation|relative bioavailability comparison (Microgynon + Faldaprevir : Microgynon) of Levonorgestrel||144.78|136.40|
72446022|NCT03232138|144407808|EQUIVALENCE|2-sided P-value in the analysis||||||0.751||||||Hypothesis: Sulforaphane treatment inhibits or reduces number of Ki-67 positive nuclei in bronchial biopsy as compared with the placebo.|Analysis of Covariance|||Strong-Intensity positive nuclei. Mean (95%CI) changes in baseline.||||0.751
72446023|NCT03232138|144407808|EQUIVALENCE|2-sided P-value in the analysis||||||0.014||||||Hypothesis: Sulforaphane treatment inhibits or reduces number of Ki-67 positive nuclei in bronchial biopsy as compared with the placebo.|Analysis of Covariance|Analysis of Covariance with adjustment for age, sex, cigarettes/day, years of smoking, years of quit smoking, baseline values of Ki-67 positive nuclei||All positive nuclei. Mean (95%CI) changes from pre to pos treatment.||||0.014
72446024|NCT03232138|144407808|EQUIVALENCE|2-sided P-value in the analysis||||||0.056|||||||Covariance|Analysis of Covariance adjustment age, sex, cigarettes/day, years of smoking, years of quit smoking,baseline values of the same cellular biomarker||Week intensity positive nuclei. Mean (95%CI) changes from pre to pos treatment.||||0.056
72446025|NCT03232138|144407808|EQUIVALENCE|2-sided P-value in the analysis||||||0.028|||||||Analysis of Covariance|Analysis of Covariance adjustment for age, sex, cigarettes/day, years of smoking, years of quit smoking,baseline values of the same cellular biomarker||Moderate Intensity positive nuclei. Mean (95%CI) changes from pre to pos treatment.||||0.028
72446026|NCT03232138|144407808|EQUIVALENCE|2-sided P-value in the analysis||||||0.004|||||||Analysis of Covariance|Analysis of Covariance adjustment for age, sex, cigarettes/day, years of smoking, years of quit smoking,baseline values of the same cellular biomarker||Strong intensity positive nuclei. Mean (95%CI) changes from pre to pos treatment.||||0.004
72446027|NCT03232138|144407809|EQUIVALENCE|2-sided P-value in the analysis, Mean (95%CI) at baseline for positive cells. TUNEL positive nuclei (counts/µm2) From Analysis of Covariance with adjustment for age, sex, cigarettes/day, years of smoking, years of quit smoking and baseline values of the same cellular biomarker.||||||0.377||||||Hypothesis: Sulforaphane treatment has significant impact on number of TUNEL positive nuclei in bronchial biopsies compared with the place|Analysis of Covariance|Analysis of Covariance with adjustment for age, sex, cigarettes/day, years of smoking, years of quit smoking, baseline values of positive TUNEL nuclei||All positive nuclei. Mean (95%CI) baseline.||||0.377
72446028|NCT03232138|144407809|EQUIVALENCE|2-sided P-value in the analysis||||||0.413||||||Hypothesis: Sulforaphane treatment inhibits or reduces number of Ki-67 positive nuclei in bronchial biopsy as compared with the placebo.|Analysis of Covariance|||Weak-intensity positive nuclei. Mean (95%CI) baseline.||||0.413
72446029|NCT03232138|144407809|EQUIVALENCE|2-sided P-value in the analysis, Mean (95%CI) at baseline Moderate-intensity positive nuclei. TUNEL positive (counts/µm2) From Analysis of Covariance with adjustment for age, sex, cigarettes/day, years of smoking, years of quit smoking and baseline values of the same cellular biomarker.||||||0.338||||||Hypothesis: Sulforaphane treatment has significant impact on number of TUNEL positive nuclei in bronchial biopsies compared with the place|Analysis of Covariance|Analysis of Covariance with adjustment for age, sex, cigarettes/day, years of smoking, years of quit smoking, baseline values of positive TUNEL nuclei||Moderate Intensity positive nuclei. Mean (95%CI) at baseline.||||0.338
72446030|NCT03232138|144407809|EQUIVALENCE|2-sided P-value in the analysis, Mean (95%CI) at baseline for positive cells. TUNEL positive nuclei (counts/µm2) From Analysis of Covariance with adjustment for age, sex, cigarettes/day, years of smoking, years of quit smoking and baseline values of the same cellular biomarker.||||||0.547||||||Hypothesis: Sulforaphane treatment has significant impact on number of TUNEL positive nuclei in bronchial biopsies|Analysis of Covariance|Analysis of Covariance with adjustment for age, sex, cigarettes/day, years of smoking, years of quit smoking, baseline values of positive TUNEL nuclei||Strong-intensity positive nuclei. Mean (95%CI) baseline.||||0.547
72446031|NCT03232138|144407809|EQUIVALENCE|used 2-sided P-value in the analysis, Mean (95%CI) changes from pre to pos treatment for all positive cells. TUNEL all positive nuclei (counts/µm2) From Analysis of Covariance with adjustment for age, sex, cigarettes/day, years of smoking, years of quit smoking and baseline values of the same cellular biomarker.||||||0.291||||||Hypothesis: Sulforaphane treatment has significant impact on number of TUNEL positive nuclei in bronchial biopsies|Analysis of Covariance|Analysis of Covariance with adjustment for age, sex, cigarettes/day, years of smoking, years of quit smoking, baseline values of positive TUNEL nuclei||All positive nuclei. Mean (95%CI) changes from pre to pos treatment.||||0.291
72446032|NCT03232138|144407809|EQUIVALENCE|2-sided P-value in the analysis, Mean (95%CI) changes from pre to pos treatment for positive cells. TUNEL all positive nuclei (counts/µm2) From Analysis of Covariance with adjustment for age, sex, cigarettes/day, years of smoking, years of quit smoking and baseline values of the same cellular biomarker.||||||0.552||||||Hypothesis: Sulforaphane treatment has significant impact on number of TUNEL positive nuclei in bronchial biopsies|Analysis of Covariance|Analysis of Covariance with adjustment for age, sex, cigarettes/day, years of smoking, years of quit smoking, baseline values of positive TUNEL nuclei||Weak-intensity positive nuclei. Mean (95%CI) changes from pre to pos treatment.||||0.552
72497777|NCT01570244|144525802|NON_INFERIORITY_OR_EQUIVALENCE|investigation of relative bioavailability (no formal testing)|Geometric Mean Ratio|115.28|STANDARD_DEVIATION|6.1|||TWO_SIDED|90.0|110.81|119.92|||ANOVA||the standard deviation is actually the geometric coefficient of variation|relative bioavailability comparison (Microgynon + Faldaprevir : Microgynon) of Levonorgestrel||119.92|110.81|
72619330|NCT03142451|144769284|SUPERIORITY||Risk Ratio (RR)|1.21||||0.0273|TWO_SIDED|95.0|1.022|1.434||The p-value is for the null hypothesis that the combined risk ratio equals 1.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel Test Stratified by Analysis Center||||1.434|1.022|0.0273
72389817|NCT01606007|144287565|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.1|STANDARD_ERROR_OF_MEAN|4.923||0.0639|TWO_SIDED|95.0|-18.8|0.5||Each secondary endpoint was tested at alpha=0.05; significance testing stops at the endpoint where p-value\>0.05.|ANCOVA|||LOCF||0.5|-18.8|0.0639
72389818|NCT01606007|144287566|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-23.8|STANDARD_ERROR_OF_MEAN|3.988|||TWO_SIDED|95.0|-31.6|-15.9|||||ANCOVA was applied for comparison, but p-value was not reported because at least one prior test in the hierarchical testing procedure yielded p-value\>0.05.|||-15.9|-31.6|
72389819|NCT01606007|144287566|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.1|STANDARD_ERROR_OF_MEAN|3.957|||TWO_SIDED|95.0|-13.8|1.7|||||ANCOVA was applied for comparison, but p-value was not reported because at least one prior test in the hierarchical testing procedure yielded p-value\>0.05.|||1.7|-13.8|
72389820|NCT01606007|144287567|SUPERIORITY_OR_OTHER||Mean difference in percentages|23.1|STANDARD_ERROR_OF_MEAN|4.282|||TWO_SIDED|95.0|14.7|31.5|||||Modified Logistic Regression was applied for comparison, but p-value was not reported because at least one prior test in the hierarchical testing procedure yielded p-value\>0.05.|||31.5|14.7|
72497778|NCT01570244|144525803|NON_INFERIORITY_OR_EQUIVALENCE|investigation of relative bioavailability (no formal testing)|Geometric Mean Ratio|153.85|STANDARD_DEVIATION|8.2|||TWO_SIDED|90.0|145.99|162.14|||ANOVA||the standard deviation is actually the geometric coefficient of variation|relative bioavailability comparison (Microgynon + Faldaprevir : Microgynon) of Levonorgestrel||162.14|145.99|
72497779|NCT05617521|144525807|SUPERIORITY|Sample size was assessed over the primary outcome of the study based on pre-experimental data estimation. It was calculated that 142 participants were needed to detect a 60-second difference in CIT, with 90% power and two-side alpha 0.05. It was found that 186 participants were needed to detect a 20% reduction in the use of ancillary maneuvers. As a preventive measure in case of withdrawal or exclusion, the sample was expanded by 10%, a total of 206 patients||||||0.008||||||The comparative analysis of the CIT was previously subjected to normality evaluation by the Shapiro-Wilk test. According to the rejection of normal distribution, comparative data analysis has been performed with a two-way Mann-Whitney U test|Wilcoxon (Mann-Whitney)|||||||0.008
72497780|NCT05617521|144525808|SUPERIORITY|Sample size was assessed over the primary outcome of the study based on pre-experimental data estimation. It was calculated that 142 participants were needed to detect a 60-second difference in CIT, with 90% power and two-side alpha 0.05. It was found that 186 participants were needed to detect a 20% reduction in the use of ancillary maneuvers. As a preventive measure in case of withdrawal or exclusion, the sample was expanded by 10%, a total of 206 patients.|||||<|0.001||||||For the comparison of abdominal pressure, Pearson chi-square test was used. The statistical significance level was accepted as p \<0.05|Chi-squared|||||||<0.001
72497781|NCT05617521|144525809|SUPERIORITY||||||<|0.001||||||The comparative analysis of the CIL was previously subjected to normality evaluation by the Shapiro-Wilk test. According to the rejection of normal distribution, comparative data analysis has been performed with a two-way Mann-Whitney U test|Wilcoxon (Mann-Whitney)|||||||<0.001
72497782|NCT05617521|144525810|SUPERIORITY|||||||0.321|||||||Chi-squared|||||||0.321
72497783|NCT05617521|144525811|SUPERIORITY|||||||0.75|||||||Fisher Exact|||||||0.75
72497784|NCT05617521|144525812|SUPERIORITY|||||||0.005|||||||Chi-squared|||||||0.005
72497785|NCT05617521|144525813|OTHER|||||||0.8|||||||Fisher Exact|||||||0.8
72497786|NCT05617521|144525815|SUPERIORITY|||||||0.12|||||||Fisher Exact|||||||0.12
72497787|NCT05617521|144525816|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
72497788|NCT05617521|144525817|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
72619331|NCT03142451|144769285|SUPERIORITY||Risk Ratio (RR)|1.21||||0.0171|TWO_SIDED|95.0|1.028|1.425||The p-value is for the null hypothesis that the combined risk ratio equals 1.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel Test Stratified by Analysis Center||||1.425|1.028|0.0171
72389821|NCT01606007|144287567|SUPERIORITY_OR_OTHER||Mean difference in percentages|19.1|STANDARD_ERROR_OF_MEAN|4.587|||TWO_SIDED|95.0|10.1|28.1|||||Modified Logistic Regression was applied for comparison, but p-value was not reported because at least one prior test in the hierarchical testing procedure yielded p-value\>0.05.|||28.1|10.1|
72389822|NCT01606007|144287568|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.05|STANDARD_ERROR_OF_MEAN|0.3451|||TWO_SIDED|95.0|-2.73|-1.37|||||ANCOVA was applied for comparison, but p-value was not reported because at least one prior test in the hierarchical testing procedure yielded p-value\>0.05.|||-1.37|-2.73|
72389823|NCT00332163|144287569|SUPERIORITY_OR_OTHER||Difference|-33.0|||||TWO_SIDED|95.0|-51.0|-14.0|||||Difference = Pre-emptive - Reactive|||-14|-51|
72389824|NCT00332163|144287570|SUPERIORITY_OR_OTHER||Difference|-22.0|||||TWO_SIDED|95.0|-42.0|-3.0|||||Difference = Pre-emptive - Reactive|||-3|-42|
72389825|NCT00332163|144287571|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.4|||||TWO_SIDED|95.0|0.2|0.7|||||Hazard ratio estimated from a Cox Proportional Hazards regression model with an indicator for treatment (pre-emptive vs. reactive), stratified by chemotherapy stratum (Q2W vs Q3W).|||0.7|0.2|
72389826|NCT00332163|144287573|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.4|||||TWO_SIDED|95.0|0.2|0.7|||||Hazard ratio estimated from a Cox Proportional Hazards regression model with an indicator for treatment (Pre-emptive vs. Reactive) stratified by chemotherapy stratum (Q2W vs Q3W).|||0.7|0.2|
72389827|NCT00332163|144287574|SUPERIORITY_OR_OTHER||Difference|-4.0|||||TWO_SIDED|95.0|-16.0|7.0|||||Difference = Pre-emptive - Reactive|||7|-16|
72389828|NCT00332163|144287575|SUPERIORITY_OR_OTHER||Difference|0.0|||||TWO_SIDED|95.0|-10.0|10.0|||||Difference = Pre-emptive - Reactive|||10|-10|
72389829|NCT00332163|144287576|SUPERIORITY_OR_OTHER||Difference|4.0|||||TWO_SIDED|95.0|-9.0|17.0|||||Rate difference = Pre-emptive - Reactive|||17|-9|
72389830|NCT00332163|144287577|SUPERIORITY_OR_OTHER||Difference|-1.0|||||TWO_SIDED|95.0|-21.0|18.0|||||Rate difference = Pre-emptive - Reactive|||18|-21|
72389831|NCT00332163|144287578|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.3|||||TWO_SIDED|95.0|0.9|2.0|||||Hazard ratio estimated from a Cox Proportional Hazards regression model with an indicator for treatment (Pre-emptive vs. Reactive) stratified by chemotherapy stratum (Q2W vs Q3W).|||2.0|0.9|
72389832|NCT00332163|144287579|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.9|||||TWO_SIDED|95.0|0.6|1.5|||||Hazard ratio estimated from a Cox Proportional Hazards regression model with an indicator for treatment (Pre-emptive vs. Reactive) stratified by chemotherapy stratum (Q2W vs Q3W).|||1.5|0.6|
72389833|NCT00332163|144287580|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.2|||||TWO_SIDED|95.0|0.7|2.1|||||Hazard ratio estimated from a Cox Proportional Hazards regression model with an indicator for treatment (Pre-emptive vs. Reactive) stratified by chemotherapy stratum (Q2W vs Q3W).|||2.1|0.7|
72497789|NCT05617521|144525818|SUPERIORITY|Sample size was assessed over the primary outcome of the study based on pre-experimental data estimation. It was calculated that 142 participants were needed to detect a 60-second difference in CIT, with 90% power and two-side alpha 0.05. It was found that 186 participants were needed to detect a 20% reduction in the use of ancillary maneuvers. As a preventive measure in case of withdrawal or exclusion, the sample was expanded by 10%, a total of 206 patients.||||||0.01||||||For the comparison of position change, Pearson chi-square test was used. The statistical significance level was accepted as p \<0.05|Chi-squared|||||||0.01
72497790|NCT05617521|144525819|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1
72560869|NCT02846883|144652357|SUPERIORITY|These power estimates are based on linear regression of regulatory T-cell counts at each time point. These data will be summarized with the mean, median, standard deviation, standard error, minimum and maximum.|Mean Difference (Final Values)|81.0|||<|0.05|TWO_SIDED|95.0||||P value is adjusted for multiple comparisons|Regression, Cox|See above|Estimates for the differences in the secondary endpoints will be used to perform a power estimation using a Monte Carlo simulation method.|The primary statistical evaluation for Aim 1 will focus on the chronologically increasing counts of T-regulatory cells over time following MSC administration in both delivery groups. Using the pattern of increased counts with time and the standard deviation reported by Ito and colleagues in healthy subjects, 36 subjects provides 81.0% power to detect such a change.A p value of \<0.05 will be considered significant.||||<0.05
72446033|NCT03232138|144407809|EQUIVALENCE|2-sided P-value in the analysis, Mean (95%CI) changes from pre to pos treatment for positive cells. TUNEL all positive nuclei (counts/µm2) From Analysis of Covariance with adjustment for age, sex, cigarettes/day, years of smoking, years of quit smoking and baseline values of the same cellular biomarker.||||||0.205||||||Hypothesis: Sulforaphane treatment has significant impact on number of TUNEL positive nuclei in bronchial biopsies|Analysis of Covariance|Analysis of Covariance with adjustment for age, sex, cigarettes/day, years of smoking, years of quit smoking, baseline values of positive TUNEL nuclei||Moderate-intensity positive nuclei. Mean (95%CI) changes from pre to pos treatment.||||0.205
72446034|NCT03232138|144407809|EQUIVALENCE|2-sided P-value in the analysis, Mean (95%CI) changes from pre to pos treatment for positive cells. TUNEL all positive nuclei (counts/µm2) From Analysis of Covariance with adjustment for age, sex, cigarettes/day, years of smoking, years of quit smoking and baseline values of the same cellular biomarker.||||||0.295||||||Hypothesis: Sulforaphane treatment has significant impact on number of TUNEL positive nuclei in bronchial biopsies|Analysis of Covariance|Analysis of Covariance with adjustment for age, sex, cigarettes/day, years of smoking, years of quit smoking, baseline values of positive TUNEL nuclei||Strong-intensity positive nuclei. Mean (95%CI) changes from pre to pos treatment.||||0.295
72446035|NCT03232138|144407810|EQUIVALENCE|2-sided P-value in the analysis, Mean (95%CI) baseline positive cells. Caspase-3 positive nuclei (counts/µm2) From Analysis of Covariance with adjustment for age, sex, cigarettes/day, years of smoking, years of quit smoking and baseline values of the same cellular biomarker.||||||0.295||||||Hypothesis: Sulforaphane treatment has significant impact on the number of cells with positive Caspase-3 in bronchial biopsies than the placebo.|Analysis of Covariance|Analysis of Covariance adjustment for age,sex,cigarettes/day,years of smoking,years of quit smoking,baseline values of Caspase-3 positive cells||All positive nuclei. Mean (95%CI) at baseline.||||0.295
72446036|NCT03232138|144407810|EQUIVALENCE|2-sided P-value in the analysis, Mean (95%CI) baseline positive cells. Caspase-3 positive nuclei (counts/µm2) From Analysis of Covariance with adjustment for age, sex, cigarettes/day, years of smoking, years of quit smoking and baseline values of the same cellular biomarker.||||||0.242||||||Hypothesis: Sulforaphane treatment has significant impact on the number of cells with positive Caspase-3 in bronchial biopsies than the placebo.|Analysis of Covariance|Analysis of Covariance adjustment for age,sex,cigarettes/day,years of smoking,years of quit smoking,baseline values of Caspase-3 positive cells||weak intensity positive nuclei. Mean (95%CI) at baseline.||||0.242
72446037|NCT03232138|144407810|EQUIVALENCE|-sided P-value in the analysis, Mean (95%CI) baseline positive cells. Caspase-3 positive nuclei (counts/µm2) From Analysis of Covariance with adjustment for age, sex, cigarettes/day, years of smoking, years of quit smoking and baseline values of the same cellular biomarker.||||||0.985||||||Hypothesis: Sulforaphane treatment has significant impact on the number of cells with positive Caspase-3 in bronchial biopsies than the placebo.|Analysis of Covariance|Analysis of Covariance adjustment for age,sex,cigarettes/day,years of smoking,years of quit smoking,baseline values of Caspase-3 positive cells||Moderate intensity positive nuclei. Mean (95%CI) at baseline.||||0.985
72446038|NCT03232138|144407810|EQUIVALENCE|2-sided P-value in the analysis, Mean (95%CI) baseline positive cells. Caspase-3 positive nuclei (counts/µm2) From Analysis of Covariance with adjustment for age, sex, cigarettes/day, years of smoking, years of quit smoking and baseline values of the same cellular biomarker.||||||0.547||||||Hypothesis: Sulforaphane treatment has significant impact on the number of cells with positive Caspase-3 in bronchial biopsies than the placebo.|Analysis of Covariance|Analysis of Covariance adjustment for age,sex,cigarettes/day,years of smoking,years of quit smoking,baseline values of Caspase-3 positive cells||Strong intensity positive nuclei. Mean (95%CI) at baseline.||||0.547
72446039|NCT03232138|144407810|EQUIVALENCE|used 2-sided P-value in the analysis, Mean (95%CI) changes from pre to pos treatment for all positive cells. Caspase-3 all positive nuclei (counts/µm2) From Analysis of Covariance with adjustment for age, sex, cigarettes/day, years of smoking, years of quit smoking and baseline values of the same cellular biomarker.||||||0.778||||||Hypothesis: Sulforaphane treatment has significant impact on the number of cells with positive Caspase-3 in bronchial biopsies than the placebo.|Analysis of Covariance|Analysis of Covariance adjustment for age,sex,cigarettes/day,years of smoking,years of quit smoking,baseline values of Caspase-3 positive cells||All positive nuclei. Mean (95%CI) changes from pre to pos treatment.||||0.778
72446040|NCT03232138|144407810|EQUIVALENCE|2-sided P-value in the analysis, Mean (95%CI) changes from pre to pos treatment for positive cells. Caspase-3 all positive nuclei (counts/µm2) From Analysis of Covariance with adjustment for age, sex, cigarettes/day, years of smoking, years of quit smoking and baseline values of the same cellular biomarker||||||0.685||||||Hypothesis: Sulforaphane treatment has significant impact on the number of cells with positive Caspase-3 in bronchial biopsies than the placebo.|Analysis of Covariance|Analysis of Covariance adjustment for age,sex,cigarettes/day,years of smoking,years of quit smoking,baseline values of Caspase-3 positive cells||Weak intensity positive nuclei. Mean (95%CI) changes from pre to pos treatment.||||0.685
72497791|NCT00792298|144525821|SUPERIORITY_OR_OTHER||LS Mean Difference: Night 1|12.9|||<|0.001|TWO_SIDED|95.0|9.5|16.3|||Mixed Models Analysis|||A fixed sequential testing procedure assessed statistical significance, beginning with the highest dose. The comparison of suvorexant vs placebo had to be significant at α=0.05 at both Night 1 and Week 4 in order to assess statistical significance of the comparison of suvorexant vs placebo for the next highest dose. If a non-significant result was observed at either time point, the differences between suvorexant and placebo for SE was considered nonsignificant for this and all lower doses.||16.3|9.5|<0.001
72619332|NCT03142451|144769286|SUPERIORITY||Mean Difference (Final Values)|7.62|STANDARD_ERROR_OF_MEAN|2.626||0.0039|TWO_SIDED|95.0|2.46|12.77|||ANCOVA|ANCOVA model includes treatment, Baseline inflammatory lesion count, and analysis center.||||12.77|2.46|0.0039
72560870|NCT00706719|144652360|SUPERIORITY_OR_OTHER|||||||0.118|TWO_SIDED||||||t-test, 2 sided|||Comparison of Group A and B observed values at Baseline.||||0.118
72446041|NCT03232138|144407810|EQUIVALENCE|-sided P-value in the analysis, Mean (95%CI) changes from pre to pos treatment for positive cells. Caspase-3 all positive nuclei (counts/µm2) From Analysis of Covariance with adjustment for age, sex, cigarettes/day, years of smoking, years of quit smoking and baseline values of the same cellular biomarker||||||0.469||||||Hypothesis: Sulforaphane treatment has significant impact on the number of cells with positive Caspase-3 in bronchial biopsies than the placebo.|Analysis of Covariance|Analysis of Covariance adjustment for age,sex,cigarettes/day,years of smoking,years of quit smoking,baseline values of Caspase-3 positive cells||Moderate intensity positive nuclei. Mean (95%CI) changes from pre to pos treatment.||||0.469
72446042|NCT03232138|144407810|EQUIVALENCE|2-sided P-value in the analysis, Mean (95%CI) changes from pre to pos treatment for positive cells. Caspase-3 all positive nuclei (counts/µm2) From Analysis of Covariance with adjustment for age, sex, cigarettes/day, years of smoking, years of quit smoking and baseline values of the same cellular biomarke||||||0.052||||||Hypothesis: Sulforaphane treatment has significant impact on the number of cells with positive Caspase-3 in bronchial biopsies than the placebo.|Analysis of Covariance|Analysis of Covariance adjustment for age,sex,cigarettes/day,years of smoking,years of quit smoking,baseline values of Caspase-3 positive cells||strong intensity positive nuclei. Mean (95%CI) changes from pre to pos treatment.||||0.052
72446043|NCT03232138|144407811|EQUIVALENCE|This analysis was focused on the gene set that were found to be upregulated in lung cancer. the objective was to examine if sulforaphane treatment for 12 months had any significant impact on the expression of these lung-cancer associated upregulated genes in bronchial brushing samples. A linear mixed model was used to evaluate the effect of sulforaphane treatment over time on GSVA enrichment score with adjustment for age at study entry, sex, and RNA integrity number or RIN.|Slope|0.02|STANDARD_ERROR_OF_MEAN|0.1||0.82|TWO_SIDED|||||Hypothesis: Sulforaphane treatment downregulate these genes whose over-expressions are associated with risk of lung cancer.|Mixed Models Analysis|The model includes treatment, time, time\*treatment, age at study entry, sex, and RIN.|Changes (beta) of gene expression after 12-month sulforaphane treatment.|||||0.82
72446044|NCT03232138|144407812|EQUIVALENCE|This analysis was focused on the gene set that were found to be down-regulated in lung cancer. The objective was to examine if sulforaphane treatment for 12 months had any significant impact on the expression of these lung-cancer associated down-regulated genes in bronchial brushing samples. A linear mixed model was used to evaluate the effect of sulforaphane treatment over time on GSVA enrichment score with adjustment for age at study entry, sex, and RIN.|Slope|-0.07|STANDARD_ERROR_OF_MEAN|0.1||0.5|TWO_SIDED|||||Hypothesis: Sulforaphane treatment would upregulate these genes whose down-expressions are associated with lung cancer risk.|Mixed Models Analysis|The model includes treatment, time, time\*treatment, age at study entry, sex, and RIN.|Changes (beta) of gene expression after 12-month sulforaphane treatment.|||||0.50
72446045|NCT03232138|144407813|EQUIVALENCE|This analysis was focused on the gene set that were found to be upregulated in lung pre-malignant lesions. The objective was to examine if sulforaphane treatment for 12 months would have any significant impact on the expression of these pre-malignant lesions associated upregulated genes in bronchial brushing samples. A linear mixed model was used to evaluate the effect of sulforaphane treatment over time on GSVA enrichment score with adjustment for age at study entry, sex, and RIN.|Slope|0.15|STANDARD_ERROR_OF_MEAN|0.15||0.32|TWO_SIDED|||||Hypothesis: Sulforaphane treatment would downregulate these genes whose over-expressions are associated with risk of lung pre-malignant lesions.|Mixed Models Analysis|The model includes treatment, time, time\*treatment, age at study entry, sex, and RIN.|Changes (beta) of gene expression after the 12-month sulforaphane treatment.|||||0.32
72446046|NCT03232138|144407814|EQUIVALENCE|This analysis was focused on the gene set that were found to be downregulated in lung pre-malignant lesions. The objective was to examine if sulforaphane treatment for 12 months would have any significant impact on the expression of these pre-malignant lesions associated downregulated genes in bronchial brushing samples. A linear mixed model was used to evaluate the effect of sulforaphane treatment over time on GSVA enrichment score with adjustment for age at study entry, sex, and RIN.|Slope|-0.1|STANDARD_ERROR_OF_MEAN|0.14||0.5|TWO_SIDED|||||Hypothesis: Sulforaphane treatment would upregulate these genes whose down-regulated expressions are associated with risk of lung pre-malignant lesions.|Mixed Models Analysis|The model includes treatment, time, time\*treatment, age at study entry, sex, and RIN.|Changes (beta) of gene expression after the 12-month sulforaphane treatment.|||||0.5
72446047|NCT03232138|144407815|EQUIVALENCE|This analysis was focused on the gene set that were found to be upregulated in lung cancer. The objective was to examine if sulforaphane treatment for 12 months had any significant impact on the expression of these lung-cancer associated upregulated genes in nasal brushing samples. A linear mixed model was used to evaluate the effect of sulforaphane treatment over time on GSVA enrichment score with adjustment for age at study entry, sex, and RIN.|Slope|-0.27|STANDARD_ERROR_OF_MEAN|0.1||0.012|TWO_SIDED|||||Sulforaphane treatment would downregulate the expression of these genes whose upregulated expressions in bronchial epithelial cells have been found to be associated with risk of lung cancer.|Mixed Models Analysis|The model includes treatment, time, time\*treatment, age at study entry, sex, and RIN.|Changes (beta) of gene expression after the 12-month sulforaphane treatment.|||||0.012
72446048|NCT03232138|144407816|EQUIVALENCE|This analysis was focused on the gene set that were found to be downregulated in lung cancer. The objective was to examine if sulforaphane treatment for 12 months had any significant impact on the expression of these lung-cancer associated upregulated genes in nasal brushing samples. A linear mixed model was used to evaluate the effect of sulforaphane treatment over time on GSVA enrichment score with adjustment for age at study entry, sex, and RIN.|Slope|0.38|STANDARD_ERROR_OF_MEAN|0.12||0.0045|TWO_SIDED|||||Hypothesis: Sulforaphane treatment would upregulate the expression of these genes whose downregulated expressions in nasal epithelial cells have been found to be associated with risk of lung cancer.|Mixed Models Analysis||Changes (beta) of gene expression after the 12-month sulforaphane treatment.|||||0.0045
72469789|NCT01575873|144463470|SUPERIORITY||LS Mean Difference|2.9|||<|0.001|TWO_SIDED|95.0|2.0|3.9||2-sided p-value corresponding to the 2-sided 95% confidence interval|ANCOVA||LS Mean Difference = Denosumab - Risedronate|"Analyses of the primary and secondary endpoints were performed independently within each subpopulation using a fixed-sequence testing procedure to control the experiment-wise type 1 error rate at a two-sided 5% significance level.~The glucocorticoid-initiating subpopulation was analyzed using an ANCOVA model adjusting for treatment, baseline BMD value, sex, machine type, and baseline BMD value-by-machine type interaction."||3.9|2.0|< 0.001
72446049|NCT03232138|144407817|EQUIVALENCE|This analysis was focused on the gene set that were found to be upregulated in lung premalignant lesions. The objective was to examine if sulforaphane treatment for 12 months had any significant impact on the expression of these premalignant lesion-associated upregulated genes in nasal brushing samples. A linear mixed model was used to evaluate the effect of sulforaphane treatment over time on GSVA enrichment score with adjustment for age at study entry, sex, and RIN.|Slope|0.17|STANDARD_ERROR_OF_MEAN|0.16||0.32|TWO_SIDED|||||Hypothesis: Sulforaphane treatment would downregulate the expression of these genes whose upregulated expressions in bronchial epithelial cells have been found to be associated with risk of lung premalignant lesions.|Mixed Models Analysis|The model includes treatment, time, time\*treatment, age at study entry, sex, and RIN.|Changes (beta) of gene expression after the 12-month sulforaphane treatment.|||||0.32
72446050|NCT03232138|144407818|EQUIVALENCE|This analysis was focused on the gene set that were found to be downregulated in lung premalignant lesions. The objective was to examine if sulforaphane treatment for 12 months had any significant impact on the expression of these premalignant lesion-associated downregulated genes in nasal brushing samples. A linear mixed model was used to evaluate the effect of sulforaphane treatment over time on GSVA enrichment score with adjustment for age at study entry, sex, and RIN.|Slope|-0.16|STANDARD_ERROR_OF_MEAN|0.14||0.27|TWO_SIDED|||||Hypothesis: Sulforaphane treatment would upregulate the expression of these genes whose downregulated expressions in bronchial epithelial cells have been found to be associated with risk of lung premalignant lesions.|Mixed Models Analysis|The model includes treatment, time, time\*treatment, age at study entry, sex, and RIN.|Changes (beta) of gene expression after the 12-month sulforaphane treatment.|||||0.27
72446051|NCT03232138|144407819|EQUIVALENCE|Total number of adverse events by attrition and severity by treatment group during the study period, The Pittsburgh Clinical Trial of Sulforaphane (SFN) on Risk Markers of Lung Cancer||||||0.59||||||For severity by treatment group.|Fisher Exact|||||||0.590
72446052|NCT03232138|144407819|EQUIVALENCE|Total number of adverse events by attrition and severity by treatment group during the study period, The Pittsburgh Clinical Trial of Sulforaphane (SFN) on Risk Markers of Lung Cancer||||||0.131||||||For attribution by treatment group.|Fisher Exact|||||||0.131
72446053|NCT00999804|144407852|SUPERIORITY_OR_OTHER_LEGACY||proportion of pCR|0.25|||||TWO_SIDED||||||||No comparison is required between the 24 weeks arm and 12 weeks arm. The study is designed as the 24 weeks arm ran as a single arm, using an admissible Simon-like two-stage design and required 20 or more responses in the first 55 evaluable patients.|"The study was planned to enroll 136 patients if the original cohort (n=90) was deemed successful. The 24 weeks arm ran as a single arm, using an admissible Simon-like two-stage design. The 12 weeks arm accrued as long as the 24 weeks arm is open.~The analysis of the first cohort indicated that 15 pCR were observed , which did not meet the required 20 or more responses. The accrual was closed early and the study has a total of 128 participants."||||
72446054|NCT00999804|144407853|SUPERIORITY_OR_OTHER_LEGACY||proportion of patients with AE|0.72|||||TWO_SIDED||||||||61 out of 85 patients (72%) in the 24-week arm had at least 1 adverse events.|This outcome is to establish the safety and tolerability of an extended regimen of lapatinib + trastuzumab, with or without endocrine therapy. No comparison between the 2 arms is required.||||
72446055|NCT00999804|144407854|SUPERIORITY_OR_OTHER_LEGACY||proportion of tpCR in 24 weeks arm|0.1|||||TWO_SIDED|||||||||No comparison between the two arms is required.||||
72446056|NCT00999804|144407855|SUPERIORITY_OR_OTHER_LEGACY||proportion of CR+PR in 24 weeks arm|0.69|||||TWO_SIDED|||||||||No comparison between the 2 arm is required for this study.||||
72446057|NCT05908344|144407862|OTHER|Effect size determination|Cohen's d|-0.24|||||TWO_SIDED|||||||||Comparison for NREM1 minutes. Group Selection refers to study device Condition (Active/Sham); repeated-measures design||||
72446058|NCT05908344|144407862|OTHER|Effect size determination|Cohen's d|-0.15|||||TWO_SIDED|||||||||Comparison for NREM2 minutes. Group Selection refers to study device Condition (Active/Sham); repeated-measures design.||||
72446059|NCT05908344|144407862|OTHER|Effect size determination|Cohen's d|0.69|||||TWO_SIDED|||||||||Comparison for NREM3 minutes. Group Selection refers to study device Condition (Active/Sham); repeated-measures design.||||
72446060|NCT05908344|144407862|OTHER|Effect size determination|Cohen's d|-0.82|||||TWO_SIDED|||||||||Comparison for REM minutes. Group Selection refers to study device Condition (Active/Sham); repeated-measures design.||||
72560871|NCT00706719|144652360|SUPERIORITY_OR_OTHER|||||||0.006|TWO_SIDED||||||t-test, 2 sided|||Comparison of Group A and B observed values at Month 3.||||0.006
72446061|NCT05908344|144407863|OTHER|Effect size determination|Cohen's d|-0.04|||||TWO_SIDED|||||||||Comparison for NREM1 percentage. Group Selection refers to study device Condition (Active/Sham); repeated-measures design.||||
72446062|NCT05908344|144407863|OTHER|Effect size determination|Cohen's d|0.24|||||TWO_SIDED|||||||||Comparison for NREM2 percentage. Group Selection refers to study device Condition (Active/Sham); repeated-measures design.||||
72446063|NCT05908344|144407863|OTHER|Effect size determination|Cohen's d|0.8|||||TWO_SIDED|||||||||Comparison for NREM3 percentage. Group Selection refers to study device Condition (Active/Sham); repeated-measures design.||||
72446064|NCT05908344|144407863|OTHER|Effect size determination|Cohen's d|-0.78|||||TWO_SIDED|||||||||Comparison for REM percentage. Group Selection refers to study device Condition (Active/Sham); repeated-measures design.||||
72446065|NCT05908344|144407864|OTHER|Effect size determination|Cohen's d|0.11|||||TWO_SIDED|||||||||Group Selection refers to study device Condition (Active/Sham); repeated-measures design.||||
72560872|NCT00706719|144652360|SUPERIORITY_OR_OTHER|||||||0.009|TWO_SIDED||||||t-test, 2 sided|||Comparison of Group A and B observed values at Month 6.||||0.009
72560873|NCT00706719|144652360|SUPERIORITY_OR_OTHER|||||||0.0024|TWO_SIDED||||||t-test, 2 sided|||Comparison of Group A and B observed values at Follow-up (Month 7).||||0.0024
72497792|NCT00792298|144525821|SUPERIORITY_OR_OTHER||LS Mean Difference: Week 4|7.6|||<|0.001|TWO_SIDED|95.0|4.4|10.9|||Mixed Models Analysis|||A fixed sequential testing procedure assessed statistical significance, beginning with the highest dose. The comparison of suvorexant vs placebo had to be significant at α=0.05 at both Night 1 and Week 4 in order to assess statistical significance of the comparison of suvorexant vs placebo for the next highest dose. If a non-significant result was observed at either time point, the differences between suvorexant and placebo for SE was considered nonsignificant for this and all lower doses.||10.9|4.4|<0.001
72560874|NCT00706719|144652361|SUPERIORITY_OR_OTHER|||||||0.15|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Comparison of Group A and B observed values at Baseline.||||0.15
72560875|NCT00706719|144652361|SUPERIORITY_OR_OTHER|||||||0.0067|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Comparison of Group A and B observed values at Month 3.||||0.0067
72389834|NCT00332163|144287581|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.0|||||TWO_SIDED|95.0|0.6|1.6|||||Hazard ratio is estimated from a Cox Proportional Hazards regression model with an indicator for treatment (Pre-emptive vs. Reactive) stratified by chemotherapy stratum (Q2W vs Q3W).|||1.6|0.6|
72389835|NCT02621060|144287583|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.05|STANDARD_DEVIATION|2.0||0.004|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||0.004
72446066|NCT06393088|144407935|SUPERIORITY|It was calculated that 24 participants randomized 1:1 between 2 arms would have at least an 85% power to detect a difference in pain relief of 30 points as measured using a Visual Analog Device. The actual difference in the mean of the change in pain level, as measured using a Visual Analog Scale, between the two independent groups is 41.67. Results of the post trial calculation was a 95.7% power to detect the difference in pain relief using 29 randomized participants.|Mean Difference (Net)|41.67|||<|0.01|TWO_SIDED|95.0|20.15|61.67||The threshold is P-value \<.0.05 for statistical significance A bootstrap N=20,000 was used for all estimates|t-test, 2 sided|||"Null Hypothesis:~There is not a statistically significant difference in nociceptive musculoskeletal pain when using an IR REHAB device when compared with a sham (placebo) device as a therapy in an approved and standardized clinical protocol."||61.67|20.15|<0.01
72504786|NCT03114969|144540510|SUPERIORITY||Odds Ratio (OR)|10.215||||0.126|TWO_SIDED|95.0|0.519|200.904||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.|||200.904|0.519|0.126
72504787|NCT03114969|144540510|SUPERIORITY||Odds Ratio (OR)|13.717||||0.082|TWO_SIDED|95.0|0.715|263.125||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.|||263.125|0.715|0.082
72560876|NCT00706719|144652361|SUPERIORITY_OR_OTHER|||||||0.1|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Comparison of Group A and B observed values at Month 6.||||0.10
72389836|NCT02621060|144287584|SUPERIORITY_OR_OTHER|||||||0.084|||||||Wilcoxon (Mann-Whitney)|||||||0.084
72389837|NCT02621060|144287585|SUPERIORITY_OR_OTHER|||||||0.755|||||||Wilcoxon (Mann-Whitney)|||||||0.755
72389838|NCT02621060|144287586|SUPERIORITY_OR_OTHER|||||||0.03|||||||Wilcoxon (Mann-Whitney)|||||||0.03
72389839|NCT02621060|144287587|SUPERIORITY_OR_OTHER|||||||0.084|||||||Wilcoxon (Mann-Whitney)|||||||0.084
72389840|NCT02621060|144287588|SUPERIORITY_OR_OTHER|||||||0.004|||||||Wilcoxon (Mann-Whitney)|||||||0.004
72389841|NCT02621060|144287590|SUPERIORITY_OR_OTHER|||||||0.074|||||||Wilcoxon (Mann-Whitney)|||||||0.074
72389842|NCT02621060|144287591|SUPERIORITY_OR_OTHER|||||||0.022|||||||Wilcoxon (Mann-Whitney)|||||||0.022
72389843|NCT02621060|144287592|SUPERIORITY||Mean Difference (Final Values)|0.05||||0.022|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||0.022
72389844|NCT02621060|144287593|SUPERIORITY||Mean Difference (Final Values)|0.05||||0.022|TWO_SIDED|5.0|||||Wilcoxon (Mann-Whitney)|||||||0.022
72389845|NCT02621060|144287594|SUPERIORITY_OR_OTHER|||||||0.594|||||||Wilcoxon (Mann-Whitney)|||||||0.594
72389846|NCT02621060|144287595|SUPERIORITY_OR_OTHER|||||||0.42|||||||Wilcoxon (Mann-Whitney)|||||||0.42
72389847|NCT02621060|144287596|SUPERIORITY_OR_OTHER|||||||0.002|||||||Wilcoxon (Mann-Whitney)|||||||0.002
72389848|NCT02621060|144287597|SUPERIORITY_OR_OTHER|||||||0.002|||||||Wilcoxon (Mann-Whitney)|||||||0.002
72389849|NCT02621060|144287598|SUPERIORITY_OR_OTHER|||||||0.059|||||||Wilcoxon (Mann-Whitney)|||||||0.059
72389850|NCT02621060|144287599|SUPERIORITY_OR_OTHER|||||||0.049|||||||Wilcoxon (Mann-Whitney)|||||||0.049
72389851|NCT02621060|144287600|SUPERIORITY_OR_OTHER|||||||0.002|||||||Wilcoxon (Mann-Whitney)|||||||0.002
72389852|NCT02621060|144287601|SUPERIORITY_OR_OTHER|||||||0.376|||||||Wilcoxon (Mann-Whitney)|||||||0.376
72389853|NCT02621060|144287602|SUPERIORITY_OR_OTHER|||||||0.472|||||||Wilcoxon (Mann-Whitney)|||||||0.472
72389854|NCT02621060|144287603|SUPERIORITY_OR_OTHER|||||||0.774|||||||Wilcoxon (Mann-Whitney)|||||||0.774
72389855|NCT02621060|144287604|SUPERIORITY_OR_OTHER|||||||0.637|||||||Wilcoxon (Mann-Whitney)|||||||0.637
72389856|NCT03733470|144287605|OTHER||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
72389857|NCT01010061|144287606|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.21|||<|0.0001|TWO_SIDED|95.0|0.16|0.28||Type I error controlled through closed test procedure.|Log Rank, Stratified||Stratified by Binet stage at Baseline.|||0.28|0.16|<0.0001
72389858|NCT01010061|144287608|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.19|||<|0.0001|TWO_SIDED|95.0|0.14|0.27|||Log Rank, Stratified||Stratified by Binet stage at Baseline.|||0.27|0.14|<0.0001
72389859|NCT01010061|144287611|SUPERIORITY||Difference in Response Rates|45.1|||<|0.0001|TWO_SIDED|95.0|34.7|55.5|||Chi-squared|||Includes subjects with best overall response: CR, CRi, PR or nPR.||55.5|34.7|< 0.0001
72389860|NCT01010061|144287612|SUPERIORITY||Hazard Ratio (HR)|0.19|||<|0.0001|TWO_SIDED|95.0|0.15|0.26|||Log Rank, Stratified||Stratified by Binet stage at Baseline.|||0.26|0.15|<0.0001
72389861|NCT01010061|144287613|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.68||||0.0196|TWO_SIDED|95.0|0.49|0.94|||Log Rank, Stratified|||||0.94|0.49|0.0196
72389862|NCT01010061|144287614|SUPERIORITY_OR_OTHER||Hazard Ratio (stratified)|0.19|||<|0.0001|TWO_SIDED|95.0|0.13|0.28|||Log Rank, Stratified|Stratified by Binet stage at Baseline.||||0.28|0.13|<0.0001
72389863|NCT01010061|144287616|SUPERIORITY_OR_OTHER||Hazard Ratio (stratified)|0.25|||<|0.0001|TWO_SIDED|95.0|0.19|0.35|||Log Rank, Stratified|Stratified by Binet stage at Baseline.||||0.35|0.19|<0.0001
72389864|NCT03470441|144287620|OTHER||||||||||||||descriptive||||As little data exists on the incidence of arrhythmias that occur over an extended period of time following AMI, descriptive analysis of the primary endpoints (Arrhythmias of Interest at 48 hours and 14 days for overall and anterior infarcts) was appropriate in this study due to the absence of an externally validated benchmark which would normally serve as the basis for hypothesis testing of FDY-5301's effect on arrhythmias.|||
72389865|NCT03470441|144287625|SUPERIORITY||Median Difference (Final Values)|-3.2||||0.32|TWO_SIDED|95.15|-10.8|3.1|||Wilcoxon (Mann-Whitney)|||Wilcoxon Mann-Whitney Test comparing placebo to FDY-5301 treated subjects (combined low dose, intermediate dose, and high dose).||3.1|-10.8|0.32
72560877|NCT00706719|144652361|SUPERIORITY_OR_OTHER|||||||0.26|TWO_SIDED||||||t-test, 2 sided|||Comparison of Group A and B observed values at Follow-up (Month 7).||||0.26
72446067|NCT04176965|144407936|NON_INFERIORITY|Non-inferiority based on the observed 95% Upper Confidence Limit of the difference in means between the 2 groups (FINEVISION HP - AcrySof SN60AT). Non-inferiority margin = 0.10 logMAR.|Mean difference|0.045|STANDARD_ERROR_OF_MEAN|0.0084|<|0.0001|TWO_SIDED|90.0|0.0316|0.0592|||t-test, 1 sided|||||0.0592|0.0316|<0.0001
72446068|NCT04176965|144407937|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
72446069|NCT04176965|144407938|NON_INFERIORITY|Noninferiority of FINEVISION HP compared to control in percentages of first operative eyes with secondary surgical interventions related to the optical properties of the IOL was evaluated using two-sided 90% Farrington method confidence intervals around the difference in percentages between the 2 groups. If the upper limit of the confidence interval is less than 1.4%, the FINEVISION HP IOL will be considered statistically non-inferior to the control IOL.|Difference in percentages|0.3|||||TWO_SIDED|90.0|-0.76|1.36||||||||1.36|-0.76|
72446070|NCT04176965|144407943|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
72446071|NCT04176965|144407944|NON_INFERIORITY|Cumulative: Cystoid macular oedema. The observed AE rates in the FINEVISION HP group were compared to the SPE rates from ISO 11979-7 Table E.2. A p value of \>0.05 indicates that the rates were statistically not significant when compared to SPE rates.|||||>|0.05|||||||One-sided exact binomial test|||||||>0.05
72446072|NCT04176965|144407944|NON_INFERIORITY|Cumulative: Cystoid macular oedema. The observed AE rates in the control group were compared to the SPE rates from ISO 11979-7 Table E.2. A p value of \>0.05 indicates that the rates were statistically not significant when compared to SPE rates.|||||>|0.05|||||||One-sided exact binomial test|||||||>0.05
72446073|NCT04176965|144407944|NON_INFERIORITY|Cumulative: Hypopyon. The observed AE rates in the FINEVISION HP group were compared to the SPE rates from ISO 11979-7 Table E.2. A p value of \>0.05 indicates that the rates were statistically not significant when compared to SPE rates.|||||>|0.05|||||||One-sided exact binomial test|||||||>0.05
72446074|NCT04176965|144407944|NON_INFERIORITY|Cumulative: Hypopyon. The observed AE rates in the control group were compared to the SPE rates from ISO 11979-7 Table E.2. A p value of \>0.05 indicates that the rates were statistically not significant when compared to SPE rates.|||||>|0.05|||||||One-sided exact binomial test|||||||>0.05
72446075|NCT04176965|144407944|NON_INFERIORITY|Cumulative: Endophthalmitis. The observed AE rates in the FINEVISION HP group were compared to the SPE rates from ISO 11979-7 Table E.2. A p value of \>0.05 indicates that the rates were statistically not significant when compared to SPE rates.|||||>|0.05|||||||One-sided exact binomial test|||||||>0.05
72497793|NCT00792298|144525821|SUPERIORITY_OR_OTHER||LS Mean Difference: Night 1|10.8|||<|0.001|TWO_SIDED|95.0|7.4|14.2|||Mixed Models Analysis|||A fixed sequential testing procedure assessed statistical significance, beginning with the highest dose. The comparison of suvorexant vs placebo had to be significant at α=0.05 at both Night 1 and Week 4 in order to assess statistical significance of the comparison of suvorexant vs placebo for the next highest dose. If a non-significant result was observed at either time point, the differences between suvorexant and placebo for SE was considered nonsignificant for this and all lower doses.||14.2|7.4|<0.001
72446076|NCT04176965|144407944|NON_INFERIORITY|Cumulative: Endophthalmitis. The observed AE rates in the control group were compared to the SPE rates from ISO 11979-7 Table E.2. A p value of \>0.05 indicates that the rates were statistically not significant when compared to SPE rates.|||||>|0.05|||||||One-sided exact binomial test|||||||>0.05
72446077|NCT04176965|144407944|NON_INFERIORITY|Cumulative: Lens dislocated from posterior chamber. The observed AE rates in the FINEVISION HP group were compared to the SPE rates from ISO 11979-7 Table E.2. A p value of \>0.05 indicates that the rates were statistically not significant when compared to SPE rates.|||||>|0.05|||||||One-sided exact binomial test|||||||>0.05
72446078|NCT04176965|144407944|NON_INFERIORITY|Cumulative: Lens dislocated from posterior chamber. The observed AE rates in the control group were compared to the SPE rates from ISO 11979-7 Table E.2. A p value of \>0.05 indicates that the rates were statistically not significant when compared to SPE rates.|||||>|0.05|||||||One-sided exact binomial test|||||||>0.05
72446079|NCT04176965|144407944|NON_INFERIORITY|Cumulative: Pupillary block.The observed AE rates in the FINEVISION HP group were compared to the SPE rates from ISO 11979-7 Table E.2. A p value of \>0.05 indicates that the rates were statistically not significant when compared to SPE rates.|||||>|0.05|||||||One-sided exact binomial test|||||||>0.05
72446080|NCT04176965|144407944|NON_INFERIORITY|Cumulative: Pupillary block.The observed AE rates in the control group were compared to the SPE rates from ISO 11979-7 Table E.2. A p value of \>0.05 indicates that the rates were statistically not significant when compared to SPE rates.|||||>|0.05|||||||One-sided exact binomial test|||||||>0.05
72446081|NCT04176965|144407944|NON_INFERIORITY|Cumulative: Retinal detachment.The observed AE rates in the FINEVISION HP group were compared to the SPE rates from ISO 11979-7 Table E.2. A p value of \>0.05 indicates that the rates were statistically not significant when compared to SPE rates.|||||>|0.05|||||||One-sided exact binomial test|||||||>0.05
72446082|NCT04176965|144407944|NON_INFERIORITY|Cumulative: Retinal detachment.The observed AE rates in the control group were compared to the SPE rates from ISO 11979-7 Table E.2. A p value of \>0.05 indicates that the rates were statistically not significant when compared to SPE rates.|||||>|0.05|||||||One-sided exact binomial test|||||||>0.05
72560878|NCT00706719|144652362|SUPERIORITY_OR_OTHER|||||||0.88|TWO_SIDED||||||t-test, 2 sided|||Comparison of Group A and B observed values at Baseline.||||0.880
72560879|NCT00706719|144652362|SUPERIORITY_OR_OTHER|||||||0.612|TWO_SIDED||||||t-test, 2 sided|||Comparison of Group A and B observed values at Month 3.||||0.612
72560880|NCT00706719|144652362|SUPERIORITY_OR_OTHER|||||||0.488|TWO_SIDED||||||t-test, 2 sided|||Comparison of Group A and B observed values at Month 6.||||0.488
72446083|NCT04176965|144407944|NON_INFERIORITY|Cumulative: Secondary surgical intervention.The observed AE rates in the FINEVISION HP group were compared to the SPE rates from ISO 11979-7 Table E.2. A p value of \>0.05 indicates that the rates were statistically not significant when compared to SPE rates.|||||>|0.05|||||||One-sided exact binomial test|||||||>0.05
72446084|NCT04176965|144407944|NON_INFERIORITY|Cumulative: Secondary surgical intervention.The observed AE rates in the control group were compared to the SPE rates from ISO 11979-7 Table E.2. A p value of \>0.05 indicates that the rates were statistically not significant when compared to SPE rates.|||||>|0.05|||||||One-sided exact binomial test|||||||>0.05
72389866|NCT03470441|144287627|SUPERIORITY||Median Difference (Final Values)|-4.4||||0.46|TWO_SIDED|95.16|-20.2|12.1|||Wilcoxon (Mann-Whitney)|||Wilcoxon Mann-Whitney Test Comparing placebo to anterior infarcts FDY-5301 treated subjects (low, intermediate, and high) combined into one group.||12.10|-20.2|0.46
72446085|NCT04176965|144407944|NON_INFERIORITY|Persistent: Corneal stroma oedema.The observed AE rates in the FINEVISION HP group were compared to the SPE rates from ISO 11979-7 Table E.2. A p value of \>0.05 indicates that the rates were statistically not significant when compared to SPE rates.|||||>|0.05|||||||One-sided exact binomial test|||||||>0.05
72446086|NCT04176965|144407944|NON_INFERIORITY|Persistent: Corneal stroma oedema.The observed AE rates in the control group were compared to the SPE rates from ISO 11979-7 Table E.2. A p value of \>0.05 indicates that the rates were statistically not significant when compared to SPE rates.|||||>|0.05|||||||One-sided exact binomial test|||||||>0.05
72446087|NCT04176965|144407944|NON_INFERIORITY|Persistent: Cystoid macular oedema.The observed AE rates in the FINEVISION HP group were compared to the SPE rates from ISO 11979-7 Table E.2. A p value of \>0.05 indicates that the rates were statistically not significant when compared to SPE rates.|||||>|0.05|||||||One-sided exact binomial test|||||||>0.05
72446088|NCT04176965|144407944|NON_INFERIORITY|Persistent: Cystoid macular oedema.The observed AE rates in the control group were compared to the SPE rates from ISO 11979-7 Table E.2. A p value of \>0.05 indicates that the rates were statistically not significant when compared to SPE rates.|||||>|0.05|||||||One-sided exact binomial test|||||||>0.05
72560881|NCT00706719|144652362|SUPERIORITY_OR_OTHER|||||||0.054|TWO_SIDED||||||t-test, 2 sided|||Comparison of Group A and B observed values at Follow-up (Month 7).||||0.054
72560882|NCT00706719|144652363|SUPERIORITY_OR_OTHER|||||||0.705|TWO_SIDED||||||t-test, 2 sided|||Comparison of Group A and B observed values at Baseline.||||0.705
72389867|NCT03470441|144287633|SUPERIORITY||Median Difference (Final Values)|3.7||||0.25|TWO_SIDED|95.11|-3.6|10.6|||Wilcoxon (Mann-Whitney)|||Wilcoxon Mann-Whitney Test comparing placebo to FDY-5301 treated subjects (combined low dose, intermediate dose, and high dose).||10.6|-3.6|0.25
72389868|NCT03470441|144287635|SUPERIORITY||Median Difference (Final Values)|4.9||||0.31|TWO_SIDED|95.16|-7.0|16.9|||Wilcoxon (Mann-Whitney)|||Wilcoxon Mann-Whitney Test comparing placebo to anterior infarcts FDY-5301 treated subjects (combined low dose, intermediate dose, and high dose).||16.9|-7|0.31
72389869|NCT01146834|144287679|SUPERIORITY||Risk Difference (RD)|-0.02||||0.9|TWO_SIDED|95.0|-0.32|0.28|||Chi-squared|||Arm B was initially closed due to low accrual, and Arms D and E were also closed due to no accrual. Arms A and C also had very low accrual. Therefore, the comparison of the primary outcome between Arms A and C is for exploratory purposes only.||0.28|-0.32|0.90
72389870|NCT01146834|144287681|SUPERIORITY||Risk Difference (RD)|-0.25||||0.25|TWO_SIDED|95.0|-0.68|0.18|||Fisher Exact|||||0.18|-0.68|0.25
72389871|NCT00282984|144287682|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.05|||<|0.0001||95.0|4.13|8.86||To preserve type I family-wise error rate of 0.05, used step-down procedure to analyze primary \& 2 key secondary endpoints. Hierarchy of comparisons: 1) 4-week CQR for Weeks 9 thru 12, 2) CA at Week 52, 3) the Long Term Quit Rate (LTQR) thru Week 52.|Regression, Logistic|Logistic regression model fitted to primary endpoint \& key secondary endpoints; included main effects of trtmt group and center as independent var.||Estimates for expected \& clinically meaningful var \& pbo 4-week CQR for Week 9 - 12 of trtmt based on response rates \& corresponding 95% OR confidence interval (CI) from A30510285 \& A30510366 study results. Total n=700 randomized var or pbo 1:1 should have provided at least 99% power to detect difference in primary endpoint (endpt) between (b/w) var \& pbo, assuming true 4-week CQR of 0.18 for pbo \& 0.40 for var (OR of at least 3.04), and 84% power for 2 key secondary endpts.||8.86|4.13|<0.0001
72395182|NCT03918447|144296979|SUPERIORITY||Least Square Means Difference|7.94|STANDARD_ERROR_OF_MEAN|0.777|<|0.0001|TWO_SIDED|95.0|6.41|9.47|||MMRM|||Mixed model repeated measure (MMRM) model used baseline eGFR as a covariate, and the following fixed factors: treatment group, time (Week 1 to 100, excluding Week 52), and the interaction between treatment and time. Within-participant errors are modeled using an unstructured covariance matrix.||9.47|6.41|<0.0001
72395183|NCT01405456|144297036|SUPERIORITY|||||||0.71|||||||Wilcoxon (Mann-Whitney)|||Change in Insulin Stimulated Glucose Uptake measured during euglycemic hyperinsulinemic clamp procedure from baseline to 6 months||||0.71
72446089|NCT04176965|144407944|NON_INFERIORITY|Persistent: Iritis.The observed AE rates in the FINEVISION HP group were compared to the SPE rates from ISO 11979-7 Table E.2. A p value of \>0.05 indicates that the rates were statistically not significant when compared to SPE rates.|||||>|0.05|||||||One-sided exact binomial test|||||||>0.05
72446090|NCT04176965|144407944|NON_INFERIORITY|Persistent: Iritis.The observed AE rates in the control group were compared to the SPE rates from ISO 11979-7 Table E.2. A p value of \>0.05 indicates that the rates were statistically not significant when compared to SPE rates.|||||>|0.05|||||||One-sided exact binomial test|||||||>0.05
72446091|NCT04176965|144407944|NON_INFERIORITY|Persistent: Raised Intraocular Pressure (IOP) requiring treatment.The observed AE rates in the FINEVISION HP group were compared to the SPE rates from ISO 11979-7 Table E.2. A p value of \>0.05 indicates that the rates were statistically not significant when compared to SPE rates.|||||>|0.05|||||||One-sided exact binomial test|||||||>0.05
72446092|NCT04176965|144407944|NON_INFERIORITY|Persistent: Raised Intraocular Pressure (IOP) requiring treatment.The observed AE rates in the control group were compared to the SPE rates from ISO 11979-7 Table E.2. A p value of \>0.05 indicates that the rates were statistically not significant when compared to SPE rates.|||||>|0.05|||||||One-sided exact binomial test|||||||>0.05
72446093|NCT04072380|144407960|SUPERIORITY|||||||0.024||||||Threshold for statistical significance was p≤0.05|Mixed Models Analysis|Mixed model for repeated measures (MMRM)||||||0.024
72446094|NCT04072380|144407961|SUPERIORITY|||||||0.009||||||Threshold for statistical significance was p≤0.05|Mixed Models Analysis|Mixed model for repeated measures (MMRM)||||||0.009
72446095|NCT04072380|144407962|SUPERIORITY|||||||0.734||||||Threshold for statistical significance was p≤0.05|Mixed Models Analysis|Mixed model for repeated measures (MMRM)||||||0.734
72446096|NCT04072380|144407963|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
72560883|NCT00706719|144652363|SUPERIORITY_OR_OTHER|||||||0.013|TWO_SIDED||||||t-test, 2 sided|||Comparison of Group A and B observed values at Month 3.||||0.013
72560884|NCT00706719|144652363|SUPERIORITY_OR_OTHER|||||||0.004|TWO_SIDED||||||t-test, 2 sided|||Comparison of Group A and B observed values at Month 6.||||0.004
72446097|NCT04072380|144407964|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||||||<0.0001
72446098|NCT03033576|144407970|SUPERIORITY||Hazard Ratio (HR)|0.63||||0.04|TWO_SIDED|90.0|0.41|0.97||Pre-specified one-sided alpha=0.1|Log Rank|||The statistical design assumed exponential PFS with a median of 3.0 months on the ipilimumab group (null hypothesis). The study was powered to detect a change in median PFS to 6.0 months in the combination therapy group (corresponding to an HR of 0.50). A total of 84 participants (63 randomized to combination group and 21 to ipilimumab group) with 78 events (across both groups) would provide 89% power for a one-sided alpha of 10% using a log-rank test.||0.97|0.41|0.04
72446099|NCT03033576|144407973|SUPERIORITY||Hazard Ratio (HR)|0.83||||0.28|TWO_SIDED|90.0|0.5|1.39|||Log Rank|||||1.39|0.50|0.28
72446100|NCT05026320|144408030|EQUIVALENCE|The primary efficacy hypothesis to be tested was the equality of tenderness (algometry) over the initial 72 hours (algometry AUC 0-72).||||||0.0221|||||||ANCOVA|||||||0.0221
72497794|NCT00792298|144525821|SUPERIORITY_OR_OTHER||LS Mean Difference: Week 4|7.8|||<|0.001|TWO_SIDED|95.0|4.6|10.9|||Mixed Models Analysis|||A fixed sequential testing procedure assessed statistical significance, beginning with the highest dose. The comparison of suvorexant vs placebo had to be significant at α=0.05 at both Night 1 and Week 4 in order to assess statistical significance of the comparison of suvorexant vs placebo for the next highest dose. If a non-significant result was observed at either time point, the differences between suvorexant and placebo for SE was considered nonsignificant for this and all lower doses.||10.9|4.6|<0.001
72497795|NCT00792298|144525821|SUPERIORITY_OR_OTHER||LS Mean Difference: Night 1|7.6|||<|0.001|TWO_SIDED|95.0|4.2|11.0|||Mixed Models Analysis|||A fixed sequential testing procedure assessed statistical significance, beginning with the highest dose. The comparison of suvorexant vs placebo had to be significant at α=0.05 at both Night 1 and Week 4 in order to assess statistical significance of the comparison of suvorexant vs placebo for the next highest dose. If a non-significant result was observed at either time point, the differences between suvorexant and placebo for SE was considered nonsignificant for this and all lower doses.||11.0|4.2|<0.001
72497796|NCT00792298|144525821|SUPERIORITY_OR_OTHER||LS Mean Difference: Week 4|10.4|||<|0.001|TWO_SIDED|95.0|7.2|13.6|||Mixed Models Analysis|||A fixed sequential testing procedure assessed statistical significance, beginning with the highest dose. The comparison of suvorexant vs placebo had to be significant at α=0.05 at both Night 1 and Week 4 in order to assess statistical significance of the comparison of suvorexant vs placebo for the next highest dose. If a non-significant result was observed at either time point, the differences between suvorexant and placebo for SE was considered nonsignificant for this and all lower doses.||13.6|7.2|<0.001
72497797|NCT00792298|144525821|SUPERIORITY_OR_OTHER||LS Mean Difference: Night 1|5.2||||0.002|TWO_SIDED|95.0|1.9|8.6|||Mixed Models Analysis|||A fixed sequential testing procedure assessed statistical significance, beginning with the highest dose. The comparison of suvorexant vs placebo had to be significant at α=0.05 at both Night 1 and Week 4 in order to assess statistical significance of the comparison of suvorexant vs placebo for the next highest dose. If a non-significant result was observed at either time point, the differences between suvorexant and placebo for SE was considered nonsignificant for this and all lower doses.||8.6|1.9|0.002
72497798|NCT00792298|144525821|SUPERIORITY_OR_OTHER||LS Mean Difference: Week 4|4.7||||0.003|TWO_SIDED|95.0|1.6|7.8|||Mixed Models Analysis|||A fixed sequential testing procedure assessed statistical significance, beginning with the highest dose. The comparison of suvorexant vs placebo had to be significant at α=0.05 at both Night 1 and Week 4 in order to assess statistical significance of the comparison of suvorexant vs placebo for the next highest dose. If a non-significant result was observed at either time point, the differences between suvorexant and placebo for SE was considered nonsignificant for this and all lower doses.||7.8|1.6|0.003
72497799|NCT00792298|144525822|SUPERIORITY_OR_OTHER||LS Mean Difference: Night 1|-36.8|||<|0.001|TWO_SIDED|95.0|-49.4|-24.3|||Mixed Models Analysis|||A fixed sequential testing procedure assessed statistical significance, beginning with the highest dose. The comparison of suvorexant vs placebo had to be significant at α=0.05 at both Night 1 and Week 4 in order to assess statistical significance of the comparison of suvorexant vs placebo for the next highest dose. If a non-significant result was observed at either time point, the differences between suvorexant and placebo for SE was considered nonsignificant for this and all lower doses.||-24.3|-49.4|<0.001
72560885|NCT00706719|144652363|SUPERIORITY_OR_OTHER|||||||0.808|TWO_SIDED||||||t-test, 2 sided|||Comparison of Group A and B observed values at Follow-up (Month 7).||||0.808
72560886|NCT00706719|144652364|SUPERIORITY_OR_OTHER|||||||0.008|TWO_SIDED||||||t-test, 2 sided|||Comparison of Group A and B observed values at Baseline.||||0.008
72560887|NCT00706719|144652364|SUPERIORITY_OR_OTHER|||||||0.015|TWO_SIDED||||||t-test, 2 sided|||Comparison of Group A and B observed values at Month 3.||||0.015
72560888|NCT00706719|144652364|SUPERIORITY_OR_OTHER|||||||0.003|TWO_SIDED||||||t-test, 2 sided|||Comparison of Group A and B observed values at Month 6.||||0.003
72619333|NCT03142451|144769287|SUPERIORITY||Mean Difference (Final Values)|2.63|STANDARD_ERROR_OF_MEAN|0.747||0.0004|TWO_SIDED|95.0|1.16|4.09|||ANCOVA|ANCOVA model included treatment, Baseline inflammatory lesion count, and analysis center.||Statistical analysis for Week 4||4.09|1.16|0.0004
72560889|NCT00706719|144652364|SUPERIORITY_OR_OTHER|||||||0.109|TWO_SIDED||||||t-test, 2 sided|||Comparison of Group A and B observed values at Follow-up (Month 7).||||0.109
72619334|NCT03142451|144769287|SUPERIORITY||Mean Difference (Final Values)|3.09|STANDARD_ERROR_OF_MEAN|0.75|<|0.0001|TWO_SIDED|95.0|1.62|4.56|||ANCOVA|ANCOVA model included treatment, Baseline inflammatory lesion count, and analysis center.||Statistical analysis for Week 8||4.56|1.62|<0.0001
72446101|NCT05478499|144408033|SUPERIORITY||Odds Ratio (OR)|6.2|||<|0.0001|TWO_SIDED|95.0|2.5|15.3|||Cochran-Mantel-Haenszel||Cochran-Mantel-Haenszel|Full Analysis Set||15.3|2.5|<0.0001
72446102|NCT05478499|144408033|SUPERIORITY||Odds Ratio (OR)|7.0|||<|0.0001|TWO_SIDED|95.0|2.7|18.4|||Cochran-Mantel-Haenszel||Cochran-Mantel-Haenszel|Patient sub-population (s-PGA ≥ 3)||18.4|2.7|<0.0001
72446103|NCT05478499|144408034|SUPERIORITY||Odds Ratio (OR)|40.2|||<|0.0001||95.0|4.6|352.0|||Cochran-Mantel-Haenszel||Cochran-Mantel-Haenszel|Full Analysis Set||352.0|4.6|<0.0001
72446104|NCT05478499|144408034|SUPERIORITY||Odds Ratio (OR)|37.3|||<|0.0001|TWO_SIDED|95.0|4.4|317.6|||Cochran-Mantel-Haenszel||Cochran-Mantel-Haenszel|Patient sub-population (s-PGA ≥ 3)||317.6|4.4|<0.0001
72446105|NCT05478499|144408035|SUPERIORITY||Adjusted mean difference|-2.5|STANDARD_ERROR_OF_MEAN|0.42|<|0.0001||95.0|-3.3|-1.6|||analysis of covariance model||analysis of covariance model|Full Analysis Set||-1.6|-3.3|<0.0001
72619335|NCT03142451|144769288|SUPERIORITY||Risk Ratio (RR)|1.685||||0.0201|TWO_SIDED|95.0|1.085|2.616||P-value is for the null hypothesis that the risk ratio equals 1.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by analysis center.||Statistical analysis for Week 4||2.616|1.085|0.0201
72446106|NCT05478499|144408035|SUPERIORITY||Adjusted mean difference|-2.4|STANDARD_ERROR_OF_MEAN|0.44|<|0.0001|TWO_SIDED|95.0|-3.3|-1.5|||analysis of covariance model||analysis of covariance model|Patient sub-population (s-PGA ≥ 3)||-1.5|-3.3|<0.0001
72446107|NCT05478499|144408036|SUPERIORITY||Odds Ratio (OR)|23.9|||<|0.0001|TWO_SIDED|95.0|5.4|105.6|||Cochran-Mantel-Haenszel||Cochran-Mantel-Haenszel|||105.6|5.4|<0.0001
72446108|NCT02962895|144408042|SUPERIORITY||Least Squares Mean Difference|0.75||||0.5161|TWO_SIDED|95.0|-1.52|3.02|||Mixed Models Analysis|Confidence intervals and p-values derived from a mixed model for repeated measures (MMRM)||Week 24: VAY736 5 mg vs. Placebo||3.02|-1.52|0.5161
72446109|NCT02962895|144408042|SUPERIORITY||Least Squares Mean Difference|-0.55||||0.6332|TWO_SIDED|95.0|-2.8|1.71|||Mixed Models Analysis|Confidence intervals and p-values derived from a mixed model for repeated measures (MMRM)||Week 24: VAY736 50 mg vs. Placebo||1.71|-2.80|0.6332
72446110|NCT02962895|144408042|SUPERIORITY||Least Squares Mean Difference|-1.92||||0.0921|TWO_SIDED|95.0|-4.15|0.32|||Mixed Models Analysis|Confidence intervals and p-values derived from a mixed model for repeated measures (MMRM)||Week 24: VAY736 300 mg vs. Placebo||0.32|-4.15|0.0921
72446111|NCT02962895|144408044|SUPERIORITY||Least Squares Mean Difference|0.32||||0.4457|TWO_SIDED|95.0|-0.5|1.13|||Mixed Models Analysis|Confidence intervals and p-values derived from a mixed model for repeated measures (MMRM)||Week 24: VAY736 5 mg vs. Placebo||1.13|-0.50|0.4457
72446112|NCT02962895|144408044|SUPERIORITY||Least Square Mean Difference|0.01||||0.301|TWO_SIDED|95.0|-0.79|0.82|||Mixed Models Analysis|Confidence intervals and p-values derived from a mixed model for repeated measures (MMRM)||Week 24: VAY736 50 mg vs. Placebo||0.82|-0.79|0.301
72446113|NCT02962895|144408044|SUPERIORITY||Least Square Mean Difference|-0.06||||0.8858|TWO_SIDED|95.0|-0.86|0.74|||Mixed Models Analysis|Confidence intervals and p-values derived from a mixed model for repeated measures (MMRM)||Week 24: VAY736 300 mg vs. Placebo||0.74|-0.86|0.8858
72446114|NCT02962895|144408046|SUPERIORITY||Least Squares Mean Difference|-1.93||||0.3424|TWO_SIDED|95.0|-5.93|2.07|||Mixed Models Analysis|Confidence intervals and p-values are derived from a mixed model for repeated measures (MMRM)||Week 24: VAY736 5 mg vs. Placebo||2.07|-5.93|0.3424
72446115|NCT02962895|144408046|SUPERIORITY||Least Squares Mean Difference|-2.56||||0.2092|TWO_SIDED|95.0|-6.58|1.45|||Mixed Models Analysis|Confidence intervals and p-values are derived from a mixed model for repeated measures (MMRM)||Week 24: VAY736 50 mg vs. Placebo||1.45|-6.58|0.2092
72446116|NCT02962895|144408046|SUPERIORITY||Least Squares Mean Difference|0.31||||0.874|TWO_SIDED|95.0|-3.58|4.2|||Mixed Models Analysis|Confidence intervals and p-values are derived from a mixed model for repeated measures (MMRM)||Week 24: VAY736 300 mg vs. Placebo||4.20|-3.58|0.8740
72446117|NCT02962895|144408048|SUPERIORITY||Least Squares Mean Difference|-1.02||||0.5768|TWO_SIDED|95.0|-4.61|2.57|||Mixed Models Analysis|Confidence intervals and p-values derived from a mixed model for repeated measures (MMRM)||Week 24: VAY736 5 mg vs. Placebo / Mental Component Score||2.57|-4.61|0.5768
72446118|NCT02962895|144408048|SUPERIORITY||Least Squares Mean Difference|0.68||||0.7113|TWO_SIDED|95.0|-2.93|4.28|||Mixed Models Analysis|Confidence intervals and p-values derived from a mixed model for repeated measures (MMRM)||Week 24: VAY736 50 mg vs. Placebo / Mental Component Score||4.28|-2.93|0.7113
72446119|NCT02962895|144408048|SUPERIORITY||Least Squares Mean Difference|1.0||||0.5722|TWO_SIDED|95.0|-2.49|4.48|||Mixed Models Analysis|Confidence intervals and p-values derived from a mixed model for repeated measures (MMRM)||Week 24: VAY736 300 mg vs. Placebo / Mental Component Score||4.48|-2.49|0.5722
72446120|NCT02962895|144408048|SUPERIORITY||Least Squares Mean Difference|1.84||||0.4138|TWO_SIDED|95.0|-1.59|3.83|||Mixed Models Analysis|Confidence intervals and p-values derived from a mixed model for repeated measures (MMRM)||Week 24: VAY736 5 mg vs. Placebo / Physical Component Score||3.83|-1.59|0.4138
72446121|NCT02962895|144408048|SUPERIORITY||Least Squares Mean Difference|-1.0||||0.4663|TWO_SIDED|95.0|-3.72|1.71|||Mixed Models Analysis|Confidence intervals and p-values derived from a mixed model for repeated measures (MMRM)||Week 24: VAY736 50 mg vs. Placebo / Physical Component Score||1.71|-3.72|0.4663
72446122|NCT02962895|144408048|SUPERIORITY||Least Squares Mean Difference|1.84||||0.1694|TWO_SIDED|95.0|-0.79|4.47|||Mixed Models Analysis|Confidence intervals and p-values derived from a mixed model for repeated measures (MMRM)||Week 24: VAY736 300 mg vs. Placebo / Physical Component Score||4.47|-0.79|0.1694
72446123|NCT02962895|144408050|SUPERIORITY||Least Squares Mean Difference|-4.17||||0.2671|TWO_SIDED|95.0|-11.56|3.22|||Mixed Models Analysis|Confidence intervals and p-values derived from a mixed model for repeated measures (MMRM)||Week 24: VAY736 5 mg vs. Placebo||3.22|-11.56|0.2671
72446124|NCT02962895|144408050|SUPERIORITY||Least Squares Mean Difference|-4.49||||0.2248|TWO_SIDED|95.0|-11.78|2.79|||Mixed Models Analysis|Confidence intervals and p-values derived from a mixed model for repeated measures (MMRM)||Week 24: VAY736 50 mg vs. Placebo||2.79|-11.78|0.2248
72446125|NCT02962895|144408050|SUPERIORITY||Least Squares Mean Difference|-8.36||||0.0224|TWO_SIDED|95.0|-15.51|-1.2|||Mixed Models Analysis|Confidence intervals and p-values derived from a mixed model for repeated measures (MMRM)||Week 24: VAY736 300 mg vs. Placebo||-1.20|-15.51|0.0224
72446126|NCT02962895|144408052|SUPERIORITY||Least Squares Mean Difference|2.27||||0.6457|TWO_SIDED|95.0|-7.46|12.0|||Mixed Models Analysis|Confidence intervals and p-values derived from a mixed model for repeated measures (MMRM)||Week 24: VAY736 5 mg vs. Placebo||12.00|-7.46|0.6457
72446127|NCT02962895|144408052|SUPERIORITY||Least Squares Mean Difference|3.26||||0.5132|TWO_SIDED|95.0|-6.55|13.06|||Mixed Models Analysis|Confidence intervals and p-values derived from a mixed model for repeated measures (MMRM)||Week 24: VAY736 50 mg vs. Placebo||13.06|-6.55|0.5132
72619336|NCT03142451|144769288|SUPERIORITY||Risk Ratio (RR)|1.191||||0.1278|TWO_SIDED|95.0|0.951|1.492||P-value is for the null hypothesis that the risk ratio equals 1.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by analysis center.||Statistical analysis for Week 8||1.492|0.951|0.1278
72619337|NCT03636269|144769347|SUPERIORITY||Odds Ratio (OR)|1.61||||0.02|TWO_SIDED|95.0|1.08|2.41|||Cui, Hung, Wang|||||2.41|1.08|0.020
72619338|NCT03636269|144769348|SUPERIORITY||Odds Ratio (OR)|1.77||||0.01|TWO_SIDED|95.0|1.14|2.74|||Cui, Hung, Wang|||||2.74|1.14|0.010
72619339|NCT03636269|144769349|SUPERIORITY||Mean Difference (Final Values)|-1.8|STANDARD_ERROR_OF_MEAN|1.29||0.171|TWO_SIDED|95.0|-4.3|0.8|||ANCOVA|||||0.8|-4.3|0.171
72446128|NCT02962895|144408052|SUPERIORITY||Least Squares Mean Difference|-4.77||||95|TWO_SIDED|95.0|-14.21|4.68|||Mixed Models Analysis|Confidence intervals and p-values derived from a mixed model for repeated measures (MMRM)||Week 24: VAY736 300 mg vs. Placebo||4.68|-14.21|95
72446129|NCT02962895|144408053|SUPERIORITY||Least Squares Mean Difference|0.11||||0.271|TWO_SIDED|95.0|-0.08|0.3|||Mixed Models Analysis|Confidence intervals and p-values derived from a mixed model for repeated measures (MMRM)||Week 24: VAY736 5 mg vs. Placebo (Stimulated salivary flow rate)||0.30|-0.08|0.2710
72446130|NCT02962895|144408053|SUPERIORITY||Least Squares Mean Difference|0.13||||0.1618|TWO_SIDED|95.0|-0.05|0.32|||Mixed Models Analysis|Confidence intervals and p-values derived from a mixed model for repeated measures (MMRM)||Week 24: VAY736 50 mg vs. Placebo (Stimulated salivary flow rate)||0.32|-0.05|0.1618
72446131|NCT02962895|144408053|SUPERIORITY||Least Squares Mean Difference|0.2||||0.0374|TWO_SIDED|95.0|0.01|0.38|||Mixed Models Analysis|Confidence intervals and p-values derived from a mixed model for repeated measures (MMRM)||Week 24: VAY736 300 mg vs. Placebo (Stimulated salivary flow rate)||0.38|0.01|0.0374
72446132|NCT02962895|144408053|SUPERIORITY||Least Squares Mean Difference|0.0||||0.9559|TWO_SIDED|95.0|-0.09|0.09|||Mixed Models Analysis|Confidence intervals and p-values derived from a mixed model for repeated measures (MMRM)||Week 24: VAY736 5 mg vs. Placebo (Unstimulated salivary flow rate)||0.09|-0.09|0.9559
72619340|NCT03636269|144769350|SUPERIORITY||Mean Difference (Final Values)|-1.1|STANDARD_ERROR_OF_MEAN|0.35||0.002|TWO_SIDED|95.0|-1.7|-0.4|||ANCOVA|||||-0.4|-1.7|0.002
72619341|NCT01368185|144769351|SUPERIORITY_OR_OTHER_LEGACY||% change SUA from baseline|4.6|STANDARD_DEVIATION|0.9|<|0.01||95.0|||||t-test, 2 sided||Percent change of month 3 SUA minus baseline SUA.|Comparison between Month 3 and Baseline||||<0.01
72619342|NCT01368185|144769352|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||McNemar|||||||<0.0001
72619343|NCT01368185|144769353|SUPERIORITY_OR_OTHER_LEGACY||% change DBP from Baseline|-7.1|STANDARD_DEVIATION|0.4|<|0.01||95.0|||||t-test, 2 sided||Percent change of month 3 DBP minus baseline DBP (n=1239).|Comparison between Month 3 and Baseline||||<0.01
72619344|NCT01368185|144769354|SUPERIORITY_OR_OTHER_LEGACY||% change SBP from Baseline|-9.1|STANDARD_DEVIATION|0.3|<|0.01||95.0|||||t-test, 2 sided||Percent change of month 3 SBP minus baseline SBP (n=1245).|Comparison between Month 3 and Baseline||||<0.01
72446133|NCT02962895|144408053|SUPERIORITY||Least Squares Mean Difference|0.0||||0.929|TWO_SIDED|95.0|-0.09|0.08|||Mixed Models Analysis|Confidence intervals and p-values derived from a mixed model for repeated measures (MMRM)||Week 24: VAY736 50 mg vs. Placebo (Unstimulated salivary flow rate)||0.08|-0.09|0.9290
72446134|NCT02962895|144408053|SUPERIORITY||Least Squares Mean Difference|-0.01||||0.7276|TWO_SIDED|95.0|-0.1|0.07|||Mixed Models Analysis|Confidence intervals and p-values derived from a mixed model for repeated measures (MMRM)||Week 24: VAY736 300 mg vs. Placebo (Unstimulated salivary flow rate)||0.07|-0.10|0.7276
72446135|NCT03476460|144408074|NON_INFERIORITY|"We considered a priori a difference of no more than 5% in the incidence of CA-AKI in the oral compared to the intravenous arm (non-inferiority margin) to be acceptable.~The non-inferiority of oral hydration would be shown if the upper limit of the 95% CI of the absolute risk difference between the groups was less than 5% (non-inferiority margin, indicated by the black dashed line)"|Risk Difference (RD)|1.0|||||TWO_SIDED|95.0|-4.8|7.0|||||The 95% confidence interval for the difference between the two independent proportions was calculated according to Wilson's method.|Sample size was calculated to assess the non-inferiority of oral compared to intravenous hydration. We expected a primary outcome rate of 7% in the intravenous arm. We considered a priori a difference of no more than 5% in the incidence of CA-AKI in the oral compared to the intravenous arm (non-inferiority margin) to be acceptable. Thus, 266 participants, 133 per arm, were required to ensure at least 80% power at a significance level of α = 2.5% (one-sided).||7.0|-4.8|
72619345|NCT03992482|144769355|OTHER|||||||1|||||||Kruskal-Wallis|||||||1.000
72619346|NCT03992482|144769356|OTHER|||||||0.0044|||||||Mixed Models Analysis|||||||0.0044
72619347|NCT03992482|144769357|OTHER|||||||0.0002|||||||Mixed Models Analysis|||||||0.0002
72619348|NCT01507103|144769358|SUPERIORITY_OR_OTHER||Effect estimate|-0.04||||0.794|TWO_SIDED|95.0|-0.72|0.65||Arm effect|type III SS F-test|||Category: CD8+ The difference between baseline and surgical tumor samples was analysed and compared across the 3 treatment arms (effect estimate for Arm A vs Arm C) based on an analysis of covariance (ANCOVA) model. Difference from baseline = Surgery value-Baseline value. Adjustment was based on ANCOVA model with treatment arm as factor and baseline value as covariate. No interaction included. Pairwise tests have been performed to compare Arm A with Arm C, Arm B with Arm C, and Arm A with Arm B||0.65|-0.72|0.794
72619349|NCT01507103|144769358|SUPERIORITY_OR_OTHER||Effect estimate|-0.2||||0.794|TWO_SIDED|95.0|-0.82|0.43||Arm effect|type III SS F-test|||Category: CD8+ The difference between baseline and surgical tumor samples was analysed and compared across the 3 treatment arms (effect estimate for Arm B vs Arm C) based on an ANCOVA model. Difference from baseline = Surgery value-Baseline value. Adjustment was based on ANCOVA model with treatment arm as factor and baseline value as covariate. No interaction included. Pairwise tests have been performed to compare Arm A with Arm C, Arm B with Arm C, and Arm A with Arm B||0.43|-0.82|0.794
72619350|NCT01507103|144769358|SUPERIORITY_OR_OTHER||Effect estimate|0.16||||0.794|TWO_SIDED|95.0|-0.49|0.82||Arm effect|type III SS F-test|||Category: CD8+ The difference between baseline and surgical tumor samples was analysed and compared across the 3 treatment arms (effect estimate for Arm A vs Arm B) based on an ANCOVA model. Difference from baseline = Surgery value-Baseline value. Adjustment was based on ANCOVA model with treatment arm as factor and baseline value as covariate. No interaction included. Pairwise tests have been performed to compare Arm A with Arm C, Arm B with Arm C, and Arm A with Arm B||0.82|-0.49|0.794
72619351|NCT01507103|144769358|SUPERIORITY_OR_OTHER||Effect estimate|0.02||||0.654|TWO_SIDED|95.0|-0.52|0.57||Arm effect|type III SS F-test|||Category: CD8+/GrB+ The difference between baseline and surgical tumor samples was analysed and compared across the 3 treatment arms (effect estimate for Arm A vs Arm C) based on an ANCOVA model. Difference from baseline = Surgery value-Baseline value. Adjustment was based on ANCOVA model with treatment arm as factor and baseline value as covariate. No interaction included. Pairwise tests have been performed to compare Arm A with Arm C, Arm B with Arm C, and Arm A with Arm B||0.57|-0.52|0.654
72446136|NCT03476460|144408075|SUPERIORITY|||||||0.299||||||A p-value \<0.05 (two-sided) was considered for statistical significance.|t-test, 2 sided|||Comparison between means of both arms at 24h from baseline||||0.299
72446137|NCT03476460|144408076|SUPERIORITY|||||||0.477||||||A p-value \<0.05 (two-sided) was considered for statistical significance.|t-test, 2 sided|||Comparison between means of both arms at 48h from baseline||||0.477
72446138|NCT03476460|144408077|SUPERIORITY|Comparison between means of both arms at 24h from baseline||||||0.042||||||A p-value \<0.05 (two-sided) was considered for statistical significance.|t-test, 2 sided|||||||0.042
72446139|NCT03476460|144408078|SUPERIORITY|Comparison between means of both arms at 48h from baseline||||||0.121||||||A p-value \<0.05 (two-sided) was considered for statistical significance|t-test, 2 sided|||||||0.121
72446140|NCT03476460|144408079|SUPERIORITY|Comparison between means of both arms at 24h from baseline||||||0.418||||||A p-value \<0.05 (two-sided) was considered for statistical significance.|t-test, 2 sided|||||||0.418
72446141|NCT03476460|144408080|SUPERIORITY|Comparison between means of both arms at 24h from baseline||||||0.901||||||A p-value \<0.05 (two-sided) was considered for statistical significance|t-test, 2 sided|||||||0.901
72446142|NCT03476460|144408081|SUPERIORITY|Comparison between means of both arms at 24h from baseline||||||0.72||||||A p-value \<0.05 (two-sided) was considered for statistical significance|Wilcoxon (Mann-Whitney)|||||||0.720
72446143|NCT03476460|144408082|SUPERIORITY|Comparison between means of both arms at 48h from baseline||||||0.688||||||A p-value \<0.05 (two-sided) was considered for statistical significance|Wilcoxon (Mann-Whitney)|||||||0.688
72446144|NCT03476460|144408083|SUPERIORITY|Comparison between means of both arms at 24h from baseline||||||0.535||||||A p-value \<0.05 (two-sided) was considered for statistical significance|t-test, 2 sided|||||||0.535
72446145|NCT03476460|144408084|SUPERIORITY|Comparison between means of both arms at 48h from baseline||||||0.338||||||A p-value \<0.05 (two-sided) was considered for statistical significance|t-test, 2 sided|||||||0.338
72446146|NCT03476460|144408085|SUPERIORITY|Comparison between means of both arms at 24h from baseline||||||0.764||||||A p-value \<0.05 (two-sided) was considered for statistical significance|t-test, 2 sided|||||||0.764
72446147|NCT03476460|144408086|SUPERIORITY|Comparison between means of both arms at 48h from baseline||||||0.458||||||A p-value \<0.05 (two-sided) was considered for statistical significance.|t-test, 2 sided|||||||0.458
72446148|NCT03476460|144408087|SUPERIORITY|Comparison between means of both arms at 24h from baseline||||||0.893||||||A p-value \<0.05 (two-sided) was considered for statistical significance.|t-test, 2 sided|||||||0.893
72446149|NCT03476460|144408088|SUPERIORITY|Comparison between means of both arms at 48h from baseline||||||0.645||||||A p-value \<0.05 (two-sided) was considered for statistical significance.|t-test, 2 sided|||||||0.645
72446150|NCT01606215|144408103|OTHER|||||||0.84|||||||t-test, 2 sided|||Week 4 data||||0.84
72446151|NCT01606215|144408103|OTHER|||||||0.62|||||||t-test, 2 sided|||Week 12 data||||0.62
72446152|NCT01606215|144408103|OTHER|||||||0.61|||||||t-test, 2 sided|||Week 24 data||||0.61
72446153|NCT01606215|144408106|OTHER|||||||0.77|||||||t-test, 2 sided|||Week 4||||0.77
72446154|NCT01606215|144408106|OTHER|||||||0.68|||||||t-test, 2 sided|||Week 12||||0.68
72446155|NCT01606215|144408106|OTHER|Week 24||||||0.48|||||||t-test, 2 sided|||Week 24||||0.48
72446156|NCT06132867|144408144|OTHER|A linear mixed-effects analysis of variance model was used for the analysis. The model included sequence, treatment, and period as fixed effects and participants nested within sequence as a random effect. Geometric mean ratios and 90 percent (%) confidence intervals (CIs) were calculated using the exponentiation of the difference between treatment least square means (LSM) from the analyses on the natural log-transformed of Cmax.|Geometric Mean Ratio (GMR) (%)|92.2|||||TWO_SIDED|90.0|86.98|97.74|||||GMR (%) was calculated as 100\*(Treatment A/Treatment B).|||97.74|86.98|
72446157|NCT06132867|144408145|OTHER|A linear mixed-effects analysis of variance model was used for the analysis. The model included sequence, treatment, and period as fixed effects and participants nested within sequence as a random effect. Geometric mean ratios and 90% CIs were calculated using the exponentiation of the difference between treatment LSM from the analyses on the natural log-transformed of AUClast.|GMR (%)|96.0|||||TWO_SIDED|90.0|88.48|104.16|||||GMR (%) was calculated as 100\*(Treatment A/Treatment B).|||104.16|88.48|
72446158|NCT06132867|144408146|OTHER|A linear mixed-effects analysis of variance model was used for the analysis. The model included sequence, treatment, and period as fixed effects and participants nested within sequence as a random effect. Geometric mean ratios and 90% CIs were calculated using the exponentiation of the difference between treatment LSM from the analyses on the natural log-transformed of AUCinf.|GMR (%)|95.84|||||TWO_SIDED|90.0|88.81|103.42|||||GMR (%) was calculated as 100\*(Treatment A/Treatment B).|||103.42|88.81|
72446159|NCT02995434|144408163|EQUIVALENCE|As reliable estimates of expected effect size were unknown, the study was powered to detect a medium effect (0.5 SD change), considered a reasonable clinically meaningful impact to obtain 80% power based on a repeated measures analysis of variance (RM ANOVA) with 2-tailed alpha of .05 model.|Mean Difference (Net)|-2.08|||||TWO_SIDED|95.0|-3.86|-0.3|||||Treatment effect = VR group - Control group; 95% confidence intervals estimated using the bootstrapping method|Null hypothesis: There is no difference between the reported daily pain experiences of participants during, or after exposure to VR immersive environments, overall and within four different VR immersive environments, compared to the equivalent applications experienced on a 2D computer screen.||-0.30|-3.86|
72446160|NCT02995434|144408163|EQUIVALENCE|As reliable estimates of expected effect size were unknown, the study was powered to detect a medium effect (0.5 SD change), considered a reasonable clinically meaningful impact to obtain 80% power based on a repeated measures analysis of variance (RM ANOVA) with 2-tailed alpha of .05 model|Mean Difference (Net)|0.53|||||TWO_SIDED|95.0|-1.24|2.37|||||Treatment effect = VR group - Control group; 95% confidence intervals estimated using the bootstrapping method|||2.37|-1.24|
72446161|NCT02995434|144408164|EQUIVALENCE|See section for primary outcome.|Mean Difference (Net)|1.08|||||TWO_SIDED|95.0|-1.59|3.95|||||Treatment effect = VR group - Control group; 95% confidence intervals estimated using the bootstrapping method|||3.95|-1.59|
72497800|NCT00792298|144525822|SUPERIORITY_OR_OTHER||LS Mean Difference: Week 4|-28.9|||<|0.001|TWO_SIDED|95.0|-42.1|-15.7|||Mixed Models Analysis|||A fixed sequential testing procedure assessed statistical significance, beginning with the highest dose. The comparison of suvorexant vs placebo had to be significant at α=0.05 at both Night 1 and Week 4 in order to assess statistical significance of the comparison of suvorexant vs placebo for the next highest dose. If a non-significant result was observed at either time point, the differences between suvorexant and placebo for SE was considered nonsignificant for this and all lower doses.||-15.7|-42.1|<0.001
72497801|NCT00792298|144525822|SUPERIORITY_OR_OTHER||LS Mean Difference: Night 1|-33.9|||<|0.001|TWO_SIDED|95.0|-46.4|-21.5|||Mixed Models Analysis|||A fixed sequential testing procedure assessed statistical significance, beginning with the highest dose. The comparison of suvorexant vs placebo had to be significant at α=0.05 at both Night 1 and Week 4 in order to assess statistical significance of the comparison of suvorexant vs placebo for the next highest dose. If a non-significant result was observed at either time point, the differences between suvorexant and placebo for SE was considered nonsignificant for this and all lower doses.||-21.5|-46.4|<0.001
72497802|NCT00792298|144525822|SUPERIORITY_OR_OTHER||LS Mean Difference: Week 4|-33.2|||<|0.001|TWO_SIDED|95.0|-46.3|-20.2|||Mixed Models Analysis|||A fixed sequential testing procedure assessed statistical significance, beginning with the highest dose. The comparison of suvorexant vs placebo had to be significant at α=0.05 at both Night 1 and Week 4 in order to assess statistical significance of the comparison of suvorexant vs placebo for the next highest dose. If a non-significant result was observed at either time point, the differences between suvorexant and placebo for SE was considered nonsignificant for this and all lower doses.||-20.2|-46.3|<0.001
72497803|NCT00792298|144525822|SUPERIORITY_OR_OTHER||LS Mean Difference: Night 1|-24.7|||<|0.001|TWO_SIDED|95.0|-37.1|-12.3|||Mixed Models Analysis|||A fixed sequential testing procedure assessed statistical significance, beginning with the highest dose. The comparison of suvorexant vs placebo had to be significant at α=0.05 at both Night 1 and Week 4 in order to assess statistical significance of the comparison of suvorexant vs placebo for the next highest dose. If a non-significant result was observed at either time point, the differences between suvorexant and placebo for SE was considered nonsignificant for this and all lower doses.||-12.3|-37.1|<0.001
72560890|NCT02274558|144652365|OTHER||Mean Difference (Final Values)|-3.1|STANDARD_ERROR_OF_MEAN|0.6|<|0.0001|TWO_SIDED|95.0|-4.2|-2.0|||Mixed-effect Model Repeated Measures|||"Control for multiplicity was accomplished through the a fixed-sequence testing procedure for Week 6 outcomes:~* AIMS dyskinesia total score mean change from baseline (CFB): valbenazine 80 mg vs. placebo.~* CGI-TD mean score: VBZ 80 mg vs. PBO.~* AIMS: VBZ 40 mg vs. PBO.~* CGI-TD: VBZ 40 mg vs. PBO.~For a test result in the above list to be considered statistically significant, all of the test results higher in the list must have been significant at the 0.05 level of significance."||-2.0|-4.2|<0.0001
72446162|NCT02995434|144408164|EQUIVALENCE|See section on primary outcome|Mean Difference (Net)|2.16|||||TWO_SIDED|95.0|-0.55|5.08|||||Treatment effect = VR group - Control group; 95% confidence intervals estimated using the bootstrapping method|||5.08|-0.55|
72560891|NCT02274558|144652365|OTHER||Mean Difference (Final Values)|-1.8|STANDARD_ERROR_OF_MEAN|0.6||0.0021|TWO_SIDED|95.0|-3.0|-0.7||Nominal P-value, not adjusted for multiplicity. See comments in above statistical analysis overview regarding the fixed-sequence testing procedure to control for multiplicity.|Mixed-effect Model Repeated Measures|||||-0.7|-3.0|0.0021
72446163|NCT02995434|144408164|EQUIVALENCE|See section on primary outcome|Mean Difference (Net)|0.39|||||TWO_SIDED|95.0|-2.64|3.42|||||Treatment effect = VR group - Control group; 95% confidence intervals estimated using the bootstrapping method|||3.42|-2.64|
72446164|NCT02995434|144408164|EQUIVALENCE|See section on primary outcome|Mean Difference (Net)|2.56|||||TWO_SIDED|95.0|-0.08|5.48|||||Treatment effect = VR group - Control group; 95% confidence intervals estimated using the bootstrapping method|||5.48|-0.08|
72560892|NCT02274558|144652366|OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.1||0.0742|TWO_SIDED|95.0|-0.5|0.0|||Mixed-effect Model Repeated Measures|||||0.0|-0.5|0.0742
72446165|NCT02995434|144408165|EQUIVALENCE|See comment in primary outcome|Mean Difference (Net)|0.37|||||TWO_SIDED|95.0|-0.71|1.5|||||Treatment effect = VR group - Control group; 95% confidence intervals estimated using the bootstrapping method|||1.5|-0.71|
72560893|NCT02274558|144652366|OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.1||0.056|TWO_SIDED|95.0|-0.5|0.0|||Mixed-effect Model Repeated Measures|||||0.0|-0.5|0.0560
72560894|NCT02274558|144652367|OTHER|||||||0.02|||||||Cochran-Mantel-Haenszel|||||||0.0200
72560895|NCT02274558|144652367|OTHER||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
72560896|NCT02655224|144652368|SUPERIORITY|The point estimate and 2-sided 95% confidence interval of odds ratio were calculated between relugolix 40 mg group and placebo group.|Odds Ratio (OR)|42.071|||<|0.0001|TWO_SIDED|95.0|5.113|346.181|||Fisher's Exact Test||Relugolix 40 mg/Placebo|||346.181|5.113|<0.0001
72560897|NCT02655224|144652369|OTHER|The point estimate and 2-sided 95% confidence interval of odds ratio were calculated between relugolix 40 mg group and placebo group.|Odds Ratio (OR)|29.176|||||TWO_SIDED|95.0|3.555|239.478|||||Relugolix 40 mg/Placebo|||239.478|3.555|
72446166|NCT02995434|144408165|EQUIVALENCE|See comment in primary outcome|Mean Difference (Net)|0.62|||||TWO_SIDED|95.0|-0.49|1.89|||||Treatment effect = VR group - Control group; 95% confidence intervals estimated using the bootstrapping method|||1.89|-0.49|
72446167|NCT02995434|144408165|EQUIVALENCE|See comments in primary outcome|Mean Difference (Net)|-0.13|||||TWO_SIDED|95.0|-1.19|1.09|||||Treatment effect = VR group - Control group; 95% confidence intervals estimated using the bootstrapping method|||1.09|-1.19|
72446168|NCT02995434|144408165|EQUIVALENCE|See comment in primary outcome|Mean Difference (Net)|0.33|||||TWO_SIDED|95.0|-0.88|1.57|||||Treatment effect = VR group - Control group; 95% confidence intervals estimated using the bootstrapping method|||1.57|-0.88|
72446169|NCT02995434|144408166|EQUIVALENCE|See comment in primary outcome|Mean Difference (Net)|2.48|||||TWO_SIDED|95.0|0.02|4.7|||||Treatment effect = VR group - Control group; 95% confidence intervals estimated using the bootstrapping method|||4.70|0.02|
72446170|NCT02995434|144408166|EQUIVALENCE|See comment in primary outcome|Mean Difference (Net)|2.04|||||TWO_SIDED|95.0|-0.42|4.39|||||Treatment effect = VR group - Control group; 95% confidence intervals estimated using the bootstrapping method|||4.39|-0.42|
72446171|NCT02995434|144408166|EQUIVALENCE|See comment in primary outcome|Mean Difference (Net)|3.79|||||TWO_SIDED|95.0|1.02|6.08|||||Treatment effect = VR group - Control group; 95% confidence intervals estimated using the bootstrapping method|||6.08|1.02|
72389872|NCT00282984|144287683|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.19|||<|0.0001||95.0|1.97|5.18||To preserve type I family-wise error rate of 0.05, a step-down procedure was used for the analysis of primary \& 2 key secondary endpts. Hierarchy of comparisons: 1) 4-week CQR for Weeks 9 through 12, 2) CA at Week 52, 3) LTQR through Week 52.|Regression, Logistic|Logistic regression model fitted to primary endpoint \& key secondary endpoints; included main effects of treatment group \& center as independent var.||Estimates for expected and clinically meaningful var \& pbo 4-week CQR for Weeks 9 - 12 of trtmt were based on response rates \& corresponding 95% odds ratio CI from A30510285 and A30510366 study results. Total n=700 randomized var or pbo 1:1 should have provided at least 99% power to detect difference in primary endpt b/w var \& pbo, assuming true 4-week CQR of 0.18 for pbo \& 0.40 for var (odds ratio of at least 3.04) \& a power of 84% for the 2 key secondary endpts.||5.18|1.97|<0.0001
72389873|NCT00282984|144287684|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.82|||<|0.0001||95.0|1.82|4.38||To preserve type I family-wise error rate of 0.05, a step-down procedure was used for the analysis of primary \& 2 key secondary endpoints. Hierarchy of comparisons: 1) 4-week CQR for Weeks 9 through 12, 2) CA at Week 52, 3) the LTQR through Week 52.|Regression, Logistic|Logistic regression model fitted to primary endpoint \& key secondary endpoints; included main effects of trtmt group and center as independent var.||Estimates for expected and clinically meaningful varenicline (var) \& pbo 4-week CQR for Weeks 9 - 12 of treatment were based on response rates \& corresponding 95% odds ratio CI from A30510285 and A30510366 study results. Total n=700 randomized var or pbo 1:1 should have provided at least 99% power to detect difference in primary endpt b/w varenicline \& pbo, assuming true 4-week CQR of 0.18 for pbo \& 0.40 for var (odds ratio of at least 3.04), and a power of 84% for the 2 key secondary endpts.||4.38|1.82|<0.0001
72497804|NCT00792298|144525822|SUPERIORITY_OR_OTHER||LS Mean Difference: Week 4|-28.1|||<|0.001|TWO_SIDED|95.0|-41.0|-15.1|||Mixed Models Analysis|||A fixed sequential testing procedure assessed statistical significance, beginning with the highest dose. The comparison of suvorexant vs placebo had to be significant at α=0.05 at both Night 1 and Week 4 in order to assess statistical significance of the comparison of suvorexant vs placebo for the next highest dose. If a non-significant result was observed at either time point, the differences between suvorexant and placebo for SE was considered nonsignificant for this and all lower doses.||-15.1|-41.0|<0.001
72497805|NCT00792298|144525822|SUPERIORITY_OR_OTHER||LS Mean Difference: Night 1|-21.2|||<|0.001|TWO_SIDED|95.0|-33.5|-8.8|||Mixed Models Analysis|||A fixed sequential testing procedure assessed statistical significance, beginning with the highest dose. The comparison of suvorexant vs placebo had to be significant at α=0.05 at both Night 1 and Week 4 in order to assess statistical significance of the comparison of suvorexant vs placebo for the next highest dose. If a non-significant result was observed at either time point, the differences between suvorexant and placebo for SE was considered nonsignificant for this and all lower doses.||-8.8|-33.5|<0.001
72497806|NCT00792298|144525822|SUPERIORITY_OR_OTHER||LS Mean Difference: Week 4|-21.4||||0.001|TWO_SIDED|95.0|-34.2|-8.7|||Mixed Models Analysis|||A fixed sequential testing procedure assessed statistical significance, beginning with the highest dose. The comparison of suvorexant vs placebo had to be significant at α=0.05 at both Night 1 and Week 4 in order to assess statistical significance of the comparison of suvorexant vs placebo for the next highest dose. If a non-significant result was observed at either time point, the differences between suvorexant and placebo for SE was considered nonsignificant for this and all lower doses.||-8.7|-34.2|0.001
72497807|NCT00792298|144525823|SUPERIORITY_OR_OTHER||LS Mean Difference: Night 1|-25.4|||<|0.001|TWO_SIDED|95.0|-37.7|-13.1|||Mixed Models Analysis|||A fixed sequential testing procedure assessed statistical significance, beginning with the highest dose. The comparison of suvorexant vs placebo had to be significant at α=0.05 at both Night 1 and Week 4 in order to assess statistical significance of the comparison of suvorexant vs placebo for the next highest dose. If a non-significant result was observed at either time point, the differences between suvorexant and placebo for SE was considered nonsignificant for this and all lower doses.||-13.1|-37.7|<0.001
72497808|NCT00792298|144525823|SUPERIORITY_OR_OTHER||LS Mean Difference: Week 4|-9.5||||0.068|TWO_SIDED|95.0|-19.7|0.7|||Mixed Models Analysis|||A fixed sequential testing procedure assessed statistical significance, beginning with the highest dose. The comparison of suvorexant vs placebo had to be significant at α=0.05 at both Night 1 and Week 4 in order to assess statistical significance of the comparison of suvorexant vs placebo for the next highest dose. If a non-significant result was observed at either time point, the differences between suvorexant and placebo for SE was considered nonsignificant for this and all lower doses.||0.7|-19.7|0.068
72560898|NCT02655224|144652370|OTHER|The mean differences between relugolix 40 mg group and placebo group and the two-sided 95% confidence intervals were calculated.|Mean Difference (Final Values)|-0.49|||||TWO_SIDED|95.0|-1.05|0.069|||||Relugolix 40 mg-Placebo|||0.069|-1.050|
72389874|NCT00282984|144287685|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.97|||<|0.0001||95.0|4.17|8.56|||Regression, Logistic|||Week 12 analysis||8.56|4.17|<0.0001
72389875|NCT00282984|144287686|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.93|||<|0.0001||95.0|2.03|4.23|||Regression, Logistic|||24 Week analysis||4.23|2.03|<0.0001
72389876|NCT00282984|144287687|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.93||||0.0003||95.0|1.34|2.77|||Regression, Logistic|||52 Week analysis||2.77|1.34|0.0003
72389877|NCT00282984|144287688|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.05||||0.0001||95.0|1.41|2.97|||Regression, Logistic|||||2.97|1.41|0.0001
72389878|NCT00282984|144287689|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.86|||<|0.0001||95.0|2.51|5.93|||Regression, Logistic|||||5.93|2.51|<0.0001
72389879|NCT00282984|144287691|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.85|||<|0.0001||95.0|2.58|5.75|||Regression, Logistic|||||5.75|2.58|<0.0001
72389880|NCT02516046|144287723|OTHER||Fleiss' kappa|0.8|||||TWO_SIDED|95.0|0.74|0.86||||||Inter-reader agreement analysis using Fleiss' kappa. The hypothesis tested was that the observed kappa values were ≥0.64 and the lower bound of the 2-sided 95% CIs were ≥0.55 for the inter-reader agreement among readers.||0.86|0.74|
72395184|NCT01405456|144297037|SUPERIORITY|||||||0.42|||||||Wilcoxon (Mann-Whitney)|||Change in Visceral Adipose Tissue area as measured by magnetic resonance imaging of the abdomen from baseline to 6 months||||0.42
72497809|NCT00792298|144525823|SUPERIORITY_OR_OTHER||LS Mean Difference: Night 1|-23.1|||<|0.001|TWO_SIDED|95.0|-35.3|-10.9|||Mixed Models Analysis|||A fixed sequential testing procedure assessed statistical significance, beginning with the highest dose. The comparison of suvorexant vs placebo had to be significant at α=0.05 at both Night 1 and Week 4 in order to assess statistical significance of the comparison of suvorexant vs placebo for the next highest dose. If a non-significant result was observed at either time point, the differences between suvorexant and placebo for SE was considered nonsignificant for this and all lower doses.||-10.9|-35.3|<0.001
72497810|NCT00792298|144525823|SUPERIORITY_OR_OTHER||LS Mean Difference: Week 4|-3.8||||0.459|TWO_SIDED|95.0|-13.8|6.3|||Mixed Models Analysis|||A fixed sequential testing procedure assessed statistical significance, beginning with the highest dose. The comparison of suvorexant vs placebo had to be significant at α=0.05 at both Night 1 and Week 4 in order to assess statistical significance of the comparison of suvorexant vs placebo for the next highest dose. If a non-significant result was observed at either time point, the differences between suvorexant and placebo for SE was considered nonsignificant for this and all lower doses.||6.3|-13.8|0.459
72497811|NCT00792298|144525823|SUPERIORITY_OR_OTHER||LS Mean Difference: Night 1|-9.4||||0.13|TWO_SIDED|95.0|-21.5|2.8|||Mixed Models Analysis|||A fixed sequential testing procedure assessed statistical significance, beginning with the highest dose. The comparison of suvorexant vs placebo had to be significant at α=0.05 at both Night 1 and Week 4 in order to assess statistical significance of the comparison of suvorexant vs placebo for the next highest dose. If a non-significant result was observed at either time point, the differences between suvorexant and placebo for SE was considered nonsignificant for this and all lower doses.||2.8|-21.5|0.130
72497812|NCT00792298|144525823|SUPERIORITY_OR_OTHER||LS Mean Difference: Week 4|-22.3|||<|0.001|TWO_SIDED|95.0|-32.3|-12.3|||Mixed Models Analysis|||A fixed sequential testing procedure assessed statistical significance, beginning with the highest dose. The comparison of suvorexant vs placebo had to be significant at α=0.05 at both Night 1 and Week 4 in order to assess statistical significance of the comparison of suvorexant vs placebo for the next highest dose. If a non-significant result was observed at either time point, the differences between suvorexant and placebo for SE was considered nonsignificant for this and all lower doses.||-12.3|-32.3|<0.001
72560899|NCT02655224|144652371|OTHER|The mean differences between relugolix 40 mg group and placebo group and the two-sided 95% confidence intervals were calculated.|Mean Difference (Final Values)|11.96|||||TWO_SIDED|95.0|-3.201|27.112|||||Relugolix 40 mg-Placebo|||27.112|-3.201|
72560900|NCT02655224|144652372|OTHER|The point estimate and 2-sided 95% confidence interval of odds ratio were calculated between relugolix 40 mg group and placebo group.|Odds Ratio (OR)|5.625|||||TWO_SIDED|95.0|1.605|19.709|||||Relugolix 40 mg/Placebo. Statistical analysis for Day 29 to 56 and Day 57 to 84, the odds ratio was calculated. For Day 1 to 28, its ratio was not calculated due to zero cell.|Day 29 to 56||19.709|1.605|
72389881|NCT00114530|144287725|SUPERIORITY|||||||0.013||||||A Data and Safety Monitoring Board reviewed 4 pre-specified futility analyses that included an ability to stop for efficacy with p\<0.0001, leaving alpha equal to 0.0496 for the primary ITT analysis of the GRCS at 54 months post-randomization.|Wilcoxon (Mann-Whitney)|||||||0.013
72389882|NCT00114530|144287726|SUPERIORITY|||||||0.004|||||||Wilcoxon (Mann-Whitney)|||||||0.004
72389883|NCT00114530|144287727|SUPERIORITY|||||||0.008|||||||Wilcoxon (Mann-Whitney)|||||||0.008
72389884|NCT00114530|144287728|SUPERIORITY|||||||0.003|||||||Wilcoxon (Mann-Whitney)|||||||0.003
72389885|NCT00114530|144287729|SUPERIORITY|||||||0.059|||||||Fisher Exact|||Treatment arm comparisons of EFS at Month 54.||||0.059
72389886|NCT00114530|144287729|SUPERIORITY|||||||0.06|||||||Log Rank|||Treatment arm comparisons of Kaplan-Meier curves for EFS through Month 72||||0.06
72389887|NCT00114530|144287730|SUPERIORITY|||||||0.021|||||||Fisher Exact|||Treatment arm comparisons of EFS at Month 54.||||0.021
72389888|NCT00114530|144287730|SUPERIORITY|||||||0.03|||||||Log Rank|||Treatment arm comparisons of Kaplan-Meier curves for EFS through Month 72||||0.03
72389889|NCT00114530|144287731|SUPERIORITY|||||||0.059|||||||Fisher Exact|||||||0.059
72389890|NCT00114530|144287732|SUPERIORITY|||||||0.021|||||||Fisher Exact|||||||0.021
72389891|NCT00114530|144287733|SUPERIORITY|||||||0.48|||||||Fisher Exact|||||||0.48
72389892|NCT00114530|144287734|SUPERIORITY|||||||0.49|||||||Fisher Exact|||||||0.49
72389893|NCT00114530|144287735|SUPERIORITY|||||||0.48|||||||Fisher Exact|||||||0.48
72389894|NCT00114530|144287736|SUPERIORITY|||||||0.49|||||||Fisher Exact|||||||0.49
72389895|NCT00114530|144287737|SUPERIORITY|||||||0.28|||||||Fisher Exact|||Treatment arm comparisons of overall survival at Month 54.||||0.28
72389896|NCT00114530|144287737|SUPERIORITY|||||||0.05|||||||Log Rank|||Treatment arm comparisons of Kaplan-Meier curves for overall survival through Month 72.||||0.05
72389897|NCT00114530|144287738|SUPERIORITY|||||||0.19|||||||Fisher Exact|||Treatment arm comparisons of overall survival at Month 54.||||0.19
72389898|NCT00114530|144287738|SUPERIORITY|||||||0.02|||||||Log Rank|||Treatment arm comparisons of Kaplan-Meier curves for overall survival through Month 72.||||0.02
72389899|NCT00114530|144287739|SUPERIORITY|||||||0.28|||||||Fisher Exact|||||||0.28
72389900|NCT00114530|144287740|SUPERIORITY|||||||0.19|||||||Fisher Exact|||||||0.19
72389901|NCT00114530|144287741|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|Computed as Mantel Haenszel Chi Square using modified ridit scores.||This analysis is not stratified. EFS survivors and failures are pooled within each treatment arm.||||<0.001
72389902|NCT00114530|144287741|SUPERIORITY|||||||0.01|||||||Wilcoxon (Mann-Whitney)|Van Elteren extension of the Wilcoxon Rank Sum||This analysis is stratified by EFS status.||||0.01
72389903|NCT00114530|144287742|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|Computed as Mantel Haenszel Chi Square using modified ridit scores.||This analysis is not stratified. EFS survivors and failures are pooled within each treatment arm.||||<0.001
72389904|NCT00114530|144287742|SUPERIORITY|||||||0.002|||||||Wilcoxon (Mann-Whitney)|Van Elteren extension of the Wilcoxon Rank Sum||This analysis is stratified by EFS status.||||0.002
72395185|NCT01405456|144297038|SUPERIORITY|||||||0.51|||||||Wilcoxon (Mann-Whitney)|||Change in Liver Fat (Intrahepatic Lipid) as measured by magnetic resonance spectroscopy from baseline to 6 months||||0.51
72560901|NCT02655224|144652372|OTHER|The point estimate and 2-sided 95% confidence interval of odds ratio were calculated between relugolix 40 mg group and placebo group.|Odds Ratio (OR)|9.865|||||TWO_SIDED|95.0|2.784|34.955|||||Relugolix 40 mg/Placebo. Statistical analysis for Day 29 to 56 and Day 57 to 84, the odds ratio was calculated. For Day 1 to 28, its ratio was not calculated due to zero cell.|Day 57 to 84||34.955|2.784|
72560902|NCT02655224|144652373|OTHER|The point estimate and 2-sided 95% confidence interval of odds ratio were calculated between relugolix 40 mg group and placebo group.|Odds Ratio (OR)|5.438|||||TWO_SIDED|95.0|1.071|27.609|||||Relugolix 40 mg/Placebo. Statistical analysis for Day 29 to 56 and Day 57 to 84, the odds ratio was calculated. For Day 1 to 28, its ratio was not calculated due to zero cell.|Day 29 to 56||27.609|1.071|
72560903|NCT02655224|144652373|OTHER|The point estimate and 2-sided 95% confidence interval of odds ratio were calculated between relugolix 40 mg group and placebo group.|Odds Ratio (OR)|12.794|||||TWO_SIDED|95.0|2.603|62.88|||||Relugolix 40 mg/Placebo. Statistical analysis for Day 29 to 56 and Day 57 to 84, the odds ratio was calculated. For Day 1 to 28, its ratio was not calculated due to zero cell.|Day 57 to 84||62.880|2.603|
72560904|NCT02655224|144652374|OTHER|The mean differences between relugolix 40 mg group and placebo group and the two-sided 95% confidence intervals were calculated.|Mean Difference (Each Period)|0.09|||||TWO_SIDED|95.0|-0.574|0.745|||||Relugolix 40 mg-Placebo|Day 1 to 28||0.745|-0.574|
72560905|NCT02655224|144652374|OTHER|The mean differences between relugolix 40 mg group and placebo group and the two-sided 95% confidence intervals were calculated.|Mean Difference (Each Period)|-0.57|||||TWO_SIDED|95.0|-1.19|0.049|||||Relugolix 40 mg-Placebo|Day 29 to 56||0.049|-1.190|
72560906|NCT02655224|144652374|OTHER|The mean differences between relugolix 40 mg group and placebo group and the two-sided 95% confidence intervals were calculated.|Mean Difference (Each Period)|-0.54|||||TWO_SIDED|95.0|-1.074|-0.012|||||Relugolix 40 mg-Placebo|Day 57 to 84||-0.012|-1.074|
72560907|NCT02655224|144652375|OTHER|The mean differences between relugolix 40 mg group and placebo group and the two-sided 95% confidence intervals were calculated.|Mean Difference (Each Period)|4.17|||||TWO_SIDED|95.0|-11.507|19.839|||||Relugolix 40 mg-Placebo|Day 1 to 28||19.839|-11.507|
72560908|NCT02655224|144652375|OTHER|The mean differences between relugolix 40 mg group and placebo group and the two-sided 95% confidence intervals were calculated.|Mean Difference (Each Period)|12.7|||||TWO_SIDED|95.0|-3.098|28.494|||||Relugolix 40 mg-Placebo|Day 29 to 56||28.494|-3.098|
72560909|NCT02655224|144652375|OTHER|The mean differences between relugolix 40 mg group and placebo group and the two-sided 95% confidence intervals were calculated.|Mean Difference (Each Period)|11.6|||||TWO_SIDED|95.0|-3.554|26.745|||||Relugolix 40 mg-Placebo|Day 57 to 84||26.745|-3.554|
72497813|NCT00792298|144525823|SUPERIORITY_OR_OTHER||LS Mean Difference: Night 1|-3.4||||0.577|TWO_SIDED|95.0|-15.6|8.7|||Mixed Models Analysis|||A fixed sequential testing procedure assessed statistical significance, beginning with the highest dose. The comparison of suvorexant vs placebo had to be significant at α=0.05 at both Night 1 and Week 4 in order to assess statistical significance of the comparison of suvorexant vs placebo for the next highest dose. If a non-significant result was observed at either time point, the differences between suvorexant and placebo for SE was considered nonsignificant for this and all lower doses.||8.7|-15.6|0.577
72560910|NCT04592419|144652381|NON_INFERIORITY|The maximum clinically acceptable true difference between KSI-301 and aflibercept among BRVO participants to be considered non-inferior is 4.5 ETDRS letters, i.e. the non-inferiority margin (NI) is 4.5 letters.|Adjusted mean difference|-1.4|STANDARD_ERROR_OF_MEAN|0.87||0.0004|TWO_SIDED|95.02|-3.11|0.3|||Mixed Models Analysis|MMRM model with treatment, visit, treatment × visit interaction, baseline BCVA, disease duration, and geographical location as covariates.||||0.30|-3.11|.0004
72560911|NCT04592419|144652382|NON_INFERIORITY|The maximum clinically acceptable true difference between KSI-301 and aflibercept among BRVO participants to be considered non-inferior is 4.5 ETDRS letters, i.e. the non-inferiority margin (NI) is 4.5 letters.|Adjusted mean difference|-2.5|STANDARD_ERROR_OF_MEAN|0.9||0.0243|TWO_SIDED|95.02|-4.24|-0.71|||Mixed Models Analysis|MMRM model treatment, visit, treatment × visit interaction, RVO subtype, baseline BCVA, disease duration, and geographical location as covariates.||||-0.71|-4.24|.0243
72560912|NCT02951195|144652418|SUPERIORITY||LS Mean Difference|6.4||||0.0207|TWO_SIDED|95.0|0.3|12.6|||Mixed-effects Model for Repeated Measure|||||12.6|0.3|0.0207
72560913|NCT02951195|144652418|SUPERIORITY||LS Mean Difference|10.5||||0.0002|TWO_SIDED|95.0|5.0|15.9|||Mixed-effects Model for Repeated Measure|||||15.9|5.0|0.0002
72560914|NCT02951195|144652418|SUPERIORITY||LS Mean Difference|8.8||||0.0019|TWO_SIDED|95.0|3.0|14.5|||Mixed-effects Model for Repeated Measure|||||14.5|3.0|0.0019
72560915|NCT02951195|144652418|SUPERIORITY||LS Mean Difference|8.3||||0.054|TWO_SIDED|95.0|-2.1|18.7|||Mixed-effects Model for Repeated Measure|||||18.7|-2.1|0.0540
72560916|NCT02951195|144652419|SUPERIORITY||LS Mean Difference|8.7||||0.0007|TWO_SIDED|95.0|3.7|13.8|||Mixed-effects Model for Repeated Measure|||||13.8|3.7|0.0007
72560917|NCT02951195|144652420|SUPERIORITY||Least Squares (LS) Mean Difference|-19.5||||0.0018|TWO_SIDED|95.0|-32.2|-6.8|||Mixed-effects Model for Repeated Measure|||||-6.8|-32.2|0.0018
72560918|NCT02951195|144652420|SUPERIORITY||LS Mean Difference|-13.6||||0.0106|TWO_SIDED|95.0|-25.0|-2.1|||Mixed-effects Model for Repeated Measure|||||-2.1|-25.0|0.0106
72560919|NCT02951195|144652420|SUPERIORITY||LS Mean Difference|-27.5|||<|0.0001|TWO_SIDED|95.0|-38.6|-16.3|||Mixed-effects Model for Repeated Measure|||||-16.3|-38.6|<0.0001
72560920|NCT02951195|144652420|SUPERIORITY||LS Mean Difference|-24.8||||0.0017|TWO_SIDED|95.0|-40.0|-9.7|||Mixed-effects Model for Repeated Measure|||||-9.7|-40.0|0.0017
72560921|NCT02951195|144652421|SUPERIORITY||LS Mean Difference|-23.9|||<|0.0001|TWO_SIDED|95.0|-33.7|-14.1|||Mixed-effects Model for Repeated Measure|||||-14.1|-33.7|<0.0001
72560922|NCT02951195|144652422|SUPERIORITY||LS Mean Difference|12.5||||0.0166|TWO_SIDED|95.0|1.1|24.0|||Mixed-effects Model for Repeated Measure|||||24.0|1.1|0.0166
72560923|NCT02951195|144652422|SUPERIORITY||LS Mean Difference|21.3|||<|0.0001|TWO_SIDED|95.0|11.2|31.4|||Mixed-effects Model for Repeated Measure|||||31.4|11.2|<0.0001
72560924|NCT02951195|144652422|SUPERIORITY||LS Mean Difference|17.1||||0.0013|TWO_SIDED|95.0|6.3|27.8|||Mixed-effects Model for Repeated Measure|||||27.8|6.3|0.0013
72446172|NCT02995434|144408166|EQUIVALENCE|See comment in primary outcome|Mean Difference (Net)|3.18|||||TWO_SIDED|95.0|0.68|5.69|||||Treatment effect = VR group - Control group; 95% confidence intervals estimated using the bootstrapping method|||5.69|0.68|
72446173|NCT02995434|144408167|EQUIVALENCE|See comment in primary outcome|Mean Difference (Net)|-2.31|||||TWO_SIDED|95.0|-5.63|0.98|||||Treatment effect = VR group - Control group; 95% confidence intervals estimated using the bootstrapping method|||0.98|-5.63|
72446174|NCT02995434|144408167|EQUIVALENCE|See comment in primary outcome|Mean Difference (Net)|-3.9|||||TWO_SIDED|95.0|-7.35|-0.48|||||Treatment effect = VR group - Control group; 95% confidence intervals estimated using the bootstrapping method|||-0.48|-7.35|
72446175|NCT02995434|144408167|EQUIVALENCE|See comment in primary outcome|Mean Difference (Net)|-0.87|||||TWO_SIDED|95.0|-4.11|2.62|||||Treatment effect = VR group - Control group; 95% confidence intervals estimated using the bootstrapping method|||2.62|-4.11|
72446176|NCT02995434|144408167|EQUIVALENCE|See comments in primary outcome|Median Difference (Net)|-2.95|||||TWO_SIDED|95.0|-6.1|0.41|||||Treatment effect = VR group - Control group; 95% confidence intervals estimated using the bootstrapping method.|||0.41|-6.10|
72446177|NCT04873401|144408168|SUPERIORITY||Odds Ratio (OR)|1.05|STANDARD_ERROR_OF_MEAN|0.49||0.928|TWO_SIDED|95.0|0.39|2.79|||Regression, Logistic|||||2.79|0.39|0.928
72446178|NCT04873401|144408169|SUPERIORITY||Median Difference (Final Values)|-0.173|STANDARD_ERROR_OF_MEAN|0.147||0.24|TWO_SIDED|95.0|-0.24|0.115|||Regression, Linear|||||0.115|-0.24|0.240
72446179|NCT04873401|144408170|SUPERIORITY||Slope|0.1171|STANDARD_ERROR_OF_MEAN|0.062||0.367|TWO_SIDED|95.0|0.05|0.29|||Regression, Linear|||||0.29|0.05|0.367
72446180|NCT04873401|144408171|SUPERIORITY||Slope|0.171|STANDARD_ERROR_OF_MEAN|0.062||0.005|TWO_SIDED|95.0|0.05|0.29|||Regression, Linear|||||0.29|0.05|0.005
72446181|NCT01333969|144408175|SUPERIORITY||Mean Difference (Final Values)|-0.71||||0.043|TWO_SIDED|95.0|-1.4|-0.02|||GEE|Regression analysis using the generalized estimating equations (GEE) method to compare the changes over time in VAS scores at rest and with exercise||||-0.02|-1.40|.043
72446182|NCT01333969|144408176|OTHER||Mean Difference (Final Values)|0.043||||0.043|TWO_SIDED||||||t-test, 2 sided|||||||.043
72446183|NCT01333969|144408177|SUPERIORITY||Mean Difference (Final Values)|0.584||||0.584|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.584
72446184|NCT01333969|144408178|SUPERIORITY||Mean Difference (Final Values)|0.763||||0.763|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.763
72446185|NCT01333969|144408179|SUPERIORITY||Mean Difference (Final Values)|0.602||||0.602|TWO_SIDED||||||GEE|Regression analyses based on the generalized estimating equations (GEE) method||||||.602
72446186|NCT01333969|144408180|SUPERIORITY||Mean Difference (Final Values)|0.8656||||0.8656|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.8656
72446187|NCT01333969|144408181|SUPERIORITY||Mean Difference (Final Values)|0.8422||||0.8422|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.8422
72446188|NCT01333969|144408182|SUPERIORITY||Mean Difference (Final Values)|0.526||||0.526|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.526
72446189|NCT01333969|144408183|SUPERIORITY||Mean Difference (Final Values)|0.526||||0.526|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.526
72446190|NCT04760678|144408219|OTHER|Fisher's exact test||||||0.107|||||||Fisher Exact|||||||0.107
72446191|NCT05516147|144408264|SUPERIORITY||||||<|0.01||||||A one-sample t-test was used to assess whether the mean was different from a known Constructive Engagement mean of 0.85 for standard programming.|t-test, 2 sided|||A one-sample t-test was used to assess whether the mean was different from a known Constructive Engagement mean of 0.85 for standard programming.||||<.01
72446192|NCT05516147|144408265|SUPERIORITY||||||<|0.01||||||A one-sample t-test was used to assess whether the mean was different from a known Passive Engagement mean of 1.06 for standard programming.|t-test, 2 sided|A one-sample t-test was used to assess whether the mean was different from a known Passive Engagement mean of 1.06 for standard programming.||A one-sample t-test was used to assess whether the mean was different from a known Passive Engagement mean of 1.06 for standard programming.||||<.01
72446193|NCT05516147|144408266|SUPERIORITY|||||||0.06||||||A one-sample t-test was used to assess whether the mean was different from a known Other Engagement mean of 0.42 for standard programming.|t-test, 2 sided|A one-sample t-test was used to assess whether the mean was different from a known Other Engagement mean of 0.42 for standard programming.||A one-sample t-test was used to assess whether the mean was different from a known Other Engagement mean of 0.42 for standard programming.||||0.06
72446194|NCT05516147|144408267|SUPERIORITY||||||<|0.01|||||||t-test, 2 sided|||A one-sample t-test was used to assess whether the mean was different from a known Non Engagement mean of 0.40 for standard programming.||||<.01
72446195|NCT05516147|144408269|SUPERIORITY|||||||0.81|||||||t-test, 2 sided|||baseline score vs. post-treatment, paired sample t-test||||0.81
72446196|NCT05516147|144408270|SUPERIORITY|||||||0.2|||||||t-test, 2 sided|||baseline vs. post-treatment, paired sample t-test||||0.20
72446197|NCT05516147|144408271|SUPERIORITY|||||||0.83|||||||t-test, 2 sided|||baseline vs. post-treatment, paired sample t-test||||0.83
72446198|NCT05516147|144408272|SUPERIORITY|||||||0.32|||||||t-test, 2 sided|||baseline vs. post-treatment, paired sample t-test||||0.320
72446199|NCT05386758|144408275|OTHER||Gemetric Mean Ratio (GMR)|1.24|||||TWO_SIDED|90.0|0.94|1.64||||||||1.64|0.94|
72446200|NCT05386758|144408276|OTHER||Geometric Mean Ratio (GMR)|1.21|||||TWO_SIDED|90.0|0.9|1.62||||||||1.62|0.90|
72446201|NCT02515773|144408297|SUPERIORITY||Mean Difference (Net)|0.08|||<|0.001|TWO_SIDED|||||This is a calculated p-value less than 0.001|ANCOVA|||||||<0.001
72446202|NCT02515773|144408298|SUPERIORITY||Mean Difference (Net)|0.07||||0.044|TWO_SIDED||||||ANCOVA|||||||0.044
72446203|NCT02515773|144408299|SUPERIORITY||Mean Difference (Net)|0.08|||<|0.001|TWO_SIDED|||||This is a calculated p-value less than 0.001|ANCOVA|||||||<0.001
72446204|NCT02515773|144408300|SUPERIORITY||Mean Difference (Net)|0.09||||0.041|TWO_SIDED||||||ANCOVA|||||||0.041
72446205|NCT04749615|144408413|NON_INFERIORITY|Noninferiority Margin = (-Infinity, 1.28)||||||0.11|||||||t-test, 1 sided|||||||0.11
72446206|NCT04749615|144408414|NON_INFERIORITY|a noninferiority margin of 1.0 and 10% attrition|Mean Difference (Final Values)|0.05||||0.5|TWO_SIDED|95.0||||this is the calculated p-value.|t-test, 2 sided|||||||0.5
72446207|NCT03736720|144408441|OTHER|No statistical test.|Proportion|0.091|||||TWO_SIDED|80.0|0.033|0.301|||||Estimated using Jeffrey's prior method.|||0.301|0.033|
72619352|NCT01507103|144769358|SUPERIORITY_OR_OTHER||Effect estimate|-0.19||||0.654|TWO_SIDED|95.0|-0.69|0.31||Arm effect|type III SS F-test|||Category: CD8+/GrB+ The difference between baseline and surgical tumor samples was analysed and compared across the 3 treatment arms (effect estimate for Arm B vs Arm C) based on an ANCOVA model. Difference from baseline = Surgery value-Baseline value. Adjustment was based on ANCOVA model with treatment arm as factor and baseline value as covariate. No interaction included. Pairwise tests have been performed to compare Arm A with Arm C, Arm B with Arm C, and Arm A with Arm B||0.31|-0.69|0.654
72389905|NCT00114530|144287743|SUPERIORITY|||||||0.001|||||||Kruskal-Wallis|Computed as Mantel Haenszel Chi Square using modified ridit scores.||Physical Component Score. This analysis is not stratified. EFS survivors and failures are pooled within each treatment arm.||||0.001
72497814|NCT00792298|144525823|SUPERIORITY_OR_OTHER||LS Mean Difference: Week 4|-2.3||||0.644|TWO_SIDED|95.0|-12.2|7.5|||Mixed Models Analysis|||A fixed sequential testing procedure assessed statistical significance, beginning with the highest dose. The comparison of suvorexant vs placebo had to be significant at α=0.05 at both Night 1 and Week 4 in order to assess statistical significance of the comparison of suvorexant vs placebo for the next highest dose. If a non-significant result was observed at either time point, the differences between suvorexant and placebo for SE was considered nonsignificant for this and all lower doses.||7.5|-12.2|0.644
72497815|NCT00792298|144525824|SUPERIORITY_OR_OTHER||LS Mean Difference: Night 1|-22.3||||0.007|TWO_SIDED|95.0|-38.3|-6.2|||Mixed Models Analysis|||A fixed sequential testing procedure assessed statistical significance, beginning with the highest dose. The comparison of suvorexant vs placebo had to be significant at α=0.05 at both Night 1 and Week 4 in order to assess statistical significance of the comparison of suvorexant vs placebo for the next highest dose. If a non-significant result was observed at either time point, the differences between suvorexant and placebo for SE was considered nonsignificant for this and all lower doses.||-6.2|-38.3|0.007
72497816|NCT00792298|144525824|SUPERIORITY_OR_OTHER||LS Mean Difference: Week 4|-19.6||||0.024|TWO_SIDED|95.0|-36.6|-2.6|||Mixed Models Analysis|||A fixed sequential testing procedure assessed statistical significance, beginning with the highest dose. The comparison of suvorexant vs placebo had to be significant at α=0.05 at both Night 1 and Week 4 in order to assess statistical significance of the comparison of suvorexant vs placebo for the next highest dose. If a non-significant result was observed at either time point, the differences between suvorexant and placebo for SE was considered nonsignificant for this and all lower doses.||-2.6|-36.6|0.024
72560925|NCT02951195|144652422|SUPERIORITY||LS Mean Difference|14.5||||0.0563|TWO_SIDED|95.0|-3.8|32.9|||Mixed-effects Model for Repeated Measure|||||32.9|-3.8|0.0563
72560926|NCT02951195|144652423|SUPERIORITY||LS Mean Difference|13.6||||0.0012|TWO_SIDED|95.0|5.3|21.9|||Mixed-effects Model for Repeated Measure|||||21.9|5.3|0.0012
72560927|NCT02951195|144652424|SUPERIORITY||LS Mean Difference|14.1||||0.0476|TWO_SIDED|95.0|-2.6|30.9|||ANCOVA|||||30.9|-2.6|0.0476
72560928|NCT02951195|144652424|SUPERIORITY||LS Mean Difference|29.4||||0.0001|TWO_SIDED|95.0|14.8|44.0|||ANCOVA|||||44.0|14.8|0.0001
72560929|NCT02951195|144652424|SUPERIORITY||LS Mean Difference|26.2||||0.0006|TWO_SIDED|95.0|11.3|41.1|||ANCOVA|||||41.1|11.3|0.0006
72389906|NCT00114530|144287743|SUPERIORITY|||||||0.02|||||||Wilcoxon (Mann-Whitney)|Van Elteren extension of the Wilcoxon Rank Sum||Physical Component Score. This analysis is stratified by EFS status.||||0.02
72389907|NCT00114530|144287743|SUPERIORITY|||||||0.05|||||||Kruskal-Wallis|Computed as Mantel Haenszel Chi Square using modified ridit scores.||Mental Component Score. This analysis is not stratified. EFS survivors and failures are pooled within each treatment arm.||||0.05
72389908|NCT00114530|144287743|SUPERIORITY|||||||0.1|||||||Wilcoxon (Mann-Whitney)|Van Elteren extension of the Wilcoxon Rank Sum||Mental Component Score. This analysis is stratified by EFS status.||||0.1
72389909|NCT00114530|144287744|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|Computed as Mantel Haenszel Chi Square using modified ridit scores.||Physical Component Score. This analysis is not stratified. EFS survivors and failures are pooled within each treatment arm.||||<0.001
72389910|NCT00114530|144287744|SUPERIORITY|||||||0.003|||||||Wilcoxon (Mann-Whitney)|Van Elteren extension of the Wilcoxon Rank Sum||Physical Component Score. This analysis is stratified by EFS status.||||0.003
72389911|NCT00114530|144287744|SUPERIORITY|||||||0.02|||||||Kruskal-Wallis|Computed as Mantel Haenszel Chi Square using modified ridit scores.||Mental Component Score. This analysis is not stratified. EFS survivors and failures are pooled within each treatment arm.||||0.02
72389912|NCT00114530|144287744|SUPERIORITY|||||||0.07|||||||Wilcoxon (Mann-Whitney)|Van Elteren extension of the Wilcoxon Rank Sum||Mental Component Score. This analysis is stratified by EFS status.||||0.07
72389913|NCT00114530|144287745|SUPERIORITY|||||||0.08|||||||Kruskal-Wallis|Computed as Mantel Haenszel Chi Square using modified ridit scores.||This analysis is not stratified. EFS survivors and failures are pooled within each treatment arm.||||0.08
72389914|NCT00114530|144287745|SUPERIORITY|||||||0.9|||||||Wilcoxon (Mann-Whitney)|Van Elteren extension of the Wilcoxon Rank Sum||This analysis is stratified by EFS status.||||0.9
72389915|NCT00114530|144287746|SUPERIORITY|||||||0.1|||||||Kruskal-Wallis|Computed as Mantel Haenszel Chi Square using modified ridit scores.||This analysis is not stratified. EFS survivors and failures are pooled within each treatment arm.||||0.1
72389916|NCT00114530|144287746|SUPERIORITY|||||||0.6|||||||Wilcoxon (Mann-Whitney)|Van Elteren extension of the Wilcoxon Rank Sum||This analysis is stratified by EFS status.||||0.6
72389917|NCT00114530|144287747|SUPERIORITY|||||||0.02|||||||Kruskal-Wallis|Computed as Mantel Haenszel Chi Square using modified ridit scores.||This analysis is not stratified. EFS survivors and failures are pooled within each treatment arm.||||0.02
72389918|NCT00114530|144287747|SUPERIORITY|||||||0.3|||||||Wilcoxon (Mann-Whitney)|Van Elteren extension of the Wilcoxon Rank Sum||This analysis is stratified by EFS status.||||0.3
72389919|NCT00114530|144287748|SUPERIORITY|||||||0.03|||||||Kruskal-Wallis|Computed as Mantel Haenszel Chi Square using modified ridit scores.||This analysis is not stratified. EFS survivors and failures are pooled within each treatment arm.||||0.03
72389920|NCT00114530|144287748|SUPERIORITY|||||||0.5|||||||Wilcoxon (Mann-Whitney)|Van Elteren extension of the Wilcoxon Rank Sum||This analysis is stratified by EFS status.||||0.5
72560930|NCT02951195|144652424|SUPERIORITY||LS Mean Difference|4.8||||0.2714|TWO_SIDED|95.0|-11.6|21.2|||Mixed-effects Model for Repeated Measure|||||21.2|-11.6|0.2714
72446208|NCT03736720|144408447|SUPERIORITY|||||||0.289|||||||Sign test|two-sided test.||Comparing the pre-treatment and end of treatment QoL scores.||||0.289
72446209|NCT03194217|144408453|SUPERIORITY||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.7||0.668|TWO_SIDED|95.0|-1.68|1.08|||ANCOVA|||||1.08|-1.68|0.668
72446210|NCT03194217|144408453|SUPERIORITY||Mean Difference (Final Values)|0.88|STANDARD_ERROR_OF_MEAN|0.7||0.213|TWO_SIDED|95.0|-0.5|2.26|||ANCOVA|||||2.26|-0.50|0.213
72446211|NCT03194217|144408453|SUPERIORITY||Mean Difference (Final Values)|-0.39|STANDARD_ERROR_OF_MEAN|0.7||0.575|TWO_SIDED|95.0|-1.76|0.98|||ANCOVA|||||0.98|-1.76|0.575
72446212|NCT05894577|144408456|SUPERIORITY|Posterior probability of efficacy (P(HR\>1))|Hazard Ratio (HR)|1.02|||||TWO_SIDED|95.0|0.92|1.12|||||The interval is a highest-density credible interval. Adjustment variables: randomization, age, sex, duration of symptoms prior to study drug, calendar time, vaccination status, geographic region, call center indicator, and baseline symptom severity.|||1.12|0.92|
72446213|NCT05894577|144408457|SUPERIORITY||Hazard Ratio (HR)|1.0|||||TWO_SIDED|95.0|0.14|7.07|||||Low event rate precluded covariate adjustment.|No hypothesis test or decision rule was evaluated.||7.07|0.14|
72446214|NCT05894577|144408460|SUPERIORITY|Posterior probability of efficacy (P(HR\<1))|Hazard Ratio (HR)|1.01|||||TWO_SIDED|95.0|0.45|1.84|||||The interval is a highest-density credible interval. Adjustment variables: randomization, age, sex, duration of symptoms prior to study drug, calendar time, vaccination status, geographic region, call center indicator, and baseline symptom severity.|No hypothesis test or decision rule was evaluated.||1.84|0.45|
72446215|NCT05894577|144408461|SUPERIORITY|Posterior probability of efficacy (P(OR\<1))|Odds Ratio (OR)|1.31|||||TWO_SIDED|95.0|0.5|2.29|||||The interval is a highest-density credible interval. Adjustment variables: randomization, age, sex, duration of symptoms prior to study drug, calendar time, vaccination status, geographic region, call center indicator, and baseline symptom severity.|No hypothesis test or decision rule was evaluated.||2.29|0.50|
72446216|NCT05894577|144408462|SUPERIORITY|Posterior probability of efficacy (P(OR\<1))|Odds Ratio (OR)|0.71|||||TWO_SIDED|95.0|0.16|1.49|||||The interval is a highest-density credible interval. Adjustment variables: randomization, age, sex, duration of symptoms prior to study drug, calendar time, vaccination status, geographic region, call center indicator, and baseline symptom severity.|No hypothesis test or decision rule was evaluated.||1.49|0.16|
72446217|NCT05894577|144408463|SUPERIORITY|Posterior probability of efficacy (P(OR\<1))|Odds Ratio (OR)|1.48|||||TWO_SIDED|95.0|0.33|2.96|||||The interval is a highest-density credible interval. Adjustment variables: randomization, age, sex, duration of symptoms prior to study drug, calendar time, vaccination status, geographic region, call center indicator, and baseline symptom severity.|No hypothesis test or decision rule was evaluated.||2.96|0.33|
72446218|NCT05894577|144408464|OTHER||Odds Ratio (OR)|0.96|||||TWO_SIDED|95.0|0.71|1.31|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 7||1.31|0.71|
72446219|NCT05894577|144408464|OTHER||Odds Ratio (OR)|1.06|||||TWO_SIDED|95.0|0.75|1.51|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 14||1.51|0.75|
72446220|NCT05894577|144408464|OTHER||Odds Ratio (OR)|1.26|||||TWO_SIDED|95.0|0.84|1.88|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 28||1.88|0.84|
72446221|NCT05894577|144408464|OTHER||Odds Ratio (OR)|1.02|||||TWO_SIDED|95.0|0.65|1.6|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 90||1.60|0.65|
72446222|NCT05894577|144408464|OTHER||Odds Ratio (OR)|0.88|||||TWO_SIDED|95.0|0.57|1.36|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 120||1.36|0.57|
72446223|NCT05894577|144408464|OTHER||Odds Ratio (OR)|1.18|||||TWO_SIDED|95.0|0.69|2.0|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 180||2.00|0.69|
72446224|NCT05894577|144408465|OTHER||Odds Ratio (OR)|0.87|||||TWO_SIDED|95.0|0.66|1.15|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 7||1.15|0.66|
72446225|NCT05894577|144408465|OTHER||Odds Ratio (OR)|0.84|||||TWO_SIDED|95.0|0.63|1.14|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 14||1.14|0.63|
72446226|NCT05894577|144408465|OTHER||Odds Ratio (OR)|0.78|||||TWO_SIDED|95.0|0.56|1.08|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 28||1.08|0.56|
72446227|NCT05894577|144408465|OTHER||Odds Ratio (OR)|1.03|||||TWO_SIDED|95.0|0.73|1.45|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 90||1.45|0.73|
72446228|NCT05894577|144408465|OTHER||Odds Ratio (OR)|1.0|||||TWO_SIDED|95.0|0.71|1.4|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 120||1.40|0.71|
72560931|NCT02951195|144652425|SUPERIORITY||LS Mean Difference|11.3||||0.0138|TWO_SIDED|95.0|1.3|21.2|||Mixed-effects Model for Repeated Measure|||||21.2|1.3|0.0138
72560932|NCT04542694|144652462|SUPERIORITY||The difference in proportions|0.1313||||0.0372|TWO_SIDED|95.0|-0.0004|0.2367|||Chi-squared|||A comparative analysis of the rate of clinical status improvement by 2 or more categories. The difference in percentages between the AREPLIVIR arm and the standard therapy arm (pa-pb)||0.2367|-0.0004|0.0372
72560933|NCT04542694|144652463|SUPERIORITY||The difference in days|4.0|||<|0.0001|TWO_SIDED||||||Log Rank|||Comparative analysis of time to clinical status improvement by categorical ordinal clinical improvement scale between the AREPLIVIR arm and the standard therapy arm||||<0.0001
72389921|NCT00114530|144287749|SUPERIORITY|||||||0.002|||||||Kruskal-Wallis|Computed as Mantel Haenszel Chi Square using modified ridit scores.||This analysis is not stratified. EFS survivors and failures are pooled within each treatment arm.||||0.002
72389922|NCT00114530|144287749|SUPERIORITY|||||||0.05|||||||Wilcoxon (Mann-Whitney)|Van Elteren extension of the Wilcoxon Rank Sum||This analysis is stratified by EFS status.||||0.05
72389923|NCT00114530|144287750|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|Computed as Mantel Haenszel Chi Square using modified ridit scores.||This analysis is not stratified. EFS survivors and failures are pooled within each treatment arm.||||<0.001
72389924|NCT00114530|144287750|SUPERIORITY|||||||0.01|||||||Wilcoxon (Mann-Whitney)|Van Elteren extension of the Wilcoxon Rank Sum||This analysis is stratified by EFS status.||||0.01
72389925|NCT00114530|144287751|SUPERIORITY|||||||0.42|||||||Chi-squared|||Development of new or worsening arrhythmias||||0.42
72389926|NCT00114530|144287751|SUPERIORITY|||||||0.048|||||||Chi-squared|||CHF requiring clinical treatment||||0.048
72389927|NCT00114530|144287751|SUPERIORITY|||||||0.51|||||||Chi-squared|||Clinically significant pericardial effusion||||0.51
72389928|NCT00114530|144287752|SUPERIORITY|||||||0.46|||||||Chi-squared|||Development of new or worsening arrhythmias||||0.46
72389929|NCT00114530|144287752|SUPERIORITY|||||||0.042|||||||Chi-squared|||CHF requiring clinical treatment||||0.042
72389930|NCT00114530|144287752|SUPERIORITY|||||||0.15|||||||Chi-squared|||Clinically significant pericardial effusion||||0.15
72389931|NCT00114530|144287753|SUPERIORITY|||||||0.026|||||||Chi-squared|||||||0.026
72389932|NCT00114530|144287754|SUPERIORITY|||||||0.022|||||||Chi-squared|||||||0.022
72389933|NCT00114530|144287755|SUPERIORITY|||||||0.71|||||||Chi-squared|||||||0.71
72389934|NCT00114530|144287756|SUPERIORITY|||||||0.32|||||||Chi-squared|||||||0.32
72446229|NCT05894577|144408465|OTHER||Odds Ratio (OR)|0.9|||||TWO_SIDED|95.0|0.6|1.35|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 180||1.35|0.60|
72446230|NCT05894577|144408466|OTHER||Odds Ratio (OR)|0.95|||||TWO_SIDED|95.0|0.7|1.31|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 7||1.31|0.70|
72446231|NCT05894577|144408466|OTHER||Odds Ratio (OR)|1.0|||||TWO_SIDED|95.0|0.72|1.4|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 14||1.40|0.72|
72446232|NCT05894577|144408466|OTHER||Odds Ratio (OR)|0.81|||||TWO_SIDED|95.0|0.55|1.2|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 28||1.20|0.55|
72560934|NCT04542694|144652464|SUPERIORITY||The difference in percentages|22.5||||0.00016|TWO_SIDED||||||Chi-squared|||||||0.00016
72560935|NCT04542694|144652465|SUPERIORITY||Median Difference (Final Values)|1.55||||0.052|TWO_SIDED||||||Log Rank|||||||0.052
72560936|NCT04542694|144652466|SUPERIORITY|||||||0.1953|||||||Chi-squared|||||||0.1953
72560937|NCT04542694|144652467|SUPERIORITY|||||||0.4975|||||||Chi-squared|||||||0.4975
72560938|NCT04561115|144652497|EQUIVALENCE|The relative alpha level for statistical significance was 0.1 (alpha=0.05 for one-sided test), or a 90% CI was used for the bioequivalence test.|Geometric Least Square Mean Ratio|0.948|||||TWO_SIDED|90.0|0.926|0.972||||||||0.972|0.926|
72560939|NCT04561115|144652498|EQUIVALENCE|The relative alpha level for statistical significance was 0.1 (alpha=0.05 for one-sided test), or a 90% CI was used for the bioequivalence test.|Geometric Least Square Mean Ratio|0.978|||||TWO_SIDED|90.0|0.937|1.021||||||||1.021|0.937|
72560940|NCT01332968|144652531|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.66||||0.0012|TWO_SIDED|95.0|0.51|0.85|||Log Rank|Stratified by chemotherapy regimen and Follicular Lymphoma International Prognostic Index (FLIPI) risk group.||||0.85|0.51|0.0012
72560941|NCT01332968|144652532|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.77||||0.0055|TWO_SIDED|95.0|0.64|0.93|||Log Rank|Stratified by chemotherapy regimen and Follicular Lymphoma International Prognostic Index (FLIPI) risk group.||||0.93|0.64|0.0055
72560942|NCT01332968|144652533|SUPERIORITY||Hazard Ratio (HR)|0.77||||0.0028|TWO_SIDED|95.0|0.65|0.91|||Log Rank|||||0.91|0.65|0.0028
72560943|NCT01332968|144652534|SUPERIORITY||Hazard Ratio (HR)|0.72||||0.0118|TWO_SIDED|95.0|0.56|0.93|||Log Rank|||||0.93|0.56|0.0118
72560944|NCT01332968|144652535|SUPERIORITY||Hazard Ratio (HR)|0.71||||0.0038||95.0|0.57|0.9|||Log Rank|||||0.90|0.57|0.0038
72560945|NCT01332968|144652536|SUPERIORITY||Absolute difference in %|1.8||||0.3|TWO_SIDED|95.0|-2.02|5.68|||Log Rank|||Without PET||5.68|-2.02|0.30
72560946|NCT01332968|144652536|SUPERIORITY||Absolute difference in %|4.3||||0.17|TWO_SIDED|95.0|-1.8|10.5|||Log Rank|||With PET||10.5|-1.8|0.17
72560947|NCT01332968|144652537|SUPERIORITY||Absolute difference in %|1.6||||0.33|TWO_SIDED|95.0|-2.0|5.3|||Log Rank|||Without PET||5.3|-2.0|0.33
72560948|NCT01332968|144652537|SUPERIORITY||Absolute difference in %|3.5||||0.17|TWO_SIDED|95.0|-2.3|9.4|||Log Rank|||With PET||9.4|-2.3|0.17
72497817|NCT00792298|144525824|SUPERIORITY_OR_OTHER||LS Mean Difference: Night 1|-31.0|||<|0.001|TWO_SIDED|95.0|-46.9|-15.2|||Mixed Models Analysis|||A fixed sequential testing procedure assessed statistical significance, beginning with the highest dose. The comparison of suvorexant vs placebo had to be significant at α=0.05 at both Night 1 and Week 4 in order to assess statistical significance of the comparison of suvorexant vs placebo for the next highest dose. If a non-significant result was observed at either time point, the differences between suvorexant and placebo for SE was considered nonsignificant for this and all lower doses.||-15.2|-46.9|<0.001
72389935|NCT00114530|144287757|SUPERIORITY|||||||0.3|||||||Chi-squared|||||||0.30
72389936|NCT00114530|144287758|SUPERIORITY|||||||0.31|||||||Chi-squared|||||||0.31
72389937|NCT00114530|144287759|SUPERIORITY|||||||0.002|||||||Chi-squared|||||||0.002
72389938|NCT00114530|144287760|SUPERIORITY|||||||0.001|||||||Chi-squared|||||||0.001
72389939|NCT00114530|144287761|SUPERIORITY||||||<|0.001|||||||Regression, Linear|P-value comes from a Poisson regression comparing the person-year adjusted event rates between the two treatment groups.||||||<0.001
72389940|NCT00114530|144287761|SUPERIORITY||Person-Time (Years)|174.4|||||TWO_SIDED||||||||The Person-Time (P-T) rates (events/P-T) are as follows: Possibly related = 0.61, Probably related = 0.57, Definitely related = 0.52|||||
72389941|NCT00114530|144287761|SUPERIORITY||Person-Time (Years)|141.3|||||TWO_SIDED||||||||The Person-Time (P-T) rates (events/P-T) are as follows: Possibly related = 0.17, Probably related = 0.09, Definitely related = 0.04|||||
72389942|NCT00114530|144287763|SUPERIORITY|||||||0.7|||||||Regression, Linear|P-value comes from a Poisson regression comparing the person-year adjusted event rates between the two treatment groups.||||||0.7
72389943|NCT00114530|144287763|SUPERIORITY||Person-Time (Years)|174.4|||||TWO_SIDED||||||||The Person-Time (P-T) rate (events/P-T) is 0.76|||||
72389944|NCT00114530|144287763|SUPERIORITY||Person-Time (Years)|141.3|||||TWO_SIDED||||||||The Person-Time (P-T) rate (events/P-T) is 0.80|||||
72389945|NCT00365508|144287766|SUPERIORITY_OR_OTHER|||||||0.05||95.0||||a priori threshold for statistical significance|Chi-squared|||Chi-square was used to examine the relationship between treatment arm and 24-hour point prevalence abstinence at 6-months.||||.05
72389946|NCT05248867|144287782|SUPERIORITY||Rate Difference|59.3|||<|0.0001|TWO_SIDED|95.0|54.7|63.9||P-value was based on Cochran-Mantel-Haenszel (CMH) test stratified by investigator site, toxin use history (for aesthetic purposes), and baseline Facial Wrinkle Scale score at maximum frown after using multiple imputation for missing data.|Cochran-Mantel-Haenszel||Difference: AGN-151586 - Placebo|AGN-151586 vs Placebo||63.9|54.7|<0.0001
72389947|NCT05248867|144287783|SUPERIORITY||Rate Difference|60.2|||<|0.0001|TWO_SIDED|95.0|54.9|65.4||P-value was based on Cochran-Mantel-Haenszel (CMH) test stratified by investigator site, toxin use history (for aesthetic purposes), and baseline Facial Wrinkle Scale score at maximum frown after using multiple imputation for missing data.|Cochran-Mantel-Haenszel||Difference: AGN-151586 - Placebo|AGN-151586 vs Placebo||65.4|54.9|<0.0001
72389948|NCT05248867|144287784|SUPERIORITY||Rate Difference|71.4|||<|0.0001|TWO_SIDED|95.0|66.5|76.2||P-value was based on Cochran-Mantel-Haenszel (CMH) test stratified by investigator site, toxin use history (for aesthetic purposes), and baseline Facial Wrinkle Scale score at maximum frown after using multiple imputation for missing data.|Cochran-Mantel-Haenszel||Difference: AGN-151586 - Placebo|AGN-151586 vs Placebo||76.2|66.5|<0.0001
72389949|NCT05248867|144287789|SUPERIORITY||Rate Difference|72.5|||<|0.0001|TWO_SIDED|95.0|67.4|77.6||P-value was based on Cochran-Mantel-Haenszel (CMH) test stratified by investigator site, toxin use history (for aesthetic purposes), and baseline Facial Wrinkle Scale score at maximum frown after using multiple imputation for missing data.|Cochran-Mantel-Haenszel||Difference: AGN-151586 - Placebo|AGN-151586 vs Placebo||77.6|67.4|<0.0001
72389950|NCT05248867|144287790|SUPERIORITY||Rate Difference|41.9|||<|0.0001|TWO_SIDED|95.0|34.5|49.3||P-value was based on Cochran-Mantel-Haenszel (CMH) test stratified by investigator site, toxin use history (for aesthetic purposes), and baseline Facial Wrinkle Scale score at maximum frown after using multiple imputation for missing data.|Cochran-Mantel-Haenszel||Difference: AGN-151586 - Placebo|AGN-151586 vs Placebo||49.3|34.5|<0.0001
72389951|NCT05248867|144287791|SUPERIORITY||Rate Difference|69.5|||<|0.0001|TWO_SIDED|95.0|63.7|75.3||P-value was based on Cochran-Mantel-Haenszel (CMH) test stratified by investigator site, toxin use history (for aesthetic purposes), and baseline Facial Wrinkle Scale score at maximum frown after using multiple imputation for missing data.|Cochran-Mantel-Haenszel||Difference: AGN-151586 - Placebo|AGN-151586 vs Placebo||75.3|63.7|<0.0001
72389952|NCT05248867|144287792|SUPERIORITY||Rate Difference|58.2|||<|0.0001|TWO_SIDED|95.0|51.3|65.0||P-value was based on Cochran-Mantel-Haenszel (CMH) test stratified by investigator site, toxin use history (for aesthetic purposes), and baseline Facial Wrinkle Scale score at maximum frown after using multiple imputation for missing data.|Cochran-Mantel-Haenszel||Difference: AGN-151586 - Placebo|AGN-151586 vs Placebo||65.0|51.3|<0.0001
72395186|NCT01405456|144297039|SUPERIORITY|||||||0.04|||||||Wilcoxon (Mann-Whitney)|||Change in Intramyocellular Lipid of calf muscles as measured by magnetic resonance spectroscopy from baseline to 6 months||||0.04
72395187|NCT01405456|144297040|SUPERIORITY|||||||0.44|||||||Wilcoxon (Mann-Whitney)|||Change in Flow Mediated Vasodilation (maximum percentage) from baseline to 6 months||||0.44
72395188|NCT01405456|144297041|SUPERIORITY|||||||0.07|||||||t-test, 2 sided|||Mean serum measurements of Potassium||||0.07
72395189|NCT01405456|144297042|SUPERIORITY|||||||0.7|||||||Wilcoxon (Mann-Whitney)|||Change in Hemoglobin A1c from baseline to 6 months||||0.70
72395190|NCT01405456|144297043|SUPERIORITY|||||||0.1|||||||Wilcoxon (Mann-Whitney)|||Change in C-Reactive Protein from baseline to 6 months||||0.10
72395191|NCT01405456|144297044|SUPERIORITY|||||||0.37|||||||t-test, 2 sided|||Change in Plasminogen Activator Inhibitor 1 from baseline to 6 months||||0.37
72395192|NCT01405456|144297045|SUPERIORITY|||||||0.78|||||||Wilcoxon (Mann-Whitney)|||Change in Adiponectin from baseline to 6 months||||0.78
72395193|NCT01405456|144297046|SUPERIORITY|||||||0.1|||||||Wilcoxon (Mann-Whitney)|||Change in IL-6 from baseline to 6 months||||0.10
72395194|NCT01405456|144297047|SUPERIORITY|||||||0.04|||||||t-test, 2 sided|||Change in MCP-1 from baseline to 6 months||||0.04
72395195|NCT00850564|144297048|SUPERIORITY_OR_OTHER||||||<|0.005||95.0|||||Paired t-test|||Paired t-test comparing baseline and 2 week mean overnight growth hormone||||<0.005
72560949|NCT01332968|144652538|SUPERIORITY||Absolute difference in %|-5.5||||0.02|TWO_SIDED|95.0|-10.2|-0.78|||Log Rank|||Without PET||-0.78|-10.2|0.02
72389953|NCT05248867|144287793|SUPERIORITY||Rate Difference|30.1|||<|0.0001|TWO_SIDED|95.0|25.2|35.1||P-value was based on Cochran-Mantel-Haenszel (CMH) test stratified by investigator site, toxin use history (for aesthetic purposes), and baseline Facial Wrinkle Scale score at maximum frown after using multiple imputation for missing data.|Cochran-Mantel-Haenszel||Difference: AGN-151586 - Placebo|AGN-151586 vs Placebo||35.1|25.2|<0.0001
72389954|NCT05248867|144287794|SUPERIORITY||Rate Difference|35.7|||<|0.0001|TWO_SIDED|95.0|30.5|40.9||P-value was based on Cochran-Mantel-Haenszel (CMH) test stratified by investigator site, toxin use history (for aesthetic purposes), and baseline Facial Wrinkle Scale score at maximum frown after using multiple imputation for missing data.|Cochran-Mantel-Haenszel||Difference: AGN-151586 - Placebo|AGN-151586 vs Placebo||40.9|30.5|<0.0001
72389955|NCT05248867|144287795|SUPERIORITY||Rate Difference|52.6|||<|0.0001|TWO_SIDED|95.0|45.2|60.0||P-value was based on Cochran-Mantel-Haenszel (CMH) test stratified by investigator site, toxin use history (for aesthetic purposes), and baseline Facial Wrinkle Scale score at maximum frown after using multiple imputation for missing data.|Cochran-Mantel-Haenszel||Difference: AGN-151586 - Placebo|AGN-151586 vs Placebo||60.0|45.2|<0.0001
72389956|NCT05248867|144287796|SUPERIORITY||Rate Difference|58.6|||<|0.0001|TWO_SIDED|95.0|51.1|66.1||P-value was based on Cochran-Mantel-Haenszel (CMH) test stratified by investigator site, toxin use history (for aesthetic purposes), and baseline Facial Wrinkle Scale score at maximum frown after using multiple imputation for missing data.|Cochran-Mantel-Haenszel||Difference: AGN-151586 - Placebo|AGN-151586 vs Placebo||66.1|51.1|<0.0001
72389957|NCT05248867|144287797|SUPERIORITY||Rate Difference|42.5|||<|0.0001|TWO_SIDED|95.0|34.4|50.6||P-value was based on Cochran-Mantel-Haenszel (CMH) test stratified by investigator site, toxin use history (for aesthetic purposes), and baseline Facial Wrinkle Scale score at maximum frown after using multiple imputation for missing data.|Cochran-Mantel-Haenszel||Difference: AGN-151586 - Placebo|AGN-151586 vs Placebo||50.6|34.4|<0.0001
72389958|NCT05248867|144287798|SUPERIORITY||Rate Difference|70.0|||<|0.0001|TWO_SIDED|95.0|63.7|76.3||P-value was based on Cochran-Mantel-Haenszel (CMH) test stratified by investigator site, toxin use history (for aesthetic purposes), and baseline Facial Wrinkle Scale score at maximum frown after using multiple imputation for missing data.|Cochran-Mantel-Haenszel||Difference: AGN-151586 - Placebo|AGN-151586 vs Placebo||76.3|63.7|<0.0001
72389959|NCT05248867|144287806|SUPERIORITY||Rate Difference|48.8|||<|0.0001|TWO_SIDED|95.0|42.2|55.4||P-value was based on Cochran-Mantel-Haenszel (CMH) test stratified by investigator site, toxin use history (for aesthetic purposes), and baseline Facial Wrinkle Scale score at maximum frown after using multiple imputation for missing data.|Cochran-Mantel-Haenszel||Difference: AGN-151586 - Placebo|AGN-151586 vs Placebo||55.4|42.2|<0.0001
72389960|NCT05248867|144287807|SUPERIORITY||Rate Difference|44.2|||<|0.0001|TWO_SIDED|95.0|38.0|50.4||P-value was based on Cochran-Mantel-Haenszel (CMH) test stratified by investigator site, toxin use history (for aesthetic purposes), and baseline Facial Wrinkle Scale score at maximum frown after using multiple imputation for missing data.|Cochran-Mantel-Haenszel||Difference: AGN-151586 - Placebo|AGN-151586 vs Placebo||50.4|38.0|<0.0001
72389961|NCT01064310|144287809|SUPERIORITY_OR_OTHER||Percentage of participants|49.26|||<|0.001|TWO_SIDED|90.0|37.0|61.5||The p value indicates the difference in preference for pazopanib versus sunitinib treatment|Prescotts test||The estimated value indicates the difference in the percentage of participants who preferred pazopanib versus sunitinib. This difference is adjusted for sequence.|||61.5|37.0|<0.001
72389962|NCT01980940|144287820|SUPERIORITY_OR_OTHER_LEGACY||Treatment ratio|5.09|||||TWO_SIDED|90.0|4.03|6.42|||ANOVA|||The geometric least squares mean ratio (GLSMR) and 90% confidence interval was calculated for Cmax after log transformation for the formulation comparison (ETOR 75 DMSO/ETOR 75 PG) using a linear mixed effect model with fixed effects terms for treatment and period and random effect for participants. Cmax with value 0 included in calculation of GLSMs with a value of 0.5\*LLOQ (=0.5 h\*ng/ml).||6.42|4.03|
72389963|NCT01980940|144287820|SUPERIORITY_OR_OTHER_LEGACY||Treatment ratio|7.3|||||TWO_SIDED|90.0|6.05|8.81|||ANOVA|||The GLSMR and 90% confidence interval was calculated for Cmax after log transformation for the formulation comparison (ETOR 150 DMSO/ETOR 150 PG) using a linear mixed effect model with fixed effects terms for treatment and period and random effect for participants. Cmax with value 0 included in calculation of GLSMs with a value of 0.5\*LLOQ (=0.5 h\*ng/ml).||8.81|6.05|
72389964|NCT01980940|144287820|SUPERIORITY_OR_OTHER_LEGACY||Treatment ratio|0.45|||||TWO_SIDED|90.0|0.38|0.55|||ANOVA|||The GLSMR and 90% confidence interval was calculated for Cmax after log transformation for the dose comparison (ETOR 75 DMSO/ETOR 150 DMSO) using a linear mixed effect model with fixed effects terms for treatment and period and random effect for participants. Cmax with value 0 included in calculation of GLSMs with a value of 0.5\*LLOQ (=0.5 h\*ng/ml).||0.55|0.38|
72389965|NCT01980940|144287820|SUPERIORITY_OR_OTHER_LEGACY||Treatment ratio|0.65|||||TWO_SIDED|90.0|0.51|0.83|||ANOVA|||The GLSMR and 90% confidence interval was calculated for Cmax after log transformation for the dose comparison (ETOR 75 PG/ETOR 150 PG) using a linear mixed effect model with fixed effects terms for treatment and period and random effect for participants. Cmax with value 0 included in calculation of GLSMs with a value of 0.5\*LLOQ (=0.5 h\*ng/ml).||0.83|0.51|
72395196|NCT00850564|144297049|SUPERIORITY_OR_OTHER|||||||0.61||95.0|||||Paired t-test|||Paired t-test comparing insulin stimulated glucose uptake (M) between baseline and 2 week visits.||||0.61
72560950|NCT01332968|144652538|SUPERIORITY||Absolute difference in %|5.2||||0.32|TWO_SIDED|95.0|-2.8|13.3|||Log Rank|||With PET||13.3|-2.8|0.32
72560951|NCT01332968|144652539|SUPERIORITY||Absolute difference in %|-4.9||||0.02||95.0|-9.3|0.6|||Log Rank|||Without PET||0.6|-9.3|0.02
72560952|NCT01332968|144652539|SUPERIORITY||Absolute difference in %|4.1||||0.33||95.0|-3.6|11.8|||Log Rank|||With PET||11.8|-3.6|0.33
72560953|NCT01332968|144652540|SUPERIORITY||Absolute difference in %|3.3||||0.052|TWO_SIDED|95.0|-0.19|6.85|||Log Rank|||Without PET||6.85|-0.19|0.052
72560954|NCT01332968|144652540|SUPERIORITY||Absolute difference in %|3.3||||0.3|TWO_SIDED|95.0|-2.3|8.9|||Log Rank|||With PET||8.9|-2.3|0.30
72560955|NCT01332968|144652541|SUPERIORITY||Absolute difference in %|3.2||||0.049|TWO_SIDED|95.0|-0.3|6.6|||Log Rank|||Without PET||6.6|-0.3|0.049
72389966|NCT01980940|144287822|SUPERIORITY_OR_OTHER_LEGACY||Treatment ratio|9.32|||||TWO_SIDED|90.0|4.77|18.18|||ANOVA|||The GLSMR and 90% confidence interval was calculated for AUC0-last after log transformation for the formulation comparison (ETOR 75 DMSO/ETOR 75 PG) using a linear mixed effect model with fixed effects terms for treatment and period and random effect for participants. AUC with value 0 included in calculation of GLSMs with a value of 0.5\*LLOQ (=0.5 h\*ng/ml).||18.18|4.77|
72389967|NCT01980940|144287822|SUPERIORITY_OR_OTHER_LEGACY||Treatment ratio|8.12|||||TWO_SIDED|90.0|6.39|10.32|||ANOVA|||The GLSMR and 90% confidence interval was calculated for AUC0-last after log transformation for the formulation comparison (ETOR 150 DMSO/ETOR 150 PG) using a linear mixed effect model with fixed effects terms for treatment and period and random effect for participants. AUC with value 0 included in calculation of GLSMs with a value of 0.5\*LLOQ (=0.5 h\*ng/ml).||10.32|6.39|
72389968|NCT01980940|144287822|SUPERIORITY_OR_OTHER_LEGACY||Treatment ratio|0.47|||||TWO_SIDED|90.0|0.39|0.57|||ANOVA|||The GLSMR and 90% confidence interval was calculated for AUC0-last after log transformation for the dose comparison (ETOR 75 DMSO/ETOR 150 DMSO) using a linear mixed effect model with fixed effects terms for treatment and period and random effect for participants. AUC with value 0 included in calculation of GLSMs with a value of 0.5\*LLOQ (=0.5 h\*ng/ml).||0.57|0.39|
72389969|NCT01980940|144287822|SUPERIORITY_OR_OTHER_LEGACY||Treatment ratio|0.41|||||TWO_SIDED|90.0|0.21|0.79|||ANOVA|||The GLSMR and 90% confidence interval was calculated for AUC0-last after log transformation for the dose comparison (ETOR 75 PG/ETOR 150 PG) using a linear mixed effect model with fixed effects terms for treatment and period and random effect for participants. AUC with value 0 included in calculation of GLSMs with a value of 0.5\*LLOQ (=0.5 h\*ng/ml).||0.79|0.21|
72389970|NCT01980940|144287823|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-27.3|STANDARD_ERROR_OF_MEAN|21.57||0.2113|TWO_SIDED|90.0|-63.6|8.9|||constrained longitudinal data analysis|||Treatment difference in mean time-weighted average change from baseline to Day 2 in the WOMAC VA 3.1 pain subscale score (ETOR 50 DMSO - Placebo \[Pt 2\]) was evaluated using a constrained longitudinal data analysis model that included baseline measurements and time-weighted average at Day 2 in the response variable. The model included terms of visit, visit-by-treatment, and treatment.||8.9|-63.6|0.2113
72389971|NCT01980940|144287823|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-22.7|STANDARD_ERROR_OF_MEAN|19.66||0.2548|TWO_SIDED|90.0|-55.7|10.3|||constrained longitudinal data analysis|||Treatment difference in mean time-weighted average change from baseline to Day 4 in the WOMAC VA 3.1 pain subscale score (ETOR 50 DMSO - Placebo \[Pt 2\]) was evaluated using a constrained longitudinal data analysis model that included baseline measurements and time-weighted average at Day 4 in the response variable. The model included terms of visit, visit-by-treatment, and treatment.||10.3|-55.7|0.2548
72389972|NCT01980940|144287823|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-21.4|STANDARD_ERROR_OF_MEAN|19.94||0.288|TWO_SIDED|90.0|-54.9|12.0|||constrained longitudinal data analysis|||Treatment difference in mean time-weighted average change from baseline to Day 7 in the WOMAC VA 3.1 pain subscale score (ETOR 50 DMSO - Placebo \[Pt 2\]) was evaluated using a constrained longitudinal data analysis model that included baseline measurements and time-weighted average at Day 7 in the response variable. The model included terms of visit, visit-by-treatment, and treatment.||12.0|-54.9|0.2880
72389973|NCT01980940|144287823|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-17.6|STANDARD_ERROR_OF_MEAN|19.52||0.3709|TWO_SIDED|90.0|-50.4|15.1|||constrained longitudinal data analysis|||Treatment difference in mean time-weighted average change from baseline to Day 11 in the WOMAC VA 3.1 pain subscale score (ETOR 50 DMSO - Placebo \[Pt 2\]) was evaluated using a constrained longitudinal data analysis model that included baseline measurements and time-weighted average at Day 11 in the response variable. The model included terms of visit, visit-by-treatment, and treatment.||15.1|-50.4|0.3709
72389974|NCT01980940|144287823|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-17.3|STANDARD_ERROR_OF_MEAN|19.81||0.3883|TWO_SIDED|90.0|-50.5|16.0|||constrained longitudinal data analysis|||Treatment difference in mean time-weighted average change from baseline to Day 14 in the WOMAC VA 3.1 pain subscale score (ETOR 50 DMSO - Placebo \[Pt 2\]) was evaluated using a constrained longitudinal data analysis model that included baseline measurements and time-weighted average at Day 14 in the response variable. The model included terms of visit, visit-by-treatment, and treatment.||16.0|-50.5|0.3883
72389975|NCT01980940|144287824|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-14.1|STANDARD_ERROR_OF_MEAN|9.32||0.1383|TWO_SIDED|90.0|-29.7|1.6|||constrained longitudinal data analysis|||Treatment difference in mean time-weighted average change from baseline to Day 2 in the WOMAC VA 3.1 stiffness subscale score (ETOR 50 DMSO - Placebo \[Pt 2\]) was evaluated using a constrained longitudinal data analysis model that included baseline measurements and time-weighted average at Day 2 in the response variable. The model included terms of visit, visit-by-treatment, and treatment.||1.6|-29.7|0.1383
72389976|NCT01980940|144287824|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-10.4|STANDARD_ERROR_OF_MEAN|8.66||0.238|TWO_SIDED|90.0|-24.9|4.2|||constrained longitudinal data analysis|||Treatment difference in mean time-weighted average change from baseline to Day 4 in the WOMAC VA 3.1 stiffness subscale score (ETOR 50 DMSO - Placebo \[Pt 2\]) was evaluated using a constrained longitudinal data analysis model that included baseline measurements and time-weighted average at Day 4 in the response variable. The model included terms of visit, visit-by-treatment, and treatment.||4.2|-24.9|0.2380
72389977|NCT01980940|144287824|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-9.5|STANDARD_ERROR_OF_MEAN|8.53||0.2691|TWO_SIDED|90.0|-23.9|4.8|||constrained longitudinal data analysis|||Treatment difference in mean time-weighted average change from baseline to Day 7 in the WOMAC VA 3.1 stiffness subscale score (ETOR 50 DMSO - Placebo \[Pt 2\]) was evaluated using a constrained longitudinal data analysis model that included baseline measurements and time-weighted average at Day 7 in the response variable. The model included terms of visit, visit-by-treatment, and treatment.||4.8|-23.9|0.2691
72446233|NCT05894577|144408466|OTHER||Odds Ratio (OR)|0.92|||||TWO_SIDED|95.0|0.62|1.39|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 90||1.39|0.62|
72446234|NCT05894577|144408466|OTHER||Odds Ratio (OR)|0.98|||||TWO_SIDED|95.0|0.65|1.46|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 120||1.46|0.65|
72446235|NCT05894577|144408466|OTHER||Odds Ratio (OR)|0.81|||||TWO_SIDED|95.0|0.48|1.35|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 180||1.35|0.48|
72446236|NCT05894577|144408467|OTHER||Odds Ratio (OR)|0.88|||||TWO_SIDED|95.0|0.62|1.24|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 7||1.24|0.62|
72446237|NCT05894577|144408467|OTHER||Odds Ratio (OR)|0.95|||||TWO_SIDED|95.0|0.65|1.38|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 14||1.38|0.65|
72446238|NCT05894577|144408467|OTHER||Odds Ratio (OR)|0.74|||||TWO_SIDED|95.0|0.49|1.13|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 28||1.13|0.49|
72446239|NCT05894577|144408467|OTHER||Odds Ratio (OR)|1.02|||||TWO_SIDED|95.0|0.67|1.55|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 90||1.55|0.67|
72446240|NCT05894577|144408467|OTHER||Odds Ratio (OR)|0.78|||||TWO_SIDED|95.0|0.51|1.19|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 120||1.19|0.51|
72446241|NCT05894577|144408467|OTHER||Odds Ratio (OR)|0.81|||||TWO_SIDED|95.0|0.49|1.35|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 180||1.35|0.49|
72497818|NCT00792298|144525824|SUPERIORITY_OR_OTHER||LS Mean Difference: Week 4|-15.7||||0.063|TWO_SIDED|95.0|-32.3|0.8|||Mixed Models Analysis|||A fixed sequential testing procedure assessed statistical significance, beginning with the highest dose. The comparison of suvorexant vs placebo had to be significant at α=0.05 at both Night 1 and Week 4 in order to assess statistical significance of the comparison of suvorexant vs placebo for the next highest dose. If a non-significant result was observed at either time point, the differences between suvorexant and placebo for SE was considered nonsignificant for this and all lower doses.||0.8|-32.3|0.063
72497819|NCT00792298|144525824|SUPERIORITY_OR_OTHER||LS Mean Difference: Night 1|-17.4||||0.03|TWO_SIDED|95.0|-33.1|-1.7|||Mixed Models Analysis|||A fixed sequential testing procedure assessed statistical significance, beginning with the highest dose. The comparison of suvorexant vs placebo had to be significant at α=0.05 at both Night 1 and Week 4 in order to assess statistical significance of the comparison of suvorexant vs placebo for the next highest dose. If a non-significant result was observed at either time point, the differences between suvorexant and placebo for SE was considered nonsignificant for this and all lower doses.||-1.7|-33.1|0.030
72446242|NCT05894577|144408468|OTHER||Odds Ratio (OR)|1.04|||||TWO_SIDED|95.0|0.77|1.41|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 7||1.41|0.77|
72446243|NCT05894577|144408468|OTHER||Odds Ratio (OR)|1.18|||||TWO_SIDED|95.0|0.82|1.69|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 14||1.69|0.82|
72446244|NCT05894577|144408468|OTHER||Odds Ratio (OR)|0.77|||||TWO_SIDED|95.0|0.52|1.14|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 28||1.14|0.52|
72446245|NCT05894577|144408468|OTHER||Odds Ratio (OR)|0.96|||||TWO_SIDED|95.0|0.65|1.43|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 90||1.43|0.65|
72446246|NCT05894577|144408468|OTHER||Odds Ratio (OR)|0.95|||||TWO_SIDED|95.0|0.63|1.41|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 120||1.41|0.63|
72446247|NCT05894577|144408468|OTHER||Odds Ratio (OR)|0.73|||||TWO_SIDED|95.0|0.44|1.19|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 180||1.19|0.44|
72446248|NCT05894577|144408469|OTHER||Odds Ratio (OR)|1.02|||||TWO_SIDED|95.0|0.75|1.39|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 7||1.39|0.75|
72446249|NCT05894577|144408469|OTHER||Odds Ratio (OR)|1.05|||||TWO_SIDED|95.0|0.76|1.44|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 14||1.44|0.76|
72446250|NCT05894577|144408469|OTHER||Odds Ratio (OR)|1.19|||||TWO_SIDED|95.0|0.84|1.71|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 28||1.71|0.84|
72560956|NCT01332968|144652541|SUPERIORITY||Absolute difference in %|3.9||||0.22|TWO_SIDED|95.0|-1.7|9.5|||Log Rank|||With PET||9.5|-1.7|0.22
72446251|NCT05894577|144408469|OTHER||Odds Ratio (OR)|1.14|||||TWO_SIDED|95.0|0.76|1.71|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 90||1.71|0.76|
72446252|NCT05894577|144408469|OTHER||Odds Ratio (OR)|0.99|||||TWO_SIDED|95.0|0.67|1.46|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 120||1.46|0.67|
72446253|NCT05894577|144408469|OTHER||Odds Ratio (OR)|0.99|||||TWO_SIDED|95.0|0.62|1.59|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 180||1.59|0.62|
72446254|NCT05894577|144408470|OTHER||Odds Ratio (OR)|0.92|||||TWO_SIDED|95.0|0.74|1.14|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 7||1.14|0.74|
72446255|NCT05894577|144408470|OTHER||Odds Ratio (OR)|0.98|||||TWO_SIDED|95.0|0.79|1.22|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 14||1.22|0.79|
72446256|NCT05894577|144408470|OTHER||Odds Ratio (OR)|0.87|||||TWO_SIDED|95.0|0.71|1.08|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 28||1.08|0.71|
72497820|NCT00792298|144525824|SUPERIORITY_OR_OTHER||LS Mean Difference: Week 4|-24.6||||0.003|TWO_SIDED|95.0|-41.0|-8.3|||Mixed Models Analysis|||A fixed sequential testing procedure assessed statistical significance, beginning with the highest dose. The comparison of suvorexant vs placebo had to be significant at α=0.05 at both Night 1 and Week 4 in order to assess statistical significance of the comparison of suvorexant vs placebo for the next highest dose. If a non-significant result was observed at either time point, the differences between suvorexant and placebo for SE was considered nonsignificant for this and all lower doses.||-8.3|-41.0|0.003
72497821|NCT00792298|144525824|SUPERIORITY_OR_OTHER||LS Mean Difference: Night 1|-19.1||||0.02|TWO_SIDED|95.0|-35.1|-3.0|||Mixed Models Analysis|||A fixed sequential testing procedure assessed statistical significance, beginning with the highest dose. The comparison of suvorexant vs placebo had to be significant at α=0.05 at both Night 1 and Week 4 in order to assess statistical significance of the comparison of suvorexant vs placebo for the next highest dose. If a non-significant result was observed at either time point, the differences between suvorexant and placebo for SE was considered nonsignificant for this and all lower doses.||-3.0|-35.1|0.020
72497822|NCT00792298|144525824|SUPERIORITY_OR_OTHER||LS Mean Difference: Week 4|-20.2||||0.019|TWO_SIDED|95.0|-37.0|-3.4|||Mixed Models Analysis|||A fixed sequential testing procedure assessed statistical significance, beginning with the highest dose. The comparison of suvorexant vs placebo had to be significant at α=0.05 at both Night 1 and Week 4 in order to assess statistical significance of the comparison of suvorexant vs placebo for the next highest dose. If a non-significant result was observed at either time point, the differences between suvorexant and placebo for SE was considered nonsignificant for this and all lower doses.||-3.4|-37.0|0.019
72497823|NCT04258579|144525832|OTHER|Estimation only.|Mean value at 6 weeks|19.13|||||TWO_SIDED|95.0|15.59|22.67||||||||22.67|15.59|
72446257|NCT05894577|144408470|OTHER||Odds Ratio (OR)|0.98|||||TWO_SIDED|95.0|0.8|1.21|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 90||1.21|0.80|
72446258|NCT05894577|144408470|OTHER||Odds Ratio (OR)|1.04|||||TWO_SIDED|95.0|0.84|1.29|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 120||1.29|0.84|
72446259|NCT05894577|144408470|OTHER||Odds Ratio (OR)|0.88|||||TWO_SIDED|95.0|0.68|1.14|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 180||1.14|0.68|
72446260|NCT05894577|144408471|SUPERIORITY|Posterior probability of efficacy (P(Difference in MTU (Active - Placebo)\<0))|Difference in model estimate time unwell|-0.24|||||TWO_SIDED|95.0|-0.6|0.1|||||The mean time unwell is estimated from receipt of study drug to study day 14. The interval is a highest density credible interval.|No hypothesis test or decision rule was evaluated.||0.1|-0.6|
72446261|NCT05894577|144408472|SUPERIORITY|Posterior probability of efficacy (P(Difference days benefit (Active - Placebo)\>0))|Difference in model estimated means|0.31|||||TWO_SIDED|95.0|-0.13|0.75|||||The interval is a highest density credible interval.|Analysis is exploratory. No hypothesis test or decision rule was evaluated.||0.75|-0.13|
72446262|NCT04509674|144408491|SUPERIORITY||Hazard Ratio (HR)|0.9||||0.2061|TWO_SIDED|95.0|0.76|1.06||"Null hypothesis: there is no difference regarding the risk of the endpoint in question between empagliflozin and placebo.~p\<=0.05 required for testing of subsequent key secondary endpoint hypotheses"|Regression, Cox||Empagliflozin vs. Placebo|The primary endpoint was analysed using a Cox proportional hazards model with treatment, type-2 diabetes at baseline, geographical region, age at baseline, estimated glomerular filtration rate at baseline, left ventricular ejection fraction at baseline, persistent or permanent atrial fibrillation at baseline, prior myocardial infarction at baseline, peripheral artery disease at baseline and smoking at baseline as covariates.||1.06|0.76|0.2061
72560957|NCT01332968|144652542|SUPERIORITY||Absolute difference in %|1.7||||0.58|TWO_SIDED|95.0|-3.5|6.8|||Log Rank|||Without PET||6.8|-3.5|0.58
72560958|NCT01332968|144652542|SUPERIORITY||Absolute difference in %|11.7||||0.006|TWO_SIDED|95.0|3.9|19.4|||Log Rank|||||19.4|3.9|0.006
72560959|NCT01332968|144652543|SUPERIORITY||Absolute difference in %|0.7||||0.8|TWO_SIDED|95.0|-4.0|5.5|||Log Rank|||Without PET||5.5|-4.0|0.80
72446263|NCT04509674|144408492|OTHER|The statistical model used was a negative binomial model, including factors for treatment and type-2 diabetes at baseline, geographical region, age at baseline, estimated glomerular filtration rate at baseline, left ventricular ejection fraction at baseline, persistent or permanent atrial fibrillation at baseline, prior myocardial infarction at baseline, peripheral artery disease at baseline and smoking at baseline as covariates. The log(observation time) was used as an offset variable.|Adjusted event rate ratio|0.87||||0.2423|TWO_SIDED|95.0|0.68|1.1|||Negative binomial regression||Empagliflozin vs. Placebo|||1.10|0.68|0.2423
72446264|NCT04509674|144408493|OTHER|The statistical model used was a negative binomial model, including factors for treatment and type-2 diabetes at baseline, geographical region, age at baseline, estimated glomerular filtration rate at baseline, left ventricular ejection fraction at baseline, persistent or permanent atrial fibrillation at baseline, prior myocardial infarction at baseline, peripheral artery disease at baseline and smoking at baseline as covariates. The log(observation time) was used as an offset variable.|Adjusted event rate ratio|0.92||||0.2867|TWO_SIDED|95.0|0.78|1.07|||Negative binomial regression||Empagliflozin vs. Placebo|||1.07|0.78|0.2867
72446265|NCT04509674|144408494|OTHER|The statistical model used was a negative binomial model, including factors for treatment and type-2 diabetes at baseline, geographical region, age at baseline, estimated glomerular filtration rate at baseline, left ventricular ejection fraction at baseline, persistent or permanent atrial fibrillation at baseline, prior myocardial infarction at baseline, peripheral artery disease at baseline and smoking at baseline as covariates. The log(observation time) was used as an offset variable.|Adjusted event rate ratio|0.87||||0.0463|TWO_SIDED|95.0|0.7654|0.9978|||Negative binomial regression||Empagliflozin vs. Placebo|||0.9978|0.7654|0.0463
72446266|NCT04509674|144408495|OTHER|The statistical model used was a negative binomial model, including factors for treatment and type-2 diabetes at baseline, geographical region, age at baseline, estimated glomerular filtration rate at baseline, left ventricular ejection fraction at baseline, persistent or permanent atrial fibrillation at baseline, prior myocardial infarction at baseline, peripheral artery disease at baseline and smoking at baseline as covariates. The log(observation time) was used as an offset variable.|Adjusted event rate ratio|1.06||||0.6311|TWO_SIDED|95.0|0.83|1.35|||Negative binomial regression||Empagliflozin vs. Placebo|||1.35|0.83|0.6311
72446267|NCT04509674|144408496|OTHER|The statistical analysis was performed using a Cox proportional hazards model with treatment, type-2 diabetes at baseline, geographical region, age at baseline, estimated glomerular filtration rate at baseline, left ventricular ejection fraction at baseline, persistent or permanent atrial fibrillation at baseline, prior myocardial infarction at baseline, peripheral artery disease at baseline and smoking at baseline as covariates.|Hazard Ratio (HR)|1.03||||0.8124||95.0|0.81|1.31|||Regression, Cox||Empagliflozin vs. Placebo|||1.31|0.81|0.8124
72446268|NCT03721952|144408504|SUPERIORITY||Avg. Intervention Effect (CON--INT)|0.13|STANDARD_ERROR_OF_MEAN|0.323||0.688|TWO_SIDED|95.0|-0.505|0.764|||Mixed Models Analysis|Linear mixed-effects: 1-, 3-, 6-mo outcomes, intervention \& time predictors. Primary analysis: avg control-intervention effect over 3 time points.|Additional estimation information: Positive sign of estimate defined as lower average depression score \& negative sign of estimate defined as higher average depression score, over 3 follow-up points for the intervention group vs. the control group.|Superior outcome for Group2 (Facilitator-based INTERVENTION: Family)||0.764|-0.505|0.688
72446269|NCT03721952|144408504|SUPERIORITY|||||||0.51|||||||Mixed Models Analysis|Average Intervention effect with time interaction (control-intervention)||||||0.510
72560960|NCT01332968|144652543|SUPERIORITY||Absolute difference in %|10.1||||0.009||95.0|2.6|17.6|||Log Rank|||With PET||17.6|2.6|0.009
72619353|NCT01507103|144769358|SUPERIORITY_OR_OTHER||Effect estimate|0.21||||0.654|TWO_SIDED|95.0|-0.31|0.74||Arm effect|type III SS F-test|||Category: CD8+/GrB+ The difference between baseline and surgical tumor samples was analysed and compared across the 3 treatment arms (effect estimate for Arm A vs Arm B) based on an ANCOVA model. Difference from baseline = Surgery value-Baseline value. Adjustment was based on ANCOVA model with treatment arm as factor and baseline value as covariate. No interaction included. Pairwise tests have been performed to compare Arm A with Arm C, Arm B with Arm C, and Arm A with Arm B||0.74|-0.31|0.654
72446270|NCT03721952|144408505|SUPERIORITY||Avg. Intervention Effect (CON--INT)|0.143|STANDARD_ERROR_OF_MEAN|0.323||0.658|TWO_SIDED|95.0|-0.491|0.777|||Mixed Models Analysis|Linear mixed-effects: 1-, 3-, 6-mo outcomes, intervention \& time predictors. Primary analysis: avg control-intervention effect over 3 time points.|Additional estimation information: Positive sign of estimate defined as lower average anxiety score \& negative sign of estimate defined as higher average anxiety score, over 3 follow-up points for the intervention group vs. the control group.|Superior outcome for Group2 (Facilitator-based INTERVENTION: Family)||0.777|-0.491|0.658
72446271|NCT03721952|144408505|SUPERIORITY|||||||0.268|||||||Mixed Models Analysis|Average Intervention effect with time interaction (control-intervention)||||||0.268
72446272|NCT03721952|144408506|SUPERIORITY||Avg. Intervention Effect (CON--INT)|-0.2|STANDARD_ERROR_OF_MEAN|0.077||0.01|TWO_SIDED|95.0|-0.353|-0.048|||Mixed Models Analysis|Linear mixed-effects: 1-, 3-, 6-mo outcomes, intervention \& time predictors. Primary analysis: avg control-intervention effect over 3 time points.|Additional information: Positive sign of estimate defined as lower average quality-of-relationship score \& negative sign of estimate defined as higher average quality-of-relationship score over 3 follow-up points for intervention vs control groups.|Superior outcome for Group 2 (Facilitator-based INTERVENTION: Family)||-0.048|-0.353|0.010
72446273|NCT03721952|144408506|SUPERIORITY|||||||0.175|||||||Mixed Models Analysis|Average Intervention effect with time interaction (control-intervention)||||||0.175
72497824|NCT04258579|144525832|OTHER|Estimation only.|Mean value at 9 weeks|16.87|||||TWO_SIDED|95.0|12.5|21.24||||||||21.24|12.50|
72497825|NCT04258579|144525832|OTHER|Estimation only.|Mean value at 12 weeks|15.0|||||TWO_SIDED|95.0|11.24|18.76||||||||18.76|11.24|
72560961|NCT01332968|144652544|SUPERIORITY||Hazard Ratio (HR)|0.86||||0.3577||95.0|0.63|1.18|||Log Rank|||||1.18|0.63|0.3577
72560962|NCT01332968|144652545|SUPERIORITY||Hazard Ratio (HR)|0.82||||0.25||95.0|0.58|1.16|||Log Rank|||||1.16|0.58|0.25
72560963|NCT01332968|144652546|SUPERIORITY||Hazard Ratio (HR)|0.74||||0.0015|TWO_SIDED|95.0|0.62|0.89|||Log Rank|||||0.89|0.62|0.0015
72560964|NCT01332968|144652547|SUPERIORITY||Hazard Ratio (HR)|0.69||||0.0004||95.0|0.56|0.85|||Log Rank|||||0.85|0.56|0.0004
72560965|NCT01332968|144652548|SUPERIORITY||Hazard Ratio (HR)|0.95|||||TWO_SIDED|95.0|0.71|1.27|||Log Rank|||||1.27|0.71|
72560966|NCT01332968|144652549|SUPERIORITY||Hazard Ratio (HR)|0.78|||||TWO_SIDED|95.0|0.5|1.19||||||||1.19|0.50|
72446274|NCT03721952|144408507|SUPERIORITY||Avg. Intervention Effect (CON--INT)|-0.021|STANDARD_ERROR_OF_MEAN|0.092||0.817|TWO_SIDED|95.0|-0.203|0.16|||Mixed Models Analysis|Linear mixed-effects: 1-, 3-, 6-mo outcomes, intervention \& time predictors. Primary analysis: avg control-intervention effect over 3 time points.|Additional information: Positive sign of estimate defined as lower average quality-of-relationship score \& negative sign of estimate defined as higher average quality-of-relationship score, over 3 follow-up points for intervention vs control group.|Superior outcome for Group 2 (Facilitator-based INTERVENTION: Family)||0.160|-0.203|0.817
72446275|NCT03721952|144408507|SUPERIORITY|||||||0.949|||||||Mixed Models Analysis|Average Intervention effect with time interaction (control-intervention)||||||0.949
72446276|NCT03721952|144408508|SUPERIORITY||Avg. Intervention Effect (CON--INT)|-0.45|STANDARD_ERROR_OF_MEAN|0.239||0.06|TWO_SIDED|95.0|-0.919|0.02|||Mixed Models Analysis|Linear mixed-effects: 1-, 3-, 6-mo outcomes, intervention \& time predictors. Primary analysis: avg control-intervention effect over 3 time points.|Additional information: Positive sign of estimate defined as lower average preparation score \& negative sign of estimate defined as higher average preparation score, over 3 follow-up points for intervention vs control group.|Superior outcome for Group 2 (Facilitator-based INTERVENTION: Family)||0.020|-0.919|0.060
72446277|NCT03721952|144408508|SUPERIORITY|||||||0.701|||||||Mixed Models Analysis|Average Intervention effect with time interaction (control-intervention)||||||0.701
72446278|NCT03721952|144408509|SUPERIORITY||Avg. Intervention Effect (CON--INT)|-0.393||||0.053|TWO_SIDED|95.0|-0.791|0.005|||Mixed Models Analysis|Linear mixed-effects: 1-, 3-, 6-mo outcomes, intervention \& time predictors. Primary analysis: avg control-intervention effect over 3 time points.|Additional estimation information: Positive sign of estimate defined as lower average goal-concordant care \& negative sign of estimate defined as higher average goal-concordant care, over 3 follow-up points for intervention group vs. control group.|Superior outcome for Group 2 (Facilitator-based INTERVENTION: Family)||0.005|-0.791|0.053
72446279|NCT03721952|144408509|SUPERIORITY|||||||0.039|||||||Mixed Models Analysis|Average Intervention effect with time interaction (control-intervention)||||||0.039
72446280|NCT03721952|144408510|SUPERIORITY||Avg. Intervention Effect (CON--INT)|0.636||||0.239|TWO_SIDED|95.0|-0.425|1.7|||Mixed Models Analysis|Linear mixed-effects: 1-, 3-, 6-mo outcomes, intervention \& time predictors. Primary analysis: avg control-intervention effect over 3 time points.||Superior outcome for Group2 (Facilitator-based INTERVENTION: Family)||1.700|-0.425|0.239
72446281|NCT03721952|144408510|SUPERIORITY|||||||0.17|||||||Mixed Models Analysis|Average Intervention effect with time interaction (control-intervention)||||||0.170
72497826|NCT04258579|144525833|OTHER|Estimation only.|Mean value at 6 weeks, Domain 1|22.1|||||TWO_SIDED|95.0|19.7|24.5||||||||24.50|19.70|
72560967|NCT01332968|144652550|SUPERIORITY||Hazard Ratio (HR)|0.76|||||TWO_SIDED|95.0|0.63|0.93|||Log Rank|||||0.93|0.63|
72446282|NCT03721952|144408511|SUPERIORITY||Slope|0.089|STANDARD_ERROR_OF_MEAN|0.041||0.029|TWO_SIDED|95.0|0.009|0.169|||Regression, Linear|Linear regression of outcome on group (0=control, 1=interv), adjusted for hospital, w robust standard error estimate using bias correction 1/(1-h)\^2.|Additional estimation information: Positive sign of estimate defined as higher proportion of readmissions \& negative sign of estimate defined as lower proportion of readmissions, for the intervention group vs. the control group|Superior outcome for Group2 (Patient-Intervention)||0.169|0.009|0.029
72446283|NCT03721952|144408512|SUPERIORITY||Slope|1.078|STANDARD_ERROR_OF_MEAN|0.808||0.183|TWO_SIDED|95.0|-0.511|2.666|||Regression, Linear|Linear regression of outcome on group (0=control, 1=interv), adjusted for hospital, w robust standard error estimate using bias correction 1/(1-h)\^2.|Additional estimation information: Positive sign of estimate defined as higher number of hospital free days \& negative sign of estimate defined as lower number of hospital free days, for the intervention group vs. the control group.|Superior outcome for Group2 (Patient-Intervention)||2.666|-0.511|0.183
72446284|NCT03721952|144408513|SUPERIORITY||Slope|1.687|STANDARD_ERROR_OF_MEAN|3.157||0.593|TWO_SIDED|95.0|-4.518|7.892|||Regression, Linear|Linear regression of outcome on group (0=control, 1=interv), adjusted for hospital, w robust standard error estimate using bias correction 1/(1-h)\^2.|Additional estimation information: Positive sign of estimate defined as higher number of hospital free days \& negative sign of estimate defined as lower number of hospital free days, for the intervention group vs. the control group.|Superior outcome for Group2 (Patient-Intervention)||7.892|-4.518|0.593
72446285|NCT03721952|144408514|SUPERIORITY||Slope|4.365|STANDARD_ERROR_OF_MEAN|6.987||0.533|TWO_SIDED|95.0|-9.367|18.097|||Regression, Linear|Linear regression of outcome on group (0=control, 1=interv), adjusted for hospital, w robust standard error estimate using bias correction 1/(1-h)\^2.|Additional estimation information: Positive sign of estimate defined as higher number of hospital free days \& negative sign of estimate defined as lower number of hospital free days, for the intervention group vs. the control group.|Superior outcome for Group2 (Patient-Intervention)||18.097|-9.367|0.533
72497827|NCT04258579|144525833|OTHER|Estimation only.|Mean value at 6 weeks, Domain 2|19.9|||||TWO_SIDED|95.0|18.0|21.8||||||||21.80|18.00|
72497828|NCT04258579|144525833|OTHER|Estimation only.|Mean value at 6 weeks, Domain 3|8.93|||||TWO_SIDED|95.0|7.68|10.18||||||||10.18|7.68|
72497829|NCT04258579|144525833|OTHER|Estimation only.|Mean value at 6 weeks, Domain 4|26.63|||||TWO_SIDED|95.0|24.32|28.94||||||||28.94|24.32|
72497830|NCT04258579|144525833|OTHER|Estimation only.|Mean value at 9 weeks, Domain 1|22.53|||||TWO_SIDED|95.0|19.87|25.23||||||||25.23|19.87|
72560968|NCT01332968|144652551|SUPERIORITY||Hazard Ratio (HR)|0.69||||||95.0|0.55|0.88||||||||0.88|0.55|
72560969|NCT01332968|144652552|SUPERIORITY||Hazard Ratio (HR)|0.71||||0.001|TWO_SIDED|95.0|0.58|0.87|||Log Rank|||||0.87|0.58|0.001
72560970|NCT01332968|144652553|SUPERIORITY||Hazard Ratio (HR)|0.7||||0.004||95.0|0.54|0.89|||Log Rank|||||0.89|0.54|0.004
72560971|NCT03480022|144652562|SUPERIORITY||||||<|0.002|||||||ANOVA|Nested repeated measures design||Repeated measures general linear model (SS/drug treatments by visits) where arm of drug therapy as between subjects effect and visit (baseline and 32 weeks of treatment) as within subject effect||||<0.002
72497831|NCT04258579|144525833|OTHER|Estimation only.|Mean value at 9 weeks, Domain 2|21.0|||||TWO_SIDED|95.0|18.87|23.13||||||||23.13|18.87|
72497832|NCT04258579|144525833|OTHER|Estimation only.|Mean value at 9 weeks, Domain 3|8.69|||||TWO_SIDED|95.0|7.39|9.99||||||||9.99|7.39|
72497833|NCT04258579|144525833|OTHER|Estimation only.|Mean value at 9 weeks, Domain 4|27.38|||||TWO_SIDED|95.0|25.07|29.69||||||||29.69|25.07|
72446286|NCT03721952|144408515|SUPERIORITY||Slope|1.07|STANDARD_ERROR_OF_MEAN|1.07||0.318|TWO_SIDED|95.0|-1.032|3.173|||Regression, Linear|Linear regression of outcome on group (0=control, 1=interv), adjusted for hospital, w robust standard error estimate using bias correction 1/(1-h)\^2.|Additional estimation information: Positive sign of estimate defined as higher number of ICU free days \& negative sign of estimate defined as lower number of ICU free days, for the intervention group vs. the control group.|Superior outcome for Group2 (Patient-Intervention)||3.173|-1.032|0.318
72446287|NCT03721952|144408516|SUPERIORITY||Slope|4.117|STANDARD_ERROR_OF_MEAN|3.506||0.241|TWO_SIDED|95.0|-2.773|11.007|||Regression, Linear|Linear regression of outcome on group (0=control, 1=interv), adjusted for hospital, w robust standard error estimate using bias correction 1/(1-h)\^2.|Additional estimation information: Positive sign of estimate defined as higher number of ICU free days \& negative sign of estimate defined as lower number of ICU free days, for the intervention group vs. the control group.|Superior outcome for Group2 (Patient-Intervention)||11.007|-2.773|0.241
72446288|NCT03721952|144408517|SUPERIORITY||Slope|8.195|STANDARD_ERROR_OF_MEAN|7.466||0.273|TWO_SIDED|95.0|-6.479|22.868|||Regression, Linear|Linear regression of outcome on group (0=control, 1=interv), adjusted for hospital, w robust standard error estimate using bias correction 1/(1-h)\^2.|Additional estimation information: Positive sign of estimate defined as higher number of ICU free days \& negative sign of estimate defined as lower number of ICU free days, for the intervention group vs. the control group.|Superior outcome for Group2 (Patient-Intervention)||22.868|-6.479|0.273
72446289|NCT03721952|144408518|SUPERIORITY||Slope|-0.0000009|STANDARD_ERROR_OF_MEAN|0.00000248||0.71|TWO_SIDED|95.0|-0.0000057|0.0000039|||other type of regression|Regression \[gamma family, link function g(u)=u-0.9\], outcome on random group (0=control, 1=intervention), adjusted for hospital, robust SEs.||Superior outcome for Group2 (Patient-Intervention)||0.0000039|-0.0000057|0.710
72446290|NCT03721952|144408519|SUPERIORITY||Slope|0.00000113|STANDARD_ERROR_OF_MEAN|0.00000215||0.599|TWO_SIDED|95.0|-0.000003|0.0000053|||other type of regression|Regression \[inverse Gaussian family, link function g(u)=u-0.9\], outcome on random group (0=control,1=intervention), adjusted for hospital, robust SEs.||Superior outcome for Group2 (Patient-Intervention)||0.0000053|-0.0000030|0.599
72446291|NCT01000961|144408612|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The non-inferiority endpoint of the clinical trial would be achieved if the upper limit of the 95.8% CI of the difference between RP103 and Cystagon® was less than the a-priori 0.3 non-inferiority margin, which would correspond to an observed p-value less than or equal to 0.02104|Mean Difference (Final Values)|0.0785||||0.0001|TWO_SIDED|95.8|0.0107|0.1464|||t-test, 1 sided||95.8% confidence interval was used instead of 95% to take into account a sample size re-estimation calculation that was performed after 20 patients were enrolled.|16-subject study will have 90% power to reject the null hypothesis of non-inferiority at the 0.025 level of significance with a non-inferiority margin of 0.3. Final analysis was performed at a nominal significance level of 0.02104.||0.1464|0.0107|0.0001
72446292|NCT01000961|144408613|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|1.4|||||TWO_SIDED|95.0|1.17|1.67||||||||1.67|1.17|
72497834|NCT04258579|144525833|OTHER|Estimation only.|Mean value at 12 weeks, Domain 1|22.62|||||TWO_SIDED|95.0|20.18|25.06||||||||25.06|20.18|
72497835|NCT04258579|144525833|OTHER|Estimation only.|Mean value at 12 weeks, Domain 2|21.58|||||TWO_SIDED|95.0|19.84|23.32||||||||23.32|19.84|
72446293|NCT01000961|144408614|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|105.0|||||TWO_SIDED|95.0|90.0|150.0||||||||150|90|
72446294|NCT01000961|144408615|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.03|||||TWO_SIDED|95.0|1.75|2.39||||||||2.39|1.75|
72446295|NCT05480124|144408649|SUPERIORITY|||||||0.609|||||||t-test, 2 sided|||||||0.609
72446296|NCT05480124|144408651|SUPERIORITY|||||||0.098|||||||t-test, 2 sided|||||||0.098
72446297|NCT05480124|144408652|SUPERIORITY|||||||0.204|||||||t-test, 2 sided|||||||0.204
72446298|NCT05480124|144408653|SUPERIORITY|||||||0.383|||||||t-test, 2 sided|||||||0.383
72446299|NCT05480124|144408654|SUPERIORITY|||||||0.201|||||||t-test, 2 sided|||||||0.201
72446300|NCT03640312|144408671|SUPERIORITY||Mean Difference (Net)|-4.78|STANDARD_ERROR_OF_MEAN|2.97||0.114|TWO_SIDED|95.0|-10.74|1.18||Adjusting for baseline systolic blood pressure.|Mixed Models Analysis|Difference in Least Squared Means (LSM). Random participant effect, fixed baseline, study arm, and time effects.||||1.18|-10.74|0.114
72497836|NCT04258579|144525833|OTHER|Estimation only.|Mean value at 12 weeks, Domain 3|9.19|||||TWO_SIDED|95.0|7.92|10.46||||||||10.46|7.92|
72497837|NCT04258579|144525833|OTHER|Estimation only.|Mean value at 12 weeks, Domain 4|27.81|||||TWO_SIDED|95.0|25.53|30.09||||||||30.09|25.53|
72497838|NCT04258579|144525834|OTHER|Estimation only.|Mean value at baseline|22.45|||||TWO_SIDED|95.0|19.56|25.34||||||||25.34|19.56|
72497839|NCT04258579|144525834|OTHER|Estimation only.|Mean value at 6 weeks|20.53|||||TWO_SIDED|95.0|17.65|23.41||||||||23.41|17.65|
72497840|NCT04258579|144525835|OTHER|Estimation only.|Mean value at baseline, Domain 1|19.89|||||TWO_SIDED|95.0|17.24|22.54||||||||22.54|17.24|
72497841|NCT04258579|144525835|OTHER|Estimation only.|Mean value at baseline, Domain 2|22.46|||||TWO_SIDED|95.0|19.72|25.2||||||||25.20|19.72|
72497842|NCT04258579|144525835|OTHER|Estimation only.|Mean value at baseline, Domain 3|16.0|||||TWO_SIDED|95.0|13.72|18.28||||||||18.28|13.72|
72497843|NCT04258579|144525835|OTHER|Estimation only.|Mean value at baseline, Domain 4|17.79|||||TWO_SIDED|95.0|15.34|20.24||||||||20.24|15.34|
72497844|NCT04258579|144525835|OTHER|Estimation only.|Mean value at 6 weeks, Domain 1|22.79|||||TWO_SIDED|95.0|19.05|26.53||||||||26.53|19.05|
72497845|NCT04258579|144525835|OTHER|Estimation only.|Mean value at 6 weeks, Domain 2|26.7|||||TWO_SIDED|95.0|22.96|30.44||||||||30.44|22.96|
72497846|NCT04258579|144525835|OTHER|Estimation only.|Mean value at 6 weeks, Domain 3|17.45|||||TWO_SIDED|95.0|14.57|20.33||||||||20.33|14.57|
72497847|NCT04258579|144525835|OTHER|Estimation only.|Mean value at 6 weeks, Domain 4|20.69|||||TWO_SIDED|95.0|18.23|23.15||||||||23.15|18.23|
72446301|NCT03640312|144408672|SUPERIORITY|Adjusted for baseline systolic blood pressure.|Mean Difference (Net)|-4.78|STANDARD_ERROR_OF_MEAN|2.97||0.114|TWO_SIDED|95.0|-10.74|1.18|||Mixed Models Analysis|||||1.18|-10.74|0.114
72446302|NCT03640312|144408673|SUPERIORITY||Mean Difference (Net)|-4.86|STANDARD_ERROR_OF_MEAN|1.87||0.012|TWO_SIDED|95.0|-8.62|-1.11||Adjusted Least Squares Mean.|Mixed Models Analysis|||Adjusted for baseline diastolic blood pressure.||-1.11|-8.62|0.012
72446303|NCT03640312|144408674|SUPERIORITY||Mean Difference (Net)|-4.86|STANDARD_ERROR_OF_MEAN|1.87||0.012|TWO_SIDED|95.0|-8.62|-1.11|||Mixed Models Analysis|||||-1.11|-8.62|0.012
72497848|NCT01950819|144525858|NON_INFERIORITY|p vale for non inferiority margin is 10 %|Odds Ratio (OR)|3.0||||0.001|TWO_SIDED|95.0|-1.4|7.3|||Logistic Regression Model|||calculated at month 12||7.3|-1.4|0.001
72560972|NCT03480022|144652563|SUPERIORITY||||||<|0.006|||||||ANOVA|Nested repeated measures design||Repeated measures general linear model (SS/drug treatments by visits) where arm of drug therapy as between subjects effect and visit (baseline and 32 weeks of treatment) as within subject effect||||<0.006
72560973|NCT03480022|144652564|SUPERIORITY||||||<|0.001|||||||ANOVA|Repeated measures nested design||Repeated measures general linear model (SS/drug treatments by visits) where arm of drug therapy as between subjects effect and visit (baseline and 32 weeks of treatment) as within subject effect||||<0.001
72446304|NCT03640312|144408675|SUPERIORITY||Odds Ratio (OR)|2.4||||0.077|TWO_SIDED|95.0|0.91|6.35|||Mixed Models Analysis|Generalized Linear Mixed Model (binomial distribution assumption with logit link).||||6.35|0.91|0.077
72446305|NCT03640312|144408676|SUPERIORITY||Odds Ratio (OR)|0.13||||0.003|TWO_SIDED|95.0|0.03|0.48|||Regression, Logistic|||Logistic regression model adjusting for baseline systolic and diastolic blood pressure.||0.48|0.03|0.003
72446306|NCT03640312|144408677|SUPERIORITY||Odds Ratio (OR)|0.8||||0.71|TWO_SIDED|95.0|0.24|2.69|||Mixed Models Analysis|||Generalized linear mixed model adjusting for baseline systolic and diastolic blood pressure. Random participant effects. Fixed baseline systolic, diastolic, study arm, and time effects.||2.69|0.24|0.710
72446307|NCT03640312|144408678|SUPERIORITY||Odds Ratio (OR)|0.64||||0.437|TWO_SIDED|95.0|0.21|1.98|||Regression, Logistic|||Logistic regression model adjusting for baseline systolic and diastolic blood pressure.||1.98|0.21|0.437
72446308|NCT03640312|144408679|SUPERIORITY||Mean Difference (Net)|-3.45|STANDARD_ERROR_OF_MEAN|2.01||0.09|TWO_SIDED|95.0|-7.49|0.59||Adjusted for baseline T score|ANCOVA|||Statistical test for difference in Physical Health T Score||0.59|-7.49|0.09
72446309|NCT03640312|144408679|SUPERIORITY||Mean Difference (Net)|0.55|STANDARD_ERROR_OF_MEAN|1.88||0.77|TWO_SIDED|95.0|-3.22|4.32||Adjusted for baseline mental health T score|ANCOVA|||Statistical test for difference in Mental Health T Score||4.32|-3.22|0.77
72446310|NCT03640312|144408680|SUPERIORITY||Mean Difference (Net)|-4.78|STANDARD_ERROR_OF_MEAN|2.97||0.114|TWO_SIDED|95.0|-10.74|1.182|||Mixed Models Analysis|||Linear mixed model. Random participant effects. Fixed baseline systolic, study arm, and time effects.||1.182|-10.74|0.114
72446311|NCT03640312|144408681|SUPERIORITY||Risk Difference (RD)|-0.06|STANDARD_ERROR_OF_MEAN|0.04||0.49|TWO_SIDED|95.0|-0.15|0.02|||Fisher Exact|||||0.02|-0.15|0.49
72446312|NCT03640312|144408682|SUPERIORITY||Risk Difference (RD)|-0.15|STANDARD_ERROR_OF_MEAN|0.09||0.21|TWO_SIDED|95.0|-0.33|0.03|||Chi-squared|||||0.03|-0.33|0.21
72446313|NCT03640312|144408683|SUPERIORITY||Risk Difference (RD)|-0.17|STANDARD_ERROR_OF_MEAN|0.12||0.18|TWO_SIDED|95.0|-0.41|0.08|||Chi-squared|||||0.08|-0.41|0.18
72446314|NCT03640312|144408684|SUPERIORITY||Mean Difference (Net)|-0.05|STANDARD_ERROR_OF_MEAN|0.09||0.56|TWO_SIDED|95.0|-0.24|0.13|||Mixed Models Analysis|||||0.13|-0.24|0.56
72446315|NCT03640312|144408685|SUPERIORITY||Mean Difference (Net)|-0.71|STANDARD_ERROR_OF_MEAN|0.45||0.12|TWO_SIDED|95.0|-1.61|0.19||Linear mixed model. Random participant effects. Fixed baseline systolic, study arm, and time effects.|Mixed Models Analysis|||||0.19|-1.61|0.12
72446316|NCT03640312|144408686|SUPERIORITY||Mean Difference (Net)|0.08|STANDARD_ERROR_OF_MEAN|0.95||0.94|TWO_SIDED|95.0|-1.84|1.99||Linear mixed model. Random participant effects. Fixed baseline systolic, study arm, and time effects.|Mixed Models Analysis||The model estimated mean differences, adjusted for covariates, will not be equal to the raw mean differences observed.|||1.99|-1.84|0.94
72446317|NCT03640312|144408687|SUPERIORITY||Mean Difference (Net)|-0.02|STANDARD_ERROR_OF_MEAN|0.03||0.55|TWO_SIDED|95.0|-0.07|0.04||Linear mixed model. Random participant effects. Fixed baseline systolic, study arm, and time effects.|Mixed Models Analysis|||||0.04|-0.07|0.55
72446318|NCT04709783|144408698|OTHER|One group pre-post test.|Median Difference (Final Values)|-2.67||||0.01|ONE_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||.01
72446319|NCT04709783|144408699|OTHER||Median Difference (Final Values)|-2.49||||0.01|ONE_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||0.01
72446320|NCT04709783|144408700|OTHER||Median Difference (Final Values)|-1.84||||0.07|ONE_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||0.07
72446321|NCT04709783|144408701|OTHER||Median Difference (Final Values)|-2.37||||0.02|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||0.02
72560974|NCT03480022|144652565|SUPERIORITY||||||<|0.002|||||||ANOVA|one-way ANOVA||||||<0.002
72560975|NCT03480022|144652566|SUPERIORITY||||||<|0.007|||||||Wilcoxon (Mann-Whitney)|||||||<0.007
72560976|NCT03480022|144652567|SUPERIORITY||||||<|0.049|||||||Wilcoxon (Mann-Whitney)|||||||<0.049
72560977|NCT03480022|144652568|SUPERIORITY||||||<|0.011|||||||ANOVA|Nested repeated measures design||Repeated measures general linear model (SS/drug treatments by visits) where arm of drug therapy as between subjects effect and visit (baseline and 32 weeks of treatment) as within subject effect||||<0.011
72560978|NCT03480022|144652569|SUPERIORITY||||||<|0.038|||||||ANOVA|Nested repeated measures design||Repeated measures general linear model (SS/drug treatments by visits) where arm of drug therapy as between subjects effect and visit (baseline and 32 weeks of treatment) as within subject effect||||<0.038
72560979|NCT03480022|144652570|SUPERIORITY||||||<|0.048|||||||ANOVA|Nested repeated measures design||Repeated measures general linear model (SS/drug treatments by visits) where arm of drug therapy as between subjects effect and visit (baseline and 32 weeks of treatment) as within subject effect||||<0.048
72389978|NCT01980940|144287824|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-8.1|STANDARD_ERROR_OF_MEAN|8.15||0.3246|TWO_SIDED|90.0|-21.8|5.6|||constrained longitudinal data analysis|||Treatment difference in mean time-weighted average change from baseline to Day 11 in the WOMAC VA 3.1 stiffness subscale score (ETOR 50 DMSO - Placebo \[Pt 2\]) was evaluated using a constrained longitudinal data analysis model that included baseline measurements and time-weighted average at Day 11 in the response variable. The model included terms of visit, visit-by-treatment, and treatment.||5.6|-21.8|0.3246
72497849|NCT01879410|144525898|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.101|||<|0.001|TWO_SIDED|95.0|0.063|0.139|||ANCOVA||Least squares mean difference=UMEC/VI 62.5/25 mcg minus FSC 250/50 mcg.|||0.139|0.063|<0.001
72560980|NCT03480022|144652571|SUPERIORITY||||||<|0.018|||||||ANOVA|Nested repeated measures design||Repeated measures general linear model (SS/drug treatments by visits) where arm of drug therapy as between subjects effect and visit (baseline and 32 weeks of treatment) as within subject effect||||<0.018
72619354|NCT01507103|144769359|SUPERIORITY_OR_OTHER||LS Means estimate|-0.03||||0.921|TWO_SIDED|95.0|-0.73|0.67|||type III SS F-test||Difference between Means adjusted on covariates baseline value and MSI category.|Category: CD8+ The difference in T cell infiltration from baseline to surgery was analysed and compared across the 3 treatment arms (effect estimate for Arm A vs Arm C) based on an ANCOVA model. Difference from baseline = Surgery value-Baseline value. Adjustment was based on ANCOVA model with treatment arm as factor and baseline value and MSI category as covariates. No interaction included. Pairwise tests have been performed to compare Arm A with Arm C, Arm B with Arm C, and Arm A with Arm B.||0.67|-0.73|0.921
72389979|NCT01980940|144287824|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-7.1|STANDARD_ERROR_OF_MEAN|8.19||0.3881|TWO_SIDED|90.0|-20.9|6.6|||constrained longitudinal data analysis|||Treatment difference in mean time-weighted average change from baseline to Day 14 in the WOMAC VA 3.1 stiffness subscale score (ETOR 50 DMSO - Placebo \[Pt 2\]) was evaluated using a constrained longitudinal data analysis model that included baseline measurements and time-weighted average at Day 14 in the response variable. The model included terms of visit, visit-by-treatment, and treatment.||6.6|-20.9|0.3881
72389980|NCT01980940|144287825|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-52.3|STANDARD_ERROR_OF_MEAN|68.25||0.4477|TWO_SIDED|90.0|-166.8|62.3|||constrained longitudinal data analysis|||Treatment difference in mean time-weighted average change from baseline to Day 2 in the WOMAC VA 3.1 physical function subscale score (ETOR 50 DMSO - Placebo \[Pt 2\]) was evaluated using a constrained longitudinal data analysis model that included baseline measurements and time-weighted average at Day 2 in the response variable. The model included terms of visit, visit-by-treatment, and treatment.||62.3|-166.8|0.4477
72389981|NCT01980940|144287825|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-33.7|STANDARD_ERROR_OF_MEAN|65.42||0.6084|TWO_SIDED|90.0|-143.6|76.1|||constrained longitudinal data analysis|||Treatment difference in mean time-weighted average change from baseline to Day 4 in the WOMAC VA 3.1 physical function subscale score (ETOR 50 DMSO - Placebo \[Pt 2\]) was evaluated using a constrained longitudinal data analysis model that included baseline measurements and time-weighted average at Day 4 in the response variable. The model included terms of visit, visit-by-treatment, and treatment.||76.1|-143.6|0.6084
72389982|NCT01980940|144287825|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-35.2|STANDARD_ERROR_OF_MEAN|65.25||0.5926|TWO_SIDED|90.0|-144.7|74.4|||constrained longitudinal data analysis|||Treatment difference in mean time-weighted average change from baseline to Day 7 in the WOMAC VA 3.1 physical function subscale score (ETOR 50 DMSO - Placebo \[Pt 2\]) was evaluated using a constrained longitudinal data analysis model that included baseline measurements and time-weighted average at Day 7 in the response variable. The model included terms of visit, visit-by-treatment, and treatment.||74.4|-144.7|0.5926
72389983|NCT01980940|144287825|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-42.3|STANDARD_ERROR_OF_MEAN|62.49||0.5022|TWO_SIDED|90.0|-147.2|62.6|||constrained longitudinal data analysis|||Treatment difference in mean time-weighted average change from baseline to Day 11 in the WOMAC VA 3.1 physical function subscale score (ETOR 50 DMSO - Placebo \[Pt 2\]) was evaluated using a constrained longitudinal data analysis model that included baseline measurements and time-weighted average at Day 11 in the response variable. The model included terms of visit, visit-by-treatment, and treatment.||62.6|-147.2|0.5022
72389984|NCT01980940|144287825|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-42.0|STANDARD_ERROR_OF_MEAN|63.7||0.5125|TWO_SIDED|90.0|-149.0|64.9|||constrained longitudinal data analysis|||Treatment difference in mean time-weighted average change from baseline to Day 14 in the WOMAC VA 3.1 physical function subscale score (ETOR 50 DMSO - Placebo \[Pt 2\]) was evaluated using a constrained longitudinal data analysis model that included baseline measurements and time-weighted average at Day 14 in the response variable. The model included terms of visit, visit-by-treatment, and treatment.||64.9|-149.0|0.5125
72389985|NCT01980940|144287826|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2632|||||||Jonckheere-Terpstra test|||Treatment comparison of Day 2 PGART frequencies (ETOR 50 DMSO vs Placebo \[Pt 2\]) was performed using a two-sided Jonckheere-Terpstra test.||||0.2632
72389986|NCT01980940|144287826|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4703|||||||Jonckheere-Terpstra test|||Treatment comparison of Day 4 PGART frequencies (ETOR 50 DMSO vs Placebo \[Pt 2\]) was performed using a two-sided Jonckheere-Terpstra test.||||0.4703
72389987|NCT01980940|144287826|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5507|||||||Jonckheere-Terpstra test|||Treatment comparison of Day 7 PGART frequencies (ETOR 50 DMSO vs Placebo \[Pt 2\]) was performed using a two-sided Jonckheere-Terpstra test.||||0.5507
72389988|NCT01980940|144287826|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3992|||||||Jonckheere-Terpstra test|||Treatment comparison of Day 11 PGART frequencies (ETOR 50 DMSO vs Placebo \[Pt 2\]) was performed using a two-sided Jonckheere-Terpstra test.||||0.3992
72560981|NCT03480022|144652572|SUPERIORITY||||||<|0.028|||||||ANOVA|Nested repeated measures design||Repeated measures general linear model (SS/drug treatments by visits) where arm of drug therapy as between subjects effect and visit (baseline and 32 weeks of treatment) as within subject effect||||<0.028
72560982|NCT03480022|144652573|SUPERIORITY||||||<|0.034|||||||ANOVA|Nested repeated measures design||Repeated measures general linear model (SS/drug treatments by visits) where arm of drug therapy as between subjects effect and visit (baseline and 32 weeks of treatment) as within subject effect||||<0.034
72560983|NCT03480022|144652574|SUPERIORITY||||||<|0.035|||||||ANOVA|Nested repeated measures design||Repeated measures general linear model (SS/drug treatments by visits) where arm of drug therapy as between subjects effect and visit (baseline and 32 weeks of treatment) as within subject effect||||<0.035
72560984|NCT03480022|144652575|SUPERIORITY||||||<|0.0001|||||||ANOVA|Nested repeated measures design||Repeated measures general linear model (SS/drug treatments by visits) where arm of drug therapy as between subjects effect and visit (baseline and 32 weeks of treatment) as within subject effect||||<0.0001
72560985|NCT03480022|144652576|SUPERIORITY||||||>|0.05|||||||ANOVA|Nested repeated measures design||Repeated measures general linear model (SS/drug treatments by visits) where arm of drug therapy as between subjects effect and visit (baseline and 32 weeks of treatment) as within subject effect||||>0.05
72560986|NCT03480022|144652577|SUPERIORITY||||||>|0.05|||||||ANOVA|Nested repeated measures design||Repeated measures general linear model (SS/drug treatments by visits) where arm of drug therapy as between subjects effect and visit (baseline and 32 weeks of treatment) as within subject effect||||>0.05
72389989|NCT01980940|144287826|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6626|||||||Jonckheere-Terpstra test|||Treatment comparison of Day 14 PGART frequencies (ETOR 50 DMSO vs Placebo \[Pt 2\]) was performed using a two-sided Jonckheere-Terpstra test.||||0.6626
72446322|NCT05794243|144408709|OTHER||Ratio of Geometric Least Squares Means|0.13|||||TWO_SIDED|90.0|0.0741|0.228|||Mixed Models Analysis|||AUC (0-∞) was log-transformed and analyzed via mixed model for repeated measures with fixed effects for treatment, profile day and the treatment-by-day interaction, and a random effect for participant. The least square means (LSMs) and differences in LSMs were back transformed to produce the ratio between geometric least square means (GLSMs).||0.228|0.0741|
72446323|NCT05794243|144408709|OTHER||Ratio of Geometric Least Squares Means|0.399|||||TWO_SIDED|90.0|0.237|0.669|||Mixed Models Analysis|||AUC (0-∞) was log-transformed and analyzed via mixed model for repeated measures with fixed effects for treatment, profile day and the treatment-by-day interaction, and a random effect for participant. The LSMs and differences in LSMs were back transformed to produce the ratio between GLSMs.||0.669|0.237|
72497850|NCT01756456|144525902|SUPERIORITY|Each of the comparisons was conducted on the data for the Phase II segment of the study using a 2 × 2 chi-square test, based on the null hypothesis that there is no association between treatment (rhNGF or Vehicle Control) and response (Complete Healing at Week 4 \[Yes/No\]).|Difference in percentage|35.3|||<|0.001|TWO_SIDED|97.06|15.88|54.71|||Chi-squared|||Phase II||54.71|15.88|<0.001
72560987|NCT03480022|144652578|SUPERIORITY||||||<|0.021|||||||ANOVA|Nested repeated measures design||Repeated measures general linear model (SS/drug treatments by visits) where arm of drug therapy as between subjects effect and visit (baseline and 32 weeks of treatment) as within subject effect||||<0.021
72389990|NCT01980940|144287826|SUPERIORITY_OR_OTHER_LEGACY|||||||0.315|||||||Jonckheere-Terpstra test|||Treatment comparison of post-trial PGART frequencies (ETOR 50 DMSO vs Placebo \[Pt 2\]) was performed using a two-sided Jonckheere-Terpstra test.||||0.3150
72389991|NCT03187197|144287857|OTHER|||||||0.0001|||||||Paired t-test|||Within group comparison of Baseline convenience with that of Visit 2.||||0.0001
72560988|NCT03480022|144652579|SUPERIORITY||||||<|0.009|||||||ANOVA|Nested repeated measures design||Repeated measures general linear model (SS/drug treatments by visits) where arm of drug therapy as between subjects effect and visit (baseline and 32 weeks of treatment) as within subject effect||||<0.009
72560989|NCT03480022|144652580|SUPERIORITY||||||<|0.035|||||||ANOVA|Nested repeated measures design||Repeated measures general linear model (SS/drug treatments by visits) where arm of drug therapy as between subjects effect and visit (baseline and 32 weeks of treatment) as within subject effect||||<0.035
72389992|NCT03187197|144287857|OTHER|||||||0.0001|||||||Paired t-test|||Within group comparison of Baseline convenience with that of Visit 3.||||0.0001
72389993|NCT03187197|144287857|OTHER|||||||0.0031|||||||Paired t-test|||Within group comparison of Baseline satisfaction with that of Visit 2.||||0.0031
72389994|NCT03187197|144287857|OTHER|||||||0.0001|||||||Paired t-test|||Within group comparison of Baseline satisfaction with that of Visit 3.||||0.0001
72560990|NCT03480022|144652581|SUPERIORITY||||||<|0.028|||||||ANOVA|Nested repeated measures design||Repeated measures general linear model (SS/drug treatments by visits) where arm of drug therapy as between subjects effect and visit (baseline and 32 weeks of treatment) as within subject effect||||<0.028
72389995|NCT03187197|144287858|OTHER|||||||0.7879|||||||t-test, 2 sided|||Between group comparison of Visit 2 treatment convenience before PSM.||||0.7879
72389996|NCT03187197|144287858|OTHER|||||||0.611|||||||t-test, 2 sided|||Between group comparison of Visit 3 treatment convenience before PSM.||||0.6110
72389997|NCT03187197|144287858|OTHER|||||||0.0832|||||||t-test, 2 sided|||Between group comparison of Visit 2 treatment satisfaction before PSM.||||0.0832
72389998|NCT03187197|144287858|OTHER|||||||0.6488|||||||t-test, 2 sided|||Between group comparison of Visit 3 treatment satisfaction before PSM.||||0.6488
72389999|NCT03187197|144287858|OTHER|||||||0.1301|||||||Two sample T test|||Between group comparison of Visit 2 treatment convenience after PSM.||||0.1301
72390000|NCT03187197|144287858|OTHER|||||||0.1257|||||||Two sample T test|||Between group comparison of Visit 2 treatment satisfaction after PSM.||||0.1257
72390001|NCT02200211|144287867|NON_INFERIORITY|Our sample size was computed to have 90% power with a type I error of 5% for a non-inferiority limit of 0.05 logMAR (0.5 lines), assuming a standard deviation of change of 0.15 logMAR (1.5 lines) based on prior Pediatric Eye Disease Investigator Group (PEDIG) studies, and no more than 10% loss to follow-up.|Mean Difference (Final Values)|0.31|||||ONE_SIDED|95.0||0.53|||||A 1-sided upper 95% confidence interval was computed on the adjusted group difference (patching - binocular treatment) evaluating change in amblyopic-eye visual acuity from baseline to the 16-week visit. Positive values favor the patching group.|The primary outcome measure was change in amblyopic-eye VA from baseline to 16 weeks (14 to \<20 week window). The upper limit of a 1-sided 95% confidence interval (CI) was computed on the treatment group difference, using an analysis of covariance (ANCOVA) model, adjusted for baseline age and VA, including only participants completing the 16-week outcome in a modified intent-to-treat analysis. There was no imputation for missing data.||0.53||
72560991|NCT03480022|144652582|SUPERIORITY||||||<|0.042|||||||ANOVA|Nested repeated measures design||Repeated measures general linear model (SS/drug treatments by visits) where arm of drug therapy as between subjects effect and visit (baseline and 32 weeks of treatment) as within subject effect||||<0.042
72560992|NCT03480022|144652583|SUPERIORITY||||||<|0.033|||||||ANOVA|Nested repeated measures design||Repeated measures general linear model (SS/drug treatments by visits) where arm of drug therapy as between subjects effect and visit (baseline and 32 weeks of treatment) as within subject effect||||<0.033
72446324|NCT05794243|144408711|OTHER||Ratio of Geometric Least Squares Means|0.106|||||TWO_SIDED|90.0|0.062|0.182|||Mixed Models Analysis|||Cmax was log-transformed and analyzed via mixed model for repeated measures with fixed effects for treatment, profile day and the treatment-by-day interaction, and a random effect for participant. The LSMs and differences in LSMs were back transformed to produce the ratio between GLSMs.||0.182|0.0620|
72446325|NCT05794243|144408711|OTHER||Ratio of Geometric Least Squares Means|0.343|||||TWO_SIDED|90.0|0.206|0.569|||Mixed Models Analysis|||Cmax was log-transformed and analyzed via mixed model for repeated measures with fixed effects for treatment, profile day and the treatment-by-day interaction, and a random effect for participant. The LSMs and differences in LSMs were back transformed to produce the ratio between GLSMs.||0.569|0.206|
72446326|NCT02761057|144408730|SUPERIORITY||Hazard Ratio (HR)|0.6||||0.019|TWO_SIDED|95.0|0.37|0.97|||Regression, Cox|||A proportional hazards model was used to compare the Hazard Ratio (HR) for PFS.||0.97|0.37|0.019
72446327|NCT02761057|144408731|SUPERIORITY|||||||0.1|||||||Chi-squared|||The Chi-Square test will be used to compare RR between sunitinib and cabozantinib.||||0.10
72446328|NCT02761057|144408732|SUPERIORITY||Hazard Ratio (HR)|0.84|||||TWO_SIDED|95.0|0.47|1.51|||Log Rank|||The log-rank test will be used to compare OS.||1.51|0.47|
72446329|NCT03365882|144408811|SUPERIORITY||Hazard Ratio (HR)|0.79||||0.44|TWO_SIDED|95.0|0.43|1.45|||Log Rank|||||1.45|0.43|0.44
72446330|NCT03365882|144408813|SUPERIORITY|||||||0.17|||||||Log Rank|||||||0.17
72560993|NCT03480022|144652584|SUPERIORITY||||||>|0.05|||||||ANOVA|Nested repeated measures design||Repeated measures general linear model (SS/drug treatments by visits) where arm of drug therapy as between subjects effect and visit (baseline and 32 weeks of treatment) as within subject effect||||>0.05
72560994|NCT03480022|144652585|SUPERIORITY||||||>|0.05|||||||ANOVA|Nested repeated measures design||Repeated measures general linear model (SS/drug treatments by visits) where arm of drug therapy as between subjects effect and visit (baseline and 32 weeks of treatment) as within subject effect||||>0.05
72446331|NCT04323137|144408815|SUPERIORITY|||||||0.0035|||||||Regression, Logistic|||"This analysis compared all groups that were informed they were high risk (High risk only, High risk based on medical records, High risk based on algorithm) to control patients who were not sent a message.~Null hypothesis: informing patients they are high risk for flu and flu-related complications does not increase flu vaccination rate; Alternative hypothesis: informing patients they are high risk for flu and flu-related complications increases flu vaccination rate"||||0.0035
72446332|NCT04323137|144408815|SUPERIORITY|||||||0.613||||||The p-value reported is uncorrected, but the Holm method was used to determine whether the p-value reached statistical significance.|Regression, Logistic|||Null hypothesis: the High risk only and High risk based on medical records messages are equally effective at promoting ﬂu vaccinations; Alternative hypothesis: there is a difference in effectiveness between High risk only and High risk based on medical records. Separate regressions were run to assess pairwise differences between the high-risk arms (analyses 2, 3, and 4). The Holm method was used to test whether each comparison reached significance.||||.613
72446333|NCT04323137|144408815|SUPERIORITY|||||||0.889||||||The p-value reported is uncorrected, but the Holm method was used to determine whether the p-value reached statistical significance.|Regression, Logistic|||Null hypothesis: the High risk only and High risk based on algorithm messages are equally effective at promoting ﬂu vaccinations; Alternative hypothesis: there is a difference in effectiveness between High risk only and High risk based on algorithm messages. Separate regressions were run to assess pairwise differences between the high-risk arms (analyses 2, 3, and 4). The Holm method was used to test whether each comparison reached significance.||||0.889
72446334|NCT04323137|144408815|SUPERIORITY|||||||0.714||||||The p-value reported is uncorrected, but the Holm method was used to determine whether the p-value reached statistical significance.|Regression, Logistic|||Null hypothesis: the High risk based on medical records and High risk based on algorithm messages are equally effective at promoting ﬂu vaccinations; Alternative hypothesis: there is a difference in effectiveness between High risk based on medical records and High risk based on algorithm messages. Separate regressions were run to assess pairwise differences between the high-risk arms (analyses 2, 3, and 4). The Holm method was used to test whether each comparison reached significance.||||.714
72497851|NCT01756456|144525902|SUPERIORITY|Each of the comparisons was conducted on the data for the Phase II segment of the study using a 2 × 2 chi-square test, based on the null hypothesis that there is no association between treatment (rhNGF or Vehicle Control) and response (Complete Healing at Week 4 \[Yes/No\]).|Difference in percentage|38.4|||=|0.001|TWO_SIDED|97.06|18.96|57.83|||Chi-squared|||||57.83|18.96|=0.001
72446335|NCT04323137|144408816|SUPERIORITY|||||||0.181||||||This p-value is from the same regression as the top 10% risk vs. top 3% risk contrast (analysis 2).|Regression, Logistic|||"This analysis tested whether vaccination differed in patients with the same risk level who were sent messages with a vague verbal (high risk) vs. specific numeric (top 10%) risk framing.~This analysis was limited to those informed they were high risk (High risk only, High risk based on medical records, High risk based on algorithm)."||||.181
72497852|NCT01756456|144525903|SUPERIORITY||Difference in percentage|25.8|||=|0.016|TWO_SIDED|97.06|3.66|47.87|||Chi-squared|||||47.87|3.66|=0.016
72497853|NCT01756456|144525903|SUPERIORITY||Difference in percentage|34.7|||=|0.002|TWO_SIDED|97.06|11.91|57.41|||Chi-squared|||||57.41|11.91|=0.002
72560995|NCT03480022|144652586|SUPERIORITY||||||<|0.016|||||||ANOVA|Nested repeated measures design||Repeated measures general linear model (SS/drug treatments by visits) where arm of drug therapy as between subjects effect and visit (baseline and 32 weeks of treatment) as within subject effect||||<0.016
72560996|NCT03480022|144652587|SUPERIORITY||||||<|0.028|||||||ANOVA|Nested repeated measures design||Repeated measures general linear model (SS/drug treatments by visits) where arm of drug therapy as between subjects effect and visit (baseline and 32 weeks of treatment) as within subject effect||||<0.028
72560997|NCT03480022|144652588|SUPERIORITY||||||<|0.01|||||||ANOVA|Nested repeated measures design||Repeated measures general linear model (SS/drug treatments by visits) where arm of drug therapy as between subjects effect and visit (baseline and 32 weeks of treatment) as within subject effect||||<0.01
72560998|NCT03480022|144652589|SUPERIORITY||||||>|0.05|||||||ANOVA|Nested repeated measures design||Repeated measures general linear model (SS/drug treatments by visits) where arm of drug therapy as between subjects effect and visit (baseline and 32 weeks of treatment) as within subject effect||||>0.05
72446336|NCT04323137|144408816|SUPERIORITY|||||||0.301||||||This p-value is from the same regression as the high risk vs. top 10% risk contrast (analysis 1).|Regression, Logistic|||"This analysis tested whether vaccination differed in patients with the same numeric risk phrasing are differentially affected due to different specific risk levels (3% vs. 10%).~This analysis was limited to those informed they were high risk (High risk only, High risk based on medical records, High risk based on algorithm)."||||.301
72446337|NCT04229992|144408833|SUPERIORITY||||||<|0.05|||||||Regression, Linear|P value was calculated using general linear mode adjusted for age, sex, BMI and baseline level||"1. GG genotype and magnesium treatment vs GG genotype and placebo;~2. GA/AA genotype and magnesium treatment vs GA/AA genotype and Placebo."||||<0.05
72446338|NCT04229992|144408834|SUPERIORITY||||||<|0.05|||||||Regression, Linear|P value was calculated using general linear mode adjusted for age, sex, BMI and baseline level||"1. GG genotype and magnesium treatment vs GG genotype and placebo;~2. GA/AA genotype and magnesium treatment vs GA/AA genotype and Placebo"||||<0.05
72446339|NCT03770273|144408835|OTHER|||||||0.774|||||||Regression, Linear|||||||0.7740
72446340|NCT03770273|144408837|OTHER|||||||0.1071|||||||Regression, Linear|||||||0.1071
72446341|NCT03770273|144408838|OTHER|||||||0.4904|||||||Regression, Linear|||||||0.4904
72446342|NCT03770273|144408839|OTHER|||||||0.1399|||||||Regression, Linear|||||||0.1399
72446343|NCT02921230|144408847|SUPERIORITY|||||||0.0077|||||||Chi-squared|||||||0.0077
72446344|NCT01926496|144408866|SUPERIORITY||Risk Ratio (RR)|0.89||||0.03|TWO_SIDED|95.0|0.8|0.99|||Cochran-Mantel-Haenszel|Stratified by country, anatomical location and history of squamous cell carcinoma.|Cochran-Mantel-Haenszel relative risk (ingenol mebutate / imiquimod), stratified by country, anatomical location and history of squamous cell carcinoma.|||0.99|0.80|0.03
72446345|NCT01926496|144408867|SUPERIORITY||Risk Ratio (RR)|0.95||||0.18|TWO_SIDED|95.0|0.87|1.03|||Cochran-Mantel-Haenszel|Stratified by country, anatomical location and history of squamous cell carcinoma.|Cochran-Mantel-Haenszel relative risk (ingenol mebutate / imiquimod), stratified by country, anatomical location and history of squamous cell carcinoma.|||1.03|0.87|0.18
72497854|NCT01756456|144525904|SUPERIORITY||difference in percentage|2.4|||=|0.818|TWO_SIDED|97.06|-20.3|25.08|||Chi-squared|||At week 6 - reading center||25.08|-20.30|=0.818
72446346|NCT01926496|144408868|SUPERIORITY||Risk Ratio (RR)|0.66|||<|0.001|TWO_SIDED|95.0|0.52|0.84|||Cochran-Mantel-Haenszel|Stratified by country, anatomical location and history of squamous cell carcinoma.|Cochran-Mantel-Haenszel relative risk (ingenol mebutate / imiquimod), stratified by country, anatomical location and history of squamous cell carcinoma.|||0.84|0.52|<0.001
72446347|NCT03064217|144408870|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
72446348|NCT01084876|144408880|EQUIVALENCE|The therapeutic equivalence between CT-P6 and Herceptin is concluded if the 95% confidence interval (CI) for the risk difference (CT-P6 - Herceptin) estimate in ORR ITRC review during the Main Study Treatment Period is entirely within the predefined equivalence margin of -0.15 to 0.15.|Risk Difference (RD)|-0.0535|||||TWO_SIDED|95.0|-0.143|0.036||||||||0.036|-0.143|
72446349|NCT05546749|144408905|SUPERIORITY||Mean Difference (Final Values)|-1.28|STANDARD_ERROR_OF_MEAN|0.93||0.17|TWO_SIDED|95.0|-3.1|0.54|||Mixed Models Analysis|||A mixed effects model was performed to predict pain intensity by arm at weeks 3 and 6, controlling for baseline pain intensity score.||0.54|-3.1|0.17
72446350|NCT05546749|144408906|SUPERIORITY||Mean Difference (Final Values)|-13.6|STANDARD_ERROR_OF_MEAN|13.6||0.32|TWO_SIDED|95.0|-40.3|13.1|||Mixed Models Analysis|||A mixed effects model was used to predict opioid craving score by arm at weeks 3 and 6, controlling for baseline opioid craving score.||13.1|-40.3|0.32
72446351|NCT05546749|144408915|SUPERIORITY||Mean Difference (Final Values)|-9.7|STANDARD_ERROR_OF_MEAN|6.1||0.137|TWO_SIDED|95.0|-23.1|3.6|||Regression, Linear||RelieVRx was associated with lower stress score.|We performed a mixed effects model to predict stress score at week 6 by arm, controlling for baseline stress score.||3.6|-23.1|0.137
72446352|NCT02100813|144408929|SUPERIORITY_OR_OTHER_LEGACY||Rate ratio|0.31|||<|0.001|TWO_SIDED|95.0|0.23|0.42|||Negative binomial regression|||Negative binominal regression with log baseline count as offset variable and treatment group and analysis site as factors.||0.42|0.23|<0.001
72446353|NCT02100813|144408929|SUPERIORITY_OR_OTHER_LEGACY||Rate ratio|0.25|||<|0.001|TWO_SIDED|95.0|0.18|0.33|||Negative binomial regression|||Negative binominal regression with log baseline count as offset variable and treatment group and analysis site as factors.||0.33|0.18|<0.001
72446354|NCT02100813|144408929|SUPERIORITY_OR_OTHER_LEGACY||Rate ratio|0.79|||=|0.096|TWO_SIDED|95.0|0.59|1.04|||Negative binomial regression|||Negative binominal regression with log baseline count as offset variable and treatment group and analysis site as factors.||1.04|0.59|=0.096
72446355|NCT02100813|144408930|SUPERIORITY_OR_OTHER_LEGACY||Ratio of clearance rates|7.02|||=|0.007|TWO_SIDED|95.0|1.53|124.0|||Log binomial regression|||Log binomial regression with treatment group as factor and baseline AK count included as covariate.||124|1.53|=0.007
72446356|NCT02100813|144408930|SUPERIORITY_OR_OTHER_LEGACY||Ratio of clearance rates|8.82|||=|0.001|TWO_SIDED|95.0|1.99|154.5|||Log binomial regression|||Log binomial regression with treatment group as factor and baseline AK count included as covariate.||154.5|1.99|=0.001
72446357|NCT02100813|144408930|SUPERIORITY_OR_OTHER_LEGACY||Ratio of clearance rates|1.26|||=|0.43|TWO_SIDED|95.0|0.72|2.31|||Log binomial regression|||Log binomial regression with treatment group as factor and baseline AK count included as covariate.||2.31|0.72|=0.43
72446358|NCT02100813|144408931|SUPERIORITY_OR_OTHER_LEGACY||Ratio of clearance rates|8.73|||<|0.001|TWO_SIDED|95.0|2.93|51.66|||Log binomial regression|||||51.66|2.93|<0.001
72446359|NCT02100813|144408931|SUPERIORITY_OR_OTHER_LEGACY||Ratio of clearance rates|9.55|||<|0.001|TWO_SIDED|95.0|3.22|56.4|||Log binomial regression|||||56.4|3.22|<0.001
72446360|NCT02100813|144408931|SUPERIORITY_OR_OTHER_LEGACY||Ratio of clearance rates|1.09|||=|0.55|TWO_SIDED|95.0|0.81|1.49|||Log binomial regression|||||1.49|0.81|=0.55
72446361|NCT04359108|144408945|OTHER|||||||0.02|||||||ANOVA|||Navigate to Destination Test - Significance of Navigation Mode: test for null hypothesis of equivalent performance among all navigation system modes||||0.02
72446362|NCT04359108|144408945|OTHER|||||||0.22|||||||t-test, 2 sided|||Navigate to Destination Test - Argus Vision vs. Depth Vision: test for null hypothesis of equivalent performance||||0.22
72446363|NCT04359108|144408945|OTHER|||||||0.017|||||||t-test, 2 sided|||Navigate to Destination Test - Depth Vision vs. Depth Vision + Haptic/Audio: test for null hypothesis of equivalent performance||||0.017
72497855|NCT01756456|144525904|SUPERIORITY||difference in percentage|-6.3|||=|0.571|TWO_SIDED|97.06|-30.62|17.96|||Chi-squared|||at week 6 - central reading center||17.96|-30.62|=0.571
72497856|NCT01756456|144525904|SUPERIORITY||Difference in percentage|20.3|||=|0.064|TWO_SIDED|97.06|-3.11|43.79|||Chi-squared|||week 6 - investigator||43.79|-3.11|=0.064
72497857|NCT01756456|144525904|SUPERIORITY||Difference in percentage|23.1|||=|0.041|TWO_SIDED|97.06|-0.89|47.04|||Chi-squared|||week 6 - investigator||47.04|-0.89|=0.041
72497858|NCT01756456|144525904|SUPERIORITY||Difference in percentage|21.9|||=|0.031|TWO_SIDED|97.06|0.07|43.64|||Chi-squared|||week 8 - central reading center||43.64|0.07|=0.031
72497859|NCT01756456|144525904|SUPERIORITY||difference in percentage|26.9|||=|0.008|TWO_SIDED|97.06|5.57|48.28|||Chi-squared|||week 8 - central reading center||48.28|5.57|=0.008
72497860|NCT01756456|144525904|SUPERIORITY||Difference in percentage|26.1|||=|0.011|TWO_SIDED|97.06|4.18|48.01|||Chi-squared|||week 8 - investigator||48.01|4.18|=0.011
72497861|NCT01756456|144525904|SUPERIORITY||Difference in percentage|25.9|||=|0.014|TWO_SIDED|97.06|3.55|48.33|||Chi-squared|||week 8 - investigator||48.33|3.55|=0.014
72497862|NCT01756456|144525905|SUPERIORITY||difference in percentage|13.7|||=|0.065|TWO_SIDED|95.0|-0.19|27.57|||Chi-squared|||week 4||27.57|-0.19|=0.065
72560999|NCT03480022|144652590|SUPERIORITY||||||>|0.05|||||||ANOVA|Nested repeated measures design||Repeated measures general linear model (SS/drug treatments by visits) where arm of drug therapy as between subjects effect and visit (baseline and 32 weeks of treatment) as within subject effect||||>0.05
72497863|NCT01756456|144525905|SUPERIORITY||difference in percentage|12.4|||=|0.097|TWO_SIDED|95.0|-2.05|26.78|||Chi-squared|||week 4||26.78|-2.05|=0.097
72497864|NCT01756456|144525905|SUPERIORITY||difference in percentage|16.9|||=|0.036|TWO_SIDED|95.0|1.97|31.92|||Chi-squared|||week 6||31.92|1.97|=0.036
72497865|NCT01756456|144525905|SUPERIORITY||difference in percentage|15.6|||=|0.054|TWO_SIDED|95.0|0.04|31.12|||Chi-squared|||week 6||31.12|0.04|=0.054
72497866|NCT01756456|144525905|SUPERIORITY||difference in percentage|17.1|||=|0.043|TWO_SIDED|95.0|1.45|32.72|||Chi-squared|||week 8||32.72|1.45|=0.043
72497867|NCT01756456|144525905|SUPERIORITY||difference in percentage|11.4|||=|0.157|TWO_SIDED|95.0|-4.08|26.93|||Chi-squared|||week 8||26.93|-4.08|=0.157
72497868|NCT01756456|144525906|SUPERIORITY||least square mean difference|8.9|||=|0.022|TWO_SIDED|95.0|1.33|16.5|||ANCOVA|||||16.50|1.33|=0.022
72497869|NCT01756456|144525906|SUPERIORITY||least square mean difference|5.0|||=|0.213|TWO_SIDED|95.0|-2.9|12.88|||ANCOVA|||||12.88|-2.90|=0.213
72497870|NCT01756456|144525907|SUPERIORITY||difference in percentage|5.5|||=|0.592|TWO_SIDED|95.0|-14.53|25.48|||Chi-squared|||week 4||25.48|-14.53|=0.592
72497871|NCT01756456|144525907|SUPERIORITY|week 4|difference in percentage|-2.3|||=|0.835|TWO_SIDED|95.0|-24.01|19.4|||Chi-squared|||||19.40|-24.01|=0.835
72497872|NCT01756456|144525907|SUPERIORITY||difference in percentage|27.7|||=|0.008|TWO_SIDED|95.0|8.1|47.22|||Chi-squared|||week 6||47.22|8.10|=0.008
72497873|NCT01756456|144525907|SUPERIORITY||difference in percentage|12.4|||=|0.282|TWO_SIDED|95.0|-9.91|34.68|||Chi-squared|||week 6||34.68|-9.91|=0.282
72497874|NCT01756456|144525907|SUPERIORITY||difference in percentage|10.2|||=|0.303|TWO_SIDED|95.0|-9.15|29.45|||Chi-squared|||||29.45|-9.15|=0.303
72497875|NCT01756456|144525907|SUPERIORITY||difference in percentage|7.9|||=|0.442|TWO_SIDED|95.0|-12.13|27.92|||Chi-squared|||week 8||27.92|-12.13|=0.442
72497876|NCT01756456|144525908|SUPERIORITY||difference in percentage|-2.6|||=|0.597|TWO_SIDED|95.0|-22.87|17.71|||Chi-squared|||week 4||17.71|-22.87|=0.597
72497877|NCT01756456|144525908|SUPERIORITY||difference in percentage|-2.3|||>|0.999|TWO_SIDED|95.0|-23.26|18.71|||Chi-squared|||week 4||18.71|-23.26|>0.999
72497878|NCT01756456|144525908|SUPERIORITY||difference in percentage|-7.8|||=|0.183|TWO_SIDED|95.0|-28.7|13.76|||Chi-squared|||week 6||13.76|-28.70|=0.183
72497879|NCT01756456|144525908|SUPERIORITY||difference in percentage|-10.0|||=|0.116|TWO_SIDED|95.0|-31.41|11.88|||Chi-squared|||week 6||11.88|-31.41|=0.116
72497880|NCT01756456|144525908|SUPERIORITY||difference in percentage|-10.8|||=|0.134|TWO_SIDED|95.0|-31.3|10.35|||Chi-squared|||week 8||10.35|-31.30|=0.134
72497881|NCT01756456|144525908|SUPERIORITY||difference in percentage|-7.9|||=|0.307|TWO_SIDED|95.0|-29.51|13.52|||Chi-squared|||week 8||13.52|-29.51|=0.307
72497882|NCT01756456|144525910|SUPERIORITY||Odds Ratio (OR)|2.18|||=|0.041|TWO_SIDED|95.0|1.03|4.62|||Chi-squared|||week 4||4.62|1.03|=0.041
72497883|NCT01756456|144525910|SUPERIORITY||Odds Ratio (OR)|1.95|||=|0.081|TWO_SIDED|95.0|0.92|4.11|||Chi-squared|||week 4||4.11|0.92|=0.081
72497884|NCT01756456|144525910|SUPERIORITY||Odds Ratio (OR)|2.47|||=|0.04|TWO_SIDED|95.0|1.04|5.88|||Chi-squared|||week 8||5.88|1.04|=0.040
72497885|NCT01756456|144525910|SUPERIORITY||Odds Ratio (OR)|1.93|||=|0.132|TWO_SIDED|95.0|0.82|4.52|||Chi-squared|||week 8||4.52|0.82|=0.132
72497886|NCT01756456|144525915|SUPERIORITY||difference in percentage|15.8|||=|0.097|TWO_SIDED|95.0|-2.36|33.97|||Chi-squared|||week 4||33.97|-2.36|=0.097
72497887|NCT01756456|144525915|SUPERIORITY||difference in percentage|13.2|||=|0.175|TWO_SIDED|95.0|-5.72|32.15|||Chi-squared|||week 4||32.15|-5.72|=0.175
72497888|NCT01756456|144525915|SUPERIORITY||difference in percentage|16.9|||=|0.105|TWO_SIDED|95.0|-3.11|37.0|||Chi-squared|||week 6||37.00|-3.11|=0.105
72497889|NCT01756456|144525915|SUPERIORITY||difference in percentage|11.0|||=|0.3|TWO_SIDED|95.0|-9.64|31.57|||Chi-squared|||week 6||31.57|-9.64|=0.300
72497890|NCT01756456|144525915|SUPERIORITY||difference in percentage|27.5|||=|0.008|TWO_SIDED|95.0|8.33|46.67|||Chi-squared|||week 8||46.67|8.33|=0.008
72497891|NCT01756456|144525915|SUPERIORITY||difference in percentage|19.0|||=|0.068|TWO_SIDED|95.0|-0.91|38.83|||Chi-squared|||week 8||38.83|-0.91|=0.068
72561000|NCT03922750|144652593|OTHER||Estimated mean treatment difference|1.01||||0.7542|TWO_SIDED|95.0|-5.33|7.35|||ANCOVA|||The response and change from baseline in response during last two weeks of treatment (week 15 and 16) were analysed using an analysis of covariance (ANCOVA) model with treatment, pre-trial insulin treatment and SGLT2i use as fixed factors, and baseline response as covariate. Missing endpoint values were imputed using multiple imputation based on own treatment arm with baseline response as a covariate. Each imputed dataset was analysed separately and estimates were combined using Rubin's rules.||7.35|-5.33|0.7542
72446364|NCT04359108|144408945|OTHER|||||||0.98|||||||t-test, 2 sided|||Navigate to Destination Test - Haptic/Audio vs. Depth Vision + Haptic/Audio: test for null hypothesis of equivalent performance||||0.98
72446365|NCT04359108|144408945|OTHER|||||||0.014|||||||t-test, 2 sided|||Navigate to Destination Test - Depth Vision vs. High Field-of-View Depth Vision: test for null hypothesis of equivalent performance||||0.014
72446366|NCT04359108|144408945|OTHER||||||<|0.001|||||||ANOVA|||Obstacle Avoidance Test - Significance of Navigation Mode: test for null hypothesis of equivalent performance among all navigation system modes||||<0.001
72446367|NCT04359108|144408945|OTHER||||||<|0.01|||||||t-test, 2 sided|||Obstacle Avoidance Test - Argus Vision vs. Depth Vision: test for null hypothesis of equivalent performance||||<0.01
72446368|NCT04359108|144408945|OTHER|||||||0.156|||||||t-test, 2 sided|||Obstacle Avoidance Test - Depth Vision vs. Depth Vision + Haptic/Audio: test for null hypothesis of equivalent performance||||0.156
72446369|NCT04359108|144408945|OTHER|||||||0.541|||||||t-test, 2 sided|||Obstacle Avoidance Test - Haptic/Audio vs. Depth Vision + Haptic/Audio: test for null hypothesis of equivalent performance||||0.541
72446370|NCT04359108|144408945|OTHER||||||<|0.01|||||||t-test, 2 sided|||Obstacle Avoidance Test - Depth Vision vs. High Field-of-View Depth Vision: test for null hypothesis of equivalent performance||||<0.01
72446371|NCT04359108|144408945|OTHER|||||||||||||||||Obstacle Avoidance Test - Argus Vision: test for null hypothesis that the single Argus participant in this arm has performance that lies in-distribution with performance statistics computed for the normally sighted subjects arm of the study.|"Test Method: Z-Score comparison of the performance of the single Argus participant to the performance distribution of normally sighted subjects.~Significance threshold: \|Z\| = 2.8 for p = 0.05, 2-tailed (reject null hypothesis above threshold) Result: Z-Score = -0.10"|||
72446372|NCT04359108|144408945|OTHER|||||||||||||||||Obstacle Avoidance Test - Depth Vision: test for null hypothesis that the single Argus participant in this arm has performance that lies in-distribution with performance statistics computed for the normally sighted subjects arm of the study.|"Test Method: Z-Score comparison of the performance of the single Argus participant to the performance distribution of normally sighted subjects.~Significance threshold: \|Z\| = 2.8 for p = 0.05, 2-tailed (reject null hypothesis above threshold) Result: Z-Score = 1.00"|||
72446373|NCT04359108|144408945|OTHER|||||||||||||||||Obstacle Avoidance Test - Depth Vision + Haptic/Audio: test for null hypothesis that the single Argus participant in this arm has performance that lies in-distribution with performance statistics computed for the normally sighted subjects arm of the study.|"Test Method: Z-Score comparison of the performance of the single Argus participant to the performance distribution of normally sighted subjects.~Significance threshold: \|Z\| = 2.8 for p = 0.05, 2-tailed (reject null hypothesis above threshold) Result: Z-Score = 0.88"|||
72446374|NCT04359108|144408945|OTHER|||||||||||||||||Obstacle Avoidance Test - Haptic/Audio: test for null hypothesis that the single Argus participant in this arm has performance that lies in-distribution with performance statistics computed for the normally sighted subjects arm of the study.|"Test Method: Z-Score comparison of the performance of the single Argus participant to the performance distribution of normally sighted subjects.~Significance threshold: \|Z\| = 2.8 for p = 0.05, 2-tailed (reject null hypothesis above threshold) Result: Z-Score = -1.6"|||
72446375|NCT04359108|144408945|OTHER|||||||||||||||||Navigate to Destination Test - Argus Vision: test for null hypothesis that the single Argus participant in this arm has performance that lies in-distribution with performance statistics computed for the normally sighted subjects arm of the study.|"Test Method: Z-Score comparison of the performance of the single Argus participant to the performance distribution of normally sighted subjects.~Significance threshold: \|Z\| = 2.8 for p = 0.05, 2-tailed (reject null hypothesis above threshold) Result: Z-Score = N/A \*~\* N/A for Argus Vision test because subject did not successfully reach intended destination for any trial using this mode."|||
72446376|NCT04359108|144408945|OTHER|||||||||||||||||Navigate to Destination Test - Depth Vision: test for null hypothesis that the single Argus participant in this arm has performance that lies in-distribution with performance statistics computed for the normally sighted subjects arm of the study.|"Test Method: Z-Score comparison of the performance of the single Argus participant to the performance distribution of normally sighted subjects.~Significance threshold: \|Z\| = 2.8 for p = 0.05, 2-tailed (reject null hypothesis above threshold) Result: Z-Score = -1.10"|||
72446377|NCT04359108|144408945|OTHER|||||||||||||||||Navigate to Destination Test - Depth Vision + Haptic/Audio: test for null hypothesis that the single Argus participant in this arm has performance that lies in-distribution with performance statistics computed for the normally sighted subjects arm of the study.|"Test Method: Z-Score comparison of the performance of the single Argus participant to the performance distribution of normally sighted subjects.~Significance threshold: \|Z\| = 2.8 for p = 0.05, 2-tailed (reject null hypothesis above threshold) Result: Z-Score = 0.45"|||
72446378|NCT04359108|144408945|OTHER|||||||||||||||||Navigate to Destination Test - Haptic/Audio: test for null hypothesis that the single Argus participant in this arm has performance that lies in-distribution with performance statistics computed for the normally sighted subjects arm of the study.|"Test Method: Z-Score comparison of the performance of the single Argus participant to the performance distribution of normally sighted subjects.~Significance threshold: \|Z\| = 2.8 for p = 0.05, 2-tailed (reject null hypothesis above threshold) Result: Z-Score = 1.02"|||
72446379|NCT04359108|144408946|OTHER|||||||0.3|||||||ANOVA|||Navigate to Destination Test - Significance of Navigation Mode: test for null hypothesis of equivalent performance among all navigation system modes||||0.30
72446380|NCT04359108|144408946|OTHER||||||<|0.001|||||||ANOVA|||Obstacle Avoidance Test - Significance of Navigation Mode: test for null hypothesis of equivalent performance among all navigation system modes||||<0.001
72446381|NCT04359108|144408946|OTHER||||||<|0.01|||||||t-test, 2 sided|||Obstacle Avoidance Test - Argus Vision vs. Depth Vision: test for null hypothesis of equivalent performance||||<0.01
72446382|NCT04359108|144408946|OTHER|||||||0.01|||||||t-test, 2 sided|||Obstacle Avoidance Test - Depth Vision vs. Depth Vision + Haptic/Audio: test for null hypothesis of equivalent performance||||0.01
72497892|NCT00854828|144525916|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
72497893|NCT02587338|144525935|SUPERIORITY|||||||0.74|||||||ANOVA|||||||0.74
72497894|NCT02587338|144525936|SUPERIORITY|||||||0.062|||||||t-test, 2 sided|||||||0.062
72446383|NCT04359108|144408946|OTHER|||||||0.93|||||||t-test, 2 sided|||Obstacle Avoidance Test - Haptic/Audio vs. Depth Vision + Haptic/Audio: test for null hypothesis of equivalent performance||||0.93
72446384|NCT04359108|144408946|OTHER||||||<|0.01|||||||t-test, 2 sided|||Obstacle Avoidance Test - Depth Vision vs. High Field-of-View Depth Vision: test for null hypothesis of equivalent performance||||<0.01
72446385|NCT04359108|144408946|OTHER|||||||||||||||||Obstacle Avoidance Test - Argus Vision: test for null hypothesis that the single Argus participant in this arm has performance that lies in-distribution with performance statistics computed for the normally sighted subjects arm of the study.|"Test Method: Z-Score comparison of the performance of the single Argus participant to the performance distribution of normally sighted subjects.~Significance threshold: \|Z\| = 2.8 for p = 0.05, 2-tailed (reject null hypothesis above threshold) Result: Z-Score = -0.27"|||
72446386|NCT04359108|144408946|OTHER|||||||||||||||||Obstacle Avoidance Test - Depth Vision: test for null hypothesis that the single Argus participant in this arm has performance that lies in-distribution with performance statistics computed for the normally sighted subjects arm of the study.|"Test Method: Z-Score comparison of the performance of the single Argus participant to the performance distribution of normally sighted subjects.~Significance threshold: \|Z\| = 2.8 for p = 0.05, 2-tailed (reject null hypothesis above threshold) Result: Z-Score = 1.00"|||
72446387|NCT04359108|144408946|OTHER|||||||||||||||||Obstacle Avoidance Test - Depth Vision + Haptic/Audio: test for null hypothesis that the single Argus participant in this arm has performance that lies in-distribution with performance statistics computed for the normally sighted subjects arm of the study.|"Test Method: Z-Score comparison of the performance of the single Argus participant to the performance distribution of normally sighted subjects.~Significance threshold: \|Z\| = 2.8 for p = 0.05, 2-tailed (reject null hypothesis above threshold) Result: Z-Score = 2.75"|||
72497895|NCT01506882|144525937|SUPERIORITY_OR_OTHER||Percent|73.8|||||TWO_SIDED|95.0|60.9|84.2||||||"The primary efficacy variable was to be calculated as the proportion p=n/N of subjects (n) staying seizure free for 6 months out of the total number of subjects (N). For this proportion p, an exact 2-sided 95% confidence interval (CI) was computed based on the F distribution.~The hypothesis H0: p=0.4 was to be formally rejected in favor of H1: p\>0.4, if the lower confidence limit for p was greater than 0.4."||84.2|60.9|
72497896|NCT01302808|144525945|OTHER||Maximum Tolerated Dose|8.0|||||TWO_SIDED|||||||||||||
72497897|NCT00821678|144525947|SUPERIORITY_OR_OTHER||Slope|-3.81||||0.002|TWO_SIDED|95.0|-6.19|-1.43|||Mixed Models Analysis|||||-1.43|-6.19|0.002
72497898|NCT00821678|144525948|SUPERIORITY_OR_OTHER||Slope|-0.25||||0.001|TWO_SIDED|95.0|-0.4|-0.1|||Mixed Models Analysis|||||-0.1|-0.4|0.001
72561001|NCT03922750|144652593|OTHER||Estimated mean treatment difference|7.88||||0.0107|TWO_SIDED|95.0|1.83|13.93|||ANCOVA|||The response and change from baseline in response during last two weeks of treatment (week 15 and 16) were analysed using an analysis of covariance (ANCOVA) model with treatment, pre-trial insulin treatment and SGLT2i use as fixed factors, and baseline response as covariate. Missing endpoint values were imputed using multiple imputation based on own treatment arm with baseline response as a covariate. Each imputed dataset was analysed separately and estimates were combined using Rubin's rules.||13.93|1.83|0.0107
72446388|NCT04359108|144408946|OTHER|||||||||||||||||Obstacle Avoidance Test - Haptic/Audio: test for null hypothesis that the single Argus participant in this arm has performance that lies in-distribution with performance statistics computed for the normally sighted subjects arm of the study.|"Test Method: Z-Score comparison of the performance of the single Argus participant to the performance distribution of normally sighted subjects.~Significance threshold: \|Z\| = 2.8 for p = 0.05, 2-tailed (reject null hypothesis above threshold) Result: Z-Score = 0.60"|||
72446389|NCT04359108|144408946|OTHER|||||||||||||||||Navigate to Destination Test - Argus Vision: test for null hypothesis that the single Argus participant in this arm has performance that lies in-distribution with performance statistics computed for the normally sighted subjects arm of the study.|"Test Method: Z-Score comparison of the performance of the single Argus participant to the performance distribution of normally sighted subjects.~Significance threshold: \|Z\| = 2.8 for p = 0.05, 2-tailed (reject null hypothesis above threshold) Result: Z-Score = N/A\*~\* N/A for Argus Vision test because subject did not successfully reach intended destination for any trial using this mode."|||
72497899|NCT00821678|144525949|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.18||||0.48|TWO_SIDED|95.0|-0.33|0.7|||t-test, 2 sided|||||0.70|-0.33|0.48
72497900|NCT00821678|144525950|SUPERIORITY_OR_OTHER||Slope|2.67||||0.02|TWO_SIDED|95.0|0.45|4.91|||Mixed Models Analysis|||||4.91|0.45|0.02
72497901|NCT00821678|144525953|SUPERIORITY_OR_OTHER||Odds Ratio, log|0.86||||0.65|TWO_SIDED|95.0|0.46|1.62|||Mixed Models Analysis|||||1.62|0.46|0.65
72497902|NCT00821678|144525954|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|7.9|||<|0.001|TWO_SIDED|95.0|3.2|19.6|||Mixed Models Analysis|||||19.6|3.2|<0.001
72497903|NCT02591615|144525955|SUPERIORITY|||||||0.2176|||||||Fisher Exact|||||||0.2176
72497904|NCT02591615|144525956|SUPERIORITY||Hazard Ratio (HR)|1.04||||0.84|TWO_SIDED|95.0|0.67|1.64|||Log Rank|||||1.64|0.67|0.84
72497905|NCT04574999|144525969|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
72497906|NCT04574999|144525970|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
72497907|NCT04574999|144525972|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
72497908|NCT04574999|144525973|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
72497909|NCT00008385|144525984|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|1.25||||0.294|TWO_SIDED|95.0|0.64|2.37||This p value should be compared to the nominal p value of 0.0035 adjusting for the previous interim analyses|Log Rank||The 95% confidence interval was repeated confidence interval for the risk ratio|||2.37|0.64|0.294
72497910|NCT00008385|144525985|SUPERIORITY_OR_OTHER_LEGACY|||||||0.069|TWO_SIDED||||||Log Rank|||||||0.069
72497911|NCT00008385|144525986|SUPERIORITY_OR_OTHER_LEGACY|||||||0.154|TWO_SIDED||||||Log Rank|||||||0.154
72561002|NCT00702507|144652631|SUPERIORITY_OR_OTHER||Percentage of participants|29.2|||||TWO_SIDED|95.0|22.4|36.7|||||Percentage of participants with overall cure at the test-of-cure visit (Day 14) of the initial episode for participants in the MITT Population|||36.7|22.4|
72561003|NCT01321177|144652646|SUPERIORITY|||||||0.0145|||||||Regression, Linear|||||||0.0145
72446390|NCT04359108|144408946|OTHER|||||||||||||||||Navigate to Destination Test - Depth Vision: test for null hypothesis that the single Argus participant in this arm has performance that lies in-distribution with performance statistics computed for the normally sighted subjects arm of the study.|"Test Method: Z-Score comparison of the performance of the single Argus participant to the performance distribution of normally sighted subjects.~Significance threshold: \|Z\| = 2.8 for p = 0.05, 2-tailed (reject null hypothesis above threshold) Result: Z-Score = -0.72"|||
72446391|NCT04359108|144408946|OTHER|||||||||||||||||Navigate to Destination Test - Argus Vision: test for null hypothesis that the single Argus participant in this arm has performance that lies in-distribution with performance statistics computed for the normally sighted subjects arm of the study.|"Test Method: Z-Score comparison of the performance of the single Argus participant to the performance distribution of normally sighted subjects.~Significance threshold: \|Z\| = 2.8 for p = 0.05, 2-tailed (reject null hypothesis above threshold) Result: Z-Score = 2.47"|||
72446392|NCT04359108|144408946|OTHER|||||||||||||||||Navigate to Destination Test - Argus Vision: test for null hypothesis that the single Argus participant in this arm has performance that lies in-distribution with performance statistics computed for the normally sighted subjects arm of the study.|"Test Method: Z-Score comparison of the performance of the single Argus participant to the performance distribution of normally sighted subjects.~Significance threshold: \|Z\| = 2.8 for p = 0.05, 2-tailed (reject null hypothesis above threshold) Result: Z-Score = 3.81"|||
72446393|NCT04359108|144408947|OTHER||||||<|0.001|||||||ANOVA|navigation system mode and test block as factors||Navigate to Destination Test - Significance of Navigation Mode: test for null hypothesis of equivalent performance among all navigation system modes||||<0.001
72446394|NCT04359108|144408947|OTHER||||||<|0.01|||||||t-test, 2 sided|within-participant, 2 sided t-test||Navigate to Destination Test - Argus Vision vs. Depth Vision: test for null hypothesis of equivalent performance||||<0.01
72446395|NCT04359108|144408947|OTHER|||||||0.037||||||within-participant, 2 sided t-test|t-test, 2 sided|||Navigate to Destination Test - Depth Vision vs. Depth Vision + Haptic/Audio: test for null hypothesis of equivalent performance||||0.037
72446396|NCT04359108|144408947|OTHER|||||||0.34|||||||t-test, 2 sided|within-participant, 2 sided t-test||Navigate to Destination Test - Haptic/Audio vs. Depth Vision + Haptic/Audio: test for null hypothesis of equivalent performance||||0.34
72446397|NCT04359108|144408947|OTHER|||||||0.1|||||||t-test, 2 sided|within-participant, 2 sided t-test||Navigate to Destination Test - Depth Vision vs. High Field-of-View Depth Vision: test for null hypothesis of equivalent performance||||0.10
72446398|NCT04359108|144408947|OTHER||||||<|0.001|||||||ANOVA|||Obstacle Avoidance Test - Significance of Navigation Mode: test for null hypothesis of equivalent performance among all navigation system modes||||<0.001
72619355|NCT01507103|144769359|SUPERIORITY_OR_OTHER||LS Means estimate|-0.2||||0.921|TWO_SIDED|95.0|-0.83|0.44|||type III SS F-test||Difference between Means adjusted on covariates baseline value and MSI category.|Category: CD8+ The difference in T cell infiltration from baseline to surgery was analysed and compared across the 3 treatment arms (effect estimate for Arm B vs Arm C) based on an ANCOVA model. Difference from baseline = Surgery value-Baseline value. Adjustment was based on ANCOVA model with treatment arm as factor and baseline value and MSI category as covariates. No interaction included. Pairwise tests have been performed to compare Arm A with Arm C, Arm B with Arm C, and Arm A with Arm B.||0.44|-0.83|0.921
72446399|NCT04359108|144408947|OTHER||||||<|0.01|||||||t-test, 2 sided|||Obstacle Avoidance Test - Argus Vision vs. Depth Vision: test for null hypothesis of equivalent performance||||<0.01
72446400|NCT04359108|144408947|OTHER|||||||0.67|||||||t-test, 2 sided|||Obstacle Avoidance Test - Depth Vision vs. Depth Vision + Haptic/Audio: test for null hypothesis of equivalent performance||||0.67
72446401|NCT04359108|144408947|OTHER|||||||0.23|||||||t-test, 2 sided|||Obstacle Avoidance Test - Haptic/Audio vs. Depth Vision + Haptic/Audio: test for null hypothesis of equivalent performance||||0.23
72446402|NCT04359108|144408947|OTHER||||||<|0.01|||||||t-test, 2 sided|||Obstacle Avoidance Test - Depth Vision vs. High Field-of-View Depth Vision: test for null hypothesis of equivalent performance||||<0.01
72446403|NCT04359108|144408947|OTHER|||||||||||||||||Obstacle Avoidance Test - Argus Vision: test for null hypothesis that the single Argus participant in this arm has performance that lies in-distribution with performance statistics computed for the normally sighted subjects arm of the study.|"Test Method: Z-Score comparison of the performance of the single Argus participant to the performance distribution of normally sighted subjects.~Significance threshold: \|Z\| = 2.8 for p = 0.05, 2-tailed (reject null hypothesis above threshold) Result: Z-Score = -0.79"|||
72446404|NCT04359108|144408947|OTHER|||||||||||||||||Obstacle Avoidance Test - Depth Vision: test for null hypothesis that the single Argus participant in this arm has performance that lies in-distribution with performance statistics computed for the normally sighted subjects arm of the study.|"Test Method: Z-Score comparison of the performance of the single Argus participant to the performance distribution of normally sighted subjects.~Significance threshold: \|Z\| = 2.8 for p = 0.05, 2-tailed (reject null hypothesis above threshold) Result: Z-Score = 1.38"|||
72446405|NCT04359108|144408947|OTHER|||||||||||||||||Obstacle Avoidance Test - Depth Vision + Haptic/Audio: test for null hypothesis that the single Argus participant in this arm has performance that lies in-distribution with performance statistics computed for the normally sighted subjects arm of the study.|"Test Method: Z-Score comparison of the performance of the single Argus participant to the performance distribution of normally sighted subjects.~Significance threshold: \|Z\| = 2.8 for p = 0.05, 2-tailed (reject null hypothesis above threshold) Result: Z-Score = 2.24"|||
72446406|NCT04359108|144408947|OTHER|||||||||||||||||Obstacle Avoidance Test - Haptic/Audio: test for null hypothesis that the single Argus participant in this arm has performance that lies in-distribution with performance statistics computed for the normally sighted subjects arm of the study.|"Test Method: Z-Score comparison of the performance of the single Argus participant to the performance distribution of normally sighted subjects.~Significance threshold: \|Z\| = 2.8 for p = 0.05, 2-tailed (reject null hypothesis above threshold) Result: Z-Score = -0.85"|||
72446407|NCT04359108|144408947|OTHER|||||||||||||||||Navigate to Destination Test - Argus Vision: test for null hypothesis that the single Argus participant in this arm has performance that lies in-distribution with performance statistics computed for the normally sighted subjects arm of the study.|"Test Method: Z-Score comparison of the performance of the single Argus participant to the performance distribution of normally sighted subjects.~Significance threshold: \|Z\| = 2.8 for p = 0.05, 2-tailed (reject null hypothesis above threshold) Result: Z-Score = N/A\*~\* N/A for Argus Vision test because subject did not successfully reach intended destination for any trial using this mode."|||
72446408|NCT04359108|144408947|OTHER|||||||||||||||||Navigate to Destination Test - Depth Vision: test for null hypothesis that the single Argus participant in this arm has performance that lies in-distribution with performance statistics computed for the normally sighted subjects arm of the study.|"Test Method: Z-Score comparison of the performance of the single Argus participant to the performance distribution of normally sighted subjects.~Significance threshold: \|Z\| = 2.8 for p = 0.05, 2-tailed (reject null hypothesis above threshold) Result: Z-Score = 0.18"|||
72446409|NCT04359108|144408947|OTHER|||||||||||||||||Navigate to Destination Test - Depth Vision + Haptic/Audio: test for null hypothesis that the single Argus participant in this arm has performance that lies in-distribution with performance statistics computed for the normally sighted subjects arm of the study.|"Test Method: Z-Score comparison of the performance of the single Argus participant to the performance distribution of normally sighted subjects.~Significance threshold: \|Z\| = 2.8 for p = 0.05, 2-tailed (reject null hypothesis above threshold) Result: Z-Score = -0.97"|||
72446410|NCT04359108|144408947|OTHER|||||||||||||||||Navigate to Destination Test - Argus Vision: test for null hypothesis that the single Argus participant in this arm has performance that lies in-distribution with performance statistics computed for the normally sighted subjects arm of the study.|"Test Method: Z-Score comparison of the performance of the single Argus participant to the performance distribution of normally sighted subjects.~Significance threshold: \|Z\| = 2.8 for p = 0.05, 2-tailed (reject null hypothesis above threshold) Result: Z-Score = -1.23"|||
72446411|NCT04359108|144408948|OTHER||||||<|0.001|||||||ANOVA|Single-factor test on navigation system mode||Navigate to Destination Test - Significance of Navigation Mode: test for null hypothesis of equivalent performance among all navigation system modes||||<0.001
72446412|NCT04359108|144408948|OTHER|||||||0.17|||||||t-test, 2 sided|||Navigate to Destination Test - Argus Vision vs. Depth Vision: test for null hypothesis of equivalent performance||||0.17
72446413|NCT04359108|144408948|OTHER||||||<|0.01|||||||t-test, 2 sided|||Navigate to Destination Test - Depth Vision vs. Depth Vision + Haptic/Audio: test for null hypothesis of equivalent performance||||<0.01
72446414|NCT04359108|144408948|OTHER|||||||0.33|||||||t-test, 2 sided|||Navigate to Destination Test - Haptic/Audio vs. Depth Vision + Haptic/Audio: test for null hypothesis of equivalent performance||||0.33
72446415|NCT04359108|144408948|OTHER||||||<|0.01|||||||t-test, 2 sided|||Navigate to Destination Test - Depth Vision vs. High Field-of-View Depth Vision: test for null hypothesis of equivalent performance||||<0.01
72446416|NCT04359108|144408949|OTHER|||||||0.023|||||||ANOVA|2X2 within-participant test with factors of resolution and field-of-view||Significance of Resolution: test for null hypothesis of equivalent performance between low and high resolution vision modes||||0.023
72619356|NCT01507103|144769359|SUPERIORITY_OR_OTHER||LS Means estimate|0.17||||0.921|TWO_SIDED|95.0|-0.5|0.83|||type III SS F-test||Difference between Means adjusted on covariates baseline value and MSI category.|Category: CD8+ The difference in T cell infiltration from baseline to surgery was analysed and compared across the 3 treatment arms (effect estimate for Arm A vs Arm B) based on an ANCOVA model. Difference from baseline = Surgery value-Baseline value. Adjustment was based on ANCOVA model with treatment arm as factor and baseline value and MSI category as covariates. No interaction included. Pairwise tests have been performed to compare Arm A with Arm C, Arm B with Arm C, and Arm A with Arm B.||0.83|-0.50|0.921
72446417|NCT04359108|144408949|OTHER|||||||0.039|||||||ANOVA|2X2 within-participant test with factors of resolution and field-of-view||Significance of Resolution: test for null hypothesis of equivalent performance between low and high field-of-view vision modes||||0.039
72446418|NCT04359108|144408949|OTHER|||||||0.801|||||||ANOVA|2x2 within-participant test with factors of resolution and field-of-view||Significance of Interaction between Resolution and Field-of-View: test for null hypothesis of no interaction||||.801
72446419|NCT03652688|144408950|SUPERIORITY||F|14.463|||<|0.001|TWO_SIDED||||||ANOVA|||The unit of analyses was the individual, nested within groups.||||<0.001
72446420|NCT03652688|144408951|SUPERIORITY|||||||0.08|||||||Chi-squared, Corrected|||||||.08
72446421|NCT03652688|144408952|SUPERIORITY|||||||0.954|||||||Chi-squared, Corrected|||||||0.954
72446422|NCT03652688|144408953|SUPERIORITY||Chi-Square|4.436||||0.035|TWO_SIDED||||||Chi-squared, Corrected|||||||.035
72446423|NCT03652688|144408954|SUPERIORITY||Chi-Square|2.615||||0.106|TWO_SIDED||||||Chi-squared, Corrected|||||||.106
72446424|NCT03652688|144408955|SUPERIORITY||Chi-Square|11.636|||<|0.001|TWO_SIDED||||||Chi-squared, Corrected|||||||<0.001
72446425|NCT05746494|144408971|OTHER|Omnibus analysis||||||0.023|||||||ANOVA|||||||0.023
72446426|NCT05746494|144408972|OTHER|Omnibus analysis||||||0.042|||||||Multilevel Modeling|||||||0.042
72446427|NCT05746494|144408973|OTHER|Omnibus analysis||||||0.98|||||||t-test, 2 sided|||||||0.980
72446428|NCT05746494|144408974|OTHER|Omnibus analysis||||||0.01|||||||Multilevel Modeling|||||||0.010
72446429|NCT05746494|144408975|OTHER|Omnibus analysis||||||0.064|||||||t-test, 2 sided|||||||0.064
72446430|NCT05746494|144408976|OTHER|Omnibus analysis||||||0.306|||||||t-test, 2 sided|||||||0.306
72446431|NCT05746494|144408977|OTHER|Omnibus analysis||||||0.041|||||||t-test, 2 sided|||||||0.041
72446432|NCT05746494|144408978|OTHER|Omnibus analysis||||||0.019|||||||t-test, 2 sided|||||||0.019
72446433|NCT05409183|144408979|OTHER||LS Mean of Treatment Difference|26.473|STANDARD_ERROR_OF_MEAN|9.216||0.0032|TWO_SIDED|95.0|7.847|45.099|||ANCOVA|||||45.099|7.847|0.0032
72446434|NCT04489771|144408991|SUPERIORITY|P-value, difference in percentage and associated 95% CI were calculated using Miettinen \& Nurminen method stratified by IMDC risk categories (favorable vs. intermediate or poor).|Difference in Percentage|-0.5||||0.5312|TWO_SIDED|95.0|-14.0|12.9||One-sided p-value for testing. H0: difference in % = 0 versus H1: difference in % \> 0.|Miettinen & Nurminen||Belzutifan 200 mg minus Belzutifan 120 mg|||12.9|-14.0|0.5312
72446435|NCT04489771|144408992|OTHER||Hazard Ratio (HR)|0.94||||0.3861|TWO_SIDED|95.0|0.63|1.4||No formal hypothesis testing performed; nominal p-value provided for treatment comparison.|Log Rank|One-sided nominal p-value based on log-rank test stratified by IMDC risk group (favorable vs. intermediate or poor).|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by IMDC risk group (favorable vs. intermediate or poor).|||1.40|0.63|0.3861
72446436|NCT04489771|144408994|OTHER|One-sided nominal p-value, difference in percentage and associated 95% CIs were based on Miettinen \& Nurminen method stratified by IMDC risk group (favorable vs. intermediate or poor).|Miettinen & Nurminen method|-6.3||||0.7832|TWO_SIDED|95.0|-21.7|9.4|||Miettinen & Nurminen method|||||9.4|-21.7|0.7832
72446437|NCT04489771|144408995|OTHER||Hazard Ratio (HR)|1.11||||0.6448|TWO_SIDED|95.0|0.65|1.9||No formal hypothesis testing performed; nominal p-value provided for treatment comparison.|Log Rank|One-sided nominal p-value based on log-rank test stratified by IMDC risk group (favorable vs. intermediate or poor).|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by IMDC risk group (favorable vs. intermediate or poor).|||1.90|0.65|0.6448
72446438|NCT03241459|144409002|NON_INFERIORITY|15.0% is the absolute noninferiority margin (50% of the difference in primary patency rate between IN.PACT Admiral DCB and PTA).|Difference in percentage|-3.7||||0.0029|ONE_SIDED|97.5|-11.7|||P-value is derived from one-sided Farrington-Manning test with noninferiority margin of 15% and a one-sided significance level of 0.025.|Farrington-Manning test||For subjects missing primary effectiveness endpoint status, a logistic regression model was used for multiple imputation with pre-specified baseline variables as model predictors.|The SurVeil DCB will be declared noninferior to IN.PACT Admiral DCB with respect to efficacy endpoint if the null hypothesis of inferiority is rejected at a one-sided significance level of 0.025.|||-11.7|0.0029
72446439|NCT03241459|144409003|NON_INFERIORITY|10.0% is the absolute noninferiority margin (50% of the difference in primary safety endpoint rate between IN.PACT Admiral DCB and PTA).|Difference in percentage|2.0|||<|0.0001|ONE_SIDED|97.5|-4.1|||P-value is derived from one-sided Farrington-Manning test with noninferiority margin of 10% and a one-sided significance level of 0.025.|Farrington-Manning test||For subjects missing primary safety endpoint status, a logistic regression model was used for multiple imputation with pre-specified baseline variables as model predictors.|The SurVeil DCB will be declared noninferior to IN.PACT Admiral DCB with respect to safety endpoint if the null hypothesis of inferiority is rejected at a one-sided significance level of 0.025.|||-4.1|<.0001
72446440|NCT03241459|144409004|SUPERIORITY|||||||0.579|TWO_SIDED|95.0||||P-value is derived from two-sided Fisher's exact test.|Fisher Exact|||The incidence estimates will be reported along with a p-value from a two-sided Fisher's exact test comparing the SurVeil and the IN.PACT Admiral groups.||||0.579
72561004|NCT03980522|144652678|OTHER||Inter-subject variance|19.1908|||||TWO_SIDED|||||||||"Inter-subject variability of CRP levels for Part 1, 2, and 4 participants was a designated primary endpoint.~Estimates of inter-subject variance and standard deviation (SD) from a mixed model for repeated measures with CRP level as the outcome, repeated effect of visit and random effect of subject. Variance Components covariance structure was assumed. The data from all scheduled pre-baseline visits was used."||||
72446441|NCT03241459|144409005|SUPERIORITY|||||||1||||||Both arms demonstrated 100% success, therefore, Fisher's exact test does not provide a p-value, but we populated it with a p-value of 1.00 to indicate no difference between arms.|Fisher Exact|||The incidence estimates will be reported along with a two-sided Fisher's exact test comparing the SurVeil and the IN.PACT Admiral groups.||||1.00
72446442|NCT03241459|144409006|SUPERIORITY|||||||1||||||P-value is derived from two-sided Fisher's exact test.|Fisher Exact|||The incidence estimates will be reported along with a two-sided Fisher's exact test comparing the SurVeil and the IN.PACT Admiral groups.||||1.000
72446443|NCT03241459|144409007|SUPERIORITY|||||||0.494||||||P-value is derived from two-sided Fisher's exact test.|Fisher Exact|||||||0.494
72446444|NCT03241459|144409008|NON_INFERIORITY|The Farrington and Manning test for noninferiority of proportions at a one-sided significance level of 0.025.|Difference in percentage|-1.9||||0.0059|ONE_SIDED|97.5|-12.1|||P-value is derived from one-sided Farrington-Manning test with noninferiority margin of 15% and a one-sided significance level of 0.025.|Farrington-Manning test|||The objective is to assess whether the primary patency rate of subjects in the SurVeil DCB group is noninferior to that of the IN.PACT Admiral DCB group:|||-12.1|0.0059
72446445|NCT03241459|144409009|SUPERIORITY|Target Vessel Patency for SurVeil DCB vs. Target Vessel Patency for IN.PACT DCB at 12 months.||||||0.699||||||12-Month P-Value|Fisher Exact|||The main analysis of the secondary endpoints will be carried out using the ITT analysis set.||||0.699
72446446|NCT03241459|144409009|SUPERIORITY|Target Vessel Patency for SurVeil DCB vs. Target Vessel Patency for IN.PACT DCB at 24 months.||||||1||||||24-Month P-Value|Fisher Exact|||The main analysis of the secondary endpoints will be carried out using the ITT analysis set.||||1.0
72446447|NCT03241459|144409010|SUPERIORITY|||||||0.699|TWO_SIDED|95.0||||6-Month P-Value|Fisher Exact|||||||0.699
72446448|NCT03241459|144409010|SUPERIORITY|||||||0.447||||||12-Month P-Value|Fisher Exact|||||||0.447
72446449|NCT03241459|144409010|SUPERIORITY|||||||0.589||||||24-Month P-Value|Fisher Exact|||||||0.589
72446450|NCT03241459|144409011|SUPERIORITY|||||||1||||||P-Value at 6-Months|Fisher Exact|||||||1.0
72446451|NCT03241459|144409011|SUPERIORITY|||||||0.823||||||P-Value at 12-Months|Fisher Exact|||||||0.823
72446452|NCT03241459|144409011|SUPERIORITY|||||||0.454||||||P-Value at 24-Months|Fisher Exact|||||||0.454
72446453|NCT03241459|144409012|SUPERIORITY|||||||0.535||||||P-Value at 6-Months|Fisher Exact|||||||0.535
72446454|NCT03241459|144409012|SUPERIORITY|||||||0.86||||||P-Value at 12-Months|Fisher Exact|||||||0.860
72446455|NCT03241459|144409012|SUPERIORITY|||||||0.39||||||P-Value at 24-Months|Fisher Exact|||||||0.390
72446456|NCT03241459|144409013|SUPERIORITY|||||||1||||||Both arms demonstrated 0 amputations at 6 months. Fisher's Exact test does not provide a p-value, but we populated it with a p-value of 1.00 to indicate no difference between arms.|Fisher Exact|||||||1.00
72446457|NCT03241459|144409013|SUPERIORITY|||||||1||||||Both arms demonstrated 0 amputations at 12 months. Fisher's Exact test does not provide a p-value, but we populated it with a p-value of 1.00 to indicate no difference between arms.|Fisher Exact|||||||1.00
72446458|NCT03241459|144409013|SUPERIORITY|||||||1||||||P-Value at 24-Months|Fisher Exact|||||||1.0
72446459|NCT03241459|144409014|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.00
72446460|NCT03241459|144409014|SUPERIORITY|||||||0.472||||||P-Value at 24-Months|Fisher Exact|||||||0.472
72446461|NCT03241459|144409015|SUPERIORITY|||||||0.193||||||P-Value for change in Rutherford Classification from BL to 1-Month|Wilcoxon (Mann-Whitney)|||||||0.193
72561005|NCT03980522|144652678|OTHER||Inter-subject variance|0.0018|||||TWO_SIDED|||||||||"Inter-subject variability of CRP levels for Part 1, 2, and 4 participants was a designated primary endpoint.~Estimates of inter-subject variance and SD from a mixed model for repeated measures with CRP level as the outcome, repeated effect of visit and random effect of subject. Variance Components covariance structure was assumed. The data from all scheduled pre-baseline visits was used."||||
72446462|NCT03241459|144409015|SUPERIORITY|||||||0.14||||||P-Value for change in Rutherford Classification from BL to 6-Months|Wilcoxon (Mann-Whitney)|||||||0.140
72446463|NCT03241459|144409015|SUPERIORITY|||||||0.372||||||P-Value for change in Rutherford Classification from BL to 12-Months|Wilcoxon (Mann-Whitney)|||||||0.372
72446464|NCT03241459|144409015|SUPERIORITY|||||||0.104||||||P-Value for change in Rutherford Classification from BL to 24-Months|Wilcoxon (Mann-Whitney)|||||||0.104
72446465|NCT03241459|144409016|SUPERIORITY|||||||0.32||||||P-Value for change in PARC from BL to 1-Month|Wilcoxon (Mann-Whitney)|||||||0.320
72446466|NCT03241459|144409016|SUPERIORITY|||||||0.132||||||P-Value for change in PARC from BL to 6-Months|Wilcoxon (Mann-Whitney)|||||||0.132
72446467|NCT03241459|144409016|SUPERIORITY|||||||0.248||||||P-Value for change in PARC from BL to 12-Months|Wilcoxon (Mann-Whitney)|||||||0.248
72446468|NCT03241459|144409016|SUPERIORITY|||||||0.194||||||P-Value for change in PARC from BL to 24-Months|Wilcoxon (Mann-Whitney)|||||||0.194
72446469|NCT03241459|144409017|SUPERIORITY|||||||0.789||||||P-Value for Decrease in Resting Target Limb ABI ≥0.15: BL to 6-Months|Fisher Exact|||||||0.789
72446470|NCT03241459|144409017|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.0
72446471|NCT03241459|144409017|SUPERIORITY|||||||0.041||||||P-Value for Decrease in Resting Target Limb ABI ≥0.15: BL to 12-Months.|Fisher Exact|||||||0.041
72446472|NCT03241459|144409017|SUPERIORITY|||||||1||||||P-Value for Decrease in Resting Target Limb TBI ≥0.15: BL to 12-Months.|Fisher Exact|||||||1.0
72446473|NCT03241459|144409017|SUPERIORITY|||||||0.401||||||P-Value for Decrease in Resting Target Limb ABI ≥0.15: BL to 24-Months.|Fisher Exact|||||||0.401
72446474|NCT03241459|144409017|SUPERIORITY|||||||1||||||P-Value for Decrease in Resting Target Limb TBI ≥0.15: BL to 24-Months.|Fisher Exact|||||||1.0
72446475|NCT03241459|144409018|OTHER|||||||0.995||||||P-value for change in WIQ from BL to 1-Month: Walking Impairment Score|Wilcoxon (Mann-Whitney)|||||||0.995
72446476|NCT03241459|144409018|SUPERIORITY|||||||0.158||||||P-value for change in WIQ from BL to 1-month: Walking distance score|Wilcoxon (Mann-Whitney)|||||||0.158
72446477|NCT03241459|144409018|SUPERIORITY|||||||0.695||||||P-value for change in WIQ from BL to 1-month: Walking speed score|Wilcoxon (Mann-Whitney)|||||||0.695
72446478|NCT03241459|144409018|SUPERIORITY|||||||0.086||||||P-value for change in WIQ from BL to 1-Month: Stair Climbing Score|Wilcoxon (Mann-Whitney)|||||||0.086
72446479|NCT03241459|144409018|SUPERIORITY|||||||0.331||||||P-value for change in WIQ from BL to 12-Months: Walking Impairment Score|Wilcoxon (Mann-Whitney)|||||||0.331
72446480|NCT03241459|144409018|SUPERIORITY|||||||0.58||||||P-value for change in WIQ from BL to 12-Months: Walking Distance Score|Wilcoxon (Mann-Whitney)|||||||0.580
72446481|NCT03241459|144409018|SUPERIORITY|||||||0.563||||||P-value for change in WIQ from BL to 12-Months: Walking Speed Score|Wilcoxon (Mann-Whitney)|||||||0.563
72561006|NCT03980522|144652678|OTHER||Inter-subject variance|0.0|||||TWO_SIDED|||||||||"Inter-subject variability of CRP levels for Part 1, 2, and 4 participants was a designated primary endpoint.~Estimates of inter-subject variance and SD from a mixed model for repeated measures with CRP level as the outcome, repeated effect of visit and random effect of subject. Variance Components covariance structure was assumed. The data from all scheduled pre-baseline visits was used."||||
72446482|NCT03241459|144409018|SUPERIORITY|||||||0.27||||||P-value for change in WIQ from BL to 12-Months: Stair Climbing Score|Wilcoxon (Mann-Whitney)|||||||0.270
72446483|NCT03241459|144409018|SUPERIORITY|||||||0.869||||||P-value for change in WIQ from BL to 24-Months: Walking Impairment Score|Wilcoxon (Mann-Whitney)|||||||0.869
72446484|NCT03241459|144409018|SUPERIORITY|||||||0.837||||||P-value for change in WIQ from BL to 24-Months: Walking Distance Score|Wilcoxon (Mann-Whitney)|||||||0.837
72446485|NCT03241459|144409018|SUPERIORITY|||||||0.674||||||P-value for change in WIQ for BL to 24-Months: Walking Speed Score|Wilcoxon (Mann-Whitney)|||||||0.674
72446486|NCT03241459|144409018|SUPERIORITY|||||||0.563||||||P-value for change in WIQ for BL to 24-Months: Stair Climbing Score|Wilcoxon (Mann-Whitney)|||||||0.563
72446487|NCT03241459|144409019|SUPERIORITY|||||||0.237||||||P-value for change in 6MWT from BL to 12-Months|t-test, 2 sided|||||||0.237
72446488|NCT03241459|144409019|SUPERIORITY|||||||0.04||||||P-value for change in 6MWT from BL to 24-Months|t-test, 2 sided|||||||0.040
72446489|NCT03241459|144409020|SUPERIORITY|||||||0.772||||||P-value for change in PAQ from BL to 1-Month: Physical Function Score|Wilcoxon (Mann-Whitney)|||||||0.772
72446490|NCT03241459|144409020|SUPERIORITY|||||||0.93||||||P-value for change in PAQ from BL to 1-Month: Stability Score|Wilcoxon (Mann-Whitney)|||||||0.930
72446491|NCT03241459|144409020|SUPERIORITY|||||||0.546||||||P-value for change in PAQ from BL to 1-Month: Symptom Score|Wilcoxon (Mann-Whitney)|||||||0.546
72446492|NCT03241459|144409020|SUPERIORITY|||||||0.621||||||P-value for change in PAQ from BL to 1-Month: Treatment Satisfaction Score|Wilcoxon (Mann-Whitney)|||||||0.621
72446493|NCT03241459|144409020|SUPERIORITY|||||||0.133||||||P-value for change in PAQ from BL to 1-Month: Quality of Life Score|Wilcoxon (Mann-Whitney)|||||||0.133
72446494|NCT03241459|144409020|SUPERIORITY|||||||0.592||||||P-value for change in PAQ from BL to 1-Month: Social Limitation Score|Wilcoxon (Mann-Whitney)|||||||0.592
72446495|NCT03241459|144409020|SUPERIORITY|||||||0.601||||||P-value for change in PAQ from BL to 1-Month: Summary Score|Wilcoxon (Mann-Whitney)|||||||0.601
72446496|NCT03241459|144409020|SUPERIORITY|||||||0.185||||||P-value for change in PAQ from BL to 12-Months: Physical Function Score|Wilcoxon (Mann-Whitney)|||||||0.185
72446497|NCT03241459|144409020|SUPERIORITY|||||||0.856||||||P-value for change in PAQ from BL to 12-Months: Stability Score|Wilcoxon (Mann-Whitney)|||||||0.856
72446498|NCT03241459|144409020|SUPERIORITY|||||||0.541||||||P-value for change in PAQ from BL to 12-Months: Symptom Score|Wilcoxon (Mann-Whitney)|||||||0.541
72446499|NCT03241459|144409020|SUPERIORITY|||||||0.731||||||P-value for change in PAQ from BL to 12-Months: Treatment Satisfaction Score|Wilcoxon (Mann-Whitney)|||||||0.731
72446500|NCT03241459|144409020|SUPERIORITY|||||||0.696||||||P-value for change in PAQ from BL to 12-Months: Quality of Life Score|Wilcoxon (Mann-Whitney)|||||||0.696
72446501|NCT03241459|144409020|SUPERIORITY|||||||0.716||||||P-value for change in PAQ from BL to 12-Months: Social Limitation Score|Wilcoxon (Mann-Whitney)|||||||0.716
72446502|NCT03241459|144409020|SUPERIORITY|||||||0.797||||||P-value for change in PAQ from BL to 12-Months: Summary Score|Wilcoxon (Mann-Whitney)|||||||0.797
72446503|NCT03241459|144409020|SUPERIORITY|||||||0.29||||||P-value for change in PAQ from BL to 24-Months: Physical Function Score|Wilcoxon (Mann-Whitney)|||||||0.290
72561007|NCT03980522|144652678|OTHER||Intra-subject variance|12.6852|||||TWO_SIDED|||||||||"Intra-subject variability of CRP levels for Part 1, 2, and 4 participants was a designated primary endpoint.~Estimates of intra-subject variance and SD from a mixed model for repeated measures with CRP level as the outcome, repeated effect of visit and random effect of subject. Variance Components covariance structure was assumed. The data from all scheduled pre-baseline visits was used."||||
72561008|NCT03980522|144652678|OTHER||Intra-subject variance|0.1842|||||TWO_SIDED|||||||||"Intra-subject variability of CRP levels for Part 1, 2, and 4 participants was a designated primary endpoint.~Estimates of intra-subject variance and SD from a mixed model for repeated measures with CRP level as the outcome, repeated effect of visit and random effect of subject. Variance Components covariance structure was assumed. The data from all scheduled pre-baseline visits was used."||||
72561009|NCT03980522|144652678|OTHER||Intra-subject variance|1.0|||||TWO_SIDED|||||||||"Intra-subject variability of CRP levels for Part 1, 2, and 4 participants was a designated primary endpoint.~Estimates of intra-subject variance and SD from a mixed model for repeated measures with CRP level as the outcome, repeated effect of visit and random effect of subject. Variance Components covariance structure was assumed. The data from all scheduled pre-baseline visits was used."||||
72561010|NCT03980522|144652679|OTHER||Inter-subject variance|34.1446|||||TWO_SIDED|||||||||"Inter-subject variability of CRP levels for Part 1, 2, and 4 participants was a designated primary endpoint.~Estimates of inter-subject variance and SD from a mixed model for repeated measures with change from baseline in CRP level as the outcome, repeated effect of visit and random effect of subject. Variance Components covariance structure was assumed. The data from all scheduled post-baseline visits was used."||||
72561011|NCT03980522|144652679|OTHER||Inter-subject variance|0.1326|||||TWO_SIDED|||||||||"Inter-subject variability of CRP levels for Part 1, 2, and 4 participants was a designated primary endpoint.~Estimates of inter-subject variance and SD from a mixed model for repeated measures with change from baseline in CRP level as the outcome, repeated effect of visit and random effect of subject. Variance Components covariance structure was assumed. The data from all scheduled post-baseline visits was used."||||
72561012|NCT03980522|144652679|OTHER||Inter-subject variance|0.0|||||TWO_SIDED|||||||||"Inter-subject variability of CRP levels for Part 1, 2, and 4 participants was a designated primary endpoint.~Estimates of inter-subject variance and SD from a mixed model for repeated measures with change from baseline in CRP level as the outcome, repeated effect of visit and random effect of subject. Variance Components covariance structure was assumed. The data from all scheduled post-baseline visits was used."||||
72561013|NCT03980522|144652679|OTHER||Intra-subject variance|0.0548|||||TWO_SIDED|||||||||"Intra-subject variability of CRP levels for Part 1, 2, and 4 participants was a designated primary endpoint.~Estimates of intra-subject variance and SD from a mixed model for repeated measures with change from baseline in CRP level as the outcome, repeated effect of visit and random effect of subject. Variance Components covariance structure was assumed. The data from all scheduled post-baseline visits was used."||||
72561014|NCT03980522|144652679|OTHER||Intra-subject variance|0.0134|||||TWO_SIDED|||||||||"Intra-subject variability of CRP levels for Part 1, 2, and 4 participants was a designated primary endpoint.~Estimates of intra-subject variance and SD from a mixed model for repeated measures with change from baseline in CRP level as the outcome, repeated effect of visit and random effect of subject. Variance Components covariance structure was assumed. The data from all scheduled post-baseline visits was used."||||
72446504|NCT03241459|144409020|SUPERIORITY|||||||0.473||||||P-value for change in PAQ from BL to 24-Months: Stability Score|Wilcoxon (Mann-Whitney)|||||||0.473
72446505|NCT03241459|144409020|SUPERIORITY|||||||0.278||||||P-value for change in PAQ from BL to 24-Months: Symptom Score|Wilcoxon (Mann-Whitney)|||||||0.278
72446506|NCT03241459|144409020|SUPERIORITY|||||||0.974||||||P-value for change in PAQ from BL to 24-Months: Treatment Satisfaction Score|Wilcoxon (Mann-Whitney)|||||||0.974
72446507|NCT03241459|144409020|SUPERIORITY|||||||0.266||||||P-value for change in PAQ from BL to 24-Months: Quality of Life Score|Wilcoxon (Mann-Whitney)|||||||0.266
72446508|NCT03241459|144409020|SUPERIORITY|||||||0.656||||||P-value for change in PAQ from BL to 24-Months: Social Limitation Score|Wilcoxon (Mann-Whitney)|||||||0.656
72446509|NCT03241459|144409020|SUPERIORITY|||||||0.959||||||P-value for change in PAQ from BL to 12-Months:Summary Score|Wilcoxon (Mann-Whitney)|||||||0.959
72446510|NCT03241459|144409021|SUPERIORITY|||||||1||||||P-Value at 36-Months|Fisher Exact|||||||1.0
72446511|NCT03241459|144409021|SUPERIORITY|||||||0.903||||||P-Value at 48-Months|Fisher Exact|||||||0.903
72446512|NCT03241459|144409021|SUPERIORITY|||||||1||||||P-Value at 60-Months|Fisher Exact|||||||1.0
72446513|NCT03241459|144409022|SUPERIORITY|||||||0.913|||||||Fisher Exact|P-Value at 36-Months||||||0.913
72446514|NCT03241459|144409022|SUPERIORITY|||||||1|||||||Fisher Exact|P-Value at 48-Months||||||1.0
72446515|NCT03241459|144409022|SUPERIORITY|||||||0.839||||||P-Value at 60-Months|Fisher Exact|||||||0.839
72446516|NCT03241459|144409023|SUPERIORITY|||||||1||||||P-Value at 36-Months|Fisher Exact|||||||1.0
72446517|NCT03241459|144409023|SUPERIORITY|||||||0.5|||||||Fisher Exact|P-Value at 48-Months||||||0.5
72446518|NCT03241459|144409023|SUPERIORITY|||||||0.251|||||||Fisher Exact|P-Value at 60-Months||||||0.251
72446519|NCT03241459|144409024|SUPERIORITY|||||||0.478||||||P-Value at 36-Months|Fisher Exact|||||||0.478
72446520|NCT03241459|144409024|SUPERIORITY|||||||0.605||||||P-Value at 48-Months|Fisher Exact|||||||0.605
72446521|NCT03241459|144409024|SUPERIORITY|||||||0.345||||||P-Value at 60-Months|Fisher Exact|||||||0.345
72446522|NCT04541147|144409047|EQUIVALENCE|Test if the number of doses in Dexamethasone Plus Analgesics group differs from that in Analgesics Alone group at a significance level of 0.05.|Mean Difference (Final Values)|6.9|STANDARD_DEVIATION|10.1||0.16|TWO_SIDED|95.0|-2.9|16.7|||t-test, 2 sided|||||16.7|-2.9|0.16
72446523|NCT04541147|144409048|EQUIVALENCE|Test if the average pain score in Dexamethasone Plus Analgesics group differs from that in Analgesics Alone group at a significance level of 0.05.|Mean Difference (Final Values)|-0.4|STANDARD_DEVIATION|1.4||0.56|TWO_SIDED|95.0|-1.8|1.0|||t-test, 2 sided|||||1.0|-1.8|0.56
72446524|NCT04541147|144409049|EQUIVALENCE|Test if the Number of participants with post-operative complications in Dexamethasone Plus Analgesics group differs from that in Analgesics Alone group at a significance level of 0.05.|Risk Difference (RD)|0.07|STANDARD_ERROR_OF_MEAN|0.15||1|TWO_SIDED|95.0|-0.22|0.36|||Fisher Exact|||||0.36|-0.22|1.00
72446525|NCT04064164|144409067|EQUIVALENCE|Pearson's Chi-square test was completed between the total instances of diminutives either identified by human or the Elderspeak App.||||||0.004||||||Dear (root word)|Chi-squared|X-squared = 8.4 df=1||||||.004
72446526|NCT04064164|144409067|EQUIVALENCE|Pearson's Chi-square test was completed between the total instances of diminutives either identified by human or the Elderspeak App. Significant associations indicated the human and app were accurately identifying true positives (1:1) or true negatives (0:0).|||||<|0.001||||||Sweet (root word)|Chi-squared|X-squared = 20.20 df=1||||||<.001
72497912|NCT05148884|144525998|OTHER|||||||0.0016|||||||Mixed Models Analysis|||Linear mixed model (LMM) of change from baseline with treatment, visit and the interaction treatment\*visit as fixed categorical effects and subject within treatment as a random effect. The baseline value of the dependent variable has been included in the model as a continuous covariate. Kenward-Roger's improved approximation for degrees of freedom (2009) has been used.||||0.0016
72497913|NCT05148884|144525998|OTHER|||||||0.6886|||||||Mixed Models Analysis|||Linear mixed model (LMM) of change from baseline with treatment, visit and the interaction treatment\*visit as fixed categorical effects and subject within treatment as a random effect. The baseline value of the dependent variable has been included in the model as a continuous covariate. Kenward-Roger's improved approximation for degrees of freedom (2009) has been used.||||0.6886
72497914|NCT05148884|144525999|OTHER|||||||0.0281|||||||Mixed Models Analysis|||Linear mixed model (LMM) of change from baseline with treatment, visit and the interaction treatment\*visit as fixed categorical effects and subject within treatment as a random effect. The baseline value of the dependent variable has been included in the model as a continuous covariate. Kenward-Roger's improved approximation for degrees of freedom (2009) has been used.||||0.0281
72497915|NCT05148884|144525999|OTHER|||||||0.7953|||||||Mixed Models Analysis|||Linear mixed model (LMM) of change from baseline with treatment, visit and the interaction treatment\*visit as fixed categorical effects and subject within treatment as a random effect. The baseline value of the dependent variable has been included in the model as a continuous covariate. Kenward-Roger's improved approximation for degrees of freedom (2009) has been used.||||0.7953
72497916|NCT01993888|144526012|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Chi-squared|||||||<.0001
72497917|NCT02162862|144526076|OTHER||||||<|0.005|||||||t-test, 2 sided|||||||<0.005
72446527|NCT04064164|144409067|EQUIVALENCE|Pearson's Chi-square test was completed between the total instances of diminutives either identified by human or the Elderspeak App.||||||0.02||||||Girl (root word)|Chi-squared|X-squared = 5.08, df=1||||||.02
72497918|NCT02162862|144526076|OTHER||||||<|0.005|||||||t-test, 2 sided|||||||<0.005
72446528|NCT04064164|144409067|EQUIVALENCE|Pearson's Chi-square test was completed between the total instances of diminutives either identified by human or the Elderspeak App.||||||0.1||||||Honey (root word)|Chi-squared|X-squared = 2.7, df= 1||||||.10
72446529|NCT04064164|144409067|EQUIVALENCE|Pearson's Chi-square test was completed between the total instances of diminutives either identified by human or the Elderspeak App.||||||0.85||||||Baby (root word)|Chi-squared|X-squared = 12.2, df = 1||||||0.85
72497919|NCT02162862|144526076|OTHER|||||||0.102|||||||t-test, 2 sided|||||||.102
72497920|NCT02162862|144526077|OTHER||||||<|0.005|||||||t-test, 2 sided|||||||<0.005
72497921|NCT02162862|144526077|OTHER|||||||0.646|||||||t-test, 2 sided|||||||.646
72497922|NCT02162862|144526077|OTHER||||||<|0.005|||||||t-test, 2 sided|||||||<0.005
72504788|NCT03114969|144540510|SUPERIORITY||Odds Ratio (OR)|28.283||||0.024|TWO_SIDED|95.0|1.561|512.532||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Incruse/Anoro Ellipta as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.|||512.532|1.561|0.024
72504789|NCT03114969|144540510|SUPERIORITY||Odds Ratio (OR)|21.736||||0.038|TWO_SIDED|95.0|1.183|399.541||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Incruse/Anoro Ellipta as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.|||399.541|1.183|0.038
72504790|NCT03114969|144540510|SUPERIORITY||Odds Ratio (OR)|7.603||||0.188|TWO_SIDED|95.0|0.371|155.763||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.|||155.763|0.371|0.188
72504791|NCT03114969|144540511|SUPERIORITY||Odds Ratio (OR)|7.781||||0.147|TWO_SIDED|95.0|0.488|124.117||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.|||124.117|0.488|0.147
72504792|NCT03114969|144540511|SUPERIORITY||Odds Ratio (OR)|9.786||||0.12|TWO_SIDED|95.0|0.553|173.301||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.|||173.301|0.553|0.120
72504793|NCT03114969|144540512|SUPERIORITY||Odds Ratio (OR)|2.089||||0.395|TWO_SIDED|95.0|0.383|11.389||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta+\[Relvar Ellipta+LAMA\] as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.|||11.389|0.383|0.395
72446530|NCT04059484|144409068|SUPERIORITY||Hazard Ratio (HR)|1.051||||0.6437|TWO_SIDED|95.0|0.789|1.4||One-sided p-value based on Stratified log-rank test. Threshold for statistical significance at 0.025 level.|Stratified Log-Rank test|Stratified on presence of visceral metastasis, prior treatment with CDK4/6 inhibitors and ECOG according to IRT.|Amcenestrant versus PCEM|A hierarchical testing procedure was used to ensure a strong control of the overall Type I error. Testing was then performed sequentially in order the outcome measures was reported and continued when previous outcome measure was statistically significant at one-sided 2.5% for the primary and the first secondary outcome.||1.4|0.789|0.6437
72446531|NCT03896789|144409153|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.95|TWO_SIDED|95.0|-3.3|3.5||The primary outcome was analyzed using a multi-level mixed-effects model, which included a random effect for site (to account for potential provider clustering) and fixed effects for covariates.|Mixed Models Analysis|Included covariates were age, gender, head maximum AIS, non-head maximum AIS, nurse: patient ratio and baseline TBI guideline adherence scores.||"Null hypothesis: Assuming no difference between usual care (control) and PEGASUS (intervention).~We used 2011-2012 results from prior pilot work in Argentina (58.6% TBI guideline adherence) to determine a sample size of 432 eligible patients (216 per arm) for the planned parallel cluster RCT, which would have 80% power to detect a 18.7% higher ICU TBI guideline adherence rate with programme implementation, with a two-sided alpha of 5%, and an intraclass coefficient of 0.05."||3.5|-3.3|.95
72446532|NCT03896789|144409159|SUPERIORITY||Mean Difference (Final Values)|7.9||||0.01|TWO_SIDED|95.0|1.9|13.8||The outcome was analyzed using a multi-level mixed-effects model, which included a random effect for site (to account for potential provider clustering) and fixed effects for covariates.|Mixed Models Analysis|Included covariates were age, gender, head maximum AIS, non-head maximum AIS, nurse: patient ratio and baseline TBI guideline adherence scores.||||13.8|1.9|.01
72446533|NCT05349500|144409175|SUPERIORITY||Mean Difference (Final Values)|-11.0||||0.019|TWO_SIDED|95.0|-20.1|-1.9|||Mixed Models Analysis|||||-1.9|-20.1|0.019
72446534|NCT05349500|144409176|SUPERIORITY||Mean Difference (Final Values)|-4.9||||0.286|TWO_SIDED|95.0|-14.1|4.3|||Mixed Models Analysis|||||4.3|-14.1|0.286
72446535|NCT05349500|144409177|SUPERIORITY||Mean Difference (Final Values)|-2.0||||0.046|TWO_SIDED|95.0|-4.0|0.0|||Mixed Models Analysis|||||-0.0|-4.0|0.046
72446536|NCT05349500|144409178|SUPERIORITY||Mean Difference (Final Values)|-1.6||||0.128|TWO_SIDED|95.0|-3.8|0.5|||Mixed Models Analysis|||||0.5|-3.8|0.128
72446537|NCT05349500|144409179|SUPERIORITY||Mean Difference (Final Values)|-7.5||||0.031|TWO_SIDED|95.0|-14.3|-0.7|||Mixed Models Analysis|||||-0.7|-14.3|0.031
72446538|NCT05349500|144409180|SUPERIORITY||Mean Difference (Final Values)|-2.0||||0.564|TWO_SIDED|95.0|-8.8|4.9|||Mixed Models Analysis|||||4.9|-8.8|0.564
72446539|NCT05349500|144409181|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.349|TWO_SIDED|95.0|-0.2|0.6|||Mixed Models Analysis|||||0.6|-0.2|0.349
72446540|NCT05349500|144409182|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.303|TWO_SIDED|95.0|-0.6|0.2|||Mixed Models Analysis|||||0.2|-0.6|0.303
72446541|NCT05349500|144409183|SUPERIORITY||Mean Difference (Final Values)|0.04||||0.507|TWO_SIDED|95.0|-0.1|0.2|||Mixed Models Analysis|||||0.2|-0.1|0.507
72446542|NCT05349500|144409184|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.729|TWO_SIDED|95.0|-0.2|0.2|||Mixed Models Analysis|||||0.2|-0.2|0.729
72446543|NCT05349500|144409185|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.421|TWO_SIDED|95.0|-0.2|0.1|||Mixed Models Analysis|||||0.1|-0.2|0.421
72446544|NCT05349500|144409186|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.648|TWO_SIDED|95.0|-0.2|0.1|||Mixed Models Analysis|||||0.1|-0.2|0.648
72446545|NCT05349500|144409187|SUPERIORITY||Mean Difference (Final Values)|3.4||||0.034|TWO_SIDED|95.0|0.3|6.5|||Mixed Models Analysis|||||6.5|0.3|0.034
72446546|NCT05349500|144409188|SUPERIORITY||Mean Difference (Final Values)|2.1||||0.315|TWO_SIDED|95.0|-2.1|6.3|||Mixed Models Analysis|||||6.3|-2.1|0.315
72446547|NCT05349500|144409189|SUPERIORITY||Mean Difference (Final Values)|13.4||||0.444|TWO_SIDED|95.0|-21.5|48.2|||Mixed Models Analysis|||||48.2|-21.5|0.444
72446548|NCT05349500|144409190|SUPERIORITY||Mean Difference (Final Values)|9.3||||0.638|TWO_SIDED|95.0|-30.6|49.2|||Mixed Models Analysis|||||49.2|-30.6|0.638
72446549|NCT05349500|144409191|SUPERIORITY||Mean Difference (Final Values)|-2.2||||0.688|TWO_SIDED|95.0|-13.4|8.9|||Mixed Models Analysis|||||8.9|-13.4|0.688
72446550|NCT05349500|144409192|SUPERIORITY||Mean Difference (Final Values)|-0.4||||0.709|TWO_SIDED|95.0|-2.5|1.7|||Mixed Models Analysis|||||1.7|-2.5|0.709
72446551|NCT05349500|144409193|SUPERIORITY||Mean Difference (Final Values)|-1.5||||0.089|TWO_SIDED|95.0|-3.3|0.2|||Mixed Models Analysis|||||0.2|-3.3|0.089
72446552|NCT05349500|144409194|SUPERIORITY||Mean Difference (Final Values)|14.9||||0.066|TWO_SIDED|95.0|-1.0|30.8|||Mixed Models Analysis|||||30.8|-1.0|0.066
72446553|NCT04788511|144409264|SUPERIORITY||Estimated Treatment Difference|7.8|||<|0.0001|TWO_SIDED|95.0|4.8|10.9|||ANCOVA|||The responses at week 52 were analyzed using an analysis of covariance model with randomized treatment and stratification (BMI\<35.0 kg/m\^2, BMI\>=35.0 kg/m\^2) as factors and baseline KCCQ-CSS as covariate. The analysis was based on the in-trial period using the FAS population. Missing observations at week 52 were multiple (x1000) imputed from retrieved participants of the same randomized treatment arm.||10.9|4.8|<0.0001
72446554|NCT04788511|144409265|SUPERIORITY||Estimated Treatment Difference|-10.7|||<|0.0001|TWO_SIDED|95.0|-11.9|-9.4|||ANCOVA|||The responses were analyzed using an analysis of covariance model with randomized treatment and stratification (BMI\<35.0 kg/m\^2, BMI\>=35.0 kg/m\^2) as factors and baseline body weight (kg) as covariate. The analysis was based on the in-trial period using the FAS population. Missing observations at week 52 were multiple (x1000) imputed from retrieved participants of the same randomized treatment arm.||-9.4|-11.9|<0.0001
72469790|NCT01575873|144463470|SUPERIORITY||LS Mean Difference|2.2|||<|0.001|TWO_SIDED|95.0|1.4|3.0||2-sided p-value corresponding to the 2-sided 95% confidence interval|ANCOVA||LS Mean Difference = Denosumab - Risedronate|"Analyses of the primary and secondary endpoints were performed independently within each subpopulation using a fixed-sequence testing procedure to control the experiment-wise type 1 error rate at a two-sided 5% significance level.~The glucocorticoid-continuing subpopulation was analyzed using an ANCOVA model adjusted for treatment, baseline BMD, sex, machine type, baseline BMD-by-machine type interaction, and duration of prior glucocorticoid use (\< 12 months vs ≥ 12 months)."||3.0|1.4|< 0.001
72390002|NCT02200211|144287867|NON_INFERIORITY|Our sample size was computed to have 90% power with a type I error of 5% for a non-inferiority limit of 0.05 logMAR (0.5 lines), assuming a standard deviation of change of 0.15 logMAR (1.5 lines) based on prior PEDIG studies, and no more than 10% loss to follow-up.|Mean Difference (Final Values)|0.3|||||ONE_SIDED|95.0||0.53|||||A 1-sided upper 95% confidence interval was computed on the adjusted group difference (patching - binocular treatment) evaluating change in amblyopic-eye visual acuity from baseline to the 16-week visit. Positive values favor the patching group.|The primary analysis was repeated for the treatment group comparison of change in amblyopic-eye VA from baseline to 16 weeks, adjusting for baseline covariates of age and visual acuity. For this sensitivity analysis, the primary analysis repeated but excluded data from participants (n=35) who completed the 16-week visit outside of the pre-defined protocol window (16 +/- 1 week).||0.53||
72390003|NCT02200211|144287867|NON_INFERIORITY|Our sample size was computed to have 90% power with a type I error of 5% for a non-inferiority limit of 0.05 logMAR (0.5 lines), assuming a standard deviation of change of 0.15 logMAR (1.5 lines) based on prior PEDIG studies, and no more than 10% loss to follow-up.|Mean Difference (Final Values)|0.31|||||ONE_SIDED|95.0||0.54|||||A 1-sided 95% confidence interval was computed on the adjusted group difference (patching - binocular treatment) evaluating change in amblyopic-eye visual acuity from baseline to the 16-week visit. Positive values favor the patching group.|The primary analysis was repeated for the treatment group comparison of change in amblyopic-eye from baseline to 16 weeks, adjusting for baseline covariates of age and visual acuity. For this sensitivity analysis, multiple imputation was used to impute 16-week visual acuity scores for participants who missed the exam (n=15) or completed the 16-week exam outside of the pre-specified analysis window (n=7).||0.54||
72390004|NCT02200211|144287867|NON_INFERIORITY|Our sample size was computed to have 90% power with a type I error of 5% for a non-inferiority limit of 0.05 logMAR (0.5 lines), assuming a standard deviation of change of 0.15 logMAR (1.5 lines) based on prior PEDIG studies, and no more than 10% loss to follow-up.|Mean Difference (Final Values)|0.33|||||ONE_SIDED|95.0||0.56|||||A 1-sided upper 95% confidence interval was computed on the adjusted group difference (patching - binocular treatment) evaluating change in amblyopic-eye visual acuity from baseline to the 16-week visit. Positive values favor the patching group.|The primary analysis was repeated for the treatment group comparison of change in amblyopic-eye VA from baseline to 16 weeks, adjusting for baseline covariates for age and visual acuity. For this post hoc sensitivity analysis, all participants with 16-week exams were included in the analysis regardless of whether or not the exam was completed within the pre-specified analysis window (14 to \<20 weeks after randomization).||0.56||
72390005|NCT02200211|144287867|NON_INFERIORITY|Our sample size was computed to have 90% power with a type I error of 5% for a non-inferiority limit of 0.05 logMAR (0.5 lines), assuming a standard deviation of change of 0.15 logMAR (1.5 lines) based on prior PEDIG studies, and no more than 10% loss to follow-up.|Mean Difference (Final Values)|0.3|||||ONE_SIDED|95.0||0.53|||||A 1-sided upper 95% confidence interval was computed on the adjusted group difference (patching - binocular treatment) evaluating change in amblyopic-eye visual acuity from baseline to the 16-week visit. Positive values favor the patching group.|The primary analysis was repeated for the treatment group comparison of change in amblyopic-eye VA from baseline to 16-weeks, adjusting for baseline covariates of age and visual acuity. For this sensitivity analysis, we excluded 16-week outcomes from enrolled participants who were subsequently found to be ineligible for the study (n=7).||0.53||
72390006|NCT02200211|144287867|NON_INFERIORITY|Our sample size was computed to have 90% power with a type I error of 5% for a non-inferiority limit of 0.05 logMAR (0.5 lines), assuming a standard deviation of change of 0.15 logMAR (1.5 lines) based on prior PEDIG studies, and no more than 10% loss to follow-up.|Mean Difference (Final Values)|0.33|||||ONE_SIDED|95.0||0.55|||||A 1-sided 95% confidence interval was computed on the adjusted group difference (patching - binocular treatment) evaluating change in amblyopic-eye visual acuity from baseline to the 16-week visit. Positive values favor the patching group.|The primary analysis was repeated for the treatment group comparison of change in amblyopic-eye visual acuity from baseline to 16 week, adjusting for baseline covariates of age and visual acuity. For this sensitivity analysis, we excluded 16-week outcomes from participants who received alternative treatment for at least 1 week during study follow-up (n=4).||0.55||
72390007|NCT02200211|144287867|SUPERIORITY||Mean Difference (Final Values)|0.31|||||TWO_SIDED|95.0|0.04|0.58|||||A 2-sided 95% confidence interval was computed on the adjusted treatment group difference evaluating change in amblyopic-eye visual acuity from baseline to the 16-week visit. Positive estimate values favor the patching treatment group.|Analysis of covariance included baseline age and visual acuity as adjustment covariates. The primary outcome measure was change in amblyopic-eye VA from baseline to 16 weeks (14 to \<20 week window). For this post hoc analysis, a 2-sided 95% confidence interval (CI) was computed on the treatment group difference, using an analysis of covariance (ANCOVA) model, adjusted for baseline age and VA, including only participants completing the 16-week outcome in a modified intent-to-treat analysis.||0.58|0.04|
72390008|NCT02200211|144287869|SUPERIORITY||Mean Difference (Final Values)|-2.7||||0.082|TWO_SIDED|95.0|-5.7|0.3||a priori threshold for statistical significance: 2-sided type I error rate of 5%|ANCOVA|Adjusted for baseline amblyopic-eye visual acuity.|A 2-sided 95% confidence interval was computed on the adjusted treatment group difference (binocular treatment - patching) evaluating change in amblyopic-eye visual acuity from baseline to the 16-week visit.|A modified intent-to-treat analysis was performed using an ANCOVA model to compare the effectiveness of two treatments (2-sided hypothesis test), adjusting for baseline visual acuity. The primary outcome measure was change in amblyopic-eye VA from baseline to 16 weeks (14 to \<20 week window). A 2-sided 95% confidence interval (CI) was computed on the adjusted treatment group difference at 16 weeks. There was no imputation for missing data.||0.3|-5.7|0.082
72469791|NCT01575873|144463471|SUPERIORITY||LS Mean Difference|1.5|||<|0.001|TWO_SIDED|95.0|0.8|2.1||2-sided p-value corresponding to the 2-sided 95% confidence interval|ANCOVA||LS Mean Difference = Denosumab - Risedronate|"Analyses of the primary and secondary endpoints were performed independently within each subpopulation using a fixed-sequence testing procedure to control the experiment-wise type 1 error rate at a two-sided 5% significance level.~The glucocorticoid-initiating subpopulation was analyzed using an ANCOVA model adjusting for treatment, baseline BMD value, sex, machine type, and baseline BMD value-by-machine type interaction."||2.1|0.8|< 0.001
72497923|NCT02348099|144526158|OTHER|"A student's paired t-test will be used to determine the difference if any in CV of Glucose between injection sites. In the third phase, area under the curve will be measured to determine differences between insulin absorption levels. Statistical analysis will be performed using SPSS version 15.0.0 and SAS version 8.2 A power calculation is a statistical method used to determine the minimum sample size needed to detect a statistically significant effect of a certain size."|Odds Ratio (OR)|95.0|||<|0.01|TWO_SIDED||||||t-test, 2 sided|||"A student's paired t-test will be used to determine the difference if any in CV of glucose between injection sited.~If the null hypothesis is true, it suggests that any changes witnessed in an experiment are because of random chance and not because of changes made to variables in the experiment. A power calculation is a statistical method used to determine the minimum sample size needed to detect a statistically significant effect of a certain size."|a P-Value is \<0.01|||<0.01
72497924|NCT02411448|144526213|OTHER||Hazard Ratio (HR)|0.591|||<|0.0001|TWO_SIDED|95.0|0.461|0.76|||Log Rank|||||0.760|0.461|<0.0001
72497925|NCT02411448|144526215|OTHER||Hazard Ratio (HR)|0.832||||0.4209|TWO_SIDED|95.0|0.532|1.303|||Log Rank|||||1.303|0.532|0.4209
72561015|NCT03980522|144652679|OTHER||Intra-subject variance|1.0|||||TWO_SIDED|||||||||"Intra-subject variability of CRP levels for Part 1, 2, and 4 participants was a designated primary endpoint.~Estimates of intra-subject variance and SD from a mixed model for repeated measures with change from baseline in CRP level as the outcome, repeated effect of visit and random effect of subject. Variance Components covariance structure was assumed. The data from all scheduled post-baseline visits was used."||||
72561016|NCT03980522|144652680|OTHER||Inter-subject variance|2.8139|||||TWO_SIDED|||||||||"Inter-subject variability of NRS Scores for Part 1, 2, and 4 participants was a designated primary endpoint.~Estimates of inter-subject variance and SD from a mixed model for repeated measures with NRS level as the outcome, repeated effect of visit and random effect of subject. Variance Components covariance structure was assumed. The data from all scheduled pre-baseline visits was used."||||
72561017|NCT03980522|144652680|OTHER||Inter-subject variance|6.9999|||||TWO_SIDED|||||||||"Inter-subject variability of NRS Scores for Part 1, 2, and 4 participants was a designated primary endpoint.~Estimates of inter-subject variance and SD from a mixed model for repeated measures with NRS level as the outcome, repeated effect of visit and random effect of subject. Variance Components covariance structure was assumed. The data from all scheduled pre-baseline visits was used."||||
72561018|NCT03980522|144652680|OTHER||Inter-subject variance|0.0|||||TWO_SIDED|||||||||"Inter-subject variability of NRS Scores for Part 1, 2, and 4 participants was a designated primary endpoint.~Estimates of inter-subject variance and SD from a mixed model for repeated measures with NRS level as the outcome, repeated effect of visit and random effect of subject. Variance Components covariance structure was assumed. The data from all scheduled pre-baseline visits was used."||||
72390009|NCT02200211|144287869|SUPERIORITY||Mean Difference (Final Values)|-2.7|||||TWO_SIDED|95.0|-5.9|0.5|||||A 2-sided 95% confidence interval was computed on the adjusted treatment group difference (binocular treatment - patching) evaluating change in amblyopic-eye visual acuity from baseline to the 16-week visit.|A modified intent-to-treat analysis was performed using an ANCOVA model to compare the change in amblyopic-eye visual acuity from baseline to 16 weeks for two treatments (2-sided hypothesis test), adjusting for baseline visual acuity. For this sensitivity analyses, the primary analysis was repeated but excluded data from participants who completed the 16-week visit outside of the pre-specified 16 +/- 1 week protocol window (n=10 participants).||0.5|-5.9|
72497926|NCT02411448|144526216|OTHER|||||||0.7413|||||||Cochran-Mantel-Haenszel|||||||0.7413
72497927|NCT02411448|144526217|OTHER|||||||1|||||||Cochran-Mantel-Haenszel|||||||1.0000
72497928|NCT02411448|144526218|OTHER||Hazard Ratio (HR)|0.619||||0.0003|TWO_SIDED|95.0|0.477|0.805|||Log Rank|||||0.805|0.477|0.0003
72497929|NCT01577238|144526237|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
72390010|NCT02200211|144287869|SUPERIORITY||Mean Difference (Final Values)|-2.8|||||TWO_SIDED|95.0|-5.9|0.3|||||A 2-sided 95% confidence interval was computed on the adjusted treatment group difference (binocular treatment - patching) evaluating change in amblyopic-eye visual acuity from baseline to the 16-week visit.|A modified intent-to-treat analysis was performed using an ANCOVA model to compare the change in amblyopic-eye visual acuity from baseline to 16 weeks (14 to \<20 week window) for two treatments (2-sided hypothesis test), adjusting for baseline visual acuity. For this sensitivity analyses, the primary analysis was repeated but excluded data from participants later found to be ineligible for the study (n=2).||0.3|-5.9|
72390011|NCT02200211|144287869|SUPERIORITY||Mean Difference (Final Values)|-1.9|||||TWO_SIDED|95.0|-5.0|1.2|||||A 2-sided 95% confidence interval was computed on the adjusted treatment group difference (binocular treatment - patching) evaluating change in amblyopic-eye visual acuity from baseline to the 16-week visit.|The primary analysis was repeated for the treatment group comparison of change in amblyopic-eye from baseline to 16 weeks, adjusting for baseline visual acuity. For this sensitivity analysis, multiple imputation was used to impute 16-week visual acuity scores for participants who missed the exam (n=3) or completed the 16-week exam outside of the pre-specified analysis window (n=2).||1.2|-5.0|
72390012|NCT02200211|144287869|SUPERIORITY||Mean Difference (Final Values)|-2.5|||||TWO_SIDED|95.0|-5.5|0.5|||||A 2-sided 95% confidence interval was computed on the adjusted treatment group difference (binocular treatment - patching) evaluating change in amblyopic-eye visual acuity from baseline to the 16-week visit.|An ANCOVA model was fit to compare the change in amblyopic-eye visual acuity from baseline to 16 weeks (14 to \<20 week window) for two treatments (2-sided hypothesis test), adjusting for baseline visual acuity. For this post hoc sensitivity analyses, the primary analysis was repeated but included data from participants who completed the 16-week visit outside the analysis window (n=2, range:14 to 28 weeks post randomization).||0.5|-5.5|
72497930|NCT01256177|144526244|SUPERIORITY_OR_OTHER||Least Square Mean difference vs Placebo|-3.22|STANDARD_ERROR_OF_MEAN|1.1||0.004|TWO_SIDED|95.0|-5.39|-1.04|||Mixed Model Repeated Measures (MMRM)|Baseline MADRS total value as covariate, treatment, bipolar strata, visit, treatment-visit interaction as fixed effects and centre as random.||Change from Baseline to Week 8 in MADRS total score based on observed cases (OC)||-1.04|-5.39|0.004
72497931|NCT01256177|144526245|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.54||||0.001|TWO_SIDED|95.0|1.56|4.13|||Regression, Logistic|Odds ratio was modeled by logistic regression adjusted for centre, baseline score, and bipolar strata.|Quetiapine XR/Placebo|||4.13|1.56|0.001
72446555|NCT03637660|144409279|NON_INFERIORITY|The noninferiority margin is defined as 10%. It can be assessed by comparing the margin (10%) to the upper limit of the 2-sided 90% CI for the difference in proportions.|Difference of proportion of participants|-0.06||||0.002|TWO_SIDED|90.0|-0.15|0.03||P-value and 2-sided 90% CI are calculated based on the noninferiority analysis for the proportion difference (one-dose group is non-inferior to three-dose group) by Farrington-Manning method with a 10% margin.|Farrington-Manning||The 2-sided 90% CI are calculated based on the noninferiority analysis for the proportion difference (one-dose group is non-inferior to three-dose group) by Farrington-Manning method with a 10% margin.|To assess the primary efficacy endpoint, the number and proportion of participants with a serological response by Month 6 and the 95% confidence interval were summarized overall and by treatment. The Farrington-Manning test at the 5% one-sided level of significance was used to test the noninferiority hypothesis. The null hypothesis for the primary objective was that the difference in proportion of participants with serological responses between the three-dose and one-dose groups was at least 10%||0.03|-0.15|0.002
72446556|NCT03637660|144409287|EQUIVALENCE|The alternative hypothesis was that the two treatment groups were unequal.|||||<|0.001||||||P-value was calculated based on 2-sided Pearson Chi-Square test. Difference in proportion was reported with the Wilson 95% CI|Chi-squared|||The number and proportion of participants who were compliant to the treatment, receiving all assigned doses within the assigned visit windows. The null hypothesis was no difference between two treatment groups.||||< 0.001
72446557|NCT03637660|144409289|NON_INFERIORITY|The noninferiority margin is defined as 10%. It can be assessed by comparing the margin (10%) to the upper limit of the 2-sided 90% CI for the difference in proportions.|Difference of proportion of participants|-0.05||||0.022|TWO_SIDED|90.0|-0.17|0.07||P-value and 2-sided 90% CI are calculated based on the noninferiority analysis for the proportion difference (one-dose group is non-inferior to three-dose group) in HIV-infected participants by Farrington-Manning method with a 10% margin.|Farrington-Manning|||The number and proportion of participants with serological response by month 6 among participants with HIV infection and the 95% confidence interval (CI) were summarized overall and by treatment status. The Farrington-Manning test at the 5% one-sided level of significance was used to test the noninferiority hypothesis. The null hypothesis was that the difference in serological response rate between the three-dose and one-dose groups was at least 10%.||0.07|-0.17|0.022
72446558|NCT03637660|144409289|NON_INFERIORITY|The noninferiority margin is defined as 10%. It can be assessed by comparing the margin (10%) to the upper limit of the 2-sided 90% CI for the difference in proportions.|Difference of proportion of participants|-0.06||||0.037|TWO_SIDED|90.0|-0.22|0.09||P-value and 2-sided 90% CI are calculated based on the noninferiority analysis for the proportion difference (one-dose group is non-inferior to three-dose group) among HIV-uninfected participants by Farrington-Manning method with a 10% margin.|Farrington-Manning|||The number and proportion of participants with serological response by month 6 among participants without HIV infection and the 95% confidence interval (CI) were summarized overall and by treatment status. The Farrington-Manning test at the 5% one-sided level of significance was used to test the noninferiority hypothesis. The null hypothesis was that the difference in serological response rate between the three-dose and one-dose groups was at least 10%.||0.09|-0.22|0.037
72469792|NCT01575873|144463471|SUPERIORITY||LS Mean Difference|1.5|||<|0.001|TWO_SIDED|95.0|1.0|2.1||2-sided p-value corresponding to the 2-sided 95% confidence interval|ANCOVA||LS Mean Difference = Denosumab - Risedronate|"Analyses of the primary and secondary endpoints were performed independently within each subpopulation using a fixed-sequence testing procedure to control the experiment-wise type 1 error rate at a two-sided 5% significance level.~The glucocorticoid-continuing subpopulation was analyzed using an ANCOVA model adjusted for treatment, baseline BMD, sex, machine type, baseline BMD-by-machine type interaction, and duration of prior glucocorticoid use (\< 12 months vs ≥ 12 months)."||2.1|1.0|< 0.001
72561019|NCT03980522|144652680|OTHER||Intra-subject variance|0.9693|||||TWO_SIDED|||||||||"Intra-subject variability of NRS Scores for Part 1, 2, and 4 participants was a designated primary endpoint.~Estimates of intra-subject variance and SD from a mixed model for repeated measures with NRS level as the outcome, repeated effect of visit and random effect of subject. Variance Components covariance structure was assumed. The data from all scheduled pre-baseline visits was used."||||
72561020|NCT03980522|144652680|OTHER||Intra-subject variance|0.0|||||TWO_SIDED|||||||||"Intra-subject variability of NRS Scores for Part 1, 2, and 4 participants was a designated primary endpoint.~Estimates of intra-subject variance and SD from a mixed model for repeated measures with NRS level as the outcome, repeated effect of visit and random effect of subject. Variance Components covariance structure was assumed. The data from all scheduled pre-baseline visits was used."||||
72561021|NCT03980522|144652680|OTHER||Intra-subject variance|1.0|||||TWO_SIDED|||||||||"Intra-subject variability of NRS Scores for Part 1, 2, and 4 participants was a designated primary endpoint.~Estimates of intra-subject variance and SD from a mixed model for repeated measures with NRS level as the outcome, repeated effect of visit and random effect of subject. Variance Components covariance structure was assumed. The data from all scheduled pre-baseline visits was used."||||
72561022|NCT03980522|144652681|OTHER||Inter-subject variance|1.9968|||||TWO_SIDED|||||||||"Inter-subject variability of NRS Scores for Part 1, 2, and 4 participants was a designated primary endpoint.~Estimates of inter-subject variance and SD from a mixed model for repeated measures with change from baseline in NRS level as the outcome, repeated effect of visit and random effect of subject. Variance Components covariance structure was assumed. The data from all scheduled post-baseline visits was used."||||
72561023|NCT03980522|144652681|OTHER||Inter-subject variance|0.9047|||||TWO_SIDED|||||||||"Inter-subject variability of NRS Scores for Part 1, 2, and 4 participants was a designated primary endpoint.~Estimates of inter-subject variance and SD from a mixed model for repeated measures with change from baseline in NRS level as the outcome, repeated effect of visit and random effect of subject. Variance Components covariance structure was assumed. The data from all scheduled post-baseline visits was used."||||
72561024|NCT03980522|144652681|OTHER||Inter-subject variance|0.0|||||TWO_SIDED|||||||||"Inter-subject variability of NRS Scores for Part 1, 2, and 4 participants was a designated primary endpoint.~Estimates of inter-subject variance and SD from a mixed model for repeated measures with change from baseline in NRS level as the outcome, repeated effect of visit and random effect of subject. Variance Components covariance structure was assumed. The data from all scheduled post-baseline visits was used."||||
72446559|NCT03637660|144409290|NON_INFERIORITY|The alternative hypothesis was that the difference in response rates was less than 10%. The noninferiority margin is defined as 10%. It can be assessed by comparing the margin (10%) to the upper limit of the 2-sided 90% CI for the difference in proportions.|Difference of proportion of participants|-0.05||||0.002|TWO_SIDED|90.0|-0.14|0.04||P-value and 2-sided 90% CI are calculated based on the noninferiority analysis for the proportion difference (one-dose group is non-inferior to three-dose group) by Farrington-Manning method with a 10% margin.|Farrington-Manning||The 2-sided 90% CI are calculated based on the noninferiority analysis for the -sproportion difference (one-dose group is non-inferior to three-dose group) by Farrington-Manning method with a 10% margin.|The number and proportion of participants with a serological response by Month 12 and the 95% confidence interval (CI) were summarized overall and by treatment. The Farrington-Manning test at the 5% one-sided level of significance was used to test the noninferiority hypothesis. The null hypothesis was that the difference in serological response rate between the three-dose and one-dose groups was at least 10%.||0.04|-0.14|0.002
72469793|NCT01575873|144463472|SUPERIORITY||LS Mean Difference|4.5|||<|0.001|TWO_SIDED|95.0|3.2|5.8||2-sided p-value corresponding to the 2-sided 95% confidence interval|ANCOVA||LS Mean Difference = Denosumab - Risedronate|"Analyses of the primary and secondary endpoints were performed independently within each subpopulation using a fixed-sequence testing procedure to control the experiment-wise type 1 error rate at a two-sided 5% significance level.~The glucocorticoid-initiating subpopulation was analyzed using an ANCOVA model adjusting for treatment, baseline BMD value, sex, machine type, and baseline BMD value-by-machine type interaction."||5.8|3.2|< 0.001
72390013|NCT02200211|144287869|SUPERIORITY||Mean Difference (Final Values)|-2.6|||||TWO_SIDED|95.0|-5.7|0.4|||||A 2-sided 95% confidence interval was computed on the adjusted treatment group difference (binocular treatment - patching) evaluating change in amblyopic-eye visual acuity from baseline to the 16-week visit.|An ANCOVA model was fit to compare the change in amblyopic-eye visual acuity from baseline to 16 weeks (14 to \<20 week window) for two treatments (2-sided hypothesis test), adjusting for baseline visual acuity. For this sensitivity analyses, the primary analysis was repeated but included prior amblyopia treatment as an adjustment covariate (in addition to baseline visual acuity) in the model.||0.4|-5.7|
72390014|NCT02200211|144287873|SUPERIORITY||Risk Difference (RD)|5.0|||||TWO_SIDED|95.0|-4.0|13.0|||||Binomial regression was used to compare the group proportions (patching - binocular treatment) of participants classified as improving 2 or more logMAR lines from baseline at the 16-week visit.|Binomial regression was used for the treatment group comparison of the proportion of participants classified as improving 2 or more logMAR lines (10 or more letters if E-ETDRS) from baseline at the 16-week visit, adjusting for baseline age group (5 to \<7, 7 to \<13 years) and baseline visual acuity (treated as a continuous covariate).||13|-4|
72390015|NCT02200211|144287873|SUPERIORITY||Risk Difference (RD)|-15.0|||||TWO_SIDED|95.0|-31.0|2.0|||||Binomial regression was used to compare the group proportions (binocular treatment - patching) of participants classified as improving 2 or more logMAR lines (≥ 10 letters) from baseline at the 16-week visit.|Binomial regression was used for the treatment group comparison of the proportion of participants classified as improving 2 or more logMAR lines (10 or more letters if E-ETDRS) from baseline at the 16-week visit, adjusting for baseline visual acuity.||2|-31|
72390016|NCT02200211|144287874|SUPERIORITY||Risk Difference (RD)|2.0|||||TWO_SIDED|95.0|-1.0|5.0|||||Binomial regression was used to compare the group proportions (patching - binocular treatment) of participants classified as having amblyopia resolution at the 16-week visit.|Binomial regression was used for the treatment group comparison of the proportion of participants classified as improving 2 or more logMAR lines (10 or more letters if E-ETDRS) from baseline at the 16-week visit, adjusting for baseline age group (5 to \<7, 7 to \<13 years) and baseline visual acuity (20/40, 20/50 or worse).||5|-1|
72390017|NCT02200211|144287875|SUPERIORITY|||||||0.83||||||For testing the interaction term, the a priori threshold for statistical significance was 0.05.|ANCOVA|Previously described above in the Statistical Analysis Overview section.||A linear mixed model was used to compare the rate of amblyopic-eye visual acuity improvement between the treatment groups. The ANCOVA model included an interaction term with treatment group and time to compare the change in visual acuity over follow-up by treatment group, adjusting for the main effects of the interaction term and baseline covariates of age and visual acuity. If the interaction term was not statistically significant (p\>0.05), no further comparisons would be performed.||||0.83
72390018|NCT02200211|144287876|SUPERIORITY|||||||0.83||||||The a priori threshold for statistical significance of the interaction term (gender and treatment group) was 0.05.|ANCOVA|Previously described in the Statistical Analysis Overview.||Exploratory subgroup analyses were conducted to assess the treatment effect according to subgroups of baseline factors. An analysis of covariance was used to test the interaction between treatment group and gender, adjusting for the main effects of the interaction term and baseline covariates of age and visual acuity.||||0.83
72390019|NCT02200211|144287876|SUPERIORITY|||||||0.54||||||The a priori threshold for statistical significance of the interaction term (race/ethnicity status and treatment group) was 0.05.|ANCOVA|Four participants (1 binocular treatment group, 3 patching group) were excluded from the analysis due to unknown/not reported race/ethnicity status.||Exploratory subgroup analyses were conducted to assess the treatment effect according to subgroups of baseline factors. An analysis of covariance was used to test the interaction between treatment group and race/ethnicity status (White/non-Hispanic, Non-White or Hispanic), adjusting for the main effects of the interaction term and baseline covariates of age and visual acuity.||||0.54
72390020|NCT02200211|144287876|SUPERIORITY|||||||0.8||||||The a priori threshold for statistical significance of the interaction term (age and treatment group) was 0.05.|ANCOVA|||Exploratory subgroup analyses were conducted to assess the treatment effect according to subgroups of baseline factors. An analysis of covariance was used to test the interaction between treatment group and age at baseline (treated as a continuous factor in the model), adjusting for the main effects of the interaction term and baseline visual acuity.||||0.80
72390021|NCT02200211|144287876|SUPERIORITY|||||||0.99||||||The a priori threshold for statistical significance of the interaction term (baseline amblyopic-eye visual acuity and treatment group) was 0.05.|ANCOVA|||Exploratory subgroup analyses were conducted to assess the treatment effect according to subgroups of baseline factors. An analysis of covariance was used to test the interaction between treatment group and baseline amblyopic-eye visual acuity (treated as a continuous factor in the model), adjusting for the main effects of the interaction term and baseline age.||||0.99
72446560|NCT03637660|144409291|NON_INFERIORITY|The alternative hypothesis was that the difference in response rates was less than 10%. The noninferiority margin is defined as 10%. It can be assessed by comparing the margin (10%) to the upper limit of the 2-sided 90% CI for the difference in proportions.|Difference of proportion of participants|-0.06||||0.011|TWO_SIDED|90.0|-0.18|0.05||P-value and 2-sided 90% CI are calculated based on the noninferiority analysis for the proportion difference (one-dose group is non-inferior to three-dose group) in HIV-infected participants by Farrington-Manning method with a 10% margin.|Farrington-Manning||The 2-sided 90% CI are calculated based on the noninferiority analysis for the -sproportion difference (one-dose group is non-inferior to three-dose group) among HIV-infected participants by Farrington-Manning method with a 10% margin.|The number and proportion of participants with a serological response by month 12 among participants with HIV infection and the 95% confidence interval (CI) were summarized overall and by treatment status. The Farrington-Manning test at the 5% one-sided level of significance was used to test the noninferiority hypothesis. The null hypothesis was that the difference in serological response rate between the three-dose and one-dose groups was at least 10%.||0.05|-0.18|0.011
72446561|NCT03637660|144409291|NON_INFERIORITY|The alternative hypothesis was that the difference in response rates was less than 10%. The noninferiority margin is defined as 10%. It can be assessed by comparing the margin (10%) to the upper limit of the 2-sided 90% CI for the difference in proportions.|Difference of proportion of participants|-0.03||||0.064|TWO_SIDED|90.0|-0.18|0.11||P-value and 2-sided 90% CI are calculated based on the noninferiority analysis for the proportion difference (one-dose group is non-inferior to three-dose group) among HIV-uninfected participants by Farrington-Manning method with a 10% margin.|Farrington-Manning||The 2-sided 90% CI are calculated based on the noninferiority analysis for the -sproportion difference (one-dose group is non-inferior to three-dose group) among HIV-uninfected participants by Farrington-Manning method with a 10% margin.|The number and proportion of participants with a serological response by month 12 amont participants without HIV infection and the 95% confidence interval (CI) were summarized overall and by treatment status. The Farrington-Manning test at the 5% one-sided level of significance was used to test the noninferiority hypothesis. The null hypothesis was that the difference in serological response rate between the three-dose and one-dose groups was at least 10%.||0.11|-0.18|0.064
72446562|NCT05603143|144409306|OTHER|||||||0.3161|||||||Log Rank|||||||0.3161
72446563|NCT05603143|144409310|OTHER|||||||0.3219|||||||Log Rank|||||||0.3219
72446564|NCT05603143|144409311|OTHER||Hazard Ratio (HR)|1.496||||0.6568|TWO_SIDED|95.0|0.25|8.952|||Log Rank||Hazard ratio and two-sided 95% CI for hazard ratio were estimated using the Cox regression.|||8.952|0.250|0.6568
72446565|NCT05603143|144409312|OTHER||Hazard Ratio (HR)|2.99||||0.319|TWO_SIDED|95.0|0.311|28.74|||Log Rank||Hazard ratio and two-sided 95% CI for hazard ratio were estimated using the Cox regression.|||28.740|0.311|0.3190
72446566|NCT05603143|144409313|OTHER|||||||0.3161|||||||Log Rank|||||||0.3161
72497932|NCT01256177|144526246|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.37||||0.001|TWO_SIDED|95.0|1.46|3.86|||Regression, Logistic|Odds ratio was modeled by logistic regression adjusted for centre, baseline score, and bipolar strata.|Quetiapine XR/Placebo|||3.86|1.46|0.001
72497933|NCT01256177|144526247|SUPERIORITY_OR_OTHER||Least Square Mean difference vs Placebo|-1.47|STANDARD_ERROR_OF_MEAN|0.67||0.029|TWO_SIDED|95.0|-2.79|-0.15|||Mixed Model Repeated Measure (MMRM)|Baseline MADRS total value as covariate, treatment, bipolar strata, visit, treatment-visit interaction as fixed effects and centre as random.||Change from Baseline to Week 1 in MADRS total score based on observed cases (OC)||-0.15|-2.79|0.029
72497934|NCT01256177|144526247|SUPERIORITY_OR_OTHER||Least Square Mean difference vs Placebo|-2.43|STANDARD_ERROR_OF_MEAN|0.88||0.006|TWO_SIDED|95.0|-4.16|-0.69|||Mixed Model Repeated Measure (MMRM)|Baseline MADRS total value as covariate, treatment, bipolar strata, visit, treatment-visit interaction as fixed effects and centre as random.||Change from Baseline to Week 2 in MADRS total score based on observed cases (OC)||-0.69|-4.16|0.006
72497935|NCT01256177|144526247|SUPERIORITY_OR_OTHER||Least Square Mean difference vs Placebo|-3.12|STANDARD_ERROR_OF_MEAN|0.95||0.001|TWO_SIDED|95.0|-5.0|-1.25|||Mixed Model Repeated Measures (MMRM)|Baseline MADRS total value as covariate, treatment, bipolar strata, visit, treatment-visit interaction as fixed effects and centre as random.||Change from Baseline to Week 4 in MADRS total score based on observed cases (OC)||-1.25|-5.00|0.001
72497936|NCT01256177|144526247|SUPERIORITY_OR_OTHER||Least Square Mean difference vs Placebo|-2.08|STANDARD_ERROR_OF_MEAN|1.03||0.045|TWO_SIDED|95.0|-4.12|-0.05|||Mixed Model Repeated Measures (MMRM)|Baseline MADRS total value as covariate, treatment, bipolar strata, visit, treatment-visit interaction as fixed effects and centre as random.||Change from Baseline to Week 6 in MADRS total score based on observed cases (OC)||-0.05|-4.12|0.045
72497937|NCT01256177|144526247|SUPERIORITY_OR_OTHER||Least Square Mean difference vs Placebo|-3.22|STANDARD_ERROR_OF_MEAN|1.1||0.004|TWO_SIDED|95.0|-5.39|-1.04|||Mixed Model Repeated Measures (MMRM)|Baseline MADRS total value as covariate, treatment, bipolar strata, visit, treatment-visit interaction as fixed effects and centre as random.||Change from Baseline to Week 8 in MADRS total score based on observed cases (OC)||-1.04|-5.39|0.004
72619357|NCT01507103|144769359|SUPERIORITY_OR_OTHER||LS Means estimate|0.02||||0.89|TWO_SIDED|95.0|-0.54|0.58|||type III SS F-test||Difference between Means adjusted on covariates baseline value and MSI category.|Category:CD8+/GrB+ The difference in T cell infiltration from baseline to surgery was analysed and compared across the 3 treatment arms (effect estimate for Arm A vs Arm C) based on an ANCOVA model. Difference from baseline=Surgery value-Baseline value. Adjustment was based on ANCOVA model with treatment arm as factor and baseline value and MSI category as covariates. No interaction included. Pairwise tests have been performed to compare Arm A with Arm C, Arm B with Arm C, and Arm A with Arm B.||0.58|-0.54|0.890
72497938|NCT01256177|144526248|SUPERIORITY_OR_OTHER||Least Square Mean difference vs Placebo|-2.24|STANDARD_ERROR_OF_MEAN|0.83||0.007|TWO_SIDED|95.0|-3.88|-0.61|||Mixed Model Repeated Measures (MMRM)|Baseline HAM-D total value as covariate, treatment, bipolar strata, visit, treatment-visit interaction as fixed effects and centre as random.||Change from Baseline to Week 8 in HAM-D total score based on observed cases (OC)||-0.61|-3.88|0.007
72561025|NCT03980522|144652681|OTHER||Intra-subject variance|1.7598|||||TWO_SIDED|||||||||"Intra-subject variability of NRS Scores for Part 1, 2, and 4 participants was a designated primary endpoint.~Estimates of intra-subject variance and SD from a mixed model for repeated measures with change from baseline in NRS level as the outcome, repeated effect of visit and random effect of subject. Variance Components covariance structure was assumed. The data from all scheduled post-baseline visits was used."||||
72619358|NCT01507103|144769359|SUPERIORITY_OR_OTHER||LS Means estimate|-0.19||||0.89|TWO_SIDED|95.0|-0.7|0.31|||type III SS F-test||Difference between Means adjusted on covariates baseline value and MSI category.|Category:CD8+/GrB+ The difference in T cell infiltration from baseline to surgery was analysed and compared across the 3 treatment arms (effect estimate for Arm B vs Arm C) based on an ANCOVA model. Difference from baseline=Surgery value-Baseline value. Adjustment was based on ANCOVA model with treatment arm as factor and baseline value and MSI category as covariates. No interaction included. Pairwise tests have been performed to compare Arm A with Arm C, Arm B with Arm C, and Arm A with Arm B.||0.31|-0.70|0.890
72446567|NCT05603143|144409314|OTHER||Hazard Ratio (HR)|1.425||||0.0859|TWO_SIDED|95.0|0.961|2.112||P-value was based on stratified Log-rank test with randomization stratification factors as the strata.|Log Rank||Hazard ratio and two-sided 95% CI for hazard ratio were estimated using the Cox regression with randomization stratification factors as covariates.|||2.112|0.961|0.0859
72446568|NCT05603143|144409315|OTHER||Treatment Difference (vs Placebo)|-0.58|||<|0.0001|TWO_SIDED|95.0|-0.83|-0.33|||MMRM||Least-squares mean (SE), 95% CI and P value were from MMRM with baseline viral load and randomization strata as covariates.|||-0.33|-0.83|< 0.0001
72446569|NCT05492318|144409326|OTHER|please note that GMR corresponds to the ratio of the Geometric LSmeans of Midazolam IV Co-Administered with Givinostat (Day 6) and the Geometric LSmeans of Midazolam of IV Alone (Day 1)|ratio of the geometric least square mean|105.67|||||TWO_SIDED|90.0|91.72|121.74||||||"Midazolam: Potential Inhibitory Effect of Givinostat on the Pharmacokinetics of Midazolam IV.~Cmax"||121.74|91.72|
72446570|NCT05492318|144409326|OTHER|please note that GMR corresponds to the ratio of the Geometric LSmeans of Midazolam IV Co-Administered with Givinostat (Day 6) and the Geometric LSmeans of Midazolam of IV Alone (Day 1)|ratio of the geometric least square mean|91.56|||||TWO_SIDED|90.0|86.16|97.31||||||1-Hydroxymidazolam: Potential Inhibitory Effect of Givinostat on the Pharmacokinetics of Midazolam IV - Cmax||97.31|86.16|
72446571|NCT05492318|144409326|OTHER|please note that GMR corresponds to the ratio of the Geometric LSmeans of Midazolam IV Co-Administered with Givinostat (Day 17) and the Geometric LSmeans of Midazolam of IV Alone (Day 1)|ratio of the Geometric LSmeans|92.13|||||TWO_SIDED|90.0|75.97|111.73||||||Midazolam: Potential Inducing Effect of Givinostat on the Pharmacokinetics of Midazolam IV - Cmax||111.73|75.97|
72446572|NCT05492318|144409326|OTHER|please note that GMR corresponds to the ratio of the Geometric LSmeans of Midazolam IV Co-Administered with Givinostat (Day 17) and the Geometric LSmeans of Midazolam of IV Alone (Day 1)|ratio of the Geometric LSmeans|93.59|||||TWO_SIDED|90.0|83.72|104.63||||||1-Hydroxymidazolam: Potential Inducing Effect of Givinostat on the Pharmacokinetics of Midazolam IV - Cmax||104.63|83.72|
72446573|NCT05492318|144409326|OTHER|GMR corresponds to the ratio of the Geometric LSmeans of Oral Midazolam Co-Administered with Givinostat (Day 7) and the Geometric LSmeans of Oral Midazolam Alone (Day 2)|ratio of the Geometric LSmeans|124.02|||||TWO_SIDED|90.0|114.38|134.47||||||Midazolam: Potential Inhibitory Effect of Givinostat on the Pharmacokinetics of Oral Midazolam - Cmax||134.47|114.38|
72446574|NCT05492318|144409326|OTHER|GMR corresponds to the ratio of the Geometric LSmeans of Oral Midazolam Co-Administered with Givinostat (Day 7) and the Geometric LSmeans of Oral Midazolam Alone (Day 2)|ratio of the Geometric LSmeans|117.47|||||TWO_SIDED|90.0|104.78|131.69||||||1-Hydroxymidazolam: Potential Inhibitory Effect of Givinostat on the Pharmacokinetics of Oral Midazolam - Max||131.69|104.78|
72561026|NCT03980522|144652681|OTHER||Intra-subject variance|2.849|||||TWO_SIDED|||||||||"Intra-subject variability of NRS Scores for Part 1, 2, and 4 participants was a designated primary endpoint.~Estimates of intra-subject variance and SD from a mixed model for repeated measures with change from baseline in NRS level as the outcome, repeated effect of visit and random effect of subject. Variance Components covariance structure was assumed. The data from all scheduled post-baseline visits was used."||||
72446575|NCT05492318|144409326|OTHER|GMR corresponds to the ratio of the Geometric LSmeans of Oral Midazolam Co-Administered with Givinostat (Day 18) and the Geometric LSmeans of Oral Midazolam Alone (Day 2)|ratio of geometric LS means|139.28|||||TWO_SIDED|90.0|128.71|150.67||||||Midazolam: Potential Inducing Effect of Givinostat on the Pharmacokinetics of Oral Midazolam - Cmax||150.67|128.71|
72446576|NCT05492318|144409326|OTHER|GMR corresponds to the ratio of the Geometric LSmeans of Oral Midazolam Co-Administered with Givinostat (Day 18) and the Geometric LSmeans of Oral Midazolam Alone (Day 2)|ratio of geometric LS means|141.61|||||TWO_SIDED|90.0|122.36|163.88||||||1-Hydroxymidazolam: Potential Inducing Effect of Givinostat on the Pharmacokinetics of Oral Midazolam - Cmax||163.88|122.36|
72446577|NCT05492318|144409327|OTHER|GMR corresponds to the ratio of the Geometric LSmeans of Dabigatran Etexilate Co-Administered with Givinostat (Day 6) and the Geometric LSmeans of Dabigatran Etexilate Alone (Day 1)|ratio of the Geometric LSmeans|73.68|||||TWO_SIDED|90.0|60.77|89.33||||||Total Dabigatran: Potential Inhibitory Effect of Givinostat on the Pharmacokinetics of Dabigatran Etexilate - Cmax||89.33|60.77|
72446578|NCT05492318|144409327|OTHER|GMR corresponds to the ratio of the Geometric LSmeans of Dabigatran Etexilate Co-Administered with Givinostat (Day 6) and the Geometric LSmeans of Dabigatran Etexilate Alone (Day 1)|ratio of the Geometric LSmeans|70.38|||||TWO_SIDED|90.0|57.94|85.5||||||Free Dabigatran: Potential Inhibitory Effect of Givinostat on the Pharmacokinetics of Dabigatran Etexilate - Cmax||85.50|57.94|
72446579|NCT05492318|144409327|OTHER|GMR corresponds to the ratio of the Geometric LSmeans of Dabigatran Etexilate Co-Administered with Givinostat (Day 17) and the Geometric LSmeans of Dabigatran Etexilate Alone (Day 1)|ratio of the Geometric LSmeans|65.31|||||TWO_SIDED|90.0|53.33|79.98||||||Total Dabigatran: Potential Inducing Effect of Givinostat on the Pharmacokinetics of Dabigatran Etexilate - Cmax||79.98|53.33|
72446580|NCT05492318|144409327|OTHER|GMR corresponds to the ratio of the Geometric LSmeans of Dabigatran Etexilate Co-Administered with Givinostat (Day 17) and the Geometric Lsmeans of Dabigatran Etexilate Alone (Day 1)|ratio of the Geometric LSmeans|62.18|||||TWO_SIDED|90.0|50.86|75.95||||||Free Dabigatran: Potential Induction Effect of Givinostat on the Pharmacokinetics of Dabigatran Etexilate. Cmax||75.95|50.86|
72561027|NCT03980522|144652681|OTHER||Intra-subject variance|1.0|||||TWO_SIDED|||||||||"Intra-subject variability of NRS Scores for Part 1, 2, and 4 participants was a designated primary endpoint.~Estimates of intra-subject variance and SD from a mixed model for repeated measures with change from baseline in NRS level as the outcome, repeated effect of visit and random effect of subject. Variance Components covariance structure was assumed. The data from all scheduled post-baseline visits was used."||||
72561028|NCT04892147|144652684|OTHER|"Mean value of Enjoyment (8-item summed scale) tested against the value of a Neutral Likert response (Neutral value = 3)."|||||<|0.001||||||The threshold for statistical significance was p = 0.05. The reported value is a calculated -p-value.|t-test, 2 sided|||||||<0.001
72561029|NCT04892147|144652685|EQUIVALENCE|Analyses were conducted using general linear models, controlling for baseline levels only with treatment group as the predictor of interest.||||||0.259||||||The threshold for statistical significance was p = 0.05|Regression, Linear|||||||0.259
72561030|NCT04892147|144652686|EQUIVALENCE|Analyses were conducted using general linear models, controlling for baseline levels only with treatment group as the predictor of interest.||||||0.711||||||The threshold for statistical significance was p = 0.05.|Regression, Linear|||||||0.711
72561031|NCT04892147|144652687|EQUIVALENCE|Analyses were conducted using general linear models, controlling for baseline levels only with treatment group as the predictor of interest.||||||0.214||||||The threshold for statistical significance was p = 0.05.|Regression, Linear|||||||0.214
72561032|NCT04892147|144652688|EQUIVALENCE|Analyses were conducted using general linear models, controlling for baseline levels only with treatment group as the predictor of interest.||||||0.317||||||The threshold for statistical significance was p = 0.05.|Regression, Linear|||||||0.317
72561033|NCT04892147|144652689|EQUIVALENCE|Analyses were conducted using general linear models, controlling for baseline levels only with treatment group as the predictor of interest.||||||0.056||||||The threshold for statistical significance was p = 0.05.|Regression, Linear|||||||0.056
72561034|NCT04892147|144652690|EQUIVALENCE|Analyses were conducted using general linear models, controlling for baseline levels only with treatment group as the predictor of interest.||||||0.562||||||The threshold for statistical significance was p = 0.05.|Regression, Linear|||||||0.562
72561035|NCT02707276|144652701|SUPERIORITY||Mean Difference (Final Values)|-0.625|STANDARD_DEVIATION|12.0|<|0.76|TWO_SIDED||||||ANCOVA|repeated measures ANCOVA|mean raw change active-sham; pooled standard deviation|Repeated measures ANCOVA with baseline MADRS scores as covariate for treatment and order effects of difference in MADRS scores.||||<0.76
72619359|NCT01507103|144769359|SUPERIORITY_OR_OTHER||LS Means estimate|0.21||||0.89|TWO_SIDED|95.0|-0.32|0.74|||type III SS F-test||Difference between Means adjusted on covariates baseline value and MSI category.|Category:CD8+/GrB+ The difference in T cell infiltration from baseline to surgery was analysed and compared across the 3 treatment arms (effect estimate for Arm A vs Arm B) based on an ANCOVA model. Difference from baseline=Surgery value-Baseline value. Adjustment was based on ANCOVA model with treatment arm as factor and baseline value and MSI category as covariates. No interaction included. Pairwise tests have been performed to compare Arm A with Arm C, Arm B with Arm C, and Arm A with Arm B.||0.74|-0.32|0.890
72619360|NCT04535362|144769401|SUPERIORITY||Mean Difference (Net)|0.05|STANDARD_ERROR_OF_MEAN|0.63||0.93|TWO_SIDED||||||Mixed Models Analysis|||The fixed effects in the mixed models were infusion rate (2.5 minutes, 5 minutes and 10 minutes (placebo)), cigarette condition (menthol vs. non-menthol), and their interaction. We also controlled for order effects of cigarette condition by including session in the models Subject was a clustering factor and different variance-covariance structures were considered within each condition and subject. The best-fitting structure was selected based on Schwartz's Bayesian Criterion.||||0.93
72446581|NCT05492318|144409332|OTHER|GMR corresponds to the ratio of the Geometric LSmeans of Midazolam IV Co-Administered with Givinostat (Day 6) and the Geometric LSmeans of Midazolam of IV Alone (Day 1)|ratio of the geometric LS means|107.35|||||TWO_SIDED|90.0|103.35|111.49||||||Midazolam: Potential Inhibitory Effect of Givinostat on the Pharmacokinetics of Midazolam IV - AUC0-t||111.49|103.35|
72446582|NCT05492318|144409332|OTHER|GMR corresponds to the ratio of the Geometric LSmeans of Midazolam IV Co-Administered with Givinostat (Day 6) and the Geometric LSmeans of Midazolam of IV Alone (Day 1)|ratio of the Geometric LSmeans|106.18|||||TWO_SIDED|90.0|100.84|111.8||||||1-Hydroxymidazolam: Potential Inhibitory Effect of Givinostat on the Pharmacokinetics of Midazolam IV - AUC0-t||111.80|100.84|
72561036|NCT02707276|144652701|SUPERIORITY||Mean Difference (Final Values)|-5.17|STANDARD_DEVIATION|4.96|<|0.33|TWO_SIDED||||||ANCOVA|Baseline covariate|Pooled deviation|ANCOVA: Analysis of group differences in change scores with baseline as a covariate||||<0.33
72446583|NCT05492318|144409332|OTHER|GMR corresponds to the ratio of the Geometric LSmeans of Midazolam IV Co-Administered with Givinostat (Day 17) and the Geometric LSmeans of Midazolam of IV Alone (Day 1)|ratio of the Geometric LSmeans|121.77|||||TWO_SIDED|90.0|117.56|126.12||||||Midazolam: Potential Inducing Effect of Givinostat on the Pharmacokinetics of Midazolam IV - AUC0-t||126.12|117.56|
72446584|NCT05492318|144409332|OTHER|GMR corresponds to the ratio of the Geometric LSmeans of Midazolam IV Co-Administered with Givinostat (Day 17) and the Geometric LSmeans of Midazolam of IV Alone (Day 1)|ratio of the Geometric LSmeans|122.97|||||TWO_SIDED|90.0|115.08|131.41||||||1-Hydroxymidazolam: Potential Inducing Effect of Givinostat on the Pharmacokinetics of Midazolam IV - AUC0-t||131.41|115.08|
72561037|NCT02707276|144652702|SUPERIORITY||Mean Difference (Net)|2.0|STANDARD_DEVIATION|9.1|<|0.61|TWO_SIDED||||||ANCOVA|repeated measures ANCOVA|raw change active-sham mean; pooled standard deviation|Repeated measures ANCOVA with baseline HARS scores as covariate for treatment and order effects of difference in HARS scores.||||<0.61
72561038|NCT02707276|144652702|SUPERIORITY||Mean Difference (Final Values)|-4.33|STANDARD_DEVIATION|4.0|<|0.32|TWO_SIDED||||||ANCOVA|baseline as covariate|pooled deviation|ANCOVA: Analysis of group differences in change scores with baseline as a covariate||||<0.32
72619361|NCT04535362|144769402|SUPERIORITY||Mean Difference (Net)|0.12|STANDARD_ERROR_OF_MEAN|0.3||0.68|TWO_SIDED||||||Mixed Models Analysis|||The fixed effects in the mixed models were infusion rate (2.5 minutes, 5 minutes and 10 minutes (placebo)), cigarette condition (menthol vs. non-menthol), and their interaction. We also controlled for order effects of cigarette condition by including session in the models Subject was a clustering factor and different variance-covariance structures were considered within each condition and subject. The best-fitting structure was selected based on Schwartz's Bayesian Criterion.||||0.68
72446585|NCT05492318|144409332|OTHER|GMR corresponds to the ratio of the Geometric LSmeans of Oral Midazolam Co-Administered with Givinostat (Day 7) and the Geometric LSmeans of Oral Midazolam Alone (Day 2)|ratio of the Geometric LSmeans|137.42|||||TWO_SIDED|90.0|128.09|147.43||||||Midazolam: Potential Inhibitory Effect of Givinostat on the Pharmacokinetics of Oral Midazolam - AUC0-t||147.43|128.09|
72446586|NCT05492318|144409332|OTHER|GMR corresponds to the ratio of the Geometric LSmeans of Oral Midazolam Co-Administered with Givinostat (Day 7) and the Geometric LSmeans of Oral Midazolam Alone (Day 2)|ratio of the Geometric LSmeans|131.21|||||TWO_SIDED|90.0|122.47|140.59||||||1-Hydroxymidazolam: Potential Inhibitory Effect of Givinostat on the Pharmacokinetics of Oral Midazolam - AUC0-t||140.59|122.47|
72446587|NCT05492318|144409332|OTHER|GMR corresponds to the ratio of the Geometric LSmeans of Oral Midazolam Co-Administered with Givinostat (Day 18) and the Geometric LSmeans of Oral Midazolam Alone (Day 2)|ratio of the Geometric LSmeans|157.77|||||TWO_SIDED|90.0|147.49|168.76||||||Midazolam: Potential Inducing Effect of Givinostat on the Pharmacokinetics of Oral Midazolam. - AUC0-t||168.76|147.49|
72446588|NCT05492318|144409332|OTHER|GMR corresponds to the ratio of the Geometric LSmeans of Oral Midazolam Co-Administered with Givinostat (Day 18) and the Geometric LSmeans of Oral Midazolam Alone (Day 2)|ratio of the Geometric LSmeans|158.3|||||TWO_SIDED|90.0|145.23|172.54||||||1-Hydroxymidazolam: Potential Inducing Effect of Givinostat on the Pharmacokinetics of Oral Midazolam: - AUC0-t||172.54|145.23|
72446589|NCT05492318|144409333|OTHER|GMR corresponds to the ratio of the Geometric LSmeans of Dabigatran Etexilate Co-Administered with Givinostat (Day 6) and the Geometric LSmeans of Dabigatran Etexilate Alone (Day 1)|ratio of the Geometric LSmeans|69.9|||||TWO_SIDED|90.0|58.43|83.64||||||Total Dabigatran: Potential Inhibitory Effect of Givinostat on the Pharmacokinetics - AUC0-t||83.64|58.43|
72446590|NCT05492318|144409333|OTHER|GMR corresponds to the ratio of the Geometric LSmeans of Dabigatran Etexilate Co-Administered with Givinostat (Day 6) and the Geometric LSmeans of Dabigatran Etexilate Alone (Day 1)|ratio of the Geometric LSmeans|71.43|||||TWO_SIDED|90.0|58.67|86.98||||||Free Dabigatran: Potential Inhibitory Effect of Givinostat on the Pharmacokinetics of Dabigatran Etexilate - AUC0-t||86.98|58.67|
72446591|NCT05492318|144409333|OTHER|GMR corresponds to the ratio of the Geometric LSmeans of Dabigatran Etexilate Co-Administered with Givinostat (Day 17) and the Geometric LSmeans of Dabigatran Etexilate Alone (Day 1)|ratio of the Geometric LSmeans|69.94|||||TWO_SIDED|90.0|58.82|83.15||||||Total Dabigatran: Potential Inducing Effect of Givinostat on the Pharmacokinetics of Dabigatran Etexilate - AUC0-t||83.15|58.82|
72446592|NCT05492318|144409333|OTHER|GMR corresponds to the ratio of the Geometric LSmeans of Dabigatran Etexilate Co-Administered with Givinostat (Day 17) and the Geometric Lsmeans of Dabigatran Etexilate Alone (Day 1)|ratio of the Geometric LSmeans|72.3|||||TWO_SIDED|90.0|59.92|87.25||||||Free Dabigatran: Potential Induction Effect of Givinostat on the Pharmacokinetics of Dabigatran Etexilate - AUC0-t||87.25|59.92|
72446593|NCT05492318|144409334|OTHER|GMR corresponds to the ratio of the Geometric LSmeans of Midazolam IV Co-Administered with Givinostat (Day 6) and the Geometric LSmeans of Midazolam of IV Alone (Day 1)|ratio of the Geometric LSmeans|107.55|||||TWO_SIDED|90.0|103.35|111.49||||||Midazolam: Potential Inhibitory Effect of Givinostat on the Pharmacokinetics of Midazolam IV: AUC0-inf||111.49|103.35|
72561039|NCT02707276|144652703|SUPERIORITY||Mean Difference (Final Values)|-1.625|STANDARD_DEVIATION|10.2|<|0.78|TWO_SIDED||||||ANCOVA|repeated measures ANCOVA|raw active-sham mean; pooled standard deviation|Repeated measures ANCOVA with baseline PANAS (Positive sub scale) scores as covariate for treatment and order effects of difference in PANAS (Positive sub scale) scores.||||<0.78
72561040|NCT02707276|144652703|SUPERIORITY||Mean Difference (Final Values)|-0.33|STANDARD_DEVIATION|2.42|<|0.99|TWO_SIDED||||||ANCOVA|baseline as covariate|pooled deviation|ANCOVA: Analysis of group differences in change scores with baseline as a covariate||||<0.99
72446594|NCT05492318|144409334|OTHER|GMR corresponds to the ratio of the Geometric LSmeans of Midazolam IV Co-Administered with Givinostat (Day 6) and the Geometric LSmeans of Midazolam of IV Alone (Day 1)|ratio of the Geometric LSmeans|112.17|||||TWO_SIDED|90.0|106.21|118.46||||||1-Hydroxymidazolam: Potential Inhibitory Effect of Givinostat on the Pharmacokinetics of Midazolam IV - AUC0-inf||118.46|106.21|
72390022|NCT02200211|144287876|SUPERIORITY|||||||0.87||||||The a priori threshold for statistical significance of the interaction term (prior amblyopia treatment and treatment group) was 0.05|ANCOVA|||Exploratory subgroup analyses were conducted to assess the treatment effect according to subgroups of baseline factors. An analysis of covariance was used to test the interaction between treatment group and prior amblyopia treatment (Yes/No), adjusting for the main effects of the interaction term and baseline covariates of age and visual acuity.||||0.87
72446595|NCT05492318|144409334|OTHER|GMR corresponds to the ratio of the Geometric LSmeans of Midazolam IV Co-Administered with Givinostat (Day 17) and the Geometric LSmeans of Midazolam of IV Alone (Day 1)|ratio of the Geometric LSmeans|124.01|||||TWO_SIDED|90.0|119.44|128.76||||||Midazolam: Potential Inducing Effect of Givinostat on the Pharmacokinetics of Midazolam IV - AUC0-inf||128.76|119.44|
72446596|NCT05492318|144409334|OTHER|GMR corresponds to the ratio of the Geometric LSmeans of Midazolam IV Co-Administered with Givinostat (Day 17) and the Geometric LSmeans of Midazolam of IV Alone (Day 1)|ratio of the Geometric LSmeans|134.29|||||TWO_SIDED|90.0|126.15|142.96||||||1-Hydroxymidazolam: Potential Inducing Effect of Givinostat on the Pharmacokinetics of Midazolam IV. AUC0-inf||142.96|126.15|
72446597|NCT05492318|144409334|OTHER|GMR corresponds to the ratio of the Geometric LSmeans of Oral Midazolam Co-Administered with Givinostat (Day 7) and the Geometric LSmeans of Oral Midazolam Alone (Day 2)|ratio of the Geometric LSmeans|138.75|||||TWO_SIDED|90.0|129.05|149.18||||||Midazolam: Potential Inhibitory Effect of Givinostat on the Pharmacokinetics of Oral Midazolam - AUC0-inf||149.18|129.05|
72446598|NCT05492318|144409334|OTHER||GMR corresponds to the ratio of the Geom|134.18|||||TWO_SIDED|90.0|124.19|144.97||||||1-Hydroxymidazolam: Potential Inhibitory Effect of Givinostat on the Pharmacokinetics of Oral Midazolam: AUC0-inf||144.97|124.19|
72561041|NCT03702816|144652721|OTHER|Linear Regression||||||0.6|||||||Regression, Linear|F=0.308||Linear Regression of Memory Composite Scores and Frontal GE180 SUVR in Control Subjects||||0.60
72390023|NCT02200211|144287876|SUPERIORITY|||||||0.33||||||The a priori threshold for statistical significance of the interaction term (baseline stereoacuity and treatment group) was 0.05.|ANCOVA|||Exploratory subgroup analyses were conducted to assess the treatment effect according to subgroups of baseline factors. An analysis of covariance was used to test the interaction between treatment group and baseline stereoacuity (nil, better than nil), adjusting for the main effects of the interaction term and baseline covariates of age and visual acuity.||||0.33
72446599|NCT05492318|144409334|OTHER|GMR corresponds to the ratio of the Geometric LSmeans of Oral Midazolam Co-Administered with Givinostat (Day 18) and the Geometric LSmeans of Oral Midazolam Alone (Day 2)|ratio of the Geometric LSmeans|162.76|||||TWO_SIDED|90.0|151.13|175.28||||||Midazolam: Potential Inducing Effect of Givinostat on the Pharmacokinetics of Oral Midazolam: AUC0-inf||175.28|151.13|
72446600|NCT05492318|144409334|OTHER|GMR corresponds to the ratio of the Geometric LSmeans of Oral Midazolam Co-Administered with Givinostat (Day 18) and the Geometric LSmeans of Oral Midazolam Alone (Day 2)|ratio of the Geometric LSmeans|161.2|||||TWO_SIDED|90.0|147.8|175.82||||||1-Hydroxymidazolam: Potential Inducing Effect of Givinostat on the Pharmacokinetics of Oral Midazolam - AUC0-inf||175.82|147.80|
72446601|NCT05492318|144409335|OTHER|GMR corresponds to the ratio of the Geometric LSmeans of Dabigatran Etexilate Co-Administered with Givinostat (Day 6) and the Geometric LSmeans of Dabigatran Etexilate Alone (Day 1)|ratio of the Geometric LSmeans|69.96|||||TWO_SIDED|90.0|58.83|83.2||||||Total Dabigatran: Potential Inhibitory Effect of Givinostat on the Pharmacokinetics of Dabigatran Etexilate - AUC0-inf||83.20|58.83|
72446602|NCT05492318|144409335|OTHER|GMR corresponds to the ratio of the Geometric LSmeans of Dabigatran Etexilate Co-Administered with Givinostat (Day 6) and the Geometric LSmeans of Dabigatran Etexilate Alone (Day 1)|ratio of the Geometric LSmeans|71.65|||||TWO_SIDED|90.0|59.08|86.88||||||Free Dabigatran: Potential Inhibitory Effect of Givinostat on the Pharmacokinetics of Dabigatran Etexilate - AUC0-inf||86.88|59.08|
72561042|NCT03702816|144652721|OTHER|Linear Regression||||||0.56|||||||Regression, Linear|F=0.367||Linear Regression of Executive Function Composite Scores and Frontal GE180 SUVR in Control Subjects||||0.56
72561043|NCT03702816|144652721|OTHER|Linear regression||||||0.44|||||||Regression, Linear|||Linear Regression of Speed Composite Scores and Frontal GE180 SUVR in Control Subjects||||0.44
72561044|NCT03702816|144652721|OTHER|Linear Regression||||||0.15|||||||Regression, Linear|F=2.55||Linear Regression of Language Composite Scores and Frontal GE180 SUVR in Control Subjects||||0.15
72561045|NCT03702816|144652721|OTHER|Linear Regression||||||0.39|||||||Regression, Linear|F=0.947||Linear Regression of Memory Composite Scores and Frontal GE180 SUVR in MCI Subjects||||0.39
72369999|NCT00505778|144250418|NON_INFERIORITY_OR_EQUIVALENCE|To establish non-inferiority for primary efficacy variable at 2-sided upper confidence bound of 95% with 90% power, 442 patients per treatment group were required to be analyzable for primary efficacy analysis. Assuming 10% enrolled would not be analyzable, 1000 patients would be enrolled. If the 95% confidence interval's upper bound interval for the difference between the Asacol BID and Asacol QD group is \<10%, then non-inferiority of Asacol QD is claimed.|BID-QD Difference in Remission Rates|1.3||||0.5016|TWO_SIDED|95.0|-2.3|4.9|||Cochran-Mantel-Haenszel|Stratified by prior Asacol dose Category||Assumed true remission rate is 70% with no difference in remission rates between QD and BID dosing.The non-inferiority margin used in hypothesis testing was set to 10%.||4.9|-2.3|0.5016
72390024|NCT02200211|144287876|SUPERIORITY|||||||0.23||||||The a priori threshold for statistical significance of the interaction term (presence of a near heterotropia at baseline and treatment group) was 0.05.|ANCOVA|||Exploratory subgroup analyses were conducted to assess the treatment effect according to subgroups of baseline factors. An analysis of covariance was used to test the interaction between treatment group and presence of a near heterotropia (measured by SPCT) at baseline (Yes/No), adjusting for the main effects of the interaction term and baseline covariates of age and visual acuity.||||0.23
72390025|NCT02200211|144287881|SUPERIORITY|||||||0.66||||||The a priori threshold for statistical significance was 0.05.|Wilcoxon (Mann-Whitney)|||The Wilcoxon rank-sum test was used to compare the distribution of change in stereoacuity levels from baseline to 16 weeks by treatment group.||||0.66
72390026|NCT02200211|144287881|SUPERIORITY|||||||0.83||||||A priori threshold for statistical significance was 0.05|Wilcoxon (Mann-Whitney)|||The Wilcoxon rank-sum test was used to compare the distribution of change in stereoacuity levels from baseline to 16 weeks by treatment group.||||0.83
72390027|NCT02200211|144287882|SUPERIORITY|||||||0.19||||||The a priori threshold for statistical significance was 0.05.|Wilcoxon (Mann-Whitney)|||The Wilcoxon rank-sum test was used to compare the distribution of change in stereoacuity levels from baseline to 16 weeks by treatment group.||||0.19
72390028|NCT02200211|144287882|SUPERIORITY|||||||0.69||||||A priori threshold for statistical significance was 0.05.|Wilcoxon (Mann-Whitney)|||The Wilcoxon rank-sum test was used to compare the distribution of change in stereoacuity levels from baseline to 16 weeks by treatment group.||||0.69
72561046|NCT03702816|144652721|OTHER|Linear Regression||||||0.95|||||||Regression, Linear|F=0.004||Linear Regression of Executive Function Composite Scores and Frontal GE180 SUVR in MCI Subjects||||0.95
72561047|NCT03702816|144652721|OTHER|Linear Regulation||||||0.53|||||||Regression, Linear|F=0.483||Linear Regression of Speed Composite Scores and Frontal GE180 SUVR in MCI Subjects||||0.53
72561048|NCT03702816|144652721|OTHER|Linear Regression||||||0.19|||||||Regression, Linear|F=2.543||Linear Regression of Language Composite Scores and Frontal GE180 SUVR in MCI Subjects||||0.19
72561049|NCT03702816|144652721|OTHER|Linear Regression||||||0.32|||||||Regression, Linear|F=3.430||Linear Regression of Memory Composite Scores and Frontal GE180 SUVR in AD Subjects||||0.32
72561050|NCT03702816|144652721|OTHER|Linear Regression||||||0.11|||||||Regression, Linear|F=32.844||Linear Regression of Executive Function Composite Scores and Frontal GE180 SUVR in AD Subjects||||0.11
72561051|NCT03702816|144652721|OTHER|Linear Regression||||||0.31|||||||Regression, Linear|F=3.559||Linear Regression of Speed Composite Scores and Frontal GE180 SUVR in AD Subjects||||0.31
72390029|NCT02200211|144287888|SUPERIORITY||Mean Difference (Final Values)|0.16|||||TWO_SIDED|95.0|0.02|0.3|||||A 95% confidence interval was computed on the adjusted treatment group difference (binocular treatment - patching) in mean change in fellow-eye visual acuity from baseline to 16 weeks. Positive values favor the binocular treatment group.|The treatment group difference in the change in fellow-eye visual acuity from baseline to 16 weeks (logMAR lines) was evaluated in an analysis of covariance model, adjusted for baseline fellow-eye visual acuity.||0.30|0.02|
72561052|NCT03702816|144652721|OTHER|Linear Regression||||||0.005|||||||Regression, Linear|F=14362.699||Linear Regression of Language Composite Scores and Frontal GE180 SUVR in AD Subjects||||0.005
72561053|NCT03702816|144652721|OTHER|Linear Regression||||||0.84|||||||Regression, Linear|F=0.056||Linear Regression of Memory Composite Scores and Frontal GE180 SUVR in PD Subjects||||0.84
72561054|NCT03702816|144652721|OTHER|Linear Regression||||||0.94|||||||Regression, Linear|F=0.008||Linear Regression of Executive Function Composite Scores and Frontal GE180 SUVR in PD Subjects||||0.94
72561055|NCT03702816|144652721|OTHER|Linear Regression||||||0.29|||||||Regression, Linear|F=2.01||Linear Regression of Speed Composite Scores and Frontal GE180 SUVR in PD Subjects||||0.29
72446603|NCT05492318|144409335|OTHER|GMR corresponds to the ratio of the Geometric LSmeans of Dabigatran Etexilate Co-Administered with Givinostat (Day 17) and the Geometric LSmeans of Dabigatran Etexilate Alone (Day 1)|ratio of the Geometric LSmeans|70.37|||||TWO_SIDED|90.0|59.64|83.03||||||Total Dabigatran: Potential Inducing Effect of Givinostat on the Pharmacokinetics of Dabigatran Etexilate - AUC0-inf||83.03|59.64|
72561056|NCT03702816|144652721|OTHER|Linear Regression||||||0.72|||||||Regression, Linear|F=0.173||Linear Regression of Language Composite Scores and Frontal GE180 SUVR in PD Subjects||||0.72
72390030|NCT02200211|144287889|SUPERIORITY||Mean Difference (Final Values)|0.1|||||TWO_SIDED|95.0|-1.1|1.3|||||A 95% confidence interval was computed on the treatment group difference (binocular treatment - patching) of the adjusted mean change in fellow-eye visual acuity from baseline to 16 weeks.|An analysis of covariance (ANCOVA) model was used to compute the treatment group difference in the mean change in fellow-eye visual acuity (letters) from baseline to 16 weeks, adjusting for baseline visual acuity. A 2-sided 95% confidence interval was computed on the adjusted treatment group difference.||1.3|-1.1|
72390031|NCT02200211|144287890|SUPERIORITY|||||||0.32|||||||Fisher Exact|||Fisher's exact test was used to perform the treatment group comparison of the proportion of participants who developed a new ocular deviation and/or worsening of a pre-existing ocular deviation by 10 prism diopters at the 16-week visit.||||0.32
72390032|NCT02200211|144287890|SUPERIORITY|||||||0.68|||||||Fisher Exact|||Fisher's exact test was used to perform the treatment group comparison of the proportion of participants who developed a new ocular deviation and/or worsening of a pre-existing ocular deviation by 10 prism diopters at the 16-week visit.||||0.68
72390033|NCT02200211|144287891|SUPERIORITY|||||||0.17|||||||Fisher Exact|||The Fisher exact test was used to compare the percentage of parents who reported that their child had experienced diplopia (yes/no) at the 16-week visit by treatment group.||||0.17
72390034|NCT02200211|144287891|SUPERIORITY|||||||0.48|||||||Cochran-Armitage trend test|||The frequency of diplopia, across categories of diplopia, was compared between the treatment groups using the Cochran-Armitage trend test.||||0.48
72390035|NCT02200211|144287891|SUPERIORITY||||||>|0.99|||||||Fisher Exact|||The Fisher exact test was used to compare the percentage of parents who reported that their child had experienced diplopia (yes/no) at the 16-week visit by treatment group.||||>0.99
72390036|NCT02200211|144287891|SUPERIORITY||||||>|0.99|||||||Cochran-Armitage trend test|||The frequency of diplopia, across categories of diplopia, was compared between the treatment groups using the Cochran-Armitage trend test.||||>0.99
72390037|NCT02200211|144287892|SUPERIORITY|||||||0.05|||||||Fisher Exact|||The Fisher exact test was used to compare the percentage of participants who reported diplopia (yes/no) at the 16-week visit by treatment group.||||0.05
72390038|NCT02200211|144287892|SUPERIORITY|||||||0.02|||||||Cochran-Armitage trend test|||The frequency of diplopia, across categories of diplopia, was compared between the treatment groups using the Cochran-Armitage trend test.||||0.02
72390039|NCT02200211|144287892|SUPERIORITY||||||>|0.99|||||||Fisher Exact|||The Fisher exact test was used to compare the percentage of participants who reported diplopia (yes/no) at the 16-week visit by treatment group.||||>0.99
72390040|NCT02200211|144287892|SUPERIORITY||||||>|0.99|||||||Cochran-Armitage trend test|||The frequency of diplopia, across categories of diplopia, was compared between the treatment groups using the Cochran-Armitage trend test.||||>0.99
72390041|NCT01918774|144287895|OTHER|Pre-post analysis comparing weeks worked in the 6 months preceding baseline and the 6 month study follow-up.|||||<|0.001||||||A priori threshold of significance was p\<.05|within groups t-test|||||||<.001
72390042|NCT01135420|144287915|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.4|||<|0.05|TWO_SIDED||||||ANCOVA|||||||<.05
72390043|NCT00717197|144287916|SUPERIORITY_OR_OTHER||Percentage|21.7|STANDARD_ERROR_OF_MEAN|7.27|||TWO_SIDED|95.0|7.46|43.7||||||||43.7|7.46|
72390044|NCT01258582|144287937|SUPERIORITY_OR_OTHER||difference in the acceptance rates|-0.022||||0.34|TWO_SIDED|95.0|-0.067|0.023|||Chi-squared|The difference in the acceptance rates was estimated along with 95% confidence intervals and tested using the chi-square test.||Sample size was chosen to detect a 10% difference in acceptance rates between two testing modality arms (90% power, 0.05 level of significance).||0.023|-0.067|0.34
72390045|NCT00674700|144288009|SUPERIORITY_OR_OTHER|||||||0.0066||||||main effects = treatment and pools of study centers, Covariates = age, gender, asthma status, sensitization status and baseline ARTSS|ANCOVA|||||||0.0066
72390046|NCT00674700|144288009|SUPERIORITY_OR_OTHER|||||||0.015||||||main effects= treatment and pools of study centers, Covariates = age, gender, asthma status, sensitization status and baseline ARTSS|ANCOVA|||||||0.015
72390047|NCT00674700|144288010|SUPERIORITY_OR_OTHER|||||||0.0086|||||||ANCOVA|||||||0.0086
72390048|NCT00674700|144288010|SUPERIORITY_OR_OTHER|||||||0.0095|||||||ANCOVA|||||||0.0095
72390049|NCT02417831|144288060|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence range of 80% to 125%.|Ratio|105.76|STANDARD_DEVIATION|14.18|||TWO_SIDED|90.0|99.81|112.08|||||The standard deviation in the statistical analysis is actually the intra-individual coefficient of variation. Ratio calculated as test divided by reference.|||112.08|99.81|
72390050|NCT02417831|144288061|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence range of 80% to 125%.|Ratio|101.4|STANDARD_DEVIATION|9.05|||TWO_SIDED|90.0|97.71|105.23|||||The standard deviation in the statistical analysis is actually the intra-individual coefficient of variation. Ratio calculated as test divided by reference.|||105.23|97.71|
72390051|NCT02417831|144288062|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence range of 80% to 125%.|Ratio|101.42|STANDARD_DEVIATION|8.85|||TWO_SIDED|90.0|97.81|105.17|||||The standard deviation in the statistical analysis is actually the intra-individual coefficient of variation. Ratio calculated as test divided by reference.|||105.17|97.81|
72446604|NCT05492318|144409335|OTHER|GMR corresponds to the ratio of the Geometric LSmeans of Dabigatran Etexilate Co-Administered with Givinostat (Day 17) and the Geometric Lsmeans of Dabigatran Etexilate Alone (Day 1)|ratio of the Geometric LSmeans|73.45|||||TWO_SIDED|90.0|60.79|88.75||||||Free Dabigatran: Potential Induction Effect of Givinostat on the Pharmacokinetics of Dabigatran Etexilate. AUC0-inf||88.75|60.79|
72561057|NCT03702816|144652722|OTHER|Linear Regression||||||0.54|||||||Regression, Linear|F=0.424||Linear Regression of Memory Composite Scores and Cingulate GE180 SUVR in Control Subjects||||0.54
72561058|NCT03702816|144652722|OTHER|Linear Regression||||||0.53|||||||Regression, Linear|F=0.447||Linear Regression of Executive Function Composite Scores and Cingulate GE180 SUVR in Control Subjects||||0.53
72446605|NCT05235750|144409442|OTHER||Mean Difference (Net)|0.2||||0.83|TWO_SIDED|||||The above p value refers to the difference between post-intervention change and pre-intervention change (or \[(T3-T2)-(T2-T1)\]) for RSES.|Mixed Models Analysis||The above value represents net difference between post-intervention change and pre-intervention change (or \[(T3-T2)-(T2-T1)\]) for RSES.|We analyzed short- (at 6 weeks post-baseline or T3) and longer-term differences (at 8 weeks post-baseline or T4) for the RSES, expecting a larger size of differences at T3. The short-term difference \[(T3-T2)-(T2-T1)\] represents differences between post-intervention change (T3-T2) and pre-intervention change (T2-T1). Longer-term difference \[(T4-T2)-(T2-T1)\] represents differences between 2 weeks post-intervention change (T4-T2) and pre-intervention change (T2-T1).||||.83
72446606|NCT05235750|144409442|OTHER||Mean Difference (Net)|-0.2||||0.91|TWO_SIDED|||||The above p value refers to the difference between 2 weeks post-intervention change and pre-intervention change (or \[(T4-T2)-(T2-T1)\]) for RSES.|Mixed Models Analysis||The above value represents net difference between 2 weeks post-intervention change and pre-intervention change (or \[(T4-T2)-(T2-T1)\]) for RSES.|||||.91
72446607|NCT05235750|144409443|OTHER||Mean Difference (Net)|-2.1||||0.45|TWO_SIDED|||||The above p value refers to the difference between post-intervention change and pre-intervention change (or \[(T3-T2)-(T2-T1)\]) for the total FACT-G.|Mixed Models Analysis||The above value represents net difference between post-intervention change and pre-intervention change (or \[(T3-T2)-(T2-T1)\]) for the total FACT-G.|We analyzed short- (at 6 weeks post-baseline, T3) and longer-term differences (at 8 weeks post-baseline, T4) for the FACT-G at scale, factor and item levels expecting a larger size of differences at T3. The short-term difference \[(T3-T2)-(T2-T1)\] represents differences between post-intervention change (T3-T2) and pre-intervention change (T2-T1). Longer-term difference \[(T4-T2)-(T2-T1)\] represents differences between 2 weeks post-intervention change (T4-T2) and pre-intervention change (T2-T1).||||.45
72446608|NCT05235750|144409443|OTHER||Mean Difference (Net)|-3.3||||0.29|TWO_SIDED|||||The above p value refers to the difference between 2 weeks post-intervention change and pre-intervention change (or \[(T4-T2)-(T2-T1)\]) for the total FACT-G.|Mixed Models Analysis||The above value represents net difference between 2 weeks post-intervention change and pre-intervention change (or \[(T4-T2)-(T2-T1)\]) for the total FACT-G.|||||.29
72446609|NCT05235750|144409443|OTHER||Mean Difference (Net)|0.8||||0.46|TWO_SIDED|||||The above p value refers to the difference between post-intervention change and pre-intervention change (or \[(T3-T2)-(T2-T1)\]) for physical well-being (PWB) as measured by the FACT-G.|Mixed Models Analysis||The above value represents net difference between post-intervention change and pre-intervention change (or \[(T3-T2)-(T2-T1)\]) for physical well-being (PWB) as measured by the FACT-G.|||||.46
72446610|NCT05235750|144409443|OTHER||Mean Difference (Net)|0.2||||0.79|TWO_SIDED|||||The above p value refers to the difference between 2 weeks post-intervention change and pre-intervention change (or \[(T4-T2)-(T2-T1)\]) for physical well-being (PWB) as measured by the FACT-G.|Mixed Models Analysis||The above value represents net difference between 2 weeks post-intervention change and pre-intervention change (or \[(T4-T2)-(T2-T1)\]) for physical well-being (PWB) as measured by the FACT-G.|||||.79
72446611|NCT05235750|144409443|OTHER||Mean Difference (Net)|-2.1||||0.05|TWO_SIDED|||||The above p value refers to the difference between post-intervention change and pre-intervention change (or \[(T3-T2)-(T2-T1)\]) for social/family well-being (SWB) as measured by the FACT-G.|Mixed Models Analysis||The above value represents net difference between post-intervention change and pre-intervention change (or \[(T3-T2)-(T2-T1)\]) for social/family well-being (SWB) as measured by the FACT-G.|||||.05
72446612|NCT05235750|144409443|OTHER||Mean Difference (Net)|-2.4||||0.03|TWO_SIDED|||||The above p value refers to the difference between 2 weeks post-intervention change and pre-intervention change (or \[(T4-T2)-(T2-T1)\]) for social/family well-being (SWB) as measured by the FACT-G.|Mixed Models Analysis||The above value represents net difference between 2 weeks post-intervention change and pre-intervention change (or \[(T4-T2)-(T2-T1)\]) for social/family well-being (SWB) as measured by the FACT-G.|||||.03
72446613|NCT05235750|144409443|OTHER||Mean Difference (Net)|-0.2||||0.82|TWO_SIDED|||||The above p value refers to the difference between post-intervention change and pre-intervention change (or \[(T3-T2)-(T2-T1)\]) for emotional well-being (EWB) as measured by the FACT-G.|Mixed Models Analysis||The above value represents net difference between post-intervention change and pre-intervention change (or \[(T3-T2)-(T2-T1)\]) for emotional well-being (EWB) as measured by the FACT-G.|||||.82
72446614|NCT05235750|144409443|OTHER||Mean Difference (Net)|-0.5||||0.58|TWO_SIDED|||||The above p value refers to the difference between 2 weeks post-intervention change and pre-intervention change (or \[(T4-T2)-(T2-T1)\]) for emotional well-being (EWB) as measured by the FACT-G.|Mixed Models Analysis||The above value represents net difference between 2 weeks post-intervention change and pre-intervention change (or \[(T4-T2)-(T2-T1)\]) for emotional well-being (EWB) as measured by the FACT-G.|||||.58
72446615|NCT05235750|144409443|OTHER||Mean Difference (Net)|-0.8||||0.56|TWO_SIDED|||||The above p value refers to the difference between post-intervention change and pre-intervention change (or \[(T3-T2)-(T2-T1)\]) for functional well-being (FWB) as measured by the FACT-G.|Mixed Models Analysis||The above value represents net difference between post-intervention change and pre-intervention change (or \[(T3-T2)-(T2-T1)\]) for functional well-being (FWB) as measured by the FACT-G.|||||.56
72446616|NCT05235750|144409443|OTHER||Mean Difference (Net)|-0.7||||0.58|TWO_SIDED|||||The above p value refers to the difference between 2 weeks post-intervention change and pre-intervention change (or \[(T4-T2)-(T2-T1)\]) for functional well-being (FWB) as measured by the FACT-G.|Mixed Models Analysis||The above value represents net difference between 2 weeks post-intervention change and pre-intervention change (or \[(T4-T2)-(T2-T1)\]) for functional well-being (FWB) as measured by the FACT-G.|||||.58
72446617|NCT05235750|144409443|OTHER||Mean Difference (Net)|-0.2||||0.58|TWO_SIDED|||||"The above p value refers to the difference between post-intervention change and pre-intervention change (or \[(T3-T2)-(T2-T1)\]) for Global QoL (item G7 I am content with the quality of my life right now) as measured by the FACT-G."|Mixed Models Analysis||"The above value represents net difference between post-intervention change and pre-intervention change (or \[(T3-T2)-(T2-T1)\]) for Global QoL (item G7 I am content with the quality of my life right now) as measured by the FACT-G."|||||.58
72561059|NCT03702816|144652722|OTHER|Linear Regression||||||0.23|||||||Regression, Linear|F=1.773||Linear Regression of Speed Composite Scores and Cingulate GE180 SUVR in Control Subjects||||0.23
72561060|NCT03702816|144652722|OTHER|Linear Regression||||||0.01|||||||Regression, Linear|F=3.615||Linear Regression of Language Composite Scores and Cingulate GE180 SUVR in Control Subjects||||0.01
72446618|NCT05235750|144409443|OTHER||Mean Difference (Net)|-0.3||||0.34|TWO_SIDED|||||"The above p value refers to the difference between 2 weeks post-intervention change and pre-intervention change (or \[(T4-T2)-(T2-T1)\] for Global QoL (item G7 I am content with the quality of my life right now) as measured by the FACT-G."|Mixed Models Analysis||"The above value represents net difference between 2 weeks post-intervention change and pre-intervention change (or \[(T4-T2)-(T2-T1)\]) for Global QoL (item G7 I am content with the quality of my life right now) as measured by the FACT-G."|||||.34
72446619|NCT05235750|144409443|OTHER||Mean Difference (Net)|0.4||||0.27|TWO_SIDED|||||"The above p value refers to the difference between post-intervention change and pre-intervention change (or \[(T3-T2)-(T2-T1)\]) for item Ge6 I worry that my condition will get worse as measured by the FACT-G."|Mixed Models Analysis||"The above value represents net difference between post-intervention change and pre-intervention change (or \[(T3-T2)-(T2-T1)\]) for item Ge6 I worry that my condition will get worse as measured by the FACT-G."|||||.27
72395197|NCT05355805|144297051|SUPERIORITY||Risk Difference (RD)|8.27|STANDARD_ERROR_OF_MEAN|8.075||0.3055|TWO_SIDED|||||The estimated risk difference divided by the standard error was used as the test statistic and a p-value calculated assuming that the test statistic follows a standard normal distribution under the null hypothesis.|Cochran-Mantel-Haenszel|||"The common risk difference between placebo QW/Q2W and the izokibep 160 mg QW arm among the four strata, prior biologic/Janus Kinase (JAK) inhibitor use for HS (Yes/No) and Hurley Stage (II or III), used for randomization and associated standard error was estimated by combining the observed risk differences using Cochran-Mantel-Haenszel weighting.~Non-response imputation was used for participants with missing HiSCR75."||||0.3055
72497939|NCT01256177|144526249|SUPERIORITY_OR_OTHER||Least Square Mean difference vs Placebo|-0.51|STANDARD_ERROR_OF_MEAN|0.17||0.003|TWO_SIDED|95.0|-0.84|-0.17|||Mixed Model Repeated Measures (MMRM)|Baseline CGI-BP-S score for overall BP illness as covariate, trt, bipolar strata, visit, trt-visit interaction as fixed effect and centre as random.||Change from baseline to Week 8 assessment in the CGI-BP-S score for overall Bipolar (BP) illness based on observed cases (OC)||-0.17|-0.84|0.003
72497940|NCT01256177|144526249|SUPERIORITY_OR_OTHER||Least Square Mean difference vs Placebo|-0.47|STANDARD_ERROR_OF_MEAN|0.17||0.007|TWO_SIDED|95.0|-0.81|-0.13|||Mixed Model Repeated Measures (MMRM)|Baseline CGI-BP-S score for depression as covariate, trt, Bipolar strata, visit, trt-visit interaction as fixed effects and centre as random.||Change from Baseline to Week 8 assessment in the CGI-BP-S score of depression based on observed cases (OC)||-0.13|-0.81|0.007
72497941|NCT01256177|144526250|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.06||||0.004|TWO_SIDED|95.0|1.26|3.36|||Regression, Logistic|Odds ratio between treatment groups was modeled by logistic regression adjusted for centre, baseline score and bipolar Strata.|Quetiapine XR/Placebo|||3.36|1.26|0.004
72497942|NCT01256177|144526251|SUPERIORITY_OR_OTHER||Least Square Mean difference vs Placebo|-0.22|STANDARD_ERROR_OF_MEAN|0.08||0.005|TWO_SIDED|95.0|-0.38|-0.07|||Mixed Model Repeated Measures (MMRM)|Baseline MADRS item 10 score as covariate, treatment, bipolar strata, visit, treatment-visit interaction as fixed effect and centre as random.||Change from Baseline to Week 8 in MADRS item 10 score for suicidal ideation based on observed cases (OC)||-0.07|-0.38|0.005
72561061|NCT03702816|144652722|OTHER|Linear Regression||||||0.039|||||||Regression, Linear|F=9.204||Linear Regression of Memory Composite Scores and Cingulate GE180 SUVR in MCI Subjects||||0.039
72561062|NCT03702816|144652722|OTHER|Linear Regression||||||0.33|||||||Regression, Linear|F=1.209||Linear Regression of Executive Function Composite Scores and Cingulate GE180 SUVR in MCI Subjects||||0.33
72497943|NCT01256177|144526252|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.26||||0.233|TWO_SIDED|95.0|0.03|2.38|||Regression, Logistic|Odds ratio between treatment groups was modeled by logistic regression adjusted for centre, strata and baseline score.|Quetiapine XR/Placebo|||2.38|0.03|0.233
72497944|NCT01110395|144526253|OTHER|Bland and Altman|Mean + SD|0.05|STANDARD_ERROR_OF_MEAN|1.96|||TWO_SIDED|||||Bland Altman|mean + SD|Bland Altman|We have provided all the information that is available to us. The PI has left the institution and we are unable to contact him. We have no further data to correct the errors.|We are unable to provide any further data that has been requested. We have supplied all the data that we can possibly provide because the PI has left the institution and we are unable to contact him. We have no other data.|There are no other statistical analysis. We have provided all the information that is available to us. We have no other data available to us because the PI has left the institution and we are unable to contact him.|||
72497945|NCT01110395|144526253|OTHER||||||<|0.05|||||||Mean + SD|||||||<0.05
72497946|NCT04398732|144526264|OTHER|||||||0.0001|||||||Student's t-test|||Statistical analysis was performed on change from Baseline in percent BSA at Month 12.||||0.0001
72561063|NCT03702816|144652722|OTHER|Linear Regression||||||0.07|||||||Regression, Linear|F=5.801||Linear Regression of Speed Composite Scores and Cingulate GE180 SUVR in MCI Subjects||||0.07
72561064|NCT03702816|144652722|OTHER|Linear Regression||||||0.03|||||||Regression, Linear|F=10.374||Linear Regression of Language Composite Scores and Cingulate GE180 SUVR in MCI Subjects||||0.03
72561065|NCT03702816|144652722|OTHER|Linear Regression||||||0.27|||||||Regression, Linear|F=5.024||Linear Regression of Memory Composite Scores and Cingulate GE180 SUVR in AD Subjects||||0.27
72561066|NCT03702816|144652722|OTHER|Linear Regression||||||0.16|||||||Regression, Linear|F=15.568||Linear Regression of Executive Function Composite Scores and Cingulate GE180 SUVR in AD Subjects||||0.16
72446620|NCT05235750|144409443|OTHER||Mean Difference (Net)|0.0||||0.62|TWO_SIDED|||||"The above p value refers to the difference between 2 weeks post-intervention change and pre-intervention change (or \[(T4-T2)-(T2-T1)\]) for item Ge6 I worry that my condition will get worse as measured by the FACT-G."|Mixed Models Analysis||"The above value represents net difference between 2 weeks post-intervention change and pre-intervention change (or \[(T4-T2)-(T2-T1)\]) for item Ge6 I worry that my condition will get worse as measured by the FACT-G."|||||.62
72561067|NCT03702816|144652722|OTHER|Linear Regression||||||0.262|||||||Regression, Linear|F=5.238||Linear Regression of Speed Composite Scores and Cingulate GE180 SUVR in AD Subjects||||0.262
72561068|NCT03702816|144652722|OTHER|Linear Regression||||||0.043|||||||Regression, Linear|F=221.308||Linear Regression of Language Composite Scores and Cingulate GE180 SUVR in AD Subjects||||0.043
72561069|NCT03702816|144652722|OTHER|Linear Regression||||||0.26|||||||Regression, Linear|F=2.430||Linear Regression of Memory Composite Scores and Cingulate GE180 SUVR in PD Subjects||||0.26
72561070|NCT03702816|144652722|OTHER|Linear Regression||||||0.38|||||||Regression, Linear|F=1.269||Linear Regression of Executive Function Composite Scores and Cingulate GE180 SUVR in PD Subjects||||0.38
72446621|NCT05235750|144409444|OTHER||Mean Difference (Net)|-0.6||||0.76|TWO_SIDED|||||The above p value refers to the difference between post-intervention change and pre-intervention change (or \[(T3-T2)-(T2-T1)\]) for the total FACIT-Sp-12.|Mixed Models Analysis||The above value represents net difference between post-intervention change and pre-intervention change (or \[(T3-T2)-(T2-T1)\]) for the total FACIT-Sp-12.|We analyzed short- (at 6 weeks post-baseline, T3) and longer-term differences (at 8 weeks post-baseline, T4) for the FACIT-Sp-12 at scale and factor levels, expecting a larger size of differences at T3. The short-term difference \[(T3-T2)-(T2-T1)\] represents differences between post-intervention change (T3-T2) and pre-intervention change (T2-T1). Longer-term difference \[(T4-T2)-(T2-T1)\] represents differences between 2 weeks post-intervention change (T4-T2) and pre-intervention change (T2-T1).||||.76
72561071|NCT03702816|144652722|OTHER|Linear Regression||||||0.07|||||||Regression, Linear|F=13.164||Linear Regression of Speed Composite Scores and Cingulate GE180 SUVR in PD Subjects||||0.07
72561072|NCT03702816|144652722|OTHER|Linear Regression||||||0.37|||||||Regression, Linear|F=1.312||Linear Regression of Language Composite Scores and Cingulate GE180 SUVR in PD Subjects||||0.37
72561073|NCT03702816|144652723|OTHER|Linear Regression||||||0.64|||||||Regression, Linear|F=0.233||Linear Regression of Memory Composite Scores and Parietal GE180 SUVR in Control Subjects||||0.64
72561074|NCT03702816|144652723|OTHER|Linear Regression||||||0.92|||||||Regression, Linear|F=0.011||Linear Regression of Executive Function Composite Scores and Parietal GE180 SUVR in Control Subjects||||0.92
72561075|NCT03702816|144652723|OTHER|Linear Regression||||||0.22|||||||Regression, Linear|F=1.790||Linear Regression of Speed Composite Scores and Parietal GE180 SUVR in Control Subjects||||0.22
72561076|NCT03702816|144652723|OTHER|Linear Regression||||||0.42|||||||Regression, Linear|F=0.720||Linear Regression of Language Composite Scores and Parietal GE180 SUVR in Control Subjects||||0.42
72561077|NCT03702816|144652723|OTHER|Linear Regression||||||0.61|||||||Regression, Linear|F=0.305||Linear Regression of Memory Composite Scores and Parietal GE180 SUVR in MCI Subjects||||0.61
72561078|NCT03702816|144652723|OTHER|Linear Regression||||||0.95|||||||Regression, Linear|F=0.005||Linear Regression of Executive Function Composite Scores and Parietal GE180 SUVR in MCI Subjects||||0.95
72390052|NCT01144286|144288070|SUPERIORITY_OR_OTHER||response rate (%)|80.0||||0.063|TWO_SIDED|95.0||||Significance level was set to α of 0.05 if the primary endpoint was significant, hierarchical testing was to be performed on the primary endpoint (each active dose X placebo). No other adjustment was made for testing multiple secondary outcomes.|Regression, Logistic|||"Primary analysis is the dose response at TOC based on the global therapeutic cure. Dose response will be tested using a logistic regression using linear coefficient for the treatment effect(Wald chi-square).~Assuming that the response rate is 80% for 600 mg, 75% for the 300 mg, 65% for 150 mg and 50% for the placebo group, a sample size of 45 subjects in each group will have 90% power to detect a linear dose response using a 0.05 two-sided test of trend based on the logistic model."||||0.0630
72390053|NCT01867424|144288104|OTHER||Median of Differences|0.43||||0.0008|TWO_SIDED|||||Median of difference in CER: All cases.|Wilcoxon Test||The relative difference between groups is based on the change from baseline values to the values collected at each of the three time points.|Null Hypothesis: There is no significant difference in contrast enhancement ratio (CER) in prostate cancers upon injection of Eovist. Subgroup analysis of CER in (i) Advanced Disease and (ii) Localized Disease||||0.0008
72390054|NCT01867424|144288104|OTHER||Median of Differences|0.42||||0.0039|TWO_SIDED|||||Median of difference in CER: Advanced Disease Cases.|Wilcoxon Test|||||||0.0039
72390055|NCT01867424|144288104|OTHER||Median of Differences|0.475||||0.084|TWO_SIDED|||||Median of difference in CER: Local Disease Cases.|Wilcoxon Test|||||||0.084
72390056|NCT01867424|144288104|OTHER||Median Difference CER|0.17||||0.25|TWO_SIDED||||||Wilcoxon Test|||Analysis of CER from baseline to 40 minutes after Eovist injection.||||0.25
72390057|NCT01867424|144288104|OTHER||Median Difference CER|0.27||||0.1602|TWO_SIDED||||||Wilcoxon Test|||Analysis of CER from baseline to 60 minutes after Eovist injection.||||0.1602
72390058|NCT01867424|144288104|OTHER||Median Difference CER|0.29||||0.0078|TWO_SIDED||||||Wilcoxon Test|||Analysis of CER from baseline to 40 minutes after Eovist injection.||||0.0078
72390059|NCT01867424|144288104|OTHER||Median Difference CER|0.34||||0.0039|TWO_SIDED||||||Wilcoxon Test|||Analysis of CER from baseline to 60 minutes after Eovist injection.||||0.0039
72561079|NCT03702816|144652723|OTHER|Linear Regression||||||0.55|||||||Regression, Linear|F=0.435||Linear Regression of Speed Composite Scores and Parietal GE180 SUVR in MCI Subjects||||0.55
72561080|NCT03702816|144652723|OTHER|Linear Regression||||||0.43|||||||Regression, Linear|F=0.787||Linear Regression of Language Composite Scores and Parietal GE180 SUVR in MCI Subjects||||0.43
72561081|NCT03702816|144652723|OTHER|Linear Regression||||||0.036|||||||Regression, Linear|F=316.379||Linear Regression of Memory Composite Scores and Parietal GE180 SUVR in AD Subjects||||0.036
72561082|NCT03702816|144652723|OTHER|Linear Regression||||||0.39|||||||Regression, Linear|F=2.032||Linear Regression of Executive Function Composite Scores and Parietal GE180 SUVR in AD Subjects||||0.39
72561083|NCT03702816|144652723|OTHER|Linear Regression||||||0.031|||||||Regression, Linear|F=425.337||Linear Regression of Speed Composite Scores and Parietal GE180 SUVR in AD Subjects||||0.031
72390060|NCT01867424|144288104|OTHER||Median Difference CER|0.27||||0.0046|TWO_SIDED||||||Wilcoxon Test|||Analysis of CER from baseline to 40 minutes after Eovist injection; Total cases.||||0.0046
72390061|NCT01867424|144288104|OTHER||Median Difference CER|0.33||||0.0017|TWO_SIDED||||||Wilcoxon Test|||Analysis of CER from baseline to 60 minutes after Eovist injection; Total cases.||||0.0017
72390062|NCT01867424|144288106|OTHER||Spearman r|-0.137||||0.5761|TWO_SIDED|95.0|-0.5665|0.3511|||Nonparametric Spearman correlation|The calculation of Spearman correlation is between baseline PSA and CER at 20 minutes post Eovist injection.||Null Hypothesis: There is no significant difference in contrast enhancement ratio (CER) with Eovist injection based on baseline Prostate-specific antigen (PSA) levels at 20-minute timepoint.||0.3511|-0.5665|0.5761
72561084|NCT03702816|144652723|OTHER|Linear Regression||||||0.274|||||||Regression, Linear|F=4.739||Linear Regression of Language Composite Scores and Parietal GE180 SUVR in AD Subjects||||0.274
72561085|NCT03702816|144652723|OTHER|Linear Regression||||||0.66|||||||Regression, Linear|F=0.263||Linear Regression of Memory Composite Scores and Parietal GE180 SUVR in PD Subjects||||0.66
72561086|NCT03702816|144652723|OTHER|Linear Regression||||||0.07|||||||Regression, Linear|F=12.244||Linear Regression of Executive Function Composite Scores and Parietal GE180 SUVR in PD Subjects||||0.07
72497947|NCT04398732|144526265|OTHER|||||||0.0001|||||||Student's t-test|||Statistical analysis was performed on change from baseline in DLQI at Month 12.||||0.0001
72497948|NCT04398732|144526266|OTHER|||||||0.0001|||||||Student's t-test|||Statistical analysis was performed on change from baseline in PASI at Month 12.||||0.0001
72497949|NCT04398732|144526267|OTHER|||||||0.036|||||||Student's t-test|||Baseline||||0.036
72497950|NCT04398732|144526267|OTHER|||||||0.0001|||||||Student's t-test|||Month 4||||0.0001
72497951|NCT04398732|144526267|OTHER|||||||0.0001|||||||Student's t-test|||Month 12||||0.0001
72497952|NCT04398732|144526268|OTHER|||||||0.42|||||||Student's t-test|||Baseline||||0.42
72561087|NCT03702816|144652723|OTHER|Linear Regression||||||0.48|||||||Regression, Linear|F=0.762||Linear Regression of Speed Composite Scores and Parietal GE180 SUVR in PD Subjects||||0.48
72561088|NCT03702816|144652723|OTHER|Linear Regression||||||0.12|||||||Regression, Linear|F=7.107||Linear Regression of Language Composite Scores and Parietal GE180 SUVR in PD Subjects||||0.12
72497953|NCT04398732|144526268|OTHER|||||||0.0001|||||||Student's t-test|||Month 4||||0.0001
72497954|NCT04398732|144526268|OTHER|||||||0.0001|||||||Student's t-test|||Month 12||||0.0001
72497955|NCT04398732|144526269|OTHER|||||||0.72|||||||Student's t-test|||Baseline||||0.72
72390063|NCT01867424|144288106|OTHER||Spearman r|-0.257||||0.3033|TWO_SIDED|95.0|-0.6549|0.2526|||nonparametric Spearman correlation|||Analyses include calculation of Spearman correlation between baseline Prostate-specific antigen (PSA) and CER at 40 minutes post Eovist injection.||0.2526|-0.6549|0.3033
72497956|NCT04398732|144526269|OTHER|||||||0.0001|||||||Student's t-test|||Month 4||||0.0001
72497957|NCT04398732|144526269|OTHER|||||||0.0001|||||||Student's t-test|||Month 12||||0.0001
72497958|NCT04398732|144526270|OTHER|||||||0.0001|||||||Student's t-test|||Statistical analysis was performed on change from Baseline in percent BSA at Month 4.||||0.0001
72497959|NCT04398732|144526271|OTHER|||||||0.0001|||||||Student's t-test|||Statistical analysis was performed on change from baseline in DLQI at Month 4.||||0.0001
72390064|NCT01867424|144288106|OTHER||Spearman r|-0.2861||||0.2351|TWO_SIDED|95.0|-0.6634|0.2071|||nonparametric Spearman correlation|||Analyses include calculation of Spearman correlation between baseline Prostate-specific antigen (PSA) and CER at 60 minutes post Eovist injection.||0.2071|-0.6634|0.2351
72390065|NCT01867424|144288106|OTHER||Median Difference (actual)|-0.47||||0.111|TWO_SIDED||||||Mann Whitney|||Analyses include analysis of CER at 20 minutes after Eovist injection based on baseline Prostate-specific antigen (PSA) stratifying by PSA \< or \>/= 20ng/ml.||||0.111
72390066|NCT01867424|144288106|OTHER||Median Difference (actual)|-0.775||||0.7738|TWO_SIDED||||||Mann Whitney|||Analyses include analysis of CER at 20 minutes after Eovist injection based on baseline Prostate-specific antigen (PSA) stratifying by PSA \< or \>/= 20ng/ml.||||0.7738
72497960|NCT04398732|144526272|OTHER|||||||0.0001|||||||Student's t-test|||Statistical analysis was performed on change from baseline in PASI at Month 4.||||0.0001
72497961|NCT02928952|144526283|SUPERIORITY|Assessed group by time differences from week 12 to week 24. Statistical Test of hypothesis. Analyzed as intention to treat in mixed models with imputation as last value moved forward.||||||0.153|||||||Mixed Models Analysis|All models adjusted for Age and Duration of Diabetes||The statistical analysis was applied to both groups.||||0.153
72497962|NCT02928952|144526283|SUPERIORITY|Assessed group by time differences from week 12 to week 24. Statistical Test of hypothesis. Analyzed as intention to treat in mixed models with imputation as last value moved forward.||||||0.026|||||||Mixed Models Analysis|Adjusted for age and duration of diabetes.||||||0.026
72497963|NCT02928952|144526283|SUPERIORITY|Analyzed as intention to treat in mixed models with imputation as last value moved forward.||||||0.012|||||||Mixed Models Analysis|Models adjusted for age and duration of diabetes.||Within group analysis of intervention effect on Diabetes Distress (Problem Areas in Diabetes, PAID scale) over time stratified by hemoglobin A1c\<8.5% and =/\>8.5.||||0.012
72497964|NCT02928952|144526284|SUPERIORITY|The statistical analysis was applied to both groups.||||||0.604|||||||Mixed Models Analysis|All models adjusted for age and duration of diabetes.||Statistical Test of hypothesis. Analyzed as intention to treat in mixed models with imputation as last value moved forward.||||.604
72497965|NCT02928952|144526285|SUPERIORITY|Statistical Test of hypothesis. Analyzed as intention to treat in mixed models with imputation as last value moved forward.||||||0.911|||||||Mixed Models Analysis|All models adjusted for Age and Duration of Diabetes||The statistical analysis was applied to both groups.||||0.911
72497966|NCT02928952|144526286|SUPERIORITY|Statistical Test of hypothesis. Analyzed as intention to treat in mixed models with imputation as last value moved forward.||||||0.94|||||||Mixed Models Analysis|All models were adjusted for age and duration of diabetes.||||||0.940
72497967|NCT02928952|144526287|SUPERIORITY|Statistical Test of hypothesis. Analyzed as intention to treat in mixed models with imputation as last value moved forward.||||||0.305|||||||Mixed Models Analysis|All models adjusted for Age and Duration of Diabetes||The statistical analysis was applied to both groups.||||0.305
72497968|NCT02928952|144526288|SUPERIORITY|Statistical Test of hypothesis. Analyzed as intention to treat in mixed models with imputation as last value moved forward.||||||0.228|||||||Mixed Models Analysis|All models adjusted for age and duration of diabetes.||||||0.228
72497969|NCT02928952|144526289|SUPERIORITY|Statistical Test of hypothesis. Differing sample sizes are due to attrition and missed research visits. Analyzed as intention to treat in mixed models with imputation as last value moved forward.||||||0.671|||||||Mixed Models Analysis|All models were adjusted for age and duration of diabetes.||The statistical analysis was applied to both groups.||||0.671
72497970|NCT02928952|144526290|SUPERIORITY|Statistical Test of hypothesis. Analyzed as intention to treat in mixed models with imputation as last value moved forward.||||||0.571|||||||Mixed Models Analysis|All models were adjusted for age and duration of diabetes.||The statistical analysis was applied to both groups.||||0.571
72497971|NCT02928952|144526291|SUPERIORITY|Statistical Test of hypothesis. Analyzed as intention to treat in mixed models with imputation as last value moved forward.||||||0.003|||||||Mixed Models Analysis|All models adjusted for age and duration of diabetes.||The statistical analysis was applied to both groups.||||0.003
72561089|NCT03702816|144652724|OTHER|Linear Regression||||||0.85|||||||Regression, Linear|F=0.038||Linear Regression of Memory Composite Scores and Temporal GE180 SUVR in Control Subjects||||0.85
72561090|NCT03702816|144652724|OTHER|Linear Regression||||||0.84|||||||Regression, Linear|F=0.042||Linear Regression of Executive Function Composite Scores and Temporal GE180 SUVR in Control Subjects||||0.84
72561091|NCT03702816|144652724|OTHER|Linear Regression||||||0.35|||||||Regression, Linear|F=1.021||Linear Regression of Speed Composite Scores and Temporal GE180 SUVR in Control Subjects||||0.35
72561092|NCT03702816|144652724|OTHER|Linear Regression||||||0.25|||||||Regression, Linear|F=1.610||Linear Regression of Language Composite Scores and Temporal GE180 SUVR in Control Subjects||||0.25
72390067|NCT01056653|144288108|SUPERIORITY_OR_OTHER||||||=|0.03|||||||ANCOVA|F(2,107)=3.48, partial n2=0.061, observed power=0.639||ANCOVA - Group Comparison of Parent Total Score on PCITS at 8 months, controlling for scores at baseline (4 months). Group entered as as fixed factor, outcome scores as dependent variable, and baseline scores as covariate.||||=0.03
72390068|NCT01056653|144288108|SUPERIORITY_OR_OTHER|||||||0.03||||||Bonferroni adjustments for multiple comparisons used|ANOVA|||Pairwise Group Comparison based on estimated marginal means - Parent Total Scores||||0.03
72390069|NCT01056653|144288108|SUPERIORITY_OR_OTHER|||||||0.534||||||Bonferroni adjustment for multiple comparisons used|ANCOVA|||Pairwise Group Comparison based on estimated marginal means - Parent Total Scores||||0.534
72390070|NCT01056653|144288108|SUPERIORITY_OR_OTHER|||||||0.047|||||||ANCOVA|F(2,107)=3.145, partial n2=0.056, observed power=0.593.||ANCOVA - Group Comparison of Cognitive Growth Fostering Subscale scores at 8 months, controlling for scores at baseline (4 months). Group entered as fixed factor, outcome scores as dependent variable, and baseline scores as covariate.||||0.047
72390071|NCT01056653|144288108|SUPERIORITY_OR_OTHER|||||||0.056||||||Bonferroni adjustments for multiple comparisons used|ANCOVA|||Pairwise Group Comparison based on estimated marginal means - Cognitive Growth Fostering Subscale||||0.056
72390072|NCT01056653|144288108|SUPERIORITY_OR_OTHER|||||||0.267||||||Bonferroni adjustments for multiple comparisons used|ANCOVA|||Pairwise Group Comparison based on estimated marginal means - Cognitive Growth Fostering Subscale||||0.267
72390073|NCT01056653|144288108|SUPERIORITY_OR_OTHER|||||||0.036|||||||ANCOVA|F(2,107)=3.440, partial n2=0.060, observed power=0.634||ANCOVA - Group Comparison of Socio-Emotional Growth Subscale scores at 8 months, controlling for scores at baseline (4 months). Group entered as fixed factor, outcome scores as dependent variable, and baseline scores as covariate.||||0.036
72390074|NCT01056653|144288108|SUPERIORITY_OR_OTHER|||||||0.036||||||Bonferroni adjustments for multiple comparisons used|ANCOVA|||Pairwise Group Comparison based on estimated marginal means - Socio-Emotional Growth Fostering Subscale||||0.036
72390075|NCT01056653|144288108|SUPERIORITY_OR_OTHER|||||||1||||||Bonferroni adjustments for multiple comparisons used|ANCOVA|||Pairwise Group Comparison based on estimated marginal means - Socio-Emotional Growth Fostering Subscale||||1.00
72390076|NCT01056653|144288108|SUPERIORITY_OR_OTHER|||||||0.665|||||||ANCOVA|F(2,107)=0.409||ANCOVA - Group Comparison of Sensitivity to Cues Subscale scores at 8 months, controlling for scores at baseline (4 months). Group entered as fixed factor, outcome scores as dependent variable, and baseline scores as covariate.||||0.665
72390077|NCT01056653|144288108|SUPERIORITY_OR_OTHER|||||||0.732|||||||ANCOVA|F(2,107)=0.313||ANCOVA - Group Comparison of Response to Distress Subscale scores at 8 months, controlling for scores at baseline (4 months). Group entered as fixed factor, outcome scores as dependent variable, and baseline scores as covariate.||||0.732
72390078|NCT01056653|144288109|SUPERIORITY_OR_OTHER|||||||0.61|||||||ANCOVA|F(2,107)=0.49||ANCOVA - Group Comparison of Parent Domain scores at 8 months, controlling for scores at baseline (4 months). Group entered as fixed factor, outcome scores as dependent variable, and baseline scores as covariate.||||0.61
72390079|NCT01056653|144288109|SUPERIORITY_OR_OTHER|||||||0.38|||||||ANCOVA|F(2,107)=0.96||ANCOVA - Group Comparison of Child Domain scores at 8 months, controlling for scores at baseline (4 months). Group entered as fixed factor, outcome scores as dependent variable, and baseline scores as covariate.||||0.38
72390080|NCT01056653|144288110|SUPERIORITY_OR_OTHER|||||||0.11|||||||ANCOVA|F(2,106)=2.24.||ANCOVA - Group Comparison of WPL-R scores - Evaluation Subscale scores at 8 months, controlling for scores at baseline (4 months). Group entered as fixed factor, outcome scores as dependent variable, and baseline scores as covariate.||||0.11
72390081|NCT01056653|144288110|SUPERIORITY_OR_OTHER|||||||0.686|||||||ANCOVA|F(2,106)=0.379||ANCOVA - Group Comparison of WPL-R scores - Centrality Subscale scores at 8 months, controlling for scores at baseline (4 months). Group entered as fixed factor, outcome scores as dependent variable, and baseline scores as covariate.||||0.686
72390082|NCT01056653|144288110|SUPERIORITY_OR_OTHER|||||||0.121|||||||ANCOVA|F(2,106)=2.158||ANCOVA - Group Comparison of WPL-R scores - Life Change Subscale scores at 8 months, controlling for scores at baseline (4 months). Group entered as fixed factor, outcome scores as dependent variable, and baseline scores as covariate.||||0.121
72390083|NCT03727230|144288120|OTHER||||||<|0.001|||||||Chi-squared|||In this study, a single-arm clinical trial was conducted. The summarized alloanti-D rate (203/720, 28.2%; 95% CI, 19%-32%) in truly RhD-negative patients with similar mixed diseases after RhD+ RBC transfusion reported in the meta-analysis (Ji YL, et al. Vox Sang 2022; 117: 633-40) was used as the control for comparison with alloanti-D rate identified in Asian-type DEL patients after RhD+ RBC transfusion in the clinical trial.||||< 0.001
72390084|NCT04377620|144288132|SUPERIORITY||Odds Ratio (OR)|0.46||||0.0292|TWO_SIDED|95.0|0.201|1.028|||Mixed Models Analysis|logistic regression mixed model includes treatment group and ARDS severity as fixed covariates and investigational site as a random effect.||||1.028|0.201|0.0292
72390085|NCT04377620|144288132|SUPERIORITY||Odds Ratio (OR)|0.42||||0.028|TWO_SIDED|95.0|0.171|1.023|||Mixed Models Analysis|logistic regression mixed model includes treatment group and ARDS severity as fixed covariates and investigational site as a random effect.||||1.023|0.171|0.0280
72390086|NCT03768414|144288145|SUPERIORITY||Hazard Ratio (HR)|0.91||||0.41|TWO_SIDED|95.0|0.72|1.14|||Log Rank|||||1.14|0.72|0.41
72390087|NCT03851705|144288151|SUPERIORITY||Mean Difference (Final Values)|-1.68||||0.9047|TWO_SIDED|95.0|-29.19|25.83||The a priori threshold for statistical significance was \<0.05 (two-sided)|ANCOVA|||||25.83|-29.19|0.9047
72390088|NCT03851705|144288152|SUPERIORITY||Mean Difference (Final Values)|6.47||||0.8685|TWO_SIDED|95.0|-70.11|83.05||The a priori threshold for statistical significance was \<0.05 (two-sided)|ANCOVA|||||83.05|-70.11|0.8685
72561093|NCT03702816|144652724|OTHER|Linear Regression||||||0.25|||||||Regression, Linear|F=1.779||Linear Regression of Memory Composite Scores and Temporal GE180 SUVR in MCI Subjects||||0.25
72561094|NCT03702816|144652724|OTHER|Linear Regression||||||0.54|||||||Regression, Linear|F=0.455||Linear Regression of Executive Function Composite Scores and Temporal GE180 SUVR in MCI Subjects||||0.54
72561095|NCT03702816|144652724|OTHER|Linear Regression||||||0.47|||||||Regression, Linear|F=0.650||Linear Regression of Speed Composite Scores and Temporal GE180 SUVR in MCI Subjects||||0.47
72561096|NCT03702816|144652724|OTHER|Linear Regression||||||0.74|||||||Regression, Linear|F=0.131||Linear Regression of Language Composite Scores and Temporal GE180 SUVR in MCI Subjects||||0.74
72497972|NCT02928952|144526292|SUPERIORITY|Statistical Test of hypothesis. Analyzed as intention to treat in mixed models with imputation as last value moved forward.||||||0.632|||||||Mixed Models Analysis|All models adjusted for age and duration of diabetes.||The statistical analysis was applied to both groups.||||0.632
72497973|NCT02928952|144526293|SUPERIORITY|Statistical Test of hypothesis. Analyzed as intention to treat in mixed models with imputation as last value moved forward.||||||0.219|||||||Mixed Models Analysis|All models were adjusted for age and duration of diabetes.||The statistical analysis was applied to both groups.||||0.219
72561097|NCT03702816|144652724|OTHER|Linear Regression||||||0.83|||||||Regression, Linear|F=0.075||Linear Regression of Memory Composite Scores and Temporal GE180 SUVR in AD Subjects||||0.83
72561098|NCT03702816|144652724|OTHER|Linear Regression||||||0.41|||||||Regression, Linear|F=1.831||Linear Regression of Executive Function Composite Scores and Temporal GE180 SUVR in AD Subjects||||0.41
72561099|NCT03702816|144652724|OTHER|Linear Regression||||||0.83|||||||Regression, Linear|F=0.079||Linear Regression of Speed Composite Scores and Temporal GE180 SUVR in AD Subjects||||0.83
72561100|NCT03702816|144652724|OTHER|Linear Regression||||||0.52|||||||Regression, Linear|F=0.879||Linear Regression of Language Composite Scores and Temporal GE180 SUVR in AD Subjects||||0.52
72561101|NCT03702816|144652724|OTHER|Linear Regression||||||0.98|||||||Regression, Linear|F=0.001||Linear Regression of Memory Composite Scores and Temporal GE180 SUVR in PD Subjects||||0.98
72390089|NCT03851705|144288153|SUPERIORITY||Mean Difference (Final Values)|-12.1||||0.2347|TWO_SIDED|95.0|-32.2|8.1||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 90||8.1|-32.2|0.2347
72390090|NCT03851705|144288153|SUPERIORITY||Mean Difference (Final Values)|4.6||||0.7058|TWO_SIDED|95.0|-19.9|29.2||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 150||29.2|-19.9|0.7058
72390091|NCT03851705|144288153|SUPERIORITY||Mean Difference (Final Values)|-5.7||||0.5653|TWO_SIDED|95.0|-25.5|14.1||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 180||14.1|-25.5|0.5653
72390092|NCT03851705|144288155|SUPERIORITY||Mean Difference (Final Values)|-19.9||||0.4589|TWO_SIDED|95.0|-73.3|33.6||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 90||33.6|-73.3|0.4589
72390093|NCT03851705|144288155|SUPERIORITY||Mean Difference (Final Values)|17.7||||0.5956|TWO_SIDED|95.0|-48.8|84.3||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 150||84.3|-48.8|0.5956
72390094|NCT03851705|144288155|SUPERIORITY||Mean Difference (Final Values)|-7.5||||0.7861|TWO_SIDED|95.0|-62.7|47.7||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 180||47.7|-62.7|0.7861
72390095|NCT03851705|144288157|SUPERIORITY||Mean Difference (Final Values)|-62.6|||<|0.0001|TWO_SIDED|95.0|-80.1|-45.1||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 90||-45.1|-80.1|<.0001
72390096|NCT03851705|144288157|SUPERIORITY||Mean Difference (Final Values)|-60.6|||<|0.0001|TWO_SIDED|95.0|-83.5|-37.8||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 150||-37.8|-83.5|<.0001
72390097|NCT03851705|144288157|SUPERIORITY||Mean Difference (Final Values)|-92.3|||<|0.0001|TWO_SIDED|95.0|-120.4|-64.2||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 150||-64.2|-120.4|<.0001
72390098|NCT03851705|144288159|SUPERIORITY||Mean Difference (Final Values)|-316.6|||<|0.0001|TWO_SIDED|95.0|-420.7|-212.6||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 90||-212.6|-420.7|<.0001
72390099|NCT03851705|144288159|SUPERIORITY||Mean Difference (Final Values)|-304.4|||<|0.0001|TWO_SIDED|95.0|-408.0|-200.8||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 150||-200.8|-408.0|<.0001
72390100|NCT03851705|144288159|SUPERIORITY||Mean Difference (Final Values)|-390.4|||<|0.0001|TWO_SIDED|95.0|-504.5|-276.3||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 180||-276.3|-504.5|<.0001
72390101|NCT03851705|144288161|SUPERIORITY||Mean Difference (Final Values)|-7.9||||0.3299|TWO_SIDED|95.0|-23.9|8.2||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 90||8.2|-23.9|0.3299
72390102|NCT03851705|144288161|SUPERIORITY||Mean Difference (Final Values)|2.7||||0.7778|TWO_SIDED|95.0|-16.7|22.2||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 150||22.2|-16.7|0.7778
72390103|NCT03851705|144288161|SUPERIORITY||Mean Difference (Final Values)|-3.5||||0.6613|TWO_SIDED|95.0|-19.2|12.3||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 180||12.3|-19.2|0.6613
72390104|NCT03851705|144288162|SUPERIORITY||Mean Difference (Final Values)|-19.0||||0.4911|TWO_SIDED|95.0|-74.0|36.0||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 90||36.0|-74.0|0.4911
72390105|NCT03851705|144288162|SUPERIORITY||Mean Difference (Final Values)|11.1||||0.7461|TWO_SIDED|95.0|-57.2|79.4||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 150||79.4|-57.2|0.7461
72390106|NCT03851705|144288162|SUPERIORITY||Mean Difference (Final Values)|-5.9||||0.837|TWO_SIDED|95.0|-62.8|51.1||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 180||51.1|-62.8|0.8370
72390107|NCT03851705|144288165|SUPERIORITY||Mean Difference (Final Values)|-12.7||||0.1371|TWO_SIDED|95.0|-29.5|4.2||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 90||4.2|-29.5|0.1371
72390108|NCT03851705|144288165|SUPERIORITY||Mean Difference (Final Values)|-3.5||||0.71|TWO_SIDED|95.0|-22.6|15.5||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 150||15.5|-22.6|0.7100
72390109|NCT03851705|144288165|SUPERIORITY||Mean Difference (Final Values)|-10.3||||0.2278|TWO_SIDED|95.0|-27.2|6.6||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 180||6.6|-27.2|0.2278
72390110|NCT03851705|144288167|SUPERIORITY||Mean Difference (Final Values)|-19.4||||0.2044|TWO_SIDED|95.0|-49.7|10.9||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 90||10.9|-49.7|0.2044
72561102|NCT03702816|144652724|OTHER|Linear Regression||||||0.95|||||||Regression, Linear|F=0.005||Linear Regression of Executive Function Composite Scores and Temporal GE180 SUVR in PD Subjects||||0.95
72561103|NCT03702816|144652724|OTHER|Linear Regression||||||0.32|||||||Regression, Linear|F=1.733||Linear Regression of Speed Composite Scores and Temporal GE180 SUVR in PD Subjects||||0.32
72561104|NCT03702816|144652724|OTHER|Linear Regression||||||0.67|||||||Regression, Linear|F=0.249||Linear Regression of Language Composite Scores and Temporal GE180 SUVR in PD Subjects||||0.67
72619362|NCT04535362|144769404|SUPERIORITY||Mean Difference (Net)|0.46|STANDARD_ERROR_OF_MEAN|0.51||0.37|TWO_SIDED||||||Mixed Models Analysis|||The fixed effects in the mixed models were infusion rate (2.5 minutes, 5 minutes and 10 minutes (placebo)), cigarette condition (menthol vs. non-menthol), and their interaction. We also controlled for order effects of cigarette condition by including session in the models Subject was a clustering factor and different variance-covariance structures were considered within each condition and subject. The best-fitting structure was selected based on Schwartz's Bayesian Criterion.||||0.37
72390111|NCT03851705|144288167|SUPERIORITY||Mean Difference (Final Values)|-4.8||||0.7875|TWO_SIDED|95.0|-39.9|30.4||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 150||30.4|-39.9|0.7875
72446622|NCT05235750|144409444|OTHER||Mean Difference (Net)|-2.1||||0.19|TWO_SIDED|||||The above p value refers to the difference between 2 weeks post-intervention change and pre-intervention change (or \[(T4-T2)-(T2-T1)\]) for the total FACIT-Sp-12.|Mixed Models Analysis||The above value represents net difference between 2 weeks post-intervention change and pre-intervention change (or \[(T4-T2)-(T2-T1)\]) for the total FACIT-Sp-12.|||||.19
72497974|NCT02928952|144526294|SUPERIORITY|Statistical Test of hypothesis. Analyzed as intention to treat in mixed models with imputation as last value moved forward.||||||0.931|||||||Mixed Models Analysis|All models were adjusted for age and duration of diabetes.||The statistical analysis was applied to both groups.||||0.931
72561105|NCT03702816|144652725|OTHER|Linear Regression||||||0.76|||||||Regression, Linear|F=0.098||Linear Regression of DRS Scores and Whole Brain GE180 SUVR in Control Subjects||||0.76
72561106|NCT03702816|144652725|OTHER|Linear Regression||||||0.49|||||||Regression, Linear|F=0.513||Linear Regression of MoCA Scores and Whole Brain GE180 SUVR in Control Subjects||||0.49
72561107|NCT03702816|144652725|OTHER|Linear Regression||||||0.93|||||||Regression, Linear|F=0.008||Linear Regression of DRS Scores and Whole Brain GE180 SUVR in MCI Subjects||||0.93
72561108|NCT03702816|144652725|OTHER|Linear Regression||||||0.54|||||||Regression, Linear|F=0.430||Linear Regression of MoCA Scores and Whole Brain GE180 SUVR in MCI Subjects||||0.54
72561109|NCT03702816|144652725|OTHER|Linear Regression||||||0.77|||||||Regression, Linear|F=0.142||Linear Regression of DRS Scores and Whole Brain GE180 SUVR in AD Subjects||||0.77
72561110|NCT03702816|144652725|OTHER|Linear Regression||||||0.61|||||||Regression, Linear|F=0.496||Linear Regression of MoCA Scores and Whole Brain GE180 SUVR in AD Subjects||||0.61
72390112|NCT03851705|144288167|SUPERIORITY||Mean Difference (Final Values)|-15.8||||0.3193|TWO_SIDED|95.0|-47.3|15.7||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 180||15.7|-47.3|0.3193
72390113|NCT03851705|144288169|SUPERIORITY||Mean Difference (Final Values)|-10.1||||0.2877|TWO_SIDED|95.0|-29.0|8.8||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 90||8.8|-29.0|0.2877
72390114|NCT03851705|144288169|SUPERIORITY||Mean Difference (Final Values)|3.0||||0.7944|TWO_SIDED|95.0|-19.7|25.7||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 150||25.7|-19.7|0.7944
72390115|NCT03851705|144288169|SUPERIORITY||Mean Difference (Final Values)|-5.1||||0.5803|TWO_SIDED|95.0|-23.4|13.3||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 180||13.3|-23.4|0.5803
72390116|NCT03851705|144288171|SUPERIORITY||Mean Difference (Final Values)|-19.1||||0.4848|TWO_SIDED|95.0|-73.6|35.3||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 90||35.3|-73.6|0.4848
72390117|NCT03851705|144288171|SUPERIORITY||Mean Difference (Final Values)|12.2||||0.722|TWO_SIDED|95.0|-56.0|80.3||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 150||80.3|-56.0|0.7220
72390118|NCT03851705|144288171|SUPERIORITY||Mean Difference (Final Values)|-7.0||||0.8036|TWO_SIDED|95.0|-63.6|49.5||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 180||49.5|-63.6|0.8036
72390119|NCT03851705|144288179|SUPERIORITY||Mean Difference (Final Values)|2.4||||0.6028|TWO_SIDED|95.0|-6.8|11.7||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 90||11.7|-6.8|0.6028
72390120|NCT03851705|144288179|SUPERIORITY||Mean Difference (Final Values)|1.3||||0.8428|TWO_SIDED|95.0|-11.5|14.0||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 150||14.0|-11.5|0.8428
72390121|NCT03851705|144288179|SUPERIORITY||Mean Difference (Final Values)|3.4||||0.4946|TWO_SIDED|95.0|-6.6|13.4||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 180||13.4|-6.6|0.4946
72390122|NCT03851705|144288181|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.9237|TWO_SIDED|95.0|-4.0|4.4||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 90||4.4|-4.0|0.9237
72390123|NCT03851705|144288181|SUPERIORITY||Mean Difference (Final Values)|-1.0||||0.7177|TWO_SIDED|95.0|-6.5|4.5||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 150||4.5|-6.5|0.7177
72390124|NCT03851705|144288181|SUPERIORITY||Mean Difference (Final Values)|1.3||||0.5416|TWO_SIDED|95.0|-2.9|5.4||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 180||5.4|-2.9|0.5416
72390125|NCT03851705|144288183|SUPERIORITY||Mean Difference (Final Values)|1.0||||0.6497|TWO_SIDED|95.0|-3.2|5.2||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 90||5.2|-3.2|0.6497
72390126|NCT03851705|144288183|SUPERIORITY||Mean Difference (Final Values)|-2.6||||0.3209|TWO_SIDED|95.0|-7.9|2.6||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 150||2.6|-7.9|0.3209
72497975|NCT02928952|144526295|SUPERIORITY|Statistical Test of hypothesis. Analyzed as intention to treat in mixed models with imputation as last value moved forward.||||||0.627|||||||Mixed Models Analysis|All models were adjusted for age and duration of diabetes.||The statistical analysis was applied to both groups.||||0.627
72561111|NCT03702816|144652725|OTHER|Linear Regression||||||0.11|||||||Regression, Linear|F=8.046||Linear Regression of DRS Scores and Whole Brain GE180 SUVR in PD Subjects||||0.11
72561112|NCT03702816|144652725|OTHER|Linear Regression||||||0.84|||||||Regression, Linear|F=0.051||Linear Regression of MoCA Scores and Whole Brain GE180 SUVR in PD Subjects||||0.84
72390127|NCT03851705|144288183|SUPERIORITY||Mean Difference (Final Values)|-0.3||||0.9294|TWO_SIDED|95.0|-6.3|5.7||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 180||5.7|-6.3|0.9294
72497976|NCT02928952|144526296|SUPERIORITY|Statistical Test of hypothesis. Analyzed as intention to treat in mixed models with imputation as last value moved forward.||||||0.6|||||||Mixed Models Analysis|All models were adjusted for age and duration of diabetes.||The statistical analysis was applied to both groups.||||0.60
72561113|NCT03298880|144652807|SUPERIORITY||Mean Difference (Net)|3.7|STANDARD_ERROR_OF_MEAN|1.12|<|0.001|TWO_SIDED|95.0|2.1|5.3|||mixed linear regression|||||5.3|2.1|<0.001
72561114|NCT03298880|144652807|SUPERIORITY||Mean Difference (Net)|2.3||||0.003|TWO_SIDED|95.0|0.8|3.8|||mixed linear regression|||||3.8|0.8|0.003
72561115|NCT04640194|144652819|OTHER||Hazard Ratio (HR)|1.01|||||TWO_SIDED|95.0|0.39|2.61|||||A hazard ratio \> 1 favours the alteplase dose group over standard of care alone.|Unadjusted Hazard Ratio: Cox proportional hazard model containing fixed effect for treatment. The confidence intervals was determined using the Wald method to determine the variance.||2.61|0.39|
72561116|NCT04640194|144652819|OTHER||Hazard Ratio (HR)|1.23|||||TWO_SIDED|95.0|0.46|3.27|||||A hazard ratio \> 1 favours the alteplase dose group over standard of care alone.|Adjusted Hazard Ratio: Cox proportional hazard model containing fixed effect for treatment,ventilation status at baseline and age. The confidence intervals was determined using the Wald method to determine the variance.||3.27|0.46|
72561117|NCT04640194|144652819|OTHER||Hazard Ratio (HR)|1.75|||||TWO_SIDED|95.0|0.73|4.15|||||A hazard ratio \> 1 favours the alteplase dose group over standard of care alone.|Unadjusted Hazard Ratio: Cox proportional hazard model containing fixed effect for treatment. The confidence intervals was determined using the Wald method to determine the variance.||4.15|0.73|
72561118|NCT04640194|144652819|OTHER||Hazard Ratio (HR)|2.04|||||TWO_SIDED|95.0|0.83|5.01|||||A hazard ratio \> 1 favours the alteplase dose group over standard of care alone.|Adjusted Hazard Ratio: Cox proportional hazard model containing fixed effect for treatment,ventilation status at baseline and age. The confidence intervals was determined using the Wald method to determine the variance.||5.01|0.83|
72561119|NCT04640194|144652819|OTHER||Hazard Ratio (HR)|1.13|||||TWO_SIDED|95.0|0.35|3.66|||||A hazard ratio \> 1 favours the alteplase dose group over standard of care alone.|Unadjusted Hazard Ratio: Cox proportional hazard model containing fixed effect for treatment. The confidence intervals was determined using the Wald method to determine the variance.||3.66|0.35|
72561120|NCT04640194|144652819|OTHER||Hazard Ratio (HR)|1.19|||||TWO_SIDED|95.0|0.33|4.22|||||A hazard ratio \> 1 favours the alteplase dose group over standard of care alone.|Adjusted Hazard Ratio: Cox proportional hazard model containing fixed effect for treatment,ventilation status at baseline and age. The confidence intervals was determined using the Wald method to determine the variance.||4.22|0.33|
72561121|NCT04640194|144652820|OTHER||Risk Difference (RD)|5.0|||||TWO_SIDED|95.0|-10.892|24.8734|||||Chan and Zhang exact confidence interval.|||24.8734|-10.892|
72561122|NCT04640194|144652820|OTHER||Risk Difference (RD)|20.0|||||TWO_SIDED|95.0|2.3075|43.6615|||||Chan and Zhang exact confidence interval.|||43.6615|2.3075|
72561123|NCT04640194|144652820|OTHER||Risk Difference (RD)|11.76|||||TWO_SIDED|95.0|-24.127|36.9012|||||Chan and Zhang exact confidence interval.|||36.9012|-24.127|
72561124|NCT04640194|144652821|OTHER||Risk Difference (RD)|-16.6|||||TWO_SIDED|95.0|-38.6|5.5|||||Calculated as alteplase dose group - standard of care alone.|Adjusted risk difference and 95% confidence interval is based upon average marginal effect Delta method, adjusting for baseline ventilation status, age and treatment.||5.5|-38.6|
72561125|NCT04640194|144652821|OTHER||Risk Difference (RD)|-11.8|||||TWO_SIDED|95.0|-35.1|11.6|||||Calculated as alteplase dose group - standard of care alone.|Adjusted risk difference and 95% confidence interval is based upon average marginal effect Delta method, adjusting for baseline ventilation status, age and treatment.||11.6|-35.1|
72561126|NCT04640194|144652821|OTHER||Risk Difference (RD)|-19.1||||0.2419|TWO_SIDED|95.0|-51.1|12.9|||The delta method and average marginal.||Calculated as alteplase dose group - standard of care alone.|Unadjusted risk difference and 95% CI is based upon average marginal effect Delta method, adjusting for treatment.||12.9|-51.1|0.2419
72561127|NCT04640194|144652822|OTHER||Risk Difference (RD)|-9.0|||||TWO_SIDED|95.0|-37.1|19.1|||||Calculated as alteplase dose group - standard of care alone.|Adjusted risk difference and 95% confidence interval is based upon average marginal effect Delta method, adjusting for baseline ventilation status, age and treatment.||19.1|-37.1|
72561128|NCT04640194|144652822|OTHER||Risk Difference (RD)|-9.1|||||TWO_SIDED|95.0|-37.2|19.0|||||Calculated as alteplase dose group - standard of care alone.|Adjusted risk difference and 95% confidence interval is based upon average marginal effect Delta method, adjusting for baseline ventilation status, age and treatment.||19.0|-37.2|
72561129|NCT04640194|144652822|OTHER||Risk Difference (RD)|14.5||||0.2523|TWO_SIDED|95.0|-10.3|39.3|||The delta method and average marginal.||Calculated as alteplase dose group - standard of care alone.|Adjusted risk difference and 95% CI is based upon average marginal effect Delta method, adjusting for baseline D-dimer status, age, days of NIV support and treatment.||39.3|-10.3|0.2523
72561130|NCT04640194|144652823|OTHER||Mean Difference (Final Values)|3.1|STANDARD_ERROR_OF_MEAN|3.7|||TWO_SIDED|95.0|-4.4|10.6|||||Calculated as alteplase dose group - standard of care alone.|Parameters included in model: treatment,ventilation status at baseline, and age.||10.6|-4.4|
72561131|NCT04640194|144652823|OTHER||Median Difference (Final Values)|4.3|STANDARD_ERROR_OF_MEAN|3.7|||TWO_SIDED|95.0|-3.2|11.8|||||Calculated as alteplase dose group - standard of care alone.|Parameters included in model: treatment,ventilation status at baseline, and age.||11.8|-3.2|
72497977|NCT02928952|144526297|SUPERIORITY|Statistical Test of hypothesis. Analyzed as intention to treat in mixed models with imputation as last value moved forward.||||||0.461|||||||Mixed Models Analysis|All models were adjusted for age and duration of diabetes.||The statistical analysis was applied to both groups.||||0.461
72561132|NCT04640194|144652824|OTHER||Risk Difference (RD)|-4.9|||||TWO_SIDED|95.0|-29.0|19.2|||||Calculated as alteplase dose group - standard of care alone.|Adjusted risk difference and 95% confidence interval is based upon average marginal effect Delta method, adjusting for baseline ventilation status, age and treatment.||19.2|-29.0|
72390128|NCT03851705|144288185|SUPERIORITY||Mean Difference (Final Values)|11.3||||0.3105|TWO_SIDED|95.0|-10.8|33.4||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 90||33.4|-10.8|0.3105
72390129|NCT03851705|144288185|SUPERIORITY||Mean Difference (Final Values)|-11.4||||0.3018|TWO_SIDED|95.0|-33.3|10.5||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 150||10.5|-33.3|0.3018
72390130|NCT03851705|144288185|SUPERIORITY||Mean Difference (Final Values)|2.3||||0.8755|TWO_SIDED|95.0|-27.0|31.6||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 180||31.6|-27.0|0.8755
72390131|NCT03851705|144288187|SUPERIORITY||Mean Difference (Final Values)|-1.9||||0.6848|TWO_SIDED|95.0|-11.5|7.6||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 90||7.6|-11.5|0.6848
72390132|NCT03851705|144288187|SUPERIORITY||Mean Difference (Final Values)|-5.4||||0.4075|TWO_SIDED|95.0|-18.5|7.6||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 150||7.6|-18.5|0.4075
72390133|NCT03851705|144288187|SUPERIORITY||Mean Difference (Final Values)|-2.8||||0.5998|TWO_SIDED|95.0|-13.4|7.8||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 180||7.8|-13.4|0.5998
72390134|NCT03851705|144288189|SUPERIORITY||Mean Difference (Final Values)|-1.0||||0.7958|TWO_SIDED|95.0|-8.4|6.5||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 90||6.5|-8.4|0.7958
72390135|NCT03851705|144288189|SUPERIORITY||Mean Difference (Final Values)|-2.6||||0.6003|TWO_SIDED|95.0|-12.7|7.4||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 150||7.4|-12.7|0.6003
72390136|NCT03851705|144288189|SUPERIORITY||Mean Difference (Final Values)|-2.6||||0.5352|TWO_SIDED|95.0|-11.0|5.8||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 180||5.8|-11.0|0.5352
72390137|NCT03851705|144288191|SUPERIORITY||Mean Difference (Final Values)|-8.9||||0.1716|TWO_SIDED|95.0|-21.8|4.0||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 90||4.0|-21.8|0.1716
72390138|NCT03851705|144288191|SUPERIORITY||Mean Difference (Final Values)|-19.0||||0.1671|TWO_SIDED|95.0|-46.2|8.2||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 150||8.2|-46.2|0.1671
72390139|NCT03851705|144288191|SUPERIORITY||Mean Difference (Final Values)|-9.7||||0.1808|TWO_SIDED|95.0|-24.2|4.7||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 180||4.7|-24.2|0.1808
72390140|NCT03851705|144288193|SUPERIORITY||Mean Difference (Final Values)|-9.6||||0.3077|TWO_SIDED|95.0|-28.3|9.1||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 90||9.1|-28.3|0.3077
72390141|NCT03851705|144288193|SUPERIORITY||Mean Difference (Final Values)|-9.4||||0.3628|TWO_SIDED|95.0|-30.1|11.2||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 150||11.2|-30.1|0.3628
72390142|NCT03851705|144288193|SUPERIORITY||Mean Difference (Final Values)|-6.2||||0.4669|TWO_SIDED|95.0|-23.2|10.8||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 180||10.8|-23.2|0.4669
72390143|NCT03851705|144288199|SUPERIORITY||Mean Difference (Final Values)|-4.31||||0.6814|TWO_SIDED|95.0|-24.88|16.27|||ANCOVA|||||16.27|-24.88|0.6814
72390144|NCT03851705|144288200|SUPERIORITY||Mean Difference (Final Values)|-2.1||||0.8725|TWO_SIDED|95.0|-27.7|23.51|||ANCOVA|||||23.51|-27.70|0.8725
72390145|NCT03851705|144288201|SUPERIORITY||Mean Difference (Final Values)|-0.79||||0.9425|TWO_SIDED|95.0|-22.3|20.72|||ANCOVA|||||20.72|-22.30|0.9425
72390146|NCT03851705|144288202|SUPERIORITY||Odds Ratio (OR)|1.1|||||TWO_SIDED|95.0|0.2|5.2|||Regression, Logistic|||||5.2|0.2|
72390147|NCT00692341|144288203|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|88.61|||||TWO_SIDED|90.0|49.2|159.56||||||For mild hepatic impairment, analysis of variance (ANOVA) was used to compare natural log transformed Cmax of axitinib (AG-013736) between the control group (normal hepatic function) and mild hepatic impairment. The point estimates and confidence intervals (CIs) on the log-scale were back transformed to provide estimates of the ratio of adjusted geometric means (mild hepatic impairment/normal hepatic function) and 90% CIs for the ratios.||159.56|49.20|
72390148|NCT00692341|144288203|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|127.67|||||TWO_SIDED|90.0|70.9|229.91||||||For moderate hepatic impairment, ANOVA was used to compare natural log transformed Cmax of axitinib (AG-013736) between the control group (normal hepatic function) and moderate hepatic impairment. The point estimates and CIs on the log-scale were back transformed to provide estimates of the ratio of adjusted geometric means (moderate hepatic impairment/normal hepatic function) and 90% CIs for the ratios.||229.91|70.90|
72390149|NCT00692341|144288204|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|78.34|||||TWO_SIDED|90.0|39.92|153.75||||||For mild hepatic impairment, ANOVA was used to compare natural log transformed AUC (0 - ∞) of axitinib (AG-013736) between the control group (normal hepatic function) and mild hepatic impairment. The point estimates and CIs on the log-scale were back transformed to provide estimates of the ratio of adjusted geometric means (mild hepatic impairment/normal hepatic function) and 90% CIs for the ratios.||153.75|39.92|
72497978|NCT02928952|144526298|SUPERIORITY|Statistical Test of hypothesis. Analyzed as intention to treat in mixed models with imputation as last value moved forward.||||||0.906|||||||Mixed Models Analysis|All models were adjusted for age and duration of diabetes.||The statistical analysis was applied to both groups.||||0.906
72561133|NCT04640194|144652824|OTHER||Risk Difference (RD)|-15.2|||||TWO_SIDED|95.0|-36.8|6.3|||||Calculated as alteplase dose group - standard of care alone.|Adjusted risk difference and 95% confidence interval is based upon average marginal effect Delta method, adjusting for baseline ventilation status, age and treatment.||6.3|-36.8|
72561134|NCT04640194|144652825|OTHER||Median Difference (Net)|17.193|||||TWO_SIDED|95.0|-28.45|52.33|||||Calculated as alteplase dose group - standard of care alone.|Based upon Hedges-Lehmann estimator handling deaths as failure and Wilcoxon rank sum test methodology.||52.33|-28.45|
72446623|NCT05235750|144409444|OTHER||Mean Difference (Net)|-1.0||||0.35|TWO_SIDED|||||The above p value refers to the difference between post-intervention change and pre-intervention change (or \[(T3-T2)-(T2-T1)\]) for the Meaning/Peace factor (M/P) as measured by the FACIT-Sp-12.|Mixed Models Analysis||The above value represents net difference between post-intervention change and pre-intervention change (or \[(T3-T2)-(T2-T1)\]) for the Meaning/Peace factor (M/P) as measured by the FACIT-Sp-12.|||||.35
72446624|NCT05235750|144409444|OTHER||Mean Difference (Net)|-1.9||||0.99|TWO_SIDED|||||The above p value refers to the difference between 2 weeks post-intervention change and pre-intervention change (or \[(T4-T2)-(T2-T1)\]) for the Meaning/Peace factor (M/P) as measured by the FACIT-Sp-12.|Mixed Models Analysis||The above value represents net difference between 2 weeks post-intervention change and pre-intervention change (or \[(T4-T2)-(T2-T1)\]) for the Meaning/Peace factor (M/P) as measured by the FACIT-Sp-12.|||||.99
72446625|NCT05235750|144409444|OTHER||Mean Difference (Net)|0.4||||0.46|TWO_SIDED|||||The above p value refers to the difference between post-intervention change and pre-intervention change (or \[(T3-T2)-(T2-T1)\]) for the Faith factor of the FACIT-Sp-12.|Mixed Models Analysis||The above value represents net difference between post-intervention change and pre-intervention change (or \[(T3-T2)-(T2-T1)\]) for the Faith factor of the FACIT-Sp-12.|||||.46
72446626|NCT05235750|144409444|OTHER||Mean Difference (Net)|-0.7||||0.24|TWO_SIDED|||||The above p value refers to the difference between 2 weeks post-intervention change and pre-intervention change (or \[(T4-T2)-(T2-T1)\]) for the Faith factor of the FACIT-Sp-12.|Mixed Models Analysis||The above value represents net difference between 2 weeks post-intervention change and pre-intervention change (or \[(T4-T2)-(T2-T1)\]) for the Faith factor of the FACIT-Sp-12.|||||.24
72497979|NCT02928952|144526299|SUPERIORITY|Statistical Test of hypothesis. Analyzed as intention to treat in mixed models with imputation as last value moved forward.||||||0.856|||||||Mixed Models Analysis|All models were adjusted for age and duration of diabetes.||The statistical analysis was applied to both groups.||||0.856
72497980|NCT02928952|144526300|SUPERIORITY|Statistical Test of hypothesis. Analyzed as intention to treat in mixed models with imputation as last value moved forward.||||||0.89|||||||Mixed Models Analysis|All models adjusted for age and duration of diabetes.||The statistical analysis was applied to both groups.||||0.89
72497981|NCT01850615|144526301|SUPERIORITY_OR_OTHER||Treatment difference|-0.94|||||TWO_SIDED|95.0|-1.17|-0.72|||||Superiority was considered confirmed if the upper bound of the two-sided 95% confidence interval (CI) for the estimated treatment difference (faster aspart+basal minus basal only), which was calculated using the FAS, was below 0%.|Change from baseline in HbA1c after 18 weeks of treatment was analysed using a mixed-effect model for repeated measurements (MMRM) where all calculated changes in HbA1c from baseline at visits 16, 22 and 28 were included in the analysis. This model included treatment, region and strata as fixed factors, subject as random effect, baseline HbA1c as covariate and interaction between all fixed effects and visit, and between the covariate and visit.||-0.72|-1.17|
72497982|NCT01375764|144526393|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-35.94|STANDARD_ERROR_OF_MEAN|4.11|<|0.001|TWO_SIDED|95.0|-44.08|-27.8||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|ANCOVA|The ANCOVA model included treatment group (3 evolocumab alone dose groups and the ezetimibe group) and the stratification factors.|Ezetimibe is the reference.|The null hypothesis was that there was no mean difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and ezetimibe, and the alternative hypothesis was that a mean difference did exist.||-27.80|-44.08|<0.001
72561135|NCT04640194|144652825|OTHER||Median Difference (Final Values)|54.436|||||TWO_SIDED|95.0|0.49|110.36|||||Calculated as alteplase dose group - standard of care alone.|Based upon Hedges-Lehmann estimator handling deaths as failure and Wilcoxon rank sum test methodology.||110.36|0.49|
72446627|NCT05235750|144409444|OTHER||Mean Difference (Net)|-0.4||||0.55|TWO_SIDED|||||The above p value refers to the difference between post-intervention change and pre-intervention change (or \[(T3-T2)-(T2-T1)\]) for the revised Faith factor of the FACIT-Sp-12.|Mixed Models Analysis||The above value represents net difference between post-intervention change and pre-intervention change (or \[(T3-T2)-(T2-T1)\]) for the revised Faith factor of the FACIT-Sp-12.|||||.55
72446628|NCT05235750|144409444|OTHER||Mean Difference (Net)|-0.9||||0.8|TWO_SIDED|||||The above p value refers to the difference between 2 weeks post-intervention change and pre-intervention change (or \[(T4-T2)-(T2-T1)\]) for the revised Faith factor of the FACIT-Sp-12.|Mixed Models Analysis||The above value represents net difference between 2 weeks post-intervention change and pre-intervention change (or \[(T4-T2)-(T2-T1)\]) for the revised Faith factor of the FACIT-Sp-12.|||||.80
72497983|NCT01375764|144526393|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-27.82|STANDARD_ERROR_OF_MEAN|4.12|<|0.001|TWO_SIDED|95.0|-35.97|-19.67||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|ANCOVA|The ANCOVA model included treatment group (3 evolocumab alone dose groups and the ezetimibe group) and the stratification factors.|Ezetimibe is the reference.|The null hypothesis was that there was no mean difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and ezetimibe, and the alternative hypothesis was that a mean difference did exist.||-19.67|-35.97|<0.001
72497984|NCT01375764|144526393|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Tretament Difference|-26.01|STANDARD_ERROR_OF_MEAN|4.08|<|0.001|TWO_SIDED|95.0|-34.08|-17.93||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|ANCOVA|The ANCOVA model included treatment group (3 evolocumab alone dose groups and the ezetimibe group) and the stratification factors.|Ezetimibe is the reference.|The null hypothesis was that there was no mean difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and ezetimibe, and the alternative hypothesis was that a mean difference did exist.||-17.93|-34.08|<0.001
72497985|NCT01375764|144526394|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-47.29|STANDARD_ERROR_OF_MEAN|3.22|<|0.001|TWO_SIDED|95.0|-53.73|-40.84||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group (evolocumab + ezetimibe and ezetimibe alone) and the stratification factors.|Ezetimibe is the reference.|The null hypothesis was that there was no mean difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab + ezetimibe and ezetimibe alone, and the alternative hypothesis was that a mean difference did exist.||-40.84|-53.73|<0.001
72561136|NCT04640194|144652827|OTHER||Median Difference (Net)|0.1|STANDARD_ERROR_OF_MEAN|3.6||0.9856|TWO_SIDED|95.0|-7.5|7.6|||ANCOVA||Calculated as alteplase dose group - standard of care alone.|Unadjusted mean difference: A restricted maximum likelihood (REML) based Analysis of Covariance (ANCOVA) was used. Adjustment was made for treatment.||7.6|-7.5|0.9856
72390150|NCT00692341|144288204|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|195.25|||||TWO_SIDED|90.0|99.49|383.18||||||For moderate hepatic impairment, ANOVA was used to compare natural log transformed AUC (0 - ∞) of axitinib (AG-013736) between the control group (normal hepatic function) and moderate hepatic impairment. The point estimates and CIs on the log-scale were back transformed to provide estimates of the ratio of adjusted geometric means (moderate hepatic impairment/normal hepatic function) and 90% CIs for the ratios.||383.18|99.49|
72497986|NCT01375764|144526395|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-76.6|STANDARD_ERROR_OF_MEAN|9.2|<|0.001|TWO_SIDED|95.0|-94.9|-58.3||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group (3 evolocumab alone dose groups and the ezetimibe group) and the stratification factors.|Ezetimibe is the reference.|||-58.3|-94.9|<0.001
72497987|NCT01375764|144526395|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-55.5|STANDARD_ERROR_OF_MEAN|9.3|<|0.001|TWO_SIDED|95.0|-74.0|-37.1||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group (3 evolocumab alone dose groups and the ezetimibe group) and the stratification factors.|Ezetimibe is the reference.|||-37.1|-74.0|<0.001
72497988|NCT01375764|144526395|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-52.6|STANDARD_ERROR_OF_MEAN|9.2|<|0.001|TWO_SIDED|95.0|-70.8|-34.5||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group (3 evolocumab alone dose groups and the ezetimibe group) and the stratification factors.|Ezetimibe is the reference.|||-34.5|-70.8|<0.001
72497989|NCT01375764|144526396|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-91.9|STANDARD_ERROR_OF_MEAN|8.4|<|1|TWO_SIDED|95.0|-108.7|-75.0||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group (evolocumab + ezetimibe and ezetimibe alone) and the stratification factors.|Ezetimibe is the reference.|||-75.0|-108.7|<0001
72497990|NCT01375764|144526397|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-33.6|STANDARD_ERROR_OF_MEAN|3.7|<|0.001|TWO_SIDED|95.0|-40.93|-26.28||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group (3 evolocumab alone dose groups and the ezetimibe group) and the stratification factors.|Ezetimibe is the reference.|||-26.28|-40.93|<0.001
72497991|NCT01375764|144526397|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-26.66|STANDARD_ERROR_OF_MEAN|3.7|<|0.001|TWO_SIDED|95.0|-33.99|-19.32||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group (3 evolocumab alone dose groups and the ezetimibe group) and the stratification factors.|Ezetimibe is the reference.|||-19.32|-33.99|<0.001
72497992|NCT01375764|144526397|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-24.86|STANDARD_ERROR_OF_MEAN|3.67|<|0.001|TWO_SIDED|95.0|-32.13|-17.59||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group (3 evolocumab alone dose groups and the ezetimibe group) and the stratification factors.|Ezetimibe is the reference.|||-17.59|-32.13|<0.001
72497993|NCT01375764|144526398|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-45.0|STANDARD_ERROR_OF_MEAN|2.9|<|0.001|TWO_SIDED|95.0|-50.81|-39.18||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group (evolocumab + ezetimibe and ezetimibe alone) and the stratification factors.|Ezetimibe is the reference.|||-39.18|-50.81|<0.001
72561137|NCT04640194|144652827|OTHER||Mean Difference (Net)|-0.6|STANDARD_ERROR_OF_MEAN|3.8||0.8729|TWO_SIDED|95.0|-8.5|7.3|||ANCOVA||Calculated as alteplase dose group - standard of care alone.|Adjusted mean difference: A restricted maximum likelihood (REML) based Analysis of Covariance (ANCOVA) was used. Adjustment was made for treatment, the number of days under NIV support, baseline D-Dimer level and age.||7.3|-8.5|0.8729
72561138|NCT04640194|144652828|OTHER||Mean Difference (Net)|70.9|STANDARD_ERROR_OF_MEAN|35.8||0.0603|TWO_SIDED|95.0|-3.3|145.1|||ANCOVA||Calculated as alteplase dose group - standard of care alone.|Unadjusted mean difference: A restricted maximum likelihood (REML) based Analysis of Covariance (ANCOVA) was used. Adjustment was made for treatment.||145.1|-3.3|0.0603
72390151|NCT00692341|144288205|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|78.14|||||TWO_SIDED|90.0|38.68|157.82||||||For mild hepatic impairment, ANOVA was used to compare natural log transformed AUClast of axitinib (AG-013736) between the control group (normal hepatic function) and mild hepatic impairment. The point estimates and CIs on the log-scale were back transformed to provide estimates of the ratio of adjusted geometric means (mild hepatic impairment/normal hepatic function) and 90% CIs for the ratios.||157.82|38.68|
72390152|NCT00692341|144288205|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|198.9|||||TWO_SIDED|90.0|98.47|401.74||||||For moderate hepatic impairment, ANOVA was used to compare natural log transformed AUClast of axitinib (AG-013736) between the control group (normal hepatic function) and moderate hepatic impairment. The point estimates and CIs on the log-scale were back transformed to provide estimates of the ratio of adjusted geometric means (moderate hepatic impairment/normal hepatic function) and 90% CIs for the ratios.||401.74|98.47|
72390153|NCT00692341|144288210|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|73.78|||||TWO_SIDED|90.0|37.4|145.56||||||For mild hepatic impairment, ANOVA was used to compare natural log transformed fu of axitinib (AG-013736) between the control group (normal hepatic function) and mild hepatic impairment. The point estimates and CIs on the log-scale were back transformed to provide estimates of the ratio of adjusted geometric means (mild hepatic impairment/normal hepatic function) and 90% CIs for the ratios.||145.56|37.40|
72390154|NCT00692341|144288210|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|100.86|||||TWO_SIDED|90.0|55.58|183.02||||||For moderate hepatic impairment, ANOVA was used to compare natural log transformed fu of axitinib (AG-013736) between the control group (normal hepatic function) and moderate hepatic impairment. The point estimates and CIs on the log-scale were back transformed to provide estimates of the ratio of adjusted geometric means (moderate hepatic impairment/normal hepatic function) and 90% CIs for the ratios.||183.02|55.58|
72390155|NCT00692341|144288211|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|91.43|||||TWO_SIDED|90.0|44.75|186.79||||||For mild hepatic impairment, ANOVA was used to compare natural log transformed CLu/F of axitinib (AG-013736) between the control group (normal hepatic function) and mild hepatic impairment. The point estimates and CIs on the log-scale were back transformed to provide estimates of the ratio of adjusted geometric means (mild hepatic impairment/normal hepatic function) and 90% CIs for the ratios.||186.79|44.75|
72446629|NCT05235750|144409444|OTHER||Mean Difference (Net)|-1.5||||0.34|TWO_SIDED|||||The above p value refers to the difference between post-intervention change and pre-intervention change (or \[(T3-T2)-(T2-T1)\]) for the total FACIT-Sp-12 (revised).|Mixed Models Analysis||The above value represents net difference between post-intervention change and pre-intervention change (or \[(T3-T2)-(T2-T1)\]) for the total FACIT-Sp-12 (revised).|||||.34
72497994|NCT01375764|144526399|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Teatment Difference|-29.88|STANDARD_ERROR_OF_MEAN|3.52|<|0.001|TWO_SIDED|95.0|-36.84|-22.92||Testing based on a significance level of 0.05|ANCOVA|The ANCOVA model included treatment group (3 evolocumab alone dose groups and the ezetimibe group) and the stratification factors.|Ezetimibe is the reference.|||-22.92|-36.84|<0.001
72446630|NCT05235750|144409444|OTHER||Mean Difference (Net)|-3.0||||0.91|TWO_SIDED|||||The above p value refers to the difference between 2 weeks post-intervention change and pre-intervention change (or \[(T4-T2)-(T2-T1)\]) for the total FACIT-Sp-12 (revised).|Mixed Models Analysis||The above value represents net difference between 2 weeks post-intervention change and pre-intervention change (or \[(T4-T2)-(T2-T1)\]) for the total FACIT-Sp-12 (revised).|||||.91
72446631|NCT05235750|144409445|OTHER||Mean Difference (Net)|1.1||||0.14|TWO_SIDED|||||The above p value refers to the difference between post-intervention change and pre-intervention change (or \[(T3-T2)-(T2-T1)\]) for HADS-anxiety subscale (HADS-A).|Mixed Models Analysis||The above value represents net difference between post-intervention change and pre-intervention change (or \[(T3-T2)-(T2-T1)\]) for HADS-anxiety subscale (HADS-A).|We analyzed short- (at 6 weeks post-baseline, T3) and longer-term differences (at 8 weeks post-baseline, T4) for two subscales HADS-A and HADS-D respectively, expecting a larger size of differences at T3. The short-term difference \[(T3-T2)-(T2-T1)\] represents differences between post-intervention change (T3-T2) and pre-intervention change (T2-T1). Longer-term difference \[(T4-T2)-(T2-T1)\] represents differences between 2 weeks post-intervention change (T4-T2) and pre-intervention change (T2-T1).||||.14
72446632|NCT05235750|144409445|OTHER||Mean Difference (Net)|1.2||||0.14|TWO_SIDED|||||The above p value refers to the difference between 2 weeks post-intervention change and pre-intervention change (or \[(T4-T2)-(T2-T1)\]) for HADS-anxiety subscale (HADS-A).|Mixed Models Analysis||The above value represents net difference between 2 weeks post-intervention change and pre-intervention change (or \[(T4-T2)-(T2-T1)\]) for HADS-anxiety subscale (HADS-A).|||||.14
72446633|NCT05235750|144409445|OTHER||Median Difference (Net)|0.6||||0.32|TWO_SIDED|||||The above p value refers to the difference between post-intervention change and pre-intervention change (or \[(T3-T2)-(T2-T1)\]) for HADS-depression subscale (HADS-D).|Mixed Models Analysis||The above value represents net difference between post-intervention change and pre-intervention change (or \[(T3-T2)-(T2-T1)\]) for HADS-depression subscale (HADS-D).|||||.32
72446634|NCT05235750|144409445|OTHER||Mean Difference (Net)|0.9||||0.2|TWO_SIDED|||||The above p value refers to the difference between 2 weeks post-intervention change and pre-intervention change (or \[(T4-T2)-(T2-T1)\]) for HADS-depression subscale (HADS-D).|Mixed Models Analysis||The above value represents net difference between 2 weeks post-intervention change and pre-intervention change (or \[(T4-T2)-(T2-T1)\]) for HADS-depression subscale (HADS-D).|||||.20
72446635|NCT02301910|144409451|NON_INFERIORITY|The calculation was carried out taking into account the power of 80%||||||0.87|||||||ANOVA|||||||0.87
72446636|NCT04770532|144409475|NON_INFERIORITY|Non-inferiority of insulin icodec was considered confirmed if the upper limit of the two-sided 95% confidence interval (CI) for mean treatment difference (insulin icodec minus insulin degludec) was strictly below 0.3%.|Treatment difference|-0.22|||<|0.0001|TWO_SIDED|95.0|-0.37|-0.08|||ANCOVA|||The response and change from baseline in response after 26 weeks were analysed using an analysis of covariance (ANCOVA) model with treatment, region and personal continuous glucose monitoring (CGM) device use as fixed factors, and baseline response as covariate.||-0.08|-0.37|<0.0001
72446637|NCT04938492|144409486|SUPERIORITY||Slope|2.08|||>|0.05|TWO_SIDED||||||Latent growth modeling|||||||>.05
72446638|NCT04938492|144409487|SUPERIORITY||Slope|0.19|||<|0.001|TWO_SIDED||||||Latent growth modeling|||||||<.001
72446639|NCT04938492|144409488|SUPERIORITY||Slope|0.22|||<|0.01|TWO_SIDED||||||Latent growth modeling|||||||<.01
72446640|NCT04938492|144409489|SUPERIORITY||Slope|0.23|||>|0.05|TWO_SIDED||||||Latent growth modeling|||||||>.05
72446641|NCT05177848|144409530|OTHER|||||||0.9793||||||"A linear mixed effects model tested the interaction between group and condition on the rate of substitution~Results:~Condition: X2(6) = 4.30, p = 0.64 Group: X2(1) 0.22, p = 0.64 Condition:Group: X2(6) = 1.15, p = 0.98"|Mixed Models Analysis|||||||0.9793
72446642|NCT05177848|144409531|OTHER|||||||0.29||||||"A linear mixed effects model tested the interaction between group and condition on Q0 (derived intensity).~Results:~Condition: X2(6) = 6.59, p = 0.36 Group: X2(1) = 0.07, p = 0.79 Condition:Group: X2(6) = 7.38, p = 0.29"|Mixed Models Analysis|||||||0.29
72446643|NCT05177848|144409531|OTHER|||||||0.46||||||"A linear mixed effects model tested the interaction between group and condition on Alpha (demand elasticity).~Results:~Condition: X2(6) = 0.0001, p = 1.00 Group: X2(1) = 0.00, p = 0.99 Condition:Group: X2(6) = 5.65, p = 0.46"|Mixed Models Analysis|||||||0.46
72446644|NCT03158714|144409549|SUPERIORITY||Mean Difference (Net)|0.033||||0.005|TWO_SIDED|||||The a priori threshold for statistical significance was .05.|Mixed Models Analysis|Utilized multi-level modeling to account for nested data (individuals within couples), and accounted for time within individual.||||||.005
72561139|NCT04640194|144652828|OTHER||Mean Difference (Final Values)|87.2|STANDARD_ERROR_OF_MEAN|38.5||0.0362|TWO_SIDED|95.0|6.3|168.0|||ANCOVA||Calculated as alteplase dose group - standard of care alone.|Adjusted mean difference: A restricted maximum likelihood (REML) based Analysis of Covariance (ANCOVA) was used. Adjustment was made for treatment, the number of days under NIV support, baseline D-Dimer level, baseline PaO2/FiO2 ratio and age.||168.0|6.3|0.0362
72561140|NCT01994980|144652848|SUPERIORITY||||||<|0.01||||||This is a calculated p value.|Wilcoxon (Mann-Whitney)|||||||<0.01
72446645|NCT03158714|144409549|SUPERIORITY||Mean Difference (Net)|0.02||||0.101|TWO_SIDED|||||The a priori threshold for statistical significance was .05.|Mixed Models Analysis|Utilized multi-level modeling to account for nested data (individuals within couples), and accounted for time within individual.||||||.101
72561141|NCT00096460|144652858|SUPERIORITY_OR_OTHER_LEGACY||Kaplan-Meier Survival Probability|62.7|||||TWO_SIDED|95.0|43.8|89.6||||||||89.6|43.8|
72446646|NCT03158714|144409550|SUPERIORITY||Mean Difference (Net)|3.96|||<|0.001|TWO_SIDED|||||The a priori threshold for statistical significance was .05.|Regression, Linear|Utilized multi-level modeling to account for nested data (individuals within couples), and controlled for baseline levels of outcome in regression.||||||< .001
72446647|NCT03158714|144409550|SUPERIORITY||Mean Difference (Net)|4.09|||<|0.001|TWO_SIDED|||||The a priori threshold for statistical significance was .05.|Regression, Linear|Utilized multi-level modeling to account for nested data (individuals within couples), and controlled for baseline levels of outcome in regression.||||||< .001
72446648|NCT03158714|144409551|SUPERIORITY||Mean Difference (Net)|0.343||||0.003|TWO_SIDED|||||The a priori threshold for statistical significance was .05.|Mixed Models Analysis|Utilized multi-level modeling to account for nested data (individuals within couples), and accounted for time within individual.||||||.003
72446649|NCT03158714|144409551|SUPERIORITY||Mean Difference (Net)|0.172||||0.152|TWO_SIDED|||||The a priori threshold for statistical significance was .05.|Mixed Models Analysis|Utilized multi-level modeling to account for nested data (individuals within couples), and accounted for time within individual.||||||.152
72446650|NCT01160211|144409577|SUPERIORITY||Hazard Ratio (HR)|0.62||||0.0063|TWO_SIDED|95.0|0.45|0.88||Pike estimate of the treatment hazard ratio, \<1 indicates a lower risk compared with trastuzumab + AI.|Log Rank|using a two-sided stratified log-rank test (based on stratification factors)||Null hypothesis H0: λ ≥ 1 or to reject it in favor of the alternative hypothesis HA: λ \<1, where λ is the hazard ratio (HR) between Treatment Group A and Treatment Group B for progression-free survival.||0.88|0.45|0.0063
72446651|NCT01160211|144409579|SUPERIORITY||Hazard Ratio (HR)|0.59|||||TWO_SIDED|95.0|0.44|0.79||||||||0.79|0.44|
72446652|NCT01160211|144409579|SUPERIORITY||Hazard Ratio (HR)|0.87|||||TWO_SIDED|95.0|0.66|1.15||||||||1.15|0.66|
72446653|NCT01160211|144409579|SUPERIORITY||Hazard Ratio (HR)|0.68|||||TWO_SIDED|95.0|0.51|0.92||||||||0.92|0.51|
72446654|NCT01160211|144409585|SUPERIORITY||Least square difference|-1.79|STANDARD_ERROR_OF_MEAN|2.111|||TWO_SIDED|95.0|-5.95|2.36||||||FACT-B total score||2.36|-5.95|
72446655|NCT01160211|144409585|SUPERIORITY||Least square difference|-3.9|STANDARD_ERROR_OF_MEAN|2.13|||TWO_SIDED|95.0|-8.09|0.29||||||FACT-B total score||0.29|-8.09|
72446656|NCT01160211|144409585|SUPERIORITY||Least square difference|-1.5|STANDARD_ERROR_OF_MEAN|1.739|||TWO_SIDED|95.0|-4.92|1.92||||||FACT-G total score||1.92|-4.92|
72446657|NCT01160211|144409585|SUPERIORITY||Least square difference|-3.1|STANDARD_ERROR_OF_MEAN|1.751|||TWO_SIDED|95.0|-6.55|0.34||||||FACT-G total score||0.34|-6.55|
72446658|NCT01160211|144409585|SUPERIORITY||Least square difference|-2.7|STANDARD_ERROR_OF_MEAN|1.502|||TWO_SIDED|95.0|-5.66|0.25||||||FACT-B trial outcome index (TOI)||0.25|-5.66|
72446659|NCT01160211|144409585|SUPERIORITY||Least square difference|-3.61|STANDARD_ERROR_OF_MEAN|1.512|||TWO_SIDED|95.0|-6.59|-0.64||||||FACT-B trial outcome index (TOI)||-0.64|-6.59|
72446660|NCT01160211|144409585|SUPERIORITY||Least square difference|-1.46|STANDARD_ERROR_OF_MEAN|0.69|||TWO_SIDED|95.0|-2.82|-0.11||||||Physical well-being (PWB)||-0.11|-2.82|
72561142|NCT00096460|144652858|SUPERIORITY_OR_OTHER_LEGACY||Kaplan-Meier Survival Probability|85.7||||||95.0|63.3|100.0||||||||100|63.3|
72561143|NCT04773600|144652878|SUPERIORITY||Odds Ratio (OR)|3.19|||<|0.0001|TWO_SIDED|95.0|1.962|5.183|||Cochran-Mantel-Haenszel|Stratified by pooled study site and vIGA-AD randomization strata|Stratified by pooled study site and vIGA-AD randomization strata|vIGA Success at Week 4||5.183|1.962|<0.0001
72561144|NCT04773600|144652879|SUPERIORITY||Odds Ratio (OR)|3.37|||<|0.0001|TWO_SIDED|95.0|1.996|5.687|||Cochran-Mantel-Haenszel|Stratified by pooled study site|Stratified by pooled study site|vIGA Success at Week 4 in Participants with Baseline vIGA = 'Moderate'||5.687|1.996|<0.0001
72561145|NCT04773600|144652880|SUPERIORITY||Odds Ratio (OR)|4.42|||<|0.0001|TWO_SIDED|95.0|2.281|8.658|||Cochran-Mantel-Haenszel|Stratified by pooled study site and vIGA-AD randomization strata|Stratified by pooled study site and vIGA-AD randomization strata|vIGA-AD Success at Week 2||8.658|2.281|<0.0001
72561146|NCT04773600|144652881|SUPERIORITY||Odds Ratio (OR)|1.99||||0.1156|TWO_SIDED|95.0|0.832|4.782|||Cochran-Mantel-Haenszel|Stratified by pooled study site and vIGA-AD randomization strata|Stratified by pooled study site and vIGA-AD randomization strata|vIGA-AD Success at Week 1||4.782|0.832|0.1156
72561147|NCT04773600|144652882|SUPERIORITY||Odds Ratio (OR)|2.71||||0.0014|TWO_SIDED|95.0|1.448|5.066|||Cochran-Mantel-Haenszel|Stratified by pooled study site and vIGA-AD randomization strata|Stratified by pooled study site and vIGA-AD randomization strata|≥4-Point Reduction in WI-NRS at Week 4||5.066|1.448|0.0014
72561148|NCT04773600|144652883|SUPERIORITY||Odds Ratio (OR)|3.55||||0.0015|TWO_SIDED|95.0|1.591|7.927|||Cochran-Mantel-Haenszel|Stratified by pooled study site and vIGA-AD randomization strata|Stratified by pooled study site and vIGA-AD randomization strata|≥4-Point Reduction in WI-NRS at Week 2||7.927|1.591|0.0015
72561149|NCT04773600|144652884|SUPERIORITY||Odds Ratio (OR)|7.84||||0.002|TWO_SIDED|95.0|1.717|35.764|||Cochran-Mantel-Haenszel|Stratified by pooled study site and vIGA-AD randomization strata|Stratified by pooled study site and vIGA-AD randomization strata|≥4-Point Reduction in WI-NRS at Week 1||35.764|1.717|0.0020
72561150|NCT04773600|144652885|SUPERIORITY||Odds Ratio (OR)|3.23|||<|0.0001|TWO_SIDED|95.0|2.108|4.964|||Cochran-Mantel-Haenszel|Stratified by pooled study site and vIGA-AD randomization strata|Stratified by pooled study site and vIGA-AD randomization strata|EASI-75 at Week 4||4.964|2.108|<0.0001
72561151|NCT04773600|144652886|SUPERIORITY||Odds Ratio (OR)|3.39|||<|0.0001|TWO_SIDED|95.0|2.191|5.24|||Cochran-Mantel-Haenszel|Stratified by pooled study site and vIGA-AD randomization strata|Stratified by pooled study site and vIGA-AD randomization strata|vIGA-AD Score of 'Clear' or 'Almost Clear' at Week 4||5.240|2.191|<0.0001
72561152|NCT04773600|144652887|SUPERIORITY||Odds Ratio (OR)|3.5|||<|0.0001|TWO_SIDED|95.0|2.097|5.854|||Cochran-Mantel-Haenszel|Stratified by pooled study site and vIGA-AD randomization strata|Stratified by pooled study site and vIGA-AD randomization strata|vIGA-AD Score of 'Clear' or 'Almost Clear' at Week 2||5.854|2.097|<0.0001
72561153|NCT04773600|144652888|SUPERIORITY||Odds Ratio (OR)|2.56||||0.005|TWO_SIDED|95.0|1.312|4.993|||Cochran-Mantel-Haenszel|Stratified by pooled study site and vIGA-AD randomization strata|Stratified by pooled study site and vIGA-AD randomization strata|vIGA-AD Score of 'Clear' or 'Almost Clear' at Week 1||4.993|1.312|0.0050
72561154|NCT00377572|144652897|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Mixed Models Analysis|Linear mixed-effects models w/ random intercept and slope (to account for within-subject correlation over time) and visit and group as fixed effects.||Maximum Symptom Day Comparison||||<0.001
72561155|NCT00377572|144652898|SUPERIORITY_OR_OTHER|||||||0.04||95.0|||||Mixed Models Analysis|Linear mixed-effects models w/ random intercept and slope (to account for within-subject correlation over time) and visit and group as fixed effects.||||||0.04
72561156|NCT00377572|144652899|SUPERIORITY_OR_OTHER|||||||0.1111||95.0|||||Mixed Models Analysis|Linear mixed-effects models w/ random intercept (to account for within-subject correlation) and visit and group as fixed effects.||||||0.1111
72446661|NCT01160211|144409585|SUPERIORITY||Least square difference|-1.54|STANDARD_ERROR_OF_MEAN|0.693|||TWO_SIDED|95.0|-2.9|-0.18||||||Physical well-being (PWB)||-0.18|-2.90|
72446662|NCT01160211|144409585|SUPERIORITY||Least square difference|0.39|STANDARD_ERROR_OF_MEAN|0.711|||TWO_SIDED|95.0|-1.01|1.79||||||Social family wellbeing (SWB)||1.79|-1.01|
72561157|NCT00377572|144652900|SUPERIORITY_OR_OTHER|||||||0.007||95.0|||||Mixed Models Analysis|Linear mixed-effects models w/ random intercept and slope (to account for within-subject correlation over time) and visit and group as fixed effects.||Childhood Asthma Control Test comparison||||0.007
72561158|NCT00377572|144652901|SUPERIORITY_OR_OTHER|||||||0.54||95.0|||||Mixed Models Analysis|Linear mixed-effects models w/ random intercept and slope (to account for within-subject correlation over time) and visit and group as fixed effects.||Asthma Control Test comparison||||0.54
72390156|NCT00692341|144288211|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|50.78|||||TWO_SIDED|90.0|27.14|95.03||||||For moderate hepatic impairment, ANOVA was used to compare natural log transformed CLu/F of axitinib (AG-013736) between the control group (normal hepatic function) and moderate hepatic impairment. The point estimates and CIs on the log-scale were back transformed to provide estimates of the ratio of adjusted geometric means (moderate hepatic impairment/normal hepatic function) and 90% CIs for the ratios.||95.03|27.14|
72390157|NCT00692341|144288212|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|103.09|||||TWO_SIDED|90.0|51.53|206.22||||||For mild hepatic impairment, ANOVA was used to compare natural log transformed Vzu/F of axitinib (AG-013736) between the control group (normal hepatic function) and mild hepatic impairment. The point estimates and CIs on the log-scale were back transformed to provide estimates of the ratio of adjusted geometric means (mild hepatic impairment/normal hepatic function) and 90% CIs for the ratios.||206.22|51.53|
72390158|NCT00692341|144288212|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|76.06|||||TWO_SIDED|90.0|41.41|139.73||||||For moderate hepatic impairment, ANOVA was used to compare natural log transformed Vzu/F of axitinib (AG-013736) between the control group (normal hepatic function) and moderate hepatic impairment. The point estimates and CIs on the log-scale were back transformed to provide estimates of the ratio of adjusted geometric means (moderate hepatic impairment/normal hepatic function) and 90% CIs for the ratios.||139.73|41.41|
72390159|NCT00692341|144288213|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|109.38|||||TWO_SIDED|90.0|53.54|223.47||||||For mild hepatic impairment, ANOVA was used to compare natural log transformed AUC (0 - ∞)u of axitinib (AG-013736) between the control group (normal hepatic function) and mild hepatic impairment. The point estimates and CIs on the log-scale were back transformed to provide estimates of the ratio of adjusted geometric means (mild hepatic impairment/normal hepatic function) and 90% CIs for the ratios.||223.47|53.54|
72390160|NCT00692341|144288213|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|196.92|||||TWO_SIDED|90.0|105.23|368.49||||||For moderate hepatic impairment, ANOVA was used to compare natural log transformed AUC (0 - ∞)u of axitinib (AG-013736) between the control group (normal hepatic function) and moderate hepatic impairment. The point estimates and CIs on the log-scale were back transformed to provide estimates of the ratio of adjusted geometric means (moderate hepatic impairment/normal hepatic function) and 90% CIs for the ratios.||368.49|105.23|
72390161|NCT00692341|144288214|SUPERIORITY_OR_OTHER||Adjusted ratio of geometric means|111.65|||||TWO_SIDED|90.0|54.35|229.37||||||For mild hepatic impairment, ANOVA was used to compare natural log transformed AUClastu of axitinib (AG-013736) between the control group (normal hepatic function) and mild hepatic impairment. The point estimates and CIs on the log-scale were back transformed to provide estimates of the ratio of adjusted geometric means (mild hepatic impairment/normal hepatic function) and 90% CIs for the ratios.||229.37|54.35|
72390162|NCT00692341|144288214|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|200.6|||||TWO_SIDED|90.0|106.68|377.2||||||For moderate hepatic impairment, ANOVA was used to compare natural log transformed AUClastu of axitinib (AG-013736) between the control group (normal hepatic function) and moderate hepatic impairment. The point estimates and CIs on the log-scale were back transformed to provide estimates of the ratio of adjusted geometric means (moderate hepatic impairment/normal hepatic function) and 90% CIs for the ratios.||377.20|106.68|
72390163|NCT00692341|144288215|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|106.82|||||TWO_SIDED|90.0|58.22|195.99||||||For mild hepatic impairment, ANOVA was used to compare natural log transformed Cmaxu of axitinib (AG-013736) between the control group (normal hepatic function) and mild hepatic impairment. The point estimates and CIs on the log-scale were back transformed to provide estimates of the ratio of adjusted geometric means (mild hepatic impairment/normal hepatic function) and 90% CIs for the ratios.||195.99|58.22|
72390164|NCT00692341|144288215|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|128.76|||||TWO_SIDED|90.0|75.62|219.25||||||For moderate hepatic impairment, ANOVA was used to compare natural log transformed Cmaxu of axitinib (AG-013736) between the control group (normal hepatic function) and moderate hepatic impairment. The point estimates and CIs on the log-scale were back transformed to provide estimates of the ratio of adjusted geometric means (moderate hepatic impairment/normal hepatic function) and 90% CIs for the ratios.||219.25|75.62|
72390165|NCT00864383|144288216|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was defined as a between-group difference of less than 6 percentage points in the upper boundary of the two-sided 97.5% Wald confidence interval for the difference in proportion of patients with an unfavorable outcome.|Adjusted difference in proportions|6.1|||||TWO_SIDED|97.5|1.7|10.5|||||Adjusted difference from control in proportion of unfavorable outcome - percentage points|||10.5|1.7|
72390166|NCT00864383|144288216|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was defined as a between-group difference of less than 6 percentage points in the upper boundary of the two-sided 97.5% Wald confidence interval for the proportion of patients with an unfavorable outcome.|Adjusted difference from control|11.4|||||TWO_SIDED|97.5|6.7|16.1|||||Adjusted difference from control in rate of unfavorable outcome- percentage points|||16.1|6.7|
72390167|NCT03385564|144288271|OTHER|Percentage of patients with CRR at Week 52 without renal flare were analysed using a logistic regression model. Factors in the model included treatment and the covariates: race (Asian versus (vs.) non-Asian) and proteinuria \<3 gram (g)/day vs. ≥3 g/day (or Urine protein (UP)/ Urine creatinine (UC) \<3 vs. UP/UC ≥3) at screening.|Difference|-5.68||||0.7957|TWO_SIDED|80.0|-34.192|22.825|||Regression, Logistic||The difference was calculated as value from BI 120 milligrams group minus value from Placebo group. Confidence intervals calculated using the delta method.|||22.825|-34.192|0.7957
72446663|NCT01160211|144409585|SUPERIORITY||Least square difference|-0.55|STANDARD_ERROR_OF_MEAN|0.715|||TWO_SIDED|95.0|-1.96|0.86||||||Social family wellbeing (SWB)||0.86|-1.96|
72561159|NCT00377572|144652902|SUPERIORITY_OR_OTHER|||||||0.3||95.0|||||Mixed Models Analysis|Linear mixed-effects models w/ random intercept and slope (to account for within-subject correlation over time) and visit and group as fixed effects.||FEV1 % of predicted value comparison||||0.30
72446664|NCT01160211|144409585|SUPERIORITY||Least square difference|0.54|STANDARD_ERROR_OF_MEAN|0.568|||TWO_SIDED|95.0|-0.57|1.66||||||Emotional wellbeing (EWB)||1.66|-0.57|
72446665|NCT01160211|144409585|SUPERIORITY||Least square difference|0.4|STANDARD_ERROR_OF_MEAN|0.571|||TWO_SIDED|95.0|-0.72|1.53||||||Emotional wellbeing (EWB)||1.53|-0.72|
72446666|NCT01160211|144409585|SUPERIORITY||Least square difference|-0.99|STANDARD_ERROR_OF_MEAN|0.646|||TWO_SIDED|95.0|-2.26|0.28||||||Functional wellbeing (FWB)||0.28|-2.26|
72446667|NCT01160211|144409585|SUPERIORITY||Least square difference|-1.32|STANDARD_ERROR_OF_MEAN|0.649|||TWO_SIDED|95.0|-2.6|-0.04||||||Functional wellbeing (FWB)||-0.04|-2.60|
72446668|NCT01160211|144409585|SUPERIORITY||Least square difference|-0.35|STANDARD_ERROR_OF_MEAN|0.665|||TWO_SIDED|95.0|-1.66|0.95||||||Breast cancer subscale (BCS)||0.95|-1.66|
72561160|NCT00377572|144652903|SUPERIORITY_OR_OTHER|||||||0.81||95.0|||||Mixed Models Analysis|Linear mixed-effects models w/ random intercept and slope (to account for within-subject correlation over time) and visit and group as fixed effects.||FEV1:FVC ×100 comparison||||0.81
72561161|NCT00377572|144652904|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Mixed Models Analysis|Linear mixed-effects models w/ random intercept and slope (to account for within-subject correlation over time) and visit and group as fixed effects.||||||<0.0001
72561162|NCT00377572|144652905|SUPERIORITY_OR_OTHER|||||||0.12||95.0|||||Mixed Models Analysis|Linear mixed-effects models w/ random intercept and slope (to account for within-subject correlation over time) and visit and group as fixed effects.||Percent Adherence Comparison||||0.12
72561163|NCT00377572|144652906|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||Mixed Models Analysis|Linear mixed-effects models w/ random intercept and slope (to account for within-subject correlation over time) and visit and group as fixed effects.||Step level 1- 2 (mild asthma) Percent Comparison||||0.001
72561164|NCT00377572|144652907|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Mixed Models Analysis|Linear mixed-effects models w/ random intercept and slope (to account for within-subject correlation over time) and visit and group as fixed effects.||Step level 4 - 6 (severe asthma)percent comparison||||<0.001
72446669|NCT01160211|144409585|SUPERIORITY||Least square difference|-0.83|STANDARD_ERROR_OF_MEAN|0.668|||TWO_SIDED|95.0|-2.14|0.48||||||Breast cancer subscale (BCS)||0.48|-2.14|
72446670|NCT04342494|144409614|EQUIVALENCE|Symptom-level change estimates were adjusted for baseline PHQ-9 score via analysis of covariance.||||||0.31|||||||ANCOVA|||||||0.31
72446671|NCT04342494|144409615|EQUIVALENCE|Average mood score obtained from daily measurements analyzed via analysis of variance||||||0.0073|||||||ANOVA|||||||0.0073
72446672|NCT04342494|144409616|EQUIVALENCE|Symptom-level change estimates were adjusted for baseline PANSI-PI score via analysis of covariance||||||0.03|||||||ANCOVA|||||||0.03
72446673|NCT04342494|144409617|EQUIVALENCE|Symptom-level change estimates were adjusted for baseline PANSI-NSI score via analysis of covariance||||||0.71|||||||ANCOVA|||||||0.71
72497995|NCT01375764|144526399|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-22.13|STANDARD_ERROR_OF_MEAN|3.52|<|0.001|TWO_SIDED|95.0|-29.1|-15.16||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group (3 evolocumab alone dose groups and the ezetimibe group) and the stratification factors.|Ezetimibe is the reference.|||-15.16|-29.10|<0.001
72561165|NCT00377572|144652908|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Mixed Models Analysis|Linear mixed-effects models w/ random intercept and slope (to account for within-subject correlation over time) and visit and group as fixed effects.||Inhaled glucocorticoids prescribed - mcg per day comparison||||<0.001
72561166|NCT00377572|144652909|SUPERIORITY_OR_OTHER|||||||0.003||95.0|||||Mixed Models Analysis|Linear mixed-effects models w/ random intercept and slope (to account for within-subject correlation over time) and visit and group as fixed effects.||Comparison percent prescribed long-acting beta 2 agonists||||0.003
72446674|NCT04342494|144409618|EQUIVALENCE|Symptom-level change estimates were adjusted for baseline GAD-7 score via analysis of covariance||||||0.31|||||||ANCOVA|||||||0.31
72446675|NCT04806451|144409620|SUPERIORITY||LS Mean Difference|-267.775|STANDARD_ERROR_OF_MEAN|68.313||0.0002|TWO_SIDED|95.0|-403.427|-132.124|||ANCOVA|||||-132.124|-403.427|0.0002
72446676|NCT05835336|144409627|SUPERIORITY|Considering the exploratory nature of the study, a sample size of at least 0.5 (Cohen's D) for a 2-Tailed test, at alpha-0.05 with a power of 80%, was chosen to detect significant within-subject effects.|Mean Difference (Final Values)|7.45|||<|0.001|TWO_SIDED||||||t-test, 2 sided|||||||<0.001
72446677|NCT05835336|144409628|SUPERIORITY|Considering the exploratory nature of the study, a sample size of at least 0.5 (Cohen's D) for a 2-Tailed test, at alpha-0.05 with a power of 80%, was chosen to detect significant within-subject effects.|Mean Difference (Final Values)|3.9|||<|0.001|TWO_SIDED||||||t-test, 2 sided|||||||<0.001
72446678|NCT05835336|144409629|SUPERIORITY|Considering the exploratory nature of the study, a sample size of at least 0.5 (Cohen's D) for a 2-Tailed test, at alpha-0.05 with a power of 80%, was chosen to detect significant within-subject effects.|Mean Difference (Final Values)|3.55||||0.001|TWO_SIDED||||||t-test, 2 sided|||||||0.001
72446679|NCT05835336|144409630|SUPERIORITY|Considering the exploratory nature of the study, a sample size of at least 0.5 (Cohen's D) for a 2-Tailed test, at alpha-0.05 with a power of 80%, was chosen to detect significant within-subject effects.|Mean Difference (Final Values)|5.16||||0.032|TWO_SIDED||||||t-test, 2 sided|||||||0.032
72446680|NCT05835336|144409632|SUPERIORITY|Considering the exploratory nature of the study, a sample size of at least 0.5 (Cohen's D) for a 2-Tailed test, at alpha-0.05 with a power of 80%, was chosen to detect significant within-subject effects.|Mean Difference (Final Values)|7.58||||0.035|TWO_SIDED||||||t-test, 2 sided|||||||0.035
72561167|NCT00377572|144652910|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||Regression, Logistic|Hospitalizations were summed over the course of the double-blind \& analyzed with logistic regression (LR) of 'any' vs. 'none'. The LR was unadjusted.||||||0.02
72446681|NCT05835336|144409633|SUPERIORITY|Considering the exploratory nature of the study, a sample size of at least 0.5 (Cohen's D) for a 2-Tailed test, at alpha-0.05 with a power of 80%, was chosen to detect significant within-subject effects.|Mean Difference (Final Values)|-1.13||||0.521|TWO_SIDED||||||t-test, 2 sided|||||||.521
72446682|NCT02023866|144409756|OTHER|||||||0.1875|||||||Wilcoxon Signed Rank|||Section I - Current Function Null hypothesis = change from baseline is 0.||||0.1875
72446683|NCT02023866|144409756|OTHER|||||||1|||||||Wilcoxin Signed Rank|||Section II - System Specific Involvement Null hypothesis = change from baseline is 0.||||1.0000
72446684|NCT02023866|144409756|OTHER|||||||0.0781|||||||Wilcoxin Signed Rank|||Section III - Current Clinical Assessment Null hypothesis = change from baseline is 0.||||0.0781
72619363|NCT04535362|144769405|SUPERIORITY||Mean Difference (Net)|1.26|STANDARD_ERROR_OF_MEAN|0.98||0.2|TWO_SIDED||||||Mixed Models Analysis|||The fixed effects in the mixed models were infusion rate (2.5 minutes, 5 minutes and 10 minutes (placebo)), cigarette condition (menthol vs. non-menthol), and their interaction. We also controlled for order effects of cigarette condition by including session in the models Subject was a clustering factor and different variance-covariance structures were considered within each condition and subject. The best-fitting structure was selected based on Schwartz's Bayesian Criterion.||||0.20
72390168|NCT03385564|144288271|OTHER|Percentage of patients with CRR at Week 52 without renal flare were analysed using a logistic regression model. Factors in the model included treatment and the covariates: race (Asian versus (vs.) non-Asian) and proteinuria \<3 gram (g)/day vs. ≥3 g/day (or Urine protein (UP)/ Urine creatinine (UC) \<3 vs. UP/UC ≥3) at screening.|Difference|-9.37||||0.5811|TWO_SIDED|80.0|-31.178|12.44|||Regression, Logistic||The difference was calculated as value from BI 180 milligrams group minus value from Placebo group. Confidence intervals calculated using the delta method.|||12.440|-31.178|0.5811
72390169|NCT03385564|144288271|OTHER|Percentage of patients with CRR at Week 52 without renal flare were analysed using a logistic regression model. Factors in the model included treatment and the covariates: race (Asian versus (vs.) non-Asian) and proteinuria \<3 gram (g)/day vs. ≥3 g/day (or Urine protein (UP)/ Urine creatinine (UC) \<3 vs. UP/UC ≥3) at screening.|Difference|1.97||||0.8972|TWO_SIDED|80.0|-17.534|21.48|||Regression, Logistic||The difference was calculated as value from BI 240 milligrams group minus value from Placebo group. Confidence intervals calculated using the delta method.|||21.480|-17.534|0.8972
72446685|NCT02023866|144409756|OTHER|||||||0.2941|||||||t-test, 2 sided|One-sample t-test||Section IV - Quality of Life Null hypothesis = change from baseline is 0.||||0.2941
72619364|NCT01429623|144769501|SUPERIORITY||Odds Ratio (OR)|1.55|||<|0.16|TWO_SIDED|95.0|0.74|3.25|||Log Rank|||||3.25|0.74|<0.16
72619365|NCT01429623|144769502|SUPERIORITY||Mean Difference (Net)|0.37|STANDARD_ERROR_OF_MEAN|0.24|<|0.61|TWO_SIDED||||||Mixed Models Analysis|||||||<0.61
72619366|NCT01429623|144769503|SUPERIORITY||Mean Difference (Net)|-0.066|STANDARD_ERROR_OF_MEAN|0.085|<|0.32|TWO_SIDED||||||Mixed Models Analysis|||||||<0.32
72390170|NCT03385564|144288272|OTHER||Difference|-9.14||||0.825|TWO_SIDED|80.0|-32.83|17.02|||Barnard test||The difference was calculated as value from BI 120 milligrams group minus value from Placebo group. Confidence intervals calculated using the Newcombe method.|||17.02|-32.83|0.8250
72390171|NCT03385564|144288272|OTHER||Difference|-21.23||||0.2562|TWO_SIDED|80.0|-39.44|0.51|||Barnard test||The difference was calculated as value from BI 180 milligrams group minus value from Placebo group. Confidence intervals calculated using the Newcombe method.|||0.51|-39.44|0.2562
72390172|NCT03385564|144288272|OTHER||Difference|-2.0||||0.9632|TWO_SIDED|80.0|-20.45|16.62|||Barnard test||The difference was calculated as value from BI 240 milligrams group minus value from Placebo group. Confidence intervals calculated using the Newcombe method.|||16.62|-20.45|0.9632
72390173|NCT03385564|144288273|OTHER||Difference|-2.86||||0.9275|TWO_SIDED|80.0|-28.58|21.1|||Barnard test||The difference was calculated as value from BI 120 milligrams group minus value from Placebo group. Confidence intervals calculated using the Newcombe method.|||21.10|-28.58|0.9275
72390174|NCT03385564|144288273|OTHER||Difference|-10.0||||0.6064|TWO_SIDED|80.0|-29.9|10.64|||Barnard test||The difference was calculated as value from BI 180 milligrams group minus value from Placebo group. Confidence intervals calculated using the Newcombe method.|||10.64|-29.90|0.6064
72390175|NCT03385564|144288273|OTHER||Difference|0.0|||||TWO_SIDED|80.0|-18.37|18.07|||||The difference was calculated as value from BI 240 milligrams group minus value from Placebo group. Confidence intervals calculated using the Newcombe method.|||18.07|-18.37|
72390176|NCT03385564|144288274|OTHER||Difference|3.73||||0.9119|TWO_SIDED|80.0|-20.53|29.6|||Barnard test||The difference was calculated as value from BI 120 milligrams group minus value from Placebo group. Confidence intervals calculated using the Newcombe method.|||29.60|-20.53|0.9119
72390177|NCT03385564|144288274|OTHER||Difference|3.73||||0.851|TWO_SIDED|80.0|-16.58|24.31|||Barnard test||The difference was calculated as value from BI 180 milligrams group minus value from Placebo group. Confidence intervals calculated using the Newcombe method.|||24.31|-16.58|0.8510
72390178|NCT03385564|144288274|OTHER||Difference|16.43||||0.3498|TWO_SIDED|80.0|-3.53|34.73|||Barnard test||The difference was calculated as value from BI 240 milligrams group minus value from Placebo group. Confidence intervals calculated using the Newcombe method.|||34.73|-3.53|0.3498
72390179|NCT03385564|144288275|OTHER||Difference|5.43||||0.7921|TWO_SIDED|80.0|-10.19|23.57|||Barnard test||The difference was calculated as value from BI 180 milligrams group minus value from Placebo group. Confidence intervals calculated using the Newcombe method.|||23.57|-10.19|0.7921
72390180|NCT03385564|144288277|OTHER||Difference|32.0||||0.1016|TWO_SIDED|80.0|10.28|44.74|||Barnard test||The difference was calculated as value from BI 120 milligrams group minus value from Placebo group. Confidence intervals calculated using the Newcombe method.|||44.74|10.28|0.1016
72390181|NCT03385564|144288277|OTHER||Difference|-3.71||||0.8323|TWO_SIDED|80.0|-23.79|15.29|||Barnard test||The difference was calculated as value from BI 180 milligrams group minus value from Placebo group. Confidence intervals calculated using the Newcombe method.|||15.29|-23.79|0.8323
72390182|NCT03385564|144288277|OTHER||Difference|7.0||||0.6247|TWO_SIDED|80.0|-10.5|23.31|||Barnard test||The difference was calculated as value from BI 240 milligrams group minus value from Placebo group. Confidence intervals calculated using the Newcombe method.|||23.31|-10.50|0.6247
72390183|NCT00824720|144288303|SUPERIORITY_OR_OTHER||least square mean difference|-0.22|STANDARD_DEVIATION|2.3||0.9737|||||||ANCOVA||Mean difference was calculated as high dose minus placebo.|The alternative hypothesis was that the high dose was different from the placebo.||||0.9737
72390184|NCT00824720|144288303|SUPERIORITY_OR_OTHER||least square mean difference|-1.11|STANDARD_DEVIATION|3.5||0.4711|||||||ANCOVA||The mean difference was calculated as low dose minus placebo.|The alternative hypothesis is that the low dose was different from placebo.||||0.4711
72619367|NCT01429623|144769504|SUPERIORITY||Mean Difference (Net)|0.79|STANDARD_ERROR_OF_MEAN|1.17|<|0.97|TWO_SIDED||||||Mixed Models Analysis|||||||<0.97
72561168|NCT00377572|144652911|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Regression, Logistic|Exacerbations were summed over the course of the double-blind and analyzed with an LR of 'any' versus 'none'. LR adjusted for study site and dosing.||||||<0.001
72561169|NCT00377572|144652912|SUPERIORITY_OR_OTHER|||||||0.84||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.84
72561170|NCT00377572|144652913|SUPERIORITY_OR_OTHER|||||||0.58||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.58
72561171|NCT00769314|144652914|SUPERIORITY_OR_OTHER||Treatment difference|0.0685||||0.0419|TWO_SIDED|95.0|0.0025|0.1339||p-value \< 0.05 considered significant|Chi-squared||Treatment difference was the proportion of patients with aborted lesions in the acyclovir Lauriad group minus the proportion of patients with aborted lesions in the placebo group.|||0.1339|0.0025|0.0419
72561172|NCT00769314|144652915|SUPERIORITY_OR_OTHER|||||||0.0683||||||p-value \< 0.05 considered significant|Log Rank|||||||0.0683
72561173|NCT00769314|144652916|SUPERIORITY_OR_OTHER|||||||0.0033||||||p-value \< 0.05 considered significant|Log Rank|||||||0.0033
72561174|NCT00769314|144652917|SUPERIORITY_OR_OTHER|||||||0.0098||||||p-value \< 0.05 considered significant|Log Rank|||||||0.0098
72561175|NCT00769314|144652918|SUPERIORITY_OR_OTHER|||||||0.8005||||||p-value \< 0.05 considered significant|Log Rank|||||||0.8005
72561176|NCT00769314|144652919|SUPERIORITY_OR_OTHER|||||||0.015||||||p-value \< 0.05 considered significant|Log Rank|||||||0.015
72561177|NCT00769314|144652920|SUPERIORITY_OR_OTHER|||||||0.0412||||||p-value \< 0.05 considered significant|Log Rank|||||||0.0412
72561178|NCT00769314|144652921|SUPERIORITY_OR_OTHER|||||||0.0271||||||p-value \< 0.05 considered significant|Chi-squared|||||||0.0271
72561179|NCT00769314|144652922|SUPERIORITY_OR_OTHER|||||||0.5695||||||p-value \< 0.05 considered significant|Wilcoxon (Mann-Whitney)|||Analysis conducted between treatment groups at Day 1 timepoint.||||0.5695
72561180|NCT00769314|144652922|SUPERIORITY_OR_OTHER|||||||0.1824||||||p-value \< 0.05 considered significant|Wilcoxon (Mann-Whitney)|||Analysis conducted between treatment groups at Day 3 timepoint||||0.1824
72561181|NCT00769314|144652922|SUPERIORITY_OR_OTHER|||||||0.0078||||||p-value \< 0.05 considered significant|Wilcoxon (Mann-Whitney)|||Analysis conducted between treatment groups at the Day 5 timepoint||||0.0078
72390185|NCT03329573|144288339|EQUIVALENCE|The two formulations were considered to be bioequivalent if the 90% confidence interval of AUC(0-infinity) for difference between both treatments fall in the range of 0.80-1.25.|Ratio of Geometrical Mean|1.059|||||TWO_SIDED|90.0|1.006|1.115||||||||1.115|1.006|
72390186|NCT03329573|144288340|EQUIVALENCE|The two formulations were considered to be bioequivalent if the 90% confidence interval of AUC(0-infinity) for difference between both treatments fall in the range of 0.80-1.25.|Ratio of Geometrical Mean|0.996|||||TWO_SIDED|90.0|0.947|1.047||||||||1.047|0.947|
72561182|NCT00769314|144652922|SUPERIORITY_OR_OTHER|||||||0.3303||||||p-value \< 0.05 considered significant|Wilcoxon (Mann-Whitney)|||Analysis conducted between treatment groups at the Day 7 timepoint||||0.3303
72561183|NCT00769314|144652922|SUPERIORITY_OR_OTHER|||||||0.6045||||||p-value \< 0.05 considered significant|Wilcoxon (Mann-Whitney)|||Analysis conducted between treatment groups at the Day 14 timepoint||||0.6045
72561184|NCT00769314|144652923|SUPERIORITY_OR_OTHER|||||||0.0022||||||p-value \< 0.05 considered significant|Chi-squared|||||||0.0022
72561185|NCT04980456|144652934|NON_INFERIORITY|Noninferiority in distance VA was declared if the least squares means difference upper confidence limit was less than 0.05.|Least Squares Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.003|||ONE_SIDED|95.0||0.01||Since a noninferiority hypothesis is being tested, a p-value is not applicable. Confidence limit is being reported and compared to the noninferiority margin.|||LSM results based on mixed effects repeated measures model with both fixed (lens, visit, lens by visit interaction, period, and sequence) and random (subject) effects. Difference = TOTAL30 minus Biofinity|||0.01||
72561186|NCT04832971|144652935|SUPERIORITY||Difference vs. Placebo at Week 24|-51.22|||<|0.0001|TWO_SIDED|95.0|-61.73|-40.7||Model includes treatment arm, study visit, randomization stratification factor (LDL-C at Screening \[≥100 mg/dL vs \<100 mg/dL\]),and baseline value as model terms. Model also includes treatment by visit and treatment by baseline as interaction terms.|Mixed Models Repeated Measures (MMRM)||ARO-ANG3 - Placebo|||-40.70|-61.73|<.0001
72561187|NCT04832971|144652935|SUPERIORITY||||||<|0.0001||||||The adjusted p-value is calculated using the Holm method for multiplicity adjustment.|Holm method|||||||<.0001
72561188|NCT04832971|144652935|SUPERIORITY||Difference vs Placebo at Week 24|-56.56|||<|0.0001|TWO_SIDED|95.0|-67.09|-46.04||Model includes treatment arm, study visit, randomization stratification factor (LDL-C at Screening \[≥100 mg/dL vs \<100 mg/dL\]),and baseline value as model terms. Model also includes treatment by visit and treatment by baseline as interaction terms.|Mixed Models Repeated Measures (MMRM)||ARO-ANG3 - Placebo|||-46.04|-67.09|<.0001
72561189|NCT04832971|144652935|SUPERIORITY||||||<|0.0001||||||The adjusted p-value is calculated using the Holm method for multiplicity adjustment.|Holm method|||||||<.0001
72561190|NCT04832971|144652935|SUPERIORITY||Difference vs. Placebo at Week 24|-63.11|||<|0.0001|TWO_SIDED|95.0|-73.56|-52.66||Model includes treatment arm, study visit, randomization stratification factor (LDL-C at Screening \[≥100 mg/dL vs \<100 mg/dL\]),and baseline value as model terms. Model also includes treatment by visit and treatment by baseline as interaction terms.|Mixed Model with Repeated Measures|||||-52.66|-73.56|<.0001
72561191|NCT04832971|144652935|SUPERIORITY||||||<|0.0001||||||The adjusted p-value is calculated using the Holm method for multiplicity adjustment.|Holm method|||||||<.0001
72561192|NCT04832971|144652937|SUPERIORITY||Difference vs. Placebo at Week 24|-29.2|||<|0.0001|TWO_SIDED|95.0|-38.5|-20.0||Model includes treatment arm, study visit, randomization stratification factor (LDL-C at Screening \[≥100 mg/dL vs \<100 mg/dL\]),and baseline value as model terms. Model also includes treatment by visit and treatment by baseline as interaction terms.|Mixed Models Repeated Measures|||||-20.0|-38.5|<.0001
72619368|NCT00793611|144769509|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.2||||0.07|||||||t-test, 2 sided|19 degrees of freedom||ITT between group differences in change scores compared for behavioral therapy and hypnotherapy groups. Power analysis: This is a pilot study underpowered find between group differences based on our power analysis(a 20% difference between groups would require 88 women, assuming 80% power and α=0.05 based on Freeman's study cited later). The purpose of this pilot study is to evaluate the feasibility of the larger study and determine the appropriate control intervention and outcomes||||.07
72619369|NCT00793611|144769510|SUPERIORITY_OR_OTHER|||||||0.17||95.0|||||t-test, 2 sided|||intent to treat.||||.17
72446686|NCT02432404|144409769|OTHER||Mean Difference (Final Values)|-0.37||||0.011|TWO_SIDED|||||p\<0.05 is considered statistically significant.|Random effects mixed model|Random effects mixed model: random effects for subject and time category, with unstructured covariance, and AR(1) residuals; and robust SEs.||Mean quantity of G. vaginalis at baseline and during Nuvaring Use (M2-M3)||||0.011
72446687|NCT02432404|144409769|OTHER||Mean Difference (Final Values)|-0.69||||0.008|TWO_SIDED|||||p\<0.05 is considered statistically significant.|Random effects mixed model|Random effects mixed model: random effects for subject and time category, with unstructured covariance, and AR(1) residuals; and robust SEs.||Mean quantity of G. vaginalis at baseline and during Nuvaring Use (M3-M6)||||0.008
72446688|NCT02432404|144409769|OTHER||Mean Difference (Final Values)|0.08||||0.662|TWO_SIDED|||||p\<0.05 is considered statistically significant.|Random effects mixed model|Random effects mixed model: random effects for subject and time category, with unstructured covariance, and AR(1) residuals; and robust SEs.||Mean quantity of L. iners at baseline and during Nuvaring Use (M2-M3)||||0.662
72446689|NCT02432404|144409769|OTHER||Mean Difference (Final Values)|0.48||||0.41|TWO_SIDED|||||p\<0.05 is considered statistically significant.|Random effects mixed model|Random effects mixed model: random effects for subject and time category, with unstructured covariance, and AR(1) residuals; and robust SEs.||Mean quantity of L. iners at baseline and during Nuvaring Use (M3-M6)||||0.41
72446690|NCT02432404|144409769|OTHER||Mean Difference (Final Values)|0.23||||0.164|TWO_SIDED|||||p\<0.05 is considered statistically significant.|Random effects mixed model|Random effects mixed model: random effects for subject and time category, with unstructured covariance, and AR(1) residuals; and robust SEs.||Mean quantity of L. crispatus at baseline and during Nuvaring Use (M2-M3)||||0.164
72446691|NCT02432404|144409769|OTHER||Mean Difference (Final Values)|0.35||||0.183|TWO_SIDED|||||p\<0.05 is considered statistically significant.|Random effects mixed model|||Mean quantity of L. crispatus at baseline and during Nuvaring Use (M3-M6)||||0.183
72446692|NCT02432404|144409769|OTHER||Mean Difference (Final Values)|0.12||||0.506|TWO_SIDED|||||p\<0.05 is considered statistically significant.|Random effects mixed model|Random effects mixed model: random effects for subject and time category, with unstructured covariance, and AR(1) residuals; and robust SEs.||Mean quantity of L. jensenii at baseline and during Nuvaring Use (M2-M3)||||0.506
72446693|NCT02432404|144409769|OTHER||Mean Difference (Final Values)|0.38||||0.119|TWO_SIDED|||||p\<0.05 is considered statistically significant.|Random effects mixed model|Random effects mixed model: random effects for subject and time category, with unstructured covariance, and AR(1) residuals; and robust SEs.||Mean quantity of L. jensenii at baseline and during Nuvaring Use (M3-M6)||||0.119
72497996|NCT01375764|144526399|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-21.38|STANDARD_ERROR_OF_MEAN|3.49|<|0.001|TWO_SIDED|95.0|-28.29|-14.48||Testing based on a signficance level of 0.05.|ANCOVA|The ANCOVA model included treatment group (3 evolocumab alone dose groups and the ezetimibe group) and the stratification factors.|Ezetimibe is the reference.|||-14.48|-28.29|<0.001
72561193|NCT04832971|144652937|SUPERIORITY||Difference vs. Placebo at Week 24|-28.7|||<|0.0001|TWO_SIDED|95.0|-37.9|-19.5||Model includes treatment arm, study visit, randomization stratification factor (LDL-C at Screening \[≥100 mg/dL vs \<100 mg/dL\]),and baseline value as model terms. Model also includes treatment by visit and treatment by baseline as interaction terms.|Mixed Models Repeated Measures|||||-19.5|-37.9|<.0001
72561194|NCT04832971|144652937|SUPERIORITY||Difference vs. Placebo at Week 24|-36.4|||<|0.0001|TWO_SIDED|95.0|-45.5|-27.2||Model includes treatment arm, study visit, randomization stratification factor (LDL-C at Screening \[≥100 mg/dL vs \<100 mg/dL\]),and baseline value as model terms. Model also includes treatment by visit and treatment by baseline as interaction terms.|Mixed Models Repeated Measures|||||-27.2|-45.5|<.0001
72446694|NCT02432404|144409769|OTHER||Mean Difference (Final Values)|0.1||||0.51|TWO_SIDED|||||p\<0.05 is considered statistically significant.|Random effects mixed model|Random effects mixed model: random effects for subject and time category, with unstructured covariance, and AR(1) residuals; and robust SEs.||Mean quantity of Megasphaera at baseline and during Nuvaring Use (M2-M3)||||0.510
72446695|NCT02432404|144409769|OTHER||Mean Difference (Final Values)|-0.3||||0.168|TWO_SIDED|||||p\<0.05 is considered statistically significant.|Random effects mixed model|Random effects mixed model: random effects for subject and time category, with unstructured covariance, and AR(1) residuals; and robust SEs.||Mean quantity of Megasphaera at baseline and during Nuvaring Use (M3-M6)||||0.168
72446696|NCT02432404|144409769|OTHER||Mean Difference (Final Values)|0.07||||0.454|TWO_SIDED|||||p\<0.05 is considered statistically significant.|Random effects mixed model|Random effects mixed model: random effects for subject and time category, with unstructured covariance, and AR(1) residuals; and robust SEs.||Mean quantity of BVAB2 at baseline and during Nuvaring Use (M2-M3)||||0.454
72446697|NCT02432404|144409769|OTHER||Mean Difference (Final Values)|-0.1||||0.471|TWO_SIDED|||||p\<0.05 is considered statistically significant.|Random effects mixed model|Random effects mixed model: random effects for subject and time category, with unstructured covariance, and AR(1) residuals; and robust SEs.||Mean quantity of BVAB2 at baseline and during Nuvaring Use (M3-M6)||||0.471
72446698|NCT04963270|144409771|SUPERIORITY||Difference in Adjusted Mean|-1.02|STANDARD_DEVIATION|0.44||0.0196|TWO_SIDED|95.0|-1.88|-0.16|||ANCOVA and Conditional Mean Imputation|||||-0.16|-1.88|0.0196
72446699|NCT04963270|144409772|SUPERIORITY||Difference in Adjusted Mean|-1.02|STANDARD_ERROR_OF_MEAN|0.41||0.0123|TWO_SIDED|95.0|-1.82|-0.22|||ANCOVA and Conditional Mean Imputation|||||-0.22|-1.82|0.0123
72561195|NCT04832971|144652939|SUPERIORITY||Difference vs. Placebo at Week 24|-18.66|||<|0.0001|TWO_SIDED|95.0|-26.53|-10.8||Model includes treatment arm, study visit, randomization stratification factor (LDL-C at Screening \[≥100 mg/dL vs \<100 mg/dL\]),and baseline value as model terms. Model also includes treatment by visit and treatment by baseline as interaction terms.|Mixed Models Repeated Measures|||||-10.80|-26.53|<.0001
72446700|NCT04963270|144409773|SUPERIORITY||Difference in Response Rate|-12.7||||0.088|TWO_SIDED|95.0|-27.3|1.9|||Cochran-Mantel-Haenszel|||Stratified Analysis||1.9|-27.3|0.088
72446701|NCT04963270|144409774|SUPERIORITY||Difference in Response Rate|-10.5||||0.137|TWO_SIDED|95.0|-24.2|3.3|||Cochran-Mantel-Haenszel|||Stratified Analysis||3.3|-24.2|0.137
72446702|NCT04963270|144409775|SUPERIORITY||Difference in Adjusted Mean|-1.63|STANDARD_ERROR_OF_MEAN|0.6||0.0062|TWO_SIDED|95.0|-2.8|-0.46|||ANCOVA and Conditional Mean Imputation|||||-0.46|-2.80|0.0062
72619370|NCT00793611|144769511|SUPERIORITY_OR_OTHER|||||||0.009||95.0|||||t-test, 2 sided|||intent to treat||||.009
72561196|NCT04832971|144652939|SUPERIORITY||Difference vs. Placebo at Week 24|-15.18||||0.0002|TWO_SIDED|95.0|-23.0|-7.36||Model includes treatment arm, study visit, randomization stratification factor (LDL-C at Screening \[≥100 mg/dL vs \<100 mg/dL\]),and baseline value as model terms. Model also includes treatment by visit and treatment by baseline as interaction terms.|Mixed Models Repeated Measures|||||-7.36|-23.00|0.0002
72561197|NCT04832971|144652939|SUPERIORITY||Difference vs. Placebo at Week 24|-21.9|||<|0.0001|TWO_SIDED|95.0|-29.69|-14.12||Model includes treatment arm, study visit, randomization stratification factor (LDL-C at Screening \[≥100 mg/dL vs \<100 mg/dL\]),and baseline value as model terms. Model also includes treatment by visit and treatment by baseline as interaction terms.|Mixed Models Repeated Measures|||||-14.12|-29.69|<.0001
72390187|NCT03329573|144288341|EQUIVALENCE|The two formulations were considered to be bioequivalent if the 90% confidence interval of AUC(0-t) for difference between both treatments fall in the range of 0.80-1.25.|Ratio of Geometrical Mean|1.064|||||TWO_SIDED|90.0|1.01|1.12||||||||1.120|1.010|
72390188|NCT03329573|144288342|EQUIVALENCE|The two formulations were considered to be bioequivalent if the 90% confidence interval of AUC(0-t) for difference between both treatments fall in the range of 0.80-1.25.|Ratio of Geometrical Mean|0.996|||||TWO_SIDED|90.0|0.949|1.044||||||||1.044|0.949|
72390189|NCT03329573|144288343|EQUIVALENCE|The two formulations were considered to be bioequivalent if the 90% confidence interval of Cmax for difference between both treatments fall in the range of 0.80-1.25.|Ratio of Geometrical Mean|1.024|||||TWO_SIDED|90.0|0.952|1.101||||||||1.101|0.952|
72390190|NCT03329573|144288344|EQUIVALENCE|The two formulations were considered to be bioequivalent if the 90% confidence interval of Cmax for difference between both treatments fall in the range of 0.80-1.25.|Ratio of Geometrical Mean|1.02|||||TWO_SIDED|90.0|0.968|1.074||||||||1.074|0.968|
72390191|NCT00650260|144288369|SUPERIORITY_OR_OTHER|||||||0.027||95.0|||||Fisher Exact|||||||0.027
72390192|NCT00650260|144288370|SUPERIORITY_OR_OTHER|||||||0.078||95.0|||||t-test, 1 sided|||||||0.078
72390193|NCT00650260|144288373|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|||||||1.0
72390194|NCT02513394|144288427|OTHER||Hazard Ratio (HR)|0.96||||0.65|TWO_SIDED|95.0|0.81|1.14|||Log Rank||This two sided p value was stratified by (neo)adjuvant chemotherapy (yes vs no) and age (\<=50 vs \>50).|||1.14|0.81|0.65
72390195|NCT02513394|144288428|OTHER||Hazard Ratio (HR)|0.99|||||TWO_SIDED|95.0|0.82|1.19||||||||1.19|0.82|
72390196|NCT02513394|144288429|OTHER||Hazard Ratio (HR)|1.05|||||TWO_SIDED|95.0|0.87|1.28||||||||1.28|0.87|
72390197|NCT02513394|144288430|OTHER||Hazard Ratio (HR)|1.32|||||TWO_SIDED|95.0|0.98|1.78||||||||1.78|0.98|
72390198|NCT02513394|144288431|OTHER||Hazard Ratio (HR)|0.84|||||TWO_SIDED|95.0|0.57|1.23||||||||1.23|0.57|
72390199|NCT00042289|144288439|SUPERIORITY||Geometric mean ratio|0.62||||0.055|TWO_SIDED|90.0|0.44|0.88||2nd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||0.88|0.44|0.055
72390200|NCT00042289|144288439|SUPERIORITY||Geometric mean ratio|0.64|||<|0.001|TWO_SIDED|90.0|0.55|0.73||3rd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||0.73|0.55|<0.001
72390201|NCT00042289|144288439|SUPERIORITY||Geometric mean ratio|0.68||||0.22|TWO_SIDED|90.0|0.44|1.04||2nd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||1.04|0.44|0.22
72390202|NCT00042289|144288439|SUPERIORITY||Geometric mean ratio|0.6|||<|0.001|TWO_SIDED|90.0|0.49|0.72||3rd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||0.72|0.49|<0.001
72390203|NCT00042289|144288439|SUPERIORITY||Geometric mean ratio|0.76|||<|0.05|TWO_SIDED|90.0|0.64|0.89||2nd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||0.89|0.64|<0.05
72390204|NCT00042289|144288439|SUPERIORITY||Geometric mean ratio|0.71|||<|0.05|TWO_SIDED|90.0|0.57|0.88||3rd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||0.88|0.57|<0.05
72390205|NCT00042289|144288439|SUPERIORITY||Geometric mean ratio|0.98||||0.78|TWO_SIDED|90.0|0.71|1.35||3rd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||1.35|0.71|0.78
72390206|NCT00042289|144288440|SUPERIORITY||Geometric mean ratio|0.51|||<|0.05|TWO_SIDED|90.0|0.42|0.63||2nd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||0.63|0.42|<0.05
72390207|NCT00042289|144288440|SUPERIORITY||Geometric mean ratio|0.73|||<|0.05|TWO_SIDED|90.0|0.63|0.84||3rd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||0.84|0.63|<0.05
72390208|NCT00042289|144288440|SUPERIORITY||Geometric mean ratio|0.58||||0.03|TWO_SIDED|90.0|0.34|0.98||2nd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||0.98|0.34|0.03
72390209|NCT00042289|144288440|SUPERIORITY||Geometric mean ratio|0.67||||0.001|TWO_SIDED|90.0|0.51|0.89||3rd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||0.89|0.51|0.001
72390210|NCT00042289|144288440|SUPERIORITY||Geometric mean ratio|1.34||||0.0684|TWO_SIDED|||||3rd Trimester vs. Postpartum \[Note: Comparison of 2nd Trimester vs. Postpartum was not done due to low sample size.\]|Wilcoxon signed-rank test|||||||0.0684
72390211|NCT00042289|144288440|SUPERIORITY||Geometric mean ratio|0.58|||<|0.05|TWO_SIDED|90.0|0.49|0.68||2nd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||0.68|0.49|<0.05
72390212|NCT00042289|144288440|SUPERIORITY||Geometric mean ratio|0.6|||<|0.05|TWO_SIDED|90.0|0.53|0.68||3rd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||0.68|0.53|<0.05
72390213|NCT00042289|144288441|SUPERIORITY||Geometric mean ratio|0.72||||0.008|TWO_SIDED|90.0|0.6|0.88||3rd Trimester vs. Postpartum|t-test, 2 sided|Paired sample t-test on natural log-transformed PK parameter||||0.88|0.60|0.008
72390214|NCT00042289|144288442|SUPERIORITY||Geometric mean ratio|0.63||||0.002|TWO_SIDED|90.0|0.52|0.75||2nd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||0.75|0.52|0.002
72390215|NCT00042289|144288442|SUPERIORITY||Geometric mean ratio|0.71||||0.0003|TWO_SIDED|90.0|0.63|0.81||3rd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||0.81|0.63|0.0003
72390216|NCT00042289|144288442|SUPERIORITY||Geometric mean ratio|0.57||||0.09|TWO_SIDED|90.0|0.34|0.98||2nd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||0.98|0.34|0.09
72390217|NCT00042289|144288442|SUPERIORITY||Geometric mean ratio|0.67||||0.004|TWO_SIDED|90.0|0.54|0.82||3rd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||0.82|0.54|0.004
72390218|NCT00042289|144288442|SUPERIORITY||Geometric mean ratio|0.79||||0.27|TWO_SIDED|90.0|0.5|1.27||2nd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||1.27|0.50|0.27
72390219|NCT00042289|144288442|SUPERIORITY||Geometric mean ratio|0.86||||0.7|TWO_SIDED|90.0|0.66|1.12||3rd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||1.12|0.66|0.70
72390220|NCT00042289|144288442|SUPERIORITY||Geometric mean ratio|0.62||||0.46|TWO_SIDED|90.0|0.29|1.34||2nd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||1.34|0.29|0.46
72561198|NCT04832971|144652941|SUPERIORITY||Difference vs. Placebo at Week 24|-16.0||||0.0138|TWO_SIDED|95.0|-28.7|-3.3||Model includes treatment arm, study visit, and baseline value as model terms. Model also includes treatment by visit and treatment by baseline as interaction terms.|Mixed Models Repeated Measures|||||-3.3|-28.7|0.0138
72561199|NCT04832971|144652941|SUPERIORITY||Difference vs Placebo at Week 24|-9.3||||0.148|TWO_SIDED|95.0|-22.0|3.3||Model includes treatment arm, study visit, and baseline value as model terms. Model also includes treatment by visit and treatment by baseline as interaction terms.|Mixed Models Repated Measures|||||3.3|-22.0|0.1480
72497997|NCT01375764|144526400|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-38.23|STANDARD_ERROR_OF_MEAN|2.79|<|0.001|TWO_SIDED|95.0|-43.81|-32.64||Testing based on a significance level of 0.05|ANCOVA|The ANCOVA model included treatment group (evolocumab + ezetimibe and ezetimibe alone) and the stratification factors.|Ezetimibe is the reference.|||-32.64|-43.81|<0.001
72497998|NCT01375764|144526401|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-30.95|STANDARD_ERROR_OF_MEAN|3.34|<|0.001|TWO_SIDED|95.0|-37.56|-24.34||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group (3 evolocumab alone dose groups and the ezetimibe group) and the stratification factors.|Ezetimibe is the reference.|||-24.34|-37.56|<0.001
72497999|NCT01375764|144526401|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-23.91|STANDARD_ERROR_OF_MEAN|3.34|<|0.001|TWO_SIDED|95.0|-30.53|-17.29||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group (3 evolocumab alone dose groups and the ezetimibe group) and the stratification factors.|Ezetimibe is the reference.|||-17.29|-30.53|<0.001
72561200|NCT04832971|144652941|SUPERIORITY||Difference vs Placebo at Week 24|-20.2||||0.0019|TWO_SIDED|95.0|-32.8|-7.5||Model includes treatment arm, study visit, and baseline value as model terms. Model also includes treatment by visit and treatment by baseline as interaction terms.|Mxed Models Repeated Measures|||||-7.5|-32.8|0.0019
72561201|NCT04832971|144652943|SUPERIORITY||Difference vs Placebo|-54.26|||<|0.0001|TWO_SIDED|95.0|-62.11|-46.4||Model includes treatment arm, study visit, randomization stratification factor (LDL-C at Screening \[≥100 mg/dL vs \<100 mg/dL\]),and baseline value as model terms. Model also includes treatment by visit and treatment by baseline as interaction terms.|mixed Models Repeated Measures|||||-46.40|-62.11|<.0001
72561202|NCT04832971|144652943|SUPERIORITY||Difference vs Placebo at Week 24|-69.76|||<|0.0001|TWO_SIDED|95.0|-77.58|-61.95||Model includes treatment arm, study visit, randomization stratification factor (LDL-C at Screening \[≥100 mg/dL vs \<100 mg/dL\]),and baseline value as model terms. Model also includes treatment by visit and treatment by baseline as interaction terms.|Mixed Models Repeated Measures|||||-61.95|-77.58|<.0001
72390221|NCT00042289|144288442|SUPERIORITY||Geometric mean ratio|0.94||||0.5|TWO_SIDED|90.0|0.63|1.39||3rd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||1.39|0.63|0.50
72390222|NCT00042289|144288442|SUPERIORITY||Geometric mean ratio|0.76|||<|0.1|TWO_SIDED|90.0|0.57|1.0||2nd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||1.0|0.57|<0.10
72390223|NCT00042289|144288442|SUPERIORITY||Geometric mean ratio|0.56|||<|0.1|TWO_SIDED|90.0|0.42|0.73||3rd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||0.73|0.42|<0.10
72390224|NCT00042289|144288442|SUPERIORITY||Geometric mean ratio|0.47|||<|0.1|TWO_SIDED|90.0|0.33|0.68||2nd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||0.68|0.33|<0.10
72390225|NCT00042289|144288442|SUPERIORITY||Geometric mean ratio|0.44|||<|0.1|TWO_SIDED|90.0|0.36|0.54||3rd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||0.54|0.36|<0.10
72390226|NCT00042289|144288442|SUPERIORITY||Geometric mean ratio|0.74||||0.1875|TWO_SIDED|90.0|0.53|1.04||2nd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||1.04|0.53|0.1875
72390227|NCT00042289|144288442|SUPERIORITY||Geometric mean ratio|0.46||||0.1563|TWO_SIDED|90.0|0.19|1.11||3rd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||1.11|0.19|0.1563
72390228|NCT00042289|144288442|SUPERIORITY||Geometric mean ratio|0.94||||0.241|TWO_SIDED|90.0|0.85|1.03||2nd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||1.03|0.85|0.241
72390229|NCT00042289|144288442|SUPERIORITY||Geometric mean ratio|1.09||||0.837|TWO_SIDED|90.0|0.9|1.32||3rd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||1.32|0.90|0.837
72390230|NCT00042289|144288442|SUPERIORITY||Geometric mean ratio|0.7|||<|0.05|TWO_SIDED|90.0|0.55|0.88||3rd Trimester vs. Postpartum \[Note: Comparison of 2nd Trimester vs. Postpartum was not done due to low sample size.\]|Wilcoxon signed-rank test|||||0.88|0.55|<0.05
72390231|NCT00042289|144288442|SUPERIORITY||Geometric mean ratio|0.8||||0.0046|TWO_SIDED|90.0|0.72|0.89||3rd Trimester vs. Postpartum \[Note: Comparison of 2nd Trimester vs. Postpartum was not done due to low sample size.\]|Wilcoxon signed-rank test|||||0.89|0.72|0.0046
72390232|NCT00042289|144288442|SUPERIORITY||Geometric mean ratio|0.66|||<|0.05|TWO_SIDED|90.0|0.52|0.85||3rd Trimester vs. Postpartum \[Note: Comparison of 2nd Trimester vs. Postpartum was not done due to low sample size.\]|Wilcoxon signed-rank test|||||0.85|0.52|<0.05
72390233|NCT00042289|144288442|SUPERIORITY||||||<|0.05||||||2nd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||||<0.05
72390234|NCT00042289|144288442|SUPERIORITY||||||<|0.05||||||3rd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||||<0.05
72390235|NCT00042289|144288442|SUPERIORITY||||||>|0.05||||||2nd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||||>0.05
72390236|NCT00042289|144288442|SUPERIORITY||||||>|0.05||||||3rd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||||>0.05
72390237|NCT00042289|144288442|SUPERIORITY||||||<|0.05||||||2nd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||||<0.05
72390238|NCT00042289|144288442|SUPERIORITY||||||<|0.05||||||3rd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||||<0.05
72390239|NCT00042289|144288443|SUPERIORITY||Geometric mean ratio|0.97||||0.07|TWO_SIDED|90.0|0.83|1.13||3rd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||1.13|0.83|0.07
72390240|NCT00042289|144288443|SUPERIORITY||Geometric mean ratio|0.77|||<|0.05|TWO_SIDED|90.0|0.61|0.96||2nd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||0.96|0.61|<0.05
72390241|NCT00042289|144288443|SUPERIORITY||Geometric mean ratio|0.8|||<|0.05|TWO_SIDED|90.0|0.62|1.03||3rd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||1.03|0.62|<0.05
72390242|NCT00042289|144288444|SUPERIORITY||Geometric mean of ratio|0.81||||0.148|TWO_SIDED|90.0|0.64|1.01||2nd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||1.01|0.64|0.148
72390243|NCT00042289|144288444|SUPERIORITY||Geometric mean of ratio|0.71|||<|0.001|TWO_SIDED|90.0|0.62|0.81||3rd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||0.81|0.62|<0.001
72446703|NCT04963270|144409776|SUPERIORITY||Difference in adjusted Mean|-1.68|STANDARD_ERROR_OF_MEAN|0.57||0.0034|TWO_SIDED|95.0|-2.8|-0.56|||ANCOVA and Conditional Mean Imputation|||||-0.56|-2.80|0.0034
72446704|NCT04963270|144409777|SUPERIORITY||Difference in Adjusted Mean|-1.51|STANDARD_ERROR_OF_MEAN|0.94||0.1094|TWO_SIDED|95.0|-3.36|0.34|||ANCOVA and Conditional Mean Imputation|||||0.34|-3.36|0.1094
72561203|NCT04832971|144652943|SUPERIORITY||Difference vs Placebo at Week 24|-73.69|||<|0.0001|TWO_SIDED|95.0|-81.44|-65.93||Model includes treatment arm, study visit, randomization stratification factor (LDL-C at Screening \[≥100 mg/dL vs \<100 mg/dL\]),and baseline value as model terms. Model also includes treatment by visit and treatment by baseline as interaction terms.|Mixed Models Repeated Measures|||||-65.93|-81.44|<.0001
72446705|NCT04963270|144409778|SUPERIORITY||Difference in Adjusted Mean|-1.39|STANDARD_ERROR_OF_MEAN|0.85||0.0999|TWO_SIDED|95.0|-3.05|0.27|||ANCOVA and Conditional Mean Imputation|||||0.27|-3.05|0.0999
72446706|NCT04963270|144409779|SUPERIORITY||Difference in Adjusted Mean|-2.2|STANDARD_ERROR_OF_MEAN|1.1||0.0456|TWO_SIDED|95.0|-4.36|-0.04|||ANCOVA and Conditional Mean Imputation|||||-0.04|-4.36|0.0456
72446707|NCT04963270|144409780|SUPERIORITY||Difference in Adjusted Mean|-2.11|STANDARD_ERROR_OF_MEAN|1.02||0.0382|TWO_SIDED|95.0|-4.1|-0.11|||ANCOVA and Conditional Mean Imputation|||||-0.11|-4.10|0.0382
72446708|NCT04963270|144409781|SUPERIORITY|Stratified Analysis|Difference in Response Rate|-18.7||||0.013|TWO_SIDED|95.0|-33.5|-3.9|||Cochran-Mantel-Haenszel|||||-3.9|-33.5|0.013
72561204|NCT04832971|144652945|SUPERIORITY||Difference vs Placebo at Week 24|-12.0||||0.0039|TWO_SIDED|95.0|-20.2|-3.9||Model includes treatment arm, study visit, randomization stratification factor (LDL-C at Screening \[≥100 mg/dL vs \<100 mg/dL\]),and baseline value as model terms. Model also includes treatment by visit and treatment by baseline as interaction terms.|Mixed Models Repeated Measures|||||-3.9|-20.2|0.0039
72561205|NCT04832971|144652945|SUPERIORITY||Difference vs Placebo at Week 24|-21.6|||<|0.0001|TWO_SIDED|95.0|-29.8|-13.4||Model includes treatment arm, study visit, randomization stratification factor (LDL-C at Screening \[≥100 mg/dL vs \<100 mg/dL\]),and baseline value as model terms. Model also includes treatment by visit and treatment by baseline as interaction terms.|Mixed Models Repeated Measures|||||-13.4|-29.8|<.0001
72446709|NCT04963270|144409782|SUPERIORITY|Stratified Analysis|Difference in Response Rate|-22.0||||0.002|TWO_SIDED|95.0|-36.2|-7.9|||Cochran-Mantel-Haenszel|||||-7.9|-36.2|0.002
72446710|NCT04963270|144409783|SUPERIORITY||Difference in Adjusted Mean|-2.99|STANDARD_ERROR_OF_MEAN|0.81||0.0002|TWO_SIDED|95.0|-4.57|-1.41|||ANCOVA and Conditional Mean Imputation|||||-1.41|-4.57|0.0002
72446711|NCT04963270|144409784|SUPERIORITY||Difference in Adjusted Mean|-3.0|STANDARD_ERROR_OF_MEAN|0.75|<|0.0001|TWO_SIDED|95.0|-4.47|-1.53|||ANCOVA and Conditional Mean Imputation|||||-1.53|-4.47|<0.0001
72446712|NCT04963270|144409785|SUPERIORITY||Difference in Response Rate|-21.0||||0.004|TWO_SIDED|95.0|-35.4|-6.6|||Cochran-Mantel-Haenszel|||||-6.6|-35.4|0.004
72446713|NCT04963270|144409786|SUPERIORITY|Stratified Analysis|Difference in Response Rate|-19.4||||0.005|TWO_SIDED|95.0|-32.8|-5.9|||Cochran-Mantel-Haenszel|||||-5.9|-32.8|0.005
72446714|NCT04963270|144409787|SUPERIORITY||Difference in Response Rate|-1.7||||0.847|TWO_SIDED|95.0|-19.4|15.9|||Cochran-Mantel-Haenszel|||||15.9|-19.4|0.847
72446715|NCT04963270|144409788|SUPERIORITY|Stratified Analysis|Difference in Response Rate|-4.3||||0.441|TWO_SIDED|95.0|-15.4|6.7|||Cochran-Mantel-Haenszel|||||6.7|-15.4|0.441
72446716|NCT04963270|144409789|SUPERIORITY||Difference in Response Rate|8.5||||0.115|TWO_SIDED|95.0|-2.1|19.0|||Cochran-Mantel-Haenszel|||||19|-2.1|0.115
72446717|NCT04963270|144409790|SUPERIORITY|Stratified Analysis|Difference in Response Rate|8.8||||0.077|TWO_SIDED|95.0|-1.0|18.6|||Cochran-Mantel-Haenszel|||||18.6|-1|0.077
72446718|NCT04963270|144409791|SUPERIORITY||Risk Difference|-6.77||||0.1314|TWO_SIDED|95.0|-17.25|3.7|||Cochran-Mantel-Haenszel|||||3.70|-17.25|0.1314
72446719|NCT04963270|144409792|SUPERIORITY|Stratified Analysis|Risk Difference|-5.07||||0.2264|TWO_SIDED|95.0|-14.74|4.61|||Cochran-Mantel-Haenszel|||||4.61|-14.74|0.2264
72446720|NCT04963270|144409793|SUPERIORITY||Difference in Adjusted Mean|3.44|STANDARD_ERROR_OF_MEAN|1.45||0.0179|TWO_SIDED|95.0|0.59|6.29|||ANCOVA and Conditional Mean Imputation|||||6.29|0.59|0.0179
72446721|NCT04963270|144409794|SUPERIORITY|Stratified Analysis|Difference in Adjusted Mean|3.73|STANDARD_ERROR_OF_MEAN|1.37||0.0066|TWO_SIDED|95.0|1.04|6.42|||ANCOVA and Conditional Mean Imputation|||||6.42|1.04|0.0066
72446722|NCT04026555|144409804|SUPERIORITY||Risk Ratio (RR)|1.43|||<|0.001|TWO_SIDED|95.0|1.16|1.78|||Regression, Poisson|||IPTW Poisson regression was used to model the number of escalations per visit with an offset of the log transformed length of stay normalized per 1000 bed days. Treatment effect is expressed in terms of adjusted incidence rate ratio (IRR) per 1000 patient bed days.||1.78|1.16|< 0.001
72446723|NCT04026555|144409805|SUPERIORITY||Risk Ratio (RR)|1.74|||<|0.001|TWO_SIDED|95.0|1.39|2.18||Correction for multiple comparisons was performed on all key outcomes within the primary and secondary hypotheses, respectively, using the false discovery rate method (FDR).|Regression, Logistic|||IPTW log-binomial regres- sion models were used to model the secondary and ad hoc outcomes. Treatment effect is expressed as adjusted relative risk (RR).||2.18|1.39|<0.001
72446724|NCT04026555|144409808|SUPERIORITY||Risk Ratio (RR)|0.76||||0.045|TWO_SIDED|95.0|0.58|0.99||Correction for multiple comparisons was performed on all key outcomes within the primary and secondary hypotheses, respectively, using the false discovery rate method (FDR).|Regression, Logistic|||IPTW log-binomial regression models were used to model the secondary and ad hoc outcomes. Treatment effect is expressed as adjusted relative risk (RR).||0.99|0.58|0.045
72446725|NCT04026555|144409813|SUPERIORITY||Hazard Ratio (HR)|1.07||||0.14|TWO_SIDED|95.0|0.98|1.18|||Regression, Cox|||||1.18|0.98|0.14
72446726|NCT06321809|144409846|SUPERIORITY|||||||0.24|||||||Wilcoxon (Mann-Whitney)|A significance level of p\<0.05 was used for all analyses.||total scale score comparison||||0.24
72446727|NCT06321809|144409846|SUPERIORITY|||||||0.001|||||||Wilcoxon (Mann-Whitney)|A significance level of p\<0.05 was used for all analyses||total scale score comparison||||0.001
72446728|NCT06321809|144409846|SUPERIORITY|||||||0.03|||||||Wilcoxon (Mann-Whitney)|A significance level of p\<0.05 was used for all analyses||total scale score comparison||||0.03
72446729|NCT06321809|144409846|SUPERIORITY|||||||0.003|||||||Kruskal-Wallis|A significance level of p\<0.05 was used for all analyses||total scale score comparison||||0.003
72446730|NCT06321809|144409847|SUPERIORITY|||||||0.08|||||||Kruskal-Wallis|A significance level of p\<0.05 was used for all analyses||Weight comparison||||0.08
72446731|NCT06321809|144409848|SUPERIORITY|||||||0.13|||||||Kruskal-Wallis|A significance level of p\<0.05 was used for all analyses||BMI Comparison||||0.13
72446732|NCT06321809|144409849|SUPERIORITY|||||||0.63|||||||Kruskal-Wallis|A significance level of p\<0.05 was used for all analyses||Waist Circumference Comparison||||0.63
72446733|NCT06321809|144409850|SUPERIORITY|||||||0.89|||||||Kruskal-Wallis|A significance level of p\<0.05 was used for all analyses||LDL Cholesterol Comparison||||0.89
72446734|NCT01987895|144409869|NON_INFERIORITY|Non-inferiority of CCR for cadazolid versus vancomycin is demonstrated if the lower limit of the 95% confidence interval (CI) is above -10%.|Difference between 2 proportions|-1.4|||||TWO_SIDED|95.0|-7.2|4.3|||||CI for the difference between two proportions are estimated using the Wilson's score method|||4.3|-7.2|
72498000|NCT01375764|144526401|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-22.36|STANDARD_ERROR_OF_MEAN|3.31|<|0.001|TWO_SIDED|95.0|-28.92|-15.8||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group (3 evolocumab alone dose groups and the ezetimibe group) and the stratification factors.|Ezetimibe is the reference.|||-15.80|-28.92|<0.001
72561206|NCT04832971|144652945|SUPERIORITY||Differeence vs Placebo at week 24|-24.5|||<|0.0001|TWO_SIDED|95.0|-32.6|-16.5||Model includes treatment arm, study visit, randomization stratification factor (LDL-C at Screening \[≥100 mg/dL vs \<100 mg/dL\]),and baseline value as model terms. Model also includes treatment by visit and treatment by baseline as interaction terms.|Mixed Models Repeated Measures|||||-16.5|-32.6|<.0001
72446735|NCT01987895|144409869|NON_INFERIORITY|Non-inferiority of CCR for cadazolid versus vancomycin is demonstrated if the lower limit of the 95% confidence interval (CI) is above -10%.|Difference between 2 proportions|-2.4|||||TWO_SIDED|95.0|-8.1|3.2|||||CI for the difference between two proportions are estimated using the Wilson's score method|Sensitivity analysis with imputation for a single day with missing UBM data between one day before end-of-treatment (EOT) and 2 days after EOT||3.2|-8.1|
72446736|NCT01987895|144409870|NON_INFERIORITY|Non-inferiority of CCR for cadazolid versus vancomycin is demonstrated if the lower limit of the 95% confidence interval (CI) is above -10%.|Difference between 2 proportions|-4.1|||||TWO_SIDED|95.0|-9.2|1.0|||||CI for the difference between two proportions are estimated using the Wilson' score method|||1.0|-9.2|
72446737|NCT01987895|144409871|SUPERIORITY|Superiority of cadazolid versus vancomycin is demonstrated if the lower limit of the 95% confidence interval (CI) is above zero|Difference between 2 proportions|3.3|||||TWO_SIDED|95.0|-4.3|10.8|||||CI for the difference between two proportions are estimated using the Wilson's score method|||10.8|-4.3|
72446738|NCT01987895|144409872|SUPERIORITY||Hazard Ratio (HR)|0.96||||0.6016|TWO_SIDED|95.0|0.8|1.14||two-sided p-value (alpha 5%) based on log-rank test stratified by first occurrence / first recurrence and geographical region.|Log Rank|||||1.14|0.80|0.6016
72446739|NCT01987895|144409873|SUPERIORITY||Least Square Mean difference|0.002||||0.9814|TWO_SIDED|95.0|-0.2|0.2||Two-sided 5% alpha level was used|ANOVA|ANOVA for repeated measurements was fitted using all values from Day 1 (baseline) to Day 12.|The Least Square Means of the treatments differences for the changes from baseline at Day 3 were obtained using estimate statements|Comparison of the diarrhea domain scores||0.20|-0.20|0.9814
72446740|NCT01987895|144409873|SUPERIORITY||Least Square Mean difference|0.087||||0.2879|TWO_SIDED|95.0|-0.07|0.25||Two-sided 5% alpha level was used|ANOVA|ANOVA for repeated measurements was fitted using all values from Day 1 (baseline) to Day 12|The Least Square Means of the treatments differences for the changes from baseline at Day 3 were obtained using estimate statements|Comparison of the abdominal symptoms domain scores||0.25|-0.07|0.2879
72446741|NCT01987895|144409873|SUPERIORITY||Least Square Mean difference|0.05||||0.488|TWO_SIDED|95.0|-0.09|0.19||Two-sided 5% alpha level was used|ANOVA|ANOVA for repeated measurements was fitted using all values from Day 1 (baseline) to Day 12|The Least Square Means of the treatments differences for the changes from baseline at Day 3 were obtained using estimate statements|Comparison of the systemic / other symptoms domain scores||0.19|-0.09|0.4880
72561207|NCT00500318|144652961|SUPERIORITY_OR_OTHER||Least Square Mean|116.44|STANDARD_ERROR_OF_MEAN|40.113||0.0042|TWO_SIDED|95.0|37.28|195.61|||ANCOVA|||||195.610|37.280|0.0042
72561208|NCT02104817|144652996|SUPERIORITY||Hazard Ratio (HR)|0.99||||0.837|TWO_SIDED|95.0|0.9|1.09||The hypothesis is tested at the 5% level. A hierarchical test sequence is used to address the issue of multiple testing.|Regression, Cox|||||1.09|0.90|0.837
72446742|NCT01987895|144409874|OTHER||Difference between 2 proportions|-1.8|||||TWO_SIDED|95.0|-6.5|2.9|||||CI for the difference between two proportions are estimated using the Wilson's score method|Exploratory analysis||2.9|-6.5|
72446743|NCT01987895|144409875|OTHER||Difference between 2 proportions|-1.9|||||TWO_SIDED|95.0|-6.2|2.3|||||CI for the difference between two proportions are estimated using the Wilson's score method|Exploratory analysis||2.3|-6.2|
72446744|NCT01987895|144409876|OTHER||Difference between 2 proportions|3.7|||||TWO_SIDED|95.0|-3.4|10.7|||||CI for the difference between two proportions are estimated using the Wilson's score method|Exploratory analysis||10.7|-3.4|
72446745|NCT01987895|144409877|OTHER|Sensitivity analysis|Difference between 2 proportions|1.1|||||TWO_SIDED|95.0|-6.5|8.7|||||CI for the difference between two proportions are estimated using the Wilson's score method|||8.7|-6.5|
72446746|NCT05364671|144409879|SUPERIORITY|||||||0.0088||||||A priori threshold for statistical significance is set to 0.04|Chi-squared|||||||0.0088
72446747|NCT05364671|144409880|SUPERIORITY|||||||0.0025||||||A priori threshold for statistical significance is set to 0.005|Wilcoxon (Mann-Whitney)|||Mean differences (Raphamin vs. Placebo) were compared||||0.0025
72446748|NCT05364671|144409882|SUPERIORITY|||||||0.2607|||||||Wilcoxon (Mann-Whitney)|||Mean differences (Raphamin vs. Placebo) were compared||||0.2607
72446749|NCT05364671|144409883|SUPERIORITY|||||||0.7601|||||||Fisher Exact|||"This analysis applies to Day 6 row."||||0.7601
72446750|NCT05364671|144409883|SUPERIORITY|||||||0.7685|||||||Fisher Exact|||"This analysis applies to Day 10 row."||||0.7685
72446751|NCT05364671|144409884|SUPERIORITY|||||||0.052|||||||Fisher Exact|||||||0.052
72446752|NCT05364671|144409885|SUPERIORITY|||||||0.19|||||||Fisher Exact|||||||0.19
72446753|NCT05364671|144409886|SUPERIORITY|||||||0.54|||||||Fisher Exact|||||||0.54
72446754|NCT05364671|144409887|SUPERIORITY|||||||0.1|||||||Fisher Exact|||||||0.10
72446755|NCT05364671|144409888|SUPERIORITY|||||||0.92||||||"The p-value associated with treatment\*visit interaction of pulse rate (heart rate) from Visit 1 to 4 between Raphamin and Placebo treatment groups. Model includes treatment, visit and treatment\*visit interaction."|ANOVA|||||||0.92
72446756|NCT05364671|144409889|SUPERIORITY|||||||0.44||||||"The p-value associated with treatment\*visit interaction of respiration rate (breathing rate) from Visit 1 to 4 between Raphamin and Placebo treatment groups. Model includes treatment, visit and treatment\*visit interaction."|ANOVA|||||||0.44
72446757|NCT05364671|144409890|SUPERIORITY|||||||0.9||||||"The p-value associated with treatment\*visit interaction of SpO2 from Visit 1 to 4 between Raphamin and Placebo treatment groups. Model includes treatment, visit and treatment\*visit interaction."|ANOVA|||||||0.90
72446758|NCT05364671|144409891|SUPERIORITY|||||||0.3||||||"The p-value associated with treatment\*visit interaction of SBP from Visit 1 to 4 between Raphamin and Placebo treatment groups. Model includes treatment, visit and treatment\*visit interaction."|ANOVA|||||||0.30
72446759|NCT05364671|144409891|SUPERIORITY|||||||0.94||||||"The p-value associated with treatment\*visit interaction of DBP from Visit 1 to 4 between Raphamin and Placebo treatment groups. Model includes treatment, visit and treatment\*visit interaction."|ANOVA|||||||0.94
72446760|NCT05256017|144409893|OTHER||Excess rate (ER)|-1.5|||||TWO_SIDED|95.0|-7.2|3.7||||||||3.7|-7.2|
72561209|NCT02104817|144652997|SUPERIORITY||Hazard Ratio (HR)|0.94||||0.269|TWO_SIDED|95.0|0.84|1.05||The hypothesis is tested at the 5% level. A hierarchical test sequence is used to address the issue of multiple testing.|Regression, Cox|||||1.05|0.84|0.269
72446761|NCT05256017|144409894|OTHER||Excess rate (ER)|-0.9|||||TWO_SIDED|95.0|-4.1|1.4|||||"ER: calculated as occurrence rate of the TEAE in the acoziborole arm minus occurrence rate of the TEAE in the placebo arm.~CI: calculated using the Wilson score interval."|Occurrence and excess rate (95% CI) of any TEAEs (by PT, for PTs reported in ≥1% of participants in either arm) from the investigational product administration (Day 1) to the Month 4 follow-up visit.||1.4|-4.1|
72446762|NCT05256017|144409895|OTHER||Excess rate (ER)|0.4|||||TWO_SIDED|95.0|-1.6|1.6|||||"ER: calculated as occurrence rate of the TEAE in the acoziborole arm minus occurrence rate of the TEAE in the placebo arm.~CI: calculated using the Wilson score interval."|||1.6|-1.6|
72446763|NCT05256017|144409896|OTHER||Excess rate (ER)|-0.5|||||TWO_SIDED|95.0|-3.2|1.4|||||"ER: calculated as occurrence rate of the TEAE in the acoziborole arm minus occurrence rate of the TEAE in the placebo arm.~CI: calculated using the Wilson score interval."|||1.4|-3.2|
72446764|NCT05256017|144409897|OTHER||Excess rate (ER)|-0.6|||||TWO_SIDED|95.0|-2.6|0.6|||||"ER: calculated as occurrence rate of the TEAE in the acoziborole arm minus occurrence rate of the TEAE in the placebo arm.~CI: calculated using the Wilson score interval."|||0.6|-2.6|
72446765|NCT05256017|144409898|OTHER||Excess rate (ER)|-0.2|||||TWO_SIDED|95.0|-2.2|0.8|||||"ER: calculated as occurrence rate of the TEAE in the acoziborole arm minus occurrence rate of the TEAE in the placebo arm.~CI: calculated using the Wilson score interval."|||0.8|-2.2|
72446766|NCT05256017|144409899|OTHER||Excess rate (ER)|-0.3|||||TWO_SIDED|95.0|-2.3|0.7|||||"ER: calculated as occurrence rate of the TEAE in the acoziborole arm minus occurrence rate of the TEAE in the placebo arm.~CI: calculated using the Wilson score interval."|||0.7|-2.3|
72446767|NCT05256017|144409900|OTHER||Excess rate (ER)|3.2|||||TWO_SIDED|95.0|0.3|5.3|||||"ER: calculated as occurrence rate of the TEAE in the acoziborole arm minus occurrence rate of the TEAE in the placebo arm.~CI: calculated using the Wilson score interval."|||5.3|0.3|
72561210|NCT02104817|144652998|SUPERIORITY||Hazard Ratio (HR)|1.05||||0.402|TWO_SIDED|95.0|0.93|1.19||The hypothesis is tested at the 5% level. A hierarchical test sequence is used to address the issue of multiple testing|Regression, Cox|||||1.19|0.93|0.402
72561211|NCT02104817|144652999|SUPERIORITY||Hazard Ratio (HR)|1.01||||0.94|TWO_SIDED|95.0|0.87|1.16||The hypothesis is tested at the 5% level. A hierarchical test sequence is used to address the issue of multiple testing|Regression, Cox|||||1.16|0.87|0.940
72446768|NCT05256017|144409901|OTHER||Excess rate (ER)|-0.1|||||TWO_SIDED|95.0|-2.4|1.3|||||"ER: calculated as occurrence rate of the TEAE in the acoziborole arm minus occurrence rate of the TEAE in the placebo arm.~CI: calculated using the Wilson score interval."|||1.3|-2.4|
72446769|NCT05256017|144409902|OTHER||Excess rate (ER)|-1.1|||||TWO_SIDED|95.0|-3.5|0.3|||||"ER: calculated as occurrence rate of the TEAE in the acoziborole arm minus occurrence rate of the TEAE in the placebo arm.~CI: calculated using the Wilson score interval."|||0.3|-3.5|
72446770|NCT05256017|144409903|OTHER||Excess rate (ER)|1.0|||||TWO_SIDED|95.0|-3.7|5.1||||||Occurrence and excess rate (95% CI) of any TEAEs reported during hospitalization.||5.1|-3.7|
72446771|NCT05256017|144409903|OTHER||Excess rate (ER)|-3.3|||||TWO_SIDED|95.0|-8.2|0.9||||||Occurrence and excess rate (95% CI) of any TEAEs reported after the hospitalization period.||0.9|-8.2|
72446772|NCT05256017|144409904|OTHER||Excess rate (ER)|-1.0|||||TWO_SIDED|95.0|-3.1|0.0||||||||0.0|-3.1|
72446773|NCT05256017|144409905|OTHER||Excess rate (ER)|-1.5|||||TWO_SIDED|95.0|-7.2|3.7||||||Of note, all AEs reported during this study were TEAEs.||3.7|-7.2|
72446774|NCT05256017|144409923|OTHER||Placebo-corrected change from baseline|-0.4|||||TWO_SIDED|90.0|-2.1|1.4||||||Placebo-corrected change from baseline (ΔΔ), calculated using an ANCOVA model adjusted for sex and age.||1.4|-2.1|
72446775|NCT05256017|144409924|OTHER||Placebo-corrected change from baseline|-0.5|||||TWO_SIDED|90.0|-22.0|21.1||||||Placebo-corrected change from baseline (ΔΔ), calculated using an ANCOVA model adjusted for sex and age.||21.1|-22.0|
72446776|NCT05256017|144409925|OTHER||Placebo-corrected change from baseline|-1.1|||||TWO_SIDED|90.0|-3.6|1.3||||||Placebo-corrected change from baseline (ΔΔ), calculated using an ANCOVA model adjusted for sex and age.||1.3|-3.6|
72446777|NCT05256017|144409926|OTHER||Placebo-corrected change from baseline|-0.7|||||TWO_SIDED|90.0|-1.9|0.4||||||Placebo-corrected change from baseline (ΔΔ), calculated using an ANCOVA model adjusted for sex and age.||0.4|-1.9|
72446778|NCT05256017|144409927|OTHER||Placebo-corrected change from baseline|-10.9|||||TWO_SIDED|90.0|-15.3|-6.6||||||Placebo-corrected change from baseline (ΔΔ), calculated using an ANCOVA model adjusted for sex and age.||-6.6|-15.3|
72446779|NCT05256017|144409928|OTHER||Placebo-corrected change from baseline|-11.5|||||TWO_SIDED|90.0|-14.4|-8.7||||||Placebo-corrected change from baseline (ΔΔ), calculated using an ANCOVA model adjusted for sex and age.||-8.7|-14.4|
72446780|NCT05256017|144409929|OTHER||Placebo-corrected change from baseline|-11.7|||||TWO_SIDED|90.0|-14.9|-8.6||||||Placebo-corrected change from baseline (ΔΔ), calculated using an ANCOVA model adjusted for sex and age.||-8.6|-14.9|
72498001|NCT01375764|144526402|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-37.92|STANDARD_ERROR_OF_MEAN|2.92|<|0.001|TWO_SIDED|95.0|-43.77|-32.07||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group (evolocumab + ezetimibe and ezetimibe alone) and the stratification factors.|Ezetimibe is the reference.|||-32.07|-43.77|<0.001
72498002|NCT01375764|144526403|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-34.05|STANDARD_ERROR_OF_MEAN|3.3|<|0.001|TWO_SIDED|95.0|-40.57|-27.52||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group (3 evolocumab alone dose groups and the ezetimibe group) and the stratification factors.|Ezetimibe is the reference.|||-27.52|-40.57|<0.001
72498003|NCT01375764|144526403|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-26.81|STANDARD_ERROR_OF_MEAN|3.3|<|0.001|TWO_SIDED|95.0|-33.35|-20.27||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group (3 evolocumab alone dose groups and the ezetimibe group) and the stratification factors.|Ezetimibe is the reference.|||-20.27|-33.35|<0.001
72498004|NCT01375764|144526403|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-25.1|STANDARD_ERROR_OF_MEAN|3.27|<|0.001|TWO_SIDED|95.0|-31.57|-18.62||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group (3 evolocumab alone dose groups and the ezetimibe group) and the stratification factors.|Ezetimibe is the reference.|||-18.62|-31.57|<0.001
72498005|NCT01375764|144526404|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-41.25|STANDARD_ERROR_OF_MEAN|2.87|<|0.001|TWO_SIDED|95.0|-46.99|-35.5||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group (evolocumab + ezetimibe and ezetimibe alone) and the stratification factors.|Ezetimibe is the reference.|||-35.50|-46.99|<0.001
72498006|NCT01194440|144526412|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Bonferonni|Adjusting for multiple comparisons in the analyses, a Bonferonni-corrected p-value of 0.05/5 = 0.01 to represent statistical significance was used.||The primary hypothesis of the study is that administration of zoledronic acid with letrozole would result in a significant decline in the percentage of women experiencing AIMSS compared to letrozole treatment alone (historical control).||||<0.001
72498007|NCT00896532|144526419|SUPERIORITY||LS Mean Difference from Placebo|8.7|||<|0.0001|TWO_SIDED|95.0|7.5|9.9||P-value is adjusted by the Hochberg procedure for comparisons to placebo.|Linear Mixed Effects Model|||A linear mixed effects model was fit with the percent change from baseline to months 3, 6 and 12 in BMD of the lumbar spine as the dependent variable and baseline BMD, machine type, interaction of baseline BMD and machine type, geographic region (Latin America, North America, Europe), visit, treatment regimen (categorical), interaction of treatment regimen and visit as the independent variables.||9.9|7.5|< 0.0001
72561212|NCT02104817|144653000|SUPERIORITY||Hazard Ratio (HR)|0.91||||0.092|TWO_SIDED|95.0|0.81|1.02||The hypothesis is tested at the 5% level. A hierarchical test sequence is used to address the issue of multiple testing|Regression, Cox|||||1.02|0.81|0.092
72561213|NCT02104817|144653001|SUPERIORITY||Hazard Ratio (HR)|0.85||||0.016|TWO_SIDED|95.0|0.75|0.97||The hypothesis is tested at the 5% level. A hierarchical test sequence is used to address the issue of multiple testing.|Regression, Cox|||||0.97|0.75|0.016
72561214|NCT02104817|144653002|SUPERIORITY||Hazard Ratio (HR)|1.09||||0.372|TWO_SIDED|95.0|0.9|1.31||The hypothesis is tested at the 5% level. A hierarchical test sequence is used to address the issue of multiple testing|Regression, Cox|||||1.31|0.90|0.372
72561215|NCT02104817|144653003|SUPERIORITY||Hazard Ratio (HR)|1.12||||0.336|TWO_SIDED|95.0|0.89|1.41||The hypothesis is tested at the 5% level. A hierarchical test sequence is used to address the issue of multiple testing.|Regression, Cox|||||1.41|0.89|0.336
72498008|NCT00896532|144526419|SUPERIORITY||LS Mean Difference from placebo|5.6|||<|0.0001|TWO_SIDED|95.0|4.3|6.9||P-value is adjusted by the Hochberg procedure for comparisons to placebo.|Linear Mixed Effects Model|||A linear mixed effects model was fit with the percent change from baseline to months 3, 6 and 12 in BMD of the lumbar spine as the dependent variable and baseline BMD, machine type, interaction of baseline BMD and machine type, geographic region (Latin America, North America, Europe), visit, treatment regimen (categorical), interaction of treatment regimen and visit as the independent variables.||6.9|4.3|< 0.0001
72498009|NCT00896532|144526419|SUPERIORITY||LS Mean Difference from Placebo|7.4|||<|0.0001|TWO_SIDED|95.0|6.1|8.7||P-value is adjusted by the Hochberg procedure for comparisons to placebo.|Linear Mixed Effects Model|||A linear mixed effects model was fit with the percent change from baseline to months 3, 6 and 12 in BMD of the lumbar spine as the dependent variable and baseline BMD, machine type, interaction of baseline BMD and machine type, geographic region (Latin America, North America, Europe), visit, treatment regimen (categorical), interaction of treatment regimen and visit as the independent variables.||8.7|6.1|< 0.0001
72498010|NCT00896532|144526419|SUPERIORITY||LS Mean Difference from Placebo|8.5|||<|0.0001|TWO_SIDED|95.0|7.3|9.8||P-value is adjusted by the Hochberg procedure for comparisons to placebo.|Linear Mixed Effects Model|||A linear mixed effects model was fit with the percent change from baseline to months 3, 6 and 12 in BMD of the lumbar spine as the dependent variable and baseline BMD, machine type, interaction of baseline BMD and machine type, geographic region (Latin America, North America, Europe), visit, treatment regimen (categorical), interaction of treatment regimen and visit as the independent variables.||9.8|7.3|< 0.0001
72498011|NCT02149810|144526430|SUPERIORITY||Mean Difference (Net)|0.109||||0.28|TWO_SIDED|95.0|-0.09|0.31||The a priori threshold for statistical significance was p = 0.05.|Mixed Models Analysis|Linear mixed models, controlling for baseline score, were used to compare the SSM and TAU groups' change score from baseline to 12-week on SDNN.||The primary focus of this study was the interaction effect of treatment on heart rate variability at Weeks 0 and 12. On the assumption that this effect size is medium (Cohen's f = .25), calculations (using G\*Power) 23 indicate that a sample size of 80 yield power estimates of .99 for both the interaction and the main effect of time. The study enrolled 95 participants to account for participant attrition.||0.31|-0.09|0.28
72561216|NCT02104817|144653004|SUPERIORITY||Hazard Ratio (HR)|1.13||||0.112|TWO_SIDED|95.0|0.97|1.31||The hypothesis is tested at the 5% level. A hierarchical test sequence is used to address the issue of multiple testing.|Regression, Cox|||||1.31|0.97|0.112
72561217|NCT02104817|144653005|SUPERIORITY||Hazard Ratio (HR)|1.18||||0.091|TWO_SIDED|95.0|0.97|1.42||The hypothesis is tested at the 5% level. A hierarchical test sequence is used to address the issue of multiple testing.|Regression, Cox|||||1.42|0.97|0.091
72561218|NCT02104817|144653006|SUPERIORITY||Hazard Ratio (HR)|0.94||||0.408|TWO_SIDED|95.0|0.83|1.08||This endpoint was not in the testing sequence and therefore not under type I error control.|Regression, Cox|||||1.08|0.83|0.408
72446781|NCT05256017|144409930|OTHER||Estimate|-10.7|STANDARD_DEVIATION|1.72|||TWO_SIDED|90.0|-13.5|-7.85||||||Estimated ΔΔQTcF (in ms) computed from a concentration-response (C-R) model between dry blood spot concentration of acoziborole and changes from baseline in QTcF parameter||-7.85|-13.5|
72446782|NCT03536754|144409948|SUPERIORITY||LSM Ratio|1.23|STANDARD_ERROR_OF_MEAN|1.171||0.1924|TWO_SIDED|90.0|0.95|1.6||≤ 0.1924|Mixed effects model for repeated measure|||||1.6|0.95|0.1924
72446783|NCT03536754|144409948|SUPERIORITY||LSM Ratio|1.35|STANDARD_ERROR_OF_MEAN|1.172||0.0612|TWO_SIDED|90.0|1.04|1.76||≤ 0.0612|Mixed effects model for repeated measure|||||1.76|1.04|0.0612
72446784|NCT03536754|144409948|SUPERIORITY||LSM Ratio|1.05|STANDARD_ERROR_OF_MEAN|1.169||0.7653|TWO_SIDED|90.0|0.81|1.36||≤ 0.7653|Mixed effects model for repeated measure|||||1.36|0.81|0.7653
72446785|NCT03536754|144409948|SUPERIORITY||LSM Ratio|1.2|STANDARD_ERROR_OF_MEAN|1.136||0.1537|TWO_SIDED|90.0|0.97|1.48||≤ 0.1537|Mixed effects model for repeated measure|||||1.48|0.97|0.1537
72446786|NCT03097549|144410040|SUPERIORITY||Estimated difference|-3.1||||0.001|TWO_SIDED|95.0|-4.8|-1.3|||Mixed Models Analysis|||Comparison of mean scores using a linear mixed model, incorporating baseline data and accounting for all available data. Sample size calculation: We anticipated ICIQ-UI SF improvements of 2.5 points in the treatment group and 0.9 points in the information group. Detecting this difference with 80% power, a two-sided test, and a significance level of P\<.05 would require a sample size of 49 in each group. With an expected drop-out rate of 20%, we needed approximately 60 participants in each group.||-1.3|-4.8|0.001
72446787|NCT03097549|144410041|SUPERIORITY||Estimated difference|-6.3||||0.004|TWO_SIDED|95.0|-10.5|-2.1|||Mixed Models Analysis|||Null hypothesis: There is no difference in score between the treatment group and the information group at follow-up.||-2.1|-10.5|0.004
72446788|NCT03097549|144410042|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||"Null hypothesis: There is no difference in the number of urinary leakage episodes between the treatment app users and the information app users at follow-up.~ITT analysis. Missing data: 5 participants in the treatment group and 2 participants in the information group had a missing value at follow-up, and for those, the difference was set to 0 (ie, no change)."||||<0.001
72446789|NCT03097549|144410043|SUPERIORITY||Estimated difference|-1.8|||<|0.001|TWO_SIDED|95.0|-2.8|-0.9|||Mixed Models Analysis|||Null hypothesis: There is no difference in score between the treatment group and the information group at follow-up.||-0.9|-2.8|<0.001
72446790|NCT03097549|144410044|SUPERIORITY||Estimated difference|-1.6||||0.016|TWO_SIDED|95.0|-2.8|-0.3|||Mixed Models Analysis|||Null hypothesis: There is no difference in score between the treatment group and the information group at follow-up.||-0.3|-2.8|0.016
72446791|NCT03097549|144410045|SUPERIORITY|||||||0.01|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: no difference in usage between treatment group and information group at follow-up.||||0.01
72446792|NCT03097549|144410046|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: No difference in improvement between the treatment group and the information group att follow-up.||||<0.001
72446793|NCT04282148|144410060|SUPERIORITY||||||<|0.0001|||||||Z test using Kaplan Meier survival estim|||||||<0.0001
72446794|NCT02683447|144410074|OTHER|Correlation||||||0.039||||||P \< 0.05 is considered statistically significant.|Pearson correlation|||||||0.039
72446795|NCT02683447|144410075|OTHER|Correlation|||||<|0.01||||||P \< 0.05 is considered statically significant.|Pearson correlation|||ACLS correct score||||<0.01
72446796|NCT02683447|144410075|OTHER|Correlation||||||0.322||||||P \< 0.05 is considered statically significant.|Pearson correlation|||ACLS risk score||||0.322
72446797|NCT03115476|144410089|OTHER||Hazard Ratio (HR)|1.43||||0.43|TWO_SIDED|95.0|0.61|3.9|||likelihood ratio test|||Relative difference between groups (ingenol disoxate vs vehicle) expressed as hazard ratio||3.9|0.61|0.43
72446798|NCT03115476|144410090|OTHER||Hazard Ratio (HR)|1.99|||<|0.01|TWO_SIDED|95.0|1.17|3.62|||likelihood ratio test|||relative difference between treatment groups (ingenol disoxate gel vs vehicle) expressed as hazard ratio||3.62|1.17|<0.01
72446799|NCT00613106|144410103|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4228||95.0|||||Cochran-Mantel-Haenszel|||||||0.4228
72446800|NCT02876588|144410177|SUPERIORITY||Odds Ratio (OR)|1.03||||0.6|TWO_SIDED|95.0|0.9|1.2||Random-effects logistic regression models were constructed, using RAR order sessions as the outcome, randomization group as the independent variable, and the clinician as the random intercept to account for nesting of order sessions within clinicians|Regression, Logistic|||||1.20|.90|.60
72446801|NCT02876588|144410178|SUPERIORITY||Odds Ratio (OR)|1.03||||0.68|TWO_SIDED|95.0|0.89|1.19||Random-effects logistic regression models were constructed, using RAR order sessions as the outcome, randomization group as the independent variable, the clinician as the random intercept to account for nesting of order sessions within clinicians|Regression, Logistic|||||1.19|.89|.68
72446802|NCT02876588|144410179|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
72446803|NCT02143726|144410211|SUPERIORITY||Hazard Ratio (HR)|0.56||||0.0918|TWO_SIDED|95.0|0.23|1.33|||Log Rank|Stratified 1-sided log-rank test (stratified by ECOG performance status, prior systemic treatment for hürthle thyroid cancer, and treating site).||||1.33|0.23|0.0918
72446804|NCT02143726|144410213|SUPERIORITY||Hazard Ratio (HR)|1.62||||0.3976|TWO_SIDED|95.0|0.53|4.96|||Log Rank|||||4.96|0.53|0.3976
72446805|NCT03953508|144410367|OTHER|Analysis of covariance test|||||>|0.05||||||Threshold for significance is p\<.05|ANCOVA|||||||>.05
72446806|NCT03953508|144410368|OTHER|T-test comparing differences, the null hypothesis is that the groups are equal|||||>|0.05||||||Threshold for significance is p\<.05|t-test, 2 sided|||||||>.05
72446807|NCT03953508|144410369|OTHER|Analysis of variance test comparing average breakpoint for menthol and non-menthol smokers|||||<|0.05||||||Threshold for significance is p\<.05|ANOVA|||||||<.05
72446808|NCT03953508|144410370|OTHER|T-test|||||<|0.05||||||Threshold for significance is p\<.05|t-test, 2 sided|||||||<.05
72446809|NCT03953508|144410371|OTHER|Analysis of variance|||||>|0.05||||||Threshold for significance is p\<.05|ANOVA|||||||>.05
72446810|NCT03953508|144410372|OTHER|Analysis of variance|||||<|0.05||||||Threshold for significance is p\<.05|ANOVA|||||||<.05
72446811|NCT03953508|144410373|OTHER|T-test|||||<|0.05||||||Threshold for significance is p\<.05|t-test, 2 sided|||||||<.05
72446812|NCT03953508|144410374|OTHER|Fisher's exact test|||||>|0.05||||||Threshold for significance is p\<.05|Fisher Exact|||||||>.05
72446813|NCT03953508|144410375|OTHER|T-test|||||>|0.05||||||Threshold for significance is p\<.05|t-test, 2 sided|||||||>.05
72498012|NCT02149810|144526431|SUPERIORITY||Mean Difference (Net)|0.034||||0.89|TWO_SIDED|95.0|-0.44|0.51||The a priori threshold for statistical significance was set at p = 0.05.|Mixed Models Analysis|Linear mixed models, controlling for baseline score, were used to compare the SSM and TAU groups' change score from baseline to 12-week on LF HRV.||||0.51|-0.44|0.89
72498013|NCT02149810|144526432|SUPERIORITY||Mean Difference (Net)|-2.66||||0.03|TWO_SIDED|95.0|-5.05|-0.26||The a priori threshold for statistical significance was set at p = 0.05.|Mixed Models Analysis|||||-0.26|-5.05|0.030
72498014|NCT02149810|144526433|SUPERIORITY||Mean Difference (Net)|-2.37||||0.021|TWO_SIDED|95.0|-4.37|-0.36||The a priori threshold for statistical significance was set at p = 0.05.|Mixed Models Analysis|||||-0.36|-4.37|0.021
72498015|NCT02149810|144526434|SUPERIORITY||Mean Difference (Net)|11.0||||0.22|TWO_SIDED|95.0|-7.01|29.01||The a priori threshold for statistical significance was set at p = 0.05.|Mixed Models Analysis|||||29.01|-7.01|0.22
72498016|NCT02149810|144526435|SUPERIORITY||Mean Difference (Net)|1.91||||0.72|TWO_SIDED|95.0|-8.54|12.37||The a priori threshold for statistical significance was set at p = 0.05.|Mixed Models Analysis|||||12.37|-8.54|0.72
72498017|NCT02149810|144526436|SUPERIORITY||Mean Difference (Net)|-0.8||||0.018|TWO_SIDED|95.0|-1.46|-0.15||The a priori threshold for statistical significance was set at p = 0.05.|Mixed Models Analysis|||||-0.15|-1.46|0.018
72498018|NCT02149810|144526437|SUPERIORITY||Mean Difference (Net)|-0.14||||0.99|TWO_SIDED|95.0|-21.94|21.66||The a priori threshold for statistical significance was set at p = 0.05.|Mixed Models Analysis|||||21.66|-21.94|0.99
72561219|NCT02104817|144653007|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.233|TWO_SIDED|95.0|0.63|1.12||This endpoint was not in the testing sequence and therefore not under type I error control.|Regression, Cox|||||1.12|0.63|0.233
72561220|NCT02104817|144653008|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.77|TWO_SIDED|95.0|0.81|1.17||This endpoint was not in the testing sequence and therefore not under type I error control.|Regression, Cox|||||1.17|0.81|0.770
72561221|NCT02104817|144653009|SUPERIORITY||Hazard Ratio (HR)|1.14||||0.278|TWO_SIDED|95.0|0.9|1.45||This endpoint was not in the testing sequence and therefore not under type I error control.|Regression, Cox|||||1.45|0.90|0.278
72561222|NCT01225055|144653010|SUPERIORITY|||||||0.84||||||calculated p-value indicating the effect of different treatment groups|ANOVA|Repeated measures ANOVA||||||0.84
72561223|NCT01225055|144653010|SUPERIORITY|||||||0.64||||||calculated p-value indicating the effect of different time points|ANOVA|Repeated measures ANOVA||||||0.64
72446814|NCT03953508|144410376|OTHER|T-test|||||>|0.05||||||Threshold for significance is p\<.05|t-test, 2 sided|||||||>.05
72498019|NCT02149810|144526438|SUPERIORITY||Odds Ratio (OR)|3.26||||0.049|TWO_SIDED|95.0|1.01|10.53||The a priori threshold for statistical significance was set at p = 0.05.|Regression, Linear|||Generalised linear models were used to compare the proportion of participants who responded to the intervention (≥50% decrease from baseline on the HRSD, defined a priori) at the end of intervention (week 12).||10.53|1.01|0.049
72498020|NCT02149810|144526439|SUPERIORITY||Odds Ratio (OR)|3.36||||0.04|TWO_SIDED|95.0|1.06|10.64||The a priori threshold for statistical significance was set at p = 0.05.|Regression, Linear|||Generalised linear models were used to compare the proportion of the proportion of participants who achieved remission (scores ≤7 on the HRSD, defined a priori) at the end of intervention (week 12).||10.64|1.06|0.040
72561224|NCT01225055|144653010|SUPERIORITY|||||||0.26||||||calculated p-value indicating the effect of different treatment groups and time points|ANOVA|Repeated measures ANOVA||||||0.26
72561225|NCT01225055|144653011|SUPERIORITY|||||||0.64||||||calculated p-value indicating the effect of different treatment groups|ANOVA|Repeated measures ANOVA||||||0.64
72446815|NCT04856163|144410380|SUPERIORITY|||||||0.08|||||||Regression, Logistic|||||||0.08
72561226|NCT01225055|144653011|SUPERIORITY|||||||0||||||calculated p-value indicating the effect of different time points|ANOVA|Repeated measures ANOVA||||||0.00
72561227|NCT01225055|144653011|SUPERIORITY|||||||0.09||||||calculated p-value indicating the effect of different treatment groups and time points|ANOVA|Repeated measures ANOVA||||||0.09
72561228|NCT01225055|144653012|SUPERIORITY|||||||0.72||||||calculated p-value indicating the effect of different treatment groups|ANOVA|Repeated measures ANOVA||||||0.72
72561229|NCT01225055|144653012|SUPERIORITY|||||||0.58||||||calculated p-value indicating the effect of different time points|ANOVA|Repeated measures ANOVA||||||0.58
72561230|NCT01225055|144653012|SUPERIORITY|||||||0.44||||||calculated p-value indicating the effect of different treatment groups and time points|ANOVA|Repeated measures ANOVA||||||0.44
72446816|NCT04856163|144410381|SUPERIORITY|||||||0.21|||||||discrete-time survival model|||||||0.21
72446817|NCT04856163|144410382|SUPERIORITY|||||||0.28|||||||Regression, Logistic|||||||0.28
72446818|NCT04856163|144410383|SUPERIORITY|||||||0.05|||||||Regression, Linear|||||||0.05
72446819|NCT03897465|144410440|NON_INFERIORITY|Pre-specified non-inferiority margin was 10%|Risk Difference (RD)|1.4|||||TWO_SIDED|95.0|-10.0||Upper Limit= +Infinity|||||Descriptive analysis of the primary endpoint was provided on per protocol population. The overall difference LomatuellPro (LP) - UrgoTul (UT) of the % of patients meeting main efficacy criterion was calculated with 95% bilateral confidence interval (CI). If lower limit of the 95% CI did not exceed the -10% value of pre-specified non-inferiority margin, non-inferiority had to be accepted. As a sensitivity analysis, the same analysis was performed on mITT (modified Intention-to-treat) population.|||-10|
72446820|NCT05119023|144410445|OTHER|||||||0.39||||||The threshold for statistical significance was p = 0.05|Pearson's correlation|||Examination of Language Severity and Characterization of learning: SRT Observational Learning Scores||||0.39
72446821|NCT05119023|144410445|OTHER||||||<|0.01||||||The threshold for statistical significance was p = 0.05|Pearson's correlation|||Examination of Language severity and Characterization of learning: AGL Observational Learning Scores||||<0.01
72446822|NCT05119023|144410445|OTHER|||||||0.95||||||The threshold for statistical significance was p = 0.05|Pearson's correlation|||Examination of Language severity and Characterization of learning: AGL Rule-based Learning Scores||||0.95
72446823|NCT05119023|144410446|OTHER|Sample underpowered for regression so correlation examined||||||0.36||||||The threshold for statistical significance was p = 0.05|Pearson's correlation|||Examination of Attention and Characterization of learning: SRT Observational Learning Scores||||0.36
72446824|NCT05119023|144410446|OTHER|||||||0.09|||||||Pearson's correlation|The threshold for statistical significance was p = 0.05||Examination of Attention and Characterization of learning: AGL Observational Learning Scores||||0.09
72498021|NCT03158220|144526450|NON_INFERIORITY|Non-inferiority of GMT in 27-45 year-olds relative to 16-26 year-olds was demonstrated if the lower limit of the 95% confidence interval (CI) for the fold difference was greater than 0.5.|Fold Difference|0.7|||<|0.001|TWO_SIDED|95.0|0.63|0.77||Analysis of variance (ANOVA) model with response of log individual titers and a fixed effect for age groups.|ANOVA||Fold difference calculated as GMT 27-45 year-olds/GMT 16-26 year-olds|Anti HPV 16||0.77|0.63|< 0.001
72498022|NCT03158220|144526450|NON_INFERIORITY|Non-inferiority of GMT in 27-45 year-olds relative to 16-26 year-olds was demonstrated if the lower limit of the 95% confidence interval (CI) for the fold difference was greater than 0.5.|Fold Difference|0.71|||<|0.001|TWO_SIDED|95.0|0.64|0.8||Analysis of variance (ANOVA) model with response of log individual titers and a fixed effect for age groups.|ANOVA||Fold difference calculated as GMT 27-45 year-olds/GMT 16-26 year-olds|Anti HPV 18||0.80|0.64|< 0.001
72498023|NCT03158220|144526450|NON_INFERIORITY|Non-inferiority of GMT in 27-45 year-olds relative to 16-26 year-olds was demonstrated if the lower limit of the 95% confidence interval (CI) for the fold difference was greater than 0.5.|Fold Difference|0.66|||<|0.001|TWO_SIDED|95.0|0.6|0.74||ANOVA model with response of log individual titers and a fixed effect for age groups.|ANOVA||Fold difference calculated as GMT 27-45 year-olds/GMT 16-26 year-olds|Anti HPV 31||0.74|0.60|< 0.001
72498024|NCT03158220|144526450|NON_INFERIORITY|Non-inferiority of GMT in 27-45 year-olds relative to 16-26 year-olds was demonstrated if the lower limit of the 95% confidence interval (CI) for the fold difference was greater than 0.5.|Fold Difference|0.73|||<|0.001|TWO_SIDED|95.0|0.67|0.8||ANOVA model with response of log individual titers and a fixed effect for age groups.|ANOVA||Fold difference calculated as GMT 27-45 year-olds/GMT 16-26 year-olds|Anti HPV 33||0.80|0.67|< 0.001
72498025|NCT03158220|144526450|NON_INFERIORITY|Non-inferiority of GMT in 27-45 year-olds relative to 16-26 year-olds was demonstrated if the lower limit of the 95% confidence interval (CI) for the fold difference was greater than 0.5.|Fold Difference|0.68|||<|0.001|TWO_SIDED|95.0|0.6|0.76||ANOVA model with response of log individual titers and a fixed effect for age groups.|ANOVA||Fold difference calculated as GMT 27-45 year-olds/GMT 16-26 year-olds|Anti HPV 45||0.76|0.60|< 0.001
72561231|NCT01225055|144653013|SUPERIORITY|||||||0.02||||||calculated p-value indicating the effect of different treatment groups|ANOVA|Repeated measures ANOVA||||||0.02
72561232|NCT01225055|144653013|SUPERIORITY|||||||0.1||||||calculated p-value indicating the effect of different time points|ANOVA|Repeated measures ANOVA||||||0.10
72561233|NCT01225055|144653013|SUPERIORITY|||||||0.04||||||calculated p-value indicating the effect of different treatment groups and time points|ANOVA|Repeated measures ANOVA||||||0.04
72561234|NCT01225055|144653014|SUPERIORITY|||||||0.01||||||calculated p-value indicating the effect of different treatment groups|ANOVA|Repeated measures ANOVA||||||0.01
72561235|NCT01225055|144653014|SUPERIORITY|||||||0.34||||||calculated p-value indicating the effect of different time points|ANOVA|Repeated measures ANOVA||||||0.34
72561236|NCT01225055|144653014|SUPERIORITY|||||||0.2||||||calculated p-value indicating the effect of different treatment groups and time points|ANOVA|Repeated measures ANOVA||||||0.20
72561237|NCT01225055|144653015|SUPERIORITY|||||||0||||||calculated p-value indicating the effect of different treatment groups|ANOVA|Repeated measures ANOVA||||||0.00
72561238|NCT01225055|144653015|SUPERIORITY|||||||0.01||||||calculated p-value indicating the effect of different time points|ANOVA|Repeated measures ANOVA||||||0.01
72561239|NCT01225055|144653015|SUPERIORITY|||||||0.04||||||calculated p-value indicating the effect of different treatment groups and time points|ANOVA|Repeated measures ANOVA||||||0.04
72561240|NCT04633642|144653036|SUPERIORITY||Mean Difference (Final Values)|1.05|STANDARD_DEVIATION|0.74|<|0.01|TWO_SIDED|||||The threshold for statistical significances was p\<0.05|Wilcoxon (Mann-Whitney)|||||||<0.01
72498026|NCT03158220|144526450|NON_INFERIORITY|Non-inferiority of GMT in 27-45 year-olds relative to 16-26 year-olds was demonstrated if the lower limit of the 95% confidence interval (CI) for the fold difference was greater than 0.5.|Fold Difference|0.71|||<|0.001|TWO_SIDED|95.0|0.64|0.78||ANOVA model with response of log individual titers and a fixed effect for age groups.|ANOVA||Fold difference calculated as GMT 27-45 year-olds/GMT 16-26 year-olds|Anti HPV 52||0.78|0.64|< 0.001
72498027|NCT03158220|144526450|NON_INFERIORITY|Non-inferiority of GMT in 27-45 year-olds relative to 16-26 year-olds was demonstrated if the lower limit of the 95% confidence interval (CI) for the fold difference was greater than 0.5.|Fold Difference|0.69|||<|0.001|TWO_SIDED|95.0|0.63|0.76||ANOVA model with response of log individual titers and a fixed effect for age groups.|ANOVA||Fold difference calculated as GMT 27-45 year-olds/GMT 16-26 year-olds|Anti HPV 58||0.76|0.63|< 0.001
72498028|NCT03158220|144526453|OTHER||Difference in Percentages|-2.5||||0.212|TWO_SIDED|95.0|-6.4|1.4|||Miettinen & Nurminen||Difference in percentages calculated as % Women 27-45 Years of Age minus % Women 16-26 Years of Age.|||1.4|-6.4|0.212
72498029|NCT03158220|144526454|OTHER||Difference in Percentages|-1.9|||||TWO_SIDED|95.0|-7.3|3.4|||||Difference in percentages calculated as % Women 27-45 Years of Age minus % Women 16-26 Years of Age.|||3.4|-7.3|
72561241|NCT04633642|144653037|SUPERIORITY||Mean Difference (Final Values)|1.61|STANDARD_DEVIATION|0.17|<|0.01|TWO_SIDED|||||The threshold for statistical significance was p\<0.05|Wilcoxon (Mann-Whitney)|||||||<0.01
72561242|NCT04633642|144653038|SUPERIORITY||Mean Difference (Final Values)|0.56|STANDARD_DEVIATION|0.79|<|0.01|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<0.01
72561243|NCT04633642|144653039|SUPERIORITY||Mean Difference (Final Values)|-2.28|STANDARD_DEVIATION|0.44||0.01|TWO_SIDED|||||The threshold for statistical significance was p\<0.05|t-test, 2 sided|||We analyzed 51 patients (24 in surgical group and 27 in UAW group) with a statistical power of 0.80 and an alpha of 0.05, with a power of the clinical di↵erence of 37% to detect a statistically significant between groups.||||0.01
72561244|NCT04633642|144653040|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.93|TWO_SIDED|||||The threshold for statistics significance was p\<0.05|t-test, 2 sided|||||||0.93
72561245|NCT04633642|144653041|SUPERIORITY||Mean Difference (Final Values)|0.02|STANDARD_DEVIATION|0.18||0.711|TWO_SIDED||||||t-test, 2 sided|||We analyzed 51 patients (24 in surgical group and 27 in UAW group) with a statistical power of 0.80 and an alpha of 0.05, with a power of the clinical difference of 37% to detect a statistically significant between groups.||||0.711
72561246|NCT03223909|144653068|NON_INFERIORITY|"it was considered as not inferior when the treatments did not present differences greater than 20%~Statistical analysis of groups in the baseline visit versus final visit"||||||0.08|||||||ANOVA|||||||0.080
72561247|NCT03223909|144653068|NON_INFERIORITY|"it was considered as not inferior when the treatments did not present differences greater than 20%~Statistical analysis between groups in the final visit"||||||0.848|||||||ANOVA|||||||0.848
72561248|NCT03223909|144653069|NON_INFERIORITY|it was considered as not inferior when the treatments did not present differences greater than 20%||||||0.468|||||||Chi-squared, Corrected|||||||0.468
72561249|NCT03223909|144653070|NON_INFERIORITY|population analysis was per protocol||||||0.0001|||||||ANOVA|||||||0.0001
72561250|NCT03223909|144653070|NON_INFERIORITY|population analysis was per protocol||||||0.65|||||||Wilcoxon (Mann-Whitney)|||||||0.650
72561251|NCT03223909|144653071|NON_INFERIORITY|"It was considered as not inferior when the treatments did not present differences greater than 20%~Statistical analysis of Humylub® Ofteno (PRO-087) versus Systane® Ultra PF at the final visit."||||||0.003|||||||ANOVA|||||||0.003
72561252|NCT03223909|144653071|NON_INFERIORITY|It was considered as not inferior when the treatments did not present differences greater than 20% Statistical analysis of Humylub® Ofteno (PRO-087) versus Systane® Ultra PF at the final visit.||||||0.003|||||||ANOVA|||||||0.003
72390244|NCT00042289|144288444|SUPERIORITY||Geometric mean of ratio|0.74||||0.0098|TWO_SIDED|90.0|0.61|0.89||2nd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||0.89|0.61|0.0098
72390245|NCT00042289|144288444|SUPERIORITY||Geometric mean of ratio|0.75||||0.0025|TWO_SIDED|90.0|0.64|0.88||3rd Trimester vs. Postpartum|Wilcoxon signed rank test|||||0.88|0.64|0.0025
72390246|NCT00042289|144288444|SUPERIORITY||Geometric mean of ratio|0.54|||<|0.0001|TWO_SIDED|90.0|0.46|0.64||3rd Trimester vs. Postpartum|Wilcoxon signed rank test|||||0.64|0.46|<0.0001
72390247|NCT00042289|144288444|SUPERIORITY||Geometric mean of ratio|0.56||||0.0024|TWO_SIDED|90.0|0.41|0.76||2nd Trimester vs. Postpartum|Wilcoxon signed rank test|||||0.76|0.41|0.0024
72390248|NCT00042289|144288444|SUPERIORITY||Geometric mean of ratio|0.795||||0.438|TWO_SIDED|90.0|0.499|1.269||2nd Trimester vs. Postpartum|Wilcoxon signed rank test|||||1.269|0.499|0.438
72390249|NCT00042289|144288444|SUPERIORITY||Geometric mean of ratio|0.531||||0.219|TWO_SIDED|90.0|0.186|1.512||3rd Trimester vs. Postpartum|Wilcoxon signed rank test|||||1.512|0.186|0.219
72390250|NCT00042289|144288444|SUPERIORITY||Geometric mean of ratio|1.05||||0.296|TWO_SIDED|90.0|0.94|1.18||2nd Trimester vs. Postpartum|Wilcoxon signed rank test|||||1.18|0.94|0.296
72390251|NCT00042289|144288444|SUPERIORITY||Geometric mean of ratio|1.26||||0.007|TWO_SIDED|90.0|1.01|1.56||3rd Trimester vs. Postpartum|Wilcoxon signed rank test|||||1.56|1.01|0.007
72390252|NCT00042289|144288444|SUPERIORITY||Geometric mean of ratio|0.83||||0.16|TWO_SIDED|90.0|0.56|1.22||2nd Trimester vs Postpartum|Wilcoxon signed rank test|||FPV was analyzed as the form of amprenavir (APV). FPV is the prodrug of APV.||1.22|0.56|0.16
72390253|NCT00042289|144288444|SUPERIORITY||Geometric mean of ratio|0.74||||0.03|TWO_SIDED|90.0|0.58|0.93|||Wilcoxson signed rank test|||FPV was analyzed in the form of amprenavir (APV). FPV is the prodrug of APV.||0.93|0.58|0.03
72390254|NCT00042289|144288444|SUPERIORITY||Geometric mean of ratio|0.86|||>|0.05|TWO_SIDED|90.0|0.68|1.08||3rd Trimester vs. Postpartum (No comparison was done for 2nd Trimester vs. Postpartum since the sample size for 2nd trimester was 1)|Wilcoxon signed rank test|||This analysis was for ATV.||1.08|0.68|>0.05
72390255|NCT00042289|144288444|SUPERIORITY||Geometric mean of ratio|0.89||||0.1636|TWO_SIDED|90.0|0.79|1.01||Third Trimester vs. Postpartum (No comparison was done for Second Trimester vs. Postpartum since only 4 participants had Second Trimester data)|Wilcoxon signed rank test|||||1.01|0.79|0.1636
72390256|NCT00042289|144288444|SUPERIORITY||Geometric mean of ratio|0.69|||<|0.05|TWO_SIDED|90.0|0.53|0.91||3rd Trimester vs Postpartum (No comparison was done for Second Trimester vs. Postpartum since only 4 participants had Second Trimester data)|Wilcoxon signed rank test|||This analysis was for ATV.||0.91|0.53|<0.05
72390257|NCT00042289|144288444|SUPERIORITY||Geometric mean of ratio|1.11||||0.16|TWO_SIDED|90.0|0.99|1.24||3rd Trimester vs. Postpartum (No comparison was done for Second Trimester vs. Postpartum since there was no Second Trimester data available)|Wilcoxon signed rank test|||||1.24|0.99|0.16
72390258|NCT00042289|144288444|SUPERIORITY||||||<|0.05||||||2nd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||||<0.05
72390259|NCT00042289|144288444|SUPERIORITY||||||<|0.05||||||3rd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||||<0.05
72390260|NCT00042289|144288444|SUPERIORITY||||||<|0.05||||||2nd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||||<0.05
72390261|NCT00042289|144288444|SUPERIORITY||||||<|0.05||||||3rd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||||<0.05
72390262|NCT00042289|144288444|SUPERIORITY||||||>|0.05||||||2nd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||||>0.05
72390263|NCT00042289|144288444|SUPERIORITY||||||>|0.05||||||3rd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||||>0.05
72390264|NCT00042289|144288444|SUPERIORITY||||||<|0.05||||||2nd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||||<0.05
72390265|NCT00042289|144288444|SUPERIORITY||||||<|0.05||||||3rd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||||<0.05
72390266|NCT00042289|144288444|SUPERIORITY||Geometric mean of ratio|1.06||||0.67|TWO_SIDED|90.0|0.85|1.34||3rd Trimester vs. Postpartum (No comparison was done for Second Trimester vs. Postpartum since only 2 participants had Second Trimester data)|Wilcoxon signed-rank test|||||1.34|0.85|0.67
72390267|NCT00042289|144288444|SUPERIORITY||Geometric mean of ratio|0.73||||0.08|TWO_SIDED|90.0|0.59|0.91||2nd Trimester vs. Postpartum|Wilcoxon signed rank test|||||0.91|0.59|0.08
72390268|NCT00042289|144288444|SUPERIORITY||Geometric mean of ratio|0.63|||<|0.01|TWO_SIDED|90.0|0.55|0.72||3rd Trimester vs. Postpartum|Wilcoxon signed rank test|||||0.72|0.55|<0.01
72390269|NCT00042289|144288445|SUPERIORITY||Geometric mean of ratio|0.57|||<|0.05|TWO_SIDED|90.0|0.48|0.68||2nd Trimester vs. Postpartum|Wilcoxon signed rank test|||||0.68|0.48|<0.05
72390270|NCT00042289|144288445|SUPERIORITY||Geometric mean of ratio|0.73|||<|0.05|TWO_SIDED|90.0|0.62|0.85||3rd Trimester vs.Postpartum|Wilcoxon signed rank test|||||0.85|0.62|<0.05
72390271|NCT00042289|144288445|SUPERIORITY|||||||0.09||||||2nd Trimester vs. Postpartum|Wilcoxon signed rank test|||||||0.09
72390272|NCT00042289|144288445|SUPERIORITY|||||||0.003||||||3rd Trimester vs. Postpartum|Wilcoxon signed rank test|||||||0.003
72390273|NCT00042289|144288445|SUPERIORITY||Geometric mean of ratio|1.34||||0.036|TWO_SIDED|||||3rd Trimester vs. Postpartum (No comparison was done for Second Trimester vs. Postpartum since only 5 participants had Second Trimester data)|Wilcoxon signed rank test|||||||0.036
72390274|NCT00042289|144288445|SUPERIORITY||Geometric mean of ratio|0.84|||>|0.05|TWO_SIDED|90.0|0.69|1.02||2nd Trimester vs. Postpartum|Wilcoxon signed rank test|||||1.02|0.69|>0.05
72390275|NCT00042289|144288445|SUPERIORITY||Geometric mean of ratio|0.83|||>|0.05|TWO_SIDED|90.0|0.68|1.01||3rd Trimester vs. Postpartum|Wilcoxon signed rank test|||||1.01|0.68|>0.05
72390276|NCT00042289|144288446|SUPERIORITY||Geometric mean of ratio|0.61||||0.14|TWO_SIDED|90.0|0.34|1.09||2nd Trimester vs. Postpartum|Wilcoxon signed rank test|||||1.09|0.34|0.14
72390277|NCT00042289|144288446|SUPERIORITY||Geometric mean of ratio|0.64||||0.002|TWO_SIDED|90.0|0.5|0.81||3rd Trimester vs. Postpartum|Wilcoxon signed rank test|||||0.81|0.50|0.002
72390278|NCT00042289|144288446|SUPERIORITY||Geometric mean of ratio|0.77||||0.24|TWO_SIDED|90.0|0.49|1.23||2nd Trimester vs. Postpartum|Wilcoxon signed rank test|||||1.23|0.49|0.24
72390279|NCT00042289|144288446|SUPERIORITY||Geometric mean of ratio|0.84||||0.53|TWO_SIDED|90.0|0.6|1.17||3rd Trimester vs. Postpartum|Wilcoxon signed rank test|||||1.17|0.60|0.53
72390280|NCT00042289|144288446|SUPERIORITY||Geometric mean of ratio|0.58||||0.2|TWO_SIDED|90.0|0.3|1.11||2nd Trimester vs. Postpartum|Wilcoxon signed rank test|||||1.11|0.30|0.2
72390281|NCT00042289|144288446|SUPERIORITY||Geometric mean of ratio|0.95||||0.12|TWO_SIDED|90.0|0.58|1.55||3rd Trimester vs. Postpartum|Wilcoxon signed rank test|||||1.55|0.58|0.12
72390282|NCT00042289|144288446|SUPERIORITY||Geometric mean of ratio|0.92||||0.358|TWO_SIDED|90.0|0.71|1.2||2nd Trimester vs. Postpartum|Wilcoxon signed rank test|||||1.2|0.71|0.358
72390283|NCT00042289|144288446|SUPERIORITY||Geometric mean of ratio|0.72||||0.0156|TWO_SIDED|90.0|0.55|0.93||3rd Trimester vs. Postpartum|Wilcoxon signed rank test|||||0.93|0.55|0.0156
72390284|NCT00042289|144288447|SUPERIORITY||Geometric mean of ratio|0.7||||0.007|TWO_SIDED|90.0|0.58|0.85||3rd Trimester vs. Postpartum (No comparison was done for Second Trimester vs. Postpartum since no Second Trimester data was available)|Wilcoxon signed rank test|||||0.85|0.58|0.007
72390285|NCT00042289|144288448|SUPERIORITY||Geometric mean ratio|0.66||||0.109|TWO_SIDED|90.0|0.39|1.12||2nd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||1.12|0.39|0.109
72390286|NCT00042289|144288448|SUPERIORITY||Geometric mean ratio|0.58|||<|0.001|TWO_SIDED|90.0|0.49|0.69||3rd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||0.69|0.49|<0.001
72390287|NCT00042289|144288448|SUPERIORITY||Geometric mean ratio|0.48||||0.44|TWO_SIDED|90.0|0.14|1.65||2nd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||1.65|0.14|0.44
72390288|NCT00042289|144288448|SUPERIORITY||Geometric mean ratio|0.56|||<|0.001|TWO_SIDED|90.0|0.43|0.72||3rd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||0.72|0.43|<0.001
72390289|NCT00042289|144288448|SUPERIORITY||Geometric mean ratio|0.83||||0.43|TWO_SIDED|90.0|0.63|1.1||2nd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||1.10|0.63|0.43
72390290|NCT00042289|144288448|SUPERIORITY||Geometric mean ratio|1.0||||0.31|TWO_SIDED|90.0|0.69|1.44||3rd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||1.44|0.69|0.31
72390291|NCT00042289|144288448|SUPERIORITY||Geometric mean ratio|0.9||||0.49|TWO_SIDED|90.0|0.71|1.16||3rd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||1.16|0.71|0.49
72390292|NCT00042289|144288449|SUPERIORITY||Geometric mean ratio|0.45|||<|0.05|TWO_SIDED|90.0|0.32|0.63||2nd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||0.63|0.32|<0.05
72390293|NCT00042289|144288449|SUPERIORITY||Geometric mean ratio|0.72|||<|0.05|TWO_SIDED|90.0|0.58|0.88||3rd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||0.88|0.58|<0.05
72390294|NCT00042289|144288449|SUPERIORITY||Geometric mean ratio|0.42||||0.02|TWO_SIDED|90.0|0.23|0.78||2nd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||0.78|0.23|0.02
72390295|NCT00042289|144288449|SUPERIORITY||Geometric mean ratio|0.78||||0.3|TWO_SIDED|90.0|0.56|1.08||3rd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||1.08|0.56|0.3
72390296|NCT00042289|144288449|SUPERIORITY||Geometric mean ratio|1.41||||0.036|TWO_SIDED|||||3rd Trimester vs. Postpartum \[Note: Comparison of 2nd Trimester vs. Postpartum was not done due to low sample size.\]|Wilcoxon signed-rank test|||||||0.036
72390297|NCT00042289|144288449|SUPERIORITY||Geometric mean ratio|0.41|||<|0.05|TWO_SIDED|90.0|0.32|0.52||2nd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||0.52|0.32|<0.05
72390298|NCT00042289|144288449|SUPERIORITY||Geometric mean ratio|0.48|||<|0.05|TWO_SIDED|90.0|0.41|0.57||3rd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||0.57|0.41|<0.05
72390299|NCT00042289|144288450|SUPERIORITY||Geometric mean ratio|0.85||||0.1|TWO_SIDED|90.0|0.72|1.01||3rd Trimester vs. Postpartum|t-test, 2 sided|Paired sample t-test on natural log-transformed PK parameter||||1.01|0.72|0.10
72390300|NCT00042289|144288451|SUPERIORITY||Geometric mean ratio|0.49||||0.0039|TWO_SIDED|90.0|0.35|0.68||2nd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||0.68|0.35|0.0039
72390301|NCT00042289|144288451|SUPERIORITY||Geometric mean ratio|0.66||||0.0062|TWO_SIDED|90.0|0.52|0.84||3rd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||0.84|0.52|0.0062
72390302|NCT00042289|144288451|SUPERIORITY||||||<|0.1||||||2nd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||||<0.10
72390303|NCT00042289|144288451|SUPERIORITY||||||<|0.1||||||3rd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||||<0.10
72390304|NCT00042289|144288451|SUPERIORITY||Geometric mean ratio|0.15|||<|0.1|TWO_SIDED|90.0|0.08|0.3||2nd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||0.30|0.08|<0.10
72390305|NCT00042289|144288451|SUPERIORITY||Geometric mean ratio|0.21|||<|0.1|TWO_SIDED|90.0|0.12|0.36||3rd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||0.36|0.12|<0.10
72390306|NCT00042289|144288451|SUPERIORITY||Geometric mean ratio|0.32|||<|0.1|TWO_SIDED|90.0|0.2|0.51||2nd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||0.51|0.20|<0.10
72390307|NCT00042289|144288451|SUPERIORITY||Geometric mean ratio|0.32|||>|0.1|TWO_SIDED|90.0|0.11|0.94||3rd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||0.94|0.11|>0.10
72390308|NCT00042289|144288451|OTHER||Geometric mean ratio|0.87||||0.079|TWO_SIDED|90.0|0.78|0.97||2nd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||0.97|0.78|0.079
72390309|NCT00042289|144288451|SUPERIORITY||Geometric mean ratio|0.92||||0.01|TWO_SIDED|90.0|0.77|1.09||3rd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||1.09|0.77|0.01
72390310|NCT00042289|144288451|SUPERIORITY||Geometric mean ratio|0.51|||<|0.05|TWO_SIDED|90.0|0.37|0.72||3rd Trimester vs. Postpartum \[Note: Comparison of 2nd Trimester vs. Postpartum was not done due to low sample size.\]|Wilcoxon signed-rank test|||||0.72|0.37|<0.05
72498030|NCT03158220|144526455|OTHER||Difference in Percentages|-1.0||||0.3|TWO_SIDED|95.0|-3.1|0.9|||Miettinen & Nurminen||Difference in percentages calculated as % Women 27-45 Years of Age minus % Women 16-26 Years of Age.|||0.9|-3.1|0.300
72498031|NCT01015833|144526457|SUPERIORITY||Hazard Ratio (HR)|1.06||||0.24|TWO_SIDED|95.0|0.8|1.4|||t-test, 1 sided|||||1.4|0.8|0.24
72498032|NCT01015833|144526459|SUPERIORITY||Hazard Ratio (HR)|0.9||||0.98|TWO_SIDED|95.0|0.72|1.2|||t-test, 1 sided|||||1.2|0.72|0.98
72498033|NCT02730260|144526476|SUPERIORITY_OR_OTHER|||||||0.41|||||||Chi-squared|||Test of the null hypothesis that directive and nondirective coaching have equal smoking cessation rates.||||0.41
72498034|NCT02730260|144526476|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.8|||<|0.03|TWO_SIDED||||||Regression, Logistic|||Odds ratio based on the parameter estimate for the variable, IncomeAboveMedian (0=false, 1=true), from the logistic regression model representing the a priori hypothesis, which specified income, race, and intervention as independent and interacting variables, and smoking cessation at last contact as the dependent variable. An unbalanced variable, PriorQuit (0-=none in the past year, 1=at least one in the past year) was added to the a priori model.||||<0.03
72561253|NCT03223909|144653072|NON_INFERIORITY|"the statistical analysis was carried out by intention to treat~It was considered as not inferior when the treatments did not present differences greater than 20%"||||||0.93|||||||Chi-squared|||||||0.930
72561254|NCT03223909|144653073|NON_INFERIORITY|it was considered as not inferior when the treatments did not present differences greater than 20%||||||0.548|||||||ANOVA|||||||0.548
72561255|NCT03223909|144653074|NON_INFERIORITY|it was considered as not inferior when the treatments did not present differences greater than 20%||||||0.17|||||||ANOVA|||||||0.170
72561256|NCT03223909|144653075|NON_INFERIORITY|it was considered as not inferior when the treatments did not present differences greater than 20%||||||0.085|||||||Chi-squared, Corrected|||||||0.085
72561257|NCT01628549|144653079|SUPERIORITY||Difference in Least Squares Means|1.53||||0.4344|TWO_SIDED|95.0|-2.32|5.38|||ANCOVA|||||5.38|-2.32|0.4344
72561258|NCT01628549|144653079|SUPERIORITY||Difference in Least Squares Means|4.46||||0.0266|TWO_SIDED|95.0|0.52|8.4|||ANCOVA|||||8.40|0.52|0.0266
72561259|NCT01628549|144653079|SUPERIORITY||Difference in Least Squares Means|4.37||||0.0317|TWO_SIDED|95.0|0.39|8.36|||ANCOVA|||||8.36|0.39|0.0317
72561260|NCT01628549|144653080|SUPERIORITY||Difference vs placebo in success rate|3.4||||0.33|TWO_SIDED|95.0|-7.82|14.38|||Cochran-Mantel-Haenszel|||||14.38|-7.82|0.3300
72498035|NCT02730260|144526476|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.6|||<|0.03|TWO_SIDED||||||Regression, Logistic|||Odds ratio for PriorQuit, from the logistic regression model representing the a priori hypothesis, which specified income, race, and intervention as independent and interacting variables, and smoking cessation at last contact as the dependent variable. This variable, PriorQuit (0-=none in the past year, 1=at least one in the past year) was added to the a priori model because it was not balanced after randomization.||||<0.03
72498036|NCT05032950|144526506|OTHER||Reference/Test Ratio|368.33|||||TWO_SIDED|90.0|318.91|425.41|||Mixed Models Analysis|||Natural log-transformed Cmax of midazolam was analyzed using mixed effect model with treatment, period and sequence as fixed effects and participant in sequence as random effect. Estimates of the adjusted mean differences (AMD) (Test-Reference) and 90%CIs were obtained from the model. The AMD and 90%CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90%CI for the ratios.||425.41|318.91|
72498037|NCT05032950|144526507|OTHER||Reference/Test Ratio|1430.02|||||TWO_SIDED|90.0|1204.54|1697.71|||Mixed Models Analysis|||Natural log-transformed AUCinf of midazolam was analyzed using mixed effect model with treatment, period and sequence as fixed effects and participant in sequence as random effect. Estimates of the adjusted mean differences (AMD) (Test-Reference) and 90%CIs were obtained from the model. The AMD and 90%CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90%CI for the ratios.||1697.71|1204.54|
72498038|NCT05032950|144526508|OTHER||Test/Reference Ratio|1451.78|||||TWO_SIDED|90.0|1224.42|1721.35|||Mixed Models Analysis|||Natural log-transformed AUClast of midazolam was analyzed using mixed effect model with treatment, period and sequence as fixed effects and participant in sequence as random effect. Estimates of the adjusted mean differences (AMD) (Test-Reference) and 90%CIs were obtained from the model. The AMD and 90%CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90%CI for the ratios.||1721.35|1224.42|
72498039|NCT05032950|144526513|OTHER||Test/Reference Ratio|387.2|||||TWO_SIDED|90.0|335.25|447.21|||Mixed Models Analysis|||Natural log-transformed Cmax of midazolam was analyzed using mixed effect model with treatment, period and sequence as fixed effects and participant in sequence as random effect. Estimates of the adjusted mean differences (AMD)(Test-Reference) and 90%CIs were obtained from the model. The AMD and 90%CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90%CI for the ratios.||447.21|335.25|
72561261|NCT01628549|144653080|SUPERIORITY||Difference vs placebo in success rate|13.2||||0.0159|TWO_SIDED|95.0|0.54|25.6|||Cochran-Mantel-Haenszel|||||25.60|0.54|0.0159
72561262|NCT01628549|144653080|SUPERIORITY||Difference vs placebo in success rate|4.1||||0.4834|TWO_SIDED|95.0|-7.44|15.87|||Cochran-Mantel-Haenszel|||||15.87|-7.44|0.4834
72561263|NCT01405469|144653088|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-7.44|STANDARD_DEVIATION|2.66|<|0.001||95.0|||||t-test, 2 sided|||this pilot study was created ro evaluate sample size for the following multicenter study, based on manometric outcomes. Mean values between baseline and follow-up were compared using Student ' s t -test for paired samples. P values less then 0.05, two-sided, were considered significant.R 2.13.1(R Development Core Team (2011). Subgroups (partial vs. complete myotomy) were compared using an analysis of variance test adjusted for initial values.||||<0.001
72561264|NCT00974350|144653129|SUPERIORITY||LS Mean Difference|-1.14|STANDARD_ERROR_OF_MEAN|0.353||0.0031|TWO_SIDED|95.0|-1.84|-0.44|||ANOVA|LS Mean difference from SABER-Placebo||Pain Intensity on Movement AUCs1-72 hours Including Pain Assessed Upon Taking Opioid Rescue - ITT||-0.44|-1.84|0.0031
72561265|NCT00974350|144653130|SUPERIORITY|||||||0.0909|||||||Cochran-Mantel-Haenszel|Stratified by pooled study sites||Proportion of Patients Not Taking Any Supplemental Opioid Analgesic Medication||||0.0909
72561266|NCT01344018|144653140|SUPERIORITY|"Time assessment biases were taken into account for the primary endpoint:~* Surgery alone arm: abdominal recurrence occurring prior to week 14 assessment was counted as occurring at week 14; progression occurring after the week 14 was counted as occurring at week 24.~* Preoperative RT arm: abdominal recurrence occurring was counted as occurring at week 14; and any abdominal recurrence occurring after and prior to or during the week 24 will be counted as occurring at week 24."|Hazard Ratio (HR)|1.01||||0.955|TWO_SIDED|95.0|0.71|1.44||A 5% significance level was considered as a threshold for statistical significance.|Regression, Cox|The time assessment biases correction described before was not applied to patients for whom death was the first event.|The arm having surgery alone was the reference arm.|Sample size was determined to provide 90% power for detecting a Hazard Ratio (HR)=0.52 (which corresponds to a 20% difference in ARFS rate at 5 years, from 50% in the surgery arm to 70% in the experimental arm) at a global 2-sided 5% significance level assuming ARFS followed an exponential distribution in both arms. This test required 102 events at the time of the statistical analysis.||1.44|0.71|0.955
72446825|NCT05119023|144410446|OTHER|||||||0.32||||||The threshold for statistical significance was p = 0.05|Pearson's correlation|||Examination of Attention and Characterization of learning: AGL Rule Based Learning||||0.32
72446826|NCT05119023|144410447|OTHER|Sample underpowered for regression so correlation examined||||||0.64||||||The threshold for statistical significance was p = 0.05|Pearson's correlation|||Examination of Working Memory and Characterization of learning: SRT Observational Learning Scores||||0.64
72446827|NCT05119023|144410447|OTHER|||||||0.01||||||The threshold for statistical significance was p = 0.05|Pearson's correlation|||Examination of Working Memory and Characterization of learning: AGL Observational Learning Scores||||0.01
72446828|NCT05119023|144410447|OTHER|||||||0.79|||||||Pearson's correlation|||Examination of Working Memory and Characterization of learning: AGL Rule-based Learning Scores||||0.79
72446829|NCT05119023|144410448|OTHER|Sample underpowered for regression so correlation examined||||||0.9||||||The threshold for statistical significance was p = 0.05|Pearson's correlation|||Examination of Executive Function and Characterization of learning: SRT Observational Learning Scores||||0.90
72446830|NCT05119023|144410448|OTHER|||||||0.09||||||The threshold for statistical significance was p = 0.05|Pearson's correlation|||Examination of Executive Function and Characterization of learning: AGL Observational Learning Scores||||0.09
72446831|NCT05119023|144410448|OTHER|||||||0.24|||||||Pearson's correlation|||Examination of Executive Function and Characterization of learning: AGL Rule-based Learning Scores||||0.24
72446832|NCT00875277|144410470|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
72446833|NCT00875277|144410470|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
72446834|NCT00875277|144410470|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
72446835|NCT00875277|144410470|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
72446836|NCT00875277|144410470|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
72446837|NCT00875277|144410470|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
72446838|NCT00875277|144410470|SUPERIORITY|||||||0.035|||||||t-test, 2 sided|||||||0.035
72446839|NCT00875277|144410470|SUPERIORITY|||||||0.082|||||||t-test, 2 sided|||||||0.082
72446840|NCT00875277|144410470|SUPERIORITY|||||||0.009|||||||t-test, 2 sided|||||||0.009
72446841|NCT00875277|144410470|SUPERIORITY|||||||0.012|||||||t-test, 2 sided|||||||0.012
72446842|NCT00875277|144410470|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
72446843|NCT00875277|144410470|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
72446844|NCT00875277|144410470|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
72446845|NCT00875277|144410470|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
72446846|NCT00875277|144410470|SUPERIORITY|||||||0.089|||||||t-test, 2 sided|||||||0.089
72446847|NCT04292223|144410500|OTHER|Comparison of the 16-week value with the baseline value|Mean Difference (Final Values)|14.0|STANDARD_ERROR_OF_MEAN|2.5|<|0.0001|TWO_SIDED|95.0|8.8|19.3|||Mixed Models Analysis|||||19.3|8.8|<0.0001
72446848|NCT05210608|144410560|SUPERIORITY||Mean Difference (Final Values)|1.36|STANDARD_ERROR_OF_MEAN|0.55||0.29|TWO_SIDED|95.0|-0.85|2.18||The threshold for statistical significance was p=0.05.|t-test, 2 sided|||We analyzed whether significant changes occurred between baseline and the post-treatment assessment.||2.18|-.85|.29
72446849|NCT05210608|144410560|SUPERIORITY||Mean Difference (Final Values)|1.92|STANDARD_ERROR_OF_MEAN|1.45||0.48|TWO_SIDED|95.0|-3.45|5.79||The threshold for statistical significance was p=0.05.|t-test, 2 sided|||We analyzed whether significant changes occurred between baseline and the 1 month follow up||5.79|-3.45|.48
72446850|NCT05210608|144410561|SUPERIORITY||Mean Difference (Final Values)|37.7|STANDARD_ERROR_OF_MEAN|14.8|=|0.015|TWO_SIDED|95.0|19.9|102.1||The threshold for statistical significance was p = 0.05.|t-test, 2 sided|||We analyzed whether there were significant differences in number of total cigarettes smoked per week from baseline to Post-treatment.||102.10|19.90|=0.015
72446851|NCT05210608|144410561|SUPERIORITY||Mean Difference (Final Values)|17.03|STANDARD_ERROR_OF_MEAN|24.69||0.08|TWO_SIDED|95.0|-14.57|142.57|||t-test, 2 sided|||We analyzed whether there were significant differences in number of total cigarettes smoked per week from baseline to 1 month follow-up.||142.57|-14.57|.08
72446852|NCT05210608|144410562|SUPERIORITY||Mean Difference (Final Values)|0.03|STANDARD_ERROR_OF_MEAN|3.64||0.9|TWO_SIDED|95.0|-9.86|8.86|||t-test, 2 sided|||We analyzed whether there were significant differences in carbon monoxide ppm from baseline to Post-treatment.||8.86|-9.86|.90
72446853|NCT05210608|144410562|SUPERIORITY||Mean Difference (Final Values)|-12.3|STANDARD_ERROR_OF_MEAN|11.29||0.32|TWO_SIDED|95.0|-49.42|22.42|||t-test, 2 sided|||We analyzed whether there were significant difference in carbon monoxide ppm from baseline to the 1 month follow-up.||22.42|-49.42|.32
72446854|NCT05210608|144410563|SUPERIORITY||Mean Difference (Final Values)|-2.72|STANDARD_ERROR_OF_MEAN|4.36||0.18|TWO_SIDED|95.0|-5.1|19.1|||t-test, 2 sided|||We analyzed whether there were significant differences in working memory scores from baseline to post-treatment.||19.10|-5.10|.18
72446855|NCT05210608|144410563|SUPERIORITY||Mean Difference (Final Values)|-12.64|STANDARD_ERROR_OF_MEAN|5.14||0.18|TWO_SIDED|95.0|-25.38|7.38|||t-test, 2 sided|||We analyzed whether there were significant differences in working memory scores from baseline to the 1 month follow up.||7.38|-25.38|.18
72446856|NCT05851573|144410564|OTHER||||||<|0.05|||||||t-test, 2 sided|df = 9||||||< .05
72446857|NCT05851573|144410565|OTHER||||||=|0.775|||||||t-test, 2 sided|df = 9||||||= .775
72561267|NCT01344018|144653145|SUPERIORITY|ARFI was described using cumulative incidence curves. ARFI was compared between the two treatment arms using a Fine and Gray model.|Hazard Ratio (HR)|1.09||||0.658|TWO_SIDED|95.0|0.74|1.6||A 5% significance level was considered as a threshold for statistical significance.|Fine and Gray model|||||1.60|0.74|0.658
72561268|NCT01344018|144653146|SUPERIORITY||Hazard Ratio (HR)|0.89||||0.595|TWO_SIDED|95.0|0.58|1.36||A 5% significance level was considered as a threshold for statistical significance.|Regression, Cox|||||1.36|0.58|0.595
72561269|NCT01344018|144653147|SUPERIORITY||Hazard Ratio (HR)|1.16||||0.615|TWO_SIDED|95.0|0.65|2.05|||Regression, Cox|||||2.05|0.65|0.615
72561270|NCT05070754|144653148|SUPERIORITY|||||||0.534|||||||Chi-squared|||Outcome measures 1-3 were all tested together. Null hypothesis was that there was no difference in the degree of lesion resolution between the two treatment methods.||||0.534
72561271|NCT05070754|144653149|SUPERIORITY|||||||0.534|||||||Chi-squared|||Outcome measures 1-3 were all tested together. Null hypothesis was that there was no difference in the degree of lesion resolution between the two treatment methods.||||0.534
72561272|NCT05070754|144653150|SUPERIORITY|||||||0.534|||||||Chi-squared|||Outcome measures 1-3 were all tested together. Null hypothesis was that there was no difference in the degree of lesion resolution between the two treatment methods.||||0.534
72561273|NCT05070754|144653151|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
72561274|NCT05070754|144653152|SUPERIORITY|||||||0.142|||||||Wilcoxon Signed Rank Test|||Null hypothesis: there was no difference in median pain levels between SOC and NTAP treated lesions.||||0.142
72446858|NCT05851573|144410566|OTHER||||||=|0.444|||||||t-test, 2 sided|df = 10||||||= .444
72446859|NCT05851573|144410567|OTHER|||||||0.959|||||||t-test, 2 sided|df = 9||||||.959
72446860|NCT05851573|144410568|OTHER|||||||0.068|||||||t-test, 2 sided|df = 9||||||.068
72446861|NCT05851573|144410569|OTHER||||||=|0.119|||||||t-test, 2 sided|df = 10||||||= .119
72446862|NCT05851573|144410570|OTHER||||||=|0.258|||||||t-test, 2 sided|df = 10||||||= .258
72446863|NCT05851573|144410571|OTHER||||||=|0.593|||||||t-test, 2 sided|df = 10||||||= .593
72446864|NCT04473222|144410589|SUPERIORITY||Odds Ratio, log|-0.15||||0.026|TWO_SIDED||||||t-test, 2 sided||The logit represents the difference in log odds per 1-week change in time for the intervention group relative to enhanced usual care.|||||.026
72446865|NCT04473222|144410590|SUPERIORITY||Odds Ratio, log|-0.2||||0.032|TWO_SIDED||||||t-test, 2 sided||The logit represents the difference in log odds per 1-week change in time for the intervention group relative to enhanced usual care.|||||0.032
72446866|NCT04473222|144410591|SUPERIORITY||Slope|-0.01|STANDARD_ERROR_OF_MEAN|0.009||0.01|TWO_SIDED||||||t-test, 2 sided||The estimate represents the differential change in slope per week for the intervention group relative to enhanced usual care.|||||.010
72446867|NCT04473222|144410592|SUPERIORITY||Slope|0.009|STANDARD_ERROR_OF_MEAN|0.009||0.161|TWO_SIDED||||||t-test, 2 sided||The estimate represents the differential change in slope per week for the intervention group relative to enhanced usual care.|||||0.161
72446868|NCT04473222|144410593|SUPERIORITY||Slope|-0.03|STANDARD_ERROR_OF_MEAN|0.01||0.006|TWO_SIDED||||||t-test, 2 sided||The estimate represents the differential change in slope per week for the intervention group relative to enhanced usual care.|||||0.006
72446869|NCT04473222|144410594|SUPERIORITY||Slope|0.07|STANDARD_ERROR_OF_MEAN|0.04||0.045|TWO_SIDED||||||t-test, 2 sided||The estimate represents the differential change in slope per week for the intervention group relative to enhanced usual care.|||||0.045
72561275|NCT04404907|144653175|OTHER|ANOVA||||||0.02|||||||ANOVA|||feel more attractive||||0.02
72561276|NCT04404907|144653175|OTHER|ANOVA||||||0.001|||||||ANOVA|||tanning helps relax||||0.001
72446870|NCT04473222|144410595|SUPERIORITY||Slope|-0.05|STANDARD_ERROR_OF_MEAN|0.11||0.685|TWO_SIDED||||||t-test, 2 sided||The estimate represents the differential change in slope per week for the intervention group relative to enhanced usual care.|||||0.685
72446871|NCT04473222|144410596|SUPERIORITY||Slope|0.42|STANDARD_ERROR_OF_MEAN|1.22||0.734|TWO_SIDED||||||t-test, 2 sided||The estimate represents the differential change in slope per week for the intervention group relative to enhanced usual care.|||||0.734
72446872|NCT04473222|144410597|SUPERIORITY||Slope|-0.2|STANDARD_ERROR_OF_MEAN|0.08||0.019|TWO_SIDED||||||t-test, 2 sided||The estimate represents the differential change in slope per week for the intervention group relative to enhanced usual care.|||||0.019
72446873|NCT04473222|144410598|SUPERIORITY||Slope|-0.04|STANDARD_ERROR_OF_MEAN|0.14||0.776|TWO_SIDED||||||t-test, 2 sided||The estimate represents the differential change in slope per week for the intervention group relative to enhanced usual care.|||||0.776
72446874|NCT04636528|144410639|EQUIVALENCE|A minimal detectable difference of 11.2 points was selected based on the psychometric properties of the scale. Considering a power of 80%, a 2-sided 0.05 significance level, and a 10% dropout rate, 82 patients would be necessary to detect an 11.2-point difference between the 2 groups.|Median Difference (Net)|-1.8||||0.75|TWO_SIDED|95.0|-13.5|9.8||The threshold for statistical significance was set at 0.05.|quantile mixed-effects model|a robust method on the medians||||9.8|-13.5|0.75
72446875|NCT04636528|144410639|EQUIVALENCE||Odds Ratio (OR)|0.84||||0.71|TWO_SIDED|95.0|0.32|2.16||The threshold for statistical significance was set at 0.05.|Regression, Logistic|||||2.16|0.32|0.71
72561277|NCT04404907|144653175|OTHER|||||||0.34|||||||ANOVA|||confident with a tan||||0.34
72561278|NCT04404907|144653175|OTHER|||||||0.0004|||||||ANOVA|||Social activity||||0.0004
72561279|NCT04404907|144653175|OTHER|||||||0.66|||||||ANOVA|||Important to protect skin from the sun||||0.66
72561280|NCT04404907|144653175|OTHER|||||||0.16|||||||ANOVA|||Concern about develop skin cancer||||0.16
72561281|NCT04404907|144653175|OTHER|||||||0.29|||||||ANOVA|||Chances of getting skin cancer are high||||0.29
72561282|NCT00283842|144653176|SUPERIORITY_OR_OTHER|||||||0.084|||||||Hochberg|||Statistical analysis provided for 50mg.||||0.084
72561283|NCT00283842|144653176|SUPERIORITY_OR_OTHER|||||||0.084|||||||Hochberg|||Statistical analysis provided for 100mg.||||0.084
72561284|NCT00283842|144653176|SUPERIORITY_OR_OTHER|||||||0.001|||||||Hochberg|||Statistical analysis provided for 200mg.||||0.001
72561285|NCT00283842|144653176|SUPERIORITY_OR_OTHER|||||||0.027|||||||Hochberg|||Statistical analysis provided for 400mg.||||0.027
72561286|NCT00283842|144653177|SUPERIORITY_OR_OTHER|||||||0.375|||||||Hochberg|||Statistical analysis provided for 50mg.||||0.375
72561287|NCT00283842|144653177|SUPERIORITY_OR_OTHER|||||||0.342|||||||Hochberg|||Statistical analysis provided for 100mg.||||0.342
72561288|NCT00283842|144653177|SUPERIORITY_OR_OTHER|||||||0.342|||||||Hochberg|||Statistical analysis provided for 200mg.||||0.342
72561289|NCT00283842|144653177|SUPERIORITY_OR_OTHER|||||||0.375|||||||Hochberg|||Statistical analysis provided for 400mg.||||0.375
72561290|NCT05068661|144653178|SUPERIORITY||Risk Ratio (RR)|0.75||||0.486|TWO_SIDED|95.0|0.4|1.39|||Chi-squared|||||1.39|0.40|0.486
72561291|NCT05068661|144653179|SUPERIORITY||Risk Ratio (RR)|0.85||||0.148|TWO_SIDED|95.0|0.69|1.06||This is adjusted P value for hypotension|Chi-squared|||||1.06|0.69|0.148
72561292|NCT05068661|144653180|SUPERIORITY||Risk Ratio (RR)|1.04|||>|0.999|TWO_SIDED|95.0|0.98|1.1||This is adjusted P value|Chi-squared|||||1.10|0.98|>0.999
72561293|NCT05068661|144653181|SUPERIORITY||Mean Ratio|1.9||||0.128|TWO_SIDED|95.0|1.14|3.18||Adjusted P value|Regression, Linear|||||3.18|1.14|0.128
72619371|NCT01657500|144769547|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|See above|||||<|0.05|TWO_SIDED||||||t-test, 2 sided|||Main outcome measure was endothelial cell loss at 6 months after EK. Sample size and statistical power calculations for testing equivalence of means within 10% range were performed at 80% power/0.025 level of significance. 20% variability was assumed. 6-month endothelial cell loss) should not differ significantly for surgeon-prepared versus eye bank-prepared tissue. Assuming pairs of corneas matched by pt. diagnosis and other characteristics, the required sample size was 34 donor pairs.||||< 0.05
72446876|NCT04636528|144410640|EQUIVALENCE||Median Difference (Net)|-0.6||||0.12|TWO_SIDED|95.0|-1.4|-0.2||The threshold for statistical significance was set at 0.05.|Quantile mixed-effects model|a robust method on the medians||||-0.2|-1.4|0.12
72446877|NCT04636528|144410641|EQUIVALENCE||Median Difference (Net)|-2.2||||0.89|TWO_SIDED|95.0|-34.6|30.2||The threshold for statistical significance was set at 0.05.|Quantile mixed-effects model|||||30.2|-34.6|0.89
72446878|NCT04636528|144410642|EQUIVALENCE||Median Difference (Net)|-0.3||||0.51|TWO_SIDED|95.0|-1.0|0.5|||Quantile mixed-effects model|a robust method on the medians||||0.5|-1.0|0.51
72446879|NCT04636528|144410643|EQUIVALENCE||Median Difference (Final Values)|2.0|||<|0.001|TWO_SIDED|||||The threshold for statistical significance was set at 0.05.|t-test, 2 sided|||||||<0.001
72561294|NCT05068661|144653182|SUPERIORITY||Mean Ratio|1.04|||>|0.999|TWO_SIDED|95.0|0.8|1.35||Adjusted P value|Regression, Linear|||||1.35|0.80|>0.999
72561295|NCT05068661|144653183|SUPERIORITY||Mean Ratio|0.97|||>|0.999|TWO_SIDED|95.0|0.93|1.3||Adjusted P value|Regression, Linear|||||1.30|0.93|>0.999
72446880|NCT04636528|144410644|EQUIVALENCE||Median Difference (Net)|-1.1|||<|0.001|TWO_SIDED|95.0|-1.5|0.6||The threshold for statistical significance was set at 0.05.|Quantile mixed-effects model|a robust method on the medians||||0.6|-1.5|<.001
72446881|NCT04636528|144410645|EQUIVALENCE||Median Difference (Net)|-0.9|||<|0.001|TWO_SIDED|95.0|-1.4|-0.5||The threshold for statistical significance was set at 0.05.|Quantile mixed-effects model|a robust method on the medians||||-0.5|-1.4|<.001
72446882|NCT04636528|144410646|EQUIVALENCE||Median Difference (Net)|-0.5||||0.27|TWO_SIDED|95.0|-1.3|0.4||The threshold for statistical significance was set at 0.05.|Quantile mixed-effects model|A robust method on the medians.||||0.4|-1.3|.27
72446883|NCT04636528|144410647|EQUIVALENCE||Difference in proportions|11.8||||0.14|TWO_SIDED||||||Chi-squared|||||||0.14
72446884|NCT04636528|144410648|EQUIVALENCE||Mean Difference (Final Values)|12.7|||<|0.001|TWO_SIDED|||||The threshold for statistical significance was set at 0.05.|Wilcoxon (Mann-Whitney)|||||||<0.001
72446885|NCT04636528|144410649|EQUIVALENCE||Mean Difference (Final Values)|67.7||||0.36|TWO_SIDED|||||The threshold for statistical significance was set at 0.05.|Wilcoxon (Mann-Whitney)|||||||0.36
72446886|NCT04636528|144410650|EQUIVALENCE||Mean Difference (Final Values)|1.62|||<|0.001|TWO_SIDED|||||The threshold for statistical significance was set at 0.05.|Wilcoxon (Mann-Whitney)|||||||<0.001
72446887|NCT01369355|144410666|SUPERIORITY_OR_OTHER_LEGACY|||||||0.04||||||A fixed sequence testing procedure was used to control alpha at 0.05 over the outcome measures.|Cochran-Mantel-Haenszel chi-square test|2-sided Cochran-Mantel-Haenszel chi-square test, stratified by clinical remission at Week 0, ustekinumab induction dose and the induction study.||||||0.040
72561296|NCT05068661|144653184|SUPERIORITY||Risk Ratio (RR)|0.81|||>|0.999|TWO_SIDED|95.0|0.52|1.25||Adjusted P value|Chi-squared|||||1.25|0.52|>0.999
72561297|NCT05068661|144653185|SUPERIORITY||Risk Ratio (RR)|0.85|||>|0.999|TWO_SIDED|95.0|0.58|1.24||Adjusted P value|Chi-squared|||||1.24|0.58|>0.999
72561298|NCT05068661|144653186|SUPERIORITY||Mean Ratio|1.03|||>|0.999|TWO_SIDED|95.0|0.86|1.22||Adjusted P value|Regression, Linear|||||1.22|0.86|>0.999
72561299|NCT01742208|144653303|SUPERIORITY||LS Mean Difference|-25.14||||0.007|TWO_SIDED|95.0|-42.78|-7.49||Threshold for significance at 0.05 level.|ANCOVA||Difference is sotagliflozin - placebo|Between-group comparison of the 2 Expansion Groups was based on an ANCOVA model with covariates of baseline mean total daily bolus insulin, treatment group, factor used to stratify the randomization (screening A1C \<= 8%, \> 8%), and random effect of participant\*treatment group.||-7.49|-42.78|0.007
72561300|NCT00715676|144653310|SUPERIORITY_OR_OTHER|||||||0.641||||||The Hochberg method was used to compare dose groups to placebo and control the Type 1 error rate.|ANOVA|||A sample size of 49 per treatment group was calculated to have at least 90% power to detect a 2% or greater increase over placebo assuming the following: (1) a standard deviation of the percent change of 2.75% (2) a dropout rate of 30%, and (3) one-sided 0.05 level of significance||||0.641
72561301|NCT00715676|144653310|SUPERIORITY_OR_OTHER|||||||0.243||95.0||||The Hochberg method was used to compare dose groups to placebo and control the Type 1 error rate.|ANOVA|||A sample size of 49 per treatment group was calculated to have at least 90% power to detect a 2% or greater increase over placebo assuming the following: (1) a standard deviation of the percent change of 2.75% (2) a dropout rate of 30%, and (3) one-sided 0.05 level of significance||||0.243
72446888|NCT01369355|144410666|SUPERIORITY_OR_OTHER_LEGACY|||||||0.005||||||A fixed sequence testing procedure was used to control alpha at 0.05 over the outcome measures.|Cochran-Mantel-Haenszel chi-square test|2-sided Cochran-Mantel-Haenszel chi-square test, stratified by clinical remission at Week 0, ustekinumab induction dose and the induction study.||||||0.005
72446889|NCT01369355|144410667|SUPERIORITY_OR_OTHER_LEGACY|||||||0.033||||||A fixed sequence testing procedure was used to control alpha at 0.05 over the outcome measures.|Cochran-Mantel-Haenszel chi-square test|2-sided Cochran-Mantel-Haenszel chi-square test, stratified by clinical remission at Week 0, ustekinumab induction dose and the induction study.||||||0.033
72561302|NCT00715676|144653311|SUPERIORITY_OR_OTHER|||||||0.778||95.0|||||ANOVA|||||||0.778
72446890|NCT01369355|144410667|SUPERIORITY_OR_OTHER_LEGACY|||||||0.018||||||A fixed sequence testing procedure was used to control alpha at 0.05 over the outcome measures.|Cochran-Mantel-Haenszel chi-square test|2-sided Cochran-Mantel-Haenszel chi-square test, stratified by clinical remission at Week 0, ustekinumab induction dose and the induction study.||||||0.018
72446891|NCT01369355|144410668|SUPERIORITY_OR_OTHER_LEGACY|||||||0.189||||||A fixed sequence testing procedure was used to control alpha at 0.05 over the outcome measures.|Cochran-Mantel-Haenszel chi-square test|2-sided Cochran-Mantel-Haenszel chi-square test, stratified by ustekinumab induction dose and the induction study.||||||0.189
72446892|NCT01369355|144410668|SUPERIORITY_OR_OTHER_LEGACY|||||||0.007||||||A fixed sequence testing procedure was used to control alpha at 0.05 over the outcome measures.|Cochran-Mantel-Haenszel chi-square test|2-sided Cochran-Mantel-Haenszel chi-square test, stratified by ustekinumab induction dose and the induction study.||||||0.007
72446893|NCT01369355|144410669|SUPERIORITY_OR_OTHER_LEGACY|||||||0.035||||||A fixed sequence testing procedure was used to control alpha at 0.05 over the outcome measures.|Cochran-Mantel-Haenszel chi-square test|2-sided Cochran-Mantel-Haenszel chi-square test, stratified by clinical remission at Week 0, ustekinumab induction dose and the induction study.||||||0.035
72446894|NCT01369355|144410669|SUPERIORITY_OR_OTHER_LEGACY|||||||0.004||||||A fixed sequence testing procedure was used to control alpha at 0.05 over the outcome measures.|Cochran-Mantel-Haenszel chi-square test|2-sided Cochran-Mantel-Haenszel chi-square test, stratified by clinical remission at Week 0, ustekinumab induction dose and the induction study.||||||0.004
72446895|NCT01369355|144410670|SUPERIORITY_OR_OTHER_LEGACY|||||||0.14||||||A fixed sequence testing procedure was used to control alpha at 0.05 over the outcome measures.|Cochran-Mantel-Haenszel chi-square test|2 sided Cochran-Mantel-Haenszel chi-square test, stratified by clinical remission status at Week 0 and ustekinumab induction dose.||||||0.140
72561303|NCT00715676|144653311|SUPERIORITY_OR_OTHER|||||||0.173||95.0|||||ANOVA|||||||0.173
72561304|NCT00715676|144653312|SUPERIORITY_OR_OTHER|||||||0.395||95.0|||||ANOVA|||||||0.395
72446896|NCT01369355|144410670|SUPERIORITY_OR_OTHER_LEGACY|||||||0.102||||||A fixed sequence testing procedure was used to control alpha at 0.05 over the outcome measures.|Cochran-Mantel-Haenszel chi-square test|2 sided Cochran-Mantel-Haenszel chi-square test, stratified by clinical remission status at Week 0 and ustekinumab induction dose.||||||0.102
72446897|NCT02359890|144410705|SUPERIORITY_OR_OTHER_LEGACY||Percentage of participants with events|2.6|||||TWO_SIDED|95.0|0.7|6.5|||||The 2-sided 95% confidence interval is derived using the exact Clopper-Pearson interval.|||6.5|0.7|
72446898|NCT02359890|144410707|SUPERIORITY_OR_OTHER_LEGACY||Percentage of patient with acute success|96.2|||||TWO_SIDED|95.0|92.0|98.6|||||The 2-sided 95% confidence interval is derived using the exact Clopper-Pearson interval|||98.6|92.0|
72446899|NCT02547233|144410736|SUPERIORITY||Ratio of clearance rates|30.55|||<|0.001|TWO_SIDED|95.0|4.28|218.0|||Mantel Haenszel||Mantel-Haenszel estimate (0.018% relative to vehicle), adjusted for pooled sites.|||218.0|4.28|<0.001
72446900|NCT02547233|144410737|SUPERIORITY||Ratio of clearance rates|12.26|||<|0.001|TWO_SIDED|95.0|4.73|31.78|||Mantel Haenszel||Mantel-Haenszel estimate (0.018% relative to vehicle), adjusted for pooled sites.|The p-values for secondary endpoints have been corrected by the Holm-Bonferroni method to account for multiplicity. The prespecified multiplicity adjustment by the Holm-Bonferroni method requires the ordering of the p-values for the secondary endpoints by size.||31.78|4.73|<0.001
72446901|NCT02547233|144410738|SUPERIORITY||Ratio of clearance rates|10.31|||<|0.001|TWO_SIDED|95.0|4.43|23.97|||Mantel Haenszel||Mantel-Haenszel estimate (0.018% relative to vehicle), adjusted for pooled sites.|The p-values for secondary endpoints have been corrected by the Holm-Bonferroni method to account for multiplicity. The prespecified multiplicity adjustment by the Holm-Bonferroni method requires the ordering of the p-values for the secondary endpoints by size.||23.97|4.43|<0.001
72446902|NCT02547233|144410739|SUPERIORITY||Week 8 AK count ratio|0.3|||<|0.001|TWO_SIDED|95.0|0.25|0.37||Negative binominal regression with treatment group and pooled site as factors and log baseline count as offset variable.|Mantel Haenszel||0.018% relative to vehicle.|The p-values for secondary endpoints have been corrected by the Holm-Bonferroni method to account for multiplicity. The prespecified multiplicity adjustment by the Holm-Bonferroni method requires the ordering of the p-values for the secondary endpoints by size.||0.37|0.25|<0.001
72446903|NCT03524612|144410795|OTHER||||||<|0.0001|||||||Clopper Pearson test|||||||<0.0001
72498040|NCT05032950|144526514|OTHER||Test/Reference Ratio|1645.15|||||TWO_SIDED|90.0|1385.75|1953.11|||Mixed Models Analysis|||Natural log-transformed AUCinf of midazolam was analyzed using mixed effect model with treatment, period and sequence as fixed effects and participant in sequence as random effect. Estimates of the adjusted mean differences (AMD)(Test-Reference) and 90%CIs were obtained from the model. The AMD and 90%CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90%CI for the ratios||1953.11|1385.75|
72561305|NCT00715676|144653312|SUPERIORITY_OR_OTHER|||||||0.523||95.0|||||ANOVA|||||||0.523
72561306|NCT00715676|144653313|SUPERIORITY_OR_OTHER|||||||0.928||95.0|||||ANOVA|||||||0.928
72561307|NCT00715676|144653313|SUPERIORITY_OR_OTHER|||||||0.124||95.0|||||ANOVA|||||||0.124
72561308|NCT00715676|144653314|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.173||||||90.0|0.164|0.181||||||||0.181|0.164|
72561309|NCT00715676|144653314|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.582||||||90.0|0.573|0.591||||||||0.591|0.573|
72561310|NCT01091363|144653317|SUPERIORITY||Odds Ratio (OR)|4.67|||<|0.01|TWO_SIDED|95.0|1.67|12.99|||Regression, Logistic|||||12.99|1.67|<0.01
72619372|NCT00449007|144769586|SUPERIORITY||Mean Difference (Final Values)|4.5||||1|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||"Difference between 6 months and baseline for Bupropion treated group.~Due to the low number of participants, the results are unreliable."||||1.0
72498041|NCT05032950|144526515|OTHER||Test/Reference Ratio|1677.25|||||TWO_SIDED|90.0|1414.59|1988.69|||Mixed Models Analysis|||Natural log-transformed AUClast of midazolam was analyzed using mixed effect model with treatment, period and sequence as fixed effects and participant in sequence as random effect. Estimates of the adjusted mean differences (AMD)(Test-Reference) and 90%CIs were obtained from the model. The AMD and 90%CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90%CI for the ratios.||1988.69|1414.59|
72498042|NCT02116621|144526547|SUPERIORITY||Adjusted difference in differences|-1.36|||||TWO_SIDED|95.0|-2.91|0.19|||||Adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control) from baseline to 26 weeks.|||0.19|-2.91|
72561311|NCT01091363|144653318|SUPERIORITY_OR_OTHER|Hayes' PROCESS computation tool for a serial multiple mediator model predicting a binary logistic outcome.|Mean Difference (Net)|1.92||||0.02|TWO_SIDED|95.0|0.34|6.32|||Mediation Analysis|||Mediation analyses were performed to examine the effect of the intervention on abstinence via the three theoretic variables (attitudes, perceived family norms, and self-efficacy), using the Hayes' PROCESS computation tool for a serial multiple mediator model with a binary outcome variable (quitting vs. smoking).||6.32|0.34|0.02
72561312|NCT00216060|144653320|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.08||||0.3|TWO_SIDED|95.0|0.51|8.4|||Regression, Cox|||||8.40|0.51|0.3
72561313|NCT00216060|144653321|SUPERIORITY_OR_OTHER|||||||0.12|TWO_SIDED||||||univariate analysis|||||||0.12
72561314|NCT00216060|144653323|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Kruskal-Wallis|||||||<0.001
72561315|NCT00216060|144653325|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Kruskal-Wallis|||||||<0.001
72561316|NCT00216060|144653326|SUPERIORITY_OR_OTHER|||||||0.01|TWO_SIDED||||||Kruskal-Wallis|||||||0.010
72561317|NCT00216060|144653327|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Kruskal-Wallis|||||||<0.001
72561318|NCT00360490|144653335|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||The null hypothesis: the absolute change from Baseline MBL to End of Study MBL is equal in the LNG IUS group and the MPA group.||||<0.001
72561319|NCT00360490|144653336|SUPERIORITY_OR_OTHER||Risk Difference (RD)|62.59|||<|0.001||95.0|50.56|74.61|||Chi-squared|||The null hypothesis: the proportion of subjects with successful treatment is equal in the LNG IUS group and the MPA group.||74.61|50.56|<0.001
72561320|NCT00360490|144653337|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-49.2|||<|0.001||95.0|-70.2|-28.3|||t-test, 2 sided|||The null hypothesis: the percent change from Baseline MBL to End of Study MBL is equal in the LNG IUS group and the MPA group.||-28.3|-70.2|<0.001
72561321|NCT00360490|144653338|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||The null hypothesis: the absolute change from Baseline MBL to Mid-study MBL is equal in the LNG IUS group and the MPA group.||||<0.001
72561322|NCT00360490|144653339|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-50.6|||<|0.001||95.0|-63.8|-37.4|||t-test, 2 sided|||The null hypothesis: the percent change from Baseline MBL to Mid-study MBL is equal in the LNG IUS group and the MPA group.||-37.4|-63.8|<0.001
72561323|NCT00360490|144653349|SUPERIORITY_OR_OTHER||Risk Difference (RD)|26.06||||||95.0|14.75|37.36||||||A two-sided 95% confidence interval for the improvement rate will be provided for cycle 6||37.36|14.75|
72561324|NCT03538262|144653350|OTHER|||||||0.006|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 12||||0.006
72561325|NCT03538262|144653350|OTHER|Statistical analysis for BL to Month 24|||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
72390311|NCT00042289|144288451|SUPERIORITY||Geometric mean ratio|0.82||||0.0325|TWO_SIDED|90.0|0.71|0.96||3rd Trimester vs. Postpartum \[Note: Comparison of 2nd Trimester vs. Postpartum was not done due to low sample size.\]|Wilcoxon signed-rank test|||||0.96|0.71|0.0325
72390312|NCT00042289|144288451|SUPERIORITY||Geometric mean ratio|0.65|||<|0.05|TWO_SIDED|90.0|0.54|0.77||3rd Trimester vs. Postpartum \[Note: Comparison of 2nd Trimester vs. Postpartum was not done due to low sample size.\]|Wilcoxon signed-rank test|||||0.77|0.54|<0.05
72390313|NCT00042289|144288451|SUPERIORITY||||||<|0.05||||||2nd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||||<0.05
72390314|NCT00042289|144288451|SUPERIORITY||||||<|0.05||||||3rd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||||<0.05
72390315|NCT00042289|144288451|SUPERIORITY||||||>|0.05||||||2nd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||||>0.05
72390316|NCT00042289|144288451|SUPERIORITY||||||>|0.05||||||3rd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||||>0.05
72390317|NCT00042289|144288451|SUPERIORITY||||||<|0.05||||||2nd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||||<0.05
72390318|NCT00042289|144288451|SUPERIORITY||||||<|0.05||||||3rd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||||<0.05
72390319|NCT00042289|144288452|SUPERIORITY||Geometric mean ratio|0.88|||<|0.05|TWO_SIDED|90.0|0.73|1.06||3rd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||1.06|0.73|<0.05
72390320|NCT00042289|144288452|SUPERIORITY||Geometric mean ratio|0.7|||<|0.05|TWO_SIDED|90.0|0.55|0.9||2nd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||0.90|0.55|<0.05
72561326|NCT03538262|144653351|OTHER|||||||0.011|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 12||||0.011
72561327|NCT03538262|144653351|OTHER||||||<|0.001|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 24||||<0.001
72561328|NCT03538262|144653352|OTHER|||||||0.007|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 3||||0.007
72561329|NCT03538262|144653352|OTHER||||||<|0.001|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 6||||<0.001
72561330|NCT03538262|144653352|OTHER|||||||0.004|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 9||||0.004
72561331|NCT03538262|144653352|OTHER||||||<|0.001|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 12||||<0.001
72561332|NCT03538262|144653352|OTHER||||||<|0.001|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 15||||<0.001
72561333|NCT03538262|144653352|OTHER||||||<|0.001|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 18||||<0.001
72561334|NCT03538262|144653352|OTHER||||||<|0.001|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 21||||<0.001
72561335|NCT03538262|144653352|OTHER||||||<|0.001|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 24||||<0.001
72561336|NCT03538262|144653353|OTHER|||||||0.996|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 6||||0.996
72561337|NCT03538262|144653353|OTHER|||||||0.054|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 12||||0.054
72561338|NCT03538262|144653353|OTHER|||||||0.025|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 18||||0.025
72498043|NCT02116621|144526548|SUPERIORITY|||||||0.21|||||||Mixed Models Analysis||||Longitudinal analysis adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control). Baseline to 13 weeks: -0.79 (-2.37 to 0.80); baseline to 26 weeks: -1.36 (-2.91 to 0.19); baseline to 52 weeks: 0.16 (-1.47 to 1.79)|||0.21
72561339|NCT03538262|144653353|OTHER|||||||0.006|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 24||||0.006
72561340|NCT03538262|144653354|OTHER|||||||0.145|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 12||||0.145
72561341|NCT03538262|144653354|OTHER|||||||0.029|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 24||||0.029
72619373|NCT00066170|144769619|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Dunnett's|||||||<0.001
72498044|NCT02116621|144526549|SUPERIORITY|||||||0.06|||||||Mixed Models Analysis||||Longitudinal analysis adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control). Baseline to 13 weeks: 0.31 (-1.18 to 1.81); baseline to 26 weeks: -1.41 (-2.87 to 0.06); baseline to 52 weeks: -1.24 (-2.77 to 0.30)|||0.06
72498045|NCT02116621|144526550|SUPERIORITY|||||||0.35|||||||Mixed Models Analysis||||Longitudinal analysis adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control). Baseline to 13 weeks:-0.66 (-2.55 to 1.24); baseline to 26 weeks: 0.93 (-0.92 to 2.79); baseline to 52 weeks: 0.76 (-1.19 to 2.70)|||0.35
72498046|NCT02116621|144526551|SUPERIORITY|||||||0.86|||||||Mixed Models Analysis||||Longitudinal analysis adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control). Baseline to 13 weeks: 0.30 (-1.01 to 1.61); baseline to 26 weeks: -0.17 (-1.45 to 1.12); baseline to 52 weeks: -0.26 (-1.61 to 1.09)|||0.86
72498047|NCT02116621|144526552|SUPERIORITY|||||||0.7|||||||Mixed Models Analysis||||Longitudinal analysis adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control). Baseline to 13 weeks: 1.05 (-2.54 to 4.64); baseline to 26 weeks: 1.90 (-1.66 to 5.47); baseline to 52 weeks: 0.08 (-3.61 to 3.77).|||0.70
72498048|NCT02116621|144526553|SUPERIORITY|||||||0.2|||||||Mixed Models Analysis||||Longitudinal analysis adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control). Baseline to 13 weeks: 4.24 (-2.73 to 11.20); baseline to 26 weeks: 4.64 (-2.25 to 11.54); baseline to 52 weeks: -1.91 (-9.07 to 5.26).|||0.20
72390321|NCT00042289|144288452|SUPERIORITY||Geometric mean ratio|0.84|||<|0.05|TWO_SIDED|90.0|0.57|1.23||3rd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||1.23|0.57|<0.05
72390322|NCT00042289|144288456|SUPERIORITY||Geometric mean of ratio|1.24||||0.114|TWO_SIDED|90.0|0.97|1.59||Before ENG initiation vs. after ENG initiation|Wilcoxon signed rank test|||The statistical analysis is for LPV PK.||1.59|0.97|0.114
72390323|NCT00042289|144288457|SUPERIORITY||Geometric mean of ratio|1.1||||0.367|TWO_SIDED|90.0|0.84|1.44||Before ENG initiation vs. after ENG initiation|Wilcoxon signed rank test|||The statistical test is for ATV PK.||1.44|0.84|0.367
72561342|NCT03538262|144653355|OTHER||||||<|0.001|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 12||||<.001
72561343|NCT03538262|144653355|OTHER||||||<|0.001|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 24||||<0.001
72561344|NCT03538262|144653356|OTHER|||||||0.382|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 12||||0.382
72561345|NCT03538262|144653356|OTHER||||||<|0.001|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 24||||<0.001
72561346|NCT03538262|144653357|OTHER|||||||0.688|||||||Mixed Models Analysis|||Secondary analysis for BL to Month 12||||0.688
72390324|NCT00042289|144288457|SUPERIORITY||Geometric mean of ratio|1.02||||0.561|TWO_SIDED|90.0|0.92|1.13|||Wilcoxon signed rank test|Before ENG initiation vs. after ENG initiation||The statistical test is for EFV PK.||1.13|0.92|0.561
72390325|NCT01687998|144288482|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.006||||0.9054|TWO_SIDED|95.0|0.911|1.111|||Regression, Cox|||Primary Endpoint: Time to First Occurrence of the Composite Primary Endpoint of Cardiovascular (CV) Death, Myocardial Infarction (MI), Stroke, Coronary Revascularization, or Hospitalization for Unstable Angina (UA)||1.111|0.911|0.9054
72390326|NCT01687998|144288483|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-37.11|||<|0.0001|TWO_SIDED|95.0|-38.15|-36.08|||ANOVA|||LDL-C||-36.08|-38.15|<0.0001
72390327|NCT01687998|144288483|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|131.55|||<|0.0001|TWO_SIDED|95.0|130.01|133.09|||ANOVA|||HDL-C||133.09|130.01|<0.0001
72561347|NCT03538262|144653357|OTHER|||||||0.293|||||||Mixed Models Analysis|||Secondary analysis for BL to Month 24||||0.293
72561348|NCT03538262|144653358|OTHER|||||||0.446|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 12||||0.446
72561349|NCT03538262|144653358|OTHER|||||||0.565|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 24||||0.565
72561350|NCT03538262|144653359|OTHER|||||||0.006|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 12||||0.006
72561351|NCT03538262|144653359|OTHER|||||||0.937|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 24||||0.937
72561352|NCT03538262|144653360|OTHER|||||||0.041|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 3||||0.041
72390328|NCT01687998|144288484|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.991||||0.8463|TWO_SIDED|95.0|0.901|1.089|||Regression, Cox|||Time to First Occurrence of the Composite Endpoint of All-Cause Mortality, MI, Stroke, Coronary Revascularization, or Hospitalization for UA||1.089|0.901|0.8463
72390329|NCT01687998|144288485|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.001||||0.9874|TWO_SIDED|95.0|0.901|1.112|||Regression, Cox|||Time to First Occurrence of the Composite Endpoint of CV Death, MI, or Coronary Revascularization||1.112|0.901|0.9874
72390330|NCT01687998|144288486|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.003||||0.9574|TWO_SIDED|95.0|0.893|1.127|||Regression, Cox|||Time to First Occurrence of the Composite Endpoint of CV Death, MI, Stroke, or Hospitalization for UA||1.127|0.893|0.9574
72561353|NCT03538262|144653360|OTHER||||||<|0.001|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 6||||<0.001
72619374|NCT00066170|144769619|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Dunnett's|||||||<0.001
72619375|NCT00098293|144769620|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was to be concluded if the lower bound of the 1-sided 97.5% CI was greater than (\>) -10%.|Difference in Percentage|-3.0|||||ONE_SIDED|97.5|-9.5|||||||Less than 400 copies/mL: Treatment difference in percentages stratified by randomization strata (screening viral load and geographic region) was presented along with the lower bound of the 1-sided 97.5% confidence interval (CI) based on the normal approximation to the binomial distribution. Positive value would favor maraviroc. Step down procedure used to control for multiple comparisons.|||-9.5|
72498049|NCT02116621|144526554|SUPERIORITY|||||||0.66|||||||Mixed Models Analysis||||Longitudinal analysis adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control). Baseline to 13 weeks: 1.76 (-2.37 to 5.89); baseline to 26 weeks: 2.55 (-1.50 to 6.60); baseline to 52 weeks: 1.53 (-2.70 to 5.77).|||0.66
72498050|NCT02116621|144526555|SUPERIORITY|||||||0.44|||||||Mixed Models Analysis||||Longitudinal analysis adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control). Baseline to 13 weeks: 7.77 (-2.87 to 18.42); baseline to 26 weeks: 7.29 (-3.16 to 17.75); baseline to 52 weeks: 4.13 (-6.81 to 15.07).|||0.44
72498051|NCT02116621|144526556|SUPERIORITY|||||||0.58|||||||Mixed Models Analysis||||Longitudinal analysis adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control). Baseline to 13 weeks: 2.15 (-2.84 to 7.13); baseline to 26 weeks: 3.31 (-1.57 to 8.19); baseline to 52 weeks: 1.00 (-4.11 to 6.11).|||0.58
72498052|NCT02116621|144526557|SUPERIORITY|||||||0.73|||||||Mixed Models Analysis||||Longitudinal analysis adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control). Baseline to 13 weeks: 1.81 (-4.41 to 8.02); baseline to 26 weeks: -1.57 (-7.68 to 4.54); baseline to 52 weeks: 1.11 (-5.27 to 7.48).|||0.73
72498053|NCT02116621|144526558|SUPERIORITY||Adjusted difference in differences|-1.41|||||TWO_SIDED|95.0|-2.87|0.06|||||Adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control) from baseline to 26 weeks.|||0.06|-2.87|
72498054|NCT02116621|144526559|SUPERIORITY||Adjusted difference in differences|0.93|||||TWO_SIDED|95.0|-0.92|2.79|||||||Adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control) from baseline to 26 weeks.|2.79|-0.92|
72390331|NCT01687998|144288487|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.965||||0.5917|TWO_SIDED|95.0|0.846|1.1|||Regression, Cox|||Time to First Occurrence of Triple Composite Endpoint of CV Death, MI, or Stroke||1.100|0.846|0.5917
72390332|NCT00745823|144288488|NON_INFERIORITY_OR_EQUIVALENCE|The 800 mg q.d. dosage was considered non-inferior to 400 mg b.i.d. if the lower bound of the 2-sided exact 95% CI for difference in response rate remained above -10%.|Mean Difference (Final Values)|-5.7||||0.044|TWO_SIDED|95.0|-10.7|-0.83|||Miettinen and Nurminen|||||-0.83|-10.7|0.044
72390333|NCT00745823|144288489|NON_INFERIORITY_OR_EQUIVALENCE|The 800 mg q.d. dosage was considered non-inferior to 400 mg b.i.d. if the lower bound of the 2-sided exact 95% CI for difference in response rate remained above -10%.|Mean Difference (Final Values)|-5.1||||0.011|TWO_SIDED|95.0|-9.29|-1.06|||Miettinen and Nurminen|||||-1.06|-9.29|0.011
72390334|NCT00745823|144288490|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|||||TWO_SIDED|95.0|-5.0|4.6|||Miettinen and Nurminen|||||4.6|-5.0|
72390335|NCT00745823|144288491|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3|||||TWO_SIDED|95.0|-1.3|2.0||||||||2.0|-1.3|
72390336|NCT00745823|144288492|SUPERIORITY_OR_OTHER||Mean Difference (Net)|13.56|||||TWO_SIDED|95.0|-7.29|34.4|||t-test, 2 sided|||||34.40|-7.29|
72390337|NCT02955602|144288500|OTHER||||||=|0.2242|||||||ANCOVA|||The analyses will assess the change from baseline in each treatment group and will assess the hypothesis that there are no differences in the percent change in ALP serum level between seladelpar 2 mg and 5 mg treatment groups after 8 weeks of treatment.||||= 0.2242
72390338|NCT02955602|144288500|OTHER||||||=|0.0021|||||||ANCOVA|||The analyses will assess the change from baseline in each treatment group and will assess the hypothesis that there are no differences in the percent change in ALP serum level between seladelpar 2 mg and 10 mg treatment groups after 8 weeks of treatment||||= 0.0021
72390339|NCT02955602|144288500|OTHER||||||=|0.0024|||||||ANCOVA|||The analyses will assess the change from baseline in each treatment group and will assess the hypothesis that there are no differences in the percent change in ALP serum level between seladelpar 5 mg and 10 mg treatment groups after 8 weeks of treatment||||= 0.0024
72390340|NCT03156543|144288519|SUPERIORITY|||||||0.004|||||||Fisher Exact|||Analysis was based on the participants who were positive for C. acnes.||||0.004
72390341|NCT01509950|144288521|SUPERIORITY|||||||0.6|||||||t-test, 2 sided|||||||0.60
72390342|NCT04115839|144288553|SUPERIORITY||Difference in response rates|26.9||||0.022|TWO_SIDED|95.0|4.3|49.6||The stratification factors (Geographic Region, Concurrent Use of conventional synthetic (cs) DMARD(s) and/or Apremilast at Randomization, Prior Use of biologic (bio)DMARD(s)) and treatment groups were included in the imputation model as covariates.|Multiple imputation method|||||49.6|4.3|0.022
72390343|NCT04115839|144288553|SUPERIORITY||Difference in response rates|2.2||||0.89|TWO_SIDED|95.0|-20.5|25.0||The stratification factors (Geographic Region, Concurrent Use of csDMARD(s) and/or Apremilast at Randomization, Prior Use of bioDMARD(s)) and treatment groups were included in the imputation model as covariates.|Multiple imputation method|||||25.0|-20.5|0.89
72390344|NCT04115839|144288556|SUPERIORITY||Difference in response rates|-5.9||||0.39|TWO_SIDED|95.0|-21.6|9.9||P-value was calculated from the logistic regression with treatment groups and stratification factors (geographic Region, concurrent Use of csDMARD(s) and/or Apremilast at Randomization, prior use of bioDMARD(s)) in the model.|Regression, Logistic||95% confidence interval (CI) for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||9.9|-21.6|0.39
72390345|NCT04115839|144288556|SUPERIORITY||Difference in response rates|-2.6||||0.65|TWO_SIDED|95.0|-19.7|14.5||P-value was calculated from the logistic regression with treatment groups and stratification factors (geographic Region, concurrent Use of csDMARD(s) and/or Apremilast at Randomization, prior use of bioDMARD(s)) in the model.|Regression, Logistic||95% confidence interval (CI) for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||14.5|-19.7|0.65
72390346|NCT04115839|144288556|SUPERIORITY||Difference in response rates|0.9||||0.86|TWO_SIDED|-19.4|-19.4|21.3||P-value was calculated from the logistic regression with treatment groups and stratification factors (geographic Region, concurrent Use of csDMARD(s) and/or Apremilast at Randomization, prior use of bioDMARD(s)) in the model.|Regression, Logistic||95% confidence interval (CI) for difference in response rates were based on normal approximation method with a continuity correction.|Week 8||21.3|-19.4|0.86
72390347|NCT04115839|144288556|SUPERIORITY||Difference in response rates|-2.9||||0.7|TWO_SIDED|95.0|-22.0|16.1||P-value was calculated from the logistic regression with treatment groups and stratification factors (geographic Region, concurrent Use of csDMARD(s) and/or Apremilast at Randomization, prior use of bioDMARD(s)) in the model.|Regression, Logistic||95% confidence interval (CI) for difference in response rates were based on normal approximation method with a continuity correction.|Week 8||16.1|-22.0|0.70
72446904|NCT05457647|144410820|OTHER|The accuracy and precision of the theranostic imaging biomarkers, including both the riboflavin score and theranostic score, to predict CXL treatment outcome were determined by calculating the proportion of correctly classified eyes and the positive predictive value respectively.|Proportion|91.0|||||TWO_SIDED|95.0|||||||The study set a minimum threshold of 85 for the the combined use of the theranostic imaging biomarkers' accuracy and precision in predicting the propensity of CXL to halt disease progression at 1 year in the study population.|Accuracy and precision of the combined use of theranostic imaging biomarkers generated by the UV-A device to predict the propensity of CXL in flattening the Kmax value at 12-months.||||
72446905|NCT05457647|144410821|OTHER|Paired Wilcoxon signed-rank test was used to compare the distributions preoperatively and 12-months postoperatively.|||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||Assessment of change of Kmax value at 12-months follow-up visit.||||<0.05
72446906|NCT05457647|144410822|OTHER|Paired Wilcoxon signed-rank test was used to compare the distributions preoperatively and 12-months postoperatively.|||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||Assessment of change of ECD value at 12-months follow-up visit.||||<0.05
72446907|NCT05457647|144410823|OTHER|Paired Wilcoxon signed-rank test was used to compare the distributions preoperatively and 12-months postoperatively.|||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||Assessment of change of MSER value at 12-months follow-up visit.||||<0.05
72446908|NCT05457647|144410824|OTHER|Paired Wilcoxon signed-rank test was used to compare the distributions preoperatively and 12-months postoperatively.|||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||Assessment of change of CDVA value at 12-months follow-up visit.||||<0.05
72446909|NCT05457647|144410825|OTHER|Paired Wilcoxon signed-rank test was used to compare the distributions preoperatively and 12-months postoperatively.|||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||Assessment of change of UDVA value at 12-months follow-up visit.||||<0.05
72498055|NCT02116621|144526560|SUPERIORITY||Adjusted difference in differences|-0.17|||||TWO_SIDED|95.0|-1.45|1.12|||||||Adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control) from baseline to 26 weeks.|1.12|-1.45|
72446910|NCT05457647|144410826|OTHER|Paired Wilcoxon signed-rank test was used to compare the distributions preoperatively and 12-months postoperatively.|||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||Assessment of change of CCT value at 12-months follow-up visit.||||<0.05
72446911|NCT05457647|144410827|OTHER|Paired Wilcoxon signed-rank test was used to compare the distributions preoperatively and 12-months postoperatively. Bonferroni correction was applied to analysis of exploratory outcome measures of stratification groups.|||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
72446912|NCT03976362|144410843|SUPERIORITY||Hazard Ratio (HR)|0.77||||0.004|TWO_SIDED|95.0|0.63|0.93||One-sided p-value based on log-rank test stratified by Eastern Cooperative Cancer Group (ECOG) at pre-randomization visit, response at randomization and baseline PD-L1 status.|Log Rank||Based on Cox regression model with Efron's method of tie handling and with treatment as a covariate stratified by ECOG at pre-randomization visit, response at randomization and baseline PD-L1 status.|||0.93|0.63|0.0040
72446913|NCT03976362|144410844|SUPERIORITY||Hazard Ratio (HR)|1.01||||0.5481|TWO_SIDED|95.0|0.83|1.24||One-sided p-value based on log-rank test stratified by ECOG at pre-randomization visit, response at randomization and baseline PD-L1 status.|Log Rank||Based on Cox regression model with Efron's method of tie handling and with treatment as a covariate stratified by ECOG at pre-randomization visit, response at randomization and baseline PD-L1 status.|||1.24|0.83|0.5481
72446914|NCT03976362|144410847|OTHER||Difference in LS Means|0.37||||0.8238|TWO_SIDED|95.0|-2.91|3.66||Based on cLDA model with the PRO scores as the response variable with covariates for treatment by time interaction, stratification factors, response at randomization, and baseline PD-L1 expression as covariates.|t-test, 2 sided||Based on cLDA model with the PRO scores as the response variable with covariates for treatment by time interaction, stratification factors, response at randomization, and baseline PD-L1 expression as covariates.|||3.66|-2.91|0.8238
72446915|NCT03976362|144410848|OTHER||Hazard Ratio (HR)|0.87||||0.3083|TWO_SIDED|95.0|0.66|1.14||Two-sided p-value based on log-rank test stratified by ECOG at pre-randomization Visit, response at randomization, and baseline PD-L1 expression.|Log Rank||Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG at pre-randomization Visit, response at randomization, and baseline PD-L1 expression.|||1.14|0.66|0.3083
72446916|NCT03976362|144410849|OTHER||Difference in Least Square Means|1.68||||0.4686|TWO_SIDED|95.0|-2.87|6.23||Based on cLDA model with the PRO scores as the response variable with covariates for treatment by time interaction, stratification factors, response at randomization, and baseline PD-L1 expression as covariates.|t-test, 2 sided||Based on cLDA model with the PRO scores as the response variable with covariates for treatment by time interaction, stratification factors, response at randomization, and baseline PD-L1 expression as covariates.|||6.23|-2.87|0.4686
72446917|NCT03976362|144410850|OTHER||Hazard Ratio (HR)|1.01||||0.9174|TWO_SIDED|95.0|0.76|1.35||Two-sided p-value based on log-rank test stratified by ECOG at pre-randomization visit, response at randomization, and baseline PD-L1 expression.|Log Rank||Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG at pre-randomization visit, response at randomization, and baseline PD-L1 expression.|||1.35|0.76|0.9174
72446918|NCT03976362|144410851|OTHER||Difference in Least Square Means|3.83||||0.0245|TWO_SIDED|95.0|0.5|7.16||Based on cLDA model with the PRO scores as the response variable with covariates for treatment by time interaction, stratification factors, response at randomization, and baseline PD-L1 expression as covariates.|t-test, 2 sided||Based on cLDA model with the PRO scores as the response variable with covariates for treatment by time interaction, stratification factors, response at randomization, and baseline PD-L1 expression as covariates.|||7.16|0.50|0.0245
72446919|NCT03976362|144410852|OTHER||Hazard Ratio (HR)|1.24||||0.2133|TWO_SIDED|95.0|0.88|1.75||Two-sided p-value based on log-rank test stratified by ECOG at pre-randomization visit, response at randomization, and baseline PD-L1 expression.|Log Rank||Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG at pre-randomization visit, response at randomization, and baseline PD-L1 expression.|||1.75|0.88|0.2133
72498056|NCT02116621|144526561|SUPERIORITY||Adjusted difference in differences|1.9|||||TWO_SIDED|95.0|-1.66|5.47|||||||Adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control) from baseline to 26 weeks.|5.47|-1.66|
72561354|NCT03538262|144653360|OTHER||||||<|0.001|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 9||||<0.001
72446920|NCT03976362|144410853|OTHER||Hazard Ratio (HR)|0.18||||0.9381|TWO_SIDED|95.0|-4.27|4.62||Based on cLDA model with the PRO scores as the response variable with covariates for treatment by time interaction, stratification factors, response at randomization, and baseline PD-L1 expression as covariates.|t-test, 2 sided||Based on cLDA model with the PRO scores as the response variable with covariates for treatment by time interaction, stratification factors, response at randomization, and baseline PD-L1 expression as covariates.|||4.62|-4.27|0.9381
72446921|NCT03976362|144410854|OTHER||Hazard Ratio (HR)|0.97||||0.8464|TWO_SIDED|95.0|0.72|1.31||Two-sided p-value based on log-rank test stratified by ECOG at pre-randomization visit, response at randomization, and baseline PD-L1 expression.|Log Rank||Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG at pre-randomization visit, response at randomization, and baseline PD-L1 expression.|||1.31|0.72|0.8464
72446922|NCT03976362|144410855|OTHER||Difference in Least Square Means|-2.81||||0.087|TWO_SIDED|95.0|-6.02|0.41||Based on cLDA model with the PRO scores as the response variable with covariates for treatment by time interaction, stratification factors, response at randomization, and baseline PD-L1 expression as covariates.|t-test, 2 sided||Based on cLDA model with the PRO scores as the response variable with covariates for treatment by time interaction, stratification factors, response at randomization, and baseline PD-L1 expression as covariates.|||0.41|-6.02|0.0870
72446923|NCT03976362|144410856|OTHER||Hazard Ratio (HR)|1.6||||0.002|TWO_SIDED|95.0|1.18|2.16||Two-sided p-value based on log-rank test stratified by ECOG at pre-randomization visit, response at randomization, and baseline PD-L1 expression.|Log Rank||Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG at pre-randomization visit, response at randomization, and baseline PD-L1 expression.|||2.16|1.18|0.0020
72446924|NCT05486078|144410915|OTHER|Repeated measures ANOVA||||||0.001|||||||ANOVA|||Hip abduction strength was analyzed using repeated measures ANOVA. The assumption of sphericity was tested and Bonferroni correction was applied for pairwise comparisons. A p-value \< 0.001 was considered statistically significant.||||0.001
72498057|NCT02116621|144526562|SUPERIORITY||Adjusted difference in differences|4.64|||||TWO_SIDED|95.0|-2.25|11.54|||||||Adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control) from baseline to 26 weeks.|11.54|-2.25|
72498058|NCT02116621|144526563|SUPERIORITY||Adjusted difference in differences|2.55|||||TWO_SIDED|95.0|-1.5|6.6|||||||Adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control) from baseline to 26 weeks.|6.60|-1.50|
72498059|NCT02116621|144526564|SUPERIORITY||Adjusted difference in differences|7.29|||||TWO_SIDED|95.0|-3.16|17.75|||||||Adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control) from baseline to 26 weeks.|17.75|-3.16|
72561355|NCT03538262|144653360|OTHER||||||<|0.001|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 12||||<0.001
72561356|NCT03538262|144653360|OTHER||||||<|0.001|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 15||||<0.001
72446925|NCT05486078|144410916|OTHER|McNemar Exact Test|||||<|0.0001||||||P-value derived from McNemar exact test comparing binary outcome (improved vs. unchanged). Statistical significance threshold set at p \< 0.05.|McNemar|McNemar Exact Test||MRI improvement was assessed using paired evaluation of inflammatory signs (edema) at baseline and Week 24. McNemar exact test was used for within-subject categorical comparison.||||< 0.0001
72498060|NCT02116621|144526565|SUPERIORITY||Adjusted difference in differences|3.31|||||TWO_SIDED|95.0|-1.57|8.19|||||||Adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control) from baseline to 26 weeks.|8.19|-1.57|
72498061|NCT02116621|144526566|SUPERIORITY||Adjusted difference in differences|-1.57|||||TWO_SIDED|95.0|-7.68|4.54|||||||Adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control) from baseline to 26 weeks.|4.54|-7.68|
72498062|NCT02116621|144526567|SUPERIORITY||Mean Difference (Final Values)|11.9||||0.01|TWO_SIDED|95.0|2.59|21.24|||Regression, Linear|||||21.24|2.59|0.01
72446926|NCT05486078|144410917|OTHER|Friedman Test Within-group||||||0.992|||||||Friedman Test Within-group|||Analgesic use (units/week) was analyzed over time using the Friedman test for repeated measures. No significant variation across follow-up visits was found.||||0.992
72446927|NCT05590403|144410919|NON_INFERIORITY|Non-inferiority is demonstrated if the anti-RSV-A GMT ratio (OA-RSV Group over Adults-HA-RSV Group) is less than (\<) 1.5 at 1 month post RSVPreF3 OA vaccine administration.|GMT Ratio|0.95|||||TWO_SIDED|95.0|0.83|1.09|||||The comparison is done using the group ratio of adjusted GMT (OA-RSV/Adults-HA-RSV) (ANCOVA model applied to the log10- transformed titers). The ANCOVA model included the group as fixed effects and the pre-dose log-10 titer as covariate|To demonstrate the non-inferiority of the RSVPreF3 OA vaccine when administered to healthy adults aged 50-59 years of age compared with older adults aged 60 years of age or above.||1.09|0.83|
72498063|NCT02116621|144526568|SUPERIORITY||Adjusted difference in differences|-0.79|||||TWO_SIDED|95.0|-2.37|0.8|||||Adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control) from baseline to 13 weeks.|||0.80|-2.37|
72498064|NCT02116621|144526569|SUPERIORITY||Adjusted difference in differences|0.31|||||TWO_SIDED|95.0|-1.18|1.81|||||Adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control) from baseline to 13 weeks.|||1.81|-1.18|
72498065|NCT02116621|144526570|SUPERIORITY||Adjusted difference in differences|0.3|||||TWO_SIDED|95.0|-1.01|1.61|||||Adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control) from baseline to 13 weeks.|||1.61|-1.01|
72561357|NCT03538262|144653360|OTHER||||||<|0.001|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 18||||<0.001
72561358|NCT03538262|144653360|OTHER||||||<|0.001|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 21||||<0.001
72561359|NCT03538262|144653360|OTHER||||||<|0.001|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 24||||<0.001
72561360|NCT03538262|144653361|OTHER|||||||0.595|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 6||||0.595
72561361|NCT03538262|144653361|OTHER|||||||0.44|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 12||||0.440
72561362|NCT03538262|144653361|OTHER|||||||0.909|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 18||||0.909
72561363|NCT03538262|144653361|OTHER|||||||0.068|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 24||||0.068
72561364|NCT03538262|144653362|OTHER|||||||0.074|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 3||||0.074
72390348|NCT04115839|144288556|SUPERIORITY||Difference in response rates|12.4||||0.15|TWO_SIDED|95.0|-7.5|32.3||P-value was calculated from the logistic regression with treatment groups and stratification factors (geographic Region, concurrent Use of csDMARD(s) and/or Apremilast at Randomization, prior use of bioDMARD(s)) in the model.|Regression, Logistic||95% confidence interval (CI) for difference in response rates were based on normal approximation method with a continuity correction.|Week 12||32.3|-7.5|0.15
72446928|NCT05590403|144410920|NON_INFERIORITY|The non-inferiority is demonstrated if the UL of the 2-sided 95% CI on the group difference (OA-RSV Group minus Adults-HA-RSV Group) in terms of SRR is \<10%, at 1 month post RSVPreF3 OA vaccine administration.|Difference in percentage|-2.65|||||TWO_SIDED|95.0|-8.54|3.28|||||The comparison is done using the difference of SRR (OA-RSV -Adults-HA-RSV)|To demonstrate the non-inferiority of the RSVPreF3 OA vaccine when administered to healthy adults aged 50-59 years of age compared with older adults aged 60 years of age or above.||3.28|-8.54|
72446929|NCT05590403|144410921|NON_INFERIORITY|Non-inferiority is demonstrated if the anti-RSV-B GMT ratio (OA-RSV Group over Adults-HA-RSV Group) is \<1.5 at 1 month post RSVPreF3 OA vaccine administration.|GMT Ratio|0.89|||||TWO_SIDED|95.0|0.79|1.02|||||The comparison is done using the group ratio of adjusted GMT (OA-RSV/Adults-HA-RSV) (ANCOVA model applied to the log10- transformed titers). The ANCOVA model included the group as fixed effects and the pre-dose log-10 titer as covariate|To demonstrate the non-inferiority of the RSVPreF3 OA vaccine when administered to healthy adults aged 50-59 years of age compared with older adults aged 60 years of age or above.||1.02|0.79|
72446930|NCT05590403|144410922|NON_INFERIORITY|The non-inferiority is demonstrated if the UL of the 2-sided 95% CI on the group difference (OA-RSV Group minus Adults-HA-RSV Group) in terms of SRR is \<10%, at 1 month post RSVPreF3 OA vaccine administration.|Difference in percentage|-3.95|||||TWO_SIDED|95.0|-10.39|2.53|||||The comparison is done using the difference of SRR (OA-RSV -Adults-HA-RSV)|To demonstrate the non-inferiority of the RSVPreF3 OA vaccine when administered to healthy adults aged 50-59 years of age compared with older adults aged 60 years of age or above.||2.53|-10.39|
72446931|NCT05590403|144410923|NON_INFERIORITY|Non-inferiority is demonstrated if the anti-RSV-A GMT ratio (OA-RSV Group over Adults-AIR-RSV Group) is \<1.5 at 1 month post RSVPreF3 OA vaccine administration.|GMT Ratio|0.84|||||TWO_SIDED|95.0|0.73|0.96|||||The comparison is done using the group ratio of adjusted GMT (OA-RSV/Adults-AIR-RSV) (ANCOVA model applied to the log10- transformed titers). The ANCOVA model included the group as fixed effects and the pre-dose log-10 titer as covariate|To demonstrate the non-inferiority of the RSVPreF3 OA vaccine when administered to adults at increased risk of RSV-LRTD aged 50-59 years of age compared with older adults aged 60 years of age or above.||0.96|0.73|
72446932|NCT05590403|144410924|NON_INFERIORITY|The non-inferiority is demonstrated if the UL of the 2-sided 95% CI on the group difference (OA-RSV Group over Adults-AIR-RSV Group) in terms of SRR is \<10%, at 1 month post RSVPreF3 OA vaccine administration.|Difference in percentage|-6.67|||||TWO_SIDED|95.0|-12.26|-1.12|||||The comparison is done using the difference of SRR (OA-RSV -Adults-AIR-RSV)|To demonstrate the non-inferiority of the RSVPreF3 OA vaccine when administered to adults at increased risk of RSV-LRTD aged 50-59 years of age compared with older adults aged 60 years of age or above.||-1.12|-12.26|
72446933|NCT05590403|144410925|NON_INFERIORITY|Non-inferiority is demonstrated if the anti-RSV-B GMT ratio (OA-RSV Group over Adults-AIR-RSV Group) is \<1.5 at 1 month post RSVPreF3 OA vaccine administration.|GMT Ratio|0.8|||||TWO_SIDED|95.0|0.71|0.91|||||The comparison is done using the group ratio of adjusted GMT (OA-RSV/Adults-AIR-RSV) (ANCOVA model applied to the log10- transformed titers). The ANCOVA model included the group as fixed effects and the pre-dose log-10 titer as covariate|To demonstrate the non-inferiority of the RSVPreF3 OA vaccine when administered to adults at increased risk of RSV-LRTD aged 50-59 years of age compared with older adults aged 60 years of age or above.||0.91|0.71|
72446934|NCT05590403|144410926|NON_INFERIORITY|The non-inferiority is demonstrated if the UL of the 2-sided 95% CI on the group difference (OA-RSV Group over Adults-AIR-RSV Group) in terms of SRR is \<10%, at 1 month post RSVPreF3 OA vaccine administration.|Difference in percentage|-7.31|||||TWO_SIDED|95.0|-13.52|-1.09|||||The comparison is done using the difference of SRR (OA-RSV -Adults-AIR-RSV)|To demonstrate the non-inferiority of the RSVPreF3 OA vaccine when administered to adults at increased risk of RSV-LRTD aged 50-59 years of age compared with older adults aged 60 years of age or above.||-1.09|-13.52|
72561365|NCT03538262|144653362|OTHER||||||<|0.001|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 6||||<0.001
72390349|NCT04115839|144288556|SUPERIORITY||Difference in response rates|8.8||||0.3|TWO_SIDED|95.0|-10.1|27.7||P-value was calculated from the logistic regression with treatment groups and stratification factors (geographic Region, concurrent Use of csDMARD(s) and/or Apremilast at Randomization, prior use of bioDMARD(s)) in the model.|Regression, Logistic||95% confidence interval (CI) for difference in response rates were based on normal approximation method with a continuity correction.|Week 12||27.7|-10.1|0.30
72390350|NCT04115839|144288556|SUPERIORITY||Difference in response rates|22.3||||0.035|TWO_SIDED|95.0|-0.7|45.2||P-value was calculated from the logistic regression with treatment groups and stratification factors (geographic Region, concurrent Use of csDMARD(s) and/or Apremilast at Randomization, prior use of bioDMARD(s)) in the model.|Regression, Logistic||95% confidence interval (CI) for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||45.2|-0.7|0.035
72390351|NCT04115839|144288556|SUPERIORITY||Difference in response rates|12.1||||0.22|TWO_SIDED|95.0|-9.3|33.5||P-value was calculated from the logistic regression with treatment groups and stratification factors (geographic Region, concurrent Use of csDMARD(s) and/or Apremilast at Randomization, prior use of bioDMARD(s)) in the model.|Regression, Logistic||95% confidence interval (CI) for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||33.5|-9.3|0.22
72390352|NCT04115839|144288558|SUPERIORITY||Difference in response rates|0.0|||||TWO_SIDED|95.0|-2.8|2.8|||||95% CI for response rate and difference in response rates were based on normal approximation method with a continuity correction.|Week 4||2.8|-2.8|
72390353|NCT04115839|144288558|SUPERIORITY||Difference in response rates|0.0|||||TWO_SIDED|95.0|-2.9|2.9|||||95% CI for response rate and difference in response rates were based on normal approximation method with a continuity correction.|Week 4||2.9|-2.9|
72390354|NCT04115839|144288558|SUPERIORITY||Difference in response rates|3.1|||||TWO_SIDED|95.0|-5.9|12.2|||||95% CI for response rate and difference in response rates were based on normal approximation method with a continuity correction.|Week 8||12.2|-5.9|
72619376|NCT00098293|144769620|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was to be concluded if the lower bound of the 1-sided 97.5% CI was \> -10%.|Difference in Percentage|-4.2|||||ONE_SIDED|97.5|-10.9|||||||Less than 50 copies/mL: Treatment difference in percentages stratified by randomization strata (screening viral load and geographic region) was presented along with the lower bound of the 1-sided 97.5% CI based on the normal approximation to the binomial distribution. Positive value would favor maraviroc. Step down procedure used to control for multiple comparisons.|||-10.9|
72390355|NCT04115839|144288558|SUPERIORITY||Difference in response rates|0.0|||||TWO_SIDED|95.0|-2.9|2.9|||||95% CI for response rate and difference in response rates were based on normal approximation method with a continuity correction.|Week 8||2.9|-2.9|
72446935|NCT03701399|144410958|SUPERIORITY||Least squares mean difference|-0.06|STANDARD_ERROR_OF_MEAN|0.2||0.7581|TWO_SIDED|95.0|-0.47|0.34|||Mixed Models Analysis||Model based summary statistics were from a mixed model with repeated measures, including fixed effects for treatment, randomization stratum (SCA genotype group), visit, treatment-by-visit interaction, and country, baseline score as a covariate|All SCA participants||0.34|-0.47|0.7581
72390356|NCT04115839|144288558|SUPERIORITY||Difference in response rates|3.0|||||TWO_SIDED|95.0|-5.8|11.9|||||95% CI for response rate and difference in response rates were based on normal approximation method with a continuity correction.|Week 12||11.9|-5.8|
72390357|NCT04115839|144288558|SUPERIORITY||Difference in response rates|5.9|||||TWO_SIDED|95.0|-5.0|16.7|||||95% CI for response rate and difference in response rates were based on normal approximation method with a continuity correction.|Week 12||16.7|-5.0|
72390358|NCT04115839|144288558|SUPERIORITY||Difference in response rates|0.1|||||TWO_SIDED|95.0|-11.4|11.6|||||95% CI for response rate and difference in response rates were based on normal approximation method with a continuity correction.|Week 16||11.6|-11.4|
72390359|NCT04115839|144288558|SUPERIORITY||Difference in response rates|3.0|||||TWO_SIDED|95.0|-10.0|16.1|||||95% CI for response rate and difference in response rates were based on normal approximation method with a continuity correction.|Week 16||16.1|-10.0|
72390360|NCT04115839|144288566|SUPERIORITY||LS Mean Treatment Difference|0.0|STANDARD_ERROR_OF_MEAN|0.4||0.24|TWO_SIDED|95.0|-1.0|0.0||P-value was provided from mixed-effects model for repeated measures (MMRM) having treatment, visit (categorical), treatment by visit, stratification factors, baseline value as fixed effects, participants being the random effect.|MMRM|||Week 4||0|-1|0.24
72390361|NCT04115839|144288566|SUPERIORITY||LS Mean Treatment Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.4||0.22|TWO_SIDED|95.0|-1.0|0.0||P-value was provided from MMRM having treatment, visit (categorical), treatment by visit, stratification factors, baseline value as fixed effects, participants being the random effect.|MMRM|||Week 4||0|-1|0.22
72390362|NCT04115839|144288566|SUPERIORITY||LS Mean Treatment Difference|0.0|STANDARD_ERROR_OF_MEAN|0.5||0.43|TWO_SIDED|95.0|-1.0|1.0||P-value was provided from MMRM having treatment, visit (categorical), treatment by visit, stratification factors, baseline value as fixed effects, participants being the random effect.|MMRM|||Week 8||1|-1|0.43
72390363|NCT04115839|144288566|SUPERIORITY||LS Mean Treatment Difference|0.0|STANDARD_ERROR_OF_MEAN|0.5||0.7|TWO_SIDED|95.0|-1.0|1.0||P-value was provided from MMRM having treatment, visit (categorical), treatment by visit, stratification factors, baseline value as fixed effects, participants being the random effect.|MMRM|||Week 8||1|-1|0.70
72390364|NCT04115839|144288566|SUPERIORITY||LS Mean Treatment Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.5||0.1|TWO_SIDED|95.0|-2.0|0.0||P-value was provided from MMRM having treatment, visit (categorical), treatment by visit, stratification factors, baseline value as fixed effects, participants being the random effect.|MMRM|||Week 12||0|-2|0.10
72390365|NCT04115839|144288566|SUPERIORITY||LS Mean Treatment Difference|0.0|STANDARD_ERROR_OF_MEAN|0.5||0.9|TWO_SIDED|95.0|-1.0|1.0||P-value was provided from MMRM having treatment, visit (categorical), treatment by visit, stratification factors, baseline value as fixed effects, participants being the random effect.|MMRM|||Week 12||1|-1|0.90
72390366|NCT04115839|144288566|SUPERIORITY||LS Mean Treatment Difference|0.0|STANDARD_ERROR_OF_MEAN|0.5||0.88|TWO_SIDED|95.0|-1.0|1.0||P-value was provided from MMRM having treatment, visit (categorical), treatment by visit, stratification factors, baseline value as fixed effects, participants being the random effect.|MMRM|||Week 16||1|-1|0.88
72390367|NCT04115839|144288566|SUPERIORITY||LS Mean Treatment Difference|0.0|STANDARD_ERROR_OF_MEAN|0.5||0.89|TWO_SIDED|95.0|-1.0|1.0||P-value was provided from MMRM having treatment, visit (categorical), treatment by visit, stratification factors, baseline value as fixed effects, participants being the random effect.|MMRM|||Week 16||1|-1|0.89
72390368|NCT04115839|144288570|SUPERIORITY||Difference in response rates|0.3|||||TWO_SIDED|95.0|-15.9|16.5|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||16.5|-15.9|
72390369|NCT04115839|144288570|SUPERIORITY||Difference in response rates|12.6|||||TWO_SIDED|95.0|-7.1|32.3|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||32.3|-7.1|
72390370|NCT04115839|144288570|SUPERIORITY||Difference in response rates|26.6|||||TWO_SIDED|95.0|3.0|50.2|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||50.2|3.0|
72390371|NCT04115839|144288570|SUPERIORITY||Difference in response rates|18.2|||||TWO_SIDED|95.0|-4.1|40.4|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||40.4|-4.1|
72390372|NCT04115839|144288572|SUPERIORITY||Difference in response rates|2.9|||||TWO_SIDED|95.0|-5.6|11.5|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||11.5|-5.6|
72390373|NCT04115839|144288572|SUPERIORITY||Difference in response rates|0.0|||||TWO_SIDED|95.0|-2.9|2.9|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||2.9|-2.9|
72390374|NCT04115839|144288572|SUPERIORITY||Difference in response rates|12.9|||||TWO_SIDED|95.0|-2.0|27.8|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||27.8|-2.0|
72390375|NCT04115839|144288572|SUPERIORITY||Difference in response rates|9.1|||||TWO_SIDED|95.0|-3.7|21.9|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||21.9|-3.7|
72446936|NCT03701399|144410958|SUPERIORITY||Least square mean difference|-0.56|STANDARD_ERROR_OF_MEAN|0.28||0.045|TWO_SIDED|95.0|-1.11|-0.01|||Mixed Models Analysis||Model based summary statistics were from a mixed model with repeated measures, including fixed effects for treatment, randomization stratum (SCA genotype group), visit, treatment-by-visit interaction, and country.|SCA3 genotype participants||-0.01|-1.11|0.0450
72446937|NCT02132936|144411001|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.55|||<|0.001|TWO_SIDED|95.0|1.46|4.46|||Mantel Haenszel|||"Mantel-Haenszel odds of treatment success in LEO 90100 group relative to calcipotriol BDP gel group, adjusted for pooled centre and baseline PGA.~Multiple imputation was used to handle missing PGA values."||4.46|1.46|<0.001
72446938|NCT02132936|144411002|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.18|||=|0.001|TWO_SIDED|95.0|1.37|3.47|||Mantel Haenszel|||"Mantel-Haenszel odds of having PASI 75 in LEO 90100 group relative to calcipotriol BDP gel group, adjusted for pooled centre and baseline PGA.~Multiple imputation was used to handle missing data."||3.47|1.37|=0.001
72446939|NCT02132936|144411003|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Log Rank|||||||<0.001
72446940|NCT02132936|144411004|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||ANCOVA|||Mean change in itch adjusted for pooled centre, baseline PGA and baseline itch. Multiple imputation used for missing data.||||<0.001
72446941|NCT02132936|144411005|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.33|TWO_SIDED||||||ANCOVA|||Mean change in itch adjusted for pooled centre, baseline PGA and baseline itch. Multiple imputation used for missing data.||||=0.33
72498066|NCT02116621|144526571|SUPERIORITY||Adjusted difference in differences|-0.66|||||TWO_SIDED|95.0|-2.55|1.24|||||Adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control) from baseline to 13 weeks.|||1.24|-2.55|
72498067|NCT02116621|144526572|SUPERIORITY||Adjusted difference in differences|1.05|||||TWO_SIDED|95.0|-2.54|4.64|||||Adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control) from baseline to 13 weeks.|||4.64|-2.54|
72498068|NCT02116621|144526573|SUPERIORITY||Adjusted difference in differences|4.24|||||TWO_SIDED|95.0|-2.73|11.2|||||Adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control) from baseline to 13 weeks.|||11.20|-2.73|
72446942|NCT02561585|144411006|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.97|TWO_SIDED|95.0|-12.05|11.65||t-test in a baseline adjusted linear model|t-test, 2 sided|t-test, 2 sided on a 5% level||||11.65|-12.05|0.97
72446943|NCT03134196|144411020|SUPERIORITY||Hazard Ratio (HR)|0.78|STANDARD_DEVIATION|0.11|||TWO_SIDED|95.0|0.5|1.06||||||||1.06|0.5|
72446944|NCT03134196|144411021|SUPERIORITY||Hazard Ratio (HR)|0.74|STANDARD_DEVIATION|0.04|||TWO_SIDED|95.0|0.56|0.99||||||||0.99|0.56|
72446945|NCT00753545|144411034|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.35|||<|1e-05|TWO_SIDED|95.0|0.25|0.49|||Regression, Cox|The model includes factors for treatment, ethnic descent, platinum sensitivity and response to final platinum therapy.||HR \< 1 favours olaparib||0.49|0.25|<0.00001
72446946|NCT00753545|144411035|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.73||||0.02|TWO_SIDED|95.0|0.55|0.95|||Regression, Cox|The model includes factors for treatment, ethnic descent, platinum sensitivity and response to final platinum therapy.||HR \< 1 favours olaparib||0.95|0.55|0.02
72446947|NCT00753545|144411039|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS means|-27.1||||0.03185|TWO_SIDED|95.0|-51.9|-2.4|||ANCOVA|The model includes factors for treatment, ethnic descent, platinum sensitivity and response to final platinum therapy.||LS mean \< 0 favours olaparib||-2.4|-51.9|0.03185
72498069|NCT02116621|144526574|SUPERIORITY||Adjusted difference in differences|1.76|||||TWO_SIDED|95.0|-2.37|5.89|||||Adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control) from baseline to 13 weeks.|||5.89|-2.37|
72561366|NCT03538262|144653362|OTHER||||||<|0.001|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 9||||<0.001
72446948|NCT00753545|144411043|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.35|||<|1e-05|TWO_SIDED|95.0|0.25|0.47|||Regression, Cox|The model includes factors for treatment, ethnic descent, platinum sensitivity and response to final platinum therapy.||HR \< 1 favours olaparib||0.47|0.25|<0.00001
72446949|NCT00753545|144411047|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.23||||0.22|TWO_SIDED|95.0|0.88|1.71|||Regression, Cox|The model includes factors for treatment, ethnic descent, platinum sensitivity and response to final platinum therapy.||HR \< 1 favours olaparib||1.71|0.88|0.22
72446950|NCT00753545|144411048|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.08||||0.67|TWO_SIDED|95.0|0.75|1.56|||Regression, Cox|The model includes factors for treatment, ethnic descent, platinum sensitivity and response to final platinum therapy.||HR \< 1 favours olaparib||1.56|0.75|0.67
72446951|NCT00753545|144411049|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.16||||0.38|TWO_SIDED|95.0|0.83|1.64|||Regression, Cox|The model includes factors for treatment, ethnic descent, platinum sensitivity and response to final platinum therapy.||HR \< 1 favours olaparib||1.64|0.83|0.38
72446952|NCT03839940|144411131|SUPERIORITY||||||<|0.9999|||||||Fisher Exact|||||||< 0.9999
72446953|NCT03839940|144411132|SUPERIORITY|||||||0.3346|||||||Wilcoxon (Mann-Whitney)|||||||0.3346
72446954|NCT03839940|144411148|SUPERIORITY||||||<|0.70361|||||||Fisher Exact|||Female Population.||||< 0.70361
72498070|NCT02116621|144526575|SUPERIORITY||Adjusted difference in differences|7.77|||||TWO_SIDED|95.0|-2.87|18.42|||||Adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control) from baseline to 13 weeks.|||18.42|-2.87|
72561367|NCT03538262|144653362|OTHER||||||<|0.001|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 12||||<0.001
72561368|NCT03538262|144653362|OTHER||||||<|0.001|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 15||||<0.001
72561369|NCT03538262|144653362|OTHER||||||<|0.001|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 18||||<0.001
72561370|NCT03538262|144653362|OTHER||||||<|0.001|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 21||||<0.001
72446955|NCT03839940|144411148|SUPERIORITY||||||<|0.4667|||||||Fisher Exact|||Male population.||||<0.4667
72446956|NCT03839940|144411149|SUPERIORITY||||||<|1|||||||Fisher Exact|||Black or African American population||||<1.0
72446957|NCT03839940|144411149|SUPERIORITY||||||<|1|||||||Fisher Exact|||White population||||<1.0
72446958|NCT03839940|144411150|SUPERIORITY||||||<|1|||||||Fisher Exact|||Not Hispanic or Latino population.||||<1.0
72446959|NCT03839940|144411151|SUPERIORITY||||||<|0.1701|||||||Wilcoxon (Mann-Whitney)|||Female population.||||<0.1701
72446960|NCT03839940|144411151|SUPERIORITY||||||<|0.4811|||||||Wilcoxon (Mann-Whitney)|||Male population.||||<0.4811
72446961|NCT03839940|144411152|SUPERIORITY||||||<|1|||||||Wilcoxon (Mann-Whitney)|||Black or African American Population||||<1.0
72446962|NCT03839940|144411152|SUPERIORITY||||||<|0.5029|||||||Wilcoxon (Mann-Whitney)|||White Population||||<0.5029
72446963|NCT03839940|144411153|SUPERIORITY||||||<|0.295|||||||Wilcoxon (Mann-Whitney)|||Not Hispanic or Latino Population||||<0.2950
72446964|NCT04295798|144411198|EQUIVALENCE|Model effects included stimulation condition (i.e., gel-tDCS, sponge-tDCS, gel-sham and sponge-sham), time (pre-, post-stimulation), and their interaction. Previous studies showed age, sex, and BMI were associated with one or more metrics of standing or walking and were therefore included as covariates. Tukey's post-hoc testing was used to compare factor means of significant models.||||||0.02|||||||ANOVA|||We hypothesized a significant effect of intervention type on absolute change in dual task cost to gait speed from baseline to immediately post intervention.||||0.02
72446965|NCT04295798|144411199|EQUIVALENCE|Model effects included stimulation condition (i.e., gel-tDCS, sponge-tDCS, gel-sham and sponge-sham), time (pre-, post-stimulation), and their interaction. Previous studies showed age, sex, and BMI were associated with one or more metrics of standing or walking and were therefore included as covariates. Tukey's post-hoc testing was used to compare factor means of significant models.||||||0.02|||||||ANOVA|||We hypothesized a significant effect of intervention type on absolute change in dual task cost to standing postural sway speed from baseline to immediately post intervention.||||0.02
72446966|NCT04295798|144411200|EQUIVALENCE|Model effects included stimulation condition (i.e., gel-tDCS, sponge-tDCS, gel-sham and sponge-sham), time (pre-, post-stimulation), and their interaction. Previous studies showed age, sex, and BMI were associated with one or more metrics of standing or walking and were therefore included as covariates. Tukey's post-hoc testing was used to compare factor means of significant models.||||||0.04|||||||ANOVA|||We hypothesized a significant effect of intervention type on absolute change in dual task cost to stride time variability from baseline to immediately post intervention.||||0.04
72446967|NCT04295798|144411201|EQUIVALENCE|Model effects included stimulation condition (i.e., gel-tDCS, sponge-tDCS, gel-sham and sponge-sham), time (pre-, post-stimulation), and their interaction. Previous studies showed age, sex, and BMI were associated with one or more metrics of standing or walking and were therefore included as covariates. Tukey's post-hoc testing was used to compare factor means of significant models.||||||0.56|||||||ANOVA|||We hypothesized no significant effect of intervention type on absolute change in single task gait speed from baseline to immediately post intervention.||||0.56
72446968|NCT04295798|144411202|EQUIVALENCE|Model effects included stimulation condition (i.e., gel-tDCS, sponge-tDCS, gel-sham and sponge-sham), time (pre-, post-stimulation), and their interaction. Previous studies showed age, sex, and BMI were associated with one or more metrics of standing or walking and were therefore included as covariates. Tukey's post-hoc testing was used to compare factor means of significant models.||||||0.07|||||||ANOVA|||We hypothesized a significant effect of intervention type on absolute change in dual task gait speed from baseline to immediately post intervention.||||0.07
72446969|NCT04295798|144411203|EQUIVALENCE|Model effects included stimulation condition (i.e., gel-tDCS, sponge-tDCS, gel-sham and sponge-sham), time (pre-, post-stimulation), and their interaction. Previous studies showed age, sex, and BMI were associated with one or more metrics of standing or walking and were therefore included as covariates. Tukey's post-hoc testing was used to compare factor means of significant models.||||||0.74|||||||ANOVA|||We hypothesized no significant effect of intervention type on absolute change in single task stride time variability from baseline to immediately post intervention.||||0.74
72446970|NCT04295798|144411204|EQUIVALENCE|Model effects included stimulation condition (i.e., gel-tDCS, sponge-tDCS, gel-sham and sponge-sham), time (pre-, post-stimulation), and their interaction. Previous studies showed age, sex, and BMI were associated with one or more metrics of standing or walking and were therefore included as covariates. Tukey's post-hoc testing was used to compare factor means of significant models.||||||0.33|||||||ANOVA|||We hypothesized a significant effect of intervention type on absolute change in dual task stride time variability from baseline to immediately post intervention.||||0.33
72498071|NCT02116621|144526576|SUPERIORITY||Adjusted difference in differences|2.15|||||TWO_SIDED|95.0|-2.84|7.13|||||Adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control) from baseline to 13 weeks.|||7.13|-2.84|
72446971|NCT04295798|144411205|EQUIVALENCE|Model effects included stimulation condition (i.e., gel-tDCS, sponge-tDCS, gel-sham and sponge-sham), time (pre-, post-stimulation), and their interaction. Previous studies showed age, sex, and BMI were associated with one or more metrics of standing or walking and were therefore included as covariates. Tukey's post-hoc testing was used to compare factor means of significant models.||||||0.16|||||||ANOVA|||We hypothesized a significant effect of intervention type on absolute change in dual task cost to standing postural sway area from baseline to immediately post intervention.||||0.16
72446972|NCT04295798|144411206|EQUIVALENCE|Model effects included stimulation condition (i.e., gel-tDCS, sponge-tDCS, gel-sham and sponge-sham), time (pre-, post-stimulation), and their interaction. Previous studies showed age, sex, and BMI were associated with one or more metrics of standing or walking and were therefore included as covariates. Tukey's post-hoc testing was used to compare factor means of significant models.||||||0.52|||||||ANOVA|||We hypothesized no significant effect of intervention type on absolute change in single task postural sway speed from baseline to immediately post intervention.||||0.52
72498072|NCT02116621|144526577|SUPERIORITY||Adjusted difference in differences|1.81|||||TWO_SIDED|95.0|-4.41|8.02|||||Adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control) from baseline to 13 weeks.|||8.02|-4.41|
72498073|NCT02116621|144526578|SUPERIORITY||Adjusted difference in differences|0.16|||||TWO_SIDED|95.0|-1.47|1.79|||||Adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control) from baseline to 52 weeks.|||1.79|-1.47|
72561371|NCT03538262|144653362|OTHER||||||<|0.001|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 24||||<0.001
72446973|NCT04295798|144411207|EQUIVALENCE|Model effects included stimulation condition (i.e., gel-tDCS, sponge-tDCS, gel-sham and sponge-sham), time (pre-, post-stimulation), and their interaction. Previous studies showed age, sex, and BMI were associated with one or more metrics of standing or walking and were therefore included as covariates. Tukey's post-hoc testing was used to compare factor means of significant models.||||||0.01|||||||ANOVA|||We hypothesized a significant effect of intervention type on absolute change in dual task postural sway speed from baseline to immediately post intervention.||||0.01
72446974|NCT04295798|144411208|EQUIVALENCE|Model effects included stimulation condition (i.e., gel-tDCS, sponge-tDCS, gel-sham and sponge-sham), time (pre-, post-stimulation), and their interaction. Previous studies showed age, sex, and BMI were associated with one or more metrics of standing or walking and were therefore included as covariates. Tukey's post-hoc testing was used to compare factor means of significant models.||||||0.39|||||||ANOVA|||We hypothesized no significant effect of intervention type on absolute change in single task postural sway area from baseline to immediately post intervention||||0.39
72446975|NCT04295798|144411209|EQUIVALENCE|Model effects included stimulation condition (i.e., gel-tDCS, sponge-tDCS, gel-sham and sponge-sham), time (pre-, post-stimulation), and their interaction. Previous studies showed age, sex, and BMI were associated with one or more metrics of standing or walking and were therefore included as covariates. Tukey's post-hoc testing was used to compare factor means of significant models.||||||0.18|||||||ANOVA|||We hypothesized a significant effect of intervention type on absolute change in dual task postural sway area from baseline to immediately post intervention.||||0.18
72498074|NCT02116621|144526579|SUPERIORITY||Adjusted difference in differences|-1.24|||||TWO_SIDED|95.0|-2.77|0.3|||||Adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control) from baseline to 52 weeks.|||0.30|-2.77|
72498075|NCT02116621|144526580|SUPERIORITY||Adjusted difference in differences|-0.26|||||TWO_SIDED|95.0|-1.61|1.09|||||Adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control) from baseline to 52 weeks.|||1.09|-1.61|
72498076|NCT02116621|144526581|SUPERIORITY||Adjusted difference in differences|0.76|||||TWO_SIDED|95.0|-1.19|2.7|||||Adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control) from baseline to 52 weeks.|||2.70|-1.19|
72498077|NCT02116621|144526582|SUPERIORITY||Adjusted difference in differences|0.08|||||TWO_SIDED|95.0|-3.61|3.77|||||Adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control) from baseline to 52 weeks.|||3.77|-3.61|
72498078|NCT02116621|144526583|SUPERIORITY||Adjusted difference in differences|-1.91|||||TWO_SIDED|95.0|-9.07|5.26|||||Adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control) from baseline to 52 weeks.|||5.26|-9.07|
72498079|NCT02116621|144526584|SUPERIORITY||Adjusted difference in differences|1.53|||||TWO_SIDED|95.0|-2.7|5.77|||||Adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control) from baseline to 52 weeks.|||5.77|-2.70|
72446976|NCT04908722|144411244|NON_INFERIORITY|Tested using 97.5% confidence interval approach. The non-inferiority margin was 0.67.|Geometric mean ratio|1.15|||||TWO_SIDED|97.5|0.926|1.44||||||Group 1 (1 dose) vs Group 3 (1 dose)||1.440|0.926|
72446977|NCT04908722|144411244|NON_INFERIORITY|Tested using 97.5% confidence interval approach. The non-inferiority margin was 0.67.|Geometric mean ratio|0.8||||||97.5|0.641|1.0||||||Group 5 (1 dose) vs Group 3 (1 dose)||1.00|0.641|
72446978|NCT04908722|144411244|NON_INFERIORITY|Tested using 97.5% confidence interval approach. The non-inferiority margin was 0.67.|Geometric mean ratio|1.07|||||TWO_SIDED|97.5|0.844|1.356||||||Group 2 (1 dose) vs Group 3 (1 dose)||1.356|0.844|
72446979|NCT04908722|144411244|NON_INFERIORITY|Tested using 97.5% confidence interval approach. The non-inferiority margin was 0.67.|Geometric mean ratio|0.94|||||TWO_SIDED|97.5|0.742|1.193||||||Group 4 (1 dose) vs Group 3 (1 dose)||1.193|0.742|
72446980|NCT04908722|144411244|NON_INFERIORITY|Tested using 97.5% confidence interval approach. The non-inferiority margin was 0.67.|Geometric mean ratio|0.81|||||TWO_SIDED|97.5|0.648|1.007||||||Group 6 (1 dose) vs Group 3 (1 dose)||1.007|0.648|
72446981|NCT04908722|144411245|NON_INFERIORITY|Testing according to sequential non-inferiority assessment hypothesis. Tested using 97.5% confidence interval approach. The non-inferiority margin was 0.67.|Geometric mean ratio|2.53|||||TWO_SIDED|97.5|1.992|3.207||||||Group 1 (2 doses) vs Group 3 (1 dose)||3.207|1.992|
72446982|NCT04908722|144411245|NON_INFERIORITY|Testing according to sequential non-inferiority assessment hypothesis. Tested using 97.5% confidence interval approach. The non-inferiority margin was 0.67.|Geometric mean ratio|1.41|||||TWO_SIDED|97.5|1.088|1.815||||||Group 1 (2 doses) vs Group 3 (2 doses)||1.815|1.088|
72446983|NCT04908722|144411245|NON_INFERIORITY|Testing according to sequential non-inferiority assessment hypothesis. Tested using 97.5% confidence interval approach. The non-inferiority margin was 0.67.|Geometric mean ratio|1.79|||||TWO_SIDED|97.5|1.408|2.265||||||Group 5 (2 doses) vs Group 3 (1 dose)||2.265|1.408|
72446984|NCT04908722|144411245|NON_INFERIORITY|Testing according to sequential non-inferiority assessment hypothesis. Tested using 97.5% confidence interval approach. The non-inferiority margin was 0.67.|Geometric mean ratio|0.99|||||TWO_SIDED|97.5|0.769|1.282||||||Group 5 (2 doses) vs Group 3 (2 doses)||1.282|0.769|
72446985|NCT04908722|144411245|NON_INFERIORITY|Testing according to sequential non-inferiority assessment hypothesis. Tested using 97.5% confidence interval approach. The non-inferiority margin was 0.67.|Geometric mean ratio|2.37|||||TWO_SIDED|97.5|1.829|3.007||||||Group 2 (2 doses) vs Group 3 (1 dose)||3.007|1.829|
72446986|NCT04908722|144411245|NON_INFERIORITY|Testing according to sequential non-inferiority assessment hypothesis. Tested using 97.5% confidence interval approach. The non-inferiority margin was 0.67.|Geometric mean ratio|1.32|||||TWO_SIDED|97.5|1.0|1.739||||||Group 2 (2 doses) vs Group 3 (2 doses)||1.739|1.000|
72446987|NCT04908722|144411245|NON_INFERIORITY|Testing according to sequential non-inferiority assessment hypothesis. Tested using 97.5% confidence interval approach. The non-inferiority margin was 0.67.|Geometric mean ratio|2.2|||||TWO_SIDED|97.5|1.697|2.841||||||Group 4 (2 doses) vs Group 3 (1 dose)||2.841|1.697|
72498080|NCT02116621|144526585|SUPERIORITY||Adjusted difference in differences|4.13|||||TWO_SIDED|95.0|-6.81|15.07|||||Adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control) from baseline to 52 weeks.|||15.07|-6.81|
72498081|NCT02116621|144526586|SUPERIORITY||Adjusted difference in differences|1.0|||||TWO_SIDED|95.0|-4.11|6.11|||||Adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control) from baseline to 52 weeks.|||6.11|-4.11|
72446988|NCT04908722|144411245|NON_INFERIORITY|Testing according to sequential non-inferiority assessment hypothesis. Tested using 97.5% confidence interval approach. The non-inferiority margin was 0.67.|Geometric mean ratio|1.22|||||TWO_SIDED|97.5|0.928|1.606||||||Group 4 (2 doses) vs Group 3 (2 doses)||1.606|0.928|
72446989|NCT04908722|144411245|NON_INFERIORITY|Testing according to sequential non-inferiority assessment hypothesis. Tested using 97.5% confidence interval approach. The non-inferiority margin was 0.67.|Geometric mean ratio|1.7|||||TWO_SIDED|97.5|1.348|2.148||||||Group 6 (2 doses) vs Group 3 (1 dose)||2.148|1.348|
72446990|NCT04908722|144411245|NON_INFERIORITY|Testing according to sequential non-inferiority assessment hypothesis. Tested using 97.5% confidence interval approach. The non-inferiority margin was 0.67.|Geometric mean ratio|0.95|||||TWO_SIDED|97.5|0.736|1.217||||||Group 6 (2 doses) vs Group 3 (2 doses)||1.217|0.736|
72446991|NCT02319759|144411255|SUPERIORITY||Percent difference|39.7|||<|0.001|TWO_SIDED|95.0|25.3|54.1|||Cochran-Mantel-Haenszel|||||54.1|25.3|<0.001
72446992|NCT02319759|144411256|SUPERIORITY||Percentage (%) Difference|66.1|||<|0.001|TWO_SIDED|95.0|53.8|78.4|||Cochran-Mantel-Haenszel|||||78.4|53.8|<0.001
72446993|NCT02319759|144411257|SUPERIORITY||Least Square Mean Difference|-0.31|||<|0.001|TWO_SIDED|95.0|-0.471|-0.148|||MMRM|MMRM stands for Mixed-effects Model Repeated Measures||||-0.148|-0.471|<0.001
72446994|NCT03131154|144411299|OTHER||Hazard Ratio (HR)|1.129|||||TWO_SIDED|95.0|0.643|1.982|||||Cox proportional hazards model|||1.982|0.643|
72446995|NCT03131154|144411300|OTHER||Hazard Ratio (HR)|2.619|||||TWO_SIDED|95.0|0.989|6.939|||||Cox proportional hazards model|||6.939|0.989|
72446996|NCT06424236|144411301|SUPERIORITY||Least square (LS) mean|-0.1166|STANDARD_DEVIATION|0.29505||0.0117|TWO_SIDED|95.0|-0.206|-0.0272|||Mixed Model for Repeated Measures (MMRM)|||Week 52: Treatment group and visit were treated as categorical fixed effects factors and OLE baseline Composite \[11C\] PiB-PET SUVR score as continuous. An unstructured correlation pattern was used to estimate the variance-covariance of the within participant repeated measures. The Kenward-Roger method was used to estimate the denominator degrees of freedom.||-0.0272|-0.2060|0.0117
72561372|NCT03538262|144653363|OTHER|||||||0.2|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 3||||0.200
72446997|NCT06424236|144411301|OTHER||LS mean|-0.4648|STANDARD_DEVIATION|0.46591|<|0.0001|TWO_SIDED|95.0|-0.5971|-0.3326|||MMRM|||Week 104: Treatment group and visit were treated as categorical fixed effects factors and OLE baseline Composite \[11C\] PiB-PET SUVR score as continuous. An unstructured correlation pattern was used to estimate the variance-covariance of the within participant repeated measures. The Kenward-Roger method was used to estimate the denominator degrees of freedom.||-0.3326|-0.5971|<0.0001
72446998|NCT06424236|144411301|OTHER||LS mean|-0.7062|STANDARD_DEVIATION|0.43787|<|0.0001|TWO_SIDED|95.0|-0.8821|-0.5303|||MMRM|||Week 156: Treatment group and visit were treated as categorical fixed effects factors and OLE baseline Composite \[11C\] PiB-PET SUVR score as continuous. An unstructured correlation pattern was used to estimate the variance-covariance of the within participant repeated measures. The Kenward-Roger method was used to estimate the denominator degrees of freedom.||-0.5303|-0.8821|<0.0001
72446999|NCT06424236|144411302|SUPERIORITY|Recurrent progression was defined as any progression which was either the first increase in CDR-SB above baseline or any progression above the highest preceding post-baseline value identified as a progression, where progression above the preceding value must be observed at 2 consecutive measurements unless the progression occurs at the last measurement.|Hazard Ratio (HR)|1.32||||0.4535|TWO_SIDED|95.0|0.64|2.7|||Regression, Cox|||The time to recurrent progression in CDR - sum of boxes. Baseline Asymptomatic Participants: Estimate and confidence interval was based on the Cox proportional hazards regression model including treatment and baseline estimated years to symptom onset as fixed effects. The OLE gantenerumab mITT analysis set included all participants in the OLE who met mITT criteria using OLE baseline as the baseline reference point.||2.70|0.64|0.4535
72447000|NCT06424236|144411302|OTHER|Recurrent progression was defined as any progression which was either the first increase in CDR-SB above baseline or any progression above the highest preceding post-baseline value identified as a progression, where progression above the preceding value must be observed at 2 consecutive measurements unless the progression occurs at the last measurement.|Hazard Ratio (HR)|1.18||||0.4848|TWO_SIDED|95.0|0.74|1.86|||Regression, Cox|||The time to recurrent progression in CDR - sum of boxes. Baseline Symptomatic Participants: Estimate and confidence interval was based on the Cox proportional hazards regression model including treatment and baseline estimated years to symptom onset as fixed effects. The OLE gantenerumab mITT analysis set included all participants in the OLE who met mITT criteria using OLE baseline as the baseline reference point.||1.86|0.74|0.4848
72447001|NCT06424236|144411303|OTHER||Hazard Ratio (HR)|0.93||||0.8855|TWO_SIDED|95.0|0.33|2.58|||Regression, Cox|||Time to first progression in CDR-Global score. Baseline Asymptomatic Participants: Estimate and confidence interval was based on Cox proportional hazards regression model including treatment and baseline estimated years to symptom onset as fixed effects. Time to first progression was defined as time from baseline to first visit where CDR-Global Score was greater than baseline value, where progression must be observed at 2 consecutive measurements unless progression occurs at last measurement.||2.58|0.33|0.8855
72447002|NCT06424236|144411303|OTHER||Hazard Ratio (HR)|0.72||||0.4497|TWO_SIDED|95.0|0.3|1.69|||Regression, Cox|||Time to first progression in CDR-Global score. Baseline Symptomatic Participants: Estimate and confidence interval was based on Cox proportional hazards regression model including treatment and baseline estimated years to symptom onset as fixed effects. Time to first progression was defined as time from baseline to first visit where CDR-Global Score was greater than baseline value, where progression must be observed at 2 consecutive measurements unless progression occurs at last measurement.||1.69|0.30|0.4497
72447003|NCT06424236|144411304|SUPERIORITY||LS mean|-0.06|STANDARD_ERROR_OF_MEAN|0.2||0.76|TWO_SIDED|95.0|-0.46|0.33|||Linear Mixed Effects Model||Estimated value is the difference in the rate of change between the treatment group and control group.|Baseline Asymptomatic Participants: The statistical model included time since baseline (years), treatment arm, an interaction between treatment and time. Time was considered as continuous. Random intercepts and slopes for each participant was included as random effects with compound symmetry covariance matrix.||0.33|-0.46|0.760
72561373|NCT03538262|144653363|OTHER|||||||0.888|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 6||||0.888
72561374|NCT03538262|144653363|OTHER|||||||0.837|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 9||||0.837
72561375|NCT03538262|144653363|OTHER|||||||0.394|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 12||||0.394
72447004|NCT06424236|144411304|OTHER||LS mean|-1.21|STANDARD_ERROR_OF_MEAN|0.715||0.093|TWO_SIDED|95.0|-2.63|0.2|||Linear Mixed Effects Model||Estimated value is the difference in the rate of change between the treatment group and control group.|Baseline Symptomatic Participants: The statistical model included time since baseline (years), treatment arm, an interaction between treatment and time. Time was considered as continuous. Random intercepts and slopes for each participant was included as random effects with an unstructured covariance matrix.||0.20|-2.63|0.093
72447005|NCT06424236|144411305|OTHER||LS mean|0.0|STANDARD_ERROR_OF_MEAN|0.22||0.989|TWO_SIDED|95.0|-0.43|0.44|||Linear Mixed Effects Model||Estimated value is the difference in the rate of change between the treatment group and control group.|Baseline Asymptomatic Participants: The statistical model included time since baseline (years), treatment arm, an interaction between treatment and time. Time was considered as continuous. Random intercepts and slopes for each participant was included as random effects with an unstructured covariance matrix.||0.44|-0.43|0.989
72447006|NCT06424236|144411305|OTHER||LS mean|0.2|STANDARD_ERROR_OF_MEAN|0.533||0.714|TWO_SIDED|95.0|-0.86|1.25|||Linear Mixed Effects Model||Estimated value is the difference in the rate of change between the treatment group and control group.|Baseline Symptomatic Participants: The statistical model included time since baseline (years), treatment arm, an interaction between treatment and time. Time was considered as continuous. Random intercepts and slopes for each participant was included as random effects with an unstructured covariance matrix.||1.25|-0.86|0.714
72447007|NCT06424236|144411306|OTHER||LS mean|-0.03|STANDARD_ERROR_OF_MEAN|0.077||0.738|TWO_SIDED|95.0|-0.18|0.13|||Linear Mixed Effects Model||Estimated value is the difference in the rate of change between the treatment group and control group.|Baseline Asymptomatic Participants: The statistical model included time since baseline (years), treatment arm, an interaction between treatment and time. Time was considered as continuous. Random intercepts and slopes for each participant was included as random effects with an unstructured covariance matrix.||0.13|-0.18|0.738
72447008|NCT06424236|144411306|OTHER||LS mean|0.19|STANDARD_ERROR_OF_MEAN|0.222||0.395|TWO_SIDED|95.0|-0.28|0.66|||Linear Mixed Effects Model||Estimated value is the difference in the rate of change between the treatment group and control group.|Baseline Symptomatic Participants: The statistical model included time since baseline (years), treatment arm, an interaction between treatment and time. Time was considered as continuous. Random intercepts and slopes for each participant was included as random effects with an unstructured covariance matrix.||0.66|-0.28|0.395
72447009|NCT06424236|144411307|OTHER||LS mean|-2.176|STANDARD_DEVIATION|2.89551|<|0.0001|TWO_SIDED|95.0|-2.9469|-1.4051|||MMRM|||Week 56: Treatment group and visit were treated as categorical fixed effects factors and OLE baseline CSF pTau181 as continuous. An unstructured correlation pattern was used to estimate the variance-covariance of the within participant repeated measures. The Kenward-Roger method was used to estimate the denominator degrees of freedom.||-1.4051|-2.9469|<0.0001
72447010|NCT06424236|144411307|OTHER||LS mean|-4.8434|STANDARD_DEVIATION|3.78771|<|0.0001|TWO_SIDED|95.0|-5.8609|-3.826|||MMRM|||Week 104: Treatment group and visit were treated as categorical fixed effects factors and OLE baseline CSF pTau181 as continuous. An unstructured correlation pattern was used to estimate the variance-covariance of the within participant repeated measures. The Kenward-Roger method was used to estimate the denominator degrees of freedom.||-3.8260|-5.8609|<0.0001
72447011|NCT06424236|144411307|OTHER||LS mean|-5.762|STANDARD_DEVIATION|3.31129|<|0.0001|TWO_SIDED|95.0|-6.9679|-4.5561|||MMRM|||Week 156: Treatment group and visit were treated as categorical fixed effects factors and OLE baseline CSF pTau181 as continuous. An unstructured correlation pattern was used to estimate the variance-covariance of the within participant repeated measures. The Kenward-Roger method was used to estimate the denominator degrees of freedom.||-4.5561|-6.9679|<0.0001
72447012|NCT06424236|144411308|OTHER||LS mean|0.04|STANDARD_ERROR_OF_MEAN|0.022||0.055|TWO_SIDED|95.0|0.0|0.09|||Linear Mixed Effects Model||Estimated value is the difference in the rate of change between the treatment group and control group.|Baseline Asymptomatic Participants: The statistical model included time since baseline (years), treatment arm, an interaction between treatment and time. Time was considered as continuous. Random intercepts and slopes for each participant was included as random effects with variance components covariance matrix.||0.09|0.00|0.055
72447013|NCT06424236|144411308|OTHER||LS mean|0.04|STANDARD_ERROR_OF_MEAN|0.034||0.188|TWO_SIDED|95.0|-0.02|0.11|||Linear Mixed Effects Model||Estimated value is the difference in the rate of change between the treatment group and control group.|Baseline Symptomatic Participants: The statistical model included time since baseline (years), treatment arm, an interaction between treatment and time. Time was considered as continuous. Random intercepts and slopes for each participant was included as random effects with an unstructured covariance matrix.||0.11|-0.02|0.188
72447014|NCT06424236|144411309|OTHER||LS mean|0.0067|STANDARD_DEVIATION|0.0124||0.0001|TWO_SIDED|95.0|0.0034|0.01|||MMRM|||Week 52: Treatment group and visit were treated as categorical fixed effects factors and OLE baseline CSF Amyloid Beta1-42/40 score as continuous. An unstructured correlation pattern was used to estimate the variance-covariance of the within participant repeated measures. The Kenward-Roger method was used to estimate the denominator degrees of freedom.||0.0100|0.0034|0.0001
72498082|NCT02116621|144526587|SUPERIORITY||Adjusted difference in differences|1.11|||||TWO_SIDED|95.0|-5.27|7.48|||||Adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control) from baseline to 52 weeks.|||7.48|-5.27|
72498083|NCT02116621|144526588|SUPERIORITY||Mean Difference (Final Values)|9.41||||0.054|TWO_SIDED|95.0|-0.15|18.96|||Regression, Linear|||||18.96|-0.15|0.054
72447015|NCT06424236|144411309|OTHER||LS mean|0.0251|STANDARD_DEVIATION|0.02262|<|0.0001|TWO_SIDED|95.0|0.0189|0.0312|||MMRM|||Week 104: Treatment group and visit were treated as categorical fixed effects factors and OLE baseline CSF Amyloid Beta1-42/40 score as continuous. An unstructured correlation pattern was used to estimate the variance-covariance of the within participant repeated measures. The Kenward-Roger method was used to estimate the denominator degrees of freedom.||0.0312|0.0189|<0.0001
72498084|NCT02078219|144526622|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-29.28|||<|0.0001|TWO_SIDED|95.0|-36.99|-21.57|||ANCOVA, LOCF|||||-21.57|-36.99|<0.0001
72498085|NCT02078219|144526622|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-49.25|||<|0.0001|TWO_SIDED|95.0|-56.97|-41.52|||ANCOVA, LOCF|||||-41.52|-56.97|<0.0001
72498086|NCT02078219|144526622|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-53.33|||<|0.0001|TWO_SIDED|95.0|-61.0|-45.67|||ANCOVA, LOCF|||||-45.67|-61.00|<0.0001
72561376|NCT03538262|144653363|OTHER|||||||0.268|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 15||||0.268
72447016|NCT06424236|144411309|OTHER||LS mean|0.0357|STANDARD_DEVIATION|0.02467|<|0.0001|TWO_SIDED|95.0|0.0266|0.0447|||MMRM|||Week 156: Treatment group and visit were treated as categorical fixed effects factors and OLE baseline CSF Amyloid Beta1-42/40 score as continuous. An unstructured correlation pattern was used to estimate the variance-covariance of the within participant repeated measures. The Kenward-Roger method was used to estimate the denominator degrees of freedom.||0.0447|0.0266|<0.0001
72447017|NCT06424236|144411310|OTHER||LS mean|0.04|STANDARD_ERROR_OF_MEAN|0.081||0.644|TWO_SIDED|95.0|-0.12|0.2|||Linear Mixed Effects Model||Estimated value is the difference in the rate of change between the treatment group and control group.|Baseline Asymptomatic Participants: The statistical model included time since baseline (years), treatment arm, an interaction between treatment and time. Time was considered as continuous. Random intercepts and slopes for each participant was included as random effects with an unstructured covariance matrix.||0.20|-0.12|0.644
72447018|NCT06424236|144411310|OTHER||LS mean|0.04|STANDARD_ERROR_OF_MEAN|0.111||0.745|TWO_SIDED|95.0|-0.18|0.26|||Linear Mixed Effects Model||Estimated value is the difference in the rate of change between the treatment group and control group.|Baseline Symptomatic Participants: The statistical model included time since baseline (years), treatment arm, an interaction between treatment and time. Time was considered as continuous. Random intercepts and slopes for each participant was included as random effects with an unstructured covariance matrix.||0.26|-0.18|0.745
72447019|NCT04213872|144411311|OTHER|||||||0.01|||||||t-test, 2 sided|||"Measure Pre-MM mean (sd) Post-MM mean (sd) Pre/Post MM mean (sd) difference P-Value CogPCI 25.4 (14.2) 17.3 (10.5) \*-8.1 (3.7) .01~\*reduction in scores indicate improvement."||||.01
72447020|NCT04213872|144411312|OTHER|||||||0.03|||||||t-test, 2 sided|||Measure Pre-MM mean (sd) Post-MM mean (sd) Pre/Post MM mean (sd) difference P-Value CogPCA 16.0 (5.1) 19.2 (5.3) 3.2 (0.2) .03||||.03
72447021|NCT04213872|144411313|OTHER|||||||0.04|||||||t-test, 2 sided|||"Measure Pre-MM mean (sd) Post-MM mean (sd) Pre/Post MM mean (sd) difference P-Value CogQOL 3.7 (3.8) 1.8 (2.2) \*-1.9 (1.6) .04~\*lower scores signifying better outcomes."||||.04
72447022|NCT04213872|144411314|OTHER|||||||0.04|||||||t-test, 2 sided|||"Measure Pre-MM mean (sd) Post-MM mean (sd) Pre/Post MM mean (sd) difference P-Value CogOth 1.5 (2.1) 0.2 (0.4) \*-1.3 (1.7) .04~\*lower scores signifying better outcomes."||||.04
72447023|NCT04213872|144411315|OTHER|||||||0.01|||||||t-test, 2 sided|||Measure Pre-MM mean (sd) Post-MM mean (sd) Pre/Post MM mean (sd) difference P-Value WAIS-III Letter/Number 10.7 (3.2) 12.7 (2.8) 2.0 (0.4) .01||||.01
72447024|NCT04213872|144411316|OTHER|||||||0.6|||||||t-test, 2 sided|||"Measure Pre-MM mean (sd) Post-MM mean (sd) Pre/Post MM mean (sd) difference P-Value~WAIS-III Digit Span Forward and Backward 19.2 (4.8) 19.7 (4.4) 0.5 (0.4) .60"||||.60
72498087|NCT02761967|144526631|EQUIVALENCE|The statistical power of the study for the temporal variables was 82%. Multiple linear regression models were obtained for the first and second stages and for the total duration of delivery.||||||0.776|||||||Chi-squared|||||||0.776
72498088|NCT03136107|144526641|EQUIVALENCE|Statistical criterion defined in ISO 24444:2010 is that the 95 %CI is within ±17 % of the mean SPF||||||||||||||||CI % values (which is the percentage that half the 95 % CI represents of the mean values).|Test product CI of ±16.4% and reference product CI of ±16.6% of the mean SPF.|||
72498089|NCT02292771|144526650|SUPERIORITY||Mean Difference (Final Values)|-1.2||||0.3797|TWO_SIDED|95.0|-8.879|6.479|||Finite mixture model|||||6.479|-8.879|0.3797
72498090|NCT02292771|144526651|SUPERIORITY||Odds Ratio (OR)|1.0||||0.952|TWO_SIDED|95.0|0.44|2.18|||Regression, Logistic|||||2.18|0.44|0.9520
72447025|NCT04213872|144411317|OTHER|||||||0.03|||||||t-test, 2 sided|||"Measure Pre-MM mean (sd) Post-MM mean (sd) Pre/Post MM mean (sd) difference P-Value PSQI 1.5 (0.8) 0.9 (0.7) \*-0.6 (0.1) .03~\*Lower scores mean better outcomes."||||.03
72447026|NCT04213872|144411318|OTHER|||||||0.05|||||||t-test, 2 sided|||"Measure Pre-MM mean (sd) Post-MM mean (sd) Pre/Post MM mean (sd) difference P-Value POMS Anxiety 9.2 (7.7) 4.2 (3.7) \*-5.0 (4.0) .05~\*Lower scores mean better outcomes."||||.05
72447027|NCT04213872|144411319|OTHER|||||||0.08|||||||t-test, 2 sided|||"Measure Pre-MM mean (sd) Post-MM mean (sd) Pre/Post MM mean (sd) difference P-Value POMS Depression 4.1 (4.9) 2.0 (3.0) \*-2.1 (1.9) .08~\*Lower scores mean better outcomes."||||.08
72447028|NCT04213872|144411320|OTHER|||||||0.3|||||||t-test, 2 sided|||"Measure Pre-MM mean (sd) Post-MM mean (sd) Pre/Post MM mean (sd) difference P-Value BDNF 0.11 (0.9) 0.30 (0.7) 0.19 (0.2) .30~Higher scores mean better outcomes."||||.30
72447029|NCT04213872|144411321|OTHER|||||||0.8|||||||t-test, 2 sided|||"Measure Pre-MM mean (sd) Post-MM mean (sd) Pre/Post MM mean (sd) difference P-Value NF-kB1 171.7 (25.4) 173.7 (21.6) 2.0 (3.8) .80~Higher scores mean better outcomes."||||.80
72447030|NCT04213872|144411322|OTHER|||||||0.61|||||||t-test, 2 sided|||Measure Pre-MM mean (sd) Post-MM mean (sd) Pre/Post MM mean (sd) difference P-Value TP53 12.3 (2.7) 13.1 (5.5) 0.8 (2.8) .61||||.61
72447031|NCT03339713|144411323|NON_INFERIORITY|Non-inferiority of Group 2 versus Group 1 in terms of the HI antibody titers against all four influenza vaccine strains 28 days after the administration of influenza vaccine, using a non-inferiority margin of 2 for the GMT ratio (Group 2 / Group 1).|Geometric Mean Ratio|0.8|||<|0.001|TWO_SIDED|90.0|0.55|1.11|||t-test, 1 sided|||A/Michigan strain: Based on Welch-Satterthwaite t-interval method. The difference (Group 2 minus Group 1) and CI in log-transformed HI antibody titers were calculated for each of the 4 influenza vaccine strains, and were back-transformed (by exponentiation) to a GMT ratio (Group 2 / Group 1) and the corresponding CI.||1.11|0.55|<.001
72447032|NCT03339713|144411323|NON_INFERIORITY|Non-inferiority of Group 2 versus Group 1 in terms of the HI antibody titers against all four influenza vaccine strains 28 days after the administration of influenza vaccine, using a non-inferiority margin of 2 for the GMT ratio (Group 2 / Group 1).|Geometric Mean Ratio|0.8|||<|0.001|TWO_SIDED|90.0|0.59|1.12|||t-test, 1 sided|||A/Hong Kong strain: Based on Welch-Satterthwaite t-interval method. The difference (Group 2 minus Group 1) and CI in log-transformed HI antibody titers were calculated for each of the 4 influenza vaccine strains, and were back-transformed (by exponentiation) to a GMT ratio (Group 2 / Group 1) and the corresponding CI.||1.12|0.59|<.001
72498091|NCT02292771|144526652|SUPERIORITY||Odds Ratio (OR)|1.0||||0.952|TWO_SIDED|95.0|0.46|2.29|||Regression, Logistic|||||2.29|0.46|0.9520
72498092|NCT02292771|144526653|SUPERIORITY||Ratio|1.14|STANDARD_ERROR_OF_MEAN|0.222||0.5672|TWO_SIDED|95.0|0.73|1.76|||ANCOVA|||||1.76|0.73|0.5672
72498093|NCT02292771|144526654|SUPERIORITY||Odds Ratio (OR)|1.9||||0.5066|TWO_SIDED|95.0|0.3|11.71|||Regression, Logistic|||||11.71|0.30|0.5066
72498094|NCT02292771|144526660|SUPERIORITY||Odds Ratio (OR)|0.8||||0.779|TWO_SIDED|95.0|0.12|4.84|||Regression, Logistic|||||4.84|0.12|0.7790
72447033|NCT03339713|144411323|NON_INFERIORITY|Non-inferiority of Group 2 versus Group 1 in terms of the HI antibody titers against all four influenza vaccine strains 28 days after the administration of influenza vaccine, using a non-inferiority margin of 2 for the GMT ratio (Group 2 / Group 1).|Geometric Mean Ratio|1.0|||<|0.001|TWO_SIDED|90.0|0.77|1.34|||t-test, 1 sided|||B/Brisbane strain: Based on Welch-Satterthwaite t-interval method. The difference (Group 2 minus Group 1) and CI in log-transformed HI antibody titers were calculated for each of the 4 influenza vaccine strains, and were back-transformed (by exponentiation) to a GMT ratio (Group 2 / Group 1) and the corresponding CI.||1.34|0.77|<.001
72498095|NCT02292771|144526661|SUPERIORITY||Odds Ratio (OR)|1.2||||0.6646|TWO_SIDED|95.0|0.51|2.9|||Regression, Logistic|||||2.90|0.51|0.6646
72498096|NCT02292771|144526662|SUPERIORITY||Odds Ratio (OR)|2.3||||0.1432|TWO_SIDED|95.0|0.75|7.24|||Regression, Logistic|||||7.24|0.75|0.1432
72498097|NCT02292771|144526663|SUPERIORITY||Odds Ratio (OR)|1.5||||0.525|TWO_SIDED|95.0|0.43|5.15|||Regression, Logistic|||||5.15|0.43|0.5250
72498098|NCT02292771|144526664|SUPERIORITY||Odds Ratio (OR)|0.6||||0.4682|TWO_SIDED|95.0|0.13|2.58|||Regression, Logistic|||||2.58|0.13|0.4682
72498099|NCT04025632|144526692|SUPERIORITY||Wilcoxon-Mann-Whitney odds|0.55||||0.464|TWO_SIDED|95.0|0.19|1.57||Conducted using a 2-sided Van Elteren test, which represents an extension of the Wilcoxon rank sum test for comparing 2 treatments in a stratified experiment using within-stratum ranks assigning greater weight to rank sums from smaller strata.|2-sided Van Elteren test||The magnitude of association between treatment groups was expressed as in Wilcoxon-Mann-Whitney odds followed by the 95% confidence intervals.|||1.57|0.19|0.464
72390376|NCT04115839|144288574|SUPERIORITY||Difference in response rates|15.4||||0.098|TWO_SIDED|95.0|-5.5|36.3||P-value was calculated from the logistic regression with treatment groups and stratification factors (geographic region, concurrent use of csDMARD(s) and/or apremilast at randomization, prior use of bioDMARD(s)) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 2||36.3|-5.5|0.098
72498100|NCT04025632|144526694|SUPERIORITY||Odds Ratio (OR)|1.088||||0.919|TWO_SIDED|95.0|0.214|5.535||P-value for the comparison of treatment groups was calculated using logistic regression with investigational medicinal product and strata as fixed factors.|Regression, Logistic|||||5.535|0.214|0.919
72498101|NCT04025632|144526695|SUPERIORITY||Least squares (LS) mean difference|-0.688||||0.496|TWO_SIDED|95.0|-2.781|1.404||Based on a linear model with treatment and strata (anti-3-hydroxy-3-methyl-glutaryl-coenzyme A reductase \[HMGCR\]+/anti-signal recognition particle \[SRP\]+) as fixed factors with Baseline 3TUG as a covariate.|Linear Mixed Effect Model||The difference presented is zilucoplan 0.3 mg/kg minus placebo.|||1.404|-2.781|0.496
72498102|NCT04025632|144526696|SUPERIORITY||LS mean difference|3.89||||0.431|TWO_SIDED|95.0|-6.18|13.95||Based on a linear model with treatment and strata (anti-HMGCR+/anti-SRP+) as fixed factors with Baseline proximal MMT as a covariate.|Linear Mixed Effect Model||The difference presented is zilucoplan 0.3 mg/kg minus placebo.|||13.95|-6.18|0.431
72498103|NCT04025632|144526697|SUPERIORITY||LS mean difference|-0.204||||0.8|TWO_SIDED|95.0|-1.855|1.448||Based on a linear model with treatment and strata (anti-HMGCR+/anti-SRP+) as fixed factors with Baseline Physician Global Activity VAS as a covariate.|Linear Mixed Effect Model||The difference presented is zilucoplan 0.3 mg/kg minus placebo.|||1.448|-1.855|0.800
72498104|NCT04025632|144526698|SUPERIORITY||LS mean difference|-1.281||||0.221|TWO_SIDED|95.0|-3.39|0.829||Based on a linear model with treatment and strata (anti-HMGCR+/anti-SRP+) as fixed factors with Baseline Patient Global Activity VAS as a covariate.|Linear Mixed Effect Model||The difference presented is zilucoplan 0.3 mg/kg minus placebo.|||0.829|-3.390|0.221
72498105|NCT04025632|144526699|SUPERIORITY||LS mean difference|-0.147||||0.508|TWO_SIDED|95.0|-0.601|0.307||Based on a linear model with treatment and strata (anti-HMGCR+/anti-SRP+) as fixed factors with Baseline HAQ as a covariate.|Linear Mixed Effect Model||The difference presented is zilucoplan 0.3 mg/kg minus placebo.|||0.307|-0.601|0.508
72498106|NCT04025632|144526700|SUPERIORITY||LS mean difference|-0.143||||0.765|TWO_SIDED|95.0|-1.123|0.837|||Linear Mixed Effect Model|Based on a linear model with treatment and strata (anti-HMGCR+/anti-SRP+) as fixed factors with Baseline MDAAT as a covariate.|The difference presented is zilucoplan 0.3 mg/kg minus placebo.|||0.837|-1.123|0.765
72390377|NCT04115839|144288574|SUPERIORITY||Difference in response rates|-5.1||||0.4|TWO_SIDED|95.0|-21.1|11.0||P-value was calculated from the logistic regression with treatment groups and stratification factors (geographic region, concurrent use of csDMARD(s) and/or apremilast at randomization, prior use of bioDMARD(s)) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 2||11.0|-21.1|0.40
72390378|NCT04115839|144288574|SUPERIORITY||Difference in response rates|10.8||||0.26|TWO_SIDED|95.0|-12.6|34.3||P-value was calculated from the logistic regression with treatment groups and stratification factors (geographic region, concurrent use of csDMARD(s) and/or apremilast at randomization, prior use of bioDMARD(s)) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||34.3|-12.6|0.26
72390379|NCT04115839|144288574|SUPERIORITY||Difference in response rates|8.8||||0.39|TWO_SIDED|95.0|-14.6|32.2||P-value was calculated from the logistic regression with treatment groups and stratification factors (geographic region, concurrent use of csDMARD(s) and/or apremilast at randomization, prior use of bioDMARD(s)) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||32.2|-14.6|0.39
72390380|NCT04115839|144288574|SUPERIORITY||Difference in response rates|20.0||||0.088|TWO_SIDED|95.0|-6.9|46.9||P-value was calculated from the logistic regression with treatment groups and stratification factors (geographic region, concurrent use of csDMARD(s) and/or apremilast at randomization, prior use of bioDMARD(s)) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 8||46.9|-6.9|0.088
72390381|NCT04115839|144288574|SUPERIORITY||Difference in response rates|-7.0||||0.49|TWO_SIDED|95.0|-32.9|18.9||P-value was calculated from the logistic regression with treatment groups and stratification factors (geographic region, concurrent use of csDMARD(s) and/or apremilast at randomization, prior use of bioDMARD(s)) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 8||18.9|-32.9|0.49
72447034|NCT03339713|144411323|NON_INFERIORITY|Non-inferiority of Group 2 versus Group 1 in terms of the HI antibody titers against all four influenza vaccine strains 28 days after the administration of influenza vaccine, using a non-inferiority margin of 2 for the GMT ratio (Group 2 / Group 1).|Geometric Mean Ratio|1.0|||<|0.001|TWO_SIDED|90.0|0.76|1.36|||t-test, 1 sided|||B/Phuket strain: Based on Welch-Satterthwaite t-interval method. The difference (Group 2 minus Group 1) and CI in log-transformed HI antibody titers were calculated for each of the 4 influenza vaccine strains, and were back-transformed (by exponentiation) to a GMT ratio (Group 2 / Group 1) and the corresponding CI.||1.36|0.76|<.001
72447035|NCT01715285|144411349|SUPERIORITY||Hazard Ratio (HR)|0.466|||<|0.0001|TWO_SIDED|95.0|0.394|0.55|||Log Rank|||||0.550|0.394|<0.0001
72447036|NCT01715285|144411350|SUPERIORITY||Hazard Ratio (HR)|0.661|||<|0.0001|TWO_SIDED|95.0|0.564|0.775|||Log Rank|||||0.775|0.564|< 0.0001
72447037|NCT05505292|144411356|SUPERIORITY|||||||0.69|||||||Wilcoxon (Mann-Whitney)|||||||0.69
72447038|NCT05505292|144411357|SUPERIORITY|||||||0.66|||||||t-test, 2 sided|||||||0.66
72447039|NCT05505292|144411358|SUPERIORITY|||||||0.23|||||||t-test, 2 sided|||||||0.23
72447040|NCT05505292|144411359|SUPERIORITY|||||||0.84|||||||Wilcoxon (Mann-Whitney)|||||||0.84
72447041|NCT05505292|144411360|SUPERIORITY|||||||0.68|||||||Wilcoxon (Mann-Whitney)|||||||0.68
72447042|NCT05505292|144411361|SUPERIORITY|||||||0.14|||||||Chi-squared|||||||0.14
72447043|NCT05505292|144411362|SUPERIORITY|||||||0.62|||||||Wilcoxon (Mann-Whitney)|||Question 1a Change from baseline to week 8 in lifitegrast vs vehicle||||0.62
72447044|NCT05505292|144411362|SUPERIORITY|||||||0.53|||||||Wilcoxon (Mann-Whitney)|||Question 1b change from baseline to week 8 in lifitegrast vs vehicle groups||||0.53
72447045|NCT05505292|144411362|SUPERIORITY|||||||0.66|||||||Wilcoxon (Mann-Whitney)|||Question 2a change from baseline to week 8 in lifitegrast vs vehicle groups||||0.66
72561377|NCT03538262|144653363|OTHER|||||||0.039|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 18||||0.039
72447046|NCT05505292|144411362|SUPERIORITY|||||||0.81|||||||Wilcoxon (Mann-Whitney)|||Question 2b change from baseline to week 8 in lifitegrast vs vehicle groups||||0.81
72447047|NCT05505292|144411362|SUPERIORITY||||||>|0.999|||||||Wilcoxon (Mann-Whitney)|||Question 3a change from baseline to week 8 in lifitegrast vs vehicle groups||||>0.999
72447048|NCT05505292|144411362|SUPERIORITY|||||||0.47|||||||Wilcoxon (Mann-Whitney)|||Question 3b change from baseline to week 8 in lifitegrast vs vehicle groups||||0.47
72447049|NCT05505292|144411362|SUPERIORITY|||||||0.52|||||||Wilcoxon (Mann-Whitney)|||Question 4 change from baseline to week 8 in lifitegrast vs vehicle groups||||0.52
72447050|NCT05505292|144411362|SUPERIORITY|||||||0.69|||||||Wilcoxon (Mann-Whitney)|||Question 5 change from baseline to week 8 in lifitegrast vs vehicle groups||||0.69
72447051|NCT01073566|144411363|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Pre-study power calculations determined that 28 completed subjects provided 90% power to detect equivalence for the primary endpoint of MDBG of bolus-patch compared to pen/syringe using a 2-sided alpha level of 0.05, when the margin of equivalence for MDBG is 1.11 mmol/L, the true mean difference is 0.0, and the standard deviation of the differences is 1.72 mmol/L.|Mean Difference (Final Values)|-0.42|STANDARD_ERROR_OF_MEAN|0.24||0.098|TWO_SIDED|95.0|-0.97|0.16|||ANOVA||Finesse versus usual injection device.|A two-period, two-treatment crossover ANOVA model was used to compare devices for continuous measures.||0.16|-0.97|0.098
72447052|NCT01073566|144411364|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.49|STANDARD_ERROR_OF_MEAN|0.15||0.004|TWO_SIDED|95.0|-0.8|-0.17|||ANOVA||Finesse versus usual injection device|This was conducted at a 2-sided alpha level of 0.05 and confidence intervals (CI) were calculated at 95%, 2-sided. A two-period, two-treatment crossover ANOVA model was used to compare devices for continuous measures.||-0.17|-0.80|0.004
72447053|NCT01073566|144411365|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||McNemar|||Higher number is better. The answers were scored on a scale of 0-100 to standardize as described in the original papers.||||<0.001
72447054|NCT01389856|144411367|SUPERIORITY_OR_OTHER_LEGACY|||||||1|TWO_SIDED||||||Fisher Exact|||||||1
72447055|NCT01389856|144411368|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3407|TWO_SIDED||||||Log Rank|||||||0.3407
72447056|NCT01389856|144411369|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2399|TWO_SIDED||||||Log Rank|||||||0.2399
72447057|NCT01389856|144411371|SUPERIORITY_OR_OTHER_LEGACY|||||||1|TWO_SIDED||||||Fisher Exact|||||||1.000
72447058|NCT01389856|144411372|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2235|TWO_SIDED||||||Non-parametric ANCOVA|||||||0.2235
72447059|NCT01389856|144411373|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1468|TWO_SIDED||||||Non-parametric ANCOVA|||||||0.1468
72447060|NCT01389856|144411374|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0789|TWO_SIDED||||||Non-parametric ANCOVA|||||||0.0789
72447061|NCT01389856|144411375|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3723|TWO_SIDED||||||Non-parametric ANCOVA|||||||0.3723
72447062|NCT01389856|144411376|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0569|TWO_SIDED||||||Non-parametric ANCOVA|||||||0.0569
72447063|NCT01389856|144411377|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1015|TWO_SIDED||||||Non-parametric ANCOVA|||||||0.1015
72447064|NCT01389856|144411378|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0824|TWO_SIDED||||||Non-parametric ANCOVA|||||||0.0824
72447065|NCT01389856|144411379|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3863|TWO_SIDED||||||Non-parametric ANCOVA|||||||0.3863
72447066|NCT01389856|144411380|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3936|TWO_SIDED||||||Non-parametric ANCOVA|||||||0.3936
72447067|NCT01389856|144411381|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2436|TWO_SIDED||||||Non-parametric ANCOVA|||||||0.2436
72447068|NCT01389856|144411382|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1756|TWO_SIDED||||||Non-parametric ANCOVA|||||||0.1756
72447069|NCT01389856|144411383|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1155|TWO_SIDED||||||Non-parametric ANCOVA|||||||0.1155
72447070|NCT01389856|144411384|SUPERIORITY_OR_OTHER_LEGACY|||||||0.14|TWO_SIDED||||||Non-parametric ANCOVA|||||||0.1400
72447071|NCT05604508|144411401|OTHER||Odds Ratio (OR)|0.735|||||TWO_SIDED|95.0|0.347|1.553|||||Adjusted for age, gender, race, socioeconomic status, lifetime tobacco use, and baseline cigarette use intentions|||1.553|0.347|
72561378|NCT03538262|144653363|OTHER|||||||0.979|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 21||||0.979
72561379|NCT03538262|144653363|OTHER|||||||0.014|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 24||||0.014
72561380|NCT03538262|144653364|OTHER|||||||0.285|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 3||||0.285
72561381|NCT03538262|144653364|OTHER|||||||0.267|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 9||||0.267
72447072|NCT05604508|144411401|OTHER||Odds Ratio (OR)|0.471|||||TWO_SIDED|95.0|0.234|0.947|||||Adjusted for age, gender, race, socioeconomic status, lifetime tobacco use, and baseline cigarette use intentions.|||0.947|0.234|
72447073|NCT05604508|144411402|OTHER||Odds Ratio (OR)|1.503|||||TWO_SIDED|95.0|0.727|3.107|||||Adjusted for age, gender, race, socioeconomic status, lifetime tobacco use, baseline vaping intentions|||3.107|0.727|
72447074|NCT05604508|144411402|OTHER||Odds Ratio (OR)|0.878|||||TWO_SIDED|95.0|0.398|1.938|||||Adjusted for age, gender, race, socioeconomic status, lifetime tobacco use, baseline vaping intentions|||1.938|0.398|
72447075|NCT05604508|144411403|OTHER||Odds Ratio (OR)|0.619|||||TWO_SIDED|95.0|0.295|1.301|||||Adjusted for age, gender, race, socioeconomic status, lifetime tobacco use, and baseline smokeless use intentions|||1.301|0.295|
72447076|NCT05604508|144411403|OTHER||Odds Ratio (OR)|0.489|||||TWO_SIDED|95.0|0.237|1.006|||||Adjusted for age, gender, race, socioeconomic status, lifetime tobacco, baseline smokeless use intentions|||1.006|0.237|
72447077|NCT05604508|144411404|OTHER||Odds Ratio (OR)|1.428|||||TWO_SIDED|95.0|0.72|2.832|||||Adjusted for age, gender, race, socioeconomic status, lifetime tobacco use, baseline LCC use intentions|||2.832|0.720|
72447078|NCT05604508|144411404|OTHER||Odds Ratio (OR)|1.42|||||TWO_SIDED|95.0|0.681|2.96|||||Adjusted for age, gender, race, socioeconomic status, lifetime tobacco use, baseline LCC use intentions|||2.960|0.681|
72447079|NCT03461276|144411504|SUPERIORITY||||||<|0.0001|||||||t-test, 1 sided|A 1-sided t-test with a significance level of 0.025 was employed.||"The trial was considered successfully confirmatory regarding efficacy (immunogenicity) of ABvac40 if the average MΔ of anti-Aβ40 antibody signal (OD in ELISA) in the ABvac40 group was significantly greater than the average MΔ of anti-Aβ40 antibody signal in the Placebo group. i.e.~* Null hypothesis: average MΔ anti-Aβ40 (ABvac40) ≤ average MΔ anti-Aβ40 (placebo).~* Alternative hypothesis: average MΔ anti-Aβ40 (ABvac40) \> average MΔ anti-Aβ40 (placebo)."||||<0.0001
72447080|NCT03461276|144411504|SUPERIORITY|Additional test|||||<|0.0001||||||1-sided|Wilcoxon (Mann-Whitney)|||||||<0.0001
72447081|NCT03461276|144411504|SUPERIORITY||Mean Difference (Final Values)|3.15|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001|TWO_SIDED|95.0|2.96|3.34|||ANCOVA|||The average MΔ of anti-Aβ40 antibody signal between the two treatment groups was compared using an ANCOVA model, using the MΔ anti-Aβ40 antibody signal as the dependent variable, baseline anti-Aβ40 antibody signal (OD in ELISA) as covariate and treatment group and amyloid positivity as fixed effects.||3.34|2.96|<0.0001
72447082|NCT03461276|144411504|SUPERIORITY||||||<|0.0001|||||||t-test, 1 sided|t-test (sensitivity hypothesis). A 1-sided t-test with a significance level of 0.025 was employed.||"1-sided t-test to compare the ABvac40 and placebo groups.~The primary analysis (t-test) was repeated, using the mITT Analysis Set to test the hypothesis:~* Null hypothesis: average MΔ anti-Aβ40 (ABvac40) - average MΔ anti-Aβ40 (placebo) ≤ 1.778~* Alternative hypothesis: average MΔ anti-Aβ40 (ABvac40) - average MΔ anti-Aβ40 (placebo) \> 1.778 The alternative hypothesis was confirmed."||||<0.0001
72619377|NCT00098293|144769621|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was to be concluded if the lower bound of the 1-sided 97.5% CI was \> -10%.|Difference in Percentage|-4.1|||||ONE_SIDED|97.5|-10.5|||||||Less than 400 copies/mL: Treatment difference in percentage stratified by randomization strata (screening viral load and geographic region) was presented along with the lower bound of the 1-sided 97.5% CI based on the normal approximation to the binomial distribution. Positive value would favor maraviroc. Step down procedure used to control for multiple comparisons.|||-10.5|
72447083|NCT03461276|144411504|SUPERIORITY||||||<|0.05|||||||Mixed Models Analysis|||"The change in anti-Aβ40 antibody signal from baseline to each post-baseline efficacy visit was analyzed using a Mixed-Model Repeated Measures (MMRM), using the mITT Analysis Set.~Dependent variable: change from baseline in anti-Aβ40 antibody signal. Fixed effects: treatment, protocol-specified visits, treatment-by-visit interaction, and amyloid positivity. Covariates: baseline anti-Aβ40 antibody signal and baseline age; Repeated measure: measures within-patient at each visit."||||<0.05
72447084|NCT03461276|144411511|OTHER||||||<|0.001|||||||Mixed Models Analysis|||MMRM - Week 50A||||<0.001
72447085|NCT03461276|144411511|OTHER||||||=|0.047|||||||Mixed Models Analysis|||MMRM - Week 104A||||= 0.047
72447086|NCT03461276|144411512|OTHER||||||=|0.9936|||||||Mixed Models Analysis|||MMRM - Week 2A||||= 0.9936
72447087|NCT03461276|144411512|OTHER||||||=|0.0391||||||MMRM - Week 6A|Mixed Models Analysis|||MMRM - Week 6A||||= 0.0391
72447088|NCT03461276|144411512|OTHER||||||<|0.0001|||||||Mixed Models Analysis|||MMRM - Week 10A||||< 0.0001
72447089|NCT03461276|144411512|OTHER||||||<|0.0001|||||||Mixed Models Analysis|||MMRM - Week 14A||||< 0.0001
72447090|NCT03461276|144411512|OTHER||||||<|0.0001|||||||Mixed Models Analysis|||MMRM - Week 18A||||< 0.0001
72447091|NCT03461276|144411512|OTHER||||||<|0.0001|||||||Mixed Models Analysis|||MMRM - Week 24A||||< 0.0001
72447092|NCT03461276|144411512|OTHER||||||=|0.0299|||||||Mixed Models Analysis|||MMRM - Week 40A||||= 0.0299
72447093|NCT03461276|144411512|OTHER||||||<|0.0001|||||||Mixed Models Analysis|||MMRM - Week 44A||||< 0.0001
72447094|NCT03461276|144411512|OTHER||||||<|0.0001|||||||Mixed Models Analysis|||MMRM - Week 50A||||< 0.0001
72447095|NCT03461276|144411512|OTHER||||||=|0.1267|||||||Mixed Models Analysis|||MMRM - Week 77A||||= 0.1267
72447096|NCT03461276|144411512|OTHER|MMRM - Week 104A|||||=|0.2477|||||||Mixed Models Analysis|||||||= 0.2477
72447097|NCT03461276|144411513|OTHER||||||=|0.2151|||||||Mixed Models Analysis|||MMRM - Week 2A||||= 0.2151
72447098|NCT03461276|144411513|OTHER||||||=|0.0169|||||||Mixed Models Analysis|||MMRM - Week 6A||||= 0.0169
72447099|NCT03461276|144411513|OTHER||||||=|0.0008|||||||Mixed Models Analysis|||MMRM - Week 10A||||= 0.0008
72447100|NCT03461276|144411513|OTHER||||||=|0.0002|||||||Mixed Models Analysis|||MMRM - Week 14A||||= 0.0002
72447101|NCT03461276|144411513|OTHER||||||<|0.0001|||||||Mixed Models Analysis|||MMRM - Week 18A||||< 0.0001
72447102|NCT03461276|144411513|OTHER||||||=|0.0023|||||||Mixed Models Analysis|||MMRM - Week 24A||||= 0.0023
72447103|NCT03461276|144411513|OTHER||||||=|0.0021|||||||Mixed Models Analysis|||MMRM - Week 40A||||= 0.0021
72447104|NCT03461276|144411513|OTHER||||||=|0.0007|||||||Mixed Models Analysis|||MMRM - Week 44A||||= 0.0007
72447105|NCT03461276|144411513|OTHER||||||=|0.0012|||||||Mixed Models Analysis|||MMRM - Week 50A||||= 0.0012
72447106|NCT03461276|144411513|OTHER||||||=|0.0018|||||||Mixed Models Analysis|||MMRM - Week 77A||||= 0.0018
72447107|NCT03461276|144411513|OTHER||||||=|0.738|||||||Mixed Models Analysis|||MMRM - Week 104A||||= 0.738
72447108|NCT03461276|144411514|OTHER||||||=|0.7623|||||||Mixed Models Analysis|||MMRM - Week 2A||||= 0.7623
72447109|NCT03461276|144411514|OTHER||||||=|0.1506|||||||Mixed Models Analysis|||MMRM - Week 6A||||= 0.1506
72447110|NCT03461276|144411514|OTHER||||||=|0.1071|||||||Mixed Models Analysis|||MMRM - Week 10A||||= 0.1071
72498107|NCT04025632|144526701|SUPERIORITY||LS mean difference|5.53||||0.265|TWO_SIDED|95.0|-4.49|15.55||Based on a linear model with treatment and strata (anti-HMGCR+/anti-SRP+) as fixed factors with Baseline FACIT-Fatigue Scale as a covariate.|Linear Mixed Effect Model||The difference presented is zilucoplan 0.3 mg/kg minus placebo.|||15.55|-4.49|0.265
72498108|NCT02274688|144526717|SUPERIORITY||||||=|0.01|||||||Wald Chi-Square=11.29, df=3, P=0.01|||"Mixed Model Regression; Data from all 171 patients at all time points used in this intent-to-treat analytic approach.~We hypothesize intervention patients will demonstrate diminished outcome severity over time when compared to nurse notification patients, as evidenced by a significant group by time interaction effect."||||=0.01
72498109|NCT02274688|144526718|SUPERIORITY||||||=|0.23|||||||Wald Chi-Square=3.01, df=3, p=0.23|||"Mixed Model Regression; Data from all 171 patients at all time points used in this intent-to-treat analytic approach.~We hypothesize intervention patients will demonstrate diminished outcome severity over time when compared to nurse notification patients, as evidenced by a significant group by time interaction effect."||||=0.23
72619378|NCT00098293|144769621|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was to be concluded if the lower bound of the 1-sided 97.5% CI was \> -10%.|Difference in Percentage|-4.4|||||ONE_SIDED|97.5|-11.2|||||||Less than 50 copies/mL: Treatment difference in percentage stratified by randomization strata (screening viral load and geographic region) was presented along with the lower bound of the 1-sided 97.5% CI based on the normal approximation to the binomial distribution. Positive value would favor maraviroc. Step down procedure used to control for multiple comparisons.|||-11.2|
72498110|NCT02274688|144526719|SUPERIORITY||||||=|0.23|||||||Wald Chi-Square=4.25, df=3, p=0.23|||"Mixed Model Regression; Data from all 171 patients at all time points used in this intent-to-treat analytic approach.~We hypothesize intervention patients will demonstrate diminished outcome severity over time when compared to nurse notification patients, as evidenced by a significant group by time interaction effect."||||=0.23
72498111|NCT02274688|144526720|SUPERIORITY||||||=|0.55|||||||Wald Chi-Square=2.12, df=3, p=0.55|||"Mixed Model Regression; Data from all 171 patients at all time points used in this intent-to-treat analytic approach.~We hypothesize intervention patients will demonstrate diminished outcome severity over time when compared to nurse notification patients, as evidenced by a significant group by time interaction effect."||||=0.55
72498112|NCT02274688|144526721|SUPERIORITY||||||=|0.32|||||||Wald Chi-Square=3.52, df=3; p=0.32|||"Mixed Model Regression; Data from all 171 patients at all time points used in this intent-to-treat analytic approach.~We hypothesize intervention patients will demonstrate diminished outcome severity over time when compared to nurse notification patients, as evidenced by a significant group by time interaction effect."||||=0.32
72498113|NCT02274688|144526722|SUPERIORITY||||||=|0.26|||||||Wald Chi-Square=4.02, df=3, p=0.26|||"Mixed Model Regression; Data from all 171 patients at all time points used in this intent-to-treat analytic approach.~We hypothesize intervention patients will demonstrate diminished outcome severity over time when compared to nurse notification patients, as evidenced by a significant group by time interaction effect."||||=0.26
72498114|NCT02274688|144526723|SUPERIORITY||||||=|0.22|||||||Wald Chi-Square=4.44, df=3, p=0.22|||"Mixed Model Regression; Data from all 171 patients at all time points used in this intent-to-treat analytic approach.~We hypothesize intervention patients will demonstrate diminished outcome severity over time when compared to nurse notification patients, as evidenced by a significant group by time interaction effect."||||=0.22
72498115|NCT02274688|144526724|SUPERIORITY||||||=|0.08||||||F(3,507)=2.24, P=0.08|Regression Poisson|||"Mixed Model Regression; Data from all 171 patients at all time points used in this intent-to-treat analytic approach.~We hypothesize intervention patients will demonstrate diminished outcome severity over time when compared to nurse notification patients, as evidenced by a significant group by time interaction effect."||||=0.08
72498116|NCT02274688|144526725|SUPERIORITY|||||||0.36|||||||Wald Chi-Square=3.24, df=3, p=0.36|||"Mixed Model Regression; Data from all 171 patients at all time points used in this intent-to-treat analytic approach.~We hypothesize intervention patients will demonstrate diminished outcome severity over time when compared to nurse notification patients, as evidenced by a significant group by time interaction effect."||||0.36
72498117|NCT00391599|144526741|SUPERIORITY_OR_OTHER|||||||0.15|TWO_SIDED||||||Chi-squared|||||||0.15
72498118|NCT00391599|144526743|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Chi-squared|||||||<0.05
72498119|NCT02300129|144526759|SUPERIORITY_OR_OTHER|||||||0.742|TWO_SIDED|||||P value associated to treatment effect in the model. Study design with a power of 80% and a type I error at 5% (two-sided).|ANOVA|Analysis of variance including sequence, subject (sequence), period and treatment as factors in the model||||||0.7420
72498120|NCT00522392|144526788|SUPERIORITY_OR_OTHER|||||||0.092|TWO_SIDED||||||Log Rank|||Stratified log rank test was used to compare progression-free survival between the two arms.||||0.092
72498121|NCT00522392|144526789|SUPERIORITY_OR_OTHER|||||||0.029|TWO_SIDED||||||Fisher Exact|||Fisher's exact test was used to compare the response rates between the two arms.||||0.029
72498122|NCT00522392|144526790|SUPERIORITY_OR_OTHER|||||||0.48|TWO_SIDED||||||Log Rank|||Stratified log-rank test was used to compare overall survival between the two arms.||||0.48
72498123|NCT00432237|144526819|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Regression, Logistic|P-value constructed using a logistic model adjusting for baseline severity (moderate, severe), region (US, ex-US), treatment and age (continuous).||||||<0.001
72447111|NCT03461276|144411514|OTHER||||||=|0.0212|||||||Mixed Models Analysis|||MMRM - Week 14A||||= 0.0212
72447112|NCT03461276|144411514|OTHER||||||=|0.0014|||||||Mixed Models Analysis|||MMRM - Week 18A||||= 0.0014
72447113|NCT03461276|144411514|OTHER||||||<|0.0001|||||||Mixed Models Analysis|||MMRM - Week 24A||||< 0.0001
72447114|NCT03461276|144411514|OTHER||||||<|0.0001|||||||Mixed Models Analysis|||MMRM - Week 40A||||< 0.0001
72447115|NCT03461276|144411514|OTHER||||||<|0.0001|||||||Mixed Models Analysis|||MMRM - Week 44A||||< 0.0001
72447116|NCT03461276|144411514|OTHER||||||<|0.0001|||||||Mixed Models Analysis|||MMRM - Week 50A||||< 0.0001
72447117|NCT03461276|144411514|OTHER||||||<|0.0001|||||||Mixed Models Analysis|||MMRM - Week 77A||||< 0.0001
72447118|NCT03461276|144411514|OTHER||||||=|0.0251|||||||Mixed Models Analysis|||MMRM - Week 104A||||= 0.0251
72447119|NCT03461276|144411515|OTHER||||||=|0.6515|||||||Mixed Models Analysis|||MMRM - Week 2A||||= 0.6515
72447120|NCT03461276|144411515|OTHER||||||=|0.7447|||||||Mixed Models Analysis|||MMRM - Week 6A||||= 0.7447
72447121|NCT03461276|144411515|OTHER||||||=|0.4518|||||||Mixed Models Analysis|||MMRM - Week 10A||||= 0.4518
72447122|NCT03461276|144411515|OTHER||||||=|0.5416|||||||Mixed Models Analysis|||MMRM - Week 14A||||= 0.5416
72447123|NCT03461276|144411515|OTHER||||||=|0.3504|||||||Mixed Models Analysis|||MMRM - Week 18A||||= 0.3504
72447124|NCT03461276|144411515|OTHER||||||=|0.2109|||||||Mixed Models Analysis|||MMRM - Week 24A||||= 0.2109
72447125|NCT03461276|144411515|OTHER||||||=|0.0049|||||||Mixed Models Analysis|||MMRM - Week 40A||||= 0.0049
72447126|NCT03461276|144411515|OTHER||||||=|0.0498|||||||Mixed Models Analysis|||MMRM - Week 44A||||= 0.0498
72498124|NCT00432237|144526819|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Regression, Logistic|P-value constructed using a logistic model adjusting for baseline severity (moderate, severe), region (US, ex-US), treatment and age (continuous).||||||<0.001
72447127|NCT03461276|144411515|OTHER||||||=|0.2181|||||||Mixed Models Analysis|||MMRM - Week 50A||||= 0.2181
72447128|NCT03461276|144411515|OTHER||||||=|0.2087|||||||Mixed Models Analysis|||MMRM - Week 77A||||= 0.2087
72447129|NCT03461276|144411515|OTHER||||||=|0.8599|||||||Mixed Models Analysis|||MMRM - Week 104A||||= 0.8599
72447130|NCT03461276|144411516|OTHER||||||=|0.9469|||||||Mixed Models Analysis|||MMRM - Week 2A||||= 0.9469
72447131|NCT03461276|144411516|OTHER||||||=|0.9063|||||||Mixed Models Analysis|||MMRM - Week 6A||||= 0.9063
72498125|NCT00432237|144526820|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Regression, Logistic|P-value constructed using a logistic model adjusting for baseline severity (moderate, severe), region (US, ex-US), treatment and age (continuous).||||||<0.001
72447132|NCT03461276|144411516|OTHER||||||=|0.3418|||||||Mixed Models Analysis|||MMRM - Week 10A||||= 0.3418
72447133|NCT03461276|144411516|OTHER||||||=|0.0236|||||||Mixed Models Analysis|||MMRM - Week 14A||||= 0.0236
72447134|NCT03461276|144411516|OTHER||||||=|0.0012|||||||Mixed Models Analysis|||MMRM - Week 18A||||= 0.0012
72447135|NCT03461276|144411516|OTHER||||||=|0.0004|||||||Mixed Models Analysis|||MMRM - Week 24A||||= 0.0004
72447136|NCT03461276|144411516|OTHER||||||=|0.0008|||||||Mixed Models Analysis|||MMRM - Week 40A||||= 0.0008
72447137|NCT03461276|144411516|OTHER||||||<|0.0001|||||||Mixed Models Analysis|||MMRM - Week 44A||||< 0.0001
72447138|NCT03461276|144411516|OTHER||||||<|0.0001|||||||Mixed Models Analysis|||MMRM - Week 50A||||< 0.0001
72447139|NCT03461276|144411516|OTHER||||||=|0.1255|||||||Mixed Models Analysis|||MMRM - Week 77A||||= 0.1255
72447140|NCT03461276|144411516|OTHER||||||=|0.4232|||||||Mixed Models Analysis|||MMRM - Week 104A||||= 0.4232
72447141|NCT03461276|144411517|OTHER||||||=|0.9211|||||||Mixed Models Analysis|||MMRM - Week 2A||||= 0.9211
72447142|NCT03461276|144411517|OTHER||||||=|0.2817|||||||Mixed Models Analysis|||MMRM - Week 6A||||= 0.2817
72447143|NCT03461276|144411517|OTHER||||||=|0.2984|||||||Mixed Models Analysis|||MMRM - Week 10A||||= 0.2984
72447144|NCT03461276|144411517|OTHER||||||=|0.8402|||||||Mixed Models Analysis|||MMRM - Week 14A||||= 0.8402
72447145|NCT03461276|144411517|OTHER||||||=|0.4428|||||||Mixed Models Analysis|||MMRM - Week 18A||||= 0.4428
72447146|NCT03461276|144411517|OTHER||||||=|0.4156|||||||Mixed Models Analysis|||MMRM - Week 24A||||= 0.4156
72447147|NCT03461276|144411517|OTHER||||||=|0.8706|||||||Mixed Models Analysis|||MMRM - Week 40A||||= 0.8706
72447148|NCT03461276|144411517|OTHER||||||=|0.8691|||||||Mixed Models Analysis|||MMRM - Week 44A||||= 0.8691
72447149|NCT03461276|144411517|OTHER||||||=|0.2188|||||||Mixed Models Analysis|||MMRM - Week 50A||||= 0.2188
72447150|NCT03461276|144411517|OTHER||||||=|0.1448|||||||Mixed Models Analysis|||MMRM - Week 77A||||= 0.1448
72447151|NCT03461276|144411517|OTHER||||||=|0.5004|||||||Mixed Models Analysis|||MMRM - Week 104A||||= 0.5004
72447152|NCT03461276|144411518|OTHER||||||=|0.1058|||||||Mixed Models Analysis|||MMRM - Week 50A||||= 0.1058
72447153|NCT03461276|144411518|OTHER||||||=|0.0922|||||||Mixed Models Analysis|||MMRM - Week 104A||||= 0.0922
72447154|NCT03461276|144411519|OTHER||||||=|0.9313|||||||Mixed Models Analysis|||MMRM - Week 24A||||= 0.9313
72447155|NCT03461276|144411519|OTHER||||||=|0.2243|||||||Mixed Models Analysis|||MMRM - Week 50A||||= 0.2243
72447156|NCT03461276|144411519|OTHER||||||=|0.0952|||||||Mixed Models Analysis|||MMRM - Week 104A||||= 0.0952
72447157|NCT03461276|144411520|OTHER||||||=|0.3599|||||||Mixed Models Analysis|||MMRM - Week 24A - left||||= 0.3599
72447158|NCT03461276|144411520|OTHER||||||=|0.8913|||||||Mixed Models Analysis|||MMRM - Week 50A - left||||= 0.8913
72447159|NCT03461276|144411520|OTHER||||||=|0.4736|||||||Mixed Models Analysis|||MMRM - Week 104A - left||||= 0.4736
72447160|NCT03461276|144411520|OTHER||||||=|0.9095|||||||Mixed Models Analysis|||MMRM - Week 24A - right||||= 0.9095
72447161|NCT03461276|144411520|OTHER||||||=|0.8744|||||||Mixed Models Analysis|||MMRM - Week 50A - right||||= 0.8744
72447162|NCT03461276|144411520|OTHER||||||=|0.9307|||||||Mixed Models Analysis|||MMRM - Week 104A - right||||= 0.9307
72447163|NCT03461276|144411521|OTHER||||||=|0.3982|||||||Mixed Models Analysis|||MMRM - Week 24A||||= 0.3982
72447164|NCT03461276|144411521|OTHER||||||=|0.7035|||||||Mixed Models Analysis|||MMRM - Week 50A||||= 0.7035
72447165|NCT03461276|144411521|OTHER||||||=|0.6334|||||||Mixed Models Analysis|||MMRM - Week 104A||||= 0.6334
72447166|NCT03461276|144411522|OTHER||||||=|0.2193|||||||Mixed Models Analysis|||MMRM - Week 50A||||= 0.2193
72447167|NCT03461276|144411522|OTHER||||||=|0.5543|||||||Mixed Models Analysis|||MMRM - Week 104A||||= 0.5543
72447168|NCT03461276|144411523|OTHER||||||=|0.7324|||||||Mixed Models Analysis|||MMRM - Week 50A||||= 0.7324
72447169|NCT03461276|144411523|OTHER||||||=|0.1719|||||||Mixed Models Analysis|||MMRM - Week 104A||||= 0.1719
72447170|NCT03461276|144411524|OTHER||||||=|0.7977|||||||Mixed Models Analysis|||MMRM - Week 50A||||= 0.7977
72447171|NCT03461276|144411524|OTHER||||||=|0.8828|||||||Mixed Models Analysis|||MMRM - Week 104A||||= 0.8828
72447172|NCT03461276|144411525|OTHER||||||=|0.7954|||||||Mixed Models Analysis|||MMRM - Week 50A||||= 0.7954
72447173|NCT03461276|144411525|OTHER||||||=|0.5895|||||||Mixed Models Analysis|||MMRM - Week 104A||||= 0.5895
72447174|NCT03461276|144411526|OTHER||||||=|0.743|||||||Mixed Models Analysis|||MMRM - Week 50A||||= 0.743
72447175|NCT03461276|144411526|OTHER||||||=|0.832|||||||Mixed Models Analysis|||MMRM - Week 104A||||= 0.832
72447176|NCT03461276|144411527|OTHER||||||=|0.2283|||||||Mixed Models Analysis|||MMRM - Week 50A||||= 0.2283
72447177|NCT03461276|144411527|OTHER||||||=|0.886|||||||Mixed Models Analysis|||MMRM - Week 104A||||= 0.886
72561382|NCT03538262|144653364|OTHER|||||||0.564|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 15||||0.564
72498126|NCT00432237|144526820|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Regression, Logistic|P-value constructed using a logistic model adjusting for baseline severity (moderate, severe), region (US, ex-US), treatment and age (continuous).||||||<0.001
72498127|NCT00432237|144526821|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Regression, Logistic|P-value constructed using a logistic model adjusting for baseline severity (moderate, severe), region (US, ex-US), treatment and age (continuous).||||||<0.001
72498128|NCT00432237|144526821|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Regression, Logistic|P-value constructed using a logistic model adjusting for baseline severity (moderate, severe), region (US, ex-US), treatment and age (continuous).||||||<0.001
72447178|NCT03461276|144411528|OTHER||||||=|0.909|||||||Mixed Models Analysis|||MMRM - Week 50A||||= 0.909
72447179|NCT03461276|144411528|OTHER||||||=|0.8498|||||||Mixed Models Analysis|||MMRM - Week 104A||||= 0.8498
72447180|NCT03461276|144411529|OTHER||||||=|0.8711|||||||Mixed Models Analysis|||MMRM - Week 24A||||= 0.8711
72447181|NCT03461276|144411529|OTHER||||||=|0.1098|||||||Mixed Models Analysis|||MMRM - Week 50A||||= 0.1098
72447182|NCT03461276|144411529|OTHER||||||=|0.6179|||||||Mixed Models Analysis|||MMRM - Week 77A||||= 0.6179
72561383|NCT03538262|144653364|OTHER|||||||0.034|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 21||||0.034
72447183|NCT03461276|144411529|OTHER||||||=|0.3715|||||||Mixed Models Analysis|||MMRM - Week 104A||||= 0.3715
72447184|NCT03461276|144411530|OTHER||||||=|0.8949|||||||Mixed Models Analysis|||MMRM - Week 24A||||= 0.8949
72447185|NCT03461276|144411530|OTHER||||||=|0.8712|||||||Mixed Models Analysis|||MMRM - Week 50A||||= 0.8712
72447186|NCT03461276|144411530|OTHER||||||=|0.8748|||||||Mixed Models Analysis|||MMRM - Week 77A||||= 0.8748
72447187|NCT03461276|144411530|OTHER||||||=|0.6402|||||||Mixed Models Analysis|||MMRM - Week 104A||||= 0.6402
72447188|NCT03461276|144411531|OTHER||||||=|0.552|||||||Mixed Models Analysis|||MMRM - Week 24A||||= 0.552
72498129|NCT00432237|144526822|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Regression, Logistic|P-value constructed using a logistic model adjusting for baseline severity (moderate, severe), region (US, ex-US), treatment and age (continuous).||||||<0.001
72498130|NCT00432237|144526822|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Regression, Logistic|P-value constructed using a logistic model adjusting for baseline severity (moderate, severe), region (US, ex-US), treatment and age (continuous).||||||<0.001
72498131|NCT00432237|144526823|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Regression, Logistic|P-value constructed using a logistic model adjusting for baseline severity (moderate, severe), region (US, ex-US), treatment and age (continuous).||||||<0.001
72498132|NCT00432237|144526823|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Regression, Logistic|P-value constructed using a logistic model adjusting for baseline severity (moderate, severe), region (US, ex-US), treatment and age (continuous).||||||<0.001
72498133|NCT00432237|144526824|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Regression, Logistic|P-value constructed using a logistic model adjusting for baseline severity (moderate, severe), region (US, ex-US), treatment and age (continuous).||||||<0.001
72498134|NCT00432237|144526824|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Regression, Logistic|P-value constructed using a logistic model adjusting for baseline severity (moderate, severe), region (US, ex-US), treatment and age (continuous).||||||<0.001
72447189|NCT03461276|144411531|OTHER||||||=|0.9371|||||||Mixed Models Analysis|||MMRM - Week 50A||||= 0.9371
72447190|NCT03461276|144411531|OTHER||||||=|0.2354|||||||Mixed Models Analysis|||MMRM - Week 77A||||= 0.2354
72447191|NCT03461276|144411531|OTHER||||||=|0.4608|||||||Mixed Models Analysis|||MMRM - Week 104A||||= 0.4608
72447192|NCT03461276|144411532|OTHER||||||=|0.3246|||||||Mixed Models Analysis|||MMRM - Week 24A||||= 0.3246
72447193|NCT03461276|144411532|OTHER||||||=|0.8047|||||||Mixed Models Analysis|||MMRM - Week 50A||||= 0.8047
72447194|NCT03461276|144411532|OTHER||||||=|0.916|||||||Mixed Models Analysis|||MMRM - Week 77A||||= 0.916
72447195|NCT03461276|144411532|OTHER||||||=|0.9582|||||||Mixed Models Analysis|||MMRM - Week 104A||||= 0.9582
72447196|NCT03461276|144411533|OTHER||||||=|0.777|||||||Mixed Models Analysis|||MMRM - Week 24A - Trail A||||= 0.777
72447197|NCT03461276|144411533|OTHER||||||=|0.1727|||||||Mixed Models Analysis|||MMRM - Week 50A - Trail A||||= 0.1727
72447198|NCT03461276|144411533|OTHER||||||=|0.0218|||||||Mixed Models Analysis|||MMRM - Week 77A - Trail A||||= 0.0218
72447199|NCT03461276|144411533|OTHER||||||=|0.2789|||||||Mixed Models Analysis|||MMRM - Week 104A - Trail A||||= 0.2789
72447200|NCT03461276|144411533|OTHER||||||=|0.2261|||||||Mixed Models Analysis|||MMRM - Week 24A - Trail B||||= 0.2261
72447201|NCT03461276|144411533|OTHER||||||=|0.9743|||||||Mixed Models Analysis|||MMRM - Week 50A - Trail B||||= 0.9743
72447202|NCT03461276|144411533|OTHER||||||=|0.2556|||||||Mixed Models Analysis|||MMRM - Week 77A - Trail B||||= 0.2556
72447203|NCT03461276|144411533|OTHER||||||=|0.1008|||||||Mixed Models Analysis|||MMRM - Week 104A - Trail B||||= 0.1008
72447204|NCT03461276|144411534|OTHER||||||=|0.6189|||||||Mixed Models Analysis|||MMRM - Week 24A||||= 0.6189
72447205|NCT03461276|144411534|OTHER||||||=|0.6937|||||||Mixed Models Analysis|||MMRM - Week 50A||||= 0.6937
72447206|NCT03461276|144411534|OTHER||||||=|0.6981|||||||Mixed Models Analysis|||MMRM - Week 104A||||= 0.6981
72447207|NCT03461276|144411536|OTHER||||||=|0.2863|||||||Mixed Models Analysis|||MMRM - Week 50A||||= 0.2863
72561384|NCT03538262|144653365|OTHER|||||||0.409|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 12||||0.409
72561385|NCT03538262|144653365|OTHER|||||||0.149|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 0.149||||0.149
72561386|NCT02033317|144653368|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.14|TWO_SIDED||||||paired t-test|||||||= 0.14
72561387|NCT02033317|144653369|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.02|TWO_SIDED||||||paired t-test|||||||= 0.02
72561388|NCT00608634|144653384|SUPERIORITY_OR_OTHER|||||||0.1|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||0.10
72447208|NCT03461276|144411536|OTHER||||||=|0.3703|||||||Mixed Models Analysis|||MMRM - Week 104A||||= 0.3703
72447209|NCT03461276|144411537|OTHER||||||=|0.9663|||||||Mixed Models Analysis|||MMRM - Week 50A||||= 0.9663
72447210|NCT03461276|144411537|OTHER||||||=|0.3843|||||||Mixed Models Analysis|||MMRM - Week 104A||||= 0.3843
72447211|NCT03461276|144411538|SUPERIORITY||||||<|0.0001||||||A 1-sided t-test with a significance level of 0.025 was employed.|t-test, 1 sided|||"The trial was considered successfully confirmatory regarding efficacy (immunogenicity) of ABvac40 if the average MΔ of anti-Aβ40 antibody signal (OD in ELISA) in the ABvac40 group was significantly greater than the average MΔ of anti-Aβ40 antibody signal in the Placebo group. i.e.~* Null hypothesis: average MΔ anti-Aβ40 (ABvac40) ≤ average MΔ anti-Aβ40 (placebo).~* Alternative hypothesis: average MΔ anti-Aβ40 (ABvac40) \> average MΔ anti-Aβ40 (placebo)"||||< 0.0001
72447212|NCT03461276|144411538|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||< 0.0001
72447213|NCT03461276|144411538|SUPERIORITY||Mean Difference (Final Values)|3.21|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001|TWO_SIDED|95.0|3.02|3.4|||ANCOVA|||||3.4|3.02|< 0.0001
72447214|NCT03865498|144411566|SUPERIORITY||Odds Ratio (OR)|7.029|||<|0.0001|TWO_SIDED|95.0|4.919|10.323||McNemar's Chi-squared test (paired) with continuity correction to the test slightly more conservative|McNemar|||Hypothesis: There will be significant pre/post-intervention differences in isolated macro-level network structures for African American dementia caregiver networks.||10.323|4.919|< 0.0001
72447215|NCT03865498|144411566|SUPERIORITY||Odds Ratio (OR)|17.385|||<|0.0001|TWO_SIDED|95.0|9.963|33.157||McNemar's Chi-squared test (paired) with continuity correction to the test slightly more conservative|McNemar|||Hypothesis: There will be significant pre/post-intervention differences in isolated macro-level network structures for Hispanic dementia caregiver networks.||33.157|9.963|<0.0001
72447216|NCT03865498|144411566|SUPERIORITY||Odds Ratio (OR)|1.021||||0.924|TWO_SIDED|95.0|0.787|1.325||Pearson's Chi-squared test with Yates' continuity correction|Chi-squared, Corrected|||There will be no significant differences in isolated macro-level network structure from Tweets between Hispanic and African American dementia caregiver networks.||1.325|0.787|0.924
72447217|NCT03865498|144411567|SUPERIORITY|Pre-post mean difference|Mean Difference (Final Values)|0.628|||<|0.0001|TWO_SIDED|95.0|0.513|0.742|||a paired t-test|||Hypothesis: There will be significant pre/post-intervention differences in emotional valence score detected from Tweets for African American dementia caregiver networks.||0.742|0.513|<0.0001
72447218|NCT03865498|144411567|SUPERIORITY|Pre-post mean difference|Mean Difference (Final Values)|1.41|||<|0.0001|TWO_SIDED|95.0|1.189|1.631|||a paired t-test|||Hypothesis: There will be significant pre/post-intervention differences in emotional valence score detected from Tweets for Hispanic dementia caregiver networks.||1.631|1.189|<0.0001
72447219|NCT03865498|144411567|SUPERIORITY||Mean Difference (Final Values)|0.039||||0.6|TWO_SIDED|95.0|-0.186|0.107|||t-test, 2 sided|||There will be no significant differences in emotional valence score detected from Tweets between Hispanic and African American dementia caregiver networks.||0.107|-0.186|0.600
72447220|NCT05329220|144411632|NON_INFERIORITY|The success criterion for the null hypothesis that ABNCoV2 is inferior to Comirnaty will be rejected if the ratio of the GMTs for ABNCoV2 versus Comirnaty is within the non-inferiority margin of 0.67; that is, the lower bound of the 2-sided 97.5% CI of the GMT ratio is \>=0.67.|Geometric Mean Ratio|0.89||||0.635|TWO_SIDED|97.5|0.5|1.57||P-value corresponds to Cohort 1 ABNCoV2 comparison to Cohort 1 Comirnaty|Mixed Models Analysis|A generalized linear model with age and baseline results included as covariates was used to compare between the vaccination groups.||Formal hypothesis testing was performed due to having at least 400 evaluable subjects with primary endpoint data available at baseline and at 2 weeks after trial vaccination. The null hypothesis is that ABNCoV2 is inferior to Comirnaty and will be rejected if the ratio of the GMTs for ABNCoV2 versus Comirnaty is within the non-inferiority margin of 0.67; that is, the lower bound of the 2-sided 97.5% CI of the GMT ratio is \>=0.67.||1.57|0.50|0.6350
72447221|NCT05329220|144411632|NON_INFERIORITY|The success criterion for the null hypothesis that ABNCoV2 is inferior to Comirnaty will be rejected if the ratio of the GMTs for ABNCoV2 versus Comirnaty is within the non-inferiority margin of 0.67; that is, the lower bound of the 2-sided 97.5% CI of the GMT ratio is \>=0.67.|Geometric Mean Ratio|0.8||||0.0002|TWO_SIDED|97.5|0.7|0.92||P-value corresponds to Cohort 2 ABNCoV2 comparison to Cohort 2 Comirnaty|Mixed Models Analysis|A generalized linear model with age and baseline results included as covariates was used to compare between the vaccination groups.||Formal hypothesis testing was performed due to having at least 400 evaluable subjects with primary endpoint data available at baseline and at 2 weeks after trial vaccination. The null hypothesis is that ABNCoV2 is inferior to Comirnaty and will be rejected if the ratio of the GMTs for ABNCoV2 versus Comirnaty is within the non-inferiority margin of 0.67; that is, the lower bound of the 2-sided 97.5% CI of the GMT ratio is \>=0.67.||0.92|0.70|0.0002
72447222|NCT05329220|144411633|NON_INFERIORITY|The success criterion for the null hypothesis that ABNCoV2 is inferior to Comirnaty will be rejected if the ratio of the GMTs for ABNCoV2 versus Comirnaty is within the non-inferiority margin of 0.67; that is, the lower bound of the 2-sided 97.5% CI of the GMT ratio is \>=0.67.|Geometric Mean Ratio|0.76||||0.0008|TWO_SIDED|97.5|0.64|0.91||P-value corresponds to Cohort 2 ABNCoV2 comparison to Cohort 2 Comirnaty for Omicron variant BA.4/BA.5|Mixed Models Analysis|A generalized linear model with age and baseline results included as covariates was used to compare between the vaccination groups.||Formal hypothesis testing was performed due to meeting the primary endpoint success criterion in Cohort 2. The null hypothesis is that ABNCoV2 is inferior to Comirnaty and will be rejected if the ratio of the GMTs for ABNCoV2 versus Comirnaty is within the non-inferiority margin of 0.67; that is, the lower bound of the 2-sided 97.5% CI of the GMT ratio is \>=0.67.||0.91|0.64|0.0008
72447223|NCT05329220|144411633|NON_INFERIORITY|The success criterion for the null hypothesis that ABNCoV2 is inferior to Comirnaty will be rejected if the ratio of the GMTs for ABNCoV2 versus Comirnaty is within the non-inferiority margin of 0.67; that is, the lower bound of the 2-sided 97.5% CI of the GMT ratio is \>=0.67.|Geometric Mean Ratio|0.69|||<|0.0001|TWO_SIDED|97.5|0.59|0.81||P-value corresponds to Cohort 2 ABNCoV2 comparison to Cohort 2 Comirnaty for Omicron Variant XBB.1.5.|Mixed Models Analysis|A generalized linear model with age and baseline results included as covariates was used to compare between the vaccination groups.||Formal hypothesis testing was performed due to meeting the primary endpoint success criterion in Cohort 2. The null hypothesis is that ABNCoV2 is inferior to Comirnaty and will be rejected if the ratio of the GMTs for ABNCoV2 versus Comirnaty is within the non-inferiority margin of 0.67; that is, the lower bound of the 2-sided 97.5% CI of the GMT ratio is \>=0.67.||0.81|0.59|<0.0001
72447224|NCT04802967|144411724|SUPERIORITY||Mean Difference (Final Values)|0.02||||0.998|TWO_SIDED|95.0|-17.81|17.86|||Mixed Model Repeated Measures.|The p value was determined using MMRM model, based on treatment, timepoint, baseline value as covariable and subject as a random effect.||Outcome Measure at 15 minutes post injection||17.86|-17.81|0.998
72447225|NCT04802967|144411724|SUPERIORITY||Mean Difference (Final Values)|-6.9||||0.445|TWO_SIDED|95.0|-24.73|10.93||The p value was determined using MMRM model, based on treatment, timepoint, baseline value as covariable and subject as a random effect.|Mixed Model Repeated Measures.|||Outcome Measure at 15 minutes post injection||10.93|-24.73|0.445
72447226|NCT04802967|144411724|SUPERIORITY||Mean Difference (Final Values)|2.51||||0.781|TWO_SIDED|95.0|-15.33|20.36||The p value was determined using MMRM model, based on treatment, timepoint, baseline value as covariable and subject as a random effect.|Mixed Model Repeated Measures.|||Outcome Measure at 15 minutes post injection||20.36|-15.33|0.781
72447227|NCT04802967|144411724|SUPERIORITY||Mean Difference (Final Values)|-3.09||||0.732|TWO_SIDED|95.0|-20.93|14.75||The p value was determined using MMRM model, based on treatment, timepoint, baseline value as covariable and subject as a random effect.|Mixed Model Repeated Measures.|||Outcome Measure at 15 minutes post injection||14.75|-20.93|0.732
72447228|NCT04802967|144411724|SUPERIORITY||Mean Difference (Final Values)|11.3||||0.212|TWO_SIDED|95.0|-6.53|29.14||The p value was determined using MMRM model, based on treatment, timepoint, baseline value as covariable and subject as a random effect.|Mixed Model Repeated Measures.|||Outcome Measure at 15 minutes post injection||29.14|-6.53|0.212
72447229|NCT04802967|144411724|SUPERIORITY||Mean Difference (Final Values)|-6.44||||0.476|TWO_SIDED|95.0|-24.27|11.39|||Mixed Model Repeated Measures.|The p value was determined using MMRM model, based on treatment, timepoint, baseline value as covariable and subject as a random effect.||Outcome Measure at 15 minutes post injection||11.39|-24.27|0.476
72447230|NCT04802967|144411724|SUPERIORITY||Mean Difference (Final Values)|0.43||||0.962|TWO_SIDED|95.0|-17.4|18.26|||Mixed Model Repeated Measures.|The p value was determined using MMRM model, based on treatment, timepoint, baseline value as covariable and subject as a random effect.||Outcome Measure at 15 minutes post injection||18.26|-17.40|0.962
72447231|NCT04802967|144411724|SUPERIORITY||Mean Difference (Final Values)|12.1||||0.211|TWO_SIDED|95.0|-6.96|31.16|||Mixed Model Repeated Measures.|The p value was determined using MMRM model, based on treatment, timepoint, baseline value as covariable and subject as a random effect.||Outcome Measure at 30 minutes post injection||31.16|-6.96|0.211
72447232|NCT04802967|144411724|SUPERIORITY||Mean Difference (Final Values)|2.67||||0.782|TWO_SIDED|95.0|-16.4|21.73|||Mixed Model Repeated Measures.|The p value was determined using MMRM model, based on treatment, timepoint, baseline value as covariable and subject as a random effect.||Outcome Measure at 30 minutes post injection||21.73|-16.40|0.782
72447233|NCT04802967|144411724|SUPERIORITY||Mean Difference (Final Values)|14.72||||0.129|TWO_SIDED|95.0|-4.34|33.78|||Mixed Model Repeated Measures.|The p value was determined using MMRM model, based on treatment, timepoint, baseline value as covariable and subject as a random effect.||Outcome Measure at 30 minutes post injection||33.78|-4.34|0.129
72447234|NCT04802967|144411724|SUPERIORITY||Mean Difference (Final Values)|13.27||||0.171|TWO_SIDED|95.0|-5.8|32.35|||Mixed Model Repeated Measures.|The p value was determined using MMRM model, based on treatment, timepoint, baseline value as covariable and subject as a random effect.||Outcome Measure at 30 minutes post injection||32.35|-5.80|0.171
72447235|NCT04802967|144411724|SUPERIORITY||Mean Difference (Final Values)|15.56||||0.108|TWO_SIDED|95.0|-3.49|34.62|||Mixed Model Repeated Measures.|The p value was determined using MMRM model, based on treatment, timepoint, baseline value as covariable and subject as a random effect.||Outcome Measure at 30 minutes post injection||34.62|-3.49|0.108
72447236|NCT04802967|144411724|SUPERIORITY||Mean Difference (Final Values)|4.24||||0.661|TWO_SIDED|95.0|-14.83|23.3|||Mixed Model Repeated Measures.|The p value was determined using MMRM model, based on treatment, timepoint, baseline value as covariable and subject as a random effect.||Outcome Measure at 30 minutes post injection||23.30|-14.83|0.661
72447237|NCT04802967|144411724|SUPERIORITY||Mean Difference (Final Values)|14.21||||0.142|TWO_SIDED|95.0|-4.85|33.27|||Mixed Model Repeated Measures.|The p value was determined using MMRM model, based on treatment, timepoint, baseline value as covariable and subject as a random effect.||Outcome Measure at 30 minutes post injection||33.27|-4.85|0.142
72447238|NCT04802967|144411724|SUPERIORITY||Mean Difference (Final Values)|11.98||||0.216|TWO_SIDED|95.0|-7.08|31.04|||Mixed Model Repeated Measures.|The p value was determined using MMRM model, based on treatment, timepoint, baseline value as covariable and subject as a random effect.||Outcome Measure at 60 minutes post injection||31.04|-7.08|0.216
72447239|NCT04802967|144411724|SUPERIORITY||Mean Difference (Final Values)|7.38||||0.445|TWO_SIDED|95.0|-11.71|26.48|||Mixed Model Repeated Measures.|The p value was determined using MMRM model, based on treatment, timepoint, baseline value as covariable and subject as a random effect.||Outcome Measure at 60 minutes post injection||26.48|-11.71|0.445
72447240|NCT04802967|144411724|SUPERIORITY||Mean Difference (Final Values)|16.13||||0.096|TWO_SIDED|95.0|-2.92|35.19|||Mixed Model Repeated Measures.|The p value was determined using MMRM model, based on treatment, timepoint, baseline value as covariable and subject as a random effect.||Outcome Measure at 60 minutes post injection||35.19|-2.92|0.096
72447241|NCT04802967|144411724|SUPERIORITY||Mean Difference (Final Values)|11.89||||0.22|TWO_SIDED|95.0|-7.19|30.96|||Mixed Model Repeated Measures.|The p value was determined using MMRM model, based on treatment, timepoint, baseline value as covariable and subject as a random effect.||Outcome Measure at 60 minutes post injection||30.96|-7.19|0.220
72447242|NCT04802967|144411724|SUPERIORITY||Mean Difference (Final Values)|12.71||||0.189|TWO_SIDED|95.0|-6.35|31.78|||Mixed Model Repeated Measures.|The p value was determined using MMRM model, based on treatment, timepoint, baseline value as covariable and subject as a random effect.||Outcome Measure at 60 minutes post injection||31.78|-6.35|0.189
72447243|NCT04802967|144411724|SUPERIORITY||Mean Difference (Final Values)|-2.67||||0.782|TWO_SIDED|95.0|-21.75|16.41|||Mixed Model Repeated Measures.|The p value was determined using MMRM model, based on treatment, timepoint, baseline value as covariable and subject as a random effect.||Outcome Measure at 60 minutes post injection||16.41|-21.75|0.782
72447244|NCT04802967|144411724|SUPERIORITY||Mean Difference (Final Values)|6.1||||0.528|TWO_SIDED|95.0|-12.98|25.18|||Mixed Model Repeated Measures.|The p value was determined using MMRM model, based on treatment, timepoint, baseline value as covariable and subject as a random effect.||Outcome Measure at 60 minutes post injection||25.18|-12.98|0.528
72561389|NCT00608634|144653384|SUPERIORITY_OR_OTHER|||||||0.41|||||||Wilcoxon (Mann-Whitney)|||||||0.41
72447245|NCT04802967|144411724|SUPERIORITY||Mean Difference (Final Values)|2.34||||0.795|TWO_SIDED|95.0|-15.45|20.12|||Mixed Model Repeated Measures.|The p value was determined using MMRM model, based on treatment, timepoint, baseline value as covariable and subject as a random effect.||Outcome Measure at 90 minutes post injection||20.12|-15.45|0.795
72447246|NCT04802967|144411724|SUPERIORITY||Mean Difference (Final Values)|-6.13||||0.497|TWO_SIDED|95.0|-23.96|11.69|||mean difference|The p value was determined using MMRM model, based on treatment, timepoint, baseline value as covariable and subject as a random effect.||Outcome Measure at 90 minutes post injection||11.69|-23.96|0.497
72447247|NCT04802967|144411724|SUPERIORITY||Mean Difference (Final Values)|7.44||||0.409|TWO_SIDED|95.0|-10.34|25.21|||Mixed Model Repeated Measures.|The p value was determined using MMRM model, based on treatment, timepoint, baseline value as covariable and subject as a random effect.||Outcome Measure at 90 minutes post injection||25.21|-10.34|0.409
72498135|NCT00432237|144526825|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Regression, Logistic|P-value constructed using a logistic model adjusting for baseline severity (moderate, severe), region (US, ex-US), treatment and age (continuous).||||||<0.001
72498136|NCT00432237|144526825|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Regression, Logistic|P-value constructed using a logistic model adjusting for baseline severity (moderate, severe), region (US, ex-US), treatment and age (continuous).||||||<0.001
72498137|NCT00432237|144526826|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Regression, Logistic|P-value constructed using a logistic model adjusting for baseline severity (moderate, severe), region (US, ex-US), treatment and age (continuous).||||||<0.001
72498138|NCT00432237|144526826|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Regression, Logistic|P-value constructed using a logistic model adjusting for baseline severity (moderate, severe), region (US, ex-US), treatment and age (continuous).||||||<0.001
72498139|NCT00603239|144526827|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||No adjustments were made (alpha = 0.05).|ANCOVA|No adjustments for multiplicity were made.||Null hypothesis = Change from baseline in HbA1c is equal between the two treatment groups. Greater than 99% power to detect a difference between treatment groups of 0.88% in change in HbA1c from baseline using a 2-sided t-test at a significance level of 0.05.||||<0.001
72498140|NCT00603239|144526828|SUPERIORITY_OR_OTHER|||||||0.113||95.0||||No adjustments (alpha = 0.05).|CMH test|No adjustment for multiplicity.||Null hypothesis = Proportion of subjects with HbA1c \<= 7% is equal between the two treatment groups.||||0.113
72498141|NCT00603239|144526829|SUPERIORITY_OR_OTHER|||||||0.004||95.0||||No adjustments (alpha = 0.05).|CMH test|No adjustment for multiplicity.||Null hypothesis = Proportion of subjects achieving HbA1c \<= 6.5% is equal between the two treatment groups.||||0.004
72447248|NCT04802967|144411724|SUPERIORITY||Mean Difference (Final Values)|7.89||||0.382|TWO_SIDED|95.0|-9.92|25.7|||Mixed Model Repeated Measures.|The p value was determined using MMRM model, based on treatment, timepoint, baseline value as covariable and subject as a random effect.||Outcome Measure at 90 minutes post injection||25.70|-9.92|0.382
72447249|NCT04802967|144411724|SUPERIORITY||Mean Difference (Final Values)|7.74||||0.39|TWO_SIDED|95.0|-10.05|25.54|||Mixed Model Repeated Measures.|The p value was determined using MMRM model, based on treatment, timepoint, baseline value as covariable and subject as a random effect.||Outcome Measure at 90 minutes post injection||25.54|-10.05|0.390
72498142|NCT00603239|144526830|SUPERIORITY_OR_OTHER|||||||0.009||95.0||||No adjustments (alpha = 0.05).|ANCOVA|No adjustment for multiplicity.||Null hypothesis = Change from baseline in FSG is equal between the two treatment groups.||||0.009
72498143|NCT00603239|144526831|SUPERIORITY_OR_OTHER|||||||0.176||95.0||||No adjustments (alpha = 0.05).|ANCOVA|No adjustment for multiplicity.||Null hypothesis = Change from baseline to endpoint in body weight is equal between the two treatment groups.||||0.176
72498144|NCT00603239|144526833|SUPERIORITY_OR_OTHER|||||||0.009||95.0||||No adjustments (alpha = 0.05).|ANCOVA|No adjustment for multiplicity.||Null hypothesis = Change form baseline in HOMA-B is equal between the two treatment groups.||||0.009
72498145|NCT00603239|144526834|SUPERIORITY_OR_OTHER|||||||0.794||95.0||||No adjustments (alpha = 0.05).|ANCOVA|No adjustment for multiplicity.||Null hypothesis = Change from baseline in HOMA-S is equal between the two treatment groups.||||0.794
72498146|NCT00603239|144526835|SUPERIORITY_OR_OTHER|||||||1||95.0||||No adjustments (alpha = 0.05).|Fisher Exact|No adjustment for multiplicity.||Null hypothesis = Incidence of minor hypoglycemia episodes is equal between the two treatment groups.||||1.00
72498147|NCT00603239|144526836|SUPERIORITY_OR_OTHER|||||||0.342||95.0||||No adjustments (alpha = 0.05).|ANCOVA|No adjustment for multiplicity.||Null hypothesis = Change from baseline in IWQOL-Lite Total Score is equal between the two treatment groups. This statistical analysis is for the Total Score only.||||0.342
72498148|NCT00603239|144526837|SUPERIORITY_OR_OTHER|||||||0.186||95.0||||No adjustments (alpha = 0.05)|ANCOVA|No adjustment for multiplicity.||Null hypothesis = Change from baseline in EQ-5D score is equal between the two treatment groups. This statistical analysis is for the EQ-5D Health State Score only.||||0.186
72498149|NCT01354132|144526838|SUPERIORITY|||||||0.5|||||||t-test, 2 sided|||||||0.50
72447250|NCT04802967|144411724|SUPERIORITY||Mean Difference (Final Values)|-3.72||||0.68|TWO_SIDED|95.0|-21.54|14.1|||Mixed Model Repeated Measures.|The p value was determined using MMRM model, based on treatment, timepoint, baseline value as covariable and subject as a random effect.||Outcome Measure at 90 minutes post injection||14.10|-21.54|0.680
72498150|NCT01354132|144526839|SUPERIORITY|||||||0.39|||||||t-test, 2 sided|||||||0.39
72498151|NCT01354132|144526840|SUPERIORITY|||||||0.52|||||||t-test, 2 sided|||||||0.52
72498152|NCT01354132|144526841|SUPERIORITY|||||||0.71|||||||t-test, 2 sided|||||||0.71
72498153|NCT01354132|144526842|SUPERIORITY|||||||0.022|||||||t-test, 2 sided|||Speed of Processing||||0.022
72498154|NCT01354132|144526843|SUPERIORITY|||||||0.27|||||||t-test, 2 sided|||||||0.270
72498155|NCT01354132|144526844|SUPERIORITY|||||||0.153|||||||t-test, 2 sided|||||||0.153
72498156|NCT01354132|144526845|SUPERIORITY|||||||0.876|||||||t-test, 2 sided|||||||0.876
72498157|NCT01354132|144526846|SUPERIORITY|||||||0.464|||||||t-test, 2 sided|||||||0.464
72498158|NCT01354132|144526847|SUPERIORITY|||||||0.741|||||||t-test, 2 sided|||||||0.741
72498159|NCT01354132|144526848|SUPERIORITY|||||||0.05|||||||t-test, 2 sided|||||||0.05
72498160|NCT01354132|144526849|SUPERIORITY|||||||0.33|||||||t-test, 2 sided|||||||0.33
72498161|NCT01354132|144526850|SUPERIORITY|||||||0.9|||||||t-test, 2 sided|||||||0.90
72498162|NCT01354132|144526851|SUPERIORITY|||||||0.6732|||||||t-test, 1 sided|||||||0.6732
72498163|NCT01354132|144526852|SUPERIORITY|||||||0.8786|||||||t-test, 2 sided|||||||0.8786
72447251|NCT04802967|144411724|SUPERIORITY||Mean Difference (Final Values)|0.83||||0.927|TWO_SIDED|95.0|-16.99|18.65|||Mixed Model Repeated Measures.|The p value was determined using MMRM model, based on treatment, timepoint, baseline value as covariable and subject as a random effect.||Outcome Measure at 90 minutes post injection||18.65|-16.99|0.927
72447252|NCT04802967|144411724|SUPERIORITY||Mean Difference (Final Values)|6.02||||0.508|TWO_SIDED|95.0|-11.95|23.98||The p value was determined using MMRM model, based on treatment, timepoint, baseline value as covariable and subject as a random effect.|Mixed Model Repeated Measures.|||Outcome Measure at 120 minutes post injection||23.98|-11.95|0.508
72447253|NCT04802967|144411724|SUPERIORITY||Mean Difference (Final Values)|-3.65||||0.688|TWO_SIDED|95.0|-21.66|14.35|||Mixed Model Repeated Measures.|The p value was determined using MMRM model, based on treatment, timepoint, baseline value as covariable and subject as a random effect.||Outcome Measure at 120 minutes post injection||14.35|-21.66|0.688
72447254|NCT04802967|144411724|SUPERIORITY||Mean Difference (Final Values)|16.08||||0.079|TWO_SIDED|95.0|-1.88|34.03|||Mixed Model Repeated Measures.|The p value was determined using MMRM model, based on treatment, timepoint, baseline value as covariable and subject as a random effect.||Outcome Measure at 120 minutes post injection||34.03|-1.88|0.079
72390382|NCT04115839|144288574|SUPERIORITY||Difference in response rates|28.3||||0.019|TWO_SIDED|95.0|2.4|54.2||P-value was calculated from the logistic regression with treatment groups and stratification factors (geographic region, concurrent use of csDMARD(s) and/or apremilast at randomization, prior use of bioDMARD(s)) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 12||54.2|2.4|0.019
72390383|NCT04115839|144288574|SUPERIORITY||Difference in response rates|2.9||||0.85|TWO_SIDED|95.0|-22.5|28.4||P-value was calculated from the logistic regression with treatment groups and stratification factors (geographic region, concurrent use of csDMARD(s) and/or apremilast at randomization, prior use of bioDMARD(s)) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 12||28.4|-22.5|0.85
72390384|NCT04115839|144288574|SUPERIORITY||Difference in response rates|25.9||||0.036|TWO_SIDED|95.0|-0.4|52.3||P-value was calculated from the logistic regression with treatment groups and stratification factors (geographic region, concurrent use of csDMARD(s) and/or apremilast at randomization, prior use of bioDMARD(s)) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||52.3|-0.4|0.036
72390385|NCT04115839|144288574|SUPERIORITY||Difference in response rates|6.1||||0.6|TWO_SIDED|95.0|-19.7|31.8||P-value was calculated from the logistic regression with treatment groups and stratification factors (geographic region, concurrent use of csDMARD(s) and/or apremilast at randomization, prior use of bioDMARD(s)) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||31.8|-19.7|0.60
72390386|NCT04115839|144288576|SUPERIORITY||Difference in response rates|6.0||||0.31|TWO_SIDED|95.0|-7.8|19.8||P-value was calculated from the logistic regression with treatment groups and stratification factors (geographic region, concurrent use of csDMARD(s) and/or apremilast at randomization, prior use of bioDMARD(s)) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 2||19.8|-7.8|0.31
72390387|NCT04115839|144288576|SUPERIORITY||Difference in response rates|-2.8||||0.48|TWO_SIDED|95.0|-11.1|5.5||P-value was calculated from the logistic regression with treatment groups and stratification factors (geographic region, concurrent use of csDMARD(s) and/or apremilast at randomization, prior use of bioDMARD(s)) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 2||5.5|-11.1|0.48
72390388|NCT04115839|144288576|SUPERIORITY||Difference in response rates|2.5||||0.7|TWO_SIDED|95.0|-14.1|19.2||P-value was calculated from the logistic regression with treatment groups and stratification factors (geographic region, concurrent use of csDMARD(s) and/or apremilast at randomization, prior use of bioDMARD(s)) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||19.2|-14.1|0.70
72390389|NCT04115839|144288576|SUPERIORITY||Difference in response rates|-8.6||||0.17|TWO_SIDED|95.0|-20.7|3.6||P-value was calculated from the logistic regression with treatment groups and stratification factors (geographic region, concurrent use of csDMARD(s) and/or apremilast at randomization, prior use of bioDMARD(s)) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||3.6|-20.7|0.17
72390390|NCT04115839|144288576|SUPERIORITY||Difference in response rates|6.5||||0.34|TWO_SIDED|95.0|-12.5|25.6||P-value was calculated from the logistic regression with treatment groups and stratification factors (geographic region, concurrent use of csDMARD(s) and/or apremilast at randomization, prior use of bioDMARD(s)) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 8||25.6|-12.5|0.34
72390391|NCT04115839|144288576|SUPERIORITY||Difference in response rates|-0.3||||0.98|TWO_SIDED|95.0|-16.9|16.4||P-value was calculated from the logistic regression with treatment groups and stratification factors (geographic region, concurrent use of csDMARD(s) and/or apremilast at randomization, prior use of bioDMARD(s)) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 8||16.4|-16.9|0.98
72390392|NCT04115839|144288576|SUPERIORITY||Difference in response rates|18.7||||0.071|TWO_SIDED|95.0|-5.1|42.5||P-value was calculated from the logistic regression with treatment groups and stratification factors (geographic region, concurrent use of csDMARD(s) and/or apremilast at randomization, prior use of bioDMARD(s)) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 12||42.5|-5.1|0.071
72447255|NCT04802967|144411724|SUPERIORITY||Mean Difference (Final Values)|9.0||||0.323|TWO_SIDED|95.0|-8.96|26.96|||Mixed Model Repeated Measures.|The p value was determined using MMRM model, based on treatment, timepoint, baseline value as covariable and subject as a random effect.||Outcome Measure at 120 minutes post injection||26.96|-8.96|0.323
72498164|NCT01354132|144526853|SUPERIORITY|||||||0.5622|||||||t-test, 2 sided|||||||0.5622
72498165|NCT01354132|144526854|SUPERIORITY|||||||0.9574|||||||t-test, 2 sided|||||||0.9574
72498166|NCT01354132|144526855|SUPERIORITY|||||||0.0043|||||||t-test, 2 sided|||||||0.0043
72498167|NCT01354132|144526856|SUPERIORITY|||||||0.3804|||||||t-test, 2 sided|||||||0.3804
72498168|NCT01354132|144526857|SUPERIORITY|||||||0.9403|||||||t-test, 2 sided|||||||0.9403
72498169|NCT01354132|144526858|SUPERIORITY|||||||0.9215|||||||t-test, 2 sided|||||||0.9215
72498170|NCT02357420|144526859|SUPERIORITY|||||||0.36|||||||Measures mixed effects model (MMRM)|MMRM analysis used treatment, week, treatment-by-week interaction as fixed factors and baseline values as the covariates.||||||0.36
72498171|NCT02357420|144526859|SUPERIORITY|||||||0.25|||||||MMRM|MMRM analysis used treatment, week, treatment-by-week interaction as fixed factors and baseline values as the covariates.||||||0.25
72498172|NCT02357420|144526859|SUPERIORITY|||||||0.59|||||||MMRM|MMRM analysis used treatment, week, treatment-by-week interaction as fixed factors and baseline values as the covariates.||||||0.59
72498173|NCT00928070|144526864|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.65|STANDARD_ERROR_OF_MEAN|0.21||0.0018|TWO_SIDED|95.0|-1.05|-0.24||Statistical testing, two-sided, was done at 5% alpha level.|ANCOVA|||Analysis of covariance (ANCOVA) model with terms for treatment, center, centered baseline, and centered baseline by treatment interaction was used to calculate p-value.||-0.24|-1.05|0.0018
72498174|NCT00928070|144526865|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.82|STANDARD_ERROR_OF_MEAN|0.23||0.0003|TWO_SIDED|95.0|-1.27|-0.38||Statistical testing, two-sided, was done at 5% significance level.|ANCOVA|||ANCOVA model with terms for treatment, center, centered baseline, and centered baseline by treatment interaction was used to calculate p-value.||-0.38|-1.27|0.0003
72498175|NCT00928070|144526866|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Statistical testing, two-sided, was done at 5% alpha level.|Ranked ANCOVA|Testing for percent change from baseline was only carried out for given endpoint if corresponding numeric change result was statistically significant.||Change at Week 4: Ranked ANCOVA model with terms for treatment and center with ranked baseline value as a covariate was used to calculate p-value.||||<0.0001
72498176|NCT00928070|144526866|SUPERIORITY_OR_OTHER|||||||0.0001|TWO_SIDED|||||Statistical testing, two-sided, was done at 5% alpha level.|Ranked ANCOVA|Testing for percent change from baseline was only carried out for given endpoint if corresponding numeric change result was statistically significant.||Change at Week 12: Ranked ANCOVA model with terms for treatment and center with ranked baseline value as a covariate was used to calculate p-value.||||0.0001
72498177|NCT00928070|144526868|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.87|STANDARD_ERROR_OF_MEAN|0.24||0.0003|TWO_SIDED|95.0|-1.35|-0.4||Statistical testing, two-sided, was done at 5% alpha level.|ANCOVA|||Change at Week 4: ANCOVA model with terms for treatment and center with centered baseline as a covariate was used to calculate p-value.||-0.40|-1.35|0.0003
72561390|NCT00608634|144653385|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Chi-squared|||||||>0.05
72498178|NCT00928070|144526868|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.84|STANDARD_ERROR_OF_MEAN|0.23||0.0003|TWO_SIDED|95.0|-1.29|-0.39||Statistical testing, two-sided, was done at 5% alpha level.|ANCOVA|||Change at Week 12: ANCOVA model with terms for treatment and center with centered baseline as a covariate was used to calculate p-value.||-0.39|-1.29|0.0003
72498179|NCT00928070|144526869|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Statistical testing, two-sided, was done at 5% alpha level.|Ranked ANCOVA|Testing for percent change from baseline was only carried out for given endpoint if corresponding numeric change result was statistically significant.||Change at Week 4: Ranked ANCOVA model with terms for treatment and center with ranked baseline value as a covariate was used to calculate p-value.||||<0.0001
72498180|NCT00928070|144526869|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Statistical testing, two-sided, was done at 5% alpha level.|Ranked ANCOVA|Testing for percent change from baseline was only carried out for given endpoint if corresponding numeric change result was statistically significant.||Change at Week 12: Ranked ANCOVA model with terms for treatment and center with ranked baseline value as a covariate was used to calculate p-value.||||<0.0001
72498181|NCT00928070|144526871|SUPERIORITY_OR_OTHER||Least squares mean difference|-1.1|STANDARD_ERROR_OF_MEAN|0.34||0.0014|TWO_SIDED|95.0|-1.77|-0.43||Statistical testing, two-sided, was done at 5% alpha level.|ANCOVA|||Change at Week 4: ANCOVA model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.||-0.43|-1.77|0.0014
72498182|NCT00928070|144526871|SUPERIORITY_OR_OTHER||Least squares mean difference|-1.4|STANDARD_ERROR_OF_MEAN|0.35|<|0.0001|TWO_SIDED|95.0|-2.1|-0.7||Statistical testing, two-sided, was done at 5% alpha level.|ANCOVA|||Change at Week 12: ANCOVA model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.||-0.70|-2.10|<0.0001
72498183|NCT00928070|144526872|SUPERIORITY_OR_OTHER|||||||0.0002|TWO_SIDED|||||Statistical testing, two-sided, was done at 5% alpha level.|Ranked ANCOVA|Testing for percent change from baseline was only carried out for given endpoint if corresponding numeric change result was statistically significant.||Change at Week 4: Ranked ANCOVA model with terms for treatment and center with ranked baseline value as a covariate was used to calculate p-value.||||0.0002
72498184|NCT00928070|144526872|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Statistical testing, two-sided, was done at 5% alpha level.|Ranked ANCOVA|Testing for percent change from baseline was only carried out for given endpoint if corresponding numeric change result was statistically significant.||Change at Week 12: Ranked ANCOVA model with terms for treatment and center with ranked baseline value as a covariate was used to calculate p-value.||||<0.0001
72561391|NCT00749658|144653424|OTHER|Two tailed testing||||||0.07|||||||SAS|||||||0.07
72561392|NCT01525628|144653425|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 17 vs. Day 9 (%)|251.37|STANDARD_DEVIATION|31.0||1|TWO_SIDED|90.0|205.54|307.43|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of BI 201335 at Day 17 vs. Day 9 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 17 vs. Day 9||307.43|205.54|1.0000
72498185|NCT00928070|144526874|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.15|STANDARD_ERROR_OF_MEAN|0.13||0.2511|TWO_SIDED|95.0|-0.39|0.1||Statistical testing, two-sided, was done at 5% alpha level.|ANCOVA|||Change at Week 4: ANCOVA model with terms for treatment and center with centered Baseline value as a covariate was used to calculate p-value.||0.10|-0.39|0.2511
72498186|NCT00928070|144526874|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.29|STANDARD_ERROR_OF_MEAN|0.12||0.0189|TWO_SIDED|95.0|-0.53|-0.05||Statistical testing, two-sided, was done at 5% alpha level.|ANCOVA|||Change at Week 12: ANCOVA model with terms for treatment and center with centered Baseline value as a covariate was used to calculate p-value.||-0.05|-0.53|0.0189
72498187|NCT00928070|144526875|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED|||||Statistical testing, two-sided, was done at 5% significance level.|Ranked ANCOVA|Testing for percent change from baseline was only carried out for given endpoint if corresponding numeric change result was statistically significant.||Change at Week 12: Ranked ANCOVA model with terms for treatment and center with ranked baseline value as a covariate was used to calculate p-value.||||0.0010
72447256|NCT04802967|144411724|SUPERIORITY||Mean Difference (Final Values)|11.23||||0.183|TWO_SIDED|95.0|-5.39|27.85|||Mixed Model Repeated Measures.|The p value was determined using MMRM model, based on treatment, timepoint, baseline value as covariable and subject as a random effect.||Outcome Measure at 120 minutes post injection||27.85|-5.39|0.183
72447257|NCT04802967|144411724|SUPERIORITY||Mean Difference (Final Values)|-2.61||||0.756|TWO_SIDED|95.0|-19.24|14.02|||Mixed Model Repeated Measures.|The p value was determined using MMRM model, based on treatment, timepoint, baseline value as covariable and subject as a random effect.||Outcome Measure at 120 minutes post injection||14.02|-19.24|0.756
72447258|NCT04802967|144411724|SUPERIORITY||Mean Difference (Final Values)|3.96||||0.638|TWO_SIDED|95.0|-12.68|20.59|||Mixed Model Repeated Measures.|The p value was determined using MMRM model, based on treatment, timepoint, baseline value as covariable and subject as a random effect.||Outcome Measure at 120 minutes post injection||20.59|-12.68|0.638
72447259|NCT04114877|144411734|SUPERIORITY||||||>|0.05|||||||Mixed Models Analysis|Linear mixed models||||||>0.05
72447260|NCT04114877|144411735|SUPERIORITY||||||>|0.05|||||||Mixed Models Analysis|Linear mixed models||||||>0.05
72447261|NCT04114877|144411736|SUPERIORITY||||||>|0.05|||||||Mixed Models Analysis|Linear mixed models||||||>0.05
72498188|NCT00928070|144526877|SUPERIORITY_OR_OTHER||Least squares mean difference|-4.67|STANDARD_ERROR_OF_MEAN|1.21||0.0001|TWO_SIDED|95.0|-7.04|-2.3||Statistical testing, two-sided, was done at 5% alpha level.|ANCOVA|||Change at Week 4: ANCOVA model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.||-2.30|-7.04|0.0001
72498189|NCT00928070|144526877|SUPERIORITY_OR_OTHER||Least squares mean difference|-4.97|STANDARD_ERROR_OF_MEAN|1.17|<|0.0001|TWO_SIDED|95.0|-7.27|-2.66||Statistical testing, two-sided, was done at 5% alpha level.|ANCOVA|||Change at Week 12: ANCOVA model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.||-2.66|-7.27|<0.0001
72498190|NCT00928070|144526878|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.34|STANDARD_ERROR_OF_MEAN|0.11||0.0035|TWO_SIDED|95.0|-0.56|-0.11||Statistical testing, two-sided, was done at 5% alpha level.|t-test, 2 sided|||Change at Week 4: =\<3.5 undergarments- Protective undergarment usage was analyzed to compare treatments on separate subsets, based on baseline protective undergarment use (=\<3.5/day and \>3.5/day), using a 2 sample t-test. This method was applied because there was a statistically significant qualitative baseline by treatment interaction.||-0.11|-0.56|0.0035
72498191|NCT00928070|144526878|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.45|STANDARD_ERROR_OF_MEAN|1.21||0.7089|TWO_SIDED|95.0|-2.01|2.92||Statistical testing, two-sided, was done at 5% alpha level.|t-test, 2 sided|||Change at Week 4: \>3.5 undergarments- Protective undergarment usage was analyzed to compare treatments on separate subsets, based on baseline protective undergarment use (=\<3.5/day and \>3.5/day), using a 2 sample t-test. This method was applied because there was a statistically significant qualitative baseline by treatment interaction.||2.92|-2.01|0.7089
72447262|NCT04114877|144411737|SUPERIORITY||||||>|0.05|||||||Mixed Models Analysis|Linear mixed models||||||>0.05
72498192|NCT00928070|144526878|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.41|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001|TWO_SIDED|95.0|-0.61|-0.21||Statistical testing, two-sided, was done at 5% alpha level.|t-test, 2 sided|||Change at Week 12: =\<2.5 undergarments- Protective undergarment usage was analyzed to compare treatments on separate subsets, based on baseline protective undergarment use (=\<2.5/day and \>2.5/day), using a 2 sample t-test. This method was applied because there was a statistically significant qualitative baseline by treatment interaction.||-0.21|-0.61|<0.0001
72447263|NCT04114877|144411738|SUPERIORITY|||||||0.455|||||||Fisher Exact|||||||0.455
72447264|NCT06429319|144411739|SUPERIORITY||F value|5.919||||0.004|TWO_SIDED|||||The threshold for statistical significance was p \<0.05.|ANCOVA|"To compare the efficacy of one and two NOLTREX™ courses was used ANCOVA adjusted for the baseline value with fixed factor of treatment group."||No sample size calculation was performed. Maximum expected number of participants for OLE was 72 patients randomized to the NOLTREX™ group in the parent study (IA/PAAG-SI/OA/2019). A total of 65 patients entered the OLE. The study did not have a formal hypothesis. The between-group comparison of changes from baseline (OLE visit 0) in the WOMAC-T at visit 5 was conducted using analysis of covariance (ANCOVA) and, as a post hoc test, the Tukey test.||||0.004
72447265|NCT06429319|144411739|SUPERIORITY||LS-means difference|-37.64|STANDARD_ERROR_OF_MEAN|56.34||0.783|TWO_SIDED|95.0|-172.98|97.7||Difference between Least-square means was tested at a level of p \<0.05 via Tukey's multiple comparison test|Tukey's HSD|||Post-hoc pairwise comparisons were performed using Tukey test.||97.70|-172.98|0.783
72447266|NCT06429319|144411739|SUPERIORITY||LS-means difference|81.94|STANDARD_ERROR_OF_MEAN|60.45||0.37|TWO_SIDED|95.0|-63.28|227.16|||Tukey's HSD|||Post-hoc pairwise comparisons were performed using Tukey test.||227.16|-63.28|0.370
72447267|NCT06429319|144411739|SUPERIORITY||LS-means difference|119.58|STANDARD_ERROR_OF_MEAN|34.76||0.003|TWO_SIDED|95.0|36.09|203.07||Difference between Least-square means was tested at a level of p \<0.05 via Tukey's multiple comparison test.|Tukey's HSD|||Post-hoc pairwise comparisons were performed using Tukey test.||203.07|36.09|0.003
72447268|NCT06429319|144411739|SUPERIORITY||F value|2.78||||0.07|TWO_SIDED|||||The threshold for statistical significance was p \<0.05.|ANCOVA|"To compare the efficacy of one and two NOLTREX™ courses was used ANCOVA adjusted for the baseline value with fixed factor of treatment group."||The between-group comparison of changes from baseline (visit 1 study 1) in the WOMAC-T at visit 5 was conducted using analysis of covariance (ANCOVA) and, as a post hoc test, the Tukey test.||||0.070
72447269|NCT06429319|144411743|SUPERIORITY|||||||0.03||||||The threshold for statistical significance was p \<0.05.|Kruskal-Wallis|||"BASELINE (study 1 visit 1)~To determine a statistically significant difference between 3 groups the one-way ANOVA (for normally distributed data; aov) or the Kruskal-Wallis test (for non-normally distributed data; kw) was used. The Shapiro-Wilk test was employed to assess the normality of the data distribution."||||0.030
72447270|NCT06429319|144411743|SUPERIORITY|||||||0.002||||||The threshold for statistical significance was p \<0.05.|Kruskal-Wallis|||"BASELINE (OLE visit 0)~To determine a statistically significant difference between 3 groups the one-way ANOVA (for normally distributed data; aov) or the Kruskal-Wallis test (for non-normally distributed data; kw) was used. The Shapiro-Wilk test was employed to assess the normality of the data distribution."||||0.002
72447271|NCT06429319|144411743|SUPERIORITY|||||||0.007||||||The threshold for statistical significance was p \<0.05.|ANOVA|||"visit 3~To determine a statistically significant difference between 3 groups the one-way ANOVA (for normally distributed data; aov) or the Kruskal-Wallis test (for non-normally distributed data; kw) was used. The Shapiro-Wilk test was employed to assess the normality of the data distribution."||||0.007
72447272|NCT06429319|144411743|SUPERIORITY||||||<|0.001||||||The threshold for statistical significance was p \<0.05.|Kruskal-Wallis|||"visit 5~To determine a statistically significant difference between 3 groups the one-way ANOVA (for normally distributed data; aov) or the Kruskal-Wallis test (for non-normally distributed data; kw) was used. The Shapiro-Wilk test was employed to assess the normality of the data distribution."||||<0.001
72447273|NCT06429319|144411744|SUPERIORITY||||||<|0.001||||||The threshold for statistical significance was p \<0.05.|Fisher Exact|||"Fisher's exact test was used to determine whether there is a significant difference between 3 groups.~visit 3"||||<0.001
72447274|NCT06429319|144411744|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||"visit 5~Fisher's exact test was used to determine whether there is a significant difference between 3 groups."||||<0.001
72447275|NCT06429319|144411745|SUPERIORITY|||||||0.018||||||The threshold for statistical significance was p \<0.05.|Fisher Exact|||"visit 3~Fisher's exact test was used to determine whether there was a significant difference between 3 groups."||||0.018
72447276|NCT06429319|144411745|SUPERIORITY||||||<|0.001||||||The threshold for statistical significance was p \<0.05.|Fisher Exact|||"visit 5~Fisher's exact test was used to determine whether there was a significant difference between 3 groups."||||<0.001
72447277|NCT06429319|144411748|SUPERIORITY|||||||0.01||||||The threshold for statistical significance was p \<0.05.|Kruskal-Wallis|||To determine a statistically significant difference between 3 groups the one-way ANOVA (for normally distributed data; aov) or the Kruskal-Wallis test (for non-normally distributed data; kw) was used. The Shapiro-Wilk test was employed to assess the normality of the data distribution.||||0.010
72498193|NCT00928070|144526878|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.15|STANDARD_ERROR_OF_MEAN|0.47||0.7437|TWO_SIDED|95.0|-0.78|1.09||Statistical testing, two-sided, was done at 5% alpha level.|t-test, 2 sided|||Change at Week 12: \>2.5 undergarments- Protective undergarment usage was analyzed to compare treatments on separate subsets, based on baseline protective undergarment use (=\<2.5/day and \>2.5/day), using a 2 sample t-test. This method was applied because there was a statistically significant qualitative baseline by treatment interaction.||1.09|-0.78|0.7437
72498194|NCT00928070|144526879|SUPERIORITY_OR_OTHER|||||||0.0009|TWO_SIDED|||||Statistical testing, two-sided, was done at 5% alpha level.|Cochran-Mantel-Haenszel|||Change at Week 4- deterioration, no change, minor improvement and major improvement: Cochran-Mantel-Haenszel (CMH) test with modified ridit scoring controlling for center was used to calculate p-value.||||0.0009
72498195|NCT00928070|144526879|SUPERIORITY_OR_OTHER|||||||0.0021|TWO_SIDED|||||Statistical testing, two-sided, was done at 5% alpha level.|Cochran-Mantel-Haenszel|||Change at Week 12- deterioration, no change, minor improvement and major improvement: CMH test with modified ridit scoring controlling for center was used to calculate p-value.||||0.0021
72561393|NCT01525628|144653425|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 66 vs. Day 9 (%)|131.3|STANDARD_DEVIATION|32.5||0.6514|TWO_SIDED|90.0|105.4|163.57|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of BI 201335 at Day 66 vs. Day 9 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 66 vs. Day 9||163.57|105.40|0.6514
72561394|NCT01525628|144653426|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 17 vs. Day 9 (%)|381.11|STANDARD_DEVIATION|28.1||1|TWO_SIDED|90.0|317.01|458.19|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of BI 201335 at Day 17 vs. Day 9 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 17 vs. Day 9||458.19|317.01|1.0000
72561395|NCT01525628|144653426|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 66 vs. Day 9 (%)|123.65|STANDARD_DEVIATION|40.0||0.4718|TWO_SIDED|90.0|94.66|161.51|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of BI 201335 at Day 66 vs. Day 9 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 66 vs. Day 9||161.51|94.66|0.4718
72561396|NCT01525628|144653427|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 17 vs. Day 9 (%)|306.45|STANDARD_DEVIATION|30.7||1|TWO_SIDED|90.0|250.93|374.26|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of BI 201335 at Day 17 vs. Day 9 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 17 vs. Day 9||374.26|250.93|1.0000
72447278|NCT00085735|144411749|NON_INFERIORITY|A hazard ratio of 1.6 is used as the non-inferiority margin. For the final analysis of comparing LDCSI vs. SDCSI, a one-sided 80% upper confidence limit of the hazard ratio based on a stratified approach will be estimated (stratified by RT group (IFRT vs. PFRT)). If the upper confidence limit is lower than 1.6, LDCSI would be deemed to be non-inferior. If not, non-inferiority would not be established.|Hazard Ratio (HR)|1.5|||||ONE_SIDED|80.0||1.9||||||The comparison is based on all eligible randomized patients 3-7 years of age without anaplastic histology or excess residual disease or disseminated disease by central review per the protocol document. Using a one-sided log rank test with type I error of 0.20, this study was designed to have power of 0.80 to detect a 10% reduction in cure rate due to the use of LDCSI compared to SDCSI.||1.9||
72447279|NCT00085735|144411749|NON_INFERIORITY|A hazard ratio of 1.6 is used as the non-inferiority margin. For the final analysis comparing IFRT vs. PFRT, a one-sided 94% upper confidence limit of the hazard ratio based on a stratified approach will be estimated (stratified by age group and RT group (LDCSI vs. SDCSI)). If the upper confidence limit is lower than 1.6, IFRT would be deemed to be non-inferior. If not, non-inferiority would not be established.|Hazard Ratio (HR)|1.0|||||ONE_SIDED|94.0||1.3||||||The comparison is based on all eligible randomized patients 3-21 years of age without anaplastic histology or excess residual disease or disseminated disease by central review as per the protocol document. Using a one-sided log rank test with type I error of 0.20, this study was designed with power of 0.94 to detect a 10% reduction in cure rate and power of 0.65 to detect a 5% reduction in cure rate, due to the use of IFRT compared to PFRT.||1.3||
72447280|NCT04971681|144411836|SUPERIORITY||||||<|0.27|||||||t-test, 2 sided|||||||<0.27
72447281|NCT04971681|144411837|SUPERIORITY||||||<|0.1|||||||t-test, 2 sided|||||||<0.10
72447282|NCT00686335|144411838|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-7.9|STANDARD_DEVIATION|6.07|||TWO_SIDED|95.0|-13.5|-2.2||As this was an explorative study to collect data for a subsequent controlled study, no hypothesis testing was performed. All analyses were descriptive.|Other|As this was an explorative study, no hypothesis testing was performed. All analyses were descriptive.||As this was an explorative study to collect data for a subsequent controlled study, no hypothesis testing was performed. All analyses were descriptive.||-2.2|-13.5|
72447283|NCT02677805|144411847|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
72447284|NCT02677805|144411848|SUPERIORITY|||||||0.087||||||For the testing a hierarchical approach has been applied. The result of this test is considered confirmative if the test of the Primary Outcome Measure shows a confirmatory result at a one-sided significance level of 0.025.|Cochran-Mantel-Haenszel|||||||0.087
72447285|NCT02677805|144411849|SUPERIORITY|||||||0.121||||||For the testing a hierarchical approach has been applied. The result of this test is considered confirmative if the test of the Primary and all previous Secondary Outcome Measures show a confirmatory result at a one-sided significance level of 0.025.|Cochran-Mantel-Haenszel|||||||0.121
72447286|NCT02677805|144411850|SUPERIORITY||||||<|0.001||||||For the testing a hierarchical approach has been applied. The result of this test is considered confirmative if the test of the Primary and all previous Secondary Outcome Measures show a confirmatory result at a one-sided significance level of 0.025.|Cochran-Mantel-Haenszel|||Test performed for Investigator's In-clinic Assessment||||<0.001
72447287|NCT02677805|144411850|SUPERIORITY||||||<|0.001||||||For the testing a hierarchical approach has been applied. The result of this test is considered confirmative if the test of the Primary and all previous Secondary Outcome Measures show a confirmatory result at a one-sided significance level of 0.025.|Cochran-Mantel-Haenszel|||Test performed for Subject's In-clinic Assessment||||<0.001
72498196|NCT00928070|144526881|SUPERIORITY_OR_OTHER||Least squares mean difference|-9.15|STANDARD_ERROR_OF_MEAN|1.88|<|0.0001|TWO_SIDED|95.0|-12.85|-5.45||Statistical testing, two-sided, was done at 5% alpha level.|ANCOVA|||Change at Week 4: ANCOVA model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.||-5.45|-12.85|<0.0001
72498197|NCT00928070|144526881|SUPERIORITY_OR_OTHER||Least squares mean difference|-7.6|STANDARD_ERROR_OF_MEAN|2.03||0.0002|TWO_SIDED|95.0|-11.6|-3.61||Statistical testing, two-sided, was done at 5% alpha level.|ANCOVA|||Change at Week 12: ANCOVA model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.||-3.61|-11.60|0.0002
72498198|NCT00928070|144526883|SUPERIORITY_OR_OTHER||Least squares mean difference|8.17|STANDARD_ERROR_OF_MEAN|2.08|<|0.0001|TWO_SIDED|95.0|4.09|12.25||Statistical testing, two-sided, was done at 5% alpha level.|ANCOVA|||Change at Week 4: concern domain- ANCOVA model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.||12.25|4.09|<0.0001
72498199|NCT00928070|144526883|SUPERIORITY_OR_OTHER||Least squares mean difference|6.96|STANDARD_ERROR_OF_MEAN|2.13||0.0012|TWO_SIDED|95.0|2.77|11.15||Statistical testing, two-sided, was done at 5% alpha level.|ANCOVA|||Change at Week 4: coping domain- ANCOVA model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.||11.15|2.77|0.0012
72498200|NCT00928070|144526883|SUPERIORITY_OR_OTHER||Least squares mean difference|4.0|STANDARD_ERROR_OF_MEAN|2.01||0.0472|TWO_SIDED|95.0|0.05|7.95||Statistical testing, two-sided, was done at 5% alpha level.|ANCOVA|||Change at Week 4: sleep domain- ANCOVA model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.||7.95|0.05|0.0472
72498201|NCT00928070|144526883|SUPERIORITY_OR_OTHER||Least squares mean difference|2.46|STANDARD_ERROR_OF_MEAN|1.53||0.1087|TWO_SIDED|95.0|-0.55|5.46||Statistical testing, two-sided, was done at 5% alpha level.|ANCOVA|||Change at Week 4: social interaction domain- ANCOVA model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.||5.46|-0.55|0.1087
72498202|NCT00928070|144526883|SUPERIORITY_OR_OTHER||Least squares mean difference|5.79|STANDARD_ERROR_OF_MEAN|1.77||0.0012|TWO_SIDED|95.0|2.31|9.28||Statistical testing, two-sided, was done at 5% alpha level.|ANCOVA|||Change at Week 4: total- ANCOVA model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.||9.28|2.31|0.0012
72498203|NCT00928070|144526883|SUPERIORITY_OR_OTHER||Least squares mean difference|9.04|STANDARD_ERROR_OF_MEAN|2.19|<|0.0001|TWO_SIDED|95.0|4.75|13.33||Statistical testing, two-sided, was done at 5% alpha level.|ANCOVA|||Change at Week 12: concern domain- ANCOVA model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.||13.33|4.75|<0.0001
72561397|NCT01525628|144653427|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 66 vs. Day 9 (%)|129.85|STANDARD_DEVIATION|32.5||0.6185|TWO_SIDED|90.0|104.26|161.71|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of BI 201335 at Day 66 vs. Day 9 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 66 vs. Day 9||161.71|104.26|0.6185
72561398|NCT01525628|144653428|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 17 vs. Day 9 (%)|286.01|STANDARD_DEVIATION|39.4||1|TWO_SIDED|90.0|228.51|357.97|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of BI 207127 at Day 17 vs. Day 9 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 17 vs. Day 9||357.97|228.51|1.0000
72447288|NCT02677805|144411851|SUPERIORITY|||||||0.218||||||For the testing a hierarchical approach has been applied. The result of this test is considered confirmative if the test of the Primary and all previous Secondary Outcome Measures show a confirmatory result at a one-sided significance level of 0.025.|Cochran-Mantel-Haenszel|||Test performed for responders rates at week 20||||0.218
72447289|NCT02677805|144411852|SUPERIORITY||||||<|0.001||||||For the testing a hierarchical approach has been applied. The result of this test is considered confirmative if the test of the Primary and all previous Secondary Outcome Measures show a confirmatory result at a one-sided significance level of 0.025.|Wilcoxon (Mann-Whitney)|||Test performed for Modified Skindex-16 (GL-QoL) Emotional domain - Change from Baseline at Week 4||||<0.001
72447290|NCT02677805|144411852|SUPERIORITY||||||<|0.001||||||For the testing a hierarchical approach has been applied. The result of this test is considered confirmative if the test of the Primary and all previous Secondary Outcome Measures show a confirmatory result at a one-sided significance level of 0.025.|Wilcoxon (Mann-Whitney)|||Test performed for Modified Skindex-16 (GL-QoL) Social Functioning domain - Change from Baseline at Week 4||||<0.001
72447291|NCT02677805|144411852|SUPERIORITY||||||<|0.001||||||For the testing a hierarchical approach has been applied. The result of this test is considered confirmative if the test of the Primary and all previous Secondary Outcome Measures show a confirmatory result at a one-sided significance level of 0.025.|Wilcoxon (Mann-Whitney)|||Test performed for Modified Skindex-16 (GL-QoL) Overall score - Change from Baseline at Week 4.||||<0.001
72447292|NCT02677805|144411852|SUPERIORITY||||||<|0.001||||||For the testing a hierarchical approach has been applied. The result of this test is considered confirmative if the test of the Primary and all previous Secondary Outcome Measures show a confirmatory result at a one-sided significance level of 0.025.|Wilcoxon (Mann-Whitney)|||Test performed for FACE-Q Appraisal of Lines Between Eyebrows - Change from Baseline at Week 4||||<0.001
72447293|NCT02677805|144411852|SUPERIORITY||||||<|0.001||||||For the testing a hierarchical approach has been applied. The result of this test is considered confirmative if the test of the Primary and all previous Secondary Outcome Measures show a confirmatory result at a one-sided significance level of 0.025.|Wilcoxon (Mann-Whitney)|||Test performed for FACE-Q Age Appraisal VAS score||||<0.001
72447294|NCT01743807|144411907|SUPERIORITY|||||||0.05|||||||t-test, 2 sided|||||||0.05
72447295|NCT03344094|144411913|OTHER|changes in subsets paired and unpaired t-tests, ANOVA||||||0.05|||||||ANOVA|||||||0.05
72447296|NCT05415722|144411919|SUPERIORITY||Mean Difference (Final Values)|-11.39|STANDARD_ERROR_OF_MEAN|7.48||0.1303|TWO_SIDED|95.0|-26.178|3.406|||ANCOVA|||Arm 1 compared to Placebo||3.406|-26.178|0.1303
72447297|NCT05415722|144411919|SUPERIORITY||Mean Difference (Final Values)|-23.47|STANDARD_ERROR_OF_MEAN|7.924||0.0036|TWO_SIDED|95.0|-39.14|-7.799|||ANCOVA|||Arm 2 compared to Placebo||-7.799|-39.140|0.0036
72447298|NCT05415722|144411919|SUPERIORITY||Mean Difference (Final Values)|-40.8|STANDARD_ERROR_OF_MEAN|7.96|<|0.0001|TWO_SIDED|95.0|-56.545|-25.064|||ANCOVA|||Arm 3 compared to Placebo||-25.064|-56.545|<0.0001
72447299|NCT05415722|144411920|SUPERIORITY||Mean Difference (Final Values)|-31.9|STANDARD_ERROR_OF_MEAN|20.87||0.1289|TWO_SIDED|95.0|-73.17|9.39|||ANCOVA|||Arm 1 compared to Placebo||9.39|-73.17|0.1289
72447300|NCT05415722|144411920|SUPERIORITY||Mean Difference (Final Values)|-29.3|STANDARD_ERROR_OF_MEAN|21.65||0.179|TWO_SIDED|95.0|-72.08|13.58|||ANCOVA|||Arm 2 compared to Placebo||13.58|-72.08|0.1790
72447301|NCT05415722|144411920|SUPERIORITY||Mean Difference (Final Values)|-75.7|STANDARD_ERROR_OF_MEAN|21.96||0.0008|TWO_SIDED|95.0|-119.08|-32.23|||ANCOVA|||Arm 3 compared to Placebo||-32.23|-119.08|0.0008
72447302|NCT05415722|144411921|SUPERIORITY||Mean Difference (Final Values)|-16.74|STANDARD_ERROR_OF_MEAN|7.895||0.0358|TWO_SIDED|95.0|-32.352|-1.128|||ANCOVA|||Arm 4 compared to Placebo||-1.128|-32.352|0.0358
72447303|NCT05415722|144411921|SUPERIORITY||Mean Difference (Final Values)|-43.73|STANDARD_ERROR_OF_MEAN|7.647|<|0.0001|TWO_SIDED|95.0|-58.858|-28.612|||ANCOVA|||Arm 5 compared to Placebo||-28.612|-58.858|<0.0001
72447304|NCT05415722|144411922|SUPERIORITY||Mean Difference (Final Values)|-62.6|STANDARD_ERROR_OF_MEAN|22.09||0.0053|TWO_SIDED|95.0|-106.33|-18.96|||ANCOVA|||Arm 4 compared to Placebo||-18.96|-106.33|0.0053
72447305|NCT05415722|144411922|SUPERIORITY||Mean Difference (Final Values)|-69.2|STANDARD_ERROR_OF_MEAN|21.13||0.0014|TWO_SIDED|95.0|-110.97|-27.39|||ANCOVA|||Arm 5 compared to Placebo||-27.39|-110.97|0.0014
72447306|NCT03031470|144411945|SUPERIORITY|||||||0.688|||||||Fisher Exact|Analysis is based on exact Fisher test to compare treatments.||||||0.688
72447307|NCT03031470|144411946|SUPERIORITY|||||||0.7|||||||Fisher Exact|Analysis is based on exact Fisher test to compare treatments.||||||0.700
72447308|NCT03031470|144411947|SUPERIORITY||||||>|0.999|||||||Fisher Exact|Treatment groups were compared for frequency of allograft nonfunction using Fisher exact test||||||>0.999
72447309|NCT03031470|144411948|SUPERIORITY|||||||0.308|||||||Fisher Exact|||||||0.308
72447310|NCT03031470|144411949|SUPERIORITY|||||||0.601|||||||Fisher Exact|||||||0.601
72447311|NCT03031470|144411951|SUPERIORITY|||||||0.574|||||||Cochran-Mantel-Haenszel|Reparixin and Control groups will be compared for degree of allograft steatosis using Cochran-Mantel-Hensel (CMH) test with control EAD.||||||0.574
72447312|NCT03031470|144411952|SUPERIORITY|||||||0.843|||||||Cochran-Mantel-Haenszel|Reparixin and Control groups will be compared for duration of cold ischemia using Cochran-Mantel-Hensel (CMH) test with control EAD.||||||0.843
72498204|NCT00928070|144526883|SUPERIORITY_OR_OTHER||Least squares mean difference|5.32|STANDARD_ERROR_OF_MEAN|2.22||0.0169|TWO_SIDED|95.0|0.96|9.67||Statistical testing, two-sided, was done at 5% alpha level.|ANCOVA|||Change at Week 12: coping domain- ANCOVA model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.||9.67|0.96|0.0169
72447313|NCT03031470|144411953|SUPERIORITY|||||||0.701|||||||Cochran-Mantel-Haenszel|Reparixin and Control groups will be compared for duration of earm ischemia using Cochran-Mantel-Hensel (CMH) test with control EAD.||||||0.701
72447314|NCT03031470|144411963|SUPERIORITY|"General survival and graft survival (graft loss will be qualified as an event for graft survival) within 1 year were presented with Kaplan-Mayer curves and survival time median with 95% CI. Treatment groups will be compared using logrank test."||||||0.416|||||||Log Rank|||||||0.416
72447315|NCT02310646|144411982|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2||||||Treatment sequence effect: p=0.28; gender effect: p=0.20; threshold for statistical significance: p\<0.05|Regression, Logistic|2-factor logistic regression model with treatment sequence and gender as factors.||"The statistical significance of each of the 7 baseline characteristics was tested in a 2-factor logistic regression model with treatment sequence and each baseline characteristic as factors.~Baseline factor: gender (male, female)."||||0.2
72447316|NCT02310646|144411982|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.001||||||Treatment sequence effect: p=0.34; age effect: p=0.001; threshold for statistical significance: p\<0.05.|Regression, Logistic|2-factor logistic regression with age and treatment sequence as factors||"The statistical significance of each of the 7 baseline characteristics was tested in a 2-factor logistic regression model with treatment sequence and each baseline characteristic as factors.~Baseline factor: age (18-39 years, 40-59 years, ≥60 years)."||||=0.001
72447317|NCT02310646|144411982|SUPERIORITY_OR_OTHER_LEGACY|||||||0.29||||||Treatment sequence effect: p=0.34; baseline disease severity effect: p=0.29; threshold for statistical significance: p\<0.05|Regression, Logistic|2-factor logistic regression model with treatment sequence and baseline disease severity as factors.||"The statistical significance of each of the 7 baseline characteristics was tested in a 2-factor logistic regression model with treatment sequence and each baseline characteristic as factors.~Baseline factor: Baseline disease severity (mild, moderate, severe)."||||0.29
72447318|NCT02310646|144411982|SUPERIORITY_OR_OTHER_LEGACY|||||||0.55||||||Treatment sequence effect: p=0.33; distribution phenotype (localised, widespread) effect: p=0.55; threshold for statistical significance: p\<0.05|Regression, Logistic|2-factor logistic regression model with treatment sequence and distribution phenotype (localised, widespread) as factors.||"The statistical significance of each of the 7 baseline characteristics was tested in a 2-factor logistic regression model with treatment sequence and each baseline characteristic as factors.~Baseline factor: distribution phenotype (localised, widespread)."||||0.55
72447319|NCT02310646|144411982|SUPERIORITY_OR_OTHER_LEGACY|||||||0.25||||||Treatment sequence effect: p=0.32; plaque size (≤3 mm diameter, \>3 mm diameter): p=0.25; threshold for statistical significance: p\<0.05|Regression, Logistic|2-factor logistic regression model with treatment sequence and plaque size as factors.||"The statistical significance of each of the 7 baseline characteristics was tested in a 2-factor logistic regression model with treatment sequence and each baseline characteristic as factors.~Baseline factor: plaque size (≤3 mm diameter, \>3 mm diameter)."||||0.25
72447320|NCT02310646|144411982|SUPERIORITY_OR_OTHER_LEGACY|||||||0.41||||||Treatment sequence effect: p=0.34; skin thickness phenotype (≤0.75 mm, \>0.75 mm) effect: p=0.41; threshold for statistical significance: p\<0.05|Regression, Logistic|2-factor logistic regression model with treatment sequence and skin thickness phenotype as factors.||"The statistical significance of each of the 7 baseline characteristics was tested in a 2-factor logistic regression model with treatment sequence and each baseline characteristic as factors.~Baseline factor: skin thickness phenotype (≤0.75 mm, \>0.75 mm)."||||0.41
72498205|NCT00928070|144526883|SUPERIORITY_OR_OTHER||Least squares mean difference|4.05|STANDARD_ERROR_OF_MEAN|2.1||0.0546|TWO_SIDED|95.0|-0.08|8.17||Statistical testing, two-sided, was done at 5% alpha level.|ANCOVA|||Change at Week 12: sleep domain- ANCOVA model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.||8.17|-0.08|0.0546
72498206|NCT00928070|144526883|SUPERIORITY_OR_OTHER||Least squares mean difference|2.35|STANDARD_ERROR_OF_MEAN|1.63||0.1497|TWO_SIDED|95.0|-0.85|5.55||Statistical testing, two-sided, was done at 5% alpha level.|ANCOVA|||Change at Week 12: social interaction domain- ANCOVA model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.||5.55|-0.85|0.1497
72498207|NCT00928070|144526883|SUPERIORITY_OR_OTHER||Least squares mean difference|5.53|STANDARD_ERROR_OF_MEAN|1.88||0.0034|TWO_SIDED|95.0|1.84|9.23||Statistical testing, two-sided, was done at 5% alpha level.|ANCOVA|||Change at Week 12: total- ANCOVA model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.||9.23|1.84|0.0034
72498208|NCT00928070|144526884|SUPERIORITY_OR_OTHER||Least squares mean difference|16.25|STANDARD_ERROR_OF_MEAN|2.96|<|0.0001|TWO_SIDED|95.0|10.43|22.08||Statistical testing, two-sided, was done at 5% significance level.|ANOVA|||ANOVA model with treatment and center as factors was used to calculate p-value.||22.08|10.43|<0.0001
72498209|NCT00928070|144526885|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Statistical testing, two-sided, was done at 5% alpha level.|Cochran-Mantel-Haenszel|||Not satisfied, neither dissatisfied nor satisfied, satisfied: CMH test with modified ridit scoring controlling for center was used.||||<0.0001
72498210|NCT00928070|144526887|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.18|STANDARD_ERROR_OF_MEAN|0.17||0.2788|TWO_SIDED|95.0|-0.51|0.15||Statistical testing, two-sided, was done at 5% alpha level.|ANCOVA|||ANCOVA model with terms for treatment, center, centered baseline value, and centered baseline by treatment interaction.||0.15|-0.51|0.2788
72447321|NCT02310646|144411982|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2||||||Treatment sequence effect: p=0.30; onset phenotype (≤40 years of age, \>40 years of age) effect: p=0.20; threshold for statistical significance: p\<0.05|Regression, Logistic|2-factor logistic regression model with treatment sequence and onset phenotype (≤40 years of age, \>40 years of age) as factors.||"The statistical significance of each of the 7 baseline characteristics was tested in a 2-factor logistic regression model with treatment sequence and each baseline characteristic as factors.~Baseline factor: onset phenotype (≤40 years of age, \>40 years of age)."||||0.20
72447322|NCT02310646|144411983|SUPERIORITY_OR_OTHER_LEGACY|||||||0.007||||||"The total TPUQ score for the gel and the foam (mean score 29.9 vs. mean score 26.8; p=0.007).~Threshold for statistical significance: p\<0.05."|Wilcoxon Rank Sum Test|Wilcoxon rank sum test comparing the period difference (within subject difference between study treatments) between both treatment sequences.||Subjects in the analysis are 212 - full analysis set. All subjects received both study treatments. Total TPUQ score (summary score item 1-25) superiority comparison gel versus foam.||||0.007
72447323|NCT02310646|144411984|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Wilcoxon Signed Rank Test|Wilcoxon signed rank test comparing within subject difference to latest topical treatment||Subjects in the analysis are 118. All subjects received both study treatments. Statistical analysis for total TPUQ score (summary score item 1-25): superiority comparison foam versus latest topical treatment.||||<0.001
72447324|NCT02310646|144411984|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Wilcoxon Signed Rank Test|Wilcoxon signed rank test comparing within subject difference to latest topical treatment||Subjects in the analysis are 118. All subjects received both study treatments. Statistical analysis for total TPUQ score (summary score item 1-25): superiority comparison gel versus latest topical treatment.||||<0.001
72447325|NCT03848065|144411988|OTHER||Difference in Percentages|17.8||||0.004|TWO_SIDED|95.0|9.0|31.4|||Miettinen & Nurminen method||Difference = % V114-SC minus % V114-IM|Injection Site Erythema (Redness)||31.4|9.0|0.004
72447326|NCT03848065|144411988|OTHER||Difference in Percentages|4.7||||0.15|TWO_SIDED|95.0|-3.7|15.5|||Miettinen & Nurminen method||Difference = % V114-SC minus % PCV13-SC|Injection Site Erythema (Redness)||15.5|-3.7|0.150
72447327|NCT03848065|144411988|OTHER||Difference in Percentages|-13.1||||0.054|TWO_SIDED|95.0|-27.6|0.2|||Miettinen & Nurminen method||Difference = % V114-IM minus % PCV13-SC|Injection Site Erythema (Redness)||0.2|-27.6|0.054
72498211|NCT00928070|144526888|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|4.0||||0.0021|TWO_SIDED|95.0|0.0|8.0||Statistical testing, two-sided, was done at 5% alpha level.|Van Elteren's test|||Change at Week 4: Van Elteren's test adjusted by baseline PVR quartile was used to calculate p-value. The median difference was based on Hodges-Lehmann estimate.||8.00|0.00|0.0021
72498212|NCT00928070|144526888|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|7.0|||<|0.0001|TWO_SIDED|95.0|3.0|11.0||Statistical testing, two-sided, was done at 5% alpha level.|Van Elteren's test|||Change at Week 12: Van Elteren's test adjusted by baseline PVR quartile was used to calculate p-value. The median difference was based on Hodges-Lehmann estimate.||11.00|3.00|<0.0001
72498213|NCT00862251|144526897|SUPERIORITY_OR_OTHER_LEGACY||Percent change in least-square means|-14.76|||<|0.001|TWO_SIDED|95.0|-19.61|-9.91|||Longitudinal data analysis (LDA)|||||-9.91|-19.61|<0.001
72498214|NCT00862251|144526898|SUPERIORITY_OR_OTHER_LEGACY||Percent change in Least Square Means|-13.62|||<|0.001|TWO_SIDED|95.0|-20.44|-6.79|||Longitudinal data analysis (LDA)|||||-6.79|-20.44|<0.001
72498215|NCT00862251|144526899|SUPERIORITY_OR_OTHER_LEGACY||Percent change in least squares mean|-15.73|||<|0.001|TWO_SIDED|95.0|-22.65|-8.81|||Longitudinal Data Analysis (LDA)|||||-8.81|-22.65|<0.001
72498216|NCT00862251|144526900|SUPERIORITY_OR_OTHER_LEGACY||Percent Change in Least Squares Means|-3.81||||0.06|TWO_SIDED|95.0|-7.78|0.17|||Longitudinal Data Analysis|||||0.17|-7.78|0.060
72498217|NCT00862251|144526901|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|3.9|||<|0.001|TWO_SIDED|95.0|2.5|6.2|||Regression, Logistic|||||6.2|2.5|<0.001
72447328|NCT03848065|144411988|OTHER||Difference in Percentages|13.1||||0.091|TWO_SIDED|95.0|-2.3|28.8|||Miettinen & Nurminen method||Difference = % V114-SC minus % V114-IM|Injection Site Induration (Hard Lump)||28.8|-2.3|0.091
72447329|NCT03848065|144411988|OTHER||Difference in Percentages|-9.1||||0.044|TWO_SIDED|95.0|-21.2|-0.4|||Miettinen & Nurminen method||Difference = % V114-SC minus % PCV13-SC|Injection Site Induration (Hard Lump)||-0.4|-21.2|0.044
72498218|NCT00862251|144526901|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.9|||<|0.001|TWO_SIDED|95.0|1.3|2.6|||Regression, Logistic|||||2.6|1.3|<0.001
72498219|NCT00862251|144526902|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|4.5|||<|0.001|TWO_SIDED|95.0|2.3|8.5|||Regression, Logistic|||||8.5|2.3|<0.001
72390393|NCT04115839|144288576|SUPERIORITY||Difference in response rates|-8.8||||0.27|TWO_SIDED|95.0|-27.7|10.1||P-value was calculated from the logistic regression with treatment groups and stratification factors (geographic region, concurrent use of csDMARD(s) and/or apremilast at randomization, prior use of bioDMARD(s)) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 12||10.1|-27.7|0.27
72390394|NCT04115839|144288576|SUPERIORITY||Difference in response rates|40.7||||0.002|TWO_SIDED|95.0|19.5|62.0||P-value was calculated from the logistic regression with treatment groups and stratification factors (geographic region, concurrent use of csDMARD(s) and/or apremilast at randomization, prior use of bioDMARD(s)) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||62.0|19.5|0.002
72390395|NCT04115839|144288576|SUPERIORITY||Difference in response rates|15.2||||0.082|TWO_SIDED|95.0|-2.3|32.6||P-value was calculated from the logistic regression with treatment groups and stratification factors (geographic region, concurrent use of csDMARD(s) and/or apremilast at randomization, prior use of bioDMARD(s)) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||32.6|-2.3|0.082
72390396|NCT04115839|144288578|SUPERIORITY||Difference in response rates|2.9|||||TWO_SIDED|95.0|-5.6|11.5|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 2||11.5|-5.6|
72390397|NCT04115839|144288578|SUPERIORITY||Difference in response rates|0.0|||||TWO_SIDED|95.0|-2.9|2.9|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 2||2.9|-2.9|
72561399|NCT01525628|144653428|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 66 vs. Day 9 (%)|150.45|STANDARD_DEVIATION|55.1||0.821|TWO_SIDED|90.0|106.81|211.91|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of BI 207127 at Day 66 vs. Day 9 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 66 vs. Day 9||211.91|106.81|0.8210
72561400|NCT01525628|144653429|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 17 vs. Day 9 (%)|349.9|STANDARD_DEVIATION|46.4||1|TWO_SIDED|90.0|269.12|454.93|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of BI 207127 at Day 17 vs. Day 9 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 17 vs. Day 9||454.93|269.12|1.0000
72561401|NCT01525628|144653429|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 66 vs. Day 9 (%)|176.56|STANDARD_DEVIATION|50.1||0.9533|TWO_SIDED|90.0|125.95|247.5|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of BI 207127 at Day 66 vs. Day 9 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 66 vs. Day 9||247.50|125.95|0.9533
72390398|NCT04115839|144288578|SUPERIORITY||Difference in response rates|2.8|||||TWO_SIDED|95.0|-5.4|11.0|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||11.0|-5.4|
72390399|NCT04115839|144288578|SUPERIORITY||Difference in response rates|0.0|||||TWO_SIDED|95.0|-2.9|2.9|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||2.9|-2.9|
72390400|NCT04115839|144288578|SUPERIORITY||Difference in response rates|12.7|||||TWO_SIDED|95.0|-4.2|29.5|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 8||29.5|-4.2|
72390401|NCT04115839|144288578|SUPERIORITY||Difference in response rates|-2.9|||||TWO_SIDED|95.0|-11.6|5.7|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 8||5.7|-11.6|
72390402|NCT04115839|144288578|SUPERIORITY||Difference in response rates|18.3|||||TWO_SIDED|95.0|0.2|36.3|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 12||36.3|0.2|
72390403|NCT04115839|144288578|SUPERIORITY||Difference in response rates|2.9|||||TWO_SIDED|95.0|-9.7|15.6|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 12||15.6|-9.7|
72390404|NCT04115839|144288578|SUPERIORITY||Difference in response rates|12.5|||||TWO_SIDED|95.0|-2.0|27.0|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||27.0|-2.0|
72390405|NCT04115839|144288578|SUPERIORITY||Difference in response rates|9.1|||||TWO_SIDED|95.0|-3.7|21.9|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||21.9|-3.7|
72390406|NCT04115839|144288594|SUPERIORITY||Difference in response rates|9.5|||||TWO_SIDED|95.0|-10.4|29.4|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 2||29.4|-10.4|
72447330|NCT03848065|144411988|OTHER||Difference in Percentages|-22.2||||0.001|TWO_SIDED|95.0|-36.4|-12.5|||Miettinen & Nurminen method||Difference = % V114-IM minus % PCV13-SC|Injection Site Induration (Hard Lump)||-12.5|-36.4|0.001
72447331|NCT03848065|144411988|OTHER||Difference in Percentages|9.7||||0.333|TWO_SIDED|95.0|-10.0|28.9|||Miettinen & Nurminen method||Difference = % V114-SC minus % V114-IM|Injection Site Pain||28.9|-10.0|0.333
72390407|NCT04115839|144288594|SUPERIORITY||Difference in response rates|7.1|||||TWO_SIDED|95.0|-12.5|26.7|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 2||26.7|-12.5|
72390408|NCT04115839|144288594|SUPERIORITY||Difference in response rates|20.0|||||TWO_SIDED|95.0|-3.8|43.8|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||43.8|-3.8|
72390409|NCT04115839|144288594|SUPERIORITY||Difference in response rates|6.5|||||TWO_SIDED|95.0|-16.3|29.3|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||29.3|-16.3|
72390410|NCT04115839|144288594|SUPERIORITY||Difference in response rates|17.8|||||TWO_SIDED|95.0|-8.8|44.5|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 8||44.5|-8.8|
72390411|NCT04115839|144288594|SUPERIORITY||Difference in response rates|2.9|||||TWO_SIDED|95.0|-22.9|28.8|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 8||28.8|-22.9|
72390412|NCT04115839|144288594|SUPERIORITY||Difference in response rates|25.0|||||TWO_SIDED|95.0|-0.5|50.6|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 12||50.6|-0.5|
72390413|NCT04115839|144288594|SUPERIORITY||Difference in response rates|14.7|||||TWO_SIDED|95.0|-10.5|39.9|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 12||39.9|-10.5|
72390414|NCT04115839|144288594|SUPERIORITY||Difference in response rates|18.5|||||TWO_SIDED|95.0|-8.7|45.6|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||45.6|-8.7|
72390415|NCT04115839|144288594|SUPERIORITY||Difference in response rates|6.1|||||TWO_SIDED|95.0|-20.5|32.6|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||32.6|-20.5|
72390416|NCT04115839|144288596|SUPERIORITY||Difference in response rates|9.0|||||TWO_SIDED|95.0|-6.0|23.9|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 2||23.9|-6.0|
72390417|NCT04115839|144288596|SUPERIORITY||Difference in response rates|3.3|||||TWO_SIDED|95.0|-9.4|15.9|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 2||15.9|-9.4|
72390418|NCT04115839|144288596|SUPERIORITY||Difference in response rates|5.7|||||TWO_SIDED|95.0|-14.7|26.2|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||26.2|-14.7|
72447332|NCT03848065|144411988|OTHER||Difference in Percentages|-3.2||||0.76|TWO_SIDED|95.0|-23.4|17.2|||Miettinen & Nurminen method||Difference = % V114-SC minus % PCV13-SC|Injection Site Pain||17.2|-23.4|0.760
72447333|NCT03848065|144411988|OTHER||Difference in Percentages|-13.0||||0.205|TWO_SIDED|95.0|-32.2|7.1|||Miettinen & Nurminen method||Difference = % V114-IM minus % PCV13-SC|Injection Site Pain||7.1|-32.2|0.205
72447334|NCT03848065|144411988|OTHER||Difference in Percentages|13.0||||0.128|TWO_SIDED|95.0|-3.9|29.7|||Miettinen & Nurminen method||Difference = % V114-SC minus % V114-IM|Injection Site Swelling||29.7|-3.9|0.128
72447335|NCT03848065|144411988|OTHER||Difference in Percentages|-2.0||||0.779|TWO_SIDED|95.0|-17.0|13.0|||Miettinen & Nurminen method||Difference = % V114-SC minus % PCV13-SC|Injection Site Swelling||13.0|-17.0|0.779
72447336|NCT03848065|144411988|OTHER||Difference in Parentages|-15.0||||0.076|TWO_SIDED|95.0|-31.5|1.7|||Miettinen & Nurminen method||Difference = % V114-IM minus % PCV13-SC|Injection Site Swelling||1.7|-31.5|0.076
72447337|NCT03848065|144411989|OTHER||Difference in Percentages|-10.6||||0.282|TWO_SIDED|95.0|-29.1|8.7|||Miettinen & Nurminen method||Difference = % V114-SC minus % V114-IM|Decreased Appetite (Appetite Loss)||8.7|-29.1|0.282
72447338|NCT03848065|144411989|OTHER||Difference in Percentages|-9.9||||0.317|TWO_SIDED|95.0|-28.7|9.5|||Miettinen & Nurminen method||Difference= % V114-SC minus % PCV13-SC|Decreased Appetite (Appetite Loss)||9.5|-28.7|0.317
72447339|NCT03848065|144411989|OTHER||Difference in Percentages|0.7||||0.948|TWO_SIDED|95.0|-19.2|20.4|||Miettinen & Nurminen method||Difference= % V114-IM minus % PCV13-SC|Decreased Appetite (Appetite Loss)||20.4|-19.2|0.948
72561402|NCT01525628|144653430|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 17 vs. Day 9 (%)|322.68|STANDARD_DEVIATION|40.4||1|TWO_SIDED|90.0|256.24|406.34|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of BI 207127 at Day 17 vs. Day 9 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 17 vs. Day 9||406.34|256.24|1.0000
72561403|NCT01525628|144653430|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 66 vs. Day 9 (%)|145.93|STANDARD_DEVIATION|66.2||0.7461|TWO_SIDED|90.0|97.83|217.69|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of BI 207127 at Day 66 vs. Day 9 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 66 vs. Day 9||217.69|97.83|0.7461
72561404|NCT01525628|144653431|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 17 vs. Day 9 (%)|355.04|STANDARD_DEVIATION|29.9||1|TWO_SIDED|90.0|298.13|422.83|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of BI 208833 at Day 17 vs. Day 9 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 17 vs. Day 9||422.83|298.13|1.0000
72447340|NCT03848065|144411989|OTHER||Difference in Percentages|10.5||||0.303|TWO_SIDED|95.0|-9.4|29.6|||Miettinen & Nurminen method||Difference = % V114-SC minus % V114-IM|Somnolence (Drowsiness)||29.6|-9.4|0.303
72447341|NCT03848065|144411989|OTHER||Difference in Percentages|-4.0||||0.681|TWO_SIDED|95.0|-22.6|15.0|||Miettinen & Nurminen method||Difference= % V114-SC minus % PCV13-SC|Somnolence (Drowsiness)||15.0|-22.6|0.681
72447342|NCT03848065|144411989|OTHER||Difference in Percentages|-14.4||||0.153|TWO_SIDED|95.0|-33.2|5.4|||Miettinen & Nurminen method||Difference= % V114-IM minus % PCV13-SC|Somnolence (Drowsiness)||5.4|-33.2|0.153
72447343|NCT03848065|144411989|OTHER||Difference in Percentages|10.7||||0.237|TWO_SIDED|95.0|-7.2|28.2|||Miettinen & Nurminen method||Difference = % V114-SC minus % V114-IM|Irritability||28.2|-7.2|0.237
72447344|NCT03848065|144411989|OTHER||Difference in Percentages|7.4||||0.406|TWO_SIDED|95.0|-10.3|25.0|||Miettinen & Nurminen method||Difference= % V114-SC minus % PCV13-SC|Irritability||25.0|-10.3|0.406
72447345|NCT03848065|144411989|OTHER||Difference in Percentages|-3.3||||0.729|TWO_SIDED|95.0|-21.8|15.5|||Miettinen & Nurminen method||Difference= % V114-IM minus % PCV13-SC|Irritability||15.5|-21.8|0.729
72447346|NCT03848065|144411989|OTHER||Difference in Percentages|4.6||||0.385|TWO_SIDED|95.0|-7.1|17.5|||Miettinen & Nurminen method||Difference = % V114-SC minus % V114-IM|Urticaria (Hives/Welts)||17.5|-7.1|0.385
72447347|NCT03848065|144411989|OTHER||Difference in Percentages|2.1||||0.719|TWO_SIDED|95.0|-11.0|15.4|||Miettinen & Nurminen method||Difference= % V114-SC minus % PCV13-SC|Urticaria (Hives/Welts)||15.4|-11.0|0.719
72447348|NCT03848065|144411989|OTHER||Difference in Percentages|-2.5||||0.61|TWO_SIDED|95.0|-14.9|8.9|||Miettinen & Nurminen method||Difference= % V114-IM minus % PCV13-SC|Urticaria (Hives/Welts)||8.9|-14.9|0.610
72447349|NCT03848065|144411991|OTHER||Difference in Percentages|0.0|||||TWO_SIDED|95.0|-8.1|8.5|||||Difference = % V114-SC minus % PCV13-SC. The 95% CI is based on the Miettinen and Nurminen method.|ST 1||8.5|-8.1|
72447350|NCT03848065|144411991|OTHER||Difference in Percentages|0.0|||||TWO_SIDED|95.0|-7.9|8.5|||||Difference=% V114-IM minus % PCV13-SC. The 95% CI is based on the Miettinen and Nurminen method.|ST 1||8.5|-7.9|
72447351|NCT03848065|144411991|OTHER||Difference in Percentages|0.0|||||TWO_SIDED|95.0|-8.1|7.9|||||Difference=% V114-SC minus % V114-IM. The 95% CI is based on the Miettinen and Nurminen method.|ST 1||7.9|-8.1|
72447352|NCT03848065|144411991|OTHER||Difference in Percentages|0.0|||||TWO_SIDED|95.0|-8.1|8.5|||||Difference = % V114- SC minus % PCV13-SC. The 95% CI is based on the Miettinen and Nurminen method.|ST 3||8.5|-8.1|
72447353|NCT03848065|144411991|OTHER||Difference in Percentages|-2.2|||||TWO_SIDED|95.0|-11.7|6.3|||||Difference=% V114-IM minus % PCV13-SC. The 95% CI is based on the Miettinen and Nurminen method.|ST 3||6.3|-11.7|
72447354|NCT03848065|144411991|OTHER||Difference in Percentages|2.2|||||TWO_SIDED|95.0|-6.0|11.6|||||Difference=% V114-SC minus % V114-IM. The 95% CI is based on the Miettinen and Nurminen method.|ST 3||11.6|-6.0|
72447355|NCT03848065|144411991|OTHER||Difference in Percentages|0.0|||||TWO_SIDED|95.0|-8.1|8.5|||||Difference=% V114-SC minus % PCV13-SC. The 95% CI is based on the Miettinen and Nurminen method.|ST 4||8.5|-8.1|
72447356|NCT03848065|144411991|OTHER||Difference in Percentages|0.0|||||TWO_SIDED|95.0|-7.9|8.5|||||Difference=% V114-IM minus % PCV13-SC. The 95% CI is based on the Miettinen and Nurminen method.|ST 4||8.5|-7.9|
72447357|NCT03848065|144411991|OTHER||Difference in Percentages|0.0|||||TWO_SIDED|95.0|-8.1|7.9|||||Difference=% V114-SC minus % V114-IM. The 95% CI is based on the Miettinen and Nurminen method.|ST 4||7.9|-8.1|
72447358|NCT03848065|144411991|OTHER||Difference in Percentages|0.0|||||TWO_SIDED|95.0|-8.1|8.5|||||Difference = % V114-SC minus % PCV13-SC. The 95% CI is based on the Miettinen and Nurminen method.|ST 5||8.5|-8.1|
72447359|NCT03848065|144411991|OTHER||Difference in Percentages|0.0|||||TWO_SIDED|95.0|-7.9|8.5|||||Difference=% V114-IM minus % PCV13-SC. The 95% CI is based on the Miettinen and Nurminen method.|ST 5||8.5|-7.9|
72447360|NCT03848065|144411991|OTHER||Difference in Percentages|0.0|||||TWO_SIDED|95.0|-8.1|7.9|||||Difference=% V114-SC minus % V114-IM. The 95% CI is based on the Miettinen and Nurminen method.|ST 5||7.9|-8.1|
72447361|NCT03848065|144411991|OTHER||Difference in Percentages|-2.3|||||TWO_SIDED|95.0|-11.9|6.3|||||Difference = % V114-SC minus % PCV13-SC. The 95% CI is based on the Miettinen and Nurminen method.|ST 6A||6.3|-11.9|
72447362|NCT03848065|144411991|OTHER||Difference in Percentages|0.0|||||TWO_SIDED|95.0|-7.9|8.5|||||Difference=% V114-IM minus % PCV13-SC. The 95% CI is based on the Miettinen and Nurminen method.|ST 6A||8.5|-7.9|
72447363|NCT03848065|144411991|OTHER||Difference in Percentages|-2.3|||||TWO_SIDED|95.0|-11.9|5.8|||||Difference=% V114-SC minus % V114-IM. The 95% CI is based on the Miettinen and Nurminen method.|ST 6A||5.8|-11.9|
72447364|NCT03848065|144411991|OTHER||Difference in Percentages|-9.1|||||TWO_SIDED|95.0|-21.2|-0.2|||||Difference = % V114-SC minus % PCV13-SC. The 95% CI is based on the Miettinen and Nurminen method.|ST 6B||-0.2|-21.2|
72447365|NCT03848065|144411991|OTHER||Difference in Percentages|-6.7|||||TWO_SIDED|95.0|-17.9|2.1|||||Difference=% V114-IM minus % PCV13-SC. The 95% CI is based on the Miettinen and Nurminen method.|ST 6B||2.1|-17.9|
72447366|NCT03848065|144411991|OTHER||Difference in Percentages|-2.4|||||TWO_SIDED|95.0|-15.6|10.2|||||Difference=% V114 SC minus % V114 IM. The 95% CI is based on the Miettinen and Nurminen method.|ST 6B||10.2|-15.6|
72447367|NCT03848065|144411991|OTHER||Difference in Percentages|0.0|||||TWO_SIDED|95.0|-8.1|8.5|||||Difference = % V114 SC minus % PCV13-SC. The 95% CI is based on the Miettinen and Nurminen method.|ST 7F||8.5|-8.1|
72447368|NCT03848065|144411991|OTHER||Difference in Percentages|-2.2|||||TWO_SIDED|95.0|-11.7|6.3|||||Difference=% V114-IM minus % PCV13-SC. The 95% CI is based on the Miettinen and Nurminen method.|ST 7F||6.3|-11.7|
72447369|NCT03848065|144411991|OTHER||Difference in Percentages|2.2|||||TWO_SIDED|95.0|-6.0|11.6|||||Difference=% V114-SC minus % V114-IM. The 95% CI is based on the Miettinen and Nurminen method.|ST 7F||11.6|-6.0|
72447370|NCT03848065|144411991|OTHER||Differences in Percentages|0.0|||||TWO_SIDED|95.0|-8.1|8.5|||||Difference = % V114-SC minus % PCV13-SC. The 95% CI is based on the Miettinen and Nurminen method.|ST 9V||8.5|-8.1|
72447371|NCT03848065|144411991|OTHER||Difference in Percentages|0.0|||||TWO_SIDED|95.0|-7.9|8.5|||||Difference=% V114-IM minus % PCV13-SC. The 95% CI is based on the Miettinen and Nurminen method.|ST 9V||8.5|-7.9|
72447372|NCT03848065|144411991|OTHER||Difference in Percentages|0.0|||||TWO_SIDED|95.0|-8.1|7.9|||||Difference=% V114-SC minus % V114-IM. The 95% CI is based on the Miettinen and Nurminen method.|ST 9V||7.9|-8.1|
72447373|NCT03848065|144411991|OTHER||Difference in Percentages|-2.3|||||TWO_SIDED|95.0|-11.9|6.3|||||Difference = % V114-SC minus % PCV13-SC. The 95% CI is based on the Miettinen and Nurminen method.|ST 14||6.3|-11.9|
72447374|NCT03848065|144411991|OTHER||Difference in Percentages|0.0|||||TWO_SIDED|95.0|-7.9|8.5|||||Difference=% V114-IM minus % PCV13-SC. The 95% CI is based on the Miettinen and Nurminen method.|ST 14||8.5|-7.9|
72447375|NCT03848065|144411991|OTHER||Difference in Percentages|-2.3|||||TWO_SIDED|95.0|-11.9|5.8|||||Difference=% V114-SC minus % V114-IM. The 95% CI is based on the Miettinen and Nurminen method.|ST 14||5.8|-11.9|
72447376|NCT03848065|144411991|OTHER||Difference in Percentages|0.0|||||TWO_SIDED|95.0|-8.1|8.5|||||Difference = % V114-SC minus % PCV13-SC. The 95% CI is based on the Miettinen and Nurminen method.|ST 18C||8.5|-8.1|
72447377|NCT03848065|144411991|OTHER||Difference in Percentages|0.0|||||TWO_SIDED|95.0|-7.9|8.5|||||Difference=% V114-IM minus % PCV13-SC. The 95% CI is based on the Miettinen and Nurminen method.|ST 18C||8.5|-7.9|
72447378|NCT03848065|144411991|OTHER||Differences in Percentages|0.0|||||TWO_SIDED|95.0|-8.1|7.9|||||Difference=% V114-SC minus % V114-IM. The 95% CI is based on the Miettinen and Nurminen method.|ST 18C||7.9|-8.1|
72447379|NCT03848065|144411991|OTHER||Difference in Percentages|0.0|||||TWO_SIDED|95.0|-8.1|8.5|||||Difference=% V114-SC minus % PCV13-SC. The 95% CI is based on the Miettinen and Nurminen method.|ST 19A||8.5|-8.1|
72447380|NCT03848065|144411991|OTHER||Difference in Percentages|0.0|||||TWO_SIDED|95.0|-7.9|8.5|||||Difference=% V114-IM minus % PCV13-SC. The 95% CI is based on the Miettinen and Nurminen method.|ST 19A||8.5|-7.9|
72498220|NCT00862251|144526903|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|3.5|||<|0.001|TWO_SIDED|95.0|1.9|6.6|||Regression, Logistic|||||6.6|1.9|<0.001
72447381|NCT03848065|144411991|OTHER||Difference in Percentages|0.0|||||TWO_SIDED|95.0|-8.1|7.9|||||Difference=% V114-SC minus % V114-IM. The 95% CI is based on the Miettinen and Nurminen method.|ST 19A||7.9|-8.1|
72447382|NCT03848065|144411991|OTHER||Difference in Percentages|0.0|||||TWO_SIDED|95.0|-8.1|8.5|||||Difference=% V114-SC minus % PCV13-SC. The 95% CI is based on the Miettinen and Nurminen method.|ST 19F||8.5|-8.1|
72447383|NCT03848065|144411991|OTHER||Difference in Percentages|0.0|||||TWO_SIDED|95.0|-7.9|8.5|||||Difference=% V114-IM minus % PCV13-SC. The 95% CI is based on the Miettinen and Nurminen method.|ST 19F||8.5|-7.9|
72447384|NCT03848065|144411991|OTHER||Difference in Percentages|0.0|||||TWO_SIDED|95.0|-8.1|7.9|||||Difference=% V114-SC minus % V114-IM. The 95% CI is based on the Miettinen and Nurminen method.|ST 19F||7.9|-8.1|
72447385|NCT03848065|144411991|OTHER||Difference in Percentages|0.1|||||TWO_SIDED|95.0|-9.8|10.4|||||Difference=% V114-SC minus % PCV13-SC. The 95% CI is based on the Miettinen and Nurminen method.|ST 23F||10.4|-9.8|
72447386|NCT03848065|144411991|OTHER||Difference in Percentages|2.4|||||TWO_SIDED|95.0|-5.7|12.4|||||Difference=% V114-IM minus % PCV13-SC. The 95% CI is based on the Miettinen and Nurminen method.|ST 23F||12.4|-5.7|
72447387|NCT03848065|144411991|OTHER||Difference in Percentages|-2.3|||||TWO_SIDED|95.0|-11.9|5.8|||||Difference=% V114-SC minus % V114-IM. The 95% CI is based on the Miettinen and Nurminen method.|ST 23F||5.8|-11.9|
72447388|NCT03848065|144411991|OTHER||Difference in Percentages|90.7|||||TWO_SIDED|95.0|77.2|96.4|||||Difference=% V114-SC minus % PCV13-SC. The 95% CI is based on the Miettinen and Nurminen method.|ST 22F||96.4|77.2|
72498221|NCT00862251|144526904|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-8.33|||<|0.001|TWO_SIDED|95.0|-11.38|-5.28|||Longitudinal data analysis (LDA)|||||-5.28|-11.38|<0.001
72498222|NCT00862251|144526904|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-2.63||||0.039|TWO_SIDED|95.0|-5.13|-0.13|||Longitudinal data analysis (LDA)|||||-0.13|-5.13|0.039
72498223|NCT00862251|144526905|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-2.88||||0.316|TWO_SIDED|95.0|-8.53|2.77|||Longitudinal data analysis (LDA)|||||2.77|-8.53|0.316
72498224|NCT00862251|144526905|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-2.16||||0.356|TWO_SIDED|95.0|-6.75|2.43|||Longitudinal data analysis (LDA)|||||2.43|-6.75|0.356
72498225|NCT00862251|144526906|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|0.47||||0.756|TWO_SIDED|95.0|-2.5|3.45|||Longitudinal data analysis (LDA)|||||3.45|-2.50|0.756
72498226|NCT00862251|144526906|SUPERIORITY_OR_OTHER_LEGACY||Least Sqares Mean Difference|-0.52||||0.675|TWO_SIDED|95.0|-2.96|1.92|||Longitudinal data analysis (LDA)|||||1.92|-2.96|0.675
72498227|NCT00862251|144526907|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-11.62|||<|0.001|TWO_SIDED|95.0|-15.93|-7.31|||Longitudinal data analysis (LDA)|||||-7.31|-15.93|<0.001
72498228|NCT00862251|144526907|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-3.18||||0.078|TWO_SIDED|95.0|-6.71|0.35|||Longitudinal data analysis (LDA)|||||0.35|-6.71|0.078
72498229|NCT00862251|144526908|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-14.16|||<|0.001|TWO_SIDED|95.0|-20.23|-8.1|||Longitudinal data analysis (LDA)|||||-8.10|-20.23|<0.001
72390419|NCT04115839|144288596|SUPERIORITY||Difference in response rates|-5.5|||||TWO_SIDED|95.0|-23.4|12.4|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||12.4|-23.4|
72498230|NCT00862251|144526908|SUPERIORITY_OR_OTHER_LEGACY||Least Sqares Mean Difference|-2.56||||0.313|TWO_SIDED|95.0|-7.53|2.41|||Longitudinal data analysis (LDA)|||||2.41|-7.53|0.313
72498231|NCT00862251|144526909|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-8.17|||<|0.001|TWO_SIDED|95.0|-12.1|-4.23|||Longitudinal data analysis (LDA)|||||-4.23|-12.10|<0.001
72390420|NCT04115839|144288596|SUPERIORITY||Difference in response rates|1.3|||||TWO_SIDED|95.0|-21.5|24.1|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 8||24.1|-21.5|
72390421|NCT04115839|144288596|SUPERIORITY||Difference in response rates|0.0|||||TWO_SIDED|95.0|-22.2|22.2|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 8||22.2|-22.2|
72390422|NCT04115839|144288596|SUPERIORITY||Difference in response rates|21.6|||||TWO_SIDED|95.0|-0.8|43.9|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 12||43.9|-0.8|
72390423|NCT04115839|144288596|SUPERIORITY||Difference in response rates|20.6|||||TWO_SIDED|95.0|-1.4|42.6|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 12||42.6|-1.4|
72390424|NCT04115839|144288596|SUPERIORITY||Difference in response rates|17.5|||||TWO_SIDED|95.0|-7.7|42.7|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||42.7|-7.7|
72390425|NCT04115839|144288596|SUPERIORITY||Difference in response rates|3.0|||||TWO_SIDED|95.0|-20.2|26.3|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||26.3|-20.2|
72390426|NCT04115839|144288599|SUPERIORITY||Difference in response rates|9.3|||||TWO_SIDED|95.0|-9.2|27.8||||||Week 2||27.8|-9.2|
72390427|NCT04115839|144288599|SUPERIORITY||Difference in response rates|3.8|||||TWO_SIDED|95.0|-13.5|21.0||||||Week 2||21.0|-13.5|
72390428|NCT04115839|144288599|SUPERIORITY||Difference in response rates|5.7|||||TWO_SIDED|95.0|-16.8|28.2||||||Week 4||28.2|-16.8|
72390429|NCT04115839|144288599|SUPERIORITY||Difference in response rates|-2.4|||||TWO_SIDED|95.0|-23.7|19.0||||||Week 4||19.0|-23.7|
72390430|NCT04115839|144288599|SUPERIORITY||Difference in response rates|5.3|||||TWO_SIDED|95.0|-21.1|31.8||||||Week 8||31.8|-21.1|
72390431|NCT04115839|144288599|SUPERIORITY||Difference in response rates|-5.9|||||TWO_SIDED|95.0|-31.0|19.3||||||Week 8||19.3|-31.0|
72390432|NCT04115839|144288599|SUPERIORITY||Difference in response rates|19.2|||||TWO_SIDED|95.0|-7.0|45.3||||||Week 12||45.3|-7.0|
72390433|NCT04115839|144288599|SUPERIORITY||Difference in response rates|8.8|||||TWO_SIDED|95.0|-16.9|34.6||||||Week 12||34.6|-16.9|
72390434|NCT04115839|144288599|SUPERIORITY||Difference in response rates|18.5|||||TWO_SIDED|95.0|-8.7|45.6||||||Week 16||45.6|-8.7|
72390435|NCT04115839|144288599|SUPERIORITY||Difference in response rates|3.0|||||TWO_SIDED|95.0|-23.4|29.5||||||Week 16||29.5|-23.4|
72390436|NCT04115839|144288601|SUPERIORITY||Difference in response rates|-2.8|||||TWO_SIDED|95.0|-11.0|5.4||||||Week 2||5.4|-11.0|
72390437|NCT04115839|144288601|SUPERIORITY||Difference in response rates|0.3|||||TWO_SIDED|95.0|-10.6|11.1||||||Week 2||11.1|-10.6|
72390438|NCT04115839|144288601|SUPERIORITY||Difference in response rates|-2.9|||||TWO_SIDED|95.0|-15.2|9.5||||||Week 4||9.5|-15.2|
72390439|NCT04115839|144288601|SUPERIORITY||Difference in response rates|-5.7|||||TWO_SIDED|95.0|-16.3|4.9||||||Week 4||4.9|-16.3|
72390440|NCT04115839|144288601|SUPERIORITY||Difference in response rates|0.6|||||TWO_SIDED|95.0|-16.4|17.5||||||Week 8||17.5|-16.4|
72390441|NCT04115839|144288601|SUPERIORITY||Difference in response rates|-5.9|||||TWO_SIDED|95.0|-19.9|8.2||||||Week 8||8.2|-19.9|
72390442|NCT04115839|144288601|SUPERIORITY||Difference in response rates|12.2|||||TWO_SIDED|95.0|-4.3|28.7||||||Week 12||28.7|-4.3|
72390443|NCT04115839|144288601|SUPERIORITY||Difference in response rates|2.9|||||TWO_SIDED|95.0|-9.7|15.6||||||Week 12||15.6|-9.7|
72447389|NCT03848065|144411991|OTHER||Difference in Percentages|95.2|||||TWO_SIDED|95.0|84.1|98.7|||||Difference=% V114-IM minus % PCV13-SC. The 95% CI is based on the Miettinen and Nurminen method.|ST 22F||98.7|84.1|
72447390|NCT03848065|144411991|OTHER||Difference in Percentages|-4.5|||||TWO_SIDED|95.0|-15.2|3.6|||||Difference=% V114-SC minus % V114-IM. The 95% CI is based on the Miettinen and Nurminen method.|ST 22F||3.6|-15.2|
72447391|NCT03848065|144411991|OTHER||Difference in Percentages|81.8|||||TWO_SIDED|95.0|67.9|90.5|||||Difference = % V114-SC minus % PCV13-SC. The 95% CI is based on the Miettinen and Nurminen method.|ST 33F||90.5|67.9|
72447392|NCT03848065|144411991|OTHER||Difference in Percentages|88.9|||||TWO_SIDED|95.0|76.4|95.2|||||Difference=% V114-IM minus % PCV13-SC. The 95% CI is based on the Miettinen and Nurminen method.|ST 33F||95.2|76.4|
72447393|NCT03848065|144411991|OTHER||Difference in Percentages|-7.1|||||TWO_SIDED|95.0|-22.7|8.2|||||Difference=% V114-SC minus % V114-IM. The 95% CI is based on the Miettinen and Nurminen method.|ST 33F||8.2|-22.7|
72447394|NCT03848065|144411992|OTHER||Geometric Mean Concentration (GMC) Ratio|0.76|||||TWO_SIDED|95.0|0.58|1.0|||||GMC Ratio=GMC V114-SC/GMC PCV13-SC. Based on an analysis of variance (ANOVA) model with natural log-transformed antibody responses as response variable and vaccination group as a single factor.|ST 1||1.00|0.58|
72447395|NCT03848065|144411992|OTHER||GMC Ratio|0.86|||||TWO_SIDED|95.0|0.65|1.13|||||GMC Ratio=GMC V114-IM/GMC PCV13-SC. Based on an ANOVA model with natural log-transformed antibody responses as response variable and vaccination group as a single factor.|||1.13|0.65|
72447396|NCT03848065|144411992|OTHER||GMC Ratio|0.89|||||TWO_SIDED|95.0|0.68|1.16|||||GMC Ratio=GMC V114-SC/GMC V114-IM. Based on an ANOVA model with natural log-transformed antibody responses as response variable and vaccination group as a single factor.|||1.16|0.68|
72447397|NCT03848065|144411992|OTHER||GMC Ratio|1.3|||||TWO_SIDED|95.0|0.96|1.76|||||GMC Ratio=GMC V114-SC/GMC PCV13-SC. Based on an ANOVA model with natural log-transformed antibody responses as response variable and vaccination group as a single factor.|ST 3||1.76|0.96|
72447398|NCT03848065|144411992|OTHER||GMC Ratio|1.49|||||TWO_SIDED|95.0|1.1|2.01|||||GMC Ratio=GMC V114-IM/GMC PCV13-SC. Based on an ANOVA model with natural log-transformed antibody responses as response variable and vaccination group as a single factor.|ST 3||2.01|1.10|
72498232|NCT00862251|144526909|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-1.83||||0.266|TWO_SIDED|95.0|-5.05|1.4|||Longitudinal data analysis (LDA)|||||1.40|-5.05|0.266
72498233|NCT00862251|144526910|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-11.45|||<|0.001|TWO_SIDED|95.0|-17.16|-5.75|||Longitudinal data analysis (LDA)|||||-5.75|-17.16|<0.001
72447399|NCT03848065|144411992|OTHER||GMC Ratio|0.88|||||TWO_SIDED|95.0|0.65|1.18|||||GMC Ratio=GMC V114-SC/GMC V114 IM. Based on an ANOVA model with natural log-transformed antibody responses as response variable and vaccination group as a single factor.|ST 3||1.18|0.65|
72447400|NCT03848065|144411992|OTHER||GMC Ratio|0.72|||||TWO_SIDED|95.0|0.58|0.9|||||GMC Ratio=GMC V114-SC/GMC PCV13-SC. Based on an ANOVA model with natural log-transformed antibody responses as response variable and vaccination group as a single factor.|ST 4||0.90|0.58|
72447401|NCT03848065|144411992|OTHER||GMC Ratio|0.81|||||TWO_SIDED|95.0|0.65|1.0|||||GMC Ratio=GMC V114-IM/GMC PCV13-SC. Based on an ANOVA model with natural log-transformed antibody responses as response variable and vaccination group as a single factor.|ST 4||1.00|0.65|
72447402|NCT03848065|144411992|OTHER||GMC Ratio|0.9|||||TWO_SIDED|95.0|0.72|1.11|||||GMC Ratio=GMC V114-SC/GMC V114 IM. Based on an ANOVA model with natural log-transformed antibody responses as response variable and vaccination group as a single factor.|ST 4||1.11|0.72|
72447403|NCT03848065|144411992|OTHER||GMC Ratio|0.84|||||TWO_SIDED|95.0|0.6|1.16|||||GMC Ratio=GMC V114-SC/GMC PCV13-SC. Based on an ANOVA model with natural log-transformed antibody responses as response variable and vaccination group as a single factor.|ST 5||1.16|0.60|
72447404|NCT03848065|144411992|OTHER||GMC Ratio|0.95|||||TWO_SIDED|95.0|0.69|1.31|||||GMC Ratio=GMC V114-IM/GMC PCV13-SC. Based on an ANOVA model with natural log-transformed antibody responses as response variable and vaccination group as a single factor.|ST 5||1.31|0.69|
72447405|NCT03848065|144411992|OTHER||GMC Ratio|0.88|||||TWO_SIDED|95.0|0.64|1.21|||||GMC Ratio=GMC V114-SC/GMC V114 IM. Based on an ANOVA model with natural log-transformed antibody responses as response variable and vaccination group as a single factor.|ST 5||1.21|0.64|
72447406|NCT03848065|144411992|OTHER||GMC Ratio|0.63|||||TWO_SIDED|95.0|0.47|0.84|||||GMC Ratio=GMC V114-SC/GMC PCV13-SC. Based on an ANOVA model with natural log-transformed antibody responses as response variable and vaccination group as a single factor.|ST 6A||0.84|0.47|
72447407|NCT03848065|144411992|OTHER||GMC Ratio|0.69|||||TWO_SIDED|95.0|0.52|0.93|||||GMC Ratio=GMC V114-IM/GMC PCV13-SC. Based on an ANOVA model with natural log-transformed antibody responses as response variable and vaccination group as a single factor.|ST 6A||0.93|0.52|
72498234|NCT00862251|144526910|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-2.13||||0.371|TWO_SIDED|95.0|-6.81|2.54|||Longitudinal data analysis (LDA)|||||2.54|-6.81|0.371
72447408|NCT03848065|144411992|OTHER||GMC Ratio|0.91|||||TWO_SIDED|95.0|0.68|1.21|||||GMC Ratio=GMC V114-SC/GMC V114 IM. Based on an ANOVA model with natural log-transformed antibody responses as response variable and vaccination group as a single factor.|ST 6A||1.21|0.68|
72447409|NCT03848065|144411992|OTHER||GMC Ratio|0.53|||||TWO_SIDED|95.0|0.36|0.79|||||GMC Ratio=GMC V114-SC/GMC PCV13-SC. Based on an ANOVA model with natural log-transformed antibody responses as response variable and vaccination group as a single factor.|ST 6B||0.79|0.36|
72447410|NCT03848065|144411992|OTHER||GMC Ratio|0.6|||||TWO_SIDED|95.0|0.41|0.9|||||GMC Ratio=GMC V114-IM/GMC PCV13-SC. Based on an ANOVA model with natural log-transformed antibody responses as response variable and vaccination group as a single factor.|ST 6B||0.90|0.41|
72447411|NCT03848065|144411992|OTHER||GMC Ratio|0.88|||||TWO_SIDED|95.0|0.59|1.3|||||GMC Ratio=GMC V114-SC/GMC V114 IM. Based on an ANOVA model with natural log-transformed antibody responses as response variable and vaccination group as a single factor.|ST 6B||1.30|0.59|
72498235|NCT00862251|144526911|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-8.01|||<|0.001|TWO_SIDED|95.0|-11.46|-4.56|||Longitudinal data analysis (LDA)|||||-4.56|-11.46|<0.001
72498236|NCT00862251|144526911|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-2.95||||0.041|TWO_SIDED|95.0|-5.78|-0.12|||Longitudinal data analysis (LDA)|||||-0.12|-5.78|0.041
72498237|NCT00862251|144526912|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|1.57||||0.218|TWO_SIDED|95.0|-0.93|4.06|||Longitudinal data analysis (LDA)|||||4.06|-0.93|0.218
72498238|NCT00862251|144526912|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.22||||0.832|TWO_SIDED|95.0|-2.27|1.83|||Longitudinal data analysis (LDA)|||||1.83|-2.27|0.832
72498239|NCT00862251|144526913|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-8.91|||<|0.001|TWO_SIDED|95.0|-13.36|-4.47|||Longitudinal data analysis (LDA)|||||-4.47|-13.36|<0.001
72561405|NCT01525628|144653431|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 66 vs. Day 9 (%)|120.67|STANDARD_DEVIATION|58.3||0.4337|TWO_SIDED|90.0|83.68|174.01|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of BI 208833 at Day 66 vs. Day 9 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 66 vs. Day 9||174.01|83.68|0.4337
72390444|NCT04115839|144288601|SUPERIORITY||Difference in response rates|13.1|||||TWO_SIDED|95.0|-4.2|30.4||||||Week 16||30.4|-4.2|
72390445|NCT04115839|144288601|SUPERIORITY||Difference in response rates|12.1|||||TWO_SIDED|95.0|-4.5|28.7||||||Week 16||28.7|-4.5|
72390446|NCT04115839|144288604|SUPERIORITY||Difference in response rates|18.5|||||TWO_SIDED|95.0|-3.8|40.7|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 2||40.7|-3.8|
72390447|NCT04115839|144288604|SUPERIORITY||Difference in response rates|7.3|||||TWO_SIDED|95.0|-13.5|28.2|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 2||28.2|-13.5|
72390448|NCT04115839|144288604|SUPERIORITY||Difference in response rates|16.0|||||TWO_SIDED|95.0|-8.5|40.4|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||40.4|-8.5|
72390449|NCT04115839|144288604|SUPERIORITY||Difference in response rates|15.5|||||TWO_SIDED|95.0|-9.4|40.3|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||40.3|-9.4|
72390450|NCT04115839|144288604|SUPERIORITY||Difference in response rates|18.8|||||TWO_SIDED|95.0|-7.5|45.0|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 8||45.0|-7.5|
72390451|NCT04115839|144288604|SUPERIORITY||Difference in response rates|-5.9|||||TWO_SIDED|95.0|-32.5|20.7|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 8||20.7|-32.5|
72390452|NCT04115839|144288604|SUPERIORITY||Difference in response rates|40.5|||||TWO_SIDED|95.0|15.8|65.2|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 12||65.2|15.8|
72390453|NCT04115839|144288604|SUPERIORITY||Difference in response rates|23.5|||||TWO_SIDED|95.0|-2.5|49.5|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 12||49.5|-2.5|
72390454|NCT04115839|144288604|SUPERIORITY||Difference in response rates|20.1|||||TWO_SIDED|95.0|-6.8|46.9|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||46.9|-6.8|
72390455|NCT04115839|144288604|SUPERIORITY||Difference in response rates|6.1|||||TWO_SIDED|95.0|-21.0|33.1|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||33.1|-21.0|
72390456|NCT04115839|144288608|SUPERIORITY||Difference in response rates|0.0|||||TWO_SIDED|95.0|-31.0|31.0|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||31.0|-31.0|
72390457|NCT04115839|144288608|SUPERIORITY||Difference in response rates|22.0|||||TWO_SIDED|95.0|-12.8|56.7|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||56.7|-12.8|
72390458|NCT04115839|144288608|SUPERIORITY||Difference in response rates|4.3|||||TWO_SIDED|95.0|-37.9|46.5|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 8||46.5|-37.9|
72390459|NCT04115839|144288608|SUPERIORITY||Difference in response rates|5.5|||||TWO_SIDED|95.0|-35.4|46.3|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 8||46.3|-35.4|
72390460|NCT04115839|144288608|SUPERIORITY||Difference in response rates|17.1|||||TWO_SIDED|95.0|-25.6|59.9|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 12||59.9|-25.6|
72390461|NCT04115839|144288608|SUPERIORITY||Difference in response rates|-13.4|||||TWO_SIDED|95.0|-53.7|26.8|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 12||26.8|-53.7|
72390462|NCT04115839|144288608|SUPERIORITY||Difference in response rates|28.6|||||TWO_SIDED|95.0|-14.1|71.2|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||71.2|-14.1|
72390463|NCT04115839|144288608|SUPERIORITY||Difference in response rates|-0.4|||||TWO_SIDED|95.0|-40.8|39.9|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||39.9|-40.8|
72390464|NCT04115839|144288610|SUPERIORITY||Difference in response rates|6.7||||0.55|TWO_SIDED|95.0|-21.3|34.7||P-value was calculated from the logistic regression with treatment groups and stratification factors (geographic region, concurrent use of csDMARD(s) and/or apremilast at randomization, prior use of bioDMARD(s)) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||34.7|-21.3|0.55
72390465|NCT04115839|144288610|SUPERIORITY||Difference in response rates|11.0||||0.24|TWO_SIDED|95.0|-17.4|39.3||P-value was calculated from the logistic regression with treatment groups and stratification factors (geographic region, concurrent use of csDMARD(s) and/or apremilast at randomization, prior use of bioDMARD(s)) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||39.3|-17.4|0.24
72390466|NCT04115839|144288610|SUPERIORITY||Difference in response rates|6.2||||0.47|TWO_SIDED|95.0|-22.6|35.0||P-value was calculated from the logistic regression with treatment groups and stratification factors (geographic region, concurrent use of csDMARD(s) and/or apremilast at randomization, prior use of bioDMARD(s)) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 8||35.0|-22.6|0.47
72447412|NCT03848065|144411992|OTHER||GMC Ratio|0.61|||||TWO_SIDED|95.0|0.46|0.81|||||GMC Ratio=GMC V114-SC/GMC PCV13-SC. Based on an ANOVA model with natural log-transformed antibody responses as response variable and vaccination group as a single factor.|ST 7F||0.81|0.46|
72447413|NCT03848065|144411992|OTHER||GMC Ratio|0.68|||||TWO_SIDED|95.0|0.52|0.9|||||GMC Ratio=GMC V114-IM/GMC PCV13-SC. Based on an ANOVA model with natural log-transformed antibody responses as response variable and vaccination group as a single factor.|ST 7F||0.90|0.52|
72447414|NCT03848065|144411992|OTHER||GMC Ratio|0.89|||||TWO_SIDED|95.0|0.67|1.17|||||GMC Ratio=GMC V114-SC/GMC V114 IM. Based on an ANOVA model with natural log-transformed antibody responses as response variable and vaccination group as a single factor.|ST 7F||1.17|0.67|
72447415|NCT03848065|144411992|OTHER||GMC Ratio|0.75|||||TWO_SIDED|95.0|0.57|0.99|||||GMC Ratio=GMC V114-SC/GMC PCV13-SC. Based on an ANOVA model with natural log-transformed antibody responses as response variable and vaccination group as a single factor.|ST 9V||0.99|0.57|
72447416|NCT03848065|144411992|OTHER||GMC Ratio|0.86|||||TWO_SIDED|95.0|0.65|1.13|||||GMC Ratio=GMC V114-IM/GMC PCV13-SC. Based on an ANOVA model with natural log-transformed antibody responses as response variable and vaccination group as a single factor.|ST 9V||1.13|0.65|
72447417|NCT03848065|144411992|OTHER||GMC Ratio|0.88|||||TWO_SIDED|95.0|0.67|1.15|||||GMC Ratio=GMC V114-SC/GMC V114 IM. Based on an ANOVA model with natural log-transformed antibody responses as response variable and vaccination group as a single factor.|ST 9V||1.15|0.67|
72447418|NCT03848065|144411992|OTHER||GMC Ratio|0.84|||||TWO_SIDED|95.0|0.6|1.19|||||GMC Ratio=GMC V114-SC/GMC PCV13-SC. Based on an ANOVA model with natural log-transformed antibody responses as response variable and vaccination group as a single factor.|ST 14||1.19|0.60|
72447419|NCT03848065|144411992|OTHER||GMC Ratio|1.02|||||TWO_SIDED|95.0|0.72|1.43|||||GMC Ratio=GMC V114-IM/GMC PCV13-SC. Based on an ANOVA model with natural log-transformed antibody responses as response variable and vaccination group as a single factor.|ST 14||1.43|0.72|
72447420|NCT03848065|144411992|OTHER||GMC Ratio|0.83|||||TWO_SIDED|95.0|0.59|1.16|||||GMC Ratio=GMC V114-SC/GMC V114 IM. Based on an ANOVA model with natural log-transformed antibody responses as response variable and vaccination group as a single factor.|ST 14||1.16|0.59|
72447421|NCT03848065|144411992|OTHER||GMC Ratio|0.69|||||TWO_SIDED|95.0|0.53|0.9|||||GMC Ratio=GMC V114-SC/GMC PCV13-SC. Based on an ANOVA model with natural log-transformed antibody responses as response variable and vaccination group as a single factor.|ST 18C||0.90|0.53|
72447422|NCT03848065|144411992|OTHER||GMC Ratio|0.71|||||TWO_SIDED|95.0|0.54|0.92|||||GMC Ratio=GMC V114-IM/GMC PCV13-SC. Based on an ANOVA model with natural log-transformed antibody responses as response variable and vaccination group as a single factor.|ST 18C||0.92|0.54|
72447423|NCT03848065|144411992|OTHER||GMC Ratio|0.98|||||TWO_SIDED|95.0|0.76|1.27|||||GMC Ratio=GMC V114-SC/GMC V114 IM. Based on an ANOVA model with natural log-transformed antibody responses as response variable and vaccination group as a single factor.|ST 18C||1.27|0.76|
72447424|NCT03848065|144411992|OTHER||GMC Ratio|0.87|||||TWO_SIDED|95.0|0.66|1.15|||||GMC Ratio=GMC V114-SC/GMC PCV13-SC. Based on an ANOVA model with natural log-transformed antibody responses as response variable and vaccination group as a single factor.|ST 19A||1.15|0.66|
72447425|NCT03848065|144411992|OTHER||GMC Ratio|0.73|||||TWO_SIDED|95.0|0.55|0.96|||||GMC Ratio=GMC V114-IM/GMC PCV13-SC. Based on an ANOVA model with natural log-transformed antibody responses as response variable and vaccination group as a single factor.|ST 19A||0.96|0.55|
72447426|NCT03848065|144411992|OTHER||GMC Ratio|1.19|||||TWO_SIDED|95.0|0.9|1.57|||||GMC Ratio=GMC V114-SC/GMC V114 IM. Based on an ANOVA model with natural log-transformed antibody responses as response variable and vaccination group as a single factor.|ST 19A||1.57|0.90|
72447427|NCT03848065|144411992|OTHER||GMC Ratio|0.71|||||TWO_SIDED|95.0|0.57|0.89|||||GMC Ratio=GMC V114-SC/GMC PCV13-SC. Based on an ANOVA model with natural log-transformed antibody responses as response variable and vaccination group as a single factor.|ST 19F||0.89|0.57|
72447428|NCT03848065|144411992|OTHER||GMC Ratio|0.77|||||TWO_SIDED|95.0|0.62|0.95|||||GMC Ratio=GMC V114-IM/GMC PCV13-SC. Based on an ANOVA model with natural log-transformed antibody responses as response variable and vaccination group as a single factor.|ST 19F||0.95|0.62|
72447429|NCT03848065|144411992|OTHER||GMC Ratio|0.93|||||TWO_SIDED|95.0|0.75|1.15|||||GMC Ratio=GMC V114-SC/GMC V114 IM. Based on an ANOVA model with natural log-transformed antibody responses as response variable and vaccination group as a single factor.|ST 19F||1.15|0.75|
72447430|NCT03848065|144411992|OTHER||GMC Ratio|0.79|||||TWO_SIDED|95.0|0.57|1.09|||||GMC Ratio=GMC V114-SC/GMC PCV13-SC. Based on an ANOVA model with natural log-transformed antibody responses as response variable and vaccination group as a single factor.|ST 23F||1.09|0.57|
72447431|NCT03848065|144411992|OTHER||GMC Ratio|0.8|||||TWO_SIDED|95.0|0.58|1.09|||||GMC Ratio=GMC V114-IM/GMC PCV13-SC. Based on an ANOVA model with natural log-transformed antibody responses as response variable and vaccination group as a single factor.|ST 23F||1.09|0.58|
72447432|NCT03848065|144411992|OTHER||GMC Ratio|0.99|||||TWO_SIDED|95.0|0.73|1.36|||||GMC Ratio=GMC V114-SC/GMC V114 IM. Based on an ANOVA model with natural log-transformed antibody responses as response variable and vaccination group as a single factor.|ST 23F||1.36|0.73|
72447433|NCT03848065|144411992|OTHER||GMC Ratio|134.88|||||TWO_SIDED|95.0|88.91|204.62|||||GMC Ratio=GMC V114-SC/GMC PCV13-SC. Based on an ANOVA model with natural log-transformed antibody responses as response variable and vaccination group as a single factor.|ST 22F||204.62|88.91|
72561406|NCT01525628|144653432|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 17 vs. Day 9 (%)|397.73|STANDARD_DEVIATION|31.6||1|TWO_SIDED|90.0|330.79|478.22|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of BI 208833 at Day 17 vs. Day 9 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 17 vs. Day 9||478.22|330.79|1.0000
72447434|NCT03848065|144411992|OTHER||GMC Ratio|204.6|||||TWO_SIDED|95.0|135.18|309.69|||||GMC Ratio=GMC V114-IM/GMC PCV13-SC. Based on an ANOVA model with natural log-transformed antibody responses as response variable and vaccination group as a single factor.|ST 22F||309.69|135.18|
72447435|NCT03848065|144411992|OTHER||GMC Ratio|0.66|||||TWO_SIDED|95.0|0.44|0.99|||||GMC Ratio=GMC V114-SC/GMC V114 IM. Based on an ANOVA model with natural log-transformed antibody responses as response variable and vaccination group as a single factor.|ST 22F||0.99|0.44|
72498240|NCT00862251|144526913|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-2.52||||0.175|TWO_SIDED|95.0|-6.17|1.13|||Longitudinal data analysis (LDA)|||||1.13|-6.17|0.175
72447436|NCT03848065|144411992|OTHER||GMC Ratio|25.11|||||TWO_SIDED|95.0|15.34|41.13|||||GMC Ratio=GMC V114-SC/GMC PCV13-SC. Based on an ANOVA model with natural log-transformed antibody responses as response variable and vaccination group as a single factor.|ST 33F||41.13|15.34|
72447437|NCT03848065|144411992|OTHER||GMC Ratio|34.18|||||TWO_SIDED|95.0|20.93|55.83|||||GMC Ratio=GMC V114-IM/GMC PCV13-SC. Based on an ANOVA model with natural log-transformed antibody responses as response variable and vaccination group as a single factor.|ST 33F||55.83|20.93|
72447438|NCT03848065|144411992|OTHER||GMC Ratio|0.73|||||TWO_SIDED|95.0|0.45|1.19|||||GMC Ratio=GMC V114-SC/GMC V114 IM. Based on an ANOVA model with natural log-transformed antibody responses as response variable and vaccination group as a single factor.|ST 33F||1.19|0.45|
72447439|NCT03848065|144411993|OTHER||Difference in Percentages|2.5|||||TWO_SIDED|95.0|-7.7|13.9|||||Difference = % V114-SC minus % PCV13-SC. The 95% CI is based on the Miettinen and Nurminen method.|Diphtheria Toxin||13.9|-7.7|
72498241|NCT00862251|144526914|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-2.78||||0.749|TWO_SIDED|95.0|-19.88|14.32|||Longitudinal data analysis (LDA)|||||14.32|-19.88|0.749
72498242|NCT00862251|144526914|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|4.69||||0.494|TWO_SIDED|95.0|-8.73|18.1|||Longitudinal data analysis (LDA)|||||18.10|-8.73|0.494
72498243|NCT00891995|144526921|SUPERIORITY_OR_OTHER|||||||0.49||||||One-sided p-value.|ANCOVA|Adjusted for baseline C-peptide AUC, age, gender and diabetic ketoacidosis.||||||0.49
72561407|NCT01525628|144653432|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 66 vs. Day 9 (%)|142.27|STANDARD_DEVIATION|53.1||0.7346|TWO_SIDED|90.0|99.49|203.44|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of BI 208833 at Day 66 vs. Day 9 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 66 vs. Day 9||203.44|99.49|0.7346
72447440|NCT03848065|144411993|OTHER||Difference in Percentages|0.3|||||TWO_SIDED|95.0|-10.8|12.0|||||Difference = % V114-IM minus % PCV13-SC. The 95% CI is based on the Miettinen and Nurminen method.|Diphtheria Toxin||12.0|-10.8|
72447441|NCT03848065|144411993|OTHER||Difference in Percentages|2.2|||||TWO_SIDED|95.0|-8.0|13.0|||||Difference = % V114-SC minus % V114-IM. The 95% CI is based on the Miettinen and Nurminen method.|Diphtheria Toxin||13.0|-8.0|
72447442|NCT03848065|144411993|OTHER||Difference in Percentages|2.4|||||TWO_SIDED|95.0|-5.8|12.4|||||Difference = % V114 SC minus % PCV13-SC. The 95% CI is based on the Miettinen and Nurminen method.|Tetanus Toxin||12.4|-5.8|
72447443|NCT03848065|144411993|OTHER||Difference in Percentages|2.4|||||TWO_SIDED|95.0|-5.7|12.4|||||Difference = % V114-IM minus % PCV13-SC. The 95% CI is based on the Miettinen and Nurminen method.|Tetanus Toxin||12.4|-5.7|
72447444|NCT03848065|144411993|OTHER||Difference in Percentages|0.0|||||TWO_SIDED|95.0|-8.1|7.9|||||Difference = % V114-SC minus % V114-IM. The 95% CI is based on the Miettinen and Nurminen method.|Tetanus Toxin||7.9|-8.1|
72447445|NCT03848065|144411993|OTHER||Difference in Percentages|0.0|||||TWO_SIDED|95.0|-8.1|8.5|||||Difference = % V114-SC minus % PCV13-SC. The 95% CI is based on the Miettinen and Nurminen method.|Pertussis Toxin||8.5|-8.1|
72447446|NCT03848065|144411993|OTHER||Difference in Percentages|0.0|||||TWO_SIDED|95.0|-7.9|8.5|||||Difference = % V114-IM minus % PCV13-SC. The 95% CI is based on the Miettinen and Nurminen method.|Pertussis Toxin||8.5|-7.9|
72498244|NCT00891995|144526924|SUPERIORITY_OR_OTHER|||||||0.4||||||One-sided p-value|ANCOVA|Adjusted for baseline A1c, age, gender and Diabetic ketoacidosis||||||0.40
72498245|NCT02054702|144526930|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Mixed Models Analysis|Mixed model repeated measures method with model terms: baseline, visit, and baseline by visit interaction.||Statistical analysis is mean change in PANSS total score from baseline to week 6 for brexpiprazole.||||<0.0001
72498246|NCT02054702|144526930|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Mixed Models Analysis|Mixed model repeated measures method with model terms: baseline, visit, and baseline by visit interaction.||Statistical analysis is mean change in PANSS total score from baseline to week 6 for aripiprazole.||||<0.0001
72498247|NCT02054702|144526931|SUPERIORITY_OR_OTHER|||||||0.4244|TWO_SIDED||||||Mixed Models Analysis|Mixed model repeated measures method with model terms: baseline, visit, and baseline by visit interaction.||Statistical analysis is mean change in cognitive test composite battery score from baseline to week 6 for brexpiprazole.||||0.4244
72447447|NCT03848065|144411993|OTHER||Difference in Percentages|0.0|||||TWO_SIDED|95.0|-8.1|7.9|||||Difference = % V114 SC minus % V114 IM. The 95% CI is based on the Miettinen and Nurminen method.|Pertussis Toxin||7.9|-8.1|
72498248|NCT02054702|144526931|SUPERIORITY_OR_OTHER|||||||0.7623|TWO_SIDED||||||Mixed Models Analysis|Mixed model repeated measures method with model terms: baseline, visit, and baseline by visit interaction.||Statistical analysis is mean change in cognitive test composite battery score from baseline to week 6 for aripiprazole.||||0.7623
72498249|NCT02054702|144526932|SUPERIORITY_OR_OTHER|||||||0.8759|TWO_SIDED||||||Mixed Models Analysis|Mixed model repeated measures method with model terms: baseline, visit, and baseline by visit interaction.||Statistical analysis is mean change in cognitive test battery of early phase battery score from baseline to week 6 for aripiprazole.||||0.8759
72447448|NCT03848065|144411993|OTHER||Difference in Percentages|0.0|||||TWO_SIDED|95.0|-8.1|8.5|||||Difference = % V114-SC minus % PCV13-SC. The 95% CI is based on the Miettinen and Nurminen method.|Pertussis FHA||8.5|-8.1|
72447449|NCT03848065|144411993|OTHER||Difference in Percentages|0.0|||||TWO_SIDED|95.0|-7.9|8.5|||||Difference = % V114-IM minus % PCV13-SC. The 95% CI is based on the Miettinen and Nurminen method.|Pertussis FHA||8.5|-7.9|
72447450|NCT03848065|144411993|OTHER||Difference in Percentages|0.0|||||TWO_SIDED|95.0|-8.1|7.9|||||Difference = % V114-SC minus % V114-IM. The 95% CI is based on the Miettinen and Nurminen method.|Pertussis FHA||7.9|-8.1|
72447451|NCT03848065|144411993|OTHER||Difference in Percentages|0.0|||||TWO_SIDED|95.0|-8.1|8.5|||||Difference = % V114-SC minus % PCV13-SC. The 95% CI is based on the Miettinen and Nurminen method.|Poliovirus Type 1||8.5|-8.1|
72447452|NCT03848065|144411993|OTHER||Difference in Percentages|0.0|||||TWO_SIDED|95.0|-7.9|8.5|||||Difference = % V114-IM minus % PCV13-SC. The 95% CI is based on the Miettinen and Nurminen method.|Poliovirus Type 1||8.5|-7.9|
72447453|NCT03848065|144411993|OTHER||Difference in Percentages|0.0|||||TWO_SIDED|95.0|-8.1|7.9|||||Difference = % V114-SC minus % V114-IM. The 95% CI is based on the Miettinen and Nurminen method.|Poliovirus Type 1||7.9|-8.1|
72447454|NCT03848065|144411993|OTHER||Difference in Percentages|0.0|||||TWO_SIDED|95.0|-8.1|8.5|||||Difference = % V114-SC minus % PCV13-SC. The 95% CI is based on the Miettinen and Nurminen method.|Poliovirus Type 2||8.5|-8.1|
72447455|NCT03848065|144411993|OTHER||Difference in Percentages|0.0|||||TWO_SIDED|95.0|-7.9|8.5|||||Difference = % V114-IM minus % PCV13-SC. The 95% CI is based on the Miettinen and Nurminen method.|Poliovirus Type 2||8.5|-7.9|
72447456|NCT03848065|144411993|OTHER||Difference in Percentages|0.0|||||TWO_SIDED|95.0|-8.1|7.9|||||Difference = % V114-SC minus % V114-IM. The 95% CI is based on the Miettinen and Nurminen method.|Poliovirus Type 2||7.9|-8.1|
72447457|NCT03848065|144411993|OTHER||Difference in Percentages|0.0|||||TWO_SIDED|95.0|-8.1|8.5|||||Difference = % V114-SC minus % PCV13-SC. The 95% CI is based on the Miettinen and Nurminen method.|Poliovirus Type 3||8.5|-8.1|
72447458|NCT03848065|144411993|OTHER||Difference in Percentages|0.0|||||TWO_SIDED|95.0|-7.9|8.5|||||"Difference = % V114-IM minus % PCV13~-SC. The 95% CI is based on the Miettinen and Nurminen method."|Poliovirus Type 3||8.5|-7.9|
72447459|NCT03848065|144411993|OTHER||Difference in Percentages|0.0|||||TWO_SIDED|95.0|-8.1|7.9|||||Difference = % V114-SC minus % V114-IM. The 95% CI is based on the Miettinen and Nurminen method.|Poliovirus Type 3||7.9|-8.1|
72447460|NCT04137367|144412027|OTHER|||||||0.05|||||||Mixed Models Analysis|||We estimated a priori that a total of 100 participants would be needed to detect a difference between ABM and sham condition, with a two-tailed α of 0.05 and (1-β) of .80. Power calculation was based on the assumption that 50 % of the participants allocated to ABM would report a minimum of 3 points reduction on BDI-II at six months, compared to 20 % in the sham condition. Assuming 15 % lost to follow up, power calculation indicated the need for 50 participants in each condition||||.05
72447461|NCT04204265|144412161|OTHER||||||<|0.0001||||||P-Value was calculated|t-test, 1 sided|||||||<0.0001
72447462|NCT04204265|144412162|OTHER||||||<|0.0001||||||P-Value was calculated|t-test, 1 sided|||||||<0.0001
72447463|NCT04204265|144412163|OTHER||||||<|0.0001||||||P-Value was calculated|t-test, 1 sided|||||||<0.0001
72561408|NCT01525628|144653433|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 17 vs. Day 9 (%)|403.86|STANDARD_DEVIATION|33.6||1|TWO_SIDED|90.0|332.19|490.99|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of BI 208833 at Day 17 vs. Day 9 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 17 vs. Day 9||490.99|332.19|1.0000
72561409|NCT01525628|144653433|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 66 vs. Day 9 (%)|116.96|STANDARD_DEVIATION|73.1||0.3968|TWO_SIDED|90.0|75.38|181.47|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of BI 208833 at Day 66 vs. Day 9 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 66 vs. Day 9||181.47|75.38|0.3968
72447464|NCT03931174|144412180|SUPERIORITY|Unit of analysis is the provider level. All 186 providers (95 ATTC, 91 E-ATTC) who enrolled in the study are included in the analysis.|Odds Ratio (OR)|2.41|STANDARD_ERROR_OF_MEAN|0.53||0.097|TWO_SIDED|95.0|0.85|6.81||CM Exposure is reported as the estimated proportion of providers delivering 10 or more CM sessions to at least one patient in a mixed model accounting for nesting.|Mixed Models Analysis|||These analyses are unadjusted. The primary outcomes paper will report both unadjusted and adjusted analyses.||6.81|0.85|0.097
72447465|NCT03931174|144412181|SUPERIORITY|Unit of analysis is the provider level. All 186 providers (95 ATTC, 91 E-ATTC) who enrolled in the study are included in the analysis.|Mean Difference (Final Values)|0.71|STANDARD_ERROR_OF_MEAN|0.31||0.02|TWO_SIDED|95.0|0.11|1.32|||t-test, 2 sided|T-test adjusted for inequality of variances||These analyses are unadjusted. The primary outcomes paper will report both unadjusted and adjusted analyses.||1.32|0.11|0.02
72447466|NCT03931174|144412182|SUPERIORITY|Unit of analysis is the organization-level. Total number of organizations included in the analysis is 28 (14 ATTC, 14 E-ATTC).|Chi-square test statistic value|0.662||||0.43|TWO_SIDED||||||Chi-squared|Pearson Chi-Square||These analyses are unadjusted.||||0.430
72619379|NCT00098293|144769622|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.88||||0.4485|TWO_SIDED|95.0|0.64|1.22|||Regression, Logistic|||Less than 400 copies/mL: Two-sided 95% CI was presented for the odds ratio between treatment groups. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (\<100,000 or \>=100,000), geographic region (Northern or Southern Hemisphere) as covariates was used. Odds ratio \> 1 would favor maraviroc.||1.22|0.64|0.4485
72619380|NCT00098293|144769622|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.84||||0.2724|TWO_SIDED|95.0|0.61|1.15|||Regression, Logistic|||Less than 50 copies/mL: Two-sided 95% CI was presented for the odds ratio between treatment groups. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (\<100,000 or \>=100,000), geographic region (Northern or Southern Hemisphere) as covariates were used. Odds ratio \> 1 would favor maraviroc.||1.15|0.61|0.2724
72447467|NCT03931174|144412183|SUPERIORITY|Analyses are at the patient-level. All patients who enrolled in the study are included in the analysis.|Mean Difference (Final Values)|-0.695|STANDARD_ERROR_OF_MEAN|0.313||0.034|TWO_SIDED|95.0|-1.3|-0.08|||Mixed Models Analysis|||These analyses are unadjusted. The primary outcomes paper will report both unadjusted and adjusted analyses.||-0.08|-1.30|.034
72498250|NCT02054702|144526932|SUPERIORITY_OR_OTHER|||||||0.2176|TWO_SIDED||||||Mixed Models Analysis|Mixed model repeated measures method with model terms: baseline, visit, and baseline by visit interaction.||Statistical analysis is mean change in cognitive test battery of early phase battery score from baseline to week 6 for aripiprazole.||||0.2176
72498251|NCT02054702|144526933|SUPERIORITY_OR_OTHER|||||||0.842|TWO_SIDED||||||Mixed Models Analysis|Mixed model repeated measures method with model terms: baseline, visit, and baseline by visit interaction.||Statistical analysis is mean change in cognitive test battery score of GML from baseline to week 6 for brexpiprazole.||||0.8420
72447468|NCT03931174|144412184|SUPERIORITY|Analyses are at the patient-level. All patients who enrolled in the study are included in the analysis.|Mean Difference (Final Values)|-0.202|STANDARD_ERROR_OF_MEAN|0.314||0.27|TWO_SIDED|95.0|-0.82|0.41|||Mixed Models Analysis|||These analyses are unadjusted. The primary outcomes paper will report both unadjusted and adjusted analyses.||0.41|-0.82|0.27
72447469|NCT03931174|144412185|SUPERIORITY|Analyses are at the provider-level. Only those providers who completed the post-implementation survey (at the end of the 9-month implementation phase) were included in the analysis.|Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|0.191||0.011|TWO_SIDED|95.0|-0.88|0.12||Means were compared between conditions in an independent-samples T-test.|t-test, 2 sided|T-test adjusted for inequality of variances||These analyses are unadjusted. The primary outcomes paper will report both unadjusted and adjusted analyses.||0.12|-0.88|.011
72447470|NCT03931174|144412186|SUPERIORITY|Analyses are at the provider-level. Only those providers who completed the post-implementation survey (at the end of the 9-month implementation phase) were included in the analysis.|Mean Difference (Final Values)|-0.29|STANDARD_ERROR_OF_MEAN|0.232||0.218|TWO_SIDED|95.0|-0.75|0.17||Means of leadership engagement scores were compared between conditions in an independent-samples T-test.|t-test, 2 sided|||These analyses are unadjusted. The primary outcomes paper will report both unadjusted and adjusted analyses.||0.17|-0.75|.218
72447471|NCT03852472|144412207|OTHER||% Difference (Avacopan - Placebo)|-8.4||||0.1321|TWO_SIDED|95.0|-18.7|2.4||P-values are obtained from a CMH test stratified by stratification factors Hurley Stage (Stage II vs III), and anti-TNF drug use (Treatment naive vs Previous treatment).|Cochran-Mantel-Haenszel|||||2.4|-18.7|0.1321
72498252|NCT02054702|144526933|SUPERIORITY_OR_OTHER|||||||0.3781|TWO_SIDED||||||Mixed Models Analysis|Mixed model repeated measures method with model terms: baseline, visit, and baseline by visit interaction.||Statistical analysis is mean change in cognitive test battery score of GML from baseline to week 6 for aripiprazole.||||0.3781
72447472|NCT03852472|144412207|OTHER||% Difference (Avacopan - Placebo)|4.3||||0.4503|TWO_SIDED|95.0|-6.9|15.5||P-values are obtained from a CMH test stratified by stratification factors Hurley Stage (Stage II vs III), and anti-TNF drug use (Treatment naive vs Previous treatment)|Cochran-Mantel-Haenszel|||||15.5|-6.9|0.4503
72498253|NCT02054702|144526934|SUPERIORITY_OR_OTHER|||||||0.1807|TWO_SIDED||||||Mixed Models Analysis|Mixed model repeated measures method with model terms: baseline, visit, and baseline by visit interaction.||Statistical analysis is mean change in cognitive test battery score of detection task from baseline to week 6 for brexpiprazole.||||0.1807
72498254|NCT02054702|144526934|SUPERIORITY_OR_OTHER|||||||0.2802|TWO_SIDED||||||Mixed Models Analysis|Mixed model repeated measures method with model terms: baseline, visit, and baseline by visit interaction.||Statistical analysis is mean change in cognitive test battery score of detection task from baseline to week 6 for aripiprazole.||||0.2802
72498255|NCT02054702|144526935|SUPERIORITY_OR_OTHER|||||||0.8622|TWO_SIDED||||||Mixed Models Analysis|Mixed model repeated measures method with model terms: baseline, visit, and baseline by visit interaction.||Statistical analysis is mean change in cognitive test battery score of identification task from baseline to week 6 for brexpiprazole.||||0.8622
72498256|NCT02054702|144526935|SUPERIORITY_OR_OTHER|||||||0.4848|TWO_SIDED||||||Mixed Models Analysis|Mixed model repeated measures method with model terms: baseline, visit, and baseline by visit interaction.||Statistical analysis is mean change in cognitive test battery score of identification task from baseline to week 6 for aripiprazole.||||0.4848
72498257|NCT02054702|144526936|SUPERIORITY_OR_OTHER|||||||0.8588|TWO_SIDED||||||Mixed Models Analysis|Mixed model repeated measures method with model terms: baseline, visit, and baseline by visit interaction.||Statistical analysis is mean change in cognitive test battery score of one card learning task from baseline to week 6 for brexpiprazole.||||0.8588
72619381|NCT00098293|144769623|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.88||||0.3943|TWO_SIDED|95.0|0.65|1.19|||Regression, Logistic|||Less than 400 copies/mL: Two-sided 95% CI was presented for the odds ratio between treatment groups. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (\<100,000 or \>=100,000), geographic region (Northern or Southern Hemisphere) as covariates were used. Odds ratio \> 1 would favor maraviroc.||1.19|0.65|0.3943
72447473|NCT03852472|144412208|OTHER||Least Squares Mean|0.6|STANDARD_ERROR_OF_MEAN|1.17||0.5784|TWO_SIDED|95.0|-1.7|2.9|||Mixed model for repeated measures|||||2.9|-1.7|0.5784
72447474|NCT03852472|144412208|OTHER||Least Squares Mean|-1.4|STANDARD_ERROR_OF_MEAN|1.17||0.2253|TWO_SIDED|95.0|-3.7|0.9|||Mixed effects model for repeated measure|||||0.9|-3.7|0.2253
72447475|NCT03161028|144412261|SUPERIORITY|||||||0.51||||||The threshold for statistical significance was p = 0.05.|Mixed Models Analysis|||For the model evaluating the primary outcome (change in T25FW), T25FW was transformed to walking speed by dividing 25 feet by the completion time in seconds (ft/sec). Any participants who were unable to complete the T25FW at any timepoint after baseline were assigned a value of 199 seconds, a statistical technique known as Winsorizing.||||0.51
72447476|NCT03161028|144412262|SUPERIORITY|||||||0.902|||||||Mixed Models Analysis|||||||0.902
72447477|NCT03161028|144412263|SUPERIORITY|||||||0.9|||||||Mixed Models Analysis|||||||0.90
72447478|NCT03161028|144412264|SUPERIORITY|||||||0.084|||||||Mixed Models Analysis|||||||0.084
72447479|NCT03161028|144412265|SUPERIORITY|||||||0.134|||||||Chi-squared|||||||0.134
72447480|NCT03492216|144412266|SUPERIORITY||Risk Difference (RD)|7.6||||0.0025|TWO_SIDED|95.0|2.7|12.5|||Regression, Logistic||adjusted risk difference for non-hazardous alcohol use, alcohol incentive groups compared to no alcohol incentive groups. logistic regression model adjusted for INH incentive arm, participant sex, and study site.|||12.5|2.7|0.0025
72447481|NCT03492216|144412267|SUPERIORITY||Risk Difference (RD)|-0.2||||0.9435|TWO_SIDED|95.0|-7.0|6.5|||Regression, Logistic||adjusted risk difference for \>90% INH adherence, INH incentive group compared to no INH incentives. logistic regression model adjusted for alcohol incentive arm, participant sex and study site.|||6.5|-7.0|0.9435
72498258|NCT02054702|144526936|SUPERIORITY_OR_OTHER|||||||0.9928|TWO_SIDED||||||Mixed Models Analysis|Mixed model repeated measures method with model terms: baseline, visit, and baseline by visit interaction.||Statistical analysis is mean change in cognitive test battery score of one card learning task from baseline to week 6 for aripiprazole.||||0.9928
72498259|NCT02054702|144526937|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Mixed Models Analysis|Mixed model repeated measures method with model terms: baseline, visit, and baseline by visit interaction.||Statistical analysis is mean change in CGI-S from baseline to week 6 for brexpiprazole.||||<0.0001
72619382|NCT00098293|144769623|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.79||||0.1289|TWO_SIDED|95.0|0.59|1.07|||Regression, Logistic|||Less than 50 copies/mL: Two-sided 95% CI was presented for the odds ratio between treatment groups. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (\<100,000 or \>=100,000), geographic region (Northern or Southern Hemisphere) as covariates were used. Odds ratio \> 1 would favor maraviroc.||1.07|0.59|0.1289
72619383|NCT00098293|144769624|SUPERIORITY_OR_OTHER||LS Mean Difference|0.118|STANDARD_ERROR_OF_MEAN|0.1077||0.2741|TWO_SIDED|95.0|-0.094|0.329|||ANCOVA|||Change at week 48: P-value was calculated using Analysis of Covariance (ANCOVA) with the model including treatment arm and, as covariates, the randomization strata (screening viral load and geographic region). The difference between the treatment least squares means (LS means) adjusted for the covariates was presented in addition to 2-sided 95% CI. Negative value would favor maraviroc.||0.329|-0.094|0.2741
72619384|NCT00098293|144769624|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.1162||0.3899|TWO_SIDED|95.0|-0.128|0.328|||ANCOVA|||Change at week 96: P-value was calculated using ANCOVA with the model including treatment arm and, as covariates, the randomization strata (screening viral load and geographic region). The difference between the treatment LS means adjusted for the covariates was presented in addition to 2-sided 95% CI. Negative value would favor maraviroc.||0.328|-0.128|0.3899
72447482|NCT03492216|144412270|SUPERIORITY||Risk Difference (RD)|-2.5||||0.26|TWO_SIDED|95.0|-6.8|1.9|||Regression, Logistic||adjusted risk different for HIV viral suppression at 12 months, Arm 2 (escalating incentives; EtG tests) compared to Arm 1 (control); logistic regression model adjusted for randomization arm, participant sex, and study site.|||1.9|-6.8|0.26
72447483|NCT03492216|144412270|SUPERIORITY||Risk Difference (RD)|0.7||||0.7|TWO_SIDED|95.0|-2.8|4.1|||Regression, Logistic||adjusted risk different for HIV viral suppression at 12 months, Arm 3 (escalating incentives; IsoScreen tests) compared to Arm 1 (control); logistic regression model adjusted for randomization arm, participant sex, and study site.|||4.1|-2.8|0.70
72447484|NCT03492216|144412270|SUPERIORITY||Risk Difference (RD)|1.3||||0.42|TWO_SIDED|95.0|-1.9|4.5|||Regression, Logistic||adjusted risk different for HIV viral suppression at 12 months, Arm 4 (escalating incentives; EtG and IsoScreen tests) compared to Arm 1 (control); logistic regression model adjusted for randomization arm, participant sex, and study site.|||4.5|-1.9|0.42
72447485|NCT03945292|144412322|SUPERIORITY||Difference|-66.81|STANDARD_ERROR_OF_MEAN|5.107|<|0.0001|TWO_SIDED|95.0|-77.18|-56.45||From a mixed model with repeated measures, including fixed effects for treatment, week, treatment-by-week interaction, presence of metabolic syndrome, presence of NAFLD or NASH, baseline serum Z-AAT as covariate, and subject as a random effect.|Mixed model repeated measures (MMRM)|NAFLD=non-alcoholic fatty liver disease; NSH=non-alcoholic steatohepatitis||||-56.45|-77.18|< 0.0001
72447486|NCT03945292|144412322|SUPERIORITY||Difference|-90.03|STANDARD_ERROR_OF_MEAN|5.26|<|0.0001|TWO_SIDED|95.0|-100.72|-79.34||From a mixed model with repeated measures, including fixed effects for treatment, week, treatment-by-week interaction, presence of metabolic syndrome, presence of NAFLD or NASH, baseline serum Z-AAT as covariate, and subject as a random effect.|MMRM|||||-79.34|-100.72|< 0.0001
72447487|NCT03945292|144412322|SUPERIORITY||Difference|-97.57|STANDARD_ERROR_OF_MEAN|5.24|<|0.0001|TWO_SIDED|95.0|-108.21|-86.94||From a mixed model with repeated measures, including fixed effects for treatment, week, treatment-by-week interaction, presence of metabolic syndrome, presence of NAFLD or NASH, baseline serum Z-AAT as covariate, and subject as a random effect.|MMRM|||||-86.94|-108.21|< 0.0001
72447488|NCT03945292|144412326|SUPERIORITY||Least Squares (LS) Mean Difference|-129.31|STANDARD_ERROR_OF_MEAN|36.409||0.0021|TWO_SIDED|95.0|-205.52|-53.11||Model based summary statistics are from an analysis of covariance (ANCOVA) model with fixed effect factors treatment group and baseline total liver Z-AAT protein as a covariate.|ANCOVA|||||-53.11|-205.52|0.0021
72447489|NCT03945292|144412326|SUPERIORITY||LS Mean Difference|-124.03|STANDARD_ERROR_OF_MEAN|37.207||0.0035|TWO_SIDED|95.0|-201.9|-46.15||Model based summary statistics are from an analysis of covariance (ANCOVA) model with fixed effect factors treatment group and baseline total liver Z-AAT protein as a covariate.|ANCOVA|||||-46.15|-201.9|0.0035
72447490|NCT03945292|144412326|SUPERIORITY||LS Mean Difference|-140.58|STANDARD_ERROR_OF_MEAN|30.906||0.0002|TWO_SIDED|95.0|-205.27|-75.89||Model based summary statistics are from an analysis of covariance (ANCOVA) model with fixed effect factors treatment group and baseline total liver Z-AAT protein as a covariate.|ANCOVA|||||-75.89|-205.27|0.0002
72447491|NCT03945292|144412328|SUPERIORITY||LS Mean Difference|-98.07|STANDARD_ERROR_OF_MEAN|20.291||0.0001|TWO_SIDED|95.0|-140.53|-55.6||Model based summary statistics are from an analysis of covariance (ANCOVA) model with fixed effect factors treatment group and baseline soluble liver Z-AAT protein as a covariate.|ANCOVA|||||-55.6|-140.53|0.0001
72447492|NCT03945292|144412328|SUPERIORITY||LS Mean Difference|-109.56|STANDARD_ERROR_OF_MEAN|21.616|<|0.0001|TWO_SIDED|95.0|-154.81|-64.32||Model based summary statistics are from an analysis of covariance (ANCOVA) model with fixed effect factors treatment group and baseline soluble liver Z-AAT protein as a covariate.|ANCOVA|||||-64.32|-154.81|< 0.0001
72447493|NCT03945292|144412328|SUPERIORITY||LS Mean Difference|-118.04|STANDARD_ERROR_OF_MEAN|17.16|<|0.0001|TWO_SIDED|95.0|-153.95|-82.12||Model based summary statistics are from an analysis of covariance (ANCOVA) model with fixed effect factors treatment group and baseline soluble liver Z-AAT protein as a covariate.|ANCOVA|||||-82.12|-153.95|< 0.0001
72447494|NCT03945292|144412330|SUPERIORITY||LS Mean Difference|-180.7|STANDARD_ERROR_OF_MEAN|74.087||0.0247|TWO_SIDED|95.0|-335.77|-25.64||Model based summary statistics are from an analysis of covariance (ANCOVA) model with fixed effect factors treatment group and baseline insoluble liver Z-AAT protein as a covariate.|ANCOVA|||||-25.64|-335.77|0.0247
72447495|NCT03945292|144412330|SUPERIORITY||LS Mean Difference|-163.79|STANDARD_ERROR_OF_MEAN|73.513||0.0382|TWO_SIDED|95.0|-317.65|-9.93||Model based summary statistics are from an analysis of covariance (ANCOVA) model with fixed effect factors treatment group and baseline insoluble liver Z-AAT protein as a covariate.|ANCOVA|||||-9.93|-317.65|0.0382
72447496|NCT03945292|144412330|SUPERIORITY||LS Mean Difference|-193.2|STANDARD_ERROR_OF_MEAN|63.089||0.0064|TWO_SIDED|95.0|-325.25|-61.15||Model based summary statistics are from an analysis of covariance (ANCOVA) model with fixed effect factors treatment group and baseline insoluble liver Z-AAT protein as a covariate.|ANCOVA|||||-61.15|-325.25|0.0064
72447497|NCT01824875|144412385|SUPERIORITY||Hazard Ratio (HR)|0.71|||||TWO_SIDED|95.0|0.46|1.07|||||Hazard ratio of Arm B/Arm A|||1.07|0.46|
72619385|NCT00098293|144769625|SUPERIORITY_OR_OTHER||LS Mean Difference|0.111|STANDARD_ERROR_OF_MEAN|0.1002||0.2693|TWO_SIDED|95.0|-0.086|0.307|||ANCOVA|||Week 48: P-value was calculated using ANCOVA with the model including treatment arm and, as covariates, the randomization strata (screening viral load and geographic region). The difference between the treatment LS means adjusted for the covariates was presented in addition to 2-sided 95% CI. Negative value would favor maraviroc.||0.307|-0.086|0.2693
72619386|NCT00098293|144769625|SUPERIORITY_OR_OTHER||LS Mean Difference|0.089|STANDARD_ERROR_OF_MEAN|0.1121||0.427|TWO_SIDED|95.0|-0.131|0.309|||ANCOVA|||Week 96: P-value was calculated using ANCOVA with the model including treatment arm and, as covariates, the randomization strata (screening viral load and geographic region). The difference between the treatment LS means adjusted for the covariates was presented in addition to 2-sided 95% CI. Negative value would favor maraviroc.||0.309|-0.131|0.4270
72619387|NCT00098293|144769626|SUPERIORITY_OR_OTHER||LS Mean Difference|26.34|STANDARD_ERROR_OF_MEAN|9.827||0.0075|TWO_SIDED|95.0|7.04|45.63|||ANCOVA|||Change at Week 48: P-value was calculated using ANCOVA with the model including treatment arm and, as covariates, baseline CD4 count and the randomization strata (screening viral load and geographic region). The difference between the treatment LS means adjusted for the covariates was presented in addition to 2-sided 95% CI. Positive value would favor maraviroc.||45.63|7.04|0.0075
72619388|NCT00098293|144769626|SUPERIORITY_OR_OTHER||LS Mean Difference|35.44|STANDARD_ERROR_OF_MEAN|11.419||0.002|TWO_SIDED|95.0|13.02|57.86|||ANCOVA|||Change at Week 96: P-value was calculated using ANCOVA with the model including treatment arm and, as covariates, baseline CD4 count and the randomization strata (screening viral load and geographic region). The difference between the treatment LS means adjusted for the covariates was presented in addition to 2-sided 95% CI. Positive value would favor maraviroc.||57.86|13.02|0.0020
72619389|NCT00098293|144769627|SUPERIORITY_OR_OTHER||LS Mean Difference|166.29|STANDARD_ERROR_OF_MEAN|25.04|<|0.0001|TWO_SIDED|95.0|117.13|215.46|||ANCOVA|||Change at Week 48: P-value was calculated using ANCOVA with the model including treatment arm and, as covariates, baseline CD8 count and the randomization strata (screening viral load and geographic region). The difference between the treatment LS means adjusted for the covariates was presented in addition to 2-sided 95% CI. Positive value would favor maraviroc.||215.46|117.13|<0.0001
72619390|NCT00098293|144769627|SUPERIORITY_OR_OTHER||LS Mean Difference|172.22|STANDARD_ERROR_OF_MEAN|25.471|<|0.0001|TWO_SIDED|95.0|122.21|222.23|||ANCOVA|||Change at Week 96: P-value was calculated using ANCOVA with the model including treatment arm and, as covariates, baseline CD8 count and the randomization strata (screening viral load and geographic region). The difference between the treatment LS means adjusted for the covariates was presented in addition to 2-sided 95% CI. Positive value would favor maraviroc.||222.23|122.21|<0.0001
72619391|NCT00098293|144769628|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.1||||0.5874|TWO_SIDED|95.0|0.83|1.45|||Log Rank|||Week 48: P-value was calculated using Log rank test controlling for the effect of the randomization strata. Hazard ratio was calculated by fitting a Cox proportional hazards model including treatment group and the two randomization strata, HIV-1 RNA at screening and geographic region. Hazard ratio \< 1 would favor maraviroc.||1.45|0.83|0.5874
72390467|NCT04115839|144288610|SUPERIORITY||Difference in response rates|10.5||||0.25|TWO_SIDED|95.0|-18.6|39.6||P-value was calculated from the logistic regression with treatment groups and stratification factors (geographic region, concurrent use of csDMARD(s) and/or apremilast at randomization, prior use of bioDMARD(s)) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 8||39.6|-18.6|0.25
72390468|NCT04115839|144288610|SUPERIORITY||Difference in response rates|18.6||||0.44|TWO_SIDED|95.0|-21.1|58.3||P-value was calculated from the logistic regression with treatment groups and stratification factors (geographic region, concurrent use of csDMARD(s) and/or apremilast at randomization, prior use of bioDMARD(s)) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 12||58.3|-21.1|0.44
72619392|NCT00098293|144769628|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.1||||0.4811|TWO_SIDED|95.0|0.86|1.4|||Log Rank|||Week 96: P-value was calculated using Log rank test controlling for the effect of the randomization strata. Hazard ratio was calculated by fitting a Cox proportional hazards model including treatment group and the two randomization strata, HIV-1 RNA at screening and geographic region. Hazard ratio \< 1 would favor maraviroc.||1.40|0.86|0.4811
72619393|NCT00098293|144769635|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was to be concluded if the lower bound of the 1-sided 97.5% CI was greater than (\>) -10%.|Difference in Percentage|-3.2|||||ONE_SIDED|97.5|-10.2|||||||Less than 400 copies/mL: Treatment difference in percentage stratified by randomization strata was presented along with the lower bound of the 1-sided 97.5% CI based on the normal approximation to the binomial distribution. Positive value would favor maraviroc. Step down procedure used to control for multiple comparisons.|||-10.2|
72619394|NCT00098293|144769635|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was to be concluded if the lower bound of the 1-sided 97.5% CI was \> -10%.|Difference in Percentage|-5.8|||||ONE_SIDED|97.5|-12.8|||||||Less than 50 copies/mL: Treatment difference in percentage stratified by randomization strata was presented along with the lower bound of the 1-sided 97.5% CI based on the normal approximation to the binomial distribution. Positive value would favor maraviroc. Step down procedure used to control for multiple comparisons.|||-12.8|
72390469|NCT04115839|144288610|SUPERIORITY||Difference in response rates|-3.8||||0.68|TWO_SIDED|95.0|-38.4|30.8||P-value was calculated from the logistic regression with treatment groups and stratification factors (geographic region, concurrent use of csDMARD(s) and/or apremilast at randomization, prior use of bioDMARD(s)) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 12||30.8|-38.4|0.68
72390470|NCT04115839|144288610|SUPERIORITY||Difference in response rates|21.4||||0.33|TWO_SIDED|95.0|-19.4|62.2||P-value was calculated from the logistic regression with treatment groups and stratification factors (geographic region, concurrent use of csDMARD(s) and/or apremilast at randomization, prior use of bioDMARD(s)) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||62.2|-19.4|0.33
72390471|NCT04115839|144288610|SUPERIORITY||Difference in response rates|2.1||||0.98|TWO_SIDED|95.0|-33.9|38.1||P-value was calculated from the logistic regression with treatment groups and stratification factors (geographic region, concurrent use of csDMARD(s) and/or apremilast at randomization, prior use of bioDMARD(s)) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||38.1|-33.9|0.98
72447498|NCT01824875|144412386|SUPERIORITY|||||||0.59|||||||Fisher Exact|||||||0.59
72447499|NCT01098812|144412392|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|43.0|STANDARD_DEVIATION|75.0|<|0.0001|ONE_SIDED|90.0|25.0|||Primary study endpoint; therefore, no adjustment for multiple comparisons. The planned alpha level for testing was 0.025.|t-test, 1 sided|||Toric IOL results for mean percent reduction in cyl compared to control results at 6 months. Null hypothesis = mean reduction for toric eyes is \<= to that of control eyes; alternate hypothesis = mean reduction for toric eyes is \> the control. There is 80% power to detect \>=31% difference in mean percent reduction in cylinder (postoperative refractive cylinder minus preoperative keratometric cylinder)/(target refractive cylinder minus preoperative keratometric cylinder) between IOL groups.|||25|<0.0001
72447500|NCT01098812|144412393|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.07|STANDARD_DEVIATION|0.15||0.0009|ONE_SIDED|90.0||-0.03||P-value compared to alpha level adjusted for multiplicity of 0.0125.|t-test, 1 sided|||Used LogMAR values for visual acuity; The null hypothesis is that the mean UCDVA for toric eyes is worse than or equal to that for control eyes; the alternate hypothesis is that the mean UCDVA for toric eyes is better than that for control eyes. There is 80% power to detect \>=0.06 LogMAR difference in mean UCDVA between IOL groups.||-0.03||0.0009
72447501|NCT05020249|144412461|SUPERIORITY||||||<|0.001||||||P-values for the comparison of treatment groups are based on the Fisher's exact test.|Fisher Exact|||||||<0.001
72447502|NCT05020249|144412462|SUPERIORITY||||||<|0.001||||||P-values for the comparison of treatment groups are based on the Fisher's exact test.|Fisher Exact|||||||<0.001
72447503|NCT05020249|144412463|SUPERIORITY|||||||0.08||||||P-values for the comparison of treatment groups are based on the Fisher's exact test.|Fisher Exact|||||||0.080
72447504|NCT05020249|144412464|SUPERIORITY|||||||0.08||||||P-values for the comparison of treatment groups are based on the Fisher's exact test.|Fisher Exact|||||||0.080
72447505|NCT05020249|144412465|SUPERIORITY||||||<|0.001||||||P-values for the comparison of treatment groups are based on the Fisher's exact test.|Fisher Exact|||||||<0.001
72447506|NCT05020249|144412466|SUPERIORITY||||||<|0.001||||||P-values for the comparison of treatment groups are based on the Fisher's exact test.|Fisher Exact|||||||<0.001
72447507|NCT05020249|144412467|SUPERIORITY||||||<|0.001||||||P-values for the comparison of treatment groups are based on the Fisher's exact test.|Fisher Exact|||||||<0.001
72447508|NCT05020249|144412468|SUPERIORITY||||||<|0.001||||||P-values for the comparison of treatment groups are based on the Fisher's exact test.|Fisher Exact|||||||<0.001
72447509|NCT05020249|144412469|SUPERIORITY||Odds Ratio (OR)|81.25|||<|0.001|TWO_SIDED|95.0|8.216|803.544||P-values for the comparison of treatment groups are based on the CMH test from the general association.|Cochran-Mantel-Haenszel|||Odds ratio of scalp IGA response for bimekizumab group compared with placebo group using CMH.||803.544|8.216|<0.001
72498260|NCT02054702|144526937|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Mixed Models Analysis|Mixed model repeated measures method with model terms: baseline, visit, and baseline by visit interaction.||Statistical analysis is mean change in CGI-S from baseline to week 6 were observed for aripiprazole.||||<0.0001
72498261|NCT02054702|144526940|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|The analysis of covariance (ANCOVA) model with treatment group and total score at baseline as covariate was used for change from baseline comparisons.||Statistical analysis is mean change in SLOF total score from baseline to week 6 for brexpiprazole.||||<0.0001
72447510|NCT05020249|144412470|SUPERIORITY||Odds Ratio (OR)|12.353||||0.007|TWO_SIDED|95.0|1.447|105.443||P-values for the comparison of treatment groups are based on the CMH test from the general association.|Cochran-Mantel-Haenszel|||Odds ratio of DLQI total score response for bimekizumab group compared with placebo group using CMH.||105.443|1.447|0.007
72447511|NCT05020249|144412471|SUPERIORITY||LS Mean Difference|-80.444|||<|0.001|TWO_SIDED|95.0|-102.509|-58.379|||ANCOVA|||||-58.379|-102.509|<0.001
72498262|NCT02054702|144526940|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Mixed Models Analysis|The ANCOVA model, with treatment group as main effect and total score at baseline as covariate, was used for change from baseline comparisons.||Statistical analysis is mean change in SLOF total score from baseline to week 6 for aripiprazole.||||<0.0001
72498263|NCT02054702|144526941|SUPERIORITY_OR_OTHER|||||||0.0392|TWO_SIDED||||||ANCOVA|The ANCOVA model, with treatment group as main effect and total score at baseline as covariate, was used for change from baseline comparisons.||Statistical analysis is mean change in BIS-11 item total score from baseline to week 6 for brexpiprazole.||||0.0392
72447512|NCT03959696|144412485|SUPERIORITY||Mean Difference (Net)|0.36||||0.011|TWO_SIDED|95.0|0.08|0.64||A priori threshold for statistical significance is .05|Regression, Linear|We used a linear regression model with Generalized Estimating Equations (GEE) techniques to account for the patients-within-physicians data structure|Mean difference is the Training + Notification arm minus the Notification only arm|The null hypothesis SDMP is equal in the two arms||.64|.08|.011
72447513|NCT03959696|144412486|SUPERIORITY||Mean Difference (Net)|1.77||||0.36|TWO_SIDED|95.0|-2.01|5.55||A priori threshold for statistical significance is .05|Regression, Linear|We used a linear regression model with Generalized Estimating Equations (GEE) techniques to account for the patients-within-physicians data structure||The null hypothesis is that the two arms have the same knowledge score||5.55|-2.01|0.36
72447514|NCT03959696|144412487|SUPERIORITY|We will have 81% power to detect a difference of 14% in rates (e.g. decrease from 61% to 47%).||||||0.47|||||||Regression, Logistic|||We will compare the percentages of patients who received their preferred screening in the 12 months after the visit across the two groups using logistic regression model with the GEE approach to adjust for clustering of patients within clinicians.||||0.47
72447515|NCT03959696|144412488|SUPERIORITY||Mean Difference (Final Values)|0.53||||0.19|TWO_SIDED||||||t-test, 2 sided|||||||0.19
72447516|NCT03959696|144412489|SUPERIORITY||Risk Difference (RD)|9.4||||0.032|TWO_SIDED|95.0|0.9|18.0|||Chi-squared|||Null hypothesis was equal screening rate in both arms||18.0|0.9|0.032
72447517|NCT03959696|144412490|SUPERIORITY||Risk Difference (RD)|1.5||||0.64|TWO_SIDED||||||Chi-squared|||||||0.64
72498264|NCT02054702|144526941|SUPERIORITY_OR_OTHER|||||||0.9716|TWO_SIDED||||||ANCOVA|The ANCOVA model, with treatment group as main effect and total score at baseline as covariate, was used for change from baseline comparisons.||Statistical analysis is mean change in BIS-11 item total score from baseline to week 6 for aripiprazole.||||0.9716
72498265|NCT02304926|144526958|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
72498266|NCT02304926|144526959|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
72498267|NCT02304926|144526960|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
72498268|NCT02304926|144526961|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||||||>0.05
72498269|NCT02304926|144526962|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||||||>0.05
72498270|NCT02304926|144526963|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
72498271|NCT02304926|144526964|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
72498272|NCT02304926|144526965|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
72498273|NCT02304926|144526966|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
72498274|NCT02304926|144526967|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
72498275|NCT02304926|144526968|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
72498276|NCT02304926|144526969|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
72498277|NCT02304926|144526970|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
72498278|NCT02304926|144526971|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
72498279|NCT02304926|144526972|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
72498280|NCT02304926|144526973|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
72498281|NCT02304926|144526974|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
72561410|NCT01525628|144653434|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 17 vs. Day 9 (%)|408.66|STANDARD_DEVIATION|45.9||1|TWO_SIDED|90.0|315.15|529.9|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of BI CD 6168 at Day 17 vs. Day 9 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 17 vs. Day 9||529.90|315.15|1.0000
72619395|NCT00098293|144769636|SUPERIORITY_OR_OTHER||Difference in Percentage|0.6|||||ONE_SIDED|97.5|-6.4|||||||Less than 400 copies/mL: Treatment difference in percentage stratified by randomization strata was presented along with the lower bound of the 1-sided 97.5% CI based on the normal approximation to the binomial distribution. Positive value would favor maraviroc. Due to its post-hoc nature, this analysis was considered descriptive only rather than inferential.|||-6.4|
72498282|NCT02304926|144526975|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||||||>0.05
72390472|NCT04115839|144288612|SUPERIORITY||Difference in response rates|0.0|||||TWO_SIDED|95.0|-24.5|24.5|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||24.5|-24.5|
72498283|NCT02304926|144526976|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
72498284|NCT02304926|144526977|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
72390473|NCT04115839|144288612|SUPERIORITY||Difference in response rates|-0.8|||||TWO_SIDED|95.0|-23.9|22.4|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||22.4|-23.9|
72390474|NCT04115839|144288612|SUPERIORITY||Difference in response rates|13.3|||||TWO_SIDED|95.0|-10.8|37.4|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 8||37.4|-10.8|
72390475|NCT04115839|144288612|SUPERIORITY||Difference in response rates|5.9|||||TWO_SIDED|95.0|-11.8|23.6|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 8||23.6|-11.8|
72390476|NCT04115839|144288612|SUPERIORITY||Difference in response rates|-14.8|||||TWO_SIDED|95.0|-46.6|17.1|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 12||17.1|-46.6|
72390477|NCT04115839|144288612|SUPERIORITY||Difference in response rates|-15.5|||||TWO_SIDED|95.0|-46.3|15.2|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 12||15.2|-46.3|
72390478|NCT04115839|144288612|SUPERIORITY||Difference in response rates|21.4|||||TWO_SIDED|95.0|-13.0|55.8|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||55.8|-13.0|
72390479|NCT04115839|144288612|SUPERIORITY||Difference in response rates|4.6|||||TWO_SIDED|95.0|-22.3|31.5|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||31.5|-22.3|
72390480|NCT04115839|144288614|SUPERIORITY||Difference in response rates|0.0|||||TWO_SIDED|95.0|-6.7|6.7|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||6.7|-6.7|
72390481|NCT04115839|144288614|SUPERIORITY||Difference in response rates|5.9|||||TWO_SIDED|95.0|-11.6|23.3|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||23.3|-11.6|
72390482|NCT04115839|144288614|SUPERIORITY||Difference in response rates|6.7|||||TWO_SIDED|95.0|-12.9|26.2|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 8||26.2|-12.9|
72390483|NCT04115839|144288614|SUPERIORITY||Difference in response rates|5.9|||||TWO_SIDED|95.0|-11.8|23.6|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 8||23.6|-11.8|
72390484|NCT04115839|144288614|SUPERIORITY||Difference in response rates|0.0|||||TWO_SIDED|95.0|-6.9|6.9|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 12||6.9|-6.9|
72498285|NCT02388295|144526981|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.38|STANDARD_ERROR_OF_MEAN|0.24||0.13|ONE_SIDED|||||Not adjusted|ANOVA||larger negative values (powered to detect -0.50)|Change from baseline within treatment arm||||0.13
72498286|NCT02388295|144526981|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.03|STANDARD_ERROR_OF_MEAN|0.25||0.91|ONE_SIDED|||||not adjusted|ANOVA||larger negative values (powered to detect -0.50)|Change from baseline||||0.91
72498287|NCT02388295|144526981|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.25||0.68|ONE_SIDED||||||ANOVA|no adjustments|larger negagtive values (powereed to detect -0.50)|Change from baseline||||0.68
72498288|NCT02388295|144526981|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.35|STANDARD_ERROR_OF_MEAN|0.34||0.32|TWO_SIDED|||||no adjustment|ANOVA||Looking for negative direction to indicate treatment better than placebo|Secondary objective - comparison to placebo||||0.32
72498289|NCT02388295|144526981|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.28|STANDARD_ERROR_OF_MEAN|0.36||0.45|TWO_SIDED|||||no adjustment|ANOVA||lookin for negative difference compared to placebo|Secondary objective||||0.45
72498290|NCT02076165|144526986|SUPERIORITY||||||=|0.12|||||||Fisher Exact|||Percentage of participants who completed all 5 treatment sessions, comparing ABC-I to CBT-I.||||=.120
72447518|NCT05337306|144412516|SUPERIORITY|ANCOVA controlling for study arm and baseline||||||0.049||||||a priori threshold .05; no adjustment for multiple comparisons|ANCOVA|covariates include arm and baseline level of outcome||Last Observation Carried Forward (LOCF) for those lost to follow up; null hypothesis group 1 follow-up outcome = group 2 follow-up outcome.||||.049
72447519|NCT05337306|144412517|SUPERIORITY|||||||0.04||||||a priori threshold .05; no adjustment for multiple comparisons|ANCOVA|Covariates include trial arm and baseline level of outcome.||LOCF for lost to follow-up||||.040
72447520|NCT05337306|144412518|SUPERIORITY|||||||0.22|||||||ANCOVA|covariates include trial arm and baseline level of outcome.||LOCF for dropout/lost to follow up||||.220
72447521|NCT03808818|144412579|EQUIVALENCE|the smallest detectable difference will be 22%|Odds Ratio (OR)|2.3||||0.0046|TWO_SIDED|95.0|1.28|4.13||No correction for multiple comparisons|Chi-squared|||"For self-reported 7-day point prevalence abstinence at 6-months, with a sample size of 140 in each arm then smallest detectable difference will be 22% with 80% power. Subsequent analyses will use a Bonferroni corrected alpha of 0.002 using with an estimated control rate of 31%.~The primary analysis will be performed from an intent-to-treat perspective. Chi-square tests will be used to compare the outcomes between treatment groups."||4.13|1.28|0.0046
72447522|NCT03808818|144412580|EQUIVALENCE|the smallest detectable difference will be 22% with 80% power and a Bonferroni corrected alpha of 0.002 using and an estimated control rate of 28%.|Odds Ratio (OR)|1.86||||0.035|TWO_SIDED|95.0|1.04|3.33|||Chi-squared|||7-day point prevalence abstinence at 3-months, with a sample size of 140 in each arm then smallest detectable difference will be 18% with 80% power and a Bonferroni corrected alpha of 0.002 using and an estimated control rate of 20%||3.33|1.04|0.035
72447523|NCT03808818|144412581|EQUIVALENCE|the smallest detectable difference will be 21% with 80% power and a Bonferroni corrected alpha of 0.002 and an estimated control rate of 20%.||||||0.016|||||||Chi-squared|||power calculations assumed a sample size of 140 in each arm and a Bonferroni corrected alpha of 0.002 and an estimated control rate of 20%||||0.016
72447524|NCT03808818|144412583|EQUIVALENCE|no margin||||||0.069|||||||Chi-squared|||||||0.069
72447525|NCT03808818|144412584|EQUIVALENCE|no margin||||||0.86|||||||Chi-squared|||||||0.86
72498291|NCT02076165|144526987|SUPERIORITY||Mean Difference (Final Values)|-0.711|STANDARD_ERROR_OF_MEAN|3.59|=|0.843|TWO_SIDED|95.0|-7.75|6.32|||Mixed Models Analysis||The average deviation, in minutes, between the recommended and actual bed time. Negative values indicate the number of minutes earlier than the recommended bed time that the participant went to bed, indicating greater non-adherence.|||6.32|-7.75|=.843
72498292|NCT02076165|144526988|SUPERIORITY||Mean Difference (Final Values)|-2.78|STANDARD_ERROR_OF_MEAN|5.17|=|0.59|TWO_SIDED|95.0|-12.91|7.35|||Mixed Models Analysis||The average deviation, in minutes, between the recommended and actual rise time. Positive values indicate the number of minutes later than the recommended rise time that the participant got out of bed, indicating greater non-adherence.|||7.35|-12.91|=0.590
72498293|NCT02076165|144526989|SUPERIORITY||Mean Difference (Final Values)|0.001|STANDARD_ERROR_OF_MEAN|0.048|=|0.979|TWO_SIDED|95.0|-0.093|0.096|||Mixed Models Analysis||The proportion of nights participants who did not follow the recommendation to get out of bed if awake more than 20 minutes. Higher numbers indicate greater non-adherence.|||0.096|-0.093|=0.979
72498294|NCT02076165|144526990|NON_INFERIORITY|We elected to use a value of δ equivalent to an effect size of d=0.40. (i.e., 4/10ths SD). For sleep diary estimated sleep efficiency, this represents a difference of 5%.|Mean Difference (Net)|0.409|STANDARD_ERROR_OF_MEAN|2.02|=|0.004|TWO_SIDED|90.0|-2.92|3.74|||Mixed Models Analysis||The parameter estimate is the improvement in sleep efficiency from baseline to post-treatment for ABCI group versus the same improvement in the CBTI group.|||3.74|-2.92|=0.004
72498295|NCT02076165|144526991|NON_INFERIORITY|We elected to use a value of δ equivalent to an effect size of d=0.40. (i.e., 4/10ths SD). For sleep diary estimated sleep efficiency, this represents a difference of 5%.|Mean Difference (Net)|0.757|STANDARD_ERROR_OF_MEAN|2.12||0.003|TWO_SIDED|90.0|-2.72|4.23|||Mixed Models Analysis||The parameter estimate is the improvement in sleep efficiency from baseline to 3-month follow-up for ABCI group versus the same improvement in the CBTI group.|||4.23|-2.72|.003
72498296|NCT02076165|144526992|NON_INFERIORITY|We elected to use a value of δ equivalent to an effect size of d=0.40. (i.e., 4/10ths SD). For actigraphically-estimated sleep efficiency, this represents a difference of 5%.|Mean Difference (Net)|0.68|STANDARD_ERROR_OF_MEAN|1.15|<|0.001|TWO_SIDED|90.0|-1.21|2.57|||Mixed Models Analysis||The parameter estimate is the improvement in sleep efficiency from baseline to post-treatment for ABCI group versus the same improvement in the CBTI group.|||2.57|-1.21|<0.001
72447526|NCT03808818|144412596|EQUIVALENCE|No equivalence margin|||||<|0.0001||||||Alpha level 0.01|Fisher Exact|||Fisher's exact tests were performed to assess the differences between the VST and EUC arms on the 6-month questionnaire.||||<.0001
72447527|NCT03808818|144412597|EQUIVALENCE|No equivalence margin|||||<|0.0001||||||Alpha level 0.01|Fisher Exact|||Fisher's exact tests were performed to assess the differences between the VST and EUC arms on the 6-month questionnaire.||||<.0001
72447528|NCT03808818|144412598|EQUIVALENCE|No equivalence margin|||||<|0.0001||||||Alpha level 0.01|Fisher Exact|||Fisher's exact tests were performed to assess the differences between the VST and EUC arms on the 6-month questionnaire.||||<.0001
72447529|NCT03808818|144412600|EQUIVALENCE|No equivalence margin|||||<|0.0001||||||Alpha level 0.01|Fisher Exact|||Fisher's exact tests were performed to assess the differences between the VST and EUC arms on the 6-month questionnaire.||||<.0001
72447530|NCT02547363|144412612|SUPERIORITY||||||<|0.001|||||||Fisher exact test|||||||<0.001
72447531|NCT02547363|144412613|SUPERIORITY||Ratio of clearance rates|62.59|||<|0.001|TWO_SIDED|95.0|8.68|451.08|||Mantel Haenszel||Mantel-Haenszel estimate (0.037% relative to vehicle), adjusted for pooled sites.|The p-values for secondary endpoints have been corrected by the Holm-Bonferroni method to account for multiplicity. The prespecified multiplicity adjustment by the Holm-Bonferroni method requires the ordering of the p-values for the secondary endpoints by size.||451.08|8.68|<0.001
72447532|NCT02547363|144412614|SUPERIORITY||Ratio of clearance rates|59.21|||<|0.001|TWO_SIDED|95.0|8.44|415.35|||Mantel Haenszel||Mantel-Haenszel estimate (0.037% relative to vehicle), adjusted for pooled sites.|The p-values for secondary endpoints have been corrected by the Holm-Bonferroni method to account for multiplicity. The prespecified multiplicity adjustment by the Holm-Bonferroni method requires the ordering of the p-values for the secondary endpoints by size.||415.35|8.44|<0.001
72498297|NCT02076165|144526993|NON_INFERIORITY|We elected to use a value of δ equivalent to an effect size of d=0.40. (i.e., 4/10ths SD). For actigraphically-estimated sleep efficiency, this represents a difference of 5%.|Mean Difference (Net)|1.11|STANDARD_ERROR_OF_MEAN|1.37|<|0.001|TWO_SIDED|90.0|-1.14|3.36|||Mixed Models Analysis||The parameter estimate is the improvement in sleep efficiency from baseline to 3-month follow-up for ABCI group versus the same improvement in the CBTI group.|||3.36|-1.14|<.001
72498298|NCT02076165|144526994|NON_INFERIORITY|We elected to use a value of δ equivalent to an effect size of d=0.40. (i.e., 4/10ths SD). With respect to ISI, this represents a 2 point difference between the treatment effects.|Mean Difference (Net)|0.501|STANDARD_ERROR_OF_MEAN|0.9|=|0.048|TWO_SIDED|90.0|-0.98|1.98|||Mixed Models Analysis||The parameter estimate is the improvement in the ISI score from baseline to post-treatment for ABCI group versus the same improvement in the CBTI group.|||1.98|-0.98|=0.048
72498299|NCT02076165|144526995|NON_INFERIORITY|We elected to use a value of δ equivalent to an effect size of d=0.40. (i.e., 4/10ths SD). With respect to ISI, this represents a 2 point difference between the treatment effects.|Mean Difference (Net)|-0.57|STANDARD_ERROR_OF_MEAN|1.06|=|0.008|TWO_SIDED|90.0|-2.32|1.17|||Mixed Models Analysis||The parameter estimate is the improvement in the ISI score from baseline to 3-month follow-up for ABCI group versus the same improvement in the CBTI group.|||1.17|-2.32|=0.008
72498300|NCT00109473|144527011|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|14.0||||0.02|TWO_SIDED|95.0|||||Mixed Models Analysis|||||||0.02
72498301|NCT03417440|144527024|SUPERIORITY||Estimated mean change|-898.0||||0.37|TWO_SIDED|95.0|-2884.82|1088.82||A single model was run including variables indicating Proof Positive (yes/no), Coach Me (yes/no), and On Your Feet (yes/no) and their interaction terms.|Mixed Models Analysis|||The original mixed effects regression model effects consisted of three treatment main effects, three two-way treatment interactions, and one three-way treatment interaction. Values are unadjusted.||1088.82|-2884.82|.37
72498302|NCT03417440|144527024|SUPERIORITY||Estimated mean change|-2602.1||||0.02|TWO_SIDED|95.0|-4687.44|-516.69||A single model was run including variables indicating Proof Positive (yes/no), Coach Me (yes/no), and On Your Feet (yes/no) and their interaction terms.|Mixed Models Analysis|||The original mixed effects regression model effects consisted of three treatment main effects, three two-way treatment interactions, and one three-way treatment interaction. Values are unadjusted.||-516.69|-4687.44|.02
72561411|NCT01525628|144653434|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 66 vs. Day 9 (%)|301.19|STANDARD_DEVIATION|62.1||0.9993|TWO_SIDED|90.0|204.61|443.35|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of BI CD 6168 at Day 66 vs. Day 9 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 66 vs. Day 9||443.35|204.61|0.9993
72390485|NCT04115839|144288614|SUPERIORITY||Difference in response rates|5.9|||||TWO_SIDED|95.0|-11.8|23.6|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 12||23.6|-11.8|
72390486|NCT04115839|144288614|SUPERIORITY||Difference in response rates|0.0|||||TWO_SIDED|95.0|-7.1|7.1|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||7.1|-7.1|
72390487|NCT04115839|144288614|SUPERIORITY||Difference in response rates|5.9|||||TWO_SIDED|95.0|-11.8|23.6|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||23.6|-11.8|
72390488|NCT04115839|144288622|SUPERIORITY||LS Mean Treatment Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.066||0.19|TWO_SIDED|95.0|-0.22|0.04||P-value was provided from MMRM including treatment, visit (categorical), treatment by visit, stratification factors, baseline value as fixed effects, participants being the random effect.|MMRM|||Week 2||0.04|-0.22|0.19
72390489|NCT04115839|144288622|SUPERIORITY||LS Mean Treatment Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.067||0.84|TWO_SIDED|95.0|-0.15|0.12||P-value was provided from MMRM including treatment, visit (categorical), treatment by visit, stratification factors, baseline value as fixed effects, participants being the random effect.|MMRM|||Week 2||0.12|-0.15|0.84
72390490|NCT04115839|144288622|SUPERIORITY||LS Mean Treatment Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.073||0.3|TWO_SIDED|95.0|-0.22|0.07||P-value was provided from MMRM including treatment, visit (categorical), treatment by visit, stratification factors, baseline value as fixed effects, participants being the random effect.|MMRM|||Week 4||0.07|-0.22|0.30
72390491|NCT04115839|144288622|SUPERIORITY||LS Mean Treatment Difference|0.01|STANDARD_ERROR_OF_MEAN|0.074||0.89|TWO_SIDED|95.0|-0.14|0.16||P-value was provided from MMRM including treatment, visit (categorical), treatment by visit, stratification factors, baseline value as fixed effects, participants being the random effect.|MMRM|||Week 4||0.16|-0.14|0.89
72390492|NCT04115839|144288622|SUPERIORITY||LS Mean Treatment Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.096||0.064|TWO_SIDED|95.0|-0.37|0.01||P-value was provided from MMRM including treatment, visit (categorical), treatment by visit, stratification factors, baseline value as fixed effects, participants being the random effect.|MMRM|||Week 8||0.01|-0.37|0.064
72390493|NCT04115839|144288622|SUPERIORITY||LS Mean Treatment Difference|0.01|STANDARD_ERROR_OF_MEAN|0.096||0.88|TWO_SIDED|95.0|-0.17|0.2||P-value was provided from MMRM including treatment, visit (categorical), treatment by visit, stratification factors, baseline value as fixed effects, participants being the random effect.|MMRM|||Week 8||0.20|-0.17|0.88
72390494|NCT04115839|144288622|SUPERIORITY||LS Mean Treatment Difference|-0.23|STANDARD_ERROR_OF_MEAN|0.099||0.023|TWO_SIDED|95.0|-0.43|-0.03||P-value was provided from MMRM including treatment, visit (categorical), treatment by visit, stratification factors, baseline value as fixed effects, participants being the random effect.|MMRM|||Week 12||-0.03|-0.43|0.023
72390495|NCT04115839|144288622|SUPERIORITY||LS Mean Treatment Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.099||0.75|TWO_SIDED|95.0|-0.23|0.17||P-value was provided from MMRM including treatment, visit (categorical), treatment by visit, stratification factors, baseline value as fixed effects, participants being the random effect.|MMRM|||Week 12||0.17|-0.23|0.75
72390496|NCT04115839|144288622|SUPERIORITY||LS Mean Treatment Difference|-0.31|STANDARD_ERROR_OF_MEAN|0.106||0.005|TWO_SIDED|95.0|-0.51|-0.1||P-value was provided from MMRM including treatment, visit (categorical), treatment by visit, stratification factors, baseline value as fixed effects, participants being the random effect.|MMRM|||Week 16||-0.10|-0.51|0.005
72498303|NCT03417440|144527024|SUPERIORITY||Estimated mean change|-1244.9||||0.23|TWO_SIDED|95.0|-3287.6|797.85|||Mixed Models Analysis|||The original mixed effects regression model effects consisted of three treatment main effects, three two-way treatment interactions, and one three-way treatment interaction. Values are unadjusted.||797.85|-3287.60|.23
72498304|NCT03417440|144527024|SUPERIORITY||Estimated mean change|1468.5||||0.31|TWO_SIDED|95.0|-1368.93|4306.02|||Mixed Models Analysis|||The original mixed effects regression model effects consisted of three treatment main effects, three two-way treatment interactions, and one three-way treatment interaction. Values are unadjusted.||4306.02|-1368.93|0.31
72498305|NCT03417440|144527024|SUPERIORITY||Estimated mean change|388.1||||0.78|TWO_SIDED|95.0|-2397.51|3173.62|||Mixed Models Analysis|||The original mixed effects regression model effects consisted of three treatment main effects, three two-way treatment interactions, and one three-way treatment interaction. Values are unadjusted.||3173.62|-2397.51|0.78
72498306|NCT03417440|144527024|SUPERIORITY||Estimated mean change|1991.2||||0.17|TWO_SIDED|95.0|-865.52|4847.86|||Mixed Models Analysis|||The original mixed effects regression model effects consisted of three treatment main effects, three two-way treatment interactions, and one three-way treatment interaction. Values are unadjusted.||4847.86|-865.52|0.17
72498307|NCT03417440|144527024|SUPERIORITY||Estimated mean change|-590.7||||0.77|TWO_SIDED|95.0|-4591.17|3409.75|||Mixed Models Analysis|||The original mixed effects regression model effects consisted of three treatment main effects, three two-way treatment interactions, and one three-way treatment interaction. Values are unadjusted.||3409.75|-4591.17|0.77
72498308|NCT03417440|144527025|SUPERIORITY||Mean Difference (Net)|-23.0|STANDARD_DEVIATION|118.7||0.17|ONE_SIDED|90.0||8.3||a priori threshold for statistical significance=0.1 for 1-sided t-test; no adjustments for multiple comparisons made; if the outcome is not in the hypothesized direction, values that meet or exceed the 0.1 threshold will not be considered significant|t-test, 1 sided|||||8.3||0.17
72390497|NCT04115839|144288622|SUPERIORITY||LS Mean Treatment Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.105||0.54|TWO_SIDED|95.0|-0.27|0.14||P-value was provided from MMRM including treatment, visit (categorical), treatment by visit, stratification factors, baseline value as fixed effects, participants being the random effect.|MMRM|||Week 16||0.14|-0.27|0.54
72390498|NCT04115839|144288624|SUPERIORITY||LS Mean Treatment Difference|1.3|STANDARD_ERROR_OF_MEAN|1.64||0.43|TWO_SIDED|95.0|-1.9|4.5||P-value was provided from MMRM including treatment, visit (categorical), treatment by visit, stratification factors, baseline value as fixed effects, participants being the random effect.|MMRM|||Week 4||4.5|-1.9|0.43
72390499|NCT04115839|144288624|SUPERIORITY||LS Mean Treatment Difference|-0.4|STANDARD_ERROR_OF_MEAN|1.64||0.81|TWO_SIDED|95.0|-3.6|2.9||P-value was provided from MMRM including treatment, visit (categorical), treatment by visit, stratification factors, baseline value as fixed effects, participants being the random effect.|MMRM|||Week 4||2.9|-3.6|0.81
72390500|NCT04115839|144288624|SUPERIORITY||LS Mean Treatment Difference|5.1|STANDARD_ERROR_OF_MEAN|2.43||0.04|TWO_SIDED|95.0|0.2|9.9||P-value was provided from MMRM including treatment, visit (categorical), treatment by visit, stratification factors, baseline value as fixed effects, participants being the random effect.|MMRM|||Week 16||9.9|0.2|0.040
72390501|NCT04115839|144288624|SUPERIORITY||LS Mean Treatment Difference|1.4|STANDARD_ERROR_OF_MEAN|2.41||0.58|TWO_SIDED|95.0|-3.4|6.1||P-value was provided from MMRM including treatment, visit (categorical), treatment by visit, stratification factors, baseline value as fixed effects, participants being the random effect.|MMRM|||Week 16||6.1|-3.4|0.58
72390502|NCT04115839|144288628|SUPERIORITY||LS Mean Treatment Difference|0.9|STANDARD_ERROR_OF_MEAN|1.09||0.4|TWO_SIDED|95.0|-1.2|3.1||P-value was provided from MMRM including treatment, visit (categorical), treatment by visit, stratification factors, baseline value as fixed effects, participants being the random effect.|MMRM|||Week 4||3.1|-1.2|0.40
72390503|NCT04115839|144288628|SUPERIORITY||LS Mean Treatment Difference|1.2|STANDARD_ERROR_OF_MEAN|1.1||0.28|TWO_SIDED|95.0|-1.0|3.4||P-value was provided from MMRM including treatment, visit (categorical), treatment by visit, stratification factors, baseline value as fixed effects, participants being the random effect.|MMRM|||Week 4||3.4|-1.0|0.28
72390504|NCT04115839|144288628|SUPERIORITY||LS Mean Treatment Difference|3.8|STANDARD_ERROR_OF_MEAN|1.46||0.011|TWO_SIDED|95.0|0.9|6.7||P-value was provided from MMRM including treatment, visit (categorical), treatment by visit, stratification factors, baseline value as fixed effects, participants being the random effect.|MMRM|||Week 16||6.7|0.9|0.011
72390505|NCT04115839|144288628|SUPERIORITY||LS Mean Treatment Difference|2.1|STANDARD_ERROR_OF_MEAN|1.45||0.14|TWO_SIDED|95.0|-0.7|5.0||P-value was provided from MMRM including treatment, visit (categorical), treatment by visit, stratification factors, baseline value as fixed effects, participants being the random effect.|MMRM|||Week 16||5.0|-0.7|0.14
72390506|NCT00621985|144288661|SUPERIORITY_OR_OTHER||Percent Difference|-19.0||||0.09||95.0|||||t-test, 2 sided|||"A t-test was performed comparing the mean long transformed area under the curve of 17-hydroxyprogesterone between the dexamethasone and hydrocortisone arms. The percent difference in mean log AUC was calculated as:~(Mean log AUC on dexamethasone - Mean log AUC on hydrocortisone)/Mean log AUC on hydrocortisone"||||0.09
72390507|NCT02577510|144288664|OTHER|||||||0.05|||||||t-test, 1 sided|||Statistical analysis was performed using SPSS Version 21 statistical software (IBM, Armonk, New York). For continuous data, normality was fi rst assessed with the Lilliefors test and then analyzed using a paired t test. Data that did not have a normal distribution, as well as ordinal data, was analyzed using Wilcoxon's signed ranks or McNemar's test. All P values presented were 2-sided and values inferior to 0.05 were considered signifi cant||||0.05
72390508|NCT03535844|144288695|SUPERIORITY|||||||0.49|||||||t-test, 2 sided|independent t-test of change values||||||0.49
72390509|NCT03535844|144288695|SUPERIORITY|||||||0.5672|||||||t-test, 1 sided|Paired t-test (Week 0 and Week 16)||||||0.5672
72390510|NCT03535844|144288695|SUPERIORITY|||||||0.788|||||||t-test, 2 sided|Paired t-test of change values||||||0.788
72390511|NCT03535844|144288696|SUPERIORITY|||||||0.67|||||||t-test, 2 sided|independent t-test of change values||||||0.67
72390512|NCT03535844|144288696|SUPERIORITY|||||||0.8203|||||||t-test, 2 sided|Paired t-test of change values||||||0.8203
72390513|NCT03535844|144288696|SUPERIORITY|||||||0.3882|||||||t-test, 2 sided|Paired t-test of change values||||||0.3882
72447533|NCT02547363|144412615|SUPERIORITY||Week 8 AK count ratio|0.27|||<|0.001|TWO_SIDED|95.0|0.23|0.32|||Mantel Haenszel||0.037% relative to vehicle.|The p-values for secondary endpoints have been corrected by the Holm-Bonferroni method to account for multiplicity. The prespecified multiplicity adjustment by the Holm-Bonferroni method requires the ordering of the p-values for the secondary endpoints by size.||0.32|0.23|<0.001
72447534|NCT05977530|144412699|SUPERIORITY||comparison of ranks in Wilcoxon|0.0|||<|0.01|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<.01
72447535|NCT05692960|144412703|SUPERIORITY|For this feasibility study, a sample of approximately 15 participants per arm will allow for estimates that can be used in the development of a larger study.|FSFI Total, HRI Cohen's d|1.37|||||TWO_SIDED|95.0|0.62|2.1||||||Effect sizes, Cohen's d, were calculated for both study arms using paired t-tests for FSFI total, FSFI lubrication, FSFI pain, and FSFI desire subscales. Means and 95% confidence intervals were also calculated.||2.10|.62|
72447536|NCT05692960|144412703|SUPERIORITY||FSFI Total, VVA Cohen's d|1.63|||||TWO_SIDED|95.0|0.86|2.37||||||||2.37|.86|
72447537|NCT05692960|144412703|SUPERIORITY||FSFI Lubrication, HRI Cohen's d|1.2|||||TWO_SIDED|95.0|0.49|1.87||||||||1.87|.49|
72447538|NCT05692960|144412703|SUPERIORITY||FSFI Lubrication, VVA Cohen's d|1.85|||||TWO_SIDED|95.0|1.02|2.66||||||||2.66|1.02|
72447539|NCT05692960|144412703|SUPERIORITY||FSFI Pain, HRI Cohen's d|0.77|||||TWO_SIDED|95.0|0.16|1.36||||||||1.36|.16|
72447540|NCT05692960|144412703|SUPERIORITY||FSFI Pain, VVA Cohen's d|0.82|||||TWO_SIDED|95.0|0.24|1.38||||||||1.38|.24|
72447541|NCT05692960|144412703|SUPERIORITY||FSFI Desire, HRI Cohen's d|1.15|||||TWO_SIDED|95.0|0.46|1.82||||||||1.82|.46|
72447542|NCT05692960|144412703|SUPERIORITY||FSFI Desire, VVA Cohen's d|1.21|||||TWO_SIDED|95.0|0.55|1.86||||||||1.86|.55|
72447543|NCT05692960|144412704|SUPERIORITY|For this feasibility study, a sample of approximately 15 participants per arm will allow for estimates that can be used in the development of a larger study.|BITS, HRI Cohen's d|1.0|||||TWO_SIDED|95.0|0.34|1.63||||||Effect sizes, Cohen's d, were calculated for both study arms using paired t-tests for the BITS. Means and 95% confidence intervals were also calculated.||1.63|.34|
72447544|NCT05692960|144412704|SUPERIORITY||BITS, VVA Cohen's d|0.5|||||TWO_SIDED|95.0|0.03|1.01||||||||1.01|.03|
72447545|NCT05692960|144412705|SUPERIORITY|For this feasibility study, a sample of approximately 15 participants per arm will allow for estimates that can be used in the development of a larger study.|PROMIS Interest, HRI Cohen's d|1.1|||||TWO_SIDED|95.0|0.41|1.75||||||Effect sizes, Cohen's d, were calculated for both study arms using paired t-test for PROMIS interest, lubrication and satisfaction subscales. Means and 95% confidence intervals were also calculated.||1.75|.41|
72447546|NCT05692960|144412705|SUPERIORITY||PROMIS Interest, VVA Cohen's d|0.64|||||TWO_SIDED|95.0|0.09|1.18||||||||1.18|.09|
72447547|NCT05692960|144412705|SUPERIORITY||PROMIS Satisfaction, HRI Cohen's d|1.19|||||TWO_SIDED|95.0|0.45|1.89||||||||1.89|.45|
72447548|NCT05692960|144412705|SUPERIORITY||PROMIS Satisfaction, VVA Cohen's d|0.8|||||TWO_SIDED|95.0|0.13|1.44||||||||1.44|.13|
72447549|NCT05692960|144412705|SUPERIORITY||PROMIS Lubrication, HRI Cohen's d|1.79|||||TWO_SIDED|95.0|0.88|2.67||||||||2.67|.88|
72447550|NCT05692960|144412705|SUPERIORITY||PROMIS Lubrication, VVA Cohen's d|1.63|||||TWO_SIDED|95.0|0.74|2.5||||||||2.50|.74|
72447551|NCT04382664|144412706|SUPERIORITY||Hazard Ratio (HR)|0.95||||0.845|TWO_SIDED|80.0|0.694|1.309|||Regression, Cox|||||1.309|0.694|0.845
72447552|NCT05239455|144412751|OTHER|The FDA requires one-sided 95% lower confidence limit for the population proportion of success is greater than 70% where success of a unit is defined as the RBC in vivo 24-hour percentage recovery ≥ 75%. Allows for low recoveries (\<75%) in 2/20 or 3/24 volunteers.|95% Confidence Interval|88.5|||||ONE_SIDED|95.0|72.81||||||A one-sided confidence interval for the proportion of successes was determined using the Clopper-Pearson exact method for a 95% confidence interval.|The comparison is to the FDA requirements for in vivo 24-hour recovery of LR-RBC.|Proportion of successes greater than 70% where success of a unit is defined as the RBC in vivo 24-hour percentage recovery ≥ 75% was calculated.||72.81|
72447553|NCT05239455|144412752|OTHER|The FDA criteria requires LR-RBC mean 24-hour recovery ≥ 75% with standard deviation (SD) ≤ 9%||||||||||||||||The comparison is to the FDA requirements for in vivo 24-hour recovery of LR-RBC.|Mean and standard deviation were calculated.|||
72447554|NCT01799265|144412753|NON_INFERIORITY|The 95% upper limit of the prediction interval was calculated using the formula (μ ) ̂+t\_(k-2)\^α √((τ\^2 ) ̂+〖(SE) ̂(μ ̂ )〗\^2 ),where (μ ) ̂is the estimate average AHI across all studies, (τ\^2 ) ̂ is the between-study variation, t\_(k-2)\^α is the critical value for a t-distribution, k is the number of studies in the meta-analysis, and k-2 are the degrees of freedom for the t distribution. Meta-analyzed statistics to compute the prediction interval were (μ ) ̂=5.0, SE(μ ̂ )=0.9, and (τ\^2 ) ̂=8.0||||||0.05|||||||t-test, 1 sided|A p-value of .05 was used.||"Hypothesis testing for the primary endpoint was conducted using a one-sided test of non-inferiority with the following null and alternative hypotheses at the 0.05 significance level using the MIXED procedure in SAS, version 9.3:~H\_0:(ϕ\_m ) ̂≥6.9 H\_A:(ϕ\_m ) ̂\<6.9 where (ϕ\_m ) ̂ is the estimated AHI difference between Transcend Auto and REMstar Auto from the model described in 3.5.1."||||.05
72447555|NCT02364557|144412764|SUPERIORITY||Hazard Ratio (HR)|0.92||||0.36|TWO_SIDED|70.0|0.71|1.17||One-side significance level = 0.15|Log Rank||Reference level = SOC arm|Assuming an increase in median PFS from 10.5 to 19 months (HR: 0.55), 69 events provide \>90% power to conclude superiority with 1-sided α = 0.15.||1.17|0.71|0.36
72447556|NCT02364557|144412767|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.91|TWO_SIDED|95.0|0.59|1.61||Two-sided significance level = 0.05|Gray's test||Reference level = SOC arm|||1.61|0.59|0.91
72447557|NCT02364557|144412769|SUPERIORITY||Hazard Ratio (HR)|1.04||||0.9|TWO_SIDED|95.0|0.54|2.02||Two-sided significance level = 0.05.|Log Rank||Reference level = CTCs Absent|||2.02|0.54|0.90
72447558|NCT04828005|144412808|NON_INFERIORITY|Alternative hypothesis: Nalmefene reversal not less than 80% naloxone reversal|||||<|0.0009|||||||Mixed Models Analysis|||||||<0.0009
72447559|NCT05403827|144412818|SUPERIORITY|||||||0.5019|||||||Control-Based Mean Imputation|||||||0.5019
72447560|NCT05403827|144412819|SUPERIORITY|||||||0.2028|||||||Control-Based Mean Imputation|||||||0.2028
72447561|NCT05403827|144412820|SUPERIORITY|||||||0.1914|||||||Control-Based Mean Imputation|||||||0.1914
72447562|NCT05403827|144412821|SUPERIORITY|||||||0.2512|||||||Control-Based Mean Imputation|||||||0.2512
72447563|NCT05403827|144412822|SUPERIORITY|||||||0.7906|||||||Control-Based Mean Imputation|||||||0.7906
72447564|NCT05403827|144412823|SUPERIORITY|||||||0.5343|||||||Control-Based Mean Imputation|||||||0.5343
72447565|NCT05403827|144412824|SUPERIORITY|||||||0.3757|||||||Control-Based Mean Imputation|||||||0.3757
72498309|NCT03417440|144527025|SUPERIORITY||Mean Difference (Net)|37.7|STANDARD_DEVIATION|117.8||0.94|ONE_SIDED|90.0||68.8||a priori threshold for statistical significance=0.1 for 1-sided t-test; no adjustments for multiple comparisons made; if the outcome is not in the hypothesized direction, values that meet or exceed the 0.1 threshold will not be considered significant|t-test, 1 sided|||||68.8||0.94
72498310|NCT03417440|144527025|SUPERIORITY||Mean Difference (Net)|52.0|STANDARD_DEVIATION|116.4||0.99|ONE_SIDED|90.0||82.7||a priori threshold for statistical significance=0.1 for 1-sided t-test; no adjustments for multiple comparisons made; if the outcome is not in the hypothesized direction, values that meet or exceed the 0.1 threshold will not be considered significant|t-test, 1 sided|||||82.7||0.99
72498311|NCT03417440|144527026|SUPERIORITY||Mean Difference (Net)|0.8|STANDARD_DEVIATION|51.0||0.47|ONE_SIDED|90.0|-12.5|||a priori threshold for statistical significance=0.1 for 1-sided t-test; no adjustments for multiple comparisons made; if the outcome is not in the hypothesized direction, values that meet or exceed the 0.1 threshold will not be considered significant|t-test, 1 sided||||||-12.5|0.47
72498312|NCT03417440|144527026|SUPERIORITY||Mean Difference (Net)|5.0|STANDARD_DEVIATION|51.0||0.315|ONE_SIDED|90.0|-8.3|||a priori threshold for statistical significance=0.1 for 1-sided t-test; no adjustments for multiple comparisons made; if the outcome is not in the hypothesized direction, values that meet or exceed the 0.1 threshold will not be considered significant|t-test, 1 sided||||||-8.3|0.315
72498313|NCT03417440|144527026|SUPERIORITY||Mean Difference (Net)|3.9|STANDARD_DEVIATION|51.0||0.355|ONE_SIDED|90.0|-9.4|||a priori threshold for statistical significance=0.1 for 1-sided t-test; no adjustments for multiple comparisons made; if the outcome is not in the hypothesized direction, values that meet or exceed the 0.1 threshold will not be considered significant|t-test, 1 sided||||||-9.4|0.355
72498314|NCT03417440|144527027|SUPERIORITY||Mean Difference (Net)|-0.6|STANDARD_DEVIATION|1.0||0.86|ONE_SIDED|90.0|-1.3|||a priori threshold for statistical significance=0.1 for 1-sided t-test; no adjustments for multiple comparisons made; if the outcome is not in the hypothesized direction, values that meet or exceed the 0.1 threshold will not be considered significant|t-test, 1 sided||||||-1.3|0.86
72498315|NCT03417440|144527027|SUPERIORITY||Mean Difference (Net)|0.2|STANDARD_DEVIATION|1.0||0.38|ONE_SIDED|90.0|-0.6|||a priori threshold for statistical significance=0.1 for 1-sided t-test; no adjustments for multiple comparisons made; if the outcome is not in the hypothesized direction, values that meet or exceed the 0.1 threshold will not be considered significant|t-test, 1 sided||||||-0.6|0.38
72498316|NCT03417440|144527027|SUPERIORITY||Mean Difference (Net)|-0.3|STANDARD_DEVIATION|1.0||0.66|ONE_SIDED|90.0|-1.1|||a priori threshold for statistical significance=0.1 for 1-sided t-test; no adjustments for multiple comparisons made; if the outcome is not in the hypothesized direction, values that meet or exceed the 0.1 threshold will not be considered significant|t-test, 1 sided||||||-1.1|0.66
72498317|NCT03417440|144527028|SUPERIORITY||Mean Difference (Net)|-1.9|STANDARD_DEVIATION|19.2||0.69|ONE_SIDED|90.0|-6.9|||a priori threshold for statistical significance=0.1 for 1-sided t-test; no adjustments for multiple comparisons made; if the outcome is not in the hypothesized direction, values that meet or exceed the 0.1 threshold will not be considered significant|t-test, 1 sided||||||-6.9|0.69
72498318|NCT03417440|144527028|SUPERIORITY||Mean Difference (Net)|-1.0|STANDARD_DEVIATION|19.2||0.6|ONE_SIDED|90.0|-6.0|||a priori threshold for statistical significance=0.1 for 1-sided t-test; no adjustments for multiple comparisons made; if the outcome is not in the hypothesized direction, values that meet or exceed the 0.1 threshold will not be considered significant|t-test, 1 sided||||||-6.0|0.60
72498319|NCT03417440|144527028|SUPERIORITY||Mean Difference (Net)|4.8|STANDARD_DEVIATION|19.0||0.11|ONE_SIDED|90.0|-0.2|||a priori threshold for statistical significance=0.1 for 1-sided t-test; no adjustments for multiple comparisons made; if the outcome is not in the hypothesized direction, values that meet or exceed the 0.1 threshold will not be considered significant|t-test, 1 sided||||||-0.2|0.11
72498320|NCT03417440|144527029|SUPERIORITY||Mean Difference (Net)|-0.4|STANDARD_DEVIATION|1.0||0.94|ONE_SIDED|90.0|-0.7|||a priori threshold for statistical significance=0.1 for 1-sided t-test; no adjustments for multiple comparisons made; if the outcome is not in the hypothesized direction, values that meet or exceed the 0.1 threshold will not be considered significant|t-test, 1 sided||||||-0.7|0.94
72498321|NCT03417440|144527029|SUPERIORITY||Mean Difference (Net)|-0.1|STANDARD_DEVIATION|1.1||0.73|ONE_SIDED|90.0|-0.4|||a priori threshold for statistical significance=0.1 for 1-sided t-test; no adjustments for multiple comparisons made; if the outcome is not in the hypothesized direction, values that meet or exceed the 0.1 threshold will not be considered significant|t-test, 1 sided||||||-0.4|0.73
72390514|NCT03535844|144288697|SUPERIORITY|||||||0.08|||||||t-test, 2 sided|independent t-test of change values||||||0.08
72390515|NCT03535844|144288698|SUPERIORITY|||||||0.7162|||||||t-test, 2 sided|independent t-test of change values||||||0.7162
72390516|NCT03535844|144288698|SUPERIORITY|||||||0.07|||||||t-test, 2 sided|Paired t-test of Week 0 and Week 16 nitric oxide values||||||0.07
72390517|NCT03535844|144288698|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|Paired t-test of Week 0 and Week 16 nitric oxide values||||||<0.05
72390518|NCT03535844|144288699|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|Independent t-test of change values||||||<0.05
72390519|NCT03535844|144288700|SUPERIORITY|||||||0.4855|||||||t-test, 2 sided|Independent t-test of change triglyceride values||||||0.4855
72390520|NCT03535844|144288700|SUPERIORITY|||||||0.1393|||||||t-test, 2 sided|Independent t-test of change total cholesterol values||||||0.1393
72390521|NCT03535844|144288700|SUPERIORITY|||||||0.2221|||||||t-test, 2 sided|Independent t-test of change LDL cholesterol values||||||0.2221
72390522|NCT03535844|144288700|SUPERIORITY|||||||0.078|||||||t-test, 2 sided|Independent t-test of change HDL cholesterol values||||||0.078
72390523|NCT03535844|144288700|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|Paired t-test of Week 0 and Week 16 HDL cholesterol values||||||<0.05
72390524|NCT03535844|144288700|SUPERIORITY|||||||0.7261|||||||t-test, 2 sided|Paired t-test of Week 0 and Week 16 HDL cholesterol values||||||0.7261
72390525|NCT03535844|144288701|SUPERIORITY|||||||0.1951|||||||t-test, 2 sided|Independent t-test of systolic blood pressure change values||||||0.1951
72390526|NCT03535844|144288701|SUPERIORITY|||||||0.916|||||||t-test, 2 sided|Independent t-test of diastolic blood pressure change values||||||0.916
72390527|NCT03535844|144288702|SUPERIORITY|||||||0.9882|||||||t-test, 2 sided|independent t-test of malondialdehyde change values||||||0.9882
72390528|NCT03535844|144288703|SUPERIORITY|||||||0.4408|||||||t-test, 2 sided|Independent t-test of body fat % change values||||||0.4408
72447566|NCT03628924|144412874|SUPERIORITY||Treatment difference|12.6|||=|0.166|TWO_SIDED|95.0|-4.6|29.8|||Cochran-Mantel-Haenszel|||||29.8|-4.6|= 0.166
72447567|NCT03628924|144412874|SUPERIORITY||Treatment difference|6.6|||=|0.459|TWO_SIDED|95.0|-10.3|23.6|||Cochran-Mantel-Haenszel|||||23.6|-10.3|= 0.459
72447568|NCT06019559|144412904|SUPERIORITY|||||||0.0756||||||The threshold for statistical significance was p = 0.05.|Mixed Models Analysis|MMRM model with gender, treatment, visit and treatment-by-visit interaction as fixed effect, and baseline body weight as a covariate.||||||0.0756
72447569|NCT06019559|144412904|SUPERIORITY|||||||0.0008||||||The threshold for statistical significance was p = 0.05.|Mixed Models Analysis|(MMRM) model with gender, treatment, visit and treatment-by-visit interaction as fixed effect, and baseline body weight as a covariate.||For the primary endpoint of percentage change from baseline in body weight, a sample size of 150 participants (stratified by gender and randomized 1:1:1 into three treatment arms) provided \>95% power to detect a treatment difference of 4% weight reduction after 13 weeks of treatment with a 2-sided alpha of 0.05, assuming a standard deviation of 4% and 20% drop out.||||0.0008
72447570|NCT06019559|144412905|SUPERIORITY|||||||0.8366||||||The threshold for significance was p = 0.05.|Regression, Logistic|||||||0.8366
72447571|NCT06019559|144412905|SUPERIORITY|||||||0.1848||||||The threshold for significance was p = 0.05.|Regression, Logistic|||||||0.1848
72447572|NCT06019559|144412906|SUPERIORITY|||||||0.0616||||||The threshold for significance was p = 0.05.|Mixed Models Analysis|||||||0.0616
72447573|NCT06019559|144412906|SUPERIORITY|||||||0.0004||||||The threshold for significance was p = 0.05.|Mixed Models Analysis|||||||0.0004
72498322|NCT03417440|144527029|SUPERIORITY||Mean Difference (Net)|0.2|STANDARD_DEVIATION|1.1||0.22|ONE_SIDED|90.0|-0.1|||a priori threshold for statistical significance=0.1 for 1-sided t-test; no adjustments for multiple comparisons made; if the outcome is not in the hypothesized direction, values that meet or exceed the 0.1 threshold will not be considered significant|t-test, 1 sided||||||-0.1|0.22
72498323|NCT03417440|144527030|SUPERIORITY||Mean Difference (Net)|0.0|STANDARD_DEVIATION|1.3||0.46|ONE_SIDED|90.0|-0.3|||a priori threshold for statistical significance=0.1 for 1-sided t-test; no adjustments for multiple comparisons made; if the outcome is not in the hypothesized direction, values that meet or exceed the 0.1 threshold will not be considered significant|t-test, 1 sided||||||-0.3|0.46
72390529|NCT03535844|144288704|SUPERIORITY|||||||0.1487|||||||t-test, 2 sided|Independent t-test of change values||||||0.1487
72447574|NCT01814813|144412935|SUPERIORITY|||||||0.16|||||||Log Rank|||||||0.16
72498324|NCT03417440|144527030|SUPERIORITY||Mean Difference (Net)|-0.4|STANDARD_DEVIATION|1.2||0.96|ONE_SIDED|90.0|-0.7|||a priori threshold for statistical significance=0.1 for 1-sided t-test; no adjustments for multiple comparisons made; if the outcome is not in the hypothesized direction, values that meet or exceed the 0.1 threshold will not be considered significant|t-test, 1 sided||||||-0.7|0.96
72390530|NCT03535844|144288705|SUPERIORITY|||||||0.9135|||||||t-test, 2 sided|Independent t-test of change values||||||0.9135
72390531|NCT03535844|144288706|SUPERIORITY|||||||0.5859|||||||t-test, 2 sided|Independent t-test of change values||||||0.5859
72390532|NCT03535844|144288707|SUPERIORITY|||||||0.9379|||||||t-test, 2 sided|Independent t-test of change values||||||0.9379
72390533|NCT03535844|144288708|SUPERIORITY|||||||0.9717|||||||t-test, 2 sided|t-test of change values||||||0.9717
72447575|NCT01814813|144412936|SUPERIORITY||||||<|0.01|||||||Log Rank|||||||<0.01
72447576|NCT01814813|144412937|SUPERIORITY|||||||0.56|||||||Chi-squared|||||||0.56
72447577|NCT03858634|144412938|SUPERIORITY||Least squares (LS) mean difference|-3.3|STANDARD_ERROR_OF_MEAN|3.31||0.398|TWO_SIDED|80.0|-8.68|2.17||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||||2.17|-8.68|0.3980
72447578|NCT03858634|144412938|SUPERIORITY||LS mean difference|-0.5|STANDARD_ERROR_OF_MEAN|1.23||0.6653|TWO_SIDED|80.0|-2.17|1.09||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||||1.09|-2.17|0.6653
72447579|NCT03858634|144412938|SUPERIORITY||LS mean difference|-7.6|STANDARD_ERROR_OF_MEAN|2.14||0.0711|TWO_SIDED|80.0|-11.63|-3.56||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||||-3.56|-11.63|0.0711
72447580|NCT03858634|144412938|SUPERIORITY||LS mean difference|-3.1|STANDARD_ERROR_OF_MEAN|1.2||0.0186|TWO_SIDED|80.0|-4.7|-1.51||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||||-1.51|-4.70|0.0186
72447581|NCT03858634|144412940|SUPERIORITY||LS mean difference|-7.3|STANDARD_ERROR_OF_MEAN|14.76||0.6533|TWO_SIDED|80.0|-31.52|16.84||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 1||16.84|-31.52|0.6533
72447582|NCT03858634|144412940|SUPERIORITY||LS mean difference|-1.2|STANDARD_ERROR_OF_MEAN|10.51||0.9077|TWO_SIDED|80.0|-15.16|12.69||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 1||12.69|-15.16|0.9077
72447583|NCT03858634|144412940|SUPERIORITY||LS mean difference|-61.2|STANDARD_ERROR_OF_MEAN|33.18||0.2065|TWO_SIDED|80.0|-123.73|1.39||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 1||1.39|-123.73|0.2065
72447584|NCT03858634|144412940|SUPERIORITY||LS mean difference|-5.3|STANDARD_ERROR_OF_MEAN|3.19||0.1133|TWO_SIDED|80.0|-9.56|-1.07||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 1||-1.07|-9.56|0.1133
72447585|NCT03858634|144412940|SUPERIORITY||LS mean difference|-16.7|STANDARD_ERROR_OF_MEAN|21.76||0.4997|TWO_SIDED|80.0|-52.29|18.98||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 2||18.98|-52.29|0.4997
72447586|NCT03858634|144412940|SUPERIORITY||LS mean difference|-0.1|STANDARD_ERROR_OF_MEAN|11.85||0.9919|TWO_SIDED|80.0|-15.83|15.59||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 2||15.59|-15.83|0.9919
72447587|NCT03858634|144412940|SUPERIORITY||LS mean difference|-89.2|STANDARD_ERROR_OF_MEAN|28.56||0.0891|TWO_SIDED|80.0|-143.03|-35.31||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 2||-35.31|-143.03|0.0891
72447588|NCT03858634|144412940|SUPERIORITY||LS mean difference|-9.4|STANDARD_ERROR_OF_MEAN|5.47||0.1029|TWO_SIDED|80.0|-16.67|-2.12||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 2||-2.12|-16.67|0.1029
72447589|NCT03858634|144412940|SUPERIORITY||LS mean difference|-21.9|STANDARD_ERROR_OF_MEAN|32.93||0.5538|TWO_SIDED|80.0|-75.82|32.05||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 3||32.05|-75.82|0.5538
72447590|NCT03858634|144412940|SUPERIORITY||LS mean difference|-11.9|STANDARD_ERROR_OF_MEAN|11.78||0.3252|TWO_SIDED|80.0|-27.51|3.73||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 3||3.73|-27.51|0.3252
72447591|NCT03858634|144412940|SUPERIORITY||LS mean difference|-93.8|STANDARD_ERROR_OF_MEAN|34.1||0.1106|TWO_SIDED|80.0|-158.11|-29.52||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 3||-29.52|-158.11|0.1106
72447592|NCT03858634|144412940|SUPERIORITY||LS mean difference|-19.9|STANDARD_ERROR_OF_MEAN|7.17||0.0123|TWO_SIDED|80.0|-29.48|-10.4||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 3||-10.40|-29.48|0.0123
72447593|NCT03858634|144412940|SUPERIORITY||LS mean difference|-28.9|STANDARD_ERROR_OF_MEAN|35.86||0.4791|TWO_SIDED|80.0|-87.63|29.81||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 4||29.81|-87.63|0.4791
72447594|NCT03858634|144412940|SUPERIORITY||LS mean difference|-5.5|STANDARD_ERROR_OF_MEAN|12.66||0.6684|TWO_SIDED|80.0|-22.28|11.27||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 4||11.27|-22.28|0.6684
72447595|NCT03858634|144412940|SUPERIORITY||LS mean difference|-79.7|STANDARD_ERROR_OF_MEAN|26.28||0.0937|TWO_SIDED|80.0|-129.22|-30.13||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 4||-30.13|-129.22|0.0937
72447596|NCT03858634|144412940|SUPERIORITY||LS mean difference|-27.2|STANDARD_ERROR_OF_MEAN|9.75||0.012|TWO_SIDED|80.0|-40.21|-14.27||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 4||-14.27|-40.21|0.0120
72498325|NCT03417440|144527030|SUPERIORITY||Mean Difference (Net)|0.0|STANDARD_DEVIATION|1.3||0.495|ONE_SIDED|90.0|-0.3|||a priori threshold for statistical significance=0.1 for 1-sided t-test; no adjustments for multiple comparisons made; if the outcome is not in the hypothesized direction, values that meet or exceed the 0.1 threshold will not be considered significant|t-test, 1 sided||||||-0.3|0.495
72498326|NCT03417440|144527031|SUPERIORITY||Mean Difference (Net)|0.1|STANDARD_DEVIATION|4.5||0.445|ONE_SIDED|90.0|-1.1|||a priori threshold for statistical significance=0.1 for 1-sided t-test; no adjustments for multiple comparisons made; if the outcome is not in the hypothesized direction, values that meet or exceed the 0.1 threshold will not be considered significant|t-test, 1 sided||||||-1.1|0.445
72561412|NCT01525628|144653435|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 17 vs. Day 9 (%)|450.51|STANDARD_DEVIATION|48.0||1|TWO_SIDED|90.0|343.67|590.57|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of BI CD 6168 at Day 17 vs. Day 9 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 17 vs. Day 9||590.57|343.67|1.0000
72447597|NCT03858634|144412940|SUPERIORITY||LS mean difference|-32.7|STANDARD_ERROR_OF_MEAN|41.95||0.4927|TWO_SIDED|80.0|-101.39|36.02||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 5||36.02|-101.39|0.4927
72447598|NCT03858634|144412940|SUPERIORITY||LS mean difference|-10.9|STANDARD_ERROR_OF_MEAN|13.9||0.4409|TWO_SIDED|80.0|-29.35|7.49||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 5||7.49|-29.35|0.4409
72447599|NCT03858634|144412940|SUPERIORITY||LS mean difference|-90.7|STANDARD_ERROR_OF_MEAN|34.58||0.1197|TWO_SIDED|80.0|-155.96|-25.54||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 5||-25.54|-155.96|0.1197
72447600|NCT03858634|144412940|SUPERIORITY||LS mean difference|-35.3|STANDARD_ERROR_OF_MEAN|12.31||0.0102|TWO_SIDED|80.0|-51.68|-18.92||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANOVA|||Change at Week 5||-18.92|-51.68|0.0102
72447601|NCT03858634|144412940|SUPERIORITY||LS mean difference|-33.5|STANDARD_ERROR_OF_MEAN|38.77||0.4515|TWO_SIDED|80.0|-96.97|30.02||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 6||30.02|-96.97|0.4515
72447602|NCT03858634|144412940|SUPERIORITY||LS mean difference|-4.5|STANDARD_ERROR_OF_MEAN|14.56||0.7623|TWO_SIDED|80.0|-23.76|14.83||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 6||14.83|-23.76|0.7623
72447603|NCT03858634|144412940|SUPERIORITY||LS mean difference|-88.5|STANDARD_ERROR_OF_MEAN|34.57||0.1247|TWO_SIDED|80.0|-153.65|-23.29||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 6||-23.29|-153.65|0.1247
72447604|NCT03858634|144412940|SUPERIORITY||LS mean difference|-37.7|STANDARD_ERROR_OF_MEAN|11.91||0.0053|TWO_SIDED|80.0|-53.59|-21.9||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 6||-21.90|-53.59|0.0053
72447605|NCT03858634|144412940|SUPERIORITY||LS mean difference|-17.2|STANDARD_ERROR_OF_MEAN|43.23||0.7177|TWO_SIDED|80.0|-87.97|53.62||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 7||53.62|-87.97|0.7177
72447606|NCT03858634|144412940|SUPERIORITY||LS mean difference|-6.2|STANDARD_ERROR_OF_MEAN|14.35||0.6682|TWO_SIDED|80.0|-25.26|12.78||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 7||12.78|-25.26|0.6682
72447607|NCT03858634|144412940|SUPERIORITY||LS mean difference|-95.2|STANDARD_ERROR_OF_MEAN|29.16||0.0823|TWO_SIDED|80.0|-150.21|-40.24||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 7||-40.24|-150.21|0.0823
72447608|NCT03858634|144412940|SUPERIORITY||LS mean difference|-38.1|STANDARD_ERROR_OF_MEAN|12.95||0.0087|TWO_SIDED|80.0|-55.38|-20.92||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 7||-20.92|-55.38|0.0087
72447609|NCT03858634|144412940|SUPERIORITY||LS mean difference|-31.7|STANDARD_ERROR_OF_MEAN|38.73||0.4734|TWO_SIDED|80.0|-95.11|31.76||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 8||31.76|-95.11|0.4734
72447610|NCT03858634|144412940|SUPERIORITY||LS mean difference|-3.6|STANDARD_ERROR_OF_MEAN|14.91||0.813|TWO_SIDED|80.0|-23.33|16.18||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 8||16.18|-23.33|0.8130
72447611|NCT03858634|144412940|SUPERIORITY||LS mean difference|-92.0|STANDARD_ERROR_OF_MEAN|31.1||0.0979|TWO_SIDED|80.0|-150.6|-33.32||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 8||-33.32|-150.60|0.0979
72447612|NCT03858634|144412940|SUPERIORITY||LS mean difference|-37.5|STANDARD_ERROR_OF_MEAN|13.48||0.0122|TWO_SIDED|80.0|-55.48|-19.61||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 8||-19.61|-55.48|0.0122
72447613|NCT03858634|144412940|SUPERIORITY||LS mean difference|-32.1|STANDARD_ERROR_OF_MEAN|35.35||0.431|TWO_SIDED|80.0|-89.98|25.81||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 9||25.81|-89.98|0.4310
72447614|NCT03858634|144412940|SUPERIORITY||LS mean difference|-7.1|STANDARD_ERROR_OF_MEAN|15.22||0.6452|TWO_SIDED|80.0|-27.38|13.12||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 9||13.12|-27.38|0.6452
72447615|NCT03858634|144412940|SUPERIORITY||LS mean difference|-89.2|STANDARD_ERROR_OF_MEAN|37.02||0.1375|TWO_SIDED|80.0|-159.04|-19.44||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 9||-19.44|-159.04|0.1375
72447616|NCT03858634|144412940|SUPERIORITY||LS mean difference|-39.6|STANDARD_ERROR_OF_MEAN|14.59||0.0143|TWO_SIDED|80.0|-58.97|-20.15||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 9||-20.15|-58.97|0.0143
72447617|NCT03858634|144412940|SUPERIORITY||LS mean difference|-22.1|STANDARD_ERROR_OF_MEAN|36.4||0.5867|TWO_SIDED|80.0|-81.7|37.52||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 10||37.52|-81.70|0.5867
72447618|NCT03858634|144412940|SUPERIORITY||LS mean difference|6.1|STANDARD_ERROR_OF_MEAN|14.38||0.6745|TWO_SIDED|80.0|-12.99|25.27||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 10||25.27|-12.99|0.6745
72447619|NCT03858634|144412940|SUPERIORITY||LS mean difference|-85.6|STANDARD_ERROR_OF_MEAN|29.99||0.1039|TWO_SIDED|80.0|-142.18|-29.09||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 10||-29.09|-142.18|0.1039
72447620|NCT03858634|144412940|SUPERIORITY||LS mean difference|-42.5|STANDARD_ERROR_OF_MEAN|15.12||0.0116|TWO_SIDED|80.0|-62.6|-22.36||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 10||-22.36|-62.60|0.0116
72447621|NCT03858634|144412940|SUPERIORITY||LS mean difference|-23.1|STANDARD_ERROR_OF_MEAN|37.49||0.5807|TWO_SIDED|80.0|-84.55|38.26||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 11||38.26|-84.55|0.5807
72498327|NCT03417440|144527031|SUPERIORITY||Mean Difference (Net)|-1.3|STANDARD_DEVIATION|4.4||0.92|ONE_SIDED|90.0|-2.5|||a priori threshold for statistical significance=0.1 for 1-sided t-test; no adjustments for multiple comparisons made; if the outcome is not in the hypothesized direction, values that meet or exceed the 0.1 threshold will not be considered significant|t-test, 1 sided||||||-2.5|0.92
72447622|NCT03858634|144412940|SUPERIORITY||LS mean difference|8.6|STANDARD_ERROR_OF_MEAN|15.16||0.5765|TWO_SIDED|80.0|-11.55|28.8||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 11||28.80|-11.55|0.5765
72447623|NCT03858634|144412940|SUPERIORITY||LS mean difference|-86.2|STANDARD_ERROR_OF_MEAN|28.36||0.0933|TWO_SIDED|80.0|-139.7|-32.75||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 11||-32.75|-139.70|0.0933
72561413|NCT01525628|144653435|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 66 vs. Day 9 (%)|341.96|STANDARD_DEVIATION|61.1||0.9996|TWO_SIDED|90.0|229.22|510.13|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of BI CD 6168 at Day 66 vs. Day 9 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 66 vs. Day 9||510.13|229.22|0.9996
72447624|NCT03858634|144412940|SUPERIORITY||LS mean difference|-39.3||||0.0173|TWO_SIDED|80.0|-59.29|-19.37||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 11||-19.37|-59.29|0.0173
72447625|NCT03858634|144412940|SUPERIORITY||LS mean difference|-27.2|STANDARD_ERROR_OF_MEAN|38.36||0.5293|TWO_SIDED|80.0|-90.04|35.62||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 12||35.62|-90.04|0.5293
72447626|NCT03858634|144412940|SUPERIORITY||LS mean difference|-0.6|STANDARD_ERROR_OF_MEAN|15.12||0.9676|TWO_SIDED|80.0|-20.73|19.49||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 12||19.49|-20.73|0.9676
72447627|NCT03858634|144412940|SUPERIORITY||LS mean difference|-86.2|STANDARD_ERROR_OF_MEAN|23.38||0.0663|TWO_SIDED|80.0|-130.27|-42.11||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 12||-42.11|-130.27|0.0663
72447628|NCT03858634|144412940|SUPERIORITY||LS mean difference|-37.4|STANDARD_ERROR_OF_MEAN|15.33||0.0252|TWO_SIDED|80.0|-57.81|-17.02||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 12||-17.02|-57.81|0.0252
72447629|NCT03858634|144412940|SUPERIORITY||LS mean difference|-19.6|STANDARD_ERROR_OF_MEAN|40.81||0.6637|TWO_SIDED|80.0|-86.45|47.22||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 13||47.22|-86.45|0.6637
72447630|NCT03858634|144412940|SUPERIORITY||LS mean difference|-1.6|STANDARD_DEVIATION|15.35||0.9173|TWO_SIDED|80.0|-22.04|18.81||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 13||18.81|-22.04|0.9173
72447631|NCT03858634|144412940|SUPERIORITY||LS mean difference|-96.2|STANDARD_ERROR_OF_MEAN|26.55||0.0685|TWO_SIDED|80.0|-146.23|-46.1||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 13||-46.10|-146.23|0.0685
72447632|NCT03858634|144412940|SUPERIORITY||LS mean difference|-39.7|STANDARD_ERROR_OF_MEAN|15.96||0.023|TWO_SIDED|80.0|-60.91|-18.44||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 13||-18.44|-60.91|0.0230
72447633|NCT03858634|144412940|SUPERIORITY||LS mean difference|-19.1|STANDARD_ERROR_OF_MEAN|37.62||0.6471|TWO_SIDED|80.0|-80.69|42.54||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 14||42.54|-80.69|0.6471
72498328|NCT03417440|144527031|SUPERIORITY||Mean Difference (Net)|0.7|STANDARD_DEVIATION|4.5||0.23|ONE_SIDED|90.0|-0.5|||a priori threshold for statistical significance=0.1 for 1-sided t-test; no adjustments for multiple comparisons made; if the outcome is not in the hypothesized direction, values that meet or exceed the 0.1 threshold will not be considered significant|t-test, 1 sided||||||-0.5|0.23
72498329|NCT03417440|144527032|SUPERIORITY||Mean Difference (Net)|-0.2|STANDARD_DEVIATION|1.1||0.78|ONE_SIDED|90.0|-0.5|||a priori threshold for statistical significance=0.1 for 1-sided t-test; no adjustments for multiple comparisons made; if the outcome is not in the hypothesized direction, values that meet or exceed the 0.1 threshold will not be considered significant|t-test, 1 sided||||||-0.5|0.78
72498330|NCT03417440|144527032|SUPERIORITY||Mean Difference (Net)|-0.4|STANDARD_DEVIATION|1.1||0.98|ONE_SIDED|90.0|-0.7|||a priori threshold for statistical significance=0.1 for 1-sided t-test; no adjustments for multiple comparisons made; if the outcome is not in the hypothesized direction, values that meet or exceed the 0.1 threshold will not be considered significant|t-test, 1 sided||||||-0.7|0.98
72561414|NCT01525628|144653436|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 17 vs. Day 9 (%)|466.92|STANDARD_DEVIATION|47.6||1|TWO_SIDED|90.0|357.02|610.66|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of BI CD 6168 at Day 17 vs. Day 9 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 17 vs. Day 9||610.66|357.02|1.0000
72561415|NCT01525628|144653436|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 66 vs. Day 9 (%)|298.57|STANDARD_DEVIATION|79.2||0.9972|TWO_SIDED|90.0|187.22|476.15|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of BI CD 6168 at Day 66 vs. Day 9 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 66 vs. Day 9||476.15|187.22|0.9972
72561416|NCT01525628|144653437|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 17 vs. Day 9 (%)|528.95|STANDARD_DEVIATION|42.0||1|TWO_SIDED|90.0|415.88|672.75|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of BI CD 6168-ag at Day 17 vs. Day 9 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 17 vs. Day 9||672.75|415.88|1.0000
72561417|NCT01525628|144653437|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 66 vs. Day 9 (%)|384.0|STANDARD_DEVIATION|69.2||0.9998|TWO_SIDED|90.0|251.56|586.16|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of BI CD 6168-ag at Day 66 vs. Day 9 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 66 vs. Day 9||586.16|251.56|0.9998
72561418|NCT01525628|144653438|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 17 vs. Day 9 (%)|569.81|STANDARD_DEVIATION|42.2||1|TWO_SIDED|90.0|447.49|725.57|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of BI CD 6168-ag at Day 17 vs. Day 9 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 17 vs. Day 9||725.57|447.49|1.0000
72561419|NCT01525628|144653438|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 66 vs. Day 9 (%)|441.89|STANDARD_DEVIATION|66.9||0.9999|TWO_SIDED|90.0|286.81|680.82|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of BI CD 6168-ag at Day 66 vs. Day 9 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 66 vs. Day 9||680.82|286.81|0.9999
72390534|NCT03535844|144288711|SUPERIORITY|||||||0.7052|||||||t-test, 2 sided|Independent t-test of change values||||||0.7052
72390535|NCT03535844|144288711|SUPERIORITY|||||||0.07|||||||t-test, 2 sided|Paired t-test between Week 0 and Week 16 endothelin-1 concentrations||||||0.07
72390536|NCT03535844|144288711|SUPERIORITY|||||||0.005||||||Paired t-test between Week 0 and Week 16 endothelin-1 concentrations|t-test, 2 sided|||||||0.005
72390537|NCT03535844|144288712|SUPERIORITY|||||||0.9426||||||Independent t-test of change values|t-test, 2 sided|||||||0.9426
72390538|NCT03600818|144288747|SUPERIORITY||Difference in percentage|18.0|||=|0.0193|TWO_SIDED|95.0|4.15|31.82||Threshold for significance at 0.05 level.|Fisher Exact|||||31.82|4.15|=0.0193
72390539|NCT03600818|144288748|SUPERIORITY||||||<|0.0001||||||Threshold for significance at 0.05 level.|Wilcoxon rank-sum test|||A hierarchical testing procedure was used to control the overall type I error. If the primary endpoint reaches statistical significance then the secondary endpoint for total cumulative CS dose was tested next.||||<0.0001
72390540|NCT03416946|144288771|SUPERIORITY|||||||0.79||||||Post-op HKA angle|t-test, 2 sided|||||||0.790
72390541|NCT01112865|144288802|SUPERIORITY_OR_OTHER|||||||0.6858|TWO_SIDED|||||Binomial test against the null hypothesis|binomial test|||Null hypothesis: percentage of participants preferring Genotropin Mark VII injection pen = 50%||||0.6858
72447634|NCT03858634|144412940|SUPERIORITY||LS mean difference|-3.9|STANDARD_ERROR_OF_MEAN|15.52||0.8044|TWO_SIDED|80.0|-24.56|16.75||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 14||16.75|-24.56|0.8044
72447635|NCT03858634|144412940|SUPERIORITY||LS mean difference|-99.5|STANDARD_ERROR_OF_MEAN|28.71||0.0741|TWO_SIDED|80.0|-153.63|-45.37||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 14||-45.37|-153.63|0.0741
72447636|NCT03858634|144412940|SUPERIORITY||LS mean difference|-39.9|STANDARD_ERROR_OF_MEAN|15.89||0.0219|TWO_SIDED|80.0|-61.0|-18.72||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 14||-18.72|-61.00|0.0219
72447637|NCT03858634|144412940|SUPERIORITY||LS mean difference|-25.4|STANDARD_ERROR_OF_MEAN|37.15||0.5436|TWO_SIDED|80.0|-86.21|35.46||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 15||35.46|-86.21|0.5436
72447638|NCT03858634|144412940|SUPERIORITY||LS mean difference|-1.7|STANDARD_ERROR_OF_MEAN|16.13||0.9149|TWO_SIDED|80.0|-23.2|19.71||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 15||19.71|-23.20|0.9149
72447639|NCT03858634|144412940|SUPERIORITY||LS mean difference|-94.8|STANDARD_ERROR_OF_MEAN|25.34||0.0646|TWO_SIDED|80.0|-142.63|-47.05||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 15||-47.05|-142.63|0.0646
72447640|NCT03858634|144412940|SUPERIORITY||LS mean difference|-34.2|STANDARD_ERROR_OF_MEAN|17.09||0.0611|TWO_SIDED|80.0|-56.89|-11.41||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 15||-11.41|-56.89|0.0611
72447641|NCT03858634|144412940|SUPERIORITY||LS mean difference|-22.0|STANDARD_ERROR_OF_MEAN|38.28||0.606|TWO_SIDED|80.0|-84.68|40.71||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 16||40.71|-84.68|0.6060
72447642|NCT03858634|144412940|SUPERIORITY||LS mean difference|-6.9|STANDARD_ERROR_OF_MEAN|16.61||0.6823|TWO_SIDED|80.0|-29.0|15.18||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 16||15.18|-29.00|0.6823
72447643|NCT03858634|144412940|SUPERIORITY||LS mean difference|-99.7|STANDARD_ERROR_OF_MEAN|24.56||0.0556|TWO_SIDED|80.0|-146.02|-53.41||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 16||-53.41|-146.02|0.0556
72498331|NCT03417440|144527032|SUPERIORITY||Mean Difference (Net)|0.2|STANDARD_DEVIATION|1.1||0.13|ONE_SIDED|90.0|-0.1|||a priori threshold for statistical significance=0.1 for 1-sided t-test; no adjustments for multiple comparisons made; if the outcome is not in the hypothesized direction, values that meet or exceed the 0.1 threshold will not be considered significant|t-test, 1 sided||||||-0.1|0.13
72561420|NCT01525628|144653439|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 17 vs. Day 9 (%)|606.29|STANDARD_DEVIATION|44.2||1|TWO_SIDED|90.0|471.42|779.74|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of BI CD 6168-ag at Day 17 vs. Day 9 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 17 vs. Day 9||779.74|471.42|1.0000
72561421|NCT01525628|144653439|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 66 vs. Day 9 (%)|377.98|STANDARD_DEVIATION|82.0||0.9994|TWO_SIDED|90.0|233.48|611.91|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of BI CD 6168-ag at Day 66 vs. Day 9 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 66 vs. Day 9||611.91|233.48|0.9994
72561422|NCT01525628|144653440|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 9 vs. Day 1 (%)|97.03|STANDARD_DEVIATION|30.8||0.05|TWO_SIDED|90.0|80.0|117.69|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of caffeine at Day 9 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 9 vs. Day 1||117.69|80.00|0.0500
72619396|NCT00098293|144769636|SUPERIORITY_OR_OTHER||Difference in Percentage|-0.2|||||ONE_SIDED|97.5|-7.4|||||||Less than 50 copies/mL: Treatment difference in percentage stratified by randomization strata was presented along with the lower bound of the 1-sided 97.5% CI based on the normal approximation to the binomial distribution. Positive value would favor maraviroc. Due to its post-hoc nature, this analysis was considered descriptive only rather than inferential.|||-7.4|
72619397|NCT00098293|144769637|SUPERIORITY_OR_OTHER||Difference in Percentage|-0.4|||||ONE_SIDED|97.5|-7.9|||||||Less than 400 copies/mL: Treatment difference in percentage stratified by randomization strata was presented along with the lower bound of the 1-sided 97.5% CI based on the normal approximation to the binomial distribution. Positive value would favor maraviroc. Due to its post-hoc nature, this analysis was considered descriptive only rather than inferential.|||-7.9|
72447644|NCT03858634|144412940|SUPERIORITY||LS mean difference|-33.4|STANDARD_ERROR_OF_MEAN|16.99||0.0652|TWO_SIDED|80.0|-55.98|-10.76||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 16||-10.76|-55.98|0.0652
72447645|NCT03858634|144412940|SUPERIORITY||LS mean difference|-26.3|STANDARD_ERROR_OF_MEAN|41.45||0.5714|TWO_SIDED|80.0|-94.14|41.62||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 17||41.62|-94.14|0.5714
72447646|NCT03858634|144412940|OTHER||LS mean difference|-10.5|STANDARD_ERROR_OF_MEAN|16.82||0.5386|TWO_SIDED|80.0|-32.93|11.83||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 17||11.83|-32.93|0.5386
72447647|NCT03858634|144412940|SUPERIORITY||LS mean difference|-99.0|STANDARD_ERROR_OF_MEAN|21.41||0.0438|TWO_SIDED|80.0|-139.35|-58.6||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 17||-58.60|-139.35|0.0438
72447648|NCT03858634|144412940|OTHER||LS mean difference|-27.2|STANDARD_ERROR_OF_MEAN|19.66||0.1829|TWO_SIDED|80.0|-53.38|-1.08||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 17||-1.08|-53.38|0.1829
72447649|NCT03858634|144412940|SUPERIORITY||LS mean difference|-25.6|STANDARD_ERROR_OF_MEAN|37.59||0.5443|TWO_SIDED|80.0|-87.2|35.94||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 18||35.94|-87.20|0.5443
72447650|NCT03858634|144412940|SUPERIORITY||LS mean difference|-7.9|STANDARD_ERROR_OF_MEAN|18.43||0.6748|TWO_SIDED|80.0|-32.39|16.66||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 18||16.66|-32.39|0.6748
72447651|NCT03858634|144412940|SUPERIORITY||LS mean difference|-96.2|STANDARD_ERROR_OF_MEAN|16.97||0.0297|TWO_SIDED|80.0|-128.19|-64.19||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 18||-64.19|-128.19|0.0297
72447652|NCT03858634|144412940|SUPERIORITY||LS mean difference|-27.0|STANDARD_ERROR_OF_MEAN|19.8||0.1899|TWO_SIDED|80.0|-53.33|-0.63||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 18||-0.63|-53.33|0.1899
72447653|NCT03858634|144412942|SUPERIORITY||LS mean difference|-15.3|STANDARD_ERROR_OF_MEAN|24.47||0.5763|TWO_SIDED|80.0|-55.37|24.78||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 1||24.78|-55.37|0.5763
72447654|NCT03858634|144412942|SUPERIORITY||LS mean difference|9.6|STANDARD_ERROR_OF_MEAN|14.66||0.5214|TWO_SIDED|80.0|-9.86|29.01||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 1||29.01|-9.86|0.5214
72447655|NCT03858634|144412942|SUPERIORITY||LS mean difference|-167.0|STANDARD_ERROR_OF_MEAN|105.28||0.2536|TWO_SIDED|80.0|-365.51|31.54||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 1||31.54|-365.51|0.2536
72447656|NCT03858634|144412942|SUPERIORITY||LS mean difference|-10.8|STANDARD_ERROR_OF_MEAN|5.55||0.067|TWO_SIDED|80.0|-18.2|-3.44||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 1||-3.44|-18.20|0.0670
72447657|NCT03858634|144412942|SUPERIORITY||LS mean difference|-33.1|STANDARD_ERROR_OF_MEAN|34.98||0.4133|TWO_SIDED|80.0|-90.43|24.15||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 2||24.15|-90.43|0.4133
72447658|NCT03858634|144412942|SUPERIORITY||LS mean difference|-1.4|STANDARD_ERROR_OF_MEAN|15.44||0.9305|TWO_SIDED|80.0|-21.83|19.11|||ANCOVA|||Change at Week 2||19.11|-21.83|0.9305
72447659|NCT03858634|144412942|SUPERIORITY||LS mean difference|-160.9|STANDARD_ERROR_OF_MEAN|132.98||0.3499|TWO_SIDED|80.0|-411.65|89.86||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 2||89.86|-411.65|0.3499
72447660|NCT03858634|144412942|SUPERIORITY||LS mean difference|-14.0|STANDARD_ERROR_OF_MEAN|9.55||0.1588|TWO_SIDED|80.0|-26.74|-1.33||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 2||-1.33|-26.74|0.1588
72447661|NCT03858634|144412942|SUPERIORITY||LS mean difference|-40.6|STANDARD_ERROR_OF_MEAN|35.19||0.3319|TWO_SIDED|80.0|-98.26|17.0||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 3||17.00|-98.26|0.3319
72447662|NCT03858634|144412942|SUPERIORITY||LS mean difference|7.1|STANDARD_ERROR_OF_MEAN|19.39||0.7179|TWO_SIDED|80.0|-18.59|32.8||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 3||32.80|-18.59|0.7179
72447663|NCT03858634|144412942|SUPERIORITY||LS mean difference|-193.8|STANDARD_ERROR_OF_MEAN|112.17||0.2261|TWO_SIDED|80.0|-405.34|17.67||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 3||17.67|-405.34|0.2261
72447664|NCT03858634|144412942|SUPERIORITY||LS mean difference|-30.3|STANDARD_ERROR_OF_MEAN|10.88||0.0123|TWO_SIDED|80.0|-44.75|-15.8||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 3||-15.80|-44.75|0.0123
72447665|NCT03858634|144412942|SUPERIORITY||LS mean difference|-54.0|STANDARD_ERROR_OF_MEAN|35.45||0.2253|TWO_SIDED|80.0|-112.02|4.09||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 4||4.09|-112.02|0.2253
72447666|NCT03858634|144412942|SUPERIORITY||LS mean difference|6.3|STANDARD_ERROR_OF_MEAN|16.9||0.7149|TWO_SIDED|80.0|-16.14|28.66||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 4||28.66|-16.14|0.7149
72561423|NCT01525628|144653440|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 17 vs. Day 1 (%)|97.1|STANDARD_DEVIATION|31.2||0.0564|TWO_SIDED|90.0|79.37|118.79|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of caffeine at Day 17 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 17 vs. Day 1||118.79|79.37|0.0564
72447667|NCT03858634|144412942|SUPERIORITY||LS mean difference|-168.4|STANDARD_ERROR_OF_MEAN|109.12||0.2627|TWO_SIDED|80.0|-374.16|37.36||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 4||37.36|-374.16|0.2627
72561424|NCT01525628|144653440|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 66 vs. Day 1 (%)|114.38|STANDARD_DEVIATION|31.9||0.2375|TWO_SIDED|90.0|92.36|141.66|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of caffeine at Day 66 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 66 vs. Day 1||141.66|92.36|0.2375
72561425|NCT01525628|144653440|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 9 vs. Day 1 (%)|139.07|STANDARD_DEVIATION|22.8||0.9082|TWO_SIDED|90.0|121.63|159.0|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of caffeine at Day 9 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 9 vs. Day 1||159.00|121.63|0.9082
72447668|NCT03858634|144412942|SUPERIORITY||LS mean difference|-36.7|STANDARD_ERROR_OF_MEAN|11.38||0.0047|TWO_SIDED|80.0|-51.87|-21.6||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 4||-21.60|-51.87|0.0047
72561426|NCT01525628|144653440|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 17 vs. Day 1 (%)|122.37|STANDARD_DEVIATION|29.3||0.4111|TWO_SIDED|90.0|104.11|143.84|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of caffeine at Day 17 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 17 vs. Day 1||143.84|104.11|0.4111
72561427|NCT01525628|144653440|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 66 vs. Day 1 (%)|121.43|STANDARD_DEVIATION|24.7||0.3719|TWO_SIDED|90.0|104.24|141.45|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of caffeine at Day 66 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 66 vs. Day 1||141.45|104.24|0.3719
72561428|NCT01525628|144653441|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 9 vs. Day 1 (%)|88.37|STANDARD_DEVIATION|20.8||0.1037|TWO_SIDED|90.0|77.39|100.89|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of caffeine at Day 9 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 9 vs. Day 1||100.89|77.39|0.1037
72561429|NCT01525628|144653441|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 17 vs. Day 1 (%)|159.11|STANDARD_DEVIATION|57.8||0.8723|TWO_SIDED|90.0|111.06|227.93|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of caffeine at Day 17 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 17 vs. Day 1||227.93|111.06|0.8723
72561430|NCT01525628|144653441|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 66 vs. Day 1 (%)|259.57|STANDARD_DEVIATION|92.5||0.983|TWO_SIDED|90.0|150.65|447.21|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of caffeine at Day 66 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 66 vs. Day 1||447.21|150.65|0.9830
72561431|NCT01525628|144653441|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 9 vs. Day 1 (%)|163.95|STANDARD_DEVIATION|38.1||0.9689|TWO_SIDED|90.0|129.52|207.52|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of caffeine at Day 9 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 9 vs. Day 1||207.52|129.52|0.9689
72561432|NCT01525628|144653441|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 17 vs. Day 1 (%)|219.88|STANDARD_DEVIATION|70.4||0.9933|TWO_SIDED|90.0|153.84|314.26|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of caffeine at Day 17 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 17 vs. Day 1||314.26|153.84|0.9933
72561433|NCT01525628|144653441|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 66 vs. Day 1 (%)|214.4|STANDARD_DEVIATION|66.8||0.9865|TWO_SIDED|90.0|145.88|315.09|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of caffeine at Day 66 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 66 vs. Day 1||315.09|145.88|0.9865
72561434|NCT01525628|144653442|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 9 vs. Day 1 (%)|96.06|STANDARD_DEVIATION|14.2||0.0015|TWO_SIDED|90.0|87.77|105.13|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of tolbutamide at Day 9 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 9 vs. Day 1||105.13|87.77|0.0015
72561435|NCT01525628|144653442|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 17 vs. Day 1 (%)|85.41|STANDARD_DEVIATION|17.2||0.1617|TWO_SIDED|90.0|76.32|95.57|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of tolbutamide at Day 17 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 17 vs. Day 1||95.57|76.32|0.1617
72619398|NCT00098293|144769637|SUPERIORITY_OR_OTHER||Difference in Percentage|-3.9|||||ONE_SIDED|97.5|-11.5|||||||Less than 50 copies/mL: Treatment difference in percentage stratified by randomization strata was presented along with the lower bound of the 1-sided 97.5% CI based on the normal approximation to the binomial distribution. Positive value would favor maraviroc. Due to its post-hoc nature, this analysis was considered descriptive only rather than inferential.|||-11.5|
72619399|NCT01370642|144769638|SUPERIORITY_OR_OTHER||Adjusted Difference in Percentages|29.0|||<|0.001|TWO_SIDED|95.0|17.2|40.5|||Miettinen and Nurminen method|||To compare the percentage of participants achieving SVR24 between the vaniprevir and control arms, 95% confidence intervals and corresponding p-values for the between-treatment difference (vaniprevir - control) were computed using Miettinen and Nurminen method stratified by Interleukin 28B (IL28B) and age utilizing Cochran-Mantel-Haenszel weights.||40.5|17.2|<0.001
72561436|NCT01525628|144653442|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 66 vs. Day 1 (%)|73.26|STANDARD_DEVIATION|17.5||0.893|TWO_SIDED|90.0|65.03|82.54|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of tolbutamide at Day 66 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 66 vs. Day 1||82.54|65.03|0.8930
72447669|NCT03858634|144412942|SUPERIORITY||LS mean difference|-66.1|STANDARD_ERROR_OF_MEAN|38.01||0.1803|TWO_SIDED|80.0|-128.37|-3.88||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 5||-3.88|-128.37|0.1803
72447670|NCT03858634|144412942|SUPERIORITY||LS mean difference|6.4|STANDARD_ERROR_OF_MEAN|17.34||0.7174|TWO_SIDED|80.0|-16.62|29.35||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 5||29.35|-16.62|0.7174
72447671|NCT03858634|144412942|SUPERIORITY||LS mean difference|-163.4|STANDARD_ERROR_OF_MEAN|103.47||0.2551|TWO_SIDED|80.0|-358.51|31.72||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 5||31.72|-358.51|0.2551
72447672|NCT03858634|144412942|SUPERIORITY||LS mean difference|-33.5|STANDARD_ERROR_OF_MEAN|11.36||0.0086|TWO_SIDED|80.0|-48.58|-18.36||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 5||-18.36|-48.58|0.0086
72447673|NCT03858634|144412942|SUPERIORITY||LS mean difference|-56.0|STANDARD_ERROR_OF_MEAN|40.16||0.2576|TWO_SIDED|80.0|-121.78|9.78||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 6||9.78|-121.78|0.2576
72447674|NCT03858634|144412942|SUPERIORITY||LS mean difference|-0.6|STANDARD_ERROR_OF_MEAN|18.09||0.9722|TWO_SIDED|80.0|-24.62|23.34||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 6||23.34|-24.62|0.9722
72447675|NCT03858634|144412942|SUPERIORITY||LS mean difference|-177.4|STANDARD_ERROR_OF_MEAN|95.72||0.2051|TWO_SIDED|80.0|-357.85|3.13||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 6||3.13|-357.85|0.2051
72447676|NCT03858634|144412942|SUPERIORITY||LS mean difference|-42.0|STANDARD_ERROR_OF_MEAN|11.99||0.0025|TWO_SIDED|80.0|-57.98|-26.08||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 6||-26.08|-57.98|0.0025
72447677|NCT03858634|144412942|SUPERIORITY||LS mean difference|-65.8|STANDARD_ERROR_OF_MEAN|33.78||0.1465|TWO_SIDED|80.0|-121.14|-10.5||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 7||-10.50|-121.14|0.1465
72447678|NCT03858634|144412942|SUPERIORITY||LS mean difference|5.1|STANDARD_ERROR_OF_MEAN|17.54||0.7734|TWO_SIDED|80.0|-18.13|28.37||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 7||28.37|-18.13|0.7734
72447679|NCT03858634|144412942|SUPERIORITY||LS mean difference|-175.5|STANDARD_ERROR_OF_MEAN|87.45||0.1826|TWO_SIDED|80.0|-340.37|-10.56||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 7||-10.56|-340.37|0.1826
72447680|NCT03858634|144412942|SUPERIORITY||LS mean difference|-39.2|STANDARD_ERROR_OF_MEAN|13.71||0.0105|TWO_SIDED|80.0|-57.4|-20.93||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 7||-20.93|-57.40|0.0105
72447681|NCT03858634|144412942|SUPERIORITY||LS mean difference|-53.7|STANDARD_ERROR_OF_MEAN|40.17||0.2737|TWO_SIDED|80.0|-119.49|12.09||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 8||12.09|-119.49|0.2737
72447682|NCT03858634|144412942|SUPERIORITY||LS mean difference|3.0|STANDARD_ERROR_OF_MEAN|17.77||0.8692|TWO_SIDED|80.0|-20.59|26.52||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 8||26.52|-20.59|0.8692
72447683|NCT03858634|144412942|SUPERIORITY||LS mean difference|-163.0|STANDARD_ERROR_OF_MEAN|89.64||0.2106|TWO_SIDED|80.0|-332.06|5.99||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 8||5.99|-332.06|0.2106
72447684|NCT03858634|144412942|SUPERIORITY||LS mean difference|-45.7|STANDARD_ERROR_OF_MEAN|14.67||0.006|TWO_SIDED|80.0|-65.19|-26.14||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 8||-26.14|-65.19|0.0060
72447685|NCT03858634|144412942|SUPERIORITY||LS mean difference|-62.3|STANDARD_ERROR_OF_MEAN|36.12||0.1831|TWO_SIDED|80.0|-121.44|-3.13||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 10||-3.13|-121.44|0.1831
72447686|NCT03858634|144412942|SUPERIORITY||LS mean difference|21.5|STANDARD_ERROR_OF_MEAN|16.39||0.2061|TWO_SIDED|80.0|-0.31|43.3||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 10||43.30|-0.31|0.2061
72447687|NCT03858634|144412942|SUPERIORITY||LS mean difference|-161.4|STANDARD_ERROR_OF_MEAN|87.75||0.2073|TWO_SIDED|80.0|-326.83|4.12||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 10||4.12|-326.83|0.2073
72447688|NCT03858634|144412942|SUPERIORITY||LS mean difference|-34.4|STANDARD_ERROR_OF_MEAN|15.19||0.0371|TWO_SIDED|80.0|-54.62|-14.1||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 10||-14.10|-54.62|0.0371
72447689|NCT03858634|144412942|SUPERIORITY||LS mean difference|-55.2|STANDARD_ERROR_OF_MEAN|37.72||0.2393|TWO_SIDED|80.0|-117.01|6.54||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 12||6.54|-117.01|0.2393
72498332|NCT03417440|144527033|SUPERIORITY||Mean Difference (Net)|-0.5|STANDARD_DEVIATION|4.3||0.285|ONE_SIDED|90.0||0.6||a priori threshold for statistical significance=0.1 for 1-sided t-test; no adjustments for multiple comparisons made; if the outcome is not in the hypothesized direction, values that meet or exceed the 0.1 threshold will not be considered significant|t-test, 1 sided|||||0.6||0.285
72561437|NCT01525628|144653442|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 9 vs. Day 1 (%)|92.23|STANDARD_DEVIATION|10.5||0.0005|TWO_SIDED|90.0|86.67|98.13|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of tolbutamide at Day 9 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 9 vs. Day 1||98.13|86.67|0.0005
72561438|NCT01525628|144653442|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 17 vs. Day 1 (%)|73.93|STANDARD_DEVIATION|21.6||0.8646|TWO_SIDED|90.0|65.55|83.39|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of tolbutamide at Day 17 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 17 vs. Day 1||83.39|65.55|0.8646
72561439|NCT01525628|144653442|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 66 vs. Day 1 (%)|75.42|STANDARD_DEVIATION|16.4||0.8378|TWO_SIDED|90.0|68.15|83.45|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of tolbutamide at Day 66 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 66 vs. Day 1||83.45|68.15|0.8378
72561440|NCT01525628|144653443|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 9 vs. Day 1 (%)|98.17|STANDARD_DEVIATION|12.3||0.0005|TWO_SIDED|90.0|90.15|106.91|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of tolbutamide at Day 9 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 9 vs. Day 1||106.91|90.15|0.0005
72561441|NCT01525628|144653443|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 17 vs. Day 1 (%)|81.26|STANDARD_DEVIATION|11.7||0.3638|TWO_SIDED|90.0|75.19|87.82|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of tolbutamide at Day 17 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 17 vs. Day 1||87.82|75.19|0.3638
72561442|NCT01525628|144653443|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 66 vs. Day 1 (%)|70.93|STANDARD_DEVIATION|22.6||0.8975|TWO_SIDED|90.0|60.44|83.22|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of tolbutamide at Day 66 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 66 vs. Day 1||83.22|60.44|0.8975
72619400|NCT01370642|144769638|SUPERIORITY_OR_OTHER||Adjusted Difference in Percentages|28.6|||<|0.001|TWO_SIDED|95.0|17.4|40.0|||Miettinen and Nurminen method|||To compare the percentage of participants achieving SVR24 between the vaniprevir and control arms, 95% confidence intervals and corresponding p-values for the between-treatment difference (vaniprevir - control) were computed using Miettinen and Nurminen method stratified by IL28B and age utilizing Cochran-Mantel-Haenszel weights.||40.0|17.4|<0.001
72619401|NCT01370642|144769639|SUPERIORITY_OR_OTHER||Adjusted Difference in Percentages|30.0|||<|0.001|TWO_SIDED|95.0|18.1|41.5|||Miettinen and Nurminen method|||To compare the percentage of participants achieving SVR12 between the vaniprevir and control arms, 95% confidence intervals and corresponding p-values for the between-treatment difference (vaniprevir - control) were computed using Miettinen and Nurminen method stratified by IL28B and age utilizing Cochran-Mantel-Haenszel weights.||41.5|18.1|<0.001
72390542|NCT05673889|144288804|OTHER|Mixed Model|Ratio (%) of Adjusted Geometric Means|192.2|||||TWO_SIDED|90.0|166.56|221.79|||||The ratios (and 90% CIs) are expressed as percentages.|Dabigatran etexilate administered alone as Reference, ARV-471 coadministered with dabigatran etexilate as Test. Natural log transformed Cmax was analyzed using a mixed effect model with treatment as fixed effects and participant as a random effect. Estimates of the adjusted mean differences (Test-Reference) and corresponding 90% CIs were obtained from the model and were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||221.79|166.56|
72390543|NCT05673889|144288805|OTHER|Mixed Model|Ratio (%) of Adjusted Geometric Means|197.81|||||TWO_SIDED|90.0|177.32|220.66|||||The ratios (and 90% CIs) are expressed as percentages.|Dabigatran etexilate administered alone as Reference, ARV-471 coadministered with dabigatran etexilate as Test. Natural log transformed Cmax was analyzed using a mixed effect model with treatment as fixed effects and participant as a random effect. Estimates of the adjusted mean differences (Test-Reference) and corresponding 90% CIs were obtained from the model and were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||220.66|177.32|
72619402|NCT01370642|144769639|SUPERIORITY_OR_OTHER||Adjusted Difference in Percentages|29.6|||<|0.001|TWO_SIDED|95.0|18.3|41.0|||Miettinen and Nurminen method|||To compare the percentage of participants achieving SVR12 between the vaniprevir and control arms, 95% confidence intervals and corresponding p-values for the between-treatment difference (vaniprevir - control) were computed using Miettinen and Nurminen method stratified by IL28B and age utilizing Cochran-Mantel-Haenszel weights.||41.0|18.3|<0.001
72561443|NCT01525628|144653443|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 9 vs. Day 1 (%)|86.37|STANDARD_DEVIATION|18.1||0.1144|TWO_SIDED|90.0|77.62|96.11|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of tolbutamide at Day 9 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 9 vs. Day 1||96.11|77.62|0.1144
72561444|NCT01525628|144653443|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 17 vs. Day 1 (%)|64.66|STANDARD_DEVIATION|11.8||1|TWO_SIDED|90.0|60.42|69.2|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of tolbutamide at Day 17 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 17 vs. Day 1||69.20|60.42|1.0000
72561445|NCT01525628|144653443|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 66 vs. Day 1 (%)|63.75|STANDARD_DEVIATION|17.3||0.9988|TWO_SIDED|90.0|57.19|71.07|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of tolbutamide at Day 66 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 66 vs. Day 1||71.07|57.19|0.9988
72561446|NCT01525628|144653444|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 9 vs. Day 1 (%)|144.78|STANDARD_DEVIATION|19.0||0.9749|TWO_SIDED|90.0|128.3|163.36|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of Midazolam at Day 9 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 9 vs. Day 1||163.36|128.30|0.9749
72561447|NCT01525628|144653444|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 17 vs. Day 1 (%)|152.94|STANDARD_DEVIATION|26.8||0.9703|TWO_SIDED|90.0|128.6|181.89|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of Midazolam at Day 17 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 17 vs. Day 1||181.89|128.60|0.9703
72561448|NCT01525628|144653444|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 66 vs. Day 1 (%)|102.99|STANDARD_DEVIATION|29.3||0.05|TWO_SIDED|90.0|84.85|124.99|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of Midazolam at Day 66 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 66 vs. Day 1||124.99|84.85|0.0500
72561449|NCT01525628|144653444|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 9 vs. Day 1 (%)|124.22|STANDARD_DEVIATION|24.1||0.4697|TWO_SIDED|90.0|107.91|142.99|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of Midazolam at Day 9 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 9 vs. Day 1||142.99|107.91|0.4697
72498333|NCT03417440|144527033|SUPERIORITY||Mean Difference (Net)|0.0|STANDARD_DEVIATION|4.3||0.5|ONE_SIDED|90.0||1.1||a priori threshold for statistical significance=0.1 for 1-sided t-test; no adjustments for multiple comparisons made; if the outcome is not in the hypothesized direction, values that meet or exceed the 0.1 threshold will not be considered significant|t-test, 1 sided|||||1.1||0.50
72561450|NCT01525628|144653444|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 17 vs. Day 1 (%)|120.74|STANDARD_DEVIATION|19.2||0.2906|TWO_SIDED|90.0|108.47|134.38|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of Midazolam at Day 17 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 17 vs. Day 1||134.38|108.47|0.2906
72561451|NCT01525628|144653444|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 66 vs. Day 1 (%)|93.95|STANDARD_DEVIATION|25.2||0.046|TWO_SIDED|90.0|80.33|109.86|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of Midazolam at Day 66 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 66 vs. Day 1||109.86|80.33|0.0460
72498334|NCT03417440|144527033|SUPERIORITY||Mean Difference (Net)|1.2|STANDARD_DEVIATION|4.3||0.92|ONE_SIDED|90.0||2.3||a priori threshold for statistical significance=0.1 for 1-sided t-test; no adjustments for multiple comparisons made; if the outcome is not in the hypothesized direction, values that meet or exceed the 0.1 threshold will not be considered significant|t-test, 1 sided|||||2.3||0.92
72390544|NCT02228460|144288810|OTHER|||||||0.3173||||||Threshold for significance at 0.05 level.|McNemar Test|||A McNemar test was used to test the treatment effect based on paired pre-treatment and post-treatment (Week 26) frequencies of skin GL-3 score grouped into the categories (0 to \<2; 2 to 3).||||0.3173
72390545|NCT02228460|144288811|OTHER|||||||0.625||||||Threshold for significance at 0.05 level.|Wilcoxon signed rank test|||Wilcoxon signed rank test was used to assess the mean change from Baseline to Week 26 in skin GL-3 score.||||0.625
72390546|NCT00740831|144288833|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority analysis based on the use of one-sided confidence intervals, using 2.5% level of statistical significance.|Difference in proportions|1.2|||||ONE_SIDED|97.5|-9.3||||||Newcombe-Wilson method for CI. Percentage in A minus percentage in C needed to be greater than non-inferiority margin of -20%.|As comparison involved two doses of PGL4001 vs GnRH-agonist, Bonferroni correction used to adjust confidence intervals.|||-9.3|
72561452|NCT01525628|144653445|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 9 vs. Day 1 (%)|151.66|STANDARD_DEVIATION|18.5||0.9941|TWO_SIDED|90.0|134.79|170.64|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of Midazolam at Day 9 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 9 vs. Day 1||170.64|134.79|0.9941
72390547|NCT00740831|144288833|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority analysis based on the use of one-sided confidence intervals, using 2.5% level of statistical significance.|Difference in proportions|8.8|||||ONE_SIDED|97.5|0.4||||||Newcombe-Wilson method for CI. Percentage in B minus percentage in C needed to be greater than non-inferiority margin of -20%.|As comparison involved two doses of PGL4001 vs GnRH-agonist, Bonferroni correction used to adjust confidence intervals.|||0.4|
72390548|NCT00740831|144288834|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority|Mean Difference (Final Values)|0.089|||||TWO_SIDED|95.0|-0.003|0.181||No p-values generated|ANCOVA|Analysis of covariance after log transformation of the data|As comparison of 2 doses of PGL4001 vs GnRH-agonist, Bonneferroni correction used to adjust confidence intervals|||0.181|-0.003|
72390549|NCT00740831|144288834|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority|Mean Difference (Final Values)|0.049|||||TWO_SIDED|95.0|-0.043|0.14||No p-values generated|ANCOVA|Analysis of covariance after log transformation of the data|As comparison of 2 doses of PGL4001 vs GnRH-agonist, Bonneferroni correction used to adjust confidence intervals|||0.14|-0.043|
72390550|NCT00740831|144288835|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-28.3|||<|0.001|TWO_SIDED|95.0|-40.6|-14.6||Since comparisons of 2 doses of ulipristal acetate vs GnRH-agonist, Bonferroni correction was used, p values were doubled (p-value threshold was 0.05) and CI adjusted|Cochran-Mantel-Haenszel|Analysed via Cochran-Mantel-Haenszel test, controlling for strata||||-14.6|-40.6|<0.001
72390551|NCT00740831|144288835|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-29.9|||<|0.001|TWO_SIDED|95.0|-42.0|-16.6||Since comparisons of 2 doses of ulipristal acetate vs GnRH-agonist, Bonferroni correction was used, p values were doubled (p-value threshold was 0.05) and CI adjusted|Cochran-Mantel-Haenszel|Analysed via Cochran-Mantel-Haenszel test, controlling for strata||||-16.6|-42.0|<0.001
72390552|NCT00740831|144288836|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-28.3|||<|0.001|TWO_SIDED|95.0|-40.6|-14.6||Since planned analyses involved comparisons of 2 doses of PGL4001 vs GnRH-agonist, a Bonferroni correction was used and p values were doubled (p-value threshold was 0.05) and confidence intervals were similarly adjusted|Cochran-Mantel-Haenszel|Analysed via a Cochran-Mantel-Haenszel test, controlling for strata||||-14.6|-40.6|<0.001
72390553|NCT00740831|144288836|SUPERIORITY_OR_OTHER||Median Difference (Net)|-29.9|||<|0.001|TWO_SIDED|95.0|-42.0|-16.6||Since planned analyses involved comparisons of 2 doses of PGL4001 vs GnRH-agonist, a Bonferroni correction was used and p values were doubled (p-value threshold was 0.05) and confidence intervals were similarly adjusted|Cochran-Mantel-Haenszel|Analysed via a Cochran-Mantel-Haenszel test, controlling for strata||||-16.6|-42.0|<0.001
72390554|NCT03706079|144288837|SUPERIORITY||Rate Ratio|0.42|||||TWO_SIDED|95.0|0.35|0.51||||||||0.51|0.35|
72390555|NCT03706079|144288837|SUPERIORITY||Rate Ratio|0.61|||||TWO_SIDED|95.0|0.38|0.96||||||||0.96|0.38|
72447690|NCT03858634|144412942|SUPERIORITY||LS mean difference|2.4|STANDARD_ERROR_OF_MEAN|19.01||0.9019|TWO_SIDED|80.0|-22.91|27.67||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 12||27.67|-22.91|0.9019
72447691|NCT03858634|144412942|SUPERIORITY||LS mean difference|-149.2|STANDARD_ERROR_OF_MEAN|81.97||0.2103|TWO_SIDED|80.0|-303.77|5.35||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 12||5.35|-303.77|0.2103
72447692|NCT03858634|144412942|SUPERIORITY||LS mean difference|-22.1|STANDARD_ERROR_OF_MEAN|15.2||0.1634|TWO_SIDED|80.0|-42.4|-1.88||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 12||-1.88|-42.40|0.1634
72447693|NCT03858634|144412942|SUPERIORITY||LS mean difference|-48.6|STANDARD_ERROR_OF_MEAN|36.28||0.2727|TWO_SIDED|80.0|-108.04|10.8||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 14||10.80|-108.04|0.2727
72447694|NCT03858634|144412942|SUPERIORITY||LS mean difference|-9.6|STANDARD_ERROR_OF_MEAN|17.29||0.5839|TWO_SIDED|80.0|-32.65|13.36||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 14||13.36|-32.65|0.5839
72447695|NCT03858634|144412942|SUPERIORITY||LS mean difference|-167.8|STANDARD_ERROR_OF_MEAN|76.58||0.1597|TWO_SIDED|80.0|-312.25|-23.45||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 14||-23.45|-312.25|0.1597
72447696|NCT03858634|144412942|SUPERIORITY||LS mean difference|-27.1|STANDARD_ERROR_OF_MEAN|16.27||0.1138|TWO_SIDED|80.0|-48.81|-5.43||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 14||-5.43|-48.81|0.1138
72447697|NCT03858634|144412942|SUPERIORITY||LS mean difference|-62.0|STANDARD_ERROR_OF_MEAN|24.93||0.0888|TWO_SIDED|80.0|-102.78|-21.13||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 16||-21.13|-102.78|0.0888
72447698|NCT03858634|144412942|SUPERIORITY||LS mean difference|-0.6|STANDARD_ERROR_OF_MEAN|18.19||0.9741|TWO_SIDED|80.0|-24.79|23.6||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 16||23.60|-24.79|0.9741
72447699|NCT03858634|144412942|SUPERIORITY||LS mean difference|-159.2|STANDARD_ERROR_OF_MEAN|65.42||0.1354|TWO_SIDED|80.0|-282.59|-35.87||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 16||-35.87|-282.59|0.1354
72447700|NCT03858634|144412942|SUPERIORITY||LS mean difference|-26.5|STANDARD_ERROR_OF_MEAN|17.21||0.1425|TWO_SIDED|80.0|-49.41|-3.52||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 16||-3.52|-49.41|0.1425
72447701|NCT03858634|144412942|SUPERIORITY||LS mean difference|-54.6|STANDARD_ERROR_OF_MEAN|26.61||0.1326|TWO_SIDED|80.0|-98.18|-11.01||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 18||-11.01|-98.18|0.1326
72447702|NCT03858634|144412942|OTHER||LS mean difference|-4.2|STANDARD_ERROR_OF_MEAN|20.87||0.8433|TWO_SIDED|80.0|-31.95|23.58||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 18||23.58|-31.95|0.8433
72498335|NCT03417440|144527034|SUPERIORITY||Mean Difference (Net)|0.2|STANDARD_DEVIATION|4.2||0.42|ONE_SIDED|90.0|-0.9|||a priori threshold for statistical significance=0.1 for 1-sided t-test; no adjustments for multiple comparisons made; if the outcome is not in the hypothesized direction, values that meet or exceed the 0.1 threshold will not be considered significant|t-test, 1 sided||||||-0.9|0.42
72498336|NCT03417440|144527034|SUPERIORITY||Mean Difference (Net)|-0.8|STANDARD_DEVIATION|4.2||0.82|ONE_SIDED|90.0|-1.9|||a priori threshold for statistical significance=0.1 for 1-sided t-test; no adjustments for multiple comparisons made; if the outcome is not in the hypothesized direction, values that meet or exceed the 0.1 threshold will not be considered significant|t-test, 1 sided||||||-1.9|0.82
72498337|NCT03417440|144527034|SUPERIORITY||Mean Difference (Net)|-0.1|STANDARD_DEVIATION|4.2||0.58|ONE_SIDED|90.0|-1.2|||a priori threshold for statistical significance=0.1 for 1-sided t-test; no adjustments for multiple comparisons made; if the outcome is not in the hypothesized direction, values that meet or exceed the 0.1 threshold will not be considered significant|t-test, 1 sided||||||-1.2|0.58
72498338|NCT03417440|144527035|SUPERIORITY||Mean Difference (Net)|0.1|STANDARD_DEVIATION|4.0||0.45|ONE_SIDED|90.0|-0.9|||a priori threshold for statistical significance=0.1 for 1-sided t-test; no adjustments for multiple comparisons made; if the outcome is not in the hypothesized direction, values that meet or exceed the 0.1 threshold will not be considered significant|t-test, 1 sided||||||-0.9|0.45
72498339|NCT03417440|144527035|SUPERIORITY||Mean Difference (Net)|0.0|STANDARD_DEVIATION|3.9||0.49|ONE_SIDED|90.0|-1.0|||a priori threshold for statistical significance=0.1 for 1-sided t-test; no adjustments for multiple comparisons made; if the outcome is not in the hypothesized direction, values that meet or exceed the 0.1 threshold will not be considered significant|t-test, 1 sided||||||-1.0|0.49
72498340|NCT03417440|144527035|SUPERIORITY||Mean Difference (Net)|-0.2|STANDARD_DEVIATION|3.9||0.61|ONE_SIDED|90.0|-1.2|||a priori threshold for statistical significance=0.1 for 1-sided t-test; no adjustments for multiple comparisons made; if the outcome is not in the hypothesized direction, values that meet or exceed the 0.1 threshold will not be considered significant|t-test, 1 sided||||||-1.2|0.61
72498341|NCT03417440|144527036|SUPERIORITY|||||||0.84|||||||t-test, 2 sided|||||||.84
72447703|NCT03858634|144412942|SUPERIORITY||LS mean difference|-130.8|STANDARD_ERROR_OF_MEAN|38.5||0.0768|TWO_SIDED|80.0|-203.39|-58.19||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 18||-58.19|-203.39|0.0768
72498342|NCT03417440|144527036|SUPERIORITY|||||||0.96|||||||t-test, 2 sided|||||||.96
72498343|NCT03417440|144527036|SUPERIORITY|||||||0.41|||||||t-test, 2 sided|||||||.41
72498344|NCT03417440|144527037|SUPERIORITY|||||||0.13|||||||t-test, 2 sided|||||||.13
72561453|NCT01525628|144653445|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 17 vs. Day 1 (%)|163.42|STANDARD_DEVIATION|26.0||0.9926|TWO_SIDED|90.0|137.91|193.64|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of Midazolam at Day 17 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 17 vs. Day 1||193.64|137.91|0.9926
72447704|NCT03858634|144412942|SUPERIORITY||LS mean difference|-18.6|STANDARD_ERROR_OF_MEAN|18.69||0.3341|TWO_SIDED|80.0|-43.49|6.34||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 18||6.34|-43.49|0.3341
72447705|NCT03858634|144412944|SUPERIORITY||LS mean difference|-40.9|STANDARD_ERROR_OF_MEAN|40.82||0.4995|TWO_SIDED|80.0|-166.52|84.74||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 2||84.74|-166.52|0.4995
72447706|NCT03858634|144412944|SUPERIORITY||LS mean difference|-3.7|STANDARD_ERROR_OF_MEAN|9.59||0.7071|TWO_SIDED|80.0|-16.37|9.06||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 2||9.06|-16.37|0.7071
72498345|NCT03417440|144527037|SUPERIORITY|||||||0.2|||||||t-test, 2 sided|||||||0.20
72498346|NCT03417440|144527037|SUPERIORITY|||||||0.39|||||||t-test, 2 sided|||||||0.39
72498347|NCT03417440|144527038|OTHER||Spearman Correlation|-0.10435||||0.3116|TWO_SIDED||||||t distribution with n-2 degrees of freed|||Correlation between Self-efficacy for Physical Activity change and Daily Steps change across 4 months.||||0.3116
72498348|NCT03417440|144527038|OTHER||Spearman Correlation|0.17742||||0.0838|TWO_SIDED||||||t distribution with n-2 degrees of freed|||Correlation between Correlation between Self-regulation of Physical Activity change and Daily Steps change across 4 months.||||0.0838
72498349|NCT03417440|144527038|OTHER||Spearman Correlation|-0.09834||||0.351|TWO_SIDED||||||t distribution with n-2 degrees of freed|||Correlation between Family Social Support for Physical Activity change and Daily Steps change across 4 months.||||0.3510
72498350|NCT03417440|144527038|OTHER||Spearman Correlation|-0.04562||||0.6659|TWO_SIDED||||||t distribution with n-2 degrees of freed|||Correlation between Outcome Expectation for Physical Activity change and Daily Steps change across 4 months.||||0.6659
72498351|NCT03417440|144527038|OTHER||Spearman Correlation|-0.04831||||0.6402|TWO_SIDED||||||t distribution with n-2 degrees of freed|||Correlation between Aging Self-perceptions (Attitude Toward Own Aging) change and Daily Steps change across 4 months.||||0.6402
72498352|NCT03417440|144527038|OTHER||Spearman Correlation|0.13128||||0.2048|TWO_SIDED||||||t distribution with n-2 degrees of freed|||Correlation between Views of Aging--Psychosocial Loss change and Daily Steps change across 4 months.||||0.2048
72498353|NCT03417440|144527038|OTHER||Spearman Correlation|0.10022||||0.3445|TWO_SIDED||||||t distribution with n-2 degrees of freed|||Correlation between Views of Aging--Physical Change change and Daily Steps change across 4 months.||||0.3445
72498354|NCT03417440|144527038|OTHER||Spearman Correlation|-0.00866||||0.934|TWO_SIDED||||||t distribution with n-2 degrees of freed|||Correlation between Views of Aging--Psychological Growth change and Daily Steps change across 4 months.||||0.9340
72447707|NCT03858634|144412944|SUPERIORITY||LS mean difference|-52.5|STANDARD_ERROR_OF_MEAN|9.39||0.0305|TWO_SIDED|80.0|-70.18|-34.77||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 2||-34.77|-70.18|0.0305
72447708|NCT03858634|144412944|SUPERIORITY||LS mean difference|-6.6|STANDARD_ERROR_OF_MEAN|9.33||0.4884|TWO_SIDED|80.0|-19.01|5.81||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 2||5.81|-19.01|0.4884
72447709|NCT03858634|144412944|SUPERIORITY||LS mean difference|-45.3|STANDARD_ERROR_OF_MEAN|31.63||0.2885|TWO_SIDED|80.0|-104.93|14.35||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 4||14.35|-104.93|0.2885
72498355|NCT02706938|144527057|OTHER|One tail paired t test.|Mean Difference (Final Values)|1.3267|STANDARD_DEVIATION|2.1604||0.0002|TWO_SIDED|95.0|0.6263|2.027||A priori threshold for statistical significance was 0.05|t-test, 1 sided|||||2.0270|0.6263|0.0002
72498356|NCT02706938|144527057|OTHER|McNemar's chi squared statistic|Risk Difference (RD)|-0.359||||0.0082|TWO_SIDED|95.0|-0.6255|-0.0924||A priori threshold for statistical significance was 0.05|McNemar|||||-0.0924|-0.6255|0.0082
72498357|NCT02706938|144527058|OTHER|One tail paired t test.|Mean Difference (Final Values)|-6.9131|STANDARD_DEVIATION|32.5093||0.099|TWO_SIDED|95.0|-17.5987|3.7724||A priori threshold for statistical significance was 0.05|t-test, 1 sided|||||3.7724|-17.5987|0.099
72498358|NCT02706938|144527058|OTHER|McNemar's chi squared statistic|Risk Difference (RD)|-0.0263||||0.8084|TWO_SIDED|95.0|-0.2651|0.2125||A priori threshold for statistical significance was 0.05|McNemar|||||0.2125|-0.2651|0.8084
72498359|NCT01838044|144527060|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.287||0.6012|TWO_SIDED|95.0|-0.72|0.42|||Mixed Models Analysis|||Statistical analysis at Week 5 compared between two study arms.||0.42|-0.72|0.6012
72498360|NCT01838044|144527061|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.42|||<|0.0001|TWO_SIDED|95.0|1.02|1.83|||Mixed Models Analysis|||Statistical analysis of weekly mean pain NRS score in Arm B at Week 10.||1.83|1.02|<0.0001
72498361|NCT01838044|144527062|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.24|STANDARD_ERROR_OF_MEAN|0.361||0.5128|TWO_SIDED|95.0|-0.48|0.95|||Mixed Models Analysis|||Statistical analysis of weekly mean pain NRS score in Arm B compared between two study arms at Week 10.||0.95|-0.48|0.5128
72498362|NCT01838044|144527064|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.05|STANDARD_ERROR_OF_MEAN|0.14||0.7251|TWO_SIDED|95.0|-0.22|0.32|||Mixed Models Analysis|||Statistical analysis at Week 5 based on comparison between treatment groups.||0.32|-0.22|0.7251
72498363|NCT01838044|144527064|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|0.13||0.1255|TWO_SIDED|95.0|-0.06|0.46|||Mixed Models Analysis|||Statistical analysis at Week 10 based on comparison between treatment groups.||0.46|-0.06|0.1255
72498364|NCT01838044|144527066|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.34|STANDARD_ERROR_OF_MEAN|0.317||0.2856|TWO_SIDED|95.0|-0.97|0.29|||Mixed Models Analysis|||Statistical analysis at Week 5 compared between treatment groups.||0.29|-0.97|0.2856
72498365|NCT01838044|144527066|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.31|STANDARD_ERROR_OF_MEAN|0.363||0.3987|TWO_SIDED|95.0|-1.02|0.41|||Mixed Models Analysis|||Statistical analysis at Week 10 compared between treatment groups.||0.41|-1.02|0.3987
72498366|NCT00860470|144527083|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.95||||0.36|TWO_SIDED|95.0|0.86|1.06|||Regression, Logistic|Bonferroni-adjusted alpha=0.01 (for 5 comparisons)|GEE with log link function and exchangeable correlation was used to adjust confidence intervals for cluster randomised design; the iron-folic acid supplemented group was the referent.|||1.06|0.86|0.36
72561454|NCT01525628|144653445|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 66 vs. Day 1 (%)|98.14|STANDARD_DEVIATION|28.1||0.0392|TWO_SIDED|90.0|81.2|118.63|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of Midazolam at Day 66 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 66 vs. Day 1||118.63|81.20|0.0392
72447710|NCT03858634|144412944|SUPERIORITY||LS mean difference|5.2|STANDARD_ERROR_OF_MEAN|11.24||0.6505|TWO_SIDED|80.0|-9.73|20.06||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 4||20.06|-9.73|0.6505
72498367|NCT00860470|144527084|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.98||||0.78|TWO_SIDED|95.0|0.88|1.2|||Regression, Logistic||GEE with log link function and exchangeable correlation was used to adjust confidence intervals for cluster randomised design; the iron-folic acid supplemented group was the referent.|||1.20|0.88|0.78
72447711|NCT03858634|144412944|SUPERIORITY||LS mean difference|-72.1|STANDARD_ERROR_OF_MEAN|5.72||0.0062|TWO_SIDED|80.0|-82.91|-61.34||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 4||-61.34|-82.91|0.0062
72447712|NCT03858634|144412944|SUPERIORITY||LS mean difference|-19.6|STANDARD_ERROR_OF_MEAN|9.62||0.0571|TWO_SIDED|80.0|-32.34|-6.76||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 4||-6.76|-32.34|0.0571
72498368|NCT00860470|144527085|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.81||||0.11|TWO_SIDED|95.0|0.63|1.04|||Regression, Logistic||GEE with log link function and exchangeable correlation was used to adjust confidence intervals for cluster randomised design; the iron-folic acid supplemented group was the referent.|||1.04|0.63|0.11
72498369|NCT00860470|144527086|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.89||||0.02|TWO_SIDED|95.0|0.81|0.99|||Regression, Logistic|Bonferroni-adjusted alpha=0.01 (for 5 comparisons)|GEE with log link function and exchangeable correlation was used to adjust confidence intervals for cluster randomised design; the iron-folic acid supplemented group was the referent.|||0.99|0.81|0.02
72498370|NCT00860470|144527087|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.85|||<|0.001|TWO_SIDED|95.0|0.8|0.91|||Regression, Logistic|Bonferroni-adjusted alpha=0.01 (for 5 comparisons)|GEE with log link function and exchangeable correlation was used to adjust confidence intervals for cluster randomised design; the iron-folic acid supplemented group was the referent.|||0.91|0.80|<0.001
72447713|NCT03858634|144412944|SUPERIORITY||LS mean difference|-50.1|STANDARD_ERROR_OF_MEAN|0.0|||TWO_SIDED|||||||||Change at Week 6||||
72447714|NCT03858634|144412944|SUPERIORITY||LS mean difference|-4.3|STANDARD_ERROR_OF_MEAN|10.65||0.6927|TWO_SIDED|80.0|-18.38|9.84||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 6||9.84|-18.38|0.6927
72447715|NCT03858634|144412944|SUPERIORITY||LS mean difference|-65.6|STANDARD_ERROR_OF_MEAN|4.08||0.0038|TWO_SIDED|80.0|-73.33|-57.94||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 6||-57.94|-73.33|0.0038
72447716|NCT03858634|144412944|SUPERIORITY||LS mean difference|-17.4|STANDARD_ERROR_OF_MEAN|9.82||0.094|TWO_SIDED|80.0|-30.43|-4.3||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 6||-4.30|-30.43|0.0940
72447717|NCT03858634|144412944|SUPERIORITY||LS mean difference|-72.4|STANDARD_ERROR_OF_MEAN|19.73||0.1694|TWO_SIDED|80.0|-133.1|-11.65||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 8||-11.65|-133.10|0.1694
72447718|NCT03858634|144412944|SUPERIORITY||LS mean difference|2.8|STANDARD_ERROR_OF_MEAN|10.07||0.7811|TWO_SIDED|80.0|-10.5|16.18||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 8||16.18|-10.50|0.7811
72447719|NCT03858634|144412944|SUPERIORITY||LS mean difference|-68.2|STANDARD_ERROR_OF_MEAN|2.28||0.0011|TWO_SIDED|80.0|-72.51|-63.91||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 8||-63.91|-72.51|0.0011
72447720|NCT03858634|144412944|SUPERIORITY||LS mean difference|-23.4|STANDARD_ERROR_OF_MEAN|9.52||0.0245|TWO_SIDED|80.0|-36.02|-10.7||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 8||-10.70|-36.02|0.0245
72447721|NCT03858634|144412944|SUPERIORITY||LS mean difference|-61.8|STANDARD_ERROR_OF_MEAN|5.87||0.0603|TWO_SIDED|80.0|-79.88|-43.74||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 10||-43.74|-79.88|0.0603
72447722|NCT03858634|144412944|SUPERIORITY||LS mean difference|7.9|STANDARD_ERROR_OF_MEAN|9.89||0.4365|TWO_SIDED|80.0|-5.29|21.04||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 10||21.04|-5.29|0.4365
72447723|NCT03858634|144412944|SUPERIORITY||LS mean difference|-68.7|STANDARD_ERROR_OF_MEAN|10.3||0.0218|TWO_SIDED|80.0|-88.11|-49.26||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 10||-49.26|-88.11|0.0218
72447724|NCT03858634|144412944|SUPERIORITY||LS mean difference|-19.5|STANDARD_ERROR_OF_MEAN|12.07||0.1238|TWO_SIDED|80.0|-35.65|-3.45||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 10||-3.45|-35.65|0.1238
72447725|NCT03858634|144412944|SUPERIORITY||LS mean difference|-54.8|STANDARD_ERROR_OF_MEAN|23.38||0.1437|TWO_SIDED|80.0|-98.88|-10.72||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 12||-10.72|-98.88|0.1437
72447726|NCT03858634|144412944|SUPERIORITY||LS mean difference|0.9|STANDARD_ERROR_OF_MEAN|10.14||0.9279|TWO_SIDED|80.0|-12.56|14.43||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 12||14.43|-12.56|0.9279
72447727|NCT03858634|144412944|SUPERIORITY||LS mean difference|-59.5|STANDARD_ERROR_OF_MEAN|9.67||0.0254|TWO_SIDED|80.0|-77.69|-41.24||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 12||-41.24|-77.69|0.0254
72447728|NCT03858634|144412944|SUPERIORITY||LS mean difference|-18.8|STANDARD_ERROR_OF_MEAN|10.8||0.0994|TWO_SIDED|80.0|-33.23|-4.43||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 12||-4.43|-33.23|0.0994
72447729|NCT03858634|144412944|SUPERIORITY||LS mean difference|-45.7|STANDARD_ERROR_OF_MEAN|39.36||0.3656|TWO_SIDED|80.0|-119.9|28.54||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 14||28.54|-119.90|0.3656
72447730|NCT03858634|144412944|SUPERIORITY||LS mean difference|-2.9|STANDARD_ERROR_OF_MEAN|8.92||0.7465|TWO_SIDED|80.0|-14.79|8.94||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 14||8.94|-14.79|0.7465
72447731|NCT03858634|144412944|SUPERIORITY||LS mean difference|-82.3|STANDARD_ERROR_OF_MEAN|10.3||0.0153|TWO_SIDED|80.0|-101.75|-62.9||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 14||-62.90|-101.75|0.0153
72447732|NCT03858634|144412944|SUPERIORITY||LS mean difference|-16.6|STANDARD_ERROR_OF_MEAN|12.97||0.2184|TWO_SIDED|80.0|-33.88|0.72||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 14||0.72|-33.88|0.2184
72447733|NCT03858634|144412944|SUPERIORITY||LS mean difference|-8.1|STANDARD_ERROR_OF_MEAN|25.78||0.7726|TWO_SIDED|80.0|-50.37|34.07||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 16||34.07|-50.37|0.7726
72447734|NCT03858634|144412944|SUPERIORITY||LS mean difference|-9.2|STANDARD_ERROR_OF_MEAN|12.66||0.476|TWO_SIDED|80.0|-26.07|7.63||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 16||7.63|-26.07|0.4760
72498371|NCT00860470|144527088|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.75||||0.03|TWO_SIDED|95.0|0.57|0.97|||Regression, Logistic||GEE with log link function and exchangeable correlation was used to adjust confidence intervals for cluster randomised design; the iron-folic acid supplemented group was the referent.|||0.97|0.57|0.03
72561455|NCT01525628|144653445|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 9 vs. Day 1 (%)|122.58|STANDARD_DEVIATION|37.2||0.4374|TWO_SIDED|90.0|99.15|151.55|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of Midazolam at Day 9 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 9 vs. Day 1||151.55|99.15|0.4374
72561456|NCT01525628|144653445|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 17 vs. Day 1 (%)|130.44|STANDARD_DEVIATION|35.3||0.647|TWO_SIDED|90.0|107.57|158.18|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of Midazolam at Day 17 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 17 vs. Day 1||158.18|107.57|0.6470
72561457|NCT01525628|144653445|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 66 vs. Day 1 (%)|87.77|STANDARD_DEVIATION|36.9||0.2372|TWO_SIDED|90.0|70.32|109.54|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of Midazolam at Day 66 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 66 vs. Day 1||109.54|70.32|0.2372
72561458|NCT01525628|144653446|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 9 vs. Day 1 (%)|117.67|STANDARD_DEVIATION|15.6||0.1519|TWO_SIDED|90.0|106.49|130.0|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of 1-OH-Midazolam at Day 9 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 9 vs. Day 1||130.00|106.49|0.1519
72561459|NCT01525628|144653446|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 17 vs. Day 1 (%)|117.01|STANDARD_DEVIATION|30.9||0.2827|TWO_SIDED|90.0|96.06|142.52|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of 1-OH-Midazolam at Day 17 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day17 vs. Day 1||142.52|96.06|0.2827
72619403|NCT01370642|144769640|SUPERIORITY_OR_OTHER||Adjusted Difference in Percentages|78.1|||<|0.001|TWO_SIDED|95.0|68.2|85.3|||Miettinen and Nurminen method|||To compare the percentage of participants achieving RVR between the vaniprevir and control arms, 95% confidence intervals and corresponding p-values for the between-treatment difference (vaniprevir - control) were computed using Miettinen and Nurminen method stratified by IL28B and age utilizing Cochran-Mantel-Haenszel weights.||85.3|68.2|<0.001
72619404|NCT01370642|144769640|SUPERIORITY_OR_OTHER||Adjusted Difference in Percentages|76.7|||<|0.001|TWO_SIDED|95.0|66.7|84.1|||Miettinen and Nurminen method|||To compare the percentage of participants achieving RVR between the vaniprevir and control arms, 95% confidence intervals and corresponding p-values for the between-treatment difference (vaniprevir - control) were computed using Miettinen and Nurminen method stratified by IL28B and age utilizing Cochran-Mantel-Haenszel weights.||84.1|66.7|<0.001
72619405|NCT01370642|144769641|SUPERIORITY_OR_OTHER||Adjusted Difference in Percentages|48.4|||<|0.001|TWO_SIDED|95.0|37.2|58.9|||Miettinen and Nurminen method|||To compare the percentage of participants achieving cEVR between the vaniprevir and control arms, 95% confidence intervals and corresponding p-values for the between-treatment difference (vaniprevir - control) were computed using Miettinen and Nurminen method stratified by IL28B and age utilizing Cochran-Mantel-Haenszel weights.||58.9|37.2|<0.001
72447735|NCT03858634|144412944|SUPERIORITY||LS mean difference|-82.1|STANDARD_ERROR_OF_MEAN|9.12||0.0121|TWO_SIDED|80.0|-99.26|-64.87||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 16||-64.87|-99.26|0.0121
72447736|NCT03858634|144412944|SUPERIORITY||LS mean difference|-13.0|STANDARD_ERROR_OF_MEAN|13.06||0.3329|TWO_SIDED|80.0|-30.43|4.4||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 16||4.40|-30.43|0.3329
72447737|NCT03858634|144412944|SUPERIORITY||LS mean difference|-1.7|STANDARD_ERROR_OF_MEAN|28.46||0.9564|TWO_SIDED|80.0|-48.31|44.92||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 18||44.92|-48.31|0.9564
72447738|NCT03858634|144412944|SUPERIORITY||LS mean difference|-7.9|STANDARD_ERROR_OF_MEAN|13.49||0.5661|TWO_SIDED|80.0|-25.84|10.06||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 18||10.06|-25.84|0.5661
72447739|NCT03858634|144412944|SUPERIORITY||LS mean difference|-82.1|STANDARD_ERROR_OF_MEAN|9.12||0.0121|TWO_SIDED|80.0|-99.26|-64.87||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 18||-64.87|-99.26|0.0121
72447740|NCT03858634|144412944|SUPERIORITY||LS mean difference|-11.1|STANDARD_ERROR_OF_MEAN|13.7||0.4275|TWO_SIDED|80.0|-29.4|7.13||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 18||7.13|-29.40|0.4275
72447741|NCT03858634|144412949|SUPERIORITY||LS mean difference|-27.9|STANDARD_ERROR_OF_MEAN|40.54||0.5403|TWO_SIDED|80.0|-94.32|38.46||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 1||38.46|-94.32|0.5403
72447742|NCT03858634|144412949|SUPERIORITY||LS mean difference|376.1|STANDARD_ERROR_OF_MEAN|631.83||0.5587|TWO_SIDED|80.0|-462.83|1214.97||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 1||1214.97|-462.83|0.5587
72447743|NCT03858634|144412949|SUPERIORITY||LS mean difference|-67.7|STANDARD_ERROR_OF_MEAN|72.99||0.4516|TWO_SIDED|80.0|-205.33|69.93||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 1||69.93|-205.33|0.4516
72447744|NCT03858634|144412949|SUPERIORITY||LS mean difference|-12.5|STANDARD_ERROR_OF_MEAN|9.5||0.2052|TWO_SIDED|80.0|-25.13|0.15||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 1||0.15|-25.13|0.2052
72447745|NCT03858634|144412949|SUPERIORITY||LS mean difference|-59.4|STANDARD_ERROR_OF_MEAN|38.89||0.224|TWO_SIDED|80.0|-123.09|4.28||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 2||4.28|-123.09|0.2240
72447746|NCT03858634|144412949|SUPERIORITY||LS mean difference|39.5|STANDARD_ERROR_OF_MEAN|48.33||0.4242|TWO_SIDED|80.0|-24.7|103.65||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 2||103.65|-24.70|0.4242
72447747|NCT03858634|144412949|SUPERIORITY||LS mean difference|-77.2|STANDARD_ERROR_OF_MEAN|78.61||0.4295|TWO_SIDED|80.0|-225.44|71.01||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 2||71.01|-225.44|0.4295
72447748|NCT03858634|144412949|SUPERIORITY||LS mean difference|-18.7|STANDARD_ERROR_OF_MEAN|14.97||0.2272|TWO_SIDED|80.0|-38.64|1.2||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 2||1.20|-38.64|0.2272
72447749|NCT03858634|144412949|SUPERIORITY||LS mean difference|-55.1|STANDARD_ERROR_OF_MEAN|48.9||0.3416|TWO_SIDED|80.0|-135.23|24.95||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 3||24.95|-135.23|0.3416
72447750|NCT03858634|144412949|SUPERIORITY||LS mean difference|57.6|STANDARD_ERROR_OF_MEAN|69.75||0.4192|TWO_SIDED|80.0|-35.02|150.19||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 3||150.19|-35.02|0.4192
72447751|NCT03858634|144412949|SUPERIORITY||LS mean difference|-66.8|STANDARD_ERROR_OF_MEAN|87.42||0.5245|TWO_SIDED|80.0|-231.66|98.02||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 3||98.02|-231.66|0.5245
72447752|NCT03858634|144412949|SUPERIORITY||LS mean difference|-17.8|STANDARD_ERROR_OF_MEAN|13.31||0.1988|TWO_SIDED|80.0|-35.47|-0.05||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 3||-0.05|-35.47|0.1988
72498372|NCT00860470|144527089|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.73|||<|0.001|TWO_SIDED|95.0|0.62|0.86|||Regression, Logistic||GEE with log link function and exchangeable correlation was used to adjust confidence intervals for cluster randomised design; the iron-folic acid supplemented group was the referent.|||0.86|0.62|<0.001
72498373|NCT00860470|144527090|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.87||||0.87|TWO_SIDED|95.0|0.81|0.93|||Regression, Logistic||GEE with log link function and exchangeable correlation was used to adjust confidence intervals for cluster randomised design; the iron-folic acid supplemented group was the referent.|||0.93|0.81|0.87
72498374|NCT00860470|144527091|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.88|||<|0.001|TWO_SIDED|95.0|0.85|0.91|||Regression, Logistic|Bonferroni-adjusted alpha=0.01 (for 5 comparisons)|GEE with log link function and exchangeable correlation was used to adjust confidence intervals for cluster randomised design; the iron-folic acid supplemented group was the referent.|||0.91|0.85|<0.001
72561460|NCT01525628|144653446|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 66 vs. Day 1 (%)|92.11|STANDARD_DEVIATION|32.6||0.1326|TWO_SIDED|90.0|74.38|114.07|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of 1-OH-Midazolam at Day 66 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 66 vs. Day 1||114.07|74.38|0.1326
72561461|NCT01525628|144653446|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 9 vs. Day 1 (%)|95.55|STANDARD_DEVIATION|29.2||0.0432|TWO_SIDED|90.0|80.63|113.24|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of 1-OH-Midazolam at Day 9 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 9 vs. Day 1||113.24|80.63|0.0432
72561462|NCT01525628|144653446|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 17 vs. Day 1 (%)|75.19|STANDARD_DEVIATION|30.3||0.7367|TWO_SIDED|90.0|63.64|88.82|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of 1-OH-Midazolam at Day 17 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 17 vs. Day 1||88.82|63.64|0.7367
72561463|NCT01525628|144653446|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 66 vs. Day 1 (%)|70.14|STANDARD_DEVIATION|34.3||0.8547|TWO_SIDED|90.0|56.84|86.56|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of 1-OH-Midazolam at Day 66 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 66 vs. Day 1||86.56|56.84|0.8547
72561464|NCT01525628|144653447|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 9 vs. Day 1 (%)|102.7|STANDARD_DEVIATION|45.9||0.1159|TWO_SIDED|90.0|77.89|135.39|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of 1-OH-Midazolam at Day 9 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 9 vs. Day 1||135.39|77.89|0.1159
72447753|NCT03858634|144412949|SUPERIORITY||LS mean difference|-69.2|STANDARD_ERROR_OF_MEAN|56.11||0.3054|TWO_SIDED|80.0|-161.08|22.72||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 4||22.72|-161.08|0.3054
72447754|NCT03858634|144412949|SUPERIORITY||LS mean difference|229.4|STANDARD_ERROR_OF_MEAN|377.23||0.5504|TWO_SIDED|80.0|-271.51|730.22||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 4||730.22|-271.51|0.5504
72447755|NCT03858634|144412949|SUPERIORITY||LS mean difference|-71.2|STANDARD_ERROR_OF_MEAN|76.27||0.4493|TWO_SIDED|80.0|-214.96|72.65||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 4||72.65|-214.96|0.4493
72447756|NCT03858634|144412949|SUPERIORITY||LS mean difference|-40.3|STANDARD_ERROR_OF_MEAN|20.63||0.0665|TWO_SIDED|80.0|-67.74|-12.85||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 4||-12.85|-67.74|0.0665
72447757|NCT03858634|144412949|SUPERIORITY||LS mean difference|-78.7|STANDARD_ERROR_OF_MEAN|54.04||0.2411|TWO_SIDED|80.0|-167.25|9.75||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 5||9.75|-167.25|0.2411
72447758|NCT03858634|144412949|SUPERIORITY||LS mean difference|60.8|STANDARD_ERROR_OF_MEAN|79.3||0.4528|TWO_SIDED|80.0|-44.51|166.08||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 5||166.08|-44.51|0.4528
72447759|NCT03858634|144412949|SUPERIORITY||LS mean difference|-41.4|STANDARD_ERROR_OF_MEAN|75.46||0.6381|TWO_SIDED|80.0|-183.72|100.85||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 5||100.85|-183.72|0.6381
72447760|NCT03858634|144412949|SUPERIORITY||LS mean difference|-31.5|STANDARD_ERROR_OF_MEAN|17.22||0.0837|TWO_SIDED|80.0|-54.44|-8.62||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 5||-8.62|-54.44|0.0837
72447761|NCT03858634|144412949|SUPERIORITY||LS mean difference|-74.7|STANDARD_ERROR_OF_MEAN|66.45||0.3428|TWO_SIDED|80.0|-183.53|34.13||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 6||34.13|-183.53|0.3428
72447762|NCT03858634|144412949|SUPERIORITY||LS Mean Difference|21.8|STANDARD_ERROR_OF_MEAN|22.93||0.3533|TWO_SIDED|80.0|-8.63|52.27||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 6||52.27|-8.63|0.3533
72447763|NCT03858634|144412949|SUPERIORITY||LS Mean Difference|-63.9|STANDARD_ERROR_OF_MEAN|56.53||0.3755|TWO_SIDED|80.0|-170.51|42.66||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 6||42.66|-170.51|0.3755
72498375|NCT00860470|144527092|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.98||||0.13|TWO_SIDED|95.0|0.96|1.01|||Regression, Logistic|Bonferroni-adjusted alpha=0.01 (for 5 comparisons)|GEE with log link function and exchangeable correlation was used to adjust confidence intervals for cluster randomised design; the iron-folic acid supplemented group was the referent.|||1.01|0.96|0.13
72498376|NCT00723957|144527097|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.04|||||ONE_SIDED|90.0||1.41|||Regression, Cox|||||1.41||
72619406|NCT01370642|144769641|SUPERIORITY_OR_OTHER||Adjusted Difference in Percentages|49.6|||<|0.001|TWO_SIDED|95.0|38.5|60.0|||Miettinen and Nurminen method|||To compare the percentage of participants achieving cEVR between the vaniprevir and control arms, 95% confidence intervals and corresponding p-values for the between-treatment difference (vaniprevir - control) were computed using Miettinen and Nurminen method stratified by IL28B and age utilizing Cochran-Mantel-Haenszel weights.||60.0|38.5|<0.001
72447764|NCT03858634|144412949|SUPERIORITY||LS Mean Difference|-37.6|STANDARD_ERROR_OF_MEAN|15.6||0.0268|TWO_SIDED|80.0|-58.39|-16.87||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 6||-16.87|-58.39|0.0268
72447765|NCT03858634|144412949|SUPERIORITY||LS Mean Difference|-79.5|STANDARD_ERROR_OF_MEAN|43.79||0.1672|TWO_SIDED|80.0|-151.2|-7.75||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 7||-7.75|-151.20|0.1672
72447766|NCT03858634|144412949|SUPERIORITY||LS Mean Difference|43.7|STANDARD_ERROR_OF_MEAN|45.81||0.3518|TWO_SIDED|80.0|-17.09|104.55||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 7||104.55|-17.09|0.3518
72447767|NCT03858634|144412949|SUPERIORITY||LS Mean Difference|-68.7|STANDARD_ERROR_OF_MEAN|49.22||0.2974|TWO_SIDED|80.0|-161.52|24.09||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 7||24.09|-161.52|0.2974
72447768|NCT03858634|144412949|SUPERIORITY||LS Mean Difference|-38.1|STANDARD_ERROR_OF_MEAN|18.6||0.0555|TWO_SIDED|80.0|-62.83|-13.33||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 7||-13.33|-62.83|0.0555
72447769|NCT03858634|144412949|SUPERIORITY||LS Mean Difference|-78.3|STANDARD_ERROR_OF_MEAN|56.72||0.2614|TWO_SIDED|80.0|-171.17|14.62||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 8||14.62|-171.17|0.2614
72447770|NCT03858634|144412949|SUPERIORITY||LS Mean Difference|31.7|STANDARD_ERROR_OF_MEAN|37.89||0.4134|TWO_SIDED|80.0|-18.62|81.98||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 8||81.98|-18.62|0.4134
72498377|NCT00723957|144527097|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5735|||||||Log Rank|||P-value is 1-sided||||0.5735
72498378|NCT00723957|144527098|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.78|||||ONE_SIDED|90.0||1.1|||Regression, Cox|||||1.10||
72498379|NCT00723957|144527098|SUPERIORITY_OR_OTHER_LEGACY|||||||0.175|||||||Log Rank|||P-value is 1-sided||||0.1750
72447771|NCT03858634|144412949|SUPERIORITY||LS Mean Difference|-69.6|STANDARD_ERROR_OF_MEAN|44.99||0.262|TWO_SIDED|80.0|-154.44|15.24||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 8||15.24|-154.44|0.2620
72447772|NCT03858634|144412949|SUPERIORITY||LS Mean Difference|-40.2|STANDARD_ERROR_OF_MEAN|16.7||0.0269|TWO_SIDED|80.0|-62.46|-18.02||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 8||-18.02|-62.46|0.0269
72447773|NCT03858634|144412949|SUPERIORITY||LS Mean Difference|-81.2|STANDARD_ERROR_OF_MEAN|45.32||0.1709|TWO_SIDED|80.0|-155.46|-7.02||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 10||-7.02|-155.46|0.1709
72498380|NCT00723957|144527099|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.92|||||ONE_SIDED|90.0||1.15|||Regression, Cox|||||1.15||
72498381|NCT00723957|144527099|SUPERIORITY_OR_OTHER_LEGACY|||||||0.316|ONE_SIDED||||||Log Rank|||P-value is 1-sided||||0.316
72498382|NCT00723957|144527105|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.6|||||ONE_SIDED|90.0||2.1|||Regression, Cox||β3T+ subgroup|||2.10||
72498383|NCT00723957|144527105|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.7|||||ONE_SIDED|90.0||0.9|||Regression, Cox||β3T- subgroup|||0.90||
72498384|NCT00723957|144527105|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.1|||||ONE_SIDED|90.0||1.4|||Regression, Cox||Overall population|||1.40||
72498385|NCT00706628|144527108|SUPERIORITY_OR_OTHER|||||||0.0577|||||||Fisher Exact|||||||0.0577
72498386|NCT00706628|144527108|SUPERIORITY_OR_OTHER|||||||0.0863|||||||Fisher Exact|||||||0.0863
72498387|NCT00706628|144527110|SUPERIORITY_OR_OTHER||Slope|1.4823|STANDARD_ERROR_OF_MEAN|0.149|||TWO_SIDED|95.0|1.1754|1.7892||||||||1.7892|1.1754|
72447774|NCT03858634|144412949|SUPERIORITY||LS Mean Difference|42.9|STANDARD_ERROR_OF_MEAN|12.98||0.0042|TWO_SIDED|80.0|25.61|60.22||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 10||60.22|25.61|0.0042
72447775|NCT03858634|144412949|SUPERIORITY||LS Mean Difference|-53.2|STANDARD_ERROR_OF_MEAN|47.22||0.3772|TWO_SIDED|80.0|-142.19|35.88||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 10||35.88|-142.19|0.3772
72447776|NCT03858634|144412949|SUPERIORITY||LS Mean Difference|-28.3|STANDARD_ERROR_OF_MEAN|15.54||0.0857|TWO_SIDED|80.0|-49.06|-7.63||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 10||-7.63|-49.06|0.0857
72447777|NCT03858634|144412949|SUPERIORITY||LS Mean Difference|-77.3|STANDARD_ERROR_OF_MEAN|26.34||0.0607|TWO_SIDED|80.0|-120.48|-34.2||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 12||-34.20|-120.48|0.0607
72447778|NCT03858634|144412949|SUPERIORITY||LS Mean Difference|88.8|STANDARD_ERROR_OF_MEAN|124.79||0.4862|TWO_SIDED|80.0|-77.57|255.22||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 12||255.22|-77.57|0.4862
72561465|NCT01525628|144653447|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 17 vs. Day 1 (%)|99.99|STANDARD_DEVIATION|38.7||0.0651|TWO_SIDED|90.0|78.33|127.64|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of 1-OH-Midazolam at Day 17 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 17 vs. Day 1||127.64|78.33|0.0651
72561466|NCT01525628|144653447|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 66 vs. Day 1 (%)|78.29|STANDARD_DEVIATION|34.3||0.5658|TWO_SIDED|90.0|62.5|98.07|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of 1-OH-Midazolam at Day 66 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 66 vs. Day 1||98.07|62.50|0.5658
72561467|NCT01525628|144653447|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 9 vs. Day 1 (%)|108.25|STANDARD_DEVIATION|37.2||0.1286|TWO_SIDED|90.0|87.46|133.99|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of 1-OH-Midazolam at Day 9 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 9 vs. Day 1||133.99|87.46|0.1286
72561468|NCT01525628|144653447|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 17 vs. Day 1 (%)|87.59|STANDARD_DEVIATION|31.8||0.1898|TWO_SIDED|90.0|73.56|104.3|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of 1-OH-Midazolam at Day 17 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 17 vs. Day 1||104.30|73.56|0.1898
72561469|NCT01525628|144653447|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 66 vs. Day 1 (%)|78.42|STANDARD_DEVIATION|36.3||0.5575|TWO_SIDED|90.0|61.81|99.51|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of 1-OH-Midazolam at Day 66 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 66 vs. Day 1||99.51|61.81|0.5575
72561470|NCT01705717|144653519|SUPERIORITY_OR_OTHER|||||||0.034|TWO_SIDED||||||Chi-squared|||||||0.034
72561471|NCT01705717|144653520|SUPERIORITY_OR_OTHER|||||||0.007|TWO_SIDED||||||Chi-squared|||||||0.007
72561472|NCT02754492|144653544|OTHER|A procedure is a success if the subject's platelet product has a residual WBC count of \< 5.0 × 10\^6 for the single platelet product group. The FDA requirements are met if the lower one-sided 95% confidence interval for the procedure success rate is at least 95%.|Simple Sample Proportion|0.989|STANDARD_ERROR_OF_MEAN|0.0107|||ONE_SIDED|95.0|0.95|||||||Up to 350 healthy adult subjects will be enrolled in this study to ensure 93 evaluable single platelet product collections, 93 evaluable double platelet product collections, and 93 evaluable triple platelet product collections. This number was chosen to meet the FDA requirements of at least 95% of platelet units with an acceptable residual WBC level with 95% confidence. With 93 platelet products, this allowed for at most 1 failure.|||0.950|
72561473|NCT02754492|144653544|OTHER|A procedure is a success if the subject's platelet product has a residual WBC count of \< 8.0 × 10\^6 for the double platelet product group, or \< 5.0 × 10\^6 for each transfusable unit . The FDA requirements are met if the lower one-sided 95% confidence interval for the procedure success rate is at least 95%.|Simple Sample Proportion|1.0|STANDARD_ERROR_OF_MEAN|0.0|||ONE_SIDED|95.0|0.968||||||When estimated proportion is 100%, standard error of the mean is estimated as 0.|Up to 350 healthy adult subjects will be enrolled in this study to ensure 93 evaluable single platelet product collections, 93 evaluable double platelet product collections, and 93 evaluable triple platelet product collections. This number was chosen to meet the FDA requirements of at least 95% of platelet units with an acceptable residual WBC level with 95% confidence. With 93 platelet products, this allowed for at most 1 failure.|||0.968|
72447779|NCT03858634|144412949|SUPERIORITY||LS Mean Difference|-53.2|STANDARD_ERROR_OF_MEAN|49.73||0.3968|TWO_SIDED|80.0|-146.96|40.58||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 12||40.58|-146.96|0.3968
72447780|NCT03858634|144412949|SUPERIORITY||LS Mean Difference|-24.2|STANDARD_ERROR_OF_MEAN|16.57||0.1624|TWO_SIDED|80.0|-46.31|-2.11||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 12||-2.11|-46.31|0.1624
72447781|NCT03858634|144412949|SUPERIORITY||LS Mean Difference|-76.8|STANDARD_ERROR_OF_MEAN|37.75||0.1349|TWO_SIDED|80.0|-138.58|-14.93||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 14||-14.93|-138.58|0.1349
72447782|NCT03858634|144412949|SUPERIORITY||LS Mean Difference|45.5|STANDARD_ERROR_OF_MEAN|21.81||0.0525|TWO_SIDED|80.0|16.38|74.56||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 14||74.56|16.38|0.0525
72447783|NCT03858634|144412949|SUPERIORITY||LS Mean Difference|-76.6|STANDARD_ERROR_OF_MEAN|50.98||0.2719|TWO_SIDED|80.0|-172.71|19.55||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 14||19.55|-172.71|0.2719
72447784|NCT03858634|144412949|SUPERIORITY||LS Mean Difference|-30.7|STANDARD_ERROR_OF_MEAN|17.39||0.0957|TWO_SIDED|80.0|-53.86|-7.49||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 14||-7.49|-53.86|0.0957
72447785|NCT03858634|144412949|SUPERIORITY||LS Mean Difference|-79.8|STANDARD_ERROR_OF_MEAN|32.98||0.0942|TWO_SIDED|80.0|-133.83|-25.78||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 16||-25.78|-133.83|0.0942
72498388|NCT01264939|144527122|SUPERIORITY_OR_OTHER||Least squares mean difference|-4.52|||<|0.0001|TWO_SIDED|95.0|-5.97|-3.08||Multiplicity plan applied to the efficacy endpoints provided strong control of the type I error rate at 0.05 level by pre-specifying the hierarchical order of the efficacy endpoint tests.|ANCOVA|Covariates included in the analysis were baseline weekly itch severity score (\< 13 vs ≥ 13) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis was that there was no difference between the placebo and the omalizumab 300 mg groups.||-3.08|-5.97|<0.0001
72619407|NCT01370642|144769642|SUPERIORITY_OR_OTHER||Adjusted Difference in Percentages|17.0|||<|0.001|TWO_SIDED|95.0|8.1|27.3|||Miettinen and Nurminen method|||To compare the percentage of participants achieving undetectable HCV RNA at EOT between the vaniprevir and control arms, 95% confidence intervals and corresponding p-values for the between-treatment difference (vaniprevir - control) were computed using Miettinen and Nurminen method stratified by IL28B and age utilizing Cochran-Mantel-Haenszel weights.||27.3|8.1|<0.001
72447786|NCT03858634|144412949|SUPERIORITY||LS Mean Difference|34.6|STANDARD_ERROR_OF_MEAN|23.6||0.1606|TWO_SIDED|80.0|3.16|66.09||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 16||66.09|3.16|0.1606
72447787|NCT03858634|144412949|SUPERIORITY||LS Mean Difference|-77.0|STANDARD_ERROR_OF_MEAN|42.2||0.2096|TWO_SIDED|80.0|-156.58|2.58||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 16||2.58|-156.58|0.2096
72447788|NCT03858634|144412949|SUPERIORITY||LS Mean Difference|-29.3|STANDARD_ERROR_OF_MEAN|18.32||0.1279|TWO_SIDED|80.0|-53.74|-4.89||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 16||-4.89|-53.74|0.1279
72447789|NCT03858634|144412949|SUPERIORITY||LS Mean Difference|-75.0|STANDARD_ERROR_OF_MEAN|23.17||0.0479|TWO_SIDED|80.0|-112.96|-37.08||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 18||-37.08|-112.96|0.0479
72447790|NCT03858634|144412949|SUPERIORITY||LS Mean Difference|32.8|STANDARD_ERROR_OF_MEAN|22.91||0.17|TWO_SIDED|80.0|2.28|63.37||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 18||63.37|2.28|0.1700
72447791|NCT03858634|144412949|SUPERIORITY||LS Mean Difference|-80.1|STANDARD_ERROR_OF_MEAN|29.67||0.1142|TWO_SIDED|80.0|-136.03|-24.15||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 18||-24.15|-136.03|0.1142
72447792|NCT03858634|144412949|SUPERIORITY||LS Mean Difference|-18.0|STANDARD_ERROR_OF_MEAN|20.82||0.398|TWO_SIDED|80.0|-45.8|9.71||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 18||9.71|-45.80|0.3980
72498389|NCT01264939|144527123|SUPERIORITY_OR_OTHER||Least squares mean difference|-10.02|||<|0.0001|TWO_SIDED|95.0|-13.17|-6.86||Multiplicity plan applied to the efficacy endpoints provided strong control of the type I error rate at 0.05 level by pre-specifying the hierarchical order of the efficacy endpoint tests.|ANCOVA|Covariates included in the analysis were baseline UAS7 (\< median vs ≥ median) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis was that there was no difference between the placebo and the omalizumab 300 mg groups.||-6.86|-13.17|<0.0001
72447793|NCT03858634|144412951|SUPERIORITY||LS mean difference|-13.2|STANDARD_ERROR_OF_MEAN|17.11||0.4979|TWO_SIDED|80.0|-41.17|14.86||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 1||14.86|-41.17|0.4979
72447794|NCT03858634|144412951|SUPERIORITY||LS mean difference|21.7|STANDARD_ERROR_OF_MEAN|12.88||0.1079|TWO_SIDED|80.0|4.63|38.83||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 1||38.83|4.63|0.1079
72447795|NCT03858634|144412951|SUPERIORITY||LS mean difference|-35.6|STANDARD_ERROR_OF_MEAN|41.7||0.4837|TWO_SIDED|80.0|-114.19|43.07||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 1||43.07|-114.19|0.4837
72447796|NCT03858634|144412951|SUPERIORITY||LS mean difference|-10.5|STANDARD_ERROR_OF_MEAN|4.14||0.0208|TWO_SIDED|80.0|-15.99|-4.98||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 1||-4.98|-15.99|0.0208
72447797|NCT03858634|144412951|SUPERIORITY||LS mean difference|-16.2|STANDARD_ERROR_OF_MEAN|23.54||0.5413|TWO_SIDED|80.0|-54.74|22.38||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 2||22.38|-54.74|0.5413
72447798|NCT03858634|144412951|SUPERIORITY||LS mean difference|17.5|STANDARD_ERROR_OF_MEAN|12.22||0.1683|TWO_SIDED|80.0|1.28|33.74||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 2||33.74|1.28|0.1683
72447799|NCT03858634|144412951|SUPERIORITY||LS mean difference|-58.8|STANDARD_ERROR_OF_MEAN|54.45||0.3933|TWO_SIDED|80.0|-161.43|43.89||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 2||43.89|-161.43|0.3933
72447800|NCT03858634|144412951|SUPERIORITY||LS mean difference|-5.7|STANDARD_ERROR_OF_MEAN|6.25||0.3705|TWO_SIDED|80.0|-14.06|2.58||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 2||2.58|-14.06|0.3705
72447801|NCT03858634|144412951|SUPERIORITY||LS mean difference|-23.0|STANDARD_ERROR_OF_MEAN|35.63||0.5644|TWO_SIDED|80.0|-81.36|35.34||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 3||35.34|-81.36|0.5644
72619408|NCT01370642|144769642|SUPERIORITY_OR_OTHER||Adjusted Difference in Percentages|17.8|||<|0.001|TWO_SIDED|95.0|9.3|27.8|||Miettinen and Nurminen method|||To compare the percentage of participants achieving undetectable HCV RNA at EOT between the vaniprevir and control arms, 95% confidence intervals and corresponding p-values for the between-treatment difference (vaniprevir - control) were computed using Miettinen and Nurminen method stratified by IL28B and age utilizing Cochran-Mantel-Haenszel weights.||27.8|9.3|<0.001
72447802|NCT03858634|144412951|SUPERIORITY||LS mean difference|6.6|STANDARD_ERROR_OF_MEAN|13.82||0.6384|TWO_SIDED|80.0|-11.75|24.94||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 3||24.94|-11.75|0.6384
72447803|NCT03858634|144412951|SUPERIORITY||LS mean difference|-58.6|STANDARD_ERROR_OF_MEAN|58.62||0.4229|TWO_SIDED|80.0|-169.13|51.95||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 3||51.95|-169.13|0.4229
72447804|NCT03858634|144412951|SUPERIORITY||LS mean difference|-16.3|STANDARD_ERROR_OF_MEAN|11.38||0.1688|TWO_SIDED|80.0|-31.47|-1.18||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 3||-1.18|-31.47|0.1688
72447805|NCT03858634|144412951|SUPERIORITY||LS mean difference|-59.6|STANDARD_ERROR_OF_MEAN|28.11||0.1243|TWO_SIDED|80.0|-105.59|-13.53||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 4||-13.53|-105.59|0.1243
72447806|NCT03858634|144412951|SUPERIORITY||LS mean difference|6.9|STANDARD_ERROR_OF_MEAN|16.79||0.6841|TWO_SIDED|80.0|-15.35|29.22||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 4||29.22|-15.35|0.6841
72498390|NCT01264939|144527124|SUPERIORITY_OR_OTHER||Least squares mean difference|-5.9|||<|0.0001|TWO_SIDED|95.0|-7.72|-4.07||Multiplicity plan applied to the efficacy endpoints provided strong control of the type I error rate at 0.05 level by pre-specifying the hierarchical order of the efficacy endpoint tests.|ANCOVA|Covariates included in the analysis were baseline weekly number of hives score (\< median vs ≥ median) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis was that there was no difference between the placebo and the omalizumab 300 mg groups.||-4.07|-7.72|<0.0001
72447807|NCT03858634|144412951|SUPERIORITY||LS mean difference|-53.4|STANDARD_ERROR_OF_MEAN|49.83||0.3963|TWO_SIDED|80.0|-147.31|40.59||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 4||40.59|-147.31|0.3963
72561474|NCT02754492|144653544|OTHER|A procedure is a success if the subject's platelet product has a residual WBC count of \< 12.0 × 10\^6 for the triple platelet product group, or \< 5.0 × 10\^6 for each transfusable unit . The FDA requirements are met if the lower one-sided 95% confidence interval for the procedure success rate is at least 95%.|Simple Sample Proportion|1.0|STANDARD_ERROR_OF_MEAN|0.0|||ONE_SIDED|95.0|0.968||||||When estimated proportion is 100%, standard error of the mean is estimated as 0.|Up to 350 healthy adult subjects will be enrolled in this study to ensure 93 evaluable single platelet product collections, 93 evaluable double platelet product collections, and 93 evaluable triple platelet product collections. This number was chosen to meet the FDA requirements of at least 95% of platelet units with an acceptable residual WBC level with 95% confidence. With 93 platelet products, this allowed for at most 1 failure.|||0.968|
72619409|NCT01370642|144769643|SUPERIORITY_OR_OTHER||Difference in percentages|4.1||||0.385|TWO_SIDED|95.0|-5.4|13.7|||Miettinen and Nurminen method|||Difference in percentage of participants with ≥1 Tier 1 AEs between vaniprevir and control.||13.7|-5.4|0.385
72447808|NCT03858634|144412951|SUPERIORITY||LS mean difference|-24.1|STANDARD_ERROR_OF_MEAN|11.85||0.0571|TWO_SIDED|80.0|-39.85|-8.32||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 4||-8.32|-39.85|0.0571
72447809|NCT03858634|144412951|SUPERIORITY||LS mean difference|-35.3|STANDARD_ERROR_OF_MEAN|40.32||0.4457|TWO_SIDED|80.0|-101.32|30.73||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 5||30.73|-101.32|0.4457
72447810|NCT03858634|144412951|SUPERIORITY||LS mean difference|4.4|STANDARD_ERROR_OF_MEAN|17.99||0.8075|TWO_SIDED|80.0|-19.44|28.32||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 5||28.32|-19.44|0.8075
72447811|NCT03858634|144412951|SUPERIORITY||LS mean difference|-57.7|STANDARD_ERROR_OF_MEAN|55.75||0.4093|TWO_SIDED|80.0|-162.84|47.4||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 5||47.40|-162.84|0.4093
72447812|NCT03858634|144412951|SUPERIORITY||LS mean difference|-27.6|STANDARD_ERROR_OF_MEAN|13.4||0.0543|TWO_SIDED|80.0|-45.42|-9.76||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 5||-9.76|-45.42|0.0543
72447813|NCT03858634|144412951|SUPERIORITY||LS mean difference|-31.0|STANDARD_ERROR_OF_MEAN|37.75||0.4711|TWO_SIDED|80.0|-92.88|30.78||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 6||30.78|-92.88|0.4711
72447814|NCT03858634|144412951|SUPERIORITY||LS mean difference|13.0|STANDARD_ERROR_OF_MEAN|14.89||0.3925|TWO_SIDED|80.0|-6.74|32.79||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 6||32.79|-6.74|0.3925
72619410|NCT01370642|144769643|SUPERIORITY_OR_OTHER||Difference in percentages|-2.2||||0.67|TWO_SIDED|95.0|-12.6|8.1|||Miettinen and Nurminen method|||Difference in percentage of participants with ≥1 Tier 1 AEs between vaniprevir and control.||8.1|-12.6|0.670
72447815|NCT03858634|144412951|SUPERIORITY||LS mean difference|-48.7|STANDARD_ERROR_OF_MEAN|61.24||0.5095|TWO_SIDED|80.0|-164.22|66.72||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 6||66.72|-164.22|0.5095
72447816|NCT03858634|144412951|SUPERIORITY||LS mean difference|-33.8|STANDARD_ERROR_OF_MEAN|13.22||0.0199|TWO_SIDED|80.0|-51.35|-16.18||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 6||-16.18|-51.35|0.0199
72447817|NCT03858634|144412951|SUPERIORITY||LS mean difference|-42.8|STANDARD_ERROR_OF_MEAN|34.48||0.3029|TWO_SIDED|80.0|-99.26|13.69||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 7||13.69|-99.26|0.3029
72447818|NCT03858634|144412951|SUPERIORITY||LS mean difference|10.9|STANDARD_ERROR_OF_MEAN|12.97||0.4094|TWO_SIDED|80.0|-6.28|28.16||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 7||28.16|-6.28|0.4094
72447819|NCT03858634|144412951|SUPERIORITY||LS mean difference|-49.8|STANDARD_ERROR_OF_MEAN|58.25||0.4828|TWO_SIDED|80.0|-159.63|60.05||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 7||60.05|-159.63|0.4828
72447820|NCT03858634|144412951|SUPERIORITY||LS mean difference|-32.8|STANDARD_ERROR_OF_MEAN|14.66||0.0383|TWO_SIDED|80.0|-52.26|-13.26||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 7||-13.26|-52.26|0.0383
72447821|NCT03858634|144412951|SUPERIORITY||LS mean difference|-26.1|STANDARD_ERROR_OF_MEAN|37.1||0.5322|TWO_SIDED|80.0|-86.66|34.65||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 8||34.65|-86.66|0.5322
72447822|NCT03858634|144412951|SUPERIORITY||LS mean difference|-6.2|STANDARD_ERROR_OF_MEAN|13.71||0.6577|TWO_SIDED|80.0|-24.38|12.03||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 8||12.03|-24.38|0.6577
72447823|NCT03858634|144412951|SUPERIORITY||LS mean difference|-38.3|STANDARD_ERROR_OF_MEAN|67.21||0.6259|TWO_SIDED|80.0|-165.08|88.4||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 8||88.40|-165.08|0.6259
72447824|NCT03858634|144412951|SUPERIORITY||LS mean difference|-35.7|STANDARD_ERROR_OF_MEAN|15.27||0.0312|TWO_SIDED|80.0|-56.01|-15.38||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 8||-15.38|-56.01|0.0312
72447825|NCT03858634|144412951|SUPERIORITY||LS mean difference|-108.3|STANDARD_ERROR_OF_MEAN|18.73||0.0103|TWO_SIDED|80.0|-138.97|-77.61||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 9||-77.61|-138.97|0.0103
72561475|NCT02754492|144653545|OTHER|A procedure is a success if the subject's platelet product has a platelet yield of ≥ 3.0 × 10\^11 for the single platelet product group. The requirements are met if the lower one-sided 95% confidence interval for the procedure success rate is at least 75%.|Simple Sample Proportion|0.989|STANDARD_ERROR_OF_MEAN|0.0107|||ONE_SIDED|95.0|0.95|||||||Up to 350 healthy subjects were enrolled to ensure 93 evaluable single, double, and triple platelet product collections. With 93 platelet products being collected, 16 failures or less was required to show that the proportion of units with an acceptable platelet yield is at least 75% with 95% confidence.|||0.950|
72561476|NCT02754492|144653545|OTHER|A procedure is a success if the subject's platelet product has a platelet yield of ≥ 6.2 × 10\^11 for the double platelet product group. The requirements are met if the lower one-sided 95% confidence interval for the procedure success rate is at least 75%.|Simple Sample Proportion|1.0|STANDARD_ERROR_OF_MEAN|0.0|||ONE_SIDED|95.0|0.968||||||When estimated proportion is 100%, standard error of the mean is estimated as 0.|Up to 350 healthy subjects were enrolled to ensure 93 evaluable single, double, and triple platelet product collections. With 93 platelet products being collected, 16 failures or less was required to show that the proportion of units with an acceptable platelet yield is at least 75% with 95% confidence.|||0.968|
72447826|NCT03858634|144412951|SUPERIORITY||LS mean difference|10.0|STANDARD_ERROR_OF_MEAN|12.43||0.433|TWO_SIDED|80.0|-6.59|26.56||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 9||26.56|-6.59|0.4330
72447827|NCT03858634|144412951|SUPERIORITY||LS mean difference|-37.7|STANDARD_ERROR_OF_MEAN|64.23||0.6165|TWO_SIDED|80.0|-158.82|83.39||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 9||83.39|-158.82|0.6165
72447828|NCT03858634|144412951|SUPERIORITY||LS mean difference|-32.0|STANDARD_ERROR_OF_MEAN|15.13||0.0488|TWO_SIDED|80.0|-52.11|-11.84||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 9||-11.84|-52.11|0.0488
72447829|NCT03858634|144412951|SUPERIORITY||LS mean difference|-19.2|STANDARD_ERROR_OF_MEAN|39.9||0.6636|TWO_SIDED|80.0|-84.53|46.16||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 10||46.16|-84.53|0.6636
72447830|NCT03858634|144412951|SUPERIORITY||LS mean difference|23.9|STANDARD_ERROR_OF_MEAN|11.75||0.0583|TWO_SIDED|80.0|8.18|39.52||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 10||39.52|8.18|0.0583
72447831|NCT03858634|144412951|SUPERIORITY||LS mean difference|-45.1|STANDARD_ERROR_OF_MEAN|54.87||0.4975|TWO_SIDED|80.0|-148.55|58.36||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 10||58.36|-148.55|0.4975
72447832|NCT03858634|144412951|SUPERIORITY||LS mean difference|-30.5|STANDARD_ERROR_OF_MEAN|15.54||0.0653|TWO_SIDED|80.0|-51.17|-9.82||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 10||-9.82|-51.17|0.0653
72447833|NCT03858634|144412951|SUPERIORITY||LS mean difference|-23.4|STANDARD_ERROR_OF_MEAN|43.98||0.6316|TWO_SIDED|80.0|-95.42|48.62||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 11||48.62|-95.42|0.6316
72447834|NCT03858634|144412951|SUPERIORITY||LS mean difference|26.6|STANDARD_ERROR_OF_MEAN|14.68||0.0874|TWO_SIDED|80.0|7.05|46.18||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 11||46.18|7.05|0.0874
72447835|NCT03858634|144412951|SUPERIORITY||LS mean difference|-45.0|STANDARD_ERROR_OF_MEAN|50.39||0.4662|TWO_SIDED|80.0|-139.99|50.03||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 11||50.03|-139.99|0.4662
72447836|NCT03858634|144412951|SUPERIORITY||LS mean difference|-25.6|STANDARD_ERROR_OF_MEAN|15.12||0.1073|TWO_SIDED|80.0|-45.76|-5.51||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 11||-5.51|-45.76|0.1073
72447837|NCT03858634|144412951|SUPERIORITY||LS mean difference|-23.3|STANDARD_ERROR_OF_MEAN|42.31||0.6197|TWO_SIDED|80.0|-92.62|45.96||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 12||45.96|-92.62|0.6197
72447838|NCT03858634|144412951|SUPERIORITY||LS mean difference|20.6|STANDARD_ERROR_OF_MEAN|14.97||0.1868|TWO_SIDED|80.0|0.63|40.55||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 12||40.55|0.63|0.1868
72370000|NCT00505778|144250419|NON_INFERIORITY_OR_EQUIVALENCE|To establish non-inferiority for primary efficacy variable at 2-sided upper confidence bound of 95% with 90% power, 442 patients per treatment group were required to be analyzable for primary efficacy analysis. Assuming 10% enrolled would not be analyzable, 1000 patients would be enrolled. If the 95% confidence interval's upper bound interval for the difference between the Asacol BID and Asacol QD group is \<10%, then non-inferiority of Asacol QD is claimed.|BID-QD Difference in Remission Rates|0.8||||0.5426|TWO_SIDED|95.0|-1.8|3.5|||Cochran-Mantel-Haenszel|Stratified by prior Asacol dose Category||Assumed true remission rate is 70% with no difference in remission rates between QD and BID dosing.The non-inferiority margin used in hypothesis testing was set to 10%.||3.5|-1.8|0.5426
72447839|NCT03858634|144412951|SUPERIORITY||LS mean difference|-55.0|STANDARD_ERROR_OF_MEAN|43.32||0.3321|TWO_SIDED|80.0|-136.65|26.71||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 12||26.71|-136.65|0.3321
72447840|NCT03858634|144412951|SUPERIORITY||LS mean difference|-24.8|STANDARD_ERROR_OF_MEAN|15.67||0.131|TWO_SIDED|80.0|-45.64|-3.95||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 12||-3.95|-45.64|0.1310
72447841|NCT03858634|144412951|SUPERIORITY||LS mean difference|-12.0|STANDARD_ERROR_OF_MEAN|46.49||0.8128|TWO_SIDED|80.0|-88.15|64.13||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 13||64.13|-88.15|0.8128
72447842|NCT03858634|144412951|SUPERIORITY||LS mean difference|24.7|STANDARD_ERROR_OF_MEAN|14.23||0.1004|TWO_SIDED|80.0|5.75|43.69||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 13||43.69|5.75|0.1004
72447843|NCT03858634|144412951|SUPERIORITY||LS mean difference|-62.8|STANDARD_ERROR_OF_MEAN|44.81||0.2962|TWO_SIDED|80.0|-147.28|21.71||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 13||21.71|-147.28|0.2962
72498391|NCT01264939|144527125|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.99|||<|0.0001|TWO_SIDED|95.0|1.47|2.68||Multiplicity plan applied to the efficacy endpoints provided strong control of the type I error rate at 0.05 level by pre-specifying the hierarchical order of the efficacy endpoint tests.|Cox proportional hazards model|Covariates included in the analysis were baseline weekly itch severity score (\< 13 vs ≥ 13) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis was that there was no difference between the placebo and the omalizumab 300 mg groups.||2.68|1.47|<0.0001
72561477|NCT02754492|144653545|OTHER|A procedure is a success if the subject's platelet product has a platelet yield of ≥ 9.3 × 10\^11 for the triple platelet product group. The requirements are met if the lower one-sided 95% confidence interval for the procedure success rate is at least 75%.|Simple Sample Proportion|1.0|STANDARD_ERROR_OF_MEAN|0.0|||ONE_SIDED|95.0|0.968||||||When estimated proportion is 100%, standard error of the mean is estimated as 0.|Up to 350 healthy subjects were enrolled to ensure 93 evaluable single, double, and triple platelet product collections. With 93 platelet products being collected, 16 failures or less was required to show that the proportion of units with an acceptable platelet yield is at least 75% with 95% confidence.|||0.968|
72561478|NCT00687739|144653560|SUPERIORITY|The primary analysis compared the GnRHAG + E2 and GnRHAG + PL groups, pooled across exercise status. It was acknowledged that the inclusion of exercisers could minimize the effects of GnRHAG but would be reflective of the effects of ovarian hormone suppression on sedentary and active women. Differences in changes across time between groups were tested using an analysis of covariance model conditioned on baseline.|||||<|0.05||||||The p value was calculated|ANCOVA|||The primary analysis was the effect of PL vs E2 collapsed across exercise (2-group comparison). The analysis of effects of exercise was exploratory (evaluated within-group changes only).||||<0.05
72447844|NCT03858634|144412951|SUPERIORITY||LS mean difference|-26.5|STANDARD_ERROR_OF_MEAN|16.4||0.1236|TWO_SIDED|80.0|-48.31|-4.67||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 13||-4.67|-48.31|0.1236
72447845|NCT03858634|144412951|SUPERIORITY||LS mean difference|-4.5|STANDARD_ERROR_OF_MEAN|45.55||0.9276|TWO_SIDED|80.0|-79.1|70.11||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 14||70.11|-79.10|0.9276
72447846|NCT03858634|144412951|SUPERIORITY||LS mean difference|19.5|STANDARD_ERROR_OF_MEAN|13.46||0.1657|TWO_SIDED|80.0|1.55|37.45||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 14||37.45|1.55|0.1657
72447847|NCT03858634|144412951|SUPERIORITY||LS mean difference|-58.4|STANDARD_ERROR_OF_MEAN|47.8||0.3461|TWO_SIDED|80.0|-148.54|31.71||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 14||31.71|-148.54|0.3461
72447848|NCT03858634|144412951|SUPERIORITY||LS mean difference|-27.6|STANDARD_ERROR_OF_MEAN|16.51||0.1118|TWO_SIDED|80.0|-49.58|-5.64||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 14||-5.64|-49.58|0.1118
72447849|NCT03858634|144412951|SUPERIORITY||LS mean difference|-18.9|STANDARD_ERROR_OF_MEAN|43.24||0.6912|TWO_SIDED|80.0|-89.75|51.89||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 15||51.89|-89.75|0.6912
72447850|NCT03858634|144412951|SUPERIORITY||LS mean difference|22.9|STANDARD_ERROR_OF_MEAN|13.07||0.0973|TWO_SIDED|80.0|5.5|40.35||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 15||40.35|5.50|0.0973
72447851|NCT03858634|144412951|SUPERIORITY||LS mean difference|-57.7|STANDARD_ERROR_OF_MEAN|40.33||0.289|TWO_SIDED|80.0|-133.72|18.37||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 15||18.37|-133.72|0.2890
72447852|NCT03858634|144412951|SUPERIORITY||LS mean difference|-21.9|STANDARD_ERROR_OF_MEAN|17.68||0.231|TWO_SIDED|80.0|-45.43|1.6||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 15||1.60|-45.43|0.2310
72447853|NCT03858634|144412951|SUPERIORITY||LS mean difference|-12.7|STANDARD_ERROR_OF_MEAN|45.17||0.7967|TWO_SIDED|80.0|-86.69|61.28||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 16||61.28|-86.69|0.7967
72447854|NCT03858634|144412951|SUPERIORITY||LS mean difference|16.5|STANDARD_ERROR_OF_MEAN|14.98||0.2868|TWO_SIDED|80.0|-3.5|36.44||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 16||36.44|-3.50|0.2868
72447855|NCT03858634|144412951|SUPERIORITY||LS mean difference|-64.9|STANDARD_ERROR_OF_MEAN|38.83||0.2369|TWO_SIDED|80.0|-138.08|8.37||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 16||8.37|-138.08|0.2369
72447856|NCT03858634|144412951|SUPERIORITY||LS mean difference|-21.9|STANDARD_ERROR_OF_MEAN|17.34||0.2228|TWO_SIDED|80.0|-44.97|1.17||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 16||1.17|-44.97|0.2228
72447857|NCT03858634|144412951|SUPERIORITY||LS mean difference|-14.9|STANDARD_ERROR_OF_MEAN|47.51||0.774|TWO_SIDED|80.0|-92.74|62.89||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 17||62.89|-92.74|0.7740
72447858|NCT03858634|144412951|SUPERIORITY||LS mean difference|15.1|STANDARD_ERROR_OF_MEAN|14.14||0.3|TWO_SIDED|80.0|-3.74|33.98||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 17||33.98|-3.74|0.3000
72447859|NCT03858634|144412951|SUPERIORITY||LS mean difference|-72.4|STANDARD_ERROR_OF_MEAN|31.37||0.1472|TWO_SIDED|80.0|-131.59|-13.3||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 17||-13.30|-131.59|0.1472
72447860|NCT03858634|144412951|SUPERIORITY||LS mean difference|-12.4|STANDARD_ERROR_OF_MEAN|20.56||0.5536|TWO_SIDED|80.0|-39.77|14.94||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 17||14.94|-39.77|0.5536
72447861|NCT03858634|144412951|SUPERIORITY||LS mean difference|-17.6|STANDARD_ERROR_OF_MEAN|43.65||0.7131|TWO_SIDED|80.0|-89.13|53.84||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 18||53.84|-89.13|0.7131
72447862|NCT03858634|144412951|SUPERIORITY||LS mean difference|13.9|STANDARD_ERROR_OF_MEAN|15.27||0.3762|TWO_SIDED|80.0|-6.49|34.24||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 18||34.24|-6.49|0.3762
72447863|NCT03858634|144412951|SUPERIORITY||LS mean difference|-74.1|STANDARD_ERROR_OF_MEAN|31.37||0.1419|TWO_SIDED|80.0|-133.26|-14.97||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 18||-14.97|-133.26|0.1419
72561479|NCT00687739|144653561|SUPERIORITY||||||<|0.05||||||The p value was calculated|ANCOVA|||The primary analysis was the comparison of within-group changes in the E2 and placebo groups for cortisol AUC in response to Dex/CRH and between-group differences in the changes. Within-group changes and between-group differences in changes were evaluated by linear contrast using an ANCOVA model with adjustment for pre-intervention values of outcomes.||||<0.05
72447864|NCT03858634|144412951|SUPERIORITY||LS mean difference|-11.6|STANDARD_ERROR_OF_MEAN|20.74||0.5817|TWO_SIDED|80.0|-39.22|15.95||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 18||15.95|-39.22|0.5817
72447865|NCT03858634|144412953|SUPERIORITY||LS mean difference|27.7|STANDARD_ERROR_OF_MEAN|55.77||0.6532|TWO_SIDED|80.0|-63.6|119.06||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 1||119.06|-63.60|0.6532
72447866|NCT03858634|144412953|SUPERIORITY||LS mean difference|23.6|STANDARD_ERROR_OF_MEAN|9.23||0.0187|TWO_SIDED|80.0|11.38|35.85||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 1||35.85|11.38|0.0187
72447867|NCT03858634|144412953|SUPERIORITY||LS mean difference|-39.3|STANDARD_ERROR_OF_MEAN|44.53||0.4707|TWO_SIDED|80.0|-123.27|44.68||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 1||44.68|-123.27|0.4707
72447868|NCT03858634|144412953|SUPERIORITY||LS mean difference|-1.8|STANDARD_ERROR_OF_MEAN|4.81||0.7108|TWO_SIDED|80.0|-8.22|4.59||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 1||4.59|-8.22|0.7108
72447869|NCT03858634|144412953|SUPERIORITY||LS mean difference|22.4|STANDARD_ERROR_OF_MEAN|60.36||0.7355|TWO_SIDED|80.0|-76.47|121.23||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 2||121.23|-76.47|0.7355
72447870|NCT03858634|144412953|SUPERIORITY||LS mean difference|16.9|STANDARD_ERROR_OF_MEAN|13.27||0.2167|TWO_SIDED|80.0|-0.66|34.52||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 2||34.52|-0.66|0.2167
72447871|NCT03858634|144412953|SUPERIORITY||LS mean difference|-63.5|STANDARD_ERROR_OF_MEAN|60.8||0.4058|TWO_SIDED|80.0|-178.16|51.13||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 2||51.13|-178.16|0.4058
72447872|NCT03858634|144412953|SUPERIORITY||LS mean difference|-6.4|STANDARD_ERROR_OF_MEAN|6.43||0.3323|TWO_SIDED|80.0|-14.95|2.15||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 2||2.15|-14.95|0.3323
72447873|NCT03858634|144412953|SUPERIORITY||LS mean difference|34.3|STANDARD_ERROR_OF_MEAN|68.11||0.6496|TWO_SIDED|80.0|-77.29|145.8||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 3||145.80|-77.29|0.6496
72447874|NCT03858634|144412953|SUPERIORITY||LS mean difference|13.8|STANDARD_ERROR_OF_MEAN|12.76||0.2925|TWO_SIDED|80.0|-3.12|30.7||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 3||30.70|-3.12|0.2925
72447875|NCT03858634|144412953|SUPERIORITY||LS mean difference|-70.7|STANDARD_ERROR_OF_MEAN|67.98||0.4074|TWO_SIDED|80.0|-198.92|57.46||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 3||57.46|-198.92|0.4074
72447876|NCT03858634|144412953|OTHER||LS mean difference|-15.5|STANDARD_ERROR_OF_MEAN|10.56||0.1584|TWO_SIDED|80.0|-29.6|-1.49||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 3||-1.49|-29.60|0.1584
72561480|NCT00687739|144653562|SUPERIORITY||||||<|0.05||||||The p value was calculated|ANCOVA|||The primary analysis compared the GnRHag+E2 and GnRHag+PL groups, pooled across exercise status. Differences in change over time between groups were tested by using an ANCOVA model, first with treatment group alone, and again adding FM and FFM to the model.||||<0.05
72561481|NCT01653405|144653620|SUPERIORITY||||||<|0.001|||||||Difference in differences|||||||<0.001
72561482|NCT01653405|144653621|SUPERIORITY|||||||0.43|||||||test of differences|||||||0.43
72561483|NCT01653405|144653622|SUPERIORITY||||||<|0.001|||||||difference in differences|||||||<0.001
72619411|NCT01370642|144769643|SUPERIORITY_OR_OTHER||Difference in percentages|-4.1||||0.557|TWO_SIDED|95.0|-17.5|9.5|||Miettinen and Nurminen method|||Difference in percentage of participants with anemia Tier 1 AEs between vaniprevir and control.||9.5|-17.5|0.557
72619412|NCT01370642|144769643|SUPERIORITY_OR_OTHER||Difference in percentages|-12.7||||0.072|TWO_SIDED|95.0|-26.2|1.2|||Miettinen and Nurminen method|||Difference in percentage of participants with anemia Tier 1 AEs between vaniprevir and control.||1.2|-26.2|0.072
72447877|NCT03858634|144412953|SUPERIORITY||LS mean difference|-22.8|STANDARD_ERROR_OF_MEAN|54.04||0.7013|TWO_SIDED|80.0|-111.31|65.69||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 4||65.69|-111.31|0.7013
72447878|NCT03858634|144412953|SUPERIORITY||LS mean difference|13.4|STANDARD_ERROR_OF_MEAN|16.35||0.423|TWO_SIDED|80.0|-8.3|35.05||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 4||35.05|-8.30|0.4230
72447879|NCT03858634|144412953|SUPERIORITY||LS mean difference|-60.6|STANDARD_ERROR_OF_MEAN|57.96||0.4055|TWO_SIDED|80.0|-169.9|48.69||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 4||48.69|-169.90|0.4055
72447880|NCT03858634|144412953|SUPERIORITY||LS mean difference|-22.7|STANDARD_ERROR_OF_MEAN|11.82||0.0709|TWO_SIDED|80.0|-38.41|-6.96||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 4||-6.96|-38.41|0.0709
72447881|NCT03858634|144412953|SUPERIORITY||LS mean difference|17.7|STANDARD_ERROR_OF_MEAN|74.17||0.8268|TWO_SIDED|80.0|-103.77|139.17||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 5||139.17|-103.77|0.8268
72498392|NCT01264939|144527126|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Multiplicity plan applied to the efficacy endpoints provided strong control of the type I error rate at 0.05 level by pre-specifying the hierarchical order of the efficacy endpoint tests.|Cochran-Mantel-Haenszel|Covariates included in the analysis were baseline UAS7 (\< median vs ≥ median) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis was that there was no difference between the placebo and the omalizumab 300 mg groups.||||<0.0001
72498393|NCT01264939|144527127|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Multiplicity plan applied to the efficacy endpoints provided strong control of the type I error rate at 0.05 level by pre-specifying the hierarchical order of the efficacy endpoint tests.|Cochran-Mantel-Haenszel|Covariates included in the analysis were baseline weekly itch severity score (\< 13 vs ≥ 13) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis was that there was no difference between the placebo and the omalizumab 300 mg groups.||||<0.0001
72498394|NCT01264939|144527128|SUPERIORITY_OR_OTHER||Least squares mean difference|-5.61|||<|0.0001|TWO_SIDED|95.0|-7.25|-3.96||Multiplicity plan applied to the efficacy endpoints provided strong control of the type I error rate at 0.05 level by pre-specifying the hierarchical order of the efficacy endpoint tests.|ANCOVA|Covariates included in the analysis were baseline weekly size of largest hive score (\< median vs ≥ median) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis was that there was no difference between the placebo and the omalizumab 300 mg groups.||-3.96|-7.25|<0.0001
72561484|NCT01653405|144653623|SUPERIORITY||||||<|0.001|||||||Difference in differences|||||||<0.001
72561485|NCT01653405|144653624|SUPERIORITY|||||||0.002|||||||difference in differences|||||||0.002
72561486|NCT03174158|144653625|SUPERIORITY|||||||0.07||||||a priori p value threshold \< 0.05|Chi-squared|||||||0.07
72561487|NCT03174158|144653625|SUPERIORITY|||||||0.18|||||||Chi-squared|a priori threshold p\<0.05||||||0.18
72561488|NCT03174158|144653625|SUPERIORITY|||||||0.21||||||a priori threshold p\<0.05|Chi-squared|||||||0.21
72561489|NCT00372996|144653642|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.912||||0.56|TWO_SIDED|80.0|0.744|1.118|||Log Rank|2-sided p-value from an unstratified log-rank text|Hazard ratio was based on Cox proportional hazards model.|||1.118|0.744|0.560
72561490|NCT00372996|144653643|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.764||||0.331|TWO_SIDED|70.0|0.572|1.02||2-sided p-value from unstratified log-rank test|Log Rank||Hazard ratio was based on the Cox proportional hazards model.|||1.020|0.572|0.331
72561491|NCT00372996|144653644|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.79||||0.463|TWO_SIDED|95.0|-8.0|17.6|||Pearson chi-square test|||||17.6|-8.0|0.463
72561492|NCT02151149|144653656|SUPERIORITY||Risk Ratio (RR)|1.01||||0.9258|TWO_SIDED|95.0|0.84|1.21|||Cochran-Mantel-Haenszel|Based on stratification factors of ECOG PS at screening (0 vs. 1) and histology (squamous cell carcinoma vs. non-squamous cell carcinoma).||||1.21|0.84|0.9258
72561493|NCT02151149|144653663|SUPERIORITY||Hazard Ratio (HR)|0.52||||0.0036|TWO_SIDED|95.0|0.33|0.81|||Stratified Log Rank|Based on stratification factors of ECOG PS at screening (0 vs. 1) and histology (squamous cell carcinoma vs. non-squamous cell carcinoma).||||0.81|0.33|0.0036
72561494|NCT02151149|144653664|SUPERIORITY||Hazard Ratio (HR)|0.82||||0.3537|TWO_SIDED|95.0|0.54|1.25|||Stratified log-rank test|Based on stratification factors of ECOG PS at screening (0 vs. 1) and histology (squamous cell carcinoma vs. non-squamous cell carcinoma).||||1.25|0.54|0.3537
72561495|NCT02151149|144653665|SUPERIORITY||Risk Ratio (RR)|1.56||||0.0597|TWO_SIDED|95.0|0.971|2.511|||Cochran-Mantel-Haenszel|Based on stratification factors of ECOG PS at screening (0 vs. 1) and histology (squamous cell carcinoma vs. non-squamous cell carcinoma)..||||2.511|0.971|0.0597
72619413|NCT01370642|144769643|SUPERIORITY_OR_OTHER||Difference in percentages|0.0|||>|0.999|TWO_SIDED|95.0|-7.9|7.9|||Miettinen and Nurminen method|||Difference in percentage of participants with bilirubin increased Tier 1 AEs between vaniprevir and control.||7.9|-7.9|>0.999
72619414|NCT01370642|144769643|SUPERIORITY_OR_OTHER||Difference in percentages|5.2||||0.22|TWO_SIDED|95.0|-3.3|14.2|||Miettinen and Nurminen method|||Difference in percentage of participants with bilirubin increased Tier 1 AEs between vaniprevir and control.||14.2|-3.3|0.220
72619415|NCT01370642|144769643|SUPERIORITY_OR_OTHER||Difference in percentages|15.3||||0.032|TWO_SIDED|95.0|1.3|28.7|||Miettinen and Nurminen method|||Difference in percentage of participants with GI Tier 1 AEs between vaniprevir and control.||28.7|1.3|0.032
72619416|NCT01370642|144769643|SUPERIORITY_OR_OTHER||Difference in percentages|5.6||||0.432|TWO_SIDED|95.0|-8.4|19.4|||Miettinen and Nurminen method|||Difference in percentage of participants with GI Tier 1 AEs between vaniprevir and control.||19.4|-8.4|0.432
72619417|NCT01370642|144769643|SUPERIORITY_OR_OTHER||Difference in percentages|8.2||||0.252|TWO_SIDED|95.0|-5.8|21.8|||Miettinen and Nurminen method|||Difference in percentage of participants with neutropenia Tier 1 AEs between vaniprevir and control.||21.8|-5.8|0.252
72561496|NCT02760433|144653666|SUPERIORITY||Risk Difference (RD)|0.19||||0.004|TWO_SIDED|97.5|0.03|0.337|||Chi-squared|2x2 chi-square test||The ACR20 response rate at Week 12 for the placebo group is estimated to be 20% in this study population. The OKZ ACR20 response rate for 64 mg q4w treatment group at Week 12 are expected to be at least 45%, resulting in an expected difference in ACR20 response rates of 25 percentage points between the respective OKZ treatment group and placebo. Sample size yield 100% disjunctive power for testing the primary hypothesis||0.337|0.030|0.004
72561497|NCT02760433|144653666|SUPERIORITY||Risk Difference (RD)|0.203||||0.0029|TWO_SIDED|97.5|0.038|0.353|||Chi-squared|2x2 chi-square test||The ACR20 response rate at Week 12 for the placebo group is estimated to be 20% in this study population .The OKZ ACR20 response rate for 64 mg q2w treatment group at Week 12 is expected to be at least 50%, resulting in an expected difference in ACR20 response rates of 30 percentage points between the respective OKZ treatment group and placebo. Sample size yield 100% disjunctive power for testing the primary hypothesis||0.353|0.038|0.0029
72619418|NCT01370642|144769643|SUPERIORITY_OR_OTHER||Difference in percentages|0.5||||0.942|TWO_SIDED|95.0|-13.4|14.4|||Miettinen and Nurminen method|||Difference in percentage of participants with neutropenia Tier 1 AEs between vaniprevir and control.||14.4|-13.4|0.942
72619419|NCT01370642|144769644|SUPERIORITY_OR_OTHER||LS Mean Difference at Week 2|-3.2|||||TWO_SIDED|95.0|-3.5|-3.0|||Constrained LDA Model|||Change from BL in HCV RNA at Week 2 was computed using a constrained longitudinal data analysis model including treatment, time and the interaction of time by treatment with a restriction of the same baseline mean across treatment groups as well as adjusting for IL28B and age, and their interaction terms with time will be included in the model.||-3.0|-3.5|
72619420|NCT01370642|144769644|SUPERIORITY_OR_OTHER||LS Mean Difference at Week 2|-3.5|||||TWO_SIDED|95.0|-3.7|-3.2|||Constrained LDA Model|||Change from BL in HCV RNA at Week 2 was computed using a constrained longitudinal data analysis model including treatment, time and the interaction of time by treatment with a restriction of the same baseline mean across treatment groups as well as adjusting for IL28B and age, and their interaction terms with time will be included in the model.||-3.2|-3.7|
72619421|NCT01370642|144769644|SUPERIORITY_OR_OTHER||LS Mean Difference at Week 4|-3.0|||||TWO_SIDED|95.0|-3.3|-2.7|||Constrained LDA Model|||Change from BL in HCV RNA at Week 4 was computed using a constrained longitudinal data analysis model including treatment, time and the interaction of time by treatment with a restriction of the same baseline mean across treatment groups as well as adjusting for IL28B and age, and their interaction terms with time will be included in the model.||-2.7|-3.3|
72370178|NCT03085797|144250807|SUPERIORITY||Difference in Medians|-0.73|||<|0.001|TWO_SIDED|95.0|-1.11|-0.34||p-Value was based on Wilcoxon rank-sum test.|Wilcoxon rank-sum test||Quantile regression with covariates: treatment,region,Baseline score,Baseline eosinophilcount(BEC). Par. with nasal surgery prior to Wk52/withdrew early with no nasal surgery assigned their worst observed score prior to nasal surgery/study withdrawal|||-0.34|-1.11|<0.001
72447882|NCT03858634|144412953|SUPERIORITY||LS mean difference|12.4|STANDARD_ERROR_OF_MEAN|14.63||0.4082|TWO_SIDED|80.0|-7.03|31.75||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 5||31.75|-7.03|0.4082
72447883|NCT03858634|144412953|SUPERIORITY||LS mean difference|-50.4|STANDARD_ERROR_OF_MEAN|58.86||0.4818|TWO_SIDED|80.0|-161.43|60.56||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 5||60.56|-161.43|0.4818
72447884|NCT03858634|144412953|SUPERIORITY||LS mean difference|-27.1|STANDARD_ERROR_OF_MEAN|13.93||0.0673|TWO_SIDED|80.0|-45.64|-8.58||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 5||-8.58|-45.64|0.0673
72498395|NCT01264939|144527129|SUPERIORITY_OR_OTHER||Least squares mean difference|-4.67|||<|0.0001|TWO_SIDED|95.0|-6.28|-3.06||Multiplicity plan applied to the efficacy endpoints provided strong control of the type I error rate at 0.05 level by pre-specifying the hierarchical order of the efficacy endpoint tests.|ANCOVA|Covariates included in the analysis were baseline overall DLQI score (\< median vs ≥ median) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis was that there was no difference between the placebo and the omalizumab 300 mg groups.||-3.06|-6.28|<0.0001
72447885|NCT03858634|144412953|SUPERIORITY||LS mean difference|29.6|STANDARD_ERROR_OF_MEAN|82.15||0.7429|TWO_SIDED|80.0|-105.0|164.1||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 6||164.10|-105.00|0.7429
72447886|NCT03858634|144412953|SUPERIORITY||LS mean difference|21.8|STANDARD_ERROR_OF_MEAN|13.55||0.1227|TWO_SIDED|80.0|3.88|39.79||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 6||39.79|3.88|0.1227
72619422|NCT01370642|144769644|SUPERIORITY_OR_OTHER||LS Mean Difference at Week 4|-3.1|||||TWO_SIDED|95.0|-3.4|-2.8|||Constrained LDA Model|||Change from BL in HCV RNA at Week 4 was computed using a constrained longitudinal data analysis model including treatment, time and the interaction of time by treatment with a restriction of the same baseline mean across treatment groups as well as adjusting for IL28B and age, and their interaction terms with time will be included in the model.||-2.8|-3.4|
72619423|NCT01370642|144769644|SUPERIORITY_OR_OTHER||LS Mean Difference at Week 8|-1.9|||||TWO_SIDED|95.0|-2.2|-1.6|||Constrained LDA Model|||Change from BL in HCV RNA at Week 8 was computed using a constrained longitudinal data analysis model including treatment, time and the interaction of time by treatment with a restriction of the same baseline mean across treatment groups as well as adjusting for IL28B and age, and their interaction terms with time will be included in the model.||-1.6|-2.2|
72619424|NCT01370642|144769644|SUPERIORITY_OR_OTHER||LS Mean Difference at Week 8|-2.0|||||TWO_SIDED|95.0|-2.3|-1.7|||Constrained LDA Model|||Change from BL in HCV RNA at Week 8 was computed using a constrained longitudinal data analysis model including treatment, time and the interaction of time by treatment with a restriction of the same baseline mean across treatment groups as well as adjusting for IL28B and age, and their interaction terms with time will be included in the model.||-1.7|-2.3|
72619425|NCT01370642|144769644|SUPERIORITY_OR_OTHER||LS Mean Difference at Week 12|-1.4|||||TWO_SIDED|95.0|-1.7|-1.1|||Constrained LDA Model|||Change from BL in HCV RNA at Week 12 was computed using a constrained longitudinal data analysis model including treatment, time and the interaction of time by treatment with a restriction of the same baseline mean across treatment groups as well as adjusting for IL28B and age, and their interaction terms with time will be included in the model.||-1.1|-1.7|
72561498|NCT02760433|144653667|SUPERIORITY||Risk Difference (RD)|0.176||||0.0021|TWO_SIDED|97.5|0.041|0.281|||Chi-squared|2x2 chi-square test||The DAS28 low disease activity (based on DAS28 \[CRP\] \<3.2) response rate at Week 12 was estimated to be 5% in the placebo group and 18% and 21% in 64 mg q4w and q2w OKZ groups, respectively, resulting in an expected difference of 13 and 16 percentage points between respective OKZ groups and placebo.||0.281|0.041|0.0021
72370179|NCT03085797|144250808|SUPERIORITY||Difference in Medians|-3.14|||<|0.001|TWO_SIDED|95.0|-4.09|-2.18||p-Value was based on Wilcoxon rank-sum test.|Wilcoxon rank-sum test||Quantile regression with covariates: treatment, region, Baseline score, Baseline BEC. Par. with nasal surgery prior to Wks 49-52/withdrew early with no nasal surgery assigned their worst observed 4-wk mean prior to nasal surgery/study withdrawal.|||-2.18|-4.09|<0.001
72447887|NCT03858634|144412953|SUPERIORITY||LS mean difference|-47.5|STANDARD_ERROR_OF_MEAN|58.06||0.4996|TWO_SIDED|80.0|-156.95|62.02||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 6||62.02|-156.95|0.4996
72447888|NCT03858634|144412953|SUPERIORITY||LS mean difference|-33.6|STANDARD_ERROR_OF_MEAN|13.69||0.0244|TWO_SIDED|80.0|-51.87|-15.43||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 6||-15.43|-51.87|0.0244
72447889|NCT03858634|144412953|SUPERIORITY||LS mean difference|-0.3|STANDARD_ERROR_OF_MEAN|64.24||0.9967|TWO_SIDED|80.0|-105.5|104.92||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 7||104.92|-105.50|0.9967
72447890|NCT03858634|144412953|SUPERIORITY||LS mean difference|19.1|STANDARD_ERROR_OF_MEAN|13.57||0.1739|TWO_SIDED|80.0|1.15|37.12||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 7||37.12|1.15|0.1739
72447891|NCT03858634|144412953|SUPERIORITY||LS mean difference|-55.1|STANDARD_ERROR_OF_MEAN|51.61||0.3978|TWO_SIDED|80.0|-152.39|42.26||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 7||42.26|-152.39|0.3978
72447892|NCT03858634|144412953|SUPERIORITY||LS mean difference|-32.7|STANDARD_ERROR_OF_MEAN|14.73||0.0397|TWO_SIDED|80.0|-52.26|-13.07||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 7||-13.07|-52.26|0.0397
72447893|NCT03858634|144412953|SUPERIORITY||LS mean difference|10.4|STANDARD_ERROR_OF_MEAN|70.66||0.8922|TWO_SIDED|80.0|-105.32|126.14||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 8||126.14|-105.32|0.8922
72447894|NCT03858634|144412953|SUPERIORITY||LS mean difference|17.3|STANDARD_ERROR_OF_MEAN|14.43||0.2439|TWO_SIDED|80.0|-1.8|36.45||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 8||36.45|-1.80|0.2439
72447895|NCT03858634|144412953|SUPERIORITY||LS mean difference|-50.3|STANDARD_ERROR_OF_MEAN|37.1||0.3076|TWO_SIDED|80.0|-120.29|19.61||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 8||19.61|-120.29|0.3076
72561499|NCT02760433|144653667|SUPERIORITY||Risk Difference (RD)|0.283|||<|0.0001|TWO_SIDED|97.5|0.139|0.396|||Chi-squared|2x2 chi-square test||The DAS28 low disease activity (based on DAS28 \[CRP\] \<3.2) response rate at Week 12 was estimated to be 5% in the placebo group and 18% and 21% in 64 mg q4w and q2w OKZ groups, respectively, resulting in an expected difference of 13 and 16 percentage points between respective OKZ groups and placebo.||0.396|0.139|<0.0001
72561500|NCT02760433|144653668|SUPERIORITY||Least Squares Mean Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.081|=|0.1814|TWO_SIDED|97.5|-0.26|0.11||p-value was greater than the threshold p-value of 0.0125|ANCOVA|||||0.11|-0.26|=0.1814
72447896|NCT03858634|144412953|SUPERIORITY||LS mean difference|-36.4|STANDARD_ERROR_OF_MEAN|15.7||0.0322|TWO_SIDED|80.0|-57.32|-15.55||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 8||-15.55|-57.32|0.0322
72447897|NCT03858634|144412953|SUPERIORITY||LS mean difference|-94.7|STANDARD_ERROR_OF_MEAN|27.67||0.0418|TWO_SIDED|80.0|-139.98|-49.36||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 9||-49.36|-139.98|0.0418
72447898|NCT03858634|144412953|SUPERIORITY||LS mean difference|24.4|STANDARD_ERROR_OF_MEAN|13.44||0.0865|TWO_SIDED|80.0|6.49|42.26||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 9||42.26|6.49|0.0865
72447899|NCT03858634|144412953|SUPERIORITY||LS mean difference|-48.9|STANDARD_ERROR_OF_MEAN|40.32||0.3489|TWO_SIDED|80.0|-124.96|27.11||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 9||27.11|-124.96|0.3489
72447900|NCT03858634|144412953|SUPERIORITY||LS mean difference|-38.1|STANDARD_ERROR_OF_MEAN|15.99||0.0286|TWO_SIDED|80.0|-59.34|-16.79||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 9||-16.79|-59.34|0.0286
72447901|NCT03858634|144412953|SUPERIORITY||LS mean difference|28.6|STANDARD_ERROR_OF_MEAN|72.63||0.7198|TWO_SIDED|80.0|-90.32|147.59||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 10||147.59|-90.32|0.7198
72447902|NCT03858634|144412953|SUPERIORITY||LS mean difference|39.0|STANDARD_ERROR_OF_MEAN|13.27||0.0088|TWO_SIDED|80.0|21.32|56.63||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 10||56.63|21.32|0.0088
72447903|NCT03858634|144412953|SUPERIORITY||LS mean difference|-56.5|STANDARD_ERROR_OF_MEAN|33.87||0.2371|TWO_SIDED|80.0|-120.39|7.34||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 10||7.34|-120.39|0.2371
72447904|NCT03858634|144412953|SUPERIORITY||LS mean difference|-40.8|STANDARD_ERROR_OF_MEAN|16.14||0.021|TWO_SIDED|80.0|-62.3|-19.35||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 10||-19.35|-62.30|0.0210
72447905|NCT03858634|144412953|SUPERIORITY||LS mean difference|20.4|STANDARD_ERROR_OF_MEAN|54.07||0.7312|TWO_SIDED|80.0|-68.17|108.94||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 11||108.94|-68.17|0.7312
72447906|NCT03858634|144412953|SUPERIORITY||LS mean difference|39.4|STANDARD_ERROR_OF_MEAN|14.64||0.015|TWO_SIDED|80.0|19.88|58.83||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 11||58.83|19.88|0.0150
72561501|NCT02760433|144653668|SUPERIORITY||Least Squares Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.083|=|0.0227|TWO_SIDED|97.5|-0.35|0.02||p-value was greater than the threshold p-value of 0.0125|ANCOVA|||||0.02|-0.35|=0.0227
72561502|NCT02760433|144653669|SUPERIORITY||Risk Difference (RD)|0.164|||||TWO_SIDED|97.5|0.02|0.278||Due to the hierarchical nature of pre-planned statistical testing (gate-keeping strategy) a formal statement could not be made||||||0.278|0.020|
72561503|NCT02760433|144653669|SUPERIORITY||Risk Difference (RD)|0.174|||||TWO_SIDED|97.5|0.027|0.294||Due to the hierarchical nature of pre-planned statistical testing (gate-keeping strategy) a formal statement could not be made||||||0.294|0.027|
72447907|NCT03858634|144412953|SUPERIORITY||LS mean difference|-53.3|STANDARD_ERROR_OF_MEAN|33.87||0.2559|TWO_SIDED|80.0|-117.22|10.52||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 11||10.52|-117.22|0.2559
72447908|NCT03858634|144412953|SUPERIORITY||LS mean difference|-35.0|STANDARD_ERROR_OF_MEAN|15.97||0.0419|TWO_SIDED|80.0|-56.21|-13.72||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 11||-13.72|-56.21|0.0419
72447909|NCT03858634|144412953|SUPERIORITY||LS mean difference|20.4|STANDARD_ERROR_OF_MEAN|60.66||0.7589|TWO_SIDED|80.0|-78.95|119.74||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 12||119.74|-78.95|0.7589
72447910|NCT03858634|144412953|SUPERIORITY||LS mean difference|39.1|STANDARD_ERROR_OF_MEAN|17.42||0.0374|TWO_SIDED|80.0|15.97|62.31||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 12||62.31|15.97|0.0374
72447911|NCT03858634|144412953|SUPERIORITY||LS mean difference|-54.9|STANDARD_ERROR_OF_MEAN|33.87||0.2463|TWO_SIDED|80.0|-118.8|8.93||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 12||8.93|-118.80|0.2463
72447912|NCT03858634|144412953|SUPERIORITY||LS mean difference|-33.2|STANDARD_ERROR_OF_MEAN|16.78||0.0632|TWO_SIDED|80.0|-55.56|-10.9||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 12||-10.90|-55.56|0.0632
72447913|NCT03858634|144412953|SUPERIORITY||LS mean difference|25.7|STANDARD_ERROR_OF_MEAN|61.73||0.7053|TWO_SIDED|80.0|-75.41|126.78||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 13||126.78|-75.41|0.7053
72447914|NCT03858634|144412953|SUPERIORITY||LS mean difference|38.7|STANDARD_ERROR_OF_MEAN|16.25||0.0285|TWO_SIDED|80.0|17.09|60.34||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 13||60.34|17.09|0.0285
72447915|NCT03858634|144412953|SUPERIORITY||LS mean difference|-64.6|STANDARD_ERROR_OF_MEAN|37.1||0.2236|TWO_SIDED|80.0|-134.58|5.32||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 13||5.32|-134.58|0.2236
72447916|NCT03858634|144412953|OTHER||LS mean difference|-35.5|STANDARD_ERROR_OF_MEAN|17.38||0.0558|TWO_SIDED|80.0|-58.65|-12.41||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 13||-12.41|-58.65|0.0558
72447917|NCT03858634|144412953|SUPERIORITY||LS mean difference|29.9|STANDARD_ERROR_OF_MEAN|72.86||0.7089|TWO_SIDED|80.0|-89.41|149.24||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 14||149.24|-89.41|0.7089
72447918|NCT03858634|144412953|SUPERIORITY||LS mean difference|33.7|STANDARD_ERROR_OF_MEAN|14.76||0.0347|TWO_SIDED|80.0|14.08|53.35||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 14||53.35|14.08|0.0347
72447919|NCT03858634|144412953|SUPERIORITY||LS mean difference|-60.9|STANDARD_ERROR_OF_MEAN|41.94||0.2835|TWO_SIDED|80.0|-139.99|18.16||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 14||18.16|-139.99|0.2835
72561504|NCT02760433|144653670|SUPERIORITY||Risk Difference (RD)|0.031|||||TWO_SIDED|97.5|-0.052|0.083||Due to the hierarchical nature of pre-planned statistical testing (gate-keeping strategy) a formal statement could not be made|||means continuity correction applied because expected cell counts \< 5|||0.083|-0.052|
72561505|NCT02760433|144653670|SUPERIORITY||Risk Difference (RD)|0.065|||||TWO_SIDED|97.5|-0.023|0.134||Due to the hierarchical nature of pre-planned statistical testing (gate-keeping strategy) a formal statement could not be made|||means continuity correction applied because expected cell counts \< 5|||0.134|-0.023|
72561506|NCT01881737|144653697|SUPERIORITY_OR_OTHER|||||||0.848|||||||Paired t test|||Effect Size Cohen's d = -0.05||||0.848
72561507|NCT01881737|144653698|SUPERIORITY_OR_OTHER|||||||0.009|||||||Paired t test|Effect Size Cohen's d = 0.53||||||0.009
72447920|NCT03858634|144412953|SUPERIORITY||LS mean difference|-35.5|STANDARD_ERROR_OF_MEAN|17.11||0.0525|TWO_SIDED|80.0|-58.31|-12.77||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 14||-12.77|-58.31|0.0525
72447921|NCT03858634|144412953|SUPERIORITY||LS mean difference|24.0|STANDARD_ERROR_OF_MEAN|64.52||0.7347|TWO_SIDED|80.0|-81.68|129.66||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 15||129.66|-81.68|0.7347
72447922|NCT03858634|144412953|SUPERIORITY||LS mean difference|31.0|STANDARD_ERROR_OF_MEAN|13.94||0.039|TWO_SIDED|80.0|12.5|49.6||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 15||49.60|12.50|0.0390
72561508|NCT01881737|144653699|SUPERIORITY_OR_OTHER|||||||0.38|||||||paired t test|Effect size Cohen's d = 0.38||||||0.38
72561509|NCT01881737|144653701|SUPERIORITY_OR_OTHER|||||||0.0001|||||||t-test, 2 sided|||||||0.0001
72561510|NCT02102932|144653702|SUPERIORITY_OR_OTHER||Ratio of the geometric means|105.29|STANDARD_DEVIATION|6.6||0|TWO_SIDED|90.0|101.92|108.78||P-value for ratio outside interval 80-125|ANOVA||Ratio of the geometric means for treatments (Test (T1) versus Reference (R1)) i.e. T1/R1. The standard deviation is actually the intra-individual gCV.|"The statistical model used was an analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation:~'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed."||108.78|101.92|0.0000
72447923|NCT03858634|144412953|SUPERIORITY||LS mean difference|-60.6|STANDARD_ERROR_OF_MEAN|35.48||0.2299|TWO_SIDED|80.0|-127.49|6.33||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 15||6.33|-127.49|0.2299
72370180|NCT03085797|144250809|SUPERIORITY||Hazard Ratio (Mepolizumab/Placebo)|0.43||||0.003|TWO_SIDED|95.0|0.25|0.76||p-Value was based on Cox Proportional Hazards Model.|Cox Proportional Hazards Model||Analysis using a Cox Proportional Hazards Model with covariates of treatment, geographic region, Baseline total endoscopic score (centrally read), Baseline nasal obstruction VAS, Baseline BEC, number of previous surgeries (1, 2, \>2 as ordinal).|||0.76|0.25|0.003
72447924|NCT03858634|144412953|SUPERIORITY||LS mean difference|-32.6|STANDARD_ERROR_OF_MEAN|18.11||0.0884|TWO_SIDED|80.0|-56.7|-8.53||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 15||-8.53|-56.70|0.0884
72447925|NCT03858634|144412953|SUPERIORITY||LS mean difference|16.3|STANDARD_ERROR_OF_MEAN|61.44||0.8085|TWO_SIDED|80.0|-84.37|116.87||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 16||116.87|-84.37|0.8085
72447926|NCT03858634|144412953|SUPERIORITY||LS mean difference|19.9|STANDARD_ERROR_OF_MEAN|15.96||0.2283|TWO_SIDED|80.0|-1.33|41.14||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 16||41.14|-1.33|0.2283
72447927|NCT03858634|144412953|SUPERIORITY||LS mean difference|-69.9|STANDARD_ERROR_OF_MEAN|32.26||0.1625|TWO_SIDED|80.0|-130.76|-9.11||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 16||-9.11|-130.76|0.1625
72447928|NCT03858634|144412953|SUPERIORITY||LS mean difference|-34.2|STANDARD_ERROR_OF_MEAN|17.8||0.0707|TWO_SIDED|80.0|-57.87|-10.52||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 16||-10.52|-57.87|0.0707
72447929|NCT03858634|144412953|SUPERIORITY||LS mean difference|0.4|STANDARD_ERROR_OF_MEAN|50.17||0.9944|TWO_SIDED|80.0|-81.79|82.55||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 17||82.55|-81.79|0.9944
72447930|NCT03858634|144412953|SUPERIORITY||LS mean difference|23.9|STANDARD_ERROR_OF_MEAN|15.16||0.1327|TWO_SIDED|80.0|3.71|44.05||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 17||44.05|3.71|0.1327
72447931|NCT03858634|144412953|SUPERIORITY||LS mean difference|-69.2|STANDARD_ERROR_OF_MEAN|33.87||0.1777|TWO_SIDED|80.0|-133.09|-5.35||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 17||-5.35|-133.09|0.1777
72447932|NCT03858634|144412953|SUPERIORITY||LS mean difference|-23.9|STANDARD_ERROR_OF_MEAN|21.4||0.2796|TWO_SIDED|80.0|-52.34|4.61||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 17||4.61|-52.34|0.2796
72447933|NCT03858634|144412953|SUPERIORITY||LS mean difference|7.6|STANDARD_ERROR_OF_MEAN|55.4||0.8999|TWO_SIDED|80.0|-83.15|98.3||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 18||98.30|-83.15|0.8999
72447934|NCT03858634|144412953|SUPERIORITY||LS mean difference|22.0|STANDARD_ERROR_OF_MEAN|15.99||0.1867|TWO_SIDED|80.0|0.68|43.23||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 18||43.23|0.68|0.1867
72447935|NCT03858634|144412953|SUPERIORITY||LS mean difference|-70.8|STANDARD_ERROR_OF_MEAN|33.87||0.1717|TWO_SIDED|80.0|-134.68|-6.94||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 18||-6.94|-134.68|0.1717
72447936|NCT03858634|144412953|SUPERIORITY||LS mean difference|-23.9|STANDARD_ERROR_OF_MEAN|21.46||0.2792|TWO_SIDED|80.0|-52.5|4.61||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 18||4.61|-52.50|0.2792
72447937|NCT03858634|144412955|SUPERIORITY||LS Mean Difference|-47.3|STANDARD_ERROR_OF_MEAN|31.41||0.2289|TWO_SIDED|80.0|-98.77|4.1||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 4||4.10|-98.77|0.2289
72447938|NCT03858634|144412955|SUPERIORITY||LS Mean Difference|19.6|STANDARD_ERROR_OF_MEAN|14.08||0.1788|TWO_SIDED|80.0|0.96|38.27||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 4||38.27|0.96|0.1788
72447939|NCT03858634|144412955|SUPERIORITY||LS Mean Difference|-59.6|STANDARD_ERROR_OF_MEAN|114.35||0.6544|TWO_SIDED|80.0|-275.19|156.06||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 4||156.06|-275.19|0.6544
72447940|NCT03858634|144412955|SUPERIORITY||LS Mean Difference|-72.2|STANDARD_ERROR_OF_MEAN|20.4||0.0023|TWO_SIDED|80.0|-99.39|-45.09||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 4||-45.09|-99.39|0.0023
72447941|NCT03858634|144412955|SUPERIORITY||LS Mean Difference|-52.1|STANDARD_ERROR_OF_MEAN|22.96||0.1081|TWO_SIDED|80.0|-89.68|-14.47||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 8||-14.47|-89.68|0.1081
72447942|NCT03858634|144412955|SUPERIORITY||LS Mean Difference|14.9|STANDARD_ERROR_OF_MEAN|21.37||0.4926|TWO_SIDED|80.0|-13.39|43.26||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 8||43.26|-13.39|0.4926
72447943|NCT03858634|144412955|SUPERIORITY||LS Mean Difference|53.2|STANDARD_ERROR_OF_MEAN|219.98||0.8315|TWO_SIDED|80.0|-361.63|467.98||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 8||467.98|-361.63|0.8315
72447944|NCT03858634|144412955|SUPERIORITY||LS Mean Difference|-69.9|STANDARD_ERROR_OF_MEAN|18.56||0.0014|TWO_SIDED|80.0|-94.61|-45.22||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 8||-45.22|-94.61|0.0014
72447945|NCT03858634|144412955|SUPERIORITY||LS Mean Difference|-52.1|STANDARD_ERROR_OF_MEAN|22.96||0.1081|TWO_SIDED|80.0|-89.68|-14.47||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 12||-14.47|-89.68|0.1081
72447946|NCT03858634|144412955|SUPERIORITY||LS Mean Difference|7.6|STANDARD_ERROR_OF_MEAN|21.97||0.7339|TWO_SIDED|80.0|-21.65|36.82||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 12||36.82|-21.65|0.7339
72619426|NCT01370642|144769644|SUPERIORITY_OR_OTHER||LS Mean Difference at Week 12|-1.4|||||TWO_SIDED|95.0|-1.7|-1.1|||Constrained LDA Model|||Change from BL in HCV RNA at Week 12 was computed using a constrained longitudinal data analysis model including treatment, time and the interaction of time by treatment with a restriction of the same baseline mean across treatment groups as well as adjusting for IL28B and age, and their interaction terms with time will be included in the model.||-1.1|-1.7|
72619427|NCT01370642|144769644|SUPERIORITY_OR_OTHER||LS Mean Difference at Week 24|-0.8|||||TWO_SIDED|95.0|-1.1|-0.5|||Constrained LDA Model|||Change from BL in HCV RNA at Week 24 was computed using a constrained longitudinal data analysis model including treatment, time and the interaction of time by treatment with a restriction of the same baseline mean across treatment groups as well as adjusting for IL28B and age, and their interaction terms with time will be included in the model.||-0.5|-1.1|
72619428|NCT01370642|144769644|SUPERIORITY_OR_OTHER||LS Mean Difference at Week 24|-0.9|||||TWO_SIDED|95.0|-1.2|-0.6|||Constrained LDA Model|||Change from BL in HCV RNA at Week 24 was computed using a constrained longitudinal data analysis model including treatment, time and the interaction of time by treatment with a restriction of the same baseline mean across treatment groups as well as adjusting for IL28B and age, and their interaction terms with time will be included in the model.||-0.6|-1.2|
72619429|NCT01927861|144769658|OTHER||Treatment difference|0.63|||<|0.0001|TWO_SIDED|95.0|0.38|0.88|||ANCOVA|||The change from baseline (week 0) in the height SDS after 104 weeks of treatment was analysed using an ANCOVA model with treatment as a fixed effect and baseline height SDS as a covariate.||0.88|0.38|< 0.0001
72619430|NCT00987935|144769726|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.357|||||TWO_SIDED|95.0|0.802|2.296|||||"Hazard ratio from Cox proportional hazards model stratified by macroscopic vacular invasion, extrahepatic spread, or both present vs both absent.~HR below 1 favors Nintedanib."|||2.296|0.802|
72447947|NCT03858634|144412955|SUPERIORITY||LS Mean Difference|53.2|STANDARD_ERROR_OF_MEAN|219.98||0.8315|TWO_SIDED|80.0|-361.63|467.98||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 12||467.98|-361.63|0.8315
72447948|NCT03858634|144412955|SUPERIORITY||LS Mean Difference|-67.6|STANDARD_ERROR_OF_MEAN|21.26||0.0055|TWO_SIDED|80.0|-95.92|-39.22||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 12||-39.22|-95.92|0.0055
72447949|NCT03858634|144412955|SUPERIORITY||LS Mean Difference|-57.9|STANDARD_ERROR_OF_MEAN|26.73||0.1188|TWO_SIDED|80.0|-101.7|-14.15||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 16||-14.15|-101.70|0.1188
72498396|NCT01264939|144527130|SUPERIORITY_OR_OTHER|||||||0.0006||95.0||||Multiplicity plan applied to the efficacy endpoints provided strong control of the type I error rate at 0.05 level by pre-specifying the hierarchical order of the efficacy endpoint tests.|Stratified Wilcoxon|Stratification variables included in the analysis were presence of angioedema at baseline (yes vs no) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis was that there was no difference between the placebo and the omalizumab 300 mg groups.||||0.0006
72447950|NCT03858634|144412955|SUPERIORITY||LS Mean Difference|3.0|STANDARD_ERROR_OF_MEAN|18.27||0.8697|TWO_SIDED|80.0|-21.26|27.35||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 16||27.35|-21.26|0.8697
72447951|NCT03858634|144412955|SUPERIORITY||LS Mean Difference|-30.3|STANDARD_ERROR_OF_MEAN|78.64||0.7368|TWO_SIDED|80.0|-178.62|117.94||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 16||117.94|-178.62|0.7368
72447952|NCT03858634|144412955|SUPERIORITY||LS Mean Difference|-9.0|STANDARD_ERROR_OF_MEAN|15.02||0.5571|TWO_SIDED|80.0|-29.03|11.03||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 16||11.03|-29.03|0.5571
72498397|NCT01264939|144527131|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Multiplicity plan applied to the efficacy endpoints provided strong control of the type I error rate at 0.05 level by pre-specifying the hierarchical order of the efficacy endpoint tests.|Cochran-Mantel-Haenszel|Covariates included in the analysis were baseline UAS7 (\< median vs ≥ median) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis was that there was no difference between the placebo and the omalizumab 300 mg groups.||||<0.0001
72619431|NCT00987935|144769727|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.213|||||TWO_SIDED|95.0|0.73|2.014|||||"Hazard ratio from Cox proportional hazards model stratified by macroscopic vacular invasion, extrahepatic spread, or both present vs both absent.~HR below 1 favors Nintedanib."|||2.014|0.730|
72619432|NCT00987935|144769731|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.186|||||TWO_SIDED|95.0|0.728|1.932|||||"Hazard ratio from Cox proportional hazards model stratified by macroscopic vacular invasion, extrahepatic spread, or both present vs both absent.~HR below 1 favors Nintedanib."|||1.932|0.728|
72619433|NCT00987935|144769732|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.94|||||TWO_SIDED|95.0|0.593|1.489|||||"Hazard ratio from Cox proportional hazards model stratified by macroscopic vacular invasion, extrahepatic spread, or both present vs both absent.~HR below 1 favors Nintedanib."|||1.489|0.593|
72619434|NCT02222181|144769742|SUPERIORITY_OR_OTHER|||||||0.23|||||||t-test, 1 sided|||||||0.23
72619435|NCT02222181|144769743|SUPERIORITY_OR_OTHER|||||||0.05|||||||t-test, 1 sided|||||||0.05
72619436|NCT02222181|144769744|SUPERIORITY_OR_OTHER|||||||0.03|||||||t-test, 1 sided|||||||0.03
72619437|NCT02222181|144769745|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 1 sided|||||||<0.001
72619438|NCT02222181|144769746|SUPERIORITY_OR_OTHER|||||||0.025|||||||t-test, 1 sided|||||||0.025
72619439|NCT02222181|144769747|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 1 sided|||||||<0.001
72619440|NCT02222181|144769748|SUPERIORITY_OR_OTHER|||||||0.05|||||||t-test, 1 sided|||||||0.05
72619441|NCT01245049|144769818|NON_INFERIORITY|To assess the Non-inferiority of the Boostrix Polio Group compared to the Repevax Group in terms of booster response to diphtheria, standardized asymptotic 95% CI for the groups'difference \[Repevax Group minus Boostrix Polio Group\] was computed. Non-inferiority criterion: Upper limit of the 95% CI of the groups' difference in booster response rate ≤10%.|Percentage difference|0.56|||||TWO_SIDED|95.0|-3.55|3.14|||Standardized asymptotic|||Non-inferiority in terms of booster response to D||3.14|-3.55|
72498398|NCT00125034|144527156|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.516||||0.064|TWO_SIDED|95.0|0.975|2.335|||stratified Cochran-Mantel-Haenszel test|Stratified odds ratio and Cochran-Mantel-Haenszel (CMH) statistics were calculated considering the randomization strata.||Assuming a difference in rate of best confirmed response of at least 20% between the 2 treatments, ie an approximately 70% response rate under cetuximab plus FOLFOX-4 \& 50% under FOLFOX-4 alone for the stratum with ECOG PS0-1 \& 66% and 45% respectively for the ECOG PS2 stratum, the common OddsR over the strata was expected to be 2.33. A sample size of approximately 146/group was calculated as necessary to detect a significant overall response of at least 2.33 at level α=0.05 with a power of 90%||2.335|0.975|0.064
72498399|NCT00125034|144527157|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.551||||0.0027|TWO_SIDED|95.0|1.38|4.717|||stratified Cochran-Mantel-Haenszel test|Stratified odds ratio and Cochran-Mantel-Haenszel (CMH) statistics were calculated considering the randomization strata.||||4.717|1.380|0.0027
72498400|NCT00125034|144527158|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.459||||0.029|TWO_SIDED|95.0|0.228|0.924|||stratified Cochran-Mantel-Haenszel test|Stratified odds ratio and Cochran-Mantel-Haenszel (CMH) statistics were calculated considering the randomization strata.||||0.924|0.228|0.0290
72498401|NCT00125034|144527159|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.931||||0.617|TWO_SIDED|95.0|0.705|1.23|||Stratified Log Rank|Kaplan-Meier method used to estimate median OS time. HR was calculated using Cox proportional hazards model stratified by randomization strata.||||1.230|0.705|0.6170
72498402|NCT00125034|144527160|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.567||||0.0064|TWO_SIDED|95.0|0.375|0.856|||Stratified Log Rank|Kaplan-Meier method used to estimate median OS time. HR was calculated using Cox proportional hazards model stratified by randomization strata.||||0.856|0.375|0.0064
72498403|NCT00125034|144527161|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.72||||0.0153|TWO_SIDED|95.0|1.104|2.679|||Stratified Log Rank|Kaplan-Meier method used to estimate median OS time. HR was calculated using Cox proportional hazards model stratified by randomization strata.||||2.679|1.104|0.0153
72498404|NCT00125034|144527162|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.015||||0.905|TWO_SIDED|95.0|0.791|1.303|||Stratified log rank|Kaplan-Meier method used to estimate median OS time. HR was calculated using Cox proportional hazards model stratified by randomization strata.||||1.303|0.791|0.9050
72498405|NCT00125034|144527163|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.855||||0.3854|TWO_SIDED|95.0|0.599|1.219|||Stratified log rank|Kaplan-Meier method used to estimate median OS time. HR was calculated using Cox proportional hazards model stratified by randomization strata.||||1.219|0.599|0.3854
72498406|NCT00125034|144527164|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.29||||0.2004|TWO_SIDED|95.0|0.873|1.906|||Stratified log rank|Kaplan-Meier method used to estimate median OS time. HR was calculated using Cox proportional hazards model stratified by randomization strata.||||1.906|0.873|0.2004
72498407|NCT00584870|144527175|SUPERIORITY_OR_OTHER_LEGACY||Least squares (LS) Mean Difference|-1.17|STANDARD_ERROR_OF_MEAN|0.39||0.001|TWO_SIDED|80.0|-1.67|-0.67||p-value was based on repeated measures model from pairwise comparisons, and statistical test was 1-sided with 0.1 significance level.|Repeated Measures Model|||LS mean difference was estimated from the repeated measures model with baseline, center, treatment, week and treatment-by-week interaction as fixed main effects and participant as random effect.||-0.67|-1.67|0.001
72498408|NCT02764541|144527285|EQUIVALENCE|The hypothesis is that there is no difference in anti-proliferative activity of Letrozole vs Tamoxifen by measuring the fold-change in percent Ki67 from baseline to day15 in log scale within hormone receptor positive breast cancer patients with invasive ductal carcinoma||||||0.0045|||||||Wilcoxon (Mann-Whitney)|||||||0.0045
72561511|NCT02102932|144653702|SUPERIORITY_OR_OTHER||Ratio of the geometric means|103.23|STANDARD_DEVIATION|6.6||0|TWO_SIDED|90.0|99.91|106.65||P-value for ratio outside interval 80-125|ANOVA||Ratio of the geometric means for treatments (Test (T2) versus Reference (R2)) i.e. T2/R2. The standard deviation is actually the intra-individual gCV.|"The statistical model used was an analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation:~'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed."||106.65|99.91|0.0000
72498409|NCT02764541|144527285|EQUIVALENCE|The hypothesis is that there is no difference in anti-proliferative activity of Letrozole vs Tamoxifen by measuring the fold-change in percent Ki67 from baseline to day15 in log scale within hormone receptor positive breast cancer patients with invasive lobular carcinoma||||||0.0161|||||||Wilcoxon (Mann-Whitney)|||||||0.0161
72498410|NCT02764541|144527286|EQUIVALENCE|The hypothesis is that there is no difference of pathologic response measured by RCB index between Arm C and Arm D||||||0.9288|||||||Wilcoxon (Mann-Whitney)|||||||0.9288
72498411|NCT02764541|144527288|EQUIVALENCE|The hypothesis is that there is no difference of pathologic response measured by RCB index between Arm C and Arm D|Mean Difference (Final Values)|0.02||||0.92|TWO_SIDED|95.0|-0.29|0.32|||Regression, Linear|||||0.32|-0.29|0.920
72498412|NCT02764541|144527289|EQUIVALENCE|The hypothesis is that there is no difference of RCB response rate between Arm C and Arm D||||||0.758|||||||Fisher Exact|||||||0.758
72498413|NCT00749190|144527291|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.24|STANDARD_ERROR_OF_MEAN|0.1||0.0226|TWO_SIDED|95.0|-0.44|-0.03||P-values are regarded as descriptive, adjustment for multiple testing was not necessary.|ANCOVA|Based on ANCOVA with terms for treatment, number of previously used anti-diabetic medications, country and baseline.|Difference calculated as empagliflozin 1 mg minus placebo|||-0.03|-0.44|0.0226
72498414|NCT00749190|144527291|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.39|STANDARD_ERROR_OF_MEAN|0.1||0.0002|TWO_SIDED|95.0|-0.59|-0.18||P-values are regarded as descriptive, adjustment for multiple testing was not necessary.|ANCOVA|Based on ANCOVA with terms for treatment, number of previously used anti-diabetic medications, country and baseline.|Difference calculated as empagliflozin 5 mg minus placebo|||-0.18|-0.59|0.0002
72498415|NCT00749190|144527291|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.71|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001|TWO_SIDED|95.0|-0.91|-0.51||P-values are regarded as descriptive, adjustment for multiple testing was not necessary.|ANCOVA|Based on ANCOVA with terms for treatment, number of previously used anti-diabetic medications, country and baseline.|Difference calculated as empagliflozin 10 mg minus placebo|||-0.51|-0.91|<0.0001
72619442|NCT01245049|144769818|NON_INFERIORITY|To assess the Non-inferiority of the Boostrix Polio Group compared to the Repevax Group in terms of booster response to tetanus, standardized asymptotic 95% CI for the groups' difference \[Repevax Group minus Boostrix Polio Group\] was computed. Non-inferiority criterion: Upper limit of the 95% CI of the groups' difference in booster response rate ≤10%.|Percentage difference|1.7|||||TWO_SIDED|95.0|-2.43|4.9||||||Non-inferiority in terms of booster response to T||4.9|-2.43|
72561512|NCT02102932|144653702|SUPERIORITY_OR_OTHER||Ratio of the geometric means|103.56|STANDARD_DEVIATION|7.6||0|TWO_SIDED|90.0|99.73|107.54||P-value for ratio outside interval 80-125|ANOVA||Ratio of the geometric means for treatments (Test (T3) versus Reference (R3)) i.e. T3/R3. The standard deviation is actually the intra-individual gCV.|"The statistical model used was an analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation:~'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed."||107.54|99.73|0.0000
72561513|NCT02102932|144653702|SUPERIORITY_OR_OTHER||Ratio of the geometric means|102.81|STANDARD_DEVIATION|6.9||0|TWO_SIDED|90.0|99.36|106.37||P-value for ratio outside interval 80-125|ANOVA||Ratio of the geometric means for treatments (Test (T4) versus Reference (R4)) i.e. T4/R4. The standard deviation is actually the intra-individual gCV.|"The statistical model used was an analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation:~'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed."||106.37|99.36|0.0000
72619443|NCT01245049|144769820|NON_INFERIORITY|Criterion for evaluation of the corresponding objective: Upper limit (UL) of the 95% confidence interval (CI) on the GMT ratio for the groups' (Repevax Group divided by Boostrix-Polio Group) was lower than or equal to (≤) 2.|Difference in adjusted GMT ratio|0.91|||||TWO_SIDED|95.0|0.65|1.28|||ANCOVA|||Immune response difference to anti-Polio 1 antigen||1.28|0.65|
72619444|NCT01245049|144769820|NON_INFERIORITY|Criterion for evaluation of the corresponding objective: UL of the 95% CI on the GMT ratio for the groups' (Repevax Group divided by Boostrix-Polio Group) ≤ 2.|Difference in adjusted GMT ratio|0.78|||||TWO_SIDED|95.0|0.54|1.12|||ANCOVA|||Immune response difference to anti-Polio 2 antigen||1.12|0.54|
72619445|NCT01245049|144769820|NON_INFERIORITY|Criterion for evaluation of the corresponding objective: UL of the 95% CI on the GMT ratio for the groups' (Repevax Group divided by Boostrix-Polio Group) ≤ 2.|Difference in adjusted GMT ratio|1.3|||||TWO_SIDED|95.0|0.93|1.84|||ANCOVA|||Immune response difference to anti-Polio 3 antigen||1.84|0.93|
72447953|NCT03858634|144412955|SUPERIORITY||LS Mean Difference|-49.1|STANDARD_ERROR_OF_MEAN|32.21||0.2251|TWO_SIDED|80.0|-101.8|3.69||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 18||3.69|-101.80|0.2251
72447954|NCT03858634|144412955|SUPERIORITY||LS Mean Difference|17.3|STANDARD_ERROR_OF_MEAN|18.93||0.3733|TWO_SIDED|80.0|-7.9|42.48||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 18||42.48|-7.90|0.3733
72447955|NCT03858634|144412955|SUPERIORITY||LS Mean Difference|-22.6|STANDARD_ERROR_OF_MEAN|66.57||0.7662|TWO_SIDED|80.0|-148.16|102.89||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 18||102.89|-148.16|0.7662
72447956|NCT03858634|144412955|OTHER||LS Mean Difference|-6.1|STANDARD_ERROR_OF_MEAN|16.87||0.7241|TWO_SIDED|80.0|-28.54|16.44||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 18||16.44|-28.54|0.7241
72447957|NCT03858634|144412957|SUPERIORITY||LS Mean Difference|-21.1|STANDARD_ERROR_OF_MEAN|29.04||0.5195|TWO_SIDED|80.0|-68.69|26.43||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 4||26.43|-68.69|0.5195
72447958|NCT03858634|144412957|SUPERIORITY||LS Mean Difference|11.3|STANDARD_ERROR_OF_MEAN|8.27||0.1869|TWO_SIDED|80.0|0.34|22.26||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 4||22.26|0.34|0.1869
72447959|NCT03858634|144412957|SUPERIORITY||LS Mean Difference|-87.5|STANDARD_ERROR_OF_MEAN|55.3||0.2545|TWO_SIDED|80.0|-191.75|16.79||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 4||16.79|-191.75|0.2545
72447960|NCT03858634|144412957|SUPERIORITY||LS Mean Difference|-20.2|STANDARD_ERROR_OF_MEAN|10.26||0.0643|TWO_SIDED|80.0|-33.88|-6.57||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 4||-6.57|-33.88|0.0643
72447961|NCT03858634|144412957|SUPERIORITY||LS Mean Difference|-28.6|STANDARD_ERROR_OF_MEAN|20.11||0.2503|TWO_SIDED|80.0|-61.52|4.35||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 8||4.35|-61.52|0.2503
72447962|NCT03858634|144412957|SUPERIORITY||LS Mean Difference|2.3|STANDARD_ERROR_OF_MEAN|11.58||0.8468|TWO_SIDED|80.0|-13.08|17.62||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 8||17.62|-13.08|0.8468
72447963|NCT03858634|144412957|SUPERIORITY||LS Mean Difference|-83.6|STANDARD_ERROR_OF_MEAN|73.93||0.3755|TWO_SIDED|80.0|-222.98|55.18||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 8||55.18|-222.98|0.3755
72447964|NCT03858634|144412957|SUPERIORITY||LS Mean Difference|-20.9|STANDARD_ERROR_OF_MEAN|11.06||0.0755|TWO_SIDED|80.0|-35.58|-6.15||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 8||-6.15|-35.58|0.0755
72447965|NCT03858634|144412957|SUPERIORITY||LS Mean Difference|-28.6|STANDARD_ERROR_OF_MEAN|25.77||0.3486|TWO_SIDED|80.0|-70.76|13.65||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 12||13.65|-70.76|0.3486
72447966|NCT03858634|144412957|SUPERIORITY||LS Mean Difference|-4.4|STANDARD_ERROR_OF_MEAN|9.69||0.6559|TWO_SIDED|80.0|-17.28|8.5||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 12||8.50|-17.28|0.6559
72447967|NCT03858634|144412957|SUPERIORITY||LS Mean Difference|-70.2|STANDARD_ERROR_OF_MEAN|50.46||0.2987|TWO_SIDED|80.0|-165.35|24.94||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 12||24.94|-165.35|0.2987
72619446|NCT02151604|144769852|OTHER||Pearson's coefficient|-0.57||||0.041|TWO_SIDED||||||Pearson's correlation analysis|||Correlation with field of irradiation||||0.041
72370181|NCT03085797|144250810|OTHER||Difference in Medians|-3.18||||0.003|TWO_SIDED|95.0|-4.1|-2.26||p-Value was based on Wilcoxon rank-sum test and is adjusted for multiplicity.|Wilcoxon rank-sum test||Quantile regression with covariates: treatment, region, Baseline score, Baseline BEC. Par. with nasal surgery prior to Wks 49-52/withdrew early with no nasal surgery assigned their worst observed 4-wk mean prior to nasal surgery/study withdrawal.|||-2.26|-4.10|0.003
72498416|NCT00749190|144527291|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001|TWO_SIDED|95.0|-0.91|-0.5||P-values are regarded as descriptive, adjustment for multiple testing was not necessary.|ANCOVA|Based on ANCOVA with terms for treatment, number of previously used anti-diabetic medications, country and baseline.|Difference calculated as empagliflozin 25 mg minus placebo|||-0.50|-0.91|<0.0001
72498417|NCT00749190|144527291|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.64|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001|TWO_SIDED|95.0|-0.84|-0.43||P-values are regarded as descriptive, adjustment for multiple testing was not necessary.|ANCOVA|Based on ANCOVA with terms for treatment, number of previously used anti-diabetic medications, country and baseline.|Difference calculated as empagliflozin 50 mg minus placebo|||-0.43|-0.84|<0.0001
72561514|NCT02102932|144653703|SUPERIORITY_OR_OTHER||Ratio of the geometric means|104.56|STANDARD_DEVIATION|14.0||0.0001|TWO_SIDED|90.0|97.56|112.07||P-value for ratio outside interval 80-125|ANOVA||Ratio of the geometric means for treatments (Test (T1) versus Reference (R1)) i.e. T1/R1. The standard deviation is actually the intra-individual gCV.|"The statistical model used was an analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation:~'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed."||112.07|97.56|0.0001
72561515|NCT02102932|144653703|SUPERIORITY_OR_OTHER||Ratio of the geometric means|105.8|STANDARD_DEVIATION|12.8||0.0001|TWO_SIDED|90.0|99.32|112.7||P-value for ratio outside interval 80-125|ANOVA||Ratio of the geometric means for treatments (Test (T2) versus Reference (R2)) i.e. T2/R2. The standard deviation is actually the intra-individual gCV.|"The statistical model used was an analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation:~'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed."||112.70|99.32|0.0001
72561516|NCT02102932|144653703|SUPERIORITY_OR_OTHER||Ratio of the geometric means|103.75|STANDARD_DEVIATION|11.2||0|TWO_SIDED|90.0|98.18|109.63||P-value for ratio outside interval 80-125|ANOVA||Ratio of the geometric means for treatments (Test (T3) versus Reference (R3)) i.e. T3/R3. The standard deviation is actually the intra-individual gCV.|"The statistical model used was an analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation:~'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed."||109.63|98.18|0.0000
72561517|NCT02102932|144653703|SUPERIORITY_OR_OTHER||Ratio of the geometric means|95.77|STANDARD_DEVIATION|12.8||0|TWO_SIDED|90.0|89.88|102.03||P-value for ratio outside interval 80-125|ANOVA||Ratio of the geometric means for treatments (Test (T4) versus Reference (R4)) i.e. T4/R4. The standard deviation is actually the intra-individual gCV.|"The statistical model used was an analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation:~'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed."||102.03|89.88|0.0000
72561518|NCT02102932|144653704|SUPERIORITY_OR_OTHER||Ratio of the geometric means|106.44|STANDARD_DEVIATION|11.8||0|TWO_SIDED|90.0|100.44|112.8||P-value for ratio outside interval 80-125|ANOVA||Ratio of the geometric means for treatments (Test (T1) versus Reference (R1)) i.e. T1/R1. The standard deviation is actually the intra-individual gCV.|"The statistical model used was an analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation:~'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed."||112.80|100.44|0.0000
72561519|NCT02102932|144653704|SUPERIORITY_OR_OTHER||Ratio of the geometric means|110.78|STANDARD_DEVIATION|13.2||0.0021|TWO_SIDED|90.0|103.8|118.24||P-value for ratio outside interval 80-125|ANOVA||Ratio of the geometric means for treatments (Test (T2) versus Reference (R2)) i.e. T2/R2. The standard deviation is actually the intra-individual gCV.|"The statistical model used was an analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation:~'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed."||118.24|103.80|0.0021
72561520|NCT02102932|144653704|SUPERIORITY_OR_OTHER||Ratio of the geometric means|101.38|STANDARD_DEVIATION|13.6||0|TWO_SIDED|90.0|94.82|108.39||P-value for ratio outside interval 80-125|ANOVA||Ratio of the geometric means for treatments (Test (T3) versus Reference (R3)) i.e. T3/R3. The standard deviation is actually the intra-individual gCV.|"The statistical model used was an analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation:~'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed."||108.39|94.82|0.0000
72619447|NCT02151604|144769854|OTHER||Pearson's coefficient|0.6||||0.037|TWO_SIDED|||||Pearson's correlation coefficient: 0.60|Pearson's Correlation Analysis|0.60||Correlation of change in ventilation signal with that of alveolar volume (VA)||||0.037
72619448|NCT02151604|144769854|OTHER||Pearson's correlation coefficient|0.7||||0.012|TWO_SIDED||||||Pearson's correlation analysis|Pearson's correlation coefficient: 0.70||Correlation of change in ventilation signal with that of diffusing capacity for carbon monoxide(TLCO)||||0.012
72619449|NCT02151604|144769854|OTHER||Pearson's correlation coefficient|-0.85||||0.032|TWO_SIDED||||||Pearson's correlation analysis|R = -0.85||Correlation of change in ventilation signal with that of residual volume (RV)||||0.032
72619450|NCT02151604|144769854|OTHER||Pearson's correlation coefficient|-0.95||||0.004|TWO_SIDED||||||Pearson's correlation analysis|R = -0.95||Correlation of change in ventilation signal with that of functional residual capacity (FRC)||||0.004
72447968|NCT03858634|144412957|SUPERIORITY||LS Mean Difference|-16.7|STANDARD_ERROR_OF_MEAN|12.43||0.1966|TWO_SIDED|80.0|-33.29|-0.13||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 12||-0.13|-33.29|0.1966
72447969|NCT03858634|144412957|SUPERIORITY||LS Mean Difference|-41.5|STANDARD_ERROR_OF_MEAN|25.7||0.2051|TWO_SIDED|80.0|-83.56|0.62||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 16||0.62|-83.56|0.2051
72447970|NCT03858634|144412957|SUPERIORITY||LS Mean Difference|-3.3|STANDARD_ERROR_OF_MEAN|10.16||0.7511|TWO_SIDED|80.0|-16.79|10.25||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 16||10.25|-16.79|0.7511
72447971|NCT03858634|144412957|SUPERIORITY||LS Mean Difference|-79.6|STANDARD_DEVIATION|39.27||0.1797|TWO_SIDED|80.0|-153.68|-5.59||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 16||-5.59|-153.68|0.1797
72447972|NCT03858634|144412957|SUPERIORITY||LS Mean Difference|-16.3|STANDARD_ERROR_OF_MEAN|11.45||0.1715|TWO_SIDED|80.0|-31.61|-1.08||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 16||-1.08|-31.61|0.1715
72447973|NCT03858634|144412957|SUPERIORITY||LS Mean Difference|-36.5|STANDARD_ERROR_OF_MEAN|21.32||0.185|TWO_SIDED|80.0|-71.47|-1.63||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 18||-1.63|-71.47|0.1850
72498418|NCT01565980|144527354|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|||||P-values for the comparison of least square (LS) means represent the effect of the trial arm. The effect sizes are calculated as Cohen's d: difference between LS means divided by the standard deviation.|Mixed Models Analysis|||The outcome measure was analyzed using linear mixed effects models (LME). The main effect of the trial arm was evaluated by averaging time 2 and time 3 values of the outcomes within the LME model. The resulting least square (LS) means and their standard errors are reported.||||<.05
72498419|NCT01565980|144527355|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|||||P values below 0.05 are considered statistically significant in this study.|Mixed Models Analysis|||||||<0.05
72498420|NCT01565980|144527356|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|||||P values below 0.05 are considered statistically significant in this study.|Mixed Models Analysis|||||||<.05
72561521|NCT02102932|144653704|SUPERIORITY_OR_OTHER||Ratio of the geometric means|103.02|STANDARD_DEVIATION|16.3||0.0002|TWO_SIDED|90.0|95.08|111.63||P-value for ratio outside interval 80-125|ANOVA||Ratio of the geometric means for treatments (Test (T4) versus Reference (R4)) i.e. T4/R4. The standard deviation is actually the intra-individual gCV.|"The statistical model used was an analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation:~'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed."||111.63|95.08|0.0002
72447974|NCT03858634|144412957|SUPERIORITY||LS Mean Difference|-4.9|STANDARD_ERROR_OF_MEAN|12.19||0.6907|TWO_SIDED|80.0|-21.15|11.29||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 18||11.29|-21.15|0.6907
72447975|NCT03858634|144412957|SUPERIORITY||LS Mean Difference|-74.0|STANDARD_ERROR_OF_MEAN|23.85||0.0901|TWO_SIDED|80.0|-118.97|-29.02||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 18||-29.02|-118.97|0.0901
72447976|NCT03858634|144412957|SUPERIORITY||LS Mean Difference|-7.8|STANDARD_ERROR_OF_MEAN|13.34||0.564|TWO_SIDED|80.0|-25.64|9.94||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 18||9.94|-25.64|0.5640
72561522|NCT02102932|144653705|SUPERIORITY_OR_OTHER||Ratio of the geometric means|104.91|STANDARD_DEVIATION|11.2||0|TWO_SIDED|90.0|99.29|110.86||P-value for ratio outside interval 80-125|ANOVA||Ratio of the geometric means for treatments (Test (T1) versus Reference (R1)) i.e. T1/R1. The standard deviation is actually the intra-individual gCV.|"The statistical model used was an analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation:~'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed."||110.86|99.29|0.0000
72619451|NCT02151604|144769854|OTHER||Pearson's correlation coefficient|-0.88||||0.012|TWO_SIDED||||||Pearson's correlation analysis|Pearson's correlation coefficient = -0.88||Correlation of change in ventilation signal with that of inspiratory capacity(IC)||||0.012
72447977|NCT03858634|144412958|SUPERIORITY||LS mean difference|-31.7|STANDARD_ERROR_OF_MEAN|38.73||0.4734|TWO_SIDED|80.0|-95.11|31.76||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||||31.76|-95.11|0.4734
72447978|NCT03858634|144412958|SUPERIORITY||LS mean difference|-3.6|STANDARD_ERROR_OF_MEAN|14.91||0.813|TWO_SIDED|80.0|-23.33|16.18||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||||16.18|-23.33|0.8130
72447979|NCT03858634|144412958|SUPERIORITY||LS mean difference|-92.0|STANDARD_ERROR_OF_MEAN|31.1||0.0979|TWO_SIDED|80.0|-150.6|-33.32||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||||-33.32|-150.60|0.0979
72447980|NCT03858634|144412958|SUPERIORITY||LS mean difference|-37.5|STANDARD_ERROR_OF_MEAN|13.48||0.0122|TWO_SIDED|80.0|-55.48|-19.61||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||||-19.61|-55.48|0.0122
72447981|NCT03150173|144413005|SUPERIORITY|||||||0.94|||||||Chi-squared|||||||0.94
72447982|NCT03904147|144413117|SUPERIORITY||Win Ratio|1.44||||0.0311|TWO_SIDED||||||Finkelstein-Schoenfeld Method||The Win Ratio provides an estimation of the treatment effect.|||||0.0311
72447983|NCT03904147|144413118|SUPERIORITY|||||||0.0008|||||||exact test|||||||0.0008
72447984|NCT03904147|144413119|SUPERIORITY||||||<|0.0001|||||||Z test|||||||<0.0001
72447985|NCT03904147|144413120|SUPERIORITY||||||<|0.0001|||||||ANCOVA model|||||||<0.0001
72447986|NCT03904147|144413121|SUPERIORITY||||||<|0.0001|||||||Chi-square test|||||||<0.0001
72447987|NCT03904147|144413122|SUPERIORITY|||||||0.2482|||||||ANCOVA model|||||||0.2482
72498421|NCT01565980|144527357|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|||||P values below 0.05 are considered statistically significant in this study.|Mixed Models Analysis|||||||<0.05
72447988|NCT03904147|144413123|SUPERIORITY||||||<|0.0001|||||||Exact test|||||||<0.0001
72447989|NCT03904147|144413124|SUPERIORITY||||||<|0.0001|||||||Binomial exact method|||||||<0.0001
72447990|NCT03904147|144413125|SUPERIORITY|||||||0.109|||||||normal approximation|||||||0.1090
72447991|NCT01037881|144413128|SUPERIORITY||Difference in least squares mean|-1.29||||0.27|TWO_SIDED|95.0|-3.6|1.03|||ANOVA|||Active treatment minus vehicle, adjusted for the effect of (pooled) country.||1.03|-3.60|0.27
72447992|NCT01037881|144413128|SUPERIORITY||Difference in least squares mean|-0.25||||0.83|TWO_SIDED|95.0|-2.53|2.04|||ANOVA|||Active treatment minus vehicle, adjusted for the effect of (pooled) country.||2.04|-2.53|0.83
72498422|NCT01565980|144527358|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|||||P values below 0.05 are considered statistically significant in this study.|Mixed Models Analysis|||||||<0.05
72498423|NCT01565980|144527359|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|||||P values below 0.05 are considered statistically significant in this study.|Mixed Models Analysis|||||||<0.05
72498424|NCT01565980|144527360|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|||||P values above 0.05 are considered statistically insignificant in this study.|Descriptive statistics for outcomes|||||||<0.05
72498425|NCT03219164|144527368|NON_INFERIORITY|Non-inferiority of the 14-day treatment regimen was claimed if the lower bound of 1-sided 97.5% confidence limit of the treatment difference (14-day course group vs 28-day course group) was above the noninferiority margin of -20%.|Difference in percentage|-8.0|||||TWO_SIDED|95.0|-24.6|8.6|||||The difference in percentage between treatment groups, and the associated 95% CIs were constructed based on stratum-adjusted Mantel-Haenszel method using age as stratification factor.|||8.6|-24.6|
72561523|NCT02102932|144653705|SUPERIORITY_OR_OTHER||Ratio of the geometric means|106.32|STANDARD_DEVIATION|15.7||0.0008|TWO_SIDED|90.0|98.39|114.88||P-value for ratio outside interval 80-125|ANOVA||Ratio of the geometric means for treatments (Test (T2) versus Reference (R2)) i.e. T2/R2. The standard deviation is actually the intra-individual gCV.|"The statistical model used was an analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation:~'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed."||114.88|98.39|0.0008
72561524|NCT02102932|144653705|SUPERIORITY_OR_OTHER||Ratio of the geometric means|104.44|STANDARD_DEVIATION|15.7||0.0003|TWO_SIDED|90.0|96.68|112.82||P-value for ratio outside interval 80-125|ANOVA||Ratio of the geometric means for treatments (Test (T3) versus Reference (R3)) i.e. T3/R3. The standard deviation is actually the intra-individual gCV.|"The statistical model used was an analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation:~'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed."||112.82|96.68|0.0003
72498426|NCT03219164|144527370|OTHER||||||||||||||||||The historical pooled data from published results for the percentage of participants with successful PA eradication at 28 days post-treatment with TNS was estimated to be 77%.|||
72561525|NCT02102932|144653705|SUPERIORITY_OR_OTHER||Ratio of the geometric means|96.61|STANDARD_DEVIATION|16.9||0.0004|TWO_SIDED|90.0|88.9|104.99||P-value for ratio outside interval 80-125|ANOVA||Ratio of the geometric means for treatments (Test (T4) versus Reference (R4)) i.e. T4/R4. The standard deviation is actually the intra-individual gCV.|"The statistical model used was an analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation:~'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed."||104.99|88.90|0.0004
72561526|NCT02102932|144653706|SUPERIORITY_OR_OTHER||Ratio of the geometric means|105.16|STANDARD_DEVIATION|6.2||0|TWO_SIDED|90.0|101.97|108.45||P-value for ratio outside interval 80-125|ANOVA||Ratio of the geometric means for treatments (Test (T1) versus Reference (R1)) i.e. T1/R1. The standard deviation is actually the intra-individual gCV.|"The statistical model used was an analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation:~'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed."||108.45|101.97|0.0000
72447993|NCT01037881|144413128|SUPERIORITY||Difference in least squares mean|-2.01||||0.08|TWO_SIDED|95.0|-4.3|0.28|||ANOVA|||Active treatment minus vehicle, adjusted for the effect of (pooled) country.||0.28|-4.30|0.08
72447994|NCT01037881|144413128|SUPERIORITY||Difference in least squares mean|-1.56||||0.16|TWO_SIDED|95.0|-3.77|0.65|||ANOVA|||Active treatment minus vehicle, adjusted for the effect of (pooled) country.||0.65|-3.77|0.16
72447995|NCT01037881|144413128|SUPERIORITY||Difference in least squares mean|-1.65||||0.14|TWO_SIDED|95.0|-3.84|0.54|||ANOVA|||Active treatment minus vehicle, adjusted for the effect of (pooled) country.||0.54|-3.84|0.14
72447996|NCT01037881|144413128|SUPERIORITY||Difference in least squares mean|-2.46||||0.04|TWO_SIDED|95.0|-4.47|-0.17|||ANOVA|||Active treatment minus vehicle, adjusted for the effect of (pooled) country.||-0.17|-4.47|0.04
72447997|NCT01037881|144413128|SUPERIORITY||Difference in least squares mean|2.46||||0.04|TWO_SIDED|95.0|0.17|4.74|||ANOVA|||LEO 29102 treatment minus Elidel, adjusted for the effect of (pooled) country.||4.74|0.17|0.04
72447998|NCT01037881|144413128|SUPERIORITY||Difference in least squares mean|1.17||||0.32|TWO_SIDED|95.0|-1.14|3.48|||ANOVA|||LEO 29102 treatment minus Elidel, adjusted for the effect of (pooled) country.||3.48|-1.14|0.32
72447999|NCT01037881|144413128|SUPERIORITY||Difference in least squares mean|2.21||||0.06|TWO_SIDED|95.0|-0.08|4.5|||ANOVA|||LEO 29102 treatment minus Elidel, adjusted for the effect of (pooled) country.||4.50|-0.08|0.06
72498427|NCT02689492|144527374|OTHER||Intercept|68.5027|STANDARD_DEVIATION|8.0355|||||||||||Standard deviation is actually standard error.|||||
72498428|NCT02689492|144527375|OTHER||Intercept|95.4051|STANDARD_DEVIATION|6.9951|||||||||||Standard deviation is actually standard error.|||||
72498429|NCT02689492|144527376|OTHER||Intercept|74.8895|STANDARD_DEVIATION|8.0048|||||||||||Standard deviation is actually standard error.|||||
72448000|NCT01037881|144413128|SUPERIORITY||Difference in least squares mean|0.45||||0.7|TWO_SIDED|95.0|-1.84|2.73|||ANOVA|||LEO 29102 treatment minus Elidel, adjusted for the effect of (pooled) country.||2.73|-1.84|0.70
72448001|NCT01037881|144413128|SUPERIORITY||Difference in least squares mean|0.9||||0.42|TWO_SIDED|95.0|-1.31|3.1|||ANOVA|||LEO 29102 treatment minus Elidel, adjusted for the effect of (pooled) country.||3.10|-1.31|0.42
72448002|NCT01037881|144413128|SUPERIORITY||Difference in least squares mean|0.81||||0.47|TWO_SIDED|95.0|-1.38|3.0|||ANOVA|||LEO 29102 treatment minus Elidel, adjusted for the effect of (pooled) country.||3.00|-1.38|0.47
72448003|NCT00764751|144413134|SUPERIORITY||Mean Difference (Final Values)|15.4|||=|0.003|TWO_SIDED|95.0|5.6|25.0|||Paired t-test|||||25|5.6|=0.003
72561527|NCT02102932|144653706|SUPERIORITY_OR_OTHER||Ratio of the geometric means|103.07|STANDARD_DEVIATION|6.6||0|TWO_SIDED|90.0|99.75|106.5||P-value for ratio outside interval 80-125|ANOVA||Ratio of the geometric means for treatments (Test (T2) versus Reference (R2)) i.e. T2/R2. The standard deviation is actually the intra-individual gCV.|"The statistical model used was an analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation:~'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed."||106.50|99.75|0.0000
72561528|NCT02102932|144653706|SUPERIORITY_OR_OTHER||Ratio of the geometric means|103.14|STANDARD_DEVIATION|7.5||0|TWO_SIDED|90.0|99.37|107.04||P-value for ratio outside interval 80-125|ANOVA||Ratio of the geometric means for treatments (Test (T3) versus Reference (R3)) i.e. T3/R3. The standard deviation is actually the intra-individual gCV.|"The statistical model used was an analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation:~'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed."||107.04|99.37|0.0000
72561529|NCT02102932|144653706|SUPERIORITY_OR_OTHER||Ratio of the geometric means|102.61|STANDARD_DEVIATION|7.0||0|TWO_SIDED|90.0|99.1|106.25||P-value for ratio outside interval 80-125|ANOVA||Ratio of the geometric means for treatments (Test (T4) versus Reference (R4)) i.e. T4/R4. The standard deviation is actually the intra-individual gCV.|"The statistical model used was an analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation:~'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed."||106.25|99.10|0.0000
72561530|NCT02102932|144653707|SUPERIORITY_OR_OTHER||Ratio of the geometric means|105.33|STANDARD_DEVIATION|11.9||0|TWO_SIDED|90.0|99.34|111.68||P-value for ratio outside interval 80-125|ANOVA||Ratio of the geometric means for treatments (Test (T1) versus Reference (R1)) i.e. T1/R1. The standard deviation is actually the intra-individual gCV.|"The statistical model used was an analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation:~'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed."||111.68|99.34|0.0000
72370182|NCT03085797|144250811|OTHER||Difference in Medians|-16.49||||0.003|TWO_SIDED|95.0|-23.57|-9.42||p-Value was based on Wilcoxon rank-sum test and is adjusted for multiplicity.|Wilcoxon rank-sum test||Quantile regression with covariates: treatment, region, Baseline score, Baseline BEC. Par. with nasal surgery prior to Wk 52/withdrew early with no nasal surgery assigned their worst observed score prior to nasal surgery/study withdrawal.|||-9.42|-23.57|0.003
72448004|NCT00764751|144413134|SUPERIORITY||Mean Difference (Final Values)|-17.1||||0.07|TWO_SIDED|95.0|-36.0|1.9|||Paired t-test|||||1.9|-36.0|0.07
72448005|NCT04563546|144413143|OTHER||||||<|0.001||||||Unadjusted p-value. Threshold for statistical significance = 0.05|Chi-squared|||||||<0.001
72448006|NCT04563546|144413144|OTHER|||||||0.739|||||||Chi-squared|||||||0.739
72448007|NCT04563546|144413145|OTHER||||||<|0.001||||||Unadjusted p-value. Threshold for statistical significance = 0.05|Chi-squared|||||||<0.001
72448008|NCT04413708|144413204|SUPERIORITY||Risk Ratio (RR)|1.62||||0.41|TWO_SIDED|95.0|0.5|5.17|||Fisher Exact|||||5.17|0.50|0.41
72448009|NCT04413708|144413205|SUPERIORITY||Risk Ratio (RR)|1.07||||1|TWO_SIDED|95.0|0.61|1.9|||Fisher Exact|||||1.90|0.61|1.0
72448010|NCT03133546|144413218|SUPERIORITY||Hazard Ratio (HR)|0.96||||0.84|TWO_SIDED|95.0|0.68|1.37||significance level: 5%|Regression, Cox|Univariate Cox for PFS with treatment effect only|The HR for Osimertinib plus Bevacizumab versus Osimertinib alone is provided.|"Assumption: Median PFS with osimertinib 11 months Target: Detect a 36% improvement in PFS (HR=0.64, corresponding to an increase in median PFS to 17.2 months) under osimertinib and bevacizumab (80% power, at one-sided significant level of 5%)~126 events required"||1.37|0.68|0.84
72448011|NCT03468868|144413224|NON_INFERIORITY|We chose a non-inferiority margin of 10% (or 0.10 feet per second) for this population.|Mean Difference (Final Values)|0.15|STANDARD_DEVIATION|1.1|<|0.01|TWO_SIDED|95.0|-0.14|0.44|||t-test, 2 sided|||||0.44|-0.14|<0.01
72448012|NCT03468868|144413225|SUPERIORITY||Mean Difference (Final Values)|72.46|STANDARD_DEVIATION|384.1||0.16|TWO_SIDED|95.0|-29.56|174.5|||t-test, 2 sided|||||174.5|-29.56|0.16
72448013|NCT03468868|144413226|SUPERIORITY||Mean Difference (Final Values)|-4.71|STANDARD_DEVIATION|24.96||0.13|TWO_SIDED|95.0|-10.84|1.41|||t-test, 2 sided|||||1.41|-10.84|0.13
72448014|NCT03468868|144413227|SUPERIORITY||Mean Difference (Final Values)|0.88|STANDARD_DEVIATION|18.22||0.7|TWO_SIDED|95.0|-3.55|5.32|||t-test, 2 sided|||||5.32|-3.55|0.70
72448015|NCT03468868|144413228|SUPERIORITY||Mean Difference (Final Values)|0.66|STANDARD_DEVIATION|6.71||0.43|TWO_SIDED|95.0|-0.97|2.3|||t-test, 2 sided|||NeuroQOL Anxiety Domain||2.30|-0.97|0.43
72448016|NCT03468868|144413228|SUPERIORITY||Mean Difference (Final Values)|0.24|STANDARD_DEVIATION|6.16||0.75|TWO_SIDED|95.0|-1.26|1.74|||t-test, 2 sided|||NeuroQOL Depression Domain||1.74|-1.26|0.75
72448017|NCT03468868|144413228|SUPERIORITY||Mean Difference (Final Values)|-0.87|STANDARD_DEVIATION|7.54||0.35|TWO_SIDED|95.0|-2.71|0.97|||t-test, 2 sided|||NeuroQOL Fatigue Domain||0.97|-2.71|0.35
72448018|NCT03468868|144413228|SUPERIORITY||Mean Difference (Final Values)|0.06|STANDARD_DEVIATION|3.83||0.91|TWO_SIDED|95.0|-0.88|0.99|||t-test, 2 sided|||NeuroQOL Upper Extremity Function Domain||0.99|-0.88|0.91
72448019|NCT03468868|144413228|SUPERIORITY||Mean Difference (Final Values)|1.52|STANDARD_DEVIATION|5.44||0.02|TWO_SIDED|95.0|0.2|2.85|||t-test, 2 sided|||NeuroQOL Lower Extremity Function Domain||2.85|0.20|0.02
72448020|NCT03468868|144413228|SUPERIORITY||Mean Difference (Final Values)|-0.89||||0.29|TWO_SIDED|95.0|-2.54|0.76|||t-test, 2 sided|||NeuroQOL Cognitive Function Domain||0.76|-2.54|0.29
72448021|NCT03468868|144413228|SUPERIORITY||Mean Difference (Final Values)|1.08||||0.11|TWO_SIDED|95.0|-0.26|2.42|||t-test, 2 sided|||NeuroQOL Emotional and Behavioral Dyscontrol Domain||2.42|-0.26|0.11
72448022|NCT03468868|144413228|SUPERIORITY||Mean Difference (Final Values)|0.55|STANDARD_DEVIATION|7.13||0.54|TWO_SIDED|95.0|-1.19|2.28|||t-test, 2 sided|||NeuroQOL Positive Affect and Well-Being Domain||2.28|-1.19|0.54
72498430|NCT00951821|144527383|SUPERIORITY_OR_OTHER||Slope|-3.3||||0.46|TWO_SIDED|95.0|-12.1|5.5||Effect sizes were also calculated due to small sample size|Mixed Models Analysis||The reported statistic (-3.3) is the difference in the change from baseline to follow-up between the two treatment arms, estimated in a mixed effect regression model.|||5.5|-12.1|.46
72448023|NCT03468868|144413228|SUPERIORITY||Mean Difference (Final Values)|-0.59|STANDARD_DEVIATION|5.76||0.41|TWO_SIDED|95.0|-2.0|0.81|||t-test, 2 sided|||NeuroQOL Sleep Disturbance Domain||0.81|-2.00|0.41
72448024|NCT03468868|144413228|SUPERIORITY||Mean Difference (Final Values)|-0.4|STANDARD_DEVIATION|6.65||0.63|TWO_SIDED|95.0|-1.22|2.02|||t-test, 2 sided|||NeuroQOL Ability to Participate in Social Roles and Activities Domain||2.02|-1.22|0.63
72448025|NCT03468868|144413228|SUPERIORITY||Mean Difference (Final Values)|0.65|STANDARD_DEVIATION|7.44||0.48|TWO_SIDED|95.0|-1.16|2.47|||t-test, 2 sided|||NeuroQOL Satisfaction with Social Roles and Activities Domain||2.47|-1.16|0.48
72448026|NCT03468868|144413228|SUPERIORITY||Mean Difference (Final Values)|0.07|STANDARD_DEVIATION|5.68||0.92|TWO_SIDED|95.0|-1.32|1.45|||t-test, 2 sided|||NeuroQOL Stigma Domain||1.45|-1.32|0.92
72498431|NCT00951821|144527384|SUPERIORITY_OR_OTHER||Slope|0.4||||0.75|TWO_SIDED|95.0|-2.36|3.06|||Mixed Models Analysis||The statistic provided (0.4) is the difference in the change in BDI score from baseline to follow-up by treatment group.|||3.06|-2.36|.75
72498432|NCT03124459|144527394|SUPERIORITY||Mean Difference (Final Values)|13.5|STANDARD_ERROR_OF_MEAN|5.2||0.01|TWO_SIDED|90.0|4.9|22.1|||ANCOVA|||||22.1|4.9|0.01
72498433|NCT03124459|144527395|SUPERIORITY||Mean Difference (Final Values)|-3.1|STANDARD_ERROR_OF_MEAN|2.2||0.16|TWO_SIDED|90.0|-6.8|0.6|||ANCOVA|||||0.6|-6.8|0.16
72498434|NCT03124459|144527396|SUPERIORITY||Mean Difference (Final Values)|35.4|STANDARD_ERROR_OF_MEAN|23.5||0.13|TWO_SIDED|90.0|-3.2|74.0|||ANCOVA|||||74|-3.2|0.13
72498435|NCT03124459|144527397|SUPERIORITY||Mean Difference (Final Values)|1.9|STANDARD_ERROR_OF_MEAN|5.5||0.73|TWO_SIDED|90.0|-7.1|10.9|||ANCOVA|||||10.9|-7.1|0.73
72498436|NCT03124459|144527398|SUPERIORITY||Mean Difference (Final Values)|3.1|STANDARD_ERROR_OF_MEAN|4.7||0.51|TWO_SIDED|90.0|-4.6|10.9|||ANCOVA|||||10.9|-4.6|0.51
72498437|NCT03124459|144527403|SUPERIORITY||Mean Difference (Final Values)|-1.9|STANDARD_ERROR_OF_MEAN|3.9||0.63|TWO_SIDED|90.0|-8.4|4.6|||ANCOVA|||||4.6|-8.4|0.63
72498438|NCT03051633|144527437|SUPERIORITY|Event: Dichotimized self-reported first-time alcohol use in known participant history prior to data-collection, where substance use was not previously reported in prior measurement occasions of this four-wave longitudinal study. Episodes: Episodes represent the period of time between measurement occasions, as such, each episode represents the measured period of time between each wave of assessments. Censoring: If substance use was reported, censoring indicator indicates the risk period|Hazard Ratio (HR)|-0.42||||0.004|TWO_SIDED|95.0|-0.714|-0.126|||Regression, Logistic|Discrete time hazard model represents a survival analysis, with the outcome parameters reflecting a hazard ratio rather than odds.||Discrete time hazard represents the conditional probability that a student will experience first time alcohol use during a given measurement period, given that students did not use alchohol in a previous measurement period. Thus for each model, we tested the following hypothesis: Controlling for age at first-assessment, students attending BUYOI-assigned schools will have a lower risk of substance use uptake by the end of their eighth-grade year, relative to students attending control schools.||-0.126|-0.714|.004
72448027|NCT03468868|144413228|SUPERIORITY||Mean Difference (Final Values)|-0.47|STANDARD_DEVIATION|3.45||0.28|TWO_SIDED|95.0|-1.31|0.37|||t-test, 2 sided|||NeuroQOL Communication Domain||0.37|-1.31|0.28
72448028|NCT03468868|144413229|SUPERIORITY||Mean Difference (Final Values)|-2.48|STANDARD_DEVIATION|20.63||0.34|TWO_SIDED|95.0|-7.55|2.6|||t-test, 2 sided|||MSIS Physical||2.60|-7.55|0.34
72448029|NCT03468868|144413229|SUPERIORITY||Mean Difference (Final Values)|-1.38|STANDARD_DEVIATION|21.37||0.24|TWO_SIDED|95.0|-6.63|3.88|||t-test, 2 sided|||MSIS Psychological||3.88|-6.63|0.24
72448030|NCT03468868|144413230|SUPERIORITY||Mean Difference (Final Values)|0.37|STANDARD_DEVIATION|8.91||0.74|TWO_SIDED|95.0|-1.83|2.56|||t-test, 2 sided|||MFIS Cognitive||2.56|-1.83|0.74
72561531|NCT02102932|144653707|SUPERIORITY_OR_OTHER||Ratio of the geometric means|105.75|STANDARD_DEVIATION|13.2||0.0001|TWO_SIDED|90.0|99.09|112.85||P-value for ratio outside interval 80-125|ANOVA||Ratio of the geometric means for treatments (Test (T2) versus Reference (R2)) i.e. T2/R2. The standard deviation is actually the intra-individual gCV.|"The statistical model used was an analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation:~'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed."||112.85|99.09|0.0001
72448031|NCT03468868|144413230|SUPERIORITY||Mean Difference (Final Values)|-2.1|STANDARD_DEVIATION|8.03||0.04|TWO_SIDED|95.0|-4.07|-0.12|||t-test, 2 sided|||MFIS Physical||-0.12|-4.07|0.04
72448032|NCT03468868|144413230|SUPERIORITY||Mean Difference (Final Values)|-0.14|STANDARD_DEVIATION|2.17||0.59|TWO_SIDED|95.0|-0.68|0.39|||t-test, 2 sided|||MFIS Psychosocial||0.39|-0.68|0.59
72448033|NCT03468868|144413230|SUPERIORITY||Mean Difference (Final Values)|-1.88|STANDARD_DEVIATION|17.0||0.38|TWO_SIDED|95.0|-6.05|2.3|||t-test, 2 sided|||MFIS Total||2.30|-6.05|0.38
72448034|NCT03468868|144413231|SUPERIORITY||Mean Difference (Final Values)|-0.03|STANDARD_DEVIATION|1.18||0.87|TWO_SIDED|95.0|-0.34|0.29|||t-test, 2 sided|||||0.29|-0.34|0.87
72448035|NCT03468868|144413232|SUPERIORITY||Mean Difference (Final Values)|-0.54|STANDARD_DEVIATION|2.21||0.05|TWO_SIDED|95.0|-1.08|0.0|||t-test, 2 sided|||||0.00|-1.08|0.05
72448036|NCT05399459|144413233|SUPERIORITY||Adjusted percentage difference|19.4|||<|0.0001|TWO_SIDED|95.0|12.0|26.8|||Mantel Haenszel||Adjusted percentage difference (rimegepant 75 mg - placebo) stratified by randomization stratum with Mantel-Haenszel weighting.|||26.8|12.0|<0.0001
72448037|NCT05399459|144413234|SUPERIORITY||Adjusted percentage difference|22.7|||<|0.0001|TWO_SIDED|95.0|14.5|30.9|||Mantel Haenszel||Adjusted percentage difference (rimegepant 75 mg - placebo) stratified by randomization stratum with Mantel-Haenszel weighting.|||30.9|14.5|<0.0001
72448038|NCT05399459|144413235|SUPERIORITY||Adjusted percentage difference|14.8||||0.0011|TWO_SIDED|95.0|5.9|23.6|||Mantel Haenszel||Adjusted percentage difference (rimegepant 75 mg- placebo) stratified by randomization stratum with Mantel-Haenszel weighting.|||23.6|5.9|0.0011
72448039|NCT05399459|144413236|SUPERIORITY||Adjusted percentage difference|18.8|||<|0.0001|TWO_SIDED|95.0|10.1|27.4|||Mantel Haenszel||Adjusted percentage difference (rimegepant 75 mg- placebo) stratified by randomization stratum with Mantel-Haenszel weighting.|||27.4|10.1|<0.0001
72448040|NCT05399459|144413237|SUPERIORITY||Adjusted percentage difference|31.7|||<|0.0001|TWO_SIDED|95.0|23.2|40.3|||Mantel Haenszel||Adjusted percentage difference (rimegepant 75 mg- placebo) stratified by randomization stratum with Mantel-Haenszel weighting.|||40.3|23.2|<0.0001
72448041|NCT05399459|144413238|SUPERIORITY||Adjusted percentage difference|-19.7|||<|0.0001|TWO_SIDED|95.0|-27.8|-11.6|||Mantel Haenszel||Adjusted percentage difference (rimegepant 75 mg- placebo) stratified by randomization stratum with Mantel-Haenszel weighting.|||-11.6|-27.8|<0.0001
72448042|NCT05399459|144413239|SUPERIORITY||Adjusted percentage difference|33.1|||<|0.0001|TWO_SIDED|95.0|24.7|41.6|||Mantel Haenszel||Adjusted percentage difference (rimegepant 75 mg- placebo) stratified by randomization stratum with Mantel-Haenszel weighting.|||41.6|24.7|<0.0001
72448043|NCT05399459|144413240|SUPERIORITY||Adjusted percentage difference|10.1||||0.0707|TWO_SIDED|95.0|-0.9|21.1||P-value \> 0.05; therefore, all secondary outcome measures listed after this outcome measure in the hierarchy were not tested.|Mantel Haenszel||Adjusted percentage difference (rimegepant 75 mg- placebo) stratified by randomization stratum with Mantel-Haenszel weighting.|||21.1|-0.9|0.0707
72448044|NCT00986856|144413259|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|13.2|||<|0.01||95.0|1.4|120.4||Test for the hypothesis of odds ratio equal to 1.|Cochran-Mantel-Haenszel|||||120.4|1.4|<0.01
72448045|NCT00986856|144413260|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|5.7||||0.023||95.0|1.1|28.6|||Cochran-Mantel-Haenszel|||||28.6|1.1|0.023
72448046|NCT00986856|144413261|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.7||||0.54|TWO_SIDED|95.0|0.3|8.1|||Cochran-Mantel-Haenszel|||||8.1|0.3|0.54
72448047|NCT00986856|144413262|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.7||||0.1|TWO_SIDED|95.0|0.8|8.8|||Cochran-Mantel-Haenszel|||||8.8|0.8|0.1
72448048|NCT00986856|144413263|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1||95.0|||||Cochran-Mantel-Haenszel|||||||0.1
72448049|NCT00986856|144413264|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|8.5||||0.043||95.0|0.9|83.5|||Cochran-Mantel-Haenszel|||||83.5|0.9|0.043
72448050|NCT00986856|144413265|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|12.8||||0.007||95.0|1.5|109.6|||Cochran-Mantel-Haenszel|||||109.6|1.5|0.007
72448051|NCT00986856|144413266|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.8|STANDARD_DEVIATION|2.0||0.008||95.0|-4.8|-0.8|||Regression, Linear|||||-0.8|-4.8|0.008
72448052|NCT05583578|144413273|SUPERIORITY|||||||0.012||||||The Threshold for statistical significance was p=0.05|t-test, 2 sided|||||||0.012
72448053|NCT05583578|144413273|OTHER||Cohen's d (effect size)|0.98|||||TWO_SIDED||||||||Effect sizes greater than (d = 0.80) were considered large.|Post-intervention changes in walking speed||||
72448054|NCT05583578|144413274|SUPERIORITY|||||||0.39||||||The threshold for statistical significance was p = 0.05|t-test, 2 sided|||||||0.39
72448055|NCT05583578|144413274|SUPERIORITY||Cohen's d (effect size)|0.31|||||TWO_SIDED||||||||Effect sizes ranging from 0.21 to 0.79 were considered moderate, anything ≥0.80 were considered large.|||||
72448056|NCT04447469|144413275|SUPERIORITY||Odds Ratio (OR)|2.069||||0.2598|TWO_SIDED|95.0|0.555|8.615||P-value and odds ratio were calculated using Fisher's Exact test.|Fisher Exact|||||8.615|0.555|0.2598
72448057|NCT04447469|144413275|SUPERIORITY||Odds Ratio (OR)|2.414||||0.161|TWO_SIDED|95.0|0.653|9.957||P-value and odds ratio were calculated using Fisher's Exact test.|Fisher Exact|||||9.957|0.653|0.1610
72448058|NCT04447469|144413275|SUPERIORITY||Stratified Odds Ratio|2.091||||0.2448|TWO_SIDED|95.0|0.612|7.144||P-value and odds ratio were calculated using Cochran Mantel-Haenszel (CMH) test, stratified by randomization strata (standard of care antiretroviral therapy, age, and ARDS status).|Cochran-Mantel-Haenszel|||||7.144|0.612|0.2448
72448059|NCT04447469|144413275|SUPERIORITY||Stratified Odds Ratio|2.749||||0.1378|TWO_SIDED|95.0|0.756|9.993||P-value and odds ratio were calculated using Cochran Mantel-Haenszel (CMH) test, stratified by randomization strata (standard of care antiretroviral therapy, age, and ARDS status).|Cochran-Mantel-Haenszel|||||9.993|0.756|0.1378
72448060|NCT04447469|144413276|SUPERIORITY||Stratified Odds Ratio|1.231||||0.4534|TWO_SIDED|95.0|0.715|2.12||P-value and odds ratio were calculated using Cochran Mantel-Haenszel (CMH) test, stratified by randomization strata (age and ARDS status).|Cochran-Mantel-Haenszel|||||2.120|0.715|0.4534
72448061|NCT04447469|144413276|SUPERIORITY||Stratified Odds Ratio|1.097||||0.7414|TWO_SIDED|95.0|0.636|1.891||P-value and odds ratio were calculated using Cochran Mantel-Haenszel (CMH) test, stratified by randomization strata (age and ARDS status).|Cochran-Mantel-Haenszel|||||1.891|0.636|0.7414
72448062|NCT04447469|144413277|SUPERIORITY||Odds Ratio (OR)|0.984||||1|TWO_SIDED|95.0|0.198|4.884|||Fisher Exact|||||4.884|0.198|1.0000
72448063|NCT04447469|144413277|SUPERIORITY||Odds Ratio (OR)|1.286||||1|TWO_SIDED|95.0|0.26|6.417|||Fisher Exact|||||6.417|0.260|1.0000
72448064|NCT04447469|144413278|SUPERIORITY||Difference in Proportion|-15.0|||||TWO_SIDED|95.0|-45.6|15.6|||||95% CI were calculated using asymptotic normal approximation. Difference = KPL-301 - placebo.|||15.6|-45.6|
72448065|NCT04447469|144413278|SUPERIORITY||Difference in Proportions|-27.7|||||TWO_SIDED|95.0|-56.4|0.9|||||95% CI were calculated using asymptotic normal approximation. Difference = KPL-301 - Placebo .|||0.9|-56.4|
72448066|NCT04447469|144413279|SUPERIORITY|||||||0.6229||||||Log-rank test is stratified by randomization strata (Standard of Care antiretroviral therapy, age, and ARDS status).|Log Rank|||||||0.6229
72448067|NCT04447469|144413279|SUPERIORITY|||||||0.5526||||||Log-rank test is stratified by randomization strata (Standard of Care antiretroviral therapy, age, and ARDS status).|Log Rank|||||||0.5526
72619452|NCT00324857|144769879|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0||||"Please note that although the outcome is measured using a Likert scale, for the analysis we dichotomized the results.~P-value not adjusted for multiple comparison. Lastly, \<0.05 is the actual computed P-value."|Regression, Logistic|||Comparisons of the baseline demographic and clinical characteristics (TKR) across the 4 intervention groups were performed using chi-square tests for categorical data and analysis of variance for continuous variables. Willingness were compared across the groups over time using mixed-effect logistic regressions for dichotomous outcomes.||||<0.05
72619453|NCT01557244|144769895|SUPERIORITY|||||||0.0001|||||||ANCOVA|||P-value was calculated for change from Baseline at Week 12, based on an analysis of covariance (ANCOVA) model with terms for treatment group, baseline maximum cystometric bladder capacity and baseline weight.||||0.0001
72448068|NCT04447469|144413280|SUPERIORITY||Hazard Ratio (HR)|1.02||||0.9426|TWO_SIDED|80.0|0.71|1.46||Log-rank test is stratified by randomization strata (Standard of Care antiretroviral therapy, age, and ARDS status).|Log Rank||Calculated based on a Cox proportional-hazards model with treatment as covariate and stratified by randomization strata (Standard of Care antiretroviral therapy, age, and ARDS status).|||1.46|0.71|0.9426
72448069|NCT04447469|144413280|SUPERIORITY||Hazard Ratio (HR)|1.11||||0.6838|TWO_SIDED|80.0|0.78|1.57||Log-rank test is stratified by randomization strata (Standard of Care antiretroviral therapy, age, and ARDS status).|Log Rank||Calculated based on a Cox proportional-hazards model with treatment as covariate and stratified by randomization strata (Standard of Care antiretroviral therapy, age, and ARDS status).|||1.57|0.78|0.6838
72448070|NCT04447469|144413281|SUPERIORITY||Odds Ratio (OR)|0.235||||0.0905|TWO_SIDED|95.0|0.023|1.328|||Fisher Exact|||||1.328|0.023|0.0905
72448071|NCT04447469|144413281|SUPERIORITY||Odds Ratio (OR)|0.431||||0.2247|TWO_SIDED|95.0|0.087|1.815|||Fisher Exact|||||1.815|0.087|0.2247
72448072|NCT04447469|144413281|SUPERIORITY||Stratified Odds Ratio|0.191||||0.0623|TWO_SIDED|95.0|0.033|1.114||P-value and odds ratio were calculated using Cochran Mantel-Haenszel (CMH) test, stratified by randomization strata (standard of care antiretroviral therapy, age, and ARDS status).|Cochran-Mantel-Haenszel|||||1.114|0.033|0.0623
72561532|NCT02102932|144653707|SUPERIORITY_OR_OTHER||Ratio of the geometric means|102.9|STANDARD_DEVIATION|11.7||0|TWO_SIDED|90.0|97.11|109.03||P-value for ratio outside interval 80-125|ANOVA||Ratio of the geometric means for treatments (Test (T3) versus Reference (R3)) i.e. T3/R3. The standard deviation is actually the intra-individual gCV.|"The statistical model used was an analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation:~'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed."||109.03|97.11|0.0000
72561533|NCT02102932|144653707|SUPERIORITY_OR_OTHER||Ratio of the geometric means|93.84|STANDARD_DEVIATION|13.6||0.0002|TWO_SIDED|90.0|87.74|100.36||P-value for ratio outside interval 80-125|ANOVA||Ratio of the geometric means for treatments (Test (T4) versus Reference (R4)) i.e. T4/R4. The standard deviation is actually the intra-individual gCV.|"The statistical model used was an analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation:~'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed."||100.36|87.74|0.0002
72448073|NCT04447469|144413281|SUPERIORITY||Stratified Odds Ratio|0.368||||0.1957|TWO_SIDED|95.0|0.085|1.583||P-value and odds ratio were calculated using Cochran Mantel-Haenszel (CMH) test, stratified by randomization strata (standard of care antiretroviral therapy, age, and ARDS status).|Cochran-Mantel-Haenszel|||||1.583|0.085|0.1957
72448074|NCT04447469|144413282|SUPERIORITY||Hazard Ratio (HR)|1.57||||0.3766|TWO_SIDED|80.0|0.8|3.09||Log-rank test is stratified by randomization strata (Standard of Care antiretroviral therapy, and age).|Log Rank||Calculated based on a Cox proportional-hazards model with treatment as covariate and stratified by randomization strata (Standard of Care antiretroviral therapy and age).|||3.09|0.80|0.3766
72448075|NCT04447469|144413282|SUPERIORITY||Hazard Ratio (HR)|1.05||||0.9209|TWO_SIDED|80.0|0.51|2.16||Log-rank test is stratified by randomization strata (Standard of Care antiretroviral therapy, and age).|Log Rank||Calculated based on a Cox proportional-hazards model with treatment as covariate and stratified by randomization strata (Standard of Care antiretroviral therapy and age).|||2.16|0.51|0.9209
72448076|NCT04447469|144413283|SUPERIORITY||Stratified Odds Ratio|0.645||||0.1772|TWO_SIDED|95.0|0.34|1.222||Calculated using Cochran Mantel-Haenszel test, stratified by randomization strata (age and ARDS status).|Cochran-Mantel-Haenszel|||||1.222|0.340|0.1772
72619454|NCT01557244|144769895|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||P-value was calculated for change from Baseline at Week 12, based on ANCOVA model with terms for treatment group, baseline maximum cystometric bladder capacity and baseline weight.||||<.0001
72619455|NCT01557244|144769895|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline maximum cystometric bladder capacity and baseline weight.||||<.0001
72448077|NCT04447469|144413283|SUPERIORITY||Stratified Odds Ratio|1.029||||0.9269|TWO_SIDED|95.0|0.563|1.881||Calculated using Cochran Mantel-Haenszel test, stratified by randomization strata (age and ARDS status).|Cochran-Mantel-Haenszel|||||1.881|0.563|0.9269
72448078|NCT04447469|144413284|SUPERIORITY||Hazard Ratio (HR)|0.99||||0.9578|TWO_SIDED|95.0|0.66|1.49||Log-rank test is stratified by randomization strata (age, and ARDS status).|Log Rank||Calculated based on a Cox proportional-hazards model with treatment as covariate and stratified by randomization strata (age and ARDS status).|||1.49|0.66|0.9578
72448079|NCT04447469|144413284|SUPERIORITY||Hazard Ratio (HR)|1.14||||0.5274|TWO_SIDED|95.0|0.76|1.7||Log-rank test is stratified by randomization strata (age, and ARDS status).|Log Rank||Calculated based on a Cox proportional-hazards model with treatment as covariate and stratified by randomization strata (age and ARDS status).|||1.70|0.76|0.5274
72448080|NCT04447469|144413285|SUPERIORITY||Hazard Ratio (HR)|0.64||||0.1336|TWO_SIDED|95.0|0.36|1.15||Log-rank test is stratified by randomization strata (age, and ARDS status).|Log Rank||Calculated based on a Cox proportional-hazards model with treatment as covariate and stratified by randomization strata (age, and ARDS status).|||1.15|0.36|0.1336
72619456|NCT01557244|144769895|OTHER||Difference in Least square (LS) Mean|-29.06|||||TWO_SIDED|95.0|-71.42|13.31||||||||13.31|-71.42|
72619457|NCT01557244|144769895|OTHER||Difference in LS Mean|-3.82|||||TWO_SIDED|95.0|-45.87|38.23||||||||38.23|-45.87|
72448081|NCT04447469|144413285|SUPERIORITY||Hazard Ratio (HR)|1.01||||0.9767|TWO_SIDED|95.0|0.59|1.72||Log-rank test is stratified by randomization strata (age, and ARDS status).|Log Rank||Calculated based on a Cox proportional-hazards model with treatment as covariate and stratified by randomization strata ( age, and ARDS status).|||1.72|0.59|0.9767
72448082|NCT04447469|144413286|SUPERIORITY||Hazard Ratio (HR)|1.43|||||TWO_SIDED|95.0|0.55|3.71|||||Calculated based on a Cox proportional-hazards model with treatment as covariate and stratified by randomization strata (age).|||3.71|0.55|
72448083|NCT04447469|144413286|SUPERIORITY||Hazard Ratio (HR)|1.88|||||TWO_SIDED|95.0|0.78|4.54|||||Calculated based on a Cox proportional-hazards model with treatment as covariate and stratified by randomization strata (age).|||4.54|0.78|
72448084|NCT05201079|144413287|SUPERIORITY||Odds Ratio (OR)|2.395||||0.228|TWO_SIDED|97.79|0.54|10.624||Alpha: 0.0221|Regression, Logistic||Numerator: fidaxomicin; denominator: MBK-01|||10.624|0.540|0.228
72448085|NCT05201079|144413293|SUPERIORITY|||||||||||||||||Alpha value used: 0.0221|Statistical analysis using Odds Ratio cannot be performed because there are zero patients with bad progress in MBK-01 group.|||
72448086|NCT05201079|144413294|SUPERIORITY||Score (logrank) test|1.25||||0.3|TWO_SIDED|||||Alpha: 0.0221|Regression, Cox|Degrees of freedom: 1||||||0.300
72448087|NCT05201079|144413296|SUPERIORITY||Score (logrank) test|0.02||||0.9|TWO_SIDED|||||Alpha: 0.0221|Regression, Cox|Degrees of freedom: 1||||||0.900
72448088|NCT05201079|144413307|SUPERIORITY|||||||0.749||||||Main effect of the Group for the Physical Function area of the SF-36 questionnaire. F statistic (1,56) = 0.104.|ANOVA|||For each area of the SF-36 questionnaire, a mixed ANOVA for the effect of Group, Visit, and interaction effect of Group x Visit was performed. alpha = 0.0221.||||0.749
72448089|NCT05201079|144413307|SUPERIORITY|||||||0.62||||||Main effect of the Visit for the Physical Function area of the SF-36 questionnaire. F statistic (1,56) = 0.249.|ANOVA|||For each area of the SF-36 questionnaire, a mixed ANOVA for the effect of Group, Visit, and interaction effect of Group x Visit was performed. alpha = 0.0221.||||0.620
72448090|NCT05201079|144413307|SUPERIORITY|||||||0.16||||||Main effect of the Group x Visit interaction for the Physical Function area of the SF-36 questionnaire. F statistic (1,56) = 2.024.|ANOVA|||For each area of the SF-36 questionnaire, a mixed ANOVA for the effect of Group, Visit, and interaction effect of Group x Visit was performed. alpha = 0.0221.||||0.160
72448091|NCT05201079|144413307|SUPERIORITY|||||||0.614||||||Main effect of the Group for the Bodily pain area of the SF-36 questionnaire. F statistic (1,56) = 0.257.|ANOVA|||For each area of the SF-36 questionnaire, a mixed ANOVA for the effect of Group, Visit, and interaction effect of Group x Visit was performed. alpha = 0.0221.||||0.614
72448092|NCT05201079|144413307|SUPERIORITY|||||||0.007||||||Main effect of the Visit for the Bodily pain area of the SF-36 questionnaire. F statistic (1,56) = 7.705. Effect size = 0.046.|ANOVA|||For each area of the SF-36 questionnaire, a mixed ANOVA for the effect of Group, Visit, and interaction effect of Group x Visit was performed. alpha = 0.0221.||||0.007
72448093|NCT05201079|144413307|SUPERIORITY|||||||0.718||||||Main effect of the Group x Visit interaction for the Bodily pain area of the SF-36 questionnaire. F statistic (1,56) = 0.132.|ANOVA|||For each area of the SF-36 questionnaire, a mixed ANOVA for the effect of Group, Visit, and interaction effect of Group x Visit was performed. alpha = 0.0221.||||0.718
72448094|NCT05201079|144413307|SUPERIORITY|||||||0.494||||||Main effect of the Group for the General Health area of the SF-36 questionnaire. F statistic (1,56) = 0.474.|ANOVA|||For each area of the SF-36 questionnaire, a mixed ANOVA for the effect of Group, Visit, and interaction effect of Group x Visit was performed. alpha = 0.0221.||||0.494
72448095|NCT05201079|144413307|SUPERIORITY|||||||0.339||||||Main effect of the Visit for the General Health area of the SF-36 questionnaire. F statistic (1,56) = 0.932.|ANOVA|||For each area of the SF-36 questionnaire, a mixed ANOVA for the effect of Group, Visit, and interaction effect of Group x Visit was performed. alpha = 0.0221.||||0.339
72448096|NCT05201079|144413307|SUPERIORITY|||||||0.38||||||Main effect of the Group x Visit interaction for the General health area of the SF-36 questionnaire. F statistic (1,56) = 0.783.|ANOVA|||For each area of the SF-36 questionnaire, a mixed ANOVA for the effect of Group, Visit, and interaction effect of Group x Visit was performed. alpha = 0.0221.||||0.380
72448097|NCT05201079|144413307|SUPERIORITY|||||||0.79||||||Main effect of the Group for the Vitality area of the SF-36 questionnaire. F statistic (1,56) = 0.072|ANOVA|||For each area of the SF-36 questionnaire, a mixed ANOVA for the effect of Group, Visit, and interaction effect of Group x Visit was performed. alpha = 0.0221.||||0.790
72448098|NCT05201079|144413307|SUPERIORITY|||||||0.498||||||Main effect of the Visit for the Vitality area of the SF-36 questionnaire. F statistic (1,56) = 0.465.|ANOVA|||For each area of the SF-36 questionnaire, a mixed ANOVA for the effect of Group, Visit, and interaction effect of Group x Visit was performed. alpha = 0.0221.||||0.498
72448099|NCT05201079|144413307|SUPERIORITY|||||||0.023||||||Main effect of the Group x Visit interaction for the Vitality area of the SF-36 questionnaire. F statistic (1,56) = 5.490.|ANOVA|||For each area of the SF-36 questionnaire, a mixed ANOVA for the effect of Group, Visit, and interaction effect of Group x Visit was performed. alpha = 0.0221.||||0.023
72448100|NCT05201079|144413307|SUPERIORITY|||||||0.553||||||Main effect of the Group for the Social role area of the SF-36 questionnaire. F statistic (1,56) = 0.356.|ANOVA|||For each area of the SF-36 questionnaire, a mixed ANOVA for the effect of Group, Visit, and interaction effect of Group x Visit was performed. alpha = 0.0221.||||0.553
72448101|NCT05201079|144413307|SUPERIORITY|||||||0.718||||||Main effect of the Visit for the Social role area of the SF-36 questionnaire. F statistic (1,56) = 0.132.|ANOVA|||For each area of the SF-36 questionnaire, a mixed ANOVA for the effect of Group, Visit, and interaction effect of Group x Visit was performed. alpha = 0.0221.||||0.718
72448102|NCT05201079|144413307|SUPERIORITY|||||||0.574||||||Main effect of the Group x Visit interaction for the Social role area of the SF-36 questionnaire. F statistic (1,56) = 0.319.|ANOVA|||For each area of the SF-36 questionnaire, a mixed ANOVA for the effect of Group, Visit, and interaction effect of Group x Visit was performed. alpha = 0.0221.||||0.574
72561534|NCT02250651|144653729|NON_INFERIORITY|MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.|Least-squares Mean Difference|-0.36|STANDARD_ERROR_OF_MEAN|0.41||0.3738|TWO_SIDED|95.0|-1.17|0.44|||MMRM|||Change from Baseline at Week 12, Hour 0: The hypothesis was that bimatoprost SR 15 μg was to be declared non-inferior to timolol 0.5% if the upper limit of the 95% CI was ≤ 1.5 mmHg for all scheduled timepoints (Hours 0 and 2 at Week 12).||0.44|-1.17|0.3738
72448103|NCT05201079|144413307|SUPERIORITY|||||||0.49||||||Main effect of the Group for the Emotional role area of the SF-36 questionnaire. F statistic (1,56) = 0.482.|ANOVA|||For each area of the SF-36 questionnaire, a mixed ANOVA for the effect of Group, Visit, and interaction effect of Group x Visit was performed. alpha = 0.0221.||||0.490
72448104|NCT05201079|144413307|SUPERIORITY|||||||0.032||||||Main effect of the Visit for the Emotional role area of the SF-36 questionnaire. F statistic (1,56) = 4.850|ANOVA|||For each area of the SF-36 questionnaire, a mixed ANOVA for the effect of Group, Visit, and interaction effect of Group x Visit was performed. alpha = 0.0221.||||0.032
72448105|NCT05201079|144413307|SUPERIORITY|||||||0.145||||||Main effect of the Group x Visit interaction for the Emotional role area of the SF-36 questionnaire. F statistic (1,56) = 2.181.|ANOVA|||For each area of the SF-36 questionnaire, a mixed ANOVA for the effect of Group, Visit, and interaction effect of Group x Visit was performed. alpha = 0.0221.||||0.145
72448106|NCT05201079|144413307|SUPERIORITY|||||||0.467||||||Main effect of the Group for the Mental health area of the SF-36 questionnaire. F statistic (1,56) = 0.535.|ANOVA|||For each area of the SF-36 questionnaire, a mixed ANOVA for the effect of Group, Visit, and interaction effect of Group x Visit was performed. alpha = 0.0221.||||0.467
72448107|NCT05201079|144413307|SUPERIORITY|||||||0.1||||||Main effect of the Visit for the Mental health area of the SF-36 questionnaire. F statistic (1,56) = 2.795|ANOVA|||For each area of the SF-36 questionnaire, a mixed ANOVA for the effect of Group, Visit, and interaction effect of Group x Visit was performed. alpha = 0.0221.||||0.100
72448108|NCT05201079|144413307|SUPERIORITY|||||||0.89||||||Main effect of the Group x Visit interaction for the Mental health area of the SF-36 questionnaire. F statistic (1,56) = 0.019.|ANOVA|||For each area of the SF-36 questionnaire, a mixed ANOVA for the effect of Group, Visit, and interaction effect of Group x Visit was performed. alpha = 0.0221.||||0.890
72448109|NCT05201079|144413307|SUPERIORITY|||||||0.742||||||Main effect of the Group for the Physical Role area of the SF-36 questionnaire. F statistic (1,56) = 0.109.|ANOVA|||For each area of the SF-36 questionnaire, a mixed ANOVA for the effect of Group, Visit, and interaction effect of Group x Visit was performed. alpha = 0.0221.||||0.742
72448110|NCT05201079|144413307|SUPERIORITY||||||<|0.001||||||Main effect of the Visit for the Physical Role area of the SF-36 questionnaire. F statistic (1,56) = 21.912. Effect size = 0.109.|ANOVA|||For each area of the SF-36 questionnaire, a mixed ANOVA for the effect of Group, Visit, and interaction effect of Group x Visit was performed. alpha = 0.0221.||||<0.001
72448111|NCT05201079|144413307|SUPERIORITY|||||||0.089||||||Main effect of the Group x Visit interaction for the Physical Role area of the SF-36 questionnaire. F statistic (1,56) = 2.986.|ANOVA|||For each area of the SF-36 questionnaire, a mixed ANOVA for the effect of Group, Visit, and interaction effect of Group x Visit was performed. alpha = 0.0221.||||0.089
72448112|NCT04752709|144413324|OTHER||||||<|0.0001|TWO_SIDED|95.0|||||t-test, 2 sided|||||||<0.0001
72448113|NCT00324805|144413388|SUPERIORITY||Hazard Ratio (HR)|0.99||||0.9|TWO_SIDED|95.0|0.82|1.19|||Regression, Cox||Arm II versus Arm I|||1.19|0.82|0.90
72448114|NCT00324805|144413389|SUPERIORITY||Hazard Ratio (HR)|0.99||||0.95|TWO_SIDED|95.0|0.86|1.15|||Regression, Cox||Arm II vs. Arm I|||1.15|0.86|0.95
72448115|NCT05778695|144413409|OTHER|A comparison is not being made between two different treatment groups. Exploratory analysis|Median Difference (Net)|-14.0|STANDARD_DEVIATION|22.02||0.875|TWO_SIDED|||||A priori threshold for statistical significance is p \< 0.05.|Wilcoxon (Mann-Whitney)|||||||0.875
72448116|NCT05778695|144413409|OTHER|A comparison is not being made between two different treatment groups. Exploratory analysis|Mean Difference (Net)|-2.0|STANDARD_DEVIATION|15.166||0.739|TWO_SIDED|95.0|-16.026|12.026||A priori threshold for statistical significance is p \< 0.05.|t-test, 2 sided|||||12.026|-16.026|0.739
72448117|NCT05778695|144413410|OTHER|A comparison is not being made between two different treatment groups. Exploratory analysis|Median Difference (Net)|0.0|STANDARD_DEVIATION|0.34||0.37|TWO_SIDED|||||A priori threshold for statistical significance is p \< 0.05.|Wilcoxon (Mann-Whitney)|||||||0.37
72448118|NCT01733316|144413427|SUPERIORITY|||||||0.0048||||||Paired t-test testing the null hypothesis that the population average difference during the Cystagon® phase is equal to the population average difference during the RP103 phase.|Paired t-test, two-sided|||||||0.0048
72448119|NCT01674140|144413444|SUPERIORITY||Hazard Ratio (HR)|0.94||||0.52|TWO_SIDED|95.0|0.77|1.14|||Log Rank|||||1.14|0.77|0.52
72448120|NCT01674140|144413445|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.84|TWO_SIDED|95.0|0.75|1.26|||Log Rank|||||1.26|0.75|0.84
72448121|NCT01674140|144413447|SUPERIORITY||Hazard Ratio (HR)|0.9||||0.32|TWO_SIDED|95.0|0.74|1.1|||Log Rank|||||1.10|0.74|0.32
72448122|NCT03381196|144413450|SUPERIORITY|||||||0.0216|||||||Gehan-Wilcoxon test|||||||0.0216
72448123|NCT01574274|144413497|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.00
72448124|NCT01574274|144413498|SUPERIORITY|||||||0.07|||||||t-test, 2 sided|||Day 4 NSAA Level||||0.07
72448125|NCT01574274|144413498|SUPERIORITY|||||||0.29|||||||t-test, 2 sided|||Day 11 NSAA Level||||0.29
72448126|NCT01574274|144413498|SUPERIORITY|||||||0.0002|||||||t-test, 2 sided|||Day 18 NSAA Level||||0.0002
72448127|NCT01574274|144413498|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||Day 25 NSAA Level||||<0.0001
72448128|NCT01574274|144413498|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||Week 7 NSAA Level||||<0.0001
72448129|NCT01574274|144413498|SUPERIORITY|||||||0.87|||||||t-test, 2 sided|||Week 13 NSAA Level||||0.87
72448130|NCT01574274|144413498|SUPERIORITY|||||||0.83|||||||t-test, 2 sided|||Week 19 NSAA Level||||0.83
72448131|NCT01574274|144413498|SUPERIORITY|||||||0.94|||||||t-test, 2 sided|||Week 25 NSAA Level||||0.94
72448132|NCT05089019|144413506|EQUIVALENCE|Equivalence margin 80% to 125%|Ratio of Geometric LS Mean|0.889|||||TWO_SIDED|94.12|0.81|0.976|||Mixed Models Analysis|Ratio of Geometric Least Square (LS) Mean||||0.976|0.810|
72448133|NCT05089019|144413507|EQUIVALENCE|Equivalence margin 80% to 125%.|Ratio of Geometric LS Mean|0.927|||||TWO_SIDED|94.12|0.882|0.975|||Mixed Models Analysis|||||0.975|0.882|
72448134|NCT05089019|144413508|EQUIVALENCE|Equivalence margin 80% to 125%|Ratio of Geometric LS Mean|0.891|||||TWO_SIDED|94.12|0.834|0.951|||Mixed Models Analysis|||||0.951|0.834|
72448135|NCT05530603|144413524|OTHER|||||||0.009||||||The threshold for statistical significance was p=0.05.|Chi-squared|||||||.009
72448136|NCT05530603|144413525|OTHER||Mean Difference (Net)|1.12|STANDARD_DEVIATION|0.8||0.73|TWO_SIDED|||||The threshold for statistical significance was p=0.05.|ANOVA|||||||0.730
72448137|NCT05530603|144413526|OTHER|||||||0.033||||||The threshold for statistical significance was p=0.05.|ANOVA|||||||.033
72448138|NCT05530603|144413527|OTHER|||||||0.068|||||||ANOVA|The threshold for statistical significance was p=0.05.||||||.068
72448139|NCT05530603|144413528|OTHER|||||||0.001||||||The threshold for statistical significance was p=0.05.|Fisher Exact|||||||.001
72448140|NCT05530603|144413529|OTHER|||||||0.001||||||The threshold for statistical significance was p=0.05.|t-test, 2 sided|||||||.001
72448141|NCT05530603|144413530|OTHER|||||||0.001||||||The threshold for statistical significance was p=0.05.|t-test, 2 sided|||||||.001
72448142|NCT02043678|144413531|SUPERIORITY||Hazard Ratio (HR)|1.122||||0.2636|TWO_SIDED|95.0|0.917|1.374|||Cox Proportional Hazards Model|||||1.374|0.917|0.2636
72448143|NCT02043678|144413532|SUPERIORITY||Hazard Ratio (HR)|1.151||||0.1194|TWO_SIDED|95.0|0.964|1.374|||Cox Proportional Hazards model|||||1.374|0.964|0.1194
72448144|NCT02043678|144413533|SUPERIORITY||Hazard Ratio (HR)|1.152||||0.1283|TWO_SIDED|95.0|0.96|1.383|||Cox Proportional Hazards Model|||||1.383|0.960|0.1283
72448145|NCT02043678|144413534|SUPERIORITY||Hazard Ratio (HR)|1.145||||0.1669|TWO_SIDED|95.0|0.945|1.389|||Cox Proportional Hazards Model|||||1.389|0.945|0.1669
72448146|NCT02043678|144413535|SUPERIORITY||Hazard Ratio (HR)|1.033||||0.7871|TWO_SIDED|95.0|0.816|1.308|||Cox Proportional Hazards Model|||||1.308|0.816|0.7871
72448147|NCT02043678|144413536|SUPERIORITY||Hazard Ratio (HR)|1.126||||0.2467|TWO_SIDED|95.0|0.921|1.378|||Cox Proportional Hazards Model|||||1.378|0.921|0.2467
72561535|NCT02250651|144653729|NON_INFERIORITY|MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.|Least-squares Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.41||0.8514|TWO_SIDED|95.0|-0.88|0.73|||MMRM|||Change from Baseline at Week 12, Hour 0: The hypothesis was that bimatoprost SR 10 μg was to be declared non-inferior to timolol 0.5% if the upper limit of the 95% CI was ≤ 1.5 mmHg for all scheduled timepoints (Hours 0 and 2 at Week 12).||0.73|-0.88|0.8514
72448148|NCT03216057|144413557|SUPERIORITY|The sample size was calculated that 130 subjects randomized in a 1:1 fashion between the 2 arms have 85% power to detect a difference of at least 20% in triglyceride percentage changes compared with placebo at week 12, assuming a common standard deviation in percentage change of 35%, a 2-sided α = 0.05, and we add 20% for lost follow-up, finally the number of subjects for each arm was 65.|Mean Difference (Net)|-24.5|||<|0.01|TWO_SIDED|95.0|-32.7|-16.2|||t-test, 2 sided|||||-16.2|-32.7|<0.01
72448149|NCT03216057|144413558|SUPERIORITY||Mean Difference (Net)|-59.9|||<|0.01|TWO_SIDED|95.0|-83.0|-36.8|||t-test, 2 sided|||||-36.8|-83.0|<0.01
72448150|NCT03216057|144413559|SUPERIORITY||Mean Difference (Net)|-9.0||||0.01|TWO_SIDED|95.0|-16.1|-1.9|||t-test, 2 sided|||||-1.9|-16.1|0.01
72448151|NCT03216057|144413560|SUPERIORITY||Mean Difference (Net)|-4.9||||0.3|TWO_SIDED|95.0|-15.8|6.05|||t-test, 2 sided|||||6.05|-15.8|0.3
72448152|NCT03216057|144413561|SUPERIORITY||Mean Difference (Net)|-12.4|||<|0.01|TWO_SIDED|95.0|-21.2|-3.5|||t-test, 2 sided|||||-3.5|-21.2|<0.01
72448153|NCT03216057|144413562|SUPERIORITY||Mean Difference (Net)|-2.2||||0.02|TWO_SIDED|95.0|-4.1|-0.3|||t-test, 2 sided|||||-0.3|-4.1|0.02
72448154|NCT03216057|144413563|SUPERIORITY||Mean Difference (Net)|-1.2||||0.6|TWO_SIDED|95.0|-6.3|3.8|||t-test, 2 sided|||||3.8|-6.3|0.6
72448155|NCT03216057|144413564|SUPERIORITY||Mean Difference (Net)|1.9||||0.1|TWO_SIDED|95.0|-0.9|4.9|||t-test, 2 sided|||||4.9|-0.9|0.1
72448156|NCT03216057|144413565|SUPERIORITY||Mean Difference (Net)|13.4|||<|0.01|TWO_SIDED|95.0|5.8|21.0|||t-test, 2 sided|||||21|5.8|<0.01
72448157|NCT03216057|144413566|SUPERIORITY||Mean Difference (Net)|0.8|||<|0.01|TWO_SIDED|95.0|0.4|1.2|||t-test, 2 sided|||||1.2|0.4|<0.01
72448158|NCT04568603|144413567|EQUIVALENCE|The hypothesis that administration of methadone + ISL is similar to the methadone alone will be supported if the 90% CI for the geometric mean ratio (GMR) of methadone+ ISL to methadone alone is contained within the interval (0.70, 1.43).|GMR|1.03|||||TWO_SIDED|90.0|1.0|1.07||||||||1.07|1.00|
72448159|NCT04568603|144413568|EQUIVALENCE|The hypothesis that administration of methadone + ISL is similar to the methadone alone will be supported if the upper bound of the 90% CI for the GMR of methadone+ ISL to methadone alone is below 2.0.|GMR|1.03|||||TWO_SIDED|90.0|0.99|1.07||||||||1.07|0.99|
72448160|NCT04568603|144413569|EQUIVALENCE|The hypothesis that administration of methadone + ISL is similar to the methadone alone will be supported if the upper bound of the 90% CI for the GMR of methadone+ ISL to methadone alone is below 1.43.|GMR|1.02|||||TWO_SIDED|90.0|0.96|1.09||||||||1.09|0.96|
72619458|NCT01557244|144769896|SUPERIORITY|||||||0.2334|||||||ANCOVA|||P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline detrusor pressure at maximum bladder capacity and baseline weight.||||0.2334
72448161|NCT04568603|144413570|EQUIVALENCE|The hypothesis that administration of methadone + ISL is similar to methadone alone will be supported if the upper bound of the 90% CI for the GMR of methadone+ ISL to methadone alone is below 2.0.|GMR|1.06|||||TWO_SIDED|90.0|1.03|1.1||||||||1.10|1.03|
72448162|NCT04568603|144413572|EQUIVALENCE|The hypothesis that administration of methadone + ISL is similar to methadone alone will be supported if the upper bound of the 90% CI for the GMR of methadone+ ISL to methadone alone is below 2.0.|GMR|1.01|||||TWO_SIDED|90.0|0.94|1.09||||||||1.09|0.94|
72448163|NCT04568603|144413573|EQUIVALENCE|The hypothesis that administration of methadone + ISL is similar to methadone alone will be supported if the upper bound of the 90% CI for the GMR of methadone+ ISL to methadone alone is below 2.0.|GMR|1.08|||||TWO_SIDED|90.0|1.04|1.13||||||||1.13|1.04|
72448164|NCT04568603|144413575|EQUIVALENCE|The hypothesis that administration of methadone + ISL is similar to methadone alone will be supported if the upper bound of the 90% CI for the GMR of methadone+ ISL to methadone alone is below 2.0.|GMR|1.03|||||TWO_SIDED|90.0|0.99|1.07||||||||1.07|0.99|
72448165|NCT04568603|144413576|EQUIVALENCE|The hypothesis that administration of methadone + ISL is similar to methadone alone will be supported if the upper bound of the 90% CI for the GMR of methadone+ ISL to methadone alone is below 2.0.|GMR|1.01|||||TWO_SIDED|90.0|0.95|1.08||||||||1.08|0.95|
72448166|NCT04568603|144413577|EQUIVALENCE|The hypothesis that administration of methadone + ISL is similar to methadone alone will be supported if the upper bound of the 90% CI for the GMR of methadone+ ISL to methadone alone is below 2.0.|GMR|1.07|||||TWO_SIDED|90.0|1.03|1.11||||||||1.11|1.03|
72619459|NCT01557244|144769896|SUPERIORITY|||||||0.5087|||||||ANCOVA|||P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline detrusor pressure at maximum bladder capacity and baseline weight.||||0.5087
72448167|NCT04564742|144413581|SUPERIORITY||Win Ratio (WR)|1.34|||<|0.001|TWO_SIDED|95.0|1.2|1.5||A closed testing procedure including a pre-specified hierarchical ordering of the primary and secondary endpoints was utilised. No multiplicity control was placed on the exploratory endpoints.|Win Ratio Analysis|||The primary objective of the study was to determine if the clinical benefit of dapagliflozin was superior as compared with placebo, utilizing a hierarchical composite endpoint and win-ratio (WR) method. With a presumed WR of 1.20, 4000 patients were provide an 80% statistical power for the primary endpoint, maintaining a 1:1 allocation between treatments. The primary analysis was based on the intention-to-treat principle using the Full Analysis Set.||1.50|1.20|<0.001
72448168|NCT03313076|144413589|SUPERIORITY||Slope|-0.84||||0.276|TWO_SIDED|95.0|-2.32|0.63||"The final, adjusted p-value threshold of 0.0492, using the O'Brien-Fleming approach, allows for a statistical penalty to be assessed because of the interim analysis."|Mixed Models Analysis|The model was adjusted for age, sex, race, treatment interaction, initial pain severity, and total body surface area burned.||||0.63|-2.32|0.276
72448169|NCT03313076|144413589|SUPERIORITY||Slope|0.72||||0.336|TWO_SIDED|95.0|-0.71|2.14||"The final, adjusted p-value threshold of 0.0492, using the O'Brien-Fleming approach, allows for a statistical penalty to be assessed because of the interim analysis."|Mixed Models Analysis|The model was adjusted for age, sex, race, treatment interaction, initial pain severity, and total body surface area burned.||||2.14|-0.71|0.336
72448170|NCT03313076|144413589|SUPERIORITY||Slope|-2.33||||0.004|TWO_SIDED|95.0|-3.76|-0.9||"The final, adjusted p-value threshold of 0.0492, using the O'Brien-Fleming approach, allows for a statistical penalty to be assessed because of the interim analysis."|Mixed Models Analysis|The model was adjusted for age, sex, race, treatment interaction, initial pain severity, and total body surface area burned.||Sensitivity analysis adjusting for an influential observation (using the dfbeta approach) that could produce spurious results from a small trial dataset||-0.9|-3.76|0.004
72448171|NCT03313076|144413589|SUPERIORITY||Slope|0.92||||0.139|TWO_SIDED|95.0|-0.25|2.09||"The final, adjusted p-value threshold of 0.0492, using the O'Brien-Fleming approach, allows for a statistical penalty to be assessed because of the interim analysis."|Mixed Models Analysis|The model was adjusted for age, sex, race, treatment interaction, initial pain severity, and total body surface area burned.||Sensitivity analysis adjusting for an influential observation (using the dfbeta approach) that could produce spurious results from a small trial dataset||2.09|-0.25|0.139
72448172|NCT05448105|144413634|SUPERIORITY|||||||0.02|||||||Wilcoxon signed rank test|"Wilcoxon signed rank test comparing the participants' SUS scores to the threshold value of 71 indicative of good usability."||||||0.02
72448173|NCT05448105|144413637|OTHER|||||||0.04|||||||paired Wilcoxon signed-rank sum test|||||||0.04
72448174|NCT05448105|144413638|OTHER||||||<|0.01||||||This is calculated p-value. The threshold for significance was less than 0.05.|paired Wilcoxon signed-rank sum test|||||||<0.01
72448175|NCT05448105|144413639|OTHER|||||||0.16|||||||paired Wilcoxon signed-rank sum test|||||||0.16
72448176|NCT05448105|144413640|OTHER|||||||0.69|||||||paired Wilcoxon signed-rank sum test|||||||0.69
72448177|NCT05448105|144413641|OTHER|||||||0.9|||||||paired Wilcoxon signed-rank sum test|||||||0.90
72561536|NCT02250651|144653729|NON_INFERIORITY|MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.|Least-squares Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.39||0.0401|TWO_SIDED|95.0|-1.57|-0.04|||MMRM|||Change from Baseline at Week 12, Hour 2: The hypothesis was that bimatoprost SR 15 μg was to be declared non-inferior to timolol 0.5% if the upper limit of the 95% CI was ≤ 1.5 mmHg for all scheduled timepoints (Hours 0 and 2 at Week 12).||-0.04|-1.57|0.0401
72619460|NCT01557244|144769896|SUPERIORITY|||||||0.3333|||||||ANCOVA|||P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline detrusor pressure at maximum bladder capacity and baseline weight.||||0.3333
72448178|NCT05448105|144413642|OTHER|||||||0.11|||||||paired Wilcoxon signed-rank sum test|||||||0.11
72619461|NCT01557244|144769896|OTHER||Difference in LS Mean|-0.47|||||TWO_SIDED|95.0|-7.28|6.33||||||||6.33|-7.28|
72448179|NCT05448105|144413643|OTHER|||||||0.22|||||||paired Wilcoxon signed-rank sum test|||||||0.22
72448180|NCT05448105|144413644|OTHER|||||||1||||||This is the calculated p-value.|McNemar|||Analysis for pre-post change in knowledge of definition of A1C||||1.00
72448181|NCT05448105|144413644|OTHER|||||||0.55|||||||McNemar|||Analysis for pre-post change in knowledge of goal range for hemoglobin A1c.||||0.55
72448182|NCT05448105|144413644|OTHER|||||||0.11|||||||McNemar|||Analysis for pre-post change in knowledge of definition of systolic blood pressure||||0.11
72448183|NCT05448105|144413644|OTHER|||||||0.63|||||||McNemar|||Analysis of pre-post change in knowledge of goal range for systolic blood pressure||||0.63
72448184|NCT05448105|144413644|OTHER|||||||0.12|||||||McNemar|||Analysis of pre-post change in knowledge of definition of LDL cholesterol||||0.12
72448185|NCT05448105|144413644|OTHER|||||||0.33|||||||McNemar|||Analysis for pre-post change in knowledge of goal range for LDL cholesterol||||0.33
72448186|NCT05448105|144413644|OTHER|||||||0.23|||||||McNemar|||Analysis of pre-post change in knowledge of definition of urine microalbumin||||0.23
72448187|NCT05448105|144413644|OTHER|||||||0.58|||||||McNemar|||Analysis for pre-post change in knowledge of goal range for urine microalbumin||||0.58
72448188|NCT05448105|144413644|OTHER|||||||1|||||||McNemar|||Analysis of pre-post change in knowledge of definition of body mass index (BMI)||||1.00
72448189|NCT05448105|144413644|OTHER|||||||0.27|||||||McNemar|||Analysis for pre-post change in knowledge of goal range for body mass index (BMI)||||0.27
72448190|NCT05270408|144413646|SUPERIORITY||Cohen's d|0.93||||0.25|TWO_SIDED||||||ANCOVA|||RAVLT Total Learning||||0.25
72448191|NCT05270408|144413646|SUPERIORITY||Cohen's d|0.69||||0.18|TWO_SIDED||||||ANCOVA|||RAVLT Total Learning||||0.18
72448192|NCT05270408|144413646|SUPERIORITY||Cohen's d|0.74||||0.48|TWO_SIDED||||||ANCOVA|||RAVLT Delayed||||0.48
72448193|NCT05270408|144413646|SUPERIORITY||Cohen's d|0.19||||0.64|TWO_SIDED||||||ANCOVA|||RAVLT Delayed||||0.64
72448194|NCT05270408|144413647|SUPERIORITY||Cohen's d|0.03||||0.98|TWO_SIDED||||||ANCOVA|||BVMT total learning||||0.98
72448195|NCT05270408|144413647|SUPERIORITY||Cohen's d|0.86||||0.22|TWO_SIDED||||||ANCOVA|||BVMT total learning||||0.22
72619462|NCT01557244|144769896|OTHER||Difference in LS Mean|0.82|||||TWO_SIDED|95.0|-5.96|7.6||||||||7.60|-5.96|
72448196|NCT05270408|144413647|SUPERIORITY||Cohen's d|0.04||||0.97|TWO_SIDED||||||ANCOVA|||BVMT delayed||||0.97
72448197|NCT05270408|144413647|SUPERIORITY||Cohen's d|0.69||||0.23|TWO_SIDED||||||ANCOVA|||BVMT delayed||||0.23
72448198|NCT05270408|144413648|SUPERIORITY||Cohen's d|0.04||||0.94|TWO_SIDED||||||ANCOVA|||||||0.94
72448199|NCT05270408|144413648|SUPERIORITY||Cohen's d|0.42||||0.47|TWO_SIDED||||||ANCOVA|||||||0.47
72448200|NCT05270408|144413649|SUPERIORITY||Cohen's d|1.49||||0.06|TWO_SIDED||||||ANCOVA|||||||0.06
72448201|NCT05270408|144413649|SUPERIORITY||Cohen's d|1.08||||0.07|TWO_SIDED||||||ANCOVA|||||||0.07
72619463|NCT01557244|144769898|SUPERIORITY|||||||0.0336|||||||ANCOVA|||P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline bladder volume at first IDC and baseline weight.||||0.0336
72448202|NCT05270408|144413650|SUPERIORITY||Cohen's d|0.19||||0.61|TWO_SIDED||||||ANCOVA|||||||0.61
72448203|NCT05270408|144413650|SUPERIORITY||Cohen's d|0.68||||0.38|TWO_SIDED||||||ANCOVA|||||||0.38
72448204|NCT05270408|144413652|SUPERIORITY||Cohen's d|0.96||||0.11|TWO_SIDED||||||ANCOVA|||||||0.11
72448205|NCT05270408|144413652|SUPERIORITY|||||||0.68|||||||ANCOVA||||Eta2 effect sizes produced from the pairwise comparisons were transformed to Cohen's d for examination of effect sizes. A small/weak effect size was demonstrated (Cohen's d = 0.10), when adjusting for baseline performance.|||0.68
72448206|NCT02465268|144413655|SUPERIORITY||Hazard Ratio (HR)|1.29||||0.196|TWO_SIDED|95.0|0.77|2.16|||Log Rank|||||2.16|0.77|0.196
72448207|NCT02465268|144413655|SUPERIORITY||Hazard Ratio (HR)|1.63||||0.196|TWO_SIDED|95.0|0.99|2.7|||Log Rank|||||2.70|0.99|0.196
72504794|NCT03114969|144540512|SUPERIORITY||Odds Ratio (OR)|3.25||||0.166|TWO_SIDED|95.0|0.612|17.244||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta+\[Relvar Ellipta+LAMA\] as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.|||17.244|0.612|0.166
72448208|NCT02465268|144413656|SUPERIORITY||Hazard Ratio (HR)|0.98||||0.354|TWO_SIDED|95.0|0.6|1.61|||Log Rank|||||1.61|0.60|0.354
72448209|NCT02465268|144413656|SUPERIORITY||Hazard Ratio (HR)|1.42||||0.354|TWO_SIDED|95.0|0.87|2.33|||Log Rank|||||2.33|0.87|0.354
72448210|NCT02465268|144413657|SUPERIORITY|||||||0.038|||||||Kruskal-Wallis|||||||0.038
72448211|NCT02465268|144413657|SUPERIORITY|||||||0.038|||||||Kruskal-Wallis|||||||0.038
72448212|NCT02465268|144413657|SUPERIORITY|||||||0.038|||||||Kruskal-Wallis|||||||0.038
72448213|NCT02465268|144413659|SUPERIORITY|||||||0.2|||||||Kruskal-Wallis|||||||0.2
72448214|NCT02465268|144413659|SUPERIORITY|||||||0.2|||||||Kruskal-Wallis|||||||0.2
72448215|NCT02465268|144413659|SUPERIORITY|||||||0.2|||||||Kruskal-Wallis|||||||0.2
72448216|NCT02465268|144413660|SUPERIORITY|||||||0.6|||||||Kruskal-Wallis|||||||0.6
72448217|NCT02465268|144413660|SUPERIORITY|||||||0.6|||||||Kruskal-Wallis|||||||0.6
72448218|NCT02465268|144413660|OTHER|||||||0.6|||||||Kruskal-Wallis|||||||0.6
72448219|NCT02465268|144413662|SUPERIORITY|||||||0.13|||||||Kruskal-Wallis|||||||0.13
72448220|NCT02465268|144413662|SUPERIORITY|||||||0.13|||||||Kruskal-Wallis|||||||0.13
72448221|NCT02465268|144413662|SUPERIORITY|||||||0.13|||||||Kruskal-Wallis|||||||0.13
72448222|NCT06074172|144413680|OTHER|Linear Mixed Models were done with a compound symmetry covariance structure. This infers that the variances (pooled within-group) and covariances (across subjects) of all of the repeated measures are homogenous.||||||0.008||||||In the Bonferroni corrected Linear Mixed Model for PI Ratio, the p-value for the following interaction was reported: Treatment\*Age.|Linear Mixed Model|"Linear Mixed Model analyses:~1. Factor: Treatment group~2. Covariates: Age, Sex, CBD Use history, and Urine THC~3. Interactions"||||||0.008
72448223|NCT03020199|144413684|SUPERIORITY||Odds Ratio (OR)|16.8|||<|0.0001|TWO_SIDED|95.0|5.9|48.3|||Regression, Logistic||Logistic regression model with treatment as an explanatory variable and subset of significant covariates (including Baseline PASI score, age, BMI and their interaction terms with treatment) selected using forward selection method.|Week 52 PASI 90||48.3|5.9|<0.0001
72448224|NCT03020199|144413685|SUPERIORITY||Odds Ratio (OR)|0.8||||0.653|TWO_SIDED|95.0|0.3|2.1|||Regression, Logistic||Exact logistic regression method for Treatment group comparison, without using any covariates.|Week 104 PASI 90||2.1|0.3|0.6530
72448225|NCT04005794|144413687|OTHER|||||||0.004||||||Social latency t = 3.215|t-test, 2 sided|||||||0.004
72448226|NCT04005794|144413688|OTHER|||||||0.213|||||||ANOVA|||||||0.213
72448227|NCT04005794|144413689|OTHER|||||||0.01|||||||ANOVA|||||||0.01
72448228|NCT04005794|144413690|OTHER|||||||0.004|||||||ANOVA|||||||0.004
72448229|NCT04005794|144413691|OTHER||||||>|0.05|||||||ANOVA|||||||>0.05
72448230|NCT05386030|144413718|NON_INFERIORITY|The hypothesis to be tested was: H0: pA-pB ≤ d0 versus H1: pA-pB\> d0 where, pA is the response rate for saypha® VOLUME Lidocaine, pB is the response rate for the Comparator, and d0 is the non-inferiority margin set at -10%. The hypothesis was tested based on Farrington-Manning-statistics with a one-sided type I error rate level of 0.025.|||||<|0.0001||||||Confirmatory testing will be performed in a hierarchical ordering: First analysis will be performed on the per protocol dataset, and if the corresponding p-value is below 0.025, the analysis will be performed on the full analysis dataset.|Farrington-Manning test|||||||<0.0001
72448231|NCT05386030|144413719|NON_INFERIORITY|The hypothesis to be tested was: H0: pA-pB ≤ d0 versus H1: pA-pB\> d0 where, pA is the response rate for saypha® VOLUME Lidocaine, pB is the response rate for the Comparator, and d0 is the non-inferiority margin set at -10%. The hypothesis was tested based on Farrington-Manning-statistics with a one-sided type I error rate level of 0.025.|||||<|0.0001||||||Confirmatory testing will be performed in a hierarchical ordering: First analysis will be performed on the per protocol dataset, and if the corresponding p-value is below 0.025, the analysis will be performed on the full analysis dataset.|Farrington-Manning test|||||||<0.0001
72504795|NCT03114969|144540512|SUPERIORITY||Odds Ratio (OR)|3.196||||0.175|TWO_SIDED|95.0|0.596|17.14||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta+\[Relvar Ellipta+LAMA\] as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.|||17.140|0.596|0.175
72448232|NCT04719832|144413741|SUPERIORITY|Analysis performed using a negative binomial model with covariates of treatment, exacerbation history (2, 3, 4+), baseline inhaled CS dose (medium, high), geographical region, baseline percent predicted Forced Expiratory Volume in one second (FEV1), and offset of log (total time in the study in years).|Rate Ratio|0.42|||<|0.001|TWO_SIDED|95.0|0.3|0.59|||Negative binomial distribution|||To demonstrate the superiority of GSK3511294 100 mg SC + SoC following two doses (at Week 0 and at Week 26) compared with placebo + SoC, assessed by the annualized rate of clinically significant exacerbations measured over the study intervention period of 52 weeks.||0.59|0.30|< 0.001
72448233|NCT04719832|144413742|SUPERIORITY||Difference in Least Square Means|-3.36|||=|0.08|TWO_SIDED|95.0|-7.11|0.39|||Mixed Models Repeated Measures (MMRM)|||Analysis performed using a repeated measures model with covariates of treatment group, baseline ICS dose (medium or high), exacerbation history (2, 3, 4+), geographical region, baseline SGRQ total score, baseline pre-bronchodilator percent predicted FEV1, visit, visit by baseline SGRQ total score and visit by treatment group||0.39|-7.11|= 0.080
72448234|NCT04719832|144413743|SUPERIORITY||Difference in Least Square Means|-0.04|||=|0.69|TWO_SIDED|95.0|-0.27|0.18|||Mixed Models Repeated Measures (MMRM)|||Analysis performed using a repeated measures model with covariates of treatment group, baseline ICS dose (medium or high), exacerbation history (2, 3, 4+), geographical region, baseline ACQ-5 score, baseline pre-bronchodilator percent predicted FEV1, visit, visit by baseline ACQ-5 score and visit by treatment group.||0.18|-0.27|= 0.690
72448235|NCT04719832|144413744|SUPERIORITY||Difference in Least Square Means|-0.001|||=|0.991|TWO_SIDED|95.0|-0.089|0.088|||Mixed Models Repeated Measures (MMRM)|||Analysis performed using a repeated measures model with covariates of treatment group, baseline ICS dose (medium or high), exacerbation history (2, 3, 4+), geographical region, baseline pre-bronchodilator FEV1, visit, visit by baseline pre-bronchodilator FEV1 and visit by treatment group.||0.088|-0.089|= 0.991
72448236|NCT04719832|144413745|SUPERIORITY||Difference in Least Square Means|-0.09|||=|0.65|TWO_SIDED|95.0|-0.5|0.31|||Mixed Models Repeated Measures (MMRM)|||Analysis performed using a repeated measures model with covariates of treatment group, baseline ICS dose (medium or high), exacerbation history (2, 3, 4+), geographical region, baseline ANSD weekly mean score, baseline pre-bronchodilator percent predicted FEV1, visit, visit by baseline ANSD weekly mean score and visit by treatment group.||0.31|-0.50|= 0.650
72448237|NCT04719832|144413746|SUPERIORITY||Difference in Least Square Means|-0.08|||=|0.647|TWO_SIDED|95.0|-0.42|0.26|||Mixed Models Repeated Measures (MMRM)|||Analysis performed using a repeated measures model with covariates of treatment group, baseline ICS dose (medium or high), exacerbation history (2, 3, 4+), geographical region, baseline ADSD weekly mean score, baseline pre-bronchodilator percent predicted FEV1, visit, visit by baseline ADSD weekly mean score and visit by treatment group.||0.26|-0.42|= 0.647
72561537|NCT02250651|144653729|NON_INFERIORITY|MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.|Least-squares Mean Difference|-0.36|STANDARD_ERROR_OF_MEAN|0.39||0.3621|TWO_SIDED|95.0|-1.12|0.41|||MMRM|||Change from Baseline at Week 12, Hour 2: The hypothesis was that bimatoprost SR 10 μg was to be declared non-inferior to timolol 0.5% if the upper limit of the 95% CI was ≤ 1.5 mmHg for all scheduled timepoints (Hours 0 and 2 at Week 12).||0.41|-1.12|0.3621
72561538|NCT02250651|144653730|NON_INFERIORITY|MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.|Least-squares Mean Difference|-0.76|STANDARD_ERROR_OF_MEAN|0.36||0.0382||95.0|-1.48|-0.04|||MMRM|||Week 2, Hour 0: The hypothesis was that bimatoprost SR 15 μg was to be declared non-inferior to timolol 0.5% if the upper limit of the 95% CI was ≤ 1.5 mmHg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).||-0.04|-1.48|0.0382
72561539|NCT02250651|144653730|NON_INFERIORITY|MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.|Least-squares Mean Difference|-0.58|STANDARD_ERROR_OF_MEAN|0.36||0.1133||95.0|-1.29|0.14|||MMRM|||Week 2, Hour 0: The hypothesis was that bimatoprost SR 10 μg was to be declared non-inferior to timolol 0.5% if the upper limit of the 95% CI was ≤ 1.5 mmHg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).||0.14|-1.29|0.1133
72561540|NCT02250651|144653731|NON_INFERIORITY|MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.|Least-squares Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|0.34||0.0013||95.0|-1.76|-0.43|||MMRM|||Week 2, Hour 2: The hypothesis was that bimatoprost SR 15 μg was to be declared non-inferior to timolol 0.5% if the upper limit of the 95% CI was ≤ 1.5 mmHg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).||-0.43|-1.76|0.0013
72561541|NCT02250651|144653731|NON_INFERIORITY|MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.|Least-squares Mean Difference|-0.71|STANDARD_ERROR_OF_MEAN|0.34||0.0364||95.0|-1.38|-0.05|||MMRM|||Week 2, Hour 2: The hypothesis was that bimatoprost SR 10 μg was to be declared non-inferior to timolol 0.5% if the upper limit of the 95% CI was ≤ 1.5 mmHg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).||-0.05|-1.38|0.0364
72561542|NCT02250651|144653732|NON_INFERIORITY|MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.|Least-squares Mean Difference|-0.46|STANDARD_ERROR_OF_MEAN|0.38||0.2304||95.0|-1.22|0.29|||MMRM|||Week 6, Hour 0: The hypothesis was that bimatoprost SR 15 μg was to be declared non-inferior to timolol 0.5% if the upper limit of the 95% CI was ≤ 1.5 mmHg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).||0.29|-1.22|0.2304
72561543|NCT02250651|144653732|NON_INFERIORITY|MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.|Least-squares Mean Difference|-0.59|STANDARD_ERROR_OF_MEAN|0.38||0.1272||95.0|-1.34|0.17|||MMRM|||Week 6, Hour 0: The hypothesis was that bimatoprost SR 10 μg was to be declared non-inferior to timolol 0.5% if the upper limit of the 95% CI was ≤ 1.5 mmHg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).||0.17|-1.34|0.1272
72561544|NCT02250651|144653733|NON_INFERIORITY|MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.|Least-squares Mean Difference|-1.05|STANDARD_ERROR_OF_MEAN|0.36||0.0038||95.0|-1.76|-0.34|||MMRM|||Week 6, Hour 2: The hypothesis was that bimatoprost SR 15 μg was to be declared non-inferior to timolol 0.5% if the upper limit of the 95% CI was ≤ 1.5 mmHg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).||-0.34|-1.76|0.0038
72448238|NCT05228457|144413748|SUPERIORITY|13 participants were randomized to receive active TMS, and 13 were randomized to receive sham TMS. 1 participant from each group withdrew, resulting in their exclusion from the analysis. Therefore, 24 participants were randomized to active (n = 12) or sham (n = 12) aiTBS groups. The analysis examined MADRS scores measured at baseline and post-treatment. A priori hypotheses were that active aiTBS would demonstrate measurable differences in MADRS scores compared to the sham group.|Mean Difference (Final Values)|-14.8|||<|0.001|TWO_SIDED|95.0|-19.94|-9.56|||t-test, 2 sided||The primary outcome was the between-group (Active vs Sham) difference in MADRS scores at the end of the treatment period. Results, including mean scores, standard deviations, confidence intervals, and p-value for the between-group comparisons.|||-9.56|-19.94|<0.001
72448239|NCT05228457|144413749|SUPERIORITY||Z-transformed Pearson's r values|-0.014||||0.04|TWO_SIDED||||||t-test, 2 sided|||Z-transformed Pearson's r values of average voxel-wise connectivity within the DMN||||0.04
72448240|NCT04898673|144413762|SUPERIORITY||Mean Difference (Final Values)|-5.23|STANDARD_ERROR_OF_MEAN|0.41|<|0.001|TWO_SIDED|95.0|-6.08|-4.37|||ANOVA|||||-4.37|-6.08|<0.001
72448241|NCT04898673|144413763|SUPERIORITY||Mean Difference (Final Values)|0.6|STANDARD_ERROR_OF_MEAN|1.39||0.67|TWO_SIDED|95.0|-2.31|3.51|||ANOVA|||||3.51|-2.31|0.670
72448242|NCT04898673|144413764|NON_INFERIORITY|Non-inferiority margin=-10% words correct; CP1110 non-inferior to CP1000 if the lower limit of the confidence interval for the difference \> -10% words correct.|Mean Difference (Final Values)|-3.75|STANDARD_ERROR_OF_MEAN|1.55||0.026|TWO_SIDED|95.0|-7.0|-0.5|||ANOVA|||||-0.50|-7.00|0.026
72561545|NCT02250651|144653733|NON_INFERIORITY|MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.|Least-squares Mean Difference|-0.65|STANDARD_ERROR_OF_MEAN|0.36||0.0741||95.0|-1.36|0.06|||MMRM|||Week 6, Hour 2: The hypothesis was that bimatoprost SR 10 μg was to be declared non-inferior to timolol 0.5% if the upper limit of the 95% CI was ≤ 1.5 mmHg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).||0.06|-1.36|0.0741
72561546|NCT02250651|144653734|NON_INFERIORITY|MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.|Least-squares Mean Difference|-0.36|STANDARD_ERROR_OF_MEAN|0.41||0.3738||95.0|-1.17|0.44|||MMRM|||Week 12, Hour 0: The hypothesis was that bimatoprost SR 15 μg was to be declared non-inferior to timolol 0.5% if the upper limit of the 95% CI was ≤ 1.5 mmHg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).||0.44|-1.17|0.3738
72561547|NCT02250651|144653734|NON_INFERIORITY|MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.|Least-squares Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.41||0.8514||95.0|-0.88|0.73|||MMRM|||Week 12, Hour 0: The hypothesis was that bimatoprost SR 10 μg was to be declared non-inferior to timolol 0.5% if the upper limit of the 95% CI was ≤ 1.5 mmHg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).||0.73|-0.88|0.8514
72619464|NCT01557244|144769898|SUPERIORITY|||||||0.0327|||||||ANCOVA|||P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline bladder volume at first IDC and baseline weight.||||0.0327
72448243|NCT04898673|144413765|NON_INFERIORITY|Non-inferiority margin=-10% words correct; CP1110 non-inferior to CP1000 if the lower limit of the confidence interval for the difference \> -10% words correct.|Mean Difference (Final Values)|-1.15|STANDARD_ERROR_OF_MEAN|1.37||0.411|TWO_SIDED|95.0|-4.02|1.72|||ANOVA|||||1.72|-4.02|0.411
72448244|NCT01152450|144413777|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.149|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001||95.0|0.102|0.196|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R2.5 bid - Placebo|||0.196|0.102|<0.0001
72448245|NCT01152450|144413777|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.158|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001||95.0|0.111|0.205|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R5 qd - Placebo|||0.205|0.111|<0.0001
72448246|NCT01152450|144413777|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.009|STANDARD_ERROR_OF_MEAN|0.024||||95.0|-0.038|0.056|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R5 qd - Tio R2.5 bid|||0.056|-0.038|
72448247|NCT01152450|144413778|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|21.328|STANDARD_ERROR_OF_MEAN|5.19|<|0.0001||95.0|11.084|31.573|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R2.5 bid - Placebo|||31.573|11.084|<0.0001
72448248|NCT01152450|144413778|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|22.357|STANDARD_ERROR_OF_MEAN|5.225|<|0.0001||95.0|12.044|32.67|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R5 qd - Placebo|||32.670|12.044|<0.0001
72448249|NCT01152450|144413778|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.029|STANDARD_ERROR_OF_MEAN|5.242||||95.0|-9.318|11.376|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R5 qd - Tio R2.5 bid|||11.376|-9.318|
72619465|NCT01557244|144769898|SUPERIORITY|||||||0.0017|||||||ANCOVA|||P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline bladder volume at first IDC and baseline weight.||||0.0017
72448250|NCT01152450|144413779|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|29.92|STANDARD_ERROR_OF_MEAN|5.026|<|0.0001||95.0|20.001|39.839|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R2.5 bid - Placebo|||39.839|20.001|<0.0001
72448251|NCT01152450|144413779|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|28.657|STANDARD_ERROR_OF_MEAN|5.042|<|0.0001||95.0|18.707|38.606|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R5 qd - Placebo|||38.606|18.707|<0.0001
72448252|NCT01152450|144413779|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.264|STANDARD_ERROR_OF_MEAN|5.056||||95.0|-11.243|8.716|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R5 qd - Tio R2.5 bid|||8.716|-11.243|
72448253|NCT01152450|144413780|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.169|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001||95.0|0.12|0.218|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R2.5 bid - Placebo|||0.218|0.120|<0.0001
72448254|NCT01152450|144413780|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.185|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001||95.0|0.136|0.234|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R5 qd - Placebo|||0.234|0.136|<0.0001
72448255|NCT01152450|144413780|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.016|STANDARD_ERROR_OF_MEAN|0.025||||95.0|-0.033|0.065|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R5 qd - Tio R2.5 bid|||0.065|-0.033|
72448256|NCT01152450|144413781|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.129|STANDARD_ERROR_OF_MEAN|0.026|<|0.0001||95.0|0.077|0.181|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R2.5 bid - Placebo|||0.181|0.077|<0.0001
72448257|NCT01152450|144413781|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.131|STANDARD_ERROR_OF_MEAN|0.026|<|0.0001||95.0|0.079|0.183|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R5 qd - Placebo|||0.183|0.079|<0.0001
72448258|NCT01152450|144413781|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.002|STANDARD_ERROR_OF_MEAN|0.026||||95.0|-0.05|0.054|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R5 qd - Tio R2.5 bid|||0.054|-0.050|
72448259|NCT01152450|144413782|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.132|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001||95.0|0.084|0.179|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R2.5 bid - Placebo|||0.179|0.084|<0.0001
72448260|NCT01152450|144413782|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.131|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001||95.0|0.084|0.179|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R5 qd - Placebo|||0.179|0.084|<0.0001
72448261|NCT01152450|144413782|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.024||||95.0|-0.048|0.047|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R5 qd - Tio R2.5 bid|||0.047|-0.048|
72448262|NCT01152450|144413783|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.111|STANDARD_ERROR_OF_MEAN|0.03||0.0002||95.0|0.053|0.17|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R2.5 bid - Placebo|||0.170|0.053|0.0002
72448263|NCT01152450|144413783|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.133|STANDARD_ERROR_OF_MEAN|0.029|<|0.0001||95.0|0.074|0.191|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R5 qd - Placebo|||0.191|0.074|<0.0001
72448264|NCT01152450|144413783|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.021|STANDARD_ERROR_OF_MEAN|0.03||||95.0|-0.037|0.08|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R5 qd - Tio R2.5 bid|||0.080|-0.037|
72448265|NCT01152450|144413784|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.068|STANDARD_ERROR_OF_MEAN|0.035||0.0515||95.0|0.0|0.136|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R2.5 bid - Placebo|||0.136|0.000|0.0515
72448266|NCT01152450|144413784|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.056|STANDARD_ERROR_OF_MEAN|0.035||0.1058||95.0|-0.012|0.124|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R5 qd - Placebo|||0.124|-0.012|0.1058
72448267|NCT01152450|144413784|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.012|STANDARD_ERROR_OF_MEAN|0.035||||95.0|-0.08|0.057|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R5 qd - Tio R2.5 bid|||0.057|-0.080|
72448268|NCT01152450|144413785|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.125|STANDARD_ERROR_OF_MEAN|0.026|<|0.0001||95.0|0.073|0.177|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R2.5 bid - Placebo|||0.177|0.073|<0.0001
72448269|NCT01152450|144413785|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.026||0.0002||95.0|0.048|0.152|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R5 qd - Placebo|||0.152|0.048|0.0002
72448270|NCT01152450|144413785|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.025|STANDARD_ERROR_OF_MEAN|0.026||||95.0|-0.077|0.027|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R5 qd - Tio R2.5 bid|||0.027|-0.077|
72448271|NCT01152450|144413786|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.076|STANDARD_ERROR_OF_MEAN|0.027||0.0051||95.0|0.023|0.129|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R2.5 bid - Placebo|||0.129|0.023|0.0051
72448272|NCT01152450|144413786|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.068|STANDARD_ERROR_OF_MEAN|0.027||0.0123||95.0|0.015|0.12|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R5 qd - Placebo|||0.120|0.015|0.0123
72448273|NCT01152450|144413786|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.008|STANDARD_ERROR_OF_MEAN|0.027||||95.0|-0.061|0.045|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R5 qd - Tio R2.5 bid|||0.045|-0.061|
72619466|NCT01557244|144769898|OTHER||Difference in LS Mean|-10.78|||||TWO_SIDED|95.0|-48.75|27.19||||||||27.19|-48.75|
72619467|NCT01557244|144769898|OTHER||Difference in LS Mean|-15.25|||||TWO_SIDED|95.0|-50.15|19.64||||||||19.64|-50.15|
72619468|NCT01557244|144769899|SUPERIORITY|||||||0.0679|||||||ANCOVA|||P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline bladder compliance and baseline weight.||||0.0679
72390556|NCT01203098|144288862|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|-1.3|||||TWO_SIDED|95.0|-7.2|4.6||||||Primary analyses were performed on proportion of subjects who experienced thromboembolic events defined as primary efficacy endpoint (incidence of thromboembolic events); incidence of thromboembolic events and its 95% confidence interval (CI) were calculated by treatment group, and difference between DU-176b 15 mg and 30 mg groups and its 95% CI were also calculated. For reference, difference between enoxaparin group and each DU-176b group and its 95% CI of each were calculated.||4.6|-7.2|
72390557|NCT01203098|144288862|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.1|||||TWO_SIDED|95.0|-4.6|6.8||||||Primary analyses were performed on proportion of subjects who experienced thromboembolic events defined as primary efficacy endpoint (incidence of thromboembolic events); incidence of thromboembolic events and its 95% confidence interval (CI) were calculated by treatment group, and difference between DU-176b 15 mg and 30 mg groups and its 95% CI were also calculated. For reference, difference between enoxaparin group and each DU-176b group and its 95% CI of each were calculated.||6.8|-4.6|
72390558|NCT00730405|144288867|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
72390559|NCT00730405|144288867|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
72390560|NCT00730405|144288867|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
72390561|NCT00730405|144288867|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
72390562|NCT00730405|144288868|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
72390563|NCT00730405|144288868|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
72390564|NCT00730405|144288868|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
72390565|NCT00730405|144288868|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
72390566|NCT00730405|144288869|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
72390567|NCT00730405|144288869|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
72390568|NCT00730405|144288869|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
72390569|NCT00730405|144288869|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
72390570|NCT00730405|144288870|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
72390571|NCT00730405|144288870|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
72390572|NCT00730405|144288870|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
72390573|NCT00730405|144288870|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
72390574|NCT00730405|144288871|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-6.1|STANDARD_ERROR_OF_MEAN|0.57|<|0.001|||||||ANOVA|||||||<0.001
72390575|NCT00730405|144288871|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.71|STANDARD_ERROR_OF_MEAN|0.57|<|0.001|||||||ANOVA|||||||<0.001
72390576|NCT00730405|144288871|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.44|STANDARD_ERROR_OF_MEAN|0.57|<|0.001|||||||ANOVA|||||||<0.001
72390577|NCT00730405|144288871|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.22|STANDARD_ERROR_OF_MEAN|0.58|<|0.001|||||||ANOVA|||||||<0.001
72390578|NCT00730405|144288872|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
72390579|NCT00730405|144288872|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
72390580|NCT00730405|144288872|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
72390581|NCT00730405|144288872|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
72390582|NCT00959764|144288883|NON_INFERIORITY_OR_EQUIVALENCE|"Assumed placebo-adjusted effect for both active treatment groups (% increase in BMD)was 1.56% and that the placebo adjusted effect for the rsCT tablets must be at least 0.5 times the placebo adjusted effect for the calcitonin nasal spray (active control treatment group). The null hypothesis to be tested was:~\[Mean(oral) - Mean(placebo)\] - 0.5 x \[Mean(nasal) - Mean(placebo)\] \< 0. Reference Pigeot, et al. 2003"|Mean Difference (Net)|0.77|STANDARD_DEVIATION|2.5||0.002|TWO_SIDED|95.0|0.08|1.45||The P-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was \<0.05|ANCOVA|||The overall analysis across groups was an Analysis of Covariance where the study was powered to 80% with an assumption of a standard deviation of 2.5% and a two-sided 5% level of significance. For each treatment group, the BMD at 48 weeks was compared with the BMD at baseline and a % increase was calculated (baseline = 0%). This difference was subjected to the t-test. Two-sided P-value is less than or equal to 0.05 and was not adjusted as multiple comparisons were not done.||1.45|0.08|0.002
72390583|NCT00959764|144288884|NON_INFERIORITY_OR_EQUIVALENCE|Same as for Primary Outcome|Mean Difference (Net)|-21.84|STANDARD_DEVIATION|41.99||0.0006||||||P-value not adjusted for multiple comparisons; a priori threshold for significance was 0.05|ANCOVA|95% confidence interval not calculated||Same as for Primary Outcome||||0.0006
72390584|NCT00959764|144288885|NON_INFERIORITY_OR_EQUIVALENCE|Same as Primary Outcome|Mean Difference (Net)|-18.09|STANDARD_DEVIATION|47.53||0.0012||||||p-value not adjusted for multiple comparisons; a priori threshold for statistical significance was set at 0.05.|ANCOVA||oral calcitonin vs placebo|Same as Primary Outcome||||0.0012
72390585|NCT02002091|144288891|OTHER|||||||0.706|||||||Chi-squared|||||||0.706
72390586|NCT02002091|144288892|OTHER|||||||0.346|||||||Chi-squared|||||||0.346
72390587|NCT02002091|144288893|OTHER|||||||0.123|||||||Mantel Haenszel|||||||0.123
72390588|NCT02002091|144288894|OTHER|||||||0.968|||||||Chi-squared, Corrected|||||||0.968
72390589|NCT02002091|144288895|SUPERIORITY_OR_OTHER_LEGACY|||||||0.004||||||The threshold for statistical significance for P-Value is \<0.05|Fisher Exact|||||||0.004
72390590|NCT02002091|144288896|SUPERIORITY_OR_OTHER_LEGACY|||||||0.988|||||||Fisher Exact|||||||0.988
72390591|NCT02002091|144288897|SUPERIORITY_OR_OTHER_LEGACY|||||||0.038|||||||Fisher Exact|||||||0.038
72390592|NCT02002091|144288899|SUPERIORITY_OR_OTHER_LEGACY|||||||0.917|||||||Chi-squared, Corrected|||||||0.917
72390593|NCT02002091|144288900|SUPERIORITY_OR_OTHER_LEGACY|||||||0.816|||||||Chi-squared, Corrected|||||||0.816
72390594|NCT02002091|144288901|SUPERIORITY_OR_OTHER_LEGACY|||||||0.008||||||Statistical significance : p\< 0.05|Fisher Exact|||||||0.008
72390595|NCT02002091|144288903|OTHER|||||||0.025||||||The threshold of statistical difference is P-value \< 0.05|Chi-squared, Corrected|||||||0.025
72390596|NCT02002091|144288906|OTHER|||||||0.059||||||the threshold for statistical significance used is P-value \<0.05|Fisher Exact|||||||0.059
72390597|NCT03087643|144288922|OTHER|||||||0.0492|||||||Mixed Models Analysis|||||||0.0492
72390598|NCT03087643|144288923|OTHER|||||||0.0283|||||||Mixed Models Analysis|||||||0.0283
72498439|NCT03051633|144527438|SUPERIORITY|Event: dichotimized self-reported first-time alcohol intoxication in known participant history prior to data collection, where intoxication was not reported in prior measurement occasions. Episodes: Represent the period of time between measurement occasions, thus, each episode represents the measured period of time between each assessment wave. Censoring: Indicates the risk period during which particpants experienced intoxication uptake.|Hazard Ratio, log|-0.39||||0.037|TWO_SIDED|95.0|-0.762|-0.018|||Regression, Logistic|Discrete time hazard model represents a survival analysis, with the outcome parameters reflecting a hazard ration rather than odds.||Discrete time hazard represents the conditional probability that a student will experience first time alcohol initiation during a given measurement period, given that students did not become intoxicated in a previous measurement period. Thus, for each model, we tested the following hypothesis: controlling for age at first assessment, students attending BUYOI-assigned schools will have a lower risk of substance use uptake at the end of their eight grade year||-0.018|-0.762|.037
72498440|NCT03051633|144527439|SUPERIORITY|Event: Dichotimized self-reported first-time marijuana use in known participant history prior to data-collection, where marijuana use was not previously reported in prior measurement occasions of this four-wave longitudinal study. Episodes: Episodes represent the period of time between measurement occasions, as such, each episode represents the measured period of time between each wave of assessments. Censoring: If marijuana use was reported, censoring indicator indicates the risk period.|Hazard Ratio, log|0.17||||0.228|TWO_SIDED|95.0|-0.104|0.444|||Regression, Logistic|Discrete time hazard model represents a survival analysis, with the outcome parameters reflecting a hazard ratio rather than odds.||Discrete time hazard represents the conditional probability that a student will experience first time marijuana use during a given measurement period, given that students did not use marijuana in a previous measurement period. Thus for each model, we tested the following hypothesis: Controlling for age at first-assessment, students attending BUYOI-assigned schools will have a lower risk of marijuana use uptake by the end of their eighth-grade year, relative to students attending control schools.||0.444|-0.104|0.228
72498441|NCT03575104|144527451|OTHER|The Type I error rate was controlled for the testing of multiple null hypotheses associated with the endpoint assessed at 1 and 3 months of treatment and the two dose levels studied. Each null hypothesis was tested against the alternative hypothesis that daridorexant improved the endpoint at the given dose and time point compared to placebo. The order of testing and the alpha level applied to each null hypothesis was based on the Bonferroni-based gatekeeping procedure (see SAP for details).|LS mean difference to placebo|-11.62||||0.0001|TWO_SIDED|95.0|-17.604|-5.633||Mixed effects model for repeated measures: change from baseline in WASO = baseline WASO + age group (\< 65; ≥ 65 years) + treatment + visit + treatment × visit + baseline × visit.|Mixed Models Analysis|Hypothesis testing result: threshold for significance p = 0.025; statistically significant = YES||Between-treatment analysis for change from baseline in WASO (min) to Month 1 (Daridorexant 25 mg vs placebo).||-5.633|-17.604|0.0001
72498442|NCT03575104|144527451|OTHER|The Type I error rate was controlled for the testing of multiple null hypotheses associated with the endpoint assessed at 1 and 3 months of treatment and the two dose levels studied. Each null hypothesis was tested against the alternative hypothesis that daridorexant improved the endpoint at the given dose and time point compared to placebo. The order of testing and the alpha level applied to each null hypothesis was based on the Bonferroni-based gatekeeping procedure (see SAP for details).|LS mean difference to placebo|-2.74||||0.3669|TWO_SIDED|95.0|-8.693|3.215||Mixed effects model for repeated measures: change from baseline in WASO = baseline WASO + age group (\< 65; ≥ 65 years) + treatment + visit + treatment × visit + baseline × visit.|Mixed Models Analysis|Hypothesis testing result: threshold for significance p = 0.00977; statistically significant = NO||Between-treatment analysis for change from baseline in WASO (min) to Month 1 (Daridorexant 10 mg vs placebo).||3.215|-8.693|0.3669
72498443|NCT03575104|144527452|OTHER|The Type I error rate was controlled for the testing of multiple null hypotheses associated with the endpoint assessed at 1 and 3 months of treatment and the two dose levels studied. Each null hypothesis was tested against the alternative hypothesis that daridorexant improved the endpoint at the given dose and time point compared to placebo. The order of testing and the alpha level applied to each null hypothesis was based on the Bonferroni-based gatekeeping procedure (see SAP for details).|LS Mean difference to placebo|-10.25||||0.0028|TWO_SIDED|95.0|-16.95|-3.548||Mixed effects model for repeated measures: change from baseline in WASO = baseline WASO + age group (\< 65; ≥ 65 years) + treatment + visit + treatment × visit + baseline × visit.|Mixed Models Analysis|Hypothesis testing result: threshold for significance p = 0.01563; statistically significant = YES||Between-treatment analysis for change from baseline in WASO (min) to Month 3 (Daridorexant 25 mg vs placebo).||-3.548|-16.95|0.0028
72498444|NCT03575104|144527452|OTHER|The Type I error rate was controlled for the testing of multiple null hypotheses associated with the endpoint assessed at 1 and 3 months of treatment and the two dose levels studied. Each null hypothesis was tested against the alternative hypothesis that daridorexant improved the endpoint at the given dose and time point compared to placebo. The order of testing and the alpha level applied to each null hypothesis was based on the Bonferroni-based gatekeeping procedure (see SAP for details).|LS Mean difference to placebo|-1.95||||0.5686|TWO_SIDED|95.0|-8.666|4.764||Mixed effects model for repeated measures: change from baseline in WASO = baseline WASO + age group (\< 65; ≥ 65 years) + treatment + visit + treatment × visit + baseline × visit.|Mixed Models Analysis|Hypothesis testing result: threshold for significance p = 0; statistically significant = NO||Between-treatment analysis for change from baseline in WASO (min) to Month 3 (Daridorexant 10 mg vs placebo).||4.764|-8.666|0.5686
72619469|NCT01557244|144769899|SUPERIORITY|||||||0.1233|||||||ANCOVA|||P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline bladder compliance and baseline weight.||||0.1233
72390599|NCT03087643|144288924|OTHER|||||||0.0321|||||||Mixed Models Analysis|||||||0.0321
72390600|NCT03087643|144288925|OTHER|||||||0.0451|||||||Mixed Models Analysis|||||||0.0451
72390601|NCT03087643|144288926|OTHER|||||||0.0476|||||||Mixed Models Analysis|||||||0.0476
72390602|NCT00113022|144288928|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.22|STANDARD_ERROR_OF_MEAN|18.867||0.919|TWO_SIDED|95.0|-46.565|51.006||The test reported here examines the main effect for placebo versus drug.|Mixed Models Analysis||A positive value indicates greater depression in the active treatment group compared to placebo.|Per protocol, a linear mixed model with a first order autoregressive covariance structure was used. Baseline was included as a covariate. Drug and visit were main effects with an interaction between them included.||51.006|-46.565|.919
72448274|NCT01152450|144413787|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.077|STANDARD_ERROR_OF_MEAN|0.027||0.0042||95.0|0.025|0.13|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R2.5 bid - Placebo|||0.130|0.025|0.0042
72448275|NCT01152450|144413787|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.048|STANDARD_ERROR_OF_MEAN|0.027||0.0747||95.0|-0.005|0.1|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R5 qd - Placebo|||0.100|-0.005|0.0747
72448276|NCT01152450|144413787|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.029|STANDARD_ERROR_OF_MEAN|0.027||||95.0|-0.082|0.023|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R5 qd - Tio R2.5 bid|||0.023|-0.082|
72448277|NCT01152450|144413791|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.101|STANDARD_ERROR_OF_MEAN|0.023|<|0.0001||95.0|0.055|0.147|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R2.5 bid - Placebo|||0.147|0.055|<0.0001
72448278|NCT01152450|144413791|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.084|STANDARD_ERROR_OF_MEAN|0.023||0.0004||95.0|0.038|0.13|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R5 qd - Placebo|||0.130|0.038|0.0004
72448279|NCT01152450|144413791|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.016|STANDARD_ERROR_OF_MEAN|0.023||||95.0|-0.063|0.03|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R5 qd - Tio R2.5 bid|||0.030|-0.063|
72448280|NCT01152450|144413792|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|30.242|STANDARD_ERROR_OF_MEAN|4.091|<|0.0001||95.0|22.167|38.317|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R2.5 bid - Placebo|||38.317|22.167|<0.0001
72448281|NCT01152450|144413792|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|34.31|STANDARD_ERROR_OF_MEAN|4.089|<|0.0001||95.0|26.24|42.38|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R5 qd - Placebo|||42.380|26.240|<0.0001
72448282|NCT01152450|144413792|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.068|STANDARD_ERROR_OF_MEAN|4.094||||95.0|-4.012|12.148|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R5 qd - Tio R2.5 bid|||12.148|-4.012|
72448283|NCT01152450|144413793|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.323|STANDARD_ERROR_OF_MEAN|0.769||0.6747||95.0|-1.195|1.841|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R2.5 bid - Placebo|||1.841|-1.195|0.6747
72448284|NCT01152450|144413793|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.389|STANDARD_ERROR_OF_MEAN|0.774||0.6159||95.0|-1.138|1.916|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R5 qd - Placebo|||1.916|-1.138|0.6159
72448285|NCT01152450|144413793|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.065|STANDARD_ERROR_OF_MEAN|0.777||||95.0|-1.468|1.599|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R5 qd - Tio R2.5 bid|||1.599|-1.468|
72448286|NCT01152450|144413794|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.077|STANDARD_ERROR_OF_MEAN|0.142||0.5906||95.0|-0.358|0.204|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R2.5 bid - Placebo|||0.204|-0.358|0.5906
72448287|NCT01152450|144413794|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.176|STANDARD_ERROR_OF_MEAN|0.143||0.2208||95.0|-0.458|0.106|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R5 qd - Placebo|||0.106|-0.458|0.2208
72448288|NCT01152450|144413794|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.099|STANDARD_ERROR_OF_MEAN|0.143||||95.0|-0.382|0.184|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R5 qd - Tio R2.5 bid|||0.184|-0.382|
72448289|NCT01152450|144413795|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.002|STANDARD_ERROR_OF_MEAN|0.082||0.9797||95.0|-0.163|0.159|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R2.5 bid - Placebo|||0.159|-0.163|0.9797
72619470|NCT01557244|144769899|SUPERIORITY|||||||0.0019|||||||ANCOVA|||P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline bladder compliance and baseline weight.||||0.0019
72448290|NCT01152450|144413795|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.062|STANDARD_ERROR_OF_MEAN|0.082||0.4518||95.0|-0.223|0.1|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R5 qd - Placebo|||0.100|-0.223|0.4518
72448291|NCT01152450|144413795|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.06|STANDARD_ERROR_OF_MEAN|0.082||||95.0|-0.222|0.102|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R5 qd - Tio R2.5 bid|||0.102|-0.222|
72448292|NCT01152450|144413796|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.061|STANDARD_ERROR_OF_MEAN|0.074||0.4089||95.0|-0.207|0.085|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R2.5 bid - Placebo|||0.085|-0.207|0.4089
72448293|NCT01152450|144413796|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.074|STANDARD_ERROR_OF_MEAN|0.074||0.3185||95.0|-0.221|0.072|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R5 qd - Placebo|||0.072|-0.221|0.3185
72448294|NCT01152450|144413796|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.013|STANDARD_ERROR_OF_MEAN|0.074||||95.0|-0.16|0.134|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R5 qd - Tio R2.5 bid|||0.134|-0.160|
72448295|NCT01152450|144413797|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.001|STANDARD_ERROR_OF_MEAN|0.031||0.9626||95.0|-0.059|0.062|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R2.5 bid - Placebo|||0.062|-0.059|0.9626
72448296|NCT01152450|144413797|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.003|STANDARD_ERROR_OF_MEAN|0.031||0.9102||95.0|-0.058|0.065|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R5 qd - Placebo|||0.065|-0.058|0.9102
72448297|NCT01152450|144413797|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.002|STANDARD_ERROR_OF_MEAN|0.031||||95.0|-0.059|0.063|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R5 qd - Tio R2.5 bid|||0.063|-0.059|
72448298|NCT02606422|144413807|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|||||||<.05
72619471|NCT01557244|144769899|OTHER||Difference in LS Mean|-4.96|||||TWO_SIDED|95.0|-14.81|4.89||||||||4.89|-14.81|
72619472|NCT01557244|144769899|OTHER||Difference in LS Mean|-5.95|||||TWO_SIDED|95.0|-15.85|3.95||||||||3.95|-15.85|
72448299|NCT04625465|144413828|OTHER||Difference in the log odds ratios|0.042||||0.869|||||||Multilevel logistic regression|||"Multilevel logistic regression of daily IPV perpetration on alcohol use (Level 1) nested within participant (Level 2) with interaction between alcohol use and CBT Intervention.~Testing the difference in odds ratio between groups 1 (No Intervention and Attention Control ) and 2 (CBT Texts Intervention) H0: OR1 = OR2"||||.869
72448300|NCT04625465|144413829|OTHER||Difference in the log odds ratios|-0.32||||0.21|||||||Multilevel logistic regression|||"Multilevel logistic regression of daily IPV perpetration on alcohol use (Level 1) nested within participant (Level 2) with interaction between alcohol use and CBT Intervention.~Testing the difference in odds ratio between groups 1 (No Intervention and Attention Control ) and 2 (CBT Texts Intervention) H0: OR1 = OR2"||||.210
72448301|NCT05566639|144413836|NON_INFERIORITY|Noninferiority margin = 10%|Relative vaccine efficacy (rVE)|1.7||||0.1715|TWO_SIDED|95.0|-24.1|22.2|||Stratified Cox proportional hazards||rVE = 100 \* (1 - HR) % was defined as the percent reduction in the hazard (mRNA-1010 vs active comparator), where HR was the hazard ratio between mRNA-1010 vs the active comparator.|||22.2|-24.1|0.1715
72448302|NCT04731818|144413849|SUPERIORITY||Mean Difference (Final Values)|0.0001|||<|0.0001|TWO_SIDED|||||analyzed by 1-way repeated measures analysis of variance (ANOVA) with post hoc Tukey multiple comparison test|ANOVA|1 way repeated measures ANOVA||||||<0.0001
72448303|NCT04159415|144413867|SUPERIORITY||Least Squares (LS) Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|1.0|||TWO_SIDED|95.0|-1.8|2.4|||||Confidence interval (CI) based on treatment group difference (R4461 Low dose vs. placebo) of the LS means using mixed-effect model with repeated measures (MMRM) model|||2.4|-1.8|
72448304|NCT04159415|144413868|SUPERIORITY||LS Mean Difference|38.1|STANDARD_ERROR_OF_MEAN|27.3|||TWO_SIDED|95.0|-21.3|97.5|||||Confidence interval (CI) based on treatment group difference (R4461 Low dose vs. placebo) of the LS means using mixed-effect model with repeated measures (MMRM) model|||97.5|-21.3|
72448305|NCT04159415|144413869|SUPERIORITY||Adjusted Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|29.0|||TWO_SIDED|95.0|-56.9|56.9|||||Combined estimate for adjusted mean difference (SE) vs Placebo obtained by combining adjusted means and SE from ANCOVA model analyses of the different imputed data sets.|||56.9|-56.9|
72448306|NCT04159415|144413870|SUPERIORITY||Adjusted Mean Difference|17.8|STANDARD_ERROR_OF_MEAN|43.6|||TWO_SIDED|95.0|-67.6|103.2|||||Combined estimate for adjusted mean difference (SE) vs Placebo obtained by combining adjusted means and SE from robust regression model analyses of the different imputed data sets.|||103.2|-67.6|
72448307|NCT02696707|144413926|NON_INFERIORITY|The non-inferiority margin between groups was set as 4%|Difference|-0.6|||||TWO_SIDED|95.0|-2.5|1.2||||||||1.2|-2.5|
72448308|NCT05292872|144413933|SUPERIORITY||Hazard Ratio (HR)|0.37|||<|0.001|TWO_SIDED|95.0|0.143|0.752||1-sided p-values are proportion of bootstrap replicates exceeding null (defined as a HR of 1) in each direction), and the two-tailed p-value is twice the smaller of one-tailed p-values. A two-tailed p-value was calculated for HR using this method.|Nonparametric bootstrap approach|||||0.752|0.143|<.001
72448309|NCT05260112|144413937|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
72448310|NCT05260112|144413938|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
72448311|NCT05260112|144413939|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
72448312|NCT05260112|144413940|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
72448313|NCT05260112|144413941|OTHER|||||||0.53|||||||Wilcoxon (Mann-Whitney)|||||||0.53
72448314|NCT05260112|144413942|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
72448315|NCT03798093|144413985|SUPERIORITY||least squares|-0.112||||0.08|TWO_SIDED|95.0|-29.3|1.7|||Regression, Linear|||||1.7|-29.3|0.08
72448316|NCT04119843|144414078|SUPERIORITY|Reader success for the primary analysis was achieved if the reading results demonstrated superiority of combined MRI versus unenhanced MRI for both lesion border delineation and lesion contrast. The acceptance by two out of three readers was considered to be a successful demonstration of efficacy in the study.|Mean Difference (Final Values)|0.95|STANDARD_DEVIATION|0.824|<|0.001|TWO_SIDED|95.0|0.743|1.165|||t-test, 1 sided|p-values show a one-sided t-test with a significance level of 0.025.|Positive changes in lesion border delineation mean difference (combined MRI compared to unenhanced MRI) represents a better outcome.|Paired difference of combined MRI versus unenhanced MRI: Reader 1||1.165|0.743|<0.001
72448317|NCT04119843|144414078|SUPERIORITY|Reader success for the primary analysis was achieved if the reading results demonstrated superiority of combined MRI versus unenhanced MRI for both lesion border delineation and lesion contrast. The acceptance by two out of three readers was considered to be a successful demonstration of efficacy in the study.|Mean Difference (Final Values)|0.8|STANDARD_DEVIATION|0.892|<|0.001|TWO_SIDED|95.0|0.552|1.043|||t-test, 1 sided|p-values show a one-sided t-test with a significance level of 0.025.|Positive changes in lesion border delineation mean difference (combined MRI compared to unenhanced MRI) represents a better outcome.|Paired difference of combined MRI versus unenhanced MRI: Reader 2||1.043|0.552|<0.001
72448318|NCT04119843|144414078|SUPERIORITY|Reader success for the primary analysis was achieved if the reading results demonstrated superiority of combined MRI versus unenhanced MRI for both lesion border delineation and lesion contrast. The acceptance by two out of three readers was considered to be a successful demonstration of efficacy in the study.|Mean Difference (Final Values)|0.65|STANDARD_DEVIATION|0.622|<|0.001|TWO_SIDED|95.0|0.494|0.813|||t-test, 1 sided|p-values show a one-sided t-test with a significance level of 0.025.|Positive changes in lesion border delineation mean difference (combined MRI compared to unenhanced MRI) represents a better outcome.|Paired difference of combined MRI versus unenhanced MRI: Reader 3||0.813|0.494|<0.001
72448319|NCT04119843|144414079|SUPERIORITY|Reader success of the primary analysis was achieved if the reading results demonstrated superiority of combined MRI versus unenhanced MRI for both lesion border delineation and lesion contrast. The acceptance by two out of three readers was considered to be a successful demonstration of efficacy in the study.|Mean Difference (Final Values)|0.98|STANDARD_DEVIATION|0.853|<|0.001|TWO_SIDED|95.0|0.759|1.196|||t-test, 1 sided|p-values show a one-sided t-test with a significance level of 0.025.|Positive changes in lesion contrast mean difference (combined MRI compared to unenhanced MRI) represents a better outcome.|Paired difference of combined MRI versus unenhanced MRI: Reader 1||1.196|0.759|<0.001
72619473|NCT01557244|144769900|SUPERIORITY|||||||0.0116|||||||ANCOVA|||P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline number of micturitions per 24 hours and baseline weight.||||0.0116
72448320|NCT04119843|144414079|SUPERIORITY|Reader success of the primary analysis was achieved if the reading results demonstrated superiority of combined MRI versus unenhanced MRI for both lesion border delineation and lesion contrast. The acceptance by two out of three readers was considered to be a successful demonstration of efficacy in the study.|Mean Difference (Final Values)|1.02|STANDARD_DEVIATION|0.909|<|0.001|TWO_SIDED|95.0|0.766|1.267|||t-test, 1 sided|p-values show a one-sided t-test with a significance level of 0.025.|Positive changes in lesion contrast mean difference (combined MRI compared to unenhanced MRI) represents a better outcome.|Paired difference of combined MRI versus unenhanced MRI: Reader 2||1.267|0.766|<0.001
72448321|NCT04119843|144414079|SUPERIORITY|Reader success for the primary analysis was achieved if the reading results demonstrated superiority of combined MRI versus unenhanced MRI for both lesion border delineation and lesion contrast. The acceptance by two out of three readers was considered to be a successful demonstration of efficacy in the study.|Mean Difference (Final Values)|0.81|STANDARD_DEVIATION|0.678|<|0.001|TWO_SIDED|95.0|0.638|0.985|||t-test, 1 sided|p-values show a one-sided t-test with a significance level of 0.025.|Positive changes in lesion contrast mean difference (combined MRI compared to unenhanced MRI) represents a better outcome.|Paired difference of combined MRI versus unenhanced MRI: Reader 3||0.985|0.638|<0.001
72448322|NCT04119843|144414081|SUPERIORITY|Reader success was achieved if the reading results demonstrated superiority of mangoral-enhanced MRI versus unenhanced MRI for both lesion border delineation and lesion contrast. The acceptance by two out of three readers was considered to be a successful demonstration of efficacy in the study.|Mean Difference (Final Values)|0.76|STANDARD_DEVIATION|0.805|<|0.001|TWO_SIDED|95.0|0.555|0.971|||t-test, 1 sided|p-values show a one-sided t-test with a significance level of 0.025.|Positive changes in lesion border delineation mean difference (mangoral-enhanced MRI compared to unenhanced MRI) represents a better outcome.|Paired difference of mangoral-enhanced MRI versus unenhanced MRI: Reader 1||0.971|0.555|<0.001
72448323|NCT04119843|144414081|SUPERIORITY|Reader success was achieved if the reading results demonstrated superiority of mangoral-enhanced MRI versus unenhanced MRI for both lesion border delineation and lesion contrast. The acceptance by two out of three readers was considered to be a successful demonstration of efficacy in the study.|Mean Difference (Final Values)|0.76|STANDARD_DEVIATION|1.059|<|0.001|TWO_SIDED|95.0|0.464|1.054|||t-test, 1 sided|p-values show a one-sided t-test with a significance level of 0.025.|Positive changes in lesion border delineation mean difference (mangoral-enhanced MRI compared to unenhanced MRI) represents a better outcome.|Paired difference of mangoral-enhanced MRI versus unenhanced MRI: Reader 2||1.054|0.464|<0.001
72448324|NCT04119843|144414081|SUPERIORITY|Reader success was achieved if the reading results demonstrated superiority of mangoral-enhanced MRI versus unenhanced MRI for both lesion border delineation and lesion contrast. The acceptance by two out of three readers was considered to be a successful demonstration of efficacy in the study.|Mean Difference (Final Values)|0.59|STANDARD_DEVIATION|0.609|<|0.001|TWO_SIDED|95.0|0.429|0.747|||t-test, 1 sided|p-values show a one-sided t-test with a significance level of 0.025.|Positive changes in lesion border delineation mean difference (mangoral-enhanced MRI compared to unenhanced MRI) represents a better outcome.|Paired difference of mangoral-enhanced MRI versus unenhanced MRI: Reader 3||0.747|0.429|<0.001
72448325|NCT04119843|144414082|SUPERIORITY|Reader success was achieved if the reading results demonstrated superiority of mangoral-enhanced MRI versus unenhanced MRI for both lesion border delineation and lesion contrast. The acceptance by two out of three readers was considered to be a successful demonstration of efficacy in the study.|Mean Difference (Final Values)|0.95|STANDARD_DEVIATION|0.852|<|0.001|TWO_SIDED|95.0|0.726|1.166|||t-test, 1 sided|p-values show a one-sided t-test with a significance level of 0.025.|Positive changes in lesion contrast mean difference (mangoral-enhanced MRI compared to unenhanced MRI) represents a better outcome.|Paired difference of mangoral-enhanced MRI versus unenhanced MRI: Reader 1||1.166|0.726|<0.001
72448326|NCT04119843|144414082|SUPERIORITY|Reader success was achieved if the reading results demonstrated superiority of mangoral-enhanced MRI versus unenhanced MRI for both lesion border delineation and lesion contrast. The acceptance by two out of three readers was considered to be a successful demonstration of efficacy in the study.|Mean Difference (Final Values)|0.73|STANDARD_DEVIATION|1.261|<|0.001|TWO_SIDED|95.0|0.38|1.082|||t-test, 1 sided|p-values show a one-sided t-test with a significance level of 0.025.|Positive changes in lesion contrast mean difference (mangoral-enhanced MRI compared to unenhanced MRI) represents a better outcome.|Paired difference of mangoral-enhanced MRI versus unenhanced MRI: Reader 2||1.082|0.380|<0.001
72498445|NCT03575104|144527453|OTHER|The Type I error rate was controlled for the testing of multiple null hypotheses associated with the endpoint assessed at 1 and 3 months of treatment and the two dose levels studied. Each null hypothesis was tested against the alternative hypothesis that daridorexant improved the endpoint at the given dose and time point compared to placebo. The order of testing and the alpha level applied to each null hypothesis was based on the Bonferroni-based gatekeeping procedure (see SAP for details).|LS mean difference to placebo|-6.45||||0.0303|TWO_SIDED|95.0|-12.282|-0.614||Mixed effects model for repeated measures: change from baseline in LPS = baseline LPS + age group (\< 65; ≥ 65 years) + treatment + visit + treatment × visit + baseline × visit.|Mixed Models Analysis|Hypothesis testing result: threshold for significance p = 0.025; statistically significant = NO||Between-treatment analysis for change from baseline in LPS (min) to Month 1 (Daridorexant 25 mg vs placebo).||-0.614|-12.282|0.0303
72498446|NCT03575104|144527453|OTHER|The Type I error rate was controlled for the testing of multiple null hypotheses associated with the endpoint assessed at 1 and 3 months of treatment and the two dose levels studied. Each null hypothesis was tested against the alternative hypothesis that daridorexant improved the endpoint at the given dose and time point compared to placebo. The order of testing and the alpha level applied to each null hypothesis was based on the Bonferroni-based gatekeeping procedure (see SAP for details).|LS mean difference to placebo|-2.61||||0.3782|TWO_SIDED|95.0|-8.41|3.197||Mixed effects model for repeated measures: change from baseline in LPS = baseline LPS + age group (\< 65; ≥ 65 years) + treatment + visit + treatment × visit + baseline × visit.|Mixed Models Analysis|Hypothesis testing result: threshold for significance p = 0.00195; statistically significant = NO||Between-treatment analysis for change from baseline in LPS (min) to Month 1 (Daridorexant 10 mg vs placebo).||3.197|-8.41|0.3782
72619474|NCT01557244|144769900|SUPERIORITY|||||||0.0765|||||||ANCOVA|||P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline number of micturitions per 24 hours and baseline weight.||||0.0765
72561548|NCT02250651|144653735|NON_INFERIORITY|MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.|Least-squares Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.39||0.0401||95.0|-1.57|-0.04|||MMRM|||Week 12, Hour 2: The hypothesis was that bimatoprost SR 15 μg was to be declared non-inferior to timolol 0.5% if the upper limit of the 95% CI was ≤ 1.5 mmHg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).||-0.04|-1.57|0.0401
72561549|NCT02250651|144653735|NON_INFERIORITY|MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.|Least-squares Mean Difference|-0.36|STANDARD_ERROR_OF_MEAN|0.39||0.3621|TWO_SIDED|95.0|-1.12|0.41|||MMRM|||Week 12, Hour 2: The hypothesis was that bimatoprost SR 10 μg was to be declared non-inferior to timolol 0.5% if the upper limit of the 95% CI was ≤ 1.5 mmHg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).||0.41|-1.12|0.3621
72561550|NCT02250651|144653736|SUPERIORITY|MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.|Least-squares Mean Difference|-0.76|STANDARD_ERROR_OF_MEAN|0.36||0.0382|TWO_SIDED|95.0|-1.48|-0.04|||MMRM|||Change from Baseline at Week 2, Hour 0: The hypothesis was that bimatoprost SR 15 μg was to be declared superior to timolol 0.5% if the upper limit of the 95% CI was \<0 mmHg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).||-0.04|-1.48|0.0382
72561551|NCT02250651|144653736|SUPERIORITY|MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.|Least-squares Mean Difference|-0.58|STANDARD_ERROR_OF_MEAN|0.36||0.1133|TWO_SIDED|95.0|-1.29|0.14|||MMRM|||Change from Baseline at Week 2, Hour 0: The hypothesis was that bimatoprost SR 10 μg was to be declared superior to timolol 0.5% if the upper limit of the 95% CI was \<0 mmHg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).||0.14|-1.29|0.1133
72561552|NCT02250651|144653736|SUPERIORITY|MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.|Least-squares Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|0.34||0.0013|TWO_SIDED|95.0|-1.76|-0.43|||MMRM|||Change from Baseline at Week 2, Hour 2: The hypothesis was that bimatoprost SR 15 μg was to be declared superior to timolol 0.5% if the upper limit of the 95% CI was \<0 mmHg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).||-0.43|-1.76|0.0013
72561553|NCT02250651|144653736|SUPERIORITY|MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.|Least-squares Mean Difference|-0.71|STANDARD_ERROR_OF_MEAN|0.34||0.0364|TWO_SIDED|95.0|-1.38|-0.05|||MMRM|||Change from Baseline at Week 2, Hour 2: The hypothesis was that bimatoprost SR 10 μg was to be declared superior to timolol 0.5% if the upper limit of the 95% CI was \<0 mmHg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).||-0.05|-1.38|0.0364
72619475|NCT01557244|144769900|SUPERIORITY|||||||0.0061|||||||ANCOVA|||P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline number of micturitions per 24 hours and baseline weight.||||0.0061
72619476|NCT01557244|144769900|OTHER||Difference in LS Mean|-0.1|||||TWO_SIDED|95.0|-1.16|0.97||||||||0.97|-1.16|
72619477|NCT01557244|144769900|OTHER||Difference in LS Mean|0.28|||||TWO_SIDED|95.0|-0.74|1.31||||||||1.31|-0.74|
72370183|NCT03085797|144250812|OTHER||Odds Ratio (OR)|0.58||||0.02|TWO_SIDED|95.0|0.36|0.92||p-Value was based on logistic regression model and is adjusted for multiplicity.|Regression, Logistic||Covariates: treatment group, geographic region, number of oral corticosteroids courses for NP in last 12 months(0,1,\>1 as ordinal), Baseline total endoscopic score(centrally read),Baseline nasal obstruction VAS score,log(e) Baseline eosinophil count.|||0.92|0.36|0.020
72390603|NCT02083783|144288929|SUPERIORITY||Mean Difference (Final Values)|-14.68|||<|0.0001|TWO_SIDED|95.0|-17.9|11.6|||ANCOVA|||Treatment difference in SKAMP-C scores from baseline to 4 hours postdose.||11.6|-17.9|<0.0001
72390604|NCT02083783|144288930|SUPERIORITY||Mean Difference (Final Values)|38.9|||<|0.0001|TWO_SIDED|95.0|27.3|50.6|||ANCOVA|||p-value for comparison between change from baseline in placebo vs active treatment||50.6|27.3|<0.0001
72390605|NCT00457301|144288951|SUPERIORITY_OR_OTHER_LEGACY||Slope|0.28|STANDARD_ERROR_OF_MEAN|0.1||0.05||95.0|||||ANCOVA|||Sample size was calculated based on the EQ-5D index score. To compare two independent means for a parallel trial design, 100 patients in each group were needed to detect a clinically important difference (CID) in EQ-5D index score (CID = 0.10, SD = 0.25) with a 5% probability of Type I error and 80% power.||||0.05
72390606|NCT00457301|144288952|SUPERIORITY_OR_OTHER_LEGACY|||||||0.34||95.0|||||ANCOVA|||ANCOVA adjuusting for baseline HADS anxiety scores||||0.34
72390607|NCT00457301|144288952|SUPERIORITY_OR_OTHER_LEGACY|||||||0.55||95.0|||||ANCOVA|||ANCOVA adjusting for baseline HADS depression scores.||||0.55
72390608|NCT00457301|144288953|SUPERIORITY_OR_OTHER_LEGACY||Slope|0.79|STANDARD_ERROR_OF_MEAN|0.23||0.001||95.0|||||ANCOVA|||||||0.001
72390609|NCT00457301|144288954|SUPERIORITY_OR_OTHER_LEGACY||Slope|0.01|STANDARD_ERROR_OF_MEAN|0.02||0.46||95.0|||||ANCOVA|||Sample size was calculated based on the EQ-5D index score. To compare two independent means for a parallel trial design, 100 patients in each group were needed to detect a clinically important difference (CID) in EQ-5D index score (CID = 0.10, SD = 0.25) with a 5% probability of Type I error and 80% power.||||0.46
72390610|NCT00147446|144288979|SUPERIORITY_OR_OTHER||Wilcoxon two smaple test statistics|2.09||||0.04||95.0|||||Wilcoxon (Mann-Whitney)|||It was hypothesized that treatment with stress management produced a significant reduction in cumulative Gd+ lesions compared to the control condition during the treatment period||||0.04
72498447|NCT03575104|144527454|OTHER|The Type I error rate was controlled for the testing of multiple null hypotheses associated with the endpoint assessed at 1 and 3 months of treatment and the two dose levels studied. Each null hypothesis was tested against the alternative hypothesis that daridorexant improved the endpoint at the given dose and time point compared to placebo. The order of testing and the alpha level applied to each null hypothesis was based on the Bonferroni-based gatekeeping procedure (see SAP for details).|LS mean difference to placebo|-9.01||||0.0053|TWO_SIDED|95.0|-15.339|-2.684||Mixed effects model for repeated measures: change from baseline in LPS = baseline LPS + age group (\< 65; ≥ 65 years) + treatment + visit + treatment × visit + baseline × visit.|Mixed Models Analysis|Hypothesis testing result: threshold for significance p = 0.00313; statistically significant = NO||Between-treatment analysis for change from baseline in LPS (min) to Month 3 (Daridorexant 25 mg vs placebo).||-2.684|-15.339|0.0053
72504796|NCT03114969|144540512|SUPERIORITY||Odds Ratio (OR)|5.408||||0.042|TWO_SIDED|95.0|1.059|27.61||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta+\[Relvar Ellipta+LAMA\] as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.|||27.610|1.059|0.042
72504797|NCT03114969|144540513|SUPERIORITY||Odds Ratio (OR)|12.145||||0.09|TWO_SIDED|95.0|0.68|216.818||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.|||216.818|0.680|0.090
72390611|NCT00147446|144288979|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.77||||0.02|TWO_SIDED|95.0|1.17|6.55|||Logistic Regression|||It was hypothesized that significantly greater numbers of participants receiving stress management remained free of Gd+ lesions during the treatment, compared to those receiving the control condition.||6.55|1.17|0.02
72390612|NCT00147446|144288980|SUPERIORITY_OR_OTHER||Wilcoxon two sample test statistics|2.84||||0.005||95.0|||||Wilcoxon (Mann-Whitney)|||It was hypothesized that participants receiving SMT-MS showed a significant reduction in cumulative new T2 lesions, compared to those receiving the control condition during the treatment period.||||0.005
72390613|NCT00147446|144288980|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.07||||0.006|TWO_SIDED|95.0|1.38|6.81|||Logistic Regression|||It was hypothesized that significantly greater numbers of participants receiving SMT-MS remained free of new T2 lesions during the treatment, compared to control condition participants.||6.81|1.38|0.006
72390614|NCT03307967|144288983|OTHER|||||||0.07|||||||Wilcoxon (Mann-Whitney)|Wilcoxon Signed Rank Sum||||||.07
72390615|NCT03307967|144288984|OTHER|||||||0.98|||||||Wilcoxon (Mann-Whitney)|Wilcoxon Signed Rank Sum Test||||||.98
72390616|NCT02761252|144289029|SUPERIORITY||Mean Difference (Final Values)|-0.194|STANDARD_ERROR_OF_MEAN|0.3429||0.5721|TWO_SIDED|95.0|-0.8693|0.4813|||ANCOVA|||||0.4813|-0.8693|0.5721
72390617|NCT02761252|144289030|SUPERIORITY||Mean Difference (Final Values)|-1.1552|STANDARD_ERROR_OF_MEAN|0.4489||0.0105|TWO_SIDED|95.0|-2.0379|-0.2725|||ANCOVA|||||-0.2725|-2.0379|0.0105
72390618|NCT02761252|144289031|SUPERIORITY||Mean Difference (Final Values)|-0.1393|STANDARD_ERROR_OF_MEAN|0.2009||0.4885|TWO_SIDED|95.0|-0.5342|0.2557|||ANCOVA|||||0.2557|-0.5342|0.4885
72390619|NCT02761252|144289032|SUPERIORITY||Mean Difference (Final Values)|-0.03615|STANDARD_ERROR_OF_MEAN|0.1504||0.81032|TWO_SIDED|95.0|-0.3319|0.2596|||ANCOVA|||||0.2596|-0.3319|0.81032
72390620|NCT02761252|144289033|OTHER||Mean Difference (Final Values)|0.8359|STANDARD_ERROR_OF_MEAN|0.9322||0.3704|TWO_SIDED|95.0|-0.9969|2.6688|||ANOVA|||||2.6688|-0.9969|0.3704
72390621|NCT02761252|144289034|SUPERIORITY||Median Difference (Final Values)|-0.837|STANDARD_ERROR_OF_MEAN|2.5735||0.7452|TWO_SIDED|95.0|-5.8968|4.2228|||ANOVA|||||4.2228|-5.8968|0.7452
72390622|NCT00381485|144289069|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||ANCOVA|||||||<0.001
72390623|NCT00381485|144289069|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||ANCOVA|||||||<0.001
72390624|NCT01206660|144289081|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
72390625|NCT01206660|144289082|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
72390626|NCT01206660|144289083|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
72390627|NCT03003390|144289102|SUPERIORITY||Posterior probabilities|0.09|||||TWO_SIDED||||||||||Using informative priors of B(1, 1) on the enoxaparin arm and B(18, 82) on the usual care arm, the risks of CADVT were 0.32 (95% CrI: 0.16, 0.51) in the enoxaparin arm and 0.25 (95% CrI: 0.18, 0.33) in the usual care arm. The posterior probability that the absolute difference in the risk of CADVT was lower by 0.06 in the enoxaparin arm was 9.1%. Using minimally informative priors, the risk ratio of CADVT with enoxaparin was 0.55 (95% CrI: 0.24, 1.11).|||
72390628|NCT03003390|144289103|SUPERIORITY|||||||0.22|||||||Linear mixed effects model|||||||0.22
72390629|NCT03003390|144289104|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.00
72390630|NCT03003390|144289105|SUPERIORITY|||||||0.31|||||||Wilcoxon (Mann-Whitney)|||||||0.31
72390631|NCT03003390|144289106|SUPERIORITY|||||||0.58|||||||Wilcoxon (Mann-Whitney)|||||||0.58
72504798|NCT03114969|144540513|SUPERIORITY||Odds Ratio (OR)|9.991||||0.13|TWO_SIDED|95.0|0.508|196.435||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.|||196.435|0.508|0.130
72390632|NCT03003390|144289107|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.00
72390633|NCT03003390|144289109|SUPERIORITY|||||||0.43|||||||Fisher Exact|||||||0.43
72390634|NCT01581931|144289141|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence margin: the 90% confidence intervall has to be within the intervall (80%, 125%)|Adjusted geometric mean ratio|97.69|STANDARD_DEVIATION|9.7|||TWO_SIDED|95.0|93.63|101.94|||ANOVA||Numerator: FDC tablet; denominator: single tablets of linagliptin and metformin; The dispersion parameter is actually the geometric coefficient of variation.|||101.94|93.63|
72504799|NCT03114969|144540514|SUPERIORITY||Odds Ratio (OR)|11.907||||0.079|TWO_SIDED|95.0|0.753|188.208||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.|||188.208|0.753|0.079
72390635|NCT01581931|144289144|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence margin: the 90% confidence intervall has to be within the intervall (80%, 125%)|Adjusted geometric mean ratio|97.76|STANDARD_DEVIATION|9.8|||TWO_SIDED|90.0|93.64|102.07|||ANOVA||Numerator: FDC tablet; denominator: single tablets of linagliptin and metformin; The dispersion parameter is actually the geometric coefficient of variation.|||102.07|93.64|
72390636|NCT01581931|144289145|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence margin: the 90% confidence intervall has to be within the intervall (80%, 125%)|Adjusted geometric mean ratio|98.79|STANDARD_DEVIATION|10.0|||TWO_SIDED|90.0|94.55|103.21|||ANOVA||Numerator: FDC tablet; denominator: single tablets of linagliptin and metformin; The dispersion parameter is actually the geometric coefficient of variation.|||103.21|94.55|
72390637|NCT00706823|144289149|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||t-test, 2 sided|||||||0.02
72390638|NCT00706823|144289150|SUPERIORITY_OR_OTHER|||||||0.22||95.0|||||Fisher Exact|||||||0.22
72390639|NCT00706823|144289152|SUPERIORITY_OR_OTHER|||||||0.22||95.0|||||t-test, 2 sided|||||||0.22
72390640|NCT00706823|144289154|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|8.11||||0.03|TWO_SIDED|95.0|1.1|58.6|||Regression, Logistic|||||58.6|1.1|0.03
72390641|NCT00590720|144289165|SUPERIORITY_OR_OTHER|||||||0.4|||||||Two-sample t-test|||||||0.40
72390642|NCT00590720|144289166|SUPERIORITY_OR_OTHER||||||<|0.01|||||||Two-sample t-test|||||||<0.01
72390643|NCT00590720|144289167|SUPERIORITY_OR_OTHER|||||||0.53|||||||Two-sample t-test|||||||0.53
72390644|NCT00590720|144289168|SUPERIORITY_OR_OTHER|||||||0.22|||||||Two-sample t-test|||||||0.22
72390645|NCT00590720|144289169|SUPERIORITY_OR_OTHER|||||||0.16|||||||Two-sample t-test|||||||0.16
72390646|NCT00590720|144289170|SUPERIORITY_OR_OTHER|||||||0.52|||||||Two-sample t-test|||||||0.52
72390647|NCT01001377|144289181|SUPERIORITY_OR_OTHER_LEGACY||Stratified Cox proportional hazard ratio|0.966|||||TWO_SIDED|95.0|0.839|1.113|||||Hazard ratio is presented as panitumumab : cetuximab. A value \< 1.0 indicates a lower average event rate and longer time to event for panitumumab relative to cetuximab.|Cox proportional hazards model stratified by geographic region (North America, western Europe and Australia vs rest of world) and ECOG performance status (0 or 1 vs 2).||1.113|0.839|
72390648|NCT01001377|144289181|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The overall survival non-inferiority hypothesis based on an asymptotic normal score was tested at a 1-sided 2.5% significance level. A value \< -1.96 indicates non-inferiority at a significance level of 1-sided 0.025.|Normal score|-3.19||||0.0007||||||A synthesis approach with an asymptotic standard normal test statistic|Asymptotic standard normal test|||A synthesis approach with an asymptotic standard normal test statistic based on the logarithm of the hazard ratio was used to test the hypothesis that panitumumab is non-inferior to cetuximab for overall survival (ie, that panitumumab retains at least 50% of the overall survival benefit of cetuximab relative to best supportive care).||||0.0007
72390649|NCT01001377|144289183|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.15|||||TWO_SIDED|95.0|0.83|1.58|||||Common treatment odds ratio stratified by geographic region (North America, western Europe and Australia vs rest of world) and ECOG performance status (0 or 1 vs 2).|||1.58|0.83|
72390650|NCT01001377|144289187|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.0126|||||TWO_SIDED|95.0|-0.0353|0.0605|||||A positive difference between the treatment groups favors the panitumumab group.|Repeated measures mixed model includes treatment, geographic region, ECOG score, assessment week, and treatment by assessment week interaction as fixed effects, and subjects a random effect. An unstructured covariance matrix is used in the mixed model.||0.0605|-0.0353|
72390651|NCT01001377|144289188|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.6745|||||TWO_SIDED|95.0|-4.9331|1.5841|||||A positive difference between the treatment groups favors the panitumumab group.|Repeated measures mixed model includes treatment, geographic region, ECOG score, assessment week, and treatment by assessment week interaction as fixed effects, and subjects a random effect. An unstructured covariance matrix is used in the mixed model.||1.5841|-4.9331|
72390652|NCT01001377|144289189|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|1.0372|||||TWO_SIDED|95.0|-2.3267|4.401|||||A positive difference between the treatment groups favors the panitumumab group.|Repeated measures mixed model includes treatment, geographic region, ECOG score, assessment week, and treatment by assessment week interaction as fixed effects, and subjects a random effect. An unstructured covariance matrix is used in the mixed model.||4.4010|-2.3267|
72390653|NCT01001377|144289190|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.5836|||||TWO_SIDED|95.0|-3.0269|4.1941|||||A positive difference between the treatment groups favors the panitumumab group.|Repeated measures mixed model includes treatment, geographic region, ECOG score, assessment week, and treatment by assessment week interaction as fixed effects, and subjects a random effect. An unstructured covariance matrix is used in the mixed model.||4.1941|-3.0269|
72390654|NCT01001377|144289191|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.1998|||||TWO_SIDED|95.0|-6.0093|5.6098|||||A positive difference between the treatment groups favors the panitumumab group.|Repeated measures mixed model includes treatment, geographic region, ECOG score, assessment week, and treatment by assessment week interaction as fixed effects, and subjects a random effect. An unstructured covariance matrix is used in the mixed model.||5.6098|-6.0093|
72390655|NCT02849678|144289219|NON_INFERIORITY|A total sample size of 64 subjects (32 patients in each arm) is required to detect a difference of 0.5 SD, using an alpha error of 0.05 and a power of 0.8. After enrollment of 47 patients, we decided to complete the present interim analysis, and the study was then interrupted due to equivalence in results between the two groups.||||||0.148|||||||t-test, 1 sided|||||||0.148
72504800|NCT03114969|144540514|SUPERIORITY||Odds Ratio (OR)|15.06||||0.063|TWO_SIDED|95.0|0.866|262.042||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.|||262.042|0.866|0.063
72561554|NCT02250651|144653736|SUPERIORITY|MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.|Least-squares Mean Difference|-0.46|STANDARD_ERROR_OF_MEAN|0.38||0.2304|TWO_SIDED|95.0|-1.22|0.29|||MMRM|||Change from Baseline at Week 6, Hour 0: The hypothesis was that bimatoprost SR 15 μg was to be declared superior to timolol 0.5% if the upper limit of the 95% CI was \<0 mmHg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).||0.29|-1.22|0.2304
72561555|NCT02250651|144653736|SUPERIORITY|MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.|Least-squares Mean Difference|-0.59|STANDARD_ERROR_OF_MEAN|0.38||0.1272|TWO_SIDED|95.0|-1.34|0.17|||MMRM|||Change from Baseline at Week 6, Hour 0: The hypothesis was that bimatoprost SR 10 μg was to be declared superior to timolol 0.5% if the upper limit of the 95% CI was \<0 mmHg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).||0.17|-1.34|0.1272
72561556|NCT02250651|144653736|SUPERIORITY|MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.|Least-squares Mean Difference|-1.05|STANDARD_ERROR_OF_MEAN|0.36||0.0038|TWO_SIDED|95.0|-1.76|-0.34|||MMRM|||Change from Baseline at Week 6, Hour 2: The hypothesis was that bimatoprost SR 15 μg was to be declared superior to timolol 0.5% if the upper limit of the 95% CI was \<0 mmHg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).||-0.34|-1.76|0.0038
72561557|NCT02250651|144653736|SUPERIORITY|MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.|Least-squares Mean Difference|-0.65|STANDARD_ERROR_OF_MEAN|0.36||0.0741|TWO_SIDED|95.0|-1.36|0.06|||MMRM|||Change from Baseline at Week 6, Hour 2: The hypothesis was that bimatoprost SR 10 μg was to be declared superior to timolol 0.5% if the upper limit of the 95% CI was \<0 mmHg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).||0.06|-1.36|0.0741
72561558|NCT03496298|144653737|NON_INFERIORITY|Non-inferiority of efpeglenatide 4 mg+6 mg versus placebo was to be claimed if the upper bound of the 2-sided 95% CI of the hazard ratio for the incidence of both 1.8 and less and 1.3 or less.|Hazard Ratio (HR)|0.732|||<|0.0001|TWO_SIDED|95.0|0.583|0.918||One-sided p-value based on log rank test of hazard ratio for the incidence of both 1.8 and less and 1.3 or less.|Log Rank|||Hazard ratio and 95% Confidence Interval (CI) were obtained from a Cox proportional hazards model with region (North America, Latin America, Europe, other), randomization stratum of SGLT2 inhibitor use (current use, potential future use, neither current nor potential future use) and treatment (efpeglenatide 4 mg, efpeglenatide 6 mg, placebo) as fixed effect factor.||0.918|0.583|<.0001
72561559|NCT03496298|144653738|SUPERIORITY|Superiority was claimed when the upper bound of the 2-sided 95% CI of hazard ratio was less than 1.|Hazard Ratio (HR)|0.732||||0.0069|TWO_SIDED|95.0|0.583|0.918||Two-sided p-values based on log rank test of hazard ratio.|Log Rank|||Hazard ratio and 95% CI were obtained from a Cox proportional hazards model with region (North America, Latin America, Europe, other), randomization stratum of SGLT2 inhibitor use (current use, potential future use, neither current nor potential future use) and treatment (efpeglenatide 4 mg, efpeglenatide 6 mg, placebo) as fixed effect factor.||0.918|0.583|0.0069
72561560|NCT03496298|144653739|SUPERIORITY|Superiority was claimed when the upper bound of the 2-sided 95% CI of hazard ratio was less than 1.|Hazard Ratio (HR)|0.79||||0.02|TWO_SIDED|95.0|0.65|0.96||Two-sided p-values based on log rank test of hazard ratio.|Log Rank|||Hazard ratio and 95% CI were obtained from a Cox proportional hazards model with region (North America, Latin America, Europe, other), randomization stratum of SGLT2 inhibitor use (current use, potential future use, neither current nor potential future use) and treatment (efpeglenatide 4 mg, efpeglenatide 6 mg, placebo) as fixed effect factor.||0.96|0.65|0.02
72561561|NCT03496298|144653740|SUPERIORITY|Superiority was claimed when the upper bound of the 2-sided 95% CI of hazard ratio was less than 1.|Hazard Ratio (HR)|0.675|||<|0.0001|TWO_SIDED|95.0|0.574|0.794||Two-sided p-values based on log rank test of hazard ratio.|Log Rank|||Hazard ratio and 95% CI were obtained from a Cox proportional hazards model with region (North America, Latin America, Europe, other), randomization stratum of SGLT2 inhibitor use (current use, potential future use, neither current nor potential future use) and treatment (efpeglenatide 4 mg, efpeglenatide 6 mg, placebo) as fixed effect factor.||0.794|0.574|<.0001
72561562|NCT01658995|144653741|SUPERIORITY||Risk Difference (RD)|-9.9||||0.37|TWO_SIDED|95.0|-31.4|11.6|||Chi-squared|||||11.6|-31.4|0.37
72561563|NCT01658995|144653742|SUPERIORITY|||||||0.46|||||||Chi-squared|||||||0.46
72561564|NCT02522780|144653754|SUPERIORITY||Odds Ratio (OR)|1.57|||>|0.05|TWO_SIDED|95.0|0.96|2.54||The p-value was based on Cochran-Mantel-Haenszel test by controlling pathway of randomization, at a 0.05 significance level.|Cochran-Mantel-Haenszel|||Proportions were compared between treatment groups at Month 6.||2.54|0.96|>0.05
72561565|NCT02522780|144653755|SUPERIORITY||Odds Ratio (OR)|1.24|||>|0.05|TWO_SIDED|95.0|0.76|2.03||The p-value was based on Generalized estimating equations (GEE) approach with binary outcomes (clinical remission) and an unstructured working correlation matrix, at a 0.05 significance level.|Generalised estimating equation approach|||Proportions were compared between treatment groups over 6 months.||2.03|0.76|>0.05
72561566|NCT02522780|144653756|SUPERIORITY||Hazard Ratio (HR)|0.6|||>|0.05|TWO_SIDED|95.0|0.25|1.44||The p-value was based on log-rank test using pathway of randomization as the stratification factor, at a 0.05 significance level.|Log Rank|||Times to relapse were compared between treatment groups up to 6 months.||1.44|0.25|>0.05
72561567|NCT02522780|144653757|SUPERIORITY||Odds Ratio (OR)|0.39|||<|0.05|TWO_SIDED|95.0|0.19|0.79||The p-value was based on Cochran-Mantel-Haenszel test by controlling pathway of randomization, at a 0.05 significance level.|Cochran-Mantel-Haenszel|||Proportions were compared between treatment groups at Month 6.||0.79|0.19|<0.05
72561568|NCT02522780|144653758|SUPERIORITY||Mean difference|-1.0|||>|0.05|TWO_SIDED|95.0|-2.7|0.7||The p-value was based on a repeated-measures analysis of covariance (ANCOVA) model with an unstructured correlation matrix , at a 0.05 significance level.|ANCOVA|||Adjusted mean treatment difference in CRP levels over 6 months was reported.||0.7|-2.7|>0.05
72448327|NCT04119843|144414082|SUPERIORITY|Reader success was achieved if the reading results demonstrated superiority of mangoral-enhanced MRI versus unenhanced MRI for both lesion border delineation and lesion contrast. The acceptance by two out of three readers was considered to be a successful demonstration of efficacy in the study.|Mean Difference (Final Values)|0.72|STANDARD_DEVIATION|0.786|<|0.001|TWO_SIDED|95.0|0.517|0.927|||t-test, 1 sided|p-values show a one-sided t-test with a significance level of 0.025.|Positive changes in lesion contrast mean difference (mangoral-enhanced MRI compared to unenhanced MRI) represents a better outcome.|Paired difference of mangoral-enhanced MRI versus unenhanced MRI: Reader 3||0.927|0.517|<0.001
72448328|NCT03994653|144414122|SUPERIORITY||Odds Ratio (OR)|2.91|||<|0.001|TWO_SIDED|95.0|2.07|4.12|||Fisher Exact|||"Fishers exact test, conducted at each month prior to diagnosis comparing total purchases of relevant products (pain and indigestion medication) compared with all purchases in both cases and controls.~Power calculation: we used a power calculation assuming the Fisher Exact Test to calculate the minimum group size to detect a difference in purchase proportions that we hypothesised with 80% statistical power."||4.12|2.07|<0.001
72448329|NCT05651308|144414200|SUPERIORITY||Risk Difference (RD)|0.026||||0.37|TWO_SIDED|95.0|-0.03|0.08|||Chi-squared||Risk difference = Intervention proportion minus control proportion.|||0.08|-0.03|0.37
72448330|NCT02714257|144414211|SUPERIORITY||Hazard Ratio (HR)|0.92||||0.43|TWO_SIDED|95.0|0.74|1.14|||Regression, Cox||Enhanced Usual Care - control group vs. Enhanced Usual Care plus Exercise Coaching Intervention|||1.14|0.74|0.43
72448331|NCT02714257|144414212|SUPERIORITY||Incidence Rate Ratio|1.06||||0.5|TWO_SIDED|95.0|0.89|1.28|||Regression, Negative Binomial||Enhanced Usual Care - control group vs. Enhanced Usual Care plus Exercise Coaching Intervention|||1.28|0.89|0.50
72498448|NCT03575104|144527454|OTHER|The Type I error rate was controlled for the testing of multiple null hypotheses associated with the endpoint assessed at 1 and 3 months of treatment and the two dose levels studied. Each null hypothesis was tested against the alternative hypothesis that daridorexant improved the endpoint at the given dose and time point compared to placebo. The order of testing and the alpha level applied to each null hypothesis was based on the Bonferroni-based gatekeeping procedure (see SAP for details).|LS mean difference to placebo|-3.19||||0.3233|TWO_SIDED|95.0|-9.528|3.146||Mixed effects model for repeated measures: change from baseline in LPS = baseline LPS + age group (\< 65; ≥ 65 years) + treatment + visit + treatment × visit + baseline × visit.|Mixed Models Analysis|Hypothesis testing result: threshold for significance p = 0; statistically significant = NO||Between-treatment analysis for change from baseline in LPS (min) to Month 3 (Daridorexant 10 mg vs placebo).||3.146|-9.528|0.3233
72448332|NCT02714257|144414213|SUPERIORITY||Odds Ratio (OR)|0.89||||0.3|TWO_SIDED|95.0|0.72|1.11|||Regression, Logistic|||||1.11|0.72|0.30
72498449|NCT03575104|144527455|OTHER|The Type I error rate was controlled for the testing of multiple null hypotheses associated with the endpoint assessed at 1 and 3 months of treatment and the two dose levels studied. Each null hypothesis was tested against the alternative hypothesis that daridorexant improved the endpoint at the given dose and time point compared to placebo. The order of testing and the alpha level applied to each null hypothesis was based on the Bonferroni-based gatekeeping procedure (see SAP for details).|LS mean difference to placebo|16.13|||<|0.0001|TWO_SIDED|95.0|8.224|24.035||Hypothesis testing result: threshold for significance p = 0.0125; statistically significant = YES|Mixed Models Analysis|||Between-treatment analysis for change from baseline in sTST (min) to Month 1 (Daridorexant 25 mg vs placebo).||24.035|8.224|<.0001
72498450|NCT03575104|144527455|OTHER|The Type I error rate was controlled for the testing of multiple null hypotheses associated with the endpoint assessed at 1 and 3 months of treatment and the two dose levels studied. Each null hypothesis was tested against the alternative hypothesis that daridorexant improved the endpoint at the given dose and time point compared to placebo. The order of testing and the alpha level applied to each null hypothesis was based on the Bonferroni-based gatekeeping procedure (see SAP for details).|LS mean difference to placebo|13.37|||=|0.0009|TWO_SIDED|95.0|5.507|21.226||Mixed effects model for repeated measures: change from baseline in sTST = baseline sTST + age group (\< 65; ≥ 65 years) + treatment + visit + treatment × visit + baseline × visit.|Mixed Models Analysis|Hypothesis testing result: threshold for significance p = 0; statistically significant = NO||Between-treatment analysis for change from baseline in sTST (min) to Month 1 (Daridorexant 10 mg vs placebo).||21.226|5.507|= 0.0009
72561569|NCT02522780|144653759|SUPERIORITY||Mean difference|-66.92|||>|0.05|TWO_SIDED|95.0|-140.2|6.36||The p-value was based on a repeated-measures ANCOVA model with an unstructured correlation matrix, at a 0.05 significance level.|ANCOVA|||Adjusted mean treatment difference in fecal calprotectin levels over 6 months was reported.||6.36|-140.2|>0.05
72561570|NCT02522780|144653760|SUPERIORITY||Mean difference|-0.32|||>|0.05|TWO_SIDED|95.0|-4.41|3.77||The p-value was based on a repeated-measures ANCOVA model with an unstructured correlation matrix, at a 0.05 significance level.|ANCOVA|||Adjusted mean treatment difference in IBDQ total scores over 6 months was reported.||3.77|-4.41|>0.05
72619478|NCT01557244|144769901|SUPERIORITY|||||||0.0787|||||||ANCOVA|||P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline number of catheterizations per 24 hours and baseline weight.||||0.0787
72619479|NCT01557244|144769901|SUPERIORITY|||||||0.0727|||||||ANCOVA|||P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline number of catheterizations per 24 hours and baseline weight.||||0.0727
72448333|NCT02714257|144414214|SUPERIORITY||Mean Difference (Final Values)|0.54|||<|0.01|TWO_SIDED|95.0|0.16|0.92|||Mixed Models Analysis||Enhanced Usual Care - control group vs. Enhanced Usual Care plus Exercise Coaching Intervention|||0.92|0.16|<0.01
72448334|NCT02714257|144414215|SUPERIORITY||Odds Ratio (OR)|1.04||||0.73|TWO_SIDED|95.0|0.85|1.27|||Regression, Logistic||Enhanced Usual Care - control group vs. Enhanced Usual Care plus Exercise Coaching Intervention|||1.27|0.85|0.73
72448335|NCT02714257|144414216|SUPERIORITY||Mean Difference (Final Values)|0.22||||0.27|TWO_SIDED|95.0|-0.18|0.62|||Mixed Models Analysis||Enhanced Usual Care - control group vs. Enhanced Usual Care plus Exercise Coaching Intervention|||0.62|-0.18|0.27
72448336|NCT02714257|144414217|SUPERIORITY||Mean Difference (Final Values)|0.11||||0.37|TWO_SIDED|95.0|-0.13|0.34|||Mixed Models Analysis||Enhanced Usual Care - control group vs. Enhanced Usual Care plus Exercise Coaching Intervention|||0.34|-0.13|0.37
72448337|NCT02714257|144414218|SUPERIORITY||Mean Difference (Final Values)|0.14||||0.26|TWO_SIDED|95.0|-0.1|0.38|||Mixed Models Analysis||Enhanced Usual Care - control group vs. Enhanced Usual Care plus Exercise Coaching Intervention|||0.38|-0.10|0.26
72561571|NCT02058160|144653766|SUPERIORITY_OR_OTHER||Least square (LS) mean difference|-0.52|STANDARD_ERROR_OF_MEAN|0.06|<|0.0001|TWO_SIDED|95.0|-0.633|-0.397||Threshold for significance at 0.05 level.|Mixed Models Analysis||Insulin Glargine/Lixisenatide FRC vs Insulin Glargine|Analysis was performed using Mixed-effect model with repeated measures (MMRM) with treatment groups, randomization strata of Week -1 HbA1c (\<8.0, ≥8.0%), randomization strata of metformin use at screening, visits, treatment-by-visit interaction and country as fixed effects and baseline HbA1c value-by-visit interaction as covariates. A hierarchical testing procedure was used to control type I error and handle multiple endpoint analyses.||-0.397|-0.633|<0.0001
72619480|NCT01557244|144769901|SUPERIORITY|||||||0.0666|||||||ANCOVA|||P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline number of catheterizations per 24 hours and baseline weight.||||0.0666
72390656|NCT02849678|144289221|NON_INFERIORITY|A total sample size of 64 subjects (32 patients in each arm) is required to detect a difference of 0.5 SD, using an alpha error of 0.05 and a power of 0.8. After enrollment of 47 patients, we decided to complete the present interim analysis, and the study was then interrupted due to equivalence in results between the two groups.||||||0.636|||||||t-test, 1 sided|||||||.636
72390657|NCT02849678|144289223|NON_INFERIORITY|A total sample size of 64 subjects (32 patients in each arm) is required to detect a difference of 0.5 SD, using an alpha error of 0.05 and a power of 0.8. After enrollment of 47 patients, we decided to complete the present interim analysis, and the study was then interrupted due to equivalence in results between the two groups.||||||0.193||||||Hydromorphone consumption (mg) in Post-Anesthesia Care Unit (PACU)|t-test, 2 sided|||||||0.193
72390658|NCT02849678|144289223|NON_INFERIORITY|A total sample size of 64 subjects (32 patients in each arm) is required to detect a difference of 0.5 SD, using an alpha error of 0.05 and a power of 0.8. After enrollment of 47 patients, we decided to complete the present interim analysis, and the study was then interrupted due to equivalence in results between the two groups.||||||0.635||||||Hydromorphone consumption (mg) in PACU versus at 24 hours versus 48 hours|ANOVA|||||||0.635
72390659|NCT02849678|144289224|NON_INFERIORITY|A total sample size of 64 subjects (32 patients in each arm) is required to detect a difference of 0.5 SD, using an alpha error of 0.05 and a power of 0.8. After enrollment of 47 patients, we decided to complete the present interim analysis, and the study was then interrupted due to equivalence in results between the two groups.||||||0.063|||||||ANOVA|Local Anesthetic Consumption through para-vertebral catheters in PACU vs. at 24 hours vs. 48 hours||||||0.063
72390660|NCT03982368|144289267|SUPERIORITY||least square mean difference|0.93||||0.078|TWO_SIDED|95.0|-1.47|3.32|||ANOVA|||The primary endpoint was analyzed using analysis of variance (ANOVA) including only treatment as the main factor, followed by preplanned comparisons from vehicle and rhNGF dosages according to Williams' procedure.||3.32|-1.47|0.078
72390661|NCT03982368|144289267|SUPERIORITY||least square mean difference|2.31||||0.066|TWO_SIDED|95.0|-0.08|4.7|||ANOVA|||The primary endpoint was analyzed using analysis of variance (ANOVA) including only treatment as the main factor, followed by preplanned comparisons from vehicle and rhNGF dosages according to Williams' procedure.||4.70|-0.08|0.066
72390662|NCT03982368|144289268|SUPERIORITY||Least square mean difference|1.71||||0.032|TWO_SIDED|95.0|-0.7|4.12|||ANOVA|||||4.12|-0.70|0.032
72390663|NCT03982368|144289268|SUPERIORITY||Least square mean difference|2.44||||0.029|TWO_SIDED|95.0|0.02|4.86|||ANOVA|||||4.86|0.02|0.029
72390664|NCT03982368|144289269|SUPERIORITY|||||||0.534|||||||t-test, 2 sided|||||||0.534
72390665|NCT03982368|144289269|SUPERIORITY|||||||0.611|||||||t-test, 2 sided|||||||0.611
72390666|NCT03982368|144289270|SUPERIORITY|||||||0.486|||||||t-test, 2 sided|||||||0.486
72390667|NCT03982368|144289270|SUPERIORITY|||||||0.564|||||||t-test, 2 sided|||||||0.564
72390668|NCT03982368|144289272|SUPERIORITY|||||||0.81|||||||t-test, 2 sided|||||||0.810
72390669|NCT03982368|144289272|SUPERIORITY|||||||0.733|||||||t-test, 2 sided|||||||0.733
72390670|NCT03982368|144289273|SUPERIORITY||Least square mean difference|1.97||||0.025|TWO_SIDED|95.0|-0.19|4.13|||ANOVA|||The secondary endpoint was analyzed using analysis of variance (ANOVA) including only treatment as the main factor, followed by preplanned comparisons from vehicle and rhNGF dosages according to Williams' procedure.||4.13|-0.19|0.025
72390671|NCT03982368|144289273|SUPERIORITY||Least square mean difference|0.68||||0.243|TWO_SIDED|95.0|-1.48|2.83|||ANOVA|||The secondary endpoint was analyzed using analysis of variance (ANOVA) including only treatment as the main factor, followed by preplanned comparisons from vehicle and rhNGF dosages according to Williams' procedure.||2.83|-1.48|0.243
72390672|NCT03982368|144289274|SUPERIORITY||Least square mean difference|2.41||||0.007|TWO_SIDED|95.0|0.28|4.54|||ANOVA|||||4.54|0.28|0.007
72390673|NCT03982368|144289274|SUPERIORITY||Least square mean difference|0.71||||0.23|TWO_SIDED|95.0|-1.43|2.85|||ANOVA|||||2.85|-1.43|0.230
72390674|NCT03982368|144289275|SUPERIORITY||Least square mean difference|-1.16||||0.799|TWO_SIDED|95.0|-3.11|0.8|||ANOVA|Last Observation Carried Forward (LOCF) was used for imputing missing data in the Full analysis set at Week 4.||"The secondary endpoint was analyzed using analysis of variance (ANOVA) including only treatment as the main factor, followed by preplanned comparisons from vehicle and rhNGF dosages according to Williams' procedure.~p value for total corneal ancd conjunctival score is reported."||0.80|-3.11|0.799
72390675|NCT03982368|144289275|SUPERIORITY||Least square mean difference|-0.36||||0.715|TWO_SIDED|95.0|-2.3|1.59|||ANOVA|||The secondary endpoint was analyzed using analysis of variance (ANOVA) including only treatment as the main factor, followed by preplanned comparisons from vehicle and rhNGF dosages according to Williams' procedure.||1.59|-2.30|0.715
72390676|NCT03982368|144289276|SUPERIORITY||Least square mean difference|-1.54||||0.831|TWO_SIDED|95.0|-3.4|0.31|||ANOVA|||"The secondary endpoint was analyzed using analysis of variance (ANOVA) including only treatment as the main factor, followed by preplanned comparisons from vehicle and rhNGF dosages according to Williams' procedure.~p value for total corneal ancd conjunctival score is reported."||0.31|-3.40|0.831
72390677|NCT03982368|144289276|SUPERIORITY||Least square mean difference|-0.21||||0.75|TWO_SIDED|95.0|-2.07|1.66|||ANOVA|||"The secondary endpoint was analyzed using analysis of variance (ANOVA) including only treatment as the main factor, followed by preplanned comparisons from vehicle and rhNGF dosages according to Williams' procedure.~p value for total corneal ancd conjunctival score is reported."||1.66|-2.07|0.750
72390678|NCT03982368|144289277|SUPERIORITY||Least square mean difference|0.96||||0.004|TWO_SIDED|95.0|0.17|1.75|||ANOVA|||||1.75|0.17|0.004
72390679|NCT03982368|144289277|SUPERIORITY||Least square mean difference|0.28||||0.217|TWO_SIDED|95.0|-0.51|1.07|||ANOVA|||||1.07|-0.51|0.217
72498451|NCT03575104|144527456|OTHER|The Type I error rate was controlled for the testing of multiple null hypotheses associated with the endpoint assessed at 1 and 3 months of treatment and the two dose levels studied. Each null hypothesis was tested against the alternative hypothesis that daridorexant improved the endpoint at the given dose and time point compared to placebo. The order of testing and the alpha level applied to each null hypothesis was based on the Bonferroni-based gatekeeping procedure (see SAP for details).|LS mean difference to placebo|19.06|||<|0.0001|TWO_SIDED|95.0|10.125|27.994||Mixed effects model for repeated measures: change from baseline in sTST = baseline sTST + age group (\< 65; ≥ 65 years) + treatment + visit + treatment × visit + baseline × visit.|Mixed Models Analysis|Hypothesis testing result: threshold for significance p = 0.00781; statistically significant = YES||Between-treatment analysis for change from baseline in sTST (min) to Month 3 (Daridorexant 25 mg vs placebo).||27.994|10.125|<.0001
72498452|NCT03575104|144527456|OTHER|The Type I error rate was controlled for the testing of multiple null hypotheses associated with the endpoint assessed at 1 and 3 months of treatment and the two dose levels studied. Each null hypothesis was tested against the alternative hypothesis that daridorexant improved the endpoint at the given dose and time point compared to placebo. The order of testing and the alpha level applied to each null hypothesis was based on the Bonferroni-based gatekeeping procedure (see SAP for details).|LS mean difference to placebo|13.58|||=|0.0028|TWO_SIDED|95.0|4.691|22.475||Mixed effects model for repeated measures: change from baseline in sTST = baseline sTST + age group (\< 65; ≥ 65 years) + treatment + visit + treatment × visit + baseline × visit.|Mixed Models Analysis|Hypothesis testing result: threshold for significance p = 0; statistically significant = NO||Between-treatment analysis for change from baseline in sTST (min) to Month 3 (Daridorexant 10 mg vs placebo).||22.475|4.691|= 0.0028
72390680|NCT03982368|144289278|SUPERIORITY||Least square mean difference|0.92||||0.007|TWO_SIDED|95.0|0.1|1.74|||ANOVA|||||1.74|0.10|0.007
72390681|NCT03982368|144289278|SUPERIORITY||Least square mean difference|0.28||||0.225|TWO_SIDED|95.0|-0.54|1.1|||ANOVA|||||1.10|-0.54|0.225
72390682|NCT03982368|144289279|SUPERIORITY|||||||0.68|||||||t-test, 2 sided|||||||0.680
72390683|NCT03982368|144289279|SUPERIORITY|||||||0.066|||||||t-test, 2 sided|||||||0.066
72390684|NCT03982368|144289280|SUPERIORITY|||||||0.097|||||||Chi-squared|||||||0.097
72390685|NCT03982368|144289280|SUPERIORITY|||||||0.076|||||||Chi-squared|||||||0.076
72390686|NCT03982368|144289281|SUPERIORITY||Least square mean difference|16.4||||0.289|TWO_SIDED|95.0|12.0|20.8|||ANOVA|||Daily Activity Limitations - change from baseline to week 4||20.8|12.0|0.289
72390687|NCT03982368|144289281|SUPERIORITY||Least square mean difference|19.7||||0.032|TWO_SIDED|95.0|15.4|24.0|||ANOVA|||Daily Activity Limitations - change from baseline to week 4||24.0|15.4|0.032
72390688|NCT03982368|144289281|SUPERIORITY||Least square mean difference|16.4||||0.095|TWO_SIDED|95.0|11.9|20.8|||ANOVA|||Daily Activity Limitations - change to baseline to week 8||20.8|11.9|0.095
72390689|NCT03982368|144289281|SUPERIORITY||Least square mean difference|14.5||||0.282|TWO_SIDED|95.0|10.1|18.8|||ANOVA|||Daily Activity Limitations - change from baseline to week 8||18.8|10.1|0.282
72390690|NCT03982368|144289281|SUPERIORITY||Least square mean difference|15.0||||0.169|TWO_SIDED|95.0|10.6|19.4|||ANOVA|||Daily Activity Limitations - change from baseline to week 12||19.4|10.6|0.169
72390691|NCT03982368|144289281|SUPERIORITY||Least square mean difference|15.4||||0.129|TWO_SIDED|95.0|11.1|19.7|||ANOVA|||Daily Activity Limitations - change from baseline to week 12||19.7|11.1|0.129
72390692|NCT03982368|144289281|SUPERIORITY||Least square mean difference|14.0||||0.111|TWO_SIDED|95.0|9.7|18.4|||ANOVA|||Daily Activity Limitations - change from baseline to week 16||18.4|9.7|0.111
72390693|NCT03982368|144289281|SUPERIORITY||Least square mean difference|14.0||||0.107|TWO_SIDED|95.0|9.7|18.3|||ANOVA|||Daily Activity Limitations - change from baseline to week 16||18.3|9.7|0.107
72390694|NCT03982368|144289281|SUPERIORITY||Least square mean difference|14.3||||0.827|TWO_SIDED|95.0|9.7|18.9|||ANOVA|||Emotional Well-Being - change from baseline to week 4||18.9|9.7|0.827
72390695|NCT03982368|144289281|SUPERIORITY||Least square mean difference|16.3||||0.688|TWO_SIDED|95.0|11.8|20.8|||ANOVA|||Emotional Well-Being - change from baseline to week 4||20.8|11.8|0.688
72390696|NCT03982368|144289281|SUPERIORITY||Least square mean difference|15.7||||0.324|TWO_SIDED|95.0|11.4|20.0|||ANOVA|||Emotional Well-Being - change from baseline to week 8||20.0|11.4|0.324
72390697|NCT03982368|144289281|SUPERIORITY||Least square mean difference|12.9||||0.949|TWO_SIDED|95.0|8.7|17.1|||ANOVA|||Emotional Well-Being - change from baseline to week 8||17.1|8.7|0.949
72390698|NCT03982368|144289281|SUPERIORITY||Least square mean difference|15.7||||0.927|TWO_SIDED|95.0|11.4|20.1|||ANOVA|||Emotional Well-Being - change from baseline to week 12||20.1|11.4|0.927
72390699|NCT03982368|144289281|SUPERIORITY||Least square mean difference|14.8||||0.776|TWO_SIDED|95.0|10.8|18.8|||ANOVA|||Emotional Well-Being - change from baseline to week 12||18.8|10.8|0.776
72390700|NCT03982368|144289281|SUPERIORITY||Least square mean difference|15.7||||0.418|TWO_SIDED|95.0|11.4|20.1|||ANOVA|||Emotional Well-Being - change from baseline to week 16||20.1|11.4|0.418
72390701|NCT03982368|144289281|SUPERIORITY||Least square mean difference|14.8||||0.613|TWO_SIDED|95.0|10.6|19.0|||ANOVA|||Emotional Well-Being - change from baseline to week 16||19.0|10.6|0.613
72390702|NCT03982368|144289281|SUPERIORITY||Least square mean difference|15.8||||0.721|TWO_SIDED|95.0|8.3|23.2|||ANOVA|||Work Limitations - change from baseline to week 4||23.2|8.3|0.721
72390703|NCT03982368|144289281|SUPERIORITY||Least square mean difference|20.6||||0.558|TWO_SIDED|95.0|13.1|28.0|||ANOVA|||Work Limitations - change from baseline to week 4||28.0|13.1|0.558
72390704|NCT03982368|144289281|SUPERIORITY||Least square mean difference|18.4||||0.809|TWO_SIDED|95.0|11.5|25.3|||ANOVA|||Work Limitations - change from baseline to week 8||25.3|11.5|0.809
72390705|NCT03982368|144289281|SUPERIORITY||Least square mean difference|19.4||||0.651|TWO_SIDED|95.0|12.4|26.4|||ANOVA|||Work Limitations - change from baseline to week 8||26.4|12.4|0.651
72390706|NCT03982368|144289281|SUPERIORITY||Least square mean difference|16.4||||0.769|TWO_SIDED|95.0|9.5|23.3|||ANOVA|||Work Limitations - change from baseline to week 12||23.3|9.5|0.769
72390707|NCT03982368|144289281|SUPERIORITY||Least square mean difference|21.3||||0.454|TWO_SIDED|95.0|14.3|28.3|||ANOVA|||Work Limitations - change from baseline to week 12||28.3|14.3|0.454
72390708|NCT03982368|144289281|SUPERIORITY||Least square mean difference|18.3||||0.564|TWO_SIDED|95.0|11.6|25.0|||ANOVA|||Work Limitations - change from baseline to week 16||25.0|11.6|0.564
72448338|NCT02714257|144414219|SUPERIORITY||Mean Difference (Final Values)|0.07||||0.39|TWO_SIDED|95.0|-0.09|0.22|||Mixed Models Analysis||Enhanced Usual Care - control group vs. Enhanced Usual Care plus Exercise Coaching Intervention|||0.22|-0.09|0.39
72448339|NCT05825755|144414220|SUPERIORITY|||||||0.252|||||||Wilcoxon (Mann-Whitney)|||||||0.252
72619481|NCT01557244|144769901|OTHER||Difference in LS Mean|0.04|||||TWO_SIDED|95.0|-0.45|0.54||||||||0.54|-0.45|
72448340|NCT05825755|144414221|SUPERIORITY|||||||1|||||||McNemar|||||||1.0
72448341|NCT05825755|144414222|SUPERIORITY|||||||0.791|||||||Wilcoxon (Mann-Whitney)|||||||0.791
72504801|NCT03114969|144540515|SUPERIORITY||Odds Ratio (OR)|2.67||||0.239|TWO_SIDED|95.0|0.521|13.69||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta+\[Relvar Ellipta+LAMA\] as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.|||13.690|0.521|0.239
72619482|NCT01557244|144769901|OTHER||Difference in LS Mean|0.02|||||TWO_SIDED|95.0|-0.49|0.52||||||||0.52|-0.49|
72619483|NCT01557244|144769902|SUPERIORITY|||||||0.0111|||||||ANCOVA|||P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline number of micturitions and catheterizations combined per 24 hours and baseline weight.||||0.0111
72619484|NCT01557244|144769902|SUPERIORITY|||||||0.0171|||||||ANCOVA|||P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline number of micturitions and catheterizations combined per 24 hours and baseline weight.||||0.0171
72390709|NCT03982368|144289281|SUPERIORITY||Least square mean difference|21.0||||0.25|TWO_SIDED|95.0|14.1|27.8|||ANOVA|||Work Limitations - change from baseline to week 16||27.8|14.1|0.250
72390710|NCT03982368|144289281|SUPERIORITY||Least square mean difference|23.9||||0.853|TWO_SIDED|95.0|15.6|32.2|||ANOVA|||Treatment Satisfaction - change from baseline to week 4||32.2|15.6|0.853
72390711|NCT03982368|144289281|SUPERIORITY||Least square mean difference|20.0||||0.393|TWO_SIDED|95.0|11.9|28.0|||ANOVA|||Treatment Satisfaction - change from baseline to week 4||28.0|11.9|0.393
72390712|NCT03982368|144289281|SUPERIORITY||Least square mean difference|27.9||||0.01|TWO_SIDED|95.0|20.2|35.6|||ANOVA|||Treatment Satisfaction - change from baseline to week 8||35.6|20.2|0.010
72390713|NCT03982368|144289281|SUPERIORITY||Least square mean difference|18.3||||0.395|TWO_SIDED|95.0|11.1|25.4|||ANOVA|||Treatment Satisfaction - change from baseline to week 8||25.4|11.1|0.395
72390714|NCT03982368|144289281|SUPERIORITY||Least square mean difference|24.8||||0.068|TWO_SIDED|95.0|17.1|32.4|||ANOVA|||Treatment Satisfaction - change from baseline to week 12||32.4|17.1|0.068
72390715|NCT03982368|144289281|SUPERIORITY||Least square mean difference|19.3||||0.4|TWO_SIDED|95.0|12.2|26.4|||ANOVA|||Treatment Satisfaction - change from baseline to week 12||26.4|12.2|0.400
72390716|NCT03982368|144289281|SUPERIORITY||Least square mean difference|25.5||||0.021|TWO_SIDED|95.0|18.1|33.0|||ANOVA|||Treatment Satisfaction - change from baseline to week 16||33.0|18.1|0.021
72390717|NCT03982368|144289281|SUPERIORITY||Least square mean difference|23.1||||0.056|TWO_SIDED|95.0|16.1|30.0|||ANOVA|||Treatment Satisfaction - change from baseline to week 16||30.0|16.1|0.056
72390718|NCT03982368|144289281|SUPERIORITY||Least square mean difference|14.2||||0.981|TWO_SIDED|95.0|7.6|20.7|||ANOVA|||Treatment-Related Bother - change from baseline to week 4||20.7|7.6|0.981
72390719|NCT03982368|144289281|SUPERIORITY||Least square mean difference|17.0||||0.525|TWO_SIDED|95.0|11.1|22.9|||ANOVA|||Treatment-Related Bother - change from baseline to week 4||22.9|11.1|0.525
72390720|NCT03982368|144289281|SUPERIORITY||Least square mean difference|9.5||||0.356|TWO_SIDED|95.0|2.9|16.0|||ANOVA|||Treatment-Related Bother - change from baseline to week 8||16.0|2.9|0.356
72390721|NCT03982368|144289281|SUPERIORITY||Least square mean difference|6.5||||0.771|TWO_SIDED|95.0|0.7|12.4|||ANOVA|||Treatment-Related Bother - change from baseline to week 8||12.4|0.7|0.771
72390722|NCT03982368|144289281|SUPERIORITY||Least square mean difference|8.7||||0.926|TWO_SIDED|95.0|2.0|15.5|||ANOVA|||Treatment-Related Bother - change from baseline to week 12||15.5|2.0|0.926
72390723|NCT03982368|144289281|SUPERIORITY||Least square mean difference|7.9||||0.778|TWO_SIDED|95.0|1.9|13.9|||ANOVA|||Treatment-Related Bother - change from baseline to week 12||13.9|1.9|0.778
72390724|NCT03982368|144289281|SUPERIORITY||Least square mean difference|10.0||||0.984|TWO_SIDED||||||ANOVA|||Treatment-Related Bother - change from baseline to week 16||||0.984
72390725|NCT03982368|144289281|SUPERIORITY||Least square mean difference|7.4||||0.514|TWO_SIDED|95.0|1.6|13.1|||ANOVA|||Treatment-Related Bother - change from baseline to week 16||13.1|1.6|0.514
72390726|NCT03982368|144289281|SUPERIORITY||Least square mean difference|-16.6||||0.985|TWO_SIDED|95.0|-20.4|-12.8|||ANOVA|||Symptom Bother - change from baseline to week 4||-12.8|-20.4|0.985
72390727|NCT03982368|144289281|SUPERIORITY||Least square mean difference|-17.8||||0.646|TWO_SIDED|95.0|-21.5|-14.0|||ANOVA|||Symptom Bother - change from baseline to week 4||-14.0|-21.5|0.646
72390728|NCT03982368|144289281|SUPERIORITY||Least square mean difference|-20.7||||0.007|TWO_SIDED|95.0|-24.5|-16.9|||ANOVA|||Symptom Bother - change from baseline to week 8||-16.9|-24.5|0.007
72390729|NCT03982368|144289281|SUPERIORITY||Least square mean difference|-16.2||||0.305|TWO_SIDED|95.0|-19.9|-12.5|||ANOVA|||Symptom Bother - change from baseline to week 8||-12.5|-19.9|0.305
72390730|NCT03982368|144289281|SUPERIORITY||Least square mean difference|-19.0||||0.015|TWO_SIDED|95.0|-22.7|-15.4|||ANOVA|||Symptom Bother - change from baseline to week 12||-15.4|-22.7|0.015
72390731|NCT03982368|144289281|SUPERIORITY||Least square mean difference|-18.0||||0.039|TWO_SIDED|95.0|-21.5|-14.4|||ANOVA|||Symptom Bother - change from baseline to week 12||-14.4|-21.5|0.039
72390732|NCT03982368|144289281|SUPERIORITY||Least square mean difference|-19.7||||0.001|TWO_SIDED|95.0|-23.3|-16.0|||ANOVA|||||-16.0|-23.3|0.001
72390733|NCT03982368|144289281|SUPERIORITY||Least square mean difference|-18.9||||0.002|TWO_SIDED|95.0|-22.4|-15.3|||ANOVA|||Symptom Bother - change from baseline to week 16||-15.3|-22.4|0.002
72390734|NCT03982368|144289282|SUPERIORITY||Least square mean difference|16.8||||0.241|TWO_SIDED|95.0|12.2|21.4|||ANOVA|||Daily Activity Limitations - change from baseline to week 4||21.4|12.2|0.241
72390735|NCT03982368|144289282|SUPERIORITY||Least square mean difference|19.7||||0.04|TWO_SIDED|95.0|15.1|24.4|||ANOVA|||Daily Activity Limitations - change from baseline to week 4||24.4|15.1|0.040
72619485|NCT01557244|144769902|SUPERIORITY|||||||0.0028|||||||ANCOVA|||P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline number of micturitions and catheterizations combined per 24 hours and baseline weight.||||0.0028
72619486|NCT01557244|144769902|OTHER||Difference in LS Mean|0.14|||||TWO_SIDED|95.0|-0.53|0.82||||||||0.82|-0.53|
72619487|NCT01557244|144769902|OTHER||Difference in LS Mean|0.15|||||TWO_SIDED|95.0|-0.54|0.84||||||||0.84|-0.54|
72619488|NCT01557244|144769903|SUPERIORITY|||||||0.0496|||||||ANCOVA|||P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline number of incontinence episodes per 24 hours and baseline weight.||||0.0496
72619489|NCT01557244|144769903|SUPERIORITY|||||||0.0002|||||||ANCOVA|||P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline number of incontinence episodes per 24 hours and baseline weight.||||0.0002
72619490|NCT01557244|144769903|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline number of incontinence episodes per 24 hours and baseline weight.||||<.0001
72448342|NCT04103580|144414227|SUPERIORITY||Slope|0.005|STANDARD_ERROR_OF_MEAN|0.005||0.247|TWO_SIDED||||||Mixed Models Analysis|Due to uneven space between time points (days), we estimated a random effects model with varying intercepts and slopes for each phase independently.|We used an interaction between time and study arm to determine whether there was a significant difference over time in the change in outcome. The estimate is the difference in change over time for the intervention group compared to the control group.|The null hypothesis is that there is no difference between control and intervention over time in Phase 1.||||0.247
72498453|NCT03575104|144527457|OTHER|The Type I error rate was controlled for the testing of multiple null hypotheses associated with the endpoint assessed at 1 and 3 months of treatment and the two dose levels studied. Each null hypothesis was tested against the alternative hypothesis that daridorexant improved the endpoint at the given dose and time point compared to placebo. The order of testing and the alpha level applied to each null hypothesis was based on the Bonferroni-based gatekeeping procedure (see SAP for details).|LS mean difference to placebo|-0.75|||=|0.0733|TWO_SIDED|95.0|-1.581|0.071||Mixed effects model for repeated measures: change from baseline in IDSIQ sleepiness domain score = baseline IDSIQ sleepiness domain score + age group (\< 65; ≥ 65 years) + treatment + visit + treatment × visit + baseline × visit.|Mixed Models Analysis|Hypothesis testing result: threshold for significance p = 0.00625; statistically significant = NO||Between-treatment analysis for change from baseline in IDSIQ sleepiness domain score to Month 1 (Daridorexant 25 mg vs placebo).||0.071|-1.581|= 0.0733
72498454|NCT03575104|144527457|OTHER|The Type I error rate was controlled for the testing of multiple null hypotheses associated with the endpoint assessed at 1 and 3 months of treatment and the two dose levels studied. Each null hypothesis was tested against the alternative hypothesis that daridorexant improved the endpoint at the given dose and time point compared to placebo. The order of testing and the alpha level applied to each null hypothesis was based on the Bonferroni-based gatekeeping procedure (see SAP for details).|LS mean difference to placebo|-0.43|||=|0.3048|TWO_SIDED|95.0|-1.251|0.392||Mixed effects model for repeated measures: change from baseline in IDSIQ sleepiness domain score = baseline IDSIQ sleepiness domain score + age group (\< 65; ≥ 65 years) + treatment + visit + treatment × visit + baseline × visit.|Mixed Models Analysis|Hypothesis testing result: threshold for significance p = 0; statistically significant = NO||Between-treatment analysis for change from baseline in IDSIQ sleepiness domain score to Month 1 (Daridorexant 10 mg vs placebo).||0.392|-1.251|= 0.3048
72504802|NCT03114969|144540515|SUPERIORITY||Odds Ratio (OR)|2.929||||0.2|TWO_SIDED|95.0|0.567|15.125||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta+\[Relvar Ellipta+LAMA\] as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.|||15.125|0.567|0.200
72619491|NCT01557244|144769903|OTHER||Difference in LS Mean|0.55|||||TWO_SIDED|95.0|-0.09|1.19||||||||1.19|-0.09|
72619492|NCT01557244|144769903|OTHER||Difference in LS Mean|0.12|||||TWO_SIDED|95.0|-0.52|0.77||||||||0.77|-0.52|
72619493|NCT01557244|144769904|SUPERIORITY|||||||0.0298|||||||ANCOVA|||P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline number of urgency episodes per 24 hours and baseline weight.||||0.0298
72619494|NCT01557244|144769904|SUPERIORITY|||||||0.1417|||||||ANCOVA|||P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline number of urgency episodes per 24 hours and baseline weight.||||0.1417
72619495|NCT01557244|144769904|SUPERIORITY|||||||0.6219|||||||ANCOVA|||P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline number of urgency episodes per 24 hours and baseline weight.||||0.6219
72619496|NCT01557244|144769904|OTHER||Difference in LS Mean|-0.48|||||TWO_SIDED|95.0|-1.28|0.32||||||||0.32|-1.28|
72619497|NCT01557244|144769904|OTHER||Difference in LS Mean|-0.36|||||TWO_SIDED|95.0|-1.24|0.52||||||||0.52|-1.24|
72619498|NCT01557244|144769905|SUPERIORITY|||||||0.7986|||||||ANCOVA|||P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline mean volume voided per micturition and baseline weight.||||0.7986
72619499|NCT01557244|144769905|SUPERIORITY|||||||0.2313|||||||ANCOVA|||P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline mean volume voided per micturition and baseline weight.||||0.2313
72619500|NCT01557244|144769905|SUPERIORITY|||||||0.7571|||||||ANCOVA|||P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline mean volume voided per micturition and baseline weight.||||0.7571
72619501|NCT01557244|144769905|OTHER||Difference in LS Mean|-0.05|||||TWO_SIDED|95.0|-42.11|42.0||||||||42.00|-42.11|
72619502|NCT01557244|144769905|OTHER||Difference in LS Mean|15.07|||||TWO_SIDED|95.0|-26.5|56.63||||||||56.63|-26.50|
72619503|NCT01557244|144769906|SUPERIORITY|||||||0.061|||||||ANCOVA|||P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline mean volume voided per catheterization and baseline weight.||||0.0610
72619504|NCT01557244|144769906|SUPERIORITY|||||||0.0048|||||||ANCOVA|||P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline mean volume voided per catheterization and baseline weight.||||0.0048
72619505|NCT01557244|144769906|SUPERIORITY|||||||0.01|||||||ANCOVA|||P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline mean volume voided per catheterization and baseline weight.||||0.0100
72619506|NCT01557244|144769906|OTHER||Difference in LS Mean|-16.43|||||TWO_SIDED|95.0|-63.14|30.29||||||||30.29|-63.14|
72619507|NCT01557244|144769906|OTHER||Difference in LS Mean|1.28|||||TWO_SIDED|95.0|-46.0|48.57||||||||48.57|-46.00|
72390736|NCT03982368|144289282|SUPERIORITY||Least square mean difference|16.8||||0.097|TWO_SIDED|95.0|12.3|21.4|||ANOVA|||Daily Activity Limitations - change from baseline to week 8||21.4|12.3|0.097
72390737|NCT03982368|144289282|SUPERIORITY||Least square mean difference|15.3||||0.238|TWO_SIDED|95.0|10.7|19.9|||ANOVA|||Daily Activity Limitations - change from baseline to week 8||19.9|10.7|0.238
72390738|NCT03982368|144289282|SUPERIORITY||Least square mean difference|16.5||||0.07|TWO_SIDED|95.0|12.0|20.9|||ANOVA|||Daily Activity Limitations - change from baseline to week 12||20.9|12.0|0.070
72390739|NCT03982368|144289282|SUPERIORITY||Least square mean difference|16.7||||0.058|TWO_SIDED|95.0|12.3|21.1|||ANOVA|||Daily Activity Limitations - change from baseline to week 12||21.1|12.3|0.058
72390740|NCT03982368|144289282|SUPERIORITY||Least square mean difference|13.7||||0.128|TWO_SIDED|95.0|9.3|18.1|||ANOVA|||Daily Activity Limitations - change from baseline to week 16||18.1|9.3|0.128
72390741|NCT03982368|144289282|SUPERIORITY||Least square mean difference|16.0||||0.024|TWO_SIDED|95.0|11.6|20.3|||ANOVA|||Daily Activity Limitations - change from baseline to week 16||20.3|11.6|0.024
72390742|NCT03982368|144289282|SUPERIORITY||Least square mean difference|15.2||||0.865|TWO_SIDED|95.0|10.4|20.1|||ANOVA|||Emotional Well-Being - change from baseline to week 4||20.1|10.4|0.865
72390743|NCT03982368|144289282|SUPERIORITY||Least square mean difference|17.3||||0.662|TWO_SIDED|95.0|12.4|22.2|||ANOVA|||Emotional Well-Being - change from baseline to week 4||22.2|12.4|0.662
72390744|NCT03982368|144289282|SUPERIORITY||Least square mean difference|16.7||||0.266|TWO_SIDED|95.0|12.2|21.1|||ANOVA|||Emotional Well-Being - change from baseline to week 8||21.1|12.2|0.266
72390745|NCT03982368|144289282|SUPERIORITY||Least square mean difference|13.9||||0.824|TWO_SIDED|95.0|9.4|18.3|||ANOVA|||Emotional Well-Being - change from baseline to week 8||18.3|9.4|0.824
72390746|NCT03982368|144289282|SUPERIORITY||Least square mean difference|14.8||||0.883|TWO_SIDED|95.0|10.6|19.0|||ANOVA|||Emotional Well-Being - change from baseline to week 12||19.0|10.6|0.883
72390747|NCT03982368|144289282|SUPERIORITY||Least square mean difference|16.3||||0.516|TWO_SIDED|95.0|12.1|20.4|||ANOVA|||Emotional Well-Being - change from baseline to week 12||20.4|12.1|0.516
72390748|NCT03982368|144289282|SUPERIORITY|Emotional Well-Being - change from baseline to week 16|Least square mean difference|16.5||||0.407|TWO_SIDED|95.0|12.1|21.0|||ANOVA|||Emotional Well-Being - change from baseline to week 16||21.0|12.1|0.407
72390749|NCT03982368|144289282|SUPERIORITY||Least square mean difference|16.4||||0.422|TWO_SIDED|95.0|12.0|20.9|||ANOVA|||Emotional Well-Being - change from baseline to week 16||20.9|12.0|0.422
72390750|NCT03982368|144289282|SUPERIORITY||Least square mean difference|15.9||||0.615|TWO_SIDED|95.0|8.1|23.8|||ANOVA|||Work Limitations - change from baseline to week 4||23.8|8.1|0.615
72390751|NCT03982368|144289282|SUPERIORITY||Least square mean difference|21.3||||0.626|TWO_SIDED|95.0|13.3|29.2|||ANOVA|||Work Limitations - change from baseline to week 4||29.2|13.3|0.626
72390752|NCT03982368|144289282|SUPERIORITY||Least square mean difference|18.3||||0.968|TWO_SIDED|95.0|11.1|25.6|||ANOVA|||Work Limitations - change from baseline to week 8||25.6|11.1|0.968
72390753|NCT03982368|144289282|SUPERIORITY||Least square mean difference|20.1||||0.689|TWO_SIDED|95.0|12.8|27.4|||ANOVA|||||27.4|12.8|0.689
72390754|NCT03982368|144289282|SUPERIORITY||Least square mean difference|15.6||||0.528|TWO_SIDED|95.0|8.5|22.7|||ANOVA|||Work Limitations - change from baseline to week 12||22.7|8.5|0.528
72390755|NCT03982368|144289282|SUPERIORITY||Least square mean difference|23.0||||0.368|TWO_SIDED|95.0|15.8|30.1|||ANOVA|||Work Limitations - change from baseline to week 12||30.1|15.8|0.368
72390756|NCT03982368|144289282|SUPERIORITY||Least square mean difference|17.7||||0.764|TWO_SIDED|95.0|10.7|24.7|||ANOVA|||Work Limitations - change from baseline to week 16||24.7|10.7|0.764
72390757|NCT03982368|144289282|SUPERIORITY||Least square mean difference|22.6||||0.184|TWO_SIDED|95.0|15.5|29.6|||ANOVA|||Work Limitations - change from baseline to week 16||29.6|15.5|0.184
72390758|NCT03982368|144289282|SUPERIORITY||Least square mean difference|25.4||||0.909|TWO_SIDED|95.0|16.5|34.2|||ANOVA|||Treatment Satisfaction - change from baseline to week 4||34.2|16.5|0.909
72390759|NCT03982368|144289282|SUPERIORITY||Least square mean difference|21.1||||0.428|TWO_SIDED|95.0|12.2|30.0|||ANOVA|||Treatment Satisfaction - change from baseline to week 4||30.0|12.2|0.428
72390760|NCT03982368|144289282|SUPERIORITY||Least square mean difference|29.8||||0.008|TWO_SIDED|95.0|21.6|37.9|||ANOVA|||Treatment Satisfaction - change from baseline to week 8||37.9|21.6|0.008
72390761|NCT03982368|144289282|SUPERIORITY||Least square mean difference|21.3||||0.222|TWO_SIDED|95.0|13.5|29.2|||ANOVA|||Treatment Satisfaction - change from baseline to week 8||29.2|13.5|0.222
72390762|NCT03982368|144289282|SUPERIORITY||Least square mean difference|25.3||||0.082|TWO_SIDED|95.0|17.2|33.4|||ANOVA|||Treatment Satisfaction - change from baseline to week 12||33.4|17.2|0.082
72390763|NCT03982368|144289282|SUPERIORITY||Least square mean difference|23.3||||0.154|TWO_SIDED|95.0|15.6|31.1|||ANOVA|||Treatment Satisfaction - change from baseline to week 12||31.1|15.6|0.154
72390764|NCT03982368|144289282|SUPERIORITY||Least square mean difference|25.8||||0.03|TWO_SIDED|95.0|18.0|33.6|||ANOVA|||Treatment Satisfaction - change from baseline to week 16||33.6|18.0|0.030
72390765|NCT03982368|144289282|SUPERIORITY||Least square mean difference|24.6||||0.046|TWO_SIDED|95.0|17.1|32.1|||ANOVA|||Treatment Satisfaction - change from baseline to week 16||32.1|17.1|0.046
72390766|NCT03982368|144289282|SUPERIORITY||Least square mean difference|15.4||||0.861|TWO_SIDED|95.0|8.6|22.2|||ANOVA|||Treatment-Related Bother - change from baseline to week 4||22.2|8.6|0.861
72390767|NCT03982368|144289282|SUPERIORITY||Least square mean difference|15.3||||0.865|TWO_SIDED|95.0|9.0|21.7|||ANOVA|||Treatment-Related Bother - change from baseline to week 4||21.7|9.0|0.865
72619508|NCT01557244|144769907|SUPERIORITY|||||||0.2246|||||||ANCOVA|||P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline mean volume voided per micturition or catheterization and baseline weight.||||0.2246
72448343|NCT04103580|144414227|SUPERIORITY||Slope|-0.008|STANDARD_ERROR_OF_MEAN|0.004||0.049|TWO_SIDED||||||Mixed Models Analysis|Due to uneven space between time points (days), we estimated a random effects model with varying intercepts and slopes for each phase independently.|We used an interaction between time and study arm to determine whether there was a significant difference over time in the change in outcome. The estimate is the difference in change over time for the intervention group compared to the control group.|The null hypothesis is that there is no difference between control and intervention over time in Phase 2.||||0.049
72498455|NCT03575104|144527458|OTHER|The Type I error rate was controlled for the testing of multiple null hypotheses associated with the endpoint assessed at 1 and 3 months of treatment and the two dose levels studied. Each null hypothesis was tested against the alternative hypothesis that daridorexant improved the endpoint at the given dose and time point compared to placebo. The order of testing and the alpha level applied to each null hypothesis was based on the Bonferroni-based gatekeeping procedure (see SAP for details).|LS mean difference to placebo|-1.25|||=|0.012|TWO_SIDED|95.0|-2.23|-0.276||Mixed effects model for repeated measures: change from baseline in IDSIQ sleepiness domain score = baseline IDSIQ sleepiness domain score + age group (\< 65; ≥ 65 years) + treatment + visit + treatment × visit + baseline × visit.|Mixed Models Analysis|Hypothesis testing result: threshold for significance p = 0.00391; statistically significant = NO||Between-treatment analysis for change from baseline in IDSIQ sleepiness domain score to Month 3 (Daridorexant 25 mg vs placebo).||-0.276|-2.230|= 0.0120
72498456|NCT03575104|144527458|OTHER|The Type I error rate was controlled for the testing of multiple null hypotheses associated with the endpoint assessed at 1 and 3 months of treatment and the two dose levels studied. Each null hypothesis was tested against the alternative hypothesis that daridorexant improved the endpoint at the given dose and time point compared to placebo. The order of testing and the alpha level applied to each null hypothesis was based on the Bonferroni-based gatekeeping procedure (see SAP for details).|LS mean difference to placebo|-0.73|||=|0.1393|TWO_SIDED|95.0|-1.706|0.239||Mixed effects model for repeated measures: change from baseline in IDSIQ sleepiness domain score = baseline IDSIQ sleepiness domain score + age group (\< 65; ≥ 65 years) + treatment + visit + treatment × visit + baseline × visit.|Mixed Models Analysis|Hypothesis testing result: threshold for significance p = 0; statistically significant = NO||Between-treatment analysis for change from baseline in IDSIQ sleepiness domain score to Month 3 (Daridorexant 10 mg vs placebo).||0.239|-1.706|= 0.1393
72390768|NCT03982368|144289282|SUPERIORITY||Least square mean difference|10.5||||0.278|TWO_SIDED|95.0|3.6|17.3|||ANOVA|||Treatment-Related Bother - change from baseline to week 8||17.3|3.6|0.278
72390769|NCT03982368|144289282|SUPERIORITY||Least square mean difference|7.2||||0.689|TWO_SIDED|95.0|0.9|13.5|||ANOVA|||Treatment-Related Bother - change from baseline to week 8||13.5|0.9|0.689
72390770|NCT03982368|144289282|SUPERIORITY||Least square mean difference|9.1||||0.993|TWO_SIDED|95.0|2.1|16.2|||ANOVA|||Treatment-Related Bother - change from baseline to week 12||16.2|2.1|0.993
72390771|NCT03982368|144289282|SUPERIORITY||Least square mean difference|9.2||||0.989|TWO_SIDED|95.0|2.8|15.7|||ANOVA|||Treatment-Related Bother - change from baseline to week 12||15.7|2.8|0.989
72390772|NCT03982368|144289282|SUPERIORITY||Least square mean difference|10.4||||0.976|TWO_SIDED|95.0|3.7|17.0|||ANOVA|||Treatment-Related Bother - change from baseline to week 16||17.0|3.7|0.976
72390773|NCT03982368|144289282|SUPERIORITY||Least square mean difference|9.0||||0.778|TWO_SIDED|95.0|2.9|15.1|||ANOVA|||Treatment-Related Bother - change from baseline to week 16||15.1|2.9|0.778
72390774|NCT03982368|144289282|SUPERIORITY||Least square mean difference|-17.3||||0.964|TWO_SIDED|95.0|-21.2|-13.3|||ANOVA|||Symptom Bother - change from baseline to week 4||-13.3|-21.2|0.964
72390775|NCT03982368|144289282|SUPERIORITY||Least square mean difference|-18.7||||0.581|TWO_SIDED|95.0|-22.7|-14.7|||ANOVA|||Symptom Bother - change from baseline to week 4||-14.7|-22.7|0.581
72390776|NCT03982368|144289282|SUPERIORITY||Least square mean difference|-21.4||||0.006|TWO_SIDED|95.0|-25.2|-17.5|||ANOVA|||Symptom Bother - change from baseline to week 8||-17.5|-25.2|0.006
72390777|NCT03982368|144289282|SUPERIORITY||Least square mean difference|-17.6||||0.175|TWO_SIDED|95.0|-21.4|-13.7|||ANOVA|||Symptom Bother - change from baseline to week 8||-13.7|-21.4|0.175
72390778|NCT03982368|144289282|SUPERIORITY||Least square mean difference|-19.4||||0.016|TWO_SIDED|95.0|-23.1|-15.6|||ANOVA|||Symptom Bother - change from baseline to week 12||-15.6|-23.1|0.016
72390779|NCT03982368|144289282|SUPERIORITY||Least square mean difference|-19.8||||0.01|TWO_SIDED|95.0|-23.5|-16.1|||ANOVA|||Symptom Bother - change from baseline to week 12||-16.1|-23.5|0.010
72390780|NCT03982368|144289282|SUPERIORITY||Least square mean difference|-20.5||||0|TWO_SIDED|95.0|-24.3|-16.8|||ANOVA|||Symptom Bother - change from baseline to week 16||-16.8|-24.3|0.000
72390781|NCT03982368|144289282|SUPERIORITY||Least square mean difference|-20.8||||0|TWO_SIDED|95.0|-24.6|-17.1|||ANOVA|||Symptom Bother - change from baseline to week 16||-17.1|-24.6|0.000
72390782|NCT03982368|144289283|SUPERIORITY|||||||0.302|||||||Wilcoxon (Mann-Whitney)|||at week 4||||0.302
72390783|NCT03982368|144289283|SUPERIORITY|||||||0.224|||||||Wilcoxon (Mann-Whitney)|||at week 4||||0.224
72390784|NCT03982368|144289283|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||at week 8 (FUP)||||0.000
72390785|NCT03982368|144289283|SUPERIORITY|||||||0.885|||||||Wilcoxon (Mann-Whitney)|||at week 8 (FUP)||||0.885
72390786|NCT03982368|144289283|SUPERIORITY|||||||0.035|||||||Wilcoxon (Mann-Whitney)|||At week 12 (FUP)||||0.035
72390787|NCT03982368|144289283|SUPERIORITY|||||||0.698|||||||Wilcoxon (Mann-Whitney)|||At week 12 (FUP)||||0.698
72390788|NCT03982368|144289283|SUPERIORITY|||||||0.016|||||||Wilcoxon (Mann-Whitney)|||At week 16 (FUP)||||0.016
72390789|NCT03982368|144289283|SUPERIORITY|||||||0.706|||||||Wilcoxon (Mann-Whitney)|||At week 16 (FUP)||||0.706
72390790|NCT03982368|144289284|SUPERIORITY|||||||0.21|||||||Wilcoxon (Mann-Whitney)|||at week 4||||0.210
72390791|NCT03982368|144289284|SUPERIORITY|||||||0.26|||||||Wilcoxon (Mann-Whitney)|||at weeek 4||||0.260
72390792|NCT03982368|144289284|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||At week 8 (FUP)||||0.000
72390793|NCT03982368|144289284|SUPERIORITY|||||||0.734|||||||Wilcoxon (Mann-Whitney)|||at week 8 (FUP)||||0.734
72390794|NCT03982368|144289284|SUPERIORITY|||||||0.05|||||||Wilcoxon (Mann-Whitney)|||at week 12 (FUP)||||0.050
72498457|NCT03575104|144527459|OTHER||LS mean difference to placebo|0.93||||0.2506|TWO_SIDED|95.0|0.82|1.05||Mixed effects model for repeated measures: log(value/baseline) = log(baseline) + age group(\< 65; ≥ 65 years) + treatment + visit + treatment x visit + log(baseline) x visit.|Mixed Models Analysis|||Between-treatment analysis for change from baseline in log transformed LPS (min) to Month 1 (Daridorexant 10 mg vs placebo).||1.05|0.82|0.2506
72498458|NCT03575104|144527459|OTHER||LS mean difference to placebo|0.8||||0.0004|TWO_SIDED|95.0|0.71|0.91||Mixed effects model for repeated measures: log(value/baseline) = log(baseline) + age group(\< 65; ≥ 65 years) + treatment + visit + treatment x visit + log(baseline) x visit.|Mixed Models Analysis|||Between-treatment analysis for change from baseline in log transformed LPS (min) to Month 1 (Daridorexant 25 mg vs placebo).||0.91|0.71|0.0004
72498459|NCT03575104|144527460|OTHER||LS mean difference to placebo|0.96||||0.5037|TWO_SIDED|95.0|0.84|1.09||Mixed effects model for repeated measures: log(value/baseline) = log(baseline) + age group(\< 65; ≥ 65 years) + treatment + visit + treatment x visit + log(baseline) x visit.|Mixed Models Analysis|||Between-treatment analysis for change from baseline in log transformed LPS (min) to Month 3 (Daridorexant 10 mg vs placebo).||1.09|0.84|0.5037
72498460|NCT03575104|144527460|OTHER||LS mean difference to placebo|0.81||||0.0021|TWO_SIDED|95.0|0.71|0.93||Mixed effects model for repeated measures: log(value/baseline) = log(baseline) + age group(\< 65; ≥ 65 years) + treatment + visit + treatment x visit + log(baseline) x visit.|Mixed Models Analysis|||Between-treatment analysis for change from baseline in LPS (min) to Month 3 (Daridorexant 25 mg vs placebo).||0.93|0.71|0.0021
72498461|NCT04355013|144527469|OTHER|Agreement between different methods of temperature measurement (Bland-Altman plot with multiple measurements per individual).|Bland-Altman for repeated measures|-0.16|STANDARD_DEVIATION|0.47|||TWO_SIDED|95.0|-1.1|0.77||||||Arterial outlet-nasopharyngeal temperatures||0.77|-1.10|
72498462|NCT04355013|144527469|OTHER|Agreement between different methods of temperature measurement (Bland-Altman plot with multiple measurements per individual).|Mean Difference (Final Values)|0.16|STANDARD_DEVIATION|0.4|||TWO_SIDED|95.0|-0.63|0.95|||Bland-Altman|||Arterial-venous inflow temperatures||0.95|-0.63|
72619509|NCT01557244|144769907|SUPERIORITY|||||||0.0003|||||||ANCOVA|||P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline mean volume voided per micturition or catheterization and baseline weight.||||0.0003
72390795|NCT03982368|144289284|SUPERIORITY|||||||0.985|||||||Wilcoxon (Mann-Whitney)|||at week 12 (FUP)||||0.985
72390796|NCT03982368|144289284|SUPERIORITY|||||||0.018|||||||Wilcoxon (Mann-Whitney)|||at week 16 (FUP)||||0.018
72390797|NCT03982368|144289284|SUPERIORITY|||||||0.58|||||||Wilcoxon (Mann-Whitney)|||at week 16 (FUP)||||0.580
72390798|NCT03982368|144289285|SUPERIORITY||Least square mean difference|1.2||||0.282|TWO_SIDED|95.0|-1.0|3.3|||ANOVA|||statistical analysis at week 4||3.3|-1.0|0.282
72390799|NCT03982368|144289285|SUPERIORITY||Least square mean difference|3.9||||0.497|TWO_SIDED|95.0|1.7|6.0|||ANOVA|||statistical analysis at week 4||6.0|1.7|0.497
72390800|NCT03982368|144289285|SUPERIORITY||Least square mean difference|2.6||||0.734|TWO_SIDED|95.0|0.5|4.8|||ANOVA|||statistical analysis at week 8||4.8|0.5|0.734
72390801|NCT03982368|144289285|SUPERIORITY||Least square mean difference|2.2||||0.963|TWO_SIDED|95.0|0.1|4.3|||ANOVA|||statistical analysis at week 8||4.3|0.1|0.963
72390802|NCT03982368|144289285|SUPERIORITY||Least square mean difference|2.7||||0.854|TWO_SIDED|95.0|0.7|4.8|||ANOVA|||statistical analysis at week 12||4.8|0.7|0.854
72390803|NCT03982368|144289285|SUPERIORITY||Least square mean difference|2.8||||0.881|TWO_SIDED|95.0|0.8|4.8|||ANOVA|||statistical analysis at week 12||4.8|0.8|0.881
72390804|NCT03982368|144289285|SUPERIORITY||Least square mean difference|3.0||||0.632|TWO_SIDED|95.0|0.3|5.7|||ANOVA|||statistical analysis at week 16||5.7|0.3|0.632
72390805|NCT03982368|144289285|SUPERIORITY||Least square mean difference|4.4||||0.22|TWO_SIDED|95.0|1.7|7.0|||ANOVA|||statistical analysis at week 16||7.0|1.7|0.220
72390806|NCT03982368|144289286|SUPERIORITY||Least square mean difference|1.2||||0.296|TWO_SIDED|95.0|-0.9|3.3|||ANOVA|||statistical analysis at week 4||3.3|-0.9|0.296
72390807|NCT03982368|144289286|SUPERIORITY||Least square mean difference|3.6||||0.57|TWO_SIDED|95.0|1.5|5.7|||ANOVA|||statistical analysis at week 4||5.7|1.5|0.570
72390808|NCT03982368|144289286|SUPERIORITY||Least square mean difference|2.7||||0.754|TWO_SIDED|95.0|0.5|4.9|||ANOVA|||statistical analysis at week 8||4.9|0.5|0.754
72390809|NCT03982368|144289286|SUPERIORITY||Least square mean difference|2.3||||0.972|TWO_SIDED|95.0|0.0|4.5|||ANOVA|||statistical analysis at week 8||4.5|0.0|0.972
72390810|NCT03982368|144289286|SUPERIORITY||Least square mean difference|3.4||||0.793|TWO_SIDED|95.0|1.4|5.3|||ANOVA|||statistical analysis at week 12||5.3|1.4|0.793
72390811|NCT03982368|144289286|SUPERIORITY||Least square mean difference|3.4||||0.766|TWO_SIDED|95.0|1.5|5.3|||ANOVA|||statistical analysis at week 12||5.3|1.5|0.766
72390812|NCT03982368|144289286|SUPERIORITY||Least square mean difference|3.3||||0.458|TWO_SIDED|95.0|0.6|6.0|||ANOVA|||statistical analysis at week 16||6.0|0.6|0.458
72390813|NCT03982368|144289286|SUPERIORITY||Least square mean difference|4.6||||0.147|TWO_SIDED|95.0|2.0|7.3|||ANOVA|||statistical analysis at week 16||7.3|2.0|0.147
72390814|NCT00329238|144289287|NON_INFERIORITY_OR_EQUIVALENCE|Comparisons between treatment groups were performed using a Cox regression analysis with treatment and baseline stratification factor in the model.|Hazard Ratio (HR)|1.44||||0.0137||95.0|0.78|2.64||p-value for non-inferiority. The non-inferiority margin for the hazard ratio was chosen to be 2.85.|Regression, Cox|HR within cohort estimated by Cox regr. with treatment and baseline stratific. factor. Overall HR calc. by pooling with inverse variance weighting.|HR for time to first recurrent VTE or VTE death.|||2.64|0.78|0.0137
72390815|NCT00329238|144289287|SUPERIORITY_OR_OTHER|||||||0.2424||||||p-value for superiority. If non-inferiority could be established for HR and for the risk difference, the upper bound of the 95% CI for the hazard ratio was then compared with 1 to evaluate the superiority claim of dabigatran over warfarin.|Regression, Cox|||||||0.2424
72390816|NCT00329238|144289288|NON_INFERIORITY_OR_EQUIVALENCE|Comparisons between treatment groups were performed using a Cox regression analysis with treatment and baseline stratification factor in the model.|Risk Difference (RD)|0.38|||<|0.0001||95.0|-0.5|1.25||p-value for non-inferiority. The non-inferiority margin for the risk difference was chosen to be 2.80.|Regression, Cox|Risk difference for time to first recurrent VTE/VTE death is calculated based on weighted KM estimates across the cohorts via meta-analysis approach.||||1.25|-0.50|<0.0001
72448344|NCT04103580|144414228|SUPERIORITY||Slope|0.006|STANDARD_ERROR_OF_MEAN|0.004||0.15|TWO_SIDED||||||Mixed Models Analysis|Due to uneven space between time points (days), we estimated a random effects model with varying intercepts and slopes for each phase independently.|We used an interaction between time and study arm to determine whether there was a significant difference over time in the change in outcome. The estimate is the difference in change over time for the intervention group compared to the control group.|The null hypothesis is that there is no difference between control and intervention over time in Phase 1.||||0.150
72448345|NCT04103580|144414228|SUPERIORITY||Slope|-0.002|STANDARD_ERROR_OF_MEAN|0.004||0.635|TWO_SIDED||||||Mixed Models Analysis|Due to uneven space between time points (days), we estimated a random effects model with varying intercepts and slopes for each phase independently.|We used an interaction between time and study arm to determine whether there was a significant difference over time in the change in outcome. The estimate is the difference in change over time for the intervention group compared to the control group.|The null hypothesis is that there is no difference between control and intervention over time in Phase 2.||||0.635
72448346|NCT00104676|144414238|SUPERIORITY||Hazard Ratio (HR)|0.66||||0.05|TWO_SIDED|95.0|0.44|1.0|||Log Rank|Adjusted on the stratification factor (treatment centers)||To detect an absolute difference of 20% in progression-free survival at 3-years between Arm I and Unfav-Dose-Dense Arm II (46% versus 66%) with the possibility that 80 events (progressive disease and death) may be observed during this period, a total of 196 participants, 98 per group needed to be included, with an additional 25% of patients for a total of 260 participants required.||1.00|0.44|0.05
72448347|NCT00104676|144414239|SUPERIORITY||Hazard Ratio (HR)|0.78||||0.34|TWO_SIDED|95.0|0.46|1.31|||Log Rank|Adjusted on the stratification factor (treatment centers)||||1.31|0.46|0.34
72448348|NCT04324359|144414280|SUPERIORITY||||||<|0.001|||||||z-test for proportions|Other: z-test for proportions, 2-sided test at alpha = 5% level. P-value: based on the normal approximation test for differences between proportions.||||||<0.001
72448349|NCT04324359|144414281|SUPERIORITY|||||||0.066|||||||Other: z-test for proportions|Other: z-test for proportions, 2-sided test at alpha = 5% level. P-value: based on Barnard's exact test for differences between proportions.||||||0.066
72448350|NCT04324359|144414282|SUPERIORITY|||||||0.716|||||||z-test for proportions|Other: z-test for proportions, 2-sided test at alpha = 5% level. P-value: based on Barnard's exact test for differences between proportions.||||||0.716
72448351|NCT04324359|144414283|SUPERIORITY|||||||0.528|||||||z-test for proportions|Other: z-test for proportions, 2-sided test at alpha = 5% level P-value: based on Barnard's exact test for differences between proportions.||||||0.528
72619510|NCT01557244|144769907|SUPERIORITY|||||||0.0161|||||||ANCOVA|||P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline mean volume voided per micturition or catheterization and baseline weight.||||0.0161
72448352|NCT04324359|144414284|SUPERIORITY|||||||0.766|||||||z-test for proportions|Other: z-test for proportions, 2-sided test at alpha = 5% level. P-value: based on Barnard's exact test for differences between proportions.||||||0.766
72448353|NCT04324359|144414285|SUPERIORITY|||||||0.619|||||||z-test for proportions|Other: z-test for proportions, 2-sided test at alpha = 5% level. P-value: based on Barnard's exact test for differences between proportions.||||||0.619
72448354|NCT03899259|144414286|SUPERIORITY||Odds Ratio (OR)|7.86|||<|0.001|TWO_SIDED|95.0|2.79|22.17|||Regression, Logistic|||||22.17|2.79|<0.001
72498463|NCT04355013|144527469|OTHER|Agreement between different methods of temperature measurement (Bland-Altman plot with multiple measurements per individual).|Mean Difference (Final Values)|-0.62|STANDARD_DEVIATION|0.69|||TWO_SIDED|95.0|-1.98|0.74|||Bland-Altman|||Arterial outlet-bladder||0.74|-1.98|
72619511|NCT01557244|144769907|OTHER||Difference in LS Mean|-18.24|||||TWO_SIDED|95.0|-61.0|24.53||||||||24.53|-61.00|
72619512|NCT01557244|144769907|OTHER||Difference in LS Mean|18.86|||||TWO_SIDED|95.0|-22.93|60.65||||||||60.65|-22.93|
72448355|NCT03899259|144414286|SUPERIORITY||Odds Ratio (OR)|19.72|||<|0.001|TWO_SIDED|95.0|7.3|53.3|||Regression, Logistic|||||53.30|7.30|<0.001
72448356|NCT03899259|144414287|SUPERIORITY||Mean Difference (Final Values)|-25.25|STANDARD_ERROR_OF_MEAN|3.834|<|0.001|TWO_SIDED|95.0|-32.78|-17.72|||ANCOVA|||||-17.72|-32.78|<0.001
72448357|NCT03899259|144414287|SUPERIORITY||Mean Difference (Final Values)|-44.49|STANDARD_ERROR_OF_MEAN|3.482|<|0.001|TWO_SIDED|95.0|-51.33|-37.65|||ANCOVA|||||-37.65|-51.33|<0.001
72448358|NCT03899259|144414288|SUPERIORITY||Odds Ratio (OR)|4.63||||0.005|TWO_SIDED|95.0|1.58|13.6|||Regression, Logistic|||||13.60|1.58|0.005
72448359|NCT03899259|144414288|SUPERIORITY||Odds Ratio (OR)|12.94|||<|0.001|TWO_SIDED|95.0|4.72|35.44|||Regression, Logistic|||||35.44|4.72|<0.001
72448360|NCT03899259|144414289|SUPERIORITY||Odds Ratio (OR)|4.36||||0.001|TWO_SIDED|95.0|1.77|10.74|||Regression, Logistic|||||10.74|1.77|0.001
72448361|NCT03899259|144414289|SUPERIORITY||Odds Ratio (OR)|13.37|||<|0.001|TWO_SIDED|95.0|5.75|31.1|||Regression, Logistic|||||31.10|5.75|<0.001
72448362|NCT03899259|144414291|SUPERIORITY||Odds Ratio (OR)|2.56||||0.076|TWO_SIDED|95.0|0.91|7.24|||Regression, Logistic|||||7.24|0.91|0.076
72448363|NCT03899259|144414291|SUPERIORITY||Odds Ratio (OR)|10.3|||<|0.001|TWO_SIDED|95.0|4.12|25.77|||Regression, Logistic|||||25.77|4.12|<0.001
72448364|NCT03899259|144414292|SUPERIORITY||Odds Ratio (OR)|1.88||||0.26|TWO_SIDED|95.0|0.63|5.62|||Regression, Logistic|||||5.62|0.63|0.260
72448365|NCT03899259|144414292|SUPERIORITY||Odds Ratio (OR)|8.1|||<|0.001|TWO_SIDED|95.0|3.18|20.66|||Regression, Logistic|||||20.66|3.18|<0.001
72448366|NCT03899259|144414293|SUPERIORITY||Odds Ratio (OR)|3.43||||0.017|TWO_SIDED|95.0|1.25|9.4|||Regression, Logistic|||||9.40|1.25|0.017
72448367|NCT03899259|144414293|SUPERIORITY||Odds Ratio (OR)|10.85|||<|0.001|TWO_SIDED|95.0|4.32|27.25|||Regression, Logistic|||||27.25|4.32|<0.001
72448368|NCT03899259|144414294|SUPERIORITY||Odds Ratio (OR)|14.63||||0.002|TWO_SIDED|95.0|2.73|78.42|||Regression, Logistic|||||78.42|2.73|0.002
72448369|NCT03899259|144414294|SUPERIORITY||Odds Ratio (OR)|30.37|||<|0.001|TWO_SIDED|95.0|5.93|99.99|||Regression, Logistic|||||99.99|5.93|<0.001
72448370|NCT03899259|144414295|SUPERIORITY||Mean Difference (Final Values)|-3.02|STANDARD_ERROR_OF_MEAN|1.981||0.129|TWO_SIDED|95.0|-6.91|0.88|||ANCOVA|||||0.88|-6.91|0.129
72619513|NCT01313676|144769943|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.878||||0.137|TWO_SIDED|95.0|0.739|1.042|||Cox Proportional Hazards Model|||||1.042|0.739|0.137
72448371|NCT03899259|144414295|SUPERIORITY||Mean Difference (Final Values)|-4.21|STANDARD_ERROR_OF_MEAN|1.799||0.02|TWO_SIDED|95.0|-7.75|-0.68|||ANCOVA|||||-0.68|-7.75|0.020
72448372|NCT03899259|144414296|SUPERIORITY||Mean Difference (Final Values)|-6.75|STANDARD_ERROR_OF_MEAN|3.017||0.026|TWO_SIDED|95.0|-12.68|-0.82|||ANCOVA|||||-0.82|-12.68|0.026
72448373|NCT03899259|144414296|SUPERIORITY||Mean Difference (Final Values)|-13.42|STANDARD_ERROR_OF_MEAN|2.737|<|0.001|TWO_SIDED|95.0|-18.8|-8.04|||ANCOVA|||||-8.04|-18.80|<0.001
72448374|NCT03899259|144414297|SUPERIORITY||Mean Difference (Final Values)|-4.38|STANDARD_ERROR_OF_MEAN|2.68||0.103|TWO_SIDED|95.0|-9.65|0.88|||ANCOVA|||||0.88|-9.65|0.103
72448375|NCT03899259|144414297|SUPERIORITY||Mean Difference (Final Values)|-8.33|STANDARD_ERROR_OF_MEAN|2.429|<|0.001|TWO_SIDED|95.0|-13.1|-3.56|||ANCOVA|||||-3.56|-13.10|<0.001
72448376|NCT03899259|144414298|SUPERIORITY||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.315||0.518|TWO_SIDED|95.0|-0.82|0.42|||ANCOVA|||||0.42|-0.82|0.518
72448377|NCT03899259|144414298|SUPERIORITY||Mean Difference (Final Values)|-0.72|STANDARD_ERROR_OF_MEAN|0.286||0.012|TWO_SIDED|95.0|-1.28|-0.16|||ANCOVA|||||-0.16|-1.28|0.012
72448378|NCT03899259|144414299|SUPERIORITY||Mean Difference (Final Values)|-0.51|STANDARD_ERROR_OF_MEAN|0.291||0.083|TWO_SIDED|95.0|-1.08|0.07|||ANCOVA|||||0.07|-1.08|0.083
72448379|NCT03899259|144414299|SUPERIORITY||Mean Difference (Final Values)|-0.68|STANDARD_ERROR_OF_MEAN|0.264||0.01|TWO_SIDED|95.0|-1.2|-0.16|||ANCOVA|||||-0.16|-1.20|0.010
72448380|NCT05670587|144414301|OTHER||gMean ratio at Week 4|0.95|||||TWO_SIDED|95.0|0.76|1.18|||||"gMean ratios of CfB in CC/h were calculated from the log transformed values at each visit.~Geometric Coefficient of variation (gCV) = 84.59%"|Geometric mean (gMean) ratio of change from baseline (CfB) in cough count per hour (CC/h) at Week 4.||1.18|0.76|
72448381|NCT05670587|144414301|OTHER||gMean ratio at Week 8|0.84|||||TWO_SIDED|95.0|0.64|1.11|||||"gMean ratios of CfB in CC/h were calculated from the log transformed values at each visit.~Geometric coefficient of variation (gCV) = 115.62%"|Geometric mean (gMean) ratio of change from baseline (CfB) in cough count per hour (CC/h) at Week 8.||1.11|0.64|
72448382|NCT05670587|144414301|OTHER||gMean ratio at Day 82|0.98|||||TWO_SIDED|95.0|0.75|1.29|||||"gMean ratios of CfB in CC/h were calculated from the log transformed values at each visit.~Geometric coefficient of variation (gCV) = 100.02%."|Geometric mean (gMean) ratio of change from baseline (CfB) in cough count per hour (CC/h) at Day 82.||1.29|0.75|
72448383|NCT05139810|144414309|SUPERIORITY||IC HAE attack rate ratio|0.19|||<|0.001|TWO_SIDED|95.0|0.107|0.351|||Poisson regression model||Model adjusted rate ratio from Poisson regression model.|The Poisson regression model includes treatment groups, baseline (the run-in period HAE attack rate), the treatment-by-baseline interaction as a covariate, and the logarithm of time in every-4-week that each participant was observed from Week 1 to Week 25 used as an offset variable. Pearson chi-square scaling of standard errors was used to account for potential over dispersion.||0.351|0.107|<0.001
72448384|NCT05139810|144414309|SUPERIORITY||IC HAE attack rate ratio|0.45|||=|0.004|TWO_SIDED|95.0|0.261|0.777|||Poisson regression model||Model adjusted rate ratio from Poisson regression model.|The Poisson regression model includes treatment groups, baseline (the run-in period HAE attack rate), the treatment-by-baseline interaction as a covariate, and the logarithm of time in every-4-week that each participant was observed from Week 1 to Week 25 used as an offset variable. Pearson chi-square scaling of standard errors was used in the Poisson regression model to account for potential overdispersion.||0.777|0.261|=0.004
72448385|NCT05139810|144414310|SUPERIORITY||IC HAE attack rate ratio|0.13|||<|0.001|TWO_SIDED|95.0|0.062|0.281|||Poisson regression model||Model adjusted rate ratio from Poisson regression model.|The Poisson regression model includes treatment groups, baseline (the run-in period HAE attack rate), the treatment-by-baseline interaction as a covariate, and the logarithm of time in every-4-week that each participant was observed from Week 5 to Week 25 used as an offset variable. Pearson chi-square scaling of standard errors was used in the Poisson regression model to account for potential over dispersion.||0.281|0.062|<0.001
72448386|NCT05139810|144414310|SUPERIORITY||IC HAE attack rate ratio|0.4|||=|0.004|TWO_SIDED|95.0|0.212|0.748|||Poisson regression model||Model adjusted rate ratio from Poisson regression model.|The Poisson regression model includes treatment groups, baseline (the run-in period HAE attack rate), the treatment-by-baseline interaction as a covariate, and the logarithm of time in every-4-week that each participant was observed from Week 5 to Week 25 used as an offset variable. Pearson chi-square scaling of standard errors was used in the Poisson regression model to account for potential over dispersion.||0.748|0.212|=0.004
72448387|NCT05139810|144414311|SUPERIORITY||Odds Ratio (OR)|11.79|||=|0.003|TWO_SIDED|95.0|2.34|59.36|||Regression, Logistic|p-value was calculated based on logistic regression with baseline and the treatment-by-baseline interaction as a covariate.||||59.36|2.34|=0.003
72448388|NCT05139810|144414311|SUPERIORITY||Odds Ratio (OR)|3.23|||=|0.24|TWO_SIDED|95.0|0.46|22.85|||Regression, Logistic|p-value was calculated based on logistic regression with baseline and the treatment-by-baseline interaction as a covariate.||||22.85|0.46|=0.240
72448389|NCT05139810|144414312|SUPERIORITY||IC HAE attack rate ratio|0.11|||<|0.001|TWO_SIDED|95.0|0.035|0.339|||Poisson regression model||Model adjusted rate ratio from Poisson regression model.|The Poisson regression model includes treatment groups, baseline (the run-in period HAE attack rate), the treatment-by-baseline interaction as a covariate, and the logarithm of time in every-4-week that each participant was observed from Week 5 to Week 25 used as an offset variable. Pearson chi-square scaling of standard errors was used in the Poisson regression model to account for potential over dispersion.||0.339|0.035|<0.001
72448390|NCT05139810|144414312|SUPERIORITY||IC HAE attack rate ratio|0.59|||=|0.173|TWO_SIDED|95.0|0.276|1.26|||Poisson regression model||Model adjusted rate ratio from Poisson regression model.|The Poisson regression model includes treatment groups, baseline (the run-in period HAE attack rate), the treatment-by-baseline interaction as a covariate, and the logarithm of time in every-4-week that each participant was observed from Week 5 to Week 25 used as an offset variable. Pearson chi-square scaling of standard errors was used in the Poisson regression model to account for potential over dispersion.||1.260|0.276|=0.173
72448391|NCT05139810|144414313|SUPERIORITY||Odds Ratio (OR)|310.35|||<|0.001|TWO_SIDED|95.0|11.63|8279.94|||Regression, Logistic|p-value was calculated based on logistic regression with baseline and the treatment-by-baseline interaction as a covariate.|The odds ratio and its 95% confidence interval were calculated based on a logistic regression with baseline (the time-normalized run-in period attack rate) and the treatment-by-baseline interaction as a covariate.|≥ 50% Reduction||8279.94|11.63|<0.001
72448392|NCT05139810|144414313|SUPERIORITY||Odds Ratio (OR)|14.8|||<|0.001|TWO_SIDED|95.0|3.15|69.41|||Regression, Logistic|p-value was calculated based on logistic regression with baseline and the treatment-by-baseline interaction as a covariate.|The odds ratio and its 95% confidence interval were calculated based on a logistic regression with baseline (the time-normalized run-in period attack rate) and the treatment-by-baseline interaction as a covariate.|≥ 50% Reduction||69.41|3.15|<0.001
72448393|NCT05139810|144414313|SUPERIORITY||Odds Ratio (OR)|34.74|||<|0.001|TWO_SIDED|95.0|7.32|164.87|||Regression, Logistic|p-value was calculated based on logistic regression with baseline and the treatment-by-baseline interaction as a covariate.|The odds ratio and its 95% confidence interval were calculated based on a logistic regression with baseline (the time-normalized run-in period attack rate) and the treatment-by-baseline interaction as a covariate.|≥ 70% Reduction||164.87|7.32|<0.001
72448394|NCT05139810|144414313|SUPERIORITY||Odds Ratio (OR)|9.17|||=|0.004|TWO_SIDED|95.0|2.05|41.09|||Regression, Logistic|p-value was calculated based on logistic regression with baseline and the treatment-by-baseline interaction as a covariate.|The odds ratio and its 95% confidence interval were calculated based on a logistic regression with baseline (the time-normalized run-in period attack rate) and the treatment-by-baseline interaction as a covariate.|≥ 70% Reduction||41.09|2.05|=0.004
72448395|NCT05139810|144414313|SUPERIORITY||Odds Ratio (OR)|17.04|||<|0.001|TWO_SIDED|95.0|3.36|86.42|||Regression, Logistic|p-value was calculated based on logistic regression with baseline and the treatment-by-baseline interaction as a covariate.|The odds ratio and its 95% confidence interval were calculated based on a logistic regression with baseline (the time-normalized run-in period attack rate) and the treatment-by-baseline interaction as a covariate.|≥ 90% Reduction||86.42|3.36|<0.001
72448396|NCT05139810|144414313|SUPERIORITY||Odds Ratio (OR)|8.7|||=|0.014|TWO_SIDED|95.0|1.56|48.52|||Regression, Logistic|p-value was calculated based on logistic regression with baseline and the treatment-by-baseline interaction as a covariate.|The odds ratio and its 95% confidence interval were calculated based on a logistic regression with baseline (the time-normalized run-in period attack rate) and the treatment-by-baseline interaction as a covariate.|≥ 90% Reduction||48.52|1.56|=0.014
72448397|NCT05139810|144414314|SUPERIORITY||IC HAE attack rate ratio|0.08|||<|0.001|TWO_SIDED|95.0|0.03|0.234|||Poisson regression model||Model adjusted rate ratio from Poisson regression model.|The Poisson regression model includes treatment groups, baseline (the run-in period HAE attack rate), the treatment-by-baseline interaction as a covariate, and the logarithm of time in every-4-week that each participant was observed from Week 5 to Week 25 used as an offset variable. Pearson chi-square scaling of standard errors was used in the Poisson regression model to account for potential over dispersion.||0.234|0.030|<0.001
72448398|NCT05139810|144414314|SUPERIORITY||IC HAE attack rate ratio|0.33|||=|0.004|TWO_SIDED|95.0|0.155|0.706|||Poisson regression model||Model adjusted rate ratio from Poisson regression model.|The Poisson regression model includes treatment groups, baseline (the run-in period HAE attack rate), the treatment-by-baseline interaction as a covariate, and the logarithm of time in every-4-week that each participant was observed from Week 5 to Week 25 used as an offset variable. Pearson chi-square scaling of standard errors was used in the Poisson regression model to account for potential over dispersion.||0.706|0.155|=0.004
72498464|NCT04355013|144527469|OTHER|Agreement between different methods of temperature measurement (Bland-Altman plot with multiple measurements per individual).|Mean Difference (Final Values)|0.08|STANDARD_DEVIATION|0.74|||TWO_SIDED|95.0|-1.38|1.54|||Bland-Altman|||Arterial outlet- Tcore||1.54|-1.38|
72619514|NCT01313676|144769943|SUPERIORITY_OR_OTHER||Percent reduction in risk of death|12.2|||||TWO_SIDED|95.0|-4.2|26.1|||||Confidence Interval (95%) and Estimated Value is presented for the percent reduction in risk of death at any time up to or on the CED, calculated as (1-hazard ratio)\*100|||26.1|-4.2|
72448399|NCT05139810|144414316|SUPERIORITY||Treatment difference|-18.56|||<|0.001|TWO_SIDED|95.0|-27.673|-9.454|||Mixed model with repeated measures(MMRM)|||||-9.454|-27.673|<0.001
72448400|NCT05139810|144414316|SUPERIORITY||Treatment difference|-13.65|||=|0.01|TWO_SIDED|95.0|-24.024|-3.286|||MMRM|||||-3.286|-24.024|=0.010
72498465|NCT04355013|144527469|OTHER|Agreement between different methods of temperature measurement (Bland-Altman plot with multiple measurements per individual).|Mean Difference (Final Values)|0.32|STANDARD_DEVIATION|0.53|||TWO_SIDED|95.0|-0.73|1.38||||||Nasopharyngeal-venous inflow temperatures||1.38|-0.73|
72448401|NCT06182033|144414317|OTHER|||||||0.84|||||||Regression, Linear|Kenward Rogers and Restricted Maximum Likelihood adjustment made to reduce error likelihood||We conducted a linear regression. We accounted for baseline, which allowed us to examine residualized gains. We controlled for age.||||.84
72448402|NCT06182033|144414318|OTHER|||||||0.727|||||||Regression, Linear|Kenward Rogers and Restricted Maximum Likelihood adjustment made to reduce error likelihood||We conducted a linear regression. We accounted for baseline, which allowed us to examine residualized gains. We controlled for age.||||.727
72448403|NCT06182033|144414319|OTHER|||||||0.205|||||||Regression, Linear|Kenward Rogers and Restricted Maximum Likelihood adjustment made to reduce error likelihood||These analyses use the assertiveness subscale as the outcome variable. We conducted a linear regression for each of the measure's subscales. We accounted for baseline, which allowed us to examine residualized gains. We controlled for age.||||.205
72448404|NCT06182033|144414319|OTHER|||||||0.034|||||||Regression, Linear|Kenward Rogers and Restricted Maximum Likelihood adjustment made to reduce error likelihood||This analysis focused specifically on the behavior control subscale. We conducted a linear regression for each of the measure's subscales. We accounted for baseline, which allowed us to examine residualized gains. We controlled for age.||||.034
72448405|NCT06182033|144414319|OTHER|||||||0.099|||||||Regression, Linear|Kenward Rogers and Restricted Maximum Likelihood adjustment made to reduce error likelihood||These analyses use the Task Orientation subscale as the outcome variable. We conducted a linear regression for each of the measure's subscales. We accounted for baseline, which allowed us to examine residualized gains. We controlled for age.||||.099
72448406|NCT06182033|144414319|OTHER|||||||0.209|||||||Regression, Linear|||This analysis used peer social skills subscale as the outcome in the model. We conducted a linear regression for each of the measure's subscales. We accounted for baseline, which allowed us to examine residualized gains. We controlled for age.||||.209
72498466|NCT04355013|144527469|OTHER|Agreement between different methods of temperature measurement (Bland-Altman plot with multiple measurements per individual).|Mean Difference (Final Values)|-0.46|STANDARD_DEVIATION|0.52|||TWO_SIDED|95.0|-1.5|0.59||||||Nasopharyngeal-bladder temperatures||0.59|-1.50|
72619515|NCT01313676|144769943|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.911||||0.284|TWO_SIDED|95.0|0.767|1.081|||Cox Proportional Hazards Model|||||1.081|0.767|0.284
72390817|NCT00329238|144289288|SUPERIORITY_OR_OTHER|||||||0.4013||||||p-value for superiority. If non-inferiority could be established for HR and for the risk difference, the upper bound of the 95% CI for the risk difference was then compared with 0 to evaluate the superiority claim of dabigatran over warfarin.|Kaplan-Meier|||||||0.4013
72390818|NCT00329238|144289289|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.18||||0.4732||95.0|0.75|1.84|||Regression, Cox|Hazard ratio estimated using the Cox regression with treatment, cohort, baseline stratification factors and their interaction.|HR for time to first centrally adjudicated recurrent VTE or all cause death.|||1.84|0.75|0.4732
72390819|NCT00329238|144289290|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.09||||0.8876||95.0|-1.11|1.28|||Kaplan-Meier|Risk difference for the time to first centrally adjudicated recurrent VTE or all cause death at month 18.||Dabigatran versus Warfarin||1.28|-1.11|0.8876
72390820|NCT00329238|144289291|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.32||||0.4548||95.0|0.64|2.71|||Regression, Cox|Hazard ratio estimated using the Cox regression with treatment, cohort, baseline stratification factors and their interaction.|HR for time to first centrally adjudicated recurrent symptomatic DVT|Dabigatran versus Warfarin||2.71|0.64|0.4548
72390821|NCT00329238|144289292|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.19||||0.6563||95.0|-0.63|1.0|||Kaplan-Meier|Risk difference for the time to first centrally adjudicated recurrent symptomatic DVT at Month 18.||Dabigatran versus Warfarin||1.00|-0.63|0.6563
72390822|NCT00329238|144289293|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.04||||0.1925||95.0|0.7|5.98|||Regression, Cox|Hazard ratio estimated using the Cox regression with treatment, cohort, baseline stratification factors and their interaction.|Hazard ratio for time to first centrally adjudicated recurrent symptomatic PE.|Dabigatran versus Warfarin||5.98|0.70|0.1925
72390823|NCT00329238|144289294|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.26||||0.3723||95.0|-0.32|0.84|||Kaplan-Meier||Risk difference for the time to first centrally adjudicated recurrent symptomatic PE at Month 18|Dabigatran versus Warfarin||0.84|-0.32|0.3723
72390824|NCT00329238|144289295|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.01||||0.9921||95.0|0.06|16.22|||Regression, Cox|Hazard ratio estimated using the Cox regression with treatment, cohort, baseline stratification factors and their interaction.|Hazard ratio for time to deaths related to VTE.|Dabigatran versus Warfarin||16.22|0.06|0.9921
72390825|NCT00329238|144289296|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.01||||0.9204||95.0|-0.2|0.23|||Kaplan-Meier|Risk difference for the time to deaths related to VTE at Month 18.||Dabigatran versus Warfarin||0.23|-0.20|0.9204
72390826|NCT00329238|144289297|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.9||||0.7405||95.0|0.47|1.72|||Regression, Cox|Hazard ratio estimated using the Cox regression with treatment, cohort, baseline stratification factors and their interaction.|Hazard ratio for time to all deaths|Dabigatran versus Warfarin||1.72|0.47|0.7405
72390827|NCT00329238|144289298|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.02||||0.9622||95.0|-0.89|0.84|||Kaplan-Meier|Risk difference for the time to all deaths at Month 18.||Dabigatran versus Warfarin||0.84|-0.89|0.9622
72390828|NCT00329238|144289299|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.52||||0.0577||95.0|0.27|1.02|||Regression, Cox||This is the analysis of the time to the first MBE.|Hazard ratio estimated using the Cox regression with treatment, cohort, baseline stratification factors (including active cancer at baseline and symptomatic PE as qualifying event) and their interaction.||1.02|0.27|0.0577
72390829|NCT00329238|144289299|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.71|||<|0.0001|TWO_SIDED|95.0|0.61|0.83|||Regression, Cox||This is the analysis of the time to the first occurrence of any bleeding event.|Hazard ratio estimated using the Cox regression with treatment, cohort, baseline stratification factors (including active cancer at baseline and symptomatic PE as qualifying event) and their interaction.||0.83|0.61|<0.0001
72390830|NCT03652012|144289303|SUPERIORITY||Mean Difference (Final Values)|54.2||||0.044|TWO_SIDED|95.0|1.54|106.85||As multiple parameters were assessed from the stimulus-response curve, a Bonferroni-adjusted alpha threshold of α = 0.0125 was applied to account for multiple comparisons when assessing this outcome measure.|ANOVA||Mean difference (Healthy Controls - MCI).|"We conducted a two-way factorial ANOVA (Group x Condition). Group has two levels: MCI and Healthy controls. Condition has two levels: active muscle contraction and rest.~As multiple parameters were assessed from the stimulus-response curve, a Bonferroni-adjusted alpha threshold of α = 0.0125 was applied to account for multiple comparisons when assessing this outcome measure."||106.85|1.54|0.044
72390831|NCT03652012|144289303|SUPERIORITY||Mean Difference (Final Values)|2.8||||0.912|TWO_SIDED|95.0|-51.87|57.47||As multiple parameters were assessed from the stimulus-response curve, a Bonferroni-adjusted alpha threshold of α = 0.0125 was applied to account for multiple comparisons when assessing this outcome measure.|ANOVA||Mean difference in slope of the stimulus-response curve by muscle contraction condition (Active - Rest).|"We conducted a two-way factorial ANOVA (Group x Condition). Group has two levels: MCI and Healthy controls. Condition has two levels: active muscle contraction and rest.~As multiple parameters were assessed from the stimulus-response curve, a Bonferroni-adjusted alpha threshold of α = 0.0125 was applied to account for multiple comparisons when assessing this outcome measure.~The results presented here reflect the main effect of Condition on the slope of the stimulus-response curve."||57.47|-51.87|0.912
72390832|NCT03652012|144289304|SUPERIORITY||Mean Difference (Final Values)|20.6||||0.1021|TWO_SIDED|95.0|-4.33|45.54|||t-test, 2 sided|No adjustment for multiple comparisons.|Mean cortical silent period (CSP; units = milliseconds) in the CN group minus mean CSP in the MCI group. Positive values indicate a longer cortical silent period in the control group.|||45.54|-4.33|0.1021
72390833|NCT03652012|144289305|SUPERIORITY||Mean Difference (Final Values)|0.208||||0.19|TWO_SIDED|95.0|-0.113|0.529|||t-test, 2 sided|||||0.529|-0.113|0.19
72390834|NCT03652012|144289306|SUPERIORITY||Mean Difference (Net)|0.0078||||0.97|TWO_SIDED|95.0|-0.51|0.5|||t-test, 2 sided|||||0.50|-0.51|0.97
72390835|NCT01302834|144289320|NON_INFERIORITY|The non-inferiority margin was set at 1.45 (hazard ratio scale; IMRT + Cetuximab / IMRT + Cisplatin). If the upper limit of the 95% confidence interval was \<1.45, non-inferiority would be concluded. Design was based on a group sequential design with 3 interim analyses, one-sided 0.05, and 80% power.|Hazard Ratio (HR)|1.45|||||ONE_SIDED|95.0||1.94|||||Reference level = IMRT + Cisplatin|||1.94||
72619516|NCT01313676|144769943|SUPERIORITY_OR_OTHER||Percent reduction in risk of death|8.9|||||TWO_SIDED|95.0|-8.1|23.3|||||Confidence Interval (95%) and Estimated Value is presented for the percent reduction in risk of death at any time up to or on the CED, calculated as (1-hazard ratio)\*100|||23.3|-8.1|
72448407|NCT06182033|144414320|OTHER|||||||0.82|||||||Multilevel Model|Kenward Rogers and Restricted Maximum Likelihood adjustment made to reduce error likelihood||We examined the trajectory across timepoints using a multilevel model that controlled for age. The p value is in reference to the difference between the treatment and control children at the final observation.||||.82
72448408|NCT06182033|144414321|OTHER|||||||0.67|||||||Multilevel Model|Kenward-Rogers and Restricted Maximum Likelihood adjustments in light of small sample size to reduce error likelihood.||We examined the trajectory across timepoints using a multilevel model that controlled for age. The p value is in reference to the difference between the treatment and control children at the final observation.||||.67
72448409|NCT06182033|144414322|OTHER|||||||0.024|||||||Regression, Linear|Kenward-Rogers and Restricted Maximum Likelihood to account for the small sample size.||We examined the trajectory across timepoints using a multilevel model that controlled for age. The p value is in reference to the difference between the treatment and control children at the final observation.||||.024
72448410|NCT06182033|144414323|OTHER|||||||0.013|||||||Regression, Linear|Kenward Rogers and Restricted Maximum Likelihood adjustment made to reduce error likelihood||We examined the trajectory across timepoints using a multilevel model that controlled for age. The p value is in reference to the difference between the treatment and control children at the final observation.||||.013
72448411|NCT04947527|144414338|SUPERIORITY||Mean Difference (Final Values)|-1.5||||0.279|TWO_SIDED|95.0|-4.2|1.2|||t-test, 2 sided|||||1.2|-4.2|0.279
72448412|NCT04947527|144414339|SUPERIORITY||Difference in percentages/proportions|-14.4||||0.023|TWO_SIDED|95.0|-26.7|-2.1|||Chi-squared|||||-2.1|-26.7|0.023
72448413|NCT04947527|144414340|SUPERIORITY||Risk Difference (RD)|-0.09||||0.133|TWO_SIDED||||||Fisher Exact|||||||0.133
72448414|NCT02723591|144414341|SUPERIORITY||Odds Ratio (OR)|1.115||||0.5777|TWO_SIDED|95.0|0.76|1.636|||Regression, Logistic|||Logistic regression with DSA/IA occurrence by Month 12 as response, with treatment group, planned Campath use, KDPI level (as recorded in IVRS), HLA Class II mismatch, recipient age, recipient gender, recipient race, and pre-transplant calculated panel reactivity antibody (cPRA) as fixed effects, and pooled site as a random effect with standard variance components covariance type.||1.636|0.760|0.5777
72448415|NCT02723591|144414344|SUPERIORITY|||||||0.6618|||||||Fisher Exact|||P-values obtained from a 2x3 Exact Test of treatment by strength levels.||||0.6618
72448416|NCT02723591|144414349|SUPERIORITY||Odds Ratio (OR)|1.038||||0.8518|TWO_SIDED|95.0|0.7|1.539|||Regression, Logistic|||Logistic regression with IA occurrence by Month 12 as response, with treatment group, planned Campath use, KDPI level (as recorded in IVRS), HLA Class II mismatch, recipient age, recipient gender, recipient race, and pre-transplant cPRA as fixed effects, and pooled site as a random effect with standard Variance Components covariance type.||1.539|0.700|0.8518
72498467|NCT04355013|144527469|OTHER|Bland-Altman for repeated measures|Bland-Altman for repeated measures|0.24|STANDARD_DEVIATION|0.58|||TWO_SIDED|95.0|-0.9|1.39||||||Nasopharyngeal-Tcore temperatures||1.39|-0.90|
72498468|NCT03155997|144527476|SUPERIORITY||Hazard Ratio (HR)|0.747||||0.00957|TWO_SIDED|95.0|0.598|0.932|||Log Rank|Stratified by Interactive Web Response Systems (IWRS) Geographical Region, IWRS Prior Treatment, IWRS Menopausal Status|Stratified by IWRS Geographical Region, IWRS Prior Treatment, IWRS Menopausal Status|||0.932|0.598|0.00957
72448417|NCT02723591|144414352|SUPERIORITY|||||||1|||||||Fisher Exact|||P-values obtained from a 2-sided Fisher's Exact Test of treatment arm by response.||||1.0000
72448418|NCT02723591|144414353|SUPERIORITY|||||||0.475|||||||Fisher Exact|||P-values obtained from a 2-sided Fisher's Exact Test of treatment arm by response.||||0.4750
72448419|NCT02723591|144414354|SUPERIORITY|||||||0.0939|||||||Fisher Exact|||P-values obtained from a 2-sided Fisher's Exact Test of treatment arm by response.||||0.0939
72448420|NCT02723591|144414357|SUPERIORITY||Odds Ratio (OR)|1.431||||0.116|TWO_SIDED|95.0|0.915|2.24|||Regression, Logistic|||Logistic regression with occurrence of eGFR \< 50 by Month 12 as response, with treatment group, planned Campath use, KDPI level (as recorded in IVRS), HLA Class II mismatch, recipient age, recipient gender, recipient race, and pre-transplant cPRA as fixed effects, and pooled site as a random effect with standard Variance Components covariance type.||2.240|0.915|0.1160
72448421|NCT02723591|144414358|SUPERIORITY||Odds Ratio (OR)|1.212||||0.4995|TWO_SIDED|95.0|0.693|2.12|||Regression, Logistic|||Logistic regression with occurrence of 5-point eGFR decline by Month 12 as response, with treatment group, planned Campath use, KDPI level (as recorded in IVRS), HLA Class II mismatch, recipient age, recipient gender, recipient race, and pre-transplant cPRA as fixed effects, and pooled site as a random effect with standard Variance Components covariance type.||2.120|0.693|0.4995
72448422|NCT02723591|144414376|SUPERIORITY|||||||0.6327|||||||Fisher Exact|||P-values obtained from the Exact Test of treatment arm by Banff scoring levels.||||0.6327
72448423|NCT02723591|144414377|SUPERIORITY|||||||0.9701|||||||Fisher Exact|||P-values obtained from the Exact Test of treatment arm by Banff scoring levels.||||0.9701
72448424|NCT02723591|144414378|SUPERIORITY|||||||0.3127|||||||Fisher Exact|||P-values obtained from the Exact Test of treatment arm by Banff scoring levels.||||0.3127
72448425|NCT02723591|144414379|SUPERIORITY|||||||0.083|||||||Fisher Exact|||P-values obtained from the Exact Test of treatment arm by Banff scoring levels.||||0.0830
72448426|NCT02723591|144414380|SUPERIORITY|||||||0.6022|||||||Fisher Exact|||P-values obtained from the Exact Test of treatment arm by Banff scoring levels.||||0.6022
72498469|NCT03155997|144527478|SUPERIORITY||Hazard Ratio (HR)|0.717|||||TWO_SIDED|95.0|0.559|0.92|||||Stratified by IWRS Geographical Region, IWRS Prior Treatment, IWRS Menopausal Status|||0.920|0.559|
72498470|NCT00331006|144527496|SUPERIORITY_OR_OTHER||Proportion|0.1875||||0.043|ONE_SIDED|95.0|0.053|||the a priori p-value was 0.05 for statistical significance|Exact Binomial|||The null hypothesis is that the proportion of participants in which the inhibitor level falls to less than 5 BU/mL between weeks 6 to 22 and remains below 5 BU/mL at 5-7 days following re-challenge with factor VIII is no more than 0.05|||.053|0.043
72561572|NCT02058160|144653767|SUPERIORITY_OR_OTHER||Difference in percentage|25.52|||<|0.0001|TWO_SIDED|95.0|18.94|32.1||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel||HbA1c \<7.0%: Insulin Glargine/Lixisenatide FRC vs Insulin Glargine|"HbA1c \<7.0%: Insulin Glargine/Lixisenatide FRC vs Insulin Glargine.~Analysis was performed using Cochran-Mantel-Haenszel method stratified on randomization strata of Week -1 HbA1c (\<8.0%, ≥8.0%) and randomization strata of metformin use at screening. This analysis was out of testing order."||32.10|18.94|<0.0001
72619517|NCT01313676|144769943|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.962||||0.655|TWO_SIDED|95.0|0.813|1.139|||Cox Proportional Hazards Model|||||1.139|0.813|0.655
72448427|NCT02723591|144414381|SUPERIORITY|P-values obtained from the Exact Test of treatment arm by Banff scoring levels.||||||0.9249|||||||Fisher Exact|||||||0.9249
72448428|NCT02723591|144414382|SUPERIORITY|||||||0.9136|||||||Fisher Exact|||P-values obtained from the Exact Test of treatment arm by Banff scoring levels.||||0.9136
72498471|NCT00331006|144527497|SUPERIORITY_OR_OTHER||Proportion|0.25|||||TWO_SIDED|95.0|0.073|0.524|||Exact Binomial|||No hypothesis about the value of this proportion was specified in the study design||0.524|0.073|
72448429|NCT02723591|144414383|SUPERIORITY|||||||0.8789|||||||Fisher Exact|||P-values obtained from the Exact Test of treatment arm by Banff scoring levels.||||0.8789
72448430|NCT02723591|144414384|SUPERIORITY|||||||0.5574|||||||Fisher Exact|||P-values obtained from the Exact Test of treatment arm by Banff scoring levels.||||0.5574
72448431|NCT02723591|144414385|SUPERIORITY|||||||0.815|||||||Fisher Exact|||P-values obtained from the Exact Test of treatment arm by Banff scoring levels.||||0.8150
72448432|NCT02723591|144414386|SUPERIORITY|||||||0.5673|||||||Fisher Exact|||P-values obtained from the Exact Test of treatment arm by Banff scoring levels.||||0.5673
72448433|NCT02618577|144414406|SUPERIORITY||adjusted cause-specific hazard ratio|0.81||||0.15|TWO_SIDED|95.0|0.6|1.08|||Cause-spec. Cox Proport. Hazard model|||||1.08|0.6|0.15
72448434|NCT02618577|144414407|SUPERIORITY||adjusted cause-specific hazard ratio|0.79|||||TWO_SIDED|95.0|0.45|1.39||||||||1.39|0.45|
72498472|NCT03304522|144527513|SUPERIORITY||Least Squares (LS) Mean Difference|-1.085|||<|0.0001|TWO_SIDED|95.0|-1.876|-0.293|||Mixed-effects Model for Repeated Measure|||||-0.293|-1.876|<0.0001
72448435|NCT02618577|144414408|SUPERIORITY||adjusted cause-specific hazard ratio|0.89|||||TWO_SIDED|95.0|0.67|1.18||||||||1.18|0.67|
72448436|NCT02618577|144414409|SUPERIORITY||adjusted cause-specific hazard ratio|1.16||||0.28|TWO_SIDED|95.0|0.88|1.53|||Cause-spec. Cox Proport. Hazard model|||||1.53|0.88|0.28
72448437|NCT02618577|144414410|SUPERIORITY||adjusted cause-specific hazard ratio|2.1||||0.002|TWO_SIDED|95.0|1.3|3.38|||Cause-spec. Cox Proport. Hazard model|||||3.38|1.3|0.002
72448438|NCT02618577|144414411|SUPERIORITY||Mean Difference (Final Values)|-0.01|||||TWO_SIDED|95.0|-0.02|0.01|||||Estimation Parameter: baseline adjusted trial-group specific effect estimates (mean difference)|EQ-5D-5L UK Index||0.01|-0.02|
72448439|NCT02618577|144414411|SUPERIORITY||Mean Difference (Final Values)|-0.04|||||TWO_SIDED|95.0|-1.46|1.38|||||Estimation Parameter: baseline adjusted trial-group specific effect estimates (mean difference)|EQ-5D-5L VAS, FU 24months||1.38|-1.46|
72448440|NCT02618577|144414411|SUPERIORITY||Mean Difference (Final Values)|0.27|||||TWO_SIDED|95.0|-0.56|1.09|||||Estimation Parameter: baseline adjusted trial-group specific effect estimates (mean difference)|Karnofsky score||1.09|-0.56|
72448441|NCT02618577|144414412|SUPERIORITY||Mean Difference (Final Values)|-0.12|||||TWO_SIDED|95.0|-1.12|0.87|||||Estimation Parameter: baseline adjusted trial-group specific effect estimates (mean difference)|PACT-Q convenience||0.87|-1.12|
72448442|NCT02618577|144414412|SUPERIORITY||Mean Difference (Final Values)|-1.04|||||TWO_SIDED|95.0|-2.6|0.52|||||Estimation Parameter: baseline adjusted trial-group specific effect estimates (mean difference)|PACT-Q satisfaction||0.52|-2.60|
72448443|NCT02618577|144414415|SUPERIORITY||adjusted cause-specific hazard ratio|0.51|||||TWO_SIDED|95.0|0.27|0.96||||||||0.96|0.27|
72448444|NCT02618577|144414416|SUPERIORITY||adjusted cause-specific hazard ratio|0.9|||||TWO_SIDED|95.0|0.62|1.31||||||||1.31|0.62|
72448445|NCT02151981|144414417|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.3|||<|0.001|TWO_SIDED|95.0|0.23|0.41|||Log Rank||A hazard ratio \<1 favours Osimertinib 80mg|||0.41|0.23|<0.001
72448446|NCT02151981|144414418|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|5.39|||<|0.001|TWO_SIDED|95.0|3.47|8.48|||Regression, Logistic|adjusted for ethnicity (Asian/non-Asian)|odds ratio \>1.0 favours Osimertinib 80 mg|||8.48|3.47|<0.001
72448447|NCT02151981|144414419|SUPERIORITY_OR_OTHER_LEGACY||Ratio of Expected (DoR)|6.22|||<|0.001|TWO_SIDED|95.0|4.04|9.57|||formulae provided in Ellis S et al 2008|Treatments compared by calculating the ratio of the Expected (DoR) using the Log Normal probability distribution for DOR in responding patients||||9.57|4.04|<0.001
72448448|NCT02151981|144414420|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|4.76|||<|0.001|TWO_SIDED|95.0|2.64|8.84|||Regression, Logistic||odds ratio \>1.0 favours Osimertinib 80 mg|||8.84|2.64|<0.001
72448449|NCT02151981|144414421|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS means|-21.62|||<|0.001|TWO_SIDED|95.0|-27.71|-15.52|||ANCOVA|Covariates for ethnicity (Asian, non-Asian) and the baseline sum of diameters of target lesions|LS Mean: Osimertinib -46.93, Chemo -25.3 A difference in LS means \<0 favours Osimertinib 80mg|||-15.52|-27.71|<0.001
72448450|NCT02151981|144414422|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.87||||0.277|TWO_SIDED|95.0|0.67|1.13|||Log Rank||A hazard ratio \<1 favours Osimertinib 80 mg|||1.13|0.67|0.277
72448451|NCT02151981|144414423|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.21|||<|0.001|TWO_SIDED|95.0|0.16|0.28|||Log Rank||A hazard ratio \<1 favors Osimertinib 80mg|||0.28|0.16|<0.001
72448452|NCT02151981|144414424|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.87|||<|0.001|TWO_SIDED|95.0|0.69|1.11|||Log Rank||A hazard ratio \<1 favours Osimertinib 80 mg|||1.11|0.69|<0.001
72498473|NCT03304522|144527516|SUPERIORITY||LS Mean Difference|-1.111|||<|0.0001|TWO_SIDED|95.0|-1.911|-0.312|||Mixed-effects Model for Repeated Measure|||||-0.312|-1.911|<0.0001
72498474|NCT03304522|144527518|SUPERIORITY||LS Mean Difference|-0.6|||<|0.0001|TWO_SIDED|95.0|-1.5|0.3|||Mixed-effects Model for Repeated Measure|||||0.3|-1.5|<0.0001
72498475|NCT00670709|144527522|SUPERIORITY_OR_OTHER_LEGACY||||||<|1e-07||95.0|||||t-test, 2 sided|||||||<0.0000001
72498476|NCT00670709|144527523|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.005||95.0|||||t-test, 2 sided|||HD subjects vs control subjects||||<0.005
72498477|NCT00885365|144527555|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority is shown if the lower limit of the two-sided 95% confidence interval is above the non-inferiority margin set at -4.5%.|difference of least square means|-0.5||||0.64|TWO_SIDED|95.0|-2.58|1.59|||ANCOVA|||Based on previous studies, the difference between reference and placebo after 4-week treatment is assumed to be about 12% and the non-inferiority margin safely placed at 4.5%. With a between-patient SD of 13.5% and estimated difference between treatments of zero, sample size of 143 per group allows a 80% power to show the non-inferiority of Bramitob® versus TOBI®. Accounting for an expected dropout rate of 11%, a minimum of 160 participants per group is required.||1.59|-2.58|0.640
72619518|NCT01313676|144769943|SUPERIORITY_OR_OTHER||Percent reduction in risk of death|3.8|||||TWO_SIDED|95.0|-13.9|18.7|||||Confidence Interval (95%) and Estimated Value is presented for the percent reduction in risk of death at any time up to or on the CED, calculated as (1-hazard ratio)\*100|||18.7|-13.9|
72561573|NCT02058160|144653767|SUPERIORITY_OR_OTHER||Difference in percentage|19.76|||<|0.0001|TWO_SIDED|95.0|13.9|25.62|||Cochran-Mantel-Haenszel||HbA1c ≤6.5%: Insulin Glargine/Lixisenatide FRC vs Insulin Glargine|"HbA1c ≤6.5%: Insulin Glargine/Lixisenatide FRC vs Insulin Glargine.~Analysis was performed using Cochran-Mantel-Haenszel method stratified on randomization strata of Week -1 HbA1c (\<8.0%, ≥8.0%) and randomization strata of metformin use at screening. This analysis was out of testing order."||25.62|13.90|<0.0001
72561574|NCT02058160|144653768|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.43|STANDARD_ERROR_OF_MEAN|0.251|<|0.0001|TWO_SIDED|95.0|-3.925|-2.939||Threshold for significance at 0.05 level.|ANCOVA||Insulin Glargine/Lixisenatide FRC vs Insulin Glargine|Testing according to the hierarchical testing procedure (continued only if previous endpoints were statistically significant). Analysis was performed using analysis of covariance (ANCOVA) model with treatment groups, randomization strata of Week -1 HbA1c (\<8.0, ≥8.0%), randomization strata of metformin use at screening and country as fixed effects and baseline 2-hour plasma glucose excursion value as a covariate.||-2.939|-3.925|<0.0001
72390836|NCT01302834|144289321|SUPERIORITY||Hazard Ratio (HR)|1.72||||0.0002|TWO_SIDED|95.0|1.29|2.29|||Log Rank|Two-sided significance level = 0.05|Reference level = IMRT + Cisplatin|||2.29|1.29|0.0002
72390837|NCT01302834|144289322|SUPERIORITY||Hazard Ratio (HR)|2.05||||0.0005|TWO_SIDED|95.0|1.35|3.1|||Log Rank|Two-sided significance level = 0.05|Reference level = IMRT + Cisplatin|||3.10|1.35|0.0005
72390838|NCT01302834|144289323|SUPERIORITY||Hazard Ratio (HR)|1.49||||0.09|TWO_SIDED|95.0|0.94|2.36||Two-sided significance level = 0.05|Log Rank||Reference level = IMRT + Cisplatin|||2.36|0.94|0.09
72390839|NCT01302834|144289324|SUPERIORITY||Hazard Ratio (HR)|0.99||||0.95|TWO_SIDED|95.0|0.61|1.58||Two-sided significance level = 0.05|Log Rank||Reference level = IMRT + Cisplatin|||1.58|0.61|0.95
72390840|NCT01302834|144289326|SUPERIORITY|||||||1||||||Two-sided significance level = 0.05|Fisher Exact|||||||1.0
72390841|NCT01302834|144289334|SUPERIORITY|||||||0.79||||||Two-sided significance level = 0.05|Fisher Exact|||||||0.79
72390842|NCT01302834|144289337|SUPERIORITY|||||||0.5438||||||One-sided significance level = 0.05|t-test, 1 sided|||||||0.5438
72390843|NCT01302834|144289341|SUPERIORITY|||||||0.7108||||||One-sided significance level = 0.05|t-test, 1 sided|||||||0.7108
72390844|NCT00769392|144289366|OTHER|||||||0.28|||||||single factor analysis of variance|||A comparison of injection discomfort using mean pain scores for all 4 anesthesia intervention agents used in this study.||||0.28
72390845|NCT00769392|144289367|OTHER|||||||0.17|||||||single factor analysis of variance|||A comparison of discomfort of all 4 anesthesia intervention agents used in this study using mean pain scores.||||0.17
72390846|NCT02296320|144289369|SUPERIORITY||Relative risk reduction|31.9||||0.166|TWO_SIDED|90.0|-7.5|56.8|||Poisson regression with robust variance|||The key efficacy analyses were based on 5000 mg MEDI4893 and placebo. Participants who received 2000 mg MEDI4893 were summarized descriptively.||56.8|-7.5|0.166
72390847|NCT02899793|144289398|SUPERIORITY|||||||0.024|||||||Fisher Exact|||Subgroup difference in ORRs||||0.024
72390848|NCT03310021|144289402|SUPERIORITY||Hodges lehman Location shift|-65.5||||0.0275|TWO_SIDED|95.0|-78.0|-58.0|||2-sided Wilcoxon Rank Sum|||||-58.00|-78.00|0.0275
72390849|NCT03310021|144289402|SUPERIORITY||Hodges lehman Location shift|-61.0||||0.025|TWO_SIDED|95.0|-65.0|-44.0|||2-sided Wilcoxon Rank Sum|||||-44.00|-65.00|0.025
72390850|NCT03310021|144289402|SUPERIORITY||Hodges lehman Location shift|-32.5||||0.0136|TWO_SIDED|95.0|-47.0|-9.0|||2-sided Wilcoxon Rank Sum|||||-9.00|-47.00|0.0136
72390851|NCT03310021|144289402|SUPERIORITY||Hodges lehman Location shift|-36.5||||0.0136|TWO_SIDED|95.0|-62.0|-9.0|||2-sided Wilcoxon Rank Sum|||||-9.00|-62.00|0.0136
72390852|NCT03310021|144289402|SUPERIORITY||Hodges lehman Location shift|-59.0||||0.025|TWO_SIDED|95.0|-70.0|-38.0|||2-sided Wilcoxon Rank Sum|||||-38.00|-70.00|0.025
72390853|NCT03310021|144289402|SUPERIORITY||Hodges lehman Location shift|-66.0||||0.0119|TWO_SIDED|95.0|-68.0|-61.0|||2-sided Wilcoxon Rank Sum|||||-61.00|-68.00|0.0119
72390854|NCT03310021|144289402|SUPERIORITY||Hodges lehman Location shift|-15.5||||0.2667|TWO_SIDED|95.0|-38.0|17.0|||2-sided Wilcoxon Rank Sum|||||17.00|-38.00|0.2667
72390855|NCT03310021|144289402|SUPERIORITY||Hodges lehman Location shift|-68.0||||0.0238|TWO_SIDED|95.0|-74.0|-59.0|||2-sided Wilcoxon Rank Sum|||||-59.00|-74.00|0.0238
72390856|NCT03310021|144289402|SUPERIORITY||Hodges lehman Location shift|-56.5||||0.0007|TWO_SIDED|95.0|-65.0|-39.0|||2-sided Wilcoxon Rank Sum|||||-39.00|-65.00|0.0007
72390857|NCT03310021|144289402|SUPERIORITY||Hodges lehman Location shift|-35.0||||0.0121|TWO_SIDED|95.0|-53.0|-24.0|||2-sided Wilcoxon Rank Sum|||||-24.00|-53.00|0.0121
72390858|NCT03310021|144289403|SUPERIORITY||Hodges lehman Location shift|-80.0||||0.0256|TWO_SIDED|95.0|-83.0|-77.0|||2-sided Wilcoxon Rank Sum|||||-77.00|-83.00|0.0256
72390859|NCT03310021|144289403|SUPERIORITY||Hodges lehman Location shift|-79.5||||0.025|TWO_SIDED|95.0|-97.0|-67.0|||2-sided Wilcoxon Rank Sum|||||-67.00|-97.00|0.025
72390860|NCT03310021|144289403|SUPERIORITY||Hodges lehman Location shift|-37.0||||0.074|TWO_SIDED|95.0|-66.0|5.0|||2-sided Wilcoxon Rank Sum|||||5.00|-66.00|0.074
72390861|NCT03310021|144289403|SUPERIORITY||Hodges lehman Location shift|-10.5||||0.1066|TWO_SIDED|95.0|-59.0|10.0|||2-sided Wilcoxon Rank Sum|||||10.00|-59.00|0.1066
72390862|NCT03310021|144289403|SUPERIORITY||Hodges lehman Location shift|-84.0||||0.0219|TWO_SIDED|95.0|-87.0|-71.0|||2-sided Wilcoxon Rank Sum|||||-71.00|-87.00|0.0219
72390863|NCT03310021|144289403|SUPERIORITY||Hodges lehman Location shift|-78.0||||0.0262|TWO_SIDED|95.0|-83.0|-74.0|||2-sided Wilcoxon Rank Sum|||||-74.0|-83.00|0.0262
72390864|NCT03310021|144289403|SUPERIORITY||Hodges lehman Location shift|-50.0||||0.0412|TWO_SIDED|95.0|-65.0|0.0|||2-sided Wilcoxon Rank Sum|||||0.00|-65.00|0.0412
72390865|NCT03310021|144289403|SUPERIORITY||Hodges lehman Location shift|-89.5||||0.0269|TWO_SIDED|95.0|-93.0|-77.0|||2-sided Wilcoxon Rank Sum|||||-77.00|-93.00|0.0269
72390866|NCT03310021|144289403|SUPERIORITY||Hodges lehman Location shift|-84.0||||0.0026|TWO_SIDED|95.0|-86.0|-69.0|||2-sided Wilcoxon Rank Sum|||||-69.00|-86.00|0.0026
72390867|NCT03310021|144289403|SUPERIORITY||Hodges lehman Location shift|-65.0||||0.0181|TWO_SIDED|95.0|-76.0|-57.0|||2-sided Wilcoxon Rank Sum|||||-57.00|-76.00|0.0181
72390868|NCT03310021|144289404|SUPERIORITY||Hodges lehman Location shift|-81.06||||0.0282|TWO_SIDED|95.0|-92.99|-71.96|||2-sided Wilcoxon Rank Sum|||||-71.96|-92.99|0.0282
72390869|NCT03310021|144289404|SUPERIORITY||Hodges lehman Location shift|-69.15||||0.0282|TWO_SIDED|95.0|-96.91|-48.64|||2-sided Wilcoxon Rank Sum|||||-48.64|-96.91|0.0282
72498478|NCT00885365|144527557|SUPERIORITY_OR_OTHER||difference of least square means|-0.01||||0.634|TWO_SIDED|95.0|-0.08|0.05|||ANCOVA|||Analysis for Week 4||0.05|-0.08|0.634
72498479|NCT00885365|144527558|SUPERIORITY_OR_OTHER||difference of least square means|-0.55||||0.63|TWO_SIDED|95.0|-2.78|1.69|||ANCOVA|||Analysis for Week 4||1.69|-2.78|0.630
72498480|NCT00885365|144527559|SUPERIORITY_OR_OTHER||difference of least square means|-0.02||||0.693|TWO_SIDED|95.0|-0.09|0.06|||ANCOVA|||Analysis for Week 4||0.06|-0.09|0.693
72498481|NCT00885365|144527560|SUPERIORITY_OR_OTHER||difference of least square means|0.51||||0.777|TWO_SIDED|95.0|-3.06|4.09|||ANCOVA|||Analysis for Week 4||4.09|-3.06|0.777
72498482|NCT00885365|144527561|SUPERIORITY_OR_OTHER||difference of least square means|0.04||||0.505|TWO_SIDED|95.0|-0.08|0.15|||ANCOVA|||Analysis for Week 4||0.15|-0.08|0.505
72498483|NCT00885365|144527562|SUPERIORITY_OR_OTHER||difference of least square means|0.04|STANDARD_ERROR_OF_MEAN|0.18||0.82|TWO_SIDED|95.0|-0.31|0.39||A priori threshold for statistical significance is \<= 0.050.|ANCOVA|treatment and country are fixed effects and baseline log10 bacterial load (CFU/g) value is a covariate||Analysis of Week 4 data||0.39|-0.31|0.820
72498484|NCT00885365|144527565|SUPERIORITY_OR_OTHER|||||||0.692||||||A priori threshold for statistical significance is \<= 0.050.|Cochran-Mantel-Haenszel|Test controlling for country.||Week 4||||0.692
72561575|NCT02058160|144653769|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.37|STANDARD_ERROR_OF_MEAN|0.224|<|0.0001|TWO_SIDED|95.0|-1.808|-0.93||Threshold for significance at 0.05 level.|Mixed Models Analysis||Insulin Glargine/Lixisenatide FRC vs Insulin Glargine|Testing according to the hierarchical testing procedure (continued only if previous endpoints were statistically significant). Analysis was performed using MMRM model with treatment groups, randomization strata of Week -1 HbA1c (\<8.0, ≥8.0%), randomization strata of metformin use at screening, scheduled visits, treatment-by-visit interaction and country as fixed effects and baseline body weight value-by-visit interaction as covariates.||-0.93|-1.808|<0.0001
72561576|NCT02058160|144653770|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|0.131|<|0.0001|TWO_SIDED|95.0|-1.154|-0.64||Threshold for significance at 0.05 level.|Mixed Models Analysis||Insulin Glargine/Lixisenatide FRC vs Insulin Glargine|Testing according to the hierarchical testing procedure (continued only if previous endpoints were statistically significant). Analysis was performed using MMRM model with treatment groups, randomization strata of Week -1 HbA1c (\<8.0, ≥8.0%), randomization strata of metformin use at screening, scheduled visits, treatment-by-visit interaction and country as fixed effects and baseline average SMPG value-by-visit interaction as covariates.||-0.64|-1.154|<0.0001
72619519|NCT01313676|144769943|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.964||||0.681|TWO_SIDED|95.0|0.808|1.149|||Cox Proportional Hazards Model|||||1.149|0.808|0.681
72619520|NCT01313676|144769943|SUPERIORITY_OR_OTHER||Percent reduction in risk of death|3.6|||||TWO_SIDED|95.0|-14.9|19.2|||||Confidence Interval (95%) and Estimated Value is presented for the percent reduction in risk of death at any time up to or on the CED, calculated as (1-hazard ratio)\*100|||19.2|-14.9|
72619521|NCT01313676|144769943|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.912||||0.299|TWO_SIDED|95.0|0.767|1.085|||Cox Proportional Hazards Model|||||1.085|0.767|0.299
72619522|NCT01313676|144769943|SUPERIORITY_OR_OTHER||Percent reduction in risk of death|8.8|||||TWO_SIDED|95.0|-8.5|23.3|||||Confidence Interval (95%) and Estimated Value is presented for the percent reduction in risk of death at any time up to or on the CED, calculated as (1-hazard ratio)\*100|||23.3|-8.5|
72498485|NCT00885365|144527565|SUPERIORITY_OR_OTHER|||||||0.128||||||A priori threshold for statistical significance is \<= 0.050.|Cochran-Mantel-Haenszel|Test controlling for country.||Week 8||||0.128
72619523|NCT01313676|144769944|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.0|STANDARD_ERROR_OF_MEAN|3.4||0.019|TWO_SIDED|95.0|1.0|15.0|||Mixed Models Analysis|||||15|1|0.019
72390870|NCT03310021|144289404|SUPERIORITY||Hodges lehman Location shift|-57.39||||0.0085|TWO_SIDED|95.0|-72.07|-40.03|||2-sided Wilcoxon Rank Sum|||||-40.03|-72.07|0.0085
72390871|NCT03310021|144289404|SUPERIORITY||Hodges lehman Location shift|-54.96||||0.0085|TWO_SIDED|95.0|-80.42|-25.5|||2-sided Wilcoxon Rank Sum|||||-25.50|-80.42|0.0085
72498486|NCT00888238|144527576|SUPERIORITY_OR_OTHER||Least Squares Mean|1.7|||<|0.001||90.0|1.47|1.93|||ANOVA|||||1.93|1.47|<0.001
72498487|NCT00888238|144527577|SUPERIORITY_OR_OTHER||Least Squares Mean|1.3|||<|0.001||90.0|1.08|1.52|||ANOVA|||||1.52|1.08|<0.001
72498488|NCT01748799|144527580|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED|||||The level for statistical significance was p\< 0.05.|ANOVA|||Omnibus analysis for Cannabis Withdrawal Scale (CWS) data was a Repeated measures ANOVA (including all the experimental conditions) followed by pair-wise comparisons. The level for statistical significance was p\< 0.05.||||<0.01
72498489|NCT01748799|144527580|SUPERIORITY_OR_OTHER|||||||0.01|TWO_SIDED|||||The level for statistical significance was p\< 0.05.|ANOVA|||Omnibus analysis for Cannabis Withdrawal Checklist (CWC) data was a Repeated measures ANOVA (including all the experimental conditions) followed by pair-wise comparisons. The level for statistical significance was p\< 0.05.||||0.01
72498490|NCT03371355|144527581|SUPERIORITY||Mean Difference in % CFB|-24.0||||0.0343|TWO_SIDED|95.0|-41.0|-2.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in least square mean (LSM) of log (Primary Analysis Time Point/Baseline) was estimated.|||-2|-41|0.0343
72390872|NCT03310021|144289404|SUPERIORITY||Hodges lehman Location shift|-100.25||||0.0282|TWO_SIDED|95.0|-133.08|-84.48|||2-sided Wilcoxon Rank Sum|||||-84.48|-133.08|0.0282
72390873|NCT03310021|144289404|SUPERIORITY||Hodges lehman Location shift|-79.87||||0.0282|TWO_SIDED|95.0|-86.36|-65.74|||2-sided Wilcoxon Rank Sum|||||-65.74|-86.36|0.0282
72390874|NCT03310021|144289404|SUPERIORITY||Hodges lehman Location shift|-65.02||||0.0085|TWO_SIDED|95.0|-89.54|-39.17|||2-sided Wilcoxon Rank Sum|||||-39.17|-89.54|0.0085
72390875|NCT03310021|144289404|SUPERIORITY||Hodges lehman Location shift|-91.29||||0.0282|TWO_SIDED|95.0|-128.88|-60.83|||2-sided Wilcoxon Rank Sum|||||-60.83|-128.88|0.0282
72390876|NCT03310021|144289404|SUPERIORITY||Hodges lehman Location shift|-81.49||||0.0034|TWO_SIDED|95.0|-91.05|-65.96|||2-sided Wilcoxon Rank Sum|||||-65.96|-91.05|0.0034
72498491|NCT03371355|144527581|SUPERIORITY||Mean Difference in % CFB|-44.0|||<|0.0001|TWO_SIDED|95.0|-56.0|-28.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in least square mean (LSM) of log (Primary Analysis Time Point/Baseline) was estimated.|||-28|-56|<0.0001
72498492|NCT03371355|144527581|SUPERIORITY||Mean Difference in % CFB|-37.0||||0.0009|TWO_SIDED|95.0|-52.0|-17.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in least square mean (LSM) of log (Primary Analysis Time Point/Baseline) was estimated.|||-17|-52|0.0009
72448453|NCT04164888|144414492|SUPERIORITY||Least Square Mean|-84.56|STANDARD_ERROR_OF_MEAN|7.137|<|0.0001|TWO_SIDED|95.0|-98.95|-70.18|||ANCOVA|ANCOVA with LOCF||Applying the LOCF method (Last Observation Carried Forward) did not result in any changes at Day 29 or Day 57 due to the lack of missing values and resulted in similar results at Day 85.||-70.18|-98.95|<0.0001
72448454|NCT04164888|144414492|SUPERIORITY||Least Square Mean|-80.43|STANDARD_ERROR_OF_MEAN|7.018|<|0.0001|TWO_SIDED|95.0|-94.58|-66.29|||ANCOVA|ANCOVA with LOCF||Applying the LOCF method (Last Observation Carried Forward) did not result in any changes at Day 29 or Day 57 due to the lack of missing values and resulted in similar results at Day 85.||-66.29|-94.58|<0.0001
72498493|NCT03371355|144527582|SUPERIORITY||Least Squares Mean Difference|-49.87|||<|0.0001|TWO_SIDED|95.0|-62.68|-37.06|||ANCOVA|||||-37.06|-62.68|<0.0001
72498494|NCT03371355|144527582|SUPERIORITY||Least Squares Mean Difference|-71.66|||<|0.0001|TWO_SIDED|95.0|-84.47|-58.85|||ANCOVA|||||-58.85|-84.47|<0.0001
72498495|NCT03371355|144527582|SUPERIORITY||Least Squares Mean Difference|-59.74|||<|0.0001|TWO_SIDED|95.0|-74.04|-45.44|||ANCOVA|||||-45.44|-74.04|<0.0001
72498496|NCT03371355|144527583|SUPERIORITY||Least Squares Mean Difference|-16.5||||0.0327|TWO_SIDED|95.0|-31.59|-1.39|||ANCOVA|||TC||-1.39|-31.59|0.0327
72498497|NCT03371355|144527583|SUPERIORITY||Least Squares Mean Difference|-37.0|||<|0.0001|TWO_SIDED|95.0|-52.15|-21.94|||ANCOVA|||TC||-21.94|-52.15|<0.0001
72498498|NCT03371355|144527583|SUPERIORITY||Least Squares Mean Difference|-31.6||||0.0003|TWO_SIDED|95.0|-48.23|-15.05|||ANCOVA|||TC||-15.05|-48.23|0.0003
72561577|NCT02058160|144653771|SUPERIORITY_OR_OTHER||difference in percentage|20.82|||<|0.0001|TWO_SIDED|95.0|14.98|26.66||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel||Insulin Glargine/Lixisenatide FRC vs Insulin Glargine|Testing according to the hierarchical testing procedure (continued only if previous endpoints were statistically significant). Analysis was performed using Cochran-Mantel-Haenszel method stratified on randomization strata of Week -1 HbA1c (\<8.0%, ≥8.0%) and randomization strata of metformin use at screening.||26.66|14.98|<0.0001
72561578|NCT02058160|144653772|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.26|STANDARD_ERROR_OF_MEAN|0.766||0.7362|TWO_SIDED|95.0|-1.762|1.246||Threshold for significance at 0.05 level.|Mixed Models Analysis||Insulin Glargine/Lixisenatide FRC vs Insulin Glargine|Testing according to the hierarchical testing procedure (continued only if previous endpoints were statistically significant). Analysis was performed using MMRM model with treatment groups, randomization strata of Week -1 HbA1c (\<8.0, ≥8.0%), randomization strata of metformin use at screening, scheduled visits, treatment-by-visit interaction and country as fixed effects and baseline daily insulin glargine dose-by-visit interaction as a covariate.||1.246|-1.762|0.7362
72561579|NCT00926367|144653828|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Dunn's Multiple Comparisons Test|A two-tailed p≤ 0.05 was taken as the level of significance for all comparisons.||||||>0.05
72561580|NCT00926367|144653830|SUPERIORITY_OR_OTHER||||||>|0.05||||||A two-tailed p≤ 0.05 was taken as the level of significance for all comparisons.|Dunn's Multiple Comparisons Test|||||||>0.05
72619524|NCT01313676|144769944|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.0|STANDARD_ERROR_OF_MEAN|3.5||0.026|TWO_SIDED|95.0|1.0|14.0|||Mixed Models Analysis|||||14|1|0.026
72498499|NCT03371355|144527583|SUPERIORITY||Least Squares Mean Difference|7.5||||0.256|TWO_SIDED|95.0|-5.55|20.54|||ANCOVA|||LDL-C||20.54|-5.55|0.2560
72498500|NCT03371355|144527583|SUPERIORITY||Least Squares Mean Difference|-8.6||||0.1795|TWO_SIDED|95.0|-21.26|4.05|||ANCOVA|||LDL-C||4.05|-21.26|0.1795
72498501|NCT03371355|144527583|SUPERIORITY||Least Squares Mean Difference|-8.8||||0.2065|TWO_SIDED|95.0|-22.48|4.95|||ANCOVA|||LDL-C||4.95|-22.48|0.2065
72498502|NCT03371355|144527583|SUPERIORITY||Least Squares Mean Difference|-2.7||||0.1515|TWO_SIDED|95.0|-6.43|1.01|||ANCOVA|||HDL-C||1.01|-6.43|0.1515
72498503|NCT03371355|144527583|SUPERIORITY||Least Squares Mean Difference|-8.6|||<|0.0001|TWO_SIDED|95.0|-12.29|-4.91|||ANCOVA|||HDL-C||-4.91|-12.29|<0.0001
72498504|NCT03371355|144527583|SUPERIORITY||Least Squares Mean Difference|-4.1||||0.0436|TWO_SIDED|95.0|-8.18|-0.12|||ANCOVA|||HDL-C||-0.12|-8.18|0.0436
72619525|NCT01313676|144769944|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.0|STANDARD_ERROR_OF_MEAN|3.4||0.654|TWO_SIDED|95.0|-8.0|5.0|||Mixed Models Analysis|||||5|-8|0.654
72498505|NCT03371355|144527583|SUPERIORITY||Least Squares Mean Difference|-9.1||||0.0224|TWO_SIDED|95.0|-16.94|-1.33|||ANCOVA|||VLDL-C||-1.33|-16.94|0.0224
72498506|NCT03371355|144527583|SUPERIORITY||Least Squares Mean Difference|-15.4||||0.0001|TWO_SIDED|95.0|-22.94|-7.84|||ANCOVA|||VLDL-C||-7.84|-22.94|0.0001
72498507|NCT03371355|144527583|SUPERIORITY||Least Squares Mean Difference|-10.8||||0.0091|TWO_SIDED|95.0|-18.86|-2.78|||ANCOVA|||VLDL-C||-2.78|-18.86|0.0091
72498508|NCT03371355|144527583|SUPERIORITY||Least Squares Mean Difference|-13.9||||0.0748|TWO_SIDED|95.0|-29.12|1.42|||ANCOVA|||Non-HDL-C||1.42|-29.12|0.0748
72498509|NCT03371355|144527583|SUPERIORITY||Least Squares Mean Difference|-28.4||||0.0004|TWO_SIDED|95.0|-43.68|-13.18|||ANCOVA|||Non-HDL-C||-13.18|-43.68|0.0004
72498510|NCT03371355|144527583|SUPERIORITY||Least Squares Mean Difference|-27.4||||0.0016|TWO_SIDED|95.0|-44.08|-10.64|||ANCOVA|||Non-HDL-C||-10.64|-44.08|0.0016
72498511|NCT03371355|144527583|SUPERIORITY||Least Squares Mean Difference|-2.44||||0.6005|TWO_SIDED|95.0|-11.68|6.8|||ANCOVA|||ApoB||6.80|-11.68|0.6005
72498512|NCT03371355|144527583|SUPERIORITY||Least Squares Mean Difference|-9.83||||0.0374|TWO_SIDED|95.0|-19.07|-0.59|||ANCOVA|||ApoB||-0.59|-19.07|0.0374
72498513|NCT03371355|144527583|SUPERIORITY||Least Squares Mean Difference|-5.28||||0.31|TWO_SIDED|95.0|-15.55|5.0|||ANCOVA|||ApoB||5.00|-15.55|0.3100
72498514|NCT03371355|144527583|SUPERIORITY||Least Squares Mean Difference|-1.002||||0.0728|TWO_SIDED|95.0|-2.1|0.09|||ANCOVA|||ApoB-48||0.09|-2.10|0.0728
72498515|NCT03371355|144527583|SUPERIORITY||Least Squares Mean Difference|-1.803||||0.0018|TWO_SIDED|95.0|-2.91|-0.69|||ANCOVA|||ApoB-48||-0.69|-2.91|0.0018
72498516|NCT03371355|144527583|SUPERIORITY||Least Squares Mean Difference|-1.091||||0.0759|TWO_SIDED|95.0|-2.3|0.12|||ANCOVA|||ApoB-48||0.12|-2.30|0.0759
72498517|NCT03371355|144527583|SUPERIORITY||Least Squares Mean Difference|-0.887||||0.8451|TWO_SIDED|95.0|-9.89|8.11|||ANCOVA|||ApoB-100||8.11|-9.89|0.8451
72498518|NCT03371355|144527583|SUPERIORITY||Least Squares Mean Difference|-7.59||||0.0973|TWO_SIDED|95.0|-16.59|1.41|||ANCOVA|||ApoB-100||1.41|-16.59|0.0973
72498519|NCT03371355|144527583|SUPERIORITY||Least Squares Mean Difference|-3.418||||0.5|TWO_SIDED|95.0|-13.45|6.61|||ANCOVA|||ApoB-100||6.61|-13.45|0.5000
72498520|NCT03371355|144527583|SUPERIORITY||Least Squares Mean Difference|-4.753||||0.0008|TWO_SIDED|95.0|-7.47|-2.03|||ANCOVA|||ApoCIII||-2.03|-7.47|0.0008
72448455|NCT04164888|144414492|SUPERIORITY||Least Square Mean|-84.87|STANDARD_ERROR_OF_MEAN|7.009|<|0.0001|TWO_SIDED|95.0|-99.0|-70.75|||ANCOVA|ANCOVA with LOCF||Applying the LOCF method (Last Observation Carried Forward) did not result in any changes at Day 29 or Day 57 due to the lack of missing values and resulted in similar results at Day 85.||-70.75|-99.00|<0.0001
72448456|NCT04164888|144414493|SUPERIORITY||Least Square Mean|-48.03|STANDARD_ERROR_OF_MEAN|7.46|<|0.0001|TWO_SIDED|95.0|-63.06|-32.99|||ANCOVA|ANCOVA with LOCF||Similar changes from baseline were observed for Day 29, Day 57, and Day 85 compared to Day 29, Day 57, and Day 85 LOCF.||-32.99|-63.06|<0.0001
72448457|NCT04164888|144414493|SUPERIORITY||Least Square Mean|-49.59|STANDARD_ERROR_OF_MEAN|7.396|<|0.0001|TWO_SIDED|95.0|-64.5|34.69|||ANCOVA|ANCOVA with LOCF||Similar changes from baseline were observed for Day 29, Day 57, and Day 85 compared to Day 29, Day 57, and Day 85 LOCF.||34.69|-64.50|<0.0001
72448458|NCT04164888|144414493|SUPERIORITY||Least Square Mean|-51.99|STANDARD_ERROR_OF_MEAN|7.616|<|0.0001|TWO_SIDED|95.0|-67.34|-36.64|||ANCOVA|ANCOVA with LOCF||Similar changes from baseline were observed for Day 29, Day 57, and Day 85 compared to Day 29, Day 57, and Day 85 LOCF.||-36.64|-67.34|<0.0001
72448459|NCT04409353|144414495|OTHER|Primary inference will be based on the treatment comparison of least squares means for Day 30, and a p-value will be presented for this time period only. The null hypothesis is that the mean difference in the primary endpoint between the treatment groups and the sham control group is zero, versus the alternative hypothesis that these differences are not zero.|Difference in Least Squares Means|0.47||||0.4884|TWO_SIDED|95.0|-0.87|1.81||A two-sided test performed at the 0.05 level of significance.|Mixed Models Analysis||Distraction-Based VR - Sham VR|The primary analysis will compare the treatment groups, separately, to the control group using a linear mixed model repeated measures (MMRM) analysis. The repeated measures are the change from baseline PROMIS-PI score obtained at Days 7, 15, 21, and 30, respectively. The model will include fixed categorical effects for treatment, week, treatment by week interaction, and the baseline PROMIS-PI t-score as a continuous covariate.||1.81|-0.87|0.4884
72448460|NCT04409353|144414495|OTHER|Primary inference will be based on the treatment comparison of least squares means for Day 30, and a p-value will be presented for this time period only. The null hypothesis is that the mean difference in the primary endpoint between the treatment groups and the sham control group is zero, versus the alternative hypothesis that these differences are not zero.|Difference in Least Squares Means|0.16||||0.8095|TWO_SIDED|95.0|-1.12|1.43||A two-sided test performed at the 0.05 level of significance.|Mixed Models Analysis||Skills-Based VR - Sham VR|The primary analysis will compare the treatment groups, separately, to the control group using a linear mixed model repeated measures (MMRM) analysis. The repeated measures are the change from baseline PROMIS-PI score obtained at Days 7, 15, 21, and 30, respectively. The model will include fixed categorical effects for treatment, week, treatment by week interaction, and the baseline PROMIS-PI t-score as a continuous covariate.||1.43|-1.12|0.8095
72448461|NCT04409353|144414496|OTHER|The inference will be based on the treatment comparison of least squares means for Day 60, and a p-value will be presented for this time period only. The null hypothesis is that the mean difference in the primary endpoint between the treatment groups and the sham control group is zero, versus the alternative hypothesis that these differences are not zero.|Difference in Least Squares Means|0.79||||0.3101|TWO_SIDED|95.0|-0.74|2.32||A two-sided test performed at the 0.05 level of significance.|Mixed Models Analysis||Distraction-Based VR - Sham VR|The analysis will compare the treatment groups, separately, to the control group using a linear mixed model repeated measures (MMRM) analysis. The repeated measures are the change from baseline PROMIS-PI score obtained at Days 60 and 90, respectively. The model will include fixed categorical effects for treatment, week, treatment by week interaction, and the baseline PROMIS-PI t-score as a continuous covariate.||2.32|-0.74|0.3101
72448462|NCT04409353|144414496|OTHER|The inference will be based on the treatment comparison of least squares means for Day 60, and a p-value will be presented for this time period only. The null hypothesis is that the mean difference in the primary endpoint between the treatment groups and the sham control group is zero, versus the alternative hypothesis that these differences are not zero.|Difference in Least Squares Means|-0.42||||0.6328|TWO_SIDED|95.0|-2.13|1.3||A two-sided test performed at the 0.05 level of significance.|Mixed Models Analysis||Skills-Based VR - Sham VR|The analysis will compare the treatment groups, separately, to the control group using a linear mixed model repeated measures (MMRM) analysis. The repeated measures are the change from baseline PROMIS-PI score obtained at Days 60 and 90, respectively. The model will include fixed categorical effects for treatment, week, treatment by week interaction, and the baseline PROMIS-PI t-score as a continuous covariate.||1.30|-2.13|0.6328
72561581|NCT02725411|144653874|OTHER|No formal hypotheses were tested in the study.|LS Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.18|||TWO_SIDED|95.0|-0.38|0.35||||||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.||0.35|-0.38|
72561582|NCT02725411|144653874|OTHER|No formal hypotheses were tested in the study.|LS Mean Difference|-0.24|STANDARD_ERROR_OF_MEAN|0.19|||TWO_SIDED|95.0|-0.6|0.13||||||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.||0.13|-0.60|
72619526|NCT01313676|144769944|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|3.4||0.913|TWO_SIDED|95.0|-6.0|7.0|||Mixed Models Analysis|||||7|-6|0.913
72498521|NCT03371355|144527583|SUPERIORITY||Least Squares Mean Difference|-8.499|||<|0.0001|TWO_SIDED|95.0|-11.18|-5.82|||ANCOVA|||ApoCIII||-5.82|-11.18|<0.0001
72561583|NCT02725411|144653874|OTHER|No formal hypotheses were tested in the study.|LS Mean Difference|-0.27|STANDARD_ERROR_OF_MEAN|0.22|||TWO_SIDED|95.0|-0.7|0.15||||||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.||0.15|-0.70|
72619527|NCT01313676|144769944|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.0|STANDARD_ERROR_OF_MEAN|3.4||0.004|TWO_SIDED|95.0|3.0|16.0|||Mixed Models Analysis|||||16|3|0.004
72619528|NCT01313676|144769945|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.926||||0.475|TWO_SIDED|95.0|0.75|1.143|||Cox Proportional Hazards Model|||||1.143|0.750|0.475
72498522|NCT03371355|144527583|SUPERIORITY||Least Squares Mean Difference|-6.86|||<|0.0001|TWO_SIDED|95.0|-9.78|-3.93|||ANCOVA|||ApoCIII||-3.93|-9.78|<0.0001
72498523|NCT03371355|144527583|SUPERIORITY||Least Squares Mean Difference|-16.8||||0.0003|TWO_SIDED|95.0|-25.8|-7.85|||ANCOVA|||ApoA1||-7.85|-25.80|0.0003
72498524|NCT03371355|144527583|SUPERIORITY||Least Squares Mean Difference|-35.2|||<|0.0001|TWO_SIDED|95.0|-44.07|-26.24|||ANCOVA|||ApoA1||-26.24|-44.07|<0.0001
72498525|NCT03371355|144527583|SUPERIORITY||Least Squares Mean Difference|-21.1|||<|0.0001|TWO_SIDED|95.0|-30.89|-11.39|||ANCOVA|||ApoA1||-11.39|-30.89|<0.0001
72498526|NCT03371355|144527584|SUPERIORITY||Least Squares Mean Difference|0.0128||||0.8299|TWO_SIDED|95.0|-0.1|0.13|||ANCOVA|||||0.13|-0.10|0.8299
72561584|NCT02725411|144653874|OTHER|No formal hypotheses were tested in the study.|LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.22|||TWO_SIDED|95.0|-0.93|-0.07||||||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.||-0.07|-0.93|
72561585|NCT02725411|144653874|OTHER|No formal hypotheses were tested in the study.|LS Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.26|||TWO_SIDED|95.0|-0.69|0.33||||||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.||0.33|-0.69|
72390877|NCT03310021|144289404|SUPERIORITY||Hodges lehman Location shift|-58.47||||0.0189|TWO_SIDED|95.0|-110.86|-46.12|||2-sided Wilcoxon Rank Sum|||||-46.12|-110.86|0.0189
72390878|NCT03310021|144289405|SUPERIORITY||Hodges lehman Location shift|-59.39||||0.0282|TWO_SIDED|95.0|-66.48|-52.62|||2-sided Wilcoxon Rank Sum|||||-52.62|-66.48|0.0282
72390879|NCT03310021|144289405|SUPERIORITY||Hodges lehman Location shift|-59.26||||0.0282|TWO_SIDED|95.0|-70.34|-26.94|||2-sided Wilcoxon Rank Sum|||||-26.94|-70.34|0.0282
72390880|NCT03310021|144289405|SUPERIORITY||Hodges lehman Location shift|-36.76||||0.0085|TWO_SIDED|95.0|-46.14|-29.76|||2-sided Wilcoxon Rank Sum|||||-29.76|-46.14|0.0085
72390881|NCT03310021|144289405|SUPERIORITY||Hodges lehman Location shift|-36.82||||0.0085|TWO_SIDED|95.0|-55.81|-20.46|||2-sided Wilcoxon Rank Sum|||||-20.46|-55.81|0.0085
72390882|NCT03310021|144289405|SUPERIORITY||Hodges lehman Location shift|-61.67||||0.0282|TWO_SIDED|95.0|-75.82|-43.78|||2-sided Wilcoxon Rank Sum|||||-43.78|-75.82|0.0282
72390883|NCT03310021|144289405|SUPERIORITY||Hodges lehman Location shift|-67.63||||0.0282|TWO_SIDED|95.0|-77.4|-61.99|||2-sided Wilcoxon Rank Sum|||||-61.99|-77.40|0.0282
72390884|NCT03310021|144289405|SUPERIORITY||Hodges lehman Location shift|-40.33||||0.0085|TWO_SIDED|95.0|-59.77|-11.17|||2-sided Wilcoxon Rank Sum|||||-11.17|-59.77|0.0085
72390885|NCT03310021|144289405|SUPERIORITY||Hodges lehman Location shift|-59.18||||0.0282|TWO_SIDED|95.0|-101.02|-48.14|||2-sided Wilcoxon Rank Sum|||||-48.14|-101.02|0.0282
72390886|NCT03310021|144289405|SUPERIORITY||Hodges lehman Location shift|-54.63||||0.0027|TWO_SIDED|95.0|-59.14|-41.19|||2-sided Wilcoxon Rank Sum|||||-41.19|-59.14|0.0027
72390887|NCT03310021|144289405|SUPERIORITY||Hodges lehman Location shift|-38.14||||0.0189|TWO_SIDED|95.0|-65.78|-15.37|||2-sided Wilcoxon Rank Sum|||||-15.37|-65.78|0.0189
72390888|NCT03310021|144289406|SUPERIORITY||Hodges lehman Location shift|965.09||||0.0282|TWO_SIDED|95.0|474.48|1377.35|||2-sided Wilcoxon Rank Sum|||||1377.35|474.48|0.0282
72390889|NCT03310021|144289406|SUPERIORITY||Hodges lehman Location shift|1127.29||||0.0282|TWO_SIDED|95.0|769.46|1575.02|||2-sided Wilcoxon Rank Sum|||||1575.02|769.46|0.0282
72390890|NCT03310021|144289406|SUPERIORITY||Hodges lehman Location shift|574.89||||0.0085|TWO_SIDED|95.0|307.65|1175.28|||2-sided Wilcoxon Rank Sum|||||1175.28|307.65|0.0085
72390891|NCT03310021|144289406|SUPERIORITY||Hodges lehman Location shift|715.34||||0.0085|TWO_SIDED|95.0|535.38|836.4|||2-sided Wilcoxon Rank Sum|||||836.40|535.38|0.0085
72390892|NCT03310021|144289406|SUPERIORITY||Hodges lehman Location shift|1141.17||||0.0282|TWO_SIDED|95.0|964.03|1736.78|||2-sided Wilcoxon Rank Sum|||||1736.78|964.03|0.0282
72390893|NCT03310021|144289406|SUPERIORITY||Hodges lehman Location shift|1198.83||||0.0282|TWO_SIDED|95.0|988.82|1670.3|||2-sided Wilcoxon Rank Sum|||||1670.30|988.82|0.0282
72390894|NCT03310021|144289406|SUPERIORITY||Hodges lehman Location shift|721.21||||0.0085|TWO_SIDED|95.0|585.92|1108.92|||2-sided Wilcoxon Rank Sum|||||1108.92|585.92|0.0085
72390895|NCT03310021|144289406|SUPERIORITY||Hodges lehman Location shift|1204.62||||0.0282|TWO_SIDED|95.0|1001.72|1471.45|||2-sided Wilcoxon Rank Sum|||||1471.45|1001.72|0.0282
72390896|NCT03310021|144289406|SUPERIORITY||Hodges lehman Location shift|1180.5||||0.0027|TWO_SIDED|95.0|857.21|1296.02|||2-sided Wilcoxon Rank Sum|||||1296.02|857.21|0.0027
72390897|NCT03310021|144289406|SUPERIORITY||Hodges lehman Location shift|976.59||||0.0189|TWO_SIDED|95.0|585.99|1498.37|||2-sided Wilcoxon Rank Sum|||||1498.37|585.99|0.0189
72390898|NCT03310021|144289407|SUPERIORITY||Hodges lehman Location shift|826.9||||0.0282|TWO_SIDED|95.0|505.4|1362.11|||2-sided Wilcoxon Rank Sum|||||1362.11|505.40|0.0282
72390899|NCT03310021|144289407|SUPERIORITY||Hodges lehman Location shift|1125.7||||0.0282|TWO_SIDED|95.0|873.87|1552.77|||2-sided Wilcoxon Rank Sum|||||1552.77|873.87|0.0282
72390900|NCT03310021|144289407|SUPERIORITY||Hodges lehman Location shift|538.84||||0.0085|TWO_SIDED|95.0|291.2|1077.46|||2-sided Wilcoxon Rank Sum|||||1077.46|291.20|0.0085
72390901|NCT03310021|144289407|SUPERIORITY||Hodges lehman Location shift|687.57||||0.0085|TWO_SIDED|95.0|500.92|902.73|||2-sided Wilcoxon Rank Sum|||||902.73|500.92|0.0085
72390902|NCT03310021|144289407|SUPERIORITY||Hodges lehman Location shift|1012.45||||0.0282|TWO_SIDED|95.0|859.08|1352.05|||2-sided Wilcoxon Rank Sum|||||1352.05|859.08|0.0282
72390903|NCT03310021|144289407|SUPERIORITY||Hodges lehman Location shift|1057.27||||0.0282|TWO_SIDED|95.0|818.96|1634.3|||2-sided Wilcoxon Rank Sum|||||1634.30|818.96|0.0282
72390904|NCT03310021|144289407|SUPERIORITY||Hodges lehman Location shift|630.81||||0.0085|TWO_SIDED|95.0|421.78|1124.28|||2-sided Wilcoxon Rank Sum|||||1124.28|421.78|0.0085
72390905|NCT03310021|144289407|SUPERIORITY||Hodges lehman Location shift|925.84||||0.0282|TWO_SIDED|95.0|663.74|1216.28|||2-sided Wilcoxon Rank Sum|||||1216.28|663.74|0.0282
72390906|NCT03310021|144289407|SUPERIORITY||Hodges lehman Location shift|871.11||||0.0027|TWO_SIDED|95.0|631.67|1051.06|||2-sided Wilcoxon Rank Sum|||||1051.06|631.67|0.0027
72390907|NCT03310021|144289407|SUPERIORITY||Hodges lehman Location shift|874.44||||0.0189|TWO_SIDED|95.0|637.25|1412.21|||2-sided Wilcoxon Rank Sum|||||1412.21|637.25|0.0189
72448463|NCT04409353|144414496|OTHER|The inference will be based on the treatment comparison of least squares means for Day 90, and a p-value will be presented for this time period only. The null hypothesis is that the mean difference in the primary endpoint between the treatment groups and the sham control group is zero, versus the alternative hypothesis that these differences are not zero.|Difference in Least Squares Means|1.16||||0.126|TWO_SIDED|95.0|-0.33|2.64||A two-sided test performed at the 0.05 level of significance.|Mixed Models Analysis||Distraction-Based VR - Sham VR|The analysis will compare the treatment groups, separately, to the control group using a linear mixed model repeated measures (MMRM) analysis. The repeated measures are the change from baseline PROMIS-PI score obtained at Days 60 and 90, respectively. The model will include fixed categorical effects for treatment, week, treatment by week interaction, and the baseline PROMIS-PI t-score as a continuous covariate.||2.64|-0.33|0.1260
72448464|NCT04409353|144414496|OTHER|The inference will be based on the treatment comparison of least squares means for Day 90, and a p-value will be presented for this time period only. The null hypothesis is that the mean difference in the primary endpoint between the treatment groups and the sham control group is zero, versus the alternative hypothesis that these differences are not zero.|Difference in Least Squares Means|-0.51||||0.515|TWO_SIDED|95.0|-2.05|1.03||A two-sided test performed at the 0.05 level of significance.|Mixed Models Analysis||Skills-Based VR - Sham VR|The analysis will compare the treatment groups, separately, to the control group using a linear mixed model repeated measures (MMRM) analysis. The repeated measures are the change from baseline PROMIS-PI score obtained at Days 60 and 90, respectively. The model will include fixed categorical effects for treatment, week, treatment by week interaction, and the baseline PROMIS-PI t-score as a continuous covariate.||1.03|-2.05|0.5150
72448465|NCT04409353|144414497|OTHER|Primary inference will be based on the treatment comparison of least squares means for Day 90, and a p-value will be presented for this time period only. The null hypothesis is that the mean difference in the primary endpoint between the treatment groups and the sham control group is zero, versus the alternative hypothesis that these differences are not zero.|Difference in Least Squares Means|1.43||||0.018|TWO_SIDED|95.0|0.25|2.61||A two-sided test performed at the 0.05 level of significance.|Mixed Models Analysis||Distraction-Based VR - Sham VR|The analysis will compare the treatment groups, separately, to the control group using a linear mixed model repeated measures (MMRM) analysis. The repeated measures are the change from baseline PCS SF-6 score obtained at Days 15, 30, 60, and 90, respectively. The model will include fixed categorical effects for treatment, week, treatment by week interaction, and the baseline PCS SF-6 t-score as a continuous covariate.||2.61|0.25|.0180
72448466|NCT04409353|144414497|OTHER|Primary inference will be based on the treatment comparison of least squares means for Day 90, and a p-value will be presented for this time period only. The null hypothesis is that the mean difference in the primary endpoint between the treatment groups and the sham control group is zero, versus the alternative hypothesis that these differences are not zero.|Difference in Least Squares Means|-0.33||||0.5742|TWO_SIDED|95.0|-1.48|0.82||A two-sided test performed at the 0.05 level of significance.|Mixed Models Analysis||Skills-Based VR - Sham VR|The analysis will compare the treatment groups, separately, to the control group using a linear mixed model repeated measures (MMRM) analysis. The repeated measures are the change from baseline PCS SF-6 score obtained at Days 15, 30, 60, and 90, respectively. The model will include fixed categorical effects for treatment, week, treatment by week interaction, and the baseline PCS SF-6 t-score as a continuous covariate.||0.82|-1.48|0.5742
72448467|NCT04409353|144414498|OTHER|Primary inference will be based on the treatment comparison of least squares means for Day 90, and a p-value will be presented for this time period only. The null hypothesis is that the mean difference in the primary endpoint between the treatment groups and the sham control group is zero, versus the alternative hypothesis that these differences are not zero.|Difference in Least Squares Means|0.39||||0.7338|TWO_SIDED|95.0|-1.85|2.62||A two-sided test performed at the 0.05 level of significance.|Mixed Models Analysis||Distraction-Based VR - Sham VR|The analysis will compare the treatment groups, separately, to the control group using a linear mixed model repeated measures (MMRM) analysis. The repeated measures are the change from baseline PROMIS- Anxiety score obtained at Day 15, 30, 60, and 90, respectively. The model will include fixed categorical effects for treatment, week, treatment by week interaction, and the baseline PROMIS-Anxiety t-score as a continuous covariate.||2.62|-1.85|0.7338
72448468|NCT04409353|144414498|OTHER|Primary inference will be based on the treatment comparison of least squares means for Day 90, and a p-value will be presented for this time period only. The null hypothesis is that the mean difference in the primary endpoint between the treatment groups and the sham control group is zero, versus the alternative hypothesis that these differences are not zero.|Difference in Least Squares Means|0.63||||0.5279|TWO_SIDED|95.0|-1.34|2.6||A two-sided test performed at the 0.05 level of significance.|Mixed Models Analysis||Skills-Based VR - Sham VR|The analysis will compare the treatment groups, separately, to the control group using a linear mixed model repeated measures (MMRM) analysis. The repeated measures are the change from baseline PROMIS-Anxiety score obtained at Days 15, 30, 60, and 90, respectively. The model will include fixed categorical effects for treatment, week, treatment by week interaction, and the baseline PROMIS-Anxiety t-score as a continuous covariate.||2.60|-1.34|0.5279
72469794|NCT01575873|144463472|SUPERIORITY||LS Mean Difference|3.2|||<|0.001|TWO_SIDED|95.0|2.0|4.3||2-sided p-value corresponding to the 2-sided 95% confidence interval|ANCOVA||LS Mean Difference = Denosumab - Risedronate|"Analyses of the primary and secondary endpoints were performed independently within each subpopulation using a fixed-sequence testing procedure to control the experiment-wise type 1 error rate at a two-sided 5% significance level.~The glucocorticoid-continuing subpopulation was analyzed using an ANCOVA model adjusted for treatment, baseline BMD, sex, machine type, baseline BMD-by-machine type interaction, and duration of prior glucocorticoid use (\< 12 months vs ≥ 12 months)."||4.3|2.0|< 0.001
72498527|NCT03371355|144527584|SUPERIORITY||Least Squares Mean Difference|-0.0144||||0.8102|TWO_SIDED|95.0|-0.13|0.1|||ANCOVA|||||0.10|-0.13|0.8102
72498528|NCT03371355|144527584|SUPERIORITY||Least Squares Mean Difference|-0.0146||||0.8223|TWO_SIDED|95.0|-0.14|0.11|||ANCOVA|||||0.11|-0.14|0.8223
72498529|NCT03371355|144527585|SUPERIORITY||Least Squares Mean Difference|7.8||||0.0604|TWO_SIDED|95.0|-0.35|16.02|||ANCOVA|||Lp(a)||16.02|-0.35|0.0604
72619529|NCT01313676|144769945|SUPERIORITY_OR_OTHER||Percent reduction in risk of CV event|7.4|||||TWO_SIDED|95.0|-14.3|25.0|||||Confidence Interval and Estimated Value is presented for the percent reduction in risk of death at any time up to or on the CED, calculated as (1-hazard ratio)\*100|||25.0|-14.3|
72448469|NCT04409353|144414499|OTHER|Primary inference will be based on the treatment comparison of least squares means for Day 90, and a p-value will be presented for this time period only. The null hypothesis is that the mean difference in the primary endpoint between the treatment groups and the sham control group is zero, versus the alternative hypothesis that these differences are not zero.|Difference in Least Squares Means|1.19||||0.1833|TWO_SIDED|95.0|-0.56|2.94||A two-sided test performed at the 0.05 level of significance.|Mixed Models Analysis||Distraction-Based VR - Sham VR|The analysis will compare the treatment groups, separately, to the control group using a linear mixed model repeated measures (MMRM) analysis. The repeated measures are the change from baseline PROMIS-Sleep Disturbance score obtained at Days 15, 30, 60, and 90, respectively. The model will include fixed categorical effects for treatment, week, treatment by week interaction, and the baseline PROMIS-Sleep Disturbance t-score as a continuous covariate.||2.94|-0.56|0.1833
72448470|NCT04409353|144414499|OTHER|Primary inference will be based on the treatment comparison of least squares means for Day 90, and a p-value will be presented for this time period only. The null hypothesis is that the mean difference in the primary endpoint between the treatment groups and the sham control group is zero, versus the alternative hypothesis that these differences are not zero.|Difference in Least Squares Means|-0.33||||0.7006|TWO_SIDED|95.0|-2.04|1.37||A two-sided test performed at the 0.05 level of significance.|Mixed Models Analysis||Skills-Based VR - Sham VR|The analysis will compare the treatment groups, separately, to the control group using a linear mixed model repeated measures (MMRM) analysis. The repeated measures are the change from baseline PROMIS-Sleep Disturbance score obtained at Days 15, 30, 60, and 90, respectively. The model will include fixed categorical effects for treatment, week, treatment by week interaction, and the baseline PROMIS-Sleep Disturbance t-score as a continuous covariate.||1.37|-2.04|0.7006
72448471|NCT04409353|144414500|OTHER||Common Odds Ratio|0.76||||0.1913|TWO_SIDED|95.0|0.5|1.15||A two-sided test performed at the 0.05 level of significance without the continuity correction.|Cochran-Mantel-Haenszel|||The Cochran-Mantel-Haenszel (CMH) test was used to compare the association between time (baseline and day 90) and response (yes or no) while stratifying for the treatment groups. The null hypothesis is that the common odds ratio of the association between time and response across the treatment groups is equal to 1, versus the alternative hypothesis that the common odds ratio is not equal to 1.||1.15|0.50|0.1913
72448472|NCT04409353|144414500|OTHER||Common Odds Ratio|0.83||||0.367|TWO_SIDED|95.0|0.55|1.24||A two-sided test performed at the 0.05 level of significance without the continuity correction.|Cochran-Mantel-Haenszel|||The Cochran-Mantel-Haenszel (CMH) test was used to compare the association between time (baseline and day 90) and response (yes or no) while stratifying for the treatment groups. The null hypothesis is that the common odds ratio of the association between time and response across the treatment groups is equal to 1, versus the alternative hypothesis that the common odds ratio is not equal to 1.||1.24|0.55|0.3670
72448473|NCT04409353|144414501|OTHER|Primary inference will be based on the treatment comparison of least squares means for Day 90, and a p-value will be presented for this time period only. The null hypothesis is that the mean difference in the primary endpoint between the treatment groups and the sham control group is zero, versus the alternative hypothesis that these differences are not zero.|Difference in Least Squares Means|-0.83||||0.1619|TWO_SIDED|95.0|-1.98|0.33||A two-sided test performed at the 0.05 level of significance.|Mixed Models Analysis||Distraction-Based VR - Sham VR|The analysis will compare the treatment groups, separately, to the control group using a linear mixed model repeated measures (MMRM) analysis. The repeated measures are the change from baseline PROMIS- PF score obtained for Day 15, 30, 60, and 90, respectively. The model will include fixed categorical effects for treatment, week, treatment by week interaction, and the baseline PROMIS-PF t-score as a continuous covariate.||0.33|-1.98|0.1619
72469795|NCT01575873|144463473|SUPERIORITY||LS Mean Difference|3.1|||<|0.001|TWO_SIDED|95.0|2.2|3.9||2-sided p-value corresponding to the 2-sided 95% confidence interval|ANCOVA||LS Mean Difference = Denosumab - Risedronate|"Analyses of the primary and secondary endpoints were performed independently within each subpopulation using a fixed-sequence testing procedure to control the experiment-wise type 1 error rate at a two-sided 5% significance level.~The glucocorticoid-initiating subpopulation was analyzed using an ANCOVA model adjusting for treatment, baseline BMD value, sex, machine type, and baseline BMD value-by-machine type interaction."||3.9|2.2|< 0.001
72498530|NCT03371355|144527585|SUPERIORITY||Least Squares Mean Difference|1.6||||0.7048|TWO_SIDED|95.0|-6.61|9.74|||ANCOVA|||Lp(a)||9.74|-6.61|0.7048
72498531|NCT03371355|144527585|SUPERIORITY||Least Squares Mean Difference|-1.7||||0.7024|TWO_SIDED|95.0|-10.65|7.2|||ANCOVA|||Lp(a)||7.20|-10.65|0.7024
72498532|NCT03371355|144527586|SUPERIORITY||Mean Difference in % CFB|-45.0|||<|0.0001|TWO_SIDED|95.0|-54.0|-33.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in least square mean (LSM) of log (Primary Analysis Time Point/Baseline) was estimated.|ANGPTL3||-33|-54|<0.0001
72561586|NCT02725411|144653874|OTHER|No formal hypotheses were tested in the study.|LS Mean Difference|-0.57|STANDARD_ERROR_OF_MEAN|0.26|||TWO_SIDED|95.0|-1.09|-0.06||||||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.||-0.06|-1.09|
72561587|NCT02725411|144653874|OTHER|No formal hypotheses were tested in the study.|LS Mean Difference|-0.34|STANDARD_ERROR_OF_MEAN|0.31|||TWO_SIDED|95.0|-0.94|0.27||||||Week 12: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.||0.27|-0.94|
72619530|NCT01313676|144769945|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.896||||0.317|TWO_SIDED|95.0|0.723|1.111|||Cox Proportional Hazards Model|||||1.111|0.723|0.317
72619531|NCT01313676|144769945|SUPERIORITY_OR_OTHER||Percent reduction in risk of CV event|10.4|||||TWO_SIDED|95.0|-11.1|27.7|||||Confidence Interval and Estimated Value is presented for the percent reduction in risk of death at any time up to or on the CED, calculated as (1-hazard ratio)\*100|||27.7|-11.1|
72561588|NCT02725411|144653874|OTHER|No formal hypotheses were tested in the study.|LS Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.31|||TWO_SIDED|95.0|-1.21|0.0||||||Week 12: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.||0.00|-1.21|
72448474|NCT04409353|144414501|OTHER|Primary inference will be based on the treatment comparison of least squares means for Day 90, and a p-value will be presented for this time period only. The null hypothesis is that the mean difference in the primary endpoint between the treatment groups and the sham control group is zero, versus the alternative hypothesis that these differences are not zero.|Difference in Least Squares Means|-0.04||||0.9569|TWO_SIDED|95.0|-1.31|1.24||A two-sided test performed at the 0.05 level of significance.|Mixed Models Analysis||Skills-Based VR - Sham VR|The analysis will compare the treatment groups, separately, to the control group using a linear mixed model repeated measures (MMRM) analysis. The repeated measures are the change from baseline PROMIS- PF score obtained for Day 15, 30, 60, and 90, respectively. The model will include fixed categorical effects for treatment, week, treatment by week interaction, and the baseline PROMIS-PF t-score as a continuous covariate.||1.24|-1.31|0.9569
72448475|NCT04409353|144414502|OTHER|Primary inference will be based on the treatment comparison of least squares means for Day 90, and a p-value will be presented for this time period only. The null hypothesis is that the mean difference in the primary endpoint between the treatment groups and the sham control group is zero, versus the alternative hypothesis that these differences are not zero.|Difference in Least Squares Means|0.03||||0.9727|TWO_SIDED|95.0|-1.8|1.86||A two-sided test performed at the 0.05 level of significance.|Mixed Models Analysis||Distraction-Based VR - Sham VR|The analysis will compare the treatment groups, separately, to the control group using a linear mixed model repeated measures (MMRM) analysis. The repeated measures are the change from baseline PROMIS-Depression score obtained for Day 15, 30, 60, and 90, respectively. The model will include fixed categorical effects for treatment, week, treatment by week interaction, and the baseline PROMIS-Depression t-score as a continuous covariate.||1.86|-1.80|0.9727
72448476|NCT04409353|144414502|OTHER|Primary inference will be based on the treatment comparison of least squares means for Day 90, and a p-value will be presented for this time period only. The null hypothesis is that the mean difference in the primary endpoint between the treatment groups and the sham control group is zero, versus the alternative hypothesis that these differences are not zero.|Difference in Least Squares Means|0.43||||0.6427|TWO_SIDED|95.0|-1.4|2.26||A two-sided test performed at the 0.05 level of significance.|Mixed Models Analysis||Skills-Based VR - Sham VR|The analysis will compare the treatment groups, separately, to the control group using a linear mixed model repeated measures (MMRM) analysis. The repeated measures are the change from baseline PROMIS-Depression score obtained for Day 15, 30, 60, and 90, respectively. The model will include fixed categorical effects for treatment, week, treatment by week interaction, and the baseline PROMIS-Depression t-score as a continuous covariate.||2.26|-1.40|0.6427
72448477|NCT04409353|144414503|OTHER|The inference will be based on the treatment comparison of least squares means for week 12, and a p-value will be presented for this time period only. The null hypothesis is that the mean difference in the change in the average weekly steps between the treatment groups and the sham control group is zero, versus the alternative hypothesis that these differences are not zero.|Difference in Least Squares Means|691.58||||0.291|TWO_SIDED|95.0|-602.98|1986.14||A two-sided test performed at the 0.05 level of significance.|Mixed Models Analysis||Distraction-Based VR - Sham VR|The analysis will compare the treatment groups, separately, to the control group using a linear mixed model repeated measures (MMRM) analysis. The repeated measures are the change from baseline average weekly steps obtained at weeks 1 thorough 12, respectively. The model will include fixed categorical effects for treatment, week, treatment by week interaction, and the baseline average weekly steps as a continuous covariate.||1986.14|-602.98|0.2910
72448478|NCT04409353|144414503|OTHER|The inference will be based on the treatment comparison of least squares means for week 12, and a p-value will be presented for this time period only. The null hypothesis is that the mean difference in the change in the average weekly steps between the treatment groups and the sham control group is zero, versus the alternative hypothesis that these differences are not zero.|Difference in Least Squares Means|405.68||||0.4842|TWO_SIDED|95.0|-741.79|1553.15||A two-sided test performed at the 0.05 level of significance.|Mixed Models Analysis||Skills-Based VR - Sham VR|The analysis will compare the treatment groups, separately, to the control group using a linear mixed model repeated measures (MMRM) analysis. The repeated measures are the change from baseline average weekly steps obtained at weeks 1 thorough 12, respectively. The model will include fixed categorical effects for treatment, week, treatment by week interaction, and the baseline average weekly steps as a continuous covariate.||1553.15|-741.79|0.4842
72448479|NCT04409353|144414504|OTHER|The inference will be based on the treatment comparison of least squares means for week 12, and a p-value will be presented for this time period only. The null hypothesis is that the mean difference in the change in the average weekly sleep scores between the treatment groups and the sham control group is zero, versus the alternative hypothesis that these differences are not zero.|Difference in Least Squares Means|1.0||||0.4228|TWO_SIDED|95.0|-1.48|3.49||A two-sided test performed at the 0.05 level of significance.|Mixed Models Analysis||Distraction-Based VR - Sham VR|The analysis will compare the treatment groups, separately, to the control group using a linear mixed model repeated measures (MMRM) analysis. The repeated measures are the change from baseline average weekly sleep scores obtained at weeks 1 thorough 12, respectively. The model will include fixed categorical effects for treatment, week, treatment by week interaction, and the baseline sleep score as a continuous covariate.||3.49|-1.48|0.4228
72498533|NCT03371355|144527586|SUPERIORITY||Mean Difference in % CFB|-62.0|||<|0.0001|TWO_SIDED|95.0|-69.0|-54.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in least square mean (LSM) of log (Primary Analysis Time Point/Baseline) was estimated.|ANGPTL3||-54|-69|<0.0001
72498534|NCT03371355|144527586|SUPERIORITY||Mean Difference in % CFB|-58.0|||<|0.0001|TWO_SIDED|95.0|-66.0|-47.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in least square mean (LSM) of log (Primary Analysis Time Point/Baseline) was estimated.|ANGPTL3||-47|-66|<0.0001
72498535|NCT03371355|144527586|SUPERIORITY||Mean Difference in % CFB|-9.0||||0.0309|TWO_SIDED|95.0|-16.0|-1.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in least square mean (LSM) of log (Primary Analysis Time Point/Baseline) was estimated.|TC||-1|-16|0.0309
72498536|NCT03371355|144527586|SUPERIORITY||Mean Difference in % CFB|-19.0|||<|0.0001|TWO_SIDED|95.0|-26.0|-12.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in least square mean (LSM) of log (Primary Analysis Time Point/Baseline) was estimated.|TC||-12|-26|<0.0001
72619532|NCT01313676|144769945|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.988||||0.908|TWO_SIDED|95.0|0.802|1.217|||Cox Proportional Hazards Model|||||1.217|0.802|0.908
72448480|NCT04409353|144414504|OTHER|The inference will be based on the treatment comparison of least squares means for week 12, and a p-value will be presented for this time period only. The null hypothesis is that the mean difference in the change in the average weekly sleep scores between the treatment groups and the sham control group is zero, versus the alternative hypothesis that these differences are not zero.|Difference in Least Squares Means|-0.28||||0.8363|TWO_SIDED|95.0|-2.92|2.37||A two-sided test performed at the 0.05 level of significance.|Mixed Models Analysis||Skills-Based VR - Sham VR|The analysis will compare the treatment groups, separately, to the control group using a linear mixed model repeated measures (MMRM) analysis. The repeated measures are the change from baseline average weekly sleep scores obtained at weeks 1 thorough 12, respectively. The model will include fixed categorical effects for treatment, week, treatment by week interaction, and the baseline sleep score as a continuous covariate.||2.37|-2.92|0.8363
72448481|NCT04409353|144414505|OTHER||Odds Ratio (OR)|0.83||||0.514|TWO_SIDED|95.0|0.48|1.44||A two-sided test performed at the 0.05 level of significance.|Regression, Logistic||Sham VR as the reference group.|"Responder status (Yes vs. No) will be analyzed as the dependent variable using logistic regression, with terms for treatment groups and baseline PROMIS-PI as predictors. The null hypothesis is that there is no difference between the treatment groups, versus the alternative hypothesis that there a difference exists between the treatment groups."||1.44|0.48|0.514
72498537|NCT03371355|144527586|SUPERIORITY||Mean Difference in % CFB|-17.0|||<|0.0001|TWO_SIDED|95.0|-25.0|-9.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in least square mean (LSM) of log (Primary Analysis Time Point/Baseline) was estimated.|TC||-9|-25|<0.0001
72498538|NCT03371355|144527586|SUPERIORITY||Mean Difference in % CFB|6.0||||0.4016|TWO_SIDED|95.0|-7.0|21.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in least square mean (LSM) of log (Primary Analysis Time Point/Baseline) was estimated.|LDL-C||21|-7|0.4016
72498539|NCT03371355|144527586|SUPERIORITY||Mean Difference in % CFB|-7.0||||0.2589|TWO_SIDED|95.0|-18.0|6.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in least square mean (LSM) of log (Primary Analysis Time Point/Baseline) was estimated.|LDL-C||6|-18|0.2589
72498540|NCT03371355|144527586|SUPERIORITY||Mean Difference in % CFB|-12.0||||0.0616|TWO_SIDED|95.0|-24.0|1.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in least square mean (LSM) of log (Primary Analysis Time Point/Baseline) was estimated.|LDL-C||1|-24|0.0616
72498541|NCT03371355|144527586|SUPERIORITY||Mean Difference in % CFB|-8.0||||0.1918|TWO_SIDED|95.0|-18.0|4.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in least square mean (LSM) of log (Primary Analysis Time Point/Baseline) was estimated.|HDL-C||4|-18|0.1918
72498542|NCT03371355|144527586|SUPERIORITY||Mean Difference in % CFB|-24.0|||<|0.0001|TWO_SIDED|95.0|-32.0|-14.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in least square mean (LSM) of log (Primary Analysis Time Point/Baseline) was estimated.|HDL-C||-14|-32|<0.0001
72498543|NCT03371355|144527586|SUPERIORITY||Mean Difference in % CFB|-10.0||||0.1132|TWO_SIDED|95.0|-21.0|3.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in least square mean (LSM) of log (Primary Analysis Time Point/Baseline) was estimated.|HDL-C||3|-21|0.1132
72498544|NCT03371355|144527586|SUPERIORITY||Mean Difference in % CFB|-24.0||||0.0177|TWO_SIDED|95.0|-40.0|-5.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in least square mean (LSM) of log (Primary Analysis Time Point/Baseline) was estimated.|VLDL-C||-5|-40|0.0177
72498545|NCT03371355|144527586|SUPERIORITY||Mean Difference in % CFB|-38.0|||<|0.0001|TWO_SIDED|95.0|-51.0|-23.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in least square mean (LSM) of log (Primary Analysis Time Point/Baseline) was estimated.|VLDL-C||-23|-51|<0.0001
72498546|NCT03371355|144527586|SUPERIORITY||Mean Difference in % CFB|-30.0||||0.0033|TWO_SIDED|95.0|-45.0|-12.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in least square mean (LSM) of log (Primary Analysis Time Point/Baseline) was estimated.|VLDL-C||-12|-45|0.0033
72498547|NCT03371355|144527586|SUPERIORITY||Mean Difference in % CFB|-10.0||||0.0523|TWO_SIDED|95.0|-18.0|0.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in least square mean (LSM) of log (Primary Analysis Time Point/Baseline) was estimated.|Non-HDL-C||0|-18|0.0523
72498548|NCT03371355|144527586|SUPERIORITY||Mean Difference in % CFB|-18.0||||0.0002|TWO_SIDED|95.0|-26.0|-9.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in least square mean (LSM) of log (Primary Analysis Time Point/Baseline) was estimated.|Non-HDL-C||-9|-26|0.0002
72498549|NCT03371355|144527586|SUPERIORITY||Mean Difference in % CFB|-19.0||||0.0004|TWO_SIDED|95.0|-28.0|-9.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in least square mean (LSM) of log (Primary Analysis Time Point/Baseline) was estimated.|Non-HDL-C||-9|-28|0.0004
72498550|NCT03371355|144527586|SUPERIORITY||Mean Difference in % CFB|-3.0||||0.4204|TWO_SIDED|95.0|-12.0|5.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in least square mean (LSM) of log (Primary Analysis Time Point/Baseline) was estimated.|ApoB||5|-12|0.4204
72498551|NCT03371355|144527586|SUPERIORITY||Mean Difference in % CFB|-9.0||||0.0441|TWO_SIDED|95.0|-16.0|0.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in least square mean (LSM) of log (Primary Analysis Time Point/Baseline) was estimated.|ApoB||0|-16|0.0441
72498552|NCT03371355|144527586|SUPERIORITY||Mean Difference in % CFB|-7.0||||0.1324|TWO_SIDED|95.0|-16.0|2.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in least square mean (LSM) of log (Primary Analysis Time Point/Baseline) was estimated.|ApoB||2|-16|0.1324
72498553|NCT03371355|144527586|SUPERIORITY||Mean Difference in % CFB|-29.0||||0.1009|TWO_SIDED|95.0|-53.0|7.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in least square mean (LSM) of log (Primary Analysis Time Point/Baseline) was estimated.|ApoB-48||7|-53|0.1009
72498554|NCT03371355|144527586|SUPERIORITY||Mean Difference in % CFB|-52.0||||0.0005|TWO_SIDED|95.0|-68.0|-28.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in least square mean (LSM) of log (Primary Analysis Time Point/Baseline) was estimated.|ApoB-48||-28|-68|0.0005
72498555|NCT03371355|144527586|SUPERIORITY||Mean Difference in % CFB|-21.0||||0.3004|TWO_SIDED|95.0|-50.0|24.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in least square mean (LSM) of log (Primary Analysis Time Point/Baseline) was estimated.|ApoB-48||24|-50|0.3004
72448482|NCT04409353|144414505|OTHER||Odds Ratio (OR)|1.35||||0.28|TWO_SIDED|95.0|0.78|2.36||A two-sided test performed at the 0.05 level of significance.|Regression, Logistic||Sham VR as the reference group.|"Responder status (Yes vs. No) will be analyzed as the dependent variable using logistic regression, with terms for treatment groups and baseline PROMIS-PI as predictors. The null hypothesis is that there is no difference between the treatment groups, versus the alternative hypothesis that there a difference exists between the treatment groups."||2.36|0.78|0.280
72448483|NCT05309291|144414510|NON_INFERIORITY|The null hypothesis to demonstrate non-inferiority using a 10% margin for λ FLC RR can be expressed as: Ho: μT-μR ≤ -3.783. The alternative hypothesis is expressed as: Ha: μT-μR \> -3.783 where μT denotes the Theranova 400 treatment mean and μR denotes the FX 800 treatment mean.|Mean Difference (Final Values)|16.99|STANDARD_DEVIATION|8.86|<|0.0001|TWO_SIDED|95.0|14.84|19.15|||t-test, 2 sided|T-test was utilized to generate a two-sided 95% confidence interval (CI) for the difference in means.||Non-inferiority of the Theranova 400 Dialyzer compared to the FX 800 Dialyzer in regard to the λ FLC RR at the mid-week treatment day dialysis session was assessed.||19.15|14.84|<0.0001
72448484|NCT05309291|144414511|NON_INFERIORITY|The null hypothesis to demonstrate non-inferiority using a 10% margin for ß2-MG RR can be expressed as Ho: μT-μR ≤ -7.848. The alternative hypothesis is expressed as: Ha: μT-μR \> -7.848, where μT denotes the Theranova 400 treatment mean and μR denotes the FX 800 treatment mean.|Mean Difference (Final Values)|-1.19|STANDARD_DEVIATION|5.55|<|0.0001|TWO_SIDED|95.0|-2.54|0.16|||t-test, 2 sided|T-test was utilized to generate a two-sided 95% confidence interval (CI) for the difference in means.||Non-inferiority of the Theranova 400 Dialyzer compared to the FX 800 Dialyzer in regard to the β2-MG RR at the mid-week treatment day dialysis session was assessed.||0.16|-2.54|<0.0001
72448485|NCT03221426|144414512|SUPERIORITY||Hazard Ratio (HR)|0.81||||0.01501|TWO_SIDED|95.0|0.67|0.98||One-sided p-value based on log-rank test stratified by geographic region (Asia vs. Non-Asia) and tumor staging (II vs. III vs. IVa)|Log Rank||Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by geographic region (Asia vs. Non-Asia) and tumor staging (II vs. III vs. IVa)|||0.98|0.67|0.01501
72448486|NCT03221426|144414513|SUPERIORITY||Difference in Percentage|11.4|||<|1e-05|TWO_SIDED|95.0|8.0|15.3|||Stratified Miettinen and Nurminen|Based on Miettinen \& Nurminen method stratified by geographic region (Asia vs. Non-Asia) and tumor staging (II vs. III vs. IVa)||||15.3|8.0|<0.00001
72448487|NCT03221426|144414514|SUPERIORITY||Hazard Ratio (HR)|0.86||||0.07503|TWO_SIDED|95.0|0.71|1.06||One-sided p-value based on log-rank test stratified by geographic region (Asia vs. Non-Asia) and tumor staging (II vs. III vs. IVa)|Log Rank||Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by geographic region (Asia vs. Non-Asia) and tumor staging (II vs. III vs. IVa)|||1.06|0.71|0.07503
72448488|NCT03221426|144414519|OTHER||Hazard Ratio (HR)|0.82||||0.04125|TWO_SIDED|95.0|0.65|1.03||One-sided p-value based on log-rank test with stratification|Log Rank||Cox regression model with Efron's method of tie handling with treatment as a covariate with stratification|||1.03|0.65|0.04125
72448489|NCT03221426|144414520|SUPERIORITY||Hazard Ratio (HR)|0.86||||0.04493|TWO_SIDED|95.0|0.71|1.03||One-sided p-value based on log-rank test stratified by geographic region (Asia vs. Non-Asia), tumor staging (II vs. III vs. IVa), and chemotherapy backbone (XP/FP vs. FLOT)|Log Rank||Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by geographic region (Asia vs. Non-Asia), tumor staging (II vs. III vs. IVa), and chemotherapy backbone (XP/FP vs. FLOT)|||1.03|0.71|0.04493
72448490|NCT03221426|144414521|SUPERIORITY||Hazard Ratio (HR)|0.8||||0.00589|TWO_SIDED|95.0|0.67|0.95||One-sided p-value based on log-rank test stratified by geographic region (Asia vs. Non-Asia) and tumor staging (II vs. III vs. IVa)|Log Rank||Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by geographic region (Asia vs. Non-Asia) and tumor staging (II vs. III vs. IVa)|||0.95|0.67|0.00589
72448491|NCT03532282|144414584|SUPERIORITY||coefficient beta for change trajectory|-0.15||||0.001|TWO_SIDED|||||The a-priori threshold for statistical significance was 0.05|Mixed Models Analysis|Mixed effects model incorporating all assessment time points.||||||0.001
72448492|NCT03532282|144414585|SUPERIORITY||coefficient beta for change trajectory|-0.01||||0.01|TWO_SIDED|||||The a-priori threshold for statistical significance was 0.05|Mixed Models Analysis|Mixed effects model incorporating all assessment time points.||||||0.01
72448493|NCT03532282|144414586|SUPERIORITY||coefficient beta for change trajectory|-0.24||||0.0006|TWO_SIDED|||||The a-priori threshold for statistical significance was 0.05|Mixed Models Analysis|Mixed effects model incorporating all assessment time points.||||||0.0006
72448494|NCT03532282|144414587|SUPERIORITY||coefficient beta for change trajectory|-0.04||||0.05|TWO_SIDED|||||The a-priori threshold for statistical significance was 0.05|Mixed Models Analysis|Mixed effects model incorporating all assessment time points.||||||0.05
72498556|NCT03371355|144527586|SUPERIORITY||Mean Difference in % CFB|-2.0||||0.6135|TWO_SIDED|95.0|-10.0|7.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in least square mean (LSM) of log (Primary Analysis Time Point/Baseline) was estimated.|ApoB-100||7|-10|0.6135
72448495|NCT05034328|144414597|SUPERIORITY||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
72448496|NCT05034328|144414598|SUPERIORITY||Hazard Ratio (HR)|1.063||||0.7026|TWO_SIDED|95.0|0.778|1.451|||Regression, Cox|||For each item 2 to 7 of the WURSS-K questionnaire, the impact of the treament chosen on the corresponding common cold symptom duration was analyzed by means of Cox model and p-value (Wald) calculated||1.451|0.778|0.7026
72448497|NCT05034328|144414599|SUPERIORITY||Hazard Ratio (HR)|1.078||||0.6322|TWO_SIDED|95.0|0.792|1.469|||Regression, Cox|||For each item 2 to 7 of the WURSS-K questionnaire, the impact of the treatment chosen on the corresponding common cold symptom duration was analyzed by means of Cox model and p-value (Wald) calculated||1.469|0.792|0.6322
72448498|NCT05034328|144414600|SUPERIORITY||Hazard Ratio (HR)|0.992||||0.9598|TWO_SIDED|95.0|0.726|1.356|||Regression, Cox|||For each item 2 to 7 of the WURSS-K questionnaire, the impact of the treatment chosen on the corresponding common cold symptom duration was analyzed by means of Cox model and p-value (Wald) calculated||1.356|0.726|0.9598
72448499|NCT05034328|144414601|SUPERIORITY||Hazard Ratio (HR)|1.333||||0.1016|TWO_SIDED|95.0|0.945|1.88|||Regression, Cox|||For each item 2 to 7 of the WURSS-K questionnaire, the impact of the treatment chosen on the corresponding common cold symptom duration was analyzed by means of Cox model and p-value (Wald) calculated||1.880|0.945|0.1016
72448500|NCT05034328|144414602|SUPERIORITY||Hazard Ratio (HR)|1.153||||0.3954|TWO_SIDED|95.0|0.83|1.601|||Regression, Cox|||For each item 2 to 7 of the WURSS-K questionnaire, the impact of the treatment chosen on the corresponding common cold symptom duration was analyzed by means of Cox model and p-value (Wald) calculated||1.601|0.830|0.3954
72448501|NCT05034328|144414603|SUPERIORITY||Hazard Ratio (HR)|1.218||||1.218|TWO_SIDED|95.0|0.871|1.703|||Regression, Cox|||For each item 2 to 7 of the WURSS-K questionnaire, the impact of the treatment chosen on the corresponding common cold symptom duration was analyzed by means of Cox model and p-value (Wald) calculated||1.703|0.871|1.218
72448502|NCT05034328|144414604|SUPERIORITY||||||>|0.05|||||||Regression, Logistic|||The impact of the treatment chosen on the risk to develop respiratory complication requiring antibiotic prescription during a 20-day follow-up was analyzed by a multivariate logistic model||||>0.05
72448503|NCT05034328|144414605|SUPERIORITY||Odds Ratio (OR)|0.335||||0.001|TWO_SIDED|95.0|0.174|0.644|||Regression, Logistic|||||0.644|0.174|0.0010
72448504|NCT05445427|144414621|SUPERIORITY|Groups were compared using Wilcoxon rank sum test.||||||0.544|||||||Wilcoxon (Mann-Whitney)|||||||0.544
72448505|NCT05445427|144414622|SUPERIORITY|||||||0.292|||||||ANCOVA|ANCOVA was used with the baseline value used as the covariate.||||||0.292
72448506|NCT02969707|144414623|SUPERIORITY|||||||0.035|||||||t-test, 2 sided|2-sample t-test||Examining the Change in sum of positive z-transformed CC.||||0.035
72448507|NCT02969707|144414623|SUPERIORITY|||||||0.7||||||2-sample t-test|t-test, 2 sided|||Examining the change in sum of all z-transformed CC.||||0.7
72448508|NCT02969707|144414623|SUPERIORITY|2-sample t-test||||||0.11|||||||t-test, 2 sided|||Examining the change in sum of negative z-transformed CC.||||0.11
72448509|NCT02969707|144414623|SUPERIORITY||Mean Difference (Net)|61.98||||0.008|TWO_SIDED||||||t-test, 2 sided|One sample(paired) t-test||Examining the change in positive functional connectivity between the L-DLPFC and the dACC within the active group from pre to post TMS.||||0.008
72448510|NCT02969707|144414625|OTHER||Mann-Whitney U statistic|601.0||||0.046|TWO_SIDED||||||Mann-Whitney U-test 2-tailed|||Non-parametric analysis, comparison of change (post-treatment minus pre-treatment)||||0.046
72448511|NCT02969707|144414625|OTHER||Cohen's R|0.25|||||TWO_SIDED||||||||Estimate of effect size|Non-parametric analysis, comparison of change (post-treatment minus pre-treatment)||||
72448512|NCT02969707|144414626|SUPERIORITY|We assessed the superiority of active over sham.|Mann-Whitney U statistic|702.5|||=|0.412|TWO_SIDED||||||Mann-Whitney U-test 2-tailed|||Pre- to post-rTMS change in HIS scores were calculated for both Active and Sham conditions. Two-tailed t-tests were used to evaluate the difference between the two conditions' change scores.||||=.412
72448513|NCT02969707|144414629|SUPERIORITY|||||||0.037|||||||t-test, 2 sided|2-sample t-test||||||0.037
72448514|NCT02969707|144414629|SUPERIORITY|||||||0.063|||||||t-test, 2 sided|||||||0.063
72448515|NCT02969707|144414629|SUPERIORITY|||||||0.31|||||||t-test, 2 sided|||||||0.31
72448516|NCT02969707|144414634|SUPERIORITY|We assessed the superiority of active over sham.|Cohen's d|-0.234||||0.49|TWO_SIDED||||||Mixed-effects model|||We used standard mixed-effects modeling to estimate the change (slope) in pain in our 2\*2 pre- and post-assessment design. Pain ratings were calculated by averaging pain ratings across 5 assessments under four conditions (TMS with hypnosis, TMS without hypnosis, Sham with hypnosis, Sham without hypnosis). Based on these change estimates, we derived the two main effects (TMS, Hypnosis) and their interaction effect on the change in pain from the pre- to post-treatment assessment.||||0.49
72448517|NCT02969707|144414635|SUPERIORITY|We assessed the superiority of active over sham.|||||=|0.454|||||||t-test, 2 sided|||Pre- to post-rTMS change in SOARS scores were calculated for both Active and Sham conditions. Two-tailed t-tests were used to evaluate the difference between the two conditions' change scores.||||=.454
72498557|NCT03371355|144527586|SUPERIORITY||Mean Difference in % CFB|-7.0||||0.1127|TWO_SIDED|95.0|-15.0|2.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in least square mean (LSM) of log (Primary Analysis Time Point/Baseline) was estimated.|ApoB-100||2|-15|0.1127
72498558|NCT03371355|144527586|SUPERIORITY||Mean Difference in % CFB|-5.0||||0.2576|TWO_SIDED|95.0|-14.0|4.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in least square mean (LSM) of log (Primary Analysis Time Point/Baseline) was estimated.|ApoB-100||4|-14|0.2576
72498559|NCT03371355|144527586|SUPERIORITY||Mean Difference in % CFB|-36.0||||0.0017|TWO_SIDED|95.0|-52.0|-16.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in least square mean (LSM) of log (Primary Analysis Time Point/Baseline) was estimated.|ApoCIII||-16|-52|0.0017
72498560|NCT03371355|144527586|SUPERIORITY||Mean Difference in % CFB|-58.0|||<|0.0001|TWO_SIDED|95.0|-68.0|-45.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in least square mean (LSM) of log (Primary Analysis Time Point/Baseline) was estimated.|ApoCIII||-45|-68|<0.0001
72498561|NCT03371355|144527586|SUPERIORITY||Mean Difference in % CFB|-47.0|||<|0.0001|TWO_SIDED|95.0|-61.0|-29.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in least square mean (LSM) of log (Primary Analysis Time Point/Baseline) was estimated.|ApoCIII||-29|-61|<0.0001
72448518|NCT02969707|144414636|OTHER|Linear regression was used to evaluate the scalar relationship between E/I ratio as it relates to water and Thermal Pain Tolerance with E/I as the independent variable and Thermal Pain Tolerance as the dependent variable.||||||0.023|||||||Regression, Linear|(R² = .104, F(2,48) = 2.794, β = .320, p = .023)||In people with FMS, the linear relationship between Thermal Pain Tolerance and E/I ratio as it relates to water was assessed.||||0.023
72498562|NCT03371355|144527586|SUPERIORITY||Mean Difference in % CFB|-11.0||||0.0193|TWO_SIDED|95.0|-20.0|-2.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in least square mean (LSM) of log (Primary Analysis Time Point/Baseline) was estimated.|ApoAI||-2|-20|0.0193
72448519|NCT02969707|144414636|OTHER|Linear regression was used to evaluate the scalar relationship between E/I ratio as it relates to water and Thermal Pain Threshold with E/I as the independent variable and Thermal Pain Threshold as the dependent variable.||||||0.043|||||||Regression, Linear|(R² = .081, F(1,49) = 4.315, β = .284, p = .043)||In people with FMS, the linear relationship between Thermal Pain Threshold and E/I ratio as it relates to water was assessed.||||0.043
72498563|NCT03371355|144527586|SUPERIORITY||Mean Difference in % CFB|-26.0|||<|0.0001|TWO_SIDED|95.0|-33.0|-19.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in least square mean (LSM) of log (Primary Analysis Time Point/Baseline) was estimated.|ApoAI||-19|-33|<0.0001
72448520|NCT02969707|144414636|OTHER|Linear regression was used to evaluate the scalar relationship between E/I ratio as it relates to creatine and Thermal Pain Tolerance with E/I as the independent variable and Thermal Pain Tolerance as the dependent variable.||||||0.022|||||||Regression, Linear|(R² = .103, F(1,49) = 5.632, β = .321, p = .022)||In people with FMS, the linear relationship between Thermal Pain Tolerance and E/I ratio as it relates to creatine was assessed.||||0.022
72448521|NCT02969707|144414636|OTHER|Linear regression was used to evaluate the scalar relationship between E/I ratio as it relates to creatine and Thermal Pain Threshold with E/I as the independent variable and Thermal Pain Threshold as the dependent variable.||||||0.041|||||||Regression, Linear|(R² = .083, F(1,49) = 4.425, β = .288, p = .041)||In people with FMS, the linear relationship between Thermal Pain Threshold and E/I ratio as it relates to creatine was assessed.||||0.041
72448522|NCT02969707|144414642|SUPERIORITY|||||||0.728|||||||ANCOVA|||Standard ANCOVA testing whether the Post-TMS E/I relative to creatine is predicted for each subject by the intervention (Active / Sham) while covarying for the Pre-TMS E/I ratio relative to creatine.||||0.728
72448523|NCT02969707|144414642|SUPERIORITY|||||||0.72|||||||ANCOVA|||Standard ANCOVA testing whether the Post-TMS E/I relative to water is predicted for each subject by the intervention (Active / Sham) while covarying for the Pre-TMS E/I ratio relative to water.||||0.720
72448524|NCT02675777|144414710|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<.001
72448525|NCT02675777|144414711|SUPERIORITY|||||||0.3|||||||Mixed Models Analysis|||||||0.30
72448526|NCT00691002|144414717|SUPERIORITY||Odds Ratio (OR)|1.28||||0.11|TWO_SIDED|95.0|0.94|1.74|||Cochran-Mantel-Haenszel|||Test for superiority of LEO 80190 ointment versus calcipotriol ointment at Week 8 LOCF (Last Observation Carried Forward).||1.74|0.94|0.11
72448527|NCT00691002|144414717|SUPERIORITY||Odds Ratio (OR)|1.79|||<|0.001|TWO_SIDED|95.0|1.31|2.45|||Cochran-Mantel-Haenszel|||Test for superiority of LEO 80190 ointment versus hydrocortisone ointment at Week 8 LOCF (Last Observation Carried Forward).||2.45|1.31|<0.001
72448528|NCT00691002|144414717|SUPERIORITY||Odds Ratio (OR)|2.7|||<|0.001|TWO_SIDED|95.0|1.8|4.04|||Cochran-Mantel-Haenszel|||Test for superiority of LEO 80190 ointment versus ointment vehicle at Week 8 LOCF (Last Observation Carried Forward).||4.04|1.80|<0.001
72498564|NCT03371355|144527586|SUPERIORITY||Mean Difference in % CFB|-14.0||||0.0063|TWO_SIDED|95.0|-23.0|-4.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in least square mean (LSM) of log (Primary Analysis Time Point/Baseline) was estimated.|ApoAI||-4|-23|0.0063
72561589|NCT02725411|144653874|OTHER|No formal hypotheses were tested in the study.|LS Mean Difference|-0.63|STANDARD_ERROR_OF_MEAN|0.31|||TWO_SIDED|95.0|-1.24|-0.03||||||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.||-0.03|-1.24|
72498565|NCT03371355|144527586|SUPERIORITY||Mean Difference in % CFB|-2.0||||0.8873|TWO_SIDED|95.0|-21.0|23.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in least square mean (LSM) of log (Primary Analysis Time Point/Baseline) was estimated.|FFA||23|-21|0.8873
72498566|NCT03371355|144527586|SUPERIORITY||Mean Difference in % CFB|-8.0||||0.4404|TWO_SIDED|95.0|-27.0|15.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in least square mean (LSM) of log (Primary Analysis Time Point/Baseline) was estimated.|FFA||15|-27|0.4404
72498567|NCT03371355|144527586|SUPERIORITY||Mean Difference in % CFB]|-1.0||||0.9665|TWO_SIDED|95.0|-22.0|27.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in least square mean (LSM) of log (Primary Analysis Time Point/Baseline) was estimated.|FFA||27|-22|0.9665
72498568|NCT03371355|144527586|SUPERIORITY||Mean Difference in % CFB]|-7.0||||0.4133|TWO_SIDED|95.0|-21.0|10.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in least square mean (LSM) of log (Primary Analysis Time Point/Baseline) was estimated.|Lp\[a\]||10|-21|0.4133
72448529|NCT01959607|144414739|OTHER||Geometric LS Mean Ratio|103.5|||||TWO_SIDED|95.0|84.94|126.11|||ANOVA|The model included terms for sequence, subject nested within sequence, period, and product as fixed effect factors.|LS mean ratio (THS 2.2 - Group 1:CC - Group 1)|The objective of this study was to determine the point estimate and precision of the nicotine bioavailability (ratio of THS 2.2:CC) for Cmax, therefore, there was no statistical hypothesis to be tested for this objective.||126.11|84.94|
72448530|NCT01959607|144414740|OTHER||Geometric LS Mean Ratio|96.34|||||TWO_SIDED|95.0|85.1|109.07|||ANOVA|The model included terms for sequence, subject nested within sequence, period, and product as fixed effect factors.|LS mean ratio (THS 2.2 - Group 1:CC - Group 1)|The objective of this study was to determine the point estimate and precision of the nicotine bioavailability (ratio of THS 2.2:CC) for AUC(0-last), therefore, there was no statistical hypothesis to be tested for this objective.||109.07|85.10|
72448531|NCT03084536|144414773|SUPERIORITY|||||||0.68|||||||Kruskal-Wallis|||||||0.68
72448532|NCT03084536|144414774|SUPERIORITY|||||||0.67|||||||Kruskal-Wallis|||||||0.67
72448533|NCT03084536|144414775|SUPERIORITY|||||||0.53|||||||Kruskal-Wallis|||||||0.53
72448534|NCT03084536|144414776|SUPERIORITY|||||||0.44|||||||Kruskal-Wallis|||||||0.44
72448535|NCT03084536|144414777|SUPERIORITY|||||||0.88|||||||Kruskal-Wallis|||||||0.88
72448536|NCT04285515|144414811|SUPERIORITY||Least Squares Mean Difference|-5.7|STANDARD_ERROR_OF_MEAN|0.96|<|0.0001|TWO_SIDED|95.0|-7.6|-3.84|||Mixed Effects Model for Repeated Measure|||||-3.84|-7.60|<0.0001
72448537|NCT04285515|144414812|SUPERIORITY||Least Squares Mean Difference|-5.7|STANDARD_ERROR_OF_MEAN|1.33|<|0.0001|TWO_SIDED|95.0|-8.29|-3.05|||Mixed Effects Model for Repeated Measure|||||-3.05|-8.29|<0.0001
72448538|NCT04285515|144414813|SUPERIORITY||Least Squares Mean Difference|-5.9|STANDARD_ERROR_OF_MEAN|1.35|<|0.0001|TWO_SIDED|95.0|-8.61|-3.29|||Mixed Effects Model for Repeated Measure|||||-3.29|-8.61|<0.0001
72448539|NCT04285515|144414814|SUPERIORITY||Least Squares Mean Difference|-5.6|STANDARD_ERROR_OF_MEAN|0.86|<|0.0001|TWO_SIDED|95.0|-7.25|-3.88|||Mixed Effects Model for Repeated Measure|||||-3.88|-7.25|<0.0001
72498569|NCT03371355|144527586|SUPERIORITY||Mean Difference in % CFB]|-6.0||||0.475|TWO_SIDED|95.0|-20.0|11.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in least square mean (LSM) of log (Primary Analysis Time Point/Baseline) was estimated.|Lp\[a\]||11|-20|0.4750
72619533|NCT01313676|144769945|SUPERIORITY_OR_OTHER||Percent reduction in risk of death|1.2|||||TWO_SIDED|95.0|-21.7|19.8|||||Confidence Interval and Estimated Value is presented for the percent reduction in risk of death at any time up to or on the CED, calculated as (1-hazard ratio)\*100|||19.8|-21.7|
72448540|NCT04285515|144414815|SUPERIORITY||Least Squares Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001|TWO_SIDED|95.0|-0.81|-0.39|||Mixed Effects Model of Repeated Measure|||||-0.39|-0.81|<0.0001
72448541|NCT04285515|144414816|SUPERIORITY||Least Squares Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.15|<|0.0001|TWO_SIDED|95.0|-0.91|-0.31|||Mixed Effects Model for Repeated Measure|||||-0.31|-0.91|<0.0001
72448542|NCT04285515|144414817|SUPERIORITY||Least Squares Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.16||0.0003|TWO_SIDED|95.0|-0.89|-0.27|||Mixed Effects Model for Repeated Measure|||||-0.27|-0.89|0.0003
72448543|NCT04285515|144414818|SUPERIORITY||Least Squares Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001|TWO_SIDED|95.0|-0.82|-0.44|||Mixed Effects Model for Repeated Measure|||||-0.44|-0.82|<0.0001
72448544|NCT01456949|144414826|SUPERIORITY||Kaplan-Meier (product-limit) estimator|66.9|||<|0.001|TWO_SIDED|95.0|61.6|71.7|||Exact binomial|Exact binomial p-value is shown, but the confidence intervals reported are calculated from Greenwood's approximation of the standard error.||||71.7|61.6|<0.001
72448545|NCT01456949|144414827|SUPERIORITY||Kaplan-Meier (product-limit) estimator|2.3|||<|0.001|TWO_SIDED|95.0|1.1|4.5|||Exact binomial|Exact binomial p-value is shown, but the confidence intervals reported are calculated from Greenwood's approximation of the standard error.||||4.5|1.1|<0.001
72448546|NCT01456949|144414828|OTHER|Secondary analyses were exploratory. No formal hypotheses or performance criteria were predefined.|||||||||||||||||Freedom from MAFE's was estimated using Kaplan-Meier methods.|||
72448547|NCT01456949|144414829|OTHER|Secondary analyses were exploratory. No formal hypotheses or performance criteria were predefined.|||||||||||||||||Chronic treatment success was estimated at one and two years using Kaplan-Meier methods.|||
72448548|NCT04753697|144414870|SUPERIORITY||Difference in Least Square Mean|-1.91|STANDARD_ERROR_OF_MEAN|0.544||0.0005|TWO_SIDED|95.0|-2.97|-0.84|||ANCOVA|||||-0.84|-2.97|0.0005
72448549|NCT04753697|144414871|SUPERIORITY||Difference in percentage|26.4|||<|0.0001|TWO_SIDED|95.0|20.6|32.2|||Cochran-Mantel-Haenszel|Imputed data is used in CMH test, which is stratified by Steroid Inadequate Responder/Intolerant status.||||32.2|20.6|<0.0001
72448550|NCT04753697|144414872|SUPERIORITY||DIFFERENCE IN RESPONSE RATE AFTER MI(%)|18.4|||<|0.0001|TWO_SIDED|95.0|11.3|25.5|||Cochran-Mantel-Haenszel|Imputed data is used in CMH test, which is stratified by Steroid Inadequate Responder/Intolerant status.||||25.5|11.3|<0.0001
72448551|NCT04753697|144414872|SUPERIORITY||DIFFERENCE IN RESPONSE RATE AFTER MI(%)|17.0|||<|0.0001|TWO_SIDED|95.0|10.1|24.0||Imputed data is used in CMH test, which is stratified by Steroid Inadequate Responder/Intolerant status.|Cochran-Mantel-Haenszel|||||24.0|10.1|<0.0001
72448552|NCT04753697|144414873|SUPERIORITY||DIFFERENCE IN RESPONSE RATE AFTER MI (%)|40.0|||<|0.0001|TWO_SIDED|95.0|33.3|46.7|||Cochran-Mantel-Haenszel|Imputed data is used in CMH test, which is stratified by Steroid Inadequate Responder/Intolerant status||||46.7|33.3|<0.0001
72448553|NCT04753697|144414874|SUPERIORITY||DIFFERENCE IN RESPONSE RATE AFTER MI (%)|25.7|||<|0.0001|TWO_SIDED|95.0|17.8|33.6|||Cochran-Mantel-Haenszel|Imputed data is used for all in CMH test, which is stratified by Steroid Inadequate Responder/Intolerant status.||||33.6|17.8|<0.0001
72448554|NCT04753697|144414874|SUPERIORITY||DIFFERENCE IN RESPONSE RATE AFTER MI (%)|27.7|||<|0.0001|TWO_SIDED|95.0|19.7|35.7|||Cochran-Mantel-Haenszel|Imputed data is used for all in CMH test, which is stratified by Steroid Inadequate Responder/Intolerant status.||||35.7|19.7|<0.0001
72448555|NCT04753697|144414875|SUPERIORITY||DIFFERENCE IN LSM|-2.26|STANDARD_ERROR_OF_MEAN|0.655||0.0006|TWO_SIDED|95.0|-3.55|-0.98|||ANCOVA|||||-0.98|-3.55|0.0006
72448556|NCT04753697|144414875|SUPERIORITY||DIFFERENCE IN LSM|-2.49|STANDARD_ERROR_OF_MEAN|0.657||0.0002||95.0|-3.78|-1.2|||ANCOVA|||||-1.20|-3.78|0.0002
72448557|NCT04753697|144414876|SUPERIORITY||DIFFERENCE IN LSM|-4.0|STANDARD_ERROR_OF_MEAN|0.42|<|0.0001|TWO_SIDED|95.0|-4.8|-3.2|||ANCOVA|||||-3.2|-4.8|<0.0001
72448558|NCT04753697|144414877|SUPERIORITY||DIFFERENCE IN LSM|-3.5|STANDARD_ERROR_OF_MEAN|0.51|<|0.0001|TWO_SIDED|95.0|-4.5|-2.4|||ANCOVA|||||-2.4|-4.5|<0.0001
72448559|NCT04753697|144414877|SUPERIORITY||DIFFERENCE IN LSM|-3.1|STANDARD_ERROR_OF_MEAN|0.51|<|0.0001|TWO_SIDED|95.0|-4.1|-2.1|||ANCOVA|||||-2.1|-4.1|<0.0001
72448560|NCT04753697|144414878|SUPERIORITY||DIFFERENCE IN LSM|-22.51|STANDARD_ERROR_OF_MEAN|1.528|<|0.0001|TWO_SIDED|95.0|-25.5|-19.51|||ANCOVA|||||-19.51|-25.50|<0.0001
72448561|NCT04753697|144414879|SUPERIORITY||DIFFERENCE IN LSM|-18.13|STANDARD_ERROR_OF_MEAN|1.9|<|0.0001|TWO_SIDED|95.0|-21.85|-14.4|||ANCOVA|||||-14.40|-21.85|<0.0001
72448562|NCT04753697|144414879|SUPERIORITY||DIFFERENCE IN LSM|-19.22|STANDARD_ERROR_OF_MEAN|1.88|<|0.0001|TWO_SIDED|95.0|-22.9|-15.53|||ANCOVA|||||-15.53|-22.90|<0.0001
72448563|NCT04753697|144414880|SUPERIORITY||DIFFERENCE IN LSM|-25.4|STANDARD_ERROR_OF_MEAN|1.793|<|0.0001|TWO_SIDED|95.0|-28.92|-21.89|||ANCOVA|||||-21.89|-28.92|<0.0001
72448564|NCT04753697|144414881|SUPERIORITY||DIFFERENCE IN LSM|-20.82|STANDARD_ERROR_OF_MEAN|2.229|<|0.0001|TWO_SIDED|95.0|-25.17|-18.91|||Cochran-Mantel-Haenszel|||||-18.91|-25.17|<0.0001
72448565|NCT04753697|144414881|SUPERIORITY||DIFFERENCE IN LSM|-23.43|STANDARD_ERROR_OF_MEAN|2.222|<|0.0001|TWO_SIDED|95.0|-27.73|-21.56|||ANCOVA|||||-21.56|-27.73|<0.0001
72448566|NCT04753697|144414882|SUPERIORITY||DIFFERENCE IN LSM|-4.1|STANDARD_ERROR_OF_MEAN|1.174||0.0005|TWO_SIDED|95.0|-6.4|-1.8|||ANCOVA|||||-1.80|-6.40|0.0005
72448567|NCT04753697|144414883|SUPERIORITY||DIFFERENCE IN LSM|-4.35|STANDARD_ERROR_OF_MEAN|1.42||0.0022|TWO_SIDED|95.0|-7.14|-1.57|||ANCOVA|||||-1.57|-7.14|0.0022
72448568|NCT04753697|144414883|SUPERIORITY||Difference in LSM|-5.2|STANDARD_ERROR_OF_MEAN|1.425||0.0003|TWO_SIDED|95.0|-8.0|-2.41|||ANCOVA|||||-2.41|-8.00|0.0003
72448569|NCT04753697|144414884|SUPERIORITY||DIFFERENCE IN RESPONSE RATE AFTER MI (%)|16.9||||0.0016|TWO_SIDED|95.0|6.7|27.2|||ANCOVA|||||27.2|6.7|0.0016
72448570|NCT03701763|144414903|SUPERIORITY||Percentage Adjusted Difference|21.7|||<|0.0001|TWO_SIDED|95.0|11.2|32.1|||Cochran-Mantel-Haenszel|||||32.1|11.2|<0.0001
72448571|NCT03701763|144414904|SUPERIORITY||Percentage Adjusted Difference|29.4|||<|0.0001|TWO_SIDED|95.0|17.8|40.9|||Cochran-Mantel-Haenszel|||||40.9|17.8|<0.0001
72448572|NCT03701763|144414905|SUPERIORITY||Percentage Adjusted Difference|38.4|||<|0.0001|TWO_SIDED|95.0|25.6|51.2|||Cochran-Mantel-Haenszel|||||51.2|25.6|<0.0001
72448573|NCT03701763|144414906|SUPERIORITY||Difference in Least Squares Mean|-26.97|STANDARD_ERROR_OF_MEAN|4.572|<|0.0001|TWO_SIDED|95.0|-35.93|-18.0|||ANCOVA|||||-18.00|-35.93|<0.0001
72448574|NCT03701763|144414907|SUPERIORITY||Difference in Least Squares Mean|-34.77|STANDARD_ERROR_OF_MEAN|6.229|<|0.0001|TWO_SIDED|95.0|-46.99|-22.55|||ANCOVA|||||-22.55|-46.99|< 0.0001
72448575|NCT03701763|144414908|SUPERIORITY||Percentage Adjusted Difference|4.1||||0.5616|TWO_SIDED|95.0|-9.8|18.0|||Cochran-Mantel-Haenszel|||||18.0|-9.8|0.5616
72448576|NCT03701763|144414909|SUPERIORITY||Difference in Least Squares Mean|-1.8||||0.0009|TWO_SIDED|95.0|-2.9|-0.8|||ANCOVA|||||-0.8|-2.9|0.0009
72448577|NCT03785964|144414940|SUPERIORITY||Hazard Ratio (HR)|0.29|||<|0.001|TWO_SIDED|95.0|0.15|0.55|||Log Rank|p-value was from a one-sided stratified log-rank test with placebo as reference.||Hazard ratio was estimated from stratified Cox proportional hazards model using the exact method for ties, stratified by tumor location. Placebo was the reference treatment.||0.55|0.15|< 0.001
72448578|NCT03785964|144414941|SUPERIORITY||||||<|0.001||||||Two-sided p-value|Cochran-Mantel-Haenszel|||Cochran-Mantel-Haenszel test for general association stratified by tumor location. Placebo was reference treatment.||||< 0.001
72448579|NCT03785964|144414942|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|An unstructured covariance structure was used and degrees of freedom were estimated using the Kenward-Roger approximation.||Mixed model with repeated measures (MMRM) with treatment and visit as factors, Baseline Brief Pain Inventory Short Form score and primary tumor location (intra-abdominal or extra-abdominal) as covariates, included baseline by visit and treatment by visit interactions. Only participants with a Baseline and at least one post-baseline score were included in the analysis. 40 and 31 participants contributed to this analysis at Cycle 10 from Nirogacestat and Placebo respectively.||||<0.001
72448580|NCT03785964|144414943|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|An unstructured covariance structure was used and degrees of freedom were estimated using the Kenward-Roger approximation.||Mixed model with repeated measures (MMRM) with treatment and visit as factors, Baseline DEsmoid Tumor Symptom Scale score and primary tumor location (intra-abdominal or extra-abdominal) as covariates, included baseline by visit and treatment by visit interactions. Only participants with a Baseline and at least one post-baseline score were included in the analysis. 40 and 32 participants contributed to this analysis at Cycle 10 from Nirogacestat and Placebo respectively.||||<0.001
72448581|NCT03785964|144414944|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|An unstructured covariance structure was used and degrees of freedom were estimated using the Kenward-Roger approximation.||Mixed model with repeated measures (MMRM) with treatment and visit as factors, Baseline score and primary tumor location (intra-abdominal or extra-abdominal) as covariates, included baseline by visit and treatment by visit interactions. Only participants with a Baseline and at least one post-baseline score were included in the analysis. 39 and 28 participants contributed to this analysis at Cycle 10 from Nirogacestat and Placebo respectively.||||<0.001
72448582|NCT03785964|144414945|SUPERIORITY|||||||0.006|||||||Mixed Models Analysis|An unstructured covariance structure was used and degrees of freedom were estimated using the Kenward-Roger approximation.||Mixed model with repeated measures (MMRM) with treatment and visit as factors, Baseline score and primary tumor location (intra-abdominal or extra-abdominal) as covariates, included baseline by visit and treatment by visit interactions. Only participants with a Baseline and at least one post-baseline score were included in the analysis. 38 and 27 participants contributed to this analysis at Cycle 10 from Nirogacestat and Placebo respectively.||||0.006
72448583|NCT03785964|144414946|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|An unstructured covariance structure was used and degrees of freedom were estimated using the Kenward-Roger approximation.||Mixed model with repeated measures (MMRM) with treatment and visit as factors, Baseline score and primary tumor location (intra-abdominal or extra-abdominal) as covariates, included baseline by visit and treatment by visit interactions. Only participants with a Baseline and at least one post-baseline score were included in the analysis. 38 and 28 participants contributed to this analysis at Cycle 10 from Nirogacestat and Placebo respectively.||||<0.001
72498570|NCT03371355|144527586|SUPERIORITY||Mean Difference in % CFB]|-4.0||||0.6354|TWO_SIDED|95.0|-20.0|15.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in least square mean (LSM) of log (Primary Analysis Time Point/Baseline) was estimated.|Lp\[a\]||15|-20|0.6354
72498571|NCT03371355|144527587|SUPERIORITY||Least Squares Mean Difference|-17.2||||0.1799|TWO_SIDED|95.0|-42.53|8.1|||ANCOVA|||||8.10|-42.53|0.1799
72498572|NCT03371355|144527587|SUPERIORITY||Least Squares Mean Difference|13.8||||0.2867|TWO_SIDED|95.0|-11.83|39.49|||ANCOVA|||||39.49|-11.83|0.2867
72498573|NCT03371355|144527587|SUPERIORITY||Least Squares Mean Difference|2.2||||0.8812|TWO_SIDED|95.0|-26.78|31.14|||ANCOVA|||||31.14|-26.78|0.8812
72498574|NCT03371355|144527588|SUPERIORITY||Least Squares Mean Difference|-0.28||||0.3995|TWO_SIDED|95.0|-0.94|0.38|||ANCOVA|||||0.38|-0.94|0.3995
72498575|NCT03371355|144527588|SUPERIORITY||Least Squares Mean Difference|0.08||||0.8155|TWO_SIDED|95.0|-0.59|0.75|||ANCOVA|||||0.75|-0.59|0.8155
72619534|NCT01313676|144769945|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.033||||0.763|TWO_SIDED|95.0|0.834|1.281|||Cox Proportional Hazards Model|||||1.281|0.834|0.763
72498576|NCT03371355|144527588|SUPERIORITY||Least Squares Mean Difference|0.16||||0.6466|TWO_SIDED|95.0|-0.54|0.86|||ANCOVA|||||0.86|-0.54|0.6466
72498577|NCT03371355|144527589|SUPERIORITY||Least Squares Mean Difference|1.39||||0.7393|TWO_SIDED|95.0|-9.66|6.89|||ANCOVA|||||6.89|-9.66|0.7393
72498578|NCT03371355|144527589|SUPERIORITY||Least Squares Mean Difference|-0.13||||0.9744|TWO_SIDED|95.0|-8.45|8.18|||ANCOVA|||||8.18|-8.45|0.9744
72498579|NCT03371355|144527589|SUPERIORITY||Least Squares Mean Difference|3.58||||0.4477|TWO_SIDED|95.0|-5.75|12.91|||ANCOVA|||||12.91|-5.75|0.4477
72498580|NCT03371355|144527590|SUPERIORITY||Least Squares Mean Difference|-1.794||||0.471|TWO_SIDED|95.0|-6.72|3.14|||ANCOVA|||||3.14|-6.72|0.4710
72498581|NCT03371355|144527590|SUPERIORITY||Least Squares Mean Difference|0.26||||0.9169|TWO_SIDED|95.0|-4.68|5.2|||ANCOVA|||||5.20|-4.68|0.9169
72498582|NCT03371355|144527590|SUPERIORITY||Least Squares Mean Difference|2.133||||0.4484|TWO_SIDED|95.0|-3.44|7.7|||ANCOVA|||||7.70|-3.44|0.4484
72498583|NCT03371355|144527591|SUPERIORITY||Least Squares Mean Difference|-23.2||||0.0916|TWO_SIDED|95.0|-50.17|3.83|||ANCOVA|||||3.83|-50.17|0.0916
72498584|NCT03371355|144527591|SUPERIORITY||Least Squares Mean Difference|-11.4||||0.4032|TWO_SIDED|95.0|-38.51|15.63|||ANCOVA|||||15.63|-38.51|0.4032
72448584|NCT03785964|144414947|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|An unstructured covariance structure was used and degrees of freedom were estimated using the Kenward-Roger approximation.||Mixed model with repeated measures (MMRM) with treatment and visit as factors, Baseline score and primary tumor location (intra-abdominal or extra-abdominal) as covariates, included baseline by visit and treatment by visit interactions. Only participants with a Baseline and at least one post-baseline score were included in the analysis. 38 and 28 participants contributed to this analysis at Cycle 10 from Nirogacestat and Placebo respectively.||||<0.001
72448585|NCT04117347|144414953|OTHER|Dose Response Relationship.|Coefficient for an indicator|0.022|STANDARD_ERROR_OF_MEAN|0.054|||TWO_SIDED|95.0|-0.0861723|0.1309519|||||coefficient for an indicator for Light Therapy B (vs. Light Therapy A)|Analysis for left amygdala.||0.1309519|-0.0861723|
72448586|NCT04117347|144414953|OTHER|Dose Response Relationship.|Coefficient for an indicator|0.068|STANDARD_ERROR_OF_MEAN|0.052|||TWO_SIDED|95.0|-0.0363877|0.1730965|||||coefficient for an indicator for Light Therapy C (vs. Light Therapy A)|Analysis for left amygdala.||0.1730965|-0.0363877|
72448587|NCT04117347|144414953|OTHER|Dose Response Relationship.|Coefficient for an indicator|0.043|STANDARD_ERROR_OF_MEAN|0.055|||TWO_SIDED|95.0|-0.0676154|0.1545869|||||coefficient for an indicator for Light Therapy B (vs. Light Therapy A)|Analysis for right amygdala.||0.1545869|-0.0676154|
72448588|NCT04117347|144414953|OTHER|Dose Response Relationship.|Coefficient for an indicator|0.018|STANDARD_ERROR_OF_MEAN|0.053|||TWO_SIDED|95.0|-0.0888691|0.1255146|||||coefficient for an indicator for Light Therapy C (vs. Light Therapy A)|Analysis for right amygdala.||0.1255146|-0.0888691|
72448589|NCT03687086|144414954|SUPERIORITY||Odds Ratio (OR)|1.95|STANDARD_ERROR_OF_MEAN|0.63||0.039|TWO_SIDED|95.0|1.03|3.7|||Regression, Logistic|||||3.70|1.03|.039
72448590|NCT03687086|144414955|SUPERIORITY||Mean Difference (Net)|1.38|STANDARD_ERROR_OF_MEAN|0.97||0.155|TWO_SIDED|95.0|-0.52|3.29|||Mixed Models Analysis|Interaction contrast of Treatment Group (Program A vs. Program B) by Time (9 Weeks vs. baseline)||||3.29|-0.52|0.155
72448591|NCT03687086|144414956|SUPERIORITY||Median Difference (Net)|0.16|STANDARD_ERROR_OF_MEAN|1.04||0.88|TWO_SIDED|95.0|-1.88|2.2|||Mixed Models Analysis|Interaction contrast of Treatment Group (Program A vs. Program B) by Time (6 months vs. baseline)||||2.20|-1.88|0.880
72448592|NCT03687086|144414957|SUPERIORITY||Mean Difference (Net)|-0.48|STANDARD_ERROR_OF_MEAN|0.39||0.228|TWO_SIDED|95.0|-1.25|0.3|||Mixed Models Analysis|Interaction contrast of Treatment Group (Program A vs. Program B) by Time (9 weeks vs. baseline)||||0.30|-1.25|0.228
72448593|NCT03687086|144414958|SUPERIORITY||Mean Difference (Net)|-0.09|STANDARD_ERROR_OF_MEAN|0.44||0.843|TWO_SIDED|95.0|-0.96|0.78|||Mixed Models Analysis|Interaction contrast of Treatment Group (Program A vs. Program B) by Time (6 months vs. baseline)||||0.78|-0.96|0.843
72448594|NCT03687086|144414959|SUPERIORITY||Odds Ratio (OR)|3.68|STANDARD_ERROR_OF_MEAN|1.48||0.001|TWO_SIDED|95.0|1.67|8.12|||Regression, Logistic|||||8.12|1.67|0.001
72448595|NCT03687086|144414960|SUPERIORITY||Mean Difference (Net)|-0.32|STANDARD_ERROR_OF_MEAN|0.42||0.443|TWO_SIDED|95.0|-1.14|0.5|||Mixed Models Analysis|Interaction contrast of Treatment Group (Program A vs. Program B) by Time (9 weeks vs. baseline)||||0.50|-1.14|0.443
72448596|NCT03687086|144414961|SUPERIORITY||Mean Difference (Net)|-0.42|STANDARD_ERROR_OF_MEAN|0.51||0.409|TWO_SIDED|95.0|-1.41|0.58|||Mixed Models Analysis|Interaction contrast of Treatment Group (Program A vs. Program B) by Time (6 months vs. baseline)||||0.58|-1.41|0.409
72448597|NCT02505984|144414970|SUPERIORITY|||||||0.5|||||||Wilcoxon (Mann-Whitney)|||||||0.5
72448598|NCT02505984|144414970|SUPERIORITY|||||||0.093|||||||Wilcoxon (Mann-Whitney)|||||||0.093
72448599|NCT02505984|144414970|SUPERIORITY|||||||0.077|||||||Wilcoxon (Mann-Whitney)|||||||0.077
72448600|NCT02505984|144414970|SUPERIORITY|||||||0.3|||||||Wilcoxon (Mann-Whitney)|||||||0.3
72498585|NCT03371355|144527591|SUPERIORITY||Least Squares Mean Difference|1.9||||0.8959|TWO_SIDED|95.0|-27.56|31.45|||ANCOVA|||||31.45|-27.56|0.8959
72498586|NCT03371355|144527592|SUPERIORITY||Least Squares Mean Difference|-0.052||||0.3202|TWO_SIDED|95.0|-0.16|0.05|||ANCOVA|||||0.05|-0.16|0.3202
72448601|NCT02505984|144414971|SUPERIORITY||||||>|0.9|||||||Wilcoxon (Mann-Whitney)|||||||>0.9
72448602|NCT02505984|144414971|SUPERIORITY|||||||0.4|||||||Wilcoxon (Mann-Whitney)|||||||0.4
72448603|NCT02505984|144414972|SUPERIORITY|||||||0.5|||||||Wilcoxon (Mann-Whitney)|||||||0.5
72448604|NCT02505984|144414972|SUPERIORITY|||||||0.8|||||||Wilcoxon (Mann-Whitney)|||||||0.8
72448605|NCT02505984|144414973|SUPERIORITY|||||||0.7|||||||Wilcoxon (Mann-Whitney)|||||||0.7
72448606|NCT02505984|144414973|SUPERIORITY|||||||0.3|||||||Wilcoxon (Mann-Whitney)|||||||0.3
72448607|NCT02505984|144414973|SUPERIORITY|||||||0.4|||||||Wilcoxon (Mann-Whitney)|||||||0.4
72448608|NCT05194956|144414974|SUPERIORITY||Mean Difference (Net)|8.5||||0.0006|TWO_SIDED|95.0|3.75|13.15|||Two-period two-treatment crossover ANOVA|P-values are calculated taking sequence and period effects into account.|This estimation value assumes period and sequence effects are equal between the treatments.|All units of measure reported for this analysis are the mean within-patient differences between alginate and scan VAS scores (i.e. alginate score - scan score)||13.15|3.75|0.0006
72448609|NCT05194956|144414974|SUPERIORITY|Sequence effects||||||0.1984|||||||ANOVA|||||||0.1984
72448610|NCT05194956|144414974|SUPERIORITY|Period effects||||||0.7494|||||||ANOVA|||||||0.7494
72448611|NCT05194956|144414974|SUPERIORITY|Mixed effects modelling|Mean Difference (Net)|-13.31||||0.001|TWO_SIDED|95.0|-21.29|-5.33|||Mixed Models Analysis|||||-5.33|-21.29|0.001
72448612|NCT05194956|144414975|SUPERIORITY|All units of measure reported for this analysis are the mean within-patient differences between alginate and scan VAS scores (i.e. alginate score - scan score)|Mean Difference (Net)|-3.4||||0.123|TWO_SIDED|95.0|-7.71|0.91||From a 2-period 2-treatment crossover ANOVA, taking sequence and period effects into account|Two-period two-treatment crossover ANOVA||This estimation value assumes period and sequence effects are equal between the treatments.|||0.91|-7.71|0.1230
72448613|NCT05194956|144414975|SUPERIORITY|Sequence effects||||||0.8423|||||||ANOVA|||||||0.8423
72448614|NCT05194956|144414975|SUPERIORITY|Period effects||||||0.9544|||||||ANOVA|||||||0.9544
72498587|NCT03371355|144527592|SUPERIORITY||Least Squares Mean Difference|-0.01||||0.8485|TWO_SIDED|95.0|-0.11|0.09|||ANCOVA|||||0.09|-0.11|0.8485
72498588|NCT03371355|144527592|SUPERIORITY||Least Squares Mean Difference|0.0314||||0.5812|TWO_SIDED|95.0|-0.08|0.14|||ANCOVA|||||0.14|-0.08|0.5812
72498589|NCT03371355|144527593|SUPERIORITY||Least Squares Mean Difference|0.43||||0.6157|TWO_SIDED|95.0|-1.28|2.15|||ANCOVA|||||2.15|-1.28|0.6157
72448615|NCT05194956|144414976|SUPERIORITY|All units of measure reported for this analysis are the mean within-patient differences between alginate and scan VAS scores (i.e. alginate score - scan score)|Mean Difference (Net)|-3.4||||0.0439|TWO_SIDED|95.0|-6.69|-0.12||From a 2-period 2-treatment crossover ANOVA, taking sequence and period effects into account|Two-period two-treatment crossover ANOVA||This estimation value assumes period and sequence effects are equal between the treatments.|||-0.12|-6.69|0.0439
72448616|NCT05194956|144414976|SUPERIORITY|Sequence effects||||||0.3878|||||||ANOVA|||||||0.3878
72448617|NCT05194956|144414976|SUPERIORITY|Period effects||||||0.9772|||||||ANOVA|||||||0.9772
72448618|NCT05194956|144414977|SUPERIORITY|All units of measure reported for this analysis are the mean within-patient differences between alginate and scan VAS scores (i.e. alginate score - scan score)|Mean Difference (Net)|9.6||||0.0213|TWO_SIDED|95.0|1.5|17.79||From a 2-period 2-treatment crossover ANOVA, taking sequence and period effects into account|Two-period two-treatment crossover ANOVA||This estimation value assumes period and sequence effects are equal between the treatments.|||17.79|1.50|0.0213
72448619|NCT05194956|144414977|SUPERIORITY|Sequence effects||||||0.1583|||||||ANOVA|||||||0.1583
72448620|NCT05194956|144414977|SUPERIORITY|Period effects||||||0.4709|||||||ANOVA|||||||0.4709
72498590|NCT03371355|144527593|SUPERIORITY||Least Squares Mean Difference|0.01||||0.9869|TWO_SIDED|95.0|-1.66|1.69|||ANCOVA|||||1.69|-1.66|0.9869
72498591|NCT03371355|144527593|SUPERIORITY||Least Squares Mean Difference|-0.33||||0.7084|TWO_SIDED|95.0|-2.07|1.42|||ANCOVA|||||1.42|-2.07|0.7084
72498592|NCT03371355|144527594|SUPERIORITY||Least Squares Mean Difference|2.79||||0.4431|TWO_SIDED|95.0|-4.41|10.0|||ANCOVA|||SBP||10.00|-4.41|0.4431
72561590|NCT02725411|144653874|OTHER|No formal hypotheses were tested in the study.|LS Mean Difference|-0.23|STANDARD_ERROR_OF_MEAN|0.31|||TWO_SIDED|95.0|-0.84|0.38||||||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.||0.38|-0.84|
72561591|NCT02725411|144653874|OTHER|No formal hypotheses were tested in the study.|LS Mean Difference|-0.76|STANDARD_ERROR_OF_MEAN|0.39|||TWO_SIDED|95.0|-1.53|0.01||||||Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.||0.01|-1.53|
72561592|NCT02725411|144653874|OTHER|No formal hypotheses were tested in the study.|LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.39|||TWO_SIDED|95.0|-1.07|0.47||||||Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.||0.47|-1.07|
72561593|NCT02725411|144653874|OTHER|No formal hypotheses were tested in the study.|LS Mean Difference|-0.87|STANDARD_ERROR_OF_MEAN|0.4|||TWO_SIDED|95.0|-1.65|-0.08||||||Week 32: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.||-0.08|-1.65|
72619535|NCT01313676|144769945|SUPERIORITY_OR_OTHER||Percent reduction in risk of death|-3.3|||||TWO_SIDED|95.0|-28.1|16.6|||||Confidence Interval and Estimated Value is presented for the percent reduction in risk of death at any time up to or on the CED, calculated as (1-hazard ratio)\*100|||16.6|-28.1|
72448621|NCT05194956|144414978|SUPERIORITY|All units of measure reported for this analysis are the mean within-patient differences between alginate and scan VAS scores (i.e. alginate score - scan score)|Mean Difference (Net)|5.3||||0.0146|TWO_SIDED|95.0|1.09|9.46||From a 2-period 2-treatment crossover ANOVA, taking sequence and period effects into account|Two-period two-treatment crossover ANOVA||This estimation value assumes period and sequence effects are equal between the treatments.|||9.46|1.09|0.0146
72448622|NCT05194956|144414978|SUPERIORITY|Sequence effects||||||0.5911|||||||ANOVA|||||||0.5911
72448623|NCT05194956|144414978|SUPERIORITY|Period effects||||||0.5825|||||||ANOVA|||||||0.5825
72448624|NCT05194956|144414979|SUPERIORITY|All units of measure reported for this analysis are the mean within-patient differences between alginate and scan VAS scores (i.e. alginate score - scan score)|Mean Difference (Net)|-5.2||||0.0817|TWO_SIDED|95.0|-11.12|0.69||From a 2-period 2-treatment crossover ANOVA, taking sequence and period effects into account|Two-period two-treatment crossover ANOVA||This estimation value assumes period and sequence effects are equal between the treatments.|||0.69|-11.12|0.0817
72448625|NCT05194956|144414979|SUPERIORITY|Sequence effects||||||0.091|||||||ANOVA|||||||0.0910
72448626|NCT05194956|144414979|SUPERIORITY|Period effects||||||0.2278|||||||ANOVA|||||||0.2278
72448627|NCT05194956|144414980|SUPERIORITY|All units of measure reported for this analysis are the mean within-patient differences between alginate and scan VAS scores (i.e. alginate score - scan score)|Mean Difference (Net)|-2.2||||0.1347|TWO_SIDED|95.0|-5.17|0.69|||Two-period two-treatment crossover ANOVA|From a 2-period 2-treatment crossover ANOVA, taking sequence and period effects into account|This estimation value assumes period and sequence effects are equal between the treatments.|||0.69|-5.17|0.1347
72448628|NCT05194956|144414980|SUPERIORITY|Sequence effects||||||0.9259|||||||ANOVA|||||||0.9259
72448629|NCT05194956|144414980|SUPERIORITY|Period effects||||||0.8225|||||||ANOVA|||||||0.8225
72498593|NCT03371355|144527594|SUPERIORITY||Least Squares Mean Difference|2.08||||0.563|TWO_SIDED|95.0|-5.05|9.22|||ANCOVA|||SBP||9.22|-5.05|0.5630
72498594|NCT03371355|144527594|SUPERIORITY||Least Squares Mean Difference|-1.63||||0.6634|TWO_SIDED|95.0|-9.06|5.79|||ANCOVA|||SBP||5.79|-9.06|0.6634
72498595|NCT03371355|144527594|SUPERIORITY||Least Squares Mean Difference|4.11||||0.0937|TWO_SIDED|95.0|-0.71|8.92|||ANCOVA|||DBP||8.92|-0.71|0.0937
72498596|NCT03371355|144527594|SUPERIORITY||Least Squares Mean Difference|3.49||||0.1522|TWO_SIDED|95.0|-1.31|8.28|||ANCOVA|||DBP||8.28|-1.31|0.1522
72561594|NCT02725411|144653874|OTHER|No formal hypotheses were tested in the study.|LS Mean Difference|-0.25|STANDARD_ERROR_OF_MEAN|0.41|||TWO_SIDED|95.0|-1.06|0.55||||||Week 32: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.||0.55|-1.06|
72619536|NCT01313676|144769945|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.938||||0.545|TWO_SIDED|95.0|0.761|1.155|||Cox Proportional Hazards Model|||||1.155|0.761|0.545
72448630|NCT05194956|144414981|SUPERIORITY|All units of measure reported for this analysis are the mean within-patient differences between alginate and scan VAS scores (i.e. alginate score - scan score)|Median Difference (Net)|-11.2||||0.02|TWO_SIDED|95.0|-20.47|-1.83||From a 2-period 2-treatment crossover ANOVA, taking sequence and period effects into account|Two-period two-treatment crossover ANOVA||This estimation value assumes period and sequence effects are equal between the treatments.|||-1.83|-20.47|0.0200
72448631|NCT05194956|144414981|SUPERIORITY|Sequence effects||||||0.9104|||||||ANOVA|||||||0.9104
72498597|NCT03371355|144527594|SUPERIORITY||Least Squares Mean Difference|1.62||||0.5188|TWO_SIDED|95.0|-3.35|6.59|||ANCOVA|||DBP||6.59|-3.35|0.5188
72448632|NCT05194956|144414981|SUPERIORITY|Period effects||||||0.5194|||||||ANOVA|||||||0.5194
72448633|NCT05194956|144414982|SUPERIORITY|All units of measure reported for this analysis are the mean within-patient differences between alginate and scan VAS scores (i.e. alginate score - scan score)|Mean Difference (Net)|-23.2|||<|5e-05|TWO_SIDED|95.0|-30.71|-15.75||From a 2-period 2-treatment crossover ANOVA, taking sequence and period effects into account|Two-period two-treatment crossover ANOVA||This estimation value assumes period and sequence effects are equal between the treatments.|||-15.75|-30.71|<0.00005
72448634|NCT05194956|144414982|SUPERIORITY|Sequence effects||||||0.1369|||||||ANOVA|||||||0.1369
72448635|NCT05194956|144414982|SUPERIORITY|Period effects||||||0.3366|||||||ANOVA|||||||0.3366
72448636|NCT05194956|144414983|SUPERIORITY|All units of measure reported for this analysis are the mean within-patient differences between alginate and scan VAS scores (i.e. alginate score - scan score)|Mean Difference (Net)|-120.0|||<|5e-05|TWO_SIDED|95.0|-149.54|-90.38|||Two-period two-treatment crossover ANOVA|From a 2-period 2-treatment crossover ANOVA, taking sequence and period effects into account|This estimation value assumes period and sequence effects are equal between the treatments.|||-90.38|-149.54|<0.00005
72448637|NCT05194956|144414983|SUPERIORITY|Sequence effects||||||0.8509|||||||ANOVA|||||||0.8509
72448638|NCT05194956|144414983|SUPERIORITY|Period effects||||||0.0355|||||||ANOVA|||||||0.0355
72448639|NCT04176601|144414988|SUPERIORITY||Mean Difference (Net)|4.32|STANDARD_ERROR_OF_MEAN|1.37|||TWO_SIDED|95.0|1.49|7.15||||||||7.15|1.49|
72448640|NCT04176601|144414989|SUPERIORITY||Mean Difference (Net)|4.7|STANDARD_ERROR_OF_MEAN|1.67|||TWO_SIDED|95.0|1.26|8.15||||||||8.15|1.26|
72448641|NCT04176601|144414990|SUPERIORITY||Mean Difference (Net)|3.68|STANDARD_ERROR_OF_MEAN|1.1|||TWO_SIDED|95.0|1.59|6.14||||||||6.14|1.59|
72448642|NCT04201262|144414991|OTHER||Hazard Ratio (HR)|0.014|||<|0.0001|TWO_SIDED|95.0|0.0|0.103|||Log Rank||HR based on a Cox proportional hazards model, with Firth's adjustment. Confidence interval (CI)= Wald CI or Profile Likelihood CI Limits. HR for ravulizumab compared with placebo presented a 98.6% reduction in risk of relapse, 95% CI (89.7%, 100.0%).|||0.103|0.000|< 0.0001
72619537|NCT01313676|144769945|SUPERIORITY_OR_OTHER||Percent reduction in risk of death|6.2|||||TWO_SIDED|95.0|-15.5|23.9|||||Confidence Interval and Estimated Value is presented for the percent reduction in risk of death at any time up to or on the CED, calculated as (1-hazard ratio)\*100|||23.9|-15.5|
72448643|NCT04201262|144414993|OTHER|||||||0.0122||||||Proportional Odds p-value|Univariate models|||The test of proportional odds was determined from a score test. The proportional odds was evaluated in univariate models.||||0.0122
72448644|NCT05446168|144415001|OTHER|A comparison is not being made between two different treatment groups. Exploratory analysis|Mean Difference (Net)|-0.08|STANDARD_DEVIATION|0.05||0.005|TWO_SIDED|95.0|-0.12|-0.03||A priori threshold for statistical significance is p \< 0.05.|t-test, 2 sided|t = -4.05, df = 7||||-0.03|-0.12|0.005
72448645|NCT05446168|144415002|OTHER|A comparison is not being made between two different treatment groups. Exploratory analysis.|Mean Difference (Net)|4.33|STANDARD_DEVIATION|12.81||0.27|TWO_SIDED|95.0|-3.81|12.47||A priori threshold for statistical significance is p \< 0.05.|t-test, 2 sided|t = 1.17, df = 11||||12.47|-3.81|0.27
72448646|NCT03511664|144415010|SUPERIORITY||Hazard Ratio (HR)|0.4|||<|0.001|TWO_SIDED|99.2|0.29|0.57|||Log Rank|one-sided stratified log-rank test||||0.57|0.29|< 0.001
72448647|NCT03511664|144415011|SUPERIORITY||Hazard Ratio (HR)|0.62|||<|0.001|TWO_SIDED|95.0|0.52|0.74|||Log Rank|one-sided stratified log-rank test||Primary OS Analysis||0.74|0.52|<0.001
72448648|NCT03511664|144415011|SUPERIORITY||Cox Proportional Hazard|0.68|||||TWO_SIDED|95.0|0.58|0.81|||||Cox PH model stratified by LDH (≤260 vs. \>260 IU/L), liver metastases (yes/no), ECOG score (0-1 vs. 2), and NAAD inclusion in best supportive care at randomization (yes/no). IRT data used for stratification|Final OS analysis||0.81|0.58|
72448649|NCT03511664|144415013|SUPERIORITY||Odds Ratio (OR)|24.99|||<|0.001|TWO_SIDED|95.0|6.05|103.24|||Chi-squared|Two-sided Wald's Chi-square test (stratified)||||103.24|6.05|< 0.001
72448650|NCT03511664|144415014|SUPERIORITY||Odds Ratio (OR)|5.79|||<|0.001|TWO_SIDED|95.0|3.18|10.55|||Chi-squared|Two-sided Wald's Chi-square test (stratified)||||10.55|3.18|< 0.001
72448651|NCT03511664|144415016|SUPERIORITY||Hazard Ratio (HR)|0.5|||<|0.001|TWO_SIDED|95.0|0.4|0.62|||Log Rank|Two-sided stratified log-rank test||||0.62|0.40|< 0.001
72448652|NCT03511664|144415017|SUPERIORITY||Cox Proportional Hazard|0.3|||<|0.001|TWO_SIDED|95.0|0.24|0.38|||Log Rank|Two-sided stratified log-rank test||||0.38|0.24|< 0.001
72448653|NCT03511664|144415019|SUPERIORITY||Odds Ratio (OR)|11.19|||<|0.001|TWO_SIDED|95.0|6.3|20.0|||Chi-squared|Two-sided Wald's Chi-square test (stratified)||||20.0|6.3|< 0.001
72448654|NCT03511664|144415020|SUPERIORITY||Odds Ratio (OR)|23.6|||<|0.001|TWO_SIDED|95.0|8.6|65.1|||Chi-squared|Two-sided Wald's Chi-square test (stratified)||||65.1|8.6|< 0.001
72448655|NCT03435614|144415105|OTHER||||||||||||||||||We selected the individual signs and symptoms associated with the presence of OIWS based on a difference of greater than 15 % in the assessments between the group with OIWS and the group not displaying OIWS. This 15 % difference was judged to be of clinical significance. The signs and symptoms which did not meet this difference were not considered (data not available).|||
72448656|NCT03526887|144415127|SUPERIORITY||Median Difference (Net)|9.7||||0.016|TWO_SIDED|95.0|9.4|19.1|||Log Rank|||||19.1|9.4|0.016
72448657|NCT06044090|144415275|SUPERIORITY|||||||0.856|||||||t-test, 2 sided|||||||0.856
72448658|NCT06044090|144415275|SUPERIORITY|||||||0.613|||||||t-test, 2 sided|||||||0.613
72448659|NCT06044090|144415276|SUPERIORITY|||||||1|||||||t-test, 2 sided|||||||1.000
72448660|NCT06044090|144415276|SUPERIORITY|||||||0.691|||||||t-test, 2 sided|||||||0.691
72448661|NCT06044090|144415277|SUPERIORITY|||||||0.225|||||||t-test, 2 sided|||||||0.225
72448662|NCT06044090|144415277|SUPERIORITY|||||||0.667|||||||t-test, 2 sided|||||||0.667
72619538|NCT00944645|144769948|NON_INFERIORITY_OR_EQUIVALENCE|Primary research hypothesis I: The Cmax of nicotinuric acid (NUA) following the administration of MK0524A (ER niacin 1000 mg/ laropiprant 20 mg) tablets from 2 manufacturing sites is similar (i.e., the true GMR of NUA Cmax is contained within the bioequivalence interval (0.80, 1.25)).|Geometric Mean Ratio|0.98||||||90.0|0.93|1.03||||||"MK0524A (1000 mg ER Niacin/20 mg MK-laropiprant) tablet from new manufacturing site (Source 2)~MK0524A (1000 mg ER Niacin/20 mg MK-laropiprant) Phase III tablet (Source 1)"||1.03|0.93|
72448663|NCT05698875|144415318|OTHER||Fixed effects parameter|1.0||||0.12|TWO_SIDED|95.0|0.1|1.9||P=0.04 however was adjusted using the Bonferroni correction The a priori threshold for statistical significance p\<0.05|Linear Mixed Model|||HGL vs control meals||1.9|0.1|0.12
72448664|NCT05698875|144415318|OTHER||Fixed effects parameter|-0.58||||0.23|TWO_SIDED|95.0|-1.5|0.4||The a priori threshold for statistical significance p\<0.05|Linear Mixed Model|||HGLP vs control meal||0.4|-1.5|0.23
72448665|NCT05698875|144415318|OTHER||Fixed effects parameter|0.24||||0.62|TWO_SIDED|95.0|-0.7|1.2||The a priori threshold for statistical significance p\<0.05|Linear Mixed Model|||MGL vs control meal||1.2|-0.7|0.62
72448666|NCT05698875|144415318|OTHER||Fixed effects parameter|1.6||||0.003|TWO_SIDED|95.0|0.7|2.5||Above is adjusted p value using Bonferroni correction. The a priori threshold for statistical significance p\<0.05|Linear Mixed Model|||HGL vs HGLP||2.5|0.7|0.003
72448667|NCT05698875|144415318|OTHER||Fixed effects parameter|0.82||||0.08|TWO_SIDED|95.0|-0.1|1.7||The a priori threshold for statistical significance p\<0.05|Linear Mixed Model|||HGL vs MGL meals||1.7|-0.1|0.08
72448668|NCT05698875|144415318|OTHER||Fixed effects parameter|-0.8||||0.12|TWO_SIDED|95.0|-1.7|0.2||The a priori threshold for statistical significance p\<0.05|Linear Mixed Model|||HGLP vs MGL meals||0.2|-1.7|0.12
72448669|NCT05698875|144415319|OTHER||Mean Difference (Final Values)|0.835||||0.08|TWO_SIDED|95.0|-0.1|1.8||The a priori threshold for statistical significance p\<0.05|Linear Mixed Model|||HGL vs control meals||1.8|-0.1|0.08
72448670|NCT05698875|144415319|OTHER||Mean Difference (Final Values)|-0.7||||0.13|TWO_SIDED|95.0|-1.7|0.2||The a priori threshold for statistical significance p\<0.05|Linear Mixed Model|||HGLP meal vs control meal||0.2|-1.7|0.13
72448671|NCT05698875|144415319|OTHER||Mean Difference (Final Values)|-0.2||||0.68|TWO_SIDED|95.0|-1.2|0.8||The a priori threshold for statistical significance p\<0.05|Linear Mixed Model|||MGL meals vs control meals||0.8|-1.2|0.68
72448672|NCT05698875|144415319|OTHER||Mean Difference (Final Values)|1.6|||<|0.01|TWO_SIDED|95.0|0.7|2.5||The a priori threshold for statistical significance p\<0.05 P value adjusted with Bonferroni correction|Linear Mixed Model|||HGL vs HGLP meals||2.5|0.7|<0.01
72448673|NCT05698875|144415319|OTHER||Mean Difference (Final Values)|1.1||||0.06|TWO_SIDED|95.0|0.2|2.0||The a priori threshold for statistical significance p\<0.05 p value adjusted with the Bonferroni correction|Linear Mixed Model|||HGL vs MGL meals||2.0|0.2|0.06
72448674|NCT05698875|144415319|OTHER||Mean Difference (Final Values)|-0.5||||0.29|TWO_SIDED|95.0|-1.4|0.4||a priori threshold for statistical significance - P\<0.05|Linear Mixed Model|||HGLP vs MGL meals||0.4|-1.4|0.29
72448675|NCT05698875|144415320|OTHER||Mean Difference (Final Values)|1.9|||<|0.01|TWO_SIDED|95.0|0.8|3.0||The a priori threshold for statistical significance p\<0.05 Adjusted p value with Bonferroni correction|Linear Mixed Model|||HGL meals vs control meals||3.0|0.8|<0.01
72448676|NCT05698875|144415320|OTHER||Mean Difference (Final Values)|-0.3||||0.59|TWO_SIDED|95.0|-1.4|0.8||A priori threshold for statistical significance is p\<0.05|Linear Mixed Model|||HGLP meals vs control meals||0.8|-1.4|0.59
72448677|NCT05698875|144415320|OTHER||Mean Difference (Final Values)|-0.1||||0.86|TWO_SIDED|95.0|-1.2|1.0||A priori threshold for statistical significance is p\<0.05|Linear Mixed Model|||MGL meals vs control meals||1.0|-1.2|0.86
72448678|NCT05698875|144415320|OTHER||Mean Difference (Final Values)|2.3|||<|0.001|TWO_SIDED|95.0|1.2|3.3||A priori threshold for statistical significance is p\<0.05 Adjustment with Bonferroni did not alter p value|Linear Mixed Model|||HGL vs HGLP meals||3.3|1.2|<0.001
72448679|NCT05698875|144415320|OTHER||Mean Difference (Final Values)|2.1|||<|0.001|TWO_SIDED|95.0|1.1|3.1||A priori threshold for statistical significance is p\<0.05 Adjustment with Bonferroni correction did not alter p value|Linear Mixed Model|||HGL vs MGL meals||3.1|1.1|<0.001
72448680|NCT05698875|144415320|OTHER||Mean Difference (Final Values)|-0.1||||0.79|TWO_SIDED|95.0|-1.2|0.9||A priori threshold for statistical significance is p\<0.05|Linear Mixed Model|||HGLP vs MGL meals||0.9|-1.2|0.79
72448681|NCT05698875|144415321|OTHER||Mean Difference (Final Values)|-8.5||||0.31|TWO_SIDED|95.0|-25.0|8.0||A priori threshold for statistical significance is p\<0.05|Linear Mixed Model|||HGL meals vs control meals||8|-25|0.31
72448682|NCT05698875|144415321|OTHER||Mean Difference (Final Values)|-24.4||||0.03|TWO_SIDED|95.0|-41.0|-8.0||A priori threshold for statistical significance is p\<0.05 P adjusted using Bonferroni correction|Linear Mixed Model|||HGLP meals vs control meals||-8|-41|0.03
72448683|NCT05698875|144415321|OTHER||Mean Difference (Final Values)|12.7||||0.14|TWO_SIDED|95.0|-4.1|29.5||A priori threshold for statistical significance is p\<0.05|Linear Mixed Model|||MGL meals vs control meals||29.5|-4.1|0.14
72448684|NCT05698875|144415321|OTHER||Mean Difference (Final Values)|17.0||||0.34|TWO_SIDED|95.0|3.1|31.7||A priori threshold P \<0.05 P value adjusted with Bonferroni correction|Linear Mixed Model|||HGL vs HGLP meals||31.7|3.1|0.34
72448685|NCT05698875|144415321|OTHER||Mean Difference (Final Values)|-19.0||||0.07|TWO_SIDED|95.0|-33.3|-4.7||A priori threshold for statistical significance is p\<0.05 Adjusted P value with Bonferroni correction|Linear Mixed Model|||HGL vs MGL meals||-4.7|-33.3|0.07
72448686|NCT05698875|144415321|OTHER||Mean Difference (Final Values)|-36.4|||<|0.001|TWO_SIDED|95.0|-51.0|-21.8||A priori threshold for statistical significance is p\<0.05 Adjustment with Bonferroni did not alter p value|Linear Mixed Model|||HGLP vs MGL meals||-21.8|-51.0|<0.001
72448687|NCT05698875|144415322|OTHER||Mean Difference (Final Values)|151.0||||0.25|TWO_SIDED|95.0|7.0|294.0||A priori threshold for statistical significance is p\<0.05 Adjusted p value with Bonferroni correction|Linear Mixed Model|||HGL meals vs control meals||294|7|0.25
72448688|NCT05698875|144415322|OTHER||Mean Difference (Final Values)|-109.0||||0.15|TWO_SIDED|95.0|-256.0|38.0||A priori threshold for statistical significance is p\<0.05|Linear Mixed Model|||HGLP meals vs control meals||38|-256|0.15
72448689|NCT05698875|144415322|OTHER||Mean Difference (Final Values)|-30.0||||0.69|TWO_SIDED|95.0|-177.0|117.0||A priori threshold for statistical significance is p\<0.05|Linear Mixed Model|||MGL meals vs control meals||117|-177|0.69
72561595|NCT02725411|144653874|OTHER|No formal hypotheses were tested in the study.|LS Mean Difference|-0.94|STANDARD_ERROR_OF_MEAN|0.4|||TWO_SIDED|95.0|-1.72|-0.15||||||Week 40: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.||-0.15|-1.72|
72448690|NCT05698875|144415322|OTHER||Mean Difference (Final Values)|264.0|||<|0.001|TWO_SIDED|95.0|126.0|401.0||A priori threshold for statistical significance is p\<0.05 Adjustment with Bonferroni did not alter p value|Linear Mixed Model|||HGL vs HGLP meals||401|126|<0.001
72448691|NCT05698875|144415322|OTHER||Mean Difference (Final Values)|192.0||||0.02|TWO_SIDED|95.0|56.0|329.0||A priori threshold for statistical significance is p\<0.05 P value adjusted with Bonferroni correction|Linear Mixed Model|||HGL vs MGL meals||329|56|0.02
72448692|NCT05698875|144415322|OTHER||Mean Difference (Final Values)|-71.0||||0.32|TWO_SIDED|95.0|-211.0|69.0||A priori threshold for statistical significance is p\<0.05|Linear Mixed Model|||HGLP vs MGL meals||69|-211|0.32
72448693|NCT05698875|144415323|OTHER||Mean Difference (Final Values)|6.9|||<|0.01|TWO_SIDED|95.0|3.3|10.4||A priori threshold for statistical significance is p\<0.05 P value adjusted with Bonferroni correction|Linear Mixed Model|||HGL meals vs control meals||10.4|3.3|<0.01
72448694|NCT05698875|144415323|OTHER||Mean Difference (Final Values)|3.5||||0.06|TWO_SIDED|95.0|-0.2|7.2||A priori threshold for statistical significance is p\<0.05|Linear Mixed Model|||HGLP meals vs control meals||7.2|-0.2|0.06
72448695|NCT05698875|144415323|OTHER||Mean Difference (Final Values)|0.32||||0.86|TWO_SIDED|95.0|-3.3|3.9||A priori threshold for statistical significance is p\<0.05|Linear Mixed Model|||MGL meals vs control meals||3.9|-3.3|0.86
72498598|NCT03371355|144527595|SUPERIORITY||Least Squares Mean Difference|0.57||||0.5299|TWO_SIDED|95.0|-1.24|2.39|||ANCOVA|||Weight||2.39|-1.24|0.5299
72498599|NCT03371355|144527595|SUPERIORITY||Least Squares Mean Difference|-0.12||||0.8919|TWO_SIDED|95.0|-1.89|1.65|||ANCOVA|||Weight||1.65|-1.89|0.8919
72561596|NCT02725411|144653874|OTHER|No formal hypotheses were tested in the study.|LS Mean Difference|-0.26|STANDARD_ERROR_OF_MEAN|0.41|||TWO_SIDED|95.0|-1.05|0.54||||||Week 40: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.||0.54|-1.05|
72448696|NCT05698875|144415323|OTHER||Mean Difference (Final Values)|3.4||||0.11|TWO_SIDED|95.0|0.24|6.48||A priori threshold for statistical significance is p\<0.05 P value adjusted with the Bonferroni correction|Linear Mixed Model|||HGL vs HGLP meals||6.48|0.24|0.11
72448697|NCT05698875|144415323|OTHER||Mean Difference (Final Values)|6.7|||<|0.001|TWO_SIDED|95.0|3.6|9.8||A priori threshold for statistical significance is p\<0.05 Adjustment with Bonferroni did not alter p value|Linear Mixed Model|||HGL vs MGL meals||9.8|3.6|<0.001
72448698|NCT05698875|144415323|OTHER||Mean Difference (Final Values)|3.3||||0.13|TWO_SIDED|95.0|0.2|6.5||A priori threshold for statistical significance is p\<0.05 Adjustment with Bonferroni correction|Linear Mixed Model|||HGLP vs MGL meals||6.5|0.2|0.13
72448699|NCT05698875|144415324|OTHER||Mean Difference (Final Values)|-34.8||||0.01|TWO_SIDED|95.0|-55.9|-13.6||A priori threshold for statistical significance is p\<0.05 Adjustment with Bonferroni correction|Linear Mixed Model|||HGL meals vs control meal||-13.6|-55.9|0.01
72448700|NCT05698875|144415324|OTHER||Mean Difference (Final Values)|-1.8||||0.87|TWO_SIDED|95.0|-23.6|19.9||A priori threshold for statistical significance is p\<0.05|Linear Mixed Model|||HGLP meals vs control meals||19.9|-23.6|0.87
72448701|NCT05698875|144415324|OTHER||Mean Difference (Final Values)|-4.7||||0.67|TWO_SIDED|95.0|-26.4|17.0||A priori threshold for statistical significance is p\<0.05|Linear Mixed Model|||MGL meals vs control meals||17.0|-26.4|0.67
72448702|NCT05698875|144415324|OTHER||Mean Difference (Final Values)|-33.3||||0.01|TWO_SIDED|95.0|-54.4|-12.2||A priori threshold for statistical significance is p\<0.05 Adjustment with Bonferroni correction|Linear Mixed Model|||HGL vs HGLP meals||-12.2|-54.4|0.01
72448703|NCT05698875|144415324|OTHER||Mean Difference (Final Values)|-31.4||||0.01|TWO_SIDED|95.0|-52.4|-10.4||A priori threshold for statistical significance is p\<0.05 Adjustment with Bonferroni correction|Linear Mixed Model|||HGL vs MGL meals||-10.4|-52.4|0.01
72448704|NCT05698875|144415324|OTHER||Mean Difference (Final Values)|1.86||||0.87|TWO_SIDED|95.0|-19.7|23.4||A priori threshold for statistical significance is p\<0.05|Linear Mixed Model|||HGLP vs MGL meals||23.4|-19.7|0.87
72448705|NCT05698875|144415325|OTHER||Mean Difference (Final Values)|34.0||||0.04|TWO_SIDED|95.0|2.0|65.0|||t-test, 2 sided|||Control vs HGL meals||65|2|0.04
72448706|NCT05698875|144415325|OTHER||Mean Difference (Final Values)|6.0||||0.56|TWO_SIDED|95.0|-17.0|30.0|||t-test, 2 sided|||Control vs HGLP meals||30|-17|0.56
72448707|NCT05698875|144415325|OTHER||Mean Difference (Final Values)|12.0||||0.22|TWO_SIDED|95.0|8.0|32.0|||t-test, 2 sided|||Control vs MGL meals||32|8|0.22
72448708|NCT05698875|144415325|OTHER||Mean Difference (Final Values)|38.0||||0.01|TWO_SIDED|95.0|10.0|67.0|||t-test, 2 sided|||HGL vs HGLP meals||67|10|0.01
72448709|NCT05698875|144415325|OTHER||Mean Difference (Final Values)|33.0||||0.03|TWO_SIDED|95.0|4.0|62.0|||t-test, 2 sided|||HGL vs MGL meals||62|4|0.03
72448710|NCT05698875|144415325|OTHER||Mean Difference (Final Values)|-5.0||||0.63|TWO_SIDED|95.0|-29.0|18.0|||t-test, 2 sided|||HGLP vs MGL meals||18|-29|0.63
72448711|NCT05698875|144415326|OTHER||Mean Difference (Final Values)|22.0||||0.16|TWO_SIDED|95.0|10.0|53.0|||t-test, 2 sided|||Control vs HGL meals||53|10|0.16
72448712|NCT05698875|144415326|OTHER||Mean Difference (Final Values)|21.0||||0.11|TWO_SIDED|95.0|5.0|46.0|||t-test, 2 sided|||Control vs HGLP meals||46|5|0.11
72448713|NCT05698875|144415326|OTHER||Mean Difference (Final Values)|19.0||||0.15|TWO_SIDED|95.0|8.0|45.0|||t-test, 2 sided|||Control vs MGL meals||45|8|0.15
72498600|NCT03371355|144527595|SUPERIORITY||Least Squares Mean Difference|-0.4||||0.6653|TWO_SIDED|95.0|-2.25|1.44|||ANCOVA|||Weight||1.44|-2.25|0.6653
72498601|NCT03371355|144527595|SUPERIORITY||Least Squares Mean Difference|2.35||||0.4213|TWO_SIDED|95.0|-3.43|8.14|||ANCOVA|||SBP||8.14|-3.43|0.4213
72561597|NCT02725411|144653874|OTHER|No formal hypotheses were tested in the study.|LS Mean Difference|-0.97|STANDARD_ERROR_OF_MEAN|0.42|||TWO_SIDED|95.0|-1.8|-0.15||||||Week 48: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.||-0.15|-1.80|
72498602|NCT03371355|144527595|SUPERIORITY||Least Squares Mean Difference|1.23||||0.6696|TWO_SIDED|95.0|-4.49|6.96|||ANCOVA|||SBP||6.96|-4.49|0.6696
72498603|NCT03371355|144527595|SUPERIORITY||Least Squares Mean Difference|-1.23||||0.6819|TWO_SIDED|95.0|-7.2|4.73|||ANCOVA|||SBP||4.73|-7.20|0.6819
72561598|NCT02725411|144653874|OTHER|No formal hypotheses were tested in the study.|LS Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.42|||TWO_SIDED|95.0|-1.04|0.61||||||Week 48: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.||0.61|-1.04|
72448714|NCT05698875|144415326|OTHER||Mean Difference (Final Values)|44.0|||<|0.01|TWO_SIDED|95.0|16.0|71.0|||t-test, 2 sided|||HGL vs HGLP meals||71|16|<0.01
72448715|NCT05698875|144415326|OTHER||Mean Difference (Final Values)|-7.0||||0.6|TWO_SIDED|95.0|-36.0|21.0|||t-test, 2 sided|||HGL vs MGL meals||21|-36|0.60
72448716|NCT05698875|144415326|OTHER||Mean Difference (Final Values)|29.0||||0.02|TWO_SIDED|95.0|6.0|51.0|||t-test, 2 sided|||HGLP vs MGL meals||51|6|0.02
72448717|NCT05698875|144415327|OTHER||Mean Difference (Final Values)|1.6|||<|0.001|TWO_SIDED|95.0|0.8|2.4||The a priori threshold for statistical significance p\<0.05|Linear Mixed Model|||HGL meal excursion vs Control meal at 30 minutes||2.4|0.8|<0.001
72448718|NCT05698875|144415327|OTHER||Mean Difference (Final Values)|0.4||||0.38|TWO_SIDED|95.0|-0.5|1.2|||Linear Mixed Model|||HGLP meal vs Control meal glucose excursion at 30 minutes||1.2|-0.5|0.38
72448719|NCT05698875|144415327|OTHER||Mean Difference (Final Values)|-0.3||||0.47|TWO_SIDED|95.0|-1.1|0.5||a priori threshold for statistical significance p\<0.05|Linear Mixed Model|||MGL meal excursion vs Control meal at 30 minutes||0.5|-1.1|0.47
72448720|NCT05698875|144415327|OTHER||Mean Difference (Final Values)|1.2||||0.01|TWO_SIDED|95.0|0.5|2.0||a priori threshold for statistical significance p\<0.05 P value adjusted with Bonferroni correction|Linear Mixed Model|||HGL meal vs HGLP meal||2.0|0.5|0.01
72498604|NCT03371355|144527595|SUPERIORITY||Least Squares Mean Difference|5.01||||0.1171|TWO_SIDED|95.0|-1.28|11.31|||ANCOVA|||DBP||11.31|-1.28|0.1171
72498605|NCT03371355|144527595|SUPERIORITY||Least Squares Mean Difference|3.94||||0.2155|TWO_SIDED|95.0|-2.33|10.21|||ANCOVA|||DBP||10.21|-2.33|0.2155
72561599|NCT02725411|144653874|OTHER|No formal hypotheses were tested in the study.|LS Mean Difference|-0.85|STANDARD_ERROR_OF_MEAN|0.41|||TWO_SIDED|95.0|-1.65|-0.05||||||Week 56: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.||-0.05|-1.65|
72448721|NCT05698875|144415327|OTHER||Mean Difference (Final Values)|1.9|||<|0.001|TWO_SIDED|95.0|1.1|2.6||a priori threshold for statistical significance p\<0.05|Linear Mixed Model|||HGL meal vs MGL meals||2.6|1.1|<0.001
72448722|NCT05698875|144415327|OTHER||Mean Difference (Final Values)|0.7||||0.09|TWO_SIDED|95.0|0.1|1.4||a priori threshold for statistical significance p\<0.05|Linear Mixed Model|||HGLP meals vs MGL meals||1.4|0.1|0.09
72448723|NCT05698875|144415328|OTHER||Mean Difference (Final Values)|1.9|||<|0.001|TWO_SIDED|95.0|0.7|3.0||a priori threshold for statistical significance p\<0.05|Linear Mixed Model|||HGL meals vs control meals||3.0|0.7|<0.001
72448724|NCT05698875|144415328|OTHER||Mean Difference (Final Values)|-0.1||||0.87|TWO_SIDED|95.0|-1.2|1.0||a priori threshold for statistical significance p\<0.05|Linear Mixed Model|||HGLP meals vs control meals||1.0|-1.2|0.87
72448725|NCT05698875|144415328|OTHER||Mean Difference (Final Values)|-0.4||||0.48|TWO_SIDED|95.0|-1.5|0.7||a priori threshold for statistical significance p\<0.05|Linear Mixed Model|||MGL meals vs control meals||0.7|-1.5|0.48
72498606|NCT03371355|144527595|SUPERIORITY||Least Squares Mean Difference|1.7||||0.6034|TWO_SIDED|95.0|-4.79|8.2|||ANCOVA|||DBP||8.20|-4.79|0.6034
72448726|NCT05698875|144415328|OTHER||Mean Difference (Final Values)|2.0|||<|0.001|TWO_SIDED|95.0|1.0|3.1||a priori threshold for statistical significance p\<0.05|Linear Mixed Model|||HGL meals vs HGLP meals||3.1|1.0|<0.001
72448727|NCT05698875|144415328|OTHER||Mean Difference (Final Values)|2.4|||<|0.001|TWO_SIDED|95.0|1.3|3.4||a priori threshold for statistical significance p\<0.05|Linear Mixed Model|||HGL meals vs MGL meals||3.4|1.3|<0.001
72448728|NCT05698875|144415328|OTHER||Mean Difference (Final Values)|-0.34||||0.53|TWO_SIDED|95.0|-1.4|0.7||a priori threshold for statistical significance p\<0.05|Linear Mixed Model|||MGL meals vs HGLP meals||0.7|-1.4|0.53
72448729|NCT05698875|144415329|OTHER||Mean Difference (Final Values)|1.3||||0.06|TWO_SIDED|95.0|-0.03|2.7||a priori threshold for statistical significance p\<0.05|Linear Mixed Model|||HGL meals vs control meals||2.7|-0.03|0.06
72448730|NCT05698875|144415329|OTHER||Mean Difference (Final Values)|-1.1||||0.13|TWO_SIDED|95.0|-2.5|0.3||a priori threshold for statistical significance p\<0.05|Linear Mixed Model|||HGLP meals vs control meals||0.3|-2.5|0.13
72448731|NCT05698875|144415329|OTHER||Mean Difference (Final Values)|-0.2||||0.82|TWO_SIDED|95.0|-1.5|1.2||a priori threshold for statistical significance p\<0.05|Linear Mixed Model|||MGL meals vs control meals||1.2|-1.5|0.82
72498607|NCT03371355|144527596|SUPERIORITY||Least Squares Mean Difference|0.98||||0.5752|TWO_SIDED|95.0|-2.48|4.44|||ANCOVA|||||4.44|-2.48|0.5752
72498608|NCT03371355|144527596|SUPERIORITY||Least Squares Mean Difference|4.09||||0.023|TWO_SIDED|95.0|0.58|7.59|||ANCOVA|||||7.59|0.58|0.0230
72498609|NCT03371355|144527596|SUPERIORITY||Least Squares Mean Difference|1.57||||0.3965|TWO_SIDED|95.0|-2.1|5.25|||ANCOVA|||||5.25|-2.10|0.3965
72498610|NCT03371355|144527597|SUPERIORITY||Least Squares Mean Difference|12.44||||0.3023|TWO_SIDED|95.0|-11.39|36.26|||ANCOVA|||||36.26|-11.39|0.3023
72498611|NCT03371355|144527597|SUPERIORITY||Least Squares Mean Difference|26.03||||0.035|TWO_SIDED|95.0|1.87|50.19|||ANCOVA|||||50.19|1.87|0.0350
72498612|NCT03371355|144527597|SUPERIORITY||Least Squares Mean Difference|12.27||||0.3374|TWO_SIDED|95.0|-13.02|37.55|||ANCOVA|||||37.55|-13.02|0.3374
72561600|NCT02725411|144653874|OTHER|No formal hypotheses were tested in the study.|LS Mean Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.41|||TWO_SIDED|95.0|-0.88|0.71||||||Week 56: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.||0.71|-0.88|
72448732|NCT05698875|144415329|OTHER||Mean Difference (Final Values)|2.4|||<|0.01|TWO_SIDED|95.0|1.1|3.7||a priori threshold for statistical significance p\<0.05 Adjusted with Bonferroni correction|Linear Mixed Model|||HGL meals vs MGL meals||3.7|1.1|<0.01
72448733|NCT05698875|144415329|OTHER||Mean Difference (Final Values)|1.5||||0.08|TWO_SIDED|95.0|0.2|2.9||a priori threshold for statistical significance p\<0.05 Adjusted with Bonferroni correction|Linear Mixed Model|||HGL meals vs MGL meals||2.9|0.2|0.08
72448734|NCT05698875|144415329|OTHER||Mean Difference (Final Values)|0.9||||0.21|TWO_SIDED|95.0|-0.5|2.2||a priori threshold for statistical significance p\<0.05|Linear Mixed Model|||MGL meals vs HGLP meals||2.2|-0.5|0.21
72448735|NCT05698875|144415330|OTHER||Mean Difference (Final Values)|0.8||||0.31|TWO_SIDED|95.0|-0.7|2.2||a priori threshold for statistical significance p\<0.05|Linear Mixed Model|||HGL meals vs control meals||2.2|-0.7|0.31
72448736|NCT05698875|144415330|OTHER||Mean Difference (Final Values)|-1.5||||0.05|TWO_SIDED|95.0|-3.0|-0.1||a priori threshold for statistical significance p\<0.05|Linear Mixed Model|||HGLP meals vs control meals||-0.1|-3.0|0.05
72448737|NCT05698875|144415330|OTHER||Mean Difference (Final Values)|0.03||||0.97|TWO_SIDED|95.0|-1.5|1.5||a priori threshold for statistical significance p\<0.05|Linear Mixed Model|||MGL meals vs control meals||1.5|-1.5|0.97
72448738|NCT05698875|144415330|OTHER||Mean Difference (Final Values)|2.3|||<|0.01|TWO_SIDED|95.0|1.0|3.6||a priori threshold for statistical significance p\<0.05 Adjusted with Bonferroni correction|Linear Mixed Model|||HGL meals vs HGLP meals||3.6|1.0|<0.01
72448739|NCT05698875|144415330|OTHER||Mean Difference (Final Values)|0.8||||0.27|TWO_SIDED|95.0|0.6|2.2||a priori threshold for statistical significance p\<0.05|Linear Mixed Model|||HGL meals vs MGL meals||2.2|0.6|0.27
72448740|NCT05698875|144415330|OTHER||Mean Difference (Final Values)|1.5||||0.12|TWO_SIDED|95.0|0.1|3.0||a priori threshold for statistical significance \<0.05 Adjusted with p value|Linear Mixed Model|||MGL meals vs HGLP meals||3.0|0.1|0.12
72448741|NCT05698875|144415331|OTHER||Mean Difference (Final Values)|-0.2||||0.83|TWO_SIDED|95.0|-1.5|1.2||a priori threshold for statistical significance \<0.05|Linear Mixed Model|||HGL meals vs control meals||1.2|-1.5|0.83
72448742|NCT05698875|144415331|OTHER||Mean Difference (Final Values)|-1.5||||0.09|TWO_SIDED|95.0|-2.9|-0.2||a priori threshold for statistical significance \<0.05 Adjusted with Bonferroni correction|Linear Mixed Model|||HGLP meals vs control meals||-0.2|-2.9|0.09
72448743|NCT05698875|144415331|OTHER||Mean Difference (Final Values)|-0.2||||0.78|TWO_SIDED|95.0|-1.6|1.2||a priori threshold for statistical significance \<0.05|Linear Mixed Model|||MGL meals vs control meals||1.2|-1.6|0.78
72448744|NCT05698875|144415331|OTHER||Mean Difference (Final Values)|1.4||||0.11|TWO_SIDED|95.0|0.1|2.7||a priori threshold for statistical significance \<0.05 Adjusted with Bonferroni correction|Linear Mixed Model|||HGL meals vs HGLP meals||2.7|0.1|0.11
72448745|NCT05698875|144415331|OTHER||Mean Difference (Final Values)|-0.2||||0.82|TWO_SIDED|95.0|-1.5|1.1||a priori threshold for statistical significance \<0.05|Linear Mixed Model|||MGL meals vs HGL meals||1.1|-1.5|0.82
72448746|NCT05698875|144415331|OTHER||Mean Difference (Final Values)|1.3||||0.06|TWO_SIDED|95.0|-0.1|2.6||a priori threshold for statistical significance \<0.05|Linear Mixed Model|||MGL meals vs HGLP meals||2.6|-0.1|0.06
72448747|NCT05698875|144415332|OTHER||Mean Difference (Final Values)|0.1||||0.85|TWO_SIDED|95.0|-1.1|1.3||a priori threshold for statistical significance \<0.05|Linear Mixed Model|||HGL meals vs control meals||1.3|-1.1|0.85
72448748|NCT05698875|144415332|OTHER||Mean Difference (Final Values)|-1.2||||0.06|TWO_SIDED|95.0|-2.4|0.04||a priori threshold for statistical significance \<0.05|Linear Mixed Model|||HGLP meals vs control meals||0.04|-2.4|0.06
72498613|NCT03371355|144527599|SUPERIORITY||Least Squares Mean Difference|-2.59||||0.4583|TWO_SIDED|95.0|-9.49|4.31|||ANCOVA|||||4.31|-9.49|0.4583
72448749|NCT05698875|144415332|OTHER||Mean Difference (Final Values)|-0.08||||0.9|TWO_SIDED|95.0|-1.3|1.2||a priori threshold for statistical significance \<0.05|Linear Mixed Model|||MGL meals vs control meals||1.2|-1.3|0.90
72448750|NCT05698875|144415332|OTHER||Mean Difference (Final Values)|1.4||||0.05|TWO_SIDED|95.0|0.3|2.5||a priori threshold for statistical significance \<0.05 Adjusted with Bonferroni correction|Linear Mixed Model|||HGL meals vs HGLP meals||2.5|0.3|0.05
72448751|NCT05698875|144415332|OTHER||Mean Difference (Final Values)|0.34||||0.55|TWO_SIDED|95.0|-0.8|1.5||a priori threshold for statistical significance \<0.05|Linear Mixed Model|||HGL meals vs MGL meals||1.5|-0.8|0.55
72448752|NCT05698875|144415332|OTHER||Mean Difference (Final Values)|1.1||||0.08|TWO_SIDED|95.0|-0.1|2.2||a priori threshold for statistical significance \<0.05|Linear Mixed Model|||MGL meals vs HGLP meals||2.2|-0.1|0.08
72448753|NCT03974178|144415390|OTHER|"The minimal sample size to get a possible rejection of H0 (pdeath = 8.5% or more) in favour of H1 (pdeath \<8.5%) was 34 evaluable patients with stage 2 r-HAT.~The hypothesis was tested with a one-sided exact test for proportions at the 0.05 significance level."|Fatality rate|0.0||||0.0488|TWO_SIDED|90.0|0.0|8.43||The rate of deaths possibly related to r-HAT or to fexinidazole at the end of hospitalization was compared to the predefined unacceptable rate of 8.5%.|one-sided exact test|Clopper Pearson exact method||"The proportion of deaths (pdeath) is compared to the threshold of 8.5%, with H0 being pdeath = 8.5% or more.~The 90% confidence interval of the fatality rate is calculated with the Clopper-Pearson method."||8.43|0|0.0488
72448754|NCT03974178|144415391|OTHER|The hypothesis H0 (pfailure at the end of hospitalization = 9% or more) was tested with a one-sided exact test for proportions at the 0.05 significance level.|Failure rate|0.0||||0.0405|TWO_SIDED|90.0|0.0|8.43||The rate of failures at the end of hospitalization was compared to the predefined unacceptable rate of 9%.|one-sided exact test|Clopper Pearson exact method||"The proportion of failures at the end of hospitalization (pfailure) is compared to the threshold of 9%, with H0 being pfailure = 9% or more.~The 90% confidence interval of the failure rate is calculated with the Clopper-Pearson method."||8.43|0|0.0405
72498614|NCT03371355|144527599|SUPERIORITY||Least Squares Mean Difference|-5.71||||0.0943|TWO_SIDED|95.0|-12.43|1.0|||ANCOVA|||||1.00|-12.43|0.0943
72498615|NCT03371355|144527599|SUPERIORITY||Least Squares Mean Difference|-4.57||||0.1909|TWO_SIDED|95.0|-11.45|2.32|||ANCOVA|||||2.32|-11.45|0.1909
72498616|NCT03371355|144527600|SUPERIORITY||Least Squares Mean Difference|7.1||||0.1294|TWO_SIDED|95.0|-2.1|16.22|||ANCOVA|||ALT||16.22|-2.10|0.1294
72561601|NCT02725411|144653876|OTHER|No formal hypotheses were tested in the study.|LS Mean Difference|-0.86|STANDARD_ERROR_OF_MEAN|0.46|||TWO_SIDED|95.0|-1.77|0.04||||||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ as covariates, and study site as a random effect.||0.04|-1.77|
72561602|NCT02725411|144653876|OTHER|No formal hypotheses were tested in the study.|LS Mean Difference|-1.05|STANDARD_ERROR_OF_MEAN|0.46|||TWO_SIDED|95.0|-1.96|-0.14||||||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ as covariates, and study site as a random effect.||-0.14|-1.96|
72561603|NCT02725411|144653876|OTHER|No formal hypotheses were tested in the study.|LS Mean Difference|-0.52|STANDARD_ERROR_OF_MEAN|0.49|||TWO_SIDED|95.0|-1.48|0.43||||||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ as covariates, and study site as a random effect.||0.43|-1.48|
72561604|NCT02725411|144653876|OTHER|No formal hypotheses were tested in the study.|LS Mean Difference|-0.46|STANDARD_ERROR_OF_MEAN|0.5|||TWO_SIDED|95.0|-1.43|0.51||||||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ as covariates, and study site as a random effect.||0.51|-1.43|
72561605|NCT02725411|144653876|OTHER|No formal hypotheses were tested in the study.|LS Mean Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.5|||TWO_SIDED|95.0|-1.04|0.91||||||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ as covariates, and study site as a random effect.||0.91|-1.04|
72561606|NCT02725411|144653876|OTHER|No formal hypotheses were tested in the study.|LS Mean Difference|-0.55|STANDARD_ERROR_OF_MEAN|0.5|||TWO_SIDED|95.0|-1.53|0.44||||||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ as covariates, and study site as a random effect.||0.44|-1.53|
72561607|NCT02725411|144653876|OTHER|No formal hypotheses were tested in the study.|LS Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.54|||TWO_SIDED|95.0|-1.06|1.05||||||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ as covariates, and study site as a random effect.||1.05|-1.06|
72561608|NCT02725411|144653876|OTHER|No formal hypotheses were tested in the study.|LS Mean Difference|-0.53|STANDARD_ERROR_OF_MEAN|0.54|||TWO_SIDED|95.0|-1.6|0.53||||||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ as covariates, and study site as a random effect.||0.53|-1.60|
72561609|NCT02725411|144653876|OTHER|No formal hypotheses were tested in the study.|LS Mean Difference|-0.42|STANDARD_ERROR_OF_MEAN|0.66|||TWO_SIDED|95.0|-1.71|0.88||||||Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ as covariates, and study site as a random effect.||0.88|-1.71|
72561610|NCT02725411|144653876|OTHER|No formal hypotheses were tested in the study.|LS Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.66|||TWO_SIDED|95.0|-1.47|1.14||||||Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ as covariates, and study site as a random effect.||1.14|-1.47|
72498617|NCT03371355|144527600|SUPERIORITY||Least Squares Mean Difference|14.8||||0.0012|TWO_SIDED|95.0|5.98|23.59|||ANCOVA|||ALT||23.59|5.98|0.0012
72561611|NCT02725411|144653876|OTHER|No formal hypotheses were tested in the study.|LS Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.67|||TWO_SIDED|95.0|-1.9|0.71||||||Week 32: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ as covariates, and study site as a random effect.||0.71|-1.90|
72498618|NCT03371355|144527600|SUPERIORITY||Least Squares Mean Difference|8.9||||0.0594|TWO_SIDED|95.0|-0.36|18.11|||ANCOVA|||ALT||18.11|-0.36|0.0594
72498619|NCT03371355|144527600|SUPERIORITY||[Least Squares Mean Difference|5.0||||0.073|TWO_SIDED|95.0|-0.47|10.45|||ANCOVA|||AST||10.45|-0.47|0.0730
72561612|NCT02725411|144653876|OTHER|No formal hypotheses were tested in the study.|LS Mean Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.69|||TWO_SIDED|95.0|-1.44|1.25||||||Week 32: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ as covariates, and study site as a random effect.||1.25|-1.44|
72561613|NCT02725411|144653876|OTHER|No formal hypotheses were tested in the study.|LS Mean Difference|-1.08|STANDARD_ERROR_OF_MEAN|0.69|||TWO_SIDED|95.0|-2.43|0.28||||||Week 40: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ as covariates, and study site as a random effect.||0.28|-2.43|
72561614|NCT02725411|144653876|OTHER|No formal hypotheses were tested in the study.|LS Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.7|||TWO_SIDED|95.0|-1.41|1.32||||||Week 40: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ as covariates, and study site as a random effect.||1.32|-1.41|
72561615|NCT02725411|144653876|OTHER|No formal hypotheses were tested in the study.|LS Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.7|||TWO_SIDED|95.0|-2.17|0.57||||||Week 48: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ as covariates, and study site as a random effect.||0.57|-2.17|
72561616|NCT02725411|144653876|OTHER|No formal hypotheses were tested in the study.|LS Mean Difference|0.24|STANDARD_ERROR_OF_MEAN|0.71|||TWO_SIDED|95.0|-1.16|1.64||||||Week 48: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ as covariates, and study site as a random effect.||1.64|-1.16|
72448755|NCT03974178|144415392|OTHER|The hypothesis H0 (pfailure at 12 months = 12% or more) was tested with a one-sided exact test for proportions at the 0.05 significance level.|Failure rate|2.94||||0.073|TWO_SIDED|90.0|0.15|13.21||The rate of failures at 12 months was compared to the predefined unacceptable rate of 12%.|one-sided exact test|Clopper Pearson exact method||"The proportion of failures at 12 months (pfailure) is compared to the threshold of 12%, with H0 being pfailure = 12% or more.~The 90% confidence interval of the failure rate is calculated with the Clopper-Pearson method."||13.21|0.15|0.0730
72448756|NCT03974178|144415395|OTHER|The hypothesis H0 (pdeath = 8.5% or more) was tested with a one-sided exact test for proportions at the 0.05 significance level.|Fatality rate|0.0||||0.0201|TWO_SIDED|90.0|0.0|6.58||The rate of deaths possibly related to r-HAT or to fexinidazole at the end of hospitalization was compared to the predefined unacceptable rate of 8.5%.|one-sided exact test|Clopper Pearson exact method||"The proportion of deaths (pdeath) is compared to the threshold of 8.5%, with H0 being pdeath = 8.5% or more.~The 90% confidence interval of the fatality rate is calculated with the Clopper-Pearson method."||6.58|0|0.0201
72448757|NCT03974178|144415396|OTHER|The hypothesis H0 (pfailure at the end of hospitalization = 9% or more) was tested with a one-sided exact test for proportions at the 0.05 significance level.|Failure rate|0.0||||0.0158|TWO_SIDED|90.0|0.0|6.58||The rate of failures at the end of hospitalization was compared to the predefined unacceptable rate of 9%.|one-sided exact test|Clopper Pearson exact method||"The proportion of failures at the end of hospitalization (pfailure) is compared to the threshold of 9%, with H0 being pfailure = 9% or more.~The 90% confidence interval of the failure rate is calculated with the Clopper-Pearson method."||6.58|0|0.0158
72448758|NCT03974178|144415397|OTHER|The hypothesis H0 (pfailure at 12 months = 12% or more) was tested with a one-sided exact test for proportions at the 0.05 significance level.|Failure rate|2.27||||0.0253|TWO_SIDED|90.0|0.12|10.34||The rate of failures at 12 months was compared to the predefined unacceptable rate of 12%.|one-sided exact test|Clopper Pearson exact method||"The proportion of failures at 12 months (pfailure) is compared to the threshold of 12%, with H0 being pfailure = 12% or more.~The 90% confidence interval of the failure rate is calculated with the Clopper-Pearson method."||10.34|0.12|0.0253
72448759|NCT04508309|144415410|NON_INFERIORITY|Non-inferiority was to be demonstrated if the lower bound of the 98.3% confidence interval of the geometric mean concentration (GMC) ratio was greater than the non-inferiority margin of 0.5 for both HPV-16 and HPV-18.|GMC Ratio|1.09|||||TWO_SIDED|98.3|0.891|1.327|||||GMC ratios (Cecolin/Gardasil) and corresponding confidence limits were calculated using linear models of the log concentration values adjusted by site and transformed back to the original scale.|The primary objective included three non-inferiority comparisons of Cecolin at 0 and 6 months, 0 and 12 months, or 0 and 24 months compared to Gardasil at 0 and 6 months. To control the type I error for the three co-primary non-inferiority hypotheses, a Bonferroni correction corresponding to 98.3% confidence intervals (CI) was used.||1.327|0.891|
72448760|NCT04508309|144415410|NON_INFERIORITY|Non-inferiority was to be demonstrated if the lower bound of the 98.3% confidence interval of the GMC ratio was greater than the non-inferiority margin of 0.5 for both HPV-16 and HPV-18.|GMC Ratio|1.78|||||TWO_SIDED|98.3|1.455|2.176|||||GMC ratio (Cecolin/Gardasil) and corresponding confidence limits were calculated using linear models of the log concentration values adjusted by site and transformed back to the original scale.|The primary objective included three non-inferiority comparisons of Cecolin at 0 and 6 months, 0 and 12 months, or 0 and 24 months compared to Gardasil at 0 and 6 months. To control the type I error for the three co-primary non-inferiority hypotheses, a Bonferroni correction corresponding to 98.3% CI was used.||2.176|1.455|
72448761|NCT04508309|144415410|NON_INFERIORITY|Non-inferiority was to be demonstrated if the lower bound of the 98.3% confidence interval of the geometric mean concentration (GMC) ratio was greater than the non-inferiority margin of 0.5 for both HPV-16 and HPV-18.|GMC Ratio|2.37|||||TWO_SIDED|98.3|1.942|2.903|||||GMC ratios (Cecolin/Gardasil) and corresponding confidence limits were calculated using linear models of the log concentration values adjusted by site and transformed back to the original scale.|The primary objective included three non-inferiority comparisons of Cecolin at 0 and 6 months, 0 and 12 months, or 0 and 24 months compared to Gardasil at 0 and 6 months. To control the type I error for the three co-primary non-inferiority hypotheses, a Bonferroni correction corresponding to 98.3% confidence intervals (CI) was used.||2.903|1.942|
72448762|NCT04508309|144415411|NON_INFERIORITY|Non-inferiority was to be demonstrated if the lower bound of the 98.3% confidence interval of the geometric mean concentration (GMC) ratio was greater than the non-inferiority margin of 0.5 for both HPV-16 and HPV-18.|GMC Ratio|1.25|||||TWO_SIDED|98.3|1.022|1.539|||||GMC ratios (Cecolin/Gardasil) and corresponding confidence limits were calculated using linear models of the log concentration values adjusted by site and transformed back to the original scale.|The primary objective included three non-inferiority comparisons of Cecolin at 0 and 6 months, 0 and 12 months, or 0 and 24 months compared to Gardasil at 0 and 6 months. To control the type I error for the three co-primary non-inferiority hypotheses, a Bonferroni correction corresponding to 98.3% confidence intervals (CI) was used.||1.539|1.022|
72448763|NCT04508309|144415411|NON_INFERIORITY|Non-inferiority was to be demonstrated if the lower bound of the 98.3% confidence interval of the geometric mean concentration (GMC) ratio was greater than the non-inferiority margin of 0.5 for both HPV-16 and HPV-18.|GMC Ratio|1.68|||||TWO_SIDED|98.3|1.372|2.069|||||GMC ratios (Cecolin/Gardasil) and corresponding confidence limits were calculated using linear models of the log concentration values adjusted by site and transformed back to the original scale.|The primary objective included three non-inferiority comparisons of Cecolin at 0 and 6 months, 0 and 12 months, or 0 and 24 months compared to Gardasil at 0 and 6 months. To control the type I error for the three co-primary non-inferiority hypotheses, a Bonferroni correction corresponding to 98.3% confidence intervals (CI) was used.||2.069|1.372|
72498620|NCT03371355|144527600|SUPERIORITY||Least Squares Mean Difference|8.4||||0.002|TWO_SIDED|95.0|3.17|13.7|||ANCOVA|||AST||13.70|3.17|0.0020
72498621|NCT03371355|144527600|SUPERIORITY||Least Squares Mean Difference|6.5||||0.02|TWO_SIDED|95.0|1.05|12.0|||ANCOVA|||AST||12.00|1.05|0.0200
72498622|NCT03371355|144527601|SUPERIORITY||Least Squares Mean Difference|-1.19||||0.4812|TWO_SIDED|95.0|-4.55|2.16|||ANCOVA|||||2.16|-4.55|0.4812
72448764|NCT04508309|144415411|NON_INFERIORITY|Non-inferiority was to be demonstrated if the lower bound of the 98.3% confidence interval of the geometric mean concentration (GMC) ratio was greater than the non-inferiority margin of 0.5 for both HPV-16 and HPV-18.|GMC Ratio|1.71|||||TWO_SIDED|98.3|1.389|2.102|||||GMC ratios (Cecolin/Gardasil) and corresponding confidence limits were calculated using linear models of the log concentration values adjusted by site and transformed back to the original scale.|The primary objective included three non-inferiority comparisons of Cecolin at 0 and 6 months, 0 and 12 months, or 0 and 24 months compared to Gardasil at 0 and 6 months. To control the type I error for the three co-primary non-inferiority hypotheses, a Bonferroni correction corresponding to 98.3% confidence intervals (CI) was used.||2.102|1.389|
72448765|NCT04508309|144415416|NON_INFERIORITY|Non-inferiority of the Cecolin containing arm (Group 5) compared to Gardasil at months 0 and 6 (Group 4) was to be demonstrated if the lower limit of the 95% CI of the GMC ratio was greater than the non-inferiority margin of 0.5 for both HPV-16 and HPV-18.|GMC Ratio|1.75|||||TWO_SIDED|95.0|1.476|2.071|||||GMC ratio (Cecolin containing arm (Group 5)/Gardasil (Group 4)) and corresponding confidence limits were calculated using linear models of the log concentration values adjusted by site and transformed back to the original scale.|||2.071|1.476|
72561617|NCT02725411|144653876|OTHER|No formal hypotheses were tested in the study.|LS Mean Difference|-1.01|STANDARD_ERROR_OF_MEAN|0.69|||TWO_SIDED|95.0|-2.37|0.35||||||Week 56: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ as covariates, and study site as a random effect.||0.35|-2.37|
72561618|NCT02725411|144653876|OTHER|No formal hypotheses were tested in the study.|LS Mean Difference|0.03|STANDARD_ERROR_OF_MEAN|0.71|||TWO_SIDED|95.0|-1.35|1.42||||||Week 56: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ as covariates, and study site as a random effect.||1.42|-1.35|
72561619|NCT02725411|144653880|OTHER|No formal hypotheses were tested in the study.|Difference in Percentage of Participants|13.0|||||TWO_SIDED|95.0|-0.8|26.3||||||Week 16: \>=30%||26.3|-0.8|
72561620|NCT02725411|144653880|OTHER|No formal hypotheses were tested in the study.|Difference in Percentage of Participants|-1.7|||||TWO_SIDED|95.0|-15.8|12.4||||||Week 16: \>=30%||12.4|-15.8|
72561621|NCT02725411|144653880|OTHER|No formal hypotheses were tested in the study.|Difference in Percentage of Participants|18.5|||||TWO_SIDED|95.0|4.2|32.0||||||Week 16: \>=50%||32.0|4.2|
72561622|NCT02725411|144653880|OTHER|No formal hypotheses were tested in the study.|Difference in Percentage of Participants|2.9|||||TWO_SIDED|95.0|-10.7|16.3||||||Week 16: \>=50%||16.3|-10.7|
72561623|NCT02725411|144653880|OTHER|No formal hypotheses were tested in the study.|Difference in Percentage of Participants|10.9|||||TWO_SIDED|95.0|0.6|20.7||||||Week 16: \>=70%||20.7|0.6|
72561624|NCT02725411|144653880|OTHER|No formal hypotheses were tested in the study.|Difference in Percentage of Participants|8.5|||||TWO_SIDED|95.0|-1.4|18.1||||||Week 16: \>=70%||18.1|-1.4|
72448766|NCT04508309|144415417|NON_INFERIORITY|Non-inferiority of the Cecolin containing arm (Group 5) compared to Gardasil at months 0 and 6 (Group 4) was to be demonstrated if the lower limit of the 95% CI of the GMC ratio was greater than the non-inferiority margin of 0.5 for both HPV-16 and HPV-18.|GMC Ratio|1.21|||||TWO_SIDED|95.0|1.004|1.451|||||GMC ratio (Cecolin containing arm (Group 5)/Gardasil (Group 4)) and corresponding confidence limits were calculated using linear models of the log concentration values adjusted by site and transformed back to the original scale.|||1.451|1.004|
72561625|NCT02725411|144653880|OTHER|No formal hypotheses were tested in the study.|Difference in Percentage of Participants|1.1|||||TWO_SIDED|95.0|-4.3|6.5||||||Week 16: \>=90%||6.5|-4.3|
72561626|NCT02725411|144653880|OTHER|No formal hypotheses were tested in the study.|Difference in Percentage of Participants|2.1|||||TWO_SIDED|95.0|-3.7|7.8||||||Week 16: \>=90%||7.8|-3.7|
72561627|NCT02725411|144653880|OTHER|No formal hypotheses were tested in the study.|Difference in Percentage of Participants|12.0|||||TWO_SIDED|95.0|-2.3|25.7||||||Week 24: \>=30%||25.7|-2.3|
72561628|NCT02725411|144653880|OTHER|No formal hypotheses were tested in the study.|Difference in Percentage of Participants|-1.6|||||TWO_SIDED|95.0|-15.9|12.6||||||Week 24: \>=30%||12.6|-15.9|
72561629|NCT02725411|144653880|OTHER|No formal hypotheses were tested in the study.|Difference in Percentage of Participants|12.0|||||TWO_SIDED|95.0|-2.4|25.8||||||Week 24: \>=50%||25.8|-2.4|
72561630|NCT02725411|144653880|OTHER|No formal hypotheses were tested in the study.|Difference in Percentage of Participants|5.0|||||TWO_SIDED|95.0|-9.1|18.9||||||Week 24: \>=50%||18.9|-9.1|
72561631|NCT02725411|144653880|OTHER|No formal hypotheses were tested in the study.|Difference in Percentage of Participants|14.1|||||TWO_SIDED|95.0|2.9|24.8||||||Week 24: \>=70%||24.8|2.9|
72561632|NCT02725411|144653880|OTHER|No formal hypotheses were tested in the study.|Difference in Percentage of Participants|10.6|||||TWO_SIDED|95.0|-0.2|21.0||||||Week 24: \>=70%||21.0|-0.2|
72561633|NCT02725411|144653880|OTHER|No formal hypotheses were tested in the study.|Difference in Percentage of Participants|5.4|||||TWO_SIDED|95.0|-0.7|11.4||||||Week 24: \>=90%||11.4|-0.7|
72561634|NCT02725411|144653880|OTHER|No formal hypotheses were tested in the study.|Difference in Percentage of Participants|3.2|||||TWO_SIDED|95.0|-2.2|8.5||||||Week 24: \>=90%||8.5|-2.2|
72561635|NCT02725411|144653880|OTHER|No formal hypotheses were tested in the study.|Difference in Percentage of Participants|17.4|||||TWO_SIDED|95.0|3.1|30.9||||||Week 40: \>=30%||30.9|3.1|
72561636|NCT02725411|144653880|OTHER|No formal hypotheses were tested in the study.|Difference in Percentage of Participants|-0.5|||||TWO_SIDED|95.0|-14.8|13.7||||||Week 40: \>=30%||13.7|-14.8|
72561637|NCT02725411|144653880|OTHER|No formal hypotheses were tested in the study.|Difference in Percentage of Participants|17.4|||||TWO_SIDED|95.0|3.0|31.0||||||Week 40: \>=50%||31.0|3.0|
72561638|NCT02725411|144653880|OTHER|No formal hypotheses were tested in the study.|Difference in Percentage of Participants|5.0|||||TWO_SIDED|95.0|-9.0|18.7||||||Week 40: \>=50%||18.7|-9.0|
72561639|NCT02725411|144653880|OTHER|No formal hypotheses were tested in the study.|Difference in Percentage of Participants|17.4|||||TWO_SIDED|95.0|4.6|29.4||||||Week 40: \>=70%||29.4|4.6|
72561640|NCT02725411|144653880|OTHER|No formal hypotheses were tested in the study.|Difference in Percentage of Participants|7.3|||||TWO_SIDED|95.0|-4.5|18.9||||||Week 40: \>=70%||18.9|-4.5|
72448767|NCT04508309|144415418|NON_INFERIORITY|Non-inferiority of Cecolin at Months 0 and 6 (Group 1) compared to Gardasil at Months 0 and 6 (Group 4) was to be demonstrated if the lower limit of the 95% CI of the GMC ratio was greater than the non-inferiority margin of 0.5 for both HPV-16 and HPV-18.|GMC Ratio|1.12|||||TWO_SIDED|95.0|0.933|1.344|||||GMC ratio (Cecolin/Gardasil) and corresponding confidence limits were calculated using linear models of the log concentration values adjusted by site and transformed back to the original scale.|||1.344|0.933|
72448768|NCT04508309|144415419|NON_INFERIORITY|Non-inferiority of Cecolin at Months 0 and 6 (Group 1) compared to Gardasil at Months 0 and 6 (Group 4) was to be demonstrated if the lower limit of the 95% CI of the GMC ratio was greater than the non-inferiority margin of 0.5 for both HPV-16 and HPV-18.|GMC Ratio|1.32|||||TWO_SIDED|95.0|1.07|1.635|||||GMC ratios (Cecolin/Gardasil) and corresponding confidence limits were calculated using linear models of the log concentration values adjusted by site and transformed back to the original scale.|||1.635|1.070|
72448769|NCT05196919|144415449|SUPERIORITY||Mean Difference (Final Values)|4.2|STANDARD_ERROR_OF_MEAN|8.693||1|TWO_SIDED|95.0|-22.57|30.97|||Mixed Models Analysis|||This was a phase 2a safety study that was not statistically powered for efficacy assessments.||30.97|-22.57|1.00
72498623|NCT03371355|144527601|SUPERIORITY||Least Squares Mean Difference|-1.53||||0.3679|TWO_SIDED|95.0|-4.88|1.83|||ANCOVA|||||1.83|-4.88|0.3679
72498624|NCT03371355|144527601|SUPERIORITY||Least Squares Mean Difference|-4.18||||0.021|TWO_SIDED|95.0|-7.72|-0.65|||ANCOVA|||||-0.65|-7.72|0.0210
72498625|NCT03371355|144527602|SUPERIORITY||Least Squares Mean Difference|-0.15||||0.6227|TWO_SIDED|95.0|-0.73|0.44|||ANCOVA|||||0.44|-0.73|0.6227
72498626|NCT03371355|144527602|SUPERIORITY||Least Squares Mean Difference|-0.38||||0.195|TWO_SIDED|95.0|-0.97|0.2|||ANCOVA|||||0.20|-0.97|0.1950
72498627|NCT03371355|144527602|SUPERIORITY||Least Squares Mean Difference|-0.38||||0.2271|TWO_SIDED|95.0|-1.0|0.24|||ANCOVA|||||0.24|-1.00|0.2271
72498628|NCT03371355|144527603|SUPERIORITY||Least Squares Mean Difference|17.06||||0.8591|TWO_SIDED|95.0|-173.57|207.69|||ANCOVA|||SAT||207.69|-173.57|0.8591
72561641|NCT02725411|144653880|OTHER|No formal hypotheses were tested in the study.|Difference in Percentage of Participants|7.6|||||TWO_SIDED|95.0|1.4|13.5||||||Week 40: \>=90%||13.5|1.4|
72498629|NCT03371355|144527603|SUPERIORITY||Least Squares Mean Difference|32.92||||0.7404|TWO_SIDED|95.0|-164.11|229.95|||ANCOVA|||SAT||229.95|-164.11|0.7404
72448770|NCT05196919|144415449|SUPERIORITY||Mean Difference (Final Values)|7.96|STANDARD_ERROR_OF_MEAN|8.142||0.99|TWO_SIDED|95.0|-17.12|33.03|||Mixed Models Analysis|||This was a phase 2a safety study that was not statistically powered for efficacy assessments.||33.03|-17.12|0.99
72448771|NCT05196919|144415450|SUPERIORITY||Mean Difference (Final Values)|-6.15|STANDARD_ERROR_OF_MEAN|4.676||0.1933|TWO_SIDED|95.0|-15.49|3.19|||Mixed Models Analysis|||This was a phase 2a safety study that was not statistically powered for efficacy assessments.||3.19|-15.49|0.1933
72448772|NCT05196919|144415450|SUPERIORITY||Mean Difference (Final Values)|5.14|STANDARD_ERROR_OF_MEAN|4.434||0.2511|TWO_SIDED|95.0|-3.73|14.0|||Mixed Models Analysis|||This was a phase 2a safety study that was not statistically powered for efficacy assessments.||14.00|-3.73|0.2511
72448773|NCT03621371|144415501|OTHER||F-test|9.88|||<|0.05|TWO_SIDED||||||Mixed Models Analysis|||||||<0.05
72448774|NCT01658930|144415529|NON_INFERIORITY|Margin of inferiority in the difference of 3 year pelvic recurrence rates between simple and radical hysterectomy group was 4%.|Mean Difference (Final Values)|0.0035|||||TWO_SIDED|90.0|-0.0162|0.0232|||||Difference between simple and radical hysterectomy groups.|||0.0232|-0.0162|
72448775|NCT01658930|144415530|SUPERIORITY||Hazard Ratio (HR)|1.12|||||TWO_SIDED|95.0|0.47|2.67|||||Hazard ratio of simple to radical hysterectomy.|||2.67|0.47|
72498630|NCT03371355|144527603|SUPERIORITY||Least Squares Mean Difference|-16.3||||0.8711|TWO_SIDED|95.0|-215.5|182.9|||ANCOVA|||SAT||182.90|-215.50|0.8711
72498631|NCT03371355|144527603|SUPERIORITY||Least Squares Mean Difference|4.95||||0.9569|TWO_SIDED|95.0|-176.64|186.53|||ANCOVA|||VAT||186.53|-176.64|0.9569
72498632|NCT03371355|144527603|SUPERIORITY||Least Squares Mean Difference|-24.26||||0.8025|TWO_SIDED|95.0|-216.53|168.02|||ANCOVA|||VAT||168.02|-216.53|0.8025
72498633|NCT03371355|144527603|SUPERIORITY||Least Squares Mean Difference|22.02||||0.8202|TWO_SIDED|95.0|-170.09|214.12|||ANCOVA|||VAT||214.12|-170.09|0.8202
72498634|NCT03371355|144527604|SUPERIORITY||Least Squares Mean Difference|0.11||||0.9734|TWO_SIDED|95.0|-6.47|6.69|||ANCOVA|||||6.69|-6.47|0.9734
72498635|NCT03371355|144527604|SUPERIORITY||Least Squares Mean Difference|-0.7||||0.8333|TWO_SIDED|95.0|-7.25|5.86|||ANCOVA|||||5.86|-7.25|0.8333
72498636|NCT03371355|144527604|SUPERIORITY||Least Squares Mean Difference|1.66||||0.6207|TWO_SIDED|95.0|-4.99|8.31|||ANCOVA|||||8.31|-4.99|0.6207
72498637|NCT03371355|144527605|SUPERIORITY||Least Squares Mean Difference|0.01||||0.8026|TWO_SIDED|95.0|-0.04|0.06|||ANCOVA|||||0.06|-0.04|0.8026
72498638|NCT03371355|144527605|SUPERIORITY||Least Squares Mean Difference|-0.02||||0.4917|TWO_SIDED|95.0|-0.07|0.03|||ANCOVA|||||0.03|-0.07|0.4917
72498639|NCT03371355|144527605|SUPERIORITY||Least Squares Mean Difference|0.0||||0.8916|TWO_SIDED|95.0|-0.05|0.05|||ANCOVA|||||0.05|-0.05|0.8916
72498640|NCT03371355|144527606|SUPERIORITY||Least Squares Mean Difference|0.11||||0.728|TWO_SIDED|95.0|-0.5|0.71|||ANCOVA|||||0.71|-0.50|0.7280
72498641|NCT03371355|144527606|SUPERIORITY||Least Squares Mean Difference|-0.1||||0.7354|TWO_SIDED|95.0|-0.69|0.49|||ANCOVA|||||0.49|-0.69|0.7354
72561642|NCT02725411|144653880|OTHER|No formal hypotheses were tested in the study.|Difference in Percentage of Participants|5.4|||||TWO_SIDED|95.0|-0.1|10.6||||||Week 40: \>=90%||10.6|-0.1|
72561643|NCT02725411|144653880|OTHER|No formal hypotheses were tested in the study.|Difference in Percentage of Participants|12.0|||||TWO_SIDED|95.0|-2.4|25.8||||||Week 56: \>=30%||25.8|-2.4|
72561644|NCT02725411|144653880|OTHER|No formal hypotheses were tested in the study.|Difference in Percentage of Participants|-3.8|||||TWO_SIDED|95.0|-17.9|10.5||||||Week 56: \>=30%||10.5|-17.9|
72561645|NCT02725411|144653880|OTHER|No formal hypotheses were tested in the study.|Difference in Percentage of Participants|12.0|||||TWO_SIDED|95.0|-2.5|25.9||||||Week 56: \>=50%||25.9|-2.5|
72561646|NCT02725411|144653880|OTHER|No formal hypotheses were tested in the study.|Difference in Percentage of Participants|-2.6|||||TWO_SIDED|95.0|-16.5|11.4||||||Week 56: \>=50%||11.4|-16.5|
72561647|NCT02725411|144653880|OTHER|No formal hypotheses were tested in the study.|Difference in Percentage of Participants|18.5|||||TWO_SIDED|95.0|5.6|30.5||||||Week 56: \>=70%||30.5|5.6|
72561648|NCT02725411|144653880|OTHER|No formal hypotheses were tested in the study.|Difference in Percentage of Participants|8.4|||||TWO_SIDED|95.0|-3.6|20.0||||||Week 56: \>=70%||20.0|-3.6|
72448776|NCT01658930|144415531|SUPERIORITY||Hazard Ratio (HR)|3.82|||||TWO_SIDED|95.0|0.79|18.4|||||Hazard ratio is simple hysterectomy group of radical hysterectomy group.|||18.4|0.79|
72448777|NCT01658930|144415532|SUPERIORITY||Hazard Ratio (HR)|1.54|||||TWO_SIDED|95.0|0.69|3.45|||||Hazard ratio is simple hysterectomy group to radical hysterectomy group.|||3.45|0.69|
72448778|NCT01658930|144415533|SUPERIORITY||Hazard Ratio (HR)|1.09|||||TWO_SIDED|95.0|0.38|3.14|||||Hazard ratio of simple to radical hysterectomy.|||3.14|0.38|
72448779|NCT04909801|144415589|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|1.0||||0.9026|TWO_SIDED|95.0|0.6|1.6|||Regression, Logistic|||||1.6|0.6|0.9026
72448780|NCT04909801|144415590|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|0.9||||0.5824|TWO_SIDED|95.0|0.5|1.5|||Regression, Logistic|||||1.5|0.5|0.5824
72448781|NCT04909801|144415591|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|0.8||||0.3534||95.0|0.5|1.3|||Regression, Logistic|||||1.3|0.5|0.3534
72448782|NCT04909801|144415592|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|0.9||||0.614|TWO_SIDED|95.0|0.5|1.5|||Regression, Logistic|||||1.5|0.5|0.6140
72448783|NCT04909801|144415594|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|0.8||||0.4996|TWO_SIDED|95.0|0.5|1.4|||Regression, Logistic|||Day 29||1.4|0.5|0.4996
72498642|NCT03371355|144527606|SUPERIORITY||Least Squares Mean Difference|-0.23||||0.4682|TWO_SIDED|95.0|-0.84|0.39|||ANCOVA|||||0.39|-0.84|0.4682
72561649|NCT02725411|144653880|OTHER|No formal hypotheses were tested in the study.|Difference in Percentage of Participants|8.7|||||TWO_SIDED|95.0|1.6|15.4||||||Week 56: \>=90%||15.4|1.6|
72448784|NCT04909801|144415594|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|0.8||||0.449|TWO_SIDED|95.0|0.5|1.4|||Regression, Logistic|||Day 57||1.4|0.5|0.4490
72448785|NCT04909801|144415594|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|0.9||||0.809|TWO_SIDED|95.0|0.5|1.7|||Regression, Logistic|||Day 85||1.7|0.5|0.8090
72448786|NCT04909801|144415594|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|1.9||||0.0739|TWO_SIDED|95.0|0.9|3.6|||Regression, Logistic|||Day 113||3.6|0.9|0.0739
72448787|NCT04909801|144415594|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|1.3||||0.4201|TWO_SIDED|95.0|0.7|2.6|||Regression, Logistic|||Day 141||2.6|0.7|0.4201
72448788|NCT04909801|144415594|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|1.1||||0.7928|TWO_SIDED|95.0|0.6|2.0|||Regression, Logistic|||Day 169||2.0|0.6|0.7928
72448789|NCT04909801|144415595|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|0.7||||0.2701|TWO_SIDED|95.0|0.4|1.3|||Regression, Logistic|||Day 29||1.3|0.4|0.2701
72448790|NCT04909801|144415595|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|0.8||||0.4863|TWO_SIDED|95.0|0.5|1.4|||Regression, Logistic|||Day 57||1.4|0.5|0.4863
72448791|NCT04909801|144415595|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|1.0||||0.9513|TWO_SIDED|95.0|0.6|1.7|||Regression, Logistic|||Day 85||1.7|0.6|0.9513
72448792|NCT04909801|144415595|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|1.1||||0.8536|TWO_SIDED|95.0|0.6|1.8|||Regression, Logistic|||Day 113||1.8|0.6|0.8536
72448793|NCT04909801|144415595|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|1.0||||0.9223|TWO_SIDED|95.0|0.6|1.7|||Regression, Logistic|||Day 141||1.7|0.6|0.9223
72448794|NCT04909801|144415595|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|1.0||||0.9026|TWO_SIDED|95.0|0.6|1.6|||Regression, Logistic|||Day 169||1.6|0.6|0.9026
72448795|NCT04909801|144415596|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|0.6||||0.3411|TWO_SIDED|95.0|0.2|1.6|||Regression, Logistic|||Day 29||1.6|0.2|0.3411
72448796|NCT04909801|144415596|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|0.7||||0.2546|TWO_SIDED|95.0|0.4|1.3|||Regression, Logistic|||Day 57||1.3|0.4|0.2546
72448797|NCT04909801|144415596|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|0.8||||0.4558|TWO_SIDED|95.0|0.5|1.4|||Regression, Logistic|||Day 85||1.4|0.5|0.4558
72448798|NCT04909801|144415596|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|1.0||||0.9544|TWO_SIDED|95.0|0.6|1.7|||Regression, Logistic|||Day 113||1.7|0.6|0.9544
72448799|NCT04909801|144415596|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|0.9||||0.545|TWO_SIDED|95.0|0.5|1.4|||Regression, Logistic|||Day 141||1.4|0.5|0.5450
72448800|NCT04909801|144415596|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|0.7||||0.2227|TWO_SIDED|95.0|0.4|1.2|||Regression, Logistic|||Day 169||1.2|0.4|0.2227
72448801|NCT04909801|144415597|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|0.7||||0.32|TWO_SIDED|95.0|0.3|1.4|||Regression, Logistic|||Day 29||1.4|0.3|0.3200
72448802|NCT04909801|144415597|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|0.8||||0.4992|TWO_SIDED|95.0|0.5|1.5|||Regression, Logistic|||Day 57||1.5|0.5|0.4992
72448803|NCT04909801|144415597|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|1.0||||0.8963|TWO_SIDED|95.0|0.6|1.7|||Regression, Logistic|||Day 85||1.7|0.6|0.8963
72448804|NCT04909801|144415597|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|0.8||||0.4544|TWO_SIDED|95.0|0.5|1.4|||Regression, Logistic|||Day 113||1.4|0.5|0.4544
72448805|NCT04909801|144415597|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|1.0||||0.8985|TWO_SIDED|95.0|0.6|1.8|||Regression, Logistic|||Day 141||1.8|0.6|0.8985
72448806|NCT04909801|144415597|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|0.9||||0.5824|TWO_SIDED|95.0|0.5|1.5|||Regression, Logistic|||Day 169||1.5|0.5|0.5824
72448807|NCT04909801|144415598|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|1.5||||0.4152|TWO_SIDED|95.0|0.6|4.1|||Regression, Logistic|||Day 29||4.1|0.6|0.4152
72498643|NCT01957137|144527646|SUPERIORITY_OR_OTHER|||||||0.3773|||||||Mixed Models Analysis|The final model included cycling, period and the interaction between cycling and period.||||||0.3773
72498644|NCT01957137|144527647|SUPERIORITY_OR_OTHER|||||||0.2396|||||||Mixed Models Analysis|The final model included cycling and period.||||||0.2396
72498645|NCT01957137|144527648|SUPERIORITY_OR_OTHER|||||||0.8874|||||||Mixed Models Analysis|The final model included cycling and period.||||||0.8874
72498646|NCT03529409|144527655|SUPERIORITY||Mean Difference (Net)|-0.287||||0.01|TWO_SIDED|95.0|-0.507|-0.066|||Mixed Models Analysis|||||-.066|-.507|.01
72561650|NCT02725411|144653880|OTHER|No formal hypotheses were tested in the study.|Difference in Percentage of Participants|3.2|||||TWO_SIDED|95.0|-2.2|8.5||||||Week 56: \>=90%||8.5|-2.2|
72561651|NCT02725411|144653896|OTHER|No formal hypotheses were tested in the study.|Difference in proportion|0.0|||||TWO_SIDED|95.0|-4.1|4.1||||||95% CI of proportion is the Agresti-Coull confidence limit.||4.1|-4.1|
72448808|NCT04909801|144415598|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|1.2||||0.5917|TWO_SIDED|95.0|0.6|2.5|||Regression, Logistic|||Day 57||2.5|0.6|0.5917
72448809|NCT04909801|144415598|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|1.4||||0.3348|TWO_SIDED|95.0|0.7|2.6|||Regression, Logistic|||Day 85||2.6|0.7|0.3348
72448810|NCT04909801|144415598|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|0.8||||0.3959|TWO_SIDED|95.0|0.4|1.4|||Regression, Logistic|||Day 113||1.4|0.4|0.3959
72448811|NCT04909801|144415598|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|1.2||||0.6225|TWO_SIDED|95.0|0.7|2.0|||Regression, Logistic|||Day 141||2.0|0.7|0.6225
72498647|NCT03529409|144527656|SUPERIORITY||Mean Difference (Net)|1.95||||0.28|TWO_SIDED|95.0|-1.61|5.5||The overall omnibus test of the time by treatment interaction was p=.55. The estimate below is for post-treatment, comparing TAU to Khanya.|Mixed Models Analysis|||||5.50|-1.61|.28
72498648|NCT03529409|144527657|SUPERIORITY||Mean Difference (Net)|157.0||||0.16|TWO_SIDED|95.0|-67.0|382.0||The overall omnibus test of the time by treatment interaction was p=.38. The estimate below is for post-treatment, comparing TAU to Khanya.|Mixed Models Analysis|||||382|-67|.16
72498649|NCT03529409|144527658|SUPERIORITY||Mean Difference (Net)|0.25||||0.77|TWO_SIDED|95.0|-1.51|2.0||The overall omnibus test of the time by treatment interaction was p=.90. The estimate below is for post-treatment, comparing TAU to Khanya.|Mixed Models Analysis|||||2.00|-1.51|.77
72498650|NCT03529409|144527659|SUPERIORITY||Mean Difference (Net)|0.71||||0.63|TWO_SIDED|95.0|-2.24|3.67||The overall omnibus test of the time by treatment interaction was p=.55. The estimate below is for follow-up, comparing TAU to Khanya.|Mixed Models Analysis|||||3.67|-2.24|.63
72498651|NCT03529409|144527660|SUPERIORITY||Mean Difference (Net)|84.0||||0.44|TWO_SIDED|95.0|-136.0|304.0||The overall omnibus test of the time by treatment interaction was p=.38. The estimate below is for follow-up, comparing TAU to Khanya.|Mixed Models Analysis|||||304|-136|.44
72561652|NCT02725411|144653896|OTHER|No formal hypotheses were tested in the study.|Difference in proportion|3.2|||||TWO_SIDED|95.0|-2.2|8.5||||||95% CI of proportion is the Agresti-Coull confidence limit.||8.5|-2.2|
72448812|NCT04909801|144415598|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|0.9||||0.614|TWO_SIDED|95.0|0.5|1.5|||Regression, Logistic|||Day 169||1.5|0.5|0.6140
72448813|NCT04909801|144415599|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|1.1||||0.8084|TWO_SIDED|95.0|0.4|2.9|||Regression, Logistic|||Day 29||2.9|0.4|0.8084
72448814|NCT04909801|144415599|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|1.1||||0.747|TWO_SIDED|95.0|0.5|2.3|||Regression, Logistic|||Day 57||2.3|0.5|0.7470
72448815|NCT04909801|144415599|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|1.2||||0.5233|TWO_SIDED|95.0|0.7|2.3|||Regression, Logistic|||Day 85||2.3|0.7|0.5233
72448816|NCT04909801|144415599|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|0.9||||0.7295|TWO_SIDED|95.0|0.5|1.6|||Regression, Logistic|||Day 113||1.6|0.5|0.7295
72448817|NCT04909801|144415599|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|1.1||||0.7621|TWO_SIDED|95.0|0.6|1.9|||Regression, Logistic|||Day 141||1.9|0.6|0.7621
72448818|NCT04909801|144415599|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|0.9||||0.6861|TWO_SIDED|95.0|0.5|1.6|||Regression, Logistic|||Day 169||1.6|0.5|0.6861
72448819|NCT04909801|144415600|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|0.8||||0.3117|TWO_SIDED|95.0|0.5|1.2|||Regression, Logistic|||Day 29||1.2|0.5|0.3117
72448820|NCT04909801|144415600|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|0.9||||0.612|TWO_SIDED|95.0|0.6|1.4|||Regression, Logistic|||Day 57||1.4|0.6|0.6120
72448821|NCT04909801|144415600|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|0.8||||0.4339|TWO_SIDED|95.0|0.5|1.3|||Regression, Logistic|||Day 85||1.3|0.5|0.4339
72448822|NCT04909801|144415600|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|1.5||||0.1963|TWO_SIDED|95.0|0.8|2.6|||Regression, Logistic|||Day 113||2.6|0.8|0.1963
72448823|NCT04909801|144415600|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|1.3||||0.3275|TWO_SIDED|95.0|0.8|2.3|||Regression, Logistic|||Day 141||2.3|0.8|0.3275
72448824|NCT04909801|144415600|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|1.0||||0.9113|TWO_SIDED|95.0|0.6|1.7|||Regression, Logistic|||Day 169||1.7|0.6|0.9113
72498652|NCT03529409|144527661|SUPERIORITY||Mean Difference (Net)|-0.16||||0.87|TWO_SIDED|95.0|-1.85|1.58||The overall omnibus test of the time by treatment interaction was p=.90. The estimate below is for follow-up, comparing TAU to Khanya.|Mixed Models Analysis|||||1.58|-1.85|.87
72498653|NCT03529409|144527666|SUPERIORITY||Mean Difference (Net)|-0.47||||0.65|TWO_SIDED|95.0|-2.49|1.55||The overall omnibus test of the time by treatment interaction was p=.89. The estimate below is for follow-up, comparing TAU to Khanya.|Mixed Models Analysis|||||1.55|-2.49|.65
72498654|NCT03529409|144527667|SUPERIORITY||Mean Difference (Net)|3.3||||0.63|TWO_SIDED|95.0|-10.5|17.1||The overall omnibus test of the time by treatment interaction was p=.66. The estimate below is for follow-up, comparing TAU to Khanya.|Mixed Models Analysis|||||17.1|-10.5|.63
72498655|NCT03529409|144527668|SUPERIORITY||Mean Difference (Net)|-0.03||||0.85|TWO_SIDED|95.0|-0.34|0.28||The overall omnibus test of the time by treatment interaction was p=.94. The estimate below is for follow-up, comparing TAU to Khanya.|Mixed Models Analysis|||||.28|-.34|.85
72498656|NCT01795547|144527726|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority of the primary endpoint was considered confirmed if the lower bound of the 2-sided 95% CI at Week 28 was \> -5 or equivalently if the p-value for the 1-sided test of H0: D ≤ -5 against H1: D \> -5 was ≤2.5%, where D was the mean treatment difference (aripiprazole minus paliperidone). Superiority was then tested as pre-specified with the FAS and demonstrated for aripiprazole over paliperidone, since the lower bound of the 95% CI was \>0.|Least Squares Mean Difference|4.666||||0.036|TWO_SIDED|95.0|0.316|9.015|||Mixed Models Analysis|The model uses an unstructured variance/covariance matrix.||Comparison of aripiprazole versus paliperidone was made using estimates from a mixed model for repeated measurements (MMRM) using an unstructured covariance matrix.||9.015|0.316|0.036
72561653|NCT02911935|144653929|SUPERIORITY||Hazard Ratio (HR)|1.49||||0.08|TWO_SIDED|95.0|0.95|2.34||unadjusted P-value. The threshold for statistical significance was p = 0.05|Log Rank|||The primary analysis tested the statistical null hypothesis of equal recurrent wheeze rates between the azithromycin and placebo groups.||2.34|0.95|0.08
72448825|NCT04909801|144415601|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|0.7||||0.1247|TWO_SIDED|95.0|0.4|1.1|||Regression, Logistic|||Day 29||1.1|0.4|0.1247
72448826|NCT04909801|144415601|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|0.9||||0.5656|TWO_SIDED|95.0|0.6|1.4|||Regression, Logistic|||Day 57||1.4|0.6|0.5656
72448827|NCT04909801|144415601|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|1.0||||0.897|TWO_SIDED|95.0|0.6|1.5|||Regression, Logistic|||Day 85||1.5|0.6|0.8970
72448828|NCT04909801|144415601|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|1.0||||0.9175|TWO_SIDED|95.0|0.7|1.6|||Regression, Logistic|||Day 113||1.6|0.7|0.9175
72448829|NCT04909801|144415601|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|1.1||||0.5996|TWO_SIDED|95.0|0.7|1.7|||Regression, Logistic|||Day 141||1.7|0.7|0.5996
72448830|NCT04909801|144415601|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|0.8||||0.3534|TWO_SIDED|95.0|0.5|1.3|||Regression, Logistic|||Day 169||1.3|0.5|0.3534
72448831|NCT04909801|144415602|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|0.6||||0.1641|TWO_SIDED|95.0|0.2|1.3|||Regression, Logistic|||Day 29||1.3|0.2|0.1641
72448832|NCT04909801|144415602|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|0.9||||0.5905|TWO_SIDED|95.0|0.5|1.5|||Regression, Logistic|||Day 57||1.5|0.5|0.5905
72448833|NCT04909801|144415602|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|0.9||||0.7146|TWO_SIDED|95.0|0.6|1.5|||Regression, Logistic|||Day 85||1.5|0.6|0.7146
72448834|NCT04909801|144415602|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|1.1||||0.7416|TWO_SIDED|95.0|0.7|1.7|||Regression, Logistic|||Day 113||1.7|0.7|0.7416
72448835|NCT04909801|144415602|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|1.0||||0.9026|TWO_SIDED|95.0|0.6|1.5|||Regression, Logistic|||Day 141||1.5|0.6|0.9026
72448836|NCT04909801|144415602|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|0.8||||0.2605|TWO_SIDED|95.0|0.5|1.2|||Regression, Logistic|||Day 169||1.2|0.5|0.2605
72448837|NCT04909801|144415603|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|0.6||||0.1078|TWO_SIDED|95.0|0.3|1.1|||Regression, Logistic|||Day 29||1.1|0.3|0.1078
72498657|NCT01795547|144527727|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-1.492||||0.043|TWO_SIDED|95.0|-2.935|-0.049||All secondary endpoints were tested without any hierarchical testing strategy and no adjustment for multiplicity|Mixed Models Analysis|The model uses an unstructured variance/covariance matrix.||||-0.049|-2.935|0.043
72448838|NCT04909801|144415603|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|0.7||||0.1855|TWO_SIDED|95.0|0.4|1.2|||Regression, Logistic|||Day 57||1.2|0.4|0.1855
72448839|NCT04909801|144415603|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|0.9||||0.5223|TWO_SIDED|95.0|0.6|1.4|||Regression, Logistic|||Day 85||1.4|0.6|0.5223
72448840|NCT04909801|144415603|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|0.8||||0.4078|TWO_SIDED|95.0|0.5|1.3|||Regression, Logistic|||Day 113||1.3|0.5|0.4078
72448841|NCT04909801|144415603|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|1.2||||0.5238|TWO_SIDED|95.0|0.7|1.8|||Regression, Logistic|||Day 141||1.8|0.7|0.5238
72448842|NCT04909801|144415603|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|0.9||||0.474|TWO_SIDED|95.0|0.5|1.3|||Regression, Logistic|||Day 169||1.3|0.5|0.4740
72448843|NCT04909801|144415604|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|1.2||||0.6565|TWO_SIDED|95.0|0.5|2.9|||Regression, Logistic|||Day 29||2.9|0.5|0.6565
72448844|NCT04909801|144415604|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|1.1||||0.701|TWO_SIDED|95.0|0.6|2.1|||Regression, Logistic|||Day 57||2.1|0.6|0.7010
72448845|NCT04909801|144415604|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|1.3||||0.3683|TWO_SIDED|95.0|0.8|2.1|||Regression, Logistic|||Day 85||2.1|0.8|0.3683
72498658|NCT01795547|144527728|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.283||||0.004|TWO_SIDED|95.0|-0.477|-0.09||All secondary endpoints were tested without any hierarchical testing strategy and no adjustment for multiplicity|Mixed Models Analysis|The model uses an unstructured variance/covariance matrix.||||-0.090|-0.477|0.004
72448846|NCT04909801|144415604|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|1.1||||0.6372|TWO_SIDED|95.0|0.7|1.8|||Regression, Logistic|||Day 113||1.8|0.7|0.6372
72448847|NCT04909801|144415604|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|1.3||||0.2922|TWO_SIDED|95.0|0.8|2.0|||Regression, Logistic|||Day 141||2.0|0.8|0.2922
72448848|NCT04909801|144415604|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|1.1||||0.8178|TWO_SIDED|95.0|0.7|1.7|||Regression, Logistic|||Day 169||1.7|0.7|0.8178
72448849|NCT04909801|144415605|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|1.0||||0.9599|TWO_SIDED|95.0|0.4|2.2|||Regression, Logistic|||Day 29||2.2|0.4|0.9599
72448850|NCT04909801|144415605|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|0.9||||0.7899|TWO_SIDED|95.0|0.5|1.7|||Regression, Logistic|||Day 57||1.7|0.5|0.7899
72448851|NCT04909801|144415605|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|1.1||||0.6305|TWO_SIDED|95.0|0.7|1.9|||Regression, Logistic|||Day 85||1.9|0.7|0.6305
72448852|NCT04909801|144415605|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|1.3||||0.3491|TWO_SIDED|95.0|0.8|2.0|||Regression, Logistic|||Day 113||2.0|0.8|0.3491
72448853|NCT04909801|144415605|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|1.2||||0.4916|TWO_SIDED|95.0|0.7|1.9|||Regression, Logistic|||Day 141||1.9|0.7|0.4916
72448854|NCT04909801|144415605|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|1.1||||0.5697|TWO_SIDED|95.0|0.7|1.8|||Regression, Logistic|||Day 169||1.8|0.7|0.5697
72448855|NCT04909801|144415606|SUPERIORITY|Abatacept - Adalimumab|Adjusted Mean Difference|0.2||||0.0977|TWO_SIDED|95.0|0.0|0.5|||longitudinal|||Day 29||0.5|-0.0|0.0977
72448856|NCT04909801|144415606|SUPERIORITY|Abatacept - Adalimumab|Adjusted Mean Difference|0.2||||0.2889|TWO_SIDED|95.0|-0.1|0.5|||longitudinal|||Day 57||0.5|-0.1|0.2889
72448857|NCT04909801|144415606|SUPERIORITY|Abatacept - Adalimumab|Adjusted Mean Difference|0.0||||0.7676|TWO_SIDED|95.0|-0.3|0.4|||longitudinal|||Day 85||0.4|-0.3|0.7676
72448858|NCT04909801|144415606|SUPERIORITY|Abatacept - Adalimumab|Adjusted Mean Difference|-0.1||||0.6157|TWO_SIDED|95.0|-0.3|0.2|||longitudinal|||Day 113||0.2|-0.3|0.6157
72498659|NCT01795547|144527729|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.331||||0.149|TWO_SIDED|95.0|-0.12|0.782||All secondary endpoints were tested without any hierarchical testing strategy and no adjustment for multiplicity|Mixed Models Analysis|The model uses an unstructured variance/covariance matrix.||||0.782|-0.120|0.149
72448859|NCT04909801|144415606|SUPERIORITY|Abatacept - Adalimumab|Adjusted Mean Difference|-0.1||||0.3904|TWO_SIDED|95.0|-0.4|0.2|||longitudinal|||Day 141||0.2|-0.4|0.3904
72448860|NCT04909801|144415606|SUPERIORITY|Abatacept - Adalimumab|Adjusted Mean Difference|0.0||||0.8359|TWO_SIDED|95.0|-0.4|0.3|||longitudinal|||Day 169||0.3|-0.4|0.8359
72448861|NCT04909801|144415607|SUPERIORITY|Abatacept - Adalimumab|Adjusted Mean Difference|0.4||||0.7852|TWO_SIDED|95.0|-2.3|3.1|||longitudinal|||Day 29||3.1|-2.3|0.7852
72448862|NCT04909801|144415607|SUPERIORITY|Abatacept - Adalimumab|Adjusted Mean Difference|0.6||||0.6336|TWO_SIDED|95.0|-2.0|3.3|||longitudinal|||Day 57||3.3|-2.0|0.6336
72448863|NCT04909801|144415607|SUPERIORITY|Abatacept - Adalimumab|Adjusted Mean Difference|-0.9||||0.4879|TWO_SIDED|95.0|-3.5|1.7|||longitudinal|||Day 85||1.7|-3.5|0.4879
72448864|NCT04909801|144415607|SUPERIORITY|Abatacept - Adalimumab|Adjusted Mean Difference|-1.2||||0.2812|TWO_SIDED|95.0|-3.5|1.0|||longitudinal|||Day 113||1.0|-3.5|0.2812
72448865|NCT04909801|144415607|SUPERIORITY|Abatacept - Adalimumab|Adjusted Mean Difference|-1.7||||0.1205|TWO_SIDED|95.0|-3.9|0.5|||longitudinal|||Day 141||0.5|-3.9|0.1205
72448866|NCT04909801|144415607|SUPERIORITY|Abatacept - Adalimumab|Adjusted Mean Difference|-1.4||||0.3001|TWO_SIDED|95.0|-4.1|1.3|||longitudinal|||Day 169||1.3|-4.1|0.3001
72448867|NCT04909801|144415608|SUPERIORITY|Abatacept - Adalimumab|Adjusted Mean Difference|1.2||||0.4107|TWO_SIDED|95.0|-1.6|4.0|||longitudinal|||Day 29||4.0|-1.6|0.4107
72448868|NCT04909801|144415608|SUPERIORITY|Abatacept - Adalimumab|Adjusted Mean Difference|0.5||||0.6824|TWO_SIDED|95.0|-2.1|3.2|||longitudinal|||Day 57||3.2|-2.1|0.6824
72448869|NCT04909801|144415608|SUPERIORITY|Abatacept - Adalimumab|Adjusted Mean Difference|-0.7||||0.5793|TWO_SIDED|95.0|-3.4|1.9|||longitudinal|||Day 85||1.9|-3.4|0.5793
72448870|NCT04909801|144415608|SUPERIORITY|Abatacept - Adalimumab|Adjusted Mean Difference|-1.5||||0.2883|TWO_SIDED|95.0|-4.2|1.2|||longitudinal|||Day 113||1.2|-4.2|0.2883
72448871|NCT04909801|144415608|SUPERIORITY|Abatacept - Adalimumab|Adjusted Mean Difference|-1.7||||0.1285|TWO_SIDED|95.0|-3.9|0.5|||longitudinal|||Day 141||0.5|-3.9|0.1285
72561654|NCT02911935|144653929|SUPERIORITY||Hazard Ratio (HR)|1.45||||0.11|TWO_SIDED|95.0|0.92|2.29||p-value is adjusted for race, parental history of asthma, ever exposed to smoke and ever exposed to pets. The threshold for statistical significance was p = 0.05|Regression, Cox|||||2.29|0.92|0.11
72448872|NCT04909801|144415608|SUPERIORITY|Abatacept - Adalimumab|Adjusted Mean Difference|-1.5||||0.2815|TWO_SIDED|95.0|-4.2|1.2|||longitudinal|||Day 169||1.2|-4.2|0.2815
72448873|NCT04909801|144415613|SUPERIORITY|Abatacept - Adalimumab|Adjusted Mean Difference|0.3||||0.0099|TWO_SIDED|95.0|0.1|0.5|||longitudinal|||Day 29||0.5|0.1|0.0099
72448874|NCT04909801|144415613|SUPERIORITY|Abatacept - Adalimumab|Adjusted Mean Difference|0.2||||0.1519|TWO_SIDED|95.0|-0.1|0.4|||longitudinal|||Day 57||0.4|-0.1|0.1519
72448875|NCT04909801|144415613|SUPERIORITY|Abatacept - Adalimumab|Adjusted Mean Difference|0.1||||0.2505|TWO_SIDED|95.0|-0.1|0.4|||longitudinal|||Day 85||0.4|-0.1|0.2505
72448876|NCT04909801|144415613|SUPERIORITY|Abatacept - Adalimumab|Adjusted Mean Difference|-0.1||||0.5248|TWO_SIDED|95.0|-0.3|0.2|||longitudinal|||Day 113||0.2|-0.3|0.5248
72448877|NCT04909801|144415613|SUPERIORITY|Abatacept - Adalimumab|Adjusted Mean Difference|0.0||||0.1778|TWO_SIDED|95.0|-0.3|0.2|||longitudinal|||Day 141||0.2|-0.3|0.1778
72448878|NCT04909801|144415613|SUPERIORITY|Abatacept - Adalimumab|Adjusted Mean Difference|0.0||||0.851|TWO_SIDED|95.0|-0.3|0.2|||longitudinal|||Day 169||0.2|-0.3|0.8510
72448879|NCT04909801|144415614|SUPERIORITY|Abatacept - Adalimumab|Adjusted Mean Difference|1.3||||0.2319|TWO_SIDED|95.0|-0.9|3.5|||longitudinal|||Day 29||3.5|-0.9|0.2319
72448880|NCT04909801|144415614|SUPERIORITY|Abatacept - Adalimumab|Adjusted Mean Difference|0.6||||0.5572|TWO_SIDED|95.0|-1.5|2.7|||longitudinal|||Day 57||2.7|-1.5|0.5572
72448881|NCT04909801|144415614|SUPERIORITY|Abatacept - Adalimumab|Adjusted Mean Difference|0.1||||0.9366|TWO_SIDED|95.0|-2.0|2.1|||longitudinal|||Day 85||2.1|-2.0|0.9366
72448882|NCT04909801|144415614|SUPERIORITY|Abatacept - Adalimumab|Adjusted Mean Difference|-1.2||||0.1508|TWO_SIDED|95.0|-3.5|1.0|||longitudinal|||Day 113||1.0|-3.5|0.1508
72448883|NCT04909801|144415614|SUPERIORITY|Abatacept - Adalimumab|Adjusted Mean Difference|-1.9||||0.0303|TWO_SIDED|95.0|-3.6|-0.2|||longitudinal|||Day 141||-0.2|-3.6|0.0303
72448884|NCT04909801|144415614|SUPERIORITY|Abatacept - Adalimumab|Adjusted Mean Difference|-1.2||||0.2333|TWO_SIDED|95.0|-3.3|0.8|||longitudinal|||Day 169||0.8|-3.3|0.2333
72448885|NCT04909801|144415615|SUPERIORITY|Abatacept - Adalimumab|Adjusted Mean Difference|1.9||||0.0938|TWO_SIDED|95.0|-0.3|4.2|||longitudinal|||Day 29||4.2|-0.3|0.0938
72448886|NCT04909801|144415615|SUPERIORITY|Abatacept - Adalimumab|Adjusted Mean Difference|0.6||||0.6053|TWO_SIDED|95.0|-1.6|2.7|||longitudinal|||Day 57||2.7|-1.6|0.6053
72448887|NCT04909801|144415615|SUPERIORITY|Abatacept - Adalimumab|Adjusted Mean Difference|0.2||||0.857|TWO_SIDED|95.0|-1.9|2.3|||longitudinal|||Day 85||2.3|-1.9|0.8570
72448888|NCT04909801|144415615|SUPERIORITY|Abatacept - Adalimumab|Adjusted Mean Difference|-1.2||||0.1592|TWO_SIDED|95.0|-3.0|0.5|||longitudinal|||Day 113||0.5|-3.0|0.1592
72448889|NCT04909801|144415615|SUPERIORITY|Abatacept - Adalimumab|Adjusted Mean Difference|-1.9||||0.0319|TWO_SIDED|95.0|-3.7|-0.2|||longitudinal|||Day 141||-0.2|-3.7|0.0319
72448890|NCT04909801|144415615|SUPERIORITY|Abatacept - Adalimumab|Adjusted Mean Difference|-1.3||||0.2059|TWO_SIDED|95.0|-3.4|0.7|||longitudinal|||Day 169||0.7|-3.4|0.2059
72448891|NCT05875467|144415624|SUPERIORITY|||||||0.042|||||||t-test, 2 sided|||||||.042
72448892|NCT05875467|144415625|SUPERIORITY|||||||0.928|||||||t-test, 2 sided|||||||.928
72448893|NCT05875467|144415626|SUPERIORITY|||||||0.022|||||||t-test, 2 sided|||||||.022
72448894|NCT05875467|144415627|SUPERIORITY|||||||0.004|||||||t-test, 2 sided|||||||.004
72448895|NCT03257410|144415711|SUPERIORITY||Mean Difference (Final Values)|14.828|||||TWO_SIDED|95.0|10.501|19.156|||||Method=ANCOVA|If the lower bound of the two-sided 95% confidence interval around the difference between Theranova 400 and Elisio-17H is \> 0 then superiority will be demonstrated.||19.156|10.501|
72561655|NCT02911935|144653930|SUPERIORITY||Hazard Ratio (HR)|1.95||||0.12|TWO_SIDED|95.0|0.83|4.61||Unadjusted. The threshold for statistical significance was p = 0.05|Log Rank|||||4.61|0.83|0.12
72561656|NCT02911935|144653931|SUPERIORITY||Rate Ratio|1.18||||0.31|TWO_SIDED|95.0|0.86|1.62||Unadjusted. The threshold for statistical significance was p = 0.05|Negative Binomial Regression Analysis|||||1.62|0.86|0.31
72448896|NCT03257410|144415712|NON_INFERIORITY|If the lower bound of the two-sided 95% confidence interval around the mean estimated treatment difference between Theranova 400 and Elisio 17H is \> -0.1765 g/dL then non-inferiority can be claimed. If the lower bound of the two-sided 95% confidence interval is \> 0, then superiority may be concluded.|Mean Difference (Final Values)|-0.015|||||TWO_SIDED|95.0|-0.098|0.069|||ANCOVA|||||0.069|-0.098|
72448897|NCT03257410|144415713|OTHER||Mean Difference (Final Values)|19.42|STANDARD_ERROR_OF_MEAN|2.103|<|0.0001|TWO_SIDED||||||Mixed-effect Model Repeated Measurement|||Week 4||||<0.0001
72448898|NCT03257410|144415713|OTHER||Mean Difference (Final Values)|16.1|STANDARD_ERROR_OF_MEAN|2.115|<|0.0001|TWO_SIDED||||||Mixed-effect Model Repeated Measurement|||Week 24||||<0.0001
72448899|NCT03257410|144415714|OTHER||Mean Difference (Final Values)|25.07|STANDARD_ERROR_OF_MEAN|4.3|<|0.0001|TWO_SIDED||||||MMRM|||Week 4||||<0.0001
72448900|NCT03257410|144415714|OTHER||Mean Difference (Final Values)|23.54|STANDARD_ERROR_OF_MEAN|2.0|<|0.0001|TWO_SIDED||||||MMRM|||Week 24||||<0.0001
72448901|NCT03257410|144415715|OTHER||Mean Difference (Final Values)|15.89|STANDARD_ERROR_OF_MEAN|2.73|<|0.0001|TWO_SIDED||||||MMRM|||Week 4||||<0.0001
72448902|NCT03257410|144415715|OTHER||Mean Difference (Final Values)|15.36|STANDARD_ERROR_OF_MEAN|2.479|<|0.0001|TWO_SIDED||||||MMRM|||Week 24||||<0.0001
72448903|NCT03257410|144415716|OTHER||Mean Difference (Final Values)|17.59|STANDARD_ERROR_OF_MEAN|9.583||0.0684|TWO_SIDED||||||MMRM|||Week 4||||0.0684
72448904|NCT03257410|144415716|OTHER||Mean Difference (Final Values)|13.98|STANDARD_ERROR_OF_MEAN|7.937||0.0806|TWO_SIDED||||||MMRM|||Week 24||||0.0806
72448905|NCT03257410|144415721|OTHER||Mean Difference (Final Values)|-0.07|STANDARD_ERROR_OF_MEAN|0.033||0.0347|TWO_SIDED||||||Mixed-effect Model Repeated Measurement|||Week 4||||0.0347
72448906|NCT03257410|144415721|OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.033||0.0036|TWO_SIDED||||||Mixed-effect Model Repeated Measurement|||Week 8||||0.0036
72448907|NCT03257410|144415721|OTHER||Mean Difference (Final Values)|-0.06|STANDARD_ERROR_OF_MEAN|0.04||0.129|TWO_SIDED||||||Mixed-effect Model Repeated Measurement|||Week 12||||0.129
72448908|NCT03257410|144415721|OTHER||Mean Difference (Final Values)|-0.08|STANDARD_ERROR_OF_MEAN|0.052||0.1149|TWO_SIDED||||||Mixed-effect Model Repeated Measurement|||Week 16||||0.1149
72448909|NCT03257410|144415721|OTHER||Mean Difference (Final Values)|-0.08|STANDARD_ERROR_OF_MEAN|0.044||0.0688|TWO_SIDED||||||Mixed-effect Model Repeated Measurement|||Week 20||||0.0688
72448910|NCT03257410|144415721|OTHER||Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.042||0.6097|TWO_SIDED||||||Mixed-effect Model Repeated Measurement|||Week 24||||0.6097
72448911|NCT03257410|144415722|OTHER||Mean Difference (Final Values)|-6.32|STANDARD_ERROR_OF_MEAN|4.336||0.1472|TWO_SIDED||||||Mixed-effect Model Repeated Measurement|||Week 12||||0.1472
72448912|NCT03257410|144415722|OTHER||Mean Difference (Final Values)|-11.18|STANDARD_ERROR_OF_MEAN|7.154||0.1207|TWO_SIDED||||||Mixed-effect Model Repeated Measurement|||Week 24||||0.1207
72448913|NCT03257410|144415723|OTHER||Mean Difference (Final Values)|-0.07|STANDARD_ERROR_OF_MEAN|2.488||0.9775|TWO_SIDED||||||Mixed-effect Model Repeated Measurement|||Week 12||||0.9775
72448914|NCT03257410|144415723|OTHER||Mean Difference (Final Values)|1.72|STANDARD_ERROR_OF_MEAN|2.905||0.5538|TWO_SIDED||||||Mixed-effect Model Repeated Measurement|||Week 24||||0.5538
72448915|NCT03257410|144415724|OTHER||Mean Difference (Final Values)|-0.23|STANDARD_ERROR_OF_MEAN|0.146||0.11|TWO_SIDED||||||Mixed-effect Model Repeated Measurement|||Week 4||||0.1100
72448916|NCT03257410|144415724|OTHER||Mean Difference (Final Values)|-0.11|STANDARD_ERROR_OF_MEAN|0.153||0.4607|TWO_SIDED||||||Mixed-effect Model Repeated Measurement|||Week 24||||0.4607
72448917|NCT03257410|144415725|OTHER||Mean Difference (Final Values)|-0.0787|STANDARD_ERROR_OF_MEAN|0.04454||0.0791|TWO_SIDED||||||Mixed-effect Model Repeated Measurement|||Week 4||||0.0791
72448918|NCT03257410|144415725|OTHER||Mean Difference (Final Values)|-0.0027|STANDARD_ERROR_OF_MEAN|0.04302||0.9505|TWO_SIDED||||||Mixed-effect Model Repeated Measurement|||Week 8||||0.9505
72448919|NCT03257410|144415725|OTHER||Mean Difference (Final Values)|-0.0615|STANDARD_ERROR_OF_MEAN|0.04271||0.1521|TWO_SIDED||||||Mixed-effect Model Repeated Measurement|||Week 12||||0.1521
72448920|NCT03257410|144415725|OTHER||Mean Difference (Final Values)|0.0538|STANDARD_ERROR_OF_MEAN|0.04652||0.2489|TWO_SIDED||||||Mixed-effect Model Repeated Measurement|||Week 16||||0.2489
72448921|NCT03257410|144415725|OTHER||Mean Difference (Final Values)|-0.0345|STANDARD_ERROR_OF_MEAN|0.05025||0.4936|TWO_SIDED||||||Mixed-effect Model Repeated Measurement|||Week 20||||0.4936
72448922|NCT03257410|144415725|OTHER||Mean Difference (Final Values)|-0.0663|STANDARD_ERROR_OF_MEAN|0.0458||0.1497|TWO_SIDED||||||Mixed-effect Model Repeated Measurement|||Week 24||||0.1497
72448923|NCT03257410|144415726|OTHER||Mean Difference (Final Values)|-0.25|STANDARD_ERROR_OF_MEAN|2.012||0.9001|TWO_SIDED||||||Mixed-effect Model Repeated Measurement|||Week 12||||0.9001
72448924|NCT03257410|144415726|OTHER||Mean Difference (Final Values)|-2.33|STANDARD_ERROR_OF_MEAN|2.372||0.3279|TWO_SIDED||||||Mixed-effect Model Repeated Measurement|||Week 24||||0.3279
72448925|NCT03257410|144415727|OTHER||Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|0.452||0.6576|TWO_SIDED||||||ANCOVA|||||||0.6576
72448926|NCT03257410|144415728|OTHER||Mean Difference (Final Values)|0.29|STANDARD_ERROR_OF_MEAN|0.104||0.0058|TWO_SIDED||||||ANCOVA|||||||0.0058
72448927|NCT03257410|144415729|OTHER||Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.023||0.034|TWO_SIDED||||||ANCOVA|||||||0.034
72448928|NCT03257410|144415730|OTHER||Mean Difference (Final Values)|0.16|STANDARD_ERROR_OF_MEAN|0.071||0.0285|TWO_SIDED||||||ANCOVA|||||||0.0285
72448929|NCT03257410|144415731|OTHER||Mean Difference (Final Values)|-0.06|STANDARD_ERROR_OF_MEAN|0.513||0.9069|TWO_SIDED||||||ANCOVA|||||||0.9069
72448930|NCT03257410|144415732|OTHER||Mean Difference (Final Values)|0.09|STANDARD_ERROR_OF_MEAN|0.443||0.8413|TWO_SIDED||||||ANCOVA|||||||0.8413
72448931|NCT03257410|144415733|OTHER||Mean Difference (Final Values)|-0.97|STANDARD_ERROR_OF_MEAN|0.382||0.0125|TWO_SIDED||||||ANCOVA|||||||0.0125
72448932|NCT03257410|144415734|OTHER||Mean Difference (Final Values)|0.22|STANDARD_ERROR_OF_MEAN|0.561||0.6891|TWO_SIDED||||||ANCOVA|||||||0.6891
72448933|NCT03257410|144415735|OTHER||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.047||0.6043|TWO_SIDED||||||ANCOVA|||||||0.6043
72448934|NCT03257410|144415736|OTHER||Mean Difference (Final Values)|1.39|STANDARD_ERROR_OF_MEAN|2.08||0.5067|TWO_SIDED||||||ANCOVA|||||||0.5067
72448935|NCT03257410|144415737|OTHER||Mean Difference (Net)|0.02|STANDARD_ERROR_OF_MEAN|0.009||0.0297|TWO_SIDED||||||ANCOVA|||||||0.0297
72448936|NCT03257410|144415738|OTHER||Mean Difference (Final Values)|3.24|STANDARD_ERROR_OF_MEAN|2.14||0.1325|TWO_SIDED||||||ANCOVA|||||||0.1325
72498660|NCT01795547|144527730|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|1.753||||0.039|TWO_SIDED|95.0|0.093|3.412||All secondary endpoints were tested without any hierarchical testing strategy and no adjustment for multiplicity|Mixed Models Analysis|The model uses an unstructured variance/covariance matrix.||||3.412|0.093|0.039
72448937|NCT03257410|144415739|OTHER||Mean Difference (Final Values)|0.22|STANDARD_ERROR_OF_MEAN|0.186||0.2304|TWO_SIDED||||||ANCOVA|||||||0.2304
72448938|NCT03257410|144415740|OTHER||Mean Difference (Final Values)|-1.59|STANDARD_ERROR_OF_MEAN|2.846||0.5785|TWO_SIDED||||||ANCOVA|||||||0.5785
72448939|NCT03257410|144415741|OTHER||Mean Difference (Final Values)|2.55|STANDARD_ERROR_OF_MEAN|0.918||0.0067|TWO_SIDED||||||ANCOVA|||||||0.0067
72448940|NCT03257410|144415742|OTHER||Mean Difference (Final Values)|-14.93|STANDARD_ERROR_OF_MEAN|7.314||0.0434|TWO_SIDED||||||ANCOVA|||||||0.0434
72448941|NCT03257410|144415743|OTHER||Mean Difference (Final Values)|0.07|STANDARD_ERROR_OF_MEAN|0.07||0.3281|TWO_SIDED||||||ANCOVA|||||||0.3281
72448942|NCT03257410|144415744|OTHER||Mean Difference (Final Values)|-0.67|STANDARD_ERROR_OF_MEAN|0.334||0.0463|TWO_SIDED||||||ANCOVA|||||||0.0463
72448943|NCT03257410|144415745|OTHER||Mean Difference (Final Values)|0.08|STANDARD_ERROR_OF_MEAN|0.06||0.1925|TWO_SIDED||||||ANCOVA|||||||0.1925
72619539|NCT00944645|144769949|NON_INFERIORITY_OR_EQUIVALENCE|Primary research hypothesis II: The total urinary excretion of niacin and niacin metabolites following the administration of MK0524 (ER niacin 1000 mg/ laropiprant 20 mg) tablets from 2 manufacturing sites is similar (i.e., the true GMR of total urinary excretion of niacin and its metabolites is contained within the bioequivalence interval (0.80, 1.25)).|Geometric Mean Ratio|0.94||||||90.0|0.89|0.98||||||"MK0524A (1000 mg ER Niacin/20 mg MK-laropiprant) tablet from new manufacturing site (Source 2)~MK0524A (1000 mg ER Niacin/20 mg MK-laropiprant) Phase III tablet (Source 1)"||0.98|0.89|
72448944|NCT03257410|144415746|OTHER||Mean Difference (Final Values)|0.44|STANDARD_ERROR_OF_MEAN|0.389||0.2569|TWO_SIDED||||||ANCOVA|||||||0.2569
72448945|NCT03257410|144415747|OTHER||Mean Difference (Final Values)|0.63|STANDARD_ERROR_OF_MEAN|1.104||0.5709|TWO_SIDED||||||ANCOVA|||||||0.5709
72448946|NCT03257410|144415748|OTHER||Mean Difference (Final Values)|0.51|STANDARD_ERROR_OF_MEAN|0.412||0.217|TWO_SIDED||||||ANCOVA|||||||0.217
72448947|NCT03257410|144415749|OTHER||Mean Difference (Final Values)|-1.53|STANDARD_ERROR_OF_MEAN|1.292||0.2386|TWO_SIDED||||||ANCOVA|||||||0.2386
72448948|NCT03257410|144415750|OTHER||Mean Difference (Final Values)|-1.14|STANDARD_ERROR_OF_MEAN|0.84||0.1769|TWO_SIDED||||||ANCOVA|||||||0.1769
72448949|NCT03257410|144415751|OTHER||Mean Difference (Final Values)|-0.09|STANDARD_ERROR_OF_MEAN|0.36||0.8102|TWO_SIDED||||||ANCOVA|||||||0.8102
72448950|NCT03257410|144415752|OTHER||Mean Difference (Final Values)|-0.06|STANDARD_ERROR_OF_MEAN|1.501||0.9672|TWO_SIDED||||||ANCOVA|||||||0.9672
72448951|NCT03257410|144415753|OTHER||Mean Difference (Final Values)|27.34|STANDARD_ERROR_OF_MEAN|24.623||0.2697|TWO_SIDED||||||ANCOVA|||||||0.2697
72448952|NCT03257410|144415756|OTHER||Mean Difference (Final Values)|0.04|STANDARD_ERROR_OF_MEAN|0.115||0.7189|TWO_SIDED||||||ANCOVA|||||||0.7189
72448953|NCT03257410|144415757|OTHER||Mean Difference (Final Values)|0.07|STANDARD_ERROR_OF_MEAN|0.044||0.097|TWO_SIDED||||||ANCOVA|||||||0.097
72448954|NCT03257410|144415758|OTHER||Mean Difference (Final Values)|0.09|STANDARD_ERROR_OF_MEAN|0.113||0.4513|TWO_SIDED||||||ANCOVA|||||||0.4513
72448955|NCT03257410|144415759|OTHER||Mean Difference (Final Values)|-0.18|STANDARD_ERROR_OF_MEAN|0.1||0.0733|TWO_SIDED||||||ANCOVA|||||||0.0733
72448956|NCT03257410|144415760|OTHER||Mean Difference (Final Values)|-3.42|STANDARD_ERROR_OF_MEAN|5.467||0.5326|TWO_SIDED||||||ANCOVA|||||||0.5326
72448957|NCT03257410|144415761|OTHER||Mean Difference (Final Values)|-1.11|STANDARD_ERROR_OF_MEAN|1.076||0.3042|TWO_SIDED||||||ANCOVA|||||||0.3042
72448958|NCT03257410|144415762|OTHER||Mean Difference (Final Values)|-0.58|STANDARD_ERROR_OF_MEAN|0.976||0.5534|TWO_SIDED||||||ANCOVA|||||||0.5534
72448959|NCT03257410|144415763|OTHER||Mean Difference (Final Values)|1.34|STANDARD_ERROR_OF_MEAN|1.181||0.2958|TWO_SIDED||||||ANCOVA|||||||0.2958
72448960|NCT03257410|144415764|OTHER||Mean Difference (Final Values)|-0.63|STANDARD_ERROR_OF_MEAN|0.377||0.0998|TWO_SIDED||||||ANCOVA|||||||0.0998
72448961|NCT03257410|144415765|OTHER||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|3.176||0.9952|TWO_SIDED||||||ANCOVA|||||||0.9952
72448962|NCT03257410|144415766|OTHER||Mean Difference (Final Values)|-0.71|STANDARD_ERROR_OF_MEAN|0.693||0.3063|TWO_SIDED||||||ANCOVA|||||||0.3063
72448963|NCT03257410|144415767|OTHER||Mean Difference (Final Values)|-0.85|STANDARD_ERROR_OF_MEAN|0.529||0.1098|TWO_SIDED||||||ANCOVA|||||||0.1098
72498661|NCT01795547|144527731|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|1.764||||0.07|TWO_SIDED|95.0|-0.143|3.672||All secondary endpoints were tested without any hierarchical testing strategy and no adjustment for multiplicity|Mixed Models Analysis|The model uses an unstructured variance/covariance matrix.||||3.672|-0.143|0.070
72498662|NCT01795547|144527732|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.922||||0.13|TWO_SIDED|95.0|-0.275|2.119||All secondary endpoints were tested without any hierarchical testing strategy and no adjustment for multiplicity|Mixed Models Analysis|The model uses an unstructured variance/covariance matrix.||||2.119|-0.275|0.130
72498663|NCT01795547|144527733|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|1.007||||0.561|TWO_SIDED|95.0|-2.402|4.417||All secondary endpoints were tested without any hierarchical testing strategy and no adjustment for multiplicity|Mixed Models Analysis|The model uses an unstructured variance/covariance matrix.||||4.417|-2.402|0.561
72448964|NCT03257410|144415768|OTHER||Mean Difference (Final Values)|-1.44|STANDARD_ERROR_OF_MEAN|0.797||0.0766|TWO_SIDED||||||ANCOVA|||||||0.0766
72448965|NCT03257410|144415769|OTHER||Mean Difference (Final Values)|-2.58|STANDARD_ERROR_OF_MEAN|2.41||0.2886|TWO_SIDED||||||ANCOVA|||||||0.2886
72448966|NCT03257410|144415770|OTHER||Mean Difference (Final Values)|-0.03|STANDARD_ERROR_OF_MEAN|0.042||0.4513|TWO_SIDED||||||ANCOVA|||||||0.4513
72448967|NCT03257410|144415771|OTHER||Mean Difference (Final Values)|1.56|STANDARD_ERROR_OF_MEAN|2.96||0.5992|TWO_SIDED||||||ANCOVA|||||||0.5992
72448968|NCT03257410|144415772|OTHER||Mean Difference (Final Values)|-0.26|STANDARD_ERROR_OF_MEAN|0.29||0.3836|TWO_SIDED||||||ANCOVA|||||||0.3836
72448969|NCT03257410|144415773|OTHER||Mean Difference (Final Values)|-13.07|STANDARD_ERROR_OF_MEAN|7.284||0.0769|TWO_SIDED||||||ANCOVA|||||||0.0769
72448970|NCT03257410|144415774|OTHER||Mean Difference (Final Values)|-19.56|STANDARD_ERROR_OF_MEAN|5.17||0.0002|TWO_SIDED||||||ANCOVA|||||||0.0002
72448971|NCT03257410|144415775|OTHER||Mean Difference (Final Values)|-1.39|STANDARD_ERROR_OF_MEAN|1.039||0.1825|TWO_SIDED||||||ANCOVA|||||||0.1825
72448972|NCT03257410|144415776|OTHER||Mean Difference (Final Values)|-1.24|STANDARD_ERROR_OF_MEAN|0.737||0.0957|TWO_SIDED||||||ANCOVA|||||||0.0957
72561657|NCT02911935|144653932|SUPERIORITY||Rate Ratio|1.22||||0.57|TWO_SIDED|95.0|0.6|2.48||Unadjusted. The threshold for statistical significance was p = 0.05|Negative Binomial Regression Analysis|||||2.48|0.6|0.57
72561658|NCT02911935|144653933|SUPERIORITY||Rate Ratio|1.34||||0.38|TWO_SIDED|95.0|0.7|2.57||unadjusted P-value. The threshold for statistical significance was p = 0.05|Negative Binomial Regression Analysis|||||2.57|0.70|0.38
72619540|NCT00944645|144769950|NON_INFERIORITY_OR_EQUIVALENCE|Primary research hypothesis III: The AUC0-infinity of laropiprant following the administration of MK0524A (ER niacin 1000 mg/ laropiprant 20 mg) tablets from 2 manufacturing sites is similar (i.e., the true GMR of MK0524 AUC0-∞ is contained within the bioequivalence interval (0.80, 1.25)).|Geometric Mean Ratio|1.0||||||95.0|0.95|1.05||||||"Group B: MK0524A (1000 mg ER Niacin/20 mg MK-laropiprant) tablet from new manufacturing site (Source 2)~Group A: MK0524A (1000 mg ER Niacin/20 mg MK-laropiprant) Phase III tablet (Source 1)"||1.05|0.95|
72448973|NCT03257410|144415777|OTHER||Mean Difference (Final Values)|-34.02|STANDARD_ERROR_OF_MEAN|10.23||0.0012|TWO_SIDED||||||ANCOVA|||||||0.0012
72448974|NCT03257410|144415778|OTHER||Mean Difference (Final Values)|-1.17|STANDARD_ERROR_OF_MEAN|0.859||0.1824|TWO_SIDED||||||ANCOVA|||||||0.1824
72448975|NCT02561247|144415779|OTHER|||||||0.0008||||||P Value is from a one sample t-test compared against the null hypothesis value|t-test, 1 sided|Null Hypothesis Value = -38; Degrees of Freedom=16; t-value=-4.13||P Value is from a one sample t-test compared against the null hypothesis value. No adjustments were made for multiple comparisons/multiplicity in this study, since there was only one primary endpoint, one arm, and one pre-specified primary null hypothesis.||||0.0008
72448976|NCT03656510|144415817|OTHER||Mean Difference (Final Values)|-0.6|||||TWO_SIDED|95.0|-1.382|0.185||||||Difference versus placebo in mean RSV viral load AUC on Day 3||0.185|-1.382|
72561659|NCT02911935|144653934|SUPERIORITY||Rate Ratio|0.92||||0.56|TWO_SIDED|95.0|0.7|1.22||Unadjusted. The threshold for statistical significance was p = 0.05|Negative Binomial Regression Analysis|||||1.22|0.7|0.56
72619541|NCT00944645|144769951|NON_INFERIORITY_OR_EQUIVALENCE|Primary research hypothesis IV: The Cmax of laropiprant following the administration of MK0524A (ER niacin 1000 mg/ laropiprant 20 mg) tablets from 2 manufacturing sites is similar (i.e., the true GMR of MK0524 Cmax is contained within the bioequivalence interval (0.80, 1.25)).|Geometric Mean Ratio|1.02||||||95.0|0.96|1.09||||||"MK0524A (1000 mg ER Niacin/20 mg MK-laropiprant) tablet from new manufacturing site (Source 2)~MK0524A (1000 mg ER Niacin/20 mg MK-laropiprant) Phase III tablet (Source 1)"||1.09|0.96|
72448977|NCT03656510|144415817|OTHER||Mean Difference (Final Values)|-0.39|||||TWO_SIDED|95.0|-1.19|0.418||||||Difference versus placebo in mean RSV viral load AUC on Day 3||0.418|-1.190|
72448978|NCT03656510|144415817|OTHER||Mean Difference (Final Values)|-2.46|||||TWO_SIDED|95.0|-4.674|-0.25||||||Difference versus placebo in mean RSV viral load AUC on Day 8||-0.250|-4.674|
72448979|NCT03656510|144415817|OTHER||Mean Difference (Final Values)|-2.38|||||TWO_SIDED|95.0|-4.645|-0.114||||||Difference versus placebo in mean RSV viral load AUC on Day 8||-0.114|-4.645|
72448980|NCT05671653|144415863|OTHER|Analysis done using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Ratio (Test/Reference) and 90% confidence interval (CI) are expressed as percentages.|Ratio (%) of Adjusted Geometric Means|88.85|||||TWO_SIDED|90.0|80.25|98.38||||||Reference: Cohort 1: Midazolam 2 mg + Omeprazole 20 mg (Period 1). Test: Cohort 1: PF-07081532 80 mg QD + Midazolam 2 mg + Omeprazole 20 mg (Period 4).||98.38|80.25|
72448981|NCT05671653|144415863|OTHER|Analysis done using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Ratio (Test/Reference) and 90% confidence interval (CI) are expressed as percentages.|Ratio (%) of Adjusted Geometric Means|70.0|||||TWO_SIDED|90.0|55.21|88.76||||||Reference: Cohort 1: Midazolam 2 mg + Omeprazole 20 mg (Period 1). Test: Cohort 1: PF-07081532 260 mg QD + Midazolam 2 mg + Omeprazole 20 mg (Period 7).||88.76|55.21|
72448982|NCT05671653|144415864|OTHER|Analysis done using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Ratio (Test/Reference) and 90% confidence interval (CI) are expressed as percentages.|Ratio (%) of Adjusted Geometric Means|57.19|||||TWO_SIDED|90.0|39.27|83.29||||||Reference: Cohort 1: Midazolam 2 mg + Omeprazole 20 mg (Period 1). Test: Cohort 1: PF-07081532 80 mg QD + Midazolam 2 mg + Omeprazole 20 mg (Period 4).||83.29|39.27|
72448983|NCT05671653|144415864|OTHER|Analysis done using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Ratio (Test/Reference) and 90% confidence interval (CI) are expressed as percentages.|Ratio (%) of Adjusted Geometric Means|29.68|||||TWO_SIDED|90.0|19.6|44.94||||||Reference: Cohort 1: Midazolam 2 mg + Omeprazole 20 mg (Period 1). Test: Cohort 1: PF-07081532 260 mg QD + Midazolam 2 mg + Omeprazole 20 mg (Period 7).||44.94|19.60|
72448984|NCT05671653|144415865|OTHER|Analysis done using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Ratio (Test/Reference) and 90% confidence interval (CI) are expressed as percentages.|Ratio (%) of Adjusted Geometric Means|119.86|||||TWO_SIDED|90.0|108.97|131.85||||||Reference: Cohort 1: LE 0.15 mg \& EE 0.03 mg (Period 2). Test: Cohort 1: PF-07081532 80 mg QD + LE 0.15 mg \& EE 0.03 mg (Period 5).||131.85|108.97|
72448985|NCT05671653|144415865|OTHER|Analysis done using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Ratio (Test/Reference) and 90% confidence interval (CI) are expressed as percentages.|Ratio (%) of Adjusted Geometric Means|185.45|||||TWO_SIDED|90.0|108.0|318.44||||||Reference: Cohort 1: LE 0.15 mg \& EE 0.03 mg (Period 2). Test: Cohort 1: PF-07081532 260 mg QD + LE 0.15 mg \& EE 0.03 mg (Period 8)||318.44|108.00|
72561660|NCT01160640|144653996|SUPERIORITY_OR_OTHER|||||||0.046||||||P-value for proportion of women who had clearance of anaerobic organisms from the endometrium at the 30-day visit|Fisher Exact|||||||0.046
72561661|NCT01160640|144653998|SUPERIORITY_OR_OTHER|||||||0.16||||||P-value for proportion of women who did not have M. genitalium detected in the cervix or endometrium at the 30-day visit|Fisher Exact|||||||0.16
72561662|NCT01160640|144653999|SUPERIORITY_OR_OTHER|||||||0.74||||||P-value for proportion of women who experienced resolution of clinical signs and symptoms of PID at the 3-day visit|Fisher Exact|||||||0.74
72448986|NCT05671653|144415866|OTHER|Analysis done using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Ratio (Test/Reference) and 90% confidence interval (CI) are expressed as percentages.|Ratio (%) of Adjusted Geometric Means|103.17|||||TWO_SIDED|90.0|95.09|111.93||||||Reference: Cohort 1: LE 0.15 mg \& EE 0.03 mg (Period 2). Test: Cohort 1: PF-07081532 80 mg QD + LE 0.15 mg \& EE 0.03 mg (Period 5).||111.93|95.09|
72448987|NCT05671653|144415866|OTHER|Analysis done using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Ratio (Test/Reference) and 90% confidence interval (CI) are expressed as percentages.|Ratio (%) of Adjusted Geometric Means|90.2|||||TWO_SIDED|90.0|60.24|135.06||||||Reference: Cohort 1: LE 0.15 mg \& EE 0.03 mg (Period 2). Test: Cohort 1: PF-07081532 260 mg QD + LE 0.15 mg \& EE 0.03 mg (Period 8)||135.06|60.24|
72448988|NCT05671653|144415867|OTHER|Analysis done using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Ratio (Test/Reference) and 90% confidence interval (CI) are expressed as percentages.|Ratio (%) of Adjusted Geometric Means|92.88|||||TWO_SIDED|90.0|79.97|107.87||||||Reference: Cohort 2: Midazolam 2 mg (Period 1). Test: Cohort 2: Semaglutide 2.4 mg QW + Midazolam 2 mg (Period 3).||107.87|79.97|
72448989|NCT05274074|144416035|SUPERIORITY||Mean Difference (Net)|1.4||||0.57|TWO_SIDED|95.0|-3.4|6.2|||Regression, Linear|||||6.2|-3.4|0.57
72448990|NCT05274074|144416036|SUPERIORITY||Mean Difference (Net)|-0.1||||0.53|TWO_SIDED|95.0|-0.5|0.2|||Regression, Linear|||||0.2|-0.5|0.53
72448991|NCT05274074|144416037|SUPERIORITY||Mean Difference (Net)|-1.0||||0.41|TWO_SIDED|95.0|-3.3|1.4|||Regression, Linear|||||1.4|-3.3|0.41
72448992|NCT05274074|144416038|SUPERIORITY||Mean Difference (Net)|-0.9||||0.45|TWO_SIDED|95.0|-3.5|1.6|||Regression, Linear|||||1.6|-3.5|0.45
72448993|NCT05274074|144416039|SUPERIORITY||Mean Difference (Net)|3.3||||0.02|TWO_SIDED|95.0|0.5|6.2|||Regression, Linear|||||6.2|0.5|0.02
72561663|NCT00178711|144654023|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.08|||=|0.67|TWO_SIDED|95.0|0.76|1.53|||Regression, Logistic|||The primary hypothesis was a two-sided test assessing whether the induction of hypothermia modified the percentage of subjects with poor outcomes at 6 months after injury. Percentages in each group were compared using a generalized linear model with a binomial distribution and log link function, logistic regression model with admission age and baseline GCS as covariates.||1.53|0.76|=0.67
72448994|NCT05274074|144416040|SUPERIORITY||Mean Difference (Net)|-0.8||||0.69|TWO_SIDED|95.0|-4.9|3.3|||Regression, Linear|||||3.3|-4.9|0.69
72448995|NCT01828099|144416042|SUPERIORITY||Hazard Ratio (HR)|0.55|||<|0.001|TWO_SIDED|95.0|0.42|0.73|||Log Rank|||||0.73|0.42|<0.001
72448996|NCT04642820|144416094|SUPERIORITY|||||||0.05|||||||t-test, 2 sided|||||||.05
72448997|NCT04568434|144416095|SUPERIORITY||LS mean difference|-43.5|||=|0.0009|TWO_SIDED|95.0|-69.085|-17.921||ANCOVA model included effects of treatment (olezarsen 80 mg, olezarsen 50 mg, or placebo): dependent variable, protocol specified 2 randomization stratification factors: fixed effects, log-transformed baseline TG: covariate.|ANCOVA|||||-17.921|-69.085|=0.0009
72448998|NCT04568434|144416095|SUPERIORITY||Least squares (LS) mean difference|-22.37|||=|0.0775|TWO_SIDED|95.0|-47.2|2.463||Analysis of covariance (ANCOVA) model included effects of treatment (olezarsen 80 mg, olezarsen 50 mg, or placebo): dependent variable, protocol specified 2 randomization stratification factors: fixed effects, log-transformed baseline TG: covariate.|ANCOVA|||||2.463|-47.200|=0.0775
72448999|NCT04568434|144416096|SUPERIORITY||LS mean difference|-43.81|||=|0.0044|TWO_SIDED|95.0|-73.928|-13.692||ANCOVA model included percent change from baseline in fasting TG at Month 12: dependent variable, treatment group, protocol specified 2 randomization stratification factors: fixed effects, log-transformed baseline TG: covariate.|ANCOVA|||||-13.692|-73.928|=0.0044
72449000|NCT04568434|144416096|SUPERIORITY||LS mean difference|-59.39|||=|0.0002|TWO_SIDED|95.0|-90.663|-28.119||ANCOVA model included percent change from baseline in fasting TG at Month 12: dependent variable, treatment group, protocol specified 2 randomization stratification factors: fixed effects, log-transformed baseline TG: covariate.|ANCOVA|||||-28.119|-90.663|=0.0002
72449001|NCT04568434|144416097|SUPERIORITY||LS mean difference|-65.48|||<|0.0001|TWO_SIDED|95.0|-82.634|-48.32||ANCOVA model included percent change from baseline in fasting apoC-III at Month 6: dependent variable, treatment group, protocol specified 2 randomization stratification factors: fixed effects, log-transformed baseline apoC-III: covariate.|ANCOVA|||Percent Change from Baseline at Month 6||-48.320|-82.634|<0.0001
72449002|NCT04568434|144416097|SUPERIORITY||LS mean difference|-73.69|||<|0.0001|TWO_SIDED|95.0|-94.553|-52.837||ANCOVA model included percent change from baseline in fasting apoC-III at Month 6: dependent variable, treatment group, protocol specified 2 randomization stratification factors: fixed effects, log-transformed baseline apoC-III: covariate.|ANCOVA|||Percent Change from Baseline at Month 6||-52.837|-94.553|<0.0001
72449003|NCT04568434|144416097|SUPERIORITY||Ls mean difference|-77.06|||<|0.0001|TWO_SIDED|95.0|-98.938|-55.177||ANCOVA model included percent change from baseline in fasting apoC-III at Month 12: dependent variable, treatment group, protocol specified 2 randomization stratification factors: fixed effects, log-transformed baseline apoC-III: covariate.|ANCOVA|||Percent Change from Baseline at Month 12||-55.177|-98.938|<0.0001
72449004|NCT04568434|144416097|SUPERIORITY||LS mean difference|-81.28|||<|0.0001|TWO_SIDED|95.0|-104.656|-57.894||ANCOVA model included percent change from baseline in fasting apoC-III at Month 12: dependent variable, treatment group, protocol specified 2 randomization stratification factors: fixed effects, log-transformed baseline apoC-III: covariate.|ANCOVA|||Percent Change from Baseline at Month 12||-57.894|-104.656|<0.0001
72449005|NCT04568434|144416099|SUPERIORITY||LS mean difference|-33.29|||=|0.186|TWO_SIDED|95.0|-82.612|16.041||ANCOVA model included percent change from baseline in fasting apoB-48 to Month 6: dependent variable, treatment group, protocol prespecified randomization stratification factors: fixed effects \& log-transformed baseline apoB-48: covariate.|ANCOVA|||Percent Change From Baseline at Month 6||16.041|-82.612|=0.1860
72622398|NCT01272219|144774698|SUPERIORITY_OR_OTHER||Estimated mean difference|-5.39|||<|0.0001|TWO_SIDED|95.0|-5.82|-4.95|||ANCOVA||ANCOVA model with treatment, country, sex, pre-diabetes status at screening, baseline BMI stratum and an interaction between pre-diabetes status at screening and BMI stratum as fixed factors, and the baseline value as covariate.|Null-hypothesis: no treatment difference between treatment arms, i.e. liraglutide 3.0 mg and liraglutide placebo. Liraglutide 3.0 mg was considered superior to placebo in inducing and maintaining weight loss, if the estimated treatment effect (liraglutide 3.0 mg - liraglutide placebo) was statistically significantly smaller than zero.||-4.95|-5.82|<0.0001
72449006|NCT04568434|144416099|SUPERIORITY||LS mean difference|-83.97|||=|0.0019|TWO_SIDED|95.0|-136.949|-30.982||ANCOVA model included percent change from baseline in fasting apoB-48 to Month 6: dependent variable, treatment group, protocol prespecified randomization stratification factors: fixed effects \& log-transformed baseline apoB-48: covariate.|ANCOVA|||Percent Change From Baseline at Month 6||-30.982|-136.949|=0.0019
72449007|NCT04568434|144416099|SUPERIORITY||LS mean difference|-32.9|||=|0.4219|TWO_SIDED|95.0|-113.254|47.459||ANCOVA model included percent change from baseline in fasting apoB-48 to Month 12: dependent variable, treatment group, protocol prespecified randomization stratification factors: fixed effects \& log-transformed baseline apoB-48: covariate.|ANCOVA|||Percent Change from Baseline at Month 12||47.459|-113.254|=0.4219
72449008|NCT04568434|144416099|SUPERIORITY||LS mean difference|-75.63|||=|0.056|TWO_SIDED|95.0|-153.195|1.927||ANCOVA model included percent change from baseline in fasting apoB-48 to Month 12: dependent variable, treatment group, protocol prespecified randomization stratification factors: fixed effects \& log-transformed baseline apoB-48: covariate.|ANCOVA|||Percent Change from Baseline at Month 12||1.927|-153.195|=0.0560
72449009|NCT04568434|144416100|SUPERIORITY||LS mean difference|-17.69|||=|0.0401|TWO_SIDED|95.0|-34.571|-0.801||ANCOVA model included percent change from baseline in fasting non-HDL-C to Month 6: dependent variable, treatment group, protocol prespecified randomization stratification factors: fixed effects \& log-transformed baseline non-HDL-C: covariate.|ANCOVA|||Percent Change from Baseline Month 6||-0.801|-34.571|=0.0401
72449010|NCT04568434|144416100|SUPERIORITY||LS mean difference|-24.2|||=|0.0036|TWO_SIDED|95.0|-40.484|-7.911||ANCOVA model included percent change from baseline in fasting non-HDL-C to Month 6: dependent variable, treatment group, protocol prespecified randomization stratification factors: fixed effects \& log-transformed baseline non-HDL-C: covariate|ANCOVA|||Percent Change from Baseline Month 6||-7.911|-40.484|=0.0036
72449011|NCT04568434|144416100|SUPERIORITY||LS mean difference|-29.84|||=|0.0134|TWO_SIDED|95.0|-53.49|-6.198||ANCOVA model included percent change from baseline in fasting non-HDL-C to Month 12: dependent variable, treatment group, protocol prespecified randomization stratification factors: fixed effects \& log-transformed baseline non-HDL-C: covariate.|ANCOVA|||Percent Change from Baseline at Month 12||-6.198|-53.490|=0.0134
72449012|NCT04568434|144416100|SUPERIORITY||LS mean difference|-39.7|||=|0.0009|TWO_SIDED|95.0|-63.108|-16.292||ANCOVA model included percent change from baseline in fasting non-HDL-C to Month 12: dependent variable, treatment group, protocol prespecified randomization stratification factors: fixed effects \& log-transformed baseline non-HDL-C: covariate.|ANCOVA|||Percent Change from Baseline at Month 12||-16.292|-63.108|=0.0009
72449013|NCT04568434|144416101|SUPERIORITY||Mean Rate Ratio|0.1|||=|0.0052|TWO_SIDED|95.0|0.02|0.506||Regression model: treatment group \& previous treatment (volanesorsen):factors adjudicated acute pancreatitis events in 5 years prior enrollment:covariate. Logarithm of time in year that each participant was observed from Week 1 to 53:offset variable.|Negative Binomial Regression Model|||||0.506|0.020|=0.0052
72449014|NCT04568434|144416102|SUPERIORITY||Mean Rate Ratio|0.12|||=|0.0144|TWO_SIDED|95.0|0.022|0.656||Regression model: treatment group \& previous treatment (volanesorsen):factors adjudicated acute pancreatitis events in 5 years prior enrollment:covariate. Logarithm of time in year that each participant was observed from Week 1 to 53:offset variable.|Negative Binomial Regression Model|||||0.656|0.022|=0.0144
72449015|NCT04568434|144416103|SUPERIORITY||Mean Rate Ratio|0.14|||=|0.0174|TWO_SIDED|95.0|0.028|0.709||Regression model: treatment group \& previous treatment (volanesorsen):factors adjudicated acute pancreatitis events in 5 years prior enrollment:covariate. Logarithm of time in year that each participant was observed from Week 13 to 53:offset variable|Negative Binomial Regression Model|||||0.709|0.028|=0.0174
72449016|NCT04568434|144416104|SUPERIORITY||Mean Rate Ratio|0.16|||=|0.0314|TWO_SIDED|95.0|0.031|0.85||Regression model: treatment group \& previous treatment (volanesorsen):factors adjudicated acute pancreatitis events in 5 years prior enrollment:covariate. Logarithm of time in year that each participant was observed from Week 13 to 53:offset variable|Negative Binomial Regression Model|||||0.850|0.031|=0.0314
72449017|NCT04568434|144416107|SUPERIORITY||Mean Rate Ratio|0.14|||=|0.0137|TWO_SIDED|95.0|0.029|0.669||Regression model: treatment group \& previous treatment (volanesorsen):factors adjudicated acute pancreatitis events in 5 years prior enrollment:covariate. Logarithm of time in year that each participant was observed from Week 1 to 53:offset variable|Negative Binomial Regression Model|||||0.669|0.029|=0.0137
72449018|NCT04568434|144416108|SUPERIORITY||Mean Rate Ratio|0.2|||=|0.048|TWO_SIDED|95.0|0.04|0.986||Regression model:treatment group \& previous treatment (volanesorsen):factors adjudicated acute pancreatitis events in 5 years prior enrollment:covariate. Logarithm of time in year that each participant was observed from Week 13 to 53:offset variable|Negative Binomial Regression Model|||||0.986|0.040|=0.0480
72449019|NCT05469464|144416110|SUPERIORITY||Mean Difference (Net)|-4.6|STANDARD_ERROR_OF_MEAN|6.93||0.505|TWO_SIDED|95.0|-18.2|9.0|||ANCOVA|||||9.0|-18.2|0.505
72449020|NCT05469464|144416110|SUPERIORITY||Mean Difference (Net)|-1.7|STANDARD_ERROR_OF_MEAN|7.15||0.812|TWO_SIDED|95.0|-15.8|12.3|||ANCOVA|||||12.3|-15.8|0.812
72449021|NCT05469464|144416110|SUPERIORITY||Mean Difference (Net)|-10.9|STANDARD_ERROR_OF_MEAN|6.99||0.118|TWO_SIDED|95.0|-24.6|2.8|||ANCOVA|||||2.8|-24.6|0.118
72449022|NCT06473662|144416159|OTHER||Mean Difference (Final Values)|-0.53||||0.0039|TWO_SIDED||||||t-test, 2 sided|||||||0.0039
72449023|NCT06473662|144416160|OTHER||Mean Difference (Final Values)|-18.8||||0.0166|TWO_SIDED||||||t-test, 2 sided|||||||0.0166
72449024|NCT06473662|144416162|OTHER||Mean Difference (Final Values)|-22.13||||0.0474|TWO_SIDED||||||ANCOVA|||||||0.0474
72498664|NCT01795547|144527734|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.695||||0.095|TWO_SIDED|95.0|-1.511|0.121||All secondary endpoints were tested without any hierarchical testing strategy and no adjustment for multiplicity|Mixed Models Analysis|The model uses an unstructured variance/covariance matrix.||||0.121|-1.511|0.095
72504803|NCT03114969|144540515|SUPERIORITY||Odds Ratio (OR)|4.269||||0.078|TWO_SIDED|95.0|0.848|21.489||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta+\[Relvar Ellipta+LAMA\] as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.|||21.489|0.848|0.078
72561664|NCT01992094|144654043|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the upper bound of the two-sided 95% confidence interval (CI) for the ratio of GMTs (GMT TIV1c/GMT QIVc) for HI antibody does not exceed the non-inferiority margin of 1.5|Ratios of GMT|1.0|||||TWO_SIDED|95.0|0.9|1.1|||ANCOVA|||Non-inferiority of immune responses of QIVc to TIV1c, assessed in terms of ratios of GMT against influenza strain H1N1||1.1|0.9|
72561665|NCT01992094|144654043|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the upper bound of the two-sided 95% confidence interval (CI) for the ratio of GMTs (GMT TIV1c/GMT QIVc) for HI antibody does not exceed the non-inferiority margin of 1.5|Ratios of GMT|1.0|||||TWO_SIDED|95.0|0.9|1.1|||ANCOVA|||Non-inferiority of immune responses of QIVc to TIV1c, assessed in terms of ratios of GMT against influenza strain H3N2||1.1|0.9|
72561666|NCT01992094|144654043|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the upper bound of the two-sided 95% confidence interval (CI) for the ratio of GMTs (GMT TIV1c/GMT QIVc) for HI antibody does not exceed the non-inferiority margin of 1.5|Ratios of GMT|0.9|||||TWO_SIDED|95.0|0.8|1.0|||ANCOVA|||Non-inferiority of immune responses of QIVc to TIV1c, assessed in terms of ratios of GMT against influenza strain B1||1.0|0.8|
72561667|NCT01992094|144654043|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the upper bound of the two-sided 95% confidence interval (CI) for the ratio of GMTs (GMT TIV2c/GMT QIVc) for HI antibody does not exceed the non-inferiority margin of 1.5|Ratios of GMT|0.9|||||TWO_SIDED|95.0|0.9|1.0|||ANCOVA|||Non-inferiority of immune responses of QIVc to TIV2c, assessed in terms of ratios of GMT against influenza strain B2||1.0|0.9|
72561668|NCT01992094|144654044|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the upper bound of the two-sided 95% CI for the difference between seroconversion rates (% seroconversion TIV1c - % seroconversion QIVc) for HI antibody does not exceed the margin of 10%|Difference between seroconversion rates|-0.5|||||TWO_SIDED|95.0|-5.3|4.2|||ANCOVA|||Non-inferiority of immune responses of QIVc to TIV1c in terms of differences in seroconversion rates against influenza strain H1N1||4.2|-5.3|
72561669|NCT01992094|144654044|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the upper bound of the two-sided 95% CI for the difference between seroconversion rates (% seroconversion TIV1c - % seroconversion QIVc) for HI antibody does not exceed the margin of 10%|Difference between seroconversion rates|-2.7|||||TWO_SIDED|95.0|-7.2|1.9|||ANCOVA|||Non-inferiority of immune responses of QIVc to TIV1c in terms of differences in seroconversion rates against influenza strainH3N2||1.9|-7.2|
72561670|NCT01992094|144654044|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the upper bound of the two-sided 95% CI for the difference between seroconversion rates (% seroconversion TIV1c - % seroconversion QIVc) for HI antibody does not exceed the margin of 10%|Difference between seroconversion rates|-1.8|||||TWO_SIDED|95.0|-6.2|2.8|||ANCOVA|||Non-inferiority of immune responses of QIVc to TIV1c in terms of differences in seroconversion rates against influenza strain B1||2.8|-6.2|
72619542|NCT03537729|144769952|SUPERIORITY|Power was based on planned 12 sites and effect size Cohen's d=0.42 for pairwise differences between arms, intraclass correlation coefficient of 0.0012, and reduction in variance due to adjustment for baseline and repeated measures with correlation of 0.4 between pairs of measures. The sample size requirement was 38 per group, or 114 total for power of .80 in two-sided tests at .05 level of significance.|Mean Difference (Final Values)|0.55|STANDARD_ERROR_OF_MEAN|0.19|<|0.01|TWO_SIDED|95.0|0.18|0.91||P-value was not adjusted for multiple comparisons. A priori threshold for statistical significance was .05.|Mixed Models Analysis|Covariates included baseline value of the outcome, age, sex, and cognition score at baseline, and use of wheelchair on the route.|Cues minus control|The null hypothesis was that means of two arms on the low complexity route are equal, the alternative was that means were not equal.||0.91|0.18|<.01
72449025|NCT05485779|144416173|EQUIVALENCE|Study was not powered and confidence intervals were assessed for containing unity (1) within them.|Slope|1.17||||0.6358|TWO_SIDED|95.0|1.07|1.27|||Lack of fit 2-sided|Lack of Fit Model: ln(parameter) = intercept + slope × ln(dose) + dose + random error|Between-subject geometric coefficient of variation was 30.4. Data were analyzed using a power model. ln(parameter) = intercept + slope ×ln(dose) + random error.|Statistical Analysis of AQ280 Primary Pharmacokinetic Endpoints to Assess Dose Proportionality of Single Oral Doses of 3 to 60 mg AQ280||1.27|1.07|0.6358
72449026|NCT05485779|144416173|EQUIVALENCE|Study was not powered and confidence intervals were assessed for containing unity (1) within them.|Slope|1.13||||0.5506|TWO_SIDED|95.0|0.963|1.31|||Lack of Fit 2-sided|Lack of Fit Model: ln(parameter) = intercept + slope × ln(dose) + dose + random error|Between-subject geometric coefficient of variation was 32.9. Data were analyzed using a power model. ln(parameter) = intercept + slope ×ln(dose) + random error.|Statistical Analysis of AQ280 Primary Pharmacokinetic Endpoints to Assess Dose Proportionality of Single Oral Doses of 9 to 60 mg AQ280||1.31|0.963|0.5506
72449027|NCT05485779|144416174|EQUIVALENCE|Study was not powered and confidence intervals were assessed for containing unity (1) within them.|Slope|1.13||||0.3653|TWO_SIDED|95.0|1.04|1.22|||Lack of Fit 2-sided|Lack of Fit Model: ln(parameter) = intercept + slope × ln(dose) + dose + random error|Between-subject geometric coefficient of variation was 25.7. Data were analyzed using a power model. ln(parameter) = intercept + slope ×ln(dose) + random error|Statistical Analysis of AQ280 Primary Pharmacokinetic Endpoints to Assess Dose Proportionality of Single Oral Doses of 3 to 60 mg AQ280||1.22|1.04|0.3653
72449028|NCT05485779|144416174|EQUIVALENCE|Study was not powered and confidence intervals were assessed for containing unity (1) within them.|Slope|1.16||||0.2933|TWO_SIDED|95.0|1.01|1.31|||Lack of Fit 2-sided|Lack of Fit Model: ln(parameter) = intercept + slope × ln(dose) + dose + random error|Between-subject geometric coefficient of variation was 27.7. Data were analyzed using a power model. ln(parameter) = intercept + slope ×ln(dose) + random error|Statistical Analysis of AQ280 Primary Pharmacokinetic Endpoints to Assess Dose Proportionality of Single Oral Doses of 9 to 60 mg AQ280||1.31|1.01|0.2933
72561671|NCT01992094|144654044|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the upper bound of the two-sided 95% CI for the difference between seroconversion rates (% seroconversion TIV2c - % seroconversion QIVc) for HI antibody does not exceed the margin of 10%|Difference between seroconversion rates|-4.4|||||TWO_SIDED|95.0|-8.9|0.2|||ANCOVA|||Non-inferiority of immune responses of QIVc to TIV2c in terms of differences in seroconversion rates against influenza strain B2||0.2|-8.9|
72561672|NCT01992094|144654050|NON_INFERIORITY_OR_EQUIVALENCE|The upper bound of the 2-sided 95% CI for the ratio of GMTs (GMT TIV1c or TIV2c /GMT QIVc) for HI antibody should not exceed the superiority margin of 1.|Ratios of GMT|0.6|||||TWO_SIDED|95.0|0.6|0.7||||||Superiority of immune responses of QIVc to TIV1c in terms of ratios of GMT against influenza strain B2||0.7|0.6|
72449029|NCT05485779|144416175|EQUIVALENCE|Study was not powered and confidence intervals were assessed for containing unity (1) within them.|Slope|1.16||||0.46|TWO_SIDED|95.0|0.908|1.41|||Lack of Fit 2-sided|Lack of Fit Model: ln(parameter) = intercept + slope × ln(dose) + dose + random error|Between-subject geometric coefficient of variation was 64.3. Data were analyzed using a power model. ln(parameter) = intercept + slope ×ln(dose) + random error|Statistical Analysis of Metabolite AQ282 Primary Pharmacokinetic Endpoints to Assess Dose Proportionality of Single Oral Doses of 3 to 60 mg AQ280||1.41|0.908|0.4600
72449030|NCT05485779|144416175|EQUIVALENCE|Study was not powered and confidence intervals were assessed for containing unity (1) within them.|Slope|1.12||||0.3157|TWO_SIDED|95.0|0.795|1.45|||Lack of Fit 2-sided|Lack of Fit Model: ln(parameter) = intercept + slope × ln(dose) + dose + random error|Between-subject geometric coefficient of variation was 65.6. Data were analyzed using a power model. ln(parameter) = intercept + slope ×ln(dose) + random error|Statistical Analysis of Metabolite AQ282 Primary Pharmacokinetic Endpoints to Assess Dose Proportionality of Single Oral Doses of 9 to 60 mg AQ280||1.45|0.795|0.3157
72449031|NCT05485779|144416176|EQUIVALENCE|Study was not powered and confidence intervals were assessed for containing unity (1) within them.|Slope|1.2||||0.235|TWO_SIDED|95.0|1.02|1.37|||Lack of fit 1-sided p-value|Lack of Fit Model: ln(parameter) = intercept + slope × ln(dose) + dose + random error|Between-subject geometric coefficient of variation was 54.2. Data were analyzed using a power model. ln(parameter) = intercept + slope ×ln(dose) + random error.|Statistical Analysis of Metabolite AQ282 Primary Pharmacokinetic Endpoints to Assess Dose Proportionality of Single Oral Doses of 3 to 60 mg AQ280||1.37|1.02|0.2350
72449032|NCT05485779|144416176|EQUIVALENCE|Study was not powered and confidence intervals were assessed for containing unity (1) within them.|Slope|1.19||||0.1632|TWO_SIDED|95.0|0.88|1.5|||Lack of fit 1-sided p-value|Lack of Fit Model: ln(parameter) = intercept + slope × ln(dose) + dose + random error|Between-subject geometric coefficient of variation was 58.5. Data were analyzed using a power model. ln(parameter) = intercept + slope ×ln(dose) + random error.|Statistical Analysis of Metabolite AQ282 Primary Pharmacokinetic Endpoints to Assess Dose Proportionality of Single Oral Doses of 9 to 60 mg AQ280||1.50|0.880|0.1632
72449033|NCT05485779|144416177|EQUIVALENCE|Study was not powered and confidence intervals were assessed for containing unity (1) within them.|Ratio of geometric least squares mean|0.977|||||TWO_SIDED|90.0|0.915|1.04|||||Within-subject geometric coefficient of variation was 5.66. Data analyzed using a mixed model included treatment as a fixed effect and subject as a random effect. ln(parameter)=treatment+subject+random error, with subject fitted as a random effect.|Statistical Analysis of AQ280 Primary Pharmacokinetic Endpoints to Assess the Effect of Food on Single Oral Doses of 16 mg AQ280||1.04|0.915|
72449034|NCT05485779|144416178|EQUIVALENCE|Study was not powered and confidence intervals were assessed for containing unity (1) within them.|Ratio of geometric least squares mean|0.805|||||TWO_SIDED|90.0|0.635|1.02|||||Within-subject geometric coefficient of variation was 20.5. Data analyzed using a mixed model included treatment as a fixed effect and subject as a random effect. ln(parameter)=treatment+subject+random error, with subject fitted as a random effect.|Statistical Analysis of AQ280 Primary Pharmacokinetic Endpoints to Assess the Effect of Food on Single Oral Doses of 16 mg AQ280||1.02|0.635|
72449035|NCT05485779|144416180|EQUIVALENCE|Study was not powered and confidence intervals were assessed for containing unity (1) within them.|Slope|1.15||||0.1558|TWO_SIDED|95.0|0.954|1.34|||Lack of fit 2-sided|Lack of Fit Model: ln(parameter) = intercept + slope × ln(dose) + dose + random error|Between-subject geometric coefficient of variation was 28.0. Data were analyzed using a power model. ln(parameter) = intercept + slope ×ln(dose) + random error|Statistical Analysis of AQ280 Primary Pharmacokinetic Endpoints to Assess Dose Proportionality of Multiple Oral Doses of 9 to 60 mg AQ280 QD for 7 Consecutive Days in a Fasted State||1.34|0.954|0.1558
72449036|NCT05485779|144416181|EQUIVALENCE|Study was not powered and confidence intervals were assessed for containing unity (1) within them.|Slope|1.1||||0.5458|TWO_SIDED|95.0|0.946|1.26|||Lack of Fit 2-sided model|Lack of Fit Model: ln(parameter) = intercept + slope × ln(dose) + dose + random error|Between-subject geometric coefficient of variation was 24.0. Data were analyzed using a power model. ln(parameter) = intercept + slope ×ln(dose) + random error|Statistical Analysis of AQ280 Primary Pharmacokinetic Endpoints to Assess Dose Proportionality of Multiple Oral Doses of 9 to 60 mg AQ280 QD for 7 Consecutive Days in a Fasted State||1.26|0.946|0.5458
72449037|NCT05485779|144416182|EQUIVALENCE|Study was not powered and confidence intervals were assessed for containing unity (1) within them.|Slope|0.941||||0.4856|TWO_SIDED|95.0|0.602|1.28||Lack of Fit Model: ln(parameter) = intercept + slope × ln(dose) + dose + random error|Lack of fit 2-sided||Between-subject geometric coefficient of variation was 54.7. Data were analyzed using a power model. ln(parameter) = intercept + slope ×ln(dose) + random error.|Statistical Analysis of Metabolite AQ282 Primary Pharmacokinetic Endpoints to Assess Dose Proportionality of Multiple Oral Doses of 9 to 60 mg AQ280 once daily for 7 Consecutive Days in a Fasted State||1.28|0.602|0.4856
72449038|NCT05485779|144416183|EQUIVALENCE|Study was not powered and confidence intervals were assessed for containing unity (1) within them.|Slope|0.971||||0.1455|TWO_SIDED|95.0|0.666|1.28|||Lack of fit 2-sided|Lack of Fit Model: ln(parameter) = intercept + slope × ln(dose) + dose + random error|Between-subject geometric coefficient of variation was 45.5. Data were analyzed using a power model. ln(parameter) = intercept + slope ×ln(dose) + random error.|Statistical Analysis of Metabolite AQ282 Primary Pharmacokinetic Endpoints to Assess Dose Proportionality of Multiple Oral Doses of 9 to 60 mg AQ280 once daily for 7 Consecutive Days in a Fasted State||1.28|0.666|0.1455
72561673|NCT01992094|144654051|NON_INFERIORITY_OR_EQUIVALENCE|The upper bound of the 2-sided 95% CI for the difference between seroconversion rates (% seroconversion TIV1c or TIV2c - % seroconversion QIVc) for HI antibody should not exceed the margin of 0 points.|Difference between seroconversion rates|-19.4|||||TWO_SIDED|95.0|-23.2|-15.5||||||Superiority of immune responses of QIVc to TIV1c in terms of seroconversion rates against influenza strain B2||-15.5|-23.2|
72561674|NCT01992094|144654052|NON_INFERIORITY_OR_EQUIVALENCE|The upper bound of the 2-sided 95% CI for the ratio of GMTs (GMT TIV1c or TIV2c /GMT QIVc) for HI antibody should not exceed the superiority margin of 1.|Ratios of GMT|0.5|||||TWO_SIDED|95.0|0.5|0.5||||||Superiority of immune responses of QIVc to TIV2c in terms of ratios of GMT against influenza strain B1||0.5|0.5|
72449039|NCT05192109|144416194|OTHER||||||<|0.01||||||This is the p-value for the simple effect of condition.|Regression, Linear|||The primary statistical analysis involves asking whether children's preference to look at the target is significantly greater in one condition and/or group than the other. Mixed-effects regression analyses are used with the proportion-empirical-logit transformed-of target looking as the dependent measure, participant as random effect, and condition and group and their interaction as fixed effects.||||<0.01
72449040|NCT05192109|144416194|OTHER|||||||0.93||||||This is the p-value for the simple effect of diagnostic group.|Regression, Linear|||The primary statistical analysis involves asking whether children's preference to look at the target is significantly greater in one condition and/or group than the other. Mixed-effects regression analyses are used with the proportion-empirical-logit transformed-of target looking as the dependent measure, participant as random effect, and condition and group and their interaction as fixed effects.||||0.93
72449041|NCT05192109|144416194|OTHER||||||<|0.01||||||This is the p-value for the interaction between condition and group.|Regression, Linear|||The primary statistical analysis involves asking whether children's preference to look at the target is significantly greater in one condition and/or group than the other. Mixed-effects regression analyses are used with the proportion-empirical-logit transformed-of target looking as the dependent measure, participant as random effect, and condition and group and their interaction as fixed effects.||||<0.01
72449042|NCT05192109|144416195|OTHER||||||<|0.01||||||This is the p-value for the simple effect of condition.|Regression, Linear|||The primary statistical analysis involves asking whether children's preference to look at the target is significantly greater in one condition and/or group than the other. Mixed-effects regression analyses are used with the proportion-empirical-logit transformed-of target looking as the dependent measure, participant as random effect, and condition and group and their interaction as fixed effects.||||<0.01
72449043|NCT05192109|144416195|OTHER|||||||0.22||||||This is the p-value for the simple effect of group.|Regression, Linear|||The primary statistical analysis involves asking whether children's preference to look at the target is significantly greater in one condition and/or group than the other. Mixed-effects regression analyses are used with the proportion-empirical-logit transformed-of target looking as the dependent measure, participant as random effect, and condition and group and their interaction as fixed effects.||||0.22
72449044|NCT05192109|144416195|OTHER||||||<|0.01||||||This is the p-value for the interaction between condition and group.|Regression, Linear|||The primary statistical analysis involves asking whether children's preference to look at the target is significantly greater in one condition and/or group than the other. Mixed-effects regression analyses are used with the proportion-empirical-logit transformed-of target looking as the dependent measure, participant as random effect, and condition and group and their interaction as fixed effects.||||<0.01
72498665|NCT01813890|144527757|SUPERIORITY_OR_OTHER||Mean Difference (Net)|105.61||||0.006|TWO_SIDED|95.0|32.0|179.2||P-value adjusted for multiple treatment group comparisons using the Hochberg method.|ANCOVA|ANCOVA model with treatment group and center as factors and baseline pain intensity as covariate.|Difference is SPID48 in tapentadol IR group minus SPID48 in placebo group|Based on participant availability in Taiwan it was expected that 60 subjects (20 per group) would be enrolled. In consultation with the Taiwan health authority, the overall two-sided significance level was set at 0.20 (0.10 for each tapentadol versus placebo comparison). Assuming a standard deviation of 134.4, this sample size would provide 71.5% power to detect a between-group difference in SPID48 of 94.1 and 81.2% power to detect a between-group difference of 107.52.||179.2|32.0|0.006
72498666|NCT01813890|144527757|SUPERIORITY_OR_OTHER||Median Difference (Net)|126.58||||0.004|TWO_SIDED|95.0|49.5|203.7||P-value adjusted for multiple treatment group comparisons using the Hochberg method.|ANCOVA|ANCOVA model with treatment group and center as factors and baseline pain intensity as covariate.|Difference is SPID48 in tapentadol IR group minus SPID48 in placebo group.|Based on participant availability in Taiwan it was expected that 60 subjects (20 per group) would be enrolled. In consultation with the Taiwan health authority, the overall two-sided significance level was set at 0.20 (0.10 for each tapentadol versus placebo comparison). Assuming a standard deviation of 134.4, this sample size would provide 71.5% power to detect a between-group difference in SPID48 of 94.1 and 81.2% power to detect a between-group difference of 107.52.||203.7|49.5|0.004
72498667|NCT03952559|144527765|SUPERIORITY||Odds Ratio (OR)|1.13||||0.7261|TWO_SIDED|95.0|0.58|2.21|||Regression, Logistic|||||2.21|0.58|0.7261
72498668|NCT03952559|144527765|SUPERIORITY||Odds Ratio (OR)|1.8||||0.0718|TWO_SIDED|95.0|0.95|3.41|||Regression, Logistic|||||3.41|0.95|0.0718
72498669|NCT03952559|144527765|SUPERIORITY||Odds Ratio (OR)|3.73|||<|0.0001|TWO_SIDED|95.0|2.02|6.89|||Regression, Logistic|||||6.89|2.02|<0.0001
72498670|NCT03952559|144527768|SUPERIORITY||Odds Ratio (OR)|1.01||||0.9615|TWO_SIDED|95.0|0.59|1.74|||Regression, Logistic|||||1.74|0.59|0.9615
72498671|NCT03952559|144527768|SUPERIORITY||Odds Ratio (OR)|1.42||||0.201|TWO_SIDED|95.0|0.83|2.41|||Regression, Logistic|||||2.41|0.83|0.2010
72498672|NCT03952559|144527768|SUPERIORITY||Odds Ratio (OR)|2.33||||0.0017|TWO_SIDED|95.0|1.38|3.95|||Regression, Logistic|||||3.95|1.38|0.0017
72449045|NCT05170841|144416209|SUPERIORITY||||||=|0.566|||||||t-test, 2 sided|||||||=0.566
72449046|NCT05170841|144416210|SUPERIORITY||||||=|0.013|||||||t-test, 2 sided|||||||=0.013
72449047|NCT05170841|144416211|SUPERIORITY||||||=|0.006|||||||t-test, 2 sided|||||||=0.006
72498673|NCT03952559|144527769|SUPERIORITY||Odds Ratio (OR)|0.93||||0.8544|TWO_SIDED|95.0|0.43|2.01|||Regression, Logistic|||||2.01|0.43|0.8544
72498674|NCT03952559|144527769|SUPERIORITY||Odds Ratio (OR)|1.96||||0.0561|TWO_SIDED|95.0|0.98|3.91|||Regression, Logistic|||||3.91|0.98|0.0561
72498675|NCT03952559|144527769|SUPERIORITY||Odds Ratio (OR)|2.99||||0.0012|TWO_SIDED|95.0|1.54|5.82|||Regression, Logistic|||||5.82|1.54|0.0012
72498676|NCT03952559|144527770|SUPERIORITY||LS Mean difference (Final Values)|-1.51|STANDARD_ERROR_OF_MEAN|1.349||0.2627|TWO_SIDED|95.0|-4.16|1.14|||Mixed Models Analysis|||||1.14|-4.16|0.2627
72498677|NCT03952559|144527770|SUPERIORITY||LS Mean difference (Final Values)|-1.67|STANDARD_ERROR_OF_MEAN|1.342||0.2135|TWO_SIDED|95.0|-4.31|0.97|||Mixed Models Analysis|||||0.97|-4.31|0.2135
72498678|NCT03952559|144527770|SUPERIORITY||LS Mean difference (Final Values)|-2.72|STANDARD_ERROR_OF_MEAN|1.347||0.0443|TWO_SIDED|95.0|-5.36|-0.07|||Mixed Models Analysis|||||-0.07|-5.36|0.0443
72498679|NCT03952559|144527771|SUPERIORITY||Odds Ratio (OR)|0.73||||0.4943|TWO_SIDED|95.0|0.3|1.78|||Regression, Logistic|||||1.78|0.30|0.4943
72498680|NCT03952559|144527771|SUPERIORITY||Odds Ratio (OR)|1.72||||0.1677|TWO_SIDED|95.0|0.8|3.7|||Regression, Logistic|||||3.70|0.80|0.1677
72622399|NCT01272219|144774699|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.8|||<|0.0001|TWO_SIDED|95.0|4.12|5.6|||Regression, Logistic||The model included treatment, country, sex, pre-diabetes status at screening, BMI stratum and an interaction between pre-diabetes status at screening and BMI stratum as fixed factors, and the baseline value as covariate.|Null-hypothesis: no treatment difference between treatment arms, i.e. liraglutide 3.0 mg and liraglutide placebo. Liraglutide 3.0 mg was considered superior to placebo in inducing and maintaining weight loss as assessed by the proportion of subjects losing ≥5% of their fasting baseline weight, if the estimated odds ratio (liraglutide 3.0 mg/liraglutide placebo) was statistically significantly greater than one.||5.60|4.12|<0.0001
72449048|NCT05170841|144416212|SUPERIORITY||||||=|0.013|||||||t-test, 2 sided|||||||=0.013
72449049|NCT05170841|144416213|SUPERIORITY||||||=|0.031|||||||t-test, 2 sided|||||||=0.031
72449050|NCT05170841|144416214|SUPERIORITY||||||=|0.027|||||||t-test, 2 sided|||||||=0.027
72449051|NCT05170841|144416215|SUPERIORITY||||||=|0.011|||||||t-test, 2 sided|||||||=0.011
72449052|NCT05170841|144416216|SUPERIORITY||||||=|0.007|||||||t-test, 2 sided|||||||=0.007
72449053|NCT05170841|144416217|SUPERIORITY||||||=|0.013|||||||t-test, 2 sided|||||||=0.013
72449054|NCT05170841|144416218|SUPERIORITY||||||=|0.029|||||||t-test, 2 sided|||||||=0.029
72449055|NCT05170841|144416219|SUPERIORITY||||||=|0.022|||||||t-test, 2 sided|||||||=0.022
72449056|NCT05170841|144416220|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
72498681|NCT03952559|144527771|SUPERIORITY||Odds Ratio (OR)|2.24||||0.0336|TWO_SIDED|95.0|1.06|4.7|||Regression, Logistic|||||4.70|1.06|0.0336
72498682|NCT03952559|144527772|SUPERIORITY||Odds Ratio (OR)|1.07||||0.8866|TWO_SIDED|95.0|0.42|2.77|||Regression, Logistic|||||2.77|0.42|0.8866
72449057|NCT05170841|144416221|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
72449058|NCT05170841|144416222|SUPERIORITY||||||=|0.001|||||||t-test, 2 sided|||||||=0.001
72449059|NCT05170841|144416223|SUPERIORITY||||||=|0.01|||||||t-test, 2 sided|||||||=0.01
72449060|NCT05170841|144416224|SUPERIORITY||||||=|0.04|||||||t-test, 2 sided|||||||=0.04
72449061|NCT05170841|144416225|SUPERIORITY||||||=|0.016|||||||t-test, 2 sided|||||||=0.016
72449062|NCT05170841|144416226|SUPERIORITY||||||=|0.045|||||||t-test, 2 sided|||||||=0.045
72498683|NCT03952559|144527772|SUPERIORITY||Odds Ratio (OR)|1.73||||0.2316|TWO_SIDED|95.0|0.7|4.26|||Regression, Logistic|||||4.26|0.70|0.2316
72498684|NCT03952559|144527772|SUPERIORITY||Odds Ratio, log|2.59||||0.0328|TWO_SIDED|95.0|1.08|6.22|||Regression, Logistic|||||6.22|1.08|0.0328
72449063|NCT05170841|144416227|SUPERIORITY||||||=|0.042|||||||t-test, 2 sided|||||||=0.042
72498685|NCT03952559|144527773|SUPERIORITY||Odds Ratio (OR)|1.18||||0.5361|TWO_SIDED|95.0|0.7|1.98|||Regression, Logistic|||||1.98|0.70|0.5361
72498686|NCT03952559|144527773|SUPERIORITY||Odds Ratio (OR)|1.23||||0.4417|TWO_SIDED|95.0|0.73|2.06|||Regression, Logistic|||||2.06|0.73|0.4417
72449064|NCT05170841|144416228|SUPERIORITY||||||=|0.037|||||||t-test, 2 sided|||||||=0.037
72449065|NCT05170841|144416229|SUPERIORITY||||||=|0.045|||||||t-test, 2 sided|||||||=0.045
72449066|NCT05170841|144416230|SUPERIORITY||||||=|0.029|||||||t-test, 2 sided|||||||=0.029
72449067|NCT05170841|144416231|SUPERIORITY||||||=|0.027|||||||t-test, 2 sided|||||||=0.027
72449068|NCT05170841|144416232|SUPERIORITY||||||=|0.035|||||||t-test, 2 sided|||||||=0.035
72449069|NCT05170841|144416233|SUPERIORITY||||||=|0.001|||||||t-test, 2 sided|||||||=0.001
72449070|NCT04865289|144416235|OTHER|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate.|Hazard Ratio (HR)|0.85|||||TWO_SIDED|95.0|0.51|1.41||||||||1.41|0.51|
72449071|NCT04865289|144416236|OTHER|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate.|Hazard Ratio (HR)|0.76|||||TWO_SIDED|95.0|0.48|1.21||||||||1.21|0.48|
72449072|NCT04865289|144416237|NON_INFERIORITY|The null hypothesis for the non-inferiority test was that the hazard ratio was equal to 1.1.|Hazard Ratio (HR)|1.17||||0.5831415|TWO_SIDED|95.0|0.64|2.15|||Log Rank|One-sided p-value based on log-rank test.|Based on Cox regression model with Efron's method for tie handling with treatment as a covariate.|||2.15|0.64|0.5831415
72449073|NCT04865289|144416237|SUPERIORITY||Hazard Ratio (HR)|1.17||||0.6980186|TWO_SIDED|95.0|0.64|1.26|||Log Rank|One-sided p-value based on log-rank test.|Based on Cox regression model with Efron's method for tie handling with treatment as a covariate.|||1.26|0.64|0.6980186
72449074|NCT04865289|144416238|SUPERIORITY||Hazard Ratio (HR)|1.01||||0.52046|TWO_SIDED|95.0|0.57|1.8|||Log Rank|One-sided p-value based on log-rank test.|Based on Cox regression model with Efron's method for tie handling with treatment as a covariate.|||1.80|0.57|0.52046
72449075|NCT04865289|144416239|OTHER||Difference in Percentage|-10.5||||0.8497|TWO_SIDED|95.0|-29.2|9.3|||Miettinen & Nurminen|One sided p value for testing. H0: difference in % = 0 versus H1: difference in % \> 0.||||9.3|-29.2|0.8497
72449076|NCT04865289|144416240|OTHER||Difference in Percentage|-9.1||||0.8522|TWO_SIDED|95.0|-25.5|8.0|||Miettinen & Nurminen|One sided p value for testing. H0: difference in % = 0 versus H1: difference in % \> 0.||||8.0|-25.5|0.8522
72449077|NCT04865289|144416241|OTHER|Based on a cLDA model with the PRO scores as the response variable with covariates for treatment by study visit interaction.|Difference in Least Square Means|-2.14||||0.6138|TWO_SIDED|95.0|-10.54|6.27|||cLDA model|||||6.27|-10.54|0.6138
72449078|NCT04865289|144416242|OTHER|Based on a cLDA model with the PRO scores as the response variable with covariates for treatment by study visit interaction.|Difference in Least Square Means|-0.73||||0.8398|TWO_SIDED|95.0|-7.93|6.46|||cLDA model|||||6.46|-7.93|0.8398
72449079|NCT06201559|144416247|EQUIVALENCE|Point estimate of geometric mean ratio (GMR) of T/R should be between 80.00 -125.00%. If the intra-subject variability for Cmax following replicate administrations of the comparator product was \> 30%, the acceptance criteria for Cmax was widened to a maximum of 69.84-143.19%.|Ratio of Geometric Least Square Means|98.1|||||TWO_SIDED|90.0|86.79|110.91|||||Geometric least square means were combined to perform statistical analysis of T as T1 + T2 and R as R1 + R2.|||110.91|86.79|
72498687|NCT03952559|144527773|SUPERIORITY||Odds Ratio (OR)|2.0||||0.0121|TWO_SIDED|95.0|1.16|3.43|||Regression, Logistic|||||3.43|1.16|0.0121
72498688|NCT03952559|144527774|SUPERIORITY||Odds Ratio (OR)|1.19||||0.7706|TWO_SIDED|95.0|0.37|3.78|||Regression, Logistic|||||3.78|0.37|0.7706
72498689|NCT03952559|144527774|SUPERIORITY||Odds Ratio (OR)|1.22||||0.7409|TWO_SIDED|95.0|0.38|3.86|||Regression, Logistic|||||3.86|0.38|0.7409
72498690|NCT03952559|144527774|SUPERIORITY||Odds Ratio (OR)|3.15||||0.0253|TWO_SIDED|95.0|1.15|8.63|||Regression, Logistic|||||8.63|1.15|0.0253
72449080|NCT06201559|144416248|EQUIVALENCE|Point estimate of geometric mean ratio (GMR) of T/R should be between 80.00 -125.00%. If the intra-subject variability for AUC(0-t) following replicate administrations of the comparator product was \> 30%, the acceptance criteria for AUC(0-t) was widened to a maximum of 69.84-143.19%.|Ratio of Geometric Least Square Means|97.6|||||TWO_SIDED|90.0|86.86|109.73|||||Geometric least square means were combined to perform statistical analysis of T as T1 + T2 and R as R1 + R2.|||109.73|86.86|
72449081|NCT06122194|144416272|OTHER||Ratio of Adjusted Geometric Means|112.15|||||TWO_SIDED|90.0|93.01|135.22||||||Natural log transformed Cmax for PF-07817883 were analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect in Periods 1 to 4. The ratio (Test/Reference) and 90 percent (%) confidence intervals (CIs) were expressed as percentages.||135.22|93.01|
72449082|NCT06122194|144416272|OTHER||Ratio of Adjusted Geometric Means|187.37|||||TWO_SIDED|90.0|155.79|225.35||||||Natural log transformed Cmax for PF-07817883 were analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect in Periods 1 to 4. The ratio (Test/Reference) and 90% CIs were expressed as percentages.||225.35|155.79|
72449083|NCT06122194|144416272|OTHER||Ratio of Adjusted Geometric Means|153.61|||||TWO_SIDED|90.0|127.4|185.21||||||Natural log transformed Cmax for PF-07817883 were analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect in Periods 1 to 4. The ratio (Test/Reference) and 90% CIs were expressed as percentages.||185.21|127.40|
72449084|NCT06122194|144416273|OTHER||Ratio of Adjusted Geometric Means|102.59|||||TWO_SIDED|90.0|91.09|115.54||||||Natural log transformed AUCinf for PF-07817883 were analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect in Periods 1 to 4. The ratio (Test/Reference) and 90% CIs were expressed as percentages.||115.54|91.09|
72449085|NCT06122194|144416273|OTHER||Ratio of Adjusted Geometric Means|125.07|||||TWO_SIDED|90.0|110.81|141.17||||||Natural log transformed AUCinf for PF-07817883 were analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect in Periods 1 to 4. The ratio (Test/Reference) and 90% CIs were expressed as percentages.||141.17|110.81|
72449086|NCT06122194|144416273|OTHER||Ratio of Adjusted Geometric Means|121.75|||||TWO_SIDED|90.0|108.65|136.43||||||Natural log transformed AUCinf for PF-07817883 were analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect in Periods 1 to 4. The ratio (Test/Reference) and 90% CIs were expressed as percentages.||136.43|108.65|
72449087|NCT02709161|144416290|SUPERIORITY||Mean Difference (Final Values)|8.2|||<|0.001|TWO_SIDED||||||ANOVA|||||||<0.001
72449088|NCT02709161|144416291|SUPERIORITY||Mean Difference (Final Values)|8.2|||<|0.001|TWO_SIDED||||||ANOVA|||||||<0.001
72449089|NCT04248725|144416322|SUPERIORITY||Mean Difference (Net)|-2.7||||0.004|TWO_SIDED||||||Mixed Models Analysis|Models were adjusted for sex, baseline severity, and disability condition.||||||0.004
72449090|NCT04248725|144416323|SUPERIORITY||Mean Difference (Net)|0.59|||<|0.001|TWO_SIDED|95.0|0.3|0.88|||Mixed Models Analysis|||||0.88|0.30|<0.001
72449091|NCT04248725|144416324|SUPERIORITY||Mean Difference (Net)|-0.32||||0.29|TWO_SIDED|95.0|-0.61|-0.03|||Mixed Models Analysis|||||-0.03|-0.61|0.29
72449092|NCT05622812|144416325|SUPERIORITY||Treatment difference|39.0|||<|0.001|TWO_SIDED|95.0|21.6|56.5||Two-sided p-value calculated using Fisher's Exact Test. The threshold of significance at \<0.05.|Fisher's Exact Test.||Difference confidence interval calculated using normal approximation.|||56.5|21.6|<0.001
72449093|NCT05622812|144416326|SUPERIORITY||Treatment difference|40.4|||<|0.001|TWO_SIDED|95.0|23.1|57.6||Two-sided p-value calculated using Fisher's Exact Test. The threshold of significance at \<0.05.|Fisher's Exact Test.||Difference confidence interval calculated using normal approximation.|Month 6||57.6|23.1|<0.001
72449094|NCT05622812|144416326|SUPERIORITY||Treatment difference|41.7|||<|0.001|TWO_SIDED|95.0|25.6|57.8||Two-sided p-value calculated using Fisher's Exact Test. The threshold of significance at \<0.05.|Fisher's Exact Test.||Difference confidence interval calculated using normal approximation.|Month 9||57.8|25.6|<0.001
72449095|NCT05622812|144416326|SUPERIORITY||Treatment difference|30.2||||0.003|TWO_SIDED|95.0|13.2|47.1||Two-sided p-value calculated using Fisher's Exact Test. The threshold of significance at \<0.05.|Fisher's Exact Test.||Difference confidence interval calculated using normal approximation.|Month 12||47.1|13.2|0.003
72449096|NCT05622812|144416327|SUPERIORITY||Treatment difference|99.0|||<|0.001|TWO_SIDED|95.0|97.1|100.0||Two-sided p-value calculated using Fisher's Exact Test. The threshold of significance at \<0.05.|Fisher's Exact Test.||Difference confidence interval calculated using normal approximation.|Month 3||100.0|97.1|<0.001
72449097|NCT05622812|144416327|SUPERIORITY||Treatment difference|87.6|||<|0.001|TWO_SIDED|95.0|76.9|98.2||Two-sided p-value calculated using Fisher's Exact Test. The threshold of significance at \<0.05.|Fisher's Exact Test.||Difference confidence interval calculated using normal approximation.|Month 6||98.2|76.9|<0.001
72449098|NCT05622812|144416327|SUPERIORITY||Treatment difference|80.5|||<|0.001|TWO_SIDED|95.0|68.6|92.4||Two-sided p-value calculated using Fisher's Exact Test. The threshold of significance at \<0.05.|Fisher's Exact Test.||Difference confidence interval calculated using normal approximation.|Month 9||92.4|68.6|<0.001
72449099|NCT05622812|144416327|SUPERIORITY||Treatment difference|73.7|||<|0.001|TWO_SIDED|95.0|61.9|85.5||Two-sided p-value calculated using Fisher's Exact Test. The threshold of significance at \<0.05.|Fisher's Exact Test.||Difference confidence interval calculated using normal approximation.|Month 12||85.5|61.9|<0.001
72449100|NCT05622812|144416328|SUPERIORITY||Treatment difference|93.1|||<|0.001|TWO_SIDED|95.0|88.2|98.0||Two-sided p-value calculated using Fisher's Exact Test. The threshold of significance at \<0.05.|Fisher's Exact Test.||Difference confidence interval calculated using normal approximation.|Month 3||98.0|88.2|<0.001
72449101|NCT05622812|144416328|SUPERIORITY||Treatment difference|87.9|||<|0.001|TWO_SIDED|95.0|81.4|94.3||Two-sided p-value calculated using Fisher's Exact Test. The threshold of significance at \<0.05.|Fisher's Exact Test.||Difference confidence interval calculated using normal approximation.|Month 6||94.3|81.4|<0.001
72449102|NCT05622812|144416328|SUPERIORITY||Treatment difference|80.4|||<|0.001|TWO_SIDED|95.0|72.7|88.1||Two-sided p-value calculated using Fisher's Exact Test. The threshold of significance at \<0.05.|Fisher's Exact Test.||Difference confidence interval calculated using normal approximation.|||88.1|72.7|<0.001
72498691|NCT03952559|144527775|SUPERIORITY||LS Mean difference (Final Values)|-3.89|STANDARD_ERROR_OF_MEAN|2.576||0.1317|TWO_SIDED|95.0|-8.95|1.17|||Mixed Models Analysis|||||1.17|-8.95|0.1317
72449103|NCT05622812|144416328|SUPERIORITY||Treatment difference|71.6|||<|0.001|TWO_SIDED|95.0|62.8|80.3||Two-sided p-value calculated using Fisher's Exact Test. The threshold of significance at \<0.05.|Fisher's Exact Test.||Difference confidence interval calculated using normal approximation.|Month 12||80.3|62.8|<0.001
72449104|NCT03916185|144416329|SUPERIORITY||Difference in proportions|0.0|||>|0.99|TWO_SIDED|95.0|-32.0|32.0||Statistical significance level of 0.05 was used. No adjustment for multiple comparisons.|Fisher Exact||Comparison was vaccine arm - placebo.|||32|-32|>0.99
72449105|NCT03916185|144416329|SUPERIORITY||Difference in proportions|-15.0||||0.53|TWO_SIDED|95.0|-46.0|18.0||Statistical significance level of 0.05 used. No adjustments made for multiple comparisons.|Fisher Exact||Comparison was vaccine arm - placebo.|||18|-46|0.53
72449106|NCT03916185|144416329|SUPERIORITY||Difference in proportions|16.0||||0.66|TWO_SIDED|95.0|-29.0|52.0||Statistical significance level of 0.05 was used. No adjustments made for multiple comparisons.|Fisher Exact||Comparison was vaccine arm - placebo.|||52|-29|0.66
72449107|NCT03916185|144416330|SUPERIORITY||Difference in proportions|0.0|||>|0.99|TWO_SIDED|95.0|-20.0|20.0||Statistical significance level of 0.05 was used. No adjustments made for multiple comparisons.|Fisher Exact||Comparison was vaccine arm - placebo.|||20|-20|>0.99
72449108|NCT03916185|144416330|SUPERIORITY||Difference in proportions|-5.0|||>|0.99|TWO_SIDED|95.0|-25.0|13.0||Statistical significance level of 0.05 was used. No adjustments made for multiple comparisons.|Fisher Exact||Comparison was vaccine arm - placebo.|||13|-25|>0.99
72449109|NCT03916185|144416330|SUPERIORITY||Difference in proportions|-5.0|||>|0.99|TWO_SIDED|95.0|-26.0|34.0||Statistical significance level of 0.05 was used. No adjustments made for multiple comparisons.|Fisher Exact||Comparison was vaccine arm - placebo.|||34|-26|>0.99
72498692|NCT03952559|144527775|SUPERIORITY||LS Mean difference (Final Values)|-5.15|STANDARD_ERROR_OF_MEAN|2.564||0.0451|TWO_SIDED|95.0|-10.19|-0.11|||Mixed Models Analysis|||||-0.11|-10.19|0.0451
72622400|NCT01272219|144774700|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.34|||<|0.0001|TWO_SIDED|95.0|3.54|5.32|||Regression, Logistic||The model included treatment, country, sex, pre-diabetes status at screening, BMI stratum and an interaction between pre-diabetes status at screening and BMI stratum as fixed factors, and the baseline value as covariate.|Null-hypothesis: no treatment difference between treatment arms, i.e. liraglutide 3.0 mg and liraglutide placebo. Liraglutide 3.0 mg was considered superior to placebo in inducing and maintaining weight loss as assessed by the proportion of subjects losing \>10% of their fasting baseline weight, if the estimated odds ratio (liraglutide 3.0 mg/liraglutide placebo) was statistically significantly greater than one.||5.32|3.54|<0.0001
72449110|NCT03916185|144416331|SUPERIORITY||Difference in proportions|0.0|||>|0.99|TWO_SIDED|95.0|-18.0|18.0||Statistical significance level of 0.05 was used. No adjustments made for multiple comparisons.|Fisher Exact||Comparison was vaccine arm - placebo.|||18|-18|>0.99
72449111|NCT03916185|144416331|SUPERIORITY||Difference in proportions|0.0|||>|0.99|TWO_SIDED|95.0|-18.0|18.0||Statistical significance level of 0.05 was used. No adjustments made for multiple comparisons.|Fisher Exact||Comparison was vaccine arm - placebo.|||18|-18|>0.99
72449112|NCT03916185|144416331|SUPERIORITY||Difference in proportions|0.0|||>|0.99|TWO_SIDED|95.0|-17.0|41.0||Statistical significance level of 0.05 was used. No adjustments made for multiple comparisons.|Fisher Exact||Comparison was vaccine arm - placebo.|||41|-17|>0.99
72449113|NCT03916185|144416332|SUPERIORITY||Difference in proportions|61.0|||<|0.001|TWO_SIDED|95.0|27.0|83.0||Statistical significance level of 0.05 was used. No adjustment for multiple comparisons.|Fisher Exact||Comparison was vaccine arm - placebo.|||83|27|<0.001
72449114|NCT03916185|144416332|SUPERIORITY||Difference in proportions|56.0|||<|0.001|TWO_SIDED|95.0|22.0|79.0|||Fisher Exact|Statistical significance level of 0.05 was used. No adjustments made for multiple comparisons.|Comparison was vaccine arm - placebo.|||79|22|<0.001
72449115|NCT03916185|144416332|SUPERIORITY||Difference in proportions|56.0||||0.011|TWO_SIDED|95.0|9.0|86.0|||Fisher Exact|Statistical significance level of 0.05 was used. No adjustments were made for multiple comparisons.|Comparison was vaccine arm - placebo.|||86|9|0.011
72449116|NCT03916185|144416332|SUPERIORITY||Difference in proportions|6.0|||>|0.99|TWO_SIDED|95.0|-25.0|36.0||Statistical significance level of 0.05 was used. No adjustments made for multiple comparisons.|Fisher Exact||Comparison was RSV ΔNS2/Δ1313/I1314L Vaccine - RSV 6120/ΔNS2/1030s Vaccine.|||36|-25|>0.99
72449117|NCT03916185|144416332|SUPERIORITY||Difference in proportions|5.0|||>|0.99|TWO_SIDED|95.0|-31.0|48.0||Statistical significance level of 0.05 was used. No adjustments made for multiple comparisons.|Fisher Exact||Comparison was RSV ΔNS2/Δ1313/I1314L Vaccine - RSV 276 Vaccine.|||48|-31|>0.99
72449118|NCT03916185|144416332|SUPERIORITY||Difference in proportions|-1.0|||>|0.99|TWO_SIDED|95.0|-38.0|44.0||Statistical significance level of 0.05 was used. No adjustments made for multiple comparisons.|Fisher Exact||Comparison was RSV 6120/ΔNS2/1030s Vaccine - RSV 276 Vaccine.|||44|-38|>0.99
72449119|NCT03916185|144416333|SUPERIORITY||Difference in proportions|73.0|||<|0.001|TWO_SIDED|95.0|44.0|91.0||Statistical significance level of 0.05 was used. No adjustments made for multiple comparisons.|Fisher Exact||Comparison was vaccine arm - placebo.|||91|44|<0.001
72449120|NCT03916185|144416333|SUPERIORITY||Difference in proportions|61.0|||<|0.001|TWO_SIDED|95.0|27.0|83.0||Statistical significance level of 0.05 was used. No adjustments made for multiple comparisons.|Fisher Exact||Comparison was vaccine arm - placebo.|||83|27|<0.001
72449121|NCT03916185|144416333|SUPERIORITY||Difference in proportions|85.0|||<|0.001|TWO_SIDED|95.0|42.0|97.0||Statistical significance level of 0.05 was used. No adjustments made for multiple comparisons.|Fisher Exact||Comparison was vaccine arm - placebo.|||97|42|<0.001
72449122|NCT03916185|144416333|SUPERIORITY||Difference in proportions|12.0||||0.66|TWO_SIDED|95.0|-17.0|40.0||Statistical significance level of 0.05 was used. No adjustments made for multiple comparisons.|Fisher Exact||Comparison was RSV ΔNS2/Δ1313/I1314L Vaccine - RSV 6120/ΔNS2/1030s Vaccine.|||40|-17|0.66
72449123|NCT03916185|144416333|SUPERIORITY||Difference in proportions|-12.0|||>|0.99|TWO_SIDED|95.0|-36.0|30.0||Statistical significance level of 0.05 was used. No adjustments made for multiple comparisons.|Fisher Exact||Comparison was RSV ΔNS2/Δ1313/I1314L Vaccine - RSV 276 Vaccine.|||30|-36|>0.99
72498693|NCT03952559|144527775|SUPERIORITY||LS Mean difference (Final Values)|-7.62|STANDARD_ERROR_OF_MEAN|2.566||0.0031|TWO_SIDED|95.0|-12.66|-2.58|||Mixed Models Analysis|||||-2.58|-12.66|0.0031
72498694|NCT03952559|144527776|SUPERIORITY||Odds Ratio (OR)|0.53||||0.4238|TWO_SIDED|95.0|0.11|2.49|||Regression, Logistic|||||2.49|0.11|0.4238
72498695|NCT03952559|144527776|SUPERIORITY||Odds Ratio (OR)|1.5||||0.5118|TWO_SIDED|95.0|0.44|5.08|||Regression, Logistic|||||5.08|0.44|0.5118
72561675|NCT01992094|144654053|NON_INFERIORITY_OR_EQUIVALENCE|The upper bound of the 2-sided 95% CI for the difference between seroconversion rates (% seroconversion TIV1c or TIV2c - %seroconversion QIVc) for HI antibody should not exceed the margin of 0 points.|Difference between seroconversion rates|-21.7|||||TWO_SIDED|95.0|-25.5|-17.7||||||Superiority of immune responses of QIVc to TIV2c in terms of seroconversion rates against influenza strain B1||-17.7|-25.5|
72561676|NCT01214239|144654056|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001||95.0|-0.71|-0.28|||ANCOVA|||||-0.28|-0.71|<0.0001
72449124|NCT03916185|144416333|SUPERIORITY||Difference in proportions|-24.0||||0.28|TWO_SIDED|95.0|-50.0|20.0||Statistical significance level of 0.05 was used. No adjustments made for multiple comparisons.|Fisher Exact||Comparison was RSV 6120/ΔNS2/1030s Vaccine - RSV 276 Vaccine.|||20|-50|0.28
72449125|NCT03916185|144416334|SUPERIORITY||||||<|0.001||||||Statistical significance level of 0.05 was used. No adjustments made for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||<0.001
72449126|NCT03916185|144416334|SUPERIORITY||||||<|0.001||||||Statistical significance level of 0.05 was used. No adjustments made for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||<0.001
72449127|NCT03916185|144416334|SUPERIORITY||||||<|0.001||||||Statistical significance of 0.05 was used. No adjustments made for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||<0.001
72498696|NCT03952559|144527776|SUPERIORITY||Odds Ratio (OR)|3.92||||0.0129|TWO_SIDED|95.0|1.34|11.52|||Regression, Logistic|||||11.52|1.34|0.0129
72498697|NCT03952559|144527777|SUPERIORITY||LS Mean difference (Final Values)|-1.51|STANDARD_ERROR_OF_MEAN|2.168||0.4852|TWO_SIDED|95.0|-5.77|2.75|||Mixed Models Analysis|||||2.75|-5.77|0.4852
72561677|NCT01214239|144654057|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.383|STANDARD_ERROR_OF_MEAN|0.074|<|0.0001||95.0|-0.527|-0.238|||ANCOVA|||||-0.238|-0.527|<0.0001
72370184|NCT03085797|144250813|OTHER||Difference in Medians|-2.68||||0.02|TWO_SIDED|95.0|-3.44|-1.91||p-Value was based on Wilcoxon rank-sum test and is adjusted for multiplicity.|Wilcoxon rank-sum test||Quantile regression with covariates: treatment, region, Baseline score, Baseline BEC. Par. with nasal surgery prior to Wks 49-52/withdrew early with no nasal surgery assigned their worst observed 4-wk mean prior to nasal surgery/study withdrawal.|||-1.91|-3.44|0.020
72449128|NCT03916185|144416334|SUPERIORITY|||||||0.95||||||Statistical significance level of 0.05 was used. No adjustments made for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.95
72449129|NCT03916185|144416334|SUPERIORITY|||||||0.12||||||Statistical significance level of 0.05 was used. No adjustments made for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.12
72449130|NCT03916185|144416334|SUPERIORITY|||||||0.033||||||Statistical significance level of 0.05 was used. No adjustments made for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.033
72449131|NCT03916185|144416335|SUPERIORITY||||||<|0.001||||||Statistical significance level of 0.05 was used. No adjustments made for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||<0.001
72449132|NCT03916185|144416335|SUPERIORITY||||||<|0.001||||||Statistical significance level of 0.05 was used. No adjustments made for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||<0.001
72449133|NCT03916185|144416335|SUPERIORITY||||||<|0.001||||||Statistical significance level of 0.05 was used. No adjustments made for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||<0.001
72449134|NCT03916185|144416335|SUPERIORITY|||||||0.39||||||Statistical significance level of 0.05 was used. No adjustments made for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.39
72449135|NCT03916185|144416335|SUPERIORITY|||||||0.15||||||Statistical significance level of 0.05 was used. No adjustments made for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.15
72498698|NCT03952559|144527777|SUPERIORITY||LS Mean difference (Final Values)|-1.74|STANDARD_ERROR_OF_MEAN|2.16||0.4205|TWO_SIDED|95.0|-5.98|2.5|||Mixed Models Analysis|||||2.50|-5.98|0.4205
72449136|NCT03916185|144416335|SUPERIORITY|||||||0.049||||||Statistical significance level of 0.05 was used. No adjustments made for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.049
72498699|NCT03952559|144527777|SUPERIORITY||LS Mean difference (Final Values)|-5.34|STANDARD_ERROR_OF_MEAN|2.161||0.0138|TWO_SIDED|95.0|-9.59|-1.1|||Mixed Models Analysis|||||-1.10|-9.59|0.0138
72498700|NCT03952559|144527778|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.000
72449137|NCT05312008|144416348|SUPERIORITY||||||<|0.6|||||||t-test, 2 sided|paired||||||<0.6
72449138|NCT05312008|144416349|SUPERIORITY||||||<|0.6|||||||t-test, 2 sided|Paired||||||<0.6
72449139|NCT05312008|144416350|SUPERIORITY||||||<|1|||||||t-test, 2 sided|Paired||||||<1
72449140|NCT05312008|144416351|SUPERIORITY||||||<|0.04|||||||t-test, 2 sided|Paired||||||<0.04
72449141|NCT05312008|144416352|SUPERIORITY||||||<|0.5|||||||t-test, 2 sided|Paired||||||<0.5
72449142|NCT02844465|144416357|NON_INFERIORITY|A non-inferiority test will be performed using a paired t-test, with a non-inferiority delta (δ) of one Reliable Change Index (RCI) of 5 points, to test the hypothesis of no reduction. A two-tailed alpha of 0.05 will be used.|||||<|0.0001|||||||Paired t-test|||"It is hypothesized that the Boston Naming Test score will not decrease from baseline to 12 months following the Visualase procedure. The hypotheses associated with this endpoint are as follows:~Null Hypothesis: μ (V-BNT - BSL-BNT) + δ ≤ 0 Alternate Hypothesis: μ (V-BNT - BSL-BNT) + δ \> 0 Where μ (V-BNT - BSL-BNT) = mean difference in the Boston Naming Test score from baseline to Month 12 post Visualase."||||<0.0001
72498701|NCT03952559|144527778|SUPERIORITY|||||||0.54|||||||Fisher Exact|||||||0.540
72498702|NCT03952559|144527778|SUPERIORITY|||||||0.302|||||||Fisher Exact|||||||0.302
72498703|NCT03952559|144527779|SUPERIORITY||LS Mean difference (Final Values)|4.47|STANDARD_ERROR_OF_MEAN|5.03||0.375|TWO_SIDED|95.0|-5.41|14.35|||ANOVA|||||14.35|-5.41|0.375
72498704|NCT03952559|144527779|SUPERIORITY||LS Mean difference (Final Values)|3.12|STANDARD_ERROR_OF_MEAN|5.03||0.536|TWO_SIDED|95.0|-6.76|13.0|||ANOVA|||||13.00|-6.76|0.536
72561678|NCT01214239|144654058|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001||95.0|-0.677|-0.323|||ANCOVA|||||-0.323|-0.677|<0.0001
72561679|NCT01214239|144654059|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.512|STANDARD_ERROR_OF_MEAN|0.098|<|0.0001||95.0|-0.705|-0.318|||ANCOVA|||||-0.318|-0.705|<0.0001
72561680|NCT01214239|144654060|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.46|STANDARD_ERROR_OF_MEAN|0.12||0.0001||95.0|-0.69|-0.23|||ANCOVA|||||-0.23|-0.69|0.0001
72561681|NCT01214239|144654061|SUPERIORITY_OR_OTHER||Adjusted mean difference|-11.2|STANDARD_ERROR_OF_MEAN|3.1||0.0003||95.0|-17.2|-5.2|||ANCOVA|||||-5.2|-17.2|0.0003
72561682|NCT01214239|144654062|SUPERIORITY_OR_OTHER||Adjusted mean difference|-8.8|STANDARD_ERROR_OF_MEAN|3.3||0.0086||95.0|-15.4|-2.3|||ANCOVA|||||-2.3|-15.4|0.0086
72449143|NCT02844465|144416358|NON_INFERIORITY|A non-inferiority test will be performed using a paired t-test, with a non-inferiority delta (δ) of one Reliable Change Index (RCI) of 15 points, to test the hypothesis of no reduction. A two-tailed alpha of 0.05 will be used.|||||<|0.0001|||||||Paired t-test|||"It is hypothesized that the Rey Auditory Verbal Learning Test 5-Trial Total score will not decrease from baseline to 12 months following the Visualase procedure. The hypotheses associated with this endpoint are as follows:~Null Hypothesis: μ (V-RAVLT - BSL-RAVLT) + δ ≤ 0 Alternate Hypothesis: μ (V-RAVLT - BSL-RAVLT) + δ \> 0 Where μ (V-RAVLT - BSL-RAVLT) = mean difference in the Rey Auditory Verbal Learning Test 5-Trial Total score from baseline to Month 12 post Visualase."||||<0.0001
72449144|NCT02844465|144416359|OTHER|A sign test will be used to determine if the median categorical change is significantly greater than zero.|||||<|0.0001|||||||Sign test|||"It is hypothesized that the QOLIE-31 score will increase (improve) from baseline to 12 months following the Visualase procedure. The hypotheses associated with this endpoint are as follows:~Null Hypothesis: M (V-QOLIE-31 - BSL-QOLIE-31) ≤ 0 Alternate Hypothesis: M (V-QOLIE-31 - BSL-QOLIE-31) \> 0 Where M (V-QOLIE-31 - BSL-QOLIE-31) = sign-test statistic (\[increases-decreases\]/2) in the Quality of Life in Epilepsy inventory from baseline to Month 12 post Visualase."||||<0.0001
72449145|NCT02844465|144416360|OTHER|A sign test will be used to determine if the median categorical change is significantly greater than zero.||||||0.0004|||||||Sign test|||"It is hypothesized that the SF-36 Mental Component Score (MCS) will increase (improve) from baseline to 12 months following the Visualase procedure. The hypotheses associated with this endpoint are as follows:~Null Hypothesis: M (V-SF-36 - BSL-SF-36-MCS) ≤ 0 Alternate Hypothesis: M (V-SF-36 - BSL-SF-36-MCS) \> 0 Where M (V- SF-36-MCS - BSL- SF-36-MCS) = sign-test statistic (\[increases-decreases\]/2) in the SF-36 quality of life questionnaire MCS from baseline to Month 12 post Visualase."||||0.0004
72449146|NCT02844465|144416361|OTHER|A sign test will be used to determine if the median categorical change is significantly greater than zero.|||||<|0.0001|||||||Sign test|||"It's hypothesized that the SF-36 Physical Component Score (PCS) will increase (improve) from baseline to 12 months following the Visualase procedure. The hypotheses associated with this endpoint are as follows:~Null Hypothesis: M (V-SF-36-PCS - BSL-SF-36-PCS) ≤ 0 Alternate Hypothesis: M (V-SF-36-PCS - BSL-SF-36-PCS) \> 0 Where M (V-SF-36-PCS - BSL- SF-36-PCS) = sign-test statistic (\[increases-decreases\]/2) in the SF-36 quality of life questionnaire PCS from baseline to Month 12 post Visualase."||||<0.0001
72449147|NCT02844465|144416362|NON_INFERIORITY|"The hypotheses associated with this endpoint are:~Null Hypothesis: π V - 64% + δ ≤ 0 Alternate Hypothesis: π V - 64% + δ \> 0 Where πV is the proportion of subjects treated with Visualase experiencing no seizures.~An exact 95% CI for the percentage of subjects who are seizure free will be calculated and its lower boundary compared to zero after subtraction of the historical open surgical resection percentage of 64% and the addition of the equivalence delta percentage of 10%."|Proportion of Participants|56.0|||||TWO_SIDED|95.0|46.2|65.8||||||||65.8|46.2|
72449148|NCT03819153|144416363|SUPERIORITY||Hazard Ratio (HR)|0.76||||0.0001|TWO_SIDED|95.0|0.66|0.88|||Regression, Cox|||Time from randomization to first composite renal event was analyzed using a Cox proportional hazards model with treatment as categorical fixed factor and stratified by use of sodium glucose cotransporter-2 (SGLT-2) inhibitor (yes/no) at baseline. Based on the available number of events for analysis, the nominal significance level was updated to 0.01612 using the Lan-DeMets alpha spending function. eGFR was calculated using the CKD-EPI formula.||0.88|0.66|0.0001
72498705|NCT03952559|144527779|SUPERIORITY||LS Mean difference (Final Values)|12.17|STANDARD_ERROR_OF_MEAN|5.03||0.016|TWO_SIDED|95.0|2.29|22.05|||ANOVA|||||22.05|2.29|0.016
72449149|NCT03738852|144416404|SUPERIORITY|||||||0.907|||||||ANOVA|||||||0.907
72449150|NCT03952338|144416441|SUPERIORITY||Mean Difference (Final Values)|-0.07||||0.97|TWO_SIDED|95.0|-4.07|3.93|||Mixed Models Analysis|||||3.93|-4.07|0.97
72449151|NCT03952338|144416442|SUPERIORITY||Mean Difference (Final Values)|1.22||||0.57|TWO_SIDED|95.0|-3.0|5.44|||Mixed Models Analysis|||||5.44|-3.00|0.57
72449152|NCT03952338|144416443|SUPERIORITY||Mean Difference (Final Values)|1.96||||0.09|TWO_SIDED|95.0|-0.32|4.23|||Mixed Models Analysis|||||4.23|-0.32|0.09
72449153|NCT03952338|144416444|SUPERIORITY||Mean Difference (Final Values)|2.1||||0.08|TWO_SIDED|95.0|-0.22|4.43|||Mixed Models Analysis|||||4.43|-0.22|0.08
72449154|NCT03952338|144416445|SUPERIORITY||Mean Difference (Final Values)|1.15||||0.09|TWO_SIDED|95.0|-0.17|2.46|||Mixed Models Analysis|||||2.46|-0.17|0.09
72449155|NCT03952338|144416446|SUPERIORITY||Mean Difference (Final Values)|-0.04||||0.95|TWO_SIDED|95.0|-1.39|1.3|||Mixed Models Analysis|||||1.30|-1.39|0.95
72449156|NCT03952338|144416447|SUPERIORITY||Odds Ratio (OR)|0.21||||0.01|TWO_SIDED|95.0|0.06|0.7|||Regression, Logistic|||||0.70|0.06|0.01
72449157|NCT03952338|144416448|SUPERIORITY||Odds Ratio (OR)|0.29||||0.04|TWO_SIDED|95.0|0.09|0.96|||Regression, Logistic|||||0.96|0.09|0.04
72449158|NCT03952338|144416449|SUPERIORITY||Odds Ratio (OR)|2.11||||0.236|TWO_SIDED|95.0|0.27|7.23|||Regression, Logistic|||||7.23|0.27|0.236
72449159|NCT03952338|144416450|SUPERIORITY||Odds Ratio (OR)|2.22||||0.22|TWO_SIDED|95.0|0.62|7.97|||Regression, Logistic|||||7.97|0.62|0.220
72498706|NCT03952559|144527780|SUPERIORITY||LS Mean difference (Final Values)|-49.19|STANDARD_ERROR_OF_MEAN|27.28||0.073|TWO_SIDED|95.0|-102.81|4.42|||ANOVA|||||4.42|-102.81|0.073
72498707|NCT03952559|144527780|SUPERIORITY||LS Mean difference (Final Values)|-37.38|STANDARD_ERROR_OF_MEAN|27.29||0.172|TWO_SIDED|95.0|-91.0|16.23|||ANOVA|||||16.23|-91.00|0.172
72498708|NCT03952559|144527780|SUPERIORITY||LS Mean difference (Final Values)|-80.37|STANDARD_ERROR_OF_MEAN|27.28||0.004|TWO_SIDED|95.0|-133.98|-26.75|||ANOVA|||||-26.75|-133.98|0.004
72498709|NCT03952559|144527781|SUPERIORITY||LS Mean difference (Final Values)|-0.65|STANDARD_ERROR_OF_MEAN|0.372||0.0829|TWO_SIDED|95.0|-1.38|0.08|||Mixed Models Analysis|||||0.08|-1.38|0.0829
72498710|NCT03952559|144527781|SUPERIORITY||LS Mean difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|0.368||0.1752|TWO_SIDED|95.0|-1.22|0.22|||Mixed Models Analysis|||||0.22|-1.22|0.1752
72498711|NCT03952559|144527781|SUPERIORITY||LS Mean difference (Final Values)|-1.1|STANDARD_ERROR_OF_MEAN|0.366||0.0029|TWO_SIDED|95.0|-1.82|-0.38|||Mixed Models Analysis|||||-0.38|-1.82|0.0029
72498712|NCT03952559|144527782|SUPERIORITY||LS Mean difference (Final Values)|-0.21|STANDARD_ERROR_OF_MEAN|0.193||0.2688|TWO_SIDED|95.0|-0.6|0.17|||Mixed Models Analysis|||||0.17|-0.60|0.2688
72498713|NCT03952559|144527782|SUPERIORITY||LS Mean difference (Final Values)|-0.47|STANDARD_ERROR_OF_MEAN|0.193||0.0166|TWO_SIDED|95.0|-0.85|-0.09|||Mixed Models Analysis|||||-0.09|-0.85|0.0166
72561683|NCT01214239|144654063|SUPERIORITY_OR_OTHER||Adjusted mean difference|-9.5|STANDARD_ERROR_OF_MEAN|3.8||0.0135||95.0|-17.0|-2.0|||ANCOVA|||||-2.0|-17.0|0.0135
72561684|NCT01214239|144654064|SUPERIORITY_OR_OTHER||Adjusted mean difference|-9.6|STANDARD_ERROR_OF_MEAN|3.8||0.0113||95.0|-17.1|-2.2|||ANCOVA|||||-2.2|-17.1|0.0113
72449160|NCT03952338|144416451|SUPERIORITY||Mean Difference (Final Values)|0.09||||0.7|TWO_SIDED|95.0|-0.37|0.55|||Mixed Models Analysis|||Total vegetables||0.55|-0.37|0.70
72449161|NCT03952338|144416451|SUPERIORITY||Median Difference (Final Values)|-0.07||||0.85|TWO_SIDED|95.0|-0.84|0.69|||Mixed Models Analysis|||Greens and beans||0.69|-0.84|0.85
72449162|NCT03952338|144416451|SUPERIORITY|Total fruits|Mean Difference (Final Values)|0.34||||0.29|TWO_SIDED|95.0|-0.29|0.98|||Mixed Models Analysis|||||0.98|-0.29|0.29
72449163|NCT03952338|144416451|SUPERIORITY||Median Difference (Final Values)|0.6||||0.07|TWO_SIDED|95.0|-0.06|1.26|||Mixed Models Analysis|||Whole fruits||1.26|-0.06|0.07
72449164|NCT03952338|144416451|SUPERIORITY||Mean Difference (Final Values)|-0.05||||0.92|TWO_SIDED|95.0|-1.16|1.05|||Mixed Models Analysis|||Whole grains||1.05|-1.16|0.92
72449165|NCT03952338|144416451|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.72|TWO_SIDED|95.0|-1.29|0.89|||Mixed Models Analysis|||Dairy||0.89|-1.29|0.72
72449166|NCT03952338|144416451|SUPERIORITY||Mean Difference (Final Values)|0.31||||0.15|TWO_SIDED|95.0|-0.12|0.74|||Mixed Models Analysis|||Total protein||0.74|-0.12|0.15
72449167|NCT03952338|144416451|SUPERIORITY||Mean Difference (Final Values)|-0.04||||0.92|TWO_SIDED|95.0|-0.78|0.71|||Mixed Models Analysis|||Seafood and plant proteins||0.71|-0.78|0.92
72449168|NCT03952338|144416451|SUPERIORITY||Mean Difference (Final Values)|-0.27||||0.67|TWO_SIDED|95.0|-1.47|0.94|||Mixed Models Analysis|||Fatty acids||0.94|-1.47|0.67
72449169|NCT03952338|144416451|SUPERIORITY||Mean Difference (Final Values)|-0.3||||0.61|TWO_SIDED|95.0|-1.45|0.84|||Mixed Models Analysis|||Sodium||0.84|-1.45|0.61
72449170|NCT03952338|144416451|SUPERIORITY||Mean Difference (Final Values)|-1.15||||0.06|TWO_SIDED|95.0|-2.34|0.04|||Mixed Models Analysis|||Refined grains||0.04|-2.34|0.06
72449171|NCT03952338|144416451|SUPERIORITY||Mean Difference (Final Values)|0.53||||0.32|TWO_SIDED|95.0|-0.51|1.57|||Mixed Models Analysis|||Saturated fats||1.57|-0.51|0.32
72449172|NCT03952338|144416451|SUPERIORITY||Mean Difference (Final Values)|0.18||||0.63|TWO_SIDED|95.0|-0.56|0.92|||Mixed Models Analysis|||Added sugars||0.92|-0.56|0.63
72449173|NCT03952338|144416452|SUPERIORITY||Mean Difference (Final Values)|-0.05||||0.85|TWO_SIDED|95.0|-0.61|0.5|||Mixed Models Analysis|||Total vegetables||0.50|-0.61|0.85
72449174|NCT03952338|144416452|SUPERIORITY||Mean Difference (Final Values)|-0.09||||0.82|TWO_SIDED|95.0|-0.88|0.7|||Mixed Models Analysis|||Greens and beans||0.70|-0.88|0.82
72561685|NCT01214239|144654066|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.552||||0.0021||95.0|1.407|4.629|||Regression, Logistic|The odds-ratio is based on a logistic regression model including baseline HbA1c and previous antidiabetic medication||Comparison by odds ratio for the patients with a baseline HbA1c \>= 7.0%||4.629|1.407|0.0021
72561686|NCT01214239|144654068|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.583||||0.25||95.0|0.724|3.46|||Regression, Logistic|||Comparison by odds ratio for the patients with a baseline HbA1c \>= 6.5%||3.46|0.724|0.2500
72561687|NCT01214239|144654069|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.527||||0.0005||95.0|1.494|4.276|||Regression, Logistic|The odds-ratio is based on a logistic regression model including baseline HbA1c and previous antidiabetic medication||||4.276|1.494|0.0005
72561688|NCT01049581|144654070|NON_INFERIORITY_OR_EQUIVALENCE|ANCOVA was used and the result reveled (F1, 17 = 7.565, η2= 0.308, p = 0.007)||||||0.007|ONE_SIDED|95.0|||||ANCOVA|||null hypothesis : there is no difference in gross motor performance in pediatric aquatic therapy group and conventional therapy group||||0.007
72561689|NCT01049581|144654071|NON_INFERIORITY_OR_EQUIVALENCE|ANCOVA : p value 0.393|Mean Difference (Net)|1.762||||0.393|ONE_SIDED|95.0||||"Effect Size η2~0.023"|ANCOVA|F1,17= 0.380||We hypothesize that Children with CP receiving PAT would have better outcomes in motor function and translate to ADL||||0.393
72449175|NCT03952338|144416452|SUPERIORITY||Mean Difference (Final Values)|0.25||||0.48|TWO_SIDED|95.0|-0.43|0.93|||Mixed Models Analysis|||Total fruits||0.93|-0.43|0.48
72449176|NCT03952338|144416452|SUPERIORITY||Mean Difference (Final Values)|0.71||||0.06|TWO_SIDED|95.0|-0.04|1.46|||Mixed Models Analysis|||Whole fruits||1.46|-0.04|0.06
72449177|NCT03952338|144416452|SUPERIORITY||Mean Difference (Final Values)|0.61||||0.34|TWO_SIDED|95.0|-0.63|1.84|||Mixed Models Analysis|||Whole grains||1.84|-0.63|0.34
72449178|NCT03952338|144416452|SUPERIORITY||Mean Difference (Final Values)|1.47||||0.01|TWO_SIDED|95.0|0.31|2.62|||Mixed Models Analysis|||Dairy||2.62|0.31|0.01
72449179|NCT03952338|144416452|SUPERIORITY||Median Difference (Final Values)|0.21||||0.39|TWO_SIDED|95.0|-0.27|0.69|||Mixed Models Analysis|||Total protein||0.69|-0.27|0.39
72449180|NCT03952338|144416452|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.81|TWO_SIDED|95.0|-0.9|0.7|||Mixed Models Analysis|||Seafood and plant proteins||0.70|-0.90|0.81
72449181|NCT03952338|144416452|SUPERIORITY||Mean Difference (Final Values)|-1.3||||0.04|TWO_SIDED|95.0|-2.57|-0.04|||Mixed Models Analysis|||Fatty acids||-0.04|-2.57|0.04
72449182|NCT03952338|144416452|SUPERIORITY||Mean Difference (Final Values)|-0.69||||0.25|TWO_SIDED|95.0|-1.86|0.48|||Mixed Models Analysis|||Sodium||0.48|-1.86|0.25
72449183|NCT03952338|144416452|SUPERIORITY||Mean Difference (Final Values)|0.08||||0.91|TWO_SIDED|95.0|-1.25|1.4|||Mixed Models Analysis|||Refined grains||1.40|-1.25|0.91
72449184|NCT03952338|144416452|SUPERIORITY||Mean Difference (Final Values)|0.07||||0.89|TWO_SIDED|95.0|-0.98|1.13|||Mixed Models Analysis|||Saturated fats||1.13|-0.98|0.89
72449185|NCT03952338|144416452|SUPERIORITY||Mean Difference (Final Values)|0.21||||0.59|TWO_SIDED|95.0|-0.55|0.97|||Mixed Models Analysis|||Added sugars||0.97|-0.55|0.59
72449186|NCT03952338|144416453|SUPERIORITY||Risk Ratio (RR)|0.15||||0.01|TWO_SIDED|95.0|0.03|0.67||Marginal food insecurity|Mixed Models Analysis|Mixed effects multinomial logistic regression||||0.67|0.03|0.01
72449187|NCT03952338|144416453|SUPERIORITY||Risk Ratio (RR)|0.56||||0.34|TWO_SIDED|95.0|0.17|1.82|||Mixed Models Analysis|Mixed effects multinomial logistic regression||Moderate food insecurity||1.82|0.17|0.34
72449188|NCT03952338|144416453|SUPERIORITY||Risk Ratio (RR)|0.16||||0.02|TWO_SIDED|95.0|0.03|0.76|||Mixed Models Analysis|Mixed effects multinomial logistic regression||Severe food insecurity||0.76|0.03|0.02
72498714|NCT03952559|144527782|SUPERIORITY||LS Mean difference (Final Values)|-0.34|STANDARD_ERROR_OF_MEAN|0.202||0.0908|TWO_SIDED|95.0|-0.75|0.06|||Mixed Models Analysis|||||0.06|-0.75|0.0908
72449189|NCT03952338|144416454|SUPERIORITY||Risk Ratio, log|0.28||||0.1|TWO_SIDED|95.0|0.06|1.29|||Mixed Models Analysis|Mixed effects multinomial logistic regression||Marginal food insecurity||1.29|0.06|0.10
72449190|NCT03952338|144416454|SUPERIORITY||Risk Ratio (RR)|0.68||||0.52|TWO_SIDED|95.0|0.21|2.21|||Mixed Models Analysis|Mixed effects multinomial logistic regression||Moderate food insecurity||2.21|0.21|0.52
72449191|NCT03952338|144416454|SUPERIORITY||Risk Ratio (RR)|0.11||||0.01|TWO_SIDED|95.0|0.02|0.56|||Mixed Models Analysis|Mixed effects multinomial logistic regression||Severe food insecurity||0.56|0.02|0.01
72449192|NCT03952338|144416455|SUPERIORITY||Risk Ratio (RR)|2.94||||0.15|TWO_SIDED|95.0|0.68|12.66|||Mixed Models Analysis|Mixed effects multinomial logistic regression||Medium malnutrition risk||12.66|0.68|0.15
72449193|NCT03952338|144416455|SUPERIORITY||Risk Ratio (RR)|1.18||||0.86|TWO_SIDED|95.0|0.2|7.13|||Mixed Models Analysis|Mixed effects multinomial logistic regression||High malnutrition risk||7.13|0.20|0.86
72449194|NCT03952338|144416456|SUPERIORITY||Risk Ratio (RR)|1.28||||0.74|TWO_SIDED|95.0|0.31|5.38|||Mixed Models Analysis|Mixed effects multinomial logistic regression||Medium malnutrition risk||5.38|0.31|0.74
72449195|NCT03952338|144416456|SUPERIORITY||Risk Ratio (RR)|5.48||||0.1|TWO_SIDED|95.0|0.73|41.3|||Mixed Models Analysis|Mixed effects multinomial logistic regression||High malnutrition risk||41.3|0.73|0.10
72449196|NCT03952338|144416457|SUPERIORITY||Mean Difference (Final Values)|-0.12||||0.64|TWO_SIDED|95.0|-0.65|0.4|||Mixed Models Analysis|||||0.40|-0.65|0.64
72561690|NCT01049581|144654072|SUPERIORITY_OR_OTHER|||||||0.332|ONE_SIDED|95.0|||||ANCOVA|||null hypothesis : there is no difference in social participation between pediatric aquatic therapy group and conventional therapy group||||0.332
72449197|NCT03952338|144416458|SUPERIORITY||Mean Difference (Final Values)|-0.03||||0.9|TWO_SIDED|95.0|-0.57|0.5|||Mixed Models Analysis|||||0.50|-0.57|0.90
72449198|NCT03952338|144416459|SUPERIORITY||Mean Difference (Final Values)|-4.07||||0.43|TWO_SIDED|95.0|-14.05|5.92||Males|Mixed Models Analysis|||||5.92|-14.05|0.43
72449199|NCT03952338|144416459|SUPERIORITY||Mean Difference (Final Values)|0.45||||0.83|TWO_SIDED|95.0|-3.75|4.66|||Mixed Models Analysis|||Females||4.66|-3.75|0.83
72449200|NCT03952338|144416460|SUPERIORITY||Mean Difference (Final Values)|-1.04||||0.66|TWO_SIDED|95.0|-5.65|3.57||Age 18-59 years|Mixed Models Analysis|||||3.57|-5.65|0.66
72449201|NCT03952338|144416460|SUPERIORITY||Mean Difference (Final Values)|3.28||||0.4|TWO_SIDED|95.0|-4.36|10.93|||Mixed Models Analysis|||Age 60+ years||10.93|-4.36|0.40
72449202|NCT03952338|144416461|SUPERIORITY||Mean Difference (Final Values)|6.25||||0.43|TWO_SIDED|95.0|-9.13|21.63|||Mixed Models Analysis|||Males||21.63|-9.13|0.43
72449203|NCT03952338|144416461|SUPERIORITY||Mean Difference (Final Values)|1.09||||0.62|TWO_SIDED|95.0|-3.23|5.41|||Mixed Models Analysis|||Females||5.41|-3.23|0.62
72449204|NCT03952338|144416462|SUPERIORITY||Mean Difference (Final Values)|-0.05||||0.99|TWO_SIDED|95.0|-4.76|4.66|||Mixed Models Analysis|||18-59 years||4.66|-4.76|0.99
72449205|NCT03952338|144416462|SUPERIORITY||Mean Difference (Final Values)|3.66||||0.43|TWO_SIDED|95.0|-5.48|12.8|||Mixed Models Analysis|||60+ years||12.80|-5.48|0.43
72449206|NCT02589795|144416486|OTHER|Inequality test|||||>|0.05|||||||Fisher Exact|||The proportions of subjects with primary safety outcomes were compared in a pairwise manner between the three randomised groups, using Fisher's exact tests.||||>0.05
72449207|NCT02589795|144416487|OTHER|Inequality test|||||>|0.05|||||||Kruskal-Wallis|Kruskal-Wallis test with Dunn's correction for multiple comparisons||Kruskal-Wallis test with Dunn's correction for multiple comparisons to compare the levels of antigen-specific serum IgG in the three groups at Week 22.||||>0.05
72449208|NCT01922050|144416513|SUPERIORITY||Rate ratio|0.53|||<|0.001|TWO_SIDED|95.0|0.4|0.69|||Negative binominal regression|Negative binominal regression with log baseline count as offset variable and treatment group and analysis site as factors.||||0.69|0.40|<0.001
72449209|NCT01922050|144416513|SUPERIORITY||Rate ratio|0.46|||<|0.001|TWO_SIDED|95.0|0.35|0.61|||Negative binominal regression|Negative binominal regression with log baseline count as offset variable and treatment group and analysis site as factors.||||0.61|0.35|<0.001
72449210|NCT01922050|144416513|SUPERIORITY||Rate ratio|0.36|||<|0.001|TWO_SIDED|95.0|0.28|0.48|||Negative binominal regression|Negative binominal regression with log baseline count as offset variable and treatment group and analysis site as factors.||||0.48|0.28|<0.001
72449211|NCT01922050|144416513|SUPERIORITY||Rate ratio|0.88||||0.38|TWO_SIDED|95.0|0.66|1.17|||Negative binominal regression|Negative binominal regression with log baseline count as offset variable and treatment group and analysis site as factors.||||1.17|0.66|0.38
72449212|NCT01922050|144416513|SUPERIORITY||Rate ratio|0.69||||0.013|TWO_SIDED|95.0|0.52|0.93|||Negative binominal regression|Negative binominal regression with log baseline count as offset variable and treatment group and analysis site as factors.||||0.93|0.52|0.013
72449213|NCT01922050|144416513|SUPERIORITY||Rate ratio|0.79||||0.13|TWO_SIDED|95.0|0.58|1.07|||Negative binominal regression|Negative binominal regression with log baseline count as offset variable and treatment group and analysis site as factors.||||1.07|0.58|0.13
72449214|NCT01922050|144416514|SUPERIORITY||Ratio of clearance rates|0.74||||0.57|TWO_SIDED|95.0|0.27|2.04|||Log binomial regression|||Log binomial regression with treatment group as factor and baseline AK count included as covariate.||2.04|0.27|0.57
72449215|NCT01922050|144416514|SUPERIORITY||Ratio of clearance rates|1.33||||0.51|TWO_SIDED|95.0|0.56|3.13|||Log binomial regression|||Log binomial regression with treatment group as factor and baseline AK count included as covariate.||3.13|0.56|0.51
72449216|NCT01922050|144416514|SUPERIORITY||Ratio of clearance rates|1.9||||0.11|TWO_SIDED|95.0|0.86|4.21|||Log binomial regression|||Log binomial regression with treatment group as factor and baseline AK count included as covariate.||4.21|0.86|0.11
72561691|NCT03203642|144654073|SUPERIORITY||LS mean difference|-0.0052|STANDARD_ERROR_OF_MEAN|0.0082||0.5265|TWO_SIDED|95.0|-0.0217|||Threshold for significance at 0.05 level.|ANCOVA|||An ANCOVA model included treatment group as a factor and the Baseline htTKV (log10 transformed) as a covariate for the analysis. The outcome measure was tested at 2-sided 0.05 level to control Type I error rate.||- 0.0112|-0.0217|0.5265
72449217|NCT01922050|144416514|SUPERIORITY||Ratio of clearance rates|1.79||||0.21|TWO_SIDED|95.0|0.72|4.43|||Log binomial regression|||Log binomial regression with treatment group as factor and baseline AK count included as covariate.||4.43|0.72|0.21
72449218|NCT01922050|144416514|SUPERIORITY||Ratio of clearance rates|2.55||||0.031|TWO_SIDED|95.0|1.09|5.98|||Log binomial regression|||Log binomial regression with treatment group as factor and baseline AK count included as covariate.||5.98|1.09|0.031
72449219|NCT01922050|144416514|SUPERIORITY||Ratio of clearance rates|1.43||||0.29|TWO_SIDED|95.0|0.74|2.75|||Log binomial regression|||Log binomial regression with treatment group as factor and baseline AK count included as covariate.||2.75|0.74|0.29
72449220|NCT01922050|144416515|SUPERIORITY||Ratio of clearance rates|1.69||||0.026|TWO_SIDED|95.0|1.06|2.69|||Log binomial regression|||Log binomial regression with treatment group as factor and baseline AK count included as covariate.||2.69|1.06|0.026
72449221|NCT01922050|144416515|SUPERIORITY||Ratio of clearance rates|1.79||||0.013|TWO_SIDED|95.0|1.13|2.84|||Log binomial regression|||Log binomial regression with treatment group as factor and baseline AK count included as covariate.||2.84|1.13|0.013
72449222|NCT01922050|144416515|SUPERIORITY||Ratio of clearance rates|2.1|||<|0.001|TWO_SIDED|95.0|1.35|3.25|||Log binomial regression|||||3.25|1.35|<0.001
72449223|NCT01922050|144416515|SUPERIORITY||Ratio of clearance rates|1.06||||0.73|TWO_SIDED|95.0|0.76|1.47|||Log binomial regression|||||1.47|0.76|0.73
72449224|NCT01922050|144416515|SUPERIORITY||Ratio of clearance rates|1.24||||0.16|TWO_SIDED|95.0|0.92|1.67|||Log binomial regression|||||1.67|0.92|0.16
72449225|NCT01922050|144416515|SUPERIORITY||Ratio of clearance rates|1.17||||0.3|TWO_SIDED|95.0|0.87|1.57|||Log binomial regression|||Log binomial regression with treatment group as factor and baseline AK count included as covariate.||1.57|0.87|0.30
72498715|NCT03952559|144527783|SUPERIORITY||LS Mean difference (Final Values)|-0.91|STANDARD_ERROR_OF_MEAN|0.956||0.3409|TWO_SIDED|95.0|-2.79|0.97|||Mixed Models Analysis|||||0.97|-2.79|0.3409
72449226|NCT02010242|144416529|SUPERIORITY|All statistical analyses were performed on a comparison-wise basis without adjustment for multiple comparisons.||||||1|||||||ANCOVA|||Primary efficacy endpoint was analyzed using ANCOVA comparing GKT137831 vs placebo after controlling for the baseline UACR level. The UACR were log-transformed prior to analysis. The model included treatment group and log-transformed baseline UACR value as predicted variables. The results were back-transformed exponentially to calculate geo. mean values and associated 90% CIs and 1-sided p-values. The null hypothesis was that the difference in the adjusted mean logarithm of UACR was equal to 0||||1.000
72449227|NCT05764525|144416546|SUPERIORITY||Difference of least squares mean|6.938||||0.0047|TWO_SIDED|95.0|2.145|11.731|||ANOVA|||||11.731|2.145|0.0047
72498716|NCT03952559|144527783|SUPERIORITY||LS Mean difference (Final Values)|-1.56|STANDARD_ERROR_OF_MEAN|0.952||0.1022|TWO_SIDED|95.0|-3.43|0.31|||Mixed Models Analysis|||||0.31|-3.43|0.1022
72449228|NCT03334630|144416549|NON_INFERIORITY|Assuming a Control composite SAE freedom rate of 93.5%, 226 subjects per group yields 80% power to detect a non-inferiority margin of -6.5% between treatment groups at a significance level of 0.025.|Risk Difference (RD)|0.0324|||<|0.0001|TWO_SIDED|95.0|-0.0132|0.0779||The a priori threshold for statistical significance is 0.025.|Farrington-Manning non-inferiority test||Estimated risk difference = DiamondTemp composite SAE freedom rate - Control composite SAE freedom rate = 3.24% = 0.0324|Null hypothesis: the DiamondTemp arm is inferior to the Control arm. Alternative hypothesis: the DiamondTemp arm is non-inferior to the Control arm.||0.0779|-0.0132|<0.0001
72449229|NCT03334630|144416550|NON_INFERIORITY|Assuming a Control primary effectiveness rate of 65%, 229 subjects per group yields 80% power to detect a non-inferiority margin of -12.5% between treatment groups at a significance level of 0.025.|Risk Difference (RD)|0.034|||<|0.0001|TWO_SIDED|95.0|-0.042|0.109||The a priori threshold for statistical significance is 0.025.|Farrington-Manning non-inferiority test||Estimated risk difference = DiamondTemp composite SAE freedom rate - Control composite SAE freedom rate = 3.4% = 0.034|Null hypothesis: the DiamondTemp arm is inferior to the Control arm. Alternative hypothesis: the DiamondTemp arm is non-inferior to the Control arm.||0.109|-0.042|<0.0001
72449230|NCT03334630|144416551|SUPERIORITY|"Four secondary endpoints will be tested for superiority over Control hierarchically with pre-specified order:~1. Mean duration of individual RF ablations (seconds)~2. Mean cumulative RF time per procedure (minutes)~3. Total fluoroscopy time (minutes)~4. Total procedure time (minutes) The first secondary endpoint needs to be significant at the two-sided 0.05 alpha level before the next one can be tested at the same threshold. Testing stops once an endpoint is determined to be non-significant."|Mean Difference (Final Values)|-17.9|||<|0.0001|TWO_SIDED|95.0|-21.2|-14.6||The a priori threshold for statistical significance is 0.05 two-sided. The p-value is adjusted for multiple comparisons via the hierarchical testing approach.|t-test, 2 sided||Difference is DiamondTemp minus Control. A lower value is better.|"Null hypothesis: the population means for the DiamondTemp and Control groups are not different.~Alternative hypothesis: the population means for the DiamondTemp and Control groups are different."||-14.6|-21.2|<0.0001
72498717|NCT03952559|144527783|SUPERIORITY||LS Mean difference (Final Values)|-1.56|STANDARD_ERROR_OF_MEAN|0.953||0.1024|TWO_SIDED|95.0|-3.43|0.31|||Mixed Models Analysis|||||0.31|-3.43|0.1024
72498718|NCT03952559|144527784|SUPERIORITY||LS Mean difference (Final Values)|-0.23|STANDARD_ERROR_OF_MEAN|0.157||0.1436|TWO_SIDED|95.0|-0.54|0.08|||Mixed Models Analysis|||||0.08|-0.54|0.1436
72498719|NCT03952559|144527784|SUPERIORITY||LS Mean difference (Final Values)|-0.31|STANDARD_ERROR_OF_MEAN|0.154||0.0483|TWO_SIDED|95.0|-0.61|0.0|||Mixed Models Analysis|||||-0.00|-0.61|0.0483
72498720|NCT03952559|144527784|SUPERIORITY||LS Mean difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|0.154||0.0012|TWO_SIDED|95.0|-0.8|-0.2|||Mixed Models Analysis|||||-0.20|-0.80|0.0012
72498721|NCT03952559|144527785|SUPERIORITY||LS Mean difference (Final Values)|0.18|STANDARD_ERROR_OF_MEAN|1.755||0.9183|TWO_SIDED|95.0|-3.27|3.63|||Mixed Models Analysis|||for 8 to \<18 years old||3.63|-3.27|0.9183
72498722|NCT03952559|144527785|SUPERIORITY||LS Mean difference (Final Values)|-1.08|STANDARD_ERROR_OF_MEAN|1.529||0.4805|TWO_SIDED|95.0|-4.09|1.93|||Mixed Models Analysis|||for 8 to \<18 years old||1.93|-4.09|0.4805
72498723|NCT03952559|144527785|SUPERIORITY||LS Mean difference (Final Values)|-1.7|STANDARD_ERROR_OF_MEAN|1.812||0.3488|TWO_SIDED|95.0|-5.26|1.86|||Mixed Models Analysis|||for 8 to \<18 years old||1.86|-5.26|0.3488
72498724|NCT03952559|144527785|SUPERIORITY||LS Mean difference (Final Values)|1.4|STANDARD_ERROR_OF_MEAN|3.12||0.2388|TWO_SIDED|95.0|-4.85|7.66|||Mixed Models Analysis|||for 5 to \<8 years old||7.66|-4.85|0.2388
72449231|NCT03334630|144416552|SUPERIORITY|"Four secondary endpoints will be tested for superiority over Control hierarchically with pre-specified order:~1. Mean duration of individual RF ablations (seconds)~2. Mean cumulative RF time per procedure (minutes)~3. Total fluoroscopy time (minutes)~4. Total procedure time (minutes) The first secondary endpoint needs to be significant at the two-sided 0.05 alpha level before the next one can be tested at the same threshold. Testing stops once an endpoint is determined to be non-significant."|Mean Difference (Final Values)|-11.9|||<|0.0001|TWO_SIDED|95.0|-13.9|-9.8||The a priori threshold for statistical significance is 0.05 two-sided. The p-value is adjusted for multiple comparisons via the hierarchical testing approach.|t-test, 2 sided||Difference is DiamondTemp minus Control. A lower value is better.|"Null hypothesis: the population means for the DiamondTemp and Control groups are not different.~Alternative hypothesis: the population means for the DiamondTemp and Control groups are different."||-9.8|-13.9|<0.0001
72449232|NCT03334630|144416561|SUPERIORITY|"Four secondary endpoints will be tested for superiority over Control hierarchically with pre-specified order:~1. Mean duration of individual RF ablations (seconds)~2. Mean cumulative RF time per procedure (minutes)~3. Total fluoroscopy time (minutes)~4. Total procedure time (minutes) The first secondary endpoint needs to be significant at the two-sided 0.05 alpha level before the next one can be tested at the same threshold. Testing stops once an endpoint is determined to be non-significant."|Mean Difference (Final Values)|-5.7|||||TWO_SIDED|95.0|-14.4|3.1||The a priori threshold for statistical significance is 0.05 two-sided. The p-value is adjusted for multiple comparisons via the hierarchical testing approach.||Since the previous secondary endpoint (Total fluoroscopy time) was non-significant, testing stopped and this secondary endpoint was not tested.|Difference is DiamondTemp minus Control. A lower value is better.|"Null hypothesis: the population means for the DiamondTemp and Control groups are not different.~Alternative hypothesis: the population means for the DiamondTemp and Control groups are different."||3.1|-14.4|
72469796|NCT01575873|144463473|SUPERIORITY||LS Mean Difference|2.5|||<|0.001|TWO_SIDED|95.0|1.7|3.2||2-sided p-value corresponding to the 2-sided 95% confidence interval|ANCOVA||LS Mean Difference = Denosumab - Risedronate|"Analyses of the primary and secondary endpoints were performed independently within each subpopulation using a fixed-sequence testing procedure to control the experiment-wise type 1 error rate at a two-sided 5% significance level.~The glucocorticoid-continuing subpopulation was analyzed using an ANCOVA model adjusted for treatment, baseline BMD, sex, machine type, baseline BMD-by-machine type interaction, and duration of prior glucocorticoid use (\< 12 months vs ≥ 12 months)."||3.2|1.7|< 0.001
72498725|NCT03952559|144527785|SUPERIORITY||LS Mean difference (Final Values)|-3.13|STANDARD_ERROR_OF_MEAN|3.542||0.0098|TWO_SIDED|95.0|-10.23|3.98|||Mixed Models Analysis|||for 5 to \<8 years old||3.98|-10.23|0.0098
72498726|NCT03952559|144527785|SUPERIORITY||LS Mean difference (Final Values)|1.12|STANDARD_ERROR_OF_MEAN|3.14||0.1698|TWO_SIDED|95.0|-5.18|7.42|||Mixed Models Analysis|||for 5 to \<8 years old||7.42|-5.18|0.1698
72498727|NCT03952559|144527786|SUPERIORITY||LS Mean difference (Final Values)|0.32|STANDARD_ERROR_OF_MEAN|1.813||0.8611|TWO_SIDED|95.0|-3.24|3.88|||Mixed Models Analysis|||for 8 to \<18 years old||3.88|-3.24|0.8611
72498728|NCT03952559|144527786|SUPERIORITY||LS Mean difference (Final Values)|-1.04|STANDARD_ERROR_OF_MEAN|1.571||0.5098|TWO_SIDED|95.0|-4.12|2.05|||Mixed Models Analysis|||for 8 to \<18 years old||2.05|-4.12|0.5098
72498729|NCT03952559|144527786|SUPERIORITY||LS Mean difference (Final Values)|-2.4|STANDARD_ERROR_OF_MEAN|1.87||0.1997|TWO_SIDED|95.0|-6.08|1.27|||Mixed Models Analysis|||for 8 to \<18 years old||1.27|-6.08|0.1997
72498730|NCT03952559|144527786|SUPERIORITY||LS Mean difference (Final Values)|1.62|STANDARD_ERROR_OF_MEAN|3.351||0.1957|TWO_SIDED|95.0|-5.11|8.35|||Mixed Models Analysis|||for 5 to \<8 years old||8.35|-5.11|0.1957
72498731|NCT03952559|144527786|SUPERIORITY||LS Mean difference (Final Values)|-0.44|STANDARD_ERROR_OF_MEAN|3.864||0.0881|TWO_SIDED|95.0|-8.19|7.32|||Mixed Models Analysis|||for 5 to \<8 years old||7.32|-8.19|0.0881
72498732|NCT03952559|144527786|SUPERIORITY||LS Mean difference (Final Values)|1.51|STANDARD_ERROR_OF_MEAN|3.379||0.1604|TWO_SIDED|95.0|-5.27|8.28|||Mixed Models Analysis|||for 5 to \<8 years old||8.28|-5.27|0.1604
72498733|NCT03952559|144527787|SUPERIORITY||LS Mean difference (Final Values)|-0.67|STANDARD_ERROR_OF_MEAN|0.647||0.2987|TWO_SIDED|95.0|-1.93|0.59|||Mixed Models Analysis|||||0.59|-1.93|0.2987
72498734|NCT03952559|144527787|SUPERIORITY||LS Mean difference (Final Values)|-0.64|STANDARD_ERROR_OF_MEAN|0.632||0.3096|TWO_SIDED|95.0|-1.88|0.6|||Mixed Models Analysis|||||0.60|-1.88|0.3096
72498735|NCT03952559|144527787|SUPERIORITY||LS Mean difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.635||0.6341|TWO_SIDED|95.0|-1.55|0.95|||Mixed Models Analysis|||||0.95|-1.55|0.6341
72498736|NCT03952559|144527788|SUPERIORITY||LS Mean difference (Final Values)|5.27|STANDARD_ERROR_OF_MEAN|4.323||0.2871|TWO_SIDED|95.0|-6.54|17.09|||Mixed Models Analysis|||||17.09|-6.54|0.2871
72498737|NCT03952559|144527788|SUPERIORITY||LS Mean difference (Final Values)|4.73|STANDARD_ERROR_OF_MEAN|3.835||0.3093|TWO_SIDED|95.0|-7.83|17.29|||Mixed Models Analysis|||||17.29|-7.83|0.3093
72498738|NCT03952559|144527788|SUPERIORITY||LS Mean difference (Final Values)|-5.0|STANDARD_ERROR_OF_MEAN|3.788||0.2912|TWO_SIDED|95.0|-18.22|8.21|||Mixed Models Analysis|||||8.21|-18.22|0.2912
72498739|NCT03952559|144527789|SUPERIORITY|Absenteeism Change from Baseline|LS Mean difference (Final Values)|-1.6|STANDARD_ERROR_OF_MEAN|3.119||0.6079|TWO_SIDED|95.0|-7.74|4.54|||Mixed Models Analysis|||||4.54|-7.74|0.6079
72498740|NCT03952559|144527789|SUPERIORITY||LS Mean difference (Final Values)|-1.85|STANDARD_ERROR_OF_MEAN|3.092||0.5492|TWO_SIDED|95.0|-7.94|4.24|||Mixed Models Analysis|||Absenteeism Change from Baseline||4.24|-7.94|0.5492
72498741|NCT03952559|144527789|SUPERIORITY||LS Mean difference (Final Values)|-4.93|STANDARD_ERROR_OF_MEAN|3.281||0.1338|TWO_SIDED|95.0|-11.39|1.53|||Mixed Models Analysis|||Absenteeism Change from Baseline||1.53|-11.39|0.1338
72498742|NCT03952559|144527789|SUPERIORITY||LS Mean difference (Final Values)|-0.94|STANDARD_ERROR_OF_MEAN|3.566||0.7928|TWO_SIDED|95.0|-7.96|6.08|||Mixed Models Analysis|||Presenteeism Change from Baseline||6.08|-7.96|0.7928
72498743|NCT03952559|144527789|SUPERIORITY||LS Mean difference (Final Values)|-5.3|STANDARD_ERROR_OF_MEAN|3.553||0.1366|TWO_SIDED|95.0|-12.3|1.69|||Mixed Models Analysis|||Presenteeism Change from Baseline||1.69|-12.30|0.1366
72498744|NCT03952559|144527789|SUPERIORITY||LS Mean difference (Final Values)|-6.75|STANDARD_ERROR_OF_MEAN|3.792||0.076|TWO_SIDED|95.0|-14.21|0.71|||Mixed Models Analysis|||Presenteeism Change from Baseline||0.71|-14.21|0.0760
72498745|NCT03952559|144527789|SUPERIORITY||LS Mean difference (Final Values)|-4.18|STANDARD_ERROR_OF_MEAN|4.561||0.3602|TWO_SIDED|95.0|-13.16|4.8|||Mixed Models Analysis|||Overall Work Impairment Change from Baseline||4.80|-13.16|0.3602
72449233|NCT03334630|144416566|SUPERIORITY|"Four secondary endpoints will be tested for superiority over Control hierarchically with pre-specified order:~1. Mean duration of individual RF ablations (seconds)~2. Mean cumulative RF time per procedure (minutes)~3. Total fluoroscopy time (minutes)~4. Total procedure time (minutes) The first secondary endpoint needs to be significant at the two-sided 0.05 alpha level before the next one can be tested at the same threshold. Testing stops once an endpoint is determined to be non-significant."|Mean Difference (Final Values)|-0.2||||0.8528|TWO_SIDED|95.0|-1.9|1.6||The a priori threshold for statistical significance is 0.05 two-sided. The p-value is adjusted for multiple comparisons via the hierarchical testing approach.|t-test, 2 sided||Difference is DiamondTemp minus Control. A lower value is better.|"Null hypothesis: the population means for the DiamondTemp and Control groups are not different.~Alternative hypothesis: the population means for the DiamondTemp and Control groups are different."||1.6|-1.9|0.8528
72449234|NCT03910478|144416611|EQUIVALENCE|A two-sided Wald-test for evidence of a non-zero coefficient for intervention group in the regression was conducted at the 5% significance level.|Odds Ratio (OR)|0.948||||0.892|TWO_SIDED|95.0|0.438|2.053|||Regression, Logistic|The logistic regression was adjusted by covariates (transplant site and participant's perceived ease of access to blood draw facility).||A traditional logistic regression model was fit where the outcome was whether or not participants completed \> 90% of their clinician-recommended CMV monitoring tests in the study period by 1-year after HCT.||2.053|0.438|0.8920
72449235|NCT03910478|144416612|EQUIVALENCE|A two-sided Wald-test for evidence of a non-zero coefficient for intervention group in the regression was conducted at the 5% significance level.|Odds Ratio (OR)|0.66||||0.3008|TWO_SIDED|95.0|0.301|1.45|||Regression, Logistic|The logistic regression was adjusted by covariates (transplant site and participant's perceived ease of access to blood draw facility).||A traditional logistic regression model was fit where the outcome was whether or not participants completed \> 90% of their clinician -recommended CMV monitoring tests in the study period by 1-year after HCT.||1.450|0.301|0.3008
72449236|NCT06415292|144416643|SUPERIORITY||||||<|0.001||||||The P-value reported here is the calculated p-value. The p-value theshold for significance was p =0.05|t-test, 2 sided|||||||<0.001
72449237|NCT01712490|144416645|SUPERIORITY||Hazard Ratio (HR)|0.77||||0.035|TWO_SIDED|95.0|0.603|0.983|||Log Rank|||Hazard ratio (A+AVD/ABVD) and 95% confidence interval (CI) are based on a stratified Cox's proportional hazard regression model with stratification factors region and number of International Prognostic Factor Project (IPFP) risk factors at baseline with treatment as the explanatory variable in the model. Hazard ratio less than (\<) 1 favors A+AVD arm.||0.983|0.603|0.035
72449238|NCT01712490|144416646|SUPERIORITY||Hazard Ratio (HR)|0.728||||0.199|TWO_SIDED|95.0|0.448|1.184|||Log Rank|||Hazard ratio (A+AVD/ABVD) and 95% CI are based on a stratified Cox's proportional hazard regression model with stratification factors region and number of IPFP risk factors at baseline with treatment as the explanatory variable in the model. Hazard ratio \<1 favors A+AVD arm.||1.184|0.448|0.199
72449239|NCT03987022|144416670|SUPERIORITY|||||||0.16|||||||Wilcoxon (Mann-Whitney)|||||||.16
72449240|NCT03987022|144416671|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||||||1.00
72449241|NCT03987022|144416672|SUPERIORITY|||||||0.01|||||||Wilcoxon (Mann-Whitney)|||||||.01
72449242|NCT03987022|144416673|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||||||1.00
72449243|NCT03987022|144416674|SUPERIORITY|||||||0.58|||||||Wilcoxon (Mann-Whitney)|||||||.58
72449244|NCT03987022|144416675|SUPERIORITY|||||||0.47|||||||Wilcoxon (Mann-Whitney)|||||||.47
72449245|NCT03987022|144416676|SUPERIORITY|||||||0.4|||||||Wilcoxon (Mann-Whitney)|||||||0.4
72449246|NCT03987022|144416677|SUPERIORITY|||||||0.02|||||||Wilcoxon (Mann-Whitney)|||||||.02
72449247|NCT03987022|144416678|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
72449248|NCT04800211|144416697|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Test 1 is equal to zero on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Test 1 is NOT equal to zero on Visit 5 (Week 6). (mITT Population)|Mean Difference (Net)|-178.789|||<|0.0001|TWO_SIDED|95.0|-204.899|-152.678|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Test 1 is equal to zero on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Test 1 is NOT equal to zero on Visit 5 (Week 6). (mITT Population)||-152.678|-204.899|<.0001
72449249|NCT04800211|144416697|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Test 1 is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Test 1 is NOT equal to zero on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|-184.391|||<|0.0001|TWO_SIDED|95.0|-211.184|-157.598|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Test 1 is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Test 1 is NOT equal to zero on Visit 7 (Week 12). (mITT Population)||-157.598|-211.184|<.0001
72469797|NCT00965497|144463474|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|95.0||||0.01|TWO_SIDED|95.0|||||t-test, 2 sided|||There were 13 people that completed so there truly was no power to detect true differences; therefore only trends can be discussed.||||0.01
72469798|NCT01299480|144463491|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Binomial Distribution|||PMB80 \[A22\]: Response rate was compared with 50%, using 1-sided exact test based on binomial distribution. p-Value \<0.0125 was considered significant.||||<0.001
72469799|NCT01299480|144463491|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Binomial Distribution|||PMB2001 \[A56\]: Response rate was compared with 50%, using 1-sided exact test based on binomial distribution. p-Value \<0.0125 was considered significant.||||<0.001
72469800|NCT01299480|144463491|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Binomial Distribution|||PMB2948 \[B24\]: Response rate was compared with 50%, using 1-sided exact test based on binomial distribution. p-Value \<0.0125 was considered significant.||||<0.001
72449250|NCT04800211|144416697|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Test 2 is equal to zero on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Test 2 is NOT equal to zero on Visit 5 (Week 6). (mITT Population)|Mean Difference (Net)|-175.1|||<|0.0001|TWO_SIDED|95.0|-200.964|-149.237|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Test 2 is equal to zero on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Test 2 is NOT equal to zero on Visit 5 (Week 6). (mITT Population)||-149.237|-200.964|<.0001
72449251|NCT04800211|144416697|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Test 2 is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Test 2 is NOT equal to zero on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|-161.576|||<|0.0001|TWO_SIDED|95.0|-187.543|-135.609|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Test 2 is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Test 2 is NOT equal to zero on Visit 7 (Week 12). (mITT Population)||-135.609|-187.543|<.0001
72449252|NCT04800211|144416697|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Test 1 + Test 2 is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Test 1 + Test 2 is NOT equal to zero on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|-172.983|||<|0.0001|TWO_SIDED|95.0|-192.08|-153.886|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Test 1 + Test 2 is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Test 1 + Test 2 is NOT equal to zero on Visit 7 (Week 12). (mITT Population)||-153.886|-192.080|<.0001
72449253|NCT04800211|144416697|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Control is equal to zero on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Control is NOT equal to zero on Visit 5 (Week 6). (mITT Population)|Mean Difference (Net)|-3.585||||0.7781|TWO_SIDED|95.0|-28.572|21.401|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Control is equal to zero on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Control is NOT equal to zero on Visit 5 (Week 6). (mITT Population)||21.401|-28.572|0.7781
72449254|NCT04800211|144416697|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Control is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Control is NOT equal to zero on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|-7.764||||0.5457|TWO_SIDED|95.0|-32.993|17.465|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Control is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Control is NOT equal to zero on Visit 7 (Week 12). (mITT Population)||17.465|-32.993|0.5457
72498746|NCT03952559|144527789|SUPERIORITY||LS Mean difference (Final Values)|-6.25|STANDARD_ERROR_OF_MEAN|4.516||0.1678|TWO_SIDED|95.0|-15.14|2.65|||Mixed Models Analysis|||Overall Work Impairment Change from Baseline||2.65|-15.14|0.1678
72498747|NCT03952559|144527789|SUPERIORITY||LS Mean difference (Final Values)|-11.54|STANDARD_ERROR_OF_MEAN|4.808||0.017|TWO_SIDED|95.0|-21.0|-2.08|||Mixed Models Analysis|||Overall Work Impairment Change from Baseline||-2.08|-21.00|0.0170
72498748|NCT03952559|144527789|SUPERIORITY||LS Mean difference (Final Values)|-4.42|STANDARD_ERROR_OF_MEAN|3.174||0.1645|TWO_SIDED|95.0|-10.66|1.82|||Mixed Models Analysis|||Activity Impairment Change from Baseline||1.82|-10.66|0.1645
72561692|NCT03203642|144654074|SUPERIORITY||LS mean difference|-0.0042|STANDARD_ERROR_OF_MEAN|0.0111||0.7076|TWO_SIDED|95.0|-0.0264|||Threshold for significance at 0.05 level.|ANCOVA|||An ANCOVA model included treatment group as a factor and the Baseline htTKV (log10 transformed) as a covariate for the analysis. The outcome measure was tested at 2-sided 0.05 level to control Type I error rate.||- 0.0180|-0.0264|0.7076
72622401|NCT01272219|144774701|SUPERIORITY_OR_OTHER||Treatment estimate|2.681|||<|0.0001|TWO_SIDED|95.0|1.856|3.872|||Weibull analysis||The treatment estimate was the factor that the time to event is multiplied with for liraglutide 3.0 mg compared to placebo.|If the estimated time-to-event ratio (liraglutide 3.0 mg/ placebo), as assessed by the survival endpoint describing the time until onset of T2DM ('diabetes-free time'), is statistically significantly \>1, then liraglutide 3.0 mg was to be considered superior to placebo in delaying the onset of T2DM in subjects with pre-diabetes at baseline. Weibull model was used; included treatment, sex and BMI stratification factor as fixed factors and baseline FPG as a covariate.||3.872|1.856|<.0001
72498749|NCT03952559|144527789|SUPERIORITY||LS Mean difference (Final Values)|-4.87|STANDARD_ERROR_OF_MEAN|3.158||0.124|TWO_SIDED|95.0|-11.07|1.34|||Mixed Models Analysis|||Activity Impairment Change from Baseline||1.34|-11.07|0.1240
72561693|NCT03203642|144654075|SUPERIORITY||LS mean difference|-0.0122|STANDARD_ERROR_OF_MEAN|0.014||0.3895|TWO_SIDED|95.0|-0.0404|||Threshold for significance at 0.05 level.|ANCOVA|||An ANCOVA model included treatment group as a factor and the Baseline htTKV (log10 transformed) as a covariate for the analysis. The outcome measure was tested at 2-sided 0.05 level to control Type I error rate.||- 0.0160|-0.0404|0.3895
72449255|NCT04800211|144416697|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Test 1 is equal to Control on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Test 1 is NOT equal to Control on Visit 5 (Week 6). (mITT Population)|Mean Difference (Net)|-175.203|||<|0.0001|TWO_SIDED|95.0|-220.445|-129.961|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Test 1 is equal to Control on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Test 1 is NOT equal to Control on Visit 5 (Week 6). (mITT Population)||-129.961|-220.445|<.0001
72449256|NCT04800211|144416697|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Test 1 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Test 1 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|-176.627|||<|0.0001|TWO_SIDED|95.0|-222.672|-130.582|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Test 1 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Test 1 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)||-130.582|-222.672|<.0001
72449257|NCT04800211|144416697|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Test 2 is equal to Control on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Test 2 is NOT equal to Control on Visit 5 (Week 6). (mITT Population)|Mean Difference (Net)|-171.515|||<|0.0001|TWO_SIDED|95.0|-216.626|-126.404|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Test 2 is equal to Control on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Test 2 is NOT equal to Control on Visit 5 (Week 6). (mITT Population)||-126.404|-216.626|<.0001
72449258|NCT04800211|144416697|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|-153.812|||<|0.0001|TWO_SIDED|95.0|-199.27|-108.354|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)||-108.354|-199.270|<.0001
72449259|NCT04800211|144416697|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Test 1 + Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Test 1 + Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|-165.22|||<|0.0001|TWO_SIDED|95.0|-195.898|-134.541|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Test 1 + Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Test 1 + Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)||-134.541|-195.898|<.0001
72449260|NCT04800211|144416697|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Test 1 is equal to Test 2 on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Test 1 is NOT equal to Test 2 on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|-22.815||||0.2188|TWO_SIDED|95.0|-59.223|13.593|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Test 1 is equal to Test 2 on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Test 1 is NOT equal to Test 2 on Visit 7 (Week 12). (mITT Population)||13.593|-59.223|0.2188
72469801|NCT01299480|144463491|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Binomial Distribution|||PMB2707 \[B44\]: Response rate was compared with 50%, using 1-sided exact test based on binomial distribution. p-Value \<0.0125 was considered significant.||||<0.001
72469802|NCT01299480|144463491|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Binomial Distribution|||PMB80 \[A22\]: Response rate was compared with 50%, using 1-sided exact test based on binomial distribution. p-Value \<0.0125 was considered significant.||||<0.001
72469803|NCT01299480|144463491|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Binomial Distribution|||PMB2001 \[A56\]: Response rate was compared with 50%, using 1-sided exact test based on binomial distribution. p-Value \<0.0125 was considered significant.||||<0.001
72469804|NCT01299480|144463491|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Binomial Distribution|||PMB2948 \[B24\]: Response rate was compared with 50%, using 1-sided exact test based on binomial distribution. p-Value \<0.0125 was considered significant.||||<0.001
72370185|NCT03085797|144250814|OTHER||Difference in Medians|-0.37||||0.02|TWO_SIDED|95.0|-0.65|-0.08||p-Value was based on Wilcoxon rank-sum test and is adjusted for multiplicity.|Wilcoxon rank-sum test||Quantile regression with covariates: treatment, region, Baseline score, Baseline BEC. Par. with nasal surgery prior to Wks 49-52/withdrew early with no nasal surgery assigned their worst observed 4-wk mean prior to nasal surgery/study withdrawal.|||-0.08|-0.65|0.020
72561694|NCT03203642|144654076|SUPERIORITY||LS mean difference|0.0015|STANDARD_ERROR_OF_MEAN|0.0131||0.9093|TWO_SIDED|95.0|-0.0248|||Threshold for significance at 0.05 level.|ANCOVA|||An ANCOVA model included treatment group as a factor and the Baseline htTKV (log10 transformed) as a covariate for the analysis. The outcome measure was tested at 2-sided 0.05 level to control Type I error rate.||- 0.0278|-0.0248|0.9093
72561695|NCT02367872|144654079|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|51.08|||||TWO_SIDED|95.0|35.22|74.08||||||TAK-272F: Least square mean (LS) mean cohort ratios for the test groups (Cohort 2R) and the reference group (Cohort 1R) with their 95 percent (%) confidence intervals (CI) were calculated using an analysis of variance (ANOVA) model for natural log-transformed data.||74.08|35.22|
72561696|NCT02367872|144654079|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|117.95|||||TWO_SIDED|95.0|81.32|171.07||||||TAK-272F: LS mean cohort ratios for the test groups (Cohort 3R) and the reference group (Cohort 1R) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.||171.07|81.32|
72561697|NCT02367872|144654079|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|272.87|||||TWO_SIDED|95.0|188.14|395.76||||||TAK-272F: LS mean cohort ratios for the test groups (Cohort 4R) and the reference group (Cohort 1R) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.||395.76|188.14|
72561698|NCT02367872|144654079|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|183.27|||||TWO_SIDED|95.0|126.36|265.81||||||TAK-272F: LS mean cohort ratios for the test groups (Cohort 5R-Part 2) and the reference group (Cohort 1R) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.||265.81|126.36|
72561699|NCT02367872|144654079|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|101.67|||||TWO_SIDED|95.0|68.95|149.9||||||TAK-272F: LS mean cohort ratios for the test groups (Cohort 2H) and the reference group (Cohort 1H) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.||149.90|68.95|
72561700|NCT02367872|144654079|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|135.98|||||TWO_SIDED|95.0|92.23|200.5||||||TAK-272F: LS mean cohort ratios for the test groups (Cohort 3H) and the reference group (Cohort 1H) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.||200.50|92.23|
72619543|NCT03537729|144769952|SUPERIORITY|Power was based on planned 12 sites and effect size Cohen's d=0.42 for pairwise differences between arms, intraclass correlation coefficient of 0.0012, and reduction in variance due to adjustment for baseline and repeated measures with correlation of 0.4 between pairs of measures. The sample size requirement was 38 per group, or 114 total for power of .80 in two-sided tests at .05 level of significance.|Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.18||0.96|TWO_SIDED|95.0|-0.35|0.37||P-value was not adjusted for multiple comparisons. A priori threshold for statistical significance was .05.|Mixed Models Analysis|Covariates included baseline value of the outcome, age, sex, and cognition score at baseline, and use of wheelchair on the route.|Spaced retrieval minus control.|The null hypothesis was that means of two arms on the low complexity route are equal, the alternative was that means were not equal.||0.37|-0.35|.96
72619544|NCT03537729|144769952|SUPERIORITY|Power was based on planned 12 sites and effect size Cohen's d=0.42 for pairwise differences between arms, intraclass correlation coefficient of 0.0012, and reduction in variance due to adjustment for baseline and repeated measures with correlation of 0.4 between pairs of measures. The sample size requirement was 38 per group, or 114 total for power of .80 in two-sided tests at .05 level of significance.|Mean Difference (Final Values)|-0.54|STANDARD_ERROR_OF_MEAN|0.18|<|0.01|TWO_SIDED|95.0|-0.89|-0.18||P-value was not adjusted for multiple comparisons. A priori threshold for statistical significance was .05.|Mixed Models Analysis|Covariates included baseline value of the outcome, age, sex, and cognition score at baseline, and use of wheelchair on the route.|Spaced retrieval minus cues only|The null hypothesis was that means of two arms on the low complexity route are equal, the alternative was that means were not equal.||-0.18|-0.89|<.01
72498750|NCT03952559|144527789|SUPERIORITY||LS Mean difference (Final Values)|-7.02|STANDARD_ERROR_OF_MEAN|3.163||0.027|TWO_SIDED|95.0|-13.23|-0.8|||Mixed Models Analysis|||Activity Impairment Change from Baseline||-0.80|-13.23|0.0270
72498751|NCT03952559|144527790|SUPERIORITY||LS Mean difference (Final Values)|1.97|STANDARD_ERROR_OF_MEAN|2.778||0.4778|TWO_SIDED|95.0|-3.49|7.43|||Mixed Models Analysis|||||7.43|-3.49|0.4778
72561701|NCT02367872|144654079|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|62.34|||||TWO_SIDED|95.0|36.17|107.45||||||M-I: LS mean cohort ratios for the test groups (Cohort 2R) and the reference group (Cohort 1R) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.||107.45|36.17|
72561702|NCT02367872|144654079|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|93.2|||||TWO_SIDED|95.0|54.08|160.64||||||M-I: LS mean cohort ratios for the test groups (Cohort 3R) and the reference group (Cohort 1R) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.||160.64|54.08|
72561703|NCT02367872|144654079|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|274.21|||||TWO_SIDED|95.0|159.1|472.63||||||M-I: LS mean cohort ratios for the test groups (Cohort 4R) and the reference group (Cohort 1R) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.||472.63|159.10|
72561704|NCT02367872|144654079|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|261.12|||||TWO_SIDED|95.0|151.5|450.05||||||M-I: LS mean cohort ratios for the test groups (Cohort 5R-Part 2) and the reference group (Cohort 1R) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.||450.05|151.50|
72561705|NCT02367872|144654079|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|112.47|||||TWO_SIDED|95.0|69.34|182.41||||||M-I: LS mean cohort ratios for the test groups (Cohort 2H) and the reference group (Cohort 1H) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.||182.41|69.34|
72561706|NCT02367872|144654079|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|176.75|||||TWO_SIDED|95.0|108.97|286.67||||||M-I: LS mean cohort ratios for the test groups (Cohort 3H) and the reference group (Cohort 1H) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.||286.67|108.97|
72561707|NCT02367872|144654080|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|57.36|||||TWO_SIDED|95.0|37.76|87.14||||||TAK-272F: LS mean cohort ratios for the test groups (Cohort 2R) and the reference group (Cohort 1R) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.||87.14|37.76|
72561708|NCT02367872|144654080|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|77.04|||||TWO_SIDED|95.0|50.72|117.03||||||TAK-272F: LS mean cohort ratios for the test groups (Cohort 3R) and the reference group (Cohort 1R) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.||117.03|50.72|
72449261|NCT04800211|144416698|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine Total NNAL (ng/g creatinine) in Test 1 is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g creatinine) in Test 1 is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-248.311|||<|0.0001|TWO_SIDED|95.0|-286.423|-210.199|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine Total NNAL (ng/g creatinine) in Test 1 is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g creatinine) in Test 1 is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||-210.199|-286.423|<.0001
72449262|NCT04800211|144416698|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine Total NNAL (ng/g creatinine) in Test 1 is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g creatinine) in Test 1 is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-247.572|||<|0.0001|TWO_SIDED|95.0|-280.904|-214.241|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine Total NNAL (ng/g creatinine) in Test 1 is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g creatinine) in Test 1 is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||-214.241|-280.904|<.0001
72449263|NCT04800211|144416698|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine Total NNAL (ng/g creatinine) in Test 1 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g creatinine) in Test 1 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-245.868|||<|0.0001|TWO_SIDED|95.0|-284.945|-206.791|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine Total NNAL (ng/g creatinine) in Test 1 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g creatinine) in Test 1 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||-206.791|-284.945|<.0001
72449264|NCT04800211|144416698|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine Total NNAL (ng/g creatinine) in Test 2 is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g creatinine) in Test 2 is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-234.942|||<|0.0001|TWO_SIDED|95.0|-271.603|-198.282|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine Total NNAL (ng/g creatinine) in Test 2 is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g creatinine) in Test 2 is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||-198.282|-271.603|<.0001
72469805|NCT01299480|144463491|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Binomial Distribution|||PMB2707 \[B44\]: Response rate was compared with 50%, using 1-sided exact test based on binomial distribution. p-Value \<0.0125 was considered significant.||||<0.001
72469806|NCT01299480|144463493|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Binomial Distribution|||PMB80 \[A22\]: Response rate was compared with 50%, using 1-sided exact test based on binomial distribution. p-Value \<0.0125 was considered significant.||||<0.001
72469807|NCT01299480|144463493|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Binomial Distribution|||PMB2001 \[A56\]: Response rate was compared with 50%, using 1-sided exact test based on binomial distribution. p-Value \<0.0125 was considered significant.||||<0.001
72469808|NCT01299480|144463493|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Binomial Distribution|||PMB2948 \[B24\]: Response rate was compared with 50%, using 1-sided exact test based on binomial distribution. p-Value \<0.0125 was considered significant.||||<0.001
72469809|NCT01299480|144463493|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Binomial Distribution|||PMB2707 \[B44\]: Response rate was compared with 50%, using 1-sided exact test based on binomial distribution. p-Value \<0.0125 was considered significant.||||<0.001
72370186|NCT01837823|144250818|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|-0.231||||0.054|TWO_SIDED||||||Regression, Linear|||||||0.054
72370187|NCT01837823|144250819|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|0.074||||0.5|TWO_SIDED||||||Pearson correlation coefficient|||for minimum lumen area site||||0.50
72469810|NCT02296892|144463502|SUPERIORITY||Difference in Rates|0.7588|||<|0.0001|TWO_SIDED|95.0|0.6903|0.8274|||Cochran-Mantel-Haenszel|||||0.8274|0.6903|<0.0001
72469811|NCT02165826|144463510|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.66||||0.017|TWO_SIDED|95.0|0.47|0.93||Study treatment, country and baseline forced expiratory volume in the first second (FEV1) as explanatory variables.|Regression, Logistic|||Analyses were performed using a hierarchical testing procedure.||0.93|0.47|0.017
72469812|NCT02165826|144463510|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.68|||||TWO_SIDED|95.0|0.51|0.92|||||Cox proportional hazards model with study treatment and country as class effects, and baseline FEV1 as a continuous variable.|Analyses were performed using a hierarchical testing procedure.||0.92|0.51|
72449265|NCT04800211|144416698|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine Total NNAL (ng/g creatinine) in Test 2 is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g creatinine) in Test 2 is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-244.049|||<|0.0001|TWO_SIDED|95.0|-275.269|-212.829|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine Total NNAL (ng/g creatinine) in Test 2 is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g creatinine) in Test 2 is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||-212.829|-275.269|<.0001
72449266|NCT04800211|144416698|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine Total NNAL (ng/g creatinine) in Test2 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g creatinine) in Test2 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-221.385|||<|0.0001|TWO_SIDED|95.0|-258.371|-184.398|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine Total NNAL (ng/g creatinine) in Test2 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g creatinine) in Test2 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||-184.398|-258.371|<.0001
72498752|NCT03952559|144527790|SUPERIORITY||LS Mean difference (Final Values)|2.01|STANDARD_ERROR_OF_MEAN|2.743||0.4649|TWO_SIDED|95.0|-3.38|7.39|||Mixed Models Analysis|||||7.39|-3.38|0.4649
72498753|NCT03952559|144527790|SUPERIORITY||LS Mean difference (Final Values)|4.52|STANDARD_ERROR_OF_MEAN|2.755||0.1013|TWO_SIDED|95.0|-0.89|9.94|||Mixed Models Analysis|||||9.94|-0.89|0.1013
72498754|NCT03952559|144527791|SUPERIORITY||LS Mean difference (Final Values)|0.08|STANDARD_ERROR_OF_MEAN|0.174||0.6574|TWO_SIDED|95.0|-0.27|0.42|||Mixed Models Analysis|||||0.42|-0.27|0.6574
72498755|NCT03952559|144527791|SUPERIORITY||LS Mean difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.172||0.9488|TWO_SIDED|95.0|-0.35|0.33|||Mixed Models Analysis|||||0.33|-0.35|0.9488
72498756|NCT03952559|144527791|SUPERIORITY||LS Mean difference (Final Values)|-0.13|STANDARD_ERROR_OF_MEAN|0.172||0.4546|TWO_SIDED|95.0|-0.47|0.21|||Mixed Models Analysis|||||0.21|-0.47|0.4546
72498757|NCT03952559|144527792|SUPERIORITY||LS Mean difference (Final Values)|-0.09|STANDARD_ERROR_OF_MEAN|0.36||0.8133|TWO_SIDED|95.0|-0.79|0.62|||Mixed Models Analysis|||||0.62|-0.79|0.8133
72498758|NCT03952559|144527792|SUPERIORITY||LS Mean difference (Final Values)|-0.41|STANDARD_ERROR_OF_MEAN|0.355||0.2517|TWO_SIDED|95.0|-1.11|0.29|||Mixed Models Analysis|||||0.29|-1.11|0.2517
72498759|NCT03952559|144527792|SUPERIORITY||LS Mean difference (Final Values)|-0.62|STANDARD_ERROR_OF_MEAN|0.354||0.0803|TWO_SIDED|95.0|-1.32|0.08|||Mixed Models Analysis|||||0.08|-1.32|0.0803
72498760|NCT01870739|144527800|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.0616||||0.7324|TWO_SIDED|95.0|-0.4178|0.2947|||Linear Model|Treatment as fixed effect and corresponding baseline as covariate.||||0.2947|-0.4178|0.7324
72498761|NCT01870739|144527801|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.0371||||0.8614|TWO_SIDED|95.0|-0.4582|0.3839|||Linear Model|Treatment as a fixed effect and corresponding baseline as a covariate||||0.3839|-0.4582|0.8614
72498762|NCT01870739|144527802|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.0812||||0.7946|TWO_SIDED|95.0|-0.6987|0.5362|||Linear Model|Treatment as a fixed effect and corresponding baseline as a covariate||||0.5362|-0.6987|0.7946
72561709|NCT02367872|144654080|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|206.41|||||TWO_SIDED|95.0|135.88|313.54||||||TAK-272F: LS mean cohort ratios for the test groups (Cohort 4R) and the reference group (Cohort 1R) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.||313.54|135.88|
72498763|NCT01986062|144527810|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.0001
72498764|NCT01986062|144527811|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.0001
72498765|NCT01986062|144527812|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.0001
72498766|NCT01986062|144527813|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.0001
72498767|NCT01986062|144527814|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.0001
72498768|NCT01986062|144527815|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.0001
72498769|NCT00630331|144527827|SUPERIORITY_OR_OTHER_LEGACY||Vaccine Efficacy|83.8|||<|0.001|ONE_SIDED|97.5|61.0|||Adjusted p-values are from score statistic with Sidak correction testing the null hypothesis that the VE of CCI vs. placebo is \<= 40% (the relative risk, \>= 0.60). If adjusted p-value is \<0.025, then the comparison is statistically significant.|Sidak-corrected score CI|||"Vaccine efficacy (VE) of CCI vaccine vs. Placebo (Overall)~Simultaneous one-sided 97.5% confidence interval (CI) for the VE of CCI vaccine relative to Placebo was based on the Sidak-corrected score CIs for the two relative risks."|||61.0|<0.001
72561710|NCT02367872|144654080|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|143.11|||||TWO_SIDED|95.0|94.21|217.39||||||TAK-272F: LS mean cohort ratios for the test groups (Cohort 5R-Part 2) and the reference group (Cohort 1R) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.||217.39|94.21|
72498770|NCT00630331|144527827|SUPERIORITY_OR_OTHER_LEGACY||Vaccine Efficacy|88.2|||<|0.001|ONE_SIDED|97.5|67.4|||Adjusted p-values are from score statistic with Sidak correction testing the null hypothesis that the VE of CCI vs. placebo is \<= 40% (the relative risk, \>= 0.60). If adjusted p-value is \<0.025, then the comparison is statistically significant.|Sidak-corrected score CI|||"Vaccine efficacy (VE) of CCI vaccine vs. Placebo for A/H1N1 strain~Simultaneous one-sided 97.5% confidence interval (CI) for the VE of CCI vaccine relative to Placebo was based on the Sidak-corrected score CIs for the two relative risks."|||67.4|<0.001
72449267|NCT04800211|144416698|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine Total NNAL (ng/g creatinine) in Test 1 + Test 2 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g creatinine) in Test 1 + Test 2 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-233.626|||<|0.0001|TWO_SIDED|95.0|-261.113|-206.14|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine Total NNAL (ng/g creatinine) in Test 1 + Test 2 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g creatinine) in Test 1 + Test 2 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||-206.140|-261.113|<.0001
72449268|NCT04800211|144416698|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine Total NNAL (ng/g creatinine) in Control is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g creatinine) in Control is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|26.266||||0.1672|TWO_SIDED|95.0|-11.13|63.661|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine Total NNAL (ng/g creatinine) in Control is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g creatinine) in Control is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||63.661|-11.130|0.1672
72449269|NCT04800211|144416698|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine Total NNAL (ng/g creatinine) in Control is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g creatinine) in Control is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-40.051||||0.014|TWO_SIDED|95.0|-71.881|-8.221|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine Total NNAL (ng/g creatinine) in Control is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g creatinine) in Control is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||-8.221|-71.881|0.0140
72449270|NCT04800211|144416698|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine Total NNAL (ng/g creatinine) in Control is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g creatinine) in Control is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-42.635||||0.0288|TWO_SIDED|95.0|-80.785|-4.484|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine Total NNAL (ng/g creatinine) in Control is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g creatinine) in Control is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||-4.484|-80.785|0.0288
72449271|NCT04800211|144416698|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine Total NNAL (ng/g creatinine) in Test 1 is equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g creatinine) in Test 1 is NOT equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-274.577|||<|0.0001|TWO_SIDED|95.0|-345.428|-203.726|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine Total NNAL (ng/g creatinine) in Test 1 is equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g creatinine) in Test 1 is NOT equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||-203.726|-345.428|<.0001
72449272|NCT04800211|144416698|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine Total NNAL (ng/g creatinine) in Test 1 is equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g creatinine) in Test 1 is NOT equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-207.521|||<|0.0001|TWO_SIDED|95.0|-269.198|-145.844|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine Total NNAL (ng/g creatinine) in Test 1 is equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g creatinine) in Test 1 is NOT equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||-145.844|-269.198|<.0001
72449273|NCT04800211|144416698|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine Total NNAL (ng/g creatinine) in Test 1 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g creatinine) in Test 1 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-203.233|||<|0.0001|TWO_SIDED|95.0|-275.683|-130.784|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine Total NNAL (ng/g creatinine) in Test 1 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g creatinine) in Test 1 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||-130.784|-275.683|<.0001
72561711|NCT02367872|144654080|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|85.31|||||TWO_SIDED|95.0|51.03|142.61||||||TAK-272F: LS mean cohort ratios for the test groups (Cohort 2H) and the reference group (Cohort 1H) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.||142.61|51.03|
72561712|NCT02367872|144654080|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|131.63|||||TWO_SIDED|95.0|78.74|220.04||||||TAK-272F: LS mean cohort ratios for the test groups (Cohort 3H) and the reference group (Cohort 1H) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.||220.04|78.74|
72370188|NCT02914301|144250831|OTHER|We compared outcomes between study arms using t-tests for continuous outcomes.|||||<|0.001|||||||t-test, 2 sided|||||||<0.001
72449274|NCT04800211|144416698|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine Total NNAL (ng/g creatinine) in Test 2 is equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g creatinine) in Test 2 is NOT equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-261.208|||<|0.0001|TWO_SIDED|95.0|-330.647|-191.769|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine Total NNAL (ng/g creatinine) in Test 2 is equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g creatinine) in Test 2 is NOT equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||-191.769|-330.647|<.0001
72449275|NCT04800211|144416698|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine Total NNAL (ng/g creatinine) in Test 2 is equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g creatinine) in Test 2 is NOT equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-203.998|||<|0.0001|TWO_SIDED|95.0|-263.396|-144.599|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine Total NNAL (ng/g creatinine) in Test 2 is equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g creatinine) in Test 2 is NOT equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||-144.599|-263.396|<.0001
72449276|NCT04800211|144416698|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine Total NNAL (ng/g creatinine) in Test 2 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g creatinine) in Test 2 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-178.75|||<|0.0001|TWO_SIDED|95.0|-249.092|-108.408|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine Total NNAL (ng/g creatinine) in Test 2 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g creatinine) in Test 2 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||-108.408|-249.092|<.0001
72469813|NCT02165826|144463510|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.76||||0.114|TWO_SIDED|95.0|0.55|1.07||Study treatment, country and baseline forced expiratory volume in the first second (FEV1) as explanatory variables.|Regression, Logistic|||Analyses were performed using a hierarchical testing procedure.||1.07|0.55|0.114
72561713|NCT02367872|144654080|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|70.38|||||TWO_SIDED|95.0|40.42|122.53||||||M-I: LS mean cohort ratios for the test groups (Cohort 2R) and the reference group (Cohort 1R) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.||122.53|40.42|
72561714|NCT02367872|144654080|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|55.03|||||TWO_SIDED|95.0|31.61|95.81||||||M-I: LS mean cohort ratios for the test groups (Cohort 3R) and the reference group (Cohort 1R) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.||95.81|31.61|
72561715|NCT02367872|144654080|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|125.96|||||TWO_SIDED|95.0|72.35|219.3||||||M-I: LS mean cohort ratios for the test groups (Cohort 4R) and the reference group (Cohort 1R) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.||219.30|72.35|
72370189|NCT04248491|144250871|SUPERIORITY|||||||0.342|||||||t-test, 2 sided|||||||0.342
72370190|NCT04248491|144250872|SUPERIORITY|||||||0.035|||||||t-test, 2 sided|||||||0.035
72370191|NCT04248491|144250874|SUPERIORITY|||||||0.098|||||||t-test, 2 sided|||||||0.098
72449277|NCT04800211|144416698|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine Total NNAL (ng/g creatinine) in Test 1 + Test 2 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g creatinine) in Test 1 + Test 2 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-190.992|||<|0.0001|TWO_SIDED|95.0|-237.134|-144.85|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine Total NNAL (ng/g creatinine) in Test 1 + Test 2 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g creatinine) in Test 1 + Test 2 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||-144.850|-237.134|<.0001
72449278|NCT04800211|144416698|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine Total NNAL (ng/g creatinine) in Test 2 is equal to Test 1 on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g creatinine) in Test 2 is NOT equal to Test 1 on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-24.483||||0.359|TWO_SIDED|95.0|-77.096|28.13|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine Total NNAL (ng/g creatinine) in Test 2 is equal to Test 1 on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g creatinine) in Test 2 is NOT equal to Test 1 on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||28.130|-77.096|0.3590
72449279|NCT04800211|144416699|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 is equal to zero on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 is NOT equal to zero on Visit 5 (Week 6). (mITT Population)|Mean Difference (Net)|-2.287|||<|0.0001|TWO_SIDED|95.0|-2.582|-1.992|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 is equal to zero on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 is NOT equal to zero on Visit 5 (Week 6). (mITT Population)||-1.992|-2.582|<.0001
72469814|NCT02165826|144463510|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.77|||||TWO_SIDED|95.0|0.58|1.02|||||Cox proportional hazards model with study treatment and country as class effects, and baseline FEV1 as a continuous variable.|Analyses were performed using a hierarchical testing procedure.||1.02|0.58|
72469815|NCT02165826|144463511|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.63||||0.001|TWO_SIDED|95.0|0.47|0.83||Study treatment, country and baseline forced expiratory volume in the first second (FEV1) as explanatory variables.|Regression, Logistic|||Analyses were performed using a hierarchical testing procedure.||0.83|0.47|0.001
72469816|NCT02165826|144463511|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.78||||0.091|TWO_SIDED|95.0|0.59|1.04||Study treatment, country and baseline forced expiratory volume in the first second (FEV1) as explanatory variables.|Regression, Logistic|||Analyses were performed using a hierarchical testing procedure.||1.04|0.59|0.091
72498771|NCT00630331|144527827|SUPERIORITY_OR_OTHER_LEGACY|||||||0.999||97.5||||Adjusted p-values are from score statistic with Sidak correction testing the null hypothesis that the VE of CCI vs. placebo is \<= 40% (the relative risk, \>= 0.60). If adjusted p-value is \<0.025, then the comparison is statistically significant.|Sidak-corrected score CI|For strain A/H3N2, the vaccine efficacy of the CCI vaccine vs. placebo was not evaluable since no influenza case was observed in the placebo group.||Vaccine efficacy (VE) of CCI vaccine vs. Placebo for A/H3N2 strain. Simultaneous one-sided 97.5% confidence interval (CI) for the VE of CCI vaccine relative to Placebo was based on the Sidak-corrected score CIs for the two relative risks.||||0.999
72498772|NCT00630331|144527827|SUPERIORITY_OR_OTHER_LEGACY||Vaccine Efficacy|100.0||||0.394|ONE_SIDED|97.5|-410.0|||Adjusted p-values are from score statistic with Sidak correction testing the null hypothesis that the VE of CCI vs. placebo is \<= 40% (the relative risk, \>= 0.60). If adjusted p-value is \<0.025, then the comparison is statistically significant.|Sidak-corrected score CI|||"Vaccine efficacy (VE) of CCI vaccine vs. Placebo for B strain~Simultaneous one-sided 97.5% confidence interval (CI) for the VE of CCI vaccine relative to Placebo was based on the Sidak-corrected score CIs for the two relative risks."|||-410|0.394
72498773|NCT00630331|144527827|SUPERIORITY_OR_OTHER_LEGACY||Vaccine Efficacy|78.4||||0.004|ONE_SIDED|97.5|52.1|||Adjusted p-values are from score statistic with Sidak correction testing the null hypothesis that the VE of IVV vs. placebo is \<= 40% (the relative risk, \>= 0.60). If adjusted p-value is \<0.025, then the comparison is statistically significant.|Sidak-corrected score CI|||"Vaccine efficacy (VE) of IVV vaccine vs. Placebo (Overall)~Simultaneous one-sided 97.5% confidence interval (CI) for the VE of IVV vaccine relative to Placebo was based on the Sidak-corrected score CIs for the two relative risks."|||52.1|0.004
72498774|NCT00630331|144527827|SUPERIORITY_OR_OTHER_LEGACY||Vaccine Efficacy|80.3||||0.002|ONE_SIDED|97.5|54.7|||Adjusted p-values are from score statistic with Sidak correction testing the null hypothesis that the VE of IVV vs. placebo is \<= 40% (the relative risk, \>= 0.60). If adjusted p-value is \<0.025, then the comparison is statistically significant.|Sidak-corrected score CI|||"Vaccine efficacy (VE) of IVV vaccine vs. Placebo for A/H1N1 strain~Simultaneous one-sided 97.5% confidence interval (CI) for the VE of IVV vaccine relative to Placebo was based on the Sidak-corrected score CIs for the two relative risks."|||54.7|0.002
72561716|NCT02367872|144654080|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|103.93|||||TWO_SIDED|95.0|59.7|180.95||||||M-I: LS mean cohort ratios for the test groups (Cohort 5R-Part 2) and the reference group (Cohort 1R) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.||180.95|59.70|
72449280|NCT04800211|144416699|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 is NOT equal to zero on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|-2.415|||<|0.0001|TWO_SIDED|95.0|-2.722|-2.107|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 is NOT equal to zero on Visit 7 (Week 12). (mITT Population)||-2.107|-2.722|<.0001
72449281|NCT04800211|144416699|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 2 is equal to zero on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 2 is NOT equal to zero on Visit 5 (Week 6). (mITT Population)|Mean Difference (Net)|-2.382|||<|0.0001|TWO_SIDED|95.0|-2.673|-2.09|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 2 is equal to zero on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 2 is NOT equal to zero on Visit 5 (Week 6). (mITT Population)||-2.090|-2.673|<.0001
72449282|NCT04800211|144416699|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 2 is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 2 is NOT equal to zero on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|-2.486|||<|0.0001|TWO_SIDED|95.0|-2.782|-2.19|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 2 is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 2 is NOT equal to zero on Visit 7 (Week 12). (mITT Population)||-2.190|-2.782|<.0001
72449283|NCT04800211|144416699|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 + Test 2 is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 + Test 2 is NOT equal to zero on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|-2.45|||<|0.0001|TWO_SIDED|95.0|-2.668|-2.233|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 + Test 2 is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 + Test 2 is NOT equal to zero on Visit 7 (Week 12). (mITT Population)||-2.233|-2.668|<.0001
72449284|NCT04800211|144416699|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Control is equal to zero on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Control is NOT equal to zero on Visit 5 (Week 6). (mITT Population)|Mean Difference (Net)|0.466||||0.0012|TWO_SIDED|95.0|0.185|0.747|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Control is equal to zero on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Control is NOT equal to zero on Visit 5 (Week 6). (mITT Population)||0.747|0.185|0.0012
72469817|NCT01936467|144463530|OTHER||Sensitivity|93.7|||||TWO_SIDED|||||||||||||
72469818|NCT01936467|144463530|OTHER||Specificity|100.0|||||TWO_SIDED|||||||||||||
72469819|NCT01936467|144463531|OTHER||Sensitivity|88.6|||||TWO_SIDED|||||||||||||
72469820|NCT01936467|144463531|OTHER||Specificity|100.0|||||TWO_SIDED|||||||||||||
72469821|NCT01936467|144463532|OTHER|||||||0.47|||||||Chi-squared|||||||0.47
72469822|NCT01936467|144463533|SUPERIORITY_OR_OTHER|||||||0.71|||||||Chi-squared|||||||0.71
72469823|NCT01936467|144463534|SUPERIORITY_OR_OTHER|||||||0.15|||||||Chi-squared|||||||0.15
72469824|NCT01936467|144463535|SUPERIORITY_OR_OTHER|||||||0.46|||||||Chi-squared|||||||0.46
72498775|NCT00630331|144527827|SUPERIORITY_OR_OTHER_LEGACY|||||||0.992||97.5||||Adjusted p-values are from score statistic with Sidak correction testing the null hypothesis that the VE of IVV vs. placebo is \<= 40% (the relative risk, \>= 0.60). If adjusted p-value is \<0.025, then the comparison is statistically significant.|Sidak-corrected score CI|For strain A/H3N2, the vaccine efficacy of the IVV vaccine vs. placebo was not evaluable since no influenza case was observed in the placebo group.||Vaccine efficacy (VE) of IVV vaccine vs. Placebo for A/H3N2 strain. Simultaneous one-sided 97.5% confidence interval (CI) for the VE of IVV vaccine relative to Placebo was based on the Sidak-corrected score CIs for the two relative risks.||||0.992
72498776|NCT00630331|144527827|SUPERIORITY_OR_OTHER_LEGACY||Vaccine Efficacy|100.0||||0.4|ONE_SIDED|97.5|-429.4|||Adjusted p-values are from score statistic with Sidak correction testing the null hypothesis that the VE of IVV vs. placebo is \<= 40% (the relative risk, \>= 0.60). If adjusted p-value is \<0.025, then the comparison is statistically significant.|Sidak-corrected score CI|||"Vaccine efficacy (VE) of IVV vaccine vs. Placebo for B strain~Simultaneous one-sided 97.5% confidence interval (CI) for the VE of IVV vaccine relative to Placebo was based on the Sidak-corrected score CIs for the two relative risks."|||-429.4|0.400
72561717|NCT02367872|144654080|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|91.97|||||TWO_SIDED|95.0|49.45|171.06||||||M-I: LS mean cohort ratios for the test groups (Cohort 2H) and the reference group (Cohort 1H) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.||171.06|49.45|
72370192|NCT04248491|144250876|SUPERIORITY|||||||0.192|||||||t-test, 2 sided|||||||0.192
72449285|NCT04800211|144416699|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Control is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Control is NOT equal to zero on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|0.099||||0.4957|TWO_SIDED|95.0|-0.187|0.386|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Control is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Control is NOT equal to zero on Visit 7 (Week 12). (mITT Population)||0.386|-0.187|0.4957
72449286|NCT04800211|144416699|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 is equal to Control on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 is NOT equal to Control on Visit 5 (Week 6). (mITT Population)|Mean Difference (Net)|-2.753|||<|0.0001|TWO_SIDED|95.0|-3.266|-2.239|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 is equal to Control on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 is NOT equal to Control on Visit 5 (Week 6). (mITT Population)||-2.239|-3.266|<.0001
72449287|NCT04800211|144416699|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|-2.514|||<|0.0001|TWO_SIDED|95.0|-3.043|-1.986|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)||-1.986|-3.043|<.0001
72469825|NCT04547023|144463541|OTHER||Mean Difference (Final Values)|18.7||||0.002|TWO_SIDED|95.0|7.2|30.1|||Fisher Exact|||||30.1|7.2|0.002
72561718|NCT02367872|144654080|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|139.33|||||TWO_SIDED|95.0|74.91|259.15||||||M-I: LS mean cohort ratios for the test groups (Cohort 3H) and the reference group (Cohort 1H) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.||259.15|74.91|
72561719|NCT02367872|144654081|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|51.39|||||TWO_SIDED|95.0|35.45|74.49||||||TAK-272F: LS mean cohort ratios for the test groups (Cohort 2R) and the reference group (Cohort 1R) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.||74.49|35.45|
72561720|NCT02367872|144654081|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|118.43|||||TWO_SIDED|95.0|81.7|171.68||||||TAK-272F: LS mean cohort ratios for the test groups (Cohort 3R) and the reference group (Cohort 1R) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.||171.68|81.70|
72561721|NCT02367872|144654081|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|272.83|||||TWO_SIDED|95.0|188.21|395.5||||||TAK-272F: LS mean cohort ratios for the test groups (Cohort 4R) and the reference group (Cohort 1R) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.||395.50|188.21|
72561722|NCT02367872|144654081|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|184.13|||||TWO_SIDED|95.0|127.02|266.91||||||TAK-272F: LS mean cohort ratios for the test groups (Cohort 5R-Part 2) and the reference group (Cohort 1R) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.||266.91|127.02|
72370193|NCT04248491|144250877|SUPERIORITY|||||||0.157|||||||t-test, 2 sided|||||||0.157
72469826|NCT00250432|144463569|NON_INFERIORITY_OR_EQUIVALENCE|Safety with caspofungin 150 mg daily will be non-inferior to that of caspofungin 70/50 mg. Non-inferiority was defined as upper limit of the 2-sided, 95% confidence interval for the difference (150-mg group - 70/50-mg group) must be less than 0.15 (15 percentage points).|Rate Difference|1.1|STANDARD_ERROR_OF_MEAN|5.6||||95.0|-4.1|6.8|||||The confidence interval computation was based on the method by Miettinen and Nurminen.|A significant drug-related adverse event was defined as either a drug-related serious adverse event or a drug-related adverse event leading to discontinuation of caspofungin therapy. Comparison between the 2 caspofungin groups was based on upper bound of the 95% confidence interval for the difference.||6.8|-4.1|
72469827|NCT00250432|144463570|SUPERIORITY_OR_OTHER||Rate Difference|6.3|STANDARD_ERROR_OF_MEAN|12.1||||95.0|-5.9|18.4|||||The 95% confidence interval on the difference will be based on the method of Miettinen and Nurminen.|There was no formal hypothesis testing for efficacy in this study. The main efficacy analysis was the number (percentage) of patients with a favorable overall response at the end of caspofungin study therapy, together with the within treatment 95% exact binomial confidence intervals, and the estimated treatment difference, and its 95% confidence interval.||18.4|-5.9|
72469828|NCT03784820|144463571|SUPERIORITY||Odds Ratio (OR)|0.35||||0.36|TWO_SIDED|95.0|0.04|3.27||Comparison of Patients at Post (T2) \[CBT-E is the reference\]|Mixed Models Analysis|||||3.27|0.04|0.36
72561723|NCT02367872|144654081|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|101.64|||||TWO_SIDED|95.0|69.04|149.64||||||TAK-272F: LS mean cohort ratios for the test groups (Cohort 2H) and the reference group (Cohort 1H) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.||149.64|69.04|
72449288|NCT04800211|144416699|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 2 is equal to Control on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 2 is NOT equal to Control on Visit 5 (Week 6). (mITT Population)|Mean Difference (Net)|-2.848|||<|0.0001|TWO_SIDED|95.0|-3.359|-2.336|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 2 is equal to Control on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 2 is NOT equal to Control on Visit 5 (Week 6). (mITT Population)||-2.336|-3.359|<.0001
72449289|NCT04800211|144416699|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|-2.586|||<|0.0001|TWO_SIDED|95.0|-3.105|-2.066|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)||-2.066|-3.105|<.0001
72449290|NCT04800211|144416699|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 + Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 + Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|-2.55|||<|0.0001|TWO_SIDED|95.0|-2.901|-2.199|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 + Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 + Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)||-2.199|-2.901|<.0001
72449291|NCT04800211|144416699|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 is equal to Test 2 on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 is NOT equal to Test 2 on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|0.071||||0.7372|TWO_SIDED|95.0|-0.346|0.489|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 is equal to Test 2 on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 is NOT equal to Test 2 on Visit 7 (Week 12). (mITT Population)||0.489|-0.346|0.7372
72449292|NCT04800211|144416700|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Whole Blood COHb (% Saturation) in Test 1 is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (MiTT Population)|Mean Difference (Net)|-3.106|||<|0.0001|TWO_SIDED|95.0|-3.502|-2.71|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Whole Blood COHb (% Saturation) in Test 1 is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (MiTT Population)||-2.710|-3.502|<.0001
72561724|NCT02367872|144654081|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|136.59|||||TWO_SIDED|95.0|92.78|201.09||||||TAK-272F: LS mean cohort ratios for the test groups (Cohort 3H) and the reference group (Cohort 1H) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.||201.09|92.78|
72561725|NCT02367872|144654081|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|59.17|||||TWO_SIDED|95.0|33.99|102.99||||||M-I: LS mean cohort ratios for the test groups (Cohort 2R) and the reference group (Cohort 1R) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.||102.99|33.99|
72370194|NCT04248491|144250878|SUPERIORITY|||||||1|||||||t-test, 2 sided|||||||1.00
72370195|NCT04248491|144250879|SUPERIORITY|||||||0.463|||||||t-test, 2 sided|||||||0.463
72561726|NCT02367872|144654081|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|97.04|||||TWO_SIDED|95.0|55.75|168.9||||||M-I: LS mean cohort ratios for the test groups (Cohort 3R) and the reference group (Cohort 1R) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.||168.90|55.75|
72561727|NCT02367872|144654081|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|260.03|||||TWO_SIDED|95.0|149.39|452.6||||||M-I: LS mean cohort ratios for the test groups (Cohort 4R) and the reference group (Cohort 1R) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.||452.60|149.39|
72561728|NCT02367872|144654081|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|319.06|||||TWO_SIDED|95.0|183.31|555.34||||||M-I: LS mean cohort ratios for the test groups (Cohort 5R-Part 2) and the reference group (Cohort 1R) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.||555.34|183.31|
72449293|NCT04800211|144416700|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Whole Blood COHb (% Saturation) in Test 1 is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (MiTT Population)|Mean Difference (Net)|-2.824|||<|0.0001|TWO_SIDED|95.0|-3.235|-2.414|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Whole Blood COHb (% Saturation) in Test 1 is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (MiTT Population)||-2.414|-3.235|<.0001
72449294|NCT04800211|144416700|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Whole Blood COHb (% Saturation) in Test 1 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (MiTT Population)|Mean Difference (Net)|-3.228|||<|0.0001|TWO_SIDED|95.0|-3.553|-2.904|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Whole Blood COHb (% Saturation) in Test 1 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (MiTT Population)||-2.904|-3.553|<.0001
72469829|NCT03784820|144463571|SUPERIORITY||Odds Ratio (OR)|0.29||||0.38|TWO_SIDED|95.0|0.02|4.6||Comparison of Patients at 3 Month Fup (T3) \[CBT-E is the reference\]|Mixed Models Analysis|||||4.60|0.02|0.38
72469830|NCT03784820|144463571|SUPERIORITY||Odds Ratio (OR)|2.2||||0.54|TWO_SIDED|95.0|0.18|27.39||Comparison of Patients at 6 Month Fup (T4) \[CBT-E is the reference\]|Mixed Models Analysis|||||27.39|0.18|0.54
72469831|NCT03784820|144463572|SUPERIORITY||LS mean difference|0.51||||0.52|TWO_SIDED|95.0|-1.06|2.09||Comparison of Patients at Post (T2)|Mixed Models Analysis|||||2.09|-1.06|0.52
72469832|NCT03784820|144463572|SUPERIORITY||LS mean difference|0.04||||0.97|TWO_SIDED|95.0|-1.99|2.07||Comparison of Patients at 3 Month Fup (T3)|Mixed Models Analysis|||||2.07|-1.99|0.97
72498777|NCT00630331|144527828|SUPERIORITY_OR_OTHER_LEGACY||Vaccine Efficacy|58.7||||0.078|ONE_SIDED|97.5|33.5|||Adjusted p-values are from score statistic with Sidak correction testing the null hypothesis that the VE of CCI vs. placebo is \<= 40% (the relative risk, \>= 0.60). If adjusted p-value is \<0.025, then the comparison is statistically significant.|Sidak-corrected score CI|||"Vaccine efficacy (VE) of CCI vaccine vs. Placebo (Overall)~Simultaneous one-sided 97.5% confidence interval (CI) for the VE of CCI vaccine relative to Placebo was based on the Sidak-corrected score CIs for the two relative risks."|||33.5|0.078
72498778|NCT00630331|144527828|SUPERIORITY_OR_OTHER_LEGACY||Vaccine Efficacy|87.3||||0.104|ONE_SIDED|97.5|4.6|||Adjusted p-values are from score statistic with Sidak correction testing the null hypothesis that the VE of CCI vs. placebo is \<= 40% (the relative risk, \>= 0.60). If adjusted p-value is \<0.025, then the comparison is statistically significant.|Sidak-corrected score CI|||"Vaccine efficacy (VE) of CCI vaccine vs. Placebo for A/H1N1 strain~Simultaneous one-sided 97.5% confidence interval (CI) for the VE of CCI vaccine relative to Placebo was based on the Sidak-corrected score CIs for the two relative risks."|||4.6|0.104
72498779|NCT00630331|144527828|SUPERIORITY_OR_OTHER_LEGACY||Vaccine Efficacy|100.0||||0.03|ONE_SIDED|97.5|36.3|||Adjusted p-values are from score statistic with Sidak correction testing the null hypothesis that the VE of CCI vs. placebo is \<= 40% (the relative risk, \>= 0.60). If adjusted p-value is \<0.025, then the comparison is statistically significant.|Sidak-corrected score CI|||"Vaccine efficacy (VE) of CCI vaccine vs. Placebo for A/H3N2 strain~Simultaneous one-sided 97.5% confidence interval (CI) for the VE of CCI vaccine relative to Placebo was based on the Sidak-corrected score CIs for the two relative risks."|||36.3|0.030
72561729|NCT02367872|144654081|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|130.07|||||TWO_SIDED|95.0|81.66|207.18||||||M-I: LS mean cohort ratios for the test groups (Cohort 2H) and the reference group (Cohort 1H) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.||207.18|81.66|
72561730|NCT02367872|144654081|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|192.63|||||TWO_SIDED|95.0|120.94|306.83||||||M-I: LS mean cohort ratios for the test groups (Cohort 3H) and the reference group (Cohort 1H) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.||306.83|120.94|
72561731|NCT02367872|144654082|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|60.22|||||TWO_SIDED|95.0|40.05|90.56||||||TAK-272F: LS mean cohort ratios for the test groups (Cohort 2R) and the reference group (Cohort 1R) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.||90.56|40.05|
72469833|NCT03784820|144463572|SUPERIORITY||LS mean difference|0.62||||0.59|TWO_SIDED|95.0|-1.66|2.89||Comparison of Patients at 6 Month Fup (T4)|Mixed Models Analysis|||||2.89|-1.66|0.59
72561732|NCT02367872|144654082|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|97.39|||||TWO_SIDED|95.0|64.77|146.46||||||TAK-272F: LS mean cohort ratios for the test groups (Cohort 3R) and the reference group (Cohort 1R) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.||146.46|64.77|
72561733|NCT02367872|144654082|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|111.6|||||TWO_SIDED|95.0|74.21|167.82||||||TAK-272F: LS mean cohort ratios for the test groups (Cohort 4R) and the reference group (Cohort 1R) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.||167.82|74.21|
72561734|NCT02367872|144654082|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|138.79|||||TWO_SIDED|95.0|92.29|208.7||||||TAK-272F: LS mean cohort ratios for the test groups (Cohort 5R-Part 2) and the reference group (Cohort 1R) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.||208.70|92.29|
72561735|NCT02367872|144654082|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|135.18|||||TWO_SIDED|95.0|87.91|207.87||||||TAK-272F: LS mean cohort ratios for the test groups (Cohort 2H) and the reference group (Cohort 1H) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.||207.87|87.91|
72561736|NCT02367872|144654082|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|323.75|||||TWO_SIDED|95.0|210.54|497.85||||||TAK-272F: LS mean cohort ratios for the test groups (Cohort 3H) and the reference group (Cohort 1H) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.||497.85|210.54|
72449295|NCT04800211|144416700|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Whole Blood COHb (% Saturation) in Test 2 is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 2 is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (MiTT Population)|Mean Difference (Net)|-2.839|||<|0.0001|TWO_SIDED|95.0|-3.221|-2.457|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Whole Blood COHb (% Saturation) in Test 2 is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 2 is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (MiTT Population)||-2.457|-3.221|<.0001
72561737|NCT02367872|144654083|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|67.61|||||TWO_SIDED|95.0|42.17|108.39||||||TAK-272F: LS mean cohort ratios for the test groups (Cohort 2R) and the reference group (Cohort 1R) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.||108.39|42.17|
72561738|NCT02367872|144654083|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|63.7|||||TWO_SIDED|95.0|39.73|102.12||||||TAK-272F: LS mean cohort ratios for the test groups (Cohort 3R) and the reference group (Cohort 1R) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.||102.12|39.73|
72561739|NCT02367872|144654083|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|84.45|||||TWO_SIDED|95.0|52.67|135.38||||||TAK-272F: LS mean cohort ratios for the test groups (Cohort 4R) and the reference group (Cohort 1R) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.||135.38|52.67|
72561740|NCT02367872|144654083|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|108.54|||||TWO_SIDED|95.0|67.7|174.01||||||TAK-272F: LS mean cohort ratios for the test groups (Cohort 5R-Part 2) and the reference group (Cohort 1R) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.||174.01|67.70|
72561741|NCT02367872|144654083|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|113.25|||||TWO_SIDED|95.0|69.62|184.24||||||TAK-272F: LS mean cohort ratios for the test groups (Cohort 2H) and the reference group (Cohort 1H) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.||184.24|69.62|
72561742|NCT02367872|144654083|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|312.89|||||TWO_SIDED|95.0|192.34|509.0||||||TAK-272F: LS mean cohort ratios for the test groups (Cohort 3H) and the reference group (Cohort 1H) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.||509.00|192.34|
72561743|NCT02367872|144654084|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|60.68|||||TWO_SIDED|95.0|40.35|91.27||||||TAK-272F: LS mean cohort ratios for the test groups (Cohort 2R) and the reference group (Cohort 1R) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.||91.27|40.35|
72561744|NCT02367872|144654084|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|98.01|||||TWO_SIDED|95.0|65.17|147.41||||||TAK-272F: LS mean cohort ratios for the test groups (Cohort 3R) and the reference group (Cohort 1R) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.||147.41|65.17|
72561745|NCT02367872|144654084|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|111.68|||||TWO_SIDED|95.0|74.25|167.96||||||TAK-272F: LS mean cohort ratios for the test groups (Cohort 4R) and the reference group (Cohort 1R) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.||167.96|74.25|
72561746|NCT02367872|144654084|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|139.7|||||TWO_SIDED|95.0|92.88|210.11||||||TAK-272F: LS mean cohort ratios for the test groups (Cohort 5R-Part 2) and the reference group (Cohort 1R) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.||210.11|92.88|
72561747|NCT02367872|144654084|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|135.08|||||TWO_SIDED|95.0|87.75|207.92||||||TAK-272F: LS mean cohort ratios for the test groups (Cohort 2H) and the reference group (Cohort 1H) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.||207.92|87.75|
72469834|NCT03784820|144463573|SUPERIORITY||LS mean difference|0.05||||0.86|TWO_SIDED|95.0|-0.45|0.54||Comparison of Patients at Post (T2)|Mixed Models Analysis|||||0.54|-0.45|0.86
72469835|NCT03784820|144463573|SUPERIORITY||LS mean difference|0.3||||0.44|TWO_SIDED|95.0|-0.46|1.06||Comparison of Patients at 3 Month Fup (T3)|Mixed Models Analysis|||||1.06|-0.46|0.44
72469836|NCT03784820|144463573|SUPERIORITY||LS mean difference|0.31||||0.36|TWO_SIDED|95.0|-0.36|0.98||Comparison of Patients at 6 Month Fup (T4)|Mixed Models Analysis|||||0.98|-0.36|0.36
72469837|NCT03784820|144463574|SUPERIORITY||LS mean difference|2.47||||0.33|TWO_SIDED|95.0|-2.54|7.49||Comparison of Patients at Post (T2)|Mixed Models Analysis|||||7.49|-2.54|0.33
72370196|NCT04248491|144250880|SUPERIORITY|||||||0.799|||||||t-test, 2 sided|||||||0.799
72370197|NCT04248491|144250881|SUPERIORITY|||||||0.757|||||||t-test, 2 sided|||||||0.757
72469838|NCT03784820|144463574|SUPERIORITY||LS mean difference|2.18||||0.46|TWO_SIDED|95.0|-3.59|7.95||Comparison of Patients at 3 Month Fup (T3)|Mixed Models Analysis|||||7.95|-3.59|0.46
72469839|NCT03784820|144463574|SUPERIORITY||LS mean difference|3.83||||0.27|TWO_SIDED|95.0|-2.94|10.6||Comparison of Patients at 6 Month Fup (T4)|Mixed Models Analysis|||||10.60|-2.94|0.27
72469840|NCT03784820|144463575|SUPERIORITY||LS mean difference|1.06||||0.62|TWO_SIDED|95.0|-3.14|5.25||Comparison of Patients at Post (T2)|Mixed Models Analysis|||||5.25|-3.14|0.62
72469841|NCT03784820|144463575|SUPERIORITY||LS mean difference|1.83||||0.54|TWO_SIDED|95.0|-4.07|7.73||Comparison of Patients at 6 Month Fup (T4)|Mixed Models Analysis|||||7.73|-4.07|0.54
72469842|NCT03784820|144463576|SUPERIORITY||LS mean difference|4.8||||0.1|TWO_SIDED|95.0|-0.91|10.51||Comparison of Patients at Post (T2)|Mixed Models Analysis|||||10.51|-0.91|0.10
72469843|NCT03784820|144463576|SUPERIORITY||LS mean difference|1.08||||0.76|TWO_SIDED|95.0|-5.97|8.13||Comparison of Patients at 3 Month Fup (T3)|Mixed Models Analysis|||||8.13|-5.97|0.76
72449296|NCT04800211|144416700|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Whole Blood COHb (% Saturation) in Test 2 is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 2 is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (MiTT Population)|Mean Difference (Net)|-2.449|||<|0.0001|TWO_SIDED|95.0|-2.828|-2.07|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Whole Blood COHb (% Saturation) in Test 2 is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 2 is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (MiTT Population)||-2.070|-2.828|<.0001
72449297|NCT04800211|144416700|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Whole Blood COHb (% Saturation) in Test2 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test2 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (MiTT Population)|Mean Difference (Net)|-3.023|||<|0.0001|TWO_SIDED|95.0|-3.328|-2.718|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Whole Blood COHb (% Saturation) in Test2 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test2 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (MiTT Population)||-2.718|-3.328|<.0001
72449298|NCT04800211|144416700|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Whole Blood COHb (% Saturation) in Test 1 + Test 2 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 + Test 2 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (MiTT Population)|Mean Difference (Net)|-3.126|||<|0.0001|TWO_SIDED|95.0|-3.354|-2.897|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Whole Blood COHb (% Saturation) in Test 1 + Test 2 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 + Test 2 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (MiTT Population)||-2.897|-3.354|<.0001
72469493|NCT01515943|144462717|SUPERIORITY_OR_OTHER||Risk Difference (RD)|5.0||||0.52|TWO_SIDED|97.5|-12.0|22.0||Linear contrasts performed with a type I error rate of 2.5% based on a Bonferroni adjustment (overall type I error rate of 5% for 2 pairwise treatment group comparisons).|Binomial regression|Adjusted for baseline covariates of CISS score, mean NPC break and mean PFV blur. Linear contrasts performed with Bonferroni adjustment (alpha=0.025)|Positive values for the treatment group difference favor the HB-C group. Results of the treatment group comparison are adjusted for baseline covariates of CISS, mean NPC break and mean PFV blur.|The primary outcome was success at 12 weeks. The sample size was computed to have 90% power to detect a treatment group difference between the HB-C versus HB-P groups, assuming true population success percentages of 30% and 10% for the HB-C and HB-PU groups, respectively, with a type I error rate of 2.5%. The treatment group comparison was adjusted for baseline covariates of CISS score (\<28 points vs ≥28 points), mean NPC break (\<10 cm vs ≥10 cm) and mean PFV blur (≥15 pd vs \<15 pd).||22|-12|0.52
72498780|NCT00630331|144527828|SUPERIORITY_OR_OTHER_LEGACY||Vaccine Efficacy|50.0||||0.376|ONE_SIDED|97.5|17.5|||Adjusted p-values are from score statistic with Sidak correction testing the null hypothesis that the VE of CCI vs. placebo is \<= 40% (the relative risk, \>= 0.60). If adjusted p-value is \<0.025, then the comparison is statistically significant.|Sidak-corrected score CI|||"Vaccine efficacy (VE) of CCI vaccine vs. Placebo for B strain~Simultaneous one-sided 97.5% confidence interval (CI) for the VE of CCI vaccine relative to Placebo was based on the Sidak-corrected score CIs for the two relative risks."|||17.5|0.376
72498781|NCT00630331|144527828|SUPERIORITY_OR_OTHER_LEGACY||Vaccine Efficacy|58.6||||0.085|ONE_SIDED|97.5|32.9|||Adjusted p-values are from score statistic with Sidak correction testing the null hypothesis that the VE of IVV vs. placebo is \<= 40% (the relative risk, \>= 0.60). If adjusted p-value is \<0.025, then the comparison is statistically significant.|Sidak-corrected score CI|||"Vaccine efficacy (VE) of IVV vaccine vs. Placebo (Overall)~Simultaneous one-sided 97.5% confidence interval (CI) for the VE of IVV vaccine relative to Placebo was based on the Sidak-corrected score CIs for the two relative risks."|||32.9|0.085
72561748|NCT02367872|144654084|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|325.28|||||TWO_SIDED|95.0|211.32|500.7||||||TAK-272F: LS mean cohort ratios for the test groups (Cohort 3H) and the reference group (Cohort 1H) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.||500.70|211.32|
72561749|NCT02625298|144654096|OTHER||||||<|0.01|||||||Mixed Models Analysis|||||||<0.01
72561750|NCT05068284|144654099|SUPERIORITY||Risk Difference (RD)|7.1|||||TWO_SIDED|95.0|-6.3|20.6|||||Risk difference = (ABBV-154 - placebo)|||20.6|-6.3|
72561751|NCT05068284|144654099|SUPERIORITY||Risk Difference (RD)|33.3|||||TWO_SIDED|95.0|6.7|60.0|||||Risk difference = (ABBV-154 - placebo)|||60.0|6.7|
72561752|NCT05068284|144654099|SUPERIORITY||Risk Difference (RD)|28.6|||||TWO_SIDED|95.0|4.9|52.2|||||Risk difference = (ABBV-154 - placebo)|||52.2|4.9|
72561753|NCT05068284|144654099|SUPERIORITY||Risk Difference (RD)|27.3|||||TWO_SIDED|95.0|1.0|53.6|||||Risk difference = (ABBV-154 - placebo)|||53.6|1.0|
72561754|NCT05068284|144654100|SUPERIORITY||Risk Difference (RD)|11.9|||||TWO_SIDED|95.0|-19.8|43.6|||||Risk difference = (ABBV-154 - placebo)|||43.6|-19.8|
72370198|NCT04248491|144250882|SUPERIORITY|||||||0.472|||||||t-test, 2 sided|||||||0.472
72370199|NCT04248491|144250884|SUPERIORITY|||||||0.342|||||||t-test, 2 sided|||||||0.342
72449299|NCT04800211|144416700|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Whole Blood COHb (% Saturation) in Control is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Control is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (MiTT Population)|Mean Difference (Net)|0.908|||<|0.0001|TWO_SIDED|95.0|0.518|1.298|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Whole Blood COHb (% Saturation) in Control is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Control is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (MiTT Population)||1.298|0.518|<.0001
72449300|NCT04800211|144416700|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Whole Blood COHb (% Saturation) in Control is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Control is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (MiTT Population)|Mean Difference (Net)|1.291|||<|0.0001|TWO_SIDED|95.0|0.902|1.679|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Whole Blood COHb (% Saturation) in Control is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Control is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (MiTT Population)||1.679|0.902|<.0001
72449301|NCT04800211|144416700|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Whole Blood COHb (% Saturation) in Control is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Control is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (MiTT Population)|Mean Difference (Net)|0.174||||0.2772|TWO_SIDED|95.0|-0.142|0.49|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Whole Blood COHb (% Saturation) in Control is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Control is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (MiTT Population)||0.490|-0.142|0.2772
72449302|NCT04800211|144416700|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Whole Blood COHb (% Saturation) in Test 1 is equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 is NOT equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (MiTT Population)|Mean Difference (Net)|-4.014|||<|0.0001|TWO_SIDED|95.0|-4.75|-3.278|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Whole Blood COHb (% Saturation) in Test 1 is equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 is NOT equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (MiTT Population)||-3.278|-4.750|<.0001
72449303|NCT04800211|144416700|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Whole Blood COHb (% Saturation) in Test 1 is equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 is NOT equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (MiTT Population)|Mean Difference (Net)|-4.115|||<|0.0001|TWO_SIDED|95.0|-4.865|-3.365|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Whole Blood COHb (% Saturation) in Test 1 is equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 is NOT equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (MiTT Population)||-3.365|-4.865|<.0001
72449304|NCT04800211|144416700|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Whole Blood COHb (% Saturation) in Test 1 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (MiTT Population)|Mean Difference (Net)|-3.403|||<|0.0001|TWO_SIDED|95.0|-4.005|-2.801|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Whole Blood COHb (% Saturation) in Test 1 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (MiTT Population)||-2.801|-4.005|<.0001
72469844|NCT03784820|144463576|SUPERIORITY||LS mean difference|3.26||||0.23|TWO_SIDED|95.0|-2.03|8.55||Comparison of Patients at 6 Month Fup (T4)|Mixed Models Analysis|||||8.55|-2.03|0.23
72469845|NCT03784820|144463576|SUPERIORITY||LS mean difference|-0.25||||0.94|TWO_SIDED|95.0|-6.63|6.14||Comparison of Partners at Post (T2)|Mixed Models Analysis|||||6.14|-6.63|0.94
72449305|NCT04800211|144416700|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Whole Blood COHb (% Saturation) in Test 2 is equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 2 is NOT equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (MiTT Population)|Mean Difference (Net)|-3.747|||<|0.0001|TWO_SIDED|95.0|-4.473|-3.02|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Whole Blood COHb (% Saturation) in Test 2 is equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 2 is NOT equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (MiTT Population)||-3.020|-4.473|<.0001
72449306|NCT04800211|144416700|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Whole Blood COHb (% Saturation) in Test 2 is equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 2 is NOT equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (MiTT Population)|Mean Difference (Net)|-3.74|||<|0.0001|TWO_SIDED|95.0|-4.461|-3.018|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Whole Blood COHb (% Saturation) in Test 2 is equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 2 is NOT equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (MiTT Population)||-3.018|-4.461|<.0001
72469494|NCT01515943|144462723|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-7.0|||<|0.01|TWO_SIDED|95.0|-27.0|17.0|||Bernard's exact test|A p-value was not reported in the manuscript results, but has been included here, reported directly from the analysis.||For the HB-C group, the association between completion of the computer vergence/accommodative therapy (CVAT) program (defined as achieving at least 15 stars for the jump vergence exercise) and overall success at 12 weeks was evaluated using Bernard's exact test.||17|-27|<0.01
72469495|NCT05224843|144462730|OTHER||Percentage of enrolled from eligible|82.5|||||TWO_SIDED|95.0|73.7|88.8||||||||88.8|73.7|
72469496|NCT05224843|144462731|OTHER||Percentage of enrolled from eligible|100.0|||||TWO_SIDED|95.0|95.4|100.0||||||||100|95.4|
72561755|NCT05068284|144654100|SUPERIORITY||Risk Difference (RD)|29.5|||||TWO_SIDED|95.0|-4.8|63.8|||||Risk difference = (ABBV-154 - placebo)|||63.8|-4.8|
72561756|NCT05068284|144654100|SUPERIORITY||Risk Difference (RD)|19.0|||||TWO_SIDED|95.0|-13.7|51.8|||||Risk difference = (ABBV-154 - placebo)|||51.8|-13.7|
72561757|NCT05068284|144654100|SUPERIORITY||Risk Difference (RD)|23.3|||||TWO_SIDED|95.0|-13.6|60.3|||||Risk difference = (ABBV-154 - placebo)|||60.3|-13.6|
72561758|NCT05068284|144654101|SUPERIORITY||Risk Difference (RD)|11.3|||||TWO_SIDED|95.0|-18.5|41.0|||||Risk difference = (ABBV-154 - placebo)|||41.0|-18.5|
72561759|NCT05068284|144654101|SUPERIORITY||Risk Difference (RD)|38.5|||||TWO_SIDED|95.0|5.0|71.9|||||Risk difference = (ABBV-154 - placebo)|||71.9|5.0|
72469497|NCT05224843|144462733|OTHER||Percentage screened positive for EM|7.5|||||TWO_SIDED|95.0|3.5|15.4||||||||15.4|3.5|
72469498|NCT05224843|144462735|OTHER||Percentage who changed after BNI|25.0|||||TWO_SIDED|95.0|4.6|69.9||||||||69.9|4.6|
72469499|NCT05224843|144462736|OTHER||Percentage reported APS from EM positive|20.0|||||TWO_SIDED|95.0|3.6|62.4||||||||62.4|3.6|
72469500|NCT01245140|144462766|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.5731||||0.9705|TWO_SIDED|95.0|-30.9738|32.12|||ANCOVA|||||32.1200|-30.9738|0.9705
72469501|NCT01245140|144462767|SUPERIORITY_OR_OTHER|||||||0.4564||95.0||||PPPASI 50 response|Fisher Exact|||||||0.4564
72469502|NCT01245140|144462767|SUPERIORITY_OR_OTHER|||||||0.6595||95.0||||PPPASI 75 response|Fisher Exact|||||||0.6595
72469503|NCT01245140|144462769|SUPERIORITY_OR_OTHER|||||||0.51||95.0||||Change in Total Pustule Count: BL to Last Visit|Wilcoxon test: Exact Test|||||||0.51
72469504|NCT01245140|144462770|SUPERIORITY_OR_OTHER|||||||0.12||95.0||||Relative change in mPASI score: BL to Last Visit|Wilcoxon test: Exact Test|||||||0.12
72469505|NCT01245140|144462771|SUPERIORITY_OR_OTHER||Least squared estimation|49.4927||||0.2358|TWO_SIDED|95.0|-49.083|148.07|||ANCOVA|||||148.07|-49.0830|0.2358
72469506|NCT01245140|144462772|SUPERIORITY_OR_OTHER|||||||0.1667||95.0||||mPASI 50 response|Fisher Exact|||||||0.1667
72469507|NCT01245140|144462772|SUPERIORITY_OR_OTHER|||||||0.1667||95.0||||mPASI 75 response|Fisher Exact|||||||0.1667
72469508|NCT04836559|144462791|SUPERIORITY||Hazard Ratio (HR)|0.75||||0.3571|TWO_SIDED|95.0|0.41|1.38|||t-test, 1 sided|||||1.38|0.41|0.3571
72469509|NCT04836559|144462791|SUPERIORITY||Hazard Ratio (HR)|0.83||||0.6306|TWO_SIDED|95.0|0.4|1.75|||t-test, 1 sided|||||1.75|0.40|0.6306
72469510|NCT02701062|144462824|SUPERIORITY|||||||0.2593|||||||Fisher Exact|||||||0.2593
72469511|NCT02701062|144462825|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.000
72469512|NCT02701062|144462826|SUPERIORITY|||||||0.1238|||||||Fisher Exact|||||||0.1238
72469513|NCT02701062|144462827|SUPERIORITY|||||||0.6603|||||||t-test, 2 sided|||LOS (Total)||||0.6603
72469514|NCT02701062|144462827|SUPERIORITY|||||||0.0783|||||||t-test, 2 sided|||LOS (Post-Procedure)||||0.0783
72469515|NCT02701062|144462827|SUPERIORITY|||||||0.4282|||||||t-test, 2 sided|||Readmission LOS (per subject)||||0.4282
72469516|NCT02701062|144462828|SUPERIORITY|||||||0.6603|||||||t-test, 2 sided|||||||0.6603
72469517|NCT02701062|144462828|SUPERIORITY|||||||0.0783|||||||t-test, 2 sided|||LOS (Post-Procedure)||||0.0783
72469518|NCT02701062|144462828|SUPERIORITY|||||||0.4282|||||||t-test, 2 sided|||Readmission LOS (per subject)||||0.4282
72469519|NCT02701062|144462829|SUPERIORITY|||||||0.5442|||||||Fisher Exact|||Reoperation||||0.5442
72469520|NCT02701062|144462829|SUPERIORITY|||||||0.2598|||||||Fisher Exact|||ED Visit||||0.2598
72469521|NCT02701062|144462829|SUPERIORITY|||||||0.5442|||||||Fisher Exact|||Neurologic Consult||||0.5442
72469522|NCT02701062|144462829|SUPERIORITY|||||||0.2921|||||||Fisher Exact|||Hospital Readmission (per subject)||||0.2921
72619545|NCT03537729|144769952|SUPERIORITY|Power was based on planned 12 sites and effect size Cohen's d=0.42 for pairwise differences between arms, intraclass correlation coefficient of 0.0012, and reduction in variance due to adjustment for baseline and repeated measures with correlation of 0.4 between pairs of measures. The sample size requirement was 38 per group, or 114 total for power of .80 in two-sided tests at .05 level of significance.|Mean Difference (Final Values)|0.14|STANDARD_ERROR_OF_MEAN|0.12||0.23|TWO_SIDED|95.0|-0.09|0.38||P-value was not adjusted for multiple comparisons. A priori threshold for statistical significance was .05.|Mixed Models Analysis|Covariates included baseline value of the outcome, age, sex, and cognition score at baseline, and use of wheelchair on the route.|Cues minus control|The null hypothesis was that means of two arms on the moderate complexity route are equal, the alternative was that means were not equal.||0.38|-0.09|.23
72449307|NCT04800211|144416700|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Whole Blood COHb (% Saturation) in Test 2 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 2 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (MiTT Population)|Mean Difference (Net)|-3.197|||<|0.0001|TWO_SIDED|95.0|-3.784|-2.61|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Whole Blood COHb (% Saturation) in Test 2 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 2 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (MiTT Population)||-2.610|-3.784|<.0001
72561760|NCT05068284|144654101|SUPERIORITY||Risk Difference (RD)|24.6|||||TWO_SIDED|95.0|-7.0|56.2|||||Risk difference = (ABBV-154 - placebo)|||56.2|-7.0|
72561761|NCT05068284|144654101|SUPERIORITY||Risk Difference (RD)|39.2|||||TWO_SIDED|95.0|3.8|74.5|||||Risk difference = (ABBV-154 - placebo)|||74.5|3.8|
72561762|NCT02293460|144654152|SUPERIORITY|The response rate was tested against the historical response rate of 33.3%.|Responder rate|76.2|||<|0.0001|TWO_SIDED|95.0|60.5|87.9||One-sided test at nominal level of significance alpha = 2.5 %|exact binomial Clopper-Pearson|||"For this single-arm study, the response rate was tested against the historical response rate of 33.3% with a 1-sided Clopper-Pearson exact test at the nominal level of significance of 2.5% on the Full Analysis Set. The null and alternative hypotheses were as follows:~H0: pI10E \<= 33.3% H1: pI10E \> 33.3%"||87.9|60.5|<0.0001
72619546|NCT03537729|144769952|SUPERIORITY|Power was based on planned 12 sites and effect size Cohen's d=0.42 for pairwise differences between arms, intraclass correlation coefficient of 0.0012, and reduction in variance due to adjustment for baseline and repeated measures with correlation of 0.4 between pairs of measures. The sample size requirement was 38 per group, or 114 total for power of .80 in two-sided tests at .05 level of significance.|Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.12||0.9|TWO_SIDED|95.0|-0.25|0.22||P-value was not adjusted for multiple comparisons. A priori threshold for statistical significance was .05.|Mixed Models Analysis|Covariates included baseline value of the outcome, age, sex, and cognition score at baseline, and use of wheelchair on the route.|Spaced retrieval minus control|The null hypothesis was that means of two arms on the moderate complexity route are equal, the alternative was that means were not equal.||0.22|-0.25|.90
72622402|NCT03131479|144774710|EQUIVALENCE|Change from baseline was analyzed using a repeated measures model which included diabetic status, renal function, day and renal function\*day and diabetic status\*day as fixed factors and age, baseline body weight and baseline fasting plasma glucose as covariates.|adjusted arithmetic mean difference|-9.21||||0.154|TWO_SIDED|90.0|-19.88|1.45|||Regression, Logistic|An unstructured variance-covariance structure was used. Baseline is defined to be the measurement collected on Day -1.||||1.45|-19.88|0.154
72370200|NCT03364270|144250939|OTHER||Mean Difference (Final Values)|0.58||||0.001|TWO_SIDED|95.0|0.33|0.84||Threshold p\<0.05|t-test, 2 sided|||Null hypothesis: There is no difference in mean 18F-RGD uptake (expressed as a target to background ratio) in the culprit artery (carotid artery implicated in stroke or transient ischemic attack \[TIA\]) when compared to mean 18F-RGD uptake in the contralateral carotid artery. A paired t-test was used to compare 18F-RGD uptake in culprit plaque to plaque in the contralateral artery.||0.84|0.33|.001
72449308|NCT04800211|144416700|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Whole Blood COHb (% Saturation) in Test 1 + Test 2 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 + Test 2 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (MiTT Population)|Mean Difference (Net)|-3.3|||<|0.0001|TWO_SIDED|95.0|-3.678|-2.921|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Whole Blood COHb (% Saturation) in Test 1 + Test 2 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 + Test 2 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (MiTT Population)||-2.921|-3.678|<.0001
72449309|NCT04800211|144416700|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Whole Blood COHb (% Saturation) in Test 2 is equal to Test 1 on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 2 is NOT equal to Test 1 on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (MiTT Population)|Mean Difference (Net)|-0.206||||0.348|TWO_SIDED|95.0|-0.638|0.226|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Whole Blood COHb (% Saturation) in Test 2 is equal to Test 1 on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 2 is NOT equal to Test 1 on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (MiTT Population)||0.226|-0.638|0.3480
72449310|NCT04800211|144416701|EQUIVALENCE|Null hypothesis: Whole Blood WBC (x 10\^3/uL) in Test 1 is equal to zero on Visit 5. Alternate hypothesis: Whole Blood WBC (x 10\^3/uL) in Test 1 is NOT equal to zero on Visit 5. (mITT Population)|Mean Difference (Net)|-0.716|||<|0.0001|TWO_SIDED|95.0|-0.951|-0.481|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Whole Blood WBC (x 10\^3/uL) in Test 1 is equal to zero on Visit 5. Alternate hypothesis: Whole Blood WBC (x 10\^3/uL) in Test 1 is NOT equal to zero on Visit 5. (mITT Population)||-0.481|-0.951|<0.0001
72449311|NCT04800211|144416701|EQUIVALENCE|Null hypothesis: Whole Blood WBC (x 10\^3/uL) in Test 1 is equal to zero on Visit 7. Alternate hypothesis: Whole Blood WBC (x 10\^3/uL) in Test 1 is NOT equal to zero on Visit 7. (mITT Population)|Mean Difference (Net)|-0.686|||<|0.0001|TWO_SIDED|95.0|-0.966|-0.406|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Whole Blood WBC (x 10\^3/uL) in Test 1 is equal to zero on Visit 7. Alternate hypothesis: Whole Blood WBC (x 10\^3/uL) in Test 1 is NOT equal to zero on Visit 7. (mITT Population)||-0.406|-0.966|<0.0001
72449312|NCT04800211|144416701|EQUIVALENCE|Null hypothesis: Whole Blood WBC (x 10\^3/uL) in Test 2 is equal to zero on Visit 5. Alternate hypothesis: Whole Blood WBC (x 10\^3/uL) in Test 2 is NOT equal to zero on Visit 5. (mITT Population)|Mean Difference (Net)|-0.521|||<|0.0001|TWO_SIDED|95.0|-0.755|-0.288|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Whole Blood WBC (x 10\^3/uL) in Test 2 is equal to zero on Visit 5. Alternate hypothesis: Whole Blood WBC (x 10\^3/uL) in Test 2 is NOT equal to zero on Visit 5. (mITT Population)||-0.288|-0.755|<.0001
72449313|NCT04800211|144416701|EQUIVALENCE|Null hypothesis: Whole Blood WBC (x 10\^3/uL) in Test 2 is equal to zero on Visit 7. Alternate hypothesis: Whole Blood WBC (x 10\^3/uL) in Test 2 is NOT equal to zero on Visit 7. (mITT Population)|Mean Difference (Net)|-0.342||||0.0131|TWO_SIDED|95.0|-0.612|-0.072|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Whole Blood WBC (x 10\^3/uL) in Test 2 is equal to zero on Visit 7. Alternate hypothesis: Whole Blood WBC (x 10\^3/uL) in Test 2 is NOT equal to zero on Visit 7. (mITT Population)||-0.072|-0.612|0.0131
72449314|NCT04800211|144416701|EQUIVALENCE|Null hypothesis: Whole Blood WBC (x 10\^3/uL) in Test 1 + Test 2 is equal to zero on Visit 7. Alternate hypothesis: Whole Blood WBC (x 10\^3/uL) in Test 1 + Test 2 is NOT equal to zero on Visit 7. (mITT Population)|Mean Difference (Net)|-0.514|||<|0.0001|TWO_SIDED|95.0|-0.712|-0.316|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Whole Blood WBC (x 10\^3/uL) in Test 1 + Test 2 is equal to zero on Visit 7. Alternate hypothesis: Whole Blood WBC (x 10\^3/uL) in Test 1 + Test 2 is NOT equal to zero on Visit 7. (mITT Population)||-0.316|-0.712|<.0001
72449315|NCT04800211|144416701|EQUIVALENCE|Null hypothesis: Whole Blood WBC (x 10\^3/uL) in Control is equal to zero on Visit 5. Alternate hypothesis: Whole Blood WBC (x 10\^3/uL) in Control is NOT equal to zero on Visit 5. (mITT Population)|Mean Difference (Net)|-0.231||||0.0435|TWO_SIDED|95.0|-0.455|-0.007|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Whole Blood WBC (x 10\^3/uL) in Control is equal to zero on Visit 5. Alternate hypothesis: Whole Blood WBC (x 10\^3/uL) in Control is NOT equal to zero on Visit 5. (mITT Population)||-0.007|-0.455|0.0435
72449316|NCT04800211|144416701|EQUIVALENCE|Null hypothesis: Whole Blood WBC (x 10\^3/uL) in Control is equal to zero on Visit 7. Alternate hypothesis: Whole Blood WBC (x 10\^3/uL) in Control is NOT equal to zero on Visit 7. (mITT Population)|Mean Difference (Net)|0.111||||0.4012|TWO_SIDED|95.0|-0.149|0.371|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Whole Blood WBC (x 10\^3/uL) in Control is equal to zero on Visit 7. Alternate hypothesis: Whole Blood WBC (x 10\^3/uL) in Control is NOT equal to zero on Visit 7. (mITT Population)||0.371|-0.149|0.4012
72449317|NCT04800211|144416701|EQUIVALENCE|Null hypothesis: Whole Blood WBC (x 10\^3/uL) in Test 1 is equal to Control on Visit 5. Alternate hypothesis: Whole Blood WBC (x 10\^3/uL) in Test 1 is NOT equal to Control on Visit 5. (mITT Population)|Mean Difference (Net)|-0.485||||0.0133|TWO_SIDED|95.0|-0.895|-0.074|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Whole Blood WBC (x 10\^3/uL) in Test 1 is equal to Control on Visit 5. Alternate hypothesis: Whole Blood WBC (x 10\^3/uL) in Test 1 is NOT equal to Control on Visit 5. (mITT Population)||-0.074|-0.895|0.0133
72561763|NCT01074008|144654157|SUPERIORITY_OR_OTHER||||||<|0.001||||||There was no adjustment for multiple comparisons and the pre-specified, two-sided significance level was ≤ 0.05.|ANCOVA|Treatment was the factor and baseline log10 HCV RNA level was the covariate.||Eight participants per ABT-450/r group and 11 participants in the placebo group would provide \> 95% power to detect a 1.0 log10 difference with a common standard deviation of 0.5 log10 IU/mL using a two-sided, two-sample t-test with a significance level of 0.05.||||<0.001
72561764|NCT01074008|144654157|SUPERIORITY_OR_OTHER||||||<|0.001||||||There was no adjustment for multiple comparisons and the pre-specified, two-sided significance level was ≤ 0.05.|ANCOVA|Treatment was the factor and baseline log10 HCV RNA level was the covariate.||Eight participants per ABT-450/r group and 11 participants in the placebo group would provide \> 95% power to detect a 1.0 log10 difference with a common standard deviation of 0.5 log10 IU/mL using a two-sided, two-sample t-test with a significance level of 0.05.||||<0.001
72449318|NCT04800211|144416701|EQUIVALENCE|Null hypothesis: Whole Blood WBC (x 10\^3/uL) in Test 1 is equal to Control on Visit 7. Alternate hypothesis: Whole Blood WBC (x 10\^3/uL) in Test 1 is NOT equal to Control on Visit 7. (mITT Population)|Mean Difference (Net)|-0.797||||0.0002|TWO_SIDED|95.0|-1.277|-0.317|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Whole Blood WBC (x 10\^3/uL) in Test 1 is equal to Control on Visit 7. Alternate hypothesis: Whole Blood WBC (x 10\^3/uL) in Test 1 is NOT equal to Control on Visit 7. (mITT Population)||-0.317|-1.277|0.0002
72449319|NCT04800211|144416701|EQUIVALENCE|Null hypothesis: Whole Blood WBC (x 10\^3/uL) in Test 2 is equal to Control on Visit 5. Alternate hypothesis: Whole Blood WBC (x 10\^3/uL) in Test 2 is NOT equal to Control on Visit 5. (mITT Population)|Mean Difference (Net)|-0.29||||0.2641|TWO_SIDED|95.0|-0.699|0.119|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Whole Blood WBC (x 10\^3/uL) in Test 2 is equal to Control on Visit 5. Alternate hypothesis: Whole Blood WBC (x 10\^3/uL) in Test 2 is NOT equal to Control on Visit 5. (mITT Population)||0.119|-0.699|0.2641
72449320|NCT04800211|144416701|EQUIVALENCE|Null hypothesis: Whole Blood WBC (x 10\^3/uL) in Test 2 is equal to Control on Visit 7. Alternate hypothesis: Whole Blood WBC (x 10\^3/uL) in Test 2 is NOT equal to Control on Visit 7. (mITT Population)|Mean Difference (Net)|-0.453||||0.0639|TWO_SIDED|95.0|-0.924|0.018|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Whole Blood WBC (x 10\^3/uL) in Test 2 is equal to Control on Visit 7. Alternate hypothesis: Whole Blood WBC (x 10\^3/uL) in Test 2 is NOT equal to Control on Visit 7. (mITT Population)||0.018|-0.924|0.0639
72449321|NCT04800211|144416701|EQUIVALENCE|Null hypothesis: Whole Blood WBC (x 10\^3/uL) in Test 1 + Test 2 is equal to Control on Visit 7. Alternate hypothesis: Whole Blood WBC (x 10\^3/uL) in Test 1 + Test 2 is NOT equal to Control on Visit 7. (mITT Population)|Mean Difference (Net)|-0.625||||0.0001|TWO_SIDED|95.0|-0.945|-0.305|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Whole Blood WBC (x 10\^3/uL) in Test 1 + Test 2 is equal to Control on Visit 7. Alternate hypothesis: Whole Blood WBC (x 10\^3/uL) in Test 1 + Test 2 is NOT equal to Control on Visit 7. (mITT Population)||-0.305|-0.945|0.0001
72449322|NCT04800211|144416701|EQUIVALENCE|Null hypothesis: Whole Blood WBC (x 10\^3/uL) in Test 1 is equal to Test 2 on Visit 7. Alternate hypothesis: Whole Blood WBC (x 10\^3/uL) in Test 1 is NOT equal to Test 2 on Visit 7. (mITT Population)|Mean Difference (Net)|-0.344||||0.0776|TWO_SIDED|95.0|-0.725|0.038|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Whole Blood WBC (x 10\^3/uL) in Test 1 is equal to Test 2 on Visit 7. Alternate hypothesis: Whole Blood WBC (x 10\^3/uL) in Test 1 is NOT equal to Test 2 on Visit 7. (mITT Population)||0.038|-0.725|0.0776
72449323|NCT04800211|144416702|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Whole Blood WBC (x 10\^3/uL) in Test 1 is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood WBC (x 10\^3/uL) in Test 1 is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-0.621||||0.0055|TWO_SIDED|95.0|-1.055|-0.186|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Whole Blood WBC (x 10\^3/uL) in Test 1 is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood WBC (x 10\^3/uL) in Test 1 is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||-0.186|-1.055|0.0055
72449324|NCT04800211|144416702|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Whole Blood WBC (x 10\^3/uL) in Test 1 is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood WBC (x 10\^3/uL) in Test 1 is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-0.778||||0.0011|TWO_SIDED|95.0|-1.24|-0.316|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Whole Blood WBC (x 10\^3/uL) in Test 1 is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood WBC (x 10\^3/uL) in Test 1 is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||-0.316|-1.240|0.0011
72469846|NCT03784820|144463576|SUPERIORITY||LS mean difference|-1.46||||0.68|TWO_SIDED|95.0|-8.38|5.46||Comparison of Partners at 3 Month Fup (T3)|Mixed Models Analysis|||||5.46|-8.38|0.68
72469847|NCT03784820|144463576|SUPERIORITY||LS mean difference|-0.61||||0.89|TWO_SIDED|95.0|-9.06|7.84||Comparison of Partners at 6 Month Fup (T4)|Mixed Models Analysis|||||7.84|-9.06|0.89
72469848|NCT03784820|144463577|SUPERIORITY||LS mean difference|-0.41||||0.91|TWO_SIDED|95.0|-7.61|6.79||Comparison of Patients at Post (T2)|Mixed Models Analysis|||||6.79|-7.61|0.91
72469849|NCT03784820|144463577|SUPERIORITY||LS mean difference|4.72||||0.2|TWO_SIDED|95.0|-2.49|11.93||Comparison of Patients at 3 Month Fup (T3)|Mixed Models Analysis|||||11.93|-2.49|0.20
72370201|NCT02910986|144250951|SUPERIORITY||||||>|0.05|||||||Chi-squared|||The percentage with improved knowledge (defined as having an incorrect response at T0 and a correct response at T1) was compared between study groups with chi-square tests.||||> 0.05
72449325|NCT04800211|144416702|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Whole Blood WBC (x 10\^3/uL) in Test 1 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood WBC (x 10\^3/uL) in Test 1 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-0.9|||<|0.0001|TWO_SIDED|95.0|-1.26|-0.54|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Whole Blood WBC (x 10\^3/uL) in Test 1 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood WBC (x 10\^3/uL) in Test 1 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||-0.540|-1.260|<.0001
72449326|NCT04800211|144416702|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Whole Blood WBC (x 10\^3/uL) in Test 2 is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood WBC (x 10\^3/uL) in Test 2 is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-0.52||||0.015|TWO_SIDED|95.0|-0.938|-0.103|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Whole Blood WBC (x 10\^3/uL) in Test 2 is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood WBC (x 10\^3/uL) in Test 2 is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||-0.103|-0.938|0.0150
72449327|NCT04800211|144416702|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Whole Blood WBC (x 10\^3/uL) in Test 2 is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood WBC (x 10\^3/uL) in Test 2 is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-0.349||||0.1048|TWO_SIDED|95.0|-0.771|0.074|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Whole Blood WBC (x 10\^3/uL) in Test 2 is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood WBC (x 10\^3/uL) in Test 2 is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||0.074|-0.771|0.1048
72469850|NCT03784820|144463577|SUPERIORITY||LS mean difference|4.78||||0.14|TWO_SIDED|95.0|-1.63|11.2||Comparison of Patients at 6 Month Fup (T4)|Mixed Models Analysis|||||11.20|-1.63|0.14
72561765|NCT01074008|144654157|SUPERIORITY_OR_OTHER||||||<|0.001||||||There was no adjustment for multiple comparisons and the pre-specified, two-sided significance level was ≤ 0.05.|ANCOVA|Treatment was the factor and baseline log10 HCV RNA level was the covariate.||Eight participants per ABT-450/r group and 11 participants in the placebo group would provide \> 95% power to detect a 1.0 log10 difference with a common standard deviation of 0.5 log10 IU/mL using a two-sided, two-sample t-test with a significance level of 0.05.||||<0.001
72370202|NCT02910986|144250952|SUPERIORITY|||||||0.56||||||The priori threshold for statistical significance was 0.05|Chi-squared|||||||0.56
72469851|NCT03784820|144463577|SUPERIORITY||LS mean difference|3.86||||0.25|TWO_SIDED|95.0|-2.76|10.49||Comparison of Partners at Post (T2)|Mixed Models Analysis|||||10.49|-2.76|0.25
72469852|NCT03784820|144463577|SUPERIORITY||LS mean difference|4.22||||0.14|TWO_SIDED|95.0|-1.45|9.89||Comparison of Partners at 3 Month Fup (T3)|Mixed Models Analysis|||||9.89|-1.45|0.14
72469853|NCT03784820|144463577|SUPERIORITY||LS mean difference|3.15||||0.28|TWO_SIDED|95.0|-2.58|8.87||Comparison of Partners at 6 Month Fup (T4)|Mixed Models Analysis|||||8.87|-2.58|0.28
72469854|NCT03784820|144463578|SUPERIORITY||LS mean difference|1.73||||0.85|TWO_SIDED|95.0|-16.73|20.19||Comparison of Patients at Post (T2)|Mixed Models Analysis|||||20.19|-16.73|0.85
72469855|NCT03784820|144463578|SUPERIORITY||LS mean difference|7.94||||0.47|TWO_SIDED|95.0|-13.59|29.48||Comparison of Patients at 3 Month Fup (T3)|Mixed Models Analysis|||||29.48|-13.59|0.47
72469856|NCT03784820|144463578|SUPERIORITY||LS mean difference|9.79||||0.37|TWO_SIDED|95.0|-11.5|31.08||Comparison of Patients at 6 Month Fup (T4)|Mixed Models Analysis|||||31.08|-11.50|0.37
72469857|NCT03784820|144463578|SUPERIORITY||LS mean difference|0.36||||0.97|TWO_SIDED|95.0|-19.31|20.03||Comparison of Partners at Post (T2)|Mixed Models Analysis|||||20.03|-19.31|0.97
72469858|NCT03784820|144463578|SUPERIORITY||LS mean difference|-5.88||||0.52|TWO_SIDED|95.0|-23.85|12.09||Comparison of Partners at 3 Month Fup (T3)|Mixed Models Analysis|||||12.09|-23.85|0.52
72469859|NCT03784820|144463578|SUPERIORITY||LS mean difference|-3.55||||0.68|TWO_SIDED|95.0|-20.33|13.23||Comparison of Partners at 6 Month Fup (T4)|Mixed Models Analysis|||||13.23|-20.33|0.68
72469860|NCT03784820|144463579|SUPERIORITY||LS mean difference|-0.27||||0.91|TWO_SIDED|95.0|-5.02|4.47||Comparison of Patients at Post (T2)|Mixed Models Analysis|||||4.47|-5.02|0.91
72469861|NCT03784820|144463579|SUPERIORITY||LS mean difference|4.73||||0.07|TWO_SIDED|95.0|-0.36|9.81||Comparison of Patients at 3 Month Fup (T3)|Mixed Models Analysis|||||9.81|-0.36|0.07
72469862|NCT03784820|144463579|SUPERIORITY||LS mean difference|1.75||||0.65|TWO_SIDED|95.0|-5.73|9.23||Comparison of Patients at 6 Month Fup (T4)|Mixed Models Analysis|||||9.23|-5.73|0.65
72469863|NCT03784820|144463579|SUPERIORITY||LS mean difference|-2.05||||0.52|TWO_SIDED|95.0|-8.21|4.12|||Mixed Models Analysis|||Comparison of Partners at Post (T2)||4.12|-8.21|0.52
72469864|NCT03784820|144463579|SUPERIORITY||LS mean difference|-6.62||||0.07|TWO_SIDED|95.0|-13.74|0.51||Comparison of Partners at 3 Month Fup (T3)|Mixed Models Analysis|||||0.51|-13.74|0.07
72619547|NCT03537729|144769952|SUPERIORITY|Power was based on planned 12 sites and effect size Cohen's d=0.42 for pairwise differences between arms, intraclass correlation coefficient of 0.0012, and reduction in variance due to adjustment for baseline and repeated measures with correlation of 0.4 between pairs of measures. The sample size requirement was 38 per group, or 114 total for power of .80 in two-sided tests at .05 level of significance.|Mean Difference (Final Values)|-0.16|STANDARD_ERROR_OF_MEAN|0.11||0.17|TWO_SIDED|95.0|-0.38|0.07||P-value was not adjusted for multiple comparisons. A priori threshold for statistical significance was .05.|Mixed Models Analysis|Covariates included baseline value of the outcome, age, sex, and cognition score at baseline, and use of wheelchair on the route.|Spaced retrieval minus cues only.|The null hypothesis was that means of two arms on the moderate complexity route are equal, the alternative was that means were not equal.||0.07|-0.38|.17
72622403|NCT03131479|144774710|EQUIVALENCE|Change from baseline was analyzed using a repeated measures model which included diabetic status, renal function, day and renal function\*day and diabetic status\*day as fixed factors and age, baseline body weight and baseline fasting plasma glucose as covariates.|adjusted arithmetic mean difference|-6.05||||0.343|TWO_SIDED|90.0|-16.65|4.55|||Regression, Logistic|||||4.55|-16.65|0.343
72449328|NCT04800211|144416702|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Whole Blood WBC (x 10\^3/uL) in Test2 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood WBC (x 10\^3/uL) in Test2 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-0.846|||<|0.0001|TWO_SIDED|95.0|-1.185|-0.507|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Whole Blood WBC (x 10\^3/uL) in Test2 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood WBC (x 10\^3/uL) in Test2 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||-0.507|-1.185|<.0001
72449329|NCT04800211|144416702|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Whole Blood WBC (x 10\^3/uL) in Test 1 + Test 2 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood WBC (x 10\^3/uL) in Test 1 + Test 2 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-0.873|||<|0.0001|TWO_SIDED|95.0|-1.127|-0.619|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Whole Blood WBC (x 10\^3/uL) in Test 1 + Test 2 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood WBC (x 10\^3/uL) in Test 1 + Test 2 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||-0.619|-1.127|<.0001
72449330|NCT04800211|144416702|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Whole Blood WBC (x 10\^3/uL) in Control is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood WBC (x 10\^3/uL) in Control is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|0.247||||0.2525|TWO_SIDED|95.0|-0.178|0.671|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Whole Blood WBC (x 10\^3/uL) in Control is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood WBC (x 10\^3/uL) in Control is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||0.671|-0.178|0.2525
72449331|NCT04800211|144416702|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Whole Blood WBC (x 10\^3/uL) in Control is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood WBC (x 10\^3/uL) in Control is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|0.098||||0.6503|TWO_SIDED|95.0|-0.33|0.527|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Whole Blood WBC (x 10\^3/uL) in Control is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood WBC (x 10\^3/uL) in Control is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||0.527|-0.330|0.6503
72449332|NCT04800211|144416702|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Whole Blood WBC (x 10\^3/uL) in Control is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood WBC (x 10\^3/uL) in Control is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|0.239||||0.1759|TWO_SIDED|95.0|-0.109|0.588|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Whole Blood WBC (x 10\^3/uL) in Control is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood WBC (x 10\^3/uL) in Control is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||0.588|-0.109|0.1759
72469865|NCT03784820|144463579|SUPERIORITY||LS mean difference|-6.64||||0.03|TWO_SIDED|95.0|-12.73|-0.56||Comparison of Partners at 6 Month Fup (T4)|Mixed Models Analysis|||||-0.56|-12.73|0.03
72449333|NCT04800211|144416702|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Whole Blood WBC (x 10\^3/uL) in Test 1 is equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood WBC (x 10\^3/uL) in Test 1 is NOT equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-0.867||||0.0293|TWO_SIDED|95.0|-1.674|-0.06|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Whole Blood WBC (x 10\^3/uL) in Test 1 is equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood WBC (x 10\^3/uL) in Test 1 is NOT equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||-0.060|-1.674|0.0293
72449334|NCT04800211|144416702|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Whole Blood WBC (x 10\^3/uL) in Test 1 is equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood WBC (x 10\^3/uL) in Test 1 is NOT equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-0.876||||0.0362|TWO_SIDED|95.0|-1.714|-0.038|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Whole Blood WBC (x 10\^3/uL) in Test 1 is equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood WBC (x 10\^3/uL) in Test 1 is NOT equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||-0.038|-1.714|0.0362
72449335|NCT04800211|144416702|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Whole Blood WBC (x 10\^3/uL) in Test 1 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood WBC (x 10\^3/uL) in Test 1 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-1.139|||<|0.0001|TWO_SIDED|95.0|-1.809|-0.469|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Whole Blood WBC (x 10\^3/uL) in Test 1 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood WBC (x 10\^3/uL) in Test 1 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||-0.469|-1.809|<.0001
72449336|NCT04800211|144416702|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Whole Blood WBC (x 10\^3/uL) in Test 2 is equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood WBC (x 10\^3/uL) in Test 2 is NOT equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-0.767||||0.0621|TWO_SIDED|95.0|-1.559|0.025|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Whole Blood WBC (x 10\^3/uL) in Test 2 is equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood WBC (x 10\^3/uL) in Test 2 is NOT equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||0.025|-1.559|0.0621
72449337|NCT04800211|144416702|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Whole Blood WBC (x 10\^3/uL) in Test 2 is equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood WBC (x 10\^3/uL) in Test 2 is NOT equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-0.447||||0.5259|TWO_SIDED|95.0|-1.246|0.352|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Whole Blood WBC (x 10\^3/uL) in Test 2 is equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood WBC (x 10\^3/uL) in Test 2 is NOT equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||0.352|-1.246|0.5259
72469866|NCT03784820|144463580|SUPERIORITY||LS mean difference|0.88||||0.9|TWO_SIDED|95.0|-13.43|15.19||Comparison of Patients at Post (T2)|Mixed Models Analysis|||||15.19|-13.43|0.90
72469867|NCT03784820|144463580|SUPERIORITY||LS mean difference|-0.64||||0.95|TWO_SIDED|95.0|-18.95|17.66||Comparison of Patients at 3 Month Fup (T3)|Mixed Models Analysis|||||17.66|-18.95|0.95
72469868|NCT03784820|144463580|SUPERIORITY||LS mean difference|1.37||||0.89|TWO_SIDED|95.0|-17.17|19.9||Comparison of Patients at 6 Month Fup (T4)|Mixed Models Analysis|||||19.90|-17.17|0.89
72469869|NCT03784820|144463580|SUPERIORITY||LS mean difference|5.81||||0.39|TWO_SIDED|95.0|-7.37|18.98|||Mixed Models Analysis|||Comparison of Partners at Post (T2)||18.98|-7.37|0.39
72469870|NCT03784820|144463580|SUPERIORITY||LS mean difference|6.29||||0.36|TWO_SIDED|95.0|-7.26|19.84||Comparison of Partners at 3 Month Fup (T3)|Mixed Models Analysis|||||19.84|-7.26|0.36
72469871|NCT03784820|144463580|SUPERIORITY||LS mean difference|-1.55||||0.87|TWO_SIDED|95.0|-20.0|16.91||Comparison of Partners at 6 Month Fup (T4)|Mixed Models Analysis|||||16.91|-20.00|0.87
72469872|NCT03784820|144463581|SUPERIORITY||LS mean difference|0.27||||0.84|TWO_SIDED|95.0|-2.29|2.83||Comparison of Patients at Post (T2)|Mixed Models Analysis|||||2.83|-2.29|0.84
72619548|NCT03537729|144769952|SUPERIORITY|Power was based on planned 12 sites and effect size Cohen's d=0.42 for pairwise differences between arms, intraclass correlation coefficient of 0.0012, and reduction in variance due to adjustment for baseline and repeated measures with correlation of 0.4 between pairs of measures. The sample size requirement was 38 per group, or 114 total for power of .80 in two-sided tests at .05 level of significance.|Mean Difference (Final Values)|0.06|STANDARD_ERROR_OF_MEAN|0.11||0.58|TWO_SIDED|95.0|-0.16|0.28||P-value was not adjusted for multiple comparisons. A priori threshold for statistical significance was .05.|Mixed Models Analysis|Covariates included baseline value of the outcome, age, sex, and cognition score at baseline, and use of wheelchair on the route.|Cues minus control.|The null hypothesis was that means of two arms on the high complexity route are equal, the alternative was that means were not equal.||0.28|-0.16|.58
72619549|NCT03537729|144769952|SUPERIORITY|Power was based on planned 12 sites and effect size Cohen's d=0.42 for pairwise differences between arms, intraclass correlation coefficient of 0.0012, and reduction in variance due to adjustment for baseline and repeated measures with correlation of 0.4 between pairs of measures. The sample size requirement was 38 per group, or 114 total for power of .80 in two-sided tests at .05 level of significance.|Mean Difference (Final Values)|0.16|STANDARD_ERROR_OF_MEAN|0.11||0.15|TWO_SIDED|95.0|-0.06|0.37||P-value was not adjusted for multiple comparisons. A priori threshold for statistical significance was .05.|Mixed Models Analysis|Covariates included baseline value of the outcome, age, sex, and cognition score at baseline, and use of wheelchair on the route.|Spaced retrieval minus control.|The null hypothesis was that means of two arms on the high complexity route are equal, the alternative was that means were not equal.||0.37|-0.06|.15
72449338|NCT04800211|144416702|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Whole Blood WBC (x 10\^3/uL) in Test 2 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood WBC (x 10\^3/uL) in Test 2 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-1.085|||<|0.0001|TWO_SIDED|95.0|-1.736|-0.435|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Whole Blood WBC (x 10\^3/uL) in Test 2 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood WBC (x 10\^3/uL) in Test 2 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||-0.435|-1.736|<.0001
72449339|NCT04800211|144416702|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Whole Blood WBC (x 10\^3/uL) in Test 1 + Test 2 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood WBC (x 10\^3/uL) in Test 1 + Test 2 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-1.112|||<|0.0001|TWO_SIDED|95.0|-1.532|-0.693|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Whole Blood WBC (x 10\^3/uL) in Test 1 + Test 2 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood WBC (x 10\^3/uL) in Test 1 + Test 2 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||-0.693|-1.532|<.0001
72449340|NCT04800211|144416702|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Whole Blood WBC (x 10\^3/uL) in Test 2 is equal to Test 1 on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood WBC (x 10\^3/uL) in Test 2 is NOT equal to Test 1 on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-0.054||||0.8248|TWO_SIDED|95.0|-0.535|0.427|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Whole Blood WBC (x 10\^3/uL) in Test 2 is equal to Test 1 on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood WBC (x 10\^3/uL) in Test 2 is NOT equal to Test 1 on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||0.427|-0.535|0.8248
72469873|NCT03784820|144463581|SUPERIORITY||LS mean difference|-0.82||||0.57|TWO_SIDED|95.0|-3.66|2.01||Comparison of Patients at 3 Month Fup (T3)|Mixed Models Analysis|||||2.01|-3.66|0.57
72469874|NCT03784820|144463581|SUPERIORITY||LS mean difference|0.6||||0.67|TWO_SIDED|95.0|-2.15|3.35||Comparison of Patients at 6 Month Fup (T4)|Mixed Models Analysis|||||3.35|-2.15|0.67
72469875|NCT03784820|144463581|SUPERIORITY||LS mean difference|0.46||||0.63|TWO_SIDED|95.0|-1.43|2.35||Comparison of Partners at Post (T2)|Mixed Models Analysis|||||2.35|-1.43|0.63
72469876|NCT03784820|144463581|SUPERIORITY||LS mean difference|1.44||||0.21|TWO_SIDED|95.0|-0.82|3.7||Comparison of Partners at 3 Month Fup (T3)|Mixed Models Analysis|||||3.70|-0.82|0.21
72469877|NCT03784820|144463581|SUPERIORITY||LS mean difference|1.07||||0.34|TWO_SIDED|95.0|-1.14|3.28||Comparison of Partners at 6 Month Fup (T4)|Mixed Models Analysis|||||3.28|-1.14|0.34
72469878|NCT03784820|144463582|SUPERIORITY||LS mean difference|-3.42||||0.5|TWO_SIDED|95.0|-13.36|6.52||Demand/Withdraw score: Comparison of Patients at Post (T2)|Mixed Models Analysis|||||6.52|-13.36|0.50
72469879|NCT03784820|144463582|SUPERIORITY||LS mean difference|-0.47||||0.89|TWO_SIDED|95.0|-7.49|6.54||Demand/Withdraw Score: Comparison of Patients at 3 Month Fup (T3)|Mixed Models Analysis|||||6.54|-7.49|0.89
72469880|NCT03784820|144463582|SUPERIORITY||LS mean difference|-0.63||||0.86|TWO_SIDED|95.0|-7.56|6.3||Demand/Withdraw Score: Comparison of Patients at 6 Month Fup (T4)|Mixed Models Analysis|||||6.30|-7.56|0.86
72469881|NCT03784820|144463582|SUPERIORITY||LS mean difference|2.55||||0.25|TWO_SIDED|95.0|-1.83|6.93||Constructive Communication Score: Comparison of Patients at Post (T2)|Mixed Models Analysis|||||6.93|-1.83|0.25
72619550|NCT03537729|144769952|SUPERIORITY|Power was based on planned 12 sites and effect size Cohen's d=0.42 for pairwise differences between arms, intraclass correlation coefficient of 0.0012, and reduction in variance due to adjustment for baseline and repeated measures with correlation of 0.4 between pairs of measures. The sample size requirement was 38 per group, or 114 total for power of .80 in two-sided tests at .05 level of significance.|Mean Difference (Final Values)|0.09|STANDARD_ERROR_OF_MEAN|0.1||0.37|TWO_SIDED|95.0|-0.11|0.29||P-value was not adjusted for multiple comparisons. A priori threshold for statistical significance was .05.|Mixed Models Analysis|Covariates included baseline value of the outcome, age, sex, and cognition score at baseline, and use of wheelchair on the route.|Spaced retrieval minus cues only.|The null hypothesis was that means of two arms on the high complexity route are equal, the alternative was that means were not equal.||0.29|-0.11|.37
72619551|NCT03537729|144769953|SUPERIORITY|Sample size was determined by power analysis for the adjusted wayfinding speed.|Mean Difference (Final Values)|-0.04|STANDARD_ERROR_OF_MEAN|0.02||0.04|TWO_SIDED|95.0|-0.07|-0.01||P-value was not adjusted for multiple comparisons. A priori threshold for statistical significance was .05.|Mixed Models Analysis|Covariates included baseline value of the outcome, age, sex, and cognition score at baseline, and use of wheelchair on the route.|Cues minus control.|The null hypothesis was that means of two arms on the low complexity route are equal, the alternative was that means were not equal.||-0.01|-0.07|.04
72619552|NCT03537729|144769953|SUPERIORITY|Sample size was determined by power analysis for the adjusted wayfinding speed.|Mean Difference (Final Values)|-0.03|STANDARD_ERROR_OF_MEAN|0.02||0.1|TWO_SIDED|95.0|-0.07|0.01||P-value was not adjusted for multiple comparisons. A priori threshold for statistical significance was .05.|Mixed Models Analysis|Covariates included baseline value of the outcome, age, sex, and cognition score at baseline, and use of wheelchair on the route.|Spaced retrieval minus control.|The null hypothesis was that means of two arms on the low complexity route are equal, the alternative was that means were not equal.||0.01|-0.07|.10
72619553|NCT03537729|144769953|SUPERIORITY|Sample size was determined by power analysis for the adjusted wayfinding speed.|Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.02||0.69|TWO_SIDED|95.0|-0.03|0.04||P-value was not adjusted for multiple comparisons. A priori threshold for statistical significance was .05.|Mixed Models Analysis|Covariates included baseline value of the outcome, age, sex, and cognition score at baseline, and use of wheelchair on the route.|Spaced retrieval minus cues only.|The null hypothesis was that means of two arms on the low complexity route are equal, the alternative was that means were not equal.||0.04|-0.03|.69
72619554|NCT03537729|144769954|SUPERIORITY|Sample size was determined by power analysis for the adjusted wayfinding speed.|Ratio of mean proportions of errors|0.65||||0.04|TWO_SIDED|95.0|0.44|0.99||P-value was not adjusted for multiple comparisons. A priori threshold for statistical significance was .05.|Generalized mixed model analysis|Covariates included baseline value of the outcome, age, sex, and cognition score at baseline, and use of wheelchair on the route.|Ratio of mean proportion of errors for cues divided by proportion of errors for control. Log of the mean was estimated from generalized linear mixed effects models for each arm. The difference between logs of means for two arms was exponentiated.|The null hypothesis was that means of two arms on the moderate complexity route are equal, the alternative was that means were not equal.||0.99|0.44|0.04
72619555|NCT03537729|144769954|SUPERIORITY|Sample size was determined by power analysis for the adjusted wayfinding speed.|Ratio of mean proportions of errors|0.59||||0.01|TWO_SIDED|95.0|0.39|0.9||P-value was not adjusted for multiple comparisons. A priori threshold for statistical significance was .05.|Generalized mixed model analysis|Covariates included baseline value of the outcome, age, sex, and cognition score at baseline, and use of wheelchair on the route.|Ratio of mean proportion of errors for spaced retrieval divided by proportion of errors for control. Log of the mean was estimated from generalized linear mixed effects models for each arm. The difference between logs of means was exponentiated.|The null hypothesis was that means of two arms on the moderate complexity route are equal, the alternative was that means were not equal.||0.90|0.39|.01
72449341|NCT04800211|144416703|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 is equal to zero on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 is NOT equal to zero on Visit 5 (Week 6). (mITT Population)|Mean Difference (Net)|2.821||||0.0002|TWO_SIDED|95.0|1.369|4.273|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 is equal to zero on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 is NOT equal to zero on Visit 5 (Week 6). (mITT Population)||4.273|1.369|0.0002
72449342|NCT04800211|144416703|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 is NOT equal to zero on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|3.468|||<|0.0001|TWO_SIDED|95.0|1.85|5.086|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 is NOT equal to zero on Visit 7 (Week 12). (mITT Population)||5.086|1.850|<.0001
72469523|NCT00781937|144462831|SUPERIORITY_OR_OTHER||Treatment Contrast|-6.06|||<|0.0001||95.0|-7.5|-4.62||Two sided, conducted at a 5% significance level|ANCOVA|The analysis included treatment, gender, country and stratification factor(s) as fixed effects and randomisation value of the endpoint as covariate.||The 3 co-primary endpoints (Outcome Measures 1, 2 and 3) were ranked (#1, 2, 3) and the hypotheses of equality between liraglutide and placebo for each were tested in a hierarchical manner; i.e. a conclusion of liraglutide superiority for a given co-primary endpoint could be drawn only if all preceding hypotheses of equality in the hierarchy had been rejected.||-4.62|-7.50|<0.0001
72469882|NCT03784820|144463582|SUPERIORITY||LS mean difference|2.05||||0.56|TWO_SIDED|95.0|-4.83|8.92||Constructive Communication Score: Comparison of Patients at 3 Month Fup (T3)|Mixed Models Analysis|||||8.92|-4.83|0.56
72449343|NCT04800211|144416703|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 2 is equal to zero on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 2 is NOT equal to zero on Visit 5 (Week 6). (mITT Population)|Mean Difference (Net)|2.245||||0.0022|TWO_SIDED|95.0|0.812|3.679|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 2 is equal to zero on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 2 is NOT equal to zero on Visit 5 (Week 6). (mITT Population)||3.679|0.812|0.0022
72449344|NCT04800211|144416703|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 2 is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 2 is NOT equal to zero on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|3.329|||<|0.0001|TWO_SIDED|95.0|1.768|4.891|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 2 is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 2 is NOT equal to zero on Visit 7 (Week 12). (mITT Population)||4.891|1.768|<.0001
72449345|NCT04800211|144416703|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 + Test 2 is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 + Test 2 is NOT equal to zero on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|3.399|||<|0.0001|TWO_SIDED|95.0|2.252|4.545|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 + Test 2 is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 + Test 2 is NOT equal to zero on Visit 7 (Week 12). (mITT Population)||4.545|2.252|<.0001
72449346|NCT04800211|144416703|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Control is equal to zero on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Control is NOT equal to zero on Visit 5 (Week 6). (mITT Population)|Mean Difference (Net)|1.25||||0.0761|TWO_SIDED|95.0|-0.132|2.633|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Control is equal to zero on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Control is NOT equal to zero on Visit 5 (Week 6). (mITT Population)||2.633|-0.132|0.0761
72449347|NCT04800211|144416703|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Control is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Control is NOT equal to zero on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|1.778||||0.0211|TWO_SIDED|95.0|0.269|3.286|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Control is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Control is NOT equal to zero on Visit 7 (Week 12). (mITT Population)||3.286|0.269|0.0211
72449348|NCT04800211|144416703|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 is equal to Control on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 is NOT equal to Control on Visit 5 (Week 6). (mITT Population)|Mean Difference (Net)|1.57||||0.3841|TWO_SIDED|95.0|-0.951|4.092|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 is equal to Control on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 is NOT equal to Control on Visit 5 (Week 6). (mITT Population)||4.092|-0.951|0.3841
72469883|NCT03784820|144463582|SUPERIORITY||LS mean difference|3.13||||0.34|TWO_SIDED|95.0|-3.27|9.54||Constructive Communication Score: Comparison of Patients at 6 Month Fup (T4)|Mixed Models Analysis|||||9.54|-3.27|0.34
72469884|NCT03784820|144463582|SUPERIORITY||LS mean difference|-10.24||||0.02|TWO_SIDED|95.0|-19.05|-1.42||Demand/Withdraw score: Comparison of Partners at Post (T2)|Mixed Models Analysis|||||-1.42|-19.05|0.02
72469885|NCT03784820|144463582|SUPERIORITY||LS mean difference|-0.12||||0.98|TWO_SIDED|95.0|-8.18|7.95||Demand/Withdraw score: Comparison of Partners at 3 Month Fup (T3)|Mixed Models Analysis|||||7.95|-8.18|0.98
72469886|NCT03784820|144463582|SUPERIORITY||LS mean difference|-2.2||||0.59|TWO_SIDED|95.0|-10.1|5.7||Demand/Withdraw score: Comparison of Partners at 6 Month Fup (T4)|Mixed Models Analysis|||||5.70|-10.10|0.59
72469887|NCT03784820|144463582|SUPERIORITY||LS mean difference|2.41||||0.16|TWO_SIDED|95.0|-0.99|5.82||Constructive Communication Score: Comparison of Partners at Post (T2)|Mixed Models Analysis|||||5.82|-0.99|0.16
72469888|NCT03784820|144463582|SUPERIORITY||LS mean difference|3.94||||0.12|TWO_SIDED|95.0|-1.05|8.93||Constructive Communication Score: Comparison of Partners at 3 Month Fup (T3)|Mixed Models Analysis|||||8.93|-1.05|0.12
72469889|NCT03784820|144463582|SUPERIORITY||LS mean difference|2.26||||0.34|TWO_SIDED|95.0|-2.35|6.87||Constructive Communication Score: Comparison of Partners at 6 Month Fup (T4)|Mixed Models Analysis|||||6.87|-2.35|0.34
72370203|NCT02910986|144250953|SUPERIORITY||||||>|0.05||||||The priori threshold for statistical significance was 0.05.|Chi-squared|||||||> 0.05
72498782|NCT00630331|144527828|SUPERIORITY_OR_OTHER_LEGACY||Vaccine Efficacy|100.0||||0.033|ONE_SIDED|97.5|33.9|||Adjusted p-values are from score statistic with Sidak correction testing the null hypothesis that the VE of IVV vs. placebo is \<= 40% (the relative risk, \>= 0.60). If adjusted p-value is \<0.025, then the comparison is statistically significant.|Sidak-corrected score CI|||"Vaccine efficacy (VE) of IVV vaccine vs. Placebo for A/H1N1 strain~Simultaneous one-sided 97.5% confidence interval (CI) for the VE of IVV vaccine relative to Placebo was based on the Sidak-corrected score CIs for the two relative risks."|||33.9|0.033
72498783|NCT00630331|144527828|SUPERIORITY_OR_OTHER_LEGACY||Vaccine Efficacy|73.6||||0.265|ONE_SIDED|97.5|-30.0|||Adjusted p-values are from score statistic with Sidak correction testing the null hypothesis that the VE of IVV vs. placebo is \<= 40% (the relative risk, \>= 0.60). If adjusted p-value is \<0.025, then the comparison is statistically significant.|Sidak-corrected score CI|||"Vaccine efficacy (VE) of IVV vaccine vs. Placebo for A/H3N2 strain~Simultaneous one-sided 97.5% confidence interval (CI) for the VE of IVV vaccine relative to Placebo was based on the Sidak-corrected score CIs for the two relative risks."|||-30.0|0.265
72498784|NCT00630331|144527828|SUPERIORITY_OR_OTHER_LEGACY||Vaccine Efficacy|51.7||||0.319|ONE_SIDED|97.5|19.4|||Adjusted p-values are from score statistic with Sidak correction testing the null hypothesis that the VE of IVV vs. placebo is \<= 40% (the relative risk, \>= 0.60). If adjusted p-value is \<0.025, then the comparison is statistically significant.|Sidak-corrected score CI|||"Vaccine efficacy (VE) of IVV vaccine vs. Placebo for B strain~Simultaneous one-sided 97.5% confidence interval (CI) for the VE of IVV vaccine relative to Placebo was based on the Sidak-corrected score CIs for the two relative risks."|||19.4|0.319
72498785|NCT00630331|144527829|SUPERIORITY_OR_OTHER_LEGACY||Vaccine Efficacy|69.5|||<|0.001|ONE_SIDED|97.5|55.0|||Adjusted p-values are from score statistic with Sidak correction testing the null hypothesis that the VE of CCI vs. placebo is \<= 40% (the relative risk, \>= 0.60). If adjusted p-value is \<0.025, then the comparison is statistically significant.|Sidak-corrected score CI|||"Vaccine efficacy (VE) of CCI vaccine vs. Placebo (Overall)~Simultaneous one-sided 97.5% confidence interval (CI) for the VE of CCI vaccine relative to Placebo was based on the Sidak-corrected score CIs for the two relative risks."|||55.0|<0.001
72498786|NCT00630331|144527829|SUPERIORITY_OR_OTHER_LEGACY||Vaccine Efficacy|89.3|||<|0.001|ONE_SIDED|97.5|73.0|||Adjusted p-values are from score statistic with Sidak correction testing the null hypothesis that the VE of CCI vs. placebo is \<= 40% (the relative risk, \>= 0.60). If adjusted p-value is \<0.025, then the comparison is statistically significant.|Sidak-corrected score CI|||"Vaccine efficacy (VE) of CCI vaccine vs. Placebo for A/H1N1 strain~Simultaneous one-sided 97.5% confidence interval (CI) for the VE of CCI vaccine relative to Placebo was based on the Sidak-corrected score CIs for the two relative risks."|||73.0|<0.001
72498787|NCT00630331|144527829|SUPERIORITY_OR_OTHER_LEGACY||Vaccine Efficacy|75.6||||0.04|ONE_SIDED|97.5|35.1|||Adjusted p-values are from score statistic with Sidak correction testing the null hypothesis that the VE of CCI vs. placebo is \<= 40% (the relative risk, \>= 0.60). If adjusted p-value is \<0.025, then the comparison is statistically significant.|Sidak-corrected score CI|||"Vaccine efficacy (VE) of CCI vaccine vs. Placebo for A/H3N2 strain~Simultaneous one-sided 97.5% confidence interval (CI) for the VE of CCI vaccine relative to Placebo was based on the Sidak-corrected score CIs for the two relative risks."|||35.1|0.040
72498788|NCT00630331|144527829|SUPERIORITY_OR_OTHER_LEGACY||Vaccine Efficacy|49.9||||0.37|ONE_SIDED|97.5|18.2|||Adjusted p-values are from score statistic with Sidak correction testing the null hypothesis that the VE of CCI vs. placebo is \<= 40% (the relative risk, \>= 0.60). If adjusted p-value is \<0.025, then the comparison is statistically significant.|Sidak-corrected score CI|||"Vaccine efficacy (VE) of CCI vaccine vs. Placebo for B strain~Simultaneous one-sided 97.5% confidence interval (CI) for the VE of CCI vaccine relative to Placebo was based on the Sidak-corrected score CIs for the two relative risks."|||18.2|0.37
72498789|NCT00630331|144527829|SUPERIORITY_OR_OTHER_LEGACY||Vaccine Efficacy|63.0||||0.003|ONE_SIDED|97.5|46.7|||Adjusted p-values are from score statistic with Sidak correction testing the null hypothesis that the VE of IVV vs. placebo is \<= 40% (the relative risk, \>= 0.60). If adjusted p-value is \<0.025, then the comparison is statistically significant.|Sidak-corrected score CI|||"Vaccine efficacy (VE) of IVV vaccine vs. Placebo (Overall)~Simultaneous one-sided 97.5% confidence interval (CI) for the VE of IVV vaccine relative to Placebo was based on the Sidak-corrected score CIs for the two relative risks."|||46.7|0.003
72561766|NCT01074008|144654157|SUPERIORITY_OR_OTHER|||||||0.009||||||There was no adjustment for multiple comparisons and the pre-specified, two-sided significance level was ≤ 0.05.|ANCOVA|Treatment was the factor and baseline log10 HCV RNA level was the covariate.||Eight participants per ABT-072 and 11 participants in the placebo group would provide 92% power to detect a 1.0 log10 difference with a standard deviation of 0.6 log10 IU/mL and a two-sided, two-sample t-test with a significance level of 0.05.||||0.009
72561767|NCT01074008|144654157|SUPERIORITY_OR_OTHER|||||||0.012||||||There was no adjustment for multiple comparisons and the pre-specified, two-sided significance level was ≤ 0.05.|ANCOVA|Treatment was the factor and baseline log10 HCV RNA level was the covariate.||Eight participants per ABT-072 and 11 participants in the placebo group would provide 92% power to detect a 1.0 log10 difference with a standard deviation of 0.6 log10 IU/mL and a two-sided, two-sample t-test with a significance level of 0.05.||||0.012
72561768|NCT01074008|144654157|SUPERIORITY_OR_OTHER||||||<|0.001||||||There was no adjustment for multiple comparisons and the pre-specified, two-sided significance level was ≤ 0.05.|ANCOVA|Treatment was the factor and baseline log10 HCV RNA level was the covariate.||Eight participants per ABT-072 and 11 participants in the placebo group would provide 92% power to detect a 1.0 log10 difference with a standard deviation of 0.6 log10 IU/mL and a two-sided, two-sample t-test with a significance level of 0.05.||||<0.001
72561769|NCT01074008|144654157|SUPERIORITY_OR_OTHER|||||||0.032||||||There was no adjustment for multiple comparisons and the pre-specified, 2-sided significance level was ≤ 0.05.|ANCOVA|Treatment was the factor and baseline log10 HCV RNA level was the covariate.||Eight subjects per ABT-333 group and 11 subjects in the placebo group would provide 82% power to detect a 1.0 log10 IU/mL difference with a standard deviation of 0.7 log10 IU/mL and a 2-sided 2-sample t-test with a significance level of 0.05.||||0.032
72370204|NCT02910986|144250953|OTHER||difference between EC and UC|2.6|||||TWO_SIDED|98.3|-6.0|11.2||||||||11.2|-6.0|
72370205|NCT02910986|144250953|OTHER||difference between INT and UC|5.0|||||TWO_SIDED|98.3|-4.3|14.3||||||||14.3|-4.3|
72370206|NCT02910986|144250953|OTHER||difference between INT and ENH|2.4|||||TWO_SIDED|98.3|-7.0|11.9||||||||11.9|-7.0|
72449349|NCT04800211|144416703|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|1.69||||0.3934|TWO_SIDED|95.0|-1.084|4.464|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)||4.464|-1.084|0.3934
72449350|NCT04800211|144416703|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 2 is equal to Control on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 2 is NOT equal to Control on Visit 5 (Week 6). (mITT Population)|Mean Difference (Net)|0.995||||0.7782|TWO_SIDED|95.0|-1.505|3.494|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 2 is equal to Control on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 2 is NOT equal to Control on Visit 5 (Week 6). (mITT Population)||3.494|-1.505|0.7782
72619556|NCT03537729|144769954|SUPERIORITY|Sample size was determined by power analysis for the adjusted wayfinding speed.|Ratio of mean proportions of errors|0.9||||0.61|TWO_SIDED|95.0|0.6|1.35||P-value was not adjusted for multiple comparisons. A priori threshold for statistical significance was .05.|Generalized mixed model analysis|Covariates included baseline value of the outcome, age, sex, and cognition score at baseline, and use of wheelchair on the route.|Ratio of mean proportion of errors for spaced retrieval divided by proportion of errors for cues. Log of the mean was estimated from generalized linear mixed effects models for each arm. The difference between logs of means was exponentiated.|The null hypothesis was that means of two arms on the moderate complexity route are equal, the alternative was that means were not equal.||1.35|0.60|.61
72449351|NCT04800211|144416703|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|1.552||||0.4576|TWO_SIDED|95.0|-1.171|4.274|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)||4.274|-1.171|0.4576
72449352|NCT04800211|144416703|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 + Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 + Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|1.621||||0.0849|TWO_SIDED|95.0|-0.224|3.466|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 + Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 + Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)||3.466|-0.224|0.0849
72449353|NCT04800211|144416703|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 is equal to Test 2 on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 is NOT equal to Test 2 on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|0.139||||0.9016|TWO_SIDED|95.0|-2.064|2.341|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 is equal to Test 2 on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 is NOT equal to Test 2 on Visit 7 (Week 12). (mITT Population)||2.341|-2.064|0.9016
72469890|NCT03784820|144463583|SUPERIORITY||LS mean difference|0.09||||0.7|TWO_SIDED|95.0|-0.35|0.53||Comparison of Patients at Post (T2)|Mixed Models Analysis|||||0.53|-0.35|0.70
72469891|NCT03784820|144463583|SUPERIORITY||LS mean difference|-0.03||||0.9|TWO_SIDED|95.0|-0.48|0.42||Comparison of Patients at 3 Month Fup (T3)|Mixed Models Analysis|||||0.42|-0.48|0.90
72469892|NCT03784820|144463583|SUPERIORITY||LS mean difference|0.25||||0.38|TWO_SIDED|95.0|-0.31|0.82||Comparison of Patients at 6 Month Fup (T4)|Mixed Models Analysis|||||0.82|-0.31|0.38
72469893|NCT03784820|144463584|SUPERIORITY||LS mean difference|-0.33||||0.89|TWO_SIDED|95.0|-5.1|4.43||Comparison of Patients at Post (T2)|Mixed Models Analysis|||||4.43|-5.10|0.89
72449354|NCT04800211|144416704|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Serum HDL-C (mg/dL) in Test 1 is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|5.587||||0.0004|TWO_SIDED|95.0|2.511|8.662|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Serum HDL-C (mg/dL) in Test 1 is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||8.662|2.511|0.0004
72449355|NCT04800211|144416704|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Serum HDL-C (mg/dL) in Test 1 is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|2.556||||0.1141|TWO_SIDED|95.0|-0.62|5.732|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Serum HDL-C (mg/dL) in Test 1 is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||5.732|-0.620|0.1141
72449356|NCT04800211|144416704|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Serum HDL-C (mg/dL) in Test 1 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|5.536||||0.0007|TWO_SIDED|95.0|2.367|8.705|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Serum HDL-C (mg/dL) in Test 1 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||8.705|2.367|0.0007
72469524|NCT00781937|144462832|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.82|||<|0.0001||95.0|3.01|7.71||Two sided, conducted at a 5% significance level|Regression, Logistic|The analysis included treatment, gender, country, and stratification factor(s) as fixed effects and randomisation value of endpoint as covariate.||The 3 co-primary endpoints (Outcome Measures 1, 2 and 3) were ranked (#1, 2, 3) and the hypotheses of equality between liraglutide and placebo for each were tested in a hierarchical manner; i.e. a conclusion of liraglutide superiority for a given co-primary endpoint could be drawn only if all preceding hypotheses of equality in the hierarchy had been rejected.||7.71|3.01|<0.0001
72469894|NCT03784820|144463584|SUPERIORITY||LS mean difference|0.45||||0.85|TWO_SIDED|95.0|-4.14|5.04||Comparison of Patients at 3 Month Fup (T3)|Mixed Models Analysis|||||5.04|-4.14|0.85
72469895|NCT03784820|144463584|SUPERIORITY||LS mean difference|-0.85||||0.72|TWO_SIDED|95.0|-5.54|3.85||Comparison of Patients at 6 Month Fup (T4)|Mixed Models Analysis|||||3.85|-5.54|0.72
72469896|NCT03784820|144463584|SUPERIORITY||LS mean difference|-3.05||||0.29|TWO_SIDED|95.0|-8.73|2.63||Comparison of Partners at Post (T2)|Mixed Models Analysis|||||2.63|-8.73|0.29
72469897|NCT03784820|144463584|SUPERIORITY||LS mean difference|-4.69||||0.08|TWO_SIDED|95.0|-9.9|0.51||Comparison of Partners at 3 Month Fup (T3)|Mixed Models Analysis|||||0.51|-9.90|0.08
72469898|NCT03784820|144463584|SUPERIORITY||LS mean difference|-3.29||||0.19|TWO_SIDED|95.0|-8.23|1.65||Comparison of Partners at 6 Month Fup (T4)|Mixed Models Analysis|||||1.65|-8.23|0.19
72469899|NCT03784820|144463585|SUPERIORITY||LS mean difference|-1.2||||0.41|TWO_SIDED|95.0|-4.08|1.67||Comparison of Patients at Post (T2)|Mixed Models Analysis|||||1.67|-4.08|0.41
72469900|NCT03784820|144463585|SUPERIORITY||LS mean difference|0.33||||0.84|TWO_SIDED|95.0|-2.87|3.54||Comparison of Patients at 3 Month Fup (T3)|Mixed Models Analysis|||||3.54|-2.87|0.84
72469901|NCT03784820|144463585|SUPERIORITY||LS mean difference|-1.21||||0.5|TWO_SIDED|95.0|-4.76|2.34||Comparison of Patients at 6 Month Fup (T4)|Mixed Models Analysis|||||2.34|-4.76|0.50
72469902|NCT03784820|144463585|SUPERIORITY||LS mean difference|-1.09||||0.52|TWO_SIDED|95.0|-4.43|2.24||Comparison of Partners at Post (T2)|Mixed Models Analysis|||||2.24|-4.43|0.52
72469903|NCT03784820|144463585|SUPERIORITY||LS mean difference|-1.38||||0.3|TWO_SIDED|95.0|-3.96|1.21||Comparison of Partners at 3 Month Fup (T3)|Mixed Models Analysis|||||1.21|-3.96|0.30
72469904|NCT03784820|144463585|SUPERIORITY||LS mean difference|-2.52||||0.03|TWO_SIDED|95.0|-4.78|-0.25||Comparison of Partners at 6 Month Fup (T4)|Mixed Models Analysis|||||-0.25|-4.78|0.03
72469905|NCT03784820|144463586|SUPERIORITY||Mean Difference (Final Values)|0.53||||0.79|TWO_SIDED|95.0|-3.66|4.72||Comparison of Patients at Post (T2)|t-test, 2 sided|||||4.72|-3.66|0.79
72469906|NCT00658606|144463591|SUPERIORITY_OR_OTHER|||||||0.032||95.0||||No adjustments were made for multiple comparisons.|Fisher Exact|||||||0.032
72449357|NCT04800211|144416704|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Serum HDL-C (mg/dL) in Test 2 is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 2 is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|6.629|||<|0.0001|TWO_SIDED|95.0|3.68|9.577|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Serum HDL-C (mg/dL) in Test 2 is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 2 is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||9.577|3.680|<.0001
72449358|NCT04800211|144416704|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Serum HDL-C (mg/dL) in Test 2 is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 2 is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|4.083||||0.0072|TWO_SIDED|95.0|1.118|7.047|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Serum HDL-C (mg/dL) in Test 2 is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 2 is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||7.047|1.118|0.0072
72449359|NCT04800211|144416704|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Serum HDL-C (mg/dL) in Test2 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test2 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|4.688||||0.0023|TWO_SIDED|95.0|1.691|7.686|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Serum HDL-C (mg/dL) in Test2 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test2 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||7.686|1.691|0.0023
72469907|NCT00658606|144463592|SUPERIORITY_OR_OTHER|||||||0.037||95.0||||No adjustments were made to multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.037
72469908|NCT00658606|144463593|SUPERIORITY_OR_OTHER|||||||0.001||95.0||||No adjustments were made for multiple comparisons.|Wilcoxon (Mann-Whitney)|||Statistical Analysis applies to 'Change from Baseline'||||0.001
72469909|NCT00658606|144463594|SUPERIORITY_OR_OTHER|||||||0.382||95.0||||Results were adjusted for use of concomitant psoriasis treatment.|ANOVA|||Statistical Analysis applies to 'Change from Baseline'||||0.382
72469910|NCT00658606|144463595|SUPERIORITY_OR_OTHER|||||||0.052||95.0||||No adjustments were made for multiple comparisons.|Fisher Exact|||Statistical Analysis applies to 'Clear or Almost Clear = Yes'||||0.052
72469911|NCT00658606|144463596|SUPERIORITY_OR_OTHER|||||||0.026||95.0||||No adjustments were made for multiple comparisons.|Fisher Exact|||Statistical Analysis applies to 'Clear or Almost Clear = Yes'||||0.026
72469912|NCT00658606|144463597|SUPERIORITY_OR_OTHER|||||||0.147||95.0||||No adjustments were made for multiple comparisons.|Fisher Exact|||Statistical Analysis applies to 'PASI 90 = Yes'||||0.147
72469913|NCT00658606|144463598|SUPERIORITY_OR_OTHER|||||||0.566||95.0||||No adjustments were made for multiple comparisons.|Log Rank|||||||0.566
72469914|NCT00658606|144463599|SUPERIORITY_OR_OTHER|||||||0.001||95.0||||No adjustments were made for multiple comparisons.|Log Rank|||||||0.001
72469915|NCT00658606|144463600|SUPERIORITY_OR_OTHER|||||||0.007||95.0||||No adjustments were made for multiple comparisons.|Log Rank|||||||0.007
72469916|NCT00658606|144463601|SUPERIORITY_OR_OTHER|||||||0.539||95.0||||Results were adjusted for use of concomitant psoriasis treatment.|ANOVA|||Statistical Analysis applies to 'Change from Baseline'||||0.539
72469917|NCT06314438|144463603|EQUIVALENCE|paired samples t test with significance set at 0.05 p value||||||0.34|||||||t-test, 2 sided|||||||0.34
72469918|NCT06314438|144463604|EQUIVALENCE|paired samples t test with significance level at 0.05||||||0.05|||||||t-test, 2 sided|||||||0.05
72469919|NCT06314438|144463605|EQUIVALENCE|paired samples t test with significance set at 0.05 p value|||||<|0.01|||||||t-test, 2 sided|||||||<0.01
72469920|NCT03170518|144463613|SUPERIORITY|Imputed datasets were analyzed using analysis of covariance (ANCOVA) with terms for treatment, stratification factors (antihyperglycemic agent background and age group), and baseline HbA1c.|Least square mean difference|-0.76|||=|0.002|TWO_SIDED|95.0|-1.25|-0.27|||ANCOVA|||||-0.27|-1.25|= 0.002
72469921|NCT03023423|144463668|SUPERIORITY||Odds Ratio (OR)|0.3|||||TWO_SIDED|95.0|0.03|1.92||||||||1.92|0.03|
72469922|NCT03358238|144463683|OTHER||Proportion|0.404|||||TWO_SIDED|95.0|0.264|0.557|||||Type of confidence interval = Clopper-Pearson|||0.557|0.264|
72469923|NCT03358238|144463684|SUPERIORITY||Difference in Average Proportions|0.0017||||0.99|TWO_SIDED|95.0|-0.1774|0.1807||Statistical significance was an alpha level of 0.05.|t-test, 2 sided|Two-sample t test. Degrees of freedom = 45.|Two-sample t confidence intervals|Null hypothesis was that the difference in average adherence rates of self-reporting between arms was zero.||0.1807|-0.1774|0.99
72469924|NCT03358238|144463685|SUPERIORITY||Risk Difference (RD)|-0.0189||||0.85|TWO_SIDED|95.0|-0.2215|0.1837||Statistical significance was considered an alpha level of 0.05.|t-test, 2 sided|Two-sample t-test. Degrees of freedom = 45|Two-sample t confidence intervals|Null hypothesis was that the difference in average adherence rates to activity tracking between arms was zero.||0.1837|-0.2215|0.85
72449360|NCT04800211|144416704|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Serum HDL-C (mg/dL) in Test 1 + Test 2 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 + Test 2 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|5.112|||<|0.0001|TWO_SIDED|95.0|2.874|7.35|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Serum HDL-C (mg/dL) in Test 1 + Test 2 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 + Test 2 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||7.350|2.874|<.0001
72449361|NCT04800211|144416704|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Serum HDL-C (mg/dL) in Control is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Control is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|0.777||||0.603|TWO_SIDED|95.0|-2.165|3.72|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Serum HDL-C (mg/dL) in Control is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Control is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||3.720|-2.165|0.6030
72449362|NCT04800211|144416704|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Serum HDL-C (mg/dL) in Control is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Control is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|1.003||||0.5053|TWO_SIDED|95.0|-1.96|3.967|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Serum HDL-C (mg/dL) in Control is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Control is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||3.967|-1.960|0.5053
72469525|NCT00781937|144462833|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.86|||<|0.0001||95.0|2.44|6.09||Two sided, conducted at a 5% significance level|Regression, Logistic|The analysis included treatment, gender, country, and stratification factor(s) as fixed effects and randomisation value of endpoint as covariate.||The 3 co-primary endpoints (Outcome Measures 1, 2 and 3) were ranked (#1, 2, 3) and the hypotheses of equality between liraglutide and placebo for each were tested in a hierarchical manner; i.e. a conclusion of liraglutide superiority for a given co-primary endpoint could be drawn only if all preceding hypotheses of equality in the hierarchy had been rejected.||6.09|2.44|<0.0001
72469925|NCT03358238|144463686|OTHER||Proportion|0.5385|||||TWO_SIDED|95.0|0.3718|0.6991|||||Type of confidence interval = Clopper-Pearson|Estimating proportion of individuals with higher adherence rates for self-report over activity tracking among individuals with unequal adherence rates||0.6991|0.3718|
72469926|NCT03358238|144463686|SUPERIORITY|||||||0.0828|||||||Chi-squared|Degrees of freedom = 1||Null hypothesis is that among individuals with unequal adherence rates, the proportion of individuals with greater adherence to self-report over activity tracking in the Review Arm is equal to the proportion of individuals with greater adherence to self-report over activity tracking in the No Review Arm.||||0.0828
72469927|NCT03358238|144463687|OTHER||Mean Difference (Net)|0.79||||0.2|TWO_SIDED|95.0|-0.42|1.99||Statistical significance was considered an alpha level of 0.05.|t-test, 2 sided|One-sample t-test. Degrees of freedom = 46.|"One participant had a single item missing on the Young Mania Rating Scale administered at study start. A zero was imputed for the missing item to recover a total score.~One-sample t confidence intervals."|"One participant had a single item missing on the Young Mania Rating Scale administered at study start. A zero was imputed for the missing item to recover a total score.~Null hypothesis was that the average change in total scores was zero."||1.99|-0.42|0.20
72469928|NCT03358238|144463688|OTHER||Mean Difference (Net)|0.89||||0.32|TWO_SIDED|95.0|-0.91|2.7||Statistical significance was considered an alpha level of 0.05.|t-test, 2 sided|One-sample t test. Degrees of freedom = 46|One-sample t confidence intervals|Null hypothesis was that average change in scores on the structured interview guide for the Hamilton rating scale for depression is zero.||2.70|-0.91|0.32
72561770|NCT01074008|144654157|SUPERIORITY_OR_OTHER|||||||0.053||||||There was no adjustment for multiple comparisons and the pre-specified, two-sided significance level was ≤ 0.05.|ANCOVA|Treatment was the factor and baseline log10 HCV RNA level was the covariate.||Eight participants per ABT-333 group and 11 participants in the placebo group would provide 82% power to detect a 1.0 log10 IU/mL difference with a standard deviation of 0.7 log10 IU/mL and a two-sided, two-sample t-test with a significance level of 0.05.||||0.053
72561771|NCT01074008|144654158|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED|||||There was no adjustment for multiple comparisons and the pre-specified, two-sided significance level was ≤ 0.05.|Fisher Exact|||||||0.001
72469929|NCT01227616|144463689|NON_INFERIORITY|The study protocol defined the margin for non-inferiority as 0.5 g/dL meaning non-inferiority would be established in a TP if the lower limit of the 95% confidence limit for the difference between ferumoxytol and iron sucrose mean change was ≥0.5 g/dL.|Mean Difference (Final Values)|0.5|||<|0.05|TWO_SIDED||||||ANCOVA|Stats. of primary endpoint performed only for TP1 and TP2. 240 subjects retreated should yield 90% power to detect non-inferiority during TP2.||||||<0.05
72469930|NCT03728985|144463714|NON_INFERIORITY|Performance Goal 80%|Absolute Percentage with Success|77.5||||0.5908|TWO_SIDED|90.0|69.6|84.1|||Fisher Exact||The lower estimated confidence interval above the Performance Goal of 80% would be considered success.|||84.1|69.6|0.5908
72449363|NCT04800211|144416704|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Serum HDL-C (mg/dL) in Control is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Control is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|0.674||||0.6607|TWO_SIDED|95.0|-2.347|3.694|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Serum HDL-C (mg/dL) in Control is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Control is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||3.694|-2.347|0.6607
72469526|NCT00781937|144462834|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.3|||<|0.0001||95.0|2.79|10.08||Two sided, conducted at a 5% significance level|Regression, Logistic|The analysis included treatment, gender, country, and stratification factor(s) as fixed effects and randomisation value of endpoint as covariate.||||10.08|2.79|<0.0001
72469527|NCT00781937|144462835|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.09|||<|0.0001||95.0|0.03|0.26||Two sided, conducted at a 5% significance level|Regression, Logistic|The analysis included treatment, gender, country, and stratification factor(s) as fixed effects and randomisation value of endpoint as covariate.||||0.26|0.03|<0.0001
72561772|NCT01074008|144654158|SUPERIORITY_OR_OTHER|||||||0.006|TWO_SIDED|||||There was no adjustment for multiple comparisons and the pre-specified, two-sided significance level was ≤ 0.05.|Fisher Exact|||||||0.006
72561773|NCT01074008|144654158|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||There was no adjustment for multiple comparisons and the pre-specified, two-sided significance level was ≤ 0.05.|Fisher Exact|||||||<0.001
72469528|NCT00781937|144462837|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.86|||<|0.0001||95.0|3.12|10.98||Two sided, conducted at a 5% significance level|Regression, Logistic|The analysis included treatment, gender, country, and stratification factor(s) as fixed effects and randomisation value of endpoint as covariate.||||10.98|3.12|<0.0001
72469529|NCT00781937|144462838|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.02|||<|0.0001||95.0|3.65|9.92||Two sided, conducted at a 5% significance level|Regression, Logistic|The analysis included treatment, gender, country, and stratification factor(s) as fixed effects and randomisation value of endpoint as covariate.||||9.92|3.65|<0.0001
72469530|NCT00781937|144462839|SUPERIORITY_OR_OTHER||Treatment Contrast|-5.86|||<|0.0001||95.0|-7.3|-4.43||Two sided, conducted at a 5% significance level|ANCOVA|The analysis included treatment, gender, country and stratification factor(s) as fixed effects and randomisation value of the endpoint as covariate.||||-4.43|-7.30|<0.0001
72469531|NCT00781937|144462840|SUPERIORITY_OR_OTHER||Treatment Contrast|-4.23|||<|0.0001||95.0|-6.04|-2.43||Two sided, conducted at a 5% significance level|ANCOVA|The analysis included treatment, gender, country and stratification factor(s) as fixed effects and randomisation value of the endpoint as covariate.||||-2.43|-6.04|<0.0001
72370207|NCT04380519|144250954|SUPERIORITY||Risk Ratio (RR)|1.012||||0.434|ONE_SIDED|97.5|0.88|||Hochberg adjustment was applied for p-values|Maximal Likelihood Estimator (MLE) model||||||0.880|0.434
72469532|NCT00781937|144462841|SUPERIORITY_OR_OTHER||Treatment Contrast|-2.72||||0.0068||95.0|-4.69|-0.76||Two sided, conducted at a 5% significance level|ANCOVA|The analysis included treatment, gender, country and stratification factor(s) as fixed effects and randomisation value of the endpoint as covariate.||Analysis is of treatment contrast, change in systolic blood pressure.||-0.76|-4.69|0.0068
72469533|NCT00781937|144462841|SUPERIORITY_OR_OTHER||Treatment Contrast|-0.34||||0.6386||95.0|-1.74|1.07||Two sided, conducted at a 5% significance level|ANCOVA|The analysis included treatment, gender, country and stratification factor(s) as fixed effects and randomisation value of the endpoint as covariate.||Analysis is of treatment contrast, change in diastolic blood pressure.||1.07|-1.74|0.6386
72469534|NCT00781937|144462842|SUPERIORITY_OR_OTHER||Treatment Contrast|0.97||||0.1968||95.0|-0.51|2.45||Two sided, conducted at a 5% significance level|ANCOVA|The analysis included treatment, gender, country and stratification factor(s) as fixed effects and randomisation value of the endpoint as covariate.||||2.45|-0.51|0.1968
72469535|NCT00781937|144462843|SUPERIORITY_OR_OTHER||Treatment Contrast|-0.11||||0.031||95.0|-0.2|-0.01||Two sided, conducted at a 5% significance level|ANCOVA|The analysis included treatment, gender, country and stratification factor(s) as fixed effects and randomisation value of the endpoint as covariate.||||-0.01|-0.20|0.0310
72469536|NCT00781937|144462844|SUPERIORITY_OR_OTHER||Treatment Contrast|-0.09||||0.1098||95.0|-0.2|0.02||Two sided, conducted at a 5% significance level|ANCOVA|The analysis included treatment, gender, country and stratification factor(s) as fixed effects and randomisation value of the endpoint as covariate.||||0.02|-0.20|0.1098
72469537|NCT00781937|144462845|SUPERIORITY_OR_OTHER||Treatment Contrast|-0.11||||0.1149||95.0|-0.24|0.03||Two sided, conducted at a 5% significance level|ANCOVA|The analysis included treatment, gender, country and stratification factor(s) as fixed effects and randomisation value of the endpoint as covariate.||||0.03|-0.24|0.1149
72469538|NCT00781937|144462846|SUPERIORITY_OR_OTHER||Treatment Contrast|-13.01||||0.0141||95.0|-23.4|-2.64||Two sided, conducted at a 5% significance level|ANCOVA|The analysis included treatment, gender, country and stratification factor(s) as fixed effects and randomisation value of the endpoint as covariate.||||-2.64|-23.40|0.0141
72469539|NCT00781937|144462847|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.64||||0.1199||95.0|0.36|1.12||Two sided, conducted at a 5% significance level|Regression, Logistic|The analysis included treatment, gender, and stratification factor(s) as fixed effects and metabolic status and weight at baseline as covariates.||||1.12|0.36|0.1199
72469540|NCT00781937|144462848|SUPERIORITY_OR_OTHER||Treatment Contrast|-3.5|||<|0.0001||95.0|-4.84|-2.15||Two sided, conducted at a 5% significance level|ANCOVA|The analysis included treatment, gender, country and stratification factor(s) as fixed effects and randomisation value of the endpoint as covariate.||||-2.15|-4.84|<0.0001
72469541|NCT00781937|144462849|SUPERIORITY_OR_OTHER||Treatment Contrast|-2.05|||<|0.0001||95.0|-2.53|-1.57||Two sided, conducted at a 5% significance level|ANCOVA|The analysis included treatment, gender, country and stratification factor(s) as fixed effects and randomisation value of the endpoint as covariate.||||-1.57|-2.53|<0.0001
72449364|NCT04800211|144416704|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Serum HDL-C (mg/dL) in Test 1 is equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 is NOT equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|4.809||||0.1309|TWO_SIDED|95.0|-0.827|10.446|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Serum HDL-C (mg/dL) in Test 1 is equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 is NOT equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||10.446|-0.827|0.1309
72449365|NCT04800211|144416704|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Serum HDL-C (mg/dL) in Test 1 is equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 is NOT equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|1.553||||0.9776|TWO_SIDED|95.0|-4.212|7.318|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Serum HDL-C (mg/dL) in Test 1 is equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 is NOT equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||7.318|-4.212|0.9776
72449366|NCT04800211|144416704|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Serum HDL-C (mg/dL) in Test 1 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|4.862||||0.1422|TWO_SIDED|95.0|-0.939|10.663|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Serum HDL-C (mg/dL) in Test 1 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||10.663|-0.939|0.1422
72449367|NCT04800211|144416704|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Serum HDL-C (mg/dL) in Test 2 is equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 2 is NOT equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|5.851||||0.0334|TWO_SIDED|95.0|0.307|11.396|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Serum HDL-C (mg/dL) in Test 2 is equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 2 is NOT equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||11.396|0.307|0.0334
72498790|NCT00630331|144527829|SUPERIORITY_OR_OTHER_LEGACY||Vaccine Efficacy|81.5|||<|0.001|ONE_SIDED|97.5|60.9|||Adjusted p-values are from score statistic with Sidak correction testing the null hypothesis that the VE of IVV vs. placebo is \<= 40% (the relative risk, \>= 0.60). If adjusted p-value is \<0.025, then the comparison is statistically significant.|Sidak-corrected score CI|||"Vaccine efficacy (VE) of IVV vaccine vs. Placebo for A/H1N1 strain~Simultaneous one-sided 97.5% confidence interval (CI) for the VE of IVV vaccine relative to Placebo was based on the Sidak-corrected score CIs for the two relative risks."|||60.9|<0.001
72498791|NCT00630331|144527829|SUPERIORITY_OR_OTHER_LEGACY||Vaccine Efficacy|49.3||||0.53|ONE_SIDED|97.5|-9.0|||Adjusted p-values are from score statistic with Sidak correction testing the null hypothesis that the VE of IVV vs. placebo is \<= 40% (the relative risk, \>= 0.60). If adjusted p-value is \<0.025, then the comparison is statistically significant.|Sidak-corrected score CI|||"Vaccine efficacy (VE) of IVV vaccine vs. Placebo for A/H3N2 strain~Simultaneous one-sided 97.5% confidence interval (CI) for the VE of IVV vaccine relative to Placebo was based on the Sidak-corrected score CIs for the two relative risks."|||-9.0|0.53
72498792|NCT00630331|144527829|SUPERIORITY_OR_OTHER_LEGACY||Vaccine Efficacy|53.2||||0.26|ONE_SIDED|97.5|22.2|||Adjusted p-values are from score statistic with Sidak correction testing the null hypothesis that the VE of IVV vs. placebo is \<= 40% (the relative risk, \>= 0.60). If adjusted p-value is \<0.025, then the comparison is statistically significant.|Sidak-corrected score CI|||"Vaccine efficacy (VE) of IVV vaccine vs. Placebo for B strain~Simultaneous one-sided 97.5% confidence interval (CI) for the VE of IVV vaccine relative to Placebo was based on the Sidak-corrected score CIs for the two relative risks."|||22.2|0.26
72561774|NCT01074008|144654158|SUPERIORITY_OR_OTHER|||||||0.262|TWO_SIDED|||||There was no adjustment for multiple comparisons and the pre-specified, two-sided significance level was ≤ 0.05.|Fisher Exact|||||||0.262
72561775|NCT01074008|144654158|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED|||||There was no adjustment for multiple comparisons and the pre-specified, two-sided significance level was ≤ 0.05.|Fisher Exact|||||||1.000
72561776|NCT01074008|144654158|SUPERIORITY_OR_OTHER|||||||0.245|TWO_SIDED|||||There was no adjustment for multiple comparisons and the pre-specified, two-sided significance level was ≤ 0.05.|Fisher Exact|||||||0.245
72561777|NCT01074008|144654158|SUPERIORITY_OR_OTHER|||||||0.111|TWO_SIDED|||||There was no adjustment for multiple comparisons and the pre-specified, two-sided significance level was ≤ 0.05.|Fisher Exact|||||||0.111
72449368|NCT04800211|144416704|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Serum HDL-C (mg/dL) in Test 2 is equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 2 is NOT equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|3.08||||0.5622|TWO_SIDED|95.0|-2.501|8.66|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Serum HDL-C (mg/dL) in Test 2 is equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 2 is NOT equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||8.660|-2.501|0.5622
72449369|NCT04800211|144416704|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Serum HDL-C (mg/dL) in Test 2 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 2 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|4.014||||0.2841|TWO_SIDED|95.0|-1.643|9.672|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Serum HDL-C (mg/dL) in Test 2 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 2 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||9.672|-1.643|0.2841
72449370|NCT04800211|144416704|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Serum HDL-C (mg/dL) in Test 1 + Test 2 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 + Test 2 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|4.438||||0.0178|TWO_SIDED|95.0|0.774|8.103|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Serum HDL-C (mg/dL) in Test 1 + Test 2 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 + Test 2 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||8.103|0.774|0.0178
72449371|NCT04800211|144416704|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Serum HDL-C (mg/dL) in Test 2 is equal to Test 1 on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 2 is NOT equal to Test 1 on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|0.847||||0.6944|TWO_SIDED|95.0|-3.398|5.093|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Serum HDL-C (mg/dL) in Test 2 is equal to Test 1 on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 2 is NOT equal to Test 1 on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||5.093|-3.398|0.6944
72498793|NCT01955707|144527866|SUPERIORITY_OR_OTHER||adjusted mean difference (log-scale)|0.08|||||TWO_SIDED|90.0|-0.09|0.26||||||Treatment contrasts derived from a repeated measures mixed effects model modeling log relative growth relative to baseline using an autoregressive variance-covariance matrix structure. The model adjusts for treatment, time, treatment by time, log baseline DWI volume, treatment time window, and tissue plasminogen activator (tPA) use.||0.26|-0.09|
72498794|NCT01955707|144527866|SUPERIORITY_OR_OTHER||ratio of relative growth|1.09||||0.779|TWO_SIDED|90.0|0.91|1.3||one-sided p-value|repeated measures mixed effects model||Adjusted mean (log-scale) back-transformed to the original scale as the estimated ratio of natalizumab to placebo. 90% confidence interval (log-scale) back-transformed to the original scale and reflect the interval around the ratio.|||1.30|0.91|0.779
72498795|NCT01955707|144527867|SUPERIORITY_OR_OTHER||adjusted mean difference (log-scale)|0.09|||||TWO_SIDED|90.0|-0.09|0.27||||||Treatment contrasts derived from a repeated measures mixed effects model modeling log relative growth relative to baseline using an autoregressive variance-covariance matrix structure. The model adjusts for treatment, time, treatment by time, log baseline DWI volume, treatment time window, and tPA use.||0.27|-0.09|
72498796|NCT01955707|144527867|SUPERIORITY_OR_OTHER||ratio of relative growth|1.09||||0.797|TWO_SIDED|90.0|0.92|1.31||one-sided p-value|repeated measures mixed effects model||Adjusted mean (log-scale) back-transformed to the original scale as the estimated ratio of natalizumab to placebo. 90% confidence interval (log-scale) back-transformed to the original scale and reflect the interval around the ratio.|||1.31|0.92|0.797
72622404|NCT03131479|144774710|EQUIVALENCE|Change from baseline was analyzed using a repeated measures model which included diabetic status, renal function, day and renal function\*day and diabetic status\*day as fixed factors and age, baseline body weight and baseline fasting plasma glucose as covariates.|adjusted arithmetic mean difference|-21.5||||0.001|TWO_SIDED|90.0|-31.79|4.55|||Regression, Logistic|||||4.55|-31.79|0.001
72370208|NCT04380519|144250954|SUPERIORITY||Risk Ratio (RR)|1.125||||0.073|ONE_SIDED|97.5|0.989|||Hochberg adjustment was applied for p-values|Maximal Likelihood Estimator (MLE) model||||||0.989|0.073
72370209|NCT04380519|144250956|SUPERIORITY||Risk Ratio (RR)|1.019||||0.393|ONE_SIDED|97.5|0.892|||unadjusted|Maximal Likelihood Estimator (MLE) model||||||0.892|0.393
72619557|NCT03537729|144769954|SUPERIORITY|Sample size was determined by power analysis for the adjusted wayfinding speed.|Ratio of mean proportions of errors|1.26||||0.26|TWO_SIDED|95.0|0.84|1.88||P-value was not adjusted for multiple comparisons. A priori threshold for statistical significance was .05.|Generalized mixed model analysis|Covariates included baseline value of the outcome, age, sex, and cognition score at baseline, and use of wheelchair on the route.|Ratio of mean proportion of errors for cues divided by proportion of errors for control. Log of the mean was estimated from generalized linear mixed effects models for each arm. The difference between logs of means was exponentiated.|The null hypothesis was that means of two arms on the high complexity route are equal, the alternative was that means were not equal.||1.88|0.84|.26
72619558|NCT03537729|144769954|SUPERIORITY|Sample size was determined by power analysis for the adjusted wayfinding speed.|Ratio of mean proportions of errors|0.79||||0.25|TWO_SIDED|95.0|0.53|1.19||P-value was not adjusted for multiple comparisons. A priori threshold for statistical significance was .05.|Generalized mixed model analysis|Covariates included baseline value of the outcome, age, sex, and cognition score at baseline, and use of wheelchair on the route.|Ratio of mean proportion of errors for spaced retrieval divided by proportion of errors for control. Log of the mean was estimated from generalized linear mixed effects models for each arm. The difference between logs of means was exponentiated.|The null hypothesis was that means of two arms on the high complexity route are equal, the alternative was that means were not equal.||1.19|0.53|.25
72622405|NCT03131479|144774710|EQUIVALENCE|Change from baseline was analyzed using a repeated measures model which included diabetic status, renal function, day and renal function\*day and diabetic status\*day as fixed factors and age, baseline body weight and baseline fasting plasma glucose as covariates.|adjusted arithmetic mean difference|-35.6||||0|TWO_SIDED|90.0|-46.0|-25.11|||Regression, Logistic|||||-25.11|-46.00|0.000
72449372|NCT04800211|144416705|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is equal to zero on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is NOT equal to zero on Visit 5 (Week 6). (mITT Population)|Mean Difference (Net)|-35.556||||0.0031|TWO_SIDED|95.0|-59.038|-12.075|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is equal to zero on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is NOT equal to zero on Visit 5 (Week 6). (mITT Population)||-12.075|-59.038|0.0031
72449373|NCT04800211|144416705|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is NOT equal to zero on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|-31.35||||0.0371|TWO_SIDED|95.0|-60.818|-1.882|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is NOT equal to zero on Visit 7 (Week 12). (mITT Population)||-1.882|-60.818|0.0371
72449374|NCT04800211|144416705|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 2 is equal to zero on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 2 is NOT equal to zero on Visit 5 (Week 6). (mITT Population)|Mean Difference (Net)|-34.356||||0.0043|TWO_SIDED|95.0|-57.877|-10.834|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 2 is equal to zero on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 2 is NOT equal to zero on Visit 5 (Week 6). (mITT Population)||-10.834|-57.877|0.0043
72469542|NCT00781937|144462850|SUPERIORITY_OR_OTHER||Treatment Contrast|2.35||||0.3689||95.0|-2.79|7.49||Two sided, conducted at a 5% significance level|ANCOVA|The analysis included treatment, gender, country and stratification factor(s) as fixed effects and randomisation value of the endpoint as covariate.||||7.49|-2.79|0.3689
72469543|NCT00781937|144462851|SUPERIORITY_OR_OTHER||Treatment Contrast|-0.1||||0.0053||95.0|-0.16|-0.03||Two sided, conducted at a 5% significance level|ANCOVA|The analysis included treatment, gender, country and stratification factor(s) as fixed effects and randomisation value of the endpoint as covariate.||||-0.03|-0.16|0.0053
72469544|NCT00781937|144462852|SUPERIORITY_OR_OTHER||Treatment Contrast|-0.38|||<|0.0001||95.0|-0.5|-0.26||Two sided, conducted at a 5% significance level|ANCOVA|The analysis included treatment, gender, country and stratification factor(s) as fixed effects and randomisation value of the endpoint as covariate.||||-0.26|-0.50|<0.0001
72469545|NCT00781937|144462853|SUPERIORITY_OR_OTHER||Treatment Contrast|-1.85||||0.0147||95.0|-3.34|-0.37||Two sided, conducted at a 5% significance level|ANCOVA|The analysis included treatment, gender, country and stratification factor(s) as fixed effects and randomisation value of the endpoint as covariate.||||-0.37|-3.34|0.0147
72469546|NCT00781937|144462854|SUPERIORITY_OR_OTHER||Treatment Contrast|-0.27|||<|0.0001||95.0|-0.33|-0.21||Two sided, conducted at a 5% significance level|ANCOVA|The analysis included treatment, gender, country and stratification factor(s) as fixed effects and randomisation value of the endpoint as covariate.||||-0.21|-0.33|<0.0001
72370210|NCT04380519|144250956|SUPERIORITY||Risk Ratio (RR)|1.098||||0.061|ONE_SIDED|97.5|0.975|||unadjusted|Maximal Likelihood Estimator (MLE) model||||||0.975|0.061
72370211|NCT04380519|144250957|SUPERIORITY||Risk Ratio (RR)|0.67|||||TWO_SIDED|95.0|0.31|1.44||||||||1.44|0.31|
72370212|NCT04380519|144250957|SUPERIORITY||Risk Ratio (RR)|0.33|||||TWO_SIDED|95.0|0.12|0.89||||||||0.89|0.12|
72449375|NCT04800211|144416705|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 2 is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 2 is NOT equal to zero on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|-18.096||||0.2091|TWO_SIDED|95.0|-46.375|10.183|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 2 is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 2 is NOT equal to zero on Visit 7 (Week 12). (mITT Population)||10.183|-46.375|0.2091
72449376|NCT04800211|144416705|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 + Test 2 is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 + Test 2 is NOT equal to zero on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|-24.723||||0.0197|TWO_SIDED|95.0|-45.473|-3.973|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 + Test 2 is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 + Test 2 is NOT equal to zero on Visit 7 (Week 12). (mITT Population)||-3.973|-45.473|0.0197
72449377|NCT04800211|144416705|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Control is equal to zero on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Control is NOT equal to zero on Visit 5 (Week 6). (mITT Population)|Mean Difference (Net)|-13.595||||0.2353|TWO_SIDED|95.0|-36.08|8.891|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Control is equal to zero on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Control is NOT equal to zero on Visit 5 (Week 6). (mITT Population)||8.891|-36.080|0.2353
72469547|NCT00013611|144462857|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.91||||0.47|TWO_SIDED|95.0|0.7|1.18|||Regression, Cox|Stratification by CD4+ count stratum (50-199 or 200-299) and country of randomization.||Null hypothesis was that event rates in two groups are equal. Study was designed with 80%, two-sided alpha=.05, assuming a 28% reduction in the hazard of opportunistic disease or death.||1.18|0.70|0.47
72469548|NCT00013611|144462858|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.06||||0.73|TWO_SIDED|95.0|0.77|1.44|||Regression, Cox|Stratification by CD4+ stratum and country of randomization.||||1.44|0.77|0.73
72498797|NCT01955707|144527868|SUPERIORITY_OR_OTHER||Adjusted mean difference (log-scale)|0.05|||||TWO_SIDED|90.0|-0.13|0.24||||||Treatment contrasts derived from a repeated measures mixed effects model modeling log relative growth relative to baseline using an autoregressive variance-covariance matrix structure. The model adjusts for treatment, time, treatment by time, log baseline DWI volume, treatment time window, and tPA use.||0.24|-0.13|
72498798|NCT01955707|144527868|SUPERIORITY_OR_OTHER||ratio of relative growth|1.05||||0.684|TWO_SIDED|90.0|0.88|1.27||one-sided p-value|repeated measures mixed effects model||Adjusted mean (log-scale) back-transformed to the original scale as the estimated ratio of natalizumab to placebo. 90% confidence interval (log-scale) back-transformed to the original scale and reflect the interval around the ratio.|||1.27|0.88|0.684
72498799|NCT01955707|144527869|SUPERIORITY_OR_OTHER||Adjusted mean difference (log-scale)|0.0|||||TWO_SIDED|90.0|-0.12|0.11||||||Treatment contrasts derived from a repeated measures mixed effects model modeling log relative growth relative to 24 hours using an autoregressive variance-covariance matrix structure. The model adjusts for treatment, time, treatment by time, log baseline DWI volume, treatment time window, and tPA use.||0.11|-0.12|
72498800|NCT01955707|144527869|SUPERIORITY_OR_OTHER||ratio of relative growth|1.0||||0.487|TWO_SIDED|90.0|0.89|1.12||one-sided p-value|repeated measures mixed effects model||Adjusted mean (log-scale) back-transformed to the original scale as the estimated ratio of natalizumab to placebo. 90% confidence interval (log-scale) back-transformed to the original scale and reflect the interval around the ratio.|||1.12|0.89|0.487
72498801|NCT01955707|144527870|SUPERIORITY_OR_OTHER||Adjusted mean difference (log-scale)|-0.02|||||TWO_SIDED|90.0|-0.14|0.1||||||Treatment contrasts derived from a repeated measures mixed effects model modeling log relative growth relative to 24 hours using an autoregressive variance-covariance matrix structure. The model adjusts for treatment, time, treatment by time, log baseline DWI volume, treatment time window, and tPA use.||0.10|-0.14|
72498802|NCT01955707|144527870|SUPERIORITY_OR_OTHER||ratio of relative growth|0.98||||0.402|TWO_SIDED|90.0|0.87|1.11||one-sided p-value|repeated measures mixed effects model||Adjusted mean (log-scale) back-transformed to the original scale as the estimated ratio of natalizumab to placebo. 90% confidence interval (log-scale) back-transformed to the original scale and reflect the interval around the ratio.|||1.11|0.87|0.402
72498803|NCT01955707|144527871|SUPERIORITY_OR_OTHER||Adjusted mean difference (log-scale)|-0.02|||||TWO_SIDED|90.0|-0.18|0.13||||||Treatment contrasts derived from a repeated measures mixed effects model modeling log relative growth relative to Day 5 using an autoregressive variance-covariance matrix structure. The model adjusts for for treatment, log baseline DWI volume, treatment time window, and tPA use.||0.13|-0.18|
72561778|NCT01074008|144654158|SUPERIORITY_OR_OTHER|||||||0.111|TWO_SIDED|||||There was no adjustment for multiple comparisons and the pre-specified, two-sided significance level was ≤ 0.05.|Fisher Exact|||||||0.111
72561779|NCT01074008|144654159|SUPERIORITY_OR_OTHER|||||||0.013|TWO_SIDED|||||There was no adjustment for multiple comparisons and the pre-specified, two-sided significance level was ≤ 0.05.|Fisher Exact|||||||0.013
72561780|NCT01074008|144654159|SUPERIORITY_OR_OTHER|||||||0.059|TWO_SIDED|||||There was no adjustment for multiple comparisons and the pre-specified, two-sided significance level was ≤ 0.05.|Fisher Exact|||||||0.059
72449378|NCT04800211|144416705|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Control is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Control is NOT equal to zero on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|-4.759||||0.7329|TWO_SIDED|95.0|-32.159|22.641|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Control is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Control is NOT equal to zero on Visit 7 (Week 12). (mITT Population)||22.641|-32.159|0.7329
72449379|NCT04800211|144416705|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is equal to Control on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is NOT equal to Control on Visit 5 (Week 6). (mITT Population)|Mean Difference (Net)|-21.962||||0.542|TWO_SIDED|95.0|-62.989|19.065|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is equal to Control on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is NOT equal to Control on Visit 5 (Week 6). (mITT Population)||19.065|-62.989|0.5420
72449380|NCT04800211|144416705|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|-26.591||||0.5234|TWO_SIDED|95.0|-77.049|23.866|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)||23.866|-77.049|0.5234
72449381|NCT04800211|144416705|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 2 is equal to Control on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 2 is NOT equal to Control on Visit 5 (Week 6). (mITT Population)|Mean Difference (Net)|-20.761||||0.5975|TWO_SIDED|95.0|-61.867|20.344|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 2 is equal to Control on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 2 is NOT equal to Control on Visit 5 (Week 6). (mITT Population)||20.344|-61.867|0.5975
72449382|NCT04800211|144416705|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|-13.337||||0.9331|TWO_SIDED|95.0|-62.853|36.179|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)||36.179|-62.853|0.9331
72469549|NCT00013611|144462859|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.73||||0.1|TWO_SIDED|95.0|0.51|1.06|||Regression, Cox|Stratification by CD4+ stratum and country of randomization.||||1.06|0.51|0.10
72469550|NCT00013611|144462860|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.1||||0.35|TWO_SIDED|95.0|0.9|1.34|||Regression, Cox|||||1.34|0.90|0.35
72469551|NCT00013611|144462861|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|53.0|STANDARD_ERROR_OF_MEAN|6.5|<|0.001|TWO_SIDED|95.0|40.3|65.7|||Mixed Models Analysis|||||65.7|40.3|< 0.001
72469552|NCT01013961|144462867|SUPERIORITY_OR_OTHER_LEGACY|||||||0.722|TWO_SIDED||||||Fisher Exact|||||||0.722
72469553|NCT01013961|144462868|SUPERIORITY_OR_OTHER_LEGACY|||||||1|TWO_SIDED||||||Fisher Exact|||||||1.0
72469554|NCT00420784|144462918|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|8.23|||<|0.001|TWO_SIDED|95.0|4.14|16.36|||Regression, Logistic|||||16.36|4.14|<0.001
72469555|NCT00420784|144462918|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|9.52|||<|0.001|TWO_SIDED|95.0|4.72|19.2|||Regression, Logistic|||||19.20|4.72|<0.001
72469556|NCT00420784|144462918|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.31||||0.024|TWO_SIDED|95.0|1.12|4.75|||Regression, Logistic|||||4.75|1.12|0.024
72469557|NCT00420784|144462920|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.64|||<|0.001|TWO_SIDED|95.0|3.41|12.96|||Regression, Logistic|||||12.96|3.41|<0.001
72469558|NCT00420784|144462920|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.72|||<|0.001|TWO_SIDED|95.0|2.91|11.27|||Regression, Logistic|||||11.27|2.91|<0.001
72469559|NCT00420784|144462920|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.95||||0.067|TWO_SIDED|95.0|0.95|4.0|||Regression, Logistic|||||4.00|0.95|0.067
72469560|NCT03603639|144462941|SUPERIORITY||LS Mean difference|1.38|||||TWO_SIDED|90.0|-0.72|3.48||||||The mixed effects model for the crossover part of the study will include treatment, period, and sequence as fixed effects, baseline (Predose) measurement as a covariate, and subject nested within sequence as a random effect.||3.48|-0.72|
72449383|NCT04800211|144416705|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 + Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 + Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|-19.964||||0.2444|TWO_SIDED|95.0|-53.637|13.709|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 + Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 + Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)||13.709|-53.637|0.2444
72449384|NCT04800211|144416705|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is equal to Test 2 on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is NOT equal to Test 2 on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|-13.254||||0.5169|TWO_SIDED|95.0|-53.427|26.919|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is equal to Test 2 on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is NOT equal to Test 2 on Visit 7 (Week 12). (mITT Population)||26.919|-53.427|0.5169
72449385|NCT04800211|144416706|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-40.174||||0.1359|TWO_SIDED|95.0|-93.12|12.772|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||12.772|-93.120|0.1359
72449386|NCT04800211|144416706|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-71.725||||0.0129|TWO_SIDED|95.0|-127.961|-15.49|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||-15.490|-127.961|0.0129
72469561|NCT03603639|144462941|SUPERIORITY||LS Mean difference|1.07|||||TWO_SIDED|90.0|-0.49|2.63||||||The mixed effects model for the crossover part of the study will include treatment, period, and sequence as fixed effects, baseline (Predose) measurement as a covariate, and subject nested within sequence as a random effect.||2.63|-0.49|
72469562|NCT03603639|144462942|SUPERIORITY||LS Mean Difference|0.39|||||TWO_SIDED|90.0|-0.75|1.54||||||In eye closure condition. The mixed effects model for the crossover part of the study will include treatment, period, and sequence as fixed effects, baseline (Predose) measurement as a covariate, and subject nested within sequence as a random effect.||1.54|-0.75|
72469931|NCT03728985|144463715|NON_INFERIORITY|Performance Goal 68%|Percentage with Success|70.6||||0.7017|TWO_SIDED|90.0|61.4|78.7|||Fisher Exact|||||78.7|61.4|0.7017
72370213|NCT04380519|144250957|SUPERIORITY||Odds Ratio (OR)|0.64|||||TWO_SIDED|95.0|0.28|1.49||||||||1.49|0.28|
72469932|NCT05146206|144463835|OTHER||||||<|0.001|||||||ANOVA|||||||<.001
72469933|NCT05146206|144463836|OTHER||||||<|0.001|||||||MANOVA|||||||<0.001
72469934|NCT02577003|144463837|SUPERIORITY||Difference in least squares means|-0.77|||<|0.001|TWO_SIDED|95.0|-0.98|-0.57|||Constrained longitudinal data analysis|Based on a cLDA model with the terms listed above.||||-0.57|-0.98|<0.001
72469935|NCT02577003|144463840|SUPERIORITY||Difference in least squares means|-28.1|||<|0.001|TWO_SIDED|95.0|-34.8|-21.5|||Constrained longitudinal data analysis|Based on a cLDA model with the terms listed above.||||-21.5|-34.8|<0.001
72469936|NCT02577003|144463841|SUPERIORITY||Difference in least squares means|-48.5|||<|0.001|TWO_SIDED|95.0|-59.6|-37.5|||Constrained longitudinal data analysis|Based on a cLDA model with the terms listed above.||||-37.5|-59.6|<0.001
72469937|NCT02577003|144463842|SUPERIORITY||Difference in least squares means|-84.6|||<|0.001|TWO_SIDED|95.0|-102.6|-66.6|||Constrained longitudinal data analysis|Based on a cLDA model with the terms listed above.||||-66.6|-102.6|<0.001
72370214|NCT04380519|144250957|SUPERIORITY||Odds Ratio (OR)|0.31|||||TWO_SIDED|95.0|0.11|0.87||||||||0.87|0.11|
72370215|NCT04380519|144250958|SUPERIORITY||Risk Ratio (RR)|2.35|||||TWO_SIDED|95.0|0.93|5.92||||||||5.92|0.93|
72370216|NCT04380519|144250958|SUPERIORITY||Risk Ratio (RR)|1.5|||||TWO_SIDED|95.0|0.55|4.09||||||||4.09|0.55|
72370217|NCT04380519|144250958|SUPERIORITY||Odds Ratio (OR)|2.53|||||TWO_SIDED|95.0|0.94|6.81||||||||6.81|0.94|
72370218|NCT04380519|144250958|SUPERIORITY||Odds Ratio (OR)|1.54|||||TWO_SIDED|95.0|0.53|4.46||||||||4.46|0.53|
72449387|NCT04800211|144416706|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-37.308||||0.3262|TWO_SIDED|95.0|-112.293|37.678|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||37.678|-112.293|0.3262
72469563|NCT03603639|144462942|SUPERIORITY||LS Mean Difference|0.3|||||TWO_SIDED|90.0|-0.6|1.21||||||In eye closure condition. The mixed effects model for the crossover part of the study will include treatment, period, and sequence as fixed effects, baseline (Predose) measurement as a covariate, and subject nested within sequence as a random effect.||1.21|-0.60|
72498804|NCT01955707|144527871|SUPERIORITY_OR_OTHER||ratio of relative growth|0.98||||0.394|TWO_SIDED|90.0|0.84|1.14||one-sided p-value|repeated measures mixed effects model||Adjusted mean (log-scale) back-transformed to the original scale as the estimated ratio of natalizumab to placebo. 90% confidence interval (log-scale) back-transformed to the original scale and reflect the interval around the ratio.|||1.14|0.84|0.394
72622406|NCT04439903|144774780|OTHER||Intercept|1.9726|STANDARD_ERROR_OF_MEAN|3.8238||0.61532|TWO_SIDED||||||Regression, Linear|||||||0.61532
72469564|NCT03603639|144462942|SUPERIORITY||LS Mean Difference|1.62|||||TWO_SIDED|90.0|-1.16|4.39||||||In eyes closed condition. The mixed effects model for the crossover part of the study will include treatment, period, and sequence as fixed effects, baseline (Predose) measurement as a covariate, and subject nested within sequence as a random effect.||4.39|-1.16|
72498805|NCT01955707|144527872|SUPERIORITY_OR_OTHER||adjusted mean change from baseline|-0.25||||0.427|TWO_SIDED|90.0|-2.48|1.98||one-sided p-value|repeated measures mixed effects model|||Analysis of NIHSS score and change from Baseline at 24 hours. The repeated measures mixed effects model is modeling absolute change in NIHSS score relative to baseline and using an autoregressive variance-covariance matrix. The model adjusts for treatment, time, treatment by time, log baseline DWI volume, treatment time window, tPA use, baseline NIHSS score and location of stroke.||1.98|-2.48|0.427
72498806|NCT01955707|144527872|SUPERIORITY_OR_OTHER||adjusted mean change from baseline|1.71||||0.896|TWO_SIDED|90.0|-0.52|3.94||one-sided p-value|repeated measures mixed effects model|||Analysis of NIHSS score and change from Baseline at Day 5. The repeated measures mixed effects model is modeling absolute change in NIHSS score relative to baseline and using an autoregressive variance-covariance matrix. The model adjusts for treatment, time, treatment by time, log baseline DWI volume, treatment time window, tPA use, baseline NIHSS score and location of stroke.||3.94|-0.52|0.896
72498807|NCT01955707|144527872|SUPERIORITY_OR_OTHER||adjusted mean change from baseline|3.15||||0.989|TWO_SIDED|90.0|0.89|5.4||one-sided p-value|repeated measures mixed effects model|||Analysis of NIHSS score and change from Baseline at Day 30. The repeated measures mixed effects model is modeling absolute change in NIHSS score relative to baseline and using an autoregressive variance-covariance matrix. The model adjusts for treatment, time, treatment by time, log baseline DWI volume, treatment time window, tPA use, baseline NIHSS score and location of stroke.||5.40|0.89|0.989
72498808|NCT01955707|144527872|SUPERIORITY_OR_OTHER||adjusted mean change from baseline|1.93||||0.915|TWO_SIDED|90.0|-0.38|4.25||one-sided p-value|repeated measures mixed effects model|||Analysis of NIHSS score and change from Baseline at Day 90. The repeated measures mixed effects model is modeling absolute change in NIHSS score relative to baseline and using an autoregressive variance-covariance matrix. The model adjusts for treatment, time, treatment by time, log baseline DWI volume, treatment time window, tPA use, baseline NIHSS score and location of stroke.||4.25|-0.38|0.915
72498809|NCT01955707|144527873|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.89||||0.564|TWO_SIDED|90.0|0.55|1.45||One sided p-value based on Van Elteren's test, adjusting for baseline DWI volume (\< median vs \>= median), treatment time window, location of stroke abnormality (cortical/subcortical), and tPA use (yes/no).|Van Elteren's test|||Analysis of distribution of mRS scores at Day 5. Odds ratio from a proportional-odds logistic regression model assuming a common odds ratio across all cut points of the mRS score. Covariates include baseline DWI volume (\< median vs \>= median), treatment time window, location of stroke abnormality (cortical/subcortical), and tPA use (yes/no).||1.45|0.55|0.564
72498810|NCT01955707|144527873|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.3||||0.077|TWO_SIDED|90.0|0.8|2.1||One-sided p-value based on Van Elteren's test, adjusting for baseline DWI volume (\< median vs \>= median), treatment time window, location of stroke abnormality (cortical/subcortical), and tPA use (yes/no).|Van Elteren's test|||Analysis of distribution of mRS scores at Day 30. Odds ratio from a proportional-odds logistic regression model assuming a common odds ratio across all cut points of the mRS score. Covariates include baseline DWI volume (\< median vs \>= median), treatment time window, location of stroke abnormality (cortical/subcortical), and tPA use (yes/no).||2.10|0.80|0.077
72561781|NCT01074008|144654159|SUPERIORITY_OR_OTHER|||||||0.013|TWO_SIDED|||||There was no adjustment for multiple comparisons and the pre-specified, two-sided significance level was ≤ 0.05.|Fisher Exact|||||||0.013
72561782|NCT01074008|144654159|SUPERIORITY_OR_OTHER|||||||0.013|TWO_SIDED|||||There was no adjustment for multiple comparisons and the pre-specified, two-sided significance level was ≤ 0.05.|Fisher Exact|||||||0.013
72561783|NCT01074008|144654159|SUPERIORITY_OR_OTHER|||||||0.37|TWO_SIDED|||||There was no adjustment for multiple comparisons and the pre-specified, two-sided significance level was ≤ 0.05.|Fisher Exact|||||||0.370
72561784|NCT01074008|144654159|SUPERIORITY_OR_OTHER|||||||0.013|TWO_SIDED|||||There was no adjustment for multiple comparisons and the pre-specified, two-sided significance level was ≤ 0.05.|Fisher Exact|||||||0.013
72561785|NCT01074008|144654159|SUPERIORITY_OR_OTHER|||||||0.013|TWO_SIDED|||||There was no adjustment for multiple comparisons and the pre-specified, two-sided significance level was ≤ 0.05.|Fisher Exact|||||||0.013
72561786|NCT01074008|144654159|SUPERIORITY_OR_OTHER|||||||0.013|TWO_SIDED|||||There was no adjustment for multiple comparisons and the pre-specified, two-sided significance level was ≤ 0.05.|Fisher Exact|||||||0.013
72449388|NCT04800211|144416706|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 2 is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 2 is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-20.012||||0.4343|TWO_SIDED|95.0|-70.468|30.444|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 2 is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 2 is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||30.444|-70.468|0.4343
72449389|NCT04800211|144416706|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 2 is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 2 is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-44.657||||0.0967|TWO_SIDED|95.0|-97.481|8.167|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 2 is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 2 is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||8.167|-97.481|0.0967
72498811|NCT01955707|144527873|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.15||||0.243|TWO_SIDED|90.0|0.71|1.86||One -sided p-value based on Van Elteren's test, adjusting for baseline DWI volume (\< median vs \>= median), treatment time window, location of stroke abnormality (cortical/subcortical), and tPA use (yes/no).|Van Elteren's test|||Analysis of the distribution of mRS scores at Day 90. Odds ratio from a proportional-odds logistic regression model assuming a common odds ratio across all cut points of the mRS score. Covariates include baseline DWI volume (\< median vs \>= median), treatment time window, location of stroke abnormality (cortical/subcortical), and tPA use (yes/no).||1.86|0.71|0.243
72498812|NCT01955707|144527874|SUPERIORITY_OR_OTHER||Adjusted mean|0.68||||0.455|TWO_SIDED|90.0|-9.19|10.56||one-sided p-value|repeated measures mixed effects model|||Analysis of Barthel Index at Day 5. The repeated measures mixed effects model is modeling Barthel Index using an autoregressive variance-covariance matrix. The model adjusts for treatment, time, treatment by time, log baseline DWI volume, treatment time window, tPA use, and location of stroke.||10.56|-9.19|0.455
72498813|NCT01955707|144527874|SUPERIORITY_OR_OTHER||Adjusted mean|1.21||||0.42|TWO_SIDED|90.0|-8.76|11.19||one-sided p-value|repeated measures mixed effects model|||Analysis of Barthel Index at Day 30. The repeated measures mixed effects model is modeling Barthel Index using an autoregressive variance-covariance matrix. The model adjusts for treatment, time, treatment by time, log baseline DWI volume, treatment time window, tPA use, and location of stroke.||11.19|-8.76|0.420
72498814|NCT01955707|144527874|SUPERIORITY_OR_OTHER||Adjusted mean|3.56||||0.283|TWO_SIDED|90.0|-6.64|13.75|||repeated measures mixed effects model|||Analysis of Barthel Index at Day 90/Final Visit. The repeated measures mixed effects model is modeling Barthel Index using an autoregressive variance-covariance matrix. The model adjusts for treatment, time, treatment by time, log baseline DWI volume, treatment time window, tPA use, and location of stroke.||13.75|-6.64|0.283
72498815|NCT01817790|144527876|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-0.36||||0.0024|TWO_SIDED|95.0|-0.59|-0.13||p-value was not adjusted for multiple comparisons.|ANCOVA|Linear Fixed-effect Model; Treatment and site as fixed factors and baseline score as covariate.||Null hypothesis was that no difference exists in the mean change from baseline in Daily rTOSS between the Fluticasone nasal spray and the placebo nasal spray.||-0.13|-0.59|0.0024
72498816|NCT01817790|144527877|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-0.33||||0.0057|TWO_SIDED|95.0|-0.56|-0.1||p-value was not adjusted for multiple comparisons.|ANCOVA|Linear Fixed-effect Model; Treatment and site as fixed factors and baseline score as covariate.||Null hypothesis was that no difference exists in the mean change from baseline in AM rTOSS between the Fluticasone nasal spray and the placebo nasal spray.||-0.10|-0.56|0.0057
72370219|NCT01727024|144250959|SUPERIORITY_OR_OTHER|||||||0.451|||||||Generalized Estimating Equation (GEE)|||||||0.451
72498817|NCT01817790|144527878|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-0.41||||0.0009||95.0|-0.65|-0.17||p-value was not adjusted for multiple comparisons.|ANCOVA|Linear Fixed-effect Model; Treatment and site as fixed factors and baseline score as covariate.||Null hypothesis was that no difference exists in the mean change from baseline in PM rTOSS between the Fluticasone nasal spray and the placebo nasal spray.||-0.17|-0.65|0.0009
72498818|NCT01817790|144527879|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-0.1||||0.0117|TWO_SIDED|95.0|-0.19|-0.02||p-value was not adjusted for multiple comparisons.|ANCOVA|Linear Fixed-effect Model; Treatment and site as fixed factors and baseline score as covariate.||Null hypothesis was that no difference exists in the mean change from baseline in AM reflective symptom scores for Eye itching/burning between the Fluticasone nasal spray and the placebo nasal spray.||-0.02|-0.19|0.0117
72561787|NCT01074008|144654172|SUPERIORITY_OR_OTHER|||||||0.005|TWO_SIDED|||||There was no adjustment for multiple comparisons and the pre-specified, two-sided significance level was ≤ 0.05.|Fisher Exact|||||||0.005
72561788|NCT01074008|144654172|SUPERIORITY_OR_OTHER|||||||0.005|TWO_SIDED|||||There was no adjustment for multiple comparisons and the pre-specified, two-sided significance level was ≤ 0.05.|Fisher Exact|||||||0.005
72561789|NCT01074008|144654172|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||There was no adjustment for multiple comparisons and the pre-specified, two-sided significance level was ≤ 0.05.|Fisher Exact|||||||<0.001
72561790|NCT01074008|144654172|SUPERIORITY_OR_OTHER|||||||0.024|TWO_SIDED|||||There was no adjustment for multiple comparisons and the pre-specified, two-sided significance level was ≤ 0.05.|Fisher Exact|||||||0.024
72449390|NCT04800211|144416706|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test2 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test2 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-28.974||||0.4198|TWO_SIDED|95.0|-99.915|41.966|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test2 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test2 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||41.966|-99.915|0.4198
72449391|NCT04800211|144416706|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 + Test 2 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 + Test 2 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-33.141||||0.2121|TWO_SIDED|95.0|-85.475|19.193|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 + Test 2 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 + Test 2 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||19.193|-85.475|0.2121
72469565|NCT03603639|144462942|SUPERIORITY||LS Mean Difference|1.05|||||TWO_SIDED|90.0|-0.89|2.98||||||In eyes closed condition. The mixed effects model for the crossover part of the study will include treatment, period, and sequence as fixed effects, baseline (Predose) measurement as a covariate, and subject nested within sequence as a random effect.||2.98|-0.89|
72561791|NCT01074008|144654172|SUPERIORITY_OR_OTHER|||||||0.319|TWO_SIDED|||||There was no adjustment for multiple comparisons and the pre-specified, two-sided significance level was ≤ 0.05.|Fisher Exact|||||||0.319
72561792|NCT01074008|144654172|SUPERIORITY_OR_OTHER|||||||0.013|TWO_SIDED|||||There was no adjustment for multiple comparisons and the pre-specified, two-sided significance level was ≤ 0.05.|Fisher Exact|||||||0.013
72561793|NCT01074008|144654172|SUPERIORITY_OR_OTHER|||||||0.005|TWO_SIDED|||||There was no adjustment for multiple comparisons and the pre-specified, two-sided significance level was ≤ 0.05.|Fisher Exact|||||||0.005
72561794|NCT01074008|144654172|SUPERIORITY_OR_OTHER|||||||0.074|TWO_SIDED|||||There was no adjustment for multiple comparisons and the pre-specified, two-sided significance level was ≤ 0.05.|Fisher Exact|||||||0.074
72561795|NCT00578968|144654211|SUPERIORITY_OR_OTHER|||||||0.01||95.0|||||ANOVA|||||||0.01
72561796|NCT00578968|144654212|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA|||||||<0.001
72469566|NCT03603639|144462942|SUPERIORITY||LS Mean Difference|0.21|||||TWO_SIDED|90.0|-1.87|2.28||||||In eyes open condition. The mixed effects model for the crossover part of the study will include treatment, period, and sequence as fixed effects, baseline (Predose) measurement as a covariate, and subject nested within sequence as a random effect.||2.28|-1.87|
72469567|NCT03603639|144462942|SUPERIORITY||LS Mean Difference|1.27|||||TWO_SIDED|90.0|-0.57|3.11||||||In eyes open condition. The mixed effects model for the crossover part of the study will include treatment, period, and sequence as fixed effects, baseline (Predose) measurement as a covariate, and subject nested within sequence as a random effect.||3.11|-0.57|
72469568|NCT00607672|144462954|SUPERIORITY_OR_OTHER|||||||0.28||95.0|||||Mixed Models Analysis|||||||0.28
72469569|NCT00607672|144462955|SUPERIORITY_OR_OTHER|||||||0.84||95.0|||||Mixed Models Analysis|||||||0.84
72469570|NCT00607672|144462956|SUPERIORITY_OR_OTHER|||||||0.67||95.0|||||Kruskal-Wallis|||||||0.67
72469571|NCT00607672|144462957|SUPERIORITY_OR_OTHER|||||||0.73||95.0|||||Chi-squared|||||||0.73
72469572|NCT00607672|144462958|SUPERIORITY_OR_OTHER|||||||0.04||95.0||||For plasma transfusion comparison. Ramipril and Candesartan versus placebo|Chi-squared|||||||0.04
72469573|NCT00607672|144462959|SUPERIORITY_OR_OTHER|||||||0.27||95.0||||Comparison for norepinephrine use|Chi-squared|||||||0.27
72469574|NCT00607672|144462960|SUPERIORITY_OR_OTHER|||||||0.62||95.0|||||Chi-squared|||||||0.62
72469575|NCT00607672|144462961|SUPERIORITY_OR_OTHER|||||||0.51||95.0|||||Chi-squared|||||||0.51
72469576|NCT00607672|144462962|SUPERIORITY_OR_OTHER|||||||0.87||95.0|||||Chi-squared|||||||0.87
72469577|NCT00607672|144462963|SUPERIORITY_OR_OTHER|||||||0.04||95.0|||||Kruskal-Wallis|||||||0.04
72469578|NCT00607672|144462964|SUPERIORITY_OR_OTHER|||||||0.69||95.0|||||Mixed Models Analysis|||||||0.69
72469579|NCT00607672|144462965|SUPERIORITY_OR_OTHER|||||||0.97||95.0|||||Mixed Models Analysis|||||||0.97
72469580|NCT00607672|144462966|SUPERIORITY_OR_OTHER|||||||0.46||95.0|||||Mixed Models Analysis|||||||0.46
72469581|NCT00443209|144463025|SUPERIORITY_OR_OTHER||Treatment Difference|-6.2|||<|0.001|TWO_SIDED|95.0|-10.4|-2.6|||Miettenen and Nurminen method||Treatment Difference was compared using the Miettinen and Nurminen (MN) method.|||-2.6|-10.4|<0.001
72469582|NCT00443209|144463026|SUPERIORITY_OR_OTHER||Treatment Difference|-5.2|||||TWO_SIDED|95.0|-11.7|1.4|||||Treatment Difference was compared using the MN method.|||1.4|-11.7|
72469583|NCT00443209|144463027|SUPERIORITY_OR_OTHER||Treatment Difference|0.3|||||TWO_SIDED|95.0|-2.0|2.0|||||Treatment Difference was compared using the MN method.|||2.0|-2.0|
72469584|NCT00443209|144463029|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.58|||||TWO_SIDED|95.0|0.45|0.75|||||Based on mixed logistic regression model with a fixed effect term for treatment, baseline pain severity and a random effect term for participant, with the random effect following a normal distribution. An odds ratio \>1 is in favor of telcagepant.|||0.75|0.45|
72561797|NCT00578968|144654213|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA|||||||<0.001
72561798|NCT00578968|144654214|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA|||||||<0.001
72449392|NCT04800211|144416706|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Control is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Control is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|15.799||||0.5445|TWO_SIDED|95.0|-35.614|67.212|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Control is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Control is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||67.212|-35.614|0.5445
72449393|NCT04800211|144416706|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Control is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Control is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|1.583||||0.9534|TWO_SIDED|95.0|-51.951|55.116|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Control is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Control is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||55.116|-51.951|0.9534
72561799|NCT00578968|144654215|SUPERIORITY_OR_OTHER|||||||0.13||95.0|||||ANOVA|||Comparison between the two groups at baseline resting.||||0.13
72561800|NCT00578968|144654215|SUPERIORITY_OR_OTHER||||||<|0.01||95.0|||||ANOVA|||Comparison was made between the two groups at baseline peak exercise||||<0.01
72561801|NCT00578968|144654216|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA|||||||<0.001
72561802|NCT00578968|144654217|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||ANOVA|||||||<0.05
72561803|NCT00578968|144654218|SUPERIORITY_OR_OTHER|||||||0.15||95.0|||||ANOVA|||||||0.15
72561804|NCT00578968|144654219|SUPERIORITY_OR_OTHER|||||||0.01||95.0|||||ANOVA|||||||0.01
72561805|NCT00578968|144654220|SUPERIORITY_OR_OTHER|||||||0.85||95.0|||||ANOVA|||||||0.85
72469585|NCT00409409|144463037|SUPERIORITY_OR_OTHER|||||||0.001|||||||ANCOVA|||||||0.0010
72469586|NCT01653210|144463038|SUPERIORITY_OR_OTHER_LEGACY|||||||0.023|||||||ANOVA|||||||0.023
72469587|NCT00820664|144463040|SUPERIORITY_OR_OTHER||Least Squares Mean|0.49|||<|0.001||95.0|0.31|1.0||1-sided, alpha=0.05|ANOVA|A one-way ANOVA model with term treatment was fit to the square root transformed response.||||1.00|0.31|<0.001
72469588|NCT00820664|144463040|SUPERIORITY_OR_OTHER||Least Squares Mean|0.19||||0.032||95.0|0.02|1.0||1-sided, alpha=0.05|ANOVA|A one-way ANOVA model with term treatment was fit to the square root transformed response.||||1.00|0.02|0.032
72469589|NCT03635086|144463042|OTHER||Geometric Mean Ratio Estimate|1.1||||0.9998|TWO_SIDED|95.0|0.2|4.9|||Tukey-Kramer|||GMT ratios were estimated by applying an analysis of variance (ANOVA) including the factor treatment group. This was done using log10 transformed data and taking the anti-log of the resulting point estimates for the least squares means, least squares means differences and the corresponding 2-sided 95% confidence intervals (CI). P-values were also provided to compare GMTs between treatment groups adjusted for multiple comparisons according to Tukey-Kramer.||4.9|0.2|0.9998
72469590|NCT03635086|144463042|OTHER||Geometric Mean Ratio Estimate|1.5||||0.9345|TWO_SIDED|95.0|0.3|7.5|||Tukey-Kramer|||GMT ratios were estimated by applying an analysis of variance (ANOVA) including the factor treatment group. This was done using log10 transformed data and taking the anti-log of the resulting point estimates for the least squares means, least squares means differences and the corresponding 2-sided 95% confidence intervals (CI). P values were also provided to compare GMTs between treatment groups adjusted for multiple comparisons according to Tukey-Kramer.||7.5|0.3|0.9345
72469591|NCT03635086|144463042|OTHER||Geometric Mean Ratio Estimate|0.5||||0.5836|TWO_SIDED|95.0|0.1|2.1|||Tukey-Kramer|||GMT ratios were estimated by applying an analysis of variance (ANOVA) including the factor treatment group. This was done using log10 transformed data and taking the anti-log of the resulting point estimates for the least squares means, least squares means differences and the corresponding 2-sided 95% confidence intervals (CI). P-values were also provided to compare GMTs between treatment groups adjusted for multiple comparisons according to Tukey-Kramer.||2.1|0.1|0.5836
72469592|NCT03635086|144463042|OTHER||Geometric Mean Ratio Estimate|2.4||||0.4844|TWO_SIDED|95.0|0.5|10.6|||Tukey-Kramer|||GMT ratios were estimated by applying an analysis of variance (ANOVA) including the factor treatment group. This was done using log10 transformed data and taking the anti-log of the resulting point estimates for the least squares means, least squares means differences and the corresponding 2-sided 95% confidence intervals (CI). P-values were also provided to compare GMTs between treatment groups adjusted for multiple comparisons according to Tukey-Kramer.||10.6|0.5|0.4844
72469593|NCT03635086|144463042|OTHER||Geometric Mean Ratio Estimate|1.4||||0.9725|TWO_SIDED|95.0|0.3|6.8|||Tukey-Kramer|||GMT ratios were estimated by applying an analysis of variance (ANOVA) including the factor treatment group. This was done using log10 transformed data and taking the anti-log of the resulting point estimates for the least squares means, least squares means differences and the corresponding 2-sided 95% confidence intervals (CI). P-values were also provided to compare GMTs between treatment groups adjusted for multiple comparisons according to Tukey-Kramer.||6.8|0.3|0.9725
72469938|NCT02577003|144463843|SUPERIORITY||Difference in least squares means|-1.8|||<|0.001|TWO_SIDED|95.0|-2.5|-1.1|||Constrained longitudinal data analysis|Based on a cLDA model with the terms listed above.||||-1.1|-2.5|<0.001
72469939|NCT01677299|144463847|SUPERIORITY_OR_OTHER||LS mean diff (Day 5 - Baseline)|-22.5|||<|0.05|TWO_SIDED|95.0|-37.0|-8.0|||Mixed Models Analysis|Change in fasting plasma glucose from Baseline to Day 5 (end of treatment) for treatment A.||||-8|-37|<0.05
72449394|NCT04800211|144416706|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Control is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Control is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|7.584||||0.8366|TWO_SIDED|95.0|-65.126|80.295|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Control is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Control is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||80.295|-65.126|0.8366
72449395|NCT04800211|144416706|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is NOT equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-55.973||||0.5437|TWO_SIDED|95.0|-154.862|42.916|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is NOT equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||42.916|-154.862|0.5437
72449396|NCT04800211|144416706|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is NOT equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-73.308||||0.2974|TWO_SIDED|95.0|-177.224|30.608|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is NOT equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||30.608|-177.224|0.2974
72449397|NCT04800211|144416706|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-44.892||||0.9026|TWO_SIDED|95.0|-181.909|92.126|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||92.126|-181.909|0.9026
72469594|NCT03635086|144463042|OTHER||Geometric Mean Ratio Estimate|0.4||||0.4715|TWO_SIDED|95.0|0.1|1.9|||Tukey-Kramer|||GMT ratios were estimated by applying an analysis of variance (ANOVA) including the factor treatment group. This was done using log10 transformed data and taking the anti-log of the resulting point estimates for the least squares means, least squares means differences and the corresponding 2-sided 95% confidence intervals (CI). P values were also provided to compare GMTs between treatment groups adjusted for multiple comparisons according to Tukey-Kramer.||1.9|0.1|0.4715
72469940|NCT01677299|144463847|SUPERIORITY_OR_OTHER||LS mean diff (Day 5 - Baseline)|-20.0|||<|0.05|TWO_SIDED|95.0|-30.0|-9.0|||Mixed Models Analysis|Change in fasting plasma glucose from Baseline to Day 5 (end of treatment) for treatment B.||||-9|-30|<0.05
72469941|NCT01677299|144463847|SUPERIORITY_OR_OTHER||LS mean diff (Day 5 - Baseline)|-16.0|||<|0.05|TWO_SIDED|95.0|-24.0|-8.0|||Mixed Models Analysis|Change in fasting plasma glucose from Baseline to Day 5 (end of treatment) for treatment C.||||-8|-24|<0.05
72469942|NCT01677299|144463847|SUPERIORITY_OR_OTHER||LS mean diff (Day 5 - Baseline)|-21.0|||<|0.05|TWO_SIDED|95.0|-31.0|-11.0|||Mixed Models Analysis|Change in fasting plasma glucose from Baseline to Day 5 (end of treatment) for treatment D.||||-11|-31|<0.05
72469943|NCT01677299|144463848|SUPERIORITY_OR_OTHER||Geometric LS mean ration|1.6|||<|0.05|TWO_SIDED|95.0|1.4|1.9|||Mixed Models Analysis|||||1.9|1.4|<0.05
72469944|NCT01677299|144463848|SUPERIORITY_OR_OTHER||Geo LSmean ratio of (Day 5/Baseline)|1.9|||<|0.05|TWO_SIDED|95.0|1.5|2.3|||Mixed Models Analysis|||||2.3|1.5|<0.05
72469945|NCT01677299|144463848|SUPERIORITY_OR_OTHER||Geo LSmean ratio (Day 5/Baseline)|1.7|||<|0.05|TWO_SIDED|95.0|1.4|2.0|||Mixed Models Analysis|||||2.0|1.4|<0.05
72469946|NCT01677299|144463848|SUPERIORITY_OR_OTHER||Geo LSmean ratio (Day 5/Baseline)|1.9|||<|0.05|TWO_SIDED|95.0|1.5|2.3|||Mixed Models Analysis|||||2.3|1.5|<0.05
72469947|NCT01677299|144463849|SUPERIORITY_OR_OTHER||Geo LSmean ratio (Day 5/Baseline)|1.5|||<|0.05|TWO_SIDED|95.0|1.4|1.8|||Mixed Models Analysis|||||1.8|1.4|<0.05
72561806|NCT00578968|144654221|SUPERIORITY_OR_OTHER|||||||0.03||95.0|||||ANOVA|||||||0.03
72449398|NCT04800211|144416706|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 2 is equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 2 is NOT equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-35.811||||0.8954|TWO_SIDED|95.0|-132.513|60.891|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 2 is equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 2 is NOT equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||60.891|-132.513|0.8954
72449399|NCT04800211|144416706|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 2 is equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 2 is NOT equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-46.239||||0.7485|TWO_SIDED|95.0|-146.766|54.288|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 2 is equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 2 is NOT equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||54.288|-146.766|0.7485
72449400|NCT04800211|144416706|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 2 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 2 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-36.559||||0.9578|TWO_SIDED|95.0|-169.77|96.653|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 2 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 2 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||96.653|-169.770|0.9578
72449401|NCT04800211|144416706|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 + Test 2 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 + Test 2 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-40.725||||0.3635|TWO_SIDED|95.0|-129.208|47.757|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 + Test 2 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 + Test 2 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||47.757|-129.208|0.3635
72449402|NCT04800211|144416706|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 2 is equal to Test 1 on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 2 is NOT equal to Test 1 on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-8.333||||0.8713|TWO_SIDED|95.0|-110.097|93.431|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 2 is equal to Test 1 on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 2 is NOT equal to Test 1 on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||93.431|-110.097|0.8713
72469595|NCT03635086|144463042|OTHER||Geometric Mean Ratio Estimate|2.2||||0.5969|TWO_SIDED|95.0|0.5|9.6|||Tukey-Kramer|||GMT ratios were estimated by applying an analysis of variance (ANOVA) including the factor treatment group. This was done using log10 transformed data and taking the anti-log of the resulting point estimates for the least squares means, least squares means differences and the corresponding 2-sided 95% confidence intervals (CI). P-values were also provided to compare GMTs between treatment groups adjusted for multiple comparisons according to Tukey-Kramer.||9.6|0.5|0.5969
72469948|NCT01677299|144463849|SUPERIORITY_OR_OTHER||Geo LSmean ratio (Day 5/Baseline)|1.4|||<|0.05|TWO_SIDED|95.0|1.2|1.6|||Mixed Models Analysis|||||1.6|1.2|<0.05
72561807|NCT00578968|144654222|SUPERIORITY_OR_OTHER|||||||0.009||95.0|||||ANOVA|||||||0.009
72561808|NCT00578968|144654223|SUPERIORITY_OR_OTHER|||||||0.005||95.0|||||ANOVA|||||||0.005
72561809|NCT00578968|144654224|SUPERIORITY_OR_OTHER|||||||0.06||95.0|||||ANOVA|||||||0.06
72449403|NCT04800211|144416707|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is equal to zero on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is NOT equal to zero on Visit 5 (Week 6). (mITT Population)|Mean Difference (Net)|-115.256||||0.0003|TWO_SIDED|95.0|-177.973|-52.539|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is equal to zero on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is NOT equal to zero on Visit 5 (Week 6). (mITT Population)||-52.539|-177.973|0.0003
72449404|NCT04800211|144416707|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is NOT equal to zero on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|-74.904||||0.0467|TWO_SIDED|95.0|-148.706|-1.102|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is NOT equal to zero on Visit 7 (Week 12). (mITT Population)||-1.102|-148.706|0.0467
72449405|NCT04800211|144416707|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 2 is equal to zero on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 2 is NOT equal to zero on Visit 5 (Week 6). (mITT Population)|Mean Difference (Net)|-144.035|||<|0.0001|TWO_SIDED|95.0|-206.668|-81.402|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 2 is equal to zero on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 2 is NOT equal to zero on Visit 5 (Week 6). (mITT Population)||-81.402|-206.668|<.0001
72449406|NCT04800211|144416707|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 2 is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 2 is NOT equal to zero on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|-62.755||||0.0807|TWO_SIDED|95.0|-133.221|7.71|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 2 is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 2 is NOT equal to zero on Visit 7 (Week 12). (mITT Population)||7.710|-133.221|0.0807
72449407|NCT04800211|144416707|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 + Test 2 is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 + Test 2 is NOT equal to zero on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|-68.83||||0.0095|TWO_SIDED|95.0|-120.753|-16.907|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 + Test 2 is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 + Test 2 is NOT equal to zero on Visit 7 (Week 12). (mITT Population)||-16.907|-120.753|0.0095
72449408|NCT04800211|144416707|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Control is equal to zero on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Control is NOT equal to zero on Visit 5 (Week 6). (mITT Population)|Mean Difference (Net)|-1.593||||0.9586|TWO_SIDED|95.0|-61.873|58.687|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Control is equal to zero on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Control is NOT equal to zero on Visit 5 (Week 6). (mITT Population)||58.687|-61.873|0.9586
72469596|NCT03635086|144463042|OTHER||Geometric Mean Ratio Estimate|0.3||||0.2043|TWO_SIDED|95.0|0.1|1.4|||Tukey-Kramer|||GMT ratios were estimated by applying an analysis of variance (ANOVA) including the factor treatment group. This was done using log10 transformed data and taking the anti-log of the resulting point estimates for the least squares means, least squares means differences and the corresponding 2-sided 95% confidence intervals (CI). P-values were also provided to compare GMTs between treatment groups adjusted for multiple comparisons according to Tukey-Kramer.||1.4|0.1|0.2043
72469949|NCT01677299|144463849|SUPERIORITY_OR_OTHER||Geo LSmean ratio (Day 5/Baseline)|1.5|||<|0.05|TWO_SIDED|95.0|1.3|1.6|||Mixed Models Analysis|||||1.6|1.3|<0.05
72469950|NCT01677299|144463849|SUPERIORITY_OR_OTHER||Geo LSmean ratio (Day 5/Baseline)|1.5|||<|0.05|TWO_SIDED|95.0|1.4|1.6|||Mixed Models Analysis|||||1.6|1.4|<0.05
72561810|NCT00578968|144654225|SUPERIORITY_OR_OTHER|||||||0.003||95.0|||||ANOVA|||||||0.003
72561811|NCT00578968|144654226|SUPERIORITY_OR_OTHER|||||||0.6||95.0|||||ANOVA|||||||0.60
72561812|NCT00578968|144654227|SUPERIORITY_OR_OTHER|||||||0.35||95.0|||||ANOVA|||||||0.35
72449409|NCT04800211|144416707|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Control is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Control is NOT equal to zero on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|-2.635||||0.9402|TWO_SIDED|95.0|-71.714|66.443|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Control is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Control is NOT equal to zero on Visit 7 (Week 12). (mITT Population)||66.443|-71.714|0.9402
72449410|NCT04800211|144416707|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is equal to Control on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is NOT equal to Control on Visit 5 (Week 6). (mITT Population)|Mean Difference (Net)|-113.663||||0.039|TWO_SIDED|95.0|-223.33|-3.996|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is equal to Control on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is NOT equal to Control on Visit 5 (Week 6). (mITT Population)||-3.996|-223.330|0.0390
72449411|NCT04800211|144416707|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|-72.269||||0.4543|TWO_SIDED|95.0|-199.091|54.554|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)||54.554|-199.091|0.4543
72449412|NCT04800211|144416707|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 2 is equal to Control on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 2 is NOT equal to Control on Visit 5 (Week 6). (mITT Population)|Mean Difference (Net)|-142.442||||0.0051|TWO_SIDED|95.0|-252.08|-32.805|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 2 is equal to Control on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 2 is NOT equal to Control on Visit 5 (Week 6). (mITT Population)||-32.805|-252.080|0.0051
72449413|NCT04800211|144416707|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|-60.12||||0.6061|TWO_SIDED|95.0|-184.286|64.046|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)||64.046|-184.286|0.6061
72449414|NCT04800211|144416707|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 + Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 + Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|-66.194||||0.1242|TWO_SIDED|95.0|-150.672|18.284|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 + Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 + Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)||18.284|-150.672|0.1242
72469597|NCT03635086|144463042|OTHER||Geometric Mean Ratio Estimate|1.5||||0.9388|TWO_SIDED|95.0|0.3|7.4|||Tukey-Kramer|||GMT ratios were estimated by applying an analysis of variance (ANOVA) including the factor treatment group. This was done using log10 transformed data and taking the anti-log of the resulting point estimates for the least squares means, least squares means differences and the corresponding 2-sided 95% confidence intervals (CI). P-values were also provided to compare GMTs between treatment groups adjusted for multiple comparisons according to Tukey-Kramer.||7.4|0.3|0.9388
72370220|NCT00486291|144250964|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.16||0.0007|TWO_SIDED|95.0|-0.9|-0.2|||ANCOVA|||It is anticipated that the pooled standard deviation (SD) of the change from baseline in HbA1c will be between 1.0 and 1.5. With 90 subjects per treatment group the study will have 90% power (two-sided alpha=0.05) to detect a mean difference between groups of 0.486 for SD=1.0, and a mean difference between groups of 0.729 for SD=1.5.||-0.2|-0.9|0.0007
72561813|NCT00578968|144654228|SUPERIORITY_OR_OTHER|||||||0.65||95.0|||||ANOVA|||||||0.65
72561814|NCT00578968|144654229|SUPERIORITY_OR_OTHER|||||||0.43||95.0|||||ANOVA|||||||0.43
72449415|NCT04800211|144416707|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is equal to Test 2 on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is NOT equal to Test 2 on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|-12.149||||0.8117|TWO_SIDED|95.0|-112.35|88.052|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is equal to Test 2 on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is NOT equal to Test 2 on Visit 7 (Week 12). (mITT Population)||88.052|-112.350|0.8117
72449416|NCT04800211|144416708|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-111.957||||0.0567|TWO_SIDED|95.0|-227.151|3.237|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||3.237|-227.151|0.0567
72449417|NCT04800211|144416708|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-76.728||||0.2103|TWO_SIDED|95.0|-197.025|43.569|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||43.569|-197.025|0.2103
72449418|NCT04800211|144416708|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-169.735||||0.0052|TWO_SIDED|95.0|-288.22|-51.251|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||-51.251|-288.220|0.0052
72469598|NCT03635086|144463042|OTHER||Geometric Mean Ratio Estimate|5.2||||0.0251|TWO_SIDED|95.0|1.2|23.1|||Tukey-Kramer|||GMT ratios were estimated by applying an analysis of variance (ANOVA) including the factor treatment group. This was done using log10 transformed data and taking the anti-log of the resulting point estimates for the least squares means, least squares means differences and the corresponding 2-sided 95% confidence intervals (CI). P-values were also provided to compare GMTs between treatment groups adjusted for multiple comparisons according to Tukey-Kramer.||23.1|1.2|0.0251
72469599|NCT03635086|144463045|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups|Geometric Mean Ratio Estimate|0.6||||0.5263|TWO_SIDED|95.0|0.2|1.6|||ANOVA|||Day 0||1.6|0.2|0.5263
72561815|NCT00578968|144654230|SUPERIORITY_OR_OTHER|||||||0.73||95.0|||||ANOVA|||Comparison was made between groups at pretreatment resting time period.||||0.73
72561816|NCT00578968|144654230|SUPERIORITY_OR_OTHER|||||||0.11||95.0|||||ANOVA|||Comparison was made between groups at pretreatment peak exercise time period.||||0.11
72561817|NCT00578968|144654231|SUPERIORITY_OR_OTHER|||||||0.22||95.0|||||ANOVA|||||||0.22
72370221|NCT00486291|144250965|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.5|STANDARD_ERROR_OF_MEAN|0.81|<|0.0001|TWO_SIDED|95.0|-8.1|-4.9|||ANCOVA|||||-4.9|-8.1|<0.0001
72561818|NCT00578968|144654232|SUPERIORITY_OR_OTHER|||||||0.06||95.0|||||ANOVA|||||||0.06
72561819|NCT00578968|144654233|SUPERIORITY_OR_OTHER|||||||0.09||95.0|||||ANOVA|||||||0.09
72561820|NCT00578968|144654234|SUPERIORITY_OR_OTHER|||||||0.04||95.0|||||ANOVA|||||||0.04
72561821|NCT00578968|144654235|SUPERIORITY_OR_OTHER|||||||0.04||95.0|||||ANOVA|||||||0.04
72561822|NCT00578968|144654236|SUPERIORITY_OR_OTHER|||||||0.19||95.0|||||ANOVA|||||||0.19
72561823|NCT00578968|144654237|SUPERIORITY_OR_OTHER|||||||0.16||95.0|||||ANOVA|||||||0.16
72561824|NCT00578968|144654238|SUPERIORITY_OR_OTHER|||||||0.04||95.0|||||ANOVA|||||||0.04
72561825|NCT00603564|144654242|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||endpoint was analyzed in terms of time by comparison of mean +- SD||||<0.001
72561826|NCT00603564|144654243|SUPERIORITY_OR_OTHER|||||||7e-06||95.0|||||Chi-squared|||||||0.000007
72449419|NCT04800211|144416708|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 2 is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 2 is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-52.505||||0.349|TWO_SIDED|95.0|-162.721|57.711|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 2 is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 2 is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||57.711|-162.721|0.3490
72449420|NCT04800211|144416708|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 2 is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 2 is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-11.413||||0.841|TWO_SIDED|95.0|-123.333|100.507|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 2 is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 2 is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||100.507|-123.333|0.8410
72449421|NCT04800211|144416708|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test2 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test2 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-53.565||||0.3465|TWO_SIDED|95.0|-165.4|58.27|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test2 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test2 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||58.270|-165.400|0.3465
72449422|NCT04800211|144416708|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 + Test 2 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 + Test 2 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-111.65||||0.0087|TWO_SIDED|95.0|-194.865|-28.435|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 + Test 2 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 + Test 2 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||-28.435|-194.865|0.0087
72469600|NCT03635086|144463045|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment.|Geometric Mean Ratio Estimate|1.0||||1|TWO_SIDED|95.0|0.4|2.8|||ANOVA|||Day 0||2.8|0.4|1.0000
72469601|NCT03635086|144463045|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment.|Geometric Mean Ratio Estimate|1.0||||1|TWO_SIDED|95.0|0.4|2.7|||ANOVA|||Day 0||2.7|0.4|1.0000
72469602|NCT03635086|144463045|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|1.0||||1|TWO_SIDED|95.0|0.4|2.7|||ANOVA|||Day 0||2.7|0.4|1.0000
72469603|NCT03635086|144463045|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment.|Geometric Mean Ratio Estimate|1.7||||0.55|TWO_SIDED|95.0|0.6|4.7|||ANOVA|||Day 0||4.7|0.6|0.5500
72561827|NCT01350934|144654254|SUPERIORITY_OR_OTHER_LEGACY||Estimated Difference|1.95|STANDARD_ERROR_OF_MEAN|0.56|<|0.001|TWO_SIDED|95.0|0.8|3.1|||Longitudinal data analysis|||||3.1|0.8|<0.001
72561828|NCT01350934|144654255|SUPERIORITY_OR_OTHER_LEGACY||Estimated Difference|2.92|STANDARD_ERROR_OF_MEAN|0.59|<|0.001|TWO_SIDED|95.0|1.8|4.1|||Longitudinal data analysis|||||4.1|1.8|<0.001
72561829|NCT01350934|144654256|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-42.37|||<|0.001|TWO_SIDED|95.0|-48.16|-36.67|||Constrained longitudinal data analysis|||||-36.67|-48.16|<0.001
72561830|NCT01350934|144654257|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-52.03|||<|0.001|TWO_SIDED|95.0|-59.04|-45.3|||Constrained longitudinal data analysis|||||-45.30|-59.04|<0.001
72561831|NCT01350934|144654258|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-51.07|||<|0.001|TWO_SIDED|95.0|-57.29|-44.99|||Constrained longitudinal data analysis|||||-44.99|-57.29|<0.001
72561832|NCT01350934|144654259|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-51.96|||<|0.001|TWO_SIDED|95.0|-58.77|-45.39|||Constrained longitudinal data analysis|||||-45.39|-58.77|<0.001
72561833|NCT01350934|144654260|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.0279|||<|0.001|TWO_SIDED|95.0|0.0074|0.1048|||Cochran-Mantel-Haenszel|||Odds Ratio comparison of percentage of participants with \<20 ng/mL of serum 25-hydroxyvitamin (OH) D between Fosamax Plus group and Calcitriol group.||0.1048|0.0074|<0.001
72449423|NCT04800211|144416708|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Control is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Control is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|63.944||||0.2688|TWO_SIDED|95.0|-49.678|177.565|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Control is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Control is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||177.565|-49.678|0.2688
72449424|NCT04800211|144416708|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Control is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Control is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|151.222||||0.0096|TWO_SIDED|95.0|37.114|265.33|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Control is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Control is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||265.330|37.114|0.0096
72561834|NCT01196117|144654262|SUPERIORITY|||||||0.0009|||||||Wilcoxon (Mann-Whitney)|||||||0.0009
72449425|NCT04800211|144416708|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Control is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Control is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|182.631||||0.0023|TWO_SIDED|95.0|65.754|299.509|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Control is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Control is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||299.509|65.754|0.0023
72449426|NCT04800211|144416708|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is NOT equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-175.901||||0.1612|TWO_SIDED|95.0|-390.865|39.063|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is NOT equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||39.063|-390.865|0.1612
72469604|NCT03635086|144463045|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment.|Geometric Mean Ratio Estimate|1.7||||0.5263|TWO_SIDED|95.0|0.6|4.6|||ANOVA|||Day 0||4.6|0.6|0.5263
72469605|NCT03635086|144463045|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|1.7||||0.5263|TWO_SIDED|95.0|0.6|4.6|||ANOVA|||Day 0||4.6|0.6|0.5263
72469606|NCT03635086|144463045|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|1.0||||1|TWO_SIDED|95.0|0.4|2.8|||ANOVA|||Day 0||2.8|0.4|1.0000
72469607|NCT03635086|144463045|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|1.0||||1|TWO_SIDED|95.0|0.4|2.8|||ANOVA|||Day 0||2.8|0.4|1.0000
72469608|NCT03635086|144463045|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|1.0||||1|TWO_SIDED|95.0|0.4|2.7|||ANOVA|||Day 0||2.7|0.4|1.0000
72561835|NCT01196117|144654263|SUPERIORITY|||||||0.8938|||||||Wilcoxon (Mann-Whitney)|||||||0.8938
72561836|NCT01196117|144654264|SUPERIORITY||||||<|0.014|||||||Wilcoxon (Mann-Whitney)|||||||<0.014
72561837|NCT01196117|144654265|SUPERIORITY||||||<|0.02|||||||Wilcoxon (Mann-Whitney)|||||||<0.0200
72561838|NCT01196117|144654266|SUPERIORITY|||||||0.1321|||||||Wilcoxon (Mann-Whitney)|||||||0.1321
72561839|NCT01196117|144654267|SUPERIORITY||||||<|0.249|||||||Wilcoxon (Mann-Whitney)|||||||<0.2490
72561840|NCT01196117|144654268|SUPERIORITY|||||||0.5139|||||||Wilcoxon (Mann-Whitney)|||||||0.5139
72561841|NCT01196117|144654269|SUPERIORITY|||||||0.0597|||||||Wilcoxon (Mann-Whitney)|||||||0.0597
72561842|NCT01196117|144654270|SUPERIORITY|||||||0.2134|||||||Wilcoxon (Mann-Whitney)|||||||0.2134
72561843|NCT00493792|144654281|SUPERIORITY||Hazard Ratio (HR)|0.72||||0.47|TWO_SIDED|95.0|0.29|1.77|||Regression, Cox|||||1.77|0.29|0.47
72561844|NCT00493792|144654282|SUPERIORITY||Hazard Ratio (HR)|0.49||||0.06|TWO_SIDED|95.0|0.23|1.03|||Regression, Cox|||||1.03|0.23|0.06
72449427|NCT04800211|144416708|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is NOT equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-227.95||||0.0396|TWO_SIDED|95.0|-448.725|-7.175|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is NOT equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||-7.175|-448.725|0.0396
72449428|NCT04800211|144416708|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-352.366||||0.0002|TWO_SIDED|95.0|-573.315|-131.418|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||-131.418|-573.315|0.0002
72449429|NCT04800211|144416708|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 2 is equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 2 is NOT equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-116.449||||0.5616|TWO_SIDED|95.0|-327.445|94.547|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 2 is equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 2 is NOT equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||94.547|-327.445|0.5616
72449430|NCT04800211|144416708|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 2 is equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 2 is NOT equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-162.635||||0.2176|TWO_SIDED|95.0|-375.57|50.299|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 2 is equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 2 is NOT equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||50.299|-375.570|0.2176
72449431|NCT04800211|144416708|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 2 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 2 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-236.196||||0.0242|TWO_SIDED|95.0|-451.334|-21.059|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 2 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 2 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||-21.059|-451.334|0.0242
72469609|NCT03635086|144463045|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|0.5||||0.5321|TWO_SIDED|95.0|0.2|1.7|||ANOVA|||Day 28||1.7|0.2|0.5321
72469610|NCT03635086|144463045|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|1.1||||0.9983|TWO_SIDED|95.0|0.3|3.9|||ANOVA|||Day 28||3.9|0.3|0.9983
72469611|NCT03635086|144463045|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|0.6||||0.8234|TWO_SIDED|95.0|0.2|2.1|||ANOVA|||Day 28||2.1|0.2|0.8234
72469612|NCT03635086|144463045|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|0.8||||0.9882|TWO_SIDED|95.0|0.2|2.7|||ANOVA|||Day 28||2.7|0.2|0.9882
72469613|NCT03635086|144463045|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|2.2||||0.3778|TWO_SIDED|95.0|0.6|7.6|||ANOVA|||Day 28||7.6|0.6|0.3778
72449432|NCT04800211|144416708|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 + Test 2 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 + Test 2 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-294.281|||<|0.0001|TWO_SIDED|95.0|-434.513|-154.05|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 + Test 2 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 + Test 2 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||-154.050|-434.513|<.0001
72561845|NCT00493792|144654283|SUPERIORITY||Hazard Ratio (HR)|0.73||||0.193|TWO_SIDED|95.0|0.45|1.18|||Regression, Cox|||||1.18|.45|0.193
72449433|NCT04800211|144416708|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 2 is equal to Test 1 on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 2 is NOT equal to Test 1 on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-116.17||||0.1524|TWO_SIDED|95.0|-275.521|43.18|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 2 is equal to Test 1 on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 2 is NOT equal to Test 1 on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||43.180|-275.521|0.1524
72449434|NCT04800211|144416709|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 is equal to zero on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 is NOT equal to zero on Visit 5 (Week 6). (mITT Population)|Mean Difference (Net)|-32.792|||<|0.0001|TWO_SIDED|95.0|-39.375|-26.208|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 is equal to zero on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 is NOT equal to zero on Visit 5 (Week 6). (mITT Population)||-26.208|-39.375|<.0001
72449435|NCT04800211|144416709|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 is NOT equal to zero on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|-25.921|||<|0.0001|TWO_SIDED|95.0|-33.398|-18.443|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 is NOT equal to zero on Visit 7 (Week 12). (mITT Population)||-18.443|-33.398|<.0001
72449436|NCT04800211|144416709|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 2 is equal to zero on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 2 is NOT equal to zero on Visit 5 (Week 6). (mITT Population)|Mean Difference (Net)|-25.484|||<|0.0001|TWO_SIDED|95.0|-31.99|-18.979|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 2 is equal to zero on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 2 is NOT equal to zero on Visit 5 (Week 6). (mITT Population)||-18.979|-31.990|<.0001
72469614|NCT03635086|144463045|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|1.2||||0.9878|TWO_SIDED|95.0|0.4|4.1|||ANOVA|||Day 28||4.1|0.4|0.9878
72469615|NCT03635086|144463045|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|1.6||||0.8213|TWO_SIDED|95.0|0.5|5.3|||ANOVA|||Day 28||5.3|0.5|0.8213
72469616|NCT03635086|144463045|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|0.6||||0.6716|TWO_SIDED|95.0|0.2|1.9|||ANOVA|||Day 28||1.9|0.2|0.6716
72469617|NCT03635086|144463045|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|0.7||||0.938|TWO_SIDED|95.0|0.2|2.5|||ANOVA|||Day 28||2.5|0.2|0.9380
72469618|NCT03635086|144463045|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|1.3||||0.9777|TWO_SIDED|95.0|0.4|4.3|||ANOVA|||Day 28||4.3|0.4|0.9777
72561846|NCT00685035|144654289|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.23|STANDARD_DEVIATION|0.23||0.02|TWO_SIDED|95.0|||||ANCOVA|||||||.02
72622407|NCT04439903|144774780|OTHER||Slope|-0.68016|STANDARD_ERROR_OF_MEAN|1.0084||0.5128|TWO_SIDED||||||Regression, Linear||Predictor variable 1: Number of simulations per participant per week.|||||0.5128
72622408|NCT04439903|144774780|OTHER||Slope|0.15238|STANDARD_ERROR_OF_MEAN|0.3629||0.68197|TWO_SIDED||||||Regression, Linear||Predictor variable 2: Minutes of interaction with the Web-Based Simulation Tool per participant per week.|||||0.68197
72622409|NCT04439903|144774781|OTHER||Intercept|-0.49527|STANDARD_ERROR_OF_MEAN|0.44535||0.28789|TWO_SIDED||||||Regression, Linear|||||||0.28789
72449437|NCT04800211|144416709|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 2 is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 2 is NOT equal to zero on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|-26.899|||<|0.0001|TWO_SIDED|95.0|-34.135|-19.663|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 2 is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 2 is NOT equal to zero on Visit 7 (Week 12). (mITT Population)||-19.663|-34.135|<.0001
72449438|NCT04800211|144416709|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 + Test 2 is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 + Test 2 is NOT equal to zero on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|-26.41|||<|0.0001|TWO_SIDED|95.0|-31.716|-21.103|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 + Test 2 is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 + Test 2 is NOT equal to zero on Visit 7 (Week 12). (mITT Population)||-21.103|-31.716|<.0001
72449439|NCT04800211|144416709|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Control is equal to zero on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Control is NOT equal to zero on Visit 5 (Week 6). (mITT Population)|Mean Difference (Net)|-7.021||||0.028|TWO_SIDED|95.0|-13.278|-0.763|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Control is equal to zero on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Control is NOT equal to zero on Visit 5 (Week 6). (mITT Population)||-0.763|-13.278|0.0280
72449440|NCT04800211|144416709|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Control is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Control is NOT equal to zero on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|-5.902||||0.0972|TWO_SIDED|95.0|-12.881|1.077|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Control is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Control is NOT equal to zero on Visit 7 (Week 12). (mITT Population)||1.077|-12.881|0.0972
72449441|NCT04800211|144416709|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 is equal to Control on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 is NOT equal to Control on Visit 5 (Week 6). (mITT Population)|Mean Difference (Net)|-25.771|||<|0.0001|TWO_SIDED|95.0|-37.189|-14.353|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 is equal to Control on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 is NOT equal to Control on Visit 5 (Week 6). (mITT Population)||-14.353|-37.189|<.0001
72449442|NCT04800211|144416709|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|-20.019||||0.0005|TWO_SIDED|95.0|-32.833|-7.205|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)||-7.205|-32.833|0.0005
72449443|NCT04800211|144416709|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 2 is equal to Control on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 2 is NOT equal to Control on Visit 5 (Week 6). (mITT Population)|Mean Difference (Net)|-18.463||||0.0002|TWO_SIDED|95.0|-29.825|-7.101|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 2 is equal to Control on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 2 is NOT equal to Control on Visit 5 (Week 6). (mITT Population)||-7.101|-29.825|0.0002
72469619|NCT03635086|144463045|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|1.1||||0.9997|TWO_SIDED|95.0|0.3|4.7|||ANOVA|||Day 56||4.7|0.3|0.9997
72622410|NCT04439903|144774781|OTHER||Slope|0.16785|STANDARD_ERROR_OF_MEAN|0.11745||0.17848|TWO_SIDED||||||Regression, Linear||Predictor variable 1: Number of simulations per participant per week.|||||0.17848
72622411|NCT04439903|144774781|OTHER||Slope|-0.06091|STANDARD_ERROR_OF_MEAN|0.042266||0.17514|TWO_SIDED||||||Regression, Linear||Predictor variable 2: Minutes of interaction with the Web-Based Simulation Tool per participant per week.|||||0.17514
72622412|NCT04439903|144774782|OTHER||Intercept|-0.28825|STANDARD_ERROR_OF_MEAN|0.59949||0.63929|TWO_SIDED||||||Regression, Linear|||||||0.63929
72561847|NCT04241133|144654293|OTHER|The experimental and control groups were not compared due to the inability to collect post data with the control group because of stay at home orders during the COVID-19 pandemic.|||||<|0.05||||||The reported P-value was calculated.|t-test, 2 sided|The a priori threshold for statistical significance was P\<0.05.||The experimental group was tested for significant difference in Healthy Eating Index 2015 (HEI-2015) scores at baseline and 12 weeks. SAS macros provided by the National Cancer Institute were used to compute HEI-2015 scores for each dietary recall at pre- (baseline) and post-intervention (12 weeks) using the Simple HEI Scoring Algorithm.||||<0.05
72622413|NCT04439903|144774782|OTHER||Slope|-0.14422|STANDARD_ERROR_OF_MEAN|0.1581||0.37964|TWO_SIDED||||||Regression, Linear||Predictor variable 1: Number of simulations per participant per week.|||||0.37964
72622414|NCT04439903|144774782|OTHER||Slope|0.06718|STANDARD_ERROR_OF_MEAN|0.056895||0.26057|TWO_SIDED||||||Regression, Linear||Predictor variable 2: Minutes of interaction with the Web-Based Simulation Tool per participant per week.|||||0.26057
72449444|NCT04800211|144416709|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|-20.997||||0.0002|TWO_SIDED|95.0|-33.619|-8.375|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)||-8.375|-33.619|0.0002
72449445|NCT04800211|144416709|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 + Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 + Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|-20.508|||<|0.0001|TWO_SIDED|95.0|-29.061|-11.955|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 + Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 + Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)||-11.955|-29.061|<.0001
72449446|NCT04800211|144416709|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 is equal to Test 2 on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 is NOT equal to Test 2 on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|0.978||||0.8504|TWO_SIDED|95.0|-9.216|11.172|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 is equal to Test 2 on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 is NOT equal to Test 2 on Visit 7 (Week 12). (mITT Population)||11.172|-9.216|0.8504
72469620|NCT03635086|144463045|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|1.5||||0.9287|TWO_SIDED|95.0|0.3|7.2|||ANOVA|||Day 56||7.2|0.3|0.9287
72469621|NCT03635086|144463045|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|0.5||||0.5598|TWO_SIDED|95.0|0.1|2.0|||ANOVA|||Day 56||2.0|0.1|0.5598
72469622|NCT03635086|144463045|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment.|Geometric Mean Ratio Estimate|3.0||||0.2117|TWO_SIDED|95.0|0.7|13.1|||ANOVA|||Day 56||13.1|0.7|0.2117
72469623|NCT03635086|144463045|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|1.4||||0.9699|TWO_SIDED|95.0|0.3|6.6|||ANOVA|||Day 56||6.6|0.3|0.9699
72469624|NCT03635086|144463045|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|0.4||||0.446|TWO_SIDED|95.0|0.1|1.8|||ANOVA|||Day 56||1.8|0.1|0.4460
72469625|NCT03635086|144463045|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|2.8||||0.292|TWO_SIDED|95.0|0.6|11.9|||ANOVA|||Day 56||11.9|0.6|0.2920
72469626|NCT03635086|144463045|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|0.3||||0.184|TWO_SIDED|95.0|0.1|1.4|||ANOVA|||Day 56||1.4|0.1|0.1840
72469627|NCT03635086|144463045|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|2.0||||0.7229|TWO_SIDED|95.0|0.4|9.2|||ANOVA|||Day 56||9.2|0.4|0.7229
72469628|NCT03635086|144463045|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|6.6||||0.0052|TWO_SIDED|95.0|1.5|28.6|||ANOVA|||Day 56||28.6|1.5|0.0052
72469629|NCT03635086|144463045|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|0.8||||0.9777|TWO_SIDED|95.0|0.2|3.0|||ANOVA|||Day 182||3.0|0.2|0.9777
72469630|NCT03635086|144463045|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|1.3||||0.9812|TWO_SIDED|95.0|0.3|5.3|||ANOVA|||Day 182||5.3|0.3|0.9812
72469631|NCT03635086|144463045|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|1.2||||0.9979|TWO_SIDED|95.0|0.3|4.5|||ANOVA|||Day 182||4.5|0.3|0.9979
72469632|NCT03635086|144463045|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|2.0||||0.588|TWO_SIDED|95.0|0.5|7.9|||ANOVA|||Day 182||7.9|0.5|0.5880
72469633|NCT03635086|144463045|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|1.7||||0.7973|TWO_SIDED|95.0|0.4|7.0|||ANOVA|||Day 182||7.0|0.4|0.7973
72449447|NCT04800211|144416710|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Plasma sICAM-1 (ng/mL) in Test 1 is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-31.257|||<|0.0001|TWO_SIDED|95.0|-41.957|-20.557|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Plasma sICAM-1 (ng/mL) in Test 1 is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||-20.557|-41.957|<.0001
72449448|NCT04800211|144416710|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Plasma sICAM-1 (ng/mL) in Test 1 is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-29.862|||<|0.0001|TWO_SIDED|95.0|-44.234|-15.491|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Plasma sICAM-1 (ng/mL) in Test 1 is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||-15.491|-44.234|<.0001
72449449|NCT04800211|144416710|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Plasma sICAM-1 (ng/mL) in Test 1 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-31.512|||<|0.0001|TWO_SIDED|95.0|-46.971|-16.053|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Plasma sICAM-1 (ng/mL) in Test 1 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||-16.053|-46.971|<.0001
72449450|NCT04800211|144416710|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Plasma sICAM-1 (ng/mL) in Test 2 is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 2 is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-37.197|||<|0.0001|TWO_SIDED|95.0|-47.522|-26.872|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Plasma sICAM-1 (ng/mL) in Test 2 is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 2 is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||-26.872|-47.522|<.0001
72449451|NCT04800211|144416710|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Plasma sICAM-1 (ng/mL) in Test 2 is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 2 is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-31.442|||<|0.0001|TWO_SIDED|95.0|-44.96|-17.923|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Plasma sICAM-1 (ng/mL) in Test 2 is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 2 is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||-17.923|-44.960|<.0001
72449452|NCT04800211|144416710|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Plasma sICAM-1 (ng/mL) in Test2 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test2 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-28.597||||0.0002|TWO_SIDED|95.0|-43.34|-13.853|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Plasma sICAM-1 (ng/mL) in Test2 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test2 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||-13.853|-43.340|0.0002
72498819|NCT01817790|144527880|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-0.15||||0.0005||95.0|-0.23|-0.06||p-value was not adjusted for multiple comparisons.|ANCOVA|Linear Fixed-effect Model; Treatment and site as fixed factors and baseline score as covariate.||Null hypothesis was that no difference exists in the mean change from baseline in PM reflective symptom scores for Eye itching/burning between the Fluticasone nasal spray and the placebo nasal spray.||-0.06|-0.23|0.0005
72449453|NCT04800211|144416710|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Plasma sICAM-1 (ng/mL) in Test 1 + Test 2 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 + Test 2 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-30.054|||<|0.0001|TWO_SIDED|95.0|-40.943|-19.166|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Plasma sICAM-1 (ng/mL) in Test 1 + Test 2 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 + Test 2 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||-19.166|-40.943|<.0001
72449454|NCT04800211|144416710|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Plasma sICAM-1 (ng/mL) in Control is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Control is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-5.904||||0.2667|TWO_SIDED|95.0|-16.37|4.563|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Plasma sICAM-1 (ng/mL) in Control is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Control is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||4.563|-16.370|0.2667
72449455|NCT04800211|144416710|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Plasma sICAM-1 (ng/mL) in Control is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Control is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|8.767||||0.2085|TWO_SIDED|95.0|-4.95|22.485|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Plasma sICAM-1 (ng/mL) in Control is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Control is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||22.485|-4.950|0.2085
72449456|NCT04800211|144416710|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Plasma sICAM-1 (ng/mL) in Control is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Control is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|12.455||||0.1041|TWO_SIDED|95.0|-2.595|27.505|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Plasma sICAM-1 (ng/mL) in Control is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Control is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||27.505|-2.595|0.1041
72449457|NCT04800211|144416710|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Plasma sICAM-1 (ng/mL) in Test 1 is equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 is NOT equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-25.353||||0.0058|TWO_SIDED|95.0|-45.41|-5.295|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Plasma sICAM-1 (ng/mL) in Test 1 is equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 is NOT equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||-5.295|-45.410|0.0058
72449458|NCT04800211|144416710|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Plasma sICAM-1 (ng/mL) in Test 1 is equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 is NOT equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-38.63||||0.001|TWO_SIDED|95.0|-65.062|-12.197|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Plasma sICAM-1 (ng/mL) in Test 1 is equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 is NOT equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||-12.197|-65.062|0.0010
72469634|NCT03635086|144463045|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|1.5||||0.8992|TWO_SIDED|95.0|0.4|6.0|||ANOVA|||Day 182||6.0|0.4|0.8992
72469635|NCT03635086|144463045|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|2.7||||0.2602|TWO_SIDED|95.0|0.7|10.4|||ANOVA|||Day 182||10.4|0.7|0.2602
72561848|NCT01067521|144654415|SUPERIORITY||Risk Ratio (RR)|0.656|STANDARD_ERROR_OF_MEAN|0.066|<|0.0001|TWO_SIDED|95.0|0.539|0.799||The overall significance level for this study is 5%|Negative Binomial Regression||GA 40 mg vs. placebo|"Relapses were estimated by a baseline-adjusted, Negative Binomial Regression with an offset based on the log of subject's exposure to treatment. The model included the following covariates: - Baseline EDSS score. - Log of the prior 2-year number of relapses. - Volume of T2 lesions at baseliner. - Status of Gd-enhancing T1 activity at baseline (=0 no Gd-enhancing T1 at baseline; =1 at least one Gd-enhancing T1 at baseline). - CGR."||0.799|0.539|<0.0001
72449459|NCT04800211|144416710|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Plasma sICAM-1 (ng/mL) in Test 1 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-43.967||||0.0005|TWO_SIDED|95.0|-72.443|-15.491|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Plasma sICAM-1 (ng/mL) in Test 1 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||-15.491|-72.443|0.0005
72449460|NCT04800211|144416710|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Plasma sICAM-1 (ng/mL) in Test 2 is equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 2 is NOT equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-31.293||||0.0003|TWO_SIDED|95.0|-51.159|-11.428|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Plasma sICAM-1 (ng/mL) in Test 2 is equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 2 is NOT equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||-11.428|-51.159|0.0003
72449461|NCT04800211|144416710|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Plasma sICAM-1 (ng/mL) in Test 2 is equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 2 is NOT equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-40.209||||0.0004|TWO_SIDED|95.0|-65.941|-14.477|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Plasma sICAM-1 (ng/mL) in Test 2 is equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 2 is NOT equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||-14.477|-65.941|0.0004
72449462|NCT04800211|144416710|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Plasma sICAM-1 (ng/mL) in Test 2 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 2 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-41.052||||0.0011|TWO_SIDED|95.0|-68.965|-13.138|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Plasma sICAM-1 (ng/mL) in Test 2 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 2 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||-13.138|-68.965|0.0011
72469636|NCT03635086|144463045|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|0.9||||0.9991|TWO_SIDED|95.0|0.2|3.6|||ANOVA|||Day 182||3.6|0.2|0.9991
72561849|NCT01067521|144654416|SUPERIORITY||Risk Ratio (RR)|0.653|STANDARD_ERROR_OF_MEAN|0.059|<|0.0001|TWO_SIDED|95.0|0.546|0.78||The overall significance level for this study is 5%|Negative binomial regression||GA 40 mg vs. placebo|Negative binomial regression||0.780|0.546|<.0001
72561850|NCT01067521|144654417|SUPERIORITY||Risk Ratio (RR)|0.552|STANDARD_ERROR_OF_MEAN|0.066|<|0.0001|TWO_SIDED|95.0|0.436|0.699||The overall significance level for this study is 5%|Negative Binomial Regression||GA 40 mg vs. placebo|||0.699|0.436|<0.0001
72561851|NCT01067521|144654418|SUPERIORITY||Mean Difference (Final Values)|-0.061|STANDARD_ERROR_OF_MEAN|0.048||0.2058|TWO_SIDED|95.0|-0.154|0.033||The overall significance level for this study is 5%|ANCOVA||GA 40 mg vs Placebo|||0.033|-0.154|0.2058
72561852|NCT01067521|144654419|SUPERIORITY||Risk Ratio (RR)|0.8332|STANDARD_ERROR_OF_MEAN|0.0744||0.0409|TWO_SIDED|95.0|0.6995|0.9925||not adjusted for multiplicity|Negative Binomial Regression||Early Start vs Delayed Start|Entire Study The Negative Binomial Regression model covariates: • treatment group • PCBL (Placebo-Controlled Baseline) Kurtzke's Expanded Disability Status Scale (EDSS) score as 1 degree of freedom variable • Log of the # of relapses in the 2 years prior to PCBL • Volume of T2 lesions at PCBL • Status of Gd-enhancing T1 lesion activity at PCBL (=0 if no Gd-enhancing T1 lesions at PCBL; =1 if at least one Gd-enhancing T1 lesion at PCBL) • Country or Geographical Region (CGR)||0.9925|0.6995|0.0409
72370222|NCT01056016|144250973|SUPERIORITY_OR_OTHER||Mean Difference (Net)|32.4|||=|0.003|TWO_SIDED||||||t-test, 2 sided|||The percentage of patients with whom pediatrician in each group utilized each practice behavior at baseline and 6-months was computed. The reported statistical analysis did not account potential clustering due to the small number of practices in this study.||||=.003
72449463|NCT04800211|144416710|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Plasma sICAM-1 (ng/mL) in Test 1 + Test 2 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 + Test 2 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-42.509|||<|0.0001|TWO_SIDED|95.0|-60.902|-24.116|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Plasma sICAM-1 (ng/mL) in Test 1 + Test 2 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 + Test 2 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||-24.116|-60.902|<.0001
72449464|NCT04800211|144416710|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Plasma sICAM-1 (ng/mL) in Test 2 is equal to Test 1 on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 2 is NOT equal to Test 1 on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-2.915||||0.7835|TWO_SIDED|95.0|-23.855|18.025|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Plasma sICAM-1 (ng/mL) in Test 2 is equal to Test 1 on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 2 is NOT equal to Test 1 on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||18.025|-23.855|0.7835
72449465|NCT04800211|144416711|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Whole Blood WBC (x 10\^3/uL) in Test 1 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood WBC (x 10\^3/uL) in Test 1 is NOT equal to Control on Visit 7 (Week 12). (mITT Population with Outliers Excluded)|Mean Difference (Net)|-0.769||||0.0002|TWO_SIDED|95.0|-1.228|-0.309|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Whole Blood WBC (x 10\^3/uL) in Test 1 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood WBC (x 10\^3/uL) in Test 1 is NOT equal to Control on Visit 7 (Week 12). (mITT Population with Outliers Excluded)||-0.309|-1.228|0.0002
72449466|NCT04800211|144416711|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Whole Blood WBC (x 10\^3/uL) in Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood WBC (x 10\^3/uL) in Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population with Outliers Excluded)|Mean Difference (Net)|-0.52||||0.0175|TWO_SIDED|95.0|-0.972|-0.068|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Whole Blood WBC (x 10\^3/uL) in Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood WBC (x 10\^3/uL) in Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population with Outliers Excluded)||-0.068|-0.972|0.0175
72449467|NCT04800211|144416712|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 is NOT equal to Control on Visit 7 (Week 12). (mITT Population with Outliers Excluded)|Mean Difference (Net)|2.408||||0.0362|TWO_SIDED|95.0|0.11|4.705|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 is NOT equal to Control on Visit 7 (Week 12). (mITT Population with Outliers Excluded)||4.705|0.110|0.0362
72469637|NCT03635086|144463045|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|1.5||||0.9028|TWO_SIDED|95.0|0.4|6.2|||ANOVA|||Day 182||6.2|0.4|0.9028
72469638|NCT03635086|144463045|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|1.7||||0.7761|TWO_SIDED|95.0|0.4|6.8|||ANOVA|||Day 182||6.8|0.4|0.7761
72469639|NCT03635086|144463045|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|0.6||||0.7833|TWO_SIDED|95.0|0.2|2.1|||ANOVA|||Day 365||2.1|0.2|0.7833
72469640|NCT03635086|144463045|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|0.8||||0.9915|TWO_SIDED|95.0|0.2|2.9|||ANOVA|||Day 365||2.9|0.2|0.9915
72469641|NCT03635086|144463045|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|0.9||||0.998|TWO_SIDED|95.0|0.3|3.0|||ANOVA|||Day 365||3.0|0.3|0.9980
72561853|NCT01067521|144654420|SUPERIORITY||Risk Ratio (RR)|0.736|STANDARD_ERROR_OF_MEAN|0.081||0.0056|TWO_SIDED|95.0|0.592|0.914||not adjusted for multiplicity|Negative binomial regression||Early Start vs Delayed Start|Month 6 Negative binomial regression||0.914|0.592|0.0056
72561854|NCT01067521|144654420|SUPERIORITY||Risk Ratio (RR)|0.633|STANDARD_ERROR_OF_MEAN|0.061|<|0.0001|TWO_SIDED|95.0|0.524|0.765||not adjusted for multiplicity|Negative binomial regression||Early Start vs Delayed Start|Month 12 Negative binomial regression||0.765|0.524|<0.0001
72561855|NCT01067521|144654420|SUPERIORITY||Risk Ratio (RR)|0.666|STANDARD_ERROR_OF_MEAN|0.061|<|0.0001|TWO_SIDED|95.0|0.557|0.797||not adjusted for multiplicity|Negative binomial regression||Early Start vs Delayed Start|Month 36 Negative binomial regression||0.797|0.557|<0.0001
72449468|NCT04800211|144416712|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|1.692||||0.2142|TWO_SIDED|95.0|-0.569|3.953|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)||3.953|-0.569|0.2142
72449469|NCT04800211|144416713|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|-39.501||||0.025|TWO_SIDED|95.0|-75.396|-3.605|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)||-3.605|-75.396|0.0250
72449470|NCT04800211|144416713|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|-2.94||||0.9997|TWO_SIDED|95.0|-37.896|32.016|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)||32.016|-37.896|0.9997
72449471|NCT04800211|144416714|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|-54.398||||0.6778|TWO_SIDED|95.0|-177.281|68.485|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)||68.485|-177.281|0.6778
72449472|NCT04800211|144416714|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|-48.395||||0.7497|TWO_SIDED|95.0|-168.697|71.908|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)||71.908|-168.697|0.7497
72449473|NCT04800211|144416715|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|-20.01||||0.0003|TWO_SIDED|95.0|-32.447|-7.573|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)||-7.573|-32.447|0.0003
72619559|NCT03537729|144769954|SUPERIORITY|Sample size was determined by power analysis for the adjusted wayfinding speed.|Ratio of mean proportions of errors|0.63||||0.03|TWO_SIDED|95.0|0.42|0.94||P-value was not adjusted for multiple comparisons. A priori threshold for statistical significance was .05.|Generalized mixed model analysis|Covariates included baseline value of the outcome, age, sex, and cognition score at baseline, and use of wheelchair on the route.|Ratio of mean proportion of errors for spaced retrieval divided by proportion of errors for cues. Log of the mean was estimated from generalized linear mixed effects models for each arm. The difference between logs of means was exponentiated.|The null hypothesis was that means of two arms on the high complexity route are equal, the alternative was that means were not equal.||0.94|0.42|.03
72498820|NCT01817790|144527881|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-0.13||||0.0023||95.0|-0.22|-0.06||p-value was not adjusted for multiple comparisons.|ANCOVA|||Null hypothesis was that no difference exists in the mean change from baseline in AM reflective symptom scores for Eye Tearing/Watering between the Fluticasone nasal spray and the placebo nasal spray.||-0.06|-0.22|0.0023
72622415|NCT02899754|144774783|SUPERIORITY|||||||0.18|||||||t-test, 2 sided|||Primary outcome assessed at 1 month post-intervention||||0.18
72449474|NCT04800211|144416715|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|-22.566|||<|0.0001|TWO_SIDED|95.0|-34.837|-10.295|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)||-10.295|-34.837|<.0001
72449475|NCT04800211|144416716|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g creatinine) in Test 1 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g creatinine) in Test 1 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|-179.365|||<|0.0001|TWO_SIDED|95.0|-225.708|-133.022|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g creatinine) in Test 1 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g creatinine) in Test 1 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)||-133.022|-225.708|<.0001
72449476|NCT04800211|144416716|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g creatinine) in Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g creatinine) in Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|-153.22|||<|0.0001|TWO_SIDED|95.0|-198.93|-107.509|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g creatinine) in Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g creatinine) in Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)||-107.509|-198.930|<.0001
72449477|NCT04800211|144416717|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|-2.569|||<|0.0001|TWO_SIDED|95.0|-3.084|-2.054|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)||-2.054|-3.084|<.0001
72449478|NCT04800211|144416717|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|-2.586|||<|0.0001|TWO_SIDED|95.0|-3.092|-2.081|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)||-2.081|-3.092|<.0001
72449479|NCT04800211|144416719|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Screening) for Percentage of Predicted FEV1 (%) in Test 1 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Screening) for Percentage of Predicted FEV1 (%) in Test 1 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|1.42||||0.0839|TWO_SIDED|95.0|-0.19|3.04|||ANCOVA||The ANCOVA includes study group, gender, and age class as fixed effects, and baseline score as the covariate. Least-squares means (LS Means) are calculated from the ANCOVA.|Null hypothesis: Absolute change from Baseline (Screening) for Percentage of Predicted FEV1 (%) in Test 1 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Screening) for Percentage of Predicted FEV1 (%) in Test 1 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)||3.04|-0.19|0.0839
72449480|NCT04800211|144416719|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Screening) for Percentage of Predicted FEV1 (%) in Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Screening) for Percentage of Predicted FEV1 (%) in Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|2.1||||0.0089|TWO_SIDED|95.0|0.53|3.66|||ANCOVA||The ANCOVA includes study group, gender, and age class as fixed effects, and baseline score as the covariate. Least-squares means (LS Means) are calculated from the ANCOVA.|Null hypothesis: Absolute change from Baseline (Screening) for Percentage of Predicted FEV1 (%) in Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Screening) for Percentage of Predicted FEV1 (%) in Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)||3.66|0.53|0.0089
72469642|NCT03635086|144463045|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|1.4||||0.909|TWO_SIDED|95.0|0.4|4.9|||ANOVA|||Day 365||4.9|0.4|0.9090
72370223|NCT03051178|144250974|SUPERIORITY||||||<|0.01||||||All post-hoc comparisons were Bonferroni corrected.|ANOVA|||TRS scores measured across different stimulation conditions were assessed using a mixed model ANOVA with the participant as a random effect. All post-hoc comparisons were Bonferroni corrected.||||<0.01
72370224|NCT03001817|144250983|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<0.0001
72449481|NCT04800211|144416720|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Screening) for Percentage of Predicted FVC (%) in Test 1 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Screening) for Percentage of Predicted FVC (%) in Test 1 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|0.26||||0.7101|TWO_SIDED|95.0|-1.13|1.66|||ANCOVA||The ANCOVA includes study group, gender, and age class as fixed effects, and baseline score as the covariate. Least-squares means (LS Means) are calculated from the ANCOVA.|Null hypothesis: Absolute change from Baseline (Screening) for Percentage of Predicted FVC (%) in Test 1 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Screening) for Percentage of Predicted FVC (%) in Test 1 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)||1.66|-1.13|0.7101
72449482|NCT04800211|144416720|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Screening) for Percentage of Predicted FVC (%) in Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Screening) for Percentage of Predicted FVC (%) in Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|0.24||||0.7325|TWO_SIDED|95.0|-1.12|1.59|||ANCOVA||The ANCOVA includes study group, gender, and age class as fixed effects, and baseline score as the covariate. Least-squares means (LS Means) are calculated from the ANCOVA.|Null hypothesis: Absolute change from Baseline (Screening) for Percentage of Predicted FVC (%) in Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Screening) for Percentage of Predicted FVC (%) in Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)||1.59|-1.12|0.7325
72449483|NCT04800211|144416721|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Screening) for Percentage of Predicted FEV1/FVC (%) in Test 1 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Screening) for Percentage of Predicted FEV1/FVC (%) in Test 1 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|1.48||||0.0136|TWO_SIDED|95.0|0.31|2.66|||ANCOVA||The ANCOVA includes study group, gender, and age class as fixed effects, and baseline score as the covariate. Least-squares means (LS Means) are calculated from the ANCOVA.|Null hypothesis: Absolute change from Baseline (Screening) for Percentage of Predicted FEV1/FVC (%) in Test 1 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Screening) for Percentage of Predicted FEV1/FVC (%) in Test 1 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)||2.66|0.31|0.0136
72449484|NCT04800211|144416721|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Screening) for Percentage of Predicted FEV1/FVC (%) in Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Screening) for Percentage of Predicted FEV1/FVC (%) in Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|1.94||||0.0009|TWO_SIDED|95.0|0.8|3.08|||ANCOVA||The ANCOVA includes study group, gender, and age class as fixed effects, and baseline score as the covariate. Least-squares means (LS Means) are calculated from the ANCOVA.|Null hypothesis: Absolute change from Baseline (Screening) for Percentage of Predicted FEV1/FVC (%) in Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Screening) for Percentage of Predicted FEV1/FVC (%) in Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)||3.08|0.80|0.0009
72449485|NCT04800211|144416722|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 is equal to zero on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 is NOT equal to zero on Visit 5 (Week 6). (mITT Population)|Mean Difference (Net)|0.038||||0.9294|TWO_SIDED|95.0|-0.795|0.87|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 is equal to zero on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 is NOT equal to zero on Visit 5 (Week 6). (mITT Population)||0.870|-0.795|0.9294
72449486|NCT04800211|144416722|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 is NOT equal to zero on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|0.277||||0.529|TWO_SIDED|95.0|-0.587|1.142|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 is NOT equal to zero on Visit 7 (Week 12). (mITT Population)||1.142|-0.587|0.5290
72469643|NCT03635086|144463045|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|1.3||||0.9651|TWO_SIDED|95.0|0.4|4.7|||ANOVA|||Day 365||4.7|0.4|0.9651
72469644|NCT03635086|144463045|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|1.4||||0.9112|TWO_SIDED|95.0|0.4|4.7|||ANOVA|||Day 365||4.7|0.4|0.9112
72370225|NCT03001817|144250984|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<0.0001
72469645|NCT03635086|144463045|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|2.4||||0.257|TWO_SIDED|95.0|0.7|7.8|||ANOVA|||Day 365||7.8|0.7|0.2570
72469646|NCT03635086|144463045|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|1.1||||0.9999|TWO_SIDED|95.0|0.3|3.8|||ANOVA|||Day 365||3.8|0.3|0.9999
72469951|NCT00559377|144463851|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.27||||0.42|TWO_SIDED||||||Regression, Cox|||This outcome is for comparing FMISO Hypoxic Volume to overall survival||||.42
72370226|NCT03001817|144250985|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann Method|||||||<0.0001
72370227|NCT03001817|144250986|SUPERIORITY|||||||0.5443|||||||Hodges-Lehmann method|||||||0.5443
72370228|NCT03001817|144250987|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann Method|||||||<0.0001
72370229|NCT03001817|144250988|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<0.0001
72449487|NCT04800211|144416722|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 2 is equal to zero on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 2 is NOT equal to zero on Visit 5 (Week 6). (mITT Population)|Mean Difference (Net)|-0.508||||0.2291|TWO_SIDED|95.0|-1.337|0.321|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 2 is equal to zero on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 2 is NOT equal to zero on Visit 5 (Week 6). (mITT Population)||0.321|-1.337|0.2291
72449488|NCT04800211|144416722|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 2 is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 2 is NOT equal to zero on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|0.525||||0.2179|TWO_SIDED|95.0|-0.311|1.361|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 2 is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 2 is NOT equal to zero on Visit 7 (Week 12). (mITT Population)||1.361|-0.311|0.2179
72449489|NCT04800211|144416722|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 + Test 2 is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 + Test 2 is NOT equal to zero on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|0.401||||0.2002|TWO_SIDED|95.0|-0.213|1.016|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 + Test 2 is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 + Test 2 is NOT equal to zero on Visit 7 (Week 12). (mITT Population)||1.016|-0.213|0.2002
72449490|NCT04800211|144416722|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Control is equal to zero on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Control is NOT equal to zero on Visit 5 (Week 6). (mITT Population)|Mean Difference (Net)|-0.29||||0.476|TWO_SIDED|95.0|-1.089|0.509|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Control is equal to zero on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Control is NOT equal to zero on Visit 5 (Week 6). (mITT Population)||0.509|-1.089|0.4760
72469647|NCT03635086|144463045|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|1.8||||0.6953|TWO_SIDED|95.0|0.5|6.2|||ANOVA|||Day 365||6.2|0.5|0.6953
72469648|NCT03635086|144463045|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|1.7||||0.7523|TWO_SIDED|95.0|0.5|5.4|||ANOVA|||Day 365||5.4|0.5|0.7523
72469649|NCT03635086|144463054|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups|Geometric Mean Ratio Estimate|0.5||||0.5263|TWO_SIDED|95.0|0.1|1.7|||ANOVA|||Day 0||1.7|0.1|0.5263
72469650|NCT03635086|144463054|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment.|Geometric Mean Ratio Estimate|1.0||||1|TWO_SIDED|95.0|0.3|3.5|||ANOVA|||Day 0||3.5|0.3|1.0000
72469651|NCT03635086|144463054|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment.|Geometric Mean Ratio Estimate|1.0||||1|TWO_SIDED|95.0|0.3|3.4|||ANOVA|||Day 0||3.4|0.3|1.0000
72469652|NCT03635086|144463054|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|1.0||||1|TWO_SIDED|95.0|0.3|3.4|||ANOVA|||Day 0||3.4|0.3|1.0000
72469653|NCT03635086|144463054|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment.|Geometric Mean Ratio Estimate|2.0||||0.55|TWO_SIDED|95.0|0.6|7.0|||ANOVA|||Day 0||7.0|0.6|0.5500
72561856|NCT01067521|144654421|SUPERIORITY||Risk Ratio (RR)|0.556|STANDARD_ERROR_OF_MEAN|0.093||0.0005|TWO_SIDED|95.0|0.4|0.773||not adjusted for multiplicity|Negative Binomial Regression||Early Start vs Delayed Start|Month 6||0.773|0.4|0.0005
72561857|NCT01067521|144654421|SUPERIORITY||Risk Ratio (RR)|0.514|STANDARD_ERROR_OF_MEAN|0.073|<|0.0001|TWO_SIDED|95.0|0.388|0.679||not adjusted for multiplicity|Negative binomial regression||Early Start vs Delayed Start|Month 12||0.679|0.388|<0.0001
72561858|NCT01067521|144654421|SUPERIORITY||Risk Ratio (RR)|0.663|STANDARD_ERROR_OF_MEAN|0.086||0.0015|TWO_SIDED|95.0|0.514|0.854||not adjusted for multiplicity|Negative binomial regression||Early Start vs Delayed Start|Month 36||0.854|0.514|0.0015
72469654|NCT03635086|144463054|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment.|Geometric Mean Ratio Estimate|2.0||||0.5263|TWO_SIDED|95.0|0.6|6.7|||ANOVA|||Day 0||6.7|0.6|0.5263
72469655|NCT03635086|144463054|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|2.0||||0.5263|TWO_SIDED|95.0|0.6|6.7|||ANOVA|||Day 0||6.7|0.6|0.5263
72561859|NCT01067521|144654422|SUPERIORITY||Mean Difference (Final Values)|-0.084|STANDARD_ERROR_OF_MEAN|0.041||0.0425|TWO_SIDED|95.0|-0.166|-0.003||not adjusted for multiplicity|Mixed model for repeated measures (MMRM)||Early Start vs Delayed Start|Month 6||-0.003|-0.166|0.0425
72469656|NCT03635086|144463054|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|1.0||||1|TWO_SIDED|95.0|0.3|3.5|||ANOVA|||Day 0||3.5|0.3|1.0000
72561860|NCT01067521|144654422|SUPERIORITY||Mean Difference (Final Values)|-0.086|STANDARD_ERROR_OF_MEAN|0.05||0.0844|TWO_SIDED|95.0|-0.184|0.012||not adjusted for multiplicity|Mixed model for repeated measures (MMRM)||Early Start vs Delayed Start|Month 12||0.012|-0.184|0.0844
72449491|NCT04800211|144416722|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Control is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Control is NOT equal to zero on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|-0.699||||0.0914|TWO_SIDED|95.0|-1.512|0.113|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Control is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Control is NOT equal to zero on Visit 7 (Week 12). (mITT Population)||0.113|-1.512|0.0914
72449492|NCT04800211|144416722|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 is equal to Control on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 is NOT equal to Control on Visit 5 (Week 6). (mITT Population)|Mean Difference (Net)|0.328||||0.9705|TWO_SIDED|95.0|-1.122|1.777|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 is equal to Control on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 is NOT equal to Control on Visit 5 (Week 6). (mITT Population)||1.777|-1.122|0.9705
72449493|NCT04800211|144416722|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|0.977||||0.328|TWO_SIDED|95.0|-0.512|2.465|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)||2.465|-0.512|0.3280
72449494|NCT04800211|144416722|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 2 is equal to Control on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 2 is NOT equal to Control on Visit 5 (Week 6). (mITT Population)|Mean Difference (Net)|-0.218||||0.9951|TWO_SIDED|95.0|-1.667|1.23|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 2 is equal to Control on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 2 is NOT equal to Control on Visit 5 (Week 6). (mITT Population)||1.230|-1.667|0.9951
72449495|NCT04800211|144416722|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|1.225||||0.1367|TWO_SIDED|95.0|-0.244|2.693|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)||2.693|-0.244|0.1367
72469657|NCT03635086|144463054|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|1.0||||1|TWO_SIDED|95.0|0.3|3.5|||ANOVA|||Day 0||3.5|0.3|1.0000
72469658|NCT03635086|144463054|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|1.0||||1|TWO_SIDED|95.0|0.3|3.4|||ANOVA|||Day 0||3.4|0.3|1.0000
72469659|NCT03635086|144463054|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|0.5||||0.7708|TWO_SIDED|95.0|0.1|2.4|||ANOVA|||Day 28||2.4|0.1|0.7708
72561861|NCT01067521|144654422|SUPERIORITY||Mean Difference (Final Values)|0.017|STANDARD_ERROR_OF_MEAN|0.106||0.8701|TWO_SIDED|95.0|-0.91|0.225||not adjusted for multiplicity|Mixed model for repeated measures (MMRM)||Early Start vs Delayed Start|Month 36||0.225|-0.91|0.8701
72622416|NCT02899754|144774785|SUPERIORITY||||||<|0.01|||||||t-test, 2 sided|||||||<0.01
72622417|NCT02899754|144774786|SUPERIORITY|||||||0.02|||||||t-test, 2 sided|||||||0.02
72622418|NCT02899754|144774787|SUPERIORITY|||||||0.01|||||||t-test, 2 sided|||||||0.01
72622419|NCT02899754|144774788|SUPERIORITY|||||||0.22|||||||t-test, 2 sided|||||||0.22
72370230|NCT03001817|144250989|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<0.0001
72370231|NCT03001817|144250990|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<0.0001
72370232|NCT03001817|144250991|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<0.0001
72370233|NCT03001817|144250992|SUPERIORITY|||||||0.4939|||||||Hodges-Lehmann method|||||||0.4939
72370234|NCT03001817|144250993|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<0.0001
72449496|NCT04800211|144416722|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 + Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 + Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|1.101||||0.0294|TWO_SIDED|95.0|0.111|2.091|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 + Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 + Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)||2.091|0.111|0.0294
72449497|NCT04800211|144416722|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 is equal to Test 2 on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 is NOT equal to Test 2 on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|-0.248||||0.6792|TWO_SIDED|95.0|-1.424|0.928|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 is equal to Test 2 on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 is NOT equal to Test 2 on Visit 7 (Week 12). (mITT Population)||0.928|-1.424|0.6792
72449498|NCT04800211|144416723|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|0.638||||0.4012|TWO_SIDED|95.0|-0.86|2.137|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||2.137|-0.860|0.4012
72449499|NCT04800211|144416723|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|2.163||||0.0201|TWO_SIDED|95.0|0.343|3.983|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||3.983|0.343|0.0201
72449500|NCT04800211|144416723|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|1.21||||0.1709|TWO_SIDED|95.0|-0.528|2.948|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||2.948|-0.528|0.1709
72469660|NCT03635086|144463054|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|1.2||||0.9966|TWO_SIDED|95.0|0.3|5.4|||ANOVA|||Day 28||5.4|0.3|0.9966
72469661|NCT03635086|144463054|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|0.7||||0.9503|TWO_SIDED|95.0|0.2|3.0|||ANOVA|||Day 28||3.0|0.2|0.9503
72469662|NCT03635086|144463054|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|0.7||||0.9791|TWO_SIDED|95.0|0.2|3.2|||ANOVA|||Day 28||3.2|0.2|0.9791
72469663|NCT03635086|144463054|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|2.2||||0.5739|TWO_SIDED|95.0|0.5|9.8|||ANOVA|||Day 28||9.8|0.5|0.5739
72498821|NCT01817790|144527882|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-0.18|||<|0.0001||95.0|-0.26|-0.09||p-value was nor adjusted for multiple comparisons.|ANCOVA|Linear Fixed-effect Model; Treatment and site as fixed factors and baseline score as covariate.||Null hypothesis was that no difference exists in the mean change from baseline in PM reflective symptom scores for Eye Tearing/watering between the Fluticasone nasal spray and the placebo nasal spray.||-0.09|-0.26|<0.0001
72622420|NCT02899754|144774789|SUPERIORITY|||||||0.18|||||||t-test, 2 sided|||||||0.18
72622421|NCT02899754|144774790|SUPERIORITY|||||||0.01|||||||Chi-squared|||chi-square test||||0.01
72449501|NCT04800211|144416723|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine Nicotine Equivalents (mg/g creatinine) in Test 2 is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 2 is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|1.593||||0.0307|TWO_SIDED|95.0|0.15|3.035|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine Nicotine Equivalents (mg/g creatinine) in Test 2 is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 2 is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||3.035|0.150|0.0307
72449502|NCT04800211|144416723|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine Nicotine Equivalents (mg/g creatinine) in Test 2 is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 2 is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|1.588||||0.0691|TWO_SIDED|95.0|-0.126|3.302|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine Nicotine Equivalents (mg/g creatinine) in Test 2 is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 2 is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||3.302|-0.126|0.0691
72449503|NCT04800211|144416723|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine Nicotine Equivalents (mg/g creatinine) in Test2 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test2 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|2.487||||0.0034|TWO_SIDED|95.0|0.838|4.137|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine Nicotine Equivalents (mg/g creatinine) in Test2 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test2 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||4.137|0.838|0.0034
72449504|NCT04800211|144416723|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 + Test 2 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 + Test 2 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|1.849||||0.0034|TWO_SIDED|95.0|0.622|3.075|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 + Test 2 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 + Test 2 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||3.075|0.622|0.0034
72469664|NCT03635086|144463054|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|1.3||||0.9918|TWO_SIDED|95.0|0.3|5.4|||ANOVA|||Day 28||5.4|0.3|0.9918
72469665|NCT03635086|144463054|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|1.4||||0.9748|TWO_SIDED|95.0|0.3|5.9|||ANOVA|||Day 28||5.9|0.3|0.9748
72469952|NCT00559377|144463851|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.05||||0.87|TWO_SIDED||||||Regression, Cox|||This outcome is for comparing FMISO T:Bmax to overall survival||||.87
72619560|NCT03537729|144769955|SUPERIORITY|Sample size was determined by power analysis for the adjusted wayfinding speed.|Mean Difference (Final Values)|-1.71|STANDARD_ERROR_OF_MEAN|1.69||0.31|TWO_SIDED|95.0|-5.03|1.6||P-value was not adjusted for multiple comparisons. A priori threshold for statistical significance was .05.|Mixed Models Analysis|Covariates included baseline value of the outcome, age, sex, and cognition score at baseline.|Cues minus control.|The null hypothesis was that means of two arms are equal, the alternative was that means were not equal.||1.60|-5.03|.31
72619561|NCT03537729|144769955|SUPERIORITY|Sample size was determined by power analysis for the adjusted wayfinding speed.|Mean Difference (Final Values)|-0.78|STANDARD_ERROR_OF_MEAN|1.75||0.66|TWO_SIDED|95.0|-4.23|2.66||P-value was not adjusted for multiple comparisons. A priori threshold for statistical significance was .05.|Mixed Models Analysis|Covariates included baseline value of the outcome, age, sex, and cognition score at baseline.|Spaced retrieval minus control.|The null hypothesis was that means of two arms are equal, the alternative was that means were not equal.||2.66|-4.23|.66
72622422|NCT02899754|144774791|SUPERIORITY|||||||0.64|||||||t-test, 2 sided|||||||0.64
72370235|NCT03001817|144250994|SUPERIORITY|||||||0.8371|||||||Hodges-Lehmann method|||||||0.8371
72370236|NCT03001817|144250995|SUPERIORITY|||||||0.3415|||||||Hodges-Lehmann method|||||||0.3415
72370237|NCT03001817|144250996|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<0.0001
72449505|NCT04800211|144416723|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine Nicotine Equivalents (mg/g creatinine) in Control is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Control is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-0.178||||0.8123|TWO_SIDED|95.0|-1.654|1.299|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine Nicotine Equivalents (mg/g creatinine) in Control is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Control is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||1.299|-1.654|0.8123
72619562|NCT03537729|144769955|SUPERIORITY|Sample size was determined by power analysis for the adjusted wayfinding speed.|Mean Difference (Final Values)|0.93|STANDARD_ERROR_OF_MEAN|1.65||0.57|TWO_SIDED|95.0|-2.3|4.17||P-value was not adjusted for multiple comparisons. A priori threshold for statistical significance was .05.|Mixed Models Analysis|Covariates included baseline value of the outcome, age, sex, and cognition score at baseline.|Spaced retrieval minus cues only.|The null hypothesis was that means of two arms are equal, the alternative was that means were not equal.||4.17|-2.30|.57
72449506|NCT04800211|144416723|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine Nicotine Equivalents (mg/g creatinine) in Control is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Control is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-0.48||||0.5879|TWO_SIDED|95.0|-2.226|1.267|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine Nicotine Equivalents (mg/g creatinine) in Control is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Control is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||1.267|-2.226|0.5879
72449507|NCT04800211|144416723|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine Nicotine Equivalents (mg/g creatinine) in Control is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Control is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-0.596||||0.491|TWO_SIDED|95.0|-2.304|1.111|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine Nicotine Equivalents (mg/g creatinine) in Control is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Control is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||1.111|-2.304|0.4910
72449508|NCT04800211|144416723|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 is equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 is NOT equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|0.816||||0.9673|TWO_SIDED|95.0|-1.967|3.599|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 is equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 is NOT equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||3.599|-1.967|0.9673
72469666|NCT03635086|144463054|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|0.6||||0.827|TWO_SIDED|95.0|0.1|2.6|||ANOVA|||Day 28||2.6|0.1|0.8270
72469667|NCT03635086|144463054|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|0.6||||0.893|TWO_SIDED|95.0|0.1|2.8|||ANOVA|||Day 28||2.8|0.1|0.8930
72469668|NCT03635086|144463054|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|1.1||||0.9999|TWO_SIDED|95.0|0.3|4.7|||ANOVA|||Day 28||4.7|0.3|0.9999
72619563|NCT02933151|144769958|SUPERIORITY||Cox Proportional Hazard|1.03|||||TWO_SIDED|95.0|0.92|1.14|||||Reference group is usual care|||1.14|0.92|
72469669|NCT03635086|144463054|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|0.6||||0.9105|TWO_SIDED|95.0|0.1|3.2|||ANOVA|||Day 56||3.2|0.1|0.9105
72469670|NCT03635086|144463054|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|1.0||||1|TWO_SIDED|95.0|0.2|5.5|||ANOVA|||Day 56||5.5|0.2|1.0000
72469671|NCT03635086|144463054|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|0.3||||0.3047|TWO_SIDED|95.0|0.1|1.7|||ANOVA|||Day 56||1.7|0.1|0.3047
72469672|NCT03635086|144463054|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment.|Geometric Mean Ratio Estimate|5.5||||0.0423|TWO_SIDED|95.0|1.0|29.2|||ANOVA|||Day 56||29.2|1.0|0.0423
72619564|NCT03400787|144769973|SUPERIORITY|||||||0.0001||||||p\<0.025 indicates statistical significance.|t-test, 1 sided|||Null hypothesis is that the responder rate for the Latera implant treatment was not superior to the sham treatment. A maximum sample size of 124 evaluable subjects is required for 90% power and preserving a 2.5% (one-sided) type I error rate.||||0.0001
72619565|NCT01644331|144770003|SUPERIORITY_OR_OTHER|||||||0.315|||||||Chi-squared|||||||0.315
72449509|NCT04800211|144416723|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 is equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 is NOT equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|2.643||||0.1787|TWO_SIDED|95.0|-0.683|5.968|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 is equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 is NOT equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||5.968|-0.683|0.1787
72449510|NCT04800211|144416723|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|1.806||||0.5243|TWO_SIDED|95.0|-1.406|5.018|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||5.018|-1.406|0.5243
72449511|NCT04800211|144416723|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine Nicotine Equivalents (mg/g creatinine) in Test 2 is equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 2 is NOT equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|1.77||||0.3956|TWO_SIDED|95.0|-0.966|4.507|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine Nicotine Equivalents (mg/g creatinine) in Test 2 is equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 2 is NOT equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||4.507|-0.966|0.3956
72469673|NCT03635086|144463054|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|1.6||||0.9213|TWO_SIDED|95.0|0.3|9.1|||ANOVA|||Day 56||9.1|0.3|0.9213
72469674|NCT03635086|144463054|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|0.5||||0.8092|TWO_SIDED|95.0|0.1|2.8|||ANOVA|||Day 56||2.8|0.1|0.8092
72469675|NCT03635086|144463054|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|9.1||||0.004|TWO_SIDED|95.0|1.7|48.5|||ANOVA|||Day 56||48.5|1.7|0.0040
72469676|NCT03635086|144463054|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|0.3||||0.3347|TWO_SIDED|95.0|0.1|1.8|||ANOVA|||Day 56||1.8|0.1|0.3347
72498822|NCT01817790|144527883|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-0.1||||0.0304||95.0|-0.18|-0.01||p-value was not adjusted for multiple comparisons.|ANCOVA|Linear Fixed-effect Model; Treatment and site as fixed factors and baseline score as covariate.||Null hypothesis was that no difference exists in the mean change from baseline in AM reflective symptom scores for Eye Redness between the Fluticasone nasal spray and the placebo nasal spray.||-0.01|-0.18|0.0304
72498823|NCT01817790|144527884|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-0.1||||0.0361||95.0|-0.19|-0.01||p-value was not adjusted for multiple comparisons.|ANCOVA|Linear Fixed-effect Model; Treatment and site as fixed factors and baseline score as covariate.||Null hypothesis was that no difference exists in the mean change from baseline in PM reflective symptom scores for Eye Redness between the Fluticasone nasal spray and the placebo nasal spray.||-0.01|-0.19|0.0361
72498824|NCT01817790|144527885|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-0.28||||0.0129|TWO_SIDED|95.0|-0.5|-0.06||p-value was not adjusted for multiple comparisons.|ANCOVA|Linear Fixed-effect Model; treatment and site as fixed factors and baseline score as covariate.||Null hypothesis was that no difference exists in the mean change from baseline in AM iTOSS between the Fluticasone nasal spray and the placebo nasal spray.||-0.06|-0.50|0.0129
72498825|NCT01817790|144527886|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-0.14||||0.0002|TWO_SIDED|95.0|-0.22|-0.07||p-value was not adjusted for multiple comparisons.|ANCOVA|Linear Fixed-effect Model; treatment and site as fixed factors and baseline score as covariate.||Null hypothesis was that no difference exists in the mean change from baseline in rNCSS between the Fluticasone nasal spray and the placebo nasal spray.||-0.07|-0.22|0.0002
72619566|NCT01644331|144770004|SUPERIORITY_OR_OTHER||Slope|0.19||||0.021|TWO_SIDED|95.0|0.03|0.34|||Mixed Models Analysis|||This is a repeated measures analysis so all rows (visits) are taken into account.||0.34|0.03|0.021
72619567|NCT01644331|144770005|SUPERIORITY_OR_OTHER||Slope|0.99||||0.43|TWO_SIDED|95.0|-1.47|3.44|||Mixed Models Analysis|||This a repeated measure analysis so all rows (visits) are taken into account.||3.44|-1.47|0.430
72449512|NCT04800211|144416723|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine Nicotine Equivalents (mg/g creatinine) in Test 2 is equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 2 is NOT equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|2.068||||0.381|TWO_SIDED|95.0|-1.16|5.295|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine Nicotine Equivalents (mg/g creatinine) in Test 2 is equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 2 is NOT equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||5.295|-1.160|0.3810
72469677|NCT03635086|144463054|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|5.6||||0.0488|TWO_SIDED|95.0|1.0|30.7|||ANOVA|||Day 56||30.7|1.0|0.0488
72469678|NCT03635086|144463054|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|17.4||||0.0001|TWO_SIDED|95.0|3.3|92.2|||ANOVA|||Day 56||92.2|3.3|0.0001
72561862|NCT00766493|144654424|SUPERIORITY_OR_OTHER||Proportion|0.043|STANDARD_ERROR_OF_MEAN|0.013||0.0001|TWO_SIDED|95.0|0.021|0.077||Reject H0 if z\<-1.96, or 1-sided p\<0.025.|One Sample Binomial|Significance test was based on a one-sample normal approximation to the binomial test.|The 2-sided 95% CI is reported for descriptive purposes; the statistical hypothesis test is 1-sided.|"This study is designed to test the primary null hypothesis that the composite MAE outcome of all death, stroke, and/or MI when using the GORE Embolic Filter is equal to or higher than a Performance Goal (PG) of 6.4% established from published carotid stenting studies utilizing distal embolic protection, versus the alternative hypothesis that the composite MAE outcome is less than the performance goal.~The sample size was calculated based on 80% power and a 1-sided Type I error rate of 0.025."||0.077|0.021|0.0001
72370238|NCT03001817|144250997|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<0.0001
72469679|NCT03635086|144463054|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|0.6||||0.8831|TWO_SIDED|95.0|0.1|3.0|||ANOVA|||Day 182||3.0|0.1|0.8831
72469680|NCT03635086|144463054|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|1.0||||1|TWO_SIDED|95.0|0.2|5.2|||ANOVA|||Day 182||5.2|0.2|1.0000
72498826|NCT01817790|144527887|SUPERIORITY_OR_OTHER|||||||0.0118||95.0||||p-value was not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Using this test controlling for investigative site. The response variable lied on ordinal scale of measurement.||Null hypothesis was that no difference exists in the end of treatment assessment of response between the Fluticasone nasal spray and the placebo nasal spray.||||0.0118
72498827|NCT01817790|144527888|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-0.01||||0.8586|TWO_SIDED|95.0|-0.12|0.1|||ANCOVA|||Null hypothesis was that no difference exists in the mean change from baseline in objective assessment of conjunctival redness between the Fluticasone nasal spray and the placebo nasal spray.||0.10|-0.12|0.8586
72498828|NCT01817790|144527889|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-0.47|||<|0.0001|TWO_SIDED|95.0|-0.65|-0.29||p-value was not adjusted for multiple comparisons.|ANCOVA|Linear Fixed-effect Model; Treatment and site as fixed factors and baseline score as covariate.||Null hypothesis was that no difference exists in the mean change from baseline in MiniRQLQ scores between the Fluticasone nasal spray and the placebo nasal spray.||-0.29|-0.65|<0.0001
72498829|NCT01817790|144527890|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-0.49|||<|0.0001|TWO_SIDED|95.0|-0.68|-0.3||p-value was not adjusted for multiple comparisons.|ANCOVA|Linear Fixed-effect Model; Treatment and site as fixed factors and baseline score as covariate.||Null hypothesis was that no difference exists in the mean change from baseline in 'Activities' domain of MiniRQLQ scores between the Flutical sone nasal spray and placebo nasal spray||-0.30|-0.68|<0.0001
72370239|NCT03001817|144250998|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<0.0001
72370240|NCT03001817|144250999|SUPERIORITY|||||||0.7442|||||||Hodges-Lehmann method|||||||0.7442
72498830|NCT01817790|144527891|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-0.44|||<|0.0001|TWO_SIDED|95.0|-0.64|-0.24||p-value was not adjusted for multiple comparisons.|ANCOVA|Linear Fixed-effect Model; Treatment and site as fixed factors and baseline score as covariate.||Null hypothesis was that no difference exists in the mean change from baseline in 'Practical Problems' domain of MiniRQLQ scores between the Flutical sone nasal spray and placebo nasal spray.||-0.24|-0.64|<0.0001
72498831|NCT01817790|144527892|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-0.53|||<|0.0001|TWO_SIDED|95.0|-0.73|-0.33||p-value was not adjusted for multiple comparisons.|ANCOVA|Linear Fixed-effect Model; Treatment and site as fixed factors and baseline score as covariate.||Null hypothesis was that no difference exists in the mean change from baseline in 'Nose Symptoms' domain of MiniRQLQ scores between the Flutical sone nasal spray and placebo nasal spray.||-0.33|-0.73|<0.0001
72561863|NCT00452543|144654430|NON_INFERIORITY_OR_EQUIVALENCE|This was a test of non-inferiority between the effects of acamprosate vs. placebo. Power analysis was originally based on ITT analysis with 40 subjects, and assumed 30% difference in alcohol consumption (50% vs. 20% reduction in the acamprosate and placebo groups, respectively). With alpha of 0.05, we estimated 74% power to detect a difference between the two groups. Results would be used to estimate effect size to set the stage for an adequately powered larger study in the future.|||||<|0.05||95.0||||Threshold for significance was set a priori at p\<0.05.|Wilcoxon (Mann-Whitney)|||Statistical analyses evaluated the null hypothesis that there would be no difference in the effect of acamprosate vs. placebo on total drinking days.Power analysis was originally based on ITT analysis with 40 subjects, and assumed 30% difference in alcohol consumption (50% vs. 20% reduction in the acamprosate and placebo groups, respectively). With alpha of 0.05, we estimated 74% power to detect a difference between the two groups.||||<0.05
72619568|NCT01644331|144770006|SUPERIORITY_OR_OTHER||Slope|-493.21||||0.157|TWO_SIDED|95.0|-1176.96|190.55|||Mixed Models Analysis|||This is a repeated measures analysis so all rows (visits) are taken into account.||190.55|-1176.96|0.157
72370241|NCT03001817|144251000|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<.0001
72449513|NCT04800211|144416723|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine Nicotine Equivalents (mg/g creatinine) in Test 2 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 2 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|3.084||||0.0557|TWO_SIDED|95.0|-0.049|6.216|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine Nicotine Equivalents (mg/g creatinine) in Test 2 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 2 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||6.216|-0.049|0.0557
72449514|NCT04800211|144416723|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 + Test 2 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 + Test 2 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|2.445||||0.0195|TWO_SIDED|95.0|0.4|4.49|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 + Test 2 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 + Test 2 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||4.490|0.400|0.0195
72449515|NCT04800211|144416723|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine Nicotine Equivalents (mg/g creatinine) in Test 2 is equal to Test 1 on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 2 is NOT equal to Test 1 on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-1.277||||0.2817|TWO_SIDED|95.0|-3.615|1.06|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine Nicotine Equivalents (mg/g creatinine) in Test 2 is equal to Test 1 on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 2 is NOT equal to Test 1 on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||1.060|-3.615|0.2817
72449516|NCT03806790|144416724|SUPERIORITY||Odds Ratio (OR)|5.8||||0.12|TWO_SIDED|95.0|0.68|49.16|||Fisher Exact|||Statistical analysis on the Full Analysis Set (FAS)||49.16|0.68|0.120
72449517|NCT03806790|144416725|SUPERIORITY||Odds Ratio (OR)|2.5||||0.004|TWO_SIDED|95.0|1.36|4.6|||Fisher Exact|||End of Week 1 (FAS)||4.60|1.36|0.004
72449518|NCT03806790|144416725|SUPERIORITY||Odds Ratio (OR)|4.85||||0.003|TWO_SIDED|95.0|1.57|14.97|||Fisher Exact|||End of Week 2 (FAS)||14.97|1.57|0.003
72449519|NCT03806790|144416726|SUPERIORITY||Estimated difference|-1.11|||<|0.001|TWO_SIDED|95.0|-1.64|-0.59|||ANOVA|||FAS||-0.59|-1.64|<0.001
72561864|NCT00452543|144654431|NON_INFERIORITY_OR_EQUIVALENCE|This was a test of non-inferiority between the effects of acamprosate vs. placebo.|||||<|0.05||95.0||||This p \<0.05 was set a priori.|Wilcoxon (Mann-Whitney)|||Statistical analyses evaluated the null hypothesis that there would be no difference in the effect of acamprosate vs. placebo on total drinks consumed per week.Power analysis was originally based on ITT analysis with 40 subjects, and assumed 30% difference in alcohol consumption (50% vs. 20% reduction in the acamprosate and placebo groups, respectively). With alpha of 0.05, we estimated 74% power to detect a difference between the two groups.||||<0.05
72449520|NCT02432261|144416767|SUPERIORITY|We did not statistically power this study.|difference of proportion of subjects|57.6||||0.003|TWO_SIDED||||||Fisher Exact||The difference of proportion = NES/Testosterone - Testosterone|||||0.003
72449521|NCT04228042|144416868|SUPERIORITY|||||||0.009|||||||Wilcoxon (Mann-Whitney)|||||||0.009
72449522|NCT04228042|144416868|SUPERIORITY|||||||0.04|||||||Wilcoxon (Mann-Whitney)|||||||0.04
72449523|NCT04228042|144416868|SUPERIORITY|||||||0.003|||||||Wilcoxon (Mann-Whitney)|||||||0.003
72449524|NCT04228042|144416868|SUPERIORITY|||||||0.03|||||||Wilcoxon (Mann-Whitney)|||||||0.03
72449525|NCT05452460|144416924|SUPERIORITY||Mean Difference (Final Values)|0.11|||>|0.05|TWO_SIDED||||||ANCOVA|ANCOVA with post-test condition difference in RT as the outcome, with Group as the factor, and pre-test condition difference in RT as the covariate.||||||> 0.05
72449526|NCT05452460|144416925|SUPERIORITY||Mean Difference (Final Values)|0.18|||>|0.05|TWO_SIDED||||||ANCOVA|ANCOVA with post-test condition difference in ACC the outcome, with Group as the factor, and pre-test condition difference in ACC as the covariate.||||||> .05
72561865|NCT00452543|144654432|NON_INFERIORITY_OR_EQUIVALENCE|"This was a test of non-inferiority between the effects of acamprosate vs. placebo. Statistical analyses evaluated the null hypothesis that there would be no difference in the effect of acamprosate vs. placebo on total drinks consumed per drinking day.~Power analysis is discussed above."|||||<|0.05||95.0||||This p\<0.05 was set a priori.|Wilcoxon (Mann-Whitney)|||"Statistical analyses evaluated the null hypothesis that there would be no difference in the effect of acamprosate vs. placebo on total drinks consumed per drinking day.~Power analysis was originally based on ITT analysis with 40 subjects, and assumed 30% difference in alcohol consumption (50% vs. 20% reduction in the acamprosate and placebo groups, respectively). With alpha of 0.05, we estimated 74% power to detect a difference between the two groups."||||<0.05
72561866|NCT01849458|144654452|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|32.6|STANDARD_DEVIATION|26.0||0.0001|TWO_SIDED|95.0|25.2|40.0|||2-sided, paired t-test|||Difference from baseline (6M-Baseline)||40|25.2|0.0001
72449527|NCT05452460|144416926|SUPERIORITY||Mean Difference (Final Values)|0.32|||>|0.05|TWO_SIDED||||||ANCOVA|ANCOVA with post-test condition difference in N2 the outcome, with Group as the factor, and pre-test condition difference in N2 as the covariate.||||||> 0.05
72449528|NCT05452460|144416927|SUPERIORITY||Mean Difference (Final Values)|0.71|||>|0.05|TWO_SIDED||||||ANCOVA|ANCOVA with post-test condition difference in P3 the outcome, with Group as the factor, and pre-test condition difference in P3 as the covariate.||||||> 0.05
72449529|NCT05452460|144416928|SUPERIORITY||Mean Difference (Final Values)|13.35|||<|0.01|TWO_SIDED||||||ANCOVA|ANCOVA with post-test condition difference in TTE the outcome, with Group as the factor, and pre-test condition difference in TTE as the covariate.|\[F(1, 52) = 13.35, p = .001, ηp2 = .211\]|||||< 0.01
72449530|NCT05452460|144416929|SUPERIORITY||Mean Difference (Final Values)|0.02|||>|0.05|TWO_SIDED||||||ANCOVA|Factor: Group Outcome: Post-test condition difference in VO2max Covariate: Pre-test condition difference in VO2max||||||> 0.05
72449531|NCT05452460|144416930|SUPERIORITY||Mean Difference (Final Values)|38.76|||<|0.01|TWO_SIDED||||||ANOVA|Four-way mixed-design ANOVA: 2 (GROUP) × 2 (CONDITION) × 3 (ASSESSMENT TIME) × 2 (Experiment Phase)||||||< 0.01
72449532|NCT05452460|144416931|SUPERIORITY||Mean Difference (Final Values)|9.21|||<|0.01|TWO_SIDED|||||The main effect of the Stroop block on accuracy showed a decrease from the first block to the fifth block.|ANOVA|Four-way mixed-design ANOVA: 2 (GROUP) × 2 (CONDITION) × 5 (BLOCK) × 2 (Phase)||||||< 0.01
72449533|NCT05452460|144416932|SUPERIORITY||Mean Difference (Final Values)|7.07|||<|0.05|TWO_SIDED||||||ANCOVA|Factor: Group Outcome: Post-test mean score Covariate: Pre-test mean score||||||< 0.05
72449534|NCT05452460|144416933|SUPERIORITY||Mean Difference (Final Values)|1.37|||>|0.05|TWO_SIDED||||||ANCOVA|Factor: Group Outcome: Post-test condition difference in changed anger Covariate: Pre-test condition difference in changed anger||||||> 0.05
72449535|NCT05452460|144416934|SUPERIORITY||Mean Difference (Final Values)|2.73|||>|0.05|TWO_SIDED||||||ANCOVA|Factor: Group Outcome: Post-test condition difference in changed confusion Covariate: Pre-test condition difference in changed confusion||||||> 0.05
72449536|NCT05452460|144416935|SUPERIORITY||Mean Difference (Final Values)|0.07|||>|0.05|TWO_SIDED||||||ANCOVA|Factor: Group Outcome: Post-test condition difference in changed depression Covariate: Pre-test condition difference in changed depression||||||> 0.05
72449537|NCT05452460|144416936|SUPERIORITY||Mean Difference (Final Values)|0.2|||>|0.05|TWO_SIDED||||||ANCOVA|Factor: Group Outcome: Post-test condition difference in changed fatigue Covariate: Pre-test condition difference in changed fatigue||||||> 0.05
72449538|NCT05452460|144416937|SUPERIORITY||Mean Difference (Final Values)|0.01|||>|0.05|TWO_SIDED||||||ANCOVA|Factor: Group Outcome: Post-test condition difference in changed confusion Covariate: Pre-test condition difference in changed confusion||||||> 0.05
72449539|NCT05452460|144416938|SUPERIORITY||Mean Difference (Final Values)|0.66|||>|0.05|TWO_SIDED||||||ANCOVA|Factor: Group Outcome: Post-test condition difference in changed confusion Covariate: Pre-test condition difference in changed confusion||||||> 0.05
72449540|NCT04447040|144416953|SUPERIORITY||Least square (LS) Mean Difference|31.48|STANDARD_ERROR_OF_MEAN|5.379|<|0.001|TWO_SIDED|95.0|20.9|42.07|||ANOVA|||||42.07|20.90|<0.001
72619569|NCT01644331|144770007|SUPERIORITY_OR_OTHER|||||||0.206|||||||Chi-squared|||This is a repeated measures analysis so all rows (visits) are taken into account.||||0.206
72449541|NCT04447040|144416953|SUPERIORITY||LS Mean Difference|41.38|STANDARD_ERROR_OF_MEAN|5.267|<|0.001|TWO_SIDED|95.0|31.02|51.75|||ANOVA|||||51.75|31.02|<0.001
72449542|NCT04447040|144416953|SUPERIORITY||LS Mean Difference|46.86|STANDARD_ERROR_OF_MEAN|5.292|<|0.001|TWO_SIDED|95.0|36.44|57.27|||ANOVA|||||57.27|36.44|<0.001
72449543|NCT04447040|144416953|SUPERIORITY||LS Mean Difference|54.04|STANDARD_ERROR_OF_MEAN|5.321|<|0.001|TWO_SIDED|95.0|43.57|64.51|||ANOVA|||||64.51|43.57|<0.001
72449544|NCT04447040|144416953|SUPERIORITY||LS Mean Difference|59.92|STANDARD_ERROR_OF_MEAN|5.468|<|0.001|TWO_SIDED|95.0|49.16|70.68|||ANOVA|||||70.68|49.16|<0.001
72449545|NCT04447040|144416954|SUPERIORITY||LS Mean Difference|35.66|STANDARD_ERROR_OF_MEAN|6.542|<|0.001|TWO_SIDED|95.0|22.79|48.54|||ANOVA|||||48.54|22.79|<0.001
72449546|NCT04447040|144416954|SUPERIORITY||LS Mean Difference|49.04|STANDARD_ERROR_OF_MEAN|6.407|<|0.001|TWO_SIDED|95.0|36.44|61.65|||ANOVA|||||61.65|36.44|<0.001
72449547|NCT04447040|144416954|SUPERIORITY||LS Mean Difference|53.64|STANDARD_ERROR_OF_MEAN|6.437|<|0.001|TWO_SIDED|95.0|40.97|66.31|||ANOVA|||||66.31|40.97|<0.001
72449548|NCT04447040|144416954|SUPERIORITY||LS Mean Difference|60.93|STANDARD_ERROR_OF_MEAN|6.472|<|0.001|TWO_SIDED|95.0|48.19|73.67|||ANOVA|||||73.67|48.19|<0.001
72449549|NCT04447040|144416954|SUPERIORITY||LS Mean Difference|67.58|STANDARD_ERROR_OF_MEAN|6.65|<|0.001|TWO_SIDED|95.0|54.49|80.67|||ANOVA|||||80.67|54.49|<0.001
72449550|NCT04447040|144416955|SUPERIORITY||LS mean Difference|12.53|STANDARD_ERROR_OF_MEAN|3.097|<|0.001|TWO_SIDED|95.0|6.44|18.63|||ANOVA|||||18.63|6.44|<0.001
72449551|NCT04447040|144416955|SUPERIORITY||LS MEAN Difference|17.73|STANDARD_ERROR_OF_MEAN|3.032|<|0.001|TWO_SIDED|95.0|11.76|23.7|||ANOVA|||||23.70|11.76|<0.001
72449552|NCT04447040|144416955|SUPERIORITY||LS Mean Difference|21.88|STANDARD_ERROR_OF_MEAN|3.047|<|0.001|TWO_SIDED|95.0|15.89|27.88|||ANOVA|||||27.88|15.89|<0.001
72449553|NCT04447040|144416955|SUPERIORITY||LS Mean Difference|25.01|STANDARD_ERROR_OF_MEAN|3.063|<|0.001|TWO_SIDED|95.0|18.98|31.03|||ANOVA|||||31.03|18.98|<0.001
72449554|NCT04447040|144416955|SUPERIORITY||LS Mean Difference|29.3|STANDARD_ERROR_OF_MEAN|3.148|<|0.001|TWO_SIDED|95.0|23.11|35.5|||ANOVA|||||35.50|23.11|<0.001
72449555|NCT04447040|144416956|SUPERIORITY||||||<|0.001|||||||Wilcoxon test|||||||<0.001
72449556|NCT04447040|144416956|SUPERIORITY||||||<|0.001|||||||Wilcoxon test|||||||<0.001
72449557|NCT04447040|144416956|SUPERIORITY||||||<|0.001|||||||Wilcoxon test|||||||<0.001
72619570|NCT01644331|144770008|SUPERIORITY_OR_OTHER||Kaplan Meier|0.98||||0.334|TWO_SIDED|95.0|0.96|0.99|||Log Rank|||||0.99|0.96|0.334
72449558|NCT04447040|144416956|SUPERIORITY||||||<|0.001|||||||Wilcoxon test|||||||<0.001
72449559|NCT04447040|144416956|SUPERIORITY||||||<|0.001|||||||Wilcoxon test|||||||<0.001
72449560|NCT04447040|144416957|SUPERIORITY|||||||0.014|||||||Wald method|||||||0.014
72449561|NCT04447040|144416957|SUPERIORITY|||||||0.002|||||||Wald method|||||||0.002
72449562|NCT04447040|144416957|SUPERIORITY||||||<|0.001|||||||Wald method|||||||<0.001
72449563|NCT04447040|144416957|SUPERIORITY||||||<|0.001|||||||Wald method|||||||<0.001
72449564|NCT04447040|144416957|SUPERIORITY||||||<|0.001|||||||Wald method|||||||<0.001
72561867|NCT01849458|144654453|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|35.7|STANDARD_DEVIATION|23.6||0.0001|TWO_SIDED|95.0|28.7|42.7|||2-sided, paired t-test|||Difference from baseline (12M-Baseline)||42.7|28.7|0.0001
72449565|NCT01208662|144416958|SUPERIORITY||Hazard Ratio (HR)|1.53|||<|0.001|TWO_SIDED|95.0|1.23|1.91|||Log Rank|Observed Stratified Log Rank Test (1-sided p-value)||||1.91|1.23|<0.001
72449566|NCT01208662|144416959|SUPERIORITY|||||||0.55|||||||Fisher Exact|||Exact (Clopper-Pearson) confidence limits of 98.2857% represents Bonferroni adjustment for 7 tests (1-0.05/7) per statistical analysis plan for key secondary outcomes.||||0.55
72449567|NCT01208662|144416960|SUPERIORITY|||||||0.99|||||||Fisher Exact|||Exact (Clopper-Pearson) confidence limits of 98.2857% represents Bonferroni adjustment for 7 tests (1-0.05/7) per statistical analysis plan for key secondary outcomes.||||0.99
72449568|NCT01208662|144416961|SUPERIORITY|||||||0.99|||||||Fisher Exact|||Exact (Clopper-Pearson) confidence limits of 98.2857% represents Bonferroni adjustment for 7 tests (1-0.05/7) per statistical analysis plan for key secondary outcomes.||||0.99
72449569|NCT01208662|144416963|SUPERIORITY||Hazard Ratio (HR)|1.66|||<|0.001|TWO_SIDED|99.29|1.21|2.27|||Log Rank|Stratified||Exact (Clopper-Pearson) confidence limits of 98.2857% represents Bonferroni adjustment for 7 tests (1-0.05/7) per statistical analysis plan for key secondary outcomes.||2.27|1.21|<0.001
72449570|NCT01208662|144416964|SUPERIORITY||Hazard Ratio (HR)|1.1|||>|0.99|TWO_SIDED|95.0|0.73|1.65|||Log Rank|||||1.65|0.73|>0.99
72449571|NCT01208662|144416966|SUPERIORITY||Hazard Ratio (HR)|1.1||||0.99|TWO_SIDED|99.29|0.73|1.65|||Log Rank|Stratified||Exact (Clopper-Pearson) confidence limits of 98.2857% represents Bonferroni adjustment for 7 tests (1-0.05/7) per statistical analysis plan for key secondary outcomes.||1.65|0.73|0.99
72449572|NCT01208662|144416973|SUPERIORITY||Odds Ratio (OR)|0.55|||||TWO_SIDED|95.0|0.3|1.01||||||||1.01|0.30|
72449573|NCT01928394|144417018|SUPERIORITY||Odds Ratio (OR)|2.12||||0.0309|TWO_SIDED|95.0|1.06|4.26|||Cochran-Mantel-Haenszel|||SCLC Arm N Expansion as compare to SCLC Arm N-I Dose Level 2- Expansion||4.26|1.06|0.0309
72449574|NCT04433208|144417019|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||||||<0.0001
72449575|NCT04731129|144417025|SUPERIORITY|||||||0.023||||||threshold for statistical significance \< 0.05|Fisher Exact|||Abnormal tissular architecture||||0.023
72449576|NCT04731129|144417025|SUPERIORITY|||||||0.01||||||Threshold for statistical significance \< 0.05|Fisher Exact|||Homogeneous cell size||||0.01
72449577|NCT04731129|144417025|SUPERIORITY|||||||0.01||||||threshold for statistical significance \< 0.05|Fisher Exact|||Homogeneous cell shape||||0.01
72449578|NCT04731129|144417025|SUPERIORITY|||||||0.013||||||threshold for statistical significance \< 0.05|Fisher Exact|||Homogeneous cell fluorescence||||0.013
72449579|NCT04731129|144417025|SUPERIORITY|||||||0.16||||||threshold for statistical significance \< 0.05|Fisher Exact|||Blood vessel dysplasia||||0.16
72449580|NCT04731129|144417025|SUPERIORITY|||||||0.17||||||threshold for statistical significance \< 0.05|Fisher Exact|||Organized conjunctive fibers||||0.17
72449581|NCT04731129|144417025|SUPERIORITY|||||||0.049||||||threshold for statistical significance \< 0.05|Fisher Exact|||Full chia seed sign||||0.049
72449582|NCT04731129|144417025|SUPERIORITY|||||||0.0041||||||threshold for statistical significance \< 0.05|Fisher Exact|||General physician conclusion||||0.0041
72449583|NCT03386578|144417038|OTHER||Incidence rate ratio|1.62|||||TWO_SIDED|95.0|0.89|2.94||||||The incidence rate ratio of cumulative maternal adverse events was calculated between PrEP-exposed group (Cohort 1 and Cohort 2/Step 2) and the PrEP-unexposed (Cohort 2/Step 1) reference group based on incidence per person-time follow-up. Maternal participants in Cohort 2/Step 2 contributed person-time to both Cohort 2/Step 1 and Step 2.||2.94|0.89|
72449584|NCT03386578|144417039|OTHER||Odds Ratio (OR)|0.88|||||TWO_SIDED|95.0|0.52|1.5||||||Odds ratio comparing the proportion of mothers with adverse pregnancy outcomes between the PrEP-exposed group (Cohort 1 and Cohort 2/Step 2) and PrEP-unexposed (Cohort 2/Step 1) reference group.||1.50|0.52|
72449585|NCT03386578|144417039|OTHER|||||||0.68|||||||Fisher Exact|||Test the differences in the proportion of mothers with adverse pregnancy outcomes between PrEP-exposed (Cohort 1 and Cohort 2/Step 2) and PrEP-unexposed (Cohort 2/Step 2) groups.||||0.68
72449586|NCT03386578|144417040|OTHER||Incidence rate ratio|1.29|||||TWO_SIDED|95.0|0.7|2.38||||||The incidence rate ratio of cumulative infant AEs between PrEP-exposed group (Cohort 1 and Cohort 2/Step 2) and PrEP-unexposed (Cohort 2/Step 1) reference group was based on incidence per person-time follow-up. Cohort 2/Step 2 infants contributed person-time to both Cohort 2/Step 1 and Step 2.||2.38|0.70|
72449587|NCT03386578|144417041|OTHER|||||||0.18|||||||t-test, 2 sided|||A two-sample t-test was used to evaluate the difference in mean infant whole-body bone mineral content (WB-BMC) at birth between PrEP-exposed group (Cohort 1 and Cohort 2/Step 2) and PrEP-unexposed group (Cohort 2/Step 1).||||0.18
72449588|NCT03386578|144417042|OTHER|||||||0.39|||||||t-test, 2 sided|||A two-sample t-test was used to evaluate the difference in mean infant lumbar-spine bone mineral content (WB-BMC) at birth between PrEP-exposed group (Cohort 1 and Cohort 2/Step 2) and PrEP-unexposed group (Cohort 2/Step 1).||||0.39
72449589|NCT03386578|144417043|OTHER|||||||0.12|||||||t-test, 2 sided|||A two-sample t-test was used to evaluate the difference in mean infant lumbar-spine bone mineral content (WB-BMC) at week 26 between PrEP-exposed group (Cohort 1 and Cohort 2/Step 2) and PrEP-unexposed group (Cohort 2/Step 1).||||0.12
72449590|NCT03386578|144417044|OTHER|||||||0.7|||||||t-test, 2 sided|||A two-sample t-test was used to evaluate the difference in mean infant creatinine levels at birth between PrEP-exposed group (Cohort 1 and Cohort 2/Step 2) and PrEP-unexposed group (Cohort 2/Step 1).||||0.70
72449591|NCT03386578|144417045|OTHER|||||||0.58|||||||t-test, 2 sided|||A two-sample t-test was used to evaluate the difference in mean infant creatinine levels at week 26 between PrEP-exposed group (Cohort 1 and Cohort 2/Step 2) and PrEP-unexposed group (Cohort 2/Step 1).||||0.58
72469953|NCT00559377|144463852|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.18||||0.58|TWO_SIDED||||||Regression, Cox|||This outcome is for comparison of FMISO Hypoxic Volume to disease-free survival||||.58
72561868|NCT01849458|144654454|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|43.8|STANDARD_DEVIATION|22.2||0.0001|TWO_SIDED|95.0|37.4|50.1|||2-sided, paired t-test|||Difference from baseline (6M-Baseline)||50.1|37.4|0.0001
72561869|NCT01849458|144654455|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|49.2|STANDARD_DEVIATION|20.2||0.0001|TWO_SIDED|95.0|43.2|55.2|||2-sided, paired t-test|||Difference from baseline (12M-Baseline)||55.2|43.2|0.0001
72619571|NCT01644331|144770009|SUPERIORITY_OR_OTHER|||||||0.148|||||||Chi-squared|||||||0.148
72449592|NCT03386578|144417046|OTHER|||||||0.08|||||||t-test, 2 sided|||A two-sample t-test was used to evaluate the difference in mean infant creatinine clearance rate at birth between PrEP-exposed group (Cohort 1 and Cohort 2/Step 2) and PrEP-unexposed group (Cohort 2/Step 1).||||0.08
72449593|NCT03386578|144417047|OTHER|||||||0.52|||||||t-test, 2 sided|||A two-sample t-test was used to evaluate the difference in mean infant creatinine clearance rate at week 26 between PrEP-exposed group (Cohort 1 and Cohort 2/Step 2) and PrEP-unexposed group (Cohort 2/Step 1)||||0.52
72449594|NCT03386578|144417048|OTHER|||||||0.3|||||||t-test, 2 sided|||A two-sample t-test was used to evaluate the difference in mean infant length-for-age z-score at birth between PrEP-exposed group (Cohort 1 and Cohort 2/Step 2) and PrEP-unexposed group (Cohort 2/Step 1).||||0.30
72449595|NCT03386578|144417049|OTHER|||||||0.06|||||||t-test, 2 sided|||A two-sample t-test was used to evaluate the difference in mean infant length-for-age z-score at week 26 between PrEP-exposed group (Cohort 1 and Cohort 2/Step 2) and PrEP-unexposed group (Cohort 2/Step 1).||||0.06
72449596|NCT03386578|144417050|OTHER||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||||||<0.01
72449597|NCT05093842|144417064|SUPERIORITY||||||<|0.05|||||||Mixed Models Analysis|||||||<0.05
72449598|NCT05093842|144417065|SUPERIORITY||||||<|0.05|||||||Mixed Models Analysis|||||||<0.05
72449599|NCT05093842|144417066|SUPERIORITY||||||<|0.05|||||||Mixed Models Analysis|||||||<0.05
72449600|NCT05093842|144417067|OTHER|Descriptive rates were calculated.|||||||||||||||||Descriptive statistics only|||
72449601|NCT05093842|144417068|OTHER|Descriptive statistics only|||||||||||||||||Descriptive statistics only|||
72449602|NCT05093842|144417069|OTHER|Descriptive statistics only|||||||||||||||||Descriptive statistics only|||
72449603|NCT05093842|144417070|OTHER|Descriptive statistics only|||||||||||||||||Descriptive statistics only|||
72449604|NCT02724969|144417071|SUPERIORITY|||||||0.272|||||||Mixed Models Analysis|||||||.272
72449605|NCT02724969|144417072|SUPERIORITY|||||||0.082|||||||Mixed Models Analysis|||||||.082
72449606|NCT02724969|144417073|SUPERIORITY|||||||0.355|||||||Mixed Models Analysis|||||||.355
72619572|NCT01644331|144770010|SUPERIORITY_OR_OTHER|||||||0.334|||||||Chi-squared|||||||0.334
72370242|NCT03001817|144251001|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<.0001
72449607|NCT02724969|144417074|SUPERIORITY|||||||0.78|||||||Mixed Models Analysis|||||||.780
72449608|NCT02724969|144417075|SUPERIORITY|||||||0.588|||||||Mixed Models Analysis|||||||.588
72449609|NCT04587453|144417176|OTHER|No formal testing was performed. Confidence intervals (CIs) are presented with two sided 95% degree of confidence.|Risk Difference (RD)|5.7|||||TWO_SIDED|95.0|-11.2|22.5|||||Mantel-Haenzel risk difference, stratified by baseline IGA.|Responders were considered those meeting an IGA score of 0 or 1 (clear or almost clear). Subjects with missing data or subjects who had received rescue medication prior to Week 16 were considered non-responders in the primary analysis of the primary estimand.||22.5|-11.2|
72449610|NCT04587453|144417177|OTHER|No formal testing was performed. CIs are presented with two sided 95% degree of confidence.|Risk Difference (RD)|15.1|||||TWO_SIDED|95.0|-2.9|33.0|||||Mantel-Haenzel risk difference, stratified by baseline IGA.|Subjects with 75% reduction in EASI were considered responders. Subjects with missing data or subjects who had received rescue medication prior to Week 16 were considered non-responders in the primary analysis of the primary estimand.||33.0|-2.9|
72449611|NCT04587453|144417178|OTHER|No formal testing was performed. CIs are presented with two sided 95% degree of confidence.|Mean Difference (Net)|-5.1|||||TWO_SIDED|95.0|-12.4|2.3|||||Analysis of covariance (ANCOVA). Worst observation carried forward for all subjects who prior to Week 16 had received rescue medication. Multiple imputation of missing values for subjects who had not received rescue medication.|||2.3|-12.4|
72449612|NCT04587453|144417179|OTHER|No formal testing was performed. CIs are presented with two sided 95% degree of confidence.|Mean Difference (Net)|-1.1|||||TWO_SIDED|95.0|-2.7|0.5|||||ANCOVA. Worst observation carried forward for all subjects who prior to Week 16 had received rescue medication. Multiple imputation of missing values for subjects who had not received rescue medication.|||0.5|-2.7|
72449613|NCT04587453|144417180|OTHER|No formal testing was performed. CIs are presented with two sided 95% degree of confidence.|Risk Difference (RD)|-3.8|||||TWO_SIDED|95.0|-21.7|14.2|||||Mantel-Haenszel risk difference, stratified by baseline IGA.|Subjects with at least a reduction of 4 in the worst daily pruritus NRS score were considered responders. Subjects who had received rescue medication were considered non-responders. Subjects with missing data at Week 16 were imputed as non-responders.||14.2|-21.7|
72449614|NCT04587453|144417181|OTHER|No formal testing was performed. CIs are presented with two sided 95% degree of confidence.|Risk Difference (RD)|15.1|||||TWO_SIDED|95.0|-3.0|33.2|||||Mantel-Haenszel risk difference, stratified by baseline IGA.|Subjects with a reduction of 90% in EASI were considered responders. Subjects who had received rescue medication were considered non-responders. Subjects with missing data were imputed as non-responders.||33.2|-3.0|
72449615|NCT04587453|144417182|OTHER|No formal testing was performed. CIs are presented with two sided 95% degree of confidence.|Risk Difference (RD)|5.7|||||TWO_SIDED|95.0|-9.0|20.3|||||Mantel-Haenszel risk difference, stratified by baseline IGA.|Subjects with at least 50% reduction in EASI were considered responders. Subjects who had received rescue medication were considered non-responders. Subjects with missing data were imputed as non-responders.||20.3|-9.0|
72449616|NCT04587453|144417183|OTHER|No formal testing was performed. CIs are presented with two sided 95% degree of confidence.|Mean Difference (Net)|-4.3|||||TWO_SIDED|95.0|-14.9|6.3|||||Repeated measurements Model: Change=Treatment\*Week+Baseline\*Week+Baseline IGA. Data after permanent discontinuation of IMP/initiation of rescue medication not included (4 subjects excluded). Week 2 change imputed as 0 if no post-baseline assessments.|||6.3|-14.9|
72449617|NCT04587453|144417184|OTHER|No formal testing was performed. CIs are presented with two sided 95% degree of confidence.|Mean Difference (Net)|0.1|||||TWO_SIDED|95.0|-0.7|0.8|||||Repeated measurements Model: Change=Treatment\*Week+Baseline\*Week+Baseline IGA. Data after permanent discontinuation of IMP/initiation of rescue medication not included (4 subjects excluded). Week 2 change imputed as 0 if no post-baseline assessments.|||0.8|-0.7|
72449618|NCT04587453|144417185|OTHER|No formal testing was performed. CIs are presented with two sided 95% degree of confidence.|Mean Difference (Net)|-0.1|||||TWO_SIDED|95.0|-0.9|0.6|||||Repeated measurements model: Change=Treatment\*Week+Baseline\*Week+Baseline IGA. Data after permanent discontinuation of IMP/initiation of rescue medication not included (4 subjects excluded). Week 1 change imputed as 0 if no post-baseline assessments.|||0.6|-0.9|
72449619|NCT04587453|144417186|OTHER|No formal testing was performed. CIs are presented with two sided 95% degree of confidence.|Mean Difference (Net)|-3.2|||||TWO_SIDED|95.0|-5.6|-0.9|||||Repeated measurements model: Change=Treatment\*Week+Baseline\*Week+Baseline IGA. Data after permanent discontinuation of IMP/initiation of rescue medication not included (4 subjects excluded). Week 2 change imputed as 0 if no post-baseline assessments.|||-0.9|-5.6|
72449620|NCT03125070|144417189|SUPERIORITY|||||||0.9||||||The threshold for statistical significance was p=0.05|Chi-squared|||||||0.90
72449621|NCT03125070|144417190|SUPERIORITY|||||||0.6||||||The threshold for statistical significance was p=0.05|Chi-squared|||||||0.60
72449622|NCT03125070|144417191|OTHER|||||||0.27||||||The threshold for statistical significance was p=0.05|Chi-squared|||Sex: Female vs. Male||||0.27
72449623|NCT03125070|144417191|OTHER|||||||0.88||||||The threshold for statistical significance was p=0.05|Chi-squared|||Age \<70 vs. \>=70||||0.88
72449624|NCT03125070|144417191|OTHER|||||||0.98||||||The threshold for statistical significance was p=0.05|Chi-squared|Participants that did not answer this survey item are shown as unknwon in the table and are excluded from the statistical test.||Race and ethnicity: white AND non-Hispanic versus any other combination of race and ethnicity (BIPOC)||||0.98
72449625|NCT03125070|144417191|OTHER|||||||0.19||||||The threshold for statistical significance was p=0.05|Chi-squared|Participants that did not answer this survey item are shown as unknwon in the table and are excluded from the statistical test.||Education: High school or less versus at least some college or vocational/technical program||||0.19
72449626|NCT03125070|144417191|OTHER|||||||0.24||||||The threshold for statistical significance was p=0.05|Chi-squared|Participants that did not answer this survey item are shown as unknwon in the table and are excluded from the statistical test.||Income: \<$100,000 annual versus \>=$100,000 annual||||0.24
72449627|NCT03125070|144417191|OTHER|||||||0.28||||||The threshold for statistical significance was p=0.05|Chi-squared|Participants that did not answer the survey items for this measure are shown as unknwon in the table and are excluded from the statistical test.||PHQ score at baseline: no depression (\<10), mild depression (10-14), moderate depression (15-19), severe depression (\>=20)||||0.28
72449628|NCT03125070|144417191|OTHER|||||||0.33||||||The threshold for statistical significance was p=0.05|Chi-squared|Participants that did not answer the survey items for this measure are shown as unknwon in the table and are excluded from the statistical test.||CTXD score at baseline \<0.9 (not distressed) or \>=0.9 (distressed)||||0.33
72449629|NCT03125070|144417191|OTHER|||||||0.1||||||The threshold for statistical significance was p=0.05|Chi-squared|Participants that did not answer this survey item are shown as unknwon in the table and are excluded from the statistical test.||Cardiometabolic Healthcare Utilization (HCU-C) score at baseline: \>.80 versus \<.80||||0.10
72449630|NCT03125070|144417191|OTHER|||||||0.31||||||The threshold for statistical significance was p=0.05|Chi-squared|||Secondary cancer screening healthcare utilization (HCU-SM) at baseline: \>=.80 versus \<.80||||0.31
72449631|NCT03125070|144417192|SUPERIORITY|||||||0.89|||||||Chi-squared|||||||0.89
72449632|NCT03125070|144417193|SUPERIORITY|||||||0.4|||||||Chi-squared|||||||0.40
72449633|NCT02800356|144417217|OTHER|||||||0.404|||||||ANOVA|Analysis of Variance (ANOVA) for paired samples with Bonferroni post-hoc analysis||||||0.404
72449634|NCT02800356|144417218|OTHER|||||||0.232|||||||ANOVA|Analysis of Variance (ANOVA) for paired samples with Bonferroni post-hoc analysis||||||0.232
72449635|NCT02800356|144417219|OTHER|||||||0.001|||||||ANOVA|Analysis of Variance (ANOVA) for paired samples with Bonferroni post-hoc analysis||||||0.001
72449636|NCT02800356|144417222|OTHER|||||||0.267|||||||ANOVA|Analysis of Variance (ANOVA) for paired samples with Bonferroni post-hoc analysis||||||0.267
72449637|NCT05623228|144417228|SUPERIORITY|||||||0||||||"Bonferroni correction p\<.05~F(1.25)=9.17 η=.254 (p\<.05)"|ANOVA|||||||.00
72449638|NCT05623228|144417228|SUPERIORITY|||||||0||||||Bonferroni correction p\<.05 F(2)=7.30 η=.213 (P\<.05)|ANOVA|||||||.00
72449639|NCT05623228|144417229|SUPERIORITY|||||||0.04||||||F(2)=3.20, η=.106 Bonferroni Correction p\<.05|ANOVA|||||||.04
72449640|NCT05623228|144417230|SUPERIORITY|||||||0||||||F(1,06)=8,11, η2=.231 Bonferroni correction p\<.05|ANOVA|||||||.00
72449641|NCT05623228|144417231|SUPERIORITY|||||||0.04||||||F(1,19)=4,30, η2=.137 Bonferroni correction p\<0.5|ANOVA|||||||.04
72449642|NCT05623228|144417232|SUPERIORITY|||||||0||||||t (38.70)|t-test, 1 sided|||||||.00
72449643|NCT04625725|144417273|SUPERIORITY||Relative Risk Reduction|76.73|||<|0.001|TWO_SIDED|95.0|46.05|89.96|||Poisson regression||Estimates are based on a Poisson regression with robust variance. The model includes covariate for treatment, and age group, with the log of the follow-up time as an offset. Estimated RRR greater than 0% provides evidence in favor of AZD7442.|Primary Analysis||89.96|46.05|<0.001
72449644|NCT04625725|144417273|SUPERIORITY||Relative Risk Reduction|83.04|||<|0.001|TWO_SIDED|95.0|67.26|91.21|||Poisson regression||Estimates are based on a Poisson regression with robust variance. The model includes covariate for treatment, and age group, with the log of the follow-up time as an offset. Estimated RRR greater than 0% provides evidence in favor of AZD7442.|Final Analysis||91.21|67.26|<0.001
72449645|NCT04625725|144417275|SUPERIORITY||Relative Risk Reduction|34.9|||<|0.001|TWO_SIDED|95.0|21.44|46.05|||Poisson regression||Estimates are based on a Poisson regression with robust variance. The model includes covariate for treatment, and age group, with the log of the follow-up time as an offset. Estimated RRR greater than 0% provides evidence in favor of AZD7442.|||46.05|21.44|<0.001
72449646|NCT04625725|144417276|SUPERIORITY||Relative Risk Reduction|91.41||||0.001|TWO_SIDED|95.0|61.31|98.09|||Poisson regression||Estimates are based on a Poisson regression with robust variance. The model includes covariate for treatment, and age group, with the log of the follow-up time as an offset. Estimated RRR greater than 0% provides evidence in favor of AZD7442.|||98.09|61.31|0.001
72449647|NCT04625725|144417277|SUPERIORITY||Relative Risk Reduction|52.43||||0.137|TWO_SIDED|95.0|-26.61|82.13|||Poisson regression|||||82.13|-26.61|0.137
72449648|NCT03298451|144417282|SUPERIORITY|||||||0.0035||||||The adjusted alpha levels (0.0398) for the two-sided superiority test were derived based upon the exact number of OS events for each comparison using the Lan and DeMets approach that approximates the O'Brien Fleming spending function.|Log Rank|||The analysis was performed using stratified log-rank test adjusting for treatment, etiology of liver disease (HBV versus HCV versus others), ECOG (0 versus 1), and macro-vascular invasion (yes versus no). The values of the stratification factors were obtained from IVRS.||||0.0035
72449649|NCT03298451|144417282|SUPERIORITY||Hazard Ratio (HR)|0.78|||||TWO_SIDED|95.0|0.66|0.92|||Regression, Cox|||The analysis was performed using a Cox proportional hazards model adjusting for treatment, etiology of liver disease (HBV versus HCV versus others), ECOG (0 versus 1), and macro-vascular invasion (yes versus no). Values of the variables used for adjustment were obtained from IVRS.||0.92|0.66|
72449650|NCT03298451|144417283|NON_INFERIORITY|Non-interiority for the comparison of arm Durva 1500 mg vs Sora 400 mg is declared if the upper limit of the two-sided alpha adjusted CI for HR is less than the NI margin of 1.08.|Hazard Ratio (HR)|0.86|||||TWO_SIDED|95.67|0.73|1.03|||Regression, Cox||The 95.67% confidence interval were derived based upon the exact number of OS events for each comparison using the Lan and DeMets approach that approximates the O'Brien Fleming spending function.|The analysis was performed using a Cox proportional hazards model adjusting for treatment, etiology of liver disease (HBV versus HCV versus others), ECOG (0 versus 1), and macro-vascular invasion (yes versus no). Values of the variables used for adjustment were obtained from IVRS.||1.03|0.73|
72449651|NCT03298451|144417283|SUPERIORITY|Superiority was tested sequentially per protocol as non-inferiority was satisfied.||||||0.0674||||||The adjusted alpha levels (0.0433) for the two-sided superiority test were derived based upon the exact number of OS events for each comparison using the Lan and DeMets approach that approximates the O'Brien Fleming spending function.|Log Rank|||The analysis was performed using stratified log-rank test adjusting for treatment, etiology of liver disease (HBV versus HCV versus others), ECOG (0 versus 1), and macro-vascular invasion (yes versus no). The values of the stratification factors were obtained from IVRS.||||0.0674
72449652|NCT04231331|144417299|SUPERIORITY||||||<|0.001||||||P-value \<0.05 was considered statistically significant.|t-test, 2 sided|||Based on our previous study, we assumed a common baseline mean EROA of 0.21 cm2 with a common standard deviation of 0.11 cm2. Given these assumptions, we calculated that a sample size of 204 patients randomly assigned to two groups, would provide 90% power to detect a difference of 0.05 cm2 in the EROA between the ertugliflozin and placebo groups, using a two-sided t test with an alpha level of 0.05.||||<0.001
72449653|NCT05873556|144417316|SUPERIORITY|Generalized linear mixed model was estimated using a sample of N=93 with a Condition × 2-Week Follow-Up interaction. AOC was the reference category for Condition, and Baseline was the reference category for 2-Week Follow-Up.|Count/Rate Ratio|0.97||||0.83|TWO_SIDED|95.0|0.74|1.27|||Generalized linear mixed model|Models controlled for sex assigned at birth, age, and student status (4-year vs. not) and used a Poisson error distribution.||Changes from Baseline to 2-Week Follow-Up for PFI versus AOC reported in this section.||1.27|0.74|0.83
72449654|NCT05873556|144417316|SUPERIORITY|Generalized linear mixed model was estimated using a sample of N=93 with a Condition × 3-Month Follow-Up interaction. AOC was the reference category for Condition, and Baseline was the reference category for 3-Month Follow-Up.|Count/Rate Ratio|1.07||||0.61|TWO_SIDED|95.0|0.83|1.38|||Generalized linear mixed model|Models controlled for sex assigned at birth, age, and student status (4-year vs. not) and used a Poisson error distribution.||Changes from Baseline to 3-Month Follow-Up for PFI versus AOC reported in this section.||1.38|0.83|0.61
72449655|NCT05873556|144417317|SUPERIORITY|Generalized linear mixed model was estimated using a sample of N=93 with a Condition × 2-Week Follow-Up interaction. AOC was the reference category for Condition, and Baseline was the reference category for 2-Week Follow-Up.|Count/Rate Ratio|1.16||||0.45|TWO_SIDED|95.0|0.79|1.72|||Generalized linear mixed model|Models controlled for sex assigned at birth, age, and student status (4-year vs. not) and used a Poisson error distribution.||Changes from Baseline to 2-Week Follow-Up for PFI versus AOC reported in this section.||1.72|0.79|0.45
72449656|NCT05873556|144417317|SUPERIORITY|Generalized linear mixed model was estimated using a sample of N=93 with a Condition × 3-Month Follow-Up interaction. AOC was the reference category for Condition, and Baseline was the reference category for 3-Month Follow-Up.|Count/Rate Ratio|1.17||||0.46|TWO_SIDED|95.0|0.77|1.79|||Generalized linear mixed model|Models controlled for sex assigned at birth, age, and student status (4-year vs. not) and used a Poisson error distribution.||Changes from Baseline to 3-Month Follow-Up for PFI versus AOC reported in this section.||1.79|0.77|0.46
72449657|NCT05873556|144417318|SUPERIORITY|Generalized linear mixed model was estimated using a sample of N=93 with a Condition × 2-Week Follow-Up interaction. AOC was the reference category for Condition, and Baseline was the reference category for 2-Week Follow-Up.|Count/Rate Ratio|0.95||||0.62|TWO_SIDED|95.0|0.77|1.17|||Generalized linear mixed model|Models controlled for sex assigned at birth, age, and student status (4-year vs. not) and used a Poisson error distribution.||Changes from Baseline to 2-Week Follow-Up for PFI versus AOC reported in this section.||1.17|0.77|0.62
72449658|NCT05873556|144417318|SUPERIORITY|Generalized linear mixed model was estimated using a sample of N=93 with a Condition × 3-Month Follow-Up interaction. AOC was the reference category for Condition, and Baseline was the reference category for 3-Month Follow-Up.|Count/Rate Ratio|1.14||||0.34|TWO_SIDED|95.0|0.87|1.48|||Generalized linear mixed model|Models controlled for sex assigned at birth, age, and student status (4-year vs. not) and used a Poisson error distribution.||Changes from Baseline to 3-Month Follow-Up for PFI versus AOC reported in this section.||1.48|0.87|0.34
72449659|NCT05873556|144417319|SUPERIORITY|Generalized linear mixed model was estimated using a sample of N=93 with a Condition × 2-Week Follow-Up interaction. AOC was the reference category for Condition, and Baseline was the reference category for 2-Week Follow-Up.|Count/Rate Ratio|1.08||||0.66|TWO_SIDED|95.0|0.76|1.54|||Generalized linear mixed model|Models controlled for sex assigned at birth, age, and student status (4-year vs. not) and used a Poisson error distribution.||Changes from Baseline to 2-Week Follow-Up for PFI versus AOC reported in this section.||1.54|0.76|0.66
72469681|NCT03635086|144463054|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|0.6||||0.8916|TWO_SIDED|95.0|0.1|3.1|||ANOVA|||Day 182||3.1|0.1|0.8916
72619573|NCT01644331|144770011|SUPERIORITY_OR_OTHER||Slope|-0.67||||0.241|TWO_SIDED|95.0|-1.79|0.45|||Mixed Models Analysis|||This is a repeated measures analysis so all rows (visits) are taken into account.||0.45|-1.79|0.241
72370243|NCT03001817|144251002|SUPERIORITY|||||||0.0374|||||||Hodges-Lehmann method|||||||0.0374
72370244|NCT03001817|144251003|SUPERIORITY|||||||0.7429|||||||Hodges-Lehmann method|||||||0.7429
72370245|NCT03001817|144251004|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<.0001
72370246|NCT03001817|144251005|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<.0001
72370247|NCT03001817|144251006|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<.0001
72370248|NCT03001817|144251007|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<.0001
72449660|NCT05873556|144417319|SUPERIORITY|Generalized linear mixed model was estimated using a sample of N=93 with a Condition × 3-Month Follow-Up interaction. AOC was the reference category for Condition, and Baseline was the reference category for 3-Month Follow-Up.|Count/Rate Ratio|1.02||||0.92|TWO_SIDED|95.0|0.75|1.38|||Generalized linear mixed model|Models controlled for sex assigned at birth, age, and student status (4-year vs. not) and used a Poisson error distribution.||Changes from Baseline to 3-Month Follow-Up for PFI versus AOC reported in this section.||1.38|0.75|0.92
72449661|NCT02398656|144417343|SUPERIORITY||Risk Ratio (RR)|0.96|||||TWO_SIDED|95.0|0.88|1.04||||||||1.04|0.88|
72561870|NCT00781079|144654472|SUPERIORITY_OR_OTHER|||||||0.5|TWO_SIDED|||||Models included site, age, race, ethnicity.|Regression, Linear|||comparisons between the PS and Usual Care groups were completed with a regression testing the interaction of group (PS vs Usual Care) and time (baseline vs follow-up) for the outcome measure. The measure was analyzed with mixed effect hierarchical regressions which accounted for the nesting of site under treatment, subjects within sites, and subjects over time.||||.5
72619574|NCT01644331|144770012|SUPERIORITY_OR_OTHER||Slope|0.28||||0.303|TWO_SIDED|95.0|-0.26|0.82|||Mixed Models Analysis|||This is a repeated measures analysis so all rows (visits) are taken into account.||0.82|-0.26|0.303
72619575|NCT01644331|144770013|SUPERIORITY_OR_OTHER|||||||0.471||||||24 hours|Chi-squared|||||||0.471
72449662|NCT02038777|144417357|OTHER||||||<|0.0001||||||An exact test for a single proportion (1-sided significance level: 0.05) was used.|Exact test for a single proportion|||||||<.0001
72449663|NCT04299464|144417430|SUPERIORITY||Difference in Adjusted Mean|-0.432||||0.765|TWO_SIDED|80.0|-2.291|1.428|||ANCOVA|||||1.428|-2.291|0.7650
72561871|NCT00781079|144654473|SUPERIORITY||Z tests if Reg coeff are diff from 0|-0.58||||0.56|TWO_SIDED||||||Regression, Linear|||||||.56
72619576|NCT01644331|144770013|SUPERIORITY_OR_OTHER|||||||0.585||||||48 hrs|Chi-squared|||||||0.585
72370249|NCT03001817|144251008|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<.0001
72370250|NCT03001817|144251009|SUPERIORITY|||||||0.3669|||||||Hodges-Lehmann method|||||||0.3669
72370251|NCT03001817|144251010|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<.0001
72449664|NCT04299464|144417430|SUPERIORITY||Difference in Adjusted Mean|-0.4444||||0.7517|TWO_SIDED|80.0|-2.25|1.363|||ANCOVA|||||1.363|-2.250|0.7517
72449665|NCT04299464|144417439|SUPERIORITY||Difference in Adjusted Mean|1.741||||0.6082|TWO_SIDED|80.0|-2.631|6.114|||ANCOVA|||||6.114|-2.631|0.6082
72449666|NCT04299464|144417439|SUPERIORITY||Difference in Adjusted Mean|-1.715||||0.6228|TWO_SIDED|80.0|-6.204|2.774|||ANCOVA|||||2.774|-6.204|0.6228
72449667|NCT04299464|144417440|SUPERIORITY||Difference in Adjusted Mean|-2.983||||0.1987|TWO_SIDED|80.0|-5.957|-0.009|||ANCOVA|||||-0.009|-5.957|0.1987
72449668|NCT04299464|144417440|SUPERIORITY||Difference in Adjusted Mean|-4.474||||0.046|TWO_SIDED|80.0|-7.326|-1.622|||ANCOVA|||||-1.622|-7.326|0.0460
72449669|NCT04299464|144417441|SUPERIORITY||Difference in Adjusted Means|1.279||||0.4746|TWO_SIDED|80.0|-1.021|3.578|||ANCOVA|||||3.578|-1.021|0.4746
72449670|NCT04299464|144417441|SUPERIORITY||Difference in Adjusted Means|2.697||||0.1244|TWO_SIDED|80.0|0.453|4.94|||ANCOVA|||||4.940|0.453|0.1244
72449671|NCT03676192|144417442|EQUIVALENCE|The similarity criterion had been set such that the confidence limits of the 95% confidence interval (CI) of the difference of ORR from each treatment group was entirely bounded by the interval (-12.5, 12.5).|Risk Difference (RD)|0.4|||||TWO_SIDED|95.0|-7.02|7.83||||||Logistic regression model including treatment groups (CT-P16 and EU-approved Avastin) as a fixed effect and region (EMEA vs. America vs. Asia), sex (female vs. male), disease status at baseline (recurrence vs. metastatic), and ECOG performance score at baseline (0 vs. 1) as covariates was used.||7.83|-7.02|
72449672|NCT03676192|144417442|EQUIVALENCE|The similarity criterion had been set such that the confidence limits of the 90% confidence interval (CI) of the ratio of ORR from each treatment group was entirely bounded by the interval (0.7368, 1.3572).|Risk Ratio (RR)|1.0136|||||TWO_SIDED|90.0|0.8767|1.1719||||||Log-binomial regression model including treatment groups (CT-P16 and EU-approved Avastin) as a fixed effect and region (EMEA vs. America vs. Asia), sex (female vs. male), disease status at baseline (recurrence vs. metastatic), and ECOG performance score at baseline (0 vs. 1) as covariates was used.||1.1719|0.8767|
72449673|NCT03676192|144417445|OTHER||Hazard Ratio (HR)|0.92|||||TWO_SIDED|95.0|0.77|1.1||||||Adjusted stratified Cox regression model is used to estimate the hazard ratio and its 95% CI for receiving CT-P16 compared with receiving EU-approved Avastin using region (EMEA vs. America vs. Asia), sex (female vs. male), disease status at baseline (recurrence vs. metastatic), and ECOG performance score at baseline (0 vs. 1) as stratification factors.||1.10|0.77|
72449674|NCT03676192|144417446|OTHER||Hazard Ratio (HR)|0.95|||||TWO_SIDED|95.0|0.77|1.19||||||Adjusted stratified Cox regression model is used to estimate the hazard ratio and its 95% CI for receiving CT-P16 compared with receiving EU-approved Avastin using region (EMEA vs. America vs. Asia), sex (female vs. male), disease status at baseline (recurrence vs. metastatic), and ECOG performance score at baseline (0 vs. 1) as stratification factors.||1.19|0.77|
72619577|NCT01644331|144770013|SUPERIORITY_OR_OTHER|||||||0.12||||||72 hrs|Chi-squared|||||||0.120
72619578|NCT01644331|144770014|SUPERIORITY_OR_OTHER|||||||0.037|||||||Chi-squared|||||||0.037
72619579|NCT01644331|144770015|SUPERIORITY_OR_OTHER|||||||0.373|||||||Wilcoxon (Mann-Whitney)|||||||0.373
72619580|NCT01644331|144770016|SUPERIORITY_OR_OTHER||Kaplan Meier|0.26||||0.709|TWO_SIDED|95.0|0.21|0.32|||Log Rank|||||0.32|0.21|0.709
72619581|NCT02327143|144770019|SUPERIORITY_OR_OTHER||Ratio of geometric least squares|0.448|||||TWO_SIDED|90.0|0.395|0.508|||||Absolute bioavailability of LY2835219 following the administration of 200 mg LY2835219 (oral) with 0.4 mg \[13C8\]-LY2835219 (IV).|||0.508|0.395|
72619582|NCT02070380|144770023|SUPERIORITY_OR_OTHER||∆Percentage MH better minus DM better|47.6|||<|0.0001|TWO_SIDED|95.0|34.5|60.7||Only 1 primary endpoint, no adjustment for multiple comparisons and the a priori threshold for statistical significance was 0.05.|Wilcoxon signed-rank test.||Difference in percentage MultiHance better minus percentage Dotarem better (%) , 2-sided 95% confidence interval was estimated using Altman's general approximate normal method.|"Null hypotheses:~A 0.1 mmol/kg dose of MULTIHANCE is equal to a 0.1 mmol/kg dose of DOTAREM, in terms of the assessment of global diagnostic preference in an off-site pre-dose plus postdose paired global assessment."||60.7|34.5|<0.0001
72622423|NCT01854762|144774800|OTHER||Odds Ratio (OR)|3.1|||<|0.01|TWO_SIDED|95.0|1.3|7.4|||Fisher Exact||||Kaplan-Meier estimates for the proportion of patients without virological failure by weeks 2, 4 and 6, and at delivery, using treatment-related discontinuation equal failure analysis|7.4|1.3|<0.01
72561872|NCT00781079|144654474|SUPERIORITY_OR_OTHER|||||||0.05|TWO_SIDED|||||Models included site, age, race, ethnicity. This is the calculated p value.|Regression, Linear|||comparisons between the PS and Usual Care groups were completed with a regression testing the interaction of group (PS vs Usual Care) and time (baseline vs follow-up) for the outcome measure. The measure was analyzed with mixed effect hierarchical regressions which accounted for the nesting of site under treatment, subjects within sites, and subjects over time.||||.05
72561873|NCT00781079|144654475|SUPERIORITY||Z test if reg coeff is diff from 0|0.56||||0.58|TWO_SIDED||||||Regression, Linear|||||||.58
72449675|NCT05907174|144417449|SUPERIORITY||B|-2.23||||0.023|TWO_SIDED||||||Regression, Linear|||||||0.023
72449676|NCT04685135|144417489|SUPERIORITY||Hazard Ratio (HR)|0.58|||<|0.0001|TWO_SIDED|95.0|0.45|0.76|||Log Rank|HR and CI are from stratified Cox proportional hazard model||||0.76|0.45|<0.0001
72449677|NCT04685135|144417491|SUPERIORITY||Odds Ratio (OR)|4.68|||<|0.0001|TWO_SIDED|95.0|2.56|8.56|||Cochran Mantel Haenszel chi-square test|||||8.56|2.56|<0.0001
72449678|NCT04726371|144417513|SUPERIORITY|||||||0.89||||||A Wald test was used to test against the null hypothesis that intervention main effect and interaction effects between intervention and time trends were simultaneously zero and assess for differences in the mean trend of infections over follow-up.|Test of joint null hypothesis from model|Bonferroni-adjusted p-value is reported to correct for multiplicity for testing outcomes with 6 combinations of outcomes and subpopulations.||A Poisson GLMM was fit with a main effect for intervention group, linear and quadratic time trends, and interaction effects between intervention and the time trend variables. The model was adjust for stratification factors, baseline infection incidence, agency and included random intercept for group home.|"The point estimates for intervention main effect, intervention by linear time effect, and for intervention by time\^2 interaction effect are described in the paper Tailored vs. General COVID-19 prevention for adults with mental disabilities residing in group homes: a randomized controlled effectiveness-implementation trial by Bartels S, Levison JH, Trieu HD, et al., published in 2024 in BMC Public Health, doi:10.1186/s12889-024-18835-w."|||0.89
72449679|NCT04726371|144417514|SUPERIORITY||||||>|0.99||||||A Wald test was used to test against the null hypothesis that intervention main effect and interaction effects between intervention and time trends were simultaneously zero and assess for differences in the mean trend of scores over follow-up.|Wald test|Bonferroni-adjusted p-value is reported to correct for multiplicity for testing outcomes with 6 combinations of outcomes and subpopulations.||A GLMM was fit with a main effect for intervention group, linear and quadratic time trends, and interaction effects between intervention and the time trend variables. The model was adjust for stratification factors, baseline fidelity score, agency and included random intercept for group home.|"The point estimates for intervention main effect, intervention by linear time effect, and intervention by time\^2 interaction effect are described in the paper Tailored vs. General COVID-19 prevention for adults with mental disabilities residing in group homes: a randomized controlled effectiveness-implementation trial by Bartels S, Levison JH, Trieu HD, et al., published in 2024 in BMC Public Health, doi:10.1186/s12889-024-18835-w."|||>.99
72449680|NCT04726371|144417515|SUPERIORITY||Hazard Ratio (HR)|1.21|||>|0.99|TWO_SIDED|95.0|0.79|1.84||Bonferroni-adjusted p-value is reported to correct for multiplicity for testing outcomes with 6 combinations of outcomes and subpopulations.|Regression, Cox|||A Cox frailty model was fit to evaluate differences in the hazard of vaccination uptake between arms separately within the combined population of residents with SMI and ID/DD. This model included a main effect for intervention arm and additionally adjusted for stratification factors, GH agency, and GH-level log-normal frailties.||1.84|0.79|>.99
72449681|NCT04726371|144417516|SUPERIORITY||Hazard Ratio (HR)|0.99|||>|0.99|TWO_SIDED|95.0|0.86|1.15||Bonferroni-adjusted p-value is reported to correct for multiplicity for testing outcomes with 6 combinations of outcomes and subpopulations.|Regression, Cox|||A Cox frailty model was fit to evaluate differences in the hazard of vaccination uptake between arms separately within the staff population. This model included a main effect for intervention arm and additionally adjusted for stratification factors, GH agency, and GH-level log-normal frailties.||1.15|0.86|>.99
72449682|NCT04911296|144417554|OTHER|||||||0.935|||||||Fisher Exact|||||||0.935
72449683|NCT04911296|144417555|OTHER|||||||0.536|||||||Fisher Exact|||||||0.536
72449684|NCT05086796|144417652|SUPERIORITY||Risk Ratio (RR)|2.1|||||TWO_SIDED|97.5|1.51|2.91|||||The START arm is the numerator, Usual Care is the denominator. There are two primary outcome measures, so the type I error level was adjusted to alpha = 0.025.||Poisson regression was used to compare the proportions of participants who initiated MOUD in the hospital by calculating the risk ratio (RR) and 97.5% confidence interval (CI) and with covariates treatment arm, site (3 sites), prior exposure to MOUD (yes vs. no), and length of hospital stay in days.|2.91|1.51|
72449685|NCT05086796|144417653|SUPERIORITY||Risk Ratio (RR)|1.49|||||TWO_SIDED|97.5|1.15|1.93|||||The START arm is the numerator, Usual Care is the denominator. There are two primary outcome measures, so the type I error level was adjusted to alpha = 0.025.||Poisson regression was used to compare the proportions of participants who linked to follow-up OUD care by calculating the risk ratio (RR) and 97.5% confidence interval (CI) and with covariates treatment arm, site (3 sites), and prior exposure to MOUD (yes vs. no).|1.93|1.15|
72449686|NCT05086796|144417654|SUPERIORITY||Risk Ratio (RR)|1.8|||||TWO_SIDED|95.0|1.35|2.41|||||The START arm is the numerator, Usual Care is the denominator.||Multivariable Poisson regression was used to compare the proportions of participants who initiated MOUD in the hospital between arms by calculating the risk ratio (RR) and 95% confidence interval (CI) with covariates: treatment arm, site (3 sites), and prior exposure to MOUD (yes vs. no).|2.41|1.35|
72561874|NCT00781079|144654476|SUPERIORITY||Z test if reg coeff is diff than 0|-0.16||||0.87|TWO_SIDED||||||Regression, Linear|||||||.87
72622424|NCT02514746|144774838|OTHER||Difference (Group A - B)|-0.6|||||TWO_SIDED|95.0|-7.5|4.5||||||Difference at Year 3||4.5|-7.5|
72561875|NCT00781079|144654477|SUPERIORITY||Z test if ref coeff is diff than 0|0.03||||0.98|TWO_SIDED||||||Regression, Linear|||||||.98
72561876|NCT00345033|144654478|NON_INFERIORITY_OR_EQUIVALENCE|A priori power calculation determined the power to detect a change in total cholesterol is over 99%.||||||0.125||95.0|||||ANCOVA|||||||0.125
72622425|NCT02514746|144774838|OTHER||Difference (Group A - B)|0.6|||||TWO_SIDED|95.0|-7.4|6.5||||||Difference at Year 4||6.5|-7.4|
72370252|NCT03001817|144251011|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<.0001
72622426|NCT02514746|144774839|OTHER||GMT Ratio (Group A/B)|1.0|||||TWO_SIDED|95.0|0.9|1.1||||||Geometric mean titer ratio at Year 3||1.1|0.9|
72449687|NCT05086796|144417655|SUPERIORITY||Risk Ratio (RR)|1.71|||||TWO_SIDED|95.0|1.23|2.39|||||The START arm is the numerator, Usual Care is the denominator.||Multivariable Poisson regression was used to compare the proportions of participants who reported any post-discharge MOUD utilization between arms by calculating the risk ratio (RR) and 95% confidence interval (CI) with covariates: treatment arm, site (3 sites), and prior exposure to MOUD (yes vs. no).|2.39|1.23|
72449688|NCT05086796|144417656|SUPERIORITY||Risk Ratio (RR)|1.89|||||TWO_SIDED|95.0|1.18|3.03|||||The START arm is the numerator, Usual Care is the denominator.||Multivariable Poisson regression was used to compare the proportions of participants who reported receiving any post-discharge outpatient medical care for their OUD between arms by calculating the risk ratio (RR) and 95% confidence interval (CI) with covariates: site (3 sites), and prior exposure to MOUD (yes vs. no).|3.03|1.18|
72449689|NCT05086796|144417657|SUPERIORITY||Incident rate ratio|1.25|||||TWO_SIDED|95.0|0.64|2.43|||||The START arm is the numerator, Usual Care is the denominator.||Multivariable negative binomial regression with a log link function was used to compare opioid use-days between the two treatment arms by calculating the incident rate ratio (IRR) and 95% confidence interval (CI) with covariates: site (3 sites), prior exposure to MOUD (yes vs. no), and baseline opioid use days.|2.43|0.64|
72449690|NCT03295721|144417658|SUPERIORITY||Least Squares Mean Difference (LSMD)|-122.05|STANDARD_ERROR_OF_MEAN|21.217|<|0.0001|TWO_SIDED|95.0|-163.76|-80.34|||ANOVA|||||-80.34|-163.76|< 0.0001
72498832|NCT01817790|144527893|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-0.44|||<|0.0001|TWO_SIDED|95.0|-0.65|-0.23||p-value was not adjusted for multiple comparisons.|ANCOVA|Linear Fixed-effect Model; Treatment and site as fixed factors and baseline score as covariate.||Null hypothesis was that no difference exists in the mean change from baseline in 'Eye Symptoms' domain of MiniRQLQ scores between the Flutical sone nasal spray and placebo nasal spray.||-0.23|-0.65|<0.0001
72498833|NCT01817790|144527894|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-0.42|||<|0.0001|TWO_SIDED|95.0|-0.64|-0.21||p-value was not adjusted for multiple comparisons.|ANCOVA|||Null hypothesis was that no difference exists in the mean change from baseline in 'Other Symptoms' domain of MiniRQLQ scores between the Flutical sone nasal spray and placebo nasal spray.||-0.21|-0.64|<0.0001
72498834|NCT04596891|144527899|OTHER|Repeated measures ANOVA|F ratio|20.62|||<|0.001|TWO_SIDED|95.0|||||ANOVA||The F ratio is used to evaluate the main effect of time in the ANOVA in relation to the critical F ratio.|No control group, open trial for feasibility/safety||||<0.001
72498835|NCT04596891|144527899|OTHER|Paired-samples t-test (baseline to post-treatment)|paired-samples t-test|5.2||||0.002|TWO_SIDED|95.0|-1.79|12.93|||t-test, 2 sided|||||12.93|-1.79|0.002
72561877|NCT00345033|144654479|NON_INFERIORITY_OR_EQUIVALENCE|A priori power calculation determined the power to detect a change in weight will be over 99%.||||||0.109||95.0|||||ANCOVA|||||||0.109
72561878|NCT00345033|144654480|NON_INFERIORITY_OR_EQUIVALENCE|A priori power calculation determined the power to detect a change in Body Mass Index (BMI) will be over 99%.||||||0.229||95.0|||||ANCOVA|||||||0.229
72561879|NCT00345033|144654481|NON_INFERIORITY_OR_EQUIVALENCE|A priori power calculation determined the power to detect a change in glucose metabolism to be 90%.||||||0.01||95.0|||||ANCOVA|||||||0.010
72561880|NCT00345033|144654482|NON_INFERIORITY_OR_EQUIVALENCE|A priori power calculation determined the power to detect a change in triglycerides will be 81%.||||||0.982||95.0|||||ANCOVA|||||||0.982
72561881|NCT00345033|144654483|NON_INFERIORITY_OR_EQUIVALENCE|A priori power calculation determined the power to detect a change in Insulin Resistance will be 90%.||||||0.082||95.0|||||ANCOVA|||||||0.082
72561882|NCT04979858|144654582|OTHER|The statistical analysis involved the use of a single-factor ANOVA test to assess the importance of the various factors associated with the design of the Focal Mask (the Treatment) that would impact its performance in reducing the spread of COVID-19, which is caused by the SARS-CoV-2 virus. The Bonferroni t-test was conducted post hoc to assess the statistical significance of the various factors.|||||<|0.01|||||||ANOVA|||||||<0.01
72561883|NCT02418754|144654619|SUPERIORITY|Analysis was performed using analysis of covariance (ANCOVA) model with baseline measurements as covariate and treatment group, baseline angiographic choroidal neovascularization (CNV) subtype (predominantly or minimally classic versus occult versus occult with no classic lesions) as fixed factors.|Least Squares (LS) Mean Difference|-1.58||||0.2052|TWO_SIDED|95.0|-4.37|1.22||Threshold for significance at 0.025 level.|ANCOVA|||To control for the family-wise type I error rate of 5%, for each of the 2 REGN2176-3 groups the 2-sided hypothesis comparing REGN2176-3 (1 mg: 2 mg) vs. Intravitreal Aflibercept Injection (IAI) 2 mg was tested at a significance level of α = 2.5%.||1.22|-4.37|0.2052
72370253|NCT03001817|144251012|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<.0001
72370254|NCT03001817|144251013|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<.0001
72449691|NCT03295721|144417659|SUPERIORITY||Least Squares Mean Difference (LSMD)|-70.16|STANDARD_ERROR_OF_MEAN|18.777|=|0.0002|TWO_SIDED|95.0|-107.07|-33.25|||ANOVA|||||-33.25|-107.07|= 0.0002
72449692|NCT03295721|144417660|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||< 0.0001
72449693|NCT03295721|144417661|SUPERIORITY||Risk Difference (RD)|0.177||||0.0001|TWO_SIDED|95.0|0.085|0.265|||Fisher Exact|||||.265|.085|0.0001
72449694|NCT03295721|144417662|SUPERIORITY||||||=|0.0022|||||||Wilcoxon (Mann-Whitney)|||||||= 0.0022
72498836|NCT04596891|144527904|OTHER|ANOVA|F ratio|8.46|||<|0.001|TWO_SIDED|95.0|||||ANOVA||The F ratio is used to evaluate the main effect of time in the ANOVA in relation to the critical F ratio. If it exceeds the critical F ratio, the null hypothesis (no effect of time) is rejected.|||||<0.001
72498837|NCT04533711|144527928|SUPERIORITY||Mean Difference (Final Values)|8.35||||0.3086|TWO_SIDED|95.0|-7.68|24.38|||Mixed Models Analysis|||||24.38|-7.68|0.3086
72498838|NCT04533711|144527929|SUPERIORITY||Mean Difference (Final Values)|10.93||||0.182|TWO_SIDED|95.0|-5.06|26.92|||Mixed Models Analysis|||||26.92|-5.06|0.1820
72561884|NCT02418754|144654619|SUPERIORITY|Analysis was performed using ANCOVA model with baseline measurements as covariate and treatment group, baseline angiographic choroidal neovascularization (CNV) subtype (predominantly or minimally classic versus occult versus occult with no classic lesions) as fixed factors.|Least Squares (LS) Mean Difference|-1.7||||0.0982|TWO_SIDED|95.0|-4.0|0.61||Threshold for significance at 0.025 level.|ANCOVA|||To control for the family-wise type I error rate of 5%, for each of the 2 REGN2176-3 groups the 2-sided hypothesis comparing REGN2176-3 (1 mg: 2 mg) vs. Intravitreal Aflibercept Injection (IAI) 2 mg was tested at a significance level of α = 2.5%.||0.61|-4.00|0.0982
72622427|NCT02514746|144774839|OTHER||GMT Ratio (Group A/B)|1.0|||||TWO_SIDED|95.0|0.9|1.1||||||Geometric mean titer ratio at Year 4||1.1|0.9|
72449695|NCT01651403|144417676|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|2-sided Cochran-Mantel-Haenszel test adjusted for age at baseline and region strata||||||< 0.001
72449696|NCT01651403|144417676|SUPERIORITY||||||<|0.001|||||||Fisher Exact|Fisher's exact test without adjusting for strata at baseline||||||< 0.001
72449697|NCT01651403|144417677|SUPERIORITY|||||||0.935|||||||Cochran-Mantel-Haenszel|2-sided Cochran-Mantel-Haenszel test adjusted for age at baseline and region strata||||||0.935
72449698|NCT01651403|144417678|SUPERIORITY|||||||0.001|||||||Cochran-Mantel-Haenszel|2-sided Cochran-Mantel-Haenszel tests adjusted for age at baseline and region strata||||||0.001
72449699|NCT01651403|144417680|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|2-sided Cochran-Mantel-Haenszel tests adjusted for age at baseline and region strata||||||<0.001
72449700|NCT01651403|144417682|SUPERIORITY|||||||0.002|||||||Cochran-Mantel-Haenszel|2-sided Cochran-Mantel-Haenszel tests adjusted for age at baseline and region strata||||||0.002
72449701|NCT01651403|144417684|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|2-sided Cochran-Mantel-Haenszel tests adjusted for age at baseline and region strata||||||<0.001
72498839|NCT04533711|144527930|SUPERIORITY||Mean Difference (Final Values)|308.4||||0.094|TWO_SIDED|95.0|-50.2|667.1|||Mixed Models Analysis|||||667.1|-50.2|0.094
72498840|NCT04533711|144527931|SUPERIORITY||Mean Difference (Final Values)|352.0||||0.0691|TWO_SIDED|95.0|-25.2|729.2|||Mixed Models Analysis|||||729.2|-25.2|0.0691
72498841|NCT04533711|144527932|SUPERIORITY||Mean Difference (Final Values)|-5.85||||0.4953|TWO_SIDED|95.0|-22.6|10.94|||Mixed Models Analysis|||||10.94|-22.6|0.4953
72622428|NCT02514746|144774840|OTHER||Difference (Group A - B)|-3.7|||||TWO_SIDED|95.0|-8.1|2.8||||||Difference at 7 days post booster vaccination||2.8|-8.1|
72449702|NCT01651403|144417686|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|2-sided Cochran-Mantel-Haenszel tests adjusted for age at baseline and region strata||||||<0.001
72449703|NCT01651403|144417688|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|2-sided Cochran-Mantel-Haenszel tests adjusted for age at baseline and region strata||||||<0.001
72449704|NCT01651403|144417690|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|two-sided Cochran-Mantel-Haenszel test adjusted for age at baseline and region strata||||||<0.001
72449705|NCT01651403|144417692|SUPERIORITY||||||>|0.999|||||||Cochran-Mantel-Haenszel|Two-sided Cochran-Mantel-Haenszel test adjusted for age at baseline and region strata||||||>0.999
72449706|NCT01651403|144417700|OTHER|Comparison of the difference in percentages|Exact Chan-Zhang method|11.4|||||TWO_SIDED|95.0|-6.9|25.1||||||||25.1|-6.9|
72449707|NCT01651403|144417701|OTHER|Comparison of the difference in percentages|Exact Chan-Zhang method|11.4|||||TWO_SIDED|95.0|-6.9|25.1||||||||25.1|-6.9|
72449708|NCT01651403|144417702|SUPERIORITY|||||||0.007|||||||ANOVA|two-sided superiority test||||||0.007
72449709|NCT01651403|144417704|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|2-sided Cochran-Mantel-Haenszel test adjusted for age at baseline and region strata||||||<0.001
72449710|NCT04484428|144417808|SUPERIORITY|||||||0.773|||||||ANCOVA|||||||0.773
72449711|NCT04484428|144417809|SUPERIORITY|||||||0.972|||||||ANCOVA|||||||0.972
72449712|NCT04484428|144417810|SUPERIORITY|||||||0.617|||||||ANCOVA|||||||0.617
72449713|NCT04484428|144417811|SUPERIORITY|||||||0.796|||||||ANCOVA|||||||0.796
72449714|NCT04484428|144417812|SUPERIORITY|||||||0.96|||||||ANCOVA|||||||0.960
72449715|NCT04484428|144417813|SUPERIORITY|||||||0.761|||||||ANCOVA|||||||0.761
72449716|NCT04484428|144417814|SUPERIORITY|||||||0.979|||||||ANCOVA|||||||0.979
72449717|NCT04484428|144417815|SUPERIORITY|||||||0.803|||||||ANCOVA|||||||0.803
72449718|NCT03825588|144417816|SUPERIORITY|||||||0.71||||||False Discovery Rate q-value \> 0.99|Chi-squared|||Compare participants receiving ASAP (ASAP+TAU and ASAP+BRITE+TAU) to those who do not (BRITE+TAU and TAU) on the rate of actual suicide attempts||||0.71
72449719|NCT03825588|144417816|SUPERIORITY|||||||0.43||||||False Discovery Rate q-vale \> 0.99|Chi-squared|||Compare participants receiving BRITE (BRITE+TAU and ASAP+BRITE+TAU) to those who do not (ASAP+TAU and TAU) on the rate of actual suicide attempts||||0.43
72449720|NCT03825588|144417816|SUPERIORITY||Odds Ratio (OR)|0.4||||0.21|TWO_SIDED|95.0|0.1|1.66||False Discovery Rate q-value \> 0.99|Regression, Logistic|||Compare the 4 arms on the rate of actual suicide attempts in a 2x2 factorial design. Interaction effect of ASAP and BRITE.||1.66|0.10|0.21
72449721|NCT03825588|144417816|SUPERIORITY||Odds Ratio (OR)|1.31||||0.57|TWO_SIDED|95.0|0.51|3.34||False Discovery Rate q-value \> 0.99|Regression, Logistic|||Compare the 4 arms on the rate of actual suicide attempts in a 2x2 factorial design. Main effect of ASAP||3.34|0.51|0.57
72449722|NCT03825588|144417816|SUPERIORITY||Odds Ratio (OR)|1.15||||0.77|TWO_SIDED|95.0|0.44|2.97||False Discovery Rate q-value \> 0.99|Regression, Logistic|||Compare the 4 arms on the rate of actual suicide attempts in a 2x2 factorial design. Main effect of BRITE.||2.97|0.44|0.77
72449723|NCT03825588|144417816|SUPERIORITY||Hazard Ratio (HR)|0.9||||0.74|TWO_SIDED|95.0|0.48|1.69||False Discovery Rate q-value \> 0.99|Regression, Cox|||Compare participants receiving ASAP (ASAP+TAU and ASAP+BRITE+TAU) to those who do not (BRITE+TAU and TAU) on time to actual suicide attempt||1.69|0.48|0.74
72449724|NCT03825588|144417816|SUPERIORITY||Hazard Ratio (HR)|0.78||||0.45|TWO_SIDED|95.0|0.42|1.48||False Discovery Rate q-vale \> 0.99|Regression, Cox|||Compare participants receiving BRITE (BRITE+TAU and ASAP+BRITE+TAU) to those who do not (ASAP+TAU and TAU) on the time to actual suicide attempt||1.48|0.42|0.45
72498842|NCT04533711|144527933|SUPERIORITY||Mean Difference (Final Values)|-2.25||||0.8041|TWO_SIDED|95.0|-20.0|15.49|||Mixed Models Analysis|||||15.49|-20.0|0.8041
72498843|NCT04533711|144527934|SUPERIORITY||Mean Difference (Final Values)|0.07||||0.9645|TWO_SIDED|95.0|-2.86|2.99|||Mixed Models Analysis|||||2.99|-2.86|0.9645
72498844|NCT04533711|144527935|SUPERIORITY||Mean Difference (Final Values)|-2.68||||0.0989|TWO_SIDED|95.0|-5.85|0.49|||Mixed Models Analysis|||||0.49|-5.85|0.0989
72498845|NCT04533711|144527936|SUPERIORITY||Mean Difference (Final Values)|0.14||||0.7667|TWO_SIDED|95.0|-0.77|1.05|||Mixed Models Analysis|||||1.05|-0.77|0.7667
72498846|NCT04533711|144527937|SUPERIORITY||Mean Difference (Final Values)|-0.87||||0.0894|TWO_SIDED|95.0|-1.87|0.13|||Mixed Models Analysis|||||0.13|-1.87|0.0894
72622429|NCT02514746|144774840|OTHER||Difference (Group A - B)|-1.3|||||TWO_SIDED|95.0|-3.3|3.0||||||Difference at 28 days post booster vaccination||3.0|-3.3|
72622430|NCT02514746|144774841|OTHER||GMT Ratio (Group A/B)|0.7|||||TWO_SIDED|95.0|0.5|1.0||||||Geometric mean titer ratio 7 days after booster dose||1.0|0.5|
72622431|NCT02514746|144774841|OTHER||GMT Ratio (Group A/B)|0.7|||||TWO_SIDED|95.0|0.6|0.9||||||Geometric mean titer ratio 28 days after booster dose||0.9|0.6|
72449725|NCT03825588|144417816|SUPERIORITY||Hazard Ratio (HR)|0.47||||0.25|TWO_SIDED|95.0|0.13|1.72||False Discovery Rate q-value \> 0.99|Regression, Cox|||Compare the 4 arms on time to actual suicide attempt in a 2x2 factorial design. Interaction effect of ASAP and BRITE||1.72|0.13|0.25
72449726|NCT03825588|144417816|SUPERIORITY||Hazard Ratio (HR)|1.24||||0.62|TWO_SIDED|95.0|0.54|2.87||False Discovery Rate q-value \> 0.99|Regression, Cox|||Compare the 4 arms on time to actual suicide attempt in a 2x2 factorial design. Main effect of ASAP.||2.87|0.54|0.62
72449727|NCT03825588|144417816|SUPERIORITY||Hazard Ratio (HR)|1.1||||0.83|TWO_SIDED|95.0|0.47|2.59||False Discovery Rate q-value \> 0.99|Regression, Cox|||Compare the 4 arms on time to actual suicide attempt in a 2x2 factorial design. Main effect of BRITE.||2.59|0.47|0.83
72449728|NCT03825588|144417817|SUPERIORITY|||||||0.19||||||False Discovery Rate q-value = 0.72|Chi-squared|||Compare participants receiving ASAP (ASAP+TAU and ASAP+BRITE+TAU) to those who do not (BRITE+TAU and TAU) on the rate of suicidal events|We used standard univariate statistics to compare partici- pants' baseline sociodemographics and clinical characteris- tics by arm \[(ASAP vs No ASAP where comparison is 6 www.jaacap.org (ASAP+TAU) and (ASAP+BRITE+TAU) vs (TAU alone) and (BRITE+TAU); and BRITE vs No BRITE where comparison is (ASAP+BRITE+TAU) and (BRITE+TAU) vs (ASAP+TAU) and (TAU Alone)\], site, retention, pre- post-COVID and recruitment venue. We then tested for equality of the 2 cells (ASAP vs no ASAP, BRITE vs no BRITE) or 4 cells (ASAP+BRITE+TAU vs BRITE +TAU vs ASAP+TAU vs TAU Alone) without covariates on the rates of and time to suicidal behavior using the appropriate (t or F, c2, Kaplan-Meier, Cox models) test statistics. We then used mixed-effects regression models with arm (2 and 4 cells), time, and their interaction for continuous data. Presented percentages are based on all observed data.|||0.19
72449729|NCT03825588|144417817|SUPERIORITY|||||||0.89|TWO_SIDED|95.0||||False Discovery Rate q-value \> 0.99|Chi-squared|||Compare participants receiving BRITE (BRITE+TAU and ASAP+BRITE+TAU) to those who do not (ASAP+TAU and TAU) on the rate of suicidal events||||0.89
72449730|NCT03825588|144417817|SUPERIORITY||Odds Ratio (OR)|0.35||||0.08|TWO_SIDED|95.0|0.11|1.1||False Discovery Rate q-value = 0.72|Regression, Logistic|||Compare participants the 4 arms on the rate of suicidal events in a 2x2 factorial design. Interaction effect of ASAP and BRITE.||1.10|0.11|0.08
72449731|NCT03825588|144417817|SUPERIORITY||Odds Ratio (OR)|1.14||||0.74|TWO_SIDED|95.0|0.51|2.55||False Discovery Rate q \> 0.99|Regression, Logistic|||Compare the 4 arms on time to actual suicide attempt in a 2x2 factorial design. Main effect of ASAP.||2.55|0.51|0.74
72370255|NCT03001817|144251014|SUPERIORITY|||||||0.0509|||||||Hodges-Lehmann method|||||||0.0509
72449732|NCT03825588|144417817|SUPERIORITY||Odds Ratio (OR)|1.69||||0.19|TWO_SIDED|95.0|0.77|3.69||False Discovery Rate q=0.72|Regression, Logistic|||Compare the 4 arms on time to actual suicide attempt in a 2x2 factorial design. Main effect of BRITE.||3.69|0.77|0.19
72449733|NCT06149338|144417823|SUPERIORITY|||||||0.0002||||||Threshold for statistical significance: p \< 0.05|Chi-squared|||||||0.0002
72449734|NCT06149338|144417823|SUPERIORITY||||||<|0.05|||||||Fisher Exact|||||||<0.05
72449735|NCT06149338|144417824|SUPERIORITY||||||<|0.0001||||||Threshold for statistical significance: p \< 0.05|Kruskal-Wallis|||||||< 0.0001
72370256|NCT03001817|144251015|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<.0001
72370257|NCT03001817|144251016|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<0.0001
72449736|NCT06149338|144417825|SUPERIORITY|||||||0.0041||||||Threshold for statistical significance: p \< 0.05|Chi-squared|||||||0.0041
72449737|NCT06149338|144417825|SUPERIORITY||||||<|0.05|||||||Fisher Exact|||||||<0.05
72449738|NCT06149338|144417826|SUPERIORITY|||||||0.7895||||||Threshold for statistical significance: p \< 0.05|Kruskal-Wallis|||||||0.7895
72449739|NCT03916276|144417840|OTHER|We hypothesized negligible between condition differences, although within each condition, we hypothesized that each treatment would produce a greater proportion of people decreasing their dose relative to those increasing their dose during treatment.|||||>|0.05|||||||Chi-squared|||||||>.05
72449740|NCT03916276|144417841|OTHER|We hypothesized negligible between condition differences, although within each condition, we hypothesized that each treatment would produce medium effect size improvements.|||||>|0.05|||||||ANOVA|||||||>.05
72449741|NCT03916276|144417842|OTHER|We hypothesized negligible between condition differences, although within each condition, we hypothesized that each treatment would produce medium effect size improvements.|||||>|0.05|||||||ANOVA|||||||>.05
72449742|NCT03916276|144417843|OTHER|We hypothesized negligible between condition differences, although within each condition, we hypothesized that each treatment would produce medium effect size improvements.|||||>|0.05|||||||ANOVA|||||||>.05
72449743|NCT03916276|144417844|OTHER|We hypothesized negligible between condition differences, although within each condition, we hypothesized that each treatment would produce medium effect size improvements.|||||>|0.05|||||||ANOVA|||||||>.05
72449744|NCT03916276|144417845|OTHER|We hypothesized negligible between condition differences, although within each condition, we hypothesized that each treatment would produce medium effect size improvements.|||||>|0.05|||||||ANOVA|||||||>.05
72449745|NCT03916276|144417846|OTHER|We hypothesized negligible between condition differences, although within each condition, we hypothesized that each treatment would produce medium effect size improvements.|||||>|0.05|||||||ANOVA|||||||>.05
72449746|NCT03916276|144417847|OTHER|We hypothesized negligible between condition differences, although within each condition, we hypothesized that each treatment would produce medium effect size improvements.|||||>|0.05|||||||ANOVA|||||||>.05
72449747|NCT03916276|144417848|OTHER|We hypothesized negligible between condition differences, although within each condition, we hypothesized that each treatment would produce medium effect size improvements.|||||>|0.05|||||||ANOVA|||||||>.05
72449748|NCT03916276|144417849|OTHER|We hypothesized negligible between condition differences, although within each condition, we hypothesized that each treatment would produce medium effect size improvements.|||||<|0.05|||||||ANOVA|||||||<.05
72449749|NCT03916276|144417850|OTHER|We hypothesized negligible between condition differences, although within each condition, we hypothesized that each treatment would produce medium effect size improvements|||||>|0.05|||||||ANOVA|||||||>.05
72449750|NCT03916276|144417851|OTHER|We hypothesized negligible between condition differences, although within each condition, we hypothesized that each treatment would produce medium effect size improvements|||||>|0.05|||||||ANOVA|||||||>.05
72449751|NCT03916276|144417852|OTHER|We hypothesized negligible between condition differences, although within each condition, we hypothesized that each treatment would produce medium effect size improvements.|||||>|0.05|||||||ANOVA|||||||>.05
72622432|NCT02514746|144774842|OTHER||Difference (Group A - B)|-2.9|||||TWO_SIDED|95.0|-8.0|4.5||||||Difference at 7 days post booster vaccination||4.5|-8.0|
72449752|NCT03916276|144417853|OTHER|We hypothesized negligible between condition differences, although within each condition, we hypothesized that each treatment would produce medium effect size improvements.|||||>|0.05|||||||ANOVA|||||||>.05
72449753|NCT03916276|144417854|OTHER|We hypothesized negligible between condition differences, although within each condition, we hypothesized that each treatment would produce medium effect size improvements.|||||>|0.05|||||||ANOVA|||||||>.05
72449754|NCT03916276|144417855|OTHER|We hypothesized negligible between condition differences, although within each condition, we hypothesized that each treatment would produce medium effect size improvements.|||||>|0.05|||||||ANOVA|||||||>.05
72449755|NCT03916276|144417856|OTHER|We hypothesized negligible between condition differences, although within each condition, we hypothesized that each treatment would produce medium effect size improvements.|||||>|0.05|||||||ANOVA|||||||>.05
72449756|NCT04778397|144417867|SUPERIORITY||Stratified Hazard Ratio|1.132||||0.507|TWO_SIDED|95.0|0.783|1.637|||Stratified log-rank test|P-value from stratified log-rank test.|||Hazard ratio and 95% CIs were calculated using the Cox proportional hazards model, adjusted for randomization stratification factors (appropriateness for non-intensive therapy vs intensive therapy, age (\< 75 years, \>=75 years), geographic region (US sites, outside the US sites)).|1.637|0.783|0.5070
72561885|NCT04974580|144654627|SUPERIORITY||Odds Ratio (OR)|1.3||||0.14|TWO_SIDED|95.0|0.91|1.84||A priori threshold was 0.10|Regression, Logistic||Reported OR is NRT receipt vs. not, so values \>1 indicate higher odds of abstinence among those receiving NRT.|Comparison of NRT vs. no-NRT in model adjusted for receipt of digital component||1.84|0.91|0.14
72449757|NCT04778397|144417868|SUPERIORITY||Stratified Hazard Ratio|1.183||||0.3237|TWO_SIDED|95.0|0.845|1.654|||Stratified Log-rank test|P-value from stratified log-rank test.|||Hazard ratio and 95% CIs were calculated using the Cox proportional hazards model, adjusted for randomization stratification factors (appropriateness for non-intensive therapy vs intensive therapy, age (\< 75 years, \>=75 years), geographic region (US sites, outside the US sites)).|1.654|0.845|0.3237
72449758|NCT04778397|144417869|SUPERIORITY||Stratified Hazard Ratio|1.389||||0.0661|TWO_SIDED|95.0|1.043|1.848|||Stratified Log-rank test|P-value for comparing the event free survival functions from the two treatment groups was from stratified log-rank test, adjusted for randomization.|||Hazard ratio and 95% CIs were calculated using the Cox proportional hazards model, adjusted for randomization stratification factors: therapy appropriateness, age (\< 75 years, \>=75 years), geographic region (US sites, outside the US sites).|1.848|1.043|0.0661
72449759|NCT04778397|144417870|SUPERIORITY||Stratified Odds Ratio|0.25|||||TWO_SIDED|95.0|0.123|0.506|||||||Odds ratio and 2-sided 95% CI were calculated from stratum-adjusted Mantel-Haenszel estimates adjusted for randomization stratification factors (appropriateness for non-intensive therapy versus intensive therapy, age (\< 75 years, \>=75 years), geographic region (US sites, outside US sites)).|0.506|0.123|
72449760|NCT04778397|144417871|SUPERIORITY||Stratified Odds Ratio|0.072|||||TWO_SIDED|95.0|0.009|0.559|||||||Odds ratio and 2-sided 95% CI were calculated from stratum-adjusted Mantel-Haenszel estimates adjusted for randomization stratification factors (appropriateness for non-intensive therapy versus intensive therapy, age (\< 75 years, \>=75 years), geographic region (US sites, outside US sites)).|0.559|0.009|
72449761|NCT04778397|144417872|SUPERIORITY||Stratified Odds Ratio|0.215|||||TWO_SIDED|95.0|0.108|0.428|||||||Odds ratio and 2-sided 95% CI were calculated from stratum-adjusted Mantel-Haenszel estimates adjusted for randomization stratification factors (appropriateness for non-intensive therapy versus intensive therapy, age (\< 75 years, \>=75 years), geographic region (US sites, outside US sites)).|0.428|0.108|
72449762|NCT02668692|144417900|SUPERIORITY||Odds Ratio (OR)|1.96|||=|0.68|TWO_SIDED|95.0|0.35|10.95|||Fisher Exact|||Statistical analysis of the FAS.||10.95|0.35|=0.68
72449763|NCT02668692|144417900|SUPERIORITY||Odds Ratio (OR)|1.92|||=|0.68|TWO_SIDED|95.0|0.34|10.72||Treatment comparison by Fisher's exact test.|Fisher Exact||Odds of 'overall improvement' in LEO 80185 gel group relative to Dovobet® ointment group.|Statistical analysis of the PPAS.||10.72|0.34|=0.68
72449764|NCT02668692|144417901|SUPERIORITY||Odds Ratio (OR)|0.28|||=|0.009|TWO_SIDED|95.0|0.11|0.74|||Fisher Exact|||Statistical analysis for the FAS.||0.74|0.11|=0.009
72449765|NCT02668692|144417901|SUPERIORITY||Odds Ratio (OR)|0.22|||=|0.003|TWO_SIDED|95.0|0.08|0.63||Treatment comparison by Fisher's exact test.|Fisher Exact||Odds of 'overall improvement' in LEO 80185 gel group relative to Dovobet® ointment group.|Statistical analysis of the PPAS.||0.63|0.08|=0.003
72449766|NCT01627574|144417914|SUPERIORITY||Risk Ratio, log|0.281|STANDARD_ERROR_OF_MEAN|0.07|>|0.05|TWO_SIDED|95.0|0.056|1.42|||Chi-squared, Corrected|||||1.42|.056|>.05
72370258|NCT03001817|144251017|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<.0001
72449767|NCT03308877|144417923|OTHER|||||||0.07||||||Covariates include education \& percent days abstinent at baseline.|Regression, Linear|||Hypothesis 1: Affective psychopathy scores will moderate response to a BMI such that individuals with lower scores will benefit relative to controls, but individuals with higher psychopathy scores will not benefit from the intervention in terms of percent days abstinent.||||.07
72449768|NCT03308877|144417923|OTHER|||||||0.02|||||||Regression, Linear|||Sensitivity analysis: proximal follow-up (3 months following BMI or SC)||||.02
72449769|NCT03308877|144417923|OTHER||B|0.063|||<|0.01|TWO_SIDED|95.0|0.007|0.156|||Regression, Linear|bias corrected bootstrap||Increased readiness to change will be associated with decreased substance use.||.156|.007|<.01
72449770|NCT03308877|144417924|OTHER|||||||0.74|||||||Regression, Linear|||||||.74
72449771|NCT03308877|144417925|OTHER|||||||0.88|||||||Regression, Logistic|||||||.88
72449772|NCT05233800|144417926|SUPERIORITY||Mean Difference (Net)|5.83|||<|0.05|TWO_SIDED|95.0|3.84|7.81|||Mixed Models Analysis|||||7.81|3.84|<0.05
72449773|NCT03643744|144417933|SUPERIORITY|||||||0.53|||||||ANOVA|||||||0.530
72449774|NCT03643744|144417933|SUPERIORITY|||||||0.727|||||||ANOVA|||||||0.727
72561886|NCT04974580|144654627|SUPERIORITY||Odds Ratio (OR)|1.04||||0.84|TWO_SIDED|95.0|0.73|1.47||A priori threshold was 0.10|Regression, Logistic||Reported OR is Digital receipt vs. not, so values \>1 indicate higher odds of abstinence among those receiving the Digital component.|Comparison of Digital vs. no Digital in model adjusted for receipt of NRT component||1.47|0.73|0.84
72370259|NCT03001817|144251018|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<.0001
72622433|NCT02514746|144774842|OTHER||Difference (Group A - B)|-1.8|||||TWO_SIDED|95.0|-4.4|3.0||||||Difference at 28 days post booster vaccination||3.0|-4.4|
72449775|NCT03643744|144417934|SUPERIORITY||||||>|0.05|||||||t-test, 2 sided|||||||>0.05
72370260|NCT03001817|144251019|SUPERIORITY|||||||0.0647|||||||Hodges-Lehmann method|||||||0.0647
72449776|NCT04707469|144417995|SUPERIORITY|Change from baseline was analyzed using an ANCOVA model with treatment, strata and region as categorical fixed effects and baseline value as covariate for each of the 1000 imputed complete datasets,and pooled by Rubin's rule to draw inference.|Treatment difference|-0.27||||0.0006|TWO_SIDED|95.0|-0.42|-0.12||Unadjusted two-sided p-value for test of no difference.|ANCOVA|||Treatment policy estimand||-0.12|-0.42|0.0006
72449777|NCT04707469|144417995|SUPERIORITY|Change from baseline was analyzed using an ANCOVA model with treatment, strata and region as categorical fixed effects and baseline value as covariate for each of the 1000 imputed complete datasets,and pooled by Rubin's rule to draw inference.|Treatment difference|-0.53|||<|0.0001|TWO_SIDED|95.0|-0.68|-0.38||Unadjusted two-sided p-value for test of no difference.|ANCOVA|||Treatment policy estimand||-0.38|-0.68|<.0001
72449778|NCT04487860|144418034|SUPERIORITY|||||||0.7905|||||||ANCOVA|||||||0.7905
72449779|NCT04487860|144418034|SUPERIORITY|||||||0.7372|||||||ANCOVA|||||||0.7372
72449780|NCT04487860|144418034|SUPERIORITY|||||||0.2989|||||||ANCOVA|||||||0.2989
72449781|NCT04487860|144418034|SUPERIORITY|||||||0.3328|||||||ANCOVA|||||||0.3328
72449782|NCT04487860|144418035|SUPERIORITY|||||||0.8989|||||||ANCOVA|||||||0.8989
72449783|NCT04487860|144418035|SUPERIORITY|||||||0.6768|||||||ANCOVA|||||||0.6768
72449784|NCT04487860|144418035|SUPERIORITY|||||||0.8209|||||||ANCOVA|||||||0.8209
72449785|NCT04487860|144418035|SUPERIORITY|||||||0.3106|||||||ANCOVA|||||||0.3106
72449786|NCT04487860|144418036|SUPERIORITY|||||||0.8593|||||||ANCOVA|||||||0.8593
72449787|NCT04487860|144418036|SUPERIORITY|||||||0.9594|||||||ANCOVA|||||||0.9594
72449788|NCT04487860|144418036|SUPERIORITY|||||||0.9041|||||||ANCOVA|||||||0.9041
72449789|NCT04487860|144418036|SUPERIORITY|||||||0.7147|||||||ANCOVA|||||||0.7147
72449790|NCT04359654|144418043|SUPERIORITY|||||||0.01|||||||Mixed Models Analysis|||||||0.01
72449791|NCT04359654|144418044|SUPERIORITY|||||||0.03|||||||Mixed Models Analysis|||||||0.03
72449792|NCT04359654|144418046|SUPERIORITY|||||||0.004|||||||Mixed Models Analysis|||||||0.004
72449793|NCT04359654|144418047|SUPERIORITY|||||||0.021|||||||Mixed Models Analysis|||The reported LS means are antilogs of the LS means estimated on the log scale.||||0.021
72449794|NCT03625115|144418172|EQUIVALENCE|A two-tailed t-test was done to compare the mean Bayley cognitive scores between the groups.||||||0.3|||||||t-test, 2 sided|||||||0.30
72449795|NCT03625115|144418173|SUPERIORITY||Pearson chi square (1)|8.51||||0.004|TWO_SIDED||||||Chi-squared|||Chi-square test of independence to determine if there was a significant difference between intervention arms for those who completed a multidisciplinary evaluation (referral completed).||||.004
72449796|NCT03625115|144418174|SUPERIORITY||Pearson chi square (1)|0.05||||0.82|TWO_SIDED||||||Chi-squared|||Chi-square test of independence to determine if there was a significant difference between intervention arms for those who began early intervention services.||||.82
72449797|NCT03625115|144418175|EQUIVALENCE|A two-tailed t-test was done to compare the mean Bayley language scores between the groups.||||||0.69|||||||t-test, 2 sided|||||||0.69
72449798|NCT03625115|144418177|EQUIVALENCE|two tailed t-test to compare the means of factor 1 between groups||||||0.858|||||||t-test, 2 sided|||Analysis of factor 1 items from the parent engagement questionnaire. Factor 1 (Buy-in) I am open to getting EI for my child. EI can help my child. EI can teach me new ways to help my child.||||.858
72449799|NCT03625115|144418177|EQUIVALENCE|two tailed t-test to compare the means of factor 2 between groups||||||0.995|||||||t-test, 2 sided|||"Analysis of factor 2 items from the parent engagement questionnaire.~Factor 2 (early intervention consequences):~EI could have negative consequences for my child. Getting EI for my child reflects negatively on me as a parent."||||.995
72370261|NCT03001817|144251020|SUPERIORITY|||||||0.0007|||||||Hodges-Lehmann method|||||||0.0007
72449800|NCT03625115|144418177|EQUIVALENCE|two tailed t-test to compare the means of factor 3 between groups||||||0.049|||||||t-test, 2 sided|||"Analysis of factor 3 items from the parent engagement questionnaire.~Factor 3 (Knowledge/Self-Efficacy):~I know how to get EI for my child. I understand how the EI process works. If I have questions about EI, I know who to call. 12. I know my child's rights to EI under the law."||||.049
72449801|NCT03625115|144418178|SUPERIORITY||Odds Ratio (OR)|1.87||||0.02|TWO_SIDED|95.0|1.09|3.21|||Regression, Logistic|||A logistic regression was run to determine if the intervention arm, adjusted for child sex, income, maternal education, and primary care site, was associated with the completion of early intervention referrals for families with an adverse childhood experience survey score of greater than 2.||3.21|1.09|.02
72449802|NCT01236781|144418210|EQUIVALENCE|no margin is assumed.||||||0.46||||||1 degree of freedom;|McNemar|Exact test||"To account for the paired nature of the design, McNemar's test will be used to compare the call-back rates.~H0: assumes no difference between the tests (modalities)"||||0.46
72449803|NCT01236781|144418213|EQUIVALENCE|no equivalence margin||||||0.2188||||||Due to the paired nature of the data an exact McNemar's Test is used|McNemar|Exact test||H0: no difference between the 2 modalities||||0.2188
72449804|NCT04028284|144418217|OTHER|Two-sided inferential test||||||0.02||||||Adjusted for multiple comparisons using the Holm-Bonferroni correction. The a priori threshold for statistical significance was P \< 0.05 for the primary outcome.|t-test, 2 sided|||||||0.02
72449805|NCT04028284|144418218|OTHER|Inferential two-sided test||||||0.31|||||||t-test, 2 sided|||||||0.31
72449806|NCT04028284|144418219|OTHER|Inferential two-sided test||||||0.01||||||Adjusted for multiple comparisons using the Holm-Bonferroni correction.|t-test, 2 sided|||||||0.01
72449807|NCT04028284|144418220|OTHER|Inferential two-sided test||||||0.03||||||Adjusted for multiple comparisons using the Holm-Bonferroni correction.|t-test, 2 sided|||||||0.03
72449808|NCT04028284|144418221|OTHER|Inferential two-sided test||||||0.56|||||||t-test, 2 sided|||||||0.56
72449809|NCT04028284|144418222|OTHER|Inferential two-sided test||||||0.78|||||||t-test, 2 sided|||||||0.78
72449810|NCT04028284|144418223|OTHER|Inferential two-sided test||||||0.24|||||||Fisher Exact|||||||0.24
72449811|NCT03314688|144418229|SUPERIORITY|||||||0.69|||||||t-test, 2 sided|||||||0.69
72449812|NCT03314688|144418230|SUPERIORITY|||||||0.33|||||||Chi-squared|||Comparison of Q1: In the past month, how often did you take your aromatase inhibitor (AI)/tamoxifen pills as the doctor prescribed? = 'All the time'||||0.33
72449813|NCT03314688|144418230|SUPERIORITY|||||||0.44|||||||Chi-squared|||Comparison of Q2: In the past month, how often did you forget to take one or more of your aromatase inhibitor (AI)/tamoxifen pills? = 'Never'||||0.44
72370262|NCT03001817|144251021|SUPERIORITY|||||||0.1399|||||||Hodges-Lehmann method|||||||0.1399
72370263|NCT03001817|144251022|SUPERIORITY|||||||0.0122|||||||Hodges-Lehmann method|||||||0.0122
72370264|NCT03001817|144251023|SUPERIORITY|||||||0.0994|||||||Hodges-Lehmann method|||||||0.0994
72370265|NCT03001817|144251024|SUPERIORITY|||||||0.0904|||||||Hodges-Lehmann method|||||||0.0904
72370266|NCT03001817|144251025|SUPERIORITY|||||||0.4346|||||||non-parametric Hodges-Lehmann method|||||||0.4346
72370267|NCT03001817|144251026|SUPERIORITY|||||||0.1474|||||||non-parametric Hodges-Lehmann method|||||||0.1474
72370268|NCT03001817|144251027|SUPERIORITY|||||||0.0054|||||||non-parametric Hodges-Lehmann method|||||||0.0054
72370269|NCT03001817|144251028|SUPERIORITY|||||||0.0002|||||||Hodges-Lehmann method|||||||0.0002
72370270|NCT03001817|144251029|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<.0001
72390908|NCT00622284|144289424|NON_INFERIORITY_OR_EQUIVALENCE|The null hypothesis of non-inferiority is rejected if the upper bound of the two-sided 97.5% confidence interval is less than 0.35%. Superiority testing was not part of the pre-specified Week 52 confirmatory analysis.|Least Squares Mean Difference|0.22|STANDARD_ERROR_OF_MEAN|0.04||0.0005||97.5|0.13|0.31||Due to multiple testing of the primary endpoints at weeks 52 and 104 a Bonferroni correction was applied and 97.5% confidence intervals produced. This 1-sided p-value for non-inferiority should be compared to the 1-sided threshold of 0.0125.|ANCOVA|||Linagliptin versus Glimepiride||0.31|0.13|0.0005
72370271|NCT03001817|144251030|SUPERIORITY|||||||0.0118|||||||Hodges-Lehmann method|||||||0.0118
72370272|NCT03001817|144251031|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<.0001
72370273|NCT03001817|144251032|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<.0001
72370274|NCT03001817|144251033|SUPERIORITY|||||||0.2049|||||||Hodges-Lehmann method|||||||0.2049
72370275|NCT03001817|144251034|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<0.0001
72370276|NCT03001817|144251035|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<0.0001
72370277|NCT03001817|144251036|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<0.0001
72370278|NCT03001817|144251037|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<0.0001
72390909|NCT00622284|144289425|NON_INFERIORITY_OR_EQUIVALENCE|The null hypothesis of non-inferiority is rejected if the upper bound of the two-sided 97.5% confidence interval is less than 0.35%. However, superiority testing is only applicable if the Linagliptin decrease is greater than that in Glimepiride.|Least Squares Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|0.05||0.0004||97.5|0.09|0.3||This 1-sided p-value should be compared to the 1-sided threshold of 0.0125 for non-inferiority. Due to the pre-specified hierarchial approach, further confirmatory analysis on the Week24 endpoints is only applicable if superiority is already met.|ANCOVA|||Linagliptin versus Glimepiride||0.30|0.09|0.0004
72370279|NCT03001817|144251038|SUPERIORITY|||||||0.9117|||||||Hodges-Lehmann method|||||||0.9117
72370280|NCT03001817|144251039|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<0.0001
72370281|NCT00035932|144251098|NON_INFERIORITY_OR_EQUIVALENCE|The time-averaged difference (TAD) in the reduction of log10 HIV RNA levels from baseline through Week 24 was compared pairwise for each atazanavir regimen to the lopinavir/RTV regimen, and assessed using a two-sided 97.5% confidence interval. The primary efficacy analysis was to declare two treatment regimens similar if the upper limit of this 97.5% confidence interval for the difference (atazanavir-lopinavir/RTV) was less than 0.5 log10.|Time-Averaged Difference|0.14|||||TWO_SIDED|97.5|-0.09|0.37||||||||0.37|-0.09|
72370282|NCT00035932|144251098|NON_INFERIORITY_OR_EQUIVALENCE|The time-averaged difference (TAD) in the reduction of log10 HIV RNA levels from baseline through Week 24 was compared pairwise for each atazanavir regimen to the lopinavir/RTV regimen, and assessed using a two-sided 97.5% confidence interval. The primary efficacy analysis was to declare two treatment regimens similar if the upper limit of this 97.5% confidence interval for the difference (atazanavir-lopinavir/RTV) was less than 0.5 log10.|Time-Averaged Difference|0.31|||||TWO_SIDED|97.5|0.07|0.55||||||||0.55|0.07|
72370283|NCT00035932|144251099|SUPERIORITY_OR_OTHER||Treatment Difference|0.13|||||TWO_SIDED|95.0|-0.04|0.3||||||||0.30|-0.04|
72370284|NCT00035932|144251099|SUPERIORITY_OR_OTHER||Treatment Difference|0.17|||||TWO_SIDED|95.0|-0.01|0.35||||||||0.35|-0.01|
72370285|NCT00035932|144251102|SUPERIORITY_OR_OTHER||Time-Averaged Difference|0.13|||||TWO_SIDED|97.5|-0.12|0.39||||||||0.39|-0.12|
72390910|NCT00622284|144289426|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-2.5|STANDARD_ERROR_OF_MEAN|0.18|<|0.0001||97.5|-2.91|-2.09||This Week52 key secondary endpoint was only to be tested (2-sided threshold of 0.025 to allow for multiple testing within a visit) if the Week52 primary hypothesis was rejected.|ANCOVA|||Linagliptin versus Glimepiride||-2.09|-2.91|<0.0001
72390911|NCT00622284|144289427|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-2.68|STANDARD_ERROR_OF_MEAN|0.22|<|0.0001||97.5|-3.17|-2.19||Due to testing of multiple endpoints within a visit a sequential testing strategy (at 2-sided threshold of 0.025) was applied to the key secondary endpoints.|ANCOVA|||Linagliptin versus Glimepiride||-2.19|-3.17|<0.0001
72390912|NCT00622284|144289428|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||This key secondary endpoint was only to be tested (comparing to a 2-sided threshold of 0.025) if the Week52 body weight change from baseline was confirmatory.|Cochran-Mantel-Haenszel|||Linagliptin versus Glimepiride||||<0.0001
72390913|NCT00622284|144289429|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Due to testing of multiple endpoints within a visit a sequential testing strategy (at 2-sided threshold of 0.025) was applied to the key secondary endpoints.|Cochran-Mantel-Haenszel|||Linagliptin versus Glimepiride||||<0.0001
72390914|NCT00622284|144289430|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|6.84|STANDARD_ERROR_OF_MEAN|1.7|<|0.0001||95.0|3.51|10.16|||ANCOVA|||Linagliptin versus Glimepiride||10.16|3.51|<0.0001
72390915|NCT00622284|144289431|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|6.38|STANDARD_ERROR_OF_MEAN|1.97||0.0012||95.0|2.51|10.25|||ANCOVA|||Linagliptin versus Glimepiride||10.25|2.51|0.0012
72390916|NCT00622284|144289432|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.625||||0.0004||95.0|0.482|0.811|||Regression, Logistic|The odds ratio is treatment adjusted for baseline HbA1c and the number of previous anti-diabetic medications.||Linagliptin versus Glimepiride||0.811|0.482|0.0004
72390917|NCT00622284|144289433|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.654||||0.003||95.0|0.494|0.866|||Regression, Logistic|The odds ratio is treatment adjusted for baseline HbA1c and the number of previous anti-diabetic medications.||Linagliptin versus Glimepiride||0.866|0.494|0.0030
72449814|NCT03314688|144418230|SUPERIORITY|||||||0.29|||||||Chi-squared|||Comparison of Q3: In the past month, how often did you decide to skip one or more of your aromatase inhibitor (AI)/tamoxifen pills? = 'Never'||||0.29
72370286|NCT00035932|144251102|SUPERIORITY_OR_OTHER||Time-Averaged Distance|0.33|||||TWO_SIDED|97.5|0.07|0.6||||||||0.60|0.07|
72370287|NCT00035932|144251103|SUPERIORITY_OR_OTHER||Difference estimate|-0.5|||||TWO_SIDED|95.0|-13.3|12.3|||||ATV 300/RTV - LPV/RTV|Randomized participants||12.3|-13.3|
72370288|NCT00035932|144251104|SUPERIORITY_OR_OTHER||Difference Estimate|3.6|||||TWO_SIDED|95.0|-7.0|14.1||||||||14.1|-7.0|
72370289|NCT00035932|144251104|SUPERIORITY_OR_OTHER||Difference Estimate|-11.3|||||TWO_SIDED|95.0|-22.9|0.4||||||||0.4|-22.9|
72370290|NCT00035932|144251106|SUPERIORITY_OR_OTHER||Difference Estimate|-5.0|||||TWO_SIDED|95.0|-16.9|7.0||||||||7.0|-16.9|
72370291|NCT00035932|144251106|SUPERIORITY_OR_OTHER||Difference Estimate|-16.1|||||TWO_SIDED|95.0|-28.5|-3.7||||||||-3.7|-28.5|
72370292|NCT00035932|144251108|SUPERIORITY_OR_OTHER||Difference Estimate|0.4|||||TWO_SIDED|95.0|-12.5|13.2|||||ATV 300/RTV - LPV/RTV|||13.2|-12.5|
72370293|NCT00035932|144251109|SUPERIORITY_OR_OTHER||Difference Estimate|3.2|||||TWO_SIDED|95.0|-9.1|15.4||||||||15.4|-9.1|
72370294|NCT00035932|144251109|SUPERIORITY_OR_OTHER||Difference Estimate|-16.7|||||TWO_SIDED|95.0|-29.4|-4.0||||||||-4.0|-29.4|
72370295|NCT00035932|144251110|SUPERIORITY_OR_OTHER||Difference Estimate|-1.1|||||TWO_SIDED|95.0|-13.7|11.4||||||||11.4|-13.7|
72370296|NCT00035932|144251110|SUPERIORITY_OR_OTHER||Difference Estimate|-17.9|||||TWO_SIDED|95.0|-30.6|-5.3||||||||-5.3|-30.6|
72370297|NCT00035932|144251111|SUPERIORITY_OR_OTHER||Difference Estimate|-2.4|||||TWO_SIDED|95.0|-15.0|10.3|||Chi-squared, Corrected||ATV 300/RTV - LPV/RTV|||10.3|-15.0|
72370298|NCT00035932|144251112|SUPERIORITY_OR_OTHER||Difference Estimate|-2.3|||||TWO_SIDED|95.0|-14.6|10.0||||||||10.0|-14.6|
72370299|NCT00035932|144251112|SUPERIORITY_OR_OTHER||Difference Estimate|-18.9|||||TWO_SIDED|95.0|-30.7|-7.1||||||||-7.1|-30.7|
72370300|NCT00035932|144251113|SUPERIORITY_OR_OTHER||Difference Estimate|-6.4|||||TWO_SIDED|95.0|-18.7|5.8||||||||5.8|-18.7|
72370301|NCT00035932|144251113|SUPERIORITY_OR_OTHER||Difference Estimate|-17.9|||||TWO_SIDED|95.0|-29.9|-5.9||||||||-5.9|-29.9|
72370302|NCT00035932|144251115|SUPERIORITY_OR_OTHER||Time-Averaged Difference|-18.4|||||TWO_SIDED|97.5|-44.3|7.5||||||||7.5|-44.3|
72370303|NCT00035932|144251115|SUPERIORITY_OR_OTHER||Time-Averaged Difference|-44.9|||||TWO_SIDED|97.5|-74.5|-15.3||||||||-15.3|-74.5|
72370304|NCT00035932|144251116|SUPERIORITY_OR_OTHER||Time-Averaged Difference|-17.5|||||TWO_SIDED|97.5|-45.6|10.6||||||||10.6|-45.6|
72370305|NCT00035932|144251116|SUPERIORITY_OR_OTHER||Time-Averaged Difference|-47.6|||||TWO_SIDED|97.5|-79.2|-16.1||||||||-16.1|-79.2|
72370306|NCT00035932|144251118|SUPERIORITY_OR_OTHER||||||<|0.05||95.0||||P-value was based on a t-distribution.|t-test, 1 sided|||Correlation between IQ (\<10; \>=10) of ATV 300 mg / RTV and HIV RNA||||<0.05
72370307|NCT00035932|144251118|SUPERIORITY_OR_OTHER||||||<|0.05||95.0||||P-value was based on a t-distribution.|t-test, 1 sided|||Correlation between number of PI Mutations at baseline (\<4; \>=4) of ATV 400 mg / SQV and HIV RNA||||<0.05
72370308|NCT00035932|144251120|SUPERIORITY_OR_OTHER||||||<|0.05||95.0||||P-value was based on a t-distribution.|t-test, 1 sided|||Correlation between ATV Cmin of ATV 300 mg / RTV and CD4 Cell Count||||<0.05
72370309|NCT00035932|144251120|SUPERIORITY_OR_OTHER||||||<|0.05||95.0||||P-value was based on a t-distribution.|t-test, 1 sided|||Correlation between IQ (\<10; \>=10) of ATV 300 mg / RTV and CD4 Cell Count||||<0.05
72370310|NCT00035932|144251120|SUPERIORITY_OR_OTHER||||||<|0.05||95.0||||P-value was based on a t-distribution.|t-test, 1 sided|||Correlation between # of PI Mutations at baseline (\<4; \>=4) of ATV 300 mg / RTV and CD4 Cell Count||||<0.05
72370311|NCT00035932|144251122|SUPERIORITY_OR_OTHER||Difference Estimate|-10.9|||||TWO_SIDED|95.0|-15.5|-6.0||||||Total Cholesterol||-6.0|-15.5|
72370312|NCT00035932|144251122|SUPERIORITY_OR_OTHER||Difference Estimate|-12.4|||||TWO_SIDED|95.0|-16.9|-7.6||||||Total Cholesterol||-7.6|-16.9|
72370313|NCT00035932|144251122|SUPERIORITY_OR_OTHER||Difference Estimate|-6.7|||||TWO_SIDED|95.0|-13.6|0.7||||||HDL cholesterol||0.7|-13.6|
72370314|NCT00035932|144251122|SUPERIORITY_OR_OTHER||Difference Estimate|-1.0|||||TWO_SIDED|95.0|-9.3|8.1||||||HDL Cholesterol||8.1|-9.3|
72370315|NCT00035932|144251122|SUPERIORITY_OR_OTHER||Difference Estimate|-6.8|||||TWO_SIDED|95.0|-15.6|3.0||||||Fasting LDL Cholesterol||3.0|-15.6|
72370316|NCT00035932|144251122|SUPERIORITY_OR_OTHER||Difference Estimate|-7.3|||||TWO_SIDED|95.0|-15.5|1.8||||||Fasting LDL Cholesterol||1.8|-15.5|
72370317|NCT00035932|144251122|SUPERIORITY_OR_OTHER||Difference Estimate|-24.9|||||TWO_SIDED|95.0|-35.0|-13.2||||||Fasting Triglycerides||-13.2|-35.0|
72370318|NCT00035932|144251122|SUPERIORITY_OR_OTHER||Difference Estimate|-34.2|||||TWO_SIDED|95.0|-43.4|-23.4||||||Fasting Triglycerides||-23.4|-43.4|
72370319|NCT00035932|144251123|SUPERIORITY_OR_OTHER||Difference Estimate|-12.1|||||TWO_SIDED|95.0|-17.0|-7.2||||||Total Cholesterol||-7.2|-17.0|
72370320|NCT00035932|144251123|SUPERIORITY_OR_OTHER||Difference Estimate|-12.0|||||TWO_SIDED|95.0|-17.4|-6.5||||||Total Cholesterol||-6.5|-17.4|
72370321|NCT00035932|144251123|SUPERIORITY_OR_OTHER||Difference Estimate|-4.4|||||TWO_SIDED|95.0|-12.4|3.5||||||HDL Cholesterol||3.5|-12.4|
72370322|NCT00035932|144251123|SUPERIORITY_OR_OTHER||DIfference Estimate|-0.8|||||TWO_SIDED|95.0|-11.0|9.3||||||HDL Cholesterol||9.3|-11.0|
72370323|NCT00035932|144251123|SUPERIORITY_OR_OTHER||Difference Estimate|-8.9|||||TWO_SIDED|95.0|-19.0|1.2||||||Fasting LDL CHolesterol||1.2|-19.0|
72370324|NCT00035932|144251123|SUPERIORITY_OR_OTHER||Difference Estimate|-7.4|||||TWO_SIDED|95.0|-17.7|3.0||||||Fasting LDL Cholesterol||3.0|-17.7|
72370325|NCT00035932|144251123|SUPERIORITY_OR_OTHER||Difference Estimate|-29.6|||||TWO_SIDED|95.0|-41.6|-17.7||||||Fasting Triglycerides||-17.7|-41.6|
72370326|NCT00035932|144251123|SUPERIORITY_OR_OTHER||Difference Estimate|-38.4|||||TWO_SIDED|95.0|-49.7|-27.1||||||Fasting Triglycerides||-27.1|-49.7|
72370327|NCT00035932|144251124|SUPERIORITY_OR_OTHER||Difference Estimate|-14.4|||||TWO_SIDED|95.0|-20.1|-8.3|||||ATV 300/RTV - LPV/RTV|Observed values, Total Cholesterol||-8.3|-20.1|
72370328|NCT00035932|144251124|SUPERIORITY_OR_OTHER||Difference Estimate|-9.0|||||TWO_SIDED|95.0|-16.1|-1.3|||||ATV 400/SQV - LPV/RTV|observed values, total cholesterol||-1.3|-16.1|
72370329|NCT00035932|144251124|SUPERIORITY_OR_OTHER||Difference Estimate|-11.0|||||TWO_SIDED|95.0|-19.9|-1.2|||||ATV 300/RTV - LPV/RTV|observed values, HDL cholesterol||-1.2|-19.9|
72370330|NCT00035932|144251124|SUPERIORITY_OR_OTHER||Difference Estimate|-4.1|||||TWO_SIDED|95.0|-14.0|7.0|||||ATV 400/SQV - LPV/RTV|Observed values, HDL cholesterol||7.0|-14.0|
72370331|NCT00035932|144251124|SUPERIORITY_OR_OTHER||Difference Estimate|-12.7|||||TWO_SIDED|95.0|-22.3|-1.8|||||ATV 300/RTV - LPV/RTV|observed cases, fasting LDL||-1.8|-22.3|
72449815|NCT03314688|144418231|SUPERIORITY|||||||0.69|||||||Chi-squared|||Comparison of Q1: In the past month, how often did you take your aromatase inhibitor (AI)/tamoxifen pills as the doctor prescribed? = 'All the time'||||0.69
72449816|NCT03314688|144418231|SUPERIORITY|||||||0.91|||||||Chi-squared|||Comparison of Q2: In the past month, how often did you forget to take one or more of your aromatase inhibitor (AI)/tamoxifen pills? = 'Never'||||0.91
72449817|NCT03314688|144418231|SUPERIORITY|||||||0.13|||||||Chi-squared|||Comparison of Q3: In the past month, how often did you decide to skip one or more of your aromatase inhibitor (AI)/tamoxifen pills? = 'Never'||||0.13
72449818|NCT05565820|144418303|SUPERIORITY||difference in proportions|-0.335|STANDARD_ERROR_OF_MEAN|0.149||0.025|TWO_SIDED|||||Alpha: .05|Z-test for difference in proportions|Z: 2.246 Cohen's d: .590|Direction of comparison: Vamousse Day 2 proportion of live lice - Nix Day 2 proportion of live lice|"Null hypothesis: At Day 2 the proportion of lice free subjects in the Vamousse Spray 'n' Go group does not exceed that in the Nix Creme Rinse Lice Treatment group.~The null hypothesis is one-tailed. However, for consistency with the practice of reporting conservative p-values in clinical studies, the two-tailed p-value will be reported."||||.025
72449819|NCT05565820|144418303|SUPERIORITY||Difference in proportions|0.348|STANDARD_ERROR_OF_MEAN|0.141||0.014|TWO_SIDED|||||Alpha: .05.|Z-test for difference in proportions|Z 2.469 Cohen's d .660|Direction of comparison: Vamousse Day 7 proportion live lice free - Nix Day 7 proportion live lice free|"Null hypothesis: At Day 7 the proportion of lice free subjects in the Vamousse Spray 'n' Go group does not exceed that in the Nix Creme Rinse Lice Treatment group.~The null hypothesis is one-tailed. However, for consistency with the practice of reporting conservative p-values in clinical studies, the two-tailed p-value will be reported."||||.014
72449820|NCT05565820|144418303|SUPERIORITY||Difference in proportions|0.283|STANDARD_ERROR_OF_MEAN|0.147||0.054|TWO_SIDED|||||Alpha: .05|Z-test for difference in proportions|Z: 1.920 Cohen's d: .513|Vamousse Day 14 proportion live lice free - Nix Day 14 proportion live lice free|"Null hypothesis: At Day 14 the proportion of lice-free subjects in the Vamousse Spray 'n' Go group does not exceed that in the Nix Creme Rinse Lice Treatment group.~The null hypothesis is one-tailed. However, for consistency with the practice of reporting conservative p-values in clinical studies, the two-tailed p-value will be reported."||||.054
72449821|NCT05565820|144418304|SUPERIORITY|"To check on the effect of the non-normality of the change proportions, the nonparametric Mann-Whitney test was also performed.~The null hypothesis is one-tailed. However, for consistency with the practice of reporting conservative p-values in clinical studies, the two-tailed p-value will be reported."|Mean Difference (Final Values)|0.295|STANDARD_ERROR_OF_MEAN|0.1148||0.02|TWO_SIDED|95.0|0.052|0.537||Alpha = .05 t: 2.567 df (adjusted, see comment below): 16.83 Mann-Whitney Z: 2.830 p(2-tailed) of Mann-Whitney Z: .005 Cohen's d = 1.023|t-test, 2 sided|Degrees of freedom for the t-test were adjusted for inequality of variances between the groups using the Satterthwaite correction: df(adj) = 16.83|Direction of comparison: Vamousse prop. reduction in live lice count from Day O - Nix prop. reduction in live lice count from Day O|"Null hypothesis: At Day 2 the mean proportion of decrease from Day 0 in the number of live lice in the Vamousse group does not exceed that in the Nix group.~The distribution of the Day 0 to Day 2 change proportions deviated significantly from normality by the Shapiro-Wilk test for both the Vamousse and combined samples. However, the t-test is robust to such departures from normality for samples of this size and was used to compare the two groups on the mean change proportions."||.537|.052|.020
72449822|NCT05565820|144418304|SUPERIORITY|"The nonparametric Mann-Whitney test was also conducted to check on the effect of the non-normality of the change proportions.~The null hypothesis is one-tailed. However, for consistency with the practice of reporting conservative p-values in clinical studies, the two-tailed p-value will be reported."|Mean Difference (Final Values)|0.178|STANDARD_ERROR_OF_MEAN|0.182||0.334|TWO_SIDED|95.0|-0.187|0.543||Alpha = .05 t: .976 df: 54 Mann-Whitney Z: 3.021 p(2-tailed) of Mann-Whitney Z: .003 Cohen's d = .294|t-test, 2 sided|Levine's test for violation of equality of variances nonsignificant; no df adjustment necessary.||"Null hypothesis: At Day 7 the proportion of decrease from baseline in the number of live lice in the Vamousse group does not exceed that in the Nix group.~The distribution of the Day 0 to Day 7 change proportions deviated significantly from normality by the Shapiro-Wilk test for both the Vamousse and combined samples. However, the t-test is robust to such departures from normality for samples of this size and was used to compare the two groups on their mean change proportions."||.543|-.187|.334
72449823|NCT05565820|144418304|SUPERIORITY|"The nonparametric Mann-Whitney test was also conducted to check on the effect of the non-normality of the change proportions.~The null hypothesis is one-tailed. However, for consistency with the practice of reporting conservative p-values in clinical studies, the two-tailed p-value will be reported."|Difference between proportions|0.235|STANDARD_ERROR_OF_MEAN|0.1034||0.037|TWO_SIDED|95.0|0.016|0.454||Alpha = .05 t: 2.276 df(adjusted, see comment below): 16.2 Mann-Whitney Z: 2.478 p(2-tailed) of Mann-Whitney Z: .013 Cohen's d = .947|t-test, 2 sided|Degrees of freedom for the t-test were adjusted for inequality of variances between the groups using the Satterthwaite correction: df(adj) = 16.2||"Null hypothesis: At Day 14 the proportion of decrease from baseline in the number of live lice in the Vamousse group does not exceed that in the Nix group.~The distribution of the Day 0 to Day 14 change proportion deviated significantly from normality by the Shapiro-Wilk test for both the Vamousse and combined samples. However, the t-test is robust to such departures from normality for samples of this size and was used to compare the two groups on the mean change proportions."||.454|.016|.037
72469682|NCT03635086|144463054|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|1.9||||0.794|TWO_SIDED|95.0|0.4|9.9|||ANOVA|||Day 182||9.9|0.4|0.7940
72469683|NCT03635086|144463054|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|1.6||||0.9169|TWO_SIDED|95.0|0.3|8.9|||ANOVA|||Day 182||8.9|0.3|0.9169
72469684|NCT03635086|144463054|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|1.0||||1|TWO_SIDED|95.0|0.2|5.2|||ANOVA|||Day 182||5.2|0.2|1.0000
72469954|NCT00559377|144463852|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.99||||0.98|TWO_SIDED||||||Regression, Cox|||This outcome is for comarison of FMISO T:Bmax to progression-free survival||||.98
72370332|NCT00035932|144251124|SUPERIORITY_OR_OTHER||Difference Estimate|-7.9|||||TWO_SIDED|95.0|-19.0|4.8|||||ATV 400/SQV - LPV/RTV|Observed Cases, Fasting LDL cholesterol||4.8|-19.0|
72370333|NCT00035932|144251124|SUPERIORITY_OR_OTHER||Difference Estimate|-24.8|||||TWO_SIDED|95.0|-38.6|-8.0|||||ATV 300/RTV - LPV/RTV|observed cases, fasting triglycerides||-8.0|-38.6|
72449824|NCT04047602|144418307|EQUIVALENCE|The observed proportion of evaluable patients with symptomatic radiation necrosis was calculated and tested against a baseline 6-month symptomatic radiation necrosis rate of 16% at a type I error rate of 5% using a one-sided binomial exact test. The null hypothesis is that the observed proportion is equivalent to 16% or 0.160.|Binomial Proportion|0.083||||0.234|TWO_SIDED|95.0|0.002|0.385||The p-value reported is the one-sided p-value from the exact equivalence binomial test using an alpha value of 0.05.|Exact Binomial Test||The binomial proportion 95% confidence intervals were calculated using the Clopper-Pearson (Exact) method.|The observed proportion of evaluable patients with symptomatic radiation necrosis was calculated and tested against a baseline 6-month symptomatic radiation necrosis rate of 16% at a type I error rate of 5% using a one-sided binomial exact test. The null hypothesis is that the observed proportion is equivalent to 16% or 0.160.||0.385|0.002|0.234
72449825|NCT04047602|144418310|OTHER|||||||0.285|||||||Klein Method|||The method of Klein et al., (Klein et.al., 2007) was used to compare the 12-month survival probabilities across SRS groups. The null hypothesis was that the survival probabilities were equal.||||0.285
72498847|NCT02338843|144527983|SUPERIORITY||Odds Ratio (OR)|7.95|||<|0.001|TWO_SIDED|95.0|4.76|13.3|||Regression, Logistic|Stratified logistic regression model. Adjusted by baseline MAP and APACHE II, vasopressin use and average NED 6 hours prior to randomization.||||13.3|4.76|<0.001
72498848|NCT03783195|144527990|OTHER|Both groups received the same intervention; however, their genetic make-up was different.|Mean Difference (Net)|-0.51|STANDARD_ERROR_OF_MEAN|0.59||0.4|TWO_SIDED|95.0|-1.77|0.76||All tests were individual tests.|Paired t-test|||The null hypothesis is that people with low GRS will have greater increase in liver fat as compared to high GRS group.||0.76|-1.77|0.40
72498849|NCT03783195|144527991|OTHER|Both groups received the same intervention; however, their genetic make-up was different.|Mean Difference (Net)|-0.38|STANDARD_ERROR_OF_MEAN|0.93||0.71|TWO_SIDED|95.0|-3.33|2.57||All tests were individual tests.|Paired t-test|||The null hypothesis is that people with low GRS will have greater increase in liver fat as compared to high GRS group.||2.57|-3.33|0.71
72498850|NCT03783195|144527992|OTHER|Both groups received the same intervention; however, their genetic make-up was different.|Mean Difference (Net)|-21.02|STANDARD_ERROR_OF_MEAN|4.8||0.0006|TWO_SIDED|95.0|-31.33|-10.72||All tests were individual tests.|Paired t-test|||The null hypothesis is that people with low GRS will have greater increase in VLDL-TG as compared to high GRS group.||-10.72|-31.33|0.0006
72498851|NCT03783195|144527993|OTHER|Both groups received the same intervention; however, their genetic make-up was different.|Median Difference (Net)|0.094|STANDARD_ERROR_OF_MEAN|0.17||0.59|TWO_SIDED|95.0|-0.27|0.46|||t-test, 2 sided|||This analysis focuses on the changes in the area under the curve (AUC) for measurements at different time points between the two GRS groups.||0.46|-0.27|0.59
72449826|NCT04047602|144418311|OTHER|||||||0.292|||||||Klein Method|||The method of Klein et al., (Klein et.al., 2007) was used to compare the 12-month survival probabilities across brain metastases groups. The null hypothesis was that the survival probabilities were equal.||||0.292
72498852|NCT03783195|144527994|OTHER|Both groups received the same intervention; however, their genetic make-up was different.|Mean Difference (Net)|-21.06|STANDARD_ERROR_OF_MEAN|7.77||0.017|TWO_SIDED|95.0|-37.75|-4.38||All tests were individual tests.|Paired t-test|||The null hypothesis is that people with low GRS will have greater increase in serum triglycerides as compared to high GRS group.||-4.38|-37.75|0.017
72498853|NCT03783195|144527995|OTHER|Both groups received the same intervention; however, their genetic make-up was different.|Mean Difference (Net)|-0.022|STANDARD_ERROR_OF_MEAN|0.16||0.89|TWO_SIDED|95.0|-0.37|0.33|||t-test, 2 sided|||This analysis focuses on the changes in the area under the curve (AUC) for measurements baseline and 3hr timepoints at week 0 and week 3 between the two GRS groups.||0.33|-0.37|0.89
72498854|NCT03783195|144527996|OTHER|Both groups received the same intervention; however, their genetic make-up was different.|Mean Difference (Net)|-4.36|STANDARD_ERROR_OF_MEAN|4.62||0.36|TWO_SIDED|95.0|-14.28|5.55||All tests were individual tests.|Paired t-test|||The null hypothesis is that people with low GRS will have less increase in HDL cholesterol as compared to high GRS group.||5.55|-14.28|0.36
72498855|NCT03783195|144527997|OTHER|Both groups received the same intervention; however, their genetic make-up was different.|Mean Difference (Net)|0.067|STANDARD_ERROR_OF_MEAN|0.16||0.67|TWO_SIDED|95.0|-0.27|0.4|||t-test, 2 sided|||||0.40|-0.27|0.67
72498856|NCT03783195|144527998|OTHER|Both groups received the same intervention; however, their genetic make-up was different.|Mean Difference (Net)|-21.03|STANDARD_ERROR_OF_MEAN|11.53||0.09|TWO_SIDED|95.0|-45.76|3.69||All tests were individual tests.|Paired t-test|||The null hypothesis is that people with low GRS will have greater increase in LDL cholesterol as compared to high GRS group.||3.69|-45.76|0.09
72561887|NCT00462839|144654632|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0||||Post-hoc comparison of 500ml, 1000ml and 2000ml volumes were greater in the non-calibrated drape first group. Post-hoc comparisons made using Bonferroni correct t-test for 8 comparisons.|ANOVA|||Repeated measures ANOVA comparing all levels of blood estimation (P=0.0002). Post-hoc comparisons using Bonferroni corrects t-tests.||||<0.05
72498857|NCT03783195|144527999|OTHER|Both groups received the same intervention; however, their genetic make-up was different.|Mean Difference (Net)|0.054|STANDARD_ERROR_OF_MEAN|0.13||0.69|TWO_SIDED|95.0|-0.24|0.34|||t-test, 2 sided|||||0.34|-0.24|0.69
72370334|NCT00035932|144251124|SUPERIORITY_OR_OTHER||Difference Estimate|-19.8|||||TWO_SIDED|95.0|-36.5|1.3|||||ATV 400/SQV - LPV/RTV|observed cases, fasting triglycerides||1.3|-36.5|
72498858|NCT03783195|144528000|OTHER|Both groups received the same intervention; however, their genetic make-up was different.|Mean Difference (Net)|-29.61|STANDARD_ERROR_OF_MEAN|15.28||0.07|TWO_SIDED|95.0|-62.39|3.17||All tests were individual tests.|Paired t-test|||The null hypothesis is that people with low GRS will have greater increase in total cholesterol as compared to high GRS group.||3.17|-62.39|0.07
72498859|NCT03783195|144528001|OTHER|Both groups received the same intervention; however, their genetic make-up was different.|Mean Difference (Net)|0.036|STANDARD_ERROR_OF_MEAN|0.14||0.8|TWO_SIDED|95.0|-0.26|0.33|||t-test, 2 sided|||||0.33|-0.26|0.80
72561888|NCT00462839|144654633|SUPERIORITY_OR_OTHER|||||||0.76||95.0|||||Chi-squared, Corrected|||||||0.76
72561889|NCT00462839|144654634|SUPERIORITY_OR_OTHER|||||||0.72||95.0|||||Chi-squared, Corrected|||||||0.72
72561890|NCT00462839|144654635|SUPERIORITY_OR_OTHER|||||||0.89||95.0|||||Chi-squared, Corrected|||||||0.89
72370335|NCT00035932|144251135|SUPERIORITY_OR_OTHER||time-averaged difference|0.14|||||TWO_SIDED|97.5|-0.13|0.41|||||ATV 300/RTV - LPV/RTV|overall||0.41|-0.13|
72449827|NCT04047602|144418312|OTHER|||||||0.289|||||||Klein Method|||The method of Klein et al., (Klein et.al., 2007) was used to compare the 12-month survival probabilities across ICI groups. The null hypothesis was that the survival probabilities were equal.||||0.289
72449828|NCT04047602|144418315|OTHER|||||||0.248|||||||Klein Method|||The method of Klein et al., (Klein et.al., 2007) was used to compare the 12-month survival probabilities across SRS groups. The null hypothesis was that the survival probabilities were equal.||||0.248
72561891|NCT01493596|144654639|OTHER|Comparison of event rates across dose groups.|percentage|14.3|||||TWO_SIDED||||||||There were a total of 5 non-serious adverse events for an AE rate of 14.3%|Descriptive statistics for evaluation of AEs|Descriptive statistics of adverse events|||
72561892|NCT04784637|144654641|SUPERIORITY|||||||0.064|||||||t-test, 2 sided|||||||0.064
72561893|NCT04784637|144654641|SUPERIORITY|||||||0.97|||||||t-test, 2 sided|||||||0.97
72561894|NCT04784637|144654642|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
72449829|NCT04047602|144418316|OTHER|||||||0.292|||||||Klein Method|||The method of Klein et al., (Klein et.al., 2007) was used to compare the 12-month survival probabilities across brain metastases groups. The null hypothesis was that the survival probabilities were equal.||||0.292
72449830|NCT04047602|144418317|OTHER|||||||0.289|||||||Klein Method|||The method of Klein et al., (Klein et.al., 2007) was used to compare the 12-month survival probabilities across ICI groups. The null hypothesis was that the survival probabilities were equal.||||0.289
72370336|NCT00035932|144251135|SUPERIORITY_OR_OTHER||time-averaged difference|0.11|||||TWO_SIDED|97.5|-0.16|0.38|||||ATV 300/RTV - LPV/RTV|last observation carried forward||0.38|-0.16|
72370337|NCT01388335|144251143|SUPERIORITY_OR_OTHER_LEGACY||Ratio|0.81|||||TWO_SIDED|90.0|0.691|0.95|||||Ratio of Geometric LS mean is for S-warfarin.|||0.950|0.691|
72449831|NCT05062330|144418330|SUPERIORITY||Odds Ratio (OR)|2.63|||<|0.0001|TWO_SIDED|95.0|1.67|4.13|||Generalized estimating equation|||||4.13|1.67|<0.0001
72449832|NCT01868997|144418393|SUPERIORITY||Odds Ratio (OR)|8.86|||<|0.001|TWO_SIDED|95.0|3.293|23.825||Odds ratio, 95% confidence interval, and P-value are obtained from a logistic regression model with treatment and smoking status as covariates.|Regression, Logistic|||||23.825|3.293|< 0.001
72449833|NCT01868997|144418394|SUPERIORITY||Difference in Least Squares Mean|10.97|STANDARD_ERROR_OF_MEAN|3.221||0.001|TWO_SIDED|95.0|4.561|17.375|||Mixed-Model Repeated Measures|||||17.375|4.561|0.001
72449834|NCT01868997|144418395|SUPERIORITY||Difference in Least Squares Mean|-2.31|STANDARD_ERROR_OF_MEAN|0.269|<|0.001|TWO_SIDED|95.0|-2.843|-1.772|||Mixed-Model Repeated Measures|||||-1.772|-2.843|< 0.001
72449835|NCT01868997|144418396|SUPERIORITY||Difference in Least Squares Mean|-1.59|STANDARD_ERROR_OF_MEAN|0.245|<|0.001|TWO_SIDED|95.0|-2.073|-1.098|||Mixed-Model Repeated Measures|||||-1.098|-2.073|< 0.001
72449836|NCT01868997|144418397|SUPERIORITY||Difference in Least Squares Mean|14.16|STANDARD_ERROR_OF_MEAN|3.827|<|0.001|TWO_SIDED|95.0|6.549|21.773|||Mixed-Model Repeated Measures|||||21.773|6.549|< 0.001
72449837|NCT01868997|144418398|SUPERIORITY||Difference in Least Squares Mean|6.32|STANDARD_ERROR_OF_MEAN|3.81||0.101|TWO_SIDED|95.0|-1.255|13.901|||Mixed-Model Repeated Measures|||||13.901|-1.255|0.101
72449838|NCT03209973|144418410|OTHER||||||<|0.0001||||||1-sided p-value was based on exact test of BGB-A317 versus historical rate of 0.35|Exact Binomial Test|Comparison with historical control values||||||<0.0001
72449839|NCT05163496|144418418|SUPERIORITY||Mean Difference (Net)|12.0|STANDARD_DEVIATION|0.8|<|0.001|TWO_SIDED||||||t-test, 2 sided|||The null hypothesis was that the mean change in MADRS score from the preparation 1 session to day 28 would be the same in both niacin and psilocybin groups. The alternative hypothesis was that the change in the psilocybin group would be greater than the change in the niacin group, with an assumed true effect size of 1.06 SD units based on findings in prior studies. With 15 participants per group, this study had 80% power to observe a statistically significant difference between groups.||||<.001
72449840|NCT00429364|144418490|SUPERIORITY_OR_OTHER_LEGACY|||||||0.08|TWO_SIDED|||||P values are based on a linear regression mixed-effect model comparing slopes under compound symmetry, with adjustment for baseline.|Mixed Models Analysis|||||||0.08
72449841|NCT00429364|144418491|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2|TWO_SIDED|||||P values are based on a linear regression mixed-effect model comparing slopes under compound symmetry, with adjustment for baseline.|Mixed Models Analysis|||||||0.20
72449842|NCT00429364|144418492|SUPERIORITY_OR_OTHER_LEGACY|||||||0.15|TWO_SIDED|||||P values are based on a linear regression mixed-effect model comparing slopes under compound symmetry, with adjustment for baseline.|Mixed Models Analysis|||||||0.15
72449843|NCT00429364|144418493|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3|TWO_SIDED|||||P values are based on a linear regression mixed-effect model comparing slopes under compound symmetry, with adjustment for baseline.|Mixed Models Analysis|||||||0.30
72449844|NCT00429364|144418494|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||P values are based on a linear regression mixed-effect model comparing slopes under compound symmetry, with adjustment for baseline.|Mixed Models Analysis|||||||<0.001
72449845|NCT00429364|144418495|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002|TWO_SIDED|||||P values are based on a linear regression mixed-effect model comparing slopes under compound symmetry, with adjustment for baseline.|Mixed Models Analysis|||||||0.002
72449846|NCT00429364|144418496|SUPERIORITY_OR_OTHER_LEGACY|||||||0.29|TWO_SIDED|||||P values are based on a linear regression mixed-effect model comparing slopes under compound symmetry, with adjustment for baseline.|Mixed Models Analysis|||||||0.29
72449847|NCT00429364|144418497|SUPERIORITY_OR_OTHER_LEGACY|||||||0.96|TWO_SIDED|||||Regression model adjusted for age at study visit.|Mixed Models Analysis|||||||0.96
72449848|NCT00429364|144418498|SUPERIORITY_OR_OTHER_LEGACY|||||||0.45|TWO_SIDED||||||Mixed Models Analysis|||||||0.45
72449849|NCT00429364|144418499|SUPERIORITY_OR_OTHER_LEGACY|||||||0.13|TWO_SIDED||||||Mixed Models Analysis|||||||0.13
72449850|NCT00429364|144418500|SUPERIORITY_OR_OTHER_LEGACY|||||||0.65|TWO_SIDED||||||Mixed Models Analysis|||||||0.65
72449851|NCT00429364|144418501|SUPERIORITY_OR_OTHER_LEGACY|||||||0.13|TWO_SIDED||||||Mixed Models Analysis|||||||0.13
72449852|NCT00429364|144418502|SUPERIORITY_OR_OTHER_LEGACY|||||||0.82|TWO_SIDED||||||Mixed Models Analysis|||||||0.82
72449853|NCT00429364|144418503|SUPERIORITY_OR_OTHER_LEGACY|||||||0.64|TWO_SIDED||||||Mixed Models Analysis|||||||0.64
72449854|NCT00429364|144418504|SUPERIORITY_OR_OTHER_LEGACY|||||||0.49|TWO_SIDED||||||Mixed Models Analysis|||||||0.49
72449855|NCT00429364|144418505|SUPERIORITY_OR_OTHER_LEGACY|||||||0.59|TWO_SIDED||||||Mixed Models Analysis|||||||0.59
72498860|NCT03783195|144528002|OTHER||Mean Difference (Net)|0.36|STANDARD_ERROR_OF_MEAN|0.25||0.17|TWO_SIDED|95.0|-0.18|0.91||All tests were individual tests.|Paired t-test|||The null hypothesis is that people with low GRS will have greater increase in serum uric acid as compared to high GRS group.||0.91|-0.18|0.17
72498861|NCT03783195|144528003|OTHER|Both groups received the same intervention; however, their genetic make-up was different.|Mean Difference (Net)|-0.217|STANDARD_ERROR_OF_MEAN|0.17||0.22|TWO_SIDED|95.0|-0.58|0.15|||t-test, 2 sided|||||0.15|-0.58|0.22
72498862|NCT03783195|144528004|OTHER|Both groups received the same intervention; however, their genetic make-up was different.|Mean Difference (Net)|-0.02|STANDARD_ERROR_OF_MEAN|0.007||0.04|TWO_SIDED|95.0|-0.03|-0.0009||All tests were individual tests.|Paired t-test|||The null hypothesis is that people with low GRS will have greater increase in serum ALT as compared to high GRS group.||-0.0009|-0.03|0.04
72498863|NCT03783195|144528005|OTHER|Both groups received the same intervention; however, their genetic make-up was different.|Mean Difference (Net)|-0.121|STANDARD_ERROR_OF_MEAN|0.19||0.53|TWO_SIDED|95.0|-0.52|0.28|||t-test, 2 sided|||||0.28|-0.52|0.53
72498864|NCT03783195|144528006|OTHER|Both groups received the same intervention; however, their genetic make-up was different.|Mean Difference (Net)|20.57|STANDARD_ERROR_OF_MEAN|17.5||0.25|TWO_SIDED|95.0|-16.9|58.08||All tests were individual tests.|Paired t-test|||The null hypothesis is that people with low GRS will have greater increase in serum AST as compared to high GRS group.||58.08|-16.9|0.25
72498865|NCT03783195|144528007|OTHER|Both groups received the same intervention; however, their genetic make-up was different.|Mean Difference (Net)|-0.22|STANDARD_ERROR_OF_MEAN|0.17||0.2|TWO_SIDED|95.0|-0.59|0.13|||t-test, 2 sided|||||0.13|-0.59|0.20
72498866|NCT03783195|144528008|OTHER||Mean Difference (Net)|28.95|STANDARD_ERROR_OF_MEAN|21.78||0.21|TWO_SIDED|95.0|-17.76|75.67||All tests were individual tests.|Paired t-test|||The null hypothesis is that people with low GRS will have greater increase in serum ALP as compared to high GRS group.||75.67|-17.76|0.21
72498867|NCT03783195|144528009|OTHER|Both groups received the same intervention; however, their genetic make-up was different.|Mean Difference (Net)|0.054|STANDARD_ERROR_OF_MEAN|0.12||0.67|TWO_SIDED|95.0|-0.214|0.321|||t-test, 2 sided|||||0.321|-0.214|0.67
72498868|NCT03783195|144528010|OTHER|Both groups received the same intervention; however, their genetic make-up was different.|Mean Difference (Net)|0.08|STANDARD_ERROR_OF_MEAN|0.09||0.41|TWO_SIDED|95.0|-0.12|0.28||All tests were individual tests.|Paired t-test|||The null hypothesis is that people with low GRS will have greater increase in serum GGT as compared to high GRS group.||0.28|-0.12|0.41
72498869|NCT03783195|144528011|OTHER|Both groups received the same intervention; however, their genetic make-up was different|Mean Difference (Net)|-0.109|STANDARD_ERROR_OF_MEAN|0.15||0.49|TWO_SIDED|95.0|-0.44|0.22|||t-test, 2 sided|||||0.22|-0.44|0.49
72498870|NCT01147926|144528055|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
72498871|NCT01355289|144528084|SUPERIORITY_OR_OTHER||Difference in % of Responders|31.62||||0.0236|TWO_SIDED|95.0|5.39|57.84|||Cochran-Mantel-Haenszel|||||57.84|5.39|0.0236
72498872|NCT01355289|144528084|SUPERIORITY_OR_OTHER||Difference in % of Responders|60.78||||0.0003|TWO_SIDED|95.0|36.3|85.27|||Cochran-Mantel-Haenszel|||||85.27|36.30|0.0003
72498873|NCT01355289|144528084|SUPERIORITY_OR_OTHER||Difference in % of Responders|58.4||||0.0003|TWO_SIDED|95.0|30.92|85.88|||Cochran-Mantel-Haenszel|||||85.88|30.92|0.0003
72498874|NCT00813995|144528096|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Pairwise comparison|ANCOVA|||||||<.001
72498875|NCT02507349|144528101|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||Time-by-treatment interaction||||<0.0001
72498876|NCT02507349|144528101|SUPERIORITY|||||||0.0033|||||||Mixed Models Analysis|||Three-way interaction effect (treatment, polynomial time, and age group 1) where age group 1 is defined by 0 (reference) if \<=35; 1 if (35\<age\<=49); 2 if age \>49.||||0.0033
72498877|NCT02507349|144528101|SUPERIORITY|||||||0.3164|||||||Mixed Models Analysis|||Three-way interaction effect (treatment, polynomial time, and SMI group). Participants with a diagnosis of major depression, schizoaffective or schizophrenia were classified into the SMI group and the reference group (Non-SMI) included diagnosis of anxiety, PTSD, depression/dysthymia/depression nos.||||0.3164
72498878|NCT02507349|144528101|SUPERIORITY|||||||0.0482|||||||Mixed Models Analysis|||Three-way interaction effect of time, treatment, and the basis subgroups (no symptoms =group 1; at least 1 severe symptom = group 2)||||0.0482
72561895|NCT04784637|144654642|SUPERIORITY|||||||0.93|||||||t-test, 2 sided|||||||0.93
72498879|NCT02507349|144528101|SUPERIORITY|||||||0.9928|||||||Mixed Models Analysis|||Three-way interaction of Treatment, time, and subgroup of side effects. Subgroup of side effect= 0 if the response to the medication side effects question at baseline is 1, 2, or 3 (i.e. subgroup of participants who are minimally bothered by medication side effects at baseline); Subgroup of side effect= 1 if the response to the medication side effects question at baseline is 4-10 (i.e. subgroup of participants who are moderately or very bothered by medication side effects at baseline)||||0.9928
72498880|NCT02507349|144528102|SUPERIORITY|||||||0.6243|||||||Mixed Models Analysis|||Time-by-treatment interaction||||0.6243
72498881|NCT02507349|144528102|SUPERIORITY|||||||0.1969|||||||Mixed Models Analysis|||Test for change over time from baseline (Marginal Effect of Time)||||0.1969
72498882|NCT02507349|144528102|SUPERIORITY|||||||0.0042|||||||Mixed Models Analysis|||Three-way interaction effect (treatment, polynomial time, and age group 1) where age group 1 is defined by 0 (reference) if \<=35; 1 if (35\<age\<=49); 2 if age \>49||||0.0042
72498883|NCT02507349|144528102|SUPERIORITY|||||||0.0002|||||||Mixed Models Analysis|||Three-way interaction effect (treatment, polynomial time, and SMI group). Participants with a diagnosis of major depression, schizoaffective or schizophrenia were classified into the SMI group and the reference group (Non-SMI) included diagnosis of anxiety, PTSD, depression/dysthymia/depression nos.||||0.0002
72498884|NCT02507349|144528102|SUPERIORITY|||||||0.7254|||||||Mixed Models Analysis|||Three-way interaction effect of time, treatment, and the basis subgroups (no symptoms =group 1; at least 1 severe symptom = group 2)||||0.7254
72561896|NCT03919695|144654644|SUPERIORITY||Odds Ratio (OR)|0.29||||0.002|TWO_SIDED|95.0|0.11|0.73|||GEE model specifying a logistic distribu||time x arm effect for the comparison at 6-month follow-up|Generalized Estimating Equations (GEE) model specifying a logistic distribution examining the time x arm interaction||.73|.11|.002
72561897|NCT03259789|144654650|SUPERIORITY||Difference of LS Means|-0.53|||<|0.0001|TWO_SIDED|95.0|-0.74|-0.32|||Mixed-effects repeated measures|Mixed-effects repeated measures analysis includes country, treatment, visit, treatment and baseline HbA1c value as fixed effect covariates||||-0.32|-0.74|< 0.0001
72449856|NCT00429364|144418507|SUPERIORITY_OR_OTHER_LEGACY|||||||0.16|TWO_SIDED||||||Log Rank|||||||0.16
72449857|NCT00429364|144418509|SUPERIORITY_OR_OTHER_LEGACY|||||||0.13|TWO_SIDED||||||Log Rank|||||||0.13
72449858|NCT00429364|144418511|SUPERIORITY_OR_OTHER_LEGACY|||||||0.32|TWO_SIDED||||||Log Rank|||||||0.32
72449859|NCT00429364|144418513|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1|TWO_SIDED||||||Log Rank|||||||0.10
72449860|NCT00661141|144418537|SUPERIORITY|||||||0.8727||||||Overall p-value testing cohort difference from ANOVA|ANOVA|||1.0 mg/kg Cohort, 3.0 mg/kg cohort, 5.0 mg/kg cohort||||0.8727
72449861|NCT00661141|144418540|SUPERIORITY|||||||0.0023||||||Overall p-value testing cohort difference from ANOVA|ANOVA|||1.0 mg/kg Cohort, 3.0 mg/kg cohort, 5.0 mg/kg cohort||||0.0023
72449862|NCT00661141|144418540|SUPERIORITY|||||||0.386||||||P-values for pairwise comparison between cohorts from ANOVA|ANOVA|||1.0 mg/kg Cohort, 3.0 mg/kg cohort||||0.386
72449863|NCT00661141|144418540|SUPERIORITY|||||||0.0006||||||P-values for pairwise comparison between cohorts from ANOVA|ANOVA|||1.0 mg/kg, 5.0 mg/kg||||0.0006
72449864|NCT00661141|144418540|SUPERIORITY|||||||0.0154||||||P-values for pairwise comparison between cohorts from ANOVA|ANOVA|||3.0 mg/kg, 5.0 mg/kg||||0.0154
72449865|NCT00661141|144418547|SUPERIORITY||ratio of parameter means|115.57|||||TWO_SIDED|90.0|90.45|147.67|||||Ratio of parameter means (Antizol/placebo, expressed as a percent), transformed back to the linear scale. 90% confidence interval for ratio of parameter means (expressed as a percent), transformed back to the linear scale.|||147.67|90.45|
72449866|NCT00661141|144418547|SUPERIORITY||ratio of parameter means|126.05|||||TWO_SIDED|90.0|101.94|155.87|||||Ratio of parameter means (Antizol/placebo, expressed as a percent), transformed back to the linear scale. 90% confidence interval for ratio of parameter means (expressed as a percent), transformed back to the linear scale.|||155.87|101.94|
72449867|NCT00661141|144418547|SUPERIORITY||ratio of parameter means|137.58|||||TWO_SIDED|90.0|115.66|163.65|||||Ratio of parameter means (Antizol/placebo, expressed as a percent), transformed back to the linear scale. 90% confidence interval for ratio of parameter means (expressed as a percent), transformed back to the linear scale.|||163.65|115.66|
72498885|NCT02507349|144528102|SUPERIORITY|||||||0.058|||||||Mixed Models Analysis|||Three-way interaction of Treatment, time, and subgroup of side effects. Subgroup of side effect= 0 if the response to the medication side effects question at baseline is 1, 2, or 3 (i.e. subgroup of participants who are minimally bothered by medication side effects at baseline); Subgroup of side effect= 1 if the response to the medication side effects question at baseline is 4-10 (i.e. subgroup of participants who are moderately or very bothered by medication side effects at baseline)||||0.0580
72449868|NCT00661141|144418547|SUPERIORITY||ratio of parameter means|82.4|||||TWO_SIDED|90.0|62.83|108.07|||||Ratio of parameter means (Antizol/placebo, expressed as a percent), transformed back to the linear scale. 90% confidence interval for ratio of parameter means (expressed as a percent), transformed back to the linear scale.|||108.07|62.83|
72498886|NCT02507349|144528103|SUPERIORITY|||||||0.4677|||||||Mixed Models Analysis|||Time-by-treatment interaction||||0.4677
72449869|NCT00661141|144418547|SUPERIORITY||ratio of parameter means|115.25|||||TWO_SIDED|90.0|91.19|145.67|||||Ratio of parameter means (Antizol/placebo, expressed as a percent), transformed back to the linear scale. 90% confidence interval for ratio of parameter means (expressed as a percent), transformed back to the linear scale.|3 participants in Cohort 3 had some residual 4-MP detected on Day 2 (Placebo treatment). As a result, the data for the participants on Day 2 were excluded from these statistical analyses, which could be compared with the analyses below where all available data were included.||145.67|91.19|
72449870|NCT00661141|144418547|SUPERIORITY||ratio of parameter means|112.64|||||TWO_SIDED|90.0|96.14|131.98|||||Ratio of parameter means (Antizol/placebo, expressed as a percent), transformed back to the linear scale. 90% confidence interval for ratio of parameter means (expressed as a percent), transformed back to the linear scale.|Analyses for Cohort 3 where all available data were included.||131.98|96.14|
72449871|NCT00661141|144418550|SUPERIORITY||ratio of parameter means|139.63|||||TWO_SIDED|90.0|92.18|211.51|||||Ratio of parameter means (Antizol/placebo, expressed as a percent), transformed back to the linear scale. 90% confidence interval for ratio of parameter means (expressed as a percent), transformed back to the linear scale.|||211.51|92.18|
72449872|NCT00661141|144418550|SUPERIORITY||ratio of parameter means|120.76|||||TWO_SIDED|90.0|108.8|134.03|||||Ratio of parameter means (Antizol/placebo, expressed as a percent), transformed back to the linear scale. 90% confidence interval for ratio of parameter means (expressed as a percent), transformed back to the linear scale.|||134.03|108.80|
72449873|NCT00661141|144418550|SUPERIORITY||ratio of parameter means|143.39|||||TWO_SIDED|90.0|107.72|190.87|||||Ratio of parameter means (Antizol/placebo, expressed as a percent), transformed back to the linear scale. 90% confidence interval for ratio of parameter means (expressed as a percent), transformed back to the linear scale.|||190.87|107.72|
72449874|NCT00661141|144418550|SUPERIORITY||ratio of parameter means|103.13|||||TWO_SIDED|90.0|84.35|126.1|||||Ratio of parameter means (Antizol/placebo, expressed as a percent), transformed back to the linear scale. 90% confidence interval for ratio of parameter means (expressed as a percent), transformed back to the linear scale.|||126.10|84.35|
72449875|NCT00661141|144418550|SUPERIORITY||ratio of parameter means|123.17|||||TWO_SIDED|90.0|108.61|139.67|||||Ratio of parameter means (Antizol/placebo, expressed as a percent), transformed back to the linear scale. 90% confidence interval for ratio of parameter means (expressed as a percent), transformed back to the linear scale.|3 participants in Cohort 3 had some residual 4-MP detected on Day 2 (Placebo treatment). As a result, the data for the participants on Day 2 were excluded from these statistical analyses, which could be compared with the analyses below where all available data were included.||139.67|108.61|
72498887|NCT02507349|144528103|SUPERIORITY|||||||0.094|||||||Mixed Models Analysis|||Test for change over time from baseline (Marginal Effect of Time)||||0.0940
72370338|NCT01388335|144251143|SUPERIORITY_OR_OTHER_LEGACY||Ratio|0.912|||||TWO_SIDED|90.0|0.815|1.02|||||Ratio of Geometric LS mean is for R-warfarin.|||1.02|0.815|
72449876|NCT00661141|144418550|SUPERIORITY||ratio of parameter means|137.17|||||TWO_SIDED|90.0|123.3|152.59|||||Ratio of parameter means (Antizol/placebo, expressed as a percent), transformed back to the linear scale. 90% confidence interval for ratio of parameter means (expressed as a percent), transformed back to the linear scale.|Analyses for Cohort 3 where all available data were included.||152.59|123.30|
72449877|NCT00661141|144418552|SUPERIORITY||ratio of parameter means|121.81|||||TWO_SIDED|90.0|108.42|136.84|||||Ratio of parameter means (Antizol/placebo, expressed as a percent), transformed back to the linear scale. 90% confidence interval for ratio of parameter means (expressed as a percent), transformed back to the linear scale.|||136.84|108.42|
72449878|NCT00661141|144418552|SUPERIORITY||ratio of parameter means|123.7|||||TWO_SIDED|90.0|93.55|163.56|||||Ratio of parameter means (Antizol/placebo, expressed as a percent), transformed back to the linear scale. 90% confidence interval for ratio of parameter means (expressed as a percent), transformed back to the linear scale.|||163.56|93.55|
72449879|NCT00661141|144418552|SUPERIORITY||ratio of parameter means|150.33|||||TWO_SIDED|90.0|93.14|242.63|||||Ratio of parameter means (Antizol/placebo, expressed as a percent), transformed back to the linear scale. 90% confidence interval for ratio of parameter means (expressed as a percent), transformed back to the linear scale.|||242.63|93.14|
72449880|NCT00661141|144418552|SUPERIORITY||ratio of parameter means|122.83|||||TWO_SIDED|90.0|82.45|183.0|||||Ratio of parameter means (Antizol/placebo, expressed as a percent), transformed back to the linear scale. 90% confidence interval for ratio of parameter means (expressed as a percent), transformed back to the linear scale.|Analysis for Cohort 3 where all available data were included.||183.00|82.45|
72449881|NCT00661141|144418558|SUPERIORITY||ratio of parameter means|69.13|||||TWO_SIDED|90.0|48.88|97.78|||||Ratio of parameter means (Antizol/placebo, expressed as a percent), transformed back to the linear scale. 90% confidence interval for ratio of parameter means (expressed as a percent), transformed back to the linear scale.|||97.78|48.88|
72449882|NCT00661141|144418558|SUPERIORITY||ratio of parameter means|124.46|||||TWO_SIDED|90.0|88.77|174.5|||||Ratio of parameter means (Antizol/placebo, expressed as a percent), transformed back to the linear scale. 90% confidence interval for ratio of parameter means (expressed as a percent), transformed back to the linear scale.|||174.50|88.77|
72449883|NCT00661141|144418558|SUPERIORITY||ratio of parameter means|105.31|||||TWO_SIDED|90.0|89.24|124.27|||||Ratio of parameter means (Antizol/placebo, expressed as a percent), transformed back to the linear scale. 90% confidence interval for ratio of parameter means (expressed as a percent), transformed back to the linear scale.|||124.27|89.24|
72449884|NCT00661141|144418558|SUPERIORITY||ratio of parameter means|88.6|||||TWO_SIDED|90.0|56.66|138.54|||||Ratio of parameter means (Antizol/placebo, expressed as a percent), transformed back to the linear scale. 90% confidence interval for ratio of parameter means (expressed as a percent), transformed back to the linear scale.|||138.54|56.66|
72449885|NCT00661141|144418558|SUPERIORITY||ratio of parameter means|70.77|||||TWO_SIDED|90.0|34.16|146.59|||||Ratio of parameter means (Antizol/placebo, expressed as a percent), transformed back to the linear scale. 90% confidence interval for ratio of parameter means (expressed as a percent), transformed back to the linear scale.|3 participants in Cohort 3 had some residual 4-MP detected on Day 2 (Placebo treatment). As a result, the data for the participants on Day 2 were excluded from these statistical analyses, which could be compared with the analyses below where all available data were included.||146.59|34.16|
72449886|NCT00661141|144418558|SUPERIORITY||ratio of parameter means|86.04|||||TWO_SIDED|90.0|55.78|132.73|||||Ratio of parameter means (Antizol/placebo, expressed as a percent), transformed back to the linear scale. 90% confidence interval for ratio of parameter means (expressed as a percent), transformed back to the linear scale.|Analyses for Cohort 3 where all available data were included.||132.73|55.78|
72449887|NCT00661141|144418561|SUPERIORITY||ratio of parameter means|90.2|||||TWO_SIDED|90.0|69.54|117.0|||||Ratio of parameter means (Antizol/placebo, expressed as a percent), transformed back to the linear scale. 90% confidence interval for ratio of parameter means (expressed as a percent), transformed back to the linear scale.|||117.00|69.54|
72449888|NCT00661141|144418561|SUPERIORITY||ratio of parameter means|112.28|||||TWO_SIDED|90.0|103.72|121.54|||||Ratio of parameter means (Antizol/placebo, expressed as a percent), transformed back to the linear scale. 90% confidence interval for ratio of parameter means (expressed as a percent), transformed back to the linear scale.|||121.54|103.72|
72449889|NCT00661141|144418561|SUPERIORITY||ratio of parameter means|106.08|||||TWO_SIDED|90.0|96.81|116.24|||||Ratio of parameter means (Antizol/placebo, expressed as a percent), transformed back to the linear scale. 90% confidence interval for ratio of parameter means (expressed as a percent), transformed back to the linear scale.|||116.24|96.81|
72498888|NCT02507349|144528104|SUPERIORITY|||||||0.8733|||||||Mixed Models Analysis|||Time-by-treatment interaction||||0.8733
72449890|NCT00661141|144418561|SUPERIORITY||ratio of parameter means|104.12|||||TWO_SIDED|90.0|83.5|129.84|||||Ratio of parameter means (Antizol/placebo, expressed as a percent), transformed back to the linear scale. 90% confidence interval for ratio of parameter means (expressed as a percent), transformed back to the linear scale.|||129.84|83.50|
72449891|NCT00661141|144418561|SUPERIORITY||ratio of parameter means|100.41|||||TWO_SIDED|90.0|77.86|129.49|||||Ratio of parameter means (Antizol/placebo, expressed as a percent), transformed back to the linear scale. 90% confidence interval for ratio of parameter means (expressed as a percent), transformed back to the linear scale.|3 participants in Cohort 3 had some residual 4-MP detected on Day 2 (Placebo treatment). As a result, the data for the participants on Day 2 were excluded from these statistical analyses, which could be compared with the analyses below where all available data were included.||129.49|77.86|
72498889|NCT02507349|144528104|SUPERIORITY|||||||0.0113|||||||Mixed Models Analysis|||Test for change over time from baseline (Marginal Effect of Time)||||0.0113
72498890|NCT02507349|144528105|SUPERIORITY|||||||0.2328|||||||Mixed Models Analysis|||Time-by-treatment interaction||||0.2328
72498891|NCT02507349|144528105|SUPERIORITY|||||||0.0005|||||||Mixed Models Analysis|||Test for change over time from baseline (Marginal Effect of Time)||||0.0005
72449892|NCT00661141|144418561|SUPERIORITY||ratio of parameter means|94.7|||||TWO_SIDED|90.0|82.7|108.42|||||Ratio of parameter means (Antizol/placebo, expressed as a percent), transformed back to the linear scale. 90% confidence interval for ratio of parameter means (expressed as a percent), transformed back to the linear scale.|Analyses for Cohort 3 where all available data were included.||108.42|82.70|
72449893|NCT00661141|144418563|SUPERIORITY||ratio of parameter means|94.15|||||TWO_SIDED|90.0|78.01|1113.63|||||Ratio of parameter means (Antizol/placebo, expressed as a percent), transformed back to the linear scale. 90% confidence interval for ratio of parameter means (expressed as a percent), transformed back to the linear scale.|||1113.63|78.01|
72498892|NCT02507349|144528106|SUPERIORITY|||||||0.0033|||||||Mixed Models Analysis|||Time-by-treatment interaction||||0.0033
72498893|NCT02507349|144528107|SUPERIORITY|||||||0.1649|||||||Mixed Models Analysis|||Time-by-treatment interaction||||0.1649
72498894|NCT02507349|144528107|SUPERIORITY|||||||0.0016|||||||Mixed Models Analysis|||Test for change over time from baseline (Marginal Effect of Time)||||0.0016
72498895|NCT02507349|144528108|SUPERIORITY|||||||0.008|||||||Mixed Models Analysis|||Time-by-treatment interaction||||0.0080
72498896|NCT02507349|144528109|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||||||<0.0001
72498897|NCT02507349|144528110|SUPERIORITY|||||||0.0003|||||||Mixed Models Analysis|||||||0.0003
72498898|NCT03618030|144528123|OTHER|||||||0.0003|||||||ANOVA|||The primary efficacy analysis used a mixed-model repeated measures (MMRM) analysis on the full day laboratory classroom PERMP-T scores.||||.0003
72498899|NCT00473876|144528148|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.38||||0.08||95.0|||||t-test, 1 sided|The differences between baseline and post-intervention (4 months) was analyzed using independent t-test, comparing metformin and placebo.||Null hypothesis: Metformin has no effect on peak VO2. We targetted 66 subjects and power calculation based on our previous observational study of CHF with insulin resistance with mean peak VO2 of 11.||||0.08
72498900|NCT00473876|144528149|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.45|STANDARD_DEVIATION|10.72||0.034||95.0|||||t-test, 1 sided|Compare between metformin and placebo arm.||Null hypothesis: Metformin has no effect on the ratio between VCO2 (production of CO2) and VE (ventilation), it is also called the VE/VCO2 slope||||0.034
72498901|NCT01032629|144528150|SUPERIORITY||Hazard Ratio (HR)|0.93|||=|0.4576|TWO_SIDED|95.0|0.78|1.12|||Cox proportional hazard model|||Comparison for canagliflozin versus placebo is reported here.||1.12|0.78|=0.4576
72498902|NCT01032629|144528150|SUPERIORITY||Hazard Ratio (HR)|0.83|||=|0.0467|TWO_SIDED|95.0|0.68|1.0|||Cox proportional hazard model|||Comparison for canagliflozin versus placebo is reported here.||1.00|0.68|=0.0467
72498903|NCT01032629|144528150|SUPERIORITY||Hazard Ratio (HR)|0.88||||0.112|TWO_SIDED|95.0|0.75|1.03|||Cox proportional hazard method|||Comparison for canagliflozin versus placebo is reported here.||1.03|0.75|0.1120
72498904|NCT01032629|144528151|SUPERIORITY||Difference of Least Square Mean|2.79|STANDARD_ERROR_OF_MEAN|2.224|=|0.21|TWO_SIDED|95.0|-1.571|7.154|||ANCOVA|||Comparison for canagliflozin versus placebo is reported here.||7.154|-1.571|=0.210
72498905|NCT01032629|144528151|SUPERIORITY||Difference of Least Square Mean|4.07|STANDARD_ERROR_OF_MEAN|2.261|=|0.072|TWO_SIDED|95.0|-0.368|8.504|||ANCOVA|||Comparison for canagliflozin versus placebo is reported here.||8.504|-0.368|=0.072
72498906|NCT01032629|144528152|SUPERIORITY||Odds Ratio (OR)|0.8|||||TWO_SIDED|95.0|0.67|0.97|||Regression, Logistic|||Comparison for canagliflozin versus placebo is reported here.||0.97|0.67|
72619583|NCT02070380|144770023|SUPERIORITY_OR_OTHER||∆Percentage MH better minus DM better|7.3||||0.1295|TWO_SIDED|95.0|-2.0|16.5||Only 1 primary endpoint, no adjustment for multiple comparisons and the a priori threshold for statistical significance was 0.05.|Wilcoxon signed-rank test.||Difference in percentage MultiHance better minus percentage Dotarem better (%) , 2-sided 95% confidence interval was estimated using Altman's general approximate normal method.|"Null hypotheses:~A 0.05 mmol/kg dose of MULTIHANCE is equal to a 0.1 mmol/kg dose of DOTAREM, in terms of the assessment of global diagnostic preference in an off-site pre-dose plus post-dose paired global assessment."||16.5|-2.0|0.1295
72498907|NCT01032629|144528152|SUPERIORITY||Odds Ratio (OR)|0.71|||||TWO_SIDED|95.0|0.58|0.85|||Regression, Logistic|||Comparison for canagliflozin versus placebo is reported here.||0.85|0.58|
72498908|NCT01032629|144528153|OTHER||Difference of Least Square Mean|-0.03|STANDARD_ERROR_OF_MEAN|0.205|||TWO_SIDED|95.0|-0.429|0.374||||||Comparison for canagliflozin versus placebo is reported here.||0.374|-0.429|
72498909|NCT01032629|144528153|OTHER||Difference of Least Square Mean|0.33|STANDARD_ERROR_OF_MEAN|0.206|||TWO_SIDED|95.0|-0.079|0.731||||||Comparison for canagliflozin versus placebo is reported here.||0.731|-0.079|
72498910|NCT01032629|144528154|OTHER||Geometric mean ratio|0.87|||||TWO_SIDED|95.0|0.8|0.94||||||Comparison for canagliflozin versus placebo is reported here.||0.940|0.800|
72498911|NCT01032629|144528154|OTHER||Geometric mean ratio|0.84|||||TWO_SIDED|95.0|0.77|0.91||||||Comparison for canagliflozin versus placebo is reported here.||0.910|0.770|
72498912|NCT01032629|144528155|OTHER||Difference of Least Square Mean|1.68|STANDARD_ERROR_OF_MEAN|0.55|||TWO_SIDED|95.0|0.599|2.755||||||Comparison for canagliflozin versus placebo is reported here.||2.755|0.599|
72498913|NCT01032629|144528155|OTHER||Difference of Least Square Mean|1.24|STANDARD_ERROR_OF_MEAN|0.553|||TWO_SIDED|95.0|0.16|2.328||||||Comparison for canagliflozin versus placebo is reported here.||2.328|0.160|
72498914|NCT01032629|144528156|OTHER||Difference of Least Square Mean|-0.27|STANDARD_ERROR_OF_MEAN|0.045|||TWO_SIDED|95.0|-0.355|-0.177||||||Comparison for canagliflozin versus placebo is reported here.||-0.177|-0.355|
72498915|NCT01032629|144528156|OTHER||Difference of Least Square Mean|-0.32|STANDARD_ERROR_OF_MEAN|0.046|||TWO_SIDED|95.0|-0.405|-0.227||||||Comparison for canagliflozin versus placebo is reported here.||-0.227|-0.405|
72498916|NCT01032629|144528157|OTHER||Difference of Least Square Mean|-0.58|STANDARD_ERROR_OF_MEAN|0.107|||TWO_SIDED|95.0|-0.794|-0.374||||||Comparison for canagliflozin versus placebo is reported here.||-0.374|-0.794|
72498917|NCT01032629|144528157|OTHER||Difference of Least Square Mean|-0.73|STANDARD_ERROR_OF_MEAN|0.108|||TWO_SIDED|95.0|-0.945|-0.523||||||Comparison for canagliflozin versus placebo is reported here.||-0.523|-0.945|
72498918|NCT01032629|144528158|OTHER||Difference of Least Square Mean|-2.96|STANDARD_ERROR_OF_MEAN|0.26||||95.0|-3.472|-2.454||||||Comparison for canagliflozin versus placebo is reported here.||-2.454|-3.472|
72498919|NCT01032629|144528158|OTHER||Difference of Least Square Mean|-3.61|STANDARD_ERROR_OF_MEAN|0.261|||TWO_SIDED|95.0|-4.125|-3.103||||||Comparison for canagliflozin versus placebo is reported here.||-3.103|-4.125|
72498920|NCT01032629|144528159|OTHER||Difference of Least Square Mean|-2.96|STANDARD_ERROR_OF_MEAN|0.532|||TWO_SIDED|95.0|-3.998|-1.914||||||Statistical analysis (Systolic blood pressure) Comparison for canagliflozin versus placebo is reported here.||-1.914|-3.998|
72498921|NCT01032629|144528159|OTHER||Difference of Least Square Mean|-4.53|STANDARD_ERROR_OF_MEAN|0.534|||TWO_SIDED|95.0|-5.579|-3.484||||||Statistical analysis (Systolic blood pressure) Comparison for canagliflozin versus placebo is reported here.||-3.484|-5.579|
72498922|NCT01032629|144528159|OTHER||Difference of Least Square Mean|-0.82|STANDARD_ERROR_OF_MEAN|0.314|||TWO_SIDED|95.0|-1.437|-0.205||||||Statistical analysis (Diastolic blood pressure) Comparison for canagliflozin versus placebo is reported here.||-0.205|-1.437|
72498923|NCT01032629|144528159|OTHER||Difference of Least Square Mean|-1.63|STANDARD_ERROR_OF_MEAN|0.316|||TWO_SIDED|95.0|-2.245|-1.007||||||Statistical analysis (Diastolic blood pressure) Comparison for canagliflozin versus placebo is reported here.||-1.007|-2.245|
72498924|NCT01032629|144528160|OTHER||Hodges-Lehman Estimate|0.02|||||TWO_SIDED|95.0|-0.04|0.07||||||Comparison for canagliflozin versus placebo is reported here.||0.070|-0.040|
72498925|NCT01032629|144528160|OTHER||Hodges-Lehman Estimate|0.02|||||TWO_SIDED|95.0|-0.03|0.08||||||Comparison for canagliflozin versus placebo is reported here.||0.080|-0.030|
72498926|NCT01032629|144528161|OTHER||Difference of Least Square Mean|0.18|STANDARD_ERROR_OF_MEAN|0.039|||TWO_SIDED|95.0|0.105|0.259||||||Statistical analysis (Cholesterol) Comparison for canagliflozin versus placebo is reported here.||0.259|0.105|
72449894|NCT00661141|144418563|SUPERIORITY||ratio of parameter means|107.05|||||TWO_SIDED|90.0|87.42|131.1|||||Ratio of parameter means (Antizol/placebo, expressed as a percent), transformed back to the linear scale. 90% confidence interval for ratio of parameter means (expressed as a percent), transformed back to the linear scale.|3 participants in Cohort 3 had some residual 4-MP detected on Day 2 (Placebo treatment). As a result, the data for the participants on Day 2 were excluded from these statistical analyses, which could be compared with the analyses below where all available data were included.||131.10|87.42|
72619584|NCT02070380|144770023|SUPERIORITY_OR_OTHER||∆Percentage MH better minus DM better|79.0|||<|0.0001|TWO_SIDED|95.0|67.1|91.0||Only 1 primary endpoint, no adjustment for multiple comparisons and the a priori threshold for statistical significance was 0.05.|Wilcoxon signed rank test||Difference in percentage MultiHance better minus percentage Dotarem better (%) , 2-sided 95% confidence interval was estimated using Altman's general approximate normal method.|"Null hypotheses:~A 0.1 mmol/kg dose of MULTIHANCE is equal to a 0.1 mmol/kg dose of DOTAREM, in terms of the assessment of global diagnostic preference in an off-site pre-dose plus postdose paired global assessment"||91.0|67.1|<0.0001
72619585|NCT02070380|144770023|SUPERIORITY_OR_OTHER||Percentage MH better minus DM better|-2.1||||0.7503|TWO_SIDED|95.0|-15.0|10.7||Only 1 primary endpoint, no adjustment for multiple comparisons and the a priori threshold for statistical significance was 0.05.|Wilcoxon signed rank test||Difference in percentage MultiHance better minus percentage Dotarem better (%) , 2-sided 95% confidence interval was estimated using Altman's general approximate normal method.|"Null hypotheses:~A 0.05 mmol/kg dose of MULTIHANCE is equal to a 0.1 mmol/kg dose of DOTAREM, in terms of the assessment of global diagnostic preference in an off-site pre-dose plus post-dose paired global assessment."||10.7|-15.0|0.7503
72619586|NCT02070380|144770023|SUPERIORITY_OR_OTHER||∆Percentage MH better minus DM better|66.1|||<|0.0001|TWO_SIDED|95.0|52.8|79.5||Only 1 primary endpoint, no adjustment for multiple comparisons and the a priori threshold for statistical significance was 0.05.|Wilcoxon signed rank test||Difference in percentage MultiHance better minus percentage Dotarem better (%) , 2-sided 95% confidence interval was estimated using Altman's general approximate normal method.|"Null hypotheses:~A 0.1 mmol/kg dose of MULTIHANCE is equal to a 0.1 mmol/kg dose of DOTAREM, in terms of the assessment of global diagnostic preference in an off-site pre-dose plus post-dose paired global assessment"||79.5|52.8|<0.0001
72449895|NCT00661141|144418563|SUPERIORITY||ratio of parameter means|97.9|||||TWO_SIDED|90.0|84.84|112.97|||||Ratio of parameter means (Antizol/placebo, expressed as a percent), transformed back to the linear scale. 90% confidence interval for ratio of parameter means (expressed as a percent), transformed back to the linear scale.|Analyses for Cohort 3 where all available data were included.||112.97|84.84|
72449896|NCT05828017|144418567|SUPERIORITY||Mean Difference (Final Values)|1.107|||<|0.001|TWO_SIDED||||||Chi-squared|||This is to see if there is a difference in mean preference counts per participant between the standard curve, variation #1, and no preference counts.||||<0.001
72449897|NCT05828017|144418567|SUPERIORITY||Mean Difference (Final Values)|0.544||||0.015|TWO_SIDED||||||Chi-squared|||This is to see if there is a difference between Variation #1 and the standard curve in terms of mean preference counts per participant.||||0.015
72449898|NCT05828017|144418568|SUPERIORITY||Mean Difference (Final Values)|1.039|||<|0.001|TWO_SIDED||||||Chi-squared|||This is to see if there is a difference in mean preference counts per participant between the standard curve, variation #1, and no preference counts.||||<0.001
72449899|NCT05828017|144418568|SUPERIORITY||Mean Difference (Final Values)|0.47||||0.03569|TWO_SIDED||||||Chi-squared|||This is to see if there is a difference in mean preference counts between the standard curve and variation #1.||||0.03569
72449900|NCT05828017|144418569|SUPERIORITY||Mean Difference (Final Values)|0.365||||0.069|TWO_SIDED||||||Chi-squared|||This is to see if there is a difference in mean preference counts per participant between the standard curve, variation #1, and no preference counts.||||0.069
72449901|NCT05828017|144418569|SUPERIORITY||Mean Difference (Final Values)|0.087||||0.6976|TWO_SIDED||||||Chi-squared|||This is to see if there is a difference in mean preference counts between the standard curve and variation #1.||||0.6976
72498927|NCT01032629|144528161|OTHER||Difference of Least Square Mean|0.23|STANDARD_ERROR_OF_MEAN|0.039|||TWO_SIDED|95.0|0.152|0.307||||||Statistical analysis (Cholesterol) Comparison for canagliflozin versus placebo is reported here.||0.307|0.152|
72370339|NCT01388335|144251144|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|1.98|||||TWO_SIDED|90.0|0.76|3.5|||||Median Difference (Final Values) is for S-warfarin.|||3.50|0.76|
72449902|NCT05828017|144418570|SUPERIORITY||Mean Difference (Final Values)|0.876|||<|0.001|TWO_SIDED||||||Chi-squared|||This is to see if there is a difference in mean preference counts per participant between the standard curve, variation #1, and no preference counts.||||<0.001
72449903|NCT05828017|144418570|SUPERIORITY||Mean Difference (Final Values)|0.728||||0.0013|TWO_SIDED||||||Chi-squared|||This is to see if there is a difference in mean preference counts between the standard curve and variation #1.||||0.0013
72449904|NCT05828017|144418571|SUPERIORITY||Mean Difference (Final Values)|0.18||||0.522|TWO_SIDED||||||Chi-squared|||This is to see if there is a difference in mean counts per participant between the standard curve, variation #1, and no preference counts.||||0.522
72449905|NCT05828017|144418571|SUPERIORITY||Mean Difference (Final Values)|0.24||||0.27|TWO_SIDED||||||Chi-squared|||This is to see if there is a difference in mean counts between the standard curve and variation #1.||||0.27
72449906|NCT05828017|144418572|SUPERIORITY||Mean Difference (Final Values)|0.25||||0.28|TWO_SIDED||||||Chi-squared|||This is to see if there is a difference in mean counts per participant between the standard curve, variation #1, and no preference counts.||||0.28
72449907|NCT05828017|144418572|SUPERIORITY||Mean Difference (Final Values)|0.35||||0.11|TWO_SIDED||||||Chi-squared|||This is to see if there is a difference in mean counts per participant between the standard curve and variation #1.||||0.11
72449908|NCT05828017|144418573|SUPERIORITY||Mean Difference (Final Values)|0.18||||0.52|TWO_SIDED||||||Chi-squared|||This is to see if there is a difference in mean counts per participant between the standard curve, variation #1, and no preference counts.||||0.52
72498928|NCT01032629|144528161|OTHER||Difference of Least Square Mean|0.05|STANDARD_ERROR_OF_MEAN|0.009|||TWO_SIDED|95.0|0.031|0.065||||||Statistical analysis (HDL-C)||0.065|0.031|
72619587|NCT02070380|144770023|SUPERIORITY_OR_OTHER||∆Percentage MH better minus DM better|-2.1||||0.7297|TWO_SIDED|95.0|-13.8|9.6||Only 1 primary endpoint, no adjustment for multiple comparisons and the a priori threshold for statistical significance was 0.05.|Wilcoxon signed rank test||Difference in percentage MultiHance better minus percentage Dotarem better (%) , 2-sided 95% confidence interval was estimated using Altman's general approximate normal method.|"Null hypotheses:~A 0.05 mmol/kg dose of MULTIHANCE is equal to a 0.1 mmol/kg dose of DOTAREM, in terms of the assessment of global diagnostic preference in an off-site pre-dose plus post-dose paired global assessment."||9.6|-13.8|0.7297
72449909|NCT05828017|144418573|SUPERIORITY||Mean Difference (Final Values)|0.25||||0.26|TWO_SIDED||||||Chi-squared|||This is to see if there is a difference in mean counts per participant between the standard curve and variation #1.||||0.26
72449910|NCT05828017|144418574|SUPERIORITY||Mean Difference (Final Values)|0.3||||0.16|TWO_SIDED||||||Chi-squared|||This is to see if there is a difference in mean counts per participant between the standard curve, variation #1, and no preference counts.||||0.16
72449911|NCT05828017|144418574|SUPERIORITY||Mean Difference (Final Values)|0.19||||0.37|TWO_SIDED||||||Chi-squared|||This is to see if there is a difference in mean counts per participant between the standard curve and variation #1.||||0.37
72449912|NCT05828017|144418575|SUPERIORITY||Mean Difference (Final Values)|0.35||||0.08|TWO_SIDED||||||Chi-squared|||This is to see if there is a difference in mean counts per participant between the standard curve, variation #1, and no preference counts.||||0.08
72449913|NCT05828017|144418575|SUPERIORITY||Mean Difference (Final Values)|0.22||||0.31|TWO_SIDED||||||Chi-squared|||This is to see if there is a difference in mean counts per participant between the standard curve and variation #1.||||0.31
72449914|NCT05828017|144418576|SUPERIORITY||Mean Difference (Final Values)|0.27||||0.21|TWO_SIDED||||||Chi-squared|||This is to see if there is a difference in mean counts per participant between the standard curve, variation #1, and no preference counts.||||0.21
72449915|NCT05828017|144418576|SUPERIORITY||Mean Difference (Final Values)|0.38||||0.085|TWO_SIDED||||||Chi-squared|||This is to see if there is a difference in mean counts per participant between the standard curve and variation #1.||||0.085
72449916|NCT05828017|144418577|SUPERIORITY||Mean Difference (Final Values)|0.08||||0.86|TWO_SIDED||||||Chi-squared|||This is to see if there is a difference in mean counts per participant between the standard curve, variation #1, and no preference counts.||||0.86
72449917|NCT05828017|144418577|SUPERIORITY||Mean Difference (Final Values)|0.0||||1|TWO_SIDED||||||Chi-squared|||This is to see if there is a difference in mean counts per participant between the standard curve and variation #1.||||1
72449918|NCT05828017|144418578|SUPERIORITY||Mean Difference (Final Values)|0.607||||0.009|TWO_SIDED||||||Chi-squared|||This is to see if there is a difference in mean counts per participant between the standard curve, variation #1, and no preference counts.||||0.009
72449919|NCT05828017|144418578|SUPERIORITY||Mean Difference (Final Values)|0.3||||0.61|TWO_SIDED||||||Chi-squared|||This is to see if there is a difference in mean counts per participant between the standard curve and variation #1.||||0.61
72449920|NCT05828017|144418579|SUPERIORITY||Mean Difference (Final Values)|0.28|||<|0.001|TWO_SIDED|95.0|0.11|1.0|||ANOVA|||This is to see if there is a difference in mean SRT50 scores between the standard curve, variation #1, and no preference counts.||1.00|0.11|<0.001
72449921|NCT05828017|144418579|SUPERIORITY||Mean Difference (Final Values)|0.02||||0.357|TWO_SIDED|95.0|0.0|1.0|||ANOVA|||This is to see if there is a difference in SRT 50 scores between the standard curve and variation #1.||1|0|0.357
72449922|NCT05828017|144418580|SUPERIORITY||Total Count - Cramer's V|0.7|||<|0.01|TWO_SIDED||||||Chi-squared|||This is to see if there is a difference in most preferred program counts between variations #2, #3, and #4||||<0.01
72449923|NCT05828017|144418580|SUPERIORITY||Total Count - Cramer's V|0.01||||0.94|TWO_SIDED||||||Chi-squared|||This is to see if there is a difference in most preferred program counts between variations #2 and #3.||||0.94
72449924|NCT05828017|144418580|SUPERIORITY||Total Count - Cramer's V|0.014||||0.94|TWO_SIDED||||||Chi-squared|||This is to see if there is a difference in most preferred program counts between variations #2 and #4||||0.94
72449925|NCT05828017|144418580|SUPERIORITY||Total Count - Cramer's V|0.45||||0.017|TWO_SIDED||||||Chi-squared|||This is to see if there is a difference in somewhat preferred (i.e. rated in the middle) program counts between variations #2, #3, and #4||||0.017
72449926|NCT05828017|144418580|SUPERIORITY||Total Count - Cramer's V|0.51||||0.02|TWO_SIDED||||||Chi-squared|||This is to see if there is a difference in somewhat preferred (i.e. rated in the middle) program counts between variations #2 and #3.||||0.02
72449927|NCT05828017|144418580|SUPERIORITY||Total Count - Cramer's V|0.61||||0.006|TWO_SIDED||||||Chi-squared|||This is to see if there is a difference in somewhat preferred (i.e. rated in the middle) program counts between variations #2 and #4||||0.006
72449928|NCT05828017|144418580|SUPERIORITY||Total Count - Cramer's V|0.6|||<|0.0001|TWO_SIDED||||||Chi-squared|||This is to see if there is a difference in the least preferred program counts between variations #2, #3, and #4||||<.0001
72449929|NCT05828017|144418580|SUPERIORITY||Total Count - Cramer's V|0.38||||0.08|TWO_SIDED||||||Chi-squared|||This is to see if there is a difference in the least preferred program counts between variations #2 and #3||||0.08
72449930|NCT05828017|144418580|SUPERIORITY||Total Count - Cramer's V|0.5|||<|0.001|TWO_SIDED||||||Chi-squared|||This is to see if there is a difference in the least preferred program counts between variations #2 and #4||||<0.001
72449931|NCT05012163|144418581|SUPERIORITY|||||||0.506||||||Pairwise comparisons between patients offered scratch-off tickets for vaccination and those in other arms (Analyses 1, 2 and 3) were analyzed in the same regression.|Regression, Linear|||Null hypothesis: There is no difference in vaccination rates between patients sent messages offering a scratch-off lottery ticket and patients sent messages offering $1 cash in exchange for vaccination; Alternative hypothesis: the vaccination rate is higher in patients sent messages offering scratch-off tickets compared to those sent messages offering $1 cash.||||.506
72469685|NCT03635086|144463054|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|3.3||||0.2563|TWO_SIDED|95.0|0.6|17.1|||ANOVA|||Day 182||17.1|0.6|0.2563
72469686|NCT03635086|144463054|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|0.6||||0.9237|TWO_SIDED|95.0|0.1|3.3|||ANOVA|||Day 182||3.3|0.1|0.9237
72619588|NCT02070380|144770024|SUPERIORITY_OR_OTHER||||||<|0.0001||||||The priori threshold for statistical significance was 0.05.|Wilcoxon signed-rank test|||"This is a secondary analysis.~Null hypotheses:~A 0.1 mmol/kg dose of MULTIHANCE is equal to a 0.1 mmol/kg dose of DOTAREM, in terms of the assessment of Lesion Border Delineation in an off-site pre-dose plus postdose paired global assessment."||||<0.0001
72449932|NCT05012163|144418581|SUPERIORITY|||||||0.378||||||Comments: Pairwise comparisons between patients offered scratch-off tickets for vaccination and those in other arms (Analyses 1, 2 and 3) were analyzed in the same regression.|Regression, Linear|||Null hypothesis: There is no difference in vaccination rates between patients sent messages offering a scratch-off lottery ticket in exchange for vaccination and those sent active control messages; Alternative hypothesis: the vaccination rate is higher in patients sent messages offering scratch-off tickets compared to those sent active control messages.||||0.378
72449933|NCT05012163|144418581|SUPERIORITY||||||<|0.001||||||Pairwise comparisons between patients offered scratch-off tickets for vaccination and those in other arms (Analyses 1, 2 and 3) were analyzed in the same regression.|Regression, Linear|||Null hypothesis: There is no difference in vaccination rates between patients sent messages offering a scratch-off lottery ticket in exchange for vaccination and those sent no study messages; Alternative hypothesis: the vaccination rate is higher in patients sent messages offering scratch-off tickets compared to those who were not sent messages.||||<.001
72449934|NCT05012163|144418581|SUPERIORITY||||||<|0.001|||||||Regression, Linear|||Null hypothesis: There is no difference in vaccination rates between patients sent active control messages and those sent no study messages; Alternative hypothesis: the vaccination rate is higher in patients sent active control messages compared to those who were not sent messages.||||<.001
72449935|NCT05012163|144418581|SUPERIORITY|Pairwise comparisons between patients offered cash for vaccination and those in active or passive control (Analyses 5 and 6) were analyzed in the same regression.||||||0.121|||||||Regression, Linear|||Null hypothesis: There is no difference in vaccination rates between patients sent messages offering $1 cash in exchange for vaccination and those sent active control messages; Alternative hypothesis: the vaccination rate is higher in patients sent messages offering $1 cash compared to those sent active control messages.||||.121
72449936|NCT05012163|144418581|SUPERIORITY|||||||0.002||||||Pairwise comparisons between patients offered cash for vaccination and those in active or passive control (Analyses 5 and 6) were analyzed in the same regression.|Regression, Linear|||Null hypothesis: There is no difference in vaccination rates between patients sent messages offering $1 cash in exchange for vaccination and those sent no study messages; Alternative hypothesis: the vaccination rate is higher in patients sent messages offering $1 cash compared to those who were not sent messages.||||.002
72449937|NCT04070573|144418598|SUPERIORITY||Risk Difference (RD)|0.035||||0.28|TWO_SIDED||||||Chi-squared||Risk difference direction = 81mg arm minus 162mg arm.|||||0.28
72449938|NCT04070573|144418599|SUPERIORITY||Risk Difference (RD)|0.035||||0.31|TWO_SIDED||||||Chi-squared||Risk difference direction = 81mg arm minus 162mg arm.|||||0.31
72449939|NCT04070573|144418600|SUPERIORITY||Risk Difference (RD)|0.019||||0.61|TWO_SIDED||||||Chi-squared||Risk difference direction = 81mg arm minus 162mg arm.|||||0.61
72449940|NCT04070573|144418603|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.72|TWO_SIDED||||||t-test, 2 sided|||||||0.72
72449941|NCT03213873|144418664|SUPERIORITY||Interaction effect time x group|0.4||||0.57|TWO_SIDED|95.0|-1.0|1.9|||Mixed Models Analysis|||||1.9|-1.0|0.57
72449942|NCT03213873|144418665|SUPERIORITY||Interaction effect time x group|0.05||||0.25|TWO_SIDED|95.0|-0.03|0.12|||Mixed Models Analysis|||||0.12|-0.03|0.25
72449943|NCT03213873|144418666|SUPERIORITY||Interaction effect time x group|0.2||||0.75|TWO_SIDED|95.0|-0.8|1.1|||Mixed Models Analysis|||||1.1|-0.8|0.75
72449944|NCT02361216|144418677|SUPERIORITY_OR_OTHER_LEGACY||Ratio of clearance rates|6.29|||<|0.001|TWO_SIDED|95.0|2.82|14.0|||Cochran-Mantel-Haenszel|||AKclear100 at Week 8: full analysis set. The null hypothesis was that there is no difference at Week 8 in AKclear100 rates between ingenol mebutate gel 0.027% and vehicle gel. This hypothesis was tested against the 2-sided alternative of a difference between the 2 treatment groups.||14|2.82|<0.001
72449945|NCT02361216|144418678|SUPERIORITY||Ratio of clearance rates|6.81|||<|0.001|TWO_SIDED|95.0|4.16|11.1|||Cochran-Mantel-Haenszel||Mantel-Haenszel estimate (0.027% relative to vehicle), adjusted for pooled sites|The p-values for secondary endpoints have been corrected by the Holm-Bonferroni method to account for multiplicity. The prespecified multiplicity adjustment by the Holm-Bonferroni method requires the ordering of the p-values for the secondary endpoints by size.||11.1|4.16|<0.001
72449946|NCT02361216|144418679|SUPERIORITY_OR_OTHER_LEGACY||Ratio of clearance rates|6.53|||<|0.001|TWO_SIDED|95.0|4.04|10.5|||Mantel Haenszel|||The p-values for secondary endpoints have been corrected by the Holm-Bonferroni method to account for multiplicity. The pre-specified multiplicity adjustment by the Holm-Bonferroni method requires the ordering of the p-values for the secondary endpoints by size.||10.5|4.04|<0.001
72449947|NCT02361216|144418680|SUPERIORITY_OR_OTHER_LEGACY||Ratio of clearance|0.28|||<|0.001|TWO_SIDED|95.0|0.24|0.32||Negative binominal regression with log baseline count as offset variable and treatment group, anatomical location stratum and pooled site as factors.|Cochran-Mantel-Haenszel|||The p-values for secondary endpoints have been corrected by the Holm-Bonferroni method to account for multiplicity. The prespecified multiplicity adjustment by the Holm-Bonferroni method requires the ordering of the p-values for the secondary endpoints by size.||0.32|0.24|<0.001
72449948|NCT01866163|144418688|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|30.27|||<|0.001|TWO_SIDED|95.0|9.72|94.3|||Mantel Haenszel|||Multiple imputations were used to handle missing data.||94.30|9.72|<0.001
72449949|NCT01866163|144418689|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.28|||<|0.001|TWO_SIDED|95.0|-3.9|-2.67|||ANOVA|||The mean value and CIs were adjusted for the effect of pooled centres and baseline m-PASI. Multiple imputation was used to handle missing data.||-2.67|-3.90|<0.001
72449950|NCT01866163|144418690|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.27|||<|0.001|TWO_SIDED|95.0|-1.76|-0.78|||ANOVA|||The mean value and CIs were adjusted for the effect of pooled centres and baseline m-PASI. Multiple imputation was used to handle missing data.||-0.78|-1.76|<0.001
72449951|NCT02575950|144418744|SUPERIORITY||Mean Difference (Final Values)|-9.34|||<|0.001|TWO_SIDED|95.0|-14.71|-3.96|||ANCOVA|||Least square mean values and difference is from ANCOVA model with treatment as fixed effect and baseline total lesion count as covariate and participants as random effect. 100 simulations of monotone multiple imputation is performed. Summary statistics are found across these 100 simulations.||-3.96|-14.71|<.001
72370340|NCT01388335|144251144|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|2.5|||||TWO_SIDED|90.0|-1.0|6.84|||||Median Difference (Final Values) is for R-warfarin.|||6.84|-1.00|
72449952|NCT01960452|144418840|OTHER|Group comparison, for absolute (spatially z-score normalized across all electrodes for each subject)||||||0.2791|||||||t-test, 2 sided|||Only reporting values for approximate 10-20 channel CP1||||0.2791
72449953|NCT01960452|144418840|OTHER|Group comparison, for absolute multiple comparisons correction across electrodes using threshold free cluster enhancement (TFCE)||||||0.9|||||||t-test, 2 sided|||||||0.9
72449954|NCT01960452|144418841|OTHER|Group comparison, for both absolute (spatially z-score normalized across all electrodes for each subject)||||||0.1069|||||||t-test, 2 sided|||Only reporting values for approximate 10-20 channel CP1||||0.1069
72449955|NCT01960452|144418841|OTHER|Group comparison, for absolute multiple comparisons correction across electrodes using threshold free cluster enhancement (TFCE)||||||0.546|||||||t-test, 2 sided|||||||0.546
72449956|NCT01960452|144418842|OTHER|Group comparison, for absolute (spatially z-score normalized across all electrodes for each subject)||||||0.2918|||||||t-test, 2 sided|||Only reporting values for approximate 10-20 channel CP1||||0.2918
72449957|NCT01960452|144418842|OTHER|Group comparison, for absolute multiple comparisons correction across electrodes using threshold free cluster enhancement (TFCE)||||||0.761|||||||t-test, 2 sided|||||||0.761
72449958|NCT03655028|144418902|SUPERIORITY|||||||0.85||||||The co-variate used in the analysis was the 6 minute walk distance at baseline.|ANCOVA|||||||0.85
72449959|NCT03655028|144418903|SUPERIORITY|||||||0.307||||||The co-variant used to adjust the ANCOVA was the baseline step count/day.|ANCOVA|||||||.307
72449960|NCT03655028|144418904|SUPERIORITY|||||||0.106||||||this comparison is made between distance walked during 6MW at 12 weeks and distance walked during 6MW at 24 weeks|ANCOVA|||||||0.106
72449961|NCT03655028|144418905|SUPERIORITY|||||||0.26||||||Baseline PCS score was used at the co-variate|ANCOVA|||||||0.26
72449962|NCT03655028|144418906|SUPERIORITY|||||||0.85||||||Covariate was baseline MCS score|ANCOVA|||||||0.85
72449963|NCT03655028|144418907|SUPERIORITY|||||||0.025|||||||t-test, 2 sided|||||||0.025
72449964|NCT05256654|144418921|SUPERIORITY||Mean Difference (Net)|-2.8|STANDARD_ERROR_OF_MEAN|6.92||0.691|TWO_SIDED|95.0|-15.5|11.9|||Mixed Models Analysis||Model uses log-transformed outcome and baseline variables, including terms for baseline, strata (Triglycerides (TG) \<250 milligram per deciliter (mg/dL) or \>=250 mg/dL at screening), and the interaction between treatment and time.|||11.9|-15.5|0.691
72370341|NCT01388335|144251145|SUPERIORITY_OR_OTHER_LEGACY||Ratio|1.28|||||TWO_SIDED|90.0|1.14|1.44|||||Ratio of Geometric LS mean is for S-warfarin.|||1.44|1.14|
72449965|NCT05256654|144418921|SUPERIORITY||Mean Difference (Net)|-14.3|STANDARD_ERROR_OF_MEAN|4.98||0.008|TWO_SIDED|95.0|-23.6|-3.9|||Mixed Models Analysis||Model uses log-transformed outcome and baseline variables, including terms for baseline, strata (TG \<250 mg/dL or \>=250 mg/dL at screening), and the interaction between treatment and time.|||-3.9|-23.6|0.008
72449966|NCT05256654|144418921|SUPERIORITY||Mean Difference (Net)|-8.3|STANDARD_ERROR_OF_MEAN|5.36||0.14|TWO_SIDED|95.0|-18.3|2.9|||Mixed Models Analysis||Model uses log-transformed outcome and baseline variables, including terms for baseline, strata (TG \<250 mg/dL or \>=250 mg/dL at screening), and the interaction between treatment and time.|||2.9|-18.3|0.140
72449967|NCT05256654|144418922|SUPERIORITY||Mean Difference (Net)|-54.3|STANDARD_ERROR_OF_MEAN|5.08|<|0.001|TWO_SIDED|95.0|-63.3|-43.1|||Mixed Models Analysis||Model uses log-transformed outcome and baseline variables, including terms for baseline, strata (TG \<250 mg/dL or \>=250 mg/dL at screening), and the interaction between treatment and time.|||-43.1|-63.3|<.001
72449968|NCT05256654|144418922|SUPERIORITY||Mean Difference (Net)|-69.8|STANDARD_ERROR_OF_MEAN|2.73|<|0.001|TWO_SIDED|95.0|-74.8|-63.9|||Mixed Models Analysis||Model uses log-transformed outcome and baseline variables, including terms for baseline, strata (TG \<250 mg/dL or \>=250 mg/dL at screening), and the interaction between treatment and time.|||-63.9|-74.8|<.001
72449969|NCT05256654|144418922|SUPERIORITY||Mean Difference (Net)|-76.6|STANDARD_ERROR_OF_MEAN|2.13|<|0.001|TWO_SIDED|95.0|-80.4|-72.0|||Mixed Models Analysis||Model uses log-transformed outcome and baseline variables, including terms for baseline, strata (TG \<250 mg/dL or \>=250 mg/dL at screening), and the interaction between treatment and time.|||-72.0|-80.4|<.001
72449970|NCT05256654|144418923|SUPERIORITY||Mean Difference (Net)|-1.3|STANDARD_ERROR_OF_MEAN|7.24||0.854|TWO_SIDED|95.0|-14.6|14.0|||Mixed Models Analysis||Model uses log-transformed outcome and baseline variables, including terms for baseline, strata (TG \<250 mg/dL or \>=250 mg/dL at screening), and the interaction between treatment and time.|||14.0|-14.6|0.854
72449971|NCT05256654|144418923|SUPERIORITY||Mean Difference (Net)|-16.8|STANDARD_ERROR_OF_MEAN|4.98||0.002|TWO_SIDED|95.0|-26.0|-6.4|||Mixed Models Analysis||Model uses log-transformed outcome and baseline variables, including terms for baseline, strata (TG \<250 mg/dL or \>=250 mg/dL at screening), and the interaction between treatment and time.|||-6.4|-26.0|0.002
72449972|NCT05256654|144418923|SUPERIORITY||Mean Difference (Net)|-12.1|STANDARD_ERROR_OF_MEAN|5.28||0.033|TWO_SIDED|95.0|-21.9|-1.1|||Mixed Models Analysis||Model uses log-transformed outcome and baseline variables, including terms for baseline, strata (TG \<250 mg/dL or \>=250 mg/dL at screening), and the interaction between treatment and time.|||-1.1|-21.9|0.033
72449973|NCT05256654|144418924|SUPERIORITY||Mean Difference (Net)|-6.1|STANDARD_ERROR_OF_MEAN|4.03||0.143|TWO_SIDED|95.0|-13.8|2.2|||Mixed Models Analysis||Model uses log-transformed outcome and baseline variables, including terms for baseline, strata (TG \<250 mg/dL or \>=250 mg/dL at screening), and the interaction between treatment and time.|||2.2|-13.8|0.143
72449974|NCT05256654|144418924|SUPERIORITY||Mean Difference (Net)|-16.4|STANDARD_ERROR_OF_MEAN|2.93|<|0.001|TWO_SIDED|95.0|-22.0|-10.5|||Mixed Models Analysis||Model uses log-transformed outcome and baseline variables, including terms for baseline, strata (TG \<250 mg/dL or \>=250 mg/dL at screening), and the interaction between treatment and time.|||-10.5|-22.0|<.001
72449975|NCT05256654|144418924|SUPERIORITY||Mean Difference (Net)|-22.7|STANDARD_ERROR_OF_MEAN|2.71|<|0.001|TWO_SIDED|95.0|-27.9|-17.2|||Mixed Models Analysis||Model uses log-transformed outcome and baseline variables, including terms for baseline, strata (TG \<250 mg/dL or \>=250 mg/dL at screening), and the interaction between treatment and time.|||-17.2|-27.9|<.001
72449976|NCT05256654|144418925|SUPERIORITY||Mean Difference (Net)|-10.8|STANDARD_ERROR_OF_MEAN|5.55||0.068|TWO_SIDED|95.0|-21.1|0.9|||Mixed Models Analysis||Model uses log-transformed outcome and baseline variables, including terms for baseline, strata (TG \<250 mg/dL or \>=250 mg/dL at screening), and the interaction between treatment and time.|||0.9|-21.1|0.068
72449977|NCT05256654|144418925|SUPERIORITY||Mean Difference (Net)|-25.5|STANDARD_ERROR_OF_MEAN|3.79|<|0.001|TWO_SIDED|95.0|-32.6|-17.6|||Mixed Models Analysis||Model uses log-transformed outcome and baseline variables, including terms for baseline, strata (TG \<250 mg/dL or \>=250 mg/dL at screening), and the interaction between treatment and time.|||-17.6|-32.6|<.001
72449978|NCT05256654|144418925|SUPERIORITY||Mean Difference (Net)|-23.8|STANDARD_ERROR_OF_MEAN|3.88|<|0.001|TWO_SIDED|95.0|-31.1|-15.7|||Mixed Models Analysis||Model uses log-transformed outcome and baseline variables, including terms for baseline, strata (TG \<250 mg/dL or \>=250 mg/dL at screening), and the interaction between treatment and time.|||-15.7|-31.1|<.001
72449979|NCT05256654|144418926|SUPERIORITY||Mean Difference (Net)|-36.3|STANDARD_ERROR_OF_MEAN|5.21|<|0.001|TWO_SIDED|95.0|-45.8|-25.1|||Mixed Models Analysis||Model uses log-transformed outcome and baseline variables, including terms for baseline, strata (TG \<250 mg/dL or \>=250 mg/dL at screening), and the interaction between treatment and time.|||-25.1|-45.8|<.001
72449980|NCT05256654|144418926|SUPERIORITY||Mean Difference (Net)|-50.3|STANDARD_ERROR_OF_MEAN|3.31|<|0.001|TWO_SIDED|95.0|-56.4|-43.3|||Mixed Models Analysis||Model uses log-transformed outcome and baseline variables, including terms for baseline, strata (TG \<250 mg/dL or \>=250 mg/dL at screening), and the interaction between treatment and time.|||-43.3|-56.4|<.001
72449981|NCT05256654|144418926|SUPERIORITY||Mean Difference (Net)|-52.5|STANDARD_ERROR_OF_MEAN|3.17|<|0.001|TWO_SIDED|95.0|-58.4|-45.9|||Mixed Models Analysis||Model uses log-transformed outcome and baseline variables, including terms for baseline, strata (TG \<250 mg/dL or \>=250 mg/dL at screening), and the interaction between treatment and time.|||-45.9|-58.4|<.001
72449982|NCT05256654|144418927|SUPERIORITY||Mean Difference (Net)|-38.6|STANDARD_ERROR_OF_MEAN|7.76|<|0.001|TWO_SIDED|95.0|-52.2|-21.2|||Mixed Models Analysis||Model uses log-transformed outcome and baseline variables, including terms for baseline, strata (TG \<250 mg/dL or \>=250 mg/dL at screening), and the interaction between treatment and time.|||-21.2|-52.2|<.001
72449983|NCT05256654|144418927|SUPERIORITY||Mean Difference (Net)|-54.0|STANDARD_ERROR_OF_MEAN|4.69|<|0.001|TWO_SIDED|95.0|-62.4|-43.8|||Mixed Models Analysis||Model uses log-transformed outcome and baseline variables, including terms for baseline, strata (TG \<250 mg/dL or \>=250 mg/dL at screening), and the interaction between treatment and time.|||-43.8|-62.4|<.001
72449984|NCT05256654|144418927|SUPERIORITY||Mean Difference (Net)|-63.6|STANDARD_ERROR_OF_MEAN|3.72|<|0.001|TWO_SIDED|95.0|-70.3|55.5|||Mixed Models Analysis||Model uses log-transformed outcome and baseline variables, including terms for baseline, strata (TG \<250 mg/dL or \>=250 mg/dL at screening), and the interaction between treatment and time.|||55.5|-70.3|<.001
72449985|NCT05256654|144418928|SUPERIORITY||Mean Difference (Net)|-4.1|STANDARD_ERROR_OF_MEAN|5.99||0.506|TWO_SIDED|95.0|-15.2|8.5|||Mixed Models Analysis||Model uses log-transformed outcome and baseline variables, including terms for baseline, strata (TG \<250 mg/dL or \>=250 mg/dL at screening), and the interaction between treatment and time.|||8.5|-15.2|0.506
72449986|NCT05256654|144418928|SUPERIORITY||Mean Difference (Net)|-19.7|STANDARD_ERROR_OF_MEAN|4.04|<|0.001|TWO_SIDED|95.0|-27.2|-11.3|||Mixed Models Analysis||Model uses log-transformed outcome and baseline variables, including terms for baseline, strata (TG \<250 mg/dL or \>=250 mg/dL at screening), and the interaction between treatment and time.|||-11.3|-27.2|<.001
72449987|NCT05256654|144418928|SUPERIORITY||Mean Difference (Net)|-19.4|STANDARD_ERROR_OF_MEAN|4.06|<|0.001|TWO_SIDED|95.0|-27.0|-11.0|||Mixed Models Analysis||Model uses log-transformed outcome and baseline variables, including terms for baseline, strata (TG \<250 mg/dL or \>=250 mg/dL at screening), and the interaction between treatment and time.|||-11.0|-27.0|<.001
72449988|NCT05256654|144418929|SUPERIORITY||Mean Difference (Net)|-3.4|STANDARD_ERROR_OF_MEAN|4.16||0.428|TWO_SIDED|95.0|-11.2|5.2|||Mixed Models Analysis||Model uses log-transformed outcome and baseline variables, including terms for baseline, strata (TG \<250 mg/dL or \>=250 mg/dL at screening), and the interaction between treatment and time.|||5.2|-11.2|0.428
72449989|NCT05256654|144418929|SUPERIORITY||Mean Difference (Net)|-8.7|STANDARD_ERROR_OF_MEAN|3.14||0.009|TWO_SIDED|95.0|-14.7|-2.3|||Mixed Models Analysis||Model uses log-transformed outcome and baseline variables, including terms for baseline, strata (TG \<250 mg/dL or \>=250 mg/dL at screening), and the interaction between treatment and time.|||-2.3|-14.7|0.009
72449990|NCT05256654|144418929|SUPERIORITY||Mean Difference (Net)|-12.2|STANDARD_ERROR_OF_MEAN|3.04|<|0.001|TWO_SIDED|95.0|-18.0|-6.0|||Mixed Models Analysis||Model uses log-transformed outcome and baseline variables, including terms for baseline, strata (TG \<250 mg/dL or \>=250 mg/dL at screening), and the interaction between treatment and time.|||-6.0|-18.0|<.001
72449991|NCT05256654|144418930|SUPERIORITY||Mean Difference (Net)|6.5|STANDARD_ERROR_OF_MEAN|8.1||0.412|TWO_SIDED|95.0|-8.4|23.7|||Mixed Models Analysis||Model uses log-transformed outcome and baseline variables, including terms for baseline, strata (TG \<250 mg/dL or \>=250 mg/dL at screening), and the interaction between treatment and time.|||23.7|-8.4|0.412
72370342|NCT01388335|144251145|SUPERIORITY_OR_OTHER_LEGACY||Ratio|1.26|||||TWO_SIDED|90.0|1.08|1.47|||||Ratio of Geometric LS mean is for R-warfarin.|||1.47|1.08|
72449992|NCT05256654|144418930|SUPERIORITY||Mean Difference (Net)|-9.5|STANDARD_ERROR_OF_MEAN|5.52||0.104|TWO_SIDED|95.0|-19.7|2.1|||Mixed Models Analysis||Model uses log-transformed outcome and baseline variables, including terms for baseline, strata (TG \<250 mg/dL or \>=250 mg/dL at screening), and the interaction between treatment and time.|||2.1|-19.7|0.104
72370343|NCT01388335|144251150|SUPERIORITY_OR_OTHER_LEGACY||Ratio|0.92|||||TWO_SIDED|90.0|0.86|1.0|||||Ratio of Geometric LS mean.|||1.00|0.86|
72449993|NCT05256654|144418930|SUPERIORITY||Mean Difference (Net)|-5.4|STANDARD_ERROR_OF_MEAN|5.79||0.363|TWO_SIDED|95.0|-16.2|6.7|||Mixed Models Analysis||Model uses log-transformed outcome and baseline variables, including terms for baseline, strata (TG \<250 mg/dL or \>=250 mg/dL at screening), and the interaction between treatment and time.|||6.7|-16.2|0.363
72469687|NCT03635086|144463054|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|2.0||||0.7708|TWO_SIDED|95.0|0.4|10.8|||ANOVA|||Day 182||10.8|0.4|0.7708
72469688|NCT03635086|144463054|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|3.3||||0.2661|TWO_SIDED|95.0|0.6|16.9|||ANOVA|||Day 182||16.9|0.6|0.2661
72469689|NCT03635086|144463054|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|0.5||||0.7614|TWO_SIDED|95.0|0.1|2.6|||ANOVA|||Day 365||2.6|0.1|0.7614
72449994|NCT05256654|144418931|SUPERIORITY||Mean Difference (Net)|-10.8|STANDARD_ERROR_OF_MEAN|6.19||0.101|TWO_SIDED|95.0|-22.2|2.3|||Mixed Models Analysis||Model uses log-transformed outcome and baseline variables, including terms for baseline, strata (TG \<250 mg/dL or \>=250 mg/dL at screening), and the interaction between treatment and time.|||2.3|-22.2|0.101
72449995|NCT05256654|144418931|SUPERIORITY||Mean Difference (Net)|-11.3|STANDARD_ERROR_OF_MEAN|4.96||0.033|TWO_SIDED|95.0|-20.6|-1.0|||Mixed Models Analysis||Model uses log-transformed outcome and baseline variables, including terms for baseline, strata (TG \<250 mg/dL or \>=250 mg/dL at screening), and the interaction between treatment and time.|||-1.0|-20.6|0.033
72449996|NCT05256654|144418931|SUPERIORITY||Mean Difference (Net)|-10.9|STANDARD_ERROR_OF_MEAN|4.98||0.04|TWO_SIDED|95.0|-20.3|-0.6|||Mixed Models Analysis||Model uses log-transformed outcome and baseline variables, including terms for baseline, strata (TG \<250 mg/dL or \>=250 mg/dL at screening), and the interaction between treatment and time.|||-0.6|-20.3|0.040
72449997|NCT05256654|144418932|SUPERIORITY||Mean Difference (Net)|-28.3|STANDARD_ERROR_OF_MEAN|6.79|<|0.001|TWO_SIDED|95.0|-40.5|-13.6|||Mixed Models Analysis||Model uses log-transformed outcome and baseline variables, including terms for baseline, strata (TG \<250 mg/dL or \>=250 mg/dL at screening), and the interaction between treatment and time.|||-13.6|-40.5|<.001
72449998|NCT05256654|144418932|SUPERIORITY||Mean Difference (Net)|-42.5|STANDARD_ERROR_OF_MEAN|4.35|<|0.001|TWO_SIDED|95.0|-50.5|-33.2|||Mixed Models Analysis||Model uses log-transformed outcome and baseline variables, including terms for baseline, strata (TG \<250 mg/dL or \>=250 mg/dL at screening), and the interaction between treatment and time.|||-33.2|-50.5|<.001
72449999|NCT05256654|144418932|SUPERIORITY||Mean Difference (Net)|-44.8|STANDARD_ERROR_OF_MEAN|4.2|<|0.001|TWO_SIDED|95.0|-52.5|-35.9|||Mixed Models Analysis||Model uses log-transformed outcome and baseline variables, including terms for baseline, strata (TG \<250 mg/dL or \>=250 mg/dL at screening), and the interaction between treatment and time.|||-35.9|-52.5|<.001
72450000|NCT05167864|144418935|SUPERIORITY|||||||0.13519|TWO_SIDED|95.0|||||Wilcoxon signed-rank sum test||||the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement of line in the forehead post injection day 3|||0.13519
72450001|NCT05167864|144418935|SUPERIORITY|||||||0.8556|TWO_SIDED|95.0|||||Wilcoxon signed-rank sum test||||the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement of line in the forehead post injection day 3|||0.8556
72450002|NCT05167864|144418935|SUPERIORITY|||||||0.46943|TWO_SIDED|95.0|||||Wilcoxon signed-rank test||||the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement of line in the forehead post injection day 3|||0.46943
72450003|NCT05167864|144418935|SUPERIORITY|||||||0.0449|TWO_SIDED|95.0|||||Wilcoxon signed-rank sum test||||the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement of line in the forehead post injection day 3|||0.0449
72450004|NCT05167864|144418935|SUPERIORITY|||||||0.504|TWO_SIDED|95.0|||||Wilcoxon signed-rank sum test||||the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement of line in the forehead post injection day 30|||0.504
72450005|NCT05167864|144418935|SUPERIORITY|||||||0.772193|TWO_SIDED|95.0|||||Wilcoxon signed-rank sum test||||the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement of line in the forehead post injection day 30|||0.772193
72450006|NCT05167864|144418935|SUPERIORITY|||||||0.5414|TWO_SIDED|95.0|||||Wilcoxon signed-rank sum test||||the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement of line in the forehead post injection day 30|||0.5414
72450007|NCT05167864|144418935|SUPERIORITY|||||||0.07|TWO_SIDED|95.0|||||Wilcoxon signed-rank sum test||||the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement of line in the forehead post injection day 30|||0.070
72370344|NCT01388335|144251151|SUPERIORITY_OR_OTHER_LEGACY||Ratio|0.98|||||TWO_SIDED|90.0|0.95|1.02|||||Ratio of Geometric LS mean.|||1.02|0.95|
72450008|NCT05167864|144418935|SUPERIORITY|||||||0.546|TWO_SIDED|95.0|||||Wilcoxon signed rank sum test||||the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement of line in the forehead post injection day 90|||0.546
72450009|NCT05167864|144418935|SUPERIORITY|||||||0.756|TWO_SIDED|95.0|||||Wilcoxon signed rank sum test||||the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement of line in the forehead post injection day 90|||0.756
72450010|NCT05167864|144418935|SUPERIORITY|||||||0.7|TWO_SIDED|95.0|||||Wilcoxon signed rank sum test||||the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement of line in the forehead post injection day 90|||0.700
72450011|NCT05167864|144418935|SUPERIORITY|||||||0.397|TWO_SIDED|95.0|||||Wilcoxon signed rank sum||||the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement of line in the forehead post injection day 90|||0.397
72450012|NCT05167864|144418935|SUPERIORITY|||||||0.093|TWO_SIDED|95.0|||||Wilcoxon signed rank sum||||the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement of line in the forehead post injection day 180|||0.093
72450013|NCT05167864|144418935|SUPERIORITY|||||||0.323|TWO_SIDED|95.0|||||Wilcoxon signed rank sum||||the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement of line in the forehead post injection day 180|||0.323
72450014|NCT05167864|144418935|SUPERIORITY|||||||0.182|TWO_SIDED|95.0|||||Wilcoxon signed rank sum||||the correlation of dynamic strain (decreased compression) tothe patient satisfaction improvement of line in the forehead post injection day 180|||0.182
72450015|NCT05167864|144418935|SUPERIORITY|||||||0.88|TWO_SIDED|95.0|||||Wilcoxon signed rank sum||||the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement of line in the forehead post injection day 180|||0.880
72450016|NCT05167864|144418935|SUPERIORITY|||||||0.496|TWO_SIDED|95.0|||||Wilcoxon signed rank sum||||the correlation of dynamic strain (decreased compression) tothe patient satisfaction improvement in the forehead post injection day 3|||0.496
72450017|NCT05167864|144418935|SUPERIORITY|||||||0.905|TWO_SIDED|95.0|||||Wilcoxon signed rank sum||||the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement in the forehead post injection day 3|||0.905
72370345|NCT01388335|144251154|SUPERIORITY_OR_OTHER_LEGACY||Ratio of Geometric LS Mean|1.03||||||90.0|0.99|1.08|||||Ratio of Geometric LS mean for Period 2, Day 14, 0 hours.|||1.08|0.99|
72450018|NCT05167864|144418935|SUPERIORITY|||||||0.692|TWO_SIDED|95.0|||||Wilcoxon signed rank sum||||the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement in the forehead post injection day 3|||0.692
72450019|NCT05167864|144418935|SUPERIORITY|||||||0.262|TWO_SIDED|95.0|||||Wilcoxon signed rank sum||||the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement in the forehead post injection day 3|||0.262
72450020|NCT05167864|144418935|SUPERIORITY|||||||0.828|TWO_SIDED|95.0|||||Wilcoxon signed rank sum||||the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement in the forehead post injection day 30|||0.828
72450021|NCT05167864|144418935|SUPERIORITY|||||||0.268|TWO_SIDED|95.0|||||Wilcoxon signed rank sum test||||the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement in the forehead post injection day 30|||0.268
72450022|NCT05167864|144418935|SUPERIORITY|||||||0.975|TWO_SIDED|95.0|||||Wilcoxon signed rank sum||||the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement in the forehead post injection day 30|||0.975
72450023|NCT05167864|144418935|SUPERIORITY|||||||0.499|TWO_SIDED|95.0|||||Wilcoxon signed rank sum||||the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement in the forehead post injection day 30|||0.499
72450024|NCT05167864|144418935|SUPERIORITY|||||||0.75|TWO_SIDED|95.0|||||Wilcoxon signed rank sum||||the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement in the forehead post injection day 90|||0.750
72450025|NCT05167864|144418935|SUPERIORITY|||||||0.433|TWO_SIDED|95.0|||||Wilcoxon signed rank sum||||the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement in the forehead post injection day 90|||0.433
72450026|NCT05167864|144418935|SUPERIORITY|||||||0.834|TWO_SIDED|95.0|||||Wilcoxon signed rank sum||||the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement in the forehead post injection day 90|||0.834
72450027|NCT05167864|144418935|SUPERIORITY|||||||0.834|TWO_SIDED|95.0|||||Wilcoxon signed rank sum||||the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement in the forehead post injection day 90|||0.834
72450028|NCT05167864|144418935|SUPERIORITY|||||||0.526|TWO_SIDED|95.0|||||Wilcoxon signed rank sum test||||the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement in the forehead post injection day 180|||0.526
72450029|NCT05167864|144418935|SUPERIORITY|||||||0.816|TWO_SIDED|95.0|||||Wilcoxon singed rank sum||||the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement in the forehead post injection day 180|||0.816
72450030|NCT05167864|144418935|SUPERIORITY|||||||0.65|TWO_SIDED|95.0|||||wilcoxon signed rank sum||||the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement in the forehead post injection day 180|||0.650
72450031|NCT05167864|144418935|SUPERIORITY|||||||0.095|TWO_SIDED|95.0|||||wilcoxon rank sum test||||the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement in the forehead post injection day 180|||0.095
72370346|NCT01388335|144251154|SUPERIORITY_OR_OTHER_LEGACY||Ratio of Geometric LS Means|1.02|||||TWO_SIDED|90.0|0.98|1.06|||||Ratio of Geometric LS mean for Period 2, Day 14, 4 hours.|||1.06|0.98|
72450032|NCT05167864|144418935|SUPERIORITY|||||||0.618|TWO_SIDED|95.0|||||Wilcoxon signed rank sum||||the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement in the lines between the eyebrows post injection day 3|||0.618
72450033|NCT05167864|144418935|SUPERIORITY|||||||0.34|TWO_SIDED|95.0|||||wilcoxon signed rank sum||||the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement in the lines between the eyebrows post injection day 3|||0.340
72450034|NCT05167864|144418935|SUPERIORITY|||||||0.15|TWO_SIDED|95.0|||||Wilcoxon signed rank sum||||the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement in the lines between the eyebrows post injection day 3|||0.150
72450035|NCT05167864|144418935|SUPERIORITY|||||||0.361|TWO_SIDED|95.0|||||Wilcoxon signed rank sum test||||the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement in the lines between the eyebrows post injection day 3|||0.361
72450036|NCT05167864|144418935|SUPERIORITY|||||||0.428|TWO_SIDED|95.0|||||wilcoxon signed rank sum||||the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement in the lines between the eyebrows post injection day 30|||0.428
72450037|NCT05167864|144418935|SUPERIORITY|||||||0.834|TWO_SIDED|95.0|||||Wilcoxon signed rank sum||||the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement in the lines between the eyebrows post injection day 30|||0.834
72450038|NCT05167864|144418935|SUPERIORITY|||||||0.318|TWO_SIDED|95.0|||||wilcoxon signed rank sum||||the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement in the lines between the eyebrows post injection day 30|||0.318
72450039|NCT05167864|144418935|SUPERIORITY|||||||0.311|TWO_SIDED|95.0|||||wilcoxon signed rank sum||||the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement in the lines between the eyebrows post injection day 30|||0.311
72450040|NCT05167864|144418935|SUPERIORITY|||||||0.885|TWO_SIDED|95.0|||||Wilcoxon signed rank sum||||the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement in the lines between the eyebrows post injection day 90|||0.885
72450041|NCT05167864|144418935|SUPERIORITY|||||||0.457|TWO_SIDED|95.0|||||Wilcoxon signed rank sum||||the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement in the lines between the eyebrows post injection day 90|||0.457
72450042|NCT05167864|144418935|SUPERIORITY|||||||0.745|TWO_SIDED|95.0|||||Wilcoxon signed rank sum||||the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement in the lines between the eyebrows post injection day 90|||0.745
72450043|NCT05167864|144418935|SUPERIORITY|||||||0.757|TWO_SIDED|95.0|||||wilcoxon signed rank sum||||the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement in the lines between the eyebrows post injection day 90|||0.757
72450044|NCT05167864|144418935|SUPERIORITY|||||||0.562|TWO_SIDED|95.0|||||wilcoxon signed rank sum||||the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement in the lines between the eyebrows post injection day 180|||0.562
72469690|NCT03635086|144463054|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|0.8||||0.9905|TWO_SIDED|95.0|0.1|4.3|||ANOVA|||Day 365||4.3|0.1|0.9905
72450045|NCT05167864|144418935|SUPERIORITY|||||||0.828|TWO_SIDED|95.0|||||wilcoxon signed rank sum||||the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement in the lines between the eyebrows post injection day 180|||0.828
72450046|NCT05167864|144418935|SUPERIORITY|||||||0.005|TWO_SIDED|95.0|||||wilcoxon signed rank sum||||the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement in the lines between the eyebrows post injection day 180|||0.005
72450047|NCT05167864|144418935|SUPERIORITY|||||||0.437|TWO_SIDED|95.0|||||wilcoxon signed rank sum||||the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement in the lines between the eyebrows post injection day 180|||0.437
72450048|NCT05207982|144418936|OTHER|||||||||||||||||This study utilized a multiple baseline single case experimental design in which analysis of the daily weights (for each participant) involved discontinuous growth curve analysis using multi-level modeling. Separate models were developed for each participant which include the daily weights from the baseline, treatment and follow-up phases. Given the nature of the data, we hypothesized different slopes for the baseline vs treatment phases. Overall weight change was a primary outcome measure.|Multiple baseline single case experimental design in which analysis of the daily weights (for each participant) involved discontinuous growth curve analysis using multi-level modeling.|||
72450049|NCT04089059|144418943|SUPERIORITY|Poisson regression for comparison of incidence rate against performance goal (0.43)|||||<|0.0001|||||||Poisson Regression|||||||<0.0001
72450050|NCT04089059|144418946|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||Comparison of HF Hospitalization events 6 months before implant vs 6 months after implant||||<0.0001
72450051|NCT04089059|144418947|SUPERIORITY|Comparison of the incidence rate of HF hospitalizations or emergency department / hospital outpatient IV diuretic visits of Former Control Arm versus Modified Intent to Treat Arm at 6 months post-implant/Subgroup Analysis||||||0.0697|||||||Poisson Regression|||||||0.0697
72450052|NCT04089059|144418950|SUPERIORITY|Comparison of mPAP values at baseline to values at 6 months.||||||0.0952|||||||Wilcoxon (Mann-Whitney)|||||||0.0952
72498929|NCT01032629|144528161|OTHER||Difference of Least Square Mean|0.06|STANDARD_ERROR_OF_MEAN|0.009|||TWO_SIDED|95.0|0.04|0.075||||||Statistical analysis (HDL-C) Comparison for canagliflozin versus placebo is reported here.||0.075|0.040|
72498930|NCT01032629|144528161|OTHER||Difference of Least Square Mean|0.11|STANDARD_ERROR_OF_MEAN|0.032|||TWO_SIDED|95.0|0.046|0.17||||||Statistical analysis (LDL-C) Comparison for canagliflozin versus placebo is reported here.||0.170|0.046|
72450053|NCT04089059|144418950|SUPERIORITY|Comparison of mPAP values at baseline to values at 6 months.||||||0.009|||||||Wilcoxon (Mann-Whitney)|||||||0.0090
72450054|NCT04089059|144418950|SUPERIORITY|Comparison of mPAP values at baseline to values at 6 months.|||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
72498931|NCT01032629|144528161|OTHER||Difference of Least Square Mean|0.16|STANDARD_ERROR_OF_MEAN|0.032|||TWO_SIDED|95.0|0.102|0.226||||||Statistical analysis (LDL-C) Comparison for canagliflozin versus placebo is reported here.||0.226|0.102|
72450055|NCT04089059|144418952|SUPERIORITY|Comparison of KCCQ at baseline and at 6 months||||||0.0026|||||||Wilcoxon (Mann-Whitney)|||||||0.0026
72450056|NCT04089059|144418953|OTHER|Test of difference in distribution of NYHA class from baseline (all patients were class III at baseline).|||||<|0.0001|||||||Chi-squared|||The New York Heart Association (NYHA) Classification is a system used to evaluate and classify the severity of heart failure based on symptoms, patient's physical activity, and quality of life. Its scale ranges from class 1 to 4 with class 1 indicating the least severe heart failure symptoms (i.e., the best functionality) and class 4 indicating the most severe heart failure symptoms (i.e., the poorest functionality), with higher classes indicating poorer functioning as relates to heart failure.||||<0.0001
72498932|NCT01032629|144528162|OTHER||Difference of Least Square Mean|0.02|STANDARD_ERROR_OF_MEAN|0.03|||TWO_SIDED|95.0|-0.04|0.076||||||||0.076|-0.040|
72370347|NCT02268175|144251155|SUPERIORITY|||||||0.151||||||1-sided|Fisher Exact|||The hypothesis was that treatment with ARM 1 will have a pCR/MRD rate of 35% compared with Arm 2 rate of 10%. Given 75 men randomized in 2:1 ratio to Arm 1 (N=50) or Arm 2 (N=25), there was 84% power to detect this difference, using Fisher's exact test with one-sided type I error of 0.1.||||0.151
72450057|NCT04089059|144418954|SUPERIORITY|Comparison of baseline 6MWT vs 6 month 6MWT.||||||0.1086|||||||Wilcoxon (Mann-Whitney)|||||||0.1086
72450058|NCT04089059|144418957|SUPERIORITY|Compare NTproBNP at baseline with 6 months||||||0.0628|||||||Wilcoxon (Mann-Whitney)|||||||0.0628
72450059|NCT03728608|144418980|SUPERIORITY|||||||0.92|||||||survival analysis|||||||0.92
72450060|NCT03728608|144418981|SUPERIORITY|||||||0.65|||||||survival analysis|||||||0.65
72450061|NCT03728608|144418982|SUPERIORITY|||||||0.96|||||||survival analysis|||||||0.96
72450062|NCT03728608|144418983|SUPERIORITY|||||||0.77|||||||survival analysis|||||||0.77
72450063|NCT03728608|144418984|SUPERIORITY|||||||0.43|||||||Regression, Logistic|||||||0.43
72450064|NCT03728608|144418985|SUPERIORITY|||||||0.97|||||||Regression, Logistic|||||||0.97
72450065|NCT03728608|144418986|SUPERIORITY|||||||0.97|||||||Regression, Logistic|||||||0.97
72450066|NCT03728608|144418987|SUPERIORITY|||||||0.79|||||||Regression, Logistic|||||||0.79
72450067|NCT01828112|144419028|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.49|||<|0.001|TWO_SIDED|95.0|0.36|0.67|||Log Rank|||||0.67|0.36|<0.001
72450068|NCT05586490|144419087|OTHER|A comparison is not being made between two different treatment groups.|Mean Difference (Net)|-0.6375||||0.429|TWO_SIDED|||||A priori threshold for statistical significance is p \< 0.05.|t-test, 2 sided|Paired samples t-test, df = 7||||||0.429
72498933|NCT01032629|144528162|OTHER||Difference of Least Square Mean|0.04|STANDARD_ERROR_OF_MEAN|0.03|||TWO_SIDED|95.0|-0.023|0.094||||||||0.094|-0.023|
72498934|NCT00348140|144528163|SUPERIORITY||Mean Difference (Net)|0.3||||0.739|TWO_SIDED|95.0|-1.2|1.8|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|||1.8|-1.2|0.739
72498935|NCT00348140|144528163|SUPERIORITY||Mean Difference (Net)|0.8||||0.343|TWO_SIDED|95.0|-0.8|2.4|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|||2.4|-0.8|0.343
72450069|NCT05586490|144419088|OTHER|A comparison is not being made between two different treatment groups.|Mean Difference (Net)|3.75||||0.351|TWO_SIDED|||||A priori threshold for statistical significance was p \< 0.05|t-test, 2 sided|Paired samples t-test, df = 7||||||0.351
72450070|NCT05586490|144419089|OTHER|A comparison is not being made between two different treatment groups.|Mean Difference (Net)|-0.013||||0.937|TWO_SIDED|||||A priori threshold for statistical significance was p \< 0.05|t-test, 2 sided|Paired samples t-test, df = 7||||||0.937
72450071|NCT05586490|144419090|OTHER|A comparison is not being made between two different treatment groups.|Mean Difference (Net)|-14.8||||0.044|TWO_SIDED|||||A priori threshold for statistical significance was p \< 0.05|t-test, 2 sided|Paired samples t-test, df = 7||||||0.044
72390918|NCT00622284|144289434|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.648||||0.0025||95.0|0.489|0.859|||Regression, Logistic|The odds ratio is treatment adjusted for baseline HbA1c and the number of previous anti-diabetic medications.||Linagliptin versus Glimepiride||0.859|0.489|0.0025
72390919|NCT00622284|144289435|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.689||||0.024||95.0|0.498|0.952|||Regression, Logistic|The odds ratio is treatment adjusted for baseline HbA1c and the number of previous anti-diabetic medications.||Linagliptin versus Glimepiride||0.952|0.498|0.0240
72390920|NCT00622284|144289436|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.7||||0.0018||95.0|0.56|0.875|||Regression, Logistic|The odds ratio is treatment adjusted for baseline HbA1c and the number of previous anti-diabetic medications.||Linagliptin versus Glimepiride||0.875|0.560|0.0018
72390921|NCT00622284|144289437|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-9.47|STANDARD_ERROR_OF_MEAN|5.77||0.0918||95.0|-21.07|1.59|||ANCOVA|||Linagliptin versus Glimepiride||1.59|-21.07|0.0918
72390922|NCT01217801|144289523|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|93.77||||0.05|TWO_SIDED|90.0|89.15|98.63|||Regression, Linear|||Linear mixed effect model, log transformed AUC, LSMeans for treatment Film and Tablet, the difference between the LSMeans and 90%CI calculated and transformed to geometric means, ratio estimates and 90%CI||98.63|89.15|0.05
72390923|NCT01552694|144289569|SUPERIORITY_OR_OTHER|||||||0.006|TWO_SIDED|||||A priori threshold for statistical significance was p\<0.05. Unadjusted p-value compares the change (week 8 - baseline) for plasma hsCRP between the 2 groups.|t-test, 2 sided|||||||0.006
72390924|NCT01552694|144289570|SUPERIORITY_OR_OTHER|||||||0.24|TWO_SIDED|||||A priori threshold for statistical significance was p\<0.05. Unadjusted analysis.|t-test, 2 sided|||||||0.24
72390925|NCT01552694|144289571|SUPERIORITY_OR_OTHER|||||||0.78|TWO_SIDED|||||A priori threshold for statistical significance was p\<0.05. Unadjusted analysis|t-test, 2 sided|||||||0.78
72390926|NCT01558271|144289596|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.57|||<|0.001|TWO_SIDED|95.0|-1.79|-1.35|||Mixed Models Analysis|||Approximately 490 participants were to be randomized in a 4:1:2 ratio to LY2189265, placebo, or Liraglutide, respectively. This sample size would provide greater than 99% power to demonstrate superiority of LY2189265 to placebo. This computation assumed a true mean difference in HbA1c change from baseline between LY2189265 and placebo being 0.8%, a common standard deviation of 1.1%, a 1-sided significance level of 0.025, and a 9% drop-out rate between randomization and Week 26.||-1.35|-1.79|<0.001
72390927|NCT01558271|144289596|NON_INFERIORITY_OR_EQUIVALENCE|If the upper limit of the 95% Confidence Interval (CI) was \<0.4%, then LY2189265 was declared non-inferior to Liraglutide. If the upper limit of the 95% CI was \<0.0%, then LY2189265 was declared superior to liraglutide.|LS Mean Difference|-0.1||||0.248|TWO_SIDED|95.0|-0.27|0.07|||Mixed Models Analysis|||Approximately 490 participants were to be randomized in a 4:1:2 ratio to LY2189265, placebo, or Liraglutide, respectively. This sample size would provide \>90% power to confirm non-inferiority of LY2189265 to liraglutide by a margin of 0.4%. This computation assumed a true mean difference in HbA1c change from baseline between LY2189265 and Liraglutide being 0%, a common standard deviation of 1.1%, a 1-sided significance level of 0.025, and a 9% drop-out rate between randomization and Week 26.||0.07|-0.27|0.248
72390928|NCT01558271|144289597|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2||||0.04|TWO_SIDED|95.0|-0.39|-0.01|||Mixed Models Analysis|||||-0.01|-0.39|0.040
72390929|NCT01558271|144289598|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Treatment comparison for HbA1c \<7% at 26 weeks between LY2189265 and placebo.|Cochran-Mantel-Haenszel|Pairwise comparison was adjusted for prestudy therapy (OAM yes/no), baseline BMI group (\<25 / \>=25 kg/m\^2), and baseline HbA1c group.||||||<0.001
72390930|NCT01558271|144289598|SUPERIORITY_OR_OTHER|||||||0.608|TWO_SIDED|||||Treatment comparison for HbA1c \<7% at 26 weeks between LY2189265 and Liraglutide.|Cochran-Mantel-Haenszel|Pairwise comparison was adjusted for prestudy therapy (OAM yes/no), baseline BMI group (\<25 / \>=25 kg/m\^2), and baseline HbA1c group.||||||0.608
72390931|NCT01558271|144289598|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Treatment comparison for HbA1c \<=6.5% at 26 weeks between LY2189265 and placebo.|Cochran-Mantel-Haenszel|Pairwise comparison was adjusted for prestudy therapy (OAM yes/no), baseline BMI group (\<25 / \>=25 kg/m\^2), and baseline HbA1c group.||||||<0.001
72390932|NCT01558271|144289598|SUPERIORITY_OR_OTHER|||||||0.844|TWO_SIDED|||||Treatment comparison for HbA1c \<=6.5% at 26 weeks between LY2189265 and Liraglutide.|Cochran-Mantel-Haenszel|Pairwise comparison was adjusted for prestudy therapy (OAM yes/no), baseline BMI group (\<25 / \>=25 kg/m\^2), and baseline HbA1c group.||||||0.844
72390933|NCT01558271|144289598|SUPERIORITY_OR_OTHER|||||||0.112|TWO_SIDED|||||Treatment comparison for HbA1c \<7% at 52 weeks between LY2189265 and Liraglutide.|Cochran-Mantel-Haenszel|Pairwise comparison was adjusted for prestudy therapy (OAM yes/no), baseline BMI group (\<25 / \>=25 kg/m\^2), and baseline HbA1c group.||||||0.112
72390934|NCT01558271|144289598|SUPERIORITY_OR_OTHER|||||||0.103|TWO_SIDED|||||Treatment comparison for HbA1c \<=6.5% at 52 weeks between LY2189265 and Liraglutide.|Cochran-Mantel-Haenszel|Pairwise comparison was adjusted for prestudy therapy (OAM yes/no), baseline BMI group (\<25 / \>=25 kg/m\^2), and baseline HbA1c group.||||||0.103
72390935|NCT01558271|144289599|SUPERIORITY_OR_OTHER||LS Mean Difference|-40.21|||<|0.001|TWO_SIDED|95.0|-47.31|-33.11||Treatment comparison for FBG at 26 weeks between LY2189265 and placebo.|Mixed Models Analysis|||||-33.11|-47.31|<0.001
72390936|NCT01558271|144289599|SUPERIORITY_OR_OTHER||LS Mean Difference|0.57||||0.835|TWO_SIDED|95.0|-4.82|5.96|||Mixed Models Analysis|Treatment comparison for FBG at 26 weeks between LY2189265 and Liraglutide.||||5.96|-4.82|0.835
72390937|NCT01558271|144289599|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.77||||0.553|TWO_SIDED|95.0|-7.65|4.1||Treatment comparison for FBG at 52 weeks between LY2189265 and Liraglutide.|Mixed Models Analysis|||||4.10|-7.65|0.553
72450072|NCT05586490|144419091|SUPERIORITY||Mean Difference (Net)|-0.68||||0.42|TWO_SIDED|||||A priori threshold for statistical significance was p \< 0.05|ANCOVA|Estimated difference between groups (alternate device and no device group) controlling for pre-trial measurements, gender, and age.||||||0.42
72450073|NCT05586490|144419091|SUPERIORITY||Mean Difference (Net)|0.57||||0.5|TWO_SIDED|||||A priori threshold for statistical significance was p \< 0.05|ANCOVA|Estimated difference between groups (research device group and no device group) controlling for pre-trial measurements, gender, and age.||||||0.50
72450074|NCT05586490|144419092|SUPERIORITY||Mean Difference (Net)|-0.03||||0.986|TWO_SIDED|||||A priori threshold for statistical significance was p \< 0.05|ANCOVA|Estimated difference between groups (alternate device and no device group) controlling for pre-trial measurements, gender, and age.||||||0.986
72450075|NCT05586490|144419092|SUPERIORITY||Mean Difference (Net)|-1.25||||0.479|TWO_SIDED|||||A priori threshold for statistical significance was p \< 0.05|ANCOVA|Estimated difference between groups (research device and no device group) controlling for pre-trial measurements, gender, and age.||||||0.479
72450076|NCT05586490|144419093|SUPERIORITY||Mean Difference (Net)|-0.195||||0.098|TWO_SIDED|||||A priori threshold for statistical significance was p \< 0.05|ANCOVA|Estimated difference between groups (alternate device and no device group) controlling for pre-trial measurements, gender, and age.||||||0.098
72450077|NCT05586490|144419093|SUPERIORITY||Mean Difference (Net)|-0.039||||0.729|TWO_SIDED|||||A priori threshold for statistical significance was p \< 0.05|ANCOVA|Estimated difference between groups (research device and no device group) controlling for pre-trial measurements, gender, and age.||||||0.729
72450078|NCT05586490|144419094|SUPERIORITY||Mean Difference (Net)|-8.15||||0.058|TWO_SIDED|||||A priori threshold for statistical significance was p \< 0.05|ANCOVA|Estimated difference between groups (alternate device and no device group) controlling for pre-trial measurements, gender, and age.||||||0.0580
72450079|NCT05586490|144419094|SUPERIORITY||Mean Difference (Net)|-1.54||||0.718|TWO_SIDED|||||A priori threshold for statistical significance was p \< 0.05|ANCOVA|Estimated difference between groups (research device and no device group) controlling for pre-trial measurements, gender, and age.||||||0.718
72450080|NCT05586490|144419096|SUPERIORITY||Mean Difference (Net)|0.063||||0.816|TWO_SIDED|||||A priori threshold for statistical significance was p \< 0.05|ANCOVA|Estimated difference between groups (alternate device and no device group) controlling for pre-trial measurements, gender, and age.||||||0.816
72450081|NCT05586490|144419096|SUPERIORITY||Mean Difference (Net)|-0.0048||||0.985|TWO_SIDED|||||A priori threshold for statistical significance was p \< 0.05|ANCOVA|Estimated difference between groups (research device and no device group) controlling for pre-trial measurements, gender, and age.||||||0.985
72450082|NCT05586490|144419097|SUPERIORITY||Mean Difference (Net)|6.33||||0.59|TWO_SIDED|||||A priori threshold for statistical significance was p \< 0.05|ANCOVA|Estimated difference between groups (alternate device and no device group) controlling for pre-trial measurements, gender, and age.||||||0.59
72450083|NCT05586490|144419097|SUPERIORITY||Mean Difference (Net)|8.16||||0.51|TWO_SIDED|||||A priori threshold for statistical significance was p \< 0.05|ANCOVA|Estimated difference between groups (research device and no device group) controlling for pre-trial measurements, gender, and age.||||||0.51
72450084|NCT02567409|144419101|SUPERIORITY||Hazard Ratio (HR)|1.17|||||TWO_SIDED|95.0|0.69|1.98|||||Hazard ratio relative to arm B.|||1.98|0.69|
72450085|NCT02567409|144419102|SUPERIORITY||Hazard Ratio (HR)|1.33|||||TWO_SIDED|95.0|0.71|2.48|||||Hazard ratio relative to arm B.|||2.48|0.71|
72450086|NCT02567409|144419103|SUPERIORITY|||||||0.51|||||||Fisher Exact|||||||0.51
72450087|NCT05280574|144419132|OTHER||Ratio of geometric means|0.75|||<|0.05|TWO_SIDED|95.0|0.51|1.1|||Distinct-effects GEE model||Average relative effect of unblinded versus blinded monitoring across the 5-component composite (SpO2 \<85%, RR \>30/min, RR \<4/min, HR \<45/min, HR \>130/min) of cumulative durations.||We assessed the treatment effect of unblinded versus blinded monitoring across the 5-component primary outcome composite of cumulative durations by estimating the average relative effect on the log-transformed count data (counts of observations beyond a given threshold at 1 Hz). Specifically, we employed a distinct-effects (i.e., separate treatment effect estimated for each component) generalized estimating equation (GEE) model to account for within-subject correlation across components with the vector of the 5 cumulative durations as the dependent variable and treatment as independent. We then averaged the component-specific effects and tested whether the average effect equals zero (on the log scale), and reported results as the ratio of geometric means of unblinded versus blinded monitoring.|1.1|0.51|< 0.05
72450088|NCT05237284|144419143|SUPERIORITY|||||||0.6999|||||||Wilcoxon (Mann-Whitney)|||CAFS at Week 24 was analyzed using the Wilcoxon-Mann-Whitney test to compare mean scores between the treatment groups at Week 24.||||0.6999
72450089|NCT05237284|144419146|SUPERIORITY||LS Mean Difference|0.52||||0.2182|TWO_SIDED|95.0|-0.31|1.35|||MMRM|||Analysis was performed using MMRM including treatment group, visit, randomization strata of the geographic region, ALS onset region, use of riluzole, use of edaravone, use of the combination of sodium phenylbutyrate and taurursodiol, treatment-by-visit interaction, disease duration, baseline ALSFRS-R score, baseline NfL, disease duration-by-visit interaction, and baseline ALSFRS-R score-by-visit interaction.||1.350|-0.310|0.2182
72450090|NCT05237284|144419147|SUPERIORITY||LS Mean Difference|0.419||||0.8134|TWO_SIDED|95.0|-3.075|3.914|||MMRM|||Analysis was performed using MMRM including treatment group, visit, randomization strata of the geographic region, ALS onset region, use of riluzole, use of edaravone, use of the combination of sodium phenylbutyrate and taurursodiol, treatment-by-visit interaction, disease duration, baseline SVC, baseline NfL, disease duration-by-visit interaction, baseline NfL-by-visit interaction, and baseline SVC-by-visit interaction.||3.914|-3.075|0.8134
72450091|NCT05237284|144419148|SUPERIORITY||Ratio of the LS Geometric Mean Ratios|0.961||||0.2356|TWO_SIDED|95.0|0.899|1.027|||MMRM|||Analysis was performed using MMRM including treatment group, visit, randomization strata of the geographic region, ALS onset region, use of riluzole, use of edaravone, use of the combination of sodium phenylbutyrate and taurursodiol, treatment-by-visit interaction, disease duration, log transformed baseline NfL, disease duration-by-visit interaction, and log transformed baseline NfL-by-visit interaction.||1.027|0.899|0.2356
72469691|NCT03635086|144463054|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|0.6||||0.933|TWO_SIDED|95.0|0.1|3.3|||ANOVA|||Day 365||3.3|0.1|0.9330
72469692|NCT03635086|144463054|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|1.3||||0.9945|TWO_SIDED|95.0|0.2|6.7|||ANOVA|||Day 365||6.7|0.2|0.9945
72450092|NCT05237284|144419149|SUPERIORITY||LS Mean difference|-0.005||||0.9565|TWO_SIDED|95.0|-0.193|0.183|||MMRM|||Analysis was performed using MMRM including treatment group, visit, randomization strata of the geographic region, ALS onset region, use of riluzole, use of edaravone, use of the combination of sodium phenylbutyrate and taurursodiol, treatment-by-visit interaction, disease duration, baseline megascore, baseline NfL, disease duration-by-visit interaction, baseline NfL-by-visit interaction and baseline megascore-by-visit interaction.||0.183|-0.193|0.9565
72450093|NCT05237284|144419154|SUPERIORITY||Least Square (LS) Mean Difference|-0.414||||0.5289|TWO_SIDED|95.0|-1.706|0.878|||MMRM|||Analysis was performed using MMRM including treatment group, visit, randomization strata of the geographic region, ALS onset region, use of riluzole, use of edaravone, use of the combination of sodium phenylbutyrate and taurursodiol, treatment-by-visit interaction, disease duration, baseline ALSFRS-R score, baseline serum neurofilament light chain (NfL), disease duration-by-visit interaction, baseline NfL-by-visit interaction and baseline ALSFRS-R score-by-visit interaction.||0.878|-1.706|0.5289
72450094|NCT05237284|144419155|SUPERIORITY|||||||0.183|||||||ANCOVA|||Analysis was performed using rank analysis of covariance (ANCOVA) model including treatment group, randomization strata of the geographic region of the study site, ALS onset region (bulbar or other areas), use of riluzole (yes or no), use of edaravone (yes or no), use of the combination of sodium phenylbutyrate and taurursodiol (yes or no), disease duration (from first symptom onset to the screening visit), baseline ALSFRS-R score and baseline NfL.||||0.1830
72450095|NCT04820322|144419301|SUPERIORITY|||||||0.087|||||||t-test, 2 sided|||||||0.087
72450096|NCT04820322|144419302|SUPERIORITY|||||||0.02|||||||t-test, 2 sided|||||||0.020
72450097|NCT04820322|144419303|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.00
72450098|NCT04820322|144419304|SUPERIORITY|||||||0.7|||||||Fisher Exact|||||||0.70
72450099|NCT04820322|144419305|SUPERIORITY|||||||0.71|||||||Fisher Exact|||||||0.71
72450100|NCT04820322|144419306|SUPERIORITY|||||||0.71|||||||Fisher Exact|||||||0.71
72450101|NCT04820322|144419307|SUPERIORITY|||||||0.67|||||||Fisher Exact|||||||0.67
72450102|NCT04820322|144419308|SUPERIORITY|||||||0.11|||||||t-test, 2 sided|||||||0.11
72498936|NCT00348140|144528164|SUPERIORITY||Mean Difference (Net)|-0.1||||0.783|TWO_SIDED|95.0|-1.1|0.9|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|||0.9|-1.1|0.783
72450103|NCT04820322|144419309|SUPERIORITY|||||||0.023|||||||t-test, 2 sided|||||||0.023
72450104|NCT04820322|144419310|SUPERIORITY|||||||0.014|||||||t-test, 2 sided|||||||0.014
72498937|NCT00348140|144528164|SUPERIORITY||Mean Difference (Net)|0.0||||0.94|TWO_SIDED|95.0|-1.1|1.1|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|||1.1|-1.1|0.940
72450105|NCT04820322|144419311|SUPERIORITY|||||||0.04|||||||t-test, 2 sided|||||||0.040
72450106|NCT02998528|144419332|SUPERIORITY||Cox Proportional Hazard|0.63||||0.0052|TWO_SIDED|97.38|0.43|0.91|||Log Rank|Stratified by PD-L1 (≥ 1% vs \<1%/unevaluable/indeterminate), disease stage (IB/II vs IIIA), and sex (male vs female)||||0.91|0.43|0.0052
72450107|NCT02998528|144419333|SUPERIORITY||% Difference|21.6|||||TWO_SIDED|99.0|13.0|30.3|||||Strata adjusted difference (Arm C - Concurrent Arm B) based on the CMH method of weighting. Stratified by PD-L1 (≥ 1% vs \<1%/unevaluable/indeterminate), disease stage (IB/II vs IIIA), and sex (male vs female)|||30.3|13.0|
72450108|NCT02998528|144419333|SUPERIORITY||Odds Ratio (OR)|13.94|||<|0.0001|TWO_SIDED|99.0|3.49|55.75|||Cochran-Mantel-Haenszel||Strata adjusted odds ratio (Arm C over Concurrent Arm B) the Mantel-Haenszel method. Stratified by PD-L1 (≥ 1% vs \<1%/unevaluable/indeterminate), disease stage (IB/II vs IIIA), and sex (male vs female)|||55.75|3.49|<0.0001
72450109|NCT02998528|144419334|SUPERIORITY||% Difference|27.9|||||TWO_SIDED|95.0|19.6|36.1|||||Strata adjusted difference (Arm C - Concurrent Arm B) based on the CMH method of weighting. Stratified by PD-L1 (≥ 1% vs \<1%/unevaluable/indeterminate), disease stage (IB/II vs IIIA), and sex (male vs female)|||36.1|19.6|
72450110|NCT02998528|144419334|SUPERIORITY||Odds Ratio (OR)|5.7|||||TWO_SIDED|95.0|3.16|10.26|||||Stratified by PD-L1 (≥ 1% vs \<1%/unevaluable/indeterminate), disease stage (IB/II vs IIIA), and sex (male vs female)|||10.26|3.16|
72450111|NCT02998528|144419336|SUPERIORITY||Hazard Ratio (HR)|0.53|||||TWO_SIDED|95.0|0.36|0.77|||||Stratified by: PD-L1 status (≥ 1% vs \<1%/not evaluable/indeterminate), disease stage (IB/II vs IIIA), and sex (male vs female)|||0.77|0.36|
72450112|NCT06029452|144419337|NON_INFERIORITY|Non-inferiority margin was 0.10.|Sensitivity|0.853|||||ONE_SIDED|95.0|0.815||||||Sensitivity was defined as the probability that an individual with the disease in the population were screen positive for disease by the algorithm (TP). Sensitivity = TP / (TP + FN).||||0.815|
72450113|NCT06029452|144419337|NON_INFERIORITY|Non-inferiority margin was 0.10.|Specificity|0.584|||||ONE_SIDED|95.0|0.539||||||Sensitivity was defined as the probability that an individual with the disease in the population were screen positive for disease by the algorithm (TP). Sensitivity = TP / (TP + FN).||||0.539|
72450114|NCT04204083|144419338|OTHER||||||<|0.0001||||||P-Value was calculated|t-test, 1 sided|||||||<0.0001
72450115|NCT04204083|144419339|OTHER||||||<|0.0001||||||P-Value was calculated|t-test, 1 sided|||||||<0.0001
72450116|NCT04204083|144419340|OTHER||||||<|0.0001||||||P-Value was calculated|t-test, 1 sided|||||||<0.0001
72450117|NCT04271046|144419397|OTHER|||||||0.97|||||||Regression, Linear|||||||0.97
72450118|NCT04271046|144419398|OTHER|||||||0.55|||||||Regression, Linear|||||||0.55
72450119|NCT04271046|144419399|OTHER|||||||0.26|||||||Regression, Linear|||||||0.26
72450120|NCT04271046|144419400|OTHER|||||||0.42|||||||Regression, Linear|||||||0.42
72450121|NCT04271046|144419407|OTHER|||||||0.08|||||||Regression, Linear|||||||0.08
72450122|NCT04271046|144419408|OTHER|||||||0.79|||||||Regression, Linear|||||||0.79
72450123|NCT04271046|144419409|OTHER|||||||0.6|||||||Regression, Linear|||||||0.60
72450124|NCT04271046|144419410|OTHER|||||||0.86|||||||Regression, Linear|||||||0.86
72450125|NCT04271046|144419411|OTHER|||||||0.46|||||||Regression, Linear|||||||0.46
72450126|NCT04271046|144419412|OTHER|||||||0.55|||||||Regression, Linear|||||||0.55
72450127|NCT04271046|144419413|OTHER|||||||0.63|||||||Regression, Linear|||||||0.63
72450128|NCT04271046|144419414|OTHER|||||||0.28|||||||Regression, Linear|||||||0.28
72450129|NCT04271046|144419415|OTHER|||||||0.82|||||||Regression, Linear|||||||0.82
72450130|NCT04271046|144419416|OTHER|||||||0.04|||||||Regression, Linear|||||||0.04
72498938|NCT00348140|144528165|SUPERIORITY||Mean Difference (Net)|-0.1|||=|0.763|TWO_SIDED|95.0|-1.1|0.8|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|||0.8|-1.1|=0.763
72498939|NCT00348140|144528165|SUPERIORITY||Mean Difference (Net)|-0.1|||=|0.8|TWO_SIDED|95.0|-1.1|0.9|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|||0.9|-1.1|=0.800
72498940|NCT00348140|144528166|SUPERIORITY||Mean Difference (Net)|-0.1||||0.611|TWO_SIDED|95.0|-0.7|0.4|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|||0.4|-0.7|0.611
72498941|NCT00348140|144528166|SUPERIORITY||Mean Difference (Net)|-0.1||||0.741|TWO_SIDED|95.0|-0.6|0.4|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|||0.4|-0.6|0.741
72498942|NCT00348140|144528167|SUPERIORITY||Mean Difference (Net)|0.0||||0.913|TWO_SIDED|95.0|-0.4|0.3|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|||0.3|-0.4|0.913
72390938|NCT01558271|144289601|SUPERIORITY_OR_OTHER||LS Mean Difference|0.61||||0.057|TWO_SIDED|95.0|-0.02|1.23|||Mixed Models Analysis|Treatment comparison for body weight at 26 weeks between LY2189265 and placebo.||||1.23|-0.02|0.057
72498943|NCT00348140|144528167|SUPERIORITY||Mean Difference (Net)|-0.1||||0.481|TWO_SIDED|95.0|-0.5|0.2|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|||0.2|-0.5|0.481
72390939|NCT01558271|144289601|SUPERIORITY_OR_OTHER||LS Mean Difference|0.34||||0.168|TWO_SIDED|95.0|-0.14|0.82||Treatment comparison for body weight at 26 weeks between LY2189265 and Liraglutide.|Mixed Models Analysis|||||0.82|-0.14|0.168
72498944|NCT00348140|144528168|SUPERIORITY||Mean Difference (Net)|-0.1||||0.557|TWO_SIDED|95.0|-0.4|0.2|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|||0.2|-0.4|0.557
72498945|NCT00348140|144528168|SUPERIORITY||Mean Difference (Net)|-0.1||||0.404|TWO_SIDED|95.0|-0.5|0.2|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|||0.2|-0.5|0.404
72498946|NCT00348140|144528169|SUPERIORITY||Mean Difference (Net)|0.1||||0.633|TWO_SIDED|95.0|-0.5|0.8|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|For Week 8||0.8|-0.5|0.633
72498947|NCT00348140|144528169|SUPERIORITY||Mean Difference (Net)|0.2||||0.575|TWO_SIDED|95.0|-0.4|0.8|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|For Week 8||0.8|-0.4|0.575
72498948|NCT00348140|144528169|SUPERIORITY||Mean Difference (Net)|0.1||||0.82|TWO_SIDED|95.0|-0.6|0.7|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|For Week 16||0.7|-0.6|0.820
72450131|NCT04271046|144419417|OTHER|||||||0.98|||||||Regression, Linear|||||||0.98
72450132|NCT04271046|144419418|OTHER|||||||0.22|||||||Regression, Linear|||||||0.22
72450133|NCT04271046|144419419|OTHER|||||||0.85|||||||Regression, Linear|||||||0.85
72390940|NCT01558271|144289601|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.03||||0.911|TWO_SIDED|95.0|-0.64|0.57||Treatment comparison for body weight at 52 weeks between LY2189265 and Liraglutide.|Mixed Models Analysis|||||0.57|-0.64|0.911
72390941|NCT01558271|144289602|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.86||||0.723|TWO_SIDED|95.0|-12.2|8.48||Treatment comparison for HOMA2-%S based on fasting insulin at 26 weeks between LY2189265 and placebo.|ANCOVA|||||8.48|-12.20|0.723
72450134|NCT04271046|144419420|OTHER|||||||0.8|||||||Regression, Linear|||||||0.80
72450135|NCT05218096|144419437|OTHER|Difference|Difference|-7.1||||0.6797|TWO_SIDED|90.0|-28.8|15.0|||Barnard's Unconditional Exact Test||CI calculated using the Chan and Zhang method.|||15.0|-28.8|0.6797
72450136|NCT05218096|144419437|OTHER|Difference|Difference|-7.1||||0.7341|TWO_SIDED|90.0|-34.8|19.3|||Barnard's Unconditional Exact Test||CI calculated using the Chan and Zhang method.|||19.3|-34.8|0.7341
72450137|NCT05618587|144419446|SUPERIORITY|||||||0.46|||||||t-test, 2 sided|||||||0.46
72450138|NCT05618587|144419447|SUPERIORITY|||||||0.79|||||||t-test, 2 sided|||||||0.79
72450139|NCT05618587|144419448|SUPERIORITY|||||||0.68|||||||t-test, 2 sided|||||||0.68
72450140|NCT05618587|144419449|SUPERIORITY|||||||0.89|||||||t-test, 2 sided|||||||0.89
72450141|NCT05618587|144419450|SUPERIORITY|||||||0.75|||||||t-test, 2 sided|||||||0.75
72450142|NCT05618587|144419451|SUPERIORITY|||||||1|||||||Barnard unconditional exact test|||||||1.0
72450143|NCT05618587|144419452|SUPERIORITY|||||||0.28|||||||t-test, 2 sided|||||||0.28
72450144|NCT05618587|144419453|SUPERIORITY|||||||0.58|||||||t-test, 2 sided|||||||0.58
72450145|NCT05618587|144419454|SUPERIORITY|||||||0.41|||||||t-test, 2 sided|||||||0.41
72450146|NCT05618587|144419455|SUPERIORITY|||||||0.5|||||||t-test, 2 sided|||||||0.50
72450147|NCT05618587|144419456|SUPERIORITY|||||||0.29|||||||t-test, 2 sided|||||||0.29
72450148|NCT05618587|144419457|SUPERIORITY|||||||0.35|||||||t-test, 2 sided|||||||0.35
72450149|NCT03442309|144419470|NON_INFERIORITY|NI margin for arrest difference of 10%|Mean Difference (Final Values)|-0.11|||||TWO_SIDED|95.0|-0.22|0.01||||||||0.01|-.22|
72619589|NCT02070380|144770024|SUPERIORITY_OR_OTHER|||||||0.8238||||||The priori threshold for statistical significance was 0.05.|Wilcoxon signed-rank test|||"This is a secondary analysis.~Null hypotheses:~A 0.05 mmol/kg dose of MULTIHANCE is equal to a 0.1 mmol/kg dose of DOTAREM, in terms of the assessment of Lesion Border Delineation in an off-site pre-dose plus post-dose paired global assessment."||||0.8238
72498949|NCT00348140|144528169|SUPERIORITY||Mean Difference (Net)|0.0||||0.908|TWO_SIDED|95.0|-0.7|0.6|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|For Week 16||0.6|-0.7|0.908
72619590|NCT02070380|144770024|SUPERIORITY_OR_OTHER||||||<|0.0001||||||The priori threshold for statistical significance was 0.05.|Wilcoxon signed rank test|||"This is a secondary analysis.~Null hypotheses:~A 0.1 mmol/kg dose of MULTIHANCE is equal to a 0.1 mmol/kg dose of DOTAREM, in terms of the assessment of Lesion Border Delineation in an off-site pre-dose plus postdose paired global assessment."||||<0.0001
72619591|NCT02070380|144770024|SUPERIORITY_OR_OTHER|||||||0.4597||||||The priori threshold for statistical significance was 0.05.|Wilcoxon signed rank test|||"This is a secondary analysis.~Null hypotheses:~A 0.05 mmol/kg dose of MULTIHANCE is equal to a 0.1 mmol/kg dose of DOTAREM, in terms of the assessment of Lesion Border Delineation in an off-site pre-dose plus postdose paired global assessment."||||0.4597
72619592|NCT02070380|144770024|SUPERIORITY_OR_OTHER||||||<|0.0001||||||The priori threshold for statistical significance was 0.05.|Wilcoxon signed rank test|||"This is a secondary analysis.~Null hypotheses:~A 0.1 mmol/kg dose of MULTIHANCE is equal to a 0.1 mmol/kg dose of DOTAREM, in terms of the assessment of Lesion Border Delineation in an off-site pre-dose plus postdose paired global assessment."||||<0.0001
72619593|NCT02070380|144770024|SUPERIORITY_OR_OTHER|||||||0.8145||||||The priori threshold for statistical significance was 0.05.|Wilcoxon signed rank test|||"This is a secondary analysis.~Null hypotheses:~A 0.05 mmol/kg dose of MULTIHANCE is equal to a 0.1 mmol/kg dose of DOTAREM, in terms of the assessment of Lesion Border Delineation in an off-site pre-dose plus postdose paired global assessment."||||0.8145
72619594|NCT02070380|144770025|SUPERIORITY_OR_OTHER|||||||0.002|||||||Wilcoxon signed-rank test|||"Null hypotheses:~A 0.1 mmol/kg dose of MULTIHANCE is equal to a 0.1 mmol/kg dose of DOTAREM, in terms of the assessment of Lesion Internal Morphology in an off-site pre-dose plus postdose paired global assessment."||||0.0020
72619595|NCT02070380|144770025|SUPERIORITY_OR_OTHER|||||||1|||||||Wilcoxon signed-rank test|||"Null hypotheses:~A 0.05 mmol/kg dose of MULTIHANCE is equal to a 0.1 mmol/kg dose of DOTAREM, in terms of the assessment of Lesion Internal Morphology in an off-site pre-dose plus post-dose paired global assessment."||||1.0000
72619596|NCT02070380|144770025|SUPERIORITY_OR_OTHER|||||||0.0001|||||||Wilcoxon signed-rank test|||"Null hypotheses:~A 0.1 mmol/kg dose of MULTIHANCE is equal to a 0.1 mmol/kg dose of DOTAREM, in terms of the assessment of Lesion Internal Morphology in an off-site pre-dose plus postdose paired global assessment."||||0.0001
72619597|NCT02070380|144770025|SUPERIORITY_OR_OTHER|||||||1|||||||Wilcoxon signed-rank test|||"Null hypotheses:~A 0.05 mmol/kg dose of MULTIHANCE is equal to a 0.1 mmol/kg dose of DOTAREM, in terms of the assessment of Lesion Internal Morphology in an off-site pre-dose plus postdose paired global assessment."||||1.0000
72390942|NCT01558271|144289602|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.01||||0.998|TWO_SIDED|95.0|-7.92|7.91||Treatment comparison for HOMA2-%S based on fasting insulin at 26 weeks between LY2189265 and Liraglutide.|ANCOVA|||||7.91|-7.92|0.998
72390943|NCT01558271|144289602|SUPERIORITY_OR_OTHER||LS Mean Difference|0.83||||0.848|TWO_SIDED|95.0|-7.72|9.38||Treatment comparison for HOMA2-%S based on fasting C-peptide at 26 weeks between LY2189265 and placebo.|ANCOVA|||||9.38|-7.72|0.848
72390944|NCT01558271|144289602|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.03||||0.357|TWO_SIDED|95.0|-9.48|3.42||Treatment comparison for HOMA2-%S based on fasting C-peptide at 26 weeks between LY2189265 and Liraglutide.|ANCOVA|||||3.42|-9.48|0.357
72390945|NCT01558271|144289602|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.49||||0.533|TWO_SIDED|95.0|-10.35|5.36||Treatment comparison for HOMA2-%S based on fasting insulin at 52 weeks between LY2189265 and Liraglutide.|ANCOVA|||||5.36|-10.35|0.533
72390946|NCT01558271|144289602|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.03||||0.747|TWO_SIDED|95.0|-7.32|5.25||Treatment comparison for HOMA2-%S based on fasting C-peptide at 52 weeks between LY2189265 and Liraglutide.|ANCOVA|||||5.25|-7.32|0.747
72390947|NCT01558271|144289603|SUPERIORITY_OR_OTHER||LS Mean Difference|28.35|||<|0.001|TWO_SIDED|95.0|21.63|35.07||Treatment comparison for HOMA2-%B based on fasting insulin at 26 weeks between LY2189265 and placebo.|ANCOVA|||||35.07|21.63|<0.001
72450150|NCT03442309|144419471|NON_INFERIORITY|Non-inferiority OR (OR δ, 0.63)|Odds Ratio (OR)|0.94|||||TWO_SIDED|90.0|0.82|1.08||||||||1.08|0.82|
72450151|NCT05290493|144419524|SUPERIORITY|||||||0.0672|||||||Mixed Models Analysis|||||||0.0672
72450152|NCT05290493|144419525|SUPERIORITY|||||||0.2045|||||||Mixed Models Analysis|||||||0.2045
72450153|NCT05290493|144419526|SUPERIORITY|||||||0.2931|||||||Mixed Models Analysis|||||||0.2931
72450154|NCT05290493|144419527|SUPERIORITY|||||||0.7799|||||||Mixed Models Analysis|||||||0.7799
72450155|NCT05290493|144419528|SUPERIORITY|||||||0.7974|||||||Mixed Models Analysis|||||||0.7974
72450156|NCT05290493|144419529|SUPERIORITY|||||||0.8286|||||||Mixed Models Analysis|||||||0.8286
72450157|NCT05419830|144419531|OTHER|Three-group ANCOVA comparisons were completed using pre- to post-intervention changes in sleep time dip in systolic BP. Analysis was adjusted for baseline value of the outcome||||||0.65|||||||ANCOVA|||||||0.65
72450158|NCT05419830|144419532|OTHER|Three-group ANCOVA comparisons were completed using pre- to post-intervention changes in nocturia frequency. Analysis was adjusted for baseline value of the outcome||||||0.66|||||||ANCOVA|||||||0.66
72619598|NCT02070380|144770025|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon signed-rank test|||"Null hypotheses:~A 0.1 mmol/kg dose of MULTIHANCE is equal to a 0.1 mmol/kg dose of DOTAREM, in terms of the assessment of Lesion Internal Morphology in an off-site pre-dose plus postdose paired global assessment."||||<0.0001
72450159|NCT05419830|144419533|OTHER|Three-group ANCOVA comparisons were completed using pre- to post-intervention changes in NPi. Analysis was adjusted for baseline value of the outcome||||||0.14|||||||ANCOVA|||||||0.14
72450160|NCT05419830|144419534|OTHER|Three-group ANCOVA comparisons were completed using pre- to post-intervention changes in PSQI scores. Analysis was adjusted for baseline value of the outcome||||||0.2|||||||ANCOVA|||||||0.2
72450161|NCT05419830|144419535|OTHER|Three-group ANCOVA comparisons were completed using pre- to post-intervention changes in sleep efficiency. Analysis was adjusted for baseline value of the outcome||||||0.02|||||||ANCOVA|||||||0.02
72450162|NCT04615273|144419550|SUPERIORITY||Estimate of Difference|-2.04|STANDARD_ERROR_OF_MEAN|0.46|<|0.0001|TWO_SIDED|95.0|-2.94|-1.14|||ANCOVA|||Analysis included treatment arm, region, baseline age group, gender, concomitant oral estrogen, Adult Growth Hormone Deficiency (AGHD) onset as factors \& baseline trunk percent fat as the covariates. Multiple imputation method was used to impute missing data.||-1.14|-2.94|<.0001
72450163|NCT03677141|144419554|SUPERIORITY||Difference in rates|-4.77|||||TWO_SIDED|95.0|-30.61|21.07||||||||21.07|-30.61|
72450164|NCT05465239|144419571|EQUIVALENCE|Equivalence analysis of metabolic energy consumption using the unpowered vs powered walker for control subjects.|||||<|0.001|||||||t-test, 1 sided|||||||< 0.001
72450165|NCT05465239|144419571|EQUIVALENCE|Equivalence analysis of metabolic energy consumption using the unpowered vs powered walker for subjects with walking disabilities.|||||<|0.001|||||||t-test, 1 sided|||||||<0.001
72450166|NCT05838027|144419596|SUPERIORITY|All panel-data marginal models use robust standard errors. Categorical outcomes were assessed with ordered logistic models and continuous outcomes were assessed with GEE population-averaged models, except Medication Expenditures which used Poisson models to account for count data. Some outcomes are missing additional data (not \>10%).|Odds Ratio (OR)|3.24|||||TWO_SIDED|95.0|0.84|12.55||||||||12.55|0.84|
72450167|NCT05838027|144419597|SUPERIORITY|All panel-data marginal models use robust standard errors. Categorical outcomes were assessed with ordered logistic models and continuous outcomes were assessed with GEE population-averaged models, except Medication Expenditures which used Poisson models to account for count data. Some outcomes are missing additional data (not \>10%).|Odds Ratio (OR)|0.79|||||TWO_SIDED|95.0|0.24|2.64||||||||2.64|0.24|
72450168|NCT05838027|144419598|SUPERIORITY|All panel-data marginal models use robust standard errors. Categorical outcomes were assessed with ordered logistic models and continuous outcomes were assessed with GEE population-averaged models, except Medication Expenditures which used Poisson models to account for count data. Some outcomes are missing additional data (not \>10%).|Mean Difference (Net)|0.52|||||TWO_SIDED|95.0|-3.78|4.82||||||||4.82|-3.78|
72450169|NCT05838027|144419599|SUPERIORITY|All panel-data marginal models use robust standard errors. The binary outcome, Future Preference: Behavioral task was assessed with a logistic model and continuous outcomes were assessed with GEE population-averaged models, except All Health Care Expenditures which used Poisson models to account for count data. Some outcomes are missing additional data (not \>10%).|Mean Difference (Net)|0.2|||||TWO_SIDED|95.0|-1.01|1.4||||||||1.40|-1.01|
72450170|NCT05838027|144419600|SUPERIORITY|All panel-data marginal models use robust standard errors. The binary outcome, Future Preference: Behavioral task was assessed with a logistic model and continuous outcomes were assessed with GEE population-averaged models, except All Health Care Expenditures which used Poisson models to account for count data. Some outcomes are missing additional data (not \>10%).|Mean Difference (Net)|-2.71|||||TWO_SIDED|95.0|-7.43|2.0||||||||2.00|-7.43|
72450171|NCT05838027|144419601|SUPERIORITY|All panel-data marginal models use robust standard errors. Categorical outcomes were assessed with ordered logistic models and continuous outcomes were assessed with GEE population-averaged models, except Medication Expenditures which used Poisson models to account for count data. Some outcomes are missing additional data (not \>10%).|Mean Difference (Net)|-0.65|||||TWO_SIDED|95.0|-5.45|4.16||||||||4.16|-5.45|
72390948|NCT01558271|144289603|SUPERIORITY_OR_OTHER||LS Mean Difference|3.08||||0.242|TWO_SIDED|95.0|-2.09|8.24||Treatment comparison for HOMA2-%B based on fasting insulin at 26 weeks between LY2189265 and Liraglutide.|ANCOVA|||||8.24|-2.09|0.242
72390949|NCT01558271|144289603|SUPERIORITY_OR_OTHER||LS Mean Difference|24.82|||<|0.001|TWO_SIDED|95.0|19.25|30.4||Treatment comparison for HOMA2-%B based on fasting C-peptide at 26 weeks between LY2189265 and placebo.|ANCOVA|||||30.40|19.25|<0.001
72390950|NCT01558271|144289603|SUPERIORITY_OR_OTHER||LS Mean Difference|1.91||||0.376|TWO_SIDED|95.0|-2.32|6.13||Treatment comparison for HOMA2-%B based on fasting C-peptide at 26 weeks between LY2189265 and Liraglutide.|ANCOVA|||||6.13|-2.32|0.376
72390951|NCT01558271|144289603|SUPERIORITY_OR_OTHER||LS Mean Difference|1.91||||0.417|TWO_SIDED|95.0|-2.72|6.54||Treatment comparison for HOMA2-%B based on fasting insulin at 52 weeks between LY2189265 and Liraglutide.|ANCOVA|||||6.54|-2.72|0.417
72390952|NCT01558271|144289603|SUPERIORITY_OR_OTHER||LS Mean Difference|0.73||||0.753|TWO_SIDED|95.0|-3.83|5.29||Treatment comparison for HOMA2-%B based on fasting C-peptide at 52 weeks between LY2189265 and Liraglutide.|ANCOVA|||||5.29|-3.83|0.753
72390953|NCT01558271|144289604|SUPERIORITY_OR_OTHER||||||>|0.999|TWO_SIDED|||||Treatment comparison at 26 weeks between LY2189265 and placebo.|Fisher Exact|||||||>0.999
72390954|NCT01558271|144289604|SUPERIORITY_OR_OTHER||||||>|0.999|TWO_SIDED|||||Treatment comparison at 26 weeks between LY2189265 and Liraglutide.|Fisher Exact|||||||>0.999
72390955|NCT01558271|144289604|SUPERIORITY_OR_OTHER||||||>|0.999|TWO_SIDED|||||Treatment comparison at 52 weeks between LY2189265 and Liraglutide.|Fisher Exact|||||||>0.999
72390956|NCT02610725|144289626|SUPERIORITY||Mean Difference (Final Values)|-2.1|STANDARD_DEVIATION|0.81||0.013|TWO_SIDED|95.0|-3.73|-0.46|||t-test, 2 sided|51 degrees of freedom.|Means were analyzed in (pre-post) format. A negative mean here indicates an increase in positive affect.|Paired-samples t-tests were used to analyze change in affect after participating in the yoga class. Analyses were conducted to measure changes in both positive affect and negative affect. This entry describes positive affect analysis.||-0.46|-3.73|0.013
72450172|NCT05838027|144419602|SUPERIORITY|All panel-data marginal models use robust standard errors. The binary outcome, Future Preference: Behavioral task was assessed with a logistic model and continuous outcomes were assessed with GEE population-averaged models, except All Health Care Expenditures which used Poisson models to account for count data. Some outcomes are missing additional data (not \>10%).|IRR|1.12|||||TWO_SIDED|95.0|0.46|2.74||||||||2.74|0.46|
72469693|NCT03635086|144463054|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|1.5||||0.9599|TWO_SIDED|95.0|0.3|8.4|||ANOVA|||Day 365||8.4|0.3|0.9599
72450173|NCT05838027|144419603|SUPERIORITY|All panel-data marginal models use robust standard errors. Categorical outcomes were assessed with ordered logistic models and continuous outcomes were assessed with GEE population-averaged models, except Medication Expenditures which used Poisson models to account for count data. Some outcomes are missing additional data (not \>10%).|Mean Difference (Net)|-0.75|||||TWO_SIDED|95.0|-1.29|-0.21||||||||-0.21|-1.29|
72450174|NCT05838027|144419606|SUPERIORITY|All panel-data marginal models use robust standard errors. The binary outcome, Future Preference: Behavioral task was assessed with a logistic model and continuous outcomes were assessed with GEE population-averaged models, except All Health Care Expenditures which used Poisson models to account for count data. Some outcomes are missing additional data (not \>10%).|Mean Difference (Net)|0.57|||||TWO_SIDED|95.0|-1.9|3.03||||||||3.03|-1.90|
72450175|NCT05838027|144419607|SUPERIORITY|All panel-data marginal models use robust standard errors. The binary outcome, Future Preference: Behavioral task was assessed with a logistic model and continuous outcomes were assessed with GEE population-averaged models, except All Health Care Expenditures which used Poisson models to account for count data. Some outcomes are missing additional data (not \>10%).|Mean Difference (Net)|0.13|||||TWO_SIDED|95.0|-0.32|0.58||||||||0.58|-0.32|
72450176|NCT05838027|144419608|SUPERIORITY|All panel-data marginal models use robust standard errors. The binary outcome, Future Preference: Behavioral task was assessed with a logistic model and continuous outcomes were assessed with GEE population-averaged models, except All Health Care Expenditures which used Poisson models to account for count data. Some outcomes are missing additional data (not \>10%).|IRR|0.62|||||TWO_SIDED|95.0|0.23|1.63||||||||1.63|0.23|
72450177|NCT05838027|144419609|SUPERIORITY|All panel-data marginal models use robust standard errors. The binary outcome, Future Preference: Behavioral task was assessed with a logistic model and continuous outcomes were assessed with GEE population-averaged models, except All Health Care Expenditures which used Poisson models to account for count data. Some outcomes are missing additional data (not \>10%).|Mean Difference (Net)|1.05|||||TWO_SIDED|95.0|-0.54|2.64||||||||2.64|-0.54|
72450178|NCT05838027|144419610|SUPERIORITY|All panel-data marginal models use robust standard errors. The binary outcome, Future Preference: Behavioral task was assessed with a logistic model and continuous outcomes were assessed with GEE population-averaged models, except All Health Care Expenditures which used Poisson models to account for count data. Some outcomes are missing additional data (not \>10%).|Odds Ratio (OR)|1.03|||||TWO_SIDED|95.0|0.19|5.49||||||||5.49|0.19|
72450179|NCT05838027|144419611|SUPERIORITY|All panel-data marginal models use robust standard errors. The binary outcome, Future Preference: Behavioral task was assessed with a logistic model and continuous outcomes were assessed with GEE population-averaged models, except All Health Care Expenditures which used Poisson models to account for count data. Some outcomes are missing additional data (not \>10%).|Mean Difference (Net)|-1.1|||||TWO_SIDED|95.0|-2.64|0.43||||||||0.43|-2.64|
72450180|NCT05838027|144419612|SUPERIORITY|All panel-data marginal models use robust standard errors. The binary outcome, Future Preference: Behavioral task was assessed with a logistic model and continuous outcomes were assessed with GEE population-averaged models, except All Health Care Expenditures which used Poisson models to account for count data. Some outcomes are missing additional data (not \>10%).|Mean Difference (Net)|2.72|||||TWO_SIDED|95.0|-1.35|6.8||||||||6.80|-1.35|
72450181|NCT05838027|144419613|SUPERIORITY|All panel-data marginal models use robust standard errors. The binary outcome, Future Preference: Behavioral task was assessed with a logistic model and continuous outcomes were assessed with GEE population-averaged models, except All Health Care Expenditures which used Poisson models to account for count data. Some outcomes are missing additional data (not \>10%).|Mean Difference (Net)|-0.69|||||TWO_SIDED|95.0|-1.74|0.36||||||||0.36|-1.74|
72450182|NCT03505008|144419649|NON_INFERIORITY|Two-sided 90% CI for the intergroup difference in SDAI remission rates to exceed the non-inferiority margin of -15%|Risk Difference (RD)|0.0|||||TWO_SIDED|90.0||||||||||||
72450183|NCT03687762|144419668|OTHER|We hypothesized negligible between condition differences, although within each condition, we hypothesized that each treatment would produce medium effect size improvements.|||||>|0.05|||||||ANOVA|||||||>.05
72450184|NCT03687762|144419669|OTHER|We hypothesized negligible between condition differences, although within each condition, we hypothesized that each treatment would produce medium effect size improvements.|||||>|0.05|||||||ANOVA|||||||>.05
72450185|NCT03687762|144419670|OTHER|We hypothesized negligible between condition differences, although within each condition, we hypothesized that each treatment would produce medium effect size improvements.|||||>|0.05|||||||ANOVA|||||||>.05
72450186|NCT03687762|144419671|OTHER|We hypothesized negligible between condition differences, although within each condition, we hypothesized that each treatment would produce medium effect size improvements.|||||>|0.05|||||||ANOVA|||||||>.05
72450187|NCT03687762|144419672|OTHER|We hypothesized negligible between condition differences, although within each condition, we hypothesized that each treatment would produce medium effect size improvements.|||||>|0.05|||||||ANOVA|||||||>.05
72450188|NCT03687762|144419673|OTHER|We hypothesized negligible between condition differences, although within each condition, we hypothesized that each treatment would produce medium effect size improvements.||||||0.01|||||||ANOVA|||||||0.01
72450189|NCT03687762|144419674|OTHER|We hypothesized negligible between condition differences, although within each condition, we hypothesized that each treatment would produce medium effect size improvements.|||||>|0.05|||||||ANOVA|||||||>.05
72619599|NCT02070380|144770025|SUPERIORITY_OR_OTHER|||||||0.5811|||||||Wilcoxon signed-rank test|||"Null hypotheses:~A 0.05 mmol/kg dose of MULTIHANCE is equal to a 0.1 mmol/kg dose of DOTAREM, in terms of the assessment of Lesion Internal Morphology in an off-site pre-dose plus postdose paired global assessment."||||0.5811
72450190|NCT03687762|144419675|OTHER|We hypothesized negligible between condition differences, although within each condition, we hypothesized that each treatment would produce medium effect size improvements.|||||>|0.05|||||||ANOVA|||||||>.05
72450191|NCT03687762|144419676|OTHER|We hypothesized negligible between condition differences, although within each condition, we hypothesized that each treatment would produce a greater proportion of people decreasing their dose relative to those increasing their dose during treatment.|||||>|0.05|||||||Chi-squared|||||||>.05
72450192|NCT03687762|144419677|OTHER|We hypothesized negligible between condition differences, although within each condition, we hypothesized that each treatment would produce medium effect size improvements.|||||>|0.05|||||||ANOVA|||||||>.05
72450193|NCT03687762|144419678|OTHER|We hypothesized negligible between condition differences, although within each condition, we hypothesized that each treatment would produce medium effect size improvements.|||||>|0.05|||||||ANOVA|||||||>.05
72450194|NCT03687762|144419679|OTHER|We hypothesized negligible between condition differences, although within each condition, we hypothesized that each treatment would produce medium effect size improvements.|||||>|0.05|||||||ANOVA|||||||>.05
72450195|NCT03687762|144419680|OTHER|We hypothesized negligible between condition differences, although within each condition, we hypothesized that each treatment would produce medium effect size improvements.|||||>|0.05|||||||ANOVA|||||||>.05
72450196|NCT03687762|144419681|OTHER|We hypothesized negligible between condition differences, although within each condition, we hypothesized that each treatment would produce medium effect size improvements.|||||>|0.05|||||||ANOVA|||||||>.05
72450197|NCT03687762|144419682|OTHER|We hypothesized negligible between condition differences, although within each condition, we hypothesized that each treatment would produce medium effect size improvements.|||||>|0.05|||||||ANOVA|||||||>.05
72450198|NCT03687762|144419683|OTHER|We hypothesized negligible between condition differences, although within each condition, we hypothesized that each treatment would produce medium effect size improvements.|||||>|0.05|||||||ANOVA|||||||>.05
72450199|NCT04200313|144419703|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
72450200|NCT04200313|144419703|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
72450201|NCT04200313|144419704|NON_INFERIORITY|Non-inferiority with a 1% non-inferiority margin|||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
72450202|NCT04200313|144419704|NON_INFERIORITY|Non-inferiority with a 1% non-inferiority margin|||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
72450203|NCT04200313|144419705|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
72450204|NCT04200313|144419705|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
72450205|NCT04200313|144419706|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
72450206|NCT04200313|144419706|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
72498950|NCT00348140|144528169|SUPERIORITY||Mean Difference (Net)|0.4||||0.292|TWO_SIDED|95.0|-0.3|1.1|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|For Week 24||1.1|-0.3|0.292
72450207|NCT04200313|144419707|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
72450208|NCT04200313|144419707|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
72450209|NCT04200313|144419708|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
72450210|NCT04200313|144419708|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
72450211|NCT04200313|144419709|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
72450212|NCT04200313|144419709|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
72450213|NCT04200313|144419710|SUPERIORITY|||||||0.51|||||||Mixed Models Analysis|||||||0.51
72450214|NCT04200313|144419710|SUPERIORITY|||||||0.54|||||||Mixed Models Analysis|||||||0.54
72450215|NCT03580356|144419778|SUPERIORITY|Wald chi-square test based on logistic regression|Odds Ratio (OR)|9.029|||<|0.0001|TWO_SIDED|95.0|3.183|25.615|||Regression, Logistic|95% confidence interval for the odds ratio||Adults only||25.615|3.183|<.0001
72450216|NCT03580356|144419778|SUPERIORITY|Wald chi-square test based on logistic regression|Odds Ratio (OR)|0.926||||0.6646|TWO_SIDED|95.0|0.65|1.319|||Regression, Logistic|95% confidence interval for the odds ratio||Adults only||1.319|0.650|0.6646
72450217|NCT03580356|144419778|SUPERIORITY|Wald chi-square test based on logistic regression|Odds Ratio (OR)|11.508|||<|0.0001|TWO_SIDED|95.0|4.058|32.638|||Regression, Logistic|95% confidence interval for the odds ratio||Adults only||32.638|4.058|<.0001
72450218|NCT03580356|144419778|SUPERIORITY|Wald chi-square test based on logistic regression|Odds Ratio, log|1.181||||0.173|TWO_SIDED|95.0|0.836|1.667|||Regression, Logistic|95% confidence interval for the odds ratio||Adults only||1.667|0.836|0.1730
72450219|NCT03580356|144419779|SUPERIORITY||LS Mean|-9.997|STANDARD_ERROR_OF_MEAN|1.305|<|0.0001|TWO_SIDED|95.0|-12.554|-7.439|||Mixed Models Analysis|Linear mixed model with repeated measures (MMRM)||Treatment contrast in LS mean (change), Adults only||-7.439|-12.554|<.0001
72450220|NCT03580356|144419779|SUPERIORITY||LS mean|0.414|STANDARD_ERROR_OF_MEAN|0.922||0.6735|TWO_SIDED|95.0|-1.392|2.221|||Mixed Models Analysis|Linear mixed model with repeated measures (MMRM)||Treatment contrast in LS mean (change), Adults only||2.221|-1.392|0.6735
72450221|NCT03580356|144419779|SUPERIORITY||LS Mean|-11.091|STANDARD_ERROR_OF_MEAN|1.313|<|0.0001|TWO_SIDED|95.0|-13.664|-8.518|||Mixed Models Analysis|Linear mixed model with repeated measures (MMRM)||Treatment contrast in LS mean (change), Adults only||-8.518|-13.664|<.0001
72450222|NCT03580356|144419779|SUPERIORITY||LS mean|-0.68|STANDARD_ERROR_OF_MEAN|0.923||0.2305|TWO_SIDED|95.0|-2.489|1.128|||Mixed Models Analysis|Linear mixed model with repeated measures (MMRM)||Treatment contrast in LS mean (change), Adults only||1.128|-2.489|0.2305
72450223|NCT03580356|144419781|SUPERIORITY||LS Mean|-4.105|STANDARD_ERROR_OF_MEAN|0.6|<|0.0001|TWO_SIDED|95.0|-5.281|-2.929|||Mixed Models Analysis|Linear mixed model with repeated measures (MMRM)||Adults only||-2.929|-5.281|<.0001
72450224|NCT03580356|144419781|SUPERIORITY||LS Mean|0.101|STANDARD_ERROR_OF_MEAN|0.422||0.5943|TWO_SIDED|95.0|-0.727|0.928|||Mixed Models Analysis|Linear mixed model with repeated measures (MMRM)||Adults only||0.928|-0.727|0.5943
72450225|NCT03580356|144419781|SUPERIORITY|Adults only|LS Mean|-4.496|STANDARD_ERROR_OF_MEAN|0.603|<|0.0001|TWO_SIDED|95.0|-5.678|-3.314|||Mixed Models Analysis|Linear mixed model with repeated measures (MMRM)||||-3.314|-5.678|<.0001
72450226|NCT03580356|144419781|SUPERIORITY||LS Mean|-0.29|STANDARD_ERROR_OF_MEAN|0.423||0.2467|TWO_SIDED|95.0|-1.12|0.54|||Mixed Models Analysis|Linear mixed model with repeated measures (MMRM)||Adults only||0.540|-1.120|0.2467
72450227|NCT03580356|144419783|SUPERIORITY|Wald chi-square test based on logistic regression|Odds Ratio (OR)|3.443|||<|0.0001|TWO_SIDED|95.0|1.955|6.063|||Regression, Logistic|95% confidence interval for the odds ratio||Adults only||6.063|1.955|<.0001
72498951|NCT00348140|144528169|SUPERIORITY||Mean Difference (Net)|0.0||||0.978|TWO_SIDED|95.0|-0.7|0.7|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|For Week 24||0.7|-0.7|0.978
72450228|NCT03580356|144419783|SUPERIORITY|Wald chi-square test based on logistic regression|Odds Ratio (OR)|0.838||||0.8524|TWO_SIDED|95.0|0.602|1.167|||Regression, Logistic|95% confidence interval for the odds ratio||Adults only||1.167|0.602|0.8524
72450229|NCT03580356|144419783|SUPERIORITY|Wald chi-square test based on logistic regression|Odds Ratio (OR)|4.542|||<|0.0001|TWO_SIDED|95.0|2.577|8.004|||Regression, Logistic|95% confidence interval for the odds ratio||Adults only||8.004|2.577|<.0001
72450230|NCT03580356|144419783|SUPERIORITY|Wald chi-square test based on logistic regression|Odds Ratio (OR)|1.106||||0.2764|TWO_SIDED|95.0|0.794|1.54|||Regression, Logistic|95% confidence interval for the odds ratio||Adults only||1.540|0.794|0.2764
72450231|NCT03580356|144419784|SUPERIORITY||Risk Ratio (RR)|1.389|||<|0.0001|TWO_SIDED|95.0|1.235|1.561|||Negative binomial regression model|95% confidence interval for the relative risk ratio||Adults only||1.561|1.235|<.0001
72450232|NCT03580356|144419784|SUPERIORITY||Risk Ratio (RR)|1.029||||0.2369|TWO_SIDED|95.0|0.952|1.111|||Negative binomial regression model|95% confidence interval for the relative risk ratio||Adults only||1.111|0.952|0.2369
72619600|NCT02070380|144770026|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon signed-rank test|||"Null hypotheses:~A 0.1 mmol/kg dose of MULTIHANCE is equal to a 0.1 mmol/kg dose of DOTAREM, in terms of the assessment of Extent of Disease in an off-site pre-dose plus postdose paired global assessment."||||<0.0001
72450233|NCT03580356|144419784|SUPERIORITY||Risk Ratio (RR)|1.425|||<|0.0001|TWO_SIDED|95.0|1.268|1.603|||Negative binomial regression model|95% confidence interval for the relative risk ratio||Adults only||1.603|1.268|<.0001
72450234|NCT03580356|144419784|SUPERIORITY||Risk Ratio (RR)|1.056||||0.083|TWO_SIDED|95.0|0.978|1.14|||Negative binomial regression model|95% confidence interval for the relative risk ratio||Adults only||1.140|0.978|0.0830
72450235|NCT05715528|144419786|SUPERIORITY||Hazard Ratio (HR)|1.099||||0.0681|TWO_SIDED|95.0|0.997|1.211||P-value calculated from stratified Log-rank test with randomization stratification factor as the strata.|Stratified Log-rank test||Hazard ratio and two-sided 95% confidence interval (CI) for hazard ratio were estimated using the Cox regression with randomization stratification factor as a covariate.|||1.211|0.997|0.0681
72450236|NCT05715528|144419790|SUPERIORITY||Hazard Ratio (HR)|1.036||||0.5558|TWO_SIDED|95.0|0.935|1.147|||Stratified Log-Rank Test|P-value calculated from stratified Log-rank test with randomization stratification factor as the strata.|Hazard ratio and two-sided 95% CI for hazard ratio were estimated using the Cox regression with randomization stratification factor as a covariate.|||1.147|0.935|0.5558
72450237|NCT05715528|144419791|SUPERIORITY|||||||0.6469|||||||Fisher's exact test|||||||0.6469
72450238|NCT05715528|144419792|SUPERIORITY||Hazard Ratio (HR)|0.495||||0.5581|TWO_SIDED|95.0|0.045|5.464|||Log-rank test|P value was based on log-rank test.|Hazard ratio and two-sided 95% CI were estimated using the Cox regression.|||5.464|0.045|0.5581
72619601|NCT02070380|144770026|SUPERIORITY_OR_OTHER|||||||1|||||||Wilcoxon signed-rank test|||"Null hypotheses:~A 0.05 mmol/kg dose of MULTIHANCE is equal to a 0.1 mmol/kg dose of DOTAREM, in terms of the assessment of Extent of Disease in an off-site pre-dose plus post-dose paired global assessment."||||1.0000
72450239|NCT05715528|144419794|SUPERIORITY||Least Squares Mean|0.02||||0.4254|TWO_SIDED|95.0|-0.03|0.08||p-value was from Mixed-effects model repeated measures (MMRM) with baseline viral load and randomization strata as covariates.|MMRM||95% CI was from MMRM with baseline viral load and randomization strata as covariates.|||0.08|-0.03|0.4254
72450240|NCT05715528|144419795|SUPERIORITY||Hazard Ratio (HR)|1.138||||0.0015|TWO_SIDED|95.0|1.032|1.256||P-value calculated from stratified Log-rank test with randomization stratification factor as the strata.|Stratified Log-rank test||Hazard ratio and two-sided 95% CI for hazard ratio were estimated using the Cox regression with randomization stratification factor as a covariate.|||1.256|1.032|0.0015
72450241|NCT05715528|144419796|SUPERIORITY|||||||0.6978|||||||Fisher's exact test|P-value was from the Fisher's exact test.||||||0.6978
72450242|NCT05715528|144419801|SUPERIORITY|||||||0.5707|||||||Fisher's exact test|P-value was from the Fisher's exact test.||||||0.5707
72450243|NCT03536884|144419815|NON_INFERIORITY|The evaluation of noninferiority is tested at a 1-sided alpha level of 0.025 and based on a 1-sided 97.5% CI and a noninferiority margin of 10%.|Risk Difference (RD)|12.682|||||TWO_SIDED|95.0|5.771|19.592||||||Risk Difference: BKZ-Secukinumab calculated using stratified Cochran-Mantel-Haenszel (CMH).||19.592|5.771|
72450244|NCT03536884|144419815|SUPERIORITY||Odds Ratio (OR)|1.714|||<|0.001|TWO_SIDED|95.0|1.271|2.31||P-values for the comparison of treatment groups are based on the CMH test for the general association.|Cochran-Mantel-Haenszel|||Odds ratio calculated using stratified CMH test with region and prior biologic exposure as stratification variables.||2.310|1.271|<0.001
72450245|NCT03536884|144419816|SUPERIORITY||Odds Ratio (OR)|2.817|||<|0.001|TWO_SIDED|95.0|2.068|3.836||P-values for the comparison of treatment groups are based on the CMH test from the general association. P-values are not controlled for multiplicity and should only be considered descriptively.|Cochran-Mantel-Haenszel|||Odds ratio calculated using stratified CMH test with region and prior biologic exposure as stratification variables.||3.836|2.068|<0.001
72450246|NCT03536884|144419818|SUPERIORITY||Odds Ratio (OR)|2.49|||<|0.001|TWO_SIDED|95.0|1.835|3.377||P-values for the comparison of treatment groups are based on the CMH test from the general association. P-values are not controlled for multiplicity and should only be considered descriptively.|Cochran-Mantel-Haenszel|||Odds ratio calculated using stratified CMH test with region and prior biologic exposure as stratification variables.||3.377|1.835|<0.001
72450247|NCT03536884|144419818|SUPERIORITY||Odds Ratio (OR)|2.168|||<|0.001|TWO_SIDED|95.0|1.511|3.11||P-values for the comparison of treatment groups are based on the CMH test from the general association.|Cochran-Mantel-Haenszel|||Odds ratio calculated using stratified CMH test with region and prior biologic exposure as stratification variables.||3.110|1.511|<0.001
72450248|NCT03536884|144419818|SUPERIORITY||Odds Ratio (OR)|3.243|||<|0.001|TWO_SIDED|95.0|2.103|5.0||P-values for the comparison of treatment groups are based on the CMH test from the general association.|Cochran-Mantel-Haenszel|||Odds ratio calculated using stratified CMH test with region and prior biologic exposure as stratification variables.||5.000|2.103|<0.001
72450249|NCT03314740|144419901|SUPERIORITY||Hazard Ratio (HR)|0.76||||0.265|TWO_SIDED|90.0|0.5|1.14|||cox model|||||1.14|0.5|0.265
72450250|NCT03314740|144419901|SUPERIORITY||Hazard Ratio (HR)|1.03||||0.904|TWO_SIDED|90.0|0.68|1.55|||cox- model|||||1.55|0.68|0.904
72450251|NCT02367040|144419915|SUPERIORITY|PFS was evaluated with the stratified log-rank test. HR and 95% CI were based on stratified Cox Regression Model.|Hazard Ratio (HR)|0.52||||2e-06|TWO_SIDED|95.0|0.393|0.688||1-sided p-value|Log Rank|||At primary completion date||0.688|0.393|0.000002
72450252|NCT02367040|144419915|SUPERIORITY|PFS was evaluated with the stratified log-rank test. HR and 95% CI were based on stratified Cox Regression Model.|Hazard Ratio (HR)|0.557||||3e-06|TWO_SIDED|95.0|0.431|0.722||1-sided p-value|Log Rank|||At 2-year follow-up cut-off date||0.722|0.431|0.000003
72450253|NCT02367040|144419916|SUPERIORITY|P-value from Cochran-Mantel-Haenszel (CMH) test stratified|Difference in ORR|32.99|||<|1e-06|TWO_SIDED|95.0|23.95|42.03||1-sided p-value|Cochran-Mantel-Haenszel|||At primary completion date||42.03|23.95|<0.000001
72450254|NCT02367040|144419916|SUPERIORITY|P-value from Cochran-Mantel-Haenszel (CMH) test stratified|Difference in ORR|30.67|||<|1e-06|TWO_SIDED|95.0|21.63|39.72||1-sided p-value|Cochran-Mantel-Haenszel|||At 2-year follow-up cut-off date||39.72|21.63|<0.000001
72450255|NCT02367040|144419917|SUPERIORITY|P-value from Cochran-Mantel-Haenszel (CMH) test stratified|Difference in CRR|19.27|||<|1e-06|TWO_SIDED|95.0|11.57|26.96||1-sided p-value|Cochran-Mantel-Haenszel|||At primary completion date||26.96|11.57|<0.000001
72450256|NCT02367040|144419917|SUPERIORITY|P-value from Cochran-Mantel-Haenszel (CMH) test stratified|Difference in CRR|18.92||||1e-06|TWO_SIDED|95.0|11.11|26.73||1-sided p-value|Cochran-Mantel-Haenszel|||At 2-year follow-up cut-off date||26.73|11.11|0.000001
72450257|NCT02367040|144419918|SUPERIORITY|DOR was evaluated with the stratified log-rank test. HR and 95% CI were based on stratified Cox Regression Model.|Kaplan-Meier estimates|0.7||||0.030371|TWO_SIDED|95.0|0.481|1.018||1-sided p-value|Log Rank|||At primary completion date||1.018|0.481|0.030371
72450258|NCT02367040|144419918|SUPERIORITY|DOR was evaluated with the stratified log-rank test. HR and 95% CI were based on stratified Cox Regression Model.|Hazard Ratio (HR)|0.761||||0.051976|TWO_SIDED|95.0|0.547|1.059||1-sided p-value|Log Rank|||At 2-year follow-up cut-off date||1.059|0.547|0.051976
72450259|NCT02367040|144419919|SUPERIORITY|P-value from Cochran-Mantel-Haenszel (CMH) test stratified|Difference in DCR|4.43||||0.097339|TWO_SIDED|95.0|-2.26|11.12||1-sided p-value|Cochran-Mantel-Haenszel|||At primary completion date||11.12|-2.26|0.097339
72450260|NCT02367040|144419919|SUPERIORITY|P-value from Cochran-Mantel-Haenszel (CMH) test stratified|Difference in DCR|4.43||||0.097339|TWO_SIDED|95.0|-2.26|11.12||1-sided p-value|Cochran-Mantel-Haenszel|||At 2-year follow-up cut-off date||11.12|-2.26|0.097339
72450261|NCT02367040|144419920|SUPERIORITY|TTP was evaluated with the stratified log-rank test. HR and 95% CI were based on Cox Regression Model.|Hazard Ratio (HR)|0.476|||<|1e-06|TWO_SIDED|95.0|0.357|0.635||1-sided p-value|Log Rank|||At primary completion date||0.635|0.357|<.000001
72498952|NCT00348140|144528169|SUPERIORITY||Mean Difference (Net)|0.2||||0.691|TWO_SIDED|95.0|-0.6|1.0|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|For Week 36||1.0|-0.6|0.691
72619602|NCT02070380|144770026|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon signed-rank test|||"Null hypotheses:~A 0.1 mmol/kg dose of MULTIHANCE is equal to a 0.1 mmol/kg dose of DOTAREM, in terms of the assessment of Extent of Disease in an off-site pre-dose plus postdose paired global assessment."||||<0.0001
72450262|NCT02367040|144419920|SUPERIORITY|TTP was evaluated with the stratified log-rank test. HR and 95% CI were based on Cox Regression Model.|Hazard Ratio (HR)|0.505|||<|1e-06|TWO_SIDED|95.0|0.387|0.659||1-sided p-value|Log Rank|||At 2-year follow-up cut-off date||0.659|0.387|<.000001
72450263|NCT02367040|144419922|SUPERIORITY|Time to deterioration in DRS-P was evaluated with the stratified log-rank test. HR and 95% CI were based on Cox Regression Model.|Hazard Ratio (HR)|1.06||||0.69261|TWO_SIDED|95.0|0.843|1.331||1-sided p-value|Log Rank|||At primary completion date||1.331|0.843|0.692610
72450264|NCT02367040|144419922|SUPERIORITY|Time to deterioration in DRS-P was evaluated with the stratified log-rank test. HR and 95% CI were based on Cox Regression Model.|Hazard Ratio (HR)|1.047||||0.661145|TWO_SIDED|95.0|0.841|1.302||1-sided p-value|Log Rank|||At 2-year follow-up cut-off date||1.302|0.841|0.661145
72450265|NCT02367040|144419923|SUPERIORITY|Time to improvement in DRS-P was evaluated with the stratified log-rank test. HR and 95% CI were based on Cox Regression Model.|Hazard Ratio (HR)|0.996||||0.510038|TWO_SIDED|95.0|0.732|1.355||1-sided p-value|Log Rank|||At primary completion date||1.355|0.732|0.510038
72450266|NCT02367040|144419923|SUPERIORITY|Time to improvement in DRS-P was evaluated with the stratified log-rank test. HR and 95% CI were based on Cox Regression Model.|Hazard Ratio (HR)|1.036||||0.40597|TWO_SIDED|95.0|0.768|1.398||1-sided p-value|Log Rank|||At 2-year follow-up cut-off date||1.398|0.768|0.405970
72450267|NCT04934072|144419955|NON_INFERIORITY|Non-inferiority of FKS518 to US-Prolia was demonstrated if the 90% CI for the difference in mean percent change from baseline to Week 52 in LS-BMD laid entirely above -1.45%.|Mean Difference (Final Values)|0.46|STANDARD_ERROR_OF_MEAN|0.306|||TWO_SIDED|90.0|-0.05|0.96|||||Difference : FKS518 - US-Prolia|||0.96|-0.05|
72450268|NCT04934072|144419955|OTHER|Non-superiority Analysis: Non-superiority of FKS518 to US-Prolia was demonstrated if the 90% CI for the difference in mean percent change from baseline to Week 52 in LS-BMD laid entirely below 1.45%.|Mean Difference (Final Values)|0.69|STANDARD_ERROR_OF_MEAN|0.306|||TWO_SIDED|90.0|0.19|1.2|||||Difference : FKS518 - US-Prolia|||1.20|0.19|
72450269|NCT03421340|144419978|NON_INFERIORITY|Non-Inferiority Margin of 10%|Risk Difference (RD)|1.8||||0.029|TWO_SIDED||||||exact|||||||0.029
72450270|NCT03421340|144419979|SUPERIORITY|Not powered|Risk Difference (RD)|-1.7|||||TWO_SIDED|95.0|-8.0|4.1||||||||4.1|-8|
72450271|NCT03421340|144419980|SUPERIORITY||Median Difference (Net)|133.0|||||TWO_SIDED|95.0|120.0|143.0||||||||143|120|
72450272|NCT03421340|144419981|SUPERIORITY||Median Difference (Final Values)|-10.2|||||TWO_SIDED|95.0|-11.6|-7.5||||||||-7.5|-11.6|
72450273|NCT05736458|144420012|SUPERIORITY||Mean Difference (Final Values)|0.45||||0.66|TWO_SIDED||||||t-test, 2 sided|||Of the 23 participants who completed all study procedures, 2 participant's data was unusable for this analysis. Statistics are from paired 2 tailed t-test comparing pre-rTMS 2-back percent accuracy scores for participant's high and low controllability target.||||0.66
72498953|NCT00348140|144528169|SUPERIORITY||Mean Difference (Net)|-0.1||||0.849|TWO_SIDED|95.0|-0.9|0.8|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|For Week 36||0.8|-0.9|0.849
72450274|NCT05736458|144420013|SUPERIORITY||Mean Difference (Final Values)|1.94||||0.43|TWO_SIDED||||||t-test, 2 sided|df = 19||Statistics are from 2-tailed t-test comparing pre-rTMS to post-rTMS 2-back accuracy scores for a high controllability TMS target. Alternative hypothesis: true mean is not equal to 0.||||0.43
72450275|NCT05736458|144420013|SUPERIORITY||Mean Difference (Final Values)|6.36|||<|0.04|TWO_SIDED||||||t-test, 2 sided|df = 20||Statistics are from 2-tailed t-test comparing pre-rTMS and post-rTMS 2-back percent accuracy scores for a low controllability TMS target. Alternative hypothesis: true mean is not equal to 0.||||<0.04
72450276|NCT05736458|144420014|SUPERIORITY||Mean Difference (Final Values)|11.54|||<|0.05|TWO_SIDED||||||t-test, 2 sided|df = 11||Statistics are from 2-tailed paired t-test comparing 2-back accuracy score before and after rTMS to a high controllability target. Alternative hypothesis: true mean is not equal to 0.||||<0.05
72450277|NCT05736458|144420015|SUPERIORITY||Mean Difference (Net)|-4.42||||0.27|TWO_SIDED||||||t-test, 2 sided|df = 19||Statistics are from paired 2 tailed t-test comparing 2-back percent changes (Post-rTMS - pre-rTMS) scores for participant's high and low controllability target. Alternative hypothesis: true mean is not equal to 0.||||0.27
72450278|NCT02990338|144420016|SUPERIORITY|A closed test procedure was used to control the type I error rate meaning no further testing would be performed unless the significance level had been reached on PFS.|Hazard Ratio (HR)|0.596||||0.0005|TWO_SIDED|95.0|0.436|0.814||One-sided p-value based on Stratified log-rank test. Threshold for statistical significance at 0.025.|Log Rank|Stratification was based on age (\<75 years versus \>=75 years) and number of previous lines of therapy (2 or 3 versus \>3) according to IRT.|Stratification was based on age (\<75 years versus \>=75 years) and number of previous lines of therapy (2 or 3 versus \>3) according to IRT.|Confidence interval (CI) for Kaplan-Meier estimates were calculated with log-log transformation of survival function and methods of Brookmeyer and Crowley.||0.814|0.436|0.0005
72450279|NCT02990338|144420017|SUPERIORITY|A closed test procedure was used to control the type I error rate meaning no further testing would be performed unless the significance level had been reached on PFS.|||||<|0.0001||||||Threshold for statistical significance at 0.025.|Cochran-Mantel-Haenszel|One sided p-value was stratified based on age (\<75 years versus \>=75 years) and number of previous lines (2 or 3 versus \>3) according to IRT.||||||<0.0001
72450280|NCT02990338|144420021|SUPERIORITY|A closed test procedure was used to control the type I error rate meaning no further testing would be performed unless the significance level had been reached on PFS.|Hazard Ratio (HR)|0.776||||0.0319|TWO_SIDED|95.0|0.594|1.015||One-sided significance level was 0.02 using the O'Brien-Fleming alpha spending function.|Log Rank|Stratified on age (\<75 years versus \>=75 years) and number of previous lines of therapy (2 or 3 versus \> 3) according to IRT.|Stratified on age (\<75 years versus \>=75 years) and number of previous lines of therapy (2 or 3 versus \> 3) according to IRT.|||1.015|0.594|0.0319
72450281|NCT02865538|144420103|OTHER|Descriptive Analysis|LS means difference|0.09|STANDARD_ERROR_OF_MEAN|0.127||0.4641|TWO_SIDED|90.0|-0.12|0.3|||Linear mixed-effects model||Change from Week -1 to Week 1|||0.30|-0.12|0.4641
72450282|NCT02865538|144420103|OTHER|Descriptive Analysis|Linear mixed-effects model|0.0|STANDARD_ERROR_OF_MEAN|0.128||0.9894|TWO_SIDED|90.0|-0.21|0.21|||LS means difference||Change from Week -1 to Week 1|||0.21|-0.21|0.9894
72450283|NCT02865538|144420103|OTHER|Descriptive Analysis|LS means difference|-0.31|STANDARD_ERROR_OF_MEAN|0.129||0.0199|TWO_SIDED|90.0|-0.52|-0.09|||Linear mixed-effects model||Change from Week -1 to Week 1|||-0.09|-0.52|0.0199
72561898|NCT03259789|144654652|SUPERIORITY||Difference of LS Means|-1.35|||<|0.0001|TWO_SIDED|95.0|-1.83|-0.86|||Mixed-effects repeated measures|Mixed-effects repeated measures analysis includes country, treatment, visit, treatment and baseline HbA1c value as fixed effect covariates||||-0.86|-1.83|< 0.0001
72450284|NCT02865538|144420103|OTHER|Descriptive Analysis|LS means difference|-0.12|STANDARD_ERROR_OF_MEAN|0.133||0.3907|TWO_SIDED|90.0|-0.34|0.11|||Linear mixed-effects model||Change from Week -1 to Week 1|||0.11|-0.34|0.3907
72450285|NCT02865538|144420103|OTHER|Descriptive Analysis|LS means difference|0.1|STANDARD_ERROR_OF_MEAN|0.166||0.5393|TWO_SIDED|90.0|-0.17|0.38|||Linear mixed-effects model||Change from Week -1 to Week 2|||0.38|-0.17|0.5393
72450286|NCT02865538|144420103|OTHER|Descriptive Analysis|LS means difference|-0.04|STANDARD_ERROR_OF_MEAN|0.169||0.7931|TWO_SIDED|90.0|-0.33|0.24|||Linear mixed-effects model||Change from Week -1 to Week 2|||0.24|-0.33|0.7931
72450287|NCT02865538|144420103|OTHER|Descriptive Analysis|LS means difference|-0.63|STANDARD_ERROR_OF_MEAN|0.169||0.0004|TWO_SIDED|90.0|-0.92|-0.35|||Linear mixed-effects model||Change from Week -1 to Week 2|||-0.35|-0.92|0.0004
72450288|NCT02865538|144420103|OTHER|Descriptive Analysis|LS means difference|-0.16|STANDARD_ERROR_OF_MEAN|0.175||0.3739|TWO_SIDED|90.0|-0.45|0.13|||Linear mixed-effects model||Change from Week -1 to Week 2|||0.13|-0.45|0.3739
72450289|NCT02865538|144420104|OTHER|Descriptive Analysis|LS means difference|5.29|STANDARD_ERROR_OF_MEAN|3.077||0.09|TWO_SIDED|90.0|0.16|10.42|||Linear mixed-effects model||Change from Week -1 to Week 1|||10.42|0.16|0.0900
72450290|NCT02865538|144420104|OTHER|Descriptive Analysis|LS means difference|-4.46|STANDARD_ERROR_OF_MEAN|3.053||0.1487|TWO_SIDED|90.0|-9.55|0.63|||Linear mixed-effects model||Change from Week -1 to Week 1|||0.63|-9.55|0.1487
72450291|NCT02865538|144420104|OTHER|Descriptive Analysis|LS means difference|-10.18|STANDARD_ERROR_OF_MEAN|3.015||0.0012|TWO_SIDED|90.0|-15.2|-5.15|||Linear mixed-effects model||Change from Week -1 to Week 1|||-5.15|-15.20|0.0012
72450292|NCT02865538|144420104|OTHER|Descriptive Analysis|LS means difference|-6.14|STANDARD_ERROR_OF_MEAN|3.142||0.0548|TWO_SIDED|90.0|-11.37|-0.9|||Linear mixed-effects model||Change from Week -1 to Week 1|||-0.90|-11.37|0.0548
72561899|NCT03259789|144654654|SUPERIORITY||Difference of LS Means|-7.07|||<|0.0001|TWO_SIDED|95.0|-9.83|-4.32|||Mixed-effects repeated measures|Mixed-effects repeated measures analysis includes country, treatment, visit, treatment and baseline HbA1c value as fixed effect covariates||||-4.32|-9.83|< 0.0001
72561900|NCT03259789|144654655|SUPERIORITY||Odds Ratio (OR)|4.69||||0.0014|TWO_SIDED|95.0|1.7|12.95||P-value is presented based on one-sided statistical tests using a 0.025 level of significance|Mixed-effects repeated measures|Mixed-effects repeated measures analysis includes country, treatment, visit, treatment and baseline HbA1c value as fixed effect covariates|The odds ratios of bexagliflozin group over the placebo group at each visit will be estimated from LS means based on the model with the corresponding p-values and their two-sided 95% CIs presented.|Odds ratio at Week 6 was calculated as the odds ratio of bexagliflozin group over placebo group.||12.95|1.70|0.0014
72450293|NCT02865538|144420104|OTHER|Descriptive Analysis|LS means difference|6.59|STANDARD_ERROR_OF_MEAN|3.337||0.0522|TWO_SIDED|90.0|1.03|12.15|||Linear mixed-effects model||Change from Week -1 to Week 2|||12.15|1.03|0.0522
72450294|NCT02865538|144420104|OTHER|Descriptive Analysis|LS means difference|-5.07|STANDARD_ERROR_OF_MEAN|3.329||0.1326|TWO_SIDED|90.0|-10.61|0.48|||Linear mixed-effects model||Change from Week -1 to Week 2|||0.48|-10.61|0.1326
72450295|NCT02865538|144420104|OTHER|Descriptive Analysis|LS means difference|-12.28|STANDARD_ERROR_OF_MEAN|3.27||0.0004|TWO_SIDED|90.0|-17.73|-6.83|||Linear mixed-effects model||Change from Week -1 to Week 2|||-6.83|-17.73|0.0004
72450296|NCT02865538|144420104|OTHER|Descriptive Analysis|LS means difference|-7.79|STANDARD_ERROR_OF_MEAN|3.408||0.0253|TWO_SIDED|90.0|-13.47|-2.11|||Linear mixed-effects model||Change from Week -1 to Week 2|||-2.11|-13.47|0.0253
72450297|NCT02865538|144420105|OTHER|Descriptive Analysis|LS means difference|1.4|STANDARD_ERROR_OF_MEAN|1.58||0.3796|TWO_SIDED|90.0|-1.2|4.0|||Linear mixed-effects model||Day 7 Change from Day -1|||4.0|-1.2|0.3796
72450298|NCT02865538|144420105|OTHER|Descriptive Analysis|LS means difference|-2.3|STANDARD_ERROR_OF_MEAN|1.55||0.1413|TWO_SIDED|90.0|-4.9|0.3|||Linear mixed-effects model||Day 7 Change from Day -1|||0.3|-4.9|0.1413
72450299|NCT02865538|144420105|OTHER|Descriptive Analysis|LS means difference|-5.5|STANDARD_ERROR_OF_MEAN|1.55||0.0007|TWO_SIDED|90.0|-8.1|-2.9|||Linear mixed-effects model||Day 7 Change from Day -1|||-2.9|-8.1|0.0007
72450300|NCT02865538|144420105|OTHER|Descriptive Analysis|LS means difference|-3.1|STANDARD_ERROR_OF_MEAN|1.62||0.0624|TWO_SIDED|90.0|-5.8|-0.4|||Linear mixed-effects model||Day 7 Change from Day -1|||-0.4|-5.8|0.0624
72450301|NCT02865538|144420105|OTHER|Descriptive Analysis|LS means difference|1.3|STANDARD_ERROR_OF_MEAN|1.21||0.293|TWO_SIDED|90.0|-0.7|3.3|||Linear mixed-effects model||Day 14 Change from Day -1|||3.3|-0.7|0.2930
72450302|NCT02865538|144420105|OTHER|Descriptive Analysis|LS means difference|-2.4|STANDARD_ERROR_OF_MEAN|1.21||0.0512|TWO_SIDED|90.0|-4.4|-0.4|||Linear mixed-effects model||Day 14 Change from Day -1|||-0.4|-4.4|0.0512
72450303|NCT02865538|144420105|OTHER|Descriptive Analysis|LS means difference|-5.0|STANDARD_ERROR_OF_MEAN|1.2|<|0.0001|TWO_SIDED|90.0|-7.0|-3.0|||Linear mixed-effects model||Day 14 Change from Day -1|||-3.0|-7.0|<0.0001
72450304|NCT02865538|144420105|OTHER|Descriptive Analysis|LS means difference|-3.4|STANDARD_ERROR_OF_MEAN|1.25||0.008|TWO_SIDED|90.0|-5.5|-1.3|||Linear mixed-effects model||Day 14 Change from Day -1|||-1.3|-5.5|0.0080
72619603|NCT02070380|144770026|SUPERIORITY_OR_OTHER|||||||1|||||||Wilcoxon signed-rank test|||"Null hypotheses:~A 0.05 mmol/kg dose of MULTIHANCE is equal to a 0.1 mmol/kg dose of DOTAREM, in terms of the assessment of Extent of Disease in an off-site pre-dose plus postdose paired global assessment."||||1.0000
72450305|NCT02865538|144420106|OTHER|Descriptive Analysis|LS means difference|0.84|STANDARD_ERROR_OF_MEAN|0.574||0.1482|TWO_SIDED|90.0|-0.12|1.8|||Linear mixed-effects model||Change from Week -1 to Week 1|||1.80|-0.12|0.1482
72450306|NCT02865538|144420106|OTHER|Descriptive Analysis|LS means difference|-1.04|STANDARD_ERROR_OF_MEAN|0.571||0.0734|TWO_SIDED|90.0|-1.99|-0.09|||Linear mixed-effects model||Change from Week -1 to Week 1|||-0.09|-1.99|0.0734
72450307|NCT02865538|144420106|OTHER|Descriptive Analysis|LS means difference|-1.8|STANDARD_ERROR_OF_MEAN|0.565||0.0022|TWO_SIDED|90.0|-2.74|-0.86|||Linear mixed-effects model||Change from Week -1 to Week 1|||-0.86|-2.74|0.0022
72450308|NCT02865538|144420106|OTHER|Descriptive Analysis|LS means difference|-1.1|STANDARD_ERROR_OF_MEAN|0.589||0.066|TWO_SIDED|90.0|-2.08|-0.12|||Linear mixed-effects model||Change from Week -1 to Week 1|||-0.12|-2.08|0.0660
72450309|NCT02865538|144420106|OTHER|Descriptive Analysis|LS means difference|1.18|STANDARD_ERROR_OF_MEAN|0.613||0.0593|TWO_SIDED|90.0|0.15|2.2|||Linear mixed-effects model||||Change from Week -1 to Week 2|2.20|0.15|0.0593
72450310|NCT02865538|144420106|OTHER||LS means difference|-0.93|STANDARD_ERROR_OF_MEAN|0.614||0.1354|TWO_SIDED|90.0|-1.95|0.1|||Linear mixed-effects model||Change from Week -1 to Week 2|||0.10|-1.95|0.1354
72450311|NCT02865538|144420106|OTHER|Descriptive Analysis|LS means difference|-2.2|STANDARD_ERROR_OF_MEAN|0.603||0.0005|TWO_SIDED|90.0|-3.21|-1.2|||Linear mixed-effects model||Change from Week -1 to Week 2|||-1.20|-3.21|0.0005
72450312|NCT02865538|144420106|OTHER|Descriptive Analysis|LS means difference|-1.38|STANDARD_ERROR_OF_MEAN|0.628||0.0309|TWO_SIDED|90.0|-2.43|-0.34|||Linear mixed-effects model||Change from Week -1 to Week 2|||-0.34|-2.43|0.0309
72450313|NCT02865538|144420107|OTHER|Descriptive analysis|LS means difference|-9.7|STANDARD_ERROR_OF_MEAN|10.88||0.3768|TWO_SIDED|90.0|-27.8|8.5|||Linear mixed-effects model||Change from Day -1 to Day 1|||8.5|-27.8|0.3768
72450314|NCT02865538|144420107|OTHER|Descriptive analysis|LS means difference|-25.0|STANDARD_ERROR_OF_MEAN|10.89||0.0248|TWO_SIDED|90.0|-43.1|-6.8|||Linear mixed-effects model||Change from Day -1 to Day 1|||-6.8|-43.1|0.0248
72450315|NCT02865538|144420107|OTHER|Descriptive analysis|LS means difference|-43.9|STANDARD_ERROR_OF_MEAN|10.9||0.0001|TWO_SIDED|90.0|-62.1|-25.8|||Linear mixed-effects model||Change from Day -1 to Day 1|||-25.8|-62.1|0.0001
72450316|NCT02865538|144420107|OTHER|Descriptive analysis|LS means difference|-42.9|STANDARD_ERROR_OF_MEAN|11.43||0.0004|TWO_SIDED|90.0|-61.9|-23.8|||Linear mixed-effects model||Change from Day -1 to Day 1|||-23.8|-61.9|0.0004
72450317|NCT02865538|144420107|OTHER|Descriptive analysis|LS means difference|10.4|STANDARD_ERROR_OF_MEAN|14.76||0.4819|TWO_SIDED|90.0|-14.2|35.1|||Linear mixed-effects model||Change from Day -1 to Day 7|||35.1|-14.2|0.4819
72450318|NCT02865538|144420107|OTHER|Descriptive analysis|LS means difference|-2.4|STANDARD_ERROR_OF_MEAN|14.77||0.8694|TWO_SIDED|90.0|-27.1|22.2|||Linear mixed-effects model||Change from Day -1 to Day 7|||22.2|-27.1|0.8694
72450319|NCT02865538|144420107|OTHER|Descriptive analysis|LS means difference|-23.9|STANDARD_ERROR_OF_MEAN|14.79||0.1105|TWO_SIDED|90.0|-48.6|0.7|||Linear mixed-effects model||Change from Day -1 to Day 7|||0.7|-48.6|0.1105
72450320|NCT02865538|144420107|OTHER|Descriptive analysis|LS means difference|-18.4|STANDARD_ERROR_OF_MEAN|15.5||0.239|TWO_SIDED|90.0|-44.2|7.4|||Linear mixed-effects model||Change from Day -1 to Day 7|||7.4|-44.2|0.2390
72469694|NCT03635086|144463054|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|1.3||||0.9942|TWO_SIDED|95.0|0.2|6.4|||ANOVA|||Day 365||6.4|0.2|0.9942
72469695|NCT03635086|144463054|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|2.5||||0.4932|TWO_SIDED|95.0|0.5|12.9|||ANOVA|||Day 365||12.9|0.5|0.4932
72450321|NCT03106740|144420108|SUPERIORITY|Because relevant \[11C\]PBR28 PET imaging data were unavailable at the time of trial initiation to inform a power analysis of a treatment effect, we ran a power analysis of the treatment effect on the expected change in pain ratings based on a recent clinical trial using minocycline in subjects with back pain. We computed the sample size required for mixed effects between-subject and within-subject (Time: Pretest/Posttest) repeated measures ANOVA design. Alpha was set at 0.05 (two-tailed test).|Restricted maximum likelihood|0.0||||0.956|TWO_SIDED|95.0|-0.02|0.02||The p-value corresponds to the group-by-time interaction analysis of the primary outcome measure.|Mixed Models Analysis||Estimation parameter: Unstandardized partial regression coefficient (beta)|||0.02|-0.02|0.956
72450322|NCT04797858|144420116|SUPERIORITY||Risk Difference (RD)|0.0077||||0.45|TWO_SIDED|95.0|-0.021|0.056|||Fisher Exact|||||0.056|-0.021|0.45
72450323|NCT04797858|144420117|SUPERIORITY||Risk Difference (RD)|0.015||||0.11|TWO_SIDED|95.0|-0.0004|0.03|||Fisher Exact|||||0.03|-0.0004|0.11
72450324|NCT05423730|144420132|SUPERIORITY||Mean Difference (Final Values)|-11.12|||||TWO_SIDED|95.0|-49.75|57.2|||||Estimates represent percentage change in log-transformed hormone levels for wine versus grape juice from linear mixed models including participant as a random effect and interaction terms for drink and sequence (Kenward approach).|||57.20|-49.75|
72450325|NCT05423730|144420133|SUPERIORITY||Mean Difference (Final Values)|7.65|||||TWO_SIDED|95.0|-47.96|63.9|||||Estimates represent percentage change in log-transformed hormone levels for wine versus grape juice from linear mixed models including participant as a random effect and interaction terms for drink and sequence (Kenward approach).|||63.90|-47.96|
72450326|NCT05423730|144420134|SUPERIORITY||Mean Difference (Final Values)|-0.65|||||TWO_SIDED|95.0|-1.95|0.67|||||Estimates represent percentage change in log-transformed hormone levels for wine versus grape juice from linear mixed models including participant as a random effect and interaction terms for drink and sequence (Kenward approach).|||0.67|-1.95|
72450327|NCT05423730|144420135|SUPERIORITY||Mean Difference (Final Values)|13.83|||||TWO_SIDED|95.0|-9.45|43.09|||||Estimates represent percentage change in log-transformed hormone levels for wine versus grape juice from linear mixed models including participant as a random effect and interaction terms for drink and sequence (Kenward approach).|||43.09|-9.45|
72450328|NCT05423730|144420136|SUPERIORITY||Mean Difference (Final Values)|11.42|||||TWO_SIDED|95.0|-3.31|28.4|||||Estimates represent percentage change in log-transformed hormone levels for wine versus grape juice from linear mixed models including participant as a random effect and interaction terms for drink and sequence (Kenward approach).|||28.40|-3.31|
72450329|NCT05423730|144420137|SUPERIORITY||Mean Difference (Final Values)|12.57|||||TWO_SIDED|95.0|-0.77|27.69|||||Estimates represent percentage change in log-transformed hormone levels for wine versus grape juice from linear mixed models including participant as a random effect and interaction terms for drink and sequence (Kenward approach).|||27.69|-0.77|
72619604|NCT02070380|144770026|SUPERIORITY_OR_OTHER|||||||0.0023|||||||Wilcoxon signed-rank test|||"Null hypotheses:~A 0.1 mmol/kg dose of MULTIHANCE is equal to a 0.1 mmol/kg dose of DOTAREM, in terms of the assessment of Extent of Disease in an off-site pre-dose plus postdose paired global assessment."||||0.0023
72450330|NCT05423730|144420138|SUPERIORITY||Mean Difference (Final Values)|-2.7|||||TWO_SIDED|95.0|-21.92|21.24|||||Estimates represent percentage change in log-transformed hormone levels for wine versus grape juice from linear mixed models including participant as a random effect and interaction terms for drink and sequence (Kenward approach).|||21.24|-21.92|
72450331|NCT05363163|144420144|OTHER|If the mean volume variation was higher than 0 and the p-value of the statistical test lower than 0.05, the H0 hypothesis was rejected, and the primary endpoint demonstrated.|||||<|0.0001||||||p-value of the statistical test lower than 0.05|t-test, 2 sided|||||||<0.0001
72450332|NCT03673501|144420151|SUPERIORITY||Hazard Ratio (HR)|0.88||||0.3598|TWO_SIDED|95.0|0.66|1.16|||Log Rank|Strata: by intolerance to imatinib treatment||||1.16|0.66|0.3598
72450333|NCT03673501|144420152|SUPERIORITY||Hazard Ratio (HR)|1.05||||0.7153|TWO_SIDED|95.0|0.82|1.33||Two-sided P-value|Log Rank|Strata: mutation status (KIT exon 9 vs. 11 vs. KIT/PDGFRA WT vs. other KIT {absence of exon 9 or 11}/PDGFRA) and intolerance to imatinib treatment||||1.33|0.82|0.7153
72450334|NCT03673501|144420153|SUPERIORITY|||||||0.0333|||||||Cochran-Mantel-Haenszel|Strata: intolerance to imatinib treatment||||||0.0333
72450335|NCT03673501|144420154|SUPERIORITY|||||||0.2681|||||||Cochran-Mantel-Haenszel|Strata: mutation status (KIT exon 9 vs. 11 vs. KIT/PDGFRA WT vs. other KIT {absence of exon 9 or 11}/PDGFRA) and intolerance to imatinib treatment||||||0.2681
72450336|NCT03673501|144420155|SUPERIORITY||Hazard Ratio (HR)|1.05||||0.7733|TWO_SIDED|95.0|0.75|1.48|||Log Rank|Strata: intolerance to imatinib treatment||||1.48|0.75|0.7733
72450337|NCT03673501|144420156|SUPERIORITY||Hazard Ratio (HR)|0.88||||0.3928|TWO_SIDED|95.0|0.66|1.18|||Log Rank|Strata: mutation status (KIT exon 9 vs. 11 vs. KIT/PDGFRA WT vs. other KIT {absence of exon 9 or 11}/PDGFRA) and intolerance to imatinib||||1.18|0.66|0.3928
72469696|NCT03635086|144463054|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|0.8||||0.9983|TWO_SIDED|95.0|0.2|4.6|||ANOVA|||Day 365||4.6|0.2|0.9983
72469697|NCT03635086|144463054|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|1.7||||0.9112|TWO_SIDED|95.0|0.3|9.3|||ANOVA|||Day 365||9.3|0.3|0.9112
72469698|NCT03635086|144463054|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|2.0||||0.7431|TWO_SIDED|95.0|0.4|10.2|||ANOVA|||Day 365||10.2|0.4|0.7431
72469699|NCT00513747|144463082|SUPERIORITY|||||||0.1521|||||||Log Rank|||||||0.1521
72469700|NCT00513747|144463083|SUPERIORITY|||||||0.0097|||||||Log Rank|||||||0.0097
72469701|NCT00513747|144463084|SUPERIORITY|||||||0.4645|||||||Log Rank|||||||0.4645
72469702|NCT02781311|144463105|SUPERIORITY||Least-squares Mean Difference|0.4|STANDARD_ERROR_OF_MEAN|4.45||0.9239|TWO_SIDED|95.0|-8.38|9.23||P-values were from analysis of covariance (ANCOVA) model including fixed effects of treatment, and covariates of age and baseline TAHC value, with the Type III sum of squares.|ANCOVA|||||9.23|-8.38|0.9239
72469703|NCT02781311|144463106|SUPERIORITY||Least-squares Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.2||0.9101|TWO_SIDED|95.0|-0.42|0.37||P-values were from analysis of covariance (ANCOVA) model including fixed effects of treatment, and covariates of age, with the Type III sum of squares.|ANCOVA|||||0.37|-0.42|0.9101
72450338|NCT03550170|144420157|NON_INFERIORITY|Non-inferiority was established using the prespecified margin of inferiority of 10 points on the total composite score of the Fatigue Impact Scale.|Slope|4.89|STANDARD_ERROR_OF_MEAN|2.57|||TWO_SIDED|90.0|0.67|9.11|||||Comparison of teleconference to one-to-one at 6 months.|A generalized estimating equation (GEE) served as the primary analysis tool for modeling the longitudinal scores of the primary outcome - Fatigue Impact Scale (FIS).||9.11|0.67|
72450339|NCT03550170|144420157|NON_INFERIORITY|Non-inferiority was established using the prespecified margin of inferiority of 10 points on the total composite score of the Fatigue Impact Scale.|Slope|6.12|STANDARD_ERROR_OF_MEAN|2.62|||TWO_SIDED|90.0|0.98|11.26|||||Comparison of internet to one-to-one at 6 months.|A generalized estimating equation (GEE) served as the primary analysis tool for modeling the longitudinal scores of the primary outcome - Fatigue Impact Scale (FIS).||11.26|0.98|
72450340|NCT03550170|144420158|SUPERIORITY|||||||0.1|||||||ANOVA|||||||0.10
72450341|NCT05683340|144420162|SUPERIORITY||Least squares mean difference|-21.78|STANDARD_ERROR_OF_MEAN|2.482||0.001|TWO_SIDED|95.0|-26.71|-16.85|||MMRM||The least squares mean difference was calculated as the value for the ETC-1002 180 mg arm minus the value for the placebo arm.|||-16.85|-26.71|0.001
72450342|NCT02056834|144420200|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0166|||||||t-test, 2 sided|||Paired T-Test p-value tests the significance of the percent change from baseline within each treatment group.||||0.0166
72450343|NCT02056834|144420201|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3785|||||||t-test, 2 sided|||Paired T-Test p-value tests the significance of the percent change from baseline within each treatment group.||||0.3785
72450344|NCT02056834|144420202|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||t-test, 2 sided|||Paired T-Test p-value tests the significance of the change from baseline within treatment group.||||<0.0001
72619605|NCT02070380|144770026|SUPERIORITY_OR_OTHER|||||||1|||||||Wilcoxon signed-rank test|||"Null hypotheses:~A 0.05 mmol/kg dose of MULTIHANCE is equal to a 0.1 mmol/kg dose of DOTAREM, in terms of the assessment of Extent of Disease in an off-site pre-dose plus postdose paired global assessment."||||1.0000
72450345|NCT02056834|144420203|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||t-test, 2 sided|||Paired T-Test p-value tests the significance of the change from baseline within treatment group.||||<0.0001
72450346|NCT06193070|144420217|OTHER|A one-tailed paired t-test was run to examine within subject mean difference on the cancer nutrition information beliefs scale pre- and post-game.|||||<|0.001||||||The threshold was set at alpha \< 0.05.|t-test, 1 sided|A paired samples t-test was run on pre- and post-game mean scores within subjects.||All participants were exposed to the intervention, and pre- and post-game scores within subject were examined.||||<.001
72450347|NCT03583333|144420223|NON_INFERIORITY|Non-inferiority margin for the difference in mortality (IMI/REL minus PIP/TAZ) was 12.5%.|Adjusted difference in percentage|5.2||||0.024|TWO_SIDED|95.0|-1.5|12.4|||Miettinen & Nurminen method||Adjusted differences and the 95% confidence intervals (CIs) are based on Miettinen \& Nurminen method stratified by randomization stratum.|||12.4|-1.5|0.024
72450348|NCT03583333|144420223|SUPERIORITY||Adjusted difference in percentage|5.2||||0.938|TWO_SIDED|95.0|-1.5|12.4|||Miettinen & Nurminen|Adjusted differences and the 95% CIs are based on Miettinen \& Nurminen method stratified by randomization stratum.||||12.4|-1.5|0.938
72450349|NCT03583333|144420224|OTHER||Adjusted difference in percentage|3.1|||||TWO_SIDED|95.0|-8.7|14.9|||||Adjusted differences and the 95% CIs are based on Miettinen \& Nurminen method stratified by randomization stratum.|||14.9|-8.7|
72450350|NCT03583333|144420225|OTHER||Adjusted difference in percentage|2.2|||||TWO_SIDED|95.0|-12.4|16.8|||||Adjusted difference and the 95% CIs are based on Miettinen \& Nurminen method stratified by randomization stratum.|||16.8|-12.4|
72450351|NCT03583333|144420226|OTHER||Adjusted difference in percentage|3.4|||||TWO_SIDED|95.0|-7.6|14.3|||||Adjusted difference and the 95% CIs are based on Miettinen \& Nurminen method stratified by randomization stratum.|||14.3|-7.6|
72450352|NCT03583333|144420227|OTHER||Adjusted difference in percentage|-4.7|||||TWO_SIDED|95.0|-15.8|6.6|||||Adjusted difference and the 95% CIs are based on Miettinen \& Nurminen method stratified by randomization stratum.|||6.6|-15.8|
72450353|NCT03583333|144420228|OTHER||Adjusted difference in percentage|-2.4|||||TWO_SIDED|95.0|-17.8|13.1|||||Adjusted differences and the 95% CIs are based on Miettinen \& Nurminen method stratified by randomization stratum.|||13.1|-17.8|
72450354|NCT03583333|144420229|OTHER||Adjusted difference in percentage|1.4|||||TWO_SIDED|95.0|-16.5|19.8|||||Adjusted difference and the 95% CIs are based on Miettinen \& Nurminen method stratified by randomization stratum.|||19.8|-16.5|
72450355|NCT03583333|144420230|OTHER||Adjusted difference in percentage|-3.1|||||TWO_SIDED|95.0|-19.8|14.4|||||Adjusted difference and the 95% CIs are based on Miettinen \& Nurminen method stratified by randomization stratum.|||14.4|-19.8|
72450356|NCT03583333|144420231|OTHER||Adjusted difference in percentage|2.0|||||TWO_SIDED|95.0|-6.5|10.6|||||Difference and the 95% CIs are based on Miettinen \& Nurminen method stratified by randomization stratum.|||10.6|-6.5|
72619606|NCT02070380|144770027|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon signed-rank test|||"Null hypotheses:~A 0.1 mmol/kg dose of MULTIHANCE is equal to a 0.1 mmol/kg dose of DOTAREM, in terms of the assessment of Lesion Contrast Enhancement in an off-site pre-dose plus postdose paired global assessment."||||<0.0001
72450357|NCT03583333|144420232|OTHER||Adjusted difference in percentage|-4.4|||||TWO_SIDED|95.0|-10.7|1.4|||||Difference and the 95% CIs are based on Miettinen \& Nurminen method stratified by randomization stratum.|||1.4|-10.7|
72450358|NCT03926130|144420233|SUPERIORITY||Risk Difference (RD)|28.7|||<|1e-06|TWO_SIDED|95.0|23.0|34.4|||Cochran-Mantel-Haenszel|||||34.4|23.0|<0.000001
72450359|NCT03926130|144420234|SUPERIORITY||Risk Difference (RD)|25.8|||<|1e-06|TWO_SIDED|95.0|18.8|32.7|||Cochran-Mantel-Haenszel|||||32.7|18.8|<0.000001
72450360|NCT03926130|144420235|SUPERIORITY||Risk Difference (RD)|19.7|||<|1e-06|TWO_SIDED|95.0|13.7|25.6|||Cochran-Mantel-Haenszel|||||25.6|13.7|<0.000001
72450361|NCT03926130|144420236|SUPERIORITY||Risk Difference (RD)|39.1|||<|1e-06|TWO_SIDED|95.0|33.4|44.8|||Cochran-Mantel-Haenszel|||||44.8|33.4|<0.000001
72450362|NCT03926130|144420236|SUPERIORITY||Risk Difference (RD)|2.3||||0.513623|TWO_SIDED|95.0|-4.7|9.3|||Cochran-Mantel-Haenszel|||||9.3|-4.7|0.513623
72450363|NCT03926130|144420237|SUPERIORITY||Risk Difference (RD)|12.4||||0.001431|TWO_SIDED|95.0|5.3|19.6|||Cochran-Mantel-Haenszel|||||19.6|5.3|0.001431
72450364|NCT03926130|144420238|SUPERIORITY||Risk Difference (RD)|34.6|||<|1e-06|TWO_SIDED|95.0|27.7|41.4|||Cochran-Mantel-Haenszel|||||41.4|27.7|<0.000001
72450365|NCT03926130|144420238|NON_INFERIORITY|The non-inferiority margin is 10%. We do not have power calculation in the SAP for this endpoint.|Risk Difference (RD)|5.7|||<|0.0001|TWO_SIDED|95.0|-1.4|12.8|||Z test|||||12.8|-1.4|<0.0001
72450366|NCT03926130|144420239|SUPERIORITY||Risk Difference (RD)|6.8||||0.003414|TWO_SIDED|95.0|3.2|10.5|||Cochran-Mantel-Haenszel|||||10.5|3.2|0.003414
72450367|NCT03926130|144420240|SUPERIORITY||LSMean Difference (Net)|-0.86||||1.1e-05|TWO_SIDED|95.0|-1.24|-0.48|||ANCOVA|||||-0.48|-1.24|0.000011
72450368|NCT03926130|144420241|SUPERIORITY||LSMean Difference (Net)|-2.01|||<|1e-06|TWO_SIDED|95.0|-2.42|-1.6|||ANCOVA|||||-1.60|-2.42|<0.000001
72450369|NCT03926130|144420242|SUPERIORITY||Risk Difference (RD)|25.7|||<|1e-06|TWO_SIDED|95.0|18.9|32.6|||Cochran-Mantel-Haenszel|||||32.6|18.9|<0.000001
72450370|NCT03926130|144420243|SUPERIORITY||Risk Difference (RD)|13.8|||<|1e-06|TWO_SIDED|95.0|10.2|17.4|||Cochran-Mantel-Haenszel|||||17.4|10.2|<0.000001
72450371|NCT03926130|144420244|SUPERIORITY||Risk Difference (RD)|25.0|||<|1e-06|TWO_SIDED|95.0|18.2|31.8|||Cochran-Mantel-Haenszel|||||31.8|18.2|<0.000001
72450372|NCT03926130|144420245|SUPERIORITY||LSMean Difference (Net)|-0.85|||<|1e-06|TWO_SIDED|95.0|-1.05|-0.65|||ANCOVA|||||-0.65|-1.05|<0.000001
72450373|NCT03926130|144420246|SUPERIORITY||LSMean Difference (Net)|-1.22|||<|1e-06|TWO_SIDED|95.0|-1.48|-0.95|||ANCOVA|||||-0.95|-1.48|<0.000001
72450374|NCT03926130|144420247|SUPERIORITY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
72450375|NCT03926130|144420248|SUPERIORITY||Risk Difference (RD)|4.1||||0.732715|TWO_SIDED|95.0|-18.0|26.1|||Cochran-Mantel-Haenszel|||||26.1|-18.0|0.732715
72450376|NCT03926130|144420249|SUPERIORITY||LSMean Difference (Net)|27.92|||<|1e-06|TWO_SIDED|95.0|22.67|33.18|||ANCOVA|||||33.18|22.67|<0.000001
72450377|NCT03926130|144420251|SUPERIORITY||Risk Difference (RD)|10.6||||0.000213|TWO_SIDED|99.5|4.1|17.2|||Cochran-Mantel-Haenszel|||||17.2|4.1|0.000213
72450378|NCT03926130|144420252|SUPERIORITY||Risk Difference (RD)|19.4|||<|1e-06|TWO_SIDED|99.5|13.1|25.7|||Cochran-Mantel-Haenszel|||||25.7|13.1|<0.000001
72450379|NCT01730937|144420253|SUPERIORITY||Hazard Ratio (HR)|0.77||||0.0554|TWO_SIDED|90.0|0.59|1.01|||Log Rank||Reference arm = Sorafenib Alone|Original design: Hypothesized 28% reduction (HR=0.72) with SBRT (corresponds to median OS = 14.5 months). Assuming an exponential distribution and constant hazards, 292 patients were required to reach 238 OS events, with 80% statistical power, a 1-sided α of 0.05. Revised design (see limitations/caveats): For same above hypotheses, at least 155 OS events from 193 randomized patients provided 65% statistical power, with a 1-sided α of 0.05.||1.01|0.59|0.0554
72450380|NCT01730937|144420254|SUPERIORITY||Hazard Ratio (HR)|0.69||||0.034|TWO_SIDED|95.0|0.48|0.99||Two-sided significance level = 0.05|Gray's test||Reference arm = Sorafenib Alone|||0.99|0.48|0.034
72450381|NCT01730937|144420255|SUPERIORITY||Hazard Ratio (HR)|0.55||||0.0001|TWO_SIDED|95.0|0.4|0.75||Two-sided significance level=0.05|Log Rank||Reference arm = Sorafenib Alone|||0.75|0.40|0.0001
72450382|NCT03331835|144420368|SUPERIORITY||Risk Difference (RD)|42.86|||<|0.001|TWO_SIDED|95.0|30.93|54.79|||Cochran-Mantel-Haenszel|95% CI and p-value are derived from CMH analysis stratified by weight group at baseline (≤100 kg, \> 100 kg).||Estimated risk difference, 95% CI and p-value are derived from Cochran-Mantel-Haenszel (CMH) analysis stratified by weight group at baseline (≤100 kg, \> 100 kg). Non-responder Imputation (NRI) was used to impute missing data. Treatment groups were defined as randomised treatment.||54.79|30.93|<0.001
72450383|NCT03331835|144420369|SUPERIORITY||Risk Difference (RD)|44.76|||<|0.001|TWO_SIDED|95.0|32.81|56.71|||Cochran-Mantel-Haenszel|95% CI and p-value are derived from CMH analysis stratified by weight group at baseline (≤100 kg, \> 100 kg)||Estimated risk difference, 95% CI and p-value are derived from Cochran-Mantel-Haenszel (CMH) analysis stratified by weight group at baseline (≤100 kg, \> 100 kg). Non-responder Imputation (NRI) was used to impute missing data. Treatment groups were defined as randomised treatment.||56.71|32.81|<0.001
72450384|NCT03331835|144420370|SUPERIORITY||Risk Difference (RD)|43.81|||<|0.001|TWO_SIDED|95.0|31.78|55.84|||Cochran-Mantel-Haenszel|||Estimated risk difference, 95% CI and p-value are derived from Cochran-Mantel-Haenszel (CMH) analysis stratified by weight group at baseline (≤100 kg, \> 100 kg). Non-responder Imputation (NRI) was used to impute missing data. Treatment groups were defined as randomised treatment.||55.84|31.78|<0.001
72450385|NCT03331835|144420371|SUPERIORITY||Risk Difference (RD)|31.43|||<|0.001|TWO_SIDED|95.0|20.76|42.1|||Cochran-Mantel-Haenszel|||Estimated risk difference, 95% CI and p-value are derived from Cochran-Mantel-Haenszel (CMH) analysis stratified by weight group at baseline (≤100 kg, \> 100 kg). Non-responder Imputation (NRI) was used to impute missing data. Treatment groups were defined as randomised treatment.||42.10|20.76|<0.001
72450386|NCT03331835|144420372|SUPERIORITY||Mean Difference (Net)|-3.08|||<|0.001|TWO_SIDED|95.0|-4.83|-1.33|||Mixed Models Analysis|||The endpoint was analysed using mixed model for repeated measures (MMRM) model including treatment group, week, interaction between treatment and time, baseline value, and baseline weight group as fixed factors. Within participant covariance was estimated by an unstructured covariance matrix. Treatment groups were defined as randomised treatment.||-1.33|-4.83|<0.001
72450387|NCT03331835|144420373|SUPERIORITY||Mean Difference (Net)|-16.36|||<|0.001|TWO_SIDED|95.0|-23.03|-9.68|||Mixed Models Analysis|||The endpoint was analysed using mixed model for repeated measures (MMRM) model including treatment group, week, interaction between treatment and time, baseline value, and baseline weight group as fixed factors. Within participant covariance was estimated by an unstructured covariance matrix. Treatment groups were defined as randomised treatment.||-9.68|-23.03|<0.001
72450388|NCT03331835|144420374|SUPERIORITY||Mean Difference (Net)|-8.91|||<|0.001|TWO_SIDED|95.0|-13.0|-4.81|||Mixed Models Analysis|||The endpoint was analysed using mixed model for repeated measures (MMRM) model including treatment group, week, interaction between treatment and time, baseline value, and baseline weight group as fixed factors. Within participant covariance was estimated by an unstructured covariance matrix. Treatment groups were defined as randomised treatment.||-4.81|-13.00|<0.001
72450389|NCT03331835|144420378|SUPERIORITY||Mean Difference (Final Values)|-4.92|||<|0.001|TWO_SIDED|95.0|-6.31|-3.53|||ANCOVA|||The AUC was analysed using analysis of covariance (ANCOVA) with treatment group, baseline weight group, and the baseline PSI total score as explanatory variables. Treatment groups are defined as randomised treatment.||-3.53|-6.31|<0.001
72469955|NCT00559377|144463853|SUPERIORITY_OR_OTHER||Spearman Correlation|0.004|||<|0.05|TWO_SIDED||||||Spearman Correlation|||The correlation between IHC values and FMISO uptake were analyzed using Spearman correlation where p values less than 0.05 were considered significant.||||<0.05
72450390|NCT03331835|144420379|SUPERIORITY||Mean Difference (Net)|-2.57||||0.004|TWO_SIDED|95.0|-4.32|-0.82|||Mixed Models Analysis|||The endpoint is analysed by using mixed model for repeated measurements (MMRM) model including treatment group, week, interaction between treatment and time, baseline value, and baseline weight group as fixed factors. Within participant covariance was estimated by an unstructured covariance matrix. Treatment groups are defined as randomised treatment.||-0.82|-4.32|0.004
72390957|NCT02610725|144289626|SUPERIORITY||Mean Difference (Final Values)|6.06|STANDARD_ERROR_OF_MEAN|0.98|<|0.001|TWO_SIDED|95.0|4.1|8.02|||t-test, 2 sided|51 degrees of freedom|Means were analyzed in a (pre-post) format. A positive mean indicates a decrease in negative affect.|Paired-samples t-tests were used to analyze change in affect after participating in the yoga class. Analyses were conducted to measure changes in both positive affect and negative affect. This entry describes negative affect analysis.||8.02|4.10|<0.001
72390958|NCT00826943|144289629|SUPERIORITY_OR_OTHER|||||||0.03||95.0||||The threshold for significance was p \< 0.05.|Wilcoxon (Mann-Whitney)|||||||.03
72450391|NCT03331835|144420380|SUPERIORITY|Estimated risk difference, 95% CI and p-value are derived from Cochran-Mantel-Haenszel (CMH) analysis stratified by weight group at baseline (\<=100 kg, \> 100 kg). Non-responder Imputation (NRI) was used to impute missing data. Treatment groups were defined as randomised treatment.|Risk Difference (RD)|40.95|||<|0.001|TWO_SIDED|95.0|28.75|53.16|||Cochran-Mantel-Haenszel|||||53.16|28.75|<0.001
72390959|NCT00826943|144289629|SUPERIORITY_OR_OTHER|||||||0.11||||||The threshold for significance was p \< 0.05.|Wilcoxon (Mann-Whitney)|||||||.11
72450392|NCT03331835|144420381|SUPERIORITY|The endpoint was analysed by using mixed model for repeated measures (MMRM) model including treatment group, week, interaction between treatment and time, baseline value, and baseline weight group as fixed factors. Within participant covariance was estimated by an unstructured covariance matrix. Treatment groups were defined as randomised treatment.|Mean Difference (Net)|-1.72||||0.028|TWO_SIDED|95.0|-3.24|-0.19|||Mixed Models Analysis|||||-0.19|-3.24|0.028
72450393|NCT06037668|144420454|SUPERIORITY|||||||0.1134||||||p-values are calculated by independent t-test|Independent t-test|||||||0.1134
72450394|NCT06037668|144420455|SUPERIORITY|||||||0.0031||||||p-values are calculated by independent t-test|Independent t-test|||||||0.003100
72450395|NCT06037668|144420456|SUPERIORITY|||||||0.0503||||||p-values are calculated by independent t-test|Independent t-test|||||||0.050300
72450396|NCT06037668|144420457|SUPERIORITY|||||||0.1178||||||p-values are calculated by independent t-test|Independent t-test|||||||0.1178
72450397|NCT06037668|144420458|SUPERIORITY|||||||0.1003||||||p-values are calculated by independent t-test|Independent t-test|||||||0.1003
72450398|NCT06037668|144420459|SUPERIORITY|||||||0.4832||||||p-values are calculated by independent t-test|Independent t-test|||||||0.4832
72450399|NCT04479761|144420535|OTHER|T test derived from a linear mixed effects model|Mean Difference (Final Values)|0.52||||0.005|TWO_SIDED|95.0|||||Mixed Models Analysis||we provided the mean difference between the vestibular group and healthy controls for the reported condition.|||||0.005
72450400|NCT04479761|144420536|OTHER|T tests derived from linear mixed effects model|Mean Difference (Final Values)|0.23||||0.008|TWO_SIDED||||||Mixed Models Analysis||we provided the mean difference between the vestibular group and the controls on the reported condition.|||||0.008
72450401|NCT04011644|144420537|SUPERIORITY|||||||0.688|||||||Mixed Models Analysis|Quanbeck,A.et al. A randomized trial testing digital medicine support models for mild-to-moderate alcohol use disorder. npj Digit. Med.7,248(2024)||||||0.688
72450402|NCT04011644|144420538|SUPERIORITY|||||||0.261|||||||Mixed Models Analysis|||||||0.261
72450403|NCT04011644|144420539|SUPERIORITY|||||||0.014|||||||Mixed Models Analysis|||||||0.014
72450404|NCT04011644|144420541|SUPERIORITY|||||||0.908|||||||ANCOVA|||A univariate analysis (Analysis of Covariance or ANCOVA) was conducted to compare the number of hospital days among the three groups controlling for baseline assessment of the dependent variable and design factors (i.e., Sex and Severity).||||0.908
72450405|NCT04011644|144420543|SUPERIORITY|||||||0.206|||||||ANCOVA|||A univariate analysis (Analysis of Covariance or ANCOVA) was conducted to compare the number of hospital days among the three groups controlling for baseline assessment of the dependent variable and design factors (i.e., Sex and Severity).||||0.206
72450406|NCT04011644|144420544|SUPERIORITY|||||||0.104|||||||ANCOVA|||A univariate analysis (Analysis of Covariance or ANCOVA) was conducted to compare the number of hospital days among the three groups controlling for baseline assessment of the dependent variable and design factors (i.e., Sex and Severity).||||0.104
72450407|NCT04011644|144420545|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
72390960|NCT00826943|144289629|SUPERIORITY_OR_OTHER|||||||0.45|||||||Wilcoxon (Mann-Whitney)|||||||.45
72390961|NCT00826943|144289630|SUPERIORITY_OR_OTHER|||||||0.27||95.0||||The threshold for significance was p \< .05.|Wilcoxon (Mann-Whitney)|||||||.27
72390962|NCT00826943|144289630|SUPERIORITY_OR_OTHER|||||||0.8||||||The threshold for significance was p \< 0.05.|Wilcoxon (Mann-Whitney)|||||||.8
72390963|NCT00826943|144289630|SUPERIORITY_OR_OTHER|||||||0.52||||||The threshold for significance was p \< 0.05.|Wilcoxon (Mann-Whitney)|||||||.52
72390964|NCT00826943|144289631|SUPERIORITY_OR_OTHER|||||||0.14||95.0||||The threshold for significance was p \< 0.05.|Wilcoxon (Mann-Whitney)|||||||.14
72390965|NCT00826943|144289631|SUPERIORITY_OR_OTHER|||||||0.54|||||||Wilcoxon (Mann-Whitney)|||||||.54
72390966|NCT00826943|144289631|SUPERIORITY_OR_OTHER|||||||0.42|||||||Wilcoxon (Mann-Whitney)|||||||.42
72390967|NCT01703039|144289658|SUPERIORITY|||||||0.06|||||||ANOVA|||||||0.06
72390968|NCT01703039|144289659|SUPERIORITY|||||||0.31|||||||Chi-squared|||||||0.31
72390969|NCT01703039|144289660|SUPERIORITY|||||||0.34|||||||Chi-squared|||||||0.34
72390970|NCT01703039|144289661|SUPERIORITY|||||||0.27|||||||ANOVA|||||||0.27
72390971|NCT01703039|144289662|SUPERIORITY|||||||0.04|||||||ANOVA|||||||0.04
72390972|NCT02302807|144289680|SUPERIORITY||Hazard Ratio (HR)|0.87||||0.4134|TWO_SIDED|95.0|0.63|1.21|||Log Rank|||||1.21|0.63|0.4134
72390973|NCT02302807|144289680|SUPERIORITY||Hazard Ratio (HR)|0.87|||||TWO_SIDED|95.0|0.71|1.05||||||||1.05|0.71|
72450408|NCT04011644|144420546|SUPERIORITY|||||||0.025|||||||Mixed Models Analysis|||||||0.025
72450409|NCT04011644|144420547|SUPERIORITY|||||||0.555|||||||Mixed Models Analysis|||||||0.555
72450410|NCT04011644|144420548|SUPERIORITY|||||||0.131|||||||Kruskal-Wallis|||||||0.131
72450411|NCT04011644|144420552|SUPERIORITY|||||||0.02|||||||Kruskal-Wallis|||||||0.02
72390974|NCT02302807|144289680|SUPERIORITY||Hazard Ratio (HR)|0.85|||||TWO_SIDED|95.0|0.73|0.99||||||||0.99|0.73|
72390975|NCT04518306|144289698|SUPERIORITY||LS Means Difference|-7.33|STANDARD_ERROR_OF_MEAN|1.451|<|0.0001|TWO_SIDED|95.0|-10.176|-4.486||No adjustment for multiplicity was made and the 0.05 level of significance was used to claim efficacy compared with placebo|MIANALYZE procedure|||The analysis was performed using a mixed model for repeated measures (MMRM) for estimating the difference between Triple ¼ GMRx2 and placebo at Week 4||-4.486|-10.176|<0.0001
72390976|NCT04518306|144289698|SUPERIORITY||LS Means Difference|-8.23|STANDARD_ERROR_OF_MEAN|1.57|<|0.0001|TWO_SIDED|95.0|-11.305|-5.151||No adjustment for multiplicity was made and the 0.05 level of significance was used to claim efficacy compared with placebo|MIANALYZE procedure|||The analysis was performed using a mixed model for repeated measures (MMRM) for estimating the difference between Triple ½ GMRx2 and placebo at Week 4||-5.151|-11.305|<0.0001
72390977|NCT04518306|144289699|SUPERIORITY||LS Means Difference|-7.98|STANDARD_ERROR_OF_MEAN|1.649|<|0.0001|TWO_SIDED|95.0|-11.281|-4.681||No adjustment for multiplicity was made and the 0.05 level of significance was used to claim efficacy compared with placebo|MMRM procedure|||||-4.681|-11.281|<0.0001
72390978|NCT04518306|144289699|SUPERIORITY||LS Means Difference|-9.52|STANDARD_ERROR_OF_MEAN|2.034|<|0.0001|TWO_SIDED|95.0|-13.588|5.449||No adjustment for multiplicity was made and the 0.05 level of significance was used to claim efficacy compared with placebo|MMRM procedure|||||5.449|-13.588|<0.0001
72390979|NCT04518306|144289700|SUPERIORITY||LS Means Difference|-4.0|STANDARD_ERROR_OF_MEAN|1.204||0.0015|TWO_SIDED|95.0|-6.413|-1.597||No adjustment for multiplicity was made and the 0.05 level of significance was used to claim efficacy compared with placebo|MMRM procedure|||||-1.597|-6.413|0.0015
72390980|NCT04518306|144289700|SUPERIORITY||LS Means Difference|-4.86|STANDARD_ERROR_OF_MEAN|1.133|<|0.0001|TWO_SIDED|95.0|-7.13|-2.595||No adjustment for multiplicity was made and the 0.05 level of significance was used to claim efficacy compared with placebo|MMRM procedure|||||-2.595|-7.130|<0.0001
72390981|NCT04518306|144289701|SUPERIORITY||Risk Difference (RD)|28.09||||0.0002|TWO_SIDED|95.0|11.811|42.45|||Wald test||95% confidence intervals for risk difference utilized Newcombe estimation method|||42.450|11.811|0.0002
72390982|NCT04518306|144289701|SUPERIORITY||Risk Difference (RD)|33.24|||<|0.0001|TWO_SIDED|95.0|17.199|47.186|||Wald test||95% confidence intervals for risk difference utilize Newcombe estimation method|||47.186|17.199|<0.0001
72390983|NCT04518306|144289702|SUPERIORITY||Risk Difference (RD)|17.18|||<|0.0001|TWO_SIDED|95.0|6.07|26.385||No adjustment for multiplicity was made and the 0.05 level of significance was used to claim efficacy compared with placebo.|Wald test||95% confidence intervals for risk difference utilized Newcombe estimation method.|Percentages were calculated from the total number of participants within the randomized set.||26.385|6.070|<0.0001
72390984|NCT04518306|144289702|SUPERIORITY||Risk Difference (RD)|27.08|||<|0.0001|TWO_SIDED|95.0|15.237|36.646||No adjustment for multiplicity was made and the 0.05 level of significance was used to claim efficacy compared with placebo|Wald test||95% confidence intervals for risk difference utilized Newcombe estimation method|Percentages were calculated from the total number of participants within the randomized set||36.646|15.237|<0.0001
72390985|NCT04518306|144289703|SUPERIORITY||LS Means Difference|-4.0|STANDARD_ERROR_OF_MEAN|0.991||0.0002|TWO_SIDED|95.0|-5.978|-2.013||No adjustment for multiplicity was made and the 0.05 level of significance was used to claim efficacy compared with placebo|MMRM procedure|||||-2.013|-5.978|0.0002
72390986|NCT04518306|144289703|SUPERIORITY||LS Means Difference|-5.51|STANDARD_ERROR_OF_MEAN|0.908|<|0.0001|TWO_SIDED|95.0|-7.328|-3.694||No adjustment for multiplicity was made and the 0.05 level of significance was used to claim efficacy compared with placebo|MMRM procedure|||||-3.694|-7.328|<0.0001
72390987|NCT04518306|144289704|SUPERIORITY||LS Means Difference|-6.79|STANDARD_ERROR_OF_MEAN|1.752||0.0003|TWO_SIDED|95.0|-10.3|-3.287||No adjustment for multiplicity was made and the 0.05 level of significance was used to claim efficacy compared with placebo|MMRM procedure|||The difference between Triple ¼ GMRx2 Dose and placebo at Week 4 was estimated using MMRM||-3.287|-10.300|0.0003
72390988|NCT04518306|144289704|SUPERIORITY||LS Means Difference|-8.74|STANDARD_ERROR_OF_MEAN|1.829|<|0.0001|TWO_SIDED|95.0|-12.403|-5.082||No adjustment for multiplicity was made and the 0.05 level of significance was used to claim efficacy compared with placebo|MMRM procedure|||The difference between Triple ½ GMRx2 Dose and placebo at Week 4 was estimated using MMRM||-5.082|-12.403|<0.0001
72390989|NCT04518306|144289705|SUPERIORITY||LS Means Difference|-3.86|STANDARD_ERROR_OF_MEAN|1.004||0.0003|TWO_SIDED|95.0|-5.865|-1.847||No adjustment for multiplicity was made and the 0.05 level of significance was used to claim efficacy compared with placebo|MMRM procedure|||The difference between Triple ¼ GMRx2 Dose and placebo at Week 4 was estimated using MMRM||-1.847|-5.865|0.0003
72390990|NCT04518306|144289705|SUPERIORITY||LS Means Difference|-5.42|STANDARD_ERROR_OF_MEAN|1.245|<|0.0001|TWO_SIDED|95.0|-7.915|-2.932||No adjustment for multiplicity was made and the 0.05 level of significance was used to claim efficacy compared with placebo|MMRM procedure|||The difference between Triple ½ GMRx2 Dose and placebo at Week 4 was estimated using MMRM||-2.932|-7.915|<0.0001
72390991|NCT04518306|144289706|SUPERIORITY||Risk Difference (RD)|35.48|||<|0.0001|TWO_SIDED|95.0|19.541|48.549||No adjustment for multiplicity was made and the 0.05 level of significance was used to claim efficacy compared with placebo|Wald test||95% confidence intervals for risk difference utilized Newcombe estimation method|||48.549|19.541|<0.0001
72390992|NCT04518306|144289706|SUPERIORITY||Risk Difference (RD)|29.97|||<|0.0001|TWO_SIDED|95.0|14.218|43.093||No adjustment for multiplicity was made and the 0.05 level of significance was used to claim efficacy compared with placebo|Wald test||95% confidence intervals for risk difference utilized Newcombe estimation method|||43.093|14.218|<0.0001
72390993|NCT04518306|144289707|SUPERIORITY||Risk Difference (RD)|17.21||||0.003|TWO_SIDED|95.0|3.637|28.424||No adjustment for multiplicity was made and the 0.05 level of significance was used to claim efficacy compared with placebo|Wald test||95% confidence intervals for risk difference utilized Newcombe estimation method|||28.424|3.637|0.0030
72390994|NCT04518306|144289707|SUPERIORITY||Risk Difference (RD)|22.5|||<|0.0001|TWO_SIDED|95.0|8.72|33.665||No adjustment for multiplicity was made and the 0.05 level of significance was used to claim efficacy compared with placebo|Wald test||95% confidence intervals for risk difference utilized Newcombe estimation method|||33.665|8.720|<0.0001
72390995|NCT04518306|144289708|SUPERIORITY||Risk Difference (RD)|-1.61|||||TWO_SIDED|95.0|-9.83|2.76|||||95% confidence intervals for risk difference utilized Newcombe estimation method|||2.760|-9.830|
72619607|NCT02070380|144770027|SUPERIORITY_OR_OTHER|||||||1|||||||Wilcoxon signed-rank test|||"Null hypotheses:~A 0.05 mmol/kg dose of MULTIHANCE is equal to a 0.1 mmol/kg dose of DOTAREM, in terms of the assessment of Lesion Contrast Enhancement in an off-site pre-dose plus post-dose paired global assessment."||||1.0000
72619608|NCT02070380|144770027|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon signed-rank test|||"Null hypotheses:~A 0.1 mmol/kg dose of MULTIHANCE is equal to a 0.1 mmol/kg dose of DOTAREM, in terms of the assessment of Lesion Contrast Enhancement in an off-site pre-dose plus postdose paired global assessment."||||<0.0001
72619609|NCT02070380|144770027|SUPERIORITY_OR_OTHER|||||||0.7503|||||||Wilcoxon signed-rank test|||"Null hypotheses:~A 0.05 mmol/kg dose of MULTIHANCE is equal to a 0.1 mmol/kg dose of DOTAREM, in terms of the assessment of Lesion Contrast Enhancement in an off-site pre-dose plus postdose paired global assessment."||||0.7503
72619610|NCT02070380|144770027|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon signed-rank test|||"Null hypotheses:~A 0.1 mmol/kg dose of MULTIHANCE is equal to a 0.1 mmol/kg dose of DOTAREM, in terms of the assessment of Lesion Contrast Enhancement in an off-site pre-dose plus postdose paired global assessment."||||<0.0001
72619611|NCT02070380|144770027|SUPERIORITY_OR_OTHER|||||||0.5983|||||||Wilcoxon signed-rank test|||"Null hypotheses:~A 0.05 mmol/kg dose of MULTIHANCE is equal to a 0.05 mmol/kg dose of DOTAREM, in terms of the assessment of Lesion Contrast Enhancement in an off-site pre-dose plus postdose paired global assessment."||||0.5983
72619612|NCT02070380|144770028|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|Mixed effect model with period, sequence, and IP and fixed effect and subject nested within sequence as random effect||||||<0.0001
72619613|NCT02070380|144770028|SUPERIORITY_OR_OTHER|||||||0.6898|||||||Mixed Models Analysis|Mixed effect model with period, sequence, and IP and fixed effect and subject nested within sequence as random effect||||||0.6898
72619614|NCT02070380|144770028|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|Mixed effect model with period, sequence, and IP and fixed effect and subject nested within sequence as random effect.||||||<0.0001
72619615|NCT02070380|144770028|SUPERIORITY_OR_OTHER|||||||0.1156|||||||Mixed Models Analysis|Mixed effect model with period, sequence, and IP and fixed effect and subject nested within sequence as random effect||||||0.1156
72619616|NCT02070380|144770028|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||<0.0001
72390996|NCT04518306|144289708|SUPERIORITY||Risk Difference (RD)|3.47|||||TWO_SIDED|95.0|-5.276|9.774|||||95% confidence intervals for risk difference utilized Newcombe estimation method|||9.774|-5.276|
72450412|NCT02997202|144420554|SUPERIORITY||Hazard Ratio (HR)|0.679||||0.0518|TWO_SIDED|95.0|0.459|1.005|||Log Rank|||Stratification factors were conditioning regimen intensity MAC vs RIC/NMA, time from transplant to randomization (30 to 60 days vs 61 to 90 days), and the presence of MRD (present vs absent/unknown) based on the pre-transplant BM aspirate.||1.005|0.459|0.0518
72619617|NCT02070380|144770028|SUPERIORITY_OR_OTHER|||||||0.7726|||||||Mixed Models Analysis|||||||0.7726
72619618|NCT02070380|144770029|SUPERIORITY_OR_OTHER|||||||0.0002|||||||Mixed Models Analysis|Investigation product (IP) effect from mixed model with period, sequence, and IP as fixed effects and subject nested within sequence as random effect.||||||0.0002
72450413|NCT02997202|144420555|SUPERIORITY||Hazard Ratio (HR)|0.846||||0.4394|TWO_SIDED|95.0|0.554|1.293|||Log Rank|||Stratification factors were conditioning regimen intensity MAC vs RIC/NMA, time from transplant to randomization (30 to 60 days vs 61 to 90 days), and the presence of MRD (present vs absent/unknown) based on the pre-transplant BM aspirate.||1.293|0.554|0.4394
72619619|NCT02070380|144770029|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|Investigation product (IP) effect from mixed model with period, sequence, and IP as fixed effects and subject nested within sequence as random effect.||||||<0.0001
72619620|NCT02070380|144770029|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|Investigation product (IP) effect from mixed model with period, sequence, and IP as fixed effects and subject nested within sequence as random effect.||||||<0.0001
72619621|NCT02070380|144770029|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|Investigation product (IP) effect from mixed model with period, sequence, and IP as fixed effects and subject nested within sequence as random effect.||||||<0.0001
72390997|NCT04518306|144289709|SUPERIORITY||Risk Difference (RD)|-3.23|||||TWO_SIDED|95.0|-12.171|1.662|||||95% confidence intervals for risk difference utilized Newcombe estimation method|||1.662|-12.171|
72390998|NCT04518306|144289709|SUPERIORITY||Risk Difference (RD)|-1.53|||||TWO_SIDED|95.0|-10.585|4.049||||||||4.049|-10.585|
72390999|NCT04518306|144289710|SUPERIORITY||Risk Difference (RD)|3.54|||||TWO_SIDED|95.0|-4.115|9.352|||||95% confidence intervals for risk difference utilize Newcombe estimation method|||9.352|-4.115|
72391000|NCT04518306|144289710|SUPERIORITY||Risk Difference (RD)|5.08|||||TWO_SIDED|95.0|-2.779|11.2||||||||11.200|-2.779|
72619622|NCT02070380|144770029|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|Investigation product (IP) effect from mixed model with period, sequence, and IP as fixed effects and subject nested within sequence as random effect.||||||<0.0001
72619623|NCT02070380|144770029|SUPERIORITY_OR_OTHER|||||||0.0003|||||||Mixed Models Analysis|Investigation product (IP) effect from mixed model with period, sequence, and IP as fixed effects and subject nested within sequence as random effect.||||||0.0003
72619624|NCT03850431|144770030|OTHER||Odds Ratio (OR)|1.139||||0.145|TWO_SIDED|95.0|0.956|1.357|||Regression, Logistic|Logistic regression with clustering for clinics and patients||||1.357|0.956|0.145
72619625|NCT03850431|144770030|OTHER||Odds Ratio (OR)|1.11||||0.298|TWO_SIDED|95.0|0.912|1.35|||Regression, Logistic|Logistic regression with clustering for clinics and patients||||1.35|0.912|0.298
72619626|NCT03850431|144770030|OTHER||Odds Ratio (OR)|1.178||||0.127|TWO_SIDED|95.0|0.955|1.452|||Regression, Logistic|Logistic regression with clustering for clinics and patients||||1.452|0.955|0.127
72619627|NCT03850431|144770030|OTHER||Odds Ratio (OR)|1.117||||0.286|TWO_SIDED|95.0|0.911|1.37|||Regression, Logistic|Logistic regression with clustering for clinics and patients||||1.37|0.911|0.286
72619628|NCT03850431|144770030|OTHER||Odds Ratio (OR)|1.179||||0.183|TWO_SIDED|95.0|0.925|1.504|||Regression, Logistic|Logistic regression with clustering for clinics and patients||||1.504|0.925|0.183
72619629|NCT03850431|144770030|OTHER||Odds Ratio (OR)|1.2||||0.209|TWO_SIDED|95.0|0.903|1.595|||Regression, Logistic|Logistic regression with clustering for clinics and patients||||1.595|0.903|0.209
72619630|NCT03850431|144770030|OTHER||Odds Ratio (OR)|1.144||||0.463|TWO_SIDED|95.0|0.799|1.638|||Regression, Logistic|Logistic regression with clustering for clinics and patients||||1.638|0.799|0.463
72450414|NCT02997202|144420558|SUPERIORITY||Hazard Ratio (HR)|2.308||||0.0209|TWO_SIDED|95.0|1.1352|4.6922|||Fine-Grays Model|||Based on Fine \& Gray's model adjusting for conditioning regimen intensity (MAC vs RIC/NMA), time from transplant to randomization (30-60 days vs 61-90 days) \& presence of MRD (present vs absent/indeterminate) based on the pre-transplant BM aspirate.||4.6922|1.1352|0.0209
72450415|NCT02997202|144420559|SUPERIORITY||Hazard Ratio (HR)|0.93||||0.6417|TWO_SIDED|95.0|0.686|1.261|||Log Rank|||Stratification factors were conditioning regimen intensity MAC vs RIC/NMA, time from transplant to randomization (30 to 60 days vs 61 to 90 days), and the presence of MRD (present vs absent/unknown) based on the pre-transplant BM aspirate.||1.261|0.686|0.6417
72450416|NCT02997202|144420560|SUPERIORITY||Hazard Ratio (HR)|0.8938||||0.641|TWO_SIDED|95.0|0.5574|1.433|||Fine-Grays model|||"aGVHD II to IV:~Based on Fine and Gray's model adjusting for conditioning regimen intensity (MAC vs RIC/NMA), time from transplant to randomization (30-60 days vs 61-90 days) \& presence of MRD (present vs absent/indeterminate) based on the pre-transplant BM aspirate."||1.4330|0.5574|0.6410
72450417|NCT02997202|144420560|SUPERIORITY||Hazard Ratio (HR)|1.4254||||0.4128|TWO_SIDED|95.0|0.6103|3.3289|||Fine-Grays model|||"aGVHD III to IV:~Based on Fine and Gray's model adjusting for conditioning regimen intensity (MAC vs RIC/NMA), time from transplant to randomization (30-60 days vs 61-90 days) \& presence of MRD (present vs absent/indeterminate) based on the pre-transplant BM aspirate."||3.3289|0.6103|0.4128
72450418|NCT02997202|144420561|SUPERIORITY||Hazard Ratio (HR)|1.236||||0.1725|TWO_SIDED|95.0|0.9116|1.6757|||Fine-Grays Model|||Based on Fine and Gray's model adjusting for conditioning regimen intensity (MAC vs RIC/NMA), time from transplant to randomization (30-60 days vs 61-90 days) \& presence of MRD (present vs absent/indeterminate) based on the pre-transplant BM aspirate.||1.6757|0.9116|0.1725
72450419|NCT02997202|144420562|SUPERIORITY||Hazard Ratio (HR)|1.236||||0.1725|TWO_SIDED|95.0|0.9116|1.6757|||Fine-Grays Model|||Based on Fine and Gray's model adjusting for conditioning regimen intensity (MAC vs RIC/NMA), time from transplant to randomization (30-60 days vs 61-90 days) \& presence of MRD (present vs absent/indeterminate) based on the pre-transplant BM aspirate.||1.6757|0.9116|0.1725
72450420|NCT02997202|144420563|SUPERIORITY||Hazard Ratio (HR)|3.4537||||0.2029|TWO_SIDED|95.0|0.5126|23.2687|||Fine-Grays Model|||MRD Eradication||23.2687|0.5126|0.2029
72450421|NCT02997202|144420563|SUPERIORITY||Hazard Ratio (HR)|0.7073||||0.4077|TWO_SIDED|95.0|0.3116|1.6055|||Fine-Grays Model|||MRD 10\^-4 Detection||1.6055|0.3116|0.4077
72450422|NCT02997202|144420564|SUPERIORITY||Hazard Ratio (HR)|0.3729|||<|0.001|TWO_SIDED|95.0|0.2243|0.6199|||Fine-Grays Model|||Based on Fine and Gray's model adjusting for conditioning regimen intensity (MAC vs RIC/NMA), time from transplant to randomization (30-60 days vs 61-90 days) \& presence of MRD (present vs absent/indeterminate) based on the pre-transplant BM aspirate.||0.6199|0.2243|<0.001
72450423|NCT02997202|144420565|SUPERIORITY||Hazard Ratio (HR)|1.4848||||0.0568|TWO_SIDED|95.0|0.9886|2.23|||Fine-Grays model|||Based on Fine and Gray's model adjusting for conditioning regimen intensity (MAC vs RIC/NMA), time from transplant to randomization (30-60 days vs 61-90 days) \& presence of MRD (present vs absent/indeterminate) based on the pre-transplant BM aspirate.||2.2300|0.9886|0.0568
72450424|NCT05265065|144420570|NON_INFERIORITY|"Non-inferiority margin of -10% (absolute difference) and a one-sided significance level of 5%.~The sample size calculation assumed an estimated seroresponse rate of 95% in both half- and full-dose arms, a non- inferiority margin of -10% (absolute difference), a one-sided significance level of5%, and no loss to follow- up. Under this scenario, a sample size of 100 per arm provides 90% power to compare seroresponse rates between arms under the non-inferiority framework."|Risk Difference (RD)|-2.9|||||TWO_SIDED|95.0|-7.7|2.0|||Regression, Logistic||The difference in seroresponse was adjusted for age group, priming vaccine, duration between first and second dose, duration between second and third (study) dose, study day of blood draw, and baseline anti-spike IgG (IgG).|Non-inferiority margin of -10% (absolute difference) and a one-sided significance level of 5%.||2.0|-7.7|
72450425|NCT05265065|144420572|NON_INFERIORITY|Non-inferiority margin of -10% (absolute difference)|Risk Difference (RD)|-2.4|||||TWO_SIDED|95.0|-16.1|11.3|||Regression, Logistic||The difference in seroresponse was adjusted for age group, priming vaccine, duration between first and second dose, duration between second and third (study) dose, study day of blood draw, and baseline anti-spike IgG (IgG).|||11.3|-16.1|
72450426|NCT05265065|144420572|NON_INFERIORITY|Non-inferiority margin of -10% (absolute difference)|Risk Difference (RD)|-3.1|||||TWO_SIDED|95.0|-9.5|3.2|||Regression, Logistic||The difference in seroresponse was adjusted for age group, priming vaccine, duration between first and second dose, duration between second and third (study) dose, study day of blood draw, and baseline anti-spike IgG (IgG).|||3.2|-9.5|
72619631|NCT03850431|144770030|OTHER||Odds Ratio (OR)|1.331||||0.074|TWO_SIDED|95.0|0.972|1.822|||Regression, Logistic|Logistic regression with clustering for clinics and patients||||1.822|0.972|0.074
72619632|NCT03850431|144770030|OTHER||Odds Ratio (OR)|1.169||||0.306|TWO_SIDED|95.0|0.867|1.577|||Regression, Logistic|Logistic regression with clustering for clinics and patients||||1.577|0.867|0.306
72450427|NCT05265065|144420572|NON_INFERIORITY|Non-inferiority margin of -10% (absolute difference)|Risk Difference (RD)|-0.5|||||TWO_SIDED|95.0|-17.1|16.1|||Regression, Logistic||The difference in seroresponse was adjusted for age group, priming vaccine, duration between first and second dose, duration between second and third (study) dose, study day of blood draw, and baseline anti-spike IgG (IgG).|||16.1|-17.1|
72450428|NCT05265065|144420573|SUPERIORITY||Geometric Mean Ratio|0.94||||0.228|TWO_SIDED|95.0|0.86|1.04|||Regression, Linear||Adjusted for age group, priming vaccine, duration between 1st and 2nd dose, duration between 2nd and 3rd (study) dose, study day of blood draw, and baseline anti-spike IgG (IgG).|||1.04|0.86|0.228
72450429|NCT05265065|144420574|SUPERIORITY||Geometric Mean Ratio|0.94||||0.537|TWO_SIDED|95.0|0.77|1.15|||Regression, Linear||Adjusted for age group, priming vaccine, duration between 1st and 2nd dose, duration between 2nd and 3rd (study) dose, study day of blood draw, and baseline anti-spike IgG (IgG).|||1.15|0.77|0.537
72469956|NCT00940875|144463861|SUPERIORITY_OR_OTHER||Difference in Response Rates|-3.3|||||TWO_SIDED|95.0|-17.5|10.9|||||The 95% CI for the difference of 2 rates was estimated using the Hauck-Anderson method.|||10.9|-17.5|
72619633|NCT03850431|144770030|OTHER||Odds Ratio (OR)|1.15||||0.373|TWO_SIDED|95.0|0.845|1.565|||Regression, Logistic|Logistic regression with clustering for clinics and patients||||1.565|0.845|0.373
72619634|NCT03850431|144770031|OTHER||Odds Ratio (OR)|0.923||||0.153|TWO_SIDED|95.0|0.826|1.03|||Regression, Logistic|Logistic regression with clustering for clinics and patients||||1.03|0.826|0.153
72391001|NCT04518306|144289711|SUPERIORITY||Risk Difference (RD)|3.54|||||TWO_SIDED|95.0|-4.012|9.35|||||95% confidence intervals for risk difference utilized Newcombe estimation method|||9.350|-4.012|
72450430|NCT05265065|144420574|SUPERIORITY||Geometric Mean Ratio|0.99||||0.922|TWO_SIDED|95.0|0.89|1.11|||Regression, Linear||Adjusted for age group, priming vaccine, duration between 1st and 2nd dose, duration between 2nd and 3rd (study) dose, study day of blood draw, and baseline anti-spike IgG (IgG).|||1.11|0.89|0.922
72391002|NCT04518306|144289711|SUPERIORITY||Risk Difference (RD)|0.84|||||TWO_SIDED|95.0|-6.364|5.278|||||95% confidence intervals for risk difference utilized Newcombe estimation method|||5.278|-6.364|
72391003|NCT04518306|144289712|SUPERIORITY||Risk Difference (RD)|-1.22|||||TWO_SIDED|95.0|-10.928|5.573|||||95% confidence intervals for risk difference utilize Newcombe estimation method|||5.573|-10.928|
72391004|NCT04518306|144289712|SUPERIORITY||Risk Difference (RD)|4.27|||||TWO_SIDED|95.0|1.38|9.53|||||95% confidence intervals for risk difference utilize Newcombe estimation method|||9.53|1.38|
72391005|NCT04518306|144289713|SUPERIORITY||Risk Difference (RD)|1.95|||||TWO_SIDED|95.0|-6.492|7.954|||||95% confidence intervals for risk difference utilized Newcombe estimation method|||7.954|-6.492|
72450431|NCT05265065|144420574|SUPERIORITY||Geometric Mean Ratio|0.71||||0.014|TWO_SIDED|95.0|0.54|0.93|||Regression, Linear||Adjusted for age group, priming vaccine, duration between 1st and 2nd dose, duration between 2nd and 3rd (study) dose, study day of blood draw, and baseline anti-spike IgG (IgG).|||0.93|0.54|0.014
72450432|NCT00303459|144420594|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.831||||0.2508|TWO_SIDED|97.31|0.582|1.187|||Log Rank|||||1.187|0.582|0.2508
72619635|NCT03850431|144770031|OTHER||Odds Ratio (OR)|0.911||||0.252|TWO_SIDED|95.0|0.777|1.068|||Regression, Logistic|Logistic regression with clustering for clinics and patients||||1.068|0.777|0.252
72619636|NCT03850431|144770031|OTHER||Odds Ratio (OR)|0.941||||0.413|TWO_SIDED|95.0|0.815|1.088|||Regression, Logistic|Logistic regression with clustering for clinics and patients||||1.088|0.815|0.413
72619637|NCT03850431|144770031|OTHER||Odds Ratio (OR)|0.946||||0.41|TWO_SIDED|95.0|0.83|1.079|||Regression, Logistic|Logistic regression with clustering for clinics and patients||||1.079|0.83|0.41
72619638|NCT03850431|144770031|OTHER||Odds Ratio (OR)|0.887||||0.11|TWO_SIDED|95.0|0.766|1.027|||Regression, Logistic|Logistic regression with clustering for clinics and patients||||1.027|0.766|0.11
72450433|NCT00303459|144420595|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.963||||0.8385|TWO_SIDED|95.0|0.673|1.38|||Log Rank|||||1.380|0.673|0.8385
72450434|NCT00303459|144420596|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|21.8||||0.0106|TWO_SIDED|95.0|5.9|37.8|||Wilcoxon (Mann-Whitney)|||||37.8|5.9|0.0106
72450435|NCT00303459|144420597|SUPERIORITY_OR_OTHER_LEGACY||Relative risk of improvement|0.98||||1|TWO_SIDED|95.0|0.6|1.61|||Fisher Exact|||||1.61|0.60|1.0000
72450436|NCT00303459|144420598|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.855||||0.4974|TWO_SIDED|95.0|0.544|1.344|||Log Rank|||||1.344|0.544|0.4974
72450437|NCT00303459|144420599|SUPERIORITY_OR_OTHER_LEGACY||Percentage change over placebo|-23.52||||0.0003|TWO_SIDED|95.0|-33.69|-11.79|||Repeated measures analysis|||||-11.79|-33.69|0.0003
72619639|NCT03850431|144770031|OTHER||Odds Ratio (OR)|0.833||||0.14|TWO_SIDED|95.0|0.654|1.062|||Regression, Logistic|Logistic regression with clustering for clinics and patients||||1.062|0.654|0.14
72619640|NCT03850431|144770031|OTHER||Odds Ratio (OR)|0.882||||0.404|TWO_SIDED|95.0|0.657|1.184|||Regression, Logistic|Logistic regression with clustering for clinics and patients||||1.184|0.657|0.404
72619641|NCT03850431|144770031|OTHER||Odds Ratio (OR)|0.743||||0.072|TWO_SIDED|95.0|0.538|1.027|||Regression, Logistic|Logistic regression with clustering for clinics and patients||||1.027|0.538|0.072
72619642|NCT03850431|144770031|OTHER||Odds Ratio (OR)|0.778||||0.057|TWO_SIDED|95.0|0.6|1.008|||Regression, Logistic|Logistic regression with clustering for clinics and patients||||1.008|0.6|0.057
72619643|NCT03850431|144770031|OTHER||Odds Ratio (OR)|0.932||||0.637|TWO_SIDED|95.0|0.697|1.247|||Regression, Logistic|Logistic regression with clustering for clinics and patients||||1.247|0.697|0.637
72391006|NCT04518306|144289713|SUPERIORITY||Risk Difference (RD)|3.45|||||TWO_SIDED|95.0|-5.171|9.704|||||95% confidence intervals for risk difference utilized Newcombe estimation method|||9.704|-5.171|
72391007|NCT04518306|144289714|SUPERIORITY||Risk Difference (RD)|0.88|||||TWO_SIDED|95.0|-6.324|5.548|||||95% confidence intervals for risk difference utilized Newcombe estimation method|||5.548|-6.324|
72391008|NCT04518306|144289714|SUPERIORITY||number of participants at 95% CI|0.0|||||TWO_SIDED|95.0|0.0|3.05|||||For this particular parameter we have used number of participants at 95% CI computed from Clopper-Pearson method as no risk difference was found between the Triple ½ (GMRx2) vs placebo|||3.05|0.00|
72391009|NCT04518306|144289715|SUPERIORITY||Risk Difference (RD)|-1.59|||||TWO_SIDED|95.0|-9.684|2.778|||||95% confidence intervals for risk difference utilized Newcombe estimation method|||2.778|-9.684|
72391010|NCT04518306|144289715|SUPERIORITY||Risk Difference (RD)|-1.59|||||TWO_SIDED|95.0|-9.684|2.59|||||95% confidence intervals for risk difference utilized Newcombe estimation method.|||2.590|-9.684|
72391011|NCT04518306|144289716|SUPERIORITY||Risk Difference (RD)|4.27|||||TWO_SIDED|95.0|-6.722|12.959|||||95% confidence intervals for risk difference utilized Newcombe estimation method.|||12.959|-6.722|
72391012|NCT04518306|144289716|SUPERIORITY||Risk Difference (RD)|3.73|||||TWO_SIDED|95.0|-7.158|12.133|||||95% confidence intervals for risk difference utilized Newcombe estimation method.|||12.133|-7.158|
72391013|NCT04518306|144289717|SUPERIORITY||Risk Difference (RD)|1.43|||||TWO_SIDED|95.0|-8.585|8.916||||||||8.916|-8.585|
72391014|NCT04518306|144289717|SUPERIORITY||Risk Difference (RD)|-1.4|||||TWO_SIDED|95.0|-11.077|5.161||||||||5.161|-11.077|
72391015|NCT04518306|144289718|SUPERIORITY||Risk Difference (RD)|-3.82|||<|0.0001|TWO_SIDED|95.0|-17.664|8.366|||GEE procedure|||||8.366|-17.664|<0.0001
72391016|NCT04518306|144289718|SUPERIORITY||LS Means|5.42|||<|0.0001|TWO_SIDED|95.0|-9.04|17.981|||GEE procedure|||||17.981|-9.040|<0.0001
72391017|NCT03000439|144289739|OTHER||Hazard Ratio (HR)|0.633|||=|0.1171|TWO_SIDED|95.0|0.296|1.354||1-sided p-value is provided.|Unstratified log-rank test||Hazard ratio and 95% CI was based on Cox proportional hazards model with treatment group as covariate. Hazard ratio \< 1 indicates a reduction in hazard ratio in favor of Tofacitinib 5 mg BID to Placebo.|||1.354|0.296|= 0.1171
72391018|NCT03000439|144289740|OTHER||Difference in percentage|0.7|||||TWO_SIDED|95.0|-12.2|13.6|||||The 95% CIs for the differences between the treatment groups were generated using Greenwood's formula.|DB Week 4||13.6|-12.2|
72391019|NCT03000439|144289740|OTHER||Difference in percentage|-8.3|||||TWO_SIDED|95.0|-27.9|11.3|||||The 95% CIs for the differences between the treatment groups were generated using Greenwood's formula.|DB Week 8||11.3|-27.9|
72391020|NCT03000439|144289740|OTHER||Difference in percentage|-10.8|||||TWO_SIDED|95.0|-33.2|11.6|||||The 95% CIs for the differences between the treatment groups were generated using Greenwood's formula.|DB Week 12||11.6|-33.2|
72391021|NCT03000439|144289740|OTHER||Difference in percentage|-13.7|||||TWO_SIDED|95.0|-37.2|9.8|||||The 95% CIs for the differences between the treatment groups were generated using Greenwood's formula.|DB Week 16||9.8|-37.2|
72391022|NCT03000439|144289740|OTHER||Difference in percentage|-13.2|||||TWO_SIDED|95.0|-37.9|11.5|||||The 95% CIs for the differences between the treatment groups were generated using Greenwood's formula.|DB Week 20||11.5|-37.9|
72391023|NCT03000439|144289740|OTHER||Difference in percentage|-13.2|||||TWO_SIDED|95.0|-37.9|11.5|||||The 95% CIs for the differences between the treatment groups were generated using Greenwood's formula.|DB Week 24||11.5|-37.9|
72391024|NCT03000439|144289740|OTHER||Difference in percentage|-9.4|||||TWO_SIDED|95.0|-34.5|15.6|||||The 95% CIs for the differences between the treatment groups were generated using Greenwood's formula.|DB Week 28||15.6|-34.5|
72450438|NCT00303459|144420600|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.01||||0.9566|TWO_SIDED|95.0|-0.42|0.39|||Wilcoxon (Mann-Whitney)|||||0.39|-0.42|0.9566
72450439|NCT00303459|144420601|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.02||||0.5571|TWO_SIDED|95.0|-0.036|0.076|||Wilcoxon (Mann-Whitney)|||||0.076|-0.036|0.5571
72450440|NCT00303459|144420602|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.2||||0.4086|TWO_SIDED|95.0|-3.7|4.0|||Wilcoxon (Mann-Whitney)|||||4.0|-3.7|0.4086
72619644|NCT01104870|144770127|SUPERIORITY_OR_OTHER|||||||0.95|TWO_SIDED|||||Primary comparisons are between Dose Group 1 \& Dose Group 3 and Dose Group 1 \& Dose Group 2. The study is not powered to test for a difference between Dose Group 2 \& Dose Group 3.|Wilcoxon (Mann-Whitney)|||Peak total pulmonary resistance index (TPRI) is defined as the TPRI value observed during exercise at the highest matching wattage achieved at both Baseline and Week 12. Where peak wattage cannot be matched, the closest higher wattage will be chosen for comparison.||||0.95
72619645|NCT01104870|144770127|SUPERIORITY_OR_OTHER|||||||0.27|TWO_SIDED|||||Primary comparisons are between Dose Group 1 \& Dose Group 3 and Dose Group 1 \& Dose Group 2. The study is not powered to test for a difference between Dose Group 2 \& Dose Group 3.|Wilcoxon (Mann-Whitney)|||Peak total pulmonary resistance index (TPRI) is defined as the TPRI value observed during exercise at the highest matching wattage achieved at both Baseline and Week 12. Where peak wattage cannot be matched, the closest higher wattage will be chosen for comparison.||||0.27
72619646|NCT03093246|144770169|SUPERIORITY||||||<|0.05|TWO_SIDED|95.0|||||Generalized Estimated Equations|||||||<0.05
72619647|NCT03093246|144770170|SUPERIORITY||||||<|0.05|TWO_SIDED|95.0|||||Generalized Estimated Equations|||||||<0.05
72619648|NCT03093246|144770171|SUPERIORITY||||||<|0.05|TWO_SIDED|95.0|||||Generalized Estimated Equations|||||||<0.05
72391025|NCT03000439|144289740|OTHER||Difference in percentage|-14.0|||||TWO_SIDED|95.0|-39.5|11.5|||||The 95% CIs for the differences between the treatment groups were generated using Greenwood's formula.|DB Week 32||11.5|-39.5|
72391026|NCT03000439|144289740|OTHER||Difference in percentage|-9.4|||||TWO_SIDED|95.0|-35.5|16.7|||||The 95% CIs for the differences between the treatment groups were generated using Greenwood's formula.|DB Week 36||16.7|-35.5|
72450441|NCT01570361|144420641|SUPERIORITY|||||||0.0009||||||Prior to the final analysis, study had two interim analyses. Hence alpha level is 0.0231 for primary analysis adjusted for the two interim analyses.|Log Rank|One-sided test||||||0.0009
72450442|NCT01570361|144420642|SUPERIORITY|||||||0.0118||||||The alpha level is 0.025 for this secondary endpoint.|Log Rank|One-sided test||||||0.0118
72450443|NCT01570361|144420643|SUPERIORITY|||||||0.0041||||||The alpha level is 0.025 for this secondary endpoint.|Log Rank|One-sided test||||||0.0041
72450444|NCT02846545|144420657|SUPERIORITY||Least Square (LS) Mean|-0.178|||=|0.0004|TWO_SIDED|95.0|-0.28|-0.08|||Mixed Models Analysis|||||-0.08|-0.28|= 0.0004
72619649|NCT04641975|144770175|SUPERIORITY||LS Mean difference|2.22|STANDARD_ERROR_OF_MEAN|1.34||0.121|TWO_SIDED|90.0|-0.15|4.59|||ANCOVA|||Analysis of Covariance (ANCOVA) was performed with change from baseline at week 12 Last Observation Carried Forward (LOCF) as response, treatment group, sex and geographical region as fixed effects and the mean number of micturitions per 24 hours at baseline as covariate.||4.59|-0.15|0.121
72391027|NCT03000439|144289740|OTHER||Difference in percentage|-9.4|||||TWO_SIDED|95.0|-35.5|16.7|||||The 95% CIs for the differences between the treatment groups were generated using Greenwood's formula.|DB Week 40||16.7|-35.5|
72391028|NCT03000439|144289740|OTHER||Difference in percentage|-15.0|||||TWO_SIDED|95.0|-41.8|11.8|||||The 95% CIs for the differences between the treatment groups were generated using Greenwood's formula.|DB Week 44||11.8|-41.8|
72391029|NCT03000439|144289740|OTHER||Difference in percentage|-15.0|||||TWO_SIDED|95.0|-41.8|11.8|||||The 95% CIs for the differences between the treatment groups were generated using Greenwood's formula.|DB Week 48||11.8|-41.8|
72391030|NCT03000439|144289740|OTHER||Difference in percentage|-15.0|||||TWO_SIDED|95.0|-41.8|11.8|||||The 95% CIs for the differences between the treatment groups were generated using Greenwood's formula.|DB Week 52||11.8|-41.8|
72391031|NCT03000439|144289743|OTHER||Difference in percentage|-11.41|||||TWO_SIDED|95.0|-28.02|5.21|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR30 at DB Week 4||5.21|-28.02|
72391032|NCT03000439|144289743|OTHER||Difference in percentage|1.5|||||TWO_SIDED|95.0|-18.37|21.36|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR30 at DB Week 8||21.36|-18.37|
72391033|NCT03000439|144289743|OTHER||Difference in percentage|0.46|||||TWO_SIDED|95.0|-22.68|23.6|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR30 at DB Week 12||23.60|-22.68|
72391034|NCT03000439|144289743|OTHER||Difference in percentage|10.14|||||TWO_SIDED|95.0|-13.82|34.1|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR30 at DB Week 16||34.10|-13.82|
72391035|NCT03000439|144289743|OTHER||Difference in percentage|16.24|||||TWO_SIDED|95.0|-8.43|40.92|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR30 at DB Week 20||40.92|-8.43|
72391036|NCT03000439|144289743|OTHER||Difference in percentage|9.45|||||TWO_SIDED|95.0|-15.49|34.39|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR30 at DB Week 24||34.39|-15.49|
72450445|NCT02846545|144420658|SUPERIORITY||LS Mean|-0.09|||=|0.802|TWO_SIDED|95.0|-0.81|0.63|||Mixed Models Analysis|||||0.63|-0.81|= 0.8020
72450446|NCT02846545|144420659|SUPERIORITY||Ratio of hypoglycemia rates|0.9|||=|0.0036|TWO_SIDED|95.0|0.838|0.966|||Poisson regression model|||Hypoglycemia rate was analyzed by using a Poisson regression model with the number of hypoglycemia events through Week 52 as the response, treatment and gender as fixed factors, age and baseline HbA1c as covariates, and the duration of study participation through week 52 in logarithm as an offset variable.||0.966|0.838|= 0.0036
72469704|NCT01262092|144463113|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.2887||||0.035||95.0||||p values \<0.05 considered statistically significant|Mixed Models Analysis|Used proc GLIMMIX to model group by time (6 study visits)||"test null hypothesis that gbp and pla did not differ in terms of opioid-positive urines during the buprenorphine detox.~For the analysis, data from 2 participants in the GBP groups were excluded due to evidence of medication diversion (N=1) and not being maintained on the 1600 mg/day dose of GBP (N=1)."||||0.035
72469705|NCT04147858|144463114|SUPERIORITY|||||||0.539|||||||t-test, 2 sided|||||||0.539
72561901|NCT03259789|144654655|SUPERIORITY||Odds Ratio (OR)|4.18||||0.0001|TWO_SIDED|95.0|1.96|8.92||P-value is presented based on one-sided statistical tests using a 0.025 level of significance|Mixed-effects repeated measures|Mixed-effects repeated measures analysis includes country, treatment, visit, treatment and baseline HbA1c value as fixed effect covariates|The odds ratios of bexagliflozin group over the placebo group at each visit will be estimated from LS means based on the model with the corresponding p-values and their two-sided 95% CIs presented.|Odds ratio at Week 12 was calculated as the odds ratio of bexagliflozin group over placebo group.||8.92|1.96|0.0001
72391037|NCT03000439|144289743|OTHER||Difference in percentage|9.1|||||TWO_SIDED|95.0|-16.13|34.33|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR30 at DB Week 28||34.33|-16.13|
72391038|NCT03000439|144289743|OTHER||Difference in percentage|9.1|||||TWO_SIDED|95.0|-16.13|34.33|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR30 at DB Week 32||34.33|-16.13|
72391039|NCT03000439|144289743|OTHER||Difference in percentage|9.1|||||TWO_SIDED|95.0|-16.13|34.33|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR30 at DB Week 36||34.33|-16.13|
72391040|NCT03000439|144289743|OTHER||Difference in percentage|9.1|||||TWO_SIDED|95.0|-16.13|34.33|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR30 at DB Week 40||34.33|-16.13|
72391041|NCT03000439|144289743|OTHER||Difference in percentage|9.1|||||TWO_SIDED|95.0|-16.13|34.33|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR30 at DB Week 44||34.33|-16.13|
72391042|NCT03000439|144289743|OTHER||Difference in percentage|12.33|||||TWO_SIDED|95.0|-12.91|37.56|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR30 at DB Week 48||37.56|-12.91|
72391043|NCT03000439|144289743|OTHER||Difference in percentage|12.33|||||TWO_SIDED|95.0|-12.91|37.56|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR30 at DB Week 52||37.56|-12.91|
72391044|NCT03000439|144289743|OTHER||Difference in percentage|-11.41|||||TWO_SIDED|95.0|-28.02|5.21|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR50 at DB Week 4||5.21|-28.02|
72391045|NCT03000439|144289743|OTHER||Difference in percentage|4.72|||||TWO_SIDED|95.0|-15.72|25.17|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR50 at DB Week 8||25.17|-15.72|
72391046|NCT03000439|144289743|OTHER||Difference in percentage|0.46|||||TWO_SIDED|95.0|-22.68|23.6|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR50 at DB Week 12||23.60|-22.68|
72391047|NCT03000439|144289743|OTHER||Difference in percentage|13.36|||||TWO_SIDED|95.0|-10.76|37.48|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR50 at DB Week 16||37.48|-10.76|
72391048|NCT03000439|144289743|OTHER||Difference in percentage|19.47|||||TWO_SIDED|95.0|-5.2|44.14|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR50 at DB Week 20||44.14|-5.20|
72391049|NCT03000439|144289743|OTHER||Difference in percentage|9.45|||||TWO_SIDED|95.0|-15.49|34.39|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR50 at DB Week 24||34.39|-15.49|
72391050|NCT03000439|144289743|OTHER||Difference in percentage|9.1|||||TWO_SIDED|95.0|-16.13|34.33|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR50 at DB Week 28||34.33|-16.13|
72391051|NCT03000439|144289743|OTHER||Difference in percentage|9.1|||||TWO_SIDED|95.0|-16.13|34.33|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR50 at DB Week 32||34.33|-16.13|
72391052|NCT03000439|144289743|OTHER||Difference in percentage|9.1|||||TWO_SIDED|95.0|-16.13|34.33|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR50 at DB Week 36||34.33|-16.13|
72391053|NCT03000439|144289743|OTHER||Difference in percentage|9.1|||||TWO_SIDED|95.0|-16.13|34.33|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR50 at DB Week 40||34.33|-16.13|
72391054|NCT03000439|144289743|OTHER||Difference in percentage|12.33|||||TWO_SIDED|95.0|-12.91|37.56|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR50 at DB Week 44||37.56|-12.91|
72619650|NCT04641975|144770176|SUPERIORITY||Mean Difference (Final Values)|-15.51|STANDARD_ERROR_OF_MEAN|18.91||0.43|TWO_SIDED|90.0|-49.47|18.46|||ANCOVA|||ANCOVA was performed with change from baseline at week 12 without LOCF as response, treatment group, sex and geographical region as fixed effects and the mean volume voided per 24 hours at baseline as covariate. Statistically significant treatment difference at 0.10 level for mirabegron vs placebo.||18.46|-49.47|0.430
72619651|NCT04641975|144770176|SUPERIORITY||Mean Difference (Final Values)|-15.51|STANDARD_ERROR_OF_MEAN|18.91||0.43|TWO_SIDED|90.0|-49.47|18.46|||ANCOVA|||ANCOVA was performed with change from baseline at week 12 with LOCF as response, treatment group, sex and geographical region as fixed effects and the mean volume voided per 24 hours at baseline as covariate. Statistically significant treatment difference at 0.10 level for mirabegron vs placebo.||18.46|-49.47|0.430
72619652|NCT04641975|144770177|SUPERIORITY||Mean Difference (Final Values)|2.58|STANDARD_ERROR_OF_MEAN|31.08||0.935|TWO_SIDED|90.0|-53.23|58.38|||ANCOVA|||ANCOVA was performed with change from baseline at week 12 without LOCF as response, treatment group, sex and geographical region as fixed effects and the mean volume voided per 24 hours at baseline as covariate. Statistically significant treatment difference at 0.10 level for mirabegron vs placebo.||58.38|-53.23|0.935
72619653|NCT04641975|144770177|SUPERIORITY||Mean Difference (Final Values)|2.58|STANDARD_ERROR_OF_MEAN|31.08||0.935|TWO_SIDED|90.0|-53.23|58.38|||ANCOVA|||ANCOVA was performed with change from baseline at week 12 with LOCF as response, treatment group, sex and geographical region as fixed effects and the mean volume voided per 24 hours at baseline as covariate. Statistically significant treatment difference at 0.10 level for mirabegron vs placebo.||58.38|-53.23|0.935
72619654|NCT04641975|144770178|SUPERIORITY||Mean Difference (Final Values)|-1.04|STANDARD_ERROR_OF_MEAN|0.53||0.073|TWO_SIDED|90.0|-1.99|-0.1|||ANCOVA|||ANCOVA was performed with change from baseline at week 12 without LOCF as response, treatment group, sex and geographical region as fixed effects and the mean volume voided per 24 hours at baseline as covariate. Statistically significant treatment difference at 0.10 level for mirabegron vs placebo.||-0.10|-1.99|0.073
72619655|NCT04641975|144770178|SUPERIORITY||Mean Difference (Final Values)|-1.0|STANDARD_ERROR_OF_MEAN|0.45||0.044|TWO_SIDED|90.0|-1.8|-0.2|||ANCOVA|||ANCOVA was performed with change from baseline at week 12 with LOCF as response, treatment group, sex and geographical region as fixed effects and the mean volume voided per 24 hours at baseline as covariate. Statistically significant treatment difference at 0.10 level for mirabegron vs placebo.||-0.20|-1.80|0.044
72619656|NCT04641975|144770179|SUPERIORITY||Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.39||0.91|TWO_SIDED|90.0|-0.74|0.64|||ANCOVA|||ANCOVA as performed with change from baseline at week 12 without LOCF as response, treatment group, sex and geographical region as fixed effects and the mean number of daytime incontinence episodes per 24 hours at baseline as covariate. Statistically significant treatment difference at 0.10 level for mirabegron vs placebo.||0.64|-0.74|0.910
72450447|NCT06468982|144420668|SUPERIORITY|To evaluate whether intra-aortic balloon pump catheter support contributes to a more rapid decrease in troponin levels and faster myocardial recovery, daily troponin levels were analyzed using mixed ANOVA.||||||0.05||||||The p-value was adjusted for multiple comparisons, and the threshold value was set at 0.05.|ANOVA|The hypothesis that IABP causes a rapid increase in troponin levels was analyzed using ANOVA, and the p-value was reported.||After testing for normality, the baseline characteristics of the two groups will be analyzed using the Student's t-test or the Mann-Whitney U-test for continuous variables and the chi-square test or Fisher's exact test for categorical variables. Differences between the intra-aortic balloon pump group and the control group in terms of repeated measurements will be analyzed using mixed ANOVA.||||0.05
72619657|NCT04641975|144770179|SUPERIORITY||Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.39||0.91|TWO_SIDED|90.0|-0.74|0.64|||ANCOVA|||ANCOVA as performed with change from baseline at week 12 with LOCF as response, treatment group, sex and geographical region as fixed effects and the mean number of daytime incontinence episodes per 24 hours at baseline as covariate. Statistically significant treatment difference at 0.10 level for mirabegron vs placebo.||0.64|-0.74|0.910
72450448|NCT06468982|144420669|OTHER||Hazard Ratio, log|0.55|||<|0.05|TWO_SIDED|95.0|0.38|0.78|||Wilcoxon (Mann-Whitney)|||The prognostic value of risk factors for in-hospital mortality was evaluated by multivariate logistic regression analysis||0.78|0.38|<0.05
72450449|NCT02492711|144420686|SUPERIORITY||Hazard Ratio (HR)|0.76||||0.0334|TWO_SIDED|95.0|0.593|0.979|||Log Rank|Stratified Log-Rank Test|Stratified Cox Proportional Model|||0.979|0.593|0.0334
72450450|NCT02492711|144420687|SUPERIORITY||Hazard Ratio (HR)|0.95||||0.6204|TWO_SIDED|95.0|0.774|1.165|||Log Rank|Stratified Log-Rank Test|Stratified Cox Proportional Model|||1.165|0.774|0.6204
72619658|NCT04641975|144770180|SUPERIORITY||Mean Difference (Final Values)|2.48|STANDARD_ERROR_OF_MEAN|0.85||0.012|TWO_SIDED|90.0|0.97|3.99|||ANCOVA|||ANCOVA was performed with change from baseline at week 12 without LOCF as response, treatment group, sex and geographical region as fixed effects and the mean number of daytime micturitions per 24 hours at baseline as covariate. Statistically significant treatment difference at 0.10 level for mirabegron vs placebo.||3.99|0.97|0.012
72370348|NCT04413617|144251183|SUPERIORITY||Mean Difference (Final Values)|-0.35|STANDARD_ERROR_OF_MEAN|0.163||0.0158|TWO_SIDED|90.0|-0.62|-0.08|||Mixed Model Repeated Measures|||The primary clinical hypothesis is that mean decrease at Week 12 in DAS28-CRP score in one or both combo arms exceeds the mean decrease in the reference (tofacitinib) treatment arm, regardless of occurrence of intercurrent events. The null hypothesis is that the mean decrease in DAS28-CRP score at Week 12 is identical in the control (tofacitinib arm) and combination arms.||-0.08|-0.62|0.0158
72450451|NCT02492711|144420689|SUPERIORITY||Hazard Ratio (HR)|0.7||||0.0014|TWO_SIDED|95.0|0.556|0.87|||Log Rank|Stratified Log-Rank Test|Stratified Cox Proportional Model|||0.870|0.556|0.0014
72450452|NCT01116895|144420709|OTHER||Least square mean difference|-2.2||||0.89|TWO_SIDED|95.0|-32.6|28.2|||ANOVA|||||28.2|-32.6|0.89
72450453|NCT01116895|144420709|OTHER||Least square mean difference|4.5||||0.77|TWO_SIDED|95.0|-26.2|35.3|||ANOVA|||||35.3|-26.2|0.77
72450454|NCT01116895|144420709|OTHER||Least square mean difference|-6.7||||0.65|TWO_SIDED|95.0|-36.2|22.8|||ANOVA|||||22.8|-36.2|0.65
72450455|NCT03154190|144420716|SUPERIORITY||Hazard Ratio (HR)|0.3|||||TWO_SIDED|95.0|0.2|0.47|||Regression, Cox|||||0.47|0.20|
72469706|NCT04147858|144463114|SUPERIORITY|||||||0.425|||||||t-test, 2 sided|||||||0.425
72450456|NCT03154190|144420717|SUPERIORITY||Hazard Ratio (HR)|0.48|||||TWO_SIDED|95.0|0.3|0.75|||Regression, Cox|||||0.75|0.30|
72450457|NCT03154190|144420720|SUPERIORITY||Risk Ratio (RR)|0.45|||||TWO_SIDED|95.0|0.33|0.62||||||||0.62|0.33|
72450458|NCT03154190|144420722|SUPERIORITY||Risk Ratio (RR)|0.5|||||TWO_SIDED|95.0|0.36|0.7||||||||0.70|0.36|
72450459|NCT03154190|144420727|SUPERIORITY||Odds Ratio (OR)|4.46|||||TWO_SIDED|95.0|1.88|10.55||||||||10.55|1.88|
72450460|NCT00670241|144420772|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|3.42|||<|0.001|TWO_SIDED|95.0|2.05|5.7|||Cochran-Mantel-Haenszel|||||5.70|2.05|< 0.001
72450461|NCT00670241|144420773|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|3.51|||<|0.001|TWO_SIDED|98.33|1.46|8.4|||Cochran-Mantel-Haenszel|||||8.40|1.46|<0.001
72450462|NCT00670241|144420774|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-14.7|||<|0.001|TWO_SIDED|98.33|-22.6|-6.9|||ANOVA|||||-6.90|-22.6|<0.001
72450463|NCT05850052|144420809|SUPERIORITY||Odds Ratio (OR)|1.24||||0.26|TWO_SIDED|95.0|0.85|1.79|||proportional-odds cumulative logit model|||||1.79|0.85|0.26
72619659|NCT04641975|144770180|SUPERIORITY||Mean Difference (Final Values)|2.46|STANDARD_ERROR_OF_MEAN|0.77||0.007|TWO_SIDED|90.0|1.1|3.82|||ANCOVA|||ANCOVA was performed with change from baseline at week 12 with LOCF as response, treatment group, sex and geographical region as fixed effects and the mean number of daytime micturitions per 24 hours at baseline as covariate. Statistically significant treatment difference at 0.10 level for mirabegron vs placebo.||3.82|1.10|0.007
72619660|NCT04641975|144770181|SUPERIORITY||Rate ratio|0.2||||0.105|TWO_SIDED|90.0|0.04|1.02|||Binomial regression|||Without LOCF: From a negative binomial regression model including treatment group, sex and region as factors and the log baseline rate of number of dry days (the log of the ratio of dry days at baseline and number of diary days at baseline) as covariate.||1.02|0.04|0.105
72450464|NCT05850052|144420810|SUPERIORITY||incidence rate ratio|1.02||||0.86|TWO_SIDED|97.5|0.82|1.27|||proportional-odds cumulative logit model|||||1.27|0.82|0.86
72450465|NCT05850052|144420811|SUPERIORITY||Risk Ratio (RR)|3.1||||0.36|TWO_SIDED|95.0|0.32|30.0|||Fisher Exact|||||30|0.32|0.36
72450466|NCT05552508|144420883|OTHER|||||||0.0327|||||||t-test, 2 sided|||All participants||||0.0327
72450467|NCT05552508|144420883|OTHER|||||||0.0359|||||||t-test, 2 sided|||Participants with \>=4 mucus plugs||||0.0359
72450468|NCT05552508|144420883|OTHER|||||||0.1088|||||||t-test, 2 sided|||Participants with \<4 mucus plugs||||0.1088
72450469|NCT05552508|144420883|OTHER|||||||0.0391|||||||t-test, 2 sided|||Non-OCS-dependent participants||||0.0391
72450470|NCT05552508|144420884|OTHER|||||||0.0423|||||||t-test, 2 sided|||||||0.0423
72450471|NCT05552508|144420885|OTHER|||||||0.9465|||||||t-test, 2 sided|||||||0.9465
72450472|NCT05552508|144420886|OTHER|||||||0.3455|||||||t-test, 2 sided|||||||0.3455
72450473|NCT05552508|144420887|OTHER|||||||0.2484|||||||t-test, 2 sided|||||||0.2484
72450474|NCT05552508|144420888|OTHER|||||||0.9405|||||||t-test, 2 sided|||||||0.9405
72450475|NCT05552508|144420889|OTHER|||||||0.6867|||||||t-test, 2 sided|||||||0.6867
72450476|NCT05552508|144420890|OTHER|||||||0.7554|||||||t-test, 2 sided|||||||0.7554
72450477|NCT00971087|144420991|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|3D + s2D will be considered non-inferior to 2D FFDM if the lower limit one-sided 95% CI for the difference in AUCs (3DS minus 2D FFDM) is greater than -0.05. That is, our null hypothesis is that the AUC for 3D + s2D is 0.05 less than the AUC for 2D FFDM. A difference of 0.05 is considered a clinically significant difference.||||||0.009|||||||MRMC ROC Analysis|||A multi-reader, multi-case ROC analysis will be used to compare 3D + s2D to 2D FFDM. The areas under the curve (AUC) will be used to compare ROC performance.||||0.009
72450478|NCT00971087|144420992|NON_INFERIORITY|A multi-reader, multi-case ROC analysis will be used to compare 3DS to 2D FFDM. The areas under the curve (AUC) will be used to compare ROC performance. 3DS will be considered non-inferior to 2D FFDM if the lower limit onesided 95% CI for the difference in AUCs (3DS minus 2D FFDM) is greater than -0.05.||||||0.045|||||||MRMC ROC Analysis|||||||0.045
72450479|NCT01199133|144421006|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|0.01|||>|0.05||95.0|-0.41|0.43|||ANCOVA|||||0.43|-0.41|> 0.05
72450480|NCT01447719|144421021|SUPERIORITY_OR_OTHER_LEGACY||Sensitivity|92.0|||||TWO_SIDED|95.0|78.0|98.0|||||95% CI calculated by Wilson score method|Proportion of subjects who had a positive scan based on majority of 5 blinded readers||98|78|
72450481|NCT01447719|144421022|SUPERIORITY_OR_OTHER_LEGACY||Specificity|100.0|||||TWO_SIDED|95.0|80.0|100.0|||||95% CI calculated by Wilson score method|Proportion of subjects who had a negative scan based on majority of 5 blinded readers||100|80|
72450482|NCT01447719|144421023|SUPERIORITY_OR_OTHER_LEGACY||Correlation coefficient|0.76|STANDARD_ERROR_OF_MEAN|0.133|<|0.0001|TWO_SIDED|95.0|0.62|0.85||A one-sided test (rho \> 0) was performed with a significance level of alpha=0.05 to assess a significant correlation.|Spearman's Rank Order Correlation test|Asymptotic standard error and 95 percent CI used Fisher z-transformation.||Spearman's Rank Order Correlation of the median semiquantitative read (three readers) and the quantitative IHC measurement of cortical amyloid plaque density averaged across six brain regions.||0.85|0.62|<0.0001
72450483|NCT01447719|144421024|SUPERIORITY_OR_OTHER_LEGACY||Sensitivity|96.0|||||TWO_SIDED|95.0|80.0|100.0||||||Proportion of subjects who had a positive scan based on majority of 5 blinded readers||100|80|
72450484|NCT01447719|144421025|SUPERIORITY_OR_OTHER_LEGACY||Specificity|100.0|||||TWO_SIDED|95.0|78.0|100.0||||||Proportion of subjects who had a negative scan based on majority of 5 blinded readers||100|78|
72450485|NCT02938923|144421054|SUPERIORITY||Mean Difference (Final Values)|2.19||||0.853|TWO_SIDED|95.0|-21.16|25.54||Unadjusted p-value|Mixed Models Analysis|t (df, 112) = 0.19|Difference between the changes (EX+T - EX+P)|Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with an unstructured covariance structure.||25.54|-21.16|0.853
72469707|NCT04147858|144463115|SUPERIORITY|||||||0.824|||||||t-test, 2 sided|||||||0.824
72469708|NCT04147858|144463115|SUPERIORITY|||||||1|||||||t-test, 2 sided|||||||1.000
72469709|NCT04147858|144463116|SUPERIORITY|||||||0.297|||||||t-test, 2 sided|||||||0.297
72469710|NCT04147858|144463116|SUPERIORITY|||||||0.603|||||||t-test, 2 sided|||||||0.603
72469711|NCT04147858|144463117|SUPERIORITY|||||||0.871|||||||t-test, 2 sided|||||||0.871
72469712|NCT04147858|144463117|SUPERIORITY|||||||0.352|||||||t-test, 2 sided|||||||0.352
72469713|NCT04147858|144463118|SUPERIORITY|||||||1|||||||t-test, 2 sided|||||||1.000
72469714|NCT04147858|144463118|SUPERIORITY|||||||0.626|||||||t-test, 2 sided|||||||0.626
72469715|NCT04147858|144463119|SUPERIORITY|||||||0.059|||||||t-test, 2 sided|||||||0.059
72450486|NCT02938923|144421054|SUPERIORITY||Mean Difference (Final Values)|5.04||||0.767|TWO_SIDED|95.0|-28.57|38.65||Unadjusted p-value|Mixed Models Analysis|t (df, 112) = 0.30|Difference between the changes (EX+T - EUC)|Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with an unstructured covariance structure.||38.65|-28.57|0.767
72450487|NCT02938923|144421054|SUPERIORITY||Mean Difference (Final Values)|2.84||||0.868|TWO_SIDED|95.0|-30.93|36.62||Unadjusted p-value|Mixed Models Analysis|t (df,112) = 0.17|Difference between the changes (EX+P - EUC)|Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with an unstructured covariance structure.||36.62|-30.93|0.868
72450488|NCT02938923|144421054|SUPERIORITY||Mean Difference (Final Values)|0.63||||0.96|TWO_SIDED|95.0|-24.26|25.52||Unadjusted p-value|Mixed Models Analysis|t (df, 217) = 0.05|Difference between the changes (EX+T - EX+P)|Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with a Toeplitz covariance structure in the model with covariates.||25.52|-24.26|0.960
72450489|NCT02938923|144421054|SUPERIORITY||Mean Difference (Final Values)|8.42||||0.63|TWO_SIDED|95.0|-25.97|42.82||Unadjusted p-value|Mixed Models Analysis|t (df, 217) = 0.48|Difference between the changes (EX+T - EUC)|Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with a Toeplitz covariance structure in the model with covariates.||42.82|-25.97|0.630
72450490|NCT02938923|144421054|SUPERIORITY||Mean Difference (Final Values)|7.79||||0.657|TWO_SIDED|95.0|-26.77|42.36||Unadjusted p-value|Mixed Models Analysis|t (df, 217) = 0.44|Difference between the changes (EX+P - EUC)|Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with a Toeplitz covariance structure in the model with covariates.||42.36|-26.77|0.657
72450491|NCT02938923|144421054|SUPERIORITY||Mean Difference (Final Values)|-5.08||||0.627|TWO_SIDED|95.0|-25.72|15.56||Unadjusted p-value|Mixed Models Analysis|t (df, 112) = -0.49|Difference between the changes (EX+T - EX+P)|Comparison based on contrasts between two groups at baseline to three months from mixed model ANOVA with an unstructured covariance structure.||15.56|-25.72|0.627
72450492|NCT02938923|144421054|SUPERIORITY||Mean Difference (Final Values)|-13.5||||0.364|TWO_SIDED|95.0|-42.86|15.86||Unadjusted p-value|Mixed Models Analysis|t (df, 112) = -0.91|Difference between the changes (EX+T - EUC)|Comparison based on contrasts between two groups at baseline to three months from mixed model ANOVA with an unstructured covariance structure.||15.86|-42.86|0.364
72450493|NCT02938923|144421054|SUPERIORITY||Mean Difference (Final Values)|-8.42||||0.574|TWO_SIDED|95.0|-38.0|21.15||Unadjusted p-value|Mixed Models Analysis|t (df, 112) = -0.56|Difference between the changes (EX+P - EUC)|Comparison based on contrasts between two groups at baseline to three months from mixed model ANOVA with an unstructured covariance structure.||21.15|-38.00|0.574
72450494|NCT02938923|144421054|SUPERIORITY||Mean Difference (Final Values)|-5.51||||0.557|TWO_SIDED|95.0|-23.96|12.94||Unadjusted p-value|Mixed Models Analysis|t (df, 217) = -0.59|Difference between the changes (EX+T - EX+P)|Comparison based on contrasts between two groups at baseline to three months from mixed model ANOVA with a Toeplitz covariance structure in the model with covariates.||12.94|-23.96|0.557
72450495|NCT02938923|144421054|SUPERIORITY||Mean Difference (Final Values)|-13.65||||0.302|TWO_SIDED|95.0|-39.64|12.35||Unadjusted p-value|Mixed Models Analysis|t (df, 217) = -1.03|Difference between the changes (EX+T - EUC)|Comparison based on contrasts between two groups at baseline to three months from mixed model ANOVA with a Toeplitz covariance structure in the model with covariates.||12.35|-39.64|0.302
72619661|NCT04641975|144770181|SUPERIORITY||Rate ratio|0.22||||0.111|TWO_SIDED|90.0|0.05|1.05|||Binomial regression|||With LOCF: From a negative binomial regression model including treatment group, sex and region as factors and the log baseline rate of number of dry days (the log of the ratio of dry days at baseline and number of diary days at baseline) as covariate.||1.05|0.05|0.111
72450496|NCT02938923|144421054|SUPERIORITY||Mean Difference (Final Values)|-8.14||||0.541|TWO_SIDED|95.0|-34.33|18.06||Unadjusted p-value|Mixed Models Analysis|t (df, 217) = -0.61|Difference between the changes (EX+P - EUC)|Comparison based on contrasts between two groups at baseline to three months from mixed model ANOVA with a Toeplitz covariance structure in the model with covariates.||18.06|-34.33|0.541
72450497|NCT02938923|144421055|SUPERIORITY||Mean Difference (Final Values)|357.72||||0.336|TWO_SIDED|95.0|-375.75|1091.19||Unadjusted p-value|Mixed Models Analysis|t (df, 112) = 0.97|Difference between the changes (EX+T - EX+P)|Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with an unstructured covariance structure.||1091.19|-375.75|0.336
72450498|NCT02938923|144421055|SUPERIORITY||Mean Difference (Final Values)|936.93||||0.09|TWO_SIDED|95.0|-147.56|2021.42||Unadjusted p-value|Mixed Models Analysis|t (df, 112) = 1.71|Difference between the changes (EX+T - EUC)|Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with an unstructured covariance structure.||2021.42|-147.56|0.090
72469716|NCT04147858|144463119|SUPERIORITY|||||||0.726|||||||t-test, 2 sided|||||||0.726
72469717|NCT04147858|144463120|SUPERIORITY|||||||0.888|||||||t-test, 2 sided|||||||0.888
72469718|NCT04147858|144463120|SUPERIORITY|||||||0.832|||||||t-test, 2 sided|||||||0.832
72469719|NCT04147858|144463121|SUPERIORITY|||||||0.536|||||||t-test, 2 sided|||||||0.536
72469720|NCT04147858|144463121|SUPERIORITY|||||||0.982|||||||t-test, 2 sided|||||||0.982
72469721|NCT04147858|144463122|SUPERIORITY|||||||0.19|||||||t-test, 2 sided|||||||0.190
72469722|NCT04147858|144463122|SUPERIORITY|||||||0.764|||||||t-test, 2 sided|||||||0.764
72469723|NCT04147858|144463123|SUPERIORITY|||||||0.097|||||||t-test, 2 sided|||||||0.097
72469724|NCT04147858|144463123|SUPERIORITY|||||||0.849|||||||t-test, 2 sided|||||||0.849
72469725|NCT03771638|144463124|SUPERIORITY|Minimum detectable effects: Under assumptions of the adherence of DBS TFV-DP levels \>=700 fmol/punch in the control condition as 60% and intraclass correlation of repeated binary measures of DBS TFV-DP of 0.69, and retention of 80% of participants at 24 weeks, we will have 80% power in 2-sided tests with a type-1 error rate of 5% to detect average between-group differences in adherence of 23 percentage points.|Risk Ratio (RR)|1.01||||0.94|TWO_SIDED|95.0|0.75|1.36||GEE poisson models with robust standard errors were used to assess DBS adherence rates, averaged across visits.|GEE Poisson models|||Null hypothesis: no difference in PrEP adherence levels between DOT Diary Intervention and Control arms||1.36|0.75|0.94
72469957|NCT00940875|144463862|SUPERIORITY_OR_OTHER|||||||0.4798|TWO_SIDED||||||Log Rank|||Difference between treatment groups in PFS||||0.4798
72391055|NCT03000439|144289743|OTHER||Difference in percentage|12.33|||||TWO_SIDED|95.0|-12.91|37.56|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR50 at DB Week 48||37.56|-12.91|
72391056|NCT03000439|144289743|OTHER||Difference in percentage|12.33|||||TWO_SIDED|95.0|-12.91|37.56|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR50 at DB Week 52||37.56|-12.91|
72391057|NCT03000439|144289743|OTHER||Difference in percentage|-13.82|||||TWO_SIDED|95.0|-38.14|10.49|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR70 at DB Week 4||10.49|-38.14|
72391058|NCT03000439|144289743|OTHER||Difference in percentage|-9.56|||||TWO_SIDED|95.0|-32.28|13.15|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR70 at DB Week 8||13.15|-32.28|
72391059|NCT03000439|144289743|OTHER||Difference in percentage|-0.23|||||TWO_SIDED|95.0|-24.7|24.24|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR70 at DB Week 12||24.24|-24.70|
72391060|NCT03000439|144289743|OTHER||Difference in percentage|5.88|||||TWO_SIDED|95.0|-19.31|31.06|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR70 at DB Week 16||31.06|-19.31|
72391061|NCT03000439|144289743|OTHER||Difference in percentage|19.12|||||TWO_SIDED|95.0|-5.81|44.06|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR70 at DB Week 20||44.06|-5.81|
72391062|NCT03000439|144289743|OTHER||Difference in percentage|1.96|||||TWO_SIDED|95.0|-23.55|27.47|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR70 at DB Week 24||27.47|-23.55|
72391063|NCT03000439|144289743|OTHER|The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|Difference in percentage|15.21|||||TWO_SIDED|95.0|-10.05|40.46|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR70 at DB Week 28||40.46|-10.05|
72450499|NCT02938923|144421055|SUPERIORITY||Mean Difference (Final Values)|579.21||||0.297|TWO_SIDED|95.0|-515.36|1673.78||Unadjusted p-value|Mixed Models Analysis|t (df, 112) = 1.05|Difference between the changes (EX+P - EUC)|Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with an unstructured covariance structure.||1673.78|-515.36|0.297
72450500|NCT02938923|144421055|SUPERIORITY||Mean Difference (Final Values)|383.36||||0.245|TWO_SIDED|95.0|-266.06|1032.79||Unadjusted p-value|Mixed Models Analysis|t (df, 107) = 1.17|Difference between the changes (EX+T - EX+P)|Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with a Heterogeneous Toeplitz covariance structure in the model with covariates.||1032.79|-266.06|0.245
72450501|NCT02938923|144421055|SUPERIORITY||Mean Difference (Final Values)|836.64||||0.069|TWO_SIDED|95.0|-67.04|1740.32||Unadjusted p-value|Mixed Models Analysis|t (df, 107) = 1.84|Difference between the changes (EX+T - EUC)|Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with a Heterogeneous Toeplitz covariance structure in the model with covariates.||1740.32|-67.04|0.069
72450502|NCT02938923|144421055|SUPERIORITY||Mean Difference (Final Values)|453.28||||0.327|TWO_SIDED|95.0|-459.13|1365.68||Unadjusted p-value|Mixed Models Analysis|t (df, 107) = 0.98|Difference between changes (EX+P - EUC)|Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with a Heterogeneous Toeplitz covariance structure in the model with covariates.||1365.68|-459.13|0.327
72450503|NCT02938923|144421056|SUPERIORITY||Mean Difference (Final Values)|17.16||||0.934|TWO_SIDED|95.0|-391.74|426.05||Unadjusted p-value|Mixed Models Analysis|t (df, 112) = 0.08|Difference between the changes (EX+T - EX+P)|Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with an unstructured covariance structure.||426.05|-391.74|0.934
72619662|NCT01546987|144770196|SUPERIORITY||Hazard Ratio (HR)|0.83||||0.55|TWO_SIDED|95.0|0.47|1.48||One-sided significance level = 0.05|Log Rank||Reference level = ADT + RT|Revised protocol due to early accrual closure (September 2014) computes that seventy events with five years of additional follow-up after early accrual closure provides 70% power (at one-sided alpha = 0.05) to detect a 40% reduction in the assumed rate control arm rate of is 0.08/year.||1.48|0.47|0.55
72391064|NCT03000439|144289743|OTHER||Difference in percentage|12.33|||||TWO_SIDED|95.0|-12.91|37.56|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR70 at DB Week 32||37.56|-12.91|
72469726|NCT03771638|144463125|OTHER||Kappa statistic|0.49|||||TWO_SIDED|95.0|0.36|0.62|||Kappa|||Kappa statistic to assess concordance between DBS measurement and self-reported PrEP use||0.62|0.36|
72391065|NCT03000439|144289743|OTHER||Difference in percentage|9.1|||||TWO_SIDED|95.0|-16.13|34.33|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR70 at DB Week 36||34.33|-16.13|
72391066|NCT03000439|144289743|OTHER||Difference in percentage|12.33|||||TWO_SIDED|95.0|-12.91|37.56|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR70 at DB Week 40||37.56|-12.91|
72391067|NCT03000439|144289743|OTHER||Difference in percentage|12.33|||||TWO_SIDED|95.0|-12.91|37.56|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR70 at DB Week 44||37.56|-12.91|
72391068|NCT03000439|144289743|OTHER||Difference in percentage|12.33|||||TWO_SIDED|95.0|-12.91|37.56|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR70 at DB Week 48||37.56|-12.91|
72391069|NCT03000439|144289743|OTHER||Difference in percentage|12.33|||||TWO_SIDED|95.0|-12.91|37.56|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR70 at DB Week 52||37.56|-12.91|
72391070|NCT03000439|144289743|OTHER||Difference in percentage|-19.82|||||TWO_SIDED|95.0|-44.09|4.46|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR90 at DB Week 4||4.46|-44.09|
72391071|NCT03000439|144289743|OTHER||Difference in percentage|-17.28|||||TWO_SIDED|95.0|-40.19|5.63|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR90 at DB Week 8||5.63|-40.19|
72450504|NCT02938923|144421056|SUPERIORITY||Mean Difference (Final Values)|562.64||||0.068|TWO_SIDED|95.0|-42.02|1167.31||Unadjusted p-value|Mixed Models Analysis|t (df, 112) = 1.84|Difference between the changes (EX+T - EUC)|Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with an unstructured covariance structure.||1167.31|-42.02|0.068
72450505|NCT02938923|144421056|SUPERIORITY||Mean Difference (Final Values)|545.49||||0.079|TWO_SIDED|95.0|-64.81|1155.79||Unadjusted p-value|Mixed Models Analysis|t (df, 112) = 1.77|Difference between the changes (EX+P - EUC)|Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with an unstructured covariance structure.||1155.79|-64.81|0.079
72450506|NCT02938923|144421056|SUPERIORITY||Mean Difference (Final Values)|33.73||||0.867|TWO_SIDED|95.0|-365.4|432.86||Unadjusted p-value|Mixed Models Analysis|t (df, 102) = 0.17|Difference between the changes (EX+T - EX+P)|Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with an unstructured covariance structure in the model with covariates.||432.860|-365.40|0.867
72450507|NCT02938923|144421056|SUPERIORITY||Mean Difference (Final Values)|665.75||||0.02|TWO_SIDED|95.0|105.68|1225.81||Unadjusted p-value|Mixed Models Analysis|t (df, 102) = 2.36|Difference between the changes (EX+T - EUC)|Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with an unstructured covariance structure in the model with covariates.||1225.81|105.68|0.020
72450508|NCT02938923|144421056|SUPERIORITY||Mean Difference (Final Values)|632.02||||0.029|TWO_SIDED|95.0|66.38|1197.66||Unadjusted p-value|Mixed Models Analysis|t (df, 102) = 2.22|Difference between the changes (EX+P - EUC)|Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with an unstructured covariance structure in the model with covariates.||1197.66|66.38|0.029
72450509|NCT02938923|144421057|SUPERIORITY||Mean Difference (Final Values)|0.7||||0.946|TWO_SIDED|95.0|-19.61|21.01||Unadjusted p-value|Mixed Models Analysis|t (df, 110) = 0.07|Difference between the changes (EX+T - EX+P)|Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with an unstructured covariance structure.||21.01|-19.61|0.946
72450510|NCT02938923|144421057|SUPERIORITY||Mean Difference (Final Values)|24.44||||0.094|TWO_SIDED|95.0|-4.25|53.13||Unadjusted p-value|Mixed Models Analysis|t (df, 110) = 1.69|Difference between the changes (EX+T - EUC)|Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with an unstructured covariance structure.||53.13|-4.25|0.094
72450511|NCT02938923|144421057|SUPERIORITY||Mean Difference (Final Values)|23.74||||0.107|TWO_SIDED|95.0|-5.19|52.67||Unadjusted p-value|Mixed Models Analysis|t (df, 110) = 1.63|Difference between the changes (EX+P - EUC)|Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with an unstructured covariance structure.||52.67|-5.19|0.107
72450512|NCT02938923|144421057|SUPERIORITY||Mean Difference (Final Values)|4.81||||0.627|TWO_SIDED|95.0|-14.68|24.3||Unadjusted p-value|Mixed Models Analysis|t (df, 189) = 0.49|Difference between the changes (EX+T - EX+P)|Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with a Toeplitz covariance structure in the model with covariates.||24.30|-14.68|0.627
72450513|NCT02938923|144421057|SUPERIORITY||Mean Difference (Final Values)|24.91||||0.072|TWO_SIDED|95.0|-2.2|52.01||Unadjusted p-value|Mixed Models Analysis|t (df, 189) = 1.81|Difference between the changes (EX+T - EUC)|Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with a Toeplitz covariance structure in the model with covariates.||52.01|-2.20|0.072
72450514|NCT02938923|144421057|SUPERIORITY||Mean Difference (Final Values)|20.1||||0.149|TWO_SIDED|95.0|-7.29|47.49||Unadjusted p-value|Mixed Models Analysis|t (df, 189) = 1.45|Difference between the changes (EX+P - EUC)|Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with a Toeplitz covariance structure in the model with covariates.||47.49|-7.29|0.149
72619663|NCT01546987|144770197|SUPERIORITY||Hazard Ratio (HR)|0.71||||0.27|TWO_SIDED|95.0|0.38|1.31||Two-sided significance level = 0.05|Log Rank||Reference level = ADT + RT|Revised protocol due to early accrual closure (September 2014) computes that 5-year survival of 78% and annual hazard rate of 0.055 for ADT + RT arm, with five years of additional follow-up after early accrual closure provides 28% power (at two-sided alpha = 0.05) to detect a 33% reduction in failure rate.||1.31|0.38|0.27
72450515|NCT02938923|144421057|SUPERIORITY||Mean Difference (Final Values)|-1.38||||0.849|TWO_SIDED|95.0|-15.71|12.95||Unadjusted p-value|Mixed Models Analysis|t (df, 110) = -0.19|Difference between the changes (EX+T - EX+P)|Comparison based on contrasts between two groups at baseline to three months from mixed model ANOVA with an unstructured covariance structure.||12.95|-15.71|0.849
72450516|NCT02938923|144421057|SUPERIORITY||Mean Difference (Final Values)|15.47||||0.134|TWO_SIDED|95.0|-4.83|35.78||Unadjusted p-value|Mixed Models Analysis|(df, 110) = 1.15|Difference between the changes (EX+T - EUC)|Comparison based on contrasts between two groups at baseline to three months from mixed model ANOVA with an unstructured covariance structure.||35.78|-4.83|0.134
72450517|NCT02938923|144421057|SUPERIORITY||Mean Difference (Final Values)|16.86||||0.107|TWO_SIDED|95.0|-3.68|37.39||Unadjusted p-value|Mixed Models Analysis|t (df, 110) = 1.63|Difference between the changes (EX+P - EUC)|Comparison based on contrasts between two groups at baseline to three months from mixed model ANOVA with an unstructured covariance structure.||37.39|-3.68|0.107
72450518|NCT02938923|144421057|SUPERIORITY||Mean Difference (Final Values)|-0.23||||0.973|TWO_SIDED|95.0|-13.64|13.17||Unadjusted p-value|Mixed Models Analysis|t (df, 189) = -0.03|Difference between the changes (EX+T - EX+P)|Comparison based on contrasts between two groups at baseline to three months from mixed model ANOVA with a Toeplitz covariance structure in the model with covariates.||13.17|-13.64|0.973
72469727|NCT03512197|144463129|SUPERIORITY||Hazard Ratio (HR)|1.0239|||||TWO_SIDED|95.0|0.8|1.31||||||||1.31|0.8|
72469728|NCT03512197|144463130|SUPERIORITY||Hazard Ratio (HR)|0.8728|||||TWO_SIDED|95.0|0.59|1.29||||||||1.29|0.59|
72469729|NCT03512197|144463135|SUPERIORITY||Hazard Ratio (HR)|0.98|||||TWO_SIDED|95.0|0.6|1.63||||||||1.63|0.60|
72469730|NCT03512197|144463136|SUPERIORITY||Hazard Ratio (HR)|1.5866|||||TWO_SIDED|95.0|0.88|2.87||||||||2.87|0.88|
72469731|NCT03512197|144463137|SUPERIORITY||Hazard Ratio (HR)|0.7937|||||TWO_SIDED|95.0|0.41|1.54||||||||1.54|0.41|
72469732|NCT03512197|144463139|SUPERIORITY||Hazard Ratio (HR)|0.93|||||TWO_SIDED|95.0|0.75|1.16||||||partial neutrophil recovery||1.16|0.75|
72469733|NCT03512197|144463139|SUPERIORITY||Hazard Ratio (HR)|0.91|||||TWO_SIDED|95.0|0.72|1.14||||||full neutrophil recovery||1.14|0.72|
72469734|NCT03512197|144463140|SUPERIORITY||Hazard Ratio (HR)|1.15|||||TWO_SIDED|95.0|0.87|1.52||||||partial platelet recovery||1.52|0.87|
72450519|NCT02938923|144421057|SUPERIORITY||Mean Difference (Final Values)|14.49||||0.135|TWO_SIDED|95.0|-4.56|33.54||Unadjusted p-value|Mixed Models Analysis|t (df, 189) = 1.50|Difference between the changes (EX+T - EUC)|Comparison based on contrasts between two groups at baseline to three months from mixed model ANOVA with a Toeplitz covariance structure in the model with covariates.||33.54|-4.56|0.135
72450520|NCT02938923|144421057|SUPERIORITY||Mean Difference (Final Values)|14.72||||0.134|TWO_SIDED|95.0|-4.55|34.0||Unadjusted p-value|Mixed Models Analysis|t (df, 189) = 1.51|Difference between the changes (EX+P - EUC)|Comparison based on contrasts between two groups at baseline to three months from mixed model ANOVA with a Toeplitz covariance structure in the model with covariates.||34.00|-4.55|0.134
72450521|NCT02938923|144421058|SUPERIORITY||Mean Difference (Final Values)|1.21||||0.125|TWO_SIDED|95.0|-0.34|2.76||Unadjusted p-value|Mixed Models Analysis|t (df, 112) = 1.55|Difference between the changes (EX+T - EX+P)|Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with an unstructured covariance structure.||2.76|-0.34|0.125
72450522|NCT02938923|144421058|SUPERIORITY||Mean Difference (Final Values)|0.35||||0.758|TWO_SIDED|95.0|-1.9|2.61||Unadjusted p-value|Mixed Models Analysis|t (df, 112) = 0.31|Difference between the changes (EX+T - EUC)|Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with an unstructured covariance structure.||2.61|-1.90|0.758
72450523|NCT02938923|144421058|SUPERIORITY||Mean Difference (Final Values)|-0.86||||0.455|TWO_SIDED|95.0|-3.12|1.41||Unadjusted p-value|Mixed Models Analysis|t (df, 112) = -0.75|Difference between the changes (EX+P - EUC)|Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with an unstructured covariance structure.||1.41|-3.12|0.455
72450524|NCT02938923|144421058|SUPERIORITY||Mean Difference (Final Values)|1.14||||0.229|TWO_SIDED|95.0|-0.72|3.0||Unadjusted p-value|Mixed Models Analysis|t (df, 214) = 1.21|Difference between the changes (EX+T - EX+P)|Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with an unstructured covariance structure in the model with covariates.||3.00|-0.72|0.229
72450525|NCT02938923|144421058|SUPERIORITY||Mean Difference (Final Values)|0.6||||0.647|TWO_SIDED|95.0|-1.97|3.16||Unadjusted p-value|Mixed Models Analysis|t (df, 214) = 0.46|Difference between the changes (EX+T - EUC)|Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with an unstructured covariance structure in the model with covariates.||3.16|-1.97|0.647
72450526|NCT02938923|144421058|SUPERIORITY||Mean Difference (Final Values)|-0.54||||0.68|TWO_SIDED|95.0|-3.12|2.04||Unadjusted p-value|Mixed Models Analysis|t (df, 214) = -0.41|Difference between the changes (EX+P - EUC)|Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with an unstructured covariance structure in the model with covariates.||2.04|-3.12|0.680
72450527|NCT02938923|144421058|SUPERIORITY||Mean Difference (Final Values)|1.48||||0.052|TWO_SIDED|95.0|-0.02|2.97||Unadjusted p-value|Mixed Models Analysis|t (df, 112) = 1.96|Difference between the changes (EX+T - EX+P)|Comparison based on contrasts between two groups at baseline to three months from mixed model ANOVA with an unstructured covariance structure.||2.97|-0.02|0.052
72450528|NCT02938923|144421058|SUPERIORITY||Mean Difference (Final Values)|0.34||||0.754|TWO_SIDED|95.0|-1.79|2.46||Unadjusted p-value|Mixed Models Analysis|t (df, 112) = 0.31|Difference between the changes (EX+T - EUC)|Comparison based on contrasts between two groups at baseline to three months from mixed model ANOVA with an unstructured covariance structure.||2.46|-1.79|0.754
72450529|NCT02938923|144421058|SUPERIORITY||Mean Difference (Final Values)|-1.14||||0.294|TWO_SIDED|95.0|-3.28|1.0||Unadjusted p-value|Mixed Models Analysis|t (df, 112) = -1.06|Difference between the changes (EX+P - EUC)|Comparison based on contrasts between two groups at baseline to three months from mixed model ANOVA with an unstructured covariance structure.||1.00|-3.28|0.294
72450530|NCT02938923|144421058|SUPERIORITY||Mean Difference (Final Values)|1.46||||0.031|TWO_SIDED|95.0|0.13|2.78||Unadjusted p-value|Mixed Models Analysis|t (df, 214) = 2.17|Difference between the changes (EX+T - EX+P)|Comparison based on contrasts between two groups at baseline to three months from mixed model ANOVA with an unstructured covariance structure in the model with covariates.||2.78|0.13|0.031
72450531|NCT02938923|144421058|SUPERIORITY||Mean Difference (Final Values)|0.3||||0.752|TWO_SIDED|95.0|-1.56|2.16||Unadjusted p-value|Mixed Models Analysis|t (df, 214) = 0.32|Difference between the changes (EX+T - EUC)|Comparison based on contrasts between two groups at baseline to three months from mixed model ANOVA with an unstructured covariance structure in the model with covariates.||2.16|-1.56|0.752
72450532|NCT02938923|144421058|SUPERIORITY||Mean Difference (Final Values)|-1.16||||0.223|TWO_SIDED|95.0|-3.03|0.71||Unadjusted p-value|Mixed Models Analysis|t (df, 214) = -1.22|Difference between the changes (EX+P - EUC)|Comparison based on contrasts between two groups at baseline to three months from mixed model ANOVA with an unstructured covariance structure in the model with covariates.||0.71|-3.03|0.223
72619664|NCT01546987|144770198|SUPERIORITY||Hazard Ratio (HR)|2.29|||<|0.001|TWO_SIDED|95.0|1.54|3.4|||Log Rank||Reference level = ADT + RT arm|||3.40|1.54|<0.001
72450533|NCT02938923|144421059|SUPERIORITY||Mean Difference (Final Values)|0.85||||0.006|TWO_SIDED|95.0|0.24|1.46||Unadjusted p-value|Mixed Models Analysis|t (df, 112) = 2.78|Difference between the changes (EX+T - EX+P)|Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with an unstructured covariance structure.||1.46|0.24|0.006
72450534|NCT02938923|144421059|SUPERIORITY||Mean Difference (Final Values)|0.08||||0.863|TWO_SIDED|95.0|-0.81|0.97||Unadjusted p-value|Mixed Models Analysis|t (df, 112) = 0.17|Difference between the changes (EX+T - EUC)|Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with an unstructured covariance structure.||0.97|-0.81|0.863
72450535|NCT02938923|144421059|SUPERIORITY||Mean Difference (Final Values)|-0.77||||0.091|TWO_SIDED|95.0|-1.67|0.12||Unadjusted p-value|Mixed Models Analysis|t (df, 112) = -1.71|Difference between the changes (EX+P - EUC)|Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with an unstructured covariance structure.||0.12|-1.67|0.091
72469735|NCT03512197|144463140|SUPERIORITY||Hazard Ratio (HR)|0.82|||||TWO_SIDED|95.0|0.67|1.0||||||full platelet recovery||1.00|0.67|
72619665|NCT01546987|144770199|SUPERIORITY||Hazard Ratio (HR)|1.01||||0.99|TWO_SIDED|95.0|0.33|3.13|||Log Rank|||||3.13|0.33|0.99
72450536|NCT02938923|144421059|SUPERIORITY||Mean Difference (Final Values)|0.83||||0.009|TWO_SIDED|95.0|0.21|1.44||Unadjusted p-value|Mixed Models Analysis|t (df, 214) = 2.65|Difference between the changes (EX+T - EX+P)|Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with an Autoregressive (1) covariance structure in the model with covariates.||1.44|0.21|0.009
72469958|NCT00940875|144463862|SUPERIORITY_OR_OTHER||Hazard Ratio, log|1.3||||0.4805|TWO_SIDED|95.0|0.63|2.68|||Wald Test||The hazard ratio was estimated using the Cox regression model and stratified by Eastern Cooperative Oncology Group (ECOG) Performance Status (PS), disease stage, histology, and smoking status.|||2.68|0.63|0.4805
72469959|NCT00940875|144463863|SUPERIORITY_OR_OTHER||Difference in Response Rates|-11.54|||||TWO_SIDED|95.0|-40.3|17.2|||||The 95% CI for difference of 2 rates was determined using the Hauck-Anderson method.|Week 8||17.2|-40.3|
72469960|NCT00940875|144463863|SUPERIORITY_OR_OTHER||Difference in Response Rates|-13.46|||||TWO_SIDED|95.0|-36.0|9.0|||||The 95% CI for difference of 2 rates was determined using the Hauck-Anderson method.|Week 16||9.0|-36.0|
72469961|NCT00940875|144463865|SUPERIORITY_OR_OTHER|||||||0.5393|TWO_SIDED||||||Log Rank|||Difference between treatment groups in OS||||0.5393
72619666|NCT01546987|144770200|SUPERIORITY||Hazard Ratio (HR)|0.71||||0.48|TWO_SIDED|95.0|0.29|1.75||Two-sided significance level = 0.05|Log Rank||Reference level = ADT + RT arm|Revised protocol due to early accrual closure (September 2014) computes that 5-year survival of 78% and annual hazard rate of 0.02 for ADT + RT arm, with five years of additional follow-up after early accrual closure provides 32% power (at two-sided alpha = 0.05) to detect a 50% reduction in failure rate.||1.75|0.29|0.48
72619667|NCT01546987|144770201|SUPERIORITY||Hazard Ratio (HR)|0.86||||0.65|TWO_SIDED|95.0|0.45|1.63||Two-sided significance level = 0.05|Log Rank||Reference level = ADT + RT|||1.63|0.45|0.65
72619668|NCT01546987|144770203|SUPERIORITY|||||||0.76|||||||t-test, 2 sided|||One hundred thirty evaluable participants (arms combined), provides 81% power to detect a moderate effect size of 0.5 using a two-sample test of the difference in means with a two-sided type I error of 0.05.||||0.76
72619669|NCT01546987|144770204|SUPERIORITY|||||||0.44|||||||t-test, 2 sided|||\[Bowel domain\] One hundred thirty evaluable participants (arms combined), provides 81% power to detect a moderate effect size of 0.5 using a two-sample test of the difference in means with a two-sided type I error of 0.05.||||0.44
72391072|NCT03000439|144289743|OTHER||Difference in percentage|-7.6|||||TWO_SIDED|95.0|-29.66|14.45|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR90 at DB Week 20||14.45|-29.66|
72391073|NCT03000439|144289743|OTHER||Difference in percentage|-13.71|||||TWO_SIDED|95.0|-37.19|9.77|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR90 at DB Week 12||9.77|-37.19|
72391074|NCT03000439|144289743|OTHER||Difference in percentage|-4.03|||||TWO_SIDED|95.0|-26.67|18.61|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR90 at DB Week 16||18.61|-26.67|
72391075|NCT03000439|144289743|OTHER||Difference in percentage|-14.75|||||TWO_SIDED|95.0|-35.32|5.83|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR90 at DB Week 32||5.83|-35.32|
72391076|NCT03000439|144289743|OTHER||Difference in percentage|-4.38|||||TWO_SIDED|95.0|-26.02|17.26|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR90 at DB Week 24||17.26|-26.02|
72391077|NCT03000439|144289743|OTHER||Difference in percentage|-7.95|||||TWO_SIDED|95.0|-28.89|12.99|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR90 at DB Week 28||12.99|-28.89|
72391078|NCT03000439|144289743|OTHER||Difference in percentage|-6.91|||||TWO_SIDED|95.0|-30.65|16.83|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR90 at DB Week 36||16.83|-30.65|
72391079|NCT03000439|144289743|OTHER||Difference in percentage|-3.69|||||TWO_SIDED|95.0|-27.16|19.78|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR90 at DB Week 40||19.78|-27.16|
72391080|NCT03000439|144289743|OTHER||Difference in percentage|-0.46|||||TWO_SIDED|95.0|-23.6|22.68|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR90 at DB Week 44||22.68|-23.60|
72391081|NCT03000439|144289743|OTHER||Difference in percentage|-0.46|||||TWO_SIDED|95.0|-23.6|22.68|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR90 at DB Week 48||22.68|-23.60|
72391082|NCT03000439|144289743|OTHER||Difference in percentage|-0.46|||||TWO_SIDED|95.0|-23.6|22.68|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR90 at DB Week 52||22.68|-23.60|
72391083|NCT03000439|144289743|OTHER||Difference in percentage|-21.2|||||TWO_SIDED|95.0|-42.45|0.05|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR100 at DB Week 4||0.05|-42.45|
72391084|NCT03000439|144289743|OTHER||Difference in percentage|-18.32|||||TWO_SIDED|95.0|-37.98|1.34|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR100 at DB Week 8||1.34|-37.98|
72391085|NCT03000439|144289743|OTHER||Difference in percentage|-11.52|||||TWO_SIDED|95.0|-31.65|8.61|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR100 at DB Week 12||8.61|-31.65|
72391086|NCT03000439|144289743|OTHER||Difference in percentage|-7.95|||||TWO_SIDED|95.0|-28.89|12.99|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR100 at DB Week 16||12.99|-28.89|
72391087|NCT03000439|144289743|OTHER||Difference in percentage|1.38|||||TWO_SIDED|95.0|-16.15|18.91|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR100 at DB Week 20||18.91|-16.15|
72391088|NCT03000439|144289743|OTHER||Difference in percentage|-1.5|||||TWO_SIDED|95.0|-21.36|18.37|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR100 at DB Week 24||18.37|-21.36|
72450537|NCT02938923|144421059|SUPERIORITY||Mean Difference (Final Values)|0.13||||0.778|TWO_SIDED|95.0|-0.76|1.02||Unadjusted p-value|Mixed Models Analysis|t (df, 214) = 0.28|Difference between the changes (EX+T - EUC)|Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with an Autoregressive (1) covariance structure in the model with covariates.||1.02|-0.76|0.778
72450538|NCT02938923|144421059|SUPERIORITY||Mean Difference (Final Values)|-0.7||||0.124|TWO_SIDED|95.0|-1.59|0.19||Unadjusted p-value|Mixed Models Analysis|t (df, 214) = -1.55|Difference between the changes (EX+P - EUC)|Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with an Autoregressive (1) covariance structure in the model with covariates.||0.19|-1.59|0.124
72450539|NCT02938923|144421059|SUPERIORITY||Mean Difference (Final Values)|0.69||||0.027|TWO_SIDED|95.0|0.08|1.31||Unadjusted p-value|Mixed Models Analysis|t (df, 112) = 2.24|Difference between the changes (EX+T - EX+P)|Comparison based on contrasts between two groups at baseline to three months from mixed model ANOVA with an unstructured covariance structure.||1.31|0.08|0.027
72450540|NCT02938923|144421059|SUPERIORITY||Mean Difference (Final Values)|-0.09||||0.833|TWO_SIDED|95.0|-0.97|0.78||Unadjusted p-value|Mixed Models Analysis|t (df, 112) = -0.21|Difference between the changes (EX+T - EUC)|Comparison based on contrasts between two groups at baseline to three months from mixed model ANOVA with an unstructured covariance structure.||0.78|-0.97|0.833
72450541|NCT02938923|144421059|SUPERIORITY||Mean Difference (Final Values)|-0.79||||0.08|TWO_SIDED|95.0|-1.67|0.1||Unadjusted p-value|Mixed Models Analysis|t (df, 112) = -1.77|Difference between the changes (EX+P - EUC)|Comparison based on contrasts between two groups at baseline to three months from mixed model ANOVA with an unstructured covariance structure.||0.10|-1.67|0.080
72450542|NCT02938923|144421059|SUPERIORITY||Mean Difference (Final Values)|0.67||||0.014|TWO_SIDED|95.0|0.14|1.21||Unadjusted p-value|Mixed Models Analysis|t (df, 214) = 2.49|Difference between the changes (EX+T - EX+P)|Comparison based on contrasts between two groups at baseline to three months from mixed model ANOVA with an Autoregressive (1) covariance structure in the model with covariates.||1.21|0.14|0.014
72561902|NCT03259789|144654655|SUPERIORITY||Odds Ratio (OR)|2.57||||0.003|TWO_SIDED|95.0|1.31|5.04||P-value is presented based on one-sided statistical tests using a 0.025 level of significance|Mixed-effects repeated measures|Mixed-effects repeated measures analysis includes country, treatment, visit, treatment and baseline HbA1c value as fixed effect covariates|The odds ratios of bexagliflozin group over the placebo group at each visit will be estimated from LS means based on the model with the corresponding p-values and their two-sided 95% CIs presented.|Odds ratio at Week 18 was calculated as the odds ratio of bexagliflozin group over placebo group.||5.04|1.31|0.0030
72561903|NCT03259789|144654655|SUPERIORITY||Odds Ratio (OR)|3.88|||<|0.0001|TWO_SIDED|95.0|1.99|7.58||P-value is presented based on one-sided statistical tests using a 0.025 level of significance|Mixed-effects repeated measures|Mixed-effects repeated measures analysis includes country, treatment, visit, treatment and baseline HbA1c value as fixed effect covariates|The odds ratios of bexagliflozin group over the placebo group at each visit will be estimated from LS means based on the model with the corresponding p-values and their two-sided 95% CIs presented.|Odds ratio at Week 24 was calculated as the odds ratio of bexagliflozin group over placebo group.||7.58|1.99|< 0.0001
72561904|NCT03259789|144654657|SUPERIORITY||Difference of LS Means|-2.51|||<|0.0001|TWO_SIDED|95.0|-3.45|-1.57|||ANCOVA|ANCOVA analysis includes country, treatment, visit, treatment and baseline HbA1c value as fixed effect covariates||||-1.57|-3.45|< 0.0001
72561905|NCT03259789|144654659|SUPERIORITY||Difference of LS Means|-0.56|||<|0.0001|TWO_SIDED|95.0|-0.74|-0.38||P-value is presented based on one-sided statistical tests using a 0.025 level of significance|Mixed-effects repeated measures|Mixed-effects repeated measures analysis includes country, treatment, visit, treatment and baseline HbA1c value as fixed effect covariates||Model-adjusted change from baseline at week 6 was calculated as the difference in LS Mean between bexagliflozin group and placebo group.||-0.38|-0.74|< 0.0001
72619670|NCT01546987|144770204|SUPERIORITY|||||||0.13|||||||t-test, 2 sided|||\[Urinary domain\] One hundred thirty evaluable participants (arms combined), provides 81% power to detect a moderate effect size of 0.5 using a two-sample test of the difference in means with a two-sided type I error of 0.05.||||0.13
72619671|NCT01546987|144770204|SUPERIORITY|||||||0.5|||||||t-test, 2 sided|||\[Sexual domain\] One hundred thirty evaluable participants (arms combined), provides 81% power to detect a moderate effect size of 0.5 using a two-sample test of the difference in means with a two-sided type I error of 0.05.||||0.50
72450543|NCT02938923|144421059|SUPERIORITY||Mean Difference (Final Values)|-0.08||||0.834|TWO_SIDED|95.0|-0.84|0.68||Unadjusted p-value|Mixed Models Analysis|t (df, 214) = -0.21|Difference between the changes (EX+T - EUC)|Comparison based on contrasts between two groups at baseline to three months from mixed model ANOVA with an Autoregressive (1) covariance structure in the model with covariates.||0.68|-0.84|0.834
72450544|NCT02938923|144421059|SUPERIORITY||Mean Difference (Final Values)|-0.75||||0.054|TWO_SIDED|95.0|-1.52|0.01||Unadjusted p-value|Mixed Models Analysis|t (df, 214) = -1.94|Difference between the changes (EX+P - EUC)|Comparison based on contrasts between two groups at baseline to three months from mixed model ANOVA with an Autoregressive (1) covariance structure in the model with covariates.||0.01|-1.52|0.054
72561906|NCT03259789|144654659|SUPERIORITY||Difference of LS Means|-0.66|||<|0.0001|TWO_SIDED|95.0|-0.86|-0.46||P-value is presented based on one-sided statistical tests using a 0.025 level of significance|Mixed-effects repeated measures|Mixed-effects repeated measures analysis includes country, treatment, visit, treatment and baseline HbA1c value as fixed effect covariates||Model-adjusted change from baseline at week 12 was calculated as the difference in LS Mean between bexagliflozin group and placebo group.||-0.46|-0.86|< 0.0001
72561907|NCT03259789|144654659|SUPERIORITY||Difference of LS Means|-0.5|||<|0.0001|TWO_SIDED|95.0|-0.69|-0.3||P-value is presented based on one-sided statistical tests using a 0.025 level of significance|Mixed-effects repeated measures|Mixed-effects repeated measures analysis includes country, treatment, visit, treatment and baseline HbA1c value as fixed effect covariates||Model-adjusted change from baseline at week 18 was calculated as the difference in LS Mean between bexagliflozin group and placebo group.||-0.30|-0.69|< 0.0001
72619672|NCT01546987|144770204|SUPERIORITY|||||||0.96|||||||t-test, 2 sided|||\[Hormonal domain\] One hundred thirty evaluable participants (arms combined), provides 81% power to detect a moderate effect size of 0.5 using a two-sample test of the difference in means with a two-sided type I error of 0.05.||||0.96
72619673|NCT01546987|144770215|SUPERIORITY||Hazard Ratio (HR)|0.51||||0.0104|TWO_SIDED|95.0|0.29|0.89|||Log Rank||Reference arm = ADT + RT arm|||0.89|0.29|0.0104
72391089|NCT03000439|144289743|OTHER||Difference in percentage|-8.29|||||TWO_SIDED|95.0|-27.91|11.32|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR100 at DB Week 28||11.32|-27.91|
72391090|NCT03000439|144289743|OTHER||Difference in percentage|-15.09|||||TWO_SIDED|95.0|-34.29|4.1|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR100 at DB Week 32||4.10|-34.29|
72391091|NCT03000439|144289743|OTHER||Difference in percentage|-11.52|||||TWO_SIDED|95.0|-31.65|8.61|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR100 at DB Week 36||8.61|-31.65|
72391092|NCT03000439|144289743|OTHER||Difference in percentage|-7.6|||||TWO_SIDED|95.0|-29.66|14.45|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR100 at DB Week 40||14.45|-29.66|
72391093|NCT03000439|144289743|OTHER||Difference in percentage|-4.38|||||TWO_SIDED|95.0|-26.02|17.26|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR100 at DB Week 44||17.26|-26.02|
72391094|NCT03000439|144289743|OTHER||Difference in percentage|-0.81|||||TWO_SIDED|95.0|-23.04|21.43|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR100 at DB Week 48||21.43|-23.04|
72391095|NCT03000439|144289743|OTHER||Difference in percentage|-0.81|||||TWO_SIDED|95.0|-23.04|21.43|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR100 at DB Week 52||21.43|-23.04|
72391096|NCT03000439|144289751|OTHER||Difference in percentage|-7.83|||||TWO_SIDED|95.0|-23.42|7.75|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 4||7.75|-23.42|
72391097|NCT03000439|144289751|OTHER||Difference in percentage|5.07|||||TWO_SIDED|95.0|-13.94|24.08|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 8||24.08|-13.94|
72391098|NCT03000439|144289751|OTHER||Difference in percentage|0.81|||||TWO_SIDED|95.0|-21.43|23.04|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 12||23.04|-21.43|
72391099|NCT03000439|144289751|OTHER||Difference in percentage|10.14|||||TWO_SIDED|95.0|-13.82|34.1|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 16||34.10|-13.82|
72391100|NCT03000439|144289751|OTHER||Difference in percentage|16.24|||||TWO_SIDED|95.0|-8.43|40.92|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 20||40.92|-8.43|
72391101|NCT03000439|144289751|OTHER||Difference in percentage|9.45|||||TWO_SIDED|95.0|-15.49|34.39|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 24||34.39|-15.49|
72450545|NCT02938923|144421060|SUPERIORITY||Mean Difference (Final Values)|0.25||||0.326|TWO_SIDED|95.0|-0.25|0.74||Unadjusted p-value|Mixed Models Analysis|t (df, 112) = 0.99|Difference between the BADL changes (EX+T - EX+P)|Comparison of the Basic Activities of Daily Living (BADL) subscale based on contrasts between two groups at baseline to six months from mixed model ANOVA with an unstructured covariance structure.||0.74|-0.25|0.326
72450546|NCT02938923|144421060|SUPERIORITY||Mean Difference (Final Values)|-0.19||||0.587|TWO_SIDED|95.0|-0.87|0.49||Unadjusted p-value|Mixed Models Analysis|t (df, 112) = -0.54|Difference between the BADL changes (EX+T - EUC)|Comparison of the Basic Activities of Daily Living (BADL) subscale based on contrasts between two groups at baseline to six months from mixed model ANOVA with an unstructured covariance structure.||0.49|-0.87|0.587
72391102|NCT03000439|144289751|OTHER||Difference in percentage|9.1|||||TWO_SIDED|95.0|-16.13|34.33|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 28||34.33|-16.13|
72391103|NCT03000439|144289751|OTHER||Difference in percentage|9.1|||||TWO_SIDED|95.0|-16.13|34.33|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 32||34.33|-16.13|
72391104|NCT03000439|144289751|OTHER||Difference in percentage|9.1|||||TWO_SIDED|95.0|-16.13|34.33|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 36||34.33|-16.13|
72391105|NCT03000439|144289751|OTHER||Difference in percentage|9.1|||||TWO_SIDED|95.0|-16.13|34.33|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 40||34.33|-16.13|
72391106|NCT03000439|144289751|OTHER||Difference in percentage|9.1|||||TWO_SIDED|95.0|-16.13|34.33|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 44||34.33|-16.13|
72391107|NCT03000439|144289751|OTHER||Difference in percentage|12.33|||||TWO_SIDED|95.0|-12.91|37.56|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 48||37.56|-12.91|
72391108|NCT03000439|144289751|OTHER||Difference in percentage|12.33|||||TWO_SIDED|95.0|-12.91|37.56|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 52||37.56|-12.91|
72391109|NCT03000439|144289757|OTHER||Difference in LS Mean|-0.01|||||TWO_SIDED|95.0|-2.4|2.38||||||DB Week 4: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||2.38|-2.40|
72391110|NCT03000439|144289757|OTHER||Difference in LS Mean|0.94|||||TWO_SIDED|95.0|-2.25|4.12||||||DB Week 8: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||4.12|-2.25|
72391111|NCT03000439|144289757|OTHER||Difference in LS Mean|-0.24|||||TWO_SIDED|95.0|-4.54|4.06||||||DB Week 12: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||4.06|-4.54|
72469962|NCT00940875|144463865|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.79||||0.5399|TWO_SIDED|95.0|0.38|1.66|||Wald Test||The hazard ratio was estimated using the Cox regression model and stratified by ECOG PS, disease stage, histology, and smoking status.|||1.66|0.38|0.5399
72450547|NCT02938923|144421060|SUPERIORITY||Mean Difference (Final Values)|-0.43||||0.213|TWO_SIDED|95.0|-1.12|0.25||Unadjusted p-value|Mixed Models Analysis|t (df, 112) = -1.25|Difference between the BADL changes (EX+P - EUC)|Comparison of the Basic Activities of Daily Living (BADL) subscale based on contrasts between two groups at baseline to six months from mixed model ANOVA with an unstructured covariance structure.||0.25|-1.12|0.213
72450548|NCT02938923|144421060|SUPERIORITY||Mean Difference (Final Values)|0.23||||0.41|TWO_SIDED|95.0|-0.32|0.78||Unadjusted p-value|Mixed Models Analysis|t (df, 233) = 0.83|Difference between the BADL changes (EX+T - EX+P)|Comparison of the Basic Activities of Daily Living (BADL) subscale based on contrasts between two groups at baseline to six months from mixed model ANOVA with a Toeplitz covariance structure in the model with covariates.||0.78|-0.32|0.410
72450549|NCT02938923|144421060|SUPERIORITY||Mean Difference (Final Values)|-0.24||||0.527|TWO_SIDED|95.0|-0.99|0.51||Unadjusted p-value|Mixed Models Analysis|t (df, 233) = -0.63|Difference between the BADL changes (EX+T - EUC)|Comparison of the Basic Activities of Daily Living (BADL) subscale based on contrasts between two groups at baseline to six months from mixed model ANOVA with a Toeplitz covariance structure in the model with covariates.||0.51|-0.99|0.527
72450550|NCT02938923|144421060|SUPERIORITY||Mean Difference (Final Values)|-0.47||||0.219|TWO_SIDED|95.0|-1.23|0.28||Unadjusted p-value|Mixed Models Analysis|t (df, 233) = -1.23|Difference between the BADL changes (EX+P - EUC)|Comparison of the Basic Activities of Daily Living (BADL) subscale based on contrasts between two groups at baseline to six months from mixed model ANOVA with a Toeplitz covariance structure in the model with covariates.||0.28|-1.23|0.219
72450551|NCT02938923|144421060|SUPERIORITY||Mean Difference (Final Values)|0.22||||0.355|TWO_SIDED|95.0|-0.25|0.69||Unadjusted p-value|Mixed Models Analysis|t (df, 112) = 0.93|Difference between the BADL changes (EX+T - EX+P)|Comparison of the Basic Activities of Daily Living (BADL) subscale based on contrasts between two groups at baseline to three months from mixed model ANOVA with an unstructured covariance structure.||0.69|-0.25|0.355
72450552|NCT02938923|144421060|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.554|TWO_SIDED|95.0|-0.88|0.47||Unadjusted p-value|Mixed Models Analysis|t (df, 112) = -0.59|Difference between the BADL changes (EX+T - EUC)|Comparison of the Basic Activities of Daily Living (BADL) subscale based on contrasts between two groups at baseline to three months from mixed model ANOVA with an unstructured covariance structure.||0.47|-0.88|0.554
72450553|NCT02938923|144421060|SUPERIORITY||Mean Difference (Final Values)|-0.42||||0.219|TWO_SIDED|95.0|-1.1|0.26||Unadjusted p-value|Mixed Models Analysis|t (df, 112) = -1.24|Difference between the BADL changes (EX+P - EUC)|Comparison of the Basic Activities of Daily Living (BADL) subscale based on contrasts between two groups at baseline to three months from mixed model ANOVA with an unstructured covariance structure.||0.26|-1.10|0.219
72450554|NCT02938923|144421060|SUPERIORITY||Mean Difference (Final Values)|0.22||||0.345|TWO_SIDED|95.0|-0.24|0.68||Unadjusted p-value|Mixed Models Analysis|t (df, 233) = 0.95|Difference between the BADL changes (EX+T - EX+P)|Comparison of the Basic Activities of Daily Living (BADL) subscale based on contrasts between two groups at baseline to three months from mixed model ANOVA with a Toeplitz covariance structure in the model with covariates.||0.68|-0.24|0.345
72498954|NCT00348140|144528170|SUPERIORITY||Mean Difference (Net)|0.0||||0.938|TWO_SIDED|95.0|-0.2|0.2|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|For Week 12||0.2|-0.2|0.938
72450555|NCT02938923|144421060|SUPERIORITY||Mean Difference (Final Values)|-0.23||||0.494|TWO_SIDED|95.0|-0.88|0.43||Unadjusted p-value|Mixed Models Analysis|t (df, 233) = -0.69|Difference between the BADL changes (EX+T - EUC)|Comparison of the Basic Activities of Daily Living (BADL) subscale based on contrasts between two groups at baseline to three months from mixed model ANOVA with a Toeplitz covariance structure in the model with covariates.||0.43|-0.88|0.494
72450556|NCT02938923|144421060|SUPERIORITY||Mean Difference (Final Values)|-0.45||||0.18|TWO_SIDED|95.0|-1.11|0.21||Unadjusted p-value|Mixed Models Analysis|t (df, 233) = -1.35|Difference between the BADL changes (EX+P - EUC)|Comparison of the Basic Activities of Daily Living (BADL) subscale based on contrasts between two groups at baseline to three months from mixed model ANOVA with a Toeplitz covariance structure in the model with covariates.||0.21|-1.11|0.180
72450557|NCT02938923|144421060|SUPERIORITY||Mean Difference (Final Values)|-0.12||||0.693|TWO_SIDED|95.0|-0.75|0.5||Unadjusted p-value|Mixed Models Analysis|t (df, 112) = -0.4|Difference between the changes of IADL of EX+T - EX+P|Comparison of the Instrumental Activities of Daily Living (IADL) subscale based on contrasts between two groups at baseline to six months from mixed model ANOVA with an unstructured covariance structure.||0.50|-0.75|0.693
72450558|NCT02938923|144421060|SUPERIORITY||Mean Difference (Final Values)|-0.42||||0.327|TWO_SIDED|95.0|-1.27|0.43||Unadjusted p-value|Mixed Models Analysis|t (df, 112) = -0.98|Difference between the IADL changes (EX+T - EUC)|Comparison of the Instrumental Activities of Daily Living (IADL) subscale based on contrasts between two groups at baseline to six months from mixed model ANOVA with an unstructured covariance structure.||0.43|-1.27|0.327
72450559|NCT02938923|144421060|SUPERIORITY||Mean Difference (Final Values)|-0.3||||0.493|TWO_SIDED|95.0|-1.15|0.56||Unadjusted p-value|Mixed Models Analysis|t (df, 112) = -0.69|Difference between the IADL changes (EX+P - EUC)|Comparison of the Instrumental Activities of Daily Living (IADL) subscale based on contrasts between two groups at baseline to six months from mixed model ANOVA with an unstructured covariance structure.||0.56|-1.15|0.493
72450560|NCT02938923|144421060|SUPERIORITY||Mean Difference (Final Values)|-0.12||||0.698|TWO_SIDED|95.0|-0.72|0.49||Unadjusted p-value|Mixed Models Analysis|t (df, 233) = -0.39|Difference between the IADL changes (EX+T - EX+P)|Comparison of the Instrumental Activities of Daily Living (IADL) subscale based on contrasts between two groups at baseline to six months from mixed model ANOVA with an Autoregressive (1) covariance structure in the model with covariates.||0.49|-0.72|0.698
72450561|NCT02938923|144421060|SUPERIORITY||Mean Difference (Final Values)|-0.35||||0.404|TWO_SIDED|95.0|-1.17|0.47||Unadjusted p-value|Mixed Models Analysis|t (df, 233) = -0.84|Difference between the IADL changes (EX+T - EUC)|Comparison of the Instrumental Activities of Daily Living (IADL) subscale based on contrasts between two groups at baseline to six months from mixed model ANOVA with an Autoregressive (1) covariance structure in the model with covariates.||0.47|-1.17|0.404
72619674|NCT05287685|144770228|OTHER|||||||0.29|||||||t-test, 2 sided|||Preliminary pre-post outcome analysis for the open trial (n = 7). The analysis was a paired samples t-test comparing baseline (week 0) to posttest (week 8) scores.||||.29
72450562|NCT02938923|144421060|SUPERIORITY||Mean Difference (Final Values)|-0.23||||0.585|TWO_SIDED|95.0|-1.06|0.6||Unadjusted p-value|Mixed Models Analysis|t (df, 233) = -0.55|Difference between the IADL changes (EX+P - EUC)|Comparison of the Instrumental Activities of Daily Living (IADL) subscale based on contrasts between two groups at baseline to six months from mixed model ANOVA with an Autoregressive (1) covariance structure in the model with covariates.||0.60|-1.06|0.585
72450563|NCT02938923|144421060|SUPERIORITY||Mean Difference (Final Values)|0.23||||0.399|TWO_SIDED|95.0|-0.31|0.76||Unadjusted p-value|Mixed Models Analysis|t (df, 112) = 0.85|Difference between IADL changes (EX+T - EX+P)|Comparison of the Instrumental Activities of Daily Living (IADL) subscale based on contrasts between two groups at baseline to three months from mixed model ANOVA with an unstructured covariance structure.||0.76|-0.31|0.399
72450564|NCT02938923|144421060|SUPERIORITY||Mean Difference (Final Values)|0.23||||0.554|TWO_SIDED|95.0|-0.53|0.98||Unadjusted p-value|Mixed Models Analysis|t (df, 112) = 0.59|Difference between the IADL changes (EX+T - EUC)|Comparison of the Instrumental Activities of Daily Living (IADL) subscale based on contrasts between two groups at baseline to three months from mixed model ANOVA with an unstructured covariance structure.||0.98|-0.53|0.554
72450565|NCT02938923|144421060|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.998|TWO_SIDED|95.0|-0.76|0.76||Unadjusted p-value|Mixed Models Analysis|t (df, 112) = 0|Difference between the IADL changes (EX+P - EUC)|Comparison of the Instrumental Activities of Daily Living (IADL) subscale based on contrasts between two groups at baseline to three months from mixed model ANOVA with an unstructured covariance structure.||0.76|-0.76|0.998
72450566|NCT02938923|144421060|SUPERIORITY||Mean Difference (Final Values)|0.23||||0.378|TWO_SIDED|95.0|-0.28|0.73||Unadjusted p-value|Mixed Models Analysis|t (df, 233) = 0.88|Difference between the IADL changes (EX+T - EX+P)|Comparison of the Instrumental Activities of Daily Living (IADL) subscale based on contrasts between two groups at baseline to three months from mixed model ANOVA with an Autoregressive (1) covariance structure in the model with covariates.||0.73|-0.28|0.378
72450567|NCT02938923|144421060|SUPERIORITY||Mean Difference (Final Values)|0.19||||0.608|TWO_SIDED|95.0|-0.53|0.91||Unadjusted p-value|Mixed Models Analysis|t (df, 233) = 0.51|Difference between the IADL changes (EX+T - EUC)|Comparison of the Instrumental Activities of Daily Living (IADL) subscale based on contrasts between two groups at baseline to three months from mixed model ANOVA with an Autoregressive (1) covariance structure in the model with covariates.||0.91|-0.53|0.608
72450568|NCT02938923|144421060|SUPERIORITY||Mean Difference (Final Values)|-0.04||||0.915|TWO_SIDED|95.0|-0.76|0.69||Unadjusted p-value|Mixed Models Analysis|t (df, 233) = -0.11|Difference between the IADL changes (EX+P - EUC)|Comparison of the Instrumental Activities of Daily Living (IADL) subscale based on contrasts between two groups at baseline to three months from mixed model ANOVA with an Autoregressive (1) covariance structure in the model with covariates.||0.69|-0.76|0.915
72619675|NCT05287685|144770228|OTHER|||||||0.34|||||||t-test, 2 sided|||Preliminary outcome analysis for the open trial (n = 7). The analysis was a paired samples t-test comparing baseline(week 0) to follow-up (week 16) scores.||||.34
72391112|NCT03000439|144289757|OTHER||Difference in LS Mean|-0.86|||||TWO_SIDED|95.0|-3.99|2.28||||||DB Week 16: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||2.28|-3.99|
72391113|NCT03000439|144289757|OTHER||Difference in LS Mean|-1.09|||||TWO_SIDED|95.0|-3.12|0.94||||||DB Week 20: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||0.94|-3.12|
72391114|NCT03000439|144289757|OTHER||Difference in LS Mean|0.3|||||TWO_SIDED|95.0|-1.46|2.06||||||DB Week 24: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||2.06|-1.46|
72391115|NCT03000439|144289757|OTHER||Difference in LS Mean|-1.28|||||TWO_SIDED|95.0|-7.85|5.29||||||DB Week 28: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||5.29|-7.85|
72391116|NCT03000439|144289757|OTHER||Difference in LS Mean|0.48|||||TWO_SIDED|95.0|-1.98|2.93||||||DB Week 32: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||2.93|-1.98|
72391117|NCT03000439|144289757|OTHER||Difference in LS Mean|-0.26|||||TWO_SIDED|95.0|-1.86|1.35||||||DB Week 36: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||1.35|-1.86|
72391118|NCT03000439|144289757|OTHER||Difference in LS Mean|0.73|||||TWO_SIDED|95.0|-2.18|3.63||||||DB Week 40: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||3.63|-2.18|
72391119|NCT03000439|144289757|OTHER||Difference in LS Mean|-0.83|||||TWO_SIDED|95.0|-3.22|1.56||||||DB Week 44: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||1.56|-3.22|
72391120|NCT03000439|144289757|OTHER||Difference in LS Mean|-0.23|||||TWO_SIDED|95.0|-1.76|1.3||||||DB Week 48: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||1.30|-1.76|
72391121|NCT03000439|144289757|OTHER||Difference in LS Mean|-0.75|||||TWO_SIDED|95.0|-3.43|1.93||||||DB Week 52: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||1.93|-3.43|
72391122|NCT03000439|144289758|OTHER||Difference in LS Mean|0.9|||||TWO_SIDED|95.0|-1.8|3.61||||||DB Week 4: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||3.61|-1.80|
72391123|NCT03000439|144289758|OTHER||Difference in LS Mean|2.11|||||TWO_SIDED|95.0|-0.64|4.86||||||DB Week 8: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||4.86|-0.64|
72450569|NCT02938923|144421061|SUPERIORITY||Mean Difference (Final Values)|0.49||||0.602|TWO_SIDED|95.0|-1.36|2.33||Unadjusted p-value|Mixed Models Analysis|t (df, 234) = 0.52|Difference between the changes (EX+T - EX+P)|Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with a Toeplitz covariance structure.||2.33|-1.36|0.602
72450570|NCT02938923|144421061|SUPERIORITY||Mean Difference (Final Values)|-0.96||||0.454|TWO_SIDED|95.0|-3.48|1.56||Unadjusted p-value|Mixed Models Analysis|t (df, 234) = -0.75|Difference between the changes (EX+T - EUC)|Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with a Toeplitz covariance structure.||1.56|-3.48|0.454
72450571|NCT02938923|144421061|SUPERIORITY||Mean Difference (Final Values)|-1.45||||0.262|TWO_SIDED|95.0|-3.98|1.09||Unadjusted p-value|Mixed Models Analysis|t (df, 234) = -1.13|Difference between the changes (EX+P - EUC)|Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with a Toeplitz covariance structure.||1.09|-3.98|0.262
72450572|NCT02938923|144421061|SUPERIORITY||Mean Difference (Final Values)|0.46||||0.639|TWO_SIDED|95.0|-1.47|2.4||Unadjusted p-value|Mixed Models Analysis|t (df, 234) = 0.47|Difference between the changes (EX+T - EX+P)|Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with a Toeplitz covariance structure in the model with covariates.||2.40|-1.47|0.639
72450573|NCT02938923|144421061|SUPERIORITY||Mean Difference (Final Values)|-1.04||||0.438|TWO_SIDED|95.0|-3.66|1.59||Unadjusted p-value|Mixed Models Analysis|t (df, 234) = -0.78|Difference between the changes (EX+T - EUC)|Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with a Toeplitz covariance structure in the model with covariates.||1.59|-3.66|0.438
72450574|NCT02938923|144421061|SUPERIORITY||Mean Difference (Final Values)|-1.5||||0.265|TWO_SIDED|95.0|-4.14|1.14||Unadjusted p-value|Mixed Models Analysis|t (df, 234) = -1.12|Difference between the changes (EX+P - EUC)|Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with a Toeplitz covariance structure in the model with covariates.||1.14|-4.14|0.265
72450575|NCT02938923|144421061|SUPERIORITY||Mean Difference (Final Values)|0.48||||0.555|TWO_SIDED|95.0|-1.11|2.07||Unadjusted p-value|Mixed Models Analysis|t (df, 234) = 0.59|Difference between the changes (EX+T - EX+P)|Comparison based on contrasts between two groups at baseline to three months from mixed model ANOVA with a Toeplitz covariance structure.||2.07|-1.11|0.555
72450576|NCT02938923|144421061|SUPERIORITY||Mean Difference (Final Values)|-0.12||||0.917|TWO_SIDED|95.0|-2.39|2.15||Unadjusted p-value|Mixed Models Analysis|t (df, 234) = -0.10|Difference between the changes (EX+T - EUC)|Comparison based on contrasts between two groups at baseline to three months from mixed model ANOVA with a Toeplitz covariance structure.||2.15|-2.39|0.917
72498955|NCT00348140|144528170|SUPERIORITY||Mean Difference (Net)|0.0||||0.887|TWO_SIDED|95.0|-0.2|0.2|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|For Week 12||0.2|-0.2|0.887
72450577|NCT02938923|144421061|SUPERIORITY||Mean Difference (Final Values)|-0.6||||0.606|TWO_SIDED|95.0|-2.87|1.68||Unadjusted p-value|Mixed Models Analysis|t (df, 234) = -0.52|Difference between the changes (EX+P - EUC)|Comparison based on contrasts between two groups at baseline to three months from mixed model ANOVA with a Toeplitz covariance structure.||1.68|-2.87|0.606
72450578|NCT02938923|144421061|SUPERIORITY||Mean Difference (Final Values)|0.48||||0.549|TWO_SIDED|95.0|-1.09|2.04||Unadjusted p-value|Mixed Models Analysis|t (df, 234) = 0.60|Difference between the changes (EX+T - EX+P)|Comparison based on contrasts between two groups at baseline to three months from mixed model ANOVA with a Toeplitz covariance structure in the model with covariates.||2.04|-1.09|0.549
72498956|NCT00348140|144528170|SUPERIORITY||Mean Difference (Net)|-0.1||||0.465|TWO_SIDED|95.0|-0.4|0.2|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|For Week 24||0.2|-0.4|0.465
72391124|NCT03000439|144289758|OTHER||Difference in LS Mean|-0.02|||||TWO_SIDED|95.0|-4.25|4.21||||||DB Week 12: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||4.21|-4.25|
72391125|NCT03000439|144289758|OTHER||Difference in LS Mean|-1.12|||||TWO_SIDED|95.0|-4.32|2.09||||||DB Week 16: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||2.09|-4.32|
72450579|NCT02938923|144421061|SUPERIORITY||Mean Difference (Final Values)|-0.16||||0.887|TWO_SIDED|95.0|-2.38|2.06||Unadjusted p-value|Mixed Models Analysis|t (df, 234) = -0.14|Difference between the changes (EX+T - EUC)|Comparison based on contrasts between two groups at baseline to three months from mixed model ANOVA with a Toeplitz covariance structure in the model with covariates.||2.06|-2.38|0.887
72450580|NCT02938923|144421061|SUPERIORITY||Mean Difference (Final Values)|-0.64||||0.574|TWO_SIDED|95.0|-2.87|1.59||Unadjusted p-value|Mixed Models Analysis|t (df, 234) = -0.56|Difference between the changes (EX+P - EUC)|Comparison based on contrasts between two groups at baseline to three months from mixed model ANOVA with a Toeplitz covariance structure in the model with covariates.||1.59|-2.87|0.574
72450581|NCT02938923|144421062|SUPERIORITY||Mean Difference (Final Values)|0.96||||0.649|TWO_SIDED|95.0|-3.19|5.11||Unadjusted p-value|Mixed Models Analysis|t (df, 233) = 0.46|Difference between the changes (EX+T - EX+P)|Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with a Compound Symmetry covariance structure.||5.11|-3.19|0.649
72450582|NCT02938923|144421062|SUPERIORITY||Mean Difference (Final Values)|2.5||||0.389|TWO_SIDED|95.0|-3.22|8.23||Unadjusted p-value|Mixed Models Analysis|t (df, 233) = 0.86|Difference between the changes (EX+T - EUC)|Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with a Compound Symmetry covariance structure.||8.23|-3.22|0.389
72391126|NCT03000439|144289758|OTHER||Difference in LS Mean|-0.53|||||TWO_SIDED|95.0|-3.04|1.98||||||DB Week 20: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||1.98|-3.04|
72391127|NCT03000439|144289758|OTHER||Difference in LS Mean|1.84|||||TWO_SIDED|95.0|-1.29|4.97||||||DB Week 24: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||4.97|-1.29|
72391128|NCT03000439|144289758|OTHER||Difference in LS Mean|-0.08|||||TWO_SIDED|95.0|-5.89|5.72||||||DB Week 28: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||5.72|-5.89|
72391129|NCT03000439|144289758|OTHER||Difference in LS Mean|-0.69|||||TWO_SIDED|95.0|-3.79|2.41||||||DB Week 32: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||2.41|-3.79|
72391130|NCT03000439|144289758|OTHER||Difference in LS Mean|-0.35|||||TWO_SIDED|95.0|-1.89|1.19||||||DB Week 36: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||1.19|-1.89|
72391131|NCT03000439|144289758|OTHER||Difference in LS Mean|-0.03|||||TWO_SIDED|95.0|-3.63|3.58||||||DB Week 40: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||3.58|-3.63|
72391132|NCT03000439|144289758|OTHER||Difference in LS Mean|-2.59|||||TWO_SIDED|95.0|-5.67|0.49||||||DB Week 44: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||0.49|-5.67|
72391133|NCT03000439|144289758|OTHER||Difference in LS Mean|-0.82|||||TWO_SIDED|95.0|-2.82|1.19||||||DB Week 48: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||1.19|-2.82|
72391134|NCT03000439|144289758|OTHER||Difference in LS Mean|-0.46|||||TWO_SIDED|95.0|-3.27|2.36||||||DB Week 52: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||2.36|-3.27|
72391135|NCT03000439|144289771|OTHER||Difference in LS Mean|0.86|||||TWO_SIDED|95.0|-0.08|1.79||||||DB week 4: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open-Label baseline value, and Open-Label baseline value by visit interaction.||1.79|-0.08|
72391136|NCT03000439|144289771|OTHER||Difference in LS Mean|1.32|||||TWO_SIDED|95.0|0.25|2.4||||||DB week 8: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open-Label baseline value, and Open-Label baseline value by visit interaction.||2.40|0.25|
72391137|NCT03000439|144289771|OTHER||Difference in LS Mean|1.43|||||TWO_SIDED|95.0|-0.79|3.66||||||DB week 12: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open-Label baseline value, and Open-Label baseline value by visit interaction.||3.66|-0.79|
72391138|NCT03000439|144289771|OTHER||Difference in LS Mean|0.02|||||TWO_SIDED|95.0|-0.7|0.74||||||DB week 16: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open-Label baseline value, and Open-Label baseline value by visit interaction.||0.74|-0.70|
72391139|NCT03000439|144289771|OTHER||Difference in LS Mean|0.11|||||TWO_SIDED|95.0|-0.43|0.64||||||DB week 20: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open-Label baseline value, and Open-Label baseline value by visit interaction.||0.64|-0.43|
72391140|NCT03000439|144289771|OTHER||Difference in LS Mean|0.44|||||TWO_SIDED|95.0|0.06|0.81||||||DB week 24: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open-Label baseline value, and Open-Label baseline value by visit interaction.||0.81|0.06|
72391141|NCT03000439|144289771|OTHER||Difference in LS Mean|0.21|||||TWO_SIDED|95.0|-1.64|2.06||||||DB week 28: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open-Label baseline value, and Open-Label baseline value by visit interaction.||2.06|-1.64|
72391142|NCT03000439|144289771|OTHER||Difference in LS Mean|0.49|||||TWO_SIDED|95.0|-0.04|1.03||||||DB week 32: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open-Label baseline value, and Open-Label baseline value by visit interaction.||1.03|-0.04|
72391143|NCT03000439|144289771|OTHER||Difference in LS Mean|0.35|||||TWO_SIDED|95.0|-0.09|0.79||||||DB week 36: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open-Label baseline value, and Open-Label baseline value by visit interaction.||0.79|-0.09|
72450583|NCT02938923|144421062|SUPERIORITY||Mean Difference (Final Values)|1.55||||0.598|TWO_SIDED|95.0|-4.22|7.31||Unadjusted p-value|Mixed Models Analysis|t (df, 233) = 0.53|Difference between the changes (EX+P - EUC)|Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with a Compound Symmetry covariance structure.||7.31|-4.22|0.598
72391144|NCT03000439|144289771|OTHER||Difference in LS Mean|0.52|||||TWO_SIDED|95.0|-0.23|1.28||||||DB week 40: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open-Label baseline value, and Open-Label baseline value by visit interaction.||1.28|-0.23|
72391145|NCT03000439|144289771|OTHER||Difference in LS Mean|-0.19|||||TWO_SIDED|95.0|-1.2|0.83||||||DB week 44: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open-Label baseline value, and Open-Label baseline value by visit interaction.||0.83|-1.20|
72391146|NCT03000439|144289771|OTHER||Difference in LS Mean|0.21|||||TWO_SIDED|95.0|-0.49|0.91||||||DB week 48: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open-Label baseline value, and Open-Label baseline value by visit interaction.||0.91|-0.49|
72391147|NCT03000439|144289771|OTHER||Difference in LS Mean|0.06|||||TWO_SIDED|95.0|-0.8|0.92||||||DB week 52: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open-Label baseline value, and Open-Label baseline value by visit interaction.||0.92|-0.80|
72450584|NCT02938923|144421062|SUPERIORITY||Mean Difference (Final Values)|0.88||||0.676|TWO_SIDED|95.0|-3.26|5.02||Unadjusted p-value|Mixed Models Analysis|t (df, 233) = 0.42|Difference between the changes (EX+T - EX+P)|Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with a Compound Symmetry covariance structure in the model with covariates.||5.02|-3.26|0.676
72450585|NCT02938923|144421062|SUPERIORITY||Mean Difference (Final Values)|2.48||||0.394|TWO_SIDED|95.0|-3.24|8.19||Unadjusted p-value|Mixed Models Analysis|t (df, 233) = 0.85|Difference between the changes (EX+T - EUC)|Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with a Compound Symmetry covariance structure in the model with covariates.||8.19|-3.24|0.394
72450586|NCT02938923|144421062|SUPERIORITY||Mean Difference (Final Values)|1.6||||0.585|TWO_SIDED|95.0|-4.15|7.35||Unadjusted p-value|Mixed Models Analysis|t (df, 233) = 0.55|Difference between the changes (EX+P - EUC)|Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with a Compound Symmetry covariance structure in the model with covariates.||7.35|-4.15|0.585
72450587|NCT02938923|144421062|SUPERIORITY||Mean Difference (Final Values)|0.55||||0.794|TWO_SIDED|95.0|-3.56|4.65||Unadjusted p-value|Mixed Models Analysis|t (df, 233) = 0.26|Difference between the changes (EX+T - EX+P)|Comparison based on contrasts between two groups at baseline to three months from mixed model ANOVA with a Compound Symmetry covariance structure.||4.65|-3.56|0.794
72450588|NCT02938923|144421062|SUPERIORITY||Mean Difference (Final Values)|2.27||||0.449|TWO_SIDED|95.0|-3.62|8.16||Unadjusted p-value|Mixed Models Analysis|t (df, 233) = 0.76|Difference between the changes (EX+T - EUC)|Comparison based on contrasts between two groups at baseline to three months from mixed model ANOVA with a Compound Symmetry covariance structure.||8.16|-3.62|0.449
72450589|NCT02938923|144421062|SUPERIORITY||Mean Difference (Final Values)|1.72||||0.567|TWO_SIDED|95.0|-4.2|7.64||Unadjusted p-value|Mixed Models Analysis|t (df, 233) = 0.57|Difference between the changes (EX+P - EUC)|Comparison based on contrasts between two groups at baseline to three months from mixed model ANOVA with a Compound Symmetry covariance structure.||7.64|-4.20|0.567
72450590|NCT02938923|144421062|SUPERIORITY||Mean Difference (Final Values)|0.55||||0.794|TWO_SIDED|95.0|-3.56|4.65||Unadjusted p-value|Mixed Models Analysis|t (df, 233) = 0.26|Difference between the changes (EX+T - EX+P)|Comparison based on contrasts between two groups at baseline to three months from mixed model ANOVA with a Compound Symmetry covariance structure in the model with covariates.||4.65|-3.56|0.794
72450591|NCT02938923|144421062|SUPERIORITY||Mean Difference (Final Values)|1.89||||0.526|TWO_SIDED|95.0|-3.97|7.75||Unadjusted p-value|Mixed Models Analysis|t (df, 233) = 0.64|Difference between the changes (EX+T - EUC)|Comparison based on contrasts between two groups at baseline to three months from mixed model ANOVA with a Compound Symmetry covariance structure in the model with covariates.||7.75|-3.97|0.526
72450592|NCT02938923|144421062|SUPERIORITY||Mean Difference (Final Values)|1.34||||0.654|TWO_SIDED|95.0|-4.55|7.23||Unadjusted p-value|Mixed Models Analysis|t (df, 233) = 0.45|Difference between the changes (EX+P - EUC)|Comparison based on contrasts between two groups at baseline to three months from mixed model ANOVA with a Compound Symmetry covariance structure in the model with covariates.||7.23|-4.55|0.654
72450593|NCT02938923|144421063|SUPERIORITY||Mean Difference (Final Values)|0.63||||0.597|TWO_SIDED|95.0|-1.72|2.98||Unadjusted p-value|Mixed Models Analysis|t (df, 233) = 0.53|Difference between the changes (EX+T - EX+P) on Physical Health domain|Comparison of Physical Health Domain based on contrasts between two groups at baseline to six months from mixed model ANOVA with a Heterogeneous Toeplitz covariance structure.||2.98|-1.72|0.597
72450594|NCT02938923|144421063|SUPERIORITY||Mean Difference (Final Values)|-2.18||||0.184|TWO_SIDED|95.0|-5.41|1.04||Unadjusted p-value|Mixed Models Analysis|t (df, 233) = -1.33|Difference between the changes (EX+T - EUC) on Physical Health domain|Comparison of Physical Health Domain based on contrasts between two groups at baseline to six months from mixed model ANOVA with a Heterogeneous Toeplitz covariance structure.||1.04|-5.41|0.184
72391148|NCT03000439|144289772|OTHER||Difference in LS Mean|0.29|||||TWO_SIDED|95.0|-0.43|1.0||||||DB Week 4: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||1.00|-0.43|
72391149|NCT03000439|144289772|OTHER||Difference in LS Mean|1.01|||||TWO_SIDED|95.0|-0.06|2.08||||||DB Week 8: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||2.08|-0.06|
72391150|NCT03000439|144289772|OTHER||Difference in LS Mean|1.25|||||TWO_SIDED|95.0|-1.13|3.64||||||DB Week 12: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||3.64|-1.13|
72391151|NCT03000439|144289772|OTHER||Difference in LS Mean|0.1|||||TWO_SIDED|95.0|-0.68|0.88||||||DB Week 16: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||0.88|-0.68|
72391152|NCT03000439|144289772|OTHER||Difference in LS Mean|-0.13|||||TWO_SIDED|95.0|-0.58|0.33||||||DB Week 20: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||0.33|-0.58|
72391153|NCT03000439|144289772|OTHER||Difference in LS Mean|0.32|||||TWO_SIDED|95.0|-0.03|0.68||||||DB Week 24: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||0.68|-0.03|
72391154|NCT03000439|144289772|OTHER||Difference in LS Mean|-0.17|||||TWO_SIDED|95.0|-2.42|2.08||||||DB Week 28: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||2.08|-2.42|
72391155|NCT03000439|144289772|OTHER||Difference in LS Mean|0.42|||||TWO_SIDED|95.0|-0.14|0.97||||||DB Week 32: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||0.97|-0.14|
72391156|NCT03000439|144289772|OTHER||Difference in LS Mean|0.32|||||TWO_SIDED|95.0|-0.15|0.79||||||DB Week 36: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||0.79|-0.15|
72391157|NCT03000439|144289772|OTHER||Difference in LS Mean|0.68|||||TWO_SIDED|95.0|-0.14|1.49||||||DB Week 40: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||1.49|-0.14|
72619676|NCT05287685|144770228|SUPERIORITY|||||||0.02|||||||ANCOVA|||ANCOVA analysis for the pilot RCT, comparing the outcome variable at posttest (Week 8) between the two groups, with pretest (baseline) scores, annual household income and household size (to approximate income-to-needs ratio), caregiver education, and child externalizing behavior as covariates.||||.02
72619677|NCT05287685|144770228|SUPERIORITY|||||||0.04|||||||ANCOVA|||ANCOVA analysis for the pilot RCT, comparing the outcome variable at follow-up (Week 16) between the two groups, with pretest (baseline) scores, annual household income and household size (to approximate income-to-needs ratio), caregiver education, and child externalizing behavior as covariates.||||.04
72619678|NCT05287685|144770229|OTHER|||||||0.88|||||||t-test, 2 sided|||Preliminary outcome analysis for the open trial (n = 7). The analysis was a paired samples t-test comparing baseline (week 0) to posttest (week 8) scores.||||.88
72619679|NCT05287685|144770229|OTHER|||||||0.87|||||||t-test, 2 sided|||Preliminary outcome analysis for the open trial (n = 7). The analysis was a paired samples t-test comparing baseline(week 0) to follow-up (week 16) scores.||||.87
72619680|NCT05287685|144770229|SUPERIORITY|||||||0.1|||||||ANCOVA|||ANCOVA analysis for the pilot RCT, comparing the outcome variable at posttest (Week 8) between the two groups, with pretest (baseline) scores, annual household income and household size (to approximate income-to-needs ratio), caregiver education, and child externalizing behavior as covariates.||||.10
72391158|NCT03000439|144289772|OTHER||Difference in LS Mean|-0.16|||||TWO_SIDED|95.0|-1.28|0.96||||||DB Week 44: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||0.96|-1.28|
72391159|NCT03000439|144289772|OTHER||Difference in LS Mean|0.37|||||TWO_SIDED|95.0|-0.43|1.16||||||DB Week 48: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||1.16|-0.43|
72391160|NCT03000439|144289772|OTHER||Difference in LS Mean|0.24|||||TWO_SIDED|95.0|-0.82|1.3||||||DB Week 52: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||1.30|-0.82|
72450595|NCT02938923|144421063|SUPERIORITY||Mean Difference (Final Values)|-2.82||||0.089|TWO_SIDED|95.0|-6.07|0.44||Unadjusted p-value|Mixed Models Analysis|t (df, 233) = -1.71|Difference between the changes (EX+P - EUC) on Physical Health domain|Comparison of Physical Health Domain based on contrasts between two groups at baseline to six months from mixed model ANOVA with a Heterogeneous Toeplitz covariance structure.||0.44|-6.07|0.089
72450596|NCT02938923|144421063|SUPERIORITY||Mean Difference (Final Values)|0.64||||0.635|TWO_SIDED|95.0|-2.01|3.28||Unadjusted p-value|Mixed Models Analysis|t (df, 233) = 0.47|Difference in the changes (EX+T - EX+P)|Comparison of Physical Health Domain based on contrasts between two groups at baseline to six months from mixed model ANOVA with a Heterogeneous Toeplitz covariance structure in the model with covariates.||3.28|-2.01|0.635
72619681|NCT05287685|144770229|SUPERIORITY|||||||0.9|||||||ANCOVA|||ANCOVA analysis for the pilot RCT, comparing the outcome variable at follow-up (Week 16) between the two groups, with pretest (baseline) scores, annual household income and household size (to approximate income-to-needs ratio), caregiver education, and child externalizing behavior as covariates.||||.90
72391161|NCT03000439|144289773|OTHER||Difference in LS Mean|0.21|||||TWO_SIDED|95.0|-0.07|0.5||||||DB week 4: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, open-label baseline value, and open-label baseline value by visit interaction.||0.50|-0.07|
72391162|NCT03000439|144289773|OTHER||Difference in LS Mean|0.09|||||TWO_SIDED|95.0|-0.15|0.32||||||DB week 8: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, open-label baseline value, and open-label baseline value by visit interaction.||0.32|-0.15|
72450597|NCT02938923|144421063|SUPERIORITY||Mean Difference (Final Values)|-2.15||||0.242|TWO_SIDED|95.0|-5.76|1.46||Unadjusted p-value|Mixed Models Analysis|t (df, 233) = -1.17|Difference between the changes (EX+T - EUC)|Comparison of Physical Health Domain based on contrasts between two groups at baseline to six months from mixed model ANOVA with a Heterogeneous Toeplitz covariance structure in the model with covariates.||1.46|-5.76|0.242
72619682|NCT05287685|144770230|EQUIVALENCE|Analysis to test whether groups had equivalent levels of satisfaction with treatment (defined as the groups not being significantly different at the level of p\<.05).||||||0.8|||||||t-test, 2 sided|||T-test analysis for the pilot RCT, comparing the outcome variable at posttest (Week 8) between the two groups.||||.80
72619683|NCT05287685|144770231|OTHER|||||||0.35|||||||t-test, 2 sided|||Preliminary outcome analysis for the open trial (n = 7). The analysis was a paired samples t-test comparing baseline (week 0) to posttest (week 8) scores.||||.35
72619684|NCT05287685|144770231|OTHER|||||||0.049|||||||t-test, 2 sided|||Preliminary outcome analysis for the open trial (n = 7). The analysis was a paired samples t-test comparing baseline(week 0) to follow-up (week 16) scores.||||.049
72619685|NCT05287685|144770231|SUPERIORITY|||||||0.45|||||||ANCOVA|||ANCOVA analysis for the pilot RCT, comparing the outcome variable at posttest (Week 8) between the two groups, with pretest (baseline) scores, annual household income and household size (to approximate income-to-needs ratio), caregiver education, and child externalizing behavior as covariates.||||.45
72619686|NCT05287685|144770231|SUPERIORITY|||||||0.2|||||||ANCOVA|||ANCOVA analysis for the pilot RCT, comparing the outcome variable at follow-up (Week 16) between the two groups, with pretest (baseline) scores, annual household income and household size (to approximate income-to-needs ratio), caregiver education, and child externalizing behavior as covariates.||||.20
72619687|NCT05287685|144770232|OTHER|||||||0.006|||||||t-test, 2 sided|||Preliminary outcome analysis for the open trial (n = 7). The analysis was a paired samples t-test comparing baseline (week 0) to posttest (week 8) scores.||||.006
72619688|NCT05287685|144770232|OTHER|||||||0.011|||||||t-test, 2 sided|||Preliminary outcome analysis for the open trial (n = 7). The analysis was a paired samples t-test comparing baseline(week 0) to follow-up (week 16) scores.||||.011
72619689|NCT05287685|144770232|SUPERIORITY|||||||0.22|||||||ANCOVA|||ANCOVA analysis for the pilot RCT, comparing the outcome variable at posttest (Week 8) between the two groups, with pretest (baseline) scores, annual household income and household size (to approximate income-to-needs ratio), caregiver education, and child externalizing behavior as covariates.||||.22
72498957|NCT00348140|144528170|SUPERIORITY||Mean Difference (Net)|0.1||||0.596|TWO_SIDED|95.0|-0.2|0.3|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|For Week 24||0.3|-0.2|0.596
72498958|NCT00348140|144528170|SUPERIORITY||Mean Difference (Net)|-0.1||||0.452|TWO_SIDED|95.0|-0.4|0.2|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|For Week 36||0.2|-0.4|0.452
72498959|NCT00348140|144528170|SUPERIORITY||Mean Difference (Net)|-0.1||||0.429|TWO_SIDED|95.0|-0.4|0.2|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|For Week 36||0.2|-0.4|0.429
72498960|NCT00348140|144528171|SUPERIORITY||Mean Difference (Net)|-0.3||||0.386|TWO_SIDED|95.0|-0.8|0.3|||ANCOVA|||||0.3|-0.8|0.386
72391163|NCT03000439|144289773|OTHER||Difference in LS Mean|0.05|||||TWO_SIDED|95.0|-0.17|0.28||||||DB week 12: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, open-label baseline value, and open-label baseline value by visit interaction.||0.28|-0.17|
72498961|NCT00348140|144528171|SUPERIORITY||Mean Difference (Net)|0.0||||0.999|TWO_SIDED|95.0|-0.6|0.6|||ANCOVA|||||0.6|-0.6|0.999
72498962|NCT00348140|144528172|SUPERIORITY||Mean Difference (Net)|1.1||||0.09|TWO_SIDED|95.0|-0.2|2.5|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|For Week 8||2.5|-0.2|0.090
72498963|NCT00348140|144528172|SUPERIORITY||Mean Difference (Net)|0.0||||0.957|TWO_SIDED|95.0|-1.3|1.3|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|For Week 8||1.3|-1.3|0.957
72498964|NCT00348140|144528172|SUPERIORITY||Mean Difference (Net)|0.7||||0.395|TWO_SIDED|95.0|-0.9|2.2|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|For Week 16||2.2|-0.9|0.395
72498965|NCT00348140|144528172|SUPERIORITY||Mean Difference (Net)|-0.9||||0.275|TWO_SIDED|95.0|-2.5|0.7|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|For Week 16||0.7|-2.5|0.275
72391164|NCT03000439|144289773|OTHER||Difference in LS Mean|0.1|||||TWO_SIDED|95.0|-0.16|0.36||||||DB week 16: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, open-label baseline value, and open-label baseline value by visit interaction.||0.36|-0.16|
72391165|NCT03000439|144289773|OTHER||Difference in LS Mean|0.19|||||TWO_SIDED|95.0|-0.01|0.38||||||DB week 20: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, open-label baseline value, and open-label baseline value by visit interaction.||0.38|-0.01|
72391166|NCT03000439|144289773|OTHER||Difference in LS Mean|0.12|||||TWO_SIDED|95.0|-0.12|0.35||||||DB week 24: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, open-label baseline value, and open-label baseline value by visit interaction.||0.35|-0.12|
72391167|NCT03000439|144289773|OTHER||Difference in LS Mean|0.07|||||TWO_SIDED|95.0|-0.18|0.31||||||DB week 28: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, open-label baseline value, and open-label baseline value by visit interaction.||0.31|-0.18|
72391168|NCT03000439|144289773|OTHER||Difference in LS Mean|0.15|||||TWO_SIDED|95.0|-0.06|0.37||||||DB week 32: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, open-label baseline value, and open-label baseline value by visit interaction.||0.37|-0.06|
72391169|NCT03000439|144289773|OTHER||Difference in LS Mean|0.11|||||TWO_SIDED|95.0|-0.14|0.36||||||DB week 36: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, open-label baseline value, and open-label baseline value by visit interaction.||0.36|-0.14|
72391170|NCT03000439|144289773|OTHER||Difference in LS Mean|0.16|||||TWO_SIDED|95.0|-0.06|0.38||||||DB week 40: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, open-label baseline value, and open-label baseline value by visit interaction.||0.38|-0.06|
72391171|NCT03000439|144289773|OTHER||Difference in LS Mean|0.04|||||TWO_SIDED|95.0|-0.22|0.3||||||DB week 44: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, open-label baseline value, and open-label baseline value by visit interaction.||0.30|-0.22|
72391172|NCT03000439|144289773|OTHER||Difference in LS Mean|0.09|||||TWO_SIDED|95.0|-0.2|0.38||||||DB week 48: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, open-label baseline value, and open-label baseline value by visit interaction.||0.38|-0.20|
72391173|NCT03000439|144289773|OTHER||Difference in LS Mean|0.09|||||TWO_SIDED|95.0|-0.24|0.42||||||DB week 52: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, open-label baseline value, and open-label baseline value by visit interaction.||0.42|-0.24|
72391174|NCT03000439|144289774|OTHER||Difference in LS Mean|0.07|||||TWO_SIDED|95.0|-0.1|0.24||||||DB Week 4: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||0.24|-0.10|
72391175|NCT03000439|144289774|OTHER||Difference in LS Mean|-0.02|||||TWO_SIDED|95.0|-0.19|0.15||||||DB Week 8: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||0.15|-0.19|
72391176|NCT03000439|144289774|OTHER||Difference in LS Mean|-0.01|||||TWO_SIDED|95.0|-0.19|0.16||||||DB Week 12: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||0.16|-0.19|
72391177|NCT03000439|144289774|OTHER||Difference in LS Mean|0.01|||||TWO_SIDED|95.0|-0.2|0.23||||||DB Week 16: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||0.23|-0.20|
72391178|NCT03000439|144289774|OTHER||Difference in LS Mean|0.15|||||TWO_SIDED|95.0|-0.02|0.32||||||DB Week 20: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||0.32|-0.02|
72619690|NCT05287685|144770232|SUPERIORITY|||||||0.25|||||||ANCOVA|||ANCOVA analysis for the pilot RCT, comparing the outcome variable at follow-up (Week 16) between the two groups, with pretest (baseline) scores, annual household income and household size (to approximate income-to-needs ratio), caregiver education, and child externalizing behavior as covariates.||||.25
72391179|NCT03000439|144289774|OTHER||Difference in LS Mean|0.15|||||TWO_SIDED|95.0|-0.09|0.4||||||DB Week 24: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||0.40|-0.09|
72391180|NCT03000439|144289774|OTHER||Difference in LS Mean|0.09|||||TWO_SIDED|95.0|-0.16|0.34||||||DB Week 28: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||0.34|-0.16|
72391181|NCT03000439|144289774|OTHER||Difference in LS Mean|0.15|||||TWO_SIDED|95.0|-0.05|0.36||||||DB Week 32: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||0.36|-0.05|
72391182|NCT03000439|144289774|OTHER||Difference in LS Mean|0.16|||||TWO_SIDED|95.0|-0.1|0.43||||||DB Week 36: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||0.43|-0.10|
72391183|NCT03000439|144289774|OTHER||Difference in LS Mean|0.17|||||TWO_SIDED|95.0|-0.06|0.39||||||DB Week 40: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||0.39|-0.06|
72391184|NCT03000439|144289774|OTHER||Difference in LS Mean|0.04|||||TWO_SIDED|95.0|-0.22|0.3||||||DB Week 44: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||0.30|-0.22|
72391185|NCT03000439|144289774|OTHER||Difference in LS Mean|0.15|||||TWO_SIDED|95.0|-0.18|0.49||||||DB Week 48: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||0.49|-0.18|
72391186|NCT03000439|144289774|OTHER||Difference in LS Mean|0.16|||||TWO_SIDED|95.0|-0.23|0.55||||||DB Week 52: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||0.55|-0.23|
72391187|NCT03000439|144289775|OTHER||Difference in LS Mean|0.21|||||TWO_SIDED|95.0|-0.97|1.4||||||DB week 4: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open label baseline value, and Open-label baseline value by visit interaction.||1.40|-0.97|
72391188|NCT03000439|144289775|OTHER||Difference in LS Mean|0.58|||||TWO_SIDED|95.0|-0.68|1.84||||||DB week 8: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open label baseline value, and Open-label baseline value by visit interaction.||1.84|-0.68|
72391189|NCT03000439|144289775|OTHER||Difference in LS Mean|1.2|||||TWO_SIDED|95.0|-0.77|3.16||||||DB week 12: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open label baseline value, and Open-label baseline value by visit interaction.||3.16|-0.77|
72391190|NCT03000439|144289775|OTHER||Difference in LS Mean|-0.06|||||TWO_SIDED|95.0|-1.3|1.18||||||DB week 16: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open label baseline value, and Open-label baseline value by visit interaction.||1.18|-1.30|
72391191|NCT03000439|144289775|OTHER||Difference in LS Mean|0.26|||||TWO_SIDED|95.0|-0.29|0.82||||||DB week 20: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open label baseline value, and Open-label baseline value by visit interaction.||0.82|-0.29|
72391192|NCT03000439|144289775|OTHER||Difference in LS Mean|0.09|||||TWO_SIDED|95.0|-0.46|0.64||||||DB week 24: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open label baseline value, and Open-label baseline value by visit interaction.||0.64|-0.46|
72391193|NCT03000439|144289775|OTHER||Difference in LS Mean|-0.46|||||TWO_SIDED|95.0|-2.05|1.13||||||DB week 28: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open label baseline value, and Open-label baseline value by visit interaction.||1.13|-2.05|
72391194|NCT03000439|144289775|OTHER||Difference in LS Mean|0.35|||||TWO_SIDED|95.0|-0.18|0.88||||||DB week 32: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open label baseline value, and Open-label baseline value by visit interaction.||0.88|-0.18|
72391195|NCT03000439|144289775|OTHER||Difference in LS Mean|0.31|||||TWO_SIDED|95.0|-0.26|0.88||||||DB week 36: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open label baseline value, and Open-label baseline value by visit interaction.||0.88|-0.26|
72391196|NCT03000439|144289775|OTHER||Difference in LS Mean|0.28|||||TWO_SIDED|95.0|-0.43|0.99||||||DB week 40: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open label baseline value, and Open-label baseline value by visit interaction.||0.99|-0.43|
72391197|NCT03000439|144289775|OTHER||Difference in LS Mean|0.29|||||TWO_SIDED|95.0|-0.45|1.03||||||DB week 44: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open label baseline value, and Open-label baseline value by visit interaction.||1.03|-0.45|
72619691|NCT02777190|144770301|NON_INFERIORITY|Margin of 4 hours|Mean Difference (Final Values)|-1.7||||0.09|ONE_SIDED|97.5||6.7|||t-test, 1 sided|one-sided two-sample t-test with alpha=0.025|Difference calculated as oral minus vaginal|||6.7||0.09
72450598|NCT02938923|144421063|SUPERIORITY||Mean Difference (Final Values)|-2.79||||0.132|TWO_SIDED|95.0|-6.42|0.85||Unadjusted p-value|Mixed Models Analysis|t (df, 233) = -1.51|Difference between the changes (EX+P - EUC)|Comparison of Physical Health Domain based on contrasts between two groups at baseline to six months from mixed model ANOVA with a Heterogeneous Toeplitz covariance structure in the model with covariates.||0.85|-6.42|0.132
72619692|NCT02777190|144770302|SUPERIORITY|||||||0.54|||||||t-test, 2 sided|||||||0.54
72619693|NCT02777190|144770303|SUPERIORITY|||||||0.64|||||||t-test, 2 sided|||||||0.64
72450599|NCT02938923|144421063|SUPERIORITY||Mean Difference (Final Values)|1.52||||0.193|TWO_SIDED|95.0|-0.77|3.81||Unadjusted p-value|Mixed Models Analysis|t (df, 233) = 1.31|Difference between the changes (EX+T - EX+P)|Comparison of Physical Health Domain based on contrasts between two groups at baseline to three months from mixed model ANOVA with a Heterogeneous Toeplitz covariance structure.||3.81|-0.77|0.193
72450600|NCT02938923|144421063|SUPERIORITY||Mean Difference (Final Values)|1.44||||0.39|TWO_SIDED|95.0|-1.86|4.75||Unadjusted p-value|Mixed Models Analysis|t (df, 233) = 0.86|Difference between the changes (EX+T - EUC)|Comparison of Physical Health Domain based on contrasts between two groups at baseline to three months from mixed model ANOVA with a Heterogeneous Toeplitz covariance structure.||4.75|-1.86|0.390
72619694|NCT02777190|144770304|SUPERIORITY|||||||0.12|||||||Fisher Exact|||||||0.12
72450601|NCT02938923|144421063|SUPERIORITY||Mean Difference (Final Values)|-0.07||||0.965|TWO_SIDED|95.0|-3.39|3.25||Unadjusted p-value|Mixed Models Analysis|t (df, 233) = -0.04|Difference between the changes (EX+P - EUC)|Comparison of Physical Health Domain based on contrasts between two groups at baseline to three months from mixed model ANOVA with a Heterogeneous Toeplitz covariance structure.||3.25|-3.39|0.965
72450602|NCT02938923|144421063|SUPERIORITY||Mean Difference (Final Values)|1.52||||0.195|TWO_SIDED|95.0|-0.79|3.82||Unadjusted p-value|Mixed Models Analysis|t (df, 233) = 1.30|Difference between the changes (EX+T - EX+P)|Comparison of Physical Health Domain based on contrasts between two groups at baseline to three months from mixed model ANOVA with a Heterogeneous Toeplitz covariance structure in the model with covariates.||3.82|-0.79|0.195
72450603|NCT02938923|144421063|SUPERIORITY||Mean Difference (Final Values)|1.35||||0.418|TWO_SIDED|95.0|-1.93|4.63||Unadjusted p-value|Mixed Models Analysis|t (df, 233) = 0.81|Difference between the changes (EX+T - EUC)|Comparison of Physical Health Domain based on contrasts between two groups at baseline to three months from mixed model ANOVA with a Heterogeneous Toeplitz covariance structure in the model with covariates.||4.63|-1.93|0.418
72450604|NCT02938923|144421063|SUPERIORITY||Mean Difference (Final Values)|-0.17||||0.921|TWO_SIDED|95.0|-3.46|3.13||Unadjusted p-value|Mixed Models Analysis|t (df, 233) = -0.10|Difference between the changes (EX+P - EUC)|Comparison of Physical Health Domain based on contrasts between two groups at baseline to three months from mixed model ANOVA with a Heterogeneous Toeplitz covariance structure in the model with covariates.||3.13|-3.46|0.921
72450605|NCT02938923|144421063|SUPERIORITY||Mean Difference (Final Values)|2.31||||0.078|TWO_SIDED|95.0|-0.26|4.88||Unadjusted p-value|Mixed Models Analysis|t (df, 232) = 1.77|Difference between the changes (EX+T - EX+P)|Comparison of Mental Health Domain based on contrasts between two groups at baseline to six months from mixed model ANOVA with a Heterogeneous AR Autoregressive (1) covariance structure.||4.88|-0.26|0.078
72450606|NCT02938923|144421063|SUPERIORITY||Mean Difference (Final Values)|-0.04||||0.982|TWO_SIDED|95.0|-3.51|3.43||Unadjusted p-value|Mixed Models Analysis|t (df, 232) = -0.02|Difference between the changes (EX+T - EUC)|Comparison of Mental Health Domain based on contrasts between two groups at baseline to six months from mixed model ANOVA with a Heterogeneous AR Autoregressive (1) covariance structure.||3.43|-3.51|0.982
72450607|NCT02938923|144421063|SUPERIORITY||Mean Difference (Final Values)|-2.35||||0.187|TWO_SIDED|95.0|-5.85|1.15||Unadjusted p-value|Mixed Models Analysis|t (df, 232) = -1.32|Difference between the changes (EX+P - EUC)|Comparison of Mental Health Domain based on contrasts between two groups at baseline to six months from mixed model ANOVA with a Heterogeneous AR Autoregressive (1) covariance structure.||1.15|-5.85|0.187
72450608|NCT02938923|144421063|SUPERIORITY||Mean Difference (Final Values)|2.16||||0.08|TWO_SIDED|95.0|-0.26|4.58||Unadjusted p-value|Mixed Models Analysis|t (df, 232) = 1.76|Difference of the changes (EX+T - EX+P)|Comparison of Mental Health Domain based on contrasts between two groups at baseline to six months from mixed model ANOVA with a Heterogeneous AR Autoregressive (1) covariance structure in the model with covariates.||4.58|-0.26|0.080
72450609|NCT02938923|144421063|SUPERIORITY||Mean Difference (Final Values)|-0.47||||0.781|TWO_SIDED|95.0|-3.76|2.83||Unadjusted p-value|Mixed Models Analysis|t (df, 232) = -0.28|Difference between the changes (EX+T - EUC)|Comparison of Mental Health Domain based on contrasts between two groups at baseline to six months from mixed model ANOVA with a Heterogeneous AR Autoregressive (1) covariance structure in the model with covariates.||2.83|-3.76|0.781
72450610|NCT02938923|144421063|SUPERIORITY||Mean Difference (Final Values)|-2.63||||0.121|TWO_SIDED|95.0|-5.94|0.69||Unadjusted p-value|Mixed Models Analysis|t (df, 232) = -1.56|Difference between the changes (EX+P - EUC)|Comparison of Mental Health Domain based on contrasts between two groups at baseline to six months from mixed model ANOVA with a Heterogeneous AR Autoregressive (1) covariance structure in the model with covariates.||0.69|-5.94|0.121
72450611|NCT02938923|144421063|SUPERIORITY||Mean Difference (Final Values)|1.58||||0.148|TWO_SIDED|95.0|-0.57|3.73||Unadjusted p-value|Mixed Models Analysis|t (df, 232) = 1.45|Difference between the changes (EX+T - EX+P)|Comparison of Mental Health Domain based on contrasts between two groups at baseline to three months from mixed model ANOVA with a Heterogeneous AR Autoregressive (1) covariance structure.||3.73|-0.57|0.148
72619695|NCT02777190|144770305|SUPERIORITY|||||||0.34|||||||Fisher Exact|||||||0.34
72619696|NCT02777190|144770306|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.00
72619697|NCT02777190|144770307|SUPERIORITY|||||||0.6|||||||Fisher Exact|||||||0.60
72619698|NCT02777190|144770309|SUPERIORITY|||||||0.4|||||||Fisher Exact|||||||0.40
72619699|NCT02777190|144770310|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.00
72619700|NCT02777190|144770311|SUPERIORITY|||||||0.04|||||||Fisher Exact|||||||0.04
72619701|NCT02777190|144770312|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.00
72619702|NCT02777190|144770313|SUPERIORITY|||||||0.12|||||||Fisher Exact|||||||0.12
72619703|NCT01452789|144770321|SUPERIORITY||||||<|0.05|||||||van Elteren|||||||<0.05
72619704|NCT01452789|144770322|SUPERIORITY||||||<|0.05|||||||van Elteren|||||||<0.05
72619705|NCT01452789|144770323|SUPERIORITY||||||<|0.05|||||||Cochran-Mantel-Haenszel|||||||<0.05
72450612|NCT02938923|144421063|SUPERIORITY||Mean Difference (Final Values)|-0.6||||0.699|TWO_SIDED|95.0|-3.64|2.45||Unadjusted p-value|Mixed Models Analysis|t (df, 232) = -0.39|Differences between the changes (EX+T - EUC)|Comparison of Mental Health Domain based on contrasts between two groups at baseline to three months from mixed model ANOVA with a Heterogeneous AR Autoregressive (1) covariance structure.||2.45|-3.64|0.699
72450613|NCT02938923|144421063|SUPERIORITY||Mean Difference (Final Values)|-2.18||||0.163|TWO_SIDED|95.0|-5.24|0.89||Unadjusted p-value|Mixed Models Analysis|t (df, 232) = -1.4|Difference in the changes (EX+P - EUC)|Comparison of Mental Health Domain based on contrasts between two groups at baseline to three months from mixed model ANOVA with a Heterogeneous AR Autoregressive (1) covariance structure.||0.89|-5.24|0.163
72450614|NCT02938923|144421063|SUPERIORITY||Mean Difference (Final Values)|1.59||||0.137|TWO_SIDED|95.0|-0.51|3.69||Unadjusted p-value|Mixed Models Analysis|t (df, 232) = 1.49|Difference between the changes (EX+T - EX+P)|Comparison of Mental Health Domain based on contrasts between two groups at baseline to three months from mixed model ANOVA with a Heterogeneous AR Autoregressive (1) covariance structure in the model with covariates.||3.69|-0.51|0.137
72450615|NCT02938923|144421063|SUPERIORITY||Mean Difference (Final Values)|-0.69||||0.648|TWO_SIDED|95.0|-3.68|2.29||Unadjusted p-value|Mixed Models Analysis|t (df, 232) = -0.46|Difference between the changes (EX+T - EUC)|Comparison of Mental Health Domain based on contrasts between two groups at baseline to three months from mixed model ANOVA with a Heterogeneous AR Autoregressive (1) covariance structure in the model with covariates.||2.29|-3.68|0.648
72450616|NCT02938923|144421063|SUPERIORITY||Mean Difference (Final Values)|-2.28||||0.135|TWO_SIDED|95.0|-5.29|0.72||Unadjusted p-value|Mixed Models Analysis|t (df, 232) = -1.50|Difference between the changes (EX+P - EUC)|Comparison of Mental Health Domain based on contrasts between two groups at baseline to three months from mixed model ANOVA with a Heterogeneous AR Autoregressive (1) covariance structure in the model with covariates.||0.72|-5.29|0.135
72450617|NCT02938923|144421064|SUPERIORITY||Mean Difference (Final Values)|-0.008||||0.821|TWO_SIDED|95.0|-0.073|0.058||Unadjusted p-value|Mixed Models Analysis|t (df, 92) = -0.23|Difference between the changes (EX+T - EX+P)|Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with an Autoregressive AR(1) covariance structure.||0.058|-0.073|0.821
72450618|NCT02938923|144421064|SUPERIORITY||Mean Difference (Final Values)|0.013||||0.789|TWO_SIDED|95.0|-0.082|0.108||Unadjusted p-value|Mixed Models Analysis|t (df, 92) = 0.27|Difference between the changes (EX+T - EUC)|Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with an Autoregressive AR(1) covariance structure.||0.108|-0.082|0.789
72450619|NCT02938923|144421064|SUPERIORITY||Mean Difference (Final Values)|0.02||||0.672|TWO_SIDED|95.0|-0.075|0.116||Unadjusted p-value|Mixed Models Analysis|t (df, 92) = 0.42|Difference between the changes (EX+P - EUC)|Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with an Autoregressive AR(1) covariance structure.||0.116|-0.075|0.672
72450620|NCT02938923|144421064|SUPERIORITY||Mean Difference (Final Values)|-0.002||||0.703|TWO_SIDED|95.0|-0.013|0.009||Unadjusted p-value|Mixed Models Analysis|t (df, 92) = -0.38||Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with an Autoregressive (1) covariance structure in the model with covariates.|Difference between the changes (EX+T - EX+P)|0.009|-0.013|0.703
72391198|NCT03000439|144289775|OTHER||Difference in LS Mean|0.22|||||TWO_SIDED|95.0|-0.63|1.08||||||DB week 48: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open label baseline value, and Open-label baseline value by visit interaction.||1.08|-0.63|
72450621|NCT02938923|144421064|SUPERIORITY||Mean Difference (Final Values)|-0.002||||0.803|TWO_SIDED|95.0|-0.017|0.014||Unadjusted p-value|Mixed Models Analysis|t (df, 92) = -0.25||Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with an Autoregressive (1) covariance structure in the model with covariates.|Difference between the changes (EX+T - EUC)|0.014|-0.017|0.803
72450622|NCT02938923|144421064|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.991|TWO_SIDED|95.0|-0.015|0.016||Unadjusted p-value|Mixed Models Analysis|t (df, 92) = 0.01||Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with an Autoregressive (1) covariance structure in the model with covariates.|Difference between the changes (EX+P - EUC)|0.016|-0.015|0.991
72450623|NCT05932407|144421074|SUPERIORITY||Hazard Ratio (HR)|0.5|||||TWO_SIDED|95.0|0.1|2.0||||||Crude hazard ratio of Vortioxetine Tablets to SSRIs for intracranial hemorrhage was reported. Crude hazard ratio of Vortioxetine Tablet Treatment group relative to the control group (SSRI Treatment group) was calculated by the rate of Vortioxetine Tablet Treatment group divided by the rate of SSRI Treatment group.||2.0|0.1|
72450624|NCT05932407|144421074|SUPERIORITY|Adjusted hazard ratio was adjusted from crude hazard ratio by covariance 1 (age and gender), and covariance 2 (antithrombotic drug administration, NSAID administration, and hypertension).|Hazard Ratio (HR)|0.5|||||TWO_SIDED|95.0|0.1|1.9||||||Adjusted hazard ratio of Vortioxetine Tablets to SSRIs for intracranial hemorrhage was reported. Adjusted hazard ratio of Vortioxetine Tablet Treatment group relative to the control group (SSRI Treatment group) was calculated by the rate of Vortioxetine Tablet Treatment group divided by the rate of SSRI Treatment group.||1.9|0.1|
72391199|NCT03000439|144289775|OTHER||Difference in LS Mean|0.45|||||TWO_SIDED|95.0|-0.66|1.57||||||DB week 52: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open label baseline value, and Open-label baseline value by visit interaction.||1.57|-0.66|
72450625|NCT04181736|144421080|OTHER||F-statistic|6.621||||0.02|TWO_SIDED|||||The a priori threshold for statistical significance was \<0.05.|Repeated Measures General Linear Model|||Test of the effect of guanfacine using a general linear model including a within subjects' effect for treatment (pre- versus post-treatment sessions) and for circuit function, with five repeated measures for each circuit measure defining the cognitive control circuit.||||0.020
72450626|NCT04181736|144421085|OTHER||Cohen's d effect size|1.47|||<|0.001|TWO_SIDED|95.0|0.937|2.002||The a priori threshold for statistical significance was \<0.05.|t-test, 2 sided|||A paired t-test was conducted to evaluate the effect of GIR on changes in HDRS-17 depression scores from pre-treatment to week 2.||2.002|0.937|<0.001
72450627|NCT04181736|144421085|OTHER||Cohen's d effect size|3.152|||<|0.001|TWO_SIDED|95.0|2.757|3.547||The a priori threshold for statistical significance was \<0.05.|t-test, 2 sided|||A paired t-test was conducted to evaluate the effect of GIR on changes in HDRS-17 depression scores from pre-treatment to post-treatment sessions.||3.547|2.757|<0.001
72619706|NCT03733483|144770370|EQUIVALENCE|Maximum likelihood estimates in a repeated measures model were used to assess the effect of insufficient sleep on P1NP levels. Change in P1NP in response to insufficient sleep was assessed using values measured every two hours on two, 24-h profiles obtained at baseline and on night 6 of sleep restriction. Circadian rhythmicity was included in the repeated-measures model as diurnal variation has been documented in prior studies. Data are presented as estimate ± standard error of the estimate.||||||0.53|||||||Mixed Models Analysis|||||||0.53
72619707|NCT03733483|144770371|EQUIVALENCE|Maximum likelihood estimates in a repeated measures model were used to assess the effect of insufficient sleep on CTX levels. Change in CTX in response to insufficient sleep was assessed using values measured every two hours on two, 24-h profiles obtained at baseline and on night 6 of sleep restriction. Circadian rhythmicity was included in the repeated-measures model as diurnal variation has been documented in prior studies. Data are presented as estimate ± standard error of the estimate.||||||0.1|||||||Mixed Models Analysis|||||||0.10
72619708|NCT00472641|144770372|SUPERIORITY_OR_OTHER||||||<|1e-05|||||||Random Regression Mixed Effects Modeling|||||||<0.00001
72619709|NCT00472641|144770373|SUPERIORITY_OR_OTHER||||||<|1e-05|||||||Random Regression Mixed Effects Modeling|||||||<0.00001
72619710|NCT02057666|144770436|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.406||||0.027|TWO_SIDED|95.0|0.182|0.903|||Log Rank|Stratified as per randomisation.|Stratified as per randomisation.|||0.903|0.182|0.027
72619711|NCT02057666|144770437|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.465||||0.448|TWO_SIDED|95.0|0.065|3.355|||Log Rank|||||3.355|0.065|0.448
72619712|NCT02935036|144770467|SUPERIORITY||LS Mean Difference|1.33||||0.5947|TWO_SIDED||||||ANOVA|||||||0.5947
72619713|NCT02935036|144770468|SUPERIORITY||LS Mean Difference|2.75||||0.2912|TWO_SIDED||||||ANOVA|||||||0.2912
72619714|NCT02935036|144770469|SUPERIORITY||Percent difference|2.4||||0.692|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.6920
72450628|NCT04181736|144421086|OTHER||Cohen's d effect size|-1.249|||<|0.001|TWO_SIDED|95.0|-1.724|-0.774||The a priori threshold for statistical significance was \<0.05.|t-test, 2 sided|||A paired t-test was conducted to evaluate the effect of GIR on changes in QIDS-SR depression scores from pre-treatment to post-treatment sessions.||-0.774|-1.724|< 0.001
72619715|NCT06844812|144770470|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|paired t-test||||||<0.001
72450629|NCT04181736|144421087|OTHER||F-statistic|19.362|||<|0.001|TWO_SIDED|||||The a priori threshold for statistical significance was \<0.05.|Repeated Measures General Linear Model|||Test of the effect of guanfacine using a general linear model including a within subjects' effect for treatment (pre- versus post-treatment sessions) and for cognitive control function, with six repeated measures for behavioral tests of cognitive control.||||<0.001
72450630|NCT04181736|144421088|OTHER||Cohen's d effect size|0.881||||0.002|TWO_SIDED|95.0|0.324|1.438||The a priori threshold for statistical significance was \<0.05.|t-test, 2 sided|||A paired t-test was conducted to evaluate the effect of GIR on changes in SWLS scores from pre-treatment to post-treatment sessions.||1.438|0.324|0.002
72619716|NCT06844812|144770471|SUPERIORITY|||||||0.021|||||||t-test, 2 sided|paired t-test||||||0.021
72450631|NCT04181736|144421089|OTHER||F-statistic|11.913||||0.003|TWO_SIDED|||||The a priori threshold for statistical significance was \<0.05.|Repeated Measures General Linear Model|||Test of the effect of guanfacine using a general linear model including a within subjects' effect for treatment (pre- versus post-treatment sessions) and for quality with four repeated measures for domains of quality of life.||||0.003
72619717|NCT06844812|144770472|SUPERIORITY|||||||0.003|||||||t-test, 2 sided|paired t-test||||||0.003
72619718|NCT06844812|144770473|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
72619719|NCT06844812|144770474|SUPERIORITY|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||||||0.001
72391200|NCT03000439|144289776|OTHER||Difference in LS Mean|-0.13|||||TWO_SIDED|95.0|-0.73|0.47||||||DB week 4: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||0.47|-0.73|
72619720|NCT00368849|144770476|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.65||||0.63|||||||ANCOVA|||The primary measures were analyzed as pretreatment and posttreatment difference scores using a series of analyses of covariance controlling for age. The results were screened for model violations (e.g., outliers). Preliminary analyses assured no treatment order effects by examining block by treatment interactions.||||0.63
72619721|NCT00368849|144770477|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.15||||0.09|||||||ANCOVA|||The primary measures were analyzed as pretreatment and posttreatment difference scores using a series of analyses of covariance controlling for age. The results were screened for model violations (e.g., outliers). Preliminary analyses assured no treatment order effects by examining block by treatment interactions.||||0.09
72619722|NCT00368849|144770478|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.26||||0.46|||||||ANCOVA|||The primary measures were analyzed as pretreatment and posttreatment difference scores using a series of analyses of covariance controlling for age. The results were screened for model violations (e.g., outliers). Preliminary analyses assured no treatment order effects by examining block by treatment interactions.||||0.46
72619723|NCT00368849|144770479|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.44||||0.84|||||||ANCOVA|||The secondary measures were analyzed as pretreatment and posttreatment difference scores using a series of analyses of covariance controlling for age. The results were screened for model violations (e.g., outliers). Preliminary analyses assured no treatment order effects by examining block by treatment interactions.||||0.84
72619724|NCT00368849|144770480|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.77||||0.76|||||||ANCOVA|||The secondary measures were analyzed as pretreatment and posttreatment difference scores using a series of analyses of covariance controlling for age. The results were screened for model violations (e.g., outliers). Preliminary analyses assured no treatment order effects by examining block by treatment interactions.||||0.76
72619725|NCT05058456|144770482|OTHER|The primary safety hypothesis is: H0: ΠS \> PGS vs. HA: ΠS ≤ PGS where ΠS is the proportion of patients who experience a MAE within 30 days of procedure and PGS is the Safety Performance Goal. All subjects in whom a Mini S IVL catheter was introduced into the vasculature will be included in the analysis (i.e., it is an intent-to-treat analysis). The hypothesis will be tested using a one-sided Exact Binomial Test at α=0.025.|||||<|0.025|||||||Fisher Exact|||||||<.025
72619726|NCT05058456|144770483|OTHER|The primary effectiveness hypothesis is: H0: ΠE ≤ PGE vs. HA: ΠE \> PGE, where ΠE is the proportion of target lesions with technical success and PG is the effectiveness Performance Goal. One-sided statistical significance level of 0.025 = α. The hypothesis will be tested using a one-sided Exact Binomial Test.|||||<|0.025|||||||Fisher Exact|||||||<.025
72391201|NCT03000439|144289776|OTHER||Difference in LS Mean|0.39|||||TWO_SIDED|95.0|-0.81|1.59||||||DB week 8: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||1.59|-0.81|
72391202|NCT03000439|144289776|OTHER||Difference in LS Mean|0.7|||||TWO_SIDED|95.0|-0.54|1.95||||||DB week 12: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||1.95|-0.54|
72391203|NCT03000439|144289776|OTHER||Difference in LS Mean|-0.4|||||TWO_SIDED|95.0|-0.9|0.1||||||DB week 16: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||0.10|-0.90|
72391204|NCT03000439|144289776|OTHER||Difference in LS Mean|-0.16|||||TWO_SIDED|95.0|-0.46|0.13||||||DB week 20: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||0.13|-0.46|
72391205|NCT03000439|144289776|OTHER||Difference in LS Mean|-0.32|||||TWO_SIDED|95.0|-0.63|-0.01||||||DB week 24: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||-0.01|-0.63|
72391206|NCT03000439|144289776|OTHER||Difference in LS Mean|-1.09|||||TWO_SIDED|95.0|-2.34|0.15||||||DB week 28: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||0.15|-2.34|
72391207|NCT03000439|144289776|OTHER||Difference in LS Mean|0.07|||||TWO_SIDED|95.0|-0.26|0.4||||||DB week 32: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||0.40|-0.26|
72391208|NCT03000439|144289776|OTHER||Difference in LS Mean|-0.02|||||TWO_SIDED|95.0|-0.3|0.26||||||DB week 36: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||0.26|-0.30|
72391209|NCT03000439|144289776|OTHER||Difference in LS Mean|-0.05|||||TWO_SIDED|95.0|-0.53|0.43||||||DB week 40: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||0.43|-0.53|
72391210|NCT03000439|144289776|OTHER||Difference in LS Mean|-0.05|||||TWO_SIDED|95.0|-0.56|0.46||||||DB week 44: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||0.46|-0.56|
72391211|NCT03000439|144289776|OTHER||Difference in LS Mean|-0.03|||||TWO_SIDED|95.0|-0.74|0.69||||||DB week 48: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||0.69|-0.74|
72391212|NCT03000439|144289776|OTHER||Difference in LS Mean|0.2|||||TWO_SIDED|95.0|-0.91|1.32||||||DB week 52: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||1.32|-0.91|
72622434|NCT02181413|144774848|SUPERIORITY||Hazard Ratio (HR)|0.72||||0.002|TWO_SIDED|95.0|0.582|0.89|||Log Rank|P-value was based on log-rank test stratified by pre-induction regimen, International Staging System (ISS) stage and response after transplantation.|HR was based on Cox's proportional hazard regression model stratified by pre-induction regimen, pre-induction ISS stage and response after transplantation. \<1 HR indicates better prevention of progression in Ixazomib arm compared to Placebo.|||0.890|0.582|0.002
72391213|NCT03000439|144289777|OTHER||Difference in LS Mean|1.01|||||TWO_SIDED|95.0|0.09|1.92||||||DB week 4: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open-label baseline value, and Open-label baseline value by visit interaction.||1.92|0.09|
72391214|NCT03000439|144289777|OTHER||Difference in LS Mean|1.31|||||TWO_SIDED|95.0|0.4|2.22||||||DB week 8: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open-label baseline value, and Open-label baseline value by visit interaction.||2.22|0.40|
72391215|NCT03000439|144289777|OTHER||Difference in LS Mean|0.53|||||TWO_SIDED|95.0|-0.47|1.53||||||DB week 12: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open-label baseline value, and Open-label baseline value by visit interaction.||1.53|-0.47|
72391216|NCT03000439|144289777|OTHER||Difference in LS Mean|0.26|||||TWO_SIDED|95.0|-0.63|1.16||||||DB week 16: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open-label baseline value, and Open-label baseline value by visit interaction.||1.16|-0.63|
72391217|NCT03000439|144289777|OTHER||Difference in LS Mean|0.32|||||TWO_SIDED|95.0|-0.33|0.97||||||DB week 20: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open-label baseline value, and Open-label baseline value by visit interaction.||0.97|-0.33|
72391218|NCT03000439|144289777|OTHER||Difference in LS Mean|0.55|||||TWO_SIDED|95.0|-0.1|1.2||||||DB week 24: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open-label baseline value, and Open-label baseline value by visit interaction.||1.20|-0.10|
72391219|NCT03000439|144289777|OTHER||Difference in LS Mean|0.2|||||TWO_SIDED|95.0|-0.93|1.33||||||DB week 28: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open-label baseline value, and Open-label baseline value by visit interaction.||1.33|-0.93|
72391220|NCT03000439|144289777|OTHER||Difference in LS Mean|0.62|||||TWO_SIDED|95.0|-0.17|1.42||||||DB week 32: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open-label baseline value, and Open-label baseline value by visit interaction.||1.42|-0.17|
72391221|NCT03000439|144289777|OTHER||Difference in LS Mean|0.48|||||TWO_SIDED|95.0|-0.02|0.98||||||DB week 36: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open-label baseline value, and Open-label baseline value by visit interaction.||0.98|-0.02|
72619727|NCT04392362|144770491|NON_INFERIORITY|The non-inferiority margin or delta was calculated as -0.12(-12%)|Risk Ratio (RR)|0.89||||0.8982|ONE_SIDED|95.0||||0.05 was the level of significance|Wilcoxon (Mann-Whitney)|||The null hypothesis is that the AHA method is inferior to the SIM method but not lower than a pre calculated noninferiority delta of -0.12 (-12 %) and a 95% one sided confidence interval. Only 33 (instead of 151 for a power of 95%) patients could be enrolled with 25 in the SIM and 8 in the AHA arms, which resulted in an estimated power test of 59.08%.||||0.8982
72619728|NCT01428713|144770492|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|536.4|STANDARD_ERROR_OF_MEAN|162.12||0.01||||||P value \< 0.05 is considered significant in this study|Mixed Models Analysis||Comparing PBAC score value at baseline vs. end of 3 cycles for TA|||||0.01
72619729|NCT01428713|144770492|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|430.6|STANDARD_ERROR_OF_MEAN|157.35||0.03||||||P value \< 0.05 is considered significant for this study|Mixed Models Analysis||Comparing PBAC score value at baseline vs. end of 3 cycles for COCP|||||0.03
72619730|NCT01428713|144770492|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|15.6|STANDARD_ERROR_OF_MEAN|5.08||0.03||||||P value \< 0.05 is considered significant for this study|Mixed Models Analysis||Comparing Peds QL score value at baseline vs. end of 3 cycles for TA|||||0.03
72619731|NCT01428713|144770492|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.75|STANDARD_ERROR_OF_MEAN|4.87||0.01|||||||Mixed Models Analysis||Comparing Peds QL score value at baseline vs. end of 3 cycles for COCP|||||0.01
72450632|NCT04181736|144421090|OTHER||Cohen's d effect size|-0.2||||0.283|TWO_SIDED|95.0|-0.608|0.208||The a priori threshold for statistical significance was \<0.05.|t-test, 2 sided|||A paired t-test was conducted to evaluate the effect of GIR on changes in C-SSRS scores from pre-treatment to post-treatment sessions.||0.208|-0.608|0.283
72450633|NCT02518048|144421103|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.17|||<|0.001|TWO_SIDED|95.0|-2.58|-1.76||Least Square Means difference from ANOVA with treatment group as fixed effect and subject as random effect (105 treated sites per treatment group).|ANOVA|||A last observation carried forward (LOCF) approach was used to account for drop-outs and missing values in the analysis of end of treatment values.||-1.76|-2.58|<0.001
72450634|NCT02518048|144421106|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.42|||<|0.001|TWO_SIDED|95.0|-0.53|-0.32||Least Square Means difference from ANOVA with treatment group as fixed effect and subject as random effect (105 treated sites per treatment group)|ANOVA|||Total Skin Thickness: LEO 90100 vs. Betesil®||-0.32|-0.53|<0.001
72450635|NCT02518048|144421106|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.55|||<|0.001|TWO_SIDED|95.0|-0.69|-0.41||Least Square Means difference from ANOVA with treatment group as fixed effect and subject as random effect (105 treated sites per treatment group)|ANOVA|||Echo-Poor Band Thickness: LEO 90100 vs. Betesil®||-0.41|-0.69|<0.001
72450636|NCT04505410|144421107|OTHER|||||||0.05|||||||Mixed Models Analysis|||||||0.05
72450637|NCT01586910|144421110|NON_INFERIORITY|Non-inferiority margin was 0.07. Posterior threshold for non-inferiority was 0.971|Posterior Median of the Difference|-1.4|||||TWO_SIDED|||||The posterior probability of non-inferiority is \> 0.9999. The posterior probability is the probability of the event rate by updating the prior probability distribution with observed data using Bayes' Theorem.|Bayesian||95% Bayesian credible interval for the difference (TAVR-SAVR) was (-5.2%, 2.3%). The 95% credible interval is the 2.5th and 97.5th percentiles of the posterior distribution.|Primary Hypothesis: TAVR with the Medtronic TAVR is non-inferior to SAVR for all-cause mortality or disabling stroke rate during a fixed follow-up of 24 months.||||
72450638|NCT02278211|144421213|OTHER||Hazard Ratio (HR)|1.25||||0.2|TWO_SIDED|95.0|0.89|1.76|||Log Rank|||||1.76|0.89|0.20
72450639|NCT02278211|144421214|OTHER||Hazard Ratio (HR)|2.43||||0.02|TWO_SIDED|95.0|1.15|5.12|||Log Rank|||||5.12|1.15|0.02
72619732|NCT01052428|144770495|SUPERIORITY_OR_OTHER|||||||0.4568||95.0|||||Mixed Models Analysis|||The differences in the rate of progression of the outcome measures were the focus of the comparisons over time between the treatment groups. A significant interaction effect between time and treatment group in the mixed model is the measure of treatment effect. Since some visits did not occur at the scheduled 6 month intervals, the results have been divided into 3-month visit intervals for reporting purposes and the number of Participants for each interval is indicated as (n=x,y)||||0.4568
72619733|NCT01052428|144770496|SUPERIORITY_OR_OTHER|||||||0.1967||95.0||||not adjusted for multiple comparisons|Mixed Models Analysis|||The differences in the rate of progression of the outcome measures were the focus of the comparisons over time between the treatment groups. A significant interaction effect between time and treatment group in the mixed model is the measure of treatment effect. Since some visits did not occur at the scheduled 6 month intervals, the results have been divided into 3-month visit intervals for reporting purposes and the number of Participants for each interval is indicated as (n=x,y)||||0.1967
72619734|NCT01052428|144770497|SUPERIORITY_OR_OTHER|||||||0.55||95.0||||not adjusted for multiple comparisons|Mixed Models Analysis|||The differences in the rate of progression of the outcome measures were the focus of the comparisons over time between the treatment groups. A significant interaction effect between time and treatment group in the mixed model is the measure of treatment effect. Since some visits did not occur at the scheduled 6 month intervals, the results have been divided into 3-month visit intervals for reporting purposes and the number of Participants for each interval is indicated as (n=x,y)||||0.55
72619735|NCT01052428|144770498|SUPERIORITY_OR_OTHER|||||||0.21||95.0||||not adjusted for multiple comparisons|Mixed Models Analysis|||The differences in the rate of progression of the outcome measures were the focus of the comparisons over time between the treatment groups. A significant interaction effect between time and treatment group in the mixed model is the measure of treatment effect. Since some visits did not occur at the scheduled 6 month intervals, the results have been divided into 3-month visit intervals for reporting purposes and the number of Participants for each interval is indicated as (n=x,y)||||0.21
72391222|NCT03000439|144289777|OTHER||Difference in LS Mean|0.64|||||TWO_SIDED|95.0|-0.3|1.58||||||DB week 40: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open-label baseline value, and Open-label baseline value by visit interaction.||1.58|-0.30|
72391223|NCT03000439|144289777|OTHER||Difference in LS Mean|0.23|||||TWO_SIDED|95.0|-0.4|0.85||||||DB week 44: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open-label baseline value, and Open-label baseline value by visit interaction.||0.85|-0.40|
72391224|NCT03000439|144289777|OTHER||Difference in LS Mean|0.26|||||TWO_SIDED|95.0|-0.36|0.88||||||DB week 48: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open-label baseline value, and Open-label baseline value by visit interaction.||0.88|-0.36|
72391225|NCT03000439|144289777|OTHER||Difference in LS Mean|0.11|||||TWO_SIDED|95.0|-0.87|1.09||||||DB week 52: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open-label baseline value, and Open-label baseline value by visit interaction.||1.09|-0.87|
72450640|NCT05970861|144421243|OTHER||||||<|0.05|TWO_SIDED|95.0|||||t-test, 2 sided|||"Null hypothesis: there is no statistical significance between the mean percentages of microbiota units of the main and control groups after the mare's milk administration.~Alternate hypothesis: statistical significance exists between the mean percentages of microbiota units of the main and control groups after the mare's milk administration."||||<0.05
72450641|NCT05970861|144421243|OTHER||||||<|0.05|||||||ANOVA|||"Null Hypothesis: The freeze-dried mare's milk does not significantly influence the mean percentages of gut microbiota units.~Alternate Hypothesis: The freeze-dried mare's milk significantly influences the mean percentages of gut microbiota units."||||<0.05
72498966|NCT00348140|144528172|SUPERIORITY||Mean Difference (Net)|1.7||||0.039|TWO_SIDED|95.0|0.1|3.4|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|For Week 24||3.4|0.1|0.039
72498967|NCT00348140|144528172|SUPERIORITY||Mean Difference (Net)|-0.1||||0.895|TWO_SIDED|95.0|-1.8|1.6|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|For Week 24||1.6|-1.8|0.895
72498968|NCT00348140|144528172|SUPERIORITY||Mean Difference (Net)|0.1||||0.914|TWO_SIDED|95.0|-2.1|2.3|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|For Week 48||2.3|-2.1|0.914
72498969|NCT00348140|144528172|SUPERIORITY||Mean Difference (Net)|-0.9||||0.43|TWO_SIDED|95.0|-3.2|1.3|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|For Week 48||1.3|-3.2|0.430
72498970|NCT00348140|144528173|SUPERIORITY||Mean Difference (Net)|-0.2||||0.583|TWO_SIDED|95.0|-1.1|0.6|||Mixed model for repeated measures|||For Week 8||0.6|-1.1|0.583
72498971|NCT00348140|144528173|SUPERIORITY||Mean Difference (Net)|-0.2||||0.631|TWO_SIDED|95.0|-1.1|0.6|||Mixed model for repeated measures|||For Week 8||0.6|-1.1|0.631
72391226|NCT03000439|144289778|OTHER||Difference in LS Mean|-0.05|||||TWO_SIDED|95.0|-0.77|0.67||||||DB week 4: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||0.67|-0.77|
72450642|NCT05970861|144421244|OTHER||||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||"Null hypothesis: No statistically significant difference exists between antiphospholipid antibody levels before and after the mare's milk administration.~Alternate hypothesis: Statistically significant difference exists between antiphospholipid antibody levels before and after the mare's milk administration."||||>0.05
72450643|NCT05970861|144421245|OTHER|||||||0.01|||||||Wilcoxon (Mann-Whitney)|||"Null hypothesis: No statistically significant difference exists between uric acid blood levels before and after the mare's milk administration.~Alternate hypothesis: Statistically significant difference exists between uric acid blood levels before and after the mare's milk administration."||||0.01
72498972|NCT00348140|144528173|SUPERIORITY||Mean Difference (Net)|0.1||||0.812|TWO_SIDED|95.0|-0.8|1.1|||Mixed model for repeated measures|||For Week 16||1.1|-0.8|0.812
72498973|NCT00348140|144528173|SUPERIORITY||Mean Difference (Net)|0.0||||0.952|TWO_SIDED|95.0|-0.9|1.0|||Mixed model for repeated measures|||For Week 16||1.0|-0.9|0.952
72498974|NCT00348140|144528173|SUPERIORITY||Mean Difference (Net)|-0.9||||0.117|TWO_SIDED|95.0|-2.1|0.2|||Mixed model for repeated measures|||For Week 24||0.2|-2.1|0.117
72498975|NCT00348140|144528173|SUPERIORITY||Mean Difference (Net)|-1.0||||0.074|TWO_SIDED|95.0|-2.1|0.1|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|For Week 24||0.1|-2.1|0.074
72498976|NCT00348140|144528173|SUPERIORITY||Mean Difference (Net)|-1.0||||0.141|TWO_SIDED|95.0|-2.4|0.3|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|For Week 48||0.3|-2.4|0.141
72391227|NCT03000439|144289778|OTHER||Difference in LS Mean|0.58|||||TWO_SIDED|95.0|-0.37|1.53||||||DB week 8: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||1.53|-0.37|
72391228|NCT03000439|144289778|OTHER||Difference in LS Mean|0.12|||||TWO_SIDED|95.0|-1.06|1.3||||||DB week 12: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||1.30|-1.06|
72619736|NCT01052428|144770499|SUPERIORITY_OR_OTHER|||||||0.006||95.0||||not adjusted for multiple comparisons|Mixed Models Analysis|||The differences in the rate of progression of the outcome measures were the focus of the comparisons over time between the treatment groups. A significant interaction effect between time and treatment group in the mixed model is the measure of treatment effect. Since some visits did not occur at the scheduled 6 month intervals, the results have been divided into 3-month visit intervals for reporting purposes and the number of Participants for each interval is indicated as (n=x,y)||||0.006
72619737|NCT01052428|144770500|SUPERIORITY_OR_OTHER|||||||0.16||95.0||||not adjusted for multiple comparisons|Mixed Models Analysis|||The differences in the rate of progression of the outcome measures were the focus of the comparisons over time between the treatment groups. A significant interaction effect between time and treatment group in the mixed model is the measure of treatment effect. Since some visits did not occur at the scheduled 6 month intervals, the results have been divided into 3-month visit intervals for reporting purposes and the number of Participants for each interval is indicated as (n=x,y)||||0.16
72619738|NCT01052428|144770501|SUPERIORITY_OR_OTHER|||||||0.001||95.0||||not adjusted for multiple comparisons|Mixed Models Analysis|||The differences in the rate of progression of the outcome measures were the focus of the comparisons over time between the treatment groups. A significant interaction effect between time and treatment group in the mixed model is the measure of treatment effect. Since some visits did not occur at the scheduled 6 month intervals, the results have been divided into 3-month visit intervals for reporting purposes and the number of Participants for each interval is indicated as (n=x,y)||||0.001
72619739|NCT00871000|144770504|NON_INFERIORITY|Criterion for evaluation of Non-inferiority: UL of the standardised asymptotic 95% CI on the group difference \[Tetravac Group minus Boostrix Polio Group\] in the percentage of subjects with anti-polio type 1 antibody titers ≥ 8 was ≤ 10%.|Difference in seroprotection rate|0.0|||||TWO_SIDED|95.0|-2.61|2.7||||||To demonstrate that GSK Biologicals' Boostrix Polio™ vaccine is non-inferior to Sanofi-Pasteur-MSD's Tetravac™ vaccine, in terms of seroprotection rates against poliovirus type 1, one month after vaccination.||2.7|-2.61|
72619740|NCT00871000|144770504|NON_INFERIORITY|Criterion for evaluation of Non-inferiority: UL of the standardised asymptotic 95% CI on the group difference \[Tetravac Group minus Boostrix Polio Group\] in the percentage of subjects with anti-polio type 2 antibody titers ≥ 8 was ≤ 10%.|Difference in seroprotection rate|0.0|||||TWO_SIDED|95.0|-2.61|2.7||||||To demonstrate that GSK Biologicals' Boostrix Polio™ vaccine is non-inferior to Sanofi-Pasteur-MSD's Tetravac™ vaccine, in terms of seroprotection rates against polio type 2, one month after vaccination.||2.7|-2.61|
72619741|NCT00871000|144770504|NON_INFERIORITY|Criterion for evaluation of Non-inferiority: UL of the standardised asymptotic 95% CI on the group difference \[Tetravac Group minus Boostrix Polio Group\] in the percentage of subjects with anti-polio type 3 antibody titers ≥ 8 was ≤ 10%.|Difference in seroprotection rate|0.0|||||TWO_SIDED|95.0|-2.61|2.72||||||To demonstrate that GSK Biologicals' Boostrix Polio™ vaccine is non-inferior to Sanofi-Pasteur-MSD's Tetravac™ vaccine, in terms of seroprotection rates against polio type 3, one month after vaccination.||2.72|-2.61|
72619742|NCT00871000|144770505|NON_INFERIORITY|Criterion for evaluation of Non-inferiority: Upper limit (UL) of the standardised asymptotic 95% confidence interval (CI) on the group difference \[Tetravac Group minus Boostrix Polio Group\] in the percentage of subjects with anti-D antibody concentrations ≥ 0.1 IU/mL was lower than or equal to (≤) 10%.|Difference in seroprotection rate|0.0|||||TWO_SIDED|95.0|-2.61|2.7||||||To demonstrate that GSK Biologicals' Boostrix Polio™ vaccine is non-inferior to Sanofi-Pasteur-MSD's Tetravac™ vaccine, in terms of seroprotection rates against diphtheria, one month after vaccination.||2.7|-2.61|
72619743|NCT00871000|144770505|NON_INFERIORITY|Criterion for evaluation of Non-inferiority: UL of the standardised asymptotic 95% CI on the group difference \[Tetravac Group minus Boostrix Polio Group\] in the percentage of subjects with anti-T antibody concentrations ≥ 0.1 IU/mL was ≤ 10%.|Difference in seroprotection rate|0.0|||||TWO_SIDED|95.0|-2.61|2.7||||||To demonstrate that GSK Biologicals' Boostrix Polio™ vaccine is non-inferior to Sanofi-Pasteur-MSD's Tetravac™ vaccine, in terms of seroprotection rates against tetanus, one month after vaccination.||2.7|-2.61|
72619744|NCT01791205|144770577|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|3.538||||0.1194|TWO_SIDED|95.0|0.65|19.33||The relation between retention rate and duration of disease for phase II was estimated with the Cox regression model.|Regression, Cox|||The relation between retention rate and DAS28 (\<2.6 vs \<3.2) was assayed with the Cox regression.||19.33|0.65|0.1194
72619745|NCT01791205|144770578|SUPERIORITY_OR_OTHER|||||||0.3895|||||||Regression, Cox|||||||0.3895
72619746|NCT01791205|144770579|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.211||||0.49|TWO_SIDED|95.0|0.703|2.086|||Regression, Logistic|||||2.086|0.703|0.4900
72619747|NCT01791205|144770580|SUPERIORITY_OR_OTHER||Delta|-0.042||||0.6908|TWO_SIDED|95.0|-0.251|0.167|||t-test, 2 sided|||||0.167|-0.251|0.6908
72619748|NCT01791205|144770581|SUPERIORITY_OR_OTHER|||||||0.021|||||||Pearson's chi-squared test|||||||0.0210
72619749|NCT02191397|144770618|NON_INFERIORITY|A one-sided 97.5% confidence interval for the between-treatment difference (bupropion XL-escitalopram) was compared with the pre-defined non-inferiority margin of 2.2. If the upper limit of the one-sided 97.5% confidence interval was below 2.2, then it indicated that bupropion was not inferior in efficacy to escitalopram.|Mean Difference (Final Values)|0.8||||0.139|TWO_SIDED|95.0|-0.27|1.94||Analysis included Baseline HAMD-17 total score as covariate, treatment, gender, visit and treatment-visit interaction as fixed effects. Unstructured covariance matrix was used.|Mixed model repeated measures analysis||Observed Cases (OC) dataset was used, where available data at a given time point was used with no missing values filled in with estimates.|||1.94|-0.27|0.139
72619750|NCT02191397|144770619|OTHER||Odds Ratio (OR)|0.85||||0.479|TWO_SIDED|95.0|0.55|1.33||P-value was estimated from a Generalized Estimating Equation (GEE) model with Response based on HADM-17 as response variable and treatment, gender as explanatory variables.|GEE model|||||1.33|0.55|0.479
72619751|NCT02191397|144770620|OTHER||Odds Ratio (OR)|0.73||||0.129|TWO_SIDED|95.0|0.48|1.1||P-value was estimated from a Generalized Estimating Equation (GEE) model with Response based on HADM-17 as response variable and treatment, gender as explanatory variables|GEE model|||||1.10|0.48|0.129
72619752|NCT02191397|144770621|OTHER||Odds Ratio (OR)|0.83||||0.354|TWO_SIDED|95.0|0.55|1.24||P-value was estimated from a GEE model with Response based on HADM-17 as response variable and treatment, gender as explanatory variables|GEE model|||||1.24|0.55|0.354
72619753|NCT02191397|144770622|OTHER||Odds Ratio (OR)|0.85||||0.489|TWO_SIDED|95.0|0.54|1.34||P-value was estimated from a GEE model with Response based on HADM-17 as response variable and treatment, gender as explanatory variables|GEE model|||||1.34|0.54|0.489
72619754|NCT02191397|144770623|OTHER||Mean Difference (Final Values)|0.2||||0.627|TWO_SIDED|95.0|-0.7|1.16||Analysis included Baseline MADRS total score as covariate, treatment, gender, visit and treatment-visit interaction as fixed effects. Unstructured covariance matrix was used.|Mixed model repeated measures analysis||Week 1. OC dataset was used, where available data at a given time point was used with no missing values filled in with estimates.|||1.16|-0.70|0.627
72619755|NCT02191397|144770623|OTHER||Mean Difference (Final Values)|1.4||||0.037|TWO_SIDED|95.0|0.08|2.66||Analysis included Baseline MADRS total score as covariate, treatment, gender, visit and treatment-visit interaction as fixed effects. Unstructured covariance matrix was used.|Mixed model repeated measures analysis||Week 2. OC dataset was used, where available data at a given time point was used with no missing values filled in with estimates.|||2.66|0.08|0.037
72619756|NCT02191397|144770623|OTHER||Mean Difference (Final Values)|1.2||||0.143|TWO_SIDED|95.0|-0.4|2.78||Analysis included Baseline MADRS total score as covariate, treatment, gender, visit and treatment-visit interaction as fixed effects. Unstructured covariance matrix was used.|Mixed model repeated measures analysis||Week 4. OC dataset was used, where available data at a given time point was used with no missing values filled in with estimates.|||2.78|-0.40|0.143
72619757|NCT02191397|144770623|OTHER||Mean Difference (Final Values)|0.8||||0.33|TWO_SIDED|95.0|-0.81|2.4||Analysis included Baseline MADRS total score as covariate, treatment, gender, visit and treatment-visit interaction as fixed effects. Unstructured covariance matrix was used.|Mixed model repeated measures analysis||Week 6. OC dataset was used, where available data at a given time point was used with no missing values filled in with estimates.|||2.40|-0.81|0.330
72391229|NCT03000439|144289778|OTHER||Difference in LS Mean|-0.26|||||TWO_SIDED|95.0|-1.27|0.74||||||DB week 16: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||0.74|-1.27|
72391230|NCT03000439|144289778|OTHER||Difference in LS Mean|-0.16|||||TWO_SIDED|95.0|-0.83|0.52||||||DB week 20: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||0.52|-0.83|
72391231|NCT03000439|144289778|OTHER||Difference in LS Mean|0.05|||||TWO_SIDED|95.0|-0.61|0.71||||||DB week 24: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||0.71|-0.61|
72391232|NCT03000439|144289778|OTHER||Difference in LS Mean|-0.1|||||TWO_SIDED|95.0|-1.45|1.25||||||DB week 28: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||1.25|-1.45|
72450644|NCT05970861|144421246|OTHER||||||<|0.01|||||||t-test, 2 sided|||"Null hypothesis: No statistically significant difference exists between the scores on a scale (PCS, MCS) after the mare's milk administration.~Alternate hypothesis: Statistically significant difference exists between the scores on a scale (PCS, MCS) after the mare's milk administration."||||<0.01
72450645|NCT05970861|144421246|OTHER||||||>|0.05|||||||t-test, 2 sided|||"Null hypothesis: No statistically significant difference exists between the scores on a scale (PCS, MCS) after 2 measurements in the control group.~Alternate hypothesis: Statistically significant difference exists between the scores on a scale (PCS, MCS) after 2 measurements in the control group."||||>0.05
72450646|NCT05970861|144421246|OTHER||||||<|0.01|||||||ANOVA|||"Null Hypothesis: The freeze-dried mare's milk does not significantly influence the scores on the scales (PCS, MCS).~Alternate Hypothesis: The freeze-dried mare's milk significantly influences the scores on the scales (PCS, MCS)."||||<0.01
72450647|NCT03988621|144421256|SUPERIORITY||Mean Difference (Net)|-0.65||||0.04|TWO_SIDED|95.0|-1.27|-0.03||The p-value for the group-by-time interaction is presented, as well as the estimated mean and confidence interval for difference in 6-month change between intervention and treatment groups.|Mixed Models Analysis||Mean HSCN scale scores of participants in the intervention group were estimated to decrease by 0.65 (95% CI: -1.27 to -0.03) units more than that of participants in the control group from baseline to 6-months.|||-0.03|-1.27|0.04
72619758|NCT02191397|144770623|OTHER||Mean Difference (Final Values)|0.9||||0.278|TWO_SIDED|95.0|-0.69|2.4||Analysis included Baseline MADRS total score as covariate, treatment, gender, visit and treatment-visit interaction as fixed effects. Unstructured covariance matrix was used.|Mixed model repeated measures analysis||Week 8. OC dataset was used, where available data at a given time point was used with no missing values filled in with estimates.|||2.40|-0.69|0.278
72619759|NCT02191397|144770624|OTHER||Mean Difference (Final Values)|0.0||||0.579|TWO_SIDED|95.0|-0.09|0.16||Analysis included Baseline HAMD-17 depressed mood subscale score as covariate, treatment, gender, visit and treatment-visit interaction as fixed effects. Unstructured covariance matrix was used.|Mixed model repeated measures analysis||Comparison for Week 1. OC dataset was used, where available data at a given time point was used with no missing values filled in with estimates.|||0.16|-0.09|0.579
72450648|NCT03988621|144421257|SUPERIORITY||Mean Difference (Net)|5.05||||0.01|TWO_SIDED|95.0|1.12|8.98||The p-value for the group-by-time interaction is presented, as well as the estimated mean and confidence interval for difference in 6-month change between intervention and treatment groups.|Mixed Models Analysis||Mean Self Care Inventory scale scores of participants in the intervention group were estimated to increase by 5.05 (95% CI: 1.12 to 8.98) units more than that of participants in the control group from baseline to 6-months.|||8.98|1.12|0.01
72391233|NCT03000439|144289778|OTHER||Difference in LS Mean|0.31|||||TWO_SIDED|95.0|-0.61|1.23||||||DB week 32: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||1.23|-0.61|
72391234|NCT03000439|144289778|OTHER||Difference in LS Mean|0.18|||||TWO_SIDED|95.0|-0.34|0.71||||||DB week 36: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||0.71|-0.34|
72391235|NCT03000439|144289778|OTHER||Difference in LS Mean|0.36|||||TWO_SIDED|95.0|-0.74|1.46||||||DB week 40: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||1.46|-0.74|
72391236|NCT03000439|144289778|OTHER||Difference in LS Mean|-0.09|||||TWO_SIDED|95.0|-0.75|0.56||||||DB week 44: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||0.56|-0.75|
72391237|NCT03000439|144289778|OTHER||Difference in LS Mean|0.06|||||TWO_SIDED|95.0|-0.68|0.81||||||DB week 48: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||0.81|-0.68|
72391238|NCT03000439|144289778|OTHER||Difference in LS Mean|-0.08|||||TWO_SIDED|95.0|-1.1|0.94||||||DB week 52: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||0.94|-1.10|
72391239|NCT03000439|144289779|OTHER||Difference in LS Mean|-1.46|||||TWO_SIDED|95.0|-14.59|11.66||||||DB week 4: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open label baseline value, and Open-label baseline value by visit interaction.||11.66|-14.59|
72391240|NCT03000439|144289779|OTHER||Difference in LS Mean|-7.22|||||TWO_SIDED|95.0|-19.62|5.17||||||DB week 8: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open label baseline value, and Open-label baseline value by visit interaction.||5.17|-19.62|
72391241|NCT03000439|144289779|OTHER||Difference in LS Mean|-6.61|||||TWO_SIDED|95.0|-19.36|6.14||||||DB week 12: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open label baseline value, and Open-label baseline value by visit interaction.||6.14|-19.36|
72391242|NCT03000439|144289779|OTHER||Difference in LS Mean|-8.5|||||TWO_SIDED|95.0|-20.28|3.27||||||DB week 16: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open label baseline value, and Open-label baseline value by visit interaction.||3.27|-20.28|
72450649|NCT03988621|144421258|SUPERIORITY||Mean Difference (Net)|-4.5|||<|0.0001|TWO_SIDED|95.0|-6.48|-2.52||The p-value for the group-by-time interaction is presented, as well as the estimated mean and confidence interval for difference in 6-month change between intervention and treatment groups.|Mixed Models Analysis||Mean PSS scale scores of participants in the intervention group were estimated to decrease by 4.50 (95% CI: -6.48 to -2.52) units more than that of participants in the control group from baseline to 6-months.|||-2.52|-6.48|<0.0001
72450650|NCT03988621|144421259|SUPERIORITY||Mean Difference (Net)|2.16||||0.099|TWO_SIDED|95.0|-0.41|4.73||The p-value for the group-by-time interaction is presented, as well as the estimated mean and confidence interval for difference in 6-month change between intervention and treatment groups.|Mixed Models Analysis|||Active Coping Subscale||4.73|-0.41|0.099
72450651|NCT03988621|144421259|SUPERIORITY||Mean Difference (Net)|-0.88||||0.25|TWO_SIDED|95.0|-2.38|0.62||The p-value for the group-by-time interaction is presented, as well as the estimated mean and confidence interval for difference in 6-month change between intervention and treatment groups.|Mixed Models Analysis||Estimated difference may not be consistent with difference sample means presented in outcome measure data table.|Avoidance Coping Subscale||0.62|-2.38|0.25
72561908|NCT03259789|144654659|SUPERIORITY||Difference of LS Means|-0.53|||<|0.0001|TWO_SIDED|95.0|-0.74|-0.32||P-value is presented based on one-sided statistical tests using a 0.025 level of significance|Mixed-effects repeated measures|Mixed-effects repeated measures analysis includes country, treatment, visit, treatment and baseline HbA1c value as fixed effect covariates||Model-adjusted change from baseline at week 24 was calculated as the difference in LS Mean between bexagliflozin group and placebo group.||-0.32|-0.74|< 0.0001
72561909|NCT02063217|144654661|SUPERIORITY|Mixed linear models|Mean Difference (Net)|17.0||||0.07|TWO_SIDED|||||Bonferroni correction was used for multiple comparisons.|Mixed Models Analysis||Mean (standard error), units = %. 17(7.2) increase in overnight amyloid-beta 40 concentrations over waking baseline between the sleep deprivation group and controls.|Mixed linear modeling of change in overnight amyloid beta concentrations from waking baseline between 01:00 and 11:00. Data provided for amyloid beta-40.||||0.07
72619760|NCT02191397|144770624|OTHER||Mean Difference (Final Values)|0.1||||0.163|TWO_SIDED|95.0|-0.04|0.26||Analysis included Baseline HAMD-17 depressed mood subscale score as covariate, treatment, gender, visit and treatment-visit interaction as fixed effects. Unstructured covariance matrix was used.|Mixed model repeated measures analysis||Comparison for Week 2. OC dataset was used, where available data at a given time point was used with no missing values filled in with estimates.|||0.26|-0.04|0.163
72391243|NCT03000439|144289779|OTHER||Difference in LS Mean|-3.95|||||TWO_SIDED|95.0|-10.53|2.62||||||DB week 20: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open label baseline value, and Open-label baseline value by visit interaction.||2.62|-10.53|
72561910|NCT02063217|144654661|SUPERIORITY|Mixed linear models|Mean Difference (Net)|7.0||||1|TWO_SIDED|||||Bonferroni correction was used for multiple comparisons.|Mixed Models Analysis||Mean= 7%, standard error = 7.6%. 7% increase in overnight amyloid beta 40 concentrations over the waking baseline between the sleep induction group and control group.|Mixed linear modeling of change in overnight amyloid beta concentrations from waking baseline between 01:00 and 11:00. Data provided for amyloid beta-40.||||1.0
72561911|NCT02416934|144654662|SUPERIORITY||Mean Difference (Final Values)|-1.5392|STANDARD_ERROR_OF_MEAN|0.7176||0.036|TWO_SIDED|95.0|-2.9761|-0.1022|||t-test, 2 sided|||Comparing DSQ between Dexamethasone and Saline at Day 1 post-op||-.1022|-2.9761|0.036
72391244|NCT03000439|144289779|OTHER||Difference in LS Mean|-1.44|||||TWO_SIDED|95.0|-8.09|5.21||||||DB week 24: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open label baseline value, and Open-label baseline value by visit interaction.||5.21|-8.09|
72391245|NCT03000439|144289779|OTHER||Difference in LS Mean|-4.32|||||TWO_SIDED|95.0|-16.67|8.03||||||DB week 28: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open label baseline value, and Open-label baseline value by visit interaction.||8.03|-16.67|
72391246|NCT03000439|144289779|OTHER||Difference in LS Mean|-2.86|||||TWO_SIDED|95.0|-13.97|8.25||||||DB week 32: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open label baseline value, and Open-label baseline value by visit interaction.||8.25|-13.97|
72391247|NCT03000439|144289779|OTHER||Difference in LS Mean|-10.95|||||TWO_SIDED|95.0|-24.63|2.73||||||DB week 36: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open label baseline value, and Open-label baseline value by visit interaction.||2.73|-24.63|
72450652|NCT03988621|144421259|SUPERIORITY|The p-value for the group-by-time interaction is presented, as well as the estimated mean and confidence interval for difference in 6-month change between intervention and treatment groups.|Mean Difference (Net)|-0.31||||0.68|TWO_SIDED|95.0|-1.81|1.18|||Mixed Models Analysis|||Minimization Coping Subscale||1.18|-1.81|0.68
72450653|NCT03988621|144421260|SUPERIORITY||Mean Difference (Net)|-1.32||||0.27|TWO_SIDED|95.0|-3.68|1.04||The p-value for the group-by-time interaction is presented, as well as the estimated mean and confidence interval for difference in 6-month change between intervention and treatment groups.|Mixed Models Analysis|||Physical Health Score||1.04|-3.68|0.27
72450654|NCT03988621|144421260|SUPERIORITY||Mean Difference (Net)|3.35||||0.04|TWO_SIDED|95.0|0.17|6.53||The p-value for the group-by-time interaction is presented, as well as the estimated mean and confidence interval for difference in 6-month change between intervention and treatment groups.|Mixed Models Analysis||Mean Mental Health scores of participants in the intervention group were estimated to increase by 3.35 (95% CI: 0.17 to 6.53) units more than that of participants in the control group from baseline to 6-months.|Mental Health Score||6.53|0.17|0.04
72450655|NCT03988621|144421263|SUPERIORITY||Mean Difference (Final Values)|1.3472||||0.5433|TWO_SIDED|95.0|0.5153|3.5218|||Regression, zero inflated poisson||Estimation accounts for the zero-inflated distribution of hospitalization count, thus estimate is inconsistent with mean values in the Outcome Measure Data table|||3.5218|0.5153|0.5433
72450656|NCT03988621|144421264|SUPERIORITY||Mean Difference (Final Values)|1.0143||||0.9173|TWO_SIDED|95.0|0.7766|1.3247|||Zero-inflated poisson regression|||||1.3247|0.7766|0.9173
72450657|NCT03988621|144421265|SUPERIORITY|||||||0.6486|||||||Fisher Exact|||||||0.6486
72450658|NCT03988621|144421266|SUPERIORITY|||||||0.6791|||||||t-test, 2 sided|||||||0.6791
72450659|NCT04778410|144421287|SUPERIORITY|||||||0.1794|||||||One Group Chi-Square test|The p-value was based on one group Chi-Square test for the null hypothesis CR rate was 0.19 at one-sided alpha of 0.1 in Cohort 2.||||||0.1794
72450660|NCT00677365|144421328|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.96||||0.0014|TWO_SIDED|95.0|-1.54|-0.38||Repeated Measure Model|Mixed Models Analysis|||LS Mean Difference||-0.38|-1.54|0.0014
72450661|NCT00677365|144421329|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.21||||0.0007|TWO_SIDED|95.0|0.09|0.52|||Regression, Cox|||Hazard Ratio for need of anti-pseudomonal antimicrobials; Estimates are obtained from a Cox proportional hazards regression model including terms for treatment, region, baseline P.aeruginosa density (log10 ), highest baseline MIC of levofloxacin against P. aeruginosa (log2 ), and baseline percent predicted FEV1 (quartiles)||0.52|0.09|0.0007
72450662|NCT00677365|144421330|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|8.61||||0.0026|TWO_SIDED|95.0|3.05|14.17|||Mixed Models Analysis|||LS Mean Difference Between MP-376 240 mg and Placebo groups||14.17|3.05|0.0026
72450663|NCT00677365|144421331|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|10.94||||0.0008|TWO_SIDED|95.0|4.63|17.25|||Mixed Models Analysis|||LS Mean Difference Between Placebo and MP-376 240 mg BID groups||17.25|4.63|0.0008
72450664|NCT00677365|144421332|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.5||||0.2174|TWO_SIDED|95.0|-2.68|11.67|||Mixed Models Analysis|||LS Mean Difference from MP-376 240 mg BID to placebo groups||11.67|-2.68|0.2174
72450665|NCT02542631|144421376|NON_INFERIORITY|The sample size determination was based on the primary endpoint, A1C change from Baseline to Week 24. Assuming that the true mean difference in A1C change for Finesse versus Pen was -0.1% with a SD of 1.2%, a study population of 250 completers (125 per arm) was required to achieve a power of 90% for non-inferiority with a margin of 0.4%.|Mean Difference (Final Values)|-0.09|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-0.32|0.14||Non-inferiority p-value was calculated with 2-sided comparison of the difference in treatment effects between Finesse and Pen with a non-inferiority margin of 0.4%.|ANCOVA|ANCOVA model with treatment group as a factor and baseline value as a covariate was used to compare devices for continuous measures.||||0.14|-0.32|<0.0001
72450666|NCT02542631|144421377|SUPERIORITY||Odds Ratio (OR)|1.3|STANDARD_ERROR_OF_MEAN|0.25||0.26|TWO_SIDED|95.0|0.81|2.14||Statistical test of device effects was conducted at a 2-sided alpha level of 0.05, and confidence interval (CI) was calculated at 95%, 2-sided.|Cochran-Mantel-Haenszel|||||2.14|0.81|0.26
72450667|NCT02542631|144421378|SUPERIORITY||Mean Difference (Final Values)|-2.97|STANDARD_ERROR_OF_MEAN|3.36||0.38|TWO_SIDED|95.0|-9.63|3.7||Statistical test of device effects was conducted at a 2-sided alpha level of 0.05, and confidence interval (CI) was calculated at 95%, 2-sided.|ANCOVA|ACNOVA model with treatment group as a factor and baseline value as a covariate was used to compare devices for continuous measures.||||3.70|-9.63|0.38
72450668|NCT02542631|144421379|SUPERIORITY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.14||0.99|TWO_SIDED|95.0|-0.28|0.28||Statistical test of device effects was conducted at a 2-sided alpha level of 0.05, and confidence interval (CI) was calculated at 95%, 2-sided.|ANCOVA|ANCOVA model with treatment group as a factor and baseline value as a covariate was used to compare devices for continuous measures.||||0.28|-0.28|0.99
72498977|NCT00348140|144528173|SUPERIORITY||Mean Difference (Net)|-0.7||||0.331|TWO_SIDED|95.0|-2.1|0.7|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|For Week 48||0.7|-2.1|0.331
72498978|NCT00348140|144528174|SUPERIORITY||Mean Difference (Net)|4.1||||0.251|TWO_SIDED|95.0|-2.9|11.2|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|Q1 Week 12||11.2|-2.9|0.251
72498979|NCT00348140|144528174|SUPERIORITY||Mean Difference (Net)|5.9||||0.113|TWO_SIDED|95.0|-1.4|13.2|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|Q1 Week 12||13.2|-1.4|0.113
72498980|NCT00348140|144528174|SUPERIORITY||Mean Difference (Net)|1.6||||0.723|TWO_SIDED|95.0|-7.1|10.2|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|Q1 Week 24||10.2|-7.1|0.723
72450669|NCT02542631|144421380|SUPERIORITY||Odds Ratio (OR)|1.1|STANDARD_ERROR_OF_MEAN|0.28||0.71|TWO_SIDED|95.0|0.64|1.93||Statistical test of device effects was conducted at a 2-sided alpha level of 0.05, and confidence interval (CI) was calculated at 95%, 2-sided.|Cochran-Mantel-Haenszel|||||1.93|0.64|0.71
72450670|NCT02542631|144421381|SUPERIORITY||Mean Difference (Final Values)|0.06|STANDARD_ERROR_OF_MEAN|0.09||0.52|TWO_SIDED|95.0|-0.12|0.24||Statistical test of device effects was conducted at a 2-sided alpha level of 0.05, and confidence interval (CI) was calculated at 95%, 2-sided.|ANCOVA|ANCOVA model with treatment group as a factor and week 24 value as a covariate was used to compare devices for continuous measures.||||0.24|-0.12|0.52
72450671|NCT02542631|144421382|SUPERIORITY||Mean Difference (Final Values)|9.16|STANDARD_ERROR_OF_MEAN|2.8||0.001|TWO_SIDED|95.0|3.65|14.67||Statistical test of device effects was conducted at a 2-sided alpha level of 0.05, and confidence interval (CI) was calculated at 95%, 2-sided.|ANCOVA|ANCOVA model with change in score as dependent variable, treatment as factor, and baseline score as a covariate was used to compare devices.||||14.67|3.65|0.001
72450672|NCT02542631|144421383|SUPERIORITY||Mean Difference (Final Values)|4.32|STANDARD_ERROR_OF_MEAN|2.03||0.03|TWO_SIDED|95.0|0.33|8.32||Statistical test of device effects was conducted at a 2-sided alpha level of 0.05, and confidence interval (CI) was calculated at 95%, 2-sided.|ANCOVA|ANCOVA model with change in score as dependent variable, treatment as factor, and baseline score as a covariate was used to compare devices.||||8.32|0.33|0.03
72450673|NCT02542631|144421384|SUPERIORITY|||||||1|||||||Chi-squared|||||||1.00
72450674|NCT05513937|144421429|SUPERIORITY||Mean difference pre vs post|-15.2|STANDARD_DEVIATION|8.32|<|0.001|TWO_SIDED||||||Wilcoxon signed rank test|||||||<0.001
72450675|NCT02577354|144421430|SUPERIORITY|||||||0.138||||||The threshold for statistical significance was p=0.05|Wald asymptotic test of proportions|Cui p-value adjustment for sample size re-estimation at interim analysis; Multiple imputation utilized for 3 participants lost to follow-up.||||||0.138
72498981|NCT00348140|144528174|SUPERIORITY||Mean Difference (Net)|3.5||||0.482|TWO_SIDED|95.0|-6.3|13.2|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|Q1 Week 24||13.2|-6.3|0.482
72498982|NCT00348140|144528174|SUPERIORITY||Mean Difference (Net)|1.5||||0.785|TWO_SIDED|95.0|-9.5|12.6|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|Q1 Week 36||12.6|-9.5|0.785
72450676|NCT02577354|144421431|SUPERIORITY|||||||0.032||||||Threshold for statistical significance was p=0.05|t-test, 2 sided|||||||0.032
72450677|NCT02577354|144421432|SUPERIORITY|||||||0.0499||||||The threshold for significance was p=0.05.|Friedman's regression analysis|Multiple Imputation utilized for 3 participants lost to follow-up.||||||0.0499
72450678|NCT02577354|144421434|SUPERIORITY|||||||0.011||||||Threshold for statistical significance was p=0.05|t-test, 2 sided|||||||0.011
72450679|NCT02577354|144421435|SUPERIORITY|||||||0.009||||||Threshold for statistical significance was p=0.05|t-test, 2 sided|||||||0.009
72450680|NCT02577354|144421436|SUPERIORITY||||||<|0.001||||||Threshold for statistical significance was 0.05|t-test, 2 sided|||||||<0.001
72450681|NCT02577354|144421437|SUPERIORITY|||||||0.003||||||Threshold for statistical significance was p=0.05.|Wilcoxon (Mann-Whitney)|||||||0.003
72450682|NCT02577354|144421438|SUPERIORITY|||||||0.335||||||Threshold for statistical significance was p=0.05.|Chi-squared|||||||0.335
72450683|NCT02577354|144421446|SUPERIORITY|||||||0.048||||||The threshold for statistical significance was p=0.05.|Wald asymptotic test of proportions|Multiple imputation used for three participants lost to follow-up.||||||0.048
72450684|NCT02577354|144421447|SUPERIORITY||||||<|0.001||||||"P-value for Satisfied with Treatment. Threshold for statistical significance was p=0.05"|Cochran-Mantel-Haenszel|||||||<0.001
72498983|NCT00348140|144528174|SUPERIORITY||Mean Difference (Net)|2.2||||0.711|TWO_SIDED|95.0|-9.4|13.8|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|Q1 Week 36||13.8|-9.4|0.711
72498984|NCT00348140|144528174|SUPERIORITY||Mean Difference (Net)|4.0||||0.484|TWO_SIDED|95.0|-7.2|15.2|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|Q1 Week 48||15.2|-7.2|0.484
72450685|NCT02577354|144421449|SUPERIORITY||||||<|0.001||||||Threshold for statistical significance was p=0.05.|Cochran-Mantel-Haenszel|||||||<0.001
72450686|NCT04109066|144421466|SUPERIORITY||Odds Ratio (OR)|2.05||||0.0021|TWO_SIDED|95.0|1.29|3.27|||Cochran-Mantel-Haenszel||"Stratified by PD-L1 by SP142 (\< 1% vs. \>= 1%), AC Dose-Frequency Chemotherapy Regimen (Q2W vs. Q3W) per IRT.~Strata adjusted odds ratio (Arm A over Arm B) using Mantel-Haenszel method."|Arm A over Arm B||3.27|1.29|0.0021
72450687|NCT04109066|144421466|OTHER||Adjusted Difference of pCR Rates|10.5|||||TWO_SIDED|95.0|4.0|16.9|||||"Strata adjusted difference in pCR (Arm A-B) based on Cochran-Mantel-Haenszel (CMH) method of weighting.~Stratified by PD-L1 by SP142 (\< 1% vs. \>= 1%), AC Dose-Frequency Chemotherapy Regimen (Q2W vs. Q3W) per IRT."|||16.9|4.0|
72498985|NCT00348140|144528174|SUPERIORITY||Mean Difference (Net)|3.4||||0.572|TWO_SIDED|95.0|-8.5|15.4|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|Q1 Week 48||15.4|-8.5|0.572
72450688|NCT04109066|144421467|SUPERIORITY||Odds Ratio (OR)|3.11|||||TWO_SIDED|95.0|1.58|6.11|||||Stratified by AC Dose-Frequency. Chemotherapy Regimen (Q2W vs. Q3W) per IRT. Strata adjusted odds ratio (Arm A over Arm B) using Mantel-Haenszel method.|Arm A over Arm B||6.11|1.58|
72450689|NCT04109066|144421467|OTHER||Adjusted Difference of pCR Rates|24.1|||||TWO_SIDED|95.0|10.7|37.5|||||"Strata adjusted difference in pCR (Arm A-B) based on Cochran-Mantel-Haenszel (CMH) method of weighting.~Stratified by AC Dose-Frequency Chemotherapy Regimen (Q2W vs. Q3W) per IRT."|||37.5|10.7|
72450690|NCT02510235|144421477|NON_INFERIORITY|"To declare non-inferiority between treatments, a change in the SANDE overall score of 12 mm was required, with an estimated standard deviation of 13 (approximately 70% of the mean at 28 ± 4 days after treatment).~The left inferior limits of confidence interval were determined and compared with the non-inferiority limit defined in the testing hypothesis.~Testing Hypothesis:~H0: meanHyaluronic - meanLubricin ≤ - 12~/ H1: meanHyaluronic - meanLubricin \> - 12"|Mean Difference (Final Values)|1.5|||||ONE_SIDED|95.0|-8.87||||Student t-test for unpaired data.|||Values at Day 28 ± 4 (end of treatment) for the SANDE overall VAS score were compared between treatment groups using a Student's t-test for unpaired data.|||-8.87|
72450691|NCT02510235|144421479|SUPERIORITY||Mean Difference (Final Values)|-0.77||||0.8226|TWO_SIDED|95.0|-7.66|6.11|||ANOVA|The analysis of variance included as sources of variability treatment, site and baseline tolerability score||Foreign Body Sensation in the Study Eye was analyzed using a repeated measures ANOVA, which evaluates changes from baseline across all time points in a single analysis. This method provides one overall value for comparison, as it incorporates all time points into a unified analysis. Consequently, the reported value represents the global outcome across time points, consistent with the repeated measures ANOVA methodology.||6.11|-7.66|0.8226
72450692|NCT02510235|144421479|SUPERIORITY||Mean Difference (Final Values)|3.16||||0.3178|TWO_SIDED|95.0|-3.13|9.44|||ANOVA|The analysis of variance included as sources of variability treatment, site and baseline tolerability score.||Burning/Stinging in Study eye was analyzed using a repeated measures ANOVA, which evaluates changes from baseline across all time points in a single analysis. This method provides one overall value for comparison, as it incorporates all time points into a unified analysis. Consequently, the reported value represents the global outcome across time points, consistent with the repeated measures ANOVA methodology.||9.44|-3.13|0.3178
72450693|NCT02510235|144421479|SUPERIORITY||Mean Difference (Final Values)|6.52||||0.0085|TWO_SIDED|95.0|1.74|11.3|||ANOVA|The analysis of variance included as sources of variability treatment, site and baseline tolerability score.||Itching in Study eye was analyzed using a repeated measures ANOVA, which evaluates changes from baseline across all time points in a single analysis. This method provides one overall value for comparison, as it incorporates all time points into a unified analysis. Consequently, the reported value represents the global outcome across time points, consistent with the repeated measures ANOVA methodology.||11.30|1.74|0.0085
72450694|NCT02510235|144421479|SUPERIORITY||Mean Difference (Final Values)|3.41||||0.3124|TWO_SIDED|95.0|-3.31|10.13|||ANOVA|The analysis of variance included as sources of variability treatment, site and baseline tolerability score.||Pain in Study eye was analyzed using a repeated measures ANOVA, which evaluates changes from baseline across all time points in a single analysis. This method provides one overall value for comparison, as it incorporates all time points into a unified analysis. Consequently, the reported value represents the global outcome across time points, consistent with the repeated measures ANOVA methodology.||10.13|-3.31|0.3124
72450695|NCT02510235|144421479|SUPERIORITY||Mean Difference (Final Values)|6.76||||0.0377|TWO_SIDED|95.0|0.4|13.12|||ANOVA|The analysis of variance included as sources of variability treatment, site and baseline tolerability score.||Sticky feeling in Study eye was analyzed using a repeated measures ANOVA, which evaluates changes from baseline across all time points in a single analysis. This method provides one overall value for comparison, as it incorporates all time points into a unified analysis. Consequently, the reported value represents the global outcome across time points, consistent with the repeated measures ANOVA methodology.||13.12|0.40|0.0377
72450696|NCT02510235|144421479|SUPERIORITY||Mean Difference (Final Values)|2.1||||0.5321|TWO_SIDED|95.0|-4.62|8.83|||ANOVA|The analysis of variance included as sources of variability treatment, site and baseline tolerability score.||Blurred vision in Study eye was analyzed using a repeated measures ANOVA, which evaluates changes from baseline across all time points in a single analysis. This method provides one overall value for comparison, as it incorporates all time points into a unified analysis. Consequently, the reported value represents the global outcome across time points, consistent with the repeated measures ANOVA methodology.||8.83|-4.62|0.5321
72450697|NCT02510235|144421479|SUPERIORITY||Mean Difference (Final Values)|2.32||||0.579|TWO_SIDED|95.0|-6.04|10.68|||ANOVA|The analysis of variance included as sources of variability treatment, site and baseline tolerability score.||Photophobia in Study eye was analyzed using a repeated measures ANOVA, which evaluates changes from baseline across all time points in a single analysis. This method provides one overall value for comparison, as it incorporates all time points into a unified analysis. Consequently, the reported value represents the global outcome across time points, consistent with the repeated measures ANOVA methodology.||10.68|-6.04|0.5790
72450698|NCT02510235|144421479|SUPERIORITY||Mean Difference (Final Values)|16.13||||0.3383|TWO_SIDED|95.0|-17.41|49.68|||ANOVA|The analysis of variance included as sources of variability treatment, site and baseline tolerability score.||Total ocular tolerability score in Study eye was analyzed using a repeated measures ANOVA, which evaluates changes from baseline across all time points in a single analysis. This method provides one overall value for comparison, as it incorporates all time points into a unified analysis. Consequently, the reported value represents the global outcome across time points, consistent with the repeated measures ANOVA methodology.||49.68|-17.41|0.3383
72450699|NCT02510235|144421480|SUPERIORITY||Mean Difference (Final Values)|-0.94||||0.6484|TWO_SIDED|95.0|-5.07|3.19|||ANOVA|The analysis of variance included as sources of variability treatment, site and baseline tolerability score.||Study Eye analytic statistic is presented. The Statistical Analysis section reports results from a repeated measures ANOVA, which analyzes changes from baseline across all time points in a single unified analysis. This approach provides one overall comparison value by incorporating all time points. Consequently, the reported value represents the global outcome, consistently with repeated measures ANOVA methodology.||3.19|-5.07|0.6484
72469736|NCT02201901|144463157|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Binomial test|P-value is from the 2-sided exact 1-sample binomial test for the superiority of SOF/VEL 12 weeks (Group 1) over prespecified rate of 1% .||A sample size of 75 participants per treatment group would provide over 99% power to detect 40% improvement in SVR12 rate from the assumed spontaneous rate of 1% or less using a 2-sided exact 1-sample binomial test at significance level of 0.0167.||||<0.001
72619761|NCT02191397|144770624|OTHER||Mean Difference (Final Values)|0.2||||0.05|TWO_SIDED|95.0|0.0|0.34||Analysis included Baseline HAMD-17 depressed mood subscale score as covariate, treatment, gender, visit and treatment-visit interaction as fixed effects. Unstructured covariance matrix was used.|Mixed model repeated measures analysis||Comparison for Week 4. OC dataset was used, where available data at a given time point was used with no missing values filled in with estimates.|||0.34|0.00|0.050
72450700|NCT02510235|144421481|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.7408|TWO_SIDED|95.0|-0.71|0.51|||ANOVA|The analysis of variance included as sources of variability treatment, site and baseline tolerability score.||Study Eye analytic statistic is presented. The Statistical Analysis section reports results from a repeated measures ANOVA, which analyzes changes from baseline across all time points in a single unified analysis. This approach provides one overall comparison value by incorporating all time points. Consequently, the reported value represents the global outcome, consistently with repeated measures ANOVA methodology.||0.51|-0.71|0.7408
72450701|NCT02510235|144421482|SUPERIORITY||Mean Difference (Final Values)|0.05||||0.8596|TWO_SIDED|95.0|-0.78|0.87|||ANOVA|The analysis of variance included as sources of variability treatment, site and baseline tolerability score.||Study Eye analytic statistic is presented. The Statistical Analysis section reports results from a repeated measures ANOVA, which analyzes changes from baseline across all time points in a single unified analysis. This approach provides one overall comparison value by incorporating all time points. Consequently, the reported value represents the global outcome, consistently with repeated measures ANOVA methodology.||0.87|-0.78|0.8596
72450702|NCT02510235|144421483|SUPERIORITY||Mean Difference (Final Values)|0.02||||0.7891|TWO_SIDED|95.0|-0.16|0.2|||ANOVA|The analysis of variance included as sources of variability treatment, site and baseline tolerability score.||Eyelid - Meibomian glands in Study eye analytic statistic is presented. The Statistical Analysis section reports results from a repeated measures ANOVA, which analyzes changes from baseline across all time points in a single unified analysis. This approach provides one overall comparison value by incorporating all time points. Consequently, the reported value represents the global outcome, consistently with repeated measures ANOVA methodology.||0.20|-0.16|0.7891
72450703|NCT02510235|144421483|SUPERIORITY||Mean Difference (Final Values)|-0.05||||0.6075|TWO_SIDED|95.0|-0.24|0.14|||ANOVA|The analysis of variance included as sources of variability treatment, site and baseline tolerability score.||Eyelid - Erythema in Study eye analytic statistic is presented. The Statistical Analysis section reports results from a repeated measures ANOVA, which analyzes changes from baseline across all time points in a single unified analysis. This approach provides one overall comparison value by incorporating all time points. Consequently, the reported value represents the global outcome, consistently with repeated measures ANOVA methodology.||0.14|-0.24|0.6075
72450704|NCT02510235|144421483|SUPERIORITY||Mean Difference (Final Values)|0.04||||0.6639|TWO_SIDED|95.0|-0.14|0.21|||ANOVA|The analysis of variance included as sources of variability treatment, site and baseline tolerability score.||Eyelid - Oedema in Study eye analytic statistic is presented.The Statistical Analysis section reports results from a repeated measures ANOVA, which analyzes changes from baseline across all time points in a single unified analysis. This approach provides one overall comparison value by incorporating all time points. Consequently, the reported value represents the global outcome, consistently with repeated measures ANOVA methodology.||0.21|-0.14|0.6639
72450705|NCT02510235|144421483|SUPERIORITY||Mean Difference (Final Values)|0.09||||0.3482|TWO_SIDED|95.0|-0.1|0.29|||ANOVA|The analysis of variance included as sources of variability treatment, site and baseline tolerability score.||Conjunctiva - Erythema in Study eye analytic statistic is presented.The Statistical Analysis section reports results from a repeated measures ANOVA, which analyzes changes from baseline across all time points in a single unified analysis. This approach provides one overall comparison value by incorporating all time points. Consequently, the reported value is not duplicated or triplicated, reflecting the global outcome consistent with repeated measures ANOVA methodology.||0.29|-0.10|0.3482
72498986|NCT00348140|144528174|SUPERIORITY||Mean Difference (Net)|6.8||||0.197|TWO_SIDED|95.0|-3.6|17.3|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|Q2 Week 12||17.3|-3.6|0.197
72498987|NCT00348140|144528174|SUPERIORITY||Mean Difference (Net)|7.4||||0.183|TWO_SIDED|95.0|-3.5|18.4|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|Q2 Week 12||18.4|-3.5|0.183
72450706|NCT02510235|144421483|SUPERIORITY||Mean Difference (Final Values)|-0.13||||0.2422|TWO_SIDED|95.0|-0.34|0.09|||ANOVA|The analysis of variance included as sources of variability treatment, site and baseline tolerability score.||Conjunctiva - Oedema in Study eye analytic statistic is presented.The Statistical Analysis section reports results from a repeated measures ANOVA, which analyzes changes from baseline (Visit 2 - Day 1) across all time points in a single unified analysis. This approach provides one overall comparison value by incorporating all time points. Consequently, the reported value represents the global outcome, consistently with repeated measures ANOVA methodology.||0.09|-0.34|0.2422
72561912|NCT02416934|144654662|SUPERIORITY||Mean Difference (Final Values)|-0.604|STANDARD_ERROR_OF_MEAN|0.2543|<|0.05|TWO_SIDED|95.0|-1.1151|-0.093|||t-test, 2 sided|||Comparing Bazaz between Dexamethasone and Saline at 6 months post-op||-.0930|-1.1151|<.05
72561913|NCT02416934|144654663|SUPERIORITY||Mean Difference (Final Values)|1.7874|STANDARD_ERROR_OF_MEAN|3.1273|<|0.05|TWO_SIDED|95.0|-4.5153|8.0902|||t-test, 2 sided|||Comparing the changes in VNDI between Dexamethasone and Saline from baseline to last visit||8.0902|-4.5153|<.05
72450707|NCT02510235|144421483|SUPERIORITY||Mean Difference (Final Values)|0.01||||0.8645|TWO_SIDED|95.0|-0.11|0.14|||ANOVA|The analysis of variance included as sources of variability treatment, site and baseline tolerability score.||Lens in Study eye analytic statistic is presented.The Statistical Analysis section reports results from a repeated measures ANOVA, which analyzes changes from baseline across all time points in a single unified analysis. This approach provides one overall comparison value by incorporating all time points. Consequently, the reported value represents the global outcome, consistently with repeated measures ANOVA methodology.||0.14|-0.11|0.8645
72561914|NCT02416934|144654664|SUPERIORITY|||||||0.375||||||Fisher's Exact Test|Fisher Exact|||||||.375
72561915|NCT02212457|144654712|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was concluded when, at 1 month after the second meningococcal vaccination (Visit Month 3), the lower limit of the two-sided 95% confidence interval for the between-group ratios of GMTs (ABCWY\_0\_2 versus rMenB\_0\_2) was greater than 0.5 for each of the four serogroup B test strains.|Geometric Mean Ratio|0.74|||||TWO_SIDED|95.0|0.53|1.02|||ANCOVA|||Non-inferiority response against N. meningitidis serogroup B test strain M14459 of the MenABCWY vaccine to that of the Bexsero vaccine, administered according to 0, 2 month schedule.||1.02|0.53|
72450708|NCT02510235|144421483|SUPERIORITY||Mean Difference (Final Values)|-0.03||||0.379|TWO_SIDED|95.0|-0.11|0.04|||ANOVA|The analysis of variance included as sources of variability treatment, site and baseline tolerability score.||Cornea transparency in Study eye analytic statistic is presented.The Statistical Analysis section reports results from a repeated measures ANOVA, which analyzes changes from baseline across all time points in a single unified analysis. This approach provides one overall comparison value by incorporating all time points. Consequently, the reported value represents the global outcome, consistently with repeated measures ANOVA methodology.||0.04|-0.11|0.3790
72450709|NCT02510235|144421484|SUPERIORITY||Mean Difference (Final Values)|-0.02||||0.8363|TWO_SIDED|95.0|-0.26|0.21|||ANOVA|The analysis of variance included as sources of variability treatment, site and baseline tolerability score.||Study eye analytic statistic is presented.The Statistical Analysis section reports results from a repeated measures ANOVA, which analyzes changes from baseline across all time points in a single unified analysis. This approach provides one overall comparison value by incorporating all time points. Consequently, the reported value represents the global outcome, consistently with repeated measures ANOVA methodology.||0.21|-0.26|0.8363
72450710|NCT02510235|144421485|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.6248|TWO_SIDED|95.0|-0.62|1.02|||ANOVA|The analysis of variance included as sources of variability treatment, site and baseline tolerability score.||Study eye analytic statistic is presented.The Statistical Analysis section reports results from a repeated measures ANOVA, which analyzes changes from baseline (Visit 2 - Day 1) across all time points in a single unified analysis. This approach provides one overall comparison value by incorporating all time points. Consequently, the reported value represents the global outcome, consistently with repeated measures ANOVA methodology.||1.02|-0.62|0.6248
72450711|NCT02510235|144421486|SUPERIORITY||Mean Difference (Final Values)|-0.16||||0.6153|TWO_SIDED|95.0|-0.82|0.49|||ANOVA|The analysis of variance included as sources of variability treatment, site and baseline tolerability score.||Study eye analytic statistic is presented.The Statistical Analysis section reports results from a repeated measures ANOVA, which analyzes changes from baseline (Visit 2 - Day 1) across all time points in a single unified analysis. This approach provides one overall comparison value by incorporating all time points. Consequently, the reported value represents the global outcome, consistently with repeated measures ANOVA methodology.||0.49|-0.82|0.6153
72450712|NCT03367156|144421487|OTHER||Mean Difference (Final Values)|0.0||||0.48|TWO_SIDED|95.0|-0.8|0.7|||Linear Model|||||0.7|-0.8|0.48
72450713|NCT03367156|144421488|OTHER||Mean Difference (Final Values)|0.2|||>|0.99|TWO_SIDED|95.0|-0.7|1.0|||Linear Model|||||1|-0.7|>0.99
72450714|NCT03367156|144421489|OTHER||Mean Difference (Final Values)|0.4||||0.97|TWO_SIDED|95.0|-0.7|1.6|||Linear Model|||||1.6|-0.7|0.97
72450715|NCT03367156|144421490|OTHER||Mean Difference (Final Values)|0.1||||0.78|TWO_SIDED|95.0|-0.8|1.0|||Linear Model|||||1.0|-0.8|0.78
72450716|NCT03367156|144421491|OTHER||Mean Difference (Final Values)|-0.5||||0.93|TWO_SIDED|95.0|-10.6|9.6|||Linear Model|||||9.6|-10.6|0.93
72450717|NCT03367156|144421492|OTHER||Mean Difference (Final Values)|0.6||||0.93|TWO_SIDED|95.0|-0.6|1.8|||Linear Model|||||1.8|-0.6|0.93
72450718|NCT03367156|144421493|OTHER||Mean Difference (Final Values)|0.1||||0.82|TWO_SIDED|95.0|-0.9|1.1|||Linear Model|||||1.1|-0.9|0.82
72450719|NCT03367156|144421494|OTHER||Mean Difference (Final Values)|-5.5||||0.38|TWO_SIDED|95.0|-17.9|6.9|||Linear Model|||||6.9|-17.9|0.38
72450720|NCT04881461|144421577|SUPERIORITY||Mean Difference (Final Values)|1.88||||0.0036|TWO_SIDED|95.0|0.6|3.17||Adjusted P-value.|Mixed Models Analysis|Covariates in the model: treatment, season and their interaction, ongoing asthma status, and country and season interaction|Placebo vs 5-grass mix SLIT-drops|"The null hypothesis was defined as no difference in means between treatment arms. The endpoint analysis was based on a 5% significance level. The trial was designed to have 86% power for the primary endpoint using the primary (trial product) estimand."||3.17|0.60|0.0036
72450721|NCT04881461|144421578|SUPERIORITY||Mean Difference (Final Values)|0.17||||0.1111|TWO_SIDED|95.0|-0.04|0.39||Adjusted P-value.|Mixed Models Analysis|Covariates in the model: treatment, season and their interaction, ongoing asthma status, and country and season interaction.|Placebo vs 5-grass mix SLIT-drops|"The null hypothesis was defined as no difference in means between treatment arms. The endpoint analysis was based on a 5% significance level. The trial was designed to have 95% power for this key secondary endpoint using the primary (trial product) estimand."||0.39|-0.04|0.1111
72450722|NCT04881461|144421579|SUPERIORITY||Mean Difference (Final Values)|1.33||||0.0417|TWO_SIDED|95.0|-0.01|2.67||Observed P-value|Mixed Models Analysis|Covariates in the model: treatment, season and their interaction, ongoing asthma status, and country and season interaction|Placebo vs 5-grass SLIT-drops|"The null hypothesis was defined as no difference in means between treatment arms. The analysis was based on a 5% significance level. The endpoint was analysed using primary (trial product) estimand."||2.67|-0.01|0.0417
72450723|NCT04881461|144421580|SUPERIORITY||Mean Difference (Final Values)|0.08||||0.4984|TWO_SIDED|95.0|-0.15|0.3||Observed P-value|Mixed Models Analysis|Covariates in the model: treatment, season and their interaction, ongoing asthma status, and country and season interaction|Placebo vs 5-grass SLIT drops|"The null hypothesis was defined as no difference in means between treatment arms. The analysis was based on a 5% significance level. The endpoint was analysed using primary (trial product) estimand."||0.30|-0.15|0.4984
72561916|NCT02212457|144654712|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was concluded when, at 1 month after the second meningococcal vaccination (Visit Month 3), the lower limit of the two-sided 95% confidence interval for the between-group ratios of GMTs (ABCWY\_0\_2 versus rMenB\_0\_2) was greater than 0.5 for each of the four serogroup B test strains.|Geometric Mean Ratio|0.71|||||TWO_SIDED|95.0|0.54|0.94|||ANCOVA|||Non-inferiority response against N. meningitidis serogroup B test strain M07-0241084 of the MenABCWY vaccine to that of the Bexsero vaccine, administered according to 0, 2 month schedule.||0.94|0.54|
72561917|NCT02212457|144654712|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was concluded when, at 1 month after the second meningococcal vaccination (Visit Month 3), the lower limit of the two-sided 95% confidence interval for the between-group ratios of GMTs (ABCWY\_0\_2 versus rMenB\_0\_2) was greater than 0.5 for each of the four serogroup B test strains.|Geometric Mean Ratio|0.66|||||TWO_SIDED|95.0|0.51|0.85|||ANCOVA|||Non-inferiority response against N. meningitidis serogroup B test strain 96217 of the MenABCWY vaccine to that of the Bexsero vaccine, administered according to 0, 2 month schedule.||0.85|0.51|
72391248|NCT03000439|144289779|OTHER||Difference in LS Mean|-4.28|||||TWO_SIDED|95.0|-16.74|8.18||||||DB week 40: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open label baseline value, and Open-label baseline value by visit interaction.||8.18|-16.74|
72391249|NCT03000439|144289779|OTHER||Difference in LS Mean|-8.32|||||TWO_SIDED|95.0|-15.2|-1.43||||||DB week 44: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open label baseline value, and Open-label baseline value by visit interaction.||-1.43|-15.20|
72391250|NCT03000439|144289779|OTHER||Difference in LS Mean|-4.84|||||TWO_SIDED|95.0|-12.6|2.92||||||DB week 48: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open label baseline value, and Open-label baseline value by visit interaction.||2.92|-12.60|
72391251|NCT03000439|144289779|OTHER||Difference in LS Mean|-1.34|||||TWO_SIDED|95.0|-5.16|2.48||||||DB week 52: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open label baseline value, and Open-label baseline value by visit interaction.||2.48|-5.16|
72391252|NCT03000439|144289780|OTHER||Difference in LS Mean|-6.05|||||TWO_SIDED|95.0|-16.3|4.19||||||DB week 4: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||4.19|-16.30|
72391253|NCT03000439|144289780|OTHER||Difference in LS Mean|-10.46|||||TWO_SIDED|95.0|-21.68|0.77||||||DB week 8: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||0.77|-21.68|
72391254|NCT03000439|144289780|OTHER||Difference in LS Mean|-10.86|||||TWO_SIDED|95.0|-23.75|2.03||||||DB week 12: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||2.03|-23.75|
72391255|NCT03000439|144289780|OTHER||Difference in LS Mean|-13.15|||||TWO_SIDED|95.0|-25.83|-0.46||||||DB week 16: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||-0.46|-25.83|
72391256|NCT03000439|144289780|OTHER||Difference in LS Mean|-7.02|||||TWO_SIDED|95.0|-13.56|-0.47||||||DB week 20: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||-0.47|-13.56|
72391257|NCT03000439|144289780|OTHER||Difference in LS Mean|-4.53|||||TWO_SIDED|95.0|-11.0|1.95||||||DB week 24: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||1.95|-11.00|
72391258|NCT03000439|144289780|OTHER||Difference in LS Mean|-9.35|||||TWO_SIDED|95.0|-22.24|3.54||||||DB week 28: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||3.54|-22.24|
72391259|NCT03000439|144289780|OTHER||Difference in LS Mean|-6.75|||||TWO_SIDED|95.0|-18.34|4.83||||||DB week 32: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||4.83|-18.34|
72391260|NCT03000439|144289780|OTHER||Difference in LS Mean|-15.49|||||TWO_SIDED|95.0|-30.36|-0.63||||||DB week 36: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||-0.63|-30.36|
72391261|NCT03000439|144289780|OTHER||Difference in LS Mean|-7.99|||||TWO_SIDED|95.0|-21.0|5.03||||||DB week 40: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||5.03|-21.00|
72391262|NCT03000439|144289780|OTHER||Difference in LS Mean|-10.49|||||TWO_SIDED|95.0|-17.67|-3.31||||||DB week 44: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||-3.31|-17.67|
72391263|NCT03000439|144289780|OTHER||Difference in LS Mean|-5.93|||||TWO_SIDED|95.0|-13.53|1.67||||||DB week 48: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||1.67|-13.53|
72391264|NCT03000439|144289780|OTHER||Difference in LS Mean|-2.57|||||TWO_SIDED|95.0|-6.37|1.24||||||DB week 52: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||1.24|-6.37|
72561918|NCT02212457|144654712|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was concluded when, at 1 month after the second meningococcal vaccination (Visit Month 3), the lower limit of the two-sided 95% confidence interval for the between-group ratios of GMTs (ABCWY\_0\_2 versus rMenB\_0\_2) was greater than 0.5 for each of the four serogroup B test strains.|Geometric Mean Ratio|0.49|||||TWO_SIDED|95.0|0.37|0.66|||ANCOVA|||Non-inferiority response against N. meningitidis serogroup B test strain NZ98/254 of the MenABCWY vaccine to that of the Bexsero vaccine, administered according to 0, 2 month schedule.||0.66|0.37|
72391265|NCT03000439|144289781|OTHER||Difference in LS Mean|0.51|||||TWO_SIDED|95.0|0.2|2.22||||||DB week 4: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open-Label baseline value, and Open-Label baseline value by visit interaction.||2.22|0.20|
72391266|NCT03000439|144289781|OTHER||Difference in LS Mean|0.82|||||TWO_SIDED|95.0|-0.2|1.85||||||DB week 8: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open-Label baseline value, and Open-Label baseline value by visit interaction.||1.85|-0.20|
72391267|NCT03000439|144289781|OTHER||Difference in LS Mean|0.31|||||TWO_SIDED|95.0|-0.65|1.27||||||DB week 12: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open-Label baseline value, and Open-Label baseline value by visit interaction.||1.27|-0.65|
72391268|NCT03000439|144289781|OTHER||Difference in LS Mean|0.57|||||TWO_SIDED|95.0|-0.26|1.41||||||DB week 16: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open-Label baseline value, and Open-Label baseline value by visit interaction.||1.41|-0.26|
72450724|NCT04881461|144421581|SUPERIORITY||Mean Difference (Final Values)|0.07||||0.4438|TWO_SIDED|95.0|-0.12|0.27||Observed P-value|Mixed Models Analysis|Covariates in the model: treatment, season and their interaction, ongoing asthma status, and country and season interaction|Placebo vs 5-grass mix SLIT-drops|"The null hypothesis was defined as no difference in means between treatment arms. The analysis was based on a 5% significance level. The endpoint was analysed using primary (trial product) estimand."||0.27|-0.12|0.4438
72450725|NCT04881461|144421582|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.0363|TWO_SIDED|95.0|0.01|0.38||Observed P-value.|Mixed Models Analysis|Covariates in the model: treatment, season and their interaction, ongoing asthma status, and country and season interaction|Placebo vs 5-grass mix SLIT-drops|"The null hypothesis was defined as no difference in means between treatment arms. The analysis was based on a 5% significance level. The endpoint was analysed using primary (trial product) estimand."||0.38|0.01|0.0363
72450726|NCT04881461|144421583|SUPERIORITY||Mean Difference (Final Values)|1.19||||0.0329|TWO_SIDED|95.0|0.06|2.31||Observed P-value.|Mixed Models Analysis|Covariates in the model: treatment, season and their interaction, ongoing asthma status, and country and season interaction|Placebo vs 5-grass mix SLIT drops|"The null hypothesis was defined as no difference in means between treatment arms. The analysis was based on a 5% significance level. The endpoint was analysed using primary (trial product) estimand.."||2.31|0.06|0.0329
72450727|NCT04881461|144421584|SUPERIORITY||Mean Difference (Final Values)|1.73||||0.0016|TWO_SIDED|95.0|0.66|2.79||Observed P-value.|Mixed Models Analysis|Covariates in the model: treatment, season and their interaction, ongoing asthma status, and country and season interaction|Placebo vs 5-grass mix SLIT-drops|"The null hypothesis was defined as no difference in means between treatment arms. The analysis was based on a 5% significance level. The endpoint was analysed using primary (trial product) estimand."||2.79|0.66|0.0016
72450728|NCT04881461|144421585|SUPERIORITY||Mean Difference (Final Values)|0.25||||0.4502|TWO_SIDED|95.0|-0.42|0.92||Observed P-value.|Mixed Models Analysis|Covariates in the model: treatment, season and their interaction, ongoing asthma status, and country and season interaction|Placebo vs 5-grass mix SLIT-drops|"The null hypothesis was defined as no difference in means between treatment arms. The analysis was based on a 5% significance level. The endpoint was analysed using primary (trial product) estimand."||0.92|-0.42|0.4502
72450729|NCT04881461|144421586|SUPERIORITY||Mean Difference (Final Values)|0.55||||0.1177|TWO_SIDED|95.0|-0.14|1.23||Observed P-value|Mixed Models Analysis|Covariates in the model: treatment, season and their interaction, ongoing asthma status, and country and season interaction|Placebo vs 5-grass mix SLIT-drops|"The null hypothesis was defined as no difference in means between treatment arms. The analysis was based on a 5% significance level. The endpoint was analysed using primary (trial product) estimand."||1.23|-0.14|0.1177
72450730|NCT04881461|144421587|SUPERIORITY||Mean Difference (Final Values)|0.21||||0.4604|TWO_SIDED|95.0|-0.37|0.79||Observed P-value|Mixed Models Analysis|Covariates in the model: treatment, season and their interaction, ongoing asthma status, and country and season interaction|Placebo vs 5-grass mix SLIT-drops|"The null hypothesis was defined as no difference in means between treatment arms. The analysis was based on a 5% significance level. The endpoint was analysed using primary (trial product) estimand."||0.79|-0.37|0.4604
72450731|NCT04881461|144421588|SUPERIORITY||Mean Difference (Final Values)|0.57||||0.0549|TWO_SIDED|95.0|-0.01|1.15||Observed P-value.|Mixed Models Analysis|Covariates in the model: treatment, season and their interaction, ongoing asthma status, and country and season interaction|Placebo vs 5-grass mix SLIT-drops|"The null hypothesis was defined as no difference in means between treatment arms. The analysis was based on a 5% significance level. The endpoint was analysed using primary (trial product) estimand."||1.15|-0.01|0.0549
72391269|NCT03000439|144289781|OTHER||Difference in LS Mean|0.16|||||TWO_SIDED|95.0|-0.78|1.1||||||DB week 20: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open-Label baseline value, and Open-Label baseline value by visit interaction.||1.10|-0.78|
72391270|NCT03000439|144289781|OTHER||Difference in LS Mean|0.66|||||TWO_SIDED|95.0|-0.18|1.49||||||DB week 24: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open-Label baseline value, and Open-Label baseline value by visit interaction.||1.49|-0.18|
72450732|NCT04881461|144421589|SUPERIORITY||Mean Difference (Final Values)|1.12||||0.0049|TWO_SIDED|95.0|0.3|1.93||Observed P-value.|Mixed Models Analysis|Covariates in the model: treatment, season and their interaction, ongoing asthma status, and country and season interaction|Placebo vs 5-grass mix SLIT-drops|"The null hypothesis was defined as no difference in means between treatment arms. The analysis was based on a 5% significance level. The endpoint was analysed using primary (trial product) estimand."||1.93|0.30|0.0049
72450733|NCT04881461|144421590|SUPERIORITY||Mean Difference (Final Values)|1.24||||0.0004|TWO_SIDED|95.0|0.54|1.95||Observed P-value.|Mixed Models Analysis|Covariates in the model: treatment, season and their interaction, ongoing asthma status, and country and season interaction|Placebo vs 5-grass mix SLIT-drops|"The null hypothesis was defined as no difference in means between treatment arms. The analysis was based on a 5% significance level. The endpoint was analysed using primary (trial product) estimand."||1.95|0.54|0.0004
72498988|NCT00348140|144528174|SUPERIORITY||Mean Difference (Net)|10.0||||0.121|TWO_SIDED|95.0|-2.6|22.6|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|Q2 Week 24||22.6|-2.6|0.121
72561919|NCT00948792|144654748|SUPERIORITY_OR_OTHER|||||||0.8||95.0|||||Wilcoxon (Mann-Whitney)|||"The null hypothesis is that there would be no difference in post-transfusion platelet counts (30-minutes post-transfusion) between the two groups.~We opted to determine the number of transfusions that would be required to detect difference of 20,000 platelets/mm3 (with a standard deviation of 20,000). The number shown to demonstrate this was 44."||||0.8
72561920|NCT00948792|144654749|SUPERIORITY_OR_OTHER|||||||0.26||95.0|||||Wilcoxon (Mann-Whitney)|||"The null hypothesis is that there would be no difference in post-transfusion platelet counts (6-hour post-transfusion) between the two groups.~We opted to determine the number of transfusions that would be required to detect difference of 20,000 platelets/mm3 (with a standard deviation of 20,000). The number shown to demonstrate this was 44."||||0.26
72450734|NCT04881461|144421591|SUPERIORITY||Mean Difference (Final Values)|0.94||||0.0054|TWO_SIDED|95.0|0.25|1.63||Observed P-value.|Mixed Models Analysis|Covariates in the model: treatment, season and their interaction, ongoing asthma status, and country and season interaction|Placebo vs 5-grass mix SLIT-drops|"The null hypothesis was defined as no difference in means between treatment arms. The analysis was based on a 5% significance level. The endpoint was analysed using primary (trial product) estimand."||1.63|0.25|0.0054
72450735|NCT04881461|144421592|SUPERIORITY||Mean Difference (Final Values)|1.11||||0.0002|TWO_SIDED|95.0|0.52|1.71||Observed P-value.|Mixed Models Analysis|Covariates in the model: treatment, season and their interaction, ongoing asthma status, and country and season interaction|Placebo vs 5-grass mix SLIT-drops|"The null hypothesis was defined as no difference in means between treatment arms. The analysis was based on a 5% significance level. The endpoint was analysed using primary (trial product) estimand."||1.71|0.52|0.0002
72450736|NCT04084574|144421618|SUPERIORITY||Mean Difference (Net)|-4.9|STANDARD_DEVIATION|13.5||0.3968|TWO_SIDED|95.0|-16.8|6.9||The threshold for statistical significance is p = 0.05|t-test, 2 sided||Between group difference in mean blood pressure change from baseline for Standard of Care group minus Behavioral Diet Counseling group.|||6.9|-16.8|0.3968
72450737|NCT04084574|144421619|SUPERIORITY||Mean Difference (Net)|0.05|STANDARD_DEVIATION|0.5||0.07926|TWO_SIDED|95.0|-0.33|0.44|||t-test, 2 sided||Between group difference from baseline for Standard of Care group minus Behavioral Diet Counseling group.|||0.44|-0.33|0.07926
72450738|NCT04084574|144421621|SUPERIORITY||Mean Difference (Net)|11.7|STANDARD_DEVIATION|59.3||0.0673|TWO_SIDED|95.0|-34.2|58.6|||t-test, 2 sided|||||58.6|-34.2|0.0673
72450739|NCT04084574|144421622|SUPERIORITY||Mean Difference (Net)|-10.7|STANDARD_DEVIATION|189.3||0.8821|TWO_SIDED|95.0|-157.8|136.4|||t-test, 2 sided||Between group difference from baseline for Standard of Care group minus Behavioral Diet Counseling group.|||136.4|-157.8|0.8821
72450740|NCT04084574|144421623|SUPERIORITY||Mean Difference (Net)|0.6|STANDARD_DEVIATION|3.3||0.6479|TWO_SIDED|95.0|-2.0|3.1|||t-test, 2 sided||Between group difference from baseline for Standard of Care group minus Behavioral Diet Counseling group.|||3.1|-2.0|0.6479
72450741|NCT04084574|144421624|SUPERIORITY||Mean Difference (Net)|7.0|STANDARD_DEVIATION|21.8||0.4044|TWO_SIDED|95.0|-10.0|24.0|||t-test, 2 sided||Between group difference in mean blood pressure change from baseline for Behavioral Diet Counseling group minus Standard of Care group.|||24.0|-10.0|0.4044
72450742|NCT04084574|144421625|SUPERIORITY||Mean Difference (Net)|1.34|STANDARD_DEVIATION|2.91||0.2374|TWO_SIDED|95.0|-0.97|3.6|||t-test, 2 sided|||||3.60|-0.97|0.2374
72450743|NCT04084574|144421626|SUPERIORITY||Mean Difference (Net)|-2.69|STANDARD_DEVIATION|13.62||0.6188|TWO_SIDED|95.0|-13.71|8.33|||t-test, 2 sided||Between group difference from 12 weeks to 24 weeks for Behavioral Diet Counseling group minus Standard of Care group.|||8.33|-13.71|0.6188
72450744|NCT04084574|144421627|SUPERIORITY||Mean Difference (Net)|-1.39|STANDARD_DEVIATION|1.79||0.0546|TWO_SIDED|95.0|-2.82|0.03|||t-test, 2 sided||Between group difference from 12 weeks to 24 weeks for Behavioral Diet Counseling group minus Standard of Care group.|||0.03|-2.82|0.0546
72450745|NCT04084574|144421628|SUPERIORITY||Mean Difference (Net)|0.0|STANDARD_DEVIATION|1.2||1|TWO_SIDED|95.0|-0.98|0.98|||t-test, 2 sided||Between group difference from 12 weeks to 24 weeks for Behavioral Diet Counseling group minus Standard of Care group.|||0.98|-0.98|1.00
72450746|NCT04084574|144421629|SUPERIORITY||Mean Difference (Net)|0.3|STANDARD_DEVIATION|1.5||1|TWO_SIDED|95.0|-0.89|1.49|||t-test, 2 sided|||||1.49|-0.89|1.00
72450747|NCT02641730|144421630|SUPERIORITY||Mean Difference (Final Values)|-7.69|STANDARD_ERROR_OF_MEAN|1.674|<|0.001|TWO_SIDED|95.0|-11.0|-4.383|||Mixed-Model for Repeated Measures|||||-4.383|-11.000|<0.001
72450748|NCT02641730|144421630|SUPERIORITY||Mean Difference (Final Values)|-4.11|STANDARD_ERROR_OF_MEAN|1.7||0.017|TWO_SIDED|95.0|-7.468|-0.748|||Mixed-Model for Repeated Measures|||||-0.748|-7.468|0.017
72450749|NCT04068792|144421650|OTHER||Mean Difference (Final Values)|-1.03|||||TWO_SIDED|90.0|-4.467|2.416||||||||2.416|-4.467|
72450750|NCT03663205|144421692|SUPERIORITY||Hazard Ratio (HR)|0.651||||0.0054|TWO_SIDED|95.0|0.465|0.912|||One-sided, Log Rank Test||Stratified by stratification factors: disease stage (IIIB or IV) and the level of PD-L1 expression in tumor cells (\>=50%, 1% to 49%, \<1%)|||0.912|0.465|0.0054
72450751|NCT03663205|144421699|OTHER||Least squares mean difference|-2.2|||||TWO_SIDED|95.0|-7.4|3.1|||||Based on a constrained longitudinal data analysis model with QLQ-LC13 coughing score on the response variable and treatment by study visit interaction and randomization stratification factors as covariates.|Least squares mean difference in coughing score||3.1|-7.4|
72450752|NCT03663205|144421699|OTHER||Least squares mean difference|-1.2|||||TWO_SIDED|95.0|-4.4|2.1|||||Based on a constrained longitudinal data analysis model with QLQ-LC13 dyspnea score on the response variable and treatment by study visit interaction and randomization stratification factors as covariates.|Least squares mean difference in dyspnea score||2.1|-4.4|
72450753|NCT03663205|144421699|OTHER||Least squares mean difference|-3.2|||||TWO_SIDED|95.0|-7.6|1.2|||||Based on a constrained longitudinal data analysis model with QLQ-LC13 chest pain score on the response variable and treatment by study visit interaction and randomization stratification factors as covariates.|Least squares mean difference in chest pain score||1.2|-7.6|
72450754|NCT03663205|144421700|OTHER||Least squares mean difference|3.9|||||TWO_SIDED|95.0|-0.9|8.7|||||Based on a constrained longitudinal data analysis model with QLQ-LC30 Global Health Status/Quality of Life score on the response variable and treatment by study visit interaction and randomization stratification factors as covariates.|Least squares mean difference in Global Health Status/Quality of Life score||8.7|-0.9|
72450755|NCT02326974|144421703|SUPERIORITY||||||<|0.001|||||||Mantel Haenszel|||By estimating that the overall pCR with T-DM1 plus pertuzumab would be approximately 40%, and 20% of the population classified as heterogeneous, the study would have 80% power with 136 evaluable patients to detect a difference in pCR of 44.9% in the non-heterogenous versus 20.3% in the heterogenous subgroup. The study had a 90% power to detect difference in pCR of 43.4% in the non-heterogenous versus 8.8% in the heterogenous subgroup if the observed prevalence of HER2 heterogeneity was 10%.||||<0.001
72450756|NCT04424316|144421739|OTHER||Vaccine Efficacy|57.6|||||TWO_SIDED|95.0|31.3|74.6||||||Vaccine efficacy was calculated as 1-(P/\[1-P\]), where P is the number of cases in the RSVpreF group divided by the total number of cases. Vaccine efficacy was presented in percentage.||74.6|31.3|
72450757|NCT04424316|144421740|OTHER||Vaccine Efficacy|54.5|||||TWO_SIDED|95.0|33.2|69.5||||||Vaccine efficacy was calculated as 1-(P/\[1-P\]), where P is the number of cases in the RSVpreF group divided by the total number of cases. Vaccine efficacy was presented in percentage.||69.5|33.2|
72450758|NCT04424316|144421741|OTHER||Vaccine Efficacy|50.0|||||TWO_SIDED|95.0|30.3|64.5||||||Vaccine efficacy was calculated as 1-(P/\[1-P\]), where P is the number of cases in the RSVpreF group divided by the total number of cases. Vaccine efficacy was presented in percentage.||64.5|30.3|
72391271|NCT03000439|144289781|OTHER||Difference in LS Mean|-0.08|||||TWO_SIDED|95.0|-1.43|1.27||||||DB week 28: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open-Label baseline value, and Open-Label baseline value by visit interaction.||1.27|-1.43|
72450759|NCT04424316|144421742|OTHER||Vaccine Efficacy|49.2|||||TWO_SIDED|95.0|31.4|62.8||||||Vaccine efficacy was calculated as 1-(P/\[1-P\]), where P is the number of cases in the RSVpreF group divided by the total number of cases. Vaccine efficacy was presented in percentage.||62.8|31.4|
72450760|NCT04424316|144421743|OTHER||Vaccine Efficacy|82.4|||||TWO_SIDED|95.0|57.5|93.9||||||Vaccine efficacy was calculated as 1-(P/\[1-P\]), where P is the number of cases in the RSVpreF group divided by the total number of cases. Vaccine efficacy was presented in percentage.||93.9|57.5|
72450761|NCT04424316|144421744|OTHER||Vaccine Efficacy|73.5|||||TWO_SIDED|95.0|50.3|86.8||||||Vaccine efficacy was calculated as 1-(P/\[1-P\]), where P is the number of cases in the RSVpreF group divided by the total number of cases. Vaccine efficacy was presented in percentage.||86.8|50.3|
72450762|NCT04424316|144421745|OTHER||Vaccine Efficacy|70.5|||||TWO_SIDED|95.0|49.4|83.6||||||Vaccine efficacy was calculated as 1-(P/\[1-P\]), where P is the number of cases in the RSVpreF group divided by the total number of cases. Vaccine efficacy was presented in percentage.||83.6|49.4|
72450763|NCT04424316|144421746|OTHER||Vaccine Efficacy|70.0|||||TWO_SIDED|95.0|50.6|82.5||||||Vaccine efficacy was calculated as 1-(P/\[1-P\]), where P is the number of cases in the RSVpreF group divided by the total number of cases. Vaccine efficacy was presented in percentage.||82.5|50.6|
72450764|NCT04424316|144421762|OTHER||Vaccine efficacy|69.7|||||TWO_SIDED|95.0|37.1|86.7||||||Vaccine efficacy within 90 days after birth. Vaccine efficacy was calculated as 1-(P/\[1-P\]), where P is the number of cases in the RSVpreF group divided by the total number of cases. Vaccine efficacy was presented in percentage.||86.7|37.1|
72450765|NCT04424316|144421762|OTHER||Vaccine efficacy|61.5|||||TWO_SIDED|95.0|28.6|80.3||||||Vaccine efficacy within 120 days after birth. Vaccine efficacy was calculated as 1-(P/\[1-P\]), where P is the number of cases in the RSVpreF group divided by the total number of cases. Vaccine efficacy was presented in percentage.||80.3|28.6|
72450766|NCT04424316|144421762|OTHER||Vaccine efficacy|57.1|||||TWO_SIDED|95.0|23.9|76.8||||||Vaccine efficacy within 150 days after birth. Vaccine efficacy was calculated as 1-(P/\[1-P\]), where P is the number of cases in the RSVpreF group divided by the total number of cases. Vaccine efficacy was presented in percentage.||76.8|23.9|
72450767|NCT04424316|144421762|OTHER||Vaccine efficacy|55.3|||||TWO_SIDED|95.0|23.8|74.6||||||Vaccine efficacy within 180 days after birth. Vaccine efficacy was calculated as 1-(P/\[1-P\]), where P is the number of cases in the RSVpreF group divided by the total number of cases. Vaccine efficacy was presented in percentage.||74.6|23.8|
72450768|NCT04424316|144421762|OTHER||Vaccine efficacy|24.2|||||TWO_SIDED|95.0|-11.1|48.6||||||Vaccine efficacy within 360 days after birth. Vaccine efficacy was calculated as 1-(P/\[1-P\]), where P is the number of cases in the RSVpreF group divided by the total number of cases. Vaccine efficacy was presented in percentage.||48.6|-11.1|
72450769|NCT04424316|144421763|OTHER||Vaccine efficacy|9.5|||||TWO_SIDED|95.0|-10.1|25.7||||||Vaccine efficacy within 90 days after birth. Vaccine efficacy was calculated as 1-(P/\[1-P\]), where P is the number of cases in the RSVpreF group divided by the total number of cases. The confidence interval was adjusted using Bonferroni procedure and accounting for the primary endpoints results. Vaccine efficacy was presented in percentage.||25.7|-10.1|
72450770|NCT04424316|144421763|OTHER||Vaccine efficacy|6.7|||||TWO_SIDED|95.0|-9.8|20.7||||||Vaccine efficacy within 120 days after birth. Vaccine efficacy was calculated as 1-(P/\[1-P\]), where P is the number of cases in the RSVpreF group divided by the total number of cases. The confidence interval was adjusted using Bonferroni procedure and accounting for the primary endpoints results. Vaccine efficacy was presented in percentage.||20.7|-9.8|
72450771|NCT04424316|144421763|OTHER||Vaccine efficacy|7.7|||||TWO_SIDED|95.0|-6.5|20.1||||||Vaccine efficacy within 150 days after birth. Vaccine efficacy was calculated as 1-(P/\[1-P\]), where P is the number of cases in the RSVpreF group divided by the total number of cases. The confidence interval was adjusted using Bonferroni procedure and accounting for the primary endpoints results. Vaccine efficacy was presented in percentage.||20.1|-6.5|
72450772|NCT04424316|144421763|OTHER||Vaccine efficacy|4.1|||||TWO_SIDED|95.0|-9.5|16.0||||||Vaccine efficacy within 180 days after birth. Vaccine efficacy was calculated as 1-(P/\[1-P\]), where P is the number of cases in the RSVpreF group divided by the total number of cases. The confidence interval was adjusted using Bonferroni procedure and accounting for the primary endpoints results. Vaccine efficacy was presented in percentage.||16.0|-9.5|
72498989|NCT00348140|144528174|SUPERIORITY||Mean Difference (Net)|6.8||||0.291|TWO_SIDED|95.0|-5.8|19.3|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|Q2 Week 24||19.3|-5.8|0.291
72450773|NCT04424316|144421763|OTHER||Vaccine efficacy|4.6|||||TWO_SIDED|95.0|-6.6|14.6||||||Vaccine efficacy within 360 days after birth. Vaccine efficacy was calculated as 1-(P/\[1-P\]), where P is the number of cases in the RSVpreF group divided by the total number of cases. The confidence interval was adjusted using Bonferroni procedure and accounting for the primary endpoints results. Vaccine efficacy was presented in percentage.||14.6|-6.6|
72450774|NCT04424316|144421764|OTHER||Vaccine efficacy|43.8|||||TWO_SIDED|95.0|25.6|57.7||||||Vaccine efficacy at 210 days after birth. Vaccine efficacy was calculated as 1-(P/\[1-P\]), where P is the number of cases in the RSVpreF group divided by the total number of cases. The confidence interval was adjusted using Bonferroni procedure and accounting for the primary endpoints results. Vaccine efficacy was presented in percentage.||57.7|25.6|
72561921|NCT00948792|144654750|SUPERIORITY_OR_OTHER|||||||0.09||95.0|||||Wilcoxon (Mann-Whitney)|||"The null hypothesis is that there would be no difference in the change in post-transfusion platelet counts (30 minutes and 6 hours post-transfusion) between the two groups.~We opted to determine the number of transfusions that would be required to detect difference of 20,000 platelets/mm3 (with a standard deviation of 20,000). The number shown to demonstrate this was 44."||||0.09
72450775|NCT04424316|144421764|OTHER||Vaccine efficacy|39.7|||||TWO_SIDED|95.0|21.3|54.1||||||Vaccine efficacy at 240 days after birth. Vaccine efficacy was calculated as 1-(P/\[1-P\]), where P is the number of cases in the RSVpreF group divided by the total number of cases. The confidence interval was adjusted using Bonferroni procedure and accounting for the primary endpoints results. Vaccine efficacy was presented in percentage.||54.1|21.3|
72450776|NCT04424316|144421764|OTHER||Vaccine efficacy|35.0|||||TWO_SIDED|95.0|16.1|49.9||||||Vaccine efficacy at 270 days after birth. Vaccine efficacy was calculated as 1-(P/\[1-P\]), where P is the number of cases in the RSVpreF group divided by the total number of cases. The confidence interval was adjusted using Bonferroni procedure and accounting for the primary endpoints results. Vaccine efficacy was presented in percentage.||49.9|16.1|
72450777|NCT04424316|144421764|OTHER||Vaccine efficacy|33.0|||||TWO_SIDED|95.0|15.2|47.1||||||Vaccine efficacy at 360 days after birth. Vaccine efficacy was calculated as 1-(P/\[1-P\]), where P is the number of cases in the RSVpreF group divided by the total number of cases. The confidence interval was adjusted using Bonferroni procedure and accounting for the primary endpoints results. Vaccine efficacy was presented in percentage.||47.1|15.2|
72450778|NCT00412607|144421785|SUPERIORITY_OR_OTHER_LEGACY||Percentage of mortality|13.3|||||ONE_SIDED|95.0||17.5|||Fisher Exact||The 95% confidence interval is a one-sided with upper confidence level = 17.5% computed using the exact binomial test.|"Assumptions for sample size calculation: 10% attrition rate, Type I error of 0.05, anticipated 12-month mortality rate is 0.19, a region of indifference of 0.07, power of 0.8; the required sample size is 249 per nQuery Exact test for single proportion method.~The null hypothesis is that the 12-month mortality rate is greater than or equal to 0.26; the alternative is that the rate is less than 0.26. This hypothesis is evaluated with one-sided exact binomial test at α= 0.05."||17.5||
72450779|NCT03995979|144421791|SUPERIORITY|||||||0.05||||||The P-value was calculated using a paired t test|Paired t-test|||A compositional analysis with species-level alpha diversity will be performed between the three conditions (Pre-Dietary Restriction, Dietary Restriction, and Post-Dietary Restriction,) with ANOVA testing. Furthermore, a differential abundance analysis will be performed to further identify and confirm prevalent organisms associated with the experimental dietary restriction.||||0.05
72450780|NCT05652010|144421793|OTHER|Comparative study|Odds Ratio (OR)|0.576||||0.164|TWO_SIDED|95.0|0.2634|1.2659||P=0.164 for testing the hypothesis that OR=1|Mixed Models Analysis|Generalized linear mixed model. As it was an exploratory study no adjustment for multiple comparison was performed.|P=0.164 for testing the hypothesis that OR=1|||1.2659|0.2634|0.164
72450781|NCT05652010|144421794|OTHER||Binominal|0.9|||<|0.0001|TWO_SIDED|95.0|0.75|0.97|||Exact test in the binomial distribution|Exact test in the binomial distribution tested if the proportion of very satisfied/satisfied was sign. different from 50% when using a 5% test level|The binomial proportion is based on subjects that have answered the questions. Exact test in the binomial distribution.|||0.97|0.75|<0.0001
72450782|NCT05652010|144421795|OTHER|The binomial proportion is based on subjects that have answered the questions. Exact test in the binomial distribution.|Binominal|0.82|||<|0.0001|TWO_SIDED|95.0|0.66|0.92|||Exact test in the binominal distribution|Exact test in the binomial distribution tested if the proportion of YES was significantly different from 50% when using a 5% test level||||0.92|0.66|<0.0001
72450783|NCT05652010|144421796|OTHER||Odds Ratio (OR)|0.259||||0.027|TWO_SIDED|95.0|0.078|0.855||P=0.027 for testing the hypothesis that OR=1|Mixed Models Analysis|Generalized linear mixed model|P=0.027 for testing the hypothesis that OR=1|||0.855|0.078|0.027
72450784|NCT00450216|144421834|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|9.8|||<|0.0001|TWO_SIDED|95.0|4.4|15.3||CMH test stratified by use of low-dose aspirin (yes/no) and prior upper gastrointestinal (UGI) ulcer history (yes/no) at randomization.|Cochran-Mantel-Haenszel|||The primary efficacy endpoint was the number of participants developing gastric ulcers throughout 24 weeks of treatment. A summary, including cumulative frequency and percentage with associated 95% confidence intervals was produced for the observational incidences of gastric ulcers at 24 weeks. The cumulative number of participants developing gastric ulcers at 24 weeks was analyzed using the Cochran-Mantel-Haenszel (CMH) test stratified by use of low-dose aspirin and prior UGI ulcer history.||15.3|4.4|<0.0001
72450785|NCT00450216|144421835|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|11.8|||<|0.0001|TWO_SIDED|95.0|6.1|17.6||CMH test stratified by use of low-dose aspirin (yes/no) and prior UGI ulcer history (yes/no) at randomization.|Cochran-Mantel-Haenszel|||The secondary efficacy endpoint was the number of participants developing UGI (i.e., gastric and/or duodenal) ulcers throughout 24 weeks of treatment. A summary, including cumulative frequency and percentage with associated 95% confidence intervals was produced for the observational incidences of UGI ulcers at 24 weeks. The cumulative number of participants developing UGI ulcers at 24 weeks was analyzed using the CMH test stratified by use of low-dose aspirin and prior UGI ulcer history.||17.6|6.1|<0.0001
72450786|NCT00450216|144421836|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|3.8||||0.0006|TWO_SIDED|95.0|1.0|6.8||CMH test stratified by use of low-dose aspirin (yes/no) and prior UGI ulcer history (yes/no) at randomization.|Cochran-Mantel-Haenszel|||The secondary efficacy endpoint was the number of participants developing duodenal ulcers throughout 24 weeks of treatment. A summary, including cumulative frequency and percentage with associated 95% confidence intervals was produced for the observational incidences of duodenal ulcers at 24 weeks. The cumulative number of participants developing duodenal ulcers at 24 weeks was analyzed using the CMH test stratified by use of low-dose aspirin and prio UGI ulcer history at randomization.||6.8|1.0|0.0006
72450787|NCT02905331|144421873|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||<0.001
72450788|NCT02905331|144421874|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||< 0.001
72450789|NCT02905331|144421879|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
72561922|NCT01958060|144654792|SUPERIORITY_OR_OTHER||Slope|1.0604|STANDARD_ERROR_OF_MEAN|0.0337|||TWO_SIDED|95.0|0.9901|1.1308|||||Dose proportionality was explored using linear regression model (ANOVA).The perfect dose proportionality would correspond to a slope β of 1.PK endpoints on the log-transformed scale.Standard error (SE) of the mean is actually the SE of the slope.|This was non confirmatory testing (Single dose). Dose proportionality of BI 1034020 following iv administration of single rising doses of 5 mg, 10 mg, 20 mg and 50 mg for Cmax was analysed.||1.1308|0.9901|
72450790|NCT01385202|144421883|SUPERIORITY_OR_OTHER_LEGACY||Primary effectiveness rate|70.2|||<|0.0001|TWO_SIDED|95.0|60.9|78.4||In the worst-case scenario analysis, over seventy-percent (70.2%, 80/114) of the primary effectiveness cohort (PEC) were free from documented symptomatic atrial tachyarrhythmias during their effectiveness evaluation period.|Fisher Exact|The lower bound of the 95% confidence intervals was 60.9%, significantly higher than the pre-determined performance goal of 50% (p\<0.0001).|The confidence intervals above are the 95% exact binomial confidence intervals.|The null hypothesis was that the rate of freedom from documented symptomatic AF/AFL/AT at 12 months would be less than or equal to the pre-determined performance criterion of 50%. The alternative hypothesis was that the rate of freedom from documented symptomatic AF/AFL/AT at 12 months would be greater than the pre-determined performance criterion of 50%.||78.4|60.9|<0.0001
72450791|NCT01385202|144421883|SUPERIORITY_OR_OTHER_LEGACY||Primary effectiveness rate|74.0|||||TWO_SIDED|95.0|66.0|82.0|||||The 95% confidence intervals above were calculated using the Kaplan-Meier (KM) method.|||82|66|
72450792|NCT04102111|144421894|OTHER||Least Squares Means|37.4||||0.288|TWO_SIDED|90.0|-21.0|95.8|||Mixed Model for Repeated Measures (MMRM)|||||95.8|-21.0|0.288
72450793|NCT03334695|144421924|SUPERIORITY|||||||0.012|||||||Wilcoxon Rank Sum test|||||||0.012
72450794|NCT03969563|144422012|EQUIVALENCE|Equivalence based on non-significant difference between MBSR and Brain Health groups.|Mean Difference (Final Values)|0.3||||0.694|TWO_SIDED||||||Mixed Models Analysis|||||||.694
72450795|NCT03969563|144422013|EQUIVALENCE|Equivalence based on non-significant difference between MBSR vs Brain Health group.|Mean Difference (Final Values)|-1.4||||0.837|TWO_SIDED||||||Mixed Models Analysis|||||||.837
72450796|NCT01474122|144422020|SUPERIORITY_OR_OTHER_LEGACY||NB-2 estimate of new DUs per patient|1.194||||0.434|TWO_SIDED|95.0|0.766|1.861|||negative binomial-2 regression (NB-2)||The estimated value corresponds to the treatment effect i.e. the ratio between the estimated number of new DUs in macitentan 3 mg and in placebo|||1.861|0.766|0.434
72450797|NCT01474122|144422020|SUPERIORITY_OR_OTHER_LEGACY||NB-2 estimate of new DUs per patient|1.208||||0.407|TWO_SIDED|95.0|0.773|1.886|||NB-2||The estimated value corresponds to the treatment effect i.e. the ratio between the estimated number of new DUs in macitentan 10 mg and in placebo|||1.886|0.773|0.407
72450798|NCT01474122|144422021|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.831||||0.5668|TWO_SIDED|95.0|0.442|1.564|||Chi-squared|||||1.564|0.442|0.5668
72450799|NCT01474122|144422021|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.789||||0.4624|TWO_SIDED|95.0|0.42|1.484|||Chi-squared|||||1.484|0.420|0.4624
72450800|NCT01474122|144422022|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.216||||0.6117|TWO_SIDED|95.0|0.572|2.582|||Chi-squared|||||2.582|0.572|0.6117
72450801|NCT01474122|144422022|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.048||||0.9047|TWO_SIDED|95.0|0.485|2.264|||Chi-squared|||||2.264|0.485|0.9047
72450802|NCT01474122|144422023|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.1||||0.347|TWO_SIDED|95.0|-0.2|0.1|||ANCOVA|||||0.1|-0.2|0.347
72450803|NCT01474122|144422023|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.1||||0.165|TWO_SIDED|95.0|-0.3|0.0|||ANCOVA|||||0.0|-0.3|0.165
72450804|NCT01474122|144422024|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.1||||0.339|TWO_SIDED|95.0|-0.2|0.1|||ANCOVA|||||0.1|-0.2|0.339
72450805|NCT01474122|144422024|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.1||||0.312|TWO_SIDED|95.0|-0.2|0.1|||ANCOVA|||||0.1|-0.2|0.312
72450806|NCT01474122|144422025|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.1||||0.319|TWO_SIDED|95.0|-0.4|0.1|||ANCOVA|||||0.1|-0.4|0.319
72450807|NCT01474122|144422025|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.2||||0.221|TWO_SIDED|95.0|-0.4|0.1|||ANCOVA|||||0.1|-0.4|0.221
72619762|NCT02191397|144770624|OTHER||Mean Difference (Final Values)|0.1||||0.337|TWO_SIDED|95.0|-0.09|0.26||Analysis included Baseline HAMD-17 depressed mood subscale score as covariate, treatment, gender, visit and treatment-visit interaction as fixed effects. Unstructured covariance matrix was used.|Mixed model repeated measures analysis||Comparison for Week 6. OC dataset was used, where available data at a given time point was used with no missing values filled in with estimates.|||0.26|-0.09|0.337
72450808|NCT04173247|144422030|OTHER|A t-test with 180 degrees of freedom to compare the mean DLQI score over the 6 weeks in arm1 to the mean DLQI score over six weeks in arm2.||||||0.28|||||||t-test, 1 sided|||||||0.28
72450809|NCT05683158|144422089|OTHER||Mean Difference (Net)|1.71|STANDARD_ERROR_OF_MEAN|0.28|<|0.001|TWO_SIDED||||||ANOVA||Mean difference between two groups of movement unit in forward direction|To determine the sample size, the G\*Power software was utilized, incorporating an effect size (d) of 1.9, alpha level of 0.05, and power of 0.8. A sample size of six individuals per group was considered sufficient to achieve adequate statistical power, which are α ≤ 0.05, power = 0.8, and β = 0.2.||||<.001
72450810|NCT05683158|144422089|OTHER||Mean Difference (Net)|0.44|STANDARD_ERROR_OF_MEAN|0.12|<|0.001|TWO_SIDED||||||ANOVA||Statistics difference among forward, ipsilateral and contralateral directions in within group|To determine the sample size, the G\*Power software was utilized, incorporating an effect size (d) of 1.9, alpha level of 0.05, and power of 0.8. A sample size of six individuals per group was considered sufficient to achieve adequate statistical power, which are α ≤ 0.05, power = 0.8, and β = 0.2.||||<.001
72450811|NCT03812614|144422103|SUPERIORITY||Mean Difference (Final Values)|0.54||||0.07|TWO_SIDED|95.0|-0.05|1.14|||Mixed Models Analysis||Positive coefficient favors I-DSMES; negative coefficient favors FAM-ACT|Linear mixed model with random intercept and slope was used to compare the change in HbA1c as a function of time (included using restricted cubic splines), the interaction between time and intervention arm, baseline A1c and whether PT-SP live together (stratification variables), baseline insulin use, age, vital hunger, and preferred language.||1.14|-0.05|0.07
72450812|NCT03812614|144422104|SUPERIORITY||Mean Difference (Final Values)|-0.02||||0.96|TWO_SIDED|95.0|-0.67|0.64|||Mixed Models Analysis||Positive coefficient favors I-DSMES; negative coefficient favors FAM-ACT|Linear mixed model with random intercept and slope was used to compare the change in A1c as a function of time (included using restricted cubic splines), the interaction between time and intervention arm, baseline A1c and whether PT-SP live together (stratification variables), baseline insulin use, age, vital hunger, and preferred language||0.64|-0.67|0.96
72450813|NCT03812614|144422105|SUPERIORITY||Mean Difference (Final Values)|-1.51||||0.55|TWO_SIDED|95.0|-6.4|3.38|||Mixed Models Analysis||Positive coefficient favors I-DSMES; negative coefficient favors FAM-ACT|Change in patient SBP was analyzed in a manner similar to that described for the primary outcome (6-month change in patient A1c).||3.38|-6.40|0.55
72450814|NCT03812614|144422106|SUPERIORITY||Mean Difference (Final Values)|5.74||||0.03|TWO_SIDED|95.0|0.57|10.91|||Mixed Models Analysis||Positive coefficient favors I-DSMES; negative coefficient favors FAM-ACT|Change in patient SBP was analyzed in a manner similar to that described for the primary outcome (6-month change in patient A1c).||10.91|0.57|0.03
72450815|NCT03812614|144422107|SUPERIORITY||Mean Difference (Final Values)|-0.29||||0.76|TWO_SIDED|95.0|-2.15|1.58|||Mixed Models Analysis||Positive coefficient favors I-DSMES; negative coefficient favors FAM-ACT|Change in patient diabetes distress was analyzed in a manner similar to that described for the primary outcome (6-month change in patient A1c).||1.58|-2.15|0.76
72450816|NCT03812614|144422108|SUPERIORITY||Mean Difference (Final Values)|-0.32||||0.72|TWO_SIDED|95.0|-2.11|1.46|||Mixed Models Analysis||Positive coefficient favors I-DSMES; negative coefficient favors FAM-ACT|Change in patient diabetes distress was analyzed in a manner similar to that described for the primary outcome (6-month change in patient A1c).||1.46|-2.11|0.72
72450817|NCT03812614|144422109|SUPERIORITY||Mean Difference (Final Values)|-0.23||||0.38|TWO_SIDED|95.0|-0.76|0.29|||Mixed Models Analysis||Positive coefficient favors I-DSMES; negative coefficient favors FAM-ACT|Change in patient health eating was analyzed in a manner similar to that described for the primary outcome (6-month change in patient A1c).||0.29|-0.76|0.38
72450818|NCT03812614|144422110|SUPERIORITY||Mean Difference (Final Values)|-0.18||||0.7|TWO_SIDED|95.0|-1.11|0.74|||Mixed Models Analysis||Positive coefficient favors FAM-ACT; negative coefficient favors I-DSMES|Change in patient physical activity was analyzed in a manner similar to that described for the primary outcome (6-month change in patient A1c).||0.74|-1.11|0.70
72619763|NCT02191397|144770624|OTHER||Mean Difference (Final Values)|0.0||||0.714|TWO_SIDED|95.0|-0.14|0.2||Analysis included Baseline HAMD-17 depressed mood subscale score as covariate, treatment, gender, visit and treatment-visit interaction as fixed effects. Unstructured covariance matrix was used.|Mixed model repeated measures analysis||Comparison for Week 8. OC dataset was used, where available data at a given time point was used with no missing values filled in with estimates.|||0.20|-0.14|0.714
72619764|NCT02191397|144770625|OTHER||Mean Difference (Final Values)|-0.2||||0.358|TWO_SIDED|95.0|-0.5|0.18||Analysis included Baseline HAMD-17 anxiety/somatization subscale score as covariate, treatment, gender, visit and treatment-visit interaction as fixed effects. Unstructured covariance matrix was used.|Mixed model repeated measures analysis||Comparison for Week 1. OC dataset was used, where available data at a given time point was used with no missing values filled in with estimates.|||0.18|-0.50|0.358
72450819|NCT03812614|144422111|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.75|TWO_SIDED|95.0|-0.53|0.74|||Mixed Models Analysis||Positive coefficient favors FAM-ACT; negative coefficient favors I-DSMES|Change in patient diabetes medication adherence was analyzed in a manner similar to that described for the primary outcome (6-month change in patient A1c).||0.74|-0.53|0.75
72450820|NCT03812614|144422111|SUPERIORITY||Mean Difference (Final Values)|-0.04||||0.94|TWO_SIDED|95.0|-0.98|0.91|||Mixed Models Analysis||Positive coefficient favors FAM-ACT; negative coefficient favors I-DSMES|Change in patient blood pressure medication adherence (days/week meds were taken) was analyzed in a manner similar to that described for the primary outcome (6-month change in patient A1c). Analyses were ITT and thus based on data from all enrolled patients.||0.91|-0.98|0.94
72450821|NCT03812614|144422111|SUPERIORITY||Mean Difference (Final Values)|-0.43||||0.42|TWO_SIDED|95.0|-1.46|0.61|||Mixed Models Analysis||Positive coefficient favors FAM-ACT; negative coefficient favors I-DSMES|Change in patient cholesterol medication adherence (days/week meds were taken) was analyzed in a manner similar to that described for the primary outcome (6-month change in patient A1c). Analyses were ITT and thus based on data from all enrolled patients.||0.61|-1.46|0.42
72619765|NCT02191397|144770625|OTHER||Mean Difference (Final Values)|0.4||||0.081|TWO_SIDED|95.0|-0.04|0.75||Analysis included Baseline HAMD-17 anxiety/somatization subscale score as covariate, treatment, gender, visit and treatment-visit interaction as fixed effects. Unstructured covariance matrix was used.|Mixed model repeated measures analysis||Comparison for Week 2. OC dataset was used, where available data at a given time point was used with no missing values filled in with estimates.|||0.75|-0.04|0.081
72619766|NCT02191397|144770625|OTHER||Mean Difference (Final Values)|0.5||||0.062|TWO_SIDED|95.0|-0.02|0.99||Analysis included Baseline HAMD-17 anxiety/somatization subscale score as covariate, treatment, gender, visit and treatment-visit interaction as fixed effects. Unstructured covariance matrix was used.|Mixed model repeated measures analysis||Comparison for Week 4. OC dataset was used, where available data at a given time point was used with no missing values filled in with estimates.|||0.99|-0.02|0.062
72450822|NCT03812614|144422112|SUPERIORITY||Mean Difference (Final Values)|-0.01||||0.96|TWO_SIDED|95.0|-0.54|0.52|||Mixed Models Analysis||Positive coefficient favors FAM-ACT; negative coefficient favors I-DSMES|Change in patient self-efficacy was analyzed in a manner similar to that described for the primary outcome (6-month change in patient A1c).||0.52|-0.54|0.96
72450823|NCT03812614|144422113|SUPERIORITY||Mean Difference (Final Values)|2.93||||0.4|TWO_SIDED|95.0|-3.92|9.78|||Mixed Models Analysis||Positive coefficient favors FAM-ACT; negative coefficient favors I-DSMES|Change in patient activation was analyzed in a manner similar to that described for the primary outcome (6-month change in patient A1c).||9.78|-3.92|0.40
72450824|NCT03812614|144422114|SUPERIORITY||Mean Difference (Final Values)|0.75||||0.11|TWO_SIDED|95.0|-0.18|1.68|||Mixed Models Analysis||Positive coefficient favors FAM-ACT; negative coefficient favors I-DSMES|Change in patient satisfaction with SP support was analyzed in a manner similar to that described for the primary outcome (6-month change in patient A1c).||1.68|-0.18|0.11
72450825|NCT03812614|144422115|SUPERIORITY||Mean Difference (Final Values)|0.18||||0.34|TWO_SIDED|95.0|-0.19|0.55|||Mixed Models Analysis||Positive coefficient favors FAM-ACT; negative coefficient favors I-DSMES|Change in patient perception of supportive and non-supportive behaviors was analyzed in a manner similar to that described for the primary outcome (6-month change in patient A1c).||0.55|-0.19|0.34
72450826|NCT03812614|144422117|SUPERIORITY||Mean Difference (Final Values)|-0.72||||0.47|TWO_SIDED|95.0|-2.67|1.23|||Mixed Models Analysis||Positive coefficient favors I-DSMES; negative coefficient favors FAM-ACT|Support Persons (SPs) were surveyed twice, once at baseline and again at the end of their participation in the study. For SPs enrolled before the start of the COVID-19 pandemic (n=77), the follow-up survey was conducted at 12 months. Due to factors related to the pandemic, the length of the protocol was reduced from 12 to 6 months. Thus, SPs enrolled after the pandemic started (n=145) received their follow-up survey at 6 months, and 6-month change was used for predetermined SP outcomes.||1.23|-2.67|0.47
72450827|NCT03812614|144422118|SUPERIORITY||Mean Difference (Final Values)|-0.25||||0.35|TWO_SIDED|95.0|-0.78|0.27|||Mixed Models Analysis||Positive coefficient favors FAM-ACT; negative coefficient favors I-DSMES|Support Persons (SPs) were surveyed twice, once at baseline and again at the end of their participation in the study. For SPs enrolled before the start of the COVID-19 pandemic (n=77), the follow-up survey was conducted at 12 months. Due to factors related to the pandemic, the length of the protocol was reduced from 12 to 6 months. Thus, SPs enrolled after the pandemic started (n=145) received their follow-up survey at 6 months, and 6-month change was used for predetermined SP outcomes.||0.27|-0.78|0.35
72450828|NCT03812614|144422119|SUPERIORITY||Mean Difference (Final Values)|-0.49||||0.06|TWO_SIDED|95.0|-1.0|0.01|||Mixed Models Analysis||Positive coefficient favors FAM-ACT; negative coefficient favors I-DSMES|Change in patient healthy eating was analyzed in a manner similar to that described for the primary outcome (6-month change in patient A1c).||0.01|-1.00|0.06
72450829|NCT03812614|144422120|SUPERIORITY||Median Difference (Final Values)|-0.34||||0.45|TWO_SIDED|95.0|-1.22|0.54|||Mixed Models Analysis||Positive coefficient favors FAM-ACT; negative coefficient favors I-DSMES|||0.54|-1.22|0.45
72450830|NCT03812614|144422121|SUPERIORITY||Mean Difference (Final Values)|-0.26||||0.4|TWO_SIDED|95.0|-0.86|0.35|||Mixed Models Analysis||Positive coefficient favors FAM-ACT; negative coefficient favors I-DSMES|Change in patient diabetes medication adherence was analyzed in a manner similar to that described for the primary outcome (6-month change in patient A1c).||0.35|-0.86|0.40
72450831|NCT03812614|144422121|SUPERIORITY||Mean Difference (Final Values)|-0.01||||0.98|TWO_SIDED|95.0|-0.9|0.88|||Mixed Models Analysis||Positive coefficient favors FAM-ACT; negative coefficient favors I-DSMES|Change in patient blood pressure medication adherence (days/week meds were taken) was analyzed in a manner similar to that described for the primary outcome (6month change in patient A1c). Analyses were ITT and thus based on data from all enrolled patients.||0.88|-0.90|0.98
72450832|NCT03812614|144422121|SUPERIORITY||Mean Difference (Final Values)|-0.41||||0.43|TWO_SIDED|95.0|-1.42|0.61|||Mixed Models Analysis||Positive coefficient favors FAM-ACT; negative coefficient favors I-DSMES|Change in patient cholesterol medication adherence (days/week meds were taken) was analyzed in a manner similar to that described for the primary outcome (6month change in patient A1c). Analyses were ITT and thus based on data from all enrolled patients.||0.61|-1.42|0.43
72450833|NCT03812614|144422122|SUPERIORITY||Mean Difference (Final Values)|-0.49||||0.06|TWO_SIDED|95.0|-1.0|0.01|||Mixed Models Analysis||Positive coefficient favors FAM-ACT; negative coefficient favors I-DSMES|||0.01|-1.00|0.06
72450834|NCT03812614|144422123|SUPERIORITY||Mean Difference (Final Values)|-0.37||||0.92|TWO_SIDED|95.0|-7.22|6.49|||Mixed Models Analysis||Positive coefficient favors FAM-ACT; negative coefficient favors I-DSMES|Change in patient activation was analyzed in a manner similar to that described for the primary outcome (6-month change in patient A1c).||6.49|-7.22|0.92
72498990|NCT00348140|144528174|SUPERIORITY||Mean Difference (Net)|7.0||||0.389|TWO_SIDED|95.0|-8.9|22.9|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|Q2 Week 36||22.9|-8.9|0.389
72498991|NCT00348140|144528174|SUPERIORITY||Mean Difference (Net)|-1.2||||0.865|TWO_SIDED|95.0|-15.0|12.6|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|Q2 Week 36||12.6|-15.0|0.865
72498992|NCT00348140|144528174|SUPERIORITY||Mean Difference (Net)|4.2||||0.596|TWO_SIDED|95.0|-11.3|19.6|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|Q2 Week 48||19.6|-11.3|0.596
72498993|NCT00348140|144528174|SUPERIORITY||Mean Difference (Net)|-0.2||||0.975|TWO_SIDED|95.0|-14.7|14.2|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|Q2 Week 48||14.2|-14.7|0.975
72498994|NCT00348140|144528175|SUPERIORITY||Mean Difference (Net)|-2.4||||0.043|TWO_SIDED|95.0|-4.7|-0.1|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|Thermometer score Week 12||-0.1|-4.7|0.043
72561923|NCT01958060|144654794|SUPERIORITY_OR_OTHER||Slope|1.5629|STANDARD_ERROR_OF_MEAN|0.1056|||TWO_SIDED|95.0|1.3426|1.7833|||||Dose proportionality was explored using the linear regression model.The perfect dose proportionality would correspond to a slope β of 1. PK endpoints on the log-transformed scale.Standard error of the mean is actually the standard error of the slope.|This was non confirmatory testing (Single dose). Dose proportionality of BI 1034020 following iv administration of single rising doses of 5 mg, 10 mg, 20 mg and 50 mg for AUClast was analysed.||1.7833|1.3426|
72561924|NCT02304406|144654817|OTHER||Odds Ratio (OR)|1.85||||0.1304|TWO_SIDED|95.0|0.8|4.77|||Cochran-Mantel-Haenszel|||||4.77|0.80|0.1304
72561925|NCT02304406|144654818|OTHER|||||||0.6422|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.6422
72561926|NCT02304406|144654819|OTHER|||||||0.4524|||||||Cochran-Mantel-Haenszel|||||||0.4524
72561927|NCT02304406|144654820|OTHER|||||||0.901|||||||Cochran-Mantel-Haenszel|||||||0.9010
72561928|NCT02304406|144654821|OTHER|||||||0.9067|||||||Cochran-Mantel-Haenszel|||||||0.9067
72561929|NCT02304406|144654822|OTHER|||||||0.8785|||||||Cochran-Mantel-Haenszel|||||||0.8785
72561930|NCT02304406|144654823|OTHER|||||||0.9231|||||||Cochran-Mantel-Haenszel|||||||0.9231
72561931|NCT02304406|144654824|OTHER|||||||0.978|||||||Cochran-Mantel-Haenszel|||||||0.9780
72561932|NCT02304406|144654825|OTHER|||||||0.1144|||||||Cochran-Mantel-Haenszel|||||||0.1144
72561933|NCT02304406|144654826|OTHER|||||||0.0862|||||||Cochran-Mantel-Haenszel|||||||0.0862
72561934|NCT02304406|144654827|OTHER|||||||0.0294|||||||Cochran-Mantel-Haenszel|||||||0.0294
72561935|NCT02304406|144654828|OTHER|||||||0.6877|||||||Cochran-Mantel-Haenszel|||||||0.6877
72561936|NCT04284553|144654831|SUPERIORITY||Odds Ratio (OR)|1.2|||||TWO_SIDED|95.0|0.97|1.49|||||"The Odds Ratio compares having open encounter as an intervention factor in the arm the patients' primary care providers were assigned to vs. all others not having an open encounter alert in the arm they were assigned to."|Outcomes were evaluated using generalized linear mixed models with a logit link and binary errors, evaluating the association between the intervention factors (i.e., behavioral components) and the primary outcome, pooling across both stages of the trial and adjusting for provider-level clustering.||1.49|0.97|
72619767|NCT02191397|144770625|OTHER||Mean Difference (Final Values)|0.4||||0.118|TWO_SIDED|95.0|-0.1|0.85||Analysis included Baseline HAMD-17 anxiety/somatization subscale score as covariate, treatment, gender, visit and treatment-visit interaction as fixed effects. Unstructured covariance matrix was used.|Mixed model repeated measures analysis||Comparison for Week 6. OC dataset was used, where available data at a given time point was used with no missing values filled in with estimates.|||0.85|-0.10|0.118
72450835|NCT03812614|144422124|SUPERIORITY||Mean Difference (Final Values)|1.1||||0.02|TWO_SIDED|95.0|0.21|1.99|||Mixed Models Analysis||Positive coefficient favors FAM-ACT; negative coefficient favors I-DSMES|Change in patient satisfaction with SP support was analyzed in a manner similar to that described for the primary outcome (6-month change in patient A1c).||1.99|0.21|0.02
72450836|NCT03812614|144422125|SUPERIORITY||Mean Difference (Final Values)|0.34||||0.06|TWO_SIDED|95.0|-0.01|0.7|||Mixed Models Analysis||Positive coefficient favors FAM-ACT; negative coefficient favors I-DSMES|Change in patient perception of supportive and non-supportive behaviors was analyzed in a manner similar to that described for the primary outcome (6-month change in patient A1c).||0.70|-0.01|0.06
72450837|NCT03812614|144422126|SUPERIORITY||Mean Difference (Final Values)|1.19||||0.49|TWO_SIDED|95.0|-2.19|4.57|||Mixed Models Analysis|||Support Persons (SPs) were surveyed twice, once at baseline and again at the end of their participation in the study. For SPs enrolled before the start of the COVID-19 pandemic (n=77), the follow-up survey was conducted at 12 months. Due to factors related to the pandemic, the length of the protocol was reduced from 12 to 6 months. Thus, SPs enrolled after the pandemic started (n=145) received their follow-up survey at 6 months, and 6-month change was used for predetermined SP outcomes.|Positive coefficient favors I-DSMES; negative coefficient favors FAM-ACT|4.57|-2.19|0.49
72450838|NCT03812614|144422127|SUPERIORITY||Mean Difference (Final Values)|0.78||||0.08|TWO_SIDED|95.0|-0.09|1.66|||Mixed Models Analysis||Positive coefficient favors FAM-ACT; negative coefficient favors I-DSMES|Support Persons (SPs) were surveyed twice, once at baseline and again at the end of their participation in the study. For SPs enrolled before the start of the COVID-19 pandemic (n=77), the follow-up survey was conducted at 12 months. Due to factors related to the pandemic, the length of the protocol was reduced from 12 to 6 months. Thus, SPs enrolled after the pandemic started (n=145) received their follow-up survey at 6 months, and 6-month change was used for predetermined SP outcomes.||1.66|-0.09|0.08
72450839|NCT04763772|144422150|SUPERIORITY||Mean Difference (Final Values)|-4.5||||0.2|TWO_SIDED|95.0|-14.0|4.8|||Regression, Linear|||||4.8|-14|0.2
72450840|NCT04675034|144422151|SUPERIORITY||Combined estimate for LS mean|-0.15|STANDARD_ERROR_OF_MEAN|0.416||0.36|TWO_SIDED|95.0|-0.968|0.67|||ANCOVA|Least Square (LS) mean and treatment group difference with associated 95% confidence intervals (CIs) are modelled using ANCOVA on imputed data.||||0.670|-0.968|0.360
72450841|NCT04675034|144422151|SUPERIORITY||Combined estimate for LS mean|-0.8|STANDARD_ERROR_OF_MEAN|0.418||0.029|TWO_SIDED|95.0|-1.619|0.027|||ANCOVA|Least Square mean and treatment group difference with associated 95% CIs are modelled using ANCOVA on imputed data.||||0.027|-1.619|0.029
72450842|NCT04675034|144422151|SUPERIORITY||Combined estimate for LS mean|-0.8|STANDARD_ERROR_OF_MEAN|0.413||0.026|TWO_SIDED|95.0|-1.618|0.009|||ANCOVA|Least Square mean and treatment group difference with associated 95% CIs are modelled using ANCOVA on imputed data.||||0.009|-1.618|0.026
72450843|NCT04675034|144422151|SUPERIORITY||Combined estimate for LS mean|-0.59|STANDARD_ERROR_OF_MEAN|0.424||0.083|TWO_SIDED|95.0|-1.423|0.245|||ANCOVA|Least Square mean and treatment group difference with associated 95% CIs are modelled using ANCOVA on imputed data.||||0.245|-1.423|0.083
72450844|NCT04163991|144422181|SUPERIORITY||Least Squares (LS) Mean Difference|-0.84|STANDARD_ERROR_OF_MEAN|0.38||0.0296|TWO_SIDED|90.0|-1.47|-0.21||Results are from MMRM analysis with treatment, visit, visit by treatment interaction, and baseline DAS28-CRP score included in the model.|MMRM||LS Mean difference is VIB4920 minus placebo. Differences less than 0 favor VIB4920.|||-0.21|-1.47|0.0296
72450845|NCT04163991|144422181|SUPERIORITY||LS Mean Difference|-0.81|STANDARD_ERROR_OF_MEAN|0.38||0.0355|TWO_SIDED|90.0|-1.44|-0.18||Results are from MMRM analysis with treatment, visit, visit by treatment interaction, and baseline DAS28-CRP score included in the model.|MMRM||LS Mean difference is VIB4920 minus placebo. Differences less than 0 favor VIB4920.|||-0.18|-1.44|0.0355
72450846|NCT04163991|144422181|SUPERIORITY||LS Mean Difference|-0.81|STANDARD_ERROR_OF_MEAN|0.38||0.0364|TWO_SIDED|90.0|-1.44|-0.18||Results are from MMRM analysis with treatment, visit, visit by treatment interaction, and baseline DAS28-CRP score included in the model.|MMRM||LS Mean difference is VIB4920 minus placebo. Differences less than 0 favor VIB4920.|||-0.18|-1.44|0.0364
72450847|NCT04163991|144422181|SUPERIORITY||LS Mean Difference|-0.77|STANDARD_ERROR_OF_MEAN|0.38||0.0478|TWO_SIDED|90.0|-1.41|-0.13||Results are from MMRM analysis with treatment, visit, visit by treatment interaction, and baseline DAS28-CRP score included in the model.|MMRM||LS Mean difference is VIB4920 minus placebo. Differences less than 0 favor VIB4920.|||-0.13|-1.41|0.0478
72450848|NCT04163991|144422192|SUPERIORITY||Ratio of geometric mean versus placebo|0.64||||0.0584|TWO_SIDED|90.0|0.43|0.94||Results are from MMRM analysis on log(ratio to baseline) with treatment, visit, visit by treatment interaction, and log(baseline) included in the model.|MMRM||Ratio of geometric mean is for VIB4920:placebo. Ratios less than 1 indicate a decrease.|||0.94|0.43|0.0584
72450849|NCT04163991|144422192|OTHER||Ratio of geometric mean versus placebo|0.76||||0.2274|TWO_SIDED|90.0|0.51|1.11||Results are from MMRM analysis on log(ratio to baseline) with treatment, visit, visit by treatment interaction, and log(baseline) included in the model.|MMRM||Ratio of geometric mean is for VIB4920:placebo. Ratios less than 1 indicate a decrease.|||1.11|0.51|0.2274
72619768|NCT02191397|144770625|OTHER||Mean Difference (Final Values)|0.3||||0.252|TWO_SIDED|95.0|-0.19|0.71||Analysis included Baseline HAMD-17 anxiety/somatization subscale score as covariate, treatment, gender, visit and treatment-visit interaction as fixed effects. Unstructured covariance matrix was used.|Mixed model repeated measures analysis||Comparison for Week 8. OC dataset was used, where available data at a given time point was used with no missing values filled in with estimates.|||0.71|-0.19|0.252
72450850|NCT04163991|144422192|SUPERIORITY||Ratio of geometric mean versus placebo|0.77||||0.2794|TWO_SIDED|90.0|0.52|1.14||Results are from MMRM analysis on log(ratio to baseline) with treatment, visit, visit by treatment interaction, and log(baseline) included in the model.|MMRM||Ratio of geometric mean is for VIB4920:placebo. Ratios less than 1 indicate a decrease.|||1.14|0.52|0.2794
72450851|NCT04163991|144422192|SUPERIORITY||Ratio of geometric mean versus placebo|0.57||||0.0199|TWO_SIDED|90.0|0.39|0.85||Results are from MMRM analysis on log(ratio to baseline) with treatment, visit, visit by treatment interaction, and log(baseline) included in the model.|MMRM||Ratio of geometric mean is for VIB4920:placebo. Ratios less than 1 indicate a decrease.|||0.85|0.39|0.0199
72450852|NCT04163991|144422193|SUPERIORITY||Ratio of geometric mean versus placebo|0.64||||0.0007|TWO_SIDED|90.0|0.52|0.79||Results are from MMRM analysis on log(ratio to baseline) with treatment, visit, visit by treatment interaction, and log(baseline) included in the model.|MMRM||Ratio of geometric mean is for VIB4920:placebo. Ratios less than 1 indicate a decrease.|||0.79|0.52|0.0007
72450853|NCT04163991|144422193|SUPERIORITY||Ratio of geometric mean versus placebo|0.62||||0.0003|TWO_SIDED|90.0|0.5|0.76||Results are from MMRM analysis on log(ratio to baseline) with treatment, visit, visit by treatment interaction, and log(baseline) included in the model.|MMRM||Ratio of geometric mean is for VIB4920:placebo. Ratios less than 1 indicate a decrease.|||0.76|0.50|0.0003
72450854|NCT04163991|144422193|SUPERIORITY||Ratio of geometric mean versus placebo|0.6||||0.0001|TWO_SIDED|90.0|0.48|0.74||Results are from MMRM analysis on log(ratio to baseline) with treatment, visit, visit by treatment interaction, and log(baseline) included in the model.|MMRM||Ratio of geometric mean is for VIB4920:placebo. Ratios less than 1 indicate a decrease.|||0.74|0.48|0.0001
72450855|NCT04163991|144422193|SUPERIORITY||Ratio of geometric mean versus placebo|0.47|||<|0.0001|TWO_SIDED|90.0|0.38|0.59||Results are from MMRM analysis on log(ratio to baseline) with treatment, visit, visit by treatment interaction, and log(baseline) included in the model.|MMRM||Ratio of geometric mean is for VIB4920:placebo. Ratios less than 1 indicate a decrease.|||0.59|0.38|< 0.0001
72619769|NCT02191397|144770626|OTHER||Mean Difference (Final Values)|0.1||||0.573|TWO_SIDED|95.0|-0.2|0.35||Analysis included Baseline HAMD-17 Retardation subscale score as covariate, treatment, gender, visit and treatment-visit interaction as fixed effects. Unstructured covariance matrix was used.|Mixed model repeated measures analysis||Comparison for Week 1. OC dataset was used, where available data at a given time point was used with no missing values filled in with estimates.|||0.35|-0.20|0.573
72619770|NCT02191397|144770626|OTHER||Mean Difference (Final Values)|0.2||||0.209|TWO_SIDED|95.0|-0.13|0.58||Analysis included Baseline HAMD-17 Retardation subscale score as covariate, treatment, gender, visit and treatment-visit interaction as fixed effects. Unstructured covariance matrix was used.|Mixed model repeated measures analysis||Comparison for Week 2. OC dataset was used, where available data at a given time point was used with no missing values filled in with estimates.|||0.58|-0.13|0.209
72450856|NCT04163991|144422194|SUPERIORITY||Odds Ratio (OR)|1.4||||0.775|TWO_SIDED|90.0|0.2|8.0||Results are from logistic regression analysis with treatment and baseline DAS28-CRP score included in the model.|Regression, Logistic||Odds ratio is VIB4920/placebo, with associated 90% CI and p-value. Odds ratios greater than 1 favor VIB4920.|||8.0|0.2|0.7750
72450857|NCT04163991|144422194|SUPERIORITY||Odds Ratio (OR)|0.6||||0.6974|TWO_SIDED|90.0|0.1|5.5||Results are from logistic regression analysis with treatment and baseline DAS28-CRP score included in the model.|Regression, Logistic||(Lower limit of 90% CI is \< 0.1.) Odds ratio is VIB4920/placebo, with associated 90% CI and p-value. Odds ratios greater than 1 favor VIB4920.|||5.5|0.1|0.6974
72498995|NCT00348140|144528175|SUPERIORITY||Mean Difference (Net)|-2.2||||0.056|TWO_SIDED|95.0|-4.5|0.1|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|Thermometer score Week 12||0.1|-4.5|0.056
72498996|NCT00348140|144528175|SUPERIORITY||Mean Difference (Net)|-0.4||||0.758|TWO_SIDED|95.0|-2.8|2.1|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|Thermometer score Week 36||2.1|-2.8|0.758
72498997|NCT00348140|144528175|SUPERIORITY||Mean Difference (Net)|-2.0||||0.109|TWO_SIDED|95.0|-4.5|0.5|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|Thermometer score Week 36||0.5|-4.5|0.109
72498998|NCT00348140|144528175|SUPERIORITY||Mean Difference (Net)|-2.6||||0.05|TWO_SIDED|95.0|-5.2|0.0|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|Thermometer score Week 48||-0.0|-5.2|0.050
72498999|NCT00348140|144528175|SUPERIORITY||Mean Difference (Net)|-3.4||||0.009|TWO_SIDED|95.0|-6.0|-0.9|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|Thermometer score Week 48||-0.9|-6.0|0.009
72499000|NCT00348140|144528176|SUPERIORITY||Mean Difference (Net)|0.01||||0.662|TWO_SIDED|95.0|-0.02|0.03|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|Ultility score Week 12||0.03|-0.02|0.662
72370349|NCT04413617|144251183|SUPERIORITY||Mean Difference (Final Values)|-0.04|STANDARD_ERROR_OF_MEAN|0.164||0.3933|TWO_SIDED|90.0|-0.32|0.23|||Mixed Model Repeated Measures|||The primary clinical hypothesis is that mean decrease at Week 12 in DAS28-CRP score in one or both combo arms exceeds the mean decrease in the reference (tofacitinib) treatment arm, regardless of occurrence of intercurrent events. The null hypothesis is that the mean decrease in DAS28-CRP score at Week 12 is identical in the control (tofacitinib arm) and combination arms.||0.23|-0.32|0.3933
72450858|NCT04163991|144422194|SUPERIORITY||Odds Ratio (OR)|0.9||||0.9318|TWO_SIDED|90.0|0.1|5.7||Results are from logistic regression analysis with treatment and baseline DAS28-CRP score included in the model.|Regression, Logistic||Odds ratio is VIB4920/placebo, with associated 90% CI and p-value. Odds ratios greater than 1 favor VIB4920.|||5.7|0.1|0.9318
72619771|NCT02191397|144770626|OTHER||Mean Difference (Final Values)|0.2||||0.427|TWO_SIDED|95.0|-0.25|0.58||Analysis included Baseline HAMD-17 Retardation subscale score as covariate, treatment, gender, visit and treatment-visit interaction as fixed effects. Unstructured covariance matrix was used.|Mixed model repeated measures analysis||Comparison for Week 4. OC dataset was used, where available data at a given time point was used with no missing values filled in with estimates.|||0.58|-0.25|0.427
72450859|NCT04163991|144422194|SUPERIORITY||Odds Ratio (OR)|0.9||||0.9108|TWO_SIDED|90.0|0.2|5.1||Results are from logistic regression analysis with treatment and baseline DAS28-CRP score included in the model.|Regression, Logistic||Odds ratio is VIB4920/placebo, with associated 90% CI and p-value. Odds ratios greater than 1 favor VIB4920.|||5.1|0.2|0.9108
72450860|NCT04163991|144422195|SUPERIORITY||Hazard Ratio (HR)|1.04||||0.9805|TWO_SIDED|90.0|0.1|10.6||Based on Cox regression method with treatment group included in the model.|Regression, Cox||Hazard ratio is VIB4920/placebo. Hazard ratios less than 1 favor VIB4920.|||10.60|0.10|0.9805
72450861|NCT04163991|144422195|SUPERIORITY||Hazard Ratio (HR)|1.04||||0.9805|TWO_SIDED|90.0|0.1|10.6||Based on Cox regression method with treatment group included in the model.|Regression, Cox||Hazard ratio is VIB4920/placebo. Hazard ratios less than 1 favor VIB4920.|||10.60|0.10|0.9805
72450862|NCT04163991|144422195|SUPERIORITY||Hazard Ratio (HR)|3.01||||0.3407|TWO_SIDED|90.0|0.45|20.09||Based on Cox regression method with treatment group included in the model.|Regression, Cox||Hazard ratio is VIB4920/placebo. Hazard ratios less than 1 favor VIB4920.|||20.09|0.45|0.3407
72450863|NCT04163991|144422195|SUPERIORITY||Hazard Ratio (HR)|1.04||||0.9805|TWO_SIDED|90.0|0.1|10.6||Based on Cox regression method with treatment group included in the model.|Regression, Cox||Hazard ratio is VIB4920/placebo. Hazard ratios less than 1 favor VIB4920.|||10.60|0.10|0.9805
72450864|NCT03735979|144422241|SUPERIORITY||Posterior Mean Difference (Final Values)|-1.51|STANDARD_DEVIATION|0.51||0.002|TWO_SIDED|||||"The P-value is the posterior probability that study drug has a higher benefit than control. The a priori threshold for a successful trial is 0.985.~The posterior probability that argatroban was better than placebo was 0.002."|Bayesian|Primary analysis compared treatment group with placebo, with adjustment for baseline NIHSS score in a Bayesian normal dynamic linear model.|The posterior mean of study treatment minus placebo.|||||0.002
72450865|NCT03735979|144422241|SUPERIORITY||Posterior Mean Difference (Final Values)|-0.5|STANDARD_DEVIATION|0.29||0.04|TWO_SIDED|||||"The P-value is the posterior probability that study drug has a higher benefit than control. The a priori threshold for a successful trial is 0.985.~The posterior probability that eptifibitide was better than placebo was 0.04."|Bayesian|Primary analysis compared treatment group with placebo, with adjustment for baseline NIHSS score in a Bayesian normal dynamic linear model.|The posterior mean of study treatment minus placebo.|||||0.04
72450866|NCT05654662|144422265|SUPERIORITY|||||||0.0032|||||||MMRM|||Change from Baseline at Week 12 (Test for non-zero within group change from Baseline)||||0.0032
72450867|NCT05654662|144422266|SUPERIORITY||Adjusted Mean Difference|-6.6|STANDARD_ERROR_OF_MEAN|2.03||0.0013|TWO_SIDED|95.0|-10.6|-2.6|||Mixed Model with Repeated Measure (MMRM)||Adjusted mean difference was calculated as test product minus reference product.|||-2.6|-10.6|0.0013
72619772|NCT02191397|144770626|OTHER||Mean Difference (Final Values)|0.0||||0.851|TWO_SIDED|95.0|-0.4|0.48||Analysis included Baseline HAMD-17 Retardation subscale score as covariate, treatment, gender, visit and treatment-visit interaction as fixed effects. Unstructured covariance matrix was used.|Mixed model repeated measures analysis||Comparison for Week 6. OC dataset was used, where available data at a given time point was used with no missing values filled in with estimates.|||0.48|-0.40|0.851
72450868|NCT05654662|144422267|SUPERIORITY|||||||0.0181|||||||MMRM|||Change from Baseline at Week 3 (Test for non-zero within group change from Baseline)||||0.0181
72450869|NCT05654662|144422267|SUPERIORITY|||||||0.0541|||||||MMRM|||Change from Baseline at Week 6 (Test for non-zero within group change from Baseline)||||0.0541
72450870|NCT05654662|144422268|SUPERIORITY||Adjusted Mean Difference|-3.8|STANDARD_ERROR_OF_MEAN|1.44||0.0091|TWO_SIDED|95.0|-6.7|-1.0|||MMRM||Adjusted mean difference was calculated as test product minus reference product.|Change from Baseline at Week 3||-1.0|-6.7|0.0091
72499001|NCT00348140|144528176|SUPERIORITY||Mean Difference (Net)|-0.01||||0.503|TWO_SIDED|95.0|-0.03|0.02|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|Ultility score Week 12||0.02|-0.03|0.503
72499002|NCT00348140|144528176|SUPERIORITY||Mean Difference (Net)|0.0||||0.892|TWO_SIDED|95.0|-0.03|0.03|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|Utility score Week 36||0.03|-0.03|0.892
72450871|NCT05654662|144422268|SUPERIORITY||Adjusted Mean Difference|-5.3|STANDARD_ERROR_OF_MEAN|1.78||0.0031|TWO_SIDED|95.0|-8.8|-1.8|||MMRM||Adjusted mean difference was calculated as test product minus reference product.|Change from Baseline at Week 6||-1.8|-8.8|0.0031
72450872|NCT05654662|144422269|SUPERIORITY||||||<|0.0001|||||||MMRM|||Change from Baseline at Week 3 (Test for non-zero within group change from Baseline)||||<0.0001
72450873|NCT05654662|144422269|SUPERIORITY||||||<|0.0001|||||||MMRM|||Change from Baseline at Week 6 (Test for non-zero within group change from Baseline)||||<0.0001
72619773|NCT02191397|144770626|OTHER||Mean Difference (Final Values)|0.2||||0.37|TWO_SIDED|95.0|-0.25|0.66||Analysis included Baseline HAMD-17 Retardation subscale score as covariate, treatment, gender, visit and treatment-visit interaction as fixed effects. Unstructured covariance matrix was used.|Mixed model repeated measures analysis||Comparison for Week 8. OC dataset was used, where available data at a given time point was used with no missing values filled in with estimates.|||0.66|-0.25|0.370
72450874|NCT05654662|144422269|SUPERIORITY||||||<|0.0001|||||||MMRM|||Change from Baseline at Week 12 (Test for non-zero within group change from Baseline)||||<0.0001
72450875|NCT05654662|144422270|SUPERIORITY||Adjusted Mean Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.011||0.0051|TWO_SIDED|95.0|-0.05|-0.01|||MMRM||Adjusted mean difference was calculated as test product minus reference product.|Change from Baseline at Week 3||-0.01|-0.05|0.0051
72450876|NCT05654662|144422270|SUPERIORITY||Adjusted Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.013||0.0034|TWO_SIDED|95.0|-0.07|-0.01|||MMRM||Adjusted mean difference was calculated as test product minus reference product.|Change from Baseline at Week 6||-0.01|-0.07|0.0034
72450877|NCT05654662|144422270|SUPERIORITY||Adjusted Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.015||0.0022|TWO_SIDED|95.0|-0.08|-0.02|||MMRM||Adjusted mean difference was calculated as test product minus reference product.|Change from Baseline at Week 12||-0.02|-0.08|0.0022
72450878|NCT05654662|144422271|SUPERIORITY||||||<|0.0001|||||||MMRM|||Change from Baseline at Week 3 (Test for non-zero within group change from Baseline)||||<0.0001
72450879|NCT05654662|144422271|SUPERIORITY||||||<|0.0001|||||||MMRM|||Change from Baseline at Week 6 (Test for non-zero within group change from Baseline)||||<0.0001
72450880|NCT05654662|144422271|SUPERIORITY||||||<|0.0001|||||||MMRM|||Change from Baseline at Week 12 (Test for non-zero within group change from Baseline)||||<0.0001
72450881|NCT05654662|144422272|SUPERIORITY||Adjusted Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001|TWO_SIDED|95.0|-0.12|-0.04|||MMRM||Adjusted mean difference was calculated as test product minus reference product.|Change from Baseline at Week 3||-0.04|-0.12|<0.0001
72450882|NCT05654662|144422272|SUPERIORITY||Adjusted Mean Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.027|<|0.0001|TWO_SIDED|95.0|-0.18|-0.07|||MMRM||Adjusted mean difference was calculated as test product minus reference product.|Change from Baseline at Week 6||-0.07|-0.18|<0.0001
72450883|NCT05654662|144422272|SUPERIORITY||Adjusted Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.03|<|0.0001|TWO_SIDED|95.0|-0.2|-0.08|||MMRM||Adjusted mean difference was calculated as test product minus reference product.|Change from Baseline at Week 12||-0.08|-0.20|<0.0001
72450884|NCT05654662|144422273|SUPERIORITY||||||<|0.0001|||||||MMRM|||Change from Baseline at Week 3 (Test for non-zero within group change from Baseline)||||<0.0001
72450885|NCT05654662|144422273|SUPERIORITY||||||<|0.0001|||||||MMRM|||Change from Baseline at Week 6 (Test for non-zero within group change from Baseline)||||<0.0001
72450886|NCT05654662|144422273|SUPERIORITY||||||<|0.0001|||||||MMRM|||Change from Baseline at Week 12 (Test for non-zero within group change from Baseline)||||<0.0001
72450887|NCT05654662|144422274|SUPERIORITY||Adjusted Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.047||0.0012|TWO_SIDED|95.0|-0.25|-0.06|||MMRM||Adjusted mean difference was calculated as test product minus reference product.|Change from Baseline at Week 3||-0.06|-0.25|0.0012
72619774|NCT02191397|144770627|OTHER||Mean Difference (Final Values)|0.1||||0.438|TWO_SIDED|95.0|-0.16|0.37||Analysis included Baseline HAMD-17 Sleep Disorder subscale score as covariate, treatment, gender, visit and treatment-visit interaction as fixed effects. Unstructured covariance matrix was used.|Mixed model repeated measures analysis||Comparison for Week 1. OC dataset was used, where available data at a given time point was used with no missing values filled in with estimates.|||0.37|-0.16|0.438
72450888|NCT05654662|144422274|SUPERIORITY||Adjusted Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.061||0.0058|TWO_SIDED|95.0|-0.29|-0.05|||MMRM||Adjusted mean difference was calculated as test product minus reference product.|Change from Baseline at Week 6||-0.05|-0.29|0.0058
72450889|NCT05654662|144422274|SUPERIORITY||Adjusted Mean Difference|-0.29|STANDARD_ERROR_OF_MEAN|0.066|<|0.0001|TWO_SIDED|95.0|-0.42|-0.16|||MMRM||Adjusted mean difference was calculated as test product minus reference product.|Change from Baseline at Week 12||-0.16|-0.42|<0.0001
72450890|NCT05654662|144422275|SUPERIORITY||||||<|0.0001|||||||MMRM|||Change from Baseline at Week 3 (Test for non-zero within group change from Baseline)||||<0.0001
72450891|NCT05654662|144422275|SUPERIORITY||||||<|0.0001|||||||MMRM|||Change from Baseline at Week 6 (Test for non-zero within group change from Baseline)||||<0.0001
72450892|NCT05654662|144422275|SUPERIORITY||||||<|0.0001|||||||MMRM|||Change from Baseline at Week 12 (Test for non-zero within group change from Baseline)||||<0.0001
72450893|NCT05654662|144422276|SUPERIORITY||Adjusted Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.051||0.0022|TWO_SIDED|95.0|-0.26|-0.06|||MMRM||Adjusted mean difference was calculated as test product minus reference product.|Change from Baseline at Week 3||-0.06|-0.26|0.0022
72450894|NCT05654662|144422276|SUPERIORITY||Adjusted Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.066||0.0099|TWO_SIDED|95.0|-0.3|-0.04|||MMRM||Adjusted mean difference was calculated as test product minus reference product.|Change from Baseline at Week 6||-0.04|-0.30|0.0099
72450895|NCT05654662|144422276|SUPERIORITY||Adjusted Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.073|<|0.0001|TWO_SIDED|95.0|-0.45|-0.16|||MMRM||Adjusted mean difference was calculated as test product minus reference product.|Change from Baseline at Week 12||-0.16|-0.45|<0.0001
72450896|NCT04499521|144422301|OTHER||Median Difference (Final Values)|0.12|||||TWO_SIDED|95.0|-0.27|0.5||||||Mean difference between Gauze and Gel ARM A Bladder D2cc||0.50|-0.27|
72450897|NCT04499521|144422301|OTHER||Median Difference (Final Values)|0.01|||||TWO_SIDED|95.0|-0.94|0.96||||||Mean difference between Gauze and Gel ARM B Bladder D2cc||0.96|-0.94|
72450898|NCT04499521|144422301|OTHER||Mean Difference (Final Values)|-0.19|||||TWO_SIDED|95.0|-0.54|0.16||||||Mean difference between Gauze and Gel ARM A Rectum D2cc||0.16|-0.54|
72370350|NCT02657408|144251193|EQUIVALENCE|confirmatory statistical hypothesis tested|Geometric mean ratio (%)|1.27||||0.3043|TWO_SIDED|90.0|0.86|1.87|||ANOVA|||The statistical model used for the primary analysis of primary endpoints was an ANOVA model on the logarithmic scale. This model included the effect 'treatment'.||1.87|0.86|0.3043
72450899|NCT04499521|144422301|OTHER||Mean Difference (Final Values)|-0.19|||||TWO_SIDED|95.0|-0.67|0.29||||||Mean difference between Gauze and Gel ARM B Rectum D2cc||0.29|-0.67|
72450900|NCT05525104|144422304|SUPERIORITY|||||||0.041|||||||Wilcoxon (Mann-Whitney)|||||||0.041
72450901|NCT05525104|144422305|SUPERIORITY|||||||0.066|||||||Wilcoxon (Mann-Whitney)|||||||0.066
72450902|NCT05525104|144422309|SUPERIORITY|||||||0.001|||||||t-test, 2 sided|||||||0.001
72469737|NCT02201901|144463157|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Binomial test|P-value is from the 2-sided exact 1-sample binomial test for the superiority of SOF/VEL+RBV 12 weeks (Group 2) over prespecified rate of 1%.||A sample size of 75 participants per treatment group would provide over 99% power to detect 40% improvement in SVR12 rate from the assumed spontaneous rate of 1% or less using a 2-sided exact 1-sample binomial test at significance level of 0.0167.||||<0.001
72450903|NCT03990883|144422310|NON_INFERIORITY|"The hypothesis to be tested was: H0: pA-pB ≤ d0 versus H1: pA-pB \> d0 where, pA is the response rate for Princess® FILLER Lidocaine, pB is the response rate for the Comparator, and d0 is the non-inferiority margin set at -10%. The hypothesis was tested using a 1-sided, McNemar type test at an alpha of 0.025 with a delta of 0.10 (10%).~Assuming pA to be 87% and pB to be 88% a sample size of 222 subjects had been calculated to be sufficient to achieve a power of 90%."|Risk Difference (RD)|0.37|||<|0.0001|TWO_SIDED|95.0|-2.96|3.7|||McNemar|||||3.7|-2.96|<0.0001
72450904|NCT03990883|144422311|NON_INFERIORITY|"The hypothesis to be tested was: H0: pA-pB ≤ d0 versus H1: pA-pB \> d0 where, pA is the response rate for Princess® FILLER Lidocaine, pB is the response rate for the Comparator, and d0 is the non-inferiority margin set at -10%. The hypothesis was tested using a 1-sided, McNemar type test at an alpha of 0.025 with a delta of 0.10 (10%).~Assuming pA to be 87% and pB to be 88% a sample size of 222 subjects had been calculated to be sufficient to achieve a power of 90%."|Risk Difference (RD)|0.0|||<|0.0001|TWO_SIDED|95.0|-3.71|3.71||The threshold for statistical significance is 0.025. A hierarchical approach is used and results are confirmative if all tests previously performed within the hierarchy achieve significance at a one-sided significance level of 0.025.|McNemar|||||3.71|-3.71|<0.0001
72450905|NCT03990883|144422312|NON_INFERIORITY|"The hypothesis to be tested was: H0: pA-pB ≤ d0 versus H1: pA-pB \> d0 where, pA is the response rate for Princess® FILLER Lidocaine, pB is the response rate for the Comparator, and d0 is the non-inferiority margin set at -10%. The hypothesis was tested using a 1-sided, McNemar type test at an alpha of 0.025 with a delta of 0.10 (10%).~Assuming pA to be 87% and pB to be 88% a sample size of 222 subjects had been calculated to be sufficient to achieve a power of 90%."|Risk Difference (RD)|-2.96||||0.025|TWO_SIDED|95.0|-9.99|4.07||The threshold for statistical significance is 0.025. A hierarchical approach is used and results are confirmative if all tests previously performed within the hierarchy achieve significance at a one-sided significance level of 0.025.|McNemar|||||4.07|-9.99|0.025
72450906|NCT03990883|144422313|NON_INFERIORITY|"The hypothesis to be tested was: H0: pA-pB ≤ d0 versus H1: pA-pB \> d0 where, pA is the response rate for Princess® FILLER Lidocaine, pB is the response rate for the Comparator, and d0 is the non-inferiority margin set at -10%. The hypothesis was tested using a 1-sided, McNemar type test at an alpha of 0.025 with a delta of 0.10 (10%).~Assuming pA to be 87% and pB to be 88% a sample size of 222 subjects had been calculated to be sufficient to achieve a power of 90%."|Risk Difference (RD)|-0.45||||0.009|TWO_SIDED|95.0|-8.42|7.52||The threshold for statistical significance is 0.025. A hierarchical approach is used and results are confirmative if all tests previously performed within the hierarchy achieve significance at a one-sided significance level of 0.025.|McNemar|||||7.52|-8.42|0.009
72450907|NCT03990883|144422314|NON_INFERIORITY|"The hypothesis to be tested was: H0: pA-pB ≤ d0 versus H1: pA-pB \> d0 where, pA is the response rate for Princess® FILLER Lidocaine, pB is the response rate for the Comparator, and d0 is the non-inferiority margin set at -10%. The hypothesis was tested using a 1-sided, McNemar type test at an alpha of 0.025 with a delta of 0.10 (10%).~Assuming pA to be 87% and pB to be 88% a sample size of 222 subjects had been calculated to be sufficient to achieve a power of 90%."|Risk Difference (RD)|-0.37|||<|0.0001|TWO_SIDED|95.0|-3.85|3.11||The threshold for statistical significance is 0.025. A hierarchical approach is used and results are confirmative if all tests previously performed within the hierarchy achieve significance at a one-sided significance level of 0.025.|McNemar|||||3.11|-3.85|<0.0001
72450908|NCT03990883|144422315|NON_INFERIORITY|"The hypothesis to be tested was: H0: pA-pB ≤ d0 versus H1: pA-pB \> d0 where, pA is the response rate for Princess® FILLER Lidocaine, pB is the response rate for the Comparator, and d0 is the non-inferiority margin set at -10%. The hypothesis was tested using a 1-sided, McNemar type test at an alpha of 0.025 with a delta of 0.10 (10%).~Assuming pA to be 87% and pB to be 88% a sample size of 222 subjects had been calculated to be sufficient to achieve a power of 90%."|Risk Difference (RD)|-0.45|||<|0.0001|TWO_SIDED|95.0|-4.05|3.16||The threshold for statistical significance is 0.025. A hierarchical approach is used and results are confirmative if all tests previously performed within the hierarchy achieve significance at a one-sided significance level of 0.025.|McNemar|||||3.16|-4.05|<0.0001
72391272|NCT03000439|144289781|OTHER||Difference in LS Mean|-0.07|||||TWO_SIDED|95.0|-0.65|0.5||||||DB week 32: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open-Label baseline value, and Open-Label baseline value by visit interaction.||0.50|-0.65|
72450909|NCT05247034|144422340|OTHER||||||>|0.05|||||||t-test, 2 sided|||"Comparing row Change from baseline at Week 12"||||>0.05
72450910|NCT05247034|144422340|OTHER|||||||0.0001|||||||Wilcoxon (Mann-Whitney)|||||||0.0001
72450911|NCT05247034|144422340|OTHER|||||||0.0125|||||||Wilcoxon (Mann-Whitney)|||||||0.0125
72450912|NCT05247034|144422341|OTHER||||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||For 1 Hz||||>0.05
72499003|NCT00348140|144528176|SUPERIORITY||Mean Difference (Net)|-0.03||||0.083|TWO_SIDED|95.0|-0.05|0.0|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|Utility score Week 36||0.00|-0.05|0.083
72391273|NCT03000439|144289781|OTHER||Difference in LS Mean|0.06|||||TWO_SIDED|95.0|-0.51|0.63||||||DB week 36: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open-Label baseline value, and Open-Label baseline value by visit interaction.||0.63|-0.51|
72450913|NCT05247034|144422341|OTHER||||||>|0.05|||||||t-test, 2 sided|||5 and 10 Hz||||>0.05
72450914|NCT05247034|144422341|OTHER||||||>|0.05|||||||t-test, 2 sided|||For 1, 5 and 10 Hz||||>0.05
72450915|NCT05247034|144422341|OTHER||||||>|0.05|||||||t-test, 2 sided|||For 1, 5 and 10 Hz||||>0.05
72450916|NCT05247034|144422342|OTHER||||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||"Comparing row Change from baseline at Week 12"||||>0.05
72450917|NCT05247034|144422342|OTHER|||||||0.042|||||||Friedman|||||||0.042
72450918|NCT05247034|144422342|OTHER|||||||0.015|||||||Friedman|||||||0.015
72450919|NCT05247034|144422343|OTHER||||||>|0.05|||||||Z Test|||||||>0.05
72450920|NCT05247034|144422343|OTHER||||||>|0.05|||||||Z Test|||||||>0.05
72450921|NCT05247034|144422343|OTHER||||||>|0.05|||||||Z Test|||||||>0.05
72450922|NCT05247034|144422344|OTHER||||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||"Comparing row Change from baseline at Week 12"||||>0.05
72450923|NCT05247034|144422344|OTHER||||||>|0.05|||||||ANOVA|||||||>0.05
72391274|NCT03000439|144289781|OTHER||Difference in LS Mean|-0.04|||||TWO_SIDED|95.0|-0.55|0.47||||||DB week 40: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open-Label baseline value, and Open-Label baseline value by visit interaction.||0.47|-0.55|
72391275|NCT03000439|144289781|OTHER||Difference in LS Mean|-0.16|||||TWO_SIDED|95.0|-0.82|0.5||||||DB week 44: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open-Label baseline value, and Open-Label baseline value by visit interaction.||0.50|-0.82|
72391276|NCT03000439|144289781|OTHER||Difference in LS Mean|-0.14|||||TWO_SIDED|95.0|-1.51|1.22||||||DB week 48: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open-Label baseline value, and Open-Label baseline value by visit interaction.||1.22|-1.51|
72391277|NCT03000439|144289781|OTHER||Difference in LS Mean|-0.08|||||TWO_SIDED|95.0|-1.05|0.88||||||DB week 52: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open-Label baseline value, and Open-Label baseline value by visit interaction.||0.88|-1.05|
72391278|NCT03000439|144289782|OTHER||Difference in LS Mean|0.49|||||TWO_SIDED|95.0|-0.32|1.3||||||DB at Week 4: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||1.30|-0.32|
72391279|NCT03000439|144289782|OTHER||Difference in LS Mean|0.48|||||TWO_SIDED|95.0|-0.64|1.61||||||DB at Week 8: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||1.61|-0.64|
72391280|NCT03000439|144289782|OTHER||Difference in LS Mean|0.03|||||TWO_SIDED|95.0|-1.02|1.07||||||DB at Week 12: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||1.07|-1.02|
72391281|NCT03000439|144289782|OTHER||Difference in LS Mean|0.23|||||TWO_SIDED|95.0|-0.69|1.14||||||DB at Week 16: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||1.14|-0.69|
72391282|NCT03000439|144289782|OTHER||Difference in LS Mean|0.09|||||TWO_SIDED|95.0|-1.05|1.22||||||DB at Week 20: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||1.22|-1.05|
72391283|NCT03000439|144289782|OTHER||Difference in LS Mean|0.28|||||TWO_SIDED|95.0|-0.6|1.16||||||DB at Week 24: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||1.16|-0.60|
72391284|NCT03000439|144289782|OTHER||Difference in LS Mean|0.02|||||TWO_SIDED|95.0|-1.6|1.64||||||DB at Week 28: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||1.64|-1.60|
72391285|NCT03000439|144289782|OTHER||Difference in LS Mean|0.02|||||TWO_SIDED|95.0|-1.6|1.64||||||DB at Week 32: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||1.64|-1.60|
72391286|NCT03000439|144289782|OTHER||Difference in LS Mean|0.07|||||TWO_SIDED|95.0|-0.58|0.73||||||DB at Week 36: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||0.73|-0.58|
72391287|NCT03000439|144289782|OTHER||Difference in LS Mean|0.06|||||TWO_SIDED|95.0|-0.53|0.65||||||DB at Week 40: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||0.65|-0.53|
72619775|NCT02191397|144770627|OTHER||Mean Difference (Final Values)|0.4||||0.014|TWO_SIDED|95.0|0.07|0.66||Analysis included Baseline HAMD-17 Sleep Disorder subscale score as covariate, treatment, gender, visit and treatment-visit interaction as fixed effects. Unstructured covariance matrix was used.|Mixed model repeated measures analysis||Comparison for Week 2. OC dataset was used, where available data at a given time point was used with no missing values filled in with estimates.|||0.66|0.07|0.014
72391288|NCT03000439|144289782|OTHER||Difference in LS Mean|-0.12|||||TWO_SIDED|95.0|-0.87|0.64||||||DB at Week 44: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||0.64|-0.87|
72391289|NCT03000439|144289782|OTHER||Difference in LS Mean|0.21|||||TWO_SIDED|95.0|-1.13|1.54||||||DB at Week 48: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||1.54|-1.13|
72450924|NCT05247034|144422344|OTHER||||||>|0.05|||||||ANOVA|||||||>0.05
72391290|NCT03000439|144289782|OTHER||Difference in LS Mean|0.05|||||TWO_SIDED|95.0|-1.0|1.11||||||DB at Week 52: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||1.11|-1.00|
72391291|NCT03000439|144289785|OTHER||Difference in LS Mean|6.0|||||TWO_SIDED|95.0|-8.35|20.36||||||CHQ01-Global Health Subscale Standardized Score; DB Week 24: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||20.36|-8.35|
72391292|NCT03000439|144289785|OTHER||Difference in LS Mean|2.85|||||TWO_SIDED|95.0|-12.43|18.14||||||CHQ01-Global Health Subscale Standardized Score; DB Week 48: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||18.14|-12.43|
72391293|NCT03000439|144289785|OTHER||Difference in LS Mean|-4.19|||||TWO_SIDED|95.0|-15.78|7.4||||||CHQ01-Physical Functioning Subscale Standardized Score; DB Week 24: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||7.40|-15.78|
72450925|NCT05247034|144422345|OTHER||||||>|0.05|||||||t-test, 2 sided|||"Comparing row Change from baseline at Week 12"||||>0.05
72450926|NCT05247034|144422345|OTHER||||||>|0.05|||||||ANOVA|||||||>0.05
72450927|NCT05247034|144422345|OTHER||||||>|0.05|||||||ANOVA|||||||>0.05
72450928|NCT05247034|144422346|OTHER||||||>|0.05|||||||t-test, 2 sided|||"Comparing row Change from baseline at Week 12"||||>0.05
72450929|NCT05247034|144422346|OTHER||||||>|0.05|||||||ANOVA|||||||>0.05
72450930|NCT05247034|144422346|OTHER||||||>|0.05|||||||ANOVA|||||||>0.05
72450931|NCT05247034|144422347|OTHER||||||>|0.05|||||||t-test, 2 sided|||"Comparing row Change from baseline at Week 12"||||>0.05
72450932|NCT05247034|144422347|OTHER||||||>|0.05|||||||ANOVA|||||||>0.05
72450933|NCT05247034|144422347|OTHER||||||>|0.05|||||||ANOVA|||||||>0.05
72450934|NCT05247034|144422348|OTHER||||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||"Comparing row Change from baseline at Week 12"||||>0.05
72450935|NCT05247034|144422348|OTHER||||||>|0.05|||||||ANOVA|||||||>0.05
72450936|NCT05247034|144422348|OTHER||||||>|0.05|||||||Friedman|||||||>0.05
72450937|NCT05247034|144422349|OTHER||||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||"Comparing row Change from baseline at Week 12"||||>0.05
72450938|NCT05247034|144422349|OTHER||||||>|0.05|||||||ANOVA|||||||>0.05
72450939|NCT05247034|144422349|OTHER||||||>|0.05|||||||Friedman|||||||>0.05
72450940|NCT05247034|144422350|OTHER||||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||"Comparing row Change from baseline at Week 12"||||>0.05
72450941|NCT05247034|144422350|OTHER||||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||||||>0.05
72370351|NCT02657408|144251194|EQUIVALENCE|No statistical hypothesis tested|Geometric mean ratio (%)|1.01|||||TWO_SIDED|90.0|0.88|1.16||||||The statistical model used for the analysis was an ANOVA model on the logarithmic scale. This model included the effect 'treatment'.||1.16|0.88|
72450942|NCT05247034|144422350|OTHER|||||||0.0027|||||||Wilcoxon (Mann-Whitney)|||||||0.0027
72370352|NCT02657408|144251195|EQUIVALENCE|No statistical hypothesis tested|Geometric mean ratio (%)|1.54|||||TWO_SIDED|90.0|0.59|4.03||||||The statistical model used for the primary analysis of primary endpoints was an ANOVA model on the logarithmic scale. This model included the effect 'treatment'.||4.03|0.59|
72370353|NCT02657408|144251196|EQUIVALENCE|No statistical hypothesis tested|Geometric mean ratio (%)|1.17|||||TWO_SIDED|90.0|0.49|2.85||||||The statistical model used for the analysis was an ANOVA model on the logarithmic scale. This model included the effect 'treatment'.||2.85|0.49|
72370354|NCT02657408|144251197|EQUIVALENCE|No statistical hypothesis tested|Geometric mean ratio (%)|1.29|||||TWO_SIDED|90.0|0.91|1.83||||||The statistical model used for the primary analysis of primary endpoints was an ANOVA model on the logarithmic scale. This model included the effect 'treatment'.||1.83|0.91|
72370355|NCT02657408|144251198|EQUIVALENCE|No statistical hypothesis tested|Geometric mean ratio (%)|1.03|||||TWO_SIDED|90.0|0.9|1.18||||||The statistical model used for the analysis was an ANOVA model on the logarithmic scale. This model included the effect 'treatment'.||1.18|0.90|
72370356|NCT02657408|144251199|EQUIVALENCE|No statistical hypothesis tested|Geometric mean ratio (%)|1.18|||||TWO_SIDED|90.0|0.91|1.53||||||The statistical model used for the primary analysis of primary endpoints was an ANOVA model on the logarithmic scale. This model included the effect 'treatment'.||1.53|0.91|
72370357|NCT02657408|144251200|EQUIVALENCE|No statistical hypothesis tested|Geometric mean ratio (%)|0.94|||||TWO_SIDED|90.0|0.8|1.09||||||The statistical model used for the analysis was an ANOVA model on the logarithmic scale. This model included the effect 'treatment'.||1.09|0.80|
72370358|NCT02657408|144251201|EQUIVALENCE|No statistical hypothesis tested|Geometric mean ratio (%)|0.81|||||TWO_SIDED|90.0|0.51|1.28||||||The statistical model used for the primary analysis of primary endpoints was an ANOVA model on the logarithmic scale. This model included the effect 'treatment'.||1.28|0.51|
72370359|NCT02657408|144251202|EQUIVALENCE|No statistical hypothesis tested|Geometric mean ratio (%)|0.64|||||TWO_SIDED|90.0|0.43|0.97||||||The statistical model used for the analysis was an ANOVA model on the logarithmic scale. This model included the effect 'treatment'.||0.97|0.43|
72370360|NCT03530124|144251267|SUPERIORITY|The number of infants with ≥1 apneic event for each group and compared using a Mantel-Haenszel statistic in a stratified analysis by study site and gestational age group (\< 28 weeks versus ≥ 28 weeks) to control for the randomization blocks at the two-sided alpha 0.05 level and corresponding 95% confidence interval for the occurrence of apnea.|Odds Ratio (OR)|2.7||||0.0104|TWO_SIDED|95.0|1.27|5.73|||Mantel Haenszel||No adjustments were made to the alpha level (two-sided alpha=0.05) for the primary objective.|||5.73|1.27|0.0104
72370361|NCT03530124|144251268|OTHER|The number of apnea events were compared using a linear regression model (assuming a Poisson distribution) with study site and gestational age group covariates to control for the randomization blocks.||||||0.11|||||||Regression, Linear|No adjustments were made to the alpha level (two-sided alpha=0.05) for the secondary objectives.||||||0.11
72370362|NCT03530124|144251269|OTHER|Average duration of apnea episodes between groups were compared using a mixed effects model with a random intercept for each infant with one or more events and study site and gestational age group as covariates to control for the randomization blocks.||||||0.36|||||||Mixed Effects Model|No adjustments were made to the alpha level (two-sided alpha=0.05) for the secondary objectives.||||||0.36
72370363|NCT03530124|144251270|SUPERIORITY|The proportion of infants requiring an increase in respiratory support for each group were compared using a Mantel-Haenszel statistic in a stratified analysis by study site and gestational age group to control for the randomization blocks at the two-sided alpha 0.05 level and corresponding 95% confidence interval for the occurrence of apnea.|Odds Ratio (OR)|2.07||||0.3555|TWO_SIDED|95.0|0.59|7.23|||Mantel Haenszel||No adjustments were made to the alpha level (two-sided alpha=0.05) for the secondary objectives.|||7.23|0.59|0.3555
72370364|NCT03530124|144251271|SUPERIORITY|The proportion of infants with ≥1 cardiorespiratory event using a Mantel-Haenszel statistic in at the two-sided alpha 0.05 level and corresponding 95% confidence interval.|Odds Ratio (OR)|0.89||||1|TWO_SIDED|95.0|0.29|2.77|||Mantel Haenszel||No adjustments were made to the alpha level (two-sided alpha=0.05) for the secondary objectives.|Only Duke University had viable monitoring data to analyze this compound outcome objective.||2.77|0.29|1.0000
72370365|NCT03530124|144251272|SUPERIORITY||Odds Ratio (OR)|1.93||||1|TWO_SIDED|95.0|0.17|21.63|||Mantel Haenszel||No adjustments were made to the alpha level (two-sided alpha=0.05) for the secondary objectives.|The proportion of infants requiring positive pressure ventilation for each group were compared using a Mantel-Haenszel statistic in a stratified analysis by study site and gestational age group to control for the randomization blocks at the two-sided alpha 0.05 level and corresponding 95% confidence interval for the occurrence of apnea during the 48-hour monitoring period.||21.63|0.17|1.0000
72370366|NCT00356304|144251352|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANCOVA|||||||<.05
72561937|NCT04284553|144654831|SUPERIORITY||Odds Ratio (OR)|1.15|||||TWO_SIDED|95.0|0.83|1.59|||||"The OR compares between having boostering as an intervention factor in the arm the patients' primary care providers were assigned to vs. all others not having boostering in the arm they were assigned to."|Outcomes were evaluated using generalized linear mixed models with a logit link and binary errors, evaluating the association between the intervention factors (i.e., behavioral components) and the primary outcome, pooling across both stages of the 2-stage Atrius adaptive trial and adjusting for provider-level clustering. As noted in our Study Protocol and pre-specified, the analyses are conducted across the intervention factors across the study arms, rather than between the study arms.||1.59|0.83|
72561938|NCT04284553|144654831|SUPERIORITY||Odds Ratio (OR)|0.84|||||TWO_SIDED|95.0|0.61|1.16|||||"The OR compares between having cold-state priming as an intervention factor in the arm the patient's primary care providers were assigned to vs. all others not having cold-state priming in the arm they were assigned to."|Outcomes were evaluated using generalized linear mixed models with a logit link and binary errors, evaluating the association between the intervention factors (i.e., behavioral components) and the primary outcome, pooling across both stages of the 2-stage Atrius adaptive trial and adjusting for provider-level clustering. As noted in our Study Protocol and pre-specified, the analyses are conducted across the intervention factors across the study arms, rather than between the study arms.||1.16|0.61|
72391294|NCT03000439|144289785|OTHER||Difference in LS Mean|2.31|||||TWO_SIDED|95.0|-37.06|41.68||||||CHQ01-Physical Functioning Subscale Standardized Score; DB Week 48: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||41.68|-37.06|
72450943|NCT05247034|144422351|OTHER||||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||"Comparing row Change from baseline at Week 12"||||>0.05
72450944|NCT05247034|144422351|OTHER||||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||||||>0.05
72450945|NCT05247034|144422351|OTHER|||||||0.043|||||||Wilcoxon (Mann-Whitney)|||||||0.0430
72450946|NCT05247034|144422352|OTHER||||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||"Comparing row Change from baseline at Week 12"||||>0.05
72450947|NCT05247034|144422352|OTHER||||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||||||>0.05
72450948|NCT05247034|144422352|OTHER||||||>|0.05|||||||t-test, 2 sided|||||||>0.05
72450949|NCT05247034|144422353|OTHER||||||>|0.05|||||||t-test, 2 sided|||"Comparing row Change from baseline at Week 12"||||>0.05
72450950|NCT05247034|144422353|OTHER||||||>|0.05|||||||t-test, 2 sided|||||||>0.05
72450951|NCT05247034|144422353|OTHER||||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||||||>0.05
72450952|NCT05247034|144422354|OTHER||||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||"Comparing row Change from baseline at Week 12"||||>0.05
72450953|NCT05247034|144422354|OTHER||||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||||||>0.05
72450954|NCT05247034|144422354|OTHER||||||>|0.05|||||||t-test, 2 sided|||||||>0.05
72450955|NCT05247034|144422355|OTHER||||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||"Comparing row Change from baseline at Week 12"||||>0.05
72450956|NCT05247034|144422355|OTHER||||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||||||>0.05
72450957|NCT05247034|144422355|OTHER||||||>|0.05|||||||t-test, 2 sided|||||||>0.05
72450958|NCT05247034|144422356|OTHER||||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||"Comparing row Change from baseline at Week 12"||||>0.05
72450959|NCT05247034|144422356|OTHER||||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||||||>0.05
72450960|NCT05247034|144422356|OTHER||||||>|0.05|||||||t-test, 2 sided|||||||>0.05
72450961|NCT05247034|144422357|OTHER||||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||"Comparing row Change from baseline at Week 12"||||>0.05
72450962|NCT05247034|144422357|OTHER|||||||0.0007|||||||Wilcoxon (Mann-Whitney)|||||||0.0007
72450963|NCT05247034|144422357|OTHER||||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||||||>0.05
72450964|NCT06356285|144422409|EQUIVALENCE|Quasibinominal models were used as the outcomes are bounded count variables. Accepting a two-sided p-value adjusted for 3 comparisons, the study was designed with 80% power to detect a minimal detectable effect size between the trial arms and control for the primary outcome.|Odds Ratio, log|0.05||||0.017|TWO_SIDED|95.0||||A two-sided p-value, as shown in the table, which was adjusted for 3 comparisons|Quasibinominal regression|||||||0.017
72450965|NCT03884101|144422488|SUPERIORITY||Hazard Ratio (HR)|1.01||||0.5550121|TWO_SIDED|95.0|0.83|1.24|||Log Rank|One-sided p-value based on log-rank test and stratified by ECOG performance status and prior chemotherapy and/or chemoradiation.|Based on Cox regression model with Efron's method for tie handling with treatment as a covariate stratified by ECOG performance status and prior chemotherapy and/or chemoradiation.|||1.24|0.83|0.5550121
72450966|NCT03884101|144422489|SUPERIORITY||Hazard Ratio (HR)|0.92||||0.1792058|TWO_SIDED|95.0|0.77|1.1|||Log Rank|One-sided p-value based on log-rank test and stratified by MMR status, ECOG performance status, and prior chemotherapy and/or chemoradiation.|Based on Cox regression model with Efron's method for tie handling with treatment as a covariate stratified by MMR status, ECOG performance status, and prior chemotherapy and/or chemoradiation.|||1.10|0.77|0.1792058
72450967|NCT03884101|144422490|NON_INFERIORITY|The null hypothesis for the non-inferiority test was that the hazard ratio was equal to 1.1.|Hazard Ratio (HR)|1.02||||0.2459875|TWO_SIDED|95.0|0.83|1.26|||Log Rank|One-sided p-value based on log-rank test and stratified by ECOG performance status and prior chemotherapy and/or chemoradiation.|Based on Cox regression model with Efron's method for tie handling with treatment as a covariate stratified by ECOG performance status and prior chemotherapy and/or chemoradiation.|||1.26|0.83|0.2459875
72450968|NCT03884101|144422490|SUPERIORITY||Hazard Ratio (HR)|1.02||||0.5875597|TWO_SIDED|95.0|0.83|1.26|||Log Rank|One-sided p-value based on log-rank test and stratified by ECOG performance status and prior chemotherapy and/or chemoradiation.|Based on Cox regression model with Efron's method for tie handling with treatment as a covariate stratified by ECOG performance status and prior chemotherapy and/or chemoradiation.|||1.26|0.83|0.5875597
72391295|NCT03000439|144289785|OTHER||Difference in LS Mean|-5.47|||||TWO_SIDED|95.0|-17.37|6.43||||||CHQ01-Social Limitations: Emotional Subscale Standardized Score; DB Week 24: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||6.43|-17.37|
72391296|NCT03000439|144289785|OTHER||Difference in LS Mean|6.82|||||TWO_SIDED|95.0|-20.92|34.57||||||CHQ01-Social Limitations: Emotional Subscale Standardized Score; DB Week 48: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||34.57|-20.92|
72450969|NCT03884101|144422491|SUPERIORITY||Hazard Ratio (HR)|0.93||||0.21552|TWO_SIDED|95.0|0.77|1.12|||Log Rank|One-sided p-value based on log-rank test and stratified by MMR status, ECOG performance status, and prior chemotherapy and/or chemoradiation.|Based on Cox regression model with Efron's method for tie handling with treatment as a covariate stratified by MMR status, ECOG performance status, and prior chemotherapy and/or chemoradiation.|||1.12|0.77|0.21552
72450970|NCT03884101|144422492|OTHER||Difference in Percentage|-4.2||||0.8569|TWO_SIDED|95.0|-11.9|3.5|||Stratified Miettinen & Nurminen|One-sided p-value for testing. H0: difference in % = 0 versus H1: difference in % \> 0.|Based on Miettinen \& Nurminen method stratified by ECOG performance status and prior chemotherapy and/or chemoradiation.|||3.5|-11.9|0.8569
72450971|NCT03884101|144422493|OTHER||Difference in Percentage|0.0||||0.4999|TWO_SIDED|95.0|-6.7|6.7|||Stratified Miettinen & Nurminen|One-sided p-value for testing. H0: difference in % = 0 versus H1: difference in % \> 0.|Based on Miettinen \& Nurminen method stratified by MMR status, ECOG performance status, and prior chemotherapy and/or chemoradiation.|||6.7|-6.7|0.4999
72450972|NCT03884101|144422494|OTHER|Based on a cLDA model with the PRO scores as the response variable with covariates for treatment by study visit interaction, and stratification factors ECOG performance status, and prior chemotherapy and/or chemoradiation.|Difference in Least Square Means|-3.77||||0.0302|TWO_SIDED|95.0|-7.17|-0.36|||cLDA model|||||-0.36|-7.17|0.0302
72450973|NCT03884101|144422495|OTHER|Based on a cLDA model with the PRO scores as the response variable with covariates for treatment by study visit interaction, and stratification factors MMR status, ECOG performance status, and prior chemotherapy and/or chemoradiation.|Difference in Least Square Means|-2.29||||0.1355|TWO_SIDED|95.0|-5.31|0.72|||cLDA model|||||0.72|-5.31|0.1355
72561939|NCT04284553|144654831|SUPERIORITY||Odds Ratio (OR)|1.2|||||TWO_SIDED|95.0|0.88|1.64|||||"The OR compares between having simplification as an intervention factor in the arm the patients' primary care providers were assigned to vs. all others not having simplification in the arm they were assigned to."|Outcomes were evaluated using generalized linear mixed models with a logit link and binary errors, evaluating the association between the intervention factors (i.e., behavioral components) and the primary outcome, pooling across both stages of the 2-stage Atrius adaptive trial and adjusting for provider-level clustering. As noted in our Study Protocol and pre-specified, the analyses are conducted across the intervention factors across the study arms, rather than between the study arms.||1.64|0.88|
72561940|NCT04284553|144654831|SUPERIORITY||Odds Ratio (OR)|0.71|||||TWO_SIDED|95.0|0.52|0.98|||||"The OR compares between having sign-off approval as an intervention factor in the arm the patients' primary care providers were assigned to vs. all others not having sign-off approval in the arm they were assigned to."|Outcomes were evaluated using generalized linear mixed models with a logit link and binary errors, evaluating the association between the intervention factors (i.e., behavioral components) and the primary outcome, pooling across both stages of the 2-stage Atrius adaptive trial and adjusting for provider-level clustering. As noted in our Study Protocol and pre-specified, the analyses are conducted across the intervention factors across the study arms, rather than between the study arms.||0.98|0.52|
72561941|NCT04284553|144654831|SUPERIORITY||Odds Ratio (OR)|1.21|||||TWO_SIDED|95.0|0.89|1.64|||||"The OR compares between having pre-commitment as an intervention factor in the arm the patients' primary care providers were assigned to vs. all others not having pre-commitment in the arm they were assigned to."|Outcomes were evaluated using generalized linear mixed models with a logit link and binary errors, evaluating the association between the intervention factors (i.e., behavioral components) and the primary outcome, pooling across both stages of the 2-stage Atrius adaptive trial and adjusting for provider-level clustering. As noted in our Study Protocol and pre-specified, the analyses are conducted across the intervention factors across the study arms, rather than between the study arms.||1.64|0.89|
72450974|NCT02938520|144422500|NON_INFERIORITY|Non-inferiority in the proportion of participants with virologic failure at Week 48 (per FDA's snapshot algorithm for assessing HIV-1 RNA \>=50 c/mL) can be concluded if the upper bound of a two-sided 95% confidence interval (CI) for the difference in failure rates between the two treatment arms (CAB - ABC/DTG/3TC) is less than 6%.|Adjusted difference in proportion|-0.4|||||TWO_SIDED|95.0|-2.8|2.1|||||||Adjusted difference in proportion was based on Cochran-Mantel Haenszel stratified analysis adjusting for the following baseline stratification factors: sex at birth (Male, Female) and Induction Baseline (Week -20) HIV-1 RNA (\<100,000 \>=100,000 c/mL)|2.1|-2.8|
72450975|NCT02938520|144422501|NON_INFERIORITY|Non-inferiority in the proportion of participants with HIV-1 RNA\<50 c/mL at Week 48 (per FDA's snapshot algorithm) can be concluded if the lower bound of a two-sided 95% confidence interval for the difference in success rates between the two treatment arms (CAB - ABC/DTG/3TC) is more than -10%|Adjusted difference in proportion|0.4|||||TWO_SIDED|95.0|-3.7|4.5|||||Adjusted difference in proportion was based on Cochran-Mantel Haenszel stratified analysis adjusting for the following baseline stratification factors: sex at birth (Male, Female) and Induction Baseline (Week -20) HIV-1 RNA (\<100,000 \>=100,000 c/mL)|||4.5|-3.7|
72450976|NCT02938520|144422554|OTHER||||||<|0.001||||||Week 41/48 was compared with the 1st visit (Week 5) based on Wilcoxon signed-rank test, respectively. p-values are derived for 'Acceptance' only and not adjusted for multiple testing.|Wilcoxon (Mann-Whitney)|||||||<0.001
72370367|NCT02504216|144251356|SUPERIORITY||Hazard Ratio (HR)|0.85|||=|0.0043|TWO_SIDED|95.0|0.76|0.96|||Log Rank|P-value (1-sided) is based on the log rank test stratified by type of procedure and clopidogrel use per IxRS assignment with treatment as a factor.||IxRS: Interactive web/voice response system||0.96|0.76|=0.0043
72450977|NCT02938520|144422556|OTHER||Adjusted difference|1.2||||0.307|TWO_SIDED|95.0|-1.1|3.6|||ANCOVA||Treatment comparison at Week 24 is presented, adjusted for Maintenance Baseline (Day 1) Score, Induction Baseline (Week -20) HIV-1 RNA (\<100,000, \>=100,000 c/mL), gender at birth, age (\<50, \>= 50 Years) and race (white, non-white).|||3.6|-1.1|0.307
72450978|NCT02938520|144422556|OTHER||Adjusted difference|0.9||||0.472|TWO_SIDED|95.0|-1.5|3.2|||ANCOVA||Treatment comparison at Week 48 is presented, adjusted for Maintenance Baseline (Day 1) Score, Induction Baseline (Week -20) HIV-1 RNA (\<100,000, \>=100,000 c/mL), gender at birth, age (\<50, \>= 50 Years) and race (white, non-white).|||3.2|-1.5|0.472
72561942|NCT04284553|144654831|SUPERIORITY||Odds Ratio (OR)|0.81|||||TWO_SIDED|95.0|0.55|1.19|||||"The OR compares patients having risk framing as an intervention factor in the arm the patients' primary care providers were assigned to vs. all others not having risk framing in the arm they were assigned to."|Outcomes were evaluated using generalized linear mixed models with a logit link and binary errors, evaluating the association between the intervention factors (i.e., behavioral components) and the primary outcome, pooling across both stages of the 2-stage Atrius adaptive trial and adjusting for provider-level clustering. As noted in our Study Protocol and pre-specified, the analyses are conducted across the intervention factors across the study arms, rather than between the study arms.||1.19|0.55|
72561943|NCT04284553|144654833|SUPERIORITY||Mean Difference (Final Values)|1.78|||||TWO_SIDED|95.0|-17.6|21.2|||||"The estimate compares having open encounter as an intervention factor in the arm the patients' primary care providers were assigned to vs. all others not having open encounter in the arm they were assigned to."|Outcomes were evaluated using generalized linear mixed models with an identity link and normally-distributed errors, evaluating the association between the intervention factors (i.e., behavioral components) and secondary outcome, pooling across both stages of the 2-stage Atrius adaptive trial and adjusting for provider-level clustering. As noted in our Study Protocol and pre-specified, the analyses are conducted across intervention factors across study arms, rather than between the study arms.||21.2|-17.6|
72561944|NCT04284553|144654833|SUPERIORITY||Mean Difference (Final Values)|-12.1|||||TWO_SIDED|95.0|-41.8|17.5|||||"The estimate compares having boostering as an intervention factor in the arm the patients' primary care providers were assigned to vs. all others not having boostering in the arm they were assigned to."|Outcomes were evaluated using generalized linear mixed models with an identity link and normally-distributed errors, evaluating the association between the intervention factors (i.e., behavioral components) and secondary outcome, pooling across both stages of the 2-stage Atrius adaptive trial and adjusting for provider-level clustering. As noted in our Study Protocol and pre-specified, the analyses are conducted across intervention factors across study arms, rather than between the study arms.||17.5|-41.8|
72561945|NCT04284553|144654833|SUPERIORITY||Mean Difference (Final Values)|39.5|||||TWO_SIDED|95.0|11.6|67.4|||||"The estimate compares having cold-state priming as an intervention factor in the arm the patients' primary care providers were assigned to vs. all others not having cold-state priming in the arm they were assigned to."|Outcomes were evaluated using generalized linear mixed models with an identity link and normally-distributed errors, evaluating the association between the intervention factors (i.e., behavioral components) and secondary outcome, pooling across both stages of the 2-stage Atrius adaptive trial and adjusting for provider-level clustering. As noted in our Study Protocol and pre-specified, the analyses are conducted across intervention factors across study arms, rather than between the study arms.||67.4|11.6|
72561946|NCT04284553|144654833|SUPERIORITY||Mean Difference (Final Values)|-1.74|||||TWO_SIDED|95.0|-30.4|26.9|||||"The estimate compares having simplification as an intervention factor in the arm the patients' primary care providers were assigned to vs. all others not having simplification in the arm they were assigned to."|Outcomes were evaluated using generalized linear mixed models with an identity link and normally-distributed errors, evaluating the association between the intervention factors (i.e., behavioral components) and secondary outcome, pooling across both stages of the 2-stage Atrius adaptive trial and adjusting for provider-level clustering. As noted in our Study Protocol and pre-specified, the analyses are conducted across intervention factors across study arms, rather than between the study arms.||26.9|-30.4|
72561947|NCT04284553|144654833|SUPERIORITY||Mean Difference (Final Values)|-10.1|||||TWO_SIDED|95.0|-37.6|17.4|||||"The estimate compares having sign-off approval as an intervention factor in the arm the patients' primary care providers were assigned to vs. all others not having sign-off approval in the arm they were assigned to."|Outcomes were evaluated using generalized linear mixed models with an identity link and normally-distributed errors, evaluating the association between the intervention factors (i.e., behavioral components) and secondary outcome, pooling across both stages of the 2-stage Atrius adaptive trial and adjusting for provider-level clustering. As noted in our Study Protocol and pre-specified, the analyses are conducted across intervention factors across study arms, rather than between the study arms.||17.4|-37.6|
72561948|NCT04284553|144654833|SUPERIORITY||Mean Difference (Final Values)|4.2|||||TWO_SIDED|95.0|-24.1|32.5|||||"The estimate compares having pre-commitment as an intervention factor in the arm the patients' primary care providers were assigned to vs. all others not having pre-commitment in the arm they were assigned to."|Outcomes were evaluated using generalized linear mixed models with an identity link and normally-distributed errors, evaluating the association between the intervention factors (i.e., behavioral components) and secondary outcome, pooling across both stages of the 2-stage Atrius adaptive trial and adjusting for provider-level clustering. As noted in our Study Protocol and pre-specified, the analyses are conducted across intervention factors across study arms, rather than between the study arms.||32.5|-24.1|
72619776|NCT02191397|144770627|OTHER||Mean Difference (Final Values)|0.2||||0.207|TWO_SIDED|95.0|-0.11|0.5||Analysis included Baseline HAMD-17 Sleep Disorder subscale score as covariate, treatment, gender, visit and treatment-visit interaction as fixed effects. Unstructured covariance matrix was used.|Mixed model repeated measures analysis||Comparison for Week 4. OC dataset was used, where available data at a given time point was used with no missing values filled in with estimates.|||0.50|-0.11|0.207
72619777|NCT02191397|144770627|OTHER||Mean Difference (Final Values)|0.2||||0.137|TWO_SIDED|95.0|-0.07|0.54||Analysis included Baseline HAMD-17 Sleep Disorder subscale score as covariate, treatment, gender, visit and treatment-visit interaction as fixed effects. Unstructured covariance matrix was used.|Mixed model repeated measures analysis||Comparison for Week 6. OC dataset was used, where available data at a given time point was used with no missing values filled in with estimates.|||0.54|-0.07|0.137
72450979|NCT02938520|144422557|OTHER||Adjusted difference|1.8||||0.116|TWO_SIDED|95.0|-0.4|3.9|||ANCOVA||Treatment comparison at Week 24 is presented, adjusted for Maintenance Baseline (Day 1) Score, Induction Baseline (Week -20) HIV-1 RNA (\<100,000, \>=100,000 c/mL), gender at birth, age (\<50, \>= 50 Years) and race (white, non-white).|||3.9|-0.4|0.116
72450980|NCT02938520|144422557|OTHER||Adjusted difference|0.1||||0.944|TWO_SIDED|95.0|-2.3|2.5|||ANCOVA||Treatment comparison at Week 48 is presented, adjusted for Maintenance Baseline (Day 1) Score, Induction Baseline (Week -20) HIV-1 RNA (\<100,000, \>=100,000 c/mL), gender at birth, age (\<50, \>= 50 Years) and race (white, non-white).|||2.5|-2.3|0.944
72450981|NCT02938520|144422558|OTHER||Adjusted difference|-1.3||||0.552|TWO_SIDED|95.0|-5.7|3.0|||ANCOVA||Treatment comparison at Week 24 is presented, adjusted for Maintenance Baseline (Day 1) Score, Induction Baseline (Week -20) HIV-1 RNA (\<100,000, \>=100,000 c/mL), gender at birth, age (\<50, \>= 50 Years) and race (white, non-white).|||3.0|-5.7|0.552
72450982|NCT02938520|144422558|OTHER||Adjusted difference|-4.6||||0.033|TWO_SIDED|95.0|-8.9|-0.4|||ANCOVA||Treatment comparison at Week 48 is presented, adjusted for Maintenance Baseline (Day 1) Score, Induction Baseline (Week -20) HIV-1 RNA (\<100,000, \>=100,000 c/mL), gender at birth, age (\<50, \>= 50 Years) and race (white, non-white).|||-0.4|-8.9|0.033
72450983|NCT02938520|144422559|OTHER||Adjusted difference|1.021||||0.122|TWO_SIDED|95.0|-0.275|2.318|||ANCOVA||Treatment comparison of SF-12 MCS at Week 24 is presented, adjusted for Maintenance Baseline (Day 1) Score, Induction Baseline (Week -20) HIV-1 RNA (\<100,000, \>=100,000 c/mL), gender at birth, age (\<50, \>= 50 Years) and race (white, non-white).|||2.318|-0.275|0.122
72450984|NCT02938520|144422559|OTHER||Adjusted difference|1.103||||0.109|TWO_SIDED|95.0|-0.248|2.453|||ANCOVA||Treatment comparison of SF-12 MCS at Week 48 is presented, adjusted for Maintenance Baseline (Day 1) Score, Induction Baseline (Week -20) HIV-1 RNA (\<100,000, \>=100,000 c/mL), gender at birth, age (\<50, \>= 50 Years) and race (white, non-white).|||2.453|-0.248|0.109
72450985|NCT02938520|144422559|OTHER||Adjusted difference|0.182||||0.645|TWO_SIDED|95.0|-0.594|0.958|||ANCOVA||Treatment comparison of SF-12 PCS at Week 24 is presented, adjusted for Maintenance Baseline (Day 1) Score, Induction Baseline (Week -20) HIV-1 RNA (\<100,000, \>=100,000 c/mL), gender at birth, age (\<50, \>= 50 Years) and race (white, non-white).|||0.958|-0.594|0.645
72450986|NCT02938520|144422559|OTHER||Adjusted difference|-0.169||||0.689|TWO_SIDED|95.0|-0.994|0.657|||ANCOVA||Treatment comparison of SF-12 PCS at Week 48 is presented, adjusted for Maintenance Baseline (Day 1) Score, Induction Baseline (Week -20) HIV-1 RNA (\<100,000, \>=100,000 c/mL), gender at birth, age (\<50, \>= 50 Years) and race (white, non-white).|||0.657|-0.994|0.689
72450987|NCT02938520|144422560|OTHER||Adjusted difference|2.2|||<|0.001|TWO_SIDED|95.0|1.0|3.4|||ANCOVA||Treatment comparison at Week 24 is presented, adjusted for Maintenance Baseline (Day 1) Score, Induction Baseline (Week -20) HIV-1 RNA (\<100,000, \>=100,000 c/mL), gender at birth, age (\<50, \>= 50 Years) and race (white, non-white).|||3.4|1.0|<0.001
72450988|NCT02938520|144422560|OTHER||Adjusted difference|0.7||||0.217|TWO_SIDED|95.0|-0.4|1.9|||ANCOVA||Treatment comparison at Week 44 is presented, adjusted for Maintenance Baseline (Day 1) Score, Induction Baseline (Week -20) HIV-1 RNA (\<100,000, \>=100,000 c/mL), gender at birth, age (\<50, \>= 50 Years) and race (white, non-white).|||1.9|-0.4|0.217
72450989|NCT02938520|144422561|OTHER||Difference|4.1|||<|0.001|TWO_SIDED|95.0|2.8|5.5|||ANOVA||Treatment comparison of HIVTSQc-total treatment satisfaction score at Week 48 is presented, adjusted for Induction Baseline (Week -20) HIV-1 RNA (\<100,000, \>=100,000 c/mL), gender at birth, age (\<50, \>= 50 Years) and race (white, non-white).|||5.5|2.8|<0.001
72450990|NCT02938520|144422563|OTHER||Adjusted difference|2.2||||0.232|TWO_SIDED|95.0|-1.4|5.7|||ANCOVA||Treatment comparison at Week 8 is presented, adjusted for Maintenance Baseline (Day 1) Score, Induction Baseline (Week -20) HIV-1 RNA (\<100,000, \>=100,000 c/mL), gender at birth, age (\<50, \>= 50 Years) and race (white, non-white).|||5.7|-1.4|0.232
72450991|NCT02938520|144422563|OTHER||Adjusted difference|2.7||||0.154|TWO_SIDED|95.0|-1.0|6.4|||ANCOVA||Treatment comparison Week 24 is presented, adjusted for Maintenance Baseline (Day 1) Score, Induction Baseline (Week -20) HIV-1 RNA (\<100,000, \>=100,000 c/mL), gender at birth, age (\<50, \>= 50 Years) and race (white, non-white).|||6.4|-1.0|0.154
72450992|NCT02938520|144422563|OTHER||Adjusted difference|2.2||||0.236|TWO_SIDED|95.0|-1.4|5.8|||ANCOVA||Treatment comparison at Week 48 is presented, adjusted for Maintenance Baseline (Day 1) Score, Induction Baseline (Week -20) HIV-1 RNA (\<100,000, \>=100,000 c/mL), gender at birth, age (\<50, \>= 50 Years) and race (white, non-white).|||5.8|-1.4|0.236
72450993|NCT06603766|144422567|SUPERIORITY|||||||0.83|||||||Chi-squared|||||||0.83
72450994|NCT06603766|144422568|SUPERIORITY|||||||0.46|||||||Chi-squared|||||||0.46
72450995|NCT06603766|144422569|SUPERIORITY|||||||0.008|||||||Chi-squared|||||||0.008
72450996|NCT06603766|144422570|SUPERIORITY|||||||0.032|||||||Chi-squared|||||||0.032
72450997|NCT06603766|144422571|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
72450998|NCT06603766|144422572|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
72450999|NCT06097494|144422573|SUPERIORITY||Odds Ratio (OR)|1.08|||||TWO_SIDED|95.0|1.01|1.15|||||Calculated as the odds of a person diagnosed with vitiligo having with depression versus people not diagnosed with vitiligo|||1.15|1.01|
72451000|NCT06097494|144422574|SUPERIORITY||Odds Ratio (OR)|1.19|||||TWO_SIDED|95.0|1.09|1.3|||||Calculated as the odds of people diagnosed with vitiligo having anxiety compared to people not diagnosed with vitilligo.|||1.30|1.09|
72451001|NCT06097494|144422575|SUPERIORITY||Odds Ratio (OR)|1.1|||||TWO_SIDED|95.0|1.03|1.17|||||Calculated as the odds of people diagnosed with vitiligo having anxiety or depression compared to people not diagnosed with vitilligo.|||1.17|1.03|
72451002|NCT06097494|144422576|SUPERIORITY||Incidence rate ratio|1.29|||||TWO_SIDED|95.0|1.26|1.32|||||Adjusted incident rate ratio for increased primary care use was calculated by comparing patients with vitiligo versus matched controls not having vitiligo,using negative binomial regression.|||1.32|1.26|
72451003|NCT06097494|144422578|OTHER||Hazard Ratio (HR)|1.06|||||TWO_SIDED|95.0|0.93|1.2|||||Hazard ratios for mental health referrals was calculated using Cox proportional hazards regression model and reflect a comparison of the incidence rates between people diagnosed with vitiligo and people not diagnosed with vitiligo.|||1.20|0.93|
72451004|NCT06097494|144422579|OTHER||Hazard Ratio (HR)|0.93|||||TWO_SIDED|95.0|0.76|1.15|||||Hazard ratios for unemployment was calculated using Cox proportional hazards regression model and reflect a comparison of the incidence rates between people diagnosed with vitiligo and people not diagnosed with vitiligo.|||1.15|0.76|
72451005|NCT06097494|144422580|OTHER||Hazard Ratio (HR)|1.15|||||TWO_SIDED|95.0|1.06|1.24|||||Hazard ratios for time off work was calculated using Cox proportional hazards regression model and reflect a comparison of the incidence rates between people diagnosed with vitiligo and people not diagnosed with vitiligo.|||1.24|1.06|
72451006|NCT06097494|144422581|OTHER||Hazard Ratio (HR)|1.15|||||TWO_SIDED|95.0|1.02|1.31|||||Hazard ratios for sleep disturbance was calculated using Cox proportional hazards regression model and reflect a comparison of the incidence rates between people diagnosed with vitiligo and people not diagnosed with vitiligo.|||1.31|1.02|
72451007|NCT05275556|144422582|SUPERIORITY||Mean Difference (Final Values)|0.14||||0.0002|TWO_SIDED|95.0|0.07|0.23||Threshold for significance is 0.025.|Poisson Regression|||||0.23|0.07|0.0002
72451008|NCT05275556|144422583|NON_INFERIORITY|Non-inferiority margin is -10%.|Mean Difference (Final Values)|-0.06||||0.09|TWO_SIDED|95.0|-0.15|0.03||Threshold for significance is 0.025.|Resampling based|||||0.03|-0.15|0.09
72451009|NCT05275556|144422584|SUPERIORITY||Difference in percentage|5.5||||0.031|TWO_SIDED|95.0|-0.3|11.2|||Cochran-Mantel-Haenszel|Threshold for significance is 0.025.||||11.2|-0.3|0.031
72451010|NCT05275556|144422585|OTHER||rate|0.58|||||TWO_SIDED|||||||||||||
72451011|NCT05275556|144422586|OTHER|2 sided test for differences between arms|Mean Difference (Final Values)|0.58||||0.169|TWO_SIDED||||||Permutation test|||||||0.169
72451012|NCT05275556|144422587|OTHER||||||||||||||||||Descriptive analysis: 52.4 in Colonoscopy (Standard of Care), 59.6 in CAD-e Device|||
72451013|NCT05275556|144422588|SUPERIORITY||Mean Difference (Net)|4.6||||0.0578|TWO_SIDED|95.0|-0.2|9.4||Nominal p-value.|Cochran-Mantel-Haenszel|||Difference in percentage between both arms is reported. H0: Colonoscopy (Standard of Care) percentage \<= CADe Device percentage (i.e. test of superiority)||9.4|-0.2|0.0578
72451014|NCT05275556|144422589|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.7813|TWO_SIDED|95.0|-1.5|2.0||Nominal p-value|Cochran-Mantel-Haenszel|||Difference in percentage between both arms is reported. H0: Colonoscopy (Standard of Care) percentage \<= CADe Device percentage (i.e. test of superiority)||2.0|-1.5|0.7813
72451015|NCT05275556|144422590|SUPERIORITY||Least-squares means|0.11|||||TWO_SIDED|95.0|0.05|0.17||||||||0.17|0.05|
72451016|NCT05275556|144422591|SUPERIORITY||Mean Difference (Final Values)|8.3||||0.0004|TWO_SIDED|95.0|3.7|12.9||Nominal p-value|Cochran-Mantel-Haenszel|||Difference in percentage between both arms is reported. H0: Colonoscopy (Standard of Care) percentage \<= CADe Device percentage (i.e. test of superiority)||12.9|3.7|0.0004
72451017|NCT05275556|144422592|SUPERIORITY||Mean Difference (Final Values)|4.1||||0.1185|TWO_SIDED|95.0|-1.0|9.1||Nominal p-value|Cochran-Mantel-Haenszel|||Difference in percentage between both arms is reported. H0: Colonoscopy (Standard of Care) percentage \<= CADe Device percentage (i.e. test of superiority)||9.1|-1|0.1185
72451018|NCT05275556|144422593|SUPERIORITY||Mean Difference (Final Values)|4.4||||0.0752|TWO_SIDED|95.0|-0.4|9.2||nominal p-value|Cochran-Mantel-Haenszel|||Difference in percentage between both arms is reported. H0: Colonoscopy (Standard of Care) percentage \<= CADe Device percentage (i.e. test of superiority)||9.2|-0.4|0.0752
72499004|NCT00348140|144528176|SUPERIORITY||Mean Difference (Net)|-0.01||||0.366|TWO_SIDED|95.0|-0.05|0.02|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|Utility score Week 48||0.02|-0.05|0.366
72451019|NCT05275556|144422595|SUPERIORITY||Mean Difference (Final Values)|-0.3||||0.8194|TWO_SIDED|95.0|-3.2|2.6||Nominal p-value|Cochran-Mantel-Haenszel|||Difference in percentage between both arms is reported. H0: Colonoscopy (Standard of Care) percentage \<= CADe Device percentage (i.e. test of superiority)||2.6|-3.2|0.8194
72451020|NCT05275556|144422596|OTHER|Test for difference|Incidence Rate Ratio|1.39||||0.0008|TWO_SIDED|95.0|1.14|1.69||Nominal p-value|Exact poisson|||||1.69|1.14|0.0008
72451021|NCT04564209|144422653|SUPERIORITY|||||||0.455|||||||ANOVA|||||||.455
72451022|NCT04564209|144422654|SUPERIORITY|||||||0.415|||||||ANOVA|||||||.415
72451023|NCT04564209|144422655|SUPERIORITY|||||||0.443|||||||ANOVA|||||||.443
72451024|NCT04564209|144422656|SUPERIORITY|||||||0.457|||||||ANOVA|||||||.457
72451025|NCT04564209|144422657|SUPERIORITY|||||||0.099|||||||ANOVA|||||||.099
72451026|NCT04564209|144422658|SUPERIORITY|||||||0.338|||||||ANOVA|||||||.338
72451027|NCT04564209|144422659|SUPERIORITY|||||||0.723|||||||ANOVA|||||||.723
72451028|NCT04564209|144422661|SUPERIORITY|||||||0.578|||||||t-test, 2 sided|||||||.578
72451029|NCT04564209|144422662|SUPERIORITY|||||||0.998|||||||t-test, 2 sided|||||||.998
72451030|NCT04564209|144422663|SUPERIORITY|||||||0.864|||||||t-test, 2 sided|||||||.864
72451031|NCT04679389|144422664|SUPERIORITY|||||||0.84|||||||t-test, 2 sided|||||||0.84
72451032|NCT04679389|144422665|SUPERIORITY|||||||0.48|||||||Fisher Exact|||||||0.48
72451033|NCT04679389|144422666|SUPERIORITY|||||||0.48|||||||Fisher Exact|||||||0.48
72451034|NCT04679389|144422667|SUPERIORITY||||||>|0.99|||||||Fisher Exact|||||||>0.99
72451035|NCT04679389|144422670|SUPERIORITY|||||||0.31|||||||t-test, 2 sided|||||||0.31
72451036|NCT04679389|144422671|SUPERIORITY|||||||0.09|||||||t-test, 2 sided|||||||0.09
72499005|NCT00348140|144528176|SUPERIORITY||Mean Difference (Net)|0.0||||0.769|TWO_SIDED|95.0|-0.03|0.02|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|Utility score Week 48||0.02|-0.03|0.769
72499006|NCT00348140|144528177|SUPERIORITY||Mean Difference (Net)|-0.2||||0.529|TWO_SIDED|95.0|-0.7|0.3|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|Week 12||0.3|-0.7|0.529
72451037|NCT04099732|144422672|OTHER||Ratio of geometric means (T/R) %|183.36|||||TWO_SIDED|90.0|164.35|204.56|||||Geometric coefficient of variation (gCV) = 16.5.|Relative bioavailability. The statistical model was an ANOVA model on the logarithmic scale, considering the effects 'subjects' as random and 'treatment' as fixed.||204.56|164.35|
72451038|NCT04099732|144422673|OTHER||Ratio of geometric means (T/R) %|174.01|||||TWO_SIDED|90.0|154.73|195.68|||||Geometric coefficient of variation (gCV) = 17.7|Relative bioavailability. The statistical model was an ANOVA model on the logarithmic scale, considering the effects 'subjects' as random and 'treatment' as fixed.||195.68|154.73|
72561949|NCT04284553|144654833|SUPERIORITY||Mean Difference (Final Values)|-12.0|||||TWO_SIDED|95.0|-45.5|21.5|||||"The estimate compares having risk framing as an intervention factor in the arm the patients' primary care providers were assigned to vs. all others not having risk framing in the arm they were assigned to."|Outcomes were evaluated using generalized linear mixed models with an identity link and normally-distributed errors, evaluating the association between the intervention factors (i.e., behavioral components) and secondary outcome, pooling across both stages of the 2-stage Atrius adaptive trial and adjusting for provider-level clustering. As noted in our Study Protocol and pre-specified, the analyses are conducted across intervention factors across study arms, rather than between the study arms.||21.5|-45.5|
72451039|NCT04099732|144422674|OTHER||Ratio of geometric means (T/R) %|119.1|||||TWO_SIDED|90.0|109.84|129.15|||||Geometric coefficient of variation (gCV) = 11.1.|Relative Bioavailability. The statistical model was an ANOVA model on the logarithmic scale, considering the effects 'subjects' as random and 'treatment' as fixed.||129.15|109.84|
72451040|NCT04099732|144422675|OTHER||Ratio of geometric means (T/R) %|119.2|||||TWO_SIDED|90.0|107.68|131.94|||||Geometric coefficient of variation (gCV) = 13.9.|Relative Bioavailability. The statistical model was an ANOVA model on the logarithmic scale, considering the effects 'subjects' as random and 'treatment' as fixed.||131.94|107.68|
72451041|NCT04099732|144422676|OTHER||Ratio of geometric means (T/R) %|186.38|||||TWO_SIDED|90.0|169.7|204.71|||||Geometric coefficient of variation (gCV) = 14.1.|Relative Bioavailability. The statistical model was an ANOVA model on the logarithmic scale, considering the effects 'subjects' as random and 'treatment' as fixed.||204.71|169.70|
72451042|NCT04099732|144422677|OTHER||Ratio of geometric means (T/R) %|120.11|||||TWO_SIDED|90.0|110.78|130.23|||||Geometric coefficient of variation (gCV) = 11.1|Relative Bioavailability. The statistical model was an ANOVA model on the logarithmic scale, considering the effects 'subjects' as random and 'treatment' as fixed.||130.23|110.78|
72451043|NCT05257603|144422678|OTHER||Mean Difference (Net)|4.82|STANDARD_ERROR_OF_MEAN|0.615|<|0.99|TWO_SIDED|95.0|3.24|5.72|||ANOVA|||||5.72|3.24|<0.99
72451044|NCT05257603|144422679|OTHER||||||<|0.29|||||||Chi-squared|||||||<.29
72451045|NCT05257603|144422680|OTHER||||||<|0.99|||||||ANOVA|||A one-way ANOVA was used to compare the mean difference in key presses from time 1 to time 2 between the intervention (RPCW) and Control conditions.||||<0.99
72451046|NCT05257603|144422681|OTHER||||||<|0.45|||||||ANOVA|||||||<0.45
72451047|NCT05257603|144422682|OTHER||||||<|0.1||||||Given the exploratory nature of the analysis we were looking for a trend in improvement in emotion regulation (i.e., p\<.10) following the intervention condition compared to control.|ANOVA|||||||<.10
72451048|NCT05257603|144422683|OTHER||||||<|0.1|||||||ANOVA|||Repeated measure ANOVA was used to provide preliminary information for estimating sample sizes needed for a larger Stage II efficacy trial. The current pilot RCT was not powered to find significant effects.||||<.10
72451049|NCT05257603|144422684|OTHER||||||<|0.1||||||A priori threshold for a trend set at p\<.10 for condition effect (intervention v control).|ANOVA|||An exploratory repeated measures ANOVA with time (4) as the within-subjects variable and condition (2) as the between-subjects variable was conducted to provide preliminary information for estimating sample sizes needed for a larger Stage II efficacy trial. The current pilot RCT was not powered to find significant effects.||||<.10
72451050|NCT05257603|144422685|OTHER||||||<|0.098|||||||ANOVA|||An exploratory repeated measures ANOVA with time (4) as the within-subjects variable and condition (2) as the between-subjects variable was conducted to provide preliminary information for estimating sample sizes needed for a larger Stage II efficacy trial.||||<.098
72451051|NCT03279978|144422703|OTHER||Slope|0.7124|STANDARD_ERROR_OF_MEAN|0.0694|||TWO_SIDED|95.0|0.5702|0.8546||||||Dose proportionality for AUC0-24 of BI 730357 in plasma - fasted groups was assessed using a power model (regression model applied to log-transformed data). In this study AUCtau,1 = AUC0-24|Standard error of the mean is actually standard error of the slope. Based on the estimate for the slope parameter, a two sided 95% confidence interval for the slope was computed. Perfect dose proportionality would correspond to a slope of 1.|0.8546|0.5702|
72451052|NCT03279978|144422703|OTHER||Slope|0.5964|STANDARD_ERROR_OF_MEAN|0.0575|||TWO_SIDED|95.0|0.4777|0.7151||||||Dose proportionality for AUC0-24 of BI 730357 in plasma - fed groups was assessed using a power model (regression model applied to log-transformed data). In this study AUCtau,1 = AUC0-24|Standard error of the mean is actually standard error of the slope. Based on the estimate for the slope parameter, a two sided 95% confidence interval for the slope was computed. Perfect dose proportionality would correspond to a slope of 1.|0.7151|0.4777|
72451053|NCT03279978|144422704|OTHER||Slope|0.6445|STANDARD_ERROR_OF_MEAN|0.0649|||TWO_SIDED|95.0|0.5124|0.7766||||||Dose proportionality for Cmax of BI 730357 in plasma - fasted groups was assessed using a power model (regression model applied to log-transformed data).|Standard error of the mean is actually standard error of the slope. Based on the estimate for the slope parameter, a two sided 95% confidence interval for the slope was computed. Perfect dose proportionality would correspond to a slope of 1.|0.7766|0.5124|
72451054|NCT03279978|144422704|OTHER||Slope|0.6223|STANDARD_ERROR_OF_MEAN|0.0715|||TWO_SIDED|95.0|0.4747|0.7699||||||Dose proportionality for Cmax of BI 730357 in plasma - fed groups was assessed using a power model (regression model applied to log-transformed data).|Standard error of the mean is actually standard error of the slope. Based on the estimate for the slope parameter, a two sided 95% confidence interval for the slope was computed. Perfect dose proportionality would correspond to a slope of 1.|0.7699|0.4747|
72451055|NCT03279978|144422705|OTHER||Slope|0.6401|STANDARD_ERROR_OF_MEAN|0.0909|||TWO_SIDED|95.0|0.4545|0.8258||||||Dose proportionality for AUCτ,ss of BI 730357 in plasma - fasted groups was assessed using a power model (regression model applied to log-transformed data).|Standard error of the mean is actually standard error of the slope. Based on the estimate for the slope parameter, a two sided 95% confidence interval for the slope was computed. Perfect dose proportionality would correspond to a slope of 1.|0.8258|0.4545|
72391297|NCT03000439|144289785|OTHER||Difference in LS Mean|-6.22|||||TWO_SIDED|95.0|-18.95|6.5||||||CHQ01-Social Limitations: Physical Subscale Standardized Score; DB Week 24: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||6.50|-18.95|
72391298|NCT03000439|144289785|OTHER||Difference in LS Mean|11.09|||||TWO_SIDED|95.0|-46.24|68.42||||||CHQ01-Social Limitations: Physical Subscale Standardized Score; DB Week 48: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||68.42|-46.24|
72391299|NCT03000439|144289785|OTHER||Difference in LS Mean|-1.45|||||TWO_SIDED|95.0|-13.97|11.06||||||CHQ01-Bodily Pain Subscale Standardized Score: DB Week 24: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||11.06|-13.97|
72391300|NCT03000439|144289785|OTHER||Difference in LS Mean|17.2|||||TWO_SIDED|95.0|-28.01|62.41||||||CHQ01-Bodily Pain Subscale Standardized Score: DB Week 48: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||62.41|-28.01|
72391301|NCT03000439|144289785|OTHER||Difference in LS Mean|-5.15|||||TWO_SIDED|95.0|-13.24|2.93||||||CHQ01-Behavior Subscale Standardized Score; DB Week 24: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||2.93|-13.24|
72391302|NCT03000439|144289785|OTHER||Difference in LS Mean|-15.03|||||TWO_SIDED|95.0|-33.12|3.06||||||CHQ01-Behavior Subscale Standardized Score; DB Week 48: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||3.06|-33.12|
72391303|NCT03000439|144289785|OTHER||Difference in LS Mean|-5.32|||||TWO_SIDED|95.0|-16.92|6.29||||||CHQ01-Global Behavior Subscale Standardized Score; DB Week 24: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||6.29|-16.92|
72391304|NCT03000439|144289785|OTHER||Difference in LS Mean|-7.24|||||TWO_SIDED|95.0|-20.35|5.87||||||CHQ01-Global Behavior Subscale Standardized Score; DB Week 48: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||5.87|-20.35|
72451056|NCT03279978|144422705|OTHER||Slope|0.5811|STANDARD_ERROR_OF_MEAN|0.0864|||TWO_SIDED|95.0|0.4013|0.7609||||||Dose proportionality for AUCτ,ss of BI 730357 in plasma - fed groups was assessed using a power model (regression model applied to log-transformed data).|Standard error of the mean is actually standard error of the slope. Based on the estimate for the slope parameter, a two sided 95% confidence interval for the slope was computed. Perfect dose proportionality would correspond to a slope of 1.|0.7609|0.4013|
72451057|NCT03279978|144422706|OTHER||Slope|0.6005|STANDARD_ERROR_OF_MEAN|0.0722|||TWO_SIDED|95.0|0.4534|0.7477||||||Dose proportionality for Cmax,ss of BI 730357 in plasma - fasted groups was assessed using a power model (regression model applied to log-transformed data).|Standard error of the mean is actually standard error of the slope. Based on the estimate for the slope parameter, a two sided 95% confidence interval for the slope was computed. Perfect dose proportionality would correspond to a slope of 1.|0.7477|0.4534|
72451058|NCT03279978|144422706|OTHER||Slope|0.5799|STANDARD_ERROR_OF_MEAN|0.0656|||TWO_SIDED|95.0|0.4441|0.7156||||||Dose proportionality for Cmax,ss of BI 730357 in plasma - fed groups was assessed using a power model (regression model applied to log-transformed data).|Standard error of the mean is actually standard error of the slope. Based on the estimate for the slope parameter, a two sided 95% confidence interval for the slope was computed. Perfect dose proportionality would correspond to a slope of 1.|0.7156|0.4441|
72391305|NCT03000439|144289785|OTHER||Difference in LS Mean|4.44|||||TWO_SIDED|95.0|-6.18|15.07||||||CHQ01-Mental Health Subscale Standardized Score; DB Week 24: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||15.07|-6.18|
72391306|NCT03000439|144289785|OTHER||Difference in LS Mean|-7.46|||||TWO_SIDED|95.0|-24.37|9.45||||||CHQ01-Mental Health Subscale Standardized Score; DB Week 48: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||9.45|-24.37|
72451059|NCT00626795|144422716|NON_INFERIORITY|The lower confidence limit greater or equal to -12.5% indicates non-inferiority.|Difference in percentage|4.56|||||TWO_SIDED|95.0|-1.59|10.71|||||Estimated using a Cochran-Mantel-Haenszel approach, stratifying by country and disease (impetigo/SITL).|||10.71|-1.59|
72451060|NCT00626795|144422716|NON_INFERIORITY|The lower confidence limit greater or equal to -12.5% indicates non-inferiority.|Difference in percentage|-3.35|||||TWO_SIDED|95.0|-10.28|3.57|||||Estimated using a Cochran-Mantel-Haenszel approach, stratifying by country and disease (impetigo/SITL).|||3.57|-10.28|
72451061|NCT04159519|144422723|OTHER|Mixed model for repeated measure (MMRM) with fixed effects for treatment arm, visit, baseline value, and treatment-by-visit interaction with an unstructured covariance structure.|Least square mean difference|0.1062|||||TWO_SIDED|95.0|-0.0485|0.2609||||||Comparison with reference arm||0.2609|-0.0485|
72451062|NCT04159519|144422724|OTHER|Comparison|Least square mean difference|-0.0343|||||TWO_SIDED|95.0|-0.2527|0.1841|||Mixed model for repeated measure (MMRM)|MMRM with fixed effects for treatment arm, visit, baseline value, and treatment-by-visit interaction with an unstructured covariance structure.||Comparison with reference arm||0.1841|-0.2527|
72451063|NCT03636490|144422750|OTHER|We tested an association between change in urinary sodium excretion rate with stress and ratio of awake-to-asleep urinary sodium excretion rate.|unstandardized B coefficients|0.0021||||0.0032||95.0|0.0007|0.0034|||Regression, Linear|Adjusted for age, sex, race, ethnicity, body mass index, mean DBP during the baseline period, and 24-hour creatinine clearance.||||0.0034|0.0007|0.0032
72451064|NCT03636490|144422751|OTHER|We tested an association between ratio of awake-to-asleep urinary sodium excretion rate and SBP dipping.|unstandardized B coefficients|0.8244||||0.037||95.0|0.0487|1.6|||Regression, Linear|Adjusted for age, sex, race, ethnicity, BMI, smoking, alcohol use, glucose, 24-hr sodium and potassium excretion, 24-hr creat clear, and FENa|Data are unstandardized B coefficients (95% CI)|||1.6000|0.0487|0.037
72499007|NCT00348140|144528177|SUPERIORITY||Mean Difference (Net)|-0.1||||0.62|TWO_SIDED|95.0|-0.7|0.4|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|Week 12||0.4|-0.7|0.620
72451065|NCT02246127|144422765|SUPERIORITY||Odds Ratio (OR)|0.65||||0.229|TWO_SIDED|95.0|0.32|1.32|||Regression, Cox|||significant differences between both arms is assumed in case p-val \< 0.05||1.32|0.32|0.229
72451066|NCT02246127|144422766|SUPERIORITY||Hazard Ratio (HR)|1.4||||0.135|TWO_SIDED|95.0|0.9|2.19|||Regression, Cox|||significant differences between both arms is assumed in case p-val \< 0.05||2.19|0.90|0.135
72451067|NCT02246127|144422767|SUPERIORITY||Hazard Ratio (HR)|1.16||||0.474|TWO_SIDED|95.0|0.77|1.75|||Regression, Cox|||significant differences between both arms is assumed in case p-val \< 0.05||1.75|0.77|0.474
72499008|NCT00348140|144528177|SUPERIORITY||Mean Difference (Net)|-0.4||||0.284|TWO_SIDED|95.0|-1.0|0.3|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|Week 36||0.3|-1.0|0.284
72561950|NCT03239496|144654836|NON_INFERIORITY|All non-inferiority comparisons of seroconversion rates will be made utilizing the lower bound of two-sided score-based confidence intervals (α = 0.05) with non-inferiority margin 10%.||||||0.05|||||||t-test, 1 sided|||The group sizes are chosen to provide ≥ 80% power for each of the primary objectives, for the individual statistical tests of each serotype, as well as across both serotypes simultaneously. Power of ≥80% is also available for all secondary objectives, except for the comparison of the f-IPV regimen administered at weeks 14 and 36 to the 3-dose IPV regimen, which has power of 62% for individual serotypes, and 39% for the combined serotypes.||||0.05
72619778|NCT02191397|144770627|OTHER||Mean Difference (Final Values)|0.2||||0.299|TWO_SIDED|95.0|-0.14|0.46||Analysis included Baseline HAMD-17 Sleep Disorder subscale score as covariate, treatment, gender, visit and treatment-visit interaction as fixed effects. Unstructured covariance matrix was used.|Mixed model repeated measures analysis||Comparison for Week 8. OC dataset was used, where available data at a given time point was used with no missing values filled in with estimates.|||0.46|-0.14|0.299
72451068|NCT02246127|144422769|SUPERIORITY|||||||0.001|||||||Fisher Exact|||significant differences between both arms is assumed in case p-val \< 0.05||||0.001
72451069|NCT02246127|144422771|SUPERIORITY|||||||0.012|||||||Fisher Exact|||significant differences between both arms is assumed in case p-val \< 0.05||||0.012
72451070|NCT02246127|144422772|SUPERIORITY|||||||0.001|||||||Fisher Exact|||significant differences between both arms is assumed in case p-val \< 0.05||||0.001
72451071|NCT02246127|144422773|SUPERIORITY||Hazard Ratio (HR)|1.43||||0.168|TWO_SIDED|95.0|0.86|2.37|||Regression, Cox|||significant differences between both arms is assumed in case p-val \< 0.05||2.37|0.86|0.168
72499009|NCT00348140|144528177|SUPERIORITY||Mean Difference (Net)|0.2||||0.488|TWO_SIDED|95.0|-0.4|0.9|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|Week 36||0.9|-0.4|0.488
72370368|NCT02504216|144251357|OTHER||Hazard Ratio (HR)|1.43|||=|0.0695|TWO_SIDED|95.0|0.97|2.1|||Log Rank|P-value (2-sided) is based on the log rank test stratified by type of procedure and clopidogrel use per IxRS assignment with treatment as a factor.||||2.10|0.97|=0.0695
72451072|NCT02246127|144422775|SUPERIORITY|||||||0.072|||||||Fisher Exact|||significant differences between both arms is assumed in case p-val \< 0.05||||0.072
72451073|NCT02246127|144422777|SUPERIORITY||Hazard Ratio (HR)|1.6||||0.079|TWO_SIDED|95.0|0.94|2.73|||Log Rank|||significant differences between both arms is assumed in case p-val \< 0.05||2.73|0.94|0.079
72451074|NCT01223352|144422830|SUPERIORITY_OR_OTHER_LEGACY||Ratio of geometric means|0.85|||||TWO_SIDED|95.0|0.61|1.2||No statistical test of hypothesis was set for this study. The analysis of PK data was carried out descriptively|||b.i.d. bosentan regimen was taken as reference|||1.20|0.61|
72451075|NCT01223352|144422831|SUPERIORITY_OR_OTHER_LEGACY||Ratio of geometric means|0.71|||||TWO_SIDED|95.0|0.48|1.05||No statistical hypothesis tests were set for this study. The analysis of PK data was carried out descriptively.|||b.i.d. bosentan regimen was taken as reference|||1.05|0.48|
72451076|NCT04623775|144422838|SUPERIORITY||Risk Difference (RD)|-6.5|||||TWO_SIDED|95.0|-16.0|3.0||||||||3.0|-16.0|
72451077|NCT04623775|144422839|SUPERIORITY||Odds Ratio (OR)|1.39|||||TWO_SIDED|90.0|0.94|2.05|||Cochran-Mantel-Haenszel|||||2.05|0.94|
72451078|NCT03498521|144422857|SUPERIORITY||Stratified Cox proportional hazard|0.72||||0.0079|TWO_SIDED|95.0|0.56|0.92|||Stratified log-rank|||||0.92|0.56|0.0079
72451079|NCT04214834|144422903|SUPERIORITY||Mean Difference (Final Values)|2.96|||<|0.001|TWO_SIDED|95.0|1.7|4.29|||Mixed Models Analysis||Given that the model was on the log scale, mean difference and 95% confidence interval were derived from 1,000 bootstrap resamples.|A logarithmic transformation was applied to the outcome, centers were added as random effects to account for variation between them.||4.29|1.70|<0.001
72451080|NCT03370913|144422918|SUPERIORITY||% Reduction from Baseline|-77.0|||<|0.0001|TWO_SIDED|||||P-values were for 2-sided test against 0.|t-test, 2 sided|Superiority was tested by1-sample t-test to test null hypothesis that change is \>=0. Only negative changes represent efficacy.|77% reduction|Change from baseline in the ABR for all bleeds (post-baseline EEP value - baseline value)||||<0.0001
72451081|NCT05061017|144422931|SUPERIORITY|||||||1|TWO_SIDED|95.0|||||Fisher Exact|||||||1.0000
72451082|NCT05061017|144422932|SUPERIORITY|||||||1|TWO_SIDED|95.0|||||Fisher Exact|||||||1.0000
72499010|NCT00348140|144528177|SUPERIORITY||Mean Difference (Net)|0.2||||0.549|TWO_SIDED|95.0|-0.5|1.0|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|Week 48||1.0|-0.5|0.549
72561951|NCT03239496|144654837|NON_INFERIORITY|All non-inferiority comparisons of seroconversion rates will be made utilizing the lower bound of two-sided score-based confidence intervals (α = 0.05) with non-inferiority margin 10%.||||||0.05|||||||t-test, 2 sided|||The group sizes are chosen to provide ≥ 80% power for each of the primary objectives, for the individual statistical tests of each serotype, as well as across both serotypes simultaneously. Power of ≥80% is also available for all secondary objectives, except for the comparison of the f-IPV regimen administered at weeks 14 and 36 to the 3-dose IPV regimen, which has power of 62% for individual serotypes, and 39% for the combined serotypes.||||0.05
72561952|NCT03239496|144654838|NON_INFERIORITY|All non-inferiority comparisons of seroconversion rates will be made utilizing the lower bound of two-sided score-based confidence intervals (α = 0.05) with non-inferiority margin 10%.||||||0.05|||||||t-test, 2 sided|||The group sizes are chosen to provide ≥ 80% power for each of the primary objectives, for the individual statistical tests of each serotype, as well as across both serotypes simultaneously. Power of ≥80% is also available for all secondary objectives, except for the comparison of the f-IPV regimen administered at weeks 14 and 36 to the 3-dose IPV regimen, which has power of 62% for individual serotypes, and 39% for the combined serotypes.||||0.05
72561953|NCT03239496|144654839|SUPERIORITY|||||||0.0001|||||||Fisher Exact|||The group sizes are chosen to provide ≥ 80% power for each of the primary objectives, for the individual statistical tests of each serotype, as well as across both serotypes simultaneously. Power of ≥80% is also available for all secondary objectives, except for the comparison of the f-IPV regimen administered at weeks 14 and 36 to the 3-dose IPV regimen, which has power of 62% for individual serotypes, and 39% for the combined serotypes.||||0.0001
72561954|NCT03239496|144654840|SUPERIORITY|||||||0.0001|||||||Fisher Exact|||The group sizes are chosen to provide ≥ 80% power for each of the primary objectives, for the individual statistical tests of each serotype, as well as across both serotypes simultaneously. Power of ≥80% is also available for all secondary objectives, except for the comparison of the f-IPV regimen administered at weeks 14 and 36 to the 3-dose IPV regimen, which has power of 62% for individual serotypes, and 39% for the combined serotypes.||||0.0001
72561955|NCT03239496|144654841|NON_INFERIORITY|All non-inferiority comparisons of seroconversion rates will be made utilizing the lower bound of two-sided score-based confidence intervals (α = 0.05) with non-inferiority margin 10%.||||||0.05|||||||t-test, 2 sided|||The group sizes are chosen to provide ≥ 80% power for each of the primary objectives, for the individual statistical tests of each serotype, as well as across both serotypes simultaneously. Power of ≥80% is also available for all secondary objectives, except for the comparison of the f-IPV regimen administered at weeks 14 and 36 to the 3-dose IPV regimen, which has power of 62% for individual serotypes, and 39% for the combined serotypes.||||0.05
72561956|NCT03239496|144654842|NON_INFERIORITY|All non-inferiority comparisons of seroconversion rates will be made utilizing the lower bound of two-sided score-based confidence intervals (α = 0.05) with non-inferiority margin 10%.||||||0.05|||||||t-test, 2 sided|||The group sizes are chosen to provide ≥ 80% power for each of the primary objectives, for the individual statistical tests of each serotype, as well as across both serotypes simultaneously. Power of ≥80% is also available for all secondary objectives, except for the comparison of the f-IPV regimen administered at weeks 14 and 36 to the 3-dose IPV regimen, which has power of 62% for individual serotypes, and 39% for the combined serotypes.||||0.05
72561957|NCT03239496|144654843|NON_INFERIORITY|All non-inferiority comparisons of seroconversion rates will be made utilizing the lower bound of two-sided score-based confidence intervals (α = 0.05) with non-inferiority margin 10%.||||||0.05|||||||t-test, 2 sided|||The group sizes are chosen to provide ≥ 80% power for each of the primary objectives, for the individual statistical tests of each serotype, as well as across both serotypes simultaneously. Power of ≥80% is also available for all secondary objectives, except for the comparison of the f-IPV regimen administered at weeks 14 and 36 to the 3-dose IPV regimen, which has power of 62% for individual serotypes, and 39% for the combined serotypes.||||0.05
72561958|NCT02339415|144654850|SUPERIORITY||Mean Difference (Net)|0.08|STANDARD_ERROR_OF_MEAN|0.07||0.26|TWO_SIDED|95.0|-0.06|0.21|||Mixed Models Analysis|included predictors: treatment, assigned treatment sequence and pre-treatment biomarker level.|because biomarkers were analyzed on natural log scale, the estimated parameter is the log-transformed mean percent difference in treatment effect on Edoxaban vs. Placebo.|||0.21|-0.06|0.26
72561959|NCT02339415|144654851|SUPERIORITY||Mean Difference (Net)|-0.54|STANDARD_ERROR_OF_MEAN|0.17||0.002|TWO_SIDED|95.0|-0.88|-0.2|||Mixed Models Analysis|included predictors: treatment, assigned treatment sequence and pre-treatment biomarker level.|because biomarkers were analyzed on natural log scale, the estimated parameter is the log-transformed mean percent difference in treatment effect on Edoxaban vs. Placebo.|||-0.20|-0.88|0.002
72561960|NCT00003404|144654853|OTHER||rate of occurance|0.35|||||TWO_SIDED|95.0|0.0|8.0|||||The local recurrence rate was estimated by dividing the number of recurrences by the total sample size. An exact 95% confidence interval (95% CI) for this rate was determined by binomial distribution.|||8|0|
72619779|NCT02191397|144770628|OTHER||Mean Difference (Final Values)|0.0||||0.804|TWO_SIDED|95.0|-0.1|0.13||Analysis included Baseline CGI-S score as covariate, treatment, gender, visit and treatment-visit interaction as fixed effects. Unstructured covariance matrix was used.|Mixed model repeated measures analysis||Comparison for Week 1. OC dataset was used, where available data at a given time point was used with no missing values filled in with estimates.|||0.13|-0.10|0.804
72561961|NCT00676650|144654855|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.914||||0.1678|TWO_SIDED|95.0|0.762|1.097||1-sided p-value from the stratified log-rank test|Log Rank||Based on the Cox Proportional hazards model stratified by Eastern Cooperative Oncology Group (ECOG) and Disease Progression Base.|||1.097|0.762|0.1678
72619780|NCT02191397|144770628|OTHER||Mean Difference (Final Values)|0.1||||0.079|TWO_SIDED|95.0|-0.02|0.28||Analysis included Baseline CGI-S score as covariate, treatment, gender, visit and treatment-visit interaction as fixed effects. Unstructured covariance matrix was used.|Mixed model repeated measures analysis||Comparison for Week 2. OC dataset was used, where available data at a given time point was used with no missing values filled in with estimates.|||0.28|-0.02|0.079
72451083|NCT04602611|144422952|SUPERIORITY||Coefficient of negative binomial model|0.0547||||0.8|TWO_SIDED|95.0|-0.368|0.4773||The a priori threshold for statistical significance was 0.025.|Regression, Negative binomial|Model was estimated without adjustments (sole covariate was treatment; coefficient was the estimated treatment effect) using 180 degrees of freedom.|The estimated coefficient was associated with Oncology Nurse Navigation with reference to Standard of Care.|The study was designed with co-primary objectives evaluating acute care utilization (ACU) and 6-month OS rate. Power/sample size were calculated based on the OS objective. The overall type I error rate was alpha=0.05; the co-primary objectives were powered at the 2-sided alpha=0.025 significance level. Three hundred evaluable subjects would have provided \>=93% power to detect a 20% reduction in ACU (assuming there were 6 ACUs per year in SOC arm). The study did not achieve targeted enrollment.||0.4773|-0.3680|0.80
72451084|NCT04602611|144422953|SUPERIORITY|||||||0.88||||||The a priori threshold for statistical significance was 0.025.|Fisher Exact|No adjustments were made in this analysis.||The study was designed with co-primary objectives evaluating acute care utilization (ACU) and 6-month OS rate. Power/sample size were calculated based on the OS objective. The overall type I error rate was alpha=0.05; the co-primary objectives were powered at the 2-sided alpha=0.025 significance level. Three hundred evaluable subjects would have provided \>=93% power to detect a 20% reduction in ACU (assuming there were 6 ACUs per year in SOC arm). The study did not achieve targeted enrollment.|The proportions of evaluable subjects surviving at 6 months were analyzed in a 2x2 contingency table using Fisher's Exact test. In the SOC arm, 52/87(60%) evaluable subjects were alive at 6 months and 35/87 (40%) were not. In the ONN + SOC arm, 58/95 (61%) evaluable subjects were alive at 6 months and 37/95 (39%) were not. The p-value estimated using Fisher's Exact test on this 2x2 contingency table was p=0.88.|||0.88
72451085|NCT04602611|144422954|SUPERIORITY|||||||0.74||||||This p-value was not adjusted for multiple comparisons; the a priori threshold for statistical significance was p=0.05.|Fisher Exact|No adjustments were made in this analysis.|||The proportions of evaluable subjects surviving at 12 months were analyzed in a 2x2 contingency table using Fisher's Exact test. In the SOC arm, 23/87(26%) evaluable subjects were alive at 12 months and 64/87(74%) were not. In the ONN + SOC arm, 28/95 (29%) evaluable subjects were alive at 6 months and 67/95 (71%) were not. The p-value estimated using Fisher's Exact test on this 2x2 contingency table was p=0.74.|||0.74
72451086|NCT04602611|144422955|SUPERIORITY||Coefficient of negative binomial model|0.1574||||0.57|TWO_SIDED|95.0|-0.3905|0.7054||This p-value was not adjusted for multiple comparisons; the a priori threshold for statistical significance was p=0.05.|Regression, Negative binomial|Model was estimated without adjustments (sole covariate was treatment; coefficient was the estimated treatment effect) using 180 degrees of freedom.|The estimated coefficient was associated with Oncology Nurse Navigation with reference to Standard of Care.|||0.7054|-0.3905|0.57
72451087|NCT04602611|144422956|SUPERIORITY||Hazard Ratio (HR)|0.864||||0.45|TWO_SIDED|95.0|0.57|1.309||This p-value was not adjusted for multiple comparisons; the a priori threshold for statistical significance was p=0.05.|Log Rank|Unadjusted log-rank test|The estimated hazard ratio was associated with Oncology Nurse Navigation with reference to Standard of Care; the model was estimated without adjustments (the sole covariate was treatment).|||1.309|0.570|0.45
72451088|NCT04602611|144422957|SUPERIORITY||Coefficient of negative binomial model|-0.4194||||0.21|TWO_SIDED|95.0|-1.0763|0.2374||This p-value was not adjusted for multiple comparisons; the a priori threshold for statistical significance was p=0.05.|Regression, Negative binomial|Model was estimated without adjustments (sole covariate was treatment; coefficient was the estimated treatment effect) using 180 degrees of freedom.|The estimated coefficient was associated with Oncology Nurse Navigation with reference to Standard of Care.|||0.2374|-1.0763|0.21
72451089|NCT04602611|144422958|SUPERIORITY||Odds Ratio (OR)|3.28|||<|0.01|TWO_SIDED|95.0|1.75|6.15||This p-value was not adjusted for multiple comparisons; the a priori threshold for statistical significance was p=0.05.|Regression, Logistic|Model was estimated without adjustments (the sole covariate was treatment).|The estimated odds ratio was associated with Oncology Nurse Navigation with reference to Standard of Care.|||6.15|1.75|<0.01
72451090|NCT04602611|144422959|SUPERIORITY||Slope|-2.6939||||0.11|TWO_SIDED|95.0|-5.9538|0.5659||This p-value was not adjusted for multiple comparisons; the a priori threshold for statistical significance was p=0.05.|Regression, Linear|Model was estimated without adjustments (sole covariate was treatment; slope was the estimated treatment effect) using 180 degrees of freedom.|The estimated slope was associated with Oncology Nurse Navigation with reference to Standard of Care.|||0.5659|-5.9538|0.11
72451091|NCT04602611|144422960|SUPERIORITY||Slope|0.1197||||0.09|TWO_SIDED|95.0|-0.0315|0.4378||This p-value was not adjusted for multiple comparisons; the a priori threshold for statistical significance was p=0.05.|Regression, Linear|This univariate model was not adjusted for other covariates; this model was estimated using 84 degrees of freedom.|The estimated slope was associated with Oncology Nurse Navigation with reference to Standard of Care.|||0.4378|-0.0315|0.09
72499011|NCT00348140|144528177|SUPERIORITY||Mean Difference (Net)|0.1||||0.78|TWO_SIDED|95.0|-0.6|0.9|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|For Week 48||0.9|-0.6|0.780
72451092|NCT04631016|144422961|OTHER||LS Mean Difference|0.024||||0.216|TWO_SIDED|80.0|-0.015|0.063|||Mixed Models Analysis|||||0.063|-0.015|0.216
72451093|NCT04631016|144422964|SUPERIORITY||Hazard Ratio (HR)|0.79||||0.186|TWO_SIDED|80.0|0.57|1.11|||Regression, Cox|||||1.11|0.57|0.186
72451094|NCT04631016|144422985|SUPERIORITY||Least square mean difference|0.067||||0.044|TWO_SIDED|80.0|0.017|0.116||One-sided p-value|Mixed Models Analysis|Kenward-Roger correction has been used for degrees of freedom approximation in the generation of model.||Results are based on the mixed model for repeated measures (MMRM) analysis at Week 12.||0.116|0.017|0.044
72451095|NCT04631016|144422985|SUPERIORITY||Least square mean difference|0.07||||0.036|TWO_SIDED|80.0|0.02|0.12||One-sided p-value|Mixed Models Analysis|Kenward-Roger correction has been used for degrees of freedom approximation in the generation of model.||Results are based on the MMRM analysis at Week 28.||0.120|0.020|0.036
72499012|NCT00348140|144528178|SUPERIORITY||Mean Difference (Net)|-0.6||||0.106|TWO_SIDED|95.0|-1.3|0.1|||ANCOVA|||||0.1|-1.3|0.106
72451096|NCT04496752|144422986|EQUIVALENCE|Weighted Cohen's kappa statistics were computed between DCTClock-pen and MMSE, and between DCTClock-tablet and MMSE. A TOST (two one-sided test) of equivalence was planned, with a difference in kappa of 0.2 specified a priori as significant.|Difference in Cohen's Kappa|0.07|||||TWO_SIDED|90.0|-0.05|0.19|||||The difference is Cohen's kappa is (tablet - pen). The confidence interval is estimated with a nonparametric bootstrap (5000 samples).|||0.19|-0.05|
72451097|NCT04967599|144423002|SUPERIORITY|||||||0.81|||||||Kruskal-Wallis|||||||.81
72451098|NCT04967599|144423003|SUPERIORITY|||||||0.46|||||||Kruskal-Wallis|||||||.46
72451099|NCT04967599|144423004|SUPERIORITY|||||||0.49|||||||Kruskal-Wallis|||||||.49
72451100|NCT04967599|144423005|SUPERIORITY|||||||0.59|||||||Kruskal-Wallis|||||||.59
72451101|NCT04967599|144423006|SUPERIORITY|||||||0.29|||||||Fisher Exact|||||||.29
72619781|NCT02191397|144770628|OTHER||Mean Difference (Final Values)|0.2||||0.036|TWO_SIDED|95.0|0.01|0.38||Analysis included Baseline CGI-S score as covariate, treatment, gender, visit and treatment-visit interaction as fixed effects. Unstructured covariance matrix was used.|Mixed model repeated measures analysis||Comparison for Week 4. OC dataset was used, where available data at a given time point was used with no missing values filled in with estimates.|||0.38|0.01|0.036
72370369|NCT02504216|144251358|SUPERIORITY||Hazard Ratio (HR)|0.8|||=|0.0004|TWO_SIDED|95.0|0.71|0.91||P-value (1-sided) is based on the log rank test stratified by type of procedure and clopidogrel use per IxRS assignment with treatment as a factor.|Log Rank|||||0.91|0.71|=0.0004
72451102|NCT04967599|144423007|SUPERIORITY|||||||0.49|||||||Fisher Exact|||||||.49
72451103|NCT05123027|144423024|SUPERIORITY||Risk Ratio (RR)|0.7||||0.399|TWO_SIDED|95.0|0.3|1.62||Threshold for significance: p\< 0.05|Mixed Models Analysis|||The primary outcome was analyzed with a longitudinal mixed effects negative binomial model incorporating the total score at earlier time points as well as 180 days. Fixed effect covariates included baseline score, treatment, days, site, stratum, and an interaction between treatment and days. A random effect was included to account for correlation within each participant.||1.62|0.30|0.399
72451104|NCT05123027|144423025|SUPERIORITY||Risk Ratio (RR)|1.09||||0.53|TWO_SIDED|95.0|0.83|1.45||Threshold for significance: p\< 0.05|Mixed Models Analysis|||This was modeled similar to the primary outcome, an over dispersed Poisson regression model with fixed effect covariates for treatment arm, treatment days, site, and stratum with an interaction between treatment arm and treatment days. Note that no baseline score covariate was included as all participants will be considered to have achieved 0 steps at baseline. A random intercept was included for each subject to account for repeated measures.||1.45|0.83|0.53
72451105|NCT04024059|144423032|SUPERIORITY||Odds Ratio (OR)|1.737|||=|0.22|TWO_SIDED|95.0|0.719|4.195|||Regression, Logistic|||||4.195|0.719|=0.22
72451106|NCT04024059|144423032|SUPERIORITY||Odds Ratio (OR)|1.035|||=|0.938|TWO_SIDED|95.0|0.435|2.461|||Regression, Logistic|||||2.461|0.435|=0.938
72451107|NCT04024059|144423033|SUPERIORITY||Odds Ratio (OR)|1.783|||=|0.202|TWO_SIDED|95.0|0.733|4.336|||Regression, Logistic|||||4.336|0.733|=0.202
72451108|NCT04024059|144423033|SUPERIORITY||Odds Ratio (OR)|1.38|||=|0.474|TWO_SIDED|95.0|0.571|3.336|||Regression, Logistic|||||3.336|0.571|=.474
72451109|NCT04024059|144423034|SUPERIORITY||Odds Ratio (OR)|0.669|||=|0.328|TWO_SIDED|95.0|0.299|1.497|||Regression, Logistic|||||1.497|0.299|=0.328
72451110|NCT04024059|144423034|SUPERIORITY||Odds Ratio (OR)|0.724|||=|0.435|TWO_SIDED|95.0|0.322|1.627|||Regression, Logistic|||||1.627|0.322|=0.435
72451111|NCT05541484|144423041|OTHER|Spearman's ρ given non-normal variable distributions|||||<|0.0001||||||Spearman's ρ given non-normal variable distributions|Wilcoxon (Mann-Whitney)|||||||< 0.0001
72451112|NCT02911805|144423047|OTHER||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
72451113|NCT02624050|144423056|SUPERIORITY||Risk Ratio (RR)|1.0||||0.01|TWO_SIDED|||||Threshold for significance was p\<0.05.|log-binomial regression|||||||0.01
72451114|NCT02624050|144423057|SUPERIORITY||Risk Ratio (RR)|1.0||||0.37|TWO_SIDED|||||Threshold of significance was \<0.05|log binomial regression|||||||0.37
72451115|NCT02624050|144423062|SUPERIORITY|||||||0.277||||||"Because the data were skewed, the natural logarithmic transformation was used prior to analysis for inference.~Threshold for statistical significance was \<0.05"|Ratio of Geometric Means|This p-value is for 15 min after induction of anesthesia||||||0.277
72451116|NCT03904576|144423067|OTHER||Difference of least squares means (T-R)|-7.305|STANDARD_ERROR_OF_MEAN|2.082|||TWO_SIDED|90.0|-10.949|-3.661||||||Mixed effects model including effects for 'treatment', 'period' and 'subject' as well as covariates 'period baseline' and 'subject baseline'.||-3.661|-10.949|
72451117|NCT03904576|144423067|OTHER||Difference in %|-24.396|||||||||||||Difference of least squares means in % (ratio to Placebo) (T-R)/R\*100%|Mixed effects model including effects for 'treatment', 'period' and 'subject' as well as covariates 'period baseline' and 'subject baseline'.||||
72451118|NCT05215054|144423068|NON_INFERIORITY|Non-inferiority will be demonstrated if the upper limit of the two-sided 95%CI of the difference of changes from baseline between test device and control is inferior or equal to 0.5.||||||||||||||||Difference of changes from baseline in WSRS score for Gana V versus Sculptra|Non-inferiority will be demonstrated if the upper limit of the two-sided 95%CI of the difference of changes from baseline between test device and control is inferior or equal to 0.5.To assess assay sensitivity, the proportion of responders with Gana V®, defined as improvement of ≥1-grade in the WSRS when compared to D0 pre-injection must be ≥50% at the 6 months visit after baseline.|||
72451119|NCT03364127|144423089|SUPERIORITY||Mean Difference (Net)|-0.12||||0.702|TWO_SIDED|95.0|-0.76|0.51|||ANCOVA|Full information maximum likelihood for missing data and to retain participants for intention to treat model. Adjusted for baseline value.||||.51|-.76|0.702
72499013|NCT00348140|144528178|SUPERIORITY||Mean Difference (Net)|-0.4||||0.229|TWO_SIDED|95.0|-1.2|0.3|||ANCOVA|||||0.3|-1.2|0.229
72619782|NCT02191397|144770628|OTHER||Mean Difference (Final Values)|0.1||||0.248|TWO_SIDED|95.0|-0.08|0.31||Analysis included Baseline CGI-S score as covariate, treatment, gender, visit and treatment-visit interaction as fixed effects. Unstructured covariance matrix was used.|Mixed model repeated measures analysis||Comparison for Week 6. OC dataset was used, where available data at a given time point was used with no missing values filled in with estimates.|||0.31|-0.08|0.248
72619783|NCT02191397|144770628|OTHER||Mean Difference (Final Values)|0.2||||0.11|TWO_SIDED|95.0|-0.04|0.35||Analysis included Baseline CGI-S score as covariate, treatment, gender, visit and treatment-visit interaction as fixed effects. Unstructured covariance matrix was used.|Mixed model repeated measures analysis||Comparison for Week 8. OC dataset was used, where available data at a given time point was used with no missing values filled in with estimates.|||0.35|-0.04|0.110
72619784|NCT02191397|144770629|OTHER||Odds Ratio, log|0.78||||0.545|TWO_SIDED|95.0|0.35|1.75||P-value was estimated from a GEE model repeated measures with CGI-I score of 1 or 2 as response variable and treatment, gender as explanatory variables|GEE model repeated measures||Comparison for Week 1. OC dataset was used, where available data at a given time point was used with no missing values filled in with estimates.|||1.75|0.35|0.545
72619785|NCT02191397|144770629|OTHER||Odds Ratio (OR)|0.95||||0.822|TWO_SIDED|95.0|0.58|1.54||P-value was estimated from a GEE model repeated measures with CGI-I score of 1 or 2 as response variable and treatment, gender as explanatory variables|GEE model repeated measures||Comparison for Week 2. OC dataset was used, where available data at a given time point was used with no missing values filled in with estimates.|||1.54|0.58|0.822
72451120|NCT03364127|144423090|SUPERIORITY||Mean Difference (Net)|0.1||||0.77|TWO_SIDED|95.0|-0.58|0.79|||ANCOVA|Full information maximum likelihood for missing data and to retain participants for intention to treat model. Adjusted for baseline value.||||.79|-.58|0.77
72561962|NCT00676650|144654856|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.725|||<|0.001|TWO_SIDED|95.0|0.591|0.89||1-sided p-value from the stratified log-rank test.|Log Rank||Based on Cox Proportional Hazards Model stratified by ECOG and Disease Progression Base.|||0.890|0.591|<0.001
72561963|NCT00676650|144654857|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.561||||0.04|TWO_SIDED|95.0|1.0|19.0||p-value from 2-sided Fisher's Exact test.|Fisher Exact|||||19.0|1.0|0.040
72619786|NCT02191397|144770629|OTHER||Odds Ratio (OR)|0.57||||0.007|TWO_SIDED|95.0|0.38|0.86||P-value was estimated from a GEE model repeated measures with CGI-I score of 1 or 2 as response variable and treatment, gender as explanatory variables|GEE model repeated measures||Comparison for Week 4. OC dataset was used, where available data at a given time point was used with no missing values filled in with estimates.|||0.86|0.38|0.007
72619787|NCT02191397|144770629|OTHER||Odds Ratio (OR)|0.83||||0.417|TWO_SIDED|95.0|0.54|1.29||P-value was estimated from a GEE model repeated measures with CGI-I score of 1 or 2 as response variable and treatment, gender as explanatory variables|GEE model repeated measures||Comparison for Week 6. OC dataset was used, where available data at a given time point was used with no missing values filled in with estimates.|||1.29|0.54|0.417
72619788|NCT02191397|144770629|OTHER||Odds Ratio (OR)|0.83||||0.485|TWO_SIDED|95.0|0.49|1.4||P-value was estimated from a GEE model repeated measures with CGI-I score of 1 or 2 as response variable and treatment, gender as explanatory variables|GEE model repeated measures||Comparison for Week 8. OC dataset was used, where available data at a given time point was used with no missing values filled in with estimates.|||1.40|0.49|0.485
72619789|NCT03888482|144770710|NON_INFERIORITY|Non-inferiority margin = 0.05|Least Squares Mean Difference|0.0|||||ONE_SIDED|95.0||0.01|||Mixed effects repeated measures model|Mixed effects repeated measures model with terms for lens, period and sequence as fixed effects and subject as a random effect.|Difference = DDT2 - Clariti|||0.01||
72619790|NCT03721107|144770711|SUPERIORITY||Difference in Percentage|7.9||||0.152|TWO_SIDED|95.0|-6.0|21.9||P-value is from a 1-sided Pearson chi-square test with Yates' correction with null hypothesis that the difference in proportions Blautix - placebo \<=0 versus the difference is \>0. The significance level for rejection of the null hypotheses is 0.10.|Chi-squared, Corrected|||||21.9|-6.0|0.152
72619791|NCT03721107|144770711|SUPERIORITY||Difference in Percentage|5.6||||0.216|TWO_SIDED|95.0|-6.8|18.0||P-value is from a 1-sided Pearson chi-square test with Yates' correction with null hypothesis that the difference in proportions Blautix - placebo \<=0 versus the difference is \>0. The significance level for rejection of the null hypotheses is 0.10.|Chi-squared, Corrected|||||18.0|-6.8|0.216
72619792|NCT02554474|144770725|SUPERIORITY||Adjusted difference in mean change|9.4|||||TWO_SIDED|95.0|-0.5|19.3||||||We performed an intent-to-treat analysis. For the main comparison, we used analysis of covariance (ANCOVA) to estimate an adjusted mean difference comparing time in MVPA at 9 weeks (primary end point) between groups, adjusting for baseline MVPA, diagnosis, and blocking.||19.3|-0.5|
72619793|NCT02554474|144770726|SUPERIORITY||Adjusted difference in mean change|-10.4|||||TWO_SIDED|95.0|-53.4|32.6||||||We performed an intent-to-treat analysis. For the main comparison, we used analysis of covariance (ANCOVA) to estimate an adjusted mean difference comparing sedentary time at 9 weeks (primary end point) between groups, adjusting for baseline sedentary time, diagnosis, and blocking.||32.6|-53.4|
72619794|NCT02554474|144770727|SUPERIORITY||Adjusted difference in mean change|-0.31|||||TWO_SIDED|95.0|-0.63|0.01||||||We performed an intent-to-treat analysis. For the main comparison, we used analysis of covariance (ANCOVA) to estimate an adjusted mean difference comparing time in the Fatigue Severity Scale at 9 weeks (primary end point) between groups, adjusting for baseline fatigue score, diagnosis, and blocking.||0.01|-0.63|
72451121|NCT03364127|144423091|SUPERIORITY||Mean Difference (Net)|1.16||||0.436|TWO_SIDED|95.0|-1.76|4.09|||ANCOVA|Full information maximum likelihood for missing data and to retain participants for intention to treat model. Adjusted for baseline value.||||4.09|-1.76|0.436
72561964|NCT00683592|144654864|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean Change|-2.5||||0.009|TWO_SIDED|95.0|-4.4|-0.6|||ANCOVA|||The model was an analysis of covariance (ANCOVA), with terms for treatment group and center, adjusting for baseline MADRS total score. Missing values at week 8 were handled using the last observation carried forward (LOCF) approach.||-0.6|-4.4|0.009
72561965|NCT00683592|144654865|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean Change|-1.6||||0.026|TWO_SIDED|95.0|-3.1|-0.2|||ANCOVA|||The model was an analysis of covariance (ANCOVA), with terms for treatment group and center, adjusting for baseline HAM-D 17 total score. Missing values at week 8 were handled using the last observation carried forward (LOCF) approach.||-0.2|-3.1|0.026
72619795|NCT02554474|144770728|SUPERIORITY||Adjusted difference in mean change|-2.45|||||TWO_SIDED|95.0|-4.78|-0.13||||||We performed an intent-to-treat analysis. For the main comparison, we used analysis of covariance (ANCOVA) to estimate an adjusted mean difference comparing pain at 9 weeks (primary end point) between groups, adjusting for pain score, diagnosis, and blocking.||-0.13|-4.78|
72451122|NCT03364127|144423092|SUPERIORITY||Hazard Ratio (HR)|2.72||||0.017|TWO_SIDED|95.0|1.13|6.54||Kaplan-Meier curves by treatment arm were examined to determine the rates of return to baseline over the 12-week follow-up period .|Log Rank|||Goal was to assess duration of effect among those who showed a response to the intervention (1.5 or greater decrease in PIN).||6.54|1.13|0.017
72451123|NCT02163694|144423093|SUPERIORITY|||||||0.003|||||||Log-rank test|||PFS was compared between the treatment groups using the log-rank test, stratified by prior platinum therapy (Yes versus No) and receptor status (estrogen receptor \[ER\] and/or progesterone receptor \[PgR\] positive versus ER/PgR negative).||||0.003
72451124|NCT02163694|144423093|SUPERIORITY||Stratified Cox proportional hazards|0.728||||0.003|TWO_SIDED|95.0|0.59|0.9|||Stratified Cox proportional hazards|||A Cox proportional hazards model, stratified by prior platinum therapy (Yes versus No) and receptor status (estrogen receptor (ER) and/or progesterone receptor (PgR) positive versus ER/PgR negative) was used to estimate the hazard ratio and 95% confidence interval comparing the two treatment arms.||0.900|0.590|0.003
72451125|NCT02163694|144423094|SUPERIORITY|||||||0.41|||||||Log Rank|||||||0.410
72451126|NCT02163694|144423094|SUPERIORITY||Stratified Cox proportional hazards|0.914||||0.41|TWO_SIDED|95.0|0.737|1.333|||Stratified Cox proportional hazards|||A Cox proportional hazards model, stratified by prior platinum therapy (Yes versus No) and receptor status (estrogen receptor (ER) and/or progesterone receptor (PgR) positive versus ER/PgR negative) was used to estimate the hazard ratio and 95% confidence interval comparing the two treatment arms.||1.333|0.737|0.410
72451127|NCT02163694|144423095|SUPERIORITY|||||||0.202||||||Nominal P value is from Cochran-Mantel-Haenszel test stratified by ER/PgR status and prior platinum therapy use.|Cochran-Mantel-Haenszel|||||||0.202
72451128|NCT02163694|144423096|SUPERIORITY|||||||0.715||||||Nominal P value is from Cochran-Mantel-Haenszel test stratified by ER/PgR status and prior platinum therapy use.|Cochran-Mantel-Haenszel|||||||0.715
72451129|NCT02163694|144423097|SUPERIORITY|||||||0.004|||||||Log Rank|||||||0.004
72451130|NCT02163694|144423097|SUPERIORITY||Stratified Cox proportional hazards|0.737||||0.004|TWO_SIDED|95.0|0.597|0.908|||Stratified Cox proportional hazards|Stratified by prior platinum therapy (yes vs no) and receptor status (ER and/or PgR positive vs ER/PgR negative).||||0.908|0.597|0.004
72451131|NCT04490109|144423142|SUPERIORITY|The ANCOVA model for primary endpoint change from Baseline to Week 4 in average WI-NRS will have treatment group and Baseline weekly average WI-NRS as explanatory variables. Hypothesis will be tested using a Dunnett Testing Method, applying pairwise comparisons of each group to vehicle using a one-sided familywise error rate of 0.10. Treatment effect will be estimated as least squares means using vehicle as reference and adjusted using Dunnett Testing Method and presented with one-sided 90% CI.||||||0.0148|||||||ANCOVA|||Approximately 576 subjects may be enrolled to account for 16.7% drop out rate prior to completing the study. A total of 160 evaluable subjects per group are required to achieve at least 80% power to detect a difference of 0.65 in mean WI-NRS change from Baseline to Week 4 between one of two active doses of B244 and vehicle control when assuming a standard deviation of 2.5 and applying a Dunnett Testing Method at a one-sided familywise error rate of 0.10.||||0.0148
72451132|NCT04490109|144423142|SUPERIORITY|The ANCOVA model for primary endpoint change from Baseline to Week 4 in average WI-NRS will have treatment group and Baseline weekly average WI-NRS as explanatory variables. Hypothesis will be tested using a Dunnett Testing Method, applying pairwise comparisons of each group to vehicle using a one-sided familywise error rate of 0.10. Treatment effect will be estimated as least squares means using vehicle as reference and adjusted using Dunnett Testing Method and presented with one-sided 90% CI.||||||0.0143|||||||ANCOVA|||Approximately 576 subjects may be enrolled to account for 16.7% drop out rate prior to completing the study. A total of 160 evaluable subjects per group are required to achieve at least 80% power to detect a difference of 0.65 in mean WI-NRS change from Baseline to Week 4 between one of two active doses of B244 and vehicle control when assuming a standard deviation of 2.5 and applying a Dunnett Testing Method at a one-sided familywise error rate of 0.10.||||0.0143
72451133|NCT04490109|144423144|SUPERIORITY|||||||0.0205|||||||Regression, Logistic|||The frequency and rate of WI-NRS and AI-NRS responders will be reported and compared between treatment groups using a logistic regression model. Generalized estimating equations to account for repeated measures and within-subject variability may also be applied.||||0.0205
72561966|NCT00683592|144654866|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean Improve|-0.3||||0.004|TWO_SIDED|95.0|-0.5|-0.1|||ANOVA|||The model was an analysis of variance (ANOVA), with terms for treatment group and center. Missing values at week 8 were handled using the last observation carried forward (LOCF) approach.||-0.1|-0.5|0.004
72561967|NCT00683592|144654867|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean Change|-1.2||||0.037|TWO_SIDED|95.0|-2.4|-0.1|||ANCOVA|||The model was an analysis of covariance (ANCOVA), with terms for treatment group and center, adjusting for baseline HAM-A total score. Missing values at week 8 were handled using the last observation carried forward (LOCF) approach.||-0.1|-2.4|0.037
72561968|NCT00683592|144654868|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.134||||0.002|TWO_SIDED|95.0|0.047|0.221|||Cochran-Mantel-Haenszel|||Cochran-Mantel-Haenszel tests were used to compare MADRS response rates between the treatment groups, stratifying by center. The asymptotic confidence interval of the risk difference was estimated by the normal approximation to the binomial distribution.||0.221|0.047|0.002
72561969|NCT00683592|144654869|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.069||||0.066|TWO_SIDED|95.0|-0.008|0.147|||Cochran-Mantel-Haenszel|||Cochran-Mantel-Haenszel tests were used to compare MADRS remission rates between the treatment groups, stratifying by center. The asymptotic confidence interval of the risk difference was estimated by the normal approximation to the binomial distribution.||0.147|-0.008|0.066
72561970|NCT03653026|144654943|SUPERIORITY||Adjusted Response Rate Difference|29.0|||<|0.001|TWO_SIDED|95.0|23.2|34.7||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Cochran-Mantel-Haenszel|Adjusted for Baseline corticosteroid use (yes or no), Baseline Adapted Mayo score (≤ 7 or \> 7), and bio-IR status (bio-IR or non-bio-IR).|Difference = Upadacitinib 45 mg - Placebo|||34.7|23.2|<0.001
72451134|NCT04490109|144423145|SUPERIORITY|||||||0.0044|||||||Mixed Models Analysis|||The difference in treatment groups in change from Baseline values at post-baseline visits will be analyzed using a mixed model with repeated measures.||||0.0044
72451135|NCT04490109|144423145|SUPERIORITY|||||||0.0077|||||||Mixed Models Analysis|||The difference in treatment groups in change from Baseline values at post-baseline visits will be analyzed using a mixed model with repeated measures.||||0.0077
72619796|NCT02554474|144770729|SUPERIORITY||Adjusted difference in mean change|-0.22|||||TWO_SIDED|95.0|-1.78|1.35||||||We performed an intent-to-treat analysis. For the main comparison, we used analysis of covariance (ANCOVA) to estimate an adjusted mean difference comparing the PHQ-9 scores at 9 weeks (primary end point) between groups, adjusting for baseline score, diagnosis, and blocking.||1.35|-1.78|
72451136|NCT04490109|144423146|SUPERIORITY|||||||0.04|||||||Regression, Logistic|||The frequency and rate of WI-NRS and AI-NRS responders will be reported and compared between treatment groups using a logistic regression model. Generalized estimating equations to account for repeated measures and within-subject variability may also be applied.||||0.0400
72451137|NCT04490109|144423146|SUPERIORITY|||||||0.0486|||||||Regression, Logistic|||The frequency and rate of WI-NRS and AI-NRS responders will be reported and compared between treatment groups using a logistic regression model. Generalized estimating equations to account for repeated measures and within-subject variability may also be applied.||||0.0486
72391307|NCT03000439|144289785|OTHER||Difference in LS Mean|-0.01|||||TWO_SIDED|95.0|-9.14|9.13||||||CHQ01-Self Esteem Subscale Standardized Score; DB Week 24: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||9.13|-9.14|
72391308|NCT03000439|144289785|OTHER||Difference in LS Mean|-7.59|||||TWO_SIDED|95.0|-33.87|18.7||||||CHQ01-Self Esteem Subscale Standardized Score; DB Week 48: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||18.70|-33.87|
72391309|NCT03000439|144289785|OTHER||Difference in LS Mean|4.98|||||TWO_SIDED|95.0|-4.81|14.77||||||CHQ01-General Health Subscale Standardized Score; DB Week 24: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||14.77|-4.81|
72451138|NCT04490109|144423148|SUPERIORITY|||||||0.0246|||||||Mixed Models Analysis|||The difference in treatment groups in change from Baseline values at post-baseline visits will be analyzed using a mixed model with repeated measures.||||0.0246
72451139|NCT04490109|144423148|SUPERIORITY|||||||0.0366|||||||Mixed Models Analysis|||The difference in treatment groups in change from Baseline values at post-baseline visits will be analyzed using a mixed model with repeated measures.||||0.0366
72451140|NCT04490109|144423149|SUPERIORITY|||||||0.0467|||||||Regression, Logistic|||The frequency and rate of WI-NRS and AI-NRS responders will be reported and compared between treatment groups using a logistic regression model. Generalized estimating equations to account for repeated measures and within-subject variability may also be applied.||||0.0467
72451141|NCT04490109|144423150|SUPERIORITY|||||||0.0293|||||||Mixed Models Analysis|||The difference in treatment groups in change from Baseline values at post-baseline visits will be analyzed using a mixed model with repeated measures.||||0.0293
72451142|NCT04490109|144423151|SUPERIORITY|||||||0.0045|||||||Mixed Models Analysis|||The difference in treatment groups in change from Baseline values at post-baseline visits will be analyzed using a mixed model with repeated measures.||||0.0045
72451143|NCT04490109|144423151|SUPERIORITY|||||||0.0043|||||||Mixed Models Analysis|||The difference in treatment groups in change from Baseline values at post-baseline visits will be analyzed using a mixed model with repeated measures.||||0.0043
72451144|NCT04490109|144423152|SUPERIORITY|||||||0.0026|||||||Mixed Models Analysis|||The difference in treatment groups in change from Baseline values at post-baseline visits will be analyzed using a mixed model with repeated measures.||||0.0026
72451145|NCT04490109|144423152|SUPERIORITY|||||||0.0005|||||||Mixed Models Analysis|||The difference in treatment groups in change from Baseline values at post-baseline visits will be analyzed using a mixed model with repeated measures.||||0.0005
72451146|NCT04490109|144423153|SUPERIORITY|||||||0.0348|||||||Mixed Models Analysis|||The difference in treatment groups in change from Baseline values at post-baseline visits will be analyzed using a mixed model with repeated measures.||||0.0348
72451147|NCT04490109|144423153|SUPERIORITY|||||||0.0173|||||||Mixed Models Analysis|||The difference in treatment groups in change from Baseline values at post-baseline visits will be analyzed using a mixed model with repeated measures.||||0.0173
72451148|NCT04490109|144423154|SUPERIORITY|||||||0.0228|||||||Regression, Logistic|||Responder rates for IGA and EASI will be summarized using descriptive statistics and analyzed using a logistic regression model at each respective timepoints.||||0.0228
72451149|NCT04490109|144423154|SUPERIORITY|||||||0.0015|||||||Regression, Logistic|||Responder rates for IGA and EASI will be summarized using descriptive statistics and analyzed using a logistic regression model at each respective timepoints.||||0.0015
72619797|NCT02554474|144770730|SUPERIORITY||Adjusted difference in mean change|1.58|||||TWO_SIDED|95.0|-1.02|4.18||||||We performed an intent-to-treat analysis. For the main comparison, we used analysis of covariance (ANCOVA) to estimate an adjusted mean difference comparing the Partners In Health Scale scores at 9 weeks (primary end point) between groups, adjusting for baseline score, diagnosis, and blocking.||4.18|-1.02|
72391310|NCT03000439|144289785|OTHER||Difference in LS Mean|-1.02|||||TWO_SIDED|95.0|-20.31|18.28||||||CHQ01-General Health Subscale Standardized Score; DB Week 48: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||18.28|-20.31|
72391311|NCT03000439|144289785|OTHER||Difference in LS Mean|-0.03|||||TWO_SIDED|95.0|-0.4|0.33||||||CHQ01-Change in Health Subscale Score; DB Week 24: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||0.33|-0.40|
72391312|NCT03000439|144289785|OTHER||Difference in LS Mean|0.48|||||TWO_SIDED|95.0|-0.68|1.65||||||CHQ01-Change in Health Subscale Score; DB Week48: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||1.65|-0.68|
72451150|NCT04490109|144423155|SUPERIORITY|||||||0.0003|||||||Regression, Logistic|||Responder rates for IGA and EASI will be summarized using descriptive statistics and analyzed using a logistic regression model at each respective timepoints.||||0.0003
72451151|NCT04490109|144423156|SUPERIORITY|||||||0.0195|||||||Regression, Logistic|||Responder rates for IGA and EASI will be summarized using descriptive statistics and analyzed using a logistic regression model at each respective timepoints.||||0.0195
72499014|NCT00348140|144528179|SUPERIORITY||Mean Difference (Net)|-0.1||||0.324|TWO_SIDED|95.0|-0.3|0.1|||ANCOVA|||||0.1|-0.3|0.324
72451152|NCT04490109|144423157|SUPERIORITY|||||||0.0365|||||||Regression, Logistic|||Responder rates for IGA and EASI will be summarized using descriptive statistics and analyzed using a logistic regression model at each respective timepoints.||||0.0365
72451153|NCT04490109|144423158|SUPERIORITY|||||||0.0086|||||||Regression, Logistic|||Responder rates for IGA and EASI will be summarized using descriptive statistics and analyzed using a logistic regression model at each respective timepoints.||||0.0086
72451154|NCT04490109|144423158|SUPERIORITY|||||||0.0035|||||||Regression, Logistic|||Responder rates for IGA and EASI will be summarized using descriptive statistics and analyzed using a logistic regression model at each respective timepoints.||||0.0035
72451155|NCT04490109|144423159|SUPERIORITY|||||||0.0074|||||||Regression, Logistic|||Responder rates for IGA and EASI will be summarized using descriptive statistics and analyzed using a logistic regression model at each respective timepoints.||||0.0074
72451156|NCT04490109|144423159|SUPERIORITY|||||||0.0008|||||||Regression, Logistic|||Responder rates for IGA and EASI will be summarized using descriptive statistics and analyzed using a logistic regression model at each respective timepoints.||||0.0008
72451157|NCT05954546|144423208|OTHER||Hazard Ratio (HR)|1.03|||||TWO_SIDED|95.0|0.62|1.72|||||Hazard ratio (HR) was estimated using multivariable Cox proportional hazard models.|Statistical analysis data is presented for Encorafenib+Binimetinib (RWD) relative to Encorafenib+Binimetinib (CTD) (reference).||1.72|0.62|
72451158|NCT03533257|144423214|SUPERIORITY|||||||0.3654|||||||Mixed Models Analysis|The analysis assessed the difference in estimated change-from-baseline values at the 24-week model estimate using LS means estimates from the MMRM.||||||0.3654
72451159|NCT03533257|144423215|SUPERIORITY|||||||0.6698|||||||Mixed Models Analysis|The analysis assessed the difference in estimated change-from-baseline values at the 24-week model estimate using LS means estimates from the MMRM.||||||0.6698
72451160|NCT03533257|144423216|SUPERIORITY|||||||0.3086|||||||Mixed Models Analysis|The analysis assessed the difference in estimated change-from-baseline values at the 24-week model estimate using LS means estimates from the MMRM.||||||0.3086
72451161|NCT03533257|144423217|SUPERIORITY|||||||0.5552|||||||Mixed Models Analysis|The analysis assessed the difference in estimated change-from-baseline values at the 24-week model estimate using LS means estimates from the MMRM.||||||0.5552
72451162|NCT03533257|144423218|SUPERIORITY|||||||0.0361|||||||Mixed Models Analysis|The analysis assessed the difference in estimated change-from-baseline values at the 24-week model estimate using LS means estimates from the MMRM.||||||0.0361
72451163|NCT03533257|144423219|SUPERIORITY|||||||0.3585|||||||Mixed Models Analysis|The analysis assessed the difference in estimated change-from-baseline values at the 24-week model estimate using LS means estimates from the MMRM.||||||0.3585
72451164|NCT03533257|144423220|SUPERIORITY|||||||0.8996|||||||Mixed Models Analysis|The analysis assessed the difference in estimated change-from-baseline values at the 24-week model estimate using LS means estimates from the MMRM.||||||0.8996
72451165|NCT04780581|144423221|EQUIVALENCE|log-rank statistic test.|Odds Ratio (OR)|1.0||||0.984|TWO_SIDED|95.0|0.2|5.1|||Log Rank|||Null hypothesis of equal survival curves. Estimates of rate and risk ratios are shown with 95% confidence intervals. All the p-values are 2-sided and shown without adjustment for multiple testing, and p \< 0.05 was considered statistically significant. The analyses were performed using IBM SPSS Statistics for Windows, Version 26.0 (Armonk, NY, USA: IBM Corp.).||5.1|0.2|0.984
72451166|NCT04780581|144423221|EQUIVALENCE|Log-rank method|Risk Difference (RD)|0.1|||||TWO_SIDED|95.0|-8.8|9.1||||||||9.1|-8.8|
72451167|NCT04780581|144423222|EQUIVALENCE|Cochran-Mantel-Haenszel test|Odds Ratio (OR)|1.1||||0.833|TWO_SIDED|95.0|0.4|3.0|||Chi-squared|||||3.0|0.4|0.833
72451168|NCT04780581|144423222|EQUIVALENCE|Cochran-Mantel-Haenszel test|Risk Difference (RD)|-1.4|||||TWO_SIDED|95.0|-14.2|11.5||||||||11.5|-14.2|
72451169|NCT04780581|144423223|EQUIVALENCE|Cochran-Mantel-Haenszel test|Odds Ratio (OR)|1.5||||0.661|TWO_SIDED|95.0|0.2|9.3|||Chi-squared|||non-invasive mechanical ventilation||9.3|0.2|0.661
72451170|NCT04780581|144423223|EQUIVALENCE|Cochran-Mantel-Haenszel test|Risk Difference (RD)|1.5|||||TWO_SIDED|95.0|-10.2|6.9||||||non-invasive mechanical ventilation||6.9|-10.2|
72451171|NCT04780581|144423223|EQUIVALENCE|Cochran-Mantel-Haenszel test|Odds Ratio (OR)|0.7||||0.549|TWO_SIDED|95.0|0.2|2.2|||Chi-squared|||high-flow oxygen requirements||2.2|0.2|0.549
72451172|NCT04780581|144423223|EQUIVALENCE|Cochran-Mantel-Haenszel test|Risk Difference (RD)|3.4|||||TWO_SIDED|95.0|-8.2|15.1||||||high-flow oxygen requirements||15.1|-8.2|
72451173|NCT04780581|144423223|EQUIVALENCE|Cochran-Mantel-Haenszel test|Odds Ratio (OR)|1.1||||0.809|TWO_SIDED|95.0|0.4|3.3|||Chi-squared|||Invasive mechanical ventilation or intubation requirements analysis||3.3|0.4|0.809
72451174|NCT04780581|144423223|EQUIVALENCE|Cochran-Mantel-Haenszel test|Risk Difference (RD)|-1.0|||||TWO_SIDED|95.0|-13.0|11.1||||||Invasive mechanical ventilation or intubation requirements analysis||11.1|-13.0|
72451175|NCT04780581|144423224|EQUIVALENCE|T-test|Risk Difference (RD)|-0.3||||0.908|TWO_SIDED|95.0|-5.0|5.0|||t-test, 1 sided|||||5|-5|0.908
72451176|NCT04780581|144423225|EQUIVALENCE|Cochran-Mantel-Haenszel test|Odds Ratio (OR)|0.8||||0.758|TWO_SIDED|95.0|0.3|2.5|||Chi-squared|||Secondary infections||2.5|0.3|0.758
72451177|NCT04780581|144423225|EQUIVALENCE|Cochran-Mantel-Haenszel test|Risk Difference (RD)|1.8|||||TWO_SIDED|95.0|-10.1|13.7||||||Secondary infections||13.7|-10.1|
72451178|NCT04780581|144423225|EQUIVALENCE|Cochran-Mantel-Haenszel test|Odds Ratio (OR)|4.2||||0.007|TWO_SIDED|95.0|1.4|12.3|||Chi-squared|||Hyperglycaemia||12.3|1.4|0.007
72499015|NCT00348140|144528179|SUPERIORITY||Mean Difference (Net)|0.0||||0.987|TWO_SIDED|95.0|-0.2|0.2|||ANCOVA|||||0.2|-0.2|0.987
72451179|NCT04780581|144423225|EQUIVALENCE|Cochran-Mantel-Haenszel test|Risk Difference (RD)|-18.9|||||TWO_SIDED|95.0|-31.8|-5.6||||||Hyperglycaemia||-5.6|-31.8|
72451180|NCT04780581|144423225|EQUIVALENCE|Cochran-Mantel-Haenszel test|Risk Difference (RD)|-1.6||||0.319|TWO_SIDED|95.0|-8.5|4.4|||Chi-squared|||Psychotic states||4.4|-8.5|0.319
72619798|NCT02554474|144770731|SUPERIORITY||Adjusted difference in mean change|0.05|||||TWO_SIDED|95.0|-0.05|0.16||||||We performed an intent-to-treat analysis. For the main comparison, analysis of covariance (ANCOVA) was used to estimate an adjusted mean difference comparing the Sitting at Work index scores at 9 weeks (primary end point) between groups, adjusting for baseline score, diagnosis, and blocking.||0.16|-0.05|
72619799|NCT02554474|144770732|SUPERIORITY||Adjusted difference in mean change|0.0|||||TWO_SIDED|95.0|-0.37|0.37||||||We performed an intent-to-treat analysis. For the main comparison, analysis of covariance (ANCOVA) was used to estimate an adjusted mean difference comparing the Sitting at Leisure index scores at 9 weeks (primary end point) between groups, adjusting for baseline score, diagnosis, and blocking.||0.37|-0.37|
72451181|NCT04780581|144423226|EQUIVALENCE|Cochran-Mantel-Haenszel test|Odds Ratio (OR)|1.0||||0.962|TWO_SIDED|95.0|0.4|2.3|||Chi-squared|||||2.3|0.4|0.962
72451182|NCT04780581|144423226|EQUIVALENCE|Cochran-Mantel-Haenszel test|Risk Difference (RD)|0.4|||||TWO_SIDED|95.0|-14.2|14.9||||||||14.9|-14.2|
72451183|NCT01651000|144423228|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
72451184|NCT01651000|144423229|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
72451185|NCT01651000|144423230|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
72451186|NCT02765412|144423232|OTHER|multilevel model|Odds Ratio (OR)|0.67||||0.081|TWO_SIDED|95.0|0.58|0.78||Two-sided test; the a priori threshold being 0.05|Regression, Logistic|Adjusts for age, gender, race, comorbidities, implementation group, travel distance, and VAMC indicator|OR corresponding to the interaction between implementation group and lung cancer risk, a ratio of odds ratios. The OR for screening based on lung cancer risk in the SI group versus the OR for screening based on lung cancer risk in the II group|||0.78|0.58|0.081
72451187|NCT02765412|144423233|OTHER||Median Difference (Net)|-0.15||||0.35|TWO_SIDED|95.0|-0.16|0.46||Two-sided test; the a priori threshold being 0.05|t-test, 2 sided||Satisfaction rating on a scale of 0 to 10; Difference is Arm 1 - Arm 2|Simple t-test comparing mean satisfaction ratings between arms||0.46|-0.16|0.35
72451188|NCT04244175|144423237|SUPERIORITY|RRatio was analyzed using an analysis of covariance (ANCOVA) model including treatment and the Baseline seizure frequency per week as a covariate.|LS Mean Difference|0.11|||=|0.986|TWO_SIDED|90.0|-10.38|10.61|||ANCOVA||CVL-865 25 mg BID - Placebo|CVL-865 25 mg BID vs Placebo||10.61|-10.38|=0.986
72451189|NCT04244175|144423237|SUPERIORITY|RRatio was analyzed using an analysis of covariance (ANCOVA) model including treatment and the Baseline seizure frequency per week as a covariate.|LS Mean Difference|1.42|||=|0.823|TWO_SIDED|90.0|-9.04|11.87|||ANCOVA||CVL-865 7.5 mg BID - Placebo|CVL-865 7.5 mg BID vs Placebo||11.87|-9.04|=0.823
72451190|NCT04244175|144423237|SUPERIORITY|RRatio was analyzed using an analysis of covariance (ANCOVA) model including treatment and the Baseline seizure frequency per week as a covariate.|LS Mean Difference|0.76|||=|0.888|TWO_SIDED|90.0|-8.23|9.76|||ANCOVA||CVL-865 7.5 mg BID / 25 mg BID - Placebo|CVL-865 7.5 mg BID / 25 mg BID vs Placebo||9.76|-8.23|=0.888
72451191|NCT04244175|144423238|SUPERIORITY|The percent reduction relative to Placebo was calculated.|Percent reduction relative to Placebo|4.9|||||TWO_SIDED|90.0|-12.0|19.3||||||CVL-865 25 mg BID vs Placebo||19.3|-12.0|
72451192|NCT04244175|144423238|SUPERIORITY|The percent reduction relative to Placebo was calculated.|Percent reduction relative to Placebo|1.4|||||TWO_SIDED|90.0|-16.1|16.2||||||CVL-865 7.5 mg BID vs Placebo||16.2|-16.1|
72451193|NCT04244175|144423238|SUPERIORITY|The percent reduction relative to Placebo was calculated.|Percent reduction relative to Placebo|3.2|||||TWO_SIDED|90.0|-11.4|15.8||||||CVL-865 7.5 mg BID / 25 mg BID vs Placebo||15.8|-11.4|
72451194|NCT04244175|144423239|SUPERIORITY|A logistic regression with treatment group and Baseline seizure frequency as covariates was used to calculate the Odds ratio, 90% confidence interval, and p-value.|Odds Ratio (OR)|1.27|||=|0.587|TWO_SIDED|90.0|0.616|2.618|||Regression, Logistic|||CVL-865 25 mg BID vs Placebo||2.618|0.616|=0.587
72451195|NCT04244175|144423239|SUPERIORITY|A logistic regression with treatment group and Baseline seizure frequency as covariates was used to calculate the Odds ratio, 90% confidence interval, and p-value.|Odds Ratio (OR)|1.303|||=|0.554|TWO_SIDED|90.0|0.624|2.723|||Regression, Logistic|||CVL-865 7.5 mg BID vs Placebo||2.723|0.624|=0.554
72451196|NCT04244175|144423239|SUPERIORITY|A logistic regression with treatment group and Baseline seizure frequency as covariates was used to calculate the Odds ratio, 90% confidence interval, and p-value.|Odds Ratio (OR)|1.286|||=|0.513|TWO_SIDED|90.0|0.684|2.42|||Regression, Logistic|||CVL-865 7.5 mg BID / 25 mg BID vs Placebo||2.420|0.684|=0.513
72451197|NCT04244175|144423240|SUPERIORITY|The p-value is from Fisher's exact test for number of responders.|||||>|0.999|||||||Fisher's exact test|||CVL-865 25 mg BID vs Placebo||||>0.999
72451198|NCT04244175|144423240|SUPERIORITY|The p-value is from Fisher's exact test for number of responders.|||||=|0.618|||||||Fisher's exact test|||CVL-865 7.5 mg BID vs Placebo||||=0.618
72451199|NCT04244175|144423240|SUPERIORITY|The p-value is from Fisher's exact test for number of responders.|||||=|0.422|||||||Fisher's exact test|||CVL-865 7.5 mg BID / 25 mg BID vs Placebo||||=0.422
72451200|NCT04244175|144423242|SUPERIORITY|The PGI-C score over time was analyzed using a Mixed Model for Repeated Measures (MMRM) analysis. Treatment group, visit, and the interaction between treatment group and visit was included as fixed factors in the MMRM. Participant was included as a random effect, and an unstructured covariance structure was used for the repeated measures.|LS Mean Difference|-0.5|||=|0.021|TWO_SIDED|90.0|-0.8|-0.1|||Mixed Model for Repeated Measures (MMRM)||CVL-865 25 mg BID - Placebo (Day 15)|CVL-865 25 mg BID vs Placebo (Day 15)||-0.1|-0.8|=0.021
72469738|NCT02201901|144463157|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Binomial test|P-value is from the 2-sided exact 1-sample binomial test for the superiority of SOF/VEL 24 weeks (Group 3) over prespecified rate of 1%.||A sample size of 75 participants per treatment group would provide over 99% power to detect 40% improvement in SVR12 rate from the assumed spontaneous rate of 1% or less using a 2-sided exact 1-sample binomial test at significance level of 0.0167.||||<0.001
72451201|NCT04244175|144423242|SUPERIORITY|The PGI-C score over time was analyzed using a Mixed Model for Repeated Measures (MMRM) analysis. Treatment group, visit, and the interaction between treatment group and visit was included as fixed factors in the MMRM. Participant was included as a random effect, and an unstructured covariance structure was used for the repeated measures.|LS Mean Difference|-0.2|||=|0.342|TWO_SIDED|90.0|-0.5|0.1|||Mixed Model for Repeated Measures (MMRM)||CVL-865 7.5 mg BID - Placebo (Day 15)|CVL-865 7.5 mg BID vs Placebo (Day 15)||0.1|-0.5|=0.342
72451202|NCT04244175|144423242|SUPERIORITY|The PGI-C score over time was analyzed using a Mixed Model for Repeated Measures (MMRM) analysis. Treatment group, visit, and the interaction between treatment group and visit was included as fixed factors in the MMRM. Participant was included as a random effect, and an unstructured covariance structure was used for the repeated measures.|LS Mean Difference|-0.3|||=|0.059|TWO_SIDED|90.0|-0.6|0.0|||Mixed Model for Repeated Measures (MMRM)||CVL-865 7.5 mg BID / 25 mg BID - Placebo (Day 15)|CVL-865 7.5 mg BID / 25 mg BID vs Placebo (Day 15)||0.0|-0.6|=0.059
72451203|NCT04244175|144423242|SUPERIORITY|The PGI-C score over time was analyzed using a Mixed Model for Repeated Measures (MMRM) analysis. Treatment group, visit, and the interaction between treatment group and visit was included as fixed factors in the MMRM. Participant was included as a random effect, and an unstructured covariance structure was used for the repeated measures.|LS Mean Difference|-0.5|||=|0.04|TWO_SIDED|90.0|-0.9|-0.1|||Mixed Model for Repeated Measures (MMRM)||CVL-865 25 mg BID - Placebo (Day 43)|CVL-865 25 mg BID vs Placebo (Day 43)||-0.1|-0.9|=0.040
72451204|NCT04244175|144423242|SUPERIORITY|The PGI-C score over time was analyzed using a Mixed Model for Repeated Measures (MMRM) analysis. Treatment group, visit, and the interaction between treatment group and visit was included as fixed factors in the MMRM. Participant was included as a random effect, and an unstructured covariance structure was used for the repeated measures.|LS Mean Difference|-0.4|||=|0.152|TWO_SIDED|90.0|-0.8|0.1|||Mixed Model for Repeated Measures (MMRM)||CVL-865 7.5 mg BID - Placebo (Day 43)|CVL-865 7.5 mg BID vs Placebo (Day 43)||0.1|-0.8|=0.152
72451205|NCT04244175|144423242|SUPERIORITY|The PGI-C score over time was analyzed using a Mixed Model for Repeated Measures (MMRM) analysis. Treatment group, visit, and the interaction between treatment group and visit was included as fixed factors in the MMRM. Participant was included as a random effect, and an unstructured covariance structure was used for the repeated measures.|LS Mean Difference|-0.4|||=|0.044|TWO_SIDED|90.0|-0.8|-0.1|||Mixed Model for Repeated Measures (MMRM)||CVL-865 7.5 mg BID / 25 mg BID - Placebo (Day 43)|CVL-865 7.5 mg BID / 25 mg BID vs Placebo (Day 43)||-0.1|-0.8|=0.044
72451206|NCT04244175|144423242|SUPERIORITY|The PGI-C score over time was analyzed using a Mixed Model for Repeated Measures (MMRM) analysis. Treatment group, visit, and the interaction between treatment group and visit was included as fixed factors in the MMRM. Participant was included as a random effect, and an unstructured covariance structure was used for the repeated measures.|LS Mean Difference|-0.3|||=|0.199|TWO_SIDED|90.0|-0.7|0.1|||Mixed Model for Repeated Measures (MMRM)||CVL-865 25 mg BID - Placebo (Day 71)|CVL-865 25 mg BID vs Placebo (Day 71)||0.1|-0.7|=0.199
72619800|NCT02554474|144770733|SUPERIORITY||Adjusted difference in mean change|0.54|||||TWO_SIDED|95.0|0.08|0.99||||||We performed an intent-to-treat analysis. For the main comparison, analysis of covariance (ANCOVA) was used to estimate an adjusted mean difference comparing the Walking index scores at 9 weeks (primary end point) between groups, adjusting for baseline score, diagnosis, and blocking.||0.99|0.08|
72451207|NCT04244175|144423242|SUPERIORITY|The PGI-C score over time was analyzed using a Mixed Model for Repeated Measures (MMRM) analysis. Treatment group, visit, and the interaction between treatment group and visit was included as fixed factors in the MMRM. Participant was included as a random effect, and an unstructured covariance structure was used for the repeated measures.|LS Mean Difference|-0.3|||=|0.171|TWO_SIDED|90.0|-0.7|0.1|||Mixed Model for Repeated Measures (MMRM)||CVL-865 7.5 mg BID - Placebo (Day 71)|CVL-865 7.5 mg BID vs Placebo (Day 71)||0.1|-0.7|=0.171
72451208|NCT04244175|144423242|SUPERIORITY|The PGI-C score over time was analyzed using a Mixed Model for Repeated Measures (MMRM) analysis. Treatment group, visit, and the interaction between treatment group and visit was included as fixed factors in the MMRM. Participant was included as a random effect, and an unstructured covariance structure was used for the repeated measures.|LS Mean Difference|-0.3|||=|0.125|TWO_SIDED|90.0|-0.7|0.0|||Mixed Model for Repeated Measures (MMRM)||CVL-865 7.5 mg BID / 25 mg BID - Placebo (Day 71)|CVL-865 7.5 mg BID / 25 mg BID vs Placebo (Day 71)||0.0|-0.7|=0.125
72451209|NCT04244175|144423243|SUPERIORITY|The CGI-S score over time was analyzed using a Mixed Model for Repeated Measures (MMRM) analysis. Treatment group, visit, and the interaction between treatment group and visit was included as fixed factors in the MMRM. Participant was included as a random effect, and an unstructured covariance structure was used for the repeated measures.|LS Mean Difference|0.0|||=|0.767|TWO_SIDED|90.0|-0.3|0.2|||Mixed Model for Repeated Measures (MMRM)||CVL-865 25 mg BID - Placebo (Day 15)|CVL-865 25 mg BID vs Placebo (Day 15)||0.2|-0.3|=0.767
72451210|NCT04244175|144423243|SUPERIORITY|The CGI-S score over time was analyzed using a Mixed Model for Repeated Measures (MMRM) analysis. Treatment group, visit, and the interaction between treatment group and visit was included as fixed factors in the MMRM. Participant was included as a random effect, and an unstructured covariance structure was used for the repeated measures.|LS Mean Difference|0.2|||=|0.178|TWO_SIDED|90.0|0.0|0.5|||Mixed Model for Repeated Measures (MMRM)||CVL-865 7.5 mg BID - Placebo (Day 15)|CVL-865 7.5 mg BID vs Placebo (Day 15)||0.5|0.0|=0.178
72451211|NCT04244175|144423243|SUPERIORITY|The CGI-S score over time was analyzed using a Mixed Model for Repeated Measures (MMRM) analysis. Treatment group, visit, and the interaction between treatment group and visit was included as fixed factors in the MMRM. Participant was included as a random effect, and an unstructured covariance structure was used for the repeated measures.|LS Mean Difference|0.1|||=|0.542|TWO_SIDED|90.0|-0.1|0.3|||Mixed Model for Repeated Measures (MMRM)||CVL-865 7.5 mg BID / 25 mg BID - Placebo (Day 15)|CVL-865 7.5 mg BID / 25 mg BID vs Placebo (Day 15)||0.3|-0.1|=0.542
72451212|NCT04244175|144423243|SUPERIORITY|The CGI-S score over time was analyzed using a Mixed Model for Repeated Measures (MMRM) analysis. Treatment group, visit, and the interaction between treatment group and visit was included as fixed factors in the MMRM. Participant was included as a random effect, and an unstructured covariance structure was used for the repeated measures.|LS Mean Difference|-0.3|||=|0.106|TWO_SIDED|90.0|-0.6|0.0|||Mixed Model for Repeated Measures (MMRM)||CVL-865 25 mg BID - Placebo (Day 43)|CVL-865 25 mg BID vs Placebo (Day 43)||0.0|-0.6|=0.106
72619801|NCT02770365|144770734|EQUIVALENCE|provides 85% power of success|Equivalence ratio|1.14|||||TWO_SIDED|90.0|-2.92|12.53|||Wald's method|||||12.53|-2.92|
72451213|NCT04244175|144423243|SUPERIORITY|The CGI-S score over time was analyzed using a Mixed Model for Repeated Measures (MMRM) analysis. Treatment group, visit, and the interaction between treatment group and visit was included as fixed factors in the MMRM. Participant was included as a random effect, and an unstructured covariance structure was used for the repeated measures.|LS Mean Difference|0.1|||=|0.663|TWO_SIDED|90.0|-0.2|0.4|||Mixed Model for Repeated Measures (MMRM)||CVL-865 7.5 mg BID - Placebo (Day 43)|CVL-865 7.5 mg BID vs Placebo (Day 43)||0.4|-0.2|=0.663
72451214|NCT04244175|144423243|SUPERIORITY|The CGI-S score over time was analyzed using a Mixed Model for Repeated Measures (MMRM) analysis. Treatment group, visit, and the interaction between treatment group and visit was included as fixed factors in the MMRM. Participant was included as a random effect, and an unstructured covariance structure was used for the repeated measures.|LS Mean Difference|-0.1|||=|0.488|TWO_SIDED|90.0|-0.4|0.2|||Mixed Model for Repeated Measures (MMRM)||CVL-865 7.5 mg BID / 25 mg BID - Placebo (Day 43)|CVL-865 7.5 mg BID / 25 mg BID vs Placebo (Day 43)||0.2|-0.4|=0.488
72451215|NCT04244175|144423243|SUPERIORITY|The CGI-S score over time was analyzed using a Mixed Model for Repeated Measures (MMRM) analysis. Treatment group, visit, and the interaction between treatment group and visit was included as fixed factors in the MMRM. Participant was included as a random effect, and an unstructured covariance structure was used for the repeated measures.|LS Mean Difference|-0.3|||=|0.1|TWO_SIDED|90.0|-0.7|0.0|||Mixed Model for Repeated Measures (MMRM)||CVL-865 25 mg BID - Placebo (Day 71)|CVL-865 25 mg BID vs Placebo (Day 71)||0.0|-0.7|=0.100
72451216|NCT04244175|144423243|SUPERIORITY|The CGI-S score over time was analyzed using a Mixed Model for Repeated Measures (MMRM) analysis. Treatment group, visit, and the interaction between treatment group and visit was included as fixed factors in the MMRM. Participant was included as a random effect, and an unstructured covariance structure was used for the repeated measures.|LS Mean Difference|0.0|||=|0.969|TWO_SIDED|90.0|-0.3|0.3|||Mixed Model for Repeated Measures (MMRM)||CVL-865 7.5 mg BID - Placebo (Day 71)|CVL-865 7.5 mg BID vs Placebo (Day 71)||0.3|-0.3|=0.969
72451217|NCT04244175|144423243|SUPERIORITY|The CGI-S score over time was analyzed using a Mixed Model for Repeated Measures (MMRM) analysis. Treatment group, visit, and the interaction between treatment group and visit was included as fixed factors in the MMRM. Participant was included as a random effect, and an unstructured covariance structure was used for the repeated measures.|LS Mean Difference|-0.2|||=|0.344|TWO_SIDED|90.0|-0.4|0.1|||Mixed Model for Repeated Measures (MMRM)||CVL-865 7.5 mg BID / 25 mg BID - Placebo (Day 71)|CVL-865 7.5 mg BID / 25 mg BID vs Placebo (Day 71)||0.1|-0.4|=0.344
72451218|NCT04244175|144423244|SUPERIORITY|The CGI-I score over time was analyzed using a Mixed Model for Repeated Measures (MMRM) analysis. Treatment group, visit, and the interaction between treatment group and visit was included as fixed factors in the MMRM. Participant was included as a random effect, and an unstructured covariance structure was used for the repeated measures.|LS Mean Difference|-0.4|||=|0.01|TWO_SIDED|90.0|-0.7|-0.2|||Mixed Model for Repeated Measures (MMRM)||CVL-865 25 mg BID - Placebo (Day 15)|CVL-865 25 mg BID vs Placebo (Day 15)||-0.2|-0.7|=0.010
72451219|NCT04244175|144423244|SUPERIORITY|The CGI-I score over time was analyzed using a Mixed Model for Repeated Measures (MMRM) analysis. Treatment group, visit, and the interaction between treatment group and visit was included as fixed factors in the MMRM. Participant was included as a random effect, and an unstructured covariance structure was used for the repeated measures.|LS Mean Difference|-0.1|||=|0.376|TWO_SIDED|90.0|-0.4|0.1|||Mixed Model for Repeated Measures (MMRM)||CVL-865 7.5 mg BID - Placebo (Day 15)|CVL-865 7.5 mg BID vs Placebo (Day 15)||0.1|-0.4|=0.376
72451220|NCT04244175|144423244|SUPERIORITY|The CGI-I score over time was analyzed using a Mixed Model for Repeated Measures (MMRM) analysis. Treatment group, visit, and the interaction between treatment group and visit was included as fixed factors in the MMRM. Participant was included as a random effect, and an unstructured covariance structure was used for the repeated measures.|LS Mean Difference|-0.3|||=|0.044|TWO_SIDED|90.0|-0.5|-0.1|||Mixed Model for Repeated Measures (MMRM)||CVL-865 7.5 mg BID / 25 mg BID - Placebo (Day 15)|CVL-865 7.5 mg BID / 25 mg BID vs Placebo (Day 15)||-0.1|-0.5|=0.044
72451221|NCT04244175|144423244|SUPERIORITY|The CGI-I score over time was analyzed using a Mixed Model for Repeated Measures (MMRM) analysis. Treatment group, visit, and the interaction between treatment group and visit was included as fixed factors in the MMRM. Participant was included as a random effect, and an unstructured covariance structure was used for the repeated measures.|LS Mean Difference|-0.6|||=|0.005|TWO_SIDED|90.0|-1.0|-0.3|||Mixed Model for Repeated Measures (MMRM)||CVL-865 25 mg BID - Placebo (Day 43)|CVL-865 25 mg BID vs Placebo (Day 43)||-0.3|-1.0|=0.005
72451222|NCT04244175|144423244|SUPERIORITY|The CGI-I score over time was analyzed using a Mixed Model for Repeated Measures (MMRM) analysis. Treatment group, visit, and the interaction between treatment group and visit was included as fixed factors in the MMRM. Participant was included as a random effect, and an unstructured covariance structure was used for the repeated measures.|LS Mean Difference|-0.1|||=|0.549|TWO_SIDED|90.0|-0.5|0.2|||Mixed Model for Repeated Measures (MMRM)||CVL-865 7.5 mg BID - Placebo (Day 43)|CVL-865 7.5 mg BID vs Placebo (Day 43)||0.2|-0.5|=0.549
72469739|NCT01431950|144463169|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.077||||||95.0|-0.039|0.192||||||||0.192|-0.039|
72469740|NCT01867047|144463208|SUPERIORITY|||||||0.14|||||||t-test, 2 sided|||Statistical analysis for intraoperative mild hypotension||||0.140
72469741|NCT01867047|144463208|SUPERIORITY|||||||1|||||||t-test, 2 sided|||Statistical analysis for postoperative mild hypotension||||1.000
72469742|NCT01867047|144463210|SUPERIORITY|||||||0.102|||||||t-test, 2 sided|||Analysis for number of participants given vasopressors intraoperatively||||0.102
72469743|NCT01867047|144463213|SUPERIORITY|||||||0.7|||||||t-test, 2 sided|||||||0.700
72469744|NCT01867047|144463214|SUPERIORITY|||||||0.702|||||||t-test, 2 sided|||||||0.702
72469745|NCT00349466|144463215|SUPERIORITY|||||||0.027|||||||ANCOVA|||||||0.027
72469746|NCT00349466|144463216|SUPERIORITY|||||||0.083|||||||ANCOVA|||||||0.083
72469747|NCT00349466|144463217|SUPERIORITY_OR_OTHER_LEGACY|||||||0.028|TWO_SIDED|95.0|||||Fisher Exact|||||||0.028
72469748|NCT00349466|144463218|SUPERIORITY|||||||0.655|||||||Fisher Exact|||||||0.655
72469749|NCT00349466|144463219|SUPERIORITY|||||||0.387|||||||ANCOVA|||||||0.387
72469750|NCT00349466|144463220|SUPERIORITY|||||||0.203|||||||Wilcoxon (Mann-Whitney)|||||||0.203
72469751|NCT00349466|144463221|SUPERIORITY|||||||0.807|||||||ANCOVA|||||||.807
72451223|NCT04244175|144423244|SUPERIORITY|The CGI-I score over time was analyzed using a Mixed Model for Repeated Measures (MMRM) analysis. Treatment group, visit, and the interaction between treatment group and visit was included as fixed factors in the MMRM. Participant was included as a random effect, and an unstructured covariance structure was used for the repeated measures.|LS Mean Difference|-0.4|||=|0.048|TWO_SIDED|90.0|-0.7|-0.1|||Mixed Model for Repeated Measures (MMRM)||CVL-865 7.5 mg BID / 25 mg BID - Placebo (Day 43)|CVL-865 7.5 mg BID / 25 mg BID vs Placebo (Day 43)||-0.1|-0.7|=0.048
72391313|NCT03000439|144289785|OTHER||Difference in LS Mean|2.25|||||TWO_SIDED|95.0|-10.59|15.1||||||CHQ01-Emotional Impact on Parent Subscale Standardized Score; DB Week 24: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||15.10|-10.59|
72391314|NCT03000439|144289785|OTHER||Difference in LS Mean|-25.07|||||TWO_SIDED|95.0|-60.96|10.82||||||CHQ01-Emotional Impact on Parent Subscale Standardized Score; DB Week 48: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||10.82|-60.96|
72391315|NCT03000439|144289785|OTHER||Difference in LS Mean|1.87|||||TWO_SIDED|95.0|-13.55|17.29||||||CHQ01-Time Impact on Parent Subscale Standardized Score; DB Week 24: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||17.29|-13.55|
72391316|NCT03000439|144289785|OTHER||Difference in LS Mean|-9.19|||||TWO_SIDED|95.0|-48.91|30.53||||||CHQ01-Time Impact on Parent Subscale Standardized Score; DB Week 48: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||30.53|-48.91|
72391317|NCT03000439|144289785|OTHER||Difference in LS Mean|-3.97|||||TWO_SIDED|95.0|-12.84|4.9||||||CHQ01-Family Activities Subscale Standardized Score; DB Week 24: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||4.90|-12.84|
72391318|NCT03000439|144289785|OTHER||Difference in LS Mean|-9.3|||||TWO_SIDED|95.0|-32.35|13.75||||||CHQ01-Family Activities Subscale Standardized Score; DB Week 48: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||13.75|-32.35|
72451224|NCT04244175|144423244|SUPERIORITY|The CGI-I score over time was analyzed using a Mixed Model for Repeated Measures (MMRM) analysis. Treatment group, visit, and the interaction between treatment group and visit was included as fixed factors in the MMRM. Participant was included as a random effect, and an unstructured covariance structure was used for the repeated measures.|LS Mean Difference|-0.6|||=|0.005|TWO_SIDED|90.0|-1.0|-0.3|||Mixed Model for Repeated Measures (MMRM)||CVL-865 25 mg BID - Placebo (Day 71)|CVL-865 25 mg BID vs Placebo (Day 71)||-0.3|-1.0|=0.005
72451225|NCT04244175|144423244|SUPERIORITY|The CGI-I score over time was analyzed using a Mixed Model for Repeated Measures (MMRM) analysis. Treatment group, visit, and the interaction between treatment group and visit was included as fixed factors in the MMRM. Participant was included as a random effect, and an unstructured covariance structure was used for the repeated measures.|LS Mean Difference|-0.1|||=|0.549|TWO_SIDED|90.0|-0.5|0.2|||Mixed Model for Repeated Measures (MMRM)||CVL-865 7.5 mg BID - Placebo (Day 71)|CVL-865 7.5 mg BID vs Placebo (Day 71)||0.2|-0.5|=0.549
72451226|NCT04244175|144423244|SUPERIORITY|The CGI-I score over time was analyzed using a Mixed Model for Repeated Measures (MMRM) analysis. Treatment group, visit, and the interaction between treatment group and visit was included as fixed factors in the MMRM. Participant was included as a random effect, and an unstructured covariance structure was used for the repeated measures.|LS Mean Difference|-0.4|||=|0.048|TWO_SIDED|90.0|-0.7|-0.1|||Mixed Model for Repeated Measures (MMRM)||CVL-865 7.5 mg BID / 25 mg BID - Placebo (Day 71)|CVL-865 7.5 mg BID / 25 mg BID vs Placebo (Day 71)||-0.1|-0.7|=0.048
72451227|NCT04244175|144423245|SUPERIORITY|Changes from Baseline in QOLIE-31 Overall Scores was compared using an ANCOVA model with the Baseline score as a covariate and treatment group included in the model as fixed effects in the mITT population. This estimand included available post-Baseline response data that occurred before discontinuation of treatment or the addition of rescue medication.|LS Mean Difference|-0.49|||=|0.829|TWO_SIDED|90.0|-4.23|3.26|||ANCOVA||CVL-865 25 mg BID - Placebo|CVL-865 25 mg BID vs Placebo||3.26|-4.23|=0.829
72391319|NCT03000439|144289785|OTHER||Difference in LS Mean|-3.52|||||TWO_SIDED|95.0|-14.84|7.81||||||CHQ01-Family Cohesion Subscale Standardized Score; DB Week 24: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||7.81|-14.84|
72451228|NCT04244175|144423245|SUPERIORITY|Changes from Baseline in QOLIE-31 Overall Scores was compared using an ANCOVA model with the Baseline score as a covariate and treatment group included in the model as fixed effects in the mITT population. This estimand included available post-Baseline response data that occurred before discontinuation of treatment or the addition of rescue medication.|LS Mean Difference|-0.2|||=|0.927|TWO_SIDED|90.0|-3.87|3.46|||ANCOVA||CVL-865 7.5 mg BID - Placebo|CVL-865 7.5 mg BID vs Placebo||3.46|-3.87|=0.927
72391320|NCT03000439|144289785|OTHER||Difference in LS Mean|-20.42|||||TWO_SIDED|95.0|-79.03|38.18||||||CHQ01-Family Cohesion Subscale Standardized Score; DB Week 48: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||38.18|-79.03|
72391321|NCT03000439|144289788|OTHER||Difference in LS Mean|-0.24|||||TWO_SIDED|95.0|-1.02|0.54||||||CHAQ-Discomfort Index at Week 4: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||0.54|-1.02|
72391322|NCT03000439|144289788|OTHER||Difference in LS Mean|0.54|||||TWO_SIDED|95.0|-0.49|1.57||||||CHAQ-Discomfort Index at Week 8: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||1.57|-0.49|
72499016|NCT00348140|144528180|SUPERIORITY||Mean Difference (Net)|0.05||||0.038|TWO_SIDED|95.0|0.0|0.1|||ANCOVA|||||0.10|0.00|0.038
72499017|NCT00348140|144528180|SUPERIORITY||Mean Difference (Net)|0.13|||<|0.001|TWO_SIDED|95.0|0.08|0.18|||ANCOVA|||||0.18|0.08|<0.001
72451229|NCT04244175|144423245|SUPERIORITY|Changes from Baseline in QOLIE-31 Overall Scores was compared using an ANCOVA model with the Baseline score as a covariate and treatment group included in the model as fixed effects in the mITT population. This estimand included available post-Baseline response data that occurred before discontinuation of treatment or the addition of rescue medication.|LS Mean Difference|-0.35|||=|0.859|TWO_SIDED|90.0|-3.57|2.88|||ANCOVA||CVL-865 7.5 mg BID / 25 mg BID - Placebo|CVL-865 7.5 mg BID / 25 mg BID vs Placebo||2.88|-3.57|=0.859
72451230|NCT04244175|144423246|SUPERIORITY|The Least Square Means (LS Means), difference in LS Means, 90% confidence interval for the difference, and the p-value for the difference are from an analysis of covariance (ANCOVA) model with fixed effects for treatment and Baseline score.|LS Mean Difference|-0.013|||=|0.788|TWO_SIDED|90.0|-0.096|0.069|||ANCOVA||CVL-865 25 mg BID - Placebo (HUI-2)|CVL-865 25 mg BID vs Placebo (HUI-2)||0.069|-0.096|=0.788
72451231|NCT04244175|144423246|SUPERIORITY|The Least Square Means (LS Means), difference in LS Means, 90% confidence interval for the difference, and the p-value for the difference are from an analysis of covariance (ANCOVA) model with fixed effects for treatment and Baseline score.|LS Mean Difference|0.077|||=|0.126|TWO_SIDED|90.0|-0.006|0.16|||ANCOVA||CVL-865 7.5 mg BID - Placebo (HUI-2)|CVL-865 7.5 mg BID vs Placebo (HUI-2)||0.160|-0.006|=0.126
72451232|NCT04244175|144423246|SUPERIORITY|The Least Square Means (LS Means), difference in LS Means, 90% confidence interval for the difference, and the p-value for the difference are from an analysis of covariance (ANCOVA) model with fixed effects for treatment and Baseline score.|LS Mean Difference|0.032|||=|0.461|TWO_SIDED|90.0|-0.039|0.103|||ANCOVA||CVL-865 7.5 mg BID / 25 mg BID - Placebo (HUI-2)|CVL-865 7.5 mg BID / 25 mg BID vs Placebo (HUI-2)||0.103|-0.039|=0.461
72499018|NCT00348140|144528193|SUPERIORITY||Mean Difference (Net)|-0.1||||0.748|TWO_SIDED|95.0|-0.4|0.3|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|For Week 8||0.3|-0.4|0.748
72451233|NCT04244175|144423246|SUPERIORITY|The Least Square Means (LS Means), difference in LS Means, 90% confidence interval for the difference, and the p-value for the difference are from an analysis of covariance (ANCOVA) model with fixed effects for treatment and Baseline score.|LS Mean Difference|-0.032|||=|0.661|TWO_SIDED|90.0|-0.154|0.089|||ANCOVA||CVL-865 25 mg BID - Placebo (HUI-3)|CVL-865 25 mg BID vs Placebo (HUI-3)||0.089|-0.154|=0.661
72451234|NCT04244175|144423246|SUPERIORITY|The Least Square Means (LS Means), difference in LS Means, 90% confidence interval for the difference, and the p-value for the difference are from an analysis of covariance (ANCOVA) model with fixed effects for treatment and Baseline score.|LS Mean Difference|0.115|||=|0.124|TWO_SIDED|90.0|-0.008|0.237|||ANCOVA||CVL-865 7.5 mg BID - Placebo (HUI-3)|CVL-865 7.5 mg BID vs Placebo (HUI-3)||0.237|-0.008|=0.124
72451235|NCT04244175|144423246|SUPERIORITY|The Least Square Means (LS Means), difference in LS Means, 90% confidence interval for the difference, and the p-value for the difference are from an analysis of covariance (ANCOVA) model with fixed effects for treatment and Baseline score.|LS Mean Difference|0.041|||=|0.518|TWO_SIDED|90.0|-0.064|0.146|||ANCOVA||CVL-865 7.5 mg BID / 25 mg BID - Placebo (HUI-3)|CVL-865 7.5 mg BID / 25 mg BID vs Placebo (HUI-3)||0.146|-0.064|=0.518
72451236|NCT03781089|144423275|OTHER|||||||0.024|||||||Wilcoxon (Mann-Whitney)|||||||0.024
72451237|NCT03781089|144423276|OTHER|||||||0.024|||||||Wilcoxon (Mann-Whitney)|||||||0.024
72451238|NCT04704869|144423293|SUPERIORITY||Risk Ratio (RR)|0.97|||||TWO_SIDED|95.0|0.81|1.17||||||||1.17|0.81|
72451239|NCT03662022|144423312|SUPERIORITY||incidence rate ratio|0.95|||<|0.017|TWO_SIDED|98.3|0.4|2.23||The significance level was determined at 0.017, to account for the fact that we made three comparisons, thus conclusions can be drawn by examining if the 98.3% CI for the incidence rate ratio (IRR) contains the critical value of 1.|Mixed Models Analysis|||||2.23|0.40|<0.017
72451240|NCT03662022|144423312|SUPERIORITY||incidence rate ratio|0.8||||0.017|TWO_SIDED|98.3|0.34|1.87|||Mixed Models Analysis|||||1.87|0.34|0.017
72499019|NCT00348140|144528193|SUPERIORITY||Mean Difference (Net)|0.1||||0.617|TWO_SIDED|95.0|-0.3|0.5|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|For Week 8||0.5|-0.3|0.617
72499020|NCT00348140|144528193|SUPERIORITY||Mean Difference (Net)|-0.1||||0.708|TWO_SIDED|95.0|-0.5|0.3|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|Week 16||0.3|-0.5|0.708
72499021|NCT00348140|144528193|SUPERIORITY||Mean Difference (Net)|-0.2||||0.4|TWO_SIDED|95.0|-0.5|0.2|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|Week 16||0.2|-0.5|0.400
72499022|NCT00348140|144528193|SUPERIORITY||Mean Difference (Net)|0.0||||0.928|TWO_SIDED|95.0|-0.4|0.4|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|For Week 24||0.4|-0.4|0.928
72499023|NCT00348140|144528193|SUPERIORITY||Mean Difference (Net)|0.3||||0.178|TWO_SIDED|95.0|-0.1|0.7|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|For Week 24||0.7|-0.1|0.178
72499024|NCT00348140|144528193|SUPERIORITY||Mean Difference (Net)|0.1||||0.626|TWO_SIDED|95.0|-0.3|0.5|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|For Week 36||0.5|-0.3|0.626
72499025|NCT00348140|144528193|SUPERIORITY||Mean Difference (Net)|0.1||||0.608|TWO_SIDED|95.0|-0.3|0.5|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|For Week 36||0.5|-0.3|0.608
72451241|NCT03662022|144423312|SUPERIORITY||incidence rate ratio|0.58|||<|0.017|TWO_SIDED|98.3|0.22|1.56|||Mixed Models Analysis|||||1.56|0.22|<0.017
72451242|NCT03547271|144423351|NON_INFERIORITY|The non-inferiority was demonstrated if the lower limit of the 2-sided 95% confidence interval (CI) was \>1/1.5 for all 4 serogroups.|GMT ratio|0.69|||||TWO_SIDED|95.0|0.565|0.842|||||95% CI of the GMT ratio was calculated using a normal approximation of log-transformed titers.|Statistical analysis for Serogroup A||0.842|0.565|
72451243|NCT03547271|144423351|NON_INFERIORITY|The non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI was \>1/1.5 for all 4 serogroups.|GMT ratio|4.73|||||TWO_SIDED|95.0|4.0|5.58|||||95% CI of the GMT ratio was calculated using a normal approximation of log-transformed titers.|Statistical analysis for Serogroup C||5.58|4.00|
72451244|NCT03547271|144423351|NON_INFERIORITY|The non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI was \>1/1.5 for all 4 serogroups.|Slope|1.54|||||TWO_SIDED|95.0|1.33|1.78|||||95% CI of the GMT ratio was calculated using a normal approximation of log-transformed titers.|Statistical analysis for Serogroup W||1.78|1.33|
72451245|NCT03547271|144423351|NON_INFERIORITY|The non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI was \>1/1.5 for all 4 serogroups.|GMT ratio|1.78|||||TWO_SIDED|95.0|1.55|2.04|||||95% CI of the GMT ratio was calculated using a normal approximation of log-transformed titers.|Statistical analysis for Serogroup Y||2.04|1.55|
72451246|NCT03547271|144423352|NON_INFERIORITY|The non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI was \>-10% for all 4 serogroups.|Difference in percentage of participants|-12.2|||||TWO_SIDED|95.0|-17.74|-6.56|||||95% CI of the difference was calculated from the Wilson score method without continuity correction.|Statistical analysis for Serogroup A||-6.56|-17.74|
72499026|NCT00348140|144528193|SUPERIORITY||Mean Difference (Net)|0.0||||0.865|TWO_SIDED|95.0|-0.5|0.4|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|For Week 48||0.4|-0.5|0.865
72370370|NCT02504216|144251359|SUPERIORITY||Hazard Ratio (HR)|0.88|||=|0.014|TWO_SIDED|95.0|0.79|0.99||P-value (1-sided) is based on the log rank test stratified by type of procedure and clopidogrel use per IxRS assignment with treatment as a factor.|Log Rank|||||0.99|0.79|=0.0140
72451247|NCT03547271|144423352|NON_INFERIORITY|The non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI was \>-10% for all 4 serogroups.|Difference in percentage of participants|6.89|||||TWO_SIDED|95.0|4.44|9.62|||||95% CI of the difference was calculated from the Wilson score method without continuity correction.|Statistical analysis for Serogroup C||9.62|4.44|
72451248|NCT03547271|144423352|NON_INFERIORITY|The non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI was \>-10% for all 4 serogroups.|Difference in percentage of participants|2.07|||||TWO_SIDED|95.0|-0.49|4.7|||||95% CI of the difference was calculated from the Wilson score method without continuity correction|Statistical analysis for Serogroup W||4.70|-0.49|
72451249|NCT03547271|144423352|NON_INFERIORITY|The non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI was \>-10% for all 4 serogroups.|Difference in percentage of participants|3.01|||||TWO_SIDED|95.0|0.34|5.77|||||95% CI of the difference was calculated from the Wilson score method without continuity correction.|Statistical analysis for Serogroup Y||5.77|0.34|
72451250|NCT04835363|144423369|SUPERIORITY|||||||0.029|||||||ANOVA|||||||0.029
72451251|NCT04835363|144423370|SUPERIORITY|||||||0.148|||||||ANOVA|||||||0.148
72451252|NCT04835363|144423371|SUPERIORITY|||||||0.012|||||||ANOVA|||||||0.012
72451253|NCT04835363|144423372|SUPERIORITY|||||||0.078|||||||ANOVA|||||||0.078
72451254|NCT04835363|144423373|SUPERIORITY|||||||0.011|||||||ANOVA|||||||0.011
72451255|NCT04835363|144423374|SUPERIORITY|||||||0.797|||||||ANOVA|||||||0.797
72451256|NCT04835363|144423375|SUPERIORITY|||||||0.358|||||||ANOVA|||||||0.358
72451257|NCT04835363|144423376|SUPERIORITY|||||||0.055|||||||ANOVA|||||||0.055
72451258|NCT04835363|144423377|SUPERIORITY|||||||0.496|||||||ANOVA|||||||0.496
72499027|NCT00348140|144528193|SUPERIORITY||Mean Difference (Net)|0.3||||0.149|TWO_SIDED|95.0|-0.1|0.8|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|For Week 48||0.8|-0.1|0.149
72499028|NCT00516919|144528194|SUPERIORITY_OR_OTHER_LEGACY||F statistic|0.45|||=|0.51||95.0|||||ANCOVA|Covariate = Baseline (pre-treatment) BMI; Degrees of freedom = (1, 76)||Test for group differences in BMI at post-treatment, controlling for baseline BMI.||||=0.51
72451259|NCT04835363|144423378|SUPERIORITY|||||||0.241|||||||ANOVA|||||||0.241
72451260|NCT04835363|144423379|SUPERIORITY|||||||0.004|||||||ANOVA|||||||0.004
72451261|NCT04835363|144423380|SUPERIORITY|||||||0.019|||||||ANOVA|||||||0.019
72451262|NCT04835363|144423381|SUPERIORITY|||||||0.141|||||||ANOVA|||ENGAGEMENT STRATEGIES||||0.141
72451263|NCT04835363|144423381|SUPERIORITY|||||||0.496|||||||ANOVA|||DISENGAGEMENT STRATEGIES||||0.496
72451264|NCT02532621|144423390|NON_INFERIORITY|"Cumulative patency at 6 months was evaluated using the estimated patency from a Kaplan Meier survival analysis. The test statistic took the following form:~Z-test statistic = (P - 0.75) / SE (P) Where, (P) represents the Kaplan Meier estimate of cumulative patency at 6 months, and the standard error SE (P) is estimated using the method of Peto et al (1977)."|Cumulative patency|92.1|||<|0.001|ONE_SIDED|95.0||||A one-sided p-value of 0.025 was considered evidence of statistical significance for the primary study endpoint.|one-sided binomial exact test|||"The primary endpoint was evaluated by comparison with a performance goal of 75% that was determined from medical literature.~The sample size of 158 patients was estimated as follows:~* Kaplan-Meier estimate of cumulative patency rate at 6 months (exact binomial estimation for sample size)~* Type I error (alpha): 0.025 (one-sided)~* 80% Statistical power~* 8% Lost-to-follow up rate"||||<0.001
72451265|NCT02360371|144423396|SUPERIORITY|||||||0.567|||||||Mixed methods|||||||0.567
72451266|NCT02360371|144423397|SUPERIORITY|||||||0.805|||||||Mixed Model|||||||0.805
72499029|NCT00516919|144528194|SUPERIORITY_OR_OTHER_LEGACY||F statistic|0.69|||=|0.41||95.0|||||ANCOVA|Covariate = Baseline (pre-treatment) BMI; Degrees of freedom = (1, 76)||Test for group differences in BMI at 6-month follow-up, controlling for baseline BMI.||||=0.41
72451267|NCT04881110|144423411|SUPERIORITY||Mean Difference (Final Values)|11.2|||<|0.001|TWO_SIDED|95.0|8.0|14.5|||t-test, 2 sided||||To evaluate the change of variables over time, we subtracted the values at the start from values at the end. A 2-sample t test was used to compare differences between the interventions. The χ2 test was used for comparing proportions of participants in the 2 groups who reached the primary end point after the intervention. Relative risks (RRs) and 95%Cis were calculated to demonstrate the relationship between the intervention and the achievement of the primary end point. A 2-sided P \< .05 was considered statistically significant.|14.5|8.0|<0.001
72451268|NCT04881110|144423411|SUPERIORITY||Risk Ratio (RR)|1.91|||<|0.001|TWO_SIDED|95.0|1.26|2.9|||Chi-squared||||To evaluate the change of variables over time, we subtracted the values at the start from values at the end. A 2-sample t test was used to compare differences between the interventions. The χ2 test was used for comparing proportions of participants in the 2 groups who reached the primary end point after the intervention. Relative risks (RRs) and 95%Cis were calculated to demonstrate the relationship between the intervention and the achievement of the primary end point. A 2-sided P \< .05 was considered statistically significant.|2.90|1.26|<0.001
72451269|NCT04881110|144423412|SUPERIORITY||Mean Difference (Final Values)|-0.4||||0.06|TWO_SIDED|95.0|-0.8|0.01|||t-test, 2 sided||||To evaluate the change of variables over time, we subtracted the values at the start from values at the end. A 2-sample t test was used to compare differences between the interventions. The χ2 test was used for comparing proportions of participants in the 2 groups who reached the primary end point after the intervention. Relative risks (RRs) and 95%Cis were calculated to demonstrate the relationship between the intervention and the achievement of the primary end point. A 2-sided P \< .05 was considered statistically significant.|0.01|-0.8|0.06
72499030|NCT00977470|144528202|EQUIVALENCE|All enrolled patients will be included in the intent-to-treat efficacy analyses. Based on historical patients with EGFR mutations treated with gefitinib, we expect median progression-free survival on the erlotinib-alone arm to be approximately 9 months. This trial can detect a difference in proportions alive without progression at 9 months from 50% in the erlotinib arm to 77% in the erlotinib plus HCQ arm, using an alpha of 0.15 and power of 85%, using the two-sided Likelihood Ratio test.||||||0.28|||||||Log Rank|||||||0.28
72499031|NCT01173653|144528234|SUPERIORITY_OR_OTHER||Chi square|23.02|||<|0.05|||||||Chi-squared|||||||<0.05
72619802|NCT02770365|144770735|EQUIVALENCE|the proportion of subjects with treatment success based on the improvement of the Most Bothersome Symptom (MBS) of vulvo-vaginal atrophy at Day 8.|equivalence ratio|0.94||||0.05|TWO_SIDED|90.0|-12.35|4.31|||Wald's method|||||4.31|-12.35|0.05
72619803|NCT02991859|144770743|OTHER||3 parameter Emax model|13.5|||||TWO_SIDED|95.0|9.39|19.39|||||FF E0 (Response of Placebo participants)|||19.39|9.39|
72619804|NCT02991859|144770743|OTHER||3 parameter Emax model|14.44|||||TWO_SIDED|95.0|8.21|25.4|||||Emax-Maximum Dose response|||25.40|8.21|
72619805|NCT02991859|144770743|OTHER||3 parameter Emax model|48.52|||||TWO_SIDED|95.0|18.21|129.32|||||ED50-Dose at which 50% of the maximum dose response reached (mcg)|||129.32|18.21|
72619806|NCT02991859|144770743|OTHER||3 parameter Emax model|13.5|||||TWO_SIDED|95.0|9.39|19.39|||||FP E0-Response of Placebo participants|||19.39|9.39|
72370371|NCT02504216|144251360|SUPERIORITY||Hazard Ratio (HR)|0.72|||<|0.0001|TWO_SIDED|95.0|0.62|0.85||P-value (1-sided) is based on the log rank test stratified by type of procedure and clopidogrel use per IxRS assignment with treatment as a factor.|Log Rank|||||0.85|0.62|<0.0001
72370372|NCT02504216|144251361|SUPERIORITY||Hazard Ratio (HR)|0.89|||=|0.0145|TWO_SIDED|95.0|0.79|0.99||P-value (1-sided) is based on the log rank test stratified by type of procedure and clopidogrel use per IxRS assignment with treatment as a factor.|Log Rank|||||0.99|0.79|=0.0145
72370373|NCT02504216|144251362|SUPERIORITY||Hazard Ratio (HR)|0.86|||=|0.0051|TWO_SIDED|95.0|0.76|0.96||P-value (1-sided) is based on the log rank test stratified by type of procedure and clopidogrel use per IxRS assignment with treatment as a factor.|Log Rank|||||0.96|0.76|=0.0051
72370374|NCT02504216|144251363|SUPERIORITY||Hazard Ratio (HR)|1.08|||=|0.8322|TWO_SIDED|95.0|0.92|1.27||P-value (1-sided) is based on the log rank test stratified by type of procedure and clopidogrel use per IxRS assignment with treatment as a factor.|Log Rank|||||1.27|0.92|=0.8322
72370375|NCT02504216|144251364|SUPERIORITY||Hazard Ratio (HR)|0.61|||=|0.0235|TWO_SIDED|95.0|0.37|1.0||P-value (1-sided) is based on the log rank test stratified by type of procedure and clopidogrel use per IxRS assignment with treatment as a factor.|Log Rank|||||1.00|0.37|=0.0235
72370376|NCT02504216|144251365|OTHER||Hazard Ratio (HR)|1.42|||=|0.0068|TWO_SIDED|95.0|1.1|1.84|||Log Rank|||||1.84|1.10|=0.0068
72370377|NCT02504216|144251366|OTHER||Hazard Ratio (HR)|1.29|||=|0.0979|TWO_SIDED|95.0|0.95|1.76|||Log Rank|||||1.76|0.95|=0.0979
72370378|NCT03237286|144251402|SUPERIORITY|||||||0.0004|||||||Regression, Linear|||||||.0004
72370379|NCT00948441|144251422|SUPERIORITY_OR_OTHER|||||||0.012|TWO_SIDED||||||t-test, 2 sided|||matched pairs T test to compare infection rates during the two study periods||||0.012
72370380|NCT02093819|144251425|SUPERIORITY_OR_OTHER||Slope|1.1313|STANDARD_ERROR_OF_MEAN|0.0633|||TWO_SIDED|90.0|1.0249|1.2376|||||Evaluation of dose proportionality - all dose groups. Number of subjects included in the analysis=44.|A power model was used to describe functional relationship between dose and Pk parameters. For the evaluation of dose proportionality,slope parameter (B), a two-sided 90% confidence interval of the slope was calculated. Perfect dose proportionality would correspond to a slope of 1.||1.2376|1.0249|
72370381|NCT02093819|144251425|SUPERIORITY_OR_OTHER||Slope|0.9568|STANDARD_ERROR_OF_MEAN|0.1019|||TWO_SIDED|90.0|0.783|1.1307|||||Evaluation of dose proportionality - dose groups 50mg to 600mg. Number of subjects included in the analysis=28.|A power model was used to describe functional relationship between dose and Pk parameters. For the evaluation of dose proportionality,slope parameter (B), a two-sided 90% confidence interval of the slope was calculated. Perfect dose proportionality would correspond to a slope of 1.||1.1307|0.7830|
72370382|NCT02093819|144251426|SUPERIORITY_OR_OTHER||Slope|1.0732|STANDARD_ERROR_OF_MEAN|0.0468|||TWO_SIDED|90.0|0.9946|1.1518|||||Evaluation of dose proportionality - all dose groups. Number of subjects included in the analysis=44.|A power model was used to describe functional relationship between dose and Pk parameters. For the evaluation of dose proportionality,slope parameter (B), a two-sided 90% confidence interval of the slope was calculated. Perfect dose proportionality would correspond to a slope of 1.||1.1518|0.9946|
72451270|NCT04881110|144423413|SUPERIORITY||Mean Difference (Final Values)|-3.4||||0.52|TWO_SIDED|95.0|-14.3|7.4|||t-test, 2 sided||||To evaluate the change of variables over time, we subtracted the values at the start from values at the end. A 2-sample t test was used to compare differences between the interventions. The χ2 test was used for comparing proportions of participants in the 2 groups who reached the primary end point after the intervention. Relative risks (RRs) and 95%Cis were calculated to demonstrate the relationship between the intervention and the achievement of the primary end point. A 2-sided P \< .05 was considered statistically significant.|7.4|-14.3|0.52
72451271|NCT04881110|144423414|SUPERIORITY||Mean Difference (Final Values)|-1.1||||0.33|TWO_SIDED|95.0|-3.6|1.2|||t-test, 2 sided||||To evaluate the change of variables over time, we subtracted the values at the start from values at the end. A 2-sample t test was used to compare differences between the interventions. The χ2 test was used for comparing proportions of participants in the 2 groups who reached the primary end point after the intervention. Relative risks (RRs) and 95%Cis were calculated to demonstrate the relationship between the intervention and the achievement of the primary end point. A 2-sided P \< .05 was considered statistically significant.|1.2|-3.6|0.33
72391323|NCT03000439|144289788|OTHER||Difference in LS Mean|0.47|||||TWO_SIDED|95.0|-1.01|0.9||||||CHAQ-Discomfort Index at Week 12: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||0.90|-1.01|
72391324|NCT03000439|144289788|OTHER||Difference in LS Mean|0.55|||||TWO_SIDED|95.0|-0.49|1.58||||||CHAQ-Discomfort Index at Week 16: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||1.58|-0.49|
72391325|NCT03000439|144289788|OTHER||Difference in LS Mean|0.23|||||TWO_SIDED|95.0|-0.98|1.45||||||CHAQ-Discomfort Index at Week 20: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||1.45|-0.98|
72391326|NCT03000439|144289788|OTHER||Difference in LS Mean|0.32|||||TWO_SIDED|95.0|-0.51|1.14||||||CHAQ-Discomfort Index at Week 24: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||1.14|-0.51|
72391327|NCT03000439|144289788|OTHER||Difference in LS Mean|-0.42|||||TWO_SIDED|95.0|-1.87|1.03||||||CHAQ-Discomfort Index at Week 28: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||1.03|-1.87|
72391328|NCT03000439|144289788|OTHER||Difference in LS Mean|-0.33|||||TWO_SIDED|95.0|-1.53|0.88||||||CHAQ-Discomfort Index at Week 32: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||0.88|-1.53|
72391329|NCT03000439|144289788|OTHER||Difference in LS Mean|-0.31|||||TWO_SIDED|95.0|-1.36|0.74||||||CHAQ-Discomfort Index at Week 36: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||0.74|-1.36|
72391330|NCT03000439|144289788|OTHER||Difference in LS Mean|0.07|||||TWO_SIDED|95.0|-0.55|0.69||||||CHAQ-Discomfort Index at Week 40: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||0.69|-0.55|
72391331|NCT03000439|144289788|OTHER||Difference in LS Mean|-0.31|||||TWO_SIDED|95.0|-1.01|0.39||||||CHAQ-Discomfort Index at Week 44: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||0.39|-1.01|
72451272|NCT04881110|144423415|SUPERIORITY||Mean Difference (Final Values)|-0.7||||0.1|TWO_SIDED|95.0|-1.7|0.1|||t-test, 2 sided||||To evaluate the change of variables over time, we subtracted the values at the start from values at the end. A 2-sample t test was used to compare differences between the interventions. The χ2 test was used for comparing proportions of participants in the 2 groups who reached the primary end point after the intervention. Relative risks (RRs) and 95%Cis were calculated to demonstrate the relationship between the intervention and the achievement of the primary end point. A 2-sided P \< .05 was considered statistically significant.|0.1|-1.7|0.10
72451273|NCT04881110|144423416|SUPERIORITY||Mean Difference (Final Values)|0.36||||0.81|TWO_SIDED|95.0|-2.8|3.5|||t-test, 2 sided||||To evaluate the change of variables over time, we subtracted the values at the start from values at the end. A 2-sample t test was used to compare differences between the interventions. The χ2 test was used for comparing proportions of participants in the 2 groups who reached the primary end point after the intervention. Relative risks (RRs) and 95%Cis were calculated to demonstrate the relationship between the intervention and the achievement of the primary end point. A 2-sided P \< .05 was considered statistically significant.|3.5|-2.8|0.81
72619807|NCT02991859|144770743|OTHER||3 parameter Emax model|14.44|||||TWO_SIDED|95.0|8.21|25.4|||||FP Emax-Maximum Dose response|||25.40|8.21|
72619808|NCT02991859|144770743|OTHER||3 parameter Emax model|1081.27|||||TWO_SIDED|95.0|448.0|2609.66|||||FP ED50-Dose at which 50% of the maximum dose response reached (mcg)|||2609.66|448.00|
72391332|NCT03000439|144289788|OTHER||Difference in LS Mean|0.23|||||TWO_SIDED|95.0|-1.45|1.92||||||CHAQ-Discomfort Index at Week 48: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||1.92|-1.45|
72391333|NCT03000439|144289788|OTHER||Difference in LS Mean|-0.09|||||TWO_SIDED|95.0|-0.87|0.69||||||CHAQ-Discomfort Index at Week 52: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||0.69|-0.87|
72391334|NCT03000439|144289797|OTHER||Difference in percentage|-30.18|||||TWO_SIDED|95.0|-53.43|-6.94|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 4||-6.94|-53.43|
72391335|NCT03000439|144289797|OTHER||Difference in percentage|-23.39|||||TWO_SIDED|95.0|-47.19|0.42|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 8||0.42|-47.19|
72391336|NCT03000439|144289797|OTHER||Difference in percentage|-0.12|||||TWO_SIDED|95.0|-23.99|23.76|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 12||23.76|-23.99|
72451274|NCT04881110|144423417|SUPERIORITY||Mean Difference (Final Values)|-0.003||||0.99|TWO_SIDED|95.0|-5.8|5.8|||t-test, 2 sided||||To evaluate the change of variables over time, we subtracted the values at the start from values at the end. A 2-sample t test was used to compare differences between the interventions. The χ2 test was used for comparing proportions of participants in the 2 groups who reached the primary end point after the intervention. Relative risks (RRs) and 95%Cis were calculated to demonstrate the relationship between the intervention and the achievement of the primary end point. A 2-sided P \< .05 was considered statistically significant.|5.8|-5.8|0.99
72451275|NCT04881110|144423418|SUPERIORITY||Mean Difference (Final Values)|-4.8||||0.72|TWO_SIDED|95.0|-32.6|22.9|||t-test, 2 sided||||To evaluate the change of variables over time, we subtracted the values at the start from values at the end. A 2-sample t test was used to compare differences between the interventions. The χ2 test was used for comparing proportions of participants in the 2 groups who reached the primary end point after the intervention. Relative risks (RRs) and 95%Cis were calculated to demonstrate the relationship between the intervention and the achievement of the primary end point. A 2-sided P \< .05 was considered statistically significant.|22.9|-32.6|0.72
72451276|NCT04881110|144423419|SUPERIORITY||Mean Difference (Final Values)|-0.4||||0.02|TWO_SIDED|95.0|-0.7|-0.07|||t-test, 2 sided||||To evaluate the change of variables over time, we subtracted the values at the start from values at the end. A 2-sample t test was used to compare differences between the interventions. The χ2 test was used for comparing proportions of participants in the 2 groups who reached the primary end point after the intervention. Relative risks (RRs) and 95%Cis were calculated to demonstrate the relationship between the intervention and the achievement of the primary end point. A 2-sided P \< .05 was considered statistically significant.|-0.07|-0.7|0.02
72451277|NCT04881110|144423420|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.12|TWO_SIDED|95.0|-0.04|0.3|||t-test, 2 sided||||To evaluate the change of variables over time, we subtracted the values at the start from values at the end. A 2-sample t test was used to compare differences between the interventions. The χ2 test was used for comparing proportions of participants in the 2 groups who reached the primary end point after the intervention. Relative risks (RRs) and 95%Cis were calculated to demonstrate the relationship between the intervention and the achievement of the primary end point. A 2-sided P \< .05 was considered statistically significant.|0.3|-0.04|0.12
72451278|NCT04881110|144423421|SUPERIORITY||Mean Difference (Final Values)|-3.09||||0.25|TWO_SIDED|95.0|-8.5|2.3|||t-test, 2 sided||||To evaluate the change of variables over time, we subtracted the values at the start from values at the end. A 2-sample t test was used to compare differences between the interventions. The χ2 test was used for comparing proportions of participants in the 2 groups who reached the primary end point after the intervention. Relative risks (RRs) and 95%Cis were calculated to demonstrate the relationship between the intervention and the achievement of the primary end point. A 2-sided P \< .05 was considered statistically significant.|2.3|-8.5|0.25
72451279|NCT04881110|144423422|SUPERIORITY||Mean Difference (Final Values)|87.4|||<|0.001|TWO_SIDED|95.0|59.9|115.1|||t-test, 2 sided||||To evaluate the change of variables over time, we subtracted the values at the start from values at the end. A 2-sample t test was used to compare differences between the interventions. The χ2 test was used for comparing proportions of participants in the 2 groups who reached the primary end point after the intervention. Relative risks (RRs) and 95%Cis were calculated to demonstrate the relationship between the intervention and the achievement of the primary end point. A 2-sided P \< .05 was considered statistically significant.|115.1|59.9|<0.001
72451280|NCT04881110|144423423|SUPERIORITY||Mean Difference (Final Values)|-0.03||||0.18|TWO_SIDED|95.0|-0.09|0.01|||t-test, 2 sided||||To evaluate the change of variables over time, we subtracted the values at the start from values at the end. A 2-sample t test was used to compare differences between the interventions. The χ2 test was used for comparing proportions of participants in the 2 groups who reached the primary end point after the intervention. Relative risks (RRs) and 95%Cis were calculated to demonstrate the relationship between the intervention and the achievement of the primary end point. A 2-sided P \< .05 was considered statistically significant.|0.01|-0.09|0.18
72451281|NCT04881110|144423424|SUPERIORITY||Mean Difference (Final Values)|8.7||||0.06|TWO_SIDED|95.0|-0.6|18.1|||t-test, 2 sided||||To evaluate the change of variables over time, we subtracted the values at the start from values at the end. A 2-sample t test was used to compare differences between the interventions. The χ2 test was used for comparing proportions of participants in the 2 groups who reached the primary end point after the intervention. Relative risks (RRs) and 95%Cis were calculated to demonstrate the relationship between the intervention and the achievement of the primary end point. A 2-sided P \< .05 was considered statistically significant.|18.1|-0.6|0.06
72451282|NCT04881110|144423425|SUPERIORITY||Mean Difference (Final Values)|1.2||||0.06|TWO_SIDED|95.0|-0.09|2.6|||t-test, 2 sided||||To evaluate the change of variables over time, we subtracted the values at the start from values at the end. A 2-sample t test was used to compare differences between the interventions. The χ2 test was used for comparing proportions of participants in the 2 groups who reached the primary end point after the intervention. Relative risks (RRs) and 95%Cis were calculated to demonstrate the relationship between the intervention and the achievement of the primary end point. A 2-sided P \< .05 was considered statistically significant.|2.6|-0.09|0.06
72451283|NCT04881110|144423427|SUPERIORITY||Mean Difference (Final Values)|25.1|||<|0.001|TWO_SIDED|95.0|21.8|28.3|||t-test, 2 sided||||To evaluate the change of variables over time, we subtracted the values at the start from values at the end. A 2-sample t test was used to compare differences between the interventions. The χ2 test was used for comparing proportions of participants in the 2 groups who reached the primary end point after the intervention. Relative risks (RRs) and 95%Cis were calculated to demonstrate the relationship between the intervention and the achievement of the primary end point. A 2-sided P \< .05 was considered statistically significant.|28.3|21.8|<0.001
72451284|NCT02933489|144423460|EQUIVALENCE|H0: DBT = AB-MR|Wald interval with Bonett-Price Laplace|0.007||||0.002|TWO_SIDED|95.0|0.0022|0.0116|||McNemar||"Wald interval with Bonett-Price Laplace, described in :~Fagerland MW, Lydersen S, Laake P. Recommended tests and confidence intervals for paired binomial proportions. Statist. Med. 2014; 33:2850-75."|The proportion of participants who had an invasive cancer, verified by pathology, detected by each modality (the invasive cancer detection rates) will be made using exact McNemar's test.||0.0116|0.0022|0.002
72619809|NCT02991859|144770743|OTHER||3 parameter Emax model|13.5|||||TWO_SIDED|95.0|9.39|19.39|||||BUD E0-Response of Placebo participants|||19.39|9.39|
72619810|NCT02991859|144770743|OTHER||3 parameter Emax model|14.44|||||TWO_SIDED|95.0|8.21|25.4|||||BUD Emax-Maximum Dose response|||25.40|8.21|
72451285|NCT02933489|144423461|EQUIVALENCE|PPV DBT = PPV AB-MR||||||0.15||||||"Generalized estimating equation (GEE) regression with the p-value from the resulting score test.~5 secondary comparisons were planned: alpha level of 0.05/5 = 0.01 for p-value significance"|Leisenring|Leisenring W, Alonzo T, Pepe MS. Comparisons of predictive values of binary medical diagnostic tests for paired designs. Biometrics. 2000;56:345-351||Positive Predictive Value (PPV)||||0.15
72451286|NCT02933489|144423462|EQUIVALENCE|H0: DBT short term follow-up rate = AB-MR short term follow-up rate|||||<|0.0001||||||To adjust for multiplicity, using the Bonferroni correction, secondary comparisons are compared against an adjusted alpha level of 0.05/5=0.01 corresponding to the 5 secondary comparisons outlined in the Statistical Analysis Plan (SAP)|McNemar|exact p-value||The exact p-value from McNemar's test is reported for for comparing the DBT against the AB-MR short term follow-up rates||||<0.0001
72451287|NCT02933489|144423462|EQUIVALENCE|H0: DBT additional imaging rate =AB-MR additional imaging rate||||||0.02||||||To adjust for multiplicity, using the Bonferroni correction, secondary comparisons are compared against an adjusted alpha level of 0.05/5 = 0.01, corresponding to the 5 secondary comparisons outlined in the SAP|McNemar|exact p-values||The exact p-value from McNemar's test is reported for for comparing the DBT against the AB-MR additional imaging rates||||0.02
72451288|NCT02933489|144423463|EQUIVALENCE|Sensitivity DBT = Sensitivity AB-MR||||||0.001||||||The comparison of the sensitivity of AB-MR and DBT uses a two-sided exact McNemar's test to account for the paired design 5 secondary comparisons were planned: alpha level of 0.05/5 = 0.01 for p-value significance|McNemar|||||||0.001
72451289|NCT02933489|144423463|EQUIVALENCE|Specificity DBT = Specificity AB-MR|||||<|0.001||||||The comparison of the Specificity of AB-MR and DBT uses a two-sided exact McNemar's test to account for the paired design 5 secondary comparisons were planned: alpha level of 0.05/5 = 0.01 for p-value significance|McNemar|||||||<0.001
72451290|NCT02994927|144423473|NON_INFERIORITY|The proportion of subjects achieving disease remission at Week 26 and the two-sided 95% confidence intervals (CIs) for the difference in proportions was estimated for the comparison between the avacopan group and the prednisone group. For both the noninferiority and superiority tests, the one-sided P-values are presented. Statistical significance was claimed based on the one-sided type-I error of 0.025.|Common difference in remission rates|3.4|||<|0.0001|TWO_SIDED|95.0|-6.0|12.8|||Summary score test||Summary Score estimate of the common difference and Miettinen-Nurminen (score) confidence limits for the common difference|||12.8|-6.0|< 0.0001
72391337|NCT03000439|144289797|OTHER||Difference in percentage|6.68|||||TWO_SIDED|95.0|-17.2|30.56|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 16||30.56|-17.20|
72451291|NCT02994927|144423473|SUPERIORITY|The proportion of subjects achieving disease remission at Week 26 and the two-sided 95% confidence intervals (CIs) for the difference in proportions was estimated for the comparison between the avacopan group and the prednisone group. For both the noninferiority and superiority tests, the one-sided P-values are presented. Statistical significance was claimed based on the one-sided type-I error of 0.025.|Common difference in remission rates|3.4|||=|0.2387|TWO_SIDED|95.0|-6.0|12.8|||Summary score test||Summary Score estimate of the common difference and Miettinen-Nurminen (score) confidence limits for the common difference|||12.8|-6.0|= 0.2387
72451292|NCT02994927|144423474|NON_INFERIORITY|The proportion of subjects achieving sustained disease remission at Week 52, and the two-sided 95% confidence intervals (CIs) for the difference in proportions (avacopan minus prednisone) was estimated for the comparison between the avacopan group and the prednisone group. For both the noninferiority and superiority tests, the one-sided P-values are presented. Statistical significance was claimed based on the one-sided type-I error of 0.025.|Common difference in remission rates|12.5|||<|0.0001|TWO_SIDED|95.0|2.6|22.3|||Summary score test||Summary Score estimate of the common difference and Miettinen-Nurminen (score) confidence limits for the common difference|||22.3|2.6|< 0.0001
72451293|NCT02994927|144423474|SUPERIORITY|The proportion of subjects achieving sustained disease remission at Week 52, and the two-sided 95% confidence intervals (CIs) for the difference in proportions (avacopan minus prednisone) was estimated for the comparison between the avacopan group and the prednisone group. For both the noninferiority and superiority tests, the one-sided P-values are presented. Statistical significance was claimed based on the one-sided type-I error of 0.025.|Common difference in remission rates|12.5|||=|0.0066|TWO_SIDED|95.0|2.6|22.3|||Summary score test||Summary Score estimate of the common difference and Miettinen-Nurminen (score) confidence limits for the common difference|||22.3|2.6|= 0.0066
72451294|NCT03982186|144423531|SUPERIORITY||Difference of proportions|-2.3|||=|0.848|TWO_SIDED|90.0|-5.97|1.38|||Mantel Haenszel|||||1.38|-5.97|= 0.848
72451295|NCT03982186|144423531|SUPERIORITY||Difference of proportions|7.4|||=|0.027|TWO_SIDED|90.0|1.07|13.68|||Mantel Haenszel|||||13.68|1.07|= 0.027
72451296|NCT03982186|144423531|SUPERIORITY||Difference of proportions|9.1|||=|0.917|TWO_SIDED|90.0|4.16|14.07|||Mantel Haenszel|||||14.07|4.16|= 0.917
72451297|NCT03982186|144423531|SUPERIORITY||Difference of proportions|-6.7|||=|0.917|TWO_SIDED|90.0|-14.67|1.25|||Mantel Haenszel|||||1.25|-14.67|= 0.917
72451298|NCT01880515|144423595|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.4|||||TWO_SIDED|95.0|0.17|0.99||||||||0.99|0.17|
72451299|NCT01880515|144423598|SUPERIORITY|||||||0.41|||||||Log Rank|||||||0.41
72451300|NCT04734197|144423599|SUPERIORITY|||||||0.004||||||The threshold for statistical significance is p=0.05.|Fisher Exact|||Exploratory Phase 2 Study; the sample size of approximately 280-350 subjects (between 40 and 50 subjects per each of the 7 treatment groups) was based on medical judgement.||||0.0040
72451301|NCT04734197|144423600|SUPERIORITY|||||||0.3111|||||||Fisher Exact|The threshold for statistical significance is p=0.05.||"Mixed Model for Repeated Measures (MMRM) analysis included fixed effects of baseline TBUT, age, treatment, visit, and treatment by visit interaction.~Least squares means (LSMs) of the absolute TBUT change from baseline and their 95% CIs were estimated from the MMRM model for each treatment group."||||0.3111
72451302|NCT04734197|144423601|SUPERIORITY|||||||0.2027||||||The threshold for statistical significance is p=0.05.|Fisher Exact|||"MMRM analysis included fixed effects of baseline Schirmer test score, age, treatment, visit, and treatment by visit interaction.~LSMs of the absolute change from baseline in Schirmer test score and their 95% CIs were estimated from the MMRM model for each treatment group."||||0.2027
72451303|NCT04310423|144423602|OTHER|||||||0.036|||||||Mixed Models Analysis|||Treatment x Time interaction for alcohol cue-induced alcohol craving.||||0.036
72451304|NCT04310423|144423603|OTHER||||||>|0.05|||||||Mixed Models Analysis|||Two-way Treatment x Time interaction||||>0.05
72451305|NCT04310423|144423604|OTHER||||||>|0.05|||||||Mixed Models Analysis|||Treatment x Time interactions||||>0.05
72451306|NCT04310423|144423605|OTHER||||||>|0.05|||||||Mixed Models Analysis|||Treatment x Time interactions||||>0.05
72451307|NCT04310423|144423606|OTHER||||||<|0.001|||||||ANCOVA|||Main effect of treatment on alcohol cue-elicited brain activation||||<0.001
72451308|NCT02777593|144423663|OTHER|Performance goal tested using Exact method calculation to estimate the 95% one-sided lower confidence level (95% LCL) on the proportion of participants with primary endpoint success. If the 95% LCL exceeded 0.64, then the the null hypothesis was to be rejected and the PG was met.|95% Exact Lower Confidence Limit|0.751|||||ONE_SIDED|||||||||"Primary endpoint success was defined as the proportion of analysis-eligible participants without a primary endpoint event and with 12-Month imaging performed.~Results were tested against a performance goal (PG) of 0.64 (i.e. 64%), derived from historical GORE TAG® and Conformable TAG® data.~Additionally, using a one-sided alpha of 0.05 and Exact Test, minimum power of 80%, the sample needed was 70 patients. With attrition, 85 patients were required."||||
72451309|NCT05785130|144423665|SUPERIORITY|T0|Mean Difference (Final Values)|-25.07||||0.74|TWO_SIDED|||||T0|t-test, 2 sided|||It was calculated that 58 participants were randomized in a 1:1 between two arms on baseline, the first intervention day(T1), the third intervention day(T2), and follow up two days later after intervention (T3) . Sample size was determoned using G-power repeated measures, between factors(α = 0.05, power = 0.8). Assumption a discontinution rate of 10%.||||0.74
72451310|NCT05785130|144423665|SUPERIORITY||Median Difference (Final Values)|133.57||||0.75|TWO_SIDED|||||T1|t-test, 2 sided|||It was calculated that 58 participants were randomized in a 1:1 between two arms on baseline, the first intervention day(T1), the third intervention day(T2), and follow up two days later after intervention (T3) . Sample size was determoned using G-power repeated measures, between factors(α = 0.05, power = 0.8). Assumption a discontinution rate of 10%.||||0.75
72451311|NCT05785130|144423665|SUPERIORITY|T|Median Difference (Final Values)|235.93|||<|0.01|TWO_SIDED|||||T2|t-test, 2 sided|||It was calculated that 58 participants were randomized in a 1:1 between two arms on baseline, the first intervention day(T1), the third intervention day(T2), and follow up two days later after intervention (T3) . Sample size was determoned using G-power repeated measures, between factors(α = 0.05, power = 0.8). Assumption a discontinution rate of 10%.||||<0.01
72451312|NCT05785130|144423665|SUPERIORITY|T3|Median Difference (Final Values)|214.18|||<|0.01|TWO_SIDED|||||T3|t-test, 2 sided|||It was calculated that 58 participants were randomized in a 1:1 between two arms on baseline, the first intervention day(T1), the third intervention day(T2), and follow up two days later after intervention (T3) . Sample size was determoned using G-power repeated measures, between factors(α = 0.05, power = 0.8). Assumption a discontinution rate of 10%.||||<0.01
72451313|NCT03351998|144423666|SUPERIORITY||Mean Difference (Net)|36.02|STANDARD_DEVIATION|365.55||0.6051|TWO_SIDED||||||signed rank test|This is within group 12 month change.||||||0.6051
72451314|NCT03351998|144423666|SUPERIORITY||Mean Difference (Net)|31.89|STANDARD_DEVIATION|213.0||0.9434|TWO_SIDED||||||signed rank test|This is within group 12 month change.||||||0.9434
72451315|NCT03351998|144423666|SUPERIORITY||Mean Difference (Net)|-3.39|STANDARD_DEVIATION|179.54||0.9408|TWO_SIDED||||||t-test, 2 sided|This is within group 12 month change.||||||0.9408
72451316|NCT03351998|144423667|SUPERIORITY||Mean Difference (Net)|-0.2|STANDARD_DEVIATION|0.23||0.7458|TWO_SIDED||||||t-test, 2 sided|This is within group 12 month change.||||||0.7458
72451317|NCT03351998|144423667|SUPERIORITY||Mean Difference (Net)|0.03|STANDARD_DEVIATION|0.16||0.4056|TWO_SIDED||||||t-test, 2 sided|This is within group 12 month change.||||||0.4056
72451318|NCT03351998|144423667|SUPERIORITY||Mean Difference (Net)|-0.06|STANDARD_DEVIATION|0.18||0.1932|TWO_SIDED||||||t-test, 2 sided|This is within group 12 month change.||||||0.1932
72451319|NCT04093869|144423715|SUPERIORITY||Mean Difference (Net)|4.1|STANDARD_ERROR_OF_MEAN|5.1||0.4|TWO_SIDED|95.0|-6.0|14.0||Not adjusted for multiple comparisons. Full alpha of 0.05 was allocated to this as the sole primary outcome.|Regression, Linear||A negative mean difference would represent a better outcome in the CSTEX arm compared to the SOC-ED arm.|||14|-6|0.40
72451320|NCT04093869|144423716|SUPERIORITY||Mean Difference (Net)|20.7|STANDARD_ERROR_OF_MEAN|32.6|||TWO_SIDED|95.0|-44.0|85.0|||||A positive value for the estimate represents a greater distance walked for the CSTEX arm compared to the SOC-ED arm.|||85|-44|
72451321|NCT04093869|144423717|SUPERIORITY||Median Difference (Net)|-316.0|STANDARD_ERROR_OF_MEAN|336.0|||TWO_SIDED|95.0|-979.0|346.0|||||A positive value for the estimate would represent more steps per day for the CSTEX arm compared to the SOC-ED arm.|||346|-979|
72451322|NCT04093869|144423718|SUPERIORITY||Mean Difference (Net)|14.7|STANDARD_ERROR_OF_MEAN|10.0|||TWO_SIDED|95.0|-5.0|34.0||||||||34|-5|
72504804|NCT03114969|144540515|SUPERIORITY||Odds Ratio (OR)|5.132||||0.046|TWO_SIDED|95.0|1.031|25.55||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta+\[Relvar Ellipta+LAMA\] as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.|||25.550|1.031|0.046
72451323|NCT04093869|144423719|SUPERIORITY||Mean Difference (Net)|0.0034|STANDARD_ERROR_OF_MEAN|0.055|||TWO_SIDED|95.0|-0.1|0.11|||||A negative value for the estimate would represent a better QOL survey score for the CSTEX arm compared to the SOC-ED arm.|||0.11|-0.1|
72451324|NCT04093869|144423720|SUPERIORITY||Mean Difference (Net)|0.041|STANDARD_ERROR_OF_MEAN|0.13|||TWO_SIDED|95.0|-0.22|0.3|||||A negative value for the estimate would represent a better Frailty index score for the CSTEX arm compared to the SOC-ED arm.|||0.30|-0.22|
72451325|NCT04093869|144423721|SUPERIORITY||Mean Difference (Net)|-0.02|STANDARD_ERROR_OF_MEAN|0.09|||TWO_SIDED|95.0|-0.2|0.17||||||||0.17|-0.20|
72451326|NCT04093869|144423722|SUPERIORITY||Mean Difference (Net)|-0.01|STANDARD_ERROR_OF_MEAN|0.06|||TWO_SIDED|95.0|-0.13|0.1||||||||0.10|-0.13|
72451327|NCT04093869|144423723|SUPERIORITY||Mean Difference (Net)|-0.02|STANDARD_ERROR_OF_MEAN|0.05|||TWO_SIDED|95.0|-0.12|0.07||||||||0.07|-0.12|
72451328|NCT04093869|144423724|SUPERIORITY||Mean Difference (Net)|0.39|STANDARD_ERROR_OF_MEAN|0.62|||TWO_SIDED|95.0|-0.83|1.6|||||A positive value for the estimate represents better self-efficacy for the CSTEX arm compared to the SOC-ED arm.|||1.60|-0.83|
72451329|NCT04243759|144423752|SUPERIORITY|||||||0.97|||||||ANOVA|||||||0.97
72451330|NCT04243759|144423753|SUPERIORITY||Mean Difference (Final Values)|0.36|STANDARD_DEVIATION|2.09||0.232|TWO_SIDED|95.0|-0.24|0.95|||t-test, 2 sided|||Within subjects comparison of drinks per drinking day with full intervention app access versus daily assessment via the app only||0.95|-0.24|.232
72451331|NCT03816397|144423755|SUPERIORITY|A sample size of 118 subjects (59 in each group) provides 88% power to detect a hazard ratio of 2.0 for the time to treatment failure comparing the group randomized to discontinue adalimumab to the group randomized to continue using adalimumab, assuming a median time until treatment failure of 10 weeks in the group that discontinues adalimumab (Arm 1) and of 20 weeks in the group that continues on adalimumab (Arm 2), an equal allocation between groups, and a 10% total loss to follow-up.|Hazard Ratio (HR)|8.7|||<|0.0001|TWO_SIDED|95.0|3.6|21.2||A priori threshold for statistical significance was \<0.05.|Log Rank||For the HR, the numerator is the placebo group (stop adalimumab) and the denominator is the adalimumab group (continue adalimumab).|A Cox proportional hazards regression was used to compare time to treatment failure between the adalimumab and placebo groups up to the primary endpoint of 48 weeks, with country and conventional DMARD use included as fixed effects in the model. The null hypothesis was an hazard ratio (HR) of 1. Hypothesis testing was based on a permutation test of the log hazard ratio (100,000 replicates). The model was checked for the assumption of proportional hazards by assessing Schoenfeld residuals.||21.2|3.6|<0.0001
72451332|NCT03493542|144423759|NON_INFERIORITY|The statistical criterion for non-inferiority required that the lower bound of two-sided 95% confidence interval of GMT ratio (9 to 19 years old/20 to 26 years old) was greater than 0.67 for each HPV type.|GMT Ratio|1.42|||<|0.0001|TWO_SIDED|95.0|1.28|1.58|||ANOVA||GMT Ratio = GMT (9-19 yr)/GMT(20-26 yr)|Anti-HPV 6||1.58|1.28|<0.0001
72451333|NCT03493542|144423759|NON_INFERIORITY|The statistical criterion for non-inferiority required that the lower bound of two-sided 95% confidence interval of GMT ratio (9 to 19 years old/20 to 26 years old) was greater than 0.67 for each HPV type.|GMT Ratio|1.39|||<|0.0001|TWO_SIDED|95.0|1.25|1.55|||ANOVA||GMT Ratio = GMT (9-19 yr)/GMT(20-26 yr)|Anti-HPV 11||1.55|1.25|<0.0001
72451334|NCT03493542|144423759|NON_INFERIORITY|The statistical criterion for non-inferiority required that the lower bound of two-sided 95% confidence interval of GMT ratio (9 to 19 years old/20 to 26 years old) was greater than 0.67 for each HPV type.|GMT Ratio|1.53|||<|0.0001|TWO_SIDED|95.0|1.37|1.7|||ANOVA||GMT Ratio = GMT (9-19 yr)/GMT(20-26 yr)|Anti-HPV 16||1.70|1.37|<0.0001
72451335|NCT03493542|144423759|NON_INFERIORITY|The statistical criterion for non-inferiority required that the lower bound of two-sided 95% confidence interval of GMT ratio (9 to 19 years old/20 to 26 years old) was greater than 0.67 for each HPV type.|GMT Ratio|1.66|||<|0.0001|TWO_SIDED|95.0|1.45|1.9|||ANOVA||GMT Ratio = GMT (9-19 yr)/GMT(20-26 yr)|Anti-HPV 18||1.90|1.45|<0.0001
72451336|NCT03493542|144423780|NON_INFERIORITY|The statistical criterion for non-inferiority required that the lower bound of two-sided 95% confidence interval for the difference (9 to 19 years old minus 20 to 26 years old) in seroconversion percentages being greater than -5 percentage points for each HPV type.|Difference in percentages (%)|0.0|||<|0.0001|TWO_SIDED|95.0|-1.1|1.2|||Miettinen & Nurminen method|||Difference of Seroconversion percentage HPV 6||1.2|-1.1|<0.0001
72561971|NCT03653026|144654944|SUPERIORITY||Adjusted Response Rate Difference|35.1|||<|0.001|TWO_SIDED|95.0|28.6|41.6||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Cochran-Mantel-Haenszel|Adjusted for Baseline corticosteroid use (yes or no), Baseline Adapted Mayo score (≤ 7 or \> 7), and bio-IR status (bio-IR or non-bio-IR).|Difference = Upadacitinib 45 mg - Placebo|||41.6|28.6|<0.001
72451337|NCT03493542|144423780|NON_INFERIORITY|The statistical criterion for non-inferiority required that the lower bound of two-sided 95% confidence interval for the difference (9 to 19 years old minus 20 to 26 years old) in seroconversion percentages being greater than -5 percentage points for each HPV type.|Difference in percentages (%)|0.0|||<|0.0001|TWO_SIDED|95.0|-1.1|1.2|||Miettinen & Nurminen method|||Difference of Seroconversion percentage HPV 11||1.2|-1.1|<0.0001
72451338|NCT03493542|144423780|NON_INFERIORITY|The statistical criterion for non-inferiority required that the lower bound of two-sided 95% confidence interval for the difference (9 to 19 years old minus 20 to 26 years old) in seroconversion percentages being greater than -5 percentage points for each HPV type.|Difference in percentages (%)|0.0|||<|0.0001|TWO_SIDED|95.0|-1.1|1.2|||Miettinen & Nurminen method|||Difference of Seroconversion percentage HPV 16||1.2|-1.1|<0.0001
72451339|NCT03493542|144423780|NON_INFERIORITY|The statistical criterion for non-inferiority required that the lower bound of two-sided 95% confidence interval for the difference (9 to 19 years old minus 20 to 26 years old) in seroconversion percentages being greater than -5 percentage points for each HPV type.|Difference in percentages (%)|0.0|||<|0.0001|TWO_SIDED|95.0|-1.1|1.2|||Miettinen & Nurminen method|||Difference of Seroconversion percentage HPV 18||1.2|-1.1|<0.0001
72451340|NCT05485935|144423789|SUPERIORITY||Mean Difference (Final Values)|45.94||||0.001|TWO_SIDED|95.0|19.24|72.64||The pass criteria were based on results analysing the 2 primary endpoints in a hierarchical fashion: rejecting the H0 on the first endpoint (Residual urine at first flow-stop) before continuing to the second (Number of flow-stop episodes).|Mixed Models Analysis|||This was a superiority investigation in which the null hypothesis of the primary endpoints was to be rejected, at a 5% significance (alpha 0.05), to demonstrate the superiority of the investigational device.||72.64|19.24|0.001
72619811|NCT02991859|144770743|OTHER||3 parameter Emax model|1467.36|||||TWO_SIDED|95.0|546.51|3939.84|||||BUD ED50-Dose at which 50% of the maximum dose response reached (mcg)|||3939.84|546.51|
72619812|NCT02991859|144770744|OTHER||Exponential power-law model|176.09|||||TWO_SIDED|95.0|162.87|190.38|||||FF E0-Response of Placebo participants|||190.38|162.87|
72619813|NCT02991859|144770744|OTHER||exponential power-law model|899.99|||||TWO_SIDED|95.0|698.36|1101.62|||||FF ED50 Dose at which 50% of the maximum dose response reached|||1101.62|698.36|
72619814|NCT02991859|144770744|OTHER||exponential power-law model|176.09|||||TWO_SIDED|95.0|162.87|190.38|||||FP E0-Response of Placebo participants|||190.38|162.87|
72451341|NCT05485935|144423790|SUPERIORITY|The pass criteria were based on the results analysing the two primary endpoints in a hierarchical fashion: rejecting the null hypothesis on the first endpoint (Residual urine at first flow-stop) before continuing to the second (Number of flow-stop episodes).|Risk Ratio (RR)|0.15|||<|0.001|TWO_SIDED|95.0|0.07|0.35|||Mixed Models Analysis|||This was a superiority investigation in which the null hypothesis of the primary endpoints was to be rejected, at a 5% significance (alpha 0.05), to demonstrate the superiority of the investigational device.||0.35|0.07|<0.001
72451342|NCT05485935|144423791|SUPERIORITY|The pass criteria were based on the results analysing the two primary endpoints in a hierarchical fashion: rejecting the null hypothesis on the first endpoint (Residual urine at first flow-stop) before continuing to the second (Number of flow-stop episodes).|Risk Ratio (RR)|0.13|||<|0.001|TWO_SIDED|95.0|0.04|0.4|||Mixed Models Analysis|||This was a superiority investigation in which the null hypothesis of the primary endpoints was to be rejected, at a 5% significance (alpha 0.05), to demonstrate the superiority of the investigational device.||0.40|0.04|<0.001
72561972|NCT03653026|144654945|SUPERIORITY||Adjusted Response Rate Difference|15.9|||<|0.001|TWO_SIDED|95.0|11.4|20.3||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Cochran-Mantel-Haenszel|Adjusted for Baseline corticosteroid use (yes or no), Baseline Adapted Mayo score (≤ 7 or \> 7), and bio-IR status (bio-IR or non-bio-IR).|Difference = Upadacitinib 45 mg - Placebo|||20.3|11.4|<0.001
72451343|NCT05485935|144423792|SUPERIORITY|The pass criteria were based on the results analysing the two primary endpoints in a hierarchical fashion: rejecting the null hypothesis on the first endpoint (Residual urine at first flow-stop) before continuing to the second (Number of flow-stop episodes).|Mean Difference (Final Values)|28.5||||0.004|TWO_SIDED|95.0|9.5|47.6|||Mixed Models Analysis|||This was a superiority investigation in which the null hypothesis of the primary endpoints was to be rejected, at a 5% significance (alpha 0.05), to demonstrate the superiority of the investigational device.||47.6|9.5|0.004
72451344|NCT03952520|144423849|SUPERIORITY||Mean Difference (Final Values)|37.3|||||TWO_SIDED|95.0|26.5|48.1|||||This generalized linear model was adjusted for engagement of site leadership. The Standard Approach is the referent.|||48.1|26.5|
72451345|NCT03952520|144423850|SUPERIORITY||Risk Difference (RD)|2.0|||||TWO_SIDED|95.0|2.0|2.1|||||This generalized linear model was adjusted for engagement of site leadership and used generalized estimating equations to account for clustering by HIV test site. The Standard Approach is the referent.|||2.1|2.0|
72451346|NCT03952520|144423852|SUPERIORITY||Mean Difference (Final Values)|0.1|||||TWO_SIDED|95.0|-0.2|0.4|||||This generalized linear model was adjusted for engagement of site leadership and used generalized estimating equations to account for clustering by HIV test site. The Standard Approach is the referent.|||0.4|-0.2|
72451347|NCT03952520|144423853|SUPERIORITY||Mean Difference (Final Values)|-0.6|||||TWO_SIDED|95.0|-3.1|2.0|||||This generalized linear model was adjusted for engagement of site leadership and used generalized estimating equations to account for clustering by HIV test site. The Standard Approach is the referent.|||2.0|-3.1|
72451348|NCT03952520|144423854|SUPERIORITY||Prevalence Difference|15.8|||||TWO_SIDED|95.0|5.0|26.5|||||This generalized linear model was adjusted for engagement of site leadership and used generalized estimating equations to account for clustering by HIV test site. The Standard Approach is the referent.|||26.5|5.0|
72451349|NCT03952520|144423855|SUPERIORITY||Prevalence Difference|1.6|||||TWO_SIDED|95.0|-6.9|10.0|||||This generalized linear model was adjusted for engagement of site leadership and used generalized estimating equations to account for clustering by HIV test site. The Standard Approach is the referent.|||10.0|-6.9|
72451350|NCT03952520|144423857|SUPERIORITY||Prevalence Difference|6.2|||||TWO_SIDED|95.0|-1.5|13.8|||||This generalized linear model was adjusted for engagement of site leadership and used generalized estimating equations to account for clustering by HIV test site. The Standard Approach is the referent.|||13.8|-1.5|
72451351|NCT03635567|144423859|OTHER||Hazard Ratio (HR)|0.58|||<|0.0001|TWO_SIDED|95.0|0.47|0.71||No formal hypothesis testing performed; nominal p-value provided for treatment comparison.|Stratified Log-Rank|Nominal p-value based on log-rank test stratified by metastatic at initial diagnosis (FIGO \[2009\] stage IVB), bevacizumab use, and PD-L1 status.||Treatment comparison (hazard ratio \[HR\]) was based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by metastatic at initial diagnosis (FIGO \[2009\] stage IVB) (yes or no), bevacizumab use (yes or no), and PD-L1 status (CPS\<1, CPS 1 to \<10, or CPS ≥10).||0.71|0.47|<0.0001
72561973|NCT03653026|144654946|SUPERIORITY||Adjusted Response Rate Difference|49.4|||<|0.001|TWO_SIDED|95.0|41.7|57.1||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Cochran-Mantel-Haenszel|Adjusted for Baseline corticosteroid use (yes or no), Baseline Adapted Mayo score (≤ 7 or \> 7), and bio-IR status (bio-IR or non-bio-IR).|Difference = Upadacitinib 45 mg - Placebo|||57.1|41.7|<0.001
72561974|NCT03653026|144654947|SUPERIORITY||Adjusted Response Rate Difference|37.0|||<|0.001|TWO_SIDED|95.0|28.8|45.1||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Cochran-Mantel-Haenszel|Adjusted for Baseline corticosteroid use (yes or no), Baseline Adapted Mayo score (≤ 7 or \> 7), and bio-IR status (bio-IR or non-bio-IR).|Difference = Upadacitinib 45 mg - Placebo|||45.1|28.8|<0.001
72561975|NCT03653026|144654948|SUPERIORITY||Adjusted Response Rate Difference|30.1|||<|0.001|TWO_SIDED|95.0|24.1|36.2||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Cochran-Mantel-Haenszel|Adjusted for Baseline corticosteroid use (yes or no), Baseline Adapted Mayo score (≤ 7 or \> 7), and bio-IR status (bio-IR or non-bio-IR).|Difference = Upadacitinib 45 mg - placebo|||36.2|24.1|<0.001
72451352|NCT03635567|144423860|OTHER||Hazard Ratio (HR)|0.61|||<|0.0001|TWO_SIDED|95.0|0.5|0.74||No formal hypothesis testing performed; nominal p-value provided for treatment comparison.|Stratified Log-Rank|Nominal p-value based on log-rank test stratified by metastatic at initial diagnosis (FIGO \[2009\] stage IVB), bevacizumab use, and PD-L1 status.||Treatment comparison (HR) was based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by metastatic at initial diagnosis (FIGO \[2009\] stage IVB) (yes or no), bevacizumab use (yes or no), and PD-L1 status (CPS\<1, CPS 1 to \<10, or CPS ≥10).||0.74|0.50|<0.0001
72451353|NCT03635567|144423861|OTHER||Hazard Ratio (HR)|0.52|||<|0.0001|TWO_SIDED|95.0|0.4|0.68||No formal hypothesis testing performed; nominal p-value provided for treatment comparison.|Stratified Log-Rank|Nominal p-value based on log-rank test stratified by metastatic at initial diagnosis (FIGO \[2009\] stage IVB), bevacizumab use, and PD-L1 status.||Treatment comparison (HR) was based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by metastatic at initial diagnosis (FIGO \[2009\] stage IVB) (yes or no), bevacizumab use (yes or no), and PD-L1 status (CPS\<1, CPS 1 to \<10, or CPS ≥10).||0.68|0.40|<0.0001
72499032|NCT01656772|144528241|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin d = -0.05. The null hypothesis was to be rejected if Z \> 1.645 or, equivalently, if the corresponding p-value was less than 0.05.||||||0.0405|TWO_SIDED|||||Adjusted to take into account the correlation between multiple PVs on the same subject. The sample estimate of the intraclass correlation coefficient was calculated as the Pearson sample correlation coefficient for all pairs of observations.|Farrington and Manning|||The primary effectiveness endpoint is the successful navigation and EGM recording of each pre-specified pulmonary vein (PV). The RF ablation treatment was not part of the investigational procedure. The null hypothesis was to be tested at the α = 0.05 significance level using a test statistic Z based on the Farrington and Manning likelihood score statistic with adjustment to take into account the correlation between multiple observations (PVs) on the same subject.||||0.0405
72499033|NCT01656772|144528242|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin d= 0.07. The one-sided null hypothesis was to be tested at the α = 0.05 significance level using a standard unpooled asymptotically normal test statistic. The null hypothesis was to be rejected if Z \< -1.7046 or, equivalently, if the corresponding p-value was less than 0.05.||||||0.0441|TWO_SIDED||||||Z-statistic|||||||.0441
72499034|NCT01651780|144528243|NON_INFERIORITY_OR_EQUIVALENCE|If non-inferiority was confirmed, then superiority analysis was pursued.|Relative Risk|0.77||||0.2692|TWO_SIDED|95.0|0.48|1.23|||Chi-squared|||||1.23|0.48|0.2692
72499035|NCT01651780|144528244|NON_INFERIORITY_OR_EQUIVALENCE|If non-inferiority was confirmed, then superiority analysis was pursued.|Relative Risk|0.89||||0.4967|TWO_SIDED|95.0|0.64|1.24|||Chi-squared|||||1.24|0.64|0.4967
72499036|NCT03359902|144528264|SUPERIORITY||beta|1.4||||0.11|TWO_SIDED||||||Mixed Models Analysis|||"A linear mixed effects model was conducted to account for carryover and order effects in this crossover trial.~Assuming α = 0.05, two-sided test, and 60 participants in total. If the carryover effect is negligible, we will have 90% power to detect an effect size of 0.604 for memory improvement"||||0.11
72499037|NCT02930174|144528267|EQUIVALENCE|Two devices were tested while measuring the differences in lung impedance under multiple pressure settings to determine whether the devices perform in an equivalent fashion. We looked at the mean differences between the 2 devices across the 4 pressure settings.|Mean Difference (Final Values)|0.1|STANDARD_DEVIATION|2.0||0.26|TWO_SIDED||||||ANOVA|||||||0.26
72499038|NCT02930174|144528268|EQUIVALENCE|Two devices were tested while measuring the differences in lung impedance under multiple pressure settings to determine whether the devices perform in an equivalent fashion. We looked at the mean differences between the 2 devices across the 4 pressure settings.|Mean Difference (Final Values)|0.1|STANDARD_DEVIATION|2.0||0.342|TWO_SIDED||||||ANOVA|||||||0.342
72499039|NCT02930174|144528269|EQUIVALENCE|Two devices were tested while measuring the differences in lung impedance under multiple pressure settings to determine whether the devices perform in an equivalent fashion. We looked at the mean differences between the 2 devices across the 4 pressure settings.|Mean Difference (Final Values)|0.1|STANDARD_DEVIATION|2.0||0.184|TWO_SIDED||||||ANOVA|||||||0.184
72499040|NCT02930174|144528270|EQUIVALENCE|Two devices were tested while measuring the differences in lung impedance under multiple pressure settings to determine whether the devices perform in an equivalent fashion. We looked at the mean differences between the 2 devices across the 4 pressure settings.|Mean Difference (Final Values)|0.1|STANDARD_DEVIATION|2.0||0.283|TWO_SIDED||||||ANOVA|||||||0.283
72499041|NCT02930174|144528271|EQUIVALENCE|Two devices were tested while measuring the differences in lung impedance under multiple pressure settings to determine whether the devices perform in an equivalent fashion. We looked at the mean differences between the 2 devices across the 4 pressure settings.|Mean Difference (Final Values)|0.1|STANDARD_DEVIATION|2.0||0.204|TWO_SIDED||||||ANOVA|||||||0.204
72499042|NCT02930174|144528272|EQUIVALENCE|Two devices were tested while measuring the differences in lung impedance under multiple pressure settings to determine whether the devices perform in an equivalent fashion. We looked at the mean differences between the 2 devices across the 4 pressure settings.|Mean Difference (Final Values)|0.1|STANDARD_DEVIATION|2.0||0.136|TWO_SIDED||||||ANOVA|||||||0.136
72561976|NCT03653026|144654949|SUPERIORITY||Adjusted Response Rate Difference|27.1|||<|0.001|TWO_SIDED|95.0|19.0|35.3||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Cochran-Mantel-Haenszel|Adjusted for Baseline corticosteroid use (yes or no), Baseline Adapted Mayo score (\<= 7 or \> 7), and bio-IR status (bio-IR or non-bio-IR).|Difference = Upadacitinib 45 mg - Placebo|||35.3|19.0|<0.001
72561977|NCT03653026|144654950|SUPERIORITY||Adjusted Response Rate Difference|29.1|||<|0.001|TWO_SIDED|95.0|20.9|37.4||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Cochran-Mantel-Haenszel|Adjusted for Baseline corticosteroid use (yes or no), Baseline Adapted Mayo score (≤ 7 or \> 7), and bio-IR status (bio-IR or non-bio-IR).|Difference = Upadacitinib 45 mg - Placebo|||37.4|20.9|<0.001
72619815|NCT02991859|144770744|OTHER||exponential power-law model|1986.05|||||TWO_SIDED|95.0|1574.7|2397.39|||||FP ED50 - Dose at which 50% of the maximum dose response reached (mcg)|||2397.39|1574.70|
72619816|NCT02991859|144770744|OTHER||exponential power-law model|176.09|||||TWO_SIDED|95.0|162.87|190.38|||||BUD E0 - Response of Placebo participants|||190.38|162.87|
72451354|NCT03635567|144423862|OTHER||Hazard Ratio (HR)|0.6|||<|0.0001|TWO_SIDED|95.0|0.49|0.74||No formal hypothesis testing performed; nominal p-value provided for treatment comparison.|Stratified Log-Rank|Nominal p-value based on log-rank test stratified by metastatic at initial diagnosis (FIGO \[2009\] stage IVB), bevacizumab use, and PD-L1 status.||Treatment comparison (HR) was based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by metastatic at initial diagnosis (FIGO \[2009\] stage IVB) (yes or no), bevacizumab use (yes or no), and PD-L1 status (CPS\<1, CPS 1 to \<10, or CPS ≥10).||0.74|0.49|<0.0001
72451355|NCT03635567|144423863|OTHER||Hazard Ratio (HR)|0.63|||<|0.0001|TWO_SIDED|95.0|0.52|0.77||No formal hypothesis testing performed; nominal p-value based on log-rank test provided for treatment comparison.|Stratified Log-Rank|Nominal p-value based on log-rank test stratified by metastatic at initial diagnosis (FIGO \[2009\] stage IVB), bevacizumab use, and PD-L1 status.||Treatment comparison (HR) was based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by metastatic at initial diagnosis (FIGO \[2009\] stage IVB) (yes or no), bevacizumab use (yes or no), and PD-L1 status (CPS\<1, CPS 1 to \<10, or CPS ≥10).||0.77|0.52|<0.0001
72451356|NCT03635567|144423864|OTHER||Hazard Ratio (HR)|0.58|||<|0.0001|TWO_SIDED|95.0|0.44|0.78||No formal hypothesis testing performed; nominal p-value provided for treatment comparison.|Stratified Log-Rank|Nominal p-value based on log-rank test stratified by metastatic at initial diagnosis (FIGO \[2009\] stage IVB), bevacizumab use, and PD-L1 status.||Treatment comparison (HR) was based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by metastatic at initial diagnosis (FIGO \[2009\] stage IVB) (yes or no), bevacizumab use (yes or no), and PD-L1 status (CPS\<1, CPS 1 to \<10, or CPS ≥10).||0.78|0.44|<0.0001
72451357|NCT03635567|144423865|OTHER||Difference in Percentage|14.9||||0.0001|TWO_SIDED|95.0|7.4|22.3||No formal hypothesis testing performed; nominal p-value provided for treatment comparison|Miettinen & Nurminen method|||Treatment comparison was based on Miettinen \& Nurminen method stratified by metastatic at initial diagnosis (FIGO \[2009\] stage IVB) (yes or no), bevacizumab use (yes or no), and PD-L1 status (CPS\<1, CPS 1 to \<10, or CPS ≥10).||22.3|7.4|0.0001
72451358|NCT03635567|144423868|OTHER||Hazard Ratio (HR)|0.6|||<|0.0001|TWO_SIDED|95.0|0.49|0.74||No formal hypothesis testing performed; nominal p-value provided for treatment comparison|Stratified Log-Rank|Nominal p-value based on log-rank test stratified by metastatic at initial diagnosis (FIGO \[2009\] stage IVB), bevacizumab use, and PD-L1 status.||Treatment comparison (HR) was based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by metastatic at initial diagnosis (FIGO \[2009\] stage IVB) (yes or no), bevacizumab use (yes or no), and PD-L1 status (CPS\<1, CPS 1 to \<10, or CPS ≥10).||0.74|0.49|<0.0001
72451359|NCT05157841|144423874|SUPERIORITY|A one-sided hypothesis test was performed at alpha=0.025 level of significance comparing EXPAREL and bupivacaine HCI|Mean Difference (Final Values)|-164.0|STANDARD_ERROR_OF_MEAN|27.74|<|1e-05|TWO_SIDED|95.0|-218.3|-109.6|||ANCOVA|Main effect of treatment, categorical covariate of pooled Investigator site, and continuous covariates of age||The superiority of EXPAREL to bupivacaine hydrochloric acid (HCI) was evaluated using the Efficacy Analysis Set.||-109.6|-218.3|<0.00001
72451360|NCT05157841|144423875|SUPERIORITY|A one-sided hypothesis test was performed at alpha=0.025 level of significance comparing EXPAREL and bupivacaine HCI|Least square mean difference|0.39|||<|1e-05|TWO_SIDED|95.0|0.28|0.55|||ANCOVA|||The superiority of EXPAREL to bupivacaine hydrochloric acid (HCI) was evaluated using the Efficacy Analysis Set.||0.55|0.28|<0.00001
72451361|NCT05157841|144423876|SUPERIORITY||Odds Ratio (OR)|5.04||||0.0003|TWO_SIDED|95.0|2.01|12.62|||ANCOVA|||||12.62|2.01|0.0003
72499043|NCT00151892|144528273|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|A 2-sided 95% confidence interval (CI) for the difference in the percentages of subjects in remission at 6 months of the two treatment groups will be computed. Non-inferiority of SPD476 to Asacol will be concluded if the lower limit of the 95% CI lies above the non-inferiority margin of -10%.|Difference in proportions|0.02||||||95.0|-0.04|0.08||||||The null hypothesis to be tested is that the true difference in proportions is less than or equal to -10%.||0.08|-0.04|
72451362|NCT05157841|144423877|SUPERIORITY||Hazard Ratio (HR)|0.65||||0.0089|TWO_SIDED|95.0|0.45|0.93|||Cox proportional hazards model|Cox proportional hazards model with treatment as main effect and site as categorical and age as continuous covariates.||||0.93|0.45|0.0089
72451363|NCT05157841|144423878|SUPERIORITY||Least square mean difference|-0.8|STANDARD_ERROR_OF_MEAN|0.44||0.0296|TWO_SIDED|95.0|-1.7|0.0||Worst pain 0-24 hours|ANCOVA|Main effect of treatment, categorical covariate of pooled Investigator site, and continuous covariate of age.||||0.0|-1.7|0.0296
72451364|NCT05157841|144423878|SUPERIORITY||Least square mean difference|-2.9|STANDARD_ERROR_OF_MEAN|0.4|<|1e-05|TWO_SIDED|95.0|-3.6|-2.1||Worst pain 24-48 hours|ANCOVA|Main effect of treatment, categorical covariate of pooled Investigator site, and continuous covariates of age||||-2.1|-3.6|<0.00001
72451365|NCT05157841|144423878|SUPERIORITY||Least square mean difference|-3.3|STANDARD_ERROR_OF_MEAN|0.41|<|1e-05|TWO_SIDED|95.0|-4.1|-2.5||Worst pain 48-72 hours|ANCOVA|Main effect of treatment, categorical covariate of pooled Investigator site, and continuous covariates of age||||-2.5|-4.1|<0.00001
72451366|NCT05157841|144423878|SUPERIORITY||Least square mean difference|-2.1|STANDARD_ERROR_OF_MEAN|0.43|<|1e-05|TWO_SIDED|95.0|-3.0|-1.3||Worst pain 72-96 hours|ANCOVA|Main effect of treatment, categorical covariate of pooled Investigator site, and continuous covariates of age||||-1.3|-3.0|<0.00001
72451367|NCT05157841|144423878|SUPERIORITY||Least square mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.36||0.3419|TWO_SIDED|95.0|-0.9|0.6||Average pain 0-24 hours|ANCOVA|Main effect of treatment, categorical covariate of pooled Investigator site, and continuous covariates of age||||0.6|-0.9|0.3419
72451368|NCT05157841|144423878|SUPERIORITY||Least square mean difference|-1.9|STANDARD_ERROR_OF_MEAN|0.31|<|1e-05|TWO_SIDED|95.0|-2.5|-1.3||Average pain 24-48 hours|ANCOVA|Main effect of treatment, categorical covariate of pooled Investigator site, and continuous covariates of age||||-1.3|-2.5|<0.00001
72451369|NCT05157841|144423878|SUPERIORITY||Least square mean difference|-2.2|STANDARD_ERROR_OF_MEAN|0.31|<|1e-05|TWO_SIDED|95.0|-2.8|-1.6||Average pain 48-72 hours|ANCOVA|Main effect of treatment, categorical covariate of pooled Investigator site, and continuous covariates of age||||-1.6|-2.8|<0.00001
72451370|NCT05157841|144423878|SUPERIORITY||Least square mean difference|-1.5|STANDARD_ERROR_OF_MEAN|0.31|<|1e-05|TWO_SIDED|95.0|-2.1|-0.9||Average pain 72-96 hours|ANCOVA|Main effect of treatment, categorical covariate of pooled Investigator site, and continuous covariates of age||||-0.9|-2.1|<0.00001
72619817|NCT02991859|144770744|OTHER||exponential power-law model|1927.42|||||TWO_SIDED|95.0|1698.47|2156.37|||||BUD ED50 - Dose at which 50% of the maximum dose response reached (mcg)|||2156.37|1698.47|
72451371|NCT03839446|144424036|SUPERIORITY||Hazard Ratio (HR)|0.8||||0.777|TWO_SIDED|95.0|0.18|3.65|||Regression, Cox||Intermediate / Favorable vs Poor|Cytogenetic status||3.65|0.18|0.777
72499044|NCT02901431|144528278|SUPERIORITY||Difference in Adjusted LSMeans|-0.16||||0.911|TWO_SIDED|90.0|-2.56|2.23|||Mixed Models Analysis|||||2.23|-2.56|0.911
72619818|NCT02991859|144770745|OTHER||Emax Model|289.73|||||TWO_SIDED|95.0|224.82|354.64|||||ED20 Cortisol Suppression 0-24 Hours Weighted Mean|||354.64|224.82|
72451372|NCT03839446|144424036|SUPERIORITY||Hazard Ratio (HR)|0.98||||0.2|TWO_SIDED|95.0|0.96|1.01|||Regression, Cox|||Percent of blasts present in the bone marrow.||1.01|0.96|0.200
72451373|NCT03839446|144424036|SUPERIORITY||Hazard Ratio (HR)|0.96||||0.014|TWO_SIDED|95.0|0.94|0.99|||Regression, Cox|||% CD33 expression in leukemia blasts||0.99|0.94|0.014
72451374|NCT03839446|144424037|SUPERIORITY||Hazard Ratio (HR)|0.82||||0.801|TWO_SIDED|95.0|0.17|3.86|||Regression, Cox||Intermediate / Favorable vs Poor|Cytogenetic status||3.86|0.17|0.801
72451375|NCT03839446|144424037|SUPERIORITY||Hazard Ratio (HR)|0.98||||0.168|TWO_SIDED|95.0|0.95|1.01|||Regression, Cox|||% bone marrow blasts||1.01|0.95|0.168
72619819|NCT02991859|144770745|OTHER||Emax Model|194.09|||||TWO_SIDED|95.0|72.82|517.28|||||ED80 for AMP PC20|||517.28|72.82|
72451376|NCT03839446|144424037|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.015|TWO_SIDED|95.0|0.94|0.99|||Regression, Cox|||% CD33 expression in leukemia blasts||0.99|0.94|0.015
72451377|NCT01527188|144424038|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-198.18||||0.0427|TWO_SIDED|95.0|-389.82|-6.55|||ANCOVA|||||-6.55|-389.82|0.0427
72451378|NCT01527188|144424038|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-171.82||||0.0793||95.0|-363.87|20.24|||ANCOVA|||||20.24|-363.87|0.0793
72451379|NCT01527188|144424038|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-118.43|||||TWO_SIDED|95.0|-305.9|69.04|||ANCOVA|||The statistical test is not applicable due to the step-down approach performed to address the multiplicity issue.||69.04|-305.90|
72451380|NCT01527188|144424039|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-125.61||||0.0323||95.0|-240.53|-10.69|||ANCOVA|||||-10.69|-240.53|0.0323
72451381|NCT01527188|144424039|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-122.23||||0.0376||95.0|-237.38|-7.08|||ANCOVA|||||-7.08|-237.38|0.0376
72451382|NCT01527188|144424039|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-91.18||||0.1119||95.0|-203.74|21.38|||ANCOVA|||||21.38|-203.74|0.1119
72451383|NCT03512301|144424071|OTHER||Accuracy|0.6587|||||TWO_SIDED|95.0|0.569|0.7408||||||||0.7408|0.5690|
72451384|NCT03512301|144424071|OTHER||Sensitivity|0.8736|||||TWO_SIDED|||||||||||||
72451385|NCT03512301|144424071|OTHER||Specificity|0.4872|||||TWO_SIDED|||||||||||||
72451386|NCT03512301|144424071|OTHER||Positive Predictive Value|0.7917|||||TWO_SIDED|||||||||||||
72451387|NCT03512301|144424071|OTHER||Negative Predictive Value|0.6333|||||TWO_SIDED|||||||||||||
72451388|NCT03512301|144424071|OTHER||Sensitivity|0.1212|||||TWO_SIDED|||||||||||||
72451389|NCT03512301|144424071|OTHER||Specificity|0.9032|||||TWO_SIDED|||||||||||||
72451390|NCT03512301|144424071|OTHER||Positive Predictive Value|0.3077|||||TWO_SIDED|||||||||||||
72451391|NCT03512301|144424071|OTHER||Negative Predictive Value|0.7434|||||TWO_SIDED|||||||||||||
72451392|NCT03512301|144424071|OTHER||Sensitivity|0.5|||||TWO_SIDED|||||||||||||
72451393|NCT03512301|144424071|OTHER||Specificity|0.8833|||||TWO_SIDED|||||||||||||
72451394|NCT03512301|144424071|OTHER||Positive Predictive Value|0.1765|||||TWO_SIDED|||||||||||||
72451395|NCT03512301|144424071|OTHER||Negative Predictive Value|0.9725|||||TWO_SIDED|||||||||||||
72451396|NCT03512301|144424071|OTHER||Quadratic Weighted Kappa|0.4446|||||TWO_SIDED|95.0|0.2791|0.6101||||||||0.6101|0.2791|
72451397|NCT03512301|144424072|OTHER|Linear Regression. Power calculations for linear regression between CAMCI and MoCA were found to be sufficiently powered with a Pearson's R of at least 0.3 at 80% power and that equated to a test-set size of 98.|Pearson Correlation|0.5073|||||TWO_SIDED|95.0|0.3892|0.6091|||||Linear Regression Equation: \[CAMCI Score\] = -5.42 + 1.40 X \[MoCA Score\]|||0.6091|0.3892|
72451398|NCT03512301|144424072|OTHER||Accuracy|0.5556|||||TWO_SIDED|95.0|0.4644|0.644||||||||0.6440|0.4644|
72451399|NCT03512301|144424072|OTHER||Sensitivity|0.9747|||||TWO_SIDED|||||||||||||
72451400|NCT03512301|144424072|OTHER||Specificity|0.3913|||||TWO_SIDED|||||||||||||
72451401|NCT03512301|144424072|OTHER||Positive Predictive Value|0.5625|||||TWO_SIDED|||||||||||||
72451402|NCT03512301|144424072|OTHER||Negative Predictive Value|0.9|||||TWO_SIDED|||||||||||||
72451403|NCT03512301|144424072|OTHER||Sensitivity|0.1905|||||TWO_SIDED|||||||||||||
72451404|NCT03512301|144424072|OTHER||Specificity|0.9841|||||TWO_SIDED|||||||||||||
72451405|NCT03512301|144424072|OTHER||Positive Predictive Value|0.9231|||||TWO_SIDED|||||||||||||
72451406|NCT03512301|144424072|OTHER||Negative Predictive Value|0.5487|||||TWO_SIDED|||||||||||||
72451407|NCT03512301|144424072|OTHER||Sensitivity|0.6667|||||TWO_SIDED|||||||||||||
72451408|NCT03512301|144424072|OTHER||Specificity|0.8917|||||TWO_SIDED|||||||||||||
72451409|NCT03512301|144424072|OTHER||Positive Predictive Value|0.2353|||||TWO_SIDED|||||||||||||
72499045|NCT02901431|144528279|SUPERIORITY||Difference in adjused LSMean|0.29|||||TWO_SIDED|90.0|-1.85|2.43||||||Week 12||2.43|-1.85|
72499046|NCT02901431|144528279|SUPERIORITY||Difference in adjusted LSMean|-0.23|||||TWO_SIDED|90.0|-2.67|2.22||||||Week 24||2.22|-2.67|
72499047|NCT02901431|144528280|SUPERIORITY||Difference in adjusted LSMean|-0.22|||||TWO_SIDED|90.0|-2.36|1.92||||||Communication Domain Standard Score, Week 12||1.92|-2.36|
72619820|NCT02991859|144770746|OTHER||Emax Model|639.36|||||TWO_SIDED|95.0|506.94|771.79|||||ED20 for Cortisol Suppression 0-24 Hours Weighted Mean|||771.79|506.94|
72619821|NCT02991859|144770746|OTHER||Emax Model|4325.07|||||TWO_SIDED|95.0|1792.02|10438.64|||||ED80 for AMP PC20|||10438.64|1792.02|
72619822|NCT02991859|144770747|OTHER||Emax Model|620.49|||||TWO_SIDED|95.0|546.79|694.2|||||ED20 for Cortisol Suppression 0-24 Hours Weighted Mean|||694.20|546.79|
72619823|NCT02991859|144770747|OTHER||Emax Model|5869.45|||||TWO_SIDED|95.0|2186.03|15759.35|||||ED80 for AMP PC20|||15759.35|2186.03|
72619824|NCT04223687|144770808|SUPERIORITY||||||<|0.01||||||a priori threshold for statistical significance, p\<0.05|Chi-squared|||||||<0.01
72451410|NCT03512301|144424072|OTHER||Negative Predictive Value|0.9817|||||TWO_SIDED|||||||||||||
72451411|NCT03512301|144424072|OTHER||Quadratic Weighted Kappa|0.3931|||||TWO_SIDED|95.0|0.2401|0.5461||||||||0.5461|0.2401|
72451412|NCT04933474|144424080|OTHER|||||||0.088|||||||Chi-squared|||The primary outcome will be the baseline vs. week 8 difference-in-difference in 7-day average NRS pain intensity scores, dichotomized into if the MCID of 2 is achieved. The between arm difference of achieving the MCID of 2 will be tested using Chi-squared test.||||0.088
72619825|NCT04223687|144770809|SUPERIORITY||||||<|0.01||||||a priori threshold for statistical significance, p\<0.05|t-test, 2 sided|||||||<0.01
72451413|NCT04933474|144424081|OTHER|||||||0.103|||||||t-test, 2 sided|||A two-sample t-test will be used to compare differences-in-differences between the arms.||||0.103
72451414|NCT04933474|144424082|OTHER|||||||0.774|||||||t-test, 2 sided|||A two-sample t-test will be used to compare differences-in-differences between the arms.||||0.774
72451415|NCT04933474|144424083|OTHER|||||||0.005|||||||t-test, 2 sided|||A two-sample t-test will be used to compare differences-in-differences between the arms.||||0.005
72619826|NCT04223687|144770810|SUPERIORITY|||||||0.03||||||a priori threshold for statistical significance, p\<0.05|Wilcoxon (Mann-Whitney)|||||||0.03
72451416|NCT04933474|144424084|OTHER|||||||0.831|||||||t-test, 2 sided|||A two-sample t-test will be used to compare differences-in-differences between the arms.||||0.831
72451417|NCT04933474|144424085|OTHER||Common Odds Ratio|1.44||||0.031|TWO_SIDED|95.0|1.03|2.02||A two-sided test performed at the 0.05 level of significance without the continuity correction.|Cochran-Mantel-Haenszel|||The Cochran-Mantel-Haenszel (CMH) test was used to compare the association between time (baseline and week 8) and opioid use (yes or no) while stratifying for the treatment groups. The null hypothesis is that the common odds ratio of the association between time and response across the treatment groups is equal to 1, versus the alternative hypothesis that the common odds ratio is not equal to 1.||2.02|1.03|0.031
72451418|NCT01992913|144424231|SUPERIORITY||||||<|0.05||||||"Fisher's exact Test, right-sided probability based on a directional hypothesis."|Fisher Exact|||We conducted a 2 X 2 chi-square analysis of differences in proportion.||||<.05
72451419|NCT01992913|144424231|SUPERIORITY||Odds Ratio (OR)|2.65|||<|0.06|TWO_SIDED|95.0|0.97|7.13|||Chi-squared|ChiSq = 3.6562, df = 1|OR, iCBT / TAU in job attainment|Chis Sq: group (iCBT/TAU) X Job attained (Yes/No)||7.13|0.97|<.06
72451420|NCT01992913|144424232|SUPERIORITY|A mixed effects logistic regression model was conducted on a binary work variable, with a random intercept, using the baseline measure as a binary covariate.|Odds Ratio, log|-0.9|STANDARD_ERROR_OF_MEAN|0.91|<|0.33|TWO_SIDED|95.0|-2.67|0.89|||Mixed Models Analysis|df (1, 30) for the group X assessment interaction, adjusting for baseline differences in hours worked at the start of the intervention.||Compare the groups on proportions in employment at the 6 month assessment points.||.89|-2.67|<0.33
72451421|NCT01992913|144424232|SUPERIORITY|A mixed effects logistic regression model was conducted on a binary work variable, with a random intercept, using the baseline measure as a binary covariate.|Odds Ratio, log|0.52|STANDARD_ERROR_OF_MEAN|0.85|<|0.54|TWO_SIDED|95.0|-1.14|2.19|||Mixed Models Analysis|F (1, 130) = 1.0, p\<0.37, for the group X assessment interaction, adjusting for baseline differences in hours worked at the start of the intervention.||Compare the groups on proportions in employment at the 12 month assessment points.||2.19|-1.14|<.54
72451422|NCT01992913|144424232|SUPERIORITY|A mixed effects logistic regression model was conducted on a binary work variable, with a random intercept, using the baseline measure as a binary covariate.|Odds Ratio, log|0.31|STANDARD_ERROR_OF_MEAN|0.83|<|0.71|TWO_SIDED|95.0|-1.32|1.73|||Mixed Models Analysis|F (1, 130) = 1.0, p\<0.37, for the group X assessment interaction, adjusting for baseline differences in hours worked at the start of the intervention.||Compare the groups on proportions in employment at the 18 month assessment point.||1.73|-1.32|<0.71
72451423|NCT01992913|144424234|SUPERIORITY|This is mixed model analysis of the group X assessment interaction. This analysis is the test of mean differences in level of functioning at the baseline assessment.|Mean Difference (Final Values)|-5.03|STANDARD_ERROR_OF_MEAN|3.82|<|0.19|TWO_SIDED||||||Fisher Exact|df (1, 114)||||||<0.19
72451424|NCT01992913|144424234|SUPERIORITY|This is mixed model analysis of the group X assessment interaction. This analysis is the test of mean differences in level of functioning at the 6 month assessment.|Mean Difference (Final Values)|0.03|STANDARD_ERROR_OF_MEAN|4.42|<|0.99|TWO_SIDED||||||Fisher Exact|df (1, 114)||||||<0.99
72451425|NCT01992913|144424234|SUPERIORITY|This is mixed model analysis of the group X assessment interaction. This analysis is the test of mean differences in level of functioning at the 12 month assessment.|Mean Difference (Final Values)|-0.33|STANDARD_ERROR_OF_MEAN|4.54|<|0.94|TWO_SIDED||||||Fisher Exact|df (1, 114)||||||<0.94
72451426|NCT01992913|144424234|SUPERIORITY|This is mixed model analysis of the group X assessment interaction. This analysis is the test of mean differences in level of functioning at the baseline assessment.|Mean Difference (Final Values)|-6.67|STANDARD_ERROR_OF_MEAN|4.52|<|0.14|TWO_SIDED||||||Fisher Exact|df (1, 114)||||||<0.14
72469963|NCT01512797|144463888|OTHER|||||||0.028||||||P-value refers to paired t-test comparing pre-intervention and post-intervention timepoints in Sitagliptin group.|t-test, 2 sided|||Power analysis. Based on the effect of DPP-4 inhibitors in non-operated subjects with type 2 diabetes, showing a significant decrease in 120' post-prandial glucose by 1.67 mmol/L ± 0.98 mmol/L after a MMT, we estimated that a sample size of 16 subjects per group will show post-prandial glucose differences between placebo and sitagliptin group with α = 0.05 for a power \> 90%.||||0.028
72499048|NCT02901431|144528280|SUPERIORITY||Difference in adjusted LSMean|0.71|||||TWO_SIDED|90.0|-1.6|3.02||||||Communication Domain Standard Score, Week 24||3.02|-1.60|
72619827|NCT04223687|144770811|SUPERIORITY|||||||0.37||||||a priori threshold for statistical significance, p\<0.05|Chi-squared|||||||0.37
72619828|NCT04223687|144770812|SUPERIORITY||||||<|0.001||||||a priori threshold for statistical significance, p\<0.05|Wilcoxon (Mann-Whitney)|||||||<0.001
72619829|NCT04223687|144770813|SUPERIORITY||||||<|0.001||||||a priori threshold for statistical significance, p\<0.05|Wilcoxon (Mann-Whitney)|||||||<0.001
72619830|NCT04223687|144770814|SUPERIORITY||||||<|0.001||||||a priori threshold for statistical significance, p\<0.05|Wilcoxon (Mann-Whitney)|||||||<0.001
72619831|NCT04223687|144770815|SUPERIORITY||||||<|0.001||||||a priori threshold for statistical significance, p\<0.05|Chi-squared|||||||<0.001
72619832|NCT04223687|144770816|SUPERIORITY|||||||0.06||||||a priori threshold for statistical significance, p\<0.05|Wilcoxon (Mann-Whitney)|||||||0.06
72451427|NCT00709956|144424261|SUPERIORITY_OR_OTHER_LEGACY||Difference in least squares mean|-1.5||||0.7883|TWO_SIDED|95.0|-12.3|9.4||If the primary endpoint reaches significance, treatment effect of the secondary endpoint is determined at a 2-sided nominal of 0.05. Since hierarchy of the endpoints to be tested has been predefined, no correction for multiple testing will be applied|Generalized linear model|Subject (sequence), treatment, and period as fixed effect||With a sample size of at least 63 patients and based on the assumptions on the primary endpoint (normal distribution, SD of the difference of 30 m) the study was designed to detect a significant treatment effect with 90% power, assuming a difference exceeding 12.5 m between the mean values of the 6MWD following the iloprost power 15 treatment and the one following the placebo treatment.||9.4|-12.3|0.7883
72451428|NCT04174170|144424279|SUPERIORITY||Treatment Difference|1.03||||0.5165|TWO_SIDED|95.0|-2.09|4.16|||MMRM|||||4.16|-2.09|0.5165
72451429|NCT04174170|144424279|SUPERIORITY||Treatment Difference|-0.71||||0.6593|TWO_SIDED|95.0|-3.88|2.46|||MMRM|||||2.46|-3.88|0.6593
72451430|NCT04174170|144424280|SUPERIORITY||Treatment Difference|0.03||||0.8215|TWO_SIDED|95.0|-0.25|0.31||MMRM method with model terms: treatment, (pooled) study center, previous pharmacological treatment intervention for PTSD (yes/no), visit, treatment by visit and baseline by visit interaction.|MMRM|||||0.31|-0.25|0.8215
72451431|NCT04174170|144424280|SUPERIORITY||Treatment Difference|-0.03||||0.8584|TWO_SIDED|95.0|-0.31|0.26||MMRM method with model terms: treatment, (pooled) study center, previous pharmacological treatment intervention for PTSD (yes/no), visit, treatment by visit and baseline by visit interaction.|MMRM|||||0.26|-0.31|0.8584
72451432|NCT04174170|144424281|SUPERIORITY||Treatment Difference|-4.16||||0.2331|TWO_SIDED|95.0|-11.0|2.69||MMRM method with model terms: treatment, (pooled) study center, previous pharmacological treatment intervention for PTSD (yes/no), visit, treatment by visit and baseline by visit interaction.|MMRM|||||2.69|-11.00|0.2331
72451433|NCT04174170|144424281|SUPERIORITY||Treatment Difference|-8.83||||0.0134|TWO_SIDED|95.0|-15.82|-1.85||MMRM method with model terms: treatment, (pooled) study center, previous pharmacological treatment intervention for PTSD (yes/no), visit, treatment by visit and baseline by visit interaction.|MMRM|||||-1.85|-15.82|0.0134
72451434|NCT04586244|144424393|SUPERIORITY|||||||0.0925|||||||paired t-test|The paired t-test used n-1 degrees of freedom, where n is the number of evaluable paired samples.||||||0.0925
72451435|NCT03142009|144424400|SUPERIORITY||Mean Difference (Final Values)|-0.24||||0.021|TWO_SIDED|95.0|-0.45|-0.04|||Mixed Models Analysis|||||-.04|-.45|.021
72451436|NCT03142009|144424401|SUPERIORITY||Mean Difference (Final Values)|0.07||||0.075|TWO_SIDED|95.0|-0.01|0.15|||Mixed Models Analysis|||||0.15|-.01|.075
72451437|NCT01499368|144424403|NON_INFERIORITY|Non-inferiority: The Lower limit is not lower than -15%||||||0.05|||||||Chi-squared|||||||0.05
72451438|NCT01499368|144424404|NON_INFERIORITY|Non-Inferiority||||||0.05|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test||||||0.05
72451439|NCT02720068|144424465|OTHER|Difference in Percentage|Mean Difference (Final Values)|7.5|||||TWO_SIDED|95.0|-7.3|22.9|||||Confidence interval based on Miettinen \& Nurminen method|||22.9|-7.3|
72451440|NCT02231749|144424480|SUPERIORITY||Stratified Difference|16.0|||<|0.0001|TWO_SIDED|95.0|9.8|22.2|||DerSimonian and Laird Test|||||22.2|9.8|<0.0001
72451441|NCT02231749|144424481|SUPERIORITY||Hazard Ratio (HR)|0.63|||<|0.0001|TWO_SIDED|99.8|0.44|0.89|||Log Rank|||||0.89|0.44|<0.0001
72451442|NCT02231749|144424482|SUPERIORITY||Hazard Ratio (HR)|0.82||||0.0331|TWO_SIDED|99.1|0.64|1.05|||Log Rank|||||1.05|0.64|0.0331
72451443|NCT02231749|144424483|SUPERIORITY||Stratified Difference|7.2||||0.0191|TWO_SIDED|95.0|1.8|12.7|||DerSimonian and Laird Test|||||12.7|1.8|0.0191
72451444|NCT02231749|144424484|SUPERIORITY||Hazard Ratio (HR)|0.68||||0.0003|TWO_SIDED|99.8|0.49|0.95|||Log Rank|||||0.95|0.49|0.0003
72451445|NCT02231749|144424485|SUPERIORITY||Hazard Ratio (HR)|0.98||||0.8498|TWO_SIDED|99.1|0.79|1.23|||Log Rank|||||1.23|0.79|0.8498
72451446|NCT05495945|144424617|SUPERIORITY|||||||0.62|||||||Wilcoxon (Mann-Whitney)|||||||0.62
72391338|NCT03000439|144289797|OTHER||Difference in percentage|13.13|||||TWO_SIDED|95.0|-9.92|36.19|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 20||36.19|-9.92|
72451447|NCT05495945|144424618|SUPERIORITY|||||||0.18|||||||Wilcoxon (Mann-Whitney)|||||||0.18
72451448|NCT05495945|144424619|SUPERIORITY|||||||0.2|||||||Wilcoxon (Mann-Whitney)|||||||0.20
72451449|NCT05495945|144424620|SUPERIORITY|||||||0.02|||||||Wilcoxon (Mann-Whitney)|||||||0.02
72451450|NCT03215706|144424627|SUPERIORITY|Treatment A over Treatment B|Hazard Ratio (HR)|0.69||||0.0006|TWO_SIDED|95.0|0.56|0.86|||Log-rank test stratified|||||0.86|0.56|0.0006
72451451|NCT03215706|144424628|SUPERIORITY|Treatment A over Treatment B|Hazard Ratio (HR)|0.7||||0.0001|TWO_SIDED|95.0|0.58|0.84|||Log-rank test stratified|||||0.84|0.58|0.0001
72451452|NCT03215706|144424629|SUPERIORITY|Treatment A over Treatment B|Odds Ratio (OR)|1.81||||0.0003|TWO_SIDED|95.0|1.31|2.5|||Mantel Haenszel|||||2.50|1.31|0.0003
72451453|NCT05412004|144424645|SUPERIORITY||LS Mean Change difference|-20.01|||<|0.001|TWO_SIDED|95.0|-25.82|-14.2|||ANCOVA|ANCOVA model was used with baseline, geographic region, sex, treatment (Type III sum of squares) as covariates.||||-14.20|-25.82|<0.001
72451454|NCT05412004|144424645|SUPERIORITY||LS Mean Change difference|-23.77|||<|0.001|TWO_SIDED|95.0|-29.61|-17.93|||ANCOVA|ANCOVA model was used with baseline, geographic region, sex, treatment (Type III sum of squares) as covariates.||||-17.93|-29.61|<0.001
72451455|NCT05412004|144424646|SUPERIORITY||LS Mean Change difference|-47.65|||<|0.001|TWO_SIDED|95.0|-65.76|-29.55|||ANCOVA|ANCOVA model was used with baseline, geographic region, sex, treatment (Type III sum of squares) as covariates.||||-29.55|-65.76|<0.001
72451456|NCT05412004|144424646|SUPERIORITY||LS Mean Change difference|-56.21|||<|0.001|TWO_SIDED|95.0|-73.73|-38.7|||ANCOVA|ANCOVA model was used with baseline, geographic region, sex, treatment (Type III sum of squares) as covariates.||||-38.70|-73.73|<0.001
72451457|NCT05412004|144424647|SUPERIORITY||Risk Difference (RD)|42.77|||<|0.001|TWO_SIDED|95.0|30.76|54.79|||Regression, Logistic|||||54.79|30.76|<0.001
72451458|NCT05412004|144424647|SUPERIORITY||Risk Difference (RD)|48.6|||<|0.001|TWO_SIDED|95.0|36.55|60.65|||Regression, Logistic|||||60.65|36.55|<0.001
72619833|NCT04223687|144770817|SUPERIORITY|||||||0.37||||||a priori threshold for statistical significance, p\<0.05|Wilcoxon (Mann-Whitney)|||||||0.37
72451459|NCT05412004|144424648|SUPERIORITY||Risk Difference (RD)|28.74|||<|0.001|TWO_SIDED|95.0|18.27|39.22|||Regression, Logistic|||||39.22|18.27|<.001
72451460|NCT05412004|144424648|SUPERIORITY||Risk Difference (RD)|33.22|||<|0.001|TWO_SIDED|95.0|22.12|44.31|||Regression, Logistic|||||44.31|22.12|<0.001
72451461|NCT05412004|144424649|SUPERIORITY||Median Difference (Net)|-70.13|STANDARD_ERROR_OF_MEAN|10.619|||TWO_SIDED|95.0|-90.94|-49.31||||||||-49.31|-90.94|
72451462|NCT05412004|144424649|SUPERIORITY||Median Difference (Net)|-61.29|STANDARD_ERROR_OF_MEAN|11.921|||TWO_SIDED|95.0|-84.66|-37.93||||||||-37.93|-84.66|
72451463|NCT05412004|144424650|SUPERIORITY||LS Mean Change difference|-2.03||||0.037|TWO_SIDED|95.0|-3.95|-0.12|||ANCOVA|ANCOVA model was used with baseline, geographic region, sex, baseline OSA severity Group, treatment (Type III sum of squares) as covariates.||Sleep Disturbance||-0.12|-3.95|0.037
72451464|NCT05412004|144424650|SUPERIORITY||LS Mean Change difference|-3.43||||0.003|TWO_SIDED|95.0|-5.69|-1.17|||ANCOVA|ANCOVA model was used with baseline, geographic region, sex, baseline OSA severity Group, treatment (Type III sum of squares) as covariates.||Sleep Related Impairment||-1.17|-5.69|0.003
72451465|NCT05412004|144424650|SUPERIORITY||LS Mean Change difference|-3.9|||<|0.001|TWO_SIDED|95.0|-6.21|-1.58|||ANCOVA|ANCOVA model was used with baseline, geographic region, sex, baseline OSA severity Group, treatment (Type III sum of squares) as covariates.||Sleep Disturbance||-1.58|-6.21|<0.001
72451466|NCT05412004|144424650|SUPERIORITY||LS Mean Change difference|-4.26||||0.002|TWO_SIDED|95.0|-6.97|-1.56|||ANCOVA|ANCOVA model was used with baseline, geographic region, sex, baseline OSA severity Group, treatment (Type III sum of squares) as covariates.||Sleep-Related Impairment||-1.56|-6.97|0.002
72561978|NCT03653026|144654951|SUPERIORITY||Adjusted Response Rate Difference|37.9|||<|0.001|TWO_SIDED|95.0|29.8|46.1||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Cochran-Mantel-Haenszel|Adjusted for Baseline corticosteroid use (yes or no), Baseline Adapted Mayo score (≤ 7 or \> 7), and bio-IR status (bio-IR or non-bio-IR).|Difference = Upadacitinib 45 mg - Placebo|||46.1|29.8|<0.001
72451467|NCT05412004|144424651|SUPERIORITY||LS Mean Change difference|-16.09|||<|0.001|TWO_SIDED|95.0|-17.99|-14.19|||ANCOVA|ANCOVA model was used with baseline, geographic region, sex, baseline OSA severity Group, treatment (Type III sum of squares) as covariates.||||-14.19|-17.99|<0.001
72451468|NCT05412004|144424651|SUPERIORITY||LS Mean Change difference|-17.28|||<|0.001|TWO_SIDED|95.0|-19.29|-15.28|||ANCOVA|ANCOVA model was used with baseline, geographic region, sex, baseline OSA severity Group, treatment (Type III sum of squares) as covariates.||||-15.28|-19.29|<.001
72451469|NCT05412004|144424652|SUPERIORITY||LS Mean Change difference|-0.71|STANDARD_ERROR_OF_MEAN|0.253||0.752|TWO_SIDED|95.0|-1.21|-0.22||ANCOVA model was used with baseline, geographic region, sex, baseline OSA severity Group, treatment (Type III sum of squares) as covariates.|ANCOVA|||||-0.22|-1.21|0.752
72451470|NCT05412004|144424652|SUPERIORITY||LS Mean Change difference|-1.04|STANDARD_ERROR_OF_MEAN|0.269||0.35|TWO_SIDED|95.0|-1.57|-0.51||ANCOVA model was used with baseline, geographic region, sex, baseline OSA severity Group, treatment (Type III sum of squares) as covariates.|ANCOVA|||||-0.51|-1.57|0.350
72451471|NCT05412004|144424653|SUPERIORITY||LS Mean Change difference|-7.62|||<|0.001|TWO_SIDED|95.0|-10.48|-4.77|||ANCOVA|ANCOVA model was used with baseline, geographic region, sex, baseline OSA severity Group, treatment (Type III sum of squares) as covariates.||||-4.77|-10.48|<0.001
72451472|NCT05412004|144424653|SUPERIORITY||LS Mean difference|-3.7||||0.017|TWO_SIDED|95.0|-6.75|-0.65|||ANCOVA|ANCOVA model was used with baseline, geographic region, sex, baseline OSA severity Group, treatment (Type III sum of squares) as covariates.||||-0.65|-6.75|0.017
72451473|NCT03868930|144424724|SUPERIORITY||||||<|0.0001||||||P-value indicates significance of T-test (α=0.05) for the STEP-Home group from Baseline (T1) to Post-Treatment (T2).|t-test, 2 sided|||"Hypothesis 1: Participants randomized into the STEP-Home Intervention will show improvement on reintegration (measured by the Military to Civilian Questionnaire).~Hypothesis 2: Treatment effects will be maintained at follow-up for both groups"||||<.0001
72451474|NCT03868930|144424724|SUPERIORITY||||||<|0.0001||||||P-value indicates significance of T-test (α=0.05) for the STEP-Home group from Baseline (T1) to Follow-Up (T3).|t-test, 2 sided|||"Hypothesis 1: Participants randomized into the STEP-Home Intervention will show improvement on reintegration (measured by the Military to Civilian Questionnaire).~Hypothesis 2: Treatment effects will be maintained at follow-up for both groups"||||<.0001
72451475|NCT03868930|144424724|SUPERIORITY||||||<|0.0001||||||P-value indicates significance of T-test (α=0.05) for the Present Centered Group Therapy group from Baseline (T1) to Post-Treatment (T2).|t-test, 2 sided|||"Hypothesis 1: Participants randomized into the STEP-Home Intervention will show improvement on reintegration (measured by the Military to Civilian Questionnaire).~Hypothesis 2: Treatment effects will be maintained at follow-up for both groups"||||<.0001
72451476|NCT03868930|144424724|SUPERIORITY||||||<|0.0001||||||P-value indicates significance of T-test (α=0.05) for the Present Centered Group Therapy group from Baseline (T1) to Follow-Up (T3).|t-test, 2 sided|||"Hypothesis 1: Participants randomized into the STEP-Home Intervention will show improvement on reintegration (measured by the Military to Civilian Questionnaire).~Hypothesis 2: Treatment effects will be maintained at follow-up for both groups"||||<.0001
72451477|NCT03868930|144424725|SUPERIORITY|||||||0.0044||||||P-value indicates significance of T-test (α=0.05) for the STEP-Home group from Baseline (T1) to Post-Treatment (T2).|t-test, 2 sided|||"Hypothesis 1: Participants randomized into the STEP-Home Intervention will show improvement on readjustment (measured by the Post Deployment Readjustment Inventory).~Hypothesis 2: Treatment effects will be maintained at follow-up for both groups~Statistical analysis reported on the total score only."||||0.0044
72499049|NCT02901431|144528280|SUPERIORITY||Difference in adjusted LSMean|0.51|||||TWO_SIDED|90.0|-2.1|3.12||||||Socialization Domain Standard Score, Week 12||3.12|-2.10|
72561979|NCT03653026|144654952|SUPERIORITY||Least Squares (LS) Mean Difference|31.2|STANDARD_ERROR_OF_MEAN|3.15|<|0.001|TWO_SIDED|95.0|24.98|37.36||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Mixed-effect model repeated measurement|MMRM with Baseline, treatment, visit, treatment-by-visit interaction, and strata (Baseline Adapted Mayo score, corticosteroid use, and bio-IR status).|Difference = Upadacitinib 45 mg - Placebo|||37.36|24.98|<0.001
72451478|NCT03868930|144424725|SUPERIORITY||||||<|0.0001||||||P-value indicates significance of T-test (α=0.05) for the STEP-Home group from Baseline (T1) to Follow-Up (T3).|t-test, 2 sided|||"Hypothesis 1: Participants randomized into the STEP-Home Intervention will show improvement on readjustment (measured by the Post Deployment Readjustment Inventory).~Hypothesis 2: Treatment effects will be maintained at follow-up for both groups~Statistical analysis reported on the total score only."||||<.0001
72451479|NCT03868930|144424725|SUPERIORITY|||||||0.0162||||||P-value indicates significance of T-test (α=0.05) for the Present Centered Group Therapy group from Baseline (T1) to Post-Treatment (T2).|t-test, 2 sided|||"Hypothesis 1: Participants randomized into the STEP-Home Intervention will show improvement on readjustment (measured by the Post Deployment Readjustment Inventory).~Hypothesis 2: Treatment effects will be maintained at follow-up for both groups~Statistical analysis reported on the total score only."||||0.0162
72451480|NCT03868930|144424725|SUPERIORITY|||||||0.0009||||||P-value indicates significance of T-test (α=0.05) for the Present Centered Group Therapy group from Baseline (T1) to Follow-Up (T3).|t-test, 2 sided|||"Hypothesis 1: Participants randomized into the STEP-Home Intervention will show improvement on readjustment (measured by the Post Deployment Readjustment Inventory).~Hypothesis 2: Treatment effects will be maintained at follow-up for both groups~Statistical analysis reported on the total score only."||||0.0009
72451481|NCT03868930|144424726|SUPERIORITY|||||||0.014||||||P-value indicates significance of T-test (α=0.05) for the STEP-Home group from Baseline (T1) to Post-Treatment (T2) Trait Anger.|t-test, 2 sided|||"Hypothesis 1: Participants randomized into the STEP-Home Intervention will show improvement on anger as measured by the State-Trait Anger Expression Inventory (STAXI).~Hypothesis 2: Treatment effects will be maintained at follow-up for both groups"||||0.0140
72451482|NCT03868930|144424726|SUPERIORITY|||||||0.1548||||||P-value indicates significance of T-test (α=0.05) for the STEP-Home group from Baseline (T1) to Post-Treatment (T2) State Anger.|t-test, 2 sided|||"Hypothesis 1: Participants randomized into the STEP-Home Intervention will show improvement on anger as measured by the State-Trait Anger Expression Inventory (STAXI).~Hypothesis 2: Treatment effects will be maintained at follow-up for both groups"||||0.1548
72451483|NCT03868930|144424726|SUPERIORITY|||||||0.0302||||||P-value indicates significance of T-test (α=0.05) for the STEP-Home group from Baseline (T1) to Post-Treatment (T2) Anger Expression Index.|t-test, 2 sided|||"Hypothesis 1: Participants randomized into the STEP-Home Intervention will show improvement on anger as measured by the State-Trait Anger Expression Inventory (STAXI).~Hypothesis 2: Treatment effects will be maintained at follow-up for both groups"||||0.0302
72451484|NCT03868930|144424726|SUPERIORITY|||||||0.0158||||||P-value indicates significance of T-test (α=0.05) for the Present Centered Group Therapy group from Baseline (T1) to Post-Treatment (T2) Trait Anger.|t-test, 2 sided|||"Hypothesis 1: Participants randomized into the STEP-Home Intervention will show improvement on anger as measured by the State-Trait Anger Expression Inventory (STAXI).~Hypothesis 2: Treatment effects will be maintained at follow-up for both groups"||||0.0158
72619834|NCT04223687|144770818|SUPERIORITY||||||<|0.001||||||a priori threshold for statistical significance, p\<0.05|Wilcoxon (Mann-Whitney)|||||||<0.001
72451485|NCT03868930|144424726|SUPERIORITY|||||||0.0034||||||P-value indicates significance of T-test (α=0.05) for the Present Centered Group Therapy group from Baseline (T1) to Post-Treatment (T2) State Anger.|t-test, 2 sided|||"Hypothesis 1: Participants randomized into the STEP-Home Intervention will show improvement on anger as measured by the State-Trait Anger Expression Inventory (STAXI).~Hypothesis 2: Treatment effects will be maintained at follow-up for both groups"||||0.0034
72451486|NCT03868930|144424726|SUPERIORITY|||||||0.8776||||||P-value indicates significance of T-test (α=0.05) for the Present Centered Group Therapy group from Baseline (T1) to Post-Treatment (T2) Anger Expression Index.|t-test, 2 sided|||"Hypothesis 1: Participants randomized into the STEP-Home Intervention will show improvement on anger as measured by the State-Trait Anger Expression Inventory (STAXI).~Hypothesis 2: Treatment effects will be maintained at follow-up for both groups"||||0.8776
72451487|NCT03868930|144424726|SUPERIORITY|||||||0.0002||||||P-value indicates significance of T-test (α=0.05) for the STEP-Home group from Baseline (T1) to Follow-Up (T3) Trait Anger.|t-test, 2 sided|||"Hypothesis 1: Participants randomized into the STEP-Home Intervention will show improvement on anger as measured by the State-Trait Anger Expression Inventory (STAXI).~Hypothesis 2: Treatment effects will be maintained at follow-up for both groups"||||0.0002
72451488|NCT03868930|144424726|SUPERIORITY|||||||0.0198||||||P-value indicates significance of T-test (α=0.05) for the STEP-Home group from Baseline (T1) to Follow-Up (T3) State Anger.|t-test, 2 sided|||"Hypothesis 1: Participants randomized into the STEP-Home Intervention will show improvement on anger as measured by the State-Trait Anger Expression Inventory (STAXI).~Hypothesis 2: Treatment effects will be maintained at follow-up for both groups"||||0.0198
72499050|NCT02901431|144528280|SUPERIORITY|Socialization Domain Standard Score, Week 24|Difference in adjusted LSMean|-0.61|||||TWO_SIDED|90.0|-3.74|2.51||||||||2.51|-3.74|
72499051|NCT02901431|144528280|SUPERIORITY|Daily Living Skills Domain Standard Score, Week 12|Difference in adjusted LSMean|2.14|||||TWO_SIDED|90.0|-0.63|4.9||||||||4.90|-0.63|
72499052|NCT02901431|144528280|SUPERIORITY|Daily Living Skills Domain Standard Score, Week 24|Differences in adjusted LSMean|0.18|||||TWO_SIDED|90.0|-2.87|3.22||||||||3.22|-2.87|
72499053|NCT02901431|144528286|SUPERIORITY||Difference of Adjusted LS Means|3.74|||||TWO_SIDED|90.0|0.78|6.7|||Mixed Models Analysis|||Week 12||6.70|0.78|
72499054|NCT02901431|144528286|SUPERIORITY||Difference of Adjusted LS means|2.28|||||TWO_SIDED|90.0|-0.73|5.29||||||Week 24||5.29|-0.73|
72499055|NCT02901431|144528288|SUPERIORITY||Difference in Adjusted LS Means|0.01||||0.992|TWO_SIDED|90.0|-1.99|2.01|||Mixed Models Analysis|||||2.01|-1.99|0.992
72499056|NCT03303989|144528294|SUPERIORITY|Efficacy of MMF was examined by the proportion of responders in MMF+Peg compared to PBO+Peg. Rates of the primary outcome were compared using proportions and 95% confidence intervals and tested for differences using Fisher's exact test.|||||<|0.01|TWO_SIDED|95.0|||||Fisher Exact|||Fisher's exact tests were performed to compare baseline and clinical characteristics between treatment groups as appropriate.||||<0.01
72499057|NCT01272583|144528295|SUPERIORITY_OR_OTHER|||||||1||95.0|||||ANOVA|The Friedman Test was used for ANOVA.||||||1.0
72499058|NCT01272583|144528296|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||GLP-1 intact|ANOVA|The Friedman Test was used for ANOVA||||||<0.001
72619835|NCT04223687|144770819|SUPERIORITY|||||||0.42||||||a priori threshold for statistical significance, p\<0.05|Wilcoxon (Mann-Whitney)|||||||0.42
72619836|NCT04223687|144770820|SUPERIORITY|||||||0.13||||||a priori threshold for statistical significance, p\<0.05|Wilcoxon (Mann-Whitney)|||||||0.13
72619837|NCT04223687|144770821|SUPERIORITY||||||<|0.01||||||a priori threshold for statistical significance, p\<0.05|Wilcoxon (Mann-Whitney)|||||||<0.01
72619838|NCT00425854|144770825|SUPERIORITY_OR_OTHER||Maximum Likelihood|0.048|||||TWO_SIDED|95.0|0.001|0.238|||||Maximum Likelihood estimates. The clinical benefit rate for Cohort A was calculated by relating the number of patients with CB to all treated patients in Cohort B. The CI is an exact Clopper Pearson CI.|||0.238|0.001|
72451489|NCT03868930|144424726|SUPERIORITY|||||||0.0013||||||P-value indicates significance of T-test (α=0.05) for the STEP-Home group from Baseline (T1) to Follow-Up (T3) Anger Expression Index.|t-test, 2 sided|||"Hypothesis 1: Participants randomized into the STEP-Home Intervention will show improvement on anger as measured by the State-Trait Anger Expression Inventory (STAXI).~Hypothesis 2: Treatment effects will be maintained at follow-up for both groups"||||0.0013
72451490|NCT03868930|144424726|SUPERIORITY||||||<|0.0001||||||P-value indicates significance of T-test (α=0.05) for the Present Centered Group Therapy Group from Baseline (T1) to Follow-Up (T3) Trait Anger.|t-test, 2 sided|||"Hypothesis 1: Participants randomized into the STEP-Home Intervention will show improvement on anger as measured by the State-Trait Anger Expression Inventory (STAXI).~Hypothesis 2: Treatment effects will be maintained at follow-up for both groups"||||<.0001
72451491|NCT03868930|144424726|SUPERIORITY|||||||0.0345||||||P-value indicates significance of T-test (α=0.05) for the Present Centered Group Therapy group from Baseline (T1) to Follow-Up (T3) State Anger.|t-test, 2 sided|||"Hypothesis 1: Participants randomized into the STEP-Home Intervention will show improvement on anger as measured by the State-Trait Anger Expression Inventory (STAXI).~Hypothesis 2: Treatment effects will be maintained at follow-up for both groups"||||.0345
72451492|NCT03868930|144424726|SUPERIORITY|||||||0.5918||||||P-value indicates significance of T-test (α=0.05) for the Present Centered Group Therapy group from Baseline (T1) to Follow-Up (T3) Anger Expression Index.|t-test, 2 sided|||"Hypothesis 1: Participants randomized into the STEP-Home Intervention will show improvement on anger as measured by the State-Trait Anger Expression Inventory (STAXI).~Hypothesis 2: Treatment effects will be maintained at follow-up for both groups"||||0.5918
72451493|NCT05441449|144424739|SUPERIORITY|||||||0.002|||||||ANOVA|||||||0.002
72451494|NCT05441449|144424739|SUPERIORITY||||||<|0.001|||||||ANOVA|||||||<0.001
72451495|NCT05441449|144424739|SUPERIORITY||||||<|0.001|||||||ANOVA|||||||<0.001
72451496|NCT05441449|144424740|SUPERIORITY|||||||0.043|||||||ANOVA|||||||0.043
72499059|NCT01272583|144528296|SUPERIORITY_OR_OTHER|||||||0.98||95.0||||GLP-1 Total|ANOVA|The Friedman Test was used for ANOVA.||||||0.98
72499060|NCT01272583|144528296|SUPERIORITY_OR_OTHER|||||||0.049||95.0||||GIP intact|ANOVA|The Friedman Test was used for ANOVA.||||||0.049
72499061|NCT01272583|144528296|SUPERIORITY_OR_OTHER|||||||0.44||95.0||||GIP total|ANOVA|The Friedman Test was used for ANOVA||||||0.44
72499062|NCT01272583|144528297|SUPERIORITY_OR_OTHER|||||||0.14||95.0|||||ANOVA|The Friedman Test was used for ANOVA.||||||0.14
72499063|NCT01272583|144528298|SUPERIORITY_OR_OTHER|||||||0.98||95.0|||||ANOVA|The Friedman Test was used for ANOVA.||||||0.98
72499064|NCT01272583|144528299|SUPERIORITY_OR_OTHER|||||||0.22||95.0|||||ANOVA|The Friedman Test was used for ANOVA.||||||0.22
72499065|NCT01272583|144528300|SUPERIORITY_OR_OTHER|||||||0.01||95.0|||||ANOVA|The Friedman Test was used for ANOVA.||||||0.01
72499066|NCT01272583|144528300|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Dunn's Multiple Comparison Test|Post Hoc testing||||||<0.05
72499067|NCT01272583|144528301|SUPERIORITY_OR_OTHER|||||||0.76||95.0|||||ANOVA|The Friedman Test was used for ANOVA.||||||0.76
72504709|NCT00077623|144540146|NON_INFERIORITY_OR_EQUIVALENCE|The two RO0503821 dosing schedules were compared separately to epoetin reference using ANCOVA, with Hb at BL and region as the covariates. The test for non-inferiority were based on the lower limit of the two-sided 97.5% confidence interval for the difference between the two groups. When the lower limit was greater than or equal to -0.75 g/dL, the RO0503821 groups were regarded as non-inferior to the epoetin reference group. The confidence level of 97.5% was chosen to adjust for multiplicity.|Mean Difference between groups|0.141|||<|0.0001|TWO_SIDED|97.5|-0.098|0.38||The p-value for the non-inferiority test can be derived via the t-test.|ANCOVA, CI for difference between groups|||The non-inferiority test for treatment differences in Hb change from baseline, based on ANCOVA analysis with a non-inferiority limit of -0.75 g/dL (Per Protocol Population)||0.380|-0.098|<0.0001
72619839|NCT00425854|144770830|SUPERIORITY_OR_OTHER||Clinical benefit rate|0.1|||||TWO_SIDED|95.0|0.02|0.27|||Maxium Likelihood||Maximum Likelihood estimates. The clinical benefit rate for Cohort A was calculated by relating the number of patients with CB to all treated patients in Cohort A. The confidence interval (CI) is an exact Clopper Pearson CI.|||0.27|0.02|
72451497|NCT05441449|144424740|SUPERIORITY|||||||0.281|||||||ANOVA|||||||0.281
72451498|NCT05441449|144424740|SUPERIORITY||||||<|0.001|||||||ANOVA|||||||<0.001
72451499|NCT05441449|144424741|SUPERIORITY|||||||0.352|||||||ANOVA|||||||0.352
72451500|NCT05441449|144424741|SUPERIORITY|||||||0.001|||||||ANOVA|||||||0.001
72451501|NCT05441449|144424742|SUPERIORITY|||||||0.374|||||||ANOVA|||||||0.374
72451502|NCT05441449|144424742|SUPERIORITY|||||||0.045|||||||ANOVA|||||||0.045
72451503|NCT05441449|144424742|SUPERIORITY|||||||0.196|||||||ANOVA|||||||0.196
72451504|NCT04227899|144424743|OTHER||||||<|0.0001|||||||One-sided Chi-square test|||||||<0.0001
72451505|NCT04227899|144424744|OTHER|||||||0.0019|||||||Farrington-Manning non-inferiority (NI)|||||||0.0019
72451506|NCT04227899|144424745|OTHER||||||<|0.0001|||||||Chi-squared|||||||<0.0001
72451507|NCT04227899|144424746|OTHER|||||||0.0081|||||||One-sided Chi-square test|||||||0.0081
72451508|NCT04664881|144424774|SUPERIORITY|||||||0.71|||||||Chi-squared, Corrected|||||||0.71
72451509|NCT04664881|144424775|SUPERIORITY|||||||0.99|||||||Chi-squared, Corrected|||Cardiovascular Death||||0.99
72451510|NCT04664881|144424775|SUPERIORITY|||||||0.36|||||||Chi-squared, Corrected|||Hospitalization for Myocardial Infarction||||0.36
72451511|NCT04664881|144424775|SUPERIORITY|||||||0.13|||||||Chi-squared, Corrected|||Arrhythmias||||0.13
72451512|NCT04664881|144424775|SUPERIORITY|||||||0.99|||||||Chi-squared, Corrected|||Cardiac Arrest||||0.99
72451513|NCT00357682|144424789|SUPERIORITY|5% significance level is considered statistically significant|Time Ratio|1.24||||0.068|TWO_SIDED|95.0|0.98|1.57|||Accelerated Failure Time|||Accelerated Failure Time (AFT) analysis comparing time to primary event in low dose PPI (20mg) patients to high dose PPI (80mg) patients. Included in AFT model are stratification factors (Barrett's length, age group and presence of baseline intestinal metaplasia) and aspirin randomisation group.||1.57|0.98|0.068
72451514|NCT00357682|144424789|SUPERIORITY|5% significance level is considered statistically significant|Time Ratio|1.27||||0.037|TWO_SIDED|95.0|1.01|1.58|||Accelerated Failure Time|||Accelerated Failure Time (AFT) analysis comparing time to primary event in aspirin patients to non-aspirin patients. Included in AFT model are stratification factors (Barrett's length, age group and presence of baseline intestinal metaplasia) and PPI randomisation group.||1.58|1.01|0.037
72499068|NCT00484315|144528320|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority of the TAXUS Element stent was to be accepted if the Bayesian posterior probability that the difference in 12-month TLF between TAXUS Element and TAXUS Express was \< 4.1%, given the data, was at least 95%. The sample size of 1264 subjects (resulting in 1200 after accounting for 5% attrition) was determined through simulations based on Bayesian modeling.|Median Difference (Final Values)|-0.57|STANDARD_DEVIATION|0.0155||0.9996|ONE_SIDED|95.0||1.85||The p-value is the posterior probability that the difference in 12-month TLF between TAXUS Element and TAXUS Express was \< 4.1%, given the data observed.|Bayesian modeling||Values are based on the posterior distribution of the difference in TLF rates between TAXUS Element and TAXUS Express. The upper limit is the 1-Sided 95% posterior credible interval, based off the 95th percentile of the posterior distribution.|Bayesian modeling was used to determine if the 12-month TLF rate for the TAXUS Element stent was non-inferior to the 12-month TLF rate in the TAXUS Express2 control. The null hypothesis was that the TAXUS Element TLF rate is at least 4.1% greater than the TAXUS Express TLF rate. The alternative hypothesis was that the TAXUS Element TLF rate is less than 4.1% greater than the TAXUS Express TLF rate.||1.85||0.9996
72451515|NCT00357682|144424790|SUPERIORITY|5% significance level is considered statistically significant|Time Ratio|1.36||||0.039|TWO_SIDED|95.0|1.01|1.82|||Accelerated Failure Time|||All recordings of death, regardless of the cause are used in this analysis and both PPI groups are compared.||1.82|1.01|0.039
72451516|NCT00357682|144424790|SUPERIORITY|5% significance level is considered statistically significant|Time Ratio|1.25||||0.159|TWO_SIDED|95.0|0.92|1.7|||Accelerated Failure Time|||There are 163 deaths in the aspirin comparison with all-cause mortality as the endpoint. Median follow-up is 8.9 years IQR: (8.2 , 10.0) Range: (0 , 11.5)||1.70|0.92|0.159
72499069|NCT00484315|144528321|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority of the TAXUS Element stent was to be accepted if the Bayesian posterior probability that the difference in mean ln(9-month percent diameter stenosis) between TAXUS Element and TAXUS Express was \< 0.20, given the data, was at least 95%. The sample size of 330 subjects (resulting in 280 after accounting for 15% attrition) was determined through simulations based on Bayesian modeling.|Mean Difference (Final Values)|-0.0294|STANDARD_DEVIATION|0.08253||0.997|ONE_SIDED|95.0||0.1078||P-value is posterior probability that the difference in mean ln(9-month percent diameter stenosis) between TAXUS Element and TAXUS Express was \< 0.20, given the data observed. Non-inferiority was concluded, as this probability is greater than 95%.|Bayesian modeling||Based on posterior distribution of the difference in mean ln(9-month percent diameter stenosis) between TAXUS Element and TAXUS Express. Upper limit is 1-Sided 95% posterior credible interval, based off the 95th percentile of posterior distribution.|Natural log (ln) transformation was used to improve normality of the secondary endpoint distribution. Bayesian modeling was used to determine if the mean ln(9-month percent diameter stenosis) for the TAXUS Element stent was non-inferior to the mean ln(9-month %DS) for TAXUS Express. Null hypothesis was that the TAXUS Element mean was at least 0.20 greater than the TAXUS Express mean. Alternative hypothesis was that the TAXUS Element mean is less than 0.20 greater than the TAXUS Express TLF mean.||0.1078||0.9970
72499070|NCT01552343|144528341|SUPERIORITY_OR_OTHER|||||||0.0187||95.0||||The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|||Correlation - no adjustments||||0.0187
72499071|NCT01552343|144528341|SUPERIORITY_OR_OTHER|||||||0.0094||95.0||||The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|||Partial correlation - baseline # of voids||||0.0094
72499072|NCT01552343|144528341|SUPERIORITY_OR_OTHER|||||||0.0383||95.0||||The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|||Partial correlation - baseline NI total score||||0.0383
72499073|NCT01552343|144528341|SUPERIORITY_OR_OTHER|||||||0.0133||95.0||||The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|||Partial correlation - age category||||0.0133
72499074|NCT01552343|144528341|SUPERIORITY_OR_OTHER|||||||0.0128||95.0|||||t-test, 2 sided|The a priori threshold for statistical significance was 0.05.||Partial correlation - gender||||0.0128
72499075|NCT01552343|144528342|SUPERIORITY_OR_OTHER||Mean Difference (Net)|10.7|||||TWO_SIDED|95.0|2.7|18.8|||||Non-Responders - Responders|Nocturia Impact (NI) Total Score (Q1-Q11)||18.8|2.7|
72499076|NCT01552343|144528342|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0|||||TWO_SIDED|95.0|-9.6|9.6|||||Non-Responders - Responders|Overall Impact Question (Q12)||9.6|-9.6|
72451517|NCT00357682|144424791|SUPERIORITY|5% significance level is considered statistically significant|Time Ratio|1.04||||0.864|TWO_SIDED|95.0|0.67|1.61|||Accelerated Failure Time|||There are 81 diagnoses in the PPI dose comparison with adenocarcinoma oesophageal cancer as the endpoint. Median follow-up is 8.7 years IQR: (8.1 , 9.9)||1.61|0.67|0.864
72451518|NCT00357682|144424791|SUPERIORITY|5% significance level is considered statistically significant|Time Ratio|1.02||||0.921|TWO_SIDED|95.0|0.64|1.64|||Accelerated Failure Time|||There are 70 diagnoses of adenocarcinoma in the aspirin comparison. Median follow-up is 8.8 years, IQR: (8.1 , 10), Range: (0 , 11.5)||1.64|0.64|0.921
72451519|NCT00357682|144424792|SUPERIORITY|5% significance level is considered statistically significant.|Time Ratio|1.36||||0.119|TWO_SIDED|95.0|0.92|2.02|||Accelerated Failure Time|||There are 103 such diagnoses in the PPI dose comparison. Median follow-up is 8.7 years IQR: (8.1 , 9.9) Range: (0 , 11.48)||2.02|0.92|0.119
72451520|NCT00357682|144424792|SUPERIORITY|5% significance level is considered statistically significant|Time Ratio|1.51||||0.053|TWO_SIDED|95.0|1.0|2.29|||Accelerated Failure Time|||There are a total of 92 conversions to HGD in the aspirin comparison. Median follow-up is 8.8 years IQR (8.1 , 10.0) Range (0 , 11.5)||2.29|1.00|0.053
72451521|NCT04868656|144424794|SUPERIORITY||Mean Difference (Final Values)|-2.1||||0.15|TWO_SIDED|95.0|-5.0|0.8|||Regression, Linear|||Models included the arm indicator variable in addition to the stratification variables used in randomization (site complexity level (high complexity '1a', '1b' or '1c' vs. all others); adjusted length of stay (greater than or equal to 4.7 days versus less than 4.7 days); prior implementation of STRIDE (yes vs. no).||0.8|-5.0|0.15
72622435|NCT02181413|144774849|SUPERIORITY||Hazard Ratio (HR)|1.025||||0.85|TWO_SIDED|95.0|0.789|1.332||P-value was based on log-rank test stratified by pre-induction regimen, ISS stage and response after transplantation.|Log Rank||Hazard ratio is based on an unadjusted Cox's proportional hazard regression model stratified by induction regimen, pre-induction ISS, and response after transplantation, comparing the hazard rate of Ixazomib arm over the hazard rate of Placebo arm.|||1.332|0.789|0.850
72622436|NCT02181413|144774850|SUPERIORITY||Odds Ratio (OR)|0.732||||0.37|TWO_SIDED|95.0|0.365|1.466||P-value is based on Cochran-Mantel-Haenszel (CMH) test stratified by pre-induction regimen, pre-induction international staging system (ISS), and response after transplantation at screening.|Cochran-Mantel-Haenszel||Odds ratio and CI are based on a logistic regression model with treatment group as a categorical predictor variable and pre-induction regimen, pre-induction ISS, and response after transplantation at screening as covariates.|CR||1.466|0.365|0.370
72451522|NCT04868656|144424795|SUPERIORITY||Mean Difference (Final Values)|5.3||||0.34|TWO_SIDED|95.0|-6.0|16.6|||Regression, Linear|||Models included the arm indicator variable in addition to the stratification variables used in randomization (site complexity level (high complexity '1a', '1b' or '1c' vs. all others); adjusted length of stay (greater than or equal to 4.7 days versus less than 4.7 days); prior implementation of STRIDE (yes vs. no).||16.6|-6.0|0.34
72451523|NCT04868656|144424796|SUPERIORITY||Odds Ratio (OR)|0.6||||0.23|TWO_SIDED|95.0|0.1|2.5|||Regression, Logistic|||Model includes the arm indicator variable only; model does not include stratification variables due to potential for overfitting.||2.5|0.1|0.23
72451524|NCT04955431|144424817|OTHER|We performed a 2-way Repeated Measures ANOVA to compare changes in blood IL-6 levels from baseline to post simulated firefighting on control days (Normal Sleep) and experimental days (Sleep Restriction).|||||<|0.05|||||||ANOVA|||||||<0.05
72451525|NCT04955431|144424818|OTHER|RM-ANOVA|||||>|0.05|||||||ANOVA|||||||>0.05
72451526|NCT04319887|144424834|OTHER||||||||||||||||||statistical analysis section may be deleted|||
72499077|NCT01552343|144528345|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-8.6||||0.1471|TWO_SIDED|95.0|-20.3|3.1||The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|||Nocturia Impact (NI) Total Score: Screening||3.1|-20.3|0.1471
72499078|NCT01552343|144528345|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-13.6||||0.0318|TWO_SIDED|95.0|-26.0|-1.2||The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|||Nocturia Impact (NI) Total Score: Baseline||-1.2|-26.0|0.0318
72499079|NCT01552343|144528345|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-15.8||||0.0463|TWO_SIDED|95.0|-31.2|-0.3||The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|||Overall Impact Question (Q12): Screening||-0.3|-31.2|0.0463
72499080|NCT01552343|144528345|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-17.7||||0.0413|TWO_SIDED|95.0|-34.6|-0.7||The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|||Overall Impact Question (Q12): Baseline||-0.7|-34.6|0.0413
72499081|NCT01552343|144528346|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.9647|TWO_SIDED|95.0|-6.6|6.3|||ANCOVA|Covariates baseline score, treatment and age stratum (\<65, \>=65).||Treatment effect. NI total scores are transformed to a 0-100 scale where 0 is good and 100 bad.||6.3|-6.6|0.9647
72499082|NCT00288574|144528352|SUPERIORITY|||||||0.57|||||||Chi-squared|||The proportion of patients successfully completing the trial in the fluoxetine and placebo groups was compared using the chi-squared statistic.||||0.57
72499083|NCT00288574|144528353|SUPERIORITY|||||||0.75||||||Reported p values of secondary measures were not corrected for multiple comparisons. The Bonferroni corrected level of significance is \<0.005.|Mixed Models Analysis|||Random effects regression analysis of change during treatment in body weight, in fluoxetine vs placebo groups.||||0.75
72499084|NCT00288574|144528354|SUPERIORITY|||||||0.007||||||Reported p values of secondary measures were not corrected for multiple comparisons. The Bonferroni corrected level of significance is \<0.005.|Mixed Models Analysis|||Random effects regression analysis of change during treatment of BDI in fluoxetine versus placebo groups||||0.007
72499085|NCT00288574|144528355|SUPERIORITY|||||||0.79||||||Reported p values of secondary measures were not corrected for multiple comparisons. The Bonferroni corrected level of significance is \<0.005.|Mixed Models Analysis|||Random effects regression analysis of change during treatment in BDI, in fluoxetine vs placebo groups.||||0.79
72499086|NCT00288574|144528356|SUPERIORITY|||||||0.69||||||Reported p values of secondary measures were not corrected for multiple comparisons. The Bonferroni corrected level of significance is \<0.005.|Mixed Models Analysis|||Random effects regression analysis of change during treatment in RSES, in fluoxetine vs placebo groups.||||0.69
72499087|NCT00288574|144528357|SUPERIORITY|||||||0.78||||||Reported p values of secondary measures were not corrected for multiple comparisons. The Bonferroni corrected level of significance is \<0.005.|Mixed Models Analysis|||Random effects regression analysis of change during treatment in Q-LES-Q, in fluoxetine vs placebo groups.||||0.78
72499088|NCT00288574|144528358|SUPERIORITY|||||||0.19||||||Reported p values of secondary measures were not corrected for multiple comparisons. The Bonferroni corrected level of significance is \<0.005.|Mixed Models Analysis|||Random effects regression analysis of change during treatment in Drive for Thinness subscale, in fluoxetine vs placebo groups.||||0.19
72499089|NCT00288574|144528359|SUPERIORITY|||||||0.46||||||Reported p values of secondary measures were not corrected for multiple comparisons. The Bonferroni corrected level of significance is \<0.005.|Mixed Models Analysis|||Random effects regression analysis of change during treatment in Bulimia subscale, in fluoxetine vs placebo groups.||||0.46
72451527|NCT02951052|144424841|NON_INFERIORITY|Non-inferiority in the proportion of participants with virologic failure at Week 48 (per FDA's snapshot algorithm for assessing HIV-1 RNA \>=50 copies/mL) can be concluded if the upper bound of a two-sided 95% confidence interval for the difference in failure rates between the two treatment arms (CAB - current ART) is not more than 6%.|Adjusted difference in proportion|0.6|||||TWO_SIDED|95.0|-1.2|2.5|||||Adjusted difference in proportion was based on Cochran-Mantel Haenszel stratified analysis adjusting for the following baseline stratification factors: sex at birth (Male, Female) and Baseline third agent (PI, NNRTI, INI).|||2.5|-1.2|
72451528|NCT02951052|144424842|NON_INFERIORITY|Non-inferiority in the proportion of participants with HIV-1 RNA\<50 c/mL at Week 48 (per FDA's snapshot algorithm) can be concluded if the lower bound of a two-sided 95% confidence interval for the difference in success rates between the two treatment arms (CAB - current ART) is more than -10%.|Adjusted difference in proportion|-3.0|||||TWO_SIDED|95.0|-6.7|0.7|||||Adjusted difference in proportion was based on Cochran-Mantel Haenszel stratified analysis adjusting for the following baseline stratification factors: sex at birth (Male, Female) and Baseline third agent (PI, NNRTI, INI).|||0.7|-6.7|
72619840|NCT01378273|144770835|SUPERIORITY|We assumed no effect of treatment on death, but that Epo will lead to a decrease in the rate of NDI. If we assume a multiplicative reduction in the NDI rate of 0.45 then we expect a treated NDI rate of 12 percent and an overall rate of death+NDI of 30.4% as compared to the control rate of 40.4% corresponding to an overall treatment rate ratio of 0.75. This leads to a sample size of 376 evaluated subjects per arm or a total evaluated sample size of 752 subjects.|Risk Ratio (RR)|1.03||||0.05|TWO_SIDED|0.05|0.81|1.32||A two-sided type I error of 0.05 with no formal adjustment for multiple comparisons unless otherwise specified (such as with safety outcomes).|GEE Wald test based on logistic regressi|adjustments were made for gestational age at birth and recruitment site as a fixed effect.|The numerator is the Epo group, denominator is the control group|We evaluated the primary outcome of death or neurodevelopmental impairment using generalized estimating equations to account for potential correlation within siblings from the same pregnancy, with adjustment for gestational age at birth and recruitment site as a fixed effect. The primary analysis included infants with complete data and excluded data from infants known to be alive but in whom neurodevelopmental outcomes were not assessed.||1.32|0.81|0.05
72619841|NCT01378273|144770836|OTHER|SAEs were defined prospectively. The rate of total SAEs observed through hospital discharge were compared after accounting for potential within-sibship correlation (with multiple gestations) using Generalized Estimating Equations (GEE) with robust standard errors. We used a GEE Wald test based on Poisson or logistic regression for total SAE count and individual events respectively. All other non-categorical data were assessed with GEE regression models appropriate for continuous outcomes.|Risk Ratio (RR)|1.01||||0.05|TWO_SIDED|95.0|0.83|1.22||Statistical significance was set at 0.05 for the efficacy analysis and for the final safety analysis comparing the rate of total SAEs between treatment groups, and 0.031 for death and 0.004 for the ten individual SAEs due to sequential monitoring.|Poisson regression|Adjusted for multiple gestation and gestational age|Epo is numerator and Control is denominator|We hypothesized that Epo would be safe, with no excess of SAEs compared to control infants. Sample size was based on the primary outcome, severe neurodevelopmental impairment or death.||1.22|0.83|0.05
72619842|NCT01378273|144770837|SUPERIORITY|||||||0.36||||||Statistical significance was evaluated using a Wald's test and declared significant if p \< 0.05.|Generalized estimating equation|Adjusted for gestational age at birth and treatment assignment.||For all statistical comparisons between groups, Generalized Estimating Equations (GEE) with robust standard errors and a working independence correlation structure for infants included from a multiple gestation were used. A GEE-based Wald test was used to examine differences in the global brain injury severity score between treatment groups, with adjustment for gestational age (GA) at birth used to stratify treatment randomization (24+0 to 25+6 vs. 26+0 to 27+6 in weeks+days of GA).||||0.36
72619843|NCT01378273|144770838|SUPERIORITY||||||<|0.001||||||Statistical significance was evaluated using a Wald's test and declared significant if p \< 0.007.|Generalized estimating equation|Adjusted for gestational age at birth and treatment assignment.||For statistical inference, we utilized generalized estimating equations (GEE) with robust standard errors to appropriately account for potential correlation of biomarkers for same-birth siblings. Each respective GEE model adjusted for gestational age at birth and treatment assignment as fixed factors associated with the original study design. Biomarker levels at each follow-up time point were analysed using separate GEE models. Epo levels were log-transformed in all statistical analyses.||||<0.001
72619844|NCT03907579|144770839|SUPERIORITY|||||||0.0001|||||||Wilcoxon Signed Rank Test|z= -3.861||||||0.0001
72619845|NCT03163264|144770849|SUPERIORITY||Mean Difference (Net)|0.05||||0.05|TWO_SIDED|95.0|0.0|3.45||"Statistical test was 2 sided with p\<0.05 indicating statistical significance. Note: Estimated p-value was calculated at 0.050"|Mixed Models Analysis|This analysis was in our grant and protocol paper but was added late to clinicaltrials.gov.||||3.45|0|0.050
72619846|NCT03163264|144770849|SUPERIORITY||Mean Difference (Net)|0.05||||0.05|TWO_SIDED|||||"Statistical test was 2 sided with p\<0.05 indicating statistical significance. Note: Estimated p-value was calculated at 0.05"|Wilcoxon (Mann-Whitney)|The investigators will also use repeated measures modeling based on mixed models using baseline and follow up data to adjust for characteristics||||||0.05
72619847|NCT03163264|144770850|SUPERIORITY||Mean Difference (Net)|0.069||||0.069|TWO_SIDED|95.0|-0.13|3.39||Statistical test was 2 sided with p\<0.05 indicating statistical significance.|Mixed Models Analysis|This analysis was in our grant and protocol paper but was added late to clinicaltrials.gov.||||3.39|-0.13|0.069
72451529|NCT02951052|144424916|OTHER||Adjusted difference|-0.1||||0.944|TWO_SIDED|95.0|-2.4|2.2|||ANCOVA||Treatment comparison at Week 24 for the groups CAB LA+ RPV LA and current ART is presented.|||2.2|-2.4|0.944
72619848|NCT03163264|144770850|SUPERIORITY||Mean Difference (Final Values)|1.53||||0.028|TWO_SIDED|95.0|0.21|3.76||Statistical test was 2 sided with p\<0.05 indicating statistical significance.|Wilcoxon (Mann-Whitney)|The investigators will also use repeated measures modeling based on mixed models using baseline and follow up data to adjust for characteristics||||3.76|0.21|0.028
72619849|NCT03163264|144770851|SUPERIORITY||Percent Difference|11.18||||0.033|TWO_SIDED|95.0|0.92|21.45|||Mixed Models Analysis|||||21.45|0.92|0.033
72619850|NCT03163264|144770852|SUPERIORITY||Percent Difference|11.08||||0.073|TWO_SIDED|95.0|-1.05|23.2||Statistical test was 2 sided with p\<0.05 indicating statistical significance.|Mixed Models Analysis||Adjusted|||23.2|-1.05|0.073
72451530|NCT02951052|144424916|OTHER||Adjusted difference|1.0||||0.385|TWO_SIDED|95.0|-1.3|3.4|||ANCOVA||Treatment comparison at Week 48 for the groups CAB LA+ RPV LA and current ART is presented.|||3.4|-1.3|0.385
72451531|NCT02951052|144424917|OTHER||Adjusted difference|4.9|||<|0.001|TWO_SIDED|95.0|2.8|7.1|||ANCOVA||Treatment comparison at Week 24 for the groups CAB LA+ RPV LA and current ART is presented.|||7.1|2.8|<0.001
72499090|NCT00288574|144528360|SUPERIORITY|||||||0.86||||||Reported p values of secondary measures were not corrected for multiple comparisons. The Bonferroni corrected level of significance is \<0.005.|Mixed Models Analysis|||Random effects regression analysis of change during treatment on Body Dissatisfaction subscale, in fluoxetine vs placebo groups.||||0.86
72451532|NCT02951052|144424917|OTHER||Adjusted difference|6.4|||<|0.001|TWO_SIDED|95.0|4.0|8.8|||ANCOVA||Treatment comparison at Week 48 for the groups CAB LA+ RPV LA and current ART is presented.|||8.8|4.0|<0.001
72451533|NCT02951052|144424918|OTHER||Adjusted difference|5.3||||0.008|TWO_SIDED|95.0|1.4|9.1|||ANCOVA||Treatment comparison at Week 24 for the groups CAB LA+ RPV LA and current ART is presented.|||9.1|1.4|0.008
72499091|NCT00288574|144528361|SUPERIORITY|||||||0.25||||||Reported p values of secondary measures were not corrected for multiple comparisons. The Bonferroni corrected level of significance is \<0.005.|Mixed Models Analysis|||Random effects regression analysis of change during treatment on Perfectionism subscale, in fluoxetine vs placebo groups.||||0.25
72499092|NCT00288574|144528362|SUPERIORITY|||||||0.26|||||||Mixed Models Analysis|Reported p values of secondary measures were not corrected for multiple comparisons. The Bonferroni corrected level of significance is \<0.005.||Random effects regression analysis of change during treatment on the YBC-EDS, in fluoxetine vs placebo groups.||||0.26
72499093|NCT00046228|144528363|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.91||||0.551||95.0|0.67|1.23||The null hypothesis was tested at the significance level of 0.049. If it is significant, the significance level of null hypotheses tested in the analyses 2 and 3 will be adjusted according to the modified Hochberg approach.|Log Rank|Independent Clinical Endpoints Committee confirmed components of primary endpoint except for death \& resuscitated v fib assessed by the investigator)||The null hypothesis is if reteplase/abciximab facilitated PCI is the same as the primary PCI in terms of the primary efficacy outcome. Assuming the relative risk reduction for the reteplase/abciximab facilitated PCI group versus the Primary PCI group is 15% in lower risk, 25% in medium risk, and 35% in high risk, the power of this comparison (1,000 subjects per group) is 83.4 %.||1.23|0.67|0.551
72499094|NCT00046228|144528363|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.97||||0.858||95.0|0.72|1.31|||Log Rank|||The null hypothesis is if abciximab facilitated PCI is the same as the primary PCI in terms of the primary efficacy outcome. Assuming the relative risk reduction for the Abciximab facilitated PCI versus the Primary PCI group is 12.7%, in lower risk, 17.9% in medium risk, and 25.0% in high risk, the power of this comparison (1000 subjects per group) is 54.1%||1.31|0.72|0.858
72499095|NCT00046228|144528363|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.94||||0.676||95.0|0.69|1.27|||Log Rank|||The null hypothesis is if reteplase/abciximab facilitated PCI is the same as the abciximab facilitated PCI in terms of the primary efficacy outcome. Assuming the relative risk reduction for the reteplase/abciximab facilitated PCI versus the abciximab facilitated PCI group is 2.6% in lower risk, 8.7% in medium risk, and 13.3% in high risk, the power of this comparison (1,000 subjects per group) is 13.5%.||1.27|0.69|0.676
72499096|NCT00046228|144528364|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.81||||0.247||95.0|0.57|1.16|||Chi-squared|||The null hypothesis is if reteplase/abciximab facilitated PCI is the same as the primary PCI in complications of MI within 90 days.||1.16|0.57|0.247
72499097|NCT00046228|144528364|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.82||||0.278||95.0|0.58|1.17|||Chi-squared|||The null hypothesis is if abciximab facilitated PCI is the same as the primary PCI in complications of MI within 90 days.||1.17|0.58|0.278
72499098|NCT00046228|144528364|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.99||||0.944||95.0|0.68|1.43|||Chi-squared|||The null hypothesis is if reteplase/abciximab facilitated PCI is the same as the abciximab facilitated PCI in complications of MI within 90 days.||1.43|0.68|0.944
72499099|NCT00046228|144528365|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.17||||0.494||95.0|0.74|1.84|||Chi-squared|||The null hypothesis is if retaplase/abciximab facilitated PCI is the same as the primary PCI in 90-day all cause mortality.||1.84|0.74|0.494
72499100|NCT00046228|144528365|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.25||||0.338||95.0|0.79|1.95|||Chi-squared|||The null hypothesis is if abciximab facilitated PCI is the same as the primary PCI in 90-day all cause mortality.||1.95|0.79|0.338
72499101|NCT00046228|144528365|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.94||||0.781||95.0|0.61|1.45|||Chi-squared|||The null hypothesis is if retaplase/abciximab facilitated PCI is the same as the abciximab facilitated PCI in 90-day all cause mortality.||1.45|0.61|0.781
72451534|NCT02951052|144424918|OTHER||Adjusted difference|2.0||||0.347|TWO_SIDED|95.0|-2.2|6.2|||ANCOVA||||Treatment comparison at Week 48 for the groups CAB LA+ RPV LA and current ART is presented.|6.2|-2.2|0.347
72499102|NCT00046228|144528366|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.5||||0.016||95.0|1.08|2.1|||Chi-squared|||The null hypothesis is if retaplase/abciximab facilitated PCI is the same as the primary PCI in ST-segment resolution \>70% from baseline.||2.10|1.08|0.016
72499103|NCT00046228|144528366|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.08||||0.67||95.0|0.76|1.52|||Chi-squared|||The null hypothesis is if abciximab facilitated PCI is the same as the primary PCI in ST-segment resolution \>70% from baseline.||1.52|0.76|0.670
72499104|NCT00046228|144528366|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.4||||0.042||95.0|1.01|1.93|||Chi-squared|||The null hypothesis is if retaplase/abciximab facilitated PCI is the same as the abciximab facilitated PCI in ST-segment resolution \>70% from baseline.||1.93|1.01|0.042
72499105|NCT00046228|144528367|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.9||||0.603||95.0|0.62|1.32|||Log Rank|||||1.32|0.62|0.603
72499106|NCT00046228|144528367|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.06||||0.765||95.0|0.73|1.52|||Log Rank|||||1.52|0.73|0.765
72499107|NCT00046228|144528367|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.86||||0.415||95.0|0.59|1.24|||Log Rank|||||1.24|0.59|0.415
72499108|NCT00046228|144528368|SUPERIORITY_OR_OTHER|||||||0.218||95.0|||||Fisher Exact|||The null hypothesis is if reteplase/abciximab facilitated PCI is the same as the primary PCI in the risk of ICH.||||0.218
72499109|NCT00046228|144528368|SUPERIORITY_OR_OTHER|||||||0.497||95.0|||||Fisher Exact|||The null hypothesis is if abciximab facilitated PCI is the same as the primary PCI in the risk of ICH.||||0.497
72451535|NCT02951052|144424919|OTHER||Adjusted difference|0.2||||0.344|TWO_SIDED|95.0|-0.2|0.7|||ANCOVA||Treatment comparison of SF-12 total scores at Week 24 for the groups CAB LA+ RPV LA and current ART is presented.|||0.7|-0.2|0.344
72451536|NCT02951052|144424919|OTHER||Adjusted difference|-0.1||||0.785|TWO_SIDED|95.0|-0.6|0.4|||ANCOVA||Treatment comparison of SF-12 total scores at Week 48 for the groups CAB LA+ RPV LA and current ART is presented.|||0.4|-0.6|0.785
72451537|NCT02951052|144424919|OTHER||Adjusted difference|0.676||||0.282|TWO_SIDED|95.0|-0.557|1.909|||ANCOVA||Treatment comparison of SF-12 MCS at Week 24 for the groups CAB LA+ RPV LA and current ART is presented.|||1.909|-0.557|0.282
72451538|NCT02951052|144424919|OTHER||Adjusted difference|0.635||||0.327|TWO_SIDED|95.0|-0.637|1.907|||ANCOVA||Treatment comparison of SF-12 MCS at Week 48 for the groups CAB LA+ RPV LA and current ART is presented.|||1.907|-0.637|0.327
72451539|NCT02951052|144424919|OTHER||Adjusted difference|0.697||||0.086|TWO_SIDED|95.0|-0.1|1.494|||ANCOVA||Treatment comparison of SF-12 PCS at Week 24 for the groups CAB LA+ RPV LA and current ART is presented.|||1.494|-0.100|0.086
72451540|NCT02951052|144424919|OTHER||Adjusted difference|0.696||||0.092|TWO_SIDED|95.0|-0.113|1.505|||ANCOVA||Treatment comparison of SF-12 PCS at Week 48 for the groups CAB LA+ RPV LA and current ART is presented.|||1.505|-0.113|0.092
72451541|NCT02951052|144424922|OTHER||Adjusted difference|7.9|||<|0.001|TWO_SIDED|95.0|4.1|11.7|||ANCOVA||Treatment comparison at Week 8 for the groups CAB LA+ RPV LA and current ART is presented.|||11.7|4.1|<0.001
72451542|NCT02951052|144424922|OTHER||Adjusted difference|6.9|||<|0.001|TWO_SIDED|95.0|3.3|10.4|||ANCOVA||Treatment comparison Week 24 for the groups CAB LA+ RPV LA and current ART is presented.|||10.4|3.3|<0.001
72451543|NCT02951052|144424922|OTHER||Adjusted difference|10.7|||<|0.001|TWO_SIDED|95.0|7.1|14.4|||ANCOVA||Treatment comparison at Week 48 for the groups CAB LA+ RPV LA and current ART is presented.|||14.4|7.1|<0.001
72451544|NCT01046825|144425005|SUPERIORITY|||||||0.555|||||||Log Rank|||||||0.5550
72451545|NCT01046825|144425006|SUPERIORITY|||||||0.3605|||||||Log Rank|||||||0.3605
72451546|NCT01046825|144425007|SUPERIORITY|||||||0.6181|||||||Chi-squared|||||||0.6181
72451547|NCT00624442|144425015|SUPERIORITY_OR_OTHER_LEGACY||LSM placebo corrected diff from baseline|1.0||||0.8842|TWO_SIDED|95.0|-7.0|8.0||p-value is not adjusted for multiple comparison Threshold for statistical significance: p\<0.05|ANCOVA|ANCOVA analysis is based on the following model: CFB Parameter = Bin Group + Baseline + Error, treating patients as a random effect.||Placebo corrected change from baseline least squares mean +/- the standard error of the mean||8|-7|0.8842
72451548|NCT00624442|144425015|SUPERIORITY_OR_OTHER_LEGACY||LSM placebo corrected diff from baseline|18.0|||<|0.0001|TWO_SIDED|95.0|10.0|27.0||p-value is not adjusted for multiple comparison Threshold for statistical significance: p\<0.05|ANCOVA|ANCOVA analysis is based on the following model: CFB Parameter = Bin Group + Baseline + Error, treating patients as a random effect.||Placebo corrected change from baseline least squares mean +/- the standard error of the mean||27|10|<0.0001
72451549|NCT00624442|144425015|SUPERIORITY_OR_OTHER_LEGACY||LSM placebo corrected diff from baseline|47.0|||<|0.0001||95.0|38.0|56.0||p-value is not adjusted for multiple comparison Threshold for statistical significance: p\<0.05|ANCOVA|ANCOVA analysis is based on the following model: CFB Parameter = Bin Group + Baseline + Error, treating patients as a random effect.||Placebo corrected change from baseline least squares mean +/- the standard error of the mean||56|38|<0.0001
72499110|NCT00046228|144528368|SUPERIORITY_OR_OTHER|||||||0.062||95.0|||||Fisher Exact|||The null hypothesis is if reteplase/abciximab facilitated PCI is the same as the abciximab facilitated PCI in the risk of ICH.||||0.062
72499111|NCT00046228|144528369|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.28|||<|0.001||95.0|1.63|3.19|||Fisher Exact|||The null hypothesis is if reteplase/abciximab facilitated PCI is the same as the primary PCI in the risk of non-ICH TIMI bleeding events.||3.19|1.63|<0.001
72499112|NCT00046228|144528369|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.51||||0.025||95.0|1.05|2.15|||Fisher Exact|||The null hypothesis is if abciximab facilitated PCI is the same as the primary PCI in the risk of non-ICH TIMI bleeding events.||2.15|1.05|0.025
72619851|NCT03163264|144770854|SUPERIORITY||Mean Difference (Final Values)|0.72||||0.065|TWO_SIDED|95.0|-0.05|1.48||Statistical test was 2 sided with p\<0.05 indicating statistical significance.|Mixed Models Analysis|||||1.48|-0.05|0.065
72451550|NCT00624442|144425015|SUPERIORITY_OR_OTHER_LEGACY||LSM placebo corrected diff from baseline|58.0|||<|0.0001|TWO_SIDED|95.0|46.0|70.0||p-value is not adjusted for multiple comparison Threshold for statistical significance: p\<0.05|ANCOVA|ANCOVA analysis is based on the following model: CFB Parameter = Bin Group + Baseline + Error, treating patients as a random effect.||Placebo corrected change from baseline least squares mean +/- the standard error of the mean||70|46|<0.0001
72451551|NCT00624442|144425015|SUPERIORITY_OR_OTHER_LEGACY||LSM placebo corrected diff from baseline|59.0|||<|0.0001|TWO_SIDED|95.0|47.0|72.0||p-value is not adjusted for multiple comparison Threshold for statistical significance: p\<0.05|ANCOVA|ANCOVA analysis is based on the following model: CFB Parameter = Bin Group + Baseline + Error, treating patients as a random effect.||Placebo corrected change from baseline least squares mean +/- the standard error of the mean||72|47|<0.0001
72451552|NCT00624442|144425015|SUPERIORITY_OR_OTHER_LEGACY||LSM placebo corrected diff from baseline|80.0|||<|0.0001|TWO_SIDED|95.0|71.0|89.0||p-value is not adjusted for multiple comparison Threshold for statistical significance: p\<0.05|ANCOVA|ANCOVA analysis is based on the following model: CFB Parameter = Bin Group + Baseline + Error, treating patients as a random effect.||Placebo corrected change from baseline least squares mean +/- the standard error of the mean||89|71|<0.0001
72499113|NCT00046228|144528369|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.52||||0.008||95.0|1.12|2.05|||Fisher Exact|||The null hypothesis is if reteplase/abciximab facilitated PCI is the same as the abciximab facilitated PCI in the risk of non-ICH TIMI bleeding events.||2.05|1.12|0.008
72499114|NCT00046228|144528370|SUPERIORITY_OR_OTHER|||||||0.439||95.0|||||Fisher Exact|||||||0.439
72499115|NCT00046228|144528370|SUPERIORITY_OR_OTHER|||||||0.438||95.0|||||Fisher Exact|||||||0.438
72499116|NCT00046228|144528370|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|||||||1.000
72499117|NCT00046228|144528371|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Fisher Exact|||||||<0.001
72499118|NCT00046228|144528371|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||Fisher Exact|||||||0.020
72499119|NCT00046228|144528371|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Fisher Exact|||||||<0.001
72499120|NCT00046228|144528372|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.9||||0.434||95.0|0.69|1.18|||Chi-squared|||||1.18|0.69|0.434
72451553|NCT00624442|144425015|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0||||Threshold for statistical significance: p\<0.05|ANCOVA|ANCOVA analysis based on the following model: Change from baseline = Concentration + Baseline + Error, treating patients as random effect||"All available concentration data are used in the model as a continuous variable.~p-value based on individual plasma concentration of CK-1827452 vs. corresponding systolic ejection time PD assessment (not binned based on plasma concentration)"||||<0.0001
72451554|NCT00624442|144425016|SUPERIORITY_OR_OTHER_LEGACY||LSM placebo corrected diff from baseline|1.0||||0.3665|TWO_SIDED|95.0|-1.0|2.0||p-value is not adjusted for multiple comparison Threshold for statistical significance: p\<0.05|ANCOVA|ANCOVA analysis is based on the following model: CFB Parameter = Bin Group + Baseline + Error, treating patients as a random effect.||Placebo corrected change from baseline least squares mean +/- the standard error of the mean||2|-1|0.3665
72499121|NCT00046228|144528372|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.93||||0.589||95.0|0.71|1.22|||Chi-squared|||||1.22|0.71|0.589
72499122|NCT00046228|144528372|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.97||||0.809||95.0|0.74|1.27|||Chi-squared|||||1.27|0.74|0.809
72499123|NCT01542307|144528470|SUPERIORITY_OR_OTHER|||||||0.674|||||||Wilcoxon (Mann-Whitney)|||||||0.674
72499124|NCT01542307|144528471|SUPERIORITY_OR_OTHER|||||||0.18|||||||Wilcoxon (Mann-Whitney)|||||||0.18
72499125|NCT01542307|144528472|SUPERIORITY_OR_OTHER|||||||0.38|||||||Wilcoxon (Mann-Whitney)|||||||0.38
72499126|NCT01542307|144528473|SUPERIORITY_OR_OTHER|||||||0.05|||||||Fisher Exact|||||||0.05
72499127|NCT01542307|144528474|SUPERIORITY_OR_OTHER|||||||0.05|||||||Fisher Exact|||||||0.05
72451555|NCT00624442|144425016|SUPERIORITY_OR_OTHER_LEGACY||LSM placebo corrected diff from baseline|1.0|||<|0.0357|TWO_SIDED|95.0|0.0|3.0||p-value is not adjusted for multiple comparison Threshold for statistical significance: p\<0.05|ANCOVA|ANCOVA analysis is based on the following model: CFB Parameter = Bin Group + Baseline + Error, treating patients as a random effect.||Placebo corrected change from baseline least squares mean +/- the standard error of the mean||3|0|<0.0357
72561980|NCT03653026|144654953|SUPERIORITY||Adjusted Response Rate Difference|11.3|||<|0.001|TWO_SIDED|95.0|7.2|15.3||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Cochran-Mantel-Haenszel|Adjusted for Baseline corticosteroid use (yes or no), Baseline Adapted Mayo score (≤ 7 or \> 7), and bio-IR status (bio-IR or non-bio-IR).|Difference = Upadacitinib 45 mg - Placebo|||15.3|7.2|<0.001
72619852|NCT03163264|144770855|SUPERIORITY||Mean Difference (Final Values)|0.42||||0.378|TWO_SIDED|95.0|-0.52|1.37||Statistical test was 2 sided with p\<0.05 indicating statistical significance.|Mixed Models Analysis|||||1.37|-0.52|0.378
72619853|NCT03163264|144770857|SUPERIORITY||Mean Difference (Final Values)|8.35||||0.911|TWO_SIDED|95.0|-138.25|154.95||Statistical test was 2 sided with p\<0.05 indicating statistical significance|Mixed Models Analysis|||||154.95|-138.25|0.911
72451556|NCT00624442|144425016|SUPERIORITY_OR_OTHER_LEGACY||LSM placebo corrected diff from baseline|3.0||||0.0004|TWO_SIDED|95.0|1.0|5.0||p-value is not adjusted for multiple comparison Threshold for statistical significance: p\<0.05|ANCOVA|ANCOVA analysis is based on the following model: CFB Parameter = Bin Group + Baseline + Error, treating patients as a random effect.||Placebo corrected change from baseline least squares mean +/- the standard error of the mean||5|1|0.0004
72499128|NCT01542307|144528475|SUPERIORITY_OR_OTHER|||||||0.004|||||||Fisher Exact|||||||0.004
72499129|NCT01542307|144528476|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||||||1.00
72499130|NCT01542307|144528477|SUPERIORITY_OR_OTHER|||||||0.16|||||||Fisher Exact|||||||0.16
72499131|NCT02216695|144528514|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.35|||||TWO_SIDED|95.0|1.3|1.4|||Regression, Logistic||This is OR for 65 to 74 years age group with \< 65 years as the reference group|||1.40|1.30|
72499132|NCT02216695|144528514|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.72|||||TWO_SIDED|95.0|1.66|1.79|||Regression, Logistic||This is OR for age group 75 to 84 years age group with \< 65 years as reference|||1.79|1.66|
72499133|NCT02216695|144528514|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.03|||||TWO_SIDED|95.0|1.89|2.19|||Regression, Logistic||This is OR for age group equal to greater than 85 years age group with \< 65 years as reference|||2.19|1.89|
72499134|NCT02216695|144528515|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.2|||||TWO_SIDED|95.0|1.1|1.3|||Regression, Logistic||This is the OR for 1998-2003 discharge period with 2003-08 as the reference group|||1.30|1.10|
72499135|NCT02216695|144528515|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.13|||||TWO_SIDED|95.0|1.07|1.18|||Regression, Logistic||This is the OR for 2008-13 discharge period with 2003-08 as the reference group|||1.18|1.07|
72499136|NCT01903876|144528523|NON_INFERIORITY_OR_EQUIVALENCE|equivalence||||||0.044|||||||ANCOVA|||||||.044
72499137|NCT01903876|144528524|NON_INFERIORITY_OR_EQUIVALENCE|equivalence||||||0.042|||||||ANCOVA|||||||.042
72499138|NCT02811744|144528525|EQUIVALENCE|Equivalence was defined as no significant difference between study groups on a T-test.||||||0.5||||||No adjustments on the comparison. There was no multiple comparison adjustment for the p value, as this was the primary outcome. This is the experimental p value; the threshold for significance was 0.05.|t-test, 2 sided|||No power calculation. This is an exploratory study.||||0.5
72499139|NCT03804671|144528542|OTHER|Absolute bioavailability. The statistical model was an ANOVA on the logarithmic scale including the fixed effect for 'formulation' and 'subject' as a random effect.|Ratio of the geometric means (T/R) %|70.32|||||TWO_SIDED|90.0|56.69|87.23|||||The geometric coefficient of variation (gCV) = 18.7. Ratio was calculated as (AUC0-∞/dose) oral /(AUC0-∞/dose) intravenous multiplied by 100.|||87.23|56.69|
72499140|NCT03902080|144528543|SUPERIORITY||Least square mean difference|-0.74|STANDARD_ERROR_OF_MEAN|0.142|<|0.0001|TWO_SIDED|95.0|-1.02|-0.46|||Mixed Models Analysis|||||-0.46|-1.02|<0.0001
72499141|NCT03902080|144528544|SUPERIORITY||Least Squares Means Difference|-0.95|STANDARD_ERROR_OF_MEAN|0.211|<|0.0001|TWO_SIDED|95.0|-1.37|-0.54|||Mixed Models Analysis|||||-0.54|-1.37|<0.0001
72499142|NCT03902080|144528545|SUPERIORITY||Least Squares Means Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.07|=|0.0015|TWO_SIDED|95.0|-0.36|-0.09|||Mixed Models Analysis|||||-0.09|-0.36|=0.0015
72619854|NCT03163264|144770858|SUPERIORITY||Mean Difference (Final Values)|32.83||||0.648|TWO_SIDED|95.0|-108.15|173.81||Statistical test was 2 sided with p\<0.05 indicating statistical significance.|Mixed Models Analysis|||||173.81|-108.15|0.648
72619855|NCT03163264|144770859|SUPERIORITY||Percent Difference|10.32||||0.736|TWO_SIDED|95.0|-49.73|70.37||Statistical test was 2 sided with p\<0.05 indicating statistical significance|Mixed Models Analysis|||||70.37|-49.73|0.736
72451557|NCT00624442|144425016|SUPERIORITY_OR_OTHER_LEGACY||LSM placebo corrected diff from baseline|3.0||||0.0086|TWO_SIDED|95.0|1.0|4.0||p-value is not adjusted for multiple comparison Threshold for statistical significance: p\<0.05|ANCOVA|ANCOVA analysis is based on the following model: CFB Parameter = Bin Group + Baseline + Error, treating patients as a random effect.||Placebo corrected change from baseline least squares mean +/- the standard error of the mean||4|1|0.0086
72451558|NCT00624442|144425016|SUPERIORITY_OR_OTHER_LEGACY||LSM placebo corrected diff from baseline|2.0||||0.032|TWO_SIDED|95.0|0.0|5.0||p-value is not adjusted for multiple comparison Threshold for statistical significance: p\<0.05|ANCOVA|ANCOVA analysis is based on the following model: CFB Parameter = Bin Group + Baseline + Error, treating patients as a random effect.||Placebo corrected change from baseline least squares mean +/- the standard error of the mean||5|0|0.032
72561981|NCT03653026|144654954|SUPERIORITY||LS Mean Difference|6.0|STANDARD_ERROR_OF_MEAN|0.9|<|0.001|TWO_SIDED|95.0|4.19|7.73||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Mixed-effect model repeated measurement|MMRM with Baseline, treatment, visit, treatment-by-visit interaction, and strata (Baseline Adapted Mayo score, corticosteroid use, and bio-IR status).|Difference = Upadacitinib 45 mg - Placebo|||7.73|4.19|<0.001
72451559|NCT00624442|144425016|SUPERIORITY_OR_OTHER_LEGACY||LSM placebo corrected diff from baseline|5.0|||<|0.0001|TWO_SIDED|95.0|3.0|6.0||p-value is not adjusted for multiple comparison Threshold for statistical significance: p\<0.05|ANCOVA|ANCOVA analysis is based on the following model: CFB Parameter = Bin Group + Baseline + Error, treating patients as a random effect.||Placebo corrected change from baseline least squares mean +/- the standard error of the mean||6|3|<0.0001
72451560|NCT00624442|144425016|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0||||Threshold for statistical significance: p\<0.05|ANCOVA|ANCOVA analysis based on the following model: Change from baseline = Concentration + Baseline + Error, treating patients as random effect||"All available concentration data are used in the model as a continuous variable.~p-value based on individual plasma concentration of CK-1827452 vs. corresponding fractional shortening PD assessment (not binned based on plasma concentration)"||||<0.0001
72451561|NCT00003222|144425038|SUPERIORITY_OR_OTHER|||||||0.13||95.0|||||Chi-squared|||This is a test for differences between the response rates of the two arms. The null hypothesis is that the arms have equal response rates and the alternative hypothesis is that they are different.||||0.13
72451562|NCT00003222|144425039|SUPERIORITY_OR_OTHER|||||||0.004||95.0|||||Chi-squared|||This is a test for differences between the response rates of the two arms. The null hypothesis is that the arms have equal response rates and the alternative hypothesis is that they are different.||||0.004
72499143|NCT03902080|144528546|SUPERIORITY||Least Squares Means Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.269|=|0.0034|TWO_SIDED|95.0|-1.33|-0.27|||Mixed Models Analysis|||||-0.27|-1.33|=0.0034
72499144|NCT03902080|144528547|SUPERIORITY||Least Squares Means Difference|-0.9|STANDARD_ERROR_OF_MEAN|0.17|<|0.0001|TWO_SIDED|95.0|-1.2|-0.5|||Mixed Models Analysis|||||-0.5|-1.2|<0.0001
72499145|NCT03902080|144528548|SUPERIORITY||Least Squares Means Difference|15.07|STANDARD_ERROR_OF_MEAN|3.03|<|0.0001|TWO_SIDED|95.0|9.13|21.02|||Mixed Models Analysis|||||21.02|9.13|<0.0001
72499146|NCT00004054|144528606|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.04||||0.81|TWO_SIDED|95.0|0.76|1.43|||Log Rank|||The original target sample size was 1440 patients with a requirement of 340 deaths to test the hypothesis of overall survival (OS) efficacy of the hormones and RT plus chemotherapy arm; the design is based on detecting a 6% absolute improvement in 5-year OS from 79% to 85%, or a 33% relative reduction in the yearly hazard rate, with 90% power and a 2-sided significance level of 0.05.||1.43|0.76|0.81
72451563|NCT04757753|144425040|NON_INFERIORITY|"πN = 2-year successful treatment rate of PA1704 πR = 2-year successful treatment rate of BioRoot™ RCS Δ = πN - πR ΔL = non-inferiority margin fixed to 13% or 0.13~Hypotheses are :~H0 : Δ ≤ -ΔL H1 : Δ \> -ΔL The χ2 of Dunnett \& Gent is used to assess the non-inferiority"|Mean Difference (Final Values)|0.006||||0.03|TWO_SIDED|90.0|-0.0074|0.0087||A priori threshold for statistical significance was \< 0.05|Chi-squared, Corrected|||The statistical analysis was done on the proportion difference of the treatment efficacy, defined on loose criteria, at 24 months, in PP population.||0.0087|-0.0074|0.03
72451564|NCT04079517|144425207|NON_INFERIORITY|Comparing mean difference in symptom score (95% confidence intervals). Post hoc analysis. Not powered, but to give an indication of differences between standard dose (20mg) and the non-approved dose (10mg).|Mean Difference (Final Values)|1.9|||||TWO_SIDED|95.0|||||||Post hoc analysis. Not powered, but to give an indication on differences in symptom score between standard dose (20mg) and the non-approved dose (10mg).||Post hoc analysis. Not powered, but to give an indication on differences between standard dose (20mg) and the non-approved dose (10mg).|||
72451565|NCT04518943|144425239|SUPERIORITY||Mean Difference (Net)|-634.0||||0.418|TWO_SIDED|90.0|-1924.0|655.0|||linear mixed model|||This is the results of financial vs non-financial reward factor at week 12. It compares change in steps from baseline to week 12 between subjects randomized to receive financial rewards compared to those who received nonfinancial rewards. A linear mixed-effect model was estimated with independent variables of demographics, steps and outcomes at baseline, indicators for each of the four factor assignment, linear week with a spline at week 12, and interactions between factors and weeks.||655|-1924|0.418
72499147|NCT00004054|144528607|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.82|TWO_SIDED|95.0|0.74|1.27|||Gray's test|2-sided significance level of 0.05|Fine-Gray regression model was used to obtain the hazard ratio. Reference level = Hormones and RT.|||1.27|0.74|0.82
72499148|NCT00004054|144528608|SUPERIORITY||Hazard Ratio (HR)|0.56||||0.09|TWO_SIDED|95.0|0.28|1.1|||Gray's test|2-sided significance level = 0.05|Fine-Gray regression model was used to obtain the hazard ratio. Reference level = Hormones and RT.|||1.10|0.28|0.09
72499149|NCT00004054|144528609|SUPERIORITY||Hazard Ratio (HR)|0.81||||0.42|TWO_SIDED|95.0|0.48|1.36|||Gray's test|2-sided significance level = 0.05|Fine-Gray regression model was used to obtain the hazard ratio. Reference level = Hormones and RT.|||1.36|0.48|0.42
72499150|NCT00004054|144528610|SUPERIORITY||Hazard Ratio (HR)|0.94||||0.61|TWO_SIDED|95.0|0.75|1.19|||Log Rank|2-sided significance level = 0.05|Cox proportional hazards model was used to obtain the hazard ratio. Reference level = Hormones and RT.|||1.19|0.75|0.61
72499151|NCT01053312|144528640|NON_INFERIORITY_OR_EQUIVALENCE|The level of association between SUVR and the amyloid levels was analyzed using a regression model.|R²|0.688||||0.098|TWO_SIDED||||||Regression, Linear|||Contralateral to the biopsy Site||||0.098
72451566|NCT04518943|144425239|SUPERIORITY||Mean Difference (Net)|-1697.0||||0.033|TWO_SIDED|90.0|-3000.0|-385.0|||Mixed Models Analysis||Positive values represent a positive effect of lottery based rewards compared to loss-based rewards.|This is the results of lottery vs loss-framed reward factor at week 12. It compares change in steps from baseline to week 12 between subjects randomized to receive financial rewards compared to those who received nonfinancial rewards. A linear mixed-effect model was estimated with independent variables of demographics, steps and outcomes at baseline, indicators for each of the four factor assignments, linear week with a spline at week 12, and interactions between factors and weeks.||-385|-3000|0.033
72451567|NCT04518943|144425239|SUPERIORITY||Mean Difference (Net)|820.0||||0.248|TWO_SIDED|90.0|-347.0|1988.0|||Mixed Models Analysis|||This is the results of precommitment (PC) vs no PC factor at week 12. It compares change in steps from baseline to week 12 between subjects randomized to receive a request for PC compared to those who received no request. A linear mixed-effect model was estimated with independent variables of demographics, steps and outcomes at baseline, indicators for each of the four factor assignments, linear week with a spline at week 12, and interactions between factors and weeks.||1988|-347|0.248
72451568|NCT04518943|144425239|SUPERIORITY||Mean Difference (Net)|1121.0||||0.125|TWO_SIDED|90.0|82.0|2323.0|||Mixed Models Analysis|||This is the results of advice vs no advice factor at week 12. It compares change in steps from baseline to week 12 between subjects randomized to receive a request for advice to other subjects compared to those who received no request. A linear mixed-effect model was estimated with independent variables of demographics, steps and outcomes at baseline, indicators for each of the four factor assignments, linear week with a spline at week 12, and interactions between factors and weeks.|Positive values represent a positive effect of requests for advice on steps compared to no request for advice.|2323|82|0.125
72451569|NCT04518943|144425240|SUPERIORITY||Mean Difference (Net)|-0.18|STANDARD_ERROR_OF_MEAN|0.53||0.739|TWO_SIDED|90.0|-1.05|0.7|||Regression, Linear|||This is the results of financial vs non-financial reward factor at week 12. It compares change in efficacy from baseline to week 12 between subjects randomized to receive financial rewards compared to those who received nonfinancial rewards. A linear model was estimated with independent variables of demographics, steps and survey-based outcomes at baseline, indicators for each of the four factor assignments, indicator for week 12 or 24 week, and interactions between factors and week indicator.|Positive values represent a positive effect of financial rewards compared to non-financial rewards.|0.70|-1.05|0.739
72451570|NCT04518943|144425240|SUPERIORITY||Mean Difference (Net)|-0.51||||0.347|TWO_SIDED|90.0|-1.42|0.39|||Mixed Models Analysis||Positive values represent a positive effect of financial rewards compared to non-financial rewards.|This is the results of financial vs non-financial reward factor at week 24. It compares change in efficacy from baseline to week 24 between subjects randomized to receive financial rewards compared to those who received nonfinancial rewards. A linear model was estimated with independent variables of demographics, steps and survey-based outcomes at baseline, indicators for each of the four factor assignments, indicator for week 12 or 24 week, and interactions between factors and week indicator.||0.39|-1.42|0.347
72451571|NCT04518943|144425240|SUPERIORITY||Mean Difference (Net)|0.61||||0.293|TWO_SIDED|90.0|-0.35|1.57|||Mixed Models Analysis||Positive values represent a positive effect of lottery-based rewards compared to loss-based rewards.|This is the results of lottery vs loss-framed reward factor at week 12. It compares change in efficacy from baseline to week 12 between subjects randomized to receive lottery-based rewards compared to those who received loss-based rewards. A linear model was estimated with independent variables of demographics, steps and survey-based outcomes at baseline, indicators for each of the four factor assignments, indicator for week 12 or 24 week, and interactions between factors and week indicator.||1.57|-0.35|0.293
72451572|NCT04518943|144425240|SUPERIORITY||Mean Difference (Net)|0.31||||0.599|TWO_SIDED|90.0|-0.67|1.3|||Mixed Models Analysis||Positive values represent a positive effect of lottery-based rewards compared to loss-based rewards.|This is the results of lottery vs loss-framed reward factor at week 24. It compares efficacy at week 24 between subjects randomized to receive lottery-based rewards compared to those who received loss-based rewards. A linear model was estimated with independent variables of demographics, steps and survey-based outcomes at baseline, indicators for each of the four factor assignments, indicator for week 12 or 24 week, and interactions between factors and week indicator.||1.30|-0.67|0.599
72561982|NCT01729026|144655003|SUPERIORITY_OR_OTHER_LEGACY||Effect size (Cohen's d)|-0.75||||0.141|TWO_SIDED|95.0|-1.85|0.35||Between baseline and 3-month follow-up, subjects in the Adoption group had a mean improvement of 15.20 points on the PCL-5 compared to 7.77 points in the Wait-list group.|Mixed effects regression models|||The analyses were mixed effect regression models with repeated measures at randomization (baseline) and at the 3-month post-randomization follow-up using a 2 x 2 design. Treatment (Adoption group vs Wait-list group), time (baseline and 3-month follow-up) and their interaction were the fixed design effects. The treatment by time interaction tests the significance of the difference between baseline and 3-month follow-up between the Adoption and Wait-list groups.||0.35|-1.85|0.141
72451573|NCT04518943|144425240|SUPERIORITY||Mean Difference (Net)|1.49||||0.007|TWO_SIDED|90.0|0.58|2.4|||Regression, Linear|||This is the results of precommitment (PC) vs no PC factor at week 12. It compares efficacy at week 12 between subjects randomized to receive a request for PC to other subjects compared to those who received no request. A linear model was estimated with independent variables of demographics, steps and survey-based outcomes at baseline, indicators for each of the four factor assignments, indicator for week 12 or 24 week, and interactions between factors and week indicator.||2.40|0.58|0.007
72451574|NCT04518943|144425240|SUPERIORITY||Mean Difference (Net)|1.78||||0.002|TWO_SIDED|90.0|0.86|2.7|||Regression, Linear|||This is the results of precommitment (PC) vs no PC factor at week 24. It compares efficacy at week 24 between subjects randomized to receive a request for PC compared to those who received no request. A linear model was estimated with independent variables of demographics, steps and survey-based outcomes at baseline, indicators for each of the four factor assignments, indicator for week 12 or 24 week, and interactions between factors and week indicator.||2.70|0.86|0.002
72499152|NCT01053312|144528640|NON_INFERIORITY_OR_EQUIVALENCE|The level of association between SUVR and the amyloid levels was analyzed using a regression model.|R²|0.482||||0.268|||||||Regression, Linear|||Ipsilateral to the biopsy Site||||0.268
72619856|NCT03163264|144770860|SUPERIORITY||Percent Difference|19.36||||0.53|TWO_SIDED|95.0|-41.09|79.8||Statistical test was 2 sided with p\<0.05 indicating statistical significance.|Mixed Models Analysis|||||79.8|-41.09|0.53
72451575|NCT04518943|144425240|SUPERIORITY||Mean Difference (Net)|1.02||||0.068|TWO_SIDED|90.0|0.1|1.94|||Regression, Linear|||This is the results of advice vs no-advice factor at week 12. It compares efficacy at week 12 between subjects randomized to receive a request for advice to other subjects compared to those who received no request. A linear model was estimated with independent variables of demographics, steps and survey-based outcomes at baseline, indicators for each of the four factor assignments, indicator for week 12 or 24 week, and interactions between factors and week indicator.||1.94|0.10|0.068
72451576|NCT04518943|144425240|SUPERIORITY||Mean Difference (Net)|0.19||||0.74|TWO_SIDED|90.0|-0.76|1.14|||Regression, Linear|||This is the results of advice vs no-advice factor at week 24. It compares efficacy at week 24 between subjects randomized to receive a request for advice to other subjects compared to those who received no request. A linear model was estimated with independent variables of demographics, steps and survey-based outcomes at baseline, indicators for each of the four factor assignments, indicator for week 12 or 24 week, and interactions between factors and week indicator.||1.14|-0.76|0.740
72451577|NCT04518943|144425241|SUPERIORITY||Mean Difference (Net)|0.14||||0.481|TWO_SIDED|90.0|-0.19|0.47|||Regression, Linear|||This is the results of financial vs non-financial reward factor at week 12. It compares intrinsic motivation in week 12 between subjects randomized to receive financial rewards compared to those who received nonfinancial rewards. A linear model was estimated with independent variables of demographics, steps and survey-based outcomes at baseline, indicators for each of the four factor assignments, indicator for week 12 or 24 week, and interactions between factors and week indicator..||0.47|-0.19|0.481
72451578|NCT04518943|144425241|SUPERIORITY||Mean Difference (Net)|0.18||||0.388|TWO_SIDED|90.0|-0.16|0.52|||Regression, Linear|||This is the results of financial vs non-financial reward factor at week 24. It compares intrinsic motivation in week 24 between subjects randomized to receive financial rewards compared to those who received nonfinancial rewards. A linear model was estimated with independent variables of demographics, steps and survey-based outcomes at baseline, indicators for each of the four factor assignments, indicator for week 12 or 24 week, and interactions between factors and week indicator.||0.52|-0.16|0.388
72451579|NCT04518943|144425241|SUPERIORITY||Mean Difference (Net)|-0.02||||0.926|TWO_SIDED|90.0|-0.38|0.34|||Regression, Linear|||This is the results of lottery vs loss-framed reward factor at week 12. It compares intrinsic motivation at week 12 between subjects randomized to receive lottery-based rewards compared to those who received loss-based rewards. A linear model was estimated with independent variables of demographics, steps and survey-based outcomes at baseline, indicators for each of the four factor assignments, indicator for week 12 or 24 week, and interactions between factors and week indicator.||0.34|-0.38|0.926
72451580|NCT04518943|144425241|SUPERIORITY||Mean Difference (Net)|-0.17||||0.446|TWO_SIDED|90.0|-0.54|0.2|||Regression, Linear|||This is the results of lottery vs loss-framed reward factor at week 24. It compares intrinsic motivation at week 24 between subjects randomized to receive lottery-based rewards compared to those who received loss-based rewards. A linear model was estimated with independent variables of demographics, steps and survey-based outcomes at baseline, indicators for each of the four factor assignments, indicator for week 12 or 24 week, and interactions between factors and week indicator.||0.20|-0.54|0.446
72451581|NCT04518943|144425241|SUPERIORITY||Mean Difference (Net)|0.08||||0.711|TWO_SIDED|90.0|-0.27|0.42|||Regression, Linear|||This is the results of precommitment (PC) vs no PC factor at week 12. It compares intrinsic motivation at week 12 between subjects randomized to receive a request for PC to compared to those who received no request. A linear model was estimated with independent variables of demographics, steps and survey-based outcomes at baseline, indicators for each of the four factor assignments, indicator for week 12 or 24 week, and interactions between factors and week indicator.||0.42|-0.27|0.711
72451582|NCT04518943|144425241|SUPERIORITY||Mean Difference (Net)|-0.2||||0.345|TWO_SIDED|90.0|-0.55|0.15|||Regression, Linear|||This is the results of precommitment (PC) vs no PC factor at week 24. It compares efficacy at week 24 between subjects randomized to receive a request for PC to compared to those who received no request. A linear model was estimated with independent variables of demographics, steps and survey-based outcomes at baseline, indicators for each of the four factor assignments, indicator for week 12 or 24 week, and interactions between factors and week indicator.||0.15|-0.55|0.345
72451583|NCT04518943|144425241|SUPERIORITY||Mean Difference (Net)|0.02||||0.928|TWO_SIDED|90.0|-0.33|0.36|||Regression, Linear|||This is the results of advice vs no-advice factor at week 12. It compares intrinsic motivation at week 12 between subjects randomized to receive a request for advice compared to those who received no request. A linear model was estimated with independent variables of demographics, steps and survey-based outcomes at baseline, indicators for each of the four factor assignments, indicator for week 12 or 24 week, and interactions between factors and week indicator.||0.36|-0.33|0.928
72451584|NCT04518943|144425241|SUPERIORITY||Mean Difference (Net)|-0.19||||0.372|TWO_SIDED|90.0|-0.55|0.16|||Regression, Linear|||This is the results of advice vs no-advice factor at week 24. It compares intrinsic motivation at week 24 between subjects randomized to receive a request for advice to other subjects compared to those who received no request. A linear model was estimated with independent variables of demographics, steps and survey-based outcomes at baseline, indicators for each of the four factor assignments, indicator for week 12 or 24 week, and interactions between factors and week indicator.||0.16|-0.55|0.372
72499153|NCT01053312|144528640|NON_INFERIORITY_OR_EQUIVALENCE|The level of association between SUVR and the amyloid levels was analyzed using a regression model.|R²|0.685||||0.099|||||||Regression, Linear|||Composite Region||||0.099
72499154|NCT00619957|144528681|SUPERIORITY_OR_OTHER||Least Square (LS) Mean Difference|4.53|||<|0.0001|TWO_SIDED|95.0|3.46|5.6|||ANOVA|Fixed effects for treatment and pooled center.||A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.||5.60|3.46|<0.0001
72504805|NCT03114969|144540516|SUPERIORITY||Odds Ratio (OR)|3.483||||0.02|TWO_SIDED|95.0|1.218|9.961||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.|||9.961|1.218|0.020
72451585|NCT04518943|144425242|SUPERIORITY||Mean Difference (Net)|0.35||||0.767|TWO_SIDED|90.0|-1.6|2.3|||Regression, Linear|||This is the results of financial vs non-financial reward factor at week 12. It compares phq8 mental health scores in week 12 between subjects randomized to receive financial rewards compared to those who received nonfinancial rewards. A linear model was estimated with independent variables of demographics, steps and outcomes at baseline, indicators for each of the four factor assignments, indicator for week 12 or 24 week, and interactions between factors and week indicator.||2.3|-1.60|0.767
72619857|NCT05259722|144770861|SUPERIORITY||Mean Difference (Net)|-16.1|||<|0.001|TWO_SIDED|95.0|-23.28|-8.86|||ANCOVA|||The change from baseline was analysed using an ANCOVA model with effects of treatment group, hyperkeratotic/non-hyperkeratotic subtype and baseline value of the score. Missing data was imputed with WOCF. Data after initiation of rescue treatment or permanent discontinuation of IMP was treated as missing.||-8.86|-23.28|<0.001
72619858|NCT05259722|144770862|SUPERIORITY||Risk Difference (RD)|12.6|||=|0.003|TWO_SIDED|95.0|4.34|20.78|||Cochran-Mantel-Haenszel|||The difference in response rates was analysed using the Cochran-Mantel-Haenszel test stratified by hyperkeratotic/non-hyperkeratotic subtype. Missing data was imputed as non-response. Data after initiation of rescue treatment or permanent discontinuation of IMP was treated as missing.||20.78|4.34|=0.003
72619859|NCT05259722|144770863|SUPERIORITY||Risk Difference (RD)|10.6|||=|0.004|TWO_SIDED|95.0|3.31|17.87|||Cochran-Mantel-Haenszel|||The difference in response rates was analysed using the Cochran-Mantel-Haenszel test stratified by hyperkeratotic/non-hyperkeratotic subtype. Missing data was imputed as non-response. Data after initiation of rescue treatment or permanent discontinuation of IMP was treated as missing.||17.87|3.31|=0.004
72619860|NCT05259722|144770864|SUPERIORITY||Mean Difference (Net)|-0.7|||=|0.005|TWO_SIDED|95.0|-1.12|-0.2|||ANCOVA|||The change from baseline was analysed using an ANCOVA model with effects of treatment group, hyperkeratotic/non-hyperkeratotic subtype and baseline value of the score. Missing data was imputed with WOCF. Data after initiation of rescue treatment or permanent discontinuation of IMP was treated as missing.||-0.20|-1.12|=0.005
72619861|NCT05259722|144770865|SUPERIORITY||Mean Difference (Net)|-0.6|||=|0.018|TWO_SIDED|95.0|-1.08|-0.1|||ANCOVA|||The change from baseline was analysed using an ANCOVA model with effects of treatment group, hyperkeratotic/non-hyperkeratotic subtype and baseline value of the score. Missing data was imputed with WOCF. Data after initiation of rescue treatment or permanent discontinuation of IMP was treated as missing.||-0.10|-1.08|=0.018
72619862|NCT05259722|144770866|SUPERIORITY||Mean Difference (Net)|14.3|||<|0.001|TWO_SIDED|95.0|5.81|22.86|||ANCOVA|||The AUC was analysed using a robust ANCOVA model with effects of treatment group, hyperkeratotic/non-hyperkeratotic subtype and baseline value of the score. Missing data was imputed as non-response. Data after initiation of rescue treatment or permanent discontinuation of IMP was treated as missing.||22.86|5.81|<0.001
72451586|NCT04518943|144425242|SUPERIORITY||Mean Difference (Net)|0.78||||0.5|TWO_SIDED|90.0|-1.12|2.69|||Regression, Linear|||This is the results of financial vs non-financial reward factor at week 24. It compares phq8 mental health scores in week 24 between subjects randomized to receive financial rewards compared to those who received nonfinancial rewards. A linear model was estimated with independent variables of demographics, steps and outcomes at baseline, indicators for each of the four factor assignments, indicator for week 12 or 24 week, and interactions between factors and week indicator.||2.69|-1.12|0.500
72451587|NCT04518943|144425242|SUPERIORITY||Mean Difference (Net)|0.59||||0.631|TWO_SIDED|90.0|-1.43|2.61|||Regression, Linear|||This is the results of lottery vs loss-framed reward factor at week 12. It compares phq8 mental health scores at week 12 between subjects randomized to receive lottery-based rewards compared to those who received loss-based rewards. A linear model was estimated with independent variables of demographics, steps and outcomes at baseline, indicators for each of the four factor assignments, indicator for week 12 or 24, and interactions between factors and weeks.||2.61|-1.43|0.631
72499155|NCT00619957|144528682|SUPERIORITY_OR_OTHER||LS Mean Difference|2.56|||<|0.0001|TWO_SIDED|95.0|1.66|3.47|||ANOVA|Fixed effects for treatment and pooled center.||A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.||3.47|1.66|<0.0001
72451588|NCT04518943|144425242|SUPERIORITY||Mean Difference (Net)|-0.62||||0.62|TWO_SIDED|90.0|-2.69|1.44|||Regression, Linear|||This is the results of lottery vs loss-framed reward factor at week 24. It compares phq8 mental health scores at week 24 between subjects randomized to receive lottery-based rewards compared to those who received loss-based rewards. A linear model was estimated with independent variables of demographics, steps and outcomes at baseline, indicators for each of the four factor assignments, indicator for week 12 or 24, and interactions between factors and weeks.||1.44|-2.69|0.620
72451589|NCT04518943|144425242|SUPERIORITY||Mean Difference (Net)|0.17||||0.886|TWO_SIDED|90.0|-1.77|2.12|||Regression, Linear|||This is the results of pre-commitment (PC) vs no PC factor at week 12. It compares phq8 mental health scores at week 12 between subjects randomized to receive a request for PC to compared to those who received no request. A linear model was estimated with independent variables of demographics, steps and outcomes at baseline, indicators for each of the four factor assignments, indicator for week 12 or 24 week, and interactions between factors and week indicator.||2.12|-1.77|0.886
72451590|NCT04518943|144425242|SUPERIORITY||Mean Difference (Net)|-0.07||||0.95|TWO_SIDED|-2.03|-2.03|1.88|||Regression, Linear|||This is the results of precommitment (PC) vs no PC factor at week 24. It compares phq8 mental health scores at week 24 between subjects randomized to receive a request for PC to compared to those who received no request. A linear model was estimated with independent variables of demographics, steps and outcomes at baseline, indicators for each of the four factor assignments, indicator for week 12 or 24 week, and interactions between factors and week indicator.||1.88|-2.03|0.950
72451591|NCT04518943|144425242|SUPERIORITY||Mean Difference (Net)|-1.45||||0.248|TWO_SIDED|90.0|-3.51|0.61|||Regression, Linear|||This is the results of advice vs no-advice factor at week 12. It compares phq mental health scores at week 12 between subjects randomized to receive a request for advice to other subjects compared to those who received no request. A linear model was estimated with independent variables of demographics, steps and outcomes at baseline, indicators for each of the four factor assignments, indicator for week 12 or 24 week, and interactions between factors and week indicator.||0.61|-3.51|0.248
72451592|NCT04518943|144425242|SUPERIORITY||Mean Difference (Net)|-1.23||||0.317|TWO_SIDED|90.0|-3.25|0.79|||Regression, Linear|||This is the results of advice vs no-advice factor at week 24. It compares phq mental health scores at week 24 between subjects randomized to receive a request for advice to other subjects compared to those who received no request. A linear model was estimated with independent variables of demographics, steps and outcomes at baseline, indicators for each of the four factor assignments, indicator for week 12 or 24 week, and interactions between factors and week indicator.||0.79|-3.25|0.317
72451593|NCT04518943|144425243|SUPERIORITY||Mean Difference (Net)|-35.0||||0.972|TWO_SIDED|90.0|-1685.0|1616.0|||Mixed Models Analysis|||This is the results of financial vs non-financial reward factor at week 24. It compares change in steps from baseline to week 24 between subjects randomized to receive financial rewards compared to those who received nonfinancial rewards. A linear mixed-effect model was estimated with independent variables of demographics, steps and outcomes at baseline, indicators for each of the four factor assignments, linear week with a spline at week 12, and interactions between factors and weeks.||1616|-1685|0.972
72451594|NCT04518943|144425243|SUPERIORITY||Mean Difference (Net)|-2428.0||||0.019|TWO_SIDED|90.0|-4134.0|-722.0|||Mixed Models Analysis||Positive values represent a positive effect of lottery-based rewards compared to loss-based rewards.|This is the results of lottery vs loss-framed reward factor at week 24. It compares change in steps from baseline to week 24 between subjects randomized to receive lottery-based rewards compared to those who received loss-based rewards. A linear mixed-effect model was estimated with independent variables of demographics, steps and outcomes at baseline, indicators for each of the four factor assignments, linear week with a spline at week 12, and interactions between factors and weeks.||-722|-4134|0.019
72451595|NCT04518943|144425243|SUPERIORITY||Mean Difference (Net)|418.0||||0.627|TWO_SIDED|90.0|-999.0|1836.0|||Mixed Models Analysis|||This is the results of precommitment (PC) vs no PC factor at week 24. It compares change in steps from baseline to week 24 between subjects randomized to receive a request for PC compared to those who received no request. A linear mixed-effect model was estimated with independent variables of demographics, steps and outcomes at baseline, indicators for each of the four factor assignments, linear week with a spline at week 12, and interactions between factors and weeks.||1836|-999|0.627
72451596|NCT04518943|144425243|SUPERIORITY||Mean Difference (Net)|195.0||||0.842|TWO_SIDED|90.0|-1417.0|1807.0|||Mixed Models Analysis|||This is the results of advice vs no advice factor at week 24. It compares change in steps from baseline to week 24 between subjects randomized to receive a request for advice to other subjects compared to those who received no request. A linear mixed-effect model was estimated with independent variables of demographics, steps and outcomes at baseline, indicators for each of the four factor assignments, linear week with a spline at week 12, and interactions between factors and weeks.||1807|-1417|0.842
72451597|NCT02701283|144425434|NON_INFERIORITY|Absolute non-inferiority margin was 0.06|Posterior Median of the Difference|0.999|||||TWO_SIDED|95.0||||The posterior probability of non-inferiority is \> 0.999. The posterior probability is the probability of the event rate by updating the prior probability distribution with observed data at the interim analysis using Bayes' Theorem.|Bayesian||95% Bayesian credible interval for the difference (TAVR-SAVR) was (-4.4%, 0.4%). The 95% credible interval is the 2.5th and 97.5th percentiles of the posterior distribution.|Primary Hypothesis: TAVR with the Medtronic TAVR system is non-inferior to SAVR for all-cause mortality or disabling stroke rate during a fixed follow-up of 24 months for the Randomized Controlled Trial||||
72451598|NCT01830595|144425452|SUPERIORITY|||||||0.38|||||||t-test, 2 sided|||||||0.38
72451599|NCT01830595|144425454|SUPERIORITY|||||||0.55|||||||t-test, 2 sided|||||||0.55
72451600|NCT01830595|144425455|SUPERIORITY|||||||0.1|||||||t-test, 2 sided|||||||0.10
72561983|NCT01729026|144655004|SUPERIORITY||effect size (Cohen's d)|0.0||||0.982|TWO_SIDED||||||effect size (Cohen's d)|||||||0.982
72561984|NCT01729026|144655005|SUPERIORITY||effect size (Cohen's d)|-0.5||||0.16|TWO_SIDED||||||effect size (Cohen's d)|||||||0.160
72561985|NCT01729026|144655006|SUPERIORITY||effect size (Cohen's d)|-1.36||||0.015|TWO_SIDED|95.0|-2.49|-0.23|||effect size (Cohen's d)|||||-0.23|-2.49|0.015
72561986|NCT01729026|144655007|SUPERIORITY||effect size (Cohen's d)|0.2||||0.59|TWO_SIDED||||||Mixed Models Analysis|||||||0.59
72561987|NCT01729026|144655008|SUPERIORITY||mixed effects regression models|-1.41||||0.01|TWO_SIDED|95.0|-2.5|-0.31|||effect size (Cohen's d)|||||-0.31|-2.50|0.010
72561988|NCT01729026|144655009|SUPERIORITY|||||||0.13|||||||Fisher Exact|||||||0.13
72561989|NCT01729026|144655010|SUPERIORITY||effect size (Cohen's d)|0.9||||0.188|TWO_SIDED||||||effect size (Cohen's d)|||||||0.188
72561990|NCT01729026|144655012|SUPERIORITY||effect size (Cohen's d)|1.2||||0.031|TWO_SIDED||||||mixed effects regression models|||||||0.031
72561991|NCT01729026|144655013|SUPERIORITY||effect size (Cohen's d)|0.3||||0.541|TWO_SIDED|95.0|-0.8|1.4|||effect size (Cohen's d)|||||1.40|-0.80|0.541
72561992|NCT01729026|144655014|SUPERIORITY||effect size (Cohen's d)|0.6||||0.139|TWO_SIDED||||||effect size (Cohen's d)|||Please note that a minus number indicates an increase in pain ratings.||||0.139
72619863|NCT05259722|144770867|SUPERIORITY||Mean Difference (Net)|334.0|||<|0.001|TWO_SIDED|95.0|195.69|472.26|||ANCOVA|||The AUC was analysed using a robust ANCOVA model with effects of treatment group, hyperkeratotic/non-hyperkeratotic subtype and baseline value of the score. Missing data was imputed with WOCF. Data after initiation of rescue treatment or permanent discontinuation of IMP was treated as missing.||472.26|195.69|<0.001
72451601|NCT00391443|144425456|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.85||||0.211|TWO_SIDED|95.0|0.658|1.097|||Log Rank|||||1.097|0.658|0.2110
72451602|NCT00391443|144425457|SUPERIORITY_OR_OTHER_LEGACY||Relative risk reduction|0.17||||0.2542|TWO_SIDED|95.0|-0.13|0.39|||Fisher Exact|||||0.39|-0.13|0.2542
72451603|NCT03213457|144425510|SUPERIORITY||Odds Ratio (OR)|5.51|||<|0.001|TWO_SIDED|95.0|3.711|8.176||P-value for test of difference is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Month 6||8.176|3.711|< 0.001
72451604|NCT03213457|144425510|SUPERIORITY||Odds Ratio (OR)|4.33|||<|0.001|TWO_SIDED|95.0|2.968|6.331||P-value for test of difference is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Month 12||6.331|2.968|< 0.001
72451605|NCT03213457|144425511|SUPERIORITY||Odds Ratio (OR)|1.82|||<|0.001|TWO_SIDED|95.0|1.275|2.605||P-value for test of difference is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Month 6||2.605|1.275|< 0.001
72451606|NCT03213457|144425511|SUPERIORITY||Odds Ratio (OR)|1.63||||0.007|TWO_SIDED|95.0|1.146|2.326||P-value for test of difference is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Month 12||2.326|1.146|0.007
72451607|NCT03213457|144425512|SUPERIORITY||Least Squares (LS) Mean of Difference|-0.99|STANDARD_ERROR_OF_MEAN|0.094|<|0.001|TWO_SIDED|95.0|-1.18|-0.809||P value for the test of the difference is from an MMRM with the fixed categorical effects of treatment, visit, and treatment-by-visit interaction, and the continuous fixed covariate of baseline pain score, and random effect for participant.|mixed model repeated measures (MMRM)|||Ranked secondary endpoints were tested following a fixed-sequence testing procedure. Testing began with testing each of the co-primary endpoints using alpha of 0.05 (2-sided) for elagolix plus E2/NETA compared to placebo. If both co-primary endpoints achieved statistical significance with elagolix plus E2/NETA as compared to placebo, continued testing was performed for the ranked secondary endpoints following a fixed-sequence testing procedure in the order of endpoints presented.||-0.809|-1.180|< 0.001
72451608|NCT03213457|144425513|SUPERIORITY||LS Mean of Difference|-1.02|STANDARD_ERROR_OF_MEAN|0.088|<|0.001|TWO_SIDED|95.0|-1.19|-0.845||P value for the test of the difference is from an MMRM with the fixed categorical effects of treatment, visit, and treatment-by-visit interaction, and the continuous fixed covariate of baseline pain score, and random effect for participant.|MMRM|||Ranked secondary endpoints were tested following a fixed-sequence testing procedure. Testing began with testing each of the co-primary endpoints using alpha of 0.05 (2-sided) for elagolix plus E2/NETA compared to placebo. If both co-primary endpoints achieved statistical significance with elagolix plus E2/NETA as compared to placebo, continued testing was performed for the ranked secondary endpoints following a fixed-sequence testing procedure in the order of endpoints presented.||-0.845|-1.190|< 0.001
72451609|NCT03213457|144425514|SUPERIORITY||LS Mean of Difference|-0.99|STANDARD_ERROR_OF_MEAN|0.085|<|0.001|TWO_SIDED|95.0|-1.156|-0.823||P value for the test of the difference is from an MMRM with the fixed categorical effects of treatment, visit, and treatment-by-visit interaction, and the continuous fixed covariate of baseline pain score, and random effect for participant.|MMRM|||Ranked secondary endpoints were tested following a fixed-sequence testing procedure. Testing began with testing each of the co-primary endpoints using alpha of 0.05 (2-sided) for elagolix plus E2/NETA compared to placebo. If both co-primary endpoints achieved statistical significance with elagolix plus E2/NETA as compared to placebo, continued testing was performed for the ranked secondary endpoints following a fixed-sequence testing procedure in the order of endpoints presented.||-0.823|-1.156|< 0.001
72451610|NCT03213457|144425515|SUPERIORITY||LS Mean of Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.073||0.002|TWO_SIDED|95.0|-0.367|-0.08||P value for the test of the difference is from an MMRM with the fixed categorical effects of treatment, visit, and treatment-by-visit interaction, and the continuous fixed covariate of baseline pain score, and random effect for participant.|MMRM|||Ranked secondary endpoints were tested following a fixed-sequence testing procedure. Testing began with testing each of the co-primary endpoints using alpha of 0.05 (2-sided) for elagolix plus E2/NETA compared to placebo. If both co-primary endpoints achieved statistical significance with elagolix plus E2/NETA as compared to placebo, continued testing was performed for the ranked secondary endpoints following a fixed-sequence testing procedure in the order of endpoints presented.||-0.080|-0.367|0.002
72451611|NCT03213457|144425516|SUPERIORITY||LS Mean of Difference|-0.21|STANDARD_ERROR_OF_MEAN|0.062|<|0.001|TWO_SIDED|95.0|-0.329|-0.085||P value for the test of the difference is from an MMRM with the fixed categorical effects of treatment, visit, and treatment-by-visit interaction, and the continuous fixed covariate of baseline pain score, and random effect for participant.|MMRM|||Ranked secondary endpoints were tested following a fixed-sequence testing procedure. Testing began with testing each of the co-primary endpoints using alpha of 0.05 (2-sided) for elagolix plus E2/NETA compared to placebo. If both co-primary endpoints achieved statistical significance with elagolix plus E2/NETA as compared to placebo, continued testing was performed for the ranked secondary endpoints following a fixed-sequence testing procedure in the order of endpoints presented.||-0.085|-0.329|< 0.001
72561993|NCT00979212|144655054|SUPERIORITY_OR_OTHER_LEGACY|||||||0.96||||||One-sided test at significance level of 0.05|Fisher Exact|||Null hypothesis (H0) was that the experimental treatment was not effective vs the alternative hypothesis (HA) that it was. H0: OR ≤ 1 vs. HA: OR \> 1, where odds ratio (OR)= \[p2\*(1- p1)\]/ \[p1\*(1- p2)\], p1 denotes the mediastinal clearance rate (MCR) on Induction chemoradiation; p2 denotes the MCR on Induction chemoradiation + panitumumab. Fisher's exact test was used to compare the MCRs; the 95% confidence interval was calculated using Clopper-Pearson method. 97 patients were required.||||0.96
72451612|NCT03213457|144425517|SUPERIORITY||LS Mean of Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.056||0.004|TWO_SIDED|95.0|-0.27|-0.05||P value for the test of the difference is from an MMRM with the fixed categorical effects of treatment, visit, and treatment-by-visit interaction, and the continuous fixed covariate of baseline pain score, and random effect for participant.|MMRM|||Ranked secondary endpoints were tested following a fixed-sequence testing procedure. Testing began with testing each of the co-primary endpoints using alpha of 0.05 (2-sided) for elagolix plus E2/NETA compared to placebo. If both co-primary endpoints achieved statistical significance with elagolix plus E2/NETA as compared to placebo, continued testing was performed for the ranked secondary endpoints following a fixed-sequence testing procedure in the order of endpoints presented.||-0.050|-0.270|0.004
72451613|NCT03213457|144425518|SUPERIORITY||LS Mean of Difference|-2.51|STANDARD_ERROR_OF_MEAN|0.9||0.005|TWO_SIDED|95.0|-4.283|-0.746||P-value for test of difference at each post-baseline time point is from an ANCOVA model with treatment as the main effect and baseline as a covariate.|ANCOVA|||Ranked secondary endpoints were tested following a fixed-sequence testing procedure. Testing began with testing each of the co-primary endpoints using alpha of 0.05 (2-sided) for elagolix plus E2/NETA compared to placebo. If both co-primary endpoints achieved statistical significance with elagolix plus E2/NETA as compared to placebo, continued testing was performed for the ranked secondary endpoints following a fixed-sequence testing procedure in the order of endpoints presented.||-0.746|-4.283|0.005
72561994|NCT04269993|144655062|SUPERIORITY||Mean Difference (Final Values)|-2.0||||0.04|TWO_SIDED||||||t-test, 1 sided|||||||0.04
72619864|NCT05259722|144770868|SUPERIORITY||Mean Difference (Net)|-24.5|||<|0.001|TWO_SIDED|95.0|-32.55|-16.36|||ANCOVA|||The change from baseline was analysed using an ANCOVA model with effects of treatment group, hyperkeratotic/non-hyperkeratotic subtype and baseline value of the score. Missing data was imputed with WOCF. Data after initiation of rescue treatment or permanent discontinuation of IMP was treated as missing.||-16.36|-32.55|<0.001
72391339|NCT03000439|144289797|OTHER||Difference in percentage|0.23|||||TWO_SIDED|95.0|-24.24|24.7|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 24||24.70|-24.24|
72391340|NCT03000439|144289797|OTHER||Difference in percentage|3.46|||||TWO_SIDED|95.0|-20.75|27.66|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 28||27.66|-20.75|
72391341|NCT03000439|144289797|OTHER||Difference in percentage|5.99|||||TWO_SIDED|95.0|-16.29|28.28|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 32||28.28|-16.29|
72391342|NCT03000439|144289797|OTHER||Difference in percentage|3.8|||||TWO_SIDED|95.0|-20.92|28.52|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 36||28.52|-20.92|
72391343|NCT03000439|144289797|OTHER||Difference in percentage|10.25|||||TWO_SIDED|95.0|-13.88|34.39|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 40||34.39|-13.88|
72451614|NCT03213457|144425519|SUPERIORITY||LS Mean of Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.098||0.284|TWO_SIDED|95.0|-0.298|0.088||P value for the test of the difference is from an MMRM with the fixed categorical effects of treatment, visit, and treatment-by-visit interaction, and the continuous fixed covariate of baseline pain score, and random effect for participant.|MMRM|||Ranked secondary endpoints were tested following a fixed-sequence testing procedure. Testing began with testing each of the co-primary endpoints using alpha of 0.05 (2-sided) for elagolix plus E2/NETA compared to placebo. If both co-primary endpoints achieved statistical significance with elagolix plus E2/NETA as compared to placebo, continued testing was performed for the ranked secondary endpoints following a fixed-sequence testing procedure in the order of endpoints presented.||0.088|-0.298|0.284
72451615|NCT03213457|144425520|SUPERIORITY||LS Mean of Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.092||0.286|TWO_SIDED|95.0|-0.279|0.083||P value for the test of the difference is from an MMRM with the fixed categorical effects of treatment, visit, and treatment-by-visit interaction, and the continuous fixed covariate of baseline pain score, and random effect for participant.|MMRM|||Ranked secondary endpoints were tested following a fixed-sequence testing procedure. Testing began with testing each of the co-primary endpoints using alpha of 0.05 (2-sided) for elagolix plus E2/NETA compared to placebo. If both co-primary endpoints achieved statistical significance with elagolix plus E2/NETA as compared to placebo, continued testing was performed for the ranked secondary endpoints following a fixed-sequence testing procedure in the order of endpoints presented.||0.083|-0.279|0.286
72451616|NCT03213457|144425521|SUPERIORITY||LS Mean of Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.079||0.005|TWO_SIDED|95.0|-0.375|-0.066||P value for the test of the difference is from an MMRM with the fixed categorical effects of treatment, visit, and treatment-by-visit interaction, and the continuous fixed covariate of baseline pain score, and random effect for participant.|MMRM|||Ranked secondary endpoints were tested following a fixed-sequence testing procedure. Testing began with testing each of the co-primary endpoints using alpha of 0.05 (2-sided) for elagolix plus E2/NETA compared to placebo. If both co-primary endpoints achieved statistical significance with elagolix E2/NETA as compared to placebo, continued testing was performed for the ranked secondary endpoints following a fixed-sequence testing procedure in the order of endpoints presented.||-0.066|-0.375|0.005
72561995|NCT02174276|144655076|SUPERIORITY|Estimated differences in treatment effects between GS-4774 treatment groups and the TDF only group at Week 24 are presented with the 95% CIs and unadjusted P-values.|Least Square Mean Difference|-0.017||||0.805|TWO_SIDED|95.0|-0.155|0.12|||Mixed-Effect Model for Repeated Measures|||The null hypotheses was that the mean change from baseline in serum HBsAg in each of the TDF + GS-4774 groups was equal to the mean change from baseline in serum HBsAg in the TDF only group. Each null hypothesis was tested against the 2-sided alternative hypothesis that the mean change from baseline in serum HBsAg was not equal between each of the respective GS-4774 dose groups and the TDF only group.||0.120|-0.155|0.805
72619865|NCT00498485|144770898|SUPERIORITY_OR_OTHER||||||<|0.04|||||||Wilcoxon (Mann-Whitney)|||Null Hypothesis = drug-treated would have a higher global impression of change than placebo treated.||||<0.04
72619866|NCT00066937|144770900|OTHER||||||<|0.05|||||||ANOVA|Repeated measures ANOVAs compared baseline to each timepoint||||||<.05
72391344|NCT03000439|144289797|OTHER||Difference in percentage|20.62|||||TWO_SIDED|95.0|-3.43|44.67|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 44||44.67|-3.43|
72391345|NCT03000439|144289797|OTHER||Difference in percentage|20.62|||||TWO_SIDED|95.0|-3.43|44.67|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 48||44.67|-3.43|
72619867|NCT00066937|144770901|OTHER||||||<|0.05|||||||ANOVA|Repeated measures ANOVAs compared baseline scores to each period of follow-up (post-treatment, 3-months, 6 months)||||||<.05
72619868|NCT00066937|144770902|OTHER||||||<|0.05|||||||ANOVA|Repeated measures ANOVAs compared baseline scores to each period of follow-up (post-treatment, 3-months, 6 months)||||||<.05
72619869|NCT00066937|144770903|OTHER||||||<|0.05|||||||ANOVA|Repeated measures ANOVAs compared baseline scores to each period of follow-up (post-treatment, 3-months, 6 months)||||||<.05
72619870|NCT03072875|144770904|OTHER|Descriptive statistic.|||||||||||||||||Quantitative data (descriptive statistic) from the USAQ were used to determine feasibility. Specifically, we established an a priori mean score of 3.5 or greater on the USAQ to determine feasibility.|||
72619871|NCT03478787|144770906|NON_INFERIORITY|Non-inferiority is met if the lower bound of the 96.25% confidence interval (CI) of adjusted treatment difference is above -12%.|Adjusted percentage difference|8.2|||||TWO_SIDED|96.25|-2.2|18.6|||||Across the strata, 96.25% confidence interval (CI) for adjusted difference was calculated according to the Cochran-Mantel-Haenszel test for the comparison of 2 treatment groups.|||18.6|-2.2|
72391346|NCT03000439|144289797|OTHER||Difference in percentage|17.4|||||TWO_SIDED|95.0|-7.03|41.82|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 52||41.82|-7.03|
72391347|NCT03000439|144289798|OTHER||Difference in percentage|-26.61|||||TWO_SIDED|95.0|-50.42|-2.81|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 4||-2.81|-50.42|
72451617|NCT03213457|144425522|SUPERIORITY||LS Mean of Difference|-2.49|STANDARD_ERROR_OF_MEAN|1.158||0.032|TWO_SIDED|95.0|-4.773|-0.216||P-value for test of difference at each post-baseline time point is from an ANCOVA model with treatment as the main effect and baseline as a covariate.|ANCOVA|||Ranked secondary endpoints were tested following a fixed-sequence testing procedure. Testing began with testing each of the co-primary endpoints using alpha of 0.05 (2-sided) for elagolix plus E2/NETA compared to placebo. If both co-primary endpoints achieved statistical significance with elagolix plus E2/NETA as compared to placebo, continued testing was performed for the ranked secondary endpoints following a fixed-sequence testing procedure in the order of endpoints presented.||-0.216|-4.773|0.032
72451618|NCT03213457|144425523|SUPERIORITY||LS Mean of Difference|-1.14|STANDARD_ERROR_OF_MEAN|0.322|<|0.001|TWO_SIDED|95.0|-1.774|-0.508||P value for the test of the difference is from an MMRM with the fixed categorical effects of treatment, visit, and treatment-by-visit interaction, and the continuous fixed covariate of baseline pain score, and random effect for participant.|MMRM|||Ranked secondary endpoints were tested following a fixed-sequence testing procedure. Testing began with testing each of the co-primary endpoints using alpha of 0.05 (2-sided) for elagolix plus E2/NETA compared to placebo. If both co-primary endpoints achieved statistical significance with elagolix plus E2/NETA as compared to placebo, continued testing was performed for the ranked secondary endpoints following a fixed-sequence testing procedure in the order of endpoints presented.||-0.508|-1.774|< 0.001
72451619|NCT03213457|144425524|SUPERIORITY||LS Mean of Difference|-1.38|STANDARD_ERROR_OF_MEAN|0.303|<|0.001|TWO_SIDED|95.0|-1.978|-0.788||P value for the test of the difference is from an MMRM with the fixed categorical effects of treatment, visit, and treatment-by-visit interaction, and the continuous fixed covariate of baseline pain score, and random effect for participant.|MMRM|||Ranked secondary endpoints were tested following a fixed-sequence testing procedure. Testing began with testing each of the co-primary endpoints using alpha of 0.05 (2-sided) for elagolix plus E2/NETA compared to placebo. If both co-primary endpoints achieved statistical significance with elagolix plus E2/NETA as compared to placebo, continued testing was performed for the ranked secondary endpoints following a fixed-sequence testing procedure in the order of endpoints presented.||-0.788|-1.978|< 0.001
72451620|NCT03213457|144425525|SUPERIORITY||LS Mean of Difference|-1.46|STANDARD_ERROR_OF_MEAN|0.276|<|0.001|TWO_SIDED|95.0|-2.002|-0.915||P value for the test of the difference is from an MMRM with the fixed categorical effects of treatment, visit, and treatment-by-visit interaction, and the continuous fixed covariate of baseline pain score, and random effect for participant.|MMRM|||Ranked secondary endpoints were tested following a fixed-sequence testing procedure. Testing began with testing each of the co-primary endpoints using alpha of 0.05 (2-sided) for elagolix plus E2/NETA compared to placebo. If both co-primary endpoints achieved statistical significance with elagolix plus E2/NETA as compared to placebo, continued testing was performed for the ranked secondary endpoints following a fixed-sequence testing procedure in the order of endpoints presented.||-0.915|-2.002|< 0.001
72451621|NCT04940624|144425526|SUPERIORITY||Hodges-Lehmann Location Shift Estimate|-15.64|||=|0.061|TWO_SIDED|95.0|-31.3|0.24||The p-value was calculated by Rank Analysis of Covariance (ANCOVA) model using treatment group, age stratum (≤6 years, \>6 years), and rank of Baseline seizure frequency per 28 days as predictors.|ANCOVA||The location shift between soticlestat and placebo (soticlestat - placebo) and its asymptotic 95% confidence interval (CI) were based on the Hodges-Lehmann estimation.|||0.24|-31.30|=0.061
72451622|NCT04940624|144425527|SUPERIORITY||Hodges-Lehmann Location Shift Estimate|-14.29|||=|0.089|TWO_SIDED|95.0|-30.51|1.53||The p-value was calculated by the Rank ANCOVA model using treatment group, age stratum (≤6 years, \>6 years), and rank of baseline seizure frequency per 28 days as predictors.|ANCOVA||The location shift between soticlestat and placebo (soticlestat - placebo) and its asymptotic 95% CI were based on the Hodges-Lehmann estimation.|||1.53|-30.51|=0.089
72391348|NCT03000439|144289798|OTHER||Difference in percentage|-20.16|||||TWO_SIDED|95.0|-43.91|3.59|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 8||3.59|-43.91|
72451623|NCT04940624|144425528|SUPERIORITY||Odds Ratio (OR)|3.22|||=|0.01|TWO_SIDED|95.0|1.3|7.96|||Cochran-Mantel-Haenszel|The p-value was based on Cochran-Mantel-Haenszel (CMH) test stratified by age stratum (≤6 years, \>6 years).||||7.96|1.30|=0.010
72451624|NCT04940624|144425529|SUPERIORITY||Odds Ratio (OR)|3.59|||=|0.008|TWO_SIDED|95.0|1.36|9.49|||Cochran-Mantel-Haenszel|The p-value was based on CMH test stratified by age stratum (≤6 years, \>6 years).||||9.49|1.36|=0.008
72451625|NCT04940624|144425531|SUPERIORITY||Odds Ratio (OR)|2.51|||=|0.004|TWO_SIDED|95.0|1.33|4.72|||Cumulative Logit Model|P-value was calculated using the Cumulative Logit model including treatment and age group as factors.||||4.72|1.33|=0.004
72451626|NCT04940624|144425532|SUPERIORITY||Odds Ratio (OR)|2.58|||=|0.003|TWO_SIDED|95.0|1.37|4.87|||Cumulative Logit Model|P-value was calculated using the Cumulative Logit model including treatment and age group as factors.||||4.87|1.37|=0.003
72451627|NCT04940624|144425533|SUPERIORITY||Odds Ratio (OR)|1.12|||=|0.741|TWO_SIDED|95.0|0.56|2.26|||Cumulative Logit Model|P-value was calculated using the Cumulative Logit model including treatment and age group as factors.||Alertness||2.26|0.56|=0.741
72451628|NCT04940624|144425533|SUPERIORITY||Odds Ratio (OR)|1.04|||=|0.901|TWO_SIDED|95.0|0.54|2.02|||Cumulative Logit Model|P-value was calculated using the Cumulative Logit model including treatment and age group as factors.||Communication||2.02|0.54|=0.901
72451629|NCT04940624|144425533|SUPERIORITY||Odds Ratio (OR)|1.15|||=|0.693|TWO_SIDED|95.0|0.58|2.28|||Cumulative Logit Model|P-value was calculated using the Cumulative Logit model including treatment and age group as factors.||Disruptive Behaviors||2.28|0.58|=0.693
72451630|NCT04940624|144425534|SUPERIORITY||Least Square Mean Difference|-3.03|||=|0.189|TWO_SIDED|95.0|-7.59|1.52||P-value was based on MMRM analysis with change from baseline as outcome and baseline score as fixed continuous effect; treatment group, age stratum, analysis visit, and analysis visit by treatment group interaction as fixed categorical effects.|MMRM|||||1.52|-7.59|=0.189
72451631|NCT04940624|144425535|SUPERIORITY||Odds Ratio (OR)|3.65|||<|0.001|TWO_SIDED|95.0|1.87|7.13|||Cumulative Logit Model|P-value was calculated using the Cumulative Logit model including treatment and age group as factors.||||7.13|1.87|<0.001
72391349|NCT03000439|144289798|OTHER||Difference in percentage|-9.79|||||TWO_SIDED|95.0|-34.31|14.72|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 12||14.72|-34.31|
72391350|NCT03000439|144289798|OTHER||Difference in percentage|0.23|||||TWO_SIDED|95.0|-24.24|24.7|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 16||24.70|-24.24|
72391351|NCT03000439|144289798|OTHER||Difference in percentage|10.25|||||TWO_SIDED|95.0|-13.88|34.39|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 20||34.39|-13.88|
72391352|NCT03000439|144289798|OTHER||Difference in percentage|-3.0|||||TWO_SIDED|95.0|-27.67|21.68|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 24||21.68|-27.67|
72391353|NCT03000439|144289798|OTHER||Difference in percentage|-3.0|||||TWO_SIDED|95.0|-27.67|21.68|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 28||21.68|-27.67|
72391354|NCT03000439|144289798|OTHER||Difference in percentage|-6.91|||||TWO_SIDED|95.0|-30.65|16.83|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 32||16.83|-30.65|
72391355|NCT03000439|144289798|OTHER||Difference in percentage|3.8|||||TWO_SIDED|95.0|-20.92|28.52|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 36||28.52|-20.92|
72391356|NCT03000439|144289798|OTHER||Difference in percentage|7.03|||||TWO_SIDED|95.0|-17.43|31.48|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 40||31.48|-17.43|
72391357|NCT03000439|144289798|OTHER||Difference in percentage|17.74|||||TWO_SIDED|95.0|-7.03|42.52|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 44||42.52|-7.03|
72451632|NCT04940624|144425536|SUPERIORITY||Hodges-Lehmann Location Shift Estimate|-9.97|||=|0.565|TWO_SIDED|95.0|-29.01|7.87|||ANCOVA|The Rank ANCOVA model used treatment group, age stratum (≤6 years, \>6 years), and rank of Baseline seizure frequency per 28 days as predictors.|The location shift between soticlestat and placebo (soticlestat - placebo) and its asymptotic 95% CI were based on the Hodges-Lehmann estimation.|||7.87|-29.01|=0.565
72451633|NCT04940624|144425537|SUPERIORITY||Hodges-Lehmann Location Shift Estimate|-8.13|||=|0.637|TWO_SIDED|94.0|-26.31|10.13|||ANCOVA|The Rank ANCOVA model used treatment group, age stratum (≤6 years, \>6 years), and rank of Baseline seizure frequency per 28 days as predictors.|The location shift between soticlestat and placebo (soticlestat - placebo) and its asymptotic 95% CI were based on the Hodges-Lehmann estimation.|||10.13|-26.31|=0.637
72451634|NCT04940624|144425538|SUPERIORITY||Least Square Mean Difference|0.79|||||TWO_SIDED|95.0|-3.81|5.4|||||A linear model with treatment group and age stratum as factors and baseline percentage as a covariate was used for analysis.|||5.40|-3.81|
72451635|NCT04940624|144425539|SUPERIORITY||Least Square Mean Difference|5.6|||||TWO_SIDED|95.0|0.1|11.2||||||||11.2|0.1|
72451636|NCT04940624|144425540|SUPERIORITY||Least Square Mean Difference|-1.1|||||TWO_SIDED|95.0|-3.1|1.0|||||Least square mean difference was estimated using a linear model with treatment group and age stratum as factors.|||1.0|-3.1|
72451637|NCT02382003|144425541|SUPERIORITY||Mean Difference (Net)|10.73||||0.005|TWO_SIDED|||||=Positive\~No-training, 0.030=Positive\~50/50 training, 0.833=50/50\~No-training Alpha = .05|Likelihood Ratio Tests|2=df Positive\~No-training, 2=df Positive\~50/50 training, 2=df 50/50\~No-training|=Positive\~No-training, 7.053=Positive\~50/50 training, 0.366=50/50\~No-training|Effect of CBM-I condition: The main effect of CBM-I was represented by three binary variables in the main effect models (Positive vs. No-training control; 50/50 vs. No- training control; Positive vs. 50/50). Due to high attrition, latent growth curve modeling was used instead of the planned approach (mixed effects models with multiple imputation of missing values) to minimize bias due to missing data estimation. Because omnibus tests were not run, results for all comparisons are listed below.||||0.005
72499156|NCT00619957|144528683|SUPERIORITY_OR_OTHER||LS Mean Difference|3.18|||<|0.0001|TWO_SIDED|95.0|2.19|4.16|||ANOVA|Fixed effects for treatment and pooled center.||A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.||4.16|2.19|<0.0001
72499157|NCT00619957|144528684|SUPERIORITY_OR_OTHER||LS Mean Difference|4.57|||<|0.0001|TWO_SIDED|95.0|3.49|5.66|||ANOVA|Fixed effects for treatment and pooled center.||A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.||5.66|3.49|<0.0001
72619872|NCT03478787|144770907|SUPERIORITY||Adjusted percentage difference|29.8|||<|0.001|TWO_SIDED|95.0|20.8|38.8||Across the strata, p-value was calculated from the from the Cochran-Mantel-Haenszel test adjusted for strata.|Cochran-Mantel-Haenszel||Across the strata, 95% CI for adjusted difference was calculated according to the Cochran-Mantel-Haenszel test for the comparison of 2 treatment groups.|||38.8|20.8|< 0.001
72619873|NCT03478787|144770908|SUPERIORITY||Adjusted percentage difference|26.2|||<|0.001|TWO_SIDED|95.0|15.9|36.5||Across the strata, p-value was calculated from the from the Cochran-Mantel-Haenszel test adjusted for strata.|Cochran-Mantel-Haenszel||Across the strata, 95% CI for adjusted difference was calculated according to the Cochran-Mantel-Haenszel test for the comparison of 2 treatment groups.|||36.5|15.9|< 0.001
72391358|NCT03000439|144289798|OTHER||Difference in percentage|14.52|||||TWO_SIDED|95.0|-10.52|39.55|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 48||39.55|-10.52|
72391359|NCT03000439|144289798|OTHER||Difference in percentage|17.74|||||TWO_SIDED|95.0|-7.03|42.52|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 52||42.52|-7.03|
72451638|NCT02382003|144425541|SUPERIORITY||Mean Difference (Net)|0.449||||0.799|TWO_SIDED|||||=Neutral\~Anxiety prime Alpha = .05|Likelihood Ratio Tests|2=df Neutral\~Anxiety prime|=Neutral\~Anxiety prime|Effect of Imagery Prime Type: The main effect of imagery prime was represented by one binary variable (neutral vs. anxiety imagery). Due to high attrition, latent growth curve modeling was used instead of the planned approach (mixed effects models with multiple imputation of missing values) to minimize bias due to missing data estimation. Because omnibus tests were not run, results for all comparisons are listed below.||||0.799
72451639|NCT02382003|144425541|SUPERIORITY||Mean Difference (Net)|9.085||||0.011|TWO_SIDED|||||=No-train+Neut\~Pos+Anx, 0.026=No-train+Neut\~Pos+Neut, 0.094=No-train+Anx\~Pos+Anx, 0.170=No-train+Anx\~Pos+Neut, No-train(all)\~50/50(all)≥ 0.136|Likelihood Ratio Tests|2=all df|=No-train+Neut\~Pos+Anx, 7.328=No-train+Neut\~Pos+Neut, 4.722=No-train+Anx\~Pos+Anx, 3.547=No-train+Anx\~Pos+Neut, No-train(all)\~50/50(all)≤3.988|Effect of CBM-I condition and Imagery Prime Type interaction: Each cell of the interaction was represented by one of 5 binary variables, set to 1 if a participant was in that group, and 0 otherwise; the sixth group (No-training + neutral prime) was considered a reference group, and was represented by all variables being 0. Due to high attrition, latent growth curve modeling was used instead of the planned approach. Because omnibus tests were not run, results for all comparisons are listed below.||||0.011
72451640|NCT02382003|144425542|SUPERIORITY||Mean Difference (Net)|11.551||||0.003|TWO_SIDED|||||"=Positive\~No-training, 0.130=Positive\~50/50 training, 0.269=50/50\~No-training~Alpha = .05"|Likelihood Ratio Tests|2=Positive\~No-training, 2=Positive\~50/50 training, 2=50/50\~No-training|=Positive\~No-training, 4.075=Positive\~50/50 training, 2.630=50/50\~No-training|Effect of CBM-I condition: The main effect of CBM-I was represented by three binary variables in the main effect models (Positive vs. No-training control; 50/50 vs. No- training control; Positive vs. 50/50). Due to high attrition, latent growth curve modeling was used instead of the planned approach (mixed effects models with multiple imputation of missing values) to minimize bias due to missing data estimation. Because omnibus tests were not run, results for all comparisons are listed below.||||0.003
72451641|NCT02382003|144425542|SUPERIORITY||Mean Difference (Net)|3.933||||0.14|TWO_SIDED|||||Alpha = .05|Likelihood Ratio Tests|2=df Neutral\~Anxiety prime||Effect of Imagery Prime Type: The main effect of imagery prime was represented by one binary variable (neutral vs. anxiety imagery). Due to high attrition, latent growth curve modeling was used instead of the planned approach (mixed effects models with multiple imputation of missing values) to minimize bias due to missing data estimation. Because omnibus tests were not run, results for all comparisons are listed below.||||0.140
72451642|NCT02382003|144425542|SUPERIORITY||Mean Difference (Net)|6.018||||0.049|TWO_SIDED|||||=No-train+Neut\~Pos+Anx,0.049=No-train+Neut\~Pos+Neut,Positive(all)\~No-train+Anx≥0.198,50/50(all)\~No-train+Anx≥0.104,0.014=No-train+Neut\~50/50+Neut,0.627=No-train+Neut\~50/50+Anx,0.021=Pos+Anx\~50/50+Anx,0.764=Pos+Anx\~50/50+Neut,Pos+Neut\~50/50(all)≥0.067|Likelihood Ratio Tests|2=all df|=No-train+Neut\~Pos+Anx,6.041=No-train+Neut\~Pos+Neut,Positive(all)\~No-train+Anx≤3.240,50/50(all)\~No-train+Anx≤4.534,8.525=No-train+Neut\~50/50+Neut,0.933=No-train+Neut\~50/50+Anx,7.686=Pos+Anx\~50/50+Anx,0.537=Pos+Anx\~50/50+Neut,Pos+Neut\~50/50(all)≤5.395|Effect of CBM-I condition and Imagery Prime Type interaction: Each cell of the interaction was represented by one of 5 binary variables, set to 1 if a participant was in that group, and 0 otherwise; the sixth group (No-training + neutral prime) was considered a reference group, and was represented by all variables being 0. Due to high attrition, latent growth curve modeling was used instead of the planned approach. Because omnibus tests were not run, results for all comparisons are listed below.||||0.049
72451643|NCT02382003|144425543|SUPERIORITY||Mean Difference (Net)|17.42|||<|0.001|TWO_SIDED|||||=Positive\~No-training, Positive\~50/50 training\<0.001, 0.124=50/50\~No-training Alpha = .05|Likelihood Ratio Tests|2=df Positive\~No-training, 2=df Positive\~50/50 training, 2=df 50/50\~No-training|=Positive\~No-training, 31.921=Positive\~50/50 training, 4.175=50/50\~No-training|Effect of CBM-I condition: The main effect of CBM-I was represented by three binary variables in the main effect models (Positive vs. No-training control; 50/50 vs. No- training control; Positive vs. 50/50). Due to high attrition, latent growth curve modeling was used instead of the planned approach (mixed effects models with multiple imputation of missing values) to minimize bias due to missing data estimation. Because omnibus tests were not run, results for all comparisons are listed below.||||<0.001
72451644|NCT02382003|144425543|SUPERIORITY||Mean Difference (Net)|0.634||||0.728|TWO_SIDED|||||=Neutral\~Anxiety prime Alpha = .05|Likelihood Ratio Tests|2=df Neutral\~Anxiety prime|=Neutral\~Anxiety prime|Effect of Imagery Prime Type: The main effect of imagery prime was represented by one binary variable (neutral vs. anxiety imagery). Due to high attrition, latent growth curve modeling was used instead of the planned approach (mixed effects models with multiple imputation of missing values) to minimize bias due to missing data estimation. Because omnibus tests were not run, results for all comparisons are listed below.||||0.728
72451645|NCT02382003|144425543|SUPERIORITY||Mean Difference (Net)|15.034|||<|0.001|TWO_SIDED|||||=Pos+Anx\~No-train+Neut, 0.026=Pos+Anx\~No-train+Anx, 0.002=Pos+Neut\~No-train+Neut, 0.091=Pos+Neut\~No-train+Anx, 50/50(all)\~No-train(all)≥ 0.081, Positive(all)\~50/50(all)\< 0.001|Likelihood Ratio Tests|2=all df|=Pos+Anx\~No-train+Neut, 7.306=Pos+Anx\~No-train+Anx, 12.672=Pos+Neut\~No-train+Neut, 4.802=Pos+Neut\~No-train+Anx, 50/50(all)\~No-train(all)≤5.037, Positive(all)\~50/50(all)≥16.239|Effect of CBM-I condition and Imagery Prime Type interaction: Each cell of the interaction was represented by one of 5 binary variables, set to 1 if a participant was in that group, and 0 otherwise; the sixth group (No-training + neutral prime) was considered a reference group, and was represented by all variables being 0. Due to high attrition, latent growth curve modeling was used instead of the planned approach. Because omnibus tests were not run, results for all comparisons are listed below.||||<0.001
72469964|NCT01080300|144463898|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-1.7|STANDARD_ERROR_OF_MEAN|0.311||0.0003|TWO_SIDED|95.0|-2.31|-1.09||P-value for the test of difference of the least square mean change from baseline between Gabapentin ER 1800 mg and placebo group is based on the F-test of Type III analysis.|Based on Van Eltereen|Multiplicity addressed by requiring significance for all primary endpoints.|Based on ANCOVA|"Baseline LOCF Average Daily Frequency at Week 4:~Null hypothesis: no treatment differences relative to placebo in mean change from baseline in average daily number of moderate to severe hot flashes at Week 4."||-1.09|-2.31|0.0003
72451646|NCT02382003|144425544|SUPERIORITY||Mean Difference (Net)|13.924|||<|0.001|TWO_SIDED|||||=Positive\~No-training, Positive\~50/50 training\< 0.001, 0.100=50/50\~No-training Alpha = .05|Likelihood Ratio Tests|2=df Positive\~No-training, 2=df Positive\~50/50 training, 2=df 50/50\~No-training|=Positive\~No-training, 15.288=Positive\~50/50 training, 4.605=50/50\~No-training|Effect of CBM-I condition: The main effect of CBM-I was represented by three binary variables in the main effect models (Positive vs. No-training control; 50/50 vs. No- training control; Positive vs. 50/50). Due to high attrition, latent growth curve modeling was used instead of the planned approach (mixed effects models with multiple imputation of missing values) to minimize bias due to missing data estimation. Because omnibus tests were not run, results for all comparisons are listed below.||||< 0.001
72451647|NCT02382003|144425544|SUPERIORITY||Mean Difference (Net)|4.011||||0.135|TWO_SIDED|||||=Neutral\~Anxiety prime Alpha = .05|Likelihood Ratio Tests|2=df Neutral\~Anxiety prime|=Neutral\~Anxiety prime|Effect of Imagery Prime Type: The main effect of imagery prime was represented by one binary variable (neutral vs. anxiety imagery). Due to high attrition, latent growth curve modeling was used instead of the planned approach (mixed effects models with multiple imputation of missing values) to minimize bias due to missing data estimation. Because omnibus tests were not run, results for all comparisons are listed below.||||0.135
72451648|NCT02382003|144425544|SUPERIORITY||Mean Difference (Net)|9.402||||0.009|TWO_SIDED|||||=Pos+Anx\~No-train+Neut, Pos+Anx\~No-train+Anx\<0.048, Pos+Neut\~No-train+Neut\<0.001, 0.055=Pos+Neut\~No-train+Anx, 50/50(all)\~No-train+Anx≥0.139, 0.034=No-train+Neut\~50/50+Neut, 0.340=No-train+Neut\~50/50+Anx, Pos(all)\~50/50(all)≥ 0.087|Likelihood Ratio Tests|2=all df|=Pos+Anx\~No-train+Neut, 6.076=Pos+Anx\~No-train+Anx, 14.525=Pos+Neut\~No-train+Neut, 5.811=Pos+Neut\~No-train+Anx, 50/50(all)\~No-train+Anx≤3.950, 6.770=No-train+Neut\~50/50+Neut, 2.158=No-train+Neut\~50/50+Anx, Pos(all)\~50/50(all)≤4.876|Effect of CBM-I condition and Imagery Prime Type interaction: Each cell of the interaction was represented by one of 5 binary variables, set to 1 if a participant was in that group, and 0 otherwise; the sixth group (No-training + neutral prime) was considered a reference group, and was represented by all variables being 0. Due to high attrition, latent growth curve modeling was used instead of the planned approach. Because omnibus tests were not run, results for all comparisons are listed below.||||0.009
72451649|NCT05714059|144425561|NON_INFERIORITY|The overall mean change in HbA1c, from baseline to end of 3-month study period was estimated and compared by a non-inferiority test to the threshold of -0.38% with a margin of 0.4%.|Mean difference from baseline to exit|-0.4|||<|0.001|TWO_SIDED|95.0|-0.6|-0.3|||Wilcoxon (Mann-Whitney)||This is one arm study, the differences of HbA1c from baseline to exit were summarized for this endpoint|||-0.3|-0.6|<0.001
72451650|NCT05714059|144425561|NON_INFERIORITY|The overall mean change in HbA1c from baseline to end of 3-month study period was estimated and compared by a non-inferiority test to the threshold of -0.50% with a margin of 0.4%. A significance level of 0.025 (one-sided) was used|Mean difference from baseline to exit|-0.7|||<|0.001|TWO_SIDED|95.0|-0.8|-0.6|||t-test, 1 sided||This is one arm study, the differences of HbA1c from baseline to exit were summarized for this endpoint|||-0.6|-0.8|<0.001
72451651|NCT05714059|144425562|NON_INFERIORITY|The mean % of time in range (TIR 70-180 mg/dL) was estimated and compared by a non-inferiority test to the threshold of 65.3% with a margin of 7.5%.|Mean value (Final Values)|71.4|||<|0.001|TWO_SIDED|95.0|69.5|73.3|||Wilcoxon (Mann-Whitney)||This is one arm study, the Percent of Time in Range (TIR 70-180 mg/dL) from the last 6-7 weeks of 3 month study period was summarized for this endpoint.|||73.3|69.5|<0.001
72499158|NCT00619957|144528685|SUPERIORITY_OR_OTHER||LS Mean Difference|0.4||||0.1856|TWO_SIDED|95.0|-0.19|0.99|||ANOVA|Fixed effects for treatment and pooled center.||A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.||0.99|-0.19|0.1856
72499159|NCT00619957|144528686|SUPERIORITY_OR_OTHER||LS Mean Difference|0.65||||0.0346|TWO_SIDED|95.0|0.05|1.25|||ANOVA|Fixed effects for treatment and pooled center.||A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.||1.25|0.05|0.0346
72499160|NCT00619957|144528687|SUPERIORITY_OR_OTHER||LS Mean Difference|1.7|||<|0.0001|TWO_SIDED|95.0|0.98|2.41|||ANOVA|Fixed effects for treatment and pooled center.||A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.||2.41|0.98|<0.0001
72499161|NCT00619957|144528688|SUPERIORITY_OR_OTHER||LS Mean Difference|1.46|||<|0.0001|TWO_SIDED|95.0|0.76|2.17|||ANOVA|Fixed effects for treatment and pooled center.||A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.||2.17|0.76|<0.0001
72619874|NCT03478787|144770909|SUPERIORITY||Adjusted percentage difference|29.8|||<|0.001|TWO_SIDED|95.0|20.9|38.8||Across the strata, p-value was calculated from the from the Cochran-Mantel-Haenszel test adjusted for strata.|Cochran-Mantel-Haenszel||Across the strata, 95% CI for adjusted difference was calculated according to the Cochran-Mantel-Haenszel test for the comparison of 2 treatment groups.|||38.8|20.9|< 0.001
72499162|NCT00619957|144528689|SUPERIORITY_OR_OTHER||LS Mean Difference|0.5||||0.2538|TWO_SIDED|95.0|-0.36|1.36|||ANOVA|Fixed effects for treatment and pooled center.||A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.||1.36|-0.36|0.2538
72451652|NCT05714059|144425562|NON_INFERIORITY|The mean % of time in range (TIR 70-180 mg/dL) was estimated and compared by a non-inferiority test to the threshold of 73.7% with a margin of 7.5%.|Mean value (Final Values)|80.2|||<|0.001|TWO_SIDED|95.0|78.7|81.8|||t-test, 1 sided||This is one arm study, the Percent of Time in Range (TIR 70-180 mg/dL) from the last 6-7 weeks of 3 month study period was summarized for this endpoint.|||81.8|78.7|<0.001
72451653|NCT05714059|144425563|NON_INFERIORITY|The mean % time in hypoglycemia (\< 54 mg/dL) was estimated and compared by a non-inferiority test to the threshold of 0.71% with a margin of 2%.|Mean value (Final Values)|0.4|||<|0.001|TWO_SIDED|95.0|0.3|0.4|||Wilcoxon (Mann-Whitney)||This is one arm study, the Percent of Time in Hypoglycemia (\< 54 mg/dL) from last 6-7 weeks of 3 month study period was estimated for this endpoint.|||0.4|0.3|<0.001
72451654|NCT05714059|144425563|NON_INFERIORITY|The mean % time in hypoglycemia (\< 54 mg/dL) was estimated and compared by a non-inferiority test to the threshold of 0.86% with a margin of 2%.|Mean value (Final Values)|0.2|||<|0.001|TWO_SIDED|95.0|0.1|0.3|||Wilcoxon (Mann-Whitney)||This is one arm study, the Percent of Time in Hypoglycemia (\< 54 mg/dL) were summarized from last 6-7 weeks of 3 month study period for this endpoint|||0.3|0.1|<0.001
72451655|NCT05714059|144425564|SUPERIORITY|The mean % of time in range (TIR 70-180 mg/dL) was estimated and compared to a threshold of 65.3% by a simple superiority test|Mean value (Final Values)|71.4|||<|0.001|TWO_SIDED|95.0|69.5|73.3|||Wilcoxon (Mann-Whitney)||This is one arm study, the Percent of Time in Range (TIR 70-180 mg/dL) from the last 6-7 weeks of 3 month study period was summarized for this endpoint.|||73.3|69.5|<0.001
72451656|NCT05714059|144425564|SUPERIORITY|The mean % of time in range (TIR 70-180 mg/dL) was estimated and compared to a threshold of 73.7% by a simple superiority test|Mean value (Final Values)|80.2|||<|0.001|TWO_SIDED|95.0|78.7|81.8|||t-test, 1 sided||This is one arm study, the Percent of Time in Range (TIR 70-180 mg/dL) from the last 6-7 weeks of 3 month study period was summarized for this endpoint.|||81.8|78.7|<0.001
72451657|NCT05648890|144425583|OTHER|Spearman's rank correlation coefficient was used.|||||<|0.0001|||||||Spearman's rank correlation coefficient|||Correlation between MMSE and TEGEST test before operation.||||<0.0001
72451658|NCT05648890|144425584|OTHER|Spearman's ran correlation coefficient was used .|||||<|0.001|||||||Spearman's ran correlation coefficient|Spearman's ran correlation coefficient was used for correlation between two quantities.||Correlation between MMSE and TEGEST after operation||||< .001
72451659|NCT05648890|144425585|OTHER|Spearman's rank correlation coefficient was used.|||||<|0.0001|||||||Spearman's rank correlation coefficient|||Correlation between TEGEST and Clock drawing test before operation.|Spearman's rank correlation coefficient was used.|||<0.0001
72451660|NCT05648890|144425586|OTHER|Spearman's rank correlation coefficient was used.|||||<|0.001|||||||Spearman's rank correlation coefficient|||Correlation between TEGEST and clock drawing test after operation.||||<0.001
72451661|NCT05648890|144425587|OTHER|Spearman's rank correlation coefficient.|||||<|0.001|||||||Spearman's rank correlation coefficien|||Correlation between MMSE and Clock drawing test before operation.||||<0.001
72451662|NCT05648890|144425587|OTHER|Mann-Whitney U test before operation.||||||0.023|||||||Wilcoxon (Mann-Whitney)|||Clock drawing before operation.||||0.023
72451663|NCT05648890|144425588|OTHER|Spearman's rank correlation coefficient|||||<|0.0001|||||||Spearman's rank correlation coefficient|||Correlation between Clock drawing test and MMSE after operation.||||<0.0001
72451664|NCT05648890|144425589|OTHER|Spearman's rank correlation coefficient was used.|||||<|0.0001|||||||Spearman's rank correlation coefficient|||Correlation of Clinical frailty scale with MMSE before operation.||||<0.0001
72451665|NCT05648890|144425589|OTHER|Spearman's rank correlation coefficient was used.|||||<|0.0001|||||||Spearman's rank correlation coefficient|||Correlation of Clinical frailty scale with TEGEST before operation.||||<0.0001
72451666|NCT05648890|144425589|OTHER|Spearman's rank correlation coefficient was used.|||||<|0.0001|||||||Spearman's rank correlation coefficient|||Correlation of Clinical frailty scale with Clock drawing test before operation.||||<0.0001
72451667|NCT05648890|144425590|OTHER|Mann-Whitney U test.||||||0.562|||||||Wilcoxon (Mann-Whitney)|||Respondents living at a house or in apartment and relationships with Clinical frailty scale.||||.562
72451668|NCT05648890|144425591|OTHER|Mann-Whitney test was used.||||||0.129|||||||Wilcoxon (Mann-Whitney)|||Respondents living with with family or alone and relationship with Clinical frailty scale.||||0.129
72451669|NCT05648890|144425592|OTHER|Mann-Whintney test was used.||||||0.019|||||||Wilcoxon (Mann-Whitney)|||Relationship between respondents living at home with stairs and respondents living at home with an elevator and Clinical frailty scale.||||0.019
72451670|NCT00650078|144425632|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.25||||0.001|TWO_SIDED|95.0|1.39|3.64||The p-value was based on logistic regression with treatment, geographic region, gender, and median age class as factors.|Regression, Logistic|||||3.64|1.39|0.0010
72451671|NCT00650078|144425633|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-19.6||||0.0015|TWO_SIDED|95.0|-31.7|-6.1||Wilcoxon Rank Sum Test p-value|Hodges-Lehman method|The difference between the treatment groups was assessed using the median and the 95% CI of the median computed using the Hodges Lehmann method.||||-6.1|-31.7|0.0015
72451672|NCT02379351|144425641|OTHER|This pilot study is primarily descriptive statistics||||||0.1|||||||Chi-squared|Data analysis will use mostly descriptive statistics - parametric and nonparametric statistics will be used as indicated (Chi-squared)||||||.1
72451673|NCT02379351|144425642|NON_INFERIORITY|Likert Scale of Provider Satisfaction|||||<|0.01|||||||Chi-squared|Data analysis will use mostly descriptive statistics: parametric and nonparametric statistics will be used as indicated.|||Likert Scale of Provider Satisfaction|||<0.01
72451674|NCT02422615|144425649|SUPERIORITY||Cox Proportional Hazard|0.593||||4.1e-07|TWO_SIDED|95.0|0.48|0.732|||Log Rank|||||0.732|0.480|0.00000041
72451675|NCT02422615|144425650|SUPERIORITY||Cox Proportional Hazard|0.724||||0.00455|TWO_SIDED|95.0|0.568|0.924|||Log Rank|||||0.924|0.568|0.00455
72451676|NCT02422615|144425651|SUPERIORITY||Cox Proportional Hazard|0.492|||||TWO_SIDED|95.0|0.345|0.703||||||||0.703|0.345|
72451677|NCT05934292|144425692|OTHER||Geometric Mean Ratio|1.5|||||TWO_SIDED|90.0|0.98|2.31|||||Geometric mean ratio (GMR) and 90% confidence interval (CI) were calculated using a linear fixed effects model performed on natural log-transformed values. GMR: Panel A-Moderate Renal Impairment (RI)/Panel D-Healthy controls|||2.31|0.98|
72451678|NCT05934292|144425692|OTHER||Geometric Mean Ratio|1.14|||||TWO_SIDED|90.0|0.74|1.74|||Geometric Mean Ratio||GMR and 90% confidence interval (CI) were calculated using a linear fixed effects model performed on natural log-transformed values. GMR: Panel B-Severe RI/Panel D-Healthy controls|||1.74|0.74|
72451679|NCT05934292|144425692|OTHER||Geometric Mean Ratio|1.75|||||TWO_SIDED|90.0|1.1|2.78|||||GMR and 90% CI were calculated using a linear fixed effects model performed on natural log-transformed values. GMR: Panel C-ESRD Enlicitide Decanoate Pre-Hemodialysis/ Panel D-Healthy Controls|||2.78|1.10|
72451680|NCT05934292|144425692|OTHER||Geometric Mean Ratio|1.17|||||TWO_SIDED|90.0|0.77|1.77|||||GMR and 90% CI were calculated using a linear fixed effects model performed on natural log-transformed values. GMR: Panel C-ESRD Enlicitide Decanoate Post-Hemodialysis/ Panel D-Healthy Controls|||1.77|0.77|
72451681|NCT05934292|144425693|OTHER||Geometric Mean Ratio|1.61|||||TWO_SIDED|90.0|1.05|2.46|||||GMR and 90% confidence interval (CI) were calculated using a linear fixed effects model performed on natural log-transformed values. GMR: Panel A-Moderate Renal Impairment (RI)/Panel D-Healthy controls|||2.46|1.05|
72451682|NCT05934292|144425693|OTHER||Geometric Mean ratio|0.79|||||TWO_SIDED|90.0|0.37|1.72|||||GMR and 90% confidence interval (CI) were calculated using a linear fixed effects model performed on natural log-transformed values. GMR: Panel B-Severe RI/Panel D-Healthy controls|||1.72|0.37|
72451683|NCT05934292|144425693|OTHER||Geometric Mean Ratio|1.42|||||TWO_SIDED|90.0|0.8|2.54|||||GMR and 90% CI were calculated using a linear fixed effects model performed on natural log-transformed values. GMR: Panel C-ESRD Enlicitide Decanoate Pre-Hemodialysis/ Panel D-Healthy Controls|||2.54|0.80|
72451684|NCT05934292|144425693|OTHER||Geometric Mean Ratio|1.18|||||TWO_SIDED|90.0|0.78|1.78|||||GMR and 90% CI were calculated using a linear fixed effects model performed on natural log-transformed values. GMR: Panel C-ESRD Enlicitide Decanoate Post-Hemodialysis/ Panel D-Healthy Controls|||1.78|0.78|
72451685|NCT05934292|144425694|OTHER||Geometric Mean Ratio|0.98|||||TWO_SIDED|90.0|0.71|1.37|||||GMR and 90% confidence interval (CI) were calculated using a linear fixed effects model performed on natural log-transformed values. GMR: Panel A-Moderate Renal Impairment (RI)/Panel D-Healthy controls.|||1.37|0.71|
72451686|NCT05934292|144425694|OTHER||Geometric Mean Ratio|0.6|||||TWO_SIDED|90.0|0.34|1.04|||||GMR and 90% confidence interval (CI) were calculated using a linear fixed effects model performed on natural log-transformed values. GMR: Panel B-Severe RI/Panel D-Healthy controls.|||1.04|0.34|
72451687|NCT05934292|144425694|OTHER||Geometric Mean Ratio|0.9|||||TWO_SIDED|90.0|0.64|1.27|||||GMR and 90% confidence interval (CI) were calculated using a linear fixed effects model performed on natural log-transformed values. GMR: Panel C-ESRD Enlicitide Decanoate Pre-Hemodialysis/ Panel D-Healthy Controls.|||1.27|0.64|
72451688|NCT05934292|144425694|OTHER||Geometric Mean Ratio|1.18|||||TWO_SIDED|90.0|0.78|1.78|||||GMR and 90% confidence interval (CI) were calculated using a linear fixed effects model performed on natural log-transformed values. GMR: Panel C-ESRD Enlicitide Decanoate Post-Hemodialysis/ Panel D-Healthy Controls.|||1.78|0.78|
72451689|NCT05934292|144425697|OTHER||Geometric Mean Ratio|0.67|||||TWO_SIDED|90.0|0.43|1.02|||||GMR and 90% CI were calculated using a linear fixed effects model performed on natural log-transformed values. GMR: Panel A-Moderate Renal Impairment (RI)/Panel D-Healthy controls|||1.02|0.43|
72451690|NCT05934292|144425697|OTHER||Geometric Mean Ratio|0.88|||||TWO_SIDED|90.0|0.58|1.35|||||GMR and 90% confidence interval (CI) were calculated using a linear fixed effects model performed on natural log-transformed values. GMR: Panel B-Severe RI/Panel D-Healthy controls|||1.35|0.58|
72451691|NCT05934292|144425697|OTHER||Geomtric Mean ratio|0.57|||||TWO_SIDED|90.0|0.36|0.91|||||GMR and 90% CI were calculated using a linear fixed effects model performed on natural log-transformed values. GMR: Panel C-ESRD Enlicitide Decanoate Pre-Hemodialysis/ Panel D-Healthy Controls|||0.91|0.36|
72451692|NCT05934292|144425697|OTHER||Geomtric Mean Ratio|0.86|||||TWO_SIDED|90.0|0.57|1.29|||||GMR and 90% CI were calculated using a linear fixed effects model performed on natural log-transformed values. GMR: Panel C-ESRD Enlicitide Decanoate Post-Hemodialysis/ Panel D-Healthy Controls|||1.29|0.57|
72451693|NCT05934292|144425698|OTHER||Geometric Mean Ratio|1.18|||||TWO_SIDED|90.0|0.83|1.67|||||GMR and 90% CI were calculated using a linear fixed effects model performed on natural log-transformed values. GMR: Panel A-Moderate Renal Impairment (RI)/Panel D-Healthy controls|||1.67|0.83|
72451694|NCT05934292|144425698|OTHER||Geometric Mean ratio|1.08|||||TWO_SIDED|90.0|0.78|1.5|||||GMR and 90% confidence interval (CI) were calculated using a linear fixed effects model performed on natural log-transformed values. GMR: Panel B-Severe RI/Panel D-Healthy controls|||1.50|0.78|
72451695|NCT05934292|144425698|OTHER||Geometric Mean Ratio|0.66|||||TWO_SIDED|90.0|0.5|0.89|||||GMR and 90% CI were calculated using a linear fixed effects model performed on natural log-transformed values. GMR: Panel C-ESRD Enlicitide Decanoate Pre-Hemodialysis/ Panel D-Healthy Controls|||0.89|0.50|
72451696|NCT05934292|144425698|OTHER||Geometric Mean Ratio|1.4|||||TWO_SIDED|90.0|1.0|1.97|||||GMR and 90% CI for AUC0-inf were calculated using a linear fixed effects model performed on natural log-transformed values. GMR: Panel C-ESRD Enlicitide Decanoate Post-Hemodialysis/ Panel D-Healthy Controls|||1.97|1.00|
72451697|NCT05934292|144425703|OTHER||Geometric Mean Ratio|0.32|||||TWO_SIDED|90.0|0.14|0.74|||||GMR and 90% CI were calculated using a linear fixed effects model performed on natural log-transformed values. GMR: Panel A-Moderate Renal Impairment (RI)/Panel D-Healthy controls|||0.74|0.14|
72451698|NCT05934292|144425703|OTHER||Geometric Mean Ratio|0.09|||||TWO_SIDED|90.0|0.04|0.22|||||GMR and 90% confidence interval (CI) were calculated using a linear fixed effects model performed on natural log-transformed values. GMR: Panel B-Severe RI/Panel D-Healthy controls|||0.22|0.04|
72561996|NCT02174276|144655076|SUPERIORITY|Estimated differences in treatment effects between GS-4774 treatment groups and the TDF only group at Week 24 are presented with the 95% CIs and unadjusted P-values.|Least Square Mean Difference|0.063||||0.37|TWO_SIDED|95.0|-0.075|0.202|||Mixed-Effect Model for Repeated Measures|||The null hypotheses was that the mean change from baseline in serum HBsAg in each of the TDF + GS-4774 groups was equal to the mean change from baseline in serum HBsAg in the TDF only group. Each null hypothesis was tested against the 2-sided alternative hypothesis that the mean change from baseline in serum HBsAg was not equal between each of the respective GS-4774 dose groups and the TDF only group.||0.202|-0.075|0.370
72451699|NCT05934292|144425704|OTHER||Geometric Mean Ratio|0.32|||||TWO_SIDED|90.0|0.14|0.74|||||GMR and 90% CI were calculated using a linear fixed effects model performed on natural log-transformed values. GMR: Panel A-Moderate Renal Impairment (RI)/Panel D-Healthy controls|||0.74|0.14|
72619875|NCT03478787|144770910|SUPERIORITY||Adjusted percentage difference|20.0|||<|0.001|TWO_SIDED|95.0|11.7|28.3||Across the strata, p-value was calculated from the from the Cochran-Mantel-Haenszel test adjusted for strata.|Cochran-Mantel-Haenszel||Across the strata, 95% CI for adjusted difference was calculated according to the Cochran-Mantel-Haenszel test for the comparison of 2 treatment groups.|||28.3|11.7|< 0.001
72451700|NCT05934292|144425704|OTHER||Geometric Mean Ratio|0.09|||||TWO_SIDED|90.0|0.04|0.22|||||GMR and 90% confidence interval (CI) were calculated using a linear fixed effects model performed on natural log-transformed values. GMR: Panel B-Severe RI/Panel D-Healthy controls|||0.22|0.04|
72451701|NCT05934292|144425705|OTHER||Geometric Mean Ratio|0.29|||||TWO_SIDED|90.0|0.16|0.55|||||GMR and 90% CI were calculated using a linear fixed effects model performed on natural log-transformed values. GMR: Panel A-Moderate Renal Impairment (RI)/Panel D-Healthy controls|||0.55|0.16|
72561997|NCT02174276|144655076|SUPERIORITY|Estimated differences in treatment effects between GS-4774 treatment groups and the TDF only group at Week 24 are presented with the 95% CIs and unadjusted P-values.|Least Square Mean Difference|-0.056||||0.426|TWO_SIDED|95.0|-0.194|0.082|||Mixed-Effect Model for Repeated Measures|||The null hypotheses was that the mean change from baseline in serum HBsAg in each of the TDF + GS-4774 groups was equal to the mean change from baseline in serum HBsAg in the TDF only group. Each null hypothesis was tested against the 2-sided alternative hypothesis that the mean change from baseline in serum HBsAg was not equal between each of the respective GS-4774 dose groups and the TDF only group.||0.082|-0.194|0.426
72561998|NCT00434837|144655109|SUPERIORITY|||||||0.27|||||||ANOVA|||These results are from the 3-year analysis.||||.27
72561999|NCT00434837|144655110|SUPERIORITY|||||||0.08|||||||ANOVA|||These results are from the 7-year analysis.||||.08
72562000|NCT00434837|144655111|SUPERIORITY|||||||0.22|||||||ANOVA|||These results are from the 15-year analysis.||||.22
72562001|NCT00434837|144655112|SUPERIORITY|||||||0.0078|||||||ANOVA|||These results are from the 15-year analysis.||||.0078
72451702|NCT05934292|144425705|OTHER||Geometric Mean Ratio|0.14|||||TWO_SIDED|90.0|0.06|0.36|||||GMR and 90% confidence interval (CI) were calculated using a linear fixed effects model performed on natural log-transformed values. GMR: Panel B-Severe RI/Panel D-Healthy controls|||0.36|0.06|
72451703|NCT04479787|144425709|OTHER||||||<|0.0001|||||||Two-sided Z-Test|||||||<0.0001
72562002|NCT00434837|144655113|SUPERIORITY|||||||0.0018|||||||ANOVA|||These results are from the 15-year analysis.||||.0018
72562003|NCT00434837|144655114|SUPERIORITY|||||||0.015|||||||ANOVA|||These results are from the 15-year analysis.||||.015
72562004|NCT00434837|144655115|SUPERIORITY|||||||0.003|||||||ANOVA|||These results are from the 15-year analysis.||||.003
72562005|NCT00434837|144655116|SUPERIORITY|||||||0.0006|||||||ANOVA|||These results are from the 15-year analysis.||||.0006
72562006|NCT00434837|144655117|SUPERIORITY|||||||0.15|||||||ANOVA|||These results are from the 15-year analysis.||||.15
72562007|NCT00434837|144655118|SUPERIORITY|||||||0.34|||||||Chi-squared|||These results are from the 15-year analysis.||||.34
72451704|NCT04479787|144425710|OTHER||||||<|0.0001|||||||Two-sided Z-Test|||||||< 0.0001
72451705|NCT04479787|144425711|OTHER||||||<|0.0001|||||||Two-sample t-test.|||||||<0.0001
72451706|NCT04479787|144425712|OTHER||||||<|0.0001|||||||Two-sample t-test.|||||||<0.0001
72451707|NCT04479787|144425713|OTHER||||||<|0.0001|||||||Two-sided Z-Test|||||||<0.0001
72391360|NCT03000439|144289799|OTHER||Difference in percentage|-15.09|||||TWO_SIDED|95.0|-34.29|4.1|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 4||4.10|-34.29|
72391361|NCT03000439|144289799|OTHER||Difference in percentage|-12.21|||||TWO_SIDED|95.0|-29.08|4.65|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 8||4.65|-29.08|
72451708|NCT04479787|144425714|OTHER||||||<|0.0001|||||||Two-sided Z-Test|||||||<0.0001
72451709|NCT04479787|144425715|OTHER||||||<|0.0001|||||||Two-sample t-test.|||||||<0.0001
72451710|NCT04479787|144425716|OTHER||||||<|0.0001|||||||Two-sample t-test.|||||||<0.0001
72451711|NCT04899674|144425717|OTHER||Ratio of gMeans [%]|94.6|||||TWO_SIDED|90.0|86.3|103.8|||||"Ratio of Geometric Least Squares Means (gMeans) was calculated as (gMean of BI 1358894 + bupropion)/(gMean of bupropion alone). Intra-individual geometric coefficient of variation (gCV \[%\])=13.9."|The statistical model used for the analysis of the primary endpoints was an Analysis of Variance (ANOVA) model. The model included effects accounting for the following sources of variation: 'subjects' and 'treatment'. The effect 'subjects' was considered as random, whereas the effect 'treatment' was considered as fixed.||103.8|86.3|
72451712|NCT04899674|144425718|OTHER||Ratio of gMeans[%]|90.7|||||TWO_SIDED|90.0|74.3|110.7|||||"Ratio of Geometric Least Squares Means (gMeans) was calculated as (gMean of BI 1358894 + bupropion)/(gMean of bupropion alone).~Intra-individual geometric coefficient of variation (gCV \[%\])=31.5."|The statistical model used for the analysis of the primary endpoints was an Analysis of Variance (ANOVA) model. The model included effects accounting for the following sources of variation: 'subjects' and 'treatment'. The effect 'subjects' was considered as random, whereas the effect 'treatment' was considered as fixed.||110.7|74.3|
72562008|NCT00434837|144655119|SUPERIORITY|||||||0.17|||||||ANOVA|||These results are from the 15-year analysis.||||.17
72562009|NCT00434837|144655120|SUPERIORITY|||||||0.25|||||||ANOVA|||These results are from the 15-year analysis.||||.25
72391362|NCT03000439|144289799|OTHER||Difference in percentage|-8.99|||||TWO_SIDED|95.0|-25.07|7.1|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 12||7.10|-25.07|
72562010|NCT00434837|144655121|SUPERIORITY|||||||0.61|||||||ANOVA|||These results are from the 15-year analysis.||||.61
72562011|NCT00434837|144655122|SUPERIORITY|||||||0.15|||||||ANOVA|||These results are from the 15-year analysis.||||.15
72562012|NCT00434837|144655123|SUPERIORITY|||||||0.53|||||||ANOVA|||These results are from the 15-year analysis.||||.53
72562013|NCT00434837|144655124|SUPERIORITY|||||||0.82|||||||ANOVA|||These results are from the 15-year analysis.||||.82
72562014|NCT00434837|144655125|SUPERIORITY|||||||0.03|||||||ANOVA|||These results are from the 15-year analysis.||||.03
72562015|NCT00434837|144655126|SUPERIORITY|||||||0.67|||||||ANOVA|||These results are from the 15-year analysis.||||.67
72562016|NCT00434837|144655128|SUPERIORITY|||||||0.051|||||||ANOVA|||These results are from the 15-year analysis.||||.051
72562017|NCT00434837|144655129|SUPERIORITY|||||||0.14|||||||ANOVA|||These results were from the 15-year analysis.||||.14
72562018|NCT00434837|144655130|SUPERIORITY|||||||0.067|||||||ANOVA|||These results are from the 15-year analysis.||||.067
72562019|NCT00434837|144655131|SUPERIORITY|||||||0.54|||||||ANOVA|||These results were from the 7-year analysis.||||.54
72562020|NCT00434837|144655132|SUPERIORITY|||||||0.08|||||||ANOVA|||These results are from the 15-year analysis.||||.08
72562021|NCT02786927|144655160|OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
72451713|NCT04899674|144425719|OTHER||Ratio of gMeans [%]|95.1|||||TWO_SIDED|90.0|86.7|104.3|||||"Ratio of Geometric Least Squares Means (gMeans) was calculated as (gMean of BI 1358894 + bupropion)/(gMean of bupropion alone).~Standard deviation is actually intra-individual geometric coefficient of variation (gCV \[%\])=13.9."|The statistical model used for the analysis of the primary endpoints was an Analysis of Variance (ANOVA). The model included effects accounting for the following sources of variation: 'subjects' and 'treatment'. The effect 'subjects' was considered as random, whereas the effect 'treatment' was considered as fixed.||104.3|86.7|
72451714|NCT05155306|144425726|OTHER||Geometric mean ratio [%]|89.1|||||TWO_SIDED|90.0|79.5|99.7|||||Ratio is calculated as test/reference. Geometric Standard Error = 1.067.|Analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: sequence, subjects within sequences, period and treatment. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||99.7|79.5|
72451715|NCT05155306|144425726|OTHER||Geometric mean ratio [%]|98.1|||||TWO_SIDED|90.0|94.4|101.9|||||Ratio is calculated as test/reference. Geometric Standard Error = 1.022.|Analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: sequence, subjects within sequences, period and treatment. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||101.9|94.4|
72451716|NCT05155306|144425726|OTHER||Geometric mean ratio [%]|202.4|||||TWO_SIDED|90.0|180.1|227.5|||||Ratio is calculated as fed/fasted. Geometric Standard Error = 1.069.|Analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: sequence, subjects within sequences, period and treatment. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||227.5|180.1|
72451717|NCT05155306|144425726|OTHER||Geometric mean ratio [%]|173.8|||||TWO_SIDED|90.0|158.3|190.8|||||Ratio is calculated as fed/fasted. Geometric Standard Error = 1.055.|Analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: sequence, subjects within sequences, period and treatment. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||190.8|158.3|
72499163|NCT00619957|144528690|SUPERIORITY_OR_OTHER||LS Mean Difference|0.86||||0.0537|TWO_SIDED|95.0|-0.01|1.74|||ANOVA|Fixed effects for treatment and pooled center.||A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.||1.74|-0.01|0.0537
72499164|NCT00619957|144528691|SUPERIORITY_OR_OTHER||LS Mean Difference|1.24||||0.0081|TWO_SIDED|95.0|0.32|2.15|||ANOVA|Fixed effects for treatment and pooled center.||A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.||2.15|0.32|0.0081
72451718|NCT05155306|144425727|OTHER||Geometric mean ratio [%]|83.0|||||TWO_SIDED|90.0|69.6|99.0|||||Ratio is calculated as test/reference. Geometric Standard Error = 1.106.|Analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: sequence, subjects within sequences, period and treatment. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||99.0|69.6|
72451719|NCT05155306|144425727|OTHER||Geometric mean ratio [%]|99.7|||||TWO_SIDED|90.0|88.7|112.0|||||Ratio is calculated as test/reference. Geometric Standard Error = 1.070.|Analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: sequence, subjects within sequences, period and treatment. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||112.0|88.7|
72451720|NCT05155306|144425727|OTHER||Geometric mean ratio [%]|153.6|||||TWO_SIDED|90.0|126.0|187.3|||||Ratio is calculated as fed/fasted. Geometric Standard Error = 1.121.|Analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: sequence, subjects within sequences, period and treatment. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||187.3|126.0|
72451721|NCT05155306|144425727|OTHER||Geometric mean ratio [%]|121.4|||||TWO_SIDED|90.0|99.6|147.8|||||Ratio is calculated as fed/fasted. Geometric Standard Error = 1.120.|Analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: sequence, subjects within sequences, period and treatment. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||147.8|99.6|
72451722|NCT05155306|144425728|OTHER||Geometric mean ratio [%]|89.9|||||TWO_SIDED|90.0|80.4|100.4|||||Ratio is calculated as test/reference. Geometric Standard Error = 1.066.|Analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: sequence, subjects within sequences, period and treatment. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||100.4|80.4|
72499165|NCT00619957|144528692|SUPERIORITY_OR_OTHER||LS Mean Difference|1.06||||0.0187|TWO_SIDED|95.0|0.18|1.94|||ANOVA|Fixed effects for treatment and pooled center.||A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.||1.94|0.18|0.0187
72562022|NCT02786927|144655161|OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
72562023|NCT02786927|144655162|OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
72451723|NCT05155306|144425728|OTHER||Geometric mean ratio [%]|100.4|||||TWO_SIDED|90.0|96.8|104.1|||||Ratio is calculated as test/reference. Geometric Standard Error = 1.021.|Analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: sequence, subjects within sequences, period and treatment. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||104.1|96.8|
72451724|NCT05155306|144425728|OTHER||Geometric mean ratio [%]|202.6|||||TWO_SIDED|90.0|179.6|228.5|||||Ratio is calculated as fed/fasted. Geometric Standard Error = 1.072.|Analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: sequence, subjects within sequences, period and treatment. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||228.5|179.6|
72562024|NCT01801917|144655163|SUPERIORITY_OR_OTHER_LEGACY||Bayesian|0.586||||||||||||||It was a Bayesian analysis with non-informative prior for co-primary endpoints, MMT-24 and CK, with dual criteria for statistical significance: ≥ 90% posterior probability (PP) of achieving an increase from baseline in MMT24 and decrease in CK and clinical relevance: ≥ 50% PP achieving an increase of 15 points in MMT24 and a decrease of 30% in CK vs. placebo. For this table the value is the posterior probability of achieving an increase in MMT24 and a decrease in CK in 2mg group vs. placebo||||
72451725|NCT05155306|144425728|OTHER||Geometric mean ratio [%]|172.3|||||TWO_SIDED|90.0|158.2|187.7|||||Ratio is calculated as fed/fasted. Geometric Standard Error = 1.050.|Analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: sequence, subjects within sequences, period and treatment. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||187.7|158.2|
72451726|NCT05601882|144425738|SUPERIORITY|Analyzed using Cochran-Mantel-Haenszel (CMH) test stratified by Validated Investigator's Global Assessment for Atopic Dermatitis categories \[(vIGA-AD (moderate \[3\] versus severe \[4\])\] and age (12 to \< 18; 18 to \< 40; ≥40 to \< 64 years)|Adjusted Response Rate Difference|11.0|||<|0.0001|TWO_SIDED|95.0|6.6|15.5|||Cochran-Mantel-Haenszel||Response rate difference = Upadacitinib (Period 1) - Dupilumab (Period 1)|Upadacitinib (Period 1) vs Dupilumab (Period 1)||15.5|6.6|<0.0001
72451727|NCT05601882|144425739|SUPERIORITY|Analyzed using Cochran-Mantel-Haenszel (CMH) test stratified by Validated Investigator's Global Assessment for Atopic Dermatitis categories \[(vIGA-AD (moderate \[3\] versus severe \[4\])\] and age (12 to \< 18; 18 to \< 40; ≥40 to \< 64 years)|Adjusted Response Rate Difference|18.4|||<|0.0001|TWO_SIDED|95.0|12.5|24.2|||Cochran-Mantel-Haenszel||Response rate difference = Upadacitinib (Period 1) - Dupilumab (Period 1)|Upadacitinib (Period 1) vs Dupilumab (Period 1)||24.2|12.5|<0.0001
72451728|NCT05601882|144425740|SUPERIORITY|Analyzed using Cochran-Mantel-Haenszel (CMH) test stratified by Validated Investigator's Global Assessment for Atopic Dermatitis categories \[(vIGA-AD (moderate \[3\] versus severe \[4\])\] and age (12 to \< 18; 18 to \< 40; ≥40 to \< 64 years)|Adjusted Response Rate Difference|14.7|||<|0.0001|TWO_SIDED|95.0|9.4|20.0|||Cochran-Mantel-Haenszel||Response rate difference = Upadacitinib (Period 1) - Dupilumab (Period 1)|Upadacitinib (Period 1) vs Dupilumab (Period 1)||20.0|9.4|<0.0001
72451729|NCT05601882|144425741|SUPERIORITY|Analyzed using Cochran-Mantel-Haenszel (CMH) test stratified by Validated Investigator's Global Assessment for Atopic Dermatitis categories \[(vIGA-AD (moderate \[3\] versus severe \[4\])\] and age (12 to \< 18; 18 to \< 40; ≥40 to \< 64 years)|Adjusted Response Rate Difference|16.6|||<|0.0001|TWO_SIDED|95.0|10.2|23.0|||Cochran-Mantel-Haenszel||Response rate difference = Upadacitinib (Period 1) - Dupilumab (Period 1)|Upadacitinib (Period 1) vs Dupilumab (Period 1)||23.0|10.2|<0.0001
72451730|NCT05601882|144425742|SUPERIORITY|Analyzed using Cochran-Mantel-Haenszel (CMH) test stratified by Validated Investigator's Global Assessment for Atopic Dermatitis categories \[(vIGA-AD (moderate \[3\] versus severe \[4\])\] and age (12 to \< 18; 18 to \< 40; ≥40 to \< 64 years)|Adjusted Response Rate Difference|13.2|||<|0.0001|TWO_SIDED|95.0|9.6|16.9|||Cochran-Mantel-Haenszel||Response rate difference = Upadacitinib (Period 1) - Dupilumab (Period 1)|Upadacitinib (Period 1) vs Dupilumab (Period 1)||16.9|9.6|<0.0001
72451731|NCT05601882|144425743|SUPERIORITY|Analyzed using Cochran-Mantel-Haenszel (CMH) test stratified by Validated Investigator's Global Assessment for Atopic Dermatitis categories \[(vIGA-AD (moderate \[3\] versus severe \[4\])\] and age (12 to \< 18; 18 to \< 40; ≥40 to \< 64 years)|Adjusted Response Rate Difference|6.4|||<|0.0001|TWO_SIDED|95.0|3.8|9.1|||Cochran-Mantel-Haenszel||Response rate difference = Upadacitinib (Period 1) - Dupilumab (Period 1)|Upadacitinib (Period 1) vs Dupilumab (Period 1)||9.1|3.8|<0.0001
72451732|NCT05601882|144425744|SUPERIORITY|Analyzed using Cochran-Mantel-Haenszel (CMH) test stratified by Validated Investigator's Global Assessment for Atopic Dermatitis categories \[(vIGA-AD (moderate \[3\] versus severe \[4\])\] and age (12 to \< 18; 18 to \< 40; ≥40 to \< 64 years)|Adjusted Response Rate Difference|14.1|||<|0.0001|TWO_SIDED|95.0|9.4|18.8|||Cochran-Mantel-Haenszel||Response rate difference = Upadacitinib (Period 1) - Dupilumab (Period 1)|Upadacitinib (Period 1) vs Dupilumab (Period 1)||18.8|9.4|<0.0001
72451733|NCT05601882|144425745|SUPERIORITY|Analyzed using Cochran-Mantel-Haenszel (CMH) test stratified by Validated Investigator's Global Assessment for Atopic Dermatitis categories \[(vIGA-AD (moderate \[3\] versus severe \[4\])\] and age (12 to \< 18; 18 to \< 40; ≥40 to \< 64 years)|Adjusted Response Rate Difference|18.6|||<|0.0001|TWO_SIDED|95.0|13.9|23.3|||Cochran-Mantel-Haenszel||Response rate difference = Upadacitinib (Period 1) - Dupilumab (Period 1)|Upadacitinib (Period 1) vs Dupilumab (Period 1)||23.3|13.9|<0.0001
72619876|NCT01539525|144770911|SUPERIORITY_OR_OTHER||Slope|-0.078|STANDARD_ERROR_OF_MEAN|0.02|<|0.001|TWO_SIDED|95.0|-0.118|-0.038|||Generalized Estimating Equation|adjusted for stratifying variables- primary substance and pregnancy status|Parameter estimated is the linear effect of time (in months)|Differences in days/month of primary substance use over time between treatment groups were examined using generalized estimating equations (GEE). We specified a negative binomial distribution to account for overdispersion in days/month of primary substance use, a log link function, and a first-order autoregressive working correlation structure. β coefficients were estimated using quasi-likelihood estimation methods and sandwich/empirical standard errors were calculated.||-0.038|-0.118|<0.001
72622437|NCT02181413|144774851|SUPERIORITY||Hazard Ratio (HR)|0.716||||0.002|TWO_SIDED|95.0|0.579|0.886||P-value was based on log-rank test stratified by pre-induction regimen, ISS stage and response after transplantation.|Log Rank||Hazard ratio is based on an unadjusted Cox's proportional hazard regression model stratified by induction regimen, pre-induction ISS, and response after transplantation, comparing the hazard rate of Ixazomib arm over the hazard rate of Placebo arm.|||0.886|0.579|0.002
72499166|NCT00619957|144528693|SUPERIORITY_OR_OTHER||LS Mean Difference|0.57||||0.1408|TWO_SIDED|95.0|-0.19|1.34|||ANOVA|Fixed effects for treatment and pooled center.||A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.||1.34|-0.19|0.1408
72499167|NCT00619957|144528694|SUPERIORITY_OR_OTHER||LS Mean Difference|1.07||||0.0129|TWO_SIDED|95.0|0.23|1.92|||ANOVA|Fixed effects for treatment and pooled center.||A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.||1.92|0.23|0.0129
72499168|NCT00619957|144528695|SUPERIORITY_OR_OTHER||LS Mean Difference|2.31|||<|0.0001|TWO_SIDED|95.0|1.35|3.26|||ANOVA|Fixed effects for treatment and pooled center.||A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.||3.26|1.35|<0.0001
72499169|NCT00619957|144528696|SUPERIORITY_OR_OTHER||LS Mean Difference|2.15|||<|0.0001|TWO_SIDED|95.0|1.22|3.08|||ANOVA|Fixed effects for treatment and pooled center.||A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.||3.08|1.22|<0.0001
72499170|NCT00619957|144528697|SUPERIORITY_OR_OTHER||LS Mean Difference|-43.6|||<|0.0001|TWO_SIDED|95.0|-51.52|-35.67|||ANOVA|Fixed effects for treatment and pooled center.||A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.||-35.67|-51.52|<0.0001
72499171|NCT00619957|144528698|SUPERIORITY_OR_OTHER||LS Mean Difference|-44.72|||<|0.0001|TWO_SIDED|95.0|-58.01|-31.43|||ANOVA|Fixed effects for treatment and pooled center||A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.||-31.43|-58.01|<0.0001
72499172|NCT00619957|144528699|SUPERIORITY_OR_OTHER||LS Mean Difference|-42.33|||<|0.0001|TWO_SIDED|95.0|-55.99|-28.67|||ANOVA|Fixed effects for treatment and pooled centers.||A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.||-28.67|-55.99|<0.0001
72499173|NCT00619957|144528700|SUPERIORITY_OR_OTHER||LS Mean Difference|-46.55|||<|0.0001|TWO_SIDED|95.0|-59.38|-33.72|||ANOVA|Fixed effects for treatment and pooled center.||A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.||-33.72|-59.38|<0.0001
72499174|NCT00619957|144528701|SUPERIORITY_OR_OTHER||LS Mean Difference|-45.15|||<|0.0001|TWO_SIDED|95.0|-57.01|-33.29|||ANOVA|Fixed effects for treatment and pooled center.||A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.||-33.29|-57.01|<0.0001
72499175|NCT00619957|144528702|SUPERIORITY_OR_OTHER||LS Mean Difference|-15.88|||<|0.0001|TWO_SIDED|95.0|-23.43|-8.32|||ANOVA|Fixed effects for treatment and pooled center.||A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.||-8.32|-23.43|<0.0001
72499176|NCT00619957|144528703|SUPERIORITY_OR_OTHER||LS Mean Difference|-22.0|||<|0.0001|TWO_SIDED|95.0|-31.08|-12.91|||ANOVA|Fixed effects for treatment and pooled center.||A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.||-12.91|-31.08|<0.0001
72391363|NCT03000439|144289799|OTHER||Difference in percentage|4.61|||||TWO_SIDED|95.0|-12.01|21.23|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 16||21.23|-12.01|
72391364|NCT03000439|144289799|OTHER||Difference in percentage|4.61|||||TWO_SIDED|95.0|-12.01|21.23|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 20||21.23|-12.01|
72451734|NCT05601882|144425746|SUPERIORITY|Analyzed using Cochran-Mantel-Haenszel (CMH) test stratified by Validated Investigator's Global Assessment for Atopic Dermatitis categories \[(vIGA-AD (moderate \[3\] versus severe \[4\])\] and age (12 to \< 18; 18 to \< 40; ≥40 to \< 64 years)|Adjusted Response Rate Difference|9.3|||<|0.0001|TWO_SIDED|95.0|5.4|13.1|||Cochran-Mantel-Haenszel||Response rate difference = Upadacitinib (Period 1) - Dupilumab (Period 1)|Upadacitinib (Period 1) vs Dupilumab (Period 1)||13.1|5.4|<0.0001
72451735|NCT04977583|144425817|SUPERIORITY||Odds Ratio (OR)|1.138|STANDARD_ERROR_OF_MEAN|0.2625||0.6243|TWO_SIDED|95.0|0.679|1.904|||Mixed Models Analysis|||This test is comparing Arm 1 (screening) to Arm 2 (awareness)||1.904|0.679|0.6243
72451736|NCT04977583|144425817|SUPERIORITY||Odds Ratio (OR)|1.497|STANDARD_ERROR_OF_MEAN|0.2553||0.1146|TWO_SIDED|95.0|0.908|2.469|||Mixed Models Analysis|||This test compares Arm 1 (screening) to arm 3 (assistance)||2.469|0.908|0.1146
72451737|NCT04977583|144425818|SUPERIORITY||Risk Ratio (RR)|0.963|STANDARD_ERROR_OF_MEAN|0.2078||0.856|TWO_SIDED|95.0|0.641|1.447|||Poisson|We used total needs as an offset||This test is comparing Arm 1 (screening) to Arm 2 (awareness)||1.447|0.641|0.856
72451738|NCT04977583|144425818|SUPERIORITY||Risk Ratio (RR)|1.136|STANDARD_ERROR_OF_MEAN|0.1999||0.5248|TWO_SIDED|95.0|0.768|1.681|||Poisson|||This test is comparing Arm 1 (screening) to Arm 3 (assistance)||1.681|0.768|0.5248
72451739|NCT04977583|144425819|SUPERIORITY||Odds Ratio (OR)|0.866|STANDARD_ERROR_OF_MEAN|0.22||0.5582|TWO_SIDED|95.0|0.536|1.4|||Regression, Logistic|||This is Arm 1 compared to Arm 2||1.400|0.536|.5582
72391365|NCT03000439|144289799|OTHER||Difference in percentage|-8.99|||||TWO_SIDED|95.0|-25.07|7.1|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 24||7.10|-25.07|
72451740|NCT04977583|144425819|SUPERIORITY||Odds Ratio (OR)|0.854|STANDARD_ERROR_OF_MEAN|0.217||0.5196|TWO_SIDED|95.0|0.528|1.381|||Regression, Logistic|||This is Arm 1 compared to Arm 3||1.381|0.528|0.5196
72451741|NCT04977583|144425820|SUPERIORITY||Odds Ratio (OR)|1.42|STANDARD_ERROR_OF_MEAN|0.2794||0.2105|TWO_SIDED|95.0|0.821|2.454|||ANOVA|||This is arm 1 compared to arm 2||2.454|0.821|0.2105
72451742|NCT04977583|144425820|SUPERIORITY||Odds Ratio (OR)|0.7944|STANDARD_ERROR_OF_MEAN|0.2816||0.4143|TWO_SIDED|95.0|0.4574|1.379|||ANOVA|||This is arm 1 compared to arm 3||1.379|0.4574|.4143
72451743|NCT04977583|144425821|SUPERIORITY||Odds Ratio (OR)|0.9995|STANDARD_ERROR_OF_MEAN|0.0171||0.9775|TWO_SIDED|95.0|0.9665|1.0336|||ANOVA|||This arm 1 compared to arm 2||1.0336|0.9665|0.9775
72451744|NCT04977583|144425821|SUPERIORITY||Odds Ratio (OR)|1.017|STANDARD_ERROR_OF_MEAN|0.0176||0.3194|TWO_SIDED|95.0|0.9832|1.0534|||ANOVA|||This arm 1 compared to arm 3||1.0534|0.9832|0.3194
72451745|NCT04977583|144425822|SUPERIORITY||Odds Ratio (OR)|1.0284|STANDARD_ERROR_OF_MEAN|0.1613||0.8623|TWO_SIDED|95.0|0.7497|1.4107|||ANOVA|||This is arm 1 compared to arm 2||1.4107|0.7497|0.8623
72451746|NCT04977583|144425822|SUPERIORITY||Odds Ratio (OR)|1.3701|STANDARD_ERROR_OF_MEAN|0.1626||0.0534|TWO_SIDED|95.0|0.9962|1.8844|||ANOVA|||This is arm 1 compared to arm 3||1.8844|0.9962|0.0534
72451747|NCT04977583|144425823|SUPERIORITY||Odds Ratio (OR)|2.298|STANDARD_ERROR_OF_MEAN|1.464||0.5701|TWO_SIDED|95.0|0.1304|40.5121|||ANOVA|||This is arm 1 compared to arm 2||40.5121|0.1304|0.5701
72451748|NCT04977583|144425823|SUPERIORITY||Odds Ratio (OR)|4.56|STANDARD_ERROR_OF_MEAN|1.467||0.3016|TWO_SIDED|95.0|0.2571|80.8746|||ANOVA|||This is arm 1 compared to arm 3||80.8746|0.2571|0.3016
72451749|NCT04977583|144425824|SUPERIORITY||Odds Ratio (OR)|1.522|STANDARD_ERROR_OF_MEAN|0.2438||0.087|TWO_SIDED|95.0|0.944|2.454|||ANOVA|||This is arm 1 compared to arm 2||2.454|0.944|0.0870
72451750|NCT04977583|144425824|SUPERIORITY||Odds Ratio (OR)|1.85|STANDARD_ERROR_OF_MEAN|0.2897||0.0354|TWO_SIDED|95.0|1.048|3.264|||ANOVA|||This is arm 1 compared to arm 3||3.264|1.048|0.0354
72451751|NCT04977583|144425825|SUPERIORITY||Odds Ratio (OR)|0.618|STANDARD_ERROR_OF_MEAN|0.333||0.3063|TWO_SIDED|95.0|0.246|1.553|||ANOVA|||This is arm 1 compared to arm 2||1.553|0.246|0.3063
72451752|NCT04977583|144425825|SUPERIORITY||Odds Ratio (OR)|0.679|STANDARD_ERROR_OF_MEAN|0.3946||0.4378|TWO_SIDED|95.0|0.256|1.803|||ANOVA|||This is arm 1 compared to arm 3||1.803|.256|.4378
72451753|NCT04977583|144425826|SUPERIORITY||Odds Ratio (OR)|0.5083|STANDARD_ERROR_OF_MEAN|0.8265||0.4134|TWO_SIDED|95.0|0.1006|2.5687|||ANOVA|||This is arm 1 compared to arm 2||2.5687|0.1006|0.4134
72451754|NCT04977583|144425826|SUPERIORITY||Odds Ratio (OR)|1.819|STANDARD_ERROR_OF_MEAN|0.8283||0.4705|TWO_SIDED|95.0|0.3588|9.223|||ANOVA|||This is arm 1 compared to arm 3||9.2230|0.3588|0.4705
72451755|NCT04977583|144425827|SUPERIORITY||Odds Ratio (OR)|1.765|STANDARD_ERROR_OF_MEAN|0.2684||0.0347|TWO_SIDED|95.0|1.044|2.987|||Mixed Models Analysis||This analysis is arm 1 compared to arm 3. Arm 3 is the numerator and arm 1 is the denominator.|||2.987|1.044|0.0347
72451756|NCT04977583|144425828|SUPERIORITY||Odds Ratio (OR)|1.734|STANDARD_ERROR_OF_MEAN|0.3489||0.116|TWO_SIDED|95.0|0.875|3.436|||Mixed Models Analysis||This analysis compares arm 1 to arm 2. Arm 2 is the numerator and Arm 1 is the denominator|||3.436|0.875|0.1160
72451757|NCT04977583|144425828|SUPERIORITY||Odds Ratio (OR)|2.376|STANDARD_ERROR_OF_MEAN|0.3475||0.0134|TWO_SIDED|95.0|1.202|4.695|||Mixed Models Analysis|||||4.695|1.202|0.0134
72451758|NCT04977583|144425829|SUPERIORITY||Odds Ratio (OR)|5.006|STANDARD_ERROR_OF_MEAN|0.617||0.0094|TWO_SIDED|95.0|1.512|16.57|||Mixed Models Analysis||This analysis is arm 1 compared to compared to arm 3. Arm 3 is the numerator and arm 1 is denominator.|||16.570|1.512|0.0094
72451759|NCT04977583|144425829|SUPERIORITY||Odds Ratio (OR)|1.875|STANDARD_ERROR_OF_MEAN|0.6532||0.3377|TWO_SIDED|95.0|0.521|6.746|||Mixed Models Analysis||This is a comparison of arm 1 and arm 2. Arm 2 is the numerator and arm 1 is the denominator.|||6.746|0.521|0.3377
72451760|NCT03373916|144425830|OTHER|||||||0.58|||||||Chi-squared|||||||0.58
72451761|NCT03373916|144425831|OTHER|||||||0.46|||||||Wilcoxon (Mann-Whitney)|||||||0.46
72451762|NCT03373916|144425832|OTHER|||||||0.18|||||||Chi-squared|||||||0.18
72451763|NCT03373916|144425833|OTHER|||||||0.29|||||||Wilcoxon (Mann-Whitney)|||||||0.29
72451764|NCT03373916|144425834|OTHER|||||||0.35|||||||Wilcoxon (Mann-Whitney)|||||||0.35
72451765|NCT04098575|144425853|OTHER||||||<|0.001|||||||Chi-squared|||||||<0.001
72451766|NCT04098575|144425854|OTHER|||||||0.835|||||||Chi-squared|||||||0.835
72451767|NCT04098575|144425855|OTHER||||||<|0.001|||||||Chi-squared|||Antihypertensive drugs||||<0.001
72451768|NCT04098575|144425855|OTHER||||||<|0.001|||||||Chi-squared|||Lipid-lowering agents||||<0.001
72451769|NCT04098575|144425855|OTHER||||||<|0.001|||||||Chi-squared|||Antiplatelet, anticoagulant drugs||||<0.001
72451770|NCT04098575|144425855|OTHER||||||<|0.001|||||||Chi-squared|||Glucose-lowering therapies||||<0.001
72391366|NCT03000439|144289799|OTHER||Difference in percentage|-11.87|||||TWO_SIDED|95.0|-30.52|6.79|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 28||6.79|-30.52|
72391367|NCT03000439|144289799|OTHER||Difference in percentage|-5.07|||||TWO_SIDED|95.0|-24.08|13.94|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 32||13.94|-24.08|
72451771|NCT04098575|144425856|OTHER||||||<|0.001|||||||Chi-squared|||Group: \< 65||||<0.001
72451772|NCT04098575|144425856|OTHER|||||||0.001|||||||Chi-squared|||Group: 65 ≤ 75||||0.001
72391368|NCT03000439|144289799|OTHER||Difference in percentage|-5.41|||||TWO_SIDED|95.0|-22.7|11.87|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 36||11.87|-22.70|
72391369|NCT03000439|144289799|OTHER||Difference in percentage|-11.52|||||TWO_SIDED|95.0|-31.65|8.61|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 40||8.61|-31.65|
72391370|NCT03000439|144289799|OTHER||Difference in percentage|-1.84|||||TWO_SIDED|95.0|-20.16|16.48|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 44||16.48|-20.16|
72391371|NCT03000439|144289799|OTHER||Difference in percentage|-8.64|||||TWO_SIDED|95.0|-26.66|9.38|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 48||9.38|-26.66|
72391372|NCT03000439|144289799|OTHER||Difference in percentage|-5.07|||||TWO_SIDED|95.0|-24.08|13.94|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 52||13.94|-24.08|
72391373|NCT03000439|144289800|OTHER||Difference in percentage|-12.21|||||TWO_SIDED|95.0|-29.08|4.65|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 4||4.65|-29.08|
72391374|NCT03000439|144289800|OTHER||Difference in percentage|-14.75|||||TWO_SIDED|95.0|-35.32|5.83|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 8||5.83|-35.32|
72391375|NCT03000439|144289800|OTHER||Difference in percentage|-8.29|||||TWO_SIDED|95.0|-27.91|11.32|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 12||11.32|-27.91|
72391376|NCT03000439|144289800|OTHER||Difference in percentage|1.73|||||TWO_SIDED|95.0|-17.48|20.93|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 16||20.93|-17.48|
72391377|NCT03000439|144289800|OTHER||Difference in percentage|1.38|||||TWO_SIDED|95.0|-16.15|18.91|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 20||18.91|-16.15|
72451773|NCT04098575|144425856|OTHER||||||<|0.001|||||||Chi-squared|||Group: 75 - 80||||<0.001
72451774|NCT04098575|144425856|OTHER||||||<|0.002|||||||Chi-squared|||Group: \> 80||||<0.002
72451775|NCT04098575|144425857|OTHER||||||<|0.001|||||||Chi-squared|||||||<0.001
72451776|NCT04098575|144425858|OTHER||||||<|0.001|||||||Wilcoxon rank sum test|||||||<0.001
72451777|NCT04098575|144425859|OTHER||||||<|0.001|||||||Wilcoxon rank sum test|||||||<0.001
72451778|NCT04098575|144425860|OTHER|||||||0.475|||||||Wilcoxon rank sum test|||||||0.475
72451779|NCT04098575|144425861|OTHER|||||||0.475|||||||Wilcoxon rank sum test|||||||0.475
72451780|NCT04098575|144425862|OTHER||||||<|0.001|||||||Chi-squared|||Insulin||||<0.001
72391378|NCT03000439|144289800|OTHER||Difference in percentage|-5.41|||||TWO_SIDED|95.0|-22.7|11.87|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 24||11.87|-22.70|
72391379|NCT03000439|144289800|OTHER||Difference in percentage|-11.87|||||TWO_SIDED|95.0|-30.52|6.79|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 28||6.79|-30.52|
72391380|NCT03000439|144289800|OTHER||Difference in percentage|-5.07|||||TWO_SIDED|95.0|-24.08|13.94|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 32||13.94|-24.08|
72391381|NCT03000439|144289800|OTHER||Difference in percentage|-8.64|||||TWO_SIDED|95.0|-26.66|9.38|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 36||9.38|-26.66|
72391382|NCT03000439|144289800|OTHER||Difference in percentage|-11.52|||||TWO_SIDED|95.0|-31.65|8.61|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 40||8.61|-31.65|
72391383|NCT03000439|144289800|OTHER||Difference in percentage|-8.29|||||TWO_SIDED|95.0|-27.91|11.32|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 44||11.32|-27.91|
72391384|NCT03000439|144289800|OTHER||Difference in percentage|-8.29|||||TWO_SIDED|95.0|-27.91|11.32|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 48||11.32|-27.91|
72451781|NCT04098575|144425862|OTHER||||||<|0.001|||||||Chi-squared|||Metformin||||<0.001
72451782|NCT04098575|144425862|OTHER|||||||0.157|||||||Chi-squared|||Acarbose||||0.157
72451783|NCT04098575|144425862|OTHER||||||<|0.001|||||||Chi-squared|||Sulfonylurea||||<0.001
72451784|NCT04098575|144425862|OTHER|||||||0.071|||||||Chi-squared|||Dipeptidyl peptidase-4 (DPP-4) inhibitors||||0.071
72451785|NCT04098575|144425862|OTHER|||||||0.317|||||||Chi-squared|||Glucagon-like peptide-1 (GLP-1) agonists||||0.317
72451786|NCT04098575|144425862|OTHER||||||<|0.001|||||||Chi-squared|||Sodium-glucose transport protein-2 (SGLT2) inhibitors other than empagliflozin||||<0.001
72451787|NCT04098575|144425863|OTHER||||||<|0.002|||||||Chi-squared|||||||<0.002
72451788|NCT04098575|144425866|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.000
72391385|NCT03000439|144289800|OTHER||Difference in percentage|-5.07|||||TWO_SIDED|95.0|-24.08|13.94|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 52||13.94|-24.08|
72391386|NCT03000439|144289803|OTHER||Difference in percentage|-8.99|||||TWO_SIDED|95.0|-25.07|7.1|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 4||7.10|-25.07|
72562025|NCT01801917|144655163|SUPERIORITY_OR_OTHER_LEGACY||Bayesian|0.022||||||||||||||It was a Bayesian analysis with non-informative prior for co-primary endpoints, MMT-24 and CK, with dual criteria for statistical significance: ≥ 90% posterior probability (PP) of achieving an increase from baseline in MMT24 and decrease in CK and clinical relevance: ≥ 50% PP achieving an increase of 15 points in MMT24 and a decrease of 30% in CK vs. placebo. . For this table the value is the PP of achieving an increase of 15 points in MMT24 and a decrease of 30% in CK in 2mg group vs. placebo||||
72562026|NCT01801917|144655163|SUPERIORITY_OR_OTHER_LEGACY||Bayesian|0.963||||||||||||||It was a Bayesian analysis with non-informative prior for co-primary endpoints, MMT-24 and CK, with dual criteria for statistical significance: ≥ 90% posterior probability (PP) of achieving an increase from baseline in MMT24 and decrease in CK and clinical relevance: ≥ 50% PP achieving an increase of 15 points in MMT24 and a decrease of 30% in CK vs. placebo. For this table the value is the posterior probability of achieving an increase in MMT24 and a decrease in CK in 10mg group vs. placebo||||
72562027|NCT01801917|144655163|SUPERIORITY_OR_OTHER_LEGACY||Bayesian|0.837||||||||||||||It was a Bayesian analysis with non-informative prior for co-primary endpoints, MMT-24 and CK, with dual criteria for statistical significance: ≥ 90% posterior probability (PP) of achieving an increase from baseline in MMT24 and decrease in CK and clinical relevance: ≥ 50% PP achieving an increase of 15 points in MMT24 and a decrease of 30% in CK vs. placebo. . For this table the value is the PP of achieving an increase of 15 points in MMT24 and a decrease of 30% in CK in 10mg group vs. placebo||||
72562028|NCT04381481|144655182|SUPERIORITY||||||<|0.001||||||The a priori threshold for statistical significance is \< 0.05.|Regression, Logistic|||beverages with claim compared to control beverage||||<0.001
72562029|NCT04381481|144655183|SUPERIORITY||||||<|0.001||||||The a priori threshold for statistical significance is \< 0.05.|Regression, Logistic|||snacks with warning compared to control snack||||<0.001
72562030|NCT04381481|144655184|SUPERIORITY||||||<|0.001||||||The a priori threshold for statistical significance is \< 0.05.|Regression, Logistic|||beverages with claim compared to control beverage||||<0.001
72391387|NCT03000439|144289803|OTHER||Difference in percentage|-19.01|||||TWO_SIDED|95.0|-35.25|-2.76|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 8||-2.76|-35.25|
72391388|NCT03000439|144289803|OTHER||Difference in percentage|-15.44|||||TWO_SIDED|95.0|-32.98|2.1|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 12||2.10|-32.98|
72391389|NCT03000439|144289803|OTHER||Difference in percentage|-12.56|||||TWO_SIDED|95.0|-27.22|2.1|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 16||2.10|-27.22|
72451789|NCT00195403|144425890|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||t-test, 2 sided|||Change from baseline in PGA at Month 3 was evaluated using paired t-test.||||<0.0001
72451790|NCT00195403|144425891|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||t-test, 2 sided|||Change from baseline in number of joints with tenderness, pain, and limitation of motion or swelling at Month 3 were evaluated using paired t-test.||||<0.0001
72451791|NCT05288348|144425904|SUPERIORITY||Mean Difference (Final Values)|2.57||||0.56|TWO_SIDED|95.0|-6.19|11.33||unadjusted|Mixed Models Analysis|Mixed methods ANOVA||||11.33|-6.19|0.56
72451792|NCT05288348|144425904|SUPERIORITY||Mean Difference (Final Values)|-0.51||||0.92|TWO_SIDED|95.0|-10.5|9.48|||Mixed Models Analysis|Mixed methods ANOVA||Adjusted for age, sex, respiratory rate and injury type||9.48|-10.5|0.92
72451793|NCT05288348|144425905|SUPERIORITY||Mean Difference (Final Values)|-7.14||||0.18|TWO_SIDED|95.0|-17.66|3.37|||Mixed Models Analysis|Mixed effects ANOVA||VNRS @ 60min||3.37|-17.66|0.18
72451794|NCT05288348|144425905|SUPERIORITY||Median Difference (Final Values)|2.92||||0.63|TWO_SIDED|95.0|-9.3|15.1|||Mixed Models Analysis|Mixed effects ANOVA||VNRS @ 60 min Adjusted for sex and injury type||15.10|-9.30|0.63
72451795|NCT05288348|144425905|SUPERIORITY||Mean Difference (Final Values)|-10.59||||0.08|TWO_SIDED|95.0|-22.39|1.21||Unadjusted|Mixed Models Analysis|||VNRS @ 90 min||1.21|-22.39|0.08
72451796|NCT05288348|144425905|SUPERIORITY||Mean Difference (Final Values)|7.36||||0.28|TWO_SIDED|95.0|-6.13|20.8|||Mixed Models Analysis|Mixed Method ANOVA|Adjusted for ISS|VNRS @90min adjusted||20.80|-6.13|0.28
72451797|NCT05288348|144425905|SUPERIORITY||Mean Difference (Final Values)|-9.52||||0.18|TWO_SIDED|95.0|-23.6|4.56|||Mixed Models Analysis|||VNRS @ 120 min||4.56|-23.60|0.18
72451798|NCT05288348|144425905|SUPERIORITY||Mean Difference (Final Values)|-5.24||||0.5|TWO_SIDED|95.0|-20.7|10.2|||Mixed Models Analysis|Mixed Method ANOVA||VNRS @ 120min adjusted for sex, HR, RR, and injury type||10.20|-20.70|0.50
72451799|NCT05288348|144425906|SUPERIORITY|||||||0.005||||||PGA @ 30 min|Chi-squared|||||||0.005
72451800|NCT05288348|144425907|SUPERIORITY||Odds Ratio (OR)|1.45||||0.39|TWO_SIDED|95.0|-4.77|1.89|||General Addative Model|||"SPID 30~last observation carried forward (LOCF) imputation technique to fill out the missing values by carrying forward the last observed value"||1.89|-4.77|0.39
72451801|NCT05288348|144425907|SUPERIORITY||Odds Ratio (OR)|1.72||||0.29|TWO_SIDED|95.0|-1.5|4.95|||General Additive Model|||"SPID 30, Adjusted Analysis~last observation carried forward (LOCF) imputation technique to fill out the missing values by carrying forward the last observed value"||4.95|-1.50|0.29
72451802|NCT05288348|144425907|SUPERIORITY||Odds Ratio (OR)|0.08||||0.98|TWO_SIDED|95.0|-6.63|6.47|||Generalized Additive Model|||SPID @ 60min last observation carried forward (LOCF) imputation technique to fill out the missing values by carrying forward the last observed value||6.47|-6.63|0.98
72451803|NCT05288348|144425907|SUPERIORITY||Odds Ratio (OR)|0.61||||0.85|TWO_SIDED|95.0|-5.76|6.98|||Generalized Additive Model|||"SPID 60 Adjusted~Last observed carried forward to address missingness"||6.98|-5.76|0.85
72451804|NCT05288348|144425907|SUPERIORITY||Odds Ratio (OR)|-1.26||||0.8|TWO_SIDED|95.0|-8.75|11.28|||Generalized Additive Model|||SPID @ 90 mn last observation carried forward (LOCF) imputation technique to fill out the missing values by carrying forward the last observed value||11.28|-8.75|0.8
72619877|NCT01539525|144770911|SUPERIORITY_OR_OTHER||Slope|0.005|STANDARD_ERROR_OF_MEAN|0.003||0.066|TWO_SIDED|95.0|-0.0004|0.011|||Generalized Estimating Equation|adjusted for stratifying variables- primary substance and pregnancy status|Parameter estimated is the quadratic effect of time (in months)|Differences in days/month of primary substance use over time between treatment groups were examined using generalized estimating equations (GEE). We specified a negative binomial distribution to account for overdispersion in days/month of primary substance use, a log link function, and a first-order autoregressive working correlation structure. β coefficients were estimated using quasi-likelihood estimation methods and sandwich/empirical standard errors were calculated.||0.011|-0.0004|0.066
72391390|NCT03000439|144289803|OTHER||Difference in percentage|-8.99|||||TWO_SIDED|95.0|-25.07|7.1|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 20||7.10|-25.07|
72391391|NCT03000439|144289803|OTHER||Difference in percentage|-12.21|||||TWO_SIDED|95.0|-29.08|4.65|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 24||4.65|-29.08|
72391392|NCT03000439|144289803|OTHER||Difference in percentage|-8.64|||||TWO_SIDED|95.0|-26.66|9.38|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 28||9.38|-26.66|
72391393|NCT03000439|144289803|OTHER||Difference in percentage|-8.64|||||TWO_SIDED|95.0|-26.66|9.38|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 32||9.38|-26.66|
72391394|NCT03000439|144289803|OTHER||Difference in percentage|-1.84|||||TWO_SIDED|95.0|-20.16|16.48|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 36||16.48|-20.16|
72391395|NCT03000439|144289803|OTHER||Difference in percentage|-4.72|||||TWO_SIDED|95.0|-25.17|15.72|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 40||15.72|-25.17|
72391396|NCT03000439|144289803|OTHER||Difference in percentage|-8.29|||||TWO_SIDED|95.0|-27.91|11.32|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 44||11.32|-27.91|
72391397|NCT03000439|144289803|OTHER||Difference in percentage|-4.72|||||TWO_SIDED|95.0|-25.17|15.72|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 48||15.72|-25.17|
72391398|NCT03000439|144289803|OTHER||Difference in percentage|2.07|||||TWO_SIDED|95.0|-18.53|22.68|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 52||22.68|-18.53|
72391399|NCT00592384|144289804|SUPERIORITY_OR_OTHER||||||<|0.025||||||Bonferroni corrected for two primary comparisons|Mixed Models Analysis|see above||Primary analyses included observations at baseline, 1, 3, 6, 8, 10, and 12 weeks. Random effects were included for participants' intercepts. Fixed effects were time (linear), treatment (VFN vs. PBO), interaction of time with treatment, stratification factors and potential confounders and variables to improve sensitivity. The primary indicator of treatment effect was the interaction of time by treatment.||||<.025
72391400|NCT00592384|144289817|SUPERIORITY_OR_OTHER||||||<|0.025||||||Bonferroni corrected for two primary outcomes|Mixed Models Analysis|||Primary analyses included observations at baseline, 1, 3, 6, 8, 10, and 12 weeks. Random effects were included for participants' intercepts. Fixed effects were time (linear), treatment (VFN vs. PBO), interaction of time with treatment, stratification factors and potential confounders and variables to improve sensitivity. The primary indicator of treatment effect was the interaction of time by treatment.||||<.025
72391401|NCT00964860|144289847|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.24|STANDARD_ERROR_OF_MEAN|0.05||0.001|ONE_SIDED|95.0||||a priori threshold for statistical significance = 0.05|ANCOVA||All treatment comparisons were 1-sided with the significance level set at 5%. Units on the MGI Scale.|||||0.001
72391402|NCT00964860|144289848|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|0.05||0.004|ONE_SIDED|95.0||||a priori threshold for statistical significance = 0.05|ANCOVA||All treatment comparisons were 1-sided with the significance level set at 5%|||||0.004
72391403|NCT03716024|144289849|SUPERIORITY||Mean Difference (Final Values)|13.6|||||TWO_SIDED|95.0|1.3|26.0|||||omadacycline minus linezolid|||26.0|1.3|
72391404|NCT03716024|144289850|SUPERIORITY||Mean Difference (Final Values)|4.8|||||TWO_SIDED|95.0|-1.7|11.4|||||omadacycline minus linezolid|||11.4|-1.7|
72391405|NCT03716024|144289851|SUPERIORITY||Mean Difference (Final Values)|13.8|||||TWO_SIDED|95.0|0.9|26.7|||||omadacycline minus linezolid|||26.7|0.9|
72391406|NCT03716024|144289852|SUPERIORITY||Mean Difference (Final Values)|4.3|||||TWO_SIDED|95.0|-5.3|14.0||||||||14.0|-5.3|
72391407|NCT05275400|144289881|NON_INFERIORITY|Noninferiority margin (NIM) was 0.4%|LS Mean Difference|-0.089|||||TWO_SIDED|95.0|-0.191|0.013||||||||0.013|-0.191|
72391408|NCT05275400|144289882|SUPERIORITY||LS Mean Difference|-0.089||||0.088|TWO_SIDED|95.0|-0.191|0.013|||ANCOVA|||||0.013|-0.191|0.088
72391409|NCT05275400|144289883|SUPERIORITY||Relative rate|1.03||||0.897|TWO_SIDED|95.0|0.62|1.74|||Negative binomial model|||||1.74|0.62|0.897
72391410|NCT05275400|144289884|SUPERIORITY||LS Mean Difference|0.42||||0.722|TWO_SIDED|95.0|-1.88|2.72|||ANCOVA|||||2.72|-1.88|0.722
72391411|NCT05275400|144289885|SUPERIORITY||LS Mean Difference|-0.84||||0.605|TWO_SIDED|95.0|-4.01|2.33|||ANCOVA|||||2.33|-4.01|0.605
72391412|NCT05275400|144289886|SUPERIORITY||LS Mean Difference|-30.0||||0.003|TWO_SIDED|95.0|-50.1|-9.97|||Mixed Models Analysis|||||-9.97|-50.10|0.003
72391413|NCT05275400|144289887|SUPERIORITY||Relative rate|1.14||||0.43|TWO_SIDED|95.0|0.83|1.56|||Negative binomial model|||||1.56|0.83|0.430
72391414|NCT05275400|144289888|SUPERIORITY||LS Mean Difference|0.071||||0.756|TWO_SIDED|95.0|-0.38|0.52|||Mixed Models Analysis|||||0.52|-0.38|0.756
72391415|NCT05275400|144289889|SUPERIORITY||LS Mean Difference|0.14||||0.021|TWO_SIDED|95.0|0.02|0.27|||ANCOVA|||||0.27|0.02|0.021
72391416|NCT05275400|144289890|SUPERIORITY||LS Mean Difference|-0.99||||0.417|TWO_SIDED|95.0|-3.37|1.4|||ANCOVA|||||1.40|-3.37|0.417
72391417|NCT05275400|144289891|SUPERIORITY||LS Mean Difference|3.15|||<|0.001|TWO_SIDED|95.0|1.71|4.59|||Mixed Models Analysis|||Week 26||4.59|1.71|<0.001
72391418|NCT05275400|144289891|SUPERIORITY||LS Mean Difference|3.56|||<|0.001|TWO_SIDED|95.0|2.05|5.07|||Mixed Models Analysis|||Week 52||5.07|2.05|<0.001
72391419|NCT05275400|144289891|SUPERIORITY||LS Mean Difference|3.35|||<|0.001|TWO_SIDED|95.0|1.75|4.94|||Mixed Models Analysis|||Week 78||4.94|1.75|<0.001
72391420|NCT02585960|144289895|SUPERIORITY||Gaussian Statistic estimate|1.96||||0.0545|TWO_SIDED|95.0|-0.038|3.958|||Chi-squared||Approximately Gaussian Statistic is obtained by taking the square root of the Chi-squared test with continuity adjustment.|The proportion of participants with an ABR of 0 during the second 6-month period on BAX 855 prophylaxis, was compared between the 2 prophylaxis arms using a chi-square test with continuity correction at a 2-sided 5% level of significance.||3.958|-0.038|0.0545
72451805|NCT05288348|144425907|SUPERIORITY||Odds Ratio (OR)|-0.44||||0.92|TWO_SIDED|95.0|-10.2|9.92|||Generalized Additive Model|||"SPID 90 min Adjusted~last observation carried forward (LOCF) imputation technique to fill out the missing values by carrying forward the last observed value"||9.92|-10.2|0.92
72391421|NCT00044083|144289955|OTHER||||||<|0.0001||||||Diagnosis effect on placebo|ANOVA|||||||<0.0001
72391422|NCT00044083|144289955|OTHER|||||||0.0034||||||Drug Effect on Patients|ANOVA|||||||0.0034
72391423|NCT00044083|144289956|OTHER||||||<|0.0001||||||Diagnosis Effect on Placebo in right DLPFC|ANOVA|||||||<0.0001
72451806|NCT05288348|144425907|SUPERIORITY||Odds Ratio (OR)|-3.18||||0.64|TWO_SIDED|95.0|-10.45|16.9|||Generalized Additive Model|||SPID @ 120 min last observation carried forward (LOCF) imputation technique to fill out the missing values by carrying forward the last observed value||16.90|-10.45|0.64
72451807|NCT05288348|144425907|SUPERIORITY||Odds Ratio (OR)|-2.15||||0.75|TWO_SIDED|95.0|-15.6|11.3|||Generalized Additive Model|||"SPID 120 Adjusted~last observation carried forward (LOCF) imputation technique to fill out the missing values by carrying forward the last observed value"||11.30|-15.60|0.75
72451808|NCT05288348|144425908|SUPERIORITY||z statistic|0.46||||0.64|TWO_SIDED|95.0|-1.96|1.96|||two sided test of proportion|||||1.96|-1.96|0.64
72451809|NCT05288348|144425909|SUPERIORITY||Odds Ratio (OR)|-0.22||||0.61|TWO_SIDED|95.0|-1.11|0.66|||General Additive Models|||||0.66|-1.11|0.61
72451810|NCT05288348|144425909|SUPERIORITY||Odds Ratio (OR)|-0.28||||0.54|TWO_SIDED|95.0|-1.23|0.65|||General Additive Model|||6 item screener adjusted analysis||0.65|-1.23|0.54
72451811|NCT05288348|144425910|SUPERIORITY||Odds Ratio (OR)|2.35||||0.009|TWO_SIDED|95.0|1.24|4.46|||Ordinal Polytomous Logisitic Regression|||Healthcare Professional Global Assessment of method of pain control at 30 min.||4.46|1.24|0.009
72451812|NCT05288348|144425910|SUPERIORITY||Odds Ratio (OR)|2.24||||0.01|TWO_SIDED|95.0|1.18|4.29|||Ordinal polytomous logistic regression|||Healthcare Professional Global Assessment of method of pain control at 30 min. adjusted for ISS and Race||4.29|1.18|0.01
72391424|NCT00044083|144289956|OTHER|||||||0.014||||||Diagnosis Effect of Placebo in left DLPFC|ANOVA|||||||0.014
72391425|NCT00044083|144289957|OTHER|||||||0.05||||||Drug Effect across both groups in left DLPFC|ANOVA|||||||0.05
72391426|NCT00044083|144289957|OTHER|||||||0.32||||||Drug Effect across both groups in right DLPFC|ANOVA|||||||0.32
72391427|NCT00044083|144289958|OTHER|||||||0.05||||||The Effect of Drug on Patients with Schizophrenia in right DLPFC|t-test, 1 sided|||||||0.05
72391428|NCT00044083|144289958|OTHER|||||||0.078||||||Effect of Drug on Patients with Schizophrenia in left DLPFC|t-test, 1 sided|||||||0.078
72391429|NCT00044083|144289959|OTHER|||||||0.05||||||Drug Effect on Healthy Volunteers in left DLPFC|t-test, 1 sided|||||||0.05
72391430|NCT00044083|144289959|OTHER|||||||0.73||||||Drug Effect on Healthy Volunteers in right DLPFC|t-test, 1 sided|||||||0.73
72391431|NCT00044083|144289960|OTHER||||||<|0.0001|||||||ANOVA|Main Effect of Genotype across both Placebo and Tolcapone in right DLPFC||||||<0.0001
72391432|NCT00044083|144289960|OTHER|||||||0.167|||||||ANOVA|Main Effect of Genotype across both Placebo and Tolcapone in left DLPFC||||||0.167
72391433|NCT00044083|144289961|OTHER|||||||0.189||||||Drug by Genotype Effect in left DLPFC|ANOVA|||||||0.189
72391434|NCT00044083|144289961|OTHER|||||||0.041||||||Drug Effect on Val/Val Genotype in left DLPFC|t-test, 1 sided|||||||0.041
72391435|NCT00044083|144289961|OTHER|||||||0.718||||||Drug Effect on Val/Met Genotype in left DLPFC|t-test, 1 sided|||||||0.718
72391436|NCT00044083|144289961|OTHER|||||||0.469||||||Drug Effect of Met/Met Genotype in left DLPFC|t-test, 1 sided|||||||0.469
72391437|NCT00044083|144289962|OTHER|||||||0.7||||||Drug Effect on Positive Syndrome for Patients|t-test, 1 sided|||||||0.7
72391438|NCT00044083|144289962|OTHER|||||||0.4||||||Drug Effect on Negative Syndrome for Patients|t-test, 1 sided|||||||0.4
72391439|NCT00044083|144289962|OTHER|||||||0.12||||||Drug Effect on General Pathology for Patients|t-test, 1 sided|||||||0.12
72391440|NCT01619423|144289963|SUPERIORITY||Odds Ratio (OR)|0.78||||0.31|ONE_SIDED|10.0||1.5|||Cochran-Mantel-Haenszel|||||1.5||0.31
72451813|NCT05288348|144425911|SUPERIORITY||Odds Ratio (OR)|0.97||||0.96|TWO_SIDED|95.0|0.22|4.26|||Regression, Logistic|||||4.26|0.22|0.96
72451814|NCT05288348|144425911|SUPERIORITY||Odds Ratio (OR)|0.94|||||TWO_SIDED|95.0|0.17|5.04|||||Adjusted for age, sex and SpO2|||5.04|0.17|
72451815|NCT05288348|144425912|SUPERIORITY||Odds Ratio (OR)|0.97|||||TWO_SIDED|95.0|0.04|24.92||||||||24.92|0.04|
72451816|NCT05288348|144425912|SUPERIORITY||Odds Ratio (OR)|0.2|||||TWO_SIDED|95.0|0.0|14.28|||||Adjusted for Heart Rate and Injury Severity Score|||14.28|0|
72451817|NCT05288348|144425913|SUPERIORITY||Odds Ratio (OR)|1.67|||||TWO_SIDED|95.0|0.39|8.37||||||||8.37|0.39|
72451818|NCT05288348|144425913|SUPERIORITY||Odds Ratio (OR)|1.68|||||TWO_SIDED|95.0|0.39|8.6|||||Adjusted for SpO2|||8.60|0.39|
72451819|NCT05288348|144425915|SUPERIORITY||Odds Ratio (OR)|0.48|||||TWO_SIDED|95.0|0.02|5.12||||||||5.12|0.02|
72451820|NCT05288348|144425915|SUPERIORITY||Odds Ratio (OR)|0.41|||||TWO_SIDED|95.0|0.02|4.56|||||Adjusted for heart rate|||4.56|0.02|
72451821|NCT05288348|144425916|SUPERIORITY||difference of proportion|0.135|||>|0.99|TWO_SIDED||||||Chi-squared|||||||>0.99
72451822|NCT05288348|144425917|SUPERIORITY||Hazard Ratio (HR)|1.05||||0.9|TWO_SIDED|95.0|0.69|1.61|||Regression, Cox|||||1.61|0.69|0.90
72451823|NCT05288348|144425917|SUPERIORITY||Hazard Ratio (HR)|1.16||||0.48|TWO_SIDED|95.0|0.75|1.81|||Regression, Cox|||Adjusted for Race and ISS||1.81|0.75|0.48
72451824|NCT05288348|144425919|SUPERIORITY||Odds Ratio (OR)|0.0||||0.99|TWO_SIDED|95.0|-0.15|0.15|||Non parametric General Addative Model|||||0.15|-0.15|0.99
72451825|NCT05288348|144425919|SUPERIORITY||Odds Ratio (OR)|0.01||||0.96|TWO_SIDED|95.0|-0.16|0.15|||Non Parametric General Additive Model|||Adjusted||0.15|-0.16|0.96
72451826|NCT05288348|144425920|SUPERIORITY||Odds Ratio (OR)|0.01||||0.84|TWO_SIDED|95.0|-0.17|0.16|||Non Parametric General Additive Model|||||0.16|-0.17|0.84
72451827|NCT05288348|144425920|SUPERIORITY||Odds Ratio (OR)|0.02||||0.84|TWO_SIDED|95.0|-0.19|0.16|||Non Parametric Generalized Additive Mode|||Adjusted||0.16|-0.19|0.84
72451828|NCT05288348|144425921|SUPERIORITY||Odds Ratio (OR)|0.02||||0.81|TWO_SIDED|95.0|-0.17|0.22|||Non Parametric Generalized Additive Mode|||||0.22|-0.17|0.81
72451829|NCT05288348|144425921|SUPERIORITY||Odds Ratio (OR)|0.01||||0.91|TWO_SIDED|95.0|-0.2|0.22|||Non Parametric Generalized Additive Mode|||Adjusted||0.22|-0.20|0.91
72451830|NCT05288348|144425922|SUPERIORITY||Odds Ratio (OR)|0.03||||0.74|TWO_SIDED|95.0|-0.25|0.18|||Non Parametric Generalized Additive Mode|||||0.18|-0.25|0.74
72451831|NCT05288348|144425922|SUPERIORITY||Odds Ratio (OR)|0.05||||0.63|TWO_SIDED|95.0|-0.3|0.18|||Non Parametric Generalized Additive Mode|||Adjusted||0.18|-0.30|0.63
72451832|NCT06688357|144425927|SUPERIORITY||Cohen's d|0.99||||0.077|TWO_SIDED|||||t (13) = 1.920. Only 1 comparison with 2 means, thus no adjustment necessary|t-test, 2 sided|||Independent sample t-test conducted to examine difference in pre-post intervention change scores for the active vs sham intervention groups. Cohen's d was calculated to determine effect size.||||.077
72451833|NCT06688357|144425928|SUPERIORITY||Cohen's D|0.779||||0.159|TWO_SIDED|||||t(13) = 1.504; only 1 comparison of 2 values, thus no adjustment is necessary|t-test, 2 sided|||independent sample t-test; Cohen's d effect size||||.159
72451834|NCT06688357|144425929|SUPERIORITY||Cohen's D|0.356||||0.503|TWO_SIDED|||||t (13) = 0.688; only 1 comparison, adjustment not necessary|t-test, 2 sided|df = 13||independent samples t-test, cohen's d effect size||||.503
72451835|NCT06688357|144425930|SUPERIORITY||Cohen's D|-0.922||||0.08|TWO_SIDED|||||t(13) = 1.893; only one comparison of 2 scores, thus no adjustment for multiple comparisons was necessary|t-test, 2 sided|df = 13||Independent sample t-test used to examine pre-post intervention change scores in active vs sham groups; Cohen's d was calculated to estimate effect size||||0.08
72451836|NCT06688357|144425931|SUPERIORITY||Cohen's D|0.793||||0.149|TWO_SIDED|||||t (13) = 1.533; only 1 comparison, no adjustment necessary|t-test, 2 sided|||independent sample t-test, Cohen d effect size||||.149
72451837|NCT06688357|144425932|SUPERIORITY||Cohen's D|0.905||||0.104|TWO_SIDED|||||t(13) = 1.749; only 1 comparison with 2 values, thus no adjustment for multiple comparisons|t-test, 2 sided|df = 13||independent sample t-test was used to examine difference in Post-Pre intervention change in the Active vs the Sham groups; Effect size was estimated using Cohen's d.||||.104
72451838|NCT06688357|144425933|SUPERIORITY||Cohen's D|-0.267||||0.614|TWO_SIDED|||||t(13) = -.516; only 1 comparison of 2 means, no adjustment needed|t-test, 2 sided|||independent sample t-tests examining Post-Baseline differences for the Active vs the Sham groups; Effect size computed using Cohen's d score||||.614
72451839|NCT06688357|144425934|SUPERIORITY||Cohen's D|0.652||||0.23|TWO_SIDED|||||t(13) = -1.260; only 1 comparison of 2 values, no need for adjustment|t-test, 2 sided|||independent samples t-test, effect size computation (cohen's d)||||.230
72451840|NCT04121741|144425935|SUPERIORITY||Mean Difference (Final Values)|-0.07|STANDARD_ERROR_OF_MEAN|0.42||0.864|TWO_SIDED|||||Using Bonferroni correction for 3 primary outcomes (FMD, RHI, fRHI), a priori threshold for statistical significance was p\<0.0167.|Regression, Linear|Included outlier detection and removal with estimation of standard models for a three-treatment, cross-over design.|Estimated mean difference for FMD% (singing video intervention compared to control) is shown. Estimates of FMD% for singing coach intervention compared to control also performed.||"Please reference the following pre-print manuscript for additional statistical analyses.~Bagherimohamadipour M, Hammad M, Visotcky A, Sparapani R, Kulinski J. Effects of Singing on Vascular Health in Older Adults with Coronary Artery Disease: A Randomized Trial. medRxiv \[Preprint\]. 2024 Jul 27:2024.07.25.24311033. doi: 10.1101/2024.07.25.24311033. PMID: 39108506; PMCID: PMC11302710."|||0.864
72451841|NCT04121741|144425935|SUPERIORITY||Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.42||0.913|TWO_SIDED|||||Using Bonferroni correction for 3 primary outcomes (FMD, RHI, fRHI), a priori threshold for statistical significance was p\<0.0167.|Regression, Linear|Included outlier detection and removal with estimation of standard models for a three-treatment, cross-over design.|Estimated mean difference for FMD% (singing coach intervention compared to control) is shown. Estimates of FMD% for singing video intervention compared to control also performed.||"Please reference the following pre-print manuscript for additional statistical analyses.~Bagherimohamadipour M, Hammad M, Visotcky A, Sparapani R, Kulinski J. Effects of Singing on Vascular Health in Older Adults with Coronary Artery Disease: A Randomized Trial. medRxiv \[Preprint\]. 2024 Jul 27:2024.07.25.24311033. doi: 10.1101/2024.07.25.24311033. PMID: 39108506; PMCID: PMC11302710."|||0.913
72451842|NCT04121741|144425936|SUPERIORITY||Mean Difference (Final Values)|0.13|STANDARD_ERROR_OF_MEAN|0.13||0.29|TWO_SIDED|||||Using Bonferroni correction for 3 primary outcomes (FMD, RHI, fRHI), a priori threshold for statistical significance was p\<0.0167.|Regression, Linear|Included outlier detection and removal with estimation of standard models for a three-treatment, cross-over design.|Estimated mean difference for RHI (singing video intervention compared to control) is shown. Estimates of RHI for singing coach intervention compared to control also performed.||"Please reference the following pre-print manuscript for additional statistical analyses.~Bagherimohamadipour M, Hammad M, Visotcky A, Sparapani R, Kulinski J. Effects of Singing on Vascular Health in Older Adults with Coronary Artery Disease: A Randomized Trial. medRxiv \[Preprint\]. 2024 Jul 27:2024.07.25.24311033. doi: 10.1101/2024.07.25.24311033. PMID: 39108506; PMCID: PMC11302710."|||0.290
72499177|NCT00619957|144528704|SUPERIORITY_OR_OTHER||LS Mean Difference|-21.96|||<|0.0001|TWO_SIDED|95.0|-30.75|-13.17|||ANOVA|Fixed effects for treatment and pooled center.||A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.||-13.17|-30.75|<0.0001
72562031|NCT04381481|144655185|SUPERIORITY||||||<|0.001||||||The a priori threshold for statistical significance is \< 0.05.|Regression, Logistic|||beverages with claim compared to control beverage||||<0.001
72391441|NCT01619423|144289963|SUPERIORITY||Odds Ratio (OR)|0.55||||0.15|ONE_SIDED|10.0||1.16|||Cochran-Mantel-Haenszel|||||1.16||0.15
72451843|NCT04121741|144425936|SUPERIORITY||Mean Difference (Final Values)|0.09|STANDARD_ERROR_OF_MEAN|0.12||0.462|TWO_SIDED|||||Using Bonferroni correction for 3 primary outcomes (FMD, RHI, fRHI), a priori threshold for statistical significance was p\<0.0167.|Regression, Linear|Included outlier detection and removal with estimation of standard models for a three-treatment, cross-over design.|Estimated mean difference for RHI (singing coach intervention compared to control) is shown. Estimates of RHI for singing video intervention compared to control also performed.||"Please reference the following pre-print manuscript for additional statistical analyses.~Bagherimohamadipour M, Hammad M, Visotcky A, Sparapani R, Kulinski J. Effects of Singing on Vascular Health in Older Adults with Coronary Artery Disease: A Randomized Trial. medRxiv \[Preprint\]. 2024 Jul 27:2024.07.25.24311033. doi: 10.1101/2024.07.25.24311033. PMID: 39108506; PMCID: PMC11302710."|||0.462
72451844|NCT04121741|144425937|SUPERIORITY||Mean Difference (Final Values)|0.54|STANDARD_ERROR_OF_MEAN|0.19||0.005|TWO_SIDED|||||Using Bonferroni correction for 3 primary outcomes (FMD, RHI, fRHI), a priori threshold for statistical significance was p\<0.0167.|Regression, Linear|Included outlier detection and removal with estimation of standard models for a three-treatment, cross-over design.|Estimated mean difference for fRHI (singing video intervention compared to control) is shown. Estimates of fRHI for singing coach intervention compared to control also performed.||"Please reference the following pre-print manuscript for additional statistical analyses.~Bagherimohamadipour M, Hammad M, Visotcky A, Sparapani R, Kulinski J. Effects of Singing on Vascular Health in Older Adults with Coronary Artery Disease: A Randomized Trial. medRxiv \[Preprint\]. 2024 Jul 27:2024.07.25.24311033. doi: 10.1101/2024.07.25.24311033. PMID: 39108506; PMCID: PMC11302710."|||0.005
72451845|NCT04121741|144425937|SUPERIORITY||Mean Difference (Final Values)|0.11|STANDARD_ERROR_OF_MEAN|0.18||0.57|TWO_SIDED|||||Using Bonferroni correction for 3 primary outcomes (FMD, RHI, fRHI), a priori threshold for statistical significance was p\<0.0167.|Regression, Linear|Included outlier detection and removal with estimation of standard models for a three-treatment, cross-over design.|Estimated mean difference for fRHI (singing coach intervention compared to control) is shown. Estimates of fRHI for singing video intervention compared to control also performed.||"Please reference the following pre-print manuscript for additional statistical analyses.~Bagherimohamadipour M, Hammad M, Visotcky A, Sparapani R, Kulinski J. Effects of Singing on Vascular Health in Older Adults with Coronary Artery Disease: A Randomized Trial. medRxiv \[Preprint\]. 2024 Jul 27:2024.07.25.24311033. doi: 10.1101/2024.07.25.24311033. PMID: 39108506; PMCID: PMC11302710."|||0.570
72451846|NCT01084863|144425947|EQUIVALENCE|Pharmacokinetic equivalence was predefined based on acceptance criteria, 80% to 125%.|Geometric Mean Ratio|104.57|||||TWO_SIDED|90.0|93.64|116.78||||||||116.78|93.64|
72451847|NCT03473223|144425953|SUPERIORITY||Hazard Ratio (HR)|0.925||||0.121|TWO_SIDED|95.0|0.8126|1.0538||1-sided p-value.|Cox proportional hazards regression|||||1.0538|0.8126|0.121
72451848|NCT03473223|144425954|SUPERIORITY||Rate ratio|0.971||||0.341|TWO_SIDED|95.0|0.8442|1.1171||1-sided p-value|Negative binomial regression model|||||1.1171|0.8442|0.341
72451849|NCT03473223|144425955|SUPERIORITY||Hazard Ratio (HR)|0.907||||0.038|TWO_SIDED|95.0|0.8132|1.0106||1-sided p-value.|Cox proportional hazards regression|||||1.0106|0.8132|0.038
72451850|NCT03473223|144425956|SUPERIORITY||Hazard Ratio (HR)|0.933||||0.069|TWO_SIDED|95.0|0.8511|1.0224||1-sided p-value.|Cox proportional hazards regression|||||1.0224|0.8511|0.069
72451851|NCT03473223|144425957|SUPERIORITY||Hazard Ratio (HR)|0.827||||0.074|TWO_SIDED|95.0|0.6399|1.0695||1-sided p-value.|Cox proportional hazards regression|||||1.0695|0.6399|0.074
72451852|NCT03473223|144425958|SUPERIORITY||Hazard Ratio (HR)|0.909||||0.113|TWO_SIDED|95.0|0.7801|1.0603||1-sided p-value.|Cox proportional hazards regression|||||1.0603|0.7801|0.113
72451853|NCT03473223|144425959|SUPERIORITY||Hazard Ratio (HR)|1.153||||0.767|TWO_SIDED|95.0|0.7867|1.6886||1-sided p-value.|Cox proportional hazards regression|||||1.6886|0.7867|0.767
72451854|NCT03524092|144425978|SUPERIORITY||Risk Difference (RD)|23.2|||<|0.001|TWO_SIDED|95.0|15.2|31.2|||Cochran-Mantel-Haenszel|||||31.2|15.2|<0.001
72451855|NCT03524092|144425979|SUPERIORITY||Risk Difference (RD)|28.5|||<|0.001|TWO_SIDED|95.0|20.2|36.8|||Cochran-Mantel-Haenszel|||||36.8|20.2|<0.001
72451856|NCT03524092|144425980|SUPERIORITY||Risk Difference (RD)|22.5|||<|0.001|TWO_SIDED|95.0|14.5|30.5|||Cochran-Mantel-Haenszel|||||30.5|14.5|<0.001
72451857|NCT03524092|144425981|SUPERIORITY||Risk Difference (RD)|30.2|||<|0.001|TWO_SIDED|95.0|21.9|38.6|||Cochran-Mantel-Haenszel|||||38.6|21.9|<0.001
72451858|NCT03524092|144425982|SUPERIORITY||Risk Difference (RD)|31.0|||<|0.001|TWO_SIDED|95.0|22.4|39.6|||Cochran-Mantel-Haenszel|||||39.6|22.4|<0.001
72451859|NCT03524092|144425983|SUPERIORITY||Risk Difference (RD)|30.6|||<|0.001|TWO_SIDED|95.0|22.3|38.9|||Cochran-Mantel-Haenszel|||||38.9|22.3|<0.001
72451860|NCT03524092|144425984|SUPERIORITY||LS Mean difference (Final Values)|25.24|STANDARD_ERROR_OF_MEAN|3.094|<|0.001|TWO_SIDED|95.0|19.16|31.32|||ANCOVA|ANCOVA with modified baseline observation carried forward (mBOCF).||||31.32|19.16|<0.001
72451861|NCT03524092|144425985|SUPERIORITY||LS Mean difference (Final Values)|-839.64|STANDARD_ERROR_OF_MEAN|245.99|<|0.001|TWO_SIDED|95.0|-1323.08|-356.21|||ANCOVA|ANCOVA with modified baseline observation carried forward (mBOCF).||||-356.21|-1323.08|<0.001
72451862|NCT03524092|144425986|SUPERIORITY||LS Mean difference (Final Values)|-1.06|STANDARD_ERROR_OF_MEAN|0.228|<|0.001|TWO_SIDED|95.0|-1.51|-0.61|||Mixed Models Analysis|||||-0.61|-1.51|<0.001
72451863|NCT03275285|144426004|SUPERIORITY|For PFS, the nominal significance levels at primary analysis was determined using alpha-spending function in order to control overall 1-sided type 1 error at 2.5%. The 1-sided nominal significance level to declare overwhelming efficacy at primary analysis (103 PFS events) was 0.005. Because the median PFS was not reached at the primary analysis, it was described at the final analysis.|Hazard Ratio (HR)|0.531||||0.0007|TWO_SIDED|99.0|0.318|0.889||One-sided p-value based on Stratified log-rank test. Threshold for statistical significance at 0.005.|Stratified Log-Rank test|Stratified on number of prior lines of therapy (1 vs \>1) \& revised international staging system stage (I/II vs III vs not classified) as per IRT.|Hazard Ratio was stratified on number of prior lines of therapy (1 vs. \>1) and R-ISS stage (I or II vs. III vs. not classified) according to IRT.|Statistical analysis for comparison of PFS between the Kd and IKd arms based on primary analysis.||0.889|0.318|0.0007
72562032|NCT04381481|144655186|SUPERIORITY||||||<|0.01||||||The a priori threshold for statistical significance is \< 0.05.|Regression, Linear|||Beverages with claim compared to control beverage||||<0.01
72562033|NCT04381481|144655187|SUPERIORITY||||||<|0.001||||||The a priori threshold for statistical significance is \< 0.05.|Regression, Linear|||beverages with claim compared to control beverage||||<0.001
72562034|NCT04381481|144655188|SUPERIORITY||||||<|0.001||||||The a priori threshold for statistical significance is \< 0.05.|Regression, Linear|||beverages with claim compared to control beverage||||<0.001
72451864|NCT03275285|144426005|SUPERIORITY|The 1-sided nominal significance level to declare overwhelming efficacy at primary analysis was 0.004. Because the median PFS was not reached at the primary analysis, it was described at the final analysis.|Hazard Ratio (HR)|0.548||||0.0016|TWO_SIDED|99.2|0.317|0.948||One-sided p-value based on Stratified log-rank test. Threshold for statistical significance at 0.004.|Stratified Log-Rank test|Stratified on number of prior lines of therapy (1 vs \>1) \& revised international staging system stage (I/II vs III vs not classified) as per IRT.|Hazard Ratio was stratified on number of prior lines of therapy (1 vs. \>1) and R-ISS stage (I or II vs. III vs. not classified) according to IRT.|Statistical analysis for comparison of PFS between the Kd and IKd arm based on primary analysis.||0.948|0.317|0.0016
72562035|NCT04381481|144655189|SUPERIORITY||||||<|0.001||||||The a priori threshold for statistical significance is \< 0.05.|Regression, Linear|||beverages with claim compared to control beverage||||<0.001
72562036|NCT04381481|144655190|SUPERIORITY||||||<|0.001||||||The a priori threshold for statistical significance is \< 0.05.|Regression, Linear|||beverages with claim compared to control beverage||||<0.001
72562037|NCT04381481|144655191|SUPERIORITY||||||<|0.01||||||The a priori threshold for statistical significance is \< 0.05.|Regression, Logistic|||beverages with claim compared to control beverage||||<0.01
72562038|NCT04381481|144655192|SUPERIORITY||||||<|0.01||||||The a priori threshold for statistical significance is \< 0.05.|Regression, Linear|||beverages with claim compared to control beverage||||<0.01
72562039|NCT04381481|144655193|SUPERIORITY||||||<|0.001||||||The a priori threshold for statistical significance is \< 0.05.|Regression, Linear|||beverages with claim compared to control beverage||||<0.001
72619878|NCT01539525|144770911|SUPERIORITY_OR_OTHER||Slope|-0.078|STANDARD_ERROR_OF_MEAN|0.034||0.038|TWO_SIDED|95.0|-0.151|-0.004||P-value adjusted for multiple comparisons using Holm's step-down multiple testing procedure. The a priori threshold for statistical significance was p \< 0.05.|Generalized Estimating Equation|adjusted for stratifying variables- primary substance and pregnancy status|Estimated parameter is treatment x linear time interaction term coefficient- Motivational Interview- Nurse vs. Treatment as Usual|Differences in days/month of primary substance use over time between treatment groups were examined using generalized estimating equations (GEE). We specified a negative binomial distribution to account for overdispersion in days/month of primary substance use, a log link function, and a first-order autoregressive working correlation structure. β coefficients were estimated using quasi-likelihood estimation methods and sandwich/empirical standard errors were calculated.||-0.004|-0.151|0.038
72622438|NCT02181413|144774852|SUPERIORITY||Hazard Ratio (HR)|1.015||||0.902|TWO_SIDED|95.0|0.795|1.298||P-value was based on log-rank test stratified by pre-induction regimen, ISS stage and response after transplantation.|Log Rank||Hazard ratio is based on an unadjusted Cox's proportional hazard regression model stratified by induction regimen, pre-induction ISS, and response after transplantation, comparing the hazard rate of Ixazomib arm over the hazard rate of Placebo arm.|||1.298|0.795|0.902
72451865|NCT03275285|144426006|SUPERIORITY||Hazard Ratio (HR)|0.576|||||TWO_SIDED|95.4|0.418|0.792|||||Hazard Ratio was stratified on number of prior lines of therapy (1 vs. \>1) and R-ISS stage (I or II vs. III vs. not classified) according to IRT.|||0.792|0.418|
72451866|NCT03275285|144426007|SUPERIORITY||Hazard Ratio (HR)|0.594|||||TWO_SIDED|95.4|0.424|0.832|||||Hazard Ratio was stratified on number of prior lines of therapy (1 vs. \>1) and R-ISS stage (I or II vs. III vs. not classified) according to IRT.|||0.832|0.424|
72562040|NCT04381481|144655194|SUPERIORITY||||||<|0.001||||||The a priori threshold for statistical significance is \< 0.05.|Regression, Linear|||beverages with claim compared to control beverage||||<0.001
72562041|NCT04381481|144655195|SUPERIORITY||||||<|0.001||||||The a priori threshold for statistical significance is \< 0.05.|Regression, Linear|||beverages with claim compared to control beverage||||<0.001
72562042|NCT04381481|144655196|SUPERIORITY||||||<|0.001||||||The a priori threshold for statistical significance is \< 0.05.|Regression, Linear|||warning snacks compared to control snack||||<0.001
72562043|NCT04381481|144655197|SUPERIORITY||||||<|0.001||||||The a priori threshold for statistical significance is \< 0.05.|Regression, Linear|||warning snacks compared to control snack||||<0.001
72562044|NCT04381481|144655198|SUPERIORITY||||||<|0.001||||||The a priori threshold for statistical significance is \< 0.05.|Regression, Linear|||warning snacks compared to control snack||||<0.001
72562045|NCT04381481|144655199|SUPERIORITY||||||<|0.001||||||The a priori threshold for statistical significance is \< 0.05.|Regression, Linear|||warning snacks compared to control snack||||<0.001
72562046|NCT04381481|144655200|SUPERIORITY||||||<|0.001||||||The a priori threshold for statistical significance is \< 0.05.|Regression, Linear|||warning snacks compared to control snack||||<0.001
72562047|NCT04381481|144655201|SUPERIORITY||||||<|0.001||||||The a priori threshold for statistical significance is \< 0.05.|Regression, Linear|||warning snacks compared to control snack||||<0.001
72562048|NCT04381481|144655202|SUPERIORITY||||||<|0.001||||||The a priori threshold for statistical significance is \< 0.05.|Regression, Linear|||warning snacks compared to control snack||||<0.001
72562049|NCT04381481|144655203|SUPERIORITY||||||<|0.001||||||The a priori threshold for statistical significance is \< 0.05.|Regression, Linear|||warning snacks compared to control snack||||<0.001
72562050|NCT04381481|144655204|SUPERIORITY||||||<|0.001||||||The a priori threshold for statistical significance is \< 0.05.|Regression, Linear|||warning snacks compared to control snack||||<0.001
72562051|NCT04381481|144655205|SUPERIORITY||||||<|0.001||||||The a priori threshold for statistical significance is \< 0.05.|Regression, Linear|||warning snacks compared to control snack||||<0.001
72562052|NCT04381481|144655206|SUPERIORITY||||||<|0.001||||||The a priori threshold for statistical significance is \< 0.05.|Regression, Linear|||warning snacks compared to control snack||||<0.001
72619879|NCT01539525|144770911|SUPERIORITY_OR_OTHER||Slope|-0.09|STANDARD_ERROR_OF_MEAN|0.034||0.008|TWO_SIDED|95.0|-0.157|-0.023||P-value adjusted for multiple comparisons using Holm's step-down multiple testing procedure. The a priori threshold for statistical significance was p \< 0.025|Generalized Estimating Equation|adjusted for stratifying variables- primary substance and pregnancy status|Estimated parameter is treatment x linear time interaction term coefficient- Motivational Interview- Computer vs. Treatment as Usual|Differences in days/month of primary substance use over time between treatment groups were examined using generalized estimating equations (GEE). We specified a negative binomial distribution to account for overdispersion in days/month of primary substance use, a log link function, and a first-order autoregressive working correlation structure. β coefficients were estimated using quasi-likelihood estimation methods and sandwich/empirical standard errors were calculated.||-0.023|-0.157|0.008
72619880|NCT01539525|144770911|SUPERIORITY_OR_OTHER||Slope|0.011|STANDARD_ERROR_OF_MEAN|0.005||0.031|TWO_SIDED|95.0|0.001|0.022||P-value adjusted for multiple comparisons using Holm's step-down multiple testing procedure. The a priori threshold for statistical significance was p \< 0.05.|Generalized Estimating Equation|adjusted for stratifying variables- primary substance and pregnancy status|Estimated parameter is treatment x quadratic time interaction term coefficient- Motivational Interview- Nurse vs. Treatment as Usual|Differences in days/month of primary substance use over time between treatment groups were examined using generalized estimating equations (GEE). We specified a negative binomial distribution to account for overdispersion in days/month of primary substance use, a log link function, and a first-order autoregressive working correlation structure. β coefficients were estimated using quasi-likelihood estimation methods and sandwich/empirical standard errors were calculated.||0.022|0.001|0.031
72622439|NCT02181413|144774853|SUPERIORITY||Hazard Ratio (HR)|0.833||||0.056|TWO_SIDED|95.0|0.69|1.005|||Log Rank|P-value was based on log-rank test stratified by pre-induction regimen, ISS stage and response after transplantation.|Hazard ratio is based on an unadjusted Cox's proportional hazard regression model stratified by induction regimen, pre-induction ISS, and response after transplantation, comparing the hazard rate of Ixazomib arm over the hazard rate of Placebo arm.|||1.005|0.690|0.056
72451867|NCT03275285|144426008|SUPERIORITY|A closed test procedure was used to control the Type I error rate from the primary efficacy endpoints sequentially through the secondary efficacy endpoints. No further testing would be performed unless the significance level had been reached on PFS and testing on subsequent endpoints were continued only if the null hypothesis for the previously tested endpoint was rejected.||||||0.193||||||One-sided p-value based on Stratified Cochran-Mantel-Haenszel test. Threshold for statistical significance level at 0.025.|Cochran-Mantel-Haenszel|One sided p-value was stratified based on randomization factors according to IRT.||Statistical analysis for comparison of Overall Response between the Kd and IKd arms based on primary analysis.||||0.1930
72451868|NCT03275285|144426015|SUPERIORITY||Stratified Hazard Ratio|0.425|||||TWO_SIDED|95.0|0.269|0.672|||||Stratification was done on the number of prior lines of therapy (1 vs. \>1) and R-ISS stage (I or II vs. III vs. not classified) according to IRT.|||0.672|0.269|
72562053|NCT04381481|144655207|SUPERIORITY||||||<|0.001||||||The a priori threshold for statistical significance is \< 0.05.|Regression, Linear|||warning snacks compared to control snack||||<0.001
72562054|NCT04381481|144655208|SUPERIORITY||||||<|0.001||||||The a priori threshold for statistical significance is \< 0.05.|Regression, Linear|||warning snacks compared to control snack||||<0.001
72562055|NCT04381481|144655209|SUPERIORITY||||||<|0.001||||||The a priori threshold for statistical significance is \< 0.05.|Regression, Linear|||warning snacks compared to control snack||||<0.001
72562056|NCT03460990|144655312|SUPERIORITY||Least Squares (LS) Mean Difference|10.0|||<|0.0001|TWO_SIDED|95.0|7.4|12.5|||Mixed-effects model for repeated measure|||||12.5|7.4|< 0.0001
72562057|NCT03460990|144655313|SUPERIORITY||LS Mean Difference|-48.7|||<|0.0001|TWO_SIDED|95.0|-53.9|-43.5|||Mixed-effects model for repeated measure|||||-43.5|-53.9|<0.0001
72562058|NCT03460990|144655314|SUPERIORITY||LS Mean Difference|13.5|||<|0.0001|TWO_SIDED|95.0|8.8|18.3|||Mixed-effects model for repeated measure|||||18.3|8.8|<0.0001
72562059|NCT01435824|144655321|EQUIVALENCE|Bioequivalence is assessed by means of ratios of AUC, Cmax and Tmax between the comparison group and the reference group. According to a common regulatory definition, the comparison preparation (human milk-dissolved amoxicillin in this project) is considered bioequivalent to a standard preparation (water dissolved) if 90% CIs of these ratios between the two preparations for Cmax, Tmax, AUClast and AUC∞ are within a range between 0.80 and 1.25.|mean %ratio and 90% confidence interval|106.1|||||TWO_SIDED|90.0|97.5|115.4||||||A 2x2 crossover design was chosen to examine bioequivalence of milk-based amoxicillin preparation, based on the FDA-recommended design for bioavailability studies. The recommendation suggests that 12 subjects is the minimum number of subjects acceptable for this type of design. We have decided to enrol 16 subjects to account for problems or attrition.||115.4|97.5|
72562060|NCT01435824|144655322|EQUIVALENCE|Bioequivalence is assessed by means of ratios of AUC, Cmax and Tmax between the comparison group and the reference group. According to a common regulatory definition, the comparison preparation (human milk-dissolved amoxicillin in this project) is considered bioequivalent to a standard preparation (water dissolved) if 90% CIs of these ratios between the two preparations for Cmax, Tmax, AUClast and AUC∞ are within a range between 0.80 and 1.25.|mean %ratio and 90% confidence interval|106.2|||||TWO_SIDED|90.0|97.5|115.7||||||A 2x2 crossover design was chosen to examine bioequivalence of milk-based amoxicillin preparation, based on the FDA-recommended design for bioavailability studies. The recommendation suggests that 12 subjects is the minimum number of subjects acceptable for this type of design. We have decided to enrol 16 subjects to account for problems or attrition.||115.7|97.5|
72562061|NCT01435824|144655323|EQUIVALENCE|Bioequivalence is assessed by means of ratios of AUC, Cmax and Tmax between the comparison group and the reference group. According to a common regulatory definition, the comparison preparation (human milk-dissolved amoxicillin in this project) is considered bioequivalent to a standard preparation (water dissolved) if 90% CIs of these ratios between the two preparations for Cmax, Tmax, AUClast and AUC∞ are within a range between 0.80 and 1.25.|mean %ratio and 90% confidence interval|101.3|||||TWO_SIDED|90.0|89.4|114.9||||||A 2x2 crossover design was chosen to examine bioequivalence of milk-based amoxicillin preparation, based on the FDA-recommended design for bioavailability studies. The recommendation suggests that 12 subjects is the minimum number of subjects acceptable for this type of design. We have decided to enrol 16 subjects to account for problems or attrition.||114.9|89.4|
72451869|NCT03275285|144426016|SUPERIORITY||Stratified Hazard Ratio|0.495|||||TWO_SIDED|95.0|0.324|0.757|||||Stratification was done on the number of prior lines of therapy (1 vs. \>1) and R-ISS stage (I or II vs. III vs. not classified) according to IRT.|||0.757|0.324|
72451870|NCT03275285|144426017|SUPERIORITY||Stratified Hazard Ratio|1.143|||||TWO_SIDED|95.0|0.888|1.471|||||||Stratification was done on the number of prior lines of therapy (1 vs. \>1) and R-ISS stage (I or II vs. III vs. not classified) according to IRT.|1.471|0.888|
72451871|NCT03275285|144426018|SUPERIORITY||Stratified Hazard Ratio|0.955|||||TWO_SIDED|95.0|0.74|1.233|||||Stratification was done on the number of prior lines of therapy (1 vs. \>1) and R-ISS stage (I or II vs. III vs. not classified) according to IRT.|||1.233|0.740|
72451872|NCT03275285|144426019|SUPERIORITY|\[Not specified\]|[Stratified Hazard Ratio]|0.683|||||TWO_SIDED|95.0|0.496|0.941|||||Stratification was done on the number of prior lines of therapy (1 vs. \>1) and R-ISS stage (I or II vs. III vs. not classified) according to IRT.|\[Not specified\]||0.941|0.496|
72451873|NCT03275285|144426020|SUPERIORITY|\[Not specified\]|Stratified Hazard Ratio|0.663|||||TWO_SIDED|95.0|0.491|0.895|||||Stratification was done on the number of prior lines of therapy (1 vs. \>1) and R-ISS stage (I or II vs. III vs. not classified) according to IRT.|\[Not specified\]||0.895|0.491|
72451874|NCT00115934|144426043|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|-10.1||||0.013||95.0|-17.8|-2.4|||Fisher Exact||The risk difference is defined as the percent of subjects with events in the RVPAS group minus the percent of subjects with events in the MBTS group.|The original sample size of 456 was based on 85% power, with a two-sided, two sample test of proportions (anticipating 28% MBTS subjects with events, 16% RVPAS subjects with events), and an alpha of 0.05. The critical p-value was 0.044 because four interim analyses were performed. The target trial size was increased from 466 to 554 to account for crossovers. The stopping boundary was crossed at the 4th interim look; however, the trial was not halted, because all subjects were enrolled.||-2.4|-17.8|0.013
72451875|NCT00115934|144426044|SUPERIORITY_OR_OTHER_LEGACY|||||||0.06||95.0|||||Log Rank|||||||0.06
72622440|NCT02181413|144774854|SUPERIORITY||Hazard Ratio (HR)|0.922||||0.431|TWO_SIDED|95.0|0.753|1.129||P-value was based on log-rank test stratified by pre-induction regimen, ISS stage, and response after transplantation.|Log Rank||Hazard ratio is based on an unadjusted Cox's proportional hazard regression model stratified by induction regimen, pre-induction ISS, and response after transplantation, comparing the hazard rate of Ixazomib arm over the hazard rate of Placebo arm.|||1.129|0.753|0.431
72451876|NCT00115934|144426045|SUPERIORITY_OR_OTHER_LEGACY|||||||0.09|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||0.09
72451877|NCT00115934|144426046|SUPERIORITY_OR_OTHER_LEGACY|||||||0.009||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.009
72451878|NCT00115934|144426047|SUPERIORITY_OR_OTHER_LEGACY|||||||0.07||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.07
72451879|NCT00115934|144426048|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.001
72451880|NCT00115934|144426049|SUPERIORITY_OR_OTHER_LEGACY|||||||0.004||95.0|||||Wilcoxon (Mann-Whitney)|||Wilcoxon rank-sum test||||0.004
72451881|NCT00115934|144426050|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.10
72451882|NCT00115934|144426051|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||t-test, 2 sided|||||||<0.001
72451883|NCT00115934|144426052|SUPERIORITY_OR_OTHER_LEGACY|||||||0.07||95.0|||||t-test, 2 sided|||||||0.07
72451884|NCT00115934|144426053|SUPERIORITY_OR_OTHER_LEGACY|||||||0.97||95.0|||||t-test, 2 sided|||||||0.97
72451885|NCT00115934|144426054|SUPERIORITY_OR_OTHER_LEGACY|||||||0.54||95.0|||||t-test, 2 sided|||||||0.54
72451886|NCT00115934|144426055|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||t-test, 2 sided|||||||<0.001
72451887|NCT00115934|144426056|SUPERIORITY_OR_OTHER_LEGACY|||||||0.003||95.0|||||Poisson regression|The offset parameter used in the poisson regression was the log of the number of patients in each treatment arm.||||||0.003
72451888|NCT00115934|144426057|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2||95.0|||||Poisson Regression|The offset parameter used in this analysis was the log of the number of patients per treatment arm.||||||0.20
72451889|NCT00115934|144426058|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002||95.0|||||Poisson Regression|The offset parameter used in this analysis was the log of the number of patients per treatment arm.||||||0.002
72451890|NCT00115934|144426059|SUPERIORITY_OR_OTHER_LEGACY|||||||0.03||95.0|||||Poisson regression|The offset parameter used in this analysis was the log of the number of patients per treatment arm.||||||0.03
72451891|NCT00353496|144426089|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.47|||<|0.001|TWO_SIDED|95.0|0.3|0.73||No p-value adjustment for multiple comparisons.|Log Rank|The log rank test was stratified according to progression status at baseline and prior therapy.||||0.73|0.30|<0.001
72451892|NCT01288443|144426103|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Threshold for significance ≤ 0.05.|ANCOVA|||"Each treatment group was compared to placebo using ANCOVA-derived contrasts.~A hierarchical testing procedure was applied to ensure strong control of overall Type-I error rate at 0.05 level. Order was following:~1. Alirocumab 150 mg Q2W versus placebo~2. Alirocumab 300 mg Q4W versus placebo~3. Alirocumab 100 mg Q2W versus placebo~4. Alirocumab 200 mg Q4W versus placebo~5. Alirocumab 50 mg Q2W versus placebo~Testing continued only when high-order test was statistically significant at 5% level"||||<0.0001
72451893|NCT01288443|144426103|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Threshold for significance ≤ 0.05.|ANCOVA|||||||<0.0001
72451894|NCT01288443|144426103|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Threshold for significance ≤ 0.05.|ANCOVA|||||||<0.0001
72451895|NCT01288443|144426103|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Threshold for significance ≤ 0.05.|ANCOVA|||||||<0.0001
72451896|NCT01288443|144426103|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Threshold for significance ≤ 0.05.|ANCOVA|||||||<0.0001
72451897|NCT04327843|144426115|OTHER|This is a prospective study with a repeated measures design.||||||0.001||||||The threshold for statistical significance was p\<0.05.|t-test, 2 sided|It was dependent sample pairwise t-tests, two tailed||||||0.001
72451898|NCT04327843|144426116|OTHER|This is a prospective study with a repeated measures design.||||||0.43||||||The threshold for statistical significance was p\<0.05.|t-test, 2 sided|It was dependent sample pairwise t-tests, two tailed.||||||0.43
72451899|NCT04327843|144426117|OTHER|This is a prospective study with a repeated measures design.||||||0.07||||||The threshold for statistical significance was p\<0.05.|t-test, 2 sided|It was dependent sample pairwise t-tests, two tailed.||||||0.07
72451900|NCT04327843|144426118|OTHER|This is a prospective study with a repeated measures design.||||||0.1||||||The threshold for statistical significance was p\<0.05.|t-test, 2 sided|It was dependent sample pairwise t-tests, two tailed.||||||0.10
72451901|NCT04327843|144426119|OTHER|This is a prospective study with a repeated measures design.||||||0.75||||||The threshold for statistical significance was p\<0.05.|t-test, 2 sided|It was dependent sample pairwise t-tests, two tailed.||||||0.75
72451902|NCT04327843|144426120|OTHER|This is a prospective study with a repeated measures design.||||||1||||||The threshold for statistical significance was p\<0.05.|t-test, 2 sided|It was dependent sample pairwise t-tests, two tailed.||||||1.00
72451903|NCT04327843|144426122|OTHER|This is a prospective study with a repeated measures design.||||||0.75||||||The threshold for statistical significance was p\<0.05.|t-test, 2 sided|It was dependent sample pairwise t-tests, two tailed.||||||0.75
72451904|NCT04327843|144426123|OTHER|This is a prospective study with a repeated measures design.||||||0.14||||||The threshold for statistical significance was p\<0.05.|t-test, 2 sided|It was dependent sample pairwise t-tests, two tailed.||||||0.14
72451905|NCT05274321|144426124|NON_INFERIORITY|The noninferiority margin was determined by taking 10% of the standard of care change score. Noninferiority was determined for each outcome if the noninferiority margin did not overlap with the regression coefficient's 95% confidence interval.||||||0.22||||||Wald P values were calculated by testing whether the regression coefficient met or exceeded the noninferiority margin.|Regression, Linear|The threshold for significance is 0.0167.||Absolute between-eye differences were calculated for each participant by subtracting the standard of care (SOC) change score from the Nanodropper change score. The confidence interval (CI) is 95%.||||0.22
72451906|NCT05274321|144426125|NON_INFERIORITY|The noninferiority margin was determined by taking 10% of the standard of care change score. Noninferiority was determined for each outcome if the noninferiority margin did not overlap with the regression coefficient's 95% confidence interval. .||||||0.02||||||Wald P values were calculated by testing whether the regression coefficient met or exceeded the noninferiority margin.|Regression, Linear|The threshold for significance is 0.0167.||Absolute between-eye differences were calculated for each participant by subtracting the standard of care (SOC) change score from the Nanodropper change score. The confidence interval (CI) is 95%.||||0.02
72451907|NCT05274321|144426126|NON_INFERIORITY|The noninferiority margin was determined by taking 10% of the standard of care change score. Noninferiority was determined for each outcome if the noninferiority margin did not overlap with the regression coefficient's 95% confidence interval.||||||0.03||||||Wald P values were calculated by testing whether the regression coefficient met or exceeded the noninferiority margin.|Regression, Linear|The threshold for significance is 0.0167.||Absolute between-eye differences were calculated for each participant by subtracting the standard of care (SOC) change score from the Nanodropper change score. The confidence interval (CI) is 95%.||||0.03
72451908|NCT05274321|144426127|NON_INFERIORITY|The noninferiority margin was determined by taking 10% of the standard of care change score. Noninferiority was determined for each outcome if the noninferiority margin did not overlap with the regression coefficient's 95% confidence interval.||||||0.25||||||Wald P values were calculated by testing whether the regression coefficient met or exceeded the noninferiority margin.|Regression, Linear|The threshold for significance is 0.0167.||Absolute between-eye differences were calculated for each participant by subtracting the standard of care (SOC) change score from the Nanodropper change score. The confidence interval (CI) is 95%.||||0.25
72451909|NCT01105975|144426128|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|78.5|||<|0.001|TWO_SIDED|90.0|64.9|92.1|||mixed model repeated measures (MMRM)|||||92.1|64.9|<0.001
72451910|NCT01105975|144426129|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.9||||0.002|TWO_SIDED|90.0|-21.2|-6.7|||mixed model repeated measures (MMRM)|||||-6.7|-21.2|0.002
72451911|NCT01105975|144426130|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|56.7|||<|0.001|TWO_SIDED|90.0|43.6|69.8|||mixed model repeated measures (MMRM)|||||69.8|43.6|<0.001
72451912|NCT01105975|144426130|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|97.6|||<|0.001||90.0|84.5|110.8|||mixed model repeated measures (MMRM)|||||110.8|84.5|<0.001
72451913|NCT01105975|144426130|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|131.9|||<|0.001|TWO_SIDED|90.0|118.5|145.2|||mixed model repeated measures (MMRM)|||||145.2|118.5|<0.001
72451914|NCT01105975|144426131|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.6|||<|0.001|TWO_SIDED|90.0|-24.6|-10.5|||mixed model repeated measures (MMRM)|||||-10.5|-24.6|<0.001
72451915|NCT01105975|144426131|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-26.2|||<|0.001|TWO_SIDED|90.0|-33.2|-19.2|||mixed model repeated measures (MMRM)|||||-19.2|-33.2|<0.001
72451916|NCT01105975|144426131|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-39.8|||<|0.001|TWO_SIDED|90.0|-47.0|-32.7|||mixed model repeated measures (MMRM)|||||-32.7|-47.0|<0.001
72451917|NCT01105975|144426132|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|79.3|||<|0.001||90.0|66.2|92.4|||mixed model repeated measures (MMRM)|||||92.4|66.2|<0.001
72451918|NCT01105975|144426132|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|88.5|||<|0.001|TWO_SIDED|90.0|75.2|101.8|||mixed model repeated measures (MMRM)|||||101.8|75.2|<0.001
72451919|NCT01105975|144426133|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.2||||0.009|TWO_SIDED|90.0|-18.3|-4.2|||mixed model repeated measures (MMRM)|||||-4.2|-18.3|0.009
72451920|NCT01105975|144426133|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.5||||0.002|TWO_SIDED|90.0|-20.6|-6.4|||mixed model repeated measures (MMRM)|||||-6.4|-20.6|0.002
72451921|NCT03885232|144426157|SUPERIORITY|We applied a mixed zero-inflated beta regression model that included a fixed binary factor for treatment arm, a random effect for clinic to account for correlation within clinics, and unbalanced parent demographics across study arms.|Incidence Rate Ratio (IRR)|1.04||||0.9|TWO_SIDED|95.0|0.68|1.6|||Generalized linear mixed effects regress|Generalized linear mixed effects regression models||||1.60|0.68|0.9
72451922|NCT03885232|144426158|SUPERIORITY||Other|1.0|||<|0.05|TWO_SIDED||||||Chi-squared|||Calculated individual survey means for vaccine hesitant parents who participated in the survey. Survey consisted of 15 questions with a 7-point Likert scale. We then created a dichotomous variable where 1 = mean \> or equal to 6; 0 = mean \< 6.||||<0.05
72451923|NCT03885232|144426159|SUPERIORITY||Odds Ratio (OR)|1.92|||<|0.05|TWO_SIDED|95.0|0.66|5.64|||Generalized linear mixed effects regress|Adjusted for: study arm, study period (pre vs. post), years in practice, provider type, interaction between study arm and study period||"1. Ho: No difference in the proportion of clinicians using presumptive and Motivational Interviewing techniques between intervention and control.~2. Ho: No difference in the proportion of clinicians time spent talking to vaccine hesitant parents between intervention and control."||5.64|0.66|<0.05
72451924|NCT03260569|144426162|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
72451925|NCT02879318|144426194|SUPERIORITY||Hazard Ratio (HR)|0.94||||0.72|TWO_SIDED|90.0|0.71|1.25||a priori threshold for statistical significance was 0.1.|Log Rank|stratified by ECOG performance status and prior adjuvant therapy.||||1.25|0.71|0.72
72451926|NCT02879318|144426195|SUPERIORITY||Hazard Ratio (HR)|0.98||||0.91|TWO_SIDED|90.0|0.75|1.29|||Log Rank|||||1.29|0.75|0.91
72451927|NCT02879318|144426196|SUPERIORITY||Odds Ratio (OR)|1.49||||0.28|TWO_SIDED|90.0|0.81|2.72|||Cochran-Mantel-Haenszel|stratified by ECOG performance status and prior adjuvant chemotherapy||||2.72|0.81|0.28
72562062|NCT01435824|144655324|EQUIVALENCE|Bioequivalence is assessed by means of ratios of AUC, Cmax and Tmax between the comparison group and the reference group. According to a common regulatory definition, the comparison preparation (human milk-dissolved amoxicillin in this project) is considered bioequivalent to a standard preparation (water dissolved) if 90% CIs of these ratios between the two preparations for Cmax, Tmax, AUClast and AUC∞ are within a range between 0.80 and 1.25.|mean %ratio and 90% confidence interval|107.9|||||TWO_SIDED|90.0|84.5|137.8||||||A 2x2 crossover design was chosen to examine bioequivalence of milk-based amoxicillin preparation, based on the FDA-recommended design for bioavailability studies. The recommendation suggests that 12 subjects is the minimum number of subjects acceptable for this type of design. We have decided to enrol 16 subjects to account for problems or attrition.||137.8|84.5|
72562063|NCT00117806|144655332|SUPERIORITY_OR_OTHER|||||||0.008|TWO_SIDED||||||Chi-squared|||||||0.008
72451928|NCT03280030|144426198|OTHER|Success criteria is considered based on point estimated Hazard ratio|Hazard Ratio, log|1.326|||||TWO_SIDED|95.0|0.624|2.818||||||||2.818|0.624|
72451929|NCT03867201|144426244|SUPERIORITY||Mean Difference (Net)|-1.57|STANDARD_ERROR_OF_MEAN|0.64||0.015|TWO_SIDED|95.0|-2.83|-0.3|||Mixed Models Analysis|||||-0.30|-2.83|0.015
72451930|NCT01983683|144426250|NON_INFERIORITY|Non-inferiority of CCR for cadazolid versus vancomycin is demonstrated if the lower limit of the 95% confidence interval (CI) is above -10%|Difference between 2 proportions|-4.7|||||TWO_SIDED|95.0|-10.7|1.3|||||CI for the difference between two proportions are estimated using the Wilson's score method|||1.3|-10.7|
72451931|NCT01983683|144426250|NON_INFERIORITY|Non-inferiority of CCR for cadazolid versus vancomycin is demonstrated if the lower limit of the 95% confidence interval (CI) is above -10%|Difference between 2 proportions|-3.6|||||TWO_SIDED|95.0|-9.6|2.3|||||CI for the difference between two proportions are estimated using the Wilson's score method|Sensitivity analysis with imputation for a single day with missing UBM data between one day before end-of-treatment (EOT) and 2 days after EOT||2.3|-9.6|
72451932|NCT01983683|144426251|NON_INFERIORITY|Non-inferiority of CCR for cadazolid versus vancomycin is demonstrated if the lower limit of the 95% confidence interval (CI) is above -10%|Difference between 2 proportions|-4.9|||||TWO_SIDED|95.0|-10.4|0.6|||||CI for the difference between two proportions are estimated using the Wilson' score method|||0.6|-10.4|
72451933|NCT01983683|144426252|SUPERIORITY|Superiority of cadazolid versus vancomycin is demonstrated if the lower limit of the 95% confidence interval (CI) is above zero|Difference between 2 proportions|1.7|||||TWO_SIDED|95.0|-6.1|9.4|||||CI for the difference between two proportions are estimated using the Wilson's score method|||9.4|-6.1|
72451934|NCT01983683|144426253|SUPERIORITY||Hazard Ratio (HR)|1.04||||0.7794|TWO_SIDED|95.0|0.86|1.24||two-sided p-value (alpha 5%) based on log-rank test stratified by first occurrence / first recurrence and geographical region.|Log Rank|||||1.24|0.86|0.7794
72451935|NCT01983683|144426254|SUPERIORITY||Least Square Mean difference|-0.044||||0.6871|TWO_SIDED|95.0|-0.26|0.17||Two-sided 5% alpha level was used|ANOVA|ANOVA model for repeated measurements was fitted using all values from Day 1 (baseline) to Day 12.|The Least Square Means of the treatments differences for the changes from baseline at Day 3 were obtained using estimate statements|Comparison of the diarrhea domain scores||0.17|-0.26|0.6871
72451936|NCT01983683|144426254|SUPERIORITY||Least Square Mean difference|0.025||||0.7833|TWO_SIDED|95.0|-0.15|0.2||Two-sided 5% alpha level was used|ANOVA|ANOVA model for repeated measurements was fitted using all values from Day 1 (baseline) to Day 12.|The Least Square Means of the treatments differences for the changes from baseline at Day 3 were obtained using estimate statements|Comparison of the abdominal symptoms domain scores||0.20|-0.15|0.7833
72451937|NCT01983683|144426254|SUPERIORITY||Least Square Mean difference|0.061||||0.4145|TWO_SIDED|95.0|-0.09|0.21||Two-sided 5% alpha level was used|ANOVA|ANOVA model for repeated measurements was fitted using all values from Day 1 (baseline) to Day 12.|The Least Square Means of the treatments differences for the changes from baseline at Day 3 were obtained using estimate statements|Comparison of the other symptoms domain scores||0.21|-0.09|0.4145
72562064|NCT01765751|144655335|SUPERIORITY||Mean Difference (Final Values)|2.7|||||TWO_SIDED|95.0|-0.1|5.6|||||High vs Low group, mean difference adjusted for the baseline value of the respective variable centered at its mean. NDI also adjusted for traction-force feedback method.|||5.6|-0.1|
72451938|NCT01983683|144426255|OTHER||Difference between 2 proportions|-1.1|||||TWO_SIDED|95.0|-6.5|4.2|||||CI for the difference between two proportions are estimated using the Wilson's score method|Exploratory analysis||4.2|-6.5|
72562065|NCT01765751|144655335|SUPERIORITY||Mean Difference (Final Values)|3.0|||||TWO_SIDED|95.0|0.1|5.9|||||Medium vs Low group, mean difference adjusted for the baseline value of the respective variable centered at its mean. NDI also adjusted for traction-force feedback method.|||5.9|0.1|
72391442|NCT01619423|144289963|SUPERIORITY||Odds Ratio (OR)|0.62||||0.16|ONE_SIDED|10.0||1.14|||Cochran-Mantel-Haenszel|||||1.14||0.16
72562066|NCT01765751|144655335|SUPERIORITY||Mean Difference (Final Values)|-0.2|||||TWO_SIDED|95.0|-3.2|2.7|||||High vs Medium group, mean difference adjusted for the baseline value of the respective variable centered at its mean. NDI also adjusted for traction-force feedback method.|||2.7|-3.2|
72391443|NCT02340975|144289972|OTHER|Comparison|Mean Difference (Net)|11.1||||0.2376|TWO_SIDED|95.0|-0.7|23.0|||Fisher Exact|||||23.0|-0.7|0.2376
72391444|NCT02340975|144289972|OTHER|Comparison|Median Difference (Net)|2.8||||1|TWO_SIDED|95.0|-16.8|22.4|||Fisher Exact|||||22.4|-16.8|1.0000
72391445|NCT03066804|144290019|SUPERIORITY||Geometric Mean Ratio|0.8362|||<|0.0001|TWO_SIDED|95.0|0.7987|0.8754|||Mixed Models Analysis|||Week 12||0.8754|0.7987|<0.0001
72391446|NCT03066804|144290020|SUPERIORITY||Mean Difference (Net)|-2.4985||||0.4164|TWO_SIDED|95.0|-8.5267|3.52297|||Mixed Models Analysis|||||3.52297|-8.5267|0.4164
72562067|NCT01765751|144655336|SUPERIORITY||Mean Difference (Final Values)|15.6|||||TWO_SIDED|95.0|1.6|29.7|||||High vs Low group, mean difference adjusted for the baseline value of the respective variable centered at its mean. NDI also adjusted for traction-force feedback method.|||29.7|1.6|
72562068|NCT01765751|144655336|SUPERIORITY||Mean Difference (Final Values)|9.8|||||TWO_SIDED|95.0|-3.7|23.3|||||Medium vs Low group, mean difference adjusted for the baseline value of the respective variable centered at its mean. NDI also adjusted for traction-force feedback method.|||23.3|-3.7|
72562069|NCT01765751|144655336|SUPERIORITY||Mean Difference (Final Values)|5.8|||||TWO_SIDED|95.0|-8.6|20.3|||||High vs Medium group, mean difference adjusted for the baseline value of the respective variable centered at its mean. NDI also adjusted for traction-force feedback method.|||20.3|-8.6|
72562070|NCT01765751|144655337|SUPERIORITY||Mean Difference (Net)|-3.9|||||TWO_SIDED|95.0|-8.1|0.4|||||Pain Interference - High vs. Low Group - The scale for the PROMIS measures uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population.|Pain Interference||0.4|-8.1|
72562071|NCT01765751|144655337|SUPERIORITY||Mean Difference (Net)|1.5|||||TWO_SIDED|95.0|-2.6|5.6|||||Pain Interference - Medium vs Low Group - The scale for the PROMIS measures uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population.|Pain Interference||5.6|-2.6|
72391447|NCT03066804|144290021|SUPERIORITY||Mean Difference (Net)|0.5231||||0.4791|TWO_SIDED|95.0|-0.9258|1.972|||Mixed Models Analysis|||||1.9720|-0.9258|0.4791
72391448|NCT03066804|144290022|SUPERIORITY||Odds Ratio (OR)|0.8993||||0.5294|TWO_SIDED|95.0|0.6461|1.2518|||longitudinal binary logistic regression|||||1.2518|0.6461|0.5294
72391449|NCT03066804|144290023|SUPERIORITY||Odds Ratio (OR)|1.106||||0.4938|TWO_SIDED|95.0|0.8287|1.476|||longitudinal binary logistic regression|||||1.4760|0.8287|0.4938
72391450|NCT03066804|144290024|SUPERIORITY||Odds Ratio (OR)|0.9798||||0.8314|TWO_SIDED|95.0|0.8122|1.182|||Proportional cumulative odds model|||||1.1820|0.8122|0.8314
72391451|NCT03066804|144290025|SUPERIORITY||Mean Difference (Net)|-0.157||||0.637||95.0|-0.8093|0.4953|||Mixed Models Analysis|||||0.4953|-0.8093|0.6370
72562072|NCT01765751|144655337|SUPERIORITY||Mean Difference (Net)|-5.4|||||TWO_SIDED|95.0|-9.8|1.0|||||Pain Interference - High vs. Medium Group - The scale for the PROMIS measures uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population.|Pain Interference||1.0|-9.8|
72562073|NCT01765751|144655337|SUPERIORITY||Mean Difference (Net)|0.8|||||TWO_SIDED|95.0|-2.2|3.8|||||Physical Function - High vs. Low Group - The scale for the PROMIS measures uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population.|Physical Function||3.8|-2.2|
72562074|NCT01765751|144655337|SUPERIORITY||Mean Difference (Net)|0.1|||||TWO_SIDED|95.0|-2.9|3.2|||||Physical Function - Medium vs. Low Group - The scale for the PROMIS measures uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population.|Physical Funtion||3.2|-2.9|
72562075|NCT01765751|144655337|SUPERIORITY||Mean Difference (Net)|0.7|||||TWO_SIDED|95.0|-2.4|3.7|||||Physical Function- High vs. Medium Group - The scale for the PROMIS measures uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population|Physical Function||3.7|-2.4|
72391452|NCT01288235|144290026|OTHER||3-Year Cumulative incidence|14.5|||||TWO_SIDED|95.0|8.3|22.3||||||||22.3|8.3|
72391453|NCT01288235|144290026|OTHER||5-Year Cumulative incidence|20.2|||||TWO_SIDED|95.0|12.7|28.9||||||||28.9|12.7|
72391454|NCT01288235|144290027|OTHER||Mean Difference (Net)|1.1||||0.543|TWO_SIDED|95.0|-2.6|4.9|||t-test, 2 sided|Paired t test||||4.9|-2.6|0.543
72391455|NCT01288235|144290028|OTHER||3-Year Local Disease Control Probability|89.9|||||TWO_SIDED|95.0|83.1|94.9||||||||94.9|83.1|
72391456|NCT01288235|144290028|OTHER||5-Year Local Disease Control Probability|85.9|||||TWO_SIDED|95.0|78.2|91.9||||||||91.9|78.2|
72391457|NCT01288235|144290028|OTHER||3-Year Distant Disease Control|97.0|||||TWO_SIDED|95.0|92.1|99.2||||||||99.2|92.1|
72391458|NCT01288235|144290028|OTHER||5-Year Distant Disease Control|95.0|||||TWO_SIDED|95.0|89.4|98.1||||||||98.1|89.4|
72391459|NCT01288235|144290029|OTHER||3-Year Cumulative incidence of grade 3+|12.2|||||TWO_SIDED|95.0|6.6|19.5||||||||19.5|6.6|
72391460|NCT01288235|144290029|OTHER||5-Year Cumulative incidence of grade 3+|16.3|||||TWO_SIDED|95.0|9.8|24.3||||||||24.3|9.8|
72391461|NCT01288235|144290030|OTHER||3-Year Cumulative inc. of hearing loss|12.5|||||TWO_SIDED|95.0|2.9|29.5||||||||29.5|2.9|
72391462|NCT01288235|144290030|OTHER||5-Year Cumulative inc. of hearing loss|12.5|||||TWO_SIDED|95.0|2.9|29.5||||||||29.5|2.9|
72391463|NCT00291577|144290066|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|98.89||||||90.0|80.34|121.73|||||Ratio percent (%) (Test/Reference) of adjusted geometric means; values have been back-transformed from the log scale.|SU011248 C1D2 vs C2D3. Due to the exploratory nature of the study, no statistical hypothesis testing was done since the primary purpose was to assess the tolerability of the combination of SU011248 with docetaxel.||121.73|80.34|
72562076|NCT01765751|144655337|SUPERIORITY||Mean Difference (Net)|5.8|||||TWO_SIDED|95.0|1.1|10.5|||||Fatigue - High vs. Low Group - The scale for the PROMIS measures uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population.|Fatigue||10.5|1.1|
72451939|NCT01983683|144426256|OTHER||Difference between 2 proportions|-1.6|||||TWO_SIDED|95.0|-6.5|3.3|||||CI for the difference between two proportions are estimated using the Wilson's score method|Exploratory analysis||3.3|-6.5|
72499178|NCT00619957|144528705|SUPERIORITY_OR_OTHER||LS Mean Difference|-15.11||||0.0012|TWO_SIDED|95.0|-24.2|-6.02|||ANOVA|Fixed effects for treatment and pooled center.||A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.||-6.02|-24.20|0.0012
72499179|NCT00619957|144528706|SUPERIORITY_OR_OTHER||LS Mean Difference|-16.37||||0.0003|TWO_SIDED|95.0|-25.24|-7.49|||ANOVA|Fixed effects for treatment and pooled center.||A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.||-7.49|-25.24|0.0003
72499180|NCT00619957|144528707|SUPERIORITY_OR_OTHER||LS Mean Difference|-15.64|||<|0.0001|TWO_SIDED|95.0|-19.29|-11.99|||ANOVA|Fixed effects for treatment and pooled center.||A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.||-11.99|-19.29|<0.0001
72499181|NCT00619957|144528708|SUPERIORITY_OR_OTHER||LS Mean Difference|-21.1|||<|0.0001|TWO_SIDED|95.0|-25.61|-16.59|||ANOVA|Fixed effects for treatment and pooled center.||A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.||-16.59|-25.61|<0.0001
72562077|NCT01765751|144655337|SUPERIORITY||Median Difference (Net)|3.3|||||TWO_SIDED|95.0|-1.5|8.2|||||Fatigue - Medium vs. Low Group - The scale for the PROMIS measures uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population.|Fatigue||8.2|-1.5|
72562078|NCT01765751|144655337|SUPERIORITY||Mean Difference (Net)|2.5|||||TWO_SIDED|95.0|-2.3|7.3|||||Fatigue - High vs. Medium Group - The scale for the PROMIS measures uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population.|Fatigue||7.3|-2.3|
72451940|NCT01983683|144426257|OTHER||Difference between 2 proportions|8.8|||||TWO_SIDED|95.0|1.1|16.4|||||CI for the difference between two proportions are estimated using the Wilson's score method|Exploratory analysis||16.4|1.1|
72451941|NCT01983683|144426258|SUPERIORITY|Sensitivity analysis|Difference between 2 proportions|2.7|||||TWO_SIDED|95.0|-5.5|10.9|||||CI for the difference between two proportions are estimated using the Wilson's score method|||10.9|-5.5|
72451942|NCT03400150|144426262|OTHER|||||||0.025|TWO_SIDED|95.0|||||Farrington-Manning|||||||0.025
72451943|NCT05501600|144426263|SUPERIORITY|||||||0.004|||||||Regression, Linear|||||||0.004
72451944|NCT05501600|144426264|SUPERIORITY|||||||0.081616|||||||t-test, 2 sided|||||||0.081616
72451945|NCT04039113|144426272|SUPERIORITY||Rate Ratio|0.83||||0.1042|TWO_SIDED|90.0|0.64|1.06||1-sided p-value|Negative Binomial|||||1.06|0.64|0.1042
72451946|NCT04039113|144426272|SUPERIORITY||Rate Ratio|0.83||||0.2085|TWO_SIDED|95.0|0.61|1.11||2-sided p-value|Negative Binomial|||||1.11|0.61|0.2085
72451947|NCT00220805|144426336|SUPERIORITY_OR_OTHER|||||||0.49|TWO_SIDED|95.0|||||ANOVA|||The primary efficacy comparison for the change in LogMAR from baseline to endpoint was a two-way analysis of variance (ANOVA) with treatment group and center as fixed factors (main effect model).||||0.49
72622441|NCT02181413|144774855|SUPERIORITY||Hazard Ratio (HR)|1.179|||||TWO_SIDED|95.0|0.959|1.45|||||Hazard ratio is based on an unadjusted Cox's proportional hazard regression model stratified by induction regimen, pre-induction ISS, and response after transplantation, comparing the hazard rate of Ixazomib arm over the hazard rate of Placebo arm.|||1.450|0.959|
72622442|NCT02181413|144774857|SUPERIORITY|||||||0.814||||||P-value was based on Fisher's exact test comparing conversion to MRD- at any time post study entry between treatment groups.|Fisher Exact|||||||0.814
72451948|NCT00220805|144426337|SUPERIORITY_OR_OTHER|||||||0.76|TWO_SIDED|||||Adjusted for centers (including a Breslow-Day test for homogeneity of odd ratios across centers)|Cochran-Mantel-Haenszel|||||||0.76
72622443|NCT02181413|144774858|SUPERIORITY|||||||0.805||||||P-value was based on fisher's exact test comparing conversion to MRD- at any time post study entry between treatment groups.|Fisher Exact|||||||0.805
72451949|NCT00220805|144426338|SUPERIORITY_OR_OTHER|||||||0.13|TWO_SIDED||||||Cochran-Mantel-Haenszel|Adjusted for centers (including a Breslow-Day test for homogeneity of odd ratios across centers)||||||0.13
72451950|NCT00220805|144426339|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01||||0.9|TWO_SIDED|95.0|-0.21|0.19|||ANOVA|||||0.19|-0.21|0.90
72451951|NCT00220805|144426341|SUPERIORITY_OR_OTHER|||||||0.74|TWO_SIDED||||||Cochran-Mantel-Haenszel|Adjusted to centers||||||0.74
72451952|NCT00754065|144426351|SUPERIORITY_OR_OTHER_LEGACY||F-statistic|9.3218||||0.0024||||||Comparison of EV/DNG vs. EE/NGM|ANOVA|||2-way ANOVA model with treatment and pain strata (headache and pelvic pain) as factors||||0.0024
72451953|NCT01074294|144426468|SUPERIORITY||Mean Difference (Final Values)|0.69||||0.5845|TWO_SIDED|95.0|-1.8|3.19||The p-value was derived using MMRM method with treatment, trial center, visit week, and treatment by visit week interaction as class effects and Week 5 value as covariate.|Mixed Models Analysis||The difference between Least Squares (LS) means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|||3.19|-1.80|0.5845
72451954|NCT01074294|144426469|SUPERIORITY||Mean Difference (Final Values)|-0.09||||0.8832|TWO_SIDED|95.0|-1.37|1.18||The p-value was derived using ANCOVA model with treatment and trial center as main effects and Week 5 value as covariate.|ANCOVA||The difference between LS means derived from the ANCOVA model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|||1.18|-1.37|0.8832
72619881|NCT01539525|144770911|SUPERIORITY_OR_OTHER||Slope|0.012|STANDARD_ERROR_OF_MEAN|0.0005||0.01|TWO_SIDED|95.0|0.002|0.021||P-value adjusted for multiple comparisons using Holm's step-down multiple testing procedure. The a priori threshold for statistical significance was p \< 0.025.|Generalized Estimating Equation|adjusted for stratifying variables- primary substance and pregnancy status|Estimated parameter is treatment x quadratic time interaction term coefficient- Motivational Interview- Computer vs. Treatment as Usual|Differences in days/month of primary substance use over time between treatment groups were examined using generalized estimating equations (GEE). We specified a negative binomial distribution to account for overdispersion in days/month of primary substance use, a log link function, and a first-order autoregressive working correlation structure. β coefficients were estimated using quasi-likelihood estimation methods and sandwich/empirical standard errors were calculated.||0.021|0.002|0.010
72619882|NCT01539525|144770912|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.931||||0.81|TWO_SIDED|95.0|0.559|1.551|||Regression, Logistic|adjusted for stratifying variables- primary substance and pregnancy status|Estimated odds ratio is for Motivational Interview- Nurse vs. Treatment as Usual|||1.551|0.559|0.810
72619883|NCT01539525|144770912|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.968||||0.99|TWO_SIDED|95.0|0.579|1.617|||Regression, Logistic|adjusted for stratifying variables- primary substance and pregnancy status|Estimated odds ratio is for Motivational Interview- Computer vs. Treatment as Usual|||1.617|0.579|0.990
72619884|NCT01539525|144770913|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.258||||0.465|TWO_SIDED|95.0|0.409|3.871|||Regression, Logistic|adjusted for stratifying variables- primary drug and pregnancy status|odds ratio estimate is for Motivational Interview- Nurse vs. Treatment as Usual|||3.871|0.409|0.465
72619885|NCT01539525|144770913|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.749||||0.49|TWO_SIDED|95.0|0.205|2.732|||Regression, Logistic||Odds ratio estimate is for Motivational Interview- Computer vs. Treatment as Usual|||2.732|0.205|0.490
72619886|NCT01712074|144770915|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.695|STANDARD_ERROR_OF_MEAN|0.8697||0.4256|TWO_SIDED|80.0|-0.424|1.814|||Mixed Models Analysis|||||1.814|-0.424|0.4256
72619887|NCT01712074|144770916|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.194|STANDARD_ERROR_OF_MEAN|1.7149||0.2027|TWO_SIDED|80.0|-0.013|4.401|||Mixed Models Analysis|||||4.401|-0.013|0.2027
72619888|NCT02474901|144770946|EQUIVALENCE|Looked for statistically-significant difference in numbers of adverse events between the two groups, used a p-value of 0.05 as the cutoff value for significance.|||||<|0.05|||||||Chi-squared, Corrected|Groups were compared with Yates-corrected chi-square test or Fisher exact test for binary or categorical variables.||||||<0.05
72451955|NCT01074294|144426470|SUPERIORITY||Mean Difference (Final Values)|0.57||||0.3864|TWO_SIDED|95.0|-0.72|1.86||The p-value was derived using MMRM method with treatment, trial center, visit week, and treatment by visit week interaction as class effects and Week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|||1.86|-0.72|0.3864
72619889|NCT02539394|144770949|EQUIVALENCE|43 patient in each group need to achieved \>80% power to detect a 15 point differences in SWAL-QOL survey||||||0.394|||||||Wilcoxon (Mann-Whitney)|||The distribution of Pre-operative SWAL-QOL - Burden is the same across the 2 arms||||0.394
72451956|NCT01074294|144426471|SUPERIORITY||Mean Difference (Final Values)|0.34||||0.0061|TWO_SIDED|95.0|0.1|0.58||The p value was derived using MMRM method with treatment, trial center, visit week, and treatment by visit week interaction as class effects and Week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|||0.58|0.10|0.0061
72451957|NCT01074294|144426472|SUPERIORITY||Mean Difference (Final Values)|0.41||||0.6932|TWO_SIDED|95.0|-1.64|2.46||The p-value was derived from ANCOVA model, with treatment and trial center as main effects and Week 5 value as covariate.|ANCOVA||This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|||2.46|-1.64|0.6932
72451958|NCT01074294|144426473|SUPERIORITY||Mean Difference (Final Values)|0.81||||0.2781|TWO_SIDED|95.0|-0.66|2.28||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 6||2.28|-0.66|0.2781
72451959|NCT01074294|144426473|SUPERIORITY||Mean Difference (Final Values)|0.67||||0.4673|TWO_SIDED|95.0|-1.15|2.49||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 7||2.49|-1.15|0.4673
72619890|NCT02539394|144770949|EQUIVALENCE|43 patient in each group need to achieved \>80% power to detect a 15 point differences in SWAL-QOL survey||||||0.017|||||||Wilcoxon (Mann-Whitney)|||The distribution of POD1 SWAL-QOL - Burden is the same across the 2 arms||||0.017
72619891|NCT02539394|144770949|EQUIVALENCE|43 patient in each group need to achieved \>80% power to detect a 15 point differences in SWAL-QOL survey||||||0.015|||||||Wilcoxon (Mann-Whitney)|||The distribution of POD2 SWAL-QOL - Burden is the same across the 2 arms||||0.015
72619892|NCT02539394|144770949|EQUIVALENCE|43 patient in each group need to achieved \>80% power to detect a 15 point differences in SWAL-QOL survey||||||0.125|||||||Wilcoxon (Mann-Whitney)|||The distribution of 4-6 weeks SWAL-QOL - Burden is the same across the 2 arms||||0.125
72619893|NCT02539394|144770950|EQUIVALENCE|43 patient in each group need to achieved \>80% power to detect a 15 point differences in SWAL-QOL survey||||||0.043|||||||Wilcoxon (Mann-Whitney)|||The distribution of Pre-operative SWAL-QOL - Eating desire is the same across the 2 arms||||0.043
72619894|NCT02539394|144770950|EQUIVALENCE|43 patient in each group need to achieved \>80% power to detect a 15 point differences in SWAL-QOL survey||||||0.606|||||||Wilcoxon (Mann-Whitney)|||The distribution of POD1 SWAL-QOL - Eating desire is the same across the 2 arms||||0.606
72562079|NCT01765751|144655337|SUPERIORITY||Mean Difference (Net)|1.3|||||TWO_SIDED|95.0|-0.9|3.5|||||Sleep Disturbance - High vs. Low Group - The scale for the PROMIS measures uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population.|Sleep Disturbance||3.5|-0.9|
72562080|NCT01765751|144655337|SUPERIORITY||Mean Difference (Net)|-1.4|||||TWO_SIDED|95.0|-3.6|0.9|||||Sleep Disturbance - Medium vs. Low Group - The scale for the PROMIS measures uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population.|Sleep Disturbance||0.9|-3.6|
72562081|NCT01765751|144655337|SUPERIORITY||Mean Difference (Net)|2.7|||||TWO_SIDED|95.0|0.4|5.0|||||Sleep Disturbance - High vs. Medium Group - The scale for the PROMIS measures uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population.|Sleep Disturbance||5.0|0.4|
72562082|NCT01765751|144655337|SUPERIORITY||Mean Difference (Net)|-0.3|||||TWO_SIDED|95.0|-4.5|3.9|||||Anxiety - High vs. Low Group - The scale for the PROMIS measures uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population.|Anxiety||3.9|-4.5|
72562083|NCT01765751|144655337|SUPERIORITY||Mean Difference (Net)|1.1|||||TWO_SIDED|95.0|-2.9|5.1|||||Anxiety - Medium vs. Low Group - The scale for the PROMIS measures uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population.|Anxiety||5.1|-2.9|
72562084|NCT01765751|144655337|SUPERIORITY||Mean Difference (Net)|-1.4|||||TWO_SIDED|95.0|-5.7|2.9|||||Anxiety - High vs. Medium Group - The scale for the PROMIS measures uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population.|Anxiety||2.9|-5.7|
72562085|NCT01765751|144655337|SUPERIORITY||Mean Difference (Net)|-2.8|||||TWO_SIDED|95.0|-6.7|0.6|||||Depression - High vs. Low Group - The scale for the PROMIS measures uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population.|Depression||0.6|-6.7|
72562086|NCT01765751|144655337|SUPERIORITY||Mean Difference (Net)|-0.8|||||TWO_SIDED|95.0|-4.1|2.6|||||Depression - Medium vs. Low Group - The scale for the PROMIS measures uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population.|Depression||2.6|-4.1|
72451960|NCT01074294|144426473|SUPERIORITY||Mean Difference (Final Values)|0.62||||0.5719|TWO_SIDED|95.0|-1.54|2.79||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 8||2.79|-1.54|0.5719
72451961|NCT01074294|144426473|SUPERIORITY||Mean Difference (Final Values)|0.56||||0.6262|TWO_SIDED|95.0|-1.7|2.83||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 9||2.83|-1.70|0.6262
72562087|NCT01765751|144655337|SUPERIORITY||Mean Difference (Net)|-2.0|||||TWO_SIDED|95.0|-5.4|1.4|||||Depression - High vs. Medium Group - The scale for the PROMIS measures uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population.|Depression||1.4|-5.4|
72451962|NCT01074294|144426473|SUPERIORITY||Mean Difference (Final Values)|1.4||||0.2638|TWO_SIDED|95.0|-1.06|3.87||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 10||3.87|-1.06|0.2638
72562088|NCT01765751|144655337|SUPERIORITY||Mean Difference (Net)|0.2|||||TWO_SIDED|95.0|-4.5|4.9|||||Satisfaction with Social Role - High vs. Low Group - The scale for the PROMIS measures uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population.|Satisfaction with Social Role||4.9|-4.5|
72562089|NCT01765751|144655337|SUPERIORITY||Mean Difference (Net)|3.0|||||TWO_SIDED|95.0|-1.8|7.7|||||Satisfaction with Social Role - Medium vs. Low Group - The scale for the PROMIS measures uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population.|Satisfaction with Social Role||7.7|-1.8|
72562090|NCT01765751|144655337|SUPERIORITY||Mean Difference (Net)|-2.8|||||TWO_SIDED|95.0|-7.6|2.0|||||Satisfaction with Social Role - High vs. Medium Group - The scale for the PROMIS measures uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population.|Satisfaction with Social Role||2.0|-7.6|
72562091|NCT01848210|144655349|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.65||||0.531|TWO_SIDED|95.0|-19.81|10.51|||Regression, Linear|||||10.51|-19.81|0.531
72562092|NCT01503333|144655370|EQUIVALENCE|Linear mixed-effect models were applied to examine the intervention effect on MVPA at post-intervention. Models included the group variable, cluster random effect of school, and the following fixed effects: age, BMI z-score, race, SES, ethnicity, pubertal stage, and study year. Baseline MVPA was included when evaluating the intervention effect at post-intervention.|parameter estimate|-0.08||||0.207|TWO_SIDED|95.0|-0.21|0.05|||Mixed Models Analysis|||Hypotheses: Post-intervention, weighted mean minutes of MVPA/week will be greater by 16 minutes among girls in intervention than control schools. Mean minutes per week is determined by multiplying mean minutes/hour by 90 hours that girls are awake in a week (10 hours awake on each weekend day; 14 hours awake on each weekday).||0.05|-0.21|.207
72562093|NCT01503333|144655371|EQUIVALENCE|Linear mixed models were used to analyze intervention effect on CV fitness according to intention-to-treat, with school pairs treated as random effect and students nested within school and treatment condition. Models included main intervention predictor (control or intervention), incorporated cluster random effect, specified school pairs (random intercept), and controlled for baseline CV fitness, physical activity, race, socioeconomic status, ethnicity, pubertal stage, and study year cohort.|parameter estimate|0.2|STANDARD_ERROR_OF_MEAN|0.08||0.018|TWO_SIDED|95.0|0.03|0.36|||Mixed Models Analysis|||Immediately post-intervention, cardiovascular (CV) fitness will be higher among girls in the intervention than control schools.||0.36|0.03|.018
72562094|NCT01503333|144655372|OTHER|Linear mixed models were used to analyze intervention effect on BMI-z according to intention-to-treat, with school pairs treated as random effect and students nested within school and treatment condition. Models for BMI-z included main intervention predictor (control or intervention), incorporated cluster random effect, specified school pairs (random intercept), and controlled for baseline BMI-z, physical activity, race, socioeconomic status, ethnicity, pubertal stage, and study year cohort.|parameter estimate|-0.02|STANDARD_ERROR_OF_MEAN|0.01||0.191|TWO_SIDED|95.0|-0.05|0.01|||Mixed Models Analysis|||Immediately post-intervention, BMI z-score will be significantly lower among girls in the intervention than control schools.||0.01|-0.05|.191
72562095|NCT01503333|144655373|EQUIVALENCE|Linear mixed models were used to analyze intervention effect on % body fat according to intention-to-treat, with school pairs treated as random effect and students nested within school and treatment condition. Models included main intervention predictor (control or intervention), incorporated cluster random effect, specified school pairs (random intercept), and controlled for baseline % body fat, age, physical activity, race, socioeconomic status, ethnicity, pubertal stage, and year cohort.|parameter estimate|-0.37|STANDARD_ERROR_OF_MEAN|0.14||0.007|TWO_SIDED|95.0|-0.64|-0.1|||Mixed Models Analysis|||Immediately post-intervention, percent body fat will be significantly lower among girls in the intervention than control schools.||-0.10|-0.64|.007
72562096|NCT01503333|144655374|EQUIVALENCE|Linear mixed-effect models were applied to examine the intervention effect on MVPA at 9-month follow up. Models included the group variable, cluster random effect of school, and the following fixed effects: age, BMI z-score, race, SES, ethnicity, pubertal stage, and study year. Baseline MVPA was included when evaluating the intervention effect at follow up.|parameter estimate|-0.09||||0.118|TWO_SIDED|95.0|-0.21|0.02|||Mixed Models Analysis|||||0.02|-0.21|.118
72562097|NCT01503333|144655375|OTHER||parameter estimate|-0.97|||||TWO_SIDED|||||||||Path analysis was performed to examine study mediation model. Maximum likelihood estimates were computed. Model fit was evaluated based on fit indices: (a) Goodness-of-Fit Index (GFI) ≥.95, (b) Comparative Fit Index (CFI) ≥.95, (c) Root Mean Square Error of Approximation (RMSEA) ≤.05; (d) standardized root mean squared residual (SRMR) ≤.08; and (e) chi-square test p\>.05.26.||||
72562098|NCT01503333|144655376|OTHER||parameter estimate|2.9|||||TWO_SIDED|||||||||Path analysis was performed to examine study mediation model. Maximum likelihood estimates were computed. Model fit was evaluated based on fit indices: (a) Goodness-of-Fit Index (GFI) ≥.95, (b) Comparative Fit Index (CFI) ≥.95, (c) Root Mean Square Error of Approximation (RMSEA) ≤.05; (d) standardized root mean squared residual (SRMR) ≤.08; and (e) chi-squar||||
72451963|NCT01074294|144426474|SUPERIORITY||Mean Difference (Final Values)|0.42||||0.3804|TWO_SIDED|95.0|-0.52|1.37||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 6||1.37|-0.52|0.3804
72451964|NCT01074294|144426474|SUPERIORITY||Mean Difference (Final Values)|0.26||||0.6422|TWO_SIDED|95.0|-0.86|1.39||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 7||1.39|-0.86|0.6422
72451965|NCT01074294|144426474|SUPERIORITY||Mean Difference (Final Values)|0.28||||0.6707|TWO_SIDED|95.0|-1.0|1.55||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 8||1.55|-1.00|0.6707
72451966|NCT01074294|144426474|SUPERIORITY||Mean Difference (Final Values)|0.3||||0.6638|TWO_SIDED|95.0|-1.04|1.64||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 9||1.64|-1.04|0.6638
72619895|NCT02539394|144770950|EQUIVALENCE|43 patient in each group need to achieved \>80% power to detect a 15 point differences in SWAL-QOL survey||||||0.155|||||||Wilcoxon (Mann-Whitney)|||The distribution of POD2 SWAL-QOL - Eating desire is the same across the 2 arms||||0.155
72619896|NCT02539394|144770950|EQUIVALENCE|43 patient in each group need to achieved \>80% power to detect a 15 point differences in SWAL-QOL survey||||||0.019|||||||Wilcoxon (Mann-Whitney)|||The distribution of 4-6 weeks SWAL-QOL - Eating desire is the same across the 2 arms||||0.019
72451967|NCT01074294|144426474|SUPERIORITY||Mean Difference (Final Values)|0.9||||0.2252|TWO_SIDED|95.0|-0.56|2.36||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 10||2.36|-0.56|0.2252
72451968|NCT01074294|144426474|SUPERIORITY||Mean Difference (Final Values)|0.28||||0.697|TWO_SIDED|95.0|-1.14|1.7||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 11||1.70|-1.14|0.6970
72451969|NCT01074294|144426475|SUPERIORITY||Mean Difference (Final Values)|0.23||||0.6008|TWO_SIDED|95.0|-0.64|1.11||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 6||1.11|-0.64|0.6008
72619897|NCT02539394|144770951|EQUIVALENCE|43 patient in each group need to achieved \>80% power to detect a 15 point differences in SWAL-QOL survey||||||0.25|||||||Wilcoxon (Mann-Whitney)|||The distribution of Pre-operative SWAL-QOL - Eating duration is the same across the 2 arms||||0.250
72451970|NCT01074294|144426475|SUPERIORITY||Mean Difference (Final Values)|0.28||||0.5859|TWO_SIDED|95.0|-0.72|1.27||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 7||1.27|-0.72|0.5859
72451971|NCT01074294|144426475|SUPERIORITY||Mean Difference (Final Values)|0.19||||0.7406|TWO_SIDED|95.0|-0.96|1.34||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 8||1.34|-0.96|0.7406
72562099|NCT01503333|144655377|OTHER||parameter estimate|0.47|||||TWO_SIDED|||||||||Path analysis was performed to examine study mediation model. Maximum likelihood estimates were computed. Model fit was evaluated based on fit indices: (a) Goodness-of-Fit Index (GFI) ≥.95, (b) Comparative Fit Index (CFI) ≥.95, (c) Root Mean Square Error of Approximation (RMSEA) ≤.05; (d) standardized root mean squared residual (SRMR) ≤.08; and (e) chi-squar||||
72562100|NCT01503333|144655378|OTHER||parameter estimate|30.48|||<|0.001|TWO_SIDED||||||Path analysis|||Path analysis was performed to examine study mediation model. Maximum likelihood estimates were computed. Model fit was evaluated based on fit indices: (a) Goodness-of-Fit Index (GFI) ≥.95, (b) Comparative Fit Index (CFI) ≥.95, (c) Root Mean Square Error of Approximation (RMSEA) ≤.05; (d) standardized root mean squared residual (SRMR) ≤.08; and (e) chi-squar||||<.001
72562101|NCT01503333|144655379|OTHER||parameter estimate|24.48|||<|0.001|TWO_SIDED||||||Path analysis|||Path analysis was performed to examine study mediation model. Maximum likelihood estimates were computed. Model fit was evaluated based on fit indices: (a) Goodness-of-Fit Index (GFI) ≥.95, (b) Comparative Fit Index (CFI) ≥.95, (c) Root Mean Square Error of Approximation (RMSEA) ≤.05; (d) standardized root mean squared residual (SRMR) ≤.08; and (e) chi-squar||||<.001
72562102|NCT01503333|144655380|OTHER||parameter estimate|3.19|||||TWO_SIDED|||||||||Path analysis was performed to examine study mediation model. Maximum likelihood estimates were computed. Model fit was evaluated based on fit indices: (a) Goodness-of-Fit Index (GFI) ≥.95, (b) Comparative Fit Index (CFI) ≥.95, (c) Root Mean Square Error of Approximation (RMSEA) ≤.05; (d) standardized root mean squared residual (SRMR) ≤.08; and (e) chi-squar||||
72451972|NCT01074294|144426475|SUPERIORITY||Mean Difference (Final Values)|0.12||||0.8568|TWO_SIDED|95.0|-1.14|1.37||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 9||1.37|-1.14|0.8568
72562103|NCT02327325|144655419|SUPERIORITY||Mean Difference (Final Values)|-2.94||||0.08|TWO_SIDED|95.0|-6.24|0.35|||Mixed Models Analysis|||This is the comparison between physical activity only and the wait list group. Rejection of the null hypothesis means that the physical activity group had greater improvement than the wait list group.||0.35|-6.24|0.08
72562104|NCT02327325|144655419|SUPERIORITY||Mean Difference (Final Values)|-3.26||||0.06|TWO_SIDED|95.0|-6.69|0.06|||Mixed Models Analysis|||This is the comparison of the PA \& CBT group to the wait list group. Rejection of the null hypothesis means that the PA + CBT group was superior on this outcome to the wait list group.||0.06|-6.69|0.06
72619898|NCT02539394|144770951|EQUIVALENCE|43 patient in each group need to achieved \>80% power to detect a 15 point differences in SWAL-QOL survey||||||0.478|||||||Wilcoxon (Mann-Whitney)|||The distribution of POD1 SWAL-QOL - Eating duration is the same across the 2 arms||||0.478
72619899|NCT02539394|144770951|EQUIVALENCE|43 patient in each group need to achieved \>80% power to detect a 15 point differences in SWAL-QOL survey||||||0.019|||||||Wilcoxon (Mann-Whitney)|||The distribution of POD2 SWAL-QOL - Eating duration is the same across the 2 arms||||0.019
72619900|NCT02539394|144770951|EQUIVALENCE|43 patient in each group need to achieved \>80% power to detect a 15 point differences in SWAL-QOL survey||||||0.049|||||||Wilcoxon (Mann-Whitney)|||The distribution of 4-6 weeks SWAL-QOL - Eating duration is the same across the 2 arms||||0.049
72619901|NCT02539394|144770952|EQUIVALENCE|43 patient in each group need to achieved \>80% power to detect a 15 point differences in SWAL-QOL survey||||||0.376|||||||Wilcoxon (Mann-Whitney)|||The distribution of Pre-operative SWAL-QOL - Food selection is the same across the 2 arms||||0.376
72619902|NCT02539394|144770952|EQUIVALENCE|43 patient in each group need to achieved \>80% power to detect a 15 point differences in SWAL-QOL survey||||||0.013|||||||Wilcoxon (Mann-Whitney)|||The distribution of POD1 SWAL-QOL - Food selection is the same across the 2 arms||||0.013
72619903|NCT02539394|144770952|EQUIVALENCE|43 patient in each group need to achieved \>80% power to detect a 15 point differences in SWAL-QOL survey||||||0.049|||||||Wilcoxon (Mann-Whitney)|||The distribution of POD2 SWAL-QOL - Food selection is the same across the 2 arms||||0.049
72619904|NCT02539394|144770952|EQUIVALENCE|43 patient in each group need to achieved \>80% power to detect a 15 point differences in SWAL-QOL survey||||||0.3|||||||Wilcoxon (Mann-Whitney)|||The distribution of 4-6 weeks SWAL-QOL - Food selection is the same across the 2 arms||||0.300
72619905|NCT02539394|144770953|EQUIVALENCE|43 patient in each group need to achieved \>80% power to detect a 15 point differences in SWAL-QOL survey||||||0.037|||||||Wilcoxon (Mann-Whitney)|||The distribution of Pre-operative SWAL-QOL - Communication is the same across the 2 arms||||0.037
72619906|NCT02539394|144770953|EQUIVALENCE|43 patient in each group need to achieved \>80% power to detect a 15 point differences in SWAL-QOL survey||||||0.858|||||||Wilcoxon (Mann-Whitney)|||The distribution of POD1 SWAL-QOL - Communication is the same across the 2 arms||||0.858
72619907|NCT02539394|144770953|EQUIVALENCE|43 patient in each group need to achieved \>80% power to detect a 15 point differences in SWAL-QOL survey||||||0.042|||||||Wilcoxon (Mann-Whitney)|||The distribution of POD2 SWAL-QOL - Communication is the same across the 2 arms||||0.042
72619908|NCT02539394|144770953|EQUIVALENCE|43 patient in each group need to achieved \>80% power to detect a 15 point differences in SWAL-QOL survey||||||0.031|||||||Wilcoxon (Mann-Whitney)|||The distribution of 4-6 weeks SWAL-QOL - Communication is the same across the 2 arms||||0.031
72619909|NCT02539394|144770954|EQUIVALENCE|43 patient in each group need to achieved \>80% power to detect a 15 point differences in SWAL-QOL survey||||||0.343|||||||Wilcoxon (Mann-Whitney)|||The distribution of Pre-operative SWAL-QOL - Fear swallow is the same across the 2 arms||||0.343
72562105|NCT02327325|144655420|SUPERIORITY||Mean Difference (Net)|-6.11||||0.07|TWO_SIDED|95.0|-12.85|0.64|||Mixed Models Analysis|||This is the comparison of the PA only group with the wait list control. Rejection of the null hypothesis means that the PA group was superior to the wait list group.||0.64|-12.85|0.07
72562106|NCT02327325|144655420|SUPERIORITY||Mean Difference (Final Values)|-4.1||||0.28|TWO_SIDED|95.0|-11.69|3.48|||Mixed Models Analysis|||This is the comparison of the PA + CBT only group with the wait list control. Rejection of the null hypothesis means that the PA + CBT group was superior to the wait list group.||3.48|-11.69|0.28
72562107|NCT02327325|144655421|SUPERIORITY||Mean Difference (Final Values)|3.64||||0.097|TWO_SIDED|95.0|-0.69|7.96|||Mixed Models Analysis|||This is the comparison of the PA only group with the wait list control. Rejection of the null hypothesis means that the PA group was superior to the wait list group.||7.96|-0.69|0.097
72562108|NCT02327325|144655421|SUPERIORITY||Mean Difference (Final Values)|2.91||||0.196|TWO_SIDED|95.0|-1.55|7.39|||Mixed Models Analysis|||This is the comparison of the PA+CBT group with the wait list control. Rejection of the null hypothesis means that the PA+CBT group was superior to the wait list group.||7.39|-1.55|0.196
72562109|NCT02327325|144655422|SUPERIORITY||Mean Difference (Final Values)|-4.1|||<|0.01|TWO_SIDED|95.0|-6.85|-1.34|||Mixed Models Analysis|||This is the comparison of the PA only group with the wait list control. Rejection of the null hypothesis means that the PA group was superior to the wait list group.||-1.34|-6.85|<0.01
72562110|NCT02327325|144655422|SUPERIORITY||Mean Difference (Final Values)|-1.99||||0.17|TWO_SIDED|95.0|-4.85|0.86|||Mixed Models Analysis|||This is the comparison of the PA + CBT only group with the wait list control. Rejection of the null hypothesis means that the PA + CBT group was superior to the wait list group.||0.86|-4.85|0.17
72451973|NCT01074294|144426475|SUPERIORITY||Mean Difference (Final Values)|0.34||||0.6044|TWO_SIDED|95.0|-0.96|1.64||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 10||1.64|-0.96|0.6044
72451974|NCT01074294|144426475|SUPERIORITY||Mean Difference (Final Values)|0.29||||0.6772|TWO_SIDED|95.0|-1.08|1.66||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 11||1.66|-1.08|0.6772
72451975|NCT01074294|144426476|SUPERIORITY||Mean Difference (Final Values)|0.14||||0.7881|TWO_SIDED|95.0|-0.87|1.15||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 6||1.15|-0.87|0.7881
72562111|NCT02327325|144655423|SUPERIORITY||Median Difference (Final Values)|0.16||||0.95|TWO_SIDED|95.0|-4.86|5.19|||Mixed Models Analysis|||This is the comparison of the PA only group with the wait list control. Rejection of the null hypothesis means that the PA group was superior to the wait list group.||5.19|-4.86|0.95
72562112|NCT02327325|144655423|SUPERIORITY||Mean Difference (Final Values)|0.11||||0.97|TWO_SIDED|95.0|-7.07|1.07|||Mixed Models Analysis|||This is the comparison of the PA+CBT group with the wait list control. Rejection of the null hypothesis means that the PA+CBT group was superior to the wait list group.||1.07|-7.07|0.97
72562113|NCT04443569|144655428|SUPERIORITY|||||||0.3|||||||t-test, 2 sided|||Post-Op Day 1||||0.3
72562114|NCT04443569|144655428|SUPERIORITY|||||||0.9|||||||t-test, 2 sided|||Post-Op Day 2||||0.9
72562115|NCT04443569|144655428|SUPERIORITY|||||||0.07|||||||t-test, 2 sided|||Post-Op Day 3||||0.07
72562116|NCT04443569|144655428|SUPERIORITY|||||||0.09|||||||t-test, 2 sided|||Post-Op Day 4||||0.09
72562117|NCT04443569|144655429|SUPERIORITY|||||||0.02|||||||t-test, 2 sided|||||||0.02
72562118|NCT00996437|144655430|SUPERIORITY_OR_OTHER||Treatment Difference in Cumulative Prob|4.0||||0.37|TWO_SIDED|95.0|-4.0|13.0|||Log Rank|After adjusting for potential confounding factors, time to vitrectomy remained similar between treatment groups.||The cumulative probabilities of vitrectomy by 16 weeks in each group were computed using the life-table method. Treatment group comparisons were performed using the log-rank test. The treatment difference in cumulative probabilities and 95% confidence interval were reported.||13|-4|0.37
72562119|NCT00996437|144655431|SUPERIORITY_OR_OTHER|||||||0.01||95.0||||P-value corresponds with recurrent vitreous hemorrhage evaluated on clinical exam between the two treatment arms.|Fisher Exact|||||||0.01
72562120|NCT00996437|144655432|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.54||||0.05|TWO_SIDED|95.0|1.03|2.3|||Log Rank|||||2.30|1.03|0.05
72562121|NCT00996437|144655433|SUPERIORITY_OR_OTHER|||||||0.87||95.0||||P-value corresponds to the 12 week visit treatment comparison.|GLM with GEE method|Number of subjects with baseline OCT ss=0 and OCT ss\>0 and no vitrectomy at follow up. A generalized GLM with GEE was used for treatment comparisons.||Signal strength was analyzed as a composite outcome defined as OCT signal strength \> = and no vitrectomy vs. OCT signal strength = 0.||||0.87
72562122|NCT00996437|144655434|SUPERIORITY_OR_OTHER|||||||0.04||95.0||||P-value corresponds to the 12 week visit treatment comparison.|Mixed Models Analysis|Treatment comparisons were performed using a longitudinal mixed model adjusting for baseline visual acuity.||||||.04
72619910|NCT02539394|144770954|EQUIVALENCE|43 patient in each group need to achieved \>80% power to detect a 15 point differences in SWAL-QOL survey||||||0.022|||||||Wilcoxon (Mann-Whitney)|||The distribution of POD1 SWAL-QOL - Fear swallow is the same across the 2 arms||||0.022
72619911|NCT02539394|144770954|EQUIVALENCE|43 patient in each group need to achieved \>80% power to detect a 15 point differences in SWAL-QOL survey||||||0.018|||||||Wilcoxon (Mann-Whitney)|||The distribution of POD2 SWAL-QOL - Fear swallow is the same across the 2 arms||||0.018
72619912|NCT02539394|144770954|EQUIVALENCE|43 patient in each group need to achieved \>80% power to detect a 15 point differences in SWAL-QOL survey||||||0.008|||||||Wilcoxon (Mann-Whitney)|||The distribution of 4-6 weeks SWAL-QOL - Fear swallow is the same across the 2 arms||||0.008
72619913|NCT02539394|144770955|EQUIVALENCE|43 patient in each group need to achieved \>80% power to detect a 15 point differences in SWAL-QOL survey||||||0.28|||||||Wilcoxon (Mann-Whitney)|||The distribution of Pre-operative SWAL-QOL - Social is the same across the 2 arms||||0.280
72391464|NCT00291577|144290066|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|81.96||||||90.0|59.76|112.41|||||Ratio percent (%) (Test/Reference) of adjusted geometric means; values have been back-transformed from the log scale.|SU012662 C1D2 vs C2D3||112.41|59.76|
72451976|NCT01074294|144426476|SUPERIORITY||Mean Difference (Final Values)|-0.09||||0.8841|TWO_SIDED|95.0|-1.38|1.19||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 7||1.19|-1.38|0.8841
72451977|NCT01074294|144426476|SUPERIORITY||Mean Difference (Final Values)|-0.22||||0.7589|TWO_SIDED|95.0|-1.61|1.17||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 8||1.17|-1.61|0.7589
72451978|NCT01074294|144426476|SUPERIORITY||Mean Difference (Final Values)|0.46||||0.5375|TWO_SIDED|95.0|-1.01|1.93||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 9||1.93|-1.01|0.5375
72451979|NCT01074294|144426476|SUPERIORITY||Mean Difference (Final Values)|0.58||||0.4456|TWO_SIDED|95.0|-0.92|2.08||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 10||2.08|-0.92|0.4456
72451980|NCT01074294|144426476|SUPERIORITY||Mean Difference (Final Values)|0.34||||0.667|TWO_SIDED|95.0|-1.21|1.89||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 11||1.89|-1.21|0.6670
72451981|NCT01074294|144426477|SUPERIORITY||Mean Difference (Final Values)|0.02||||0.9708|TWO_SIDED|95.0|-0.97|1.01||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 7||1.01|-0.97|0.9708
72451982|NCT01074294|144426477|SUPERIORITY||Mean Difference (Final Values)|0.49||||0.397|TWO_SIDED|95.0|-0.65|1.63||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 9||1.63|-0.65|0.3970
72451983|NCT01074294|144426478|SUPERIORITY||Risk Ratio (RR)|1.01||||0.9568|TWO_SIDED|95.0|0.68|1.5||The p-value was derived from CMH general association test controlling for study center.|Cochran-Mantel-Haenszel||The difference between LS means derived from the Cochran-Mantel-Haenszel (CMH) model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Difficulty Falling Asleep: Week 7||1.50|0.68|0.9568
72451984|NCT01074294|144426478|SUPERIORITY||Risk Ratio (RR)|0.91||||0.6308|TWO_SIDED|95.0|0.63|1.31||The p-value was derived from CMH general association test controlling for study center.|Cochran-Mantel-Haenszel||The difference between LS means derived from the Cochran-Mantel-Haenszel (CMH) model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Difficulty Falling Asleep: Week 9||1.31|0.63|0.6308
72451985|NCT01074294|144426478|SUPERIORITY||Risk Ratio (RR)|0.92||||0.6698|TWO_SIDED|95.0|0.64|1.32||The p-value was derived from CMH general association test controlling for study center|Cochran-Mantel-Haenszel||The difference between LS means derived from the Cochran-Mantel-Haenszel (CMH) model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Difficulty Falling Asleep: Week 11||1.32|0.64|0.6698
72451986|NCT01074294|144426478|SUPERIORITY||Risk Ratio (RR)|0.76||||0.2012|TWO_SIDED|95.0|0.5|1.15||The p-value was derived from CMH general association test controlling for study center.|Cochran-Mantel-Haenszel||The difference between LS means derived from the Cochran-Mantel-Haenszel (CMH) model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Difficulty Staying Asleep: Week 7||1.15|0.50|0.2012
72499182|NCT00619957|144528709|SUPERIORITY_OR_OTHER||LS Mean Difference|-22.39|||<|0.0001|TWO_SIDED|95.0|-27.8|-16.98|||ANOVA|Fixed effects for treatment and pooled center.||A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.||-16.98|-27.80|<0.0001
72499183|NCT00619957|144528710|SUPERIORITY_OR_OTHER||LS Mean Difference|-28.15|||<|0.0001|TWO_SIDED|95.0|-39.84|-16.47|||ANOVA|Fixed effects for treatment and pooled center.||A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.||-16.47|-39.84|<0.0001
72451987|NCT01074294|144426478|SUPERIORITY||Risk Ratio (RR)|0.78||||0.2365|TWO_SIDED|95.0|0.52|1.16||The p-value was derived from CMH general association test controlling for study center.|Cochran-Mantel-Haenszel||The difference between LS means derived from the Cochran-Mantel-Haenszel (CMH) model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Difficulty Staying Asleep: Week 9||1.16|0.52|0.2365
72391465|NCT00291577|144290066|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|97.81||||||90.0|80.44|118.94|||||Ratio percent (%) (Test/Reference) of adjusted geometric means; values have been back-transformed from the log scale.|Total drug C1D2 vs C2D3||118.94|80.44|
72619914|NCT02539394|144770955|EQUIVALENCE|43 patient in each group need to achieved \>80% power to detect a 15 point differences in SWAL-QOL survey||||||0.483|||||||Wilcoxon (Mann-Whitney)|||The distribution of POD1 SWAL-QOL - Social is the same across the 2 arms||||0.483
72619915|NCT02539394|144770955|EQUIVALENCE|43 patient in each group need to achieved \>80% power to detect a 15 point differences in SWAL-QOL survey||||||0.07|||||||Wilcoxon (Mann-Whitney)|||The distribution of POD2 SWAL-QOL - Social is the same across the 2 arms||||0.070
72391466|NCT00291577|144290067|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|101.23||||||90.0|82.75|123.83|||||Ratio percent (%) (Test/Reference) of adjusted geometric means; values have been back-transformed from the log scale.|SU011248 C1D2 vs C2D3||123.83|82.75|
72391467|NCT00291577|144290067|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|81.72||||||90.0|62.4|107.04|||||Ratio percent (%) (Test/Reference) of adjusted geometric means; values have been back-transformed from the log scale.|SU012662 C1D2 vs C2D3||107.04|62.40|
72391468|NCT00291577|144290067|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|100.0||||||90.0|82.95|120.56|||||Ratio percent (%) (Test/Reference) of adjusted geometric means; values have been back-transformed from the log scale.|Total drug C1D2 vs C2D3||120.56|82.95|
72391469|NCT00291577|144290071|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|99.18||||||90.0|78.73|124.95|||||Ratio percent (%) (Test/Reference) of adjusted geometric means; values have been back-transformed from the log scale.|C1D1 vs C2D1||124.95|78.73|
72391470|NCT00291577|144290072|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|94.98||||||90.0|78.73|114.58|||||Ratio percent (%) (Test/Reference) of adjusted geometric means; values have been back-transformed from the log scale.|C1D1 vs C2D1||114.58|78.73|
72391471|NCT00291577|144290074|SUPERIORITY_OR_OTHER||rate (percent)|73.7||||||95.0|48.8|90.9|||||Two-sided Confidence Interval (CI) (%) from exact method based on F distribution.|Overall confirmed objective response rate (CR + PR)||90.9|48.8|
72391472|NCT00291577|144290075|SUPERIORITY_OR_OTHER||rate (percent)|89.5||||||95.0|66.9|98.7|||||Two-sided CI (%) from exact method based on F distribution.|Clinical Benefit Rate (CR + PR + SD \> = 24 weeks)||98.7|66.9|
72391473|NCT00291577|144290077|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|95.57||||||90.0|79.9|114.32|||||Ratio percent (%) (Test/Reference) of adjusted geometric means; values have been back-transformed from the log scale.|C1D1 vs C2D1||114.32|79.90|
72391474|NCT00291577|144290078|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|112.39||||||90.0|81.05|155.85|||||Ratio percent (%) (Test/Reference) of adjusted geometric means; values have been back-transformed from the log scale.|C1D1 vs C2D1||155.85|81.05|
72391475|NCT00291577|144290079|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|95.79||||||90.0|79.82|114.96|||||Ratio percent (%) (Test/Reference) of adjusted geometric means; values have been back-transformed from the log scale.|C1D1 vs C2D1||114.96|79.82|
72391476|NCT04967443|144290083|EQUIVALENCE|Bioequivalence will be demonstrated if the estimated 90% confidence interval for the ratios (Test/Reference) of adjusted geometric means for AUClast and Cmax fall entirely within (80%, 125%).|Ratio of adjusted geometric means|102.1|||||TWO_SIDED|90.0|96.14|108.43|||Mixed Models Analysis|||Test: Prazosin HCL 1x2 mg (Ascoli); Reference: Prazosin HCL 1x2 mg (Barceloneta)||108.43|96.14|
72391477|NCT04967443|144290083|EQUIVALENCE|Bioequivalence will be demonstrated if the estimated 90% confidence interval for the ratios (Test/Reference) of adjusted geometric means for AUClast and Cmax fall entirely within (80%, 125%).|Ratio of adjusted geometric means|104.87|||||TWO_SIDED|90.0|98.68|111.44|||Mixed Models Analysis|||Test: Prazosin HCL 2x1 mg (Ascoli); Reference: Prazosin HCL 1x2 mg (Barceloneta)||111.44|98.68|
72391478|NCT04967443|144290083|EQUIVALENCE|Bioequivalence will be demonstrated if the estimated 90% confidence interval for the ratios (Test/Reference) of adjusted geometric means for AUClast and Cmax fall entirely within (80%, 125%).|Ratio of adjusted geometric means|104.45|||||TWO_SIDED|90.0|99.58|109.55|||Mixed Models Analysis|||Test: Prazosin HCL 1x5 mg (Ascoli); Reference: Prazosin HCL 1x5 mg (Barceloneta)||109.55|99.58|
72391479|NCT04967443|144290084|EQUIVALENCE|Bioequivalence will be demonstrated if the estimated 90% confidence interval for the ratios (Test/Reference) of adjusted geometric means for AUClast and Cmax fall entirely within (80%, 125%).|Ratio of adjusted geometric means|113.96|||||TWO_SIDED|90.0|102.79|126.34|||Mixed Models Analysis|||Test: Prazosin HCL 1x2 mg (Ascoli); Reference: Prazosin HCL 1x2 mg (Barceloneta)||126.34|102.79|
72391480|NCT04967443|144290084|EQUIVALENCE|Bioequivalence will be demonstrated if the estimated 90% confidence interval for the ratios (Test/Reference) of adjusted geometric means for AUClast and Cmax fall entirely within (80%, 125%).|Ratio of adjusted geometric means|126.83|||||TWO_SIDED|90.0|114.32|140.7|||Mixed Models Analysis|||Test: Prazosin HCL 2x1 mg (Ascoli); Reference: Prazosin HCL 1x2 mg (Barceloneta)||140.70|114.32|
72391481|NCT04967443|144290084|EQUIVALENCE|Bioequivalence will be demonstrated if the estimated 90% confidence interval for the ratios (Test/Reference) of adjusted geometric means for AUClast and Cmax fall entirely within (80%, 125%).|Ratio of adjusted geometric means|118.07|||||TWO_SIDED|90.0|106.46|130.94|||Mixed Models Analysis|||Test: Prazosin HCL 1x5 mg (Ascoli); Reference: Prazosin HCL 1x5 mg (Barceloneta)||130.94|106.46|
72391482|NCT04967443|144290085|EQUIVALENCE|Bioequivalence will be demonstrated if the estimated 90% confidence interval for the ratios (Test/Reference) of adjusted geometric means for AUClast and Cmax fall entirely within (80%, 125%).|Ratio of adjusted geometric means|100.91|||||TWO_SIDED|90.0|94.92|107.27|||Mixed Models Analysis|||Test: Prazosin HCL 1x2 mg (Ascoli); Reference: Prazosin HCL 1x2 mg (Barceloneta)||107.27|94.92|
72391483|NCT04967443|144290085|EQUIVALENCE|Bioequivalence will be demonstrated if the estimated 90% confidence interval for the ratios (Test/Reference) of adjusted geometric means for AUClast and Cmax fall entirely within (80%, 125%).|Ratio of adjusted geometric means|102.08|||||TWO_SIDED|90.0|95.97|108.57|||Mixed Models Analysis|||Test: Prazosin HCL 2x1 mg (Ascoli); Reference: Prazosin HCL 1x2 mg (Barceloneta)||108.57|95.97|
72619916|NCT02539394|144770955|EQUIVALENCE|43 patient in each group need to achieved \>80% power to detect a 15 point differences in SWAL-QOL survey||||||0.2|||||||Wilcoxon (Mann-Whitney)|||The distribution of 4-6 weeks SWAL-QOL - Social is the same across the 2 arms||||0.200
72619917|NCT02539394|144770956|EQUIVALENCE|43 patient in each group need to achieved \>80% power to detect a 15 point differences in SWAL-QOL survey||||||0.148|||||||Wilcoxon (Mann-Whitney)|||The distribution of Pre-operative SWAL-QOL - Mental is the same across the 2 arms||||0.148
72619918|NCT02539394|144770956|EQUIVALENCE|43 patient in each group need to achieved \>80% power to detect a 15 point differences in SWAL-QOL survey||||||0.04|||||||Wilcoxon (Mann-Whitney)|||The distribution of POD1 SWAL-QOL - Mental is the same across the 2 arms||||0.040
72619919|NCT02539394|144770956|EQUIVALENCE|43 patient in each group need to achieved \>80% power to detect a 15 point differences in SWAL-QOL survey||||||0.042|||||||Wilcoxon (Mann-Whitney)|||The distribution of POD2 SWAL-QOL - Mental is the same across the 2 arms||||0.042
72619920|NCT02539394|144770956|EQUIVALENCE|43 patient in each group need to achieved \>80% power to detect a 15 point differences in SWAL-QOL survey||||||0.319|||||||Wilcoxon (Mann-Whitney)|||The distribution of 4-6 weeks SWAL-QOL - Mental is the same across the 2 arms||||0.319
72619921|NCT02539394|144770957|EQUIVALENCE|43 patient in each group need to achieved \>80% power to detect a 15 point differences in SWAL-QOL survey||||||0.161|||||||Wilcoxon (Mann-Whitney)|||The distribution of Pre-operative SWAL-QOL - Sleep is the same across the 2 arms||||0.161
72619922|NCT02539394|144770957|EQUIVALENCE|43 patient in each group need to achieved \>80% power to detect a 15 point differences in SWAL-QOL survey||||||0.763|||||||Wilcoxon (Mann-Whitney)|||The distribution of POD1 SWAL-QOL - Sleep is the same across the 2 arms||||0.763
72451988|NCT01074294|144426478|SUPERIORITY||Risk Ratio (RR)|0.65||||0.0312|TWO_SIDED|95.0|0.44|0.96||The p-value was derived from CMH general association test controlling for study center.|Cochran-Mantel-Haenszel||The difference between LS means derived from the Cochran-Mantel-Haenszel (CMH) model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Difficulty Staying Asleep: Week 11||0.96|0.44|0.0312
72451989|NCT01074294|144426478|SUPERIORITY||Risk Ratio (RR)|1.12||||0.6408|TWO_SIDED|95.0|0.69|1.81||The p-value was derived from CMH general association test controlling for study center.|Cochran-Mantel-Haenszel||The difference between LS means derived from the Cochran-Mantel-Haenszel (CMH) model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Waking Up Too Early: Week 7||1.81|0.69|0.6408
72619923|NCT02539394|144770957|EQUIVALENCE|43 patient in each group need to achieved \>80% power to detect a 15 point differences in SWAL-QOL survey||||||0.178|||||||Wilcoxon (Mann-Whitney)|||The distribution of POD2 SWAL-QOL - Sleep is the same across the 2 arms||||0.178
72619924|NCT02539394|144770957|EQUIVALENCE|43 patient in each group need to achieved \>80% power to detect a 15 point differences in SWAL-QOL survey||||||0.091|||||||Wilcoxon (Mann-Whitney)|||The distribution of 4-6 weeks SWAL-QOL - Sleep is the same across the 2 arms||||0.091
72619925|NCT02539394|144770958|EQUIVALENCE|43 patient in each group need to achieved \>80% power to detect a 15 point differences in SWAL-QOL survey||||||0.602|||||||Wilcoxon (Mann-Whitney)|||The distribution of Pre-operative SWAL-QOL - Fatigue is the same across the 2 arms||||0.602
72451990|NCT01074294|144426478|SUPERIORITY||Risk Ratio (RR)|1.24||||0.3467|TWO_SIDED|95.0|0.79|1.96||The p-value was derived from CMH general association test controlling for study center.|Cochran-Mantel-Haenszel||The difference between LS means derived from the Cochran-Mantel-Haenszel (CMH) model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Waking Up Too Early: Week 9||1.96|0.79|0.3467
72504806|NCT03114969|144540516|SUPERIORITY||Odds Ratio (OR)|2.284||||0.143|TWO_SIDED|95.0|0.757|6.895||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.|||6.895|0.757|0.143
72619926|NCT02539394|144770958|EQUIVALENCE|43 patient in each group need to achieved \>80% power to detect a 15 point differences in SWAL-QOL survey||||||0.302|||||||Wilcoxon (Mann-Whitney)|||The distribution of POD1 SWAL-QOL - Fatigue is the same across the 2 arms||||0.302
72619927|NCT02539394|144770958|EQUIVALENCE|43 patient in each group need to achieved \>80% power to detect a 15 point differences in SWAL-QOL survey||||||0.114|||||||Wilcoxon (Mann-Whitney)|||The distribution of POD2 SWAL-QOL - Fatigue is the same across the 2 arms||||0.114
72619928|NCT02539394|144770958|EQUIVALENCE|43 patient in each group need to achieved \>80% power to detect a 15 point differences in SWAL-QOL survey||||||0.005|||||||Wilcoxon (Mann-Whitney)|||The distribution of 4-6 weeks SWAL-QOL - Fatigue is the same across the 2 arms||||0.005
72619929|NCT02539394|144770959|EQUIVALENCE|Two-sided 95% confidence interval||||||0.933|||||||Wilcoxon (Mann-Whitney)|||The distribution of Pre-operative Eat-10 is the same across the 2 arms||||0.933
72619930|NCT02539394|144770959|EQUIVALENCE|Two-sided 95% confidence interval||||||0.95|||||||Wilcoxon (Mann-Whitney)|||The distribution of Pre-operative modified Eat-10 is the same across the 2 arms||||0.950
72619931|NCT02539394|144770959|EQUIVALENCE|Two-sided 95% confidence interval||||||0.059|||||||Wilcoxon (Mann-Whitney)|||The distribution of POD1 Eat-10 is the same across the 2 arms||||0.059
72619932|NCT02539394|144770959|EQUIVALENCE|Two-sided 95% confidence interval||||||0.042|||||||Wilcoxon (Mann-Whitney)|||The distribution of POD1 modified Eat-10 is the same across the 2 arms||||0.042
72619933|NCT02539394|144770959|EQUIVALENCE|Two-sided 95% confidence interval||||||0.032|||||||Wilcoxon (Mann-Whitney)|||The distribution of POD2 Eat-10 is the same across the 2 arms||||0.032
72619934|NCT02539394|144770959|EQUIVALENCE|Two-sided 95% confidence interval||||||0.014|||||||Wilcoxon (Mann-Whitney)|||The distribution of POD2 modified Eat-10 is the same across the 2 arms||||0.014
72619935|NCT02539394|144770959|EQUIVALENCE|Two-sided 95% confidence interval||||||0.03|||||||Wilcoxon (Mann-Whitney)|||The distribution of 4-6 weeks Eat-10 is the same across the 2 arms||||0.030
72619936|NCT02539394|144770959|EQUIVALENCE|Two-sided 95% confidence interval||||||0.039|||||||Wilcoxon (Mann-Whitney)|||The distribution of 4-6 weeks modified Eat-10 is the same across the 2 arms||||0.039
72619937|NCT02539394|144770960|EQUIVALENCE|Two-sided||||||0.121|||||||Chi-squared|||Proportion of Pre-operative Bazaz Liquid is the same between the 2 arms||||0.121
72619938|NCT02539394|144770960|EQUIVALENCE|Two-sided||||||0.006|||||||Chi-squared|||Proportion of POD1 Bazaz Liquid is the same between the 2 arms||||0.006
72451991|NCT01074294|144426478|SUPERIORITY||Risk Ratio (RR)|1.02||||0.9437|TWO_SIDED|95.0|0.65|1.59||The p-value was derived from CMH general association test controlling for study center.|Cochran-Mantel-Haenszel||The difference between LS means derived from the Cochran-Mantel-Haenszel (CMH) model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Waking Up Too Early: Week 11||1.59|0.65|0.9437
72451992|NCT01074294|144426479|SUPERIORITY||Mean Difference (Final Values)|0.41||||0.6357|TWO_SIDED|95.0|-1.3|2.12||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 6||2.12|-1.30|0.6357
72451993|NCT01074294|144426479|SUPERIORITY||Mean Difference (Final Values)|0.46||||0.6536|TWO_SIDED|95.0|-1.56|2.48||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 7||2.48|-1.56|0.6536
72451994|NCT01074294|144426479|SUPERIORITY||Mean Difference (Final Values)|-0.07||||0.9475|TWO_SIDED|95.0|-2.2|2.06||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 8||2.06|-2.20|0.9475
72451995|NCT01074294|144426479|SUPERIORITY||Mean Difference (Final Values)|0.99||||0.3973|TWO_SIDED|95.0|-1.31|3.29||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 9||3.29|-1.31|0.3973
72451996|NCT01074294|144426479|SUPERIORITY||Mean Difference (Final Values)|1.47||||0.2336|TWO_SIDED|95.0|-0.96|3.91||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 10||3.91|-0.96|0.2336
72451997|NCT01074294|144426479|SUPERIORITY||Mean Difference (Final Values)|0.95||||0.4553|TWO_SIDED|95.0|-1.55|3.44||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 11||3.44|-1.55|0.4553
72562123|NCT00996437|144655436|SUPERIORITY_OR_OTHER|||||||0.023||95.0||||P-value corresponds with the 12 week visit treatment comparison|Fisher Exact|At the each time point, treatment comparison analysis was performed using a Fisher Exact test.||||||.023
72562124|NCT00996437|144655437|SUPERIORITY_OR_OTHER|||||||0.27||95.0|||||Fisher Exact|At each time point, treatment comparison analysis was performed using a Fisher Exact Test.||||||0.27
72562125|NCT01573533|144655542|SUPERIORITY|||||||0.49|||||||ANOVA|||Baseline vs 12 months||||0.49
72451998|NCT01074294|144426480|SUPERIORITY||Mean Difference (Final Values)|0.29||||0.5647|TWO_SIDED|95.0|-0.7|1.27||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 6||1.27|-0.70|0.5647
72451999|NCT01074294|144426480|SUPERIORITY||Mean Difference (Final Values)|-0.02||||0.9739|TWO_SIDED|95.0|-1.15|1.12||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 7||1.12|-1.15|0.9739
72452000|NCT01074294|144426480|SUPERIORITY||Mean Difference (Final Values)|-0.15||||0.8077|TWO_SIDED|95.0|-1.4|1.09||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 8||1.09|-1.40|0.8077
72562126|NCT01573533|144655543|SUPERIORITY|||||||0.41|||||||ANOVA|||Baseline vs 12 months||||0.41
72562127|NCT01573533|144655544|SUPERIORITY|||||||0.06|||||||ANOVA|||Baseline vs 12 months||||0.06
72562128|NCT01186016|144655577|OTHER||||||<|0.01||||||A priori threshold for the P-Value was.05 or less.|ANOVA|||The scores on the Genetic Knowledge Test for both groups between baseline and the end of the educational sessions were analyzed with repeated measures ANOVA.||||<0.01
72562129|NCT01186016|144655578|OTHER|||||||0.44||||||The a priori threshold for statistical significance was a P-Value of .05 or less.|ANOVA|||Data for Self-Efficacy for Quitting/Resisting Smoking were analyzed with repeated measures ANOVA using three time points: baseline, end of the educational sessions, and end of the smoking cessation sessions.||||0.44
72562130|NCT01186016|144655579|OTHER|Nominal data were analyzed with Chi Square.||||||0.88||||||The a priori threshold P-Value for statistical significance was .05 or less.|Chi-squared|||||||.88
72562131|NCT01098539|144655580|NON_INFERIORITY_OR_EQUIVALENCE|The p-value was from a 1-sided t test to test whether the difference of LS means (albiglutide - sitagliptin) was less than or equal to the prespecified noninferiority margin of 0.4%.|Median Difference (Final Values)|-0.32|||<|0.0001|TWO_SIDED|95.0|-0.49|-0.15|||t-test, 1 sided|||||-0.15|-0.49|<0.0001
72562132|NCT00721955|144655596|SUPERIORITY|LS mean was used in the primary efficacy analysis|||||<|0.0001||||||p-values (adjusted) using Dunnett's t-test in main effects ANCOVA model|ANCOVA|||||||<0.0001
72452001|NCT01074294|144426480|SUPERIORITY||Mean Difference (Final Values)|0.34||||0.6119|TWO_SIDED|95.0|-0.98|1.65||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 9||1.65|-0.98|0.6119
72452002|NCT01074294|144426480|SUPERIORITY||Mean Difference (Final Values)|0.41||||0.5513|TWO_SIDED|95.0|-0.94|1.76||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 10||1.76|-0.94|0.5513
72452003|NCT01074294|144426480|SUPERIORITY||Mean Difference (Final Values)|0.57||||0.4185|TWO_SIDED|95.0|-0.81|1.95||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 11||1.95|-0.81|0.4185
72452004|NCT01074294|144426481|SUPERIORITY||Mean Difference (Final Values)|0.15||||0.7556|TWO_SIDED|95.0|-0.8|1.09||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 6||1.09|-0.80|0.7556
72452005|NCT01074294|144426481|SUPERIORITY||Mean Difference (Final Values)|0.5||||0.371|TWO_SIDED|95.0|-0.6|1.59||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 7||1.59|-0.60|0.3710
72452006|NCT01074294|144426481|SUPERIORITY||Mean Difference (Final Values)|0.11||||0.8464|TWO_SIDED|95.0|-0.99|1.21||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 8||1.21|-0.99|0.8464
72452007|NCT01074294|144426481|SUPERIORITY||Mean Difference (Final Values)|0.69||||0.2664|TWO_SIDED|95.0|-0.53|1.91||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 9||1.91|-0.53|0.2664
72452008|NCT01074294|144426481|SUPERIORITY||Mean Difference (Final Values)|1.13||||0.0876|TWO_SIDED|95.0|-0.17|2.42||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 10||2.42|-0.17|0.0876
72452009|NCT01074294|144426481|SUPERIORITY||Mean Difference (Final Values)|0.44||||0.5119|TWO_SIDED|95.0|-0.89|1.77||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 11||1.77|-0.89|0.5119
72452010|NCT01074294|144426482|SUPERIORITY||Mean Difference (Final Values)|0.07||||0.8986|TWO_SIDED|95.0|-1.03|1.18||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 6||1.18|-1.03|0.8986
72452011|NCT01074294|144426482|SUPERIORITY||Mean Difference (Final Values)|0.26||||0.685|TWO_SIDED|95.0|-1.02|1.55||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 7||1.55|-1.02|0.6850
72452012|NCT01074294|144426482|SUPERIORITY||Mean Difference (Final Values)|-0.26||||0.7108|TWO_SIDED|95.0|-1.61|1.1||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 8||1.10|-1.61|0.7108
72452013|NCT01074294|144426482|SUPERIORITY||Mean Difference (Final Values)|-0.07||||0.9236|TWO_SIDED|95.0|-1.5|1.36||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 9||1.36|-1.50|0.9236
72562133|NCT00721955|144655596|SUPERIORITY|p-values (adjusted) using Dunnett's t-test in main effects ANCOVA model|||||<|0.0001||||||p-values (adjusted) using Dunnett's t-test in main effects ANCOVA model|ANCOVA|||||||<0.0001
72562134|NCT00721955|144655597|SUPERIORITY|LS mean was used in the primary efficacy analysis|||||<|0.0001||||||p-values (adjusted) using Dunnett's t-test in main effects ANCOVA model|ANCOVA|||||||<0.0001
72562135|NCT00721955|144655597|SUPERIORITY||||||<|0.0001||||||-values (adjusted) using Dunnett's t-test in main effects ANCOVA model|ANCOVA|||||||<0.0001
72562136|NCT01589601|144655611|SUPERIORITY||Mean Difference (Net)|4.8719||||0.1641|TWO_SIDED|95.0|-2.0289|11.7728|||Mixed Models Analysis|Baseline||||11.7728|-2.0289|0.1641
72562137|NCT01589601|144655611|SUPERIORITY|6 Months|Mean Difference (Net)|9.4938||||0.0299|TWO_SIDED|95.0|0.9406|18.047|||Mixed Models Analysis|||||18.0470|0.9406|0.0299
72562138|NCT01589601|144655612|SUPERIORITY||Mean Difference (Net)|2.7157||||0.5531|TWO_SIDED|95.0|-6.3054|11.7368|||Mixed Models Analysis|Baseline||||11.7368|-6.3054|0.5531
72391484|NCT04967443|144290085|EQUIVALENCE|Bioequivalence will be demonstrated if the estimated 90% confidence interval for the ratios (Test/Reference) of adjusted geometric means for AUClast and Cmax fall entirely within (80%, 125%).|Ratio of adjusted geometric means|104.04|||||TWO_SIDED|90.0|99.09|109.23|||Mixed Models Analysis|||Test: Prazosin HCL 1x5 mg (Ascoli); Reference: Prazosin HCL 1x5 mg (Barceloneta)||109.23|99.09|
72391485|NCT03473977|144290121|OTHER|||||||0.0001|||||||Fisher Exact|||||||0.0001
72391486|NCT03473977|144290122|OTHER|||||||0.75|||||||Kruskal-Wallis|||||||0.75
72391487|NCT03473977|144290123|OTHER|||||||0.006|||||||Kruskal-Wallis|||||||0.006
72391488|NCT03473977|144290124|OTHER|||||||0.004|||||||Kruskal-Wallis|||||||0.004
72391489|NCT03473977|144290125|OTHER|||||||0.0058|||||||t-test, 2 sided|||||||0.0058
72391490|NCT03473977|144290126|OTHER|||||||0.014|||||||Kruskal-Wallis|||||||0.014
72391491|NCT03473977|144290127|OTHER|||||||0.78|||||||Kruskal-Wallis|||Pain Score Comparison||||0.78
72391492|NCT03473977|144290127|OTHER|||||||0.34|||||||Kruskal-Wallis|||Non-pain score comparison||||0.34
72391493|NCT03473977|144290127|OTHER|||||||0.66|||||||Kruskal-Wallis|||Satisfaction score comparison||||0.66
72391494|NCT04502693|144290128|OTHER|Effectiveness of rMenB+OMV NZ vaccine is demonstrated if the LL of the 2-sided 97.5% CI for Vaccine Effectiveness (VE) against the selected strain panel between the MenB\_0\_2\_6 and the ACWY groups is above 65%. VE is defined as 1- Risk Ratio (RR) = (1- percentage of samples without bactericidal serum activity at 1:4 dilution in MenB group / percentage of samples without bactericidal serum activity at 1:4 dilution in the ACWY group) x100 percentage.|VE (Vaccine Effectiveness)|83.2|||||TWO_SIDED|97.5|81.9|84.4||||||To demonstrate the effectiveness of the rMenB+OMV NZ vaccine against a randomly selected panel of endemic US N. meningitidis serogroup B invasive disease strains as measured by bactericidal activity using enc-hSBA at 1 month after the 3-dose (0,2,6-months) schedule in MenB\_0\_2\_6 group when compared to 1 month after the MenACWY dose in the ACWY group.||84.4|81.9|
72391495|NCT04502693|144290128|OTHER|"Effectiveness of rMenB+OMV NZ vaccine is demonstrated if the LL of the 2-sided 97.5% CI for VE against the selected strain panel between the MenB\_0\_ 6 and the ACWY groups is above 65%.~VE is defined as 1- RR = (1- percentage of samples without bactericidal serum activity at 1:4 dilution in MenB group / percentage of samples without bactericidal serum activity at 1:4 dilution in the ACWY group) x100 percentage."|VE|81.8|||||TWO_SIDED|97.5|80.4|83.1||||||To demonstrate the effectiveness of the rMenB+OMV NZ vaccine against a randomly selected panel of endemic US N. meningitidis serogroup B invasive disease strains as measured by bactericidal activity using enc-hSBA at 1 month after the 2-dose (0,6-M) schedule in MenB\_0\_6 group when compared to 1 month after the MenACWY dose in the ACWY group.||83.1|80.4|
72391496|NCT04502693|144290129|OTHER|Effectiveness of rMenB+OMV NZ vaccine is demonstrated if the LL of the 2-sided 97.5% CI for VE against the selected strain panel between the MenB\_0\_2\_6 and the ACWY groups is above 65%. VE is defined as 1- RR = (1- percentage of samples without bactericidal serum activity at 1:4 dilution in MenB group / percentage of samples without bactericidal serum activity at 1:4 dilution in the ACWY group) x100 percentage.|VE|78.7|||||TWO_SIDED|97.5|77.2|80.1||||||To demonstrate the effectiveness of the rMenB+OMV NZ vaccine against a randomly selected panel of endemic US N. meningitidis serogroup B invasive disease strains as measured by bactericidal activity using enc-hSBA at 1 month after the 2-dose (0,2-M) schedule in MenB\_0\_2\_6 group when compared to 1 month after the MenACWY dose in the ACWY group.||80.1|77.2|
72391497|NCT04502693|144290132|EQUIVALENCE|Lot-to-lot consistency is claimed if the 2-sided 95% CIs for the ratio of hSBA GMTs of antibodies against each of the serogroups A, C, W and Y are within the \[0.5;2.0\] equivalence interval for each pair of lots.|GMT ratio|0.96|||||TWO_SIDED|95.0|0.84|1.1||||||To demonstrate lot-to-lot consistency of the immune responses of ABCWY-1 and ABCWY-2 lots of the MenACWY component of the MenABCWY vaccine, as measured by hSBA GMTs directed against serogroup A at 1 month after last vaccination (Day 211).||1.10|0.84|
72391498|NCT04502693|144290132|EQUIVALENCE|Lot-to-lot consistency is claimed if the 2-sided 95% CIs for the ratio of hSBA GMTs of antibodies against each of the serogroups A, C, W and Y is within the \[0.5;2.0\] equivalence interval for each pair of lots.|GMT ratio|0.86|||||TWO_SIDED|95.0|0.75|0.98||||||To demonstrate lot-to-lot consistency of the immune responses of ABCWY-1 and ABCWY-3 lots of the MenACWY component of the MenABCWY vaccine, as measured by hSBA GMTs directed against serogroup A at 1 month after last vaccination (Day 211).||0.98|0.75|
72391499|NCT04502693|144290132|EQUIVALENCE|Lot-to-lot consistency is claimed if the 2-sided 95% CIs for the ratio of hSBA GMTs of antibodies against each of the serogroups A, C, W and Y is within the \[0.5;2.0\] equivalence interval for each pair of lots.|GMT ratio|0.9|||||TWO_SIDED|95.0|0.78|1.02||||||To demonstrate lot-to-lot consistency of the immune responses of ABCWY-2 and ABCWY-3 lots of the MenACWY component of the MenABCWY vaccine, as measured by hSBA GMTs directed against serogroup A at 1 month after last vaccination (Day 211).||1.02|0.78|
72391500|NCT04502693|144290132|EQUIVALENCE|Lot-to-lot consistency is claimed if the 2-sided 95% CIs for the ratio of hSBA GMTs of antibodies against each of the serogroups A, C, W and Y are within the \[0.5;2.0\] equivalence interval for each pair of lots.|GMT ratio|0.92|||||TWO_SIDED|95.0|0.76|1.11||||||To demonstrate lot-to-lot consistency of the immune responses of ABCWY-1 and ABCWY-2 lots of the MenACWY component of the MenABCWY vaccine, as measured by hSBA GMTs directed against serogroup C at 1 month after last vaccination (Day 211).||1.11|0.76|
72391501|NCT04502693|144290132|EQUIVALENCE|Lot-to-lot consistency is claimed if the 2-sided 95% CIs for the ratio of hSBA GMTs of antibodies against each of the serogroups A, C, W and Y is within the \[0.5;2.0\] equivalence interval for each pair of lots.|GMT ratio|1.17|||||TWO_SIDED|95.0|0.97|1.41||||||To demonstrate lot-to-lot consistency of the immune responses of ABCWY-1 and ABCWY-3 lots of the MenACWY component of the MenABCWY vaccine, as measured by hSBA GMTs directed against serogroup C at 1 month after last vaccination (Day 211).||1.41|0.97|
72562139|NCT01589601|144655612|SUPERIORITY||Mean Difference (Net)|11.773||||0.035|TWO_SIDED|95.0|0.8409|22.7052|||Mixed Models Analysis|6 Months||||22.7052|0.8409|0.0350
72562140|NCT01589601|144655613|SUPERIORITY|HADS Anxiety 2 weeks|Mean Difference (Net)|-1.2436||||0.1592|TWO_SIDED|95.0|-2.9817|0.4945|||Mixed Models Analysis|||||0.4945|-2.9817|0.1592
72562141|NCT01589601|144655613|SUPERIORITY|HADS Anxiety 3 months|Mean Difference (Net)|-0.7946||||0.3657|TWO_SIDED|95.0|-2.5285|0.9393|||Mixed Models Analysis|||||0.9393|-2.5285|0.3657
72562142|NCT01589601|144655613|SUPERIORITY|HADS Anxiety 6 months|Mean Difference (Net)|-1.8269||||0.048|TWO_SIDED|95.0|-3.6375|-0.0164|||Mixed Models Analysis|||||-0.0164|-3.6375|0.0480
72452014|NCT01074294|144426482|SUPERIORITY||Mean Difference (Final Values)|0.13||||0.8576|TWO_SIDED|95.0|-1.35|1.61||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 10||1.61|-1.35|0.8576
72452015|NCT01074294|144426482|SUPERIORITY||Mean Difference (Final Values)|-0.15||||0.8483|TWO_SIDED|95.0|-1.67|1.37||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 11||1.37|-1.67|0.8483
72452016|NCT01074294|144426483|SUPERIORITY||Mean Difference (Final Values)|-0.04||||0.6976|TWO_SIDED|95.0|-0.22|0.15||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 6||0.15|-0.22|0.6976
72452017|NCT01074294|144426483|SUPERIORITY||Mean Difference (Final Values)|-0.04||||0.6986|TWO_SIDED|95.0|-0.25|0.17||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 7||0.17|-0.25|0.6986
72452018|NCT01074294|144426483|SUPERIORITY||Mean Difference (Final Values)|-0.06||||0.6507|TWO_SIDED|95.0|-0.3|0.19||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 8||0.19|-0.30|0.6507
72562143|NCT01589601|144655613|SUPERIORITY|HADS Depression at 2 weeks|Mean Difference (Net)|-0.9097||||0.2372|TWO_SIDED|95.0|-2.4253|0.6058|||Mixed Models Analysis|||||0.6058|-2.4253|0.2372
72452019|NCT01074294|144426483|SUPERIORITY||Mean Difference (Final Values)|-0.06||||0.655|TWO_SIDED|95.0|-0.32|0.2||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 9||0.20|-0.32|0.6550
72452020|NCT01074294|144426483|SUPERIORITY||Mean Difference (Final Values)|0.11||||0.3959|TWO_SIDED|95.0|-0.15|0.38||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 10||0.38|-0.15|0.3959
72452021|NCT01074294|144426483|SUPERIORITY||Mean Difference (Final Values)|0.06||||0.6763|TWO_SIDED|95.0|-0.23|0.35||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 11||0.35|-0.23|0.6763
72452022|NCT01074294|144426484|SUPERIORITY||Mean Difference (Final Values)|0.27||||0.4089|TWO_SIDED|95.0|-0.37|0.91||The p-value was derived from ANCOVA model, with treatment and study center as main effects and week 5 value as covariate, is used for change from week 5 comparisons.|ANCOVA||The difference between LS means derived from the ANCOVA model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|||0.91|-0.37|0.4089
72452023|NCT01074294|144426485|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.3||||0.2331|TWO_SIDED|95.0|-0.8|0.2||The p-value was derived from ANCOVA model, with treatment and study center as main effects and week 5 value as covariate, is used for change from week 5 comparisons.|ANCOVA||Week 11 data is included here. The planned sample size of 225 participants (150 in brexipiprazole arm and 75 in the placebo arm) yielded at least 80% power to detect effects at a 2-tailed significance level of 0.05 using a two-sided z-test.|||0.20|-0.80|0.2331
72452024|NCT01074294|144426486|SUPERIORITY||Mean Difference (Final Values)|-0.01||||0.067|TWO_SIDED|95.0|-0.01|0.0||The p-value was derived from ANCOVA model, with treatment and study center as main effects and week 5 value as covariate, is used for change from week 5 comparisons.|ANCOVA||The difference between LS means derived from the ANCOVA model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|||0.00|-0.01|0.0670
72452025|NCT01074294|144426487|SUPERIORITY||Mean Difference (Final Values)|-14.3||||0.0849|TWO_SIDED|95.0|-30.5|1.98||The p-value was derived from ANCOVA model, with treatment and study center as main effects and week 5 value as covariate, is used for change from week 5 comparisons.|ANCOVA||The difference between LS means derived from the ANCOVA model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|||1.98|-30.5|0.0849
72562144|NCT01589601|144655613|SUPERIORITY|HADS Depression 3 months|Mean Difference (Net)|-0.6592||||0.4237|TWO_SIDED|95.0|-2.2862|0.9678|||Mixed Models Analysis|||||0.9678|-2.2862|0.4237
72562145|NCT01589601|144655613|SUPERIORITY|HADS Depression at 6 months|Mean Difference (Net)|-1.9379||||0.0202|TWO_SIDED|95.0|-3.5672|-0.3085|||Mixed Models Analysis|||||-0.3085|-3.5672|0.0202
72562146|NCT01589601|144655615|SUPERIORITY|FACIT-Sp at 2 weeks|Mean Difference (Net)|0.9413||||0.5857|TWO_SIDED|95.0|-2.4666|4.3493|||Mixed Models Analysis|||||4.3493|-2.4666|0.5857
72562147|NCT01589601|144655615|SUPERIORITY|FACIT-Sp at 3 months|Mean Difference (Net)|1.1174||||0.5655|TWO_SIDED|95.0|-2.7246|4.9594|||Mixed Models Analysis|||||4.9594|-2.7246|0.5655
72562148|NCT01589601|144655615|SUPERIORITY|FACIT-Sp at 6 months|Mean Difference (Net)|3.9809||||0.0271|TWO_SIDED|95.0|0.4581|7.5036|||Mixed Models Analysis|||||7.5036|0.4581|0.0271
72562149|NCT01589601|144655617|SUPERIORITY|All-cause readmissions, Poisson regression with log link and Pearson scale||||||0.56|||||||Poisson regression|||||||0.56
72562150|NCT01589601|144655617|SUPERIORITY|Cardiovascular readmissions, Poisson regression with log link and Pearson scale||||||0.8|||||||Poisson regression|||||||0.80
72391502|NCT04502693|144290132|EQUIVALENCE|Lot-to-lot consistency is claimed if the 2-sided 95% CIs for the ratio of hSBA GMTs of antibodies against each of the serogroups A, C, W and Y is within the \[0.5;2.0\] equivalence interval for each pair of lots.|GMT ratio|1.27|||||TWO_SIDED|95.0|1.05|1.54||||||To demonstrate lot-to-lot consistency of the immune responses of ABCWY-2 and ABCWY-3 lots of the MenACWY component of the MenABCWY vaccine, as measured by hSBA GMTs directed against serogroup C at 1 month after last vaccination (Day 211).||1.54|1.05|
72452026|NCT01074294|144426488|SUPERIORITY||Mean Difference (Final Values)|-0.46||||0.7663|TWO_SIDED|95.0|-3.52|2.6||The p-value was derived from ANCOVA model, with treatment and study center as main effects and week 5 value as covariate, is used for change from week 5 comparisons.|ANCOVA||The difference between LS means derived from the ANCOVA model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|||2.60|-3.52|0.7663
72452027|NCT01074294|144426489|SUPERIORITY||Mean Difference (Final Values)|17.51||||0.0298|TWO_SIDED|95.0|1.73|33.29||The p-value was derived from ANCOVA model, with treatment and study center as main effects and week 5 value as covariate, is used for change from week 5 comparisons.|ANCOVA||The difference between LS means derived from the ANCOVA model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|||33.29|1.73|0.0298
72452028|NCT01074294|144426490|SUPERIORITY||Mean Difference (Final Values)|-0.02||||0.2563|TWO_SIDED|95.0|-0.05|0.01||The p-value was derived from ANCOVA model, with treatment and study center as main effects and week 5 value as covariate, is used for change from week 5 comparisons.|ANCOVA||The difference between LS means derived from the ANCOVA model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|||0.01|-0.05|0.2563
72452029|NCT01074294|144426491|SUPERIORITY||Mean Difference (Final Values)|-5.67||||0.6644|TWO_SIDED|95.0|-31.4|20.06||The p-value was derived from ANCOVA model, with treatment and study center as main effects and week 5 value as covariate, is used for change from week 5 comparisons.|ANCOVA||The difference between LS means derived from the ANCOVA model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|||20.06|-31.4|0.6644
72452030|NCT01074294|144426492|SUPERIORITY||Mean Difference (Final Values)|-0.05||||0.8418|TWO_SIDED|95.0|-0.56|0.45||The p-value was derived from ANCOVA model, with treatment and study center as main effects and week 5 value as covariate, is used for change from week 5 comparisons.|ANCOVA||The difference between LS means derived from the ANCOVA model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|||0.45|-0.56|0.8418
72452031|NCT01074294|144426493|SUPERIORITY||Mean Difference (Final Values)|-0.26||||0.2513|TWO_SIDED|95.0|-0.69|0.18||The p-value was derived from ANCOVA model, with treatment and study center as main effects and week 5 value as covariate, is used for change from week 5 comparisons.|ANCOVA||The difference between LS means derived from the ANCOVA model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|||0.18|-0.69|0.2513
72452032|NCT01074294|144426494|SUPERIORITY||Mean Difference (Final Values)|0.11||||0.7037|TWO_SIDED|95.0|-0.48|0.71||The p-value was derived from ANCOVA model, with treatment and study center as main effects and week 5 value as covariate, is used for change from week 5 comparisons.|ANCOVA||The difference between LS means derived from the ANCOVA model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|||0.71|-0.48|0.7037
72452033|NCT01074294|144426495|SUPERIORITY||Mean Difference (Final Values)|0.03||||0.7572|TWO_SIDED|95.0|-0.17|0.23||The p-value was derived from CMH row mean scores differ test controlling for study center.|Cochran-Mantel-Haenszel||The difference between LS means derived from the CMH model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Week 6||0.23|-0.17|0.7572
72452034|NCT01074294|144426495|SUPERIORITY||Mean Difference (Final Values)|-0.06||||0.6132|TWO_SIDED|95.0|-0.28|0.17||The p-value was derived from CMH row mean scores differ test controlling for study center.|Cochran-Mantel-Haenszel||The difference between LS means derived from the CMH model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Week 7||0.17|-0.28|0.6132
72452035|NCT01074294|144426495|SUPERIORITY||Mean Difference (Final Values)|0.01||||0.9312|TWO_SIDED|95.0|-0.25|0.27||The p-value was derived from CMH row mean scores differ test controlling for study center.|Cochran-Mantel-Haenszel||The difference between LS means derived from the CMH model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Week 8||0.27|-0.25|0.9312
72452036|NCT01074294|144426495|SUPERIORITY||Mean Difference (Final Values)|-0.03||||0.8073|TWO_SIDED|95.0|-0.3|0.24||The p-value was derived from CMH row mean scores differ test controlling for study center.|Cochran-Mantel-Haenszel||The difference between LS means derived from the CMH model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Week 9||0.24|-0.30|0.8073
72452037|NCT01074294|144426495|SUPERIORITY||Mean Difference (Final Values)|0.01||||0.9168|TWO_SIDED|95.0|-0.26|0.29||The p-value was derived from CMH row mean scores differ test controlling for study center.|Cochran-Mantel-Haenszel||The difference between LS means derived from the CMH model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Week 10||0.29|-0.26|0.9168
72452038|NCT01074294|144426495|SUPERIORITY||Mean Difference (Final Values)|-0.05||||0.7432|TWO_SIDED|95.0|-0.34|0.25||The p-value was derived from CMH row mean scores differ test controlling for study center.|Cochran-Mantel-Haenszel||The difference between LS means derived from the CMH model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Week 11||0.25|-0.34|0.7432
72452039|NCT01074294|144426496|SUPERIORITY||Risk Ratio (RR)|1.2||||0.6014|TWO_SIDED|95.0|0.6|2.42||The p-value was derived from CMH general association test controlling for study center.|Cochran-Mantel-Haenszel||The difference between LS means derived from the CMH model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Week 6||2.42|0.60|0.6014
72562151|NCT01589601|144655617|SUPERIORITY|Heart failure readmissions, Poisson regression with log link and Pearson scale||||||0.92|||||||Poisson regression|||||||0.92
72562152|NCT01589601|144655617|SUPERIORITY|Non-cardiovascular readmissions, Poisson regression with log link and Pearson scale||||||0.12|||||||Poisson regression|||||||0.12
72619939|NCT02539394|144770960|EQUIVALENCE|Two-sided||||||0.329|||||||Chi-squared|||Proportion of POD2 Bazaz Liquid is the same between the 2 arms||||0.329
72619940|NCT02539394|144770960|EQUIVALENCE|Two-sided||||||0.687|||||||Chi-squared|||Proportion of 4-6 weeks Bazaz Liquid is the same between the 2 arms||||0.687
72619941|NCT02539394|144770961|EQUIVALENCE|Two-sided||||||0.066|||||||Chi-squared|||Proportion of Pre-operative Bazaz Solid is the same between the 2 arms||||0.066
72452040|NCT01074294|144426496|SUPERIORITY||Risk Ratio (RR)|1.02||||0.9225|TWO_SIDED|95.0|0.64|1.63||The p-value was derived from CMH general association test controlling for study center.|Cochran-Mantel-Haenszel||The difference between LS means derived from the CMH model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Week 7||1.63|0.64|0.9225
72452041|NCT01074294|144426496|SUPERIORITY||Risk Ratio (RR)|0.86||||0.4803|TWO_SIDED|95.0|0.58|1.3||The p-value was derived from CMH general association test controlling for study center.|Cochran-Mantel-Haenszel||The difference between LS means derived from the CMH model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Week 8||1.30|0.58|0.4803
72452042|NCT01074294|144426496|SUPERIORITY||Risk Ratio (RR)|0.91||||0.5876|TWO_SIDED|95.0|0.65|1.27||The p-value was derived from CMH general association test controlling for study center.|Cochran-Mantel-Haenszel||The difference between LS means derived from the CMH model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Week 9||1.27|0.65|0.5876
72452043|NCT01074294|144426496|SUPERIORITY||Risk Ratio (RR)|0.87||||0.3727|TWO_SIDED|95.0|0.64|1.18||The p-value was derived from CMH general association test controlling for study center.|Cochran-Mantel-Haenszel||The difference between LS means derived from the CMH model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Week 10||1.18|0.64|0.3727
72452044|NCT01074294|144426496|SUPERIORITY||Risk Ratio (RR)|0.93||||0.6265|TWO_SIDED|95.0|0.71|1.23||The p-value was derived from CMH general association test controlling for study center.|Cochran-Mantel-Haenszel||The difference between LS means derived from the CMH model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Week 11||1.23|0.71|0.6265
72452045|NCT01074294|144426497|SUPERIORITY||Risk Ratio (RR)|1.1||||0.8586|TWO_SIDED|95.0|0.4|3.03||The p-value was derived from CMH general association test controlling for study center.|Cochran-Mantel-Haenszel||The difference between LS means derived from the CMH model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Week 6||3.03|0.40|0.8586
72452046|NCT01074294|144426497|SUPERIORITY||Risk Ratio (RR)|0.95||||0.8984|TWO_SIDED|95.0|0.46|1.99||The p-value was derived from CMH general association test controlling for study center.|Cochran-Mantel-Haenszel||The difference between LS means derived from the CMH model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Week 7||1.99|0.46|0.8984
72452047|NCT01074294|144426497|SUPERIORITY||Risk Ratio (RR)|0.99||||0.9778|TWO_SIDED|95.0|0.57|1.74||The p-value was derived from CMH general association test controlling for study center.|Cochran-Mantel-Haenszel||The difference between LS means derived from the CMH model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Week 8||1.74|0.57|0.9778
72452048|NCT01074294|144426497|SUPERIORITY||Risk Ratio (RR)|0.92||||0.7315|TWO_SIDED|95.0|0.56|1.5||The p-value was derived from CMH general association test controlling for study center.|Cochran-Mantel-Haenszel||The difference between LS means derived from the CMH model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Week 9||1.50|0.56|0.7315
72452049|NCT01074294|144426497|SUPERIORITY||Risk Ratio (RR)|0.9||||0.6518|TWO_SIDED|95.0|0.57|1.42||The p-value was derived from CMH general association test controlling for study center.|Cochran-Mantel-Haenszel||The difference between LS means derived from the CMH model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Week 10||1.42|0.57|0.6518
72452050|NCT01074294|144426497|SUPERIORITY||Risk Ratio (RR)|0.82||||0.3472|TWO_SIDED|95.0|0.55|1.23||The p-value was derived from CMH general association test controlling for study center.|Cochran-Mantel-Haenszel||The difference between LS means derived from the CMH model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Week 11||1.23|0.55|0.3472
72452051|NCT01074294|144426498|SUPERIORITY||Risk Ratio (RR)|0.98||||0.9577|TWO_SIDED|95.0|0.44|2.16||The p-value was derived from CMH general association test controlling for study center.|Cochran-Mantel-Haenszel||The difference between LS means derived from the CMH model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Week 6||2.16|0.44|0.9577
72452052|NCT01074294|144426498|SUPERIORITY||Risk Ratio (RR)|1.19||||0.5864|TWO_SIDED|95.0|0.63|2.27||The p-value was derived from CMH general association test controlling for study center.|Cochran-Mantel-Haenszel||The difference between LS means derived from the CMH model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Week 7||2.27|0.63|0.5864
72452053|NCT01074294|144426498|SUPERIORITY||Risk Ratio (RR)|0.96||||0.8723|TWO_SIDED|95.0|0.57|1.6||The p-value was derived from CMH general association test controlling for study center.|Cochran-Mantel-Haenszel||The difference between LS means derived from the CMH model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Week 8||1.60|0.57|0.8723
72452054|NCT01074294|144426498|SUPERIORITY||Risk Ratio (RR)|1.0||||0.9872|TWO_SIDED|95.0|0.65|1.52||The p-value was derived from CMH general association test controlling for study center.|Cochran-Mantel-Haenszel||The difference between LS means derived from the CMH model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Week 9||1.52|0.65|0.9872
72452055|NCT01074294|144426498|SUPERIORITY||Risk Ratio (RR)|0.8||||0.3171|TWO_SIDED|95.0|0.52|1.23||The p-value was derived from CMH general association test controlling for study center.|Cochran-Mantel-Haenszel||The difference between LS means derived from the CMH model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Week 10||1.23|0.52|0.3171
72452056|NCT01074294|144426498|SUPERIORITY||Risk Ratio (RR)|0.87||||0.4782|TWO_SIDED|95.0|0.6|1.27||The p-value was derived from CMH general association test controlling for study center.|Cochran-Mantel-Haenszel||The difference between LS means derived from the CMH model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Week 11||1.27|0.60|0.4782
72619942|NCT02539394|144770961|EQUIVALENCE|Two-sided||||||0.252|||||||Chi-squared|||Proportion of POD1 Bazaz Solid is the same between the 2 arms||||0.252
72452057|NCT01074294|144426499|SUPERIORITY||Risk Ratio (RR)|1.19||||0.7232|TWO_SIDED|95.0|0.45|3.19||The p-value was derived from CMH general association test controlling for study center.|Cochran-Mantel-Haenszel||The difference between LS means derived from the CMH model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Week 6||3.19|0.45|0.7232
72619943|NCT02539394|144770961|EQUIVALENCE|Two-sided||||||0.1|||||||Chi-squared|||Proportion of POD2 Bazaz Solid is the same between the 2 arms||||0.100
72391503|NCT04502693|144290132|EQUIVALENCE|Lot-to-lot consistency is claimed if the 2-sided 95% CIs for the ratio of hSBA GMTs of antibodies against each of the serogroups A, C, W and Y are within the \[0.5;2.0\] equivalence interval for each pair of lots.|GMT ratio|0.89|||||TWO_SIDED|95.0|0.77|1.02||||||To demonstrate lot-to-lot consistency of the immune responses of ABCWY-1 and ABCWY-2 lots of the MenACWY component of the MenABCWY vaccine, as measured by hSBA GMTs directed against serogroup W at 1 month after last vaccination (Day 211).||1.02|0.77|
72391504|NCT04502693|144290132|EQUIVALENCE|Lot-to-lot consistency is claimed if the 2-sided 95% CIs for the ratio of hSBA GMTs of antibodies against each of the serogroups A, C, W and Y is within the \[0.5;2.0\] equivalence interval for each pair of lots.|GMT ratio|0.88|||||TWO_SIDED|95.0|0.77|1.02||||||To demonstrate lot-to-lot consistency of the immune responses of ABCWY-1 and ABCWY-3 lots of the MenACWY component of the MenABCWY vaccine, as measured by hSBA GMTs directed against serogroup W at 1 month after last vaccination (Day 211).||1.02|0.77|
72391505|NCT04502693|144290132|EQUIVALENCE|Lot-to-lot consistency is claimed if the 2-sided 95% CIs for the ratio of hSBA GMTs of antibodies against each of the serogroups A, C, W and Y is within the \[0.5;2.0\] equivalence interval for each pair of lots.|GMT ratio|0.99|||||TWO_SIDED|95.0|0.86|1.14||||||To demonstrate lot-to-lot consistency of the immune responses of ABCWY-2 and ABCWY-3 lots of the MenACWY component of the MenABCWY vaccine, as measured by hSBA GMTs directed against serogroup W at 1 month after last vaccination (Day 211).||1.14|0.86|
72391506|NCT04502693|144290132|EQUIVALENCE|Lot-to-lot consistency is claimed if the 2-sided 95% CIs for the ratio of hSBA GMTs of antibodies against each of the serogroups A, C, W and Y are within the \[0.5;2.0\] equivalence interval for each pair of lots.|GMT ratio|0.86|||||TWO_SIDED|95.0|0.73|1.01||||||To demonstrate lot-to-lot consistency of the immune responses of ABCWY-1 and ABCWY-2 lots of the MenACWY component of the MenABCWY vaccine, as measured by hSBA GMTs directed against serogroup Y at 1 month after last vaccination (Day 211).||1.01|0.73|
72391507|NCT04502693|144290132|EQUIVALENCE|Lot-to-lot consistency is claimed if the 2-sided 95% CIs for the ratio of hSBA GMTs of antibodies against each of the serogroups A, C, W and Y is within the \[0.5;2.0\] equivalence interval for each pair of lots.|GMT ratio|0.83|||||TWO_SIDED|95.0|0.71|0.98||||||To demonstrate lot-to-lot consistency of the immune responses of ABCWY-1 and ABCWY-3 lots of the MenACWY component of the MenABCWY vaccine, as measured by hSBA GMTs directed against serogroup Y at 1 month after last vaccination (Day 211).||0.98|0.71|
72391508|NCT04502693|144290132|EQUIVALENCE|Lot-to-lot consistency is claimed if the 2-sided 95% CIs for the ratio of hSBA GMTs of antibodies against each of the serogroups A, C, W and Y is within the \[0.5;2.0\] equivalence interval for each pair of lots.|GMT ratio|0.97|||||TWO_SIDED|95.0|0.82|1.14||||||To demonstrate lot-to-lot consistency of the immune responses of ABCWY-2 and ABCWY-3 lots of the MenACWY component of the MenABCWY vaccine, as measured by hSBA GMTs directed against serogroup Y at 1 month after last vaccination (Day 211).||1.14|0.82|
72391509|NCT04502693|144290133|NON_INFERIORITY|Non-inferiority of MenABCWY vaccine is demonstrated if the LL of the 2-sided 95% CI for the difference in percentage of participants with 4-fold rise between the 2 groups is above -10%.|Difference in percentage of participants|11.29|||||TWO_SIDED|95.0|5.88|19.01|||Difference in percentage of participants|||To demonstrate the immunological non-inferiority of the MenABCWY vaccine compared to the MenACWY vaccine in participants without a previous MenACWY vaccination (unprimed) as measured by the percentages of participants, achieving a 4-fold rise in hSBA titers against N. meningitidis serogroup A at 1 month after the last MenABCWY vaccination (Day 211) and 1 month after the MenACWY vaccination.||19.01|5.88|
72391510|NCT04502693|144290133|NON_INFERIORITY|Non-inferiority of MenABCWY vaccine is demonstrated if the LL of the 2-sided 95% CI for the difference in percentage of participants with 4-fold rise between the 2 groups is above -10%.|Difference in percentage of participants|47.22|||||TWO_SIDED|95.0|38.14|56.3||||||To demonstrate the immunological non-inferiority of the MenABCWY vaccine compared to the MenACWY vaccine in participants without a previous MenACWY vaccination (unprimed) as measured by the percentages of participants, achieving a 4-fold rise in hSBA titers against N. meningitidis serogroup C at 1 month after the last MenABCWY vaccination (Day 211) and 1 month after the MenACWY vaccination.||56.30|38.14|
72391511|NCT04502693|144290133|NON_INFERIORITY|Non-inferiority of MenABCWY vaccine is demonstrated if the LL of the 2-sided 95% CI for the difference in percentage of participants with 4-fold rise between the 2 groups is above -10%.|Difference in percentage of participants|35.31|||||TWO_SIDED|95.0|26.88|44.49||||||To demonstrate the immunological non-inferiority of the MenABCWY vaccine compared to the MenACWY vaccine in participants without a previous MenACWY vaccination (unprimed) as measured by the percentages of participants, achieving a 4-fold rise in hSBA titers against N. meningitidis serogroup W at 1 month after the last MenABCWY vaccination (Day 211) and 1 month after the MenACWY vaccination.||44.49|26.88|
72391512|NCT04502693|144290133|NON_INFERIORITY|Non-inferiority of MenABCWY vaccine is demonstrated if the LL of the 2-sided 95% CI for the difference in percentage of participants with 4-fold rise between the 2 groups is above -10%.|Difference in percentage of participants|26.99|||||TWO_SIDED|95.0|19.38|35.81||||||To demonstrate the immunological non-inferiority of the MenABCWY vaccine compared to the MenACWY vaccine in participants without a previous MenACWY vaccination (unprimed) as measured by the percentages of participants, achieving a 4-fold rise in hSBA titers against N. meningitidis serogroup Y at 1 month after the last MenABCWY vaccination (Day 211) and 1 month after the MenACWY vaccination.||35.81|19.38|
72391513|NCT04502693|144290134|OTHER|Effectiveness of MenABCWY vaccine is demonstrated if the LL of the 2-sided 95% CI for VE against the selected strain panel between the ABCWY and the ACWY groups is above 65%. VE is defined as 1- RR = (1- percentage of samples without bactericidal serum activity at 1:4 dilution in ABCWY\_Pooled group / percentage of samples without bactericidal serum activity at 1:4 dilution in the ACWY group) x100 percentage.|VE|77.9|||||TWO_SIDED|95.0|76.6|79.2||||||To demonstrate the effectiveness of the MenABCWY vaccine against a randomly selected panel of endemic US N. meningitidis serogroup B invasive disease strains as measured by enc-hSBA at 1 month after the last MenABCWY vaccination (Day 211) when compared to 1 month after the MenACWY vaccination.||79.2|76.6|
72619944|NCT02539394|144770961|EQUIVALENCE|Two-sided||||||0.279|||||||Chi-squared|||Proportion of 4-6 weeks Bazaz Solid is the same between the 2 arms||||0.279
72619945|NCT02539394|144770962|EQUIVALENCE|Two-sided 95% confidence interval||||||0.145|||||||t-test, 2 sided|||The means Pre-operative NDI for the two populations is equal||||0.145
72619946|NCT02539394|144770962|EQUIVALENCE|Two-sided 95% confidence interval||||||0.234|||||||t-test, 2 sided|||The means 4-6 weeks NDI for the two populations is equal||||0.234
72619947|NCT02539394|144770967|SUPERIORITY|||||||0.99|||||||Fisher Exact|||||||0.99
72391514|NCT04502693|144290135|NON_INFERIORITY|Non-inferiority of MenABCWY to rMenB+OMV NZ is demonstrated if LL of the 2-sided 95% CI for the difference in percentages of samples with bactericidal serum activity at 1:4 dilution is above -5%.|Difference in percentage of participants|-0.61|||||TWO_SIDED|95.0|-1.25|0.03||||||To demonstrate the non-inferiority of the effectiveness of the MenABCWY vaccine (0,6-months schedule) compared to the rMenB+OMV NZ vaccine (0,2-months) in terms of percentage of samples with bactericidal serum activity using enc-hSBA against a randomly selected panel of endemic US N. meningitidis serogroup B invasive disease strains.||0.03|-1.25|
72391515|NCT00602797|144290167|OTHER|An interim analysis was conducted after 10 patients were accrued. Since response rate seen at the first interim analysis was superior to that seen with standard of care, a new monitoring rule was approved. Toxicity monitoring would occur after 19 patients. If 6/19 patients had ≥grade 4 non-hematological toxicity, accrual will be terminated. This will provide 84% power to detect 40% toxicity.|Proportion|6.0|||||TWO_SIDED||||||||If 6/19 patients had ≥grade 4 non-hematological toxicity, accrual will be terminated.|Adverse events will be graded using the NCI Common Toxicity Criteria (version 3.0).||||
72391516|NCT00418457|144290196|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.84|TWO_SIDED|95.0|0.74|1.28|||Regression, Cox|||||1.28|0.74|0.84
72391517|NCT00418457|144290197|SUPERIORITY||Odds Ratio (OR)|1.0||||0.7|TWO_SIDED|95.0|0.85|1.17|||GEE|||||1.17|0.85|0.70
72391518|NCT00418457|144290198|SUPERIORITY||Odds Ratio (OR)|0.98||||0.81|TWO_SIDED|95.0|0.75|1.28|||GEE|||||1.28|0.75|0.81
72391519|NCT00418457|144290199|SUPERIORITY||Mean Difference (Final Values)|-0.014||||0.96|TWO_SIDED|95.0|-0.63|0.6|||Mixed Models Analysis|||||0.60|-0.63|0.96
72499184|NCT00619957|144528711|SUPERIORITY_OR_OTHER||LS Mean Difference|-27.25|||<|0.0001|TWO_SIDED|95.0|-37.63|-16.87|||ANOVA|Fixed effects for treatment and pooled center.||A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.||-16.87|-37.63|<0.0001
72391520|NCT00418457|144290200|SUPERIORITY||Mean Difference (Final Values)|0.75||||0.043|TWO_SIDED|95.0|0.02|1.48|||Mixed Models Analysis|||||1.48|0.02|0.043
72391521|NCT03736447|144290201|SUPERIORITY||Risk Difference (RD)|67.2|||<|0.0001|TWO_SIDED|95.0|50.0|84.5|||Farrington-Manning test|||||84.5|50.0|<0.0001
72391522|NCT03736447|144290202|SUPERIORITY||Risk Difference (RD)|64.2|||<|0.0001|TWO_SIDED|95.0|47.0|81.4|||Farrington-Manning test|||||81.4|47.0|<0.0001
72391523|NCT03736447|144290203|SUPERIORITY||Risk Difference (RD)|56.7|||<|0.0001|TWO_SIDED|95.0|39.8|73.5|||Farrington-Manning test|||||73.5|39.8|<0.0001
72391524|NCT03547583|144290218|OTHER||Difference of LS-means|-0.52|||=|0.8008|TWO_SIDED|97.5|-5.17|4.13|||Mixed model repeated-measures|||The analysis of each imputed dataset will be performed using mixed-effects model for repeated measures (MMRM), including treatment, region, heart rhythm, study visit as fixed effects, interaction between study visit and treatment group, and adjustment for the baseline PLS values as covariates.||4.13|-5.17|= 0.8008
72391525|NCT03547583|144290218|OTHER||Difference of LS-means|-1.46|||=|0.4722|TWO_SIDED|97.5|-6.02|3.1|||Mixed model repeated-measures|||The analysis of each imputed dataset will be performed using mixed-effects model for repeated measures (MMRM), including treatment, region, heart rhythm, study visit as fixed effects, interaction between study visit and treatment group, and adjustment for the baseline PLS values as covariates.||3.10|-6.02|= 0.4722
72391526|NCT03547583|144290219|OTHER||Difference of LS-means|-1.81|||=|0.8054|TWO_SIDED|97.5|-18.3|14.67|||Mixed model repeated-measures|||The analysis of each imputed dataset will be performed using mixed-effects model for repeated measures (MMRM), including treatment, region, heart rhythm, study visit as fixed effects, interaction between study visit and treatment group, and adjustment for the baseline 6MWT values as covariates.||14.67|-18.30|= 0.8054
72391527|NCT03547583|144290219|OTHER||Difference of LS-means|-5.49|||=|0.4502|TWO_SIDED|97.5|-21.77|10.8|||mixed model repeated measures|||The analysis of each imputed dataset will be performed using mixed-effects model for repeated measures (MMRM), including treatment, region, heart rhythm, study visit as fixed effects, interaction between study visit and treatment group, and adjustment for the baseline 6MWT values as covariates.||10.80|-21.77|= 0.4502
72391528|NCT02657915|144290224|SUPERIORITY||Mean Difference (Final Values)|-6.0|||=|0.165|TWO_SIDED|95.0|-14.56|2.57|||ANCOVA|||||2.57|-14.56|=0.165
72391529|NCT02166905|144290233|OTHER||Hazard Ratio (HR)|0.4||||0.177|TWO_SIDED|90.0|0.1|1.2|||Log Rank||Reference=arm 1|||1.2|0.1|0.177
72391530|NCT02617628|144290239|EQUIVALENCE|The odds ratio for relapse versus non-relapse for the AR group relative to the BR group was analyzed, as well as the corresponding odds ratio for unknown relative to non-relapse.|Odds Ratio (OR)|1.56||||0.38|TWO_SIDED|95.0|0.57|4.27|||Regression, Logistic||Threshold for significance was set at p\<.05|Based on Lee et al. we estimated a 23-33% group difference in relapse by month 3. Power estimates calculated this estimate with a 2-sided alpha of .05 and a baseline sample size of 100 per group resulted in 80% power to detect a difference of approximately 20% (OR = 2.4) between groups assuming a rate of 50% in the control condition and 10% and 20% attrition by 3- and 6-month follow-ups. For the 86 participants randomized and released, with 80% power; and odds ratio of 3.5.||4.27|0.57|0.38
72391531|NCT02617628|144290240|SUPERIORITY||Cox Proportional Hazard|-0.74486||||0.01|TWO_SIDED|95.0|||||Regression, Cox|||We used Cox proportional hazards regression model to compare the groups on time to reincarceration.||||0.01
72391532|NCT02065375|144290241|SUPERIORITY||Difference in proportion of patients|-1.2||||0.4543|TWO_SIDED|95.0|-21.3|18.9|||Chi-squared|p values from Pearson chi-squared statistical test between the Omaveloxolone Ophthalmic suspension 1.0% and placebo were one sided.||||18.9|-21.3|0.4543
72391533|NCT02065375|144290241|SUPERIORITY||Difference in proportion of patients|8.2||||0.2297|TWO_SIDED|95.0|-13.5|29.8|||Chi-squared|p values from Pearson chi-squared statistical test between the Omaveloxolone Ophthalmic suspension 0.5% and placebo were one sided.||||29.8|-13.5|0.2297
72391534|NCT02065375|144290242|SUPERIORITY||Difference in proportion of patients|-21.6||||0.028|TWO_SIDED|95.0|-43.1|0.0|||Chi-squared|p values from Pearson chi-squared statistical test between the Omaveloxolone Ophthalmic suspension 1.0% and placebo were one sided.||||0.00|-43.1|.0280
72452058|NCT01074294|144426499|SUPERIORITY||Risk Ratio (RR)|0.99||||0.986|TWO_SIDED|95.0|0.46|2.13||The p-value was derived from CMH general association test controlling for study center.|Cochran-Mantel-Haenszel||The difference between LS means derived from the CMH model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Week 7||2.13|0.46|0.9860
72452059|NCT01074294|144426499|SUPERIORITY||Risk Ratio (RR)|1.01||||0.9858|TWO_SIDED|95.0|0.52|1.95||The p-value was derived from CMH general association test controlling for study center.|Cochran-Mantel-Haenszel||The difference between LS means derived from the CMH model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Week 8||1.95|0.52|0.9858
72499185|NCT00619957|144528712|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.14||||0.8794|TWO_SIDED|95.0|-1.99|1.71|||ANOVA|Fixed effects for treatment and pooled center.||A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.||1.71|-1.99|0.8794
72499186|NCT00619957|144528713|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.47||||0.6658|TWO_SIDED|95.0|-2.62|1.67|||ANOVA|Fixed effects for treatment and pooled center.||A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.||1.67|-2.62|0.6658
72452060|NCT01074294|144426499|SUPERIORITY||Risk Ratio (RR)|1.02||||0.9466|TWO_SIDED|95.0|0.58|1.78||The p-value was derived from CMH general association test controlling for study center.|Cochran-Mantel-Haenszel||The difference between LS means derived from the CMH model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Week 9||1.78|0.58|0.9466
72452061|NCT01074294|144426499|SUPERIORITY||Risk Ratio (RR)|1.12||||0.6962|TWO_SIDED|95.0|0.63|2.0||The p-value was derived from CMH general association test controlling for study center.|Cochran-Mantel-Haenszel||The difference between LS means derived from the CMH model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Week 10||2.00|0.63|0.6962
72452062|NCT01074294|144426499|SUPERIORITY||Risk Ratio (RR)|0.93||||0.7637|TWO_SIDED|95.0|0.57|1.51||The p-value was derived from CMH general association test controlling for study center.|Cochran-Mantel-Haenszel||The difference between LS means derived from the CMH model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Week 11||1.51|0.57|0.7637
72452063|NCT01074294|144426500|SUPERIORITY||Risk Ratio (RR)|1.3||||0.3631|TWO_SIDED|95.0|0.73|2.33||The p-value was derived from CMH general association test controlling for study center.|Cochran-Mantel-Haenszel||The difference between LS means derived from the CMH model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Week 6||2.33|0.73|0.3631
72452064|NCT01074294|144426500|SUPERIORITY||Risk Ratio (RR)|1.35||||0.2786|TWO_SIDED|95.0|0.78|2.35||The p-value was derived from CMH general association test controlling for study center.|Cochran-Mantel-Haenszel||The difference between LS means derived from the CMH model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Week 7||2.35|0.78|0.2786
72452065|NCT01074294|144426500|SUPERIORITY||Risk Ratio (RR)|1.08||||0.7062|TWO_SIDED|95.0|0.72|1.62||The p-value was derived from CMH general association test controlling for study center.|Cochran-Mantel-Haenszel||The difference between LS means derived from the CMH model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Week 8||1.62|0.72|0.7062
72452066|NCT01074294|144426500|SUPERIORITY||Risk Ratio (RR)|0.95||||0.7844|TWO_SIDED|95.0|0.67|1.35||The p-value was derived from CMH general association test controlling for study center.|Cochran-Mantel-Haenszel||The difference between LS means derived from the CMH model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Week 9||1.35|0.67|0.7844
72452067|NCT01074294|144426500|SUPERIORITY||Risk Ratio (RR)|1.07||||0.694|TWO_SIDED|95.0|0.77|1.48||The p-value was derived from CMH general association test controlling for study center.|Cochran-Mantel-Haenszel||The difference between LS means derived from the CMH model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Week 10||1.48|0.77|0.6940
72452068|NCT01074294|144426500|SUPERIORITY||Risk Ratio (RR)|1.03||||0.8697|TWO_SIDED|95.0|0.76|1.39||The p-value was derived from CMH general association test controlling for study center.|Cochran-Mantel-Haenszel||The difference between LS means derived from the CMH model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Week 11||1.39|0.76|0.8697
72452069|NCT01260896|144426518|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|106.84|||||TWO_SIDED|90.0|100.54|113.54|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||113.54|100.54|
72452070|NCT01260896|144426519|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|105.34|||||TWO_SIDED|90.0|100.37|110.55|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||110.55|100.37|
72619948|NCT01044693|144770974|SUPERIORITY_OR_OTHER|||||||0.036|TWO_SIDED||||||Mixed Models Analysis|||The main comparisons were between the active treatment groups versus placebo. We hypothesized that if NO-mediated vasodilation contributes to the BP-lowering effect of nebivolol then BP will be lowered by nebivolol and sildenafil, but not by metoprolol in autonomic failure patients.||||0.036
72452071|NCT01260896|144426520|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|103.12|||||TWO_SIDED|90.0|97.8|108.73|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||108.73|97.80|
72452072|NCT01260896|144426521|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|114.21|||||TWO_SIDED|90.0|109.29|119.35|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||119.35|109.29|
72452073|NCT01260896|144426522|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|108.26|||||TWO_SIDED|90.0|104.84|111.79|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||111.79|104.84|
72452074|NCT01260896|144426523|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|97.75|||||TWO_SIDED|90.0|92.92|102.85|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||102.85|92.92|
72452075|NCT00312208|144426527|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.0||||0.978||95.0|0.86|1.16||Cumulative incidence functions in each treatment group were calculated using non-parametric Kaplan-Meier estimates.|Log Rank|||||1.16|0.86|0.978
72452076|NCT00312208|144426528|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.91||||0.371||95.0|0.75|1.11||Cumulative incidences calculated in each group using non-parametric Kaplan-Meier estimates.|Log Rank|||||1.11|0.75|0.371
72452077|NCT04612244|144426550|NON_INFERIORITY|"PT will be deemed to be non-inferior to PC if it can be established that the posterior probability Pr(HA \| data) \> Ψeff, where Ψeff is a pre-specified threshold value that controls the one-sided type I error rate (under simulation) at level 0.05. In the absence of missing data, the posterior distributions for PT and PC would be conjugate Beta distributions."||||||0.05|||||||t-test, 1 sided|||"The primary effectiveness endpoint for this study is Treatment Success, which will be analyzed as a test of non-inferiority of the event rate at 12 months using a noninferiority margin of 15%.~The null and alternative hypotheses are:~H0: PT ≤ PC - 0.15 versus HA: PT \> PC - 0.15 where PT is the Treatment Success rate at 12 months in the Pulsed Field Group and PC is the Treatment Success rate at 12 months in the Thermal (Control) Group."||||0.05
72452078|NCT04612244|144426552|SUPERIORITY|"The null and alternative hypotheses are provided below. H0: PT ≤ PC versus HA: PT \> PC where PT is the Treatment Success rate at 12 months in the Pulsed Field Group, and PC is the Treatment Success rate at 12 months in the Thermal Group.~Modeling will be identical primary endpoint and superiority concluded if the posterior probability Pr(HA \| data) \> Ψeff, sup, where the threshold Ψeff,sup is a pre-specified threshold value that controls the one-sided type I error rate at level 0.025."|Median Difference (Final Values)|0.708||||0.025|ONE_SIDED|97.5|||||t-test, 1 sided|||The secondary effectiveness endpoint for the ADVENT Trial is Treatment Superiority uses the same definition as the primary effectiveness endpoint for Treatment Success, but the test is for superiority between MITT subjects in the PFA and Thermal Groups.||||0.025
72452079|NCT01371994|144426561|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1745|TWO_SIDED||||||Log Rank|Based on a Log-rank test stratified by (pooled) center and Baseline daily pad usage (≤ 3 and \> 3).||The treatment difference in the primary efficacy variable was tested using a log-rank test stratified by (pooled) center and by Baseline daily pad usage (≤3 and \>3) at a 2-sided significance level of 0.05.||||0.1745
72452080|NCT01371994|144426562|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4833|||||||Cochran-Mantel-Haenszel|Cochran-Mental-Haenszel test stratified by (pooled) center||Comparison at Week 4||||0.4833
72452081|NCT01371994|144426562|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5761|||||||Cochran-Mantel-Haenszel|Cochran-Mental-Haenszel test stratified by (pooled) center||Comparison at Week 8||||0.5761
72452082|NCT01371994|144426562|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0592|||||||Cochran-Mantel-Haenszel|Cochran-Mental-Haenszel test stratified by (pooled) center||Comparison at Week 12||||0.0592
72452083|NCT01371994|144426562|SUPERIORITY_OR_OTHER_LEGACY|||||||0.039|||||||Cochran-Mantel-Haenszel|Cochran-Mental-Haenszel test stratified by (pooled) center||Comparison of end of treatment analysis||||0.0390
72452084|NCT01371994|144426564|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|0.1|STANDARD_ERROR_OF_MEAN|0.13||0.3604|TWO_SIDED|95.0|-0.14|0.38|||ANCOVA|Based on an analysis of variance model including treatment and (pooled) center as fixed factors.||Comparison at Week 4||0.38|-0.14|0.3604
72452085|NCT01371994|144426564|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|0.2|STANDARD_ERROR_OF_MEAN|0.14||0.0761|TWO_SIDED|95.0|-0.03|0.52|||ANCOVA|Based on an analysis of variance model including treatment and (pooled) center as fixed factors.||Comparison at Week 8||0.52|-0.03|0.0761
72391535|NCT02065375|144290242|SUPERIORITY||Difference in proportion of patients|-24.0||||0.0192|TWO_SIDED|95.0|-45.8|-2.2|||Chi-squared|p values from Pearson chi-squared statistical test between the Omaveloxolone Ophthalmic suspension 0.5% and placebo were one sided.||||-2.2|-45.8|0.0192
72391536|NCT02801331|144290252|EQUIVALENCE|A test of equivalence was conducted for unadjusted comparisons. A chi squared test of proportions was used for unadjusted comparisons.||||||0.6||||||Unadjusted|Chi-squared|||||||.60
72391537|NCT02801331|144290253|EQUIVALENCE|A statistical test comparing cumulative morphine dose was performed for the cohort that was treated with morphine (n=60)||||||0.62|||||||t-test, 2 sided|degrees of freedom =58 for cohort analyzed that received morphine treatment.||||||.62
72391538|NCT02801331|144290254|EQUIVALENCE|A statistical test comparing day of life discharged among untreated infants who completed hospitalization at study site (n=181).||||||0.29|||||||t-test, 2 sided|df = 179 based on number of infants who completed hospitalization at study site.||||||0.29
72391539|NCT02801331|144290255|EQUIVALENCE|A statistical test comparing day of life discharged among untreated infants (n=121)||||||0.55|||||||t-test, 2 sided|df = 119 based on number of infants who did not receive morphine treatment.||||||0.55
72391540|NCT02801331|144290256|EQUIVALENCE|A statistical test comparing day of life discharged among treated infants, n=60||||||0.36|||||||t-test, 2 sided|df = 58 based on number of infants who received morphine treatment.||||||0.36
72391541|NCT02801331|144290257|EQUIVALENCE|A test of equivalence was conducted for unadjusted comparisons. A t test of means was used for unadjusted comparisons.||||||0.56|||||||t-test, 2 sided|df = 58 based on number of infants who received morphine treatment.||||||0.56
72391542|NCT02801331|144290258|EQUIVALENCE|A statistical test comparing day of life infant started treatment as performed for the cohort that was treated with morphine (n=60)||||||0.25|||||||t-test, 2 sided|df = 58 based on number of infants who received morphine treatment.||||||0.25
72391543|NCT05438888|144290276|OTHER||Hazard Ratio (HR)|0.753|||<|0.001|TWO_SIDED|95.0|0.711|0.798|||Log Rank|||||0.798|0.711|<0.001
72391544|NCT05438888|144290277|OTHER||Hazard Ratio (HR)|0.687|||<|0.001|TWO_SIDED|95.0|0.622|0.76|||Log Rank|||||0.760|0.622|<0.001
72391545|NCT05438888|144290278|OTHER||Hazard Ratio (HR)|0.638|||<|0.001|TWO_SIDED|95.0|0.57|0.714|||Log Rank|||||0.714|0.570|<0.001
72391546|NCT05438888|144290279|OTHER||Hazard Ratio (HR)|0.854|||<|0.001|TWO_SIDED|95.0|0.791|0.922|||Log Rank|||||0.922|0.791|<0.001
72391547|NCT05438888|144290280|OTHER||Hazard Ratio (HR)|0.638|||<|0.001|TWO_SIDED|95.0|0.57|0.715|||Log Rank|||||0.715|0.570|<0.001
72391548|NCT05438888|144290281|OTHER||Hazard Ratio (HR)|0.868|||<|0.001|TWO_SIDED|95.0|0.807|0.934|||Log Rank|||||0.934|0.807|<0.001
72391549|NCT05438888|144290282|OTHER||Hazard Ratio (HR)|0.646|||<|0.001|TWO_SIDED|95.0|0.503|0.83|||Log Rank|||||0.830|0.503|<0.001
72391550|NCT04249583|144290348|SUPERIORITY|||||||0.05|||||||Cochran-Mantel-Haenszel|||||||0.05
72391551|NCT02370160|144290351|OTHER||||||||||||||||||In Phase I: There were 9 subjects treated on dose level 1 (60 µg/kg/dose). There were 6 subjects treated on Dose level 2 (80 µg/kg/dose). There were four DLT events happened in Phase I. One was treated on dose level 1 and the other three were treated on dose level 2. Therefore the MTD was dose level 1.|||
72391552|NCT04487730|144290358|SUPERIORITY||Mean Difference (Final Values)|0.4727||||0.6249|TWO_SIDED||||||Mixed Models Analysis|||Functional connectivity within the orbital prefrontal cortex (OFC; specifically between lateral and medial OFC), significantly changed over time.||||0.6249
72391553|NCT04487730|144290359|SUPERIORITY||Mean Difference (Final Values)|3.8176||||0.525|TWO_SIDED||||||Mixed Models Analysis|||"Mixed effects model with a fixed effect for treatment and time, as well as time by treatment interaction, and a random effect for subject level.~F value for time by treatment interaction."||||.525
72452086|NCT01371994|144426564|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|0.4|STANDARD_ERROR_OF_MEAN|0.15||0.0149|TWO_SIDED|95.0|0.07|0.64|||ANCOVA|Based on an analysis of variance model including treatment and (pooled) center as fixed factors.||Comparison at Week 12||0.64|0.07|0.0149
72391554|NCT04487730|144290360|SUPERIORITY||Mean Difference (Final Values)|0.6503||||0.844|TWO_SIDED||||||Mixed Models Analysis|||"Mixed effects model with a fixed effect for treatment and time, as well as time by treatment interaction, and a random effect for subject level.~F value for time by treatment interaction."||||.844
72391555|NCT03291808|144290373|OTHER|||||||0.35|||||||Kruskal-Wallis|||||||.35
72391556|NCT01397084|144290414|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilocoxon signed-rank test|||Wilcoxon signed-rank test was used to check whether the change in the frequency of heartburn during the 7-day period prior to the 8 week visit (Visit 3) compared to the frequency of heartburn during the 7-day period prior to baseline (Visit 1) was statistically significant or not.||||<0.001
72391557|NCT02139228|144290418|SUPERIORITY_OR_OTHER||Vaccine Group Ratios|0.53|||||TWO_SIDED|95.0|0.36|0.76|||ANOVA|||||0.76|0.36|
72391558|NCT02139228|144290419|SUPERIORITY_OR_OTHER||Vaccine Group Differences|-11.0|||||TWO_SIDED|95.0|-18.6|-4.2|||Clopper-Pearson|||||-4.2|-18.6|
72391559|NCT00618072|144290425|SUPERIORITY_OR_OTHER|||||||0.181|||||||Paired t-test|||Paired t-tests were used to compare within-group mean differences at baseline and at 6 months following randomization for each of the 3 comparator groups.||||0.181
72391560|NCT00618072|144290425|SUPERIORITY_OR_OTHER|||||||0.026|||||||Paired t-test|||Paired t-tests were used to compare within-group mean differences at baseline and at 6 months following randomization for each of the 3 comparator groups.||||0.026
72391561|NCT00618072|144290425|SUPERIORITY_OR_OTHER|||||||0.063|||||||Paired t-test|||Paired t-tests were used to compare within-group mean differences at baseline and at 6 months following randomization for each of the 3 comparator groups.||||0.063
72391562|NCT00618072|144290426|SUPERIORITY_OR_OTHER|||||||0.049|||||||Paired t-test|||Paired t-tests were used to compare within-group mean differences at baseline and at 6 months following randomization for each of the 3 comparator groups.||||0.049
72391563|NCT00618072|144290426|SUPERIORITY_OR_OTHER|||||||0.002|||||||Paired t-test|||Paired t-tests were used to compare within-group mean differences at baseline and at 6 months following randomization for each of the 3 comparator groups.||||0.002
72391564|NCT00618072|144290426|SUPERIORITY_OR_OTHER|||||||0.032|||||||Paired t-test|||Paired t-tests were used to compare within-group mean differences at baseline and at 6 months following randomization for each of the 3 comparator groups.||||0.032
72452087|NCT01371994|144426564|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|0.3|STANDARD_ERROR_OF_MEAN|0.13||0.0325|TWO_SIDED|95.0|0.02|0.52|||ANCOVA|Based on an analysis of variance model including treatment and (pooled) center as fixed factors.||Comparison of end of treatment analysis||0.52|0.02|0.0325
72452088|NCT01371994|144426566|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|0.3|STANDARD_ERROR_OF_MEAN|0.46||0.5186|TWO_SIDED|95.0|-0.6|1.19|||ANCOVA|Based on an analysis of covariance (ANCOVA) model including Baseline value as a covariates and fixed effects for (pooled) center and treatment.||Comparison at Week 12||1.19|-0.60|0.5186
72452089|NCT01371994|144426566|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|0.3|STANDARD_ERROR_OF_MEAN|0.43||0.4521|TWO_SIDED|95.0|-0.52|1.17|||ANCOVA|Based on an analysis of covariance (ANCOVA) model including Baseline value as a covariates and fixed effects for (pooled) center and treatment.||Comparison of end of treatment analysis||1.17|-0.52|0.4521
72452090|NCT01371994|144426568|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|0.2|STANDARD_ERROR_OF_MEAN|0.14||0.1493|TWO_SIDED|95.0|-0.07|0.47|||ANCOVA|Based on an analysis of covariance (ANCOVA) model including Baseline value as a covariates and fixed effects for (pooled) center and treatment.||Comparison at Week 12||0.47|-0.07|0.1493
72452091|NCT01371994|144426568|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|0.2|STANDARD_ERROR_OF_MEAN|0.13||0.1499|TWO_SIDED|95.0|-0.07|0.44|||ANCOVA|Based on an analysis of covariance (ANCOVA) model including Baseline value as a covariates and fixed effects for (pooled) center and treatment.||Comparison of end of treatment analysis||0.44|-0.07|0.1499
72452092|NCT01371994|144426570|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|0.5|STANDARD_ERROR_OF_MEAN|0.35||0.1279|TWO_SIDED|95.0|-0.16|1.23|||ANCOVA|Based on an analysis of covariance (ANCOVA) model including Baseline value as a covariates and fixed effects for (pooled) center and treatment.||Comparison at Week 12||1.23|-0.16|0.1279
72452093|NCT01371994|144426570|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|0.6|STANDARD_ERROR_OF_MEAN|0.34||0.1038|TWO_SIDED|95.0|-0.11|1.23|||ANCOVA|Based on an analysis of covariance (ANCOVA) model including Baseline value as a covariates and fixed effects for (pooled) center and treatment.||Comparison of end of treatment analysis||1.23|-0.11|0.1038
72452094|NCT01371994|144426572|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|-0.3|STANDARD_ERROR_OF_MEAN|1.98||0.8876|TWO_SIDED|95.0|-4.19|3.63|||ANCOVA|Based on an analysis of covariance (ANCOVA) model including Baseline value as a covariates and fixed effects for (pooled) center and treatment.||Comparison at Week 12||3.63|-4.19|0.8876
72452095|NCT01371994|144426572|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|-2.4|STANDARD_ERROR_OF_MEAN|2.86||0.395|TWO_SIDED|95.0|-8.1|3.21|||ANCOVA|Based on an analysis of covariance (ANCOVA) model including Baseline value as a covariates and fixed effects for (pooled) center and treatment.||Comparison of end of treatment analysis||3.21|-8.10|0.3950
72452096|NCT01371994|144426574|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|2.0|STANDARD_ERROR_OF_MEAN|2.43||0.4126|TWO_SIDED|95.0|-2.82|6.81|||ANCOVA|Based on an analysis of covariance (ANCOVA) model including Baseline value as a covariates and fixed effects for (pooled) center and treatment.||Comparison at Week 12||6.81|-2.82|0.4126
72452097|NCT01371994|144426574|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|1.0|STANDARD_ERROR_OF_MEAN|2.47||0.6959|TWO_SIDED|95.0|-3.92|5.85|||ANCOVA|Based on an analysis of covariance (ANCOVA) model including Baseline value as a covariates and fixed effects for (pooled) center and treatment.||Comparison of end of treatment analysis||5.85|-3.92|0.6959
72499187|NCT00619957|144528714|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.29||||0.784|TWO_SIDED|95.0|-2.39|1.81|||ANOVA|Fixed effects for treatment and pooled center.||A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.||1.81|-2.39|0.7840
72452098|NCT01371994|144426576|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|3.3|STANDARD_ERROR_OF_MEAN|2.81||0.2402|TWO_SIDED|95.0|-2.26|8.91|||ANCOVA|Based on an analysis of covariance (ANCOVA) model including Baseline value as a covariates and fixed effects for (pooled) center and treatment.||Comparison at Week 12||8.91|-2.26|0.2402
72452099|NCT01371994|144426576|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|1.1|STANDARD_ERROR_OF_MEAN|2.83||0.698|TWO_SIDED|95.0|-4.5|6.7|||ANCOVA|Based on an analysis of covariance (ANCOVA) model including Baseline value as a covariates and fixed effects for (pooled) center and treatment.||Comparison of end of treatment analysis||6.70|-4.50|0.6980
72452100|NCT01371994|144426578|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|2.0|STANDARD_ERROR_OF_MEAN|2.46||0.4067|TWO_SIDED|95.0|-2.8|6.89|||ANCOVA|Based on an analysis of covariance (ANCOVA) model including Baseline value as a covariates and fixed effects for (pooled) center and treatment.||Comparison at Week 12||6.89|-2.80|0.4067
72499188|NCT00619957|144528715|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Cochran-Mantel-Haenszel|Controlled for pooled center.||A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.||||<0.0001
72499189|NCT00619957|144528716|SUPERIORITY_OR_OTHER||Relative Risk|0.771||||0.7284||95.0|0.184|3.226|||Log Rank|||A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.||3.226|0.184|0.7284
72499190|NCT00619957|144528717|SUPERIORITY_OR_OTHER||Relative Risk|0.688||||0.5293|TWO_SIDED|95.0|0.245|1.932|||Log Rank|||A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.||1.932|0.245|0.5293
72452101|NCT01371994|144426578|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|0.4|STANDARD_ERROR_OF_MEAN|2.36||0.8507|TWO_SIDED|95.0|-4.21|5.1|||ANCOVA|Based on an analysis of covariance (ANCOVA) model including Baseline value as a covariates and fixed effects for (pooled) center and treatment.||Comparison of end of treatment analysis||5.10|-4.21|0.8507
72391565|NCT00618072|144290427|SUPERIORITY_OR_OTHER|||||||0.142|||||||Paired t-test|||Paired t-tests were used to compare within-group mean differences at baseline and at 6 months following randomization for each of the 3 comparator groups.||||0.142
72452102|NCT01371994|144426579|SUPERIORITY_OR_OTHER_LEGACY|||||||0.27|||||||Log Rank|Based on a Log-rank test stratified by (pooled) center.||||||0.2700
72391566|NCT00618072|144290427|SUPERIORITY_OR_OTHER|||||||0.054|||||||Paired t-test|||Paired t-tests were used to compare within-group mean differences at baseline and at 6 months following randomization for each of the 3 comparator groups.||||0.054
72452103|NCT03211247|144426612|OTHER||Proportion difference|33.4|||<|0.001|TWO_SIDED|95.0|22.36|44.49|||Wald test||The 2-sided Farrington-Manning 95% confidence interval for the difference in response rates was calculated.|Analysis of the difference in response rates between DBV712 250 μg group and Placebo group and 2-sided Farrington-Manning 95% confidence interval (CI). P-value was obtained from a 2-sided 5% test to evaluate the null hypothesis of no difference in response rates between treatment groups using the Wald method. Clinical relevance was evaluated based on the lower bound of the Farrignton-Manning 95% CI of the difference in response rates ≥15%.||44.49|22.36|<0.001
72391567|NCT00618072|144290427|SUPERIORITY_OR_OTHER|||||||0.013|||||||Paired t-test|||Paired t-tests were used to compare within-group mean differences at baseline and at 6 months following randomization for each of the 3 comparator groups.||||0.013
72391568|NCT00618072|144290428|SUPERIORITY_OR_OTHER|||||||0.052|||||||Paired t-test|||Paired t-tests were used to compare within-group mean differences at baseline and at 6 months following randomization for each of the 3 comparator groups.||||0.052
72391569|NCT00618072|144290428|SUPERIORITY_OR_OTHER|||||||0.143|||||||Paired t-test|||Paired t-tests were used to compare within-group mean differences at baseline and at 6 months following randomization for each of the 3 comparator groups.||||0.143
72391570|NCT00618072|144290428|SUPERIORITY_OR_OTHER|||||||0.005|||||||Paired t-test|||Paired t-tests were used to compare within-group mean differences at baseline and at 6 months following randomization for each of the 3 comparator groups.||||0.005
72391571|NCT00618072|144290429|SUPERIORITY_OR_OTHER|||||||0.265|||||||Paired t-test|||Paired t-tests were used to compare within-group mean differences at baseline and at 6 months following randomization for each of the 3 comparator groups.||||0.265
72391572|NCT00618072|144290429|SUPERIORITY_OR_OTHER|||||||0.001|||||||Paired t-test|||Paired t-tests were used to compare within-group mean differences at baseline and at 6 months following randomization for each of the 3 comparator groups.||||0.001
72391573|NCT00618072|144290429|SUPERIORITY_OR_OTHER|||||||0.389|||||||Paired t-test|||Paired t-tests were used to compare within-group mean differences at baseline and at 6 months following randomization for each of the 3 comparator groups.||||0.389
72391574|NCT00618072|144290430|SUPERIORITY_OR_OTHER|||||||0.025|||||||Paired t-test|||Paired t-tests were used to compare within-group mean differences at baseline and at 6 months following randomization for each of the 3 comparator groups.||||0.025
72391575|NCT00618072|144290430|SUPERIORITY_OR_OTHER|||||||0.162|||||||Paired t-test|||Paired t-tests were used to compare within-group mean differences at baseline and at 6 months following randomization for each of the 3 comparator groups.||||0.162
72391576|NCT00618072|144290430|SUPERIORITY_OR_OTHER|||||||0.562|||||||Paired t-test|||Paired t-tests were used to compare within-group mean differences at baseline and at 6 months following randomization for each of the 3 comparator groups.||||0.562
72391577|NCT00618072|144290431|SUPERIORITY_OR_OTHER|||||||0.016|||||||Paired t-test|||Paired t-tests were used to compare within-group mean differences at baseline and at 6 months following randomization for each of the 3 comparator groups.||||0.016
72391578|NCT00618072|144290431|SUPERIORITY_OR_OTHER|||||||0.03|||||||Paired t-test|||Paired t-tests were used to compare within-group mean differences at baseline and at 6 months following randomization for each of the 3 comparator groups.||||0.03
72391579|NCT00618072|144290431|SUPERIORITY_OR_OTHER|||||||0.15|||||||Paired t-test|||Paired t-tests were used to compare within-group mean differences at baseline and at 6 months following randomization for each of the 3 comparator groups.||||0.150
72391580|NCT00618072|144290432|SUPERIORITY_OR_OTHER|||||||0.648|||||||Paired t-test|||Paired t-tests were used to compare within-group mean differences at baseline and at 6 months following randomization for each of the 3 comparator groups.||||0.648
72391581|NCT00618072|144290432|SUPERIORITY_OR_OTHER|||||||0.094|||||||Paired t-test|||Paired t-tests were used to compare within-group mean differences at baseline and at 6 months following randomization for each of the 3 comparator groups.||||0.094
72391582|NCT00618072|144290432|SUPERIORITY_OR_OTHER|||||||0.054|||||||Paired t-test|||Paired t-tests were used to compare within-group mean differences at baseline and at 6 months following randomization for each of the 3 comparator groups.||||0.054
72391583|NCT00618072|144290433|SUPERIORITY_OR_OTHER|||||||0.092|||||||Paired t-test|||Paired t-tests were used to compare within-group mean differences at baseline and at 6 months following randomization for each of the 3 comparator groups.||||0.092
72391584|NCT00618072|144290433|SUPERIORITY_OR_OTHER|||||||0.73|||||||Paired t-test|||Paired t-tests were used to compare within-group mean differences at baseline and at 6 months following randomization for each of the 3 comparator groups.||||0.730
72391585|NCT00618072|144290433|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Paired t-test|||Paired t-tests were used to compare within-group mean differences at baseline and at 6 months following randomization for each of the 3 comparator groups.||||<0.001
72391586|NCT03292588|144290434|SUPERIORITY|Negative binomial model for the rate of exacerbations in the first year. The model included an offset term to account for differential follow-up among participants. To account for adaptive randomization, the model was also adjusted for study site, number of exacerbations in year prior to study (2 or 3+), peripheral blood eosinophils (\< or ≥400 cells/μl), BMI (\< or ≥95th percentile for age), total serum IgE (\< or ≥540 kUA/L) and treatment dose (40 mg or 100 mg).|Risk Ratio (RR)|0.73||||0.027|TWO_SIDED|95.0|0.56|0.96|||Regression, Negative Binomial|Adjusted relative rate of exacerbations in the first year.||||0.96|0.56|0.027
72452104|NCT04538352|144426648|OTHER|p value of contrast difference compared from MDI to Semaglutide group at specific time point, testing whether contrast difference is equal to 0, which means there is no difference between two groups. The determination of statistical significance was made using Bonferroni-adjusted p-value, setting the significance threshold at 0.01 after multiplicity correction.||||||0.009||||||p value is adjusted for the multiple comparison. The significance threshold is set to 0.01.|Bonferroni-adjusted p-value|||"Linear mixed effect model was conducted for each endpoint to assess mean change at each time point, with time, treatment groups, the interaction of treatment groups and time, and baseline variables included and adjusted in each model.~Mean change difference between patients with MDI and those with Semaglutide (MDI - Semaglutide)"||||0.009
72452105|NCT04538352|144426649|OTHER|p value of contrast difference compared from MDI to Semaglutide group at specific time point, testing whether contrast difference is equal to 0, which means there is no difference between two groups. The determination of statistical significance was made using Bonferroni-adjusted p-value, setting the significance threshold at 0.01 after multiplicity correction.|||||<|0.001||||||p value is adjusted for the multiple comparison. The significance threshold is set to 0.01.|Bonferroni-adjusted p-value|||"Linear mixed effect model was conducted for each endpoint to assess mean change at each time point, with time, treatment groups, the interaction of treatment groups and time, and baseline variables included and adjusted in each model.~Mean change difference between patients with MDI and those with Semaglutide (MDI - Semaglutide)"||||<0.001
72452106|NCT02278185|144426667|SUPERIORITY|||||||0.46|||||||Chi-squared|||The difference between metabolic syndrome and treatment were evaluated with the Chi-square test|This study did not meet it's target accrual goal and thus is underpowered to detect a statistically significant difference between the two groups.|||0.46
72452107|NCT02278185|144426667|SUPERIORITY|||||||0.46|||||||Chi-squared|||Cohort characteristics for Metabolic Syndrome were summarized by event and arm using counts and percentages for categorical variables and the mean, standard deviation, median, and quartiles for continuous variables. The difference between metabolic syndrome and treatment were evaluated with the Chi-square test. P-values are reported based on a null hypothesis of no difference against a two-sided alternative. Analyses were performed using SAS 9.4 (SAS Inst|Cohort characteristics for Metabolic Syndrome, the SPPB, the SHIM/FACT-P, and PSA were summarized by event and arm using counts and percentages for categorical variables and the mean, standard deviation, median, and quartiles for continuous variables. The difference between metabolic syndrome and treatment were evaluated with the Chi-square test. The Wilcoxon signed-rank test was utilized to examine the difference between Month 1 and Month 12 SPPB scores. The Wilcoxon rank-sum test was used to assess the difference of SHIM/FACT-P scores and PSA between arms. These tests were chosen to account for the non-normal distributions of the continuous variables. The difference between PSA progression between arms was examined using the Fisher Exact Test. A heat map of scores ordered by the highest average score was also created. P-values are reported based on a null hypothesis of no difference against a two-sided alternative. Analyses were performed using SAS 9.4 (SAS Inst|||0.46
72452108|NCT02278185|144426678|SUPERIORITY|||||||0.5|||||||Wilcoxon (Mann-Whitney)|||The results are presented in the following format: N Mean (Std Dev) Median (Q1, Q3). In all cases (Overall, Arm 1, and Arm 2) we fail to reject the null hypothesis that the samples come from the same population of scores at Month 1 versus Month 12 at the 0.05 significance level.||||0.5
72452109|NCT01617369|144426714|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|||Paired t-test performed. Null hypothesis is that no difference in clearance 30 min and 4 hr after HS inhalation exists||||<.05
72452110|NCT01574716|144426743|SUPERIORITY||Hazard Ratio (HR)|1.08|||=|0.6562|TWO_SIDED|95.0|0.77|1.5|||Log Rank|Two-sided log-rank test|Based on Cox PH model|||1.50|0.77|= 0.6562
72452111|NCT01574716|144426744|SUPERIORITY||Hazard Ratio (HR)|1.13|||=|0.4469|TWO_SIDED|95.0|0.82|1.57|||Log Rank|Two-sided log-rank test|Based on Cox PH model|||1.57|0.82|=0.4469
72452112|NCT01574716|144426745|SUPERIORITY||Hazard Ratio (HR)|1.23||||0.3153|TWO_SIDED|95.0|0.82|1.83|||Log Rank|Two-sided log-rank test|Based on Cox PH model|||1.83|0.82|0.3153
72452113|NCT01574716|144426746|SUPERIORITY||Difference|-0.6|||=|1|TWO_SIDED|95.0|-12.0|10.9|||Log Rank|Two-sided log-rank test|Based on Cox PH model|Difference equal to (=) (MORAb 8.0 mg/kg + Gemcitabine/Docetaxel) minus (Placebo + Gemcitabine/Docetaxel). Confidence interval based on a normal approximation to the binomial distribution.||10.9|-12.0|= 1.000
72452114|NCT02438137|144426749|SUPERIORITY|In multiple linear regression models, the effect of DMF treatment on mean RDI change (beta-coefficient) was -11.3 respiratory events per hour (p=0.0124).|beta-coefficient for treatment effect|-11.3|STANDARD_ERROR_OF_MEAN|4.3||0.0124|TWO_SIDED||||||Regression, Linear|||Multiple linear regression models were used to calculate treatment effect (DMF or placebo) on mean RDI change, controlling for change in age, gender, BMI, time spent in supine sleep, and time spent in REM sleep.|A mixed effects model, which treated RDI as a repeated measure and used individual ID as random effect, adjusted for age, gender, BMI, time spent in supine sleep, was also conducted. In this model, the effect of DMF compared to placebo, controlling for all other covariates, is a 28% decrease in Month 4 RDI (p=0.033).|||0.0124
72452115|NCT04868617|144426797|SUPERIORITY||Mean Difference (Final Values)|-0.2|||=|0.015|TWO_SIDED|95.0|-0.3|-0.03|||Mixed Models Analysis|||||-0.03|-0.3|=0.015
72452116|NCT04868617|144426798|SUPERIORITY||Mean Difference (Final Values)|-0.8|||=|0.035|TWO_SIDED|95.0|-1.5|-0.1|||Mixed Models Analysis|||||-0.1|-1.5|=0.035
72452117|NCT01970007|144426860|OTHER||Freedom from MAE rate (%)|96.7|||<|0.0001|TWO_SIDED|95.0|93.5|98.6|||One-sided Exact binomial test||One-sided Exact binomial test|||98.6|93.5|<0.0001
72452118|NCT01970007|144426861|OTHER||12-month quantitative patency rate (%)|89.9|||<|0.0001|TWO_SIDED|95.0|85.1|93.4|||Binomial test for one proportion||Binomial test for one proportion|||93.4|85.1|<0.0001
72391587|NCT03292588|144290435|SUPERIORITY||Least Square Mean Difference|-0.28||||0.29|TWO_SIDED|95.0|-0.81|0.24|||Mixed Models Analysis|The difference in least square mean of CASI scores for week 12.||Week 12||0.24|-0.81|0.290
72452119|NCT01970007|144426862|OTHER||Change from Baseline Mean|-3.0|||<|0.0001|TWO_SIDED|95.0|-3.5|-2.6||P-value is adjusted for multiplicity|paired t-test|A paired t-test with p-values adjusted for multiple comparisons using the Holm's procedure to control for a family-wise Type I error rate of 0.05.||||-2.6|-3.5|<0.0001
72452120|NCT01970007|144426863|OTHER||Change from Baseline Mean|-4.2|||<|0.0001|TWO_SIDED|95.0|-4.7|-3.7||p-value is adjusted for multiplicity.|pair t-test|A paired t-test with p-values adjusted for multiple comparisons using the Holm's procedure to control for a family-wise Type I error rate of 0.05||||-3.7|-4.7|<0.0001
72452121|NCT03170648|144426910|OTHER|||||||0.02||||||T2 (post) vs.T1(pre)|t-test, 2 sided|||||||0.02
72452122|NCT03509909|144426912|SUPERIORITY|||||||0.74|||||||Mixed Models Analysis|||||||0.74
72452123|NCT03500549|144426918|SUPERIORITY|The primary endpoint analysis was a between-treatment-group comparison using a mixed effect model for repeated measures (MMRM). The difference between pegcetacoplan and eculizumab LS mean Hb changes from Baseline at Week 16 was calculated along with its 2-sided 95% confidence interval (CI) and associated P-value from the MMRM model for the ITT set, censored for transfusions.|LS mean difference|3.84|||<|0.0001|TWO_SIDED|95.0|2.33|5.34||Superiority was tested at the 5% level. MMRM includes treatment + baseline value + analysis visit + strata + analysis visit × treatment, where strata is the combination of randomization stratification factors.|MMRM|||||5.34|2.33|<0.0001
72452124|NCT03500549|144426919|NON_INFERIORITY|Analysis was based on prespecified non-inferiority margins (NIM) and non-inferiority was achieved if the lower confidence limit or upper confidence limit of the 95% CI of the treatment difference met the prespecified NIM of -20%. Stratified Cochran-Mantel Haenszel (CMH) chi-square test was used for treatment comparison and the 95% CI for difference in percentage between treatments is constructed using the stratified (Miettinen-Nurminen) method.|Risk Difference (RD)|0.6253|||<|0.0001|TWO_SIDED|95.0|0.483|0.7677||Non-inferiority was tested at the 2.5% level.|Miettinen-Nurminen|||||0.7677|0.4830|<0.0001
72562153|NCT01294449|144655647|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.88||||0.37|TWO_SIDED|95.0|0.67|1.161|||Regression, Cox||The hazard ratio was calculated as the hazard rate of mortality in the CRT-D group over the hazard rate of mortality in the ICD group. A hazard ratio lower than 1 represents a reduction in relative risk of mortality for CRT-D compared to ICD.|The sample size for the analysis included subjects from the original MADIT-CRT IDE (NCT00180271) that did not participate in the Registry portion, these subjects are censored at the time of study conclusion, withdrawal or death during the IDE. This was done as the Registry is a post approval continuation of the follow-up from the MADIT-CRT IDE trial. This is not a pooled analysis from separate studies.||1.161|0.670|0.370
72562154|NCT01294449|144655647|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.68||||0.028|TWO_SIDED|95.0|0.484|0.96|||Regression, Cox||The hazard ratio was calculated as the hazard rate of mortality in the CRT-D arm over the hazard rate of mortality in the ICD arm. A hazard ratio lower than 1 represents a reduction in relative risk of mortality for CRT-D compared to ICD.|These data represent the indicated sub population of left bundle branch block subjects only. (Left bundle branch block N= 110 ICD group: 181 CRT-D group)||0.960|0.484|0.028
72562155|NCT03222037|144655648|NON_INFERIORITY|Non-inferiority was declared if the upper limit of the 97.5% confidence interval was below 0.05.|Mean Difference (Final Values)|-0.06|STANDARD_ERROR_OF_MEAN|0.02|||TWO_SIDED|97.5|-0.09|-0.02|||Linear Mixed Model|Linear mixed model with Kenward and Roger method for degrees of freedom|Mean difference was calculated as Test- SCR. This comparison is for high lumniance low contrast|Comparison between the Test and the SCR treatments was carried out using 97.5% confidence intervals for the least-square mean differences.||-0.02|-0.09|
72562156|NCT03222037|144655648|NON_INFERIORITY|Non-inferiority was declared if the upper limit of the 97.5% confidence interval was below 0.05|Median Difference (Final Values)|-0.03|STANDARD_ERROR_OF_MEAN|0.01|||TWO_SIDED|97.5|-0.06|-0.01|||Linear Mixed Model|Linear mixed model with Kenward and Roger method for denominator degrees of freedom|Mean difference was calculated as Test- SCR. This comparison is for Low luminance high contrast|||-0.01|-0.06|
72562157|NCT03222037|144655649|EQUIVALENCE|Statistical significance is declared if the lower limit of the 95% confidence interval is above 0 or if the upper limit of the 95% confidence interval is below 0.|Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.02||0.0066|TWO_SIDED|95.0|0.01|0.08|||Linear Mixed Model|Linear Mixed Model with Kenward and Roger method for the denominator degrees of freedom.|Mean difference was calculated as Test - SCR.|Comparison between the Test and SCR treatments was carried out using least-square mean differences||0.08|0.01|0.0066
72562158|NCT00496262|144655650|SUPERIORITY_OR_OTHER||Mean Difference (Net)|8.9|STANDARD_DEVIATION|4.4|<|0.0001||90.0|||||2-sided, 1-sample t-test||The entire ITT population was used for a conservative analysis of the mean change in MCF. The mean change was set to 0 for any subject with missing MCF data.|This is an open-label study with statistical comparison between MCF pre-infusion and 1 hour post-infusion.||||<0.0001
72619949|NCT01044693|144770974|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||The main comparisons were between the active treatment groups versus placebo. We hypothesized that if NO-mediated vasodilation contributes to the BP-lowering effect of nebivolol then BP will be lowered by nebivolol and sildenafil, but not by metoprolol in autonomic failure patients.||||<0.001
72619950|NCT01044693|144770974|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Mixed Models Analysis|||The main comparisons were between the active treatment groups versus placebo. We hypothesized that if NO-mediated vasodilation contributes to the BP-lowering effect of nebivolol then BP will be lowered by nebivolol and sildenafil, but not by metoprolol in autonomic failure patients.||||>0.05
72619951|NCT01044693|144770975|SUPERIORITY_OR_OTHER|||||||0.607|TWO_SIDED||||||ANOVA|||The main comparisons were between the active treatment groups versus placebo.||||0.607
72619952|NCT01044693|144770976|SUPERIORITY_OR_OTHER|||||||0.597|TWO_SIDED||||||ANOVA|||The main comparisons were between the active treatment groups versus placebo.||||0.597
72391588|NCT03292588|144290435|SUPERIORITY||Least Square Mean Difference|-0.07||||0.82|TWO_SIDED|95.0|-0.69|0.55|||Mixed Models Analysis|The difference in least square mean of CASI scores for week 24.||Week 24||0.55|-0.69|0.820
72619953|NCT01044693|144770977|SUPERIORITY_OR_OTHER|||||||0.996|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||The main comparisons were between the negative chronotropic effect of nebivolol and metoprolol at the time when BP-lowering effects were maximal.||||0.996
72619954|NCT02205359|144770978|SUPERIORITY||Hazard Ratio (HR)|0.888|STANDARD_ERROR_OF_MEAN|0.067||0.077|TWO_SIDED|95.0|0.779|1.013|||Regression, Cox|Stratified by NYHA class and with investigational site as a random effect|Stratified by NYHA class and with investigational site as a random effect, Standard Error reported on log hazard scale|||1.013|0.779|0.077
72499191|NCT00868790|144528724|SUPERIORITY_OR_OTHER||Least Squares Mean (LSM) Difference|-17.2||||0.013|TWO_SIDED|90.0|-28.3|-6.1|||LDA Model|Between-group difference (MK-3577-placebo) of LSM changes from BL to a given time point and 90% confidence intervals were estimated from LDA model.||Analysis based on an LDA model including terms for treatment, period, the interaction of treatment by period, prior antihyperglycemic therapy status (yes/no), and randomization stratum (participation in domiciled visits \[yes/no\]). The LDA-model test was conducted at alpha level=0.10 (two sided).||-6.1|-28.3|0.013
72499192|NCT00868790|144528724|SUPERIORITY_OR_OTHER||LSM Difference|-23.4|||<|0.001|TWO_SIDED|90.0|-34.5|-12.4|||LDA Model|Between-group difference (MK-3577-placebo) of LSM changes from BL to a given time point and 90% confidence intervals were estimated from LDA model.||Analysis based on an LDA model including terms for treatment, period, the interaction of treatment by period, prior antihyperglycemic therapy status (yes/no), and randomization stratum (participation in domiciled visits \[yes/no\]). The LDA-model test was conducted at alpha level=0.10 (two sided).||-12.4|-34.5|<0.001
72499193|NCT00868790|144528724|SUPERIORITY_OR_OTHER||LSM Difference|-34.9|||<|0.001|TWO_SIDED|95.0|-44.8|-25.0|||LDA Model|Between-group difference (metformin-placebo) of LSM changes from BL to a given time point and 90% confidence intervals were estimated from LDA model.||Analysis based on an LDA model including terms for treatment, period, the interaction of treatment by period, prior antihyperglycemic therapy status (yes/no), and randomization stratum (participation in domiciled visits \[yes/no\]). The LDA-model test was conducted at alpha level=0.10 (two sided).||-25.0|-44.8|<0.001
72499194|NCT00868790|144528725|SUPERIORITY_OR_OTHER||LSM Difference|-11.5||||0.002|TWO_SIDED|90.0|-17.5|-5.4|||LDA Model|Between-group difference (MK-3577-placebo) of LSM changes from BL to a given time point and 90% confidence intervals were estimated from LDA model.||Analysis based on an LDA model including terms for treatment, period, the interaction of treatment by period, prior antihyperglycemic therapy status (yes/no), and randomization stratum (participation in domiciled visits \[yes/no\]). The LDA-model test was conducted at alpha level=0.10 (two sided).||-5.4|-17.5|0.002
72499195|NCT00868790|144528725|SUPERIORITY_OR_OTHER||LSM Difference|-21.8|||<|0.001|TWO_SIDED|90.0|-27.8|-15.8|||LDA Model|Between-group difference (MK-3577-placebo) of LSM changes from BL to a given time point and 90% confidence intervals were estimated from LDA model.||Analysis based on an LDA model including terms for treatment, period, the interaction of treatment by period, prior antihyperglycemic therapy status (yes/no), and randomization stratum (participation in domiciled visits \[yes/no\]). The LDA-model test was conducted at alpha level=0.10 (two sided).||-15.8|-27.8|<0.001
72499196|NCT00868790|144528725|SUPERIORITY_OR_OTHER||LSM Difference|-36.0|||<|0.001|TWO_SIDED|90.0|-42.0|-30.0|||LDA Model|Between-group difference (MK-3577-placebo) of LSM changes from BL to a given time point and 90% confidence intervals were estimated from LDA model.||Analysis based on an LDA model including terms for treatment, period, the interaction of treatment by period, prior antihyperglycemic therapy status (yes/no), and randomization stratum (participation in domiciled visits \[yes/no\]). The LDA-model test was conducted at alpha level=0.10 (two sided).||-30.0|-42.0|<0.001
72499197|NCT00868790|144528725|SUPERIORITY_OR_OTHER||LSM Difference|-20.0||||0.001|TWO_SIDED|90.0|-30.0|-10.1|||LDA Model|Between-group difference (metformin-placebo) of LSM changes from BL to a given time point and 90% confidence intervals were estimated from LDA model.||Analysis based on an LDA model including terms for treatment, period, the interaction of treatment by period, prior antihyperglycemic therapy status (yes/no), and randomization stratum (participation in domiciled visits \[yes/no\]). The LDA-model test was conducted at alpha level=0.10 (two sided).||-10.1|-30.0|0.001
72499198|NCT00868790|144528726|SUPERIORITY_OR_OTHER||LSM Difference|-14.9||||0.174|TWO_SIDED|90.0|-33.0|3.2|||LDA Model|Between-group difference (MK-3577-placebo) of LSM changes from BL to a given time point and 90% confidence intervals were estimated from LDA model.||Analysis based on an LDA model including terms for treatment, period, the interaction of treatment by period, prior antihyperglycemic therapy status (yes/no), and randomization stratum (participation in domiciled visits \[yes/no\]). The LDA-model test was conducted at alpha level=0.10 (two sided).||3.2|-33.0|0.174
72499199|NCT00868790|144528726|SUPERIORITY_OR_OTHER||LSM Difference|-20.4||||0.063|TWO_SIDED|90.0|-38.4|-2.4|||LDA Model|Between-group difference (MK-3577-placebo) of LSM changes from BL to a given time point and 90% confidence intervals were estimated from LDA model.||Analysis based on an LDA model including terms for treatment, period, the interaction of treatment by period, prior antihyperglycemic therapy status (yes/no), and randomization stratum (participation in domiciled visits \[yes/no\]). The LDA-model test was conducted at alpha level=0.10 (two sided).||-2.4|-38.4|0.063
72499200|NCT00868790|144528726|SUPERIORITY_OR_OTHER||LSM Difference|-78.1|||<|0.001|TWO_SIDED|90.0|-96.4|-59.8|||LDA Model|Between-group difference (MK-3577-placebo) of LSM changes from BL to a given time point and 90% confidence intervals were estimated from LDA model.||Analysis based on an LDA model including terms for treatment, period, the interaction of treatment by period, prior antihyperglycemic therapy status (yes/no), and randomization stratum (participation in domiciled visits \[yes/no\]). The LDA-model test was conducted at alpha level=0.10 (two sided).||-59.8|-96.4|<0.001
72499201|NCT00868790|144528726|SUPERIORITY_OR_OTHER||LSM Difference|-49.4|||<|0.001|TWO_SIDED|90.0|-66.9|-31.8|||LDA Model|Between-group difference (metformin-placebo) of LSM changes from BL to a given time point and 90% confidence intervals were estimated from LDA model.||Analysis based on an LDA model including terms for treatment, period, the interaction of treatment by period, prior antihyperglycemic therapy status (yes/no), and randomization stratum (participation in domiciled visits \[yes/no\]). The LDA-model test was conducted at alpha level=0.10 (two sided).||-31.8|-66.9|<0.001
72619955|NCT02205359|144770979|SUPERIORITY||Hazard Ratio (HR)|0.881|STANDARD_ERROR_OF_MEAN|0.081||0.12|TWO_SIDED|95.0|0.752|1.032|||Regression, Cox|Stratified by NYHA class and with investigational site as a random effect|Stratified by NYHA class and with investigational site as a random effect, Standard Error reported on log hazard scale|||1.032|0.752|0.12
72619956|NCT02205359|144770980|SUPERIORITY||Hazard Ratio (HR)|0.906|STANDARD_ERROR_OF_MEAN|0.09||0.28|TWO_SIDED|95.0|0.759|1.082|||Regression, Cox|Stratified by NYHA class and with investigational site as a random effect|Stratified by NYHA class and with investigational site as a random effect, Standard Error reported on log hazard scale|||1.082|0.759|0.28
72619957|NCT02205359|144770981|SUPERIORITY|Endpoint for statistical analysis is the proportion Improved.|Odds Ratio (OR)|0.888|STANDARD_ERROR_OF_MEAN|0.074||0.11|TWO_SIDED|95.0|0.768|1.026|||Regression, Logistic|Stratified by NYHA class and with investigational site as a random effect|Standard Error is on log-odds ratio scale|||1.026|0.768|0.11
72499202|NCT00868790|144528727|SUPERIORITY_OR_OTHER||LSM Difference|-0.8||||0.742|TWO_SIDED|90.0|-4.6|3.1|||LDA Model|||LDL-C values after log transformation were analyzed using a constrained LDA model that included terms for treatment, period, the interaction of treatment by period, prior antihyperglycemic therapy status (yes/no), and randomization stratum (participation in domiciled visits \[yes/no\]). Percentage change from baseline in LDL-C after 4-week treatment was reported, after back-transformation using the delta method with an alpha-level of 0.10 (2-sided).||3.1|-4.6|0.742
72499203|NCT00868790|144528727|SUPERIORITY_OR_OTHER||LSM Difference|4.5||||0.06|TWO_SIDED|90.0|0.6|8.4|||LDA Model|||LDL-C values after log transformation were analyzed using a constrained LDA model that included terms for treatment, period, the interaction of treatment by period, prior antihyperglycemic therapy status (yes/no), and randomization stratum (participation in domiciled visits \[yes/no\]). Percentage change from baseline in LDL-C after 4-week treatment was reported, after back-transformation using the delta method with an alpha-level of 0.10 (2-sided).||8.4|0.6|0.060
72499204|NCT00868790|144528727|SUPERIORITY_OR_OTHER||LSM Difference|7.8||||0.002|TWO_SIDED|90.0|3.8|11.7|||LDA Model|||LDL-C values after log transformation were analyzed using a constrained LDA model that included terms for treatment, period, the interaction of treatment by period, prior antihyperglycemic therapy status (yes/no), and randomization stratum (participation in domiciled visits \[yes/no\]). Percentage change from baseline in LDL-C after 4-week treatment was reported, after back-transformation using the delta method with an alpha-level of 0.10 (2-sided).||11.7|3.8|0.002
72499205|NCT00868790|144528727|SUPERIORITY_OR_OTHER||LSM Difference|-3.9||||0.248|TWO_SIDED|90.0|-10.2|2.3|||LDA Model|||LDL-C values after log transformation were analyzed using a constrained LDA model that included terms for treatment, period, the interaction of treatment by period, prior antihyperglycemic therapy status (yes/no), and randomization stratum (participation in domiciled visits \[yes/no\]). Percentage change from baseline in LDL-C after 4-week treatment was reported, after back-transformation using the delta method with an alpha-level of 0.10 (2-sided).||2.3|-10.2|0.248
72499206|NCT03377634|144528736|OTHER|Analysis of covariance on change in PROMIS Pain intensity, with group as fixed effect and controlling for baseline pain intensity||||||0.11|||||||ANCOVA|||||||0.11
72499207|NCT03377634|144528737|OTHER|Analysis of covariance on change in PROMIS pain interference, with group as fixed effect and controlling for baseline pain interference||||||0.99|||||||ANCOVA|||||||.99
72499208|NCT03377634|144528738|OTHER|Analysis of covariance on change in SPPB, with group as fixed effect and controlling for baseline SPPB||||||0.14|||||||ANCOVA|||||||.14
72499209|NCT03377634|144528739|OTHER|Analysis of covariance on change in weight, with group as fixed effect and controlling for baseline weight||||||0.11|||||||ANCOVA|||||||.11
72499210|NCT03377634|144528740|OTHER|Analysis of covariance on change in activity time, with group as fixed effect and controlling for baseline stepping time||||||0.65|||||||ANCOVA|||||||.65
72499211|NCT03377634|144528741|OTHER|Analysis of covariance on change in sitting time, with group as fixed effect and controlling for baseline sitting time||||||0.41|||||||ANCOVA|||||||.41
72499212|NCT03377634|144528742|OTHER|Analysis of covariance on change in sit to stand transitions, with group as fixed effect and controlling for baseline transitions||||||0.28|||||||ANCOVA|||||||.28
72499213|NCT01818297|144528768|SUPERIORITY||Risk Difference (RD)|11.5|STANDARD_ERROR_OF_MEAN|10.5||0.14|ONE_SIDED|95.0|-5.8|||Due to early termination, the study was insufficiently powered to test the primary objective. This analysis is exploratory and descriptive in nature and cannot be considered conclusive.|Z-test|The Z-test (using an unpooled standard deviation, without continuity correction) was used to test the difference in responder rates between groups.|The Estimation Parameter is the difference between the responder rates in the Treatment and Control groups. The difference is calculated as Treatment - Control. A positive number represents a higher responder rate in the Treatment group.|The original sample size estimate for the primary objective was based on the following assumptions: 109 subjects in each arm with a responder rate of 22% in the Control group and 40% in the Treatment group, and a one-sided α= 0.05 using a Z test with unpooled variance, would result in 90% power. Because the study terminated early, the actual sample size (32 in Treatment, 30 in Control) resulted in 47% power under the same assumptions.|||-5.8|0.14
72499214|NCT04672083|144528814|OTHER||||||<|0.05|||||||ANOVA|||"CPT31 dose proportionality will be examined across dose groups using a power model approach or ANOVA model, as appropriate.PK parameters will be analyzed using a power model that will have the following form: parameter = intercept × dose\^slope + random error.~Using the natural log (ln) transformation, a power model can be expressed as a linear regression equation: ln(parameter) = intercept + slope × ln(dose) + random error. For dose proportionality, the slope = 1; for dose independence, = 0."||||<0.05
72619958|NCT02205359|144770982|SUPERIORITY||Hazard Ratio (HR)|0.99||||0.89|TWO_SIDED|95.0|0.85|1.16|||Regression, Cox|Stratified by NYHA class and with investigational site as a random effect||||1.16|0.85|0.89
72499215|NCT04672083|144528815|OTHER||||||<|0.05|||||||ANOVA|||"CPT31 dose proportionality will be examined across dose groups using a power model approach or ANOVA model, as appropriate.PK parameters will be analyzed using a power model that will have the following form: parameter = intercept × dose\^slope + random error.~Using the natural log (ln) transformation, a power model can be expressed as a linear regression equation: ln(parameter) = intercept + slope × ln(dose) + random error. For dose proportionality, the slope = 1; for dose independence, = 0."||||<0.05
72499216|NCT04672083|144528816|OTHER||||||<|0.05|||||||Regression, Linear|||The lack of fit test will be conducted for the statistical assessment of linearity assumption (AOL), and thus appropriateness of a power model. PK parameter is dose proportional if AOL is ruled acceptable and the 95% confidence interval for the slope spans 1. If the AOL is ruled unacceptable for any PK parameter, its corresponding PK parameter normalized by dose administered will be ln-transformed and analyzed using an analysis of variance (ANOVA) model. The model will include dose as a factor.||||<0.05
72619959|NCT02205359|144770983|SUPERIORITY||Difference in mean change from baseline|-0.07||||0.88|TWO_SIDED|95.0|-1.03|0.89|||ANCOVA|Stratified by NYHA class and with investigational site as a random effect||||0.89|-1.03|0.88
72619960|NCT02205359|144770984|SUPERIORITY||Difference in mean change from baseline|0.0013||||0.75|TWO_SIDED|95.0|-0.0068|0.0094|||ANCOVA|Stratified by NYHA class and with investigational site as a random effect||||0.0094|-0.0068|0.75
72619961|NCT02205359|144770985|SUPERIORITY||rate ratio|1.15||||0.52|TWO_SIDED|95.0|0.75|1.75|||negative binomial regression|Stratified by NYHA class||||1.75|0.75|0.52
72499217|NCT04672083|144528817|OTHER||||||<|0.05|||||||Regression, Linear|||The lack of fit test will be conducted for the statistical assessment of linearity assumption (AOL), and thus appropriateness of a power model. PK parameter is dose proportional if AOL is ruled acceptable and the 95% CI for the slope spans 1. If the AOL is ruled unacceptable for any PK parameter, its corresponding PK parameter normalized by dose administered will be ln-transformed and analyzed using an analysis of variance (ANOVA) model. The model will include dose as a factor.||||<0.05
72499218|NCT04672083|144528818|OTHER||||||<|0.05|||||||Regression, Linear|||The lack of fit test will be conducted for the statistical assessment of linearity assumption (AOL), and thus appropriateness of a power model. PK parameter is dose proportional if AOL is ruled acceptable and the 95% CI for the slope spans 1. If the AOL is ruled unacceptable for any PK parameter, its corresponding PK parameter normalized by dose administered will be ln-transformed and analyzed using an analysis of variance (ANOVA) model. The model will include dose as a factor.||||<0.05
72499219|NCT04672083|144528819|OTHER||||||<|0.05|||||||Regression, Linear|||The lack of fit test will be conducted for the statistical assessment of linearity assumption (AOL), and thus appropriateness of a power model. PK parameter is dose proportional if AOL is ruled acceptable and the 95% CI for the slope spans 1. If the AOL is ruled unacceptable for any PK parameter, its corresponding PK parameter normalized by dose administered will be ln-transformed and analyzed using an analysis of variance (ANOVA) model. The model will include dose as a factor.||||<0.05
72499220|NCT04672083|144528820|OTHER||||||<|0.05|||||||Regression, Linear|||The lack of fit test will be conducted for the statistical assessment of linearity assumption (AOL), and thus appropriateness of a power model. PK parameter is dose proportional if AOL is ruled acceptable and the 95% CI for the slope spans 1. If the AOL is ruled unacceptable for any PK parameter, its corresponding PK parameter normalized by dose administered will be ln-transformed and analyzed using an analysis of variance (ANOVA) model. The model will include dose as a factor.||||<0.05
72499221|NCT04672083|144528821|OTHER||||||<|0.05|||||||Regression, Linear|||Concentrations for all subjects in Cohorts 1-3 were below the limit of quantification.||||<0.05
72499222|NCT04672083|144528822|OTHER||||||<|0.05|||||||Regression, Linear|||Concentrations for all subjects in Cohorts 1-3 were below the limit of quantitation||||<0.05
72499223|NCT04672083|144528823|OTHER||||||<|0.05|||||||Regression, Linear|||Concentrations for all subjects in Cohorts 1-3 were below the limit of quantitation||||<0.05
72499224|NCT04672083|144528824|OTHER||||||<|0.05|||||||Regression, Linear|||The lack of fit test will be conducted for the statistical assessment of linearity assumption (AOL), and thus appropriateness of a power model. PK parameter is dose proportional if AOL is ruled acceptable and the 95% CI for the slope spans 1. If the AOL is ruled unacceptable for any PK parameter, its corresponding PK parameter normalized by dose administered will be ln-transformed and analyzed using an analysis of variance (ANOVA) model. The model will include dose as a factor.||||<0.05
72499225|NCT04068103|144528859|SUPERIORITY|||||||0.98||||||P value \<= 0.35 moves trial to phase III, \>0.35 stops trial for futility. Decision rule calls for early stopping due to futility.|Fisher Exact|||One-sided Fisher's Exact Test of ctDNA clearance by treatment arm.||||0.98
72562159|NCT00420095|144655659|NON_INFERIORITY_OR_EQUIVALENCE|"Non-inferiority hypothesis testing where paired t-test for equivalence of means was used to estimate the sample size.~Pre-defined non-inferiority margin of 0.3%."|Mean Difference (Net)|-0.05||||0.497||95.0|-0.2|0.1|||Mixed Models Analysis|The Kenward-Roger approximation was used to estimate the denominator degrees of freedom. Adjusted means were presented.||Mixed model where period, sequence, treatment are fixed effects and patient within sequence are random effects.||0.10|-0.20|0.497
72391589|NCT03292588|144290435|SUPERIORITY||Least Square Mean Difference|-0.51||||0.096|TWO_SIDED|95.0|-1.11|0.09|||Mixed Models Analysis|The difference in least square mean of CASI scores for week 36.||Week 36||0.09|-1.11|0.096
72499226|NCT02732951|144528867|OTHER||Adjusted Mean|16.45|STANDARD_ERROR_OF_MEAN|16.45||0.3199|TWO_SIDED|95.0|-16.23|49.13|||Mixed model for repeated measurements|Kenward-Roger approximation was used for denominator degrees of freedom.|Fixed effects of treatment, prior anti-diabetic macular oedema treatment status, visit, treatment by visit interaction, baseline, baseline by visit interaction; patient as a random effect; unstructured covariance matrix for within patient errors.|Null hypothesis = The CSFT change from baseline at Week 12 is equal in both groups||49.13|-16.23|0.3199
72499227|NCT00371267|144528887|SUPERIORITY_OR_OTHER||||||<|0.27|TWO_SIDED||||||Mixed Models Analysis|||||||<0.27
72499228|NCT00371267|144528888|SUPERIORITY_OR_OTHER||||||<|0.35|TWO_SIDED||||||Mixed Models Analysis|||||||<0.35
72499229|NCT00371267|144528889|SUPERIORITY_OR_OTHER||||||<|0.74|TWO_SIDED||||||Mixed Models Analysis|||||||<0.74
72499230|NCT00371267|144528890|SUPERIORITY_OR_OTHER|||||||0.39|TWO_SIDED||||||Mixed Models Analysis|||||||0.39
72499231|NCT00371267|144528891|SUPERIORITY_OR_OTHER|||||||0.67|TWO_SIDED||||||Mixed Models Analysis|||||||0.67
72499232|NCT01575912|144528959|OTHER|||||||0.121||||||using Mann Whitney test|Wilcoxon (Mann-Whitney)|||||||0.121
72499233|NCT00961532|144528964|SUPERIORITY_OR_OTHER|||||||0.014|||||||t-test, 2 sided|||We tested the hypothesis that there would be a change from baseline to 60 minutes after the start of the desmopressin (DDAVP) infusion.||||0.014
72499234|NCT01252966|144528995|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.69||||0.14|TWO_SIDED|95.0|0.42|1.13|||Regression, Logistic|||Longitudinal logistic regression with fitted generalized estimating equations (GEE) was used to estimate an overall treatment effect odds ratio including both the EOT and 6-month time points and relevant covariates (e.g., baseline smoking rate, age, Shipley IQ score). The study (n=213) had 80% power to detect small to medium effects on quit rates (corresponding to Cohen's one-sample d=0.38).||1.13|0.42|0.14
72499235|NCT01252966|144528997|SUPERIORITY_OR_OTHER|||||||0.3|||||||Regression, Linear|||Multiple regression models were used to estimate effects of treatment on change in cognitive performance. Age, Shipley IQ score, number of cigarettes smoked per day at baseline, and EOT smoking status were included as covariates.||||0.30
72562160|NCT00420095|144655660|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.05||||0.497||95.0|-0.1|0.2||All comparisons were conducted using a 2-sided significance level of 0.05.|Mixed Models Analysis|Adjusted means||||0.20|-0.10|0.497
72562161|NCT00420095|144655661|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.14||||0.419||95.0|-0.48|0.2||All comparisons were conducted using a 2-sided significance level of 0.05.|Mixed Models Analysis|Adjusted means||||0.20|-0.48|0.419
72562162|NCT00420095|144655662|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.16||||0.741||95.0|-1.09|0.78||All comparisons were conducted using a 2-sided significance level of 0.05.|Mixed Models Analysis|Adjusted means||||0.78|-1.09|0.741
72452125|NCT03500549|144426920|NON_INFERIORITY|Analysis was based on prespecified NIM and non-inferiority was achieved if the lower confidence limit or upper confidence limit of the 95% CI of the treatment difference met the prespecified NIM of 10.|LS mean difference|-163.61|||<|0.0001|TWO_SIDED|95.0|-189.91|-137.3||Non-inferiority was tested at the 2.5% level. MMRM includes treatment + baseline value + analysis visit + strata + analysis visit × treatment, where strata is the combination of randomization stratification factors.|MMRM|||||-137.30|-189.91|<0.0001
72452126|NCT03500549|144426921|NON_INFERIORITY|Analysis was based on prespecified NIM and non-inferiority was achieved if the lower confidence limit or upper confidence limit of the 95% CI of the treatment difference met the prespecified NIM of 20.|LS mean difference|-4.63||||0.9557|TWO_SIDED|95.0|-181.3|172.04||Non-inferiority was tested at the 2.5% level. MMRM includes treatment + baseline value + analysis visit + strata + analysis visit × treatment, where strata is the combination of randomization stratification factors.|MMRM|||||172.04|-181.30|0.9557
72452127|NCT03500549|144426922|OTHER|Non-inferiority was not assessed because of the prespecified hierarchical testing. Analysis was a between-treatment-group comparison using an MMRM. The difference between pegcetacoplan and eculizumab LS mean changes from Baseline at Week 16 was calculated along with its 2-sided 95% CI and associated P-value from the MMRM model for the ITT set, censored for transfusions.|LS mean difference|11.87||||0.0005|TWO_SIDED|95.0|5.49|18.25||MRMM includes treatment + baseline value + analysis visit + strata + analysis visit × treatment, where strata is the combination of randomization stratification factors.|MMRM|||||18.25|5.49|0.0005
72452128|NCT03500549|144426923|OTHER|Stratified CMH chi-square test was used for treatment comparison and the 95% CI for difference in percentage between treatments is constructed using the stratified Miettinen-Nurminen method.|Difference in percentage|0.6745|||||TWO_SIDED|95.0|0.5452|0.8039|||||The difference in percentage and 95% CI is calculated based on stratified Miettinen-Nurminen method stratified by randomization factor so it it is not a direct difference of two reporting groups.|||0.8039|0.5452|
72452129|NCT03500549|144426924|OTHER|Stratified CMH chi-square test was used for treatment comparison and the 95% CI for difference in percentage between treatments is constructed using the stratified Miettinen-Nurminen method.|Difference in percentage|0.6639|||||TWO_SIDED|95.0|0.5309|0.7968|||||The difference in percentage and 95% CI is calculated based on stratified Miettinen-Nurminen method stratified by randomization factor so it it is not a direct difference of two reporting groups.|||0.7968|0.5309|
72452130|NCT03500549|144426925|OTHER|Stratified CMH chi-square test was used for treatment comparison and the 95% CI for difference in percentage between treatments is constructed using the stratified Miettinen-Nurminen method.|Difference in percentage|0.3043|||||TWO_SIDED|95.0|0.1493|0.4593|||||The difference in percentage and 95% CI is calculated based on stratified Miettinen-Nurminen method stratified by randomization factor so it it is not a direct difference of two reporting groups.|||0.4593|0.1493|
72452131|NCT03500549|144426926|OTHER|Analysis was a between-treatment-group comparison using an MMRM. The difference between pegcetacoplan and eculizumab LS mean changes from Baseline at Week 16 was calculated along with its 2-sided 95% CI and associated P-value from the MMRM model for the ITT set, censored for transfusions.|LS mean difference|-21.93||||0.0002|TWO_SIDED|95.0|-32.49|-11.36||MMRM includes treatment + baseline value + analysis visit + strata + analysis visit × treatment, where strata is the combination of randomization stratification factors.|MMRM|||||-11.36|-32.49|0.0002
72452132|NCT03500549|144426927|OTHER|Analysis was a between-treatment-group comparison using an MMRM. The difference between pegcetacoplan and eculizumab LS mean changes from Baseline at Week 16 was calculated along with its 2-sided 95% CI and associated P-value from the MMRM model for the ITT set, censored for transfusions.|LS mean difference|-0.14||||0.0369|TWO_SIDED|95.0|-0.28|-0.01||MMRM includes treatment + baseline value + analysis visit + strata + analysis visit × treatment, where strata is the combination of randomization stratification factors.|MMRM|||||-0.01|-0.28|0.0369
72452133|NCT03500549|144426928|OTHER|Analysis was a between-treatment-group comparison using an MMRM. The difference between pegcetacoplan and eculizumab LS mean changes from Baseline at Week 16 was calculated along with its 2-sided 95% CI and associated P-value from the MMRM model for the ITT set, censored for transfusions.|LS mean difference|59.1||||0.0069|TWO_SIDED|95.0|16.88|101.32||MMRM includes treatment + baseline value + analysis visit + strata + analysis visit × treatment, where strata is the combination of randomization stratification factors.|MMRM|||||101.32|16.88|0.0069
72452134|NCT03500549|144426929|OTHER|Analysis was a between-treatment-group comparison using an MMRM. The difference between pegcetacoplan and eculizumab LS mean changes from Baseline at Week 16 was calculated along with its 2-sided 95% CI and associated P-value from the MMRM model for the ITT set, censored for transfusions.|LS mean difference|18.62||||0.0486|TWO_SIDED|95.0|0.12|37.13||MMRM includes treatment + baseline value + analysis visit + strata + analysis visit × treatment, where strata is the combination of randomization stratification factors.|MMRM|||Global Health Status/QoL: Difference in LS mean||37.13|0.12|0.0486
72452135|NCT03500549|144426929|OTHER|Analysis was a between-treatment-group comparison using an MMRM. The difference between pegcetacoplan and eculizumab LS mean changes from Baseline at Week 16 was calculated along with its 2-sided 95% CI and associated P-value from the MMRM model for the ITT set, censored for transfusions.|LS mean difference|12.86||||0.0023|TWO_SIDED|95.0|4.86|20.86||MMRM includes treatment + baseline value + analysis visit + strata + analysis visit × treatment, where strata is the combination of randomization stratification factors.|MMRM|||Functional Scales - Physical functioning: Difference in LS mean||20.86|4.86|0.0023
72562163|NCT00420095|144655663|SUPERIORITY_OR_OTHER|||||||0.644||95.0||||P-value for the HbA1c Percentage Criteria (7%)|Fisher Exact|||||||0.644
72562164|NCT00420095|144655663|SUPERIORITY_OR_OTHER|||||||0.672||95.0||||P-value for the HbA1c Percentage Criteria (6.5%)|Fisher Exact|||||||0.672
72562165|NCT00420095|144655665|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.03||||0.67||95.0|-0.16|0.11||All comparisons were conducted using a 2-sided significance level of 0.05.|Mixed Models Analysis|Adjusted means||||0.11|-0.16|0.670
72562166|NCT00393705|144655666|SUPERIORITY_OR_OTHER|||||||0.2519||95.0|||||ANCOVA|Model: Value = Treatment + Lead-in + Treatment\*Lead-in + Visit + Treatment\*Visit + Value at baseline + error.||||||0.2519
72562167|NCT00393705|144655667|SUPERIORITY_OR_OTHER|||||||0.0287||95.0||||P-value for HbA1c \<7%. Additional statistically significant terms from the model below were baseline HbA1c and treatment by lead-in interaction.|Regression, Logistic|Model: Logit(p(response)/1-p(response)) = U + r' X, where u = intercept parameter, X = vector of parameters (treatment, baseline value, lead-in).||||||0.0287
72391590|NCT03292588|144290435|SUPERIORITY||Least Square Mean Difference|-0.06||||0.831|TWO_SIDED|95.0|-0.65|0.52|||Mixed Models Analysis|The difference in least square mean of CASI scores for week 48.||Week 48||0.52|-0.65|0.831
72391591|NCT03292588|144290435|SUPERIORITY||Least Square Mean Difference|0.02||||0.947|TWO_SIDED|95.0|-0.6|0.64|||Mixed Models Analysis|The difference in least square mean of CASI scores for week 52.||Week 52||0.64|-0.60|0.947
72391592|NCT03292588|144290436|SUPERIORITY|A generalized logit model was used to analyze Physician Global Assessment Tool at Visit 14. The model included treatment arm as fixed effect as primary exposure but was also adjusted for study site, # of exacerbations in year prior to study (2 or 3+), peripheral blood eosinophils ((\< or ≥400 cells/μl), BMI (\< or ≥95th percentile for age) \& total serum IgE (\< or ≥540 kUA/L). No imputation of missing data was used for participants who weren't assessed for quality of life measurements at Visit 14.|Odds Ratio (OR)|1.01||||0.974|TWO_SIDED|95.0|0.62|1.64|||Regression, Logistic|||Physician Global Assessment Tool||1.64|0.62|0.974
72391593|NCT03292588|144290437|SUPERIORITY|A generalized logit model was used to analyze the Patient Global Assessment Tool at Visit 14. The model included treatment arm as fixed effect as the primary exposure but was adjusted for study site, # of exacerbations in year prior to study (2 or 3+), peripheral blood eosinophils ((\< or ≥400 cells/μl), BMI (\< or ≥95th percentile for age) \& total serum IgE (\< or ≥540 kUA/L). No imputation of missing data was used for participants who weren't assessed for quality of life measurements at Visit 14.|Odds Ratio (OR)|0.72||||0.238|TWO_SIDED|95.0|0.42|1.24|||Regression, Logistic|||Patient Global Assessment Tool||1.24|0.42|0.238
72391594|NCT03292588|144290438|SUPERIORITY|A generalized mixed model as described in section 8.3.1 was used to analyze each spirometry and impulse oscillometry parameter, separately, at each visit where the lung function was collected.|Least Square Mean Difference|-0.005||||0.591|TWO_SIDED|95.0|-0.023|0.013|||Mixed Models Analysis|||FEV1/FVC Week 12||0.013|-0.023|0.591
72391595|NCT03292588|144290438|SUPERIORITY||Least Square Mean Difference|-0.011||||0.265|TWO_SIDED|95.0|-0.031|0.008|||Mixed Models Analysis|||FEV1/FVC Week 24||0.008|-0.031|0.265
72391596|NCT03292588|144290438|SUPERIORITY||Least Square Mean Difference|0.011||||0.345|TWO_SIDED|95.0|-0.012|0.033|||Mixed Models Analysis|||FEV1/FVC Week 36||0.033|-0.012|0.345
72452136|NCT03500549|144426929|OTHER|Analysis was a between-treatment-group comparison using an MMRM. The difference between pegcetacoplan and eculizumab LS mean changes from Baseline at Week 16 was calculated along with its 2-sided 95% CI and associated P-value from the MMRM model for the ITT set, censored for transfusions.|LS mean difference|24.43||||0.0027|TWO_SIDED|95.0|8.84|40.01||MMRM includes treatment + baseline value + analysis visit + strata + analysis visit × treatment, where strata is the combination of randomization stratification factors.|MMRM|||Functional Scales - Role functioning: Difference in LS mean||40.01|8.84|0.0027
72452137|NCT03500549|144426929|OTHER|Analysis was a between-treatment-group comparison using an MMRM. The difference between pegcetacoplan and eculizumab LS mean changes from Baseline at Week 16 was calculated along with its 2-sided 95% CI and associated P-value from the MMRM model for the ITT set, censored for transfusions.|LS mean difference|4.11||||0.6013|TWO_SIDED|95.0|-11.58|19.8||MMRM includes treatment + baseline value + analysis visit + strata + analysis visit × treatment, where strata is the combination of randomization stratification factors.|MMRM|||Functional Scales - Emotional functioning: Difference in LS mean||19.80|-11.58|0.6013
72452138|NCT03500549|144426929|OTHER|Analysis was a between-treatment-group comparison using an MMRM. The difference between pegcetacoplan and eculizumab LS mean changes from Baseline at Week 16 was calculated along with its 2-sided 95% CI and associated P-value from the MMRM model for the ITT set, censored for transfusions.|LS mean difference|9.56||||0.1792|TWO_SIDED|95.0|-4.52|23.64||MMRM includes treatment + baseline value + analysis visit + strata + analysis visit × treatment, where strata is the combination of randomization stratification factors.|MMRM|||Functional Scales - Cognitive functioning: Difference in LS mean||23.64|-4.52|0.1792
72452139|NCT03500549|144426929|OTHER|Analysis was a between-treatment-group comparison using an MMRM. The difference between pegcetacoplan and eculizumab LS mean changes from Baseline at Week 16 was calculated along with its 2-sided 95% CI and associated P-value from the MMRM model for the ITT set, censored for transfusions.|LS mean difference|11.27||||0.1039|TWO_SIDED|95.0|-2.38|24.92||MMRM includes treatment + baseline value + analysis visit + strata + analysis visit × treatment, where strata is the combination of randomization stratification factors.|MMRM|||Functional Scales - Social functioning: Difference in LS mean||24.92|-2.38|0.1039
72499236|NCT01252966|144528998|SUPERIORITY_OR_OTHER|||||||0.3|||||||Regression, Linear|||Multiple regression models were used to estimate effects of treatment on change in cognitive performance. Age, Shipley IQ score, number of cigarettes smoked per day at baseline, and EOT smoking status were included as covariates.||||0.30
72391597|NCT03292588|144290438|SUPERIORITY||Least Square Mean Difference|0.013||||0.248|TWO_SIDED|95.0|-0.009|0.036|||Mixed Models Analysis|||FEV1/FVC Week 48||0.036|-0.009|0.248
72391598|NCT03292588|144290438|SUPERIORITY||Least Square Mean Difference|-0.002||||0.864|TWO_SIDED|95.0|-0.023|0.02|||Mixed Models Analysis|||FEV1/FVC Week 52||0.020|-0.023|0.864
72391599|NCT03292588|144290439|SUPERIORITY||Least Square Mean Difference|-0.4||||0.816|TWO_SIDED|95.0|-3.8|3.0|||Mixed Models Analysis|||FEV1PP Week 12||3.0|-3.8|0.816
72391600|NCT03292588|144290439|SUPERIORITY||Least Square Mean Difference|-3.4||||0.095|TWO_SIDED|95.0|-7.4|0.6|||Mixed Models Analysis|||FEV1PP Week 24||0.6|-7.4|0.095
72391601|NCT03292588|144290439|SUPERIORITY||Least Square Mean Difference|1.5||||0.444|TWO_SIDED|95.0|-2.4|5.5|||Mixed Models Analysis|||FEV1PP Week 36||5.5|-2.4|0.444
72391602|NCT03292588|144290439|SUPERIORITY||Least Square Mean Difference|0.6||||0.751|TWO_SIDED|95.0|-3.3|4.6|||Mixed Models Analysis|||FEV1PP Week 48||4.6|-3.3|0.751
72391603|NCT03292588|144290439|SUPERIORITY||Least Square Mean Difference|-2.6||||0.184|TWO_SIDED|95.0|-6.5|1.3|||Mixed Models Analysis|||FEV1PP Week 52||1.3|-6.5|0.184
72391604|NCT03292588|144290440|SUPERIORITY|Negative binomial model for the rate of exacerbations (per year. The model included an offset term to account for differential follow-up among participants. To account for adaptive randomization, the model was also adjusted for study site, number of exacerbations in year prior to study (2 or 3+), peripheral blood eosinophils (\< or ≥400 cells/μl), BMI (\< or ≥95th percentile for age), total serum IgE (\< or ≥540 kUA/L) and treatment dose (40 mg or 100 mg).|Risk Ratio (RR)|0.85||||0.458|TWO_SIDED|95.0|0.55|1.31|||Mixed Models Analysis|||Did not meet FDA-approved dosing||1.31|0.55|0.458
72452140|NCT03500549|144426929|OTHER|Analysis was a between-treatment-group comparison using an MMRM. The difference between pegcetacoplan and eculizumab LS mean changes from Baseline at Week 16 was calculated along with its 2-sided 95% CI and associated P-value from the MMRM model for the ITT set, censored for transfusions.|LS mean difference|-20.74||||0.0062|TWO_SIDED|95.0|-35.29|-6.19||MMRM includes treatment + baseline value + analysis visit + strata + analysis visit × treatment, where strata is the combination of randomization stratification factors.|MMRM|||Symptom Scales - Fatigue: Difference in LS mean||-6.19|-35.29|0.0062
72452141|NCT03500549|144426929|OTHER|Analysis was a between-treatment-group comparison using an MMRM. The difference between pegcetacoplan and eculizumab LS mean changes from Baseline at Week 16 was calculated along with its 2-sided 95% CI and associated P-value from the MMRM model for the ITT set, censored for transfusions.|LS mean difference|-0.01||||0.9975|TWO_SIDED|95.0|-8.38|8.35||MMRM includes treatment + baseline value + analysis visit + strata + analysis visit × treatment, where strata is the combination of randomization stratification factors.|MMRM|||Symptom Scales - Nausea and vomiting: Difference in LS mean||8.35|-8.38|0.9975
72452142|NCT03500549|144426929|OTHER|Analysis was a between-treatment-group comparison using an MMRM. The difference between pegcetacoplan and eculizumab LS mean changes from Baseline at Week 16 was calculated along with its 2-sided 95% CI and associated P-value from the MMRM model for the ITT set, censored for transfusions.|LS mean difference|-2.76||||0.7554|TWO_SIDED|95.0|-20.36|14.85||MMRM includes treatment + baseline value + analysis visit + strata + analysis visit × treatment, where strata is the combination of randomization stratification factors.|MMRM|||Symptom Scales - Pain: Difference in LS mean||14.85|-20.36|0.7554
72452143|NCT03500549|144426929|OTHER|Analysis was a between-treatment-group comparison using an MMRM. The difference between pegcetacoplan and eculizumab LS mean changes from Baseline at Week 16 was calculated along with its 2-sided 95% CI and associated P-value from the MMRM model for the ITT set, censored for transfusions.|LS mean difference|-14.57||||0.062|TWO_SIDED|95.0|-29.9|0.76||MMRM includes treatment + baseline value + analysis visit + strata + analysis visit × treatment, where strata is the combination of randomization stratification factors.|MMRM|||Symptom Scales - Dyspnoea: Difference in LS mean||0.76|-29.90|0.0620
72452144|NCT03500549|144426929|OTHER|Analysis was a between-treatment-group comparison using an MMRM. The difference between pegcetacoplan and eculizumab LS mean changes from Baseline at Week 16 was calculated along with its 2-sided 95% CI and associated P-value from the MMRM model for the ITT set, censored for transfusions.|LS mean difference|0.32||||0.9686|TWO_SIDED|95.0|-15.67|16.3||MMRM includes treatment + baseline value + analysis visit + strata + analysis visit × treatment, where strata is the combination of randomization stratification factors.|MMRM|||Symptom Scales - Insomnia: Difference in LS mean||16.30|-15.67|0.9686
72452145|NCT03500549|144426929|OTHER|Analysis was a between-treatment-group comparison using an MMRM. The difference between pegcetacoplan and eculizumab LS mean changes from Baseline at Week 16 was calculated along with its 2-sided 95% CI and associated P-value from the MMRM model for the ITT set, censored for transfusions.|LS mean difference|-7.95||||0.3002|TWO_SIDED|95.0|-23.23|7.33||MMRM includes treatment + baseline value + analysis visit + strata + analysis visit × treatment, where strata is the combination of randomization stratification factors.|MMRM|||Symptom Scales - Appetite loss: Difference in LS mean||7.33|-23.23|0.3002
72499237|NCT01252966|144528999|SUPERIORITY_OR_OTHER|||||||0.033||||||Results would not survive correction for multiple hypothesis testing.|Regression, Linear|||Multiple regression models were used to estimate effects of treatment on change in cognitive performance. Age, Shipley IQ score, number of cigarettes smoked per day at baseline, and EOT smoking status were included as covariates.||||0.033
72499238|NCT03275870|144529009|OTHER|||||||0.042||||||p value \<0.05 used as threshold for significance|t-test, 2 sided|||||||0.042
72499239|NCT03275870|144529010|OTHER|||||||0.213||||||P value of \<0.05 used as threshold for significance|t-test, 2 sided|||||||0.213
72499240|NCT02240134|144529016|SUPERIORITY||Odds Ratio (OR)|1.23||||0.68|TWO_SIDED|95.0|0.46|3.32|||Mixed Models Analysis||Odds ratio for air filter treatment relative to placebo|Mixed effects logistic regression model with presence of LRTI as outcome (yes or no); assigned treatment as primary exposure variable relative to placebo; adjusted for child age and person-time at-risk; nested random term: home:cohort:area. Results presented as odds ratios with 95% Confidence Intervals.||3.32|0.46|0.68
72499241|NCT02240134|144529016|SUPERIORITY||Odds Ratio (OR)|0.98||||0.96|TWO_SIDED|95.0|0.35|2.72|||Mixed Models Analysis||Odds ratio for filter treatment relative to placebo|Mixed effects logistic regression model with presence of LRTI as outcome (yes or no); assigned treatment as primary exposure variable relative to placebo; adjusted for child age and person-time at-risk; nested random term: home:cohort:area. Results presented as odds ratios with 95% Confidence Intervals.||2.72|0.35|0.96
72562168|NCT00393705|144655667|SUPERIORITY_OR_OTHER|||||||0.0471||95.0||||P-value for HbA1c ≤6.5%. Additional statistically significant term from the model below was baseline HbA1c.|Regression, Logistic|Model: Logit(p(response)/1-p(response)) = U + r' X, where u = intercept parameter, X = vector of parameters (treatment, baseline value, lead-in).||||||0.0471
72562169|NCT00393705|144655669|SUPERIORITY_OR_OTHER|||||||0.0077||95.0|||||ANCOVA|Model: Value = Treatment + Lead-in + Treatment\*Lead-in + Visit + Treatment\*Visit + Value at baseline + error.||||||0.0077
72562170|NCT00393705|144655670|SUPERIORITY_OR_OTHER|||||||0.0002||95.0|||||ANCOVA|Model: Value = Treatment + Lead-in + Treatment\*Lead-in + Visit + Treatment\*Visit + Value at baseline + error.||||||0.0002
72452146|NCT03500549|144426929|OTHER|Analysis was a between-treatment-group comparison using an MMRM. The difference between pegcetacoplan and eculizumab LS mean changes from Baseline at Week 16 was calculated along with its 2-sided 95% CI and associated P-value from the MMRM model for the ITT set, censored for transfusions.|LS mean difference|1.79||||0.8374|TWO_SIDED|95.0|-15.7|19.29||MMRM includes treatment + baseline value + analysis visit + strata + analysis visit × treatment, where strata is the combination of randomization stratification factors.|MMRM|||Symptom Scales - Constipation: Difference in LS mean||19.29|-15.70|0.8374
72499242|NCT02240134|144529017|SUPERIORITY||percent differences in geometric mean PM|-6.96||||0.25|TWO_SIDED|95.0|-30.5|24.55|||Mixed Models Analysis|||Linear mixed model with natural-log transformed 6-day mean indoor PM2.5 as outcome; assigned treatment as primary exposure variable; adjusted for child age; nested random term: cohort:area. Results presented as effect estimates with 95% Confidence Intervals and reported as percent differences in geometric mean PM2.5.||24.55|-30.50|0.250
72499243|NCT02240134|144529017|SUPERIORITY||percent differences in geometric mean PM|11.77||||0.295|TWO_SIDED|95.0|-16.57|49.72||Statistical significance selected as 95% confidence interval of the estimation parameter that excludes the null value, 0.|Mixed Models Analysis||Difference in indoor PM2.5 for education treatment versus placebo.|Linear mixed model with natural-log transformed 6-day mean indoor PM2.5 as outcome; assigned treatment as primary exposure variable; adjusted for child age; nested random term: cohort:area. Results presented as effect estimates with 95% Confidence Intervals and reported as percent differences in geometric mean PM2.5.||49.72|-16.57|0.295
72499244|NCT00206726|144529018|SUPERIORITY_OR_OTHER||CR rate|0.0833||||0.014||90.0|0.0334|0.1673||2-sided p-value computed from an exact binomial test comparing the observed rate versus 2% historical rate|exact binomial test|||Comparison of CR rate versus 2 percent (%) historic control (p-value and 90% confidence interval)||0.1673|0.0334|0.014
72499245|NCT00450580|144529058|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority can be concluded if the lower bound of a two-sided 95% confidence interval for the difference in response rates between the two treatment arms is greater than -12%.|Risk Difference (RD)|-0.9||||||95.0|-11.4|9.5||||||||9.5|-11.4|
72504807|NCT03114969|144540516|SUPERIORITY||Odds Ratio (OR)|5.268||||0.006|TWO_SIDED|95.0|1.615|17.187||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Incruse/Anoro Ellipta as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.|||17.187|1.615|0.006
72562171|NCT00393705|144655671|SUPERIORITY_OR_OTHER|||||||0.0129||95.0||||P-value for Fasting.|ANCOVA|Model: Value = Treatment + Lead-in + Treatment\*Lead-in + Visit + Treatment\*Visit + Value at baseline + error.||||||0.0129
72562172|NCT00393705|144655671|SUPERIORITY_OR_OTHER|||||||0.0027||95.0||||P-value for 2-Hours After Breakfast.|ANCOVA|Model: Value = Treatment + Lead-in + Treatment\*Lead-in + Visit + Treatment\*Visit + Value at baseline + error.||||||0.0027
72562173|NCT00393705|144655671|SUPERIORITY_OR_OTHER|||||||0.1947||95.0||||P-value for Pre-Lunch.|ANCOVA|Model: Value = Treatment + Lead-in + Treatment\*Lead-in + Visit + Treatment\*Visit + Value at baseline + error.||||||0.1947
72562174|NCT00393705|144655671|SUPERIORITY_OR_OTHER|||||||0.0077||95.0||||P-value for 2-Hours After Lunch.|ANCOVA|Model: Value = Treatment + Lead-in + Treatment\*Lead-in + Visit + Treatment\*Visit + Value at baseline + error.||||||0.0077
72562175|NCT00393705|144655671|SUPERIORITY_OR_OTHER|||||||0.1885||95.0||||P-value for Pre-Dinner.|ANCOVA|Model: Value = Treatment + Lead-in + Treatment\*Lead-in + Visit + Treatment\*Visit + Value at baseline + error.||||||0.1885
72504808|NCT03114969|144540516|SUPERIORITY||Odds Ratio (OR)|4.655||||0.009|TWO_SIDED|95.0|1.478|14.666||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Incruse/Anoro Ellipta as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.|||14.666|1.478|0.009
72562176|NCT00393705|144655671|SUPERIORITY_OR_OTHER|||||||0.5525||95.0||||P-value for 2-Hours After Dinner.|ANCOVA|Model: Value = Treatment + Lead-in + Treatment\*Lead-in + Visit + Treatment\*Visit + Value at baseline + error.||||||0.5525
72562177|NCT00393705|144655671|SUPERIORITY_OR_OTHER|||||||0.4994||95.0||||P-value for 3:00 A.M.|ANCOVA|Model: Value = Treatment + Lead-in + Treatment\*Lead-in + Visit + Treatment\*Visit + Value at baseline + error.||||||0.4994
72562178|NCT00393705|144655673|SUPERIORITY_OR_OTHER|||||||0.723||95.0||||P-value for Total Hypoglycemic Episodes/30 Days.|ANCOVA|Model: Value = Treatment + Lead-in + Treatment\*Lead-in + Visit + Treatment\*Visit + Value at baseline + error.||||||0.7230
72562179|NCT00393705|144655673|SUPERIORITY_OR_OTHER|||||||0.0063||95.0||||P-value for Nocturnal Hypoglycemic Episodes/30 Days.|ANCOVA|Model: Value = Treatment + Lead-in + Treatment\*Lead-in + Visit + Treatment\*Visit + Value at baseline + error.||||||0.0063
72562180|NCT00393705|144655673|SUPERIORITY_OR_OTHER|||||||0.8876||95.0||||P-value for Severe Hypoglycemic Episodes/30 Days.|ANCOVA|Model: Value = Treatment + Lead-in + Treatment\*Lead-in + Visit + Treatment\*Visit + Value at baseline + error.||||||0.8876
72499246|NCT00393718|144529066|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority criterion: Upper limit of confidence interval of mean difference(= Liraglutide - Glibenclamide) is less than 0.4%. Superiority criterion: Upper limit of confidence interval of mean difference(= Liraglutide - Glibenclamide) is less than 0.0%.|Least Squares Mean|-0.5|||<|0.0001||95.0|-0.7|-0.3||p-value is for the null hypothesis for superiority. A significance level of a one-sided 2.5% was used for statistical hypothesis testing.|ANOVA|||"ANOVA model included HbA1C at baseline as a covariate and treatment group and pre-trial treatment as fixed effects.~Hypothesis for non-inferiority:~H0: μ0.9 - μG ≥ 0.4, H1: μ0.9 - μG \< 0.4,~Hypothesis for superiority:~H0: μ0.9 - μG ≥ 0.0, H1: μ0.9 - μG \< 0.0, where μ0.9 and μG are population mean after 24-week treatment for liraglutide 0.9 mg/day and glibenclamide, respectively. When non-inferiority was confirmed, superiority was evaluated based on the closed testing procedure."||-0.30|-0.70|<0.0001
72499247|NCT00393718|144529067|SUPERIORITY_OR_OTHER||Least Squares Mean|-0.49||||||95.0|-0.71|-0.27|||ANOVA|||95% confidence interval for the mean difference (liraglutide - glibenclamide) was calculated under an ANOVA model with treatment group and pre-trial treatment as fixed effects and corresponding baseline value as a covariate, and no statistical testing was performed.||-0.27|-0.71|
72562181|NCT00393705|144655674|SUPERIORITY_OR_OTHER|||||||0.0009||95.0|||||ANCOVA|Model: Value = Treatment + Lead-in + Treatment\*Lead-in + Visit + Treatment\*Visit + Value at baseline + error.||||||0.0009
72499248|NCT00393718|144529068|SUPERIORITY_OR_OTHER||Least Squares Mean|-12.9|||<|0.0001||95.0|-18.2|-7.5||A significance level of a two-sided 5% was used for statistical hypothesis testing.|ANOVA|||The analysis was performed based on an ANOVA model with treatment group and pre-trial treatment as fixed effects and corresponding baseline value as a covariate. The following null hypothesis (H0) was statistically tested against the alternative hypothesis (H1). H0: μ0.9 = μG, H1: μ0.9 ≠ μG where μ0.9 and μG are population mean after 24-week treatment for liraglutide 0.9 mg/day and glibenclamide, respectively.||-7.5|-18.2|<0.0001
72499249|NCT00393718|144529069|SUPERIORITY_OR_OTHER||Least Squares Mean|-11.7||||||95.0|-18.6|-4.9|||ANOVA|||95% confidence interval for the mean difference (liraglutide - glibenclamide) was calculated under an ANOVA model with treatment group and pre-trial treatment as fixed effects and corresponding baseline value as a covariate, and no statistical testing was performed.||-4.9|-18.6|
72499250|NCT00393718|144529070|SUPERIORITY_OR_OTHER||Least Squares Mean|-93.05|||<|0.0001||95.0|-119.61|-66.5||A significance level of a two-sided 5% was used for statistical hypothesis testing.|ANOVA|||The analysis was performed based on an ANOVA model with treatment group and pre-trial treatment as fixed effects and corresponding baseline value as a covariate. The following null hypothesis (H0) was statistically tested against the alternative hypothesis (H1). H0: μ0.9 = μG, H1: μ0.9 ≠ μG where μ0.9 and μG are population mean after 24-week treatment for liraglutide 0.9 mg/day and glibenclamide, respectively.||-66.50|-119.61|<0.0001
72499251|NCT00393718|144529071|SUPERIORITY_OR_OTHER||Least Squares Mean|-74.51||||||95.0|-105.75|-43.27|||ANOVA|||95% confidence interval for the mean difference (liraglutide - glibenclamide) was calculated under an ANOVA model with treatment group and pre-trial treatment as fixed effects and corresponding baseline value as a covariate, and no statistical testing was performed.||-43.27|-105.75|
72499252|NCT00393718|144529072|SUPERIORITY_OR_OTHER||Least Squares Mean|-17.63|||<|0.0001||95.0|-25.0|-10.27||A significance level of a two-sided 5% was used for statistical hypothesis testing.|ANOVA|||The analysis was performed based on an ANOVA model with treatment group and pre-trial treatment as fixed effects and corresponding baseline value as a covariate. The following null hypothesis (H0) was statistically tested against the alternative hypothesis (H1). H0: μ0.9 = μG, H1: μ0.9 ≠ μG where μ0.9 and μG are population mean after 24-week treatment for liraglutide 0.9 mg/day and glibenclamide, respectively.||-10.27|-25.00|<0.0001
72499253|NCT00393718|144529073|SUPERIORITY_OR_OTHER||Least Squares Mean|-17.21||||||95.0|-26.32|-8.09|||ANOVA|||95% confidence interval for the mean difference (liraglutide - glibenclamide) was calculated under an ANOVA model with treatment group and pre-trial treatment as fixed effects and corresponding baseline value as a covariate, and no statistical testing was performed.||-8.09|-26.32|
72562182|NCT00393705|144655675|SUPERIORITY_OR_OTHER|||||||0.0056||95.0||||P-value for Week 4|ANCOVA|Model: Value = Treatment + Lead-in + Treatment\*Lead-in + Visit + Treatment\*Visit + Value at baseline + error.||||||0.0056
72562183|NCT00393705|144655675|SUPERIORITY_OR_OTHER|||||||0.0421||95.0||||P-value for Week 12|ANCOVA|Model: Value = Treatment + Lead-in + Treatment\*Lead-in + Visit + Treatment\*Visit + Value at baseline + error.||||||0.0421
72562184|NCT01475487|144655689|NON_INFERIORITY_OR_EQUIVALENCE|A sample size of 21 participants per group was required to detect a 40% absolute difference in the complication rate between DP and US guided techniques assuming a 45% complication rate in the DP (control) group and using the Fisher's exact test for the comparison of independent proportions. A total of 23 and 24 participants were recruited in the DP and US group, respectively.|||||<|0.01|TWO_SIDED||||||Fisher Exact|||||||<0.01
72562185|NCT01475487|144655690|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|2.88||||0.001|TWO_SIDED|95.0|1.39|5.94|||Fisher Exact||Risk of injury ( none-mild vs moderate -severe) for all participants|||5.94|1.39|0.001
72562186|NCT01475487|144655690|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Fisher Exact|||Grade 3-4 comparison of None-mild and moderate-severe||||<0.001
72562187|NCT01475487|144655691|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.91||||0.701|TWO_SIDED|95.0|0.12|2.72|||Fisher Exact||This is the risk ratio for 1 vs 2 attempts|||2.72|0.12|0.701
72562188|NCT01475487|144655692|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|5.6||||0.043|TWO_SIDED|95.0|0.79|39.48|||Fisher Exact|||Comparison for Grade 3-4||39.48|0.79|0.043
72452147|NCT03500549|144426929|OTHER|Analysis was a between-treatment-group comparison using an MMRM. The difference between pegcetacoplan and eculizumab LS mean changes from Baseline at Week 16 was calculated along with its 2-sided 95% CI and associated P-value from the MMRM model for the ITT set, censored for transfusions.|LS mean difference|-1.38||||0.8775|TWO_SIDED|95.0|-19.28|16.52||MMRM includes treatment + baseline value + analysis visit + strata + analysis visit × treatment, where strata is the combination of randomization stratification factors.|MMRM|||Symptom Scales - Diarrhoea: Difference in LS mean||16.52|-19.28|0.8775
72452148|NCT03500549|144426929|OTHER|Analysis was a between-treatment-group comparison using an MMRM. The difference between pegcetacoplan and eculizumab LS mean changes from Baseline at Week 16 was calculated along with its 2-sided 95% CI and associated P-value from the MMRM model for the ITT set, censored for transfusions.|LS mean difference|-7.4||||0.3066|TWO_SIDED|95.0|-21.76|6.95||MMRM includes treatment + baseline value + analysis visit + strata + analysis visit × treatment, where strata is the combination of randomization stratification factors.|MMRM|||Symptom Scales - Financial difficulties: Difference in LS mean||6.95|-21.76|0.3066
72452149|NCT03500549|144426930|OTHER|Wilcoxon rank-sum test P-value for the comparison between treatments is based on median using stratified non-parametric analysis. The 95% CI is constructed using Hodges-Lehmann Estimation of Location Shift.|Median Difference (Final Values)|3.0|||<|0.0001|TWO_SIDED|95.0|2.0|4.0|||Wilcoxon rank-sum test|||||4.0|2.0|<0.0001
72452150|NCT03593356|144426976|SUPERIORITY||Slope|-0.427|STANDARD_ERROR_OF_MEAN|1.179||0.717|TWO_SIDED|||||We use OLS regression with site fixed effects and baseline covariates. We report unadjusted p-values.|Regression, Linear||Positive (negative) estimates indicate the high cash gift group had a higher (lower) mean than the low cash gift group. Our measure of dispersion of parameter estimates is the standard error of estimate as described in our analysis plan.|||||0.717
72452151|NCT03593356|144426979|SUPERIORITY||Slope|-0.012|STANDARD_ERROR_OF_MEAN|0.043||0.784|TWO_SIDED|||||We reported the Westfall-Young adjusted p-value, using OLS regression with site fixed effects and baseline covariates. The unadjusted p-value was 0.789.|Regression, Linear||Positive (negative) estimates indicate the high cash gift group had a higher (lower) mean than the low cash gift group. Our measure of dispersion of parameter estimates is the standard error of estimate as described in our analysis plan.|||||0.784
72452152|NCT03593356|144426980|SUPERIORITY||Slope|0.578|STANDARD_ERROR_OF_MEAN|0.807||0.474|TWO_SIDED|||||We use OLS regression with site fixed effects and baseline covariates. We report unadjusted p-values.|Regression, Linear||Positive (negative) estimates indicate the high cash gift group had a higher (lower) mean than the low cash gift group. Our measure of dispersion of parameter estimates is the standard error of estimate as described in our analysis plan.|||||0.474
72452153|NCT03593356|144426987|SUPERIORITY||Slope|0.234|STANDARD_ERROR_OF_MEAN|0.882||0.871|TWO_SIDED|||||We reported the Westfall-Young adjusted p-value, using OLS regression with site fixed effects and baseline covariates. The unadjusted p-value was 0.791.|Regression, Linear||Positive (negative) estimates indicate the high cash gift group had a higher (lower) mean than the low cash gift group. Our measure of dispersion of parameter estimates is the standard error of estimate as described in our analysis plan.|||||0.871
72452154|NCT03593356|144426988|SUPERIORITY||Slope|0.021|STANDARD_ERROR_OF_MEAN|0.046||0.871|TWO_SIDED|||||We reported the Westfall-Young adjusted p-value, using OLS regression with site fixed effects and baseline covariates. The unadjusted p-value was 0.646.|Regression, Linear||Positive (negative) estimates indicate the high cash gift group had a higher (lower) mean than the low cash gift group. Our measure of dispersion of parameter estimates is the standard error of estimate as described in our analysis plan.|||||0.871
72452155|NCT03593356|144426989|SUPERIORITY||Slope|0.139|STANDARD_ERROR_OF_MEAN|0.86||0.872|TWO_SIDED|||||We use OLS regression with site fixed effects and baseline covariates. We report unadjusted p-values.|Regression, Linear||Positive (negative) estimates indicate the high cash gift group had a higher (lower) mean than the low cash gift group. Our measure of dispersion of parameter estimates is the standard error of estimate as described in our analysis plan.|||||0.872
72452156|NCT03593356|144426992|SUPERIORITY||Slope|0.133|STANDARD_ERROR_OF_MEAN|0.1||0.184|TWO_SIDED|||||We use OLS regression with site fixed effects and baseline covariates. We report unadjusted p-values.|Regression, Linear||Positive (negative) estimates indicate the high cash gift group had a higher (lower) mean than the low cash gift group. Our measure of dispersion of parameter estimates is the standard error of estimate as described in our analysis plan.|||||0.184
72452157|NCT03593356|144426995|SUPERIORITY||Slope|0.138|STANDARD_ERROR_OF_MEAN|0.173||0.415|TWO_SIDED|||||We reported the Westfall-Young adjusted p-value, using OLS regression with site fixed effects and baseline covariates. The unadjusted p-value was 0.427.|Regression, Linear||Positive (negative) estimates indicate the high cash gift group had a higher (lower) mean than the low cash gift group. Our measure of dispersion of parameter estimates is the standard error of estimate as described in our analysis plan.|||||0.415
72452158|NCT03593356|144426996|SUPERIORITY||Slope|0.086|STANDARD_ERROR_OF_MEAN|0.14||0.567|TWO_SIDED|||||We reported the Westfall-Young adjusted p-value, using OLS regression with site fixed effects and baseline covariates. The unadjusted p-value was 0.541.|Regression, Linear||Positive (negative) estimates indicate the high cash gift group had a higher (lower) mean than the low cash gift group. Our measure of dispersion of parameter estimates is the standard error of estimate as described in our analysis plan.|||||0.567
72452159|NCT00747565|144427240|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||t-test, 2 sided|||ETDRS line scores used for statistical comparisons with mean Snellen values reported above.||||<0.0001
72452160|NCT03777657|144427241|SUPERIORITY||Hazard Ratio (HR)|0.74||||0.0056|TWO_SIDED|95.0|0.59|0.94||The superiority boundary at the primary overall survival analysis was predefined using the O'Brien-Fleming boundary approximated using the Hwang-Shih-DeCani spending function at 0.0092.|One-sided Log Rank Test|One-Sided Log-Rank Test stratified by regions (Asia versus Europe/North America) and presence of peritoneal metastasis (yes vs no).|The stratified hazard ratio and two-sided 95% confidence interval were estimated using a Cox proportional hazard regression model, including treatment arm as a covariate, and region and presence of peritoneal metastasis as strata.|||0.94|0.59|0.0056
72504809|NCT03114969|144540516|SUPERIORITY||Odds Ratio (OR)|1.274||||0.679|TWO_SIDED|95.0|0.405|4.005||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.|||4.005|0.405|0.679
72452161|NCT03777657|144427242|SUPERIORITY||Hazard Ratio (HR)|0.8||||0.0011|TWO_SIDED|95.0|0.7|0.92||The one sided P value boundary for superiority of overall survival in all randomized participants at final analysis was 0.0226 based on 776 actual observed deaths.|One-Sided Log-Rank Test|One-Sided Log-Rank test stratified by region (Asia vs Europe/North America), PD-L1 expression (\<5% vs ≥5%), and presence of peritoneal metastasis.|The stratified hazard ratio and two-sided 95% confidence interval were estimated using a Cox proportional hazard regression model, including treatment arm as a covariate, and region, PD-L1 expression, and presence of peritoneal metastasis as strata.|||0.92|0.70|0.0011
72452162|NCT03777657|144427243|OTHER||Hazard Ratio (HR)|0.68|||||TWO_SIDED|95.0|0.56|0.83|||||The stratified hazard ratio and two-sided 95% confidence interval were estimated using a Cox proportional hazard regression model, including treatment arm as a covariate, and region and presence of peritoneal metastasis as strata.|||0.83|0.56|
72452163|NCT03777657|144427244|OTHER||Odds Ratio (OR)|1.45|||||TWO_SIDED|95.0|1.03|2.04|||||Odds ratio between arms weas calculated using the Cochran-Mantel-Haenszel method, stratified by regions (Asia versus Europe/North America) and presence of peritoneal metastasis.|||2.04|1.03|
72499254|NCT00393718|144529074|SUPERIORITY_OR_OTHER||Least Squares Mean|-19.97|||<|0.0001||95.0|-27.99|-11.94||A significance level of a two-sided 5% was used for statistical hypothesis testing.|ANOVA|||The analysis was performed based on an ANOVA model with treatment group and pre-trial treatment as fixed effects and corresponding baseline value as a covariate. The following null hypothesis (H0) was statistically tested against the alternative hypothesis (H1). H0: μ0.9 = μG, H1: μ0.9 ≠ μG where μ0.9 and μG are population mean after 24-week treatment for liraglutide 0.9 mg/day and glibenclamide, respectively.||-11.94|-27.99|<0.0001
72499255|NCT00393718|144529075|SUPERIORITY_OR_OTHER||Least Squares Mean|-13.03||||||95.0|-21.46|-4.6|||ANOVA|||95% confidence interval for the mean difference (liraglutide - glibenclamide) was calculated under an ANOVA model with treatment group and pre-trial treatment as fixed effects and corresponding baseline value as a covariate, and no statistical testing was performed.||-4.60|-21.46|
72499256|NCT00393718|144529076|SUPERIORITY_OR_OTHER||Least Squares Mean|-1.91|||<|0.0001||95.0|-2.34|-1.48||A significance level of a two-sided 5% was used for statistical hypothesis testing.|ANOVA|||The analysis was performed based on an ANOVA model with treatment group and pre-trial treatment as fixed effects and corresponding baseline value as a covariate. The following null hypothesis (H0) was statistically tested against the alternative hypothesis (H1). H0: μ0.9 = μG, H1: μ0.9 ≠ μG where μ0.9 and μG are population mean after 24-week treatment for liraglutide 0.9 mg/day and glibenclamide, respectively.||-1.48|-2.34|<0.0001
72499257|NCT00393718|144529077|SUPERIORITY_OR_OTHER||Least Squares Mean|-1.71||||||95.0|-2.25|-1.18|||ANOVA|||95% confidence interval for the mean difference (liraglutide - glibenclamide) was calculated under an ANOVA model with treatment group and pre-trial treatment as fixed effects and corresponding baseline value as a covariate, and no statistical testing was performed.||-1.18|-2.25|
72499258|NCT00393718|144529078|SUPERIORITY_OR_OTHER||Rate ratio|0.2||||||95.0|0.12|0.35|||Negative binomial regression model|||The relative risk for 'All hypoglycaemic episodes' and 95% confidence interval are based on a generalised linear negative-binomial model, which included treatment group as a fixed effect and log of exposure time as an offset variable.||0.35|0.12|
72499259|NCT00393718|144529078|SUPERIORITY_OR_OTHER||Rate ratio|0.18||||||95.0|0.09|0.36|||Negative binomial regression model|||The relative risk for 'Minor episodes' and 95% confidence interval are based on a generalised linear negative-binomial model, which included treatment group as a fixed effect and log of exposure time as an offset variable.||0.36|0.09|
72499260|NCT00393718|144529078|SUPERIORITY_OR_OTHER||Rate ratio|0.2||||||95.0|0.11|0.34|||Negative binomial regression model|||The relative risk for 'Symptoms only' and 95% confidence interval are based on a generalised linear negative-binomial model, which included treatment group as a fixed effect and log of exposure time as an offset variable.||0.34|0.11|
72499261|NCT03293654|144529079|EQUIVALENCE|Two treatments are judged not to be different from one another if the 90% CI of the ratio of a log-transformed exposure measure (Cmax) falls completely within the range 0.80-1.25. The PK parameter Cmax was log-transformed (base e) prior to analysis and was analysed using an ANCOVA model. The model included treatment as a fixed effect and body weight as a covariate.|Ratio of GLSM|1.28|STANDARD_DEVIATION|0.05|||TWO_SIDED|90.0|1.18|1.39|||||For the comparison, MB02 represents the numerator and US Avastin represents the denominator.|||1.39|1.18|
72499262|NCT03293654|144529079|EQUIVALENCE|Two treatments are judged not to be different from one another if the 90% CI of the ratio of a log-transformed exposure measure (Cmax) falls completely within the range 0.80-1.25. The PK parameter Cmax was log-transformed (base e) prior to analysis and was analysed using an ANCOVA model. The model included treatment as a fixed effect and body weight as a covariate.|Ratio of GLSM|1.12|STANDARD_DEVIATION|0.05|||TWO_SIDED|90.0|1.03|1.22|||||For the comparison, MB02 represents the numerator and EU Avastin represents the denominator.|||1.22|1.03|
72499263|NCT03293654|144529079|EQUIVALENCE|Two treatments are judged not to be different from one another if the 90% CI of the ratio of a log-transformed exposure measure (Cmax) falls completely within the range 0.80-1.25. The PK parameter Cmax was log-transformed (base e) prior to analysis and was analysed using an ANCOVA model. The model included treatment as a fixed effect and body weight as a covariate.|Ratio of GLSM|1.14|STANDARD_DEVIATION|0.05|||TWO_SIDED|90.0|1.05|1.24|||||Ratio of GLSM, EU is the numerator and US Avastin acts as the denominator|||1.24|1.05|
72452164|NCT03777657|144427245|OTHER||Hazard Ratio (HR)|0.78|||||TWO_SIDED|95.0|0.67|0.9|||||The stratified hazard ratio and two-sided 95% confidence interval were estimated using a Cox proportional hazard regression model, including treatment arm as a covariate, and region, PD-L1 expression, and presence of peritoneal metastasis as strata.|||0.90|0.67|
72499264|NCT03293654|144529080|EQUIVALENCE|Two treatments are judged not to be different from one another if the 90% CI of the ratio of a log-transformed exposure measure (AUC) falls completely within the range 0.80-1.25. The PK parameter AUC\[0-∞\] was log-transformed (base e) prior to analysis and was analysed using an ANCOVA model. The model included treatment as a fixed effect and body weight as a covariate.|Ratio of GLSM|1.16|STANDARD_DEVIATION|0.05|||TWO_SIDED|90.0|1.09|1.22|||||||For the comparison, MB02 represents the numerator and US Avastin represents the denominator|1.22|1.09|
72452165|NCT03777657|144427246|OTHER||Odds Ratio (OR)|1.33|||||TWO_SIDED|95.0|1.03|1.72|||||Odds ratio between arms were calculated using the Cochran-Mantel-Haenszel method, stratified by regions (Asia versus Europe/North America), PD-L1 expression and presence of peritoneal metastasis.|||1.72|1.03|
72452166|NCT03777657|144427249|OTHER||Least Squares (LS) Mean Difference|1.8|||||TWO_SIDED|95.0|-0.33|3.94|||||Mixed effect model analysis with QLQ-C30 scores from cycle 1 to 6 as the response variable, and treatment by study visit interaction, baseline mean score and randomization stratification factors as covariates.|Analysis of Change from Baseline in Global Health Status/QoL at Cycle 4||3.94|-0.33|
72452167|NCT03777657|144427249|OTHER||LS Mean Difference|2.52|||||TWO_SIDED|95.0|0.29|4.74|||||Mixed effect model analysis with QLQ-C30 scores from cycle 1 to 6 as the response variable, and treatment by study visit interaction, baseline mean score and randomization stratification factors as covariates.|Analysis of Change from Baseline in Global Health Status/QoL at Cycle 6||4.74|0.29|
72452168|NCT03777657|144427249|OTHER||LS Mean Difference|1.44|||||TWO_SIDED|95.0|-0.27|3.16||||||Analysis of Change from Baseline in Physical Functioning at Cycle 4||3.16|-0.27|
72452169|NCT03777657|144427249|OTHER||LS Mean Difference|2.46|||||TWO_SIDED|95.0|0.49|4.43|||||Mixed effect model analysis with QLQ-C30 scores from cycle 1 to 6 as the response variable, and treatment by study visit interaction, baseline mean score and randomization stratification factors as covariates.|Analysis of Change from Baseline in Physical Functioning at Cycle 6||4.43|0.49|
72452170|NCT03777657|144427250|OTHER||LS Mean Difference|-1.32|||||TWO_SIDED|95.0|-3.79|1.15|||||Mixed effect model analysis with QLQ-C30 scores from cycle 1 to 6 as the response variable, and treatment by study visit interaction, baseline mean score and randomization stratification factors as covariates.|Analysis of Change from Baseline in Fatigue at Cycle 4||1.15|-3.79|
72452171|NCT03777657|144427250|OTHER||LS Mean Difference|-3.01|||||TWO_SIDED|95.0|-5.78|-0.24|||||Mixed effect model analysis with QLQ-C30 scores from cycle 1 to 6 as the response variable, and treatment by study visit interaction, baseline mean score and randomization stratification factors as covariates.|Analysis of Change from Baseline in Fatigue at Cycle 6||-0.24|-5.78|
72452172|NCT03777657|144427251|OTHER||LS Mean Difference|-1.11|||||TWO_SIDED|95.0|-2.53|0.31|||||Mixed effect model analysis with QLQ-STO22 scores from cycle 1 to 6 as the response variable, and treatment by study visit interaction, baseline mean score and randomization stratification factors as covariates.|Analysis of Change from Baseline in QLQ-STO22 Index-Score at Cycle 4||0.31|-2.53|
72452173|NCT03777657|144427251|OTHER||LS Mean Difference|-1.62|||||TWO_SIDED|95.0|-3.12|-0.12|||||Mixed effect model analysis with QLQ-STO22 scores from cycle 1 to 6 as the response variable, and treatment by study visit interaction, baseline mean score and randomization stratification factors as covariates.|Analysis of Change from Baseline in QLQ-STO22 Index-Score at Cycle 6||-0.12|-3.12|
72452174|NCT03777657|144427251|OTHER||LS Mean Difference|-1.51|||||TWO_SIDED|95.0|-3.13|0.11|||||Mixed effect model analysis with QLQ-STO22 scores from cycle 1 to 6 as the response variable, and treatment by study visit interaction, baseline mean score and randomization stratification factors as covariates.|Analysis of Change from Baseline in QLQ-STO22 Dysphagia/Odynophagia Scale at Cycle 4||0.11|-3.13|
72562189|NCT03429049|144655707|SUPERIORITY||Least Squares Mean Difference|-0.33|STANDARD_ERROR_OF_MEAN|0.256||0.1904|TWO_SIDED|95.0|-0.84|0.17|||Mixed Models Analysis|||The NRS least squares mean difference in change from baseline between treatment arms was analyzed with a mixed model for repeated measures (MMRM). It included terms for treatment, pooled study center, baseline K L grade category for the index knee, baseline BMI category, sex, study week, treatment by visit study week interaction, and baseline average daily pain with walking NPRS (0-10) score as covariates, using an unstructured covariance structure.||0.17|-0.84|0.1904
72452175|NCT03777657|144427251|OTHER||LS Mean Difference|-0.77|||||TWO_SIDED|95.0|-2.31|0.76|||||Mixed effect model analysis with QLQ-STO22 scores from cycle 1 to 6 as the response variable, and treatment by study visit interaction, baseline mean score and randomization stratification factors as covariates.|Analysis of Change from Baseline in QLQ-STO22 Dysphagia/Odynophagia Scale at Cycle 6||0.76|-2.31|
72452176|NCT03777657|144427251|OTHER||LS Mean Difference|-2.23|||||TWO_SIDED|95.0|-4.26|-0.2|||||Mixed effect model analysis with QLQ-STO22 scores from cycle 1 to 6 as the response variable, and treatment by study visit interaction, baseline mean score and randomization stratification factors as covariates.|Analysis of Change from Baseline in QLQ-STO22 Pain/Discomfort Scale at Cycle 4||-0.20|-4.26|
72452177|NCT03777657|144427251|OTHER||LS Mean Difference|-1.88|||||TWO_SIDED|95.0|-4.03|0.27|||||Mixed effect model analysis with QLQ-STO22 scores from cycle 1 to 6 as the response variable, and treatment by study visit interaction, baseline mean score and randomization stratification factors as covariates.|Analysis of Change from Baseline in QLQ-STO22 Pain/Discomfort Scale at Cycle 6||0.27|-4.03|
72452178|NCT03777657|144427251|OTHER||LS Mean Difference|-0.93|||||TWO_SIDED|95.0|-2.85|0.99|||||Mixed effect model analysis with QLQ-STO22 scores from cycle 1 to 6 as the response variable, and treatment by study visit interaction, baseline mean score and randomization stratification factors as covariates.|Analysis of Change from Baseline in QLQ-STO22 Dietary Restrictions Scale at Cycle 4||0.99|-2.85|
72452179|NCT03777657|144427251|OTHER||LS Mean Difference|-1.32|||||TWO_SIDED|95.0|-3.42|0.77|||||Mixed effect model analysis with QLQ-STO22 scores from cycle 1 to 6 as the response variable, and treatment by study visit interaction, baseline mean score and randomization stratification factors as covariates.|Analysis of Change from Baseline in QLQ-STO22 Dietary Restrictions Scale at Cycle 6||0.77|-3.42|
72452180|NCT03777657|144427251|OTHER||LS Mean Difference|-1.59|||||TWO_SIDED|95.0|-3.28|0.09|||||Mixed effect model analysis with QLQ-STO22 scores from cycle 1 to 6 as the response variable, and treatment by study visit interaction, baseline mean score and randomization stratification factors as covariates.|Analysis of Change from Baseline in QLQ-STO22 Upper Gastro-Intestinal Symptoms at Cycle 4||0.09|-3.28|
72562190|NCT03429049|144655708|SUPERIORITY||Mean Difference (Final Values)|-2.7|STANDARD_ERROR_OF_MEAN|1.206||0.0257|TWO_SIDED|95.0|-5.07|-0.33|||Mixed Models Analysis|||The WOMAC A least squares mean difference in change from baseline between treatment arms was analyzed with a mixed model for repeated measures (MMRM). It included terms for treatment, pooled study center, baseline K L grade category for the index knee, baseline BMI category, sex, study week, treatment by visit study week interaction, and baseline average daily pain with walking NPRS (0-10) score as covariates, using an unstructured covariance structure.||-0.33|-5.07|0.0257
72562191|NCT03429049|144655709|SUPERIORITY||Least Squares Mean Difference|-0.94|STANDARD_ERROR_OF_MEAN|0.545||0.0855|TWO_SIDED|95.0|-2.01|0.13|||Mixed Models Analysis|||The WOMAC B least squares mean difference in change from baseline between treatment arms was analyzed with a mixed model for repeated measures (MMRM). It included terms for treatment, pooled study center, baseline K L grade category for the index knee, baseline BMI category, sex, study week, treatment by visit study week interaction, and baseline average daily pain with walking NPRS (0-10) score as covariates, using an unstructured covariance structure.||0.13|-2.01|0.0855
72452181|NCT03777657|144427251|OTHER||LS Mean Difference|-1.74|||||TWO_SIDED|95.0|-3.55|0.06|||||Mixed effect model analysis with QLQ-STO22 scores from cycle 1 to 6 as the response variable, and treatment by study visit interaction, baseline mean score and randomization stratification factors as covariates.|Analysis of Change from Baseline in QLQ-STO22 Upper Gastro-Intestinal Symptoms at Cycle 6||0.06|-3.55|
72452182|NCT05120856|144427267|SUPERIORITY||Slope|-1.106369|STANDARD_ERROR_OF_MEAN|0.4985347||0.026|TWO_SIDED|95.0|-2.083479|-0.129259||This is the p value for the overall group x time interaction.|Mixed Models Analysis|The model compared groups' change across all time points Time was coded as a continuous variable (i.e., 0, 4, 8, and 16).|This is the effect estimate for the group x time interaction.|||-0.129259|-2.083479|.026
72452183|NCT05120856|144427267|SUPERIORITY||Mean Difference (Final Values)|5.025|STANDARD_ERROR_OF_MEAN|8.737||0.565|TWO_SIDED|95.0|-12.098|22.149|||t-test, 2 sided|||planned between-group post-hoc comparison at 4-week follow-up||22.149|-12.098|.565
72452184|NCT05120856|144427267|SUPERIORITY||Mean Difference (Final Values)|-3.349|STANDARD_ERROR_OF_MEAN|8.891||0.706|TWO_SIDED|95.0|-20.774|14.077|||t-test, 2 sided|||Planned post-hoc comparison between groups at 8-week follow-up||14.077|-20.774|.706
72452185|NCT05120856|144427267|SUPERIORITY||Mean Difference (Final Values)|-6.921|STANDARD_ERROR_OF_MEAN|9.394||0.461|TWO_SIDED|95.0|-25.332|11.491|||t-test, 2 sided|||Planned post-hoc comparison between groups at 16-week follow-up||11.491|-25.332|.461
72452186|NCT05120856|144427267|SUPERIORITY||Slope|-1.0838|STANDARD_ERROR_OF_MEAN|0.4798||0.0252|TWO_SIDED|95.0|-2.0229626|-0.1419329||This is the p value for the group x time interaction|Mixed Models Analysis|||In an additional sensitivity analysis, past-week alcohol use data was excluded if a participant reported having been in residential/inpatient treatment where they could not access alcohol for the whole of the past week at the time of follow-up. This resulted in data for one participant in the ApBM group being excluded at week 8, and 1 control being excluded at week 16.||-0.1419329|-2.0229626|.0252
72452187|NCT05120856|144427268|SUPERIORITY||Slope|-0.016|STANDARD_ERROR_OF_MEAN|0.033||0.633|TWO_SIDED|95.0|-0.08|0.05||This is the p value for the time x group interaction.|Mixed Models Analysis|||This is the test for the overall CEQ-F scores||0.05|-0.08|.633
72452188|NCT05120856|144427268|SUPERIORITY||Slope|-0.033|STANDARD_ERROR_OF_MEAN|0.041||0.411|TWO_SIDED|95.0|-0.11|0.05||This is for the time x group interaction for the intensity subscale|Mixed Models Analysis|||This is for the test of the CEQ-F Intensity subscale score||0.05|-0.11|.411
72452189|NCT05120856|144427268|SUPERIORITY||Slope|-0.009|STANDARD_ERROR_OF_MEAN|0.036||0.808|TWO_SIDED|95.0|-0.08|0.06||p value for the time x group interaction for Imagery subscale|Mixed Models Analysis|||Analysis of CEQ-F Imagery subscale score||0.06|-0.08|.808
72452190|NCT05120856|144427268|SUPERIORITY||Slope|-0.006|STANDARD_ERROR_OF_MEAN|0.041||0.886|TWO_SIDED|95.0|-0.09|0.08||This is the p value for the time x group interaction for the Intrusiveness subscale score|Mixed Models Analysis|||This is for the analysis of the CEQ-F Intrusiveness subscale score||0.08|-0.09|.886
72452191|NCT05120856|144427269|SUPERIORITY||Slope|0.083|STANDARD_ERROR_OF_MEAN|0.066||0.207|TWO_SIDED|95.0|-0.046|0.212||This is the p value for the time x group interaction|Mixed Models Analysis|||||0.212|-0.046|.207
72452192|NCT05120856|144427270|SUPERIORITY||Slope|-0.026|STANDARD_ERROR_OF_MEAN|0.166||0.876|TWO_SIDED|95.0|-0.352|0.3||This is the p value for the group x time interaction.|Mixed Models Analysis|||||0.300|-0.352|.876
72452193|NCT05120856|144427271|SUPERIORITY||Slope|-0.069|STANDARD_ERROR_OF_MEAN|0.037||0.064|TWO_SIDED|95.0|-0.142|0.004||This is the p value for the group x time interaction|Mixed Models Analysis|||||0.004|-0.142|.064
72452194|NCT05120856|144427272|SUPERIORITY||Slope|-0.059|STANDARD_ERROR_OF_MEAN|0.143||0.679|TWO_SIDED|95.0|-0.338|0.22||This is the p value for the group x time interaction|Mixed Models Analysis|||||0.220|-0.338|.679
72452195|NCT05120856|144427274|SUPERIORITY||Slope|0.072|STANDARD_ERROR_OF_MEAN|0.086||0.403|TWO_SIDED|95.0|-0.097|0.24||This is the p value for the group x time interaction|Mixed Models Analysis|||||0.240|-0.097|.403
72452196|NCT05120856|144427275|SUPERIORITY||Slope|-0.052|STANDARD_ERROR_OF_MEAN|0.037||0.161|TWO_SIDED|95.0|-0.126|0.021||This is the p value for the group x time interaction|Mixed Models Analysis|||Linear mixed-effects model analysis of psychological well-being ratings.||0.021|-0.126|.161
72452197|NCT05120856|144427275|SUPERIORITY||Slope|-0.029|STANDARD_ERROR_OF_MEAN|0.036||0.425|TWO_SIDED|95.0|-0.099|0.042||This is the p value for the group x time interaction|Mixed Models Analysis|||Linear mixed-effects model analysis of physical well-being ratings||0.042|-0.099|.425
72452198|NCT05120856|144427275|SUPERIORITY||Slope|-0.039|STANDARD_ERROR_OF_MEAN|0.034||0.247|TWO_SIDED|95.0|-0.106|0.027||This is the p value for the group x time interaction|Mixed Models Analysis|||Linear mixed-effects model analysis of quality of life ratings||0.027|-0.106|.247
72452199|NCT05120856|144427276|SUPERIORITY||Slope|3.645|STANDARD_ERROR_OF_MEAN|10.369||0.725|TWO_SIDED|95.0|-16.68|23.97||This is the p value for the group x time interaction|Mixed Models Analysis|||||23.97|-16.68|.725
72452200|NCT00227266|144427298|SUPERIORITY_OR_OTHER_LEGACY||Spearman's correlation|0.93|||<|0.001|||||||Spearman's correlation|||MHFMS-Extend was not normally distributed at p=0.048. Test-retest reliability of MHFMS-Extend measurements from the first (S1) to the second (S2) screening visit was analyzed using Spearman's correlation.||||<0.001
72452201|NCT02549352|144427308|SUPERIORITY||Ratio of clearance rates|7.83|||<|0.001|TWO_SIDED|95.0|2.58|23.71|||Mantel Haenszel||Mantel-Haenszel estimate (0.037% relative to vehicle), adjusted for pooled sites.|||23.71|2.58|<0.001
72499265|NCT03293654|144529080|EQUIVALENCE|Two treatments are judged not to be different from one another if the 90% CI of the ratio of a log-transformed exposure measure (AUC) falls completely within the range 0.80-1.25. The PK parameter AUC\[0-∞\] was log-transformed (base e) prior to analysis and was analysed using an ANCOVA model. The model included treatment as a fixed effect and body weight as a covariate.|Ratio of GLSM|1.16|STANDARD_DEVIATION|0.05|||TWO_SIDED|90.0|1.09|1.22|||||MB02 represents the numerator and EU Avastin represents the denominator|||1.22|1.09|
72499266|NCT03293654|144529080|EQUIVALENCE|Two treatments are judged not to be different from one another if the 90% CI of the ratio of a log-transformed exposure measure (AUC) falls completely within the range 0.80-1.25. The PK parameter AUC\[0-∞\] was log-transformed (base e) prior to analysis and was analysed using an ANCOVA model. The model included treatment as a fixed effect and body weight as a covariate.|Ratio of GLSM|1.07|STANDARD_DEVIATION|0.05|||TWO_SIDED|90.0|1.0|1.13|||||EU Avastin corresponds to the numerator and US Avastin corresponds to the denominator|||1.13|1|
72619962|NCT02792257|144770995|SUPERIORITY||Difference in slopes|-0.74|STANDARD_ERROR_OF_MEAN|0.3||0.015|TWO_SIDED|95.0|-1.328|-0.152|||Regression, Linear||standard error NOT standard error of the mean|Efficacy is assessed by fitting a longitudinal linear GEE model with the co primary outcomes and with time, treatment arm, and their interaction. Analyses are adjusted for site and for use of antidepressants and antipsychotics at baseline. The treatment by week interaction is the coefficient of interest and represents the difference in change in outcome per week between the two arms.||-0.152|-1.328|.015
72622444|NCT02181413|144774859|SUPERIORITY||Hazard Ratio (HR)|0.612||||0.034|TWO_SIDED|95.0|0.386|0.969||P-value was based on log-rank test stratified by pre-induction regimen, ISS stage and response after transplantation.|Log Rank||Hazard ratio is based on an unadjusted Cox's proportional hazard regression model stratified by induction regimen, pre-induction ISS, and response after transplantation, comparing the hazard rate of Ixazomib arm over the hazard rate of Placebo arm.|MRD- at Study Entry||0.969|0.386|0.034
72452202|NCT02549352|144427309|SUPERIORITY||Ratio of clearance rates|5.91|||<|0.001|TWO_SIDED|95.0|3.32|10.51|||Mantel Haenszel||Mantel-Haenszel estimate (0.037% relative to vehicle), adjusted for pooled sites.|The p-values for secondary endpoints have been corrected by the Holm-Bonferroni method to account for multiplicity. The prespecified multiplicity adjustment by the Holm-Bonferroni method requires the ordering of the p-values for the secondary endpoints by size.||10.51|3.32|<0.001
72452203|NCT02549352|144427310|SUPERIORITY||Ratio of clearance rates|7.59|||<|0.001|TWO_SIDED|95.0|3.7|15.61|||Mantel Haenszel||Mantel-Haenszel estimate (0.037% relative to vehicle), adjusted for pooled sites.|The p-values for secondary endpoints have been corrected by the Holm-Bonferroni method to account for multiplicity. The prespecified multiplicity adjustment by the Holm-Bonferroni method requires the ordering of the p-values for the secondary endpoints by size.||15.61|3.70|<0.001
72452204|NCT02549352|144427311|SUPERIORITY||Week 8 AK count ratio|0.3|||<|0.001|TWO_SIDED|95.0|0.25|0.36||Negative binominal regression with treatment group and pooled site as factors and log baseline count as offset variable.|Mantel Haenszel||0.037% relative to vehicle.|The p-values for secondary endpoints have been corrected by the Holm-Bonferroni method to account for multiplicity. The prespecified multiplicity adjustment by the Holm-Bonferroni method requires the ordering of the p-values for the secondary endpoints by size.||0.36|0.25|<0.001
72452205|NCT05048394|144427312|EQUIVALENCE|Equivalence is defined as a difference of 0.|||||<|0.001||||||Threshold for statistical significance was p = 0.05.|Wilcoxon (Mann-Whitney)|||||||<0.001
72452206|NCT05048394|144427313|EQUIVALENCE|Equivalence is defined as a difference of 0.||||||0.14||||||Threshold for significance was p = 0.05.|Wilcoxon (Mann-Whitney)|||||||0.14
72452207|NCT03455985|144427379|SUPERIORITY||Mean Difference (Net)|0.07|STANDARD_ERROR_OF_MEAN|0.4||0.09|TWO_SIDED||||||Regression, Linear|||||||0.09
72452208|NCT03455985|144427380|SUPERIORITY||Mean Difference (Net)|-0.5|STANDARD_ERROR_OF_MEAN|0.4||0.2|TWO_SIDED||||||Regression, Linear|||||||0.20
72499267|NCT03293654|144529087|EQUIVALENCE|Two treatments are judged not to be different from one another if the 90% CI of the ratio of a log-transformed exposure measure (AUC) falls completely within the range 0.80-1.25. The PK parameter AUC\[0-∞\] was log-transformed (base e) prior to analysis and was analysed using an ANCOVA model. The model included treatment as a fixed effect and body weight as a covariate.|Ratio of GLSM|1.02|STANDARD_DEVIATION|0.05|||TWO_SIDED|90.0|0.962|1.07|||||MB02 in numerator and EU Avastin in denominator|||1.07|0.962|
72499268|NCT03293654|144529087|EQUIVALENCE|Two treatments are judged not to be different from one another if the 90% CI of the ratio of a log-transformed exposure measure (AUC) falls completely within the range 0.80-1.25. The PK parameter AUC\[0-∞\] was log-transformed (base e) prior to analysis and was analysed using an ANCOVA model. The model included treatment as a fixed effect and body weight as a covariate.|Ratio of GLSM|1.06|STANDARD_DEVIATION|0.05|||TWO_SIDED|90.0|0.996|1.13|||||MB02 is numerator and US Avastin is denominator|||1.13|0.996|
72452209|NCT03455985|144427381|SUPERIORITY||||||>|0.99|||||||Fisher Exact|||||||>0.99
72452210|NCT03455985|144427382|SUPERIORITY||Mean Difference (Final Values)|-26.5|STANDARD_ERROR_OF_MEAN|30.3||0.39|TWO_SIDED||||||Regression, Linear|||||||0.39
72452211|NCT02347332|144427383|SUPERIORITY|||||||0.8329|TWO_SIDED|95.0||||Threshold significance value p\<0.05|Log Rank|||||||0.8329
72452212|NCT02347332|144427384|SUPERIORITY|||||||0.3576|TWO_SIDED|95.0||||Threshold significance value p\<0.05|Log Rank|||||||0.3576
72452213|NCT02347332|144427385|SUPERIORITY|||||||0.467|TWO_SIDED|95.0||||Threshold significance value p\<0.05|Log Rank|||||||0.467
72452214|NCT02347332|144427386|SUPERIORITY|||||||0.243|TWO_SIDED|95.0||||Threshold significance value p\<0.05|Log Rank|||||||0.243
72452215|NCT02347332|144427387|SUPERIORITY|||||||0.6289|TWO_SIDED|95.0||||Threshold significance value p\<0.05|Log Rank|||||||0.6289
72452216|NCT00112359|144427388|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.98||||0.0006|TWO_SIDED|95.0|3.5|12.47||No adjustments were made for multiple comparisons.|ANCOVA|ANCOVA model included treatment, baseline CFQ-R RSS, and disease severity (FEV1 \>50% or \<=50% pred.). Treatment differences: AZLI-placebo.||Null hypothesis was there was no difference between 75 mg AZLI TID and placebo treatment groups in change from baseline in CFQ-R RSS score at Day 14.||12.47|3.50|0.0006
72452217|NCT00112359|144427389|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.33||||0.0154|TWO_SIDED|95.0|1.22|11.43||No adjustments were made for multiple comparisons.|ANCOVA|ANCOVA model included treatment, baseline CFQ-R RSS, and disease severity (FEV1 \>50% or \<=50% pred.). Treatment differences: AZLI-placebo.||Null hypothesis was there was no difference between 75 mg AZLI TID and placebo treatment groups in change from baseline in CFQ-R RSS score at Day 42.||11.43|1.22|0.0154
72452218|NCT00112359|144427392|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|10.294|||<|0.0001|TWO_SIDED|95.0|6.288|14.299||Analysis based on two-sided test with an 0.025 a priori threshold for statistical significance as part of the methods used to control the family-wise type 1 error.|ANCOVA|ANCOVA model included treatment, disease severity (FEV1 \>50% or \<=50% pred.), and Day 0 FEV1. Treatment differences: AZLI-placebo.||Null hypothesis was there was no difference between 75 mg AZLI TID and placebo treatment groups in percent change in FEV1 at Day 28.||14.299|6.288|<0.0001
72452219|NCT00112359|144427393|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.453|||<|0.0001|TWO_SIDED|95.0|-2.115|-0.791||Analysis based on 2-sided test with an 0.025 a priori threshold for statistical significance as part of methods used to control family-wise type 1 error.|ANCOVA|ANCOVA model included terms for treatment and disease severity (FEV1 \>50% or \<=50% pred.). Treatment differences calculated as AZLI-placebo.||Null hypothesis was there was no difference between 75 mg AZLI TID and placebo treatment groups in change in log10 PA CFUs in sputum at Day 28.||-0.791|-2.115|< 0.0001
72452220|NCT00112359|144427394|SUPERIORITY_OR_OTHER|||||||0.2364||95.0||||Analysis based on 2-sided test with an 0.025 a priori threshold for statistical significance as part of methods used to control family-wise type 1 error.|Fisher Exact|Comparison by treatment for proportion of subjects using additional (nonprotocol-specified) antipseudomonal antibiotics at least once during study.||Null hypothesis was there was no difference between 75 mg AZLI TID and placebo treatment groups in number of participants using additional (nonprotocol-specified) antipseudomonal antibiotics during study.||||0.2364
72452221|NCT00112359|144427395|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.71||||0.0005|TWO_SIDED|95.0|4.31|15.11||"Primary endpoint analysis based on 2-sided test with an 0.05 a priori threshold for statistical significance.~A gate-keeping procedure to control family-wise Type 1 error was established a priori for primary and key secondary endpoints."|ANCOVA|ANCOVA model includes treatment, baseline CFQ-R RSS, and disease severity (FEV1 \>50% or \<=50% pred.). Treatment differences: AZLI-placebo.||"Null hypothesis was there was no difference between 75 mg AZLI TID and placebo treatment groups in change from baseline in CFQ-R RSS score at Day 28.~A sample size of 70 participants per treatment group provided approximately 77% power to detect an 8-point difference in CFQ-R RSS score between treatment groups, assuming a standard deviation (SD) of 20 and a Type I error rate of 0.05."||15.11|4.31|0.0005
72452222|NCT00112359|144427396|SUPERIORITY_OR_OTHER|||||||0.064||0.0||||No adjustments were made for multiple comparisons.|Fisher Exact|Comparison by treatment group for proportion of participants hospitalized at least once between Day 0 and Day 42 (or 14 days after last study dose).||Null hypothesis was there was no difference between 75 mg AZLI TID and placebo treatment groups in number of participants hospitalized at least once during the study.||||0.0640
72452223|NCT01988402|144427398|SUPERIORITY_OR_OTHER|||||||0.5|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.5
72452224|NCT01961609|144427402|SUPERIORITY_OR_OTHER||Percentage|65.3|||<|0.0001|TWO_SIDED|99.375|52.4|76.7|||two-sided binomial exact test||A Bonferroni adjustment adjusting for 8 analyses have been applied.|||76.7|52.4|<0.0001
72452225|NCT00571649|144427420|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.771||||0.0211||95.0|0.618|0.962||Hochberg procedure: A 2-sided p-value of less than 0.05 would be considered significant, if the 1-sided p-value of the other primary efficacy outcome measure was less than 0.025, elsewise a p-value of less than 0.025 would be considered significant.|Cochran-Mantel-Haenszel|Weighted relative risks were calculated using asymptotic methods, with weights based upon sample sizes per strata (geographic region).||A sample size of 2876 valid patients per group was estimated to obtain a joint power of at least 90% for both primary endpoints (91.4% for superiority) with 4% event rate at day 35 for comparator and 40% relative risk reduction.||0.962|0.618|0.0211
72452226|NCT00571649|144427421|NON_INFERIORITY_OR_EQUIVALENCE|Rivaroxaban would be considered at least as effective as the comparator if the upper limit of the CI (Confidence Interval) was less than 1.5|Risk Ratio (RR)|0.968||||0.0025||95.0|0.713|1.314||Hochberg procedure: A 1-sided p-value of less than 0.025 would be considered significant, if the 2-sided p-value of the other primary efficacy outcome measure was less than 0.05, elsewise a p-value of less than 0.0125 would be considered significant.|Cochran-Mantel-Haenszel|Weighted relative risks were calculated using asymptotic methods, with weights based upon sample sizes per strata (geographic region).||A sample size of 2876 valid patients per group was estimated to obtain a joint power of at least 90% for both primary endpoints (98.6% power for non-inferiority) with 1.8% event rate at day 10 for comparator and 35% relative risk reduction.||1.314|0.713|0.0025
72452227|NCT00571649|144427422|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.931||||0.3758||95.0|0.795|1.091||Test hierarchy: A p-value of less than 0.05 would be considered significant, if the tests for the two primary efficacy outcome measures were significant.|Cochran-Mantel-Haenszel|Weighted relative risks were calculated using asymptotic methods, with weights based upon sample sizes per strata (geographic region).||||1.091|0.795|0.3758
72499269|NCT03293654|144529087|EQUIVALENCE|Two treatments are judged not to be different from one another if the 90% CI of the ratio of a log-transformed exposure measure (AUC) falls completely within the range 0.80-1.25. The PK parameter AUC\[0-∞\] was log-transformed (base e) prior to analysis and was analysed using an ANCOVA model. The model included treatment as a fixed effect and body weight as a covariate.|Ratio of GLSM|1.04|STANDARD_DEVIATION|0.05|||TWO_SIDED|90.0|0.983|1.11|||||EU Avastin in the numerator and US Avastin in the denominator|||1.11|0.983|
72499270|NCT03293654|144529088|EQUIVALENCE|Two treatments are judged not to be different from one another if the 90% CI of the ratio of a log-transformed exposure measure (AUC) falls completely within the range 0.80-1.25. The PK parameter AUC\[0-∞\] was log-transformed (base e) prior to analysis and was analysed using an ANCOVA model. The model included treatment as a fixed effect and body weight as a covariate.|Ratio of GLSM|1.02|STANDARD_DEVIATION|0.05|||TWO_SIDED|90.0|0.969|1.07|||||MB02: EU Avastin|||1.07|0.969|
72619963|NCT02792257|144770996|SUPERIORITY||Difference in slopes|-1.26|STANDARD_ERROR_OF_MEAN|0.75||0.094|TWO_SIDED|95.0|-2.73|0.21|||Regression, Linear||standard error not standard error of the mean|Efficacy is assessed by fitting a longitudinal linear GEE model with the co primary outcomes and with time, treatment arm, and their interaction. Analyses are adjusted for site and for use of antidepressants and antipsychotics at baseline. The treatment by week interaction is the coefficient of interest and represents the difference in change in outcome per week between the two arms.||0.21|-2.73|.094
72619964|NCT02792257|144770997|SUPERIORITY||Incident rate ratio|1.14|STANDARD_ERROR_OF_MEAN|0.26||0.57|TWO_SIDED|95.0|0.73|1.79|||Regression, Logistic|The original analytic plan called for a logistic regression of ever/never SAE as a function of treatment assignment.|not standard error of the mean just standard error.|||1.79|0.73|.57
72452228|NCT00571649|144427423|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.991||||0.9473||95.0|0.753|1.304||"Test hierarchy: A p-value of less than 0.05 would be considered significant, if the tests for the 2 primary efficacy outcomes and for Composite endpoint of VTE (any DVT, non fatal PE) and all-cause mortality up to Day 35 + 6 days were significant."|Cochran-Mantel-Haenszel|Weighted relative risks were calculated using asymptotic methods, with weights based upon sample sizes per strata (geographic region).||||1.304|0.753|0.9473
72452229|NCT00571649|144427432|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|2.455|||<|0.0001|TWO_SIDED|95.0|1.854|3.251||2-sided p-value. No adjustment for multiple testing.|Cochran-Mantel-Haenszel|Weighted relative risks were calculated using asymptotic methods, with weights based upon sample sizes per strata (geographic region).||There was no sample size estimation as this was not planed as confirmatory analysis||3.251|1.854|<0.0001
72452230|NCT00571649|144427433|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|2.272|||<|0.0001|TWO_SIDED|95.0|1.628|3.171||2-sided p-value. No adjustment for multiple testing.|Cochran-Mantel-Haenszel|||There was no sample size estimation as this was not planed as confirmatory analysis||3.171|1.628|<0.0001
72452231|NCT03983434|144427441|OTHER|Due to the skewness of the data, outcome measures were summarized using median and interquartile range.||||||0.62|||||||Kruskal-Wallis|||||||.62
72452232|NCT03983434|144427442|OTHER|Due to the skewness of the data, outcome measures were summarized using median and interquartile range.||||||0.17|||||||Kruskal-Wallis|||||||0.17
72452233|NCT03983434|144427443|OTHER|Due to the skewness of the data, outcome measures were summarized using median and interquartile range.||||||0.17|||||||Kruskal-Wallis|||||||0.17
72452234|NCT03983434|144427444|OTHER|Due to the skewness of the data, outcome measures were summarized using median and interquartile range.||||||0.079|||||||Kruskal-Wallis|||||||0.079
72452235|NCT03983434|144427445|OTHER|Due to the skewness of the data, outcome measures were summarized using median and interquartile range.||||||0.47|||||||Kruskal-Wallis|||||||0.47
72452236|NCT03983434|144427447|OTHER|Due to the skewness of the data, outcome measures were summarized using median and interquartile range.||||||0.03|||||||Kruskal-Wallis|||||||0.03
72452237|NCT03983434|144427448|OTHER|Due to the skewness of the data, outcome measures were summarized using median and interquartile range.||||||0.14|||||||Kruskal-Wallis|||||||0.14
72452238|NCT03983434|144427449|OTHER|Due to the skewness of the data, outcome measures were summarized using median and interquartile range.||||||0.074|||||||Kruskal-Wallis|||||||0.074
72452239|NCT03983434|144427450|OTHER|||||||0.004|||||||Kruskal-Wallis|||||||0.004
72452240|NCT03983434|144427451|OTHER|||||||0.17|||||||Kruskal-Wallis|||||||0.17
72452241|NCT03983434|144427452|OTHER|Due to the skewness of the data, outcome measures were summarized using median and interquartile range.||||||0.98|||||||Kruskal-Wallis|||||||0.98
72452242|NCT04027439|144427508|OTHER||Contrast Ratio|1.186|||<|0.0001|TWO_SIDED|95.0|1.138|1.235|||ANCOVA|||||1.235|1.138|<0.0001
72452243|NCT04027439|144427508|OTHER||Contrast Ratio|1.134|||<|0.0001|TWO_SIDED|95.0|1.088|1.181|||ANCOVA|||||1.181|1.088|<0.0001
72452244|NCT04027439|144427508|OTHER||Contrast Ratio|1.134|||<|0.0001|TWO_SIDED|95.0|1.089|1.181|||ANCOVA|||||1.181|1.089|<0.0001
72452245|NCT04027439|144427508|OTHER||Contrast Ratio|1.084||||0.0001|TWO_SIDED|95.0|1.041|1.128|||ANCOVA|||||1.128|1.041|0.0001
72452246|NCT04027439|144427509|OTHER||Contrast Ratio|1.228||||0.0004|TWO_SIDED|95.0|1.105|1.365|||ANCOVA|||||1.365|1.105|0.0004
72452247|NCT04027439|144427509|OTHER||Contrast Ratio|1.228||||0.0004|TWO_SIDED|95.0|1.104|1.365|||ANCOVA|||||1.365|1.104|0.0004
72452248|NCT04027439|144427509|OTHER||Contrast Ratio|1.196||||0.0012|TWO_SIDED|95.0|1.08|1.326|||ANCOVA|||||1.326|1.080|0.0012
72452249|NCT04027439|144427509|OTHER||Contrast Ratio|1.121||||0.0348|TWO_SIDED|95.0|1.009|1.246|||ANCOVA|||||1.246|1.009|0.0348
72452250|NCT04027439|144427509|OTHER||Contrast Ratio|1.055||||0.3106|TWO_SIDED|95.0|0.949|1.172|||ANCOVA|||||1.172|0.949|0.3106
72452251|NCT04027439|144427510|OTHER||Contrast Ratio|1.154||||0.0208|TWO_SIDED|95.0|1.024|1.301|||ANCOVA|||||1.301|1.024|0.0208
72452252|NCT04027439|144427510|OTHER||Contrast Ratio|1.2||||0.0041|TWO_SIDED|95.0|1.064|1.353|||ANCOVA|||||1.353|1.064|0.0041
72452253|NCT04027439|144427510|OTHER||Contrast Ratio|1.167||||0.0108|TWO_SIDED|95.0|1.039|1.311|||ANCOVA|||||1.311|1.039|0.0108
72452254|NCT04027439|144427510|OTHER||Contrast Ratio|1.087||||0.1641|TWO_SIDED|95.0|0.965|1.225|||ANCOVA|||||1.225|0.965|0.1641
72452255|NCT04027439|144427511|OTHER||Contrast Ratio|1.229||||0.0005|TWO_SIDED|95.0|1.102|1.369|||ANCOVA|||||1.369|1.102|0.0005
72452256|NCT04027439|144427511|OTHER||Contrast Ratio|1.231||||0.0005|TWO_SIDED|95.0|1.104|1.372|||ANCOVA|||||1.372|1.104|0.0005
72452257|NCT04027439|144427511|OTHER||Contrast Ratio|1.188||||0.0022|TWO_SIDED|95.0|1.07|1.32|||ANCOVA|||||1.320|1.070|0.0022
72452258|NCT04027439|144427511|OTHER||Contrast Ratio|1.106||||0.0658|TWO_SIDED|95.0|0.993|1.233|||ANCOVA|||||1.233|0.993|0.0658
72452259|NCT04027439|144427519|OTHER||Contrast Ratio|1.183|||<|0.0001|TWO_SIDED|95.0|1.134|1.234|||ANCOVA|||||1.234|1.134|<0.0001
72452260|NCT04027439|144427519|OTHER||Contrast Ratio|1.14|||<|0.0001|TWO_SIDED|95.0|1.092|1.19|||ANCOVA|||||1.190|1.092|<0.0001
72452261|NCT04027439|144427519|OTHER||Contrast Ratio|1.131|||<|0.0001|TWO_SIDED|95.0|1.084|1.18|||ANCOVA|||||1.180|1.084|<0.0001
72452262|NCT04027439|144427519|OTHER||Contrast Ratio|1.08||||0.0004|TWO_SIDED|95.0|1.036|1.126|||ANCOVA|||||1.126|1.036|0.0004
72452263|NCT04027439|144427520|OTHER||Contrast Ratio|1.123|||<|0.0001|TWO_SIDED|95.0|1.078|1.169|||ANCOVA|||||1.169|1.078|<0.0001
72452264|NCT04027439|144427520|OTHER||Contrast Ratio|1.078||||0.0004|TWO_SIDED|95.0|1.035|1.122|||ANCOVA|||||1.122|1.035|0.0004
72452265|NCT04027439|144427520|OTHER||Contrast Ratio|1.081||||0.0002|TWO_SIDED|95.0|1.039|1.125|||ANCOVA|||||1.125|1.039|0.0002
72452266|NCT04027439|144427520|OTHER||Contrast Ratio|1.041||||0.0437|TWO_SIDED|95.0|1.001|1.083|||ANCOVA|||||1.083|1.001|0.0437
72452267|NCT04027439|144427521|OTHER||Contrast Ratio|1.087||||0.0006|TWO_SIDED|95.0|1.038|1.139|||ANCOVA|||||1.139|1.038|0.0006
72452268|NCT04027439|144427521|OTHER||Contrast Ratio|1.083||||0.001|TWO_SIDED|95.0|1.034|1.135|||ANCOVA|||||1.135|1.034|0.0010
72452269|NCT04027439|144427521|OTHER||Contrast Ratio|1.096||||0.0002|TWO_SIDED|95.0|1.047|1.149|||ANCOVA|||||1.149|1.047|0.0002
72452270|NCT04027439|144427521|OTHER||Contrast Ratio|1.039||||0.0971|TWO_SIDED|95.0|0.993|1.088|||ANCOVA|||||1.088|0.993|0.0971
72452271|NCT04027439|144427522|OTHER||Contrast Ratio|1.145|||<|0.0001|TWO_SIDED|95.0|1.106|1.185|||ANCOVA|||||1.185|1.106|<0.0001
72562192|NCT03429049|144655710|SUPERIORITY||Mean Difference (Final Values)|-7.8|STANDARD_ERROR_OF_MEAN|4.096||0.055|TWO_SIDED|95.0|-15.86|0.26|||Mixed Models Analysis|||The WOMAC C least squares mean difference in change from baseline between treatment arms was analyzed with a mixed model for repeated measures (MMRM). It included terms for treatment, pooled study center, baseline K L grade category for the index knee, baseline BMI category, sex, study week, treatment by visit study week interaction, and baseline average daily pain with walking NPRS (0-10) score as covariates, using an unstructured covariance structure.||0.26|-15.86|0.0550
72619965|NCT00553475|144770998|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.63||||0.0075||95.0|-1.09|-0.17|||ANCOVA|Treatment groups and the CLcr strata as factors and baseline values as covariates.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.17|-1.09|0.0075
72452272|NCT04027439|144427522|OTHER||Contrast Ratio|1.148|||<|0.0001|TWO_SIDED|95.0|1.109|1.189|||ANCOVA|||||1.189|1.109|<0.0001
72452273|NCT04027439|144427522|OTHER||Contrast Ratio|1.099|||<|0.0001|TWO_SIDED|95.0|1.062|1.137|||ANCOVA|||||1.137|1.062|<0.0001
72452274|NCT04027439|144427522|OTHER||Contrast Ratio|1.088|||<|0.0001|TWO_SIDED|95.0|1.052|1.126|||ANCOVA|||||1.126|1.052|<0.0001
72452275|NCT04027439|144427523|OTHER||Contrast Ratio|1.15|||<|0.0001|TWO_SIDED|95.0|1.113|1.189|||ANCOVA|||||1.189|1.113|<0.0001
72452276|NCT04027439|144427523|OTHER||Contrast Ratio|1.146|||<|0.0001|TWO_SIDED|95.0|1.109|1.185|||ANCOVA|||||1.185|1.109|<0.0001
72452277|NCT04027439|144427523|OTHER||Contrast Ratio|1.107|||<|0.0001|TWO_SIDED|95.0|1.071|1.144|||ANCOVA|||||1.144|1.071|<0.0001
72452278|NCT04027439|144427523|OTHER||Contrast Ratio|1.094|||<|0.0001|TWO_SIDED|95.0|1.059|1.13|||ANCOVA|||||1.130|1.059|<0.0001
72452279|NCT04027439|144427524|OTHER||Contrast Ratio|1.103|||<|0.0001|TWO_SIDED|95.0|1.066|1.141|||ANCOVA|||||1.141|1.066|<0.0001
72452280|NCT04027439|144427524|OTHER||Contrast Ratio|1.078|||<|0.0001|TWO_SIDED|95.0|1.042|1.116|||ANCOVA|||||1.116|1.042|<0.0001
72452281|NCT04027439|144427524|OTHER||Contrast Ratio|1.067||||0.0002|TWO_SIDED|95.0|1.032|1.104|||ANCOVA|||||1.104|1.032|0.0002
72562193|NCT02459418|144655739|EQUIVALENCE|The 90% CIs of the ratios of geometric means of log-transformed baseline corrected AUC(0-last) were used to assess bioequivalence between Gonal-f® RFF and AFOLIA using the bioequivalence interval of 80.00% to 125.00%.|Geometric LS Mean Ratio|164.96|||||TWO_SIDED|90.0|137.82|197.45||||||A mixed-effects analysis of variance (ANOVA) model with sequence, treatment and period as fixed effects, and subject nested within sequence as random effect was used. Least squares (LS) means and 90% confidence intervals (CIs) for treatment differences on log-scale were obtained and back transformed to provide geometric LS mean ratios of AFOLIA over Gonal-f® RFF.||197.45|137.82|
72619966|NCT00553475|144770998|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.74||||0.0254||95.0|-1.39|-0.09|||ANCOVA|Treatment groups and the CLcr strata as factors and baseline values as covariates.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.09|-1.39|0.0254
72452282|NCT04027439|144427524|OTHER||Contrast Ratio|1.048||||0.0066|TWO_SIDED|95.0|1.013|1.084|||ANCOVA|||||1.084|1.013|0.0066
72452283|NCT00979121|144427561|SUPERIORITY_OR_OTHER||difference in % of pts alive at 60 days|4.0||||0.21|TWO_SIDED|95.0|-2.3|10.2||The monitoring boundaries were designed to have a low probability of stopping for futility before 750 patients. The maximum sample size was 1000 patients. Efficacy stopping was based on mortality; futility stopping was based on mortality and VFDs.|Proc lifetest|Proc lifetest was used to calculate mortality mean and variance due to one subject lost to follow up who was censored.||Hospital mortality to day 60 was estimated using the Kaplan Meier estimate, with patients discharged home before day 60 considered alive at day 60. The analysis was stratified by co-enrolled treatment assignments for 81 patients also enrolled in a randomized clinical trial of two different nutritional strategies. A maximum of 1000 patients were to be enrolled, providing a 92% probability of rejecting the null hypothesis for the effect on mortality if a true difference in mortality was 9%.||10.2|-2.3|0.21
72452284|NCT00979121|144427562|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.96||95.0|-1.6|1.5|||ANCOVA|||Ventilator, ICU free, and organ failure free days were analyzed by analysis of variance, utilizing treatment assignment where applicable.||1.5|-1.6|0.96
72452285|NCT00859781|144427578|SUPERIORITY||proportion difference|0.26||||0.08|TWO_SIDED|95.0|0.008|0.52|||Fisher Exact||Direction = 177Lu-J591 + Ketoconazole proportion free of radiographically evident metastases minus 111ln-J591 + Ketoconazole proportion free of radiographically evident metastases.|||0.52|0.008|0.08
72452286|NCT02678689|144427610|SUPERIORITY|The two-sample T-test with unequal variance was conducted at a significance level of 0.05|||||<|0.0001|||||||t-test, unequal variance|||||||< 0.0001
72452287|NCT02678689|144427611|SUPERIORITY||Hazard Ratio (HR)|0.091|||<|0.0001|TWO_SIDED|95.0|0.021|0.393|||Cox Model Wald Test||Hazard ratio is based on Cox proportional hazards model with a factor of study group|||0.393|0.021|<.0001
72452288|NCT02678689|144427612|SUPERIORITY||Hazard Ratio (HR)|0.0||||0.0032|TWO_SIDED|95.0|0.0|0.0|||Cox Model Wald Test||Hazard ratio is based on Cox proportional hazards model with a factor of study group|||0.000|0.000|0.0032
72452289|NCT02678689|144427613|SUPERIORITY||||||<|0.0001|||||||t-test, unequal variance|||||||<.0001
72452290|NCT02678689|144427614|SUPERIORITY||||||<|0.0001|||||||t-test, unequal variance|||||||<.0001
72452291|NCT02678689|144427615|SUPERIORITY||Hazard Ratio (HR)|0.209||||0.0081|TWO_SIDED|95.0|0.059|0.735|||Cox Model Wald Test|The p value is a test that the hazard ratio equal to 1.|"Hazard ratio is based on Cox proportional hazards model with a factor of study group.~Hazard Ratio (HR) 190-203 vs DEM-CHILD."|||0.735|0.059|0.0081
72452292|NCT02307682|144427678|NON_INFERIORITY|The non-inferiority margin was 4 letters.|Least Squares Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.98||0.0003|TWO_SIDED|95.0|-2.5|1.3||1-sided p-value reported. Hypothesis tested according to the pre-specified hierarchical testing that ensures the global type I error rate at 0.05.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|||1.3|-2.5|0.0003
72452293|NCT02307682|144427678|NON_INFERIORITY|The non-inferiority margin was 4 letters.|Least Squares Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|1.0|<|0.0001|TWO_SIDED|95.0|-2.1|1.8||1-sided p-value reported. Hypothesis tested according to the pre-specified hierarchical testing that ensures the global type I error rate at 0.05.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|||1.8|-2.1|<0.0001
72452294|NCT02307682|144427679|NON_INFERIORITY|The non-inferiority margin was 4 letters.|Least Squares Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.95||0.0001|TWO_SIDED|95.0|-2.4|1.3||1-sided p-value reported. Hypothesis tested according to the pre-specified hierarchical testing that ensures the global type I error rate at 0.05.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|||1.3|-2.4|0.0001
72499271|NCT03293654|144529088|EQUIVALENCE|Two treatments are judged not to be different from one another if the 90% CI of the ratio of a log-transformed exposure measure (AUC) falls completely within the range 0.80-1.25. The PK parameter AUC\[0-∞\] was log-transformed (base e) prior to analysis and was analysed using an ANCOVA model. The model included treatment as a fixed effect and body weight as a covariate.|Ratio of GLSM|1.06|STANDARD_DEVIATION|0.05|||TWO_SIDED|90.0|0.998|1.12|||||MB02: US Avastin|||1.12|0.998|
72452295|NCT02307682|144427679|NON_INFERIORITY|The non-inferiority margin was 4 letters.|Least Squares Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.96|<|0.0001|TWO_SIDED|95.0|-1.9|1.9||1-sided p-value reported. Hypothesis tested according to the pre-specified hierarchical testing that ensures the global type I error rate at 0.05.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|||1.9|-1.9|<0.0001
72452296|NCT02307682|144427684|OTHER|Treatment difference|Least Squares Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.59|||TWO_SIDED|95.0|-1.4|0.9||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 4||0.9|-1.4|
72452297|NCT02307682|144427684|OTHER|Treatment difference|Least Squares Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.64|||TWO_SIDED|95.0|-1.4|1.1||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|||1.1|-1.4|
72452298|NCT02307682|144427684|OTHER|Treatment difference|Least Squares Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.67|||TWO_SIDED|95.0|-1.4|1.2||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 8||1.2|-1.4|
72452299|NCT02307682|144427684|OTHER|Treatment difference|Least Squares Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.73|||TWO_SIDED|95.0|-1.7|1.2||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 8||1.2|-1.7|
72452300|NCT02307682|144427684|OTHER|Treatment difference|Least Squares Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.76|||TWO_SIDED|95.0|-1.8|1.2||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 12||1.2|-1.8|
72452301|NCT02307682|144427684|OTHER|Treatment difference|Least Squares Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.8|||TWO_SIDED|95.0|-1.5|1.6||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 12||1.6|-1.5|
72452302|NCT02307682|144427684|OTHER|Treatment difference|Least Squares Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.82|||TWO_SIDED|95.0|-1.8|1.5||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 16||1.5|-1.8|
72452303|NCT02307682|144427684|OTHER|Treatment difference|Least Squares Mean Difference|0.5|STANDARD_ERROR_OF_MEAN|0.82|||TWO_SIDED|95.0|-1.1|2.1||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 16||2.1|-1.1|
72452304|NCT02307682|144427684|OTHER|Treatment difference|Least Squares Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.83|||TWO_SIDED|95.0|-2.2|1.0||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 20||1.0|-2.2|
72452305|NCT02307682|144427684|OTHER|Treatment difference|Least Squares Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.86|||TWO_SIDED|95.0|-2.2|1.2||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 20||1.2|-2.2|
72452306|NCT02307682|144427684|OTHER|Treatment difference|Least Squares Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.87|||TWO_SIDED|95.0|-2.1|1.3||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 24||1.3|-2.1|
72452307|NCT02307682|144427684|OTHER|Treatment difference|Least Squares Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.88|||TWO_SIDED|95.0|-1.9|1.6||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 24||1.6|-1.9|
72452308|NCT02307682|144427684|OTHER|Treatment difference|Least Squares Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.92|||TWO_SIDED|95.0|-1.9|1.7||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 28||1.7|-1.9|
72452309|NCT02307682|144427684|OTHER|Treatment difference|Least Squares Mean Difference|0.4|STANDARD_ERROR_OF_MEAN|0.92|||TWO_SIDED|95.0|-1.4|2.2||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 28||2.2|-1.4|
72499272|NCT03293654|144529088|EQUIVALENCE|Two treatments are judged not to be different from one another if the 90% CI of the ratio of a log-transformed exposure measure (AUC) falls completely within the range 0.80-1.25. The PK parameter AUC\[0-∞\] was log-transformed (base e) prior to analysis and was analysed using an ANCOVA model. The model included treatment as a fixed effect and body weight as a covariate.|Ratio of GLSM|1.04|STANDARD_DEVIATION|0.05|||TWO_SIDED|90.0|0.981|1.1|||||EU Avastin: US Avastin|||1.1|0.981|
72619967|NCT00553475|144770999|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.28||||0.8731||95.0|-3.67|3.12|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||3.12|-3.67|0.8731
72619968|NCT00553475|144770999|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.16||||0.6337||95.0|-3.62|5.94|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||5.94|-3.62|0.6337
72370383|NCT02093819|144251426|SUPERIORITY_OR_OTHER||Slope|0.9603|STANDARD_ERROR_OF_MEAN|0.0838|||TWO_SIDED|90.0|0.8174|1.1032|||||Evaluation of dose proportionality - dose groups 50 mg to 600 mg. Number of subjects included in the analysis 28.|A power model was used to describe functional relationship between dose and Pk parameters. For the evaluation of dose proportionality,slope parameter (B), a two-sided 90% confidence interval of the slope was calculated. Perfect dose proportionality would correspond to a slope of 1.||1.1032|0.8174|
72452310|NCT02307682|144427684|OTHER|Treatment difference|Least Squares Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.94|||TWO_SIDED|95.0|-2.4|1.3||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 32||1.3|-2.4|
72452311|NCT02307682|144427684|OTHER|Treatment difference|Least Squares Mean Difference|0.6|STANDARD_ERROR_OF_MEAN|0.94|||TWO_SIDED|95.0|-1.2|2.5||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 32||2.5|-1.2|
72452312|NCT02307682|144427684|OTHER|Treatment difference|Least Squares Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.94|||TWO_SIDED|95.0|-2.9|0.8||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 36||0.8|-2.9|
72452313|NCT02307682|144427684|OTHER|Treatment difference|Least Squares Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.95|||TWO_SIDED|95.0|-2.1|1.6||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 36||1.6|-2.1|
72452314|NCT02307682|144427684|OTHER|Treatment difference|Least Squares Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.98|||TWO_SIDED|95.0|-2.2|1.6||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 40||1.6|-2.2|
72452315|NCT02307682|144427684|OTHER|Treatment difference|Least Squares Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|1.0|||TWO_SIDED|95.0|-1.9|2.1||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 40||2.1|-1.9|
72452316|NCT02307682|144427684|OTHER|Treatment difference|Least Squares Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|1.0|||TWO_SIDED|95.0|-2.1|1.9||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 44||1.9|-2.1|
72452317|NCT02307682|144427684|OTHER|Treatment difference|Least Squares Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|1.0|||TWO_SIDED|95.0|-1.8|2.2||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 44||2.2|-1.8|
72452318|NCT02307682|144427684|OTHER|Treatment difference|Least Squares Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.98|||TWO_SIDED|95.0|-2.5|1.3||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 48||1.3|-2.5|
72452319|NCT02307682|144427684|OTHER|Treatment difference|Least Squares Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|1.0|||TWO_SIDED|95.0|-2.1|1.8||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 48||1.8|-2.1|
72452320|NCT02307682|144427684|OTHER|Treatment difference|Least Squares Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|1.03|||TWO_SIDED|95.0|-2.2|1.8||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 52||1.8|-2.2|
72452321|NCT02307682|144427684|OTHER|Treatment difference|Least Squares Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|1.04|||TWO_SIDED|95.0|-2.2|1.9||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 52||1.9|-2.2|
72452322|NCT02307682|144427684|OTHER|Treatment difference|Least Squares Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|1.0|||TWO_SIDED|95.0|-2.5|1.5||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 56||1.5|-2.5|
72452323|NCT02307682|144427684|OTHER|Treatment difference|Least Squares Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|1.03|||TWO_SIDED|95.0|-2.7|1.4||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 56||1.4|-2.7|
72452324|NCT02307682|144427684|OTHER|Treatment difference|Least Squares Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|1.03|||TWO_SIDED|95.0|-2.1|1.9||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 60||1.9|-2.1|
72619969|NCT00553475|144771000|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.1||||0.4398||95.0|-7.44|3.24|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||3.24|-7.44|0.4398
72452325|NCT02307682|144427684|OTHER|Treatment difference|Least Squares Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|1.04|||TWO_SIDED|95.0|-2.2|1.9||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 60||1.9|-2.2|
72619970|NCT00553475|144771000|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.41||||0.9153||95.0|-7.96|7.14|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||7.14|-7.96|0.9153
72452326|NCT02307682|144427684|OTHER|Treatment difference|Least Squares Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|1.04|||TWO_SIDED|95.0|-2.3|1.7||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 64||1.7|-2.3|
72452327|NCT02307682|144427684|OTHER|Treatment difference|Least Squares Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|1.05|||TWO_SIDED|95.0|-2.2|1.9||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 64||1.9|-2.2|
72452328|NCT02307682|144427684|OTHER|Treatment difference|Least Squares Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|1.04|||TWO_SIDED|95.0|-2.1|2.0||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 68||2.0|-2.1|
72452329|NCT02307682|144427684|OTHER|Treatment difference|Least Squares Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|1.05|||TWO_SIDED|95.0|-2.2|1.9||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 68||1.9|-2.2|
72452330|NCT02307682|144427684|OTHER|Treatment difference|Least Squares Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|1.08|||TWO_SIDED|95.0|-2.0|2.3||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 72||2.3|-2.0|
72452331|NCT02307682|144427684|OTHER|Treatment difference|Least Squares Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|1.07|||TWO_SIDED|95.0|-2.4|1.8||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 72||1.8|-2.4|
72452332|NCT02307682|144427684|OTHER|Treatment difference|Least Squares Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|1.07|||TWO_SIDED|95.0|-1.8|2.4||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 76||2.4|-1.8|
72452333|NCT02307682|144427684|OTHER|Treatment difference|Least Squares Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|1.06|||TWO_SIDED|95.0|-2.1|2.1||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 76||2.1|-2.1|
72452334|NCT02307682|144427684|OTHER|Treatment difference|Least Squares Mean Difference|0.6|STANDARD_ERROR_OF_MEAN|1.07|||TWO_SIDED|95.0|-1.5|2.7||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 80||2.7|-1.5|
72452335|NCT02307682|144427684|OTHER|Treatment difference|Least Squares Mean Difference|0.7|STANDARD_ERROR_OF_MEAN|1.08|||TWO_SIDED|95.0|-1.4|2.8||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 80||2.8|-1.4|
72452336|NCT02307682|144427684|OTHER|Treatment difference|Least Squares Mean Difference|0.6|STANDARD_ERROR_OF_MEAN|1.08|||TWO_SIDED|95.0|-1.5|2.7||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 84||2.7|-1.5|
72452337|NCT02307682|144427684|OTHER|Treatment difference|Least Squares Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|1.06|||TWO_SIDED|95.0|-1.8|2.4||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 84||2.4|-1.8|
72452338|NCT02307682|144427684|OTHER|Treatment difference|Least Squares Mean Difference|0.4|STANDARD_ERROR_OF_MEAN|1.1|||TWO_SIDED|95.0|-1.8|2.5||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 88||2.5|-1.8|
72452339|NCT02307682|144427684|OTHER|Treatment difference|Least Squares Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|1.1|||TWO_SIDED|95.0|-1.9|2.4||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 88||2.4|-1.9|
72452340|NCT02307682|144427684|OTHER|Treatment difference|Least Squares Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|1.1|||TWO_SIDED|95.0|-1.9|2.5||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 92||2.5|-1.9|
72619971|NCT00553475|144771001|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.5||||0.4873||95.0|-2.75|5.76|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||5.76|-2.75|0.4873
72619972|NCT00553475|144771001|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.56||||0.4008||95.0|-3.42|8.53|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||8.53|-3.42|0.4008
72619973|NCT00553475|144771002|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.98||||0.5372||95.0|-2.13|4.09|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||4.09|-2.13|0.5372
72452341|NCT02307682|144427684|OTHER|Treatment difference|Least Squares Mean Difference|0.4|STANDARD_ERROR_OF_MEAN|1.09|||TWO_SIDED|95.0|-1.8|2.5||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 92||2.5|-1.8|
72452342|NCT02307682|144427684|OTHER|Treatment difference|Least Squares Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|1.12|||TWO_SIDED|95.0|-1.9|2.5||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 96||2.5|-1.9|
72452343|NCT02307682|144427684|OTHER|Treatment difference|Least Squares Mean Difference|0.5|STANDARD_ERROR_OF_MEAN|1.1|||TWO_SIDED|95.0|-1.6|2.7||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 96||2.7|-1.6|
72452344|NCT02307682|144427685|OTHER|Treatment difference|Least Squares Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.76|||TWO_SIDED|95.0|-1.9|1.1||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 4 to Week 48||1.1|-1.9|
72452345|NCT02307682|144427685|OTHER|Treatment difference|Least Squares Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.8|||TWO_SIDED|95.0|-1.5|1.6||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 4 to Week 48||1.6|-1.5|
72452346|NCT02307682|144427685|OTHER|Treatment difference|Least Squares Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.87|||TWO_SIDED|95.0|-1.8|1.6||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 4 to Week 96||1.6|-1.8|
72452347|NCT02307682|144427685|OTHER|Treatment difference|Least Squares Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.88|||TWO_SIDED|95.0|-1.7|1.8||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 4 to Week 96||1.8|-1.7|
72452348|NCT02307682|144427686|OTHER|Treatment difference|Least Squares Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.83|||TWO_SIDED|95.0|-2.0|1.2||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 12 to Week 48||1.2|-2.0|
72452349|NCT02307682|144427686|OTHER|Treatment difference|Least Squares Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.85|||TWO_SIDED|95.0|-1.6|1.8||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 12 to Week 48||1.8|-1.6|
72452350|NCT02307682|144427686|OTHER|Treatment difference|Least Squares Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.91|||TWO_SIDED|95.0|-1.9|1.7||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 12 to Week 96||1.7|-1.9|
72452351|NCT02307682|144427686|OTHER|Treatment difference|Least Squares Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.92|||TWO_SIDED|95.0|-1.7|1.9||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 12 to Week 96||1.9|-1.7|
72452352|NCT02307682|144427687|OTHER|Treatment difference|Least Squares Mean Difference|0.4|STANDARD_ERROR_OF_MEAN|1.08|||TWO_SIDED|95.0|-1.7|2.5||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|||2.5|-1.7|
72452353|NCT02307682|144427687|OTHER|Treatment difference|Least Squares Mean Difference|0.4|STANDARD_ERROR_OF_MEAN|1.06|||TWO_SIDED|95.0|-1.7|2.5||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|||2.5|-1.7|
72452354|NCT02307682|144427688|OTHER||Difference in proportions|-0.2|||||TWO_SIDED|95.0|-4.2|4.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 4||4.2|-4.2|
72452355|NCT02307682|144427688|OTHER||Difference in proportions|1.6|||||TWO_SIDED|95.0|-2.8|5.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 4||5.8|-2.8|
72499273|NCT03293654|144529089|EQUIVALENCE|Two treatments are judged not to be different from one another if the 90% CI of the ratio of a log-transformed exposure measure (AUC) falls completely within the range 0.80-1.25. The PK parameter AUC\[0-∞\] was log-transformed (base e) prior to analysis and was analysed using an ANCOVA model. The model included treatment as a fixed effect and body weight as a covariate.|Ratio of GLSM|0.986|STANDARD_DEVIATION|0.05|||TWO_SIDED|90.0|0.903|1.08|||||MB02: EU Avastin|||1.08|0.903|
72452356|NCT02307682|144427688|OTHER||Difference in proportions|0.8|||||TWO_SIDED|95.0|-4.4|5.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 8||5.9|-4.4|
72452357|NCT02307682|144427688|OTHER||Difference in proportions|4.2|||||TWO_SIDED|95.0|-1.2|10.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 8||10.0|-1.2|
72452358|NCT02307682|144427688|OTHER||Difference in proportions|0.2|||||TWO_SIDED|95.0|-5.9|5.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 12||5.9|-5.9|
72499274|NCT03293654|144529089|EQUIVALENCE|Two treatments are judged not to be different from one another if the 90% CI of the ratio of a log-transformed exposure measure (AUC) falls completely within the range 0.80-1.25. The PK parameter AUC\[0-∞\] was log-transformed (base e) prior to analysis and was analysed using an ANCOVA model. The model included treatment as a fixed effect and body weight as a covariate.|Ratio of GLSM|1.1|STANDARD_DEVIATION|0.05|||TWO_SIDED|90.0|1.01|1.19|||||MB02: US Avastin|||1.19|1.01|
72619974|NCT00553475|144771002|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.09||||0.348||95.0|-2.29|6.47|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||6.47|-2.29|0.3480
72452359|NCT02307682|144427688|OTHER||Difference in proportions|4.9|||||TWO_SIDED|95.0|-0.5|11.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 12||11.0|-0.5|
72499275|NCT03293654|144529089|EQUIVALENCE|Two treatments are judged not to be different from one another if the 90% CI of the ratio of a log-transformed exposure measure (AUC) falls completely within the range 0.80-1.25. The PK parameter AUC\[0-∞\] was log-transformed (base e) prior to analysis and was analysed using an ANCOVA model. The model included treatment as a fixed effect and body weight as a covariate.|Ratio of GLSM|1.12|STANDARD_DEVIATION|0.05|||TWO_SIDED|90.0|1.02|1.22|||||EU Avastin: US Avastin|||1.22|1.02|
72452360|NCT02307682|144427688|OTHER||Difference in proportions|2.3|||||TWO_SIDED|95.0|-3.7|8.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 16||8.0|-3.7|
72452361|NCT02307682|144427688|OTHER||Difference in proportions|2.3|||||TWO_SIDED|95.0|-3.8|8.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 16||8.3|-3.8|
72452362|NCT02307682|144427688|OTHER||Difference in proportions|0.3|||||TWO_SIDED|95.0|-5.9|6.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 20||6.1|-5.9|
72499276|NCT03093402|144529097|SUPERIORITY|The fixed effects included treatment, time, time² , time- and time² by treatment interactions. The Screening FSS score and the Screening 7-day average maximum daily pain NRS were included as covariates. Within-subject random effects for intercept and slopes for time and time² were fit using an unstructured covariance matrix, assuming a different structure for placebo and pooled active treatment groups.|Median Difference (Final Values)|-0.9||||0.419|TWO_SIDED|95.0|-2.5|0.6||This p-value is from the overall 3 degree of freedom test that simultaneously compares the estimated mean change from Day 1 to Day 84 for each of the 3 active treatment arms versus placebo.|Mixed Models Analysis||Mean difference in the change from Day 1 to Day 84 for High JBT-101 - Placebo. The estimated mean change (95% confidence interval) from Day 1 to Day 84 for Placebo was -0.3 (-1.5, 0.9).|The null hypothesis is that linear trends from Day 1 to Day 84 are equivalent for each active JBT-101 cohort and placebo. The overall test is a 3 degree of freedom F test that simultaneously compares the estimated mean change from Day 1 to Day 84 for each of the 3 active JBT-101 cohorts versus placebo.||0.6|-2.5|0.4190
72619975|NCT00553475|144771003|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.06||||0.0544||95.0|-0.1|10.21|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||10.21|-0.10|0.0544
72619976|NCT00553475|144771003|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|8.15||||0.0278||95.0|0.89|15.42|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||15.42|0.89|0.0278
72452363|NCT02307682|144427688|OTHER||Difference in proportions|3.8|||||TWO_SIDED|95.0|-2.4|9.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 20||9.9|-2.4|
72452364|NCT02307682|144427688|OTHER||Difference in proportions|1.9|||||TWO_SIDED|95.0|-4.2|7.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 24||7.3|-4.2|
72619977|NCT00553475|144771004|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.92||||0.7394||95.0|-4.52|6.37|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||6.37|-4.52|0.7394
72619978|NCT00553475|144771004|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.22||||0.5712||95.0|-5.49|9.93|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||9.93|-5.49|0.5712
72619979|NCT00553475|144771005|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.67||||0.0058||95.0|-1.14|-0.19|||ANCOVA|Treatment groups as factors and baseline values as covariates||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.19|-1.14|0.0058
72619980|NCT00553475|144771005|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.64||||0.0333||95.0|-1.23|-0.05|||ANCOVA|Treatment groups as factors and baseline values as covariates||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.05|-1.23|0.0333
72452365|NCT02307682|144427688|OTHER||Difference in proportions|7.2|||||TWO_SIDED|95.0|0.8|13.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 24||13.4|0.8|
72452366|NCT02307682|144427688|OTHER||Difference in proportions|2.3|||||TWO_SIDED|95.0|-4.3|8.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 28||8.5|-4.3|
72452367|NCT02307682|144427688|OTHER||Difference in proportions|3.2|||||TWO_SIDED|95.0|-3.4|9.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 28||9.4|-3.4|
72452368|NCT02307682|144427688|OTHER||Difference in proportions|1.2|||||TWO_SIDED|95.0|-5.0|7.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 32||7.2|-5.0|
72452369|NCT02307682|144427688|OTHER||Difference in proportions|7.9|||||TWO_SIDED|95.0|1.5|14.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 32||14.4|1.5|
72452370|NCT02307682|144427688|OTHER||Difference in proportions|1.0|||||TWO_SIDED|95.0|-5.4|7.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 36||7.0|-5.4|
72452371|NCT02307682|144427688|OTHER||Difference in proportions|8.1|||||TWO_SIDED|95.0|2.1|14.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 36||14.5|2.1|
72452372|NCT02307682|144427688|OTHER||Difference in proportions|1.5|||||TWO_SIDED|95.0|-4.4|8.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 40||8.1|-4.4|
72452373|NCT02307682|144427688|OTHER||Difference in proportions|8.3|||||TWO_SIDED|95.0|2.0|15.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 40||15.1|2.0|
72452374|NCT02307682|144427688|OTHER||Difference in proportions|1.0|||||TWO_SIDED|95.0|-5.2|7.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 44||7.1|-5.2|
72370384|NCT01708902|144251469|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.22|STANDARD_ERROR_OF_MEAN|0.12||0.0587|TWO_SIDED|95.0|-0.45|0.01|||ANCOVA||The adjusted mean difference was calculated as the adjusted mean of 'Main: Linagliptin 2.5mg / Metformin 1000mg BID' minus 'Main: Metformin 1000mg BID'.|"The model includes treatment as a fixed effect and baseline HbA1c as a linear covariate.~The null and alternative hypotheses were tested in a hierarchical sequence. The next null hypothesis was tested in a confirmatory way only if all prior null-hypotheses were rejected. 'Greater effect' refers to a greater reduction in HbA1c."||0.01|-0.45|0.0587
72452375|NCT02307682|144427688|OTHER||Difference in proportions|7.6|||||TWO_SIDED|95.0|0.7|13.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 44||13.8|0.7|
72452376|NCT02307682|144427688|OTHER||Difference in proportions|-0.2|||||TWO_SIDED|95.0|-6.8|6.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 48||6.1|-6.8|
72452377|NCT02307682|144427688|OTHER||Difference in proportions|8.2|||||TWO_SIDED|95.0|2.2|15.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 48||15.0|2.2|
72452378|NCT02307682|144427688|OTHER||Difference in proportions|2.8|||||TWO_SIDED|95.0|-3.9|9.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 52||9.2|-3.9|
72452379|NCT02307682|144427688|OTHER||Difference in proportions|4.8|||||TWO_SIDED|95.0|-1.5|11.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 52||11.4|-1.5|
72452380|NCT02307682|144427688|OTHER||Difference in proportions|0.8|||||TWO_SIDED|95.0|-5.9|7.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 56||7.1|-5.9|
72619981|NCT00553475|144771006|SUPERIORITY_OR_OTHER_LEGACY|||||||0.153||95.0|||||Cochran-Mantel-Haenszel|stratified by CLcr stratum||Significance level of 0.05 was used.||||0.153
72452381|NCT02307682|144427688|OTHER||Difference in proportions|3.0|||||TWO_SIDED|95.0|-3.1|9.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 56||9.7|-3.1|
72452382|NCT02307682|144427688|OTHER||Difference in proportions|-0.3|||||TWO_SIDED|95.0|-6.5|6.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 60||6.5|-6.5|
72452383|NCT02307682|144427688|OTHER||Difference in proportions|4.9|||||TWO_SIDED|95.0|-1.3|11.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 60||11.4|-1.3|
72452384|NCT02307682|144427688|OTHER||Difference in proportions|3.7|||||TWO_SIDED|95.0|-2.9|10.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 64||10.2|-2.9|
72452385|NCT02307682|144427688|OTHER||Difference in proportions|5.8|||||TWO_SIDED|95.0|-0.4|12.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 64||12.3|-0.4|
72452386|NCT02307682|144427688|OTHER||Difference in proportions|2.4|||||TWO_SIDED|95.0|-4.2|9.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 68||9.0|-4.2|
72452387|NCT02307682|144427688|OTHER||Difference in proportions|5.6|||||TWO_SIDED|95.0|-0.2|11.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 68||11.9|-0.2|
72452388|NCT02307682|144427688|OTHER||Difference in proportions|3.8|||||TWO_SIDED|95.0|-3.0|9.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 72||9.9|-3.0|
72452389|NCT02307682|144427688|OTHER||Difference in proportions|5.1|||||TWO_SIDED|95.0|-1.1|11.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 72||11.4|-1.1|
72619982|NCT00553475|144771006|SUPERIORITY_OR_OTHER_LEGACY|||||||0.059||95.0|||||Cochran-Mantel-Haenszel|stratified by CLcr stratum||Significance level of 0.05 was used.||||0.059
72619983|NCT00553475|144771007|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.43||||0.0287||95.0|-0.82|-0.05|||Mixed Model Repeated Measures Analysis|Model included treatment, CLcr stratum, week and treatment-by-week interaction, and baseline scores as fixed effects, and subject as a random effect.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.05|-0.82|0.0287
72452390|NCT02307682|144427688|OTHER||Difference in proportions|6.0|||||TWO_SIDED|95.0|-1.5|12.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 76||12.8|-1.5|
72452391|NCT02307682|144427688|OTHER||Difference in proportions|5.0|||||TWO_SIDED|95.0|-1.0|11.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 76||11.6|-1.0|
72452392|NCT02307682|144427688|OTHER||Difference in proportions|1.7|||||TWO_SIDED|95.0|-5.1|8.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 80||8.6|-5.1|
72452393|NCT02307682|144427688|OTHER||Difference in proportions|8.8|||||TWO_SIDED|95.0|2.7|15.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 80||15.4|2.7|
72452394|NCT02307682|144427688|OTHER||Difference in proportions|3.3|||||TWO_SIDED|95.0|-3.7|9.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 84||9.4|-3.7|
72452395|NCT02307682|144427688|OTHER||Difference in proportions|4.2|||||TWO_SIDED|95.0|-2.2|10.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 84||10.3|-2.2|
72619984|NCT00553475|144771007|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-0.75||||0.0073||95.0|-1.29|-0.2|||Mixed Model Repeated Measures Analysis|Model included treatment, CLcr stratum, week and treatment-by-week interaction, and baseline scores as fixed effects, and subject as a random effect.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.20|-1.29|0.0073
72452396|NCT02307682|144427688|OTHER||Difference in proportions|4.1|||||TWO_SIDED|95.0|-3.0|10.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 88||10.9|-3.0|
72499277|NCT03093402|144529097|SUPERIORITY|The fixed effects included treatment, time, time² , time- and time² by treatment interactions. The Screening FSS score and the Screening 7-day average maximum daily pain NRS were included as covariates. Within-subject random effects for intercept and slopes for time and time² were fit using an unstructured covariance matrix, assuming a different structure for placebo and pooled active treatment groups.|Median Difference (Final Values)|-1.2||||0.419|TWO_SIDED|95.0|-2.7|0.3||This p-value is from the overall 3 degree of freedom test that simultaneously compares the estimated mean change from Day 1 to Day 84 for each of the 3 active treatment arms versus placebo.|Mixed Models Analysis||Mean difference in the change from Day 1 to Day 84 for Medium JBT-101 - Placebo. The estimated mean change (95% confidence interval) from Day 1 to Day 84 for Placebo was -0.3 (-1.5, 0.9).|The null hypothesis is that linear trends from Day 1 to Day 84 are equivalent for each active JBT-101 cohort and placebo. The overall test is a 3 degree of freedom F test that simultaneously compares the estimated mean change from Day 1 to Day 84 for each of the 3 active JBT-101 cohorts versus placebo.||0.3|-2.7|0.4190
72499278|NCT03093402|144529097|SUPERIORITY|The fixed effects included treatment, time, time² , time- and time² by treatment interactions. The Screening FSS score and the Screening 7-day average maximum daily pain NRS were included as covariates. Within-subject random effects for intercept and slopes for time and time² were fit using an unstructured covariance matrix, assuming a different structure for placebo and pooled active treatment groups.|Mean Difference (Final Values)|-0.7||||0.419|TWO_SIDED|95.0|-2.2|0.8||This p-value is from the overall 3 degree of freedom test that simultaneously compares the estimated mean change from Day 1 to Day 84 for each of the 3 active treatment arms versus placebo.|Mixed Models Analysis||Mean difference in the change from Day 1 to Day 84 for Low JBT-101 - Placebo. The estimated mean change (95% confidence interval) from Day 1 to Day 84 for Placebo was -0.3 (-1.5, 0.9).|The null hypothesis is that linear trends from Day 1 to Day 84 are equivalent for each active JBT-101 cohort and placebo. The overall test is a 3 degree of freedom F test that simultaneously compares the estimated mean change from Day 1 to Day 84 for each of the 3 active JBT-101 cohorts versus placebo.||0.8|-2.2|0.4190
72499279|NCT03093402|144529107|SUPERIORITY|||||||0.594|||||||Mixed Models Analysis|||The dichotomous outcome is modeled using the generalized estimating equations approach under the binomial distribution with a logit link. The model includes fixed effects for visit, treatment and visit\*treatment interaction with an unstructured within-subject correlation structure across visits. The overall test p-value is a 3 degree-of-freedom test comparing each active treatment vs. placebo at Day 29.||||0.594
72499280|NCT03093402|144529107|SUPERIORITY|||||||0.487|||||||Mixed Models Analysis|||The dichotomous outcome is modeled using the generalized estimating equations approach under the binomial distribution with a logit link. The model includes fixed effects for visit, treatment and visit\*treatment interaction with an unstructured within-subject correlation structure across visits. The overall test p-value is a 3 degree-of-freedom test comparing each active treatment vs. placebo at Day 57.||||0.487
72499281|NCT03093402|144529107|SUPERIORITY|||||||0.76|||||||Mixed Models Analysis|||The dichotomous outcome is modeled using the generalized estimating equations approach under the binomial distribution with a logit link. The model includes fixed effects for visit, treatment and visit\*treatment interaction with an unstructured within-subject correlation structure across visits. The overall test p-value is a 3 degree-of-freedom test comparing each active treatment vs. placebo at Day 85.||||0.760
72499282|NCT03093402|144529107|SUPERIORITY|||||||0.676|||||||Mixed Models Analysis|||The dichotomous outcome is modeled using the generalized estimating equations approach under the binomial distribution with a logit link. The model includes fixed effects for visit, treatment and visit\*treatment interaction with an unstructured within-subject correlation structure across visits. The overall test p-value is a 3 degree-of-freedom test comparing each active treatment vs. placebo at Day 113.||||0.676
72562194|NCT02459418|144655740|EQUIVALENCE|The 90% CIs of the ratios of geometric means of log-transformed baseline corrected Cmax were used to assess bioequivalence between Gonal-f® RFF and AFOLIA using the bioequivalence interval of 80.00% to 125.00%.|Geometric LS Mean Ratio|123.15|||||TWO_SIDED|90.0|108.12|140.28||||||An ANOVA model with sequence, treatment and period as fixed effects, and subject nested within sequence as random effect was used. LS means and 90% CIs for treatment differences on log-scale were obtained and back-transformed to provide geometric LS mean ratios of AFOLIA over Gonal-f® RFF.||140.28|108.12|
72619985|NCT00553475|144771008|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.61||||0.0021||95.0|-1.0|-0.22|||Mixed Model Repeated Measures Analysis|Model included treatment, CLcr stratum, week and treatment-by-week interaction, and baseline scores as fixed effects, and subject as a random effect.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.22|-1.00|0.0021
72499283|NCT03093402|144529108|SUPERIORITY|||||||0.796||||||This p-value is from an exact likelihood ratio test at Day 29 testing that the proportion of subjects with \>= 50% improvement is equal among the 4 treatment groups.|Exact Likelihood Ratio Test|||||||0.796
72619986|NCT00553475|144771008|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.23|||<|0.0001||95.0|-1.78|-0.69|||Mixed Model Repeated Measures Analysis|Model included treatment, CLcr stratum, week and treatment-by-week interaction, and baseline scores as fixed effects, and subject as a random effect.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.69|-1.78|<0.0001
72619987|NCT00553475|144771009|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.6||||0.0026||95.0|-0.99|-0.21|||Mixed Model Repeated Measures Analysis|Model included treatment, CLcr stratum, week and treatment-by-week interaction, and baseline scores as fixed effects, and subject as a random effect.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.21|-0.99|0.0026
72452397|NCT02307682|144427688|OTHER||Difference in proportions|8.0|||||TWO_SIDED|95.0|1.9|14.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 88||14.6|1.9|
72619988|NCT00553475|144771009|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.13|||<|0.0001||95.0|-1.69|-0.58|||Mixed Model Repeated Measures Analysis|Model included treatment, CLcr stratum, week and treatment-by-week interaction, and baseline scores as fixed effects, and subject as a random effect.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.58|-1.69|<0.0001
72562195|NCT02459418|144655741|EQUIVALENCE|The 90% CIs of the ratios of geometric means of log-transformed baseline corrected AUC(0-∞) were used to assess bioequivalence between Gonal-f® RFF and AFOLIA using the bioequivalence interval of 80.00% to 125.00%.|Geometric LS mean ratio|133.68|||||TWO_SIDED|90.0|102.42|174.49||||||An ANOVA model with sequence, treatment and period as fixed effects, and subject nested within sequence as random effect was used. LS means and 90% CIs for treatment differences on log-scale were obtained and back-transformed to provide geometric LS mean ratios of AFOLIA over Gonal-f® RFF.||174.49|102.42|
72619989|NCT00553475|144771010|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.64||||0.0012||95.0|-1.03|-0.25|||Mixed Model Repeated Measures Analysis|Model included treatment, CLcr stratum, week and treatment-by-week interaction, and baseline scores as fixed effects, and subject as a random effect.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.25|-1.03|0.0012
72452398|NCT02307682|144427688|OTHER||Difference in proportions|1.6|||||TWO_SIDED|95.0|-5.1|8.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 92||8.3|-5.1|
72452399|NCT02307682|144427688|OTHER||Difference in proportions|5.9|||||TWO_SIDED|95.0|0.0|12.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 92||12.5|-0.0|
72452400|NCT02307682|144427688|OTHER||Difference in proportions|5.5|||||TWO_SIDED|95.0|-1.2|12.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 96||12.3|-1.2|
72452401|NCT02307682|144427688|OTHER||Difference in proportions|7.2|||||TWO_SIDED|95.0|1.4|13.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 96||13.8|1.4|
72452402|NCT02307682|144427689|OTHER||Difference in proportions|1.3|||||TWO_SIDED|95.0|-4.3|6.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 4||6.9|-4.3|
72452403|NCT02307682|144427689|OTHER||Difference in proportions|6.3|||||TWO_SIDED|95.0|0.6|12.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 4||12.2|0.6|
72452404|NCT02307682|144427689|OTHER||Difference in proportions|0.3|||||TWO_SIDED|95.0|-6.6|6.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 8||6.7|-6.6|
72452405|NCT02307682|144427689|OTHER||Difference in proportions|1.7|||||TWO_SIDED|95.0|-4.7|8.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 8||8.0|-4.7|
72452406|NCT02307682|144427689|OTHER||Difference in proportions|0.5|||||TWO_SIDED|95.0|-6.2|7.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 12||7.1|-6.2|
72619990|NCT00553475|144771010|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.11|||<|0.0001||95.0|-1.67|-0.56|||Mixed Model Repeated Measures Analysis|Model included treatment, CLcr stratum, week and treatment-by-week interaction, and baseline scores as fixed effects, and subject as a random effect.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.56|-1.67|<0.0001
72452407|NCT02307682|144427689|OTHER||Difference in proportions|6.0|||||TWO_SIDED|95.0|-0.8|12.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 12||12.7|-0.8|
72452408|NCT02307682|144427689|OTHER||Difference in proportions|1.0|||||TWO_SIDED|95.0|-6.0|7.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 16||7.7|-6.0|
72452409|NCT02307682|144427689|OTHER||Difference in proportions|5.6|||||TWO_SIDED|95.0|-1.5|12.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 16||12.2|-1.5|
72452410|NCT02307682|144427689|OTHER||Difference in proportions|0.3|||||TWO_SIDED|95.0|-6.5|7.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 20||7.0|-6.5|
72619991|NCT00553475|144771011|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.65||||0.0011||95.0|-1.04|-0.26|||Mixed Model Repeated Measures Analysis|Model included treatment, CLcr stratum, week and treatment-by-week interaction, and baseline scores as fixed effects, and subject as a random effect.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.26|-1.04|0.0011
72619992|NCT00553475|144771011|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.16|||<|0.0001||95.0|-1.72|-0.6|||Mixed Model Repeated Measures Analysis|Model included treatment, CLcr stratum, week and treatment-by-week interaction, and baseline scores as fixed effects, and subject as a random effect.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.60|-1.72|<0.0001
72452411|NCT02307682|144427689|OTHER||Difference in proportions|5.2|||||TWO_SIDED|95.0|-1.8|12.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 20||12.2|-1.8|
72452412|NCT02307682|144427689|OTHER||Difference in proportions|2.5|||||TWO_SIDED|95.0|-4.0|9.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 24||9.5|-4.0|
72452413|NCT02307682|144427689|OTHER||Difference in proportions|3.8|||||TWO_SIDED|95.0|-3.5|11.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 24||11.3|-3.5|
72499284|NCT03093402|144529108|SUPERIORITY|||||||0.955||||||This p-value is from an exact likelihood ratio test at Day 57 testing that the proportion of subjects with \>= 50% improvement is equal among the 4 treatment groups.|Exact Likelihood Ratio Test|||||||0.955
72452414|NCT02307682|144427689|OTHER||Difference in proportions|1.2|||||TWO_SIDED|95.0|-5.9|8.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 28||8.2|-5.9|
72452415|NCT02307682|144427689|OTHER||Difference in proportions|3.9|||||TWO_SIDED|95.0|-3.4|11.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 28||11.2|-3.4|
72452416|NCT02307682|144427689|OTHER||Difference in proportions|-1.6|||||TWO_SIDED|95.0|-8.2|5.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 32||5.9|-8.2|
72452417|NCT02307682|144427689|OTHER||Difference in proportions|3.6|||||TWO_SIDED|95.0|-3.2|10.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 32||10.5|-3.2|
72452418|NCT02307682|144427689|OTHER||Difference in proportions|-0.1|||||TWO_SIDED|95.0|-7.3|6.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 36||6.8|-7.3|
72452419|NCT02307682|144427689|OTHER||Difference in proportions|1.9|||||TWO_SIDED|95.0|-5.2|8.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 36||8.6|-5.2|
72452420|NCT02307682|144427689|OTHER||Difference in proportions|-0.9|||||TWO_SIDED|95.0|-7.8|6.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 40||6.6|-7.8|
72499285|NCT03093402|144529108|SUPERIORITY|||||||0.211||||||This p-value is from an exact likelihood ratio test at Day 85 testing that the proportion of subjects with \>= 50% improvement is equal among the 4 treatment groups.|Exact Likelihood Ratio Test|||||||0.211
72499286|NCT03093402|144529108|SUPERIORITY|||||||0.481||||||This p-value is from an exact likelihood ratio test at Day 113 testing that the proportion of subjects with \>= 50% improvement is equal among the 4 treatment groups.|Exact Likelihood Ratio Test|||||||0.481
72619993|NCT00553475|144771012|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.79|||<|0.0001||95.0|-1.18|-0.4|||Mixed Model Repeated Measures Analysis|Model included treatment, CLcr stratum, week and treatment-by-week interaction, and baseline scores as fixed effects, and subject as a random effect.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.40|-1.18|<0.0001
72619994|NCT00553475|144771012|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.12|||<|0.0001||95.0|-1.68|-0.56|||Mixed Model Repeated Measures Analysis|Model included treatment, CLcr stratum, week and treatment-by-week interaction, and baseline scores as fixed effects, and subject as a random effect.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.56|-1.68|<0.0001
72619995|NCT00553475|144771013|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.72||||0.0003||95.0|-1.12|-0.33|||Mixed Model Repeated Measures Analysis|Model included treatment, CLcr stratum, week and treatment-by-week interaction, and baseline scores as fixed effects, and subject as a random effect.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.33|-1.12|0.0003
72619996|NCT00553475|144771013|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.09||||0.0002||95.0|-1.66|-0.52|||Mixed Model Repeated Measures Analysis|Model included treatment, CLcr stratum, week and treatment-by-week interaction, and baseline scores as fixed effects, and subject as a random effect.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.52|-1.66|0.0002
72619997|NCT00553475|144771014|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.67||||0.0008||95.0|-1.07|-0.28|||Mixed Model Repeated Measures Analysis|Model included treatment, CLcr stratum, week and treatment-by-week interaction, and baseline scores as fixed effects, and subject as a random effect.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.28|-1.07|0.0008
72619998|NCT00553475|144771014|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.94||||0.0014||95.0|-1.51|-0.36|||Mixed Model Repeated Measures Analysis|Model included treatment, CLcr stratum, week and treatment-by-week interaction, and baseline scores as fixed effects, and subject as a random effect.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.36|-1.51|0.0014
72619999|NCT00553475|144771015|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.73||||0.0003||95.0|-1.12|-0.33|||Mixed Model Repeated Measures Analysis|Model included treatment, CLcr stratum, week and treatment-by-week interaction, and baseline scores as fixed effects, and subject as a random effect.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.33|-1.12|0.0003
72620000|NCT00553475|144771015|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.86||||0.0036||95.0|-1.44|-0.28|||Mixed Model Repeated Measures Analysis|Model included treatment, CLcr stratum, week and treatment-by-week interaction, and baseline scores as fixed effects, and subject as a random effect.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.28|-1.44|0.0036
72620001|NCT00553475|144771016|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.7||||0.0005||95.0|-1.1|-0.31|||Mixed Model Repeated Measures Analysis|Model included treatment, CLcr stratum, week and treatment-by-week interaction, and baseline scores as fixed effects, and subject as a random effect.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.31|-1.10|0.0005
72620002|NCT00553475|144771016|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.87||||0.0034||95.0|-1.46|-0.29|||Mixed Model Repeated Measures Analysis|Model included treatment, CLcr stratum, week and treatment-by-week interaction, and baseline scores as fixed effects, and subject as a random effect.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.29|-1.46|0.0034
72620003|NCT00553475|144771017|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.62||||0.0023||95.0|-1.02|-0.22|||Mixed Model Repeated Measures Analysis|Model included treatment, CLcr stratum, week and treatment-by-week interaction, and baseline scores as fixed effects, and subject as a random effect.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.22|-1.02|0.0023
72620004|NCT00553475|144771017|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.77||||0.0105||95.0|-1.36|-0.18|||Mixed Model Repeated Measures Analysis|Model included treatment, CLcr stratum, week and treatment-by-week interaction, and baseline scores as fixed effects, and subject as a random effect.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.18|-1.36|0.0105
72620005|NCT00553475|144771018|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.65||||0.0016||95.0|-1.05|-0.25|||Mixed Model Repeated Measures Analysis|Model included treatment, CLcr stratum, week and treatment-by-week interaction, and baseline scores as fixed effects, and subject as a random effect.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.25|-1.05|0.0016
72620006|NCT00553475|144771018|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.77||||0.0111||95.0|-1.37|-0.18|||Mixed Model Repeated Measures Analysis|Model included treatment, CLcr stratum, week and treatment-by-week interaction, and baseline scores as fixed effects, and subject as a random effect.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.18|-1.37|0.0111
72452421|NCT02307682|144427689|OTHER||Difference in proportions|2.3|||||TWO_SIDED|95.0|-4.8|10.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 40||10.0|-4.8|
72620007|NCT00553475|144771019|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.07||||0.6118||95.0|-5.23|3.08|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||3.08|-5.23|0.6118
72452422|NCT02307682|144427689|OTHER||Difference in proportions|2.2|||||TWO_SIDED|95.0|-4.4|9.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 44||9.2|-4.4|
72620008|NCT00553475|144771019|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|7.59||||0.0109||95.0|1.76|13.42|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||13.42|1.76|0.0109
72620009|NCT00553475|144771020|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.49||||0.4602||95.0|-2.47|5.45|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||5.45|-2.47|0.4602
72452423|NCT02307682|144427689|OTHER||Difference in proportions|0.2|||||TWO_SIDED|95.0|-7.1|7.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 44||7.2|-7.1|
72452424|NCT02307682|144427689|OTHER||Difference in proportions|-1.0|||||TWO_SIDED|95.0|-7.9|6.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 48||6.2|-7.9|
72620010|NCT00553475|144771020|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.97||||0.1625||95.0|-1.61|9.54|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||9.54|-1.61|0.1625
72620011|NCT00553475|144771021|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.85|||<|0.0001||95.0|-1.25|-0.46|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.46|-1.25|<0.0001
72452425|NCT02307682|144427689|OTHER||Difference in proportions|2.4|||||TWO_SIDED|95.0|-4.5|9.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 48||9.2|-4.5|
72452426|NCT02307682|144427689|OTHER||Difference in proportions|0.5|||||TWO_SIDED|95.0|-6.8|8.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 52||8.1|-6.8|
72452427|NCT02307682|144427689|OTHER||Difference in proportions|1.2|||||TWO_SIDED|95.0|-5.8|8.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 52||8.4|-5.8|
72452428|NCT02307682|144427689|OTHER||Difference in proportions|1.0|||||TWO_SIDED|95.0|-6.1|8.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 56||8.2|-6.1|
72452429|NCT02307682|144427689|OTHER||Difference in proportions|-1.3|||||TWO_SIDED|95.0|-8.6|5.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 56||5.6|-8.6|
72452430|NCT02307682|144427689|OTHER||Difference in proportions|-0.3|||||TWO_SIDED|95.0|-7.0|7.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 60||7.1|-7.0|
72452431|NCT02307682|144427689|OTHER||Difference in proportions|3.4|||||TWO_SIDED|95.0|-3.5|11.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 60||11.0|-3.5|
72452432|NCT02307682|144427689|OTHER||Difference in proportions|4.0|||||TWO_SIDED|95.0|-3.0|10.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 64||10.8|-3.0|
72452433|NCT02307682|144427689|OTHER||Difference in proportions|5.5|||||TWO_SIDED|95.0|-1.4|13.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 64||13.0|-1.4|
72452434|NCT02307682|144427689|OTHER||Difference in proportions|2.7|||||TWO_SIDED|95.0|-4.1|9.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 68||9.5|-4.1|
72452435|NCT02307682|144427689|OTHER||Difference in proportions|2.1|||||TWO_SIDED|95.0|-4.8|9.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 68||9.7|-4.8|
72452436|NCT02307682|144427689|OTHER||Difference in proportions|5.2|||||TWO_SIDED|95.0|-1.6|12.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 72||12.3|-1.6|
72452437|NCT02307682|144427689|OTHER||Difference in proportions|1.6|||||TWO_SIDED|95.0|-5.4|8.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 72||8.6|-5.4|
72452438|NCT02307682|144427689|OTHER||Difference in proportions|2.5|||||TWO_SIDED|95.0|-4.8|9.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 76||9.4|-4.8|
72452439|NCT02307682|144427689|OTHER||Difference in proportions|1.5|||||TWO_SIDED|95.0|-5.0|8.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 76||8.2|-5.0|
72452440|NCT02307682|144427689|OTHER||Difference in proportions|-0.1|||||TWO_SIDED|95.0|-6.9|7.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 80||7.4|-6.9|
72452441|NCT02307682|144427689|OTHER||Difference in proportions|1.7|||||TWO_SIDED|95.0|-5.1|8.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 80||8.5|-5.1|
72452442|NCT02307682|144427689|OTHER||Difference in proportions|3.0|||||TWO_SIDED|95.0|-3.9|10.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 84||10.1|-3.9|
72620012|NCT00553475|144771021|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.63||||0.0273||95.0|-1.19|-0.07|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.07|-1.19|0.0273
72620013|NCT00553475|144771022|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.79||||0.0013||95.0|-2.87|-0.71|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.71|-2.87|0.0013
72620014|NCT00553475|144771022|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.13||||0.0062||95.0|-3.65|-0.61|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.61|-3.65|0.0062
72620015|NCT00553475|144771023|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.6||||0.0068||95.0|-1.03|-0.17|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.17|-1.03|0.0068
72620016|NCT00553475|144771023|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.56||||0.0707||95.0|-1.17|0.05|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||0.05|-1.17|0.0707
72452443|NCT02307682|144427689|OTHER||Difference in proportions|2.1|||||TWO_SIDED|95.0|-5.0|9.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 84||9.1|-5.0|
72452444|NCT02307682|144427689|OTHER||Difference in proportions|4.6|||||TWO_SIDED|95.0|-2.5|11.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 88||11.8|-2.5|
72452445|NCT02307682|144427689|OTHER||Difference in proportions|3.3|||||TWO_SIDED|95.0|-3.4|10.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 88||10.6|-3.4|
72452446|NCT02307682|144427689|OTHER||Difference in proportions|5.1|||||TWO_SIDED|95.0|-1.6|12.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 92||12.2|-1.6|
72452447|NCT02307682|144427689|OTHER||Difference in proportions|3.9|||||TWO_SIDED|95.0|-3.0|11.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 92||11.2|-3.0|
72452448|NCT02307682|144427689|OTHER||Difference in proportions|5.6|||||TWO_SIDED|95.0|-1.9|12.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 96||12.7|-1.9|
72452449|NCT02307682|144427689|OTHER||Difference in proportions|5.7|||||TWO_SIDED|95.0|-1.0|12.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 96||12.6|-1.0|
72452450|NCT02307682|144427690|OTHER||Difference in proportions|-0.8|||||TWO_SIDED|95.0|-7.7|6.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 4||6.0|-7.7|
72452451|NCT02307682|144427690|OTHER||Difference in proportions|1.4|||||TWO_SIDED|95.0|-5.3|8.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 4||8.7|-5.3|
72620017|NCT00553475|144771024|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.35||||0.0013||95.0|-3.76|-0.93|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.93|-3.76|0.0013
72620018|NCT00553475|144771024|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.67||||0.0087||95.0|-4.67|-0.68|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.68|-4.67|0.0087
72620019|NCT00553475|144771025|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-7.27||||0.0056||95.0|-12.4|-2.14|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-2.14|-12.40|0.0056
72620020|NCT00553475|144771025|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-7.49||||0.0427||95.0|-14.74|-0.25|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.25|-14.74|0.0427
72452452|NCT02307682|144427690|OTHER||Difference in proportions|-0.3|||||TWO_SIDED|95.0|-7.4|6.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 8||6.8|-7.4|
72452453|NCT02307682|144427690|OTHER||Difference in proportions|-1.8|||||TWO_SIDED|95.0|-8.9|5.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 8||5.3|-8.9|
72452454|NCT02307682|144427690|OTHER||Difference in proportions|-1.4|||||TWO_SIDED|95.0|-8.1|5.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 12||5.9|-8.1|
72452455|NCT02307682|144427690|OTHER||Difference in proportions|2.1|||||TWO_SIDED|95.0|-4.8|8.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 12||8.8|-4.8|
72452456|NCT02307682|144427690|OTHER||Difference in proportions|-2.4|||||TWO_SIDED|95.0|-9.8|4.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 16||4.7|-9.8|
72452457|NCT02307682|144427690|OTHER||Difference in proportions|1.5|||||TWO_SIDED|95.0|-5.3|8.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 16||8.6|-5.3|
72452458|NCT02307682|144427690|OTHER||Difference in proportions|-3.1|||||TWO_SIDED|95.0|-9.7|3.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 20||3.6|-9.7|
72452459|NCT02307682|144427690|OTHER||Difference in proportions|-4.1|||||TWO_SIDED|95.0|-11.4|3.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 20||3.3|-11.4|
72452460|NCT02307682|144427690|OTHER||Difference in proportions|-0.9|||||TWO_SIDED|95.0|-7.6|6.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 24||6.1|-7.6|
72452461|NCT02307682|144427690|OTHER||Difference in proportions|2.5|||||TWO_SIDED|95.0|-4.4|10.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 24||10.0|-4.4|
72452462|NCT02307682|144427690|OTHER||Difference in proportions|-0.2|||||TWO_SIDED|95.0|-7.2|6.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 28||6.9|-7.2|
72452463|NCT02307682|144427690|OTHER||Difference in proportions|1.1|||||TWO_SIDED|95.0|-6.3|7.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 28||7.8|-6.3|
72452464|NCT02307682|144427690|OTHER||Difference in proportions|2.0|||||TWO_SIDED|95.0|-4.7|9.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 32||9.2|-4.7|
72452465|NCT02307682|144427690|OTHER||Difference in proportions|3.1|||||TWO_SIDED|95.0|-3.9|10.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 32||10.3|-3.9|
72452466|NCT02307682|144427690|OTHER||Difference in proportions|-6.0|||||TWO_SIDED|95.0|-12.6|1.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 36||1.3|-12.6|
72452467|NCT02307682|144427690|OTHER||Difference in proportions|-5.4|||||TWO_SIDED|95.0|-12.7|1.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 36||1.9|-12.7|
72452468|NCT02307682|144427690|OTHER||Difference in proportions|-1.6|||||TWO_SIDED|95.0|-8.1|5.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 40||5.6|-8.1|
72452469|NCT02307682|144427690|OTHER||Difference in proportions|0.9|||||TWO_SIDED|95.0|-6.2|7.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 40||7.9|-6.2|
72562196|NCT02459418|144655742|OTHER||Median Difference (Net)|7.5|||||TWO_SIDED|90.0|4.5|11.5||||||Non-transformed Tmax was tested using the non-parametric Wilcoxon signed rank test to assess the differences between Gonal-f® RFF and AFOLIA. Median differences and corresponding 90% CIs were calculated using an exact Hodges-Lehmann estimate.||11.5|4.5|
72452470|NCT02307682|144427690|OTHER||Difference in proportions|-3.0|||||TWO_SIDED|95.0|-9.6|3.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 44||3.9|-9.6|
72452471|NCT02307682|144427690|OTHER||Difference in proportions|-2.0|||||TWO_SIDED|95.0|-9.1|5.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 44||5.4|-9.1|
72562197|NCT02459418|144655744|EQUIVALENCE|The 90% CIs of the ratios of geometric means of log-transformed baseline corrected AUC(0-last) were used to assess bioequivalence between Gonal-f® RFF and AFOLIA using the bioequivalence interval of 80.00% to 125.00%.|Geometric LS Mean Ratio|163.0|||||TWO_SIDED|90.0|94.0|282.67||||||An ANOVA model with sequence, treatment and period as fixed effects, and subject nested within sequence as random effect was used. LS means and 90% CIs for treatment differences on log-scale were obtained and back-transformed to provide geometric LS mean ratios of AFOLIA over Gonal-f® RFF.||282.67|94|
72562198|NCT02459418|144655745|EQUIVALENCE|The 90% CIs of the ratios of geometric means of log-transformed baseline corrected Cmax were used to assess bioequivalence between Gonal-f® RFF and AFOLIA using the bioequivalence interval of 80.00% to 125.00%.|Geometric LS Mean Ratio|177.17|||||TWO_SIDED|90.0|125.65|249.81||||||An ANOVA model with sequence, treatment and period as fixed effects, and subject nested within sequence as random effect was used. LS means and 90% CIs for treatment differences on log-scale were obtained and back-transformed to provide geometric LS mean ratios of AFOLIA over Gonal-f® RFF.||249.81|125.65|
72562199|NCT02459418|144655746|OTHER||Median Difference (Net)|2.14|||||TWO_SIDED|90.0|-9.91|12.29||||||Non-transformed Tmax was tested using the non-parametric Wilcoxon signed rank test to assess the differences between Gonal-f® RFF and AFOLIA. Median difference and corresponding 90% CIs were was calculated using an Exact Hodges-Lehmann estimate with an exact confidence interval.||12.29|-9.91|
72562200|NCT00835796|144655758|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Geometric Test/Ref Ratio x 100|101.0||||||90.0|94.2|109.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||109|94.2|
72452472|NCT02307682|144427690|OTHER||Difference in proportions|-4.6|||||TWO_SIDED|95.0|-11.1|2.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 48||2.1|-11.1|
72452473|NCT02307682|144427690|OTHER||Difference in proportions|-3.5|||||TWO_SIDED|95.0|-10.4|3.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 48||3.5|-10.4|
72452474|NCT02307682|144427690|OTHER||Difference in proportions|-1.0|||||TWO_SIDED|95.0|-8.0|5.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 52||5.7|-8.0|
72562201|NCT00835796|144655759|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Geometric Test/Ref Ratio x 100|98.7||||||90.0|94.0|104.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||104|94.0|
72562202|NCT00835796|144655760|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Geometric Test/Ref Ratio x 100|98.8||||||90.0|94.5|103.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||103|94.5|
72452475|NCT02307682|144427690|OTHER||Difference in proportions|-2.7|||||TWO_SIDED|95.0|-9.7|4.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 52||4.8|-9.7|
72452476|NCT02307682|144427690|OTHER||Difference in proportions|1.4|||||TWO_SIDED|95.0|-5.5|7.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 56||7.9|-5.5|
72452477|NCT02307682|144427690|OTHER||Difference in proportions|-0.6|||||TWO_SIDED|95.0|-7.2|6.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 56||6.5|-7.2|
72452478|NCT02307682|144427690|OTHER||Difference in proportions|1.0|||||TWO_SIDED|95.0|-5.8|8.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 60||8.4|-5.8|
72562203|NCT02051595|144655812|SUPERIORITY_OR_OTHER||estimate (beta) from mixed model|-0.068|STANDARD_ERROR_OF_MEAN|0.015|<|0.0001|TWO_SIDED|95.0|-0.098|-0.039||A priori threshold was set to p \< 0.05.|Mixed Models Analysis|Analyses modeled change in vancomycin concentrations (independent variable defined by time). Analyses were adjusted for covariates.|Negative beta value indicates that vancomycin concentration decreased following cardiopulmonary bypass (CPB).|||-0.039|-0.098|<0.0001
72620021|NCT00553475|144771026|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.21||||0.0365||95.0|-0.4|-0.01|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.01|-0.40|0.0365
72452479|NCT02307682|144427690|OTHER||Difference in proportions|-0.3|||||TWO_SIDED|95.0|-7.2|6.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 60||6.9|-7.2|
72452480|NCT02307682|144427690|OTHER||Difference in proportions|-1.0|||||TWO_SIDED|95.0|-7.9|5.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 64||5.5|-7.9|
72391605|NCT03292588|144290441|SUPERIORITY|Negative binomial model for the rate of exacerbations (per year. The model included an offset term to account for differential follow-up among participants. To account for adaptive randomization, the model was also adjusted for study site, number of exacerbations in year prior to study (2 or 3+), peripheral blood eosinophils (\< or ≥400 cells/μl), BMI (\< or ≥95th percentile for age), total serum IgE (\< or ≥540 kUA/L) and treatment dose (40 mg or 100 mg).|Risk Ratio (RR)|0.67||||0.025|TWO_SIDED|95.0|0.47|0.95|||Regression, Negative Binomial|||Fit FDA-approved dosing||0.95|0.47|0.025
72391606|NCT03292588|144290442|SUPERIORITY||Hazard Ratio (HR)|0.86||||0.3587|TWO_SIDED|95.0|0.63|1.18|||Regression, Cox|||||1.18|0.63|0.3587
72391607|NCT00869349|144290458|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.6||||0.04|TWO_SIDED|95.0|-1.1|0.0||a priori threshold for statistical significance was \<0.05.|t-test, 2 sided|||Treatment effects are reported as mean between-group differences from baseline to 21 months using t-tests to determine the differential effect of the intervention versus the education group.||0.0|-1.1|0.04
72452481|NCT02307682|144427690|OTHER||Difference in proportions|0.5|||||TWO_SIDED|95.0|-6.6|7.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 64||7.9|-6.6|
72391608|NCT00869349|144290459|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.2||||0.01|TWO_SIDED|95.0|-5.6|-0.8||a priori threshold for statistical significance was \<0.05.|t-test, 2 sided|||Treatment effects are reported as mean between-group differences from baseline to 21 months using t-tests to determine the differential effect of the intervention versus the education group.||-0.8|-5.6|0.01
72452482|NCT02307682|144427690|OTHER||Difference in proportions|-2.1|||||TWO_SIDED|95.0|-9.4|5.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 68||5.2|-9.4|
72499287|NCT03093402|144529109|SUPERIORITY|||||||0.79||||||This p-value is from an exact likelihood ratio test at Day 29 testing that the proportion of subjects with \>= 75% improvement is equal among the 4 treatment groups.|Exact Likelihood Ratio Test|||||||0.790
72452483|NCT02307682|144427690|OTHER||Difference in proportions|-3.1|||||TWO_SIDED|95.0|-10.0|4.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 68||4.0|-10.0|
72452484|NCT02307682|144427690|OTHER||Difference in proportions|1.4|||||TWO_SIDED|95.0|-6.2|8.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 72||8.2|-6.2|
72452485|NCT02307682|144427690|OTHER||Difference in proportions|1.7|||||TWO_SIDED|95.0|-5.5|9.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 72||9.3|-5.5|
72499288|NCT03093402|144529109|SUPERIORITY|||||||0.843||||||This p-value is from an exact likelihood ratio test at Day 57 testing that the proportion of subjects with \>= 75% improvement is equal among the 4 treatment groups.|Exact Likelihood Ratio Test|||||||0.843
72452486|NCT02307682|144427690|OTHER||Difference in proportions|2.4|||||TWO_SIDED|95.0|-5.1|9.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 76||9.6|-5.1|
72452487|NCT02307682|144427690|OTHER||Difference in proportions|1.9|||||TWO_SIDED|95.0|-5.0|8.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 76||8.9|-5.0|
72452488|NCT02307682|144427690|OTHER||Difference in proportions|3.2|||||TWO_SIDED|95.0|-3.9|10.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 80||10.3|-3.9|
72452489|NCT02307682|144427690|OTHER||Difference in proportions|0.8|||||TWO_SIDED|95.0|-6.1|8.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 80||8.1|-6.1|
72452490|NCT02307682|144427690|OTHER||Difference in proportions|1.9|||||TWO_SIDED|95.0|-5.1|8.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 84||8.9|-5.1|
72452491|NCT02307682|144427690|OTHER||Difference in proportions|1.3|||||TWO_SIDED|95.0|-5.9|8.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 84||8.4|-5.9|
72452492|NCT02307682|144427690|OTHER||Difference in proportions|-1.2|||||TWO_SIDED|95.0|-8.5|5.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 88||5.8|-8.5|
72452493|NCT02307682|144427690|OTHER||Difference in proportions|-2.5|||||TWO_SIDED|95.0|-9.7|4.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 88||4.7|-9.7|
72499289|NCT03093402|144529109|SUPERIORITY|||||||0.637||||||This p-value is from an exact likelihood ratio test at Day 85 testing that the proportion of subjects with \>= 75% improvement is equal among the 4 treatment groups.|Exact Likelihood Ratio Test|||||||0.637
72499290|NCT03093402|144529109|SUPERIORITY|||||||0.243||||||This p-value is from an exact likelihood ratio test at Day 113 testing that the proportion of subjects with \>= 75% improvement is equal among the 4 treatment groups.|Exact Likelihood Ratio Test|||||||0.243
72499291|NCT03093402|144529110|SUPERIORITY||||||>|0.999||||||This p-value is from an exact likelihood ratio test at Day 57 testing that the proportion of subjects with \>=100% improvement is equal among the 4 treatment groups.|Exact Likelihood Ratio Test|||JBT-101 High, JBT-101 Medium, JBT-101 Low, Placebo||||>0.999
72499292|NCT03093402|144529110|SUPERIORITY|||||||0.861||||||This p-value is from an exact likelihood ratio test at Day 85 testing that the proportion of subjects with \>= 100% improvement is equal among the 4 treatment groups.|Exact Likelihood Ratio Test|||JBT-101 High, JBT-101 Medium, JBT-101 Low, Placebo||||0.861
72620022|NCT00553475|144771026|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.37||||0.0073||95.0|-0.65|-0.1|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.10|-0.65|0.0073
72620023|NCT00553475|144771027|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.37||||0.0019||95.0|-10.38|-2.36|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-2.36|-10.38|0.0019
72620024|NCT00553475|144771027|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.78||||0.1907||95.0|-9.45|1.89|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||1.89|-9.45|0.1907
72499293|NCT03093402|144529111|SUPERIORITY||Mean Difference (Final Values)|2.0||||0.39|TWO_SIDED|95.0|-4.8|8.7||This p-value is from the overall 3 degree of freedom test that simultaneously compares the mean difference in the change from baseline tender joint count at Day 85 for each of the 3 JBT-101 cohorts versus placebo.|Mixed Models Analysis||Mean difference in the change from baseline tender joint count for High JBT-101 - Placebo. The estimated tender joint count mean change from baseline (95% confidence interval) for Placebo was -6.3 (-12.0, -0.7).|Each active JBT-101 cohort is compared to placebo.||8.7|-4.8|0.390
72499294|NCT03093402|144529111|SUPERIORITY||Mean Difference (Final Values)|1.7||||0.39|TWO_SIDED|95.0|-4.9|8.2||This p-value is from the overall 3 degree of freedom test that simultaneously compares the mean difference in the change from baseline tender joint count at Day 85 for each of the 3 JBT-101 cohorts versus placebo.|Mixed Models Analysis||Mean difference in the change from baseline tender joint count for Medium JBT-101 - Placebo. The estimated tender joint count mean change from baseline (95% confidence interval) for Placebo was -6.3 (-12.0, -0.7).|Each active JBT-101 cohort is compared to placebo.||8.2|-4.9|0.390
72499295|NCT03093402|144529111|SUPERIORITY||Median Difference (Final Values)|-2.0||||0.39|TWO_SIDED|95.0|-8.6|4.6||This p-value is from the overall 3 degree of freedom test that simultaneously compares the mean difference in the change from baseline tender joint count at Day 85 for each of the 3 JBT-101 cohorts versus placebo.|Mixed Models Analysis||Mean difference in the change from baseline tender joint count for Low JBT-101 - Placebo. The estimated tender joint count mean change from baseline (95% confidence interval) for Placebo was -6.3 (-12.0, -0.7).|Each active JBT-101 cohort is compared to placebo.||4.6|-8.6|0.390
72620025|NCT00553475|144771028|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.03||||0.9905||95.0|-5.37|5.43|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||5.43|-5.37|0.9905
72620026|NCT00553475|144771028|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.44||||0.2532||95.0|-3.19|12.08|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||12.08|-3.19|0.2532
72391609|NCT00869349|144290460|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.8||||0.01|TWO_SIDED|95.0|0.5|3.1||a priori threshold for statistical significance was \<0.05.|t-test, 2 sided|||Treatment effects are reported as mean between-group differences from baseline to 21 months using t-tests to determine the differential effect of the intervention versus the education group.||3.1|0.5|0.01
72391610|NCT03633695|144290461|SUPERIORITY||Mean Difference (Final Values)|-0.177|||<|0.0001|TWO_SIDED|95.0|-0.214|-0.14||The threshold for statistical significance was p=0.05.|t-test, 2 sided||Acuity Difference = IC-8 Group - Control Group|The null hypothesis was that the mean acuity for the IC-8 Group was greater (i.e. worse) than or equal to that for the Control Group. The alternative hypothesis was that the mean for the IC-8 Group less (i.e., better) than that for the Control Group.||-0.140|-0.214|<.0001
72391611|NCT03633695|144290462|SUPERIORITY||Mean Difference (Final Values)|-0.191|||<|0.0001|TWO_SIDED|95.0|-0.223|-0.158||The threshold for statistical significance was p=0.05.|t-test, 2 sided||Acuity Difference = IC-8 Group - Control Group|The null hypothesis was that the mean acuity for the IC-8 Group was greater (i.e. worse) than or equal to that for the Control Group. The alternative hypothesis was that the mean for the IC-8 Group less (i.e., better) than that for the Control Group.||-0.158|-0.223|<.0001
72391612|NCT03633695|144290463|NON_INFERIORITY|Non-inferiority margin was 0.1 logMAR.|Mean Difference (Final Values)|-0.012|||<|0.0001|ONE_SIDED|95.0||0.007||The threshold for statistical significance was p=0.05.|t-test, 1 sided||Acuity Difference = IC-8 IOL Group - Control Group|The null hypothesis was that the mean acuity for the IC-8 IOL Group is inferior to the Control Group by 0.1 logMAR or more. The alternative hypothesis was that the mean acuity for the IC-8 IOL group is inferior to the Control Group by less than 0.1 logMAR.||0.007||<.0001
72391613|NCT03633695|144290464|SUPERIORITY||Mean Difference (Final Values)|-0.18|||<|0.0001|TWO_SIDED|95.0|-0.198|-0.163||The threshold for statistical significance was p=0.05.|t-test, 2 sided||Acuity Difference = IC-8 IOL Eye (IC-8 IOL Group) - Fellow Eye (IC-8 IOL Group)|The null hypothesis was that the mean acuity for the IC-8 IOL eyes is greater (i.e., worse) than or equal to that for the fellow eyes. The alternative hypothesis was that the mean for the IC-8 IOL eyes is less (i.e., better) than that for the fellow eyes.||-0.163|-0.198|<.0001
72391614|NCT03633695|144290465|OTHER||Difference in depth of focus|0.91|||||TWO_SIDED||||||||Difference in depth of focus \[IC-8™ IOL Eyes (IC-8™ IOL Group) - Fellow Eyes (IC-8™ IOL Group)\]|||||
72391615|NCT03633695|144290466|NON_INFERIORITY|The non-inferiority margin was 0.1 logMAR.|Mean Difference (Final Values)|0.068|||<|0.0001|ONE_SIDED|95.0||0.082||The threshold for statistical significance was p=0.05.|t-test, 1 sided||Acuity Difference = IC-8 IOL Eyes (IC-8 Group) - Fellow Eyes (IC-8 Group)|The null hypothesis was that the mean acuity for the IC-8 IOL eyes was inferior to the fellow eyes by 0.1 logMAR or more. The alternative hypothesis was that the mean acuity for the IC-8 eyes was inferior to the fellow eyes by less than 0.1 logMAR.||0.082||<.0001
72391616|NCT03633695|144290474|NON_INFERIORITY|Non-inferiority margin was 0.12 logMAR.|Mean Difference (Final Values)|0.023|||<|0.0001|TWO_SIDED|95.0||||The threshold for statistical significance was p=0.05.|t-test, 1 sided|||The null hypothesis was that the mean acuity in Astigmatism Group 2 was inferior to the Astigmatism Group 1 by 0.12 logMAR or more. The alternative hypothesis was that the mean acuity in Astigmatism Group 2 was inferior to Astigmatism Group 1 by less than 0.12 logMAR.||||<.0001
72391617|NCT02728050|144290485|SUPERIORITY|||||||0.48|||||||Fisher Exact|||"Participants on study receiving CLAGM-S were compared to a historical cohort of newly diagnosed AML/high-risk MDS patients treated with CLAG-M alone, matched for mitoxantrone dose, age, and TRM score.~Number of participants in historical cohort = 71. Number of participants in historical cohort who achieved MRD-negative CR = 55 (77.46%)"||||0.48
72391618|NCT01976338|144290502|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
72391619|NCT00777608|144290512|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.07||||0.231|TWO_SIDED|90.0|-0.2|0.08|||ANOVA|||||0.08|-0.2|0.231
72391620|NCT00777608|144290513|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.09||0.041|TWO_SIDED|90.0|-0.3|-0.008|||ANOVA||Statistical analysis for Week 2|||-0.008|-0.3|0.041
72391621|NCT00777608|144290513|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.09||0.143|TWO_SIDED|90.0|-0.3|0.06|||ANOVA||Statistical analysis for Week 8|||0.06|-0.3|0.143
72452494|NCT02307682|144427690|OTHER||Difference in proportions|-0.4|||||TWO_SIDED|95.0|-7.9|6.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 92||6.5|-7.9|
72452495|NCT02307682|144427690|OTHER||Difference in proportions|-2.1|||||TWO_SIDED|95.0|-9.1|5.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 92||5.5|-9.1|
72499296|NCT03093402|144529112|SUPERIORITY||Median Difference (Final Values)|0.7||||0.556|TWO_SIDED|95.0|-1.6|3.0||This p-value is from the overall 3 degree of freedom test that simultaneously compares the mean difference in the change from baseline swollen joint count at Day 85 for each of the 3 JBT-101 cohorts versus placebo.|Mixed Models Analysis||Mean difference in the change from baseline swollen joint count for High JBT-101 - Placebo. The estimated swollen joint count mean change from baseline (95% confidence interval) for Placebo was -4.0 (-5.7, -2.4).|Each active JBT-101 cohort is compared to placebo.||3.0|-1.6|0.556
72499297|NCT03093402|144529112|SUPERIORITY||Mean Difference (Final Values)|-0.3||||0.556|TWO_SIDED|95.0|-2.5|2.0||This p-value is from the overall 3 degree of freedom test that simultaneously compares the mean difference in the change from baseline swollen joint count at Day 85 for each JBT-101 cohort versus placebo.|Mixed Models Analysis||Mean difference in the change from baseline swollen joint count for Medium JBT-101 - Placebo. The estimated swollen joint count mean change from baseline (95% confidence interval) for Placebo was -4.0 (-5.7, -2.4).|Each active JBT-101 cohort is compared to placebo.||2.0|-2.5|0.556
72499298|NCT03093402|144529112|SUPERIORITY||Mean Difference (Final Values)|-0.8||||0.556|TWO_SIDED|95.0|-3.1|1.4||This p-value is from the overall 3 degree of freedom test that simultaneously compares the mean difference in the change from baseline swollen joint count at Day 85 for each of the 3 JBT-101 cohorts versus placebo.|Mixed Models Analysis||Mean difference in the change from baseline swollen joint count for High JBT-101 - Placebo. The estimated swollen joint count mean change from baseline (95% confidence interval) for Placebo was -4.0 (-5.7, -2.4).|Each active JBT-101 cohort is compared to placebo.||1.4|-3.1|0.556
72499299|NCT03093402|144529113|SUPERIORITY|||||||0.669|||||||Mixed Models Analysis|||The dichotomous outcome is modeled using the generalized estimating equations approach under the binomial distribution with a logit link. The model includes fixed effects for visit, treatment and visit\*treatment interaction with an unstructured within-subject correlation structure across visits. The overall test p-value is a 3 degree-of-freedom test comparing each of the 3 active treatments vs. placebo at Day 29.||||0.669
72499300|NCT03093402|144529113|SUPERIORITY|||||||0.432|||||||Mixed Models Analysis|||The dichotomous outcome is modeled using the generalized estimating equations approach under the binomial distribution with a logit link. The model includes fixed effects for visit, treatment and visit\*treatment interaction with an unstructured within-subject correlation structure across visits. The overall test p-value is a 3 degree-of-freedom test comparing each of the 3 active treatments vs. placebo at Day 57.||||0.432
72499301|NCT03093402|144529113|SUPERIORITY|||||||0.78|||||||Mixed Models Analysis|||The dichotomous outcome is modeled using the generalized estimating equations approach under the binomial distribution with a logit link. The model includes fixed effects for visit, treatment and visit\*treatment interaction with an unstructured within-subject correlation structure across visits. The overall test p-value is a 3 degree-of-freedom test comparing each of the 3 active treatments vs. placebo at Day 85.||||0.780
72499302|NCT03093402|144529113|SUPERIORITY|||||||0.285|||||||Mixed Models Analysis|||The dichotomous outcome is modeled using the generalized estimating equations approach under the binomial distribution with a logit link. The model includes fixed effects for visit, treatment and visit\*treatment interaction with an unstructured within-subject correlation structure across visits. The overall test p-value is a 3 degree-of-freedom test comparing each of the 3 active treatments vs. placebo at Day 113.||||0.285
72499303|NCT03093402|144529115|SUPERIORITY|The dichotomous outcome is modeled using the generalized estimating equations approach under the binomial distribution with a logit link. The model includes fixed effects for visit, treatment and visit\*treatment interaction with an unstructured within-subject correlation structure across visits. The overall test p-value is a 3 degree-of-freedom test comparing each of the 3 active treatments vs. placebo at Day 29.||||||0.872|||||||Mixed Models Analysis|||JBT-101 High, JBT-101 Medium, JBT-101 Low, Placebo||||0.872
72562204|NCT00407745|144655820|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.59|STANDARD_ERROR_OF_MEAN|0.198||0.0032|TWO_SIDED|95.0|-0.98|-0.2||Significance was declared if the 2-tailed test for the difference between treatment groups was significant at the 0.05 level.|ANCOVA|||"Null hypothesis - the mean DAAC for the pregabalin group is equal to the mean DAAC for the placebo group; Alternative hypothesis - the mean DAAC for the placebo group differs from the mean DAAC for the pregabalin group.~ANCOVA model included baseline severity of pain and Baseline Pain Catastrophizing Scale (PCS) Total Score as covariates and pooled center and treatment as fixed (class) cofactors."||-0.20|-0.98|0.0032
72562205|NCT00407745|144655821|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.255||0.0066|TWO_SIDED|95.0|-1.2|-0.2||Serial gate-keeping multiple testing procedure was used. If primary comparison for DAAC was significant, then variables were assessed in a hierarchical manner. Significance was declared if unadjusted p-value was significant at 0.05 level (\<=0.05).|ANCOVA|ANCOVA model included baseline severity (pain) and baseline PCS as covariates and effects for treatment and pooled center as fixed (class) cofactors.||Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group.||-0.20|-1.20|0.0066
72452496|NCT02307682|144427690|OTHER||Difference in proportions|4.6|||||TWO_SIDED|95.0|-2.9|11.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 96||11.2|-2.9|
72620027|NCT00553475|144771029|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.39||||0.4538||95.0|-5.05|2.26|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||2.26|-5.05|0.4538
72620028|NCT00553475|144771029|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.84||||0.2782||95.0|-7.97|2.3|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||2.30|-7.97|0.2782
72620029|NCT00553475|144771030|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.32||||0.0177||95.0|0.06|0.59|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||0.59|0.06|0.0177
72620030|NCT00553475|144771030|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.17||||0.3661||95.0|-0.2|0.55|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||0.55|-0.20|0.3661
72620031|NCT00553475|144771031|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.62||||0.0511||95.0|-0.03|11.26|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||11.26|-0.03|0.0511
72391622|NCT00777608|144290513|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.07|STANDARD_ERROR_OF_MEAN|0.1||0.226|TWO_SIDED|90.0|-0.2|0.09|||ANOVA||Statistical analysis for Week 12|||0.09|-0.2|0.226
72499304|NCT03093402|144529115|SUPERIORITY|The dichotomous outcome is modeled using the generalized estimating equations approach under the binomial distribution with a logit link. The model includes fixed effects for visit, treatment and visit\*treatment interaction with an unstructured within-subject correlation structure across visits. The overall test p-value is a 3 degree-of-freedom test comparing each of the 3 active treatments vs. placebo at Day 57.||||||0.895|||||||Mixed Models Analysis|||JBT-101 High, JBT-101 Medium, JBT-101 Low, Placebo||||0.895
72499305|NCT03093402|144529115|SUPERIORITY|The dichotomous outcome is modeled using the generalized estimating equations approach under the binomial distribution with a logit link. The model includes fixed effects for visit, treatment and visit\*treatment interaction with an unstructured within-subject correlation structure across visits. The overall test p-value is a 3 degree-of-freedom test comparing each of the 3 active treatments vs. placebo at Day 85.||||||0.669|||||||Mixed Models Analysis|||JBT-101 High, JBT-101 Medium, JBT-101 Low, Placebo||||0.669
72499306|NCT03093402|144529115|SUPERIORITY|The dichotomous outcome is modeled using the generalized estimating equations approach under the binomial distribution with a logit link. The model includes fixed effects for visit, treatment and visit\*treatment interaction with an unstructured within-subject correlation structure across visits. The overall test p-value is a 3 degree-of-freedom test comparing each of the 3 active treatments vs. placebo at Day 113.||||||0.668|||||||Mixed Models Analysis|||JBT-101 High, JBT-101 Medium, JBT-101 Low, Placebo||||0.668
72499307|NCT03093402|144529116|SUPERIORITY||Mean Difference (Final Values)|-0.4||||0.82|TWO_SIDED|95.0|-2.3|1.5||This p-value is from the overall 3 degree of freedom test that simultaneously compares the mean difference in the change from baseline SELENA-SLEDAI Score at Day 85 for each of the 3 JBT-101 cohorts versus placebo.|Mixed Models Analysis||Mean difference in the change from baseline SLEDAI score for High JBT-101 - Placebo. The estimated Day 85 SLEDAI mean change from baseline (95% confidence interval) for Placebo was -2.2 (-3.6, -0.8).|Each active JBT-101 cohort is compared to placebo.||1.5|-2.3|.820
72499308|NCT03093402|144529116|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.82|TWO_SIDED|95.0|-2.0|1.8||This p-value is from the overall 3 degree of freedom test that simultaneously compares the mean difference in the change from baseline SELENA-SLEDAI Score at Day 85 for each of the 3 JBT-101 cohorts versus placebo.|Mixed Models Analysis||Mean difference in the change from baseline SLEDAI score for Medium JBT-101 - Placebo. The estimated Day 85 SLEDAI mean change from baseline (95% confidence interval) for Placebo was -2.2 (-3.6, -0.8).|Each active JBT-101 cohort is compared to placebo.||1.8|-2.0|.820
72620032|NCT00553475|144771031|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|9.65||||0.0173||95.0|1.72|17.59|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||17.59|1.72|0.0173
72620033|NCT00553475|144771032|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.79||||0.1123||95.0|-0.89|8.47|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||8.47|-0.89|0.1123
72620034|NCT00553475|144771032|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|7.79||||0.0206||95.0|1.2|14.38|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||14.38|1.20|0.0206
72620035|NCT00553475|144771033|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.54||||0.0269||95.0|-6.67|-0.41|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.41|-6.67|0.0269
72620036|NCT00553475|144771033|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.82||||0.4183||95.0|-6.24|2.6|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||2.60|-6.24|0.4183
72620037|NCT00553475|144771034|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0148||95.0|||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel chi-squared with a modified ridit transformation, stratified by stratum based on the CLcr||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||||0.0148
72620038|NCT00553475|144771034|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0063||95.0|||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel chi-squared with a modified ridit transformation, stratified by stratum based on the CLcr||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||||0.0063
72499309|NCT03093402|144529116|SUPERIORITY||Mean Difference (Final Values)|-0.8||||0.82|TWO_SIDED|95.0|-2.6|1.1||This p-value is from the overall 3 degree of freedom test that simultaneously compares the mean difference in the change from baseline SELENA-SLEDAI Score at Day 85 for each of the 3 JBT-101 cohorts versus placebo.|Mixed Models Analysis||Mean difference in the change from baseline SLEDAI score for Low JBT-101 - Placebo. The estimated Day 85 SLEDAI mean change from baseline (95% confidence interval) for Placebo was -2.2 (-3.6, -0.8).|Each active JBT-101 cohort is compared to placebo.||1.1|-2.6|.820
72620039|NCT00553475|144771035|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0818||95.0|||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel chi-squared with a modified ridit transformation, stratified by stratum based on the CLcr||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||||0.0818
72391623|NCT00777608|144290514|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.5|STANDARD_ERROR_OF_MEAN|1.0||0.324|TWO_SIDED|90.0|-1.2|2.2|||ANOVA||Statistical analysis for Week 4|||2.2|-1.2|0.324
72391624|NCT00777608|144290514|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.8|STANDARD_ERROR_OF_MEAN|1.4||0.285|TWO_SIDED|90.0|-1.5|3.1|||ANOVA|||||3.1|-1.5|0.285
72391625|NCT00777608|144290514|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|1.3||0.401|TWO_SIDED|90.0|-2.6|1.9|||ANOVA||Statistical analysis for Week 12|||1.9|-2.6|0.401
72391626|NCT03766581|144290525|SUPERIORITY||Relative Risk (RR)|0.99|||||TWO_SIDED|95.0|0.87|1.1|||MCP-MOD|Multiple Comparison Procedures, MODel|95% confidence interval (CI) for composite event based on bootstrap (10000 samples)|Milvexian 25 mg QD over Placebo||1.10|0.87|
72391627|NCT03766581|144290525|SUPERIORITY||Relative Risk (RR)|0.99|||||TWO_SIDED|95.0|0.83|1.15|||MCP-MOD|Multiple Comparison Procedures, MODel|95% confidence interval (CI) for composite event based on bootstrap (10000 samples)|Milvexian 25 mg BID over Placebo||1.15|0.83|
72391628|NCT03766581|144290525|SUPERIORITY||Relative Risk (RR)|0.93|||||TWO_SIDED|95.0|0.76|1.16|||MCP-MOD|Multiple Comparison Procedures, MODel|95% confidence interval (CI) for composite event based on bootstrap (10000 samples)|Milvexian 50 mg BID over Placebo||1.16|0.76|
72391629|NCT03766581|144290525|SUPERIORITY||Relative Risk (RR)|0.92|||||TWO_SIDED|95.0|0.73|1.18|||MCP-MOD|Multiple Comparison Procedures, MODel|95% confidence interval (CI) for composite event based on bootstrap (10000 samples)|Milvexian 100 mg BID over Placebo||1.18|0.73|
72391630|NCT03766581|144290525|SUPERIORITY||Relative Risk (RR)|0.91|||||TWO_SIDED|95.0|0.69|1.31|||MCP-MOD|Multiple Comparison Procedures, MODel|95% confidence interval (CI) for composite event based on bootstrap (10000 samples)|Milvexian 200 mg BID over Placebo||1.31|0.69|
72391631|NCT03766581|144290547|SUPERIORITY||Relative Risk (RR)|0.83|||||TWO_SIDED|95.0|0.46|1.49|||Wald Confidence Limits|95% CIs for RR are constructed using Wald Confidence Limits||Milvexian 25 mg QD over Placebo||1.49|0.46|
72391632|NCT03766581|144290547|SUPERIORITY||Relative Risk (RR)|0.69|||||TWO_SIDED|95.0|0.36|1.3|||Wald Confidence Limits|95% CIs for RR are constructed using Wald Confidence Limits||Milvexian 25 mg BID over Placebo||1.30|0.36|
72391633|NCT03766581|144290547|SUPERIORITY||Relative Risk (RR)|0.72|||||TWO_SIDED|95.0|0.39|1.33|||Wald Confidence Limits|95% CIs for RR are constructed using Wald Confidence Limits||Milvexian 50 mg BID over Placebo||1.33|0.39|
72391634|NCT03766581|144290547|SUPERIORITY||Relative Risk (RR)|0.65|||||TWO_SIDED|95.0|0.33|1.25|||Wald Confidence Limits|95% CIs for RR are constructed using Wald Confidence Limits||Milvexian 100 mg BID over Placebo||1.25|0.33|
72391635|NCT03766581|144290547|SUPERIORITY||Relative Risk (RR)|1.4|||||TWO_SIDED|95.0|0.87|2.25|||Wald Confidence Limits|95% CIs for RR are constructed using Wald Confidence Limits||Milvexian 200 mg BID||2.25|0.87|
72391636|NCT03766581|144290547|SUPERIORITY||Relative Risk (RR)|2.48|||||TWO_SIDED|95.0|0.83|7.42|||Wald Confidence Limits|95% CIs for RR are constructed using Wald Confidence Limits||Milvexian 50 mg QD over Placebo||7.42|0.83|
72391637|NCT03766581|144290547|SUPERIORITY||Relative Risk (RR)|1.01|||||TWO_SIDED|95.0|0.15|6.96|||Wald Confidence Limits|95% CIs for RR are constructed using Wald Confidence Limits||Milvexian 100 mg QD over Placebo||6.96|0.15|
72391638|NCT01697566|144290630|SUPERIORITY|||||||0.006|||||||t-test, 2 sided|||Body Weight||||0.006
72391639|NCT01697566|144290630|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||Fat Mass||||<0.001
72391640|NCT01697566|144290632|SUPERIORITY|||||||0.019|||||||t-test, 2 sided|||||||0.019
72391641|NCT01930123|144290634|OTHER||Mean Difference (Final Values)|6.26|STANDARD_DEVIATION|9.98||0.01|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.01
72391642|NCT01930123|144290635|OTHER|||||||0.006|||||||Wilcoxon (Mann-Whitney)|||Mild fibrosis vs. advanced fibrosis||||0.006
72391643|NCT01930123|144290636|OTHER||Median Difference (Final Values)|56.7|STANDARD_DEVIATION|2.6||0.09|TWO_SIDED||||||t-test, 1 sided|||||||0.09
72391644|NCT01447433|144290643|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.439|STANDARD_ERROR_OF_MEAN|0.56||0.441|TWO_SIDED|95.0|-0.7|1.58|||t-test, 2 sided|||||1.58|-0.70|0.441
72391645|NCT01447433|144290644|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.88|STANDARD_ERROR_OF_MEAN|0.41||0.038|TWO_SIDED|95.0|0.05|1.7|||t-test, 2 sided|||Body Fat Mass||1.70|0.05|0.038
72391646|NCT01447433|144290644|SUPERIORITY_OR_OTHER||Median Difference (Net)|-0.5|STANDARD_ERROR_OF_MEAN|0.28||0.082|TWO_SIDED|95.0|-1.06|0.07|||t-test, 2 sided|||Body Lean Mass||0.07|-1.06|0.082
72391647|NCT01447433|144290644|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.18|STANDARD_ERROR_OF_MEAN|0.07||0.018|TWO_SIDED|95.0|0.03|0.32|||t-test, 2 sided|||Visceral Fat Mass||0.32|0.03|0.018
72499310|NCT03093402|144529117|SUPERIORITY||Mean Difference (Final Values)|0.7||||0.244|TWO_SIDED|95.0|-3.0|4.4||This p-value is from the overall 3 degree of freedom test that simultaneously compares the mean difference in the change from baseline BILAG total score at Day 85 for each of the 3 JBT-101 cohorts versus placebo.|Mixed Models Analysis||Mean difference in the change from baseline BILAG score for High JBT-101 - Placebo. The estimated Day 85 change from baseline and 95% confidence interval for the Placebo group was -4.3 (-7.0, -1.5).|Each active JBT-101 cohort is compared to placebo.||4.4|-3.0|.244
72620040|NCT00553475|144771035|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0075||95.0|||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel chi-squared with a modified ridit transformation, stratified by stratum based on the CLcr||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||||0.0075
72391648|NCT01447433|144290645|SUPERIORITY_OR_OTHER||Median Difference (Net)|1.1|STANDARD_ERROR_OF_MEAN|0.49||0.031|TWO_SIDED|95.0|0.1|2.09|||t-test, 2 sided|||||2.09|0.10|0.031
72391649|NCT01447433|144290646|SUPERIORITY_OR_OTHER||Median Difference (Net)|5.72|STANDARD_ERROR_OF_MEAN|2.25||0.016|TWO_SIDED|95.0|1.15|10.29|||t-test, 2 sided|||||10.29|1.15|0.016
72452497|NCT02307682|144427690|OTHER||Difference in proportions|0.6|||||TWO_SIDED|95.0|-6.6|8.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 96||8.0|-6.6|
72452498|NCT02307682|144427691|OTHER||Difference in proportions|0.4|||||TWO_SIDED|95.0|-1.4|2.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 4||2.2|-1.4|
72452499|NCT02307682|144427691|OTHER||Difference in proportions|1.7|||||TWO_SIDED|95.0|-0.5|4.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 4||4.0|-0.5|
72452500|NCT02307682|144427691|OTHER||Difference in proportions|-0.6|||||TWO_SIDED|95.0|-2.6|1.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 8||1.5|-2.6|
72452501|NCT02307682|144427691|OTHER||Difference in proportions|0.7|||||TWO_SIDED|95.0|-1.7|2.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 8||2.9|-1.7|
72452502|NCT02307682|144427691|OTHER||Difference in proportions|-0.6|||||TWO_SIDED|95.0|-3.3|2.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 12||2.2|-3.3|
72452503|NCT02307682|144427691|OTHER||Difference in proportions|-0.3|||||TWO_SIDED|95.0|-3.2|2.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 12||2.7|-3.2|
72452504|NCT02307682|144427691|OTHER||Difference in proportions|-0.3|||||TWO_SIDED|95.0|-3.0|2.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 16||2.4|-3.0|
72452505|NCT02307682|144427691|OTHER||Difference in proportions|0.3|||||TWO_SIDED|95.0|-2.4|3.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 16||3.1|-2.4|
72562206|NCT00407745|144655822|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.85||||0.039|TWO_SIDED|95.0|1.032|3.328||Serial gate-keeping multiple testing was used. If primary comparison for DAAC was significant, then variables were assessed in hierarchical manner. Significance was declared if unadjusted p-value at 0.05 level and preceding tests were significant.|Regression, Logistic|Logistic regression model used terms for baseline pain score and baseline PCS total score as covariate, and pooled center and treatment as cofactor.||Null hypothesis - The rate of responder for the pregabain group was equal to the rate of responder for the placebo group; Alternative hypothesis - The rate of responder for the pregabain group was not equal to the rate of responder for the placebo group||3.328|1.032|0.0390
72391650|NCT01447433|144290647|SUPERIORITY_OR_OTHER||Median Difference (Net)|1.14|STANDARD_ERROR_OF_MEAN|1.7||0.508|TWO_SIDED|95.0|-2.31|4.58|||t-test, 2 sided|||Waist Circumference||4.58|-2.31|0.508
72452506|NCT02307682|144427691|OTHER||Difference in proportions|0.0|||||TWO_SIDED|95.0|-2.2|2.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 20||2.4|-2.2|
72452507|NCT02307682|144427691|OTHER||Difference in proportions|2.3|||||TWO_SIDED|95.0|-0.3|5.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 20||5.3|-0.3|
72452508|NCT02307682|144427691|OTHER||Difference in proportions|0.3|||||TWO_SIDED|95.0|-2.6|3.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 24||3.2|-2.6|
72452509|NCT02307682|144427691|OTHER||Difference in proportions|1.5|||||TWO_SIDED|95.0|-1.8|4.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 24||4.6|-1.8|
72452510|NCT02307682|144427691|OTHER||Difference in proportions|0.2|||||TWO_SIDED|95.0|-2.9|3.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 28||3.3|-2.9|
72391651|NCT01447433|144290647|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.22|STANDARD_ERROR_OF_MEAN|2.07||0.56|TWO_SIDED|95.0|-5.42|2.98|||t-test, 2 sided|||Abdominal Circumference||2.98|-5.42|0.560
72452511|NCT02307682|144427691|OTHER||Difference in proportions|1.1|||||TWO_SIDED|95.0|-2.3|4.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 28||4.6|-2.3|
72562207|NCT00407745|144655823|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0006||95.0||||Serial gate-keeping multiple testing was used. If primary comparison for DAAC was significant, then variables were assessed in hierarchical manner. Significance was declared if unadjusted p-value at 0.05 level and preceding tests were significant.|Cochran-Mantel-Haenszel|Modified ridit transformation with the Cochran-Mantel- Haenszel test was used with adjusting for pooled center.||Null hypothesis - The raw mean score for the pregabain group was equal to the raw mean score for the placebo group; Alternative hypothesis - The raw mean score for the pregabain group was not equal to the raw mean score for the placebo group.||||0.0006
72562208|NCT00407745|144655824|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.08|STANDARD_ERROR_OF_MEAN|0.265|<|0.0001|TWO_SIDED|95.0|-1.6|-0.56||Serial gate-keeping multiple testing was used. If primary comparison for DAAC was significant, then variables were assessed in hierarchical manner. Significance was declared if unadjusted p-value at 0.05 level and preceding tests were significant.|ANCOVA|ANCOVA model included baseline sleep interference score as a covariate and pooled center and treatment as fixed (class) cofactors.||Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group.||-0.56|-1.60|<0.0001
72620041|NCT00553475|144771036|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.66||||0.0013||95.0|-1.07|-0.26|||Mixed Model Repeated Measures Analysis|Model included treatment, CLcr stratum, week and treatment-by-week interaction, and baseline scores as fixed effects, and subject as a random effect.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.26|-1.07|0.0013
72620042|NCT00553475|144771036|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.74||||0.0152||95.0|-1.34|-0.14|||Mixed Model Repeated Measures Analysis|Model included treatment, CLcr stratum, week and treatment-by-week interaction, and baseline scores as fixed effects, and subject as a random effect.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.14|-1.34|0.0152
72452512|NCT02307682|144427691|OTHER||Difference in proportions|1.0|||||TWO_SIDED|95.0|-2.0|4.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 32||4.1|-2.0|
72452513|NCT02307682|144427691|OTHER||Difference in proportions|2.2|||||TWO_SIDED|95.0|-1.0|5.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 32||5.7|-1.0|
72452514|NCT02307682|144427691|OTHER||Difference in proportions|1.4|||||TWO_SIDED|95.0|-1.5|4.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 36||4.4|-1.5|
72452515|NCT02307682|144427691|OTHER||Difference in proportions|3.1|||||TWO_SIDED|95.0|0.0|6.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 36||6.5|0.0|
72452516|NCT02307682|144427691|OTHER||Difference in proportions|0.9|||||TWO_SIDED|95.0|-2.1|3.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 40||3.9|-2.1|
72452517|NCT02307682|144427691|OTHER||Difference in proportions|2.8|||||TWO_SIDED|95.0|-0.7|6.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 40||6.3|-0.7|
72452518|NCT02307682|144427691|OTHER||Difference in proportions|1.1|||||TWO_SIDED|95.0|-2.2|4.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 44||4.2|-2.2|
72622445|NCT02181413|144774859|SUPERIORITY||Hazard Ratio (HR)|0.704||||0.01|TWO_SIDED|95.0|0.539|0.92||P-value was based on log-rank test stratified by pre-induction regimen, ISS stage and response after transplantation.|Log Rank||Hazard ratio is based on an unadjusted Cox's proportional hazard regression model stratified by induction regimen, pre-induction ISS, and response after transplantation, comparing the hazard rate of Ixazomib arm over the hazard rate of Placebo arm.|MRD+ at Study Entry||0.920|0.539|0.010
72452519|NCT02307682|144427691|OTHER||Difference in proportions|2.0|||||TWO_SIDED|95.0|-1.4|5.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 44||5.2|-1.4|
72452520|NCT02307682|144427691|OTHER||Difference in proportions|0.3|||||TWO_SIDED|95.0|-3.2|3.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 48||3.9|-3.2|
72452521|NCT02307682|144427691|OTHER||Difference in proportions|0.9|||||TWO_SIDED|95.0|-2.7|4.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 48||4.3|-2.7|
72452522|NCT02307682|144427691|OTHER||Difference in proportions|0.3|||||TWO_SIDED|95.0|-3.3|4.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 52||4.0|-3.3|
72452523|NCT02307682|144427691|OTHER||Difference in proportions|1.3|||||TWO_SIDED|95.0|-2.5|4.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 52||4.8|-2.5|
72452524|NCT02307682|144427691|OTHER||Difference in proportions|1.1|||||TWO_SIDED|95.0|-2.4|4.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 56||4.6|-2.4|
72452525|NCT02307682|144427691|OTHER||Difference in proportions|2.6|||||TWO_SIDED|95.0|-1.5|6.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 56||6.3|-1.5|
72452526|NCT02307682|144427691|OTHER||Difference in proportions|0.1|||||TWO_SIDED|95.0|-3.5|3.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 60||3.6|-3.5|
72499311|NCT03093402|144529117|SUPERIORITY||Mean Difference (Final Values)|-1.6||||0.244|TWO_SIDED|95.0|-5.2|2.0||This p-value is from the overall 3 degree of freedom test that simultaneously compares the mean difference in the change from baseline BILAG total score at Day 85 for each of the 3 JBT-101 cohorts versus placebo.|Mixed Models Analysis||Mean difference in the change from baseline BILAG score for Medium JBT-101 - Placebo. The estimated Day 85 change from baseline and 95% confidence interval for the Placebo group was -4.3 (-7.0, -1.5).|Each active JBT-101 cohort is compared to placebo.||2.0|-5.2|.244
72499312|NCT03093402|144529117|SUPERIORITY||Median Difference (Final Values)|-2.6||||0.244|TWO_SIDED|95.0|-6.2|0.9||This p-value is from the overall 3 degree of freedom test that simultaneously compares the mean difference in the change from baseline BILAG total score at Day 85 for each of the 3 JBT-101 cohorts versus placebo.|Mixed Models Analysis||Mean difference in the change from baseline BILAG score for Low JBT-101 - Placebo. The estimated Day 85 change from baseline and 95% confidence interval for the Placebo group was -4.3 (-7.0, -1.5).|Each active JBT-101 cohort is compared to placebo.||0.9|-6.2|.244
72499313|NCT03093402|144529118|SUPERIORITY||Mean Difference (Final Values)|0.07||||0.408|TWO_SIDED|95.0|-0.27|0.4||This p-value is from the overall 3 degree of freedom test that simultaneously compares the mean difference in the change from baseline Physician's Global Assessment (PGA) Score at Day 85 for each of the 3 JBT-101 cohorts versus placebo.|Mixed Models Analysis||Mean difference in the change from baseline PGA score for High JBT-101 - Placebo. The estimated Day 85 change from baseline and 95% confidence interval for the Placebo group was -0.43 (-0.70, -0.15).|Each active JBT-101 cohort is compared to placebo.||0.40|-0.27|0.408
72499314|NCT03093402|144529118|SUPERIORITY||Mean Difference (Final Values)|-0.07||||0.408|TWO_SIDED|95.0|-0.4|0.26||This p-value is from the overall 3 degree of freedom test that simultaneously compares the mean difference in the change from baseline Physician's Global Assessment (PGA) Score at Day 85 for each of the 3 JBT-101 cohorts versus placebo.|Mixed Models Analysis||Mean difference in the change from baseline PGA score for High JBT-101 - Placebo. The estimated Day 85 change from baseline and 95% confidence interval for the Placebo group was -0.43 (-0.70, -0.15).|Each active JBT-101 cohort is compared to placebo.||0.26|-0.40|0.408
72499315|NCT03093402|144529118|SUPERIORITY||Mean Difference (Final Values)|-0.17||||0.408|TWO_SIDED|95.0|-0.5|0.16||This p-value is from the overall 3 degree of freedom test that simultaneously compares the mean difference in the change from baseline Physician's Global Assessment (PGA) Score at Day 85 for each of the 3 JBT-101 cohorts versus placebo.|Mixed Models Analysis||Mean difference in the change from baseline PGA score for Low JBT-101 - Placebo. The estimated Day 85 change from baseline and 95% confidence interval for the Placebo group was -0.43 (-0.70, -0.15).|Each active JBT-101 cohort is compared to placebo.||0.16|-0.50|0.408
72499316|NCT03093402|144529119|SUPERIORITY||Mean Difference (Final Values)|-21.48||||0.07|TWO_SIDED|95.0|-37.24|-5.72||This p-value is from the overall 3 degree of freedom test that simultaneously compares the mean difference in the change from baseline Patient Global Assessment Score at Day 85 for each of the 3 JBT-101 cohorts versus placebo.|Mixed Models Analysis||Mean difference in the change from baseline Patient Global Assessment score for High JBT-101 - Placebo. The estimated Day 85 change from baseline and 95% confidence interval for the Placebo group was -5.27 (-16.11, 5.56).|Each active JBT-101 cohort is compared to placebo.||-5.72|-37.24|0.070
72499317|NCT03093402|144529119|SUPERIORITY||Mean Difference (Final Values)|-10.4||||0.07|TWO_SIDED|95.0|-25.33|4.54||This p-value is from the overall 3 degree of freedom test that simultaneously compares the mean difference in the change from baseline Patient Global Assessment Score at Day 85 for each of the 3 JBT-101 cohorts versus placebo.|Mixed Models Analysis||Mean difference in the change from baseline Patient Global Assessment score for High JBT-101 - Placebo. The estimated Day 85 change from baseline and 95% confidence interval for the Placebo group was -5.27 (-16.11, 5.56).|Each active JBT-101 cohort is compared to placebo.||4.54|-25.33|0.070
72452527|NCT02307682|144427691|OTHER||Difference in proportions|1.2|||||TWO_SIDED|95.0|-2.9|4.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 60||4.9|-2.9|
72452528|NCT02307682|144427691|OTHER||Difference in proportions|1.5|||||TWO_SIDED|95.0|-2.4|5.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 64||5.1|-2.4|
72452529|NCT02307682|144427691|OTHER||Difference in proportions|2.8|||||TWO_SIDED|95.0|-1.3|6.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 64||6.7|-1.3|
72452530|NCT02307682|144427691|OTHER||Difference in proportions|0.8|||||TWO_SIDED|95.0|-3.1|4.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 68||4.5|-3.1|
72452531|NCT02307682|144427691|OTHER||Difference in proportions|1.1|||||TWO_SIDED|95.0|-2.9|4.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 68||4.9|-2.9|
72452532|NCT02307682|144427691|OTHER||Difference in proportions|1.2|||||TWO_SIDED|95.0|-2.6|4.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 72||4.7|-2.6|
72452533|NCT02307682|144427691|OTHER||Difference in proportions|1.5|||||TWO_SIDED|95.0|-2.7|5.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 72||5.3|-2.7|
72452534|NCT02307682|144427691|OTHER||Difference in proportions|0.6|||||TWO_SIDED|95.0|-3.1|4.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 76||4.2|-3.1|
72499318|NCT03093402|144529119|SUPERIORITY||Mean Difference (Final Values)|-10.81||||0.07|TWO_SIDED|95.0|-25.78|4.16||This p-value is from the overall 3 degree of freedom test that simultaneously compares the mean difference in the change from baseline Patient Global Assessment Score at Day 85 for each of the 3 JBT-101 cohorts versus placebo.|Mixed Models Analysis||Mean difference in the change from baseline Patient Global Assessment score for Low JBT-101 - Placebo. The estimated Day 85 change from baseline and 95% confidence interval for the Placebo group was -5.27 (-16.11, 5.56).|Each active JBT-101 cohort is compared to placebo.||4.16|-25.78|0.070
72499319|NCT03093402|144529120|SUPERIORITY||Median Difference (Final Values)|0.3||||0.979|TWO_SIDED|95.0|-3.38|3.99||This p-value is from the overall 3 degree of freedom test that simultaneously compares the mean difference in the change from baseline Physical Function T-score at Day 85 for each of the 3 JBT-101 cohorts versus placebo.|Mixed Models Analysis||Estimated mean difference of High JBT-101 - Placebo in the mean change from baseline at Day 85. The estimated Day 85 change from baseline and 95% confidence interval for the Placebo group was 1.8 (-0.8, 4.3).|||3.99|-3.38|0.979
72499320|NCT03093402|144529120|SUPERIORITY||Mean Difference (Final Values)|0.4||||0.979|TWO_SIDED|95.0|-3.13|3.93||This p-value is from the overall 3 degree of freedom test that simultaneously compares the mean difference in the change from baseline Physical Function T-score at Day 85 for each of the 3 JBT-101 cohorts versus placebo.|Mixed Models Analysis||Estimated mean difference of Medium JBT-101 - Placebo in the mean change from baseline at Day 85. The estimated Day 85 change from baseline and 95% confidence interval for the Placebo group was 1.8 (-0.8, 4.3).|||3.93|-3.13|0.979
72499321|NCT03093402|144529120|SUPERIORITY||Median Difference (Final Values)|0.77||||0.979|TWO_SIDED|95.0|-2.77|4.31||This p-value is from the overall 3 degree of freedom test that simultaneously compares the mean difference in the change from baseline PROMIS Physical Function Score at Day 85 for each of the 3 JBT-101 cohorts versus placebo.|Mixed Models Analysis||Estimated mean difference of Low JBT-101 - Placebo in the mean change from baseline at Day 85. The estimated Day 85 mean change from baseline and 95% confidence interval for the Placebo group was 1.8 (-0.8, 4.3).|||4.31|-2.77|0.979
72562209|NCT00407745|144655825|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.49|STANDARD_ERROR_OF_MEAN|0.23||0.0295|TWO_SIDED|95.0|-0.94|-0.05||Significance was declared if p-value \<=0.05|Mixed Models Analysis|||"Week 1~A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used.~Effects for treatment, study center, time (week), baseline pain score, baseline PCS total score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric."||-0.05|-0.94|0.0295
72562210|NCT00407745|144655825|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.67|STANDARD_ERROR_OF_MEAN|0.23||0.0033|TWO_SIDED|95.0|-1.11|-0.22||Significance was declared if p-value \<=0.05|Mixed Models Analysis|||"Week 2~A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used.~Effects for treatment, study center, time (week), baseline pain score, baseline PCS total score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric."||-0.22|-1.11|0.0033
72452535|NCT02307682|144427691|OTHER||Difference in proportions|2.0|||||TWO_SIDED|95.0|-2.1|6.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 76||6.0|-2.1|
72452536|NCT02307682|144427691|OTHER||Difference in proportions|-0.8|||||TWO_SIDED|95.0|-4.8|3.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 80||3.1|-4.8|
72452537|NCT02307682|144427691|OTHER||Difference in proportions|-0.2|||||TWO_SIDED|95.0|-4.6|3.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 80||3.9|-4.6|
72452538|NCT02307682|144427691|OTHER||Difference in proportions|1.4|||||TWO_SIDED|95.0|-2.6|5.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 84||5.4|-2.6|
72452539|NCT02307682|144427691|OTHER||Difference in proportions|0.6|||||TWO_SIDED|95.0|-3.7|4.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 84||4.4|-3.7|
72499322|NCT03093402|144529121|SUPERIORITY||Mean Difference (Final Values)|-1.44||||0.788|TWO_SIDED|95.0|-6.14|3.26||This p-value is from the overall 3 degree of freedom test that simultaneously compares the mean difference in the change from baseline PROMIS Anxiety T-Score at Day 85 for each of the 3 JBT-101 cohorts versus placebo.|Mixed Models Analysis||Estimated mean difference of High JBT-101 - Placebo in the mean change from baseline at Day 85. The estimated Day 85 mean change from baseline and 95% confidence interval for the Placebo group was -1.8 (-4.8, 1.2).|||3.26|-6.14|0.788
72452540|NCT02307682|144427691|OTHER||Difference in proportions|0.6|||||TWO_SIDED|95.0|-3.7|4.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 88||4.4|-3.7|
72452541|NCT02307682|144427691|OTHER||Difference in proportions|0.1|||||TWO_SIDED|95.0|-4.1|4.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 88||4.2|-4.1|
72499323|NCT03093402|144529121|SUPERIORITY||Mean Difference (Final Values)|-1.56||||0.788|TWO_SIDED|95.0|-6.07|2.96||This p-value is from the overall 3 degree of freedom test that simultaneously compares the mean difference in the change from baseline PROMIS Anxiety T-Score at Day 85 for each of the 3 JBT-101 cohorts versus placebo.|Mixed Models Analysis||Estimated mean difference of Medium JBT-101 - Placebo in the mean change from baseline at Day 85. The estimated Day 85 mean change from baseline and 95% confidence interval for the Placebo group was -1.8 (-4.8, 1.2).|||2.96|-6.07|0.788
72499324|NCT03093402|144529121|SUPERIORITY||Mean Difference (Final Values)|0.47||||0.788|TWO_SIDED|95.0|-4.0|4.94||This p-value is from the overall 3 degree of freedom test that simultaneously compares the mean difference in the change from baseline PROMIS Anxiety T-Score at Day 85 for each of the 3 JBT-101 cohorts versus placebo.|Mixed Models Analysis||Estimated mean difference of Low JBT-101 - Placebo in the mean change from baseline at Day 85. The estimated Day 85 mean change from baseline and 95% confidence interval for the Placebo group was -1.8 (-4.8, 1.2).|||4.94|-4.00|0.788
72499325|NCT03093402|144529122|SUPERIORITY||Mean Difference (Final Values)|-1.49||||0.766|TWO_SIDED|95.0|-6.14|3.16||This p-value is from the overall 3 degree of freedom test that simultaneously compares the mean difference in the change from baseline PROMIS Depression T-Score at Day 85 for each of the 3 JBT-101 cohorts versus placebo.|Mixed Models Analysis||Estimated mean difference of High JBT-101 - Placebo in the mean change from baseline at Day 85. The estimated Day 85 mean change from baseline and 95% confidence interval for the Placebo group was -1.7(-4.6, 1.3).|||3.16|-6.14|0.766
72499326|NCT03093402|144529122|SUPERIORITY||Mean Difference (Final Values)|0.76||||0.766|TWO_SIDED|95.0|-3.6|5.11||This p-value is from the overall 3 degree of freedom test that simultaneously compares the mean difference in the change from baseline PROMIS Depression T-Score at Day 85 for each of the 3 JBT-101 cohorts versus placebo.|Mixed Models Analysis||Estimated mean difference of Medium JBT-101 - Placebo in the mean change from baseline at Day 85. The estimated Day 85 change from baseline and 95% confidence interval for the Placebo group was -1.7(-4.6, 1.3).|||5.11|-3.60|0.766
72562211|NCT00407745|144655825|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.54|STANDARD_ERROR_OF_MEAN|0.23||0.0185|TWO_SIDED|95.0|-0.98|-0.09||Significance was declared if p-value \<=0.05|Mixed Models Analysis|||"Week 3~A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used.~Effects for treatment, study center, time (week), baseline pain score, baseline PCS total score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric."||-0.09|-0.98|0.0185
72562212|NCT00407745|144655825|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.66|STANDARD_ERROR_OF_MEAN|0.23||0.004|TWO_SIDED|95.0|-1.1|-0.21||Significance was declared if p-value \<=0.05|Mixed Models Analysis|||"Week 4~A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used.~Effects for treatment, study center, time (week), baseline pain score, baseline PCS total score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric."||-0.21|-1.10|0.0040
72622446|NCT02181413|144774860|SUPERIORITY||Hazard Ratio (HR)|0.7||||0.182|TWO_SIDED|95.0|0.414|1.184||P-value was based on log-rank test stratified by pre-induction regimen, ISS stage and response after transplantation.|Log Rank||Hazard ratio is based on an unadjusted Cox's proportional hazard regression model stratified by induction regimen, pre-induction ISS, and response after transplantation, comparing the hazard rate of Ixazomib arm over the hazard rate of Placebo arm.|MRD- at Study Entry||1.184|0.414|0.182
72622447|NCT02181413|144774860|SUPERIORITY||Hazard Ratio (HR)|0.966||||0.847|TWO_SIDED|95.0|0.682|1.368||P-value was based on log-rank test stratified by pre-induction regimen, ISS stage and response after transplantation.|Log Rank||Hazard ratio is based on an unadjusted Cox's proportional hazard regression model stratified by induction regimen, pre-induction ISS, and response after transplantation, comparing the hazard rate of Ixazomib arm over the hazard rate of Placebo arm.|MRD+ at Study Entry||1.368|0.682|0.847
72452542|NCT02307682|144427691|OTHER||Difference in proportions|1.7|||||TWO_SIDED|95.0|-2.2|5.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 92||5.5|-2.2|
72452543|NCT02307682|144427691|OTHER||Difference in proportions|1.2|||||TWO_SIDED|95.0|-3.0|5.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 92||5.1|-3.0|
72452544|NCT02307682|144427691|OTHER||Difference in proportions|1.1|||||TWO_SIDED|95.0|-2.9|4.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 96||4.9|-2.9|
72452545|NCT02307682|144427691|OTHER||Difference in proportions|0.7|||||TWO_SIDED|95.0|-3.6|4.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 96||4.6|-3.6|
72452546|NCT02307682|144427692|OTHER||Difference in proportions|-0.7|||||TWO_SIDED|95.0|-3.7|2.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 4||2.2|-3.7|
72452547|NCT02307682|144427692|OTHER||Difference in proportions|0.3|||||TWO_SIDED|95.0|-2.6|3.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 4||3.4|-2.6|
72452548|NCT02307682|144427692|OTHER||Difference in proportions|-0.6|||||TWO_SIDED|95.0|-3.3|2.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 8||2.3|-3.3|
72562213|NCT00407745|144655825|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.81|STANDARD_ERROR_OF_MEAN|0.23||0.0004|TWO_SIDED|95.0|-1.26|-0.36||Significance was declared if p-value \<=0.05|Mixed Models Analysis|||"Week 5~A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used.~Effects for treatment, study center, time (week), baseline pain score, baseline PCS total score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric."||-0.36|-1.26|0.0004
72562214|NCT00407745|144655825|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.72|STANDARD_ERROR_OF_MEAN|0.23||0.0018|TWO_SIDED|95.0|-1.17|-0.27||Significance was declared if p-value \<=0.05|Mixed Models Analysis|||"Week 6~A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used.~Effects for treatment, study center, time (week), baseline pain score, baseline PCS total score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric."||-0.27|-1.17|0.0018
72562215|NCT00407745|144655825|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.69|STANDARD_ERROR_OF_MEAN|0.23||0.0027|TWO_SIDED|95.0|-1.14|-0.24||Significance was declared if p-value \<=0.05|Mixed Models Analysis|||"Week 7~A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used.~Effects for treatment, study center, time (week), baseline pain score, baseline PCS total score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric."||-0.24|-1.14|0.0027
72562216|NCT00407745|144655825|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.66|STANDARD_ERROR_OF_MEAN|0.23||0.0041|TWO_SIDED|95.0|-1.11|-0.21||Significance was declared if p-value \<=0.05|Mixed Models Analysis|||"Week 8~A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used.~Effects for treatment, study center, time (week), baseline pain score, baseline PCS total score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric."||-0.21|-1.11|0.0041
72622448|NCT02181413|144774861|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.905|TWO_SIDED|95.0|0.583|1.613||P-value was based on log-rank test stratified by pre-induction regimen, ISS stage and response after transplantation.|Log Rank||Hazard ratio is based on an unadjusted Cox's proportional hazard regression model stratified by induction regimen, pre-induction ISS, and response after transplantation, comparing the hazard rate of Ixazomib arm over the hazard rate of Placebo arm.|||1.613|0.583|0.905
72622449|NCT02181413|144774866|SUPERIORITY||Least Squares (LS) Mean Difference|-2.3||||0.074|TWO_SIDED|95.0|-4.9|0.2|||t-test, 2 sided|P-value was from the significance test for the coefficient of the interaction between treatment and visit.||||0.2|-4.9|0.074
72452549|NCT02307682|144427692|OTHER||Difference in proportions|0.0|||||TWO_SIDED|95.0|-3.0|2.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 8||2.9|-3.0|
72452550|NCT02307682|144427692|OTHER||Difference in proportions|-1.2|||||TWO_SIDED|95.0|-4.6|2.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 12||2.4|-4.6|
72622450|NCT04806373|144774880|OTHER|||||||0.863|||||||Fisher Exact|||||||0.863
72452551|NCT02307682|144427692|OTHER||Difference in proportions|0.1|||||TWO_SIDED|95.0|-3.5|3.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 12||3.6|-3.5|
72622451|NCT04806373|144774881|OTHER|||||||0.005|||||||Wilcoxon (Mann-Whitney)|||Difference in pleural drainage volume day 1 post-TSP||||0.005
72452552|NCT02307682|144427692|OTHER||Difference in proportions|-0.6|||||TWO_SIDED|95.0|-4.2|2.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 16||2.9|-4.2|
72452553|NCT02307682|144427692|OTHER||Difference in proportions|-1.5|||||TWO_SIDED|95.0|-5.0|2.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 16||2.0|-5.0|
72452554|NCT02307682|144427692|OTHER||Difference in proportions|-0.9|||||TWO_SIDED|95.0|-4.1|2.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 20||2.4|-4.1|
72452555|NCT02307682|144427692|OTHER||Difference in proportions|1.1|||||TWO_SIDED|95.0|-2.3|4.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 20||4.7|-2.3|
72452556|NCT02307682|144427692|OTHER||Difference in proportions|-0.5|||||TWO_SIDED|95.0|-3.9|3.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 24||3.1|-3.9|
72452557|NCT02307682|144427692|OTHER||Difference in proportions|2.3|||||TWO_SIDED|95.0|-1.8|6.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 24||6.2|-1.8|
72452558|NCT02307682|144427692|OTHER||Difference in proportions|0.5|||||TWO_SIDED|95.0|-3.5|4.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 28||4.7|-3.5|
72452559|NCT02307682|144427692|OTHER||Difference in proportions|0.6|||||TWO_SIDED|95.0|-3.6|4.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 28||4.4|-3.6|
72622452|NCT04806373|144774882|OTHER|||||||0.891|||||||Wilcoxon (Mann-Whitney)|||Borg dyspnea scale day 3 post-TSP||||0.891
72452560|NCT02307682|144427692|OTHER||Difference in proportions|0.6|||||TWO_SIDED|95.0|-3.2|4.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 32||4.6|-3.2|
72452561|NCT02307682|144427692|OTHER||Difference in proportions|0.6|||||TWO_SIDED|95.0|-3.2|4.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 32||4.5|-3.2|
72452562|NCT02307682|144427692|OTHER||Difference in proportions|1.2|||||TWO_SIDED|95.0|-2.6|5.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 36||5.3|-2.6|
72452563|NCT02307682|144427692|OTHER||Difference in proportions|1.9|||||TWO_SIDED|95.0|-2.1|5.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 36||5.9|-2.1|
72452564|NCT02307682|144427692|OTHER||Difference in proportions|-0.2|||||TWO_SIDED|95.0|-4.3|3.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 40||3.9|-4.3|
72452565|NCT02307682|144427692|OTHER||Difference in proportions|0.8|||||TWO_SIDED|95.0|-3.6|4.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 40||4.8|-3.6|
72452566|NCT02307682|144427692|OTHER||Difference in proportions|0.6|||||TWO_SIDED|95.0|-3.7|4.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 44||4.8|-3.7|
72452567|NCT02307682|144427692|OTHER||Difference in proportions|0.7|||||TWO_SIDED|95.0|-3.7|4.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 44||4.7|-3.7|
72452568|NCT02307682|144427692|OTHER||Difference in proportions|1.9|||||TWO_SIDED|95.0|-2.2|6.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 48||6.1|-2.2|
72622453|NCT04806373|144774883|OTHER|||||||0.899|||||||Wilcoxon (Mann-Whitney)|||Pain score at day 3 post-TSP||||0.899
72622454|NCT04806373|144774884|OTHER|||||||0.809|||||||Fisher Exact|||||||0.809
72622455|NCT04806373|144774885|OTHER|||||||0.946|||||||Wilcoxon (Mann-Whitney)|||||||0.946
72452569|NCT02307682|144427692|OTHER||Difference in proportions|1.3|||||TWO_SIDED|95.0|-2.9|5.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 48||5.3|-2.9|
72452570|NCT02307682|144427692|OTHER||Difference in proportions|0.6|||||TWO_SIDED|95.0|-3.5|4.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 52||4.8|-3.5|
72452571|NCT02307682|144427692|OTHER||Difference in proportions|3.0|||||TWO_SIDED|95.0|-1.6|7.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 52||7.3|-1.6|
72452572|NCT02307682|144427692|OTHER||Difference in proportions|2.0|||||TWO_SIDED|95.0|-2.3|6.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 56||6.2|-2.3|
72452573|NCT02307682|144427692|OTHER||Difference in proportions|2.5|||||TWO_SIDED|95.0|-2.2|6.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 56||6.7|-2.2|
72452574|NCT02307682|144427692|OTHER||Difference in proportions|-0.4|||||TWO_SIDED|95.0|-4.8|3.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 60||3.8|-4.8|
72452575|NCT02307682|144427692|OTHER||Difference in proportions|1.2|||||TWO_SIDED|95.0|-3.8|5.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 60||5.9|-3.8|
72452576|NCT02307682|144427692|OTHER||Difference in proportions|1.4|||||TWO_SIDED|95.0|-3.1|5.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 64||5.7|-3.1|
72452577|NCT02307682|144427692|OTHER||Difference in proportions|2.0|||||TWO_SIDED|95.0|-2.8|6.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 64||6.4|-2.8|
72452578|NCT02307682|144427692|OTHER||Difference in proportions|1.1|||||TWO_SIDED|95.0|-3.4|5.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 68||5.2|-3.4|
72452579|NCT02307682|144427692|OTHER||Difference in proportions|2.3|||||TWO_SIDED|95.0|-2.8|6.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 68||6.6|-2.8|
72452580|NCT02307682|144427692|OTHER||Difference in proportions|-1.9|||||TWO_SIDED|95.0|-6.6|2.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 72||2.5|-6.6|
72452581|NCT02307682|144427692|OTHER||Difference in proportions|-0.9|||||TWO_SIDED|95.0|-6.1|3.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 72||3.8|-6.1|
72452582|NCT02307682|144427692|OTHER||Difference in proportions|-1.1|||||TWO_SIDED|95.0|-5.6|3.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 76||3.1|-5.6|
72452583|NCT02307682|144427692|OTHER||Difference in proportions|2.3|||||TWO_SIDED|95.0|-2.9|6.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 76||6.9|-2.9|
72452584|NCT02307682|144427692|OTHER||Difference in proportions|-1.2|||||TWO_SIDED|95.0|-5.8|3.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 80||3.1|-5.8|
72452585|NCT02307682|144427692|OTHER||Difference in proportions|1.7|||||TWO_SIDED|95.0|-3.2|6.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 80||6.5|-3.2|
72452586|NCT02307682|144427692|OTHER||Difference in proportions|0.5|||||TWO_SIDED|95.0|-4.2|5.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 84||5.0|-4.2|
72391652|NCT01447433|144290647|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.98|STANDARD_ERROR_OF_MEAN|0.85||0.255|TWO_SIDED|95.0|-0.74|2.7|||t-test, 2 sided|||Hip Circumference||2.70|-0.74|0.255
72499327|NCT03093402|144529122|SUPERIORITY||Mean Difference (Final Values)|-1.24||||0.766|TWO_SIDED|95.0|-5.55|3.07||This p-value is from the overall 3 degree of freedom test that simultaneously compares the mean difference in the change from baseline PROMIS Depression T-Score at Day 85 for each of the 3 JBT-101 cohorts versus placebo.|Mixed Models Analysis||Estimated mean difference of Low JBT-101 - Placebo in the mean change from baseline at Day 85. The estimated Day 85 change from baseline and 95% confidence interval for the Placebo group was -1.7(-4.6, 1.3).|||3.07|-5.55|0.766
72452587|NCT02307682|144427692|OTHER||Difference in proportions|1.9|||||TWO_SIDED|95.0|-3.2|6.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 84||6.7|-3.2|
72452588|NCT02307682|144427692|OTHER||Difference in proportions|-0.5|||||TWO_SIDED|95.0|-5.8|4.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 88||4.2|-5.8|
72452589|NCT02307682|144427692|OTHER||Difference in proportions|0.1|||||TWO_SIDED|95.0|-5.2|4.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 88||4.6|-5.2|
72452590|NCT02307682|144427692|OTHER||Difference in proportions|-0.6|||||TWO_SIDED|95.0|-5.5|4.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 92||4.1|-5.5|
72452591|NCT02307682|144427692|OTHER||Difference in proportions|-0.2|||||TWO_SIDED|95.0|-5.3|4.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 92||4.4|-5.3|
72452592|NCT02307682|144427692|OTHER||Difference in proportions|-0.8|||||TWO_SIDED|95.0|-5.7|4.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 96||4.4|-5.7|
72452593|NCT02307682|144427692|OTHER||Difference in proportions|2.1|||||TWO_SIDED|95.0|-3.4|7.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 96||7.3|-3.4|
72452594|NCT02307682|144427693|OTHER||Difference in proportions|1.6|||||TWO_SIDED|95.0|-2.4|5.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 4||5.5|-2.4|
72452595|NCT02307682|144427693|OTHER||Difference in proportions|2.4|||||TWO_SIDED|95.0|-1.8|6.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 4||6.8|-1.8|
72452596|NCT02307682|144427693|OTHER||Difference in proportions|-0.2|||||TWO_SIDED|95.0|-4.1|3.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 8||3.8|-4.1|
72499328|NCT03093402|144529123|SUPERIORITY||Mean Difference (Final Values)|-0.44||||0.982|TWO_SIDED|95.0|-6.04|5.17||This p-value is from the overall 3 degree of freedom test that simultaneously compares the mean difference in the change from baseline PROMIS Fatigue T-Score at Day 85 for each of the 3 JBT-101 cohorts versus placebo.|Mixed Models Analysis||Estimated mean difference of High JBT-101 - Placebo in the mean change from baseline at Day 85. The estimated Day 85 mean change from baseline and 95% confidence interval for the Placebo group was -4.7 (-8.3, -1.1).|||5.17|-6.04|0.982
72452597|NCT02307682|144427693|OTHER||Difference in proportions|2.7|||||TWO_SIDED|95.0|-1.7|6.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 8||6.8|-1.7|
72622456|NCT04806373|144774886|OTHER|||||||0.808|||||||Wilcoxon (Mann-Whitney)|||||||0.808
72391653|NCT01447433|144290648|SUPERIORITY_OR_OTHER||Median Difference (Net)|-3.8|STANDARD_ERROR_OF_MEAN|4.5||0.404|TWO_SIDED|95.0|-12.9|5.3|||t-test, 2 sided|||Systolic Blood Pressure||5.3|-12.9|0.404
72452598|NCT02307682|144427693|OTHER||Difference in proportions|1.8|||||TWO_SIDED|95.0|-2.3|6.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 12||6.5|-2.3|
72452599|NCT02307682|144427693|OTHER||Difference in proportions|3.4|||||TWO_SIDED|95.0|-0.9|7.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 12||7.9|-0.9|
72622457|NCT04806373|144774887|OTHER|||||||0.662|||||||Fisher Exact|||||||0.662
72622458|NCT04806373|144774888|OTHER|||||||0.714|||||||t-test, 2 sided|||||||0.714
72622459|NCT04806373|144774889|OTHER|||||||1|||||||Fisher Exact|||||||1.0
72620043|NCT01793129|144771096|SUPERIORITY|This trial estimated the probability that the intervention has no effect on the outcome (or conversely, the probability that id does), given the data obtained in the trial and any prior evidence.|Risk Ratio (RR)|1.11|||||TWO_SIDED|95.0|0.74|2.0|||||The relative risk estimate was calculated by dividing risk under hypothermia by risk under normothermia.|Whole-body Hypothermia vs. Normothermia (Normothermia is the comparison group)|To get estimates of RR from the Bayesian logistic regression model, predicted probabilities of the outcome were generated for all infants assuming the infants were treated with and without hypothermia and with/without severe encephalopathy. Next subject level RR values were estimated for all infants and 2.5, 50, and 97.5 percentiles were calculated.|2.00|0.74|
72620044|NCT03681093|144771102|SUPERIORITY||Least Squares (LS) Mean|0.05|STANDARD_ERROR_OF_MEAN|0.323||0.979|TWO_SIDED|95.0|-0.59|0.7||Adjusted p-value is reported. The adjusted p-value was obtained from the Dunnet Multiplicity Correction applied to control the Type I error for the primary analysis.|Mixed Model for Repeated Measures (MMRM)|||||0.70|-0.59|0.979
72620045|NCT03681093|144771102|SUPERIORITY||LS Mean|-0.25|STANDARD_ERROR_OF_MEAN|0.319||0.656|TWO_SIDED|95.0|-0.88|0.39||Adjusted p-value is reported. The adjusted p-value was obtained from the Dunnet Multiplicity Correction applied to control the Type I error for the primary analysis.|MMRM|||||0.39|-0.88|0.656
72620046|NCT03681093|144771103|SUPERIORITY||LS Mean|0.64|STANDARD_ERROR_OF_MEAN|0.249||0.012|TWO_SIDED|95.0|0.15|1.14||Unadjusted p-value|MMRM|||||1.14|0.15|0.012
72620047|NCT03681093|144771103|SUPERIORITY||LS Mean|0.45|STANDARD_ERROR_OF_MEAN|0.248||0.074|TWO_SIDED|95.0|-0.04|0.94||Unadjusted p-value|MMRM|||||0.94|-0.04|0.074
72620048|NCT03681093|144771104|SUPERIORITY||LS Mean|5.22|STANDARD_ERROR_OF_MEAN|4.881||0.288|TWO_SIDED|95.0|-4.49|14.93||Unadjusted p-value|MMRM|||||14.93|-4.49|0.288
72620049|NCT03681093|144771104|SUPERIORITY||LS Mean|-2.17|STANDARD_ERROR_OF_MEAN|4.936||0.661|TWO_SIDED|95.0|-11.99|7.65||Unadjusted p-value|MMRM|||||7.65|-11.99|0.661
72620050|NCT03681093|144771105|SUPERIORITY||LS Mean|0.61|STANDARD_ERROR_OF_MEAN|1.809||0.735|TWO_SIDED|95.0|-2.98|4.21||Unadjusted p-value|MMRM|||||4.21|-2.98|0.735
72452600|NCT02307682|144427693|OTHER||Difference in proportions|-0.7|||||TWO_SIDED|95.0|-5.4|4.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 16||4.0|-5.4|
72452601|NCT02307682|144427693|OTHER||Difference in proportions|-1.6|||||TWO_SIDED|95.0|-6.2|3.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 16||3.2|-6.2|
72452602|NCT02307682|144427693|OTHER||Difference in proportions|-1.3|||||TWO_SIDED|95.0|-5.4|3.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 20||3.3|-5.4|
72452603|NCT02307682|144427693|OTHER||Difference in proportions|2.0|||||TWO_SIDED|95.0|-2.9|6.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 20||6.4|-2.9|
72452604|NCT02307682|144427693|OTHER||Difference in proportions|-0.8|||||TWO_SIDED|95.0|-5.2|3.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 24||3.9|-5.2|
72452605|NCT02307682|144427693|OTHER||Difference in proportions|3.8|||||TWO_SIDED|95.0|-1.4|8.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 24||8.8|-1.4|
72452606|NCT02307682|144427693|OTHER||Difference in proportions|-2.3|||||TWO_SIDED|95.0|-6.8|2.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 28||2.3|-6.8|
72452607|NCT02307682|144427693|OTHER||Difference in proportions|0.8|||||TWO_SIDED|95.0|-4.7|5.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 28||5.8|-4.7|
72620051|NCT03681093|144771105|SUPERIORITY||LS Mean|4.51|STANDARD_ERROR_OF_MEAN|1.821||0.015|TWO_SIDED|95.0|0.89|8.13||Unadjusted p-value|MMRM|||||8.13|0.89|0.015
72620052|NCT05033561|144771106|NON_INFERIORITY|Non-inferiority would be verified if the lower bound of the two-sided 95% CI around each difference (shorter interval minus standard interval) is greater than -10%.||||||0.05||||||This is the nominal alpha level for the two-sided confidence interval comparison.|Miettinen-Nurminen|Pairwise comparisons with two-sided Miettinen-Nurminen confidence intervals.||This study was designed to demonstrate the non-inferiority of Group A (1-week interval nOPV2 administration) and Group B (2-weeks interval nOPV2 administration) versus Group C (standard 4-week interval).||||0.05
72620053|NCT05033561|144771106|NON_INFERIORITY|Non-inferiority would be verified if the lower bound of the two-sided 95% CI around each difference (shorter interval minus standard interval) is greater than -10%.||||||0.05||||||This is the nominal alpha level for the two-sided confidence interval comparison.|Miettinen-Nurminen|Pairwise comparisons with two-sided Miettinen-Nurminen confidence intervals.||This study was designed to demonstrate the non-inferiority of Group A (1-week interval nOPV2 administration) and Group B (2-weeks interval nOPV2 administration) versus Group C (standard 4-week interval).||||0.05
72452608|NCT02307682|144427693|OTHER||Difference in proportions|-0.5|||||TWO_SIDED|95.0|-5.0|4.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 32||4.4|-5.0|
72452609|NCT02307682|144427693|OTHER||Difference in proportions|-1.1|||||TWO_SIDED|95.0|-6.1|4.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 32||4.0|-6.1|
72452610|NCT02307682|144427693|OTHER||Difference in proportions|2.8|||||TWO_SIDED|95.0|-1.8|7.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 36||7.7|-1.8|
72452611|NCT02307682|144427693|OTHER||Difference in proportions|2.1|||||TWO_SIDED|95.0|-2.7|6.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 36||6.8|-2.7|
72452612|NCT02307682|144427693|OTHER||Difference in proportions|-1.1|||||TWO_SIDED|95.0|-5.9|4.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 40||4.0|-5.9|
72452613|NCT02307682|144427693|OTHER||Difference in proportions|0.4|||||TWO_SIDED|95.0|-4.7|4.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 40||4.9|-4.7|
72452614|NCT02307682|144427693|OTHER||Difference in proportions|-0.7|||||TWO_SIDED|95.0|-5.7|4.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 44||4.5|-5.7|
72452615|NCT02307682|144427693|OTHER||Difference in proportions|-1.6|||||TWO_SIDED|95.0|-6.5|3.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 44||3.3|-6.5|
72452616|NCT02307682|144427693|OTHER||Difference in proportions|2.1|||||TWO_SIDED|95.0|-2.7|6.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 48||6.9|-2.7|
72452617|NCT02307682|144427693|OTHER||Difference in proportions|0.8|||||TWO_SIDED|95.0|-4.3|5.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 48||5.4|-4.3|
72452618|NCT02307682|144427693|OTHER||Difference in proportions|0.2|||||TWO_SIDED|95.0|-4.6|5.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 52||5.3|-4.6|
72452619|NCT02307682|144427693|OTHER||Difference in proportions|1.6|||||TWO_SIDED|95.0|-3.9|6.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 52||6.6|-3.9|
72452620|NCT02307682|144427693|OTHER||Difference in proportions|0.9|||||TWO_SIDED|95.0|-4.0|6.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 56||6.1|-4.0|
72452621|NCT02307682|144427693|OTHER||Difference in proportions|1.5|||||TWO_SIDED|95.0|-3.8|6.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 56||6.2|-3.8|
72452622|NCT02307682|144427693|OTHER||Difference in proportions|0.4|||||TWO_SIDED|95.0|-4.5|5.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 60||5.6|-4.5|
72452623|NCT02307682|144427693|OTHER||Difference in proportions|1.7|||||TWO_SIDED|95.0|-3.8|6.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 60||6.8|-3.8|
72452624|NCT02307682|144427693|OTHER||Difference in proportions|2.2|||||TWO_SIDED|95.0|-2.9|7.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 64||7.3|-2.9|
72452625|NCT02307682|144427693|OTHER||Difference in proportions|2.9|||||TWO_SIDED|95.0|-2.8|7.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 64||7.9|-2.8|
72452626|NCT02307682|144427693|OTHER||Difference in proportions|-0.5|||||TWO_SIDED|95.0|-5.5|4.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 68||4.5|-5.5|
72452627|NCT02307682|144427693|OTHER||Difference in proportions|0.5|||||TWO_SIDED|95.0|-5.1|5.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 68||5.3|-5.1|
72452628|NCT02307682|144427693|OTHER||Difference in proportions|1.2|||||TWO_SIDED|95.0|-4.3|6.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 72||6.7|-4.3|
72452629|NCT02307682|144427693|OTHER||Difference in proportions|0.5|||||TWO_SIDED|95.0|-5.2|5.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 72||5.6|-5.2|
72452630|NCT02307682|144427693|OTHER||Difference in proportions|0.9|||||TWO_SIDED|95.0|-4.6|6.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 76||6.4|-4.6|
72452631|NCT02307682|144427693|OTHER||Difference in proportions|1.2|||||TWO_SIDED|95.0|-4.7|6.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 76||6.3|-4.7|
72452632|NCT02307682|144427693|OTHER||Difference in proportions|0.7|||||TWO_SIDED|95.0|-4.8|6.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 80||6.2|-4.8|
72452633|NCT02307682|144427693|OTHER||Difference in proportions|1.1|||||TWO_SIDED|95.0|-4.8|6.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 80||6.2|-4.8|
72499329|NCT03093402|144529123|SUPERIORITY||Mean Difference (Final Values)|-0.86||||0.982|TWO_SIDED|95.0|-6.22|4.5||This p-value is from the overall 3 degree of freedom test that simultaneously compares the mean difference in the change from baseline PROMIS Fatigue T-Score at Day 85 for each of the 3 JBT-101 cohorts versus placebo.|Mixed Models Analysis||Estimated mean difference of Medium JBT-101 - Placebo in the mean change from baseline at Day 85. The estimated Day 85 mean change from baseline and 95% confidence interval for the Placebo group was -4.7 (-8.3, -1.1).|Each active JBT-101 cohort is compared to placebo.||4.50|-6.22|0.982
72499330|NCT03093402|144529123|SUPERIORITY||Mean Difference (Final Values)|-0.98||||0.982|TWO_SIDED|95.0|-6.32|4.36||This p-value is from the overall 3 degree of freedom test that simultaneously compares the mean difference in the change from baseline PROMIS Fatigue T-Score at Day 85 for each of the 3 JBT-101 cohorts versus placebo.|Mixed Models Analysis||Estimated mean difference of Low JBT-101 - Placebo in the mean change from baseline at Day 85. The estimated Day 85 mean change from baseline and 95% confidence interval for the Placebo group was -4.7 (-8.3, -1.1).|||4.36|-6.32|0.982
72620054|NCT05033561|144771107|NON_INFERIORITY|Non-inferiority would be verified if the lower bound of the two-sided 95% CI around each difference (shorter interval minus standard interval) is greater than -10%.||||||0.05||||||This is the nominal alpha level for the two-sided confidence interval comparison.|Miettinen-Nurminen|Pairwise comparisons with two-sided Miettinen-Nurminen confidence intervals.||This study was designed to demonstrate the non-inferiority of Group A (1-week interval nOPV2 administration) and Group B (2-weeks interval nOPV2 administration) versus Group C (standard 4-week interval).||||0.05
72452634|NCT02307682|144427693|OTHER||Difference in proportions|2.2|||||TWO_SIDED|95.0|-3.1|7.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 84||7.7|-3.1|
72452635|NCT02307682|144427693|OTHER||Difference in proportions|3.3|||||TWO_SIDED|95.0|-2.9|8.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 84||8.7|-2.9|
72452636|NCT02307682|144427693|OTHER||Difference in proportions|0.9|||||TWO_SIDED|95.0|-4.5|6.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 88||6.4|-4.5|
72452637|NCT02307682|144427693|OTHER||Difference in proportions|1.4|||||TWO_SIDED|95.0|-4.6|6.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 88||6.4|-4.6|
72452638|NCT02307682|144427693|OTHER||Difference in proportions|1.3|||||TWO_SIDED|95.0|-4.5|6.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 92||6.9|-4.5|
72452639|NCT02307682|144427693|OTHER||Difference in proportions|1.4|||||TWO_SIDED|95.0|-4.5|6.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 92||6.4|-4.5|
72499331|NCT03093402|144529124|SUPERIORITY||Mean Difference (Final Values)|0.09||||0.607|TWO_SIDED|95.0|-4.74|4.91||This p-value is from the overall 3 degree of freedom test that simultaneously compares the mean difference in the change from baseline PROMIS Sleep Disturbance T-Score at Day 85 for each of the 3 JBT-101 cohorts versus placebo.|Mixed Models Analysis||Estimated mean difference of High JBT-101 - Placebo in the mean change from baseline at Day 85. The estimated Day 85 change from baseline and 95% confidence interval for the Placebo group was -3.5 (-6.8, -0.3).|Each active JBT-101 cohort is compared to placebo.||4.91|-4.74|0.607
72499332|NCT03093402|144529124|SUPERIORITY||Mean Difference (Final Values)|2.93||||0.607|TWO_SIDED|95.0|-1.85|7.71||This p-value is from the overall 3 degree of freedom test that simultaneously compares the mean difference in the change from baseline PROMIS Sleep Disturbance T-Score at Day 85 for each of the 3 JBT-101 cohorts versus placebo.|Mixed Models Analysis||Estimated mean difference of Medium JBT-101 - Placebo in the mean change from baseline at Day 85. The estimated Day 85 change from baseline and 95% confidence interval for the Placebo group was -3.5 (-6.8, -0.3).|Each active JBT-101 cohort is compared to placebo.||7.71|-1.85|0.607
72562217|NCT00407745|144655825|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.64|STANDARD_ERROR_OF_MEAN|0.23||0.0058|TWO_SIDED|95.0|-1.09|-0.18||Significance was declared if p-value \<=0.05|Mixed Models Analysis|||"Week 9~A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used.~Effects for treatment, study center, time (week), baseline pain score, baseline PCS total score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric."||-0.18|-1.09|0.0058
72562218|NCT00407745|144655825|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.69|STANDARD_ERROR_OF_MEAN|0.23||0.0031|TWO_SIDED|95.0|-1.14|-0.23||Significance was declared if p-value \<=0.05|Mixed Models Analysis|||"Week 10~A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used.~Effects for treatment, study center, time (week), baseline pain score, baseline PCS total score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric."||-0.23|-1.14|0.0031
72452640|NCT02307682|144427693|OTHER||Difference in proportions|2.8|||||TWO_SIDED|95.0|-3.1|8.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 96||8.7|-3.1|
72452641|NCT02307682|144427693|OTHER||Difference in proportions|1.6|||||TWO_SIDED|95.0|-4.7|7.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 96||7.2|-4.7|
72562219|NCT00407745|144655825|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.62|STANDARD_ERROR_OF_MEAN|0.23||0.0076|TWO_SIDED|95.0|-1.08|-0.17||Significance was declared if p-value \<=0.05|Mixed Models Analysis|||"Week 11~A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used.~Effects for treatment, study center, time (week), baseline pain score, baseline PCS total score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric."||-0.17|-1.08|0.0076
72562220|NCT00407745|144655825|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.23||0.0328|TWO_SIDED|95.0|-0.95|-0.04||Significance was declared if p-value \<=0.05|Mixed Models Analysis|||"Week 12~A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used.~Effects for treatment, study center, time (week), baseline pain score, baseline PCS total score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric."||-0.04|-0.95|0.0328
72562221|NCT00407745|144655825|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.57|STANDARD_ERROR_OF_MEAN|0.23||0.015|TWO_SIDED|95.0|-1.02|-0.11||Significance was declared if p-value \<=0.05|Mixed Models Analysis|||"Week 13~A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used.~Effects for treatment, study center, time (week), baseline pain score, baseline PCS total score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric."||-0.11|-1.02|0.0150
72452642|NCT02307682|144427694|OTHER||Difference in proportions|-2.1|||||TWO_SIDED|95.0|-7.7|3.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 4||3.5|-7.7|
72499333|NCT03093402|144529124|SUPERIORITY||Mean Difference (Final Values)|1.44||||0.607|TWO_SIDED|95.0|-3.22|6.09||This p-value is from the overall 3 degree of freedom test that simultaneously compares the mean difference in the change from baseline PROMIS Sleep Disturbance T-Score at Day 85 for each of the 3 JBT-101 cohorts versus placebo.|Mixed Models Analysis||Estimated mean difference of Low JBT-101 - Placebo in the mean change from baseline at Day 85. The estimated Day 85 change from baseline and 95% confidence interval for the Placebo group was -3.5 (-6.8, -0.3).|Each active JBT-101 cohort is compared to placebo.||6.09|-3.22|0.607
72452643|NCT02307682|144427694|OTHER||Difference in proportions|-2.7|||||TWO_SIDED|95.0|-8.5|2.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 4||2.8|-8.5|
72452644|NCT02307682|144427694|OTHER||Difference in proportions|-3.0|||||TWO_SIDED|95.0|-8.9|2.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 8||2.6|-8.9|
72562222|NCT00407745|144655825|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.66|STANDARD_ERROR_OF_MEAN|0.23||0.0048|TWO_SIDED|95.0|-1.11|-0.2||Significance was declared if p-value \<=0.05|Mixed Models Analysis|||"Week 14~A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used.~Effects for treatment, study center, time (week), baseline pain score, baseline PCS total score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric."||-0.20|-1.11|0.0048
72562223|NCT00407745|144655825|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.69|STANDARD_ERROR_OF_MEAN|0.23||0.003|TWO_SIDED|95.0|-1.15|-0.24||Significance was declared if p-value \<=0.05|Mixed Models Analysis|||"Week 15~A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used.~Effects for treatment, study center, time (week), baseline pain score, baseline PCS total score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric."||-0.24|-1.15|0.0030
72562224|NCT00407745|144655825|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.76|STANDARD_ERROR_OF_MEAN|0.23||0.0011|TWO_SIDED|95.0|-1.22|-0.3||Significance was declared if p-value \<=0.05|Mixed Models Analysis|||"Week 16~A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used.~Effects for treatment, study center, time (week), baseline pain score, baseline PCS total score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric."||-0.30|-1.22|0.0011
72562225|NCT00407745|144655826|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.24||||0.0256|TWO_SIDED|95.0|1.103|4.546||Significance was declared if p-value \<=0.05|Regression, Logistic|Logistic regression used terms for treatment, baseline pain score as covariate, baseline PCS total score, and pooled center as cofactor.||Null hypothesis - The rate of responder for the pregabain group was equal to the rate of responder for the placebo group; Alternative hypothesis - The rate of responder for the pregabain group was not equal to the rate of responder for the placebo group.||4.546|1.103|0.0256
72620055|NCT05033561|144771107|NON_INFERIORITY|Non-inferiority would be verified if the lower bound of the two-sided 95% CI around each difference (shorter interval minus standard interval) is greater than -10%.||||||0.05||||||This is the nominal alpha level for the two-sided confidence interval comparison.|Miettinen-Nurminen|Pairwise comparisons with two-sided Miettinen-Nurminen confidence intervals.||This study was designed to demonstrate the non-inferiority of Group A (1-week interval nOPV2 administration) and Group B (2-weeks interval nOPV2 administration) versus Group C (standard 4-week interval).||||0.05
72452645|NCT02307682|144427694|OTHER||Difference in proportions|-2.1|||||TWO_SIDED|95.0|-7.7|3.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 8||3.6|-7.7|
72452646|NCT02307682|144427694|OTHER||Difference in proportions|-3.1|||||TWO_SIDED|95.0|-8.9|2.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 12||2.4|-8.9|
72452647|NCT02307682|144427694|OTHER||Difference in proportions|-4.0|||||TWO_SIDED|95.0|-10.0|2.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 12||2.0|-10.0|
72452648|NCT02307682|144427694|OTHER||Difference in proportions|-0.5|||||TWO_SIDED|95.0|-6.3|5.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 16||5.5|-6.3|
72452649|NCT02307682|144427694|OTHER||Difference in proportions|0.1|||||TWO_SIDED|95.0|-6.2|6.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 16||6.4|-6.2|
72452650|NCT02307682|144427694|OTHER||Difference in proportions|-4.0|||||TWO_SIDED|95.0|-10.4|2.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 20||2.0|-10.4|
72452651|NCT02307682|144427694|OTHER||Difference in proportions|-3.4|||||TWO_SIDED|95.0|-9.4|2.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 20||2.8|-9.4|
72452652|NCT02307682|144427694|OTHER||Difference in proportions|1.1|||||TWO_SIDED|95.0|-4.6|6.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 24||6.9|-4.6|
72452653|NCT02307682|144427694|OTHER||Difference in proportions|-0.6|||||TWO_SIDED|95.0|-6.6|5.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 24||5.7|-6.6|
72452654|NCT02307682|144427694|OTHER||Difference in proportions|-0.1|||||TWO_SIDED|95.0|-6.5|5.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 28||5.7|-6.5|
72452655|NCT02307682|144427694|OTHER||Difference in proportions|1.1|||||TWO_SIDED|95.0|-4.9|7.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 28||7.4|-4.9|
72452656|NCT02307682|144427694|OTHER||Difference in proportions|1.6|||||TWO_SIDED|95.0|-3.9|7.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 32||7.5|-3.9|
72452657|NCT02307682|144427694|OTHER||Difference in proportions|5.1|||||TWO_SIDED|95.0|-1.0|11.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 32||11.5|-1.0|
72620056|NCT02006836|144771129|SUPERIORITY_OR_OTHER|||||||0.005|||||||t-test, 1 sided|||H0: GI of pomelo for diabetic patients - GI of pomelo for healthy people = 0 H1: GI of pomelo for diabetic patients - GI of pomelo for healthy people \> 0 α=5%||||0.005
72452658|NCT02307682|144427694|OTHER||Difference in proportions|-2.4|||||TWO_SIDED|95.0|-8.5|3.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 36||3.4|-8.5|
72452659|NCT02307682|144427694|OTHER||Difference in proportions|0.4|||||TWO_SIDED|95.0|-6.0|6.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 36||6.4|-6.0|
72452660|NCT02307682|144427694|OTHER||Difference in proportions|1.0|||||TWO_SIDED|95.0|-5.2|6.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 40||6.4|-5.2|
72452661|NCT02307682|144427694|OTHER||Difference in proportions|-1.2|||||TWO_SIDED|95.0|-7.4|5.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 40||5.0|-7.4|
72452662|NCT02307682|144427694|OTHER||Difference in proportions|-2.4|||||TWO_SIDED|95.0|-8.8|3.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 44||3.5|-8.8|
72452663|NCT02307682|144427694|OTHER||Difference in proportions|-2.2|||||TWO_SIDED|95.0|-8.4|4.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 44||4.2|-8.4|
72452664|NCT02307682|144427694|OTHER||Difference in proportions|-3.5|||||TWO_SIDED|95.0|-9.5|2.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 48||2.3|-9.5|
72452665|NCT02307682|144427694|OTHER||Difference in proportions|-2.4|||||TWO_SIDED|95.0|-8.6|3.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 48||3.6|-8.6|
72452666|NCT02307682|144427694|OTHER||Difference in proportions|-2.4|||||TWO_SIDED|95.0|-8.8|3.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 52||3.2|-8.8|
72452667|NCT02307682|144427694|OTHER||Difference in proportions|-0.5|||||TWO_SIDED|95.0|-6.8|6.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 52||6.1|-6.8|
72452668|NCT02307682|144427694|OTHER||Difference in proportions|0.2|||||TWO_SIDED|95.0|-5.9|6.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 56||6.1|-5.9|
72452669|NCT02307682|144427694|OTHER||Difference in proportions|-0.6|||||TWO_SIDED|95.0|-6.6|6.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 56||6.0|-6.6|
72499334|NCT03093402|144529125|SUPERIORITY||Mean Difference (Final Values)|-0.18||||0.981|TWO_SIDED|95.0|-4.66|4.3||This p-value is from the overall 3 degree of freedom test that simultaneously compares the mean difference in the change from baseline PROMIS Social Role Satisfaction T-Score at Day 85 for each of the 3 JBT-101 cohorts versus placebo.|Mixed Models Analysis||Estimated mean difference of High JBT-101 - Placebo in the mean change from baseline at Day 85. The estimated Day 85 change from baseline and 95% confidence interval for the Placebo group was 4.2 (0.8, 7.6).|||4.30|-4.66|0.981
72499335|NCT03093402|144529125|SUPERIORITY||Mean Difference (Final Values)|0.51||||0.981|TWO_SIDED|95.0|-3.84|4.86||This p-value is from the overall 3 degree of freedom test that simultaneously compares the mean difference in the change from baseline PROMIS Social Role Satisfaction T-Score at Day 85 for each of the 3 JBT-101 cohorts versus placebo.|Mixed Models Analysis||Estimated mean difference of Medium JBT-101 - Placebo in the mean change from baseline at Day 85. The estimated Day 85 change from baseline and 95% confidence interval for the Placebo group was 4.2 (0.8, 7.6).|||4.86|-3.84|0.981
72499336|NCT03093402|144529125|SUPERIORITY||Mean Difference (Final Values)|-0.27||||0.981|TWO_SIDED|95.0|-4.62|4.08||This p-value is from the overall 3 degree of freedom test that simultaneously compares the mean difference in the change from baseline PROMIS Social Role Satisfaction T-Score at Day 85 for each of the 3 JBT-101 cohorts versus placebo.|Mixed Models Analysis||Estimated mean difference of Low JBT-101 - Placebo in the mean change from baseline at Day 85. The estimated Day 85 change from baseline and 95% confidence interval for the Placebo group was 4.2 (0.8, 7.6).|||4.08|-4.62|0.981
72499337|NCT03093402|144529126|SUPERIORITY||Mean Difference (Final Values)|-1.85||||0.653|TWO_SIDED|95.0|-6.0|2.29||This p-value is from the overall 3 degree of freedom test that simultaneously compares the mean difference in the change from baseline PROMIS Pain Interference T-Score at Day 85 for each of the 3 JBT-101 cohorts versus placebo.|Mixed Models Analysis||Estimated mean difference of High JBT-101 - Placebo in the mean change from baseline at Day 85. The estimated Day 85 change from baseline and 95% confidence interval for the Placebo group was -4.9 (-7.6, -2.1).|Each active JBT-101 cohort is compared to placebo.||2.29|-6.00|0.653
72452670|NCT02307682|144427694|OTHER||Difference in proportions|0.6|||||TWO_SIDED|95.0|-5.7|6.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 60||6.4|-5.7|
72452671|NCT02307682|144427694|OTHER||Difference in proportions|-3.0|||||TWO_SIDED|95.0|-9.0|3.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 60||3.1|-9.0|
72452672|NCT02307682|144427694|OTHER||Difference in proportions|-0.5|||||TWO_SIDED|95.0|-7.2|5.5||Hypothesis testing not pre-specified.|Regression, Logistic|||Week 64||5.5|-7.2|
72562226|NCT00407745|144655827|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.79|STANDARD_ERROR_OF_MEAN|0.22||0.0004|TWO_SIDED|95.0|-1.23|-0.35||Significance was declared if p-value \<=0.05|Mixed Models Analysis|||"Week 1.~A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used.~Effects for treatment, pooled center, time (week), baseline score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric."||-0.35|-1.23|0.0004
72562227|NCT00407745|144655827|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.87|STANDARD_ERROR_OF_MEAN|0.22|<|0.0001|TWO_SIDED|95.0|-1.31|-0.43||Significance was declared if p-value \<=0.05|Mixed Models Analysis|||"Week2~A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used.~Effects for treatment, pooled center, time (week), baseline score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric."||-0.43|-1.31|<0.0001
72452673|NCT02307682|144427694|OTHER||Difference in proportions|-0.6|||||TWO_SIDED|95.0|-6.6|5.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 64||5.7|-6.6|
72452674|NCT02307682|144427694|OTHER||Difference in proportions|2.0|||||TWO_SIDED|95.0|-4.3|8.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 68||8.3|-4.3|
72452675|NCT02307682|144427694|OTHER||Difference in proportions|-0.1|||||TWO_SIDED|95.0|-6.3|6.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 68||6.1|-6.3|
72499338|NCT03093402|144529126|SUPERIORITY||Mean Difference (Final Values)|0.89||||0.653|TWO_SIDED|95.0|-3.1|4.88||This p-value is from the overall 3 degree of freedom test that simultaneously compares the mean difference in the change from baseline PROMIS Pain Interference T-Score at Day 85 for each of the 3 JBT-101 cohorts versus placebo.|Mixed Models Analysis||Estimated mean difference of Medium JBT-101 - Placebo in the mean change from baseline at Day 85. The estimated Day 85 change from baseline and 95% confidence interval for the Placebo group was -4.9 (-7.6, -2.1).|Each active JBT-101 cohort is compared to placebo.||4.88|-3.10|0.653
72499339|NCT03093402|144529126|SUPERIORITY||Mean Difference (Final Values)|-0.32||||0.653|TWO_SIDED|95.0|-4.31|3.67||This p-value is from the overall 3 degree of freedom test that simultaneously compares the mean difference in the change from baseline PROMIS Pain Interference T-Score at Day 85 for each of the 3 JBT-101 cohorts versus placebo.|Mixed Models Analysis||Estimated mean difference of Low JBT-101 - Placebo in the mean change from baseline at Day 85. The estimated Day 85 change from baseline and 95% confidence interval for the Placebo group was -4.9 (-7.6, -2.1).|Each active JBT-101 cohort is compared to placebo.||3.67|-4.31|0.653
72452676|NCT02307682|144427694|OTHER||Difference in proportions|-0.4|||||TWO_SIDED|95.0|-7.2|5.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 72||5.6|-7.2|
72452677|NCT02307682|144427694|OTHER||Difference in proportions|-2.1|||||TWO_SIDED|95.0|-8.5|4.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 72||4.3|-8.5|
72452678|NCT02307682|144427694|OTHER||Difference in proportions|4.0|||||TWO_SIDED|95.0|-2.4|10.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 76||10.2|-2.4|
72452679|NCT02307682|144427694|OTHER||Difference in proportions|1.2|||||TWO_SIDED|95.0|-5.1|7.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 76||7.8|-5.1|
72452680|NCT02307682|144427694|OTHER||Difference in proportions|3.9|||||TWO_SIDED|95.0|-2.5|9.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 80||9.6|-2.5|
72452681|NCT02307682|144427694|OTHER||Difference in proportions|2.4|||||TWO_SIDED|95.0|-3.5|9.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 80||9.0|-3.5|
72452682|NCT02307682|144427694|OTHER||Difference in proportions|3.3|||||TWO_SIDED|95.0|-3.0|9.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 84||9.0|-3.0|
72452683|NCT02307682|144427694|OTHER||Difference in proportions|0.2|||||TWO_SIDED|95.0|-5.8|6.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 84||6.4|-5.8|
72562228|NCT00407745|144655827|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.8|STANDARD_ERROR_OF_MEAN|0.22||0.0004|TWO_SIDED|95.0|-1.24|-0.36||Significance was declared if p-value \<=0.05|Mixed Models Analysis|||"Week 3.~A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used.~Effects for treatment, pooled center, time (week), baseline score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric."||-0.36|-1.24|0.0004
72452684|NCT02307682|144427694|OTHER||Difference in proportions|0.0|||||TWO_SIDED|95.0|-6.6|6.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 88||6.5|-6.6|
72452685|NCT02307682|144427694|OTHER||Difference in proportions|-0.1|||||TWO_SIDED|95.0|-6.0|6.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 88||6.1|-6.0|
72562229|NCT00407745|144655827|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.76|STANDARD_ERROR_OF_MEAN|0.23||0.0008|TWO_SIDED|95.0|-1.2|-0.32||Significance was declared if p-value \<=0.05|Mixed Models Analysis|||"Week 4.~A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used.~Effects for treatment, pooled center, time (week), baseline score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric."||-0.32|-1.20|0.0008
72562230|NCT00407745|144655827|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.94|STANDARD_ERROR_OF_MEAN|0.23|<|0.0001|TWO_SIDED|95.0|-1.38|-0.49||Significance was declared if p-value \<=0.05|Mixed Models Analysis|||"Week 5.~A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used.~Effects for treatment, pooled center, time (week), baseline score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric."||-0.49|-1.38|<0.0001
72562231|NCT00407745|144655827|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.93|STANDARD_ERROR_OF_MEAN|0.23|<|0.0001|TWO_SIDED|95.0|-1.37|-0.48||Significance was declared if p-value \<=0.05|Mixed Models Analysis|||"Week 6.~A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used.~Effects for treatment, pooled center, time (week), baseline score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric."||-0.48|-1.37|<0.0001
72620057|NCT02006836|144771130|SUPERIORITY_OR_OTHER||||||>|0.05|||||||t-test, 1 sided|||"H0：∆g after breakfast- ∆g before breakfast = 0 H1：∆g after breakfast- ∆g before breakfast \> 0 α=5%~* g of breasfast without pomelo=mean of 3 days of postprandial blood glucose after breakfast - mean of 3 days of blood glucose before this breakfast.~* g of breasfast with pomelo=mean of 3 days of postprandial blood glucose after breakfast - mean of 3 days of blood glucose before this breakfast."||||>0.05
72452686|NCT02307682|144427694|OTHER||Difference in proportions|3.8|||||TWO_SIDED|95.0|-2.8|9.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 92||9.5|-2.8|
72452687|NCT02307682|144427694|OTHER||Difference in proportions|1.8|||||TWO_SIDED|95.0|-4.3|8.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 92||8.0|-4.3|
72452688|NCT02307682|144427694|OTHER||Difference in proportions|1.7|||||TWO_SIDED|95.0|-4.7|7.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 96||7.8|-4.7|
72452689|NCT02307682|144427694|OTHER||Difference in proportions|2.3|||||TWO_SIDED|95.0|-3.8|9.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 96||9.0|-3.8|
72452690|NCT02307682|144427695|OTHER|Treatment difference|Least Squares Mean Difference|-7.9|STANDARD_ERROR_OF_MEAN|8.3|||TWO_SIDED|95.0|-24.2|8.4||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 4||8.4|-24.2|
72452691|NCT02307682|144427695|OTHER|Treatment difference|Least Squares Mean Difference|-16.5|STANDARD_ERROR_OF_MEAN|7.86|||TWO_SIDED|95.0|-31.9|-1.1||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 4||-1.1|-31.9|
72452692|NCT02307682|144427695|OTHER|Treatment difference|Least Squares Mean Difference|-13.7|STANDARD_ERROR_OF_MEAN|8.51|||TWO_SIDED|95.0|-30.4|3.0||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 8||3.0|-30.4|
72452693|NCT02307682|144427695|OTHER|Treatment difference|Least Squares Mean Difference|-19.0|STANDARD_ERROR_OF_MEAN|8.16|||TWO_SIDED|95.0|-35.0|-2.9||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 8||-2.9|-35.0|
72452694|NCT02307682|144427695|OTHER|Treatment difference|Least Squares Mean Difference|-19.7|STANDARD_ERROR_OF_MEAN|8.45|||TWO_SIDED|95.0|-36.3|-3.1||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 12||-3.1|-36.3|
72452695|NCT02307682|144427695|OTHER||Least Squares Mean Difference|-24.5|STANDARD_ERROR_OF_MEAN|8.24|||TWO_SIDED|95.0|-40.7|-8.3||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 12||-8.3|-40.7|
72452696|NCT02307682|144427695|SUPERIORITY||Least Squares Mean Difference|-19.9|STANDARD_ERROR_OF_MEAN|9.24||0.0159|TWO_SIDED|95.0|-38.0|-1.7||1-sided testing for superiority of brolucizumab 3 mg versus aflibercept 2 mg|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 16||-1.7|-38.0|0.0159
72452697|NCT02307682|144427695|SUPERIORITY||Least Squares Mean Difference|-27.8|STANDARD_ERROR_OF_MEAN|8.8||0.0008|TWO_SIDED|95.0|-45.1|-10.5||1-sided testing for superiority of brolucizumab 6 mg versus aflibercept 2 mg|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 16||-10.5|-45.1|0.0008
72452698|NCT02307682|144427695|OTHER|Treatment difference|Least Squares Mean Difference|5.2|STANDARD_ERROR_OF_MEAN|8.69|||TWO_SIDED|95.0|-11.8|22.3||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 20||22.3|-11.8|
72452699|NCT02307682|144427695|OTHER|Treatment difference|Least Squares Mean Difference|3.2|STANDARD_ERROR_OF_MEAN|8.8|||TWO_SIDED|95.0|-14.1|20.5||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 20||20.5|-14.1|
72452700|NCT02307682|144427695|OTHER|Treatment difference|Least Squares Mean Difference|-25.8|STANDARD_ERROR_OF_MEAN|9.44|||TWO_SIDED|95.0|-44.3|-7.2||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 24||-7.2|-44.3|
72452701|NCT02307682|144427695|OTHER|Treatment difference|Least Squares Mean Difference|-29.6|STANDARD_ERROR_OF_MEAN|9.13|||TWO_SIDED|95.0|-47.5|-11.6||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 24||-11.6|-47.5|
72452702|NCT02307682|144427695|OTHER|Treatment difference|Least Squares Mean Difference|-11.6|STANDARD_ERROR_OF_MEAN|8.96|||TWO_SIDED|95.0|-29.2|5.9||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 28||5.9|-29.2|
72562232|NCT00407745|144655827|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.91|STANDARD_ERROR_OF_MEAN|0.23|<|0.0001|TWO_SIDED|95.0|-1.35|-0.47||Significance was declared if p-value \<=0.05|Mixed Models Analysis|||"Week 7.~A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used.~Effects for treatment, pooled center, time (week), baseline score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric."||-0.47|-1.35|<0.0001
72452703|NCT02307682|144427695|OTHER|Treatment difference|Least Squares Mean Difference|-12.1|STANDARD_ERROR_OF_MEAN|8.98|||TWO_SIDED|95.0|-29.8|5.5||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 28||5.5|-29.8|
72452704|NCT02307682|144427695|OTHER|Treatment difference|Least Squares Mean Difference|-20.1|STANDARD_ERROR_OF_MEAN|9.91|||TWO_SIDED|95.0|-39.6|-0.7||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 32||-0.7|-39.6|
72452705|NCT02307682|144427695|OTHER|Treatment difference|Least Squares Mean Difference|-23.2|STANDARD_ERROR_OF_MEAN|9.64|||TWO_SIDED|95.0|-42.1|-4.2||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 32||-4.2|-42.1|
72452706|NCT02307682|144427695|OTHER|Treatment difference|Least Squares Mean Difference|-17.4|STANDARD_ERROR_OF_MEAN|9.24|||TWO_SIDED|95.0|-35.5|0.7||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 36||0.7|-35.5|
72452707|NCT02307682|144427695|OTHER|Treatment difference|Least Squares Mean Difference|-19.6|STANDARD_ERROR_OF_MEAN|9.14|||TWO_SIDED|95.0|-37.6|-1.7||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 36||-1.7|-37.6|
72452708|NCT02307682|144427695|OTHER|Treatment difference|Least Squares Mean Difference|-27.3|STANDARD_ERROR_OF_MEAN|9.83|||TWO_SIDED|95.0|-46.6|-8.0||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 40||-8.0|-46.6|
72452709|NCT02307682|144427695|OTHER|Treatment difference|Least Squares Mean Difference|-29.5|STANDARD_ERROR_OF_MEAN|9.5|||TWO_SIDED|95.0|-48.2|-10.9||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 40||-10.9|-48.2|
72452710|NCT02307682|144427695|OTHER|Treatment difference|Least Squares Mean Difference|-9.3|STANDARD_ERROR_OF_MEAN|9.27|||TWO_SIDED|95.0|-27.5|8.9||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 44||8.9|-27.5|
72452711|NCT02307682|144427695|OTHER|Treatment difference|Least Squares Mean Difference|-11.4|STANDARD_ERROR_OF_MEAN|9.64|||TWO_SIDED|95.0|-30.3|7.5||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 44||7.5|-30.3|
72452712|NCT02307682|144427695|SUPERIORITY||Least Squares Mean Difference|-23.9|STANDARD_ERROR_OF_MEAN|9.79||0.0075|TWO_SIDED|95.0|-43.1|-4.6||1-sided testing for superiority of brolucizumab 3 mg versus aflibercept 2 mg|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 48||-4.6|-43.1|0.0075
72452713|NCT02307682|144427695|SUPERIORITY||Least Squares Mean Difference|-29.0|STANDARD_ERROR_OF_MEAN|9.47||0.0012|TWO_SIDED|95.0|-47.6|-10.4||1-sided testing for superiority of brolucizumab 6 mg versus aflibercept 2 mg|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 48||-10.4|-47.6|0.0012
72452714|NCT02307682|144427695|OTHER|Treatment difference|Least Squares Mean Difference|-15.6|STANDARD_ERROR_OF_MEAN|9.17|||TWO_SIDED|95.0|-33.6|2.4||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 52||2.4|-33.6|
72452715|NCT02307682|144427695|OTHER|Treatment difference|Least Squares Mean Difference|-15.1|STANDARD_ERROR_OF_MEAN|9.35|||TWO_SIDED|95.0|-33.4|3.3||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 52||3.3|-33.4|
72452716|NCT02307682|144427695|OTHER|Treatment difference|Least Squares Mean Difference|-20.0|STANDARD_ERROR_OF_MEAN|9.62|||TWO_SIDED|95.0|-38.9|-1.1||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 56||-1.1|-38.9|
72452717|NCT02307682|144427695|OTHER||Least Squares Mean Difference|-20.0|STANDARD_ERROR_OF_MEAN|9.86|||TWO_SIDED|95.0|-39.4|-0.7||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 56||-0.7|-39.4|
72452718|NCT02307682|144427695|OTHER|Treatment difference|Least Squares Mean Difference|-18.8|STANDARD_ERROR_OF_MEAN|9.3|||TWO_SIDED|95.0|-37.0|-0.5||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 60||-0.5|-37.0|
72452719|NCT02307682|144427695|OTHER|Treatment difference|Least Squares Mean Difference|-12.7|STANDARD_ERROR_OF_MEAN|9.56|||TWO_SIDED|95.0|-31.4|6.1||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 60||6.1|-31.4|
72452720|NCT02307682|144427695|OTHER|Treatment difference|Least Squares Mean Difference|-27.2|STANDARD_ERROR_OF_MEAN|9.96|||TWO_SIDED|95.0|-46.7|-7.6||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 64||-7.6|-46.7|
72452721|NCT02307682|144427695|OTHER|Treatment difference|Least Squares Mean Difference|-22.5|STANDARD_ERROR_OF_MEAN|9.73|||TWO_SIDED|95.0|-41.6|-3.4||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 64||-3.4|-41.6|
72391654|NCT01447433|144290648|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.94|STANDARD_ERROR_OF_MEAN|3.18||0.768|TWO_SIDED|95.0|-5.52|7.41|||t-test, 2 sided|||Diastolic Blood Pressure||7.41|-5.52|0.768
72452722|NCT02307682|144427695|OTHER|Treatment difference|Least Squares Mean Difference|-14.9|STANDARD_ERROR_OF_MEAN|9.6|||TWO_SIDED|95.0|-33.8|3.9||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 68||3.9|-33.8|
72452723|NCT02307682|144427695|OTHER|Treatment difference|Least Squares Mean Difference|-13.2|STANDARD_ERROR_OF_MEAN|9.88|||TWO_SIDED|95.0|-32.6|6.2||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 68||6.2|-32.6|
72452724|NCT02307682|144427695|OTHER|Treatment difference|Least Squares Mean Difference|-29.9|STANDARD_ERROR_OF_MEAN|9.89|||TWO_SIDED|95.0|-49.3|-10.5||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 72||-10.5|-49.3|
72452725|NCT02307682|144427695|OTHER|Treatment difference|Least Squares Mean Difference|-26.4|STANDARD_ERROR_OF_MEAN|9.99|||TWO_SIDED|95.0|-46.0|-6.8||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 72||-6.8|-46.0|
72452726|NCT02307682|144427695|OTHER|Treatment difference|Least Squares Mean Difference|-19.3|STANDARD_ERROR_OF_MEAN|9.62|||TWO_SIDED|95.0|-38.2|-0.4||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 76||-0.4|-38.2|
72452727|NCT02307682|144427695|OTHER|Treatment difference|Least Squares Mean Difference|-15.7|STANDARD_ERROR_OF_MEAN|9.84|||TWO_SIDED|95.0|-35.0|3.7||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 76||3.7|-35.0|
72452728|NCT02307682|144427695|OTHER|Treatment difference|Least Squares Mean Difference|-24.8|STANDARD_ERROR_OF_MEAN|10.34|||TWO_SIDED|95.0|-45.0|-4.5||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 80||-4.5|-45.0|
72452729|NCT02307682|144427695|OTHER|Treatment difference|Least Squares Mean Difference|-23.7|STANDARD_ERROR_OF_MEAN|10.32|||TWO_SIDED|95.0|-43.9|-3.4||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 80||-3.4|-43.9|
72452730|NCT02307682|144427695|OTHER|Treatment difference|Least Squares Mean Difference|-19.5|STANDARD_ERROR_OF_MEAN|9.65|||TWO_SIDED|95.0|-38.4|-0.5||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 84||-0.5|-38.4|
72452731|NCT02307682|144427695|OTHER|Treatment difference|Least Squares Mean Difference|-11.8|STANDARD_ERROR_OF_MEAN|10.05|||TWO_SIDED|95.0|-31.5|8.0||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 84||8.0|-31.5|
72452732|NCT02307682|144427695|OTHER|Treatment difference|Least Squares Mean Difference|-27.3|STANDARD_ERROR_OF_MEAN|10.16|||TWO_SIDED|95.0|-47.3|-7.4||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 88||-7.4|-47.3|
72452733|NCT02307682|144427695|OTHER|Treatment difference|Least Squares Mean Difference|-24.2|STANDARD_ERROR_OF_MEAN|10.22|||TWO_SIDED|95.0|-44.3|-4.2||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 88||-4.2|-44.3|
72562233|NCT00407745|144655827|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.9|STANDARD_ERROR_OF_MEAN|0.23|<|0.0001|TWO_SIDED|95.0|-1.35|-0.46||Significance was declared if p-value \<=0.05|Mixed Models Analysis|||"Week 8.~A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used.~Effects for treatment, pooled center, time (week), baseline score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric."||-0.46|-1.35|<0.0001
72452734|NCT02307682|144427695|OTHER|Treatment difference|Least Squares Mean Difference|-15.1|STANDARD_ERROR_OF_MEAN|9.7|||TWO_SIDED|95.0|-34.2|3.9||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 92||3.9|-34.2|
72452735|NCT02307682|144427695|OTHER|Treatment difference|Least Squares Mean Difference|-12.5|STANDARD_ERROR_OF_MEAN|9.99|||TWO_SIDED|95.0|-32.1|7.1||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 92||7.1|-32.1|
72391655|NCT01447433|144290649|SUPERIORITY_OR_OTHER||Median Difference (Net)|-0.08|STANDARD_ERROR_OF_MEAN|0.14||0.565|TWO_SIDED|95.0|-0.36|0.2|||t-test, 2 sided|||TC||0.20|-0.36|0.565
72391656|NCT01447433|144290649|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.07|STANDARD_ERROR_OF_MEAN|0.15||0.636|TWO_SIDED|95.0|-0.24|0.39|||t-test, 2 sided|||TG||0.39|-0.24|0.636
72391657|NCT01447433|144290649|SUPERIORITY_OR_OTHER||Median Difference (Net)|-0.26|STANDARD_ERROR_OF_MEAN|0.16||0.112|TWO_SIDED|95.0|-0.58|0.06|||t-test, 2 sided|||HDL||0.06|-0.58|0.112
72452736|NCT02307682|144427695|OTHER|Treatment difference|Least Squares Mean Difference|-30.9|STANDARD_ERROR_OF_MEAN|10.0|||TWO_SIDED|95.0|-50.6|-11.3||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 96||-11.3|-50.6|
72452737|NCT02307682|144427695|OTHER|Treatment difference|Least Squares Mean Difference|-26.0|STANDARD_ERROR_OF_MEAN|10.28|||TWO_SIDED|95.0|-46.2|-5.9||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 96||-5.9|-46.2|
72452738|NCT02307682|144427696|SUPERIORITY||Least Squares Mean Difference|-19.5|STANDARD_ERROR_OF_MEAN|9.29||0.0183|TWO_SIDED|95.0|-37.7|-1.2||1-sided testing for superiority of brolucizumab 3 mg versus aflibercept 2 mg|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|||-1.2|-37.7|0.0183
72499340|NCT03093402|144529127|SUPERIORITY||Mean Difference (Final Values)|-1.13||||0.245|TWO_SIDED|95.0|-2.56|0.29||This p-value is from the overall 3 degree of freedom test that simultaneously compares the mean difference in the change from baseline PROMIS Pain Intensity at Day 85 for each of the 3 JBT-101 cohorts versus placebo.|Mixed Models Analysis||Estimated mean difference of High JBT-101 - Placebo in the mean change from baseline at Day 85. The estimated Day 85 change from baseline and 95% confidence interval for the Placebo group was -1.1 (-2.1, -0.1).|||0.29|-2.56|0.245
72499341|NCT03093402|144529127|SUPERIORITY||Mean Difference (Final Values)|-0.56||||0.245|TWO_SIDED|95.0|-1.93|0.8||This p-value is from the overall 3 degree of freedom test that simultaneously compares the mean difference in the change from baseline PROMIS Pain Intensity at Day 85 for each of the 3 JBT-101 cohorts versus placebo.|Mixed Models Analysis||Estimated mean difference of Medium JBT-101 - Placebo in the mean change from baseline at Day 85. The estimated Day 85 change from baseline and 95% confidence interval for the Placebo group was -1.1 (-2.1, -0.1).|||0.80|-1.93|0.245
72499342|NCT03093402|144529127|SUPERIORITY||Mean Difference (Final Values)|-1.28||||0.245|TWO_SIDED|95.0|-2.64|0.09||This p-value is from the overall 3 degree of freedom test that simultaneously compares the mean difference in the change from baseline PROMIS Pain Intensity at Day 85 for each of the 3 JBT-101 cohorts versus placebo.|Mixed Models Analysis||Estimated mean difference of Low JBT-101 - Placebo in the mean change from baseline at Day 85. The estimated Day 85 change from baseline and 95% confidence interval for the Placebo group was -1.1 (-2.1, -0.1).|||0.09|-2.64|0.245
72499343|NCT03093402|144529128|SUPERIORITY||Mean Difference (Final Values)|-0.45||||0.608|TWO_SIDED|95.0|-4.45|3.54||This p-value is from the overall 3 degree of freedom test that simultaneously compares the mean difference in the change from baseline PROMIS Cognitive Function T-Score at Day 85 for each of the 3 JBT-101 cohorts versus placebo.|Mixed Models Analysis||Estimated mean difference of High JBT-101 - Placebo in the change from baseline at Day 85. The estimated Day 85 change from baseline and 95% confidence interval for the Placebo group was 1.4 (-1.5, 4.4).|Each active JBT-101 cohort is compared to placebo.||3.54|-4.45|0.608
72620058|NCT02006836|144771131|SUPERIORITY_OR_OTHER||||||>|0.05|||||||t-test, 1 sided|||"H0：∆g after lunch - ∆g before lunch = 0 H1：∆g after lunch - ∆g before lunch \> 0 α=5%~* g of lunch without pomelo=mean of 3 days of postprandial blood glucose after lunch - mean of 3 days of blood glucose before this lunch.~* g of lunch with pomelo=mean of 3 days of postprandial blood glucose after lunch - mean of 3 days of blood glucose before this lunch."||||>0.05
72452739|NCT02307682|144427696|SUPERIORITY||Least Squares Mean Difference|-22.4|STANDARD_ERROR_OF_MEAN|9.19||0.0075|TWO_SIDED|95.0|-40.4|-4.4||1-sided testing for superiority of brolucizumab 6 mg versus aflibercept 2 mg|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|||-4.4|-40.4|0.0075
72452740|NCT02307682|144427697|OTHER|Treatment difference|Least Squares Mean Difference|-23.2|STANDARD_ERROR_OF_MEAN|9.76|||TWO_SIDED|95.0|-42.4|-4.1||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|||-4.1|-42.4|
72452741|NCT02307682|144427697|OTHER|Treatment difference|Least Squares Mean Difference|-18.6|STANDARD_ERROR_OF_MEAN|10.0|||TWO_SIDED|95.0|-38.3|1.0||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|||1.0|-38.3|
72499344|NCT03093402|144529128|SUPERIORITY||Mean Difference (Final Values)|1.6||||0.608|TWO_SIDED|95.0|-2.27|5.47||This p-value is from the overall 3 degree of freedom test that simultaneously compares the mean difference in the change from baseline PROMIS Cognitive Function T-Score at Day 85 for each of the 3 JBT-101 cohorts versus placebo.|Mixed Models Analysis||Estimated mean difference of Medium JBT-101 - Placebo in the mean change from baseline at Day 85. The estimated Day 85 change from baseline and 95% confidence interval for the Placebo group was 1.4 (-1.5, 4.4).|Each active JBT-101 cohort is compared to placebo.||5.47|-2.27|0.608
72499345|NCT03093402|144529128|SUPERIORITY||Mean Difference (Final Values)|1.6||||0.608|TWO_SIDED|95.0|-2.25|5.45||This p-value is from the overall 3 degree of freedom test that simultaneously compares the mean difference in the change from baseline PROMIS Cognitive Function T-Score at Day 85 for each of the 3 JBT-101 cohorts versus placebo.|Mixed Models Analysis||Estimated mean difference of Low JBT-101 - Placebo in the mean change from baseline at Day 85. The estimated Day 85 change from baseline and 95% confidence interval for the Placebo group was 1.4 (-1.5, 4.4).|Each active JBT-101 cohort is compared to placebo.||5.45|-2.25|0.608
72499346|NCT02886702|144529144|EQUIVALENCE|90% confidence interval on the difference between the proportions to be within \[-20%, +20%\].|Risk Difference (RD)|-4.5||||||90.0|-12.6|3.6||p-value not calculated|Yates' corrected confidence interval|||||3.6|-12.6|
72499347|NCT02886702|144529144|SUPERIORITY|Last Observation Carried Forward (LOCF) for missing efficacy values||||||0.352|||||||Cochran-Mantel-Haenszel|stratified by clinical site||||||0.3520
72499348|NCT02886702|144529145|SUPERIORITY|||||||0.8105|||||||Cochran-Mantel-Haenszel|stratified by clinical site||||||0.8105
72499349|NCT02886702|144529145|SUPERIORITY|||||||0.0613|||||||Cochran-Mantel-Haenszel|stratified by clinical site||||||0.0613
72499350|NCT02886702|144529146|SUPERIORITY|||||||1|||||||Cochran-Mantel-Haenszel|stratified by clinical site||||||1.0000
72452742|NCT02307682|144427698|OTHER|Treatment difference|Least Squares Mean Difference|-16.0|STANDARD_ERROR_OF_MEAN|8.5|||TWO_SIDED|95.0|-32.6|0.7||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 4 to Week 48||0.7|-32.6|
72452743|NCT02307682|144427698|OTHER|Treatment difference|Least Squares Mean Difference|-19.9|STANDARD_ERROR_OF_MEAN|8.45|||TWO_SIDED|95.0|-36.5|-3.3||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 4 to Week 48||-3.3|-36.5|
72452744|NCT02307682|144427698|OTHER|Treatment difference|Least Squares Mean Difference|-18.9|STANDARD_ERROR_OF_MEAN|8.87|||TWO_SIDED|95.0|-36.4|-1.5||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 4 to Week 96||-1.5|-36.4|
72452745|NCT02307682|144427698|OTHER|Treatment difference|Least Squares Mean Difference|-19.3|STANDARD_ERROR_OF_MEAN|8.93|||TWO_SIDED|95.0|-36.9|-1.8||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 4 to Week 96||-1.8|-36.9|
72452746|NCT02307682|144427699|OTHER|Treatment difference|Least Squares Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.23|||TWO_SIDED|95.0|-0.8|0.1||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline lesion size categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 12||0.1|-0.8|
72452747|NCT02307682|144427699|OTHER|Treatment difference|Least Squares Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.2|||TWO_SIDED|95.0|-1.0|-0.2||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline lesion size categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 12||-0.2|-1.0|
72452748|NCT02307682|144427699|OTHER|Treatment difference|Least Squares Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.24|||TWO_SIDED|95.0|-1.1|-0.2||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline lesion size categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 48||-0.2|-1.1|
72452749|NCT02307682|144427699|OTHER|Treatment difference|Least Squares Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.22|||TWO_SIDED|95.0|-0.9|0.0||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline lesion size categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 48||0.0|-0.9|
72452750|NCT02307682|144427699|OTHER|Treatment difference|Least Squares Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.26|||TWO_SIDED|95.0|-1.3|-0.3||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline lesion size categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 96||-0.3|-1.3|
72452751|NCT02307682|144427699|OTHER|Treatment difference|Least Squares Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.23|||TWO_SIDED|95.0|-1.1|-0.3||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline lesion size categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 96||-0.3|-1.1|
72452752|NCT02307682|144427700|OTHER|Treatment difference|Least Squares Mean Difference|7.1|STANDARD_ERROR_OF_MEAN|5.31|||TWO_SIDED|95.0|-3.3|17.5||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFTns categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 4||17.5|-3.3|
72452753|NCT02307682|144427700|OTHER|Treatment difference|Least Squares Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|5.37|||TWO_SIDED|95.0|-10.2|10.9||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFTns categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 4||10.9|-10.2|
72452754|NCT02307682|144427700|OTHER|Treatment difference|Least Squares Mean Difference|2.1|STANDARD_ERROR_OF_MEAN|5.35|||TWO_SIDED|95.0|-8.4|12.6||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFTns categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 8||12.6|-8.4|
72452755|NCT02307682|144427700|OTHER|Treatment difference|Least Squares Mean Difference|-1.6|STANDARD_ERROR_OF_MEAN|5.52|||TWO_SIDED|95.0|-12.5|9.2||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFTns categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 8||9.2|-12.5|
72452756|NCT02307682|144427700|OTHER|Treatment difference|Least Squares Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|5.38|||TWO_SIDED|95.0|-11.2|10.0||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFTns categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 12||10.0|-11.2|
72499351|NCT02886702|144529146|SUPERIORITY|||||||0.0712|||||||Cochran-Mantel-Haenszel|stratified by clinical site||||||0.0712
72499352|NCT03068715|144529242|SUPERIORITY|We assessed the superiority of active over sham.|||||<|0.001|||||||Mixed Models Analysis|||MADRS scores were assessed with generalized linear mixed models (GLMM) that used Satterthwaite approximation of degrees of freedom and robust estimation of coefficients to handle violations of model assumptions. Fixed effects of time, treatment group (sham vs. active) and their interaction were assessed.||||<0.001
72499353|NCT03068715|144529243|SUPERIORITY|We assessed the superiority of active over sham.|||||=|0.001|||||||Mixed Models Analysis|||HDRS-17 scores were assessed with generalized linear mixed models (GLMM) that used Satterthwaite approximation of degrees of freedom and robust estimation of coefficients to handle violations of model assumptions. Fixed effects of time, treatment group (sham vs. active) and their interaction were assessed.||||=0.001
72620059|NCT02006836|144771132|SUPERIORITY_OR_OTHER||||||>|0.05|||||||t-test, 1 sided|||"H0：∆g after dinner- ∆g before dinner = 0 H1：∆g after dinner- ∆g before dinner \> 0 α=5%~* g of dinner without pomelo=mean of 3 days of postprandial blood glucose after dinner - mean of 3 days of blood glucose before this dinner.~* g of dinner with pomelo=mean of 3 days of postprandial blood glucose after dinner - mean of 3 days of blood glucose before this dinner."||||>0.05
72620060|NCT02006836|144771133|SUPERIORITY_OR_OTHER||||||>|0.05|||||||t-test, 1 sided|||H0: AUC||||>0.05
72452757|NCT02307682|144427700|OTHER|Treatment difference|Least Squares Mean Difference|-3.0|STANDARD_ERROR_OF_MEAN|5.55|||TWO_SIDED|95.0|-13.9|7.9||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFTns categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 12||7.9|-13.9|
72452758|NCT02307682|144427700|OTHER|Treatment difference|Least Squares Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|5.73|||TWO_SIDED|95.0|-11.1|11.4||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFTns categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 16||11.4|-11.1|
72452759|NCT02307682|144427700|OTHER|Treatment difference|Least Squares Mean Difference|-4.8|STANDARD_ERROR_OF_MEAN|5.76|||TWO_SIDED|95.0|-16.1|6.5||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFTns categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 16||6.5|-16.1|
72452760|NCT02307682|144427700|OTHER|Treatment difference|Least Squares Mean Difference|9.3|STANDARD_ERROR_OF_MEAN|5.56|||TWO_SIDED|95.0|-1.6|20.3||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFTns categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 20||20.3|-1.6|
72452761|NCT02307682|144427700|OTHER|Treatment difference|Least Squares Mean Difference|7.6|STANDARD_ERROR_OF_MEAN|5.58|||TWO_SIDED|95.0|-3.4|18.5||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFTns categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 20||18.5|-3.4|
72452762|NCT02307682|144427700|OTHER|Treatment difference|Least Squares Mean Difference|-3.6|STANDARD_ERROR_OF_MEAN|5.68|||TWO_SIDED|95.0|-14.7|7.6||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFTns categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 24||7.6|-14.7|
72452763|NCT02307682|144427700|OTHER|Treatment difference|Least Squares Mean Difference|-6.3|STANDARD_ERROR_OF_MEAN|5.92|||TWO_SIDED|95.0|-17.9|5.3||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFTns categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 24||5.3|-17.9|
72452764|NCT02307682|144427700|OTHER|Treatment difference|Least Squares Mean Difference|2.1|STANDARD_ERROR_OF_MEAN|5.51|||TWO_SIDED|95.0|-8.8|12.9||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFTns categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 28||12.9|-8.8|
72452765|NCT02307682|144427700|OTHER|Treatment difference|Least Squares Mean Difference|2.6|STANDARD_ERROR_OF_MEAN|5.73|||TWO_SIDED|95.0|-8.7|13.8||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFTns categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 28||13.8|-8.7|
72452766|NCT02307682|144427700|OTHER|Treatment difference|Least Squares Mean Difference|2.9|STANDARD_ERROR_OF_MEAN|5.73|||TWO_SIDED|95.0|-8.4|14.1||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFTns categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 32||14.1|-8.4|
72452767|NCT02307682|144427700|OTHER|Treatment difference|Least Squares Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|5.92|||TWO_SIDED|95.0|-11.7|11.5||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFTns categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 32||11.5|-11.7|
72452768|NCT02307682|144427700|OTHER|Treatment difference|Least Squares Mean Difference|2.4|STANDARD_ERROR_OF_MEAN|5.7|||TWO_SIDED|95.0|-8.8|13.6||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFTns categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 36||13.6|-8.8|
72452769|NCT02307682|144427700|OTHER|Treatment difference|Least Squares Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|5.89|||TWO_SIDED|95.0|-12.2|10.9||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFTns categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 36||10.9|-12.2|
72452770|NCT02307682|144427700|OTHER|Treatment difference|Least Squares Mean Difference|0.5|STANDARD_ERROR_OF_MEAN|5.71|||TWO_SIDED|95.0|-10.7|11.7||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFTns categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 40||11.7|-10.7|
72452771|NCT02307682|144427700|OTHER|Treatment difference|Least Squares Mean Difference|-3.6|STANDARD_ERROR_OF_MEAN|5.83|||TWO_SIDED|95.0|-15.0|7.8||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFTns categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 40||7.8|-15.0|
72452772|NCT02307682|144427700|OTHER|Treatment difference|Least Squares Mean Difference|4.9|STANDARD_ERROR_OF_MEAN|5.62|||TWO_SIDED|95.0|-6.1|15.9||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFTns categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 44||15.9|-6.1|
72452773|NCT02307682|144427700|OTHER|Treatment difference|Least Squares Mean Difference|1.5|STANDARD_ERROR_OF_MEAN|5.87|||TWO_SIDED|95.0|-10.0|13.1||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFTns categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 44||13.1|-10.0|
72452774|NCT02307682|144427700|OTHER|Treatment difference|Least Squares Mean Difference|0.8|STANDARD_ERROR_OF_MEAN|5.76|||TWO_SIDED|95.0|-10.5|12.1||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFTns categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 48||12.1|-10.5|
72452775|NCT02307682|144427700|OTHER|Treatment difference|Least Squares Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|5.93|||TWO_SIDED|95.0|-12.2|11.1||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFTns categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 48||11.1|-12.2|
72452776|NCT02307682|144427700|OTHER|Treatment difference|Least Squares Mean Difference|1.9|STANDARD_ERROR_OF_MEAN|5.77|||TWO_SIDED|95.0|-9.5|13.2||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFTns categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 52||13.2|-9.5|
72452777|NCT02307682|144427700|OTHER|Treatment difference|Least Squares Mean Difference|1.2|STANDARD_ERROR_OF_MEAN|6.04|||TWO_SIDED|95.0|-10.6|13.1||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFTns categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 52||13.1|-10.6|
72452778|NCT02307682|144427700|OTHER|Treatment difference|Least Squares Mean Difference|0.9|STANDARD_ERROR_OF_MEAN|5.87|||TWO_SIDED|95.0|-10.6|12.4||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFTns categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 56||12.4|-10.6|
72452779|NCT02307682|144427700|OTHER|Treatment difference|Least Squares Mean Difference|1.6|STANDARD_ERROR_OF_MEAN|6.08|||TWO_SIDED|95.0|-10.4|13.5||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFTns categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 56||13.5|-10.4|
72452780|NCT02307682|144427700|OTHER|Treatment difference|Least Squares Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|5.89|||TWO_SIDED|95.0|-11.9|11.2||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFTns categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 60||11.2|-11.9|
72452781|NCT02307682|144427700|OTHER|Treatment difference|Least Squares Mean Difference|2.4|STANDARD_ERROR_OF_MEAN|6.17|||TWO_SIDED|95.0|-9.7|14.6||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFTns categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 60||14.6|-9.7|
72452782|NCT02307682|144427700|OTHER|Treatment difference|Least Squares Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|5.87|||TWO_SIDED|95.0|-11.7|11.3||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFTns categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 64||11.3|-11.7|
72452783|NCT02307682|144427700|OTHER|Treatment difference|Least Squares Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|6.09|||TWO_SIDED|95.0|-12.2|11.7||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFTns categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 64||11.7|-12.2|
72452784|NCT02307682|144427700|OTHER|Treatment difference|Least Squares Mean Difference|2.3|STANDARD_ERROR_OF_MEAN|5.91|||TWO_SIDED|95.0|-9.3|13.9||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFTns categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 68||13.9|-9.3|
72452785|NCT02307682|144427700|OTHER|Treatment difference|Least Squares Mean Difference|2.1|STANDARD_ERROR_OF_MEAN|6.08|||TWO_SIDED|95.0|-9.8|14.0||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFTns categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 68||14.0|-9.8|
72452786|NCT02307682|144427700|OTHER|Treatment difference|Least Squares Mean Difference|-2.9|STANDARD_ERROR_OF_MEAN|5.91|||TWO_SIDED|95.0|-14.5|8.7||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFTns categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 72||8.7|-14.5|
72452787|NCT02307682|144427700|OTHER|Treatment difference|Least Squares Mean Difference|-1.8|STANDARD_ERROR_OF_MEAN|6.06|||TWO_SIDED|95.0|-13.7|10.1||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFTns categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 72||10.1|-13.7|
72452788|NCT02307682|144427700|OTHER|Treatment difference|Least Squares Mean Difference|1.8|STANDARD_ERROR_OF_MEAN|6.05|||TWO_SIDED|95.0|-10.0|13.7||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFTns categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 76||13.7|-10.0|
72452789|NCT02307682|144427700|OTHER|Treatment difference|Least Squares Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|6.13|||TWO_SIDED|95.0|-12.2|11.8||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFTns categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 76||11.8|-12.2|
72452790|NCT02307682|144427700|OTHER|Treatment difference|Least Squares Mean Difference|2.8|STANDARD_ERROR_OF_MEAN|6.05|||TWO_SIDED|95.0|-9.1|14.7||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFTns categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 80||14.7|-9.1|
72452791|NCT02307682|144427700|OTHER|Treatment difference|Least Squares Mean Difference|0.5|STANDARD_ERROR_OF_MEAN|6.01|||TWO_SIDED|95.0|-11.3|12.3||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFTns categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 80||12.3|-11.3|
72452792|NCT02307682|144427700|OTHER|Treatment difference|Least Squares Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|5.95|||TWO_SIDED|95.0|-11.9|11.5||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFTns categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 84||11.5|-11.9|
72452793|NCT02307682|144427700|OTHER|Treatment difference|Least Squares Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|6.04|||TWO_SIDED|95.0|-12.0|11.7||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFTns categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 84||11.7|-12.0|
72452794|NCT02307682|144427700|OTHER|Treatment difference|Least Squares Mean Difference|-1.7|STANDARD_ERROR_OF_MEAN|5.86|||TWO_SIDED|95.0|-13.2|9.8||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFTns categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 88||9.8|-13.2|
72452795|NCT02307682|144427700|OTHER|Treatment difference|Least Squares Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|6.0|||TWO_SIDED|95.0|-12.6|11.0||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFTns categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 88||11.0|-12.6|
72452796|NCT02307682|144427700|OTHER|Treatment difference|Least Squares Mean Difference|1.7|STANDARD_ERROR_OF_MEAN|5.87|||TWO_SIDED|95.0|-9.8|13.3||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFTns categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 92||13.3|-9.8|
72452797|NCT02307682|144427700|OTHER|Treatment difference|Least Squares Mean Difference|0.9|STANDARD_ERROR_OF_MEAN|6.09|||TWO_SIDED|95.0|-11.1|12.8||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFTns categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 92||12.8|-11.1|
72452798|NCT02307682|144427700|OTHER|Treatment difference|Least Squares Mean Difference|-4.0|STANDARD_ERROR_OF_MEAN|5.91|||TWO_SIDED|95.0|-15.6|7.6||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFTns categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 96||7.6|-15.6|
72452799|NCT02307682|144427700|OTHER|Treatment difference|Least Squares Mean Difference|-3.9|STANDARD_ERROR_OF_MEAN|6.07|||TWO_SIDED|95.0|-15.8|8.0||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFTns categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 96||8.0|-15.8|
72452800|NCT02307682|144427701|OTHER||Difference in proportions|-9.4|||||TWO_SIDED|95.0|-16.4|-3.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 4||-3.3|-16.4|
72452801|NCT02307682|144427701|OTHER||Difference in proportions|-14.2|||||TWO_SIDED|95.0|-21.3|-7.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 4||-7.3|-21.3|
72452802|NCT02307682|144427701|OTHER||Difference in proportions|-8.4|||||TWO_SIDED|95.0|-14.6|-2.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 8||-2.2|-14.6|
72452803|NCT02307682|144427701|OTHER||Difference in proportions|-15.0|||||TWO_SIDED|95.0|-20.9|-9.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 8||-9.5|-20.9|
72452804|NCT02307682|144427701|OTHER||Difference in proportions|-8.1|||||TWO_SIDED|95.0|-13.8|-2.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 12||-2.4|-13.8|
72452805|NCT02307682|144427701|OTHER||Difference in proportions|-14.0|||||TWO_SIDED|95.0|-18.9|-8.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 12||-8.7|-18.9|
72452806|NCT02307682|144427701|OTHER||Difference in proportions|-10.4|||||TWO_SIDED|95.0|-16.8|-3.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 16||-3.7|-16.8|
72452807|NCT02307682|144427701|OTHER||Difference in proportions|-19.7|||||TWO_SIDED|95.0|-25.8|-13.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 16||-13.4|-25.8|
72499354|NCT03068715|144529246|SUPERIORITY|We assessed the superiority of active over sham.|||||=|0.001|||||||Mixed Models Analysis|||HDRS-17 scores were assessed with generalized linear mixed models (GLMM) that used Satterthwaite approximation of degrees of freedom and robust estimation of coefficients to handle violations of model assumptions. Fixed effects of time, treatment group (sham vs. active) and their interaction were assessed.||||=0.001
72562234|NCT00407745|144655827|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.94|STANDARD_ERROR_OF_MEAN|0.23|<|0.0001|TWO_SIDED|95.0|-1.39|-0.5||Significance was declared if p-value \<=0.05|Mixed Models Analysis|||"Week 9.~A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used.~Effects for treatment, pooled center, time (week), baseline score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric."||-0.50|-1.39|<0.0001
72620061|NCT02722330|144771146|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Signed Rank test|||||||<0.0001
72620062|NCT02722330|144771147|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Signed Rank test|||Ease of communication||||<0.0001
72620063|NCT02722330|144771147|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Signed rank Test|||Reverberation||||<0.0001
72499355|NCT03068715|144529247|SUPERIORITY|"FC was calculated as the correlation (Pearson) of the activity pattern across time between ROIs. All Pearson correlation coefficients were then transformed into Fisher's Z score for further analysis.~sgACC (BA25) was defined by Brodmann areas (BA). The 4 nodes of DMN were extracted from the Multi-Subject Dictionary Learning (MSDL) atlas."|||||=|0.308|||||||t-test, 2 sided|Paired-t test was used for the statistics.||Functional connectivity between lsgACC\_lDMN in participants receiving active iTBS.||||=0.308
72620064|NCT02722330|144771147|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Signed rank Test|||Background noise||||<0.0001
72452808|NCT02307682|144427701|OTHER||Difference in proportions|4.1|||||TWO_SIDED|95.0|-2.0|9.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 20||9.9|-2.0|
72452809|NCT02307682|144427701|OTHER||Difference in proportions|2.1|||||TWO_SIDED|95.0|-4.3|7.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 20||7.9|-4.3|
72452810|NCT02307682|144427701|OTHER||Difference in proportions|-12.7|||||TWO_SIDED|95.0|-19.1|-6.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 24||-6.0|-19.1|
72452811|NCT02307682|144427701|OTHER||Difference in proportions|-23.4|||||TWO_SIDED|95.0|-29.7|-17.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 24||-17.6|-29.7|
72452812|NCT02307682|144427701|OTHER||Difference in proportions|-2.8|||||TWO_SIDED|95.0|-8.7|3.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 28||3.4|-8.7|
72452813|NCT02307682|144427701|OTHER||Difference in proportions|-5.1|||||TWO_SIDED|95.0|-11.2|0.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 28||0.4|-11.2|
72452814|NCT02307682|144427701|OTHER||Difference in proportions|-7.7|||||TWO_SIDED|95.0|-14.3|-1.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 32||-1.0|-14.3|
72452815|NCT02307682|144427701|OTHER||Difference in proportions|-12.4|||||TWO_SIDED|95.0|-19.3|-6.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 32||-6.2|-19.3|
72499356|NCT03068715|144529247|SUPERIORITY|FC was calculated as the correlation (Pearson) of the activity pattern across time between ROIs. All Pearson correlation coefficients were then transformed into Fisher's Z score for further analysis. sgACC (BA25) was defined by Brodmann areas (BA). The 4 nodes of DMN were extracted from the Multi-Subject Dictionary Learning (MSDL) atlas.|||||=|0.778|||||||t-test, 2 sided|Paired t-test was used for the statistics.||Functional connectivity between lsgACC\_lDMN in participants receiving sham iTBS.||||=0.778
72499357|NCT03068715|144529247|SUPERIORITY|"FC was calculated as the correlation (Pearson) of the activity pattern across time between ROIs. All Pearson correlation coefficients were then transformed into Fisher's Z score for further analysis.~sgACC (BA25) was defined by Brodmann areas (BA). The 4 nodes of DMN were extracted from the Multi-Subject Dictionary Learning (MSDL) atlas."|||||=|0.468|||||||t-test, 2 sided|Paired t-test was used for the statistics.||Functional connectivity between lDMN\_rDMN in participants receiving active iTBS.||||=0.468
72620065|NCT02722330|144771147|SUPERIORITY_OR_OTHER|||||||0.0004|||||||Wilcoxon Signed rank Test|||Aversiveness||||0.0004
72452816|NCT02307682|144427701|OTHER||Difference in proportions|-7.8|||||TWO_SIDED|95.0|-13.2|-2.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 36||-2.2|-13.2|
72452817|NCT02307682|144427701|OTHER||Difference in proportions|-10.3|||||TWO_SIDED|95.0|-15.9|-4.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 36||-4.9|-15.9|
72452818|NCT02307682|144427701|OTHER||Difference in proportions|-5.6|||||TWO_SIDED|95.0|-11.5|0.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 40||0.9|-11.5|
72452819|NCT02307682|144427701|OTHER||Difference in proportions|-11.4|||||TWO_SIDED|95.0|-17.7|-5.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 40||-5.6|-17.7|
72499358|NCT03068715|144529247|SUPERIORITY|FC was calculated as the correlation (Pearson) of the activity pattern across time between ROIs. All Pearson correlation coefficients were then transformed into Fisher's Z score for further analysis. sgACC (BA25) was defined by Brodmann areas (BA). The 4 nodes of DMN were extracted from the Multi-Subject Dictionary Learning (MSDL) atlas.|||||=|0.486|||||||t-test, 2 sided|Paired t-test was used for the statistics.||Functional connectivity between lDMN\_rDMN in participants receiving sham iTBS.||||=0.486
72499359|NCT03068715|144529248|SUPERIORITY|"FC was calculated as the correlation (Pearson) of the activity pattern across time between ROIs. All Pearson correlation coefficients were then transformed into Fisher's Z score for further analysis.~sgACC (BA25) was defined by Brodmann areas (BA). The 4 nodes of DMN were extracted from the Multi-Subject Dictionary Learning (MSDL) atlas."|||||=|0.447|||||||t-test, 2 sided|Paired t-test was used for the statistics.||Functional connectivity between lsgACC\_lDMN in participants receiving active iTBS.||||=0.447
72620066|NCT02722330|144771147|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Signed rank Test|||Global score||||<0.0001
72452820|NCT02307682|144427701|OTHER||Difference in proportions|0.9|||||TWO_SIDED|95.0|-5.1|6.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 44||6.7|-5.1|
72452821|NCT02307682|144427701|OTHER||Difference in proportions|-3.1|||||TWO_SIDED|95.0|-8.7|2.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 44||2.4|-8.7|
72452822|NCT02307682|144427701|OTHER||Difference in proportions|-11.6|||||TWO_SIDED|95.0|-17.8|-5.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 48||-5.5|-17.8|
72452823|NCT02307682|144427701|OTHER||Difference in proportions|-15.6|||||TWO_SIDED|95.0|-21.2|-9.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 48||-9.7|-21.2|
72452824|NCT02307682|144427701|OTHER||Difference in proportions|-2.6|||||TWO_SIDED|95.0|-8.0|3.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 52||3.0|-8.0|
72452825|NCT02307682|144427701|OTHER||Difference in proportions|-8.6|||||TWO_SIDED|95.0|-13.7|-3.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 52||-3.4|-13.7|
72452826|NCT02307682|144427701|OTHER||Difference in proportions|-6.9|||||TWO_SIDED|95.0|-12.6|-0.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 56||-0.7|-12.6|
72452827|NCT02307682|144427701|OTHER||Difference in proportions|-9.6|||||TWO_SIDED|95.0|-16.0|-3.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 56||-3.8|-16.0|
72452828|NCT02307682|144427701|OTHER||Difference in proportions|-4.5|||||TWO_SIDED|95.0|-9.9|0.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 60||0.7|-9.9|
72452829|NCT02307682|144427701|OTHER||Difference in proportions|-8.5|||||TWO_SIDED|95.0|-13.9|-3.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 60||-3.4|-13.9|
72452830|NCT02307682|144427701|OTHER||Difference in proportions|-7.4|||||TWO_SIDED|95.0|-13.1|-1.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 64||-1.2|-13.1|
72620067|NCT02722330|144771148|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Signed Rank test|||Speech scale||||<0.0001
72620068|NCT02722330|144771148|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Signed Rank test|||Spatial scale||||<0.0001
72452831|NCT02307682|144427701|OTHER||Difference in proportions|-12.0|||||TWO_SIDED|95.0|-17.8|-6.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 64||-6.0|-17.8|
72452832|NCT02307682|144427701|OTHER||Difference in proportions|2.7|||||TWO_SIDED|95.0|-2.5|8.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 68||8.4|-2.5|
72452833|NCT02307682|144427701|OTHER||Difference in proportions|-1.4|||||TWO_SIDED|95.0|-6.7|3.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 68||3.7|-6.7|
72452834|NCT02307682|144427701|OTHER||Difference in proportions|-7.5|||||TWO_SIDED|95.0|-12.8|-1.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 72||-1.6|-12.8|
72620069|NCT02722330|144771148|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Signed Rank test|||Qualities scale||||<0.0001
72620070|NCT02722330|144771149|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Signed Rank test|||||||<0.0001
72620071|NCT02722330|144771150|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Signed Rank test|||250 Hz||||<0.0001
72620072|NCT02722330|144771150|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Signed Rank test|||500 Hz||||<0.0001
72620073|NCT02722330|144771150|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Signed Rank test|||750 Hz||||<0.0001
72499360|NCT03068715|144529248|SUPERIORITY|"FC was calculated as the correlation (Pearson) of the activity pattern across time between ROIs. All Pearson correlation coefficients were then transformed into Fisher's Z score for further analysis.~sgACC (BA25) was defined by Brodmann areas (BA). The 4 nodes of DMN were extracted from the Multi-Subject Dictionary Learning (MSDL) atlas."|||||=|0.115|||||||t-test, 2 sided|Paired t-test was used for the statistics.||Functional connectivity between lsgACC\_lDMN in participants receiving sham iTBS.||||=0.115
72452835|NCT02307682|144427701|OTHER||Difference in proportions|-12.5|||||TWO_SIDED|95.0|-18.2|-7.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 72||-7.0|-18.2|
72452836|NCT02307682|144427701|OTHER||Difference in proportions|-1.4|||||TWO_SIDED|95.0|-7.0|4.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 76||4.5|-7.0|
72452837|NCT02307682|144427701|OTHER||Difference in proportions|-5.9|||||TWO_SIDED|95.0|-11.4|-0.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 76||-0.7|-11.4|
72452838|NCT02307682|144427701|OTHER||Difference in proportions|-6.1|||||TWO_SIDED|95.0|-11.8|-0.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 80||-0.1|-11.8|
72452839|NCT02307682|144427701|OTHER||Difference in proportions|-11.7|||||TWO_SIDED|95.0|-17.0|-6.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 80||-6.4|-17.0|
72452840|NCT02307682|144427701|OTHER||Difference in proportions|-5.1|||||TWO_SIDED|95.0|-10.1|0.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 84||0.1|-10.1|
72452841|NCT02307682|144427701|OTHER||Difference in proportions|-5.1|||||TWO_SIDED|95.0|-10.0|0.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 84||-0.0|-10.0|
72452842|NCT02307682|144427701|OTHER||Difference in proportions|-5.7|||||TWO_SIDED|95.0|-11.7|0.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 88||0.5|-11.7|
72499361|NCT03068715|144529248|SUPERIORITY|"FC was calculated as the correlation (Pearson) of the activity pattern across time between ROIs. All Pearson correlation coefficients were then transformed into Fisher's Z score for further analysis.~sgACC (BA25) was defined by Brodmann areas (BA). The 4 nodes of DMN were extracted from the Multi-Subject Dictionary Learning (MSDL) atlas."|||||=|0.546|||||||t-test, 2 sided|Paired t-test was used for the statistics.||Functional connectivity between lDMN\_rDMN in participants receiving active iTBS.||||=0.546
72562235|NCT00407745|144655827|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.08|STANDARD_ERROR_OF_MEAN|0.23|<|0.0001|TWO_SIDED|95.0|-1.53|-0.63||Significance was declared if p-value \<=0.05|Mixed Models Analysis|||"Week 10.~A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used.~Effects for treatment, pooled center, time (week), baseline score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric."||-0.63|-1.53|<0.0001
72620074|NCT02722330|144771150|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Signed Rank test|||1000 Hz||||<0.0001
72452843|NCT02307682|144427701|OTHER||Difference in proportions|-11.7|||||TWO_SIDED|95.0|-17.3|-6.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 88||-6.3|-17.3|
72452844|NCT02307682|144427701|OTHER||Difference in proportions|1.1|||||TWO_SIDED|95.0|-4.0|6.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 92||6.5|-4.0|
72452845|NCT02307682|144427701|OTHER||Difference in proportions|-5.0|||||TWO_SIDED|95.0|-9.7|-0.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 92||-0.3|-9.7|
72499362|NCT03068715|144529248|SUPERIORITY|"FC was calculated as the correlation (Pearson) of the activity pattern across time between ROIs. All Pearson correlation coefficients were then transformed into Fisher's Z score for further analysis.~sgACC (BA25) was defined by Brodmann areas (BA). The 4 nodes of DMN were extracted from the Multi-Subject Dictionary Learning (MSDL) atlas."|||||=|0.607|||||||t-test, 2 sided|||Functional connectivity between lDMN\_rDMN in participants receiving sham iTBS.||||=0.607
72499363|NCT03068715|144529249|SUPERIORITY||P value of the interaction|0.11|||<|0.05|TWO_SIDED|||||Not adjusted for multiple comparisons at this time.|Mixed Models Analysis|We were interested in the interaction between treatment condition and timepoint.||We conducted a linear mixed models analysis, with a focus on the interaction term. No power analysis for this measure because number of participants was determined by other primary study aims.||||<0.05
72452846|NCT02307682|144427701|OTHER||Difference in proportions|-5.5|||||TWO_SIDED|95.0|-11.4|-0.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 96||-0.1|-11.4|
72452847|NCT02307682|144427701|OTHER||Difference in proportions|-11.1|||||TWO_SIDED|95.0|-16.4|-6.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 96||-6.2|-16.4|
72452848|NCT02307682|144427702|OTHER||Difference in proportions|-2.0|||||TWO_SIDED|95.0|-7.9|3.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 4||3.6|-7.9|
72452849|NCT02307682|144427702|OTHER||Difference in proportions|1.7|||||TWO_SIDED|95.0|-4.1|7.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 4||7.4|-4.1|
72452850|NCT02307682|144427702|OTHER||Difference in proportions|-4.5|||||TWO_SIDED|95.0|-10.0|1.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 8||1.3|-10.0|
72452851|NCT02307682|144427702|OTHER||Difference in proportions|-1.5|||||TWO_SIDED|95.0|-7.7|4.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 8||4.5|-7.7|
72499364|NCT03068715|144529250|SUPERIORITY|The SDNN (the standard deviation of the RR intervals) was recorded using ECG. It was not necessary to conduct a power analysis for this measure because the number of participants in the study was based on other considerations (primary treatment goals of the study).|P value of the interaction|0.245|||<|0.05|TWO_SIDED|||||For reporting purposes here the p value was not adjusted for multiple comparisons.|Mixed Models Analysis|We were interested in the significance of the interaction between treatment group and timepoint.||We used a linear mixed models analysis, with the fixed factors being treatment group and timepoint.||||<0.05
72499365|NCT00885079|144529262|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for change from baseline in the FCS score was determined by comparing the non-inferiority margin (0.4) with the upper limit of the confidence interval of the difference between the 2 treatment groups.|Mean Difference (Final Values)|-0.9|STANDARD_DEVIATION|2.1|<|0.05|TWO_SIDED|95.0|-1.47|-0.24||An analysis of change from baseline of FCS was performed using t-test. The level of singnificanse was 5 % (2-sided).|t-test, 2 sided|||||-0.24|-1.47|<0.05
72499366|NCT00885079|144529263|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.1|||<|0.05|||||||t-test, 2 sided|||||||<0.05
72620075|NCT02722330|144771150|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Signed Rank test|||1500 Hz||||<0.0001
72452852|NCT02307682|144427702|OTHER||Difference in proportions|-2.7|||||TWO_SIDED|95.0|-7.6|2.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 12||2.3|-7.6|
72452853|NCT02307682|144427702|OTHER||Difference in proportions|0.3|||||TWO_SIDED|95.0|-5.4|5.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 12||5.8|-5.4|
72452854|NCT02307682|144427702|OTHER||Difference in proportions|-2.5|||||TWO_SIDED|95.0|-8.3|3.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 16||3.6|-8.3|
72499367|NCT02630953|144529267|SUPERIORITY||Median Difference (Final Values)|-6.22||||0.24|TWO_SIDED|95.0|-41.15|28.7||Significance level was set at .05 a priori.|quantile regression|Bootstrapped standard errors (10,000 replications)||Using a series of quantile regression models with bootstrapped standard errors (10,000 replications) we examined the potential treatment effects on MVPA at follow-ups, controlling for baseline. Quantile regression models the median outcome instead of the mean, and are appropriate when data is skewed (as was the case in both self-reported and objectively measured MVPA).||28.70|-41.15|0.24
72499368|NCT02630953|144529268|SUPERIORITY||Median Difference (Final Values)|7.5||||0.73|TWO_SIDED|95.0|-32.37|47.37||Significance was set at .05 a priori|quantile regression|||Using a series of quantile regression models with bootstrapped standard errors (10,000 replications) we examined the potential treatment effects on MVPA at follow-up, controlling for baseline||47.37|-32.37|0.73
72499369|NCT02630953|144529269|SUPERIORITY||Mean Difference (Net)|-0.06|STANDARD_ERROR_OF_MEAN|0.035|>|0.06|TWO_SIDED|||||Significance level set at .05 a priori|Regression, Linear|||Using a series of generalized linear models with identity link, we examined treatment effects on biomarkers at 6 months controlling for baseline and potential confounders.||||>.06
72499370|NCT01707992|144529313|SUPERIORITY||Hazard Ratio (HR)|0.937|||=|0.7057|TWO_SIDED|95.0|0.668|1.313||Threshold for significance at 0.05 level.|Cox proportional hazards model|||The primary analysis for the comparison between laquinimod 0.6 mg versus placebo was conducted using the baseline adjusted Cox proportional hazards model. Categorical EDSS at baseline (less than or equal to \[\<=\] 4 or greater than \[\>\] 4), country/geographical region (CGR), categorical age at baseline (\<=38 or \>38), and T2 volume at baseline were included as covariates in the model.||1.313|0.668|= 0.7057
72620076|NCT02722330|144771150|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Signed Rank test|||2000 Hz||||<0.0001
72620077|NCT02722330|144771150|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Signed Rank test|||3000 Hz||||<0.0001
72452855|NCT02307682|144427702|OTHER||Difference in proportions|-4.3|||||TWO_SIDED|95.0|-10.0|1.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 16||1.9|-10.0|
72452856|NCT02307682|144427702|OTHER||Difference in proportions|10.6|||||TWO_SIDED|95.0|5.0|16.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 20||16.2|5.0|
72452857|NCT02307682|144427702|OTHER||Difference in proportions|10.0|||||TWO_SIDED|95.0|4.7|15.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 20||15.4|4.7|
72452858|NCT02307682|144427702|OTHER||Difference in proportions|-4.0|||||TWO_SIDED|95.0|-9.8|1.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 24||1.7|-9.8|
72452859|NCT02307682|144427702|OTHER||Difference in proportions|-9.0|||||TWO_SIDED|95.0|-14.9|-3.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 24||-3.0|-14.9|
72452860|NCT02307682|144427702|OTHER||Difference in proportions|2.9|||||TWO_SIDED|95.0|-2.1|8.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 28||8.4|-2.1|
72562236|NCT00407745|144655827|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.94|STANDARD_ERROR_OF_MEAN|0.23|<|0.0001|TWO_SIDED|95.0|-1.39|-0.49||Significance was declared if p-value \<=0.05|Mixed Models Analysis|||"Week 11.~A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used.~Effects for treatment, pooled center, time (week), baseline score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric."||-0.49|-1.39|<0.0001
72562237|NCT00407745|144655827|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.92|STANDARD_ERROR_OF_MEAN|0.23|<|0.0001|TWO_SIDED|95.0|-1.37|-0.47||Significance was declared if p-value \<=0.05|Mixed Models Analysis|||"Week 12.~A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used.~Effects for treatment, pooled center, time (week), baseline score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric."||-0.47|-1.37|<0.0001
72562238|NCT00407745|144655827|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.92|STANDARD_ERROR_OF_MEAN|0.23|<|0.0001|TWO_SIDED|95.0|-1.38|-0.47||Significance was declared if p-value \<=0.05|Mixed Models Analysis|||"Week 13.~A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used.~Effects for treatment, pooled center, time (week), baseline score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric."||-0.47|-1.38|<0.0001
72562239|NCT00407745|144655827|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.96|STANDARD_ERROR_OF_MEAN|0.23|<|0.0001|TWO_SIDED|95.0|-1.41|-0.51||Significance was declared if p-value \<=0.05|Mixed Models Analysis|||"Week 14.~A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used.~Effects for treatment, pooled center, time (week), baseline score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric."||-0.51|-1.41|<0.0001
72562240|NCT00407745|144655827|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.08|STANDARD_ERROR_OF_MEAN|0.23|<|0.0001|TWO_SIDED|95.0|-1.53|-0.63||Significance was declared if p-value \<=0.05|Mixed Models Analysis|||"Week 15.~A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used.~Effects for treatment, pooled center, time (week), baseline score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric."||-0.63|-1.53|<0.0001
72620078|NCT02722330|144771150|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Signed Rank test|||4000 Hz||||<0.0001
72620079|NCT02722330|144771150|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Signed Rank test|||6000 Hz||||<0.0001
72620080|NCT02722330|144771151|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Signed Rank test|||250 Hz||||<0.0001
72620081|NCT02722330|144771151|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Signed Rank test|||500 Hz||||<0.0001
72620082|NCT02722330|144771151|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Signed Rank test|||750 Hz||||<0.0001
72620083|NCT02722330|144771151|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Signed Rank test|||1000 Hz||||<0.0001
72620084|NCT02722330|144771151|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Signed Rank test|||1500 Hz||||<0.0001
72452861|NCT02307682|144427702|OTHER||Difference in proportions|-0.8|||||TWO_SIDED|95.0|-6.3|5.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 28||5.1|-6.3|
72452862|NCT02307682|144427702|OTHER||Difference in proportions|0.0|||||TWO_SIDED|95.0|-5.8|6.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 32||6.1|-5.8|
72452863|NCT02307682|144427702|OTHER||Difference in proportions|-2.5|||||TWO_SIDED|95.0|-8.4|3.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 32||3.5|-8.4|
72452864|NCT02307682|144427702|OTHER||Difference in proportions|-1.0|||||TWO_SIDED|95.0|-6.4|4.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 36||4.4|-6.4|
72499371|NCT04551014|144529328|NON_INFERIORITY|For polypectomy without submucosal injection of EverLiftTM to be considered non-inferior, we calculated that 115 polyps were needed in each group to achieve an alpha value of 0.05, power of 90%, and non-inferiority margin of -10%.||||||0.424|||||||t-test, 2 sided|||||||0.424
72499372|NCT04551014|144529329|SUPERIORITY||||||<|0.0001||||||P-value of \<0.05 was considered statistically significant.|t-test, 2 sided|||||||<0.0001
72499373|NCT04551014|144529330|SUPERIORITY|||||||0.697||||||P-value of \<0.05 was considered statistically significant.|Chi-squared|||||||0.697
72499374|NCT00891202|144529352|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-30.03|STANDARD_ERROR_OF_MEAN|3.35|<|0.0001|TWO_SIDED|95.0|-36.82|-23.24|||ANCOVA|||Analysis was performed using analysis of covariance (ANCOVA) model fitted with treatment and baseline spleen severity (low spleen severity: spleen volume less than or equal to \[\<=\] 20 multiples of normal spleen volume, high spleen severity: spleen volume greater than \[\>\] 20 multiples of normal spleen volume).||-23.24|-36.82|<0.0001
72499375|NCT04108429|144529361|SUPERIORITY|||||||0.83|||||||Mixed Models Analysis|||generalized linear mixed model - this analysis accounts for repeated measures from each participant over the course of Weeks 1, 2, 4, 6 and 8||||.830
72562241|NCT00407745|144655827|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.06|STANDARD_ERROR_OF_MEAN|0.23|<|0.0001|TWO_SIDED|95.0|-1.51|-0.61||Significance was declared if p-value \<=0.05|Mixed Models Analysis|||"Week 16.~A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used.~Effects for treatment, pooled center, time (week), baseline score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric."||-0.61|-1.51|<0.0001
72620085|NCT02722330|144771151|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Signed Rank test|||2000 Hz||||<0.0001
72452865|NCT02307682|144427702|OTHER||Difference in proportions|-2.3|||||TWO_SIDED|95.0|-7.8|3.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 36||3.0|-7.8|
72452866|NCT02307682|144427702|OTHER||Difference in proportions|-3.8|||||TWO_SIDED|95.0|-9.6|1.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 40||1.7|-9.6|
72499376|NCT04108429|144529362|SUPERIORITY|||||||0.759|||||||Mixed Models Analysis|||generalized linear mixed model - this analysis accounts for repeated measures from each participant over the course of Weeks 1, 2, 4, 6 and 8||||.759
72499377|NCT04108429|144529363|SUPERIORITY|||||||0.275|||||||Simulation Modeling Analysis (SMA) for T|||Counseling center utilization data were examined using Simulation Modeling Analysis (SMA) for Time-Series data to determine if there were changes in utilization between the pre-implementation and implementation phases. SMA evaluates the statistical significance of between-phase changes in data streams and also accounts for the presence of autocorrelation (the non-independence of data points in time-series data streams).||||.275
72499378|NCT04108429|144529365|SUPERIORITY|generalized linear mixed model||||||0.002|||||||Mixed Models Analysis|||||||.002
72499379|NCT04108429|144529366|SUPERIORITY|||||||0.489|||||||Mixed Models Analysis|||generalized linear mixed model||||.489
72499380|NCT04108429|144529367|SUPERIORITY|||||||0.001|||||||Mixed Models Analysis|||generalized linear mixed model||||.001
72499381|NCT01587950|144529376|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.99||||0.8918|TWO_SIDED|95.0|-15.5|13.52|||ANCOVA|ANCOVA with factors for treatment group, application site, period and random effect for subject|Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|Null hypothesis suggested that mean change from baseline in the evaporative sensitivity within each of the treatment was zero immediately post treatment. Statistical tests were 2-sided with a significance level of 0.05.||13.52|-15.50|0.8918
72499382|NCT01587950|144529376|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-4.89||||0.5183|TWO_SIDED|95.0|-19.91|10.14|||ANCOVA|ANCOVA with factors for treatment group, application site, period and random effect for subject|Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.|Null hypothesis suggested that mean change from baseline in the evaporative sensitivity within each of the treatment was zero immediately post treatment. Statistical tests were 2-sided with a significance level of 0.05.||10.14|-19.91|0.5183
72499383|NCT01587950|144529376|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-3.89||||0.5718|TWO_SIDED|95.0|-17.59|9.8|||ANCOVA|ANCOVA with factors for treatment group, application site, period and random effect for subject.|Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|Null hypothesis suggested that mean change from baseline in the evaporative sensitivity within each of the treatment was zero immediately post treatment. Statistical tests were 2-sided with a significance level of 0.05.||9.80|-17.59|0.5718
72499384|NCT01587950|144529376|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|3.37||||0.6591|TWO_SIDED|95.0|-11.82|18.56|||ANCOVA|ANCOVA with factors for treatment group, application site, period and random effect for subject.|Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|Null hypothesis suggested that mean change from baseline in the evaporative sensitivity within each of the treatment was zero immediately post treatment. Statistical tests were 2-sided with a significance level of 0.05.||18.56|-11.82|0.6591
72620086|NCT02722330|144771151|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Signed Rank test|||3000 Hz||||<0.0001
72452867|NCT02307682|144427702|OTHER||Difference in proportions|-4.6|||||TWO_SIDED|95.0|-10.2|1.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 40||1.9|-10.2|
72452868|NCT02307682|144427702|OTHER||Difference in proportions|4.6|||||TWO_SIDED|95.0|-1.0|9.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 44||9.9|-1.0|
72452869|NCT02307682|144427702|OTHER||Difference in proportions|1.9|||||TWO_SIDED|95.0|-3.3|7.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 44||7.5|-3.3|
72452870|NCT02307682|144427702|OTHER||Difference in proportions|-0.6|||||TWO_SIDED|95.0|-6.2|5.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 48||5.1|-6.2|
72452871|NCT02307682|144427702|OTHER||Difference in proportions|-0.8|||||TWO_SIDED|95.0|-6.4|5.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 48||5.5|-6.4|
72452872|NCT02307682|144427702|OTHER||Difference in proportions|3.3|||||TWO_SIDED|95.0|-2.2|8.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 52||8.7|-2.2|
72499385|NCT01587950|144529376|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-3.02||||0.6921|TWO_SIDED|95.0|-18.17|12.13|||ANCOVA|ANCOVA with factors for treatment group, application site, period and random effect for subject.|Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|Null hypothesis suggested that mean change from baseline in the evaporative sensitivity within each of the treatment was zero immediately post treatment. Statistical tests were 2-sided with a significance level of 0.05.||12.13|-18.17|0.6921
72499386|NCT01587950|144529376|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-6.39||||0.3513|TWO_SIDED|95.0|-19.98|7.2|||ANCOVA|ANCOVA with factors for treatment group, application site, period and random effect for subject|Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|Null hypothesis suggested that mean change from baseline in the evaporative sensitivity within each of the treatment was zero immediately post treatment. Statistical tests were 2-sided with a significance level of 0.05.||7.20|-19.98|0.3513
72562242|NCT00407745|144655828|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.55|STANDARD_ERROR_OF_MEAN|0.269||0.0438|TWO_SIDED|95.0|-1.08|-0.02||Significance was declared if p-value \<=0.05|ANCOVA|ANCOVA model included terms of baseline mBPI-10 Total Score as a covariate and pooled center and treatment as fixed (class) cofactors.||Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group.||-0.02|-1.08|0.0438
72452873|NCT02307682|144427702|OTHER||Difference in proportions|1.9|||||TWO_SIDED|95.0|-3.2|7.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 52||7.4|-3.2|
72452874|NCT02307682|144427702|OTHER||Difference in proportions|2.3|||||TWO_SIDED|95.0|-3.5|8.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 56||8.1|-3.5|
72620087|NCT02722330|144771151|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Signed Rank test|||4000 Hz||||<0.0001
72620088|NCT02722330|144771151|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Signed Rank test|||6000 Hz||||<0.0001
72452875|NCT02307682|144427702|OTHER||Difference in proportions|-0.3|||||TWO_SIDED|95.0|-5.8|5.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 56||5.8|-5.8|
72452876|NCT02307682|144427702|OTHER||Difference in proportions|-1.5|||||TWO_SIDED|95.0|-6.6|3.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 60||3.8|-6.6|
72452877|NCT02307682|144427702|OTHER||Difference in proportions|-0.5|||||TWO_SIDED|95.0|-5.8|5.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 60||5.1|-5.8|
72499387|NCT01587950|144529376|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|8.96||||0.2346|TWO_SIDED|95.0|-5.96|23.88|||ANCOVA|ANCOVA with factors for treatment group, application site, period and random effect for subject|Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.|Null hypothesis suggested that mean change from baseline in the evaporative sensitivity within each of the treatment was zero immediately post treatment. Statistical tests were 2-sided with a significance level of 0.05.||23.88|-5.96|0.2346
72620089|NCT02722330|144771152|SUPERIORITY_OR_OTHER|||||||0.002|||||||Wilcoxon Signed Rank test|||||||0.002
72452878|NCT02307682|144427702|OTHER||Difference in proportions|-0.8|||||TWO_SIDED|95.0|-6.4|5.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 64||5.1|-6.4|
72452879|NCT02307682|144427702|OTHER||Difference in proportions|-3.0|||||TWO_SIDED|95.0|-8.7|2.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 64||2.6|-8.7|
72452880|NCT02307682|144427702|OTHER||Difference in proportions|5.5|||||TWO_SIDED|95.0|0.3|10.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 68||10.7|0.3|
72452881|NCT02307682|144427702|OTHER||Difference in proportions|2.2|||||TWO_SIDED|95.0|-3.2|7.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 68||7.2|-3.2|
72452882|NCT02307682|144427702|OTHER||Difference in proportions|-0.9|||||TWO_SIDED|95.0|-6.1|4.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 72||4.7|-6.1|
72452883|NCT02307682|144427702|OTHER||Difference in proportions|-3.4|||||TWO_SIDED|95.0|-9.0|1.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 72||1.9|-9.0|
72452884|NCT02307682|144427702|OTHER||Difference in proportions|3.1|||||TWO_SIDED|95.0|-1.9|8.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 76||8.1|-1.9|
72452885|NCT02307682|144427702|OTHER||Difference in proportions|1.3|||||TWO_SIDED|95.0|-3.9|6.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 76||6.4|-3.9|
72452886|NCT02307682|144427702|OTHER||Difference in proportions|0.7|||||TWO_SIDED|95.0|-4.7|6.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 80||6.6|-4.7|
72452887|NCT02307682|144427702|OTHER||Difference in proportions|0.2|||||TWO_SIDED|95.0|-5.2|6.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 80||6.1|-5.2|
72499388|NCT01587950|144529376|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|6.24||||0.4138|TWO_SIDED|95.0|-8.92|21.39|||ANCOVA|ANCOVA with factors for treatment group, application site, period and random effect for subject|Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.|Null hypothesis suggested that mean change from baseline in the evaporative sensitivity within each of the treatment was zero immediately post treatment. Statistical tests were 2-sided with a significance level of 0.05.||21.39|-8.92|0.4138
72620090|NCT02722330|144771153|SUPERIORITY_OR_OTHER|||||||0.0024|||||||Wilcoxon Signed Rank test|||||||0.0024
72452888|NCT02307682|144427702|OTHER||Difference in proportions|2.1|||||TWO_SIDED|95.0|-3.3|7.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 84||7.3|-3.3|
72452889|NCT02307682|144427702|OTHER||Difference in proportions|-0.3|||||TWO_SIDED|95.0|-5.7|4.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 84||4.8|-5.7|
72452890|NCT02307682|144427702|OTHER||Difference in proportions|3.9|||||TWO_SIDED|95.0|-1.7|9.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 88||9.7|-1.7|
72452891|NCT02307682|144427702|OTHER||Difference in proportions|0.1|||||TWO_SIDED|95.0|-5.3|5.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 88||5.6|-5.3|
72620091|NCT02722330|144771154|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Signed Rank test|||Speech Presentation Level 50 dB||||<0.0001
72620092|NCT02722330|144771154|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Signed Rank test|||Speech Presentation Level 65 dB||||<0.0001
72620093|NCT02722330|144771154|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Signed Rank test|||Speech Presentation Level 80 dB||||<0.0001
72620094|NCT02722330|144771155|SUPERIORITY_OR_OTHER||||||<|0.0001||||||All variable had the same p value (\<0.0001).|Wolcoxon Signed rank test|||Speech Presentation Level 50 dB||||<0.0001
72452892|NCT02307682|144427702|OTHER||Difference in proportions|3.8|||||TWO_SIDED|95.0|-1.3|8.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 92||8.9|-1.3|
72452893|NCT02307682|144427702|OTHER||Difference in proportions|0.9|||||TWO_SIDED|95.0|-4.3|6.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 92||6.0|-4.3|
72452894|NCT02307682|144427702|OTHER||Difference in proportions|-0.9|||||TWO_SIDED|95.0|-6.4|5.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 96||5.2|-6.4|
72452895|NCT02307682|144427702|OTHER||Difference in proportions|-4.9|||||TWO_SIDED|95.0|-10.8|0.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 96||0.9|-10.8|
72452896|NCT02307682|144427703|OTHER||Difference in proportions|-2.3|||||TWO_SIDED|95.0|-7.7|3.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 4||3.6|-7.7|
72452897|NCT02307682|144427703|OTHER||Difference in proportions|-5.7|||||TWO_SIDED|95.0|-11.4|0.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 4||0.4|-11.4|
72452898|NCT02307682|144427703|OTHER||Difference in proportions|-3.8|||||TWO_SIDED|95.0|-9.3|1.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 8||1.2|-9.3|
72562243|NCT00407745|144655829|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.17|STANDARD_ERROR_OF_MEAN|0.448||0.7103|TWO_SIDED|95.0|-1.06|0.72||Significance was declared if p-value \<=0.05|ANCOVA|ANCOVA model included terms of baseline QANeP - Static Mechanical Allodynia as a covariate and pooled center and treatment as fixed (class) cofactors.||"At/above level: within 2 dermatomes above or below the neurological level of injury (NLI).~Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group."||0.72|-1.06|0.7103
72452899|NCT02307682|144427703|OTHER||Difference in proportions|-4.4|||||TWO_SIDED|95.0|-9.8|1.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 8||1.2|-9.8|
72452900|NCT02307682|144427703|OTHER||Difference in proportions|-6.5|||||TWO_SIDED|95.0|-11.5|-1.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 12||-1.5|-11.5|
72620095|NCT02722330|144771155|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Signed Rank test|||Speech Presentation Level 65 dB||||<0.0001
72620096|NCT02722330|144771155|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Signed Rank test|||Speech Presentation Level 80 dB||||<0.0001
72452901|NCT02307682|144427703|OTHER||Difference in proportions|-7.6|||||TWO_SIDED|95.0|-12.8|-2.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 12||-2.3|-12.8|
72452902|NCT02307682|144427703|OTHER||Difference in proportions|-6.5|||||TWO_SIDED|95.0|-11.8|-1.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 16||-1.1|-11.8|
72452903|NCT02307682|144427703|OTHER||Difference in proportions|-8.6|||||TWO_SIDED|95.0|-14.4|-2.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 16||-2.9|-14.4|
72452904|NCT02307682|144427703|OTHER||Difference in proportions|2.7|||||TWO_SIDED|95.0|-2.8|8.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 20||8.3|-2.8|
72452905|NCT02307682|144427703|OTHER||Difference in proportions|2.1|||||TWO_SIDED|95.0|-3.4|7.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 20||7.5|-3.4|
72452906|NCT02307682|144427703|OTHER||Difference in proportions|-4.6|||||TWO_SIDED|95.0|-9.7|0.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 24||0.9|-9.7|
72620097|NCT02722330|144771156|SUPERIORITY_OR_OTHER|||||||0.036|||||||Wilcoxon Signed Rank test|||||||0.036
72620098|NCT02722330|144771157|SUPERIORITY_OR_OTHER|||||||0.065|||||||Wilcoxon Signed Rank test|||||||0.065
72620099|NCT02722330|144771158|SUPERIORITY_OR_OTHER|||||||0.47|||||||Wilcoxon Signed Rank test|||250 Hz||||0.47
72620100|NCT02722330|144771158|SUPERIORITY_OR_OTHER|||||||0.16|||||||Wilcoxon Signed Rank test|||500 Hz||||0.16
72452907|NCT02307682|144427703|OTHER||Difference in proportions|-7.1|||||TWO_SIDED|95.0|-12.3|-1.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 24||-1.3|-12.3|
72452908|NCT02307682|144427703|OTHER||Difference in proportions|1.1|||||TWO_SIDED|95.0|-4.2|6.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 28||6.2|-4.2|
72452909|NCT02307682|144427703|OTHER||Difference in proportions|-3.2|||||TWO_SIDED|95.0|-8.4|1.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 28||1.7|-8.4|
72562244|NCT00407745|144655829|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.61|STANDARD_ERROR_OF_MEAN|0.34||0.0747|TWO_SIDED|95.0|-1.28|0.06||Significance was declared if p-value \<=0.05|ANCOVA|ANCOVA model included terms of baseline QANeP - Static Mechanical Allodynia as a covariate and pooled center and treatment as fixed (class) cofactors.||"Below level: more than 2 dermatomes below the NLI.~Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group."||0.06|-1.28|0.0747
72620101|NCT02722330|144771158|SUPERIORITY_OR_OTHER|||||||0.59|||||||Wilcoxon Signed Rank test|||750 Hz||||0.59
72620102|NCT02722330|144771158|SUPERIORITY_OR_OTHER|||||||0.034|||||||Wilcoxon Signed Rank test|||1000 Hz||||0.034
72620103|NCT02722330|144771158|SUPERIORITY_OR_OTHER|||||||0.25|||||||Wilcoxon Signed Rank test|||1500 Hz||||0.25
72452910|NCT02307682|144427703|OTHER||Difference in proportions|-0.7|||||TWO_SIDED|95.0|-6.2|5.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 32||5.2|-6.2|
72562245|NCT00407745|144655830|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.22|STANDARD_ERROR_OF_MEAN|0.379||0.5689|TWO_SIDED|95.0|-0.97|0.54||Significance was declared if p-value \<=0.05|ANCOVA|ANCOVA model included terms of baseline QANeP - Dynamic Mechanical Allodynia as covariate and pooled center and treatment as fixed (class) cofactors.||"At/Above level~Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group."||0.54|-0.97|0.5689
72562246|NCT00407745|144655830|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.23|STANDARD_ERROR_OF_MEAN|0.322||0.4764|TWO_SIDED|95.0|-0.87|0.41||Significance was declared if p-value \<=0.05|ANCOVA|ANCOVA model included terms of baseline QANeP - Dynamic Mechanical Allodynia as covariate and pooled center and treatment as fixed (class) cofactors.||"Below level~Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group."||0.41|-0.87|0.4764
72562247|NCT00407745|144655831|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.46|STANDARD_ERROR_OF_MEAN|0.474||0.3362|TWO_SIDED|95.0|-1.4|0.48||Significance was declared if p-value \<=0.05|ANCOVA|ANCOVA model included terms of baseline QANeP - Punctate Hyperalgesia as a covariate and pooled center and treatment as fixed (class) cofactors.||"At/Above level~Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group."||0.48|-1.40|0.3362
72620104|NCT02722330|144771158|SUPERIORITY_OR_OTHER|||||||0.023|||||||Wilcoxon Signed Rank test|||2000 Hz||||0.023
72620105|NCT02722330|144771158|SUPERIORITY_OR_OTHER|||||||0.028|||||||Wilcoxon Signed Rank test|||3000 Hz||||0.028
72620106|NCT02722330|144771158|SUPERIORITY_OR_OTHER|||||||0.0075|||||||Wilcoxon Signed Rank test|||4000 Hz||||0.0075
72620107|NCT02722330|144771158|SUPERIORITY_OR_OTHER|||||||0.0035|||||||Wilcoxon Signed Rank test|||6000 Hz||||0.0035
72620108|NCT02722330|144771159|SUPERIORITY_OR_OTHER|||||||0.12|||||||Wilcoxon Signed Rank test|||250 Hz||||0.12
72620109|NCT02722330|144771159|SUPERIORITY_OR_OTHER|||||||0.072|||||||Wilcoxon Signed Rank test|||500 Hz||||0.072
72620110|NCT02722330|144771159|SUPERIORITY_OR_OTHER|||||||0.56|||||||Wilcoxon Signed Rank test|||750 Hz||||0.56
72452911|NCT02307682|144427703|OTHER||Difference in proportions|-2.4|||||TWO_SIDED|95.0|-7.5|3.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 32||3.4|-7.5|
72452912|NCT02307682|144427703|OTHER||Difference in proportions|-4.5|||||TWO_SIDED|95.0|-9.5|0.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 36||0.7|-9.5|
72620111|NCT02722330|144771159|SUPERIORITY_OR_OTHER|||||||0.16|||||||Wilcoxon Signed Rank test|||1000 Hz||||0.16
72620112|NCT02722330|144771159|SUPERIORITY_OR_OTHER|||||||0.39|||||||Wilcoxon Signed Rank test|||1500 Hz||||0.39
72620113|NCT02722330|144771159|SUPERIORITY_OR_OTHER|||||||0.11|||||||Wilcoxon Signed Rank test|||2000 Hz||||0.11
72620114|NCT02722330|144771159|SUPERIORITY_OR_OTHER|||||||0.38|||||||Wilcoxon Signed Rank test|||3000 Hz||||0.38
72620115|NCT02722330|144771159|SUPERIORITY_OR_OTHER|||||||0.014|||||||Wilcoxon Signed Rank test|||4000 Hz||||0.014
72452913|NCT02307682|144427703|OTHER||Difference in proportions|-5.4|||||TWO_SIDED|95.0|-10.6|-0.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 36||-0.6|-10.6|
72452914|NCT02307682|144427703|OTHER||Difference in proportions|-4.6|||||TWO_SIDED|95.0|-10.2|1.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 40||1.3|-10.2|
72452915|NCT02307682|144427703|OTHER||Difference in proportions|-6.3|||||TWO_SIDED|95.0|-12.2|-0.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 40||-0.8|-12.2|
72452916|NCT02307682|144427703|OTHER||Difference in proportions|-1.2|||||TWO_SIDED|95.0|-6.6|4.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 44||4.3|-6.6|
72499389|NCT01587950|144529376|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-2.72||||0.6931|TWO_SIDED|95.0|-16.44|10.99|||ANCOVA|ANCOVA with factors for treatment group, application site, period and random effect for subject|Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.|Null hypothesis suggested that mean change from baseline in the evaporative sensitivity within each of the treatment was zero immediately post treatment. Statistical tests were 2-sided with a significance level of 0.05.||10.99|-16.44|0.6931
72499390|NCT01587950|144529377|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-6.39||||0.3867|TWO_SIDED|95.0|-21.04|8.26|||ANCOVA|ANCOVA with factors for treatment group, application site, period and random effect for subject.|Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.|Null hypothesis suggested that mean change from baseline in the evaporative sensitivity within each of the treatment was zero, 10 minutes post treatment. Statistical tests were 2-sided with a significance level of 0.05.||8.26|-21.04|0.3867
72499391|NCT01587950|144529377|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-11.22||||0.1448|TWO_SIDED|95.0|-26.41|3.96|||ANCOVA|ANCOVA with factors for treatment group, application site, period and random effect for subject.|Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.|Null hypothesis suggested that mean change from baseline in the evaporative sensitivity within each of the treatment was zero, 10 minutes post treatment. Statistical tests were 2-sided with a significance level of 0.05.||3.96|-26.41|0.1448
72562248|NCT00407745|144655831|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.33|STANDARD_ERROR_OF_MEAN|0.321||0.3113|TWO_SIDED|95.0|-0.96|0.31||Significance was declared if p-value \<=0.05|ANCOVA|ANCOVA model included terms of baseline QANeP - Punctate Hyperalgesia as a covariate and pooled center and treatment as fixed (class) cofactors.||"Below level~Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group."||0.31|-0.96|0.3113
72562249|NCT00407745|144655832|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.539||0.2721|TWO_SIDED|95.0|-1.67|0.48||Significance was declared if p-value \<=0.05|ANCOVA|ANCOVA model included terms of baseline QANeP - Temporal Summation to stimuli as covariate and pooled center and treatment as fixed (class) cofactors.||"At/Above level~Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group."||0.48|-1.67|0.2721
72620116|NCT02722330|144771159|SUPERIORITY_OR_OTHER|||||||0.71|||||||Wilcoxon Signed Rank test|||6000 Hz||||0.71
72452917|NCT02307682|144427703|OTHER||Difference in proportions|-4.7|||||TWO_SIDED|95.0|-10.0|0.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 44||0.1|-10.0|
72452918|NCT02307682|144427703|OTHER||Difference in proportions|-4.0|||||TWO_SIDED|95.0|-9.4|1.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 48||1.4|-9.4|
72499392|NCT01587950|144529377|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-4.83||||0.4874|TWO_SIDED|95.0|-18.66|8.99|||ANCOVA|ANCOVA with factors for treatment group, application site, period and random effect for subject.|Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.|Null hypothesis suggested that mean change from baseline in the evaporative sensitivity within each of the treatment was zero, 10 minutes post treatment. Statistical tests were 2-sided with a significance level of 0.05.||8.99|-18.66|0.4874
72499393|NCT01587950|144529377|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-9.87||||0.2038|TWO_SIDED|95.0|-25.23|5.49|||ANCOVA|ANCOVA with factors for treatment group, application site, period and random effect for subject|Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.|Null hypothesis suggested that mean change from baseline in the evaporative sensitivity within the treatments was zero, 10 minutes post treatment. Statistical tests were 2-sided with a significance level of 0.05.||5.49|-25.23|0.2038
72620117|NCT02722330|144771160|SUPERIORITY_OR_OTHER|||||||0.48|||||||Wilcoxon Signed Rank test|||||||0.48
72620118|NCT02722330|144771161|SUPERIORITY_OR_OTHER|||||||0.11|||||||Wilcoxon Signed Rank test|||||||0.11
72620119|NCT02722330|144771162|SUPERIORITY_OR_OTHER|||||||0.017|||||||Wilcoxon Signed Rank test|||SPL 50 dB||||0.017
72620120|NCT02722330|144771162|SUPERIORITY_OR_OTHER|||||||0.095|||||||Wilcoxon Signed Rank test|||SPL 65 dB||||0.095
72620121|NCT02722330|144771162|SUPERIORITY_OR_OTHER|||||||0.57|||||||Wilcoxon Signed Rank test|||SPL 80 dB||||0.57
72452919|NCT02307682|144427703|OTHER||Difference in proportions|-8.1|||||TWO_SIDED|95.0|-13.6|-2.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 48||-2.7|-13.6|
72452920|NCT02307682|144427703|OTHER||Difference in proportions|-0.4|||||TWO_SIDED|95.0|-5.1|4.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 52||4.5|-5.1|
72452921|NCT02307682|144427703|OTHER||Difference in proportions|-1.6|||||TWO_SIDED|95.0|-6.2|2.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 52||2.8|-6.2|
72452922|NCT02307682|144427703|OTHER||Difference in proportions|-4.2|||||TWO_SIDED|95.0|-9.4|1.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 56||1.2|-9.4|
72499394|NCT01587950|144529377|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-11.12||||0.1518|TWO_SIDED|95.0|-26.43|4.19|||ANCOVA|ANCOVA with factors for treatment group, application site, period and random effect for subject|Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.|Null hypothesis suggested that mean change from baseline in the evaporative sensitivity within the treatments was zero, 10 minutes post treatment. Statistical tests were 2-sided with a significance level of 0.05.||4.19|-26.43|0.1518
72452923|NCT02307682|144427703|OTHER||Difference in proportions|-6.2|||||TWO_SIDED|95.0|-11.5|-0.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 56||-0.8|-11.5|
72452924|NCT02307682|144427703|OTHER||Difference in proportions|-2.3|||||TWO_SIDED|95.0|-7.3|3.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 60||3.0|-7.3|
72452925|NCT02307682|144427703|OTHER||Difference in proportions|-2.7|||||TWO_SIDED|95.0|-7.9|2.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 60||2.1|-7.9|
72499395|NCT01587950|144529377|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.25||||0.8567|TWO_SIDED|95.0|-14.98|12.49|||ANCOVA|ANCOVA with factors for treatment group, application site, period and random effect for subject.|Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.|Null hypothesis suggested that mean change from baseline in the evaporative sensitivity within the treatments was zero, 10 minutes post treatment. Statistical tests were 2-sided with a significance level of 0.05.||12.49|-14.98|0.8567
72562250|NCT00407745|144655832|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.23|STANDARD_ERROR_OF_MEAN|0.337||0.4906|TWO_SIDED|95.0|-0.43|0.9||Significance was declared if p-value \<=0.05|ANCOVA|ANCOVA model included terms of baseline QANeP - Temporal Summation to stimuli as covariate and pooled center and treatment as fixed (class) cofactors.||"Below level~Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group."||0.90|-0.43|0.4906
72562251|NCT00407745|144655833|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.48|STANDARD_ERROR_OF_MEAN|0.472||0.3123|TWO_SIDED|95.0|-1.42|0.46||Significance was declared if p-value \<=0.05|ANCOVA|ANCOVA model included terms of baseline QANeP - Cold Allodynia as a covariate and pooled center and treatment as fixed (class) cofactors.||"At/Above level~Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group."||0.46|-1.42|0.3123
72452926|NCT02307682|144427703|OTHER||Difference in proportions|-5.2|||||TWO_SIDED|95.0|-10.5|0.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 64||0.7|-10.5|
72452927|NCT02307682|144427703|OTHER||Difference in proportions|-7.1|||||TWO_SIDED|95.0|-12.5|-1.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 64||-1.8|-12.5|
72452928|NCT02307682|144427703|OTHER||Difference in proportions|-1.0|||||TWO_SIDED|95.0|-6.0|4.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 68||4.0|-6.0|
72499396|NCT01587950|144529377|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|11.01||||0.1493|TWO_SIDED|95.0|-4.06|26.08|||ANCOVA|ANCOVA with factors for treatment group, application site, period and random effect for subject.|Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.|Null hypothesis suggested that mean change from baseline in the evaporative sensitivity within the treatments was zero, at 10 minutes post treatment. Statistical tests were 2-sided with a significance level of 0.05.||26.08|-4.06|0.1493
72452929|NCT02307682|144427703|OTHER||Difference in proportions|-1.3|||||TWO_SIDED|95.0|-6.3|3.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 68||3.9|-6.3|
72452930|NCT02307682|144427703|OTHER||Difference in proportions|-5.4|||||TWO_SIDED|95.0|-10.1|-0.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 72||-0.4|-10.1|
72452931|NCT02307682|144427703|OTHER||Difference in proportions|-7.3|||||TWO_SIDED|95.0|-12.2|-2.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 72||-2.3|-12.2|
72452932|NCT02307682|144427703|OTHER||Difference in proportions|-0.8|||||TWO_SIDED|95.0|-5.2|4.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 76||4.3|-5.2|
72452933|NCT02307682|144427703|OTHER||Difference in proportions|-1.0|||||TWO_SIDED|95.0|-5.8|3.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 76||3.5|-5.8|
72452934|NCT02307682|144427703|OTHER||Difference in proportions|-3.4|||||TWO_SIDED|95.0|-8.4|1.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 80||1.8|-8.4|
72452935|NCT02307682|144427703|OTHER||Difference in proportions|-3.3|||||TWO_SIDED|95.0|-8.5|1.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 80||1.5|-8.5|
72452936|NCT02307682|144427703|OTHER||Difference in proportions|-4.7|||||TWO_SIDED|95.0|-9.8|0.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 84||0.2|-9.8|
72452937|NCT02307682|144427703|OTHER||Difference in proportions|-5.4|||||TWO_SIDED|95.0|-10.4|-0.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 84||-0.7|-10.4|
72452938|NCT02307682|144427703|OTHER||Difference in proportions|-2.2|||||TWO_SIDED|95.0|-7.4|3.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 88||3.0|-7.4|
72452939|NCT02307682|144427703|OTHER||Difference in proportions|-6.0|||||TWO_SIDED|95.0|-11.0|-1.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 88||-1.1|-11.0|
72562252|NCT00407745|144655833|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.55|STANDARD_ERROR_OF_MEAN|0.368||0.136|TWO_SIDED|95.0|-1.28|0.18||Significance was declared if p-value \<=0.05|ANCOVA|ANCOVA model included terms of baseline QANeP - Cold Allodynia as a covariate and pooled center and treatment as fixed (class) cofactors.||"Below level~Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group."||0.18|-1.28|0.1360
72452940|NCT02307682|144427703|OTHER||Difference in proportions|-0.1|||||TWO_SIDED|95.0|-4.9|5.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 92||5.1|-4.9|
72452941|NCT02307682|144427703|OTHER||Difference in proportions|-3.0|||||TWO_SIDED|95.0|-7.6|1.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 92||1.4|-7.6|
72452942|NCT02307682|144427703|OTHER||Difference in proportions|-0.1|||||TWO_SIDED|95.0|-5.3|5.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 96||5.1|-5.3|
72452943|NCT02307682|144427703|OTHER||Difference in proportions|-3.8|||||TWO_SIDED|95.0|-8.5|0.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 96||0.8|-8.5|
72452944|NCT02307682|144427704|OTHER||Difference in proportions|-6.7|||||TWO_SIDED|95.0|-14.1|0.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 4||0.2|-14.1|
72452945|NCT02307682|144427704|OTHER||Difference in proportions|-7.4|||||TWO_SIDED|95.0|-15.3|-0.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 4||-0.3|-15.3|
72452946|NCT02307682|144427704|OTHER||Difference in proportions|-9.3|||||TWO_SIDED|95.0|-16.6|-2.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 8||-2.2|-16.6|
72452947|NCT02307682|144427704|OTHER||Difference in proportions|-12.1|||||TWO_SIDED|95.0|-19.7|-5.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 8||-5.4|-19.7|
72452948|NCT02307682|144427704|OTHER||Difference in proportions|-8.2|||||TWO_SIDED|95.0|-14.8|-1.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 12||-1.6|-14.8|
72452949|NCT02307682|144427704|OTHER||Difference in proportions|-10.2|||||TWO_SIDED|95.0|-17.4|-3.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 12||-3.9|-17.4|
72452950|NCT02307682|144427704|SUPERIORITY||Difference in proportions|-10.2||||0.003|TWO_SIDED|95.0|-17.3|-2.5||1-sided testing for superiority of brolucizumab 3 mg versus aflibercept 2 mg|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 16||-2.5|-17.3|0.0030
72499397|NCT01587950|144529377|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|5.45||||0.4798|TWO_SIDED|95.0|-9.86|20.76|||ANCOVA|ANCOVA with factors for treatment group, application site, period and random effect for subject|Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.|Null hypothesis suggested that mean change from baseline in the evaporative sensitivity within the treatments was zero, 10 minutes post treatment. Statistical tests were 2-sided with a significance level of 0.05.||20.76|-9.86|0.4798
72562253|NCT00407745|144655834|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.44|STANDARD_ERROR_OF_MEAN|0.549||0.4257|TWO_SIDED|95.0|-1.53|0.65||Significance was declared if p-value \<=0.05|ANCOVA|ANCOVA model included terms of baseline QANeP - Cold Hyperalgesia Subscales as a covariate and pooled center and treatment as fixed (class) cofactors.||"At/Above level~Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group."||0.65|-1.53|0.4257
72562254|NCT00407745|144655834|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.53|STANDARD_ERROR_OF_MEAN|0.412||0.2005|TWO_SIDED|95.0|-1.34|0.28||Significance was declared if p-value \<=0.05|ANCOVA|ANCOVA model included terms of baseline QANeP - Cold Hyperalgesia Subscales as a covariate and pooled center and treatment as fixed (class) cofactors.||"Below level~Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group."||0.28|-1.34|0.2005
72452951|NCT02307682|144427704|SUPERIORITY||Difference in proportions|-18.2|||<|0.0001|TWO_SIDED|95.0|-25.3|-10.9||1-sided testing for superiority of brolucizumab 6 mg versus aflibercept 2 mg|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 16||-10.9|-25.3|<0.0001
72562255|NCT00407745|144655835|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.04|STANDARD_ERROR_OF_MEAN|0.025||0.1377|TWO_SIDED|95.0|-0.09|0.01||Significance was declared if p-value \<=0.05|ANCOVA|ANCOVA model included terms of baseline NPSI - 12 Items Total Intensity Score as covariate and pooled center and treatment as fixed (class) cofactors.||Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group.||0.01|-0.09|0.1377
72562256|NCT00407745|144655836|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.04|STANDARD_ERROR_OF_MEAN|0.038||0.3312|TWO_SIDED|95.0|-0.11|0.04||Significance was declared if p-value \<=0.05|ANCOVA|ANCOVA model included terms of baseline NPSI - Burning Spontaneous Pain as covariate and pooled center and treatment as fixed (class) cofactors.||Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group.||0.04|-0.11|0.3312
72452952|NCT02307682|144427704|OTHER||Difference in proportions|12.0|||||TWO_SIDED|95.0|5.2|19.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 20||19.0|5.2|
72452953|NCT02307682|144427704|OTHER||Difference in proportions|11.1|||||TWO_SIDED|95.0|3.8|18.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 20||18.2|3.8|
72452954|NCT02307682|144427704|OTHER||Difference in proportions|-10.6|||||TWO_SIDED|95.0|-17.7|-3.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 24||-3.1|-17.7|
72452955|NCT02307682|144427704|OTHER||Difference in proportions|-23.2|||||TWO_SIDED|95.0|-30.5|-16.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 24||-16.1|-30.5|
72452956|NCT02307682|144427704|OTHER||Difference in proportions|1.7|||||TWO_SIDED|95.0|-4.8|9.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 28||9.0|-4.8|
72452957|NCT02307682|144427704|OTHER||Difference in proportions|-3.9|||||TWO_SIDED|95.0|-11.8|2.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 28||2.5|-11.8|
72452958|NCT02307682|144427704|OTHER||Difference in proportions|-4.5|||||TWO_SIDED|95.0|-12.0|3.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 32||3.1|-12.0|
72452959|NCT02307682|144427704|OTHER||Difference in proportions|-10.3|||||TWO_SIDED|95.0|-18.0|-3.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 32||-3.2|-18.0|
72452960|NCT02307682|144427704|OTHER||Difference in proportions|-5.9|||||TWO_SIDED|95.0|-12.5|0.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 36||0.8|-12.5|
72562257|NCT00407745|144655837|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.07|STANDARD_ERROR_OF_MEAN|0.033||0.044|TWO_SIDED|95.0|-0.13|0.0||Significance was declared if p-value \<=0.05|ANCOVA|ANCOVA model included terms of baseline NPSI - Pressing Spontaneous Pain as covariate and pooled center and treatment as fixed (class) cofactors.||Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group.||0.00|-0.13|0.0440
72452961|NCT02307682|144427704|OTHER||Difference in proportions|-9.2|||||TWO_SIDED|95.0|-16.2|-2.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 36||-2.4|-16.2|
72452962|NCT02307682|144427704|OTHER||Difference in proportions|-8.2|||||TWO_SIDED|95.0|-15.7|-0.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 40||-0.6|-15.7|
72452963|NCT02307682|144427704|OTHER||Difference in proportions|-13.0|||||TWO_SIDED|95.0|-20.5|-5.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 40||-5.5|-20.5|
72499398|NCT01587950|144529377|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-5.56||||0.4255|TWO_SIDED|95.0|-19.42|8.29|||ANCOVA|ANCOVA with factors for treatment group, application site, period and random effect for subject|Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.|Null hypothesis suggested that mean change from baseline in the evaporative sensitivity within the treatments was zero, 10 minutes post treatment. Statistical tests were 2-sided with a significance level of 0.05.||8.29|-19.42|0.4255
72452964|NCT02307682|144427704|OTHER||Difference in proportions|6.0|||||TWO_SIDED|95.0|-0.8|13.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 44||13.0|-0.8|
72452965|NCT02307682|144427704|OTHER||Difference in proportions|-0.1|||||TWO_SIDED|95.0|-7.5|6.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 44||6.6|-7.5|
72452966|NCT02307682|144427704|SUPERIORITY||Difference in proportions|-10.5||||0.002|TWO_SIDED|95.0|-17.4|-3.3||1-sided testing for superiority of brolucizumab 3 mg versus aflibercept 2 mg|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 48||-3.3|-17.4|0.0020
72452967|NCT02307682|144427704|SUPERIORITY||Difference in proportions|-13.5||||0.0001|TWO_SIDED|95.0|-20.7|-6.1||1-sided testing for superiority of brolucizumab 6 mg versus aflibercept 2 mg|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 48||-6.1|-20.7|0.0001
72499399|NCT01587950|144529378|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.96||||0.7769||95.0|-15.71|11.8||ANCOVA with factors for treatment group, application site, period and random effect for subject.|ANCOVA||Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.|Null hypothesis suggested that mean change from baseline in the evaporative sensitivity within each of the treatment was zero, 20 minutes post treatment. Statistical tests were 2-sided with a significance level of 0.05.||11.80|-15.71|0.7769
72562258|NCT00407745|144655838|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.05|STANDARD_ERROR_OF_MEAN|0.033||0.137|TWO_SIDED|95.0|-0.12|0.02||Significance was declared if p-value \<=0.05|ANCOVA|ANCOVA model included terms of baseline NPSI - Paroxysmal Pain as covariate and pooled center and treatment as fixed (class) cofactors.||Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group.||0.02|-0.12|0.1370
72452968|NCT02307682|144427704|OTHER||Difference in proportions|1.0|||||TWO_SIDED|95.0|-5.4|8.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 52||8.1|-5.4|
72452969|NCT02307682|144427704|OTHER||Difference in proportions|-4.9|||||TWO_SIDED|95.0|-11.8|1.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 52||1.2|-11.8|
72452970|NCT02307682|144427704|OTHER||Difference in proportions|-3.2|||||TWO_SIDED|95.0|-10.3|3.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 56||3.7|-10.3|
72452971|NCT02307682|144427704|OTHER||Difference in proportions|-6.9|||||TWO_SIDED|95.0|-14.1|0.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 56||0.4|-14.1|
72562259|NCT00407745|144655839|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.028||0.8911|TWO_SIDED|95.0|-0.06|0.05||Significance was declared if p-value \<=0.05|ANCOVA|ANCOVA model included terms of baseline NPSI - Evoked pain as covariate and pooled center and treatment as fixed (class) cofactors.||Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group.||0.05|-0.06|0.8911
72452972|NCT02307682|144427704|OTHER||Difference in proportions|-3.8|||||TWO_SIDED|95.0|-10.1|3.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 60||3.3|-10.1|
72452973|NCT02307682|144427704|OTHER||Difference in proportions|-7.1|||||TWO_SIDED|95.0|-14.0|-0.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 60||-0.6|-14.0|
72452974|NCT02307682|144427704|OTHER||Difference in proportions|-7.6|||||TWO_SIDED|95.0|-14.7|-0.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 64||-0.1|-14.7|
72452975|NCT02307682|144427704|OTHER||Difference in proportions|-12.1|||||TWO_SIDED|95.0|-19.5|-5.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 64||-5.4|-19.5|
72452976|NCT02307682|144427704|OTHER||Difference in proportions|7.2|||||TWO_SIDED|95.0|0.3|13.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 68||13.5|0.3|
72452977|NCT02307682|144427704|OTHER||Difference in proportions|2.2|||||TWO_SIDED|95.0|-4.9|8.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 68||8.4|-4.9|
72452978|NCT02307682|144427704|OTHER||Difference in proportions|-8.9|||||TWO_SIDED|95.0|-15.7|-1.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 72||-1.7|-15.7|
72452979|NCT02307682|144427704|OTHER||Difference in proportions|-12.5|||||TWO_SIDED|95.0|-19.8|-5.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 72||-5.6|-19.8|
72452980|NCT02307682|144427704|OTHER||Difference in proportions|0.3|||||TWO_SIDED|95.0|-5.9|7.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 76||7.2|-5.9|
72452981|NCT02307682|144427704|OTHER||Difference in proportions|-3.4|||||TWO_SIDED|95.0|-9.8|2.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 76||2.6|-9.8|
72391658|NCT01447433|144290649|SUPERIORITY_OR_OTHER||Median Difference (Net)|-0.02|STANDARD_ERROR_OF_MEAN|0.15||0.647|TWO_SIDED|95.0|-0.11|0.05|||t-test, 2 sided|||LDL||0.05|-0.11|0.647
72391659|NCT01447433|144290650|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.13|STANDARD_ERROR_OF_MEAN|0.11||0.26|TWO_SIDED|95.0|-0.1|0.35|||t-test, 2 sided|||||0.35|-0.10|0.260
72391660|NCT01447433|144290651|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.87|STANDARD_ERROR_OF_MEAN|1.63||0.598|TWO_SIDED|95.0|-2.44|4.17|||t-test, 2 sided|||||4.17|-2.44|0.598
72391661|NCT01447433|144290652|SUPERIORITY_OR_OTHER||Mean Difference (Net)|98.5|STANDARD_ERROR_OF_MEAN|89.0||0.275|TWO_SIDED|95.0|-81.6|278.7|||t-test, 2 sided|||||278.7|-81.6|0.275
72391662|NCT00036270|144290653|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.89||||0.118|TWO_SIDED|95.0|0.77|1.03|||Log Rank|Log rank (Mantel-Cox). Adjusted for overall stratification factor; 1 degree of freedom.|A hazard ratio less than 1 favors the test treatment (exemestane only arm).|"Analysis at 2.75 years post-randomization. Null hypothesis: no difference in DFS between the two treatments for the first 2.75 years.~To maintain overall alpha of 0.05, 2 adjustments made: first, a nominal alpha of 0.0302 was used for the primary endpoint. Second, level of significant was 0.0012 for interim analysis."||1.03|0.77|0.118
72391663|NCT00036270|144290654|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.97||||0.604|TWO_SIDED|95.0|0.88|1.08|||Log Rank|Log rank (Mantel-Cox). Adjusted for overall stratification factor; 1 degree of freedom.|A hazard ratio less than 1 favors the test treatment (exemestane only arm).|"Analysis at 5 years post-randomization. Null hypothesis: no difference in DFS between the two treatments for the first 5 years.~To maintain overall alpha of 0.05, a nominal alpha of 0.0302 was used."||1.08|0.88|0.604
72391664|NCT00036270|144290655|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.0||||0.951|TWO_SIDED|95.0|0.89|1.14|||Log Rank|Log rank (Mantel-Cox). Adjusted for overall stratification factor; 1 degree of freedom.|A hazard ratio less than 1 favors the test treatment (exemestane only arm).|Analysis at 5 years post-randomization. Null hypothesis: no difference in OS between the two treatments for the first 5 years. Overall alpha of 0.05 was maintained.||1.14|0.89|0.951
72499400|NCT01587950|144529378|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-6.32||||0.3811|TWO_SIDED|95.0|-20.64|8.0|||ANCOVA|ANCOVA with factors for treatment group, application site, period and random effect for subject.|Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.|Null hypothesis suggested that mean change from baseline in the evaporative sensitivity within each of the treatment was zero, 20 minutes post treatment. Statistical tests were 2-sided with a significance level of 0.05.||8.00|-20.64|0.3811
72499401|NCT01587950|144529378|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-4.36||||0.5044||95.0|-17.35|8.63|||ANCOVA|ANCOVA with factors for treatment group, application site, period and random effect for subject.|Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.|Null hypothesis suggested that mean change from baseline in the evaporative sensitivity within each of the treatment was zero, 20 minutes post treatment. Statistical tests were 2-sided with a significance level of 0.05.||8.63|-17.35|0.5044
72562260|NCT00407745|144655840|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.03|STANDARD_ERROR_OF_MEAN|0.034||0.3731|TWO_SIDED|95.0|-0.1|0.04||Significance was declared if p-value \<=0.05|ANCOVA|ANCOVA model included terms of baseline NPSI - Paresthesia/Dysesthesia as covariate and pooled center and treatment as fixed (class) cofactors.||Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group.||0.04|-0.10|0.3731
72620122|NCT02722330|144771163|SUPERIORITY_OR_OTHER|||||||0.096|||||||Wilcoxon Signed Rank test|||SPL 50 dB||||0.096
72620123|NCT02722330|144771163|SUPERIORITY_OR_OTHER|||||||1|||||||Wilcoxon Signed Rank test|||SPL 65 dB||||1.00
72391665|NCT00036270|144290657|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.94||||0.293|TWO_SIDED|95.0|0.83|1.06|||Log Rank|Log rank (Mantel-Cox). Adjusted for overall stratification factor; 1 degree of freedom.|A hazard ratio less than 1 favors the test treatment (exemestane only arm).|Analysis at 5 years post-randomization. Null hypothesis: no difference in time to relapse between the two treatments for the first 5 years. Overall alpha of 0.05 was maintained.||1.06|0.83|0.293
72391666|NCT01964430|144290659|SUPERIORITY||Hazard Ratio (HR)|0.88||||0.1824|TWO_SIDED|95.0|0.729|1.063|||Log Rank|Stratified by resection status (R0 versus R1) and nodal status (LN+ versus LN).|Estimated using stratified Cox proportional hazards model adjusting for strata of resection status (R0 versus R1) and nodal status (LN+ versus LN-).|||1.063|0.729|0.1824
72391667|NCT01964430|144290660|SUPERIORITY||Hazard Ratio (HR)|0.81||||0.0128|TWO_SIDED|95.0|0.691|0.957|||Log Rank|Stratified by resection status (R0 versus. R1) and nodal status (LN+ versus. LN-)|Estimated using stratified Cox proportional hazards model adjusting for strata of resection status (R0 versus R1) and nodal status (LN+ versus|||0.957|0.691|0.0128
72391668|NCT02446483|144290668|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was established when 90% Confidence Interval falls within 80-125%.|Point Estimate Percent|101.32|||||TWO_SIDED|90.0|95.81|107.15||||||||107.15|95.81|
72391669|NCT02446483|144290669|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence is established when 90% Confidence Interval falls within 80-125%.|Point Estimate Percent|98.71|||||TWO_SIDED|90.0|92.54|105.28||||||Comparison of T- rabeprazole 20 mg and R- rabeprazole 20 mg for AUC0-t.||105.28|92.54|
72391670|NCT02446483|144290669|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence is established when 90% Confidence Interval falls within 80-125%.|Point Estimate Percent|98.05|||||TWO_SIDED|90.0|91.81|104.71||||||Comparison of Treatment A- rabeprazole 20 mg and Treatment B- rabeprazole 20 mg for AUC0-infinity.||104.71|91.81|
72391671|NCT02446483|144290670|SUPERIORITY_OR_OTHER|||||||0.0029||95.0|||||Wilcoxon's Signed-Rank Test|||||||0.0029
72391672|NCT03334539|144290723|SUPERIORITY||Least Squares (LS) Mean Difference|0.11||||0.3378|TWO_SIDED|95.0|-0.12|0.34||P-value was calculated using a model with treatment, baseline score, and site as covariates.|ANCOVA|||||0.34|-0.12|0.3378
72499402|NCT01587950|144529378|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-5.68||||0.4374|TWO_SIDED|95.0|-20.2|8.84|||ANCOVA|ANCOVA with factors for treatment group, application site, period and random effect for subject.|Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.|Null hypothesis suggested that mean change from baseline in the evaporative sensitivity within the treatments was zero, 20 minutes post treatment. Statistical tests were 2-sided with a significance level of 0.05.||8.84|-20.20|0.4374
72620124|NCT02722330|144771163|SUPERIORITY_OR_OTHER|||||||0.41|||||||Wilcoxon Signed Rank test|||SPL 80 dB||||0.41
72452982|NCT02307682|144427704|OTHER||Difference in proportions|-4.4|||||TWO_SIDED|95.0|-11.2|2.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 80||2.5|-11.2|
72452983|NCT02307682|144427704|OTHER||Difference in proportions|-8.1|||||TWO_SIDED|95.0|-15.3|-1.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 80||-1.0|-15.3|
72452984|NCT02307682|144427704|OTHER||Difference in proportions|-2.1|||||TWO_SIDED|95.0|-8.9|4.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 84||4.6|-8.9|
72452985|NCT02307682|144427704|OTHER||Difference in proportions|-4.5|||||TWO_SIDED|95.0|-11.2|1.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 84||1.7|-11.2|
72452986|NCT02307682|144427704|OTHER||Difference in proportions|-3.8|||||TWO_SIDED|95.0|-10.8|3.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 88||3.7|-10.8|
72452987|NCT02307682|144427704|OTHER||Difference in proportions|-10.3|||||TWO_SIDED|95.0|-17.3|-3.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 88||-3.5|-17.3|
72499403|NCT01587950|144529378|SUPERIORITY_OR_OTHER||Slope|-4.02||||0.5796|TWO_SIDED|95.0|-18.46|10.41|||ANCOVA|ANCOVA with factors for treatment group, application site, period and random effect for subject|Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.|Null hypothesis suggested that mean change from baseline in the evaporative sensitivity within the treatments was zero, 20 minutes post treatment. Statistical tests were 2-sided with a significance level of 0.05.||10.41|-18.46|0.5796
72499404|NCT01587950|144529378|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|1.66||||0.7994|TWO_SIDED|95.0|-11.32|14.64|||ANCOVA|ANCOVA with factors for treatment group, application site, period and random effect for subject|Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|Null hypothesis suggested that mean change from baseline in the evaporative sensitivity within the treatments was zero, 20 minutes post treatment. Statistical tests were 2-sided with a significance level of 0.05||14.64|-11.32|0.7994
72499405|NCT01587950|144529378|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|7.75||||0.2784|TWO_SIDED|95.0|-6.42|21.93|||ANCOVA|ANCOVA with factors for treatment group, application site, period and random effect for subject|Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.|Null hypothesis suggested that mean change from baseline in the evaporative sensitivity within the treatments was zero, 20 minutes post treatment. Statistical tests were 2-sided with a significance level of 0.05.||21.93|-6.42|0.2784
72620125|NCT01934231|144771169|SUPERIORITY_OR_OTHER||Rate of Cure|88.5|||||TWO_SIDED|95.0|69.85|97.55|||||"The estimated parameter represents the rate of cure, calculated as (number of participants with an outcome of Cure/number of participants analyzed) \* 100."|||97.55|69.85|
72452988|NCT02307682|144427704|OTHER||Difference in proportions|4.1|||||TWO_SIDED|95.0|-2.3|11.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 92||11.0|-2.3|
72452989|NCT02307682|144427704|OTHER||Difference in proportions|-3.0|||||TWO_SIDED|95.0|-9.8|2.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 92||2.6|-9.8|
72452990|NCT02307682|144427704|OTHER||Difference in proportions|-6.4|||||TWO_SIDED|95.0|-13.2|0.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 96||0.7|-13.2|
72499406|NCT01587950|144529378|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|6.68||||0.3581|TWO_SIDED|95.0|-7.75|21.12|||ANCOVA|ANCOVA with factors for treatment group, application site, period and random effect for subject|Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.|Null hypothesis suggested that mean change from baseline in the evaporative sensitivity within the treatments was zero, 20 minutes post treatment. Statistical tests were 2-sided with a significance level of 0.05.||21.12|-7.75|0.3581
72499407|NCT01587950|144529378|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.07||||0.8703|TWO_SIDED|95.0|-14.11|11.97|||ANCOVA|ANCOVA with factors for treatment group, application site, period and random effect for subject|Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.|Null hypothesis suggested that mean change from baseline in the evaporative sensitivity within the treatments was zero, 20 minutes post treatment. Statistical tests were 2-sided with a significance level of 0.05.||11.97|-14.11|0.8703
72499408|NCT04211337|144529395|SUPERIORITY||Hazard Ratio (HR)|0.28|||<|0.0001|TWO_SIDED|95.0|0.165|0.475|||Log Rank|Stratified by RET mutation type (M918T vs. Others) and intended treatment if randomized to Arm B (Vandetanib vs. Cabozantinib).|Stratified by RET mutation type (M918T vs. Others) and intended treatment if randomized to Arm B (Vandetanib vs. Cabozantinib).|||0.475|0.165|<0.0001
72499409|NCT04211337|144529396|SUPERIORITY||Hazard Ratio (HR)|0.254|||<|0.0001|TWO_SIDED|95.0|0.153|0.423|||Log Rank|Stratified by RET mutation type (M918T vs. Others) and intended treatment if randomized to Arm B (Vandetanib vs. Cabozantinib).|Stratified by RET mutation type (M918T vs. Others) and intended treatment if randomized to Arm B (Vandetanib vs. Cabozantinib).|||0.423|0.153|<0.0001
72499410|NCT04211337|144529397|SUPERIORITY||Odds Ratio (OR)|3.7|||<|0.0001|TWO_SIDED|95.0|2.2|6.3||Stratified by RET mutation type (M918T vs. Others) and intended treatment if randomized to Arm B (Vandetanib vs. Cabozantinib)|Clopper-Pearson method|||||6.3|2.2|<0.0001
72499411|NCT04211337|144529398|SUPERIORITY||Hazard Ratio (HR)|0.275||||0.0004|TWO_SIDED|95.0|0.129|0.587|||Log Rank|Stratified by RET mutation type (M918T vs. Others) and intended treatment if randomized to Arm B (Vandetanib vs. Cabozantinib).||||0.587|0.129|0.0004
72499412|NCT04211337|144529401|SUPERIORITY||Mean Difference (Final Values)|-0.16|||<|0.0001|TWO_SIDED|95.0|-0.23|-0.1||Stratified by RET mutation type (M918T vs. Others) and intended treatment if randomized to Arm B (Vandetanib vs. Cabozantinib).|Wilcoxon (Mann-Whitney)|||||-0.10|-0.23|<0.0001
72499413|NCT02847598|144529433|SUPERIORITY||Least squares (LS) mean Difference|-3.4||||0.037|TWO_SIDED|95.0|-6.7|-0.2|||MMRM|||A Mixed Effect Model Repeat Measurement (MMRM) model is performed, using treatment group, study visit, baseline corticosteroid usage level (\<=10 mg, \>10 mg), region, study visit-by-treatment interaction, baseline value of the outcome measure, and baseline-by-visit interaction as fixed effect covariates. Statistical analysis for placebo and BIIB059 450 mg was planned and reported.||-0.2|-6.7|0.037
72562261|NCT00407745|144655841|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.37|STANDARD_ERROR_OF_MEAN|0.383||0.3312|TWO_SIDED|95.0|-1.13|0.38||Significance was declared if p-value \<=0.05|ANCOVA|ANCOVA model included terms of baseline NPSI - Individual Item Score as covariate and pooled center and treatment as fixed (class) cofactors.||"Item 1 - Burning pain~Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group."||0.38|-1.13|0.3312
72562262|NCT00407745|144655841|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.63|STANDARD_ERROR_OF_MEAN|0.377||0.0976|TWO_SIDED|95.0|-1.37|0.12||Significance was declared if p-value \<=0.05|ANCOVA|ANCOVA model included terms of baseline NPSI - Individual Item Score as covariate and pooled center and treatment as fixed (class) cofactors.||"Item 2 - Squeezing pain~Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group."||0.12|-1.37|0.0976
72620126|NCT00382863|144771184|SUPERIORITY_OR_OTHER|||||||0.502|||||||Fisher Exact|One-sided||Null hypothesis = proportion of subjects in treatment group who successfully achieved an improvement of at least 1.0 ml/kg/min at 6 months is less than or equal to the Control group. Subjects who withdrew for cardiac-related reasons were classified as non-responders.||||0.502
72391673|NCT03334539|144290723|SUPERIORITY||LS Mean Difference|0.12||||0.2883|TWO_SIDED|95.0|-0.1|0.35||P-value was calculated using a model with treatment, baseline score, and site as covariates.|ANCOVA|||||0.35|-0.10|0.2883
72391674|NCT03334539|144290723|OTHER||LS Mean Difference|0.01||||0.9293|TWO_SIDED|95.0|-0.22|0.24||P-value calculated using a model with treatment, baseline score, and site as covariates|ANCOVA|||||0.24|-0.22|0.9293
72499414|NCT02847598|144529434|SUPERIORITY||LS mean difference|-24.29||||0.015|TWO_SIDED|95.0|-43.7|-4.88|||MMRM|||A MMRM model is performed, using treatment group, study visit, study visit-by-treatment interaction, DLE (Yes/No), CLASI-A score (\<=10 vs. \>10) as fixed effect covariates.||-4.88|-43.70|0.015
72499415|NCT02847598|144529434|SUPERIORITY||LS mean difference|-33.42|||<|0.001|TWO_SIDED|95.0|-52.71|-14.12|||MMRM|||A MMRM model is performed, using treatment group, study visit, study visit-by-treatment interaction, DLE (Yes/No), CLASI-A score (\<=10 vs. \>10) as fixed effect covariates.||-14.12|-52.71|<0.001
72499416|NCT02847598|144529434|SUPERIORITY||LS mean difference|-27.99||||0.001|TWO_SIDED|95.0|-44.55|-11.42|||MMRM|||A MMRM model is performed, using treatment group, study visit, study visit-by-treatment interaction, DLE (Yes/No), CLASI-A score (\<=10 vs. \>10) as fixed effect covariates.||-11.42|-44.55|0.001
72499417|NCT02847598|144529437|SUPERIORITY||LS Mean Difference|-9.93||||0.22|TWO_SIDED|95.0|-25.94|6.08|||MMRM|||Week 12: A MMRM model is performed, using treatment group study visit, baseline corticosteroid usage level (\<=10 mg, \>10 mg), region, study visit-by-treatment interaction, baseline value of the outcome measure, and baseline-by-visit interaction as fixed effect covariates. Statistical analysis for placebo and BIIB059 450 mg was planned and reported.||6.08|-25.94|0.220
72499418|NCT02847598|144529437|SUPERIORITY||LS Mean Difference|-8.96||||0.293|TWO_SIDED|95.0|-25.82|7.9|||MMRM|||Week 16: A MMRM model is performed, using treatment group (BIIB059 450 mg vs. placebo), study visit, baseline corticosteroid usage level (\<=10 mg, \>10 mg), region study visit-by-treatment interaction, baseline value of the endpoint, and baseline-by-visit interaction as fixed effect covariates. Statistical analysis for placebo and BIIB059 450 mg was planned and reported.||7.90|-25.82|0.293
72499419|NCT02847598|144529437|SUPERIORITY||LS Mean Difference|-15.74||||0.062|TWO_SIDED|95.0|-32.28|0.79|||MMRM|||Week 24: A MMRM model is performed, using treatment group, study visit, baseline corticosteroid usage level (\<=10 mg, \>10 mg), region study visit-by-treatment interaction, baseline value of the outcome measure, and baseline-by-visit interaction as fixed effect covariates. Statistical analysis for placebo and BIIB059 450 mg was planned and reported.||0.79|-32.28|0.062
72499420|NCT02847598|144529438|SUPERIORITY||LS mean difference|-30.36||||0.001|TWO_SIDED|95.0|-48.75|-11.97|||MMRM|||A MMRM model is performed, using treatment group, study visit, study visit-by-treatment interaction, DLE (Yes/No), CLASI-A score (\<=10 vs. \>10) as fixed effect covariates.||-11.97|-48.75|0.001
72499421|NCT02847598|144529438|SUPERIORITY||LS mean difference|-37.17|||<|0.001|TWO_SIDED|95.0|-55.46|-18.87|||MMRM|||A MMRM model is performed, using treatment group, study visit, study visit-by-treatment interaction, DLE (Yes/No), CLASI-A score (\<=10 vs. \>10) as fixed effect covariates.||-18.87|-55.46|<0.001
72499422|NCT02847598|144529438|SUPERIORITY||LS mean difference|-26.05||||0.001|TWO_SIDED|95.0|-41.71|-10.4|||MMRM|||A MMRM model is performed, using treatment group, study visit, study visit-by-treatment interaction, DLE (Yes/No), CLASI-A score (\<=10 vs. \>10) as fixed effect covariates.||-10.40|-41.71|0.001
72452991|NCT02307682|144427704|OTHER||Difference in proportions|-12.9|||||TWO_SIDED|95.0|-19.7|-6.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 96||-6.6|-19.7|
72452992|NCT02307682|144427705|SUPERIORITY|||||||0.0574||||||1-sided testing for superiority of brolucizumab 3 mg versus aflibercept 2 mg|Cochran-Mantel-Haenszel|CMH-test row mean score (scores=table) stratified by age categories (\<75, ≥75 years) and baseline fluid status)||||||0.0574
72452993|NCT02307682|144427705|SUPERIORITY|||||||0.0012||||||1-sided testing for superiority of brolucizumab 6 mg versus aflibercept 2 mg|Cochran-Mantel-Haenszel|CMH-test row mean score (scores=table) stratified by age categories (\<75, ≥75 years) and baseline fluid status)||||||0.0012
72452994|NCT02307682|144427706|SUPERIORITY||difference in proportions|-6.5||||0.0331|TWO_SIDED|95.0|-13.2|0.3||1-sided testing for superiority of brolucizumab 3 mg versus aflibercept 2 mg|Regression, Logistic||Statistical model used logistic regression adjusting for age categories (\<75, \>=75 years) and treatment as fixed effect factors. 95% CI for the treatment difference estimated using bootstrap method.|||0.3|-13.2|0.0331
72452995|NCT02307682|144427706|SUPERIORITY||difference in proportions|-10.5||||0.0013|TWO_SIDED|95.0|-17.1|-3.5||1-sided testing for superiority of brolucizumab 6 mg versus aflibercept 2 mg|Regression, Logistic||Statistical model used logistic regression adjusting for age categories (\<75, \>=75 years) and treatment as fixed effect factors. 95% CI for the treatment difference estimated using bootstrap method.|||-3.5|-17.1|0.0013
72452996|NCT02307682|144427707|OTHER|Treatment difference|Least squares mean difference|0.9|||||TWO_SIDED|95.0|-0.5|2.3||Hypothesis testing not pre-specified|ANCOVA|Analyzed using pairwise ANCOVA model with treatment as a fixed effect factor and corresponding baseline value of the endpoint as a covariate.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 24||2.3|-0.5|
72452997|NCT02307682|144427707|OTHER|Treatment difference|Least squares mean difference|0.63|||||TWO_SIDED|95.0|-0.9|2.1||Hypothesis testing not pre-specified|ANCOVA|Analyzed using pairwise ANCOVA model with treatment as a fixed effect factor and corresponding baseline value of the endpoint as a covariate.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 24||2.1|-0.9|
72452998|NCT02307682|144427707|OTHER|Treatment difference|Least squares mean difference|-0.2|||||TWO_SIDED|95.0|-1.8|1.4||Hypothesis testing not pre-specified.|ANCOVA|Analyzed using pairwise ANCOVA model with treatment as a fixed effect factor and corresponding baseline value of the endpoint as a covariate.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 48||1.4|-1.8|
72452999|NCT02307682|144427707|OTHER|Treatment difference|Least squares mean difference|-0.26|||||TWO_SIDED|95.0|-1.9|1.4||Hypothesis testing not pre-specified.|ANCOVA|Analyzed using pairwise ANCOVA model with treatment as a fixed effect factor and corresponding baseline value of the endpoint as a covariate.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 48||1.4|-1.9|
72453000|NCT02307682|144427707|OTHER|Treatment difference|Least squares mean difference|0.18|||||TWO_SIDED|95.0|-1.6|1.9||Hypothesis testing not pre-specified.|ANCOVA|Analyzed using pairwise ANCOVA model with treatment as a fixed effect factor and corresponding baseline value of the endpoint as a covariate.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 72||1.9|-1.6|
72453001|NCT02307682|144427707|OTHER|Treatment difference|Least squares mean difference|-0.12|||||TWO_SIDED|95.0|-1.9|1.7||Hypothesis testing not pre-specified|ANCOVA|Analyzed using pairwise ANCOVA model with treatment as a fixed effect factor and corresponding baseline value of the endpoint as a covariate.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 72||1.7|-1.9|
72499423|NCT02847598|144529444|SUPERIORITY||LS Mean Difference|-1.7||||0.007|TWO_SIDED|95.0|-3.0|-0.5|||MMRM|||A MMRM model is performed, using treatment group, study visit, baseline corticosteroid usage level (\<=10 mg, \>10 mg), region, study visit-by-treatment interaction, baseline value of the outcome measure, and baseline-by-visit interaction as fixed effect covariates. Statistical analysis for placebo and BIIB059 450 mg was planned and reported.||-0.5|-3.0|0.007
72499424|NCT02847598|144529446|SUPERIORITY||LS mean difference|-0.16||||0.667|TWO_SIDED|95.0|-0.9|0.58|||MMRM|||A MMRM model is performed, using treatment group (BIIB059 450 mg vs. placebo), study visit, baseline corticosteroid usage level (\<=10 mg, \>10 mg), region, study visit-by-treatment interaction, baseline value of the endpoint, and baseline-by-visit interaction as fixed effect covariates. Statistical analysis for placebo and BIIB059 450 mg was planned and reported.||0.58|-0.90|0.667
72499425|NCT02848833|144529474|OTHER||||||<|0.0001||||||Difference before administration versus after administration was analyzed using a paired t-test.|paired t-test|||||||<0.0001
72499426|NCT02848833|144529477|OTHER||||||<|0.0001||||||Difference before administration versus after administration was analyzed using a paired t-test.|paired t-test|||||||<0.0001
72499427|NCT02848833|144529478|OTHER|Difference before administration versus after administration was analyzed using a paired t-test.|||||<|0.0001|||||||paired t-test|||||||<0.0001
72499428|NCT02848833|144529479|OTHER||||||<|0.0001||||||Difference before administration versus after administration was analyzed using a paired t-test.|paired t-test|||||||<0.0001
72499429|NCT02848833|144529480|OTHER||||||<|0.0001||||||Difference before administration versus after administration was analyzed using a paired t-test.|paired t-test|||||||<0.0001
72499430|NCT04167345|144529482|SUPERIORITY||Mean Difference|1.7|||<|0.0001|TWO_SIDED|95.0|1.1|2.3|||t-test, 2 sided|||||2.3|1.1|<.0001
72499431|NCT04167345|144529482|SUPERIORITY||Mean Difference|2.0|||<|0.0001|TWO_SIDED|95.0|1.1|2.9|||t-test, 2 sided|||||2.9|1.1|<.0001
72499432|NCT04167345|144529484|SUPERIORITY||Mean Difference|2.0||||0.0114|TWO_SIDED|95.0|0.5|3.4|||t-test, 2 sided|||||3.4|0.5|0.0114
72499433|NCT04167345|144529484|SUPERIORITY||Mean Difference|2.3||||0.0009|TWO_SIDED|95.0|1.1|3.5|||t-test, 2 sided|||||3.5|1.1|0.0009
72499434|NCT00960076|144529507|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.52|STANDARD_ERROR_OF_MEAN|0.108|||TWO_SIDED|95.0|-0.73|-0.31||||||||-0.31|-0.73|
72499435|NCT00960076|144529508|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-23.32|STANDARD_ERROR_OF_MEAN|7.128|||TWO_SIDED|95.0|-37.36|-9.28||||||||-9.28|-37.36|
72499436|NCT00960076|144529509|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-13.18|STANDARD_ERROR_OF_MEAN|4.409|||TWO_SIDED|95.0|-21.86|-4.5||||||||-4.50|-21.86|
72499437|NCT00960076|144529510|SUPERIORITY_OR_OTHER||Mean Difference (Net)|11.2||||0.0459|TWO_SIDED|95.0|0.2|22.0|||ANCOVA|||||22.0|0.2|0.0459
72453002|NCT02307682|144427707|OTHER|Treatment difference|Least squares mean difference|0.75|||||TWO_SIDED|95.0|-1.2|2.7||Hypothesis testing not pre-specified|ANCOVA|Analyzed using pairwise ANCOVA model with treatment as a fixed effect factor and corresponding baseline value of the endpoint as a covariate.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 96||2.7|-1.2|
72453003|NCT02307682|144427707|OTHER|Treatment difference|Least squares mean difference|1.05|||||TWO_SIDED|95.0|-0.9|3.0||Hypothesis testing not pre-specified.|ANCOVA|nalyzed using pairwise ANCOVA model with treatment as a fixed effect factor and corresponding baseline value of the endpoint as a covariate.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 96||3.0|-0.9|
72453004|NCT05630833|144427711|OTHER||Lower 10th percentile (%)|48.2|||||||||||||Lower 10th percentile of therapeutic successes was calculated from the predictive distribution.|As defined in Statistical Analysis Plan, consistency with the global studies is demonstrated if the success criterion for gepotidacin is set to require a therapeutic response rate greater than lower 10th percentile value of the predictive distribution.||||
72453005|NCT03905694|144427746|OTHER|Not applied|Least Squares (LS) Mean|-71.97|||||TWO_SIDED|95.0|-77.52|-66.42|||Mixed model for repeated measures (MMRM)|||Mixed-effect Model Repeated Measures (MMRM) includes scheduled visits (months 3, 4, 5, and 6) and baseline spot urinary oxalate:creatine ratio as fixed effects. Autoregressive (1) was used to model the within-patient error.||-66.42|-77.52|
72453006|NCT00945321|144427771|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence Bounds of (0.80, 1.25).|Least-Squares Mean Ratio|0.93||||0.001|TWO_SIDED|95.0|0.84|1.02||Hochberg's step-up procedure was applied to preserve the overall alpha level for the primary hypothesis that involved comparison at two oral dose levels.|two one-sided tests|The P-value obtained was the maximum of two P-values from two one-sided tests (GMR (Oral/IV) ≤0.80 vs. GMR\>0.80 and GMR≥1.25 vs. GMR\<1.25).||||1.02|0.84|0.001
72453007|NCT00945321|144427771|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence Bounds of (0.80, 1.25).|Least-Squares Mean Ratio|1.05|||<|0.001|TWO_SIDED|95.0|0.96|1.15||Hochberg's step-up procedure was applied to preserve the overall alpha level for the primary hypothesis that involved comparison at two oral dose levels|two one-sided tests|The P-value obtained was the maximum of two P-values from two one-sided tests (GMR (Oral/IV) ≤0.80 vs. GMR\>0.80 and GMR≥1.25 vs. GMR\<1.25).||||1.15|0.96|<0.001
72453008|NCT00945321|144427771|SUPERIORITY_OR_OTHER||Least-Squares Mean Ratio|1.47|||||TWO_SIDED|90.0|1.23|1.76||||||The effect of a standard high-fat breakfast and a standard light breakfast on aprepitant plasma pharmacokinetics (AUC0-∞ and Cmax) following a single 165 mg oral dose of aprepitant and following a single 185 mg oral dose of aprepitant will be estimated in healthy young adult subjects||1.76|1.23|
72453009|NCT00945321|144427771|SUPERIORITY_OR_OTHER||Least-Squares Mean Ratio|1.08|||||TWO_SIDED|90.0|0.88|1.32||||||The effect of a standard high-fat breakfast and a standard light breakfast on aprepitant plasma pharmacokinetics (AUC0-∞ and Cmax) following a single 165 mg oral dose of aprepitant and following a single 185 mg oral dose of aprepitant will be estimated in healthy young adult subjects||1.32|0.88|
72499438|NCT01431287|144529514|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.132|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|0.108|0.157||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.157|0.108|<0.0001
72453010|NCT00945321|144427771|SUPERIORITY_OR_OTHER||Least-Squares Mean Ratio|1.22|||||TWO_SIDED|90.0|1.01|1.46||||||The effect of a standard high-fat breakfast and a standard light breakfast on aprepitant plasma pharmacokinetics (AUC0-∞ and Cmax) following a single 165 mg oral dose of aprepitant and following a single 185 mg oral dose of aprepitant will be estimated in healthy young adult subjects||1.46|1.01|
72453011|NCT00945321|144427771|SUPERIORITY_OR_OTHER||Least-Squares Mean Ratio|1.43|||||TWO_SIDED|90.0|1.16|1.75||||||The effect of a standard high-fat breakfast and a standard light breakfast on aprepitant plasma pharmacokinetics (AUC0-∞ and Cmax) following a single 165 mg oral dose of aprepitant and following a single 185 mg oral dose of aprepitant will be estimated in healthy young adult subjects||1.75|1.16|
72453012|NCT00945321|144427772|SUPERIORITY_OR_OTHER||Least-Squares Mean Ratio|1.33|||||TWO_SIDED|90.0|1.13|1.56||||||The effect of a standard high-fat breakfast and a standard light breakfast on aprepitant plasma pharmacokinetics (AUC0-∞ and Cmax) following a single 165 mg oral dose of aprepitant and following a single 185 mg oral dose of aprepitant will be estimated in healthy young adult subjects||1.56|1.13|
72499439|NCT01431287|144529514|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.103|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|0.078|0.127||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.127|0.078|<0.0001
72620127|NCT00382863|144771185|SUPERIORITY_OR_OTHER|||||||0.044|||||||Fisher Exact|One-sided||The null hypothesis = the proportion of subjects in the treatment group who successfully achieved an improvement of at least 45 m at 6 months from baseline is less than or equal to that of the Control group. Withdrawals due to cardiac reasons are counted as non-responders.||||0.044
72453013|NCT00945321|144427772|SUPERIORITY_OR_OTHER||Least-Squares Mean Ratio|1.04|||||TWO_SIDED|95.0|0.86|1.25||||||The effect of a standard high-fat breakfast and a standard light breakfast on aprepitant plasma pharmacokinetics (AUC0-∞ and Cmax) following a single 165 mg oral dose of aprepitant and following a single 185 mg oral dose of aprepitant will be estimated in healthy young adult subjects||1.25|0.86|
72499440|NCT01431287|144529514|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.121|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|0.096|0.145||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.145|0.096|< 0.0001
72620128|NCT00382863|144771186|SUPERIORITY_OR_OTHER|||||||0.184|||||||Fisher Exact|One-sided||The null hypothesis = the proportion of treatment subjects who successfully achieved an improvement of at least 7 points at 6 months is equal to or less than that of the control group. Withdrawals due to cardiac reasons are counted as non-responders.||||0.184
72499441|NCT01431287|144529514|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.131|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|0.106|0.155||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.155|0.106|<0.0001
72499442|NCT01431287|144529514|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.091|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|0.066|0.115||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.115|0.066|<0.0001
72499443|NCT01431287|144529514|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.012|STANDARD_ERROR_OF_MEAN|0.012||0.3394|TWO_SIDED|95.0|-0.013|0.036||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.036|-0.013|0.3394
72453014|NCT00945321|144427772|SUPERIORITY_OR_OTHER||Least-Squares Mean Ratio|1.14|||||TWO_SIDED|90.0|0.96|1.34||||||The effect of a standard high-fat breakfast and a standard light breakfast on aprepitant plasma pharmacokinetics (AUC0-∞ and Cmax) following a single 165 mg oral dose of aprepitant and following a single 185 mg oral dose of aprepitant will be estimated in healthy young adult subjects||1.34|0.96|
72453015|NCT00945321|144427772|SUPERIORITY_OR_OTHER||Least-Squares Mean Ratio|1.4|||||TWO_SIDED|90.0|1.16|1.68||||||The effect of a standard high-fat breakfast and a standard light breakfast on aprepitant plasma pharmacokinetics (AUC0-∞ and Cmax) following a single 165 mg oral dose of aprepitant and following a single 185 mg oral dose of aprepitant will be estimated in healthy young adult subjects||1.68|1.16|
72453016|NCT00692913|144427777|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.2|||<|0.001||95.0|0.12|0.35|||Regression, Logistic|The logistic regression model was adjusted by baseline 25-hydroxyvitamin D (25(OH)D) level stratum, age, and region.||||0.35|0.12|<0.001
72453017|NCT00692913|144427778|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least-squares means|-9.7|||<|0.001||95.0|-14.49|-4.93|||Longitudinal Data Analysis Model|The model was adjusted by baseline 25-hydroxyvitamin D level stratum, age, and region.||||-4.93|-14.49|<0.001
72453018|NCT00692913|144427779|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least-squares mean|-7.07|||<|0.001||95.0|-10.95|-3.2|||Longitudinal Data Analysis Model|The model was adjusted by baseline 25-hydroxyvitamin D level stratum, age, and region.||||-3.20|-10.95|<0.001
72499444|NCT01431287|144529514|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.143|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|0.118|0.167||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.167|0.118|<0.0001
72620129|NCT00382863|144771187|NON_INFERIORITY_OR_EQUIVALENCE|Estimated survival for the treatment group was 93%. Estimated survival for the control group was 91.5%. A non-inferiority margin of 7.5%. Final test alpha level of 0.04825.||||||0.012|||||||Exact binomial test|One-sided||The null hypothesis = survival in the treatment group at 12 months is not equivalent to that of the Control group.||||0.012
72453019|NCT00692913|144427780|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.21|||<|0.001||95.0|0.13|0.35|||Regression, Logistic|The logistic regression model was adjusted by baseline 25-hydroxyvitamin D level stratum, age, and region.||||0.35|0.13|<0.001
72499445|NCT01431287|144529514|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.03|STANDARD_ERROR_OF_MEAN|0.012||0.0173|TWO_SIDED|95.0|0.005|0.054||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.054|0.005|0.0173
72499446|NCT01431287|144529514|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.01|STANDARD_ERROR_OF_MEAN|0.013||0.421|TWO_SIDED|95.0|-0.035|0.014||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.014|-0.035|0.4210
72620130|NCT00382863|144771188|SUPERIORITY_OR_OTHER|||||||0.052|||||||Wilcoxon (Mann-Whitney)|||Class change from baseline.||||0.052
72453020|NCT00692913|144427781|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|1.01||||0.047||95.0|0.01|2.0|||Traditional Longitudinal data analysis|The model was adjusted by baseline 25-hydroxyvitamin D level stratum, age, and region.|FOSAVANCE minus Referred-Care. Analysis was for Lumbar Spine.|||2.00|0.01|0.047
72453021|NCT00692913|144427781|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|0.82||||0.035||95.0|0.06|1.58|||Traditional Longitudinal data analysis|The model was adjusted by baseline 25-hydroxyvitamin D level stratum, age, and region.|FOSAVANCE minus Referred-Care. Analysis was for Total Hip.|||1.58|0.06|0.035
72453022|NCT00692913|144427782|SUPERIORITY_OR_OTHER_LEGACY||Difference of falls (falls/patient-year)|0.03|STANDARD_ERROR_OF_MEAN|0.08||0.675||95.0|-0.12|0.19|||Zero-Inflated Poisson Regression|Adjusted by the terms for treatment, baseline 25(OH) D level stratum, age, and region and offset variable of log (total patient-years in the study).||||0.19|-0.12|0.675
72453023|NCT00692913|144427783|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Means|-8.35||||0.001||95.0|-13.19|-3.54|||Longitudinal Data Analysis Model|The model was adjusted by baseline 25-hydroxyvitamin D level stratum, age, and region.||||-3.54|-13.19|0.001
72453024|NCT00692913|144427784|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Mean|-8.07|||<|0.001||95.0|-11.94|-4.21|||Longitudinal Data Analysis Model|The model was adjusted by baseline 25-hydroxyvitamin D level stratum, age, and region.||||-4.21|-11.94|<0.001
72453025|NCT02866942|144427797|OTHER|||||||0.26|||||||McNemar|||||||0.26
72453026|NCT03614663|144427814|SUPERIORITY|||||||0.321|||||||MMRM - Mixed model for repeated measures|||||||0.321
72453027|NCT03614663|144427815|SUPERIORITY|||||||0.149|||||||MMRM - Mixed model for repeated measures|||||||0.149
72620131|NCT00382863|144771189|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
72453028|NCT03614663|144427816|SUPERIORITY|||||||0.607|||||||MMRM - Mixed model for repeated measures|||||||0.607
72453029|NCT03614663|144427817|SUPERIORITY|||||||0.426|||||||ANOVA|||||||0.426
72453030|NCT03614663|144427818|SUPERIORITY|||||||0.02|||||||MMRM - Mixed model for repeated measures|||||||0.02
72453031|NCT03614663|144427819|SUPERIORITY|||||||0.091|||||||MMRM - Mixed model for repeated measures|||||||0.091
72453032|NCT03614663|144427820|SUPERIORITY|||||||0.135|||||||MMRM - Mixed model for repeated measures|||||||0.135
72453033|NCT03614663|144427821|SUPERIORITY|||||||0.056|||||||MMRM - Mixed model for repeated measures|||||||0.056
72453034|NCT01128595|144427822|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.515|||||TWO_SIDED|95.0|0.33|0.701||||||||0.701|0.330|
72453035|NCT01128595|144427822|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.543|||||TWO_SIDED|95.0|0.355|0.73||||||||0.730|0.355|
72453036|NCT01128595|144427822|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.195|||||TWO_SIDED|95.0|0.001|0.388||||||||0.388|0.001|
72453037|NCT01128595|144427822|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.027|||||TWO_SIDED|95.0|-0.198|0.143||||||||0.143|-0.198|
72453038|NCT01128595|144427822|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.32|||||TWO_SIDED|95.0|0.14|0.501||||||||0.501|0.140|
72453039|NCT01128595|144427825|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.484|||||TWO_SIDED|95.0|0.332|0.636||||||||0.636|0.332|
72453040|NCT01128595|144427825|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.484|||||TWO_SIDED|95.0|0.33|0.638||||||||0.638|0.330|
72453041|NCT01128595|144427825|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.168|||||TWO_SIDED|95.0|0.009|0.327||||||||0.327|0.009|
72453042|NCT01128595|144427825|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|||||TWO_SIDED|95.0|-0.14|0.14||||||||0.140|-0.140|
72453043|NCT01128595|144427825|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.316|||||TWO_SIDED|95.0|0.168|0.464||||||||0.464|0.168|
72453044|NCT01128595|144427826|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.212|||||TWO_SIDED|95.0|0.031|0.393||||||||0.393|0.031|
72453045|NCT01128595|144427826|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.341|||||TWO_SIDED|95.0|0.147|0.536||||||||0.536|0.147|
72453046|NCT01128595|144427826|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.477|||||TWO_SIDED|95.0|0.282|0.672||||||||0.672|0.282|
72453047|NCT01128595|144427826|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.265|||||TWO_SIDED|95.0|0.066|0.463||||||||0.463|0.066|
72453048|NCT01128595|144427826|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.135|||||TWO_SIDED|95.0|-0.072|0.343||||||||0.343|-0.072|
72453049|NCT01128595|144427827|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.089|||||TWO_SIDED|95.0|-0.037|0.215||||||||0.215|-0.037|
72453050|NCT01128595|144427827|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.236|||||TWO_SIDED|95.0|0.101|0.371||||||||0.371|0.101|
72453051|NCT01128595|144427827|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.263|||||TWO_SIDED|95.0|0.127|0.398||||||||0.398|0.127|
72453052|NCT01128595|144427827|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.174|||||TWO_SIDED|95.0|0.036|0.312||||||||0.312|0.036|
72453053|NCT01128595|144427827|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.026|||||TWO_SIDED|95.0|-0.118|0.171||||||||0.171|-0.118|
72453054|NCT00372775|144427835|SUPERIORITY_OR_OTHER||Objective Response Rate (ORR) (percent)|1.6|||||TWO_SIDED|95.0|0.0|8.8|||||Two-Sided Confidence Interval (CI) from Exact Method using the F Distribution|||8.8|0.0|
72453055|NCT00372775|144427837|SUPERIORITY_OR_OTHER||ORR (percent)|4.3|||||TWO_SIDED|95.0|0.1|21.9|||||Two-Sided CI from Exact Method using the F Distribution|||21.9|0.1|
72453056|NCT00372775|144427840|SUPERIORITY_OR_OTHER||Percentage|23.4|||||TWO_SIDED|95.0|14.0|34.3|||||Probability of survival along with the corresponding 2-sided confidence interval for the log \[-log(one-year survival rate)\] calculated using a normal approximation and then back transformed to give a confidence interval for the one-year survival|||34.3|14.0|
72453057|NCT02568215|144427865|OTHER||Prevention Efficacy (PE)|8.8||||0.7|TWO_SIDED|95.0|-45.1|42.6||The threshold for statistical significance was p = 0.05.|wald|||The primary PE analysis tests the null hypothesis PE equal to zero versus the alternative hypothesis PE not equal to zero using a 2-sided alpha equal 0.05 level Wald test of the equality of log cumulative hazard functions at the week 80 visit for the pooled VRC01 group versus the placebo group.||42.6|-45.1|0.70
72453058|NCT02568215|144427865|OTHER||Prevention Efficacy (PE)|-9.3|||||TWO_SIDED|95.0|-85.3|35.5||||||A secondary analysis assesses the overall PE of the low-dose VRC01 group versus the placebo group.||35.5|-85.3|
72453059|NCT02568215|144427865|OTHER||Prevention Efficacy (PE)|27.0|||||TWO_SIDED|95.0|-30.7|59.3||||||A secondary analysis assesses the overall PE of the high-dose VRC01 group versus the placebo group.||59.3|-30.7|
72453060|NCT02568215|144427867|OTHER||Prevention Efficacy (PE)|78.6|||||TWO_SIDED|95.0|17.3|94.4||||||PE against IC80 of least sensitive variant less than 1||94.4|17.3|
72453061|NCT02568215|144427867|OTHER||Prevention Efficacy (PE)|7.4|||||TWO_SIDED|95.0|-187.5|70.2||||||PE against IC80 of least sensitive variant 1-3||70.2|-187.5|
72453062|NCT02568215|144427867|OTHER||Prevention Efficacy (PE)|-1.9|||||TWO_SIDED|95.0|-83.1|43.3||||||PE against IC80 of least sensitive variant \> 3||43.3|-83.1|
72453063|NCT00336505|144427869|NON_INFERIORITY_OR_EQUIVALENCE|Delta will be determined by the highest clinical cure-rate between the Cethromycin treatment group and the Clarithromycin treatment group, as follows: Greater than or equal to 90%, delta = -10%; Greater than or equal to 80% and less than 90%, delta = -15%, Greater than or equal to 70% and less than 80%, -20%)|Mean Difference (Net)|2.0||||0.5667|TWO_SIDED|95.0|-4.8|8.9|||Fisher Exact|||The rate of clinical cure in each treatment group was calculated (number of cures/number of patient eligible for analysis). Non-inferiority will be demonstrated when the lower limit of the two-sided 95% confidence interval for the difference in the clinical cure rate at the Test-of-Cure visit between treatment groups (Cethromycin -Clarithromycin) is greater than delta, and includes zero, for both Per-Protocol (PP) and Intent-to-Treat (ITT) analyses.||8.9|-4.8|0.5667
72469752|NCT01434680|144463238|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two-sided 95% CI for the ratio of the hSBA GMTs at 28 days following vaccination was within this equivalence interval for each of the two coprimary comparisons, MenC-CRM LIQ and MenC-CRM EMV would be declared equivalent with respect to the immune response to the vaccines.|hSBA GMT ratios|0.82|||<|0.05|TWO_SIDED|95.0|0.67|1.0|||ANOVA|95% CIs for the GMTs ratios was obtained by exponentiating difference of least square means of log10 transformed titers and both the limits of 95% CIs||The study would be considered a success if the two-sided 95% confidence intervals (CIs) for the hSBA GMT ratios comparing MenC-CRM LIQ to MenC-CRM EMV at 28 days after a single vaccination were both within the equivalence interval (0.5, 2.0).||1.00|0.67|<0.05
72453064|NCT00336505|144427871|NON_INFERIORITY_OR_EQUIVALENCE|Delta will be determined by the highest clinical cure-rate between the Cethromycin treatment group and the Clarithromycin treatment group, as follows: Greater than or equal to 90%, delta = -10%; Greater than or equal to 80% and less than 90%, delta = -15%, Greater than or equal to 70% and less than 80%, -20%)|Mean Difference (Net)|0.3|||>|0.9999||95.0|-4.5|5.1|||Fisher Exact|||The rate of clinical cure in each treatment group was calculated (number of cures/number of patient eligible for analysis). Non-inferiority will be demonstrated when the lower limit of the two-sided 95% confidence interval for the difference in the clinical cure rate at the Test-of-Cure visit between treatment groups (Cethromycin -Clarithromycin) is greater than delta, and includes zero, for both Per-Protocol (PP) and Intent-to-Treat (ITT) analyses.||5.1|-4.5|>0.9999
72453065|NCT01561300|144427873|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0||||0.09|TWO_SIDED|95.0|-2.16|0.17|||Mixed Models Analysis|Subject as random factor, baseline same period and mean baseline in both periods as covariates, and treatment, operator, and period as fixed effects.|Tea-placebo|Null hypothesis: no difference between Tea and Control.||0.17|-2.16|0.09
72453066|NCT01561300|144427874|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.39||||0.7|TWO_SIDED|95.0|-2.44|1.66|||Mixed Models Analysis|Subject as random factor, baseline same period and mean baseline in both periods as covariates, and treatment, operator, and period as fixed effects.|Tea- Control|Null hypothesis: no difference between Tea and Control.||1.66|-2.44|0.70
72453067|NCT01561300|144427875|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2||||0.66|TWO_SIDED|95.0|-1.15|0.75||Subject as random factor, baseline same period and mean baseline in both periods as covariates, and treatment, operator, and period as fixed effects.|Mixed Models Analysis||Tea-placebo|Null hypothesis: no difference between Tea and Control.||0.75|-1.15|0.66
72453068|NCT00246805|144427880|SUPERIORITY_OR_OTHER||Proportions|48.0|||<|0.0001|TWO_SIDED|95.0|36.0|61.0|||Z-test for proportions|||VRS ON vs. VRS OFF||61|36|<0.0001
72453069|NCT00724126|144427895|SUPERIORITY_OR_OTHER_LEGACY|||||||0.03|||||||Regression, Logistic|The p-value was obtained from a logistic regression model with fixed effects for treatment arm and analysis center.||||||0.03
72453070|NCT00724126|144427896|SUPERIORITY_OR_OTHER_LEGACY|||||||0.02|||||||Regression, Logistic|The p-value was obtained from a logistic regression model with fixed effects for treatment arm and analysis center.||||||0.02
72499447|NCT01431287|144529514|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.04|STANDARD_ERROR_OF_MEAN|0.012||0.0014|TWO_SIDED|95.0|0.015|0.064||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.064|0.015|0.0014
72499448|NCT01431287|144529515|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.088|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|0.063|0.113||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.113|0.063|<0.0001
72499449|NCT01431287|144529515|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.05|STANDARD_ERROR_OF_MEAN|0.013||0.0001|TWO_SIDED|95.0|0.024|0.075||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.075|0.024|0.0001
72499450|NCT01431287|144529515|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.067|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|0.042|0.092||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.092|0.042|<0.0001
72499451|NCT01431287|144529515|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.062|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|0.037|0.087||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.087|0.037|<0.0001
72499452|NCT01431287|144529515|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.029|STANDARD_ERROR_OF_MEAN|0.013||0.0231|TWO_SIDED|95.0|0.004|0.054||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.054|0.004|0.0231
72499453|NCT01431287|144529515|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.021|STANDARD_ERROR_OF_MEAN|0.013||0.1073|TWO_SIDED|95.0|-0.004|0.046||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.046|-0.004|0.1073
72453071|NCT02502526|144427900|SUPERIORITY||||||<|0.001|||||||ANCOVA|||||||<.001
72453072|NCT02502526|144427901|SUPERIORITY||||||<|0.001|||||||ANCOVA|||||||<.001
72453073|NCT02502526|144427901|SUPERIORITY|||||||0.605|||||||ANCOVA|||||||0.605
72453074|NCT02502526|144427902|SUPERIORITY|||||||0.52|||||||ANCOVA|||||||0.520
72453075|NCT02502526|144427902|SUPERIORITY|||||||0.817|||||||ANCOVA|||||||0.817
72453076|NCT01324310|144427930|SUPERIORITY_OR_OTHER_LEGACY||Ratio of Geometric Mean|124.4|||||TWO_SIDED|90.0|110.2|140.5|||ANOVA||"Geometric means ratio (Romidepsin + Ketoconazole/Romidepsin) and 90% CI of the ratio of geometric means are from an ANOVA model with treatment as fixed effect and subject as random effect on the natural log transformed PK values."|||140.5|110.2|
72453077|NCT01324310|144427931|SUPERIORITY_OR_OTHER_LEGACY||Ratio of the Geometric Mean|123.7|||||TWO_SIDED|90.0|109.6|139.6|||ANOVA|||||139.6|109.6|
72453078|NCT01324310|144427932|SUPERIORITY_OR_OTHER_LEGACY||Ratio of the Geometric Mean|124.6|||||TWO_SIDED|90.0|109.0|142.4|||ANOVA|||||142.4|109.0|
72453079|NCT01324310|144427933|SUPERIORITY_OR_OTHER_LEGACY||Ratio of the Geometric Mean|109.5|||||TWO_SIDED|90.0|94.9|126.4|||ANOVA|||||126.4|94.9|
72453080|NCT01324310|144427934|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|0.0||||0.7422|TWO_SIDED|90.0|-0.485|0.095|||Wilcoxon signed- rank|||"Note: The median, median difference (romidepsin + ketoconazole minus romidepsin) and 90% CI of the median difference are from Hodges-Lehmann Estimate. The P-value is from Wilcoxon signed-rank test."||0.095|-0.485|0.7422
72453081|NCT02029235|144427947|OTHER|||||||0.24|||||||t-test, 2 sided|||"Null hypothesis: No difference between groups~Power analysis: A sample size of 16 in each group had an 80% power to detect a difference in means of 10 mm."||||0.24
72453082|NCT02029235|144427948|OTHER|||||||0.06|||||||t-test, 2 sided|||Null hypothesis: No difference between groups||||0.06
72453083|NCT04066075|144427962|SUPERIORITY|||||||0.73||||||The p-value represents the difference between telerehabilitation and usual care.|Multilevel linear regression model|||Multilevel modeling in linear regression analyses accounted for within-patient correlations for the 3 assessments at baseline, 1-month and 4-months. Rasch analysis using the method of successive dichotomizations was applied to estimate person measures. Power calculation: a matched pairs t-test revealed 18 subjects per group would detect a within-subject mean improvement of 0.14-logits with 0.17-logits standard deviation for the differences, 0.80 power and 0.05 type 1 error probability.||||0.73
72453084|NCT04057820|144427981|SUPERIORITY||Incidence rate ratio (IRR)|0.55|||<|0.0001|TWO_SIDED|95.0|0.46|0.65|||Mixed Models Analysis|The model adjusted for study design (i.e., fixed time effect and random site effect) and randomization scheme stratification indicator.||||0.65|0.46|<0.0001
72453085|NCT04057820|144427982|SUPERIORITY||Risk Ratio (RR)|0.38|||<|0.0001|TWO_SIDED|95.0|0.3|0.47|||Mixed-effect Poisson w/ robust err var|The model adjusted for study design (i.e., fixed time effect and random site effect) and randomization scheme stratification indicator.||||0.47|0.30|<0.0001
72453086|NCT04057820|144427983|SUPERIORITY||Mean Difference (Final Values)|2.3|||||TWO_SIDED|95.0|-0.4|4.9||||||||4.9|-0.4|
72453087|NCT04057820|144427984|SUPERIORITY||Mean Difference (Final Values)|23.0|||||TWO_SIDED|95.0|8.1|37.9||||||||37.9|8.1|
72453088|NCT04057820|144427985|SUPERIORITY||Risk Ratio (RR)|0.81|||||TWO_SIDED|95.0|0.37|1.76||||||||1.76|0.37|
72453089|NCT04057820|144427986|SUPERIORITY||Mean Difference (Final Values)|0.4|||||TWO_SIDED|95.0|-0.3|1.0|||Mixed Models Analysis|||||1.0|-0.3|
72499454|NCT01431287|144529515|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.083|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|0.058|0.108||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.108|0.058|<0.0001
72453090|NCT04057820|144427987|SUPERIORITY||Risk Ratio (RR)|1.94|||||TWO_SIDED|95.0|0.94|3.99||||||||3.99|0.94|
72453091|NCT04057820|144427988|SUPERIORITY||Risk Ratio (RR)|1.68|||||TWO_SIDED|95.0|1.13|2.48||||||||2.48|1.13|
72453092|NCT04057820|144427989|SUPERIORITY||Incidence ratio ratio (IRR)|0.56|||||TWO_SIDED|95.0|0.49|0.64|||Mixed Models Analysis|The model adjusted for study design (i.e., fixed time effect and random site effect) and randomization scheme stratification indicator.||||0.64|0.49|
72453093|NCT04057820|144427991|SUPERIORITY||Risk Ratio (RR)|1.02|||||TWO_SIDED|95.0|0.71|1.47||||||||1.47|0.71|
72453094|NCT03516942|144428072|EQUIVALENCE|No margin of equivalence|Slope|0.0||||0.74|TWO_SIDED|95.0|-0.1|0.2||P value: For the categorical variable with more than 2 levels, this is the p value from the overall test of the null hypothesis that all estimates are equal against the alternative that at least one is different.|Regression, Linear|||"Age covariate effect on change in COST The linear (non-longitudinal) model of \[change in COST from baseline to 12-month follow-up\] included covariates for: age, Baseline COST score, cancer stage, cancer type, chemotherapy, comorbidities, education, FACT-G7, gender, income, marital status, insurance status, race, safety-net hospital, self-efficacy, NDI.~Null: All estimates are equal"||0.2|-0.1|0.74
72453095|NCT03516942|144428072|EQUIVALENCE|No margin of equivalence|Slope|-0.4|||<|0.001|TWO_SIDED|95.0|-0.6|-0.3||P value: For the categorical variable with more than 2 levels, this is the p value from the overall test of the null hypothesis that all estimates are equal against the alternative that at least one is different.|Regression, Linear|||"Baseline COST effect on change in COST The linear (non-longitudinal) model of \[change in COST from baseline to 12-month follow-up\] included covariates for: age, Baseline COST score, cancer stage, cancer type, chemotherapy, comorbidities, education, FACT-G7, gender, income, marital status, insurance status, race, safety-net hospital, self-efficacy, NDI.~Null: All estimates are equal"||-0.3|-0.6|<0.001
72453096|NCT03516942|144428072|EQUIVALENCE|No margin of equivalence||||||0.002||||||This is the p value of the null hypothesis that COST estimates for all cancer types (Colon cancer, Rectal cancer and Rectosigmoid) are equal against the alternative that at least one is different.|Regression, Linear|||"Cancer type (Colon cancer, Rectal cancer and Rectosigmoid) effect on change in COST The linear (non-longitudinal) model of \[change in COST from baseline to 12-month follow-up\] included covariates for: age, Baseline COST score, cancer stage, cancer type, chemotherapy, comorbidities, education, FACT-G7, gender, income, marital status, insurance status, race, safety-net hospital, self-efficacy, NDI.~Null: All estimates are equal"||||0.002
72453097|NCT03516942|144428072|EQUIVALENCE|No margin of equivalence|Slope|0.3||||0.03|TWO_SIDED|95.0|0.0|0.6|||Regression, Linear|||"FACT-G7 effect on change in COST The linear (non-longitudinal) model of \[change in COST from baseline to 12-month follow-up\] included covariates for: age, Baseline COST score, cancer stage, cancer type, chemotherapy, comorbidities, education, FACT-G7, gender, income, marital status, insurance status, race, safety-net hospital, self-efficacy, NDI.~Null: All estimates are equal"||0.6|0.0|0.03
72453098|NCT03516942|144428072|EQUIVALENCE|No margin of equivalence|Slope|1.6||||0.13|TWO_SIDED|95.0|-0.5|3.7|||Regression, Linear|||"Gender effect on change in COST The linear (non-longitudinal) model of \[change in COST from baseline to 12-month follow-up\] included covariates for: age, Baseline COST score, cancer stage, cancer type, chemotherapy, comorbidities, education, FACT-G7, gender, income, marital status, insurance status, race, safety-net hospital, self-efficacy, NDI.~Null: All estimates are equal"||3.7|-0.5|0.13
72620132|NCT00382863|144771190|SUPERIORITY_OR_OTHER|||||||0.032|||||||Wilcoxon (Mann-Whitney)|Two-sided||||||0.032
72453099|NCT03516942|144428072|EQUIVALENCE|No margin of equivalence||||||0.91||||||This is the p value of the null hypothesis that COST estimates for all RACES (White, Black, other) are equal against the alternative that at least one is different.|Regression, Linear|||"RACE (White. Black Other) effect on change in COST The linear (non-longitudinal) model of \[change in COST from baseline to 12-month follow-up\] included covariates for: age, Baseline COST score, cancer stage, cancer type, chemotherapy, comorbidities, education, FACT-G7, gender, income, marital status, insurance status, race, safety-net hospital, self-efficacy, NDI.~Null: All estimates are equal"||||0.91
72453100|NCT03516942|144428072|EQUIVALENCE|No margin of equivalence|Slope|0.0|||>|0.99|TWO_SIDED|95.0|-0.3|0.3|||Regression, Linear|||"Neighborhood Deprivation (NDI) effect on change in COST The linear (non-longitudinal) model of \[change in COST from baseline to 12-month follow-up\] included covariates for: age, Baseline COST score, cancer stage, cancer type, chemotherapy, comorbidities, education, FACT-G7, gender, income, marital status, insurance status, race, safety-net hospital, self-efficacy, NDI.~Higher NDI = greater neighborhood deprivation"||0.3|-0.3|>0.99
72453101|NCT03516942|144428074|EQUIVALENCE|no margin||||||0.4142||||||alpha=0.05|McNemar|||Work Time Missed from Baseline to 6 Months||||0.4142
72453102|NCT03516942|144428074|EQUIVALENCE|no margin||||||0.1797|||||||McNemar|||Impairment of Activities at Work from Baseline to 6 Months||||0.1797
72453103|NCT03516942|144428074|EQUIVALENCE|no margin||||||0.8415|||||||McNemar|||Overall Work Impairment from Baseline to 6 Months||||0.8415
72453104|NCT03516942|144428074|EQUIVALENCE|no margin||||||0.6831|||||||McNemar|||Impairment of Activities Outside of Work from Baseline to 6 Months||||0.6831
72453105|NCT03516942|144428074|EQUIVALENCE|no margin|||||<|0.0001|||||||McNemar|||Work Time Missed from Baseline to 12 Months||||<.0001
72453106|NCT03516942|144428074|EQUIVALENCE|no margin||||||0.0455|||||||McNemar|||Impairment of Activities at Work from Baseline to 12 Months||||0.0455
72453107|NCT03516942|144428074|EQUIVALENCE|no margin|||||<|0.0001|||||||McNemar|||Overall Work Impairment from Baseline to 12 Months||||<.0001
72453108|NCT03516942|144428074|EQUIVALENCE|no margin||||||0.0164|||||||McNemar|||3 Impairment of Activities Outside of Work from Baseline to 12 Months||||0.0164
72453109|NCT03516942|144428074|EQUIVALENCE|nomargin||||||0.0027|||||||McNemar|||Work Time Missed from Baseline to 24 Months||||0.0027
72499455|NCT01431287|144529515|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.038|STANDARD_ERROR_OF_MEAN|0.013||0.0029|TWO_SIDED|95.0|0.013|0.063||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.063|0.013|0.0029
72499456|NCT01431287|144529515|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.005|STANDARD_ERROR_OF_MEAN|0.013||0.6939|TWO_SIDED|95.0|-0.02|0.03||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.030|-0.020|0.6939
72499457|NCT01431287|144529515|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.033|STANDARD_ERROR_OF_MEAN|0.013||0.0097|TWO_SIDED|95.0|0.008|0.058||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.058|0.008|0.0097
72453110|NCT03516942|144428074|EQUIVALENCE|no margin||||||0.0124|||||||McNemar|||Impairment of Activities at Work from Baseline to 24 Months||||0.0124
72453111|NCT03516942|144428074|EQUIVALENCE|no margin|||||<|0.0001|||||||McNemar|||Overall Work Impairment from Baseline to 24 Months||||<.0001
72499458|NCT01431287|144529516|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.693|STANDARD_ERROR_OF_MEAN|0.553||0.0022|TWO_SIDED|95.0|-2.778|-0.608||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||-0.608|-2.778|0.0022
72620133|NCT00382863|144771191|SUPERIORITY_OR_OTHER|||||||0.54|||||||Fisher Exact|One-sided||Improvement of at least 1.0 ml/kg/min from baseline.||||0.540
72620134|NCT00382863|144771192|SUPERIORITY_OR_OTHER|||||||0.067|||||||Fisher Exact|One-sided||Improvement of at least 45 m from baseline.||||0.067
72453112|NCT03516942|144428074|EQUIVALENCE|no margin||||||0.0011|||||||McNemar|||Impairment of Activities Outside of Work from Baseline to 24 Months||||0.0011
72453113|NCT03516942|144428080|EQUIVALENCE|no equivalence margin was assumed||||||0.017|||||||McNemar|||the McNemar test was used to compare the results assuming a null of no difference.||||0.017
72453114|NCT00712179|144428083|SUPERIORITY_OR_OTHER|||||||0.981|||||||Mixed Models Analysis|||Null Hypothesis: Walking at different speeds with 15% body weight support will have no effect on EMG pattern.||||0.981
72453115|NCT00712179|144428083|SUPERIORITY_OR_OTHER|||||||0.84|||||||Mixed Models Analysis|||Null Hypothesis: Walking at self selected speed at 0%, 15% and 30% of body weight support will have no effect on EMG pattern||||0.84
72453116|NCT00712179|144428083|SUPERIORITY_OR_OTHER|||||||0.16|||||||Mixed Models Analysis|||Null Hypothesis: Walking at different speeds with 30% body weight support will have no effect on EMG pattern.||||0.16
72453117|NCT00712179|144428083|SUPERIORITY_OR_OTHER|||||||0.073|||||||Mixed Models Analysis|||Null Hypothesis: Walking at fastest comfortable speeds with different amount of body weight supports will not affect the EMG pattern.||||0.073
72453118|NCT00712179|144428083|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Mixed Models Analysis|||Null Hypothesis: Modification of non-paretic leg loading and movement by the therapist will have no effect on EMG pattern of paretic leg.||||<0.001
72453119|NCT00712179|144428083|SUPERIORITY_OR_OTHER|||||||0.94|||||||Mixed Models Analysis|||Null Hypothesis: Modification of paretic leg loading and movement by the therapist will have significant effect on EMG pattern of non-paretic leg.||||0.94
72453120|NCT00065182|144428095|SUPERIORITY||Hazard Ratio (HR)|1.007||||0.946|TWO_SIDED|95.0|0.813|1.248|||Log Rank||Unadjusted hazard ratio.|||1.248|0.813|0.9460
72453121|NCT00065182|144428095|SUPERIORITY||Hazard Ratio (HR)|0.977|||||TWO_SIDED|95.0|0.788|1.21|||||Adjusted hazard ratio.|||1.210|0.788|
72453122|NCT03801148|144428121|EQUIVALENCE|Natural log (ln)-transformed-Cmax, was analyzed using an analysis of variance (ANOVA) model to assess the relative bioavailability of dexlansoprazole 30 mg capsule manufactured at TOB compared with dexlansoprazole 30 mg capsule manufactured at TPC. Geometric least square mean (LSM) ratios were calculated using the exponentiation of the difference between treatment LSM from the analyses on the ln-transformed Cmax.|Geometric LSM ratio|0.98|||||TWO_SIDED|90.0|0.9171|1.0473||||||||1.0473|0.9171|
72453123|NCT03801148|144428121|EQUIVALENCE|ln-transformed-Cmax, was analyzed using an ANOVA model to assess the relative bioavailability of dexlansoprazole 60 mg capsule manufactured at TOB compared with dexlansoprazole 60 mg capsule manufactured at TPC. Geometric LSM ratios were calculated using the exponentiation of the difference between treatment LSM from the analyses on the ln-transformed Cmax.|Geometric LSM ratio|1.0737|||||TWO_SIDED|90.0|1.0025|1.1501||||||||1.1501|1.0025|
72453124|NCT03801148|144428122|EQUIVALENCE|ln-transformed- AUClast, was analyzed using an ANOVA model to assess the relative bioavailability of dexlansoprazole 30 mg capsule manufactured at TOB compared with dexlansoprazole 30 mg capsule manufactured at TPC. Geometric LSM ratios were calculated using the exponentiation of the difference between treatment LSM from the analyses on the ln-transformed AUClast.|Geometric LSM ratio|1.0455|||||TWO_SIDED|90.0|1.007|1.0855||||||||1.0855|1.0070|
72453125|NCT03801148|144428122|EQUIVALENCE|ln-transformed- AUClast, was analyzed using an ANOVA model to assess the relative bioavailability of dexlansoprazole 60 mg capsule manufactured at TOB compared with dexlansoprazole 60 mg capsule manufactured at TPC. Geometric LSM ratios were calculated using the exponentiation of the difference between treatment LSM from the analyses on the ln-transformed AUClast.|Geometric LSM ratio|1.061|||||TWO_SIDED|90.0|1.0192|1.1046||||||||1.1046|1.0192|
72453126|NCT03801148|144428123|EQUIVALENCE|ln-transformed- AUC0\_infobs, was analyzed using an ANOVA model to assess the relative bioavailability of dexlansoprazole 30 mg capsule manufactured at TOB compared with dexlansoprazole 30 mg capsule manufactured at TPC. Geometric LSM ratios were calculated using the exponentiation of the difference between treatment LSM from the analyses on the ln-transformed AUC0\_infobs.|Geometric LSM ratio|1.0553|||||TWO_SIDED|90.0|1.0186|1.0933||||||||1.0933|1.0186|
72453127|NCT03801148|144428123|EQUIVALENCE|ln-transformed- AUC0\_infobs, was analyzed using an ANOVA model to assess the relative bioavailability of dexlansoprazole 60 mg capsule manufactured at TOB compared with dexlansoprazole 60 mg capsule manufactured at TPC. Geometric LSM ratios were calculated using the exponentiation of the difference between treatment LSM from the analyses on the ln-transformed AUC0\_infobs.|GMR|1.0468|||||TWO_SIDED|90.0|1.0027|1.0929||||||||1.0929|1.0027|
72453128|NCT03801148|144428124|EQUIVALENCE|ln-transformed- AUC0\_infpred, was analyzed using an ANOVA model to assess the relative bioavailability of dexlansoprazole 30 mg capsule manufactured at TOB compared with dexlansoprazole 30 mg capsule manufactured at TPC. Geometric LSM ratios were calculated using the exponentiation of the difference between treatment LSM from the analyses on the ln-transformed AUC0\_infpred.|Geometric LSM ratio|1.0555|||||TWO_SIDED|90.0|1.0188|1.0935||||||||1.0935|1.0188|
72453129|NCT03801148|144428124|EQUIVALENCE|ln-transformed- AUC0\_infpred, was analyzed using an ANOVA model to assess the relative bioavailability of dexlansoprazole 60 mg capsule manufactured at TOB compared with dexlansoprazole 60 mg capsule manufactured at TPC. Geometric LSM ratios were calculated using the exponentiation of the difference between treatment LSM from the analyses on the ln-transformed AUC0\_infpred.|Geometric LSM ratio|1.0472|||||TWO_SIDED|90.0|1.0029|1.0934||||||||1.0934|1.0029|
72453130|NCT00366249|144428164|NON_INFERIORITY_OR_EQUIVALENCE|Statistical analysis tested for non-inferiority. Non-inferiority margin is -10%.|Mehrotra and Railker|-5.5||||||95.0|-11.0|0.1|||||Adjusted for Perfusion, Extent, Depth/tissue loss, Infection, and Sensation (PEDIS) score|Analysis provided for Cure||0.1|-11.0|
72453131|NCT00366249|144428166|NON_INFERIORITY_OR_EQUIVALENCE|Statistical analysis tested for non-inferiority. Non-inferiority margin is -10%.|Mehrotra and Railkar|-6.7||||||95.0|-12.3|-1.1|||||Adjusted for PEDIS score|Analysis provided for Cure||-1.1|-12.3|
72453132|NCT00366249|144428168|NON_INFERIORITY_OR_EQUIVALENCE|Statistical analysis tested for non-inferiority. Non-inferiority margin is -10%.|Mehrotra and Railkar|-6.3||||||95.0|-13.6|1.0|||||Adjusted for PEDIS score|||1.0|-13.6|
72453133|NCT01185600|144428170|SUPERIORITY_OR_OTHER|||||||0.142|||||||Fisher Exact|||||||0.142
72453134|NCT01185600|144428171|SUPERIORITY_OR_OTHER|||||||0.0391|||||||Fisher Exact|||||||0.0391
72453135|NCT01185600|144428172|SUPERIORITY_OR_OTHER|||||||0.372|||||||Fisher Exact|||||||0.372
72453136|NCT01185600|144428173|SUPERIORITY_OR_OTHER|||||||0.1007|||||||t-test, 2 sided|||||||0.1007
72453137|NCT01185600|144428174|SUPERIORITY_OR_OTHER|||||||0.0964|||||||t-test, 2 sided|||||||0.0964
72453138|NCT01185600|144428175|SUPERIORITY_OR_OTHER|||||||0.1739|||||||t-test, 2 sided|||||||0.1739
72453139|NCT01185600|144428176|SUPERIORITY_OR_OTHER|||||||0.7205|||||||t-test, 1 sided|||||||0.7205
72453140|NCT01185600|144428177|SUPERIORITY_OR_OTHER||Negative Binomial|1.64||||0.0176|TWO_SIDED|95.0|1.06|2.55|||t-test, 2 sided||"Using Negative Binomial Regression the following ratio and corresponding 95% CI were obtained:~(# of AE's, Unwashed Group / (# of AE's, Washed Group) = 1.64 95% C.I. = \[1.06 - 2.55\]"|||2.55|1.06|0.0176
72453141|NCT03577106|144428194|OTHER||||||<|0.005||||||t(20)=3.3, p\<0.005|paired t-test|||Mean difference using a paired t-test||||<0.005
72453142|NCT01500200|144428202|SUPERIORITY|||||||0.014||||||Hypothesis tests were two-sided with an alpha of 0.5.|Mixed Models Analysis|ALKS 5461 was compared to PBO using stage-specific MMRM for change from Baseline. Model-derived estimates were combined using pre-specified weights.||Analysis was conducted for each stage separately and overall efficacy was based on combined stage analysis where stage-specific estimates were combined using pre-specified weights (0.6/0.4 for Stage 1/Stage 2). Within each stage ALKS 5461 2mg/2mg was compared to placebo (i.e., ALKS 5461 2mg/2mg S1 vs Placebo S1; and ALKS 5461 2mg/2mg S2 vs Placebo S2.||||0.014
72620135|NCT00382863|144771193|SUPERIORITY_OR_OTHER|||||||0.031|||||||Fisher Exact|One-sided||Improvement of at least 7 points from baseline.||||0.031
72620136|NCT00382863|144771194|SUPERIORITY_OR_OTHER|||||||0.109|||||||Log Rank|||Kaplan-Meier actuarial time-to-first-event analysis||||0.109
72453143|NCT01500200|144428202|SUPERIORITY|||||||0.699||||||Hypothesis tests were two-sided with an alpha of 0.05.|Mixed Models Analysis|ALKS 5461 was compared to PBO using stage-specific MMRM for change from Baseline. Model-derived estimates were combined using pre-specified weights.||Analysis was conducted for each stage separately and overall efficacy was based on combined stage analysis where stage-specific estimates were combined using pre-specified weights (0.6/0.4 for Stage 1/Stage 2). Within each stage ALKS 5461 8mg/8mg was compared to placebo (i.e., ALKS 5461 8mg/8mg S1 vs Placebo S1; and ALKS 5461 8mg/8mg S2 vs Placebo S2.||||0.699
72562263|NCT00407745|144655841|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.76|STANDARD_ERROR_OF_MEAN|0.393||0.0538|TWO_SIDED|95.0|-1.54|0.01||Significance was declared if p-value \<=0.05|ANCOVA|ANCOVA model included terms of baseline NPSI - Individual Item Score as covariate and pooled center and treatment as fixed (class) cofactors.||"Item 3 - Pain like pressure~Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group."||0.01|-1.54|0.0538
72562264|NCT00407745|144655841|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.38|STANDARD_ERROR_OF_MEAN|0.389||0.3239|TWO_SIDED|95.0|-1.15|0.38||Significance was declared if p-value \<=0.05|ANCOVA|ANCOVA model included terms of baseline NPSI - Individual Item Score as covariate and pooled center and treatment as fixed (class) cofactors.||"Item 5 - Electric shocks~Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group."||0.38|-1.15|0.3239
72562265|NCT00407745|144655841|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.49|STANDARD_ERROR_OF_MEAN|0.376||0.1912|TWO_SIDED|95.0|-1.23|0.25||Significance was declared if p-value \<=0.05|ANCOVA|ANCOVA model included terms of baseline NPSI - Individual Item Score as covariate and pooled center and treatment as fixed (class) cofactors.||"Item 6 - Stabbing pain~Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group."||0.25|-1.23|0.1912
72562266|NCT00407745|144655841|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.15|STANDARD_ERROR_OF_MEAN|0.353||0.672|TWO_SIDED|95.0|-0.55|0.85||Significance was declared if p-value \<=0.05|ANCOVA|ANCOVA model included terms of baseline NPSI - Individual Item Score as covariate and pooled center and treatment as fixed (class) cofactors.||"Item 8 - By light touching~Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group."||0.85|-0.55|0.6720
72562267|NCT00407745|144655841|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.09|STANDARD_ERROR_OF_MEAN|0.33||0.7821|TWO_SIDED|95.0|-0.74|0.56||Significance was declared if p-value \<=0.05|ANCOVA|ANCOVA model included terms of baseline NPSI - Individual Item Score as covariate and pooled center and treatment as fixed (class) cofactors.||"Item 9 - By pressure~Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group."||0.56|-0.74|0.7821
72562268|NCT00407745|144655841|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.14|STANDARD_ERROR_OF_MEAN|0.352||0.6851|TWO_SIDED|95.0|-0.84|0.55||Significance was declared if p-value \<=0.05|ANCOVA|ANCOVA model included terms of baseline NPSI - Individual Item Score as covariate and pooled center and treatment as fixed (class) cofactors.||"Item 10 - By something cold~Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group."||0.55|-0.84|0.6851
72562269|NCT00407745|144655841|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.35|STANDARD_ERROR_OF_MEAN|0.387||0.361|TWO_SIDED|95.0|-1.12|0.41||Significance was declared if p-value \<=0.05|ANCOVA|ANCOVA model included terms of baseline NPSI - Individual Item Score as covariate and pooled center and treatment as fixed (class) cofactors.||"Item 11 - Pins and needles~Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group."||0.41|-1.12|0.3610
72562270|NCT00407745|144655841|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.28|STANDARD_ERROR_OF_MEAN|0.402||0.4915|TWO_SIDED|95.0|-1.07|0.52||Significance was declared if p-value \<=0.05|ANCOVA|ANCOVA model included terms of baseline NPSI - Individual Item Score as covariate and pooled center and treatment as fixed (class) cofactors.||"Item 12 - Tingling~Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group."||0.52|-1.07|0.4915
72562271|NCT00407745|144655842|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0536||95.0||||p-values are adjusted for baseline score. Significance was declared if p-value \<=0.05.|Cochran-Mantel-Haenszel|||Null hypothesis - The rate of subjects with improvement for the pregabain group was equal to the rate of subjects with improvement for the placebo group; Alternative hypothesis - The rate of subjects with improvement for the pregabain group was not equal to the rate of subjects with improvement for the placebo group.||||0.0536
72620137|NCT00382863|144771195|SUPERIORITY_OR_OTHER|||||||0.031|||||||Wilcoxon (Mann-Whitney)|Two-sided||||||0.031
72620138|NCT00382863|144771196|SUPERIORITY_OR_OTHER|||||||0.179|||||||Wilcoxon (Mann-Whitney)|Two-sided||||||0.179
72620139|NCT00382863|144771197|SUPERIORITY_OR_OTHER|||||||0.07|||||||Wilcoxon (Mann-Whitney)|Two-sided||||||0.070
72620140|NCT00382863|144771198|SUPERIORITY_OR_OTHER|||||||0.015|||||||Wilcoxon (Mann-Whitney)|Two-sided||||||0.015
72620141|NCT00382863|144771199|SUPERIORITY_OR_OTHER|||||||0.032|||||||Wilcoxon (Mann-Whitney)|Two-sided||||||0.032
72453144|NCT03066609|144428214|SUPERIORITY||Odds Ratio (OR)|153.94|||<|0.0001|TWO_SIDED|95.0|54.02|438.67|||Regression, Logistic|||PASI 75||438.67|54.02|<0.0001
72620142|NCT00382863|144771201|SUPERIORITY_OR_OTHER|||||||0.627|||||||Fisher Exact|Two-sided||||||0.627
72620143|NCT00382863|144771202|SUPERIORITY_OR_OTHER|||||||0.386|||||||Log Rank|||||||0.386
72620144|NCT00382863|144771203|SUPERIORITY_OR_OTHER|||||||0.154|||||||Fisher Exact|Two-sided||||||0.154
72620145|NCT00382863|144771204|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|Two-sided||||||1.000
72620146|NCT00382863|144771205|SUPERIORITY_OR_OTHER|||||||0.939|||||||Log Rank|||||||0.939
72620147|NCT00382863|144771206|SUPERIORITY_OR_OTHER|||||||0.012|||||||Fisher Exact|Two-sided||||||0.012
72620148|NCT00382863|144771207|SUPERIORITY_OR_OTHER|||||||0.001|||||||Log Rank|||||||0.001
72620149|NCT00382863|144771208|SUPERIORITY_OR_OTHER|||||||0.772|||||||Wilcoxon (Mann-Whitney)|Two-sided||||||0.772
72453145|NCT03066609|144428214|SUPERIORITY||Odds Ratio (OR)|557.98|||<|0.0001|TWO_SIDED|95.0|187.2|1663.4|||Regression, Logistic|||PASI 75||1663.4|187.2|<0.0001
72453146|NCT03066609|144428215|SUPERIORITY||Odds Ratio (OR)|75.82|||<|0.0001|TWO_SIDED|95.0|25.81|222.72|||Regression, Logistic|||IGA||222.72|25.81|<0.0001
72453147|NCT03066609|144428215|SUPERIORITY||Odds Ratio (OR)|149.71|||<|0.0001|TWO_SIDED|95.0|51.83|432.42|||Regression, Logistic|||IGA||432.42|51.83|<0.0001
72453148|NCT03066609|144428216|SUPERIORITY||Odds Ratio (OR)|114.85|||<|0.0001|TWO_SIDED|95.0|26.94|489.59|||Regression, Logistic|||PASI 90||489.59|26.94|<0.0001
72453149|NCT03066609|144428216|SUPERIORITY||Odds Ratio (OR)|246.12|||<|0.0001|TWO_SIDED|95.0|58.41|1037.1|||Regression, Logistic|||PASI 90||1037.1|58.41|<0.0001
72453150|NCT03170882|144428248|SUPERIORITY||Hazard Ratio (HR)|0.847|||=|0.477|TWO_SIDED|95.0|0.535|1.341|||Log Rank||HR obtained by unadjusted Cox's proportional hazard regression model stratified by age,international staging system(ISS),prior lines of therapy. HR\<1 was deemed to indicate better PFS in Ixazomib+Dexamethasone arm over Pomalidomide+Dexamethasone arm.|||1.341|0.535|=0.477
72453151|NCT03170882|144428249|SUPERIORITY||Hazard Ratio (HR)|1.427|||=|0.265|TWO_SIDED|95.0|0.761|2.677|||Log Rank||HR obtained by unadjusted Cox's proportional hazard regression model stratified by age, ISS and prior lines of therapy. HR \<1 was deemed to indicate longer survival time in Ixazomib + Dexamethasone arm as compared to Pomalidomide + Dexamethasone arm.|||2.677|0.761|=0.265
72499459|NCT01431287|144529516|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.233|STANDARD_ERROR_OF_MEAN|0.551||0.0252|TWO_SIDED|95.0|-2.313|-0.153||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||-0.153|-2.313|0.0252
72499460|NCT01431287|144529516|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.031|STANDARD_ERROR_OF_MEAN|0.552||0.062|TWO_SIDED|95.0|-2.113|0.052||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.052|-2.113|0.0620
72453152|NCT03170882|144428250|SUPERIORITY||Odds Ratio (OR)|0.9|||=|0.634|TWO_SIDED|95.0|0.43|1.9|||Cochran-Mantel-Haenszel||OR was based on logistic regression model with treatment group as categorical predictor variable and age, ISS and prior lines of therapy. OR \>1 was deemed to indicate better response in Ixazomib+Dexamethasone arm over Pomalidomide+Dexamethasone arm.|||1.90|0.43|=0.634
72453153|NCT03170882|144428252|SUPERIORITY||Hazard Ratio (HR)|0.556|||||TWO_SIDED|95.0|0.288|1.073|||||HR was obtained by unadjusted Cox's proportional hazard regression model stratified by age, ISS, prior lines of therapy. HR \>1 was deemed to indicate quicker response time in Ixazomib + Dexamethasone arm over Pomalidomide + Dexamethasone arm.|||1.073|0.288|
72453154|NCT03170882|144428253|SUPERIORITY||Hazard Ratio (HR)|0.83|||=|0.459|TWO_SIDED|95.0|0.506|1.361|||Log Rank||HR: obtained by unadjusted Cox's proportional hazard regression model stratified by age,ISS,prior lines of therapy. HR\<1 was deemed to indicate better disease progression prevention in Ixazomib+Dexamethasone arm over Pomalidomide+Dexamethasone arm.|||1.361|0.506|=0.459
72453155|NCT00622700|144428261|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.574||||0.0087|TWO_SIDED|95.0|0.379|0.869||P value was derived using Wald chi-squared test in the Cox proportional hazard model.|Wald chi-squared|||A step-down hierarchical testing procedure, starting with the test of teriflunomide 14 mg versus placebo was used. Time to conversion to CDMS was analyzed using the Cox proportional hazard model with treatment, region, and baseline monofocal/multifocal status as covariates.||0.869|0.379|0.0087
72453156|NCT00622700|144428261|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.628||||0.0271|TWO_SIDED|95.0|0.416|0.949||P value was derived using Wald chi-squared test in the Cox proportional hazard model.|Wald chi-squared|||A step-down hierarchical testing procedure was used. The second step was the test of teriflunomide 7 mg versus placebo for time to conversion to CDMS. Time to conversion to CDMS was analyzed using the Cox proportional hazard model with treatment, region, and baseline monofocal/multifocal status as covariates.||0.949|0.416|0.0271
72453157|NCT00622700|144428262|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.651||||0.0003|TWO_SIDED|95.0|0.515|0.822||P value was derived using Wald chi-squared test in the Cox proportional hazard model.|Wald chi-squared|||A step-down hierarchical testing procedure was used. The third step was the test of teriflunomide 14 mg versus placebo for time to conversion to DMS. This was analyzed using the Cox proportional hazard model with treatment, region, and baseline monofocal/multifocal status as covariates.||0.822|0.515|0.0003
72453158|NCT00622700|144428262|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.686||||0.002|TWO_SIDED|95.0|0.54|0.871||P value was derived using Wald chi-squared test in the Cox proportional hazard model.|Wald chi-squared|||A step-down hierarchical testing procedure was used. The fourth step was the test of teriflunomide 7 mg versus placebo for time to conversion to DMS. This was analyzed using the Cox proportional hazard model with treatment, region, and baseline monofocal/multifocal status as covariates.||0.871|0.540|0.0020
72453159|NCT02646618|144428278|NON_INFERIORITY|We set δ=2% as a relative margin to the 5% weight loss as clinically meaningful cut point and because 2% is not so small a difference in average weight loss between study conditions that we would have to recruit a prohibitively large sample.|Mean Difference (Net)|2.0||||0.0038|TWO_SIDED|95.0|0.6|3.3|||Mixed Models Analysis|||||3.3|0.6|0.0038
72453160|NCT02646618|144428279|NON_INFERIORITY|We set δ=2% as a relative margin to the 5% weight loss as clinically meaningful cut point and because 2% is not so small a difference in average weight loss between study conditions that we would have to recruit a prohibitively large sample.|Mean Difference (Net)|1.2||||0.1485|TWO_SIDED|95.0|-0.4|2.8|||Mixed Models Analysis|||||2.8|-0.4|0.1485
72562272|NCT00407745|144655843|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3107||95.0||||p-values are adjusted for baseline score. Significance was declared if p-value \<=0.05.|Cochran-Mantel-Haenszel|||Null hypothesis - The rate of subjects with improvement for the pregabain group was equal to the rate of subjects with improvement for the placebo group; Alternative hypothesis - The rate of subjects with improvement for the pregabain group was not equal to the rate of subjects with improvement for the placebo group.||||0.3107
72620150|NCT02837952|144771228|SUPERIORITY||Least Square Mean Difference|72.89|||<|0.001|TWO_SIDED|95.0|50.075|95.707|||ANCOVA|||Treatment difference and 95 percent (%) confidence interval (CI) were based on LS Mean from analysis of covariance (ANCOVA) with treatment, gender, baseline categorical pain severity rating (PSR) as classification variables and baseline numerical PSR used as a continuous covariate.||95.707|50.075|<0.001
72453161|NCT02646618|144428281|SUPERIORITY|||||||0.248|||||||t-test, 2 sided|||||||0.2480
72453162|NCT02646618|144428286|NON_INFERIORITY|For secondary noninferiority outcomes, we used 90% power to calculate noninferiority margins given N=131 per arm, setting alpha=.05 and using observed SDs from the literature. For change in energy (kcal/day) intake, the study is powered at 90% to detect whether the Get Social condition is not inferior to the Traditional condition with a noninferiority margin of 182 kcal/day (SD=500 kcal/day)|Mean Difference (Net)|93.0||||0.2025|TWO_SIDED|95.0|-50.0|237.0|||Mixed Models Analysis|||||237|-50|0.2025
72453163|NCT02646618|144428287|NON_INFERIORITY|For secondary noninferiority outcomes, we used 90% power to calculate noninferiority margins given N=131 per arm, setting alpha=.05 and using observed SDs from the literature. For change in energy (kcal/day) intake, the study is powered at 90% to detect whether the Get Social condition is not inferior to the Traditional condition with a noninferiority margin of 182 kcal/day (SD=500 kcal/day)|Mean Difference (Net)|-75.0||||0.3323|TWO_SIDED|95.0|-226.0|77.0|||Mixed Models Analysis|||||77|-226|0.3323
72453164|NCT02646618|144428289|NON_INFERIORITY|For secondary noninferiority outcomes, we used 90% power to calculate noninferiority margins given N=131 per arm, setting alpha=.05 and using observed SDs from the literature. For change in moderate to vigorous intensity physical activity minutes per day at 12 months, the noninferiority margin is 9.2 min/day(SD=25 min/day). However, we could not analyze the data in that manner and used the test described above.||||||0.3905|||||||Generalized estimating equation|||We examined the proportion of participants engaging in 150+ minutes/week of moderate/vigorous intensity physical activity (MVPA) using generalized estimating equations with a logit link function and incorporating repeated measures over time. For participants missing MVPA at either follow-up timepoint, we used a baseline observation carried forward approach to impute their activity level (150+ vs \<150 MVPA mins/week) at that timepoint.||||0.3905
72453165|NCT02646618|144428290|NON_INFERIORITY|For secondary noninferiority outcomes, we used 90% power to calculate noninferiority margins given N=131 per arm, setting alpha=.05 and using observed SDs from the literature. For change in moderate to vigorous intensity physical activity minutes per day at 12 months, the noninferiority margin is 9.2 min/day(SD=25 min/day). However, we could not analyze the data in that manner and used the test described above.||||||0.4741|||||||Generalized estimating equation|||We examined the proportion of participants engaging in 150+ minutes/week of moderate/vigorous intensity physical activity (MVPA) using generalized estimating equations with a logit link function and incorporating repeated measures over time. For participants missing MVPA at either follow-up timepoint, we used a baseline observation carried forward approach to impute their activity level (150+ vs \<150 MVPA mins/week) at that timepoint.||||0.4741
72453166|NCT02415127|144428339|SUPERIORITY|||||||0.5442||||||From a repeated-measures ANCOVA with fixed effects of treatment, visit, and treatment\*visit with baseline score and investigative site as covariates using an unstructured covariance matrix, testing ACTIMMUNE® vs placebo.|ANCOVA|||The primary and secondary efficacy endpoints were tested in a hierarchical manner. Each endpoint was tested in sequential order and the current endpoint must have shown statistical significance (p \< 0.05) prior to performing testing the next endpoint. The primary endpoint, FARS-mNeuro, was to be tested first, followed by the key secondary endpoint, ADL, followed by the other secondary endpoints, T25FW, FARS-mNeuro responder rate, and FARStot.||||0.5442
72499461|NCT01431287|144529516|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.456|STANDARD_ERROR_OF_MEAN|0.548||0.4051|TWO_SIDED|95.0|-1.531|0.618||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.618|-1.531|0.4051
72453167|NCT01855750|144428350|SUPERIORITY||Hazard Ratio (HR)|0.922||||0.5167|TWO_SIDED|95.0|0.72|1.18|||Log Rank|||||1.180|0.720|0.5167
72453168|NCT01855750|144428351|SUPERIORITY||Hazard Ratio (HR)|0.949||||0.7311|TWO_SIDED|95.0|0.704|1.279|||Log Rank|||||1.279|0.704|0.7311
72453169|NCT01855750|144428352|SUPERIORITY||Hazard Ratio (HR)|0.917||||0.5027|TWO_SIDED|95.0|0.71|1.183|||Log Rank|||||1.183|0.710|0.5027
72453170|NCT01855750|144428353|SUPERIORITY||Odds Ratio (OR)|0.967||||0.8229|TWO_SIDED|95.0|0.722|1.296|||Cochran-Mantel-Haenszel (CMH) Chi-square|||||1.296|0.722|0.8229
72453171|NCT01855750|144428354|SUPERIORITY||Hazard Ratio (HR)|1.03||||0.8549|TWO_SIDED|95.0|0.754|1.407|||Log Rank|||||1.407|0.754|0.8549
72453172|NCT01855750|144428355|SUPERIORITY||Hazard Ratio (HR)|1.358||||0.0021|TWO_SIDED|95.0|1.115|1.654|||Log Rank|||||1.654|1.115|0.0021
72499462|NCT01431287|144529516|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.571|STANDARD_ERROR_OF_MEAN|0.55||0.2988|TWO_SIDED|95.0|-1.649|0.507||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.507|-1.649|0.2988
72499463|NCT01431287|144529516|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.662|STANDARD_ERROR_OF_MEAN|0.545||0.2249|TWO_SIDED|95.0|-1.731|0.407||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.407|-1.731|0.2249
72499464|NCT01431287|144529516|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.118|STANDARD_ERROR_OF_MEAN|0.549||0.0418|TWO_SIDED|95.0|-2.195|-0.042||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||-0.042|-2.195|0.0418
72620151|NCT02837952|144771229|SUPERIORITY||Least Square Mean Difference|26.45|||<|0.001|TWO_SIDED|95.0|19.895|33.005|||ANCOVA|||0 to 8 hours: Treatment difference and 95% CI were based on least square (LS) mean from analysis of covariance (ANCOVA) with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||33.005|19.895|< 0.001
72620152|NCT02837952|144771229|SUPERIORITY||LS Mean Difference|7.91|||<|0.001|TWO_SIDED|95.0|5.196|10.632|||ANCOVA|||6 to 8 hours: Treatment difference and 95% CI were based on LS mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||10.632|5.196|< 0.001
72453173|NCT03160885|144428369|SUPERIORITY|Primary endpoints tested sequentially at a 5% significance level.|Risk Difference (RD)|11.1|||<|0.001|TWO_SIDED|95.0|5.8|16.4||Based on the primary analysis of the primary estimand 'composite'. Subjects with missing data or subjects who received rescue medication prior to Week 16 were considered non-responders.|Cochran-Mantel-Haenszel|Primary endpoints tested sequentially at a 5% significance level.|Mantel-Haenszel risk difference, stratified by region and baseline disease severity.|Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity.The null hypothesis of no difference in response rates between tralokinumab and placebo were tested against the 2-sided alternative that there is a difference.||16.4|5.8|<0.001
72453174|NCT03160885|144428370|SUPERIORITY|Primary endpoints tested sequentially at a 5% significance level.|Risk Difference (RD)|21.6|||<|0.001|TWO_SIDED|95.0|15.8|27.3||Based on the primary analysis of the primary estimand 'composite'. Subjects with missing data or subjects who received rescue medication prior to Week 16 were considered non-responders.|Cochran-Mantel-Haenszel|Primary endpoints tested sequentially at a 5% significance level.|Mantel-Haenszel risk difference, stratified by region and baseline disease severity.|Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity.The null hypothesis of no difference in response rates between tralokinumab and placebo were tested against the 2-sided alternative that there is a difference.||27.3|15.8|<0.001
72453175|NCT03160885|144428371|SUPERIORITY||Risk Difference (RD)|15.6|||<|0.001|TWO_SIDED|95.0|10.3|20.9||Based on the primary analysis of the primary estimand 'Composite', subjects who received rescue medication prior to Week 16 or have missing data at Week 16 were considered as non-responders'.|Cochran-Mantel-Haenszel|Tested sequentially at a 5% significance level.|Mantel-Haenszel risk difference, stratified by region and baseline disease severity.|Reduction of Worst Daily Pruritus NRS weekly average ≥4 at Week 16 was tested after the sequential testing of IGA 0/1 and EASI75 if these tests showed statistical significance||20.9|10.3|<0.001
72453176|NCT03160885|144428372|SUPERIORITY|Multiplicity adjustment using the Holm method.|Difference of least square means|-14.0|||<|0.001|TWO_SIDED|95.0|-18.0|-10.1||Based on the primary analysis of the primary estimand 'hypothetical'. Repeated measurements model on post-baseline data. In case of no post-baseline assessments before initiation of rescue medication, the Week 2 change was imputed as 0.|Repeated measurements model|||Data collected after permanent discontinuation of IMP or initiation of rescue medication not included.||-10.1|-18.0|<0.001
72499465|NCT01431287|144529516|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.46|STANDARD_ERROR_OF_MEAN|0.557||0.4097|TWO_SIDED|95.0|-1.552|0.633||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.633|-1.552|0.4097
72499466|NCT01431287|144529516|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.575|STANDARD_ERROR_OF_MEAN|0.556||0.3013|TWO_SIDED|95.0|-1.664|0.515||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.515|-1.664|0.3013
72499467|NCT01431287|144529516|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.115|STANDARD_ERROR_OF_MEAN|0.554||0.8355|TWO_SIDED|95.0|-0.97|1.2||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||1.200|-0.970|0.8355
72499468|NCT01431287|144529517|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.42|STANDARD_ERROR_OF_MEAN|0.135||0.0019|TWO_SIDED|95.0|0.155|0.684||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.684|0.155|0.0019
72499469|NCT01431287|144529517|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.356|STANDARD_ERROR_OF_MEAN|0.135||0.0082|TWO_SIDED|95.0|0.092|0.619||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.619|0.092|0.0082
72499470|NCT01431287|144529517|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.416|STANDARD_ERROR_OF_MEAN|0.135||0.002|TWO_SIDED|95.0|0.152|0.681||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.681|0.152|0.0020
72499471|NCT01431287|144529517|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.29|STANDARD_ERROR_OF_MEAN|0.134||0.0307|TWO_SIDED|95.0|0.027|0.554||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.554|0.027|0.0307
72562273|NCT00407745|144655844|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-4.89|STANDARD_ERROR_OF_MEAN|2.182||0.0262|TWO_SIDED|95.0|-9.19|-0.59||Significance was declared if p-value \<=0.05|ANCOVA|ANCOVA model included terms of baseline MOS 9-item Sleep Problems Index as a covariate and pooled center and treatment as fixed (class) cofactors.||Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group.||-0.59|-9.19|0.0262
72620153|NCT02837952|144771229|SUPERIORITY||LS Mean Difference|51.67|||<|0.001|TWO_SIDED|95.0|37.075|66.258|||ANCOVA|||0 to 16 hours: Treatment difference and 95% CI were based on LS mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||66.258|37.075|< 0.001
72453177|NCT03160885|144428373|SUPERIORITY|Multiplicity adjustment using Holm method.|Difference of least square means|-3.9|||<|0.001|TWO_SIDED|95.0|-5.2|-2.6||Based on the primary analysis of the primary estimand 'hypothetical'. Repeated measurements model on post-baseline data. In case of no post-baseline assessments before initiation of rescue medication, the Week 2 change was imputed as 0.|Repeated measurements model|||Data collected after permanent discontinuation of IMP or initiation of rescue medication not included.||-2.6|-5.2|<0.001
72453178|NCT03160885|144428374|SUPERIORITY||Risk Difference (RD)|34.1||||0.004|TWO_SIDED|95.0|13.4|54.9||Based on the primary analysis of the 'composite' estimand. Subjects who received rescue medication or were transferred to open-label treatment were considered non-responders.|Cochran-Mantel-Haenszel||Mantel-Haenszel risk difference compared to placebo, stratified by region.|"Testing according to the hierarchical testing procedure in the order:~IGA 0/1 at Week 52 between Q2W vs Placebo, EASI75 at Week 52 between Q2W vs Placebo, IGA 0/1 at Week 52 between Q4W vs Placebo, and EASI75 at Week 52 between Q4W vs Placebo"||54.9|13.4|0.004
72453179|NCT03160885|144428374|SUPERIORITY||Risk Difference (RD)|19.9||||0.084|TWO_SIDED|95.0|-1.2|40.9||"Based on the primary analysis of the 'composite' estimand. Subjects who received rescue medication or were transferred to open-label treatment were considered non-responders.~P value was considered non-significant"|Cochran-Mantel-Haenszel|This test was not statistically significant and hence next maintenance endpoint in the sequential testing procedure was not evaluated|Mantel-Haenszel risk difference compared to placebo, stratified by region.|"Testing according to the hierarchical testing procedure in the order:~IGA 0/1 at Week 52 between Q2W vs Placebo, EASI75 at Week 52 between Q2W vs Placebo, IGA 0/1 at Week 52 between Q4W vs Placebo, and EASI75 at Week 52 between Q4W vs Placebo"||40.9|-1.2|0.084
72453180|NCT03160885|144428375|SUPERIORITY||Risk Difference (RD)|33.7|||<|0.001|TWO_SIDED|95.0|17.3|50.0||Based on the primary analysis of the primary estimand 'composite'. Subjects who received rescue medication or were transferred to open-label treatment are considered non-responders.|Cochran-Mantel-Haenszel||Mantel-Haenszel risk difference compared to placebo, stratified by region.|"Testing according to the hierarchical testing procedure in the order:~IGA 0/1 at Week 52 between Q2W vs Placebo, EASI75 at Week 52 between Q2W vs Placebo, IGA 0/1 at Week 52 between Q4W vs Placebo, and EASI75 at Week 52 between Q4W vs Placebo"||50.0|17.3|<0.001
72453181|NCT03160885|144428375|SUPERIORITY||Risk Difference (RD)|30.0||||0.001|TWO_SIDED|95.0|13.7|46.4||Test not evaluated for statistical significance. Based on the primary analysis of the 'composite' estimand. Subjects who received rescue medication or were transferred to open-label treatment were considered non-responders.|Cochran-Mantel-Haenszel||Mantel-Haenszel risk difference compared to placebo, stratified by region.|"Testing according to the hierarchical testing procedure in the order:~IGA 0/1 at Week 52 between Q2W vs Placebo, EASI75 at Week 52 between Q2W vs Placebo, IGA 0/1 at Week 52 between Q4W vs Placebo, and EASI75 at Week 52 between Q4W vs Placebo"||46.4|13.7|0.001
72453182|NCT03160885|144428378|SUPERIORITY||Risk Difference (RD)|29.3|||<|0.001|TWO_SIDED|95.0|22.5|36.1||"Based on the primary analysis of the primary estimand 'composite'. Subjects with missing data or subjects who received rescue medication prior to Week 16 were considered non-responders.~The statistical test was not controlled for multiplicity."|Cochran-Mantel-Haenszel||Mantel-Haenszel risk difference, stratified by region and disease severity.|||36.1|22.5|<0.001
72453183|NCT03160885|144428379|SUPERIORITY||Risk Difference (RD)|12.7|||<|0.001|TWO_SIDED|95.0|8.3|17.0||"Based on the primary analysis of the primary estimand 'composite'. Subjects with missing data or subjects who received rescue medication prior to Week 16 were considered non-responders.~The statistical test was not controlled for multiplicity."|Cochran-Mantel-Haenszel||Mantel-Haenszel risk difference, stratified by region and disease severity.|||17.0|8.3|<0.001
72453184|NCT03160885|144428380|SUPERIORITY||Difference of least square means|-9.9|||<|0.001|TWO_SIDED|95.0|-12.2|-7.5||The statistical test was not controlled for multiplicity.|Repeated measurements model|||Data collected after permanent discontinuation of IMP or initiation of rescue medication not included. In case of no post-baseline assessments before initiation of rescue medication, the Week 2 change will be imputed as 0.||-7.5|-12.2|<0.001
72453185|NCT03160885|144428381|SUPERIORITY||Risk Difference (RD)|8.0|||<|0.001|TWO_SIDED|95.0|4.4|11.6||"Based on the primary analysis of the 'composite' estimand. Subjects who received rescue medication prior to Week 16 or with missing data at Week 16 were considered non-responders.~The statistical test was not controlled for multiplicity."|Cochran-Mantel-Haenszel||Mantel-Haenszel risk difference, stratified by region and baseline disease severity.|||11.6|4.4|<0.001
72453186|NCT03160885|144428382|SUPERIORITY||Risk Difference (RD)|18.9|||<|0.001|TWO_SIDED|95.0|12.8|25.1||"Based on the primary analysis of the 'composite' estimand. Subjects who received rescue medication prior to Week 16 or with missing data at Week 16 were considered non-responders.~The statistical test was not controlled for multiplicity."|Cochran-Mantel-Haenszel||Mantel-Haenszel risk difference stratified by region and disease severity.|||25.1|12.8|<0.001
72499472|NCT01431287|144529517|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.352|STANDARD_ERROR_OF_MEAN|0.135||0.0088|TWO_SIDED|95.0|0.089|0.616||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.616|0.089|0.0088
72499473|NCT01431287|144529517|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.003|STANDARD_ERROR_OF_MEAN|0.134||0.9801|TWO_SIDED|95.0|-0.259|0.266||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.266|-0.259|0.9801
72499474|NCT01431287|144529517|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.294|STANDARD_ERROR_OF_MEAN|0.134||0.0289|TWO_SIDED|95.0|0.03|0.557||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.557|0.030|0.0289
72620154|NCT02837952|144771229|SUPERIORITY||LS Mean Difference|27.32|||<|0.001|TWO_SIDED|95.0|18.139|36.508|||ANCOVA|||8 to 16 hours: Treatment difference and 95% CI were based on LS mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||36.508|18.139|< 0.001
72453187|NCT03160885|144428383|SUPERIORITY||Difference of least square means|-1.3|||<|0.001|TWO_SIDED|95.0|-1.7|-0.8||The statistical test was not controlled for multiplicity.|Repeated measurements model|||Data collected after permanent discontinuation of IMP or initiation of rescue medication not included. In case of no post-baseline assessments before initiation of rescue medication, the Week 1 change will be imputed as 0.||-0.8|-1.7|<0.001
72453188|NCT03160885|144428384|SUPERIORITY||Risk Difference (RD)|20.1|||<|0.001|TWO_SIDED|95.0|13.9|26.2||"Subjects who received rescue medication prior to Week 16 or have missing data at Week 16 were considered as non-responders.~The statistical test was not controlled for multiplicity."|Cochran-Mantel-Haenszel||Mantel-Haenszel risk difference, stratified by region and baseline disease severity.|||26.2|13.9|<0.001
72453189|NCT03160885|144428385|SUPERIORITY||Risk Difference (RD)|28.9|||<|0.001|TWO_SIDED|95.0|21.4|36.3||"Subjects who received rescue medication prior to Week 16 or have missing data at Week 16 were considered as non-responders.~The statistical test was not controlled for multiplicity."|Cochran-Mantel-Haenszel||Mantel-Haenszel risk difference, stratified by region and baseline disease severity.|||36.3|21.4|<0.001
72499475|NCT01431287|144529517|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.064|STANDARD_ERROR_OF_MEAN|0.136||0.6382|TWO_SIDED|95.0|-0.202|0.33||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.330|-0.202|0.6382
72499476|NCT01431287|144529517|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.126|STANDARD_ERROR_OF_MEAN|0.135||0.3525|TWO_SIDED|95.0|-0.14|0.391||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.391|-0.140|0.3525
72499477|NCT01431287|144529517|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.062|STANDARD_ERROR_OF_MEAN|0.135||0.6457|TWO_SIDED|95.0|-0.327|0.203||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.203|-0.327|0.6457
72499478|NCT01431287|144529518|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.033|STANDARD_ERROR_OF_MEAN|0.013||0.0095|TWO_SIDED|95.0|0.008|0.058||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.058|0.008|0.0095
72499479|NCT01431287|144529518|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.065|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|0.04|0.09||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.090|0.040|<0.0001
72499480|NCT01431287|144529518|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.033|STANDARD_ERROR_OF_MEAN|0.013||0.0112|TWO_SIDED|95.0|0.007|0.058||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.058|0.007|0.0112
72499481|NCT01431287|144529518|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.093|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|0.068|0.119||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.119|0.068|<0.0001
72499482|NCT01431287|144529518|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.064|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|0.039|0.09||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.090|0.039|<0.0001
72499483|NCT01431287|144529518|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.001|STANDARD_ERROR_OF_MEAN|0.013||0.9514|TWO_SIDED|95.0|-0.024|0.026||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.026|-0.024|0.9514
72499484|NCT01431287|144529518|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.094|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|0.069|0.119||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.119|0.069|<0.0001
72499485|NCT01431287|144529518|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.032|STANDARD_ERROR_OF_MEAN|0.013||0.0131|TWO_SIDED|95.0|-0.057|-0.007||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||-0.007|-0.057|0.0131
72453190|NCT05890794|144428390|OTHER|The difference in dose group means (0.8 mg/kg - 3.2 mg/kg) was calculated.|Mean Difference (Final Values)|40.85||||0.0005|TWO_SIDED|95.0|22.842|58.858||Significant test: 2-sided; significance level 5%.|t-test, 2 sided|A 2-sided t-test was carried out to determine whether there is a difference in means between the 0.8 mg/kg and 3.2 mg/kg dose groups.||Analysis of the difference in relative maximum change from baseline between dose groups of ilofotase alfa by a 2-sided t-test for PPi.||58.858|22.842|0.0005
72499486|NCT01431287|144529518|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.061|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|-0.086|-0.036||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||-0.036|-0.086|<0.0001
72453191|NCT05890794|144428390|OTHER|The difference between LS Means of change from baseline between dose groups was calculated. The analysis was performed using an MMRM model with fixed effects for baseline value, dose group, timepoint, interaction between dose group and timepoint, as well as random effects for patient and error|Difference in LS Means|-11.17|STANDARD_ERROR_OF_MEAN|2.681|<|0.0001|TWO_SIDED|95.0|-16.52|-5.82||Significant test: 2-sided; significance level 5%.|Mixed Models Analysis|||Analysis of the difference in relative maximum change from baseline (LS Means) between dose groups of ilofotase alfa by a mixed model repeated measures (MMRM) analysis for PPi.||-5.82|-16.52|<0.0001
72453192|NCT05890794|144428391|OTHER|The difference in dose group means (0.8 mg/kg - 3.2 mg/kg) was calculated.|Mean Difference (Final Values)|30.89|||<|0.0001|TWO_SIDED|95.0|20.831|40.941||Significant test: 2-sided; significance level 5%.|t-test, 2 sided|A 2-sided t-test was carried out to determine whether there is a difference in means between the 0.8 mg/kg and 3.2 mg/kg dose groups.||Analysis of the difference in relative maximum change from baseline between dose groups of ilofotase alfa by a 2-sided t-test for PLP.||40.941|20.831|<0.0001
72453193|NCT05890794|144428391|OTHER|The difference between LS Means of change from baseline between dose groups was calculated. The analysis was performed using an MMRM model with fixed effects for baseline value, dose group, timepoint, interaction between dose group and timepoint, as well as random effects for patient and error.|Difference in LS Means|-22.51|STANDARD_ERROR_OF_MEAN|6.289||0.0024|TWO_SIDED|95.0|-35.81|-9.2||Significant test: two-sided; significance level 5%.|Mixed Models Analysis|||Analysis of the difference in relative maximum change from baseline (LS Means) between dose groups of ilofotase alfa by an MMRM analysis for PLP.||-9.20|-35.81|0.0024
72453194|NCT05890794|144428392|OTHER|The difference in dose group means (0.8 mg/kg - 3.2 mg/kg) was calculated.|Mean Difference (Final Values)|-4335.66||||0.0019|TWO_SIDED|95.0|-6652.753|-2018.576||Significant test: 2-sided; significance level 5%.|t-test, 2 sided|A 2-sided t-test was carried out to determine whether there is a difference in means between the 0.8 mg/kg and 3.2 mg/kg dose groups.||Analysis of the difference in relative maximum change from baseline between dose groups of ilofotase alfa by a 2-sided t-test for ALP activity.||-2018.576|-6652.753|0.0019
72453195|NCT05890794|144428393|OTHER|The difference in dose group means (0.8 mg/kg - 3.2 mg/kg) was calculated.|Mean Difference (Final Values)|23.25||||0.0693|TWO_SIDED|95.0|-2.319|48.812||Significant test: 2-sided; significance level 5%.|t-test, 2 sided|A 2-sided t-test was carried out to determine whether there is a difference in means between the 0.8 mg/kg and 3.2 mg/kg dose groups.||Analysis of the difference in relative maximum change from baseline between dose groups of ilofotase alfa by a 2-sided t-test for urine PEA.||48.812|-2.319|0.0693
72453196|NCT05890794|144428393|OTHER|The difference between LS Means of change from baseline between dose groups was calculated. The analysis was performed using an MMRM model with fixed effects for baseline value, dose group, timepoint, interaction between dose group and timepoint, as well as random effects for patient and error.|Difference in LS Means|-8.76|STANDARD_ERROR_OF_MEAN|22.986||0.7086|TWO_SIDED|95.0|-57.88|40.35||Significant test: 2-sided; significance level 5%.|Mixed Models Analysis|||Analysis of the difference in relative maximum change from baseline (LS Means) between dose groups of ilofotase alfa by an MMRM analysis for urine PEA.||40.35|-57.88|0.7086
72499487|NCT01431287|144529518|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.029|STANDARD_ERROR_OF_MEAN|0.013||0.0243|TWO_SIDED|95.0|0.004|0.054||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.054|0.004|0.0243
72499488|NCT01431287|144529519|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.145|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|0.119|0.17||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.170|0.119|<0.0001
72562274|NCT00407745|144655845|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-8.67|STANDARD_ERROR_OF_MEAN|2.985||0.0041|TWO_SIDED|95.0|-14.55|-2.78||Significance was declared if p-value \<=0.05|ANCOVA|ANCOVA model included terms of baseline MOS - Sleep disturbance as a covariate and pooled center and treatment as fixed (class) cofactors.||Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group.||-2.78|-14.55|0.0041
72562275|NCT00407745|144655846|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|5.78|STANDARD_ERROR_OF_MEAN|3.492||0.0998|TWO_SIDED|95.0|-1.11|12.66||Significance was declared if p-value \<=0.05|ANCOVA|ANCOVA model included terms of baseline MOS - Sleep Adequacy as a covariate and pooled center and treatment as fixed (class) cofactors.||Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group.||12.66|-1.11|0.0998
72620155|NCT02837952|144771229|SUPERIORITY||LS Mean Difference|138.65|||<|0.001|TWO_SIDED|95.0|91.045|186.261|||ANCOVA|||0 to 48 hours: Treatment difference and 95% CI were based on LS mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||186.261|91.045|< 0.001
72453197|NCT05890794|144428394|OTHER|The difference in dose group means (0.8 mg/kg - 3.2 mg/kg) was calculated.|Mean Difference (Final Values)|187.43||||0.0199|TWO_SIDED|95.0|36.516|338.344||Significant test: 2-sided; significance level 5%.|t-test, 2 sided|A 2-sided t-test was carried out to determine whether there is a difference in means between the 0.8 mg/kg and 3.2 mg/kg dose groups.||Analysis of the difference in relative maximum change from baseline between dose groups of ilofotase alfa by a 2-sided t-test for PL.||338.344|36.516|0.0199
72453198|NCT05890794|144428394|OTHER|The difference between LS Means of change from baseline between dose groups was calculated. The analysis was performed using an MMRM model with fixed effects for baseline value, dose group, timepoint, interaction between dose group and timepoint, as well as random effects for patient and error.|Difference in LS Means|-12.51|STANDARD_ERROR_OF_MEAN|9.767||0.2034|TWO_SIDED|95.0|-31.92|6.89||Significant test: 2-sided; significance level 5%|Mixed Models Analysis|||Analysis of the difference in relative maximum change from baseline (LS Means) between dose groups of ilofotase alfa by an MMRM analysis for PL.||6.89|-31.92|0.2034
72453199|NCT05890794|144428395|OTHER|The difference in dose group means (0.8 mg/kg - 3.2 mg/kg) was calculated.|Mean Difference (Final Values)|-0.89||||0.5195|TWO_SIDED|95.0|-3.868|2.084||Significant test: 2-sided; significance level 5%.|t-test, 2 sided|A 2-sided t-test was carried out to determine whether there is a difference in means between the 0.8 mg/kg and 3.2 mg/kg dose groups.||Analysis of the difference in fold change from baseline between dose groups of ilofotase alfa by a 2-sided t-test for PL/PLP ratio.||2.084|-3.868|0.5195
72620156|NCT02837952|144771230|SUPERIORITY||||||<|0.001||||||P-value Method was based on Gehan-Wilcoxon test, stratified by sex and baseline categorical PSR.|Gehan-Wilcoxon test|||||||<0.001
72453200|NCT05890794|144428395|OTHER|The difference between LS Means of fold change from baseline between dose groups was calculated. The analysis was performed using an MMRM model with fixed effects for baseline value, dose group, timepoint, interaction between dose group and timepoint, as well as random effects for patient and error.|Difference in LS Means|1.01|STANDARD_ERROR_OF_MEAN|0.161|<|0.0001|TWO_SIDED|95.0|0.69|1.33||Significant test: 2-sided; significance level 5%.|Mixed Models Analysis|||Analysis of the difference in fold change form baseline (LS Means) between dose levels of ilofotase alfa by an MMRM analysis for PL/PLP ratio.||1.33|0.69|<0.0001
72453201|NCT04551066|144428437|SUPERIORITY||Odds Ratio (OR)|1.47||||0.2019|TWO_SIDED|95.0|0.81|2.65||calculated from Cochran Mantel-Haenszel test stratified by Baseline platelet count ≥100 x 10\^9/Liters versus 50 to \<100 x 10\^9/Liters inclusive|Cochran-Mantel-Haenszel|||||2.65|0.81|0.2019
72453202|NCT04551066|144428438|SUPERIORITY||Odds Ratio (OR)|0.83||||0.5356|TWO_SIDED|95.0|0.46|1.5||calculated from Cochran Mantel-Haenszel test stratified by Baseline platelet count ≥100 x 10\^9/Liters versus 50 to \<100 x 10\^9/Liters inclusive|Cochran-Mantel-Haenszel|||||1.50|0.46|0.5356
72453203|NCT04551066|144428440|SUPERIORITY|||||||0.9354||||||calculated from log-rank test stratified by Baseline platelet count ≥100 × 10\^9/Liters versus 50 to \<100 × 10\^9/Liters inclusive|Log Rank|||||||0.9354
72453204|NCT04551066|144428444|SUPERIORITY|||||||0.0945||||||calculated from log-rank test stratified by Baseline platelet count ≥100 × 10\^9/Liters versus 50 to \<100 × 10\^9/Liters inclusive|Log Rank|||||||0.0945
72453205|NCT03301467|144428469|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.967|TWO_SIDED|95.0|-1.9|1.8|||ANCOVA|||||1.8|-1.9|0.9670
72453206|NCT03301467|144428470|SUPERIORITY||Mean Difference (Final Values)|1.02||||0.3083|TWO_SIDED||||||Van Elteren's Test||"Test for normality showed that mean change and mean percent change were not normally distributed. As per SAP, Van Elteren's test was then applied to test mean percent change.~SAP=Statistical Analysis Protocol"|||||0.3083
72453207|NCT03301467|144428471|SUPERIORITY|||||||0.4591|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel chi square general association statistic||||||0.4591
72499489|NCT01431287|144529519|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.111|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|0.085|0.136||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.136|0.085|<0.0001
72499490|NCT01431287|144529519|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.119|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|0.094|0.144||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.144|0.094|<0.0001
72499491|NCT01431287|144529519|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.106|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|0.081|0.132||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.132|0.081|<0.0001
72453208|NCT03301467|144428472|SUPERIORITY|||||||0.3106|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel chi square general association statistic||||||0.3106
72453209|NCT03301467|144428473|SUPERIORITY||Mean Difference (Final Values)|-0.5||||0.3368|TWO_SIDED|95.0|-1.5|0.5|||ANCOVA|||||0.5|-1.5|0.3368
72453210|NCT03301467|144428474|SUPERIORITY||Mean Difference (Final Values)|-0.9||||0.0401|TWO_SIDED|95.0|-1.7|0.0|||ANCOVA|||||-0.0|-1.7|0.0401
72499492|NCT01431287|144529519|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.085|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|0.059|0.11||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.110|0.059|<0.0001
72620157|NCT02837952|144771231|SUPERIORITY||||||<|0.001||||||P-value Method was based on Gehan-Wilcoxon test, stratified by sex and baseline categorical PSR.|Gehan-Wilcoxon test|||||||<0.001
72620158|NCT01362530|144771232|SUPERIORITY_OR_OTHER||||||<|0.01|||||||Cochran-Mantel-Haenszel|Stratified by age group, use of dexamethasone as an anti-emetic, and receipt of very high risk emetogenic chemotherapy.||||||<0.01
72620159|NCT01362530|144771233|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Cochran-Mantel-Haenszel|Stratified by age group, use of dexamethasone as an anti-emetic, and receipt of very high risk emetogenic chemotherapy.||||||<0.05
72453211|NCT03301467|144428475|SUPERIORITY||Mean Difference (Final Values)|10.84||||0.0534|TWO_SIDED|95.0|-0.16|21.85|||Mixed Models Analysis|Mixed model repeated measures models with treatment group, visit, and treatment-by-visit interaction as factors and baseline as a covariate.||||21.85|-0.16|0.0534
72453212|NCT03301467|144428476|SUPERIORITY||Mean Difference (Final Values)|10.67||||0.0221|TWO_SIDED|95.0|1.56|19.78|||Mixed Models Analysis|Mixed model repeated measures models with treatment group, visit, and treatment-by-visit interaction as factors and baseline as a covariate.||||19.78|1.56|0.0221
72453213|NCT03301467|144428477|SUPERIORITY||Mean Difference (Final Values)|4.0||||0.2638|TWO_SIDED|95.0|-3.08|11.08|||Mixed Models Analysis|Mixed model repeated measures models with treatment group, visit, and treatment-by-visit interaction as factors and baseline as a covariate.||||11.08|-3.08|0.2638
72453214|NCT03301467|144428478|SUPERIORITY||Mean Difference (Final Values)|3.82||||0.2069|TWO_SIDED|95.0|-2.14|9.77|||Mixed Models Analysis|Mixed model repeated measures models with treatment group, visit, and treatment-by-visit interaction as factors and baseline as a covariate.||||9.77|-2.14|0.2069
72453215|NCT03301467|144428479|SUPERIORITY||LSM UPCR Ratio|0.98||||0.9284|TWO_SIDED|95.0|0.67|1.45|||Mixed Models Analysis|Mixed model repeated measures models with treatment group, visit, and treatment-by-visit interaction as factors and baseline as a covariate.|LSM UPCR Ratio Week 26 vs Baseline, Avacopan:Placebo|||1.45|0.67|0.9284
72499493|NCT01431287|144529519|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.026|STANDARD_ERROR_OF_MEAN|0.013||0.047|TWO_SIDED|95.0|0.0|0.051||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.051|0.000|0.0470
72499494|NCT01431287|144529519|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.132|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|0.107|0.158||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.158|0.107|<0.0001
72499495|NCT01431287|144529519|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.034|STANDARD_ERROR_OF_MEAN|0.013||0.0083|TWO_SIDED|95.0|0.009|0.06||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.060|0.009|0.0083
72499496|NCT01431287|144529519|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.013|STANDARD_ERROR_OF_MEAN|0.013||0.3329|TWO_SIDED|95.0|-0.013|0.038||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.038|-0.013|0.3329
72499497|NCT01431287|144529519|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.022|STANDARD_ERROR_OF_MEAN|0.013||0.0958|TWO_SIDED|95.0|-0.004|0.047||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.047|-0.004|0.0958
72499498|NCT01431287|144529520|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.132|STANDARD_ERROR_OF_MEAN|0.014|<|0.0001|TWO_SIDED|95.0|0.105|0.158||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.158|0.105|<0.0001
72499499|NCT01431287|144529520|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.112|STANDARD_ERROR_OF_MEAN|0.014|<|0.0001|TWO_SIDED|95.0|0.086|0.139||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.139|0.086|<0.0001
72499500|NCT01431287|144529520|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.118|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|0.092|0.144||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.144|0.092|<0.0001
72499501|NCT01431287|144529520|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.118|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|0.092|0.144||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.144|0.092|<0.0001
72620160|NCT01362530|144771234|SUPERIORITY_OR_OTHER||||||<|0.01|||||||Cochran-Mantel-Haenszel|Stratified by age group, use of dexamethasone as an anti-emetic, and receipt of very high risk emetogenic chemotherapy.||||||<0.01
72453216|NCT03301467|144428480|SUPERIORITY||LSM UPCR Ratio|0.86||||0.3778|TWO_SIDED|95.0|0.6|1.21|||Mixed Models Analysis|Mixed model repeated measures models with treatment group, visit, and treatment-by-visit interaction as factors and baseline as a covariate.|LSM UPCR Ratio Week 26 vs Baseline, Avacopan:Placebo|||1.21|0.60|0.3778
72453217|NCT03301467|144428481|SUPERIORITY||LSM MCP-1 Ratio|0.76||||0.081|TWO_SIDED|95.0|0.55|1.04|||Mixed Models Analysis|Mixed model repeated measures models with treatment group, visit, and treatment-by-visit interaction as factors and baseline as a covariate.|LSM MCP-1 Ratio Week 26 vs Baseline, Avacopan:Placebo|||1.04|0.55|0.0810
72453218|NCT03301467|144428482|SUPERIORITY||LSM MCP-1 Ratio|0.87||||0.3233|TWO_SIDED|95.0|0.66|1.15|||Mixed Models Analysis|Mixed model repeated measures models with treatment group, visit, and treatment-by-visit interaction as factors and baseline as a covariate.|LSM MCP-1 Ratio Week 26 vs Baseline, Avacopan:Placebo|||1.15|0.66|0.3233
72453219|NCT03301467|144428483|SUPERIORITY||Mean Difference (Final Values)|1.6||||0.6025|TWO_SIDED|95.0|-4.6|7.9|||Mixed Models Analysis|Mixed model repeated measures models with treatment group, visit, and treatment-by-visit interaction as factors and baseline as a covariate.||EQ-5D-5L VAS Score||7.9|-4.6|0.6025
72453220|NCT03301467|144428483|SUPERIORITY||Mean Difference (Final Values)|-0.0422||||0.1797|TWO_SIDED|95.0|-0.1043|0.0198|||Mixed Models Analysis|Mixed model repeated measures models with treatment group, visit, and treatment-by-visit interaction as factors and baseline as a covariate.||EQ-5D-5L Index Score||0.0198|-0.1043|0.1797
72453221|NCT03301467|144428484|SUPERIORITY||Mean Difference (Final Values)|-2.0||||0.4898|TWO_SIDED|95.0|-7.9|3.8|||Mixed Models Analysis|Mixed model repeated measures models with treatment group, visit, and treatment-by-visit interaction as factors and baseline as a covariate.||EQ-5D-5L VAS Score||3.8|-7.9|0.4898
72453222|NCT03301467|144428484|SUPERIORITY||Mean Difference (Final Values)|-0.0199||||0.4826|TWO_SIDED|95.0|-0.0757|0.036|||Mixed Models Analysis|Mixed model repeated measures models with treatment group, visit, and treatment-by-visit interaction as factors and baseline as a covariate.||EQ-5D-5L Index Score||0.0360|-0.0757|0.4826
72453223|NCT03301467|144428485|SUPERIORITY||Mean Difference (Final Values)|0.4019||||0.8161|TWO_SIDED|95.0|-3.0402|3.844|||Mixed Models Analysis|Mixed model repeated measures models with treatment group, visit, and treatment-by-visit interaction as factors and baseline as a covariate.||SF-36v2: Physical Component Score||3.8440|-3.0402|0.8161
72453224|NCT03301467|144428485|SUPERIORITY||Mean Difference (Final Values)|0.0052||||0.9982|TWO_SIDED|95.0|-4.5994|4.6099|||Mixed Models Analysis|Mixed model repeated measures models with treatment group, visit, and treatment-by-visit interaction as factors and baseline as a covariate.||SF-36v2: Mental Component Score||4.6099|-4.5994|0.9982
72453225|NCT03301467|144428486|SUPERIORITY||Mean Difference (Final Values)|-0.1518||||0.9242|TWO_SIDED|95.0|-3.3192|3.0156|||Mixed Models Analysis|Mixed model repeated measures models with treatment group, visit, and treatment-by-visit interaction as factors and baseline as a covariate.||SF-36v2: Physical Component Score||3.0156|-3.3192|0.9242
72453226|NCT03301467|144428486|SUPERIORITY||Mean Difference (Final Values)|1.0283||||0.6534|TWO_SIDED|95.0|-3.4972|5.5537|||Mixed Models Analysis|Mixed model repeated measures models with treatment group, visit, and treatment-by-visit interaction as factors and baseline as a covariate.||SF-36v2: Mental Component Score||5.5537|-3.4972|0.6534
72453227|NCT02798471|144428489|NON_INFERIORITY|The edoxaban-to-comparator hazard ratio will be computed with 95% confidence interval (CI) (two-sided) based on this model. Edoxaban will be considered non-inferior to comparator if the upper limit of the 95% CI is ≤1.5.|Hazard Ratio (HR)|1.01||||0.9694|TWO_SIDED|95.0|0.594|1.719|||Regression, Cox|||Statistical analysis for the composite primary efficacy endpoint||1.719|0.594|0.9694
72453228|NCT05293717|144428504|OTHER|This is an open-label study. No power calculation was performed.|||||<|0.001|||||||ANOVA|||||||<0.001
72453229|NCT03762850|144428510|OTHER||Geometric Mean Ratio|0.59|||<|0.0001|TWO_SIDED|95.0|0.51|0.69|||Mixed Models Analysis|||||0.69|0.51|<0.0001
72453230|NCT03762850|144428511|OTHER||Slope difference|1.0|STANDARD_ERROR_OF_MEAN|0.5||0.0582|TWO_SIDED|95.0|-0.03|1.94|||Mixed Models Analysis|||||1.94|-0.03|0.0582
72453231|NCT03762850|144428512|OTHER||Slope difference|1.1|STANDARD_ERROR_OF_MEAN|0.52||0.0369|TWO_SIDED|95.0|0.07|2.12|||Mixed Models Analysis|||||2.12|0.07|0.0369
72453232|NCT00979459|144428535|NON_INFERIORITY_OR_EQUIVALENCE|Administration of a single dose of two 40 mg MK-1006 FCT is similar to a single dose of four 20 mg MK-1006 DFC will be satisfied if the 90% confidence interval for the AUC(0 to infinity) geometric mean ratio (FCT/DCF) is contained within (0.70, 1.43).|Geometric mean ratio|0.93|||||TWO_SIDED|90.0|0.86|0.99||||||||0.99|0.86|
72453233|NCT00979459|144428536|NON_INFERIORITY_OR_EQUIVALENCE|Administration of a single dose of two 40 mg MK-1006 FCT is similar to a single dose of four 20 mg MK-1006 DFC will be satisfied if the 90% confidence interval for the Cmax geometric mean ratio (FCT/DCF) is contained within (0.70, 1.43).|Geometric mean ratio|1.07|||||TWO_SIDED|90.0|0.92|1.24||||||||1.24|0.92|
72453234|NCT04503681|144428546|SUPERIORITY||Median Difference (Final Values)|0.0||||0.473|TWO_SIDED|95.0|-1.1|1.1|||Wilcoxon (Mann-Whitney)|||||1.1|-1.1|0.473
72620161|NCT01362530|144771235|SUPERIORITY_OR_OTHER||||||<|0.01|||||||Cochran-Mantel-Haenszel|Stratified by age group, use of dexamethasone as an anti-emetic, and receipt of very high risk emetogenic chemotherapy.||||||<0.01
72620162|NCT04250363|144771263|OTHER||Odds Ratio (OR)|3.57||||0.00284|TWO_SIDED|95.0|1.85|10.6|||Regression, Logistic|||||10.6|1.85|0.00284
72453235|NCT04503681|144428547|SUPERIORITY||Median Difference (Final Values)|0.0||||0.338|TWO_SIDED|95.0|-0.8|0.8|||Wilcoxon (Mann-Whitney)|||||0.8|-0.8|0.338
72453236|NCT02760654|144428559|SUPERIORITY||||||<|0.05|||||||ANCOVA|||||||<0.05
72620163|NCT04250363|144771263|OTHER||Odds Ratio (OR)|4.19||||0.00367|TWO_SIDED|95.0|2.0|14.8|||Regression, Logistic|||||14.8|2.00|0.00367
72620164|NCT04250363|144771263|OTHER||Odds Ratio (OR)|4.22||||0.0137|TWO_SIDED|95.0|1.9|23.7|||Regression, Logistic|||||23.7|1.90|0.0137
72453237|NCT02760654|144428560|SUPERIORITY||||||>|0.05|||||||ANCOVA|||||||>0.05
72453238|NCT02760654|144428561|SUPERIORITY||||||>|0.05|||||||ANCOVA|||||||>0.05
72453239|NCT02760654|144428562|SUPERIORITY||||||>|0.05|||||||ANCOVA|||||||>0.05
72453240|NCT02760654|144428563|SUPERIORITY||||||>|0.05|||||||ANCOVA|||||||>0.05
72453241|NCT02760654|144428564|SUPERIORITY||||||>|0.05|||||||Fisher Exact|||||||>0.05
72453242|NCT02760654|144428565|SUPERIORITY||||||>|0.05|||||||ANCOVA|||||||>0.05
72453243|NCT02760654|144428566|EQUIVALENCE|Descriptive statistics (Mean, SD) were calculated for the 7 items of the Adapted Acceptability E-Scale|Calculated Mean and Standard Deviation|0.05|||||TWO_SIDED|||||||||||||
72453244|NCT02760654|144428567|SUPERIORITY||||||>|0.05|||||||ANCOVA|||||||>0.05
72453245|NCT02760654|144428568|SUPERIORITY||||||>|0.05|||||||ANCOVA|||||||>0.05
72453246|NCT02941549|144428596|SUPERIORITY||LS Mean Difference|-6.9||||0.5946|TWO_SIDED|95.0|-34.5|20.7|||ANCOVA|||||20.7|-34.5|0.5946
72453247|NCT02941549|144428596|SUPERIORITY||LS Mean Difference|-10.1||||0.7309|TWO_SIDED|95.0|-36.9|16.8|||ANCOVA|||||16.8|-36.9|0.7309
72453248|NCT02941549|144428597|SUPERIORITY||LS Mean Difference|-1.308||||0.0763|TWO_SIDED|95.0|-2.11|-0.51|||ANCOVA|||||-0.51|-2.11|0.0763
72453249|NCT02941549|144428597|SUPERIORITY||LS Mean Difference|-0.727||||0.0058|TWO_SIDED|95.0|-1.554|0.1|||ANCOVA|||||0.100|-1.554|0.0058
72453250|NCT05405244|144428633|SUPERIORITY|||||||0.45|||||||t-test, 2 sided|||Snack intake||||0.45
72620165|NCT04250363|144771263|OTHER||Odds Ratio (OR)|2.23||||0.00349|TWO_SIDED|95.0|1.47|4.48|||Regression, Logistic|||||4.48|1.47|0.00349
72453251|NCT05405244|144428633|SUPERIORITY|||||||0.28|||||||t-test, 2 sided|||Milkshake intake||||0.28
72453252|NCT05405244|144428634|SUPERIORITY|||||||0.89|||||||t-test, 2 sided|||Pleasantness||||0.89
72453253|NCT05405244|144428634|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||Desire to consume||||<0.001
72453254|NCT03601715|144428676|SUPERIORITY||||||<|0.05||||||Bonferroni post-hoc tests.|ANOVA|||Based on a pilot test with eight subjects, we calculated that we would need 18 subjects to give 90% power to detect the most efficient arrangement with a α level of .05. Considering losses to follow up , we increased the sample size by 10%.|Effect size was calculated through partial eta squared and correlated using Cohen index (.1 to .3 as small, .3 to .5 as medium, and over .5 as large).|||<0.05
72453255|NCT03601715|144428677|SUPERIORITY||||||<|0.05||||||Bonferroni post-hoc tests.|ANOVA|||Based on a pilot test with eight subjects, we calculated that we would need 18 subjects to give 90% power to detect the most efficient arrangement with a α level of .05. Considering losses to follow up , we increased the sample size by 10%.|Effect size was calculated through partial eta squared and correlated using Cohen index (.1 to .3 as small, .3 to .5 as medium, and over .5 as large).|||<0.05
72453256|NCT03601715|144428678|SUPERIORITY||||||<|0.05||||||Bonferroni post-hoc tests.|ANOVA|||Based on a pilot test with eight subjects, we calculated that we would need 18 subjects to give 90% power to detect the most efficient arrangement with a α level of .05. Considering losses to follow up , we increased the sample size by 10%.|Effect size was calculated through partial eta squared and correlated using Cohen index (.1 to .3 as small, .3 to .5 as medium, and over .5 as large).|||<0.05
72453257|NCT00918333|144428681|SUPERIORITY_OR_OTHER_LEGACY||Maximum Tolerated Dose (mg)|40.0|||||TWO_SIDED|||||||||||||
72453258|NCT04191824|144428748|SUPERIORITY||Mean Difference (Final Values)|-0.3||||0.7769|TWO_SIDED|95.0|-2.7|2.1||In order to maintain an overall alpha of 0.05 and account for two interim analyses, a two-sided alpha of 0.0492 was used for assessing the statistical significance in the final analysis of this primary endpoint.|t-test, 2 sided|||||2.1|-2.7|0.7769
72453259|NCT04191824|144428749|SUPERIORITY||Risk Difference (RD)|0.106|||<|0.0001|TWO_SIDED|95.0|0.061|0.151|||Chi-squared|||||0.151|0.061|<0.0001
72453260|NCT04191824|144428750|SUPERIORITY||Risk Difference (RD)|0.057||||0.0753|TWO_SIDED|95.0|-0.006|0.12|||Chi-squared|||||0.120|-0.006|0.0753
72453261|NCT04191824|144428751|SUPERIORITY||Risk Difference (RD)|0.002||||0.8044|TWO_SIDED|95.0|-0.013|0.016|||Chi-squared|||||0.016|-0.013|0.8044
72453262|NCT04191824|144428752|SUPERIORITY||Risk Difference (RD)|-0.052||||0.057|TWO_SIDED|95.0|-0.105|0.002|||Chi-squared|||||0.002|-0.105|0.0570
72453263|NCT04191824|144428753|SUPERIORITY||Risk Difference (RD)|0.045||||0.0012|TWO_SIDED|95.0|0.018|0.072|||Chi-squared|||||0.072|0.018|0.0012
72453264|NCT04191824|144428754|SUPERIORITY||Risk Difference (RD)|-0.006||||0.8483|TWO_SIDED|95.0|-0.066|0.055|||Chi-squared|||||0.055|-0.066|0.8483
72453265|NCT01499849|144428769|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.9|||<|0.001|TWO_SIDED|95.0|1.3|2.7||To control for multiplicity, analyses were performed hierarchically. For the CR delayed the threshold for statistical significance was 0.05; no further adjustment for multiplicity were required for the primary endpoint.|Cochran-Mantel-Haenszel|Cochran Mantel Haenszel (CMH) test was stratified by sex. Missing data were imputed as treatment failures.||||2.7|1.3|<0.001
72453266|NCT01499849|144428770|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.8||||0.005|TWO_SIDED|95.0|1.2|2.8||To control for multiplicity, analyses were performed hierarchically. CR-acute was tested only if the result for the primary endpoint, CR delayed, was statistically significant.|Cochran-Mantel-Haenszel|Cochran Mantel Haenszel (CMH) test was stratified by sex. Missing data were imputed as treatment failures.||||2.8|1.2|0.005
72453267|NCT01499849|144428771|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.8||||0.001|TWO_SIDED|95.0|1.3|2.6||To control for multiplicity, analyses were performed hierarchically. CR overall was tested only if both CR delayed and CR acute were statistically significant.|Cochran-Mantel-Haenszel|Cochran Mantel Haenszel (CMH) test was stratified by sex. Missing data were imputed as treatment failures.||||2.6|1.3|0.001
72562276|NCT00407745|144655847|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|5.7|STANDARD_ERROR_OF_MEAN|3.501||0.1048|TWO_SIDED|95.0|-1.2|12.61||Significance was declared if p-value \<=0.05|ANCOVA|ANCOVA model included terms of baseline MOS - Snoring as a covariate and pooled center and treatment as fixed (class) cofactors.||Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group.||12.61|-1.20|0.1048
72620166|NCT04250363|144771263|OTHER||Odds Ratio (OR)|11.6||||0.00594|TWO_SIDED|95.0|3.19|129.0|||Regression, Logistic|||||129|3.19|0.00594
72620167|NCT02197065|144771267|OTHER||Proportion|0.2|||||ONE_SIDED|||||||||This was a pilot feasibility study and we were only powered to determine the frequency of troponin elevation in the entire study population, not to compare the frequency of a rise in troponin in the two study arms. Thus Aim 1 applies to the entire study cohort.||||
72453268|NCT00174252|144428773|SUPERIORITY_OR_OTHER||Percentage|86.0|||||TWO_SIDED|95.0|74.2|93.7|||||95% CI was estimated using the F-distribution.|"Applies to no."||93.7|74.2|
72453269|NCT00174252|144428773|SUPERIORITY_OR_OTHER||Percentage|14.0||||||95.0|6.3|25.8|||||95% confidence interval (CI) was estimated using the F-distribution.|"Applies to yes."||25.8|6.3|
72453270|NCT00174252|144428787|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.35||||0.002||95.0|||||ANCOVA|Adjusted for height SD at baseline.||||||0.002
72453271|NCT00174252|144428788|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.35||||0.023||95.0||||Bilateral test multiple comparison threshold for statistical significance = 0.05|ANCOVA|Adjusted for height SD at baseline.||||||0.023
72453272|NCT00174252|144428789|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2||||0.708||95.0|||||ANCOVA|Adjusted for height SD at baseline.||||||0.708
72453273|NCT00174252|144428790|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.59||||0.325||95.0|||||ANCOVA|Adjusted for height SD at baseline.||||||0.325
72469965|NCT01080300|144463898|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-1.14|STANDARD_ERROR_OF_MEAN|0.335||0.1|TWO_SIDED|95.0|-1.8|-0.48||P-value for the test of difference of the least square mean change from baseline between Gabapentin ER 1800 mg and placebo group is based on the F-test of Type III analysis.|Based on Van Elteren|Multiplicity addressed by requiring significance for all primary endpoints.|Based on ANCOVA|"Baseline LOCF Average Daily Frequency at Week 12:~Null hypothesis: no treatment differences relative to placebo in mean change from baseline in average daily number of moderate to severe hot flashes at Week 12."||-0.48|-1.80|0.1000
72453274|NCT00811941|144428800|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.88|STANDARD_ERROR_OF_MEAN|0.62||0.16|TWO_SIDED|95.0|-2.1|0.35|||Adjusted change from Baseline to Month 6||The Number of Participants Analyzed is participants with efficacy measurement available at this endpoint, that is, 110 participants in the placebo group and 320 participants in the nalmefene group.|"The primary hypothesis concerned the treatment effect at Month 6. Null hypothesis of no difference in treatment effect was tested against the alternative hypothesis that there was a difference in treatment effect.~MMRM model with the Baseline score as a covariate; site, sex, time in months (Month 1-13); and treatment as fixed effects. The Baseline score-by-time and treatment-by-time interactions were also included in the model. An unstructured covariance matrix was used."||0.35|-2.10|0.160
72453275|NCT00811941|144428801|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.47|STANDARD_ERROR_OF_MEAN|2.9||0.232|TWO_SIDED|95.0|-9.17|2.23|||Adjusted change from Baseline to Month 6||The Number of Participants Analyzed is participants with efficacy measurement available at this endpoint, that is, 110 participants in the placebo group and 320 participants in the nalmefene group.|"The primary hypothesis concerned the treatment effect at Month 6. The null hypothesis of no difference in treatment effect was tested against the alternative hypothesis that there was a difference in treatment effect.~MMRM model with the Baseline score as a covariate; site, sex, time in months (Month 1-13); and treatment as fixed effects. The Baseline score-by-time and treatment-by-time interactions were also included in the model. An unstructured covariance matrix was used."||2.23|-9.17|0.232
72453276|NCT00811941|144428802|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.92||||0.689|TWO_SIDED|95.0|0.59|1.41|||Adjusted Odds Ratio (OR) response|||The analysis of RSDRL used a logistic regression (LREG) model, with country, sex, Baseline DRL, and treatment as fixed effects, and missing values were imputed using individual-patient predicted values of TAC derived from the MMRM model.||1.41|0.59|0.689
72453277|NCT00811941|144428803|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.18|STANDARD_ERROR_OF_MEAN|0.09||0.046|TWO_SIDED|95.0|-0.37|0.0|||Adjusted change from Baseline to Week 24||The Number of Participants Analyzed is participants with efficacy measurement available at this endpoint, that is, 104 participants in the placebo group and 306 participants in the nalmefene group.|MMRM model with the Baseline score as a covariate, and site, sex, time in weeks, and treatment as fixed effects. The Baseline score-by-time and treatment-by-time interactions were also included in the model; an unstructured covariance matrix was used.||-0.00|-0.37|0.046
72499502|NCT01431287|144529520|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.098|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|0.072|0.125||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.125|0.072|<0.0001
72499503|NCT01431287|144529520|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.014|STANDARD_ERROR_OF_MEAN|0.013||0.3008|TWO_SIDED|95.0|-0.012|0.04||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.040|-0.012|0.3008
72499504|NCT01431287|144529520|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.132|STANDARD_ERROR_OF_MEAN|0.014|<|0.0001|TWO_SIDED|95.0|0.105|0.158||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.158|0.105|<0.0001
72562277|NCT00407745|144655848|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-5.14|STANDARD_ERROR_OF_MEAN|2.417||0.0347|TWO_SIDED|95.0|-9.91|-0.37||Significance was declared if p-value \<=0.05|ANCOVA|ANCOVA model included baseline MOS - Awaken Short of Breath or with headache as covariate and pooled center and treatment as fixed (class) cofactors.||Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group.||-0.37|-9.91|0.0347
72562278|NCT00407745|144655849|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.38|STANDARD_ERROR_OF_MEAN|0.189||0.0436|TWO_SIDED|95.0|0.01|0.76||Significance was declared if p-value \<=0.05|ANCOVA|ANCOVA model included terms of baseline MOS - Sleep Quantity as a covariate and pooled center and treatment as fixed (class) cofactors.||Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group.||0.76|0.01|0.0436
72453278|NCT00811941|144428804|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.14|STANDARD_ERROR_OF_MEAN|0.11||0.217|TWO_SIDED|95.0|-0.36|0.08|||Adjusted change from Baseline to Week 24||The Number of Participants Analyzed is participants with efficacy measurement available at this endpoint, that is, 104 participants in the placebo group and 306 participants in the nalmefene group.|MMRM model with the Baseline CGI-S score as a covariate, and site, sex, time in weeks, and treatment as fixed effects. The Baseline CGI-S score-by-time and treatment by- time interactions were also included in the model. An unstructured covariance matrix was used.||0.08|-0.36|0.217
72499505|NCT01431287|144529520|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.02|STANDARD_ERROR_OF_MEAN|0.014||0.1484|TWO_SIDED|95.0|-0.007|0.046||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.046|-0.007|0.1484
72562279|NCT00407745|144655850|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|3.02|STANDARD_ERROR_OF_MEAN|2.77||0.2761|TWO_SIDED|95.0|-2.44|8.49||Significance was declared if p-value \<=0.05|ANCOVA|ANCOVA model included terms of baseline MOS - Somnolence as a covariate and pooled center and treatment as fixed (class) cofactors.||Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group.||8.49|-2.44|0.2761
72620168|NCT02197065|144771268|SUPERIORITY||Median Difference (Final Values)|13.0||||0.58|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.58
72453279|NCT00811941|144428805|SUPERIORITY_OR_OTHER||Ratio to placebo|0.93||||0.273|TWO_SIDED|95.0|0.83|1.05|||Adjusted values||The Number of Participants Analyzed is participants with efficacy measurement available at this endpoint, that is, 108 participants in the placebo group and 319 participants in the nalmefene group.|Log-transformed GGT values were analysed using an MMRM model with the logtransformed Baseline value as a covariate, and site, sex, time in weeks, and treatment as fixed effects. Log-transformed Baseline value-by-time interaction and treatment-by-time interaction were included in the model. An unstructured covariance matrix was used.||1.05|0.83|0.273
72453280|NCT00811941|144428806|SUPERIORITY_OR_OTHER||Ratio to placebo|0.99||||0.916|TWO_SIDED|95.0|0.9|1.1|||Adjusted values||The Number of Participants Analyzed is participants with efficacy measurement available at this endpoint, that is, 108 participants in the placebo group and 318 participants in the nalmefene group.|Log-transformed ALAT values were analysed using an MMRM model with the logtransformed Baseline value as a covariate, and site, sex, time in weeks, and treatment as fixed effects. Log-transformed Baseline value-by-time and treatment-by-time interactions were included in the model. An unstructured covariance matrix was used.||1.10|0.90|0.916
72453281|NCT00811941|144428807|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.57|STANDARD_ERROR_OF_MEAN|0.65||0.017|TWO_SIDED|95.0|-2.85|-0.29|||Adjusted change from Baseline - Month 13||The Number of Participants Analyzed is participants with efficacy measurement available at this endpoint, that is, 97 participants in the placebo group and 258 participants in the nalmefene group.|MMRM model with the Baseline score as a covariate; site, sex, time in months (Month 1-13); and treatment as fixed effects. The Baseline score-by-time and treatment-by-time interactions were also included in the model. An unstructured covariance matrix was used.||-0.29|-2.85|0.017
72453282|NCT00811941|144428808|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.47|STANDARD_ERROR_OF_MEAN|3.07||0.036|TWO_SIDED|95.0|-12.53|-0.42|||Adjusted change from Baseline - Month 13||The Number of Participants Analyzed is participants with efficacy measurement available at this endpoint, that is, 97 participants in the placebo group and 258 participants in the nalmefene group.|MMRM model with the Baseline score as a covariate; site, sex, time in months (Month 1-13); and treatment as fixed effects. The Baseline score-by-time and treatment-by-time interactions were also included in the model. An unstructured covariance matrix was used.||-0.42|-12.53|0.036
72453283|NCT00811941|144428809|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.01||||0.976|TWO_SIDED|95.0|0.67|1.52|||Adjusted Odds Ratio (OR) response|||The analysis of RSDRL used a logistic regression (LREG) model, with country, sex, Baseline DRL, and treatment as fixed effects, and missing values were imputed using individual-patient predicted values of TAC derived from the MMRM model.||1.52|0.67|0.976
72453284|NCT00811941|144428810|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.22|STANDARD_ERROR_OF_MEAN|0.11||0.056|TWO_SIDED|95.0|-0.44|0.01|||Adjusted change from Baseline to Week 52||The Number of Participants Analyzed is participants with efficacy measurement available at this endpoint, that is, 95 participants in the placebo group and 258 participants in the nalmefene group.|MMRM model with the Baseline score as a covariate, and site, sex, time in weeks, and treatment as fixed effects. The Baseline score-by-time and treatment-by-time interactions were also included in the model; an unstructured covariance matrix was used.||0.01|-0.44|0.056
72453285|NCT00811941|144428811|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.26|STANDARD_ERROR_OF_MEAN|0.12||0.029||95.0|-0.5|-0.03|||Adjusted change from Baseline to Week 52||The Number of Participants Analyzed is participants with efficacy measurement available at this endpoint, that is, 95 participants in the placebo group and 258 participants in the nalmefene group.|MMRM model with the Baseline CGI-S score as a covariate, and site, sex, time in weeks, and treatment as fixed effects. The Baseline CGI-S score-by-time and treatment by- time interactions were also included in the model. An unstructured covariance matrix was used.||-0.03|-0.50|0.029
72453286|NCT00811941|144428812|SUPERIORITY_OR_OTHER||Ratio to placebo|0.78||||0.001|TWO_SIDED|95.0|0.67|0.9|||Adjusted values||The Number of Participants Analyzed is participants with efficacy measurement available at this endpoint, that is, 98 participants in the placebo group and 259 participants in the nalmefene group.|Log-transformed GGT values were analysed using an MMRM model with the logtransformed Baseline value as a covariate, and site, sex, time in weeks, and treatment as fixed effects. Log-transformed Baseline value-by-time interaction and treatment-by-time interaction were included in the model. An unstructured covariance matrix was used.||0.90|0.67|0.001
72453287|NCT00811941|144428813|SUPERIORITY_OR_OTHER||Ratio to placebo|0.88||||0.037|TWO_SIDED|95.0|0.79|0.99|||Adjusted values||The Number of Participants Analyzed is participants with efficacy measurement available at this endpoint, that is, 97 participants in the placebo group and 259 participants in the nalmefene group.|Log-transformed GGT values were analysed using an MMRM model with the logtransformed Baseline value as a covariate, and site, sex, time in weeks, and treatment as fixed effects. Log-transformed Baseline value-by-time interaction and treatment-by-time interaction were included in the model. An unstructured covariance matrix was used.||0.99|0.79|0.037
72453288|NCT03802994|144428814|EQUIVALENCE|Differences between groups were compared using the paired t test|||||<|0.05|TWO_SIDED|80.0|||||t-test, 2 sided|||Differences between groups were compared using the paired t test||||<0.05
72453289|NCT03802994|144428814|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
72453290|NCT03802994|144428814|SUPERIORITY||||||<|0.05|TWO_SIDED|80.0|||||t-test, 2 sided|||||||<0.05
72453291|NCT03802994|144428815|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
72453292|NCT03802994|144428815|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
72453293|NCT03802994|144428816|SUPERIORITY||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
72453294|NCT03802994|144428817|SUPERIORITY||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
72453295|NCT03611556|144428838|SUPERIORITY||Rate difference|-8.0||||0.3614|TWO_SIDED|95.0|-27.6|12.1||Nominal P-value for comparison of treatment groups obtained from Cochran-Mantel-Haenszel-test was stratified by cluster of differentiation 73 (CD73) level.|Cochran-Mantel-Haenszel||||80% Confidence Interval 2-Sided: -20.9 to 5.2|12.1|-27.6|0.3614
72620169|NCT02197065|144771269|SUPERIORITY||Median Difference (Final Values)|0.3||||1|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||1.00
72391675|NCT03334539|144290724|SUPERIORITY||LS Mean Difference|-0.3||||0.1473|TWO_SIDED|95.0|-0.7|0.1||P-value calculated using a model with treatment, baseline score, and site as covariates.|ANCOVA|||||0.1|-0.7|0.1473
72453296|NCT03611556|144428838|SUPERIORITY||Rate difference|3.8||||0.6503|TWO_SIDED|95.0|-13.2|20.7||Nominal P-value for comparison of treatment groups obtained from Cochran-Mantel-Haenszel-test was stratified by CD73 level.|Cochran-Mantel-Haenszel||||80% Confidence Interval 2-Sided: -7.4 to 15.0|20.7|-13.2|0.6503
72453297|NCT03611556|144428845|SUPERIORITY||Hazard Ratio (HR)|1.26|||||TWO_SIDED|95.0|0.79|1.983|||||Hazard ratio for comparison between treatment groups obtained from Cox Proportional Hazards model stratified by CD73 level with ties handled by the Efron method.|||1.983|0.790|
72453298|NCT03611556|144428845|SUPERIORITY||Hazard Ratio (HR)|0.75|||||TWO_SIDED|95.0|0.498|1.131|||||Hazard ratio for comparison between treatment groups obtained from Cox Proportional Hazards model stratified by CD73 level with ties handled by the Efron method.|||1.131|0.498|
72453299|NCT03611556|144428847|SUPERIORITY||Hazard Ratio (HR)|1.16|||||TWO_SIDED|95.0|0.726|1.837|||||Hazard ratio for comparison between treatment groups obtained from Cox Proportional Hazards model stratified by CD73 level with ties handled by the Efron method.|||1.837|0.726|
72453300|NCT03611556|144428847|SUPERIORITY||Hazard Ratio (HR)|0.719|||||TWO_SIDED|95.0|0.468|1.105|||||Hazard ratio for comparison between treatment groups obtained from Cox Proportional Hazards model stratified by CD73 level with ties handled by the Efron method.|||1.105|0.468|
72391676|NCT03334539|144290724|SUPERIORITY||LS Mean Difference|-0.3||||0.2321|TWO_SIDED|95.0|-0.7|0.2||P-value calculated using a model with treatment, baseline score, and site as covariates.|ANCOVA|||||0.2|-0.7|0.2321
72453301|NCT03611556|144428851|SUPERIORITY||Rate difference|-1.7|||||TWO_SIDED|95.0|-25.2|21.9||||||||21.9|-25.2|
72453302|NCT03611556|144428851|SUPERIORITY||Rate difference|7.5|||||TWO_SIDED|95.0|-12.6|27.0||||||||27.0|-12.6|
72453303|NCT03611556|144428851|SUPERIORITY||Rate difference|-25.6|||||TWO_SIDED|95.0|-58.3|13.9||||||||13.9|-58.3|
72453304|NCT03611556|144428851|SUPERIORITY||Rate difference|-6.9|||||TWO_SIDED|95.0|-39.1|26.6||||||||26.6|-39.1|
72453305|NCT03611556|144428852|SUPERIORITY||Hazard Ratio (HR)|1.173|||||TWO_SIDED|95.0|0.676|1.985|||||Hazard ratio for comparison between treatment groups obtained from Cox Proportional Hazards model with ties handled by the Efron method.|||1.985|0.676|
72453306|NCT03611556|144428852|SUPERIORITY||Hazard Ratio (HR)|0.605|||||TWO_SIDED|95.0|0.377|0.968|||||Hazard ratio for comparison between treatment groups obtained from Cox Proportional Hazards model with ties handled by the Efron method.|||0.968|0.377|
72453307|NCT03611556|144428852|SUPERIORITY||Hazard Ratio (HR)|1.549|||||TWO_SIDED|95.0|0.622|3.917|||||Hazard ratio for comparison between treatment groups obtained from Cox Proportional Hazards model with ties handled by the Efron method.|||3.917|0.622|
72453308|NCT03611556|144428852|SUPERIORITY||Hazard Ratio (HR)|1.472|||||TWO_SIDED|95.0|0.638|3.576|||||Hazard ratio for comparison between treatment groups obtained from Cox Proportional Hazards model with ties handled by the Efron method.|||3.576|0.638|
72499506|NCT01431287|144529520|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.014||0.9981|TWO_SIDED|95.0|-0.026|0.027||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.027|-0.026|0.9981
72499507|NCT01431287|144529520|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.02|STANDARD_ERROR_OF_MEAN|0.013||0.148|TWO_SIDED|95.0|-0.007|0.046||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.046|-0.007|0.1480
72499508|NCT01431287|144529521|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.065|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|0.04|0.09||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.090|0.040|<0.0001
72453309|NCT03611556|144428854|SUPERIORITY||Hazard Ratio (HR)|1.004|||||TWO_SIDED|95.0|0.584|1.693|||||Hazard ratio for comparison between treatment groups obtained from Cox Proportional Hazards model with ties handled by the Efron method.|||1.693|0.584|
72453310|NCT03611556|144428854|SUPERIORITY||Hazard Ratio (HR)|0.598|||||TWO_SIDED|95.0|0.366|0.973|||||Hazard ratio for comparison between treatment groups obtained from Cox Proportional Hazards model with ties handled by the Efron method.|||0.973|0.366|
72453311|NCT03611556|144428854|SUPERIORITY||Hazard Ratio (HR)|1.933|||||TWO_SIDED|95.0|0.716|5.437|||||Hazard ratio for comparison between treatment groups obtained from Cox Proportional Hazards model with ties handled by the Efron method.|||5.437|0.716|
72453312|NCT03611556|144428854|SUPERIORITY||Hazard Ratio (HR)|1.374|||||TWO_SIDED|95.0|0.55|3.707|||||Hazard ratio for comparison between treatment groups obtained from Cox Proportional Hazards model with ties handled by the Efron method.|||3.707|0.550|
72453313|NCT04035447|144428865|SUPERIORITY|||||||0.519|||||||t-test, 2 sided|||Satisfaction with Therapy (ST)||||0.519
72453314|NCT04035447|144428865|SUPERIORITY|||||||0.15|||||||t-test, 2 sided|||Satisfaction with Therapist (SWT)||||0.150
72453315|NCT04035447|144428865|SUPERIORITY|||||||0.309|||||||t-test, 2 sided|||Global Improvement (Item 13)||||0.309
72453316|NCT04035447|144428867|SUPERIORITY|||||||0.696|||||||t-test, 2 sided|||||||0.696
72453317|NCT04035447|144428868|SUPERIORITY|||||||0.35|||||||t-test, 2 sided|||||||0.350
72453318|NCT04035447|144428869|SUPERIORITY|||||||0.274|||||||Fisher Exact|||Outcomes were compared at post-intervention visit: 3-month (A2) for intervention participants, 9-month (A4) for waitlist control participants.||||0.274
72453319|NCT04035447|144428870|SUPERIORITY|||||||0.6|||||||Fisher Exact|||Outcomes were compared at post-intervention visit: 3-month (A2) for intervention participants, 9-month (A4) for waitlist control participants.||||0.600
72453320|NCT04035447|144428871|SUPERIORITY||Mean Difference (Net)|1.5|STANDARD_DEVIATION|8.4||0.1848|||||||Wilcoxon (Mann-Whitney)|Effect size (Hedges' g) of 0.18||||||0.1848
72453321|NCT04035447|144428872|SUPERIORITY||Mean Difference (Net)|0.6|STANDARD_DEVIATION|8.4||0.6153|||||||Wilcoxon (Mann-Whitney)|Effect size (Hedges' g) of 0.07||||||0.6153
72453322|NCT04035447|144428873|SUPERIORITY||Mean Difference (Net)|4.6|STANDARD_DEVIATION|16.1||0.0563|||||||Wilcoxon (Mann-Whitney)|Effect size (Hedges' g) of 0.28||||||0.0563
72453323|NCT04035447|144428874|SUPERIORITY||Mean Difference (Net)|0.6|STANDARD_DEVIATION|1.8||0.0265|||||||Wilcoxon (Mann-Whitney)|Effect size (Hedges' g) of 0.31||||||0.0265
72453324|NCT04035447|144428874|SUPERIORITY||Mean Difference (Net)|0.5|STANDARD_DEVIATION|2.6||0.2084|||||||Wilcoxon (Mann-Whitney)|Effect size (Hedges' g) of 0.18||||||0.2084
72453325|NCT04035447|144428875|SUPERIORITY||Mean Difference (Net)|-1.2|STANDARD_DEVIATION|9.4||0.3512|||||||Wilcoxon (Mann-Whitney)|Effect size (Hedges' g) of -0.13||||||0.3512
72453326|NCT02397096|144428917|NON_INFERIORITY|Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate (DOR/3TC/TDF) once daily (QD) ISG is concluded to be non-inferior to baseline regimen DSG if the lower bound of the 95% CI for the difference in percent response is above -8 percentage points.|Treatment Difference|-3.784|||||TWO_SIDED|95.0|-7.877|0.31|||||Stratum-adjusted Mantel-Haenszel method with the difference weighted by the harmonic mean of sample size per arm for each stratum.||Superiority of an immediate switch to DOR/3TC/TDF over continuation of the baseline regimen was defined by a lower bound of the two-sided 95% CI for the difference in response rates being greater than zero (contingent upon satisfying the multiplicity criteria).|0.310|-7.877|
72453327|NCT02397096|144428918|OTHER||Treatment Difference|-14.65|||<|0.0001|TWO_SIDED|95.0|-18.92|-10.38|||ANCOVA||95% CIs and 2-sided p-values were calculated from an ANCOVA model with terms for baseline lipid level, use of lipid-lowering therapy at Study Day 1 and treatment.|||-10.38|-18.92|<0.0001
72453328|NCT02397096|144428919|OTHER||Treatment Difference|-23.03|||<|0.0001|TWO_SIDED|95.0|-28.0|-18.05|||ANCOVA||95% CIs and 2-sided p-values were calculated from an ANCOVA model with terms for baseline lipid level, use of lipid-lowering therapy at Study Day 1 and treatment.|||-18.05|-28.00|<0.0001
72453329|NCT02397096|144428920|NON_INFERIORITY|DOR/3TC/TDF QD ISG is concluded to be non-inferior to baseline regimen DSG if the lower bound of the 95% CI for the difference in percent response is above -8 percentage points.|Treatment Difference|-0.877|||||TWO_SIDED|95.0|-4.706|2.952|||||Stratum-adjusted Mantel-Haenszel method with the difference weighted by the harmonic mean of sample size per arm for each stratum.||Superiority of an immediate switch to DOR/3TC/TDF over continuation of the baseline regimen was defined by a lower bound of the two-sided 95% CI for the difference in response rates being greater than zero (contingent upon satisfying the multiplicity criteria).|2.952|-4.706|
72391677|NCT03334539|144290724|OTHER||LS Mean Difference|0.0||||0.8217|TWO_SIDED|95.0|-0.4|0.5||P-value calculated using a model with treatment, baseline score, and site as covariates.|ANCOVA|||||0.5|-0.4|0.8217
72453330|NCT02397096|144428921|OTHER||Mean Difference (Final Values)|-4.0|||||TWO_SIDED|95.0|-31.6|23.5|||||95% CIs were calculated based on t-distribution.|||23.5|-31.6|
72453331|NCT02397096|144428922|SUPERIORITY||Mean Difference (Final Values)|-12.8|||||TWO_SIDED|95.0|-41.1|15.4|||||95% Confidence Intervals were based on t-distribution.|||15.4|-41.1|
72453332|NCT02397096|144428923|OTHER||Treatment Difference|-3.556|||||TWO_SIDED|95.0|-7.977|0.864|||||Stratum-adjusted Mantel-Haenszel method with the difference weighted by the harmonic mean of sample size per arm for each stratum.|||0.864|-7.977|
72453333|NCT02397096|144428924|OTHER||Treatment Difference|-0.427|||||TWO_SIDED|95.0|-4.591|3.738|||||Stratum-adjusted Mantel-Haenszel method with the difference weighted by the harmonic mean of sample size per arm for each stratum.|||3.738|-4.591|
72453334|NCT02397096|144428925|NON_INFERIORITY|DOR/3TC/TDF QD ISG is concluded to be non-inferior to baseline regimen DSG if the lower bound of the 95% CI for the difference in percent response is above -4 percentage points.|Treatment Difference|-0.232|||||TWO_SIDED|95.0|-2.529|2.064|||||Stratum-adjusted Mantel-Haenszel method with the difference weighted by the harmonic mean of sample size per arm for each stratum.|||2.064|-2.529|
72453335|NCT05580003|144428937|OTHER||Ratio of Adjusted Geometric Means|101.29|||||TWO_SIDED|90.0|95.71|107.18|||||A mixed effect model was used with sequence, period and treatment as fixed effect and participant nested within sequence as random effect. Values had been back-transformed from natural log scale. Ratios (and 90% CIs) were expressed as percentages.|AUCinf||107.18|95.71|
72453336|NCT05580003|144428937|OTHER||Ratio of Adjusted Geometric Means|102.74|||||TWO_SIDED|90.0|97.28|108.5|||||A mixed effect model was used with sequence, period and treatment as fixed effect and participant nested within sequence as random effect. Values had been back-transformed from natural log scale. Ratios (and 90% CIs) were expressed as percentages.|AUCinf||108.50|97.28|
72453337|NCT05580003|144428937|OTHER||Ratio of Adjusted Geometric Means|97.83|||||TWO_SIDED|90.0|91.32|104.8|||||A mixed effect model was used with sequence, period and treatment as fixed effect and participant nested within sequence as random effect. Values had been back-transformed from natural log scale. Ratios (and 90% CIs) were expressed as percentages.|AUClast||104.80|91.32|
72453338|NCT05580003|144428937|OTHER||Ratio of Adjusted Geometric Means|102.41|||||TWO_SIDED|90.0|95.6|109.7|||||A mixed effect model was used with sequence, period and treatment as fixed effect and participant nested within sequence as random effect. Values had been back-transformed from natural log scale. Ratios (and 90% CIs) were expressed as percentages.|AUClast||109.70|95.60|
72453339|NCT05580003|144428938|OTHER||Ratio of Adjusted Geometric Means|67.18|||||TWO_SIDED|90.0|58.13|77.65|||||A mixed effect model was used with sequence, period and treatment as fixed effect and participant nested within sequence as random effect. Values had been back-transformed from natural log scale. Ratios (and 90% CIs) were expressed as percentages.|||77.65|58.13|
72453340|NCT05580003|144428938|OTHER||Ratio of Adjusted Geometric Means|74.12|||||TWO_SIDED|90.0|64.14|85.67|||||A mixed effect model was used with sequence, period and treatment as fixed effect and participant nested within sequence as random effect. Values had been back-transformed from natural log scale. Ratios (and 90% CIs) were expressed as percentages.|||85.67|64.14|
72453341|NCT05580003|144428974|OTHER||Ratio of Adjusted Geometric Means|72.87|||||TWO_SIDED|90.0|60.98|87.09|||||A paired t-test was used. Values had been back-transformed from natural log scale. Ratios (and 90% CIs) were expressed as percentages|AUCinf||87.09|60.98|
72499509|NCT01431287|144529521|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.036|STANDARD_ERROR_OF_MEAN|0.013||0.005|TWO_SIDED|95.0|0.011|0.061||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.061|0.011|0.0050
72499510|NCT01431287|144529521|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.064|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|0.039|0.089||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.089|0.039|<0.0001
72453342|NCT05580003|144428974|OTHER||Ratio of Adjusted Geometric Means|76.45|||||TWO_SIDED|90.0|68.35|85.52|||||A paired t-test was used. Values had been back-transformed from natural log scale. Ratios (and 90% CIs) were expressed as percentages|AUCinf||85.52|68.35|
72453343|NCT05580003|144428974|OTHER||Ratio of Adjusted Geometric Means|73.52|||||TWO_SIDED|90.0|65.7|82.27|||||A paired t-test was used. Values had been back-transformed from natural log scale. Ratios (and 90% CIs) were expressed as percentages|AUClast||82.27|65.70|
72453344|NCT05580003|144428974|OTHER||Ratio of Adjusted Geometric Means|75.16|||||TWO_SIDED|90.0|66.36|85.13|||||A paired t-test was used. Values had been back-transformed from natural log scale. Ratios (and 90% CIs) were expressed as percentages|AUClast||85.13|66.36|
72453345|NCT05580003|144428975|OTHER||Ratio of Adjusted Geometric Means|76.72|||||TWO_SIDED|90.0|60.21|97.75|||||A paired t-test was used. Values had been back-transformed from natural log scale. Ratios (and 90% CIs) were expressed as percentages|||97.75|60.21|
72453346|NCT05580003|144428975|OTHER||Ratio of Adjusted Geometric Means|70.92|||||TWO_SIDED|90.0|53.7|93.67|||||A paired t-test was used. Values had been back-transformed from natural log scale. Ratios (and 90% CIs) were expressed as percentages|||93.67|53.70|
72453347|NCT02392234|144429012|SUPERIORITY||Least Squares (LS) Mean Difference|4.7|||<|0.0001|TWO_SIDED|95.0|3.7|5.8|||Linear Mixed Effects Model|||||5.8|3.7|< 0.0001
72453348|NCT02392234|144429012|SUPERIORITY||LS Mean Difference|6.8|||<|0.0001|TWO_SIDED|95.0|5.7|7.8|||Linear Mixed Effects Model|||||7.8|5.7|< 0.0001
72453349|NCT02392234|144429013|SUPERIORITY||LS Mean Difference|9.7|||<|0.0001|TWO_SIDED|95.0|7.2|12.2|||Linear Mixed Effects Model|||||12.2|7.2|<0.0001
72453350|NCT02392234|144429013|SUPERIORITY||LS Mean Difference|11.1|||<|0.0001|TWO_SIDED|95.0|8.7|13.6|||Linear Mixed Effects Model|||||13.6|8.7|<0.0001
72453351|NCT02392234|144429015|SUPERIORITY||LS Mean Difference|8.1|||<|0.0001|TWO_SIDED|95.0|6.3|9.9|||Linear Mixed Effects Model|||||9.9|6.3|<0.0001
72453352|NCT02392234|144429015|SUPERIORITY||LS Mean Difference|11.4|||<|0.0001|TWO_SIDED|95.0|9.6|13.2|||Linear Mixed Effects Model|||||13.2|9.6|<0.0001
72453353|NCT02392234|144429016|SUPERIORITY||LS Mean Difference|-4.5|||<|0.0001|TWO_SIDED|95.0|-6.7|-2.3|||Linear Mixed Effects Model|||||-2.3|-6.7|<0.0001
72453354|NCT02392234|144429016|SUPERIORITY||LS Mean Difference|-9.5|||<|0.0001|TWO_SIDED|95.0|-11.7|-7.3|||Linear Mixed Effects Model|||||-7.3|-11.7|<0.0001
72453355|NCT02130557|144429023|SUPERIORITY||Odds Ratio (OR)|1.547||||0.01|TWO_SIDED|95.0|1.072|2.233||1-sided p-value based on CMH test for general association between treatment and response with stratification by sokal risk group (low, intermediate, high) and region (1-3) at time of randomization. Statistical significance threshold: 1-sided 0.025.|Cochran-Mantel-Haenszel||95% Confidence Interval (CI) for the odds ratio adjusted for sokal risk group and region are based on Mantel-Haenszel confidence limits.|A total sample size of 500 Ph+ participants is required for the study to provide \>= 90% power to detect at least 15% difference (assuming 25% in the imatinib vs 40% in the bosutinib arm) in the MMR rates at 12 months (48 weeks) with a 1-sided alpha of 2.5%, and 2 interim futility analyses at 33% and 66% of patients with adequate follow-up with early stopping for futility only (non-binding, O'Brien-Fleming analog beta spending function).||2.233|1.072|0.0100
72453356|NCT02130557|144429024|SUPERIORITY||Odds Ratio (OR)|1.418||||0.0303|TWO_SIDED|95.0|0.986|2.037||1-sided p-value based on CMH test for general association between treatment and response with stratification by sokal risk group (low, intermediate, high) and region (1-3) at time of randomization. Statistical significance threshold: 1-sided 0.0125.|Cochran-Mantel-Haenszel||95% CI for the odds ratio adjusted for sokal risk group and region are based on Mantel-Haenszel confidence limits.|If the primary analysis was significant, each member of the short-term family (CCyR by Month 12, MMR by Month 18) was tested via Bonferroni's procedure at the 1-sided level of 0.0125.||2.037|0.986|0.0303
72453357|NCT02130557|144429025|SUPERIORITY||Hazard Ratio (HR)|1.09|||||TWO_SIDED|95.0|0.49|2.44|||||Hazard ratio (95% CIs) are based on the treatment effect (Bosutinib compared with Imatinib) in a stratified (by Sokal risk group at randomization and region) Cox proportional hazards model for the hazard of the respective event.|The medians have not been reached in either arm, as such, the premature estimated hazard ratio is provided.||2.44|0.49|
72453358|NCT02130557|144429026|SUPERIORITY||Odds Ratio (OR)|1.74||||0.0037|TWO_SIDED|95.0|1.16|2.61||1-sided p-value based on CMH test for general association between treatment and response with stratification by sokal risk group (low, intermediate, high) and region (1-3) at time of randomization. Statistical significance threshold: 1-sided 0.0125.|Cochran-Mantel-Haenszel||95% CI for the odds ratio adjusted for sokal risk group and region are based on Mantel-Haenszel confidence limits.|If the primary analysis was significant, each member of the short-term family (CCyR by Month 12, MMR by Month 18) was tested via Bonferroni's procedure at the 1-sided level of 0.0125.||2.610|1.160|0.0037
72453359|NCT02130557|144429027|SUPERIORITY||Hazard Ratio (HR)|0.39|||||TWO_SIDED|95.0|0.14|1.13|||||Hazard ratio (95% CIs) are based on the treatment effect (Bosutinib compared with Imatinib) in a stratified (by Sokal risk group at randomization and region) Cox proportional hazards model for the hazard of the respective event.|The medians have not been reached in either arm, as such, the premature estimated hazard ratio is provided.||1.13|0.14|
72499511|NCT01431287|144529521|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.063|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|0.037|0.088||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.088|0.037|<0.0001
72499512|NCT01431287|144529521|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.036|STANDARD_ERROR_OF_MEAN|0.013||0.0057|TWO_SIDED|95.0|0.01|0.061||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.061|0.010|0.0057
72453360|NCT02130557|144429028|SUPERIORITY||Hazard Ratio (HR)|0.64||||0.0749|TWO_SIDED|95.0|0.35|1.17||1-sided p-value based on Gray's test for comparing cumulative incidence function between treatment arms stratified by sokal risk group (low, intermediate, high) and region (1-3). Statistical significance threshold: 1-sided 0.0125.|Gray's test||The hazard ratio (95% CIs) are based on the proportional subdistribution hazards model stratified by Sokal risk group and region.|If each member of the short-term family (CCyR by Month 12, MMR by Month 18) was significant, EFS and OS were tested sequentially via the Holm's testing procedure at the 1-sided family wise level of 0.025. If one member of the short-term family was significant, EFS and OS were tested sequentially at 1-sided 0.0125.||1.17|0.35|0.0749
72453361|NCT02130557|144429029|SUPERIORITY||Hazard Ratio (HR)|0.8||||0.2827|TWO_SIDED|95.0|0.37|1.73||1-sided p-value based on log-rank test for comparing survival curves between treatment arms stratified by sokal risk group and region. OS was not tested as EFS was not significant.|Log Rank||The hazard ratio (95% CIs) are based on the treatment effect (Bosutinib compared with Imatinib) in a stratified (by Sokal risk group at randomization and region) Cox proportional hazards model for the hazard of the respective event.|If each member of the short-term family (CCyR by Month 12, MMR by Month 18) was significant, EFS and OS were tested sequentially via the Holm's testing procedure at the 1-sided family wise level of 0.025. If one member of the short-term family was significant, EFS and OS were tested sequentially at 1-sided 0.0125.||1.73|0.37|0.2827
72453362|NCT03333109|144429050|SUPERIORITY||Mean Difference (Final Values)|-1.09|STANDARD_ERROR_OF_MEAN|0.34||0.002|TWO_SIDED|95.0|-1.77|-0.42|||Mixed Models Analysis|||||-0.42|-1.77|0.002
72453363|NCT03333109|144429050|SUPERIORITY||Median Difference (Final Values)|-1.69|STANDARD_ERROR_OF_MEAN|0.39|<|0.001|TWO_SIDED|95.0|-2.45|-0.93|||Mixed Models Analysis|||||-0.93|-2.45|<0.001
72453364|NCT03333109|144429051|SUPERIORITY||Odds Ratio (OR)|1.52||||0.007|TWO_SIDED|95.0|1.12|2.07|||Cochran-Mantel-Haenszel|Haenszel (CMH) test adjusted for stratification factor after missing data were imputed as non-response (NRI).||||2.07|1.12|0.007
72453365|NCT03333109|144429051|SUPERIORITY||Odds Ratio (OR)|2.21|||<|0.001|TWO_SIDED|95.0|1.55|3.15|||Cochran-Mantel-Haenszel|Haenszel (CMH) test adjusted for stratification factor after missing data were imputed as non-response (NRI).||||3.15|1.55|<0.001
72453366|NCT03333109|144429052|SUPERIORITY||Mean Difference (Final Values)|-1.36|STANDARD_ERROR_OF_MEAN|0.36|<|0.001|TWO_SIDED|95.0|-2.07|-0.64|||Mixed Models Analysis|||||-0.64|-2.07|<0.001
72453367|NCT03333109|144429052|SUPERIORITY||Mean Difference (Net)|-1.9|STANDARD_ERROR_OF_MEAN|0.41|<|0.001|TWO_SIDED|95.0|-2.71|-1.09|||Mixed Models Analysis|||||-1.09|-2.71|<0.001
72453368|NCT03333109|144429053|SUPERIORITY||Mean Difference (Final Values)|-1.77|STANDARD_ERROR_OF_MEAN|0.62||0.004|TWO_SIDED|95.0|-2.99|-0.56|||Mixed Models Analysis|||||-0.56|-2.99|0.004
72453369|NCT03333109|144429053|SUPERIORITY||Mean Difference (Final Values)|-2.71|STANDARD_ERROR_OF_MEAN|0.69|<|0.001|TWO_SIDED|95.0|-4.07|-1.36|||Mixed Models Analysis|||||-1.36|-4.07|<0.001
72453370|NCT01447706|144429074|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.37||||0.007|TWO_SIDED|95.0|0.18|0.76|||Log Rank|||||0.76|0.18|0.007
72453371|NCT01447706|144429074|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.8||||0.023|TWO_SIDED|95.0|1.08|2.98|||Log Rank|||||2.98|1.08|0.023
72453372|NCT00918203|144429075|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.29||||0.2133|TWO_SIDED|95.0|0.86|1.93|||Log Rank|||||1.93|0.86|0.2133
72453373|NCT00918203|144429078|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.04||||0.8731|TWO_SIDED|95.0|0.68|1.57|||Log Rank|||||1.57|0.68|0.8731
72453374|NCT00918203|144429079|SUPERIORITY_OR_OTHER|||||||0.4721|||||||Fisher Exact|||||||0.4721
72453375|NCT05613907|144429144|SUPERIORITY||Mean Difference (Net)|-21.6|STANDARD_ERROR_OF_MEAN|5.885||0.005|TWO_SIDED|95.0|-37.05|-6.15|||ANOVA|||||-6.150|-37.050|0.005
72453376|NCT05613907|144429144|SUPERIORITY||Mean Difference (Net)|-17.8|STANDARD_ERROR_OF_MEAN|6.512||0.04|TWO_SIDED|95.0|-34.895|-0.705|||ANOVA|||||-0.705|-34.895|0.040
72453377|NCT05613907|144429144|SUPERIORITY||Mean Difference (Net)|3.8|STANDARD_ERROR_OF_MEAN|3.668||0.94|TWO_SIDED|95.0|-5.829|13.429|||ANOVA|||||13.429|-5.829|0.940
72453378|NCT05613907|144429145|SUPERIORITY||Z statistic|-0.862||||0.388|TWO_SIDED||||||Wilcoxon Signed Ranks|||The null hypothesis is that there will be no significant difference in the EuroQol 5-D domains at 1 year compared to baseline.||||0.388
72453379|NCT05613907|144429146|SUPERIORITY||Z statistic|-0.033||||0.974|TWO_SIDED||||||Wilcoxon signed rank|||The null hypothesis is that there will be no statistical difference in patient self-reported ability to perform basic self-care||||0.974
72453380|NCT05613907|144429147|SUPERIORITY||Z statistic|-1.564||||0.118|TWO_SIDED||||||Wilcoxon signed rank|||The null hypothesis is no improvement in ability to perform usual activities at 1 year.||||0.118
72453381|NCT05613907|144429148|SUPERIORITY||Z statistic|-2.364||||0.018|TWO_SIDED||||||Wilcoxon signed rank|||||||0.018
72453382|NCT05613907|144429149|SUPERIORITY||Z statistic|-1.311||||0.19|TWO_SIDED|||||The null hypothesis is that there will be no difference in anxiety and/or depression compared to the initial visit.|Wilcoxon signed rank|||||||0.190
72453383|NCT05613907|144429150|SUPERIORITY||Mean Difference (Net)|-26.846|STANDARD_ERROR_OF_MEAN|8.604||0.027|TWO_SIDED|95.0|-50.762|-2.39|||ANOVA|||||-2.390|-50.762|0.027
72453384|NCT05613907|144429150|SUPERIORITY||Mean Difference (Net)|-27.615|STANDARD_ERROR_OF_MEAN|8.715||0.024|TWO_SIDED|95.0|-51.837|-3.394|||ANOVA|||||-3.394|-51.837|0.024
72453385|NCT05613907|144429150|SUPERIORITY||Mean Difference (Net)|-0.769|STANDARD_ERROR_OF_MEAN|4.535||1|TWO_SIDED|95.0|-13.374|11.836|||ANOVA|||||11.836|-13.374|1.000
72453386|NCT05613907|144429151|SUPERIORITY||Mean Difference (Net)|-14.27|STANDARD_ERROR_OF_MEAN|4.052||0.048|TWO_SIDED|95.0|-37.05|-6.15|||ANOVA|||||-6.150|-37.050|0.048
72453387|NCT05613907|144429151|SUPERIORITY||Median Difference (Final Values)|-3.12|STANDARD_ERROR_OF_MEAN|3.751||1|TWO_SIDED|95.0|-12.893|13.751|||ANOVA|||||13.751|-12.893|1.000
72453388|NCT05613907|144429151|SUPERIORITY||Mean Difference (Net)|12.26|STANDARD_ERROR_OF_MEAN|5.186||0.163|TWO_SIDED|95.0|-4.762|29.333|||ANOVA|||||29.333|-4.762|0.163
72453389|NCT00490139|144429152|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.84||||0.048|TWO_SIDED|95.0|0.71|1.0|||Log Rank|Stratification was by chemotherapy timing, hormone receptor status, and axillary lymph node status.|The estimate of the treatment hazard ratio (lap plus tras versus tras) was based on the Cox proportional hazards model adjusting for the stratification factors of chemotherapy timing, hormone receptor status, and axillary lymph node status.|||1.00|0.71|0.048
72391678|NCT03302234|144290793|OTHER||Hazard Ratio (HR)|1.08||||0.74156|TWO_SIDED|95.0|0.85|1.37||One-sided p-value based on log-rank test stratified by ECOG, geographic region of the enrolling site, and predominant tumor history.|Log Rank||Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG, geographic region of the enrolling site, and predominant tumor history.|||1.37|0.85|0.74156
72562280|NCT00407745|144655851|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.81||||0.0024|TWO_SIDED|95.0|1.443|5.491||Significance was declared if p-value \<=0.05|Regression, Logistic|Logistic Regression Model included Pooled Center and Treatment as the categorical factors, and Optimal Sleep Score at Baseline as the covariate.||Null hypothesis - The rate of subjects with optimal sleep for the pregabain group was equal to the rate of subjects with optimal sleep for the placebo group; Alternative hypothesis - The rate of subjects with optimal sleep for the pregabain group was not equal to the rate of subjects with optimal sleep for the placebo group.||5.491|1.443|0.0024
72562281|NCT00407745|144655852|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.68|STANDARD_ERROR_OF_MEAN|0.433||0.1164|TWO_SIDED|95.0|-1.54|0.17||Significance was declared if p-value \<=0.05|ANCOVA|ANCOVA model included terms of baseline HADS - Anxiety as a covariate and pooled center and treatment as fixed (class) cofactors.||Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group.||0.17|-1.54|0.1164
72562282|NCT00407745|144655853|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.99|STANDARD_ERROR_OF_MEAN|0.447||0.0279|TWO_SIDED|95.0|-1.87|-0.11||Significance was declared if p-value \<=0.05|ANCOVA|ANCOVA model included terms of baseline HADS - Depression as a covariate and pooled center and treatment as fixed (class) cofactors.||Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group.||-0.11|-1.87|0.0279
72620170|NCT00276380|144771270|OTHER||Odds Ratio (OR)|0.83||||0.52|TWO_SIDED|95.0|0.46|1.48|||Cochran-Mantel-Haenszel||The homogeneity of the Odds Ratio (OR) across centres was assessed by the Breslow Day test.|The association between treatment and response after adjustment for the pooled centres was analysed using a Cochran-Mantel-Haenszel test.||1.48|0.46|0.52
72391679|NCT03302234|144290794|OTHER||Hazard Ratio (HR)|1.06||||0.7172|TWO_SIDED|95.0|0.86|1.3|||Log Rank|One-sided p-value based on log-rank test stratified by ECOG, geographic region of the enrolling site, and predominant tumor history.|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG, geographic region of the enrolling site and predominant tumor history.|||1.30|0.86|0.71720
72391680|NCT03302234|144290795|OTHER||Difference in percentage|-0.1||||0.50644|TWO_SIDED|95.0|-8.2|8.1|||Miettinen & Nurminen method|One-sided p-value for testing|Based on Miettinen \& Nurminen method stratified by ECOG, geographic region of the enrolling site and predominant tumor history.|||8.1|-8.2|0.50644
72391681|NCT03302234|144290797|OTHER||Hazard Ratio (HR)|0.9815||||0.9112|TWO_SIDED|95.0|0.7386|1.3042|||Log Rank|Two-sided p-value based on log-rank test stratified by ECOG, geographic region of the enrolling site, and predominant tumor histology.|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG, geographic region of the enrolling site, and predominant tumor histology.|||1.3042|0.7386|0.9112
72391682|NCT03302234|144290800|OTHER||Difference in LS Means|-0.42||||0.8151|TWO_SIDED|95.0|-3.96|3.12|||cLDA Model|Constrained longitudinal data analysis (cLDA) Model|Based on a cLDA model with PRO scores as response variable, with covariates for treatment by time interaction, and stratification factors (ECOG, geographic region of the enrolling site, \& predominant tumor histology) as covariates.|||3.12|-3.96|0.8151
72391683|NCT02795832|144290801|SUPERIORITY|ANCOVA model was fitted with percent change from baseline to Week 2 in EASI score as the dependent variable. Explanatory variables fitted were: treatment group (ZPL-5212372, placebo) and baseline EASI score as a continuous variable.|Mean Difference (Net)|0.05|STANDARD_ERROR_OF_MEAN|12.441||0.5016|TWO_SIDED|90.0|-21.24|21.34||The 1-sided p-value tests if the ZPL-5212372 LS mean is \< the placebo LS mean.|ANCOVA|||Observed case||21.34|-21.24|0.5016
72391684|NCT02795832|144290801|SUPERIORITY|ANCOVA model was fitted with percent change from baseline to Week 2 in EASI score as the dependent variable. Explanatory variables fitted were: treatment group (ZPL-5212372, placebo) and baseline EASI score as a continuous variable.|Mean Difference (Net)|-3.01|STANDARD_ERROR_OF_MEAN|12.964||0.4082|TWO_SIDED|90.0|-24.39|18.36||The 1-sided p-value tests if the ZPL-5212372 LS mean is \< the placebo LS mean.|ANCOVA|||Multiple imputations||18.36|-24.39|0.4082
72391685|NCT02795832|144290801|SUPERIORITY|ANCOVA model was fitted with percent change from baseline to Week 2 in EASI score as the dependent variable. Explanatory variables fitted were: treatment group (ZPL-5212372, placebo) and baseline EASI score as a continuous variable.|Mean Difference (Net)|-18.27|STANDARD_ERROR_OF_MEAN|13.138||0.0878|TWO_SIDED|90.0|-40.65|4.11||The 1-sided p-value tests if the ZPL-5212372 LS mean is \< the placebo LS mean.|ANCOVA|||Last observation carried forward||4.11|-40.65|0.0878
72453390|NCT00490139|144429152|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.96||||0.61|TWO_SIDED|95.0|0.81|1.13|||Log Rank|Stratification was by chemotherapy timing, hormone receptor status, and axillary lymph node status.|The estimate of the treatment hazard ratio (lap plus tras versus tras) was based on the Cox proportional hazards model adjusting for the stratification factors of chemotherapy timing, hormone receptor status, and axillary lymph node status.|||1.13|0.81|0.610
72453391|NCT00490139|144429153|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.887|||||TWO_SIDED|95.0|0.77|1.02|||||The estimate of the treatment hazard ratio (lap plus tras versus tras) was based on the Cox proportional hazards model adjusting for the stratification factors of chemotherapy timing, hormone receptor status, and axillary lymph node status.|||1.02|0.77|
72453392|NCT00490139|144429153|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.914|||||TWO_SIDED|95.0|0.8|1.05|||||The estimate of the treatment hazard ratio (lap plus tras versus tras) was based on the Cox proportional hazards model adjusting for the stratification factors of chemotherapy timing, hormone receptor status, and axillary lymph node status.|||1.05|0.80|
72453393|NCT00490139|144429154|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.8||||0.078|TWO_SIDED|95.0|0.62|1.03|||Log Rank|Stratification was by chemotherapy timing, hormone receptor status, and axillary lymph node status.|The estimate of the treatment hazard ratio (lap plus tras versus tras) was based on the Cox proportional hazards model adjusting for the stratification factors of chemotherapy timing, hormone receptor status, and axillary lymph node status.|||1.03|0.62|0.078
72391686|NCT02795832|144290801|SUPERIORITY|ANCOVA model was fitted with percent change from baseline to Week 2 in EASI score as the dependent variable. Explanatory variables fitted were: treatment group (ZPL-5212372, placebo) and baseline EASI score as a continuous variable.|Mean Difference (Net)|-37.6|STANDARD_ERROR_OF_MEAN|18.748||0.0275|TWO_SIDED|90.0|-69.53|-5.66||The 1-sided p-value tests if the ZPL-5212372 LS mean is \< the placebo LS mean.|ANCOVA|||Worst case imputation||-5.66|-69.53|0.0275
72453394|NCT00490139|144429154|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.91||||0.433|TWO_SIDED|95.0|0.71|1.16|||Log Rank|Stratification was by chemotherapy timing, hormone receptor status, and axillary lymph node status.|The estimate of the treatment hazard ratio (tras followed by lap versus tras) was based on the Cox proportional hazards model adjusting for the stratification factors of chemotherapy timing, hormone receptor status, and axillary lymph node status.|||1.16|0.71|0.433
72453395|NCT00490139|144429155|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.853|||||TWO_SIDED|95.0|0.7|1.03|||||The estimate of the treatment hazard ratio (lap plus tras versus tras) was based on the Cox proportional hazards model adjusting for the stratification factors of chemotherapy timing, hormone receptor status, and axillary lymph node status.|||1.03|0.70|
72453396|NCT00490139|144429155|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.863|||||TWO_SIDED|95.0|0.71|1.04|||||The estimate of the treatment hazard ratio (tras followed by lap versus tras) was based on the Cox proportional hazards model adjusting for the stratification factors of chemotherapy timing, hormone receptor status, and axillary lymph node status.|||1.04|0.71|
72453397|NCT00490139|144429156|SUPERIORITY_OR_OTHER_LEGACY|Time to recurrence was analyzed using competing risks methodology with death (without event) as a competing risk.|Hazard Ratio (HR)|0.811|||||TWO_SIDED|95.0|0.68|0.96||||||||0.96|0.68|
72453398|NCT00490139|144429156|SUPERIORITY_OR_OTHER_LEGACY|Time to recurrence was analyzed using competing risks methodology with death (without event) as a competing risk.|Hazard Ratio (HR)|0.93|||||TWO_SIDED|95.0|0.79|1.1||||||||1.10|0.79|
72453399|NCT00490139|144429157|SUPERIORITY_OR_OTHER_LEGACY|Time to distant recurrence was analyzed using competing risks methodology with death (without event) as a competing risk.|Hazard Ratio (HR)|0.852|||||TWO_SIDED|95.0|0.71|1.02||||||||1.02|0.71|
72453400|NCT00490139|144429157|SUPERIORITY_OR_OTHER_LEGACY|Time to distant recurrence was analyzed using competing risks methodology with death (without event) as a competing risk.|Hazard Ratio (HR)|0.968|||||TWO_SIDED|95.0|0.81|1.16||||||||1.16|0.81|
72453401|NCT00490139|144429158|SUPERIORITY_OR_OTHER_LEGACY|Time to CNS recurrence was analyzed using competing risks methodology with death (without event) as a competing risk.|Hazard Ratio (HR)|0.986|||||TWO_SIDED|95.0|0.74|1.31||||||||1.31|0.74|
72453402|NCT00490139|144429158|SUPERIORITY_OR_OTHER_LEGACY|Time to CNS recurrence was analyzed using competing risks methodology with death (without event) as a competing risk.|Hazard Ratio (HR)|0.98|||||TWO_SIDED|95.0|0.74|1.31||||||||1.31|0.74|
72453403|NCT04484623|144429161|SUPERIORITY||Hazard Ratio (HR)|0.52|||<|0.001|TWO_SIDED|95.0|0.37|0.73||P-Value presented to 3 decimal places from one-sided stratified Log-Rank test adjusting for the number of lines of prior therapy (1 vs. 2/3 vs. \>=4) and prior bortezomib (yes or no) according to IVRS strata.|Log Rank||Hazard ratio was estimated using a Cox Proportional Hazards model stratified by the number of lines of prior therapy (1 vs. 2/3 vs. \>=4) and prior bortezomib (yes or no) according to IVRS strata with a covariate of treatment.|||0.73|0.37|<0.001
72453404|NCT06140290|144429193|EQUIVALENCE|The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. Here, Etrasimod 2mg (Treatment F) with practice session was the reference treatment, while Etrasimod 2mg (Treatment G) without practice session was the test treatment.|Ratio of Adjusted Geometric Means|108.32|||||TWO_SIDED|90.0|101.2|115.94|||||Ratio (Test/Reference) and its associated 90% CI were expressed as percentages.|Analysis was performed using a mixed effect model, with treatment as a fixed effect and participant as a random effect.||115.94|101.20|
72453405|NCT06140290|144429194|EQUIVALENCE|The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. Here, Etrasimod 2mg (Treatment F) with practice session was the reference treatment, while Etrasimod 2mg (Treatment G) without practice session was the test treatment.|Ratio of Adjusted Geometric Means|120.41|||||TWO_SIDED|90.0|108.02|134.22|||||Ratio (Test/Reference) and its associated 90% CI were expressed as percentages.|Analysis was performed using a mixed effect model, with treatment as a fixed effect and participant as a random effect.||134.22|108.02|
72453406|NCT06140290|144429195|EQUIVALENCE|The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. Here, Etrasimod 2mg (Treatment F) with practice session was the reference treatment, while Etrasimod 2mg (Treatment G) without practice session was the test treatment.|Ratio of Adjusted Geometric Means|115.29|||||TWO_SIDED|90.0|105.17|126.38|||||Ratio (Test/Reference) and its associated 90% CI were expressed as percentages.|Analysis was performed using a mixed effect model, with treatment as a fixed effect and participant as a random effect.||126.38|105.17|
72453407|NCT06140290|144429196|EQUIVALENCE|The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. Here, Etrasimod 2mg (Treatment F) with practice session was the reference treatment, while Etrasimod 2mg (Treatment G) without practice session was the test treatment.|Ratio of Adjusted Geometric Means|106.75|||||TWO_SIDED|90.0|99.33|114.73|||||Ratio (Test/Reference) and its associated 90% CI were expressed as percentages.|Analysis was performed using a mixed effect model, with treatment as a fixed effect and participant as a random effect.||114.73|99.33|
72453408|NCT06140290|144429197|EQUIVALENCE|The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. Here, Etrasimod 2mg (Treatment F) with practice session was the test treatment, while Etrasimod 2mg IR tablet (Treatment A) was the reference treatment.|Ratio of Adjusted Geometric Means|91.8|||||TWO_SIDED|90.0|77.76|108.38|||||Ratio (Test/Reference) and its associated 90% CI were expressed as percentages.|Analysis was performed using ANOVA (Analysis of variance) model with treatment as a fixed effect.||108.38|77.76|
72453409|NCT06140290|144429197|EQUIVALENCE|The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. Here, Etrasimod 2mg (Treatment G) without practice session was the test treatment, while Etrasimod 2mg IR tablet (Treatment A) was the reference treatment.|Ratio of Adjusted Geometric Means|102.71|||||TWO_SIDED|90.0|86.33|122.19|||||Ratio (Test/Reference) and its associated 90% CI were expressed as percentages.|Analysis was performed using ANOVA model with treatment as a fixed effect.||122.19|86.33|
72453410|NCT06140290|144429198|EQUIVALENCE|The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. Here, Etrasimod 2mg (Treatment F) with practice session was the test treatment, while Etrasimod 2mg IR tablet (Treatment A) was the reference treatment.|Ratio of Adjusted Geometric Means|86.34|||||TWO_SIDED|90.0|69.42|107.37|||||Ratio (Test/Reference) and its associated 90% CI were expressed as percentages.|Analysis was performed using ANOVA model with treatment as a fixed effect.||107.37|69.42|
72453411|NCT06140290|144429198|EQUIVALENCE|The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. Here, Etrasimod 2mg (Treatment G) without practice session was the test treatment, while Etrasimod 2mg IR tablet (Treatment A) was the reference treatment.|Ratio of Adjusted Geometric Means|97.98|||||TWO_SIDED|90.0|76.99|124.7|||||Ratio (Test/Reference) and its associated 90% CI were expressed as percentages.|Analysis was performed using ANOVA model with treatment as a fixed effect.||124.70|76.99|
72453412|NCT06140290|144429199|EQUIVALENCE|The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. Here, Etrasimod 2mg (Treatment F) with practice session was the test treatment, while Etrasimod 2mg IR tablet (Treatment A) was the reference treatment.|Ratio of Adjusted Geometric Means|88.72|||||TWO_SIDED|90.0|73.1|107.68|||||Ratio (Test/Reference) and its associated 90% CI were expressed as percentages.|Analysis was performed using ANOVA model with treatment as a fixed effect.||107.68|73.10|
72453413|NCT06140290|144429199|EQUIVALENCE|The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. Here, Etrasimod 2mg (Treatment G) without practice session was the test treatment, while Etrasimod 2mg IR tablet (Treatment A) was the reference treatment.|Ratio of Adjusted Geometric Means|97.54|||||TWO_SIDED|90.0|78.74|120.83|||||Ratio (Test/Reference) and its associated 90% CI were expressed as percentages.|Analysis was performed using ANOVA model with treatment as a fixed effect.||120.83|78.74|
72453414|NCT06140290|144429200|EQUIVALENCE|The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. Here, Etrasimod 2mg (Treatment F) with practice session was the test treatment, while Etrasimod 2mg IR tablet (Treatment A) was the reference treatment.|Ratio of Adjusted Geometric Means|94.14|||||TWO_SIDED|90.0|79.01|112.17|||||Ratio (Test/Reference) and its associated 90% CI were expressed as percentages.|Analysis was performed using ANOVA model with treatment as a fixed effect.||112.17|79.01|
72453415|NCT06140290|144429200|EQUIVALENCE|The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. Here, Etrasimod 2mg (Treatment G) without practice session was the test treatment, while Etrasimod 2mg IR tablet (Treatment A) was the reference treatment.|Ratio of Adjusted Geometric Means|103.36|||||TWO_SIDED|90.0|86.04|124.16|||||Ratio (Test/Reference) and its associated 90% CI were expressed as percentages.|Analysis was performed using ANOVA model with treatment as a fixed effect.||124.16|86.04|
72453416|NCT02036970|144429212|SUPERIORITY||Mean Difference (Net)|-1.74||||0.8133|TWO_SIDED|95.0|-16.22|12.74||The p-value comparison is for the difference in the change in 6WMD from baseline at Week 16 for bardoxolone methyl relative to placebo in participants with pulmonary arterial hypertension (PAH).|Mixed Models Analysis||Mean difference (Net) = Bardoxolone methyl - Placebo.|Overall treatment effect in participants with PAH. Mean overall treatment effect across all visits for change from baseline in 6MWD was estimated and compared with placebo through 16 weeks of treatment using mixed-model repeated measures (MMRM), with treatment group, visit, and the interaction between treatment and visit as fixed factors. A compound symmetry covariance matrix was assumed. Data from Wks 4, 8, 12, and 16 used in the model with the change from baseline at Wk16 as primary endpoint.||12.74|-16.22|0.8133
72453417|NCT02036970|144429212|SUPERIORITY||Mean Difference (Net)|-3.17||||0.759|TWO_SIDED|95.0|-23.54|17.2||The p-value comparison is for the difference in the change in 6WMD from baseline at Week 16 for bardoxolone methyl relative to placebo in participants with pulmonary hypertension (PH)|Mixed Models Analysis||Mean difference (Net) = Bardoxolone methyl - Placebo.|Overall treatment effect in participants with PH. Mean overall treatment effect across all visits for change from baseline in 6MWD was estimated \& compared with placebo through 16 wks of treatment using mixed-model repeated measures (MMRM), with treatment group, visit, and the interaction between treatment \& visit as fixed factors. Compound symmetry covariance matrix was assumed. Data from Wks 4, 8, 12, and 16 were used in the model with the change from baseline at Wk 16 as the primary endpoint||17.20|-23.54|0.759
72453418|NCT02298842|144429213|NON_INFERIORITY|The sample size of 60 was chosen to meet the FDA pH requirements that the lower 95% confidence limit on the proportion of platelet test units with pH\> 6.2 will be at least 95%. This will be achieved if zero failures (pH\<=6.2) is seen.|Simple sample proportion|100.0|STANDARD_DEVIATION|0.0|||ONE_SIDED|95.0|95.1||||Exact Binomial Confidence Interval||Estimated proportion is 100%. Hence standard deviation is estimated as 0.|"A success is defined as pH22°C at Day 5 and Day 7 being at least 6.2. A one-sided 95% lower confidence limit will be used to assess the proportion of successes at Day 5 and Day 7. If the lower limit of the one-sided 95% confidence interval exceeds 0.95, the Test product will meet the FDA acceptance criteria."|||95.1|
72499513|NCT01431287|144529521|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.001|STANDARD_ERROR_OF_MEAN|0.013||0.9633|TWO_SIDED|95.0|-0.025|0.026||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.026|-0.025|0.9633
72562283|NCT00108082|144655854|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.33||||0.7651||95.0|-1.83|2.49|||ANCOVA|||The null hypotheses (tested hierarchically) were that the effect of carvedilol CR + lisinopril on LV mass regression was no different than the effect of atenolol + lisinopril, and that the effect of carvedilol CR + lisinopril was no different than the effect of lisinopril + lisinopril. The primary analysis was based on an analysis of covariance (ANCOVA) with a model adjusting for treatment, stratification by hypertension class, region, and baseline value, at a 0.05 level of significance.||2.49|-1.83|0.7651
72562284|NCT00108082|144655854|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.6||||0.1711||95.0|-0.7|3.9|||ANCOVA|||||3.90|-0.70|0.1711
72453419|NCT02298842|144429214|NON_INFERIORITY|The sample size of 60 was chosen to meet the FDA pH requirements that the lower 95% confidence limit on the proportion of platelet test units with pH\> 6.2 will be at least 95%. This will be achieved if zero failures (pH\<=6.2) is seen.|Simple sample proportion|100.0|STANDARD_DEVIATION|0.0|||ONE_SIDED|95.0|95.1||||Exact Bionomial Confidence Interval||Estimated proportion is 100%. Hence standard deviation is estimated as 0.|"A success is defined as pH22°C at Day 5 and Day 7 being at least 6.2. A one-sided 95% lower confidence limit will be used to assess the proportion of successes at Day 5 and Day 7. If the lower limit of the one-sided 95% confidence interval exceeds 0.95, the Test product will meet the FDA acceptance criteria."|||95.1|
72453420|NCT02298842|144429215|NON_INFERIORITY|If the 97.5% upper limit of the confidence interval is less than 0, the null hypothesis will be rejected in favor of the alternative suggesting the Test product is not inferior to the Control product.|Mean Difference (Final Values)|15.099|STANDARD_DEVIATION|5.6367|||ONE_SIDED|97.5||16.738|||||Estimated from an ANCOVA with effects of treatment and subject nested within sequence.|The null hypothesis is that P-selectin's mean difference, Test - 1.25 \* Control, is greater than or equal to 0, and the alternative is that the mean difference is less than 0.||16.738||
72453421|NCT02298842|144429216|NON_INFERIORITY|Higher value is considered to indicate better platelet quality. If the 97.5% lower limit of the confidence interval is greater than 0, the null hypothesis will be rejected in favor of the alternative suggesting the Test product is not inferior to the Control product.|Median Difference (Final Values)|-0.418|STANDARD_DEVIATION|4.5531|||ONE_SIDED|97.5|-1.544||||||Estimated from an ANCOVA with effects of treatment and subject nested within sequence.|The null hypothesis is that ESC's mean difference, Test - 0.8 \* Control, is less than or equal to 0, and the alternative is that the mean difference is greater than 0.|||-1.544|
72453422|NCT02298842|144429217|NON_INFERIORITY|Higher value is considered to indicate better platelet quality. If the 97.5% lower limit of the confidence interval is greater than 0, the null hypothesis will be rejected in favor of the alternative suggesting the Test product is not inferior to the Control product.|Mean Difference (Final Values)|-0.667|STANDARD_DEVIATION|6.7882|||ONE_SIDED|97.5|-2.499||||||Estimated from an ANCOVA with effects of treatment and subject nested within sequence.|The null hypothesis is that HSR's mean difference, Test - 0.8 \* Control, is less than or equal to 0, and the alternative is that the mean difference is greater than 0.|||-2.499|
72453423|NCT02298842|144429218|NON_INFERIORITY|Higher value is considered to indicate better platelet quality. If the 97.5% lower limit of the confidence interval is greater than 0, the null hypothesis will be rejected in favor of the alternative suggesting the Test product is not inferior to the Control product.|Mean Difference (Final Values)|46.1|STANDARD_DEVIATION|23.056|||ONE_SIDED|97.5|40.02||||||Estimated from an ANCOVA with effects of treatment and subject nested within sequence.|The null hypothesis is that Morphology's mean difference, Test - 0.8 \* Control, is less than or equal to 0, and the alternative is that the mean difference is greater than 0.|||40.020|
72453424|NCT02298842|144429219|NON_INFERIORITY|Lower value is considered to indicate better platelet quality. If the 97.5% upper limit of the confidence interval is less than 0, the null hypothesis will be rejected in favor of the alternative suggesting the Test product is not inferior to the Control product.|Mean Difference (Final Values)|12.314|STANDARD_DEVIATION|6.0422|||ONE_SIDED|97.5||13.981|||||Estimated from an ANCOVA with effects of treatment and subject nested within sequence.|The null hypothesis is that P-selection's mean difference, Test - 1.25 \* Control, is greater or equal to 0, and the alternative is that the mean difference is less than 0.||13.981||
72453425|NCT02298842|144429220|NON_INFERIORITY|Higher value is considered to indicate better platelet quality. If the 97.5% lower limit of the confidence interval is greater than 0, the null hypothesis will be rejected in favor of the alternative suggesting the Test product is not inferior to the Control product.|Mean Difference (Final Values)|-3.042|STANDARD_DEVIATION|5.422|||ONE_SIDED|97.5|-4.407||||||Estimated from an ANCOVA with effects of treatment and subject nested within sequence.|The null hypothesis is that ESC's mean difference, Test - 0.8 \* Control, is less than or equal to 0, and the alternative is that the mean difference is greater than 0.|||-4.407|
72453426|NCT02298842|144429221|NON_INFERIORITY|Higher value is considered to indicate better platelet quality. If the 97.5% lower limit of the confidence interval is greater than 0, the null hypothesis will be rejected in favor of the alternative suggesting the Test product is not inferior to the Control product.|Mean Difference (Final Values)|-2.389|STANDARD_DEVIATION|9.0544|||ONE_SIDED|97.5|-4.915||||||Estimated from an ANCOVA with effects of treatment and subject nested within sequence.|The null hypothesis is that HSR's mean difference, Test - 0.8 \* Control, is less than or equal to 0, and the alternative is that the mean difference is greater than 0.|||-4.915|
72562285|NCT00955552|144655868|NON_INFERIORITY|Non-inferiority test of Ártico vs Cosamin DS® regarding the decrease of pain scale (VAS) in the PP population (N = 86).|||||<|0.05||||||For numeric variables Test -t student or ANOVA will be used. It will be considered statistically significant P-value less than 0,05.|t-test, 1 sided|||||||<0.05
72562286|NCT00412737|144655896|SUPERIORITY_OR_OTHER||Relative Risk Reduction|0.283||||0.772|TWO_SIDED|95.0|-2.3|4.1|||Fisher Exact||Relative Risk Reduction = (1.0 - Relative Risk).|The null hypothesis tested was that there was no difference between the proportions of participants who met the primary endpoint in the two treatment groups.||4.1|-2.3|0.772
72562287|NCT00412737|144655897|SUPERIORITY_OR_OTHER||Relative Risk Reduction|0.37||||0.534|TWO_SIDED|95.0|-2.1|4.5|||Fisher Exact||Relative Risk Reduction = (1.0 - Relative Risk).|||4.5|-2.1|0.534
72453427|NCT02298842|144429222|NON_INFERIORITY|Higher value is considered to indicate better platelet quality. If the 97.5% lower limit of the confidence interval is greater than 0, the null hypothesis will be rejected in favor of the alternative suggesting the Test product is not inferior to the Control product.|Mean Difference (Final Values)|43.8|STANDARD_DEVIATION|26.05|||ONE_SIDED|97.5|36.821||||||Estimated from an ANCOVA with effects of treatment and subject nested within sequence.|The null hypothesis is that Morphology's mean difference, Test - 0.8 \* Control, is less than or equal to 0, and the alternative is that the mean difference is greater than 0.|||36.821|
72562288|NCT00412737|144655898|SUPERIORITY_OR_OTHER||Relative Risk Reduction|0.431||||0.381|TWO_SIDED|95.0|-1.7|4.6|||Fisher Exact||Relative Risk Reduction = (1.0 - Relative Risk).|||4.6|-1.7|0.381
72562289|NCT00412737|144655899|SUPERIORITY_OR_OTHER||Relative Risk Reduction|0.713|||||TWO_SIDED|95.0|-0.6|5.2|||||Relative Risk Reduction = (1.0 - Relative Risk).|||5.2|-0.6|
72562290|NCT00412737|144655900|SUPERIORITY_OR_OTHER||Slope|0.858|||||TWO_SIDED|95.0|0.1|5.7|||||Relative Risk Reduction = (1.0 - Relative Risk).|||5.7|0.1|
72562291|NCT00412737|144655901|SUPERIORITY_OR_OTHER||Relative Risk Reduction|0.372|||||TWO_SIDED|95.0|-1.9|4.6|||||Relative Risk Reduction = (1.0 - Relative Risk).|||4.6|-1.9|
72562292|NCT00412737|144655902|SUPERIORITY_OR_OTHER||Relative Risk Reduction|0.502|||||TWO_SIDED|95.0|-1.4|5.1|||||Relative Risk Reduction = (1.0 - Relative Risk).|||5.1|-1.4|
72562293|NCT00513617|144655925|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1254|STANDARD_ERROR_OF_MEAN|0.0705||0.08||||||Alpha was set at 0.05|Mixed Models Analysis|Null is tested using the F-test from a random effects longitudinal mixed model, with treatment and baseline measurement as fixed effects.|Placebo was subtracted from the Low dose|Null hypothesis is no difference between high vs. placebo and low vs. placebo in change from baseline at Week 12 post-randomization. Separate models were fit for pediatric and adult populations, however the combined population is entered here.||||0.080
72562294|NCT00513617|144655925|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.098|STANDARD_ERROR_OF_MEAN|0.0713||0.133||||||Alpha was set at 0.05|Mixed Models Analysis|Null is tested using the F-test from a random effects longitudinal mixed model, with treatment and baseline measurement as fixed effects.|Placebo was subtracted from High dose|Null hypothesis is no difference between high vs. placebo and low vs. placebo in change from baseline at Week 12 post-randomization. Separate models were fit for pediatric and adult populations, however the combined population is entered here.||||0.133
72562295|NCT00513617|144655927|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1826|STANDARD_ERROR_OF_MEAN|0.0713||0.915||||||Alpha was set at 0.5|Mixed Models Analysis|Null is tested using the F-test from a random effects longitudinal mixed model, with treatment and baseline measurement as fixed effects.|Placebo subtracted from Low dose|Null hypothesis is no difference between high vs. placebo and low vs. placebo in change from baseline at Week 12 post-randomization. Separate models were fit for pediatric and adult populations, however the combined population is entered here.||||0.915
72562296|NCT00513617|144655927|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.3582|STANDARD_ERROR_OF_MEAN|4.1047||0.918||||||Alpha was set at 0.05|Mixed Models Analysis|Null is tested using the F-test from a random effects longitudinal mixed model, with treatment and baseline measurement as fixed effects.|Placebo subtracted from High dose|Null hypothesis is no difference between high vs. placebo and low vs. placebo in change from baseline at Week 12 post-randomization. Separate models were fit for pediatric and adult populations, however the combined population is entered here.||||0.918
72562297|NCT00513617|144655928|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.7867|STANDARD_ERROR_OF_MEAN|1.1101||0.015||||||Alpha was set at 0.05|Mixed Models Analysis|Null is tested using the F-test from a random effects longitudinal mixed model, with treatment and baseline measurement as fixed effects.|Placebo subtracted from Low dose|Null hypothesis is no difference between high vs. placebo and low vs. placebo in change from baseline at Week 12 post-randomization. Separate models were fit for pediatric and adult populations, however the combined population is entered here.||||0.015
72562298|NCT00513617|144655928|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.5213|STANDARD_ERROR_OF_MEAN|1.1553||0.557||||||Alpha was set at 0.05|Mixed Models Analysis|Null is tested using the F-test from a random effects longitudinal mixed model, with treatment and baseline measurement as fixed effects.|Placebo subtracted from High dose|Null hypothesis is no difference between high vs. placebo and low vs. placebo in change from baseline at Week 12 post-randomization. Separate models were fit for pediatric and adult populations, however the combined population is entered here.||||0.557
72562299|NCT00809965|144655932|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.84||||0.02|TWO_SIDED|95.0|0.72|0.97|||Log Rank||Based upon the Cox proportional hazards model|||0.97|0.72|0.020
72453428|NCT02722434|144429268|SUPERIORITY|||||||0.1228|||||||Chi-squared|||||||0.1228
72453429|NCT02722434|144429269|SUPERIORITY|||||||0.004|||||||Fisher Exact|||||||0.004
72562300|NCT00809965|144655932|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.85||||0.028|TWO_SIDED|95.0|0.73|0.98|||Log Rank||Based upon the Cox proportional hazards model|||0.98|0.73|0.028
72562301|NCT00809965|144655933|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.83||||0.016|TWO_SIDED|95.0|0.72|0.97|||Log Rank||Based on the Cox proportional hazards model|||0.97|0.72|0.016
72562302|NCT00809965|144655933|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.84||||0.025|TWO_SIDED|95.0|0.73|0.98|||Log Rank||Based on the Cox proportional hazards model|||0.98|0.73|0.025
72562303|NCT00809965|144655934|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.93||||0.32|TWO_SIDED|95.0|0.81|1.07|||Log Rank||Based upon the Cox proportional hazards model|||1.07|0.81|0.320
72562304|NCT00809965|144655934|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.95||||0.508|TWO_SIDED|95.0|0.83|1.1|||Log Rank||Based upon the Cox proportional hazards model|||1.10|0.83|0.508
72562305|NCT00809965|144655935|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.92||||0.185|TWO_SIDED|95.0|0.8|1.04|||Log Rank||Based upon the Cox proportional hazards model|||1.04|0.80|0.185
72562306|NCT00809965|144655935|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.89||||0.081|TWO_SIDED|95.0|0.78|1.01|||Log Rank||Based upon the Cox proportional hazards model|||1.01|0.78|0.081
72453430|NCT02722434|144429270|SUPERIORITY|||||||0.79|||||||Wilcoxon (Mann-Whitney)|||Sensory Subscale||||0.79
72453431|NCT02722434|144429270|SUPERIORITY|||||||0.43|||||||Wilcoxon (Mann-Whitney)|||Motor Subscale||||0.43
72453432|NCT02722434|144429270|SUPERIORITY|||||||0.97|||||||Wilcoxon (Mann-Whitney)|||Autonomic Subscale||||0.97
72453433|NCT03849937|144429295|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<.001
72453434|NCT03849937|144429295|SUPERIORITY|||||||0.091||||||Time 1 to Time 2|t-test, 2 sided|||||||.091
72453435|NCT03849937|144429295|SUPERIORITY||||||<|0.001||||||Time 2 to Time 3|t-test, 2 sided|||||||<.001
72453436|NCT03849937|144429296|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Effective Communication||||<.001
72453437|NCT03849937|144429296|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Appropriate Communication||||<.001
72453438|NCT03849937|144429296|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Recognizes elderspeak||||<.001
72453439|NCT03849937|144429296|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Recognizes person-centered communication||||<.001
72453440|NCT00857766|144429350|SUPERIORITY_OR_OTHER||Least squares (LS) mean difference|-0.42||||0.065||95.0|-0.88|0.03|||ANCOVA||LS mean difference is calculated as FSC 250/50 minus Placebo and is adjusted for treatment, investigator, sex, smoking status, age, body mass index (BMI), waist circumference, treatment by sex interaction, age by BMI interaction, and baseline value.|||0.03|-0.88|0.065
72453441|NCT00857766|144429351|SUPERIORITY_OR_OTHER||Least squares analysis|-0.6|STANDARD_ERROR_OF_MEAN|0.86||0.469||95.0|-2.3|1.1|||ANCOVA|||||1.1|-2.3|0.469
72453442|NCT00857766|144429352|SUPERIORITY_OR_OTHER||Least squares analysis|127.0|STANDARD_ERROR_OF_MEAN|35.5|<|0.001||95.0|57.0|197.0|||ANCOVA|||||197|57|<0.001
72453443|NCT01536093|144429374|SUPERIORITY_OR_OTHER|||||||0.006|||||||Wilcoxon (Mann-Whitney)|||||||0.006
72453444|NCT01536093|144429375|SUPERIORITY_OR_OTHER|||||||0.043|||||||Wilcoxon (Mann-Whitney)|||||||0.043
72453445|NCT01536093|144429376|SUPERIORITY_OR_OTHER|||||||0.032|||||||Wilcoxon (Mann-Whitney)|||||||0.032
72453446|NCT01536093|144429377|SUPERIORITY_OR_OTHER|||||||0.038|||||||Wilcoxon (Mann-Whitney)|||||||0.038
72499514|NCT01431287|144529521|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.063|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|0.038|0.088||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.088|0.038|<0.0001
72499515|NCT01431287|144529521|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.029|STANDARD_ERROR_OF_MEAN|0.013||0.025|TWO_SIDED|95.0|0.004|0.054||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.054|0.004|0.0250
72499516|NCT01431287|144529521|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.002|STANDARD_ERROR_OF_MEAN|0.013||0.8949|TWO_SIDED|95.0|-0.023|0.027||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.027|-0.023|0.8949
72499517|NCT01431287|144529521|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.027|STANDARD_ERROR_OF_MEAN|0.013||0.0351|TWO_SIDED|95.0|0.002|0.052||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.052|0.002|0.0351
72453447|NCT01536093|144429378|SUPERIORITY_OR_OTHER|||||||0.01|||||||Wilcoxon (Mann-Whitney)|||||||0.010
72453448|NCT01536093|144429379|SUPERIORITY_OR_OTHER|||||||0.013|||||||Wilcoxon (Mann-Whitney)|||||||0.013
72453449|NCT05485805|144429537|OTHER||Geometric LS means|-5.95|||=|0.004|TWO_SIDED|95.0|-9.946|-1.954|||ANCOVA|||||-1.954|-9.946|= 0.004
72453450|NCT05485805|144429537|OTHER||Geometric LS means|6.161|||=|0.003|TWO_SIDED|95.0|2.161|10.161|||ANCOVA|||||10.161|2.161|= 0.003
72453451|NCT05485805|144429537|OTHER||Geometric LS means|25.936|||<|0.001|TWO_SIDED|95.0|20.317|31.556|||ANCOVA|||||31.556|20.317|< 0.001
72453452|NCT05485805|144429537|OTHER||Geometric LS means|-3.476|||=|0.325|TWO_SIDED|95.0|-10.41|3.457|||ANCOVA|||||3.457|-10.41|= 0.325
72453453|NCT05485805|144429537|OTHER||Geometric LS means|0.211|||=|0.918|TWO_SIDED|95.0|-3.798|4.22|||ANCOVA|||||4.22|-3.798|= 0.918
72453454|NCT05485805|144429537|OTHER||Geometric LS means|32.097|||<|0.001|TWO_SIDED|95.0|26.484|37.71|||ANCOVA|||||37.71|26.484|< 0.001
72453455|NCT05485805|144429537|OTHER||Geometric LS means|22.46|||<|0.001|TWO_SIDED|95.0|16.753|28.166|||ANCOVA|||||28.166|16.753|< 0.001
72453456|NCT05485805|144429537|OTHER||Geometric LS means|26.147|||<|0.001|TWO_SIDED|95.0|20.529|31.765|||ANCOVA|||||31.765|20.529|< 0.001
72453457|NCT05485805|144429537|OTHER||Geometric LS means|28.62|||<|0.001|TWO_SIDED|95.0|22.921|34.32|||ANCOVA|||||34.32|22.921|< 0.001
72453458|NCT05485805|144429537|OTHER||Geometric LS means|22.671|||<|0.001|TWO_SIDED|95.0|16.966|28.375|||ANCOVA|||||28.375|16.966|< 0.001
72453459|NCT05485805|144429538|OTHER||Geometric LS means|-1.602|||<|0.001|TWO_SIDED|95.0|-2.548|-0.656|||ANCOVA|||0-2 hours post-dose||-0.656|-2.548|< 0.001
72453460|NCT05485805|144429538|OTHER||Geometric LS means|0.976|||=|0.043|TWO_SIDED|95.0|0.029|1.923|||ANCOVA|||0-2 hours post-dose||1.923|0.029|= 0.043
72453461|NCT05485805|144429538|OTHER||Geometric LS means|6.097|||<|0.001|TWO_SIDED|95.0|4.766|7.427|||ANCOVA|||0-2 hours post-dose||7.427|4.766|< 0.001
72453462|NCT05485805|144429538|OTHER||Geometric LS means|0.31|||=|0.711|TWO_SIDED|95.0|-1.332|1.951|||ANCOVA|||0-2 hours post-dose||1.951|-1.332|= 0.711
72453463|NCT05485805|144429538|OTHER||Geometric LS means|-0.626|||=|0.196|TWO_SIDED|95.0|-1.575|0.323|||ANCOVA|||0-2 hours post-dose||0.323|-1.575|= 0.196
72453464|NCT05485805|144429538|OTHER||Geometric LS means|7.073|||<|0.001|TWO_SIDED|95.0|5.744|8.402|||ANCOVA|||0-2 hours post-dose||8.402|5.744|< 0.001
72453465|NCT05485805|144429538|OTHER||Geometric LS means|6.406|||<|0.001|TWO_SIDED|95.0|5.055|7.757|||ANCOVA|||0-2 hours post-dose||7.757|5.055|< 0.001
72453466|NCT05485805|144429538|OTHER||Geometric LS means|5.471|||<|0.001|TWO_SIDED|95.0|4.141|6.801|||ANCOVA|||0-2 hours post-dose||6.801|4.141|< 0.001
72453467|NCT05485805|144429538|OTHER||Geometric LS means|7.383|||<|0.001|TWO_SIDED|95.0|6.033|8.732|||ANCOVA|||0-2 hours post-dose||8.732|6.033|< 0.001
72453468|NCT05485805|144429538|OTHER||Geometric LS means|5.78|||<|0.001|TWO_SIDED|95.0|4.43|7.131|||ANCOVA|||0-2 hours post-dose||7.131|4.43|< 0.001
72499518|NCT01431287|144529522|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.08|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|0.055|0.105||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.105|0.055|<0.0001
72453469|NCT05485805|144429539|OTHER||Geometric LS means|-0.586|||<|0.001|TWO_SIDED|95.0|-0.903|-0.269|||ANCOVA|||0-2 hours post-dose||-0.269|-0.903|< 0.001
72499519|NCT01431287|144529522|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.047|STANDARD_ERROR_OF_MEAN|0.013||0.0002|TWO_SIDED|95.0|0.022|0.073||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.073|0.022|0.0002
72499520|NCT01431287|144529522|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.076|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|0.051|0.101||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.101|0.051|<0.0001
72499521|NCT01431287|144529522|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.061|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|0.036|0.086||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.086|0.036|<0.0001
72499522|NCT01431287|144529522|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.044|STANDARD_ERROR_OF_MEAN|0.013||0.0007|TWO_SIDED|95.0|0.018|0.069||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.069|0.018|0.0007
72499523|NCT01431287|144529522|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.004|STANDARD_ERROR_OF_MEAN|0.013||0.7755|TWO_SIDED|95.0|-0.022|0.029||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.029|-0.022|0.7755
72453470|NCT05485805|144429539|OTHER||Geometric LS means|0.454|||=|0.005|TWO_SIDED|95.0|0.136|0.771|||ANCOVA|||0-2 hours post-dose||0.771|0.136|= 0.005
72453471|NCT05485805|144429539|OTHER||Geometric LS means|2.369|||<|0.001|TWO_SIDED|95.0|1.923|2.815|||ANCOVA|||0-2 hours post-dose||2.815|1.923|< 0.001
72499524|NCT01431287|144529522|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.065|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|0.039|0.09||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.090|0.039|<0.0001
72499525|NCT01431287|144529522|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.032|STANDARD_ERROR_OF_MEAN|0.013||0.0118|TWO_SIDED|95.0|0.007|0.058||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.058|0.007|0.0118
72499526|NCT01431287|144529522|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.015|STANDARD_ERROR_OF_MEAN|0.013||0.2416|TWO_SIDED|95.0|-0.01|0.04||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.040|-0.010|0.2416
72453472|NCT05485805|144429539|OTHER||Geometric LS means|-0.169|||=|0.548|TWO_SIDED|95.0|-0.719|0.382|||ANCOVA|||0-2 hours post-dose||0.382|-0.719|= 0.548
72453473|NCT05485805|144429539|OTHER||Geometric LS means|-0.132|||=|0.415|TWO_SIDED|95.0|-0.451|0.186|||ANCOVA|||0-2 hours post-dose||0.186|-0.451|= 0.415
72499527|NCT01431287|144529522|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.017|STANDARD_ERROR_OF_MEAN|0.013||0.1792|TWO_SIDED|95.0|-0.008|0.043||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.043|-0.008|0.1792
72562307|NCT00809965|144655936|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.84||||0.011|TWO_SIDED|95.0|0.73|0.96|||Log Rank||Based upon the Cox proportional hazards model|||0.96|0.73|0.011
72453474|NCT05485805|144429539|OTHER||Geometric LS means|2.823|||<|0.001|TWO_SIDED|95.0|2.377|3.268|||ANCOVA|||0-2 hours post-dose||3.268|2.377|< 0.001
72453475|NCT05485805|144429539|OTHER||Geometric LS means|2.201|||<|0.001|TWO_SIDED|95.0|1.748|2.654|||ANCOVA|||0-2 hours post-dose||2.654|1.748|< 0.001
72453476|NCT05485805|144429539|OTHER||Geometric LS means|2.237|||<|0.001|TWO_SIDED|95.0|1.791|2.683|||ANCOVA|||0-2 hours post-dose||2.683|1.791|< 0.001
72453477|NCT05485805|144429539|OTHER||Geometric LS means|2.654|||<|0.001|TWO_SIDED|95.0|2.202|3.106|||ANCOVA|||0-2 hours post-dose||3.106|2.202|< 0.001
72453478|NCT05485805|144429539|OTHER||Geometric LS means|2.068|||<|0.001|TWO_SIDED|95.0|1.615|2.521|||ANCOVA|||0-2 hours post-dose||2.521|1.615|< 0.001
72453479|NCT05485805|144429539|OTHER||Geometric LS means|-1.338|||<|0.001|TWO_SIDED|95.0|-2.133|-0.542|||ANCOVA|||0-4 hours post-dose||-0.542|-2.133|< 0.001
72453480|NCT05485805|144429539|OTHER||Geometric LS means|1.016|||=|0.012|TWO_SIDED|95.0|0.22|1.813|||ANCOVA|||0-4 hours post-dose||1.813|0.22|= 0.012
72453481|NCT05485805|144429539|OTHER||Geometric LS means|5.982|||<|0.001|TWO_SIDED|95.0|4.864|7.101|||ANCOVA|||0-4 hours post-dose||7.101|4.864|< 0.001
72453482|NCT05485805|144429539|OTHER||Geometric LS means|-1.048|||=|0.136|TWO_SIDED|95.0|-2.428|0.332|||ANCOVA|||0-4 hours post-dose||0.332|-2.428|= 0.136
72453483|NCT05485805|144429539|OTHER||Geometric LS means|-0.321|||=|0.43|TWO_SIDED|95.0|-1.119|0.477|||ANCOVA|||0-4 hours post-dose||0.477|-1.119|= 0.43
72499528|NCT01431287|144529523|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.1|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|0.074|0.125||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.125|0.074|<0.0001
72499529|NCT01431287|144529523|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.059|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|0.033|0.084||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.084|0.033|<0.0001
72499530|NCT01431287|144529523|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.082|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|0.057|0.107||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.107|0.057|<0.0001
72453484|NCT05485805|144429539|OTHER||Geometric LS means|6.999|||<|0.001|TWO_SIDED|95.0|5.881|8.116|||ANCOVA|||0-4 hours post-dose||8.116|5.881|< 0.001
72453485|NCT05485805|144429539|OTHER||Geometric LS means|4.934|||<|0.001|TWO_SIDED|95.0|3.798|6.07|||ANCOVA|||0-4 hours post-dose||6.07|3.798|< 0.001
72453486|NCT05485805|144429539|OTHER||Geometric LS means|5.661|||<|0.001|TWO_SIDED|95.0|4.543|6.779|||ANCOVA|||0-4 hours post-dose||6.779|4.543|< 0.001
72453487|NCT05485805|144429539|OTHER||Geometric LS means|5.951|||<|0.001|TWO_SIDED|95.0|4.816|7.085|||ANCOVA|||0-4 hours post-dose||7.085|4.816|< 0.001
72453488|NCT05485805|144429539|OTHER||Geometric LS means|4.613|||<|0.001|TWO_SIDED|95.0|3.478|5.749|||ANCOVA|||0-4 hours post-dose||5.749|3.478|< 0.001
72453489|NCT05485805|144429539|OTHER||Geometric LS means|-1.963|||=|0.003|TWO_SIDED|95.0|-3.254|-0.673|||ANCOVA|||0-6 hours post-dose||-0.673|-3.254|= 0.003
72453490|NCT05485805|144429539|OTHER||Geometric LS means|1.641|||=|0.013|TWO_SIDED|95.0|0.35|2.933|||ANCOVA|||0-6 hours post-dose||2.933|0.35|= 0.013
72453491|NCT05485805|144429539|OTHER||Geometric LS means|9.191|||<|0.001|TWO_SIDED|95.0|7.377|11.006|||ANCOVA|||0-6 hours post-dose||11.006|7.377|< 0.001
72453492|NCT05485805|144429539|OTHER||Geometric LS means|-1.642|||=|0.15|TWO_SIDED|95.0|-3.881|0.597|||ANCOVA|||0-6 hours post-dose||0.597|-3.881|= 0.15
72453493|NCT05485805|144429539|OTHER||Geometric LS means|-0.322|||=|0.625|TWO_SIDED|95.0|-1.617|0.972|||ANCOVA|||0-6 hours post-dose||0.972|-1.617|= 0.625
72453494|NCT05485805|144429539|OTHER||Geometric LS means|10.833|||<|0.001|TWO_SIDED|95.0|9.02|12.645|||ANCOVA|||0-6 hours post-dose||12.645|9.02|< 0.001
72453495|NCT05485805|144429539|OTHER||Geometric LS means|7.55|||<|0.001|TWO_SIDED|95.0|5.707|9.392|||ANCOVA|||0-6 hours post-dose||9.392|5.707|< 0.001
72453496|NCT05485805|144429539|OTHER||Geometric LS means|8.869|||<|0.001|TWO_SIDED|95.0|7.055|10.683|||ANCOVA|||0-6 hours post-dose||10.683|7.055|< 0.001
72453497|NCT05485805|144429539|OTHER||Geometric LS means|9.191|||<|0.001|TWO_SIDED|95.0|7.351|11.031|||ANCOVA|||0-6 hours post-dose||11.031|7.351|< 0.001
72453498|NCT05485805|144429539|OTHER||Geometric LS means|7.228|||<|0.001|TWO_SIDED|95.0|5.386|9.07|||ANCOVA|||0-6 hours post-dose||9.07|5.386|< 0.001
72453499|NCT05485805|144429539|OTHER||Geometric LS means|-2.398|||=|0.009|TWO_SIDED|95.0|-4.185|-0.61|||ANCOVA|||0-8 hours post-dose||-0.61|-4.185|= 0.009
72453500|NCT05485805|144429539|OTHER||Geometric LS means|2.4|||=|0.009|TWO_SIDED|95.0|0.61|4.189|||ANCOVA|||0-8 hours post-dose||4.189|0.61|= 0.009
72453501|NCT05485805|144429539|OTHER||Geometric LS means|11.898|||<|0.001|TWO_SIDED|95.0|9.384|14.412|||ANCOVA|||0-8 hours post-dose||14.412|9.384|< 0.001
72453502|NCT05485805|144429539|OTHER||Geometric LS means|-2.225|||=|0.159|TWO_SIDED|95.0|-5.327|0.877|||ANCOVA|||0-8 hours post-dose||0.877|-5.327|= 0.159
72453503|NCT05485805|144429539|OTHER||Geometric LS means|0.002|||=|0.998|TWO_SIDED|95.0|-1.792|1.795|||ANCOVA|||0-8 hours post-dose||1.795|-1.792|= 0.998
72453504|NCT05485805|144429539|OTHER||Geometric LS means|14.298|||<|0.001|TWO_SIDED|95.0|11.787|16.809|||ANCOVA|||0-8 hours post-dose||16.809|11.787|< 0.001
72453505|NCT05485805|144429539|OTHER||Geometric LS means|9.673|||<|0.001|TWO_SIDED|95.0|7.12|12.226|||ANCOVA|||0-8 hours post-dose||12.226|7.12|< 0.001
72453506|NCT05485805|144429539|OTHER||Geometric LS means|11.9|||<|0.001|TWO_SIDED|95.0|9.387|14.413|||ANCOVA|||0-8 hours post-dose||14.413|9.387|< 0.001
72453507|NCT05485805|144429539|OTHER||Geometric LS means|12.073|||<|0.001|TWO_SIDED|95.0|9.523|14.623|||ANCOVA|||0-8 hours post-dose||14.623|9.523|< 0.001
72453508|NCT05485805|144429539|OTHER||Geometric LS means|9.675|||<|0.001|TWO_SIDED|95.0|7.123|12.227|||ANCOVA|||0-8 hours post-dose||12.227|7.123|< 0.001
72453509|NCT05485805|144429539|OTHER||Geometric LS means|-2.949|||=|0.043|TWO_SIDED|95.0|-5.803|-0.095|||ANCOVA|||0-12 hours post-dose||-0.095|-5.803|= 0.043
72453510|NCT05485805|144429539|OTHER||Geometric LS means|3.694|||=|0.011|TWO_SIDED|95.0|0.837|6.55|||ANCOVA|||0-12 hours post-dose||6.55|0.837|= 0.011
72453511|NCT05485805|144429539|OTHER||Geometric LS means|16.504|||<|0.001|TWO_SIDED|95.0|12.49|20.517|||ANCOVA|||0-12 hours post-dose||20.517|12.49|< 0.001
72453512|NCT05485805|144429539|OTHER||Geometric LS means|-3.437|||=|0.173|TWO_SIDED|95.0|-8.389|1.515|||ANCOVA|||0-12 hours post-dose||1.515|-8.389|= 0.173
72453513|NCT05485805|144429539|OTHER||Geometric LS means|0.744|||=|0.61|TWO_SIDED|95.0|-2.119|3.608|||ANCOVA|||0-12 hours post-dose||3.608|-2.119|= 0.61
72453514|NCT05485805|144429539|OTHER||Geometric LS means|20.197|||<|0.001|TWO_SIDED|95.0|16.189|24.206|||ANCOVA|||0-12 hours post-dose||24.206|16.189|< 0.001
72453515|NCT05485805|144429539|OTHER||Geometric LS means|13.067|||<|0.001|TWO_SIDED|95.0|8.992|17.143|||ANCOVA|||0-12 hours post-dose||17.143|8.992|< 0.001
72453516|NCT05485805|144429539|OTHER||Geometric LS means|17.248|||<|0.001|TWO_SIDED|95.0|13.236|21.261|||ANCOVA|||0-12 hours post-dose||21.261|13.236|< 0.001
72453517|NCT05485805|144429539|OTHER||Geometric LS means|16.761|||<|0.001|TWO_SIDED|95.0|12.69|20.831|||ANCOVA|||0-12 hours post-dose||20.831|12.69|< 0.001
72453518|NCT05485805|144429539|OTHER||Geometric LS means|13.812|||<|0.001|TWO_SIDED|95.0|9.738|17.886|||ANCOVA|||0-12 hours post-dose||17.886|9.738|< 0.001
72453519|NCT05485805|144429539|OTHER||Geometric LS means|-2.312|||=|0.473|TWO_SIDED|95.0|-8.635|4.011|||ANCOVA|||0-24 hours post-dose||4.011|-8.635|= 0.473
72453520|NCT05485805|144429539|OTHER||Geometric LS means|27.08|||<|0.001|TWO_SIDED|95.0|18.188|35.973|||ANCOVA|||0-24 hours post-dose||35.973|18.188|< 0.001
72453521|NCT05485805|144429539|OTHER||Geometric LS means|-6.928|||=|0.215|TWO_SIDED|95.0|-17.9|4.044|||ANCOVA|||0-24 hours post-dose||4.044|-17.9|= 0.215
72453522|NCT05485805|144429539|OTHER||Geometric LS means|2.468|||=|0.445|TWO_SIDED|95.0|-3.876|8.813|||ANCOVA|||0-24 hours post-dose||8.813|-3.876|= 0.445
72453523|NCT05485805|144429539|OTHER||Geometric LS means|20.152|||<|0.001|TWO_SIDED|95.0|11.122|29.183|||ANCOVA|||0-24 hours post-dose||29.183|11.122|< 0.001
72453524|NCT05485805|144429539|OTHER||Geometric LS means|24.933|||<|0.001|TWO_SIDED|95.0|15.914|33.952|||ANCOVA|||0-24 hours post-dose||33.952|15.914|< 0.001
72453525|NCT05485805|144429539|OTHER||Geometric LS means|22.621|||<|0.001|TWO_SIDED|95.0|13.594|31.648|||ANCOVA|||0-24 hours post-dose||31.648|13.594|< 0.001
72562308|NCT00809965|144655936|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.88||||0.07|TWO_SIDED|95.0|0.78|1.01|||Log Rank||Based upon the Cox proportional hazards model|||1.01|0.78|0.070
72453526|NCT05485805|144429540|OTHER||||||=|0.963|||||||ANCOVA|||||||= 0.963
72453527|NCT05485805|144429540|OTHER||||||=|0.118|||||||ANCOVA|||||||= 0.118
72562309|NCT00112294|144655988|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.902||||0.2358|TWO_SIDED|95.0|0.761|1.069||Since only 1 primary comparison was conducted, no adjustment for multiple comparisons was needed.|Log Rank||The hazard ratio of C/T/C to T/C was estimated by means of a stratified Cox's proportional hazard model, with treatment as the single covariate.|Confidence intervals calculated using Brookmeyer and Crowley method. Primary analysis was comparison of PFS between arms performed by 2-sided alpha=0.05 level, log-rank test, stratified by ECOG PS (0/1) and intended on-study taxane (docetaxel or paclitaxel). Null hypothesis was that PFS was equal in both groups. Power calculations indicated that \>=510 events (IRRC progressions/deaths) would lead to \>=90% power at the 5% level for rejecting the null hypothesis, given a true hazard ratio of 0.75.||1.069|0.761|0.2358
72562310|NCT00112294|144655989|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.675||||0.0066|TWO_SIDED|95.0|1.152|2.436|||Cochran-Mantel-Haenszel||The odds ratio is presented for C/T/C to T/C.|The 2 groups were compared by means of a Cochran-Mantel-Haenszel (CMH) (alpha = 0.05 level) test stratified by ECOG PS (0 or 1) and intended on-study taxane (paclitaxel, docetaxel), as recorded at the time of randomization.||2.436|1.152|0.0066
72562311|NCT00112294|144655990|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.265||||0.1501|TWO_SIDED|95.0|0.918|1.741|||Cochran-Mantel-Haenszel||The odds ratio is presented for C/T/C to T/C.|The 2 groups were compared by means of a CMH (alpha = 0.05 level) test stratified by ECOG PS (0 or 1) and intended on-study taxane (paclitaxel, docetaxel), as recorded at the time of randomization.||1.741|0.918|0.1501
72453528|NCT05485805|144429540|OTHER||||||<|0.001|||||||ANCOVA|||||||< 0.001
72453529|NCT05485805|144429540|OTHER||||||=|0.244|||||||ANCOVA|||||||= 0.244
72453530|NCT05485805|144429540|OTHER||||||=|0.139|||||||ANCOVA|||||||= 0.139
72453531|NCT05485805|144429540|OTHER||||||<|0.001|||||||ANCOVA|||||||< 0.001
72453532|NCT05485805|144429540|OTHER||||||<|0.001|||||||ANCOVA|||||||< 0.001
72453533|NCT05485805|144429540|OTHER||||||<|0.001|||||||ANCOVA|||||||< 0.001
72453534|NCT05485805|144429540|OTHER||||||<|0.001|||||||ANCOVA|||||||< 0.001
72453535|NCT05485805|144429540|OTHER||||||<|0.001|||||||ANCOVA|||||||< 0.001
72453536|NCT05485805|144429542|OTHER||||||=|0.647|||||||ANCOVA|||||||= 0.647
72453537|NCT05485805|144429542|OTHER||||||=|0.714|||||||ANCOVA|||||||= 0.714
72453538|NCT05485805|144429542|OTHER||||||=|0.065|||||||ANCOVA|||||||= 0.065
72453539|NCT05485805|144429542|OTHER||||||=|0.742|||||||ANCOVA|||||||= 0.742
72453540|NCT05485805|144429542|OTHER||||||<|0.001|||||||ANCOVA|||||||< 0.001
72453541|NCT05485805|144429542|OTHER||||||<|0.001|||||||ANCOVA|||||||< 0.001
72453542|NCT05485805|144429542|OTHER||||||<|0.001|||||||ANCOVA|||||||< 0.001
72453543|NCT05485805|144429542|OTHER||||||<|0.001|||||||ANCOVA|||||||< 0.001
72453544|NCT05485805|144429542|OTHER||||||<|0.001|||||||ANCOVA|||||||< 0.001
72453545|NCT05485805|144429543|OTHER||||||=|0.162|||||||ANCOVA|||||||= 0.162
72453546|NCT05485805|144429543|OTHER||||||=|0.319|||||||ANCOVA|||||||= 0.319
72453547|NCT05485805|144429543|OTHER||||||<|0.001|||||||ANCOVA|||||||< 0.001
72453548|NCT05485805|144429543|OTHER||||||=|0.343|||||||ANCOVA|||||||= 0.343
72453549|NCT05485805|144429543|OTHER||||||<|0.001|||||||ANCOVA|||||||< 0.001
72453550|NCT05485805|144429543|OTHER||||||<|0.001|||||||ANCOVA|||||||< 0.001
72453551|NCT05485805|144429543|OTHER||||||<|0.001|||||||ANCOVA|||||||< 0.001
72453552|NCT05485805|144429543|OTHER||||||<|0.001|||||||ANCOVA|||||||< 0.001
72453553|NCT05485805|144429543|OTHER||||||<|0.001|||||||ANCOVA|||||||< 0.001
72453554|NCT05485805|144429544|OTHER||||||=|0.162|||||||ANCOVA|||||||= 0.162
72453555|NCT05485805|144429544|OTHER||||||=|0.319|||||||ANCOVA|||||||= 0.319
72453556|NCT05485805|144429544|OTHER||||||<|0.001|||||||ANCOVA|||||||< 0.001
72453557|NCT05485805|144429544|OTHER||||||=|0.343|||||||ANCOVA|||||||= 0.343
72453558|NCT05485805|144429544|OTHER||||||=|0.772|||||||ANCOVA|||||||= 0.772
72562312|NCT00112294|144655993|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.89||||0.1685|TWO_SIDED|95.0|0.754|1.051||An interim analysis on survival was performed. Final p-value was adjusted using an alpha spending function. At the interim analysis (data not reported here) the type 1 error was 0.0001, and the rest is for the final look.|Log Rank||The hazard ratio of C/T/C to T/C was estimated by means of a stratified Cox's proportional hazard model with treatment as the single covariate.|Confidence intervals were calculated using Brookmeyer and Crowley method. Analysis was a comparison of survival between groups by means of a 2-sided, alpha=0.05 level, log-rank test, stratified by ECOG PS (0/1) and intended on-study taxane (docetaxel or paclitaxel). Null hypothesis was that survival was equal in both treatment arms. Power calculations indicated that \>= 558 events would lead to at \>=75% power at the 5% level for rejecting the null hypothesis, given a true hazard ratio of 0.8.||1.051|0.754|0.1685
72562313|NCT00112294|144655994|SUPERIORITY_OR_OTHER|||||||0.26||95.0|||||Cochran-Mantel-Haenszel|||Improvement of symptoms was compared between groups by means of a CMH (alpha = 0.05 level) test stratified by ECOG PS (0 or 1) and intended on-study taxane (paclitaxel, docetaxel), as recorded at the time of randomization.||||0.26
72562314|NCT01142908|144656007|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.1||||0.93|TWO_SIDED|95.0|-2.8|3.1|||Mixed Models Analysis|Adjusted for gender, diabetes, and smoking status stratification variables|Direction of the test of comparison is Pharmacist Intervention minus Control|Comparison at 6 months||3.1|-2.8|0.93
72562315|NCT01142908|144656008|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|1.4||||0.34|TWO_SIDED|95.0|-1.5|4.3|||Mixed Models Analysis|Adjusted for gender, diabetes, and smoking status stratification variables|Direction of the test of comparison is Pharmacist Intervention minus Control|Comparison at 12 months.||4.3|-1.5|0.34
72453559|NCT05485805|144429544|OTHER||||||<|0.001|||||||ANCOVA|||||||< 0.001
72562316|NCT01142908|144656010|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.1||||0.91|TWO_SIDED|95.0|-2.0|1.8|||Mixed Models Analysis|Adjusted for gender, diabetes, and smoking status stratification variables|Direction of the test of comparison is Pharmacist Intervention minus Control|Comparison at 6 months||1.8|-2.0|0.91
72562317|NCT01142908|144656011|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.4||||0.7|TWO_SIDED|95.0|-1.5|2.2|||Mixed Models Analysis|Adjusted for gender, diabetes, and smoking status stratification variables|Direction of the test of comparison is Pharmacist Intervention minus Control|Comparison at 12 months.||2.2|-1.5|0.70
72562318|NCT01142908|144656012|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-1.8||||0.1|TWO_SIDED|95.0|-3.9|0.3|||Mixed Models Analysis||Direction of the test of comparison is Pharmacist Intervention minus Control|Comparison at 6 months||0.3|-3.9|0.1
72562319|NCT01142908|144656013|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.3||||0.74|TWO_SIDED|95.0|-2.4|1.7|||Mixed Models Analysis||Direction of the test of comparison is Pharmacist Intervention minus Control|Comparison at 12 months||1.7|-2.4|0.74
72562320|NCT01142908|144656015|SUPERIORITY_OR_OTHER_LEGACY||logit-difference (Net)|-0.03||||0.87|TWO_SIDED|95.0|-0.4|0.3|||Gen. Est. Equation with a Logit Link|Method Used Expanded: Generalized Estimating Equation with a Logit Link. Adjusted for gender, diabetes, and smoking status stratification variables|Direction of the test of comparison is Pharmacist Intervention minus Control|Comparison at 6 months||0.3|-0.4|0.87
72562321|NCT01142908|144656016|SUPERIORITY_OR_OTHER_LEGACY||logit-difference (Net)|0.2||||0.36|TWO_SIDED|95.0|-0.2|0.5|||Gen. Est. Equation with a Logit Link|Method Used Expanded: Generalized Estimating Equation with a Logit Link. Adjusted for gender, diabetes, and smoking status stratification variables|Direction of the test of comparison is Pharmacist Intervention minus Control|Comparison at 12 months.||0.5|-0.2|0.36
72453560|NCT05485805|144429544|OTHER||||||<|0.001|||||||ANCOVA|||||||< 0.001
72453561|NCT05485805|144429544|OTHER||||||<|0.001|||||||ANCOVA|||||||< 0.001
72453562|NCT05485805|144429544|OTHER||||||<|0.001|||||||ANCOVA|||||||< 0.001
72453563|NCT05485805|144429544|OTHER||||||<|0.001|||||||ANCOVA|||||||< 0.001
72453564|NCT05485805|144429547|OTHER||geometric LS mean square|-0.14|||=|0.334|TWO_SIDED|95.0|-0.44|0.15|||ANCOVA|||||0.15|-0.44|= 0.334
72453565|NCT05485805|144429547|OTHER||geometric LS mean square|0.04|||=|0.783|TWO_SIDED|95.0|-0.25|0.33|||ANCOVA|||||0.33|-0.25|= 0.783
72453566|NCT05485805|144429547|OTHER||geometric LS mean square|-0.08|||=|0.687|TWO_SIDED|95.0|-0.5|0.33|||ANCOVA|||||0.33|-0.5|= 0.687
72453567|NCT05485805|144429547|OTHER||geometric LS mean square|-0.02|||=|0.927|TWO_SIDED|95.0|-0.53|0.49|||ANCOVA|||||0.49|-0.53|= 0.927
72453568|NCT05485805|144429547|OTHER||geometric LS mean square|-0.1|||=|0.492|TWO_SIDED|95.0|-0.4|0.19|||ANCOVA|||||0.19|-0.4|= 0.492
72453569|NCT05485805|144429547|OTHER||geometric LS mean square|-0.04|||=|0.836|TWO_SIDED|95.0|-0.46|0.37|||ANCOVA|||||0.37|-0.46|= 0.836
72453570|NCT05485805|144429547|OTHER||geometric LS mean square|-0.11|||=|0.611|TWO_SIDED|95.0|-0.53|0.31|||ANCOVA|||||0.31|-0.53|= 0.611
72453571|NCT05485805|144429547|OTHER||geometric LS mean square|-0.19|||=|0.371|TWO_SIDED|95.0|-0.6|0.22|||ANCOVA|||||0.22|-0.6|= 0.371
72453572|NCT05485805|144429547|OTHER||geometric LS mean square|-0.07|||=|0.752|TWO_SIDED|95.0|-0.49|0.35|||ANCOVA|||||0.35|-0.49|= 0.752
72453573|NCT05485805|144429547|OTHER||geometric LS mean square|-0.21|||=|0.321|TWO_SIDED|95.0|-0.63|0.21|||ANCOVA|||||0.21|-0.63|= 0.321
72453574|NCT04218357|144429555|SUPERIORITY|||||||0.05|TWO_SIDED|95.0|||||GEE|Generalized Estimating Equation with standard errors, and an unstructured correlation matrix with medication and time as within-subject factors.||All outcomes were assessed in real-time in the laboratory testing probenecid compared to placebo condition during the alcohol administration procedure.||||0.05
72562322|NCT01142908|144656018|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-4.9||||0.08|TWO_SIDED|95.0|-10.3|0.6|||Mixed Models Analysis|Adjusted for gender, diabetes, and smoking status stratification variables|Direction of the test of comparison is Pharmacist Intervention minus Control|Comparison at 6 months||0.6|-10.3|0.08
72562323|NCT01142908|144656019|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.8||||0.79|TWO_SIDED|95.0|-6.6|5.0|||Mixed Models Analysis|Adjusted for gender, diabetes, and smoking status stratification variables|Direction of the test of comparison is Pharmacist Intervention minus Control|Comparison at 12 months.||5.0|-6.6|0.79
72562324|NCT01142908|144656021|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.02||||0.83|TWO_SIDED|95.0|-0.2|0.2|||Mixed Models Analysis|Adjusted for gender, diabetes, and smoking status stratification variables|Direction of the test of comparison is Pharmacist Intervention minus Control|Comparison at 6 months||0.2|-0.2|0.83
72562325|NCT01142908|144656022|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.1||||0.54|TWO_SIDED|95.0|-0.4|0.2|||Mixed Models Analysis|Adjusted for gender, diabetes, and smoking status stratification variables|Direction of the test of comparison is Pharmacist Intervention minus Control|Comparison at 12 months.||0.2|-0.4|0.54
72453575|NCT01958021|144429603|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.556||||3.29e-06|TWO_SIDED|95.0|0.429|0.72|||Log Rank|||||0.720|0.429|0.00000329
72453576|NCT01958021|144429604|SUPERIORITY||Hazard Ratio (HR)|0.765||||0.004|TWO_SIDED|95.0|0.628|0.932|||Log Rank|||||0.932|0.628|0.004
72453577|NCT01958021|144429605|SUPERIORITY_OR_OTHER_LEGACY|||||||0.000155|||||||Cochran-Mantel-Haenszel|||||||0.000155
72453578|NCT01958021|144429606|SUPERIORITY_OR_OTHER_LEGACY|||||||0.018|||||||Cochran-Mantel-Haenszel|||||||0.018
72453579|NCT04640974|144429611|OTHER||||||<|0.0001||||||P-Value was calculated|ANOVA|||||||<0.0001
72453580|NCT04640974|144429612|OTHER||||||<|0.0001||||||P-Value was calculated|ANOVA|||||||<0.0001
72453581|NCT04640974|144429613|OTHER||||||<|0.0001||||||P-Value was calculated|ANOVA|||||||<0.0001
72453582|NCT05886777|144429636|NON_INFERIORITY|Null hypothesis(H0) to assess noninferiority with respect to RSVpreF was evaluated by following hypothesis for both RSV A and B as measured by NT: H0: ln(μ1)- ln(μ4) \<= ln(0.5) where ln(0.5) corresponds to a 2-fold margin for noninferiority, ln(μ1), ln(μ4) are natural log of geometric mean of NT 1 month after vaccination for Group 1, 4, respectively.|Geometric mean ratio|0.99|||||TWO_SIDED|97.5|0.782|1.249|||||GMRs and 2-sided confidence intervals (CIs) were calculated by exponentiating mean differences of logarithms of titers (Intervention Group \[Group 1\] minus Reference Group \[Group 4\]) and corresponding CIs (based on the Student t distribution).|||1.249|0.782|
72453583|NCT05886777|144429637|NON_INFERIORITY|Null hypothesis(H0) to assess noninferiority with respect to RSVpreF was evaluated by following hypothesis for both RSV A and B as measured by NT: H0: ln(μ1)- ln(μ4) \<= ln(0.5) where ln(0.5) corresponds to a 2-fold margin for noninferiority, ln(μ1), ln(μ4) are natural log of geometric mean of NT 1 month after vaccination for Group 1, 4, respectively.|Geometric mean ratio|0.9|||||TWO_SIDED|97.5|0.697|1.162|||||GMRs and 2-sided CIs were calculated by exponentiating mean differences of the logarithms of titers (Intervention Group \[Group 1\] minus Reference Group \[Group 4\]) and corresponding CIs (based on the Student t distribution).|||1.162|0.697|
72453584|NCT05886777|144429638|NON_INFERIORITY|Null hypothesis (H0) to assess noninferiority with respect to BNT162b2 was evaluated by following hypothesis for both SARS-CoV-2 Omicron BA.4/BA.5 strain and reference strain as measured by NT: H0: ln(μ1)- ln(μ3) \<= ln(0.5) where ln(0.5) corresponds to a 2-fold margin for noninferiority, and ln(μ1) and ln(μ3) are natural log of geometric mean of NT 1 month after vaccination for Group 1, 3, respectively.|Geometric mean ratio|0.84|||||TWO_SIDED|97.5|0.605|1.168|||||GMRs and 2-sided CIs were calculated by exponentiating mean differences of the logarithms of titers (Intervention Group \[Group 1\] minus Reference Group \[Group 3\]) and corresponding CIs (based on the Student t distribution).|||1.168|0.605|
72453585|NCT05886777|144429639|NON_INFERIORITY|Null hypothesis (H0) to assess noninferiority with respect to BNT162b2 was evaluated by following hypothesis for both SARS-CoV-2 Omicron BA.4/BA.5 strain and reference strain as measured by NT: H0: ln(μ1)- ln(μ3) \<= ln(0.5) where ln(0.5) corresponds to a 2-fold margin for noninferiority, and ln(μ1) and ln(μ3) are natural log of geometric mean of NT 1 month after vaccination for Group 1, 3, respectively.|Geometric mean ratio|0.79|||||TWO_SIDED|97.5|0.618|1.014|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences of the logarithms of the titers (Intervention Group \[Group 1\] minus Reference Group \[Group 3\]) and the corresponding CIs (based on the Student t distribution).|||1.014|0.618|
72453586|NCT05886777|144429640|NON_INFERIORITY|Null hypothesis (H0) to assess noninferiority with respect to QIV was evaluated by following hypothesis for each of 4 strains included in QIV as measured by HAI titer: H0: ln(μ1)- ln(μ5) \<= ln(0.5) where ln(0.5) corresponds to a 2-fold margin for noninferiority, and ln(μ1) and ln(μ5) are natural log of the geometric mean of HAI titers 1 month after vaccination for Group 1,5, respectively.|Geometric mean ratio|1.06|||||TWO_SIDED|97.5|0.785|1.423|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences of the logarithms of the titers (Intervention Group \[Group 1\] minus Reference Group \[Group 5\]) and the corresponding CIs (based on the Student t distribution).|||1.423|0.785|
72453587|NCT05886777|144429641|NON_INFERIORITY|Null hypothesis (H0) to assess noninferiority with respect to QIV was evaluated by following hypothesis for each of 4 strains included in QIV as measured by HAI titer: H0: ln(μ1)- ln(μ5) \<= ln(0.5) where ln(0.5) corresponds to a 2-fold margin for noninferiority, and ln(μ1) and ln(μ5) are natural log of the geometric mean of HAI titers 1 month after vaccination for Group 1,5, respectively.|Geometric mean ratio|1.13|||||TWO_SIDED|97.5|0.909|1.402|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences of the logarithms of the titers (Intervention Group \[Group 1\] minus Reference Group \[Group 5\]) and the corresponding CIs (based on the Student t distribution).|||1.402|0.909|
72453588|NCT05886777|144429642|NON_INFERIORITY|Null hypothesis (H0) to assess noninferiority with respect to QIV was evaluated by following hypothesis for each of 4 strains included in QIV as measured by HAI titer: H0: ln(μ1)- ln(μ5) \<= ln(0.5) where ln(0.5) corresponds to a 2-fold margin for noninferiority, and ln(μ1) and ln(μ5) are natural log of the geometric mean of HAI titers 1 month after vaccination for Group 1,5, respectively.|Geometric mean ratio|1.05|||||TWO_SIDED|97.5|0.773|1.434|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences of the logarithms of the titers (Intervention Group \[Group 1\] minus Reference Group \[Group 5\]) and the corresponding CIs (based on the Student t distribution).|||1.434|0.773|
72453589|NCT05886777|144429643|NON_INFERIORITY|Null hypothesis (H0) to assess noninferiority with respect to QIV was evaluated by following hypothesis for each of 4 strains included in QIV as measured by HAI titer: H0: ln(μ1)- ln(μ5) \<= ln(0.5) where ln(0.5) corresponds to a 2-fold margin for noninferiority, and ln(μ1) and ln(μ5) are natural log of the geometric mean of HAI titers 1 month after vaccination for Group 1,5, respectively.|Geometric mean ratio|1.11|||||TWO_SIDED|97.5|0.807|1.515|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences of the logarithms of the titers (Intervention Group \[Group 1\] minus Reference Group \[Group 5\]) and the corresponding CIs (based on the Student t distribution).|||1.515|0.807|
72562326|NCT01142908|144656024|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.2||||0.29|TWO_SIDED|95.0|-0.6|0.2|||Mixed Models Analysis|Adjusted for gender and smoking status stratification variables|Direction of the test of comparison is Pharmacist Intervention minus Control|Comparison at 6 months||0.2|-0.6|0.29
72453590|NCT05886777|144429644|NON_INFERIORITY|Null hypothesis(H0) to assess noninferiority with respect to RSVpreF was evaluated by following hypothesis for both RSV A, RSV B as measured by NT:H0: ln(μ2)- ln(μ4) \<=ln(0.5) where ln(0.5) corresponds to a 2-fold margin for noninferiority and ln(μ2) and ln(μ4) are natural log of geometric mean of NT 1 month after vaccination for Group 2, 4, respectively.|Geometric mean ratio|1.0|||||TWO_SIDED|97.5|0.769|1.288|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences of the logarithms of the titers (Intervention Group \[Group 2\] minus Reference Group \[Group 4\]) and the corresponding CIs (based on the Student t distribution).|||1.288|0.769|
72453591|NCT05886777|144429645|NON_INFERIORITY|Null hypothesis(H0) to assess noninferiority with respect to RSVpreF was evaluated by following hypothesis for both RSV A, RSV B as measured by NT:H0: ln(μ2)- ln(μ4) \<=ln(0.5) where ln(0.5) corresponds to a 2-fold margin for noninferiority and ln(μ2) and ln(μ4) are natural log of geometric mean of NT 1 month after vaccination for Group 2, 4, respectively.|Geometric mean ratio|1.09|||||TWO_SIDED|97.5|0.836|1.429|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences of the logarithms of the titers (Intervention Group \[Group 2\] minus Reference Group \[Group 4\]) and the corresponding CIs (based on the Student t distribution).|||1.429|0.836|
72453592|NCT05886777|144429646|NON_INFERIORITY|Null hypothesis (H0) to assess noninferiority with respect to BNT162b2 will be evaluated by following hypothesis for both SARS-CoV-2 Omicron BA.4/BA.5 strain and reference strain as measured by NT:H0: ln(μ2)- ln(μ3) \<= ln(0.5)where ln(0.5) corresponds to a 2-fold margin for noninferiority and ln(μ2) and ln(μ3) are natural log of geometric mean of NT 1 month after vaccination for Group 2,3, respectively.|Geometric mean ratio|0.84|||||TWO_SIDED|97.5|0.594|1.19|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences of the logarithms of the titers (Intervention Group \[Group 2\] minus Reference Group \[Group 3\]) and the corresponding CIs (based on the Student t distribution).|||1.190|0.594|
72453593|NCT05886777|144429647|NON_INFERIORITY|Null hypothesis (H0) to assess noninferiority with respect to BNT162b2 will be evaluated by following hypothesis for both SARS-CoV-2 Omicron BA.4/BA.5 strain and reference strain as measured by NT:H0: ln(μ2)- ln(μ3) \<= ln(0.5)where ln(0.5) corresponds to a 2-fold margin for noninferiority and ln(μ2) and ln(μ3) are natural log of geometric mean of NT 1 month after vaccination for Group 2,3, respectively.|Geometric mean ratio|0.84|||||TWO_SIDED|97.5|0.632|1.125|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences of the logarithms of the titers (Intervention Group \[Group 2\] minus Reference Group \[Group 3\]) and the corresponding CIs (based on the Student t distribution).|||1.125|0.632|
72453594|NCT05886777|144429648|NON_INFERIORITY|Null hypothesis(H0) to assess noninferiority with respect to RSVpreF was evaluated by following hypothesis for both RSV A and B as measured by NT: H0: ln(μ1)- ln(μ4) \<= ln(0.5) where ln(0.5) corresponds to a 2-fold margin for noninferiority, ln(μ1), ln(μ4) are natural log of geometric mean of NT 1 month after vaccination for Group 7, 4, respectively.|Geometric mean ratio|1.42|||||TWO_SIDED|97.5|1.123|1.801|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences of the logarithms of the titers (Intervention Group \[Group 7\] minus Reference Group \[Group 4\]) and the corresponding CIs (based on the Student t distribution).|||1.801|1.123|
72453595|NCT05886777|144429649|NON_INFERIORITY|Null hypothesis(H0) to assess noninferiority with respect to RSVpreF was evaluated by following hypothesis for both RSV A and B as measured by NT: H0: ln(μ1)- ln(μ4) \<= ln(0.5) where ln(0.5) corresponds to a 2-fold margin for noninferiority, ln(μ1), ln(μ4) are natural log of geometric mean of NT 1 month after vaccination for Group 7, 4, respectively.|Geometric mean ratio|1.27|||||TWO_SIDED|97.5|0.977|1.651|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences of the logarithms of the titers (Intervention Group \[Group 7\] minus Reference Group \[Group 4\]) and the corresponding CIs (based on the Student t distribution).|||1.651|0.977|
72453596|NCT05886777|144429650|NON_INFERIORITY|Null hypothesis (H0) to assess noninferiority with respect to BNT162b2 will be evaluated by following hypothesis for both SARS-CoV-2 Omicron BA.4/BA.5 strain and reference strain as measured by NT:H0: ln(μ2)- ln(μ3) \<= ln(0.5)where ln(0.5) corresponds to a 2-fold margin for noninferiority and ln(μ2) and ln(μ3) are natural log of geometric mean of NT 1 month after vaccination for Group 7,3, respectively.|Geometric mean ratio|0.86|||||TWO_SIDED|97.5|0.61|1.208|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences of the logarithms of the titers (Intervention Group \[Group 7\] minus Reference Group \[Group 3\]) and the corresponding CIs (based on the Student t distribution).|||1.208|0.610|
72453597|NCT05886777|144429651|NON_INFERIORITY|Null hypothesis (H0) to assess noninferiority with respect to BNT162b2 was evaluated by following hypothesis for both SARS-CoV-2 Omicron BA.4/BA.5 strain and reference strain as measured by NT: H0: ln(μ1)- ln(μ3) \<= ln(0.5) where ln(0.5) corresponds to a 2-fold margin for noninferiority, and ln(μ1) and ln(μ3) are natural log of geometric mean of NT 1 month after vaccination for Group 7, 3, respectively.|Geometric mean ratio|1.01|||||TWO_SIDED|97.5|0.764|1.34|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences of the logarithms of the titers (Intervention Group \[Group 7\] minus Reference Group \[Group 3\]) and the corresponding CIs (based on the Student t distribution).|||1.340|0.764|
72453598|NCT05886777|144429652|NON_INFERIORITY|Null hypothesis (H0) to assess noninferiority with respect to QIV was evaluated by following hypothesis for each of 4 strains included in QIV as measured by HAI titer: H0: ln(μ1)- ln(μ5) \<= ln(0.5) where ln(0.5) corresponds to a 2-fold margin for noninferiority, and ln(μ1) and ln(μ5) are natural log of the geometric mean of HAI titers 1 month after vaccination for Group 7,5, respectively.|Geometric mean ratio|2.49|||||TWO_SIDED|97.5|1.914|3.232|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences of the logarithms of the titers (Intervention Group \[Group 7\] minus Reference Group \[Group 5\]) and the corresponding CIs (based on the Student t distribution).|||3.232|1.914|
72453599|NCT05886777|144429653|NON_INFERIORITY|Null hypothesis (H0) to assess noninferiority with respect to QIV was evaluated by following hypothesis for each of 4 strains included in QIV as measured by HAI titer: H0: ln(μ1)- ln(μ5) \<= ln(0.5) where ln(0.5) corresponds to a 2-fold margin for noninferiority, and ln(μ1) and ln(μ5) are natural log of the geometric mean of HAI titers 1 month after vaccination for Group 7,5, respectively.|Geometric mean ratio|1.3|||||TWO_SIDED|97.5|1.049|1.612|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences of the logarithms of the titers (Intervention Group \[Group 7\] minus Reference Group \[Group 5\]) and the corresponding CIs (based on the Student t distribution).|||1.612|1.049|
72562327|NCT01142908|144656025|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.1||||0.72|TWO_SIDED|95.0|-0.5|0.4|||Mixed Models Analysis|Adjusted for gender and smoking status stratification variables|Direction of the test of comparison is Pharmacist Intervention minus Control|Comparison at 12 months||0.4|-0.5|0.72
72620171|NCT00276380|144771271|OTHER|Comparison of treatment effect at Day 28|Odds Ratio (OR)|0.86||||0.623|TWO_SIDED|95.0|0.47|1.57|||Cochran-Mantel-Haenszel||The homogeneity of the Odds Ratio (OR) across centres was assessed by the Breslow Day test.|The association between treatment and response after adjustment for the pooled centres was analysed using a Cochran-Mantel-Haenszel test.||1.57|0.47|0.623
72620172|NCT00276380|144771271|OTHER|Comparison of treatment effect at Day 84|Odds Ratio (OR)|0.74||||0.3|TWO_SIDED|95.0|0.42|1.3|||Cochran-Mantel-Haenszel||The homogeneity of the Odds Ratio (OR) across centres was assessed by the Breslow Day test.|The association between treatment and response after adjustment for the pooled centres was analysed using a Cochran-Mantel-Haenszel test.||1.3|0.42|0.3
72620173|NCT00276380|144771273|OTHER|||||||0.207||||||Treatment effect was derived using a parametric analysis of covariance (ANCOVA) with baseline and pooled centres as covariates.|ANCOVA|||Comparison of treatment effect at Day 28||||0.207
72453600|NCT05886777|144429654|NON_INFERIORITY|Null hypothesis (H0) to assess noninferiority with respect to QIV was evaluated by following hypothesis for each of 4 strains included in QIV as measured by HAI titer: H0: ln(μ1)- ln(μ5) \<= ln(0.5) where ln(0.5) corresponds to a 2-fold margin for noninferiority, and ln(μ1) and ln(μ5) are natural log of the geometric mean of HAI titers 1 month after vaccination for Group 7,5, respectively.|Geometric mean ratio|1.58|||||TWO_SIDED|97.5|1.155|2.165|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences of the logarithms of the titers (Intervention Group \[Group 7\] minus Reference Group \[Group 5\]) and the corresponding CIs (based on the Student t distribution).|||2.165|1.155|
72499531|NCT01431287|144529523|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.048|STANDARD_ERROR_OF_MEAN|0.013||0.0002|TWO_SIDED|95.0|0.023|0.073||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.073|0.023|0.0002
72499532|NCT01431287|144529523|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.041|STANDARD_ERROR_OF_MEAN|0.013||0.0014|TWO_SIDED|95.0|0.016|0.067||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.067|0.016|0.0014
72499533|NCT01431287|144529523|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.018|STANDARD_ERROR_OF_MEAN|0.013||0.1747|TWO_SIDED|95.0|-0.008|0.043||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.043|-0.008|0.1747
72499534|NCT01431287|144529523|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.065|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|0.04|0.091||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.091|0.040|<0.0001
72499535|NCT01431287|144529523|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.041|STANDARD_ERROR_OF_MEAN|0.013||0.0016|TWO_SIDED|95.0|0.016|0.066||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.066|0.016|0.0016
72620174|NCT00276380|144771273|OTHER|||||||0.59||||||Treatment effect was derived using an ANCOVA analysis with baseline and pooled centres as covariates.|ANCOVA|||Comparison of treatment effect at Day 84||||0.590
72499536|NCT01431287|144529523|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.034|STANDARD_ERROR_OF_MEAN|0.013||0.0081|TWO_SIDED|95.0|0.009|0.06||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.060|0.009|0.0081
72499537|NCT01431287|144529523|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.007|STANDARD_ERROR_OF_MEAN|0.013||0.611|TWO_SIDED|95.0|-0.019|0.032||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.032|-0.019|0.6110
72620175|NCT00276380|144771273|OTHER|Treatment effect was derived using an ANCOVA analysis with baseline and pooled centres as covariates.||||||0.814|||||||ANCOVA|||Comparison of treatment effect at Day 168||||0.814
72620176|NCT00276380|144771274|OTHER|||||||0.24||||||Treatment effect was derived using an ANCOVA analysis with baseline and pooled centres as covariates.|ANCOVA|||Comparison of treatment effect at Day 28||||0.240
72620177|NCT00276380|144771274|OTHER|||||||0.441||||||Treatment effect was derived using an ANCOVA analysis with baseline and pooled centres as covariates.|ANCOVA|||Comparison of treatment effect at Day 84||||0.441
72620178|NCT00276380|144771274|OTHER|||||||0.645||||||Treatment effect was derived using an ANCOVA analysis with baseline and pooled centres as covariates.|ANCOVA|||Comparison of treatment effect at Day 168||||0.645
72620179|NCT00276380|144771275|OTHER|||||||0.623||||||Treatment effect was derived using an ANCOVA analysis with baseline and pooled centres as covariates.|ANCOVA|||Comparison of treatment effect at Day 28||||0.623
72620180|NCT00276380|144771275|OTHER|||||||0.338||||||Treatment effect was derived using an ANCOVA analysis with baseline and pooled centres as covariates.|ANCOVA|||Comparison of treatment effect at Day 84||||0.338
72620181|NCT00276380|144771275|OTHER|||||||0.828||||||Treatment effect was derived using an ANCOVA analysis with baseline and pooled centres as covariates|ANCOVA|||Comparison of treatment effect at Day 168||||0.828
72453601|NCT05886777|144429655|NON_INFERIORITY|Null hypothesis (H0) to assess noninferiority with respect to QIV was evaluated by following hypothesis for each of 4 strains included in QIV as measured by HAI titer: H0: ln(μ1)- ln(μ5) \<= ln(0.5) where ln(0.5) corresponds to a 2-fold margin for noninferiority, and ln(μ1) and ln(μ5) are natural log of the geometric mean of HAI titers 1 month after vaccination for Group 7,5, respectively.|Geometric mean ratio|3.49|||||TWO_SIDED|97.5|2.64|4.604|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences of the logarithms of the titers (Intervention Group \[Group 7\] minus Reference Group \[Group 5\]) and the corresponding CIs (based on the Student t distribution).|||4.604|2.640|
72453602|NCT05886777|144429656|NON_INFERIORITY|Null hypothesis(H0) to assess noninferiority with respect to RSVpreF was evaluated by following hypothesis for both RSV A and B as measured by NT: H0: ln(μ1)- ln(μ4) \<= ln(0.5) where ln(0.5) corresponds to a 2-fold margin for noninferiority, ln(μ1), ln(μ4) are natural log of geometric mean of NT 1 month after vaccination for Group 6, 4, respectively.|Geometric mean ratio|1.43|||||TWO_SIDED|97.5|1.131|1.808|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences of the logarithms of the titers (Intervention Group \[Group 6\] minus Reference Group \[Group 4\]) and the corresponding CIs (based on the Student t distribution).|||1.808|1.131|
72453603|NCT05886777|144429657|NON_INFERIORITY|Null hypothesis(H0) to assess noninferiority with respect to RSVpreF was evaluated by following hypothesis for both RSV A and B as measured by NT: H0: ln(μ1)- ln(μ4) \<= ln(0.5) where ln(0.5) corresponds to a 2-fold margin for noninferiority, ln(μ1), ln(μ4) are natural log of geometric mean of NT 1 month after vaccination for Group 6, 4, respectively.|Geometric mean ratio|1.37|||||TWO_SIDED|97.5|1.06|1.773|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences of the logarithms of the titers (Intervention Group \[Group 6\] minus Reference Group \[Group 4\]) and the corresponding CIs (based on the Student t distribution).|||1.773|1.060|
72562328|NCT04291508|144656089|SUPERIORITY||Mean Difference (Final Values)|0.5||||0.65|TWO_SIDED|95.0|-1.6|2.5|||t-test, 2 sided|||||2.5|-1.6|0.65
72453604|NCT05886777|144429658|NON_INFERIORITY|Null hypothesis (H0) to assess noninferiority with respect to BNT162b2 will be evaluated by following hypothesis for both SARS-CoV-2 Omicron BA.4/BA.5 strain and reference strain as measured by NT:H0: ln(μ2)- ln(μ3) \<= ln(0.5)where ln(0.5) corresponds to a 2-fold margin for noninferiority and ln(μ2) and ln(μ3) are natural log of geometric mean of NT 1 month after vaccination for Group 6,3, respectively.|Geometric mean ratio|0.94|||||TWO_SIDED|97.5|0.673|1.3|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences of the logarithms of the titers (Intervention Group \[Group 6\] minus Reference Group \[Group 3\]) and the corresponding CIs (based on the Student t distribution).|||1.300|0.673|
72453605|NCT05886777|144429659|NON_INFERIORITY|Null hypothesis (H0) to assess noninferiority with respect to BNT162b2 will be evaluated by following hypothesis for both SARS-CoV-2 Omicron BA.4/BA.5 strain and reference strain as measured by NT:H0: ln(μ2)- ln(μ3) \<= ln(0.5)where ln(0.5) corresponds to a 2-fold margin for noninferiority and ln(μ2) and ln(μ3) are natural log of geometric mean of NT 1 month after vaccination for Group 6,3, respectively.|Geometric mean ratio|0.97|||||TWO_SIDED|97.5|0.74|1.281|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences of the logarithms of the titers (Intervention Group \[Group 6\] minus Reference Group \[Group 3\]) and the corresponding CIs (based on the Student t distribution).|||1.281|0.740|
72453606|NCT04701203|144429671|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||For the primary efficacy endpoint, the Cochran-Mantel Haenszel test stratified by etiology of hypoparathyroidism (postsurgical or other) was used to compare the proportion of participants meeting the composite primary endpoint in the TransCon PTH versus placebo groups. Participants without week 26 albumin-adjusted serum calcium or with \>25% (ie, \>7 days) missing diary data of active vitamin D or elemental calcium during the 4 weeks before week 26 were considered non-responders.||||<0.0001
72453607|NCT04701203|144429672|SUPERIORITY||||||=|0.0038|||||||t-test, 2 sided|||ANCOVA model with unequal variance was used to analyze the key secondary Endpoints. The change from baseline is variable of interest at week 26 and was included in the model as response variables. Treatment assignment and etiology of hypoparathyroidism were entered as fixed effects and baseline value of the variable of interest was entered as a covariate.||||= 0.0038
72453608|NCT04701203|144429673|SUPERIORITY||||||=|0.0055|||||||t-test, 2 sided|||ANCOVA model with unequal variance was used to analyze the key secondary Endpoints. The change from baseline is variable of interest at week 26 and was included in the model as response variables. Treatment assignment and etiology of hypoparathyroidism were entered as fixed effects and baseline value of the variable of interest was entered as a covariate.||||= 0.0055
72453609|NCT04701203|144429674|SUPERIORITY||||||=|0.0046|||||||t-test, 2 sided|||ANCOVA model with unequal variance was used to analyze the key secondary Endpoints. The change from baseline is variable of interest at week 26 and was included in the model as response variables. Treatment assignment and etiology of hypoparathyroidism were entered as fixed effects and baseline value of the variable of interest was entered as a covariate.||||= 0.0046
72453610|NCT04701203|144429675|SUPERIORITY||||||=|0.0061|||||||t-test, 2 sided|||ANCOVA model with unequal variance was used to analyze the key secondary Endpoints. The change from baseline is variable of interest at week 26 and was included in the model as response variables. Treatment assignment and etiology of hypoparathyroidism were entered as fixed effects and baseline value of the variable of interest was entered as a covariate.||||= 0.0061
72453611|NCT04701203|144429676|SUPERIORITY||||||=|0.0347|||||||t-test, 2 sided|||ANCOVA model with unequal variance was used to analyze the key secondary Endpoints. The change from baseline is variable of interest at week 26 and was included in the model as response variables. Treatment assignment and etiology of hypoparathyroidism were entered as fixed effects and baseline value of the variable of interest was entered as a covariate.||||= 0.0347
72562329|NCT04291508|144656089|SUPERIORITY||Mean Difference (Final Values)|2.0||||0.464|TWO_SIDED|95.0|-3.5|7.6|||t-test, 2 sided|||||7.6|-3.5|0.464
72562330|NCT04291508|144656090|SUPERIORITY||Risk Difference (RD)|-4.3||||0.26|TWO_SIDED|95.0|-12.0|3.3|||Chi-squared|||||3.3|-12.0|0.26
72562331|NCT04291508|144656090|SUPERIORITY||Risk Difference (RD)|-13.6||||0.31|TWO_SIDED|95.0|-35.8|8.7|||Fisher Exact|||||8.7|-35.8|0.31
72562332|NCT04291508|144656091|SUPERIORITY||Mean Difference (Final Values)|1.0||||0.35|TWO_SIDED|95.0|-1.0|2.9|||t-test, 2 sided|||||2.9|-1.0|0.35
72562333|NCT04291508|144656091|SUPERIORITY||Mean Difference (Final Values)|2.1||||0.45|TWO_SIDED|95.0|-3.4|7.6|||t-test, 2 sided|||||7.6|-3.4|0.45
72562334|NCT04291508|144656092|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.83|TWO_SIDED|95.0|-1.9|1.5|||t-test, 2 sided|||||1.5|-1.9|0.83
72499538|NCT01431287|144529524|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.085|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|0.059|0.111||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.111|0.059|<0.0001
72562335|NCT04291508|144656092|SUPERIORITY||Mean Difference (Final Values)|4.0||||0.1|TWO_SIDED|95.0|-0.8|8.9|||t-test, 2 sided|||||8.9|-0.8|0.10
72562336|NCT04291508|144656093|SUPERIORITY||Mean Difference (Final Values)|0.6||||0.55|TWO_SIDED|95.0|-1.2|2.4|||t-test, 2 sided|||||2.4|-1.2|0.55
72562337|NCT04291508|144656093|SUPERIORITY||Mean Difference (Final Values)|3.5||||0.18|TWO_SIDED|95.0|-1.6|8.7|||t-test, 2 sided|||||8.7|-1.6|0.18
72562338|NCT04291508|144656094|SUPERIORITY||Mean Difference (Final Values)|1.4||||0.21|TWO_SIDED|95.0|-0.8|3.6|||t-test, 2 sided|||||3.6|-0.8|0.21
72562339|NCT04291508|144656094|SUPERIORITY||Mean Difference (Final Values)|2.5||||0.4|TWO_SIDED|95.0|-3.4|8.5|||t-test, 2 sided|||||8.5|-3.4|0.40
72562340|NCT04291508|144656095|SUPERIORITY||Mean Difference (Final Values)|1.3||||0.23|TWO_SIDED|95.0|-0.8|3.4|||t-test, 2 sided|||||3.4|-0.8|0.23
72562341|NCT04291508|144656095|SUPERIORITY||Mean Difference (Final Values)|3.6||||0.22|TWO_SIDED|95.0|-2.2|9.4|||t-test, 2 sided|||||9.4|-2.2|0.22
72562342|NCT04291508|144656096|SUPERIORITY||Mean Difference (Final Values)|0.6||||0.58|TWO_SIDED|95.0|-1.6|2.8|||t-test, 2 sided|||||2.8|-1.6|0.58
72562343|NCT04291508|144656096|SUPERIORITY||Mean Difference (Final Values)|4.5||||0.13|TWO_SIDED|95.0|-1.4|10.5|||t-test, 2 sided|||||10.5|-1.4|0.13
72562344|NCT04291508|144656097|SUPERIORITY||Risk Difference (RD)|-4.3||||0.26|TWO_SIDED|95.0|-11.8|3.2|||Chi-squared|||||3.2|-11.8|0.26
72562345|NCT04291508|144656097|SUPERIORITY||Risk Difference (RD)|-13.6||||0.31|TWO_SIDED|95.0|-35.8|8.7|||Fisher Exact|||||8.7|-35.8|0.31
72620182|NCT04829214|144771279|SUPERIORITY||Risk Difference (RD)|-10.2|STANDARD_ERROR_OF_MEAN|7.9|=|0.385|TWO_SIDED|95.0|-26.0|5.0|||Mantel Haenszel|||The percentage of responders will be compared between the two groups using the Mantel Haenszel test controlling for category of duration of tinnitus and category of baseline TFI overall score. The primary efficacy analysis will be conducted for the comparison of OTO-313 and placebo, using a 2-sided test and an alpha level of 5%. The 95% confidence intervals (CI) around the common risk difference will also be provided.||5|-26|=0.385
72499539|NCT01431287|144529524|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.05|STANDARD_ERROR_OF_MEAN|0.013||0.0001|TWO_SIDED|95.0|0.025|0.076||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.076|0.025|0.0001
72562346|NCT04291508|144656098|SUPERIORITY||Mean Difference (Final Values)|0.3||||0.76|TWO_SIDED|95.0|-1.6|2.2|||t-test, 2 sided|||||2.2|-1.6|0.76
72562347|NCT04291508|144656098|SUPERIORITY||Mean Difference (Final Values)|0.8||||0.78|TWO_SIDED|95.0|-4.9|6.5|||t-test, 2 sided|||||6.5|-4.9|0.78
72562348|NCT04291508|144656099|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.84|TWO_SIDED|95.0|-2.3|1.9|||t-test, 2 sided|||||1.9|-2.3|0.84
72562349|NCT04291508|144656099|SUPERIORITY||Mean Difference (Final Values)|4.5||||0.1|TWO_SIDED|95.0|-0.9|10.0|||t-test, 2 sided|||||10.0|-0.9|0.10
72562350|NCT04291508|144656100|SUPERIORITY||Risk Difference (RD)|-1.3||||0.79|TWO_SIDED|95.0|-10.9|8.3|||Chi-squared|||||8.3|-10.9|0.79
72562351|NCT04291508|144656100|SUPERIORITY||Risk Difference (RD)|4.9||||1|TWO_SIDED|95.0|-17.5|27.3|||Fisher Exact|||||27.3|-17.5|1.00
72562352|NCT04291508|144656101|SUPERIORITY||Risk Difference (RD)|1.7||||0.53|TWO_SIDED|95.0|-3.7|7.2|||Chi-squared|||||7.2|-3.7|0.53
72562353|NCT04291508|144656101|SUPERIORITY||Risk Difference (RD)|-2.0||||1|TWO_SIDED|95.0|-17.0|13.0|||Fisher Exact|||||13.0|-17.0|1.00
72562354|NCT04291508|144656102|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.7|TWO_SIDED|95.0|-0.9|0.6|||t-test, 2 sided|||||0.6|-0.9|0.70
72562355|NCT04291508|144656102|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.96|TWO_SIDED|95.0|-2.7|2.5|||t-test, 2 sided|||||2.5|-2.7|0.96
72562356|NCT04291508|144656103|SUPERIORITY||Risk Difference (RD)|2.5||||1|TWO_SIDED|95.0|-2.3|7.3|||Fisher Exact|||||7.3|-2.3|1.00
72562357|NCT04291508|144656104|SUPERIORITY||Risk Difference (RD)|-4.4||||0.31|TWO_SIDED|95.0|-13.1|4.2|||Chi-squared|||||4.2|-13.1|0.31
72562358|NCT04291508|144656104|SUPERIORITY||Risk Difference (RD)|-27.9||||0.02|TWO_SIDED|95.0|-51.7|-4.0|||Chi-squared|||||-4.0|-51.7|0.02
72562359|NCT04291508|144656105|SUPERIORITY||Risk Difference (RD)|-0.5||||0.9|TWO_SIDED|95.0|-8.5|7.5|||Chi-squared|||||7.5|-8.5|0.90
72562360|NCT04291508|144656105|SUPERIORITY||Risk Difference (RD)|-27.9||||0.02|TWO_SIDED|95.0|-51.7|-4.0|||Chi-squared|||||-4.0|-51.7|0.02
72562361|NCT04291508|144656106|SUPERIORITY||Risk Difference (RD)|-7.3||||0.003|TWO_SIDED|95.0|-12.2|-2.4|||Chi-squared|||||-2.4|-12.2|0.003
72562362|NCT04291508|144656106|SUPERIORITY||Risk Difference (RD)|6.7||||0.52|TWO_SIDED|95.0|-2.3|15.6|||Fisher Exact|||||15.6|-2.3|0.52
72562363|NCT04291508|144656107|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.68|TWO_SIDED|95.0|-0.2|0.2|||t-test, 2 sided|||||0.2|-0.2|0.68
72562364|NCT04291508|144656107|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.62|TWO_SIDED|95.0|-0.7|0.4|||Fisher Exact|||||0.4|-0.7|0.62
72562365|NCT04291508|144656108|SUPERIORITY||Risk Difference (RD)|0.5||||0.9|TWO_SIDED|95.0|-7.8|8.8|||Chi-squared|||||8.8|-7.8|0.90
72562366|NCT04291508|144656108|SUPERIORITY||Risk Difference (RD)|-15.6||||0.2|TWO_SIDED|95.0|-40.1|8.9|||Chi-squared|||||8.9|-40.1|0.2
72562367|NCT04291508|144656109|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.88|TWO_SIDED|95.0|-1.1|1.3|||t-test, 2 sided|||||1.3|-1.1|0.88
72562368|NCT04291508|144656109|SUPERIORITY||Mean Difference (Final Values)|3.0||||0.1|TWO_SIDED|95.0|-0.6|6.6|||t-test, 2 sided|||||6.6|-0.6|0.10
72620183|NCT02571244|144771298|SUPERIORITY||Risk Ratio (RR)|1.35|||||TWO_SIDED|95.0|0.99|1.85||||||||1.85|0.99|
72620184|NCT02571244|144771299|SUPERIORITY|||||||0.28|||||||t-test, 2 sided|||||||0.28
72620185|NCT02571244|144771300|SUPERIORITY|||||||0.42|||||||Fisher Exact|||||||0.42
72620186|NCT02571244|144771301|SUPERIORITY||Risk Ratio (RR)|1.45|||||TWO_SIDED|95.0|1.08|1.95||||||||1.95|1.08|
72562369|NCT03566238|144656110|SUPERIORITY|"ANCOVA model including treatment, baseline pruritus score at AM and PM, PFIC type, and age category was used for treatment comparisons. A pooled analysis for the closed testing procedure was applied to control multiplicity. The one-sided adjusted p-value for an individual dose was calculated as the maximum value of the unadjusted p-value for the pooled analysis and the unadjusted p-value for the individual doses.~One-sided adjusted p-value was reported."|LS mean difference|28.23|STANDARD_ERROR_OF_MEAN|9.182||0.0019|TWO_SIDED|95.0|9.83|46.64|||ANCOVA|||Analysis of the Proportion of Positive Pruritus Assessments at Participant Level over the 24-Week Treatment Period - Albireo ObsRO Instrument (AM and PM Scores)||46.64|9.83|0.0019
72620187|NCT02571244|144771302|SUPERIORITY||Risk Ratio (RR)|1.44|||||TWO_SIDED|95.0|1.07|1.92||||||||1.92|1.07|
72453612|NCT02232737|144429677|SUPERIORITY||Mean Difference (Net)|-5.33|STANDARD_ERROR_OF_MEAN|1.06|<|0.0001|TWO_SIDED|95.0|-7.41|-3.26||The p-value is Bonferroni-corrected for multiple comparisons with a priori threshold of significance P \< 0.0167|ANCOVA||Group difference = 0.12 mg nicotine - 0.8 mg nicotine|The statistical analysis method was ANCOVA, in order to test for statistically significant differences between group means, while controlling for covariates of interest. It was calculated that 207 subjects per group would be required to have at least 90% power to detect a mean difference of 4.52 CPD between the 0.8 mg and 0.12 mg groups at week 12, with significance level alpha of 0.0167. The significance level reflects the Bonferroni correction needed for testing of all pairwise comparisons.||-3.26|-7.41|<0.0001
72453613|NCT02232737|144429677|SUPERIORITY||Mean Difference (Net)|-7.54|STANDARD_ERROR_OF_MEAN|1.0|<|0.0001|TWO_SIDED|95.0|-9.51|-5.57||The p-value is Bonferroni-corrected for multiple comparisons with a priori threshold of significance P \< 0.0167|ANCOVA||Group difference = 0.03 mg nicotine - 0.8 mg nicotine|The statistical analysis method was ANCOVA, in order to test for statistically significant differences between group means, while controlling for covariates of interest. It was calculated that 207 subjects per group would be required to have at least 90% power to detect a mean difference of 4.52 CPD between the 0.8 mg and 0.12 mg groups at week 12, with significance level alpha of 0.0167. The significance level reflects the Bonferroni correction needed for testing of all pairwise comparisons.||-5.57|-9.51|<0.0001
72453614|NCT00786864|144429695|SUPERIORITY_OR_OTHER||||||p=|0||95.0|||||ANCOVA|||||||p=0.001
72453615|NCT00786864|144429696|SUPERIORITY_OR_OTHER||||||p<|0||95.0|||||ANCOVA|||||||p<0.001
72453616|NCT00786864|144429697|SUPERIORITY_OR_OTHER||||||p<|0||95.0|||||ANCOVA|||||||p<0.001
72453617|NCT00786864|144429698|SUPERIORITY_OR_OTHER||||||p<|0||95.0|||||ANCOVA|||||||p<0.01
72453618|NCT03442777|144429735|SUPERIORITY||Risk Ratio (RR)|0.64||||0.04|TWO_SIDED|95.0|0.41|0.99||controlled for type of ward (ICU/Non-ICU)|Cochran-Mantel-Haenszel|||||0.99|0.41|0.04
72453619|NCT04732000|144429817|OTHER||Median Difference (Final Values)|-0.1373||||0.549|TWO_SIDED|||||The a priori threshold for statistical significance is \< 0.05.|Mann Whitney test, 2-sided|||||||0.5490
72453620|NCT01767467|144429845|NON_INFERIORITY|The objective was met if the lower limit of the 95% CI of the Geometric Mean (GM) ratio (GSK1437173A vaccine over placebo) for anti-gE ELISA antibody concentrations at Month 2 was greater than (\>) 3.|Adjusted Geometric Mean Concentration|29.75|||<|0.0001|TWO_SIDED|95.0|21.09|41.96||The p-value is relative to the null hypothesis Ho: Vaccine / Placebo = 1|Repeated measurement model|||The objective aimed to evaluate anti-gE humoral immune responses at Month 2 following a two-dose administration of the GSK1437173A vaccine, as compared to placebo, in subjects with haematologic malignancies excluding subjects with Non-Hodgkin B-cell Lymphoma and Chronic Lymphocytic Leukaemia.||41.96|21.09|<0.0001
72453621|NCT01787032|144429870|SUPERIORITY_OR_OTHER||Ratio|373.66|STANDARD_DEVIATION|13.2|||TWO_SIDED|90.0|346.029|403.507|||ANOVA|A bioequivalence acceptance range was not specified and no hypothesis was tested as the main focus was on estimation.|ANOVA model on the logarithmic scale: included effects accounting for following sources of variation: 'sequence', 'patients within sequence', 'period' and 'treatment'. Random effect: 'patients within sequences', others considered as fixed effects.|||403.507|346.029|
72453622|NCT01787032|144429870|SUPERIORITY_OR_OTHER||Ratio|266.94|STANDARD_DEVIATION|16.0|||TWO_SIDED|90.0|243.267|292.914|||ANOVA|A bioequivalence acceptance range was not specified and no hypothesis was tested as the main focus was on estimation.|ANOVA model on the logarithmic scale: included effects accounting for following sources of variation: 'sequence', 'patients within sequence', 'period' and 'treatment'. Random effect: 'patients within sequences', others considered as fixed effects.|||292.914|243.267|
72453623|NCT01787032|144429871|SUPERIORITY_OR_OTHER||Ratio|261.34|STANDARD_DEVIATION|37.3|||TWO_SIDED|90.0|211.692|322.633|||ANOVA|A bioequivalence acceptance range was not specified and no hypothesis was tested as the main focus was on estimation|ANOVA model on the logarithmic scale: included effects accounting for following sources of variation: 'sequence', 'patients within sequence', 'period' and 'treatment'. Random effect: 'patients within sequences', others considered as fixed effects.|||322.633|211.692|
72453624|NCT01787032|144429871|SUPERIORITY_OR_OTHER||Ratio|213.39|STANDARD_DEVIATION|34.1|||TWO_SIDED|90.0|175.783|259.051|||ANOVA|A bioequivalence acceptance range was not specified and no hypothesis was tested as the main focus was on estimation.|ANOVA model on the logarithmic scale: included effects accounting for following sources of variation: 'sequence', 'patients within sequence', 'period' and 'treatment'. Random effect: 'patients within sequences', others considered as fixed effects.|||259.051|175.783|
72453625|NCT01787032|144429872|SUPERIORITY_OR_OTHER||Ratio|372.88|STANDARD_DEVIATION|13.1|||TWO_SIDED|90.0|345.456|402.477|||ANOVA|A bioequivalence acceptance range was not specified and no hypothesis was tested as the main focus was on estimation.|ANOVA model on the logarithmic scale: included effects accounting for following sources of variation: 'sequence', 'patients within sequence', 'period' and 'treatment'. Random effect: 'patients within sequences', others considered as fixed effects.|||402.477|345.456|
72453626|NCT01787032|144429872|SUPERIORITY_OR_OTHER||Ratio|266.56|STANDARD_DEVIATION|16.0|||TWO_SIDED|90.0|242.955|292.456|||ANOVA|A bioequivalence acceptance range was not specified and no hypothesis was tested as the main focus was on estimation.|ANOVA model on the logarithmic scale: included effects accounting for following sources of variation: 'sequence', 'patients within sequence', 'period' and 'treatment'. Random effect: 'patients within sequences', others considered as fixed effects.|||292.456|242.955|
72453627|NCT02628626|144429944|SUPERIORITY|||||||0.85|||||||ANCOVA|||||||0.85
72453628|NCT02628626|144429945|SUPERIORITY|||||||0.24|||||||ANCOVA|||Approximately 4 weeks||||0.24
72453629|NCT02628626|144429946|SUPERIORITY|||||||0.44|||||||ANCOVA|||Approximately 4 weeks||||0.44
72499540|NCT01431287|144529524|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.077|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|0.051|0.102||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.102|0.051|<0.0001
72499541|NCT01431287|144529524|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.069|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|0.044|0.095||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.095|0.044|<0.0001
72499542|NCT01431287|144529524|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.042|STANDARD_ERROR_OF_MEAN|0.013||0.0013|TWO_SIDED|95.0|0.016|0.068||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.068|0.016|0.0013
72499543|NCT01431287|144529524|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.008|STANDARD_ERROR_OF_MEAN|0.013||0.5274|TWO_SIDED|95.0|-0.017|0.034||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.034|-0.017|0.5274
72499544|NCT01431287|144529524|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.078|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|0.052|0.103||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.103|0.052|<0.0001
72499545|NCT01431287|144529524|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.035|STANDARD_ERROR_OF_MEAN|0.013||0.0083|TWO_SIDED|95.0|0.009|0.06||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.060|0.009|0.0083
72499546|NCT01431287|144529524|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.007|STANDARD_ERROR_OF_MEAN|0.013||0.5744|TWO_SIDED|95.0|-0.018|0.033||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.033|-0.018|0.5744
72499547|NCT01431287|144529524|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.027|STANDARD_ERROR_OF_MEAN|0.013||0.0381|TWO_SIDED|95.0|0.001|0.053||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.053|0.001|0.0381
72499548|NCT01431287|144529525|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.081|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|0.055|0.108||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.108|0.055|<0.0001
72499549|NCT01431287|144529525|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.053|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|0.027|0.079||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.079|0.027|<0.0001
72499550|NCT01431287|144529525|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.065|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|0.039|0.091||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.091|0.039|<0.0001
72499551|NCT01431287|144529525|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.055|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|0.029|0.081||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.081|0.029|<0.0001
72499552|NCT01431287|144529525|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.037|STANDARD_ERROR_OF_MEAN|0.013||0.0052|TWO_SIDED|95.0|0.011|0.063||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.063|0.011|0.0052
72562370|NCT03566238|144656110|SUPERIORITY|"ANCOVA model including treatment, baseline pruritus score at AM and PM, PFIC type, and age category was used for treatment comparisons. A pooled analysis for the closed testing procedure was applied to control multiplicity. The one-sided adjusted p-value for an individual dose was calculated as the maximum value of the unadjusted p-value for the pooled analysis and the unadjusted p-value for the individual doses.~One-sided adjusted p-value was reported."|LS mean difference|21.71|STANDARD_ERROR_OF_MEAN|9.892||0.0163|TWO_SIDED|95.0|1.87|41.54|||ANCOVA|||Analysis of the Proportion of Positive Pruritus Assessments at Participant Level over the 24-Week Treatment Period - Albireo ObsRO Instrument (AM and PM Scores)||41.54|1.87|0.0163
72453630|NCT02628626|144429947|SUPERIORITY|||||||0.35|||||||ANCOVA|||||||0.35
72453631|NCT02628626|144429948|SUPERIORITY|||||||0.56|||||||ANCOVA|||Approximately 4 weeks||||0.56
72453632|NCT02628626|144429949|SUPERIORITY|||||||0.55|||||||ANCOVA|||||||0.55
72453633|NCT02628626|144429950|SUPERIORITY|||||||0.11|||||||ANCOVA|||Small (staining only)||||0.11
72453634|NCT02628626|144429950|SUPERIORITY|||||||0.06|||||||ANCOVA|||Moderate (requires change of underwear)||||0.06
72453635|NCT02628626|144429950|SUPERIORITY|||||||0.36|||||||ANCOVA|||Large (requires complete change of clothes)||||0.36
72453636|NCT02628626|144429951|SUPERIORITY|||||||0.18|||||||ANCOVA|||||||0.18
72453637|NCT02628626|144429952|SUPERIORITY|||||||0.04|||||||ANCOVA|||||||0.04
72453638|NCT02628626|144429953|SUPERIORITY|||||||0.29|||||||ANCOVA|||||||0.29
72453639|NCT02628626|144429954|SUPERIORITY|||||||0.39|||||||ANCOVA|||||||0.39
72453640|NCT02628626|144429955|SUPERIORITY|||||||0.07|||||||ANCOVA|||||||0.07
72453641|NCT02628626|144429956|SUPERIORITY|approximately 4 weeks post-treatment||||||0.12|||||||ANCOVA|||||||0.12
72453642|NCT02628626|144429957|SUPERIORITY|||||||0.67|||||||ANCOVA|||Lifestyle Score||||0.67
72453643|NCT02628626|144429957|SUPERIORITY|||||||0.8|||||||ANCOVA|||Coping Score||||0.80
72453644|NCT02628626|144429957|SUPERIORITY|||||||0.49|||||||ANCOVA|||Depression Score||||0.49
72453645|NCT02628626|144429957|SUPERIORITY|||||||0.6|||||||ANCOVA|||Embarrassment Score||||0.60
72453646|NCT02628626|144429958|SUPERIORITY|||||||0.78|||||||ANCOVA|||Approximately 4 weeks post-treatment||||0.78
72453647|NCT02063659|144430003|SUPERIORITY||Hodges-Lehman estimator of difference|-53.955|||<|0.001|TWO_SIDED|95.0|-84.955|-25.119|||Wilcoxon rank sum|||The primary analysis used a blocked 2-sample Wilcoxon rank sum statistic stratified by the u5-HIAA at randomization.|Mean difference is calculated as LX1606-Placebo.|-25.119|-84.955|< 0.001
72453648|NCT02063659|144430003|SUPERIORITY||Hodges-Lehman estimator of difference|-89.662|||<|0.001|TWO_SIDED|95.0|-113.104|-63.863|||Wilcoxon rank sum|||The primary analysis used a blocked 2-sample Wilcoxon rank sum statistic stratified by the u5-HIAA at randomization.|Mean difference is calculated as LX1606-Placebo.|-63.863|-113.104|< 0.001
72453649|NCT02921555|144430037|SUPERIORITY||Mean Difference (Final Values)|16.2||||0.05|TWO_SIDED|95.0|||||Chi-squared|||||||0.05
72453650|NCT02921555|144430037|SUPERIORITY|||||||0.05|||||||Chi-squared|||||||0.05
72453651|NCT03044158|144430059|SUPERIORITY||Rate Ratio (adjusted)|1.56|||||TWO_SIDED|95.0|1.21|2.01||||||||2.01|1.21|
72453652|NCT03044158|144430060|SUPERIORITY||Rate Ratio (adjusted)|1.28|||||TWO_SIDED|95.0|0.99|1.66||||||||1.66|0.99|
72453653|NCT03044158|144430061|SUPERIORITY||Geometric Mean Ratio (adjusted)|0.49|||||TWO_SIDED|95.0|0.39|0.62||||||||0.62|0.39|
72453654|NCT03044158|144430062|SUPERIORITY||Rate Ratio (adjusted)|1.48|||||TWO_SIDED|95.0|1.04|2.12||||||||2.12|1.04|
72453655|NCT03044158|144430063|SUPERIORITY||Geometric Mean Ratio (adjusted)|0.35|||||TWO_SIDED|95.0|0.21|0.56||||||||0.56|0.21|
72453656|NCT03044158|144430064|SUPERIORITY||Risk Ratio (RR)|0.77|||||TWO_SIDED|95.0|0.44|1.35||||||||1.35|0.44|
72453657|NCT01586104|144430128|OTHER|With 20 patients, there is 80% power to detect a difference of 100% with Standard lung RT versus 93% with IMRT assuming a standard deviation of 8 (as seen for the whole heart), a one tailed test and a Bonferroni correction for 4 statistical tests so that each test is done at p\<0.0125.|||||<|0.0125||||||The reported p value was calculated. The statistical analysis performed is attached to the outcome measure reported.|Bonferroni corrected at p<0.0125|||Feasibility will be defined as an enrolled patient receiving the IMRT treatment as planned. It is expected that the treatment will be feasible in at least 90% of patients. If the treatment is feasible in 16 or more out of 20 patients, then the treatment will be declared feasible. If the true feasibility rate is 90%, then there is a 4.3% chance that 15 or fewer feasible patients will be observed.|Lung-metastases-free survival will be estimated using Kaplan-Meier survival curves (minimum period of six months).|||<0.0125
72453658|NCT00092534|144430163|SUPERIORITY_OR_OTHER_LEGACY||Percent relative risk reduction|96.6||||||95.0|88.2|99.6|||||Confidence Interval (CI) based on binomial tail probabilities and not from a dispersion parameter|||99.6|88.2|
72453659|NCT04001829|144430190|SUPERIORITY|||||||0.27|||||||Fisher Exact|||||||0.27
72453660|NCT04001829|144430191|SUPERIORITY|||||||0.96|||||||t-test, 2 sided|||||||0.96
72453661|NCT04001829|144430192|SUPERIORITY|||||||0.004|||||||Fisher Exact|||||||0.004
72453662|NCT04001829|144430193|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||<0.001
72453663|NCT04001829|144430194|SUPERIORITY|||||||0.019|||||||Fisher Exact|||||||0.019
72453664|NCT04001829|144430195|SUPERIORITY|||||||0.47|||||||Fisher Exact|||||||0.47
72453665|NCT03678688|144430196|SUPERIORITY||EBA Ratio|0.689|||||TWO_SIDED|95.0|0.485|0.939|||||The confidence interval for the EBA ratio is estimated using Fieller's method.|||0.939|0.485|
72453666|NCT03678688|144430196|SUPERIORITY||EBA Ratio|0.689|||||TWO_SIDED|95.0|0.467|0.911|||||The confidence interval for the EBA ratio is estimated using Taylor's method.|||0.911|0.467|
72453667|NCT03678688|144430196|SUPERIORITY||EBA Ratio|0.759|||||TWO_SIDED|95.0|0.517|1.051|||||The confidence interval for the EBA ratio is estimated using Fieller's method.|||1.051|0.517|
72453668|NCT03678688|144430196|SUPERIORITY||EBA Ratio|0.759|||||TWO_SIDED|95.0|0.497|1.02|||||The confidence interval for the EBA ratio is estimated using Taylor's method.|||1.020|0.497|
72620188|NCT00452530|144771324|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.5||||0.0003||||||1-sided P-value|Yanagawa, Tango, and Hiejima test||Apixaban-enoxaparin|Sequential testing was used to control for overall type-I error and to compare the effect of apixaban with that of enoxaparin. Noninferiority (NI) of apixaban compared with enoxaparin for primary endpoint was tested first at 1-sided α=0.025 level. If superiority was demonstrated on the primary endpoint, NI was then tested on the secondary endpoint at a 1-sided α=0.025 level. If NI of the secondary endpoint was demonstrated, superiority was then tested at the 1-sided α=0.025 level.||||0.0003
72453669|NCT03678688|144430196|SUPERIORITY||EBA Ratio|0.745|||||TWO_SIDED|95.0|0.567|0.973|||||The confidence interval for the EBA ratio is estimated using Fieller's method.|||0.973|0.567|
72453670|NCT03678688|144430196|SUPERIORITY||EBA Ratio|0.745|||||TWO_SIDED|95.0|0.547|0.943|||||The confidence interval for the EBA ratio is estimated using Taylor's method.|||0.943|0.547|
72453671|NCT03678688|144430196|SUPERIORITY||EBA Ratio|0.605|||||TWO_SIDED|95.0|0.353|0.896|||||The confidence interval for the EBA ratio is estimated using Fieller's method.|||0.896|0.353|
72453672|NCT03678688|144430196|SUPERIORITY||EBA Ratio|0.605|||||TWO_SIDED|95.0|0.338|0.871|||||The confidence interval for the EBA ratio is estimated using Taylor's method.|||0.871|0.338|
72453673|NCT03678688|144430236|SUPERIORITY||EBA Ratio|1.256|||||TWO_SIDED|95.0|0.626|3.175|||||The confidence interval for the EBA ratio is estimated using Fieller's method.|||3.175|0.626|
72453674|NCT03678688|144430236|SUPERIORITY||EBA Ratio|1.256|||||TWO_SIDED|95.0|0.362|2.151|||||The confidence interval for the EBA ratio is estimated using Taylor's method.|||2.151|0.362|
72453675|NCT03678688|144430236|SUPERIORITY||EBA Ratio|1.385|||||TWO_SIDED|95.0|0.736|2.656|||||The confidence interval for the EBA ratio is estimated using Fieller's method.|||2.656|0.736|
72453676|NCT03678688|144430236|SUPERIORITY||EBA Ratio|1.385|||||TWO_SIDED|95.0|0.564|2.206|||||The confidence interval for the EBA ratio is estimated using Taylor's method.|||2.206|0.564|
72453677|NCT01354444|144430303|OTHER||Coefficient|1.48||||0.565|TWO_SIDED|95.0|-3.796|6.761|||Regression, Linear|||This analysis compares immediate recall before and after 6 months between the treatment and placebo group.||6.761|-3.796|0.565
72453678|NCT01354444|144430304|OTHER|||||||0.481|||||||Rank sum test|||This analysis compares the change in total Tau between the treatment and placebo group from baseline to 6 months later.||||0.481
72499553|NCT01431287|144529525|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.016|STANDARD_ERROR_OF_MEAN|0.013||0.2273|TWO_SIDED|95.0|-0.01|0.042||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.042|-0.010|0.2273
72453679|NCT01354444|144430304|OTHER|||||||0.0562|||||||Rank sum test|||This analysis compares the change in Abeta42 between the treatment and placebo group from baseline to 6 months later.||||0.0562
72453680|NCT01354444|144430304|OTHER|||||||0.314|||||||Rank sum test|||This analysis compares the change in p-tau between the treatment and placebo group from baseline to 6 months later.||||0.314
72453681|NCT01354444|144430304|OTHER|||||||0.438|||||||Rank sum test|||This analysis compares the change in oligomeric Abeta between the treatment and placebo group from baseline to 6 months later.||||0.438
72453682|NCT00982072|144430306|OTHER|||||||0.12|||||||Fisher Exact|||||||0.12
72453683|NCT04162210|144430311|OTHER||Stratified Hazard Ratio (HR)|1.03||||0.558|TWO_SIDED|95.0|0.72|1.47|||Log Rank|One-sided p-value from stratified log-rank test were adjusted for previous treatment with anti-CD38, ISS staging and number of prior lines of therapy.|HR was estimated using the Cox Proportional Hazards. HR stratified log-rank test were adjusted for previous treatment with anti-CD38, international staging system (ISS) staging and number of prior lines of therapy.|||1.47|0.72|0.558
72453684|NCT01478594|144430373|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.091||||0.706|TWO_SIDED|95.0|0.693|1.718|||Log Rank|Stratification factors were LDH status (\< 1.5 x ULN or ≥ 1.5 x ULN), origin of cancer (rectal or colon) and number of metastatic sites (1 or ≥ 2).|HR presented for the stratified analysis, which was based on the Cox proportional hazards model. Assuming proportional hazards, an HR \< 1 indicates a reduction in the HR in favor of tivozanib.|An interim futility analysis was to be performed when approximately 83 PFS events (50% of the total PFS events) were observed. The Lans DeMets beta spending function with an O'Brien-Fleming boundary was used to derive the futility boundary. If the hazard ratio (HR) for PFS was greater than 1.0581, enrollment was to be stopped. With this futility stopping rule, the adjusted study power was 78.6%.||1.718|0.693|0.706
72453685|NCT01478594|144430375|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.116||||0.754|TWO_SIDED|95.0|0.561|2.218|||Log Rank|Stratification factors were LDH status (\< 1.5 x ULN or ≥ 1.5 x ULN), origin of cancer (rectal or colon) and number of metastatic sites (1 or ≥ 2).|HR presented for the stratified analysis, which was based on the Cox proportional hazards model. Assuming proportional hazards, an HR \< 1 indicates a reduction in the HR in favor of tivozanib.|||2.218|0.561|0.754
72453686|NCT01478594|144430376|SUPERIORITY_OR_OTHER|||||||0.718|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratification factors were LDH status (\< 1.5 x ULN or ≥ 1.5 x ULN), origin of cancer (rectal or colon) and number of metastatic sites (1 or ≥ 2).||||||0.718
72453687|NCT01478594|144430377|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.389||||0.437|TWO_SIDED|95.0|0.604|3.194|||Log Rank|Stratification factors were LDH status (\< 1.5 x ULN or ≥ 1.5 x ULN), origin of cancer (rectal or colon) and number of metastatic sites (1 or ≥ 2).|HR presented for the stratified analysis, which was based on the Cox proportional hazards model. Assuming proportional hazards, an HR \< 1 indicates a reduction in the HR in favor of tivozanib.|||3.194|0.604|0.437
72453688|NCT01478594|144430378|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.006||||0.967|TWO_SIDED|95.0|0.746|1.358|||Log Rank|Stratification factors were LDH status (\< 1.5 x ULN or ≥ 1.5 x ULN), origin of cancer (rectal or colon) and number of metastatic sites (1 or ≥ 2).|HR presented for the stratified analysis, which was based on the Cox proportional hazards model. Assuming proportional hazards, an HR \< 1 indicates a reduction in the HR in favor of tivozanib.|||1.358|0.746|0.967
72453689|NCT01478594|144430381|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.331|||||TWO_SIDED|95.0|0.746|2.375|||||The hazard ratio was calculated using an unadjusted Cox proportional hazard model including treatment arms as the covariate. Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of Tivozanib arm.|||2.375|0.746|
72453690|NCT01478594|144430381|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.575|||||TWO_SIDED|95.0|0.285|1.16|||||The hazard ratio was calculated using an unadjusted Cox proportional hazard model including treatment arms as the covariate. Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of Tivozanib arm.|||1.160|0.285|
72620189|NCT00452530|144771324|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-1.04||||||95.0|-2.03|-0.05|||Inverse variance method|||Sequential testing was used to control for overall type-I error and to compare the effect of apixaban with that of enoxaparin. Noninferiority (NI) of apixaban compared with enoxaparin for primary endpoint was tested first at 1-sided α=0.025 level. If superiority was demonstrated on the primary endpoint, NI was then tested on the secondary endpoint at a 1-sided α=0.025 level. If NI of the secondary endpoint was demonstrated, superiority was then tested at the 1-sided α=0.025 level.||-0.05|-2.03|
72620190|NCT00452530|144771325|SUPERIORITY_OR_OTHER||Adjusted difference of event rates|-0.33||||0.3014|TWO_SIDED|95.0|-0.95|0.29|||Mantel Haenszel||Apixaban-enoxaparin|Major bleeding||0.29|-0.95|0.3014
72453691|NCT01478594|144430382|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.608|||||TWO_SIDED|95.0|0.635|4.073|||||The hazard ratio was calculated using an unadjusted Cox proportional hazard model including treatment arms as the covariate. Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of Tivozanib arm.|||4.073|0.635|
72453692|NCT01478594|144430382|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.755|||||TWO_SIDED|95.0|0.375|1.521|||||The hazard ratio was calculated using an unadjusted Cox proportional hazard model including treatment arms as the covariate. Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of Tivozanib arm.|||1.521|0.375|
72453693|NCT01478594|144430383|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.877|||||TWO_SIDED|95.0|0.366|2.1|||||The hazard ratio was calculated using an unadjusted Cox proportional hazard model including treatment arms as the covariate. Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of Tivozanib arm.|||2.100|0.366|
72453694|NCT01478594|144430383|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.275|||||TWO_SIDED|95.0|0.614|2.646|||||The hazard ratio was calculated using an unadjusted Cox proportional hazard model including treatment arms as the covariate. Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of Tivozanib arm.|||2.646|0.614|
72453695|NCT01478594|144430384|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.721|||||TWO_SIDED|95.0|0.345|1.507|||||The hazard ratio was calculated using an unadjusted Cox proportional hazard model including treatment arms as the covariate. Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of Tivozanib arm.|||1.507|0.345|
72453696|NCT01478594|144430384|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.597|||||TWO_SIDED|95.0|0.672|3.795|||||The hazard ratio was calculated using an unadjusted Cox proportional hazard model including treatment arms as the covariate. Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of Tivozanib arm.|||3.795|0.672|
72453697|NCT01478594|144430385|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.627|||||TWO_SIDED|95.0|0.58|4.564|||||The hazard ratio was calculated using an unadjusted Cox proportional hazard model including treatment arms as the covariate. Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of Tivozanib arm.|||4.564|0.580|
72453698|NCT01478594|144430385|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.779|||||TWO_SIDED|95.0|0.397|1.531|||||The hazard ratio was calculated using an unadjusted Cox proportional hazard model including treatment arms as the covariate. Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of Tivozanib arm.|||1.531|0.397|
72499554|NCT01431287|144529525|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.071|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|0.045|0.097||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.097|0.045|<0.0001
72453699|NCT01478594|144430386|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.946|||||TWO_SIDED|95.0|0.636|5.956|||||The hazard ratio was calculated using an unadjusted Cox proportional hazard model including treatment arms as the covariate. Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of Tivozanib arm.|||5.956|0.636|
72499555|NCT01431287|144529525|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.028|STANDARD_ERROR_OF_MEAN|0.013||0.033|TWO_SIDED|95.0|0.002|0.055||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.055|0.002|0.0330
72499556|NCT01431287|144529525|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.01|STANDARD_ERROR_OF_MEAN|0.013||0.4327|TWO_SIDED|95.0|-0.016|0.037||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.037|-0.016|0.4327
72453700|NCT01478594|144430386|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.806|||||TWO_SIDED|95.0|0.422|1.538|||||The hazard ratio was calculated using an unadjusted Cox proportional hazard model including treatment arms as the covariate. Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of Tivozanib arm.|||1.538|0.422|
72453701|NCT01478594|144430387|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.776|||||TWO_SIDED|95.0|0.303|1.991|||||The hazard ratio was calculated using an unadjusted Cox proportional hazard model including treatment arms as the covariate. Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of Tivozanib arm.|||1.991|0.303|
72453702|NCT01478594|144430387|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.241|||||TWO_SIDED|95.0|0.615|2.501|||||The hazard ratio was calculated using an unadjusted Cox proportional hazard model including treatment arms as the covariate. Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of Tivozanib arm.|||2.501|0.615|
72620191|NCT00452530|144771325|SUPERIORITY_OR_OTHER||Adjusted difference of event rates|-0.91||||0.1668|TWO_SIDED|95.0|-2.2|0.38|||Mantel Haenszel||Apixaban-enoxaparin|CRNM||0.38|-2.20|0.1668
72499557|NCT01431287|144529525|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.018|STANDARD_ERROR_OF_MEAN|0.013||0.1764|TWO_SIDED|95.0|-0.008|0.044||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.044|-0.008|0.1764
72499558|NCT01431287|144529526|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.056|STANDARD_ERROR_OF_MEAN|0.025||0.0241|TWO_SIDED|95.0|0.007|0.105||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.105|0.007|0.0241
72499559|NCT01431287|144529526|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.1|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.051|0.148||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.148|0.051|<0.0001
72499560|NCT01431287|144529526|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.07|STANDARD_ERROR_OF_MEAN|0.025||0.0049|TWO_SIDED|95.0|0.021|0.119||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.119|0.021|0.0049
72499561|NCT01431287|144529526|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.147|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.098|0.196||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.196|0.098|<0.0001
72499562|NCT01431287|144529526|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.113|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.064|0.162||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.162|0.064|<0.0001
72499563|NCT01431287|144529526|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.014|STANDARD_ERROR_OF_MEAN|0.025||0.5831|TWO_SIDED|95.0|-0.063|0.035||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.035|-0.063|0.5831
72499564|NCT01431287|144529526|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.133|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.084|0.182||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.182|0.084|<0.0001
72499565|NCT01431287|144529526|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.043|STANDARD_ERROR_OF_MEAN|0.025||0.0822|TWO_SIDED|95.0|-0.092|0.006||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.006|-0.092|0.0822
72499566|NCT01431287|144529526|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.077|STANDARD_ERROR_OF_MEAN|0.025||0.002|TWO_SIDED|95.0|-0.126|-0.028||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||-0.028|-0.126|0.0020
72499567|NCT01431287|144529526|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.034|STANDARD_ERROR_OF_MEAN|0.025||0.1774|TWO_SIDED|95.0|-0.015|0.083||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.083|-0.015|0.1774
72499568|NCT01431287|144529527|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.219|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.169|0.268||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.268|0.169|<0.0001
72620192|NCT00452530|144771325|SUPERIORITY_OR_OTHER||Adjusted difference of event rates|-1.24||||0.0881|TWO_SIDED|95.0|-2.66|0.18|||Mantel Haenszel||Apixaban-enoxaparin|Major or CRNM||0.18|-2.66|0.0881
72620193|NCT00452530|144771325|SUPERIORITY_OR_OTHER||Adjusted difference of event rates|-1.39||||0.1412|TWO_SIDED|95.0|-3.29|0.51|||Mantel Haenszel||Apixaban-enoxaparin|Any bleeding||0.51|-3.29|0.1412
72622460|NCT02214212|144774890|SUPERIORITY||Slope|-0.16||||0.955|TWO_SIDED|95.0|-5.69|5.37|||Mixed Models Analysis|Mixed-effects model used an unstructured correlation matrix, adjusting for treatment, time (linear) and the interaction as fixed effects.|The reported effect size has been expressed as the modelled difference in sleep efficiency improvement from day 1 to day 10. A positive effect size indicates a higher score in the white-light arm.|||5.37|-5.69|.955
72622461|NCT02214212|144774891|SUPERIORITY||Mean Difference (Net)|0.69||||0.807|TWO_SIDED|95.0|-4.9|6.29|||Mixed Models Analysis|||||6.29|-4.90|.807
72499569|NCT01431287|144529527|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.143|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.094|0.193||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.193|0.094|<0.0001
72499570|NCT01431287|144529527|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.209|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.16|0.258||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.258|0.160|<0.0001
72499571|NCT01431287|144529527|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.153|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.104|0.203||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.203|0.104|<0.0001
72499572|NCT01431287|144529527|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.134|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.084|0.183||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.183|0.084|<0.0001
72499573|NCT01431287|144529527|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.01|STANDARD_ERROR_OF_MEAN|0.025||0.6974|TWO_SIDED|95.0|-0.04|0.059||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.059|-0.040|0.6974
72499574|NCT01431287|144529527|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.163|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.114|0.213||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.213|0.114|<0.0001
72499575|NCT01431287|144529527|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.076|STANDARD_ERROR_OF_MEAN|0.025||0.0027|TWO_SIDED|95.0|0.026|0.125||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.125|0.026|0.0027
72499576|NCT01431287|144529527|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.056|STANDARD_ERROR_OF_MEAN|0.025||0.0269|TWO_SIDED|95.0|0.006|0.105||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.105|0.006|0.0269
72499577|NCT01431287|144529527|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.02|STANDARD_ERROR_OF_MEAN|0.025||0.4343|TWO_SIDED|95.0|-0.03|0.069||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.069|-0.030|0.4343
72499578|NCT01431287|144529528|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.198|STANDARD_ERROR_OF_MEAN|0.026|<|0.0001|TWO_SIDED|95.0|0.148|0.248||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.248|0.148|<0.0001
72499579|NCT01431287|144529528|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.146|STANDARD_ERROR_OF_MEAN|0.026|<|0.0001|TWO_SIDED|95.0|0.096|0.197||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.197|0.096|<0.0001
72499580|NCT01431287|144529528|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.208|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.158|0.258||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.258|0.158|<0.0001
72499581|NCT01431287|144529528|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.193|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.143|0.242||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.242|0.143|<0.0001
72499582|NCT01431287|144529528|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.156|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.106|0.206||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.206|0.106|<0.0001
72453703|NCT01478594|144430388|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.95|||||TWO_SIDED|95.0|0.343|2.63|||||The hazard ratio was calculated using an unadjusted Cox proportional hazard model including treatment arms as the covariate. Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of Tivozanib arm.|||2.630|0.343|
72391687|NCT02795832|144290802|SUPERIORITY|ANCOVA model was fitted with percent change from baseline to Week 2 in EASI score as the dependent variable. Explanatory variables fitted were: treatment group (ZPL-5212372, placebo) and baseline EASI score as a continuous variable.|Mean Difference (Net)|-11.72||||0.1284|TWO_SIDED|90.0|-28.85|5.51||The 1-sided p-value tests if the ZPL-5212372 LS mean is \< the placebo LS mean.|ANCOVA|||Day 5||5.51|-28.85|0.1284
72453704|NCT01478594|144430388|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.983|||||TWO_SIDED|95.0|0.503|1.918|||||The hazard ratio was calculated using an unadjusted Cox proportional hazard model including treatment arms as the covariate. Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of Tivozanib arm.|||1.918|0.503|
72453705|NCT01478594|144430389|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.226|||||TWO_SIDED|95.0|0.468|3.214|||||The hazard ratio was calculated using an unadjusted Cox proportional hazard model including treatment arms as the covariate. Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of Tivozanib arm.|||3.214|0.468|
72453706|NCT01478594|144430389|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.232|||||TWO_SIDED|95.0|0.447|3.396|||||The hazard ratio was calculated using an unadjusted Cox proportional hazard model including treatment arms as the covariate. Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of Tivozanib arm.|||3.396|0.447|
72453707|NCT01478594|144430390|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.803|||||TWO_SIDED|95.0|0.307|2.1|||||The hazard ratio was calculated using an unadjusted Cox proportional hazard model including treatment arms as the covariate. Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of Tivozanib arm.|||2.100|0.307|
72453708|NCT01478594|144430390|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.505|||||TWO_SIDED|95.0|0.585|3.873|||||The hazard ratio was calculated using an unadjusted Cox proportional hazard model including treatment arms as the covariate. Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of Tivozanib arm.|||3.873|0.585|
72453709|NCT01478594|144430391|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.921|||||TWO_SIDED|95.0|0.356|2.385|||||The hazard ratio was calculated using an unadjusted Cox proportional hazard model including treatment arms as the covariate. Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of Tivozanib arm.|||2.385|0.356|
72453710|NCT01478594|144430391|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.22|||||TWO_SIDED|95.0|0.462|3.22|||||The hazard ratio was calculated using an unadjusted Cox proportional hazard model including treatment arms as the covariate. Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of Tivozanib arm.|||3.220|0.462|
72453711|NCT01478594|144430392|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.915|||||TWO_SIDED|95.0|0.334|2.512|||||The hazard ratio was calculated using an unadjusted Cox proportional hazard model including treatment arms as the covariate. Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of Tivozanib arm.|||2.512|0.334|
72453712|NCT01478594|144430392|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.384|||||TWO_SIDED|95.0|0.554|3.455|||||The hazard ratio was calculated using an unadjusted Cox proportional hazard model including treatment arms as the covariate. Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of Tivozanib arm.|||3.455|0.554|
72453713|NCT01478594|144430393|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.538|||||TWO_SIDED|95.0|0.548|4.32|||||The hazard ratio was calculated using an unadjusted Cox proportional hazard model including treatment arms as the covariate. Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of Tivozanib arm.|||4.320|0.548|
72453714|NCT01478594|144430393|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.744|||||TWO_SIDED|95.0|0.299|1.85|||||The hazard ratio was calculated using an unadjusted Cox proportional hazard model including treatment arms as the covariate. Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of Tivozanib arm.|||1.850|0.299|
72453715|NCT03542305|144430421|OTHER||Ratio (%) of Adjusted Geometric Means|104.25|||||TWO_SIDED|90.0|79.73|136.31|||ANOVA|The natural log transformed parameter was used.|Normal renal function was the reference group. Mild renal impairment was test group. The estimate was derived from ratio (%) of adjusted geometric means of Test and Reference.|||136.31|79.73|
72499583|NCT01431287|144529528|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.01|STANDARD_ERROR_OF_MEAN|0.025||0.698|TWO_SIDED|95.0|-0.06|0.04||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.040|-0.060|0.6980
72453716|NCT03542305|144430421|OTHER||Ratio (%) of Adjusted Geometric Means|118.75|||||TWO_SIDED|90.0|91.43|154.24|||ANOVA|The natural log transformed parameter was used.|Normal renal function was the reference group. Moderate renal impairment was test group. The estimate was derived from ratio (%) of adjusted geometric means of Test and Reference.|||154.24|91.43|
72453717|NCT03542305|144430421|OTHER||Ratio (%) of Adjusted Geometric Means|141.14|||||TWO_SIDED|90.0|97.82|203.66|||ANOVA|The natural log transformed parameter was used.|Normal renal function was the reference group. Severe renal impairment was test group. The estimate was derived from ratio (%) of adjusted geometric means of Test and Reference.|||203.66|97.82|
72622462|NCT02214212|144774892|SUPERIORITY||Mean Difference (Net)|-0.48||||0.847|TWO_SIDED|95.0|-5.38|4.43|||Mixed Models Analysis|Mixed-effects model adjusts for treatment, time (pre/post), site, FIM admit cognitive/motor, and the treatment/time as fixed effects.||||4.43|-5.38|.847
72453718|NCT03542305|144430422|OTHER||Ratio (%) of Adjusted Geometric Means|100.53|||||TWO_SIDED|90.0|66.48|152.02|||ANOVA|The natural log transformed parameter was used.|Normal renal function was the reference group. Mild renal impairment was test group. The estimate was derived from ratio (%) of adjusted geometric means of Test and Reference.|||152.02|66.48|
72453719|NCT03542305|144430422|OTHER||Slope|88.87|||||TWO_SIDED|90.0|64.18|123.06|||ANOVA|The natural log transformed parameter was used.|Normal renal function was the reference group. Moderate renal impairment was test group. The estimate was derived from ratio (%) of adjusted geometric means of Test and Reference.|||123.06|64.18|
72453720|NCT03542305|144430422|OTHER||Ratio (%) of Adjusted Geometric Means|92.32|||||TWO_SIDED|90.0|56.58|150.63|||ANOVA|The natural log transformed parameter was used.|Normal renal function was the reference group. Severe renal impairment was test group. The estimate was derived from ratio (%) of adjusted geometric means of Test and Reference.|||150.63|56.58|
72453721|NCT02195232|144430455|OTHER|||||||0.92|||||||t-test, 2 sided|||||||0.92
72499584|NCT01431287|144529528|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.183|STANDARD_ERROR_OF_MEAN|0.026|<|0.0001|TWO_SIDED|95.0|0.132|0.233||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.233|0.132|<0.0001
72499585|NCT01431287|144529528|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.051|STANDARD_ERROR_OF_MEAN|0.026||0.0442|TWO_SIDED|95.0|0.001|0.102||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.102|0.001|0.0442
72499586|NCT01431287|144529528|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.015|STANDARD_ERROR_OF_MEAN|0.026||0.5514|TWO_SIDED|95.0|-0.035|0.065||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.065|-0.035|0.5514
72562371|NCT03566238|144656111|SUPERIORITY||proportion difference|0.435||||0.0015|TWO_SIDED|95.0|0.2195|0.6551|||Cochran-Mantel-Haenszel|||"Analysis was based on the Cochran Mantel Haenszel test adjusting PFIC type. A pooled analysis for the closed testing procedure was applied to control multiplicity. The one-sided adjusted p-value for an individual dose was calculated as the maximum value of the unadjusted p-value for the pooled analysis and the unadjusted p-value for the individual doses.~One-sided adjusted p-value was reported."||0.6551|0.2195|0.0015
72453722|NCT01759862|144430458|SUPERIORITY|Our calculations showed that by enrolling 50 patients we will be able to detect a 25cc/min absolute difference in eGFR between the two arms with power above 80%, and a two-sided Type I probability error of \<0.05.||||||0.32|||||||t-test, 2 sided|||Intention to treat analysis||||0.32
72453723|NCT01759862|144430459|SUPERIORITY|Enrolling 25 patients in each group will allow us to detect a difference of 200ng/mg cr in urinary NGAL levels between the two groups with a power of 80% and a two-sided type I probability error of 0.05.||||||0.95|||||||Kruskal-Wallis|||||||0.95
72453724|NCT01759862|144430460|SUPERIORITY|||||||0.67|||||||Chi-squared|||||||0.67
72453725|NCT00731614|144430461|SUPERIORITY_OR_OTHER_LEGACY|||||||0.322|||||||Repeated Measure ANOVA|||Conducted a repeated measures ANOVA comparing CBT+mirror retraining with Supportive Therapy across 11 time points. The primary hypothesis was a group by time interaction. Due to missing data, a total of 9 and 14 participants, respectively could be included in analyses.||||.322
72453726|NCT03229408|144430466|SUPERIORITY||||||<|0.004|||||||Unpaired t-test, 2-Sided|||||||<0.004
72453727|NCT03229408|144430467|SUPERIORITY||||||<|0.03|||||||Unpaired T-test, 2-Sided|||||||<0.03
72499587|NCT01431287|144529528|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.036|STANDARD_ERROR_OF_MEAN|0.026||0.1569|TWO_SIDED|95.0|-0.014|0.086||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.086|-0.014|0.1569
72622463|NCT02214212|144774893|SUPERIORITY||Mean Difference (Net)|3.14||||0.252|TWO_SIDED|95.0|-2.29|8.56|||Mixed Models Analysis|Statistical significance by mixed-effects regression adjusts for time (pre/post), site, FIM admit cognitive, FIM admit motor as fixed effects.||||8.56|-2.29|.252
72453728|NCT03229408|144430468|SUPERIORITY|||||||0.18|||||||Unpaired t-test, 2-Sided|||||||0.180
72622464|NCT02214212|144774894|SUPERIORITY||Mean Difference (Net)|0.67||||0.722|TWO_SIDED|95.0|-3.08|4.4|||Mixed Models Analysis|||||4.4|-3.08|.722
72453729|NCT03229408|144430469|SUPERIORITY||||||<|0.002|||||||Unpaired T-test, 2-Sided|||||||<0.002
72453730|NCT03229408|144430470|SUPERIORITY||||||<|0.04|||||||Unpaired t-test, 2-Sided|||||||<0.04
72453731|NCT03229408|144430471|SUPERIORITY||||||<|0.003|||||||Unpaired t-test, 2-Sided|||||||<0.003
72453732|NCT03229408|144430472|SUPERIORITY||||||<|0.0004|||||||Unpaired t-test, 2-Sided|||||||<0.0004
72453733|NCT03229408|144430473|SUPERIORITY||||||<|0.007|||||||Unpaired t-test, 2-Sided|||||||<0.007
72453734|NCT01532999|144430490|SUPERIORITY_OR_OTHER|||||||0.5|TWO_SIDED||||||Regression, Linear|||Three-level mixed-effects linear regression analysis comparing MBSR and PCGT groups over 9 weeks. Data structure involved repeated measures over time nested within participant, who in turn, was nested within a therapy group. Models included a random intercept, a random slope, and fixed effects for treatment condition, time, and the stratification variable (site). Rejection of the null hypothesis of no treatment effect if this interaction was statistically significant (two-tailed α = .05).||||0.5
72453735|NCT01532999|144430491|SUPERIORITY_OR_OTHER|||||||0.57|TWO_SIDED||||||Regression, Linear|||Three-level mixed-effects linear regression analysis comparing MBSR and PCGT groups over 9 weeks.||||0.57
72453736|NCT01532999|144430493|SUPERIORITY_OR_OTHER|||||||0.4|TWO_SIDED||||||Regression, Linear|||Three-level mixed-effects linear regression analysis comparing MBSR and PCGT groups over 9 weeks.||||0.4
72453737|NCT01532999|144430494|SUPERIORITY_OR_OTHER|||||||0.8|TWO_SIDED||||||Regression, Linear|||Three-level mixed-effects linear regression analysis comparing MBSR and PCGT groups over 9 weeks.||||0.8
72453738|NCT01532999|144430495|SUPERIORITY_OR_OTHER|||||||0.4|TWO_SIDED||||||Regression, Linear|||Three-level mixed-effects linear regression analysis comparing MBSR and PCGT groups over 9 weeks.||||0.4
72453739|NCT01532999|144430496|SUPERIORITY_OR_OTHER|||||||0.35|TWO_SIDED||||||Regression, Linear|||Three-level mixed-effects linear regression analysis comparing MBSR and PCGT groups over 9 weeks.||||0.35
72453740|NCT01532999|144430497|SUPERIORITY_OR_OTHER|||||||0.3|TWO_SIDED||||||Regression, Logistic|||Mixed effects logistic regression analysis.||||0.3
72622465|NCT02214212|144774895|SUPERIORITY||Mean Difference (Net)|-2.25||||0.253|TWO_SIDED|95.0|-6.13|1.64|||Mixed Models Analysis|||||1.64|-6.13|.253
72453741|NCT01532999|144430498|SUPERIORITY_OR_OTHER|||||||0.7|TWO_SIDED||||||Regression, Logistic|||Mixed effects logistic regression analysis.||||0.7
72453742|NCT05251363|144430517|SUPERIORITY||||||<|0.0001|||||||Exact binomial test|||Ho: SADE-free rate ≤ 87.5% Ha: SADE-free rate \> 87.5% Used an exact binomial test comparing the observed proportion (overall SADE-free rate through 3 months) to the performance goal of 87.5%. The lower, two-sided 95% confidence bound for the overall SADE-free rate must be greater than 87.5% to reject the null hypothesis (Ho), which would demonstrate evidence that the SADE-free rate is significantly higher than 87.5%.||||<0.0001
72453743|NCT05251363|144430518|SUPERIORITY||||||<|0.0001|||||||Exact binomial test|||H0: Implant Success Rate ≤ 80% Ha: Implant Success Rate \> 80% Used an exact binomial test comparing the observed proportion (implant success rate) to the performance goal of 80%. The lower, two-sided 95% confidence bound for the overall implant success rate must be greater than 80% to reject the null hypothesis (Ho), which would demonstrate evidence that the rate of successful Solia S LBBA implants is significantly higher than 80.0%.||||< 0.0001
72453744|NCT05251363|144430519|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||H0: Improvement in QOL Physical Function Scale ≤ 2.8 Ha: Improvement in QOL Physical Function Scale \> 2.8 Exact one-sample t-test comparing mean improvement in QOL from baseline to 12-mo post-implant to a goal of +2.8. The lower, two-sided 95% confidence bound for the improvement in QOL must be \> +2.8 to reject H0.||||<0.001
72453745|NCT01093612|144430531|OTHER||||||<|0.001|||||||Wilcoxon rank-sum|||||||<0.001
72453746|NCT01093612|144430532|OTHER||||||<|0.001|||||||Wilcoxon rank-sum|||||||<0.001
72453747|NCT03835754|144430533|OTHER|Confidence internal is 88.8%, upper bound limit 99.2%|Clopper Pearson exact confidence interva|96.0|||||TWO_SIDED|95.0|88.8|99.2||||||||99.2|88.8|
72453748|NCT05080777|144430585|EQUIVALENCE|Group, Time, and Group x Time effect tests were performed using MLM.||||||0.295||||||.P-value shown is based on the Group x Time F statistic used in multilevel modeling (MLM)|Multilevel modeling (MLM)|||Null hypothesis was that there would be no group differences, no time differences, and no group x time differences, in changes over time between the two treatment groups. Because this was a pilot and feasibility study, no power calculations were conducted.||||0.295
72453749|NCT05080777|144430586|EQUIVALENCE|Group, time, and group x time effect tests were performed using multilevel modeling (MLM).||||||0.57||||||P-value shown is based on the group x time F statistic used in MLM.|MLM|||Null hypothesis was that there would be no group differences, no time differences, and no group x time differences, in changes over time between the two treatment groups. Because this was a pilot and feasibility study, no power calculations were conducted.||||0.570
72453750|NCT05080777|144430587|EQUIVALENCE|Group, time, and time x group effect tests were performed using multilevel modeling (MLM).||||||0.461||||||P-value shown is based on the group x time F statistic used in MLM.|MLM|||Null hypothesis was that there would be no group differences, no time differences, and no group x time differences, in changes over time between the two treatment groups. Because this was a pilot and feasibility study, no power calculations were conducted.||||0.461
72453751|NCT04649047|144430590|NON_INFERIORITY|Paired T test (pre- post-)|Mean Difference (Final Values)|-2.92||||0.036|TWO_SIDED|95.0|-5.6|-0.23|||t-test, 2 sided|||||-0.23|-5.6|0.036
72453752|NCT04649047|144430591|NON_INFERIORITY|Paired T test (pre- post-)|Mean Difference (Final Values)|-0.56||||-0.77|TWO_SIDED|95.0|-1.02|-0.1|||t-test, 2 sided|||||-0.10|-1.02|-0.77
72453753|NCT04649047|144430592|NON_INFERIORITY|Paired T test (pre- post-)|Mean Difference (Final Values)|-3.42||||-0.51|TWO_SIDED|95.0|-7.69|0.85|||t-test, 2 sided|||||0.85|-7.69|-0.51
72453754|NCT04649047|144430593|NON_INFERIORITY|Paired T test (pre- post-)|Mean Difference (Final Values)|0.85||||0.49|TWO_SIDED|95.0|-0.32|2.03|||t-test, 2 sided|||||2.03|-0.32|0.49
72453755|NCT04649047|144430594|NON_INFERIORITY|Paired T test (pre- post-)|Mean Difference (Final Values)|-8.54||||-0.48|TWO_SIDED|95.0|-19.9|2.82|||t-test, 2 sided|||||2.82|-19.9|-0.48
72453756|NCT04649047|144430595|NON_INFERIORITY|Paired T test (pre- post-)|Mean Difference (Final Values)|64.46||||0.13|TWO_SIDED|95.0|-256.0|384.7|||t-test, 2 sided|||||384.7|-256|0.13
72622466|NCT02214212|144774896|SUPERIORITY||Mean Difference (Net)|-0.39||||0.351|TWO_SIDED|95.0|-1.21|0.44|||Mixed Models Analysis|Mixed-effects model adjusts for treatment, time (pre/post), site, FIM admit cognitive/motor, and the treatment/time as fixed effects.|A positive effect size indicates a higher score in the bright white light (BWL) intervention arm.|||0.44|-1.21|.351
72453757|NCT04649047|144430596|NON_INFERIORITY|Paired T test (pre- post-)|Mean Difference (Final Values)|3.5||||0.88|TWO_SIDED|95.0|0.98|6.02|||t-test, 2 sided|||||6.02|0.98|0.88
72453758|NCT04649047|144430597|NON_INFERIORITY|Paired T test (pre- post-)|Mean Difference (Final Values)|2.67||||0.61|TWO_SIDED|95.0|-0.1|4.94|||t-test, 2 sided|||||4.94|-0.10|0.61
72453759|NCT04649047|144430598|NON_INFERIORITY|Paired T test (pre- post-)|Mean Difference (Final Values)|4.5||||0.78|TWO_SIDED|95.0|0.82|8.18|||t-test, 2 sided|||||8.18|0.82|0.78
72453760|NCT04649047|144430599|NON_INFERIORITY|Paired T test (pre- post-)|Mean Difference (Final Values)|3.42||||0.58|TWO_SIDED|95.0|-0.32|7.16|||t-test, 2 sided|||||7.16|-0.32|0.58
72453761|NCT04649047|144430600|NON_INFERIORITY|Paired T test (pre- post-)|Mean Difference (Final Values)|2.42||||0.61|TWO_SIDED|95.0|-0.1|4.94|||t-test, 2 sided|||||4.94|-0.10|0.61
72453762|NCT04649047|144430601|NON_INFERIORITY|Paired T test (pre- post-)|Mean Difference (Final Values)|3.83||||0.46|TWO_SIDED|95.0|-1.5|9.16|||t-test, 2 sided|||||9.16|-1.50|0.46
72453763|NCT04649047|144430602|NON_INFERIORITY|Paired T test (pre- post-)|Mean Difference (Final Values)|4.08||||0.71|TWO_SIDED|95.0|0.43|7.73|||t-test, 2 sided|||||7.73|0.43|0.71
72453764|NCT04649047|144430603|NON_INFERIORITY|Paired T test (pre- post-)|Mean Difference (Final Values)|-3.67||||-0.52|TWO_SIDED|95.0|-8.12|0.79|||t-test, 2 sided|||||0.79|-8.12|-0.52
72453765|NCT05037513|144430614|SUPERIORITY||Odds Ratio (OR)|7.06|||<|0.05|TWO_SIDED|95.0|0.8|62.2|||Regression, Logistic|||||62.2|0.8|<0.05
72453766|NCT05037513|144430615|SUPERIORITY||Odds Ratio (OR)|7.06|||<|0.05|TWO_SIDED|95.0|0.8|62.2|||Regression, Logistic|||||62.2|0.8|<0.05
72453767|NCT01274338|144430644|SUPERIORITY|||||||0.065||||||This design provides at least 80% power at a one sided type I error rate of 0.003.|Log Rank|Stratified logrank test||This study has a two-step hierarchical approach. In the first step, the low-dose Ipi (LIP) will be compared with HDI. If the low-dose Ipi is significantly better than HDI, then the high-dose Ipi will be compared with HDI as a second step. When comparing the two investigational treatment groups, the primary comparison will be an intent to treat analysis of recurrence free survival (RFS; First Co-primary Endpoint) and overall survival (OS; Second Co-primary Endpoint).||||0.065
72453768|NCT01274338|144430645|SUPERIORITY|This design will provide 80% power to detect the difference between the two arms at a one-sided type I error rate of 0.022.||||||0.044|||||||Log Rank|Stratified logrank test||This study has a two-step hierarchical approach. In the first step, the low-dose Ipi (LIP) will be compared with HDI. If the low-dose Ipi is significantly better than HDI, then the high-dose Ipi will be compared with HDI as a second step. When comparing the two investigational treatment groups, the primary comparison will be an intent to treat analysis of recurrence free survival (RFS; First Co-primary Endpoint) and overall survival (OS; Second Co-primary Endpoint).||||0.044
72453769|NCT01274338|144430647|SUPERIORITY|||||||0.289||||||If low dose Ipi (LIP) vs. HDI is significant for OS at the 2.2% level, then we will compare high dose Ipi (HIP) vs. HDI at the 2.2% level.|Log Rank|Stratified logrank test||This study has a two-step hierarchical approach. In the first step, the low-dose Ipi (LIP) will be compared with HDI. If the low-dose Ipi is significantly better than HDI, then the high-dose Ipi will be compared with HDI as a second step. When comparing the two investigational treatment groups, the primary comparison will be an intent to treat analysis of recurrence free survival (RFS; First Co-primary Endpoint) and overall survival (OS; Second Co-primary Endpoint).||||0.289
72453770|NCT06072170|144430691|OTHER|Proportionality analysis was done using a power model.|Slope|0.829|||||TWO_SIDED|90.0|0.659|0.998||||||Statistical Analysis for Dose-Proportionality of Mitragynine Pharmacokinetic Parameters (Pharmacokinetic Population)||0.998|0.659|
72453771|NCT06072170|144430691|OTHER|Proportionality analysis was done using a power model.|Slope|0.843|||||TWO_SIDED|90.0|0.713|0.973||||||Statistical Analysis for Dose-Proportionality of 7-Hydroxy-Mitragynine Pharmacokinetic Parameters (Pharmacokinetic Population)||0.973|0.713|
72453772|NCT06072170|144430691|OTHER|Proportionality analysis was done using a power model.|Slope|0.811|||||TWO_SIDED|90.0|0.637|0.984||||||Statistical Analysis for Dose-Proportionality of Paynantheine Pharmacokinetic Parameters (Pharmacokinetic Population)||0.984|0.637|
72622467|NCT02214212|144774897|SUPERIORITY||Slope|0.0||||0.91|TWO_SIDED|95.0|-0.03|0.03|||Mixed Models Analysis|Mixed-effects model used an unstructured correlation matrix, adjusting for treatment, time (linear) and the interaction as fixed effects|The reported effect size has been expressed as the modelled difference in the Makley scale score improvement from day 1 to day 10. A positive effect size indicates a higher score in the white-light arm.|||0.03|-0.03|.910
72453773|NCT06072170|144430691|OTHER|Proportionality analysis was done using a power model.|Slope|0.814|||||TWO_SIDED|90.0|0.633|0.994||||||Statistical Analysis for Dose-Proportionality of Speciogynine Pharmacokinetic Parameters (Pharmacokinetic Population)||0.994|0.633|
72453774|NCT06072170|144430691|OTHER|Proportionality analysis was done using a power model.|Slope|0.88|||||TWO_SIDED|90.0|0.72|1.039||||||Statistical Analysis for Dose-Proportionality of Speciociliatine Dose Adjusted Pharmacokinetic Parameters (Pharmacokinetic Population)||1.039|0.720|
72453775|NCT06072170|144430693|OTHER|Proportionality analysis was done using a power model.|Slope|0.946|||||TWO_SIDED|90.0|0.768|1.123||||||Statistical Analysis for Dose-Proportionality of Mitragynine Pharmacokinetic Parameters (Pharmacokinetic Population)||1.123|0.768|
72453776|NCT06072170|144430693|OTHER|Proportionality analysis was done using a power model.|Slope|0.978|||||TWO_SIDED|90.0|0.821|1.134||||||Statistical Analysis for Dose-Proportionality of 7-Hydroxy-Mitragynine Pharmacokinetic Parameters (Pharmacokinetic Population)||1.134|0.821|
72453777|NCT06072170|144430693|OTHER|Proportionality analysis was done using a power model.|Slope|1.075|||||TWO_SIDED|90.0|0.901|1.249||||||Statistical Analysis for Dose-Proportionality of Paynantheine Pharmacokinetic Parameters (Pharmacokinetic Population)||1.249|0.901|
72453778|NCT06072170|144430693|OTHER|Proportionality analysis was done using a power model.|Slope|1.046|||||TWO_SIDED|90.0|0.87|1.222||||||Statistical Analysis for Dose-Proportionality of Speciogynine Pharmacokinetic Parameters (Pharmacokinetic Population)||1.222|0.870|
72453779|NCT06072170|144430693|OTHER|Proportionality analysis was done using a power model.|Slope|1.011|||||TWO_SIDED|90.0|0.844|1.178||||||Statistical Analysis for Dose-Proportionality of Speciociliatine Dose Adjusted Pharmacokinetic Parameters (Pharmacokinetic Population)||1.178|0.844|
72453780|NCT06072170|144430694|OTHER|Proportionality analysis was done using a power model.|Slope|0.959|||||TWO_SIDED|90.0|0.775|1.143||||||Statistical Analysis for Dose-Proportionality of Mitragynine Pharmacokinetic Parameters (Pharmacokinetic Population)||1.143|0.775|
72453781|NCT06072170|144430694|OTHER|Proportionality analysis was done using a power model.|Slope|0.974|||||TWO_SIDED|90.0|0.815|1.134||||||Statistical Analysis for Dose-Proportionality of 7-Hydroxy-Mitragynine Pharmacokinetic Parameters (Pharmacokinetic Population)||1.134|0.815|
72453782|NCT06072170|144430694|OTHER|Proportionality analysis was done using a power model.|Slope|1.036|||||TWO_SIDED|90.0|0.866|1.207||||||Statistical Analysis for Dose-Proportionality of Paynantheine Pharmacokinetic Parameters (Pharmacokinetic Population)||1.207|0.866|
72622468|NCT02214212|144774898|SUPERIORITY||Mean Difference (Net)|0.857||||0.19|TWO_SIDED|95.0|-1.93|2.32|||Mixed Models Analysis|Mixed-effects model adjusts for treatment time (pre/post)||||2.32|-1.93|0.19
72453783|NCT06072170|144430694|OTHER|Proportionality analysis was done using a power model.|Slope|0.967|||||TWO_SIDED|90.0|0.79|1.145||||||Statistical Analysis for Dose-Proportionality of Speciogynine Pharmacokinetic Parameters (Pharmacokinetic Population)||1.145|0.790|
72453784|NCT06072170|144430694|OTHER|Proportionality analysis was done using a power model.|Slope|1.025|||||TWO_SIDED|90.0|0.859|1.191||||||Statistical Analysis for Dose-Proportionality of Speciociliatine Dose Adjusted Pharmacokinetic Parameters (Pharmacokinetic Population)||1.191|0.859|
72453785|NCT06072170|144430698|SUPERIORITY||Least-Square Mean|18.5|STANDARD_ERROR_OF_MEAN|6.06|||TWO_SIDED|95.0|6.16|30.78||||||||30.78|6.16|
72453786|NCT06072170|144430701|SUPERIORITY||Least-Squared Mean|45.9|STANDARD_ERROR_OF_MEAN|7.74|<|0.001|TWO_SIDED|95.0|30.2|61.67|||ANOVA|||Statistical Analysis for High Visual Analog Scale (Emax)||61.67|30.20|<0.001
72453787|NCT02949297|144430710|OTHER|One-sided Clopper-Pearson 95% confidence interval|Clopper-Pearson|80.0|||||ONE_SIDED|95.0||95.0|||||One-sided Clopper-Pearson 95% confidence interval|||95||
72453788|NCT00458783|144430725|SUPERIORITY||Odds Ratio (OR)|0.77||||0.08|TWO_SIDED|95.0|0.5|1.2|||generalized estimating equation (GEE)|Generalized estimating equation (GEE) distinct-effects model||||1.2|0.50|0.08
72453789|NCT00458783|144430726|SUPERIORITY||Odds Ratio, log|0.64|||||TWO_SIDED|95.0|0.25|1.6||||||||1.6|0.25|
72453790|NCT00458783|144430727|SUPERIORITY||Odds Ratio, log|0.72|||||TWO_SIDED|95.0|0.26|2.0||||||||2.0|0.26|
72453791|NCT00458783|144430728|SUPERIORITY||Odds Ratio, log|0.9|||||TWO_SIDED|95.0|0.59|1.4||||||||1.4|0.59|
72453792|NCT00458783|144430729|SUPERIORITY||Odds Ratio, log|0.86|||||TWO_SIDED|95.0|0.43|1.8||||||||1.8|0.43|
72453793|NCT00458783|144430730|SUPERIORITY||Risk Ratio, log|0.81|||||TWO_SIDED|95.0|0.24|2.8||||||||2.8|0.24|
72453794|NCT00458783|144430731|SUPERIORITY||Odds Ratio, log|1.1|||||TWO_SIDED|95.0|0.8|1.5||||||||1.5|0.80|
72453795|NCT00458783|144430732|SUPERIORITY||Odds Ratio, log|0.43|||||TWO_SIDED|95.0|0.16|1.1||||||||1.1|0.16|
72453796|NCT00458783|144430733|SUPERIORITY||Odds Ratio, log|0.82|||||TWO_SIDED|95.0|0.39|1.7||||||||1.7|0.39|
72453797|NCT00458783|144430734|SUPERIORITY||Odds Ratio, log|0.82|||||TWO_SIDED|95.0|0.5|1.3||||||||1.3|0.50|
72453798|NCT00458783|144430735|SUPERIORITY||Odds Ratio, log|0.76|||||TWO_SIDED|95.0|0.18|3.2||||||||3.2|0.18|
72453799|NCT00458783|144430736|SUPERIORITY||Hazard Ratio (HR)|1.1||||0.9|TWO_SIDED|95.0|0.94|1.29|||Regression, Cox||The 95%CI is interim adjusted.|||1.29|0.94|0.9
72453800|NCT00458783|144430737|SUPERIORITY||Hazard Ratio (HR)|1.0||||0.07|TWO_SIDED|95.0|0.85|1.18|||Regression, Cox||The 95%CI is interim adjusted.|||1.18|0.85|0.07
72453801|NCT01737398|144430738|OTHER||Least Square Mean Difference|-19.73||||4e-08|TWO_SIDED|95.0|-26.43|-13.03|||MMRM|||||-13.03|-26.43|0.00000004
72453802|NCT01737398|144430739|OTHER||Least Square Mean Difference|-11.68||||0.0006|TWO_SIDED|95.0|-18.29|-5.06|||MMRM|||||-5.06|-18.29|0.0006
72453803|NCT00357994|144430800|SUPERIORITY_OR_OTHER||Treatment Difference (LS Mean)|-1.91|STANDARD_ERROR_OF_MEAN|0.57||0.0015|TWO_SIDED|95.0|-3.05|-0.76||Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding baseline and the natural logarithm of the mean daily dose of rescue medication on valid symptom diary days as covariates.|ANCOVA|||||-0.76|-3.05|0.0015
72453804|NCT00357994|144430801|SUPERIORITY_OR_OTHER||Treatment Difference (LS Mean)|1.86|STANDARD_ERROR_OF_MEAN|0.65||0.0059|TWO_SIDED|95.0|0.56|3.17|||ANCOVA|Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding baseline as a covariate.||Since the null hypothesis for the primary analysis was rejected in favor of the alternative hypothesis, hierarchical testing was performed for secondary variables on the Full Analysis data set at the 0.50 level using a gatekeeping procedure to preserve family-wise error rate.||3.17|0.56|0.0059
72453805|NCT00357994|144430802|SUPERIORITY_OR_OTHER||Treatment Difference (LS Mean)|-7.0|STANDARD_ERROR_OF_MEAN|2.8||0.0155|TWO_SIDED|95.0|-12.6|-1.4|||ANCOVA|Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding baseline as a covariate.||Since the null hypothesis for the primary analysis was rejected in favor of the alternative hypothesis, hierarchical testing was performed for secondary variables on the Full Analysis data set at the 0.50 level using a gatekeeping procedure to preserve family-wise error rate.||-1.4|-12.6|0.0155
72453806|NCT00357994|144430803|SUPERIORITY_OR_OTHER||Treatment Difference (LS Mean)|-0.7|STANDARD_ERROR_OF_MEAN|0.3||0.0258|TWO_SIDED|95.0|-1.4|-0.1|||ANCOVA|Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the baseline CGI-S as a covariate.||Since the null hypothesis for the primary analysis was rejected in favor of the alternative hypothesis, hierarchical testing was performed for secondary variables on the Full Analysis data set at the 0.50 level using a gatekeeping procedure to preserve family-wise error rate.||-0.1|-1.4|0.0258
72453807|NCT00357994|144430804|SUPERIORITY_OR_OTHER||Treatment Difference (LS Mean)|-3.0|STANDARD_ERROR_OF_MEAN|1.1||0.0086|TWO_SIDED|95.0|-5.3|-0.8|||ANCOVA|Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding baseline as a covariate.||Since the null hypothesis for the primary analysis was rejected in favor of the alternative hypothesis, hierarchical testing was performed for secondary variables on the Full Analysis data set at the 0.50 level using a gatekeeping procedure to preserve family-wise error rate.||-0.8|-5.3|0.0086
72453808|NCT00357994|144430805|SUPERIORITY_OR_OTHER||Treatment Difference (LS Mean)|1.4|STANDARD_ERROR_OF_MEAN|2.1||0.502|TWO_SIDED|95.0|-2.8|5.6|||ANCOVA|Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding baseline as a covariate.||Since the null hypothesis for the primary analysis was rejected in favor of the alternative hypothesis, hierarchical testing was performed for secondary variables on the Full Analysis data set at the 0.50 level using a gatekeeping procedure to preserve family-wise error rate.||5.6|-2.8|0.5020
72453809|NCT00357994|144430806|SUPERIORITY_OR_OTHER||Treatment Difference (LS Mean)|0.07|STANDARD_ERROR_OF_MEAN|0.038||0.067|TWO_SIDED|95.0|-0.005|0.146|||ANCOVA|Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding Baseline as a covariate.||Since the null hypothesis for the primary analysis was rejected in favor of the alternative hypothesis, hierarchical testing was performed for secondary variables on the Full Analysis data set at the 0.50 level using a gatekeeping procedure to preserve family-wise error rate.||0.146|-0.005|0.0670
72453810|NCT00357994|144430807|SUPERIORITY_OR_OTHER||Treament Difference (LS Mean)|-4.5|STANDARD_ERROR_OF_MEAN|3.1||0.1501|TWO_SIDED|95.0|-10.7|1.7|||ANCOVA|Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding baseline as a covariate.||Since the null hypothesis for the primary analysis was rejected in favor of the alternative hypothesis, hierarchical testing was performed for secondary variables on the Full Analysis data set at the 0.50 level using a gatekeeping procedure to preserve family-wise error rate.||1.7|-10.7|0.1501
72453811|NCT00357994|144430808|SUPERIORITY_OR_OTHER||Treatment Difference (LS Mean)|-0.08|STANDARD_ERROR_OF_MEAN|0.45||0.8574|TWO_SIDED|95.0|-0.98|0.82|||ANCOVA|Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding baseline as a covariate.||||0.82|-0.98|0.8574
72453812|NCT00357994|144430809|SUPERIORITY_OR_OTHER||Treatment Difference (LS Mean)|-10.4|STANDARD_ERROR_OF_MEAN|4.3||0.0184|TWO_SIDED|95.0|-19.1|-1.8|||ANCOVA|Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding baseline as a covariate.||||-1.8|-19.1|0.0184
72453813|NCT00357994|144430810|SUPERIORITY_OR_OTHER||Treatment Difference (LS Mean)|-11.6|STANDARD_ERROR_OF_MEAN|4.5||0.0129|TWO_SIDED|95.0|-20.6|-2.5|||ANCOVA|Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding baseline as a covariate.||||-2.5|-20.6|0.0129
72453814|NCT00357994|144430811|SUPERIORITY_OR_OTHER||Treatment Difference (LS Mean)|-2.2|STANDARD_ERROR_OF_MEAN|3.4||0.5246|TWO_SIDED|95.0|-9.0|4.6|||ANCOVA|Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding baseline as a covariate.||||4.6|-9.0|0.5246
72453815|NCT00357994|144430812|SUPERIORITY_OR_OTHER||Treatment Difference (LS Mean)|-4.5|STANDARD_ERROR_OF_MEAN|3.8||0.2423|TWO_SIDED|95.0|-12.0|3.1|||ANCOVA|Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding baseline as a covariate.||||3.1|-12.0|0.2423
72453816|NCT00357994|144430813|SUPERIORITY_OR_OTHER||Treatment Difference (LS Mean)|-3.8|STANDARD_ERROR_OF_MEAN|3.1||0.2243|TWO_SIDED|95.0|-9.9|2.4|||ANCOVA|Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding baseline as a covariate.||||2.4|-9.9|0.2243
72453817|NCT00357994|144430814|SUPERIORITY_OR_OTHER||Treatment Difference (LS Mean)|-4.0|STANDARD_ERROR_OF_MEAN|3.4||0.2407|TWO_SIDED|95.0|-10.8|2.8|||ANCOVA|Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding baseline as a covariate.||||2.8|-10.8|0.2407
72453818|NCT00357994|144430815|SUPERIORITY_OR_OTHER||Treatment Difference (LS Mean)|-13.8|STANDARD_ERROR_OF_MEAN|3.5||0.0002|TWO_SIDED|95.0|-20.8|-6.8|||ANCOVA|Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding baseline as a covariate.||||-6.8|-20.8|0.0002
72453819|NCT00357994|144430816|SUPERIORITY_OR_OTHER||Treatment Difference (LS Mean)|-3.3|STANDARD_ERROR_OF_MEAN|5.1||0.5213|TWO_SIDED|95.0|-13.6|6.9|||ANCOVA|Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding baseline as a covariate.||||6.9|-13.6|0.5213
72562372|NCT03566238|144656111|SUPERIORITY||proportion difference|0.211||||0.0174|TWO_SIDED|95.0|0.021|0.4557|||Cochran-Mantel-Haenszel|||Analysis was based on the Cochran Mantel Haenszel test adjusting PFIC type. A pooled analysis for the closed testing procedure was applied to control multiplicity. The one-sided adjusted p-value for an individual dose was calculated as the maximum value of the unadjusted p-value for the pooled analysis and the unadjusted p-value for the individual doses. One-sided adjusted p-value was reported.||0.4557|0.021|0.0174
72620194|NCT00452530|144771326|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.62|||<|0.0001|TWO_SIDED|95.0|0.51|0.74||P-value was statistically significant at the 1-sided 0.025 level|Yanagawa, Tango, and Hiejima test||Apixaban-enoxaparin|Sequential testing was used to control for overall type-I error and to compare the effect of apixaban with that of enoxaparin. Noninferiority (NI) of apixaban compared with enoxaparin for primary endpoint was tested first at 1-sided α=0.025 level. If NI on primary endpoint was demonstrated, superiority for the endpoint was then tested at 1-sided α=0.025 level. If superiority was demonstrated on the primary endpoint, NI was then tested on the key secondary endpoint at 1-sided α=0.025 level.||0.74|0.51|<0.0001
72453820|NCT00357994|144430817|SUPERIORITY_OR_OTHER||Treatment Difference (LS Mean)|0.3|STANDARD_ERROR_OF_MEAN|0.3||0.3741|TWO_SIDED|95.0|-0.4|0.9|||ANCOVA|Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding baseline as a covariate.||||0.9|-0.4|0.3741
72453821|NCT00357994|144430818|SUPERIORITY_OR_OTHER||Treatment Difference (LS Mean)|-1.2|STANDARD_ERROR_OF_MEAN|0.6||0.0361|TWO_SIDED|95.0|-2.4|-0.1|||ANCOVA|Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding baseline as a covariate.||||-0.1|-2.4|0.0361
72453822|NCT00357994|144430819|SUPERIORITY_OR_OTHER||Treatment Difference (LS Mean)|-0.4|STANDARD_ERROR_OF_MEAN|0.4||0.3578|TWO_SIDED|95.0|-1.1|0.4|||ANCOVA|Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding baseline as a covariate.||||0.4|-1.1|0.3578
72453823|NCT00357994|144430820|SUPERIORITY_OR_OTHER||Treatment Difference (LS Mean)|-1.5|STANDARD_ERROR_OF_MEAN|2.9||0.6088|TWO_SIDED|95.0|-7.4|4.4|||ANCOVA|Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding baseline as a covariate.||||4.4|-7.4|0.6088
72499588|NCT01431287|144529529|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.202|STANDARD_ERROR_OF_MEAN|0.026|<|0.0001|TWO_SIDED|95.0|0.15|0.253||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.253|0.150|<0.0001
72499589|NCT01431287|144529529|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.183|STANDARD_ERROR_OF_MEAN|0.026|<|0.0001|TWO_SIDED|95.0|0.132|0.234||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.234|0.132|<0.0001
72499590|NCT01431287|144529529|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.218|STANDARD_ERROR_OF_MEAN|0.026|<|0.0001|TWO_SIDED|95.0|0.167|0.269||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.269|0.167|<0.0001
72499591|NCT01431287|144529529|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.181|STANDARD_ERROR_OF_MEAN|0.026|<|0.0001|TWO_SIDED|95.0|0.13|0.232||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day\^interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.232|0.130|<0.0001
72562373|NCT00127166|144656129|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-3.25||||0.009||95.0|-5.66|-0.84|||ANOVA|Model terms: participant, treatment and period. The treatment test is adjusted for period||||-0.84|-5.66|0.009
72562374|NCT00127166|144656130|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-52.71||||0.006||95.0|-89.76|-15.66|||ANOVA|Model terms: participant, treatment and period. The treatment test is adjusted for period.||||-15.66|-89.76|0.006
72453824|NCT00357994|144430821|SUPERIORITY_OR_OTHER||Treatment Difference (LS Mean)|11.4|STANDARD_ERROR_OF_MEAN|3.7||0.0033|TWO_SIDED|95.0|4.0|18.9|||ANCOVA|Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding baseline as a covariate.||||18.9|4.0|0.0033
72453825|NCT03244800|144430824|SUPERIORITY||||||<|0.001|||||||ANCOVA|||||||<0.001
72453826|NCT03244800|144430825|SUPERIORITY|||||||0.002|||||||ANCOVA|||||||0.002
72453827|NCT03244800|144430826|SUPERIORITY||||||<|0.001|||||||ANCOVA|||||||<0.001
72453828|NCT03244800|144430827|SUPERIORITY||||||<|0.001|||||||ANCOVA|||||||<0.001
72453829|NCT03244800|144430828|SUPERIORITY|||||||0.002|||||||ANCOVA|||||||0.002
72453830|NCT03244800|144430829|SUPERIORITY||Odds Ratio (OR)|10.76||||0.04|TWO_SIDED|90.0|1.61|72.03|||Regression, Logistic|||||72.03|1.61|0.040
72562375|NCT00127166|144656131|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|4.11|||<|0.001||95.0|2.58|5.64|||ANCOVA|Participant, treatment, period \& covariate for FEV1 %-predicted Treatment test is adjusted for period \& FEV1 %-predicted at pre-exercise baseline||||5.64|2.58|<0.001
72562376|NCT00127166|144656132|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.26||||0.035||95.0|1.02|1.55|||Cox Proportional Hazards Model|Model terms: treatment and period|Dispersion not applicable to time to event data|||1.55|1.02|0.035
72562377|NCT00127166|144656133|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|3.8|||<|0.001||95.0|2.28|5.32|||ANOVA|Model terms: participant, treatment and period. The treatment test is adjusted for period.||||5.32|2.28|<0.001
72562378|NCT04728620|144656161|SUPERIORITY|single group|mean|79.3||||0.001|TWO_SIDED||||||t-test, 1 sided|||"One-sample t-test comparing the sample mean to the threshold value of 71 indicative of good usability. The null hypothesis: true mean is 71 or less."||||0.001
72562379|NCT04728620|144656163|OTHER||Mean Difference (Net)|0.57||||0.005|TWO_SIDED||||||t-test, 2 sided|||||||0.005
72562380|NCT04728620|144656164|OTHER||Mean Difference (Net)|-0.85||||0.19|TWO_SIDED||||||t-test, 2 sided|||||||0.19
72562381|NCT04728620|144656165|OTHER|||||||1|||||||McNemar|||Analysis for pre-post change in knowledge of recommended A1c monitoring frequency||||1
72562382|NCT04728620|144656165|OTHER|||||||1|||||||McNemar|||Analysis for pre-post change in knowledge of recommended urine microalbumin screening frequency||||1
72562383|NCT04728620|144656165|OTHER|||||||1|||||||McNemar|||Analysis for pre-post change in knowledge of recommended pneumonia vaccination frequency||||1
72562384|NCT04728620|144656165|OTHER|||||||1|||||||McNemar|||Analysis for pre-post change in knowledge of recommended diabetes eye exam frequency||||1
72562385|NCT04511208|144656176|SUPERIORITY||Difference in means|-2.2|||<|0.001|TWO_SIDED|95.0|-2.7|-1.7|||Repeated measures linear model|||||-1.7|-2.7|<0.001
72562386|NCT04511208|144656177|SUPERIORITY||Difference in means|-0.26||||0.006|TWO_SIDED|95.0|-0.44|-0.08|||Repeated measures linear model|||||-0.08|-0.44|0.006
72562387|NCT04511208|144656178|SUPERIORITY||Difference in means|-0.23||||0.046|TWO_SIDED|95.0|-0.45|-0.005|||Repeated measures linear model|||||-0.005|-0.45|0.046
72562388|NCT04511208|144656179|SUPERIORITY||Difference in means|-0.07||||0.955|TWO_SIDED|95.0|-2.51|2.38|||Repeated measures linear model|||C3B PST Score||2.38|-2.51|0.955
72620195|NCT00452530|144771326|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-9.27|||<|0.0001||95.0|-12.74|-5.79||P-value is statistically significant at the 1-sided 0.025 level|Yanagawa, Tango, and Hiejima test||Apixaban-enoxaparin|Sequential testing was used to control for overall type-I error and to compare the effect of apixaban with that of enoxaparin. Noninferiority (NI) of apixaban compared with enoxaparin for primary endpoint was tested first at 1-sided α=0.025 level. If NI on primary endpoint was demonstrated, superiority for the endpoint was then tested at 1-sided α=0.025 level. If superiority was demonstrated on the primary endpoint, NI was then tested on the key secondary endpoint at 1-sided α=0.025 level.||-5.79|-12.74|<0.0001
72620196|NCT01618708|144771331|SUPERIORITY_OR_OTHER||Least Squares (LS) Mean difference|0.07|||=|0.7462|TWO_SIDED|95.0|-0.38|0.52||Threshold for significance at 0.05 level|Mixed Models Analysis||Placebo vs Synvisc-One|Synvisc-One group was compared to placebo group using mixed model for repeated measures (MMRM) approach assuming missing data at random (MAR).||0.52|-0.38|= 0.7462
72562389|NCT04511208|144656179|SUPERIORITY||Difference in means|0.62||||0.686|TWO_SIDED|95.0|-2.48|3.71|||Repeated measures linear model|||C3B VMT Score||3.71|-2.48|0.686
72562390|NCT04511208|144656180|SUPERIORITY||Odds Ratio (OR)|2.5||||0.007|TWO_SIDED|95.0|1.28|4.68|||Generalized linear mixed effects model|||||4.68|1.28|0.007
72562391|NCT04511208|144656180|SUPERIORITY||Difference in means|-1.1||||0.009|TWO_SIDED|95.0|-1.82|-0.28|||Repeated measures linear model|||Sensitivity analysis||-0.28|-1.82|0.009
72562392|NCT04511208|144656181|SUPERIORITY||Difference in means|-1.06||||0.004|TWO_SIDED|95.0|-1.75|-0.38|||Repeated measures linear model|||||-0.38|-1.75|0.004
72562393|NCT04511208|144656182|SUPERIORITY||Difference in means|-2.97|||<|0.001|TWO_SIDED|95.0|-3.8|-2.13|||Repeated measures linear model|||||-2.13|-3.80|<0.001
72562394|NCT01634854|144656185|SUPERIORITY|||||||0.11|||||||Wilcoxon (Mann-Whitney)|||||||0.11
72562395|NCT01488448|144656192|SUPERIORITY_OR_OTHER|||||||0.73|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.73
72562396|NCT01488448|144656193|SUPERIORITY_OR_OTHER|||||||0.77|TWO_SIDED||||||Fisher Exact|||||||0.77
72562397|NCT01488448|144656194|SUPERIORITY_OR_OTHER|||||||0.97|TWO_SIDED||||||Fisher Exact|||||||0.97
72562398|NCT01488448|144656195|SUPERIORITY_OR_OTHER|||||||0.67|TWO_SIDED||||||Fisher Exact|||||||0.67
72562399|NCT01488448|144656196|SUPERIORITY_OR_OTHER|||||||0.39|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.39
72562400|NCT01488448|144656197|SUPERIORITY_OR_OTHER|||||||0.18|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.18
72562401|NCT01488448|144656200|SUPERIORITY_OR_OTHER|||||||0.96|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.96
72562402|NCT01362296|144656207|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.14||||0.5197|TWO_SIDED|95.0|0.75|1.75||P-value from the stratified log-rank was adjusted for gender (male versus female).|Log Rank||HRs were estimated using a Pike estimator. The HR from the stratified log-rank test was adjusted for gender (male versus female).|||1.75|0.75|0.5197
72562403|NCT02625974|144656227|OTHER|A direct comparison|Difference in cure rate|14.0|||||TWO_SIDED|95.0|3.7|24.2||||||||24.2|3.7|
72562404|NCT02625974|144656228|OTHER|Incidence rate and 95% CI of seronegative conversion|Risk Ratio (RR)|2.12|||||TWO_SIDED|95.0|1.21|3.45|||||Person-year = 754|||3.45|1.21|
72562405|NCT02625974|144656233|OTHER|Incidence rate and 95% CI of seronegative conversion|Risk Ratio (RR)|2.11|||||TWO_SIDED|95.0|0.91|4.16|||||Person-year = 379|||4.16|0.91|
72562406|NCT02875028|144656274|SUPERIORITY|||||||0.029|||||||Wilcoxon (Mann-Whitney)|||||||0.029
72562407|NCT01923311|144656292|EQUIVALENCE|A total of 12 test study participants compared to 334 HIV-infected reference study participants will provide at least 90% power to conclude exposure equivalence of EVG AUCtau in test study vs reference study, assuming the expected geometric mean ratio is 1, equivalency boundary is 70% to 143%, 2 one-sided tests are each performed at an alpha level of 0.05, and the standard deviation of EVG AUCtau is 0.36 ng•h/mL (natural log scale, estimated from EVG population PK modeling).|GLSM Ratio (%) (Test/Reference)|135.73|||||TWO_SIDED|90.0|116.24|158.49||||||To determine whether the proposed EVG dose in children achieved similar systemic exposure to adults, statistical comparisons were performed with PK data from the current study (test) and adult data from population PK modeling in study GS-US-183-0145 (NCT00708162) (reference).||158.49|116.24|
72453831|NCT05230433|144430859|OTHER||Percent Consumed|86.0||||0.15|TWO_SIDED|||||p-value was not adjusted for multiple comparisons|Chi-squared|||High fat agents were weighed pre- and post- providing the shake to the participant. All containers were tared to take into account straw, lid, and glass weight. Percentage of high-fat challenge consumed was calculated by post-shake weight / pre-shake weight. 13 out of 15 partcipants drank \>75% of the shake.||||0.15
72620197|NCT03319654|144771335|OTHER|A generalized estimating equation (GEE)-model with an exchangeable correlation structure and a logit link function was used to analyze the probability of live birth and clinical pregnancy respectively. All IUI cycles are used in this model with correction for the fact that cycles of the same couple are not independent.|Odds Ratio (OR)|0.94||||0.04|TWO_SIDED|95.0|0.9|0.9985|||GEE-model|||The null hypothesis is: there is no association between % total Sperm DNA Fragmentation and live birth.||0.9985|0.90|0.04
72620198|NCT03319654|144771335|OTHER||Area under the ROC curve|0.576|||>|0.05|TWO_SIDED||||||Receiver Operating Characteristics curve|||||||>0.05
72453832|NCT05230433|144430860|OTHER|No test vs. control groups.||||||0.65||||||This p-value is not adjusted for multiple comparisons.|Pearson Correlation|||Fold change from 60 to 180 minutes of average medium chain acylcarnitine was calculated for each participant. Pearson correlation between BMI percentile and fold change was calculated.|Pearson Correlation between both secondary outcomes reported: BMI percentile and fold change between acylcarnitine at 60 minutes and 180 minutes post the high fat challenge.|||0.65
72453833|NCT02927249|144430863|SUPERIORITY||Hazard Ratio (HR)|1.19|||||TWO_SIDED|95.0|0.91|1.56||||||||1.56|0.91|
72453834|NCT02927249|144430864|SUPERIORITY||Hazard Ratio (HR)|1.12|||||TWO_SIDED|95.0|0.74|1.69||||||||1.69|0.74|
72453835|NCT02927249|144430865|SUPERIORITY||Hazard Ratio (HR)|1.12|||||TWO_SIDED|95.0|0.83|1.52||||||||1.52|0.83|
72453836|NCT04250194|144430911|NON_INFERIORITY|The noninferiority margin was 10%.|absolute difference in percentage points|5.4||||0.003|TWO_SIDED|95.0|-6.5|17.2||The threshold for statistical significance was p = 0.05. The p value was not adjusted for multiple comparisons.|One-sided two-sample z-test||Difference in diagnostic accuracy = navigational bronchoscopy % - transthoracic biopsy %|||17.2|-6.5|0.003
72453837|NCT03387189|144430998|SUPERIORITY|Alpha - 0.05|Odds Ratio (OR)|0.39||||0.031|TWO_SIDED|95.0|0.17|0.91|||Regression, Logistic|Adjusted for length of second stage cesarean section, fetal station, delivery method, use of instrumentation , parity, and gestational age|Y = Intervention + Time + Intervention\*Time + Covariates. Provided estimation parameter is the OR from the interaction term and can be interpreted as the differential change in odds of outcome from pre to post period associated with the intervention.|||0.91|0.17|0.031
72453838|NCT03387189|144430999|SUPERIORITY|Alpha - 0.05|Odds Ratio (OR)|1.46||||0.465|TWO_SIDED|95.0|0.53|4.03|||Regression, Logistic|Adjusted for length of second stage cesarean section, fetal station, delivery method, use of instrumentation , parity, and gestational age|Y = Intervention + Time + Intervention\*Time + Covariates. Provided estimation parameter is the OR from the interaction term and can be interpreted as the differential change in odds of outcome from pre to post period associated with the intervention.|||4.03|0.53|0.465
72453839|NCT03387189|144431000|SUPERIORITY|alpha - 0.05|Mean Difference (Final Values)|-11.4||||0.01|TWO_SIDED|95.0|-20.4|-2.5|||t-test, 2 sided|||||-2.5|-20.4|0.01
72453840|NCT03387189|144431001|SUPERIORITY|Alpha - 0.05|Mean Difference (Final Values)|-1.0||||0.75|TWO_SIDED|95.0|-76.0|5.5|||t-test, 2 sided|||||5.5|-76.0|0.75
72453841|NCT03387189|144431002|SUPERIORITY|Alpha - 0.05|Mean Difference (Final Values)|-0.5||||0.02|TWO_SIDED|95.0|-1.0|-0.1|||t-test, 2 sided|||||-0.1|-1.0|0.02
72453842|NCT03387189|144431005|SUPERIORITY|Alpha - 0.05|Risk Difference (RD)|0.116||||0.1|TWO_SIDED|95.0|-0.01|0.24|||Fisher Exact|||||0.24|-0.01|0.10
72453843|NCT03387189|144431007|SUPERIORITY|Alpha - 0.05|Risk Difference (RD)|0.028||||0.81|TWO_SIDED|95.0|-0.12|17.8|||Fisher Exact|||||17.8|-0.12|0.81
72453844|NCT03387189|144431008|SUPERIORITY|Alpha - 0.05|Risk Ratio (RR)|0.01||||1|TWO_SIDED|95.0|-0.11|0.13|||Fisher Exact|||||0.13|-0.11|1.0
72622469|NCT02214212|144774899|SUPERIORITY||Mean Difference (Net)|-4.8||||0.345|TWO_SIDED|95.0|-14.83|5.24|||Mixed Models Analysis|Mixed-effects model adjusts for treatment, time (pre/post), FIM admit cognitive, site, FIM admit motor as mixed effects.||||5.24|-14.83|.345
72453845|NCT00291694|144431015|SUPERIORITY_OR_OTHER|||||||0.71|||||||Wilcoxon (Mann-Whitney)|||||||0.71
72453846|NCT00291694|144431016|SUPERIORITY_OR_OTHER|||||||0.053||||||Not adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|||Difference between groups, two-sided. Endpoint not specifically powered for effect.||||0.053
72453847|NCT00291694|144431017|SUPERIORITY_OR_OTHER|||||||0.37||||||Not adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|||||||0.37
72453848|NCT00291694|144431018|SUPERIORITY_OR_OTHER|||||||0.39||||||Not adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|||||||0.39
72453849|NCT00291694|144431019|SUPERIORITY_OR_OTHER|||||||0.37||||||Not adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|||||||0.37
72453850|NCT01367236|144431036|SUPERIORITY|||||||0.68|||||||Regression, Linear|||24 weeks||||0.68
72453851|NCT01367236|144431036|SUPERIORITY|||||||0.43|||||||Regression, Linear|||48 weeks||||0.43
72453852|NCT01367236|144431037|SUPERIORITY|||||||0.0009|||||||Regression, Linear|||||||0.0009
72453853|NCT02350634|144431043|OTHER||Correlation coefficient|0.429|||<|0.001|TWO_SIDED|||||A two-sided correlation test (rho ≠ 0) was performed with a significance level of alpha = 0.05 to assess a significant correlation.|Spearman's Rank Order Correlation test|||Null hypothesis is no correlation (correlation coefficient = 0)||||<0.001
72453854|NCT02350634|144431044|OTHER||Correlation coefficient|0.681|||<|0.001|TWO_SIDED|||||A two-sided correlation test (rho ≠ 0) was performed with a significance level of alpha = 0.05 to assess a significant correlation.|Spearman's Rank Order Correlation test|||Null hypothesis is no correlation (correlation coefficient = 0)||||<0.001
72453855|NCT02350634|144431045|OTHER||Correlation coefficient|0.644||||0.00278|TWO_SIDED|||||A two-sided correlation test (rho ≠ 0) was performed with a significance level of alpha = 0.05 to assess a significant correlation.|Spearman's Rank Order Correlation test|||Null hypothesis is no correlation (correlation coefficient = 0)||||0.00278
72453856|NCT02350634|144431046|OTHER||Correlation coefficient|0.437||||0.12|TWO_SIDED|||||A two-sided correlation test (rho ≠ 0) was performed with a significance level of alpha = 0.05 to assess a significant correlation.|Spearman's Rank Order Correlation test|||Null hypothesis is no correlation (correlation coefficient = 0)||||0.12
72453857|NCT02350634|144431047|OTHER||Correlation coefficient|0.324||||0.0712|TWO_SIDED|||||A two-sided correlation test (rho ≠ 0) was performed with a significance level of alpha = 0.05 to assess a significant correlation.|Spearman's Rank Order Correlation test|||Null hypothesis is no correlation (correlation coefficient = 0)||||0.0712
72453858|NCT02350634|144431048|OTHER||Correlation coefficient|0.564||||0.0958|TWO_SIDED|||||A two-sided correlation test (rho ≠ 0) was performed with a significance level of alpha = 0.05 to assess a significant correlation.|Spearman's Rank Order Correlation test|||Null hypothesis is no correlation (correlation coefficient = 0)||||0.0958
72453859|NCT02350634|144431049|OTHER||Correlation coefficient|-0.189||||0.558|TWO_SIDED|||||A two-sided correlation test (rho ≠ 0) was performed with a significance level of alpha = 0.05 to assess a significant correlation.|Spearman's Rank Order Correlation test|||Null hypothesis is no correlation (correlation coefficient = 0)||||0.558
72453860|NCT04241848|144431055|SUPERIORITY||||||=|0.007|||||||ANOVA|||Within-group comparison of Five Times Sit to Stand Test (5xSTS), from Baseline to after completing 36 training sessions. Assessed while not wearing the Powered Exoskeleton.||||=0.007
72453861|NCT04241848|144431055|SUPERIORITY||||||=|0.24|||||||ANOVA|||Within-group comparison of Five Times Sit to Stand Test (5xSTS), from Baseline to after completing 36 training sessions. Assessed while not wearing the Powered Exoskeleton.||||=0.240
72453862|NCT04241848|144431055|SUPERIORITY||||||=|0.04|||||||t-test, 2 sided|||Within-group comparison of Five Times Sit to Stand Test (5xSTS), from Baseline to after completing 36 training sessions. Assessed while wearing the Powered Exoskeleton.||||=0.04
72453863|NCT04241848|144431058|SUPERIORITY|||||||0.129|||||||ANOVA|||Within-group comparison of Six Minute Walk Test (6MWT), from Baseline to after completing 36 training sessions. Assessed while not wearing the Powered Exoskeleton.||||0.129
72453864|NCT04241848|144431058|SUPERIORITY|||||||0.25|||||||ANOVA|||Within-group comparison of Six Minute Walk Test (6MWT), from Baseline to after completing 36 training sessions. Assessed while not wearing the Powered Exoskeleton.||||0.250
72453865|NCT04241848|144431058|SUPERIORITY||||||=|0.073|||||||t-test, 2 sided|||Within-group comparison of Six Minute Walk Test (6MWT), from Baseline to after completing 36 training sessions. Assessed while wearing the Powered Exoskeleton.||||=0.073
72453866|NCT04241848|144431059|SUPERIORITY||||||=|0.091|||||||ANOVA|||Within-group comparison of Ten Meter Walk Test (10MWT), from Baseline to after completing 36 training sessions. Assessed while not wearing the Powered Exoskeleton.||||=0.091
72453867|NCT04241848|144431059|SUPERIORITY|||||||0.296|||||||ANOVA|||Within-group comparison of Ten Meter Walk Test (10MWT), from Baseline to after completing 36 training sessions. Assessed while not wearing the Powered Exoskeleton.||||0.296
72499592|NCT01431287|144529529|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.199|STANDARD_ERROR_OF_MEAN|0.026|<|0.0001|TWO_SIDED|95.0|0.148|0.25||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.250|0.148|<0.0001
72499593|NCT01431287|144529529|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.016|STANDARD_ERROR_OF_MEAN|0.026||0.5373|TWO_SIDED|95.0|-0.067|0.035||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.035|-0.067|0.5373
72499594|NCT01431287|144529529|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.165|STANDARD_ERROR_OF_MEAN|0.026|<|0.0001|TWO_SIDED|95.0|0.114|0.216||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.216|0.114|<0.0001
72499595|NCT01431287|144529529|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.019|STANDARD_ERROR_OF_MEAN|0.026||0.4763|TWO_SIDED|95.0|-0.033|0.07||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.070|-0.033|0.4763
72453868|NCT04241848|144431059|SUPERIORITY|||||||0.427|||||||t-test, 2 sided|||Within-group comparison of Ten Meter Walk Test (10MWT), from Baseline to after completing 36 training sessions. Assessed while wearing the Powered Exoskeleton.||||0.427
72453869|NCT04241848|144431060|SUPERIORITY|||||||0.063|||||||ANOVA|||Within-group comparison of Timed Up and Go (TUG) Test, from Baseline to after completing 36 training sessions. Assessed while not wearing the Powered Exoskeleton.||||0.063
72453870|NCT04241848|144431060|SUPERIORITY|||||||0.447|||||||ANOVA|||Within-group comparison of Timed Up and Go (TUG) Test, from Baseline to after completing 36 training sessions. Assessed while not wearing the Powered Exoskeleton.||||0.447
72453871|NCT04241848|144431060|SUPERIORITY|||||||0.096|||||||t-test, 2 sided|||Within-group comparison of Timed Up and Go (TUG) Test, from Baseline to after completing 36 training sessions. Assessed while wearing the Powered Exoskeleton.||||0.096
72453872|NCT04241848|144431061|SUPERIORITY|||||||0.035|||||||ANOVA|||Within-group comparison of Step Length of Paretic (Pa) Lower Extremities (LE), from Baseline to after completing 36 training sessions. Assessed while not wearing the Powered Exoskeleton.||||0.035
72453873|NCT04241848|144431061|SUPERIORITY||||||=|0.677|||||||ANOVA|||Within-group comparison of Step Length of Paretic (Pa) Lower Extremities (LE), from Baseline to after completing 36 training sessions. Assessed while not wearing the Powered Exoskeleton.||||=0.677
72453874|NCT04241848|144431061|SUPERIORITY||||||=|0.022|||||||t-test, 2 sided|||Within-group comparison of Step Length of Paretic (Pa) Lower Extremities (LE), from Baseline to after completing 36 training sessions. Assessed while wearing the Powered Exoskeleton.||||=0.022
72453875|NCT04241848|144431062|SUPERIORITY||||||=|0.098|||||||ANOVA|||Within-group comparison of Step lengths of the non-paretic (NP) Lower Extremities (LE), from Baseline to after completing 36 training sessions. Assessed while not wearing the Powered Exoskeleton.||||=0.098
72453876|NCT04241848|144431062|SUPERIORITY|||||||0.666|||||||ANOVA|||Within-group comparison of Step lengths of the non-paretic (NP) Lower Extremities (LE), from Baseline to after completing 36 training sessions. Assessed while not wearing the Powered Exoskeleton.||||0.666
72453877|NCT04241848|144431062|SUPERIORITY||||||=|0.007|||||||t-test, 2 sided|||Within-group comparison of Step lengths of the non-paretic (NP) Lower Extremities (LE), from Baseline to after completing 36 training sessions. Assessed while wearing the Powered Exoskeleton.||||=0.007
72453878|NCT04241848|144431063|SUPERIORITY||||||=|0.001|||||||ANOVA|||Within-group comparison of the Stair Climb Power Test (SCPT), from Baseline to after completing 36 training sessions. Assessed while not wearing the Powered Exoskeleton.||||=0.001
72453879|NCT04241848|144431063|SUPERIORITY||||||=|0.009|||||||ANOVA|||Within-group comparison of the Stair Climb Power Test (SCPT), from Baseline to after completing 36 training sessions. Assessed while not wearing the Powered Exoskeleton.||||=0.009
72453880|NCT04241848|144431063|SUPERIORITY|||||||0.018|||||||t-test, 2 sided|||Within-group comparison of the Stair Climb Power Test (SCPT), from Baseline to after completing 36 training sessions. Assessed while wearing the Powered Exoskeleton.||||0.018
72453881|NCT06307457|144431089|OTHER|||||||0.031|||||||Log Rank|||Statistical data for this outcome measure is provided combined for all age groups.||||0.031
72453882|NCT06307457|144431090|OTHER|||||||0.012|||||||Log Rank|||Statistical data for this outcome measure is provided combined for all age groups.||||0.012
72453883|NCT06307457|144431091|OTHER|||||||0.061|||||||Log Rank|||Statistical data for this outcome measure is provided combined for all CCI scores.||||0.061
72620199|NCT04128228|144771342|OTHER|"Single group: All individuals with alcohol use disorder received the same treatment.~Brain responses were examined at baseline in individuals with alcohol use disorder (AUD) with and without early trauma (AUD/ET, AUD/NT), as well as in moderate drinkers (MD) with and without early trauma (MD/ET, MD/NT)."|F value for the 2 X 2 Group Interaction|5.5|||<|0.05|TWO_SIDED|||||A 2 × 2 × 3 Linear Mixed Model was conducted with Early Trauma Group (ET, NT) and Drinking Group (AUD, MD) as between-subjects factors, and Condition (stress, alcohol, neutral) as the within-subjects factor.|Linear Mixed Model|||A regions of interest (ROI) analysis was conducted to evaluate brain activity in the right ventromedial prefrontal cortex (VmPFC, BA10), a region identified a priori. The VmPFC ROI was defined using the Yale-Brodmann atlas in the BioImage Suite application, from which the beta value for the VmPFC ROI was obtained for a Linear Mixed Model analysis.||||<0.05
72620200|NCT04128228|144771343|OTHER|Single group (all individuals with alcohol use disorder received the same treatment). Hormone responses were examined at baseline in individuals with alcohol use disorder (AUD) with and without early trauma (AUD/ET, AUD/NT), as well as in moderate drinkers (MD) with and without early trauma (MD/ET, MD/NT).|F value|4.79|||<|0.01|TWO_SIDED||||||ANOVA|||||||<0.01
72391688|NCT02795832|144290802|SUPERIORITY|ANCOVA model was fitted with percent change from baseline to Week 2 in EASI score as the dependent variable. Explanatory variables fitted were: treatment group (ZPL-5212372, placebo) and baseline EASI score as a continuous variable.|Mean Difference (Net)|-5.95||||0.2765|TWO_SIDED|90.0|-22.85|10.95||The 1-sided p-value tests if the ZPL-5212372 LS mean is \< the placebo LS mean.|ANCOVA|||Day 8||10.95|-22.85|0.2765
72453884|NCT06307457|144431092|OTHER|||||||0.08|||||||Log Rank|||Statistical data for this outcome measure is provided combined for all CCI scores.||||0.080
72453885|NCT06307457|144431093|OTHER|||||||0.2|||||||Log Rank|||Statistical data for this outcome measure is provided combined for all number of comorbidities.||||0.2
72453886|NCT06307457|144431094|OTHER|||||||0.093|||||||Log Rank|||Statistical data for this outcome measure is provided combined for all number of comorbidities.||||0.093
72453887|NCT06307457|144431095|OTHER||||||>|0.9|||||||Log Rank|||Statistical data for participants with cardiac disease comorbidity reported.||||>0.9
72453888|NCT06307457|144431095|OTHER|||||||0.9|||||||Log Rank|||Statistical data for participants with vascular disease comorbidity reported.||||0.9
72453889|NCT06307457|144431095|OTHER|||||||0.4|||||||Log Rank|||Statistical data for participants with metabolic disease comorbidity reported.||||0.4
72453890|NCT06307457|144431096|OTHER|||||||0.7|||||||Log Rank|||Statistical data for participants cardiac disease comorbidity reported.||||0.7
72453891|NCT06307457|144431096|OTHER|||||||0.3|||||||Log Rank|||Statistical data for participants with vascular disease comorbidity reported.||||0.3
72453892|NCT06307457|144431096|OTHER|||||||0.7|||||||Log Rank|||Statistical data for participants with metabolic disease comorbidity reported.||||0.7
72453893|NCT06307457|144431097|OTHER|||||||0.005|||||||Log Rank|||Statistical data for this outcome measure is provided combined for visceral disease status.||||0.005
72453894|NCT06307457|144431098|OTHER|||||||0.005|||||||Log Rank|||Statistical data for this outcome measure is provided combined for visceral disease status.||||0.005
72453895|NCT06307457|144431099|OTHER|||||||0.14|||||||Log Rank|||Statistical data for this outcome measure is provided combined for bone disease status.||||0.14
72453896|NCT06307457|144431100|OTHER|||||||0.2|||||||Log Rank|||Statistical data for this outcome measure is provided combined for bone disease status.||||0.2
72453897|NCT06307457|144431101|OTHER|||||||0.047|||||||Log Rank|||Statistical data for this outcome measure is provided combined for endocrine status.||||0.047
72453898|NCT06307457|144431102|OTHER|||||||0.041|||||||Log Rank|||Statistical data for this outcome measure is provided combined for endocrine status.||||0.041
72453899|NCT04401267|144431103|SUPERIORITY|||||||0.7139|||||||Fisher Exact|||||||0.7139
72453900|NCT02962284|144431118|SUPERIORITY||||||>|0.1|||||||ANCOVA|||||||>0.1
72453901|NCT01886872|144431143|SUPERIORITY||Hazard Ratio (HR)|0.39|||<|0.001|TWO_SIDED|95.0|0.26|0.58||(1-sided)|Log Rank|||Arm B (Ibrutinib) versus Arm A (Rituximab, Bendamustine Hydrochloride)||0.58|0.26|<0.001
72453902|NCT01886872|144431143|SUPERIORITY||Hazard Ratio (HR)|0.38|||<|0.001|TWO_SIDED|95.0|0.25|0.59||(1-sided)|Log Rank|||Arm C (Ibrutinib, Rituximab) versus Arm A (Rituximab, Bendamustine Hydrochloride)||0.59|0.25|<0.001
72453903|NCT01886872|144431143|SUPERIORITY||Hazard Ratio (HR)|1.0||||0.49|TWO_SIDED|95.0|0.62|1.62||(1-sided)|Log Rank|||Arm C (Ibrutinib, Rituximab) versus Arm B (Ibrutinib)||1.62|0.62|0.49
72469753|NCT01434680|144463238|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two-sided 95% CI for the ratio of the hSBA GMTs at 28 days following vaccination was within this equivalence interval for each of the two coprimary comparisons,MenC-CRM ROS and MenC-CRM EMV would be declared equivalent with respect to the immune response to the vaccines.|hSBA GMT ratios|1.14|||<|0.05|TWO_SIDED|95.0|0.92|1.41|||ANOVA|95% CIs for the GMTs ratios was obtained by exponentiating difference of least square means of log10-transformed titers and both the limits of 95% CIs||The study would be considered a success if the two-sided 95% confidence intervals (CIs) for the hSBA GMT ratios comparing MenC-CRM ROS to MenC-CRM EMV at 28 days after a single vaccination were both within the equivalence interval (0.5, 2.0).||1.41|0.92|<0.05
72453904|NCT04941482|144431153|SUPERIORITY||Median Difference (Net)|0.6|STANDARD_ERROR_OF_MEAN|1.3|<|0.05|TWO_SIDED|95.0|-1.9|3.2||The threshold for statistical significance was p = 0.05.|t-test, 2 sided||Treatment Difference = Intervention group - Control group|We calculated that 92 participants randomized in a 1:1 fashion between the 2 groups would have at least 80% power to detect a difference of 3.43 points in mean score in improving physical and mental health after stroke (based on J.Sims et al in 2008) between intervention and control groups from baseline to the 6th month. The sample size was determined using a 2-sided 2-sample t-test (a=0.05). Assumptions included a common standard deviation of 5.49 and a discontinuation rate of 10%.|(1) Variables with multiple measurements over time were compared using the repeated measures ANOVA test to assess changes in Patient Health Questionnaire-9 score before and after intervention in two groups, calculating the time\*group interaction; (2) Effect sizes after intervention are measured using Cohen's D, with values indicating small (d = 0.2), medium (d = 0.5), and large (d ≥ 0.8) effects.|3.2|-1.9|<0.05
72453905|NCT04941482|144431154|SUPERIORITY||Mean Difference (Net)|-2.6|STANDARD_ERROR_OF_MEAN|2.5|<|0.05|TWO_SIDED|95.0|-7.6|2.5||The threshold for statistical significance was p = 0.05.|t-test, 2 sided||Treatment Difference = Intervention group - Control group|We calculated that 92 participants randomized in a 1:1 fashion between the 2 groups would have at least 80% power to detect a difference of 3.43 points in mean score in improving physical and mental health after stroke (based on J.Sims et al in 2008) between intervention and control groups from baseline to the 6th month. The sample size was determined using a 2-sided 2-sample t-test (a=0.05). Assumptions included a common standard deviation of 5.49 and a discontinuation rate of 10%.|(1) Variables with multiple measurements over time were compared using the repeated measures ANOVA test to assess changes in Fatigue Severity Scale score before and after intervention in two groups, calculating the time\*group interaction; (2) Effect sizes after intervention are measured using Cohen's D, with values indicating small (d = 0.2), medium (d = 0.5), and large (d ≥ 0.8) effects.|2.5|-7.6|<0.05
72453906|NCT04941482|144431155|SUPERIORITY||Mean Difference (Net)|-2.1|STANDARD_ERROR_OF_MEAN|1.7|<|0.05|TWO_SIDED|95.0|-5.4|1.3||The threshold for statistical significance was p = 0.05.|t-test, 2 sided||Treatment Difference = Intervention group - Control group|We calculated that 92 participants randomized in a 1:1 fashion between the 2 groups would have at least 80% power to detect a difference of 3.43 points in mean score in improving physical and mental health after stroke (based on J.Sims et al in 2008) between intervention and control groups from baseline to the 6th month. The sample size was determined using a 2-sided 2-sample t-test (a=0.05). Assumptions included a common standard deviation of 5.49 and a discontinuation rate of 10%.|(1) Variables with multiple measurements over time were compared using the repeated measures ANOVA test to assess changes in Mini-Mental State Examinationscore before and after intervention in two groups, calculating the time\*group interaction; (2) Effect sizes after intervention are measured using Cohen's D, with values indicating small (d = 0.2), medium (d = 0.5), and large (d ≥ 0.8) effects.|1.3|-5.4|<0.05
72453907|NCT04941482|144431156|SUPERIORITY|Over 6 months, the number of patients who losted to follow-up of intervention and control group were respectively 9:0 (after 1 month), 9:0 (after 3 months), and 9:3 (after 6 months).|Mean Difference (Net)|0.1|STANDARD_ERROR_OF_MEAN|7.4|<|0.05|TWO_SIDED|95.0|-14.5|14.7|||t-test, 2 sided||Treatment Difference = Intervention group - Control group|We calculated that 92 participants randomized in a 1:1 fashion between the 2 groups would have at least 80% power to detect a difference of 3.43 points in mean score in improving physical and mental health after stroke (based on J.Sims et al in 2008) between intervention and control groups from baseline to the 6th month. The sample size was determined using a 2-sided 2-sample t-test (a=0.05). Assumptions included a common standard deviation of 5.49 and a discontinuation rate of 10%.|(1) Variables with multiple measurements over time were compared using the repeated measures ANOVA test to assess changes in Barthel Index score before and after intervention in two groups, calculating the time\*group interaction; (2) Effect sizes after intervention are measured using Cohen's D, with values indicating small (d = 0.2), medium (d = 0.5), and large (d ≥ 0.8) effects.|14.7|-14.5|<0.05
72469966|NCT01080300|144463899|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.21|STANDARD_ERROR_OF_MEAN|0.052|<|0.0001|TWO_SIDED|95.0|-0.31|-0.1||P-value for the test of difference of the least square mean change from baseline between Gabapentin ER 1800 mg and placebo group is based on the F-test of Type III analysis.|Based on Van Elteren|Multiplicity addressed by requiring significance for all primary endpoints.|Based on ANCOVA|"Baseline LOCF Average Daily Severity Score at Week 4:~Null hypothesis: no treatment differences relative to placebo in mean change from baseline in average daily severity score of moderate to severe hot flashes at Week 4."||-0.10|-0.31|<0.0001
72499596|NCT01431287|144529529|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.037|STANDARD_ERROR_OF_MEAN|0.026||0.1613|TWO_SIDED|95.0|-0.015|0.088||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.088|-0.015|0.1613
72499597|NCT01431287|144529529|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.018|STANDARD_ERROR_OF_MEAN|0.026||0.4908|TWO_SIDED|95.0|-0.069|0.033||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.033|-0.069|0.4908
72620201|NCT04128228|144771344|OTHER|Single Group|Hazard Ratio (HR)|0.71|||<|0.05|TWO_SIDED|95.0|0.53|0.95|||Regression, Cox|||||.95|.53|<0.05
72620202|NCT04128228|144771345|OTHER|Single Group. All individuals with alcohol use disorder received the same treatment.|t value|-3.35|||<|0.01|TWO_SIDED||||||t-test, 2 sided|||||||<0.01
72620203|NCT04128228|144771346|OTHER|Single Group (All individuals with alcohol use disorder received the same treatment.)|t value|-2.6|||<|0.05|TWO_SIDED||||||t-test, 2 sided|||||||<0.05
72620204|NCT03000166|144771347|SUPERIORITY|||||||0.22|||||||Mixed Models Analysis|||||||0.22
72620205|NCT03000166|144771348|SUPERIORITY|||||||0.4|||||||Mixed Models Analysis|||||||0.40
72620206|NCT03000166|144771349|SUPERIORITY|||||||0.17|||||||Mixed Models Analysis|||||||0.17
72620207|NCT03000166|144771350|SUPERIORITY|||||||0.2|||||||Mixed Models Analysis|||||||0.20
72499598|NCT01431287|144529530|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.122|STANDARD_ERROR_OF_MEAN|0.026|<|0.0001|TWO_SIDED|95.0|0.072|0.173||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.173|0.072|<0.0001
72453908|NCT04941482|144431157|SUPERIORITY||Mean Difference (Net)|-7.6|STANDARD_ERROR_OF_MEAN|5.6|<|0.05|TWO_SIDED|95.0|-18.8|3.7||The threshold for statistical significance was p \< 0.05.|t-test, 2 sided||Treatment Difference = Intervention group - Control group|We calculated that 92 participants randomized in a 1:1 fashion between the 2 groups would have at least 80% power to detect a difference of 3.43 points in mean score in improving physical and mental health after stroke (based on J.Sims et al in 2008) between intervention and control groups from baseline to the 6th month. The sample size was determined using a 2-sided 2-sample t-test (a=0.05). Assumptions included a common standard deviation of 5.49 and a discontinuation rate of 10%.|(1) Variables with multiple measurements over time were compared using the repeated measures ANOVA test to assess changes in Physical domain score of Stroke Impact Scale before and after intervention in two groups, calculating the time\*group interaction; (2) Effect sizes after intervention are measured using Cohen's D, with values indicating small (d = 0.2), medium (d = 0.5), and large (d ≥ 0.8) effects.|3.7|-18.8|<0.05
72453909|NCT04941482|144431158|SUPERIORITY||Mean Difference (Net)|-7.8|STANDARD_ERROR_OF_MEAN|-3.7|<|0.05|TWO_SIDED|95.0|-15.2|-0.3||The threshold for statistical significance was p = 0.05.|t-test, 2 sided||Treatment Difference = Intervention group - Control group|We calculated that 92 participants randomized in a 1:1 fashion between the 2 groups would have at least 80% power to detect a difference of 3.43 points in mean score in improving physical and mental health after stroke (based on J.Sims et al in 2008) between intervention and control groups from baseline to the 6th month. The sample size was determined using a 2-sided 2-sample t-test (a=0.05). Assumptions included a common standard deviation of 5.49 and a discontinuation rate of 10%.|(1) Variables with multiple measurements over time were compared using the repeated measures ANOVA test to assess changes in Stroke Impact Scale score before and after intervention in two groups, calculating the time\*group interaction; (2) Effect sizes after intervention are measured using Cohen's D, with values indicating small (d = 0.2), medium (d = 0.5), and large (d ≥ 0.8) effects.|-0.3|-15.2|<0.05
72453910|NCT02962102|144431190|SUPERIORITY|||||||0.52|||||||Fisher Exact|||||||0.52
72453911|NCT02962102|144431190|SUPERIORITY|||||||0.58|||||||Fisher Exact|||||||0.58
72453912|NCT02962102|144431191|SUPERIORITY|||||||0.2|||||||Fisher Exact|||||||0.20
72453913|NCT02962102|144431191|SUPERIORITY|||||||0.2|||||||Fisher Exact|||||||0.20
72453914|NCT02962102|144431192|SUPERIORITY|||||||0.44|||||||Wilcoxon (Mann-Whitney)|||||||0.44
72453915|NCT02962102|144431192|SUPERIORITY|||||||0.29|||||||Wilcoxon (Mann-Whitney)|||||||0.29
72453916|NCT05785832|144431220|SUPERIORITY||Mean Difference (Net)|-0.6|||<|0.001|TWO_SIDED|95.0|-0.8|-0.4|||Regression, Linear|||Adjusted Difference Between Groups||-0.4|-0.8|<0.001
72453917|NCT05785832|144431221|SUPERIORITY||Mean Difference (Net)|14.0|||<|0.001|TWO_SIDED|95.0|11.0|17.0|||Regression, Linear|||Adjusted Difference Between Groups||17|11|<0.001
72453918|NCT05785832|144431222|SUPERIORITY||Mean Difference (Net)|-21.0|||<|0.001|TWO_SIDED|95.0|-26.0|-15.0|||Regression, Linear|||Adjusted Difference Between Groups||-15|-26|<0.001
72453919|NCT05785832|144431223|SUPERIORITY||Mean Difference (Net)|-14.0|||<|0.001|TWO_SIDED|95.0|-17.0|-11.0|||Regression, Linear|||Adjusted Difference Between Groups||-11|-17|<0.001
72453920|NCT05785832|144431224|SUPERIORITY||Mean Difference (Net)|-9.1|||<|0.001|TWO_SIDED|95.0|-11.7|-6.6|||Regression, Linear|||Adjusted Difference Between Groups||-6.6|-11.7|<0.001
72453921|NCT05785832|144431225|SUPERIORITY||Mean Difference (Net)|-0.7|||<|0.001|TWO_SIDED|95.0|-1.0|-0.4|||Regression, Linear|||Adjusted Difference Between Groups||-0.4|-1.0|<0.001
72453922|NCT05785832|144431226|SUPERIORITY||Mean Difference (Net)|-0.1|||||TWO_SIDED|95.0|-0.4|0.1||A hierarchical procedure was used to control for the overall type I error. Since the P value for this outcome was more than 0.05, no additional P values are provided for subsequent secondary outcomes.|Regression, Linear|||Adjusted Difference Between Groups||0.1|-0.4|
72453923|NCT05785832|144431227|SUPERIORITY||Mean Difference (Net)|-0.02|||||TWO_SIDED|95.0|-0.09|0.04|||Regression, Linear|||Adjusted Difference Between Groups||0.04|-0.09|
72453924|NCT05785832|144431228|SUPERIORITY||Mean Difference (Net)|0.0|||||TWO_SIDED|95.0|-0.1|0.0|||Regression, Linear|||Adjusted Difference Between Groups||0.0|-0.1|
72453925|NCT05785832|144431229|SUPERIORITY||Mean Difference (Net)|0.3|||||TWO_SIDED|95.0|-0.5|1.2|||Regression, Linear|||Adjusted Difference Between Groups||1.2|-0.5|
72499599|NCT01431287|144529530|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.063|STANDARD_ERROR_OF_MEAN|0.026||0.0154|TWO_SIDED|95.0|0.012|0.113||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.113|0.012|0.0154
72499600|NCT01431287|144529530|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.13|STANDARD_ERROR_OF_MEAN|0.026|<|0.0001|TWO_SIDED|95.0|0.08|0.181||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.181|0.080|<0.0001
72499601|NCT01431287|144529530|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.084|STANDARD_ERROR_OF_MEAN|0.026||0.0012|TWO_SIDED|95.0|0.033|0.134||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.134|0.033|0.0012
72620208|NCT05226884|144771389|NON_INFERIORITY|Non-inferiority defined as within 0.1 LogMAR (1 line on Snellen Chart).|||||<|0.05|||||||Wilcoxon (Mann-Whitney)|Normality was assumed if skewness was ±2 and kurtosis was ±7. Non-inferiority was confirmed before further statistical testing.||||||<0.05
72620209|NCT05226884|144771390|NON_INFERIORITY|Non-inferiority defined as within 0.1 LogMAR (1 line on Snellen Chart).|||||<|0.05|||||||Wilcoxon (Mann-Whitney)|Normality was assumed if skewness was ±2 and kurtosis was ±7. Non-inferiority was confirmed before further statistical testing.||||||<0.05
72453926|NCT05785832|144431230|SUPERIORITY||Difference in percent of participants.|12.0|||||TWO_SIDED|95.0|1.0|21.0|||||Estimation represents the difference in percent of participants in each arm who achieved the outcome.|||21|1|
72453927|NCT05785832|144431231|SUPERIORITY||Difference in percent of participants.|18.0|||||TWO_SIDED|95.0|2.0|32.0|||||Estimation represents the difference in percent of participants in each arm who achieved the outcome.|||32|2|
72453928|NCT05785832|144431232|SUPERIORITY||Difference in percent of participants.|23.0|||||TWO_SIDED|95.0|12.0|33.0|||||Estimation represents the difference in percent of participants in each arm who achieved the outcome.|||33|12|
72453929|NCT05785832|144431233|SUPERIORITY||Difference in percent of participants.|25.0|||||TWO_SIDED|95.0|11.0|38.0|||||Estimation represents the difference in percent of participants in each arm who achieved the outcome.|||38|11|
72453930|NCT05785832|144431234|SUPERIORITY||Difference in percent of participants.|22.0|||||TWO_SIDED|95.0|11.0|33.0|||||Estimation represents the difference in percent of participants in each arm who achieved the outcome.|||33|11|
72499602|NCT01431287|144529530|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.071|STANDARD_ERROR_OF_MEAN|0.026||0.0061|TWO_SIDED|95.0|0.02|0.121||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.121|0.020|0.0061
72499603|NCT01431287|144529530|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.008|STANDARD_ERROR_OF_MEAN|0.026||0.7518|TWO_SIDED|95.0|-0.059|0.042||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.042|-0.059|0.7518
72499604|NCT01431287|144529530|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.076|STANDARD_ERROR_OF_MEAN|0.026||0.0034|TWO_SIDED|95.0|0.025|0.126||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.126|0.025|0.0034
72499605|NCT01431287|144529530|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.059|STANDARD_ERROR_OF_MEAN|0.026||0.0209|TWO_SIDED|95.0|0.009|0.11||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.110|0.009|0.0209
72499606|NCT01431287|144529530|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.047|STANDARD_ERROR_OF_MEAN|0.026||0.0708|TWO_SIDED|95.0|-0.004|0.097||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.097|-0.004|0.0708
72499607|NCT01431287|144529530|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.013|STANDARD_ERROR_OF_MEAN|0.026||0.6148|TWO_SIDED|95.0|-0.038|0.064||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.064|-0.038|0.6148
72499608|NCT01431287|144529531|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.164|STANDARD_ERROR_OF_MEAN|0.026|<|0.0001|TWO_SIDED|95.0|0.114|0.215||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.215|0.114|<0.0001
72499609|NCT01431287|144529531|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.071|STANDARD_ERROR_OF_MEAN|0.026||0.0064|TWO_SIDED|95.0|0.02|0.122||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.122|0.020|0.0064
72499610|NCT01431287|144529531|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.152|STANDARD_ERROR_OF_MEAN|0.026|<|0.0001|TWO_SIDED|95.0|0.102|0.203||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.203|0.102|<0.0001
72499611|NCT01431287|144529531|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.075|STANDARD_ERROR_OF_MEAN|0.026||0.0035|TWO_SIDED|95.0|0.025|0.126||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.126|0.025|0.0035
72620210|NCT05226884|144771391|NON_INFERIORITY|Non-inferiority defined as within 0.1 LogMAR (1 line on Snellen Chart).|||||<|0.05|||||||Wilcoxon (Mann-Whitney)|Normality was assumed if skewness was ±2 and kurtosis was ±7. Non-inferiority was confirmed before further statistical testing.||||||<0.05
72620211|NCT05226884|144771392|NON_INFERIORITY|Non-inferiority defined as within 0.1 LogMAR (1 line on Snellen Chart).|||||||||||||||||The defocus curve is generated based on measurements over a dioptric range.|||
72453931|NCT05785832|144431235|SUPERIORITY||Difference in percent of participants.|21.0|||||TWO_SIDED|95.0|10.0|32.0|||||Estimation represents the difference in percent of participants in each arm who achieved the outcome.|||32|10|
72453932|NCT05785832|144431236|SUPERIORITY||Difference in percent of participants.|21.0|||||TWO_SIDED|95.0|9.0|31.0|||||Estimation represents the difference in percent of participants in each arm who achieved the outcome.|||31|9|
72453933|NCT05785832|144431237|SUPERIORITY||Median Difference (Net)|10.0|||||TWO_SIDED|95.0|7.0|12.0||||||Adjusted Difference Between Groups||12|7|
72620212|NCT05226884|144771393|NON_INFERIORITY|Non-inferiority defined as within 0.1 LogMAR (1 line on Snellen Chart).|||||<|0.05|||||||Wilcoxon (Mann-Whitney)|Normality was assumed if skewness was ±2 and kurtosis was ±7. Non-inferiority was confirmed before further statistical testing.||||||<0.05
72391689|NCT02795832|144290802|SUPERIORITY|ANCOVA model was fitted with percent change from baseline to Week 2 in EASI score as the dependent variable. Explanatory variables fitted were: treatment group (ZPL-5212372, placebo) and baseline EASI score as a continuous variable.|Mean Difference (Net)|-6.01||||0.2765|TWO_SIDED|90.0|-23.08|11.06||The 1-sided p-value tests if the ZPL-5212372 LS mean is \< the placebo LS mean.|ANCOVA|||Day 10||11.06|-23.08|0.2765
72391690|NCT02795832|144290802|SUPERIORITY|ANCOVA model was fitted with percent change from baseline to Week 2 in EASI score as the dependent variable. Explanatory variables fitted were: treatment group (ZPL-5212372, placebo) and baseline EASI score as a continuous variable.|Mean Difference (Net)|0.05||||0.5016|TWO_SIDED|90.0|-21.24|21.34|||ANCOVA|||Day 15||21.34|-21.24|0.5016
72391691|NCT02795832|144290803|SUPERIORITY|ANCOVA model was fitted with percent change from baseline to Week 2 in EASI score as the dependent variable. Explanatory variables fitted were: treatment group (ZPL-5212372, placebo) and baseline EASI score as a continuous variable.|Odds Ratio (OR)|1.55||||0.4789|TWO_SIDED|90.0|0.28|10.75||The 1-sided p-value tests if the ZPL-5212372 LS mean is \< placebo LS mean.|ANCOVA|||EASI 50||10.75|0.28|0.4789
72391692|NCT02795832|144290803|SUPERIORITY|ANCOVA model was fitted with percent change from baseline to Week 2 in EASI score as the dependent variable. Explanatory variables fitted were: treatment group (ZPL-5212372, placebo) and baseline EASI score as a continuous variable.|Odds Ratio (OR)|2.0||||0.3|TWO_SIDED|90.0|0.24|999.0||The 1-sided p-value tests if the ZPL-5212372 LS mean is \< placebo LS mean.|ANCOVA|||EASI-75||999|0.24|0.3000
72391693|NCT02795832|144290804|SUPERIORITY||Odds Ratio (OR)|0.45||||0.5|TWO_SIDED|95.0|0.01|19.2||Results for the ZPL-5212372 and placebo groups are estimated adjusted LS means from the fitted model.|Shapiro-Wilkes test|The p-value tests if the residuals are normally distributed.||||19.20|0.01|0.500
72391694|NCT02795832|144290805|SUPERIORITY||Mean Difference (Net)|0.07|STANDARD_DEVIATION|1.22||0.5233|TWO_SIDED|90.0|-2.02|2.16|||Shapiro-Wilkes test|||||2.16|-2.02|0.5233
72391695|NCT02795832|144290806|SUPERIORITY||Odds Ratio (OR)|2.43||||0.2455|TWO_SIDED|95.0|0.45|13.26|||t-test, 1 sided|||||13.26|0.45|0.2455
72391696|NCT02795832|144290807|SUPERIORITY||Mean Difference (Net)|-2.66|STANDARD_ERROR_OF_MEAN|4.521||0.2812|TWO_SIDED|90.0|-10.4|5.09||The 1-sided p-value tests if the ZPL-5212372 LS mean is \< placebo LS mean.|Shapiro-Wilkes test|||||5.09|-10.40|0.2812
72391697|NCT04523220|144290811|OTHER||Cox Proportional Hazard|0.59|||=|0.222|TWO_SIDED|90.0|0.28|1.21||Due to the explorative nature of these analyses, no multiplicity adjustment was done.|Log Rank|||Two-sided log-rank tests and Cox proportional hazards model were used in the analyses.||1.21|0.28|= 0.222
72391698|NCT04523220|144290811|OTHER||Cox Proportional Hazard|0.72|||=|0.427|TWO_SIDED|90.0|0.36|1.42||Due to the explorative nature of these analyses, no multiplicity adjustment was done.|Log Rank|||Two-sided log-rank tests and Cox proportional hazards model were used in the analyses.||1.42|0.36|= 0.427
72391699|NCT04523220|144290812|OTHER||Cox Proportional Hazard|1.27|||=|0.128|TWO_SIDED|90.0|0.98|1.64||Due to the explorative nature of these analyses, no multiplicity adjustment was done.|Log Rank|||Two-sided log-rank tests and Cox proportional hazards model were used in the analyses.||1.64|0.98|= 0.128
72391700|NCT04523220|144290812|OTHER||Cox Proportional Hazard|1.24|||=|0.166|TWO_SIDED|90.0|0.96|1.61||Due to the explorative nature of these analyses, no multiplicity adjustment was done.|Log Rank|||Two-sided log-rank tests and Cox proportional hazards model were used in the analyses.||1.61|0.96|= 0.166
72391701|NCT02010775|144290816|OTHER||Least Squares Mean (LS) Mean Difference|-3.88|||<|0.001|TWO_SIDED|95.0|-5.58|-2.19|||ANOVA|ANOVA model with treatment, and baseline MMPS grade as factors.||||-2.19|-5.58|< 0.001
72391702|NCT02010775|144290816|OTHER||LS Mean Difference|-6.32|||<|0.001|TWO_SIDED|95.0|-8.02|-4.62|||ANOVA|ANOVA model with treatment, and baseline MMPS grade as factors.||||-4.62|-8.02|<0.001
72391703|NCT02010775|144290816|OTHER||LS Mean Difference|-6.89|||<|0.001|TWO_SIDED|95.0|-8.56|-5.22|||ANOVA|ANOVA model with treatment, and baseline MMPS grade as factors.||||-5.22|-8.56|<0.001
72391704|NCT02010775|144290816|OTHER||LS Mean Difference|-7.68|||<|0.001|TWO_SIDED|95.0|-9.35|-6.0|||ANOVA|ANOVA model with treatment, and baseline MMPS grade as factors.||||-6.00|-9.35|<0.001
72391705|NCT02010775|144290817|OTHER||Percentage Difference|31.5||||0.008|TWO_SIDED|95.0|9.8|53.3|||Cochran-Mantel-Haenszel|P-values for between-treatment comparisons were determined using Cochran-Mantel-Haenszel (CMH) tests stratified by baseline MMPS.||||53.3|9.8|0.008
72453934|NCT05785832|144431238|SUPERIORITY||Mean Difference (Net)|-0.01|||||TWO_SIDED|95.0|-0.02|0.01||||||||0.01|-0.02|
72453935|NCT05785832|144431239|SUPERIORITY||Mean Difference (Net)|-0.03|||||TWO_SIDED|95.0|-0.07|0.01||||||Adjusted Difference Between Groups||0.01|-0.07|
72453936|NCT05785832|144431240|SUPERIORITY||Mean Difference (Net)|-4.4|||||TWO_SIDED|95.0|-6.0|-2.7||||||Adjusted Difference Between Groups||-2.7|-6.0|
72453937|NCT05785832|144431241|SUPERIORITY||Mean Difference (Net)|-14.0|||||TWO_SIDED|95.0|-18.0|-10.0||||||Adjusted Difference Between Groups||-10|-18|
72453938|NCT05785832|144431242|SUPERIORITY||Mean Difference (Net)|-3.9|||||TWO_SIDED|95.0|-5.2|-2.7||||||Adjusted Difference Between Groups||-2.7|-5.2|
72453939|NCT05785832|144431243|SUPERIORITY||Difference in percent of participants.|16.0|||||TWO_SIDED|95.0|8.0|24.0|||||Estimation represents the difference in percent of participants in each arm who achieved the outcome.|||24|8|
72453940|NCT05785832|144431244|SUPERIORITY||Difference in percent of participants.|26.0|||||TWO_SIDED|95.0|12.0|41.0|||||Estimation represents the difference in percent of participants in each arm who achieved the outcome.|||41|12|
72453941|NCT05785832|144431245|SUPERIORITY||Difference in percent of participants.|34.0|||||TWO_SIDED|95.0|21.0|45.0|||||Estimation represents the difference in percent of participants in each arm who achieved the outcome.|||45|21|
72453942|NCT05785832|144431248|SUPERIORITY||Difference in percent of participants.|15.0|||||TWO_SIDED|95.0|8.0|22.0|||||Estimation represents the difference in percent of participants in each arm who achieved the outcome.|||22|8|
72453943|NCT05785832|144431249|SUPERIORITY||Mean Difference (Net)|-10.0|||||TWO_SIDED|95.0|-20.0|0.0||||||Adjusted Difference Between Groups.||0|-20|
72453944|NCT05785832|144431250|SUPERIORITY||Mean Difference (Net)|-0.5|||||TWO_SIDED|95.0|-4.4|3.4||||||Adjusted Difference Between Groups.||3.4|-4.4|
72453945|NCT05785832|144431251|SUPERIORITY||Median Difference (Net)|1.5|||||TWO_SIDED|95.0|0.5|2.5||||||Adjusted Difference Between Groups.||2.5|0.5|
72453946|NCT05785832|144431252|SUPERIORITY||Mean Difference (Net)|1.1|||||TWO_SIDED|95.0|-2.5|4.7||||||Adjusted Difference Between Groups.||4.7|-2.5|
72453947|NCT05785832|144431253|SUPERIORITY||Mean Difference (Net)|-1.3|||||TWO_SIDED|95.0|-3.4|0.7||||||Adjusted Difference Between Groups.||0.7|-3.4|
72453948|NCT05785832|144431254|SUPERIORITY||Median Difference (Net)|2.1|||||TWO_SIDED|95.0|0.5|3.7||||||Adjusted Difference Between Groups.||3.7|0.5|
72620213|NCT04679818|144771408|SUPERIORITY||Mean Difference (Final Values)|0.08||||0.895|TWO_SIDED|99.0|-1.43|1.58|||Mixed Models Analysis|||||1.58|-1.43|0.895
72453949|NCT05785832|144431255|SUPERIORITY||Mean Difference (Net)|4.9|||||TWO_SIDED|95.0|-1.4|11.1||||||Adjusted Difference Between Groups.||11.1|-1.4|
72453950|NCT05785832|144431256|SUPERIORITY||Mean Difference (Net)|-20.0|||||TWO_SIDED|95.0|-45.0|4.0||||||Adjusted Difference Between Groups.||4|-45|
72453951|NCT03414684|144431264|SUPERIORITY||Hazard Ratio (HR)|0.95||||0.88|TWO_SIDED|95.0|0.49|1.84|||Log Rank|stratified log rank test|Reference level is Arm B, such that hazard ratio corresponds to the effect of treatment on Arm A|||1.84|0.49|0.88
72499612|NCT01431287|144529531|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.059|STANDARD_ERROR_OF_MEAN|0.026||0.0233|TWO_SIDED|95.0|0.008|0.109||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.109|0.008|0.0233
72499613|NCT01431287|144529531|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.012|STANDARD_ERROR_OF_MEAN|0.026||0.6413|TWO_SIDED|95.0|-0.039|0.063||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.063|-0.039|0.6413
72499614|NCT01431287|144529531|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.088|STANDARD_ERROR_OF_MEAN|0.026||0.0007|TWO_SIDED|95.0|0.037|0.138||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.138|0.037|0.0007
72620214|NCT04679818|144771409|SUPERIORITY||Mean Difference (Final Values)|-0.84||||0.228|TWO_SIDED|99.0|-2.66|0.99|||Mixed Models Analysis|||||0.99|-2.66|0.228
72620215|NCT04679818|144771410|SUPERIORITY||Risk Ratio (RR)|0.81||||0.565|TWO_SIDED|95.0|0.4|1.65|||generalized linear mixed effects model|||||1.65|0.40|0.565
72620216|NCT04679818|144771411|SUPERIORITY||Risk Ratio (RR)|1.48||||0.379|TWO_SIDED|95.0|0.62|3.54|||Generalized linear mixed effects model|||||3.54|0.62|0.379
72453952|NCT03414684|144431265|SUPERIORITY||Odds Ratio (OR)|1.09||||1|TWO_SIDED|95.0|0.29|4.18|||Fisher Exact||Reference level is Arm B, such that the odds ratio corresponds to the effect of treatment on Arm A|||4.18|0.29|1
72453953|NCT03414684|144431267|SUPERIORITY||Hazard Ratio (HR)|0.8||||0.49|TWO_SIDED|95.0|0.43|1.5|||Log Rank|stratified log rank test|Reference level is Arm B, such that the hazard ratio corresponds to treatment on Arm A|||1.50|0.43|0.49
72453954|NCT03414684|144431268|SUPERIORITY||Odds Ratio (OR)|1.05||||1|TWO_SIDED|95.0|0.32|3.43|||Fisher Exact||Reference level is Arm B, such that the odds ratio corresponds to treatment on Arm A|||3.43|0.32|1
72453955|NCT03414684|144431269|SUPERIORITY||Hazard Ratio (HR)|0.53||||0.36|TWO_SIDED|95.0|0.13|2.12|||Log Rank||Reference level is Arm B, such that the hazard ratio corresponds to treatment on Arm A|||2.12|0.13|0.36
72453956|NCT03414684|144431270|SUPERIORITY||Hazard Ratio (HR)|1.24||||0.68|TWO_SIDED|95.0|0.43|3.43|||Log Rank||Reference level is Arm B, such that the hazard ratio corresponds to treatment on Arm A|||3.43|0.43|0.68
72453957|NCT03414684|144431271|SUPERIORITY||Hazard Ratio (HR)|0.54||||0.27|TWO_SIDED|95.0|0.18|1.62|||Log Rank|stratified log rank test|Reference level is Arm B, such that the hazard ratio corresponds to treatment on Arm A|||1.62|0.18|0.27
72453958|NCT03414684|144431272|SUPERIORITY||Odds Ratio (OR)|0.81||||1|TWO_SIDED|95.0|0.08|7.78|||Fisher Exact||Reference level is Arm B, such that the odds ratio corresponds to treatment on Arm A|||7.78|0.08|1
72453959|NCT03414684|144431274|SUPERIORITY||Hazard Ratio (HR)|0.75||||0.61|TWO_SIDED|95.0|0.26|2.16|||Log Rank|stratified log rank test|Reference level is Arm B, such that the hazard ratio corresponds to treatment on Arm A|||2.16|0.26|0.61
72453960|NCT03414684|144431275|SUPERIORITY||Odds Ratio (OR)|0.79||||1|TWO_SIDED|95.0|0.1|5.93|||Fisher Exact||Reference level is Arm B, such that the odds ratio corresponds to treatment on Arm A|||5.93|0.10|1
72453961|NCT03414684|144431277|SUPERIORITY||Hazard Ratio (HR)|0.75||||0.73|TWO_SIDED|95.0|0.14|3.89|||Log Rank||Reference level is Arm B, such that the hazard ratio corresponds to treatment on Arm A|||3.89|0.14|0.73
72453962|NCT04038580|144431292|SUPERIORITY|||||||0.553||||||Statistical significance was set a-priori at p\<0.05|ANOVA|||The null hypothesis was that all sockets would have the same SCS||||0.553
72453963|NCT04038580|144431293|SUPERIORITY|Frustration sub-scale||||||0.536|||||||ANOVA|||The null hypothesis was that all sockets would be the same||||0.536
72453964|NCT04038580|144431293|SUPERIORITY|Perceived Response||||||0.598|||||||ANOVA|||||||0.598
72453965|NCT04038580|144431293|SUPERIORITY|Social Burden||||||0.072|||||||ANOVA|||||||0.072
72453966|NCT04038580|144431293|SUPERIORITY|Ambulation Sub-scale||||||0.018|||||||ANOVA|||||||0.018
72453967|NCT04038580|144431293|SUPERIORITY|Prosthesis Utility||||||0.037|||||||ANOVA|||||||0.037
72453968|NCT04038580|144431293|SUPERIORITY|Residual Limb Health||||||0.254|||||||ANOVA|||||||0.254
72453969|NCT04038580|144431293|SUPERIORITY|Appearance||||||0.032|||||||ANOVA|||||||0.032
72453970|NCT04038580|144431293|SUPERIORITY|Sounds||||||0.352|||||||ANOVA|||||||0.352
72453971|NCT04038580|144431293|SUPERIORITY|Well-being||||||0.077|||||||ANOVA|||||||.077
72453972|NCT04038580|144431294|SUPERIORITY|||||||0.95|||||||ANOVA|general linear model with socket as fixed factor and participant as random factor||||||0.95
72620217|NCT04679818|144771412|SUPERIORITY||Median Difference (Final Values)|0.54||||0.039|TWO_SIDED|95.0|0.3|0.97|||Wilcoxon (Mann-Whitney)|||||0.97|0.30|0.039
72453973|NCT04038580|144431295|SUPERIORITY|||||||0.853|||||||ANOVA|general linear model with sockets as fixed effect and subjects as random effect||||||.853
72453974|NCT04038580|144431296|SUPERIORITY|||||||0.565|||||||ANOVA|general linear model with socket as a fixed factor and subjects as a random factor||||||0.565
72453975|NCT04038580|144431298|SUPERIORITY|||||||0.374|||||||ANOVA|general linear model with socket as fixed factor and subjects as random factor||||||.374
72453976|NCT04038580|144431300|SUPERIORITY|||||||0.574|||||||ANOVA|general linear model with socket as a fixed factor and subjects as a random factor||||||.574
72453977|NCT00310180|144431306|SUPERIORITY|Since the noninferiority comparison is formulated using a conventional superiority null hypothesis described as above, a type II error corresponds to concluding that Arm B is not inferior when in fact it is. The design therefore uses a one-sided type I error of 10% and is planned to have 95% power (5% type II error). If the null hypothesis is rejected (at the one-sided 10% level), then it will be concluded that endocrine therapy alone is inferior to chemoendocrine therapy.|Hazard Ratio (HR)|1.08||||0.13|TWO_SIDED|95.0|0.94|1.24||One-sided p value for stratified Cox proportional hazard analysis, stratified on recurrence score, tumor size and menopausal status.|Regression, Cox|||This study uses a noninferiority design, but the noninferiority question is formulated using the conventional superiority null hypothesis of equal DFS on the two arms (that is, the null hypothesis is that Arm B is not inferior to Arm C). The alternative hypothesis is that Arm B has substantially worse DFS than Arm C, specified by a hazard ratio for B vs. C of 1.322.||1.24|0.94|0.13
72453978|NCT00310180|144431310|OTHER|Treatment-by-Age and RS subset was performed via Cox proportional hazard analysis||||||0.004|||||||Regression, Cox|||Treatment interaction test was performed for the 9 age by RS subsets (3 groups for each, age groups \<=50 vs. 51-65 vs. 66-75; RS groups 0-10 vs. 11-25 vs. \>25) in patients randomized to arms B and C||||0.004
72453979|NCT03926026|144431334|SUPERIORITY||Mean Difference (Final Values)|-0.8||||0.0471|TWO_SIDED|95.0|-1.5|0.0|||t-test, 2 sided|||||0|-1.5|0.0471
72453980|NCT00705406|144431373|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.927||||0.222|TWO_SIDED|95.0|0.723|1.188|||Wilcoxon-Gehan test statistic|P-value is from a Wilcoxon-Gehan test statistic controlling for smoking status and hemisphere of enrollment.|Hazard Ratio and corresponding 95% CI are based the Cox Regression Model including parameters for treatment, controlling for smoking status and hemisphere of enrollment.|||1.188|0.723|0.222
72453981|NCT00705406|144431374|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||van Elteren test|P-value for comparisons at all time points. P-value was based on the van Elteren test controlling for smoking status and hemisphere of enrollment.||||||>0.05
72453982|NCT00705406|144431375|SUPERIORITY_OR_OTHER|||||||0.421|TWO_SIDED||||||van Elteren test|P-value is based on van Elteren test controlling for smoking status and hemisphere of enrollment.||||||0.421
72453983|NCT00705406|144431376|SUPERIORITY_OR_OTHER|||||||0.885|TWO_SIDED||||||Wilcoxon-Gehan test statistic|P-values are from a Wilcoxon-Gehan test statistic controlling for smoking status and hemisphere of enrollment.||||||0.885
72453984|NCT00705406|144431377|SUPERIORITY_OR_OTHER|||||||0.306|TWO_SIDED||||||Cochran-Mantel-Haenszel|P-value is based on the Cochran-Mantel-Haenszel general association test controlling for smoking status and hemisphere of enrollment.||||||0.306
72453985|NCT01079806|144431388|SUPERIORITY||Difference estimate|20.2||||0.0049|TWO_SIDED|95.0|9.1|31.4|||Normal approximation||Difference estimate is stratified by age randomization strata, using Cochran-Mantel-Haenszel weighting.|||31.4|9.1|0.0049
72453986|NCT01079806|144431389|SUPERIORITY||Difference estimate|41.8|||<|0.0001|TWO_SIDED|95.0|29.4|54.2|||Normal approximation||Difference estimate is stratified by age randomization strata, using Cochran-Mantel-Haenszel weighting.|||54.2|29.4|<0.0001
72453987|NCT01079806|144431390|SUPERIORITY||Difference estimate|45.2|||<|0.0001||95.0|29.2|61.2|||Normal approximation||Difference estimate is stratified by age randomization strata, using Cochran-Mantel-Haenszel weighting.|||61.2|29.2|<0.0001
72499615|NCT01431287|144529531|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.094|STANDARD_ERROR_OF_MEAN|0.026||0.0003|TWO_SIDED|95.0|0.043|0.144||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.144|0.043|0.0003
72620218|NCT04679818|144771413|NON_INFERIORITY|We tested noninferiority of NOL to routine care on the Ramsey score using an a priori-defined noninferiority delta of 1.2 for the proportional odds ratio; NOL would be deemed noninferior if the upper confidence limit for the odds ratio was \<1.2.|Odds Ratio (OR)|0.8||||0.169|TWO_SIDED|95.0|0.35|1.82|||proportional odds model|||||1.82|0.35|0.169
72620219|NCT04679818|144771414|SUPERIORITY||Hazard Ratio (HR)|1.01||||0.967|TWO_SIDED|95.0|0.63|1.63|||Cox proportional hazards regression|||||1.63|0.63|0.967
72453988|NCT01079806|144431391|SUPERIORITY||Difference estimate|38.2|||<|0.0001|TWO_SIDED|95.0|25.9|50.5|||Normal approximation||Difference estimate is stratified by age randomization strata, using Cochran-Mantel-Haenszel weighting.|||50.5|25.9|<0.0001
72453989|NCT01079806|144431392|SUPERIORITY||Difference estimate|12.1||||0.11|TWO_SIDED|95.0|-1.5|25.7|||Normal approximation||Difference estimate is stratified by age randomization strata, using Cochran-Mantel-Haenszel weighting.|||25.7|-1.5|0.11
72453990|NCT03732807|144431403|SUPERIORITY||Estimate of difference|29.11|||<|1e-06|TWO_SIDED|95.0|21.17|37.91|||Miettinen and Nurminen method|||||37.91|21.17|<0.000001
72453991|NCT03732807|144431403|SUPERIORITY||Estimate of difference|20.78|||<|1e-06|TWO_SIDED|95.0|13.65|29.18|||Miettinen and Nurminen method|||||29.18|13.65|<0.000001
72453992|NCT03732807|144431403|SUPERIORITY||Estimate of difference|21.85|||<|1e-06|TWO_SIDED|95.0|14.65|30.23|||Miettinen and Nurminen method|||||30.23|14.65|<0.000001
72453993|NCT03732807|144431403|SUPERIORITY||Estimate of difference|12.75||||0.000154|TWO_SIDED|95.0|6.69|20.36|||Miettinen and Nurminen method|||||20.36|6.69|0.000154
72453994|NCT03732807|144431404|SUPERIORITY||Estimate of difference|19.75|||<|1e-06|TWO_SIDED|95.0|11.91|27.59|||Miettinen and Nurminen method|||A generalized linear mixed effect model without imputation using observed data up to Week 24 was used as the imputation model. A single complete imputed data set for Week 24 was analyzed using the Miettinen and Nurminen method as the analysis model.||27.59|11.91|<0.000001
72620220|NCT01316900|144771429|SUPERIORITY_OR_OTHER||Least squares mean difference|0.09|||<|0.001|TWO_SIDED|95.0|0.039|0.142|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least squares mean difference=UMEC/VI 62.5/25 µg minus VI 25 µg.|||0.142|0.039|<0.001
72620221|NCT01316900|144771429|SUPERIORITY_OR_OTHER||Least squares mean difference|0.09|||<|0.001|TWO_SIDED|95.0|0.039|0.141||nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least squares mean difference=UMEC/VI 62.5/25 µg minus Tio 18 µg.|||0.141|0.039|<0.001
72620222|NCT01316900|144771429|SUPERIORITY_OR_OTHER||Least squares mean difference|0.088|||<|0.001|TWO_SIDED|95.0|0.036|0.14|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least squares mean difference=UMEC/VI 125/25 µg minus VI 25 µg.|||0.140|0.036|<0.001
72620223|NCT01316900|144771429|SUPERIORITY_OR_OTHER||Least squares mean difference|0.088|||<|0.001|TWO_SIDED|95.0|0.036|0.14|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least squares mean difference=UMEC/VI 125/25 µg minus TIO 18 µg.|||0.140|0.036|<0.001
72620224|NCT00954538|144771439|SUPERIORITY_OR_OTHER||||||<|0.01|||||||t-test, 2 sided|||||||<0.01
72499616|NCT01431287|144529531|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.077|STANDARD_ERROR_OF_MEAN|0.026||0.003|TWO_SIDED|95.0|0.026|0.127||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.127|0.026|0.0030
72499617|NCT01431287|144529531|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.017|STANDARD_ERROR_OF_MEAN|0.026||0.5159|TWO_SIDED|95.0|-0.034|0.068||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.068|-0.034|0.5159
72499618|NCT01431287|144529532|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.21|STANDARD_ERROR_OF_MEAN|0.026|<|0.0001|TWO_SIDED|95.0|0.159|0.261||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.261|0.159|<0.0001
72499619|NCT01431287|144529532|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.089|STANDARD_ERROR_OF_MEAN|0.026||0.0006|TWO_SIDED|95.0|0.038|0.141||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.141|0.038|0.0006
72499620|NCT01431287|144529532|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.183|STANDARD_ERROR_OF_MEAN|0.026|<|0.0001|TWO_SIDED|95.0|0.132|0.234||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.234|0.132|<0.0001
72499621|NCT01431287|144529532|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.068|STANDARD_ERROR_OF_MEAN|0.026||0.0094|TWO_SIDED|95.0|0.017|0.119||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.119|0.017|0.0094
72499622|NCT01431287|144529532|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.062|STANDARD_ERROR_OF_MEAN|0.026||0.0174|TWO_SIDED|95.0|0.011|0.113||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.113|0.011|0.0174
72499623|NCT01431287|144529532|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.028|STANDARD_ERROR_OF_MEAN|0.026||0.2888|TWO_SIDED|95.0|-0.023|0.079||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.079|-0.023|0.2888
72499624|NCT01431287|144529532|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.095|STANDARD_ERROR_OF_MEAN|0.026||0.0003|TWO_SIDED|95.0|0.044|0.146||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.146|0.044|0.0003
72620225|NCT00954538|144771440|SUPERIORITY_OR_OTHER||LS Mean Difference|0.12|||||TWO_SIDED|90.0|-0.04|0.27|||Linear Fixed Effects Model||Difference = AD group value - HE group value|A 90% confidence interval was calculated for the group difference (AD - HE) using the model results. As prespecified by the analysis plan, if the lower bound of the 90% confidence interval is above 0, then the hypothesis that \[18F\]MK-3328 can discriminate between AD patients and cognitively normal elderly controls as measured by regional tracer uptake following single IV doses of \[18F\]MK-3328 is supported.||0.27|-0.04|
72620226|NCT02931539|144771445|SUPERIORITY||Difference in percentage of responders|32.8|||<|0.001|TWO_SIDED|95.0|22.8|42.74|||Cochran-Mantel-Haenszel|||||42.74|22.80|<0.001
72562408|NCT01923311|144656293|EQUIVALENCE|A total of 12 test study participants compared to 334 HIV-infected reference study participants will provide at least 90% power to conclude exposure equivalence of EVG Cmax in test study vs reference study, assuming the expected geometric mean ratio is 1, equivalency boundary is 70% to 143%, 2 one-sided tests are each performed at an alpha level of 0.05, and the standard deviation of EVG Cmax is 0.28 ng•h/mL (natural log scale, estimated from EVG population PK modeling).|GLSM Ratio (%) (Test/Reference)|146.68|||||TWO_SIDED|90.0|127.35|168.94||||||To determine whether the proposed EVG dose in children achieves similar systemic exposure to adults, statistical comparisons were performed with PK data from the current study (test) and adult data from population PK modeling in study GS-US-183-0145 (NCT00708162) (reference).||168.94|127.35|
72562409|NCT00653159|144656317|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4003|||||||Fisher Exact|Two-sided test||Fisher's exact test was used to examine the significance of the association between IUD type (Paragard or Mirena) and whether or not the subject completed the final study visit at 6 months. Under the null hypothesis, study completion rates are similar for both IUD types.||||0.4003
72562410|NCT00653159|144656318|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4136|||||||Fisher Exact|Two-sided test||Fisher's exact test was used to examine the significance of the association between IUD type (Paragard or Mirena) and whether or not the subject experienced heavy bleeding. Under the null hypothesis, heavy bleeding rates are similar for both IUD types.||||0.4136
72620227|NCT02931539|144771446|SUPERIORITY||Difference in percentage of responders|9.5||||0.013|TWO_SIDED|95.0|2.02|16.88|||Cochran-Mantel-Haenszel|||||16.88|2.02|0.013
72620228|NCT02931539|144771461|OTHER||Hazard Ratio (HR)|1.14||||0.647|TWO_SIDED|95.0|0.549|2.357|||Log Rank|Two-sided p-value comparing treatment groups was calculated from the log rank test by Kaplan-Meier Method.|Stratified Cox regression model was used as transplant type and baseline plasma CMV DNA level as stratification factors.|||2.357|0.549|0.647
72391706|NCT02010775|144290817|OTHER||Percentage Difference|48.2|||<|0.001|TWO_SIDED|95.0|28.6|67.8|||Cochran-Mantel-Haenszel|P-values for between-treatment comparisons were determined using CMH tests stratified by baseline MMPS.||||67.8|28.6|< 0.001
72453995|NCT03732807|144431404|SUPERIORITY||Estimate of difference|11.33||||0.000526||95.0|4.93|17.74|||Miettinen and Nurminen method|||A generalized linear mixed effect model without imputation using observed data up to Week 24 was used as the imputation model. A single complete imputed data set for Week 24 was analyzed using the Miettinen and Nurminen method as the analysis model.||17.74|4.93|0.000526
72453996|NCT03732807|144431404|SUPERIORITY||Estimate of difference|11.88||||0.000311||95.0|5.42|18.33|||Miettinen and Nurminen method|||A generalized linear mixed effect model without imputation using observed data up to Week 24 was used as the imputation model. A single complete imputed data set for Week 24 was analyzed using the Miettinen and Nurminen method as the analysis model.||18.33|5.42|0.000311
72562411|NCT00653159|144656319|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4783|||||||Fisher Exact|Two-sided test||Fisher's exact test was used to examine the significance of the association between IUD type (Paragard or Mirena) and whether or not the subject became pregnant within 6 months of IUD insertion. Under the null hypothesis, pregnancy rates are similar for both IUD types.||||0.4783
72562412|NCT00653159|144656320|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2174|||||||Fisher Exact|Two-sided test||Fisher's exact test was used to examine the significance of the association between IUD type (Paragard or Mirena) and whether or not the subject experienced expulsion of the IUD. Under the null hypothesis, expulsion rates are similar for both IUD types.||||0.2174
72620229|NCT02059642|144771471|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-2.1||||0.1358|TWO_SIDED|95.0|-4.87|0.66|||Mixed Models Analysis|MMRM: Model of Repeated Measures||||0.66|-4.87|0.1358
72620230|NCT03061214|144771487|NON_INFERIORITY|Non-inferiority was concluded if the upper limit of the two-sided 95% confidence interval for the estimated difference in HbA1c between semaglutide and sitagliptin was less than 0.3%.|Treatment difference|-0.85|||<|0.0001|TWO_SIDED|95.0|-1.0|-0.7|||Mixed Models Analysis|||The post-baseline responses are analysed using a mixed model for repeated measurements with treatment and region China/Other as fixed factors and baseline value as covariate, all nested within visit. Mean estimates are adjusted according to observed baseline distribution.||-0.70|-1.00|<.0001
72622470|NCT04903093|144774907|OTHER|The ratio and 90% CI were expressed as percentages.|Ratio (%) of adjusted geometric means|96.96|||||TWO_SIDED|90.0|85.43|110.03||||||Test: Abrocitinib 200 mg oral suspension formulation 1; Reference: Abrocitinib 200 mg commercial tablet||110.03|85.43|
72391707|NCT02010775|144290817|OTHER||Percentage Difference|54.3|||<|0.001|TWO_SIDED|95.0|36.1|72.6|||Cochran-Mantel-Haenszel|P-values for between-treatment comparisons were determined using CMH tests stratified by baseline MMPS.||||72.6|36.1|< 0.001
72453997|NCT03732807|144431404|SUPERIORITY||Estimate of difference|9.09||||0.002922||95.0|3.1|15.07|||Miettinen and Nurminen method|||A generalized linear mixed effect model without imputation using observed data up to Week 24 was used as the imputation model. A single complete imputed data set for Week 24 was analyzed using the Miettinen and Nurminen method as the analysis model.||15.07|3.10|0.002922
72453998|NCT03732807|144431405|SUPERIORITY||Estimate of difference|20.24|||<|1e-06||95.0|13.23|28.49|||Miettinen and Nurminen method|||||28.49|13.23|<0.000001
72453999|NCT03732807|144431405|SUPERIORITY||Estimate of difference|11.68||||0.000337||95.0|5.82|19.07|||Miettinen and Nurminen method|||||19.07|5.82|0.000337
72562413|NCT00653159|144656321|SUPERIORITY_OR_OTHER_LEGACY|||||||1|||||||Fisher Exact|Two-sided test||"Fisher's exact test was used to examine the significance of the association between IUD type (Paragard or Mirena) and whether or not the subject reported being satisfied (happy or very happy) at the 6 month study visit. Under the null hypothesis, satisfaction rates are similar for both IUD types."||||1.0000
72454000|NCT03732807|144431405|SUPERIORITY||Estimate of difference|12.17||||0.000228||95.0|6.27|19.53|||Miettinen and Nurminen method|||||19.53|6.27|0.000228
72454001|NCT03732807|144431405|SUPERIORITY||Estimate of difference|9.39||||0.001875|TWO_SIDED|95.0|3.86|16.46|||Miettinen and Nurminen method|||||16.46|3.86|0.001875
72454002|NCT03732807|144431406|SUPERIORITY||Estimate of difference|42.96|||<|1e-06|TWO_SIDED|95.0|31.68|54.25|||Miettinen and Nurminen method|||||54.25|31.68|<0.000001
72454003|NCT03732807|144431406|SUPERIORITY||Estimate of difference|36.18|||<|1e-06|TWO_SIDED|95.0|25.22|47.14|||Miettinen and Nurminen method|||||47.14|25.22|<0.000001
72562414|NCT00109837|144656322|SUPERIORITY_OR_OTHER||Proportion in 1-year CCR|0.36|STANDARD_DEVIATION|0.06|||ONE_SIDED|95.0|0.25|||||||The regimen would be of no further interest if the true 1-year continuous complete remission (CCR) rate was less than 45% (null). Sample size was chosen for an alternative of 65%, power of 92% and type-1 error of 4.6%.|||0.25|
72499625|NCT01431287|144529532|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.121|STANDARD_ERROR_OF_MEAN|0.026|<|0.0001|TWO_SIDED|95.0|0.07|0.172||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.172|0.070|<0.0001
72499626|NCT01431287|144529532|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.115|STANDARD_ERROR_OF_MEAN|0.026|<|0.0001|TWO_SIDED|95.0|0.064|0.166||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.166|0.064|<0.0001
72499627|NCT01431287|144529532|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.006|STANDARD_ERROR_OF_MEAN|0.026||0.8241|TWO_SIDED|95.0|-0.045|0.057||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.057|-0.045|0.8241
72499628|NCT01431287|144529533|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.158|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.108|0.208||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.208|0.108|<0.0001
72499629|NCT01431287|144529533|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.072|STANDARD_ERROR_OF_MEAN|0.025||0.0048|TWO_SIDED|95.0|0.022|0.122||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.122|0.022|0.0048
72499630|NCT01431287|144529533|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.15|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.101|0.2||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.200|0.101|<0.0001
72499631|NCT01431287|144529533|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.103|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.053|0.152||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.152|0.053|<0.0001
72499632|NCT01431287|144529533|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.064|STANDARD_ERROR_OF_MEAN|0.025||0.0116|TWO_SIDED|95.0|0.014|0.113||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.113|0.014|0.0116
72499633|NCT01431287|144529533|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.008|STANDARD_ERROR_OF_MEAN|0.025||0.7577|TWO_SIDED|95.0|-0.042|0.058||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom|spatial power covariance structure for within-patient errors|||0.058|-0.042|0.7577
72499634|NCT01431287|144529533|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.111|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.061|0.16||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.160|0.061|<0.0001
72562415|NCT00381849|144656324|SUPERIORITY_OR_OTHER|||||||0.32||95.0|||||t-test, 1 sided|||Paired t test for supersaturation of CaOx between baseline and after 6 weeks' treatment on placebo.||||0.32
72562416|NCT00381849|144656324|SUPERIORITY_OR_OTHER|||||||0.23||95.0|||||t-test, 1 sided|||Paired t test for supersaturation of CaOx between baseline and after 6 weeks' treatment on cystone.||||0.23
72562417|NCT00381849|144656324|SUPERIORITY_OR_OTHER|||||||0.41||95.0|||||t-test, 1 sided|||Paired t test for supersaturation of CaOx between six weeks' treatment on cystone and 6 weeks' treatment on placebo.||||0.41
72562418|NCT00381849|144656324|SUPERIORITY_OR_OTHER|||||||0.32||95.0|||||t-test, 1 sided|||Paired t test for supersaturation of CaOx between baseline and after 46 weeks' treatment on cystone.||||0.32
72562419|NCT00381849|144656325|SUPERIORITY_OR_OTHER|||||||0.49||95.0|||||t-test, 1 sided|||Paired t test for supersaturation of Brushite between baseline and after 6 weeks' treatment on placebo.||||0.49
72562420|NCT00381849|144656325|SUPERIORITY_OR_OTHER|||||||0.64||95.0|||||t-test, 1 sided|||Paired t test for supersaturation of Brushite between baseline and after 6 weeks' treatment on cystone.||||0.64
72562421|NCT00381849|144656325|SUPERIORITY_OR_OTHER|||||||0.72||95.0|||||t-test, 1 sided|||Paired t test for supersaturation of Brushite between six weeks' treatment on cystone and 6 weeks' treatment on placebo.||||0.72
72562422|NCT00381849|144656325|SUPERIORITY_OR_OTHER|||||||0.84||95.0|||||t-test, 1 sided|||Paired t test for supersaturation of Brushite between baseline and after 46 weeks' treatment on cystone.||||0.84
72562423|NCT00381849|144656328|SUPERIORITY_OR_OTHER|||||||0.69||95.0|||||t-test, 1 sided|||Paired t test for urinary cystine between baseline and after 6 weeks' treatment on placebo.||||0.69
72562424|NCT00381849|144656328|SUPERIORITY_OR_OTHER|||||||0.25||95.0|||||t-test, 1 sided|||Paired t test for urinary cystine between baseline and after 6 weeks' treatment on cystone.||||0.25
72562425|NCT00381849|144656328|SUPERIORITY_OR_OTHER|||||||0.15||95.0|||||t-test, 1 sided|||Paired t test for urinary cystine between six weeks' treatment on cystone and 6 weeks' treatment on placebo.||||0.15
72562426|NCT00381849|144656328|SUPERIORITY_OR_OTHER|||||||0.2||95.0|||||t-test, 1 sided|||Paired t test for urinary cystine between baseline and after 46 weeks' treatment on cystone.||||0.20
72454004|NCT03732807|144431406|SUPERIORITY||Estimate of difference|39.96|||<|1e-06|TWO_SIDED|95.0|28.85|51.06|||Miettinen and Nurminen method|||||51.06|28.85|<0.000001
72454005|NCT03732807|144431406|SUPERIORITY||Estimate of difference|32.72|||<|1e-06|TWO_SIDED|95.0|21.95|43.5|||Miettinen and Nurminen method|||||43.50|21.95|<0.000001
72454006|NCT04200664|144431480|OTHER|Kendall tau b correlation analysis test was performed between the number of cognitive domains affected and the both ears 3-frequency pure tone average (at 0.5/1/2kHz) or both ears 4-frequency pure tone average (at 0.5/1/2/4kHz).|Kendall Tau-b|0.462||||0.176|TWO_SIDED||||||Kendall tau-b|Kendall tau b non-parametric correlation analysis was performed.||||||0.176
72454007|NCT05256797|144431535|SUPERIORITY||Cox Proportional Hazard|0.69|||||TWO_SIDED|95.0|0.66|0.71||||||Hazard ratio||0.71|0.66|
72454008|NCT05325294|144431548|NON_INFERIORITY|The overall mean change in HbA1c from baseline to end of 3-month study period. The mean change will be estimated and compared to a threshold of -0.38% with a margin of 0.4%.|Mean difference from baseline to exit|-0.1||||0.133|TWO_SIDED|95.0|-0.2|0.1|||t-test, 1 sided||This is one arm study, the differences of HbA1c from baseline to exit were summarized for this endpoint|||0.1|-0.2|0.133
72562427|NCT00381849|144656329|SUPERIORITY_OR_OTHER|||||||0.85||95.0|||||t-test, 2 sided|||Right Kidney Stone Density; P-value comparing one year to baseline||||0.85
72562428|NCT00381849|144656329|SUPERIORITY_OR_OTHER|||||||0.63||95.0|||||t-test, 2 sided|||Left Kidney Stone Density; P-value comparing one year to baseline||||0.63
72562429|NCT00381849|144656329|SUPERIORITY_OR_OTHER|||||||0.97||95.0|||||t-test, 2 sided|||Right Kidney Stone Density; P-value comparing one year to baseline||||0.97
72562430|NCT00381849|144656329|SUPERIORITY_OR_OTHER|||||||0.15||95.0|||||t-test, 2 sided|||Left Kidney Stone Density; P-value comparing one year to baseline||||0.15
72562431|NCT00381849|144656330|SUPERIORITY_OR_OTHER|||||||0.81||95.0|||||t-test, 2 sided|||Right Kidney Stone Volume; P-value comparing one year to baseline||||0.81
72620231|NCT03061214|144771487|NON_INFERIORITY|Non-inferiority was concluded if the upper limit of the two-sided 95% confidence interval for the estimated difference in HbA1c between semaglutide and sitagliptin was less than 0.3%.|Treatment difference|-0.51|||<|0.0001|TWO_SIDED|95.0|-0.66|-0.36|||Mixed Models Analysis|||The post-baseline responses are analysed using a mixed model for repeated measurements with treatment and region China/Other as fixed factors and baseline value as covariate, all nested within visit. Mean estimates are adjusted according to observed baseline distribution.||-0.36|-0.66|<.0001
72454009|NCT05325294|144431548|NON_INFERIORITY|The overall mean change in HbA1c from baseline to end of 3-month study period. The mean change will be estimated and compared to a threshold of -0.5% with a margin of 0.4%.|Mean difference from baseline to exit|-0.4|||<|0.001|TWO_SIDED|95.0|-0.6|-0.3|||Wilcoxon (Mann-Whitney)||This is one arm study, the differences of HbA1c from baseline to exit were summarized for this endpoint|||-0.3|-0.6|<0.001
72454010|NCT05325294|144431549|NON_INFERIORITY|The mean % of time in range (TIR 70-180 mg/dL) will be estimated and compared to a threshold of 65.3% with a margin of -7.5% and a significance level of 0.025 (one-sided).|Mean of Final Value|68.6|||<|0.001|TWO_SIDED|95.0|66.6|70.7|||t-test, 1 sided||This is one arm study, the Percent of Time in Range (TIR70-180 mg/dL) from the last 6-7 weeks of 3 month study period was summarized for this endpoint.|||70.7|66.6|<0.001
72454011|NCT05325294|144431549|NON_INFERIORITY|The mean % of time in range (TIR 70-180 mg/dL) will be estimated and compared to a threshold of 73.7% with a margin of -7.5% and a significance level of 0.025 (one-sided).|Mean of Final Value|77.6|||<|0.001|TWO_SIDED|95.0|75.7|79.4|||t-test, 1 sided||This is one arm study, the Percent of Time in Range (TIR70-180 mg/dL) from the last 6-7 weeks of 3 month study period was summarized for this endpoint.|||79.4|75.7|<0.001
72454012|NCT05325294|144431550|NON_INFERIORITY|The mean % of time in hypoglycemia (\< 54 mg/dL) will be estimated and compared to a threshold of 0.71% with a margin of 2% and a significance level of 0.025 (one-sided).|Mean of Final Value|0.4|||<|0.001|TWO_SIDED|95.0|0.3|0.5|||Wilcoxon (Mann-Whitney)||This is one arm study, the Percent of Time in Hypoglycemia (\< 54 mg/dL) from the last 6-7 weeks of 3 month study period was summarized for this endpoint.|||0.5|0.3|<0.001
72562432|NCT00381849|144656330|SUPERIORITY_OR_OTHER|||||||0.78||95.0|||||t-test, 2 sided|||Left Kidney Stone Volume; P-value comparing one year to baseline||||0.78
72562433|NCT00381849|144656330|SUPERIORITY_OR_OTHER|||||||0.96||95.0|||||t-test, 2 sided|||Right Kidney Stone Volume; P-value comparing one year to baseline||||0.96
72562434|NCT00381849|144656330|SUPERIORITY_OR_OTHER|||||||0.13||95.0|||||t-test, 2 sided|||Left Kidney Stone Volume; P-value comparing one year to baseline||||0.13
72562435|NCT02426541|144656334|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.68||||0.3794|TWO_SIDED|95.0|-2.18|5.54|||ANCOVA|Adjusted for sex and baseline||||5.54|-2.18|0.3794
72562436|NCT02426541|144656335|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.32||||0.5317|TWO_SIDED|95.0|-5.6|2.96|||ANCOVA|Adjusted for sex and baseline||||2.96|-5.60|0.5317
72562437|NCT02426541|144656336|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.003||||0.9984|TWO_SIDED|95.0|-3.07|3.07|||ANCOVA|Adjusted for sex and baseline||||3.07|-3.07|0.9984
72562438|NCT00745134|144656339|OTHER|||||||0.33|||||||ANOVA|||||||0.33
72562439|NCT00951093|144656401|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||P value adjusted for multiple comparisons|Friedman´s test|followed by nonparametric pairwise multiple comparisons||||||<0.001
72562440|NCT00951093|144656402|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002||95.0|||||Friedman´s test|followed by nonparametric pairwise multiple comparisons||||||0.002
72562441|NCT00951093|144656403|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||Friedman´s test|||||||< 0.001
72562442|NCT00951093|144656404|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.02||95.0|||||Wilcoxon (Mann-Whitney)|followed by nonparametric pairwise multiple comparisons||||||< 0.020
72562443|NCT00951093|144656405|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||Wilcoxon (Mann-Whitney)|followed by nonparametric pairwise multiple comparisons||||||< 0.001
72562444|NCT00951093|144656406|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001||95.0|||||Wilcoxon (Mann-Whitney)|followed by nonparametric pairwise multiple comparisons||||||0.001
72562445|NCT00951093|144656407|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||Friedman´s test|followed by nonparametric pairwise multiple comparisons||||||< 0.001
72562446|NCT04412057|144656408|SUPERIORITY||Odds Ratio (OR)|2.86||||0.044|TWO_SIDED|90.0|1.04|7.88|||Regression, Logistic|||The sample size provided greater than 80% power to detect a difference of 0.25 in the proportion of subjects alive and free of respiratory failure using a Chi-square exact test at a one-sided significance level of 0.05. This calculation assumed that the proportion alive and free of respiratory failure will be 0.60 in the placebo group and 0.85 in the CERC-002 group.||7.88|1.04|0.0440
72620232|NCT03061214|144771487|SUPERIORITY|Superiority was concluded if the upper limit of the two-sided 95% confidence interval for the estimated difference in HbA1c between semaglutide and sitagliptin was below 0%.|Treatment difference|-0.85|||<|0.0001|TWO_SIDED|95.0|-1.0|-0.7|||Mixed Models Analysis|||The post-baseline responses are analysed using a mixed model for repeated measurements with treatment and region China/Other as fixed factors and baseline value as covariate, all nested within visit. Mean estimates are adjusted according to observed baseline distribution.||-0.70|-1.00|<.0001
72454013|NCT05325294|144431550|NON_INFERIORITY|The mean % of time in hypoglycemia (\< 54 mg/dL) will be estimated and compared to a threshold of 0.86% with a margin of 2% and a significance level of 0.025 (one-sided).|Mean of Final Value|0.2|||<|0.001|TWO_SIDED|95.0|0.2|0.3|||Wilcoxon (Mann-Whitney)||This is one arm study, the Percent of Time in Hypoglycemia (\< 54 mg/dL) from the last 6-7 weeks of 3 month study period was summarized for this endpoint.|||0.3|0.2|<0.001
72454014|NCT05325294|144431551|SUPERIORITY|The mean % of time in range (TIR 70-180 mg/dL) will be estimated and compared to a threshold of 65.3% and a significance level of 0.025 (one-sided).|Mean of Final Value|68.6|||<|0.001|TWO_SIDED|95.0|66.6|70.7|||t-test, 1 sided||This is one arm study, the Percent of Time in Range (TIR70-180 mg/dL) from the last 6-7 weeks of 3 month study period was summarized for this endpoint.|||70.7|66.6|<0.001
72454015|NCT05325294|144431551|SUPERIORITY|The mean % of time in range (TIR 70-180 mg/dL) will be estimated and compared to a threshold of 73.7% and a significance level of 0.025 (one-sided).|Mean of Final Value|77.6|||<|0.001|TWO_SIDED|95.0|75.7|79.4|||t-test, 1 sided||This is one arm study, the Percent of Time in Range (TIR70-180 mg/dL) from the last 6-7 weeks of 3 month study period was summarized for this endpoint.|||79.4|75.7|<0.001
72454016|NCT03147287|144431571|SUPERIORITY||Hazard Ratio (HR)|1.11||||0.62|TWO_SIDED|90.0|0.79|1.55||We reported two-sided p-values corresponding to two-sided α level of 0.10. The test statistic and p-value were taken from the Cox proportional hazards model score test.|Log Rank|The SAP intended stratified tests and models, however one stratum was only 9 patients making implementation of stratification questionable.|We checked the proportional hazards assumption by visually assessing the plot of log( log(survival)) vs log of survival times according to treatment assignment for parallelism. This was done overall and according to stratum.|The primary objective was investigated by comparing the PFS distributions between two treatment arms using a logrank test with one-sided α level of 0.05 (H0: PFS1≤PFS2; HA: PFS1\>PFS2). Hazard ratios were estimated from a Cox PH model (F+P / F, so that HR\<1 indicates reduced hazard of PFS event with F+P), with two sided 90% CIs (Wald) to align with the design and testing.||1.55|0.79|0.62
72454017|NCT03147287|144431572|SUPERIORITY|||||||1||||||P-value is two sided, for hypothesis test with two-sided α=0.10|Fisher Exact|||The objective response was reported with two-sided 90% CI and compared between two treatment arms using a (unstratified) Fisher's exact test;||||1.000
72454018|NCT02824198|144431597|NON_INFERIORITY|The overall non-inferiority of the booster dose was to be demonstrated if the lower limit of the two-sided 95% Confidence Interval (CI) of the Geometric mean of titer ratios (GMTRs) (booster vs post-dose 3) was greater than (\>) 1/2 for each serotype.|Geometric mean of titer ratio|1.34|||||TWO_SIDED|95.0|0.998|1.79||||||Dengue Virus Serotype 1||1.79|0.998|
72454019|NCT02824198|144431597|NON_INFERIORITY|The overall non-inferiority of the booster dose was to be demonstrated if the lower limit of the two-sided 95% CI of the GMTRs (booster vs post-dose 3) was \> 1/2 for each serotype.|Geometric mean of titer ratio|0.603|||||TWO_SIDED|95.0|0.439|0.829||||||Dengue Virus Serotype 2||0.829|0.439|
72454020|NCT02824198|144431597|NON_INFERIORITY|The overall non-inferiority of the booster dose was to be demonstrated if the lower limit of the two-sided 95% CI of the GMTRs (booster vs post-dose 3) was \> 1/2 for each serotype.|Geometric mean of titer ratio|0.979|||||TWO_SIDED|95.0|0.746|1.28||||||Dengue Virus Serotype 3||1.28|0.746|
72454021|NCT02824198|144431597|NON_INFERIORITY|The overall non-inferiority of the booster dose was to be demonstrated if the lower limit of the two-sided 95% CI of the GMTRs (booster vs post-dose 3) was \> 1/2 for each serotype.|Geometric mean of titer ratio|1.27|||||TWO_SIDED|95.0|0.918|1.75||||||Dengue Virus Serotype 4||1.75|0.918|
72454022|NCT01613417|144431610|NON_INFERIORITY_OR_EQUIVALENCE|Power calculation was based on primary endpoint. 185 patients were deemed necessary for the lower limit of the observed 2-sided 95% confidence interval for the difference to exceed -5% with 85% power.|Percentage PH better minus GV better|0.5||||0.8516|TWO_SIDED|95.0|-4.6|5.6||P-value from Wilcoxon signed-rank test|Wilcoxon (Mann-Whitney)||Difference in percentage ProHance better minus percentage Gadovist/Gadavist better (%)|||5.6|-4.6|0.8516
72562447|NCT04412057|144656409|SUPERIORITY||Odds Ratio (OR)|2.0||||0.1762|TWO_SIDED|90.0|0.59|6.82|||Regression, Logistic|||The proportion of subjects alive at Day 28/ET in the CERC-002 group was compared to that in the placebo group using logistic regression methods. The logistic regression model included terms for treatment group. Model based point estimate (i.e., odds ratio \[OR\]), 90% confidence interval \[CI\], and one-sided p-value were reported.||6.82|0.59|0.1762
72562448|NCT02156154|144656410|SUPERIORITY||Median Difference (Final Values)|-0.04||||0.29|TWO_SIDED|95.0|-0.18|0.11||significance criterion of P \< .044.|Wilcoxon (Mann-Whitney)||Difference = IV Acetaminophen - Placebo group|A total of 28 patients (5%) were missing monitoring data (14 patients in each group). Values for these patients were obtained using multivariable imputation with 5 imputation data sets. The imputation regression model included all of the baseline, intraoperative, surgical, and postanesthesia care unit variables and all of the secondary outcomes||0.11|-0.18|0.29
72562449|NCT02156154|144656411|SUPERIORITY||Mean Difference (Final Values)|-0.28||||0.07|TWO_SIDED|99.4|-0.71|0.15||Confidence intervals were adjusted for 8 comparisons using Bonferroni correction (.05/8 = .006), for a significance criterion of P \< .006.|t-test, 2 sided||Confidence intervals were adjusted for 8 comparisons using Bonferroni correction (.05/8 = .006), for a significance criterion of P \< .006.|||0.15|-0.71|0.07
72562450|NCT02156154|144656412|SUPERIORITY||Mean Difference (Final Values)|-0.11||||0.46|TWO_SIDED|99.4|-0.51|0.29||Confidence intervals were adjusted for 8 comparisons using Bonferroni correction (.05/8 = .006), for a significance criterion of P \< .006.|t-test, 2 sided||Confidence intervals were adjusted for 8 comparisons using Bonferroni correction (.05/8 = .006), for a significance criterion of P \< .006.|||0.29|-0.51|0.46
72620233|NCT03061214|144771487|SUPERIORITY|Superiority was concluded if the upper limit of the two-sided 95% confidence interval for the estimated difference in HbA1c between semaglutide and sitagliptin was below 0%.|Treatment difference|-0.51|||<|0.0001|TWO_SIDED|95.0|-0.66|-0.36|||Mixed Models Analysis|||The post-baseline responses are analysed using a mixed model for repeated measurements with treatment and region China/Other as fixed factors and baseline value as covariate, all nested within visit. Mean estimates are adjusted according to observed baseline distribution.||-0.36|-0.66|<.0001
72391708|NCT02010775|144290817|OTHER||Percentage Difference|54.3|||<|0.001|TWO_SIDED|95.0|36.1|72.6|||Cochran-Mantel-Haenszel|P-values for between-treatment comparisons were determined using CMH tests stratified by baseline MMPS.||||72.6|36.1|<0.001
72620234|NCT01866150|144771566|SUPERIORITY_OR_OTHER||Treatment Difference|1.2||||0.8222|TWO_SIDED|95.0|-9.5|12.0|||Pearson's chi-squared|||A two-sided Pearson's chi-squared test was used to assess the treatment difference in the participants who achieved DAS28 remission.||12.0|-9.5|0.8222
72391709|NCT00256750|144290819|NON_INFERIORITY_OR_EQUIVALENCE|A non-inferiority margin of 10% for the co-primary endpoint of participant and graft survival was used. Determination of a margin for non-inferiority based on 'preservation of benefit' is not feasible, given the low rate of patient death and/or graft loss in the first year post-transplantation, and the absence of published, adequately sized, parallel-group trials with which to assess the effect of CsA on patient death and/or graft loss in the setting of MMF/steroids/basiliximab.|Difference in Percent|3.7|||||TWO_SIDED|97.3|-1.1|9.0||||||||9.0|-1.1|
72391710|NCT00256750|144290819|NON_INFERIORITY_OR_EQUIVALENCE|A non-inferiority margin of 10% for the co-primary endpoint of participant and graft survival was used. Determination of a margin for non-inferiority based on 'preservation of benefit' is not feasible, given the low rate of patient death and/or graft loss in the first year post-transplantation, and the absence of published, adequately sized, parallel-group trials with which to assess the effect of CsA on patient death and/or graft loss in the setting of MMF/steroids/basiliximab.|Difference in Percent|2.7|||||TWO_SIDED|97.3|-2.5|8.1|||||If the lower bound of the CI (belatacept-CsA) was \> -10%, then the corresponding belatacept regimen was considered non-inferior to CsA.|||8.1|-2.5|
72391711|NCT00256750|144290820|SUPERIORITY_OR_OTHER||Difference in Percent|-23.7|||<|0.0001|TWO_SIDED|97.3|-33.3|-13.7|||Chi-squared, Corrected|A continuity-corrected Chi-square test at significance level 0.027 was performed for the difference between the belatacept regimen and cyclosporine||||-13.7|-33.3|<.0001
72391712|NCT00256750|144290820|SUPERIORITY_OR_OTHER||Difference in Percent|-22.9|||<|0.0001|TWO_SIDED|97.3|-32.6|-12.9|||Chi-squared, Corrected|A continuity-corrected Chi-square test at significance level 0.027 was performed for the difference between the belatacept regimen and cyclosporine||||-12.9|-32.6|<.0001
72391713|NCT00256750|144290821|NON_INFERIORITY_OR_EQUIVALENCE|A 20% margin for non-inferiority was used and provides 99% power to ascertain that the upper bound of the 97.3% 2-sided confidence intervals for the absolute difference between each belatacept regimen and cyclosporine, assuming the true acute rejection rate by 12 months is 15% for all three regimens|Difference in Percent|10.0|||||TWO_SIDED|97.3|3.3|17.1|||||For 97.3% CI of difference, normal approximation is used if N\>=5 in both arms. Otherwise exact method is used.|||17.1|3.3|
72391714|NCT00256750|144290821|NON_INFERIORITY_OR_EQUIVALENCE|A 20% margin for non-inferiority was used and provides 99% power to ascertain that the upper bound of the 97.3% 2-sided confidence intervals for the absolute difference between each belatacept regimen and cyclosporine, assuming the true acute rejection rate by 12 months is 15% for all three regimens. The 20% non-inferiority margin was not met in the belatacept MI group.|Difference in Percent|14.7|||||TWO_SIDED|97.3|7.5|22.2|||||For 97.3% CI of difference, normal approximation is used if N\>=5 in both arms. Otherwise exact method is used.|||22.2|7.5|
72391715|NCT00256750|144290822|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.0|||<|0.0001|TWO_SIDED|97.3|7.3|18.7||To account for missing measured GFR due to graft loss or death, an ANOVA model on the ranks of measured GFR (with imputed missing values) at Months 12 with factor for randomization group was applied. Measured GFR missing were assigned the worst rank.|Kruskal-Wallis|Tests comparing a belatacept to CsA were based on the Kruskal-Wallis test (using a chi-square approximation of the distribution of the test statistic)|Test were conducted at a level of 0.027 (2-sided).|Time Frame = Day 1 to Month 12||18.7|7.3|<0.0001
72391716|NCT00256750|144290822|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.6|||<|0.0001|TWO_SIDED|97.3|8.9|20.4||To account for missing measured GFR due to graft loss or death, an ANOVA model on the ranks of measured GFR (with imputed missing values) at Months 12 with factor for randomization group was applied. Measured GFR missing were assigned the worst rank.|Kruskal-Wallis|Tests comparing a belatacept to CsA were based on the Kruskal-Wallis test (using a chi-square approximation of the distribution of the test statistic)|Test were conducted at a level of 0.027 (2-sided).|Time Frame = Day 1 to Month 12||20.4|8.9|<0.0001
72391717|NCT00256750|144290822|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|17.4|||<|0.0001|TWO_SIDED|97.3|11.5|23.4||To account for missing measured GFR due to graft loss or death, an ANOVA model on the ranks of measured GFR (with imputed missing values) at Months 24 with factor for randomization group was applied. Measured GFR missing were assigned the worst rank.|Kruskal-Wallis|Tests comparing a belatacept to CsA were based on the Kruskal-Wallis test (using a chi-square approximation of the distribution of the test statistic)|Test were conducted at a level of 0.027 (2-sided).|Time Frame = Day 1 to Month 24||23.4|11.5|<0.0001
72562451|NCT02156154|144656413|SUPERIORITY||Mean Difference (Final Values)|0.13||||0.56|TWO_SIDED|99.4|-0.49|0.76||Confidence intervals were adjusted for 8 comparisons using Bonferroni correction (.05/8 = .006), for a significance criterion of P \< .006.|t-test, 2 sided||Treatment effect data are reported as differences in means between the study groups, assessed using a 2-sample t test.|||0.76|-0.49|0.56
72562452|NCT02156154|144656414|SUPERIORITY||Mean Difference (Net)|-0.08||||0.3|TWO_SIDED|99.4|-0.29|0.13||Confidence intervals were adjusted for 8 comparisons using Bonferroni correction (.05/8 = .006), for a significance criterion of P \< .006.|t-test, 2 sided||Treatment effect data are reported as differences in means between the study groups, assessed using a 2-sample t test.|||0.13|-0.29|0.30
72562453|NCT02156154|144656415|SUPERIORITY||Ratios of geometric means|0.94||||0.65|TWO_SIDED|99.4|0.63|1.39||Confidence intervals were adjusted for 8 comparisons using Bonferroni correction (.05/8 = .006), for a significance criterion of P \< .006.|t-test, 2 sided||Treatment effect data are reported as ratios of geometric means, assessed using a 2-sample t test after logarithmic transformation of outcomes.|||1.39|0.63|0.65
72454023|NCT01613417|144431610|NON_INFERIORITY_OR_EQUIVALENCE|Power calculation was based on primary endpoint. 185 patients were deemed necessary for the lower limit of the observed 2-sided 95% confidence interval for the difference to exceed -5% with 85% power.|Percentage PH better minus GV better|0.0||||1|TWO_SIDED|95.0|-3.8|3.8||P-value from Wilcoxon signed-rank test|Wilcoxon (Mann-Whitney)||Difference in percentage ProHance better minus percentage Gadovist/Gadavist better (%)|||3.8|-3.8|1.0
72620235|NCT01866150|144771567|SUPERIORITY_OR_OTHER||Treatment Difference|3.7||||0.4727|TWO_SIDED|95.0|-6.2|13.6|||Pearson's chi-squared|||Comparison at Month 3. A two-sided Pearson's chi-squared test was used to assess the treatment difference in the participants who achieved DAS28 remission.||13.6|-6.2|0.4727
72620236|NCT01866150|144771567|SUPERIORITY_OR_OTHER||Treatment Difference|2.6||||0.6349|TWO_SIDED|95.0|-8.0|13.1|||Pearson's chi-squared|||Comparison at last visit. A two-sided Pearson's chi-squared test was used to assess the treatment difference in the participants who achieved DAS28 remission.||13.1|-8.0|0.6349
72620237|NCT01866150|144771568|SUPERIORITY_OR_OTHER||Slope|-0.9||||0.8769|TWO_SIDED|95.0|-12.1|10.4|||Pearson's chi-squared|||Comparison at Month 3. A two-sided Pearson's chi-squared test was used to assess the treatment difference in the participants who achieved LDA.||10.4|-12.1|0.8769
72620238|NCT01866150|144771568|SUPERIORITY_OR_OTHER||Treatment Difference|3.4||||0.5649|TWO_SIDED|95.0|-8.2|15.0|||Pearson's chi-squared|||Comparison at Month 6. A two-sided Pearson's chi-squared test was used to assess the treatment difference in the participants who achieved LDA.||15.0|-8.2|0.5649
72620239|NCT01866150|144771568|SUPERIORITY_OR_OTHER||Treatment Difference|9.9||||0.0556|TWO_SIDED|95.0|-0.3|20.2|||Pearson's chi-squared|||Comparison at the last visit. A two-sided Pearson's chi-squared test was used to assess the treatment difference in the participants who achieved LDA.||20.2|-0.3|0.0556
72620240|NCT01866150|144771569|SUPERIORITY_OR_OTHER||Treatment Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.152||0.5195|TWO_SIDED|95.0|-0.4|0.2|||Mixed Models Analysis|||Comparison at Month 3. Analysis used a mixed model with month, cohort, baseline DAS28 score; cohort-by-month and cohort-by-baseline DAS28 score as fixed effects. Within-participant repeated measurements were incorporated with an unstructured variance-covariance structure.||0.20|-0.40|0.5195
72620241|NCT01866150|144771569|SUPERIORITY_OR_OTHER||Treatment difference|-0.17|STANDARD_ERROR_OF_MEAN|0.149||0.242|TWO_SIDED|95.0|-0.47|0.12|||Mixed Models Analysis|||Comparison at Month 6. Analysis used a mixed model with month, cohort, baseline DAS28 score; cohort-by-month and cohort-by-baseline DAS28 score as fixed effects. Within-participant repeated measurements were incorporated with an unstructured variance-covariance structure.||0.12|-0.47|0.2420
72622471|NCT04903093|144774907|OTHER|The ratio and 90% confidence interval were expressed as percentages.|Ratio (%) of adjusted geometric means|62.87|||||TWO_SIDED|90.0|54.85|72.07||||||Test: Famotidine 40 mg tablet + Abrocitinib 200 mg commecial tablet; Reference: Abrocitinib 200 mg commercial tablet||72.07|54.85|
72454024|NCT01613417|144431610|NON_INFERIORITY_OR_EQUIVALENCE|Power calculation was based on primary endpoint. 185 patients were deemed necessary for the lower limit of the observed 2-sided 95% confidence interval for the difference to exceed -5% with 85% power.|Percentage PH better minus GV better|0.5||||1|TWO_SIDED|95.0|-0.5|1.5||P-value from Wilcoxon signed-rank test|Wilcoxon (Mann-Whitney)||Difference in percentage ProHance better minus percentage Gadovist/Gadavist better (%)|||1.5|-0.5|1.0
72454025|NCT01613417|144431611|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED|||||P-value from Wilcoxon signed-rank test|Wilcoxon (Mann-Whitney)|||||||1.0
72454026|NCT01613417|144431611|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED|||||P-value from Wilcoxon signed-rank test|Wilcoxon (Mann-Whitney)|||||||1.0
72454027|NCT01613417|144431611|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED|||||P-value from Wilcoxon signed-rank test|Wilcoxon (Mann-Whitney)|||||||1.0
72454028|NCT01613417|144431612|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED|||||P-value from Wilcoxon signed-rank test|Wilcoxon (Mann-Whitney)|||||||1.0
72454029|NCT01613417|144431612|SUPERIORITY_OR_OTHER|||||||0.6875|TWO_SIDED|||||P-value from Wilcoxon signed-rank test|Wilcoxon (Mann-Whitney)|||||||0.6875
72454030|NCT01613417|144431612|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED|||||P-value from Wilcoxon signed-rank test|Wilcoxon (Mann-Whitney)|||||||1.0
72454031|NCT01613417|144431613|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED|||||P-value from Wilcoxon signed-rank test|Wilcoxon (Mann-Whitney)|||||||1.0
72454032|NCT01613417|144431613|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED|||||P-value from Wilcoxon signed-rank test|Wilcoxon (Mann-Whitney)|||||||1.0
72454033|NCT01613417|144431613|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED|||||P-value from Wilcoxon signed-rank test|Wilcoxon (Mann-Whitney)|||||||1.0
72454034|NCT01613417|144431614|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED|||||P-value from Wilcoxon signed-rank test|Wilcoxon (Mann-Whitney)|||||||1.0
72454035|NCT01613417|144431614|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED|||||P-value from Wilcoxon signed-rank test|Wilcoxon (Mann-Whitney)|||||||1.0
72562454|NCT02156154|144656416|SUPERIORITY||Ratios of geometric means|0.86||||0.22|TWO_SIDED|99.4|0.61|1.21|||t-test, 2 sided||Treatment effect data are reported as ratios of geometric means, assessed using a 2-sample t test after logarithmic transformation of outcomes.|||1.21|0.61|0.22
72454036|NCT01613417|144431614|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED|||||P-value from Wilcoxon signed-rank test|Wilcoxon (Mann-Whitney)|||||||1.0
72454037|NCT01613417|144431615|SUPERIORITY_OR_OTHER|||||||0.2758|TWO_SIDED||||||Mixed Models Analysis|Mixed effect model with period, sequence, and IP and fixed effect and subject nested within sequence as random effect||||||0.2758
72454038|NCT01613417|144431615|SUPERIORITY_OR_OTHER|||||||0.0676|TWO_SIDED||||||Mixed Models Analysis|Mixed effect model with period, sequence, and IP and fixed effect and subject nested within sequence as random effect||||||0.0676
72454039|NCT01613417|144431615|SUPERIORITY_OR_OTHER|||||||0.5267|TWO_SIDED||||||Mixed Models Analysis|Mixed effect model with period, sequence, and IP and fixed effect and subject nested within sequence as random effect||||||0.5267
72562455|NCT02156154|144656417|SUPERIORITY||Risk Ratio (RR)|1.13||||0.18|TWO_SIDED|99.4|0.88|1.45||Confidence intervals were adjusted for 8 comparisons using Bonferroni correction (.05/8 = .006), for a significance criterion of P \< .006.|Chi-squared||Risk ratio = Treatment/Placebo|||1.45|0.88|0.18
72454040|NCT01613417|144431616|SUPERIORITY_OR_OTHER|||||||0.6201|TWO_SIDED||||||Mixed Models Analysis|Investigation product (IP) effect from mixed model with period, sequence, and IP as fixed effects and subject nested within sequence as random effect.||||||0.6201
72454041|NCT01613417|144431616|SUPERIORITY_OR_OTHER|||||||0.4514|TWO_SIDED||||||Mixed Models Analysis|Investigation product (IP) effect from mixed model with period, sequence, and IP as fixed effects and subject nested within sequence as random effect.||||||0.4514
72454042|NCT01613417|144431616|SUPERIORITY_OR_OTHER|||||||0.7722|TWO_SIDED||||||Mixed Models Analysis|Investigation product (IP) effect from mixed model with period, sequence, and IP as fixed effects and subject nested within sequence as random effect.||||||0.7722
72454043|NCT01613417|144431617|SUPERIORITY_OR_OTHER|||||||0.3173|TWO_SIDED||||||McNemar|||||||0.3173
72454044|NCT01613417|144431617|SUPERIORITY_OR_OTHER|||||||0.5637|TWO_SIDED||||||McNemar|||||||0.5637
72454045|NCT01613417|144431617|SUPERIORITY_OR_OTHER|||||||0.0455|TWO_SIDED||||||McNemar|||||||0.0455
72454046|NCT01613417|144431618|SUPERIORITY_OR_OTHER|||||||0.6949|TWO_SIDED||||||McNemar|||McNemar test of difference (ProHance minus Gadovist/Gadavist) in accuracy for tumor characterization||||0.6949
72454047|NCT01613417|144431618|SUPERIORITY_OR_OTHER|||||||0.1317|TWO_SIDED||||||McNemar|||McNemar test of difference (ProHance minus Gadovist/Gadavist) in accuracy for tumor characterization||||0.1317
72454048|NCT01613417|144431618|SUPERIORITY_OR_OTHER|||||||0.0124|TWO_SIDED||||||McNemar|||McNemar test of difference (ProHance minus Gadovist/Gadavist) in accuracy for tumor characterization||||0.0124
72454049|NCT00790699|144431633|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|||||||RM-ANOVA|||The results were evaluated to determine if any statistically significant changes in any of these measures between the first and final visit occurred and if these changes were associated with membership in the treatment or control group.||||>.05
72454050|NCT00734578|144431689|SUPERIORITY_OR_OTHER_LEGACY||Placebo-adjusted difference in LS mean|-4.5||||0.002||95.0|-7.5|-1.4||Both SPD503 groups were compared with placebo using Dunnett's adjustment. Each treatment comparison was evaluated at the 0.05 significance level (Dunnett's adjusted).|ANCOVA|||The null hypothesis stated that there was no difference between SPD503 AM or placebo and that there was no difference between SPD503 PM or placebo. 90% power was needed to detect an effect size of at least 0.4 between either SPD503 group and placebo.||-1.4|-7.5|0.002
72454051|NCT00734578|144431689|SUPERIORITY_OR_OTHER_LEGACY||Placebo-adjusted difference in LS mean|-5.3|||<|0.001||95.0|-8.3|-2.3||Both SPD503 groups were compared with placebo using Dunnett's adjustment. Each treatment comparison was evaluated at the 0.05 significance level (Dunnett's adjusted).|ANCOVA|||The null hypothesis stated that there was no difference between SPD503 AM or placebo and that there was no difference between SPD503 PM or placebo. 90% power was needed to detect an effect size of at least 0.4 between either SPD503 group and placebo.||-2.3|-8.3|<0.001
72454052|NCT00734578|144431690|SUPERIORITY_OR_OTHER_LEGACY|||||||0.024||95.0||||No adjustments for multiple comparisons.|Cochran-Mantel-Haenszel|||Not powered for secondary outcome measures.||||0.024
72454053|NCT00734578|144431690|SUPERIORITY_OR_OTHER_LEGACY|||||||0.003||95.0||||No adjustments for multiple comparisons.|Cochran-Mantel-Haenszel|||Not powered for secondary outcome measures.||||0.003
72454054|NCT00734578|144431691|SUPERIORITY_OR_OTHER_LEGACY|||||||0.013||95.0||||No adjustments for multiple comparisons.|Cochran-Mantel-Haenszel|||Not powered for secondary outcome measures.||||0.013
72499635|NCT01431287|144529533|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.086|STANDARD_ERROR_OF_MEAN|0.025||0.0007|TWO_SIDED|95.0|0.037|0.136||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.136|0.037|0.0007
72562456|NCT02156154|144656418|SUPERIORITY||Risk Ratio (RR)|0.9||||0.53|TWO_SIDED|99.4|0.57|1.43||Confidence intervals were adjusted for 8 comparisons using Bonferroni correction (.05/8 = .006), for a significance criterion of P \< .006.|Chi-squared||RR = Treatment/Placebo|||1.43|0.57|0.53
72562457|NCT02156154|144656419|SUPERIORITY||Median Difference (Final Values)|0.0||||0.99|TWO_SIDED|99.4|-0.39|0.36||Adjusted for 8 comparisons using Bonferroni correction (.05/8 = .006), for a significance criterion of P \< .006.|Wilcoxon (Mann-Whitney)||Treatment effect is reported as median difference, estimated using the Hodges-Lehmann estimator of location shift.|||0.36|-0.39|0.99
72562458|NCT03449199|144656434|SUPERIORITY||LS Mean Difference|-0.05||||0.7953|TWO_SIDED|95.0|-0.44|0.34|||ANCOVA|||Change from baseline in log-transformed UACR was analyzed using an ANCOVA model with randomized treatment, and randomization strata of sUA and UACR as independent variables. The last observation carried forward imputation was used for missing data. In this study, multiplicity was not considered since the study objective is exploratory.||0.34|-0.44|0.7953
72562459|NCT03449199|144656434|SUPERIORITY||LS Mean Difference|-0.43||||0.0311|TWO_SIDED|95.0|-0.82|-0.04|||ANCOVA|||Change from baseline in log-transformed UACR was analyzed using an ANCOVA model with randomized treatment, and randomization strata of sUA and UACR as independent variables. The last observation carried forward imputation was used for missing data. In this study, multiplicity was not considered since the study objective is exploratory.||-0.04|-0.82|0.0311
72562460|NCT03449199|144656435|SUPERIORITY||LS Mean Difference|1.71||||0.4055|TWO_SIDED|95.0|-2.35|5.78|||ANCOVA|||For Week 12 (visit of the primary outcome), ANCOVA model with treatment, randomization strata of sUA and UACR levels as independent variables, Baseline eGFR as covariate is fitted. The last observation carried forward imputation was used for missing data.||5.78|-2.35|0.4055
72562461|NCT03449199|144656435|SUPERIORITY||LS Mean Difference|3.42||||0.096|TWO_SIDED|95.0|-0.62|7.46|||ANCOVA|||For Week 12 (visit of the primary outcome), an ANCOVA model with treatment, randomization strata of sUA and UACR levels as independent variables, Baseline eGFR as covariate is fitted. The last observation carried forward imputation was used for missing data.||7.46|-0.62|0.0960
72562462|NCT03449199|144656436|SUPERIORITY||LS Mean Difference|-2.43|||<|0.0001|TWO_SIDED|95.0|-3.13|-1.74|||ANCOVA|||For Week 12 (visit of the primary outcome), an ANCOVA model with treatment, randomization strata of UACR levels as independent variables is fitted. The last observation carried forward imputation was used for missing data.||-1.74|-3.13|<0.0001
72562463|NCT03449199|144656436|SUPERIORITY||LS Mean Difference|-3.23|||<|0.0001|TWO_SIDED|95.0|-3.91|-2.54|||ANCOVA|||For Week 12 (visit of the primary outcome), an ANCOVA model with treatment, randomization strata of UACR levels as independent variables is fitted. The last observation carried forward imputation was used for missing data.||-2.54|-3.91|<0.0001
72454055|NCT00734578|144431691|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||No adjustments for multiple comparisons.|Cochran-Mantel-Haenszel|||Not powered for secondary outcome measures.||||<0.001
72454056|NCT00734578|144431692|SUPERIORITY_OR_OTHER_LEGACY||Placebo-adjusted difference in LS mean|-1.7||||0.019||95.0|-3.2|-0.3||No adjustments for multiple comparisons.|ANCOVA|||Not powered for secondary outcome measures.||-0.3|-3.2|0.019
72454057|NCT00734578|144431692|SUPERIORITY_OR_OTHER_LEGACY||Placebo-adjusted difference in LS mean|-2.6|||<|0.001||95.0|-4.0|-1.1||No adjustments for multiple comparisons.|ANCOVA|||Not powered for secondary outcome measures.||-1.1|-4.0|<0.001
72454058|NCT00734578|144431693|SUPERIORITY_OR_OTHER_LEGACY||Placebo-adjusted difference in LS mean|-2.4||||0.002||95.0|-4.0|-0.9||No adjustments for multiple comparisons.|ANCOVA|||Not powered for secondary outcome measures.||-0.9|-4.0|0.002
72454059|NCT00734578|144431693|SUPERIORITY_OR_OTHER_LEGACY||Placebo-adjusted difference in LS mean|-3.0|||<|0.001||95.0|-4.5|-1.5||No adjustments for multiple comparisons.|ANCOVA|||Not powered for secondary outcome measures.||-1.5|-4.5|<0.001
72454060|NCT00734578|144431694|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||No adjustments for multiple comparisons.|Cochran-Mantel-Haenszel|||Not powered for secondary outcome measures.||||<0.001
72454061|NCT00734578|144431694|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||No adjustments for multiple comparisons.|Cochran-Mantel-Haenszel|||Not powered for secondary outcome measures.||||<0.001
72454062|NCT00734578|144431695|SUPERIORITY_OR_OTHER_LEGACY||Placebo-adjusted difference in LS mean|-2.4||||0.001||95.0|-3.9|-0.9||No adjustments for multiple comparisons.|ANCOVA|||Not powered for secondary outcome measures.||-0.9|-3.9|0.001
72454063|NCT00734578|144431695|SUPERIORITY_OR_OTHER_LEGACY||Placebo-adjusted difference in LS mean|-2.2||||0.003||95.0|-3.6|-0.7||No adjustments for multiple comparisons.|ANCOVA|||Not powered for secondary outcome measures.||-0.7|-3.6|0.003
72454064|NCT00734578|144431696|SUPERIORITY_OR_OTHER_LEGACY||Placebo-adjusted difference in LS mean|-5.1|||<|0.001||95.0|-8.0|-2.2||No adjustments for multiple comparisons.|ANCOVA|||Not powered for secondary outcome measures.||-2.2|-8.0|<0.001
72454065|NCT00734578|144431696|SUPERIORITY_OR_OTHER_LEGACY||Placebo-adjusted difference in LS mean|-4.7||||0.002||95.0|-7.6|-1.7||No adjustments for multiple comparisons.|ANCOVA|||Not powered for secondary outcome measures.||-1.7|-7.6|0.002
72454066|NCT00734578|144431697|SUPERIORITY_OR_OTHER_LEGACY|||||||0.971||95.0||||No adjustments for multiple comparisons.|Cochran-Mantel-Haenszel|||Not powered for secondary outcome measures.||||0.971
72620242|NCT01866150|144771569|SUPERIORITY_OR_OTHER||Treatment difference|-0.15|STANDARD_ERROR_OF_MEAN|0.154||0.3264|TWO_SIDED|95.0|-0.45|0.15|||Mixed Models Analysis|||Comparison at the last visit. Analysis used a mixed model with month, cohort, baseline DAS28 score; cohort-by-month and cohort-by-baseline DAS28 score as fixed effects. Within-participant repeated measurements were incorporated with an unstructured variance-covariance structure.||0.15|-0.45|0.3264
72454067|NCT00734578|144431697|SUPERIORITY_OR_OTHER_LEGACY|||||||0.502||95.0||||No adjustments for multiple comparisons.|Cochran-Mantel-Haenszel|||Not powered for secondary outcome measures.||||0.502
72454068|NCT04652726|144431716|SUPERIORITY||LS Mean|-28.54|||<|0.0001|TWO_SIDED|95.0|-35.81|-21.27|||ANCOVA|||||-21.27|-35.81|<.0001
72454069|NCT04652726|144431717|SUPERIORITY||LS Mean|-29.3|||<|0.0001|TWO_SIDED|95.0|-36.24|-22.36|||MMRM|||||-22.36|-36.24|<.0001
72454070|NCT04652726|144431718|SUPERIORITY||LS Mean|-49.99|||<|0.0001|TWO_SIDED|95.0|-63.18|-36.81|||ANCOVA|||||-36.81|-63.18|<.0001
72454071|NCT04652726|144431719|SUPERIORITY||LS Mean|-25.7|||<|0.0001|TWO_SIDED|95.0|-31.68|-19.73|||ANCOVA|||||-19.73|-31.68|<.0001
72454072|NCT04652726|144431720|SUPERIORITY||LS Mean|-6.18||||0.1419|TWO_SIDED|95.0|-17.48|5.12|||ANCOVA|||||5.12|-17.48|0.1419
72454073|NCT04652726|144431721|SUPERIORITY||LS Mean|-26.8|||<|0.0001|TWO_SIDED|95.0|-33.63|-19.97|||ANCOVA|||||-19.97|-33.63|<.0001
72454074|NCT04652726|144431722|SUPERIORITY||LS Mean|-19.2|||<|0.0001|TWO_SIDED|95.0|-24.65|-13.75|||ANCOVA|||||-13.75|-24.65|<.0001
72454075|NCT03274076|144431759|SUPERIORITY||Rate ratio|1.25|||||TWO_SIDED|90.0|0.19|8.33|||||Tofacitinib represents the numerator, and placebo represents the denominator.|H0: Rate of grade 3 (severe) or higher adverse events that occur throughout week 48 in Placebo = Rate of grade 3 (severe) or higher adverse events that occur throughout week 48 in Tofacitinib.||8.33|0.19|
72454076|NCT03274076|144431760|SUPERIORITY||Rate ratio|0.65|||||TWO_SIDED|90.0|0.25|1.71|||||Tofacitinib represents the numerator, and Placebo represents the denominator.|H0: Rate of grade 2 (moderate) or higher adverse events that occur throughout week 12 in Placebo = Rate of grade 2 (moderate) or higher adverse events that occur throughout week 12 in Tofacitinib||1.71|0.25|
72454077|NCT03274076|144431760|SUPERIORITY||Rate ratio|0.53|||||TWO_SIDED|90.0|0.26|1.07|||||Tofacitinib represents the numerator, and Placebo represents the denominator.|H0: Rate of grade 2 (moderate) or higher adverse events that occur throughout week 24 in Placebo = Rate of grade 2 (moderate) or higher adverse events that occur throughout week 24 in Tofacitinib||1.07|0.26|
72454078|NCT03274076|144431760|SUPERIORITY||Rate ratio|0.85|||||TWO_SIDED|90.0|0.49|1.49|||||Tofacitinib represents the numerator, and Placebo represents the denominator.|H0: Rate of grade 2 (moderate) or higher adverse events that occur throughout week 36 in Placebo = Rate of grade 2 (moderate) or higher adverse events that occur throughout week 36 in Tofacitinib||1.49|0.49|
72454079|NCT03274076|144431760|SUPERIORITY||Rate ratio|0.89|||||TWO_SIDED|90.0|0.52|1.52|||||Tofacitinib represents the numerator, and Placebo represents the denominator.|H0: Rate of grade 2 (moderate) or higher adverse events that occur throughout week 48 in Placebo = Rate of grade 2 (moderate) or higher adverse events that occur throughout week 48 in Tofacitinib||1.52|0.52|
72454080|NCT03274076|144431761|SUPERIORITY||Rate ratio|3.85|||||TWO_SIDED|90.0|0.68|21.77|||||Tofacitinib represents the numerator, and Placebo represents the denominator.|H0: Rate of adverse events of special interest throughout week 36 in Placebo = Rate of adverse events of special interest throughout week 36 in Tofacitinib||21.77|0.68|
72454081|NCT03274076|144431761|SUPERIORITY||Rate ratio|1.87|||||TWO_SIDED|90.0|0.5169|6.7652|||||Tofacitinib represents the numerator, and Placebo represents the denominator.|H0: Rate of adverse events of special interest throughout week 48 in Placebo = Rate of adverse events of special interest throughout week 48 in Tofacitinib||6.7652|0.5169|
72454082|NCT03274076|144431762|SUPERIORITY|||||||0.1978|||||||Exact Wilcoxon|||H0: The absolute change in mRSS from week 0 to week 12 in placebo = The absolute change in mRSS from week 0 to week 12 in Tofacitinib.||||0.1978
72454083|NCT03274076|144431762|SUPERIORITY|||||||0.4665|||||||Exact Wilcoxon|||H0: The absolute change in mRSS from week 0 to week 24 in placebo = The absolute change in mRSS from week 0 to week 24 in Tofacitinib.||||0.4665
72562464|NCT03449199|144656437|SUPERIORITY||LS Mean Difference|-102.02||||0.3955|TWO_SIDED|95.0|-338.81|134.78|||ANCOVA|||For Week 12 (visit of the primary outcome), an ANCOVA model with treatment, randomization strata of UACR levels as independent variables is fitted. The last observation carried forward imputation was used for missing data.||134.78|-338.81|0.3955
72562465|NCT03449199|144656437|SUPERIORITY||LS Mean Difference|-197.49||||0.0991|TWO_SIDED|95.0|-432.73|37.75|||ANCOVA|||For Week 12 (visit of the primary outcome), ANCOVA model with treatment, randomization strata of UACR levels as independent variables is fitted. The last observation carried forward imputation was used for missing data.||37.75|-432.73|0.0991
72620243|NCT01866150|144771571|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.81||||0.0237|TWO_SIDED|95.0|-16.44|-1.18|||General Linear Model|||Analysis was performed using a general linear model with cohort as a factor.||-1.18|-16.44|0.0237
72622472|NCT04903093|144774908|OTHER|The ratio and 90% CI were expressed as percentages.|Ratio (%) of adjusted geometric means|100.07|||||TWO_SIDED|90.0|80.28|124.74||||||Test: Abrocitinib 200 mg oral suspension formulation 1; Reference: Abrocitinib 200 mg commercial tablet||124.74|80.28|
72454084|NCT03274076|144431762|SUPERIORITY|||||||0.3063|||||||Exact Wilcoxon|||H0: The absolute change in mRSS from week 0 to week 36 in placebo = The absolute change in mRSS from week 0 to week 36 in Tofacitinib.||||0.3063
72454085|NCT03274076|144431762|SUPERIORITY|||||||0.6|||||||Exact Wilcoxon|||H0: The absolute change in mRSS from week 0 to week 48 in placebo = The absolute change in mRSS from week 0 to week 48 in Tofacitinib.||||0.6000
72454086|NCT03274076|144431763|SUPERIORITY|||||||0.4535|||||||Exact Wilcoxon|||H0: The CRISS score at week 12 in placebo = The CRISS score at week 12 in Tofacitinib.||||0.4535
72454087|NCT03274076|144431763|SUPERIORITY|||||||0.8392|||||||Exact Wilcoxon|||H0: The CRISS score at week 24 in placebo = The CRISS score at week 24 in Tofacitinib.||||0.8392
72454088|NCT03274076|144431763|SUPERIORITY|||||||0.9212|||||||Exact Wilcoxon|||H0: The CRISS score at week 48 in placebo = The CRISS score at week 48 in Tofacitinib.||||0.9212
72454089|NCT00975585|144431764|NON_INFERIORITY_OR_EQUIVALENCE|Margin = 0.5|Mean Difference (Final Values)|-0.014|STANDARD_ERROR_OF_MEAN|0.02|||TWO_SIDED|97.46|-0.058|0.031|||Mixed Models Analysis||The mean difference is calculated as senofilcon A minus lotrafilcon B. Analysis is adjusted for lens type, site, lens type by site interaction as fixed effects, subject and eye nested within subject as random effects.|The alternative hypothesis is that senofilcon A contact lenses have non-inferior (less than or equal to) average corneal staining than lotrafilcon B after two weeks of wear.||0.031|-0.058|
72454090|NCT00975585|144431765|NON_INFERIORITY_OR_EQUIVALENCE|Margin = 0.25|Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.005|||TWO_SIDED|97.46|-0.021|-0.01|||Mixed Models Analysis||The mean difference is calculated as senofilcon A minus lotrafilcon B. Analysis adjusted for lens type, site, lens type by site interaction as fixed effects, subject and eye nested within subject as random effects.|The alternative hypothesis is that senofilcon A contact lenses are non-inferior (less than or equal to)in visual acuity to lotrafilcon B contact lenses after two weeks of wear.||-0.010|-0.021|
72454091|NCT00975585|144431766|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.402|STANDARD_ERROR_OF_MEAN|0.127|||TWO_SIDED|97.46|0.117|0.402|||Mixed Models Analysis||The mean difference is calculated as senofilcon A minus lotrafilcon B. Analysis adjusted for lens type, site, lens type by site interaction as fixed effects, subject as random effects.|The alternative hypothesis is that senofilcon A contact lenses have a higher rating of overall comfort than lotrafilcon B after two weeks of wear.||0.402|0.117|
72454092|NCT00975585|144431767|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.098|STANDARD_ERROR_OF_MEAN|0.141|||TWO_SIDED|97.46|-0.218|0.098|||Mixed Models Analysis||The mean difference is lotrafilcon B at 2 weeks minus lotrafilcon B at 4 weeks. Analysis adjusted for duration of wear, stie, duration of wear by site interaction as fixed effects, subject as random effects.|The alternative hypothesis is that lotrafilcon B contact lenses have a lower rating of overall comfort after 4 weeks of wear compared to after 2 weeks of wear.||0.098|-0.218|
72454093|NCT00975585|144431768|NON_INFERIORITY_OR_EQUIVALENCE|Margin = 0.5|Mean Difference (Final Values)|-0.123|STANDARD_ERROR_OF_MEAN|0.03|||TWO_SIDED|98.2|-0.123|-0.051|||Mixed Models Analysis||The mean difference is calculated as senofilcon A minus lotrafilcon B. Analysis adjusted for lens type, site, lens type by site interaction as fixed effects, subject and eye nested within subject as random effects.|The alternative hypothesis is that senofilcon A contact lenses are non-inferior in limbal redness 5 to lotrafilcon B contact lenses after two weeks of wear.||-0.051|-0.123|
72454094|NCT00975585|144431769|NON_INFERIORITY_OR_EQUIVALENCE|Margin = 0.5|Mean Difference (Final Values)|-0.068|STANDARD_ERROR_OF_MEAN|0.032|||TWO_SIDED|98.2|-0.068|0.008|||Mixed Models Analysis||The mean difference is calculated as senofilcon A minus lotrafilcon B. Analysis adjusted for lens type, site, lens type by site interaction as fixed effects, subject and eye nested within subject as random effects.|The alternative hypothesis is that senofilcon A contact lenses are non-inferior in bulbar redness to lotrafilcon B contact lenses after two weeks of wear.||0.008|-0.068|
72562466|NCT03449199|144656438|SUPERIORITY||Odds Ratio (OR)|1.72||||0.2791|TWO_SIDED||||||Regression, Logistic||Missing observations at Study Week 12 are imputed as nonresponse.|Odds ratio, 95% CLs, and p-values are obtained from logistic regression model adjusting for treatment group, randomization strata of Baseline sUA (\<6.0 vs ≥6.0 mg/dL) and Baseline UACR (200 to \<300 mg/g vs 300 to ≤3000 mg/g), Baseline UACR and Baseline sUA levels. Odds ratio for a baseline covariate is the ratio of odds over one unit increase of the covariate and it is assumed constant. P-value represents the statistical significance level of odds ratio differing from 1.||||0.2791
72562467|NCT03449199|144656438|SUPERIORITY||Odds Ratio (OR)|2.57||||0.0507|TWO_SIDED||||||Regression, Logistic|||Odds ratio, 95% CLs, and p-values are obtained from logistic regression model adjusting for treatment group, randomization strata of Baseline sUA (\<6.0 vs ≥6.0 mg/dL) and Baseline UACR (200 to \<300 mg/g vs 300 to ≤3000 mg/g), Baseline UACR and Baseline sUA levels. Odds ratio for a baseline covariate is the ratio of odds over one unit increase of the covariate and it is assumed constant. P-value represents the statistical significance level of odds ratio differing from 1.||||0.0507
72562468|NCT01091103|144656448|SUPERIORITY_OR_OTHER|||||||0.9427|TWO_SIDED|||||The p-value was not adjusted for multiplicity.|t-test, 2 sided|||||||0.9427
72562469|NCT01091103|144656449|SUPERIORITY_OR_OTHER|||||||0.337|TWO_SIDED|||||The p-value was not adjusted for multiplicity.|t-test, 2 sided|||||||0.3370
72454095|NCT00975585|144431770|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.411|STANDARD_ERROR_OF_MEAN|0.124|||TWO_SIDED|98.2|-0.411|-0.117|||Mixed Models Analysis||The mean difference is calculated as senofilcon A minus lotrafilcon B. Analysis adjusted for lens type, site, lens type by stie interaction as fixed effects, subject as random effects.|The alternative hypothesis is that senofilcon A contact lenses have less frequency of dryness than lotrafilcon B contact lenes after two weeks of wear.||-0.117|-0.411|
72454096|NCT00683800|144431772|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-2.89|||<|0.001|TWO_SIDED|95.0|-3.8|-1.98|||ANCOVA|||An analysis of covariance with treatment as factor and baseline value as a covariate was used to compare DVS SR 100 mg with matching placebo. The comparison was performed at significance level of p=0.05 (two sided).||-1.98|-3.80|<0.001
72454097|NCT00683800|144431773|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-2.79|||<|0.001|TWO_SIDED|95.0|-3.77|-1.82|||ANCOVA|||An analysis of covariance with treatment as factor and baseline value as a covariate was used to compare DVS SR 100 mg with matching placebo. The comparison was performed at significance level of p=0.05 (two sided).||-1.82|-3.77|<0.001
72454098|NCT00683800|144431774|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.28|||<|0.001|TWO_SIDED|95.0|-0.4|-0.16|||ANCOVA|||An analysis of covariance with treatment as factor and baseline value as a covariate was used to compare DVS SR 100 mg with matching placebo. The comparison was performed at significance level of p=0.05 (two sided).||-0.16|-0.40|<0.001
72454099|NCT00683800|144431775|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.31|||<|0.001|TWO_SIDED|95.0|-0.44|-0.18|||ANCOVA|||An analysis of covariance with treatment as factor and baseline value as a covariate was used to compare DVS SR 100 mg with matching placebo. The comparison was performed at significance level of p=0.05 (two sided).||-0.18|-0.44|<0.001
72454100|NCT00683800|144431776|SUPERIORITY_OR_OTHER||Wald Formula|-1.07|||||TWO_SIDED|90.0|-2.86|0.72|||||The 90% CI for excess risk was obtained using the Wald Formula.|Excess risk of DVS SR 100 mg over placebo per 1000 woman-years of exposure, defined as the difference in the exposure adjusted rates between the treatment groups, was obtained.||0.72|-2.86|
72454101|NCT00683800|144431777|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||The proportion of participants achieving a response as defined by minimal clinically important difference (MCID) at week 12 was compared between DVS and placebo treatment groups with a Cochran-Mantel-Haenszel test.||||<0.001
72454102|NCT00683800|144431778|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.47|||<|0.001|TWO_SIDED|95.0|2.24|5.36|||Regression, Logistic|||The proportion of participants achieving at least 50% hot flush reduction from baseline at 4-week was compared between DVS and placebo treatment groups with a logistic regression model with treatment as factor and baseline value as a covariate.||5.36|2.24|<0.001
72454103|NCT00683800|144431778|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.67|||<|0.001|TWO_SIDED|95.0|1.75|4.1|||Regression, Logistic|||The proportion of participants achieving at least 50% hot flush reduction from baseline at 12-week was compared between DVS and placebo treatment groups with a logistic regression model with treatment as factor and baseline value as a covariate.||4.10|1.75|<0.001
72454104|NCT00683800|144431779|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.39|||<|0.001|TWO_SIDED|95.0|2.47|7.81|||Regression, Logistic|||The proportion of participants achieving at least 75% hot flush reduction from baseline at 4-week was compared between DVS and placebo treatment groups with a logistic regression model with treatment as factor and baseline value as a covariate.||7.81|2.47|<0.001
72454105|NCT00683800|144431779|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.16|||<|0.001|TWO_SIDED|95.0|1.96|5.09|||Regression, Logistic|||The proportion of participants achieving at least 75% hot flush reduction from baseline at 12-week was compared between DVS and placebo treatment groups with a logistic regression model with treatment as factor and baseline value as a covariate.||5.09|1.96|<0.001
72454106|NCT00683800|144431780|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Log Rank|||A log-rank test was used to compare the treatment groups.||||<0.001
72454107|NCT00683800|144431781|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-2.04|||<|0.001|TWO_SIDED|95.0|-3.07|-1.0|||ANCOVA|||An analysis of covariance with treatment as factor and baseline value as a covariate was used to compare DVS SR 100 mg with matching placebo. The comparison was performed at significance level of p=0.05 (two sided). (At month 6)||-1.00|-3.07|<0.001
72454108|NCT00683800|144431781|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-2.81|||<|0.001|TWO_SIDED|95.0|-4.12|-1.51|||ANCOVA|||An analysis of covariance with treatment as factor and baseline value as a covariate was used to compare DVS SR 100 mg with matching placebo. The comparison was performed at significance level of p=0.05 (two sided). (At month 12)||-1.51|-4.12|<0.001
72454109|NCT00683800|144431782|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.31||||0.002|TWO_SIDED|95.0|-0.51|-0.12|||ANCOVA|||An analysis of covariance with treatment as factor and baseline value as a covariate was used to compare DVS SR 100 mg with matching placebo. The comparison was performed at significance level of p=0.05 (two sided). (At month 6)||-0.12|-0.51|0.002
72454110|NCT00683800|144431782|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.33||||0.003|TWO_SIDED|95.0|-0.54|-0.11|||ANCOVA|||An analysis of covariance with treatment as factor and baseline value as a covariate was used to compare DVS SR 100 mg with matching placebo. The comparison was performed at significance level of p=0.05 (two sided). (At month 12)||-0.11|-0.54|0.003
72454111|NCT00683800|144431783|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-2.34|||<|0.001|TWO_SIDED|95.0|-3.05|-1.64|||Mixed Models Analysis|||For Week 12: Change from baseline of the GCS Total score was analyzed using a Mixed-effects model repeated measures (MMRM), for which changes from baseline at week 12, month 6, and month 12 were outcome variables, with treatment, week, and interaction between treatment and week as fixed effects with participant as a random effect, and with the baseline score as covariate.||-1.64|-3.05|<0.001
72454112|NCT00683800|144431783|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.75|||<|0.001|TWO_SIDED|95.0|-0.99|-0.51|||Mixed Models Analysis|||For Week 12: Change from baseline of the GCS Anxiety scale subscore was analyzed using a Mixed-effects model repeated measures (MMRM), for which changes from baseline at week 12, month 6, and month 12 were outcome variables, with treatment, week, and interaction between treatment and week as fixed effects with participant as a random effect, and with the baseline score as covariate.||-0.51|-0.99|<0.001
72562470|NCT02780167|144656483|OTHER||Estimate difference|1.8|STANDARD_ERROR_OF_MEAN|0.99||0.121|TWO_SIDED|95.0|-0.7|4.4|||Emax model|Emax model with non-responder imputation (NRI)|Test group: PF-04965842 10 mg QD, Reference group: Placebo.|||4.4|-0.7|0.1210
72562471|NCT02780167|144656483|OTHER||Estimate difference|6.0|STANDARD_ERROR_OF_MEAN|3.05||0.1065|TWO_SIDED|95.0|-1.8|13.8|||Emax model|Emax model with non-responder imputation (NRI)|Test group: PF-04965842 30 mg QD, Reference group: Placebo.|||13.8|-1.8|0.1065
72562472|NCT02780167|144656483|OTHER||Estimate difference|21.5|STANDARD_ERROR_OF_MEAN|6.25||0.0184|TWO_SIDED|95.0|5.5|37.6|||Emax model|Emax model with non-responder imputation (NRI)|Test group: PF-04965842 100 mg QD, Reference group: Placebo.|||37.6|5.5|0.0184
72562473|NCT02780167|144656483|OTHER||Mean Difference (Final Values)|38.2|STANDARD_ERROR_OF_MEAN|7.18||0.0032|TWO_SIDED|95.0|19.7|56.6|||Emax model|Emax model with non-responder imputation (NRI)|Test group: PF-04965842 200 mg QD, Reference group: Placebo.|||56.6|19.7|0.0032
72562474|NCT02780167|144656484|OTHER||LS mean difference|4.08|STANDARD_ERROR_OF_MEAN|9.667||0.6731|TWO_SIDED|90.0|-11.88|20.05|||Mixed Models Analysis|Mixed-effects model repeated measures (MMRM) with observed cases (OC)|Test group: PF-04965842 10 mg QD, Reference group: Placebo.|||20.05|-11.88|0.6731
72562475|NCT02780167|144656484|OTHER||LS mean difference|-5.52|STANDARD_ERROR_OF_MEAN|9.474||0.561|TWO_SIDED|90.0|-21.16|10.13|||Mixed Models Analysis|MMRM with OC|Test group: PF-04965842 30 mg QD, Reference group: Placebo.|||10.13|-21.16|0.5610
72562476|NCT02780167|144656484|OTHER||LS mean difference|-23.82|STANDARD_ERROR_OF_MEAN|9.043||0.0091|TWO_SIDED|90.0|-38.76|-8.88|||Mixed Models Analysis|MMRM with OC|Test group: PF-04965842 100 mg QD, Reference group: Placebo.|||-8.88|-38.76|0.0091
72620244|NCT00600704|144771576|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.379|STANDARD_DEVIATION|0.096|<|0.05|TWO_SIDED|95.0|0.189|0.569|||t-test, 2 sided|||Sample size calculation was based on a two-sided alpha error of .05 and 80% power. After applying the protocol in two equal groups of 10 patients, the analysis showed that the study requires 60 patients per group. However, we decided to enroll up to 100 patients per group to allow for patient attrition or missing data, and also in order to look for differences with regards to transfusion between patient subgroups.||0.569|0.189|<0.05
72620245|NCT00600704|144771576|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.797|STANDARD_ERROR_OF_MEAN|0.168|<|0.05|TWO_SIDED|95.0|0.465|1.129|||Regression, Linear||The mean difference between groups B and A is adjusted for age, gender, BMI and preoperative HCT, while BSA, weight, height, postoperative HCT were not included in the final model to avoid collinearity.|Null hypothesis :restrictive fluid protocol does not have any effect concerning the mean number of PRC units transfused.||1.129|0.465|<0.05
72562477|NCT02780167|144656484|OTHER||LS mean difference|-47.35|STANDARD_ERROR_OF_MEAN|9.008|<|0.0001|TWO_SIDED|90.0|-62.23|-32.47|||Mixed Models Analysis|MMRM with OC|Test group: PF-04965842 200 mg QD, Reference group: Placebo.|||-32.47|-62.23|<0.0001
72562478|NCT03180801|144656508|OTHER|||||||0.03|||||||Fisher Exact|||One-sided Fisher exact test is used to test if vaccine group has lower MMID rate than placebo.||||0.03
72562479|NCT03180801|144656508|OTHER|||||||0.07|||||||Fisher Exact|||One-sided Fisher exact test is used to test if vaccine group has lower MMID rate than placebo.||||0.07
72562480|NCT03180801|144656509|OTHER|One sided Fisher's exact test is used to test if TEAE rates of vaccine group is higher than the placebo group.||||||0.647|||||||Fisher Exact|||One sided Fisher's exact test is used to test if the TEAE rates pre-inoculation recorded for the treatment group are higher than for placebo.||||0.647
72562481|NCT03180801|144656509|OTHER|||||||1|||||||Fisher Exact|||One-sided Fisher's exact test is used to test if TEAE rate of vaccine group recorded pre-inoculation is higher than placebo.||||1.00
72620246|NCT00215553|144771629|SUPERIORITY_OR_OTHER|||||||0.794||95.0|||||Cochran-Mantel-Haenszel|||Null hypothesis: No difference between treatment groups||||0.794
72620247|NCT00215553|144771629|SUPERIORITY_OR_OTHER|||||||0.236||95.0|||||Cochran-Mantel-Haenszel|||Null hypothesis: No difference between treatment groups||||0.236
72620248|NCT00215553|144771629|SUPERIORITY_OR_OTHER|||||||0.396||95.0|||||Cochran-Mantel-Haenszel|||Null hypothesis: No difference between treatment groups||||0.396
72620249|NCT00215553|144771630|SUPERIORITY_OR_OTHER|||||||0.346||95.0|||||Cochran-Mantel-Haenszel|||||||0.346
72562482|NCT03180801|144656509|OTHER|||||||0.024|||||||Fisher Exact|||One sided Fisher's exact test is used to test if TEAE rate of vaccine group post-inoculation is higher than the placebo group.||||0.0240
72562483|NCT03180801|144656509|OTHER|||||||0.186|||||||Fisher Exact|||One sided Fisher's exact test is used to test if TEAE rate of vaccine group post-inoculation is higher than the placebo group.||||0.186
72562484|NCT03180801|144656511|OTHER|||||||0.465|||||||Fisher Exact|||One-sided Fisher exact test is used to test if vaccine group has lower rate of subjects experiencing at least one symptom||||0.465
72562485|NCT03180801|144656511|OTHER|||||||0.074|||||||Fisher Exact|||One-sided Fisher exact test is used to test if vaccine group has lower rate of subjects experiencing at least one symptom||||0.074
72562486|NCT03180801|144656511|OTHER|||||||0.024|||||||Fisher Exact|||One-sided Fisher exact test is used to test if vaccine group has lower rate of subjects experiencing at least two symptoms||||0.024
72562487|NCT03180801|144656511|OTHER|||||||0.23|||||||Fisher Exact|||One-sided Fisher exact test is used to test if vaccine group has lower rate of subjects experiencing at least two symptoms.||||0.230
72562488|NCT03180801|144656511|OTHER|||||||0.09|||||||Fisher Exact|||One-sided Fisher exact test is used to test if vaccine group has lower rate of subjects with detectable virus shedding||||0.09
72562489|NCT03180801|144656511|OTHER|||||||0.22|||||||Fisher Exact|||One-sided Fisher exact test is used to test if vaccine group has lower rate of subjects with detectable virus shedding||||0.22
72562490|NCT03180801|144656511|OTHER|||||||0.23|||||||Fisher Exact|||One-sided Fisher exact test is used to test if vaccine group has lower rate of subjects asymptomatic with detectable virus shedding||||0.23
72562491|NCT03180801|144656511|OTHER|||||||0.12|||||||Fisher Exact|||One-sided Fisher exact test is used to test if vaccine group has lower rate of subjects asymptomatic with detectable virus shedding||||0.12
72562492|NCT03180801|144656512|OTHER|||||||0.0501|||||||Wilcoxon (Mann-Whitney)|||One-sided Wilcoxon test is used to test if vaccine group has shorter shedding duration than placebo.||||0.0501
72562493|NCT03180801|144656512|OTHER|||||||0.3139|||||||Wilcoxon (Mann-Whitney)|||One-sided Wilcoxon test is used to test if vaccine group has shorter shedding duration than placebo.||||0.3139
72562494|NCT03180801|144656513|OTHER|||||||0.102|||||||Wilcoxon (Mann-Whitney)|||One-sided Wilcoxon test is used to test if vaccine group has smaller shedding AUC than placebo.||||0.102
72562495|NCT03180801|144656513|OTHER|||||||0.481|||||||Wilcoxon (Mann-Whitney)|||One-sided Wilcoxon test is used to test if vaccine group has a smaller shedding AUC than placebo.||||0.481
72620250|NCT00215553|144771630|SUPERIORITY_OR_OTHER|||||||0.286||95.0|||||Cochran-Mantel-Haenszel|||||||0.286
72620251|NCT00215553|144771630|SUPERIORITY_OR_OTHER|||||||0.964||95.0|||||Cochran-Mantel-Haenszel|||||||0.964
72499636|NCT01431287|144529533|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.048|STANDARD_ERROR_OF_MEAN|0.025||0.0621|TWO_SIDED|95.0|-0.002|0.097||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.097|-0.002|0.0621
72499637|NCT01431287|144529533|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.039|STANDARD_ERROR_OF_MEAN|0.025||0.1266|TWO_SIDED|95.0|-0.011|0.089||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.089|-0.011|0.1266
72499638|NCT01431287|144529534|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.156|STANDARD_ERROR_OF_MEAN|0.027|<|0.0001|TWO_SIDED|95.0|0.104|0.209||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.209|0.104|<0.0001
72499639|NCT01431287|144529534|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.087|STANDARD_ERROR_OF_MEAN|0.027||0.0013|TWO_SIDED|95.0|0.034|0.139||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.139|0.034|0.0013
72499640|NCT01431287|144529534|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.17|STANDARD_ERROR_OF_MEAN|0.027|<|0.0001|TWO_SIDED|95.0|0.118|0.223||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.223|0.118|<0.0001
72499641|NCT01431287|144529534|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.102|STANDARD_ERROR_OF_MEAN|0.027||0.0001|TWO_SIDED|95.0|0.049|0.154||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.154|0.049|0.0001
72499642|NCT01431287|144529534|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.1|STANDARD_ERROR_OF_MEAN|0.027||0.0002|TWO_SIDED|95.0|0.048|0.153||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.153|0.048|0.0002
72562496|NCT03180801|144656514|OTHER|||||||0.128|||||||Wilcoxon (Mann-Whitney)|||One-sided Wilcoxon test is used to test if vaccine group has lower peak viral shedding than placebo.||||0.128
72562497|NCT03180801|144656514|OTHER|||||||0.601|||||||Wilcoxon (Mann-Whitney)|||One-sided Wilcoxon test is used to test if vaccine group has lower peak viral shedding than placebo.||||0.601
72620252|NCT00215553|144771631|SUPERIORITY_OR_OTHER|||||||0.028||95.0|||||ANOVA|ANOVA on ranks||||||0.028
72562498|NCT03180801|144656515|OTHER|||||||0.142|||||||Wilcoxon (Mann-Whitney)|||One-sided Wilcoxon test is used to test if vaccine group has shorter duration of symptoms than placebo.||||0.142
72562499|NCT03180801|144656515|OTHER|||||||0.147|||||||Wilcoxon (Mann-Whitney)|||One-sided Wilcoxon test is used to test if vaccine group has shorter duration of symptoms than placebo.||||0.147
72562500|NCT03180801|144656516|OTHER|||||||0.08|||||||Wilcoxon (Mann-Whitney)|||One-sided Wilcoxon test is used to test if vaccine group has fewer average number of symptoms than placebo.||||0.080
72562501|NCT03180801|144656516|OTHER|||||||0.271|||||||Wilcoxon (Mann-Whitney)|||One-sided Wilcoxon test is used to test if vaccine group has fewer average number of symptoms than placebo.||||0.271
72562502|NCT03180801|144656517|OTHER|||||||0.099|||||||Wilcoxon (Mann-Whitney)|||One-sided Wilcoxon test is used to test if vaccine group has fewer peak symptoms than placebo.||||0.099
72562503|NCT03180801|144656517|OTHER|||||||0.178|||||||Wilcoxon (Mann-Whitney)|||One-sided Wilcoxon test is used to test if vaccine group has fewer peak symptoms than placebo.||||0.178
72620253|NCT00215553|144771631|SUPERIORITY_OR_OTHER|||||||0.147||95.0|||||ANOVA|ANOVA on ranks||||||0.147
72620254|NCT00215553|144771631|SUPERIORITY_OR_OTHER|||||||0.293||95.0|||||ANOVA|ANOVA on ranks||||||0.293
72620255|NCT00159874|144771680|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-7.02|STANDARD_ERROR_OF_MEAN|6.1||0.253|TWO_SIDED|95.0|-19.13|5.09|||ANCOVA||Least square mean difference of -7.02 was calculated as ' Sildenafil Medium Dose - Low Dose'|Analyses were performed using analysis of covariance with etiology, weight, day of assessment and baseline peak VO2 as the covariates.||5.09|-19.13|0.253
72562504|NCT03180801|144656518|OTHER|||||||0.064|||||||Wilcoxon (Mann-Whitney)|||One-sided Wilcoxon test is used to test if vaccine group has lower FLU-PRO scores than placebo.||||0.064
72562505|NCT03180801|144656518|OTHER|||||||0.201|||||||Wilcoxon (Mann-Whitney)|||One-sided Wilcoxon test is used to test if vaccine group has lower FLU-PRO scores than placebo.||||0.201
72562506|NCT03180801|144656519|OTHER||||||<|0.001|||||||t-test, 2 sided|||comparison on day -2||||<0.001
72562507|NCT03180801|144656519|OTHER||||||<|0.001|||||||t-test, 2 sided|||Comparion on day -2||||<0.001
72562508|NCT03180801|144656519|OTHER||||||<|0.001|||||||t-test, 2 sided|||Comparison on day 35||||<0.001
72562509|NCT03180801|144656519|OTHER||||||<|0.001|||||||t-test, 2 sided|||Comparison on day 35||||<0.001
72620256|NCT00159874|144771680|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-9.84|STANDARD_ERROR_OF_MEAN|5.92||0.1|TWO_SIDED|95.0|-21.6|1.93|||ANCOVA||Least square mean difference of -9.84 was calculated as ' Sildenafil High Dose - Low Dose'|Analyses were performed using analysis of covariance with etiology, weight, day of assessment and baseline peak VO2 as the covariates.||1.93|-21.60|0.100
72499643|NCT01431287|144529534|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.014|STANDARD_ERROR_OF_MEAN|0.027||0.6093|TWO_SIDED|95.0|-0.066|0.039||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.039|-0.066|0.6093
72499644|NCT01431287|144529534|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.088|STANDARD_ERROR_OF_MEAN|0.027||0.0011|TWO_SIDED|95.0|0.035|0.14||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.140|0.035|0.0011
72499645|NCT01431287|144529534|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.07|STANDARD_ERROR_OF_MEAN|0.027||0.0095|TWO_SIDED|95.0|0.017|0.123||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.123|0.017|0.0095
72499646|NCT01431287|144529534|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.069|STANDARD_ERROR_OF_MEAN|0.027||0.0108|TWO_SIDED|95.0|0.016|0.121||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.121|0.016|0.0108
72499647|NCT01431287|144529534|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.001|STANDARD_ERROR_OF_MEAN|0.027||0.9627|TWO_SIDED|95.0|-0.051|0.054||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.054|-0.051|0.9627
72499648|NCT01431287|144529535|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.118|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001|TWO_SIDED|95.0|0.074|0.162||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA|||||0.162|0.074|<0.0001
72499649|NCT01431287|144529535|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.123|STANDARD_ERROR_OF_MEAN|0.023|<|0.0001|TWO_SIDED|95.0|0.077|0.169||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA|||||0.169|0.077|<0.0001
72499650|NCT01431287|144529535|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.071|STANDARD_ERROR_OF_MEAN|0.022||0.0012|TWO_SIDED|95.0|0.028|0.114||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA|||||0.114|0.028|0.0012
72499651|NCT01431287|144529535|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.094|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001|TWO_SIDED|95.0|0.05|0.137||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA|||||0.137|0.050|<0.0001
72499652|NCT01431287|144529535|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.076|STANDARD_ERROR_OF_MEAN|0.023||0.001|TWO_SIDED|95.0|0.031|0.121||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA|||||0.121|0.031|0.0010
72499653|NCT01431287|144529535|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.047|STANDARD_ERROR_OF_MEAN|0.023||0.0384|TWO_SIDED|95.0|0.003|0.092||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA|||||0.092|0.003|0.0384
72499654|NCT01431287|144529535|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.141|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001|TWO_SIDED|95.0|0.097|0.185||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA|||||0.185|0.097|<0.0001
72499655|NCT01431287|144529535|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.004|STANDARD_ERROR_OF_MEAN|0.023||0.8428|TWO_SIDED|95.0|-0.049|0.04||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA|||||0.040|-0.049|0.8428
72499656|NCT01431287|144529535|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.022|STANDARD_ERROR_OF_MEAN|0.022||0.3048|TWO_SIDED|95.0|-0.065|0.02||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA|||||0.020|-0.065|0.3048
72499657|NCT01431287|144529535|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.018|STANDARD_ERROR_OF_MEAN|0.023||0.4311|TWO_SIDED|95.0|-0.027|0.063||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA|||||0.063|-0.027|0.4311
72499658|NCT01431287|144529536|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.098|STANDARD_ERROR_OF_MEAN|0.021|<|0.0001|TWO_SIDED|95.0|0.057|0.139||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA|||||0.139|0.057|<0.0001
72499659|NCT01431287|144529536|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.106|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001|TWO_SIDED|95.0|0.063|0.149||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA|||||0.149|0.063|<0.0001
72499660|NCT01431287|144529536|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.051|STANDARD_ERROR_OF_MEAN|0.021||0.0136|TWO_SIDED|95.0|0.01|0.091||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA|||||0.091|0.010|0.0136
72499661|NCT01431287|144529536|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.075|STANDARD_ERROR_OF_MEAN|0.021||0.0003|TWO_SIDED|95.0|0.035|0.116||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA|||||0.116|0.035|0.0003
72499662|NCT01431287|144529536|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.059|STANDARD_ERROR_OF_MEAN|0.022||0.0065|TWO_SIDED|95.0|0.016|0.101||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA|||||0.101|0.016|0.0065
72499663|NCT01431287|144529536|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.047|STANDARD_ERROR_OF_MEAN|0.021||0.0277|TWO_SIDED|95.0|0.005|0.089||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA|||||0.089|0.005|0.0277
72499664|NCT01431287|144529536|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.122|STANDARD_ERROR_OF_MEAN|0.021|<|0.0001|TWO_SIDED|95.0|0.081|0.164||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA|||||0.164|0.081|<0.0001
72499665|NCT01431287|144529536|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.008|STANDARD_ERROR_OF_MEAN|0.021||0.7116|TWO_SIDED|95.0|-0.049|0.034||Comments ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA|||||0.034|-0.049|0.7116
72499666|NCT01431287|144529536|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.024|STANDARD_ERROR_OF_MEAN|0.02||0.2332|TWO_SIDED|95.0|-0.065|0.016||Comments ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA|||||0.016|-0.065|0.2332
72391718|NCT00256750|144290822|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.5|||<|0.0001|TWO_SIDED|97.3|8.5|20.5||To account for missing measured GFR due to graft loss or death, an ANOVA model on the ranks of measured GFR (with imputed missing values) at Months 24 with factor for randomization group was applied. Measured GFR missing were assigned the worst rank.|Kruskal-Wallis|Tests comparing a belatacept to CsA were based on the Kruskal-Wallis test (using a chi-square approximation of the distribution of the test statistic)|Test were conducted at a level of 0.027 (2-sided).|Time Frame = Day 1 to Month 24||20.5|8.5|<0.0001
72391719|NCT00256750|144290823|NON_INFERIORITY_OR_EQUIVALENCE|Test of superiority using DerSimonian-Laird statistic at 0.027 level of significance.|Difference in Percent|-8.5||||0.0581|TWO_SIDED|97.3|-17.9|0.9|||Chi-squared, Corrected|A continuity corrected chi-square test at a significance level of 0.027 was performed.||||0.9|-17.9|0.0581
72391720|NCT00256750|144290823|NON_INFERIORITY_OR_EQUIVALENCE|Test of superiority using DerSimonian-Laird statistic at 0.027 level of significance.|Difference in Percent|-14.2||||0.001|TWO_SIDED|97.3|-23.2|-5.0|||Chi-squared, Corrected|A continuity corrected chi-square test at a significance level of 0.027 was performed.||||-5.0|-23.2|0.0010
72391721|NCT00256750|144290828|SUPERIORITY_OR_OTHER||Difference in Percent|-8.5|||||TWO_SIDED|97.3|-14.6|-3.3|||||For 97.3% CI of difference, normal approximation is used if N\>=5 in both arms. Otherwise exact method is used.|Percent treatment difference measured as Belatacept - LI minus Cyclosporine||-3.3|-14.6|
72391722|NCT00256750|144290828|SUPERIORITY_OR_OTHER||Difference in Percent|-10.3|||||TWO_SIDED|97.3|-16.1|-5.1|||||For 97.3% CI of difference, normal approximation is used if N\>=5 in both arms. Otherwise exact method is used.|Percent treatment difference measured as Belatacept - LI minus Cyclosporine||-5.1|-16.1|
72391723|NCT00256750|144290832|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|15.3|||||TWO_SIDED|97.3|10.3|20.3|||||ANOVA model: GFR = treatment|Month 12||20.3|10.3|
72391724|NCT00256750|144290832|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|15.1|||||TWO_SIDED|97.3|10.1|20.1|||||ANOVA model: GFR = treatment|Month 12||20.1|10.1|
72391725|NCT00256750|144290832|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|17.5|||||TWO_SIDED|97.3|12.0|23.1|||||ANOVA model: GFR = treatment|Month 24||23.1|12.0|
72454113|NCT00683800|144431783|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.67|||<|0.001|TWO_SIDED|95.0|-0.89|-0.45|||Mixed Models Analysis|||For Week 12: Change from baseline of the GCS Depression scale subscore was analyzed using a Mixed-effects model repeated measures (MMRM), for which changes from baseline at week 12, month 6, and month 12 were outcome variables, with treatment, week, and interaction between treatment and week as fixed effects with participant as a random effect, and with the baseline score as covariate.||-0.45|-0.89|<0.001
72562510|NCT03180801|144656519|OTHER||||||<|0.001|||||||t-test, 2 sided|||Comparison on day 63||||<0.001
72391726|NCT00256750|144290832|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|17.6|||||TWO_SIDED|97.3|12.0|23.3|||||ANOVA model: GFR = treatment|Month 24||23.3|12.0|
72391727|NCT00256750|144290832|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|21.4|||||TWO_SIDED|97.3|15.4|27.4|||||ANOVA model: GFR = treatment|Month 36||27.4|15.4|
72391728|NCT00256750|144290832|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|20.8|||||TWO_SIDED|97.3|14.8|26.9|||||ANOVA model: GFR = treatment|Month 36||26.9|14.8|
72391729|NCT00256750|144290834|SUPERIORITY_OR_OTHER||Difference in Percent|-5.7||||0.0687|TWO_SIDED|97.3|-12.6|0.5||Normal approximation is used if N\>=5 in both arms. Otherwise, exact method is used.|Chi-squared|||Month 12||0.5|-12.6|0.0687
72391730|NCT00256750|144290834|SUPERIORITY_OR_OTHER||Difference in Percent|-2.8||||0.4825|TWO_SIDED|97.3|-10.2|4.4||Normal approximation is used if N\>=5 in both arms. Otherwise, exact method is used.|Chi-squared|||Month 12||4.4|-10.2|0.4825
72391731|NCT00256750|144290834|SUPERIORITY_OR_OTHER||Difference in Percent|-5.1||||0.1267|TWO_SIDED|97.3|-12.3|1.5||Normal approximation is used if N\>=5 in both arms. Otherwise, exact method is used.|Chi-squared|||Month 24||1.5|-12.3|0.1267
72391732|NCT00256750|144290834|SUPERIORITY_OR_OTHER||Difference in Percent|-2.2||||0.6405|TWO_SIDED|97.3|-9.8|5.4||Normal approximation is used if N\>=5 in both arms. Otherwise, exact method is used.|Chi-squared|||Month 24||5.4|-9.8|0.6405
72391733|NCT00256750|144290834|SUPERIORITY_OR_OTHER||Difference in Percent|-4.6||||0.2043|TWO_SIDED|97.3|-12.0|2.5|||Chi-squared|Normal approximation is used if N\>=5 in both arms. Otherwise, exact method is used.||Month 36||2.5|-12.0|0.2043
72391734|NCT00256750|144290834|SUPERIORITY_OR_OTHER||Difference in Percent|-0.9||||0.9481|TWO_SIDED|97.3|-8.8|7.1||Normal approximation is used if N\>=5 in both arms. Otherwise, exact method is used.|Chi-squared|||Month 36||7.1|-8.8|0.9481
72391735|NCT00256750|144290835|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.5||||0.0002|TWO_SIDED|97.3|0.31|0.74|||Chi-squared||Odds ratio is estimated by a cumulative logit model.|||0.74|0.31|0.0002
72391736|NCT00256750|144290835|SUPERIORITY_OR_OTHER||Odds Ratio, log|0.6||||0.0092|TWO_SIDED|97.3|0.38|0.92|||Chi-squared||Odds ratio is estimated by a cumulative logit model.|||0.92|0.38|0.0092
72391737|NCT00256750|144290836|SUPERIORITY_OR_OTHER||Difference in Percent|-21.2|||||TWO_SIDED|97.3|-67.6|43.2|||||For 97.3% CI of difference, normal approximation is used if N\>=5 in both arms. Otherwise exact method is used.|Month 12||43.2|-67.6|
72391738|NCT00256750|144290836|SUPERIORITY_OR_OTHER||Difference in Percent|-17.9|||||TWO_SIDED|97.3|-72.3|52.2|||||For 97.3% CI of difference, normal approximation is used if N\>=5 in both arms. Otherwise exact method is used.|Month 12||52.2|-72.3|
72391739|NCT00256750|144290837|SUPERIORITY_OR_OTHER||Difference in Percent|-1.13|||||TWO_SIDED|97.3|-7.51|5.23|||||For 97.3% CI of difference, normal approximation is used if N\>=5 in both arms. Otherwise exact method is used.|Month 12||5.23|-7.51|
72391740|NCT00256750|144290837|SUPERIORITY_OR_OTHER||Difference in Percent|-2.37|||||TWO_SIDED|97.3|-9.01|4.15|||||For 97.3% CI of difference, normal approximation is used if N\>=5 in both arms. Otherwise exact method is used.|Month 12||4.15|-9.01|
72391741|NCT00256750|144290838|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|-7.3|||||TWO_SIDED|97.3|-11.4|-3.3||||||Systolic, Month 12||-3.3|-11.4|
72391742|NCT00256750|144290838|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|-6.0|||||TWO_SIDED|97.3|-10.1|-2.0||||||Systolic, Month 12||-2.0|-10.1|
72391743|NCT00256750|144290838|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|-3.2|||||TWO_SIDED|97.3|-5.8|-0.7||||||Diastolic, Month 12||-0.7|-5.8|
72391744|NCT00256750|144290838|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|-2.6|||||TWO_SIDED|97.3|-5.1|0.0||||||Diastolic, Month 12||0.0|-5.1|
72391745|NCT00256750|144290838|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|-4.9|||||TWO_SIDED|97.3|-9.2|-0.6||||||Systolic, Month 24||-0.6|-9.2|
72391746|NCT00256750|144290838|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|-5.5|||||TWO_SIDED|97.3|-9.9|-1.1||||||Systolic, Month 24||-1.1|-9.9|
72391747|NCT00256750|144290838|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|-1.9|||||TWO_SIDED|97.3|-4.4|0.5||||||Diastolic, Month 24||0.5|-4.4|
72391748|NCT00256750|144290838|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|-2.4|||||TWO_SIDED|97.3|-5.0|0.1||||||Diastolic, Month 24||0.1|-5.0|
72391749|NCT00256750|144290838|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|-5.8|||||TWO_SIDED|97.3|-10.0|-1.6||||||Systolic, Month 36||-1.6|-10.0|
72391750|NCT00256750|144290838|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|-7.5|||||TWO_SIDED|97.3|-11.7|-3.3||||||Systolic, Month 36||-3.3|-11.7|
72391751|NCT00256750|144290838|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|-2.9|||||TWO_SIDED|97.3|-5.4|-0.4||||||Diastolic, Month 36||-0.4|-5.4|
72391752|NCT00256750|144290838|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|-3.4|||||TWO_SIDED|97.3|-6.0|-0.9||||||Diastolic, Month 36||-0.9|-6.0|
72391753|NCT00256750|144290839|SUPERIORITY_OR_OTHER||Difference in Percent|7.1|||||TWO_SIDED|97.3|-2.9|17.1|||||A continuity-corrected Chi-square test at significance level 0.027 was performed for the difference between the belatacept regimen and cyclosporine|At Month 12||17.1|-2.9|
72391754|NCT00256750|144290839|SUPERIORITY_OR_OTHER||Difference in Percent|3.2|||||TWO_SIDED|97.3|-6.6|12.9|||||A continuity-corrected Chi-square test at significance level 0.027 was performed for the difference between the belatacept regimen and cyclosporine|At Month 12||12.9|-6.6|
72391755|NCT00256750|144290840|SUPERIORITY_OR_OTHER||Difference in Percent|7.01|||||TWO_SIDED|97.3|-2.79|16.71|||||A continuity-corrected Chi-square test at significance level 0.027 was performed for the difference between the belatacept regimen and cyclosporine|||16.71|-2.79|
72391756|NCT00256750|144290840|SUPERIORITY_OR_OTHER||Difference in Percent|3.77|||||TWO_SIDED|97.3|-5.86|13.35|||||A continuity-corrected Chi-square test at significance level 0.027 was performed for the difference between the belatacept regimen and cyclosporine|||13.35|-5.86|
72391757|NCT00256750|144290845|SUPERIORITY_OR_OTHER||Difference in Percent|-10.4|||||TWO_SIDED|97.3|-21.4|1.0||||||||1.0|-21.4|
72391758|NCT00256750|144290845|SUPERIORITY_OR_OTHER||Difference in Percent|-8.7|||||TWO_SIDED|97.3|-19.9|2.7||||||||2.7|-19.9|
72391759|NCT00256750|144290847|NON_INFERIORITY_OR_EQUIVALENCE|A 20% margin for non-inferiority was used and provides 99% power to ascertain that the upper bound of the 97.3% 2-sided confidence intervals for the absolute difference between each belatacept regimen and cyclosporine, assuming the true acute rejection rate by 12 months is 15% for all three regimens|Difference in Percent|11.4|||||TWO_SIDED|97.3|5.0|18.2|||||For 97.3% CI of difference, normal approximation is used if N\>=5 in both arms. Otherwise exact method is used.|Month 6||18.2|5.0|
72391760|NCT00256750|144290847|NON_INFERIORITY_OR_EQUIVALENCE|A 20% margin for non-inferiority was used and provides 99% power to ascertain that the upper bound of the 97.3% 2-sided confidence intervals for the absolute difference between each belatacept regimen and cyclosporine, assuming the true acute rejection rate by 12 months is 15% for all three regimens|Difference in Percent|16.5|||||TWO_SIDED|97.3|9.6|23.8|||||For 97.3% CI of difference, normal approximation is used if N\>=5 in both arms. Otherwise exact method is used.|Month 6||23.8|9.6|
72391761|NCT00256750|144290847|NON_INFERIORITY_OR_EQUIVALENCE|A 20% margin for non-inferiority was used and provides 99% power to ascertain that the upper bound of the 97.3% 2-sided confidence intervals for the absolute difference between each belatacept regimen and cyclosporine, assuming the true acute rejection rate by 12 months is 15% for all three regimens.|Difference in Percent|8.2|||||TWO_SIDED|97.3|1.2|15.4|||||For 97.3% CI of difference, normal approximation is used if N\>=5 in both arms. Otherwise exact method is used|Month 24||15.4|1.2|
72391762|NCT00256750|144290847|NON_INFERIORITY_OR_EQUIVALENCE|A 20% margin for non-inferiority was used and provides 99% power to ascertain that the upper bound of the 97.3% 2-sided confidence intervals for the absolute difference between each belatacept regimen and cyclosporine, assuming the true acute rejection rate by 12 months is 15% for all three regimens.|Difference in Percent|15.2|||||TWO_SIDED|97.3|7.5|23.0|||||For 97.3% CI of difference, normal approximation is used if N\>=5 in both arms. Otherwise exact method is used.|Month 24||23.0|7.5|
72391763|NCT00256750|144290847|NON_INFERIORITY_OR_EQUIVALENCE|A 20% margin for non-inferiority was used and provides 99% power to ascertain that the upper bound of the 97.3% 2-sided confidence intervals for the absolute difference between each belatacept regimen and cyclosporine, assuming the true acute rejection rate by 12 months is 15% for all three regimens.|Difference in Percent|7.8|||||TWO_SIDED|97.3|0.6|15.0|||||For 97.3% CI of difference, normal approximation is used if N\>=5 in both arms. Otherwise exact method is used.|Month 36||15.0|0.6|
72391764|NCT00256750|144290847|NON_INFERIORITY_OR_EQUIVALENCE|A 20% margin for non-inferiority was used and provides 99% power to ascertain that the upper bound of the 97.3% 2-sided confidence intervals for the absolute difference between each belatacept regimen and cyclosporine, assuming the true acute rejection rate by 12 months is 15% for all three regimens.|Difference in Percent|14.7|||||TWO_SIDED|97.3|7.0|22.6|||||For 97.3% CI of difference, normal approximation is used if N\>=5 in both arms. Otherwise exact method is used.|Month 36||22.6|7.0|
72391765|NCT00256750|144290849|SUPERIORITY_OR_OTHER||Difference in Percent|-3.2|||||TWO_SIDED|95.0|-6.6|-0.6|||||For 95% CI of difference, normal approximation is used if N\>=5 in both arms. Otherwise exact method is used.|||-0.6|-6.6|
72391766|NCT00256750|144290849|SUPERIORITY_OR_OTHER||Difference in Percent|-3.2|||||TWO_SIDED|95.0|-6.6|-0.6|||||For 95% CI of difference, normal approximation is used if N\>=5 in both arms. Otherwise exact method is used.|||-0.6|-6.6|
72391767|NCT00256750|144290853|SUPERIORITY_OR_OTHER||Difference in Percent|-0.5|||||TWO_SIDED|97.3|-6.5|5.3||||||Month 12||5.3|-6.5|
72454114|NCT00683800|144431783|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.05||||0.162|TWO_SIDED|95.0|-0.13|0.02|||Mixed Models Analysis|||For Week 12: Change from baseline of the GCS Sexual Dysfunction scale subscore was analyzed using a Mixed-effects model repeated measures (MMRM), for which changes from baseline at week 12, month 6, and month 12 were outcome variables, with treatment, week, and interaction between treatment and week as fixed effects with participant as a random effect, and with the baseline score as covariate.||0.02|-0.13|0.162
72499667|NCT01431287|144529536|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.017|STANDARD_ERROR_OF_MEAN|0.021||0.4374|TWO_SIDED|95.0|-0.025|0.059||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA|||||0.059|-0.025|0.4374
72391768|NCT00256750|144290853|SUPERIORITY_OR_OTHER||Difference in Percent|-0.9|||||TWO_SIDED|97.3|-6.9|4.8||||||||4.8|-6.9|
72562511|NCT03180801|144656519|OTHER||||||<|0.001|||||||t-test, 2 sided|||Comparison on day 63||||<0.001
72499668|NCT01431287|144529537|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.161|STANDARD_ERROR_OF_MEAN|0.043||0.0002|TWO_SIDED|95.0|0.077|0.244||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA|||||0.244|0.077|0.0002
72499669|NCT01431287|144529537|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.14|STANDARD_ERROR_OF_MEAN|0.045||0.0017|TWO_SIDED|95.0|0.053|0.228||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA|||||0.228|0.053|0.0017
72499670|NCT01431287|144529537|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.128|STANDARD_ERROR_OF_MEAN|0.042||0.0022|TWO_SIDED|95.0|0.046|0.21||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA|||||0.210|0.046|0.0022
72499671|NCT01431287|144529537|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.176|STANDARD_ERROR_OF_MEAN|0.042|<|0.0001|TWO_SIDED|95.0|0.093|0.259||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA|||||0.259|0.093|<0.0001
72499672|NCT01431287|144529537|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.108|STANDARD_ERROR_OF_MEAN|0.044||0.0141|TWO_SIDED|95.0|0.022|0.194||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA|||||0.194|0.022|0.0141
72499673|NCT01431287|144529537|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.032|STANDARD_ERROR_OF_MEAN|0.043||0.4581|TWO_SIDED|95.0|-0.053|0.118||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA|||||0.118|-0.053|0.4581
72499674|NCT01431287|144529537|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.208|STANDARD_ERROR_OF_MEAN|0.043|<|0.0001|TWO_SIDED|95.0|0.124|0.293||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA|||||0.293|0.124|<0.0001
72499675|NCT01431287|144529537|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.021|STANDARD_ERROR_OF_MEAN|0.043||0.6335|TWO_SIDED|95.0|-0.064|0.105||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA|||||0.105|-0.064|0.6335
72499676|NCT01431287|144529537|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.047|STANDARD_ERROR_OF_MEAN|0.041||0.253|TWO_SIDED|95.0|-0.129|0.034||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA|||||0.034|-0.129|0.2530
72499677|NCT01431287|144529537|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.068|STANDARD_ERROR_OF_MEAN|0.043||0.1188|TWO_SIDED|95.0|-0.017|0.153||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA|||||0.153|-0.017|0.1188
72499678|NCT01431287|144529538|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.137|STANDARD_ERROR_OF_MEAN|0.041||0.0008|TWO_SIDED|95.0|0.057|0.217||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA|||||0.217|0.057|0.0008
72499679|NCT01431287|144529538|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.126|STANDARD_ERROR_OF_MEAN|0.043||0.0032|TWO_SIDED|95.0|0.042|0.209||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA|||||0.209|0.042|0.0032
72499680|NCT01431287|144529538|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.105|STANDARD_ERROR_OF_MEAN|0.04||0.0085|TWO_SIDED|95.0|0.027|0.183||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA|||||0.183|0.027|0.0085
72499681|NCT01431287|144529538|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.156|STANDARD_ERROR_OF_MEAN|0.04||0.0001|TWO_SIDED|95.0|0.077|0.235||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA|||||0.235|0.077|0.0001
72499682|NCT01431287|144529538|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.094|STANDARD_ERROR_OF_MEAN|0.042||0.0255|TWO_SIDED|95.0|0.011|0.176||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA|||||0.176|0.011|0.0255
72499683|NCT01431287|144529538|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.032|STANDARD_ERROR_OF_MEAN|0.041||0.4393|TWO_SIDED|95.0|-0.049|0.113||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA|||||0.113|-0.049|0.4393
72499684|NCT01431287|144529538|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.188|STANDARD_ERROR_OF_MEAN|0.041|<|0.0001|TWO_SIDED|95.0|0.108|0.269||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA|||||0.269|0.108|<0.0001
72499685|NCT01431287|144529538|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.012|STANDARD_ERROR_OF_MEAN|0.041||0.7784|TWO_SIDED|95.0|-0.069|0.092||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA|||||0.092|-0.069|0.7784
72499686|NCT01431287|144529538|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.051|STANDARD_ERROR_OF_MEAN|0.039||0.1965|TWO_SIDED|95.0|-0.129|0.026||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA|||||0.026|-0.129|0.1965
72499687|NCT01431287|144529538|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.063|STANDARD_ERROR_OF_MEAN|0.041||0.1315|TWO_SIDED|95.0|-0.019|0.144||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA|||||0.144|-0.019|0.1315
72499688|NCT01431287|144529539|SUPERIORITY_OR_OTHER||Adjusted mean difference|-2.141|STANDARD_ERROR_OF_MEAN|0.56||0.0001|TWO_SIDED|95.0|-3.239|-1.043||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||-1.043|-3.239|0.0001
72499689|NCT01431287|144529539|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.131|STANDARD_ERROR_OF_MEAN|0.56||0.0435|TWO_SIDED|95.0|-2.23|-0.033||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||-0.033|-2.230|0.0435
72499690|NCT01431287|144529539|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.528|STANDARD_ERROR_OF_MEAN|0.559||0.0063|TWO_SIDED|95.0|-2.623|-0.432||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||-0.432|-2.623|0.0063
72499691|NCT01431287|144529539|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.517|STANDARD_ERROR_OF_MEAN|0.558||0.3545|TWO_SIDED|95.0|-1.611|0.577||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.577|-1.611|0.3545
72454115|NCT00683800|144431783|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.42|||<|0.001|TWO_SIDED|95.0|-1.84|-1.0|||Mixed Models Analysis|||For Week 12: Change from baseline of the GCS Psychological scale subscore was analyzed using a Mixed-effects model repeated measures (MMRM), for which changes from baseline at week 12, month 6, and month 12 was outcome variable, with treatment, week, and interaction between treatment and week as fixed effects with participant as a random effect, and with the baseline score as covariate.||-1.00|-1.84|<0.001
72454116|NCT00683800|144431783|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.22||||0.066|TWO_SIDED|95.0|-0.46|0.01|||Mixed Models Analysis|||For Week 12: Change from baseline of the GCS Somatic scale subscore was analyzed using a Mixed-effects model repeated measures (MMRM), for which changes from baseline at week 12, month 6, and month 12 were outcome variables, with treatment, week, and interaction between treatment and week as fixed effects with participant as a random effect, and with the baseline score as covariate.||0.01|-0.46|0.066
72454117|NCT00683800|144431783|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.64|||<|0.001|TWO_SIDED|95.0|-0.79|-0.5|||Mixed Models Analysis|||For Week 12: Change from baseline of the GCS Vasomotor scale subscore was analyzed using a Mixed-effects model repeated measures (MMRM), for which changes from baseline at week 12, month 6, and month 12 were outcome variables, with treatment, week, and interaction between treatment and week as fixed effects with participant as a random effect, and with the baseline score as covariate.||-0.50|-0.79|<0.001
72454118|NCT00683800|144431784|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.87|||<|0.001|TWO_SIDED|95.0|-2.57|-1.18|||Mixed Models Analysis|||For Month 6: Change from baseline of the GCS Total score was analyzed using a Mixed-effects model repeated measures (MMRM), for which changes from baseline at week 12, month 6, and month 12 were outcome variables, with treatment, week, and interaction between treatment and week as fixed effects with participant as a random effect, and with the baseline score as covariate.||-1.18|-2.57|<0.001
72454119|NCT00683800|144431784|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.65|||<|0.001|TWO_SIDED|95.0|-0.9|-0.41|||Mixed Models Analysis|||For Month 6: Change from baseline of the GCS Anxiety scale subscore was analyzed using a Mixed-effects model repeated measures (MMRM), for which changes from baseline at week 12, month 6, and month 12 were outcome variables, with treatment, week, and interaction between treatment and week as fixed effects with participant as a random effect, and with the baseline score as covariate.||-0.41|-0.90|<0.001
72454120|NCT00683800|144431784|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.58|||<|0.001|TWO_SIDED|95.0|-0.8|-0.37|||Mixed Models Analysis|||For Month 6: Change from baseline of the GCS Depression scale subscore was analyzed using a Mixed-effects model repeated measures (MMRM), for which changes from baseline at week 12, month 6, and month 12 were outcome variables, with treatment, week, and interaction between treatment and week as fixed effects with participant as a random effect, and with the baseline score as covariate.||-0.37|-0.80|<0.001
72454121|NCT00683800|144431784|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.04||||0.282|TWO_SIDED|95.0|-0.13|0.04|||Mixed Models Analysis|||For Month 6: Change from baseline of the GCS Sexual Dysfunction scale subscore was analyzed using a Mixed-effects model repeated measures (MMRM), for which changes from baseline at week 12, month 6, and month 12 were outcome variables, with treatment, week, and interaction between treatment and week as fixed effects with participant as a random effect, and with the baseline score as covariate.||0.04|-0.13|0.282
72454122|NCT00683800|144431784|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.24|||<|0.001|TWO_SIDED|95.0|-1.66|-0.82|||Mixed Models Analysis|||For Month 6: Change from baseline of the GCS Psychological scale subscore was analyzed using a Mixed-effects model repeated measures (MMRM), for which changes from baseline at week 12, month 6, and month 12 were outcome variables, with treatment, week, and interaction between treatment and week as fixed effects with participant as a random effect, and with the baseline score as covariate.||-0.82|-1.66|<0.001
72620257|NCT00159874|144771680|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-2.82|STANDARD_ERROR_OF_MEAN|6.01||0.64|TWO_SIDED|95.0|-14.75|9.11|||ANCOVA||Least square mean difference of -2.82 was calculated as ' Sildenafil High Dose - Medium Dose'|Analyses were performed using analysis of covariance with etiology, weight, day of assessment and baseline peak VO2 as the covariates.||9.11|-14.75|0.640
72454123|NCT00683800|144431784|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.17||||0.14|TWO_SIDED|95.0|-0.41|0.06|||Mixed Models Analysis|||For Month 6: Change from baseline of the GCS Somatic scale subscore was analyzed using a Mixed-effects model repeated measures (MMRM), for which changes from baseline at week 12, month 6, and month 12 were outcome variables, with treatment, week, and interaction between treatment and week as fixed effects with participant as a random effect, and with the baseline score as covariate.||0.06|-0.41|0.140
72454124|NCT00683800|144431784|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.41|||<|0.001|TWO_SIDED|95.0|-0.56|-0.26|||Mixed Models Analysis|||For Month 6: Change from baseline of the GCS Vasomotor scale subscore was analyzed using a Mixed-effects model repeated measures (MMRM), for which changes from baseline at week 12, month 6, and month 12 were outcome variables, with treatment, week, and interaction between treatment and week as fixed effects with participant as a random effect, and with the baseline score as covariate.||-0.26|-0.56|<0.001
72454125|NCT00683800|144431785|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.71|||<|0.001|TWO_SIDED|95.0|-2.42|-1.0|||Mixed Models Analysis|||For Month 12: Change from baseline of the GCS Total score was analyzed using a Mixed-effects model repeated measures (MMRM), for which changes from baseline at week 12, month 6 and month 12 were outcome variables, with treatment, week, and interaction between treatment and week as fixed effects with participant as a random effect, and with the baseline score as covariate.||-1.00|-2.42|<0.001
72499692|NCT01431287|144529539|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.518|STANDARD_ERROR_OF_MEAN|0.559||0.3542|TWO_SIDED|95.0|-1.614|0.578||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.578|-1.614|0.3542
72620258|NCT04019704|144771705|SUPERIORITY|||||||0.002|||||||Mixed Models Analysis|||||||0.002
72620259|NCT02662582|144771744|SUPERIORITY||LSMean difference|-12.0||||0.734|TWO_SIDED|90.0|-71.2|47.2||Statistical comparison was performed at a 2-sided 0.10 significance level.|Mixed Models Analysis|||Least square means (LSMeans), LSMean difference of CK-2127107 minus placebo, and 90% confidence intervals are based on a mixed effect model with treatment and period as fixed effects, subject as a random effect, and a compound symmetry covariance structure.||47.2|-71.2|0.734
72620260|NCT02662582|144771745|SUPERIORITY||LSMean Difference|-0.0219||||0.438|TWO_SIDED|90.0|-0.0694|0.0256||Statistical comparison was performed at a 2-sided 0.10 significance level.|Mixed Models Analysis|||Peak: LSMeans, LSMean difference of CK-2127107 minus placebo, and 90% confidence intervals are based on a mixed effect model with treatment and period as fixed effects, subject as a random effect, and a compound symmetry covariance structure.||0.0256|-0.0694|0.438
72620261|NCT02662582|144771745|SUPERIORITY||LSMean Difference|-0.0325||||0.114|TWO_SIDED|90.0|-0.0663|0.0014||Statistical comparison was performed at a 2-sided 0.10 significance level.|Mixed Models Analysis|||Isotime: LSMeans, LSMean difference of CK-2127107 minus placebo, and 90% confidence intervals are based on a mixed effect model with treatment and period as fixed effects, subject as a random effect, and a compound symmetry covariance structure.||0.0014|-0.0663|0.114
72620262|NCT02662582|144771746|SUPERIORITY||LSMean difference|0.75||||0.612|TWO_SIDED|90.0|-1.75|3.24||Statistical comparison was performed at a 2-sided 0.10 significance level.|Mixed Models Analysis|||Peak: LSMeans, LSMean difference of CK-2127107 minus placebo, and 90% confidence intervals are based on a mixed effect model with treatment and period as fixed effects, subject as a random effect, and a compound symmetry covariance structure.||3.24|-1.75|0.612
72391769|NCT00256750|144290855|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|0.5||||0.6573|TWO_SIDED|95.0|-1.6|2.6||Baseline observations were not used for imputations at subsequent time points.|ANOVA|ANOVA model: Component Score = treatment. Missing values were imputed using last observation carried forward (LOCF) method.|Statistical tests comparing each belatacept regimen to the CsA regimen were conducted at a significance level of 0.05. Subjects with only baseline observations were excluded from these summaries.|Mental Component Score; Month 6||2.6|-1.6|0.6573
72454126|NCT00683800|144431785|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.56|||<|0.001|TWO_SIDED|95.0|-0.81|-0.3|||Mixed Models Analysis|||For Month 12: Change from baseline of the GCS Anxiety scale subscore was analyzed using a Mixed-effects model repeated measures (MMRM), for which changes from baseline at week 12, month 6 and month 12 were outcome variables, with treatment, week, and interaction between treatment and week as fixed effects with participant as a random effect, and with the baseline score as covariate.||-0.30|-0.81|<0.001
72454127|NCT00683800|144431785|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.62|||<|0.001|TWO_SIDED|95.0|-0.83|-0.4|||Mixed Models Analysis|||For Month 12: Change from baseline of the GCS Depression scale subscore was analyzed using a Mixed-effects model repeated measures (MMRM), for which changes from baseline at week 12, month 6 and month 12 were outcome variables, with treatment, week, and interaction between treatment and week as fixed effects with participant as a random effect, and with the baseline score as covariate.||-0.40|-0.83|<0.001
72454128|NCT00683800|144431785|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.08||||0.082|TWO_SIDED|95.0|-0.17|0.01|||Mixed Models Analysis|||For Month 12: Change from baseline of the GCS Sexual Dysfunction scale subscore was analyzed using a Mixed-effects model repeated measures (MMRM), for which changes from baseline at week 12, month 6 and month 12 were outcome variables, with treatment, week, and interaction between treatment and week as fixed effects with participant as a random effect, and with the baseline score as covariate.||0.01|-0.17|0.082
72499693|NCT01431287|144529539|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.613|STANDARD_ERROR_OF_MEAN|0.556||0.2697|TWO_SIDED|95.0|-1.702|0.476||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.476|-1.702|0.2697
72499694|NCT01431287|144529539|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.13|STANDARD_ERROR_OF_MEAN|0.559||0.0434|TWO_SIDED|95.0|-2.227|-0.033||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||-0.033|-2.227|0.0434
72499695|NCT01431287|144529539|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.01|STANDARD_ERROR_OF_MEAN|0.563||0.0732|TWO_SIDED|95.0|-2.114|0.095||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.095|-2.114|0.0732
72499696|NCT01431287|144529539|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.011|STANDARD_ERROR_OF_MEAN|0.563||0.0724|TWO_SIDED|95.0|-2.114|0.092||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.092|-2.114|0.0724
72499697|NCT01431287|144529539|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.001|STANDARD_ERROR_OF_MEAN|0.563||0.9983|TWO_SIDED|95.0|-1.102|1.104||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||1.104|-1.102|0.9983
72499698|NCT01431287|144529540|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.852|STANDARD_ERROR_OF_MEAN|0.578||0.0014|TWO_SIDED|95.0|-2.985|-0.718||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||-0.718|-2.985|0.0014
72454129|NCT00683800|144431785|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.18|||<|0.001|TWO_SIDED|95.0|-1.61|-0.75|||Mixed Models Analysis|||For Month 12: Change from baseline of the GCS Psychological scale subscore was analyzed using a Mixed-effects model repeated measures (MMRM), for which changes from baseline at week 12, month 6 and month 12 were outcome variables, with treatment, week, and interaction between treatment and week as fixed effects with participant as a random effect, and with the baseline score as covariate.||-0.75|-1.61|<0.001
72620263|NCT02662582|144771746|SUPERIORITY||LSMean difference|0.29||||0.789|TWO_SIDED|90.0|-1.55|2.14||Statistical comparison was performed at a 2-sided 0.10 significance level.|Mixed Models Analysis|||Isotime: LSMeans, LSMean difference of CK-2127107 minus placebo, and 90% confidence intervals are based on a mixed effect model with treatment and period as fixed effects, subject as a random effect, and a compound symmetry covariance structure.||2.14|-1.55|0.789
72620264|NCT02662582|144771747|SUPERIORITY||LSMean difference|0.72||||0.225|TWO_SIDED|90.0|-0.26|1.7||Statistical comparison was performed at a 2-sided 0.10 significance level.|Mixed Models Analysis|||Peak: LSMeans, LSMean difference of CK-2127107 minus placebo, and 90% confidence intervals are based on a mixed effect model with treatment and period as fixed effects, subject as a random effect, and a compound symmetry covariance structure.||1.70|-0.26|0.225
72622473|NCT04903093|144774908|OTHER|The ratio and 90% CI were expressed as percentages.|Ratio (%) of adjusted geometric means|15.53|||||TWO_SIDED|90.0|12.46|19.36||||||Test: Famotidine 40 mg tablet + Abrocitinib 200 mg commercial tablet; Reference: Abrocitinib 200 mg commercial tablet||19.36|12.46|
72454130|NCT00683800|144431785|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.02||||0.865|TWO_SIDED|95.0|-0.25|0.21|||Mixed Models Analysis|||For Month 12: Change from baseline of the GCS Somatic scale subscore was analyzed using a Mixed-effects model repeated measures (MMRM), for which changes from baseline at week 12, month 6 and month 12 were outcome variables, with treatment, week, and interaction between treatment and week as fixed effects with participant as a random effect, and with the baseline score as covariate.||0.21|-0.25|0.865
72454131|NCT00683800|144431785|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.45|||<|0.001|TWO_SIDED|95.0|-0.61|-0.29|||Mixed Models Analysis|||For Month 12: Change from baseline of the GCS Vasomotor scale subscore was analyzed using a Mixed-effects model repeated measures (MMRM), for which changes from baseline at week 12, month 6 and month 12 were outcome variables, with treatment, week, and interaction between treatment and week as fixed effects with participant as a random effect, and with the baseline score as covariate.||-0.29|-0.61|<0.001
72454132|NCT00683800|144431786|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||A Cochran-Mantel-Haenszel row mean score test was used to compare the treatment groups.||||<0.001
72454133|NCT00683800|144431787|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||A Cochran-Mantel-Haenszel row mean score test was used to compare the treatment groups.||||<0.001
72454134|NCT00683800|144431788|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||A Cochran-Mantel-Haenszel row mean score test was used to compare the treatment groups.||||<0.001
72499699|NCT01431287|144529540|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.444|STANDARD_ERROR_OF_MEAN|0.576||0.4413|TWO_SIDED|95.0|-1.573|0.686||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.686|-1.573|0.4413
72499700|NCT01431287|144529540|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.437|STANDARD_ERROR_OF_MEAN|0.578||0.0129|TWO_SIDED|95.0|-2.569|-0.304||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||-0.304|-2.569|0.0129
72499701|NCT01431287|144529540|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.056|STANDARD_ERROR_OF_MEAN|0.574||0.9222|TWO_SIDED|95.0|-1.182|1.07||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||1.070|-1.182|0.9222
72499702|NCT01431287|144529540|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.029|STANDARD_ERROR_OF_MEAN|0.576||0.9602|TWO_SIDED|95.0|-1.157|1.1||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||1.100|-1.157|0.9602
72454135|NCT00683800|144431789|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||A Cochran-Mantel-Haenszel row mean score test was used to compare the treatment groups.||||<0.001
72454136|NCT00683800|144431790|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||A Cochran-Mantel-Haenszel row mean score test was used to compare the treatment groups.||||<0.001
72454137|NCT00683800|144431791|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||A Cochran-Mantel-Haenszel row mean score test was used to compare the treatment groups.||||<0.001
72499703|NCT01431287|144529540|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.415|STANDARD_ERROR_OF_MEAN|0.57||0.4669|TWO_SIDED|95.0|-1.533|0.703||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.703|-1.533|0.4669
72454138|NCT00683800|144431792|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||A Cochran-Mantel-Haenszel row mean score test was used to compare the treatment groups.||||<0.001
72454139|NCT00683800|144431793|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||A Cochran-Mantel-Haenszel row mean score test was used to compare the treatment groups.||||<0.001
72454140|NCT00683800|144431794|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||A Cochran-Mantel-Haenszel row mean score test was used to compare the treatment groups.||||<0.001
72454141|NCT00683800|144431795|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||A Cochran-Mantel-Haenszel row mean score test was used to compare the treatment groups.||||<0.001
72454142|NCT00683800|144431796|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||A Cochran-Mantel-Haenszel row mean score test was used to compare the treatment groups.||||<0.001
72454143|NCT00683800|144431797|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||A Cochran-Mantel-Haenszel row mean score test was used to compare the treatment groups.||||<0.001
72454144|NCT00683800|144431798|SUPERIORITY_OR_OTHER||Wald Formula|1.11|||||TWO_SIDED|90.0|-0.68|2.9|||||The 90% CI for excess risk is obtained using the Wald Formula.|Excess risk over placebo of DVS SR 100 mg per 1000 woman-years of exposure, defined as the difference in the exposure adjusted rates between the treatment groups, was obtained.||2.9|-0.68|
72562512|NCT02618382|144656528|SUPERIORITY||||||<|0.05||||||The P values for differences among time point means were determined by ANOVA for continuous variables|ANOVA|||Nonparametric tests were used for statistical comparison, including the Kruskal-Wallis rank-sum test for multiple groups and the Mann-Whitney U test for 2 groups. P values \<0.05 were considered statistically significant. Data tabulation and analysis were performed using R statistical software version 3.4.2 (R Foundation for Statistical Computing, Vienna, Austria).||||<0.05
72562513|NCT02618382|144656529|SUPERIORITY||||||<|0.05||||||Paired comparison of hematoma thickness at defined time point means determined by ANOVA for continuous variables.|ANOVA|||Nonparametric tests were used for statistical comparison, including the Kruskal-Wallis rank-sum test for multiple groups and the Mann-Whitney U test for 2 groups. P values \<0.05 were considered statistically significant. Data tabulation and analysis were performed using R statistical software version 3.4.2 (R Foundation for Statistical Computing, Vienna, Austria).||||<0.05
72562514|NCT02618382|144656530|OTHER||||||<|0.05||||||The P values for differences among time point means were determined by ANOVA for continuous variables and by chi-squared test for categorical values in grouped mRS scores.|ANOVA|||Nonparametric tests were used for statistical comparison, including the Kruskal-Wallis rank-sum test for multiple groups and the Mann-Whitney U test for 2 groups. P values \<0.05 were considered statistically significant. Data tabulation and analysis were performed using R statistical software version 3.4.2 (R Foundation for Statistical Computing, Vienna, Austria).||||<0.05
72562515|NCT00309985|144656531|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0003|TWO_SIDED||||||Log Rank|||The study was designed to detect a 33.3% improvement in median survival time across treatments with one-sided type I error of 0.025 and 80% power.||||0.0003
72562516|NCT00309985|144656532|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||Log Rank|||||||<0.0001
72620265|NCT02662582|144771747|SUPERIORITY||LSMean difference|0.92||||0.064||90.0|0.11|1.174||Statistical comparison was performed at a 2-sided 0.10 significance level.|Mixed Models Analysis|||Isotime: LSMeans, LSMean difference of CK-2127107 minus placebo, and 90% confidence intervals are based on a mixed effect model with treatment and period as fixed effects, subject as a random effect, and a compound symmetry covariance structure.||1.174|0.11|0.064
72620266|NCT02662582|144771748|SUPERIORITY||LSMean difference|0.052||||0.447|TWO_SIDED|90.0|-0.063|0.167||Statistical comparison was performed at a 2-sided 0.10 significance level.|Mixed Models Analysis|||LSMeans, LSMean difference of CK-2127107 minus placebo, and 90% confidence intervals are based on a mixed effect model with treatment and period as fixed effects, subject as a random effect, and a compound symmetry covariance structure.||0.167|-0.063|0.447
72454145|NCT00683800|144431800|SUPERIORITY_OR_OTHER||Wald Formula|2.31|||||TWO_SIDED|90.0|-2.08|6.71|||||The 90% CI for excess risk is obtained using the Wald Formula.|Excess risk over placebo of DVS SR 100 mg per 1000 woman-years of exposure, defined as the difference in the exposure adjusted rates between the treatment groups, was obtained.||6.71|-2.08|
72562517|NCT00309985|144656533|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||Log Rank|||||||<0.0001
72562518|NCT00309985|144656534|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||Fisher Exact|||||||<0.0001
72562519|NCT00309985|144656535|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||Fisher Exact|||||||<0.0001
72562520|NCT00309985|144656536|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0009|TWO_SIDED||||||Wilcoxon signed rank test|||||||0.0009
72562521|NCT00309985|144656536|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4|TWO_SIDED||||||Wilcoxon signed rank test|||||||0.40
72562522|NCT03110380|144656537|NON_INFERIORITY|A sample size of 260 participants per treatment group would provide at least 90% power to detect a non-inferiority margin of 4% in difference in percentage of participants with HIV-1 RNA ≥ 50 copies/mL at Week 48 between the two treatment groups. This was based on the assumptions that both treatment groups have 2% of participants with HIV-1 RNA ≥ 50 copies/mL at Week 48 (based on Gilead Genvoya and Stribild studies) and that the significance level of the test is at a one-sided 0.025 level.|Difference in Percentages|-0.7|||||TWO_SIDED|95.001|-2.8|1.0|||||The differences in percentages of participants between treatment groups and their 95.001% confidence intervals (CI) were calculated based on an unconditional exact method using 2 inverted 1-sided tests.|The null hypothesis was that the B/F/TAF group is at least 4% higher than the DTG + F/TAF group with respect to the percentage of participants with HIV-1 RNA ≥ 50 copies/mL as determined by the US FDA-defined snapshot algorithm at Week 48; the alternative hypothesis was that the B/F/TAF group is less than 4% higher than the DTG + F/TAF group with respect to the percentage of participants with HIV-1 RNA ≥ 50 copies/mL at Week 48.||1.0|-2.8|
72562523|NCT03110380|144656537|SUPERIORITY|||||||0.37|||||||Fisher Exact|||||||0.37
72562524|NCT03110380|144656538|NON_INFERIORITY|It would be concluded that B/F/TAF is noninferior to DTG+F/TAF if the lower bound of the 2-sided 95.001% CI of the difference between treatment groups (B/F/TAF group -DTG+F/TAF group) in the percentage of participants with HIV-1 RNA \< 50 copies/mL is greater than -10%.|Difference in Percentages|2.2|||||TWO_SIDED|95.001|-2.3|6.8|||||The differences in percentages of participants between treatment groups and their 95.001% CI were calculated based on an unconditional exact method using 2 inverted 1-sided tests.|||6.8|-2.3|
72562525|NCT03110380|144656539|SUPERIORITY||Difference in LSM|-18.0||||0.23|TWO_SIDED|95.0|-46.0|11.0|||ANOVA|P-value, difference in least squares means (LSM), and its 95% CI were from ANOVA model with treatment group as a fixed effect in the model.||||11|-46|0.23
72562526|NCT03173560|144656542|NON_INFERIORITY|Odd ratio for ORR24W was analyzed along with 90% CI for each treatment arm using Cochran-Mantel-Haenszel (CMH) method, stratified by Memorial Sloan-Kettering Cancer Center (MSKCC) prognostic group and prior programmed cell death protein 1/ programmed cell death protein ligand 1 (PD-1/PD-L1) treatment from IxRS data. Non-inferiority would be claimed if 1-sided P value is \<=0.045 at the final analysis for the non-inferiority test with the non-inferiority margin of the odd ratio =0.76.|Odds Ratio (OR)|0.88||||0.2676|TWO_SIDED|90.0|0.59|1.32|||Cochran-Mantel-Haenszel|||||1.32|0.59|0.2676
72562527|NCT03173560|144656543|SUPERIORITY|Percentage of participants with intolerable Grade 2 or any Grade \>=Grade 3 TEAEs within 24 weeks was tested using CMH method at 2-sided α=0.05, stratified by MSKCC prognostic group and prior PD-1/PD-L1 treatment from IxRS data. The treatment difference and 95% CI were also calculated based on asymptotic normal approximation.|Difference|3.2||||0.4763|TWO_SIDED|95.0|-5.5|11.9|||Cochran-Mantel-Haenszel|||||11.9|-5.5|0.4763
72454146|NCT00683800|144431801|SUPERIORITY_OR_OTHER||Wald Formula|0.08|||||TWO_SIDED|90.0|-3.51|3.67|||||The 90% CI for excess risk is obtained using the Wald Formula.|Excess risk over placebo of DVS SR 100 mg per 1000 woman-years of exposure, defined as the difference in the exposure adjusted rates between the treatment groups, was obtained.||3.67|-3.51|
72454147|NCT00229970|144431841|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.09||||0.022||95.0|0.01|0.16|||ANCOVA|The model included a factor for treatment and using the baseline Forced Expiratory Volume in One Second (FEV1) as a covariate.||||0.16|0.01|0.022
72454148|NCT00229970|144431841|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.17|||<|0.001||95.0|0.09|0.24|||ANCOVA|The model included a factor for treatment and using the baseline Forced Expiratory Volume in One Second (FEV1) as a covariate.||||0.24|0.09|<0.001
72454149|NCT01953692|144431852|SUPERIORITY||||||>|0.9999||||||one-sided p value|exact binomial distribution|||Comparison to a fixed efficacy target of 10%. H0: p ≤ 0.10 versus H1: p \> 0.10||||>0.9999
72454150|NCT01953692|144431853|SUPERIORITY||||||>|0.9999||||||one-sided p-value|exact binomial distribution|||Comparison to a fixed efficacy target of 25%. H0: p ≤ 0.25 versus H1: p \> 0.25||||>0.9999
72454151|NCT01953692|144431854|SUPERIORITY|||||||0.0306||||||one-sided p-value|exact binomial distribution|||Comparison to a fixed efficacy target of 10%. H0: p ≤ 0.10 versus H1: p \> 0.10||||0.0306
72499704|NCT01431287|144529540|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.471|STANDARD_ERROR_OF_MEAN|0.575||0.4126|TWO_SIDED|95.0|-1.598|0.656||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.656|-1.598|0.4126
72499705|NCT01431287|144529540|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.408|STANDARD_ERROR_OF_MEAN|0.583||0.0158|TWO_SIDED|95.0|-2.551|-0.265||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||-0.265|-2.551|0.0158
72499706|NCT01431287|144529540|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.381|STANDARD_ERROR_OF_MEAN|0.582||0.0177|TWO_SIDED|95.0|-2.521|-0.24||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||-0.240|-2.521|0.0177
72622474|NCT03555994|144774927|SUPERIORITY||Least square mean difference|-105.7||||0.023||90.0|-178.8|-32.6|||ANCOVA|||||-32.6|-178.8|0.023
72454152|NCT01953692|144431855|SUPERIORITY|||||||0.7696||||||one-sided p-value|exact binomial distribution|||Comparison to a fixed efficacy target of 25%. H0: p ≤ 0.25 versus H1: p \> 0.25||||0.7696
72499707|NCT01431287|144529540|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.027|STANDARD_ERROR_OF_MEAN|0.58||0.9624|TWO_SIDED|95.0|-1.164|1.109||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||1.109|-1.164|0.9624
72499708|NCT01431287|144529541|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.595|STANDARD_ERROR_OF_MEAN|0.136|<|0.0001|TWO_SIDED|95.0|0.329|0.862||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.862|0.329|<0.0001
72454153|NCT00853593|144431907|SUPERIORITY_OR_OTHER||One sample proportion|0.951|||||ONE_SIDED|95.0|0.906||||||The Model 4396 lead will be considered safe if the proportion of subjects free of Model 4396 lead-related complications at one month post-implant is greater than 80% (i.e. the one sided 95% lower confidence bound must be at least 80%).||||.906|
72454154|NCT00853593|144431908|SUPERIORITY_OR_OTHER||One sample mean|1.6|STANDARD_DEVIATION|1.4|||ONE_SIDED|95.0||1.8||||||||1.8||
72454155|NCT00853593|144431909|SUPERIORITY_OR_OTHER||One sample mean|2.3|STANDARD_DEVIATION|2.0|||ONE_SIDED|97.5||2.7||||||||2.7||
72454156|NCT00853593|144431910|SUPERIORITY_OR_OTHER||One sample proportion|0.927|||||TWO_SIDED|95.0|0.887|0.967||||||||.967|.887|
72454157|NCT00853593|144431911|SUPERIORITY_OR_OTHER||One sample proportion|0.969|||||TWO_SIDED|95.0|0.944|0.993||||||||.993|.944|
72454158|NCT00853593|144431912|SUPERIORITY_OR_OTHER||One sample proportion|0.959|||||TWO_SIDED|95.0|0.93|0.987||||||||.987|.930|
72454159|NCT00853593|144431913|SUPERIORITY_OR_OTHER||One sample proportion|0.948|||||TWO_SIDED|95.0|0.917|0.979||||||||.979|.917|
72454160|NCT00853593|144431919|SUPERIORITY_OR_OTHER||One sample mean|2.4|STANDARD_DEVIATION|1.9|||ONE_SIDED|95.0||2.7||||||||2.7||
72454161|NCT03758742|144431939|SUPERIORITY||||||<|0.0001|||||||Binomial Test|||||||<0.0001
72499709|NCT01431287|144529541|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.64|STANDARD_ERROR_OF_MEAN|0.136|<|0.0001|TWO_SIDED|95.0|0.373|0.907||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.907|0.373|<0.0001
72562528|NCT03173560|144656544|OTHER|The hazard ratio and the corresponding 90% CIs were estimated using the Cox regression model with Efron's method for ties, stratified by MSKCC prognostic group and prior PD-1/PD-L1 treatment.|Hazard Ratio (HR)|1.42|||||TWO_SIDED|90.0|1.08|1.86||||||||1.86|1.08|
72562529|NCT03173560|144656545|OTHER|Odd ratio for ORR was analyzed along with 90% CI for each treatment arm using CMH method stratified by MSKCC prognostic group and PD-1/PD-L1 treatment from IxRS data.|Odds Ratio (OR)|0.77|||||TWO_SIDED|90.0|0.52|1.14||||||||1.14|0.52|
72562530|NCT04254809|144656560|SUPERIORITY||Slope|-0.64|STANDARD_ERROR_OF_MEAN|0.19||0.001|TWO_SIDED|95.0|-1.02|-0.25||Threshold for statistical significance was p = .05|Regression, Linear||REST coded as 0, HSL coded as 1; negative slope reflects greater standardized reductions in outcome among REST compared to HSL|Intention to treat analyses carried last observation forward for all participants enrolled at baseline. Standardized residual change score calculated by regressing scores at one-week follow-up onto scores at baseline.||-0.25|-1.02|.001
72620267|NCT02662582|144771749|SUPERIORITY||LSMean difference|-0.8||||0.099|TWO_SIDED|90.0|-1.7|0.0||Statistical comparison was performed at a 2-sided 0.10 significance level.|Mixed Models Analysis|||Borg (Dyspnea) at Peak: LSMeans, LSMean difference of CK-2127107 minus placebo, and 90% confidence intervals are based on a mixed effect model with treatment and period as fixed effects, subject as a random effect, and a compound symmetry covariance structure.||0.0|-1.7|0.099
72454162|NCT05966155|144431973|SUPERIORITY||Mean Difference (Final Values)|-0.27||||0.677|TWO_SIDED|95.0|-1.54|1.0|||t-test, 2 sided|||||1.00|-1.54|0.677
72454163|NCT05966155|144431974|SUPERIORITY||Mean Difference (Final Values)|-0.6||||0.1264|TWO_SIDED|95.0|-1.4|0.2|||t-test, 2 sided|||||0.2|-1.4|0.1264
72454164|NCT05966155|144431975|SUPERIORITY||Mean Difference (Final Values)|0.3||||0.3692|TWO_SIDED|95.0|-0.4|1.1|||t-test, 2 sided||The by-group means and the estimated mean difference are independently rounded to the nearest tenth. As a result, the mean difference it not exactly equivalent to the difference in the two reported means.|||1.1|-0.4|0.3692
72454165|NCT05966155|144431976|SUPERIORITY|||||||0.8492|||||||Chi-squared|||||||0.8492
72454166|NCT05966155|144431977|SUPERIORITY|||||||0.0246|||||||Chi-squared|||||||0.0246
72454167|NCT05966155|144431978|SUPERIORITY|||||||0.0111|||||||Chi-squared|||||||0.0111
72454168|NCT05966155|144431979|SUPERIORITY|||||||0.0776|||||||Chi-squared|||||||0.0776
72454169|NCT05966155|144431980|SUPERIORITY|||||||0.0014|||||||Chi-squared|||||||0.0014
72454170|NCT06193590|144431984|SUPERIORITY|||||||0.21|||||||Wilcoxon (Mann-Whitney)|||||||0.21
72454171|NCT06193590|144431985|SUPERIORITY|||||||0.1|||||||Fisher Exact|||||||0.1
72499710|NCT01431287|144529541|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.423|STANDARD_ERROR_OF_MEAN|0.136||0.0019|TWO_SIDED|95.0|0.156|0.69||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.690|0.156|0.0019
72620268|NCT02662582|144771749|SUPERIORITY||LSMean difference|-0.5||||0.255|TWO_SIDED|90.0|-1.3|0.2||Statistical comparison was performed at a 2-sided 0.10 significance level.|Mixed Models Analysis|||Borg (Dyspnea) at isotime: LSMeans, LSMean difference of CK-2127107 minus placebo, and 90% confidence intervals are based on a mixed effect model with treatment and period as fixed effects, subject as a random effect, and a compound symmetry covariance structure.||0.2|-1.3|0.255
72454172|NCT06193590|144431987|SUPERIORITY|||||||0.001|||||||Fisher Exact|||||||0.001
72454173|NCT01706159|144431991|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.16||||0.3056||90.0|0.01|3.05||p-value was not adjusted for multiple comparisons.|Regression, Logistic|||A sample size of 90 subjects, with a 2:1 (active:placebo) randomization ratio, would ensure 80% power to detect a difference between active treatment and placebo at Week 8 with a 2-sided significance level of 10% based on a Fisher's exact test.||3.05|0.01|0.3056
72454174|NCT03775486|144432013|OTHER||Hazard Ratio (HR)|0.76||||0.074|TWO_SIDED|95.0|0.57|1.02|||Log Rank|||||1.02|0.57|0.074
72454175|NCT03775486|144432013|OTHER||Median|7.2|||||TWO_SIDED|95.0|5.3|7.9||||||Median progression-free survival (months)||7.9|5.3|
72454176|NCT03775486|144432013|OTHER||Median|5.3|||||TWO_SIDED|95.0|3.7|5.8||||||Median progression-free survival (months)||5.8|3.7|
72454177|NCT03775486|144432014|OTHER||Hazard Ratio (HR)|0.9||||0.604|TWO_SIDED|95.0|0.59|1.36|||Log Rank|||||1.36|0.59|0.604
72454178|NCT03775486|144432014|OTHER||Median|17.4|||||TWO_SIDED|95.0|14.1||NA = insufficient number of participants with events|||||Median overall survival (months)|||14.1|
72454179|NCT03775486|144432014|OTHER||Median overall survival (months)|11.8|||||TWO_SIDED|95.0|11.8||NA = insufficient number of participants with events||||The CI lower limit is included as the estimated value as there was an insufficient number of participants with events to calculate a median value|Median overall survival (months)|||11.8|
72454180|NCT03775486|144432016|OTHER|Median duration of response (months)|Median duration of response|6.5|||||TWO_SIDED|95.0|6.5||NA = insufficient number of participants with events||||The CI lower limit is included as the estimated value as there was an insufficient number of participants with events to calculate a median value||||6.5|
72454181|NCT03775486|144432016|OTHER|Median duration of response (months)|Median duration of response|3.8|||||TWO_SIDED|95.0|3.8||NA = insufficient number of participants with events||||The CI lower limit is included as the estimated value as there was an insufficient number of participants with events to calculate a median value||||3.8|
72454182|NCT03775486|144432017|OTHER||Hazard Ratio (HR)|0.46|||||TWO_SIDED|95.0|0.07|2.0||||||||2.00|0.07|
72454183|NCT03775486|144432017|OTHER||Median (months)|3.7|||||TWO_SIDED|95.0|1.7||NA = insufficient number of participants with events|||||Median progression-free survival (months)|||1.7|
72454184|NCT03775486|144432017|OTHER||Median (months)|3.7|||||TWO_SIDED|95.0|1.2|16.6||||||Median progression-free survival (months)||16.6|1.2|
72454185|NCT03775486|144432019|OTHER||Estimated difference in adjusted mean|-0.51|||||TWO_SIDED|95.0|-4.47|3.46||||||EORTC QLQ-LC13: Dyspnoea Estimated difference in adjusted mean change from baseline.||3.46|-4.47|
72454186|NCT03775486|144432019|OTHER||Estimated difference in adjusted mean|0.95|||||TWO_SIDED|95.0|-4.81|6.71||||||EORTC QLQ-LC13: Coughing Estimated difference in adjusted mean change from baseline.||6.71|-4.81|
72454187|NCT03775486|144432019|OTHER||Estimated difference in adjusted mean|-2.26|||||TWO_SIDED|95.0|-6.39|1.88||||||EORTC QLQ-LC13: Pain in chest Estimated difference in adjusted mean change from baseline.||1.88|-6.39|
72454188|NCT03775486|144432021|OTHER||Estimated difference in adjusted mean|1.64|||||TWO_SIDED|95.0|-2.2|5.47||||||EORTC QLQ-C30: Fatigue Estimated difference in adjusted mean change from baseline.||5.47|-2.20|
72454189|NCT03775486|144432021|OTHER||Estimated difference in adjusted mean|3.22|||||TWO_SIDED|95.0|-1.46|7.9||||||EORTC QLQ-C30: Appetite loss Estimated difference in adjusted mean change from baseline.||7.90|-1.46|
72454190|NCT04119063|144432025|OTHER|Paired t-tests comparing change in % difference following high vs low frequency gait training.||||||0.204|||||||t-test, 2 sided|||||||0.204
72454191|NCT04119063|144432026|OTHER|Paired t-test||||||0.049|||||||t-test, 2 sided|||||||0.049
72499711|NCT01431287|144529541|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.446|STANDARD_ERROR_OF_MEAN|0.136||0.0011|TWO_SIDED|95.0|0.179|0.712||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.712|0.179|0.0011
72499712|NCT01431287|144529541|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.468|STANDARD_ERROR_OF_MEAN|0.136||0.0006|TWO_SIDED|95.0|0.201|0.735||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.735|0.201|0.0006
72499713|NCT01431287|144529541|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.172|STANDARD_ERROR_OF_MEAN|0.136||0.2045|TWO_SIDED|95.0|-0.094|0.438||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.438|-0.094|0.2045
72499714|NCT01431287|144529541|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.618|STANDARD_ERROR_OF_MEAN|0.136|<|0.0001|TWO_SIDED|95.0|0.351|0.885||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.885|0.351|<0.0001
72499715|NCT01431287|144529541|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.045|STANDARD_ERROR_OF_MEAN|0.137||0.7432|TWO_SIDED|95.0|-0.313|0.223||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.223|-0.313|0.7432
72499716|NCT01431287|144529541|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.023|STANDARD_ERROR_OF_MEAN|0.136||0.8687|TWO_SIDED|95.0|-0.29|0.245||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.245|-0.290|0.8687
72562531|NCT04254809|144656561|SUPERIORITY||Slope|-0.61|STANDARD_ERROR_OF_MEAN|0.19||0.002|TWO_SIDED|95.0|-0.99|-0.23||Threshold for significance was p = .05|Regression, Linear||REST coded as 0, HSL coded as 1; negative slope reflects greater standardized reductions in outcome among REST compared to HSL|Intention to treat analyses carried last observation forward for all participants enrolled at baseline. Standardized residual change score calculated by regression scores at one-month follow-up onto scores at baseline.||-0.23|-0.99|.002
72562532|NCT04254809|144656562|SUPERIORITY||Slope|-0.45|STANDARD_ERROR_OF_MEAN|0.2||0.03|TWO_SIDED|95.0|-0.86|-0.05||Threshold for statistical significance was p = .05|Regression, Linear||REST coded as -, HSL coded as 1; negative slope reflects greater standardized reductions in outcome among REST compared to HSL.|Intention to treat analyses carried last observation forward for all participants enrolled at baseline. Standardized residual change score calculated by regression scores at one-week follow-up onto scores at baseline.||-.05|-0.86|.03
72454192|NCT04119063|144432027|OTHER|Paired t-tests comparing change in % difference following high vs low frequency gait training.||||||0.039|||||||t-test, 2 sided|||||||0.039
72454193|NCT04119063|144432028|OTHER|Paired t-tests comparing change in % difference following high vs low frequency gait training.||||||0.242|||||||t-test, 2 sided|||||||0.242
72499717|NCT01431287|144529541|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.022|STANDARD_ERROR_OF_MEAN|0.137||0.8709|TWO_SIDED|95.0|-0.29|0.246||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.246|-0.290|0.8709
72499718|NCT01431287|144529542|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.63|STANDARD_ERROR_OF_MEAN|0.137|<|0.0001|TWO_SIDED|95.0|0.362|0.898||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.898|0.362|<0.0001
72562533|NCT02795676|144656582|NON_INFERIORITY|Non-inferiority was to be declared if the lower bound of the confidence interval for the treatment difference is above the non-inferiority margin, which was met. No p-value was calculated as this is not relevant for non-inferiority.|Median Difference (Final Values)|-0.359|||||TWO_SIDED|95.0|-2.444|1.726|||Regression, Linear|The primary efficacy analysis compared eGFR slope between the treatment arms using a 2-stage model with quantile regression.||||1.726|-2.444|
72562534|NCT02690935|144656610|SUPERIORITY|||||||0.642||||||No adjustment of the p-value|t-test, 2 sided|||H0: The efficacy of 2LALERG and placebo are similar H1: The efficacy of 2LALERG and placebo are different||||0.642
72562535|NCT02690935|144656611|SUPERIORITY|||||||0.829||||||No adjustment for multiplicity|t-test, 2 sided|||H0: 2LALERG and placebo have the same effect on the quality of life H1: 2LALERG and placebo do not have the same effect on the quality of life||||0.829
72620269|NCT02662582|144771749|SUPERIORITY||LSMean difference|-0.2||||0.651|TWO_SIDED|90.0|-1.1|0.6||Statistical comparison was performed at a 2-sided 0.10 significance level.|Mixed Models Analysis|||Borg (Leg Effort) at Peak: LSMeans, LSMean difference of CK-2127107 minus placebo, and 90% confidence intervals are based on a mixed effect model with treatment and period as fixed effects, subject as a random effect, and a compound symmetry covariance structure.||0.6|-1.1|0.651
72622475|NCT03555994|144774928|SUPERIORITY||Least square mean difference|-25.87||||0.008||90.0|-40.88|-10.86|||ANCOVA|||||-10.86|-40.88|0.008
72454194|NCT04119063|144432029|OTHER|Paired t-tests comparing change in % difference following high vs low frequency gait training.||||||0.014|||||||t-test, 2 sided|||||||.014
72454195|NCT03683576|144432040|SUPERIORITY||Odds Ratio (OR)|0.674||||0.1425|TWO_SIDED|95.0|0.398|1.142|||Regression, Logistic||GB001 20 mg vs. Placebo|||1.142|0.398|0.1425
72454196|NCT03683576|144432040|SUPERIORITY||Odds Ratio (OR)|0.677||||0.1482|TWO_SIDED|95.0|0.399|1.149|||Regression, Logistic||GB001 40 mg vs. Placebo|||1.149|0.399|0.1482
72454197|NCT03683576|144432040|SUPERIORITY||Odds Ratio (OR)|0.651||||0.1086|TWO_SIDED|95.0|0.385|1.1|||Regression, Logistic||GB001 60 mg vs. Placebo|||1.100|0.385|0.1086
72622476|NCT03555994|144774929|SUPERIORITY||Least Square Mean difference|-21.99||||0.008||90.0|-34.55|-9.43|||ANCOVA|||||-9.43|-34.55|0.008
72499719|NCT01431287|144529542|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.434|STANDARD_ERROR_OF_MEAN|0.137||0.0015|TWO_SIDED|95.0|0.166|0.703||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.703|0.166|0.0015
72499720|NCT01431287|144529542|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.419|STANDARD_ERROR_OF_MEAN|0.137||0.0022|TWO_SIDED|95.0|0.151|0.687||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.687|0.151|0.0022
72562536|NCT04234464|144656701|SUPERIORITY||Mean Difference (Final Values)|13.51|||<|0.001|TWO_SIDED|95.0|10.09|16.94|||Mixed Models Analysis|||Maximum percentage fall in post-dose pre-exercise FEV₁ up to 60 minutes post-exercise challenge is analyzed using a mixed effects model adjusted for treatment, treatment period, treatment sequence as categorical fixed effects, period-specific pre-dose baseline FEV₁ and average pre-dose baseline FEV₁ as continuous covariates, and a random subject within treatment sequence effect.||16.94|10.09|<0.001
72562537|NCT04234464|144656702|SUPERIORITY||Odds Ratio (OR)|10.548|||<|0.001|TWO_SIDED|95.0|4.311|25.805|||Mixed Models Analysis|||A generalized linear mixed model with logit link adjusted for treatment, treatment period and treatment sequence as fixed effects, pre-dose baseline FEV₁ and average pre-dose baseline FEV₁ as continuous covariates, and a random subject within treatment sequence effect.||25.805|4.311|<0.001
72562538|NCT00373425|144656720|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.9||||0.3235|TWO_SIDED|95.0|0.741|1.104||If the primary analysis of DFS was not statistically significant, the hierarchical testing procedure would stop and all key secondary efficacy analyses would be nonsignificant; any further analysis of these outcomes would be considered exploratory.|Log Rank||Hazard ratio: erlotinib to placebo|The null hypothesis that DFS distributions of the 2 arms were equivalent was tested using an unstratified 2-sided log-rank test at the 0.05 level. The primary analysis of DFS was performed when at least 410 events had accrued. If the result of the primary analysis of DFS was statistically significant favoring the erlotinib treatment arm, the null hypothesis of no treatment difference of key secondary efficacy variables was tested under a hierarchical testing procedure.||1.104|0.741|0.3235
72562539|NCT00373425|144656725|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.94||||0.562|TWO_SIDED|95.0|0.78|1.144|||Log Rank|||The null hypothesis that DFS distributions of the 2 arms were equivalent was tested using an unstratified 2-sided log-rank test at the 0.05 level.||1.144|0.780|0.5620
72562540|NCT00551616|144656743|OTHER||% of observed pregnancies|1.78|||<|0.001|TWO_SIDED|95.0|1.04|2.98|||Chi-squared||Expected pregnancy rate = 5.58%|Comparison of % of observed pregnancies vs % of expected pregnancies based on Trussell 1998||2.98|1.04|<0.001
72562541|NCT00551616|144656743|OTHER||% of observed pregnancies|2.59|||<|0.001|TWO_SIDED|95.0|1.68|3.94|||Chi-squared||Expected pregnancy rate = 5.43%|Comparison of % of observed pregnancies vs % of expected pregnancies based on Trussell 1998||3.94|1.68|<0.001
72562542|NCT00243152|144656805|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||Visual analog scale (VAS) ratings in the scanner. Measures of pain ratings to evoked stimuli during scanning for heat applied to the affected side.||||<0.05
72562543|NCT00243152|144656805|SUPERIORITY||||||>|0.05|||||||t-test, 2 sided|||VAS rating in the scanner. Measures of pain rating to evoke stimuli during scanning for heat applied to the unaffected side.||||>0.05
72562544|NCT00243152|144656805|SUPERIORITY||||||>|0.05|||||||t-test, 2 sided|||VAS rating in the scanner. Measures of pain rating to evoke stimuli during scanning for cold applied to the affected side.||||>0.05
72562545|NCT00243152|144656805|SUPERIORITY||||||>|0.05|||||||t-test, 2 sided|||VAS rating in the scanner. Measures of pain rating to evoke stimuli during scanning for cold applied to the unaffected side.||||>0.05
72562546|NCT00243152|144656805|SUPERIORITY||||||>|0.05|||||||t-test, 2 sided|||VAS rating in the scanner. Measures of pain rating to evoke stimuli during scanning for brush applied to the affected side.||||>0.05
72620270|NCT02662582|144771749|SUPERIORITY||LSMean difference|-0.3||||0.591|TWO_SIDED|90.0|-1.0|0.5||Statistical comparison was performed at a 2-sided 0.10 significance level.|Mixed Models Analysis|||Borg (Leg Effort) at isotime: LSMeans, LSMean difference of CK-2127107 minus placebo, and 90% confidence intervals are based on a mixed effect model with treatment and period as fixed effects, subject as a random effect, and a compound symmetry covariance structure.||0.5|-1.0|0.591
72620271|NCT02662582|144771750|SUPERIORITY||LSMean difference|0.0286||||0.04|TWO_SIDED|90.0|0.0061|0.0511||Statistical comparison was performed at a 2-sided 0.10 significance level.|Mixed Models Analysis|||Peak: LSMeans, LSMean difference of CK-2127107 minus placebo, and 90% confidence intervals are based on a mixed effect model with treatment and period as fixed effects, subject as a random effect, and a compound symmetry covariance structure.||0.0511|0.0061|0.040
72562547|NCT00243152|144656805|SUPERIORITY||||||>|0.05|||||||t-test, 2 sided|||VAS rating in the scanner. Measures of pain rating to evoke stimuli during scanning for brush applied to the unaffected side.||||>0.05
72562548|NCT00401245|144656843|SUPERIORITY_OR_OTHER|||||||0.024||||||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|Chi-squared|||Overall comparison was made between each titration regimen and the control regimen (100 mg).||||0.024
72562549|NCT00401245|144656844|SUPERIORITY_OR_OTHER||||||<|0.001||||||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|ANOVA|||For DVS 50 mg QOD, analysis of variance (ANOVA) was used to compare the DESS score between each tapering regimen and the control regimen (no tapering) for the titration population, where treatment was kept as the factor.||||< 0.001
72562550|NCT00401245|144656844|SUPERIORITY_OR_OTHER||||||<|0.001||||||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|ANOVA|||For DVS 50/25 mg, ANOVA was used to compare the DESS score between each tapering regimen and the control regimen (no tapering) for the titration population, where treatment was kept as the factor.||||<0.001
72562551|NCT00401245|144656844|SUPERIORITY_OR_OTHER||||||<|0.001||||||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|ANOVA|||For DVS 50 mg/Placebo, ANOVA was used to compare the DESS score between each tapering regimen and the control regimen (no tapering) for the titration population, where treatment was kept as the factor.||||<0.001
72391770|NCT00256750|144290855|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|1.7||||0.1198|TWO_SIDED|95.0|-0.4|3.9||Baseline observations were not used for imputations at subsequent time points.|ANOVA|ANOVA model: Component Score = treatment. Missing values were imputed using last observation carried forward (LOCF) method.|Statistical tests comparing each belatacept regimen to the CsA regimen were conducted at a significance level of 0.05. Subjects with only baseline observations were excluded from these summaries.|Mental Component Score; Month 6||3.9|-0.4|0.1198
72391771|NCT00256750|144290855|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|1.5||||0.0672|TWO_SIDED|95.0|-0.1|3.2||Baseline observations were not used for imputations at subsequent time points.|ANOVA|ANOVA model: Component Score = treatment. Missing values were imputed using last observation carried forward (LOCF) method.|Statistical tests comparing each belatacept regimen to the CsA regimen were conducted at a significance level of 0.05. Subjects with only baseline observations were excluded from these summaries.|Physical Component Score; Month 6||3.2|-0.1|0.0672
72391772|NCT00256750|144290855|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|1.9||||0.0257|TWO_SIDED|95.0|0.2|3.6||Baseline observations were not used for imputations at subsequent time points.|ANOVA|ANOVA model: Component Score = treatment. Missing values were imputed using last observation carried forward (LOCF) method.|Statistical tests comparing each belatacept regimen to the CsA regimen were conducted at a significance level of 0.05. Subjects with only baseline observations were excluded from these summaries.|Physical Component Score; Month 6||3.6|0.2|0.0257
72391773|NCT00256750|144290855|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|0.8||||0.4146|TWO_SIDED|95.0|-1.2|2.9||Baseline observations were not used for imputations at subsequent time points.|ANOVA|ANOVA model: Component Score = treatment. Missing values were imputed using last observation carried forward (LOCF) method.|Statistical tests comparing each belatacept regimen to the CsA regimen were conducted at a significance level of 0.05. Subjects with only baseline observations were excluded from these summaries.|Mental Component Score; Month 12||2.9|-1.2|0.4146
72391774|NCT00256750|144290855|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|0.4||||0.7327|TWO_SIDED|95.0|-1.7|2.4||Baseline observations were not used for imputations at subsequent time points.|ANOVA|ANOVA model: Component Score = treatment. Missing values were imputed using last observation carried forward (LOCF) method.|Statistical tests comparing each belatacept regimen to the CsA regimen were conducted at a significance level of 0.05. Subjects with only baseline observations were excluded from these summaries.|Mental Component Score; Month 12||2.4|-1.7|0.7327
72391775|NCT00256750|144290855|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|2.1||||0.0144|TWO_SIDED|95.0|0.4|3.8||Baseline observations were not used for imputations at subsequent time points.|ANOVA|ANOVA model: Component Score = treatment. Missing values were imputed using last observation carried forward (LOCF) method.|Statistical tests comparing each belatacept regimen to the CsA regimen were conducted at a significance level of 0.05. Subjects with only baseline observations were excluded from these summaries.|Physical Component Score; Month 12||3.8|0.4|0.0144
72391776|NCT00256750|144290855|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|2.8||||0.0015|TWO_SIDED|95.0|1.1|4.5||Baseline observations were not used for imputations at subsequent time points.|ANOVA|ANOVA model: Component Score = treatment. Missing values were imputed using last observation carried forward (LOCF) method.|Statistical tests comparing each belatacept regimen to the CsA regimen were conducted at a significance level of 0.05. Subjects with only baseline observations were excluded from these summaries.|Physical Component Score; Month 12||4.5|1.1|0.0015
72391777|NCT00256750|144290855|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|1.3||||0.234|TWO_SIDED|95.0|-0.8|3.4||Baseline observations were not used for imputations at subsequent time points.|ANOVA|ANOVA model: Component Score = treatment. Missing values were imputed using last observation carried forward (LOCF) method.|Statistical tests comparing each belatacept regimen to the CsA regimen were conducted at a significance level of 0.05. Subjects with only baseline observations were excluded from these summaries.|Mental Component Score; Month 24||3.4|-0.8|0.2340
72391778|NCT00256750|144290855|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|0.5||||0.6635|TWO_SIDED|95.0|-1.7|2.6||Baseline observations were not used for imputations at subsequent time points.|ANOVA|ANOVA model: Component Score = treatment. Missing values were imputed using last observation carried forward (LOCF) method.|Statistical tests comparing each belatacept regimen to the CsA regimen were conducted at a significance level of 0.05. Subjects with only baseline observations were excluded from these summaries.|Mental Component Score; Month 24||2.6|-1.7|0.6635
72391779|NCT00256750|144290855|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|1.8||||0.0417|TWO_SIDED|95.0|0.1|3.5||Baseline observations were not used for imputations at subsequent time points.|ANOVA|ANOVA model: Component Score = treatment. Missing values were imputed using last observation carried forward (LOCF) method.|Statistical tests comparing each belatacept regimen to the CsA regimen were conducted at a significance level of 0.05. Subjects with only baseline observations were excluded from these summaries.|Physical Component Score; Month 24||3.5|0.1|0.0417
72391780|NCT00256750|144290855|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|2.7||||0.0026|TWO_SIDED|95.0|0.9|4.4||Baseline observations were not used for imputations at subsequent time points.|ANOVA|ANOVA model: Component Score = treatment. Missing values were imputed using last observation carried forward (LOCF) method.|Statistical tests comparing each belatacept regimen to the CsA regimen were conducted at a significance level of 0.05. Subjects with only baseline observations were excluded from these summaries.|Physical Component Score; Month 24||4.4|0.9|0.0026
72391781|NCT00256750|144290855|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|1.9||||0.0953|TWO_SIDED|95.0|-0.3|4.1||Baseline observations were not used for imputations at subsequent time points.|ANOVA|ANOVA model: Component Score = treatment. Missing values were imputed using last observation carried forward (LOCF) method.|Statistical tests comparing each belatacept regimen to the CsA regimen were conducted at a significance level of 0.05. Subjects with only baseline observations were excluded from these summaries.|Mental Component Score; Month 36||4.1|-0.3|0.0953
72454198|NCT03683576|144432041|SUPERIORITY||Mean Difference (Net)|-0.15||||0.1647|TWO_SIDED|95.0|-0.36|0.06|||ANCOVA||GB001 20 mg vs. Placebo|||0.06|-0.36|0.1647
72454199|NCT03683576|144432041|SUPERIORITY||Mean Difference (Net)|-0.15||||0.1737|TWO_SIDED|95.0|-0.37|0.07|||ANCOVA||GB001 40 mg vs. Placebo|||0.07|-0.37|0.1737
72622477|NCT03555994|144774930|SUPERIORITY||Least Square Mean difference|-35.06||||0.07||90.0|-66.54|-3.58|||ANCOVA|||||-3.58|-66.54|0.070
72622478|NCT03555994|144774930|SUPERIORITY||Least Square Mean difference|-11.72||||0.03||90.0|-20.13|-3.3|||ANCOVA|||||-3.30|-20.13|0.030
72562552|NCT00401245|144656845|SUPERIORITY_OR_OTHER|||||||0.092||||||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|ANOVA|||For DVS 50 mg QOD, ANOVA was used to compare the DESS score between each tapering regimen and the control regimen (no tapering) for the titration population, where treatment was kept as the factor||||0.092
72562553|NCT00401245|144656845|SUPERIORITY_OR_OTHER|||||||0.997||||||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|ANOVA|||For DVS 50/25 mg, ANOVA was used to compare the DESS score between each tapering regimen and the control regimen (no tapering) for the titration population, where treatment was kept as the factor||||0.997
72454200|NCT03683576|144432041|SUPERIORITY||Mean Difference (Net)|-0.19||||0.0879|TWO_SIDED|95.0|-0.4|0.03|||ANCOVA||GB001 60 mg vs. Placebo|||0.03|-0.40|0.0879
72454201|NCT03683576|144432042|SUPERIORITY||Mean Difference (Net)|0.016||||0.7718|TWO_SIDED|95.0|-0.091|0.123|||ANCOVA||GB001 20 mg vs. Placebo|||0.123|-0.091|0.7718
72454202|NCT03683576|144432042|SUPERIORITY||Mean Difference (Net)|0.041||||0.4562|TWO_SIDED|95.0|-0.067|0.149|||ANCOVA||GB001 40 mg vs. Placebo|||0.149|-0.067|0.4562
72454203|NCT03683576|144432042|SUPERIORITY||Mean Difference (Net)|0.075||||0.1631|TWO_SIDED|95.0|-0.03|0.18|||ANCOVA||GB001 60 mg vs. Placebo|||0.180|-0.030|0.1631
72454204|NCT03683576|144432043|SUPERIORITY||Hazard Ratio (HR)|0.719||||0.0466|TWO_SIDED|95.0|0.519|0.995|||Regression, Cox||GB001 20 mg vs. Placebo|||0.995|0.519|0.0466
72454205|NCT03683576|144432043|SUPERIORITY||Hazard Ratio (HR)|0.773||||0.1222|TWO_SIDED|95.0|0.558|1.071|||Regression, Cox||GB001 40 mg vs. Placebo|||1.071|0.558|0.1222
72454206|NCT03683576|144432043|SUPERIORITY||Hazard Ratio (HR)|0.698||||0.0304|TWO_SIDED|95.0|0.505|0.967|||Regression, Cox||GB001 60 mg vs. Placebo|||0.967|0.505|0.0304
72454207|NCT03683576|144432044|SUPERIORITY||Rate ratio|0.797||||0.3382|TWO_SIDED|95.0|0.501|1.268|||Negative binomial regression model||GB001 20 mg vs. Placebo|||1.268|0.501|0.3382
72454208|NCT03683576|144432044|SUPERIORITY||Rate ratio|0.748||||0.2248|TWO_SIDED|95.0|0.469|1.195|||Negative binomial regression model||GB001 40 mg vs. Placebo|||1.195|0.469|0.2248
72454209|NCT03683576|144432044|SUPERIORITY||Rate ratio|0.889||||0.609|TWO_SIDED|95.0|0.565|1.397|||Negative binomial regression model||GB001 60 mg vs. Placebo|||1.397|0.565|0.6090
72454210|NCT03683576|144432045|SUPERIORITY||Mean Difference (Net)|-0.023||||0.6645|TWO_SIDED|95.0|-0.127|0.081|||ANCOVA||GB001 20 mg vs. Placebo|||0.081|-0.127|0.6645
72454211|NCT03683576|144432045|SUPERIORITY||Mean Difference (Net)|0.035||||0.5288|TWO_SIDED|95.0|-0.074|0.144|||ANCOVA||GB001 40 mg vs. Placebo|||0.144|-0.074|0.5288
72454212|NCT03683576|144432045|SUPERIORITY||Mean Difference (Net)|0.079||||0.1362|TWO_SIDED|95.0|-0.025|0.182|||ANCOVA||GB001 60 mg vs. Placebo|||0.182|-0.025|0.1362
72454213|NCT03683576|144432046|SUPERIORITY||Mean Difference (Net)|6.122||||0.3957|TWO_SIDED|95.0|-8.007|20.251|||ANCOVA||GB001 20 mg vs. Placebo|||20.251|-8.007|0.3957
72454214|NCT03683576|144432046|SUPERIORITY||Mean Difference (Net)|13.948||||0.0598|TWO_SIDED|95.0|-0.578|28.474|||ANCOVA||GB001 40 mg vs. Placebo|||28.474|-0.578|0.0598
72454215|NCT03683576|144432046|SUPERIORITY||Mean Difference (Net)|5.588||||0.4376|TWO_SIDED|95.0|-8.522|19.698|||ANCOVA||GB001 60 mg vs. Placebo|||19.698|-8.522|0.4376
72454216|NCT04172675|144432110|SUPERIORITY||Hazard Ratio (HR)|0.28|||=|0.0007|TWO_SIDED|95.0|0.13|0.61|||Unstratified Log rank||Hazard ratio and 95% CI were estimated using a Cox proportional hazards regression model.|||0.61|0.13|=0.0007
72454217|NCT05349721|144432116|OTHER||Treatment Difference|6.86||||0.516|TWO_SIDED|95.0|-13.86|27.59|||ANCOVA|Estimates were derived from the ANCOVA model (following multiple imputation), where participant ranks served as the response variable.||||27.59|-13.86|0.516
72454218|NCT03070392|144432130|SUPERIORITY||Hazard Ratio (HR)|0.51|||<|0.0001|TWO_SIDED|95.0|0.37|0.71|||Log Rank|||||0.71|0.37|<0.0001
72454219|NCT03070392|144432132|SUPERIORITY||Hazard Ratio (HR)|0.73||||0.0139|TWO_SIDED|95.0|0.58|0.94|||Log Rank|||||0.94|0.58|0.0139
72454220|NCT03861052|144432148|SUPERIORITY||Least Squares Mean Difference|-1.09|||<|0.001|TWO_SIDED|95.0|-1.27|-0.9|||Mixed Models Analysis|||||-0.90|-1.27|<0.001
72454221|NCT03861052|144432148|SUPERIORITY||Least Squares Mean Difference|-1.27|||<|0.001|TWO_SIDED|95.0|-1.45|-1.08|||Mixed Models Analysis|||||-1.08|-1.45|<0.001
72454222|NCT03861052|144432148|SUPERIORITY||Least Squares Mean Difference|-1.53|||<|0.001|TWO_SIDED|95.0|-1.71|-1.35|||Mixed Models Analysis|||||-1.35|-1.71|<0.001
72454223|NCT03861052|144432149|SUPERIORITY||Odds Ratio (OR)|9.89|||<|0.001|TWO_SIDED|95.0|4.53|21.55|||Regression, Logistic|||||21.55|4.53|<0.001
72454224|NCT03861052|144432149|SUPERIORITY||Odds Ratio (OR)|20.57|||<|0.001|TWO_SIDED|95.0|7.73|54.71|||Regression, Logistic|||||54.71|7.73|<0.001
72454225|NCT03861052|144432149|SUPERIORITY||Odds Ratio (OR)|85.31|||<|0.001|TWO_SIDED|95.0|15.8|460.58|||Regression, Logistic|||||460.58|15.80|<0.001
72454226|NCT03861052|144432150|SUPERIORITY||Least Squares Mean Difference|-25.9|||<|0.001|TWO_SIDED|95.0|-30.7|-21.1|||Mixed Models Analysis|||||-21.1|-30.7|<0.001
72454227|NCT03861052|144432150|SUPERIORITY||Least Squares Mean Difference|-32.7|||<|0.001|TWO_SIDED|95.0|-37.5|-27.8|||Mixed Models Analysis|||||-27.8|-37.5|<0.001
72454228|NCT03861052|144432150|SUPERIORITY||Least Squares Mean Difference|-35.7|||<|0.001|TWO_SIDED|95.0|-40.6|30.9|||Mixed Models Analysis|||||30.9|-40.6|<0.001
72454229|NCT03861052|144432151|SUPERIORITY||Least Squares Mean Difference|-17.3|||<|0.001|TWO_SIDED|95.0|-21.4|-13.2|||ANCOVA|||||-13.2|-21.4|<0.001
72454230|NCT03861052|144432151|SUPERIORITY||Least Squares Mean Difference|-22.0|||<|0.001|TWO_SIDED|95.0|-26.1|-17.9|||ANCOVA|||||-17.9|-26.1|<0.001
72454231|NCT03861052|144432151|SUPERIORITY||Least Squares Mean Difference|-26.4|||<|0.001|TWO_SIDED|95.0|-30.5|-22.2|||ANCOVA|||||-22.2|-30.5|<0.001
72454232|NCT03861052|144432152|SUPERIORITY||Least Squares Mean Difference|-5.2|||<|0.001|TWO_SIDED|95.0|-6.4|-4.1|||Mixed Models Analysis|||||-4.1|-6.4|<0.001
72454233|NCT03861052|144432152|SUPERIORITY||Least Squares Mean Difference|-7.9|||<|0.001|TWO_SIDED|95.0|-9.1|-6.8|||Mixed Models Analysis|||||-6.8|-9.1|<0.001
72454234|NCT03861052|144432152|SUPERIORITY||Least Squares Mean Difference|-10.1|||<|0.001|TWO_SIDED|95.0|-11.3|-9.0|||Mixed Models Analysis|||||-9.0|-11.3|<0.001
72454235|NCT03861052|144432153|SUPERIORITY||Odds Ratio (OR)|14.44|||<|0.001|TWO_SIDED|95.0|7.88|26.46|||Regression, Logistic|||||26.46|7.88|<0.001
72454236|NCT03861052|144432153|SUPERIORITY||Odds Ratio (OR)|44.96|||<|0.001|TWO_SIDED|95.0|23.12|87.45|||Regression, Logistic|||||87.45|23.12|<0.001
72454237|NCT03861052|144432153|SUPERIORITY||Odds Ratio (OR)|82.67|||<|0.001|TWO_SIDED|95.0|39.84|171.52|||Regression, Logistic|||||171.52|39.84|<0.001
72562554|NCT00401245|144656845|SUPERIORITY_OR_OTHER|||||||0.009||||||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|ANOVA|||For DVS 50 mg/Placebo, ANOVA was used to compare the DESS score between each tapering regimen and the control regimen (no tapering) for the titration population, where treatment was kept as the factor||||0.009
72562555|NCT00401245|144656846|SUPERIORITY_OR_OTHER|||||||0.078|TWO_SIDED|||||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|ANOVA|||For DVS 50 mg QOD, ANOVA was used to compare the DESS score between each tapering regimen and the control regimen (no tapering) for the titration population, where treatment was kept as the factor.||||0.078
72562556|NCT00401245|144656846|SUPERIORITY_OR_OTHER|||||||0.005||95.0||||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|ANOVA|||For DVS 50/25 mg, ANOVA was used to compare the DESS score between each tapering regimen and the control regimen (no tapering) for the titration population, where treatment was kept as the factor.||||0.005
72562557|NCT00401245|144656846|SUPERIORITY_OR_OTHER|||||||0.929||95.0||||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|ANOVA|||For DVS 50mg/Placebo, ANOVA was used to compare the DESS score between each tapering regimen and the control regimen (no tapering) for the titration population, where treatment was kept as the factor.||||0.929
72562558|NCT00401245|144656848|SUPERIORITY_OR_OTHER|||||||0.017||||||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|Chi-squared|||Overall comparison was made between each titration regimen and the control regimen (100 mg).||||0.017
72562559|NCT00401245|144656855|SUPERIORITY_OR_OTHER||||||<|0.001||||||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|t-test, 2 sided|||Comparison was made between the difference in the means from the baseline value and post-baseline (Week 4) value with 0.||||<0.001
72562560|NCT00401245|144656855|SUPERIORITY_OR_OTHER||||||<|0.001||||||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|t-test, 2 sided|||Comparison was made between the difference in the means from the baseline value and post-baseline (Week 8) value with 0.||||< 0.001
72562561|NCT00401245|144656855|SUPERIORITY_OR_OTHER||||||<|0.001||||||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|t-test, 2 sided|||Comparison was made between the difference in the means from the base value and post-baseline (Week 12) value with 0.||||<0.001
72620272|NCT02662582|144771750|SUPERIORITY||LSMean differencce|0.0185||||0.155|TWO_SIDED|90.0|-0.0031|0.0401||Statistical comparison was performed at a 2-sided 0.10 significance level.|Mixed Models Analysis|||Isotime: LSMeans, LSMean difference of CK-2127107 minus placebo, and 90% confidence intervals are based on a mixed effect model with treatment and period as fixed effects, subject as a random effect, and a compound symmetry covariance structure.||0.0401|-0.0031|0.155
72620273|NCT02662582|144771751|SUPERIORITY||LSMean difference|0.001||||0.972|TWO_SIDED|90.0|-0.0459|0.0479||Statistical comparison was performed at a 2-sided 0.10 significance level.|Mixed Models Analysis|||Peak: LSMeans, LSMean difference of CK-2127107 minus placebo, and 90% confidence intervals are based on a mixed effect model with treatment and period as fixed effects, subject as a random effect, and a compound symmetry covariance structure.||0.0479|-0.0459|0.972
72454238|NCT03861052|144432154|SUPERIORITY||Least Squares Mean Difference|-2.47|STANDARD_ERROR_OF_MEAN|0.61|<|0.001|TWO_SIDED|95.0|-3.67|-1.28|||Mixed Models Analysis|||||-1.28|-3.67|<0.001
72454239|NCT03861052|144432154|SUPERIORITY||Least Squares Mean Difference|-3.27|STANDARD_ERROR_OF_MEAN|0.592|<|0.001|TWO_SIDED|95.0|-4.43|-2.11|||Mixed Models Analysis|||||-2.11|-4.43|<0.001
72454240|NCT03861052|144432154|SUPERIORITY||Least Squares Mean Difference|-3.4|STANDARD_ERROR_OF_MEAN|0.587|<|0.001|TWO_SIDED|95.0|-4.55|-2.25|||Mixed Models Analysis|||||-2.25|-4.55|<0.001
72454241|NCT03861052|144432155|SUPERIORITY||Least Squares Mean Difference|-0.26|STANDARD_ERROR_OF_MEAN|0.069|<|0.001|TWO_SIDED|95.0|-0.4|-0.13|||Mixed Models Analysis|||||-0.13|-0.40|<0.001
72454242|NCT03861052|144432155|SUPERIORITY||Least Squares Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.067|<|0.001|TWO_SIDED|95.0|-0.53|-0.27|||Mixed Models Analysis|||||-0.27|-0.53|<0.001
72454243|NCT03861052|144432155|SUPERIORITY||Least Squares Mean Difference|-0.38|STANDARD_ERROR_OF_MEAN|0.067|<|0.001|TWO_SIDED|95.0|-0.51|-0.25|||Mixed Models Analysis|||||-0.25|-0.51|<0.001
72454244|NCT03861052|144432156|SUPERIORITY||Least Squares Mean Difference|16.1|STANDARD_ERROR_OF_MEAN|2.72|<|0.001|TWO_SIDED|95.0|10.7|21.4|||Mixed Models Analysis|||||21.4|10.7|<0.001
72454245|NCT03861052|144432156|SUPERIORITY||Least Squares Mean Difference|20.6|STANDARD_ERROR_OF_MEAN|2.9|<|0.001|TWO_SIDED|95.0|14.9|26.3|||Mixed Models Analysis|||||26.3|14.9|<0.001
72454246|NCT03861052|144432156|SUPERIORITY||Least Squares Mean Difference|23.9|STANDARD_ERROR_OF_MEAN|2.95|<|0.001|TWO_SIDED|95.0|18.1|29.7|||Mixed Models Analysis|||||29.7|18.1|<0.001
72454247|NCT03861052|144432157|SUPERIORITY||Least Squares Mean Difference|19.9|STANDARD_ERROR_OF_MEAN|4.22|<|0.001|TWO_SIDED|95.0|11.7|28.2|||Mixed Models Analysis|||||28.2|11.7|<0.001
72454248|NCT03861052|144432157|SUPERIORITY||Least Squares Mean Difference|27.0|STANDARD_ERROR_OF_MEAN|4.59|<|0.001|TWO_SIDED|95.0|18.0|36.0|||Mixed Models Analysis|||||36.0|18.0|<0.001
72454249|NCT03861052|144432157|SUPERIORITY||Least Squares Mean Difference|31.2|STANDARD_ERROR_OF_MEAN|4.68|<|0.001|TWO_SIDED|95.0|22.0|40.4|||Mixed Models Analysis|||||40.4|22.0|<0.001
72454250|NCT02372799|144432200|SUPERIORITY||LSMD|-0.4||||0.7662|TWO_SIDED|95.0|-3.08|2.27|||MMRM|||||2.27|-3.08|0.7662
72454251|NCT02372799|144432200|SUPERIORITY||LSMD|-2.39||||0.1433|TWO_SIDED|95.0|-5.6|0.81|||MMRM|||||0.81|-5.60|0.1433
72454252|NCT02372799|144432201|SUPERIORITY||LSMD|-0.04||||0.7387|TWO_SIDED|95.0|-0.31|0.22|||MMRM|||||0.22|-0.31|0.7387
72454253|NCT02372799|144432201|SUPERIORITY||LSMD|-0.2||||0.2158|TWO_SIDED|95.0|-0.52|0.12|||MMRM|||||0.12|-0.52|0.2158
72454254|NCT00089609|144432209|SUPERIORITY_OR_OTHER|||||||0.02|||||||Wilcoxon (Mann-Whitney)|||||||.02
72454255|NCT03499964|144432229|SUPERIORITY||||||<|0.0001|||||||Chi-squared, Corrected|||||||<0.0001
72454256|NCT03499964|144432231|SUPERIORITY|||||||0.003|||||||t-test, 2 sided|||||||0.003
72562562|NCT00401245|144656855|SUPERIORITY_OR_OTHER||||||<|0.001||||||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|t-test, 2 sided|||Comparison was made between the difference in the means from the baseline value and post-baseline (Week 16) value with 0.||||<0.001
72454257|NCT02909959|144432233|EQUIVALENCE|Statistical significance was measured at the 0.05 alpha level for a two-sided test, so the rejection region for a normally distributed T-score was +/-1.96\*SE(Diff), where SE(Diff) is the estimated standard error of the difference between the LS mean of sulforaphane and LS mean of the placebo group.|Mean Difference (Final Values)|2.96|STANDARD_ERROR_OF_MEAN|3.03||0.331|TWO_SIDED|||||The test was considered statistically significant if the p-value \< 0.05.|Mixed Models Analysis|Mixed-effects model with random intercept and unstructured covariance matrix from baseline to week 16.|This analysis compares LS Mean Sulforaphane - LS Mean Placebo.|The null hypothesis is that the least-square mean of sulforaphane's SRS-2 T-score minus the least-square mean of placebo group's T-score is 0.||||0.331
72454258|NCT02909959|144432234|EQUIVALENCE|Statistical significance was measured at the 0.05 alpha level for a two-sided test, so the rejection region for a normally distributed T-score was +/-1.96\*SE(Diff), where SE(Diff) is the estimated standard error of the difference between the LS mean of sulforaphane and LS mean of the placebo group.|Mean Difference (Final Values)|0.08|STANDARD_ERROR_OF_MEAN|2.99||0.98|TWO_SIDED|||||The test was considered statistically significant if the p-value \< 0.05.|Mixed Models Analysis|Mixed-effects model with random intercept and unstructured covariance matrix from baseline to week 16.|This analysis compares LS Mean Sulforaphane - LS Mean Placebo.|The null hypothesis is that the least-square mean of sulforaphane's SRS-2 T-score minus the least-square mean of placebo group's T-score is 0.||||0.98
72454259|NCT02909959|144432235|EQUIVALENCE|Statistical significance was measured at the 0.05 alpha level for a two-sided test, so the rejection region for a normally distributed T-score was +/-1.96\*SE(Diff), where SE(Diff) is the estimated standard error of the difference between the LS mean of sulforaphane and LS mean of the placebo group.|Mean Difference (Final Values)|-0.774|STANDARD_ERROR_OF_MEAN|2.99||0.797|TWO_SIDED|||||The test was considered statistically significant if the p-value \< 0.05.|Mixed Models Analysis|Mixed-effects model with random intercept and unstructured covariance matrix from baseline to week 16.|This analysis compares LS Mean Sulforaphane - LS Mean Placebo.|The null hypothesis is that the least-square mean of sulforaphane's SRS-2 T-score minus the least-square mean of placebo group's T-score is 0.||||0.797
72454260|NCT02909959|144432236|EQUIVALENCE|Statistical significance was measured at the 0.05 alpha level for a two-sided test, so the rejection region for a normally distributed T-score was +/-1.96\*SE(Diff), where SE(Diff) is the estimated standard error of the difference between the LS mean of sulforaphane and LS mean of the placebo group.|Mean Difference (Final Values)|2.32|STANDARD_ERROR_OF_MEAN|3.01||0.442|TWO_SIDED|||||The test was considered statistically significant if the p-value \< 0.05.|Mixed Models Analysis|Mixed-effects model with random intercept and unstructured covariance matrix from baseline to week 16.|This analysis compares LS Mean Sulforaphane - LS Mean Placebo.|The null hypothesis is that the least-square mean of sulforaphane's SRS-2 T-score minus the least-square mean of placebo group's T-score is 0.||||0.442
72454261|NCT02909959|144432237|EQUIVALENCE|Statistical significance was measured at the 0.05 alpha level for a two-sided test, so the rejection region for a normally distributed T-score was +/-1.96\*SE(Diff), where SE(Diff) is the estimated standard error of the difference between the LS mean of sulforaphane and LS mean of the placebo group.|Mean Difference (Final Values)|2.72|STANDARD_ERROR_OF_MEAN|3.05||0.373|TWO_SIDED|||||The test was considered statistically significant if the p-value \< 0.05.|Mixed Models Analysis|Mixed-effects model with random intercept and unstructured covariance matrix from baseline to week 16.|This analysis compares LS Mean Sulforaphane - LS Mean Placebo.|The null hypothesis is that the least-square mean of sulforaphane's SRS-2 T-score minus the least-square mean of placebo group's T-score is 0.||||0.373
72454262|NCT00853580|144432280|SUPERIORITY|||||||0.51|||||||ANCOVA|||||||0.51
72454263|NCT00853580|144432281|SUPERIORITY|||||||0.33|||||||ANCOVA|||||||0.33
72454264|NCT00853580|144432282|SUPERIORITY|||||||0.86|||||||ANCOVA|||||||0.86
72454265|NCT00853580|144432283|SUPERIORITY|||||||0.04|||||||ANCOVA|||||||0.04
72454266|NCT00853580|144432284|SUPERIORITY|||||||0.33|||||||ANCOVA|||||||0.33
72454267|NCT00853580|144432285|SUPERIORITY|||||||0.99|||||||ANCOVA|||||||0.99
72454268|NCT00853580|144432286|SUPERIORITY|||||||0.9|||||||ANCOVA|||||||0.90
72620274|NCT02662582|144771751|SUPERIORITY||LSMean difference|-0.0118||||0.578|TWO_SIDED|90.0|-0.0471|0.0236||Statistical comparison was performed at a 2-sided 0.10 significance level.|Mixed Models Analysis|||Isotime: LSMeans, LSMean difference of CK-2127107 minus placebo, and 90% confidence intervals are based on a mixed effect model with treatment and period as fixed effects, subject as a random effect, and a compound symmetry covariance structure.||0.0236|-0.0471|0.578
72454269|NCT00853580|144432287|SUPERIORITY|||||||0.37|||||||ANCOVA|||||||0.37
72454270|NCT00853580|144432288|SUPERIORITY|||||||0.49|||||||ANCOVA|||||||0.49
72454271|NCT00853580|144432289|SUPERIORITY|||||||0.86|||||||ANCOVA|||||||0.86
72454272|NCT00853580|144432290|SUPERIORITY|||||||0.09|||||||ANCOVA|||||||0.09
72454273|NCT00853580|144432291|SUPERIORITY|||||||0.37|||||||ANCOVA|||||||0.37
72454274|NCT00853580|144432292|SUPERIORITY|||||||0.18|||||||ANCOVA|||||||0.18
72454275|NCT00853580|144432293|SUPERIORITY|||||||0.88|||||||ANCOVA|||||||0.88
72454276|NCT00853580|144432294|SUPERIORITY|||||||0.25|||||||ANCOVA|||||||0.25
72454277|NCT00853580|144432295|SUPERIORITY|||||||0.2|||||||ANCOVA|||||||0.20
72454278|NCT00853580|144432296|SUPERIORITY|||||||0.5|||||||ANCOVA|||||||0.50
72454279|NCT00853580|144432297|SUPERIORITY|||||||0.33|||||||ANCOVA|||||||0.33
72454280|NCT00853580|144432298|SUPERIORITY|||||||0.3|||||||ANCOVA|||||||0.30
72454281|NCT00853580|144432299|SUPERIORITY|||||||0.73|||||||ANCOVA|||||||0.73
72562563|NCT01989676|144656858|EQUIVALENCE|The hypothesis to be tested in this study was that the risk ratio of ORR of PF-05280014 versus that of trastuzumab-EU by Week 25 (+/-14 days) was within a pre-specified margin of 0.80 to 1.25.|Risk Ratio (RR)|0.94|||||TWO_SIDED|95.0|0.842|1.049||||||Risk Ratio and associated 95% confidence interval (CI) are unstratified and based on the Miettinen and Nurminen method.||1.049|0.842|
72454282|NCT01700205|144432300|OTHER|A priori power analyses determined that a sample size of 94 is required to detect a difference of 0.67 with 90% power and a 5% type 1 error rate. We conducted an intention-to-treat (ITT) analyses on the 113 infants using separate generalized estimating equations that included treatment group (CMF, EHF), time (infant age), and group × time interaction for each type of Z score (0.5-12.5 mos).|Slope|-0.018|||<|0.05|TWO_SIDED|95.0|-0.0363|-0.0002|||Generalized Estimating Equation|GEE analysis conducted with group (CMF, EHF), time (infant age, 0.5-12.5 months) and their interaction.||||-0.0002|-0.0363|<0.05
72454283|NCT01700205|144432301|OTHER|A priori power analyses determined that a sample size of 94 is required to detect a difference of 0.67 with 90% power and a 5% type 1 error rate. We conducted an intention-to-treat (ITT) analyses on the 113 infants using separate generalized estimating equations that included treatment group (CMF, EHF), time (infant age), and group × time interaction for each type of Z score (0.5-12.5 mos). We provide below the parameter estimates for WLZ scores only.|Slope|-0.023||||0.001|TWO_SIDED|95.0|-0.0362|-0.0093|||Generalized Estimating Equations|GEE analysis conducted on each type of Z score separately with group (CMF, EHF), time (infant age; 0.5-12.5 months) and their interaction.||||-0.0093|-0.0362|0.001
72454284|NCT01700205|144432302|OTHER|A priori power analyses determined that a sample size of 94 is required to detect a difference of 0.67 with 90% power and a 5% type 1 error rate. We conducted an intention-to-treat (ITT) analyses on the 113 infants using separate generalized estimating equations that included treatment group (CMF, EHF), time (infant age), and group × time interaction for each type of Z score (0.5-12.5 mos).|Slope|-0.02||||0.32|TWO_SIDED|95.0|-0.058|0.019|||Generalized Estimating Equation|GEE analysis conducted with group (CMF, EHF), time (infant age, 0.5-12.5 months) and their interaction||||0.019|-0.058|0.32
72454285|NCT01700205|144432303|OTHER|ANOVA with group (CMF, EHF) as between-subjects factor were conducted on intent-to-treat sample|||||<|0.05|||||||Repeated Measures ANOVA|We conducted a ANOVA with group (CMF, EHF) as between-subject factor.||ANOVAs were conducted with group (CMF, EHF) as the between-subjects factor.||||<0.05
72454286|NCT01700205|144432304|OTHER|ANOVA was conducted with group (CMF, EHF) as between-subjects factor on the intent-to-treat sample.||||||0.72|||||||Repeated Measure ANOVA|ANOVA was conducted with group (CMF, EHF) as between-subjects factor on the intent-to-treat sample.||Repeated Measures ANOVA conducted with group (CMF, EHF) as between-subjects factor||||0.72
72454287|NCT01700205|144432305|OTHER|Repeated Measures ANOVA conducted with group (CMF, EHF) as between-subjects factor on intent-to-treat sample||||||0.72|||||||Repeated Measure ANOVA|Repeated Measures ANOVA conducted with group (CMF, EHF) as between-subjects factor on intent-to-treat sample||Repeated Measures ANOVA conducted with group (CMF, EHF) as between-subjects factor on intent-to-treat sample||||0.72
72454288|NCT01700205|144432306|OTHER|Repeated Measures ANOVA conducted with group (CMF, EHF) as between-subjects factor on intent-to-treat sample||||||0.02|||||||Repeated Measure ANOVA|Repeated Measures ANOVA conducted with group (CMF, EHF) as between-subjects factor on intent-to-treat sample||Repeated Measures ANOVA conducted with group (CMF, EHF) as between-subjects factor on intent-to-treat sample||||0.02
72454289|NCT01728324|144432308|SUPERIORITY_OR_OTHER||Adjusted response rate|81.1|||<|0.0001|TWO_SIDED|95.0|76.34|85.87|||z-test|A stratified one sample z-test with 50% reference for PegIFN-ineligible and 71% for PegIFN-eligible patients was performed.|The adjusted response rate was tested against the historical control SVR rate of 68% (95% Confidence Interval (CI): 76.3, 85.9).|The proportion of patients achieving SVR12 achieved with 24 weeks of treatment with DBV/FDV/RBV in cirrhotic and non-cirrhotic patients was compared to an acceptable minimum SVR rate achieved with an approved direct acting anti-viral (DAA) in combination with PegIFN from historical data. The acceptable minimum SVR rate was an average of 71% (reference for PegIFN-eligible) and 50% (for PegIFN-ineligible patients), weighted by the sample size in each stratum.||85.87|76.34|<0.0001
72454290|NCT01728324|144432308|SUPERIORITY_OR_OTHER||Adjusted response rate|75.89||||0.002|TWO_SIDED|95.0|70.63|81.14|||z-test|A stratified one sample z-test with 50% reference for PegIFN-ineligible and 71% for PegIFN-eligible patients was performed.||The proportion of patients achieving SVR12 achieved with 16 weeks of treatment of non-cirrhotic and 24 weeks of treatment of cirrhotic patients was compared to an acceptable minimum SVR rate achieved with an approved direct acting anti-viral (DAA) in combination with PegIFN from historical data. The acceptable minimum SVR rate was an average of 71% (reference for PegIFN-eligible) and 50% (for PegIFN-ineligible patients), weighted by the sample size in each stratum.||81.14|70.63|0.0020
72454291|NCT01728324|144432309|SUPERIORITY_OR_OTHER||SVR12 Rates difference|6.4||||0.0532|TWO_SIDED|95.0|-1.4|14.2|||Koch's method|Adjusted for PegIFN eligibility using Koch's method, with continuity correction.||Koch's stratum-adjusted Mantel Haenszel methods were used to compare durations, adjusting for stratification factors.||14.2|-1.4|0.0532
72454292|NCT01728324|144432310|SUPERIORITY_OR_OTHER||SVR4 Rates difference|3.6||||0.1671|TWO_SIDED|95.0|-3.7|10.9|||Koch´s method|Adjusted for PegIFN eligibility using Koch´s method, with continuity correction.||Koch's stratum-adjusted Mantel Haenszel methods were used to compare durations, adjusting for stratification factors.||10.9|-3.7|0.1671
72454293|NCT01728324|144432311|SUPERIORITY_OR_OTHER||SVR24 Rates difference|-6.9||||0.0447|TWO_SIDED|95.0|-14.8|1.1|||Koch´s method|Adjusted for PegIFN eligibility using Koch´s method, with continuity correction.||Koch's stratum-adjusted Mantel Haenszel methods were used to compare durations, adjusting for stratification factors.||1.1|-14.8|0.0447
72499721|NCT01431287|144529542|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.227|STANDARD_ERROR_OF_MEAN|0.137||0.0966|TWO_SIDED|95.0|-0.041|0.495||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.495|-0.041|0.0966
72499722|NCT01431287|144529542|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.223|STANDARD_ERROR_OF_MEAN|0.137||0.1029|TWO_SIDED|95.0|-0.045|0.492||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.492|-0.045|0.1029
72454294|NCT03335488|144432321|SUPERIORITY||Odds Ratio (OR)|1.1||||1|TWO_SIDED|95.0|0.0|28.1|||Fisher Exact|||||28.1|0.0|1.0000
72562564|NCT01989676|144656859|SUPERIORITY||Cox Proportional Hazard|1.0||||0.505|TWO_SIDED|95.0|0.8|1.26||1-sided log-rank test was used to compare the PFS distribution between the two treatment groups and was stratified by prior trastuzumab exposure (Yes/No) and estrogen receptor (ER) status (ER positive vs. ER negative).|Log Rank||The 95% CI for the hazard ratio was based on the Cox's proportional hazard model.|||1.26|0.80|0.505
72562565|NCT01989676|144656860|SUPERIORITY||Cox Proportional Hazard|0.92||||0.304|TWO_SIDED|95.0|0.67|1.27||1-sided log-rank test was used to compare the DOR distribution between the two treatment groups and was stratified by prior trastuzumab exposure (Yes/No) and ER status (ER positive vs. ER negative).|Log Rank||The 95% CI for the hazard ratio was based on the Cox's proportional hazard model.|||1.27|0.67|0.304
72562566|NCT01989676|144656861|SUPERIORITY||Cox Proportional Hazard|0.929||||0.339|TWO_SIDED|95.0|0.656|1.316||1-sided log-rank test was used to compare the OS distribution between the two treatment groups and was stratified by prior trastuzumab exposure (Yes/No) and ER status (ER positive vs. ER negative).|Log Rank||The 95% CI for the hazard ratio was based on the Cox's proportional hazard model.|||1.316|0.656|0.339
72562567|NCT03941834|144656868|OTHER||Least square (LS) mean difference|0.7|||||TWO_SIDED|95.0|0.1|1.2||||||Analysis were performed using a mixed model with fixed effects for treatment, period and sequence; baseline NPRS as a covariate; and participant as a random effect.||1.2|0.1|
72562568|NCT03941834|144656873|OTHER||LS mean difference|2.4|||||TWO_SIDED|95.0|-6.8|11.5||||||Analysis was performed using a mixed model with fixed effects for treatment, period and sequence; baseline Penn-FPS-R as a covariate; and participant as a random effect.||11.5|-6.8|
72562569|NCT03941834|144656874|OTHER||LS Mean Difference|1.5|||||TWO_SIDED|95.0|-3.8|6.9||||||Analysis was performed using a mixed model with fixed effects for treatment, period and sequence; baseline pain disability index as a covariate; and participant as a random effect.||6.9|-3.8|
72562570|NCT03941834|144656875|OTHER||LS Mean Difference|-0.1|||||TWO_SIDED|95.0|-0.7|0.5||||||Analysis was performed using a mixed model with fixed effects for treatment, period and sequence; and participant as a random effect.||0.5|-0.7|
72562571|NCT03941834|144656876|OTHER||LS Mean Difference|0.7|||||TWO_SIDED|95.0|0.1|1.4||||||Analysis was performed using a mixed model with fixed effects for treatment, period and sequence; baseline NPRS as a covariate; and participant as a random effect.||1.4|0.1|
72562572|NCT03941834|144656877|OTHER||Odds Ratio (OR)|12.6|||||TWO_SIDED|95.0|0.7|229.6||||||Analysis was performed using a logistic regression model, including fixed effects for treatment, sequence, period and baseline NPRS score as a covariate.||229.6|0.7|
72562573|NCT01560819|144656885|SUPERIORITY_OR_OTHER_LEGACY|||||||0.03|||||||Wilcoxon signed rank test|||A power calculation was not done for this pilot study. Changes in PUCAI post-treatment were compared with baseline using the Wilcoxon signed rank test. P value \<0.05 was considered statistically significant.||||0.03
72562574|NCT02344745|144656886|SUPERIORITY_OR_OTHER|||||||0.08|||||||Wilcoxon (Mann-Whitney)|||||||0.08
72562575|NCT02344745|144656887|SUPERIORITY_OR_OTHER|||||||0.7|||||||Wilcoxon (Mann-Whitney)|||||||0.70
72562576|NCT02344745|144656888|SUPERIORITY_OR_OTHER|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||||||0.001
72562577|NCT02344745|144656889|SUPERIORITY_OR_OTHER|||||||0.5|||||||Wilcoxon (Mann-Whitney)|||||||0.50
72620275|NCT02662582|144771752|SUPERIORITY||LSMean difference|-0.65||||0.235|TWO_SIDED|90.0|-1.55|0.26||Statistical comparison was performed at a 2-sided 0.10 significance level.|Mixed Models Analysis|||Peak: LSMeans, LSMean difference of CK-2127107 minus placebo, and 90% confidence intervals are based on a mixed effect model with treatment and period as fixed effects, subject as a random effect, and a compound symmetry covariance structure.||0.26|-1.55|0.235
72454295|NCT03335488|144432323|SUPERIORITY|||||||0.8464|||||||Wilcoxon rank sum test|||Initial Treatment Period Week 1||||0.8464
72454296|NCT03335488|144432323|SUPERIORITY|||||||0.104|||||||Wilcoxon rank sum test|||Initial Treatment Period Week 2||||0.1040
72454297|NCT03335488|144432323|SUPERIORITY|||||||0.0979|||||||Wilcoxon rank sum test|||Initial Treatment Period Week 3||||0.0979
72454298|NCT03335488|144432323|SUPERIORITY|||||||0.9808|||||||Wilcoxon rank sum test|||End of Initial Treatment Period Week 4 - 0 Hr||||0.9808
72454299|NCT03335488|144432323|SUPERIORITY|||||||0.8329|||||||Wilcoxon rank sum test|||End of Initial Treatment Period Week 4 - 4 Hr||||0.8329
72454300|NCT03335488|144432323|SUPERIORITY|||||||0.2544|||||||Wilcoxon rank sum test|||End of Initial Treatment Period Week 4 - 8 Hr||||0.2544
72454301|NCT03335488|144432324|SUPERIORITY|||||||0.8579||||||P-value is from a t-test comparing log-transformed RAVICTI vs NaPBA values.|t-test|||||||0.8579
72562578|NCT02788513|144656890|OTHER|||||||0.9931||||||An alpha of 0.05 was used for one-sided test. The MCPMod procedure adjusts for multiplicity.|MCPMod Beta model fit.|Model assumption: 75% of max effect is achieved at 2 mg, 87.5% at 5 mg, 25% at 25 mg, max effect achieved at 10 mg of BI 425809, scalar parameter = 26||Multiple comparison procedures and modelling (MCPmod) techniques for mixed model repeated measures (MMRM) was used.||||0.9931
72562579|NCT02788513|144656890|OTHER|||||||0.9225||||||An alpha of 0.05 was used for one-sided test. The MCPMod procedure adjusts for multiplicity.|MCPMod Emax model fit.|Model assumption: 20% of the maximum effect is achieved at 2 mg||Multiple comparison procedures and modelling (MCPmod) techniques for mixed model repeated measures (MMRM) was used.||||0.9225
72562580|NCT02788513|144656890|OTHER|||||||0.9287||||||An alpha of 0.05 was used for one-sided test. The MCPMod procedure adjusts for multiplicity.|MCPMod Sigmoidal Emax model fit.|Model assumption: 25% of max effect achieved at 5 mg and 75% of max effect achieved at 10 mg of BI 425809.||Multiple comparison procedures and modelling (MCPmod) techniques for mixed model repeated measures (MMRM) was used.||||0.9287
72562581|NCT02788513|144656890|OTHER|||||||0.7646||||||An alpha of 0.05 was used for one-sided test. The MCPMod procedure adjusts for multiplicity.|MCPMod linear model fit.|No assumption needed.||Multiple comparison procedures and modelling (MCPmod) techniques for mixed model repeated measures (MMRM) was used.||||0.7646
72562582|NCT02788513|144656890|OTHER|||||||0.9335||||||An alpha of 0.05 was used for one-sided test. The MCPMod procedure adjusts for multiplicity.|MCPMod linear in log model fit.|No assumption needed.||Multiple comparison procedures and modelling (MCPmod) techniques for mixed model repeated measures (MMRM) was used.||||0.9335
72562583|NCT02788513|144656890|OTHER|||||||0.8199||||||An alpha of 0.05 was used for one-sided test. The MCPMod procedure adjusts for multiplicity.|MCPMod logistic model fit.|Model assumption: 10% of max effect achieved at 5 mg and 50% of max effect achieved at 10 mg of BI 425809.||Multiple comparison procedures and modelling (MCPmod) techniques for mixed model repeated measures (MMRM) was used.||||0.8199
72454302|NCT03335488|144432325|SUPERIORITY|||||||0.7155||||||P-value is from a t-test comparing log-transformed RAVICTI vs NaPBA values.|t-test|||||||0.7155
72454303|NCT00176202|144432335|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||Chi-squared|||||||<0.01
72562584|NCT02788513|144656890|OTHER||Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.58||0.934|TWO_SIDED|95.0|-1.09|1.18||p-values are nominal without multiplicity adjustment.|MMRM|MMRM information is described in the description section.||Mixed model repeated measures (MMRM)||1.18|-1.09|0.9340
72620276|NCT02662582|144771752|SUPERIORITY||LSMean differencce|-0.57||||0.215|TWO_SIDED|90.0|-1.33|0.19||Statistical comparison was performed at a 2-sided 0.10 significance level.|Mixed Models Analysis|||Isotime: LSMeans, LSMean difference of CK-2127107 minus placebo, and 90% confidence intervals are based on a mixed effect model with treatment and period as fixed effects, subject as a random effect, and a compound symmetry covariance structure.||0.19|-1.33|0.215
72454304|NCT00176202|144432335|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||Chi-squared|||||||<0.01
72620277|NCT02662582|144771753|SUPERIORITY||LSMean difference|0.7||||0.28|TWO_SIDED|90.0|-0.38|1.77||Statistical comparison was performed at a 2-sided 0.10 significance level.|Mixed Models Analysis|||Peak: LSMeans, LSMean difference of CK-2127107 minus placebo, and 90% confidence intervals are based on a mixed effect model with treatment and period as fixed effects, subject as a random effect, and a compound symmetry covariance structure.||1.77|-0.38|0.280
72620278|NCT02662582|144771753|SUPERIORITY||LSMean difference|0.46||||0.424|TWO_SIDED|90.0|-0.49|1.4||Statistical comparison was performed at a 2-sided 0.10 significance level.|Mixed Models Analysis|||Isotime: LSMeans, LSMean difference of CK-2127107 minus placebo, and 90% confidence intervals are based on a mixed effect model with treatment and period as fixed effects, subject as a random effect, and a compound symmetry covariance structure.||1.40|-0.49|0.424
72620279|NCT02662582|144771754|SUPERIORITY||LSMean difference|0.039||||0.187|TWO_SIDED|90.0|-0.0099|0.0879||Statistical comparison was performed at a 2-sided 0.10 significance level.|Mixed Models Analysis|||Peak: LSMeans, LSMean difference of CK-2127107 minus placebo, and 90% confidence intervals are based on a mixed effect model with treatment and period as fixed effects, subject as a random effect, and a compound symmetry covariance structure.||0.0879|-0.0099|0.187
72620280|NCT02662582|144771754|SUPERIORITY||LSMean difference|0.0488||||0.213|TWO_SIDED|90.0|-0.0163|0.114||Statistical comparison was performed at a 2-sided 0.10 significance level.|Mixed Models Analysis|||Isotime: LSMeans, LSMean difference of CK-2127107 minus placebo, and 90% confidence intervals are based on a mixed effect model with treatment and period as fixed effects, subject as a random effect, and a compound symmetry covariance structure.||0.1140|-0.0163|0.213
72454305|NCT00176202|144432336|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||Chi-squared|||||||<.01
72454306|NCT00176202|144432336|SUPERIORITY_OR_OTHER|||||||0.01|TWO_SIDED||||||Chi-squared|||||||0.01
72454307|NCT00176202|144432337|SUPERIORITY_OR_OTHER||effect size|-1.59|||<|0.01|TWO_SIDED|||||In case of both risperidone and divalproex sodium.|Chi-squared|||||||<0.01
72454308|NCT00176202|144432337|SUPERIORITY_OR_OTHER||Effect size|-1.33|||<|0.01|TWO_SIDED||||||Chi-squared|||||||<0.01
72454309|NCT00176202|144432338|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||Chi-squared|||baseline is compared to LOCF to determine the p value.||||<0.01
72454310|NCT00176202|144432338|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||Chi-squared|||||||<0.01
72454311|NCT03102034|144432375|OTHER||% vaccine recipients with solicited AEs|76.0|||||TWO_SIDED|90.0|56.0|90.0|||||Confidence intervals were Exact Clopper-Pearson.|||90|56|
72454312|NCT03102034|144432375|OTHER||% placebo recipients with solicited AEs|18.0|||||TWO_SIDED|90.0|3.0|47.0|||||Confidence intervals were Exact Clopper-Pearson.|||47|3|
72454313|NCT03102034|144432376|OTHER||% vaccinees with unsolicited AEs|24.0|||||TWO_SIDED|90.0|10.0|44.0|||||Confidence intervals were Exact Clopper-Pearson.|||44|10|
72454314|NCT03102034|144432376|OTHER||% placebo with unsolicited AEs|9.0|||||TWO_SIDED|90.0|0.0|36.0|||||Confidence intervals were Exact Clopper-Pearson.|||36|0|
72454315|NCT03102034|144432381|SUPERIORITY||||||<|0.001||||||Due to unequal sample sizes, a 1-sided Fisher's exact test was used to test the hypothesis that proportions of greater than or equal to 4-fold rises were higher in the vaccinated than in the placebo group. Statistical significance level was 0.05.|Fisher Exact|||||||<0.001
72562585|NCT02788513|144656890|OTHER||Median Difference (Final Values)|0.3|STANDARD_ERROR_OF_MEAN|0.58||0.6041|TWO_SIDED|95.0|-0.84|1.44||p-values are nominal without multiplicity adjustment.|MMRM|MMRM information is described in the description section.||Mixed model repeated measures (MMRM)||1.44|-0.84|0.6041
72454316|NCT03102034|144432382|SUPERIORITY||||||<|0.001||||||The threshold for statistical significance is 0.05.|Log Rank|||||||<0.001
72454317|NCT01701401|144432445|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||The p-value for the comparison of the LDV/SOF 12 week group against the adjusted historical null rate (60%) was based on a 2-sided 1-sample binomial test.|Binomial test|||||||<0.001
72454318|NCT01701401|144432445|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||The p-value for the comparison of the LDV/SOF+RBV 12 week group against the adjusted historical null rate (60%) was based on a 2-sided 1-sample binomial test.|Binomial test|||||||<0.001
72454319|NCT01701401|144432445|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||The p-value for the comparison of the LDV/SOF 24 week group against the adjusted historical null rate (60%) was based on a 2-sided 1-sample binomial test.|Binomial test|||||||<0.001
72454320|NCT01701401|144432445|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||The p-value for the comparison of the LDV/SOF+RBV 24 week group against the adjusted historical null rate (60%) was based on a 2-sided 1-sample binomial test.|Binomial test|||||||<0.001
72454321|NCT00989196|144432542|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|For the comparison of the PK profile of Human-cl rhFVIII with Kogenate, the 90% confidence intervals for the ratio or log-ratio of Human-cl rhFVIII over Kogenate for selected, dose independent or dose adjusted, PK parameters will be presented. In addition a formal statistical procedure will test whether the ratio of mean AUCs is within a 80 to 125% range to show bioequivalence.|Ratio|0.98|||||TWO_SIDED|90.0|0.874|1.107||||||||1.107|0.874|
72562586|NCT02788513|144656890|OTHER||Mean Difference (Final Values)|0.76|STANDARD_ERROR_OF_MEAN|0.58||0.1926|TWO_SIDED|95.0|-0.38|1.9||p-values are nominal without multiplicity adjustment.|MMRM|MMRM information is described in the description section.||Mixed model repeated measures (MMRM)||1.90|-0.38|0.1926
72454322|NCT01000805|144432551|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.62|||<|0.001|TWO_SIDED|95.0|-0.9|-0.33||This p-value is for the main effect of treatment.|Mixed Models Analysis|||||-0.33|-0.90|<0.001
72454323|NCT01000805|144432552|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.04|||<|0.001|TWO_SIDED|95.0|-5.83|-2.24|||Mixed Models Analysis|||||-2.24|-5.83|<0.001
72454324|NCT01000805|144432553|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.46||||0.112|TWO_SIDED|95.0|-1.03|0.11||This is the p-value for the Disrupt Work/School Work score.|Mixed Models Analysis|||||0.11|-1.03|0.112
72454325|NCT01000805|144432553|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.73||||0.005|TWO_SIDED|95.0|-1.24|-0.22||This the p-value for the Disrupt Social Life/Leisure score.|Mixed Models Analysis|||||-0.22|-1.24|0.005
72454326|NCT01000805|144432553|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.53||||0.04|TWO_SIDED|95.0|-1.04|-0.02||This is the p-value for the Disrupt Family Life/Home score.|Mixed Models Analysis|||||-0.02|-1.04|0.040
72454327|NCT01000805|144432553|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.75||||0.019|TWO_SIDED|95.0|-3.2|-0.29||P-value for the SDS Total score. First gated secondary outcome measure. Gatekeeper strategy controlled experiment-wise type I error for 5 secondary outcomes with stepwise comparisons of treatments until outcome failed to be significant (p\>0.05).|Mixed Models Analysis|||||-0.29|-3.20|0.019
72454328|NCT01000805|144432554|SUPERIORITY_OR_OTHER|||||||0.001||95.0||||This is the second gated secondary outcome measure. A gatekeeper strategy (Dmitrienko et al. 2003) controlled experiment-wise type I error for 5 secondary outcomes. Treatments were compared stepwise until an outcome failed to be significant (p\>0.05).|Cochran-Mantel-Haenszel|||||||0.001
72454329|NCT01000805|144432555|SUPERIORITY_OR_OTHER|||||||0.0082||95.0||||This is the third gated secondary outcome measure. A gatekeeper strategy (Dmitrienko et al. 2003) controlled experiment-wise type I error for 5 secondary outcomes. Treatments were compared stepwise until an outcome failed to be significant (p\>0.05).|Cochran-Mantel-Haenszel|||||||0.0082
72454330|NCT01000805|144432556|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.66|||<|0.001|TWO_SIDED|95.0|-5.2|-2.11||This is the fourth gated secondary outcome measure. A gatekeeper strategy (Dmitrienko et al. 2003) controlled experiment-wise type I error for 5 secondary outcomes. Treatments were compared stepwise until an outcome failed to be significant (p\>0.05).|Mixed Models Analysis|||||-2.11|-5.20|<0.001
72454331|NCT01000805|144432557|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.19||||0.001|TWO_SIDED|95.0|-3.5|-0.89||This is the fifth gated secondary outcome measure. A gatekeeper strategy (Dmitrienko et al. 2003) controlled experiment-wise type I error for 5 secondary outcomes. Treatments were compared stepwise until an outcome failed to be significant (p\>0.05).|Mixed Models Analysis|||||-0.89|-3.50|0.001
72499723|NCT01431287|144529542|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.211|STANDARD_ERROR_OF_MEAN|0.136||0.122|TWO_SIDED|95.0|-0.056|0.478||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.478|-0.056|0.1220
72499724|NCT01431287|144529542|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.438|STANDARD_ERROR_OF_MEAN|0.137||0.0014|TWO_SIDED|95.0|0.17|0.707||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.707|0.170|0.0014
72499725|NCT01431287|144529542|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.196|STANDARD_ERROR_OF_MEAN|0.137||0.1542|TWO_SIDED|95.0|-0.074|0.465||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.465|-0.074|0.1542
72562587|NCT02788513|144656890|OTHER||Median Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.58||0.9739|TWO_SIDED|95.0|-1.16|1.12||p-values are nominal without multiplicity adjustment.|MMRM|MMRM information is described in the description section.||Mixed model repeated measures (MMRM)||1.12|-1.16|0.9739
72562588|NCT02788513|144656891|OTHER||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.76||0.979|TWO_SIDED|95.0|-1.48|1.52||p-values are nominal without multiplicity adjustment.|ANCOVA|Analysis of Covariance model included baseline value for the secondary endpoint measure, MMSE stratification (\>=20, \<20) at baseline and treatment.||Analysis of Covariance (ANCOVA)||1.52|-1.48|0.979
72454332|NCT01000805|144432558|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.64|||<|0.001|TWO_SIDED|95.0|-0.97|-0.32||This is the p-value for the main effect of treatment for the BPI Severity for Worst Pain score. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|||||-0.32|-0.97|<0.001
72454333|NCT01000805|144432558|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.62|||<|0.001|TWO_SIDED|95.0|-0.9|-0.34||This is the p-value for main effect of treatment for the BPI Severity for Least Pain score. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|||||-0.34|-0.90|<0.001
72454334|NCT01000805|144432558|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.62|||<|0.001|TWO_SIDED|95.0|-0.9|-0.33||This is the p-value for the main effect of treatment for the BPI Severity for Average Pain score. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|||||-0.33|-0.90|<0.001
72454335|NCT01000805|144432558|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.74|||<|0.001|TWO_SIDED|95.0|-1.06|-0.42||This is the p-value for the main effect of treatment for the BPI Severity for Pain Right Now score. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|||||-0.42|-1.06|<0.001
72454336|NCT01000805|144432558|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.68|||<|0.001|TWO_SIDED|95.0|-1.03|-0.33||This is the p-value for the main effect of treatment for the BPI Pain Interference with General Activity score. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|||||-0.33|-1.03|<0.001
72454337|NCT01000805|144432558|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.73|||<|0.001|TWO_SIDED|95.0|-1.09|-0.37||This is the p-value for the main effect of treatment for the BPI Pain Interference with Mood score. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|||||-0.37|-1.09|<0.001
72454338|NCT01000805|144432558|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.45||||0.009|TWO_SIDED|95.0|-0.79|-0.11||This is the p-value for the main effect of treatment for the BPI Pain Interference with Walking Ability score. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|||||-0.11|-0.79|0.009
72454339|NCT01000805|144432558|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.56||||0.002|TWO_SIDED|95.0|-0.91|-0.21||This is the p-value for the main effect of treatment for the BPI Pain Interference with Normal Work score. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|||||-0.21|-0.91|0.002
72454340|NCT01000805|144432558|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7|||<|0.001|TWO_SIDED|95.0|-1.06|-0.35||This is the p-value for the main effect of treatment for the BPI Pain Interference with Relations with Others score. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|||||-0.35|-1.06|<0.001
72454341|NCT01000805|144432558|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.39||||0.042|TWO_SIDED|95.0|-0.76|-0.01||This is the p-value for the main effect of treatment for the BPI Pain Interference with Sleep score. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|||||-0.01|-0.76|0.042
72454342|NCT01000805|144432558|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.67|||<|0.001|TWO_SIDED|95.0|-1.03|-0.31||This is the p-value for the main effect of treatment for the BPI Pain Interference with Enjoyment of Life score. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|||||-0.31|-1.03|<0.001
72454343|NCT01000805|144432558|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.57|||<|0.001|TWO_SIDED|95.0|-0.88|-0.25||This is the p-value for the main effect of treatment for the BPI Mean Pain Interference score. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|||||-0.25|-0.88|<0.001
72454344|NCT01000805|144432559|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.48|||<|0.001|TWO_SIDED|95.0|-0.71|-0.26||P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|||||-0.26|-0.71|<0.001
72454345|NCT01000805|144432560|SUPERIORITY_OR_OTHER|||||||0.293||95.0||||This is the p-value for suicidal ideation. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|Fisher Exact|||||||0.293
72454346|NCT01000805|144432561|SUPERIORITY_OR_OTHER|||||||0.033||95.0||||P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|Fisher Exact|||||||0.033
72454347|NCT01000805|144432562|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.92|||<|0.001|TWO_SIDED|95.0|1.34|4.51||This is the p-value for the Change from Baseline at Week 8. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|||||4.51|1.34|<0.001
72454348|NCT01000805|144432562|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.4||||0.001|TWO_SIDED|95.0|0.97|3.83||This is the p-value for the Change up to Week 8. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|ANCOVA|||||3.83|0.97|0.001
72454349|NCT01000805|144432563|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.9||||0.083|TWO_SIDED|95.0|-0.25|4.04||This is the p-value for the Change from Baseline in SBP at Week 8. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|||||4.04|-0.25|0.083
72454350|NCT01000805|144432563|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.47||||0.513|TWO_SIDED|95.0|-0.95|1.9||This is the p-value for the Change from Baseline in DBP at Week 8. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|||||1.90|-0.95|0.513
72454351|NCT01000805|144432563|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.53||||0.124|TWO_SIDED|95.0|-0.42|3.47||This is the p-value for the Change from Baseline in SBP up to Week 8. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|ANCOVA|||||3.47|-0.42|0.124
72454352|NCT01000805|144432563|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.31||||0.638|TWO_SIDED|95.0|-0.98|1.6||This is the p-value for the Change from Baseline in DBP up to Week 8. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|ANCOVA|||||1.60|-0.98|0.638
72454353|NCT01000805|144432564|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.96|||<|0.001|TWO_SIDED|95.0|-1.37|-0.54||This is the p-value for the Change from Baseline at Week 8. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|||||-0.54|-1.37|<0.001
72454354|NCT01000805|144432564|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.88|||<|0.001|TWO_SIDED|95.0|-1.24|-0.51||This is the p-value for the Change from Baseline up to Week 8. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|ANCOVA|||||-0.51|-1.24|<0.001
72454355|NCT02823028|144432571|SUPERIORITY||Odds Ratio (OR)|0.931||||0.779|TWO_SIDED||||||Chi-squared|||||||.779
72454356|NCT02409680|144432572|SUPERIORITY||Risk Ratio (RR)|0.89||||0.012|TWO_SIDED|95.0|0.81|0.98||A-priori threshold for statistical significance at 0.05 was specified.|Cochran-Mantel-Haenszel|||The null hypothesis is there is no treatment effect on preterm delivery.||0.98|0.81|0.012
72454357|NCT02409680|144432573|SUPERIORITY||Risk Ratio (RR)|1.08||||0.299|TWO_SIDED|95.0|0.94|1.25|||Cochran-Mantel-Haenszel|||||1.25|0.94|0.299
72454358|NCT02409680|144432574|SUPERIORITY||Risk Ratio (RR)|0.95||||0.171|TWO_SIDED|95.0|0.9|1.01|||Cochran-Mantel-Haenszel|||||1.01|0.90|0.171
72454359|NCT02409680|144432575|SUPERIORITY||Risk Ratio (RR)|0.86||||0.048|TWO_SIDED|95.0|0.73|1.0|||Cochran-Mantel-Haenszel|||||1.00|0.73|0.048
72454360|NCT02409680|144432576|SUPERIORITY||Risk Ratio (RR)|0.87||||0.125|TWO_SIDED|95.0|0.73|1.04|||Cochran-Mantel-Haenszel|||||1.04|0.73|0.125
72454361|NCT02409680|144432577|SUPERIORITY||Risk Ratio (RR)|1.03||||0.9|TWO_SIDED|95.0|0.6|1.79|||Cochran-Mantel-Haenszel|||||1.79|0.60|0.900
72454362|NCT02409680|144432578|SUPERIORITY||Risk Ratio (RR)|1.25||||0.274|TWO_SIDED|95.0|0.84|1.86|||Cochran-Mantel-Haenszel|||||1.86|0.84|0.274
72499726|NCT01431287|144529542|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.192|STANDARD_ERROR_OF_MEAN|0.137||0.1626|TWO_SIDED|95.0|-0.077|0.461||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.461|-0.077|0.1626
72562589|NCT02788513|144656891|OTHER||Mean Difference (Final Values)|0.49|STANDARD_ERROR_OF_MEAN|0.77||0.521|TWO_SIDED|95.0|-1.01|2.0||p-values are nominal without multiplicity adjustment.|ANCOVA|Analysis of Covariance model included baseline value for the secondary endpoint measure, MMSE stratification (\>=20, \<20) at baseline and treatment.||Analysis of Covariance (ANCOVA)||2.00|-1.01|0.521
72454363|NCT02409680|144432579|SUPERIORITY||Risk Ratio (RR)|0.75||||0.512|TWO_SIDED|95.0|0.32|1.78|||Cochran-Mantel-Haenszel|||||1.78|0.32|0.512
72454364|NCT02409680|144432580|SUPERIORITY||Risk Ratio (RR)|0.77||||0.331|TWO_SIDED|95.0|0.45|1.31|||Cochran-Mantel-Haenszel|||||1.31|0.45|0.331
72454365|NCT02409680|144432582|SUPERIORITY||Risk Ratio (RR)|0.38||||0.015|TWO_SIDED|95.0|0.17|0.85|||Cochran-Mantel-Haenszel|||||0.85|0.17|0.015
72454366|NCT02409680|144432583|SUPERIORITY||Risk Ratio (RR)|0.75||||0.039|TWO_SIDED|95.0|0.61|0.93|||Cochran-Mantel-Haenszel|||||0.93|0.61|0.039
72499727|NCT01431287|144529542|SUPERIORITY_OR_OTHER||djusted mean difference|0.004|STANDARD_ERROR_OF_MEAN|0.138||0.9765|TWO_SIDED|95.0|-0.265|0.274||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.274|-0.265|0.9765
72620281|NCT02662582|144771755|SUPERIORITY||LSMean difference|-0.4||||0.64||90.0|-2.1|1.2||Statistical comparison was performed at a 2-sided 0.10 significance level.|Mixed Models Analysis|||Peak: LSMeans, LSMean difference of CK-2127107 minus placebo, and 90% confidence intervals are based on a mixed effect model with treatment and period as fixed effects, subject as a random effect, and a compound symmetry covariance structure.||1.2|-2.1|0.640
72620282|NCT02662582|144771755|SUPERIORITY||LSMean difference|-0.7||||0.487|TWO_SIDED|90.0|-2.5|1.1||Statistical comparison was performed at a 2-sided 0.10 significance level.|Mixed Models Analysis|||Isotime: LSMeans, LSMean difference of CK-2127107 minus placebo, and 90% confidence intervals are based on a mixed effect model with treatment and period as fixed effects, subject as a random effect, and a compound symmetry covariance structure.||1.1|-2.5|0.487
72620283|NCT02662582|144771756|SUPERIORITY||LSMean difference|0.095||||0.1|TWO_SIDED|90.0|0.0|0.189||Statistical comparison was performed at a 2-sided 0.10 significance level.|Mixed Models Analysis|||Peak: LSMeans, LSMean difference of CK-2127107 minus placebo, and 90% confidence intervals are based on a mixed effect model with treatment and period as fixed effects, subject as a random effect, and a compound symmetry covariance structure.||0.189|0.000|0.100
72620284|NCT02662582|144771756|SUPERIORITY||LSMean difference|0.133||||0.008|TWO_SIDED|90.0|0.053|0.213||Statistical comparison was performed at a 2-sided 0.10 significance level.|Mixed Models Analysis|||Isotime: LSMeans, LSMean difference of CK-2127107 minus placebo, and 90% confidence intervals are based on a mixed effect model with treatment and period as fixed effects, subject as a random effect, and a compound symmetry covariance structure.||0.213|0.053|0.008
72499728|NCT01431287|144529543|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.647|STANDARD_ERROR_OF_MEAN|0.142|<|0.0001|TWO_SIDED|95.0|0.37|0.925||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.925|0.370|<0.0001
72499729|NCT01431287|144529543|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.322|STANDARD_ERROR_OF_MEAN|0.141||0.0226|TWO_SIDED|95.0|0.045|0.6||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.600|0.045|0.0226
72454367|NCT02409680|144432584|SUPERIORITY||Risk Ratio (RR)|0.93||||0.073|TWO_SIDED|95.0|0.87|1.01|||Cochran-Mantel-Haenszel|||||1.01|0.87|0.073
72454368|NCT02409680|144432585|SUPERIORITY||Risk Ratio (RR)|0.87||||0.084|TWO_SIDED|95.0|0.57|1.33|||Cochran-Mantel-Haenszel|||||1.33|0.57|0.084
72454369|NCT02409680|144432586|SUPERIORITY||Risk Ratio (RR)|0.86||||0.039|TWO_SIDED|95.0|0.73|1.0|||Cochran-Mantel-Haenszel|||||1.00|0.73|0.039
72454370|NCT02409680|144432587|SUPERIORITY||Risk Ratio (RR)|0.88||||0.261|TWO_SIDED|95.0|0.7|1.1|||Cochran-Mantel-Haenszel|||||1.10|0.70|0.261
72454371|NCT02409680|144432588|SUPERIORITY||Risk Ratio (RR)|0.85||||0.141|TWO_SIDED|95.0|0.68|1.06|||Cochran-Mantel-Haenszel|||||1.06|0.68|0.141
72454372|NCT02409680|144432589|SUPERIORITY||Risk Ratio (RR)|1.4||||0.157|TWO_SIDED|95.0|0.88|2.23|||Cochran-Mantel-Haenszel|||||2.23|0.88|0.157
72454373|NCT05200416|144432619|SUPERIORITY||Mean Difference (Final Values)|11.42|||<|0.001|TWO_SIDED|95.0|7.83|15.01|||Mixed Models Analysis|||||15.01|7.83|<0.001
72454374|NCT05200416|144432620|SUPERIORITY||Mean Difference (Final Values)|-4.16||||0.001|TWO_SIDED|95.0|-6.69|-1.63|||Mixed Models Analysis|||||-1.63|-6.69|0.001
72454375|NCT05986617|144432621|SUPERIORITY|||||||0.06429||||||2-tail t-test with non-equivalent variances|t-test, 2 sided|||Power calculation: 2 factor (group, time) ANOVA design with a group\*time interaction term to estimate the proposed sample size. Using a Cohen's effect size estimate for 2 groups with 5 time-points, a sample size of 40 per group will provide \>90% to detect a moderate effect size (0.25) for group, for time and for the group\*time interaction.||||.06429
72562590|NCT02788513|144656891|OTHER||Mean Difference (Final Values)|-1.53|STANDARD_ERROR_OF_MEAN|0.77||0.047|TWO_SIDED|95.0|-3.04|-0.02||p-values are nominal without multiplicity adjustment.|ANCOVA|Analysis of Covariance model included baseline value for the secondary endpoint measure, MMSE stratification (\>=20, \<20) at baseline and treatment.||Analysis of Covariance (ANCOVA)||-0.02|-3.04|0.047
72620285|NCT02662582|144771757|SUPERIORITY||LSMean difference|0.051||||0.408|TWO_SIDED|90.0|-0.052|0.154||Statistical comparison was performed at a 2-sided 0.10 significance level.|Mixed Models Analysis|||Peak: LSMeans, LSMean difference of CK-2127107 minus placebo, and 90% confidence intervals are based on a mixed effect model with treatment and period as fixed effects, subject as a random effect, and a compound symmetry covariance structure.||0.154|-0.052|0.408
72620286|NCT02662582|144771757|SUPERIORITY||LSMean difference|0.094||||0.058|TWO_SIDED|90.0|0.013|0.174||Statistical comparison was performed at a 2-sided 0.10 significance level.|Mixed Models Analysis|||Isotime: LSMeans, LSMean difference of CK-2127107 minus placebo, and 90% confidence intervals are based on a mixed effect model with treatment and period as fixed effects, subject as a random effect, and a compound symmetry covariance structure.||0.174|0.013|0.058
72620287|NCT02662582|144771758|SUPERIORITY||LSMean difference|1.44||||0.648|TWO_SIDED|90.0|-3.85|6.73||Statistical comparison was performed at a 2-sided 0.10 significance level.|Mixed Models Analysis|||Peak: LSMeans, LSMean difference of CK-2127107 minus placebo, and 90% confidence intervals are based on a mixed effect model with treatment and period as fixed effects, subject as a random effect, and a compound symmetry covariance structure.||6.73|-3.85|0.648
72620288|NCT02662582|144771758|SUPERIORITY||LSMean difference|0.85||||0.775|TWO_SIDED|90.0|-4.12|5.82||Statistical comparison was performed at a 2-sided 0.10 significance level.|Mixed Models Analysis|||Isotime: LSMeans, LSMean difference of CK-2127107 minus placebo, and 90% confidence intervals are based on a mixed effect model with treatment and period as fixed effects, subject as a random effect, and a compound symmetry covariance structure.||5.82|-4.12|0.775
72620289|NCT02662582|144771759|SUPERIORITY||LSMean difference|1.1||||0.544|TWO_SIDED|90.0|-1.9|4.0||Statistical comparison was performed at a 2-sided 0.10 significance level.|Mixed Models Analysis|||Peak: LSMeans, LSMean difference of CK-2127107 minus placebo, and 90% confidence intervals are based on a mixed effect model with treatment and period as fixed effects, subject as a random effect, and a compound symmetry covariance structure.||4.0|-1.9|0.544
72620290|NCT02662582|144771759|SUPERIORITY||LSMean difference|2.1||||0.216|TWO_SIDED|90.0|-0.7|5.0||Statistical comparison was performed at a 2-sided 0.10 significance level.|Mixed Models Analysis|||Isotime: LSMeans, LSMean difference of CK-2127107 minus placebo, and 90% confidence intervals are based on a mixed effect model with treatment and period as fixed effects, subject as a random effect, and a compound symmetry covariance structure.||5.0|-0.7|0.216
72620291|NCT02662582|144771760|SUPERIORITY||LSMean difference|-7.4||||0.171|TWO_SIDED|90.0|-16.5|1.6||Statistical comparison was performed at a 2-sided 0.10 significance level.|Mixed Models Analysis|||Peak: LSMeans, LSMean difference of CK-2127107 minus placebo, and 90% confidence intervals are based on a mixed effect model with treatment and period as fixed effects, subject as a random effect, and a compound symmetry covariance structure.||1.6|-16.5|0.171
72454376|NCT03789656|144432624|OTHER|||||||0.6285|||||||Wilcoxon Signed Rank test|||The primary efficacy endpoint was completed with the Efficacy Analysis Set (EAS), which included all treated subjects in Group 1. The median (Interquartile range) for change from baseline in IGF-1xULN to Week 13/EoT and p-value from the Wilcoxon signed rank test were presented. Baseline was defined as the mean of all IGF-1xULN values prior to first dose. Last on treatment assessment was used for EoT if subject discontinued before Week 13.||||0.6285
72454377|NCT03789656|144432625|OTHER|||||||0.3877|||||||exact binomial test assuming the null pr|Null proportion = 0.5||||||0.3877
72454378|NCT06214052|144432655|OTHER||Emax|-2.69|STANDARD_ERROR_OF_MEAN|5.0||||||||||||||||
72620292|NCT02662582|144771760|SUPERIORITY||LSMean difference|0.2||||0.976|TWO_SIDED|90.0|-10.3|10.7||Statistical comparison was performed at a 2-sided 0.10 significance level.|Mixed Models Analysis|||Isotime: LSMeans, LSMean difference of CK-2127107 minus placebo, and 90% confidence intervals are based on a mixed effect model with treatment and period as fixed effects, subject as a random effect, and a compound symmetry covariance structure.||10.7|-10.3|0.976
72620293|NCT02662582|144771761|SUPERIORITY||LSMean difference|-0.6||||0.844|TWO_SIDED|90.0|-6.1|4.9||Statistical comparison was performed at a 2-sided 0.10 significance level.|Mixed Models Analysis|||Peak: LSMeans, LSMean difference of CK-2127107 minus placebo, and 90% confidence intervals are based on a mixed effect model with treatment and period as fixed effects, subject as a random effect, and a compound symmetry covariance structure.||4.9|-6.1|0.844
72620294|NCT02662582|144771761|SUPERIORITY||LSMean difference|-0.9||||0.751|TWO_SIDED|90.0|-5.8|4.0||Statistical comparison was performed at a 2-sided 0.10 significance level.|Mixed Models Analysis|||Isotime: LSMeans, LSMean difference of CK-2127107 minus placebo, and 90% confidence intervals are based on a mixed effect model with treatment and period as fixed effects, subject as a random effect, and a compound symmetry covariance structure.||4.0|-5.8|0.751
72620295|NCT02662582|144771762|SUPERIORITY||LSMean difference|0.2||||0.59|TWO_SIDED|90.0|-0.5|0.9||Statistical comparison was performed at a 2-sided 0.10 significance level.|Mixed Models Analysis|||Peak: LSMeans, LSMean difference of CK-2127107 minus placebo, and 90% confidence intervals are based on a mixed effect model with treatment and period as fixed effects, subject as a random effect, and a compound symmetry covariance structure.||0.9|-0.5|0.590
72620296|NCT02662582|144771762|SUPERIORITY||LSMean difference|0.3||||0.399|TWO_SIDED|90.0|-0.3|0.9||Statistical comparison was performed at a 2-sided 0.10 significance level.|Mixed Models Analysis|||Isotime: LSMeans, LSMean difference of CK-2127107 minus placebo, and 90% confidence intervals are based on a mixed effect model with treatment and period as fixed effects, subject as a random effect, and a compound symmetry covariance structure.||0.9|-0.3|0.399
72454379|NCT06214052|144432655|OTHER||EC50|1.88|STANDARD_ERROR_OF_MEAN|26.0||||||||||||||||
72454380|NCT02434328|144432660|NON_INFERIORITY|The noninferiority margin was 4 letters.|Least Squares Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.86|<|0.0001|TWO_SIDED|95.0|-2.4|1.0||1-sided p-value reported. Hypothesis tested according to the pre-specified hierarchical testing that ensures the global type I error rate at 0.05.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|||1.0|-2.4|<0.0001
72454381|NCT02434328|144432661|NON_INFERIORITY|The non-inferiority margin was 4 letters.|Least Squares Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|0.82||0.0003|TWO_SIDED|95.0|-2.8|0.5||1-sided p-value reported. Hypothesis tested according to the pre-specified hierarchical testing that ensures the global type I error rate at 0.05.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|||0.5|-2.8|0.0003
72620297|NCT02662582|144771763|SUPERIORITY||LSMean difference|-0.09||||0.151|TWO_SIDED|90.0|-0.2|0.01||Statistical comparison was performed at a 2-sided 0.10 significance level.|Mixed Models Analysis|||LSMeans, LSMean difference of CK-2127107 minus placebo, and 90% confidence intervals are based on a mixed effect model with treatment and period as fixed effects, subject as a random effect, and a compound symmetry covariance structure.||0.01|-0.20|0.151
72620298|NCT02662582|144771764|SUPERIORITY||LSMean difference|-0.007||||0.857|TWO_SIDED|90.0|-0.07|0.056||Statistical comparison was performed at a 2-sided 0.10 significance level.|Mixed Models Analysis|||LSMeans, LSMean difference of CK-2127107 minus placebo, and 90% confidence intervals are based on a mixed effect model with treatment and period as fixed effects, subject as a random effect, and a compound symmetry covariance structure.||0.056|-0.070|0.857
72620299|NCT02662582|144771765|SUPERIORITY||LSMean difference|1.56||||0.11|TWO_SIDED|90.0|-0.05|3.17||Statistical comparison was performed at a 2-sided 0.10 significance level.|Mixed Models Analysis|||LSMeans, LSMean difference of CK-2127107 minus placebo, and 90% confidence intervals are based on a mixed effect model with treatment and period as fixed effects, subject as a random effect, and a compound symmetry covariance structure.||3.17|-0.05|0.110
72620300|NCT02662582|144771766|SUPERIORITY||LSMean difference|2.07||||0.766|TWO_SIDED|90.0|-9.57|13.71||Statistical comparison was performed at a 2-sided 0.10 significance level.|Mixed Models Analysis|||Peak: LSMeans, LSMean difference of CK-2127107 minus placebo, and 90% confidence intervals are based on a mixed effect model with treatment and period as fixed effects, subject as a random effect, and a compound symmetry covariance structure.||13.71|-9.57|0.766
72620301|NCT02662582|144771766|SUPERIORITY||LSMean difference|2.94||||0.642|TWO_SIDED|90.0|-7.66|13.54||Statistical comparison was performed at a 2-sided 0.10 significance level.|Mixed Models Analysis|||Isotime: LSMeans, LSMean difference of CK-2127107 minus placebo, and 90% confidence intervals are based on a mixed effect model with treatment and period as fixed effects, subject as a random effect, and a compound symmetry covariance structure.||13.54|-7.66|0.642
72620302|NCT02739828|144771794|SUPERIORITY|||||||0.0001|||||||paired t-test|||Analysis is under the assumption of completely missing at random (deleted incomplete observations).||||0.0001
72620303|NCT02739828|144771795|SUPERIORITY||||||<|0.0001|||||||paired t-test|||Analysis is under the assumption of completely missing at random (deleted incomplete observations).||||< 0.0001
72620304|NCT02739828|144771796|SUPERIORITY|||||||0.0004|||||||paired t-test|||Analysis is under the assumption of completely missing at random (deleted incomplete observations).||||0.0004
72454382|NCT02434328|144432666|OTHER|Treatment difference|Least Squares Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.52|||TWO_SIDED|95.0|-2.0|0.0||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 4||0.0|-2.0|
72454383|NCT02434328|144432666|OTHER|Treatment difference|Least Squares Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.63|||TWO_SIDED|95.0|-2.2|0.2||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 8||0.2|-2.2|
72620305|NCT02739828|144771797|SUPERIORITY|||||||0.0005|||||||paired t-test|||Skin pain at its worst. Analysis is under the assumption of completely missing at random (deleted incomplete observations).||||0.0005
72620306|NCT02739828|144771797|SUPERIORITY|||||||0.0006|||||||paired t-test|||Skin pain on average. Analysis is under the assumption of completely missing at random (deleted incomplete observations).||||0.0006
72620307|NCT02739828|144771798|SUPERIORITY|||||||0.0004|||||||paired t-test|||Skin pain at its worst. Analysis is under the assumption of completely missing at random (deleted incomplete observations).||||0.0004
72620308|NCT02739828|144771798|SUPERIORITY|||||||0.0016|||||||paired t-test|||Skin pain on average. Analysis is under the assumption of completely missing at random (deleted incomplete observations).||||0.0016
72620309|NCT02739828|144771799|SUPERIORITY|||||||0.0003|||||||paired t-test|||Skin pain at its worst. Analysis is under the assumption of completely missing at random (deleted incomplete observations).||||0.0003
72620310|NCT02739828|144771799|SUPERIORITY|||||||0.0094|||||||paired t-test|||Skin pain on average. Analysis is under the assumption of completely missing at random (deleted incomplete observations).||||0.0094
72620311|NCT02739828|144771803|SUPERIORITY|||||||0.0278|||||||paired t-test|||Analysis is under the assumption of completely missing at random (deleted incomplete observations).||||0.0278
72620312|NCT02739828|144771804|SUPERIORITY|||||||0.0215|||||||paired t-test|||Analysis is under the assumption of completely missing at random (deleted incomplete observations).||||0.0215
72620313|NCT02739828|144771805|SUPERIORITY|||||||0.1652|||||||paired t-test|||Analysis is under the assumption of completely missing at random (deleted incomplete observations).||||0.1652
72620314|NCT02739828|144771809|SUPERIORITY|||||||1|||||||Sign test|||Analysis is under the assumption of completely missing at random (deleted incomplete observations).||||1.0000
72620315|NCT02739828|144771810|SUPERIORITY|||||||1|||||||Sign test|||Analysis is under the assumption of completely missing at random (deleted incomplete observations).||||1.0000
72620316|NCT02739828|144771811|SUPERIORITY|||||||0.5|||||||Sign test|||Analysis is under the assumption of completely missing at random (deleted incomplete observations).||||0.5000
72620317|NCT02739828|144771812|SUPERIORITY|||||||0.1797|||||||Sign test|||Analysis is under the assumption of completely missing at random (deleted incomplete observations).||||0.1797
72620318|NCT02739828|144771813|SUPERIORITY|||||||0.4531|||||||Sign test|||Analysis is under the assumption of completely missing at random (deleted incomplete observations).||||0.4531
72620319|NCT02739828|144771814|SUPERIORITY|||||||0.0313|||||||Sign test|||Analysis is under the assumption of completely missing at random (deleted incomplete observations).||||0.0313
72620320|NCT02739828|144771815|SUPERIORITY|||||||0.3438|||||||Sign test|||Analysis is under the assumption of completely missing at random (deleted incomplete observations).||||0.3438
72620321|NCT02739828|144771816|SUPERIORITY|||||||0.4531|||||||Sign test|||Analysis is under the assumption of completely missing at random (deleted incomplete observations).||||0.4531
72620322|NCT02739828|144771817|SUPERIORITY|||||||0.0156|||||||Sign test|||Analysis is under the assumption of completely missing at random (deleted incomplete observations).||||0.0156
72620323|NCT02739828|144771818|SUPERIORITY|||||||0.0386|||||||Sign test|||Analysis is under the assumption of completely missing at random (deleted incomplete observations).||||0.0386
72454384|NCT02434328|144432666|OTHER|Treatment difference|Least Squares Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.71|||TWO_SIDED|95.0|-2.4|0.4||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 12||0.4|-2.4|
72454385|NCT02434328|144432666|OTHER|Treatment difference|Least Squares Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|0.73|||TWO_SIDED|95.0|-2.3|0.6||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 16||0.6|-2.3|
72454386|NCT02434328|144432666|OTHER|Treatment difference|Least Squares Mean Difference|-1.5|STANDARD_ERROR_OF_MEAN|0.76|||TWO_SIDED|95.0|-3.0|0.0||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 20||0.0|-3.0|
72454387|NCT02434328|144432666|OTHER|Treatment difference|Least Squares Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|0.79|||TWO_SIDED|95.0|-2.5|0.6||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 24||0.6|-2.5|
72454388|NCT02434328|144432666|OTHER|Treatment difference|Least Squares Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|0.82|||TWO_SIDED|95.0|-2.7|0.5||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 28||0.5|-2.7|
72454389|NCT02434328|144432666|OTHER|Treatment difference|Least Squares Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|0.81|||TWO_SIDED|95.0|-2.5|0.7||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 32||0.7|-2.5|
72454390|NCT02434328|144432666|OTHER|Treatment difference|Least Squares Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|0.84|||TWO_SIDED|95.0|-2.9|0.4||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 36||0.4|-2.9|
72454391|NCT02434328|144432666|OTHER|Treatment difference|Least Squares Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|0.85|||TWO_SIDED|95.0|-2.9|0.5||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 40||0.5|-2.9|
72454392|NCT02434328|144432666|OTHER|Treatment difference|Least Squares Mean Difference|-1.6|STANDARD_ERROR_OF_MEAN|0.86|||TWO_SIDED|95.0|-3.2|0.1||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 44||0.1|-3.2|
72391782|NCT00256750|144290855|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|1.5||||0.1961|TWO_SIDED|95.0|-0.8|3.7||Baseline observations were not used for imputations at subsequent time points.|ANOVA|ANOVA model: Component Score = treatment. Missing values were imputed using last observation carried forward (LOCF) method.|Statistical tests comparing each belatacept regimen to the CsA regimen were conducted at a significance level of 0.05. Subjects with only baseline observations were excluded from these summaries.|Mental Component Score; Month 36||3.7|-0.8|0.1961
72499730|NCT01431287|144529543|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.371|STANDARD_ERROR_OF_MEAN|0.142||0.0089|TWO_SIDED|95.0|0.093|0.649||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.649|0.093|0.0089
72499731|NCT01431287|144529543|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.332|STANDARD_ERROR_OF_MEAN|0.141||0.0186|TWO_SIDED|95.0|0.056|0.609||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.609|0.056|0.0186
72499732|NCT01431287|144529543|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.046|STANDARD_ERROR_OF_MEAN|0.142||0.7441|TWO_SIDED|95.0|-0.231|0.324||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.324|-0.231|0.7441
72454393|NCT02434328|144432666|OTHER|Treatment difference|Least Squares Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.86|||TWO_SIDED|95.0|-2.4|1.0||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 48||1.0|-2.4|
72454394|NCT02434328|144432666|OTHER|Treatment difference|Least Squares Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.9|||TWO_SIDED|95.0|-2.5|1.1||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 52||1.1|-2.5|
72454395|NCT02434328|144432666|OTHER|Treatment difference|Least Squares Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.92|||TWO_SIDED|95.0|-2.5|1.1||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 56||1.1|-2.5|
72454396|NCT02434328|144432666|OTHER|Treatment difference|Least Squares Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.93|||TWO_SIDED|95.0|-2.7|1.0||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 60||1.0|-2.7|
72620324|NCT02739828|144771819|SUPERIORITY|||||||0.3438|||||||Sign test|||Analysis is under the assumption of completely missing at random (deleted incomplete observations).||||0.3438
72620325|NCT02739828|144771820|SUPERIORITY|||||||0.125|||||||Sign test|||Analysis is under the assumption of completely missing at random (deleted incomplete observations).||||0.1250
72391783|NCT00256750|144290855|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|2.1||||0.0191|TWO_SIDED|95.0|0.3|3.9||Baseline observations were not used for imputations at subsequent time points.|ANOVA|ANOVA model: Component Score = treatment. Missing values were imputed using last observation carried forward (LOCF) method.|Statistical tests comparing each belatacept regimen to the CsA regimen were conducted at a significance level of 0.05. Subjects with only baseline observations were excluded from these summaries.|Physical Component Score; Month 36||3.9|0.3|0.0191
72454397|NCT02434328|144432666|OTHER|Treatment difference|Least Squares Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.95|||TWO_SIDED|95.0|-2.5|1.2||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 64||1.2|-2.5|
72454398|NCT02434328|144432666|OTHER|Treatment difference|Least Squares Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.96|||TWO_SIDED|95.0|-2.5|1.2||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 68||1.2|-2.5|
72454399|NCT02434328|144432666|OTHER|Treatment difference|Least Squares Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|0.98|||TWO_SIDED|95.0|-2.8|1.1||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 72||1.1|-2.8|
72454400|NCT02434328|144432666|OTHER|Treatment difference|Least Squares Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.98|||TWO_SIDED|95.0|-2.5|1.4||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 76||1.4|-2.5|
72391784|NCT00256750|144290855|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|1.7||||0.0684|TWO_SIDED|95.0|-0.1|3.5||Baseline observations were not used for imputations at subsequent time points.|ANOVA|ANOVA model: Component Score = treatment. Missing values were imputed using last observation carried forward (LOCF) method.|Statistical tests comparing each belatacept regimen to the CsA regimen were conducted at a significance level of 0.05. Subjects with only baseline observations were excluded from these summaries.|Physical Component Score; Month 36||3.5|-0.1|0.0684
72454401|NCT02434328|144432666|OTHER|Treatment difference|Least Squares Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.99|||TWO_SIDED|95.0|-2.1|1.8||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 80||1.8|-2.1|
72454402|NCT02434328|144432666|OTHER|Treatment difference|Least Squares Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|1.0|||TWO_SIDED|95.0|-2.9|1.1||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 84||1.1|-2.9|
72454403|NCT02434328|144432666|OTHER|Treatment difference|Least Squares Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.99|||TWO_SIDED|95.0|-2.6|1.3||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 88||1.3|-2.6|
72391785|NCT00256750|144290856|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|1.9||||0.0714|TWO_SIDED|95.0|-0.2|3.9|||ANOVA|Domain Score = treatment|Missing data were imputed by LOCF|Bodily Pain, Month 6||3.9|-0.2|0.0714
72391786|NCT00256750|144290856|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|2.0||||0.0536|TWO_SIDED|95.0|0.0|4.1|||ANOVA|Domain score = treatment|Missing data were imputed by LOCF|Bodily Pain, Month 6||4.1|-0.0|0.0536
72391787|NCT00256750|144290856|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|0.3||||0.7543|TWO_SIDED|95.0|-1.6|2.2|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|General Health, Month 6||2.2|-1.6|0.7543
72454404|NCT02434328|144432666|OTHER|Treatment difference|Least Squares Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|1.02|||TWO_SIDED|95.0|-2.4|1.6||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 92||1.6|-2.4|
72454405|NCT02434328|144432666|OTHER|Treatment difference|Least Squares Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|1.04|||TWO_SIDED|95.0|-2.5|1.6||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 96||1.6|-2.5|
72454406|NCT02434328|144432667|OTHER|Treatment difference|Least Squares Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|0.69|||TWO_SIDED|95.0|-2.4|0.3||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 4 to Week 48||0.3|-2.4|
72454407|NCT02434328|144432667|OTHER|Treatment difference|Least Squares Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.78|||TWO_SIDED|95.0|-2.4|0.7||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 4 to Week 96||0.7|-2.4|
72454408|NCT02434328|144432668|OTHER|Treatment difference|Least Squares Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|0.74|||TWO_SIDED|95.0|-2.5|0.4||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 12 to Week 48||0.4|-2.5|
72454409|NCT02434328|144432668|OTHER|Treatment difference|Least Squares Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.82|||TWO_SIDED|95.0|-2.4|0.8||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.||Week 12 to Week 96|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|0.8|-2.4|
72454410|NCT02434328|144432669|OTHER|Treatment difference|Least Squares Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.99|||TWO_SIDED|95.0|-2.5|1.4||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|||1.4|-2.5|
72620326|NCT02739828|144771821|SUPERIORITY|||||||0.0625|||||||Sign test|||Analysis is under the assumption of completely missing at random (deleted incomplete observations).||||0.0625
72391788|NCT00256750|144290856|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|1.1||||0.2499|TWO_SIDED|95.0|-0.8|3.0|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|General Health, Month 6||3.0|-0.8|0.2499
72454411|NCT02434328|144432670|OTHER||Difference in proportions|-1.3|||||TWO_SIDED|95.0|-5.1|2.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 4||2.9|-5.1|
72454412|NCT02434328|144432670|OTHER||Difference in proportions|-4.3|||||TWO_SIDED|95.0|-9.5|1.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 8||1.0|-9.5|
72391789|NCT00256750|144290856|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|0.2||||0.8332|TWO_SIDED|95.0|-1.9|2.3|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Mental Health, Month 6||2.3|-1.9|0.8332
72454413|NCT02434328|144432670|OTHER||Difference in proportions|-5.0|||||TWO_SIDED|95.0|-10.5|0.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 12||0.3|-10.5|
72454414|NCT02434328|144432670|OTHER||Difference in proportions|-2.3|||||TWO_SIDED|95.0|-8.4|3.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 16||3.7|-8.4|
72454415|NCT02434328|144432670|OTHER||Difference in proportions|-3.1|||||TWO_SIDED|95.0|-8.8|2.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 20||2.8|-8.8|
72454416|NCT02434328|144432670|OTHER||Difference in proportions|0.9|||||TWO_SIDED|95.0|-5.2|6.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 24||6.7|-5.2|
72499733|NCT01431287|144529543|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.276|STANDARD_ERROR_OF_MEAN|0.14||0.0492|TWO_SIDED|95.0|0.001|0.551||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.551|0.001|0.0492
72499734|NCT01431287|144529543|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.608|STANDARD_ERROR_OF_MEAN|0.141|<|0.0001|TWO_SIDED|95.0|0.332|0.884||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.884|0.332|<0.0001
72562591|NCT02788513|144656891|OTHER||Mean Difference (Final Values)|-2.16|STANDARD_ERROR_OF_MEAN|0.76||0.005|TWO_SIDED|95.0|-3.65|-0.67||p-values are nominal without multiplicity adjustment.|ANCOVA|Analysis of Covariance model included baseline value for the secondary endpoint measure, MMSE stratification (\>=20, \<20) at baseline and treatment.||Analysis of Covariance (ANCOVA)||-0.67|-3.65|0.005
72454417|NCT02434328|144432670|OTHER||Difference in proportions|-3.7|||||TWO_SIDED|95.0|-9.9|2.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 28||2.3|-9.9|
72391790|NCT00256750|144290856|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|1.3||||0.2523|TWO_SIDED|95.0|-0.9|3.4|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Mental Health, Month 6||3.4|-0.9|0.2523
72391791|NCT00256750|144290856|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|0.9||||0.3018|TWO_SIDED|95.0|-0.8|2.7|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Physical Functioning, Month 6||2.7|-0.8|0.3018
72391792|NCT00256750|144290856|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|0.6||||0.5437|TWO_SIDED|95.0|-1.2|2.3|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Physical Functioning, Month 6||2.3|-1.2|0.5437
72454418|NCT02434328|144432670|OTHER||Difference in proportions|-3.6|||||TWO_SIDED|95.0|-10.5|2.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 32||2.7|-10.5|
72454419|NCT02434328|144432670|OTHER||Difference in proportions|-4.9|||||TWO_SIDED|95.0|-11.6|1.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 36||1.3|-11.6|
72454420|NCT02434328|144432670|OTHER||Difference in proportions|-4.7|||||TWO_SIDED|95.0|-11.5|1.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 40||1.9|-11.5|
72454421|NCT02434328|144432670|OTHER||Difference in proportions|-4.6|||||TWO_SIDED|95.0|-11.3|1.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 44||1.8|-11.3|
72620327|NCT02739828|144771822|SUPERIORITY|||||||0.0625|||||||Sign test|||Analysis is under the assumption of completely missing at random (deleted incomplete observations).||||0.0625
72391793|NCT00256750|144290856|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|1.3||||0.237|TWO_SIDED|95.0|-0.9|3.6|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Role Emotional, Month 6||3.6|-0.9|0.2370
72454422|NCT02434328|144432670|OTHER||Difference in proportions|-0.6|||||TWO_SIDED|95.0|-7.1|5.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 48||5.8|-7.1|
72454423|NCT02434328|144432670|OTHER||Difference in proportions|-0.6|||||TWO_SIDED|95.0|-7.0|5.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 52||5.5|-7.0|
72454424|NCT02434328|144432670|OTHER||Difference in proportions|-1.1|||||TWO_SIDED|95.0|-7.7|5.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 56||5.4|-7.7|
72454425|NCT02434328|144432670|OTHER||Difference in proportions|-2.2|||||TWO_SIDED|95.0|-8.3|4.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 60||4.2|-8.3|
72454426|NCT02434328|144432670|OTHER||Difference in proportions|-1.4|||||TWO_SIDED|95.0|-7.9|5.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 64||5.4|-7.9|
72499735|NCT01431287|144529543|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.325|STANDARD_ERROR_OF_MEAN|0.143||0.023|TWO_SIDED|95.0|0.045|0.605||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.605|0.045|0.0230
72499736|NCT01431287|144529543|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.039|STANDARD_ERROR_OF_MEAN|0.142||0.7855|TWO_SIDED|95.0|-0.24|0.317||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.317|-0.240|0.7855
72499737|NCT01431287|144529543|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.286|STANDARD_ERROR_OF_MEAN|0.142||0.0442|TWO_SIDED|95.0|0.007|0.564||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.564|0.007|0.0442
72499738|NCT00110305|144529546|SUPERIORITY_OR_OTHER||Differences in response rate|0.5||||0.92|TWO_SIDED|95.0|-10.4|11.3||The significance level for each comparison was 5% (two-sided). No further adjustment of this significance level was applied.|Regression, Logistic|This model with factors treatment, region, and Nucleoside/tide reverse transcriptase inhibitors (N\[t\]RTIs) used, and baseline viral load as covariate.||||11.3|-10.4|0.92
72499739|NCT00110305|144529546|SUPERIORITY_OR_OTHER||Difference in response rate|-2.3||||0.56|TWO_SIDED|95.0|-13.6|9.0||The significance level for each comparison was 5% (two-sided). No further adjustment of this significance level was applied.|Regression, Logistic|This model with factors treatment, region, and N(t)RTIs used, and baseline viral load as covariate.||||9.0|-13.6|0.56
72499740|NCT00110305|144529546|SUPERIORITY_OR_OTHER||Difference in response rate|-2.8||||0.62|TWO_SIDED|95.0|-14.0|8.4||The significance level for each comparison was 5% (two-sided). No further adjustment of this significance level was applied.|Regression, Logistic|This model with factors treatment, region, and N(t)RTIs used, and baseline viral load as covariate.||||8.4|-14.0|0.62
72454427|NCT02434328|144432670|OTHER||Difference in proportions|-3.5|||||TWO_SIDED|95.0|-9.9|3.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 68||3.1|-9.9|
72391794|NCT00256750|144290856|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|2.2||||0.0588|TWO_SIDED|95.0|-0.1|4.5|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Role Emotional, Month 6||4.5|-0.1|0.0588
72454428|NCT02434328|144432670|OTHER||Difference in proportions|-4.1|||||TWO_SIDED|95.0|-10.2|2.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 72||2.3|-10.2|
72454429|NCT02434328|144432670|OTHER||Difference in proportions|-2.4|||||TWO_SIDED|95.0|-8.8|4.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 76||4.0|-8.8|
72454430|NCT02434328|144432670|OTHER||Difference in proportions|-2.6|||||TWO_SIDED|95.0|-9.0|3.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 80||3.5|-9.0|
72499741|NCT00110305|144529546|SUPERIORITY_OR_OTHER||Difference in response rate|-1.5||||0.8|TWO_SIDED|95.0|-10.5|7.5||The significance level for each comparison was 5% (two-sided). No further adjustment of this significance level was applied.|Regression, Logistic|This model with factors treatment, region, and N(t)RTIs used, and baseline viral load as covariate.||||7.5|-10.5|0.80
72562592|NCT02788513|144656892|OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.11||0.343|TWO_SIDED|95.0|-0.32|0.11||p-values are nominal without multiplicity adjustment.|ANCOVA|ANCOVA included MMSE stratification (\>=20, \<20) at baseline (BL) and treatment, CIBIS is included as BL adjustment term.||Analysis of Covariance (ANCOVA)||0.11|-0.32|0.343
72562593|NCT02788513|144656892|OTHER||Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.11||0.645|TWO_SIDED|95.0|-0.26|0.16||p-values are nominal without multiplicity adjustment.|ANCOVA|ANCOVA included MMSE stratification (\>=20, \<20) at baseline (BL) and treatment, CIBIS is included as BL adjustment term.||Analysis of Covariance (ANCOVA)||0.16|-0.26|0.645
72562594|NCT02788513|144656892|OTHER||Mean Difference (Final Values)|0.08|STANDARD_ERROR_OF_MEAN|0.11||0.448|TWO_SIDED|95.0|-0.13|0.3||p-values are nominal without multiplicity adjustment.|ANCOVA|ANCOVA included MMSE stratification (\>=20, \<20) at baseline (BL) and treatment, CIBIS is included as BL adjustment term.||Analysis of Covariance (ANCOVA)||0.30|-0.13|0.448
72562595|NCT02788513|144656892|OTHER||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.11||0.34|TWO_SIDED|95.0|-0.11|0.32||p-values are nominal without multiplicity adjustment.|ANCOVA|ANCOVA included MMSE stratification (\>=20, \<20) at baseline (BL) and treatment, CIBIS is included as BL adjustment term.||Analysis of Covariance (ANCOVA)||0.32|-0.11|0.340
72391795|NCT00256750|144290856|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|2.0||||0.0502|TWO_SIDED|95.0|0.0|4.0|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Role Physical, Month 6||4.0|-0.0|0.0502
72391796|NCT00256750|144290856|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|3.6||||0.0007|TWO_SIDED|95.0|1.5|5.6|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Role-Physical, Month 6||5.6|1.5|0.0007
72391797|NCT00256750|144290856|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|0.3||||0.7637|TWO_SIDED|95.0|-1.8|2.4|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Social Functioning, Month 6||2.4|-1.8|0.7637
72454431|NCT02434328|144432670|OTHER||Difference in proportions|-3.8|||||TWO_SIDED|95.0|-9.9|2.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 84||2.8|-9.9|
72454432|NCT02434328|144432670|OTHER||Difference in proportions|-5.8|||||TWO_SIDED|95.0|-11.8|0.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 88||0.3|-11.8|
72454433|NCT02434328|144432670|OTHER||Difference in proportions|-1.7|||||TWO_SIDED|95.0|-7.9|4.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 92||4.5|-7.9|
72454434|NCT02434328|144432670|OTHER||Difference in proportions|-2.4|||||TWO_SIDED|95.0|-8.8|4.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 96||4.1|-8.8|
72454435|NCT02434328|144432671|OTHER||Difference in proportions|-2.1|||||TWO_SIDED|95.0|-7.6|3.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 4||3.8|-7.6|
72454436|NCT02434328|144432671|OTHER||Difference in proportions|-6.0|||||TWO_SIDED|95.0|-13.0|0.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 8||0.1|-13.0|
72454437|NCT02434328|144432671|OTHER||Difference in proportions|-3.8|||||TWO_SIDED|95.0|-10.1|2.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 12||2.4|-10.1|
72454438|NCT02434328|144432671|OTHER||Difference in proportions|-0.5|||||TWO_SIDED|95.0|-7.3|6.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 16||6.3|-7.3|
72454439|NCT02434328|144432671|OTHER||Difference in proportions|-4.6|||||TWO_SIDED|95.0|-11.2|2.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 20||2.2|-11.2|
72454440|NCT02434328|144432671|OTHER||Difference in proportions|-3.7|||||TWO_SIDED|95.0|-10.7|3.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 24||3.0|-10.7|
72454441|NCT02434328|144432671|OTHER||Difference in proportions|-2.4|||||TWO_SIDED|95.0|-9.6|4.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 28||4.0|-9.6|
72562596|NCT01933919|144656915|SUPERIORITY||LS Mean Difference (Fluvoxamine-Placebo)|-4.3|STANDARD_ERROR_OF_MEAN|2.07||0.044|TWO_SIDED|95.0|-8.5|-0.1|||ANCOVA|ANCOVA with baseline JCY-BOCS (10-item) total score and age as covariates and treatment as fixed effect.|The model included the fixed effects of treatment, with baseline JCY-BOCS (10-item) total score and age as covariates.|||-0.1|-8.5|0.044
72562597|NCT03404401|144657030|NON_INFERIORITY|Non-inferiority margin was set at 10%.|||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
72454442|NCT02434328|144432671|OTHER||Difference in proportions|-2.6|||||TWO_SIDED|95.0|-9.4|4.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 32||4.5|-9.4|
72454443|NCT02434328|144432671|OTHER||Difference in proportions|-5.4|||||TWO_SIDED|95.0|-12.1|1.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 36||1.1|-12.1|
72454444|NCT02434328|144432671|OTHER||Difference in proportions|-3.1|||||TWO_SIDED|95.0|-9.9|3.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 40||3.5|-9.9|
72454445|NCT02434328|144432671|OTHER||Difference in proportions|-3.0|||||TWO_SIDED|95.0|-10.3|4.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 44||4.2|-10.3|
72499742|NCT00110305|144529547|SUPERIORITY_OR_OTHER||Difference in response rate|-4.8||||0.45|TWO_SIDED|95.0|-17.1|7.6||The significance level for each comparison was 5% (two-sided). No further adjustment of this significance level was applied.|Regression, Logistic|This model with factors treatment, region, and Nucleoside/tide reverse transcriptase inhibitors (N\[t\]RTIs) used, and baseline viral load as covariate.||||7.6|-17.1|0.45
72562598|NCT00988208|144657035|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.53||||0.0017|TWO_SIDED|95.0|1.17|2.0||p-value is based on unstratified log-rank test|Log Rank|||||2.00|1.17|0.0017
72562599|NCT00988208|144657036|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.32||||0.0187|TWO_SIDED|95.0|1.05|1.66|||Log Rank|P-value is based on unstratified log-rank test||||1.66|1.05|0.0187
72562600|NCT00988208|144657037|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.884||||0.3975|TWO_SIDED|95.0|0.665|1.176|||Chi-squared|||||1.176|0.665|0.3975
72562601|NCT03008837|144657045|OTHER|Using seed-based analysis with a right posterior insula seed, cluster size was set at 40 voxels, and p-value was thresholded at p\<0.05 to compare the differences between the two groups in terms of connectivity between the right posterior insula and areas of the DMN identified based on a priori hypotheses.|Mean Difference (Final Values)|40.0|||<|0.05|TWO_SIDED||||||t-test, 2 sided||Standard therapy control (post-pre) was subtracted from PENFS (post-pre).|PENFS (post-pre) - Standard Therapy (post-pre)||||<0.05
72562602|NCT02445287|144657051|SUPERIORITY_OR_OTHER|||||||0.92||||||Level of significance (alpha) = 0.05|t-test, 2 sided|||||||0.920
72562603|NCT02445287|144657052|SUPERIORITY_OR_OTHER|||||||0||||||Level of significance (alpha) = 0.05|t-test, 1 sided|||||||0.000
72562604|NCT02445287|144657053|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence interval = (-0.25, 0.25)||||||0||||||level of significance (alpha) = 0.05|Equivalence test|||||||0.000
72391798|NCT00256750|144290856|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|0.4||||0.7006|TWO_SIDED|95.0|-1.7|2.5|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Social Functioning, Month 6||2.5|-1.7|0.7006
72454446|NCT02434328|144432671|OTHER||Difference in proportions|-1.9|||||TWO_SIDED|95.0|-8.7|4.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 48||4.7|-8.7|
72454447|NCT02434328|144432671|OTHER||Difference in proportions|-1.3|||||TWO_SIDED|95.0|-8.0|5.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 52||5.7|-8.0|
72454448|NCT02434328|144432671|OTHER||Difference in proportions|-2.8|||||TWO_SIDED|95.0|-9.8|4.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 56||4.3|-9.8|
72562605|NCT02445287|144657054|SUPERIORITY_OR_OTHER|||||||0.012||||||level of significance (alpha) = 0.05|t-test, 1 sided|||||||0.012
72562606|NCT03235479|144657055|SUPERIORITY||Risk Difference (RD)|4.9||||0.0298|TWO_SIDED|95.0|0.5|9.3|||Cochran-Mantel-Haenszel|||||9.3|0.5|0.0298
72562607|NCT03235479|144657056|SUPERIORITY||Risk Difference (RD)|8.9||||0.0016|TWO_SIDED|95.0|3.4|14.4|||Cochran-Mantel-Haenszel|||||14.4|3.4|0.0016
72562608|NCT03235479|144657057|SUPERIORITY||Risk Difference (RD)|10.2||||0.0005|TWO_SIDED|95.0|4.4|15.9|||Cochran-Mantel-Haenszel|||||15.9|4.4|0.0005
72562609|NCT03235479|144657058|SUPERIORITY||Risk Difference (RD)|7.7||||0.0299|TWO_SIDED|95.0|0.8|14.6|||Cochran-Mantel-Haenszel|||||14.6|0.8|0.0299
72562610|NCT03235479|144657059|SUPERIORITY||Risk Difference (RD)|10.3||||0.0006|TWO_SIDED|95.0|4.4|16.2|||Cochran-Mantel-Haenszel|||||16.2|4.4|0.0006
72562611|NCT03235479|144657060|SUPERIORITY||Risk Difference (RD)|5.2||||0.1815|TWO_SIDED|95.0|-2.4|12.9||P-value ≥ 0.05; therefore, all secondary outcome measures listed after this outcome measure in the hierarchy were not tested.|Cochran-Mantel-Haenszel|||||12.9|-2.4|0.1815
72562612|NCT00693225|144657084|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|||||||1.0
72562613|NCT01315028|144657087|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANOVA|||||||0.05
72562614|NCT01315028|144657088|SUPERIORITY_OR_OTHER|||||||0.996||95.0|||||ANOVA|||Parametric and non-parametric descriptive data were summarised and presented. All data analyses were based on the Intention to Treat (ITT) principle. For the main analysis, Repeated Measures Analysis of Variance was performed to identify signals suggesting treatment effects on the outcome measures. Effect sizes were also calculated in order to further examine suggestive trends in the data indicating appropriate outcomes for further research.||||0.996
72562615|NCT01315028|144657089|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||ANOVA|||||||<0.05
72562616|NCT01315028|144657090|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||ANOVA|||||||<0.05
72454449|NCT02434328|144432671|OTHER|Hypothesis testing not pre-specified.|Difference in proportions|-2.8|||||TWO_SIDED|95.0|-9.6|4.2|||Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 60||4.2|-9.6|
72454450|NCT02434328|144432671|OTHER||Difference in proportions|-1.7|||||TWO_SIDED|95.0|-8.8|5.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 64||5.4|-8.8|
72454451|NCT02434328|144432671|OTHER||Difference in proportions|-1.7|||||TWO_SIDED|95.0|-8.4|5.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 68||5.0|-8.4|
72454452|NCT02434328|144432671|OTHER||Difference in proportions|-3.6|||||TWO_SIDED|95.0|-10.4|2.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 72||2.9|-10.4|
72454453|NCT02434328|144432671|OTHER||Difference in proportions|0.5|||||TWO_SIDED|95.0|-6.5|7.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 76||7.2|-6.5|
72454454|NCT02434328|144432671|OTHER||Difference in proportions|-0.7|||||TWO_SIDED|95.0|-7.5|6.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 80||6.1|-7.5|
72454455|NCT02434328|144432671|OTHER||Difference in proportions|-3.5|||||TWO_SIDED|95.0|-10.4|3.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 84||3.1|-10.4|
72454456|NCT02434328|144432671|OTHER||Difference in proportions|-2.5|||||TWO_SIDED|95.0|-9.6|3.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 88||3.9|-9.6|
72454457|NCT02434328|144432671|OTHER||Difference in proportions|1.9|||||TWO_SIDED|95.0|-5.0|8.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 92||8.3|-5.0|
72562617|NCT01077817|144657101|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.1|||||TWO_SIDED|95.0|0.7|1.5|||Logistic Regression Model|The case-cohort hazard ratio estimate for drug exposure was based on analysis of all cases of esophageal cancer and their comparison sample.||A hazard ratio estimate was calculated from the case-control matched set to measure the risk association between exposure to alendronate treatment and incidence of esophageal cancer.||1.5|0.7|
72391799|NCT00256750|144290856|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|1.5||||0.1222|TWO_SIDED|95.0|-0.4|3.4|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Vitality, Month 6||3.4|-0.4|0.1222
72391800|NCT00256750|144290856|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|2.2||||0.0289|TWO_SIDED|95.0|0.2|4.1|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Vitality, Month 6||4.1|0.2|0.0289
72454458|NCT02434328|144432671|OTHER||Difference in proportions|0.1|||||TWO_SIDED|95.0|-7.0|6.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 96||6.8|-7.0|
72391801|NCT00256750|144290856|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|1.9||||0.0571|TWO_SIDED|95.0|-0.1|3.8|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Bodily Pain, Month 12||3.8|-0.1|0.0571
72454459|NCT02434328|144432672|OTHER||Difference in proportions|-3.5|||||TWO_SIDED|95.0|-10.4|3.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 4||3.6|-10.4|
72454460|NCT02434328|144432672|OTHER||Difference in proportions|-3.2|||||TWO_SIDED|95.0|-10.2|3.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 8||3.7|-10.2|
72454461|NCT02434328|144432672|OTHER||Difference in proportions|-3.7|||||TWO_SIDED|95.0|-10.7|3.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 12||3.3|-10.7|
72454462|NCT02434328|144432672|OTHER||Difference in proportions|-1.4|||||TWO_SIDED|95.0|-8.4|5.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 16||5.7|-8.4|
72454463|NCT02434328|144432672|OTHER||Difference in proportions|-5.3|||||TWO_SIDED|95.0|-12.3|1.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 20||1.5|-12.3|
72454464|NCT02434328|144432672|OTHER||Difference in proportions|-3.2|||||TWO_SIDED|95.0|-9.9|3.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 24||3.7|-9.9|
72454465|NCT02434328|144432672|OTHER||Difference in proportions|-5.9|||||TWO_SIDED|95.0|-12.8|0.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 28||0.7|-12.8|
72454466|NCT02434328|144432672|OTHER||Difference in proportions|-1.9|||||TWO_SIDED|95.0|-8.2|4.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 32||4.8|-8.2|
72454467|NCT02434328|144432672|OTHER||Difference in proportions|-2.3|||||TWO_SIDED|95.0|-9.2|4.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 36||4.2|-9.2|
72454468|NCT02434328|144432672|OTHER||Difference in proportions|-1.3|||||TWO_SIDED|95.0|-8.2|5.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 40||5.6|-8.2|
72454469|NCT02434328|144432672|OTHER||Difference in proportions|-1.5|||||TWO_SIDED|95.0|-8.5|5.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 44||5.0|-8.5|
72454470|NCT02434328|144432672|OTHER||Difference in proportions|-0.2|||||TWO_SIDED|95.0|-7.4|6.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 48||6.2|-7.4|
72454471|NCT02434328|144432672|OTHER||Difference in proportions|-2.7|||||TWO_SIDED|95.0|-9.8|4.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 52||4.0|-9.8|
72454472|NCT02434328|144432672|OTHER||Difference in proportions|-1.7|||||TWO_SIDED|95.0|-8.6|4.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 56||4.8|-8.6|
72454473|NCT02434328|144432672|OTHER||Difference in proportions|-0.7|||||TWO_SIDED|95.0|-7.8|6.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 60||6.1|-7.8|
72454474|NCT02434328|144432672|OTHER||Difference in proportions|2.3|||||TWO_SIDED|95.0|-4.5|9.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 64||9.2|-4.5|
72454475|NCT02434328|144432672|OTHER||Difference in proportions|-1.5|||||TWO_SIDED|95.0|-8.6|4.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 68||4.9|-8.6|
72562618|NCT01077817|144657101|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.3|||||TWO_SIDED|95.0|0.9|2.0|||Logistic Regression Model|The case-cohort hazard ratio estimate for drug exposure was based on analysis of all cases of esophageal cancer and their comparison sample.||A hazard ratio estimate was calculated from the case-control matched set to measure the risk association between exposure to etidronate treatment and incidence of esophageal cancer.||2.0|0.9|
72391802|NCT00256750|144290856|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|2.9||||0.0042|TWO_SIDED|95.0|0.9|4.9|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Bodily Pain, Month 12||4.9|0.9|0.0042
72391803|NCT00256750|144290856|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|1.9||||0.0423|TWO_SIDED|95.0|0.1|3.7|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|General Health, Month 12||3.7|0.1|0.0423
72454476|NCT02434328|144432672|OTHER||Difference in proportions|1.1|||||TWO_SIDED|95.0|-5.8|7.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 72||7.5|-5.8|
72454477|NCT02434328|144432672|OTHER||Difference in proportions|2.0|||||TWO_SIDED|95.0|-5.1|8.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 76||8.4|-5.1|
72454478|NCT02434328|144432672|OTHER||Difference in proportions|4.2|||||TWO_SIDED|95.0|-2.8|10.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 80||10.9|-2.8|
72391804|NCT00256750|144290856|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|2.3||||0.0174|TWO_SIDED|95.0|0.4|4.1|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|General Health, Month 12||4.1|0.4|0.0174
72454479|NCT02434328|144432672|OTHER||Difference in proportions|-2.7|||||TWO_SIDED|95.0|-9.3|4.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 84||4.1|-9.3|
72454480|NCT02434328|144432672|OTHER||Difference in proportions|0.9|||||TWO_SIDED|95.0|-6.1|7.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 88||7.7|-6.1|
72454481|NCT02434328|144432672|OTHER||Difference in proportions|3.7|||||TWO_SIDED|95.0|-3.0|10.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 92||10.4|-3.0|
72454482|NCT02434328|144432672|OTHER||Difference in proportions|3.1|||||TWO_SIDED|95.0|-3.9|10.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 96||10.0|-3.9|
72454483|NCT02434328|144432673|OTHER||Difference in proportions|0.0|||||TWO_SIDED|95.0|-1.6|1.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 4||1.4|-1.6|
72454484|NCT02434328|144432673|OTHER||Difference in proportions|-0.6|||||TWO_SIDED|95.0|-2.3|1.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 8||1.1|-2.3|
72454485|NCT02434328|144432673|OTHER||Difference in proportions|0.0|||||TWO_SIDED|95.0|-1.9|2.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2 mg) was estimated using a bootstrap method.|Week 12||2.2|-1.9|
72454486|NCT02434328|144432673|OTHER||Difference in proportions|0.0|||||TWO_SIDED|95.0|-2.1|2.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 16||2.3|-2.1|
72454487|NCT02434328|144432673|OTHER||Difference in proportions|0.6|||||TWO_SIDED|95.0|-2.0|3.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 20||3.3|-2.0|
72454488|NCT02434328|144432673|OTHER||Difference in proportions|-0.5|||||TWO_SIDED|95.0|-3.0|2.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 24||2.2|-3.0|
72454489|NCT02434328|144432673|OTHER||Difference in proportions|-0.5|||||TWO_SIDED|95.0|-3.0|2.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 28||2.3|-3.0|
72454490|NCT02434328|144432673|OTHER||Difference in proportions|-0.5|||||TWO_SIDED|95.0|-3.2|2.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 32||2.5|-3.2|
72454491|NCT02434328|144432673|OTHER||Difference in proportions|0.4|||||TWO_SIDED|95.0|-2.3|3.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 36||3.3|-2.3|
72499743|NCT00110305|144529547|SUPERIORITY_OR_OTHER||Difference in response rate|-4.8||||0.45|TWO_SIDED|95.0|-17.3|7.7||The significance level for each comparison was 5% (two-sided). No further adjustment of this significance level was applied.|Regression, Logistic|This model with factors treatment, region, and N(t)RTIs used, and baseline viral load as covariate.||||7.7|-17.3|0.45
72391805|NCT00256750|144290856|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|1.0||||0.363|TWO_SIDED|95.0|-1.1|3.0|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Mental Health, Month 12||3.0|-1.1|0.3630
72454492|NCT02434328|144432673|OTHER||Difference in proportions|1.2|||||TWO_SIDED|95.0|-1.7|4.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 40||4.6|-1.7|
72454493|NCT02434328|144432673|OTHER||Difference in proportions|0.1|||||TWO_SIDED|95.0|-2.7|3.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 44||3.4|-2.7|
72454494|NCT02434328|144432673|OTHER||Difference in proportions|-1.0|||||TWO_SIDED|95.0|-3.9|2.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 48||2.2|-3.9|
72620328|NCT02739828|144771823|SUPERIORITY|||||||0.125|||||||Sign test|||Analysis is under the assumption of completely missing at random (deleted incomplete observations).||||0.1250
72454495|NCT02434328|144432673|OTHER||Difference in proportions|-1.0|||||TWO_SIDED|95.0|-4.3|2.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 52||2.3|-4.3|
72454496|NCT02434328|144432673|OTHER||Difference in proportions|0.6|||||TWO_SIDED|95.0|-2.8|3.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 56||3.9|-2.8|
72454497|NCT02434328|144432673|OTHER||Difference in proportions|0.6|||||TWO_SIDED|95.0|-2.5|4.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 60||4.2|-2.5|
72454498|NCT02434328|144432673|OTHER||Difference in proportions|0.7|||||TWO_SIDED|95.0|-2.7|4.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 64||4.5|-2.7|
72454499|NCT02434328|144432673|OTHER||Difference in proportions|-0.9|||||TWO_SIDED|95.0|-4.2|2.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 68||2.6|-4.2|
72454500|NCT02434328|144432673|OTHER||Difference in proportions|0.9|||||TWO_SIDED|95.0|-2.5|4.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 72||4.5|-2.5|
72454501|NCT02434328|144432673|OTHER||Difference in proportions|0.7|||||TWO_SIDED|95.0|-2.5|4.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 76||4.4|-2.5|
72454502|NCT02434328|144432673|OTHER||Difference in proportions|0.9|||||TWO_SIDED|95.0|-2.4|4.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 80||4.6|-2.4|
72454503|NCT02434328|144432673|OTHER||Difference in proportions|0.2|||||TWO_SIDED|95.0|-3.1|4.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 84||4.1|-3.1|
72454504|NCT02434328|144432673|OTHER||Difference in proportions|-0.2|||||TWO_SIDED|95.0|-3.5|3.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 88||3.6|-3.5|
72454505|NCT02434328|144432673|OTHER||Difference in proportions|-0.4|||||TWO_SIDED|95.0|-3.8|3.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 92||3.3|-3.8|
72454506|NCT02434328|144432673|OTHER||Difference in proportions|-0.4|||||TWO_SIDED|95.0|-3.8|3.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 96||3.3|-3.8|
72454507|NCT02434328|144432674|OTHER||Difference in proportions|-0.5|||||TWO_SIDED|95.0|-2.6|1.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 4||1.6|-2.6|
72454508|NCT02434328|144432674|OTHER||Difference in proportions|0.0|||||TWO_SIDED|95.0|-2.2|2.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 8||2.1|-2.2|
72562619|NCT01077817|144657101|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|4.9|||||TWO_SIDED|95.0|1.4|16.7|||Logistic Regression Model|The case-cohort hazard ratio estimate for drug exposure was based on analysis of all cases of esophageal cancer and their comparison sample.||A hazard ratio estimate was calculated from the case-control matched set to measure the risk association between exposure to ibandronate treatment and incidence of esophageal cancer.||16.7|1.4|
72391806|NCT00256750|144290856|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|0.5||||0.6319|TWO_SIDED|95.0|-1.6|2.6|||ANOVA|Missing data were imputed by LOCF|Missing data were imputed by LOCF|Mental Health, Month 12||2.6|-1.6|0.6319
72454509|NCT02434328|144432674|OTHER||Difference in proportions|-0.3|||||TWO_SIDED|95.0|-2.8|2.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 12||2.2|-2.8|
72454510|NCT02434328|144432674|OTHER||Difference in proportions|-1.4|||||TWO_SIDED|95.0|-4.4|1.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 16||1.7|-4.4|
72454511|NCT02434328|144432674|OTHER||Difference in proportions|1.4|||||TWO_SIDED|95.0|-1.7|4.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 20||4.9|-1.7|
72454512|NCT02434328|144432674|OTHER||Difference in proportions|-0.7|||||TWO_SIDED|95.0|-3.9|2.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 24||2.8|-3.9|
72454513|NCT02434328|144432674|OTHER||Difference in proportions|0.3|||||TWO_SIDED|95.0|-3.2|3.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 28||3.8|-3.2|
72454514|NCT02434328|144432674|OTHER||Difference in proportions|-0.1|||||TWO_SIDED|95.0|-3.8|3.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 32||3.5|-3.8|
72454515|NCT02434328|144432674|OTHER||Difference in proportions|0.3|||||TWO_SIDED|95.0|-3.0|4.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 36||4.2|-3.0|
72454516|NCT02434328|144432674|OTHER||Difference in proportions|1.2|||||TWO_SIDED|95.0|-2.4|5.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 40||5.1|-2.4|
72454517|NCT02434328|144432674|OTHER||Difference in proportions|2.5|||||TWO_SIDED|95.0|-1.1|6.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 44||6.5|-1.1|
72454518|NCT02434328|144432674|OTHER||Difference in proportions|-0.4|||||TWO_SIDED|95.0|-4.0|3.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 48||3.3|-4.0|
72454519|NCT02434328|144432674|OTHER||Difference in proportions|0.9|||||TWO_SIDED|95.0|-2.8|4.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 52||4.7|-2.8|
72499744|NCT00110305|144529547|SUPERIORITY_OR_OTHER||Difference in response rate|0.0||||0.99|TWO_SIDED|95.0|-12.9|12.8||The significance level for each comparison was 5% (two-sided). No further adjustment of this significance level was applied.|Regression, Logistic|This model with factors treatment, region, and N(t)RTIs used, and baseline viral load as covariate.||||12.8|-12.9|0.99
72499745|NCT00110305|144529547|SUPERIORITY_OR_OTHER||Differences in response|2.6||||0.63|TWO_SIDED|95.0|-8.1|13.3||The significance level for each comparison was 5% (two-sided). No further adjustment of this significance level was applied.|Regression, Logistic|This model with factors treatment, region, and N(t)RTIs used, and baseline viral load as covariate.||||13.3|-8.1|0.63
72499746|NCT00110305|144529549|SUPERIORITY_OR_OTHER||Difference in response rate|-2.8||||||95.0|-14.7|9.1||||||||9.1|-14.7|
72391807|NCT00256750|144290856|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|1.8||||0.0503|TWO_SIDED|95.0|0.0|3.7|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Physical Functioning, Month 12||3.7|-0.0|0.0503
72454520|NCT02434328|144432674|OTHER||Difference in proportions|1.2|||||TWO_SIDED|95.0|-2.8|5.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 56||5.5|-2.8|
72454521|NCT02434328|144432674|OTHER||Difference of proportions|1.0|||||TWO_SIDED|95.0|-2.6|4.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 60||4.7|-2.6|
72454522|NCT02434328|144432674|OTHER||Difference in proportions|-0.1|||||TWO_SIDED|95.0|-4.0|4.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 64||4.3|-4.0|
72454523|NCT02434328|144432674|OTHER||Difference in proportions|-0.6|||||TWO_SIDED|95.0|-4.2|3.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 68||3.6|-4.2|
72499747|NCT05067127|144529645|SUPERIORITY||Difference in least squares (LS) mean|-1.143|||<|0.0001|TWO_SIDED|95.0|-1.436|-0.85|||MMRM|||An mixed-effect model for repeated measures (MMRM) including fixed categorical effect for treatment group, visit, disease type, baseline immunosuppressants use, stratification factors, and the visit-by-treatment group interactions as well as the continuous, fixed covariate of baseline log-transformed uPCR, was utilized to analyze the log-transformed ratio of uPCR at Week 26 compared to baseline.||-0.85|-1.436|<0.0001
72499748|NCT05067127|144529646|SUPERIORITY||Odds Ratio (OR)|27.516|||<|0.0001|TWO_SIDED|95.0|6.105|124.026|||Logistic|||The logistic model included treatment group as independent variable and adjusted for baseline eGFR values, baseline log-transformed uPCR values, disease type, and stratification factors.||124.026|6.105|<0.0001
72454524|NCT02434328|144432674|OTHER||Difference in proportions|-0.1|||||TWO_SIDED|95.0|-4.0|3.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 72||3.7|-4.0|
72454525|NCT02434328|144432674|OTHER||Difference in proportions|0.4|||||TWO_SIDED|95.0|-3.5|4.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 76||4.7|-3.5|
72454526|NCT02434328|144432674|OTHER||Difference in proportions|-0.7|||||TWO_SIDED|95.0|-4.5|3.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 80||3.4|-4.5|
72499749|NCT05067127|144529647|SUPERIORITY||Odds Ratio (OR)|30.932|||<|0.0001|TWO_SIDED|95.0|8.401|113.897|||Logistic|||The logistic model included treatment group as independent variable and adjusted for baseline log-transformed uPCR values, disease type, and stratification factors.||113.897|8.401|<0.0001
72499750|NCT05067127|144529648|SUPERIORITY||Difference in LS mean|-1.002||||0.2753|TWO_SIDED|95.0|-2.803|0.798|||ANCOVA|||Analysis of covariance (ANCOVA) model included treatment as fixed effect, adjusted for baseline C3G histologic index activity score, disease type, and stratification factors.||0.798|-2.803|0.2753
72562620|NCT01077817|144657101|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.6|||||TWO_SIDED|95.0|1.0|2.5|||Logistic Regression Model|The case-cohort hazard ratio estimate for drug exposure was based on analysis of all cases of esophageal cancer and their comparison sample.||A hazard ratio estimate was calculated from the case-control matched set to measure the risk association between exposure to risedronate treatment and incidence of esophageal cancer.||2.5|1.0|
72562621|NCT01077817|144657101|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.7|||||TWO_SIDED|95.0|0.2|2.2|||Logistic Regression Model|The case-cohort hazard ratio estimate for drug exposure was based on analysis of all cases of esophageal cancer and their comparison sample.||A hazard ratio estimate was calculated from the case-control matched set to measure the risk association between exposure to raloxifene treatment and incidence of esophageal cancer.||2.2|0.2|
72562622|NCT01077817|144657102|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.0|||||TWO_SIDED|95.0|0.7|1.3|||Proportional Hazards Regression Model|Year of birth, calendar quarter of cohort entry, and exposure history were stratified in this model.||"A hazard ratio was calculated to estimate the risk of esophageal cancer among initiators of alendronate~compared to non-initiators of alendronate. For calculation of this hazard ratio, esophageal cancer cases occurring during the entire follow-up period were used."||1.3|0.7|
72562623|NCT01077817|144657102|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.3|||||TWO_SIDED|95.0|0.8|2.0|||Proportional Hazards Regression Model|Year of birth, calendar quarter of cohort entry, and exposure history were stratified in this model.||"A hazard ratio was calculated to estimate the risk of esophageal cancer among initiators of etidronate~compared to non-initiators of etidronate. For calculation of this hazard ratio, esophageal cancer cases occurring during the entire follow-up period were used."||2.0|0.8|
72562624|NCT01077817|144657102|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.3|||||TWO_SIDED|95.0|0.5|3.4|||Proportional Hazards Regression Model|Year of birth, calendar quarter of cohort entry, and exposure history were stratified in this model.||"A hazard ratio was calculated to estimate the risk of esophageal cancer among initiators of ibandronate~compared to non-initiators of ibandronate. For calculation of this hazard ratio, esophageal cancer cases occurring during the entire follow-up period were used."||3.4|0.5|
72562625|NCT01077817|144657102|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.3|||||TWO_SIDED|95.0|0.9|2.0|||Proportional Hazards Regression Model|Year of birth, calendar quarter of cohort entry, and exposure history were stratified in this model.||"A hazard ratio was calculated to estimate the risk of esophageal cancer among initiators of risendronate~compared to non-initiators of risendronate. For calculation of this hazard ratio, esophageal cancer cases occurring during the entire follow-up period were used."||2.0|0.9|
72562626|NCT01077817|144657102|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.9|||||TWO_SIDED|95.0|0.3|2.3|||Proportional Hazards Regression Model|Year of birth, calendar quarter of cohort entry, and exposure history were stratified in this model.||"A hazard ratio was calculated to estimate the risk of esophageal cancer among initiators of raloxifene~compared to non-initiators of raloxifene. For calculation of this hazard ratio, esophageal cancer cases occurring during the entire follow-up period were used."||2.3|0.3|
72391808|NCT00256750|144290856|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|0.9||||0.3291|TWO_SIDED|95.0|-0.9|2.8|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Physical Functioning, Month 12||2.8|-0.9|0.3291
72454527|NCT02434328|144432674|OTHER||Difference in proportions|0.2|||||TWO_SIDED|95.0|-3.6|4.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 84||4.5|-3.6|
72499751|NCT05067127|144529649|SUPERIORITY||Odds Ratio (OR)|27.392|||<|0.0001|TWO_SIDED|95.0|6.477|115.852|||Logistic|||The logistic model included treatment group as independent variable and adjusted for baseline C3c staining, disease type, and stratification factors.||115.852|6.477|<0.0001
72620329|NCT01953354|144771825|SUPERIORITY_OR_OTHER|||||||1||||||P-value is testing for a difference in proportions using a Fisher's exact test.|Fisher Exact|||||||1.000
72620330|NCT01953354|144771826|SUPERIORITY_OR_OTHER|||||||1||||||P-value is testing for a difference in proportions using a Fisher's exact test.|Fisher Exact|||||||1.000
72620331|NCT01953354|144771827|SUPERIORITY_OR_OTHER|||||||0.242||||||P-value is testing for a difference in proportions using a Fisher's exact test.|Fisher Exact|||||||0.242
72620332|NCT01953354|144771828|SUPERIORITY_OR_OTHER|||||||0.55||||||P-value is testing for a difference in proportions using a Fisher's exact test.|Fisher Exact|||||||0.550
72620333|NCT01953354|144771831|SUPERIORITY_OR_OTHER|||||||0.55||||||P-value is testing for a difference in proportions using a Fisher's exact test.|Fisher Exact|||||||0.550
72620334|NCT01953354|144771832|SUPERIORITY_OR_OTHER|||||||0.633||||||P-value is testing for a difference in proportions using a Fisher's exact test.|Fisher Exact|||||||0.633
72454528|NCT02434328|144432674|OTHER||Difference in proportions|-0.7|||||TWO_SIDED|95.0|-4.5|3.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 88||3.6|-4.5|
72454529|NCT02434328|144432674|OTHER||Difference in proportions|-1.8|||||TWO_SIDED|95.0|-5.7|2.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 92||2.6|-5.7|
72562627|NCT01077817|144657102|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.0|||||TWO_SIDED|95.0|0.7|1.5|||Proportional Hazards Regression Model|||"A hazard ratio was calculated to estimate the risk of esophageal cancer among initiators of~alendronate compared to non-initiators of alendronate. For calculation of 721+ day hazard ratios, only esophageal cancer cases occurring at least 721 days from initiation of study drug (data not shown) were used."||1.5|0.7|
72562628|NCT01077817|144657102|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.2|||||TWO_SIDED|95.0|0.7|1.9|||Proportional Hazards Regression Model|||"A hazard ratio was calculated to estimate the risk of esophageal cancer among initiators of~etidronate compared to non-initiators of etidronate. For calculation of 721+ day hazard ratios, only~esophageal cancer cases occurring at least 721 days from initiation of study drug (data not shown) were used."||1.9|0.7|
72562629|NCT01077817|144657102|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|3.0|||||TWO_SIDED|95.0|0.8|11.1|||Proportional Hazards Regression Model|||"A hazard ratio was calculated to estimate the risk of esophageal cancer among initiators of~ibandronate compared to non-initiators of ibandronate. For calculation of 721+ day hazard ratios,~only esophageal cancer cases occurring at least 721 days from initiation of study drug (data not shown) were used."||11.1|0.8|
72562630|NCT01077817|144657102|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.8|||||TWO_SIDED|95.0|1.1|3.0|||Proportional Hazards Regression Model|||"A hazard ratio was calculated to estimate the risk of esophageal cancer among initiators of~risedronate compared to non-initiators of risedronate. For calculation of 721+ day hazard ratios,~only esophageal cancer cases occurring at least 721 days from initiation of study drug (data not shown) were used."||3.0|1.1|
72562631|NCT01077817|144657102|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.6|||||TWO_SIDED|95.0|0.1|2.7|||Proportional Hazards Regression Model|||"A hazard ratio was calculated to estimate the risk of esophageal cancer among initiators of~raloxifene compared to non-initiators of raloxifene. For calculation of 721+ day hazard ratios, only~esophageal cancer cases occurring at least 721 days from initiation of study drug (data not shown) were used."||2.7|0.1|
72562632|NCT01077817|144657102|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.9|||||TWO_SIDED|95.0|0.5|1.6|||Proportional Hazards Regression Model|Year of birth, calendar quarter of cohort entry, and exposure history were stratified in this model.||"A hazard ratio was calculated to estimate the risk of esophageal cancer among initiators of alendronate~compared to non-initiators of alendronate. For calculation of 1441+ day hazard ratios, only esophageal cancer cases occurring at least 1441 days from initiation of study drug (data not shown) were used."||1.6|0.5|
72562633|NCT01077817|144657102|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.1|||||TWO_SIDED|95.0|0.6|2.0||Year of birth, calendar quarter of cohort entry, and exposure history were stratified in this model.|Proportional hazards regression model|||"A hazard ratio was calculated to estimate the risk of esophageal cancer among initiators of etidronate~compared to non-initiators of etidronate. For calculation of 1441+ day hazard ratios, only esophageal cancer cases occurring at least 1441 days from initiation of study drug (data not shown) were used."||2.0|0.6|
72562634|NCT01077817|144657102|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.0|||||TWO_SIDED|95.0|0.4|2.5|||Proportional hazards regression model|Year of birth, calendar quarter of cohort entry, and exposure history were stratified in this model.||"A hazard ratio was calculated to estimate the risk of esophageal cancer among initiators of risedronate~compared to non-initiators of risedronate. For calculation of 1441+ day hazard ratios, only esophageal cancer cases occurring at least 1441 days from initiation of study drug (data not shown) were used."||2.5|0.4|
72562635|NCT01077817|144657102|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.8|||||TWO_SIDED|95.0|0.2|3.9|||Proportional hazards regression model|Year of birth, calendar quarter of cohort entry, and exposure history were stratified in this model.||"A hazard ratio was calculated to estimate the risk of esophageal cancer among initiators of raloxifene~compared to non-initiators of raloxifene. For calculation of 1441+ day hazard ratios, only esophageal cancer cases occurring at least 1441 days from initiation of study drug (data not shown) were used."||3.9|0.2|
72562636|NCT03750695|144657104|OTHER||||||<|0.05|||||||Regression, Linear|||Repeated measures linear regression||||<0.05
72562637|NCT04480307|144657130|SUPERIORITY||LS Mean Difference|-0.031||||0.5084|TWO_SIDED|95.0|-0.124|0.063|||ANCOVA|||||0.063|-0.124|0.5084
72562638|NCT04480307|144657130|SUPERIORITY||Difference of change from Baseline|-0.021|||||TWO_SIDED|95.0|-0.121|0.057|||Bayesian|Difference of change from baseline a posteriori||Bayesian analysis is done using a non-informative prior on the mean observed difference.||0.057|-0.121|
72562639|NCT04480307|144657131|SUPERIORITY||LS Mean Difference|-0.002||||0.9472|TWO_SIDED|95.0|-0.052|0.049|||ANCOVA|||||0.049|-0.052|0.9472
72562640|NCT04480307|144657131|SUPERIORITY||Difference of change from Baseline|0.012|||||TWO_SIDED|95.0|-0.036|0.059|||Bayesian|Difference of change from Baseline a posteriori.||Bayesian analysis is done using a non-informative prior on the mean observed difference.||0.059|-0.036|
72562641|NCT04480307|144657132|SUPERIORITY||LS Mean Difference|0.154||||0.4027|TWO_SIDED|95.0|-0.216|0.524|||ANCOVA|||ANCOVA analysis for T1 lesion volume parameter||0.524|-0.216|0.4027
72562642|NCT04480307|144657132|SUPERIORITY||LS Mean Difference|0.01||||0.7428|TWO_SIDED|95.0|-0.051|0.071|||ANCOVA|||ANCOVA analysis for T2 lesion volume parameter||0.071|-0.051|0.7428
72454530|NCT02434328|144432674|OTHER||Difference in proportions|-1.0|||||TWO_SIDED|95.0|-4.9|3.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 96||3.2|-4.9|
72454531|NCT02434328|144432675|OTHER||Difference in proportions|-0.2|||||TWO_SIDED|95.0|-3.5|3.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 4||3.5|-3.5|
72454532|NCT02434328|144432675|OTHER||Difference in proportions|-0.5|||||TWO_SIDED|95.0|-4.4|3.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 8||3.4|-4.4|
72454533|NCT02434328|144432675|OTHER||Difference in proportions|-1.0|||||TWO_SIDED|95.0|-5.0|3.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 12||3.1|-5.0|
72454534|NCT02434328|144432675|OTHER||Difference in proportions|1.9|||||TWO_SIDED|95.0|-1.9|6.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 16||6.2|-1.9|
72454535|NCT02434328|144432675|OTHER||Difference in proportions|3.7|||||TWO_SIDED|95.0|-0.4|7.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 20||7.8|-0.4|
72454536|NCT02434328|144432675|OTHER||Difference in proportions|3.1|||||TWO_SIDED|95.0|-1.3|7.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Number of subjects with \>=5 letter loss from baseline in BCVA (letters read) at each post-baseline visit - Week 24||7.8|-1.3|
72499752|NCT05067127|144529650|SUPERIORITY||Difference in LS mean|6.312||||0.0333|TWO_SIDED|95.0|0.501|12.122|||MMRM|||An MMRM model included fixed categorical effect for treatment group, visit, disease type, stratification factors, and the visit-by-treatment group interactions as well as the continuous, fixed covariate of baseline eGFR, was utilized to analyze the mean change from baseline to Week 26 in eGFR.||12.122|0.501|0.0333
72454537|NCT02434328|144432675|OTHER||Difference in proportions|2.6|||||TWO_SIDED|95.0|-1.7|7.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 28||7.3|-1.7|
72454538|NCT02434328|144432675|OTHER||Difference in proportions|1.2|||||TWO_SIDED|95.0|-3.2|5.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 32||5.9|-3.2|
72454539|NCT02434328|144432675|OTHER||Difference in proportions|3.4|||||TWO_SIDED|95.0|-0.7|8.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 36||8.3|-0.7|
72454540|NCT02434328|144432675|OTHER||Difference in proportions|1.0|||||TWO_SIDED|95.0|-3.8|5.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 40||5.6|-3.8|
72499753|NCT05067127|144529651|SUPERIORITY||Odds Ratio (OR)|5.753||||0.0006|TWO_SIDED|95.0|2.106|15.716|||Logistic|||The logistic model included treatment group as independent variable and adjusted for baseline proteinuria values, disease type, and stratification factors.||15.716|2.106|0.0006
72391809|NCT00256750|144290856|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|1.0||||0.386|TWO_SIDED|95.0|-1.2|3.1|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Role Emotional, Month 12||3.1|-1.2|0.3860
72454541|NCT02434328|144432675|OTHER||Difference in proportions|2.9|||||TWO_SIDED|95.0|-1.4|7.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 44||7.0|-1.4|
72454542|NCT02434328|144432675|OTHER||Difference in proportions|-0.7|||||TWO_SIDED|95.0|-5.1|3.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 48||3.7|-5.1|
72454543|NCT02434328|144432675|OTHER||Difference in proportions|2.1|||||TWO_SIDED|95.0|-2.5|6.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 52||6.7|-2.5|
72499754|NCT05067127|144529652|SUPERIORITY||Odds Ratio (OR)|88.341||||0.0001|TWO_SIDED|95.0|8.863|880.544|||Logistic|||The logistic model included treatment group as independent variable and adjusted for baseline albumin values, disease type, and stratification factors.||880.544|8.863|0.0001
72562643|NCT04480307|144657133|SUPERIORITY||LS Mean Difference|0.003||||0.7314|TWO_SIDED|95.0|-0.013|0.018|||ANCOVA|||||0.018|-0.013|0.7314
72454544|NCT02434328|144432675|OTHER||Difference in proportions|1.8|||||TWO_SIDED|95.0|-2.8|6.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 56||6.4|-2.8|
72454545|NCT02434328|144432675|OTHER||Difference in proportions|1.2|||||TWO_SIDED|95.0|-3.6|5.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 60||5.8|-3.6|
72454546|NCT02434328|144432675|OTHER||Difference in proportions|0.5|||||TWO_SIDED|95.0|-4.0|5.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 64||5.4|-4.0|
72454547|NCT02434328|144432675|OTHER||Difference in proportions|1.8|||||TWO_SIDED|95.0|-2.8|6.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 68||6.4|-2.8|
72454548|NCT02434328|144432675|OTHER||Difference in proportions|0.7|||||TWO_SIDED|95.0|-4.3|5.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 72||5.7|-4.3|
72562644|NCT04480307|144657133|SUPERIORITY||Difference of change from Baseline|0.005|||||TWO_SIDED|95.0|-0.01|0.023|||Bayesian|Difference of change from Baseline a posteriori||Bayesian analysis is done using a non-informative prior on the mean observed difference.||0.023|-0.010|
72562645|NCT04480307|144657134|SUPERIORITY||LS Mean Difference|0.0||||0.7662|TWO_SIDED|95.0|0.0|0.0|||ANCOVA|||||0|0|0.7662
72562646|NCT02010996|144657151|SUPERIORITY_OR_OTHER|||||||0.05|TWO_SIDED||||||Chi-squared|||||||0.05
72562647|NCT05103657|144657152|OTHER||Mean Difference (Net)|0.06||||0.9726|TWO_SIDED|95.0|-3.31|3.43|||Mixed Models for repeated measures||"Least Squares mean of BI 1358894 125 mg - Least Square mean of Placebo."|Least Squares (LS) means differences and confidence intervals were estimated by REML-based MMRM including the fixed categorical covariates of treatment, and the stratification indicator of presence of significant childhood trauma (yes vs. no), the continuous fixed covariate of baseline CAPS-5 total severity score, time since index event (in years) and the treatment-by-visit interaction. Patient is considered as random. Unstructured covariance matrix was used.||3.43|-3.31|0.9726
72562648|NCT05103657|144657153|OTHER||Odds Ratio (OR)|1.002||||0.9945|TWO_SIDED|95.0|0.608|1.65|||Regression, Logistic||BI 1358894 125 mg vs. Placebo|Logistic regression was adjusted for fixed factors of treatment and presence of significant childhood trauma (yes vs. no).||1.650|0.608|0.9945
72562649|NCT05103657|144657154|OTHER||Odds Ratio (OR)|0.912||||0.7167|TWO_SIDED|95.0|0.552|1.504|||Regression, Logistic||BI 1358894 125 mg vs. Placebo|Logistic regression was adjusted for fixed factors of treatment and presence of significant childhood trauma (yes vs. no).||1.504|0.552|0.7167
72562650|NCT05103657|144657155|OTHER||Mean Difference (Net)|0.66||||0.723|TWO_SIDED|95.0|-3.0|4.32|||Mixed Models for Repeated Measures||"Least Square mean of BI 1358894 125 mg - Least Square mean of Placebo."|Least Square (LS) means differences and confidence intervals were estimated by REML-based MMRM including the fixed categorical covariates of treatment, and the stratification indicator of presence of significant childhood trauma (yes vs. no), the continuous fixed covariate of baseline CAPS-5 total severity score, time since index event (in years) and the treatment-by-visit interaction. Patient is considered as random. Unstructured covariance matrix was used.||4.32|-3.00|0.7230
72454549|NCT02434328|144432675|OTHER||Difference in proportions|0.7|||||TWO_SIDED|95.0|-4.4|5.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 76||5.8|-4.4|
72391810|NCT00256750|144290856|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|0.0||||0.9672|TWO_SIDED|95.0|-2.2|2.3|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Role Emotional, Month 12||2.3|-2.2|0.9672
72454550|NCT02434328|144432675|OTHER||Difference in proportions|-1.2|||||TWO_SIDED|95.0|-6.0|3.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 80||3.6|-6.0|
72562651|NCT03635983|144657161|SUPERIORITY||Estimate of Odds Ratio (OR)|0.66||||0.0311|TWO_SIDED|95.0|0.45|0.96|||Stratified Cochran-Mantel-Haenszel|two-sided|Strata adjusted odds ratio (NKTR-214 + Nivolumab over Nivolumab) using Mantel-Haenszel method.|Bempegaldesleukin+Nivolumab over Nivolumab||0.96|0.45|0.0311
72562652|NCT03635983|144657162|SUPERIORITY||Hazard Ratio (HR)|1.09||||0.3988||95.0|0.89|1.33||Log-rank stratified 2-sided. Boundary for statistical significance p-value \< 0.03|Log Rank||Stratified Cox proportional hazard model. Hazard Ratio is NKTR-214 + Nivolumab over Nivolumab|||1.33|0.89|0.3988
72562653|NCT03635983|144657163|SUPERIORITY|Bempegaldesleukin+Nivolumab over Nivolumab|Hazard Ratio (HR)|0.94||||0.6361|TWO_SIDED|95.0|0.72|1.22|||Log Rank|2-sided p-value. Boundary for statistical significance p-value \< 0.00071|Stratified Cox proportional hazard model. Hazard Ratio is NKTR-214 + Nivolumab over Nivolumab.|||1.22|0.72|0.6361
72620335|NCT00806026|144771847|SUPERIORITY_OR_OTHER_LEGACY||Least squares (LS) mean difference|-4.5|STANDARD_ERROR_OF_MEAN|0.67|<|0.0001|TWO_SIDED|95.0|-5.9|-3.2||This analysis was step 1 in a step-down procedure (if p\<0.05, then continue to next step) used to control the Type I error rate. This procedure was stopped at Step 6. The analysis was done at a significance level of alpha = 0.05, 2-sided.|Mixed Models Analysis|Spatial power covariance structure was used.||For pregabalin 300 mg versus placebo: Mixed model analysis was used to analyze RLS symptom severity score with baseline value, region \[United states (US) or European union (EU)\], treatment, week and treatment by week interaction as fixed effects.||-3.20|-5.90|<0.0001
72620336|NCT00806026|144771847|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.68||0.3603|TWO_SIDED|95.0|-2.0|0.7||This analysis was not included in the step-down procedure (if p\<0.05, then continue to next step) to control Type I error. The analysis was done at a significance level of alpha = 0.05, 2-sided.|Mixed Models Analysis|Spatial power covariance structure was used.||For pramipexole 0.25 mg versus placebo: Mixed model analysis was used to analyze RLS symptom severity score with baseline value, region (US or EU), treatment, week and treatment by week interaction as fixed effects.||0.7|-2.0|0.3603
72620337|NCT00806026|144771847|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-3.2|STANDARD_ERROR_OF_MEAN|0.67|<|0.0001|TWO_SIDED|95.0|-4.5|-1.9||This analysis was not included in the step-down procedure (if p\<0.05, then continue to next step) to control Type I error. The analysis was done at a significance level of alpha = 0.05, 2-sided.|Mixed Models Analysis|Spatial power covariance structure was used.||For pramipexole 0.5 mg versus placebo: Mixed model analysis was used to analyze RLS symptom severity score with baseline value, region (US or EU), treatment, week and treatment by week interaction as fixed effects.||-1.9|-4.5|<0.0001
72620338|NCT00806026|144771848|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED|||||This analysis was step 2 in a step-down procedure (if p\<0.05, then continue to next step) used to control the Type I error rate. This procedure was stopped at Step 6. The analysis was done at a significance level of alpha = 0.05, 2-sided.|Cochran-Mantel-Haenszel|||For pregabalin 300 mg versus placebo: Cochran-Mantel-Haenszel (CMH) test stratified by geographical region (US or EU) was used to analyze CGI-I responder status.||||<0.0001
72620339|NCT00806026|144771848|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4393|TWO_SIDED|||||This analysis was not included in the step-down procedure (if p\<0.05, then continue to next step) to control Type I error. The analysis was done at a significance level of alpha = 0.05, 2-sided.|Cochran-Mantel-Haenszel|||For pramipexole 0.25 mg versus placebo: CMH test stratified by geographical region (US or EU) was used to analyze CGI-I responder status.||||0.4393
72620340|NCT00806026|144771848|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0022|TWO_SIDED|||||This analysis was not included in the step-down procedure (if p\<0.05, then continue to next step) to control Type I error. The analysis was done at a significance level of alpha = 0.05, 2-sided.|Cochran-Mantel-Haenszel|||For pramipexole 0.5 mg versus placebo: CMH test stratified by geographical region (US or EU) was used to analyze CGI-I responder status.||||0.0022
72620341|NCT00806026|144771849|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0826|TWO_SIDED|||||This analysis was step 6 in a step-down procedure (if p\<0.05, then continue to next step) used to control the Type I error rate. This procedure was stopped at Step 6. The analysis was done at a significance level of alpha = 0.05, 2-sided.|Log Rank|||For pramipexole 0.25 mg versus pregabalin 300 mg: Stratified log rank test by block (40 weeks versus 52 weeks of active treatment) was used to calculate p-value.||||0.0826
72620342|NCT00806026|144771849|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0012|TWO_SIDED|||||This analysis was step 3 in a step-down procedure (if p\<0.05, then continue to next step) used to control the Type I error rate. This procedure was stopped at Step 6. The analysis was done at a significance level of alpha = 0.05, 2-sided.|Log Rank|||For pramipexole 0.5 mg versus pregabalin 300 mg: Stratified log rank test by block (40 weeks versus 52 weeks of active treatment) was used to calculate p-value.||||0.0012
72454551|NCT02434328|144432675|OTHER||Difference in proportions|-0.4|||||TWO_SIDED|95.0|-5.2|4.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 84||4.5|-5.2|
72620343|NCT00806026|144771851|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-17.25|STANDARD_ERROR_OF_MEAN|4.332|<|0.0001|TWO_SIDED|95.0|-25.76|-8.74||This analysis was step 7 in a step-down procedure (if p\<0.05, then continue to next step) used to control the Type I error rate. This procedure was stopped at Step 6. The analysis was done at a significance level of alpha = 0.05, 2-sided.|Mixed Models Analysis|Spatial power covariance structure was used.||For pregabalin 300 mg versus placebo: Mixed model analysis was used to analyze SSQ-Subjective WASO score with baseline value, region (US or EU), treatment, week and treatment by week interaction as fixed effects.||-8.74|-25.76|<0.0001
72620344|NCT00806026|144771851|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.07|STANDARD_ERROR_OF_MEAN|4.408||0.8075|TWO_SIDED|95.0|-9.73|7.58||This analysis was not included in the step-down procedure (if p\<0.05, then continue to next step) to control Type I error. The analysis was done at a significance level of alpha = 0.05, 2-sided.|Mixed Models Analysis|Spatial power covariance structure was used.||For pramipexole 0.25 mg versus placebo: Mixed model analysis was used to analyze SSQ-Subjective WASO score with baseline value, region (US or EU), treatment, week and treatment by week interaction as fixed effects.||7.58|-9.73|0.8075
72454552|NCT02434328|144432675|OTHER||Difference in proportions|-1.2|||||TWO_SIDED|95.0|-5.7|3.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 88||3.6|-5.7|
72499755|NCT05067127|144529653|SUPERIORITY||Odds Ratio (OR)|999.999||||0.0094|TWO_SIDED|95.0|12.175|9999.999|||Logistic|||The logistic model included treatment group as independent variable and adjusted for baseline C3 levels, stratification factors and disease type.||9999.999|12.175|0.0094
72391811|NCT00256750|144290856|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|2.1||||0.0392|TWO_SIDED|95.0|0.1|4.1|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Role-Physical, Month 12||4.1|0.1|0.0392
72454553|NCT02434328|144432675|OTHER||Difference in proportions|-1.5|||||TWO_SIDED|95.0|-6.5|3.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 92||3.4|-6.5|
72454554|NCT02434328|144432675|OTHER||Difference in proportions|-0.1|||||TWO_SIDED|95.0|-5.1|4.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 96||4.8|-5.1|
72454555|NCT02434328|144432676|OTHER||Difference in proportions|-4.0|||||TWO_SIDED|95.0|-9.2|1.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 4||1.6|-9.2|
72454556|NCT02434328|144432676|OTHER||Difference in proportions|-2.1|||||TWO_SIDED|95.0|-8.1|3.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 8||3.7|-8.1|
72454557|NCT02434328|144432676|OTHER||Difference in proportions|-2.5|||||TWO_SIDED|95.0|-8.4|3.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 12||3.5|-8.4|
72454558|NCT02434328|144432676|OTHER||Difference in proportions|0.3|||||TWO_SIDED|95.0|-5.4|6.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 16||6.7|-5.4|
72454559|NCT02434328|144432676|OTHER||Difference in proportions|-2.2|||||TWO_SIDED|95.0|-8.2|4.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 20||4.0|-8.2|
72454560|NCT02434328|144432676|OTHER||Difference in proportions|-3.1|||||TWO_SIDED|95.0|-9.0|3.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 24||3.3|-9.0|
72454561|NCT02434328|144432676|OTHER||Difference in proportions|-3.2|||||TWO_SIDED|95.0|-9.3|2.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 28||2.5|-9.3|
72454562|NCT02434328|144432676|OTHER||Difference in proportions|-3.1|||||TWO_SIDED|95.0|-9.6|2.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 32||2.8|-9.6|
72454563|NCT02434328|144432676|OTHER||Difference in proportions|-3.7|||||TWO_SIDED|95.0|-9.6|2.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 36||2.2|-9.6|
72454564|NCT02434328|144432676|OTHER||Difference in proportions|-1.7|||||TWO_SIDED|95.0|-7.6|4.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 40||4.2|-7.6|
72454565|NCT02434328|144432676|OTHER||Difference in proportions|-1.4|||||TWO_SIDED|95.0|-7.5|5.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 44||5.0|-7.5|
72499756|NCT05067127|144529654|SUPERIORITY||Difference in LS mean|0.562||||0.7384|TWO_SIDED|95.0|-2.739|3.863|||ANCOVA|||The ANCOVA model included treatment as fixed effect, adjusted for baseline, disease type, and stratification factors.||3.863|-2.739|0.7384
72454566|NCT02434328|144432676|OTHER||Difference in proportions|0.4|||||TWO_SIDED|95.0|-5.4|6.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 48||6.1|-5.4|
72454567|NCT02434328|144432676|OTHER||Difference in proportions|-1.8|||||TWO_SIDED|95.0|-7.7|4.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 52||4.5|-7.7|
72499757|NCT05067127|144529655|SUPERIORITY||Difference in LS mean|1.345||||0.5648|TWO_SIDED|95.0|-3.237|5.927|||ANCOVA|||The ANCOVA model included treatment as fixed effect, adjusted for baseline, disease type, and stratification factors.||5.927|-3.237|0.5648
72620345|NCT00806026|144771851|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-4.57|STANDARD_ERROR_OF_MEAN|4.318||0.2906|TWO_SIDED|95.0|-13.05|3.91||This analysis was not included in the step-down procedure (if p\<0.05, then continue to next step) to control Type I error. The analysis was done at a significance level of alpha = 0.05, 2-sided.|Mixed Models Analysis|Spatial power covariance structure was used.||For pramipexole 0.5 mg versus placebo: Mixed model analysis was used to analyze SSQ-Subjective WASO score with baseline value, region (US or EU), treatment, week and treatment by week interaction as fixed effects.||3.91|-13.05|0.2906
72454568|NCT02434328|144432676|OTHER||Difference in proportions|-1.9|||||TWO_SIDED|95.0|-7.7|4.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 56||4.0|-7.7|
72454569|NCT02434328|144432676|OTHER||Difference in proportions|-4.7|||||TWO_SIDED|95.0|-10.8|1.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 60||1.4|-10.8|
72454570|NCT02434328|144432676|OTHER||Difference in proportions|-2.8|||||TWO_SIDED|95.0|-8.9|3.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 64||3.2|-8.9|
72454571|NCT02434328|144432676|OTHER||Difference in proportions|-3.1|||||TWO_SIDED|95.0|-9.5|2.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 68||2.9|-9.5|
72454572|NCT02434328|144432676|OTHER||Difference in proportions|-1.6|||||TWO_SIDED|95.0|-7.9|4.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 72||4.5|-7.9|
72454573|NCT02434328|144432676|OTHER||Difference in proportions|-2.0|||||TWO_SIDED|95.0|-8.1|4.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 76||4.1|-8.1|
72454574|NCT02434328|144432676|OTHER||Difference in proportions|0.5|||||TWO_SIDED|95.0|-5.6|6.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 80||6.6|-5.6|
72454575|NCT02434328|144432676|OTHER||Difference in proportions|-2.4|||||TWO_SIDED|95.0|-8.3|3.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 84||3.8|-8.3|
72454576|NCT02434328|144432676|OTHER||Difference in proportions|-1.3|||||TWO_SIDED|95.0|-7.4|4.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 88||4.5|-7.4|
72454577|NCT02434328|144432676|OTHER||Difference in proportions|-0.5|||||TWO_SIDED|95.0|-6.5|5.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 92||5.8|-6.5|
72454578|NCT02434328|144432676|OTHER||Difference in proportions|-2.0|||||TWO_SIDED|95.0|-8.1|4.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 96||4.1|-8.1|
72391812|NCT00256750|144290856|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|2.5||||0.0151|TWO_SIDED|95.0|0.5|4.5|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Role-Physical, Month 12||4.5|0.5|0.0151
72454579|NCT02434328|144432677|OTHER|Treatment difference|Least Squares Mean Difference|-17.7|STANDARD_ERROR_OF_MEAN|7.57|||TWO_SIDED|95.0|-32.6|-2.9||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 4||-2.9|-32.6|
72454580|NCT02434328|144432677|OTHER|Treatment difference|Least Squares Mean Difference|-29.5|STANDARD_ERROR_OF_MEAN|8.18|||TWO_SIDED|95.0|-45.6|-13.4||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 8||-13.4|-45.6|
72454581|NCT02434328|144432677|OTHER|Treatment difference|Least Squares Mean Difference|-30.3|STANDARD_ERROR_OF_MEAN|8.45|||TWO_SIDED|95.0|-46.9|-13.7||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 12||-13.7|-46.9|
72454582|NCT02434328|144432677|OTHER|Treatment difference|Least Squares Mean Difference|-40.2|STANDARD_ERROR_OF_MEAN|9.51|||TWO_SIDED|95.0|-58.9|-21.6||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 16||-21.6|-58.9|
72454583|NCT02434328|144432677|OTHER|Treatment difference|Least Squares Mean Difference|-2.9|STANDARD_ERROR_OF_MEAN|9.12|||TWO_SIDED|95.0|-20.9|15.0||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 20||15.0|-20.9|
72499758|NCT01499173|144529661|SUPERIORITY||||||<|0.01||||||Actual p value shown here; not threshold.|multilevel linear regression|||||||<0.01
72454584|NCT02434328|144432677|OTHER|Treatment difference|Least Squares Mean Difference|-47.8|STANDARD_ERROR_OF_MEAN|9.42|||TWO_SIDED|95.0|-66.3|-29.3||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 24||-29.3|-66.3|
72454585|NCT02434328|144432677|OTHER|Treatment difference|Least Squares Mean Difference|-23.7|STANDARD_ERROR_OF_MEAN|9.34|||TWO_SIDED|95.0|-42.0|-5.4||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 28||-5.4|-42.0|
72454586|NCT02434328|144432677|OTHER|Treatment difference|Least Squares Mean Difference|-33.7|STANDARD_ERROR_OF_MEAN|9.54|||TWO_SIDED|95.0|-52.4|-15.0||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 32||-15.0|-52.4|
72454587|NCT02434328|144432677|OTHER|Treatment difference|Least Squares Mean Difference|-30.4|STANDARD_ERROR_OF_MEAN|8.94|||TWO_SIDED|95.0|-48.0|-12.9||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 36||-12.9|-48.0|
72454588|NCT02434328|144432677|OTHER|Treatment difference|Least Squares Mean Difference|-44.7|STANDARD_ERROR_OF_MEAN|9.57|||TWO_SIDED|95.0|-63.5|-25.9||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 40||-25.9|-63.5|
72454589|NCT02434328|144432677|OTHER|Treatment difference|Least Squares Mean Difference|-19.2|STANDARD_ERROR_OF_MEAN|9.24|||TWO_SIDED|95.0|-37.3|-1.1||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 44||-1.1|-37.3|
72454590|NCT02434328|144432677|OTHER|Treatment difference|Least Squares Mean Difference|-49.9|STANDARD_ERROR_OF_MEAN|9.68|||TWO_SIDED|95.0|-68.9|-30.9||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 48||-30.9|-68.9|
72454591|NCT02434328|144432677|OTHER|Treatment difference|Least Squares Mean Difference|-28.1|STANDARD_ERROR_OF_MEAN|9.01|||TWO_SIDED|95.0|-45.8|-10.4||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 52||-10.4|-45.8|
72499759|NCT01499173|144529662|SUPERIORITY|||||||0.34|||||||multilevel linear regression|||||||0.34
72499760|NCT01499173|144529663|OTHER|odds ratio|Odds Ratio (OR)|-0.5|||||TWO_SIDED|||||||||Odds ratio was calculated for each question comparing 1 week data with 1 month data||||
72499761|NCT03619213|144529720|SUPERIORITY||Hazard Ratio (HR)|0.82||||0.0008|TWO_SIDED|95.0|0.73|0.92|||Regression, Cox|Stratified by Type 2 Diabetes status at randomization.||Comparison Group: Placebo||0.92|0.73|0.0008
72499762|NCT03619213|144529721|SUPERIORITY||Hazard Ratio (HR)|0.83||||0.0085|TWO_SIDED|95.0|0.73|0.95|||Regression, Cox|Stratified by Type 2 Diabetes status at randomization.||Comparison Group: Placebo||0.95|0.73|0.0085
72620346|NCT00806026|144771857|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.5|STANDARD_ERROR_OF_MEAN|3.93||0.7073|TWO_SIDED|95.0|-9.3|6.3||This analysis was step 8 in a step-down procedure (if p\<0.05, then continue to next step) used to control the Type I error rate. This procedure was stopped at Step 6. The analysis was done at a significance level of alpha = 0.05, 2-sided.|Mixed Models Analysis|Spatial power covariance structure was used.||For pregabalin 300 mg versus placebo: Mixed model analysis was used to analyze RLS-NDI with baseline value, region (US or EU), treatment, week and treatment by week interaction as fixed effects.||6.30|-9.30|0.7073
72454592|NCT02434328|144432677|OTHER|Treatment difference|Least Squares Mean Difference|-43.1|STANDARD_ERROR_OF_MEAN|9.86|||TWO_SIDED|95.0|-62.4|-23.7||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 56||-23.7|-62.4|
72454593|NCT02434328|144432677|OTHER|Treatment difference|Least Squares Mean Difference|-31.1|STANDARD_ERROR_OF_MEAN|9.34|||TWO_SIDED|95.0|-49.5|-12.8||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 60||-12.8|-49.5|
72454594|NCT02434328|144432677|OTHER|Treatment difference|Least Squares Mean Difference|-45.8|STANDARD_ERROR_OF_MEAN|9.7|||TWO_SIDED|95.0|-64.9|-26.8||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 64||-26.8|-64.9|
72454595|NCT02434328|144432677|OTHER|Treatment difference|Least Squares Mean Difference|-23.7|STANDARD_ERROR_OF_MEAN|9.31|||TWO_SIDED|95.0|-42.0|-5.4||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 68||-5.4|-42.0|
72499763|NCT03619213|144529722|SUPERIORITY||Rate Ratio (RR)|0.77||||0.0003|TWO_SIDED|95.0|0.67|0.89|||LWYY proportional rates model|Stratified by Type 2 Diabetes status at randomization||Comparison Group: Placebo||0.89|0.67|0.0003
72499764|NCT03619213|144529723|SUPERIORITY||Rate Ratio (RR)|0.77||||0.0017|TWO_SIDED|95.0|0.65|0.9|||LWYY proportional rates model|Stratified by Type 2 Diabetes status at randomization||Comparison Group: Placebo||0.90|0.65|0.0017
72499765|NCT03619213|144529724|SUPERIORITY||Rate Ratio (RR)|1.11||||0.0086|TWO_SIDED|95.0|1.03|1.21||The p-value is obtained from a rank ANCOVA adjusted for baseline KCCQ score, stratified by T2DM status at randomisation.|Win Ratio|Stratified by Type 2 Diabetes status at randomization and including baseline score as a covariate.|The composite of change from baseline in KCCQ Total Symptom Score at 8 months, or death before 8 months.|Comparison Group: Placebo||1.21|1.03|0.0086
72499766|NCT03619213|144529725|SUPERIORITY||Hazard Ratio (HR)|0.88||||0.1678|TWO_SIDED|95.0|0.74|1.05|||Regression, Cox|Stratified by Type 2 Diabetes status at randomization.||Comparison Group: Placebo||1.05|0.74|0.1678
72499767|NCT03619213|144529726|SUPERIORITY||Hazard Ratio (HR)|0.94||||0.3425|TWO_SIDED|95.0|0.83|1.07|||Regression, Cox|Stratified by Type 2 Diabetes status at randomization.||Comparison Group: Placebo||1.07|0.83|0.3425
72620347|NCT00806026|144771857|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|2.4|STANDARD_ERROR_OF_MEAN|3.78||0.5299|TWO_SIDED|95.0|-5.1|9.9||This analysis was not included in the step-down procedure (if p\<0.05, then continue to next step) to control Type I error. The analysis was done at a significance level of alpha = 0.05, 2-sided.|Mixed Models Analysis|Spatial power covariance structure was used.||For pramipexole 0.25 mg versus placebo: Mixed model analysis was used to analyze RLS-NDI with baseline value, region (US or EU), treatment, week and treatment by week interaction as fixed effects.||9.9|-5.1|0.5299
72620348|NCT00806026|144771857|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-7.9|STANDARD_ERROR_OF_MEAN|3.69||0.0354|TWO_SIDED|95.0|-15.2|-0.5||This analysis was not included in the step-down procedure (if p\<0.05, then continue to next step) to control Type I error. The analysis was done at a significance level of alpha = 0.05, 2-sided.|Mixed Models Analysis|Spatial power covariance structure was used.||For pramipexole 0.5 mg versus placebo: Mixed model analysis was used to analyze RLS-NDI with baseline value, region (US or EU), treatment, week and treatment by week interaction as fixed effects.||-0.5|-15.2|0.0354
72620349|NCT00806026|144771859|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.0|STANDARD_ERROR_OF_MEAN|0.28||0.0004|TWO_SIDED|95.0|-1.55|-0.45||This analysis was step 9 in a step-down procedure (if p\<0.05, then continue to next step) used to control the Type I error rate. This procedure was stopped at Step 6. The analysis was done at a significance level of alpha = 0.05, 2-sided.|Mixed Models Analysis|Spatial power covariance structure was used.||For pregabalin 300 mg versus placebo: Mixed model analysis was used to analyze limb pain-VAS with baseline value, region (US or EU), treatment, week and treatment by week interaction as fixed effects.||-0.45|-1.55|0.0004
72620350|NCT00806026|144771859|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.43|STANDARD_ERROR_OF_MEAN|0.282||0.1242|TWO_SIDED|95.0|-0.99|0.12||This analysis was not included in the step-down procedure (if p\<0.05, then continue to next step) to control Type I error. The analysis was done at a significance level of alpha = 0.05, 2-sided.|Mixed Models Analysis|Spatial power covariance structure was used.||For pramipexole 0.25 mg versus placebo: Mixed model analysis was used to analyze limb pain-VAS with baseline value, region (US or EU), treatment, week and treatment by week interaction as fixed effects.||0.12|-0.99|0.1242
72620351|NCT00806026|144771859|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.55|STANDARD_ERROR_OF_MEAN|0.287||0.0553|TWO_SIDED|95.0|-1.12|0.01||This analysis was not included in the step-down procedure (if p\<0.05, then continue to next step) to control Type I error. The analysis was done at a significance level of alpha = 0.05, 2-sided.|Mixed Models Analysis|Spatial power covariance structure was used.||For pramipexole 0.5 mg versus placebo: Mixed model analysis was used to analyze limb pain-VAS with baseline value, region (US or EU), treatment, week and treatment by week interaction as fixed effects.||0.01|-1.12|0.0553
72620352|NCT00728182|144771877|SUPERIORITY_OR_OTHER|||||||0.445||95.0|||||ANCOVA|Data were cubic root transformed and modelled with multiple linear regression.||Comparison of the summed volume of new FLAIR lesions in the NA-1 and placebo treated groups.||||0.445
72620353|NCT00728182|144771878|SUPERIORITY_OR_OTHER||Adjusted Incidence Rate Ratio|0.53||||0.018|TWO_SIDED|95.0|0.38|0.74|||Generalized linear model|With log link and negative bnomial distribution.||Comparison of the total number of new ischemic lesions on DWI for NA-1 versus placebo treated groups.||0.74|0.38|0.018
72620354|NCT00728182|144771879|SUPERIORITY_OR_OTHER||Adjusted Incidence Rate Ratio|0.59||||0.048|TWO_SIDED|95.0|0.42|0.83|||Generalized linear model|With log link and negative binomial distribution.||Comparison of the total number of new FLAIR lesions in the NA-1 versus placebo treated groups.||0.83|0.42|0.048
72620355|NCT00728182|144771880|SUPERIORITY_OR_OTHER|||||||0.306||95.0|||||ANCOVA|Data were cubic root transformed and modelled with multiple linear regresion.||Comparison of the summed volume of new ischemic lesions on DWI.||||0.306
72499768|NCT00054847|144529744|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.07||||0.82|TWO_SIDED|95.0|0.62|1.84||Multiple logistic regression analysis was used to adjust for stratification factors and characteristics that were potentially predictive of graft patency. We also performed prespecified subgroup analyses and assessed treatment subgroup interaction.|Chi-squared|We performed as-treated and per-protocol analyses \& multiple imputations as sensitivity analyses to the intent-to-treat analysis on primary end point.||The study was designed to have 90% power to detect 1-year patency rates of 92% in radial artery vs 83% in saphenous vein grafts, with a 2-sided type I error of 5%and an expected 1-year catheterization completion rate of 65%.||1.84|.62|.82
72499769|NCT00054847|144529745|SUPERIORITY_OR_OTHER|||||||0.61|||||||Chi-squared|||||||.61
72620356|NCT00728182|144771881|SUPERIORITY_OR_OTHER||Relative Risk|1.0||||0.43|TWO_SIDED|95.0|0.9|1.1|||Chi-squared|||Number of patients obtaining a score on the NIHSS of 0-1 at Day 30.||1.1|0.9|0.43
72620357|NCT00728182|144771882|SUPERIORITY_OR_OTHER||Relative Risk|1.0||||1|TWO_SIDED|95.0|0.9|1.1|||Chi-squared|||Comparison of the number of patients with mRS scores of 0-2 at Day 30 for NA-1 and placebo treated groups.||1.1|0.9|1.00
72620358|NCT00728182|144771883|SUPERIORITY_OR_OTHER|||||||0.023||95.0|||||ANCOVA|||||||0.023
72620359|NCT00728182|144771884|SUPERIORITY_OR_OTHER||Adjusted Incidence Rate Ratio|0.36||||0.027|TWO_SIDED|95.0|0.17|0.73|||Adjusted Incidence Rate Ratio|||||0.73|0.17|0.027
72620360|NCT00728182|144771885|SUPERIORITY_OR_OTHER||Adjusted Incidence Rate Ratio|0.36||||0.046|TWO_SIDED|95.0|0.17|0.75|||Generalized linear model|||||0.75|0.17|0.046
72620361|NCT00728182|144771886|SUPERIORITY_OR_OTHER|||||||0.015|||||||ANCOVA|||||||0.015
72620362|NCT00728182|144771887|SUPERIORITY_OR_OTHER||Relative Risk|1.5||||0.02|TWO_SIDED|95.0|1.1|2.0|||Chi-squared|||||2.0|1.1|0.02
72620363|NCT00728182|144771888|SUPERIORITY_OR_OTHER||Relative Risk|1.3||||0.18|TWO_SIDED|95.0|0.95|1.7|||Chi-squared|||||1.7|0.95|0.18
72391813|NCT00256750|144290856|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|0.8||||0.3978|TWO_SIDED|95.0|-1.1|2.7|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Social Functioning, Month 12||2.7|-1.1|0.3978
72499770|NCT00054847|144529746|SUPERIORITY_OR_OTHER||||||>|0.99|||||||Chi-squared|||||||>.99
72499771|NCT03093155|144529748|SUPERIORITY||Hazard Ratio (HR)|0.31|||<|0.001|TWO_SIDED|90.0|0.2|0.49|||Regression, Cox|||||0.49|0.20|<0.001
72499772|NCT03093155|144529749|SUPERIORITY|||||||0.003|||||||Fisher Exact|||||||0.003
72454596|NCT02434328|144432677|OTHER|Treatment difference|Least Squares Mean Difference|-47.3|STANDARD_ERROR_OF_MEAN|9.69|||TWO_SIDED|95.0|-66.4|-28.3||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 72||-28.3|-66.4|
72391814|NCT00256750|144290856|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|1.5||||0.1263|TWO_SIDED|95.0|-0.4|3.5|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Social Functioning, Month 12||3.5|-0.4|0.1263
72391815|NCT00256750|144290856|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|2.3||||0.016|TWO_SIDED|95.0|0.4|4.2|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Vitality, Month 12||4.2|0.4|0.0160
72454597|NCT02434328|144432677|OTHER|Treatment difference|Least Squares Mean Difference|-28.0|STANDARD_ERROR_OF_MEAN|9.43|||TWO_SIDED|95.0|-46.5|-9.5||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 76||-9.5|-46.5|
72454598|NCT02434328|144432677|OTHER|Treatment difference|Least Squares Mean Difference|-40.9|STANDARD_ERROR_OF_MEAN|9.94|||TWO_SIDED|95.0|-60.4|-21.4||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 80||-21.4|-60.4|
72454599|NCT02434328|144432677|OTHER|Treatment difference|Least Squares Mean Difference|-31.0|STANDARD_ERROR_OF_MEAN|9.48|||TWO_SIDED|95.0|-49.6|-12.4||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 84||-12.4|-49.6|
72454600|NCT02434328|144432677|OTHER|Treatment difference|Least Squares Mean Difference|-42.6|STANDARD_ERROR_OF_MEAN|9.84|||TWO_SIDED|95.0|-61.9|-23.3||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 88||-23.3|-61.9|
72454601|NCT02434328|144432677|OTHER|Treatment difference|Least Squares Mean Difference|-29.1|STANDARD_ERROR_OF_MEAN|9.56|||TWO_SIDED|95.0|-47.9|-10.3||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 92||-10.3|-47.9|
72454602|NCT02434328|144432677|OTHER|Treatment difference|Least Squares Mean Difference|-42.6|STANDARD_ERROR_OF_MEAN|9.87|||TWO_SIDED|95.0|-62.0|-23.3||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 96||-23.3|-62.0|
72454603|NCT02434328|144432678|OTHER|Treatment difference|Least Squares Mean Difference|-36.1|STANDARD_ERROR_OF_MEAN|9.13|||TWO_SIDED|95.0|-54.0|-18.1||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|||-18.1|-54.0|
72454604|NCT02434328|144432679|OTHER|Treatment difference|Least Squares Mean Difference|-36.3|STANDARD_ERROR_OF_MEAN|9.56|||TWO_SIDED|95.0|-55.1|-17.6||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|||-17.6|-55.1|
72454605|NCT02434328|144432680|OTHER|Treatment difference|Least Squares Mean Difference|-30.8|STANDARD_ERROR_OF_MEAN|8.53|||TWO_SIDED|95.0|-47.6|-14.1||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 4 to Week 48||-14.1|-47.6|
72454606|NCT02434328|144432680|OTHER|Treatment difference|Least Squares Mean Difference|-33.5|STANDARD_ERROR_OF_MEAN|8.84|||TWO_SIDED|95.0|-50.8|-16.1||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 4 to Week 96||-16.1|-50.8|
72391816|NCT00256750|144290856|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|2.6||||0.0075|TWO_SIDED|95.0|0.7|4.5|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Vitality, Month 12||4.5|0.7|0.0075
72454607|NCT02434328|144432681|OTHER|Treatment difference|Least Squares Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|0.18|||TWO_SIDED|95.0|0.0|0.7||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline lesion size categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 12||0.7|0.0|
72454608|NCT02434328|144432681|OTHER|Treatment difference|Least Squares Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|0.17|||TWO_SIDED|95.0|-0.1|0.6||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline lesion size categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 48||0.6|-0.1|
72454609|NCT02434328|144432681|OTHER|Treatment difference|Least Squares Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|0.16|||TWO_SIDED|95.0|0.0|0.6||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline lesion size categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 96||0.6|0.0|
72454610|NCT02434328|144432682|OTHER|Treatment difference|Least Squares Mean Difference|-2.1|STANDARD_ERROR_OF_MEAN|4.8|||TWO_SIDED|95.0|-11.6|7.3||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-neurosensory retina categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 4||7.3|-11.6|
72391817|NCT00256750|144290856|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|0.4||||0.699|TWO_SIDED|95.0|-1.6|2.4|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Bodily Pain, Month 24||2.4|-1.6|0.6990
72391818|NCT00256750|144290856|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|1.5||||0.1608|TWO_SIDED|95.0|-0.6|3.5|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Bodily Pain, Month 24||3.5|-0.6|0.1608
72454611|NCT02434328|144432682|OTHER|Treatment difference|Least Squares Mean Difference|-3.8|STANDARD_ERROR_OF_MEAN|4.98|||TWO_SIDED|95.0|-13.6|6.0||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-neurosensory retina categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 8||6.0|-13.6|
72454612|NCT02434328|144432682|OTHER|Treatment difference|Least Squares Mean Difference|-4.5|STANDARD_ERROR_OF_MEAN|4.98|||TWO_SIDED|95.0|-14.3|5.3||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-neurosensory retina categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 12||5.3|-14.3|
72454613|NCT02434328|144432682|OTHER|Treatment difference|Least Squares Mean Difference|-3.7|STANDARD_ERROR_OF_MEAN|5.12|||TWO_SIDED|95.0|-13.7|6.4||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-neurosensory retina categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 16||6.4|-13.7|
72454614|NCT02434328|144432682|OTHER|Treatment difference|Least Squares Mean Difference|4.6|STANDARD_ERROR_OF_MEAN|5.11|||TWO_SIDED|95.0|-5.5|14.6||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-neurosensory retina categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 20||14.6|-5.5|
72454615|NCT02434328|144432682|OTHER|Treatment difference|Least Squares Mean Difference|-5.8|STANDARD_ERROR_OF_MEAN|5.35|||TWO_SIDED|95.0|-16.3|4.7||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-neurosensory retina categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 24||4.7|-16.3|
72454616|NCT02434328|144432682|OTHER|Treatment difference|Least Squares Mean Difference|-3.1|STANDARD_ERROR_OF_MEAN|5.13|||TWO_SIDED|95.0|-13.1|7.0||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-neurosensory retina categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 28||7.0|-13.1|
72454617|NCT02434328|144432682|OTHER|Treatment difference|Least Squares Mean Difference|-2.0|STANDARD_ERROR_OF_MEAN|5.37|||TWO_SIDED|95.0|-12.6|8.5||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-neurosensory retina categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 32||8.5|-12.6|
72454618|NCT02434328|144432682|OTHER|Treatment difference|Least Squares Mean Difference|-5.0|STANDARD_ERROR_OF_MEAN|5.15|||TWO_SIDED|95.0|-15.2|5.1||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-neurosensory retina categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 36||5.1|-15.2|
72499773|NCT03093155|144529750|SUPERIORITY||Hazard Ratio (HR)|0.56||||0.018|TWO_SIDED|90.0|0.38|0.84|||Regression, Cox|||||0.84|0.38|0.018
72499774|NCT03093155|144529751|SUPERIORITY|||||||0.77|||||||Fisher Exact|||||||0.77
72499775|NCT03093155|144529752|SUPERIORITY|||||||0.068|||||||Fisher Exact|||The RECIST responses were categorized as SD/PD or NA compared to PR or Better as a binary outcome.||||0.068
72499776|NCT00619229|144529754|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.94||||0.122|TWO_SIDED|95.0|-0.674|2.55||The criterion for significance (α) was set at one-sided α = 0.025, which means that only an effect in the expected direction was interpreted.|ANCOVA||For exploratory testing an Analysis of Variance-Covariance (ANCOVA) F-test with dependent variable 'difference in visual acuity', fixed factors 'treatment' and 'centre' and Baseline value as a covariate was used.|"The primary goal of the study was to test the following null hypothesis:~H0: μAlprostadil ≤ μPlacebo, against the alternative hypothesis H1: μAlprostadil \> μPlacebo, where μ denotes the mean differences in visual acuity between measurements at 3 months after the end of study drug infusion minus measurements at baseline as assessed as line difference on the standard ETDRS charts."||2.55|-0.674|0.1220
72499777|NCT01075178|144529777|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was assessed with a 95% 1-sided confidence interval for which the upper bound of the difference in the event rates (CASES minus CONTROLS) will correspond to an odds ratio less than 2 (that is, the odds ratio calculated at the upper confidence bound of the difference in event rates will be less than 2).|Observed odds ratio|0.81|||||ONE_SIDED|95.0||0.96|||exact binomial||"Result provided for 95% Confidence Interval (1-Sided) is the odds ratio calculated at the upper bound of the 1-sided 95% confidence interval for the difference in event rates (CASES minus CONTROLS)."|The null hypothesis was that the odds ratio was greater than or equal to 2. The planned sample size of 2000 participants (1000 participants in each group) provided greater than 90% power to determine non-inferiority based on the odds ratio less than 2.||0.96||
72499778|NCT01075178|144529778|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was assessed with a 95% 1-sided confidence interval for which the upper bound of the difference in the event rates (CASES minus CONTROLS) will correspond to an odds ratio less than 2 (that is, the odds ratio calculated at the upper confidence bound of the difference in event rates will be less than 2).|Observed odds ratio|0.8|||||ONE_SIDED|95.0||0.95|||exact binomial||"Result provided for 95% Confidence Interval (1-Sided) is the odds ratio calculated at the upper bound of the 1-sided 95% confidence interval for the difference in event rates (CASES minus CONTROLS)."|The null hypothesis was that the odds ratio was greater than or equal to 2. The planned sample size of 2000 participants (1000 participants in each group) provided greater than 90% power to determine non-inferiority based on the odds ratio less than 2.||0.95||
72454619|NCT02434328|144432682|OTHER|Treatment difference|Least Squares Mean Difference|-6.6|STANDARD_ERROR_OF_MEAN|5.3|||TWO_SIDED|95.0|-17.0|3.8||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-neurosensory retina categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 40||3.8|-17.0|
72562654|NCT03635983|144657167|SUPERIORITY||Estimate of Odds Ratio (OR)|0.7||||0.0626|TWO_SIDED|95.0|0.48|1.02|||Stratified Cochran-Mantel-Haenszel|two-sided|Strata adjusted odds ratio (NKTR-214 + Nivolumab over Nivolumab) using Mantel-Haenszel method.|Bempegaldesleukin+Nivolumab over Nivolumab||1.02|0.48|0.0626
72562655|NCT03635983|144657168|SUPERIORITY||Hazard Ratio (HR)|1.09||||0.3713||95.0|0.9|1.33||Log-rank stratified 2-sided. Boundary for statistical significance p-value \< 0.03|Log Rank||Stratified Cox proportional hazard model. Hazard Ratio is NKTR-214 + Nivolumab over Nivolumab|||1.33|0.90|0.3713
72454620|NCT02434328|144432682|OTHER|Treatment difference|Least Squares Mean Difference|-2.8|STANDARD_ERROR_OF_MEAN|5.42|||TWO_SIDED|95.0|-13.4|7.9||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-neurosensory retina categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 44||7.9|-13.4|
72454621|NCT02434328|144432682|OTHER|Treatment difference|Least Squares Mean Difference|-7.0|STANDARD_ERROR_OF_MEAN|5.4|||TWO_SIDED|95.0|-17.6|3.7||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-neurosensory retina categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 48||3.7|-17.6|
72454622|NCT02434328|144432682|OTHER|Treatment difference|Least Squares Mean Difference|-2.7|STANDARD_ERROR_OF_MEAN|5.19|||TWO_SIDED|95.0|-12.9|7.5||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-neurosensory retina categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 52||7.5|-12.9|
72454623|NCT02434328|144432682|OTHER|Treatment difference|Least Squares Mean Difference|-5.0|STANDARD_ERROR_OF_MEAN|5.31|||TWO_SIDED|95.0|-15.4|5.4||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-neurosensory retina categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 56||5.4|-15.4|
72454624|NCT02434328|144432682|OTHER|Treatment difference|Least Squares Mean Difference|-4.2|STANDARD_ERROR_OF_MEAN|5.15|||TWO_SIDED|95.0|-14.3|5.9||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-neurosensory retina categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 60||5.9|-14.3|
72454625|NCT02434328|144432682|OTHER|Treatment difference|Least Squares Mean Difference|-3.9|STANDARD_ERROR_OF_MEAN|5.24|||TWO_SIDED|95.0|-14.2|6.4||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-neurosensory retina categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 64||6.4|-14.2|
72454626|NCT02434328|144432682|OTHER|Treatment difference|Least Squares Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|5.17|||TWO_SIDED|95.0|-10.7|9.6||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-neurosensory retina categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 68||9.6|-10.7|
72454627|NCT02434328|144432682|OTHER|Treatment difference|Least Squares Mean Difference|-4.6|STANDARD_ERROR_OF_MEAN|5.24|||TWO_SIDED|95.0|-14.8|5.7||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-neurosensory retina categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 72||5.7|-14.8|
72499779|NCT01075178|144529779|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was assessed with a 95% 1-sided confidence interval for which the upper bound of the difference in the event rates (CASES minus CONTROLS) will correspond to an odds ratio less than 2 (that is, the odds ratio calculated at the upper confidence bound of the difference in event rates will be less than 2).|Observed odds ratio|1.05|||||ONE_SIDED|95.0||1.64|||exact binomial||"Result provided for 95% Confidence Interval (1-Sided) is the odds ratio calculated at the upper bound of the 1-sided 95% confidence interval for the difference in event rates (CASES minus CONTROLS)."|The null hypothesis was that the odds ratio was greater than or equal to 2. The planned sample size of 2000 participants (1000 participants in each group) provided greater than 90% power to determine non-inferiority based on the odds ratio less than 2.||1.64||
72499780|NCT01075178|144529780|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was assessed with a 95% 1-sided confidence interval for which the upper bound of the difference in the event rates (CASES minus CONTROLS) will correspond to an odds ratio less than 2 (that is, the odds ratio calculated at the upper confidence bound of the difference in event rates will be less than 2).|Observed odds ratio|0.9|||||ONE_SIDED|95.0||2.19|||exact binomial||"Result provided for 95% Confidence Interval (1-Sided) is the odds ratio calculated at the upper bound of the 1-sided 95% confidence interval for the difference in event rates (CASES minus CONTROLS)."|The null hypothesis was that the odds ratio was greater than or equal to 2. The planned sample size of 2000 participants (1000 participants in each group) provided greater than 90% power to determine non-inferiority based on the odds ratio less than 2.||2.19||
72499781|NCT01157117|144529844|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|12.0||||0.42|TWO_SIDED|95.0|-13.4|37.3||No adjustments were made to the p-value.|Fisher Exact|The a priori threshold for statistical significance is 0.05.||Number of participants who successfully consumed 10,000 mg of milk protein followed by an open feeding of milk was compared using Fisher's Exact test with the null hypothesis that there was no difference between treatment groups.||37.3|-13.4|0.42
72499782|NCT00826514|144529858|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.47|STANDARD_ERROR_OF_MEAN|0.392|||TWO_SIDED|95.0|-1.15|0.209||||||Analysis was based on analysis of co-variance (ANCOVA) model with baseline value, age and treatment as covariates.||0.209|-1.150|
72499783|NCT00826514|144529861|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-1.42|STANDARD_ERROR_OF_MEAN|1.901|||TWO_SIDED|90.0|-4.754|1.905||||||Change at Week 6, CPSI Total Score: Analysis was based on ANCOVA model with baseline value, age, baseline pain stratification group and treatment as covariates.||1.905|-4.754|
72454628|NCT02434328|144432682|OTHER|Treatment difference|Least Squares Mean Difference|-2.8|STANDARD_ERROR_OF_MEAN|5.23|||TWO_SIDED|95.0|-13.1|7.4||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-neurosensory retina categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 76||7.4|-13.1|
72454629|NCT02434328|144432682|OTHER|Treatment difference|Least Squares Mean Difference|-3.7|STANDARD_ERROR_OF_MEAN|5.33|||TWO_SIDED|95.0|-14.1|6.8||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-neurosensory retina categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 80||6.8|-14.1|
72454630|NCT02434328|144432682|OTHER|Treatment difference|Least Squares Mean Difference|-3.1|STANDARD_ERROR_OF_MEAN|5.3|||TWO_SIDED|95.0|-13.5|7.3||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-neurosensory retina categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 84||7.3|-13.5|
72454631|NCT02434328|144432682|OTHER|Treatment difference|Least Squares Mean Difference|-4.0|STANDARD_ERROR_OF_MEAN|5.39|||TWO_SIDED|95.0|-14.6|6.5||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-neurosensory retina categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 88||6.5|-14.6|
72454632|NCT02434328|144432682|OTHER|Treatment difference|Least Squares Mean Difference|-2.3|STANDARD_ERROR_OF_MEAN|5.25|||TWO_SIDED|95.0|-12.6|8.0|||ANOVA|Analyzed using ANOVA model with baseline CSFT-neurosensory retina categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 92||8.0|-12.6|
72454633|NCT02434328|144432682|OTHER|Treatment difference|Least Squares Mean Difference|-3.0|STANDARD_ERROR_OF_MEAN|5.42|||TWO_SIDED|95.0|-13.6|7.7||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-neurosensory retina categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 96||7.7|-13.6|
72454634|NCT02434328|144432683|OTHER||Difference in proportions|-6.6|||||TWO_SIDED|95.0|-13.2|-0.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 4||-0.3|-13.2|
72499784|NCT00826514|144529861|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-1.06|STANDARD_ERROR_OF_MEAN|0.931|||TWO_SIDED|90.0|-2.701|0.591||||||Change at Week 6, CPSI PD Score: Analysis was based on ANCOVA model with baseline value, age, baseline pain stratification group and treatment as covariates.||0.591|-2.701|
72499785|NCT00826514|144529861|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|0.38|STANDARD_ERROR_OF_MEAN|0.67|||TWO_SIDED|90.0|-0.789|1.541||||||Change at Week 6, CPSI US Score: Analysis was based on ANCOVA model with baseline value, age, baseline pain stratification group and treatment as covariates.||1.541|-0.789|
72499786|NCT00826514|144529861|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.58|STANDARD_ERROR_OF_MEAN|0.697|||TWO_SIDED|90.0|-1.785|0.631||||||Change at Week 6, CPSI QoL Score: Analysis was based on ANCOVA model with baseline value, age, baseline pain stratification group and treatment as covariates.||0.631|-1.785|
72499787|NCT00826514|144529862|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|0.18|STANDARD_ERROR_OF_MEAN|0.649|||TWO_SIDED|90.0|-0.99|1.348||||||Change at Week 6: Analysis was based on ANCOVA model with baseline value, age, baseline pain stratification group and treatment as covariates.||1.348|-0.990|
72499788|NCT00826514|144529863|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.19|STANDARD_ERROR_OF_MEAN|0.93|||TWO_SIDED|90.0|-1.829|1.452||||||Change at Week 6: Analysis was based on ANCOVA model with baseline value, age, baseline pain stratification group and treatment as covariates.||1.452|-1.829|
72499789|NCT00826514|144529864|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-33.56|STANDARD_ERROR_OF_MEAN|17.026|||TWO_SIDED|90.0|-64.144|-2.968||||||Change at Week 6: Analysis was based on ANCOVA model with baseline value, age, baseline pain stratification group and treatment as covariates.||-2.968|-64.144|
72499790|NCT00826514|144529865|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.47|STANDARD_ERROR_OF_MEAN|0.489|||TWO_SIDED|90.0|-1.364|0.415||||||Change at Week 6: Analysis was based on ANCOVA model with baseline value, age, baseline pain stratification group and treatment as covariates.||0.415|-1.364|
72562656|NCT03635983|144657172|SUPERIORITY||Odds Ratio (OR)|0.63||||||95.0|0.32|1.24|||||Logistic regression model with treatment, PD-L1 Status and treatment by PD-L1 Status interaction. Responders includes CR+PR|Bempegaldesleukin+Nivolumab vs. Nivolumab (PD-L1 Negative: \<1%)||1.24|0.32|
72454635|NCT02434328|144432683|OTHER||Difference in proportions|-8.5|||||TWO_SIDED|95.0|-13.8|-3.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 8||-3.0|-13.8|
72454636|NCT02434328|144432683|OTHER||Difference in proportions|-6.9|||||TWO_SIDED|95.0|-12.2|-1.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 12||-1.7|-12.2|
72499791|NCT00826514|144529866|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-1.37|STANDARD_ERROR_OF_MEAN|0.99|||TWO_SIDED|90.0|-3.146|0.401||||||Change at Week 6: Analysis was based on ANCOVA model with baseline value, age, baseline pain stratification group and treatment as covariates.||0.401|-3.146|
72499792|NCT00826514|144529867|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.04|STANDARD_ERROR_OF_MEAN|0.217|||TWO_SIDED|90.0|-0.417|0.334||||||Change at Week 6: Analysis was based on ANCOVA model with baseline value, age, baseline pain stratification group and treatment as covariates.||0.334|-0.417|
72499793|NCT00826514|144529868|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|0.02|STANDARD_ERROR_OF_MEAN|0.765|||TWO_SIDED|90.0|-1.791|1.822||||||Change at Week 6: Analysis was based on ANCOVA model with baseline value, age, baseline pain stratification group and treatment as covariates.||1.822|-1.791|
72499794|NCT00826514|144529869|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.833|||||TWO_SIDED|90.0|0.763|4.407||||||Week 6: Logistic regression model with age, baseline pain stratification group and treatment as covariates.||4.407|0.763|
72499795|NCT00826514|144529869|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.0|||||TWO_SIDED|90.0|0.388|2.575||||||Week 16: Logistic regression model with age, baseline pain stratification group and treatment as covariates.||2.575|0.388|
72562657|NCT03635983|144657172|SUPERIORITY||Odds Ratio (OR)|0.63||||0.9939|TWO_SIDED|95.0|0.39|1.02|||Stratified Cochran-Mantel-Haenszel|Interaction P-value|Logistic regression model with treatment, PD-L1 Status and treatment by PD-L1 Status interaction. Responders includes CR+PR|Bempegaldesleukin+Nivolumab vs. Nivolumab (PD-L1 Positive: \>=1%)||1.02|0.39|0.9939
72562658|NCT03635983|144657173|SUPERIORITY||Hazard Ratio (HR)|1.08|||||TWO_SIDED|95.0|0.81|1.43|||||Unstratified Hazard Ratio|Bempegaldesleukin+Nivolumab vs. Nivo (PD-L1 negative: \<1%)||1.43|0.81|
72620364|NCT01898091|144771890|SUPERIORITY_OR_OTHER|||||||0.84|||||||Wilcoxin rank sum test|||Simulations determined power to detect significant difference defined as a mean difference of 1 unit (MTS scale). Feasibility study provided proportion of patients in control and neem group with change scores of 0, 1, 2, 3, and 4 as (5%, 10%, 10%, 45% and 30%) and (15%, 20%, 30%, 25% and 10%), respectively. Simulated 10,000 trials using multinomial distributions by the percentages above, with 20 patients per group, provided 80% power to detect 0.9 unit difference using a one-sided alpha of 0.05.||||0.84
72620365|NCT01725308|144771931|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-2.4||||0.034|TWO_SIDED|95.0|-4.7|-0.2|||ANCOVA|||An analysis of covariance (ANCOVA) using a model where the total MADRS score at baseline is a covariate and the treatment group and bipolar disorder diagnosis (Type I/ II) are fixed effects.||-0.2|-4.7|0.034
72620366|NCT01725308|144771938|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-1.7||||0.033|TWO_SIDED|95.0|-3.3|-0.1|||ANCOVA|||At End of Treatment Period I/Week 8: An analysis of covariance (ANCOVA) using a model where the total HAM-D17 score at baseline is a covariate and the treatment group and bipolar disorder diagnosis (Type I/II) are fixed effects.||-0.1|-3.3|0.033
72454637|NCT02434328|144432683|OTHER||Difference in proportions|-14.2|||||TWO_SIDED|95.0|-20.8|-8.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 16||-8.3|-20.8|
72454638|NCT02434328|144432683|OTHER||Difference in proportions|3.1|||||TWO_SIDED|95.0|-2.9|9.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 20||9.6|-2.9|
72620367|NCT03511209|144771982|SUPERIORITY||Odds Ratio (OR)|2.13|STANDARD_ERROR_OF_MEAN|0.85||0.056|TWO_SIDED|95.0|0.98|4.64|||Regression, Logistic|||Compared CBTI plus Taper method A to CBTI plus Taper method B||4.64|0.98|0.056
72620368|NCT03511209|144771983|SUPERIORITY||Mean Difference (Net)|-1.06|STANDARD_ERROR_OF_MEAN|1.27||0.405|TWO_SIDED|95.0|-3.57|1.44|||Mixed Models Analysis|Interaction contrast of Treatment Group (CBTI plus Taper method A vs. CBTI plus Taper method B) by Time (6 Months vs. Baseline)||||1.44|-3.57|0.405
72454639|NCT02434328|144432683|OTHER||Difference in proportions|-19.2|||||TWO_SIDED|95.0|-25.5|-13.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 24||-13.0|-25.5|
72454640|NCT02434328|144432683|OTHER||Difference in proportions|-5.9|||||TWO_SIDED|95.0|-11.6|-0.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 28||-0.4|-11.6|
72562659|NCT03635983|144657173|SUPERIORITY||Hazard Ratio (HR)|1.12||||||95.0|0.83|1.51|||||Unstratified Hazard Ratio|Bempegaldesleukin+Nivolumab vs. Nivo (PD-L1 positive: \>=1%)||1.51|0.83|
72562660|NCT03635983|144657174|SUPERIORITY||Hazard Ratio (HR)|0.96|||||TWO_SIDED|95.0|0.66|1.4|||||Unstratified Hazard Ratio|Bempegaldesleukin+Nivolumab vs. Nivo (PD-L1 negative: \<1%)||1.40|0.66|
72562661|NCT03635983|144657174|SUPERIORITY||Hazard Ratio (HR)|0.88||||||95.0|0.58|1.33|||||Unstratified Hazard Ratio|Bempegaldesleukin+Nivolumab vs. Nivo (PD-L1 positive: \>=1%)||1.33|0.58|
72562662|NCT03712124|144657206|OTHER||Least Square (LS) Mean Difference|-6.44||||0.903|TWO_SIDED|95.0|-116.18|103.31|||ANCOVA|||Analysis was performed using an analysis of covariance (ANCOVA) model with change from baseline at Day 14 as the dependent variable and baseline maximum tolerated volume and treatment as covariates.||103.31|-116.18|0.9030
72562663|NCT03712124|144657207|OTHER||LS Mean Difference|98.45||||0.0042|TWO_SIDED|95.0|35.81|161.08|||ANCOVA|||Analysis was performed using ANCOVA model with change from baseline at Day 28 as the dependent variable and baseline maximum tolerated volume and treatment as covariates.||161.08|35.81|0.0042
72562664|NCT02412722|144657217|SUPERIORITY||Geometric Mean Ratio|0.59|||||TWO_SIDED|90.0|0.46|0.76||||||||0.76|0.46|
72620369|NCT04565756|144771999|OTHER|||||||||||||||||Since the primary objective of the study was to evaluate ocular safety and tolerability, no formal hypothesis testing was performed for any continuous or categorical variables. All statistical analyses were descriptive in nature and any statistical inferences were carried out according to the analysis plan and interpreted in view of the exploratory nature of the study.|Since the primary objective of the study was to evaluate ocular safety and tolerability, no formal hypothesis testing was performed for any continuous or categorical variables.|||
72454641|NCT02434328|144432683|OTHER||Difference in proportions|-9.8|||||TWO_SIDED|95.0|-16.5|-3.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 32||-3.5|-16.5|
72562665|NCT02412722|144657218|SUPERIORITY||Geometric Mean Ratio|0.9|||||TWO_SIDED|90.0|0.59|1.36||||||||1.36|0.59|
72562666|NCT02412722|144657219|SUPERIORITY||Geometric Mean Ratio|1.04|||||TWO_SIDED|90.0|0.72|1.49||||||||1.49|0.72|
72562667|NCT02412722|144657223|SUPERIORITY||Geometric Mean Ratio|1.07|||||TWO_SIDED|90.0|0.78|1.47||||||||1.47|0.78|
72562668|NCT02412722|144657224|SUPERIORITY||Geometric Mean Ratio|1.12|||||TWO_SIDED|90.0|0.75|1.68||||||||1.68|0.75|
72562669|NCT02412722|144657225|SUPERIORITY||Geometric Mean Ratio|0.92|||||TWO_SIDED|90.0|0.67|1.26||||||||1.26|0.67|
72562670|NCT01263561|144657257|NON_INFERIORITY_OR_EQUIVALENCE|A sample size calculation determined that 52 eyes were required to detect a 2.0 mmHg IOP difference with a power of 80%.||||||0.85|TWO_SIDED||||||t-test, 2 sided|||||||.85
72562671|NCT01263561|144657258|NON_INFERIORITY_OR_EQUIVALENCE|Power calculation only for main outcome measure of IOP.||||||0.24|TWO_SIDED||||||Kaplan Meier|||||||.24
72562672|NCT01263561|144657259|NON_INFERIORITY_OR_EQUIVALENCE|Power calculation only performed for main outcome measure of IOP.||||||0.8|TWO_SIDED|||||Above p is for number of subjects with any complication. P values above 0.05 are considered statistically insignificant in this study.|Chi-squared|||||||0.80
72620370|NCT03782103|144772033|NON_INFERIORITY|Investigational product upper bounds must be less than 0.5.|Median Difference (Final Values)|-0.2845|||||TWO_SIDED|95.0|-0.6033|0.0334||||||Groin 30 seconds post product application, Average Treatment Effect, calculated using a linear regression model for each body site, was used for primary analysis. In the model, the response was the post-treatment log10 CFU/cm\^2 bacterial counts and the predictors were the treatment effect as a fixed effect and the pre-treatment log10 CFU/cm\^2 bacterial counts as a covariate.||0.0334|-0.6033|
72620371|NCT03782103|144772033|SUPERIORITY|Investigational product lower bounds must be greater than 1.2.|Mean Difference (Final Values)|2.8535|||||TWO_SIDED|95.0|2.5415|3.1655||||||Groin 30 seconds post product application, Average Treatment Effect, calculated using a linear regression model for each body site, was used for primary analysis. In the model, the response was the post-treatment log10 CFU/cm\^2 bacterial counts and predictors were the treatment effect as a fixed effect and the pre-treatment log10 CFU/cm\^2 bacterial counts as a covariate.||3.1655|2.5415|
72620372|NCT03782103|144772034|NON_INFERIORITY|Investigational product average treatment effect upper bounds cannot be more than 0.5.|Mean Difference (Final Values)|0.0577|||||TWO_SIDED|95.0|-0.1457|0.2611||||||Abdomen 30 seconds post product application, Average Treatment Effect, calculated using a linear regression model for each body site, was used for primary analysis. In the model, the response was the post-treatment log10 CFU/cm\^2 bacterial counts and predictors were the treatment effect as a fixed effect and the pre-treatment log10 CFU/cm\^2 bacterial counts as a covariate.||0.2611|-0.1457|
72620373|NCT03782103|144772034|SUPERIORITY|Investigational product lower bounds must be greater than 1.2.|Mean Difference (Final Values)|1.8208|||||TWO_SIDED|95.0|1.6153|2.0264||||||Abdomen 30 seconds post product application, Average Treatment Effect, calculated using a linear regression model for each body site, was used for primary analysis. In the model, the response was the post-treatment log10 CFU/cm\^2 bacterial counts and predictors were the treatment effect as a fixed effect and the pre-treatment log10 CFU/cm\^2 bacterial counts as a covariate.||2.0264|1.6153|
72620374|NCT03378635|144772097|SUPERIORITY||||||<|0.001|||||||Log Rank|||The treatment group difference between dasiglucagon and placebo was evaluated inferentially using a pairwise two-sided log rank test. Kaplan-Meier estimate with 95% CI, p-value based on treatment group difference between dasiglucagon and placebo using a two-sided log-rank test stratified by injection site. Treatment groups without censoring utilized a distribution free method to compute the confidence interval for median time.||||<0.001
72620375|NCT03378635|144772098|SUPERIORITY||||||<|0.001||||||p-value was \<0.001 at all time points (10, 15, 20 and 30 minutes)|Fisher Exact|||Pairwise test of independent binomial proportions with Fisher's Exact test comparing dasiglucagon versus placebo. Testing followed an a priori defined hierarchical inferential test order, proceeding until the first failure to reject the null hypothesis comparing dasiglucagon versus placebo.||||<0.001
72620376|NCT03378635|144772099|SUPERIORITY||||||<|0.001||||||The p-value was \<0.001 at all time points (10, 15, 20 and 30 minutes)|ANCOVA|||Plasma glucose (PG) change from baseline at rescue was carried forward in patients who required rescue intravenous (IV) glucose before reaching PG recovery. Change from baseline was analyzed using an ANCOVA, with treatment group as fixed effect and baseline PG as covariate. Group difference was evaluated inferentially following an a priori defined hierarchical test order, proceeding until the first failure to reject the null hypothesis.||||<0.001
72620377|NCT03378635|144772100|SUPERIORITY||||||<|0.001|||||||Log Rank|||The treatment group difference between dasiglucagon and placebo was evaluated using a Kaplan-Meier estimate with 95% confidence interval, p-value based on a pairwise two-sided log-rank test versus placebo.||||<0.001
72620378|NCT03378635|144772101|SUPERIORITY||Mean Difference (Net)|0.131|||<|0.001|TWO_SIDED|95.0|0.1|0.171|||ANCOVA|||The log-transformed AUC endpoint was analyzed using an analysis of covariance model with treatment as fixed effect and baseline plasma glucose modeled as a covariate. The least squares means treatment group differences were back-transformed (anti-logged) for presentation as a ratio of the treatment group geometric means, with their corresponding 95% confidence interval.||0.171|0.1|<0.001
72620379|NCT03378635|144772102|SUPERIORITY||Mean Difference (Net)|0.91||||0.144|TWO_SIDED|95.0|0.801|1.033|||ANCOVA|||Least square mean ratio for GlucaGen: dasiglucagon||1.033|0.801|0.144
72454642|NCT02434328|144432683|OTHER||Difference in proportions|-8.0|||||TWO_SIDED|95.0|-13.6|-2.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 36||-2.5|-13.6|
72454643|NCT02434328|144432683|OTHER||Difference in proportions|-15.4|||||TWO_SIDED|95.0|-21.5|-9.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 40||-9.4|-21.5|
72620380|NCT03378635|144772103|SUPERIORITY||Mean Difference (Net)|0.844||||0.006|TWO_SIDED|95.0|0.749|0.951|||ANCOVA|||Least square mean ratio for GlucaGen: dasiglucagon||0.951|0.749|0.006
72620381|NCT02496156|144772112|SUPERIORITY||||||<|0.39||||||This is a computed p-value.|Mixed Models Analysis|||Missing data treatment was done using multiple imputation methods when data were determined to be Missing Completely at Random or Missing at Random. Assumptions underlying each statistical test were evaluated before proceeding with specific analyses.|For each outcome, a linear mixed effects model was fit; with the exception of the Knowledge test where a linear model was fit. Separate models were fit for Parents and adolescents except for HbA1C. The predictor variable is treatment group (SMDM vs. UCP). Covariates are gender, age, social economic status, and family structure as determined by (number of siblings and of caregivers in the home). A random intercept was fit for each subject across the longitudinal data. To accommodate missing values multiple imputation methodology was applied to the data, resulting in five imputed datasets. For each imputed dataset, a linear mixed effects model (or linear model for Knowledge Test) was fit; the resulting five models were pooled into a final model and summary statistics are presented. A two-sided Wald's t test determined significance of covariates. The significance level was 0.05. Appropriate model diagnostics were performed to assess model fit.|||<0.39
72454644|NCT02434328|144432683|OTHER||Difference in proportions|2.5|||||TWO_SIDED|95.0|-3.2|8.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 44||8.4|-3.2|
72454645|NCT02434328|144432683|OTHER||Difference in proportions|-15.9|||||TWO_SIDED|95.0|-22.4|-10.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 48||-10.4|-22.4|
72454646|NCT02434328|144432683|OTHER||Difference in proportions|-2.7|||||TWO_SIDED|95.0|-8.5|3.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 52||3.1|-8.5|
72454647|NCT02434328|144432683|OTHER||Difference in proportions|-9.0|||||TWO_SIDED|95.0|-15.7|-2.9|||Regression, Logistic|Hypothesis testing not pre-specified.|Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 56||-2.9|-15.7|
72454648|NCT02434328|144432683|OTHER||Difference in proportions|-3.9|||||TWO_SIDED|95.0|-9.8|2.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 60||2.2|-9.8|
72454649|NCT02434328|144432683|OTHER||Difference in proportions|-15.1|||||TWO_SIDED|95.0|-21.3|-8.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 64||-8.4|-21.3|
72454650|NCT02434328|144432683|OTHER||Difference in proportions|0.1|||||TWO_SIDED|95.0|-6.1|6.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 68||6.2|-6.1|
72454651|NCT02434328|144432683|OTHER||Difference in proportions|-16.6|||||TWO_SIDED|95.0|-22.6|-10.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 72||-10.5|-22.6|
72454652|NCT02434328|144432683|OTHER||Difference in proportions|-1.1|||||TWO_SIDED|95.0|-7.0|5.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 76||5.1|-7.0|
72454653|NCT02434328|144432683|OTHER||Difference in proportions|-11.0|||||TWO_SIDED|95.0|-17.4|-5.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 80||-5.0|-17.4|
72454654|NCT02434328|144432683|OTHER||Difference in proportions|-5.3|||||TWO_SIDED|95.0|-11.3|0.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 84||0.7|-11.3|
72562673|NCT01396421|144657261|SUPERIORITY_OR_OTHER||Treatment difference|-8.18|||<|0.0001|TWO_SIDED|95.0|-12.0|-4.4||Primary analysis was performed by fitting a Mixed Model Repeated Measures (MMRM) which included fixed class effect terms for treatment, trial site, visit week, and an interaction term of treatment by visit week.|Mixed Models Analysis|MMRM with fixed effect of treatment, clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.||Difference between average effect of brexpiprazole 2 and 4 mg/day and placebo was tested first at alpha level of 0.05. If statistically significant, then comparisons for each group (brexpiprazole 2 and 4 mg/day) versus placebo were performed.||-4.40|-12.0|<0.0001
72562674|NCT01396421|144657261|SUPERIORITY_OR_OTHER||Treatment difference|-7.64||||0.0006|TWO_SIDED|95.0|-12.0|-3.3|||Mixed Models Analysis|MMRM with fixed effect of treatment, clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.||Sample size was determined to achieve 90% power at alpha level of 0.025 (two-sided) to a detect treatment difference of -7.5 points in change from baseline in PANSS Total Score at Week 6 (last observation carried forward) between a brexpiprazole treatment of 4 mg/day (or 2 mg/day) and placebo using a two-sided z-test||-3.30|-12.0|0.0006
72562675|NCT01396421|144657261|SUPERIORITY_OR_OTHER||Traetment difference|-8.72|||<|0.0001|TWO_SIDED|95.0|-13.1|-4.37|||Mixed Models Analysis|MMRM with fixed effect of treatment, clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.||Sample size was determined to achieve 90% power at alpha level of 0.025 (two-sided) to a detect treatment difference of -7.5 points in change from baseline in PANSS Total Score at Week 6 (last observation carried forward) between a brexpiprazole treatment of 4 mg/day (or 2 mg/day) and placebo using a two-sided z-test||-4.37|-13.1|<0.0001
72391819|NCT00256750|144290856|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|2.2||||0.0214|TWO_SIDED|95.0|0.3|4.0|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|General Health, Month 24||4.0|0.3|0.0214
72454655|NCT02434328|144432683|OTHER||Difference in proportions|-12.0|||||TWO_SIDED|95.0|-18.9|-5.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 88||-5.9|-18.9|
72454656|NCT02434328|144432683|OTHER||Difference in proportions|-5.5|||||TWO_SIDED|95.0|-11.4|0.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 92||0.0|-11.4|
72622479|NCT00392288|144774960|SUPERIORITY_OR_OTHER|||||||0.2696||95.0||||Due to usage of a-priori ordered hypotheses, adjustment of p-values is not necessary. The pre-specified significance level was 0.05. The tests were carried out two-sided.|ANCOVA|ANCOVA model: Change in FEV1 = baseline FEV1 + age \[yrs\] + treatment + pooled center + previous corticosteroid therapy + holding chamber||This is an analysis of the change from baseline to week 12 or last visit. In this pairwise comparison Ciclesonide was compared with Placebo by testing the average effect of Ciclesonide 40 and Ciclesonide 80 versus Placebo. As statistical test a t-test was used to compare the corresponding least-square means of both treatment groups.||||0.2696
72454657|NCT02434328|144432683|OTHER||Difference in proportions|-14.5|||||TWO_SIDED|95.0|-20.3|-8.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 96||-8.3|-20.3|
72454658|NCT02434328|144432684|OTHER||Difference in proportions|1.5|||||TWO_SIDED|95.0|-2.5|5.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 4||5.4|-2.5|
72454659|NCT02434328|144432684|OTHER||Difference in proportions|-2.1|||||TWO_SIDED|95.0|-6.1|1.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 8||1.7|-6.1|
72454660|NCT02434328|144432684|OTHER||Difference in proportions|-1.4|||||TWO_SIDED|95.0|-5.3|2.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 12||2.2|-5.3|
72454661|NCT02434328|144432684|OTHER||Difference in proportions|0.1|||||TWO_SIDED|95.0|-4.5|4.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 16||4.4|-4.5|
72454662|NCT02434328|144432684|OTHER||Difference in proportions|8.2|||||TWO_SIDED|95.0|3.9|12.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 20||12.8|3.9|
72454663|NCT02434328|144432684|OTHER||Difference in proportions|-3.2|||||TWO_SIDED|95.0|-7.9|1.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 24||1.2|-7.9|
72454664|NCT02434328|144432684|OTHER||Difference in proportions|2.8|||||TWO_SIDED|95.0|-1.0|6.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 28||6.4|-1.0|
72454665|NCT02434328|144432684|OTHER||Difference in proportions|-0.5|||||TWO_SIDED|95.0|-5.5|4.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 32||4.0|-5.5|
72454666|NCT02434328|144432684|OTHER||Difference in proportions|-1.8|||||TWO_SIDED|95.0|-5.6|1.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 36||1.8|-5.6|
72454667|NCT02434328|144432684|OTHER||Difference in proportions|-1.3|||||TWO_SIDED|95.0|-6.0|3.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 40||3.1|-6.0|
72454668|NCT02434328|144432684|OTHER||Difference in proportions|3.8|||||TWO_SIDED|95.0|-0.5|8.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 44||8.0|-0.5|
72454669|NCT02434328|144432684|OTHER||Difference in proportions|-2.0|||||TWO_SIDED|95.0|-6.2|2.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 48||2.2|-6.2|
72454670|NCT02434328|144432684|OTHER||Difference in proportions|1.2|||||TWO_SIDED|95.0|-2.5|5.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 52||5.1|-2.5|
72454671|NCT02434328|144432684|OTHER||Difference in proportions|-1.2|||||TWO_SIDED|95.0|-5.9|3.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 56||3.1|-5.9|
72391820|NCT00256750|144290856|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|2.5||||0.00886|TWO_SIDED|95.0|0.6|4.4|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|General Health, Month 24||4.4|0.6|0.00886
72454672|NCT02434328|144432684|OTHER||Difference in proportions|-0.6|||||TWO_SIDED|95.0|-4.4|3.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 60||3.4|-4.4|
72454673|NCT02434328|144432684|OTHER||Difference in proportions|-1.8|||||TWO_SIDED|95.0|-6.2|2.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 64||2.1|-6.2|
72454674|NCT02434328|144432684|OTHER||Difference in proportions|2.6|||||TWO_SIDED|95.0|-1.2|6.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 68||6.5|-1.2|
72454675|NCT02434328|144432684|OTHER||Difference in proportions|0.2|||||TWO_SIDED|95.0|-4.2|4.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 72||4.3|-4.2|
72454676|NCT02434328|144432684|OTHER||Difference in proportions|0.4|||||TWO_SIDED|95.0|-3.5|4.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 76||4.2|-3.5|
72454677|NCT02434328|144432684|OTHER||Difference in proportions|-0.3|||||TWO_SIDED|95.0|-4.8|4.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 80||4.3|-4.8|
72454678|NCT02434328|144432684|OTHER||Difference in proportions|0.9|||||TWO_SIDED|95.0|-3.3|5.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 84||5.2|-3.3|
72454679|NCT02434328|144432684|OTHER||Difference in proportions|-0.1|||||TWO_SIDED|95.0|-4.5|3.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 88||3.9|-4.5|
72454680|NCT02434328|144432684|OTHER||Difference in proportions|3.8|||||TWO_SIDED|95.0|-0.1|8.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 92||8.0|-0.1|
72454681|NCT02434328|144432684|OTHER||Difference in proportions|0.2|||||TWO_SIDED|95.0|-4.3|4.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 96||4.6|-4.3|
72454682|NCT02434328|144432685|OTHER||Difference in proportions|-3.5|||||TWO_SIDED|95.0|-8.9|1.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 4||1.5|-8.9|
72454683|NCT02434328|144432685|OTHER||Difference in proportions|-2.6|||||TWO_SIDED|95.0|-7.6|2.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 8||2.5|-7.6|
72499796|NCT02207907|144529904|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-17.491|||<|0.0001|TWO_SIDED|95.0|-20.317|-14.664|||ANCOVA|From ANCOVA analysis with treatment group and smoking status as factors and baseline MGI and BI as covariates|Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|||-14.664|-20.317|<0.0001
72499797|NCT02207907|144529905|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.201|||<|0.0001|TWO_SIDED|95.0|-0.237|-0.165|||ANCOVA|From ANCOVA analysis with treatment group and smoking status as factors and baseline MGI and BI as covariates|Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|||-0.165|-0.237|<0.0001
72391821|NCT00256750|144290856|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|1.2||||0.2555|TWO_SIDED|95.0|-0.9|3.3|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Mental Health, Month 24||3.3|-0.9|0.2555
72454684|NCT02434328|144432685|OTHER||Difference in proportions|-1.6|||||TWO_SIDED|95.0|-6.9|3.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 12||3.7|-6.9|
72454685|NCT02434328|144432685|OTHER||Difference in proportions|-7.8|||||TWO_SIDED|95.0|-13.0|-2.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 16||-2.7|-13.0|
72454686|NCT02434328|144432685|OTHER||Difference in proportions|1.3|||||TWO_SIDED|95.0|-3.6|6.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 20||6.2|-3.6|
72499798|NCT02620020|144529910|SUPERIORITY||Least Squares (LS) Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.31||0.3876|TWO_SIDED|95.0|-0.88|0.34||Nominal p-value|Mixed Models Analysis|||||0.34|-0.88|0.3876
72391822|NCT00256750|144290856|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|0.8||||0.4804|TWO_SIDED|95.0|-1.4|2.9|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Mental Health, Month 24||2.9|-1.4|0.4804
72454687|NCT02434328|144432685|OTHER||Difference in proportions|-7.9|||||TWO_SIDED|95.0|-12.6|-3.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 24||-3.1|-12.6|
72454688|NCT02434328|144432685|OTHER||Difference in proportions|-2.1|||||TWO_SIDED|95.0|-6.8|2.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 28||2.7|-6.8|
72454689|NCT02434328|144432685|OTHER||Difference in proportions|-5.3|||||TWO_SIDED|95.0|-10.5|-0.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 32||-0.3|-10.5|
72454690|NCT02434328|144432685|OTHER||Difference in proportions|-5.5|||||TWO_SIDED|95.0|-10.3|-0.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 36||-0.4|-10.3|
72454691|NCT02434328|144432685|OTHER||Difference in proportions|-6.0|||||TWO_SIDED|95.0|-11.2|-0.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 40||-0.5|-11.2|
72454692|NCT02434328|144432685|OTHER||Difference in proportions|0.5|||||TWO_SIDED|95.0|-4.8|5.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 44||5.6|-4.8|
72454693|NCT02434328|144432685|OTHER||Difference in proportions|-9.1|||||TWO_SIDED|95.0|-13.8|-3.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 48||-3.9|-13.8|
72454694|NCT02434328|144432685|OTHER||Difference in proportions|-1.8|||||TWO_SIDED|95.0|-7.1|3.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 52||3.5|-7.1|
72499799|NCT02620020|144529910|SUPERIORITY||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.3||0.018|TWO_SIDED|95.0|-1.32|-0.12||Nominal p-value|Mixed Models Analysis|||||-0.12|-1.32|0.0180
72562676|NCT01396421|144657261|SUPERIORITY_OR_OTHER||Treatment difference|-2.89||||0.291|TWO_SIDED|95.0|-8.27|2.49|||Mixed Models Analysis|MMRM with fixed effect of treatment, clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.||Sample size was determined to achieve 90% power at alpha level of 0.025 (two-sided) to a detect treatment difference of -7.5 points in change from baseline in PANSS Total Score at Week 6 (last observation carried forward) between a brexpiprazole treatment of 4 mg/day (or 2 mg/day) and placebo using a two-sided z-test||2.49|-8.27|0.2910
72562677|NCT01396421|144657262|SUPERIORITY_OR_OTHER||Treatment difference|-0.36||||0.0006|TWO_SIDED|95.0|-0.56|-0.15|||Mixed Models Analysis|MMRM with fixed effect of treatment, clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.||Difference between the average effect of brexpiprazole 2 and 4 mg/day and placebo was tested first at alpha level of 0.05. If statistically significant, then comparisons for each group (brexpiprazole 2 and 4 mg/day) versus placebo were performed at a significance level of 0.05.||-0.15|-0.56|0.0006
72562678|NCT01396421|144657262|SUPERIORITY_OR_OTHER||Treatment difference|-0.38||||0.0012|TWO_SIDED|95.0|-0.61|-0.15|||Mixed Models Analysis|MMRM with fixed effect of treatment, clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.||||-0.15|-0.61|0.0012
72562679|NCT01396421|144657262|SUPERIORITY_OR_OTHER||Treatment difference|-0.33||||0.0056|TWO_SIDED|95.0|-0.56|-0.1|||Mixed Models Analysis|MMRM with fixed effect of treatment, clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.||||-0.10|-0.56|0.0056
72391823|NCT00256750|144290856|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|2.2||||0.0276|TWO_SIDED|95.0|0.2|4.2|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Physical Functioning, Month 24||4.2|0.2|0.0276
72454695|NCT02434328|144432685|OTHER||Difference in proportions|-5.2|||||TWO_SIDED|95.0|-11.1|0.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 56||0.1|-11.1|
72499800|NCT02620020|144529910|SUPERIORITY||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.3||0.0288|TWO_SIDED|95.0|-1.26|-0.07||Nominal p-value|Mixed Models Analysis|||||-0.07|-1.26|0.0288
72499801|NCT02620020|144529912|SUPERIORITY||LS mean difference|-2.2|STANDARD_ERROR_OF_MEAN|0.73||0.0028|TWO_SIDED|95.0|-3.65|-0.77||Nominal p-value|Mixed Models Analysis|||||-0.77|-3.65|0.0028
72499802|NCT02620020|144529912|SUPERIORITY||LS Mean Difference|-2.0|STANDARD_ERROR_OF_MEAN|0.72||0.0068|TWO_SIDED|95.0|-3.36|-0.54||Nominal p-value|Mixed Models Analysis|||||-0.54|-3.36|0.0068
72562680|NCT01396421|144657262|SUPERIORITY_OR_OTHER||Treatment difference|-0.03||||0.8491|TWO_SIDED|95.0|-0.31|0.26|||Mixed Models Analysis|MMRM with fixed effect of treatment, clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.||||0.26|-0.31|0.8491
72454696|NCT02434328|144432685|OTHER||Difference in proportions|-5.6|||||TWO_SIDED|95.0|-10.9|-0.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 60||-0.5|-10.9|
72454697|NCT02434328|144432685|OTHER||Difference in proportions|-5.1|||||TWO_SIDED|95.0|-10.9|0.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 64||0.6|-10.9|
72454698|NCT02434328|144432685|OTHER||Difference in proportions|-5.2|||||TWO_SIDED|95.0|-11.0|-0.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 68||-0.1|-11.0|
72454699|NCT02434328|144432685|OTHER||Difference in proportions|-6.9|||||TWO_SIDED|95.0|-12.5|-1.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 72||-1.2|-12.5|
72454700|NCT02434328|144432685|OTHER||Difference in proportions|-5.5|||||TWO_SIDED|95.0|-10.7|-0.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 76||-0.3|-10.7|
72454701|NCT02434328|144432685|OTHER||Difference in proportions|-6.5|||||TWO_SIDED|95.0|-12.4|-0.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 80||-0.9|-12.4|
72454702|NCT02434328|144432685|OTHER||Difference in proportions|-1.4|||||TWO_SIDED|95.0|-7.0|4.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 84||4.4|-7.0|
72454703|NCT02434328|144432685|OTHER||Difference in proportions|-4.8|||||TWO_SIDED|95.0|-10.5|1.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 88||1.3|-10.5|
72499803|NCT02620020|144529912|SUPERIORITY||LS Mean Difference|-2.5|STANDARD_ERROR_OF_MEAN|0.72||0.0006|TWO_SIDED|95.0|-3.88|-1.06||Nominal p-value|Mixed Models Analysis|||||-1.06|-3.88|0.0006
72499804|NCT02620020|144529913|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.14||0.1501|TWO_SIDED|95.0|-0.46|0.07||Nominal p-value|Mixed Models Analysis|||||0.07|-0.46|0.1501
72454704|NCT02434328|144432685|OTHER||Difference in proportions|-5.6|||||TWO_SIDED|95.0|-11.4|0.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 92||0.5|-11.4|
72454705|NCT02434328|144432685|OTHER||Difference in proportions|-5.9|||||TWO_SIDED|95.0|-11.5|-0.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 96||-0.3|-11.5|
72454706|NCT02434328|144432686|OTHER||Difference in proportions|-6.9|||||TWO_SIDED|95.0|-14.2|0.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 4||0.2|-14.2|
72454707|NCT02434328|144432686|OTHER||Difference in proportions|-9.2|||||TWO_SIDED|95.0|-15.5|-2.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 8||-2.5|-15.5|
72454708|NCT02434328|144432686|OTHER||Difference in proportions|-8.7|||||TWO_SIDED|95.0|-15.0|-2.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 12||-2.6|-15.0|
72454709|NCT02434328|144432686|OTHER||Difference in proportions|-15.7|||||TWO_SIDED|95.0|-22.9|-9.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 16||-9.0|-22.9|
72454710|NCT02434328|144432686|OTHER||Difference in proportions|7.7|||||TWO_SIDED|95.0|0.9|14.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 20||14.8|0.9|
72499805|NCT02620020|144529913|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.13||0.2603|TWO_SIDED|95.0|-0.41|0.11||Nominal p-value|Mixed Models Analysis|||||0.11|-0.41|0.2603
72499806|NCT02620020|144529913|SUPERIORITY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.13||0.0135|TWO_SIDED|95.0|-0.59|-0.07||Nominal p-value|Mixed Models Analysis|||||-0.07|-0.59|0.0135
72562681|NCT01396421|144657263|SUPERIORITY_OR_OTHER||Treatment difference|-1.5||||0.0644|TWO_SIDED|95.0|-3.09|0.09||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, and baseline visit interaction as covariates.|Mixed Models Analysis|Week 1||||0.09|-3.09|0.0644
72454711|NCT02434328|144432686|OTHER||Difference in proportions|-20.0|||||TWO_SIDED|95.0|-27.3|-13.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 24||-13.1|-27.3|
72454712|NCT02434328|144432686|OTHER||Difference in proportions|-3.9|||||TWO_SIDED|95.0|-10.4|2.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 28||2.4|-10.4|
72620382|NCT02496156|144772113|SUPERIORITY||||||>|0.05||||||Computed p-value exceeded the .05 level of significance.|Mixed Models Analysis||||For each outcome, a linear mixed effects model was fit; with the exception of the Knowledge test where a linear model was fit. Separate models were fit for Parents and adolescents except for HbA1C. The predictor variable is treatment group (SMDM vs. UCP). Covariates are gender, age, social economic status, and family structure as determined by (number of siblings and of caregivers in the home). A random intercept was fit for each subject across the longitudinal data. To accommodate missing values multiple imputation methodology was applied to the data, resulting in five imputed datasets. For each imputed dataset, a linear mixed effects model (or linear model for Knowledge Test) was fit; the resulting five models were pooled into a final model and summary statistics are presented. A two-sided Wald's t test determined significance of covariates. The significance level was 0.05. Appropriate model diagnostics were performed to assess model fit.|||>0.05
72620383|NCT02496156|144772114|SUPERIORITY||||||>|0.05||||||This is a computed p-value.|Mixed Models Analysis|||See description of analysis below.|For each outcome, a linear mixed effects model was fit; with the exception of the Knowledge test where a linear model was fit. Separate models were fit for Parents and adolescents except for HbA1C. The predictor variable is treatment group (SMDM vs. UCP). Covariates are gender, age, social economic status, and family structure as determined by (number of siblings and of caregivers in the home). A random intercept was fit for each subject across the longitudinal data. To accommodate missing values multiple imputation methodology was applied to the data, resulting in five imputed datasets. For each imputed dataset, a linear mixed effects model (or linear model for Knowledge Test) was fit; the resulting five models were pooled into a final model and summary statistics are presented. A two-sided Wald's t test determined significance of covariates. The significance level was 0.05. Appropriate model diagnostics were performed to assess model fit.|||>0.05
72620384|NCT02496156|144772115|SUPERIORITY||||||>|0.05||||||Computed p-value|ANCOVA|Difference in post-test scores with baseline Knowledge test score as the covariate.||||||>0.05
72620385|NCT02496156|144772117|SUPERIORITY|See analysis description below.|||||>|0.05||||||Computed p-value|ANOVA||||For each outcome, a linear mixed effects model was fit; with the exception of the Knowledge test where a linear model was fit. Separate models were fit for Parents and adolescents except for HbA1C. The predictor variable is treatment group (SMDM vs. UCP). Covariates are gender, age, social economic status, and family structure as determined by (number of siblings and of caregivers in the home). A random intercept was fit for each subject across the longitudinal data. To accommodate missing values multiple imputation methodology was applied to the data, resulting in five imputed datasets. For each imputed dataset, a linear mixed effects model (or linear model for Knowledge Test) was fit; the resulting five models were pooled into a final model and summary statistics are presented. A two-sided Wald's t test determined significance of covariates. The significance level was 0.05. Appropriate model diagnostics were performed to assess model fit.|||>0.05
72454713|NCT02434328|144432686|OTHER||Difference in proportions|-9.7|||||TWO_SIDED|95.0|-16.7|-2.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 32||-2.5|-16.7|
72454714|NCT02434328|144432686|OTHER||Difference in proportions|-9.4|||||TWO_SIDED|95.0|-15.8|-3.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 36||-3.4|-15.8|
72499807|NCT01276288|144529943|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing in a confirmatory sense|Geometric mean ratio|107.08|STANDARD_DEVIATION|11.8||0.0092|TWO_SIDED|90.0|97.11|118.07||"p-value for ratio outside interval 80-125%~Ratio calculated as Empa plus HCT divided by Empa"|ANOVA|Model was adjusted for sequence, period and treatment as fixed effects while subjects within sequences as random effect|Standard deviation is actually the geometric coefficient of variation (gCV) reflecting intra-subject variabilities|Only patients in sequences Empa/Empa+HCT were included||118.07|97.11|0.0092
72620386|NCT00507507|144772158|SUPERIORITY_OR_OTHER|||||||0.016||||||A Fisher exact test with a 0.05 two-sided significance level was used.|Fisher Exact|||The null hypothesis was that there was no difference in the proportion of subjects with HBV DNA \< 400 copies/mL at Week 192 between the Tenofovir DF and FTC+Tenofovir DF groups; the alternative hypothesis was that there was a difference. The sample size provided at least 85% power to detect a difference of 30% between the groups, assuming response rates of 30% and 60% in the Tenofovir DF and FTC+Tenofovir DF groups, respectively.||||0.016
72454715|NCT02434328|144432686|OTHER||Difference in proportions|-16.5|||||TWO_SIDED|95.0|-23.4|-9.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 40||-9.6|-23.4|
72454716|NCT02434328|144432686|OTHER||Difference in proportions|3.4|||||TWO_SIDED|95.0|-3.3|10.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 44||10.4|-3.3|
72454717|NCT02434328|144432686|OTHER||Difference in proportions|-18.1|||||TWO_SIDED|95.0|-24.9|-11.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 48||-11.8|-24.9|
72620387|NCT00507507|144772159|SUPERIORITY_OR_OTHER|||||||0.05||||||A Fisher exact test with a 0.05 two-sided significance level was used.|Fisher Exact|||Analysis at Week 48: the null hypothesis was that there was no difference in the proportion of subjects with HBV DNA \< 400 copies/mL at Week 48 between the Tenofovir DF and FTC+Tenofovir DF groups; the alternative hypothesis was that there was a difference.||||0.050
72454718|NCT02434328|144432686|OTHER||Difference in proportions|-3.0|||||TWO_SIDED|95.0|-9.2|3.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 52||3.2|-9.2|
72454719|NCT02434328|144432686|OTHER||Difference in proportions|-9.4|||||TWO_SIDED|95.0|-16.3|-2.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 56||-2.8|-16.3|
72454720|NCT02434328|144432686|OTHER||Difference in proportions|-5.7|||||TWO_SIDED|95.0|-12.5|1.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 60||1.1|-12.5|
72454721|NCT02434328|144432686|OTHER||Difference in proportions|-15.5|||||TWO_SIDED|95.0|-21.9|-8.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 64||-8.5|-21.9|
72454722|NCT02434328|144432686|OTHER||Difference in proportions|0.9|||||TWO_SIDED|95.0|-5.9|7.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 68||7.5|-5.9|
72454723|NCT02434328|144432686|OTHER||Difference in proportions|-14.9|||||TWO_SIDED|95.0|-21.4|-8.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 72||-8.1|-21.4|
72454724|NCT02434328|144432686|OTHER||Difference in proportions|-0.8|||||TWO_SIDED|95.0|-7.5|5.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 76||5.4|-7.5|
72454725|NCT02434328|144432686|OTHER||Difference in proportions|-10.4|||||TWO_SIDED|95.0|-17.2|-3.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 80||-3.4|-17.2|
72391824|NCT00256750|144290856|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|1.5||||0.1285|TWO_SIDED|95.0|-0.4|3.5|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Physical Functioning, Month 24||3.5|-0.4|0.1285
72454726|NCT02434328|144432686|OTHER||Difference in proportions|-4.5|||||TWO_SIDED|95.0|-11.4|2.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 84||2.3|-11.4|
72454727|NCT02434328|144432686|OTHER||Difference in proportions|-11.0|||||TWO_SIDED|95.0|-18.2|-4.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 88||-4.1|-18.2|
72454728|NCT02434328|144432686|OTHER||Difference in proportions|-2.9|||||TWO_SIDED|95.0|-9.4|3.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 92||3.5|-9.4|
72454729|NCT02434328|144432686|OTHER||Difference in proportions|-14.1|||||TWO_SIDED|95.0|-21.3|-7.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 96||-7.2|-21.3|
72454730|NCT00378898|144432722|SUPERIORITY|||||||0.047|||||||t-test, 2 sided|||||||.047
72454731|NCT03137459|144432732|SUPERIORITY||Risk Difference (RD)|0.059|||||TWO_SIDED|95.0|0.014|0.105|||||Analysis performed using GEE to account for clustering of participants within practices.|||.105|.014|
72454732|NCT03137459|144432732|SUPERIORITY||Odds Ratio (OR)|1.83|||||TWO_SIDED|95.0|1.14|2.93|||||Determined using mixed effects models, accounting for clustering of participants in practices and adjusting for unbalanced covariates: education, employment, stage of change for each ACP behavior|||2.93|1.14|
72454733|NCT03137459|144432733|SUPERIORITY||Risk Difference (RD)|0.082|||||TWO_SIDED|95.0|0.014|0.15|||||Adjusted for clustering|||.150|.014|
72454734|NCT03137459|144432733|SUPERIORITY||Odds Ratio (OR)|1.39|||||TWO_SIDED|95.0|0.96|2.0|||||Accounting for clustering and adjusted for covariates as described in primary outcome|||2.0|.96|
72454735|NCT03137459|144432734|SUPERIORITY||Risk Difference (RD)|0.133|||||TWO_SIDED|95.0|0.066|0.201|||||Accounting for clustering|||.201|.066|
72454736|NCT03137459|144432734|SUPERIORITY||Odds Ratio (OR)|1.73|||||TWO_SIDED|95.0|1.22|2.47|||||Accounting for clustering and adjusted for covariates as presenting for primary outcome|||2.47|1.22|
72454737|NCT03137459|144432735|SUPERIORITY||Risk Difference (RD)|0.07|||||TWO_SIDED|95.0|-0.05|0.188||||||||.188|-.05|
72454738|NCT03137459|144432735|SUPERIORITY||Odds Ratio (OR)|1.15|||||TWO_SIDED|95.0|0.72|1.85|||||Accounting for clustering and adjusting for covariates as described for primary outcome|||1.85|.72|
72454739|NCT04921358|144432758|OTHER||Hazard Ratio (HR)|1.02|||||TWO_SIDED|95.0|0.75|1.39|||||Hazard ratio and 95% confidence intervals (CIs) were estimated using a Cox regression model stratified by histological subtype (nonsquamous vs squamous), race (Asian vs Non-Asian) and PD-L1 expression (\<1% Tumor Cells (TC) vs \>=1% TC).|||1.39|0.75|
72454740|NCT04921358|144432759|OTHER||Hazard Ratio (HR)|0.82|||||TWO_SIDED|95.0|0.62|1.07|||||Hazard ratio and 95% CIs were estimated using a Cox regression model stratified by histological subtype (nonsquamous vs squamous), race (Asian vs Non-Asian) and PD-L1 expression (\<1% TC vs \>=1% TC).|||1.07|0.62|
72454741|NCT04921358|144432760|OTHER||Hazard Ratio (HR)|0.64|||||TWO_SIDED|95.0|0.5|0.83|||||Hazard ratio and 95% CIs were estimated using a Cox regression model stratified by histological subtype (nonsquamous vs squamous), race (Asian vs Non-Asian) and PD-L1 expression (\<1% TC vs \>=1% TC).|||0.83|0.50|
72454742|NCT05646719|144432769|SUPERIORITY||Odds Ratio (OR)|2.27|||<|0.01|TWO_SIDED|95.0|1.23|4.2|||t-test, 2 sided|||||4.20|1.23|<0.01
72454743|NCT05646719|144432769|SUPERIORITY||Odds Ratio (OR)|1.44|||||TWO_SIDED|95.0||||||||||||
72454744|NCT03559205|144432786|SUPERIORITY||Mean Difference (Final Values)|-0.02||||0.96|TWO_SIDED|95.0|-0.74|0.7|||t-test, 2 sided|||2 Week Analysis||0.70|-0.74|0.96
72454745|NCT03559205|144432787|SUPERIORITY||Mean Difference (Final Values)|-0.13||||0.9|TWO_SIDED|95.0|-2.31|2.04|||t-test, 2 sided|||Baseline||2.04|-2.31|0.90
72562682|NCT01396421|144657263|SUPERIORITY_OR_OTHER||Treatment difference|-1.99||||0.0139|TWO_SIDED|95.0|-3.58|-0.41||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|Week 1||||-0.41|-3.58|0.0139
72454746|NCT03559205|144432787|SUPERIORITY||Mean Difference (Final Values)|2.01||||0.21|TWO_SIDED|95.0|-1.17|5.19|||t-test, 2 sided|||2 Week Analysis||5.19|-1.17|0.21
72454747|NCT03559205|144432787|SUPERIORITY||Mean Difference (Final Values)|0.94||||0.63|TWO_SIDED|95.0|-2.95|4.83|||t-test, 2 sided|||3-Month||4.83|-2.95|0.63
72454748|NCT03559205|144432788|SUPERIORITY||Mean Difference (Final Values)|2.63||||0.15|TWO_SIDED|95.0|-1.0|6.26|||t-test, 2 sided|||Baseline||6.26|-1.00|0.15
72454749|NCT03559205|144432788|SUPERIORITY||Mean Difference (Final Values)|0.22||||0.3|TWO_SIDED|95.0|-2.02|6.45|||t-test, 2 sided|||Week 2 analysis||6.45|-2.02|0.30
72454750|NCT03559205|144432788|SUPERIORITY||Mean Difference (Final Values)|0.5||||0.85|TWO_SIDED|95.0|-4.89|5.9|||t-test, 2 sided|||3-Month||5.90|-4.89|0.85
72454751|NCT03559205|144432789|SUPERIORITY||Mean Difference (Final Values)|0.11||||0.72|TWO_SIDED|95.0|-0.51|0.74|||t-test, 2 sided|||Care and respect||0.74|-0.51|0.72
72454752|NCT03559205|144432789|SUPERIORITY||Mean Difference (Final Values)|0.23||||0.46|TWO_SIDED|95.0|-0.38|0.83|||t-test, 2 sided|||Understanding \& engagement||0.83|-0.38|0.46
72454753|NCT03559205|144432790|SUPERIORITY||Mean Difference (Final Values)|0.15||||0.3|TWO_SIDED|95.0|-0.13|0.42|||t-test, 2 sided|||2-weeks||0.42|-0.13|0.30
72454754|NCT03559205|144432790|SUPERIORITY||Mean Difference (Final Values)|0.16||||0.38|TWO_SIDED|95.0|-0.2|0.52|||t-test, 2 sided|||3-months||0.52|-0.20|0.38
72454755|NCT03559205|144432791|SUPERIORITY||Mean Difference (Final Values)|-0.3||||0.61|TWO_SIDED|95.0|-1.48|0.88|||t-test, 2 sided|||||0.88|-1.48|0.61
72454756|NCT04237792|144432831|OTHER||Odds Ratio (OR)|0.1|||<|0.001|TWO_SIDED|95.0|0.03|0.29|||Cochran-Mantel-Haenszel|||||0.29|0.03|<0.001
72454757|NCT04237792|144432832|OTHER||Odds Ratio (OR)|0.18||||0.022|TWO_SIDED|95.0|0.04|0.82|||Mantel Haenszel|||||0.82|0.04|0.022
72454758|NCT04237792|144432832|OTHER||Odds Ratio (OR)|0.05|||<|0.001|TWO_SIDED|95.0|0.01|0.26|||Mantel Haenszel|||||0.26|0.01|<0.001
72454759|NCT04237792|144432833|OTHER||Odds Ratio (OR)|0.11||||0.006|TWO_SIDED|95.0|0.02|0.59|||Mantel Haenszel|||||0.59|0.02|0.006
72454760|NCT04237792|144432833|OTHER||Odds Ratio (OR)|1.68||||0.597|TWO_SIDED|95.0|0.25|11.27|||Mantel Haenszel|||||11.27|0.25|0.597
72454761|NCT04237792|144432833|OTHER||Odds Ratio (OR)|0.54||||0.374|TWO_SIDED|95.0|0.14|2.07|||Mantel Haenszel|||||2.07|0.14|0.374
72454762|NCT04237792|144432833|OTHER||Odds Ratio (OR)|0.1||||0.001|TWO_SIDED|95.0|0.02|0.44|||Mantel Haenszel|||||0.44|0.02|0.001
72454763|NCT04237792|144432833|OTHER||Odds Ratio (OR)|0.32||||0.015|TWO_SIDED|95.0|0.13|0.81|||Mantel Haenszel|||||0.81|0.13|0.015
72454764|NCT04237792|144432833|OTHER||Odds Ratio (OR)|0.3||||0.024|TWO_SIDED|95.0|0.1|0.87|||Mantel Haenszel|||||0.87|0.10|0.024
72454765|NCT04237792|144432834|OTHER|||||||0.021|||||||Wilcoxon (Mann-Whitney)|||||||0.021
72454766|NCT04237792|144432834|OTHER|||||||0.007|||||||Wilcoxon (Mann-Whitney)|||||||0.007
72454767|NCT04237792|144432834|OTHER|||||||0.225|||||||Wilcoxon (Mann-Whitney)|||||||0.225
72454768|NCT04237792|144432834|OTHER|||||||0.213|||||||Wilcoxon (Mann-Whitney)|||||||0.213
72454769|NCT04237792|144432834|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
72454770|NCT04237792|144432834|OTHER|||||||0.006|||||||Wilcoxon (Mann-Whitney)|||||||0.006
72454771|NCT04237792|144432834|OTHER|||||||0.011|||||||Wilcoxon (Mann-Whitney)|||||||0.011
72454772|NCT04237792|144432834|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
72454773|NCT04237792|144432834|OTHER|||||||0.004|||||||Wilcoxon (Mann-Whitney)|||||||0.004
72454774|NCT04237792|144432835|OTHER|||||||0.016|||||||Log Rank|||||||0.016
72454775|NCT04237792|144432835|OTHER|||||||0.005|||||||Log Rank|||||||0.005
72454776|NCT04237792|144432835|OTHER|||||||0.368|||||||Log Rank|||||||0.368
72454777|NCT04237792|144432835|OTHER|||||||0.358|||||||Log Rank|||||||0.358
72454778|NCT04237792|144432835|OTHER|||||||0|||||||Log Rank|||||||0.000
72454779|NCT04237792|144432835|OTHER|||||||0.001|||||||Log Rank|||||||0.001
72454780|NCT04237792|144432835|OTHER|||||||0.02|||||||Log Rank|||||||0.020
72454781|NCT04237792|144432835|OTHER|||||||0|||||||Log Rank|||||||0.000
72562683|NCT01396421|144657263|SUPERIORITY_OR_OTHER||Treatment difference|0.35||||0.7231|TWO_SIDED|95.0|-1.61|2.32||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|Week 1||||2.32|-1.61|0.7231
72562684|NCT01396421|144657263|SUPERIORITY_OR_OTHER||Treatment difference|-5.14||||0.0018|TWO_SIDED|95.0|-8.36|-1.93||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|Week 3||||-1.93|-8.36|0.0018
72620388|NCT00507507|144772159|SUPERIORITY_OR_OTHER|||||||0.009||||||A Fisher exact test with a 0.05 two-sided significance level was used.|Fisher Exact|||Analysis at Week 96: the null hypothesis was that there was no difference in the proportion of subjects with HBV DNA \< 400 copies/mL at Week 96 between the Tenofovir DF and FTC+Tenofovir DF groups; the alternative hypothesis was that there was a difference.||||0.009
72620389|NCT00507507|144772159|SUPERIORITY_OR_OTHER|||||||0.03||||||A Fisher exact test with a 0.05 two-sided significance level was used.|Fisher Exact|||Analysis at Week 144: the null hypothesis was that there was no difference in the proportion of subjects with HBV DNA \< 400 copies/mL at Week 144 between the Tenofovir DF and FTC+Tenofovir DF groups; the alternative hypothesis was that there was a difference.||||0.030
72391825|NCT00256750|144290856|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|1.7||||0.1352|TWO_SIDED|95.0|-0.5|3.9|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Role Emotional, Month 24||3.9|-0.5|0.1352
72391826|NCT00256750|144290856|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|1.3||||0.2663|TWO_SIDED|95.0|-1.0|3.5|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Role Emotional, Month 24||3.5|-1.0|0.2663
72499808|NCT01276288|144529943|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing in a confirmatory sense|Geometric mean ratio|107.83|STANDARD_DEVIATION|8.9||0.003|TWO_SIDED|90.0|100.14|116.11||"p-value for ratio outside interval 80-125%~Ratio calculated as Empa plus TOR divided by Empa"|ANOVA|Model was adjusted for sequence, period and treatment as fixed effects while subjects within sequences as random effect|Standard deviation is actually the geometric coefficient of variation (gCV) reflecting intra-subject variabilities|Only patients in sequences Empa/Empa+TOR were included||116.11|100.14|0.0030
72499809|NCT01276288|144529944|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing in a confirmatory sense|Geometric mean ratio|102.78|STANDARD_DEVIATION|18.3||0.0199|TWO_SIDED|90.0|88.55|119.29||"p-value for ratio outside interval 80-125%~Ratio calculated as Empa+ HCT divided by Empa"|ANOVA|Model was adjusted for sequence, period and treatment as fixed effects while subjects within sequences as random effect|Standard deviation is actually the geometric coefficient of variation (gCV) reflecting intra-subject variabilities|Only patients in sequences Empa/Empa+HCT were included||119.29|88.55|0.0199
72499810|NCT01276288|144529944|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing in a confirmatory sense|Geometric mean ratio|107.5|STANDARD_DEVIATION|11.3||0.0086|TWO_SIDED|90.0|97.9|118.04||"p-value for ratio outside interval 80-125%~Ratio calculated as Empa+ TOR divided by Empa"|ANOVA|Model was adjusted for sequence, period and treatment as fixed effects while subjects within sequences as random effect|Standard deviation is actually the geometric coefficient of variation (gCV) reflecting intra-subject variabilities|Only patients in sequences Empa/Empa+TOR were included||118.04|97.90|0.0086
72499811|NCT01276288|144529945|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing in a confirmatory sense|Geometric mean ratio|96.27|STANDARD_DEVIATION|9.6||0.0008|TWO_SIDED|90.0|89.08|104.05||"p-value for ratio outside interval 80-125%~Ratio calculated as Empa plus HCT divided by HCT"|ANOVA|Model was adjusted for treatment as fixed effect and subject as random effect|Standard deviation is actually the geometric coefficient of variation (gCV) reflecting intra-subject variabilities|Only patients in sequences Empa/Empa+HCT were included||104.05|89.08|0.0008
72499812|NCT01276288|144529946|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing in a confirmatory sense|Geometric mean ratio|101.77|STANDARD_DEVIATION|17.1||0.0114|TWO_SIDED|90.0|88.63|116.85||"p-value for ratio outside interval 80-125%~Ratio calculated as Empa+ HCT divided by HCT"|ANOVA|Model was adjusted for treatment as fixed effect and subject as random effect|Standard deviation is actually the geometric coefficient of variation (gCV) reflecting intra-subject variabilities|Only patients in sequences Empa/Empa+HCT were included||116.85|88.63|0.0114
72499813|NCT01276288|144529947|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing in a confirmatory sense|Geometric mean ratio|101.44|STANDARD_DEVIATION|2.9|<|0.0001|TWO_SIDED|90.0|99.06|103.88||"p-value for ratio outside interval 80-125%~Ratio calculated as Empa plus TOR divided by TOR"|ANOVA|Model was adjusted for treatment as fixed effect and subject as random effect|Standard deviation is actually the geometric coefficient of variation (gCV) reflecting intra-subject variabilities|Only patients in sequences Empa/Empa+TOR were included||103.88|99.06|<0.0001
72499814|NCT01276288|144529947|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing in a confirmatory sense|Geometric mean ratio|104.42|STANDARD_DEVIATION|4.8|<|0.0001|TWO_SIDED|90.0|100.39|108.62||"p-value for ratio outside interval 80-125%~Ratio calculated as Empa+ TOR-M1 divided by TOR-M1"|ANOVA|Model was adjusted for treatment as fixed effect and subject as random effect|Standard deviation is actually the geometric coefficient of variation (gCV) reflecting intra-subject variabilities|Only patients in sequences Empa/Empa+TOR were included||108.62|100.39|<0.0001
72562685|NCT01396421|144657263|SUPERIORITY_OR_OTHER||Treatment difference|-3.75||||0.0045|TWO_SIDED|95.0|-6.33|-1.17||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates|Mixed Models Analysis|Week 2||||-1.17|-6.33|0.0045
72562686|NCT01396421|144657263|SUPERIORITY_OR_OTHER||Treatment difference|1.84||||0.2568|TWO_SIDED|95.0|-1.34|5.02||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|Week 2||||5.02|-1.34|0.2568
72391827|NCT00256750|144290856|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|2.5||||0.0164|TWO_SIDED|95.0|0.5|4.5|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Role-Physical, Month 24||4.5|0.5|0.0164
72391828|NCT00256750|144290856|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|3.9||||0.0002|TWO_SIDED|95.0|1.9|5.9|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Role-Physical, Month 24||5.9|1.9|0.0002
72391829|NCT00256750|144290856|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|1.3||||0.1914|TWO_SIDED|95.0|-0.7|3.3|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Social Functioning, Month 24||3.3|-0.7|0.1914
72391830|NCT00256750|144290856|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|0.4||||0.6882|TWO_SIDED|95.0|-1.6|2.4|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Social Functioning, Month 24||2.4|-1.6|0.6882
72562687|NCT01396421|144657263|SUPERIORITY_OR_OTHER||Treatment difference|-4.4||||0.0009|TWO_SIDED|95.0|-6.97|-1.82||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|Week 2||||-1.82|-6.97|0.0009
72391831|NCT00256750|144290856|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|2.0||||0.0547|TWO_SIDED|95.0|0.0|4.0|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Vitality, Month 24||4.0|-0.0|0.0547
72620390|NCT00507507|144772160|SUPERIORITY_OR_OTHER|||||||0.703||||||A Fisher exact test with a 0.05 two-sided significance level was used.|Fisher Exact|||Analysis at Week 48: the null hypothesis was that there was no difference in the proportion of subjects with HBV DNA \< 169 copies/mL at Week 48 between the Tenofovir DF and FTC+Tenofovir DF groups; the alternative hypothesis was that there was a difference.||||0.703
72454782|NCT04237792|144432835|OTHER|||||||0.005|||||||Log Rank|||||||0.005
72454783|NCT04237792|144432836|OTHER|||||||0.884|||||||Log Rank|||||||0.884
72454784|NCT04237792|144432836|OTHER|||||||0.662|||||||Log Rank|||||||0.662
72454785|NCT04237792|144432836|OTHER|||||||0.236|||||||Log Rank|||||||0.236
72454786|NCT04237792|144432836|OTHER|||||||0.733|||||||Log Rank|||||||0.733
72454787|NCT04237792|144432836|OTHER|||||||0.128|||||||Log Rank|||||||0.128
72454788|NCT04237792|144432836|OTHER|||||||0.165|||||||Log Rank|||||||0.165
72454789|NCT04237792|144432836|OTHER|||||||0.752|||||||Log Rank|||||||0.752
72454790|NCT04237792|144432836|OTHER|||||||0.139|||||||Log Rank|||||||0.139
72454791|NCT04237792|144432836|OTHER|||||||0.051|||||||Log Rank|||||||0.051
72454792|NCT04237792|144432838|OTHER|||||||0.124|||||||ANOVA|||||||0.124
72454793|NCT04237792|144432838|OTHER|||||||0.186|||||||ANOVA|||||||0.186
72454794|NCT04237792|144432838|OTHER|||||||0.47|||||||ANOVA|||||||0.470
72454795|NCT04237792|144432838|OTHER|||||||0.845|||||||ANOVA|||||||0.845
72454796|NCT04237792|144432838|OTHER|||||||0.621|||||||ANOVA|||||||0.621
72454797|NCT04237792|144432838|OTHER|||||||0.747|||||||ANOVA|||||||0.747
72454798|NCT04237792|144432838|OTHER|||||||0.218|||||||ANOVA|||||||0.218
72620391|NCT00507507|144772160|SUPERIORITY_OR_OTHER|||||||0.034||||||A Fisher exact test with a 0.05 two-sided significance level was used.|Fisher Exact|||Analysis at Week 96: the null hypothesis was that there was no difference in the proportion of subjects with HBV DNA \< 169 copies/mL at Week 96 between the Tenofovir DF and FTC+Tenofovir DF groups; the alternative hypothesis was that there was a difference.||||0.034
72454799|NCT04237792|144432838|OTHER|||||||0.181|||||||ANOVA|||||||0.181
72454800|NCT04237792|144432838|OTHER|||||||0.984|||||||ANOVA|||||||0.984
72454801|NCT04237792|144432839|OTHER|||||||0.048|||||||ANOVA|||||||0.048
72454802|NCT04237792|144432839|OTHER|||||||0.106|||||||ANOVA|||||||0.106
72454803|NCT04237792|144432839|OTHER|||||||0.196|||||||ANOVA|||||||0.196
72454804|NCT04237792|144432839|OTHER|||||||0.94|||||||ANOVA|||||||0.940
72454805|NCT04237792|144432839|OTHER|||||||0.824|||||||ANOVA|||||||0.824
72454806|NCT04237792|144432839|OTHER|||||||0.678|||||||ANOVA|||||||0.678
72454807|NCT04237792|144432839|OTHER|||||||0.129|||||||ANOVA|||||||0.129
72454808|NCT04237792|144432839|OTHER|||||||0.16|||||||ANOVA|||||||0.160
72454809|NCT04237792|144432839|OTHER|||||||0.872|||||||ANOVA|||||||0.872
72454810|NCT03739866|144432868|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
72454811|NCT03739866|144432868|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
72454812|NCT03739866|144432868|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
72454813|NCT03739866|144432868|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
72454814|NCT03739866|144432868|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
72454815|NCT01335867|144432882|SUPERIORITY|||||||0.14|||||||Chi-squared|||||||.14
72454816|NCT01335867|144432884|SUPERIORITY|||||||0.24|||||||t-test, 2 sided|||||||.24
72454817|NCT01335867|144432885|SUPERIORITY|||||||0.2|||||||Chi-squared|||||||.20
72454818|NCT01335867|144432886|SUPERIORITY|||||||0.64|||||||t-test, 2 sided|||||||.64
72454819|NCT03057600|144432887|SUPERIORITY|||||||0.2252|||||||exact one-sample binomial tests|||||||0.2252
72454820|NCT03057600|144432887|SUPERIORITY|||||||0.9437|||||||exact one-sample binomial tests|||||||0.9437
72454821|NCT03057600|144432887|SUPERIORITY|||||||0.5797|||||||exact one-sample binomial tests|||||||0.5797
72454822|NCT03057600|144432887|SUPERIORITY|||||||0.0243|||||||exact one-sample binomial tests|||||||0.0243
72454823|NCT01968967|144432896|SUPERIORITY_OR_OTHER||LS Mean Difference|-56.2|STANDARD_ERROR_OF_MEAN|1.1|<|0.001|TWO_SIDED|95.0|-58.3|-54.0|||MMRM|||Least square (LS) mean difference and associated 95 percent (%) confidence interval (CI), and p-value were derived from mixed effect model repeat measurement (MMRM) model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-54.0|-58.3|<0.001
72454824|NCT01968967|144432897|SUPERIORITY_OR_OTHER||LS Mean Difference|-35.0|STANDARD_ERROR_OF_MEAN|0.76|<|0.001|TWO_SIDED|95.0|-36.5|-33.5|||MMRM|||Week 12: LS mean difference and associated 95% CI and p-value were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-33.5|-36.5|<0.001
72454825|NCT01968967|144432897|SUPERIORITY_OR_OTHER||LS Mean Difference|-31.6|STANDARD_ERROR_OF_MEAN|0.89|||TWO_SIDED|95.0|-33.3|-29.8||||||Week 24: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-29.8|-33.3|
72454826|NCT01968967|144432897|SUPERIORITY_OR_OTHER||LS Mean Difference|-24.7|STANDARD_ERROR_OF_MEAN|0.96|||TWO_SIDED|95.0|-26.6|-22.8||||||Week 52: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-22.8|-26.6|
72454827|NCT01968967|144432898|SUPERIORITY_OR_OTHER||LS Mean Difference|-50.8|STANDARD_ERROR_OF_MEAN|1.04|<|0.001|TWO_SIDED|95.0|-52.9|-48.8|||MMRM|||Week 12: LS mean difference and associated 95% CI and p-value were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-48.8|-52.9|<0.001
72454828|NCT01968967|144432898|SUPERIORITY_OR_OTHER||LS Mean Difference|-46.1|STANDARD_ERROR_OF_MEAN|1.19|||TWO_SIDED|95.0|-48.5|-43.8||||||Week 24: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-43.8|-48.5|
72620392|NCT00507507|144772160|SUPERIORITY_OR_OTHER|||||||0.011||||||A Fisher exact test with a 0.05 two-sided significance level was used.|Fisher Exact|||Analysis at Week 144: the null hypothesis was that there was no difference in the proportion of subjects with HBV DNA \< 169 copies/mL at Week 144 between the Tenofovir DF and FTC+Tenofovir DF groups; the alternative hypothesis was that there was a difference.||||0.011
72620393|NCT00507507|144772160|SUPERIORITY_OR_OTHER|||||||0.007||||||A Fisher exact test with a 0.05 two-sided significance level was used.|Fisher Exact|||Analysis at Week 192: the null hypothesis was that there was no difference in the proportion of subjects with HBV DNA \< 169 copies/mL at Week 192 between the Tenofovir DF and FTC+Tenofovir DF groups; the alternative hypothesis was that there was a difference.||||0.007
72620394|NCT00507507|144772161|SUPERIORITY_OR_OTHER|||||||0.01||||||A Wilcoxon rank-sum (2-sided) test was used, with no adjustments for covariates.|Wilcoxon (Mann-Whitney)|||The null hypothesis was that there was no difference of change in HBV DNA from baseline between the Tenofovir DF and FTC+Tenofovir DF groups; the alternative hypothesis was that there was a difference.||||0.010
72620395|NCT00507507|144772162|SUPERIORITY_OR_OTHER|||||||0.019||||||A Wilcoxon rank-sum (2-sided) test was used, with no adjustments for covariates.|Wilcoxon (Mann-Whitney)|||The null hypothesis was that there was no difference of change in HBV DNA from baseline between the Tenofovir DF and FTC+Tenofovir DF groups; the alternative hypothesis was that there was a difference.||||0.019
72620396|NCT00507507|144772163|SUPERIORITY_OR_OTHER|||||||0.186||||||A Wilcoxon rank-sum (2-sided) test was used, with no adjustments for covariates.|Wilcoxon (Mann-Whitney)|||The null hypothesis was that there was no difference of change in HBV DNA from baseline between the Tenofovir DF and FTC+Tenofovir DF groups; the alternative hypothesis was that there was a difference.||||0.186
72620397|NCT00507507|144772164|SUPERIORITY_OR_OTHER|||||||0.07||||||A Wilcoxon rank-sum (2-sided) test was used, with no adjustments for covariates.|Wilcoxon (Mann-Whitney)|||The null hypothesis was that there was no difference of change in HBV DNA from baseline between the Tenofovir DF and FTC+Tenofovir DF groups; the alternative hypothesis was that there was a difference.||||0.070
72620398|NCT00507507|144772165|SUPERIORITY_OR_OTHER|||||||0.467||||||A Fisher exact test with a 0.05 two-sided significance level was used, with no adjustments for covariates.|Fisher Exact|||Analysis at Week 48: the null hypothesis was that there was no difference in the proportion of subjects with normal ALT at Week 48 between the Tenofovir DF and FTC+Tenofovir DF groups; the alternative hypothesis was that there was a difference.||||0.467
72620399|NCT00507507|144772165|SUPERIORITY_OR_OTHER|||||||1||||||A Fisher exact test with a 0.05 two-sided significance level was used, with no adjustments for covariates.|Fisher Exact|||Analysis at Week 96: the null hypothesis was that there was no difference in the proportion of subjects with normal ALT at Week 96 between the Tenofovir DF and FTC+Tenofovir DF groups; the alternative hypothesis was that there was a difference.||||1.000
72620400|NCT00507507|144772165|SUPERIORITY_OR_OTHER|||||||0.529||||||A Fisher exact test with a 0.05 two-sided significance level was used, with no adjustments for covariates.|Fisher Exact|||Analysis at Week 144: the null hypothesis was that there was no difference in the proportion of subjects with normal ALT at Week 144 between the Tenofovir DF and FTC+Tenofovir DF groups; the alternative hypothesis was that there was a difference.||||0.529
72620401|NCT00507507|144772165|SUPERIORITY_OR_OTHER|||||||0.451||||||A Fisher exact test with a 0.05 two-sided significance level was used, with no adjustments for covariates.|Fisher Exact|||Analysis at Week 192: the null hypothesis was that there was no difference in the proportion of subjects with normal ALT at Week 192 between the Tenofovir DF and FTC+Tenofovir DF groups; the alternative hypothesis was that there was a difference.||||0.451
72454829|NCT01968967|144432898|SUPERIORITY_OR_OTHER||LS Mean Difference|-36.1|STANDARD_ERROR_OF_MEAN|1.28|||TWO_SIDED|95.0|-38.6|-33.6||||||Week 52: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-33.6|-38.6|
72454830|NCT01968967|144432899|SUPERIORITY_OR_OTHER||LS Mean Difference|-50.1|STANDARD_ERROR_OF_MEAN|1.04|<|0.001|TWO_SIDED|95.0|-52.1|-48.0|||MMRM|||Week 12: LS mean difference and associated 95% CI and p-value were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-48.0|-52.1|<0.001
72454831|NCT01968967|144432899|SUPERIORITY_OR_OTHER||LS Mean Difference|-45.5|STANDARD_ERROR_OF_MEAN|1.22|||TWO_SIDED|95.0|-47.9|-43.1||||||Week 24: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-43.1|-47.9|
72454832|NCT01968967|144432899|SUPERIORITY_OR_OTHER||LS Mean Difference|-35.9|STANDARD_ERROR_OF_MEAN|1.33|||TWO_SIDED|95.0|-38.5|-33.3||||||Week 52: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-33.3|-38.5|
72620402|NCT00507507|144772166|SUPERIORITY_OR_OTHER|||||||0.496||||||A Fisher exact test with a 0.05 two-sided significance level was used.|Fisher Exact|||Analysis at Week 96: the null hypothesis was that there was no difference in the proportion of subjects with HBeAg loss between the Tenofovir DF and FTC+Tenofovir DF groups; the alternative hypothesis was that there was a difference.||||0.496
72620403|NCT00507507|144772166|SUPERIORITY_OR_OTHER|||||||0.119||||||A Fisher exact test with a 0.05 two-sided significance level was used.|Fisher Exact|||Analysis at Week 144: the null hypothesis was that there was no difference in the proportion of subjects with HBeAg loss between the Tenofovir DF and FTC+Tenofovir DF groups; the alternative hypothesis was that there was a difference.||||0.119
72620404|NCT00507507|144772166|SUPERIORITY_OR_OTHER|||||||0.365||||||A Fisher exact test with a 0.05 two-sided significance level was used.|Fisher Exact|||Analysis at Week 192: the null hypothesis was that there was no difference in the proportion of subjects with HBeAg loss between the Tenofovir DF and FTC+Tenofovir DF groups; the alternative hypothesis was that there was a difference.||||0.365
72620405|NCT00507507|144772167|SUPERIORITY_OR_OTHER|||||||0.496||||||A Fisher exact test with a 0.05 two-sided significance level was used.|Fisher Exact|||Analysis at Week 96: the null hypothesis was that there was no difference in the proportion of subjects with seroconversion to anti-HBe between the Tenofovir DF and FTC+Tenofovir DF groups; the alternative hypothesis was that there was a difference.||||0.496
72454833|NCT01968967|144432900|SUPERIORITY_OR_OTHER||LS Mean Difference|-57.7|STANDARD_ERROR_OF_MEAN|1.29|<|0.001|TWO_SIDED|95.0|-60.2|-55.2|||MMRM|||Week 12: LS mean difference and associated 95% CI and p-value were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region. An unstructured variance covariance matrix was used.||-55.2|-60.2|<0.001
72454834|NCT01968967|144432900|SUPERIORITY_OR_OTHER||LS Mean Difference|-53.1|STANDARD_ERROR_OF_MEAN|1.55|||TWO_SIDED|95.0|-56.1|-50.0||||||Week 24: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region. An unstructured variance covariance matrix was used.||-50.0|-56.1|
72454835|NCT01968967|144432900|SUPERIORITY_OR_OTHER||LS Mean Difference|-42.8|STANDARD_ERROR_OF_MEAN|1.7|||TWO_SIDED|95.0|-46.2|-39.5||||||Week 52: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region. An unstructured variance covariance matrix was used.||-39.5|-46.2|
72499815|NCT01276288|144529947|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing in a confirmatory sense|Geometric mean ratio|103.19|STANDARD_DEVIATION|8.9||0.0005|TWO_SIDED|90.0|95.93|111.01||"p-value for ratio outside interval 80-125%~Ratio calculated as Empa+ TOR-M3 divided by TOR-M3"|ANOVA|Model was adjusted for treatment as fixed effect and subject as random effect|Standard deviation is actually the geometric coefficient of variation (gCV) reflecting intra-subject variabilities|Only patients in sequences Empa/Empa+TOR were included||111.01|95.93|0.0005
72499816|NCT01276288|144529948|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing in a confirmatory sense|Geometric mean ratio|104.43|STANDARD_DEVIATION|13.1||0.0066|TWO_SIDED|90.0|93.81|116.25||"p-value for ratio outside interval 80-125%~Ratio calculated as Empa+ TOR divided by TOR"|ANOVA|Model was adjusted for treatment as fixed effect and subject as random effect|Standard deviation is actually the geometric coefficient of variation (gCV) reflecting intra-subject variabilities|Only patients in sequences Empa/Empa+TOR were included||116.25|93.81|0.0066
72499817|NCT01276288|144529948|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing in a confirmatory sense|Geometric mean ratio|102.67|STANDARD_DEVIATION|10.6||0.0012|TWO_SIDED|90.0|94.13|111.97||"p-value for ratio outside interval 80-125%~Ratio calculated as Empa+ TOR-M1 divided by TOR-M1"|ANOVA|Model was adjusted for treatment as fixed effect and subject as random effect|Standard deviation is actually the geometric coefficient of variation (gCV) reflecting intra-subject variabilities|Only patients in sequences Empa/Empa+TOR were included||111.97|94.13|0.0012
72499818|NCT01276288|144529948|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing in a confirmatory sense|Geometric mean ratio|102.42|STANDARD_DEVIATION|5.8|<|0.0001|TWO_SIDED|90.0|97.65|107.42||"p-value for ratio outside interval 80-125%~Ratio calculated as Empa+ TOR-M3 divided by TOR-M3"|ANOVA|Model was adjusted for treatment as fixed effect and subject as random effect|Standard deviation is actually the geometric coefficient of variation (gCV) reflecting intra-subject variabilities|Only patients in sequences Empa/Empa+TOR were included||107.42|97.65|<0.0001
72499819|NCT03168867|144529951|SUPERIORITY||||||<|0.05|TWO_SIDED|95.0|||||Mixed Models Analysis|||||||<.05
72499820|NCT01147809|144530014|SUPERIORITY_OR_OTHER||Percent difference|21.1||||0.103|TWO_SIDED|95.0|-3.9|52.5|||ANCOVA|||||52.5|-3.9|0.103
72562688|NCT01396421|144657263|SUPERIORITY_OR_OTHER||Treatment difference|-3.45||||0.036|TWO_SIDED|95.0|-6.67|-0.23||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|Week 3||||-0.23|-6.67|0.0360
72562689|NCT01396421|144657263|SUPERIORITY_OR_OTHER||Treatment difference|0.04||||0.9876|TWO_SIDED|95.0|-4.53|4.6||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|Week 4||||4.60|-4.53|0.9876
72562690|NCT01396421|144657263|SUPERIORITY_OR_OTHER||Treatment difference|-7.61|||<|0.0001|TWO_SIDED|95.0|-11.3|-3.93||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|Week 4||||-3.93|-11.3|<0.0001
72562691|NCT01396421|144657263|SUPERIORITY_OR_OTHER||Treatment difference|-5.16||||0.0062|TWO_SIDED|95.0|-8.85|-1.47||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates|Mixed Models Analysis|Week 4||||-1.47|-8.85|0.0062
72562692|NCT01396421|144657263|SUPERIORITY_OR_OTHER||Treatment difference|1.93||||0.3407|TWO_SIDED|95.0|-2.05|5.9||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|Week 3||||5.90|-2.05|0.3407
72562693|NCT01396421|144657263|SUPERIORITY_OR_OTHER||Treatment difference|-7.86||||0.0001|TWO_SIDED|95.0|-11.9|-3.86||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates|Mixed Models Analysis|Week 5||||-3.86|-11.9|0.0001
72562694|NCT01396421|144657263|SUPERIORITY_OR_OTHER||Treatment difference|-7.15||||0.0005|TWO_SIDED|95.0|-11.2|-3.14||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|Week 5||||-3.14|-11.2|0.0005
72562695|NCT01396421|144657263|SUPERIORITY_OR_OTHER||Treatment difference|-1.12||||0.657|TWO_SIDED|95.0|-6.07|3.83||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|Week 5|Because only the comparison of brexpiprazole 4 mg/day versus placebo met the threshold in the primary analysis, the following analysis is not part for the formal statistical testing and is descriptive only.|||3.83|-6.07|0.6570
72562696|NCT01396421|144657264|SUPERIORITY_OR_OTHER||Treatment difference|-0.02||||0.6553|TWO_SIDED|95.0|-0.13|0.08||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|Week 1||||0.08|-0.13|0.6553
72562697|NCT01396421|144657264|SUPERIORITY_OR_OTHER||Treatment difference|-0.03||||0.617|TWO_SIDED|95.0|-0.13|0.08||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|Week 1||||0.08|-0.13|0.6170
72454836|NCT01968967|144432901|SUPERIORITY_OR_OTHER||LS Mean Difference|-51.8|STANDARD_ERROR_OF_MEAN|2.09|<|0.001|TWO_SIDED|95.0|-55.9|-47.7|||MMRM|||Week 12: LS mean difference and associated 95% CI and p-value were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region. An unstructured variance covariance matrix was used.||-47.7|-55.9|<0.001
72454837|NCT01968967|144432901|SUPERIORITY_OR_OTHER||LS Mean Difference|-44.0|STANDARD_ERROR_OF_MEAN|2.61|||TWO_SIDED|95.0|-49.1|-38.8||||||Week 24: LS mean difference and associated 95% CI were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region. An unstructured variance covariance matrix was used.||-38.8|-49.1|
72454838|NCT01968967|144432901|SUPERIORITY_OR_OTHER||LS Mean Difference|-34.6|STANDARD_ERROR_OF_MEAN|2.83|||TWO_SIDED|95.0|-40.2|-29.0||||||Week 52: LS mean difference and associated 95% CI were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region. An unstructured variance covariance matrix was used.||-29.0|-40.2|
72454839|NCT01968967|144432902|SUPERIORITY_OR_OTHER||LS Mean Difference|-28.5|STANDARD_ERROR_OF_MEAN|3.04|<|0.001|TWO_SIDED|95.0|-34.4|-22.5|||MMRM|||Week 12: LS mean difference and associated 95% CI and p-value were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-22.5|-34.4|<0.001
72454840|NCT01968967|144432902|SUPERIORITY_OR_OTHER||LS Mean Difference|-31.1|STANDARD_ERROR_OF_MEAN|4.86|||TWO_SIDED|95.0|-40.6|-21.5||||||Week 24: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-21.5|-40.6|
72454841|NCT01968967|144432902|SUPERIORITY_OR_OTHER||LS Mean Difference|-25.3|STANDARD_ERROR_OF_MEAN|5.89|||TWO_SIDED|95.0|-36.8|-13.7||||||Week 52: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-13.7|-36.8|
72499821|NCT01147809|144530036|SUPERIORITY_OR_OTHER||Percent difference|12.9||||0.407|TWO_SIDED|95.0|-15.6|51.1|||ANCOVA|||||51.1|-15.6|0.407
72499822|NCT01147809|144530037|SUPERIORITY_OR_OTHER||Percent difference|-4.4||||0.802|TWO_SIDED|95.0|-33.5|37.4|||ANCOVA|||||37.4|-33.5|0.802
72499823|NCT01307423|144530045|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|12.1||||0.0062|TWO_SIDED|95.0|3.5|20.7|||Chi-squared||Two-sided 95% CI of the proportion difference is based on the normal approximation to the binomial distribution.|In order to maintain the Type 1 error at the 0.05 significance level, the Hochberg procedure was to be used. The results of the endpoint were to be considered statistically significant if both the 30 mg apremilast dose versus placebo comparison and the 20 mg versus placebo comparison were statistically significant at the 0.05 significance level, or one of the comparisons was statistically significant at the 0.025 level.||20.7|3.5|0.0062
72562698|NCT01396421|144657264|SUPERIORITY_OR_OTHER||Treatment difference|0.03||||0.6446|TWO_SIDED|95.0|-0.1|0.15||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates..|Mixed Models Analysis|Week 1||||0.15|-0.10|0.6446
72562699|NCT01396421|144657264|SUPERIORITY_OR_OTHER||Treatment difference|-0.15||||0.0347|TWO_SIDED|95.0|-0.29|-0.01||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|Week 2||||-0.01|-0.29|0.0347
72620406|NCT00507507|144772167|SUPERIORITY_OR_OTHER|||||||0.119||||||A Fisher exact test with a 0.05 two-sided significance level was used.|Fisher Exact|||Analysis at Week 144: the null hypothesis was that there was no difference in the proportion of subjects with seroconversion to anti-HBe between the Tenofovir DF and FTC+Tenofovir DF groups; the alternative hypothesis was that there was a difference.||||0.119
72499824|NCT01307423|144530045|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|14.8||||0.001|TWO_SIDED|95.0|6.1|23.5|||Chi-squared||Two-sided 95% CI of the proportion difference is based on the normal approximation to the binomial distribution.|In order to maintain the Type 1 error at the 0.05 significance level, the Hochberg procedure was to be used. The results of the endpoint were to be considered statistically significant if both the 30 mg apremilast dose versus placebo comparison and the 20 mg versus placebo comparison were statistically significant at the 0.05 significance level, or one of the comparisons was statistically significant at the 0.025 level.||23.5|6.1|0.0010
72499825|NCT01307423|144530046|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.168||||0.0008|TWO_SIDED|95.0|-0.265|-0.071|||ANCOVA|Based on an analysis of covariance (ANCOVA) model with treatment group as a factor, and the baseline value as a covariate.||Pairwise comparisons (30 mg vs placebo and 20 mg vs placebo) were conducted conditional on the primary endpoint results. If the primary endpoint was statistically significant for both apremilast dose groups, pairwise comparisons for the HAQ-DI were to be evaluated at the 0.05 level using the Hochberg procedure. If only one apremilast dose was statistically significant, then only the comparison between that apremilast dose and placebo was conducted for the HAQ-DI score, at the 0.025 level.||-0.071|-0.265|0.0008
72391832|NCT00256750|144290856|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|1.7||||0.0992|TWO_SIDED|95.0|-0.3|3.8|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Vitality, Month 24||3.8|-0.3|0.0992
72562700|NCT01396421|144657264|SUPERIORITY_OR_OTHER||Leasr squares mean|-0.12||||0.0825|TWO_SIDED|95.0|-0.27|0.02||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|||||0.02|-0.27|0.0825
72620407|NCT00507507|144772167|SUPERIORITY_OR_OTHER|||||||0.244||||||A Fisher exact test with a 0.05 two-sided significance level was used.|Fisher Exact|||Analysis at Week 192: the null hypothesis was that there was no difference in the proportion of subjects with seroconversion to anti-HBe between the Tenofovir DF and FTC+Tenofovir DF groups; the alternative hypothesis was that there was a difference.||||0.244
72391833|NCT00256750|144290856|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|2.3||||0.0339|TWO_SIDED|95.0|0.2|4.4|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Bodily Pain, Month 36||4.4|0.2|0.0339
72454842|NCT01968967|144432903|SUPERIORITY_OR_OTHER||LS Mean Difference|5.8|STANDARD_ERROR_OF_MEAN|0.63|<|0.001|TWO_SIDED|95.0|4.5|7.0|||MMRM|||Week 12: LS mean difference and associated 95% CI and p-value were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||7.0|4.5|<0.001
72454843|NCT01968967|144432903|SUPERIORITY_OR_OTHER||LS Mean Difference|5.5|STANDARD_ERROR_OF_MEAN|0.67|||TWO_SIDED|95.0|4.2|6.8||||||Week 24: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||6.8|4.2|
72454844|NCT01968967|144432903|SUPERIORITY_OR_OTHER||LS Mean Difference|5.2|STANDARD_ERROR_OF_MEAN|0.76|||TWO_SIDED|95.0|3.7|6.7||||||Week 52: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||6.7|3.7|
72454845|NCT01968967|144432904|SUPERIORITY_OR_OTHER||LS Mean Difference|-50.7|STANDARD_ERROR_OF_MEAN|1.34|||TWO_SIDED|95.0|-53.3|-48.0||||||Week 24: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-48.0|-53.3|
72454846|NCT01968967|144432904|SUPERIORITY_OR_OTHER||LS Mean Difference|-40.7|STANDARD_ERROR_OF_MEAN|1.46|||TWO_SIDED|95.0|-43.5|-37.8||||||Week 52: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-37.8|-43.5|
72454847|NCT01968967|144432905|SUPERIORITY_OR_OTHER||LS Mean Difference|-16.6|STANDARD_ERROR_OF_MEAN|1.73|||TWO_SIDED|95.0|-20.0|-13.2||||||Week 12: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-13.2|-20.0|
72454848|NCT01968967|144432905|SUPERIORITY_OR_OTHER||LS Mean Difference|-16.7|STANDARD_ERROR_OF_MEAN|2.05|||TWO_SIDED|95.0|-20.7|-12.6||||||Week 24: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-12.6|-20.7|
72454849|NCT01968967|144432905|SUPERIORITY_OR_OTHER||LS Mean Difference|-12.8|STANDARD_ERROR_OF_MEAN|1.91|||TWO_SIDED|95.0|-16.5|-9.0||||||Week 52: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-9.0|-16.5|
72454850|NCT01968967|144432906|SUPERIORITY_OR_OTHER||LS Mean Difference|3.4|STANDARD_ERROR_OF_MEAN|0.49|||TWO_SIDED|95.0|2.4|4.3||||||Week 12: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||4.3|2.4|
72562701|NCT01396421|144657264|SUPERIORITY_OR_OTHER||Treatment difference|0.12||||0.1678|TWO_SIDED|95.0|-0.05|0.3||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|Week 2||||0.30|-0.05|0.1678
72562702|NCT01396421|144657264|SUPERIORITY_OR_OTHER||Treatment difference|-0.21||||0.0219|TWO_SIDED|95.0|-0.39|-0.03||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|Week 3||||-0.03|-0.39|0.0219
72562703|NCT01396421|144657264|SUPERIORITY_OR_OTHER||Least squares mean|-0.09||||0.3275|TWO_SIDED|95.0|-0.27|0.09||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|Week 3||||0.09|-0.27|0.3275
72562704|NCT01396421|144657264|SUPERIORITY_OR_OTHER||Treatment difference|0.18||||0.1173|TWO_SIDED|95.0|-0.04|0.4||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|Week 3||||0.40|-0.04|0.1173
72562705|NCT01396421|144657264|SUPERIORITY_OR_OTHER||Treatment difference|-0.42|||<|0.0001|TWO_SIDED|95.0|-0.63|-0.21||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|Week 4||||-0.21|-0.63|<0.0001
72562706|NCT01396421|144657264|SUPERIORITY_OR_OTHER||Least squares mean|-0.19||||0.0662|TWO_SIDED|95.0|-0.4|0.01||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|Week 4||||0.01|-0.40|0.0662
72562707|NCT01396421|144657264|SUPERIORITY_OR_OTHER||Treatment difference|-0.04||||0.7587|TWO_SIDED|95.0|-0.3|0.22||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|Week 4||||0.22|-0.30|0.7587
72562708|NCT01396421|144657264|SUPERIORITY_OR_OTHER||Treatment difference|-0.39||||0.0006|TWO_SIDED|95.0|-0.61|-0.17||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|Week 5||||-0.17|-0.61|0.0006
72562709|NCT01396421|144657264|SUPERIORITY_OR_OTHER||Least squares mean|-0.34||||0.0032|TWO_SIDED|95.0|-0.56|-0.11||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|Week 5||||-0.11|-0.56|0.0032
72562710|NCT01396421|144657264|SUPERIORITY_OR_OTHER||Treatment difference|-0.04||||0.7619|TWO_SIDED|95.0|-0.32|0.23||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|Week 5||||0.23|-0.32|0.7619
72562711|NCT01396421|144657265|SUPERIORITY_OR_OTHER||Treatment difference|2.46||||0.0557|TWO_SIDED|95.0|-0.06|4.98||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|Week 6||||4.98|-0.06|0.0557
72454851|NCT01968967|144432906|SUPERIORITY_OR_OTHER||LS Mean Difference|3.5|STANDARD_ERROR_OF_MEAN|0.51|||TWO_SIDED|95.0|2.5|4.5||||||Week 24: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||4.5|2.5|
72454852|NCT01968967|144432906|SUPERIORITY_OR_OTHER||LS Mean Difference|3.8|STANDARD_ERROR_OF_MEAN|0.57|||TWO_SIDED|95.0|2.7|4.9||||||Week 52: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||4.9|2.7|
72499826|NCT01307423|144530046|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.217|||<|0.0001|TWO_SIDED|95.0|-0.314|-0.12|||ANCOVA|Based on an analysis of covariance (ANCOVA) model with treatment group as a factor, and the baseline value as a covariate||Pairwise comparisons (30 mg vs placebo and 20 mg vs placebo) were conducted conditional on the primary endpoint results. If the primary endpoint was statistically significant for both apremilast dose groups, pairwise comparisons for the HAQ-DI were to be evaluated at the 0.05 level using the Hochberg procedure. If only one apremilast dose was statistically significant, then only the comparison between that apremilast dose and placebo was conducted for the HAQ-DI score, at the 0.025 level.||-0.120|-0.314|<.0001
72499827|NCT01307423|144530047|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|16.1||||0.0002|TWO_SIDED|95.0|7.7|24.4||Secondary endpoints from the placebo-controlled period (Weeks 16 and 24) were analyzed in a hierarchical fashion to control the Type I error rate as described above|Chi-squared||Two-sided 95% CI of the proportion difference is based on the normal approximation to the binomial distribution.|||24.4|7.7|0.0002
72499828|NCT01307423|144530047|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|11.4||||0.0063|TWO_SIDED|95.0|3.3|19.4||Secondary endpoints from the placebo-controlled period (Weeks 16 and 24) were analyzed in a hierarchical fashion to control the Type I error rate as described above|Chi-squared||Two-sided 95% CI of the proportion difference is based on the normal approximation to the binomial distribution.|||19.4|3.3|0.0063
72499829|NCT01307423|144530048|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.168||||0.0014|TWO_SIDED|95.0|-0.271|-0.065||Secondary endpoints from the placebo-controlled period (Weeks 16 and 24) were analyzed in a hierarchical fashion to control the Type I error rate as described above|ANCOVA|Based on an analysis of covariance model for the change from baseline at Week 24, with treatment group as a factor and baseline value as a covariate||||-0.065|-0.271|0.0014
72499830|NCT01307423|144530048|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.219|||<|0.0001|TWO_SIDED|95.0|-0.322|-0.117||Secondary endpoints from the placebo-controlled period (Weeks 16 and 24) were analyzed in a hierarchical fashion to control the Type I error rate as described above|ANCOVA|Based on an analysis of covariance model for the change from baseline at Week 24, with treatment group as a factor and baseline value as a covariate||||-0.117|-0.322|<.0001
72499831|NCT01307423|144530049|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|2.38||||0.0043|TWO_SIDED|95.0|0.75|4.01||Secondary endpoints from the placebo-controlled period (Weeks 16 and 24) were analyzed in a hierarchical fashion to control the Type I error rate as described above.|ANCOVA|Based on an analysis of covariance model for the change from baseline at Week 16, with treatment group as a factor and baseline value as a covariate||||4.01|0.75|0.0043
72499832|NCT01307423|144530049|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|3.18||||0.0002|TWO_SIDED|95.0|1.55|4.82||Secondary endpoints from the placebo-controlled period (Weeks 16 and 24) were analyzed in a hierarchical fashion to control the Type I error rate as described above|ANCOVA|Based on an analysis of covariance model for the change from baseline at Week 16, with treatment group as a factor and baseline value as a covariate||||4.82|1.55|0.0002
72499833|NCT01307423|144530050|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|14.4||||0.0037|TWO_SIDED|95.0|4.8|24.0||Secondary endpoints from the placebo-controlled period (Weeks 16 and 24) were analyzed in a hierarchical fashion to control the Type I error rate as described above.|Chi-squared||Two-sided 95% CI of the proportion difference is based on the normal approximation to the binomial distribution.|||24.0|4.8|0.0037
72499834|NCT01307423|144530050|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|21.0|||<|0.0001|TWO_SIDED|95.0|11.3|30.7||Secondary endpoints from the placebo-controlled period (Weeks 16 and 24) were analyzed in a hierarchical fashion to control the Type I error rate as described above.|Chi-squared||Two-sided 95% CI of the proportion difference is based on the normal approximation to the binomial distribution.|||30.7|11.3|<.0001
72499835|NCT01307423|144530051|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-5.0||||0.0485|TWO_SIDED|95.0|-10.0|0.0||Secondary endpoints from the placebo-controlled period (Weeks 16 and 24) were analyzed in a hierarchical fashion to control the Type I error rate as described above|ANCOVA|Based on an analysis of covariance (ANCOVA) model with treatment group as a factor, and the baseline value as a covariate||||-0.0|-10.0|0.0485
72562712|NCT01396421|144657265|SUPERIORITY_OR_OTHER||Treatment difference|2.89||||0.025|TWO_SIDED|95.0|0.37|5.42||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|Week 6||||5.42|0.37|0.0250
72562713|NCT01396421|144657265|SUPERIORITY_OR_OTHER||Treatment difference|1.58||||0.3264|TWO_SIDED|95.0|-1.58|4.74||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|Week 6||||4.74|-1.58|0.3264
72499836|NCT01307423|144530051|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-7.8||||0.0022|TWO_SIDED|95.0|-12.8|-2.8||Secondary endpoints from the placebo-controlled period (Weeks 16 and 24) were analyzed in a hierarchical fashion to control the Type I error rate as described above|ANCOVA|Based on an analysis of covariance (ANCOVA) model with treatment group as a factor, and the baseline value as a covariate||||-2.8|-12.8|0.0022
72499837|NCT01307423|144530052|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.1||||0.7696|TWO_SIDED|95.0|-0.8|0.6|||ANCOVA||Based on an analysis of covariance model for the change from baseline at Week 16, with treatment group as a factor and the baseline value as a covariate|||0.6|-0.8|0.7696
72454853|NCT01968967|144432907|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|0.59|||TWO_SIDED|95.0|-0.9|1.4||||||Week 12: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||1.4|-0.9|
72454854|NCT01968967|144432907|SUPERIORITY_OR_OTHER||LS Mean Difference|1.1|STANDARD_ERROR_OF_MEAN|0.61|||TWO_SIDED|95.0|-0.1|2.3||||||Week 24: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||2.3|-0.1|
72454855|NCT01968967|144432907|SUPERIORITY_OR_OTHER||LS Mean Difference|1.5|STANDARD_ERROR_OF_MEAN|0.61|||TWO_SIDED|95.0|0.3|2.7||||||Week 52: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||2.7|0.3|
72454856|NCT01968967|144432908|SUPERIORITY_OR_OTHER||LS Mean Difference|-16.6|STANDARD_ERROR_OF_MEAN|1.73|||TWO_SIDED|95.0|-20.0|-13.2||||||Week 12: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-13.2|-20.0|
72454857|NCT01968967|144432908|SUPERIORITY_OR_OTHER||LS Mean Difference|-16.7|STANDARD_ERROR_OF_MEAN|2.05|||TWO_SIDED|95.0|-20.7|-12.6||||||Week 24: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-12.6|-20.7|
72454858|NCT01968967|144432908|SUPERIORITY_OR_OTHER||LS Mean Difference|-12.8|STANDARD_ERROR_OF_MEAN|1.91|||TWO_SIDED|95.0|-16.5|-9.0||||||Week 52: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-9.0|-16.5|
72454859|NCT01968967|144432909|SUPERIORITY_OR_OTHER||LS Mean Difference|-60.4|STANDARD_ERROR_OF_MEAN|1.4|||TWO_SIDED|95.0|-63.1|-57.6||||||LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region. An unstructured variance covariance matrix was used.||-57.6|-63.1|
72454860|NCT01968967|144432910|SUPERIORITY_OR_OTHER||LS Mean Difference|-62.8|STANDARD_ERROR_OF_MEAN|2.8|||TWO_SIDED|95.0|-68.3|-57.3||||||LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region. An unstructured variance covariance matrix was used.||-57.3|-68.3|
72454861|NCT01968967|144432911|SUPERIORITY_OR_OTHER||LS Mean Difference|-61.0|STANDARD_ERROR_OF_MEAN|1.27|||TWO_SIDED|95.0|-63.5|-58.5||||||LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-58.5|-63.5|
72499838|NCT01307423|144530052|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.0||||0.0038|TWO_SIDED|95.0|-1.7|-0.3||Secondary endpoints from the placebo-controlled period (Weeks 16 and 24) were analyzed in a hierarchical fashion to control the Type I error rate as described above|ANCOVA||Based on an analysis of covariance model for the change from baseline at Week 16, with treatment group as a factor and the baseline value as a covariate|||-0.3|-1.7|0.0038
72499839|NCT01307423|144530053|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.9|||||TWO_SIDED|95.0|-1.6|-0.2|||||Based on analysis of covariance model for the change from baseline at Week 16, with treatment group as a factor and the baseline value as a covariate|||-0.2|-1.6|
72562714|NCT01396421|144657266|SUPERIORITY_OR_OTHER||Treatment difference|-2.44||||0.001|TWO_SIDED|95.0|-3.88|-0.99||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|||||-0.99|-3.88|0.0010
72454862|NCT01968967|144432912|SUPERIORITY_OR_OTHER||LS Mean Difference|-63.7|STANDARD_ERROR_OF_MEAN|1.46|||TWO_SIDED|95.0|-66.6|-60.9||||||LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-60.9|-66.6|
72454863|NCT01968967|144432913|SUPERIORITY_OR_OTHER||LS Mean Difference|-66.4|STANDARD_ERROR_OF_MEAN|1.46|||TWO_SIDED|95.0|-69.3|-63.6||||||LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-63.6|-69.3|
72454864|NCT01968967|144432914|SUPERIORITY_OR_OTHER||LS Mean Difference|-45.8|STANDARD_ERROR_OF_MEAN|0.97|||TWO_SIDED|95.0|-47.7|-43.9||||||LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-43.9|-47.7|
72499840|NCT01307423|144530053|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.7|||||TWO_SIDED|95.0|-1.4|0.0|||||Based on analysis of covariance model for the change from baseline at Week 16, with treatment group as a factor and the baseline value as a covariate|||-0.0|-1.4|
72499841|NCT01307423|144530054|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-4.91|||||TWO_SIDED|95.0|-7.04|-2.78|||||Based on analysis of covariance model for the change from baseline at Week 16, with treatment group as a factor and the baseline value as a covariate|||-2.78|-7.04|
72562715|NCT01396421|144657266|SUPERIORITY_OR_OTHER||Treatment difference|-2.22||||0.0029|TWO_SIDED|95.0|-3.67|-0.77||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|||||-0.77|-3.67|0.0029
72454865|NCT01968967|144432915|SUPERIORITY_OR_OTHER||LS Mean Difference|-10.6|STANDARD_ERROR_OF_MEAN|0.63|||TWO_SIDED|95.0|-11.8|-9.3||||||LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-9.3|-11.8|
72454866|NCT01968967|144432916|SUPERIORITY_OR_OTHER||LS Mean Difference|2.7|STANDARD_ERROR_OF_MEAN|0.31|||TWO_SIDED|95.0|2.1|3.3||||||LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||3.3|2.1|
72454867|NCT01968967|144432917|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.6|STANDARD_ERROR_OF_MEAN|0.04|||TWO_SIDED|95.0|-1.6|-1.5||||||Week 12: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-1.5|-1.6|
72454868|NCT01968967|144432917|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.4|STANDARD_ERROR_OF_MEAN|0.05|||TWO_SIDED|95.0|-1.5|-1.3||||||Week 24: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-1.3|-1.5|
72454869|NCT01968967|144432917|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|0.05|||TWO_SIDED|95.0|-1.2|-1.0||||||Week 52: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-1.0|-1.2|
72454870|NCT01968967|144432918|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.01|||TWO_SIDED|95.0|-0.3|-0.3||||||Week 12: LS mean difference and associated 95% confidence interval CI were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-0.3|-0.3|
72454871|NCT01968967|144432918|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.01|||TWO_SIDED|95.0|-0.3|-0.3||||||Week 24: LS mean difference and associated 95% confidence interval CI were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-0.3|-0.3|
72454872|NCT01968967|144432918|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.01|||TWO_SIDED|95.0|-0.3|-0.2||||||Week 52: LS mean difference and associated 95% confidence interval CI were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-0.2|-0.3|
72454873|NCT01968967|144432919|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|27.0|||||TWO_SIDED|95.0|19.21|38.02||||||Week 12: Odds ratio, associated 95% CI were derived from a logistic regression model with fixed effects for treatment group, baseline value, geographical region and triglyceride subgroup.||38.02|19.21|
72454874|NCT01968967|144432919|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|12.9|||||TWO_SIDED|95.0|9.84|16.86||||||Week 24: Odds ratio, associated 95% CI were derived from a logistic regression model with fixed effects for treatment group, baseline value, geographical region and triglyceride subgroup.||16.86|9.84|
72454875|NCT01968967|144432919|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.3|||||TWO_SIDED|95.0|4.99|8.06||||||Week 52: Odds ratio, associated 95% CI were derived from a logistic regression model with fixed effects for treatment group, baseline value, geographical region and triglyceride subgroup.||8.06|4.99|
72562716|NCT01396421|144657266|SUPERIORITY_OR_OTHER||Treatment difference|-1.11||||0.2227|TWO_SIDED|95.0|-2.9|0.68||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|||||0.68|-2.90|0.2227
72562717|NCT01396421|144657267|SUPERIORITY_OR_OTHER||Treatment difference|-1.41||||0.0069|TWO_SIDED|95.0|-2.44|0.39||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|||||0.39|-2.44|0.0069
72562718|NCT01396421|144657267|SUPERIORITY_OR_OTHER||Least squares mean|-1.78||||0.0007|TWO_SIDED|95.0|-2.81|-0.76||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|||||-0.76|-2.81|0.0007
72562719|NCT01396421|144657267|SUPERIORITY_OR_OTHER||Treatmetn difference|-1.07||||0.0996|TWO_SIDED|95.0|-2.33|0.2||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|||||0.20|-2.33|0.0996
72562720|NCT01396421|144657268|SUPERIORITY_OR_OTHER||Treatment difference|-0.5||||0.0004|TWO_SIDED|95.0|-0.77|-0.22||The Cochran-Mantel-Haenzel (CMH) row mean scores differ test controlling for trial center was applied to CGI-I score.|Cochran-Mantel-Haenszel|||||-0.22|-0.77|0.0004
72562721|NCT01396421|144657268|SUPERIORITY_OR_OTHER||Treatment difference|-0.54||||0.0002|TWO_SIDED|95.0|-0.82|-0.26||The CMH row mean scores differ test controlling for trial center was applied to CGI-I score.|Cochran-Mantel-Haenszel|||||-0.26|-0.82|0.0002
72562722|NCT01396421|144657268|SUPERIORITY_OR_OTHER||Treatment difference|-0.14||||0.4505|TWO_SIDED|95.0|-0.5|0.22||The CMH row mean scores differ test controlling for trial center was applied to CGI-I score.|Cochran-Mantel-Haenszel|||||0.22|-0.50|0.4505
72562723|NCT01396421|144657269|SUPERIORITY_OR_OTHER||Relative risk|1.48||||0.0032|TWO_SIDED|95.0|1.14|1.91||CMH general association test controlling for trial was applied to the analysis of response rate.|Cochran-Mantel-Haenszel|||||1.91|1.14|0.0032
72562724|NCT01396421|144657269|SUPERIORITY_OR_OTHER||Relative risk|1.59||||0.0004|TWO_SIDED|95.0|1.23|2.05||CMH general association test controlling for trial was applied to the analysis of response rate.|Cochran-Mantel-Haenszel|||||2.05|1.23|0.0004
72562725|NCT01396421|144657269|SUPERIORITY_OR_OTHER||Relative risk|1.27||||0.1576|TWO_SIDED|95.0|0.92|1.76||CMH general association test controlling for trial was applied to the analysis of response rate.|Cochran-Mantel-Haenszel|||||1.76|0.92|0.1576
72454876|NCT01968967|144432920|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|86.5|||||TWO_SIDED|95.0|61.74|121.25||||||Week 12: Odds ratio, associated 95% CI were derived from a logistic regression model with fixed effects for treatment group, baseline value, geographical region and triglyceride subgroup.||121.25|61.74|
72622480|NCT00392288|144774960|SUPERIORITY_OR_OTHER|||||||0.0703||95.0||||Due to usage of a-priori ordered hypotheses, adjustment of p-values is not necessary. The pre-specified significance level was 0.05. The tests were carried out two-sided.|ANCOVA|ANCOVA model: Change in FEV1 = baseline FEV1 + age \[yrs\] + treatment + pooled center + previous corticosteroid therapy + holding chamber||This is an analysis of the change from baseline to week 12 or last visit. A t-test was used to compare the least-square means of Ciclesonide 80 versus Placebo.||||0.0703
72391834|NCT00256750|144290856|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|1.0||||0.3572|TWO_SIDED|95.0|-1.1|3.1|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Bodily Pain, Month 36||3.1|-1.1|0.3572
72454877|NCT01968967|144432920|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|35.9|||||TWO_SIDED|95.0|26.83|47.96||||||Week 24: Odds ratio, associated 95% CI were derived from a logistic regression model with fixed effects for treatment group, baseline value, geographical region and triglyceride subgroup.||47.96|26.83|
72454878|NCT01968967|144432920|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|25.5|||||TWO_SIDED|95.0|18.9|34.47||||||Week 52: Odds ratio, associated 95% CI were derived from a logistic regression model with fixed effects for treatment group, baseline value, geographical region and triglyceride subgroup.||34.47|18.90|
72391835|NCT00256750|144290856|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|2.3||||0.0211|TWO_SIDED|95.0|0.3|4.2|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|General Health, Month 36||4.2|0.3|0.0211
72391836|NCT00256750|144290856|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|2.0||||0.045|TWO_SIDED|95.0|0.0|4.0|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|General Health, Month 36||4.0|0.0|0.0450
72391837|NCT00256750|144290856|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|1.5||||0.171|TWO_SIDED|95.0|-0.7|3.7|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Mental Health, Month 36||3.7|-0.7|0.1710
72391838|NCT00256750|144290856|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|1.3||||0.2484|TWO_SIDED|95.0|-0.9|3.6|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Mental Health, Month 36||3.6|-0.9|0.2484
72391839|NCT00256750|144290856|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|1.3||||0.1836|TWO_SIDED|95.0|-0.6|3.2|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Physical Functioning, Month 36||3.2|-0.6|0.1836
72391840|NCT00256750|144290856|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|1.0||||0.3303|TWO_SIDED|95.0|-1.0|2.9|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Physical Functioning, Month 36||2.9|-1.0|0.3303
72391841|NCT00256750|144290856|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|2.5||||0.0299|TWO_SIDED|95.0|0.2|4.8|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Role Emotional, Month 36||4.8|0.2|0.0299
72391842|NCT00256750|144290856|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|1.9||||0.1141|TWO_SIDED|95.0|-0.4|4.2|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Role Emotional, Month 36||4.2|-0.4|0.1141
72391843|NCT00256750|144290856|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|2.7||||0.0087|TWO_SIDED|95.0|0.7|4.7|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Role-Physical, Month 36||4.7|0.7|0.0087
72391844|NCT00256750|144290856|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|2.6||||0.0128|TWO_SIDED|95.0|0.6|4.7|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Role-Physical, Month 36||4.7|0.6|0.0128
72391845|NCT00256750|144290856|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|1.5||||0.1369|TWO_SIDED|95.0|-0.5|3.5|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Social Functioning, Month 36||3.5|-0.5|0.1369
72391846|NCT00256750|144290856|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|0.5||||0.6331|TWO_SIDED|95.0|-1.5|2.5|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Social Functioning, Month 36||2.5|-1.5|0.6331
72391847|NCT00256750|144290856|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|2.2||||0.0361|TWO_SIDED|95.0|0.1|4.3|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Vitality, Month 36||4.3|0.1|0.0361
72391848|NCT00256750|144290856|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|2.1||||0.0525|TWO_SIDED|95.0|0.0|4.2|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Vitality, Month 36||4.2|-0.0|0.0525
72391849|NCT00256750|144290857|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|-0.024|||<|0.0001|TWO_SIDED|95.0|-0.032|-0.015||Missing data were imputed by LOCF. The ridit of the reference group is by definition 0.5.|z-test|The obtained ridits between treatment groups will be compared using z-test at 0.05 significance level for each year.||Symptom Distress, Month 6. For calculation of symptom distress, those symptoms that never occurred will be converted to missing values, in order to avoid anticipatory symptom distress.||-0.015|-0.032|<0.0001
72454879|NCT00087022|144432951|SUPERIORITY|||||||0.737|||||||Log Rank|||||||0.737
72454880|NCT00087022|144432952|SUPERIORITY|||||||1.012|||||||Log Rank|||||||1.012
72454881|NCT00087022|144432955|SUPERIORITY|||||||0.022|||||||Log Rank|||||||0.022
72499842|NCT01307423|144530054|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-5.65|||||TWO_SIDED|95.0|-7.78|-3.51|||||Based on analysis of covariance model for the change from baseline at Week 16, with treatment group as a factor and the baseline value as a covariate|||-3.51|-7.78|
72391850|NCT00256750|144290857|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|-0.019|||<|0.0001|TWO_SIDED|95.0|-0.028|-0.011||Missing data were imputed by LOCF. The ridit of the reference group is by definition 0.5.|z-test|The obtained ridits between treatment groups will be compared using z-test at 0.05 significance level for each year.||Symptom Distress, Month 6. For calculation of symptom distress, those symptoms that never occurred will be converted to missing values, in order to avoid anticipatory symptom distress.||-0.011|-0.028|<0.0001
72391851|NCT00256750|144290857|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|-0.023|||<|0.0001|TWO_SIDED|95.0|-0.031|-0.014||Missing data were imputed by LOCF. The ridit of the reference group is by definition 0.5.|z-test|The obtained ridits between treatment groups will be compared using z-test at 0.05 significance level for each year.||Symptom Occurrence, Month 6.||-0.014|-0.031|<0.0001
72391852|NCT00256750|144290857|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|-0.026|||<|0.0001|TWO_SIDED|95.0|-0.035|-0.017||Missing data were imputed by LOCF. The ridit of the reference group is by definition 0.5.|z-test|The obtained ridits between treatment groups will be compared using z-test at 0.05 significance level for each year.||Symptom Occurrence, Month 6.||-0.017|-0.035|<0.0001
72620408|NCT01623154|144772185|NON_INFERIORITY_OR_EQUIVALENCE|While 40 subjects is the min req by the NCCLS guideline on method comparison (EP9-A2), we proposed to enroll a min of 60 evaluable pediatric subjects (max of 80) with at least 20 of them having a UHR value of ≥ 10.0µg/min. The expected # of positive cases is 20-30% of the subjects enrolled, we anticipated that 80 eval subj would give approximately 20 subj with a pos UHR value. The anticipated % pos/neg agreement between the 2 instruments is 95% bases on data from the adult population.|Slope|0.99|||||TWO_SIDED|95.0|0.987|0.993||95% confidence interval is used instead of p-value.|Deming Regression|Analyses to determine the comparability between UHR \& DOB values from the 2 instruments included Deming, Passing-Bablok and regular regressions.|95% confidence interval is used instead of p-value.|||0.993|0.987|
72620409|NCT01623154|144772185|NON_INFERIORITY_OR_EQUIVALENCE|While 40 subjects is the min req by the NCCLS guideline on method comparison (EP9-A2), we proposed to enroll a min of 60 evaluable pediatric subjects (max of 80) with at least 20 of them having a UHR value of ≥ 10.0µg/min. The expected # of positive cases is 20-30% of the subjects enrolled, we anticipated that 80 eval subj would give approximately 20 subj with a pos UHR value. The anticipated % pos/neg agreement between the 2 instruments is 95% bases on data from the adult population.|Intercept|-0.04|||||TWO_SIDED|95.0|-0.25|0.17|||Deming Regression|Analyses to determine the comparability between UHR \& DOB values from the 2 instruments included Deming, Passing-Bablok and regular regressions.|95% confidence interval is used instead of p-value.|||0.17|-0.25|
72620410|NCT01623154|144772185|NON_INFERIORITY_OR_EQUIVALENCE|While 40 subjects is the min req by the NCCLS guideline on method comparison (EP9-A2), we proposed to enroll a min of 60 evaluable pediatric subjects (max of 80) with at least 20 of them having a UHR value of ≥ 10.0µg/min. The expected # of positive cases is 20-30% of the subjects enrolled, we anticipated that 80 eval subj would give approximately 20 subj with a pos UHR value. The anticipated % pos/neg agreement between the 2 instruments is 95% bases on data from the adult population.|Slope|0.99|||||TWO_SIDED|95.0|0.987|0.993|||Regression, Linear|Analyses to determine the comparability between UHR \& DOB values from the 2 instruments included Deming, Passing-Bablok and regular regressions.|95% confidence interval is used instead of p-value.|||0.993|0.987|
72620411|NCT01623154|144772185|NON_INFERIORITY_OR_EQUIVALENCE|While 40 subjects is the min req by the NCCLS guideline on method comparison (EP9-A2), we proposed to enroll a min of 60 evaluable pediatric subjects (max of 80) with at least 20 of them having a UHR value of ≥ 10.0µg/min. The expected # of positive cases is 20-30% of the subjects enrolled, we anticipated that 80 eval subj would give approximately 20 subj with a pos UHR value. The anticipated % pos/neg agreement between the 2 instruments is 95% bases on data from the adult population.|Intercept|-0.03|||||TWO_SIDED|95.0|-0.24|0.18|||Regression, Linear|Analyses to determine the comparability between UHR \& DOB values from the 2 instruments included Deming, Passing-Bablok and regular regressions.|95% confidence interval is used instead of p-value.|||0.18|-0.24|
72620412|NCT01623154|144772185|NON_INFERIORITY_OR_EQUIVALENCE|While 40 subjects is the min req by the NCCLS guideline on method comparison (EP9-A2), we proposed to enroll a min of 60 evaluable pediatric subjects (max of 80) with at least 20 of them having a UHR value of ≥ 10.0µg/min. The expected # of positive cases is 20-30% of the subjects enrolled, we anticipated that 80 eval subj would give approximately 20 subj with a pos UHR value. The anticipated % pos/neg agreement between the 2 instruments is 95% bases on data from the adult population.|Slope|0.995|||||TWO_SIDED|95.0|0.99|1.0|||Passing-Bablock|Analyses to determine the comparability between UHR \& DOB values from the 2 instruments included Deming, Passing-Bablok and regular regressions.|95% confidence interval is used instead of p-value.|||1.000|0.990|
72620413|NCT01623154|144772185|NON_INFERIORITY_OR_EQUIVALENCE|Analyses to determine the comparability between UHR \& DOB values from the 2 instruments included Deming, Passing-Bablok and regular regressions.|Intercept|-0.04|||||TWO_SIDED|95.0|-0.3|0.01|||Passing-Bablok|Analyses to determine the comparability between UHR \& DOB values from the 2 instruments included Deming, Passing-Bablok and regular regressions.|95% confidence interval is used instead of p-value.|While 40 subjects is the min req by the NCCLS guideline on method comparison (EP9-A2), we proposed to enroll a min of 60 evaluable pediatric subjects (max of 80) with at least 20 of them having a UHR value of ≥ 10.0µg/min. The expected # of positive cases is 20-30% of the subjects enrolled, we anticipated that 80 eval subj would give approximately 20 subj with a pos UHR value. The anticipated % pos/neg agreement between the 2 instruments is 95% bases on data from the adult population.||0.01|-0.30|
72620414|NCT01623154|144772185|NON_INFERIORITY_OR_EQUIVALENCE|Described previously|Relative Sensitivity, %|100.0|||||TWO_SIDED|95.0|85.8|100.0|||||95% confidence interval is used instead of p-value.|Comparison of UHR Values obtained by UBit-IR300 and POCone were used to identify participants' H.pylori infection status. Participants with UHR value ≥ 10.0μg/min were considered positive for H.Pylori.||100|85.8|
72620415|NCT01623154|144772185|NON_INFERIORITY_OR_EQUIVALENCE|Provided previously|Relative Specificity, %|100.0|||||TWO_SIDED|95.0|94.9|100.0|||||95% confidence interval is used instead of p-value.|||100|94.9|
72454882|NCT02542943|144432986|SUPERIORITY_OR_OTHER||Least square (LS) mean difference|-0.13||||0.435|TWO_SIDED|95.0|-0.4|0.134||From ANCOVA model with treatment as factor and baseline Schiff score as covariate. For the Week 8 comparisons of the two test groups against the control group, Dunnett's multiplicity adjustment is applied.|ANCOVA||Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment. For Week 8 comparisons of the two test groups against the control group, Dunnett's multiplicity adjustment is applied.|||0.134|-0.400|0.4350
72454883|NCT02542943|144432986|SUPERIORITY_OR_OTHER||LS mean difference|0.07||||0.7605|TWO_SIDED|95.0|-0.192|0.34||From ANCOVA model with treatment as factor and baseline Schiff score as covariate. For the Week 8 comparisons of the two test groups against the control group, Dunnett's multiplicity adjustment is applied.|ANCOVA||Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment. For Week 8 comparisons of the two test groups against the control group, Dunnett's multiplicity adjustment is applied.|||0.340|-0.192|0.7605
72454884|NCT02542943|144432987|SUPERIORITY_OR_OTHER||LS mean difference|-0.21||||0.0873|TWO_SIDED|95.0|-0.445|0.031||From ANCOVA model with treatment as factor and baseline Schiff score as covariate.|ANCOVA||Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|||0.031|-0.445|0.0873
72454885|NCT02542943|144432988|SUPERIORITY_OR_OTHER||LS mean difference|-0.07||||0.4921|TWO_SIDED|95.0|-0.27|0.13||From ANCOVA model with treatment as factor and baseline Schiff score as covariate.|ANCOVA||Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|||0.130|-0.270|0.4921
72454886|NCT02542943|144432988|SUPERIORITY_OR_OTHER||LS mean difference|0.02||||0.8728|TWO_SIDED|95.0|-0.183|0.216||From ANCOVA model with treatment as factor and baseline Schiff score as covariate.|ANCOVA||Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|||0.216|-0.183|0.8728
72454887|NCT02542943|144432988|SUPERIORITY_OR_OTHER||LS mean difference|-0.09||||0.4003|TWO_SIDED|95.0|-0.287|0.115||From ANCOVA model with treatment as factor and baseline Schiff score as covariate.|ANCOVA||Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|||0.115|-0.287|0.4003
72454888|NCT02542943|144432989|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.0||||0.8106|TWO_SIDED|95.0|0.0|0.0||From Van Elteren test.|Van Elteren test||Median difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment. From non-parametric Hodges-Lehmann estimations.|||0.000|0.000|0.8106
72454889|NCT02542943|144432989|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.0||||0.1656|TWO_SIDED|95.0|-5.0|0.0||From Van Elteren test.|Van Elteren test||Median difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment. From non-parametric Hodges-Lehmann estimations.|||0.000|-5.000|0.1656
72454890|NCT02542943|144432989|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.0||||0.1419|TWO_SIDED|95.0|0.0|5.0|||Van Elteren test||Median difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment. From non-parametric Hodges-Lehmann estimations.|||5.000|0.000|0.1419
72454891|NCT02542943|144432990|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.0||||0.5631|TWO_SIDED|95.0|0.0|5.0||From Van Elteren test.|Van Elteren test||Median difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment. From non-parametric Hodges-Lehmann estimations.|||5.000|0.000|0.5631
72499843|NCT01307423|144530055|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.46|||<|0.0001|TWO_SIDED|95.0|-0.67|-0.25|||ANCOVA||Based on analysis of covariance model for the change from baseline at Week 16, with treatment group as a factor and the baseline value as a covariate|||-0.25|-0.67|<0.0001
72454892|NCT02542943|144432990|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.0||||0.8423|TWO_SIDED|95.0|0.0|0.0||From Van Elteren test.|Van Elteren test||Median difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment. From non-parametric Hodges-Lehmann estimations.|||0.000|0.000|0.8423
72454893|NCT02542943|144432990|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.0||||0.439|TWO_SIDED|95.0|0.0|5.0||From Van Elteren test.|Van Elteren test||Median difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment. From non-parametric Hodges-Lehmann estimations.|||5.000|0.000|0.4390
72454894|NCT02542943|144432991|SUPERIORITY_OR_OTHER||LS mean difference|-0.15||||0.517|TWO_SIDED|95.0|-0.611|0.308||From ANCOVA model with treatment and baseline Schiff stratification as factors and baseline VRS as covariate.|ANCOVA||From ANCOVA model with treatment and baseline Schiff stratification as factors and baseline VRS as covariate. Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|||0.308|-0.611|0.5170
72454895|NCT02542943|144432991|SUPERIORITY_OR_OTHER||LS mean difference|0.17||||0.4538|TWO_SIDED|95.0|-0.284|0.633||From ANCOVA model with treatment and baseline Schiff stratification as factors and baseline VRS as covariate.|ANCOVA||From ANCOVA model with treatment and baseline Schiff stratification as factors and baseline VRS as covariate. Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|||0.633|-0.284|0.4538
72454896|NCT02542943|144432991|SUPERIORITY_OR_OTHER||LS mean difference|-0.33||||0.1663|TWO_SIDED|95.0|-0.788|0.136||From ANCOVA model with treatment and baseline Schiff stratification as factors and baseline VRS as covariate.|ANCOVA||From ANCOVA model with treatment and baseline Schiff stratification as factors and baseline VRS as covariate. Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|||0.136|-0.788|0.1663
72454897|NCT02542943|144432992|SUPERIORITY_OR_OTHER||LS mean difference|-0.1||||0.7137|TWO_SIDED|95.0|-0.661|0.453||From ANCOVA model with treatment and baseline Schiff stratification as factors and baseline VRS as covariate.|ANCOVA||From ANCOVA model with treatment and baseline Schiff stratification as factors and baseline VRS as covariate. Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|||0.453|-0.661|0.7137
72499844|NCT01307423|144530055|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.53|||<|0.0001|TWO_SIDED|95.0|-0.74|-0.32|||ANCOVA||Based on analysis of covariance model for the change from baseline at Week 16, with treatment group as a factor and the baseline value as a covariate|||-0.32|-0.74|<0.0001
72499845|NCT01307423|144530056|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|1.12|||||TWO_SIDED|95.0|-0.63|2.87|||||Based on an analysis of covariance model for the change from baseline at Week 16, with treatment group as a factor and the baseline value as a covariate|||2.87|-0.63|
72499846|NCT01307423|144530056|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|2.55|||||TWO_SIDED|95.0|0.8|4.31|||||Based on an analysis of covariance model for the change from baseline at Week 16, with treatment group as a factor and the baseline value as a covariate|||4.31|0.80|
72499847|NCT01307423|144530057|SUPERIORITY_OR_OTHER_LEGACY||LS Means Difference|1.97|||||TWO_SIDED|95.0|0.28|3.65|||||Based on an analysis of covariance model for the change from baseline at Week 24, with treatment group as a factor and the baseline value as a covariate|||3.65|0.28|
72499848|NCT01307423|144530057|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|3.72|||||TWO_SIDED|95.0|2.02|5.41|||||Based on an analysis of covariance model for the change from baseline at Week 24, with treatment group as a factor and the baseline value as a covariate|||5.41|2.02|
72499849|NCT01307423|144530058|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|19.5|||||TWO_SIDED|95.0|10.5|28.6|||||Two-sided 95% CI of the proportion difference is based on the normal approximation to the binomial distribution|||28.6|10.5|
72499850|NCT01307423|144530058|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|18.2|||||TWO_SIDED|95.0|9.2|27.2|||||Two-sided 95% CI of the proportion difference is based on the normal approximation to the binomial distribution|||27.2|9.2|
72499851|NCT01307423|144530059|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-5.6|||||TWO_SIDED|95.0|-10.6|-0.5|||||Based on an analysis of covariance (Ancova) model for the change from baseline at Week 24, with treatment group as a factor and the baseline value as a covariate|||-0.5|-10.6|
72454898|NCT02542943|144432992|SUPERIORITY_OR_OTHER||LS mean difference|0.1||||0.7353|TWO_SIDED|95.0|-0.46|0.651||From ANCOVA model with treatment and baseline Schiff stratification as factors and baseline VRS as covariate.|ANCOVA||From ANCOVA model with treatment and baseline Schiff stratification as factors and baseline VRS as covariate. Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|||0.651|-0.460|0.7353
72454899|NCT02542943|144432992|SUPERIORITY_OR_OTHER||LS mean difference|-0.2||||0.4843|TWO_SIDED|95.0|-0.76|0.361||From ANCOVA model with treatment and baseline Schiff stratification as factors and baseline VRS as covariate.|ANCOVA||From ANCOVA model with treatment and baseline Schiff stratification as factors and baseline VRS as covariate. Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|||0.361|-0.760|0.4843
72454900|NCT01836445|144433014|SUPERIORITY||Prevalence Ratio|0.9||||0.2|TWO_SIDED|95.0|0.76|1.06|||Regression, Logistic|||||1.06|0.76|0.20
72454901|NCT01836445|144433015|SUPERIORITY||Prevalence Ratio|0.95||||0.6|TWO_SIDED|95.0|0.8|1.14|||Regression, Logistic|||||1.14|0.80|0.60
72454902|NCT01836445|144433016|SUPERIORITY||Prevalence Ratio|0.83||||0.04|TWO_SIDED|95.0|0.7|0.99|||Regression, Logistic|||||0.99|0.70|0.04
72499852|NCT01307423|144530059|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-5.7|||||TWO_SIDED|95.0|-10.8|-0.7|||||Based on an analysis of covariance (Ancova) model for the change from baseline at Week 24, with treatment group as a factor and the baseline value as a covariate|||-0.7|-10.8|
72499853|NCT01307423|144530060|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.3|||||TWO_SIDED|95.0|-1.0|0.4|||||Based on an analysis of covariance (Ancova) model for the change from baseline at Week 24, with treatment group as a factor and the baseline value as a covariate.|||0.4|-1.0|
72499854|NCT01307423|144530060|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.9|||||TWO_SIDED|95.0|-1.6|-0.2|||||Based on an analysis of covariance (Ancova) model for the change from baseline at Week 24, with treatment group as a factor and the baseline value as a covariate.|||-0.2|-1.6|
72499855|NCT01307423|144530061|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.0|||||TWO_SIDED|95.0|-1.7|-0.3|||||Based on an analysis of covariance (Ancova) model for the change from baseline at Week 24, with treatment group as a factor and the baseline value as a covariate.|||-0.3|-1.7|
72499856|NCT01307423|144530061|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.6|||||TWO_SIDED|95.0|-1.4|0.1|||||Based on an analysis of covariance (Ancova) model for the change from baseline at Week 24, with treatment group as a factor and the baseline value as a covariate.|||0.1|-1.4|
72454903|NCT01836445|144433018|SUPERIORITY||Risk Ratio (RR)|0.6||||0.01|TWO_SIDED|95.0|0.38|0.95|||Z-test|||||0.95|0.38|0.01
72499857|NCT01307423|144530062|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-5.07|||||TWO_SIDED|95.0|-7.31|-2.84|||||Based on an analysis of covariance (Ancova) model for the change from baseline at Week 24, with treatment group as a factor and the baseline value as a covariate.|||-2.84|-7.31|
72499858|NCT01307423|144530062|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-5.14|||||TWO_SIDED|95.0|-7.38|-2.89|||||Based on an analysis of covariance model (Ancova) for the change from baseline at Week 24, with treatment group as a factor and the baseline value as a covariate.|||-2.89|-7.38|
72499859|NCT01307423|144530063|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.47|||<|0.0001|TWO_SIDED|95.0|-0.7|-0.23|||ANCOVA||Based on an analysis of covariance (Ancova) model for the change from baseline at Week 24, with treatment group as a factor and the baseline value as a covariate.|||-0.23|-0.70|<0.0001
72454904|NCT01836445|144433019|OTHER|Generalized Linear Mixed Model statistical test used||||||0.15|||||||Regression, Linear|||||||0.150
72454905|NCT01836445|144433020|OTHER|Generalized Linear Mixed Model statistical test used||||||0.374|||||||Regression, Linear|||||||0.374
72454906|NCT01836445|144433021|OTHER|Generalized Linear Mixed Model statistical test used||||||0.919|||||||Regression, Linear|||Analysis for Motivation items||||0.919
72454907|NCT01836445|144433021|OTHER|Generalized Linear Mixed Model statistical test used||||||0.493|||||||Regression, Linear|||Analysis for Social Norms items||||0.493
72454908|NCT01836445|144433021|OTHER|Generalized Linear Mixed Model statistical test used||||||0.002|||||||Regression, Linear|||Analysis for Behavioral Skills items||||0.002
72454909|NCT01836445|144433022|OTHER|Generalized Linear Mixed Model statistical test used||||||0.067|||||||Regression, Linear|||Analysis for Relationship Maintenance items||||0.067
72454910|NCT01836445|144433022|OTHER|Generalized Linear Mixed Model statistical test used||||||0.135|||||||Regression, Linear|||Analysis for Condom Use items||||0.135
72454911|NCT01836445|144433022|OTHER|Generalized Linear Mixed Model statistical test used||||||0.025|||||||Regression, Linear|||Analysis for HIV Testing items||||0.025
72454912|NCT01836445|144433023|OTHER|Generalized Linear Mixed Model statistical test used||||||0.138|||||||Regression, Logistic|||||||0.138
72454913|NCT01836445|144433024|OTHER|Generalized Linear Mixed Model statistical test used||||||0.173|||||||Regression, Linear|||||||0.173
72454914|NCT01836445|144433025|OTHER|Generalized Linear Mixed Model statistical test used||||||0.567|||||||Regression, Linear|||||||0.567
72454915|NCT01836445|144433026|OTHER|Generalized Linear Mixed Model statistical test used||||||0.861|||||||Regression, Linear|||Analysis for motivation items||||0.861
72454916|NCT01836445|144433026|OTHER|Generalized Linear Mixed Model statistical test used||||||0.628|||||||Regression, Linear|||Analysis for social norms items||||0.628
72454917|NCT01836445|144433026|OTHER|Generalized Linear Mixed Model statistical test used||||||0.151|||||||Regression, Linear|||Analysis for behavioral skills items||||0.151
72499860|NCT01307423|144530063|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.46||||0.0001|TWO_SIDED|95.0|-0.69|-0.22|||ANCOVA||Based on an analysis of covariance model (Ancova) for the change from baseline at Week 24, with treatment group as a factor and the baseline value as a covariate.|||-0.22|-0.69|0.0001
72499861|NCT01307423|144530064|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|1.12|||||TWO_SIDED|95.0|-0.68|2.93|||||Based on an analysis of covariance model (Ancova) for the change from baseline at Week 24, with treatment group as a factor and the baseline value as a covariate.|||2.93|-0.68|
72499862|NCT01307423|144530064|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.33|||||TWO_SIDED|95.0|0.52|4.15|||||Based on an analysis of covariance model (Ancova) for the change from baseline at Week 24, with treatment group as a factor and the baseline value as a covariate.|||4.15|0.52|
72620416|NCT01694771|144772188|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.117|STANDARD_ERROR_OF_MEAN|0.014|<|0.0001|TWO_SIDED|95.0|0.09|0.144|||Mixed Model Repeated Measure|||Results are from an MMRM model. Fixed effects include treatment, visit, treatment by visit interaction, baseline and baseline by visit interaction. Patient is considered random and an unstructured covariance structure was used. Number of patients contributing to models: Tio+Placebo (564), Tio+Olo 5ug (563).||0.144|0.090|<0.0001
72620417|NCT01694771|144772189|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.062|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|0.037|0.088|||Mixed Model Repeated Measure|||Results are from an MMRM model. Fixed effects include treatment, visit, treatment by visit interaction, baseline and baseline by visit interaction. Patient is considered random and an unstructured covariance structure was used. Number of patients contributing to models: Tio+Placebo (551), Tio+Olo 5ug (548).||0.088|0.037|<0.0001
72620418|NCT01694771|144772190|SUPERIORITY_OR_OTHER||Mean change from baseline|0.119|STANDARD_ERROR_OF_MEAN|0.014|<|0.0001|TWO_SIDED|95.0|0.09|0.147|||Mixed model repeated measure|||Results are from an MMRM model. Fixed effects include treatment, visit, treatment by visit interaction, baseline and baseline by visit interaction. Patient is considered random and an unstructured covariance structure was used. Number of patients contributing to models: Tio+Placebo (564), Tio+Olo 5ug (563).||0.147|0.090|<0.0001
72620419|NCT01694771|144772191|SUPERIORITY_OR_OTHER||Mean difference from Tio + Placebo|0.146|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001|TWO_SIDED|95.0|0.1|0.192|||Mixed model repeated measure|||Results are from an MMRM model. Fixed effects include treatment, visit, treatment by visit interaction, baseline and baseline by visit interaction. Patient is considered random and an unstructured covariance structure was used. Number of patients contributing to models: Tio+Placebo (564), Tio+Olo 5ug (563).||0.192|0.100|<0.0001
72620420|NCT01694771|144772192|SUPERIORITY_OR_OTHER||Mean difference from Tio + Placebo|0.063|STANDARD_ERROR_OF_MEAN|0.022||0.0047|TWO_SIDED|95.0|0.019|0.106|||Mixed model repeated measure|||Results are from an MMRM model. Fixed effects include treatment, visit, treatment by visit interaction, baseline and baseline by visit interaction. Patient is considered random and an unstructured covariance structure was used. Number of patients contributing to models: Tio+Placebo (551), Tio+Olo 5ug (548).||0.106|0.019|0.0047
72620421|NCT01694771|144772193|SUPERIORITY_OR_OTHER||Mean difference from Tio + Placebo|0.153|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001|TWO_SIDED|95.0|0.106|0.201|||Mixed model repeated measure|||Results are from an MMRM model. Fixed effects include treatment, visit, treatment by visit interaction, baseline and baseline by visit interaction. Patient is considered random and an unstructured covariance structure was used. Number of patients contributing to models: Tio+Placebo (564), Tio+Olo 5ug (563).||0.201|0.106|<0.0001
72620422|NCT01694771|144772194|SUPERIORITY_OR_OTHER||Mean difference from Tio+Placebo Week 12|8.459|STANDARD_ERROR_OF_MEAN|2.192||0.0001|TWO_SIDED|95.0|4.159|12.759|||ANCOVA|||"Week 12: Results are from non-MMRM ANCOVA models by week with LOCF up to each week. Fixed effects include treatment and baseline.~Number of patients contributing to models: Tio+Placebo (561), Tio+Olo 5ug (557)."||12.759|4.159|0.0001
72454918|NCT01836445|144433027|OTHER|Generalized Linear Mixed Model statistical test used||||||0.001|||||||Regression, Linear|||Analysis for Relationship Maintenance items||||0.001
72454919|NCT01836445|144433027|OTHER|Generalized Linear Mixed Model statistical test used||||||0.067|||||||Regression, Linear|||Analysis for Condom Use items||||0.067
72454920|NCT01836445|144433027|OTHER|Generalized Linear Mixed Model statistical test used||||||0.637|||||||Regression, Linear|||Analysis for HIV Testing items||||0.637
72454921|NCT01836445|144433028|OTHER|Generalized Linear Mixed Model statistical test used||||||0.862|||||||Regression, Linear|||||||0.862
72454922|NCT01836445|144433029|OTHER|Generalized Linear Mixed Model statistical test used||||||0.762|||||||Regression, Linear|||||||0.762
72454923|NCT01836445|144433030|SUPERIORITY|||||||0.043|||||||Regression, Linear|||Analysis for Motivation items||||0.043
72454924|NCT01836445|144433030|SUPERIORITY|||||||0.617|||||||Regression, Linear|||Analysis for Social Norm items||||0.617
72454925|NCT01836445|144433030|SUPERIORITY|||||||0.57|||||||Regression, Linear|||Analysis for Behavioral Skills items||||0.570
72454926|NCT01836445|144433031|SUPERIORITY|||||||0.036|||||||Regression, Linear|||Analysis for Relationship Maintenance items||||0.036
72454927|NCT01836445|144433031|SUPERIORITY|||||||0.837|||||||Regression, Linear|||Analysis for Condom Use items||||0.837
72454928|NCT01836445|144433031|SUPERIORITY|||||||0.953|||||||Regression, Linear|||Analysis for HIV Testing items||||0.953
72454929|NCT01836445|144433032|SUPERIORITY|||||||0.719|||||||Regression, Linear|||||||0.719
72454930|NCT04278833|144433052|OTHER||||||<|0.001||||||The a priori threshold for statistical significance was \<0.05.|paired t-tests|||Analysis of change at week 2||||<0.001
72454931|NCT04278833|144433052|OTHER||||||<|0.001||||||The a priori threshold for statistical significance was \<0.05.|paired t-tests|||Analysis of change at month 3||||<0.001
72454932|NCT04278833|144433052|OTHER||||||<|0.001||||||The a priori threshold for statistical significance was \<0.05.|paired t-tests|||Analysis of change at month 6||||<0.001
72454933|NCT04278833|144433053|OTHER|||||||0.28||||||The a priori threshold for statistical significance was \<0.05.|Chi-squared|||Analysis of change at week 2||||0.280
72454934|NCT04278833|144433053|OTHER|||||||0.07||||||The a priori threshold for statistical significance was \<0.05.|Chi-squared|||Analysis of change at month 3||||0.070
72454935|NCT04278833|144433053|OTHER|||||||0.851||||||The a priori threshold for statistical significance was \<0.05.|Chi-squared|||Analysis of change at month 6||||0.851
72454936|NCT04278833|144433054|OTHER||||||<|0.001||||||The a priori threshold for statistical significance was \<0.05.|paired t-tests|||Analysis of change at week 2||||<0.001
72454937|NCT04278833|144433054|OTHER|||||||0.021||||||The a priori threshold for statistical significance was \<0.05.|paired t-tests|||Analysis of change at month 3||||0.021
72454938|NCT04278833|144433054|OTHER|||||||0.044||||||The a priori threshold for statistical significance was \<0.05.|paired t-tests|||Analysis of change at month 6||||0.044
72454939|NCT04278833|144433055|OTHER|||||||0.226||||||The a priori threshold for statistical significance was \<0.05.|paired t-tests|||Analysis of change at week 2||||0.226
72454940|NCT04278833|144433055|OTHER|||||||0.071||||||The a priori threshold for statistical significance was \<0.05.|paired t-tests|||Analysis of change at month 3||||0.071
72454941|NCT04278833|144433055|OTHER|||||||0.382||||||The a priori threshold for statistical significance was \<0.05.|paired t-tests|||Analysis of change at month 6||||0.382
72499863|NCT01307423|144530065|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|2.6|||||TWO_SIDED|95.0|-10.2|15.5|||||Two-sided 95% CI of the proportion difference is based on the normal approximation to the binomial distribution|||15.5|-10.2|
72499864|NCT01307423|144530065|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|17.0|||||TWO_SIDED|95.0|4.2|29.8|||||Two-sided 95% CI of the proportion difference is based on the normal approximation to the binomial distribution|||29.8|4.2|
72499865|NCT01307423|144530066|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|6.3|||||TWO_SIDED|95.0|-7.8|20.4|||||Two-sided 95% CI of the proportion difference is based on the normal approximation to the binomial distribution.|||20.4|-7.8|
72499866|NCT01307423|144530066|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|1.9|||||TWO_SIDED|95.0|-12.6|16.4|||||Two-sided 95% CI of the proportion difference is based on the normal approximation to the binomial distribution.|||16.4|-12.6|
72499867|NCT01307423|144530067|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|16.1|||||TWO_SIDED|95.0|6.4|25.8|||||Two-sided 95% CI of the proportion difference is based on the normal approximation to the binomial distribution.|||25.8|6.4|
72499868|NCT01307423|144530067|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|19.3|||||TWO_SIDED|95.0|9.6|29.1|||||Two-sided 95% CI of the proportion difference is based on the normal approximation to the binomial distribution.|||29.1|9.6|
72499869|NCT01307423|144530068|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|6.0|||||TWO_SIDED|95.0|-6.8|18.8|||||Two-sided 95% CI of the proportion difference is based on the normal approximation to the binomial distribution|||18.8|-6.8|
72562726|NCT01396421|144657270|SUPERIORITY_OR_OTHER||Treatment difference|-1.1||||0.0246|TWO_SIDED|95.0|-2.06|-0.14||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|||||-0.14|-2.06|0.0246
72562727|NCT01396421|144657270|SUPERIORITY_OR_OTHER||Treatment difference|-1.22||||0.0131|TWO_SIDED|95.0|-2.19|-0.26||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|||||-0.26|-2.19|0.0131
72562728|NCT01396421|144657270|SUPERIORITY_OR_OTHER||Treatment difference|-0.34||||0.5706|TWO_SIDED|95.0|-1.53|0.85||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|||||0.85|-1.53|0.5706
72562729|NCT01396421|144657271|SUPERIORITY_OR_OTHER||Relative risk|0.39||||0.0143|TWO_SIDED|95.0|0.18|0.85|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial center was applied to the analysis of discontinuation rate.||||0.85|0.18|0.0143
72562730|NCT01396421|144657271|SUPERIORITY_OR_OTHER||Relative risk|0.87||||0.6606|TWO_SIDED|95.0|0.46|1.65||CMH general association test controlling for trial center was applied to the analysis of discontinuation rate.|Cochran-Mantel-Haenszel|||||1.65|0.46|0.6606
72562731|NCT01396421|144657271|SUPERIORITY_OR_OTHER||Relative risk|0.77||||0.5115|TWO_SIDED|95.0|0.35|1.68||CMH general association test controlling for trial center was applied to the analysis of discontinuation rate.|Cochran-Mantel-Haenszel|||||1.68|0.35|0.5115
72562732|NCT01396421|144657272|SUPERIORITY_OR_OTHER||Treatment difference|-2.34||||0.0014|TWO_SIDED|95.0|-3.77|-0.91||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|||||-0.91|-3.77|0.0014
72562733|NCT01396421|144657272|SUPERIORITY_OR_OTHER||Treatment difference|-2.47||||0.0008|TWO_SIDED|95.0|-3.91|-1.04||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|||||-1.04|-3.91|0.0008
72562734|NCT01396421|144657272|SUPERIORITY_OR_OTHER||Treatment difference|-0.89||||0.3263|TWO_SIDED|95.0|-2.66|0.89||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates|Mixed Models Analysis|||||0.89|-2.66|0.3263
72562735|NCT01396421|144657273|SUPERIORITY_OR_OTHER||Treatment difference|-1.3||||0.0155|TWO_SIDED|95.0|-2.35|-0.25||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|||||-0.25|-2.35|0.0155
72562736|NCT01396421|144657273|SUPERIORITY_OR_OTHER||Treatment difference|-1.68||||0.0019|TWO_SIDED|95.0|-2.73|-0.62||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|||||-0.62|-2.73|0.0019
72562737|NCT01396421|144657273|SUPERIORITY_OR_OTHER||Treatment difference|-0.86||||0.1956|TWO_SIDED|95.0|-2.17|0.44||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|||||0.44|-2.17|0.1956
72562738|NCT01396421|144657274|SUPERIORITY_OR_OTHER||Treatment difference|-1.75||||0.0007|TWO_SIDED|95.0|-2.76|-0.75||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|||||-0.75|-2.76|0.0007
72562739|NCT01396421|144657274|SUPERIORITY_OR_OTHER||Treatment difference|-1.98||||0.0001|TWO_SIDED|95.0|-2.98|-0.97||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|||||-0.97|-2.98|0.0001
72562740|NCT01396421|144657274|SUPERIORITY_OR_OTHER||Treatment difference|-0.72||||0.2572|TWO_SIDED|95.0|-1.96|0.52||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|||||0.52|-1.96|0.2572
72499870|NCT01307423|144530068|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|18.0|||||TWO_SIDED|95.0|5.3|30.6|||||Two-sided 95% CI of the proportion difference is based on the normal approximation to the binomial distribution|||30.6|5.3|
72499871|NCT01307423|144530069|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|11.9|||||TWO_SIDED|95.0|-2.1|25.9|||||Two-sided 95% CI of the proportion difference is based on the normal approximation to the binomial distribution.|||25.9|-2.1|
72499872|NCT01307423|144530069|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|5.3|||||TWO_SIDED|95.0|-9.2|19.8|||||Two-sided 95% CI of the proportion difference is based on the normal approximation to the binomial distribution.|||19.8|-9.2|
72499873|NCT01307423|144530070|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|17.8|||||TWO_SIDED|95.0|8.8|26.8|||||Two-sided 95% CI of the proportion difference is based on the normal approximation to the binomial distribution.|||26.8|8.8|
72454942|NCT04278833|144433056|OTHER|||||||0.152||||||The a priori threshold for statistical significance was \<0.05.|paired t-tests|||Analysis of change at week 2||||0.152
72454943|NCT04278833|144433056|OTHER|||||||0.261||||||The a priori threshold for statistical significance was \<0.05.|paired t-tests|||Analysis of change at month 3.||||0.261
72454944|NCT04278833|144433056|OTHER|||||||0.437||||||The a priori threshold for statistical significance was \<0.05.|paired t-tests|||Analysis of change at month 6.||||0.437
72454945|NCT04278833|144433057|OTHER|||||||0.128||||||The a priori threshold for statistical significance was \<0.05.|Fisher Exact|||||||0.128
72454946|NCT04278833|144433057|OTHER||||||>|0.999||||||The a priori threshold for statistical significance was \<0.05.|Fisher Exact|||||||>0.999
72454947|NCT04278833|144433058|OTHER|||||||0.04||||||The a priori threshold for statistical significance was \<0.05.|Fisher Exact|||||||0.040
72454948|NCT04278833|144433058|OTHER||||||>|0.999||||||The a priori threshold for statistical significance was \<0.05.|Fisher Exact|||||||>0.999
72454949|NCT02294461|144433135|SUPERIORITY_OR_OTHER_LEGACY||Unstratified Cox Proportional Hazards|0.38|||<|0.0001|TWO_SIDED|95.0|0.27|0.52|||Hazard Ratio|||P-value is based on an unstratified log-rank test. Hazard ratio calculated using unstratified Cox Proportional Hazards model with treatment as the only covariate for enzalutamide group versus placebo group.||0.52|0.27|<0.0001
72454950|NCT02294461|144433136|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.7||||0.0208|TWO_SIDED|95.0|0.51|0.95||P-value is based on an unstratified log-rank test.|Unstratified log-rank test|||Participants who were not known to have had died at the analysis date were censored at date last known alive. Hazard ratio calculated using unstratified Cox Proportional Hazards model with treatment as the only covariate for enzalutamide group versus placebo group.||0.95|0.51|0.0208
72454951|NCT02294461|144433137|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.31|||<|0.0001||95.0|0.2|0.46||P-value is based on an unstratified log-rank test.|Unstratified log-rank test|||Participants who were not known to have had an rPFS event were censored at the date of the last assessment showing no objective evidence of rPFS prior to scan modality change, new antineoplastic treatment, initiation of radiation therapy for prostate cancer, skeletal-related event (SRE) and 2 or more consecutive missed tumor assessments. Hazard ratio calculated using unstratified Cox Proportional Hazards model with treatment as the only covariate for enzalutamide.||0.46|0.20|<0.0001
72454952|NCT02294461|144433138|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.56||||0.2501|TWO_SIDED|95.0|0.21|1.52||P-value was based on an unstratified log-rank test.|Unstratified log-rank test|||Participants who did not have an SRE were censored at the date of the last assessment indicating no evidence of SRE. Hazard ratio calculated using unstratified Cox Proportional Hazards model with treatment as the only covariate for enzalutamide group versus placebo group.||1.52|0.21|0.2501
72454953|NCT02294461|144433139|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.28||||0.002||95.0|0.12|0.66||P-value is based on an unstratified log-rank test.|Unstratified log-rank test|||Participants who did not start cytotoxic chemotherapy were censored at the date of the last assessment indicating no evidence of cytotoxic chemotherapy usage. Hazard ratio calculated using unstratified Cox Proportional Hazards model with treatment as the only covariate for enzalutamide group versus placebo group.||0.66|0.12|0.0020
72454954|NCT02294461|144433140|SUPERIORITY_OR_OTHER_LEGACY||Difference of response rate|55.8|||<|0.0001|TWO_SIDED|95.0|47.4|64.2||P-value is based on unstratified Cochran-Mantel-Haenszel mean score test.|Unstratified Cochran-Mantel-Haenszel %|||||64.2|47.4|<0.0001
72454955|NCT02294461|144433141|SUPERIORITY_OR_OTHER_LEGACY||Difference in objective response rate|26.0|||<|0.0001|TWO_SIDED|95.0|14.7|37.4||P-value is based on unstratified Cochran-Mantel-Haenszel mean score test.|Unstratified Cochran-Mantel-Haenszel|||When deriving the response category, it was based on the target, non-target and new lesions without confirming CR, PR, and Progressive disease (PD). Participants with no post baseline assessment were included in the category of Nonevaluable (NE). The best overall soft tissue objective response was defined as PR or CR based on the investigator assessments of target, non-target and new lesions while on the study treatment.||37.4|14.7|<0.0001
72454956|NCT00887224|144433176|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Significance declared if p-value ≤0.05. The estimated probability obtained via Kaplan-Meier estimate.|Log Rank|||||||<0.001
72454957|NCT00887224|144433178|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.9627|TWO_SIDED|95.0|-0.09|0.08||"P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment\*visit with Unstructured covariance structure."|Mixed Models Analysis|Mixed-effects model for repeated measures (MMRM).||Adjusted difference from placebo: Week 1||0.08|-0.09|0.9627
72454958|NCT00887224|144433178|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.09||||0.1046|TWO_SIDED|95.0|-0.02|0.21||"P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment\*visit with Unstructured covariance structure."|Mixed Models Analysis|Mixed-effects model for repeated measures (MMRM).||Adjusted difference from placebo: Week 2||0.21|-0.02|0.1046
72499874|NCT01307423|144530070|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|11.4|||||TWO_SIDED|95.0|2.7|20.0|||||Two-sided 95% CI of the proportion difference is based on the normal approximation to the binomial distribution.|||20.0|2.7|
72499875|NCT01307423|144530071|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|6.9|||||TWO_SIDED|95.0|1.3|12.5|||||Two-sided 95% CI of the proportion difference is based on the normal approximation to the binomial distribution.|||12.5|1.3|
72562741|NCT01396421|144657275|SUPERIORITY_OR_OTHER||Treatment difference|-1.07||||0.0085|TWO_SIDED|95.0|-1.87|-0.28||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|||||-0.28|-1.87|0.0085
72454959|NCT00887224|144433178|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.13||||0.0228|TWO_SIDED|95.0|0.02|0.25||"P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment\*visit with Unstructured covariance structure."|Mixed Models Analysis|Mixed-effects model for repeated measures (MMRM).||Adjusted difference from placebo: Week 3||0.25|0.02|0.0228
72454960|NCT00887224|144433178|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.17||||0.0064|TWO_SIDED|95.0|0.05|0.29||"P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment\*visit with Unstructured covariance structure."|Mixed Models Analysis|Mixed-effects model for repeated measures (MMRM).||Adjusted difference from placebo: Week 4||0.29|0.05|0.0064
72499876|NCT01307423|144530071|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|6.8|||||TWO_SIDED|95.0|1.2|12.4|||||Two-sided 95% CI of the proportion difference is based on the normal approximation to the binomial distribution.|||12.4|1.2|
72454961|NCT00887224|144433178|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.25|||<|0.001|TWO_SIDED|95.0|0.11|0.39||"P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment\*visit with Unstructured covariance structure."|Mixed Models Analysis|Mixed-effects model for repeated measures (MMRM).||Adjusted difference from placebo: Week 6||0.39|0.11|<0.001
72499877|NCT01307423|144530072|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|2.9|||||TWO_SIDED|95.0|-0.4|6.2|||||Two-sided 95% CI of the proportion difference is based on the normal approximation to the binomial distribution|||6.2|-0.4|
72499878|NCT01307423|144530072|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|2.8|||||TWO_SIDED|95.0|-0.4|6.1|||||Two-sided 95% CI of the proportion difference is based on the normal approximation to the binomial distribution|||6.1|-0.4|
72562742|NCT01396421|144657275|SUPERIORITY_OR_OTHER||Treatment difference|-1.08||||0.0081|TWO_SIDED|95.0|-1.88|-0.28||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|||||-0.28|-1.88|0.0081
72562743|NCT01396421|144657275|SUPERIORITY_OR_OTHER||Treatment difference|-0.33||||0.5172|TWO_SIDED|95.0|-1.31|0.66||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|||||0.66|-1.31|0.5172
72562744|NCT01396421|144657276|SUPERIORITY_OR_OTHER||Treatment difference|-0.34||||0.3284|TWO_SIDED|95.0|-1.03|0.35||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|||||0.35|-1.03|0.3284
72562745|NCT01396421|144657276|SUPERIORITY_OR_OTHER||Treatment difference|-0.65||||0.0655|TWO_SIDED|95.0|-1.34|0.04||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|||||0.04|-1.34|0.0655
72562746|NCT01396421|144657276|SUPERIORITY_OR_OTHER||Treatment difference|-0.21||||0.6251|TWO_SIDED|95.0|-1.07|0.64||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|||||0.64|-1.07|0.6251
72562747|NCT04718129|144657277|SUPERIORITY||Mean Difference (Net)|0.044|STANDARD_ERROR_OF_MEAN|0.021||0.048|TWO_SIDED|95.0|0.003|0.085|||Regression, Linear|||||.085|.003|.048
72562748|NCT02030535|144657282|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.219|STANDARD_ERROR_OF_MEAN|0.016|<|0.0001|TWO_SIDED|95.0|0.187|0.252||Mixed effect model repeated measures (MMRM) including fixed effects of treatment and period; patient baseline and period baseline as covariates; patient as a random effect|Mixed models repeated measures analysis|Kenward-Roger approximation of denominator degrees of freedom. Compound symmetry covariance structure for within-patient variation|Tio+Olo 5/5μg minus Placebo.|||0.252|0.187|<0.0001
72562749|NCT02030535|144657282|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.252|STANDARD_ERROR_OF_MEAN|0.016|<|0.0001|TWO_SIDED|95.0|0.22|0.284||Mixed effect model repeated measures (MMRM) including fixed effects of treatment and period; patient baseline and period baseline as covariates; patient as a random effect|Mixed models repeated measures analysis|Kenward-Roger approximation of denominator degrees of freedom. Compound symmetry covariance structure for within-patient variation.|Tiotropium 5μg + Olodaterol 5μg minus Placebo.|||0.284|0.220|<0.0001
72562750|NCT02030535|144657282|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.033|STANDARD_ERROR_OF_MEAN|0.016|||TWO_SIDED|95.0|-0.065|-0.001|||||Tio+Olo 5/5μg minus Tiotropium 5μg + Olodaterol 5μg.|Descriptive comparison. Statistical Analyses 1 \& 2 were included in the hierarchical testing sequence (alpha protected), and analysis 3 was not included in the hierarchical testing sequence (not alpha protected)||-0.001|-0.065|
72562751|NCT01835548|144657300|SUPERIORITY||Least Square Mean Difference|-11.04|STANDARD_ERROR_OF_MEAN|1.4239|<|0.0001|TWO_SIDED|95.0|-13.9|-8.2|||ANCOVA|||||-8.20|-13.9|<0.0001
72454962|NCT00887224|144433178|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.28|||<|0.001|TWO_SIDED|95.0|0.12|0.43||"P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment\*visit with Unstructured covariance structure."|Mixed Models Analysis|Mixed-effects model for repeated measures (MMRM).||Adjusted difference from placebo: Week 10||0.43|0.12|<0.001
72499879|NCT01307423|144530073|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|9.8|||||TWO_SIDED|95.0|3.2|16.3|||||Two-sided 95% CI of the proportion difference is based on the normal approximation to the binomial distribution|||16.3|3.2|
72562752|NCT00991510|144657331|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was accepted if the calculated 90 % CIs were within 0.80-1.25.|adjusted least-squares mean ratio|0.923|||||TWO_SIDED|90.0|0.865|0.984|||ANOVA|||A total of 100 subjects were planned to be enrolled, allowing for 10% drop-out rate. Based on previous single dose studies, the intra-subject coefficients of variation were 14% and 50% for AUC and Cmax, respectively. Based on the literature similar intra subject coefficients of variation were observed in steady-state patients. With these expected CV(%) and an expected ratio of Cmax within 0.95 and 1.05, the study should have a power of at least 80 % to show bioequivalence with 80 subjects.||0.984|0.865|
72499880|NCT01307423|144530073|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|6.3|||||TWO_SIDED|95.0|0.2|12.3|||||Two-sided 95% CI of the proportion difference is based on the normal approximation to the binomial distribution|||12.3|0.2|
72499881|NCT01307423|144530074|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|0.0|||||TWO_SIDED|95.0|-4.1|4.1|||||Two-sided 95% CI of the proportion difference is based on the normal approximation to the binomial distribution.|||4.1|-4.1|
72499882|NCT01307423|144530074|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|0.6|||||TWO_SIDED|95.0|-3.7|4.8|||||Two-sided 95% CI of the proportion difference is based on the normal approximation to the binomial distribution.|||4.8|-3.7|
72499883|NCT01307423|144530075|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|2.2|||||TWO_SIDED|95.0|-8.1|12.6|||||Two-sided 95% CI of the proportion difference is based on the normal approximation to the binomial distribution.|||12.6|-8.1|
72562753|NCT00991510|144657332|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was accepted if the calculated 90 % CIs were within 0.80-1.25.|adjusted least-squares mean ratio|0.959|||||TWO_SIDED|90.0|0.899|1.023|||ANOVA|||||1.023|0.899|
72562754|NCT00991510|144657333|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was accepted if the calculated 90 % CIs were within 0.80-1.25.|adjusted least-squares mean ratio|0.873|||||TWO_SIDED|90.0|0.787|0.968|||ANOVA|||||0.968|0.787|
72562755|NCT00991510|144657334|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was accepted if the calculated 90 % CIs were within 0.80-1.25.|adjusted least-squares mean ratio|0.985|||||TWO_SIDED|90.0|0.877|1.106|||ANOVA|||||1.106|0.877|
72454963|NCT00887224|144433178|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.33|||<|0.001|TWO_SIDED|95.0|0.19|0.47||"P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment\*visit with Unstructured covariance structure."|Mixed Models Analysis|Mixed-effects model for repeated measures (MMRM).||Adjusted difference from placebo: Week 14||0.47|0.19|<0.001
72454964|NCT00887224|144433178|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.33|||<|0.001|TWO_SIDED|95.0|0.17|0.49||"P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment\*visit with Unstructured covariance structure."|Mixed Models Analysis|Mixed-effects model for repeated measures (MMRM).||Adjusted difference from placebo: Week 18||0.49|0.17|<0.001
72454965|NCT00887224|144433178|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.43|||<|0.001|TWO_SIDED|95.0|0.25|0.62||"P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment\*visit with Unstructured covariance structure."|Mixed Models Analysis|Mixed-effects model for repeated measures (MMRM).||Adjusted difference from placebo: Week 22||0.62|0.25|<0.001
72454966|NCT00887224|144433178|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.44|||<|0.001|TWO_SIDED|95.0|0.28|0.61||"P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment\*visit with Unstructured covariance structure."|Mixed Models Analysis|Mixed-effects model for repeated measures (MMRM).||Adjusted difference from placebo: Week 26||0.61|0.28|<0.001
72454967|NCT00887224|144433179|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.03||||0.8853|TWO_SIDED|95.0|-0.41|0.47||"P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment\*visit with Unstructured covariance structure."|Mixed Models Analysis|Mixed-effects model for repeated measures (MMRM).||Adjusted difference from placebo: Week 1||0.47|-0.41|0.8853
72454968|NCT00887224|144433179|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.88||||0.0081|TWO_SIDED|95.0|0.23|1.52||"P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment\*visit with Unstructured covariance structure."|Mixed Models Analysis|Mixed-effects model for repeated measures (MMRM).||Adjusted difference from placebo: Week 2||1.52|0.23|0.0081
72454969|NCT00887224|144433179|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.88||||0.0038|TWO_SIDED|95.0|0.28|1.47||"P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment\*visit with Unstructured covariance structure."|Mixed Models Analysis|Mixed-effects model for repeated measures (MMRM).||Adjusted difference from placebo: Week 3||1.47|0.28|0.0038
72454970|NCT00887224|144433179|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.39|||<|0.001|TWO_SIDED|95.0|0.76|2.03||"P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment\*visit with Unstructured covariance structure."|Mixed Models Analysis|Mixed-effects model for repeated measures (MMRM).||Adjusted difference from placebo: Week 4||2.03|0.76|<0.001
72454971|NCT00887224|144433179|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.63|||<|0.001|TWO_SIDED|95.0|0.86|2.39||"P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment\*visit with Unstructured covariance structure."|Mixed Models Analysis|Mixed-effects model for repeated measures (MMRM).||Adjusted difference from placebo: Week 6||2.39|0.86|<0.001
72454972|NCT00887224|144433179|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.68|||<|0.001|TWO_SIDED|95.0|0.83|2.54||"P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment\*visit with Unstructured covariance structure."|Mixed Models Analysis|Mixed-effects model for repeated measures (MMRM).||Adjusted difference from placebo: Week 10||2.54|0.83|<0.001
72454973|NCT00887224|144433179|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.04|||<|0.001|TWO_SIDED|95.0|1.23|2.86||"P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment\*visit with Unstructured covariance structure."|Mixed Models Analysis|Mixed-effects model for repeated measures (MMRM).||Adjusted difference from placebo: Week 14||2.86|1.23|<0.001
72454974|NCT00887224|144433179|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.95|||<|0.001|TWO_SIDED|95.0|1.06|2.84||"P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment\*visit with Unstructured covariance structure."|Mixed Models Analysis|Mixed-effects model for repeated measures (MMRM).||Adjusted difference from placebo: Week 18||2.84|1.06|<0.001
72454975|NCT00887224|144433179|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.3|||<|0.001|TWO_SIDED|95.0|1.31|3.3||"P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment\*visit with Unstructured covariance structure."|Mixed Models Analysis|Mixed-effects model for repeated measures (MMRM).||Adjusted difference from placebo: Week 22||3.30|1.31|<0.001
72454976|NCT00887224|144433179|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.35|||<|0.001|TWO_SIDED|95.0|1.39|3.32||"P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment\*visit with Unstructured covariance structure."|Mixed Models Analysis|Mixed-effects model for repeated measures (MMRM).||Adjusted difference from placebo: Week 26||3.32|1.39|<0.001
72454977|NCT00887224|144433180|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01||||0.9142|TWO_SIDED|95.0|-0.24|0.27||"P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment\*visit with Unstructured covariance structure."|Mixed Models Analysis|Mixed-effects model for repeated measures (MMRM).||Adjusted difference from placebo: Week 1||0.27|-0.24|0.9142
72454978|NCT00887224|144433180|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.53||||0.0069|TWO_SIDED|95.0|0.15|0.91||"P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment\*visit with Unstructured covariance structure."|Mixed Models Analysis|Mixed-effects model for repeated measures (MMRM).||Adjusted difference from placebo: Week 2||0.91|0.15|0.0069
72454979|NCT00887224|144433180|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.58||||0.0023|TWO_SIDED|95.0|0.21|0.95||"P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment\*visit with Unstructured covariance structure."|Mixed Models Analysis|Mixed-effects model for repeated measures (MMRM).||Adjusted difference from placebo: Week 3||0.95|0.21|0.0023
72454980|NCT00887224|144433180|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.89|||<|0.001|TWO_SIDED|95.0|0.49|1.28||"P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment\*visit with Unstructured covariance structure."|Mixed Models Analysis|Mixed-effects model for repeated measures (MMRM).||Adjusted difference from placebo: Week 4||1.28|0.49|<0.001
72454981|NCT00887224|144433180|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.88|||<|0.001|TWO_SIDED|95.0|0.43|1.32||"P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment\*visit with Unstructured covariance structure."|Mixed Models Analysis|Mixed-effects model for repeated measures (MMRM).||Adjusted difference from placebo: Week 6||1.32|0.43|<0.001
72454982|NCT00887224|144433180|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.08|||<|0.001|TWO_SIDED|95.0|0.58|1.58||"P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment\*visit with Unstructured covariance structure."|Mixed Models Analysis|Mixed-effects model for repeated measures (MMRM).||Adjusted difference from placebo: Week 10||1.58|0.58|<0.001
72454983|NCT00887224|144433180|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.12|||<|0.001|TWO_SIDED|95.0|0.66|1.58||"P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment\*visit with Unstructured covariance structure."|Mixed Models Analysis|Mixed-effects model for repeated measures (MMRM).||Adjusted difference from placebo: Week 14||1.58|0.66|<0.001
72454984|NCT00887224|144433180|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.3|||<|0.001|TWO_SIDED|95.0|0.76|1.83||"P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment\*visit with Unstructured covariance structure."|Mixed Models Analysis|Mixed-effects model for repeated measures (MMRM).||Adjusted difference from placebo: Week 18||1.83|0.76|<0.001
72454985|NCT00887224|144433180|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.23|||<|0.001|TWO_SIDED|95.0|0.7|1.76||"P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment\*visit with Unstructured covariance structure."|Mixed Models Analysis|Mixed-effects model for repeated measures (MMRM).||Adjusted difference from placebo: Week 22||1.76|0.70|<0.001
72454986|NCT00887224|144433180|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.27|||<|0.001|TWO_SIDED|95.0|0.75|1.79||"P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment\*visit with Unstructured covariance structure."|Mixed Models Analysis|Mixed-effects model for repeated measures (MMRM).||Adjusted difference from placebo: Week 26||1.79|0.75|<0.001
72454987|NCT00887224|144433181|SUPERIORITY_OR_OTHER||Adjusted odds ratio|2.85|||<|0.0001|TWO_SIDED|95.0|1.93|4.2||Obtained from logistic regression analysis using Remission (Yes/No) at each time point as a response variable; logistic model with treatment and sites as factors and baseline HAM-D17 total score as covariate.|Regression, Logistic|||Wald 95% CI for adjusted odds ratio.||4.20|1.93|<0.0001
72454988|NCT00887224|144433182|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.14|||<|0.001|TWO_SIDED|95.0|-3.03|-1.24||"P-value obtained from mixed model: change from baseline = baseline + treatment + visit + treatment\*visit with Unstructured covariance structure."|Mixed Models Analysis|Mixed-effects model for repeated measures (MMRM).||Adjusted difference from placebo: Week 14||-1.24|-3.03|<0.001
72499884|NCT01307423|144530075|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|17.8|||||TWO_SIDED|95.0|6.3|29.3|||||Two-sided 95% CI of the proportion difference is based on the normal approximation to the binomial distribution.|||29.3|6.3|
72499885|NCT01307423|144530076|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|9.4|||||TWO_SIDED|95.0|-4.8|23.5|||||Two-sided 95% CI of the proportion difference is based on the normal approximation to the binomial distribution.|||23.5|-4.8|
72454989|NCT00887224|144433182|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.32|||<|0.001|TWO_SIDED|95.0|-3.29|-1.34||"P-value obtained from mixed model: change from baseline = baseline + treatment + visit + treatment\*visit with Unstructured covariance structure."|Mixed Models Analysis|Mixed-effects model for repeated measures (MMRM).||Adjusted difference from placebo: Week 26||-1.34|-3.29|<0.001
72454990|NCT00887224|144433183|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.02||||0.6772|TWO_SIDED|95.0|-3.82|5.87||"P-value obtained from mixed model: change from baseline = baseline + treatment + visit + treatment\*visit with Unstructured covariance structure."|Mixed Models Analysis|Mixed-effects model for repeated measures (MMRM).||Adjusted difference from placebo: Week 14 Absenteeism||5.87|-3.82|0.6772
72562756|NCT01976728|144657340|SUPERIORITY|The hypotheses were tested using a stratified one-sided Fisher's exact test in the FAS including the randomization scheme as the stratification factor.||||||0.012||||||The SAS PROC FREQ with permutation-based Cochran-Mantel-Haenszel test with exact p-value derived from all possible permutations was employed for the calculation of p-value for the stratified Fisher's exact test.|Fisher Exact|The success threshold at each analysis corresponded to a nominal p-value \<0.0130 to maintain an overall one-sided type I error rate of 0.025.||The primary efficacy analysis compared the pooled ovulation rate of the LutrePulse 15 μg and 20 μg group to placebo.||||0.0120
72562757|NCT01976728|144657341|SUPERIORITY|The hypotheses were tested using a stratified one-sided Fisher's exact test in the FAS including the randomization scheme as the stratification factor.||||||0.0553||||||The SAS PROC FREQ with permutation-based Cochran-Mantel-Haenszel test with exact p-value derived from all possible permutations was employed for the calculation of p-value for the stratified Fisher's exact test.|Fisher Exact|The success threshold at each analysis corresponded to a nominal p-value \<0.0130 to maintain an overall one-sided type I error rate of 0.025.||P4 levels of the pooled LutrePulse 15 μg and 20 μg group were compared to placebo.||||0.0553
72562758|NCT01976728|144657342|SUPERIORITY|The hypotheses was tested using a stratified one-sided Fisher's exact test in the FAS including the randomization scheme as the stratification factor.||||||0.0383||||||The SAS PROC FREQ with permutation-based Cochran-Mantel-Haenszel test with exact p-value derived from all possible permutations was employed for the calculation of p-value for the stratified Fisher's exact test.|Fisher Exact|The success threshold at each analysis corresponded to a nominal p-value \<0.0130 to maintain an overall one-sided type I error rate of 0.025.||Clinical pregnancy rates of the pooled LutrePulse 15 μg and 20 μg group were compared to placebo.||||0.0383
72562759|NCT01976728|144657343|SUPERIORITY|The hypotheses were tested using a stratified one-sided Fisher's exact test in the FAS including the randomization scheme as the stratification factor.||||||0.0246||||||The SAS PROC FREQ with permutation-based Cochran-Mantel-Haenszel test with exact p-value derived from all possible permutations was employed for the calculation of p-value for the stratified Fisher's exact test.|Fisher Exact|The success threshold at each analysis corresponded to a nominal p-value \<0.0130 to maintain an overall one-sided type I error rate of 0.025.||Biochemical pregnancy rates of the pooled LutrePulse 15 μg and 20 μg group were compared to placebo.||||0.0246
72562760|NCT01976728|144657344|SUPERIORITY|The hypotheses were tested using a stratified one-sided Fisher's exact test in the FAS including the randomization scheme as the stratification factor.||||||0.0011||||||The SAS PROC FREQ with permutation-based Cochran-Mantel-Haenszel test with exact p-value derived from all possible permutations was employed for the calculation of p-value for the stratified Fisher's exact test.|Fisher Exact|The success threshold at each analysis corresponded to a nominal p-value \<0.0130 to maintain an overall one-sided type I error rate of 0.025.||LH surge detection of the pooled LutrePulse 15 μg and 20 μg group were compared to placebo.||||0.0011
72562761|NCT01976728|144657345|SUPERIORITY|||||||0.1344||||||The p-value was based on the stratified (by randomization scheme) Wilcoxon rank sum test.|Wilcoxon rank sum test|SAS PROC FREQ with modified ridit score (MODRIDIT option) was used for the stratified Wilcoxon rank sum test.||Day 10: Number of follicles with a mean diameter ≥14 mm in the LutrePulse 10 μg group was compared to placebo, using Wilcoxon's rank sum test.||||0.1344
72562762|NCT01976728|144657345|SUPERIORITY|||||||0.2726||||||The p-value was based on the Wilcoxon rank sum test without stratification.|Wilcoxon rank sum test|SAS PROC FREQ with modified ridit score (MODRIDIT option) was used for the stratified Wilcoxon rank sum test.||Day 10: Number of follicles with a mean diameter ≥14 mm in the LutrePulse 15 μg group was compared to placebo, using Wilcoxon's rank sum test.||||0.2726
72562763|NCT01976728|144657345|SUPERIORITY|||||||0.3173||||||The p-value was based on the stratified (by randomization scheme) Wilcoxon rank sum test.|Wilcoxon rank sum test|SAS PROC FREQ with modified ridit score (MODRIDIT option) was used for the stratified Wilcoxon rank sum test.||Day 10: Number of follicles with a mean diameter ≥14 mm in the LutrePulse 20 μg group was compared to placebo, using Wilcoxon's rank sum test.||||0.3173
72562764|NCT01976728|144657345|SUPERIORITY|||||||0.1275||||||The p-value was based on the stratified (by randomization scheme) Wilcoxon rank sum test.|Wilcoxon rank sum test|SAS PROC FREQ with modified ridit score (MODRIDIT option) was used for the stratified Wilcoxon rank sum test.||Day 12: Number of follicles with a mean diameter ≥14 mm in the LutrePulse 10 μg group was compared to placebo, using Wilcoxon's rank sum test.||||0.1275
72562765|NCT01976728|144657345|SUPERIORITY|||||||0.1088||||||The p-value was based on the Wilcoxon rank sum test without stratification.|Wilcoxon rank sum test|SAS PROC FREQ with modified ridit score (MODRIDIT option) was used for the stratified Wilcoxon rank sum test.||Day 12: Number of follicles with a mean diameter ≥14 mm in the LutrePulse 15 μg group was compared to placebo, using Wilcoxon's rank sum test.||||0.1088
72620423|NCT01694771|144772195|SUPERIORITY_OR_OTHER||Mean difference from Tio+Placebo Week 12|-0.478|STANDARD_ERROR_OF_MEAN|0.116|<|0.0001|TWO_SIDED|95.0|-0.706|-0.25|||ANCOVA|||"Week 12: Results are from non-MMRM ANCOVA models by week with LOCF up to each week. Fixed effects include treatment and baseline.~Number of patients contributing to models: Tio+Placebo (561), Tio+Olo 5ug (557)."||-0.250|-0.706|<.0001
72391853|NCT00256750|144290857|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|-0.024|||<|0.0001|TWO_SIDED|95.0|-0.032|-0.016||Missing data were imputed by LOCF. The ridit of the reference group is by definition 0.5.|z-test|The obtained ridits between treatment groups will be compared using z-test at 0.05 significance level for each year.||Symptom Distress, Month 12. For calculation of symptom distress, those symptoms that never occurred will be converted to missing values, in order to avoid anticipatory symptom distress.||-0.016|-0.032|<0.0001
72620424|NCT01694771|144772196|SUPERIORITY_OR_OTHER||Mean difference from Tio+Placebo Week 12|-0.083|STANDARD_ERROR_OF_MEAN|0.041||0.0442|TWO_SIDED|95.0|-0.164|-0.002|||ANCOVA|||"Results are from non-MMRM ANCOVA models by week with LOCF up to each week. Fixed effects include treatment and baseline.~Number of patients contributing to models: Tio+Placebo (561), Tio+Olo 5ug (557)."||-0.002|-0.164|0.0442
72454991|NCT00887224|144433183|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.33||||0.9059|TWO_SIDED|95.0|-5.91|5.24||"P-value obtained from mixed model: change from baseline = baseline + treatment + visit + treatment\*visit with Unstructured covariance structure."|Mixed Models Analysis|Mixed-effects model for repeated measures (MMRM).||Adjusted difference from placebo: Week 26 Absenteeism||5.24|-5.91|0.9059
72454992|NCT00887224|144433183|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.91||||0.0414|TWO_SIDED|95.0|0.27|13.55||"P-value obtained from mixed model: change from baseline = baseline + treatment + visit + treatment\*visit with Unstructured covariance structure."|Mixed Models Analysis|Mixed-effects model for repeated measures (MMRM).||Adjusted difference from placebo: Week 14 Presenteeism||13.55|0.27|0.0414
72454993|NCT00887224|144433183|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.24||||0.0129|TWO_SIDED|95.0|1.77|14.71||"P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment\*visit with Unstructured covariance structure."|Mixed Models Analysis|Mixed-effects model for repeated measures (MMRM).||Adjusted difference from placebo: Week 26 Presenteeism||14.71|1.77|0.0129
72454994|NCT00887224|144433183|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.48||||0.0402|TWO_SIDED|95.0|0.34|14.61||"P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment\*visit with Unstructured covariance structure."|Mixed Models Analysis|Mixed-effects model for repeated measures (MMRM).||Adjusted difference from placebo: Week 14 Work Productivity Loss||14.61|0.34|0.0402
72454995|NCT00887224|144433183|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.48||||0.0187|TWO_SIDED|95.0|1.43|15.53||"P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment\*visit with Unstructured covariance structure."|Mixed Models Analysis|Mixed-effects model for repeated measures (MMRM).||Adjusted difference from placebo: Week 26 Work Productivity Loss||15.53|1.43|0.0187
72562766|NCT01976728|144657345|SUPERIORITY|||||||0.2374||||||The p-value was based on the stratified (by randomization scheme) Wilcoxon rank sum test.|Wilcoxon rank sum test|SAS PROC FREQ with modified ridit score (MODRIDIT option) was used for the stratified Wilcoxon rank sum test.||Day 12: Number of follicles with a mean diameter ≥14 mm in the LutrePulse 20 μg group was compared to placebo, using Wilcoxon's rank sum test.||||0.2374
72562767|NCT01976728|144657345|SUPERIORITY|||||||0.0796||||||The p-value was based on the stratified (by randomization scheme) Wilcoxon rank sum test.|Wilcoxon rank sum test|SAS PROC FREQ with modified ridit score (MODRIDIT option) was used for the stratified Wilcoxon rank sum test.||Day 15: Number of follicles with a mean diameter ≥14 mm in the LutrePulse 10 μg group was compared to placebo, using Wilcoxon's rank sum test||||0.0796
72562768|NCT01976728|144657345|SUPERIORITY|||||||0.1757||||||The p-value was based on the Wilcoxon rank sum test without stratification.|Wilcoxon rank sum test|SAS PROC FREQ with modified ridit score (MODRIDIT option) was used for the stratified Wilcoxon rank sum test.||Day 15: Number of follicles with a mean diameter ≥14 mm in the LutrePulse 15 μg group was compared to placebo, using Wilcoxon's rank sum test||||0.1757
72620425|NCT01694771|144772197|SUPERIORITY_OR_OTHER||Mean difference from Tio+Placebo Week 12|-0.393|STANDARD_ERROR_OF_MEAN|0.098|<|0.0001|TWO_SIDED|95.0|-0.586|-0.2|||ANCOVA|||"Results are from non-MMRM ANCOVA models by week with LOCF up to each week. Fixed effects include treatment and baseline.~Number of patients contributing to models: Tio+Placebo (561), Tio+Olo 5ug (557)."||-0.200|-0.586|<.0001
72620426|NCT00289900|144772204|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-13.2|||<|0.001|TWO_SIDED|95.0|-16.8|-9.6|||ANCOVA|Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate||||-9.6|-16.8|<0.001
72454996|NCT00887224|144433183|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.57|||<|0.001|TWO_SIDED|95.0|3.33|11.8||"P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment\*visit with Unstructured covariance structure."|Mixed Models Analysis|Mixed-effects model for repeated measures (MMRM).||Adjusted difference from placebo: Week 14 Activity Impairment||11.80|3.33|<0.001
72454997|NCT00887224|144433183|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.62|||<|0.001|TWO_SIDED|95.0|3.14|12.1||"P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment\*visit with Unstructured covariance structure."|Mixed Models Analysis|Mixed-effects model for repeated measures (MMRM).||Adjusted difference from placebo: Week 26 Activity Impairment||12.10|3.14|<0.001
72620427|NCT00289900|144772204|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-10.8|||<|0.001|TWO_SIDED|95.0|-13.8|-7.8|||ANCOVA|Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate||||-7.8|-13.8|<0.001
72454998|NCT03883828|144433184|SUPERIORITY||Multivariable Linear Regression|-0.45||||0.004|TWO_SIDED|95.0|-0.75|-0.15||Two-sided p-values equal to or less than 0.05 were considered statistically significant|Fisher Exact|||||-0.15|-0.75|0.004
72454999|NCT03883828|144433185|SUPERIORITY|||||||0.2||||||A 2-sided P ≤ .05 was considered statistically significant|Wilcoxon (Mann-Whitney)|Symptoms Domain||||||0.20
72455000|NCT03883828|144433185|SUPERIORITY|||||||0.05||||||A 2-sided P ≤ .05 was considered statistically significant|Wilcoxon (Mann-Whitney)|Emotions Domain||||||0.05
72455001|NCT03883828|144433185|SUPERIORITY|||||||0.73||||||A 2-sided P ≤ .05 was considered statistically significant|Wilcoxon (Mann-Whitney)|Functioning Domain||||||0.73
72455002|NCT01429454|144433186|SUPERIORITY||Cox Proportional Hazard|0.36||||0.51|TWO_SIDED||||||Chi-squared|||||||.51
72455003|NCT01429454|144433187|SUPERIORITY||||||>|0.1|||||||Mixed Models Analysis|||||||>0.10
72455004|NCT01256359|144433188|SUPERIORITY||Hazard Ratio (HR)|0.753||||0.13|TWO_SIDED|90.0|0.498|1.138||p value \< 0.1 one-sided considered to be significant.|Regression, Cox||HR is Adjusted for M status, performance status|||1.138|0.498|0.130
72620428|NCT00289900|144772204|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-5.1|||<|0.001|TWO_SIDED|95.0|-8.1|-2.1|||ANCOVA|Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate||||-2.1|-8.1|<0.001
72455005|NCT01256359|144433188|SUPERIORITY||Hazard Ratio (HR)|0.723||||0.113|TWO_SIDED|90.0|0.465|1.123|||Regression, Cox||This includes all 83 patients but the analysis additionally adjusted for LDH, target lesion sum and time interval between randomisation and baseline CT scan as well as mstatus, performance status|This is a sensitivity analysis of the primary outcome. This includes all 83 patients but the analysis additionally adjusted for LDH, target lesion sum and time interval between randomisation and baseline CT scan as well as mstatus, performance status||1.123|0.465|0.113
72499886|NCT01307423|144530076|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|7.1|||||TWO_SIDED|95.0|-7.2|21.5|||||Two-sided 95% CI of the proportion difference is based on the normal approximation to the binomial distribution.|||21.5|-7.2|
72562769|NCT01976728|144657345|SUPERIORITY|||||||0.0584||||||The p-value was based on the stratified (by randomization scheme) Wilcoxon rank sum test.|Wilcoxon rank sum test|SAS PROC FREQ with modified ridit score (MODRIDIT option) was used for the stratified Wilcoxon rank sum test.||Day 15: Number of follicles with a mean diameter ≥14 mm in the LutrePulse 20 μg group was compared to placebo, using Wilcoxon's rank sum test.||||0.0584
72562770|NCT01976728|144657345|SUPERIORITY|||||||0.3711||||||The p-value was based on the stratified (by randomization scheme) Wilcoxon rank sum test.|Wilcoxon rank sum test|SAS PROC FREQ with modified ridit score (MODRIDIT option) was used for the stratified Wilcoxon rank sum test.||Day 18: Number of follicles with a mean diameter ≥14 mm in the LutrePulse 10 μg group was compared to placebo, using Wilcoxon's rank sum test.||||0.3711
72562771|NCT01976728|144657345|SUPERIORITY|||||||0.0143||||||The p-value was based on the Wilcoxon rank sum test without stratification.|Wilcoxon rank sum test|SAS PROC FREQ with modified ridit score (MODRIDIT option) was used for the stratified Wilcoxon rank sum test.||Day 18: Number of follicles with a mean diameter ≥14 mm in the LutrePulse 15 μg group was compared to placebo, using Wilcoxon's rank sum test.||||0.0143
72562772|NCT01976728|144657345|SUPERIORITY|||||||0.006||||||The p-value was based on the stratified (by randomization scheme) Wilcoxon rank sum test.|Wilcoxon rank sum test|SAS PROC FREQ with modified ridit score (MODRIDIT option) was used for the stratified Wilcoxon rank sum test.||Day 18: Number of follicles with a mean diameter ≥14 mm in the LutrePulse 20 μg group was compared to placebo, using Wilcoxon's rank sum test.||||0.0060
72562773|NCT01976728|144657345|SUPERIORITY|||||||0.1573||||||The p-value was based on the stratified (by randomization scheme) Wilcoxon rank sum test.|Wilcoxon rank sum test|SAS PROC FREQ with modified ridit score (MODRIDIT option) was used for the stratified Wilcoxon rank sum test.||Day 21: Number of follicles with a mean diameter ≥14 mm in the LutrePulse 20 μg group was compared to placebo, using Wilcoxon's rank sum test.||||0.1573
72562774|NCT01976728|144657346|SUPERIORITY|||||||0.4142||||||The p-value was based on the Wilcoxon rank sum test without stratification.|Wilcoxon rank sum test|SAS PROC FREQ with modified ridit score (MODRIDIT option) was used for the stratified Wilcoxon rank sum test.||Day 12: Number of follicles with a mean diameter ≥18 mm in the LutrePulse 15 μg group was compared to placebo, using Wilcoxon's rank sum test.||||0.4142
72562775|NCT01976728|144657346|SUPERIORITY|||||||0.2374||||||The p-value was based on the stratified (by randomization scheme) Wilcoxon rank sum test.|Wilcoxon rank sum test|SAS PROC FREQ with modified ridit score (MODRIDIT option) was used for the stratified Wilcoxon rank sum test.||Number of follicles with a mean diameter ≥18 mm in the LutrePulse 20 μg group was compared to placebo, using Wilcoxon's rank sum test.||||0.2374
72562776|NCT01976728|144657346|SUPERIORITY|||||||0.2636||||||The p-value was based on the stratified (by randomization scheme) Wilcoxon rank sum test.|Wilcoxon rank sum test|SAS PROC FREQ with modified ridit score (MODRIDIT option) was used for the stratified Wilcoxon rank sum test.||Day 15: Number of follicles with a mean diameter ≥18 mm in the LutrePulse 10 μg group was compared to placebo, using Wilcoxon's rank sum test.||||0.2636
72562777|NCT01976728|144657346|SUPERIORITY|||||||0.4795||||||The p-value was based on the Wilcoxon rank sum test without stratification.|Wilcoxon rank sum test|SAS PROC FREQ with modified ridit score (MODRIDIT option) was used for the stratified Wilcoxon rank sum test.||Day 15: Number of follicles with a mean diameter ≥18 mm in the LutrePulse 15 μg group was compared to placebo, using Wilcoxon's rank sum test.||||0.4795
72562778|NCT01976728|144657346|SUPERIORITY|||||||0.3173||||||The p-value was based on the stratified (by randomization scheme) Wilcoxon rank sum test.|Wilcoxon rank sum test|SAS PROC FREQ with modified ridit score (MODRIDIT option) was used for the stratified Wilcoxon rank sum test.||Day 15: Number of follicles with a mean diameter ≥18 mm in the LutrePulse 20 μg group was compared to placebo, using Wilcoxon's rank sum test.||||0.3173
72562779|NCT01976728|144657346|SUPERIORITY|||||||0.3711||||||The p-value was based on the stratified (by randomization scheme) Wilcoxon rank sum test.|Wilcoxon rank sum test|SAS PROC FREQ with modified ridit score (MODRIDIT option) was used for the stratified Wilcoxon rank sum test.||Day 18: Number of follicles with a mean diameter ≥18 mm in the LutrePulse 10 μg group was compared to placebo, using Wilcoxon's rank sum test.||||0.3711
72562780|NCT01976728|144657346|SUPERIORITY|||||||0.4142||||||The p-value was based on the Wilcoxon rank sum test without stratification.|Wilcoxon rank sum test|SAS PROC FREQ with modified ridit score (MODRIDIT option) was used for the stratified Wilcoxon rank sum test.||Day 18: Number of follicles with a mean diameter ≥18 mm in the LutrePulse 15 μg group was compared to placebo, using Wilcoxon's rank sum test.||||0.4142
72562781|NCT01976728|144657346|SUPERIORITY|||||||0.0838||||||The p-value was based on the stratified (by randomization scheme) Wilcoxon rank sum test.|Wilcoxon rank sum test|SAS PROC FREQ with modified ridit score (MODRIDIT option) was used for the stratified Wilcoxon rank sum test.||Day 18: Number of follicles with a mean diameter ≥18 mm in the LutrePulse 20 μg group was compared to placebo, using Wilcoxon's rank sum test.||||0.0838
72620429|NCT00289900|144772204|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-4.2||||0.007|TWO_SIDED|95.0|-7.2|-1.2|||ANCOVA|Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate||||-1.2|-7.2|0.007
72620430|NCT00289900|144772205|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|19.9|||<|0.001|TWO_SIDED|95.0|17.2|22.6|||ANCOVA|Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate||||22.6|17.2|<0.001
72620431|NCT00289900|144772205|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|21.3|||<|0.001|TWO_SIDED|95.0|19.0|23.6|||ANCOVA|Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate||||23.6|19.0|<0.001
72620432|NCT00289900|144772205|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|22.1|||<|0.001|TWO_SIDED|95.0|19.8|24.4|||ANCOVA|Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate||||24.4|19.8|<0.001
72620433|NCT00289900|144772205|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|23.0|||<|0.001|TWO_SIDED|95.0|20.7|25.3|||ANCOVA|Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate||||25.3|20.7|<0.001
72620434|NCT00289900|144772206|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-17.3|||<|0.001|TWO_SIDED|95.0|-21.2|-13.3|||Non-parametric ANOVA|Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate|Hodges-Lehmann estimate of the difference between treatments with a corresponding distribution-free confidence interval (CI) based on Wilcoxon's rank sum test|||-13.3|-21.2|<0.001
72620435|NCT00289900|144772206|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-15.5|||<|0.001|TWO_SIDED|95.0|-19.1|-11.9|||Non-parametric ANOVA|Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate|Hodges-Lehmann estimate of the difference between treatments with a corresponding distribution-free CI based on Wilcoxon's rank sum test|||-11.9|-19.1|<0.001
72620436|NCT00289900|144772206|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-10.3|||<|0.001|TWO_SIDED|95.0|-13.7|-7.0|||Non-parametric ANOVA|Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate|Hodges-Lehmann estimate of the difference between treatments with a corresponding distribution-free CI based on Wilcoxon's rank sum test|||-7.0|-13.7|<0.001
72620437|NCT00289900|144772206|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-6.8|||<|0.001|TWO_SIDED|95.0|-10.2|-3.4|||Non-parametric ANOVA|Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate|Hodges-Lehmann estimate of the difference between treatments with a corresponding distribution-free CI based on Wilcoxon's rank sum test|||-3.4|-10.2|<0.001
72620438|NCT00289900|144772207|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-9.1|||<|0.001|TWO_SIDED|95.0|-12.1|-6.0|||ANCOVA|Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate||||-6.0|-12.1|<0.001
72620439|NCT00289900|144772207|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-5.4|||<|0.001|TWO_SIDED|95.0|-8.0|-2.9|||ANCOVA|Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate||||-2.9|-8.0|<0.001
72620440|NCT00289900|144772207|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|0.4||||0.771|TWO_SIDED|95.0|-2.2|2.9|||ANCOVA|Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate||||2.9|-2.2|0.771
72620441|NCT00289900|144772207|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|2.4||||0.065|TWO_SIDED|95.0|-0.2|5.0|||ANCOVA|Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate||||5.0|-0.2|0.065
72620442|NCT00289900|144772208|SUPERIORITY_OR_OTHER||Difference in least Squares Mean|-6.8|||<|0.001|TWO_SIDED|95.0|-10.2|-3.5|||ANCOVA|Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate||||-3.5|-10.2|<0.001
72455006|NCT01256359|144433188|SUPERIORITY|||||||0.3016||||||This analysis assesses if allowing for interval censoring is consistent with the primary outcome results.|Generalised log-rank|Generalised log-rank taking into account interval censoring, analysed using SAS package version 9.2. Method by Zhao and Sun, 2004||This is a sensitivity analysis, including all 83 randomised patients. Patients are assessed periodically for the response (progression), the time when the event occurred is not directly observed but is known to take place within some time interval. Progression is known only to have occurred at some time between visits, the exact time is not known. We carried out interval censored analysis to demonstrate if allowing for interval censoring gives a different interpretation of the primary outcome.||||0.3016
72455007|NCT01256359|144433188|SUPERIORITY||Hazard Ratio (HR)|1.348||||0.305|TWO_SIDED|90.0|0.602|3.016|||Regression, Cox||Adjusted for centre|Sensitivity analysis adjusting for centre. All 83 randomised patients were included in analysis. Centres were the three biggest recruiters and all other 13 centres are combined.||3.016|0.602|0.305
72620443|NCT00289900|144772208|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-3.0||||0.037|TWO_SIDED|95.0|-5.8|-0.2|||ANCOVA|Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate||||-0.2|-5.8|0.037
72620444|NCT00289900|144772208|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|2.8||||0.047|TWO_SIDED|95.0|0.0|5.6|||ANCOVA|Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate||||5.6|0.0|0.047
72620445|NCT00289900|144772208|SUPERIORITY_OR_OTHER||Difference in Least Sqaures Mean|4.7|||<|0.001|TWO_SIDED|95.0|2.0|7.5|||ANCOVA|Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate||||7.5|2.0|<0.001
72620446|NCT00289900|144772209|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-9.2|||<|0.001|TWO_SIDED|95.0|-12.1|-6.3|||ANCOVA|Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate||||-6.3|-12.1|<0.001
72620447|NCT00289900|144772209|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-5.2|||<|0.001|TWO_SIDED|95.0|-7.7|-2.8|||ANCOVA|Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate||||-2.8|-7.7|<0.001
72620448|NCT00289900|144772209|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-0.9||||0.476|TWO_SIDED|95.0|-3.3|1.5|||ANCOVA|Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate||||1.5|-3.3|0.476
72620449|NCT00289900|144772209|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|0.2||||0.845|TWO_SIDED|95.0|-2.2|2.7|||ANCOVA|Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate||||2.7|-2.2|0.845
72620450|NCT00289900|144772210|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|9.0|||<|0.001|TWO_SIDED|95.0|6.6|11.4|||ANCOVA|Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate||||11.4|6.6|<0.001
72455008|NCT01256359|144433189|SUPERIORITY||Mean Difference (Final Values)|14.0||||0.187|TWO_SIDED|90.0|-3.4|31.4|||Log Rank||This is the estimated difference in PFS rate i.e. % difference between arms|||31.4|-3.4|0.187
72455009|NCT01256359|144433190|SUPERIORITY||Hazard Ratio (HR)|1.373||||0.169|TWO_SIDED|90.0|0.797|2.369|||Regression, Cox|p value \< 0.1 one-sided considered to be significant.||||2.369|0.797|0.169
72455010|NCT01256359|144433191|SUPERIORITY|||||||0.059|||||||Chi-squared|||Objective response rate calculated as number of patients with CR or PR over all patients randomised.||||0.059
72455011|NCT01256359|144433192|SUPERIORITY||Hazard Ratio (HR)|1.15||||0.318|TWO_SIDED|90.0|0.71|1.84|||Regression, Cox|||Analysis adjusted for with Mstatus and Performance Score||1.84|0.71|0.318
72455012|NCT01256359|144433230|SUPERIORITY||Hazard Ratio (HR)|1.022||||0.468|TWO_SIDED|90.0|0.649|1.612|||Regression, Cox||Analysis Adjusted for M status, performance status|This is a sensitivity analysis of the primary outcome.||1.612|0.649|0.468
72455013|NCT01256359|144433231|SUPERIORITY||Hazard Ratio (HR)|0.721||||0.106|TWO_SIDED|90.0|0.468|1.109|||Regression, Cox||Analysis was adjusted for mstatus, performance status|This is the per-protocol analysis of the primary outcome.||1.109|0.468|0.106
72455014|NCT01256359|144433232|SUPERIORITY||Hazard Ratio (HR)|0.63||||0.824|TWO_SIDED|95.0|0.25|1.53||p-value is for the interaction term|Regression, Cox||HRs (95% CI) between treatment groups are given for Wild type and NRAS mutated separately. The above HR is for WT.|Model with interaction term between NRAS status and treatment group and stratification variables||1.53|0.25|0.824
72455015|NCT01256359|144433233|SUPERIORITY||Hazard Ratio (HR)|0.51||||0.072|TWO_SIDED|95.0|0.16|1.6||p-value is for interaction term.|Regression, Cox|Model includes interaction term between NRAS status and treatment group and stratification variables|"HRs for treatment effect (AZD6244 vs Placebo ) are estimated for NRAS WT and NRAS mutated patients separately.~Hazard ratios (95%CI) given above are for NRAS WT patients."|||1.60|0.16|0.072
72455016|NCT01256359|144433233|SUPERIORITY||Hazard Ratio (HR)|1.97|||||TWO_SIDED|95.0|0.73|5.33|||||HR for NRAS mutated patients|||5.33|0.73|
72455017|NCT01256359|144433235|SUPERIORITY|Adjusted for with Mstatus and Performance Score|Hazard Ratio (HR)|1.12||||0.348|TWO_SIDED|90.0|0.68|1.87|||Regression, Cox|||||1.87|0.68|0.348
72455018|NCT01256359|144433236|SUPERIORITY||Hazard Ratio (HR)|0.61||||0.797|TWO_SIDED|90.0|0.24|1.58||p-value is for interaction term.|Regression, Cox|Model includes interaction term between NRAS status and treatment group and stratification variables|"HRs for treatment effect (AZD6244 vs Placebo ) are estimated for NRAS WT and NRAS mutated patients separately.~Hazard ratios (95%CI) given above are for NRAS WT patients."|||1.58|0.24|0.797
72455019|NCT01256359|144433236|SUPERIORITY||Hazard Ratio (HR)|0.71|||||TWO_SIDED|95.0|0.35|1.45|||||HR for NRAS mutated patients|||1.45|0.350|
72455020|NCT01256359|144433237|SUPERIORITY||Hazard Ratio (HR)|0.6||||0.12|TWO_SIDED|95.0|0.18|1.97||Model includes interaction term between NRAS status and treatment group and stratification variables. p-value is for interaction term.|Regression, Cox||"HRs for treatment effect (AZD6244 vs Placebo ) are estimated for NRAS WT and NRAS mutated patients separately.~Hazard ratios (95%CI) given above are for NRAS WT patients."|||1.97|0.18|0.120
72455021|NCT01256359|144433237|SUPERIORITY||Hazard Ratio (HR)|1.99|||||TWO_SIDED|95.0|0.73|5.38|||||HR for NRAS mutated patients|||5.38|0.73|
72455022|NCT02000752|144433239|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.98|||<|0.001|ONE_SIDED|95.0|7.59||||t-test, 1 sided||||||7.59|<0.001
72455023|NCT02000752|144433240|SUPERIORITY_OR_OTHER||difference in percentage|0.0||||1|TWO_SIDED|95.0|||||t-test, 2 sided|||||||1
72620451|NCT00289900|144772210|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|7.7|||<|0.001|TWO_SIDED|95.0|5.8|9.7|||ANCOVA|Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate||||9.7|5.8|<0.001
72455024|NCT02000752|144433241|SUPERIORITY_OR_OTHER||difference in percentages|2.13||||0.16|ONE_SIDED|95.0|1.01||||t-test, 1 sided||||||1.01|0.16
72455025|NCT02000752|144433242|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.84||||0.2|ONE_SIDED|95.0|0.84||||t-test, 2 sided||||||0.84|0.2
72455026|NCT04938453|144433248|OTHER||Ratio of GLSMs (%)|98.47|STANDARD_ERROR_OF_MEAN|13.9|||TWO_SIDED|90.0|90.87|106.69|||||"Ratio of Geometric Least Squares Means (GLSMs) was calculated as (GLSM of nintedanib 4 X 25 mg)/(GLSM of nintedanib 1 X 100 mg).~Standard error of the mean is actually intra-individual geometric coefficient of variation (gCV \[%\])."|The statistical model used for the analysis of this primary endpoint was an analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: sequence, subjects within sequences, period and treatment. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||106.69|90.87|
72455027|NCT04938453|144433249|OTHER||Ratio of GLSMs (%)|100.29|STANDARD_ERROR_OF_MEAN|29.2|||TWO_SIDED|90.0|85.05|118.24|||||"Ratio of Geometric Least Squares Means (GLSMs) was calculated as (GLSM of nintedanib 4 X 25 mg)/(GLSM of nintedanib 1 X 100 mg).~Standard error of the mean is actually intra-individual geometric coefficient of variation (gCV \[%\])."|The statistical model used for the analysis of this primary endpoint was an analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: sequence, subjects within sequences, period and treatment. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||118.24|85.05|
72455028|NCT04938453|144433250|OTHER||Ratio of GLSMs (%)|98.92|STANDARD_ERROR_OF_MEAN|13.8|||TWO_SIDED|90.0|91.35|107.12|||||"Ratio of Geometric Least Squares Means (GLSMs) was calculated as (GLSM of nintedanib 4 X 25 mg)/(GLSM of nintedanib 1 X 100 mg).~Standard error of the mean is actually intra-individual geometric coefficient of variation (gCV \[%\])."|The statistical model used for the analysis of this primary endpoint was an analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: sequence, subjects within sequences, period and treatment. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||107.12|91.35|
72620452|NCT00289900|144772210|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|9.0|||<|0.001|TWO_SIDED|95.0|7.0|10.9|||ANCOVA|Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate||||10.9|7.0|<0.001
72620453|NCT00289900|144772210|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|10.7|||<|0.001|TWO_SIDED|95.0|8.7|12.7|||ANCOVA|Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate||||12.7|8.7|<0.001
72620454|NCT00289900|144772211|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-3.6||||0.003|TWO_SIDED|95.0|-6.0|-1.2|||ANCOVA|Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate||||-1.2|-6.0|0.003
72620455|NCT00289900|144772211|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-0.5||||0.595|TWO_SIDED|95.0|-2.5|1.5|||ANCOVA|Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate||||1.5|-2.5|0.595
72620456|NCT00289900|144772211|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|4.2|||<|0.001|TWO_SIDED|95.0|2.2|6.2|||ANCOVA|Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate||||6.2|2.2|<0.001
72620457|NCT00289900|144772211|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|6.1|||<|0.001|TWO_SIDED|95.0|4.1|8.1|||ANCOVA|Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate||||8.1|4.1|<0.001
72455029|NCT04658784|144433255|SUPERIORITY||Odds Ratio (OR)|0.51||||0.32|TWO_SIDED|95.0|0.13|1.92||OR, 95% CI, and p-values for outcomes adjusted for baseline value and type of surgery (vaginal or vaginal + minimally invasive surgery). P-value for VAS at 6-weeks was not adjusted for multiple comparisons.|Regression, Logistic|||OR calculated from logistic regression model, evaluating mean change in baseline VAS to 6-weeks.||1.92|0.13|0.32
72620458|NCT00289900|144772212|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-18.8|||<|0.001|TWO_SIDED|95.0|-24.2|-14.2|||Non-parametric ANOVA|Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate|Hodges-Lehmann estimate of the difference between treatments with a corresponding distribution-free CI based on Wilcoxon's rank sum test|||-14.2|-24.2|<0.001
72620459|NCT00289900|144772212|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-20.5|||<|0.001|TWO_SIDED|95.0|-25.0|-16.6|||Non-parametric ANOVA|Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate|Hodges-Lehmann estimate of the difference between treatments with a corresponding distribution-free CI based on Wilcoxon's rank sum test|||-16.6|-25.0|<0.001
72620460|NCT00289900|144772212|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-23.9|||<|0.001|TWO_SIDED|95.0|-27.8|-19.4|||Non-parametric ANOVA|Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate|Hodges-Lehmann estimate of the difference between treatments with a corresponding distribution-free CI based on Wilcoxon's rank sum test|||-19.4|-27.8|<0.001
72620461|NCT00289900|144772212|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-24.6|||<|0.001|TWO_SIDED|95.0|-28.6|-20.0|||Non-parametric ANOVA|Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate|Hodges-Lehmann estimate of the difference between treatments with a corresponding distribution-free CI based on Wilcoxon's rank sum test|||-20.0|-28.6|<0.001
72455030|NCT04658784|144433256|SUPERIORITY||Odds Ratio (OR)|0.48||||1|TWO_SIDED|95.0|0.04|5.65||OR, 95% CI, and p-values for outcomes adjusted for baseline value and type of surgery (vaginal or vaginal + minimally invasive surgery). P-value for VAS at 6-weeks was not adjusted for multiple comparisons.|Regression, Logistic|||OR calculated from logistic regression model, evaluating mean change in baseline VAS to 6-weeks.||5.65|0.04|1.0
72455031|NCT04658784|144433259|SUPERIORITY||Mean Difference (Net)|2.6||||1|TWO_SIDED|95.0|-3.5|8.7||Adjust for baseline value and type of surgery (vaginal or vaginal + minimally invasive surgery).|Regression, Linear|||Differences in mean change and 95% CI generated from general linear models. Change from baseline to 6- weeks.||8.7|-3.5|1.0
72455032|NCT04658784|144433259|SUPERIORITY||Mean Difference (Net)|-1.2|||||TWO_SIDED|95.0|-5.6|3.2||Adjust for baseline value and type of surgery (vaginal or vaginal + minimally invasive surgery).|Regression, Linear|||Differences in mean change and 95% CI generated from general linear models. Change from baseline to 6-months.||3.2|-5.6|
72620462|NCT00289900|144772213|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.8||||0.5|TWO_SIDED|95.0|-9.6|7.5|||Non-parametric ANOVA|Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate|Hodges-Lehmann estimate of the difference between treatments with a corresponding distribution-free CI based on Wilcoxon's rank sum test|||7.5|-9.6|0.500
72620463|NCT00289900|144772213|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|6.9||||0.083|TWO_SIDED|95.0|0.0|13.8|||Non-parametric ANOVA|Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate|Hodges-Lehmann estimate of the difference between treatments with a corresponding distribution-free CI based on Wilcoxon's rank sum test|||13.8|0.0|0.083
72620464|NCT00289900|144772213|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|11.9||||0.005|TWO_SIDED|95.0|5.2|18.8|||Non-parametric ANOVA|Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate|Hodges-Lehmann estimate of the difference between treatments with a corresponding distribution-free CI based on Wilcoxon's rank sum test|||18.8|5.2|0.005
72620465|NCT00289900|144772213|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|16.4|||<|0.001|TWO_SIDED|95.0|9.8|22.8|||Non-parametric ANOVA|Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate|Hodges-Lehmann estimate of the difference between treatments with a corresponding distribution-free CI based on Wilcoxon's rank sum test|||22.8|9.8|<0.001
72499887|NCT01307423|144530077|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|6.5|||||TWO_SIDED|95.0|-4.8|17.7|||||Two-sided 95% CI of the proportion difference is based on the normal approximation to the binomial distribution.|||17.7|-4.8|
72499888|NCT01307423|144530077|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|15.2|||||TWO_SIDED|95.0|3.4|27.1|||||Two-sided 95% CI of the proportion difference is based on the normal approximation to the binomial distribution.|||27.1|3.4|
72620466|NCT00289900|144772214|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-12.8|||<|0.001|TWO_SIDED|95.0|-15.6|-9.9|||ANCOVA|Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate||||-9.9|-15.6|<0.001
72620467|NCT00289900|144772214|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-10.8|||<|0.001|TWO_SIDED|95.0|-13.2|-8.4|||ANCOVA|Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate||||-8.4|-13.2|<0.001
72455033|NCT04658784|144433260|SUPERIORITY||Mean Difference (Net)|0.2||||1|TWO_SIDED|95.0|-6.6|6.9||Adjust for baseline value and type of surgery (vaginal or vaginal + minimally invasive surgery).|Regression, Linear|||Differences in mean change and 95% CI generated from general linear models. Change in baseline to 6-weeks.||6.9|-6.6|1.0
72455034|NCT04658784|144433260|SUPERIORITY|Differences in mean change and 95% CI generated from general linear models. Change in baseline to 6-months.|Mean Difference (Net)|2.8||||1|TWO_SIDED|95.0|-3.1|8.6||Adjusted for baseline value and type of surgery (vaginal or vaginal + minimally invasive surgery).|Regression, Linear|||||8.6|-3.1|1
72455035|NCT04658784|144433261|SUPERIORITY||Mean Difference (Net)|-1.6||||1|TWO_SIDED|95.0|-4.4|1.3||Adjusted for baseline value and type of surgery (vaginal or vaginal + minimally invasive surgery).|Regression, Linear|||Differences in mean change and 95% CI generated from general linear models. Change from baseline to 6 months.||1.3|-4.4|1.0
72455036|NCT02095145|144433273|OTHER|||||||0.19|||||||Wilcoxon rank-sum test|||||||0.190
72455037|NCT02095145|144433273|OTHER|||||||0.211|||||||t-test, 2 sided|||||||0.211
72455038|NCT02095145|144433276|OTHER|||||||0.948|||||||Wilcoxon rank-sum test|||Baseline to Week 13 p-value||||0.948
72455039|NCT02095145|144433276|OTHER|||||||0.711|||||||Wilcoxon rank-sum test|||Baseline to Week 26 p-value||||0.711
72455040|NCT02095145|144433276|OTHER|||||||0.038|||||||Wilcoxon rank-sum test|||Baseline to Week 39 p-value||||0.038
72455041|NCT02095145|144433276|OTHER|||||||0.445|||||||Wilcoxon rank-sum test|||Baseline to Week 52 p-value||||0.445
72455042|NCT02095145|144433277|OTHER|||||||0.743|||||||Wilcoxon rank-sum test|||Baseline to Week 13 p-value||||0.743
72455043|NCT02095145|144433277|OTHER|||||||0.305|||||||Wilcoxon rank-sum test|||Baseline to Week 26 p-value||||0.305
72455044|NCT02095145|144433277|OTHER|||||||0.111|||||||Wilcoxon rank-sum test|||Baseline to Week 39 p-value||||0.111
72455045|NCT02095145|144433277|OTHER|||||||0.395|||||||Wilcoxon rank-sum test|||Baseline to Week 52 p-value||||0.395
72455046|NCT02095145|144433278|OTHER|||||||0.743|||||||Wilcoxon rank-sum test|||Change from Baseline PSA to Week 13||||0.743
72455047|NCT02095145|144433278|OTHER|||||||0.527|||||||Wilcoxon rank-sum test|||Change from Baseline PSA to Week 26||||0.527
72499889|NCT01307423|144530078|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|10.5|||||TWO_SIDED|95.0|-3.8|24.8|||||Two-sided 95% CI of the proportion difference is based on the normal approximation to the binomial distribution.|||24.8|-3.8|
72455048|NCT02095145|144433278|OTHER|||||||0.879|||||||Wilcoxon rank-sum test|||Change from Baseline PSA to Week 39||||0.879
72499890|NCT01307423|144530078|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|4.9|||||TWO_SIDED|95.0|-9.5|19.3|||||Two-sided 95% CI of the proportion difference is based on the normal approximation to the binomial distribution.|||19.3|-9.5|
72504810|NCT03114969|144540516|SUPERIORITY||Odds Ratio (OR)|3.804||||0.01|TWO_SIDED|95.0|1.372|10.544||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.|||10.544|1.372|0.010
72620468|NCT00289900|144772214|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-6.4||||0.001|TWO_SIDED|95.0|-8.8|-4.0|||ANCOVA|Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate||||-4.0|-8.8|0.001
72455049|NCT02095145|144433278|OTHER|||||||0.81|||||||Wilcoxon rank-sum test|||Change from Baseline PSA to Week 52||||0.810
72455050|NCT02095145|144433279|OTHER|||||||0.556|||||||Wilcoxon rank-sum test|||Comparison of both arms at baseline||||0.556
72455051|NCT02095145|144433279|OTHER|||||||0.647|||||||Wilcoxon rank-sum test|||comparison of both arms at Week 26||||0.647
72455052|NCT02095145|144433279|OTHER|||||||0.948|||||||Wilcoxon rank-sum test|||comparison of both arms at end of study, week 52||||0.948
72455053|NCT02095145|144433280|OTHER|||||||0.58|||||||Wilcoxon rank-sum test|||||||0.580
72455054|NCT02095145|144433281|OTHER|||||||0.344|||||||Wilcoxon rank-sum test|||Benign core p-value||||0.344
72455055|NCT02095145|144433281|OTHER|||||||0.371|||||||Wilcoxon rank-sum test|||Adjacent core p-value||||0.371
72455056|NCT02095145|144433281|OTHER|||||||0.766|||||||Wilcoxon rank-sum test|||Tumor core p-value||||0.766
72455057|NCT02095145|144433282|OTHER|||||||0.304|||||||Wilcoxon rank-sum test|||Change from Baseline: IGF-1 Benign (Nuc)||||0.304
72455058|NCT02095145|144433282|OTHER|||||||0.23|||||||Wilcoxon rank-sum test|||Change from Baseline: IGF-1 Adjacent (Nuc)||||0.230
72455059|NCT02095145|144433282|OTHER|||||||0.298|||||||Wilcoxon rank-sum test|||Change from Baseline: IGF-1 Tumor (Nuc)||||0.298
72455060|NCT02095145|144433282|OTHER|||||||0.247|||||||Wilcoxon rank-sum test|||Change from Baseline: IGF-1 Benign (Cyt)||||0.247
72455061|NCT02095145|144433282|OTHER|||||||0.093|||||||Wilcoxon rank-sum test|||Change from Baseline: IGF-1 Adjacent (Cyt)||||0.093
72455062|NCT02095145|144433282|OTHER|||||||0.066|||||||Wilcoxon rank-sum test|||Change from Baseline: IGF-1 Tumor (Cyt)||||0.066
72455063|NCT02095145|144433282|OTHER|||||||0.247|||||||Wilcoxon rank-sum test|||Change from Baseline: IGF-1 Benign (Cell)||||0.247
72455064|NCT02095145|144433282|OTHER|||||||0.128|||||||Wilcoxon rank-sum test|||Change from Baseline: IGF-1 Adjacent (Cell)||||0.128
72455065|NCT02095145|144433282|OTHER|||||||0.128|||||||Wilcoxon rank-sum test|||Change from Baseline: IGF-1 Tumor (Cell)||||0.128
72455066|NCT02095145|144433283|OTHER|||||||0.297|||||||Wilcoxon rank-sum test|||Change From Baseline: Nuc Benign p-value||||0.297
72455067|NCT02095145|144433283|OTHER|||||||0.233|||||||Wilcoxon rank-sum test|||Change From Baseline: Nuc Adjacent p-value||||0.233
72455068|NCT02095145|144433283|OTHER|||||||0.371|||||||Wilcoxon rank-sum test|||Change From Baseline: Nuc Tumor p-value||||0.371
72455069|NCT02095145|144433283|OTHER|||||||0.198|||||||Wilcoxon rank-sum test|||Change From Baseline: Cyt Benign p-value||||0.198
72620469|NCT00289900|144772214|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-5.6|||<|0.001|TWO_SIDED|95.0|-8.0|-3.2|||ANCOVA|Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate||||-3.2|-8.0|<0.001
72620470|NCT00289900|144772215|SUPERIORITY_OR_OTHER||Difference in Proportion|-1.4||||0.008|TWO_SIDED|95.0|-2.3|-0.5|||Miettinen and Nurminen|||||-0.5|-2.3|0.008
72620471|NCT00289900|144772216|SUPERIORITY_OR_OTHER||Difference in Proportion|-0.7||||0.042|TWO_SIDED|95.0|-1.4|0.0|||Miettinen and Nurminen|||||-0.0|-1.4|0.042
72455070|NCT02095145|144433283|OTHER|||||||0.233|||||||Wilcoxon rank-sum test|||Change From Baseline: Cyt Adjacent p-value||||0.233
72620472|NCT00289900|144772217|SUPERIORITY_OR_OTHER||Difference in Proportion|-0.1||||0.346|TWO_SIDED|95.0|-0.5|0.4|||Miettinen and Nurminen|||||0.4|-0.5|0.346
72620473|NCT00289900|144772218|SUPERIORITY_OR_OTHER||Difference in Proportion|0.1||||0.556|TWO_SIDED|95.0|-0.2|0.7|||Miettinen and Nurminen|||||0.7|-0.2|0.556
72620474|NCT00289900|144772219|SUPERIORITY_OR_OTHER||Difference in Proportion|0.1||||0.134|TWO_SIDED|95.0|-0.1|0.8|||Miettinen and Nurminen|||||0.8|-0.1|0.134
72455071|NCT02095145|144433283|OTHER|||||||0.074|||||||Wilcoxon rank-sum test|||Change From Baseline: Cyt Tumor p-value||||0.074
72455072|NCT02095145|144433283|OTHER|||||||0.234|||||||Wilcoxon rank-sum test|||Change From Baseline: Cell Benign p-value||||0.234
72455073|NCT02095145|144433283|OTHER|||||||0.233|||||||Wilcoxon rank-sum test|||Change From Baseline: Cell Adjacent p-value||||0.233
72455074|NCT02095145|144433283|OTHER|||||||0.233|||||||Wilcoxon rank-sum test|||Change From Baseline: Cell Tumor p-value||||0.233
72455075|NCT02095145|144433284|OTHER|||||||0.167|||||||Wilcoxon rank-sum test|||Change From Baseline: Nuc Benign p-value||||0.167
72455076|NCT02095145|144433284|OTHER|||||||0.391|||||||Wilcoxon rank-sum test|||Change From Baseline: Nuc Adjacent p-value||||0.391
72455077|NCT02095145|144433284|OTHER|||||||0.713|||||||Wilcoxon rank-sum test|||Change From Baseline: Nuc Tumor p-value||||0.713
72455078|NCT02095145|144433284|OTHER|||||||0.452|||||||Wilcoxon rank-sum test|||Change From Baseline: Cyt Benign p-value||||0.452
72455079|NCT02095145|144433284|OTHER|||||||0.391|||||||Wilcoxon rank-sum test|||Change From Baseline: Cyt Adjacent p-value||||0.391
72455080|NCT02095145|144433284|OTHER|||||||0.713|||||||Wilcoxon rank-sum test|||Change From Baseline: Cyt Tumor p-value||||0.713
72455081|NCT02095145|144433284|OTHER|||||||0.344|||||||Wilcoxon rank-sum test|||Change From Baseline: Cell Benign p-value||||0.344
72455082|NCT02095145|144433284|OTHER|||||||0.391|||||||Wilcoxon rank-sum test|||Change From Baseline: Cell Adjacent p-value||||0.391
72455083|NCT02095145|144433284|OTHER|||||||0.713|||||||Wilcoxon rank-sum test|||Change From Baseline: Cell Tumor p-value||||0.713
72455084|NCT02095145|144433285|OTHER|||||||0.865|||||||Wilcoxon rank-sum test|||Change from Baseline: Benign p-value||||0.865
72455085|NCT02095145|144433285|OTHER|||||||1|||||||Wilcoxon rank-sum test|||Change from Baseline: Adjacent p-value||||1.000
72455086|NCT02095145|144433285|OTHER|||||||0.066|||||||Wilcoxon rank-sum test|||Change from Baseline: Tumor p-value||||0.066
72455087|NCT02095145|144433286|OTHER|||||||1|||||||Wilcoxon rank-sum test|||Change from Baseline: Nuc Benign p-value||||1.000
72455088|NCT02095145|144433286|OTHER|||||||0.903|||||||Wilcoxon rank-sum test|||Change from Baseline: Nuc Adjacent p-value||||0.903
72455089|NCT02095145|144433286|OTHER|||||||1|||||||Wilcoxon rank-sum test|||Change from Baseline: Nuc Tumor p-value||||1.000
72455090|NCT02095145|144433286|OTHER|||||||0.269|||||||Wilcoxon rank-sum test|||Change from Baseline: Cyt Benign p-value||||0.269
72455091|NCT02095145|144433286|OTHER|||||||0.066|||||||Wilcoxon rank-sum test|||Change from Baseline: Cyt Adjacent p-value||||0.066
72455092|NCT02095145|144433286|OTHER|||||||1|||||||Wilcoxon rank-sum test|||Change from Baseline: Cyt Tumor p-value||||1.000
72455093|NCT02095145|144433286|OTHER|||||||0.425|||||||Wilcoxon rank-sum test|||Change from Baseline: Cell Benign p-value||||0.425
72455094|NCT02095145|144433286|OTHER|||||||0.27|||||||Wilcoxon rank-sum test|||Change from Baseline: Cell Adjacent p-value||||0.270
72455095|NCT02095145|144433286|OTHER|||||||1|||||||Wilcoxon rank-sum test|||Change from Baseline: Cell Tumor p-value||||1.000
72455096|NCT02095145|144433287|OTHER|||||||0.625|||||||Wilcoxon rank-sum test|||Change From Baseline: Nuc Benign p-value||||0.625
72455097|NCT02095145|144433287|OTHER|||||||0.128|||||||Wilcoxon rank-sum test|||Change From Baseline: Nuc Adjacent p-value||||0.128
72455098|NCT02095145|144433287|OTHER|||||||0.045|||||||Wilcoxon rank-sum test|||Change From Baseline: Nuc Tumor p-value||||0.045
72455099|NCT02095145|144433287|OTHER|||||||0.105|||||||Wilcoxon rank-sum test|||Change From Baseline: Cyt Benign p-value||||0.105
72455100|NCT02095145|144433287|OTHER|||||||0.066|||||||Wilcoxon rank-sum test|||Change From Baseline: Cyt Adjacent p-value||||0.066
72455101|NCT02095145|144433287|OTHER|||||||0.005|||||||Wilcoxon rank-sum test|||Change From Baseline: Cyt Tumor p-value||||0.005
72455102|NCT02095145|144433287|OTHER|||||||0.129|||||||Wilcoxon rank-sum test|||Change From Baseline: Cell Benign p-value||||0.129
72455103|NCT02095145|144433287|OTHER|||||||0.066|||||||Wilcoxon rank-sum test|||Change From Baseline: Cell Adjacent p-value||||0.066
72455104|NCT02095145|144433287|OTHER|||||||0.013|||||||Wilcoxon rank-sum test|||Change From Baseline: Cell Tumor p-value||||0.013
72455105|NCT02095145|144433288|OTHER|||||||0.143|||||||Wilcoxon rank-sum test|||Change from Baseline: Benign p-value||||0.143
72455106|NCT02095145|144433288|OTHER|||||||0.037|||||||Wilcoxon rank-sum test|||Change from Baseline: Adjacent p-value||||0.037
72455107|NCT02095145|144433288|OTHER|||||||0.111|||||||Wilcoxon rank-sum test|||Change from Baseline: Tumor p-value||||0.111
72455108|NCT02095145|144433289|OTHER|||||||0.068|||||||Wilcoxon rank-sum test|||Change from Baseline Week 13||||0.068
72620475|NCT00289900|144772220|SUPERIORITY_OR_OTHER||Difference in Proportion|0.1||||0.134||95.0|-0.1|0.8|||Miettinen and Nurminen|||||0.8|-0.1|0.134
72620476|NCT00289900|144772221|SUPERIORITY_OR_OTHER||Difference in Percentage|0.1||||0.5625|TWO_SIDED|95.0|-0.3|0.9|||Miettinen and Nurminen|||||0.9|-0.3|0.5625
72620477|NCT00289900|144772222|SUPERIORITY_OR_OTHER||Difference in Percentage|0.7||||0.0233|TWO_SIDED|95.0|0.1|1.7|||Miettinen and Nurminen|||||1.7|0.1|0.0233
72620478|NCT00289900|144772223|SUPERIORITY_OR_OTHER||Difference in Percentage|-0.1||||0.7858|TWO_SIDED|95.0|-0.4|0.6|||Miettinen and Nurminen|||||0.6|-0.4|0.7858
72620479|NCT00289900|144772224|SUPERIORITY_OR_OTHER||Difference in Percentage|13.7|||||TWO_SIDED|95.0|9.4|18.0|||Miettinen and Nurminen|||||18.0|9.4|
72620480|NCT00289900|144772225|SUPERIORITY_OR_OTHER||Difference in Percentage|-0.7|||||TWO_SIDED|95.0|-2.6|1.4|||Miettinen and Nurminen|||||1.4|-2.6|
72620481|NCT00289900|144772226|SUPERIORITY_OR_OTHER||Difference in Percentage|11.7|||||TWO_SIDED|95.0|8.9|14.7|||Miettinen and Nurminen|||||14.7|8.9|
72620482|NCT00289900|144772227|SUPERIORITY_OR_OTHER||Difference in Percentage|-0.1|||||TWO_SIDED|95.0|-0.8|0.9|||Miettinen and Nurminen|||||0.9|-0.8|
72620483|NCT00289900|144772228|SUPERIORITY_OR_OTHER||Difference in Percentage|-0.1||||0.4997|TWO_SIDED|95.0|-0.4|0.5|||Miettinen and Nurminen|||||0.5|-0.4|0.4997
72455109|NCT02095145|144433289|OTHER|||||||0.004|||||||Wilcoxon rank-sum test|||Change from Baseline Week 26||||0.004
72455110|NCT02095145|144433289|OTHER|||||||0.002|||||||Wilcoxon rank-sum test|||Change from Baseline Week 39||||0.002
72455111|NCT02095145|144433289|OTHER||||||<|0.001|||||||Wilcoxon rank-sum test|||Change from Baseline Week 52||||<0.001
72455112|NCT02095145|144433290|OTHER|||||||1|||||||Wilcoxon rank-sum test|||Change from Baseline Week 13||||1.000
72455113|NCT02095145|144433290|OTHER|||||||0.18|||||||Wilcoxon rank-sum test|||Change from Baseline Week 26||||0.180
72455114|NCT02095145|144433290|OTHER|||||||0.62|||||||Wilcoxon rank-sum test|||Change from Baseline Week 39||||0.620
72455115|NCT02095145|144433290|OTHER|||||||0.536|||||||Wilcoxon rank-sum test|||Change from Baseline Week 52||||0.536
72455116|NCT02095145|144433292|OTHER|||||||0.231|||||||Wilcoxon rank-sum test|||Change in Tumor Volume from baseline to end of study per arm||||0.231
72455117|NCT00670488|144433297|OTHER||AUC0-48hr GMR|3.26||||||||||||||"The Last Day (Day 27)/Day 1 AUC 0-48 hr Geometric Mean Ratio (GMR) was calculated as follows: Last Day (Day 27) AUC 0-48hr Geometric Mean (GM) ÷ Day 1 AUC 0-48hr GM.~AUC 0-48hr GMR for last dose (Day 27) calculated using only data from participants who completed cycle one dosing as scheduled and had sufficient data for calculation."||||
72455118|NCT00670488|144433297|OTHER||AUC 0-48hr GMR|3.18||||||||||||||"The Last Day (Day 27)/Day 1 AUC 0-48 hr GMR was calculated as follows: Last Day (Day 27) AUC 0-48hr GM ÷ Day 1 AUC 0-48hr GM.~AUC 0-48hr GMR for last dose (Day 27) calculated using only data from participants who completed cycle one dosing as scheduled and had sufficient data for calculation."||||
72620484|NCT05486065|144772237|SUPERIORITY|The change in HbA1c from baseline was analysed using an ANCOVA (Analysis of Covariance) with randomised treatment and stratification factor, sex as fixed effect and baseline HbA1c as a covariate. Missing values were imputed using Jump to reference method.|Treatment difference|-0.82||||0.0002|TWO_SIDED|95.0|-1.25|-0.39|||ANCOVA|||||-0.39|-1.25|0.0002
72620485|NCT05486065|144772237|SUPERIORITY|The change in HbA1c from baseline was analysed using an ANCOVA (Analysis of Covariance) with randomised treatment and stratification factor, sex as fixed effect and baseline HbA1c as a covariate. Missing values were imputed using Jump to reference method.|Treatment difference|-0.77||||0.0003|TWO_SIDED|95.0|-1.19|-0.35|||ANCOVA|||||-0.35|-1.19|0.0003
72370385|NCT01708902|144251469|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001|TWO_SIDED|95.0|-1.23|-0.78|||ANCOVA||The adjusted mean difference was calculated as the adjusted mean of 'Main: Linagliptin 2.5mg / Metformin 1000mg BID' minus 'Main: Linagliptin 5mg QD'.|"The model includes treatment as a fixed effect and baseline HbA1c as a linear covariate.~The null and alternative hypotheses were tested in a hierarchical sequence. The next null hypothesis was tested in a confirmatory way only if all prior null-hypotheses were rejected. 'Greater effect' refers to a greater reduction in HbA1c."||-0.78|-1.23|<0.0001
72455119|NCT00670488|144433298|OTHER||Cmax GMR|2.59||||||||||||||"The Last Day (Day 27)/Day 1 Cmax GMR was calculated as follows: Last Day (Day 27) Cmax GM ÷ Day 1 Cmax GM.~Cmax GMR for last dose (Day 27) calculated using only data from participants who completed cycle one dosing as scheduled and had sufficient data for calculation."||||
72455120|NCT00670488|144433298|OTHER||Cmax GMR|2.67||||||||||||||"The Last Day (Day 27)/Day 1 Cmax GMR was calculated as follows: Last Day (Day 27) Cmax GM ÷ Day 1 Cmax GM.~Cmax GMR for last dose (Day 27) calculated using only data from participants who completed cycle one dosing as scheduled and had sufficient data for calculation."||||
72455121|NCT00670488|144433299|OTHER||C48hr GMR|4.33||||||||||||||"The Last Day (Day 27)/Day 1 C48hr GMR was calculated as follows: Last Day (Day 27) C48hr GM ÷ Day 1 C48hr GM.~C48hr GMR for last dose (Day 27) calculated using only data from participants who completed cycle one dosing as scheduled and had sufficient data for calculation."||||
72455122|NCT00670488|144433299|OTHER||C48hr GMR|3.58||||||||||||||"The Last Day (Day 27)/Day 1 C48hr GMR was calculated as follows: Last Day (Day 27) C48hr GM ÷ Day 1 C48hr GM.~C48hr GMR for last dose (Day 27) calculated using only data from participants who completed cycle one dosing as scheduled and had sufficient data for calculation."||||
72455123|NCT00670488|144433302|OTHER||AUC0-168hr GMR|1.91||||||||||||||The Last Day/Day 1 AUC 0-168 hr GMR was calculated as follows: Last Day AUC 0-168hr GM ÷ Day 1 AUC 0-48hr GM.||||
72455124|NCT00670488|144433302|OTHER||AUC 0-168hr GMR|1.54||||||||||||||The Last Day/Day 1 AUC 0-168 hr GMR was calculated as follows: Last Day AUC 0-168hr GM ÷ Day 1 AUC 0-48hr GM.||||
72455125|NCT00670488|144433303|OTHER||Cmax GMR|1.95||||||||||||||The Last Day/Day 1 Cmax GMR was calculated as follows: Last Day Cmax GM ÷ Day 1 Cmax GM.||||
72455126|NCT00670488|144433303|OTHER||Cmax GMR|1.33||||||||||||||The Last Day/Day 1 Cmax GMR was calculated as follows: Last Day Cmax GM ÷ Day 1 Cmax GM.||||
72455127|NCT00670488|144433304|OTHER||C48hr GMR|1.61||||||||||||||The Last Day/Day 1 C48hr GMR was calculated as follows: Last Day C48hr GM ÷ Day 1 C48hr GM.||||
72455128|NCT00670488|144433304|OTHER||C48hr GMR|1.86||||||||||||||The Last Day/Day 1 C48hr GMR was calculated as follows: Last Day C48hr GM ÷ Day 1 C48hr GM.||||
72455129|NCT00670488|144433304|OTHER||C48hr GMR|1.49||||||||||||||The Last Day/Day 1 C48hr GMR was calculated as follows: Last Day C48hr GM ÷ Day 1 C48hr GM.||||
72455130|NCT00670488|144433307|OTHER||GMR|0.133|||||TWO_SIDED|95.0|0.051|0.347||||||"pAkt Geometric Mean Ratio (GMR)~= Day 15 Geometric Mean (GM) ÷ Baseline GM"||0.347|0.051|
72455131|NCT01034306|144433330|SUPERIORITY|||||||0.0352||||||normal approximation to the binomial test|t-test, 2 sided|||||||0.0352
72455132|NCT01034306|144433331|SUPERIORITY|||||||0.2472|||||||t-test, 2 sided|||||||.2472
72455133|NCT01034306|144433332|SUPERIORITY|||||||0.1972|||||||t-test, 2 sided|||||||0.1972
72455134|NCT01619059|144433346|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.35|STANDARD_ERROR_OF_MEAN|0.087|<|0.0001|TWO_SIDED|95.0|-0.52|-0.18||Tested at alpha=0.05|Mixed Models Analysis|||||-0.18|-0.52|<0.0001
72455135|NCT01619059|144433347|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.9|STANDARD_ERROR_OF_MEAN|4.576||0.2014|TWO_SIDED|95.0|-14.9|3.1||Secondary endpoints were tested at alpha=0.05, applying the hierarchical order for the sequential testing procedure|Mixed Models Analysis|||||3.1|-14.9|0.2014
72455136|NCT01619059|144433348|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.7|STANDARD_ERROR_OF_MEAN|3.713|||TWO_SIDED|95.0|-11.0|3.6||||||||3.6|-11.0|
72620486|NCT05486065|144772237|SUPERIORITY|The change in HbA1c from baseline was analysed using an ANCOVA (Analysis of Covariance) with randomised treatment and stratification factor, sex as fixed effect and baseline HbA1c as a covariate. Missing values were imputed using Jump to reference method.|Treatment difference|-1.07|||<|0.0001|TWO_SIDED|95.0|-1.5|-0.64|||ANCOVA|||||-0.64|-1.50|<.0001
72455137|NCT01619059|144433349|SUPERIORITY_OR_OTHER||Risk Difference (RD)|12.2|STANDARD_ERROR_OF_MEAN|4.504|||TWO_SIDED|95.0|3.4|21.0||||||||21.0|3.4|
72620487|NCT05486065|144772237|OTHER||Treatment difference|0.05||||0.8305|TWO_SIDED|95.0|-0.38|0.47|||ANCOVA|||The change in HbA1c from baseline was analysed using an ANCOVA (Analysis of Covariance) with randomised treatment and stratification factor, sex as fixed effect and baseline HbA1c as a covariate. Missing values were imputed using Jump to reference method.||0.47|-0.38|0.8305
72455138|NCT03418545|144433350|SUPERIORITY||Percentage difference|67.5|||<|0.0001|TWO_SIDED|95.0|52.9|82.0||The p-value and 95% CI are computed by pooling 5 imputed datasets using PROC MIANALYZE in SAS with normal approximation. The p-value and 95% CI for each imputed data set is based on the Fisher's exact test and the Wald test, respectively.|Fisher Exact|||||82.0|52.9|<0.0001
72455139|NCT03418545|144433351|SUPERIORITY||Percentage difference|73.5|||||TWO_SIDED|95.0|60.2|86.8|||||The 95% CI is based on the Wald test.|||86.8|60.2|
72455140|NCT03418545|144433353|SUPERIORITY||||||<|0.0001||||||A 2-sided paired t-test at the 5% level was performed to demonstrate that the mean overall satisfaction score at Month 3 was statistically greater than that at Baseline for the treatment group.|t-test, 2 sided|||||||<0.0001
72455141|NCT01989793|144433377|EQUIVALENCE|Equivalence margin=0||||||0.97|||||||t-test, 2 sided|||Two-sample T-test of between-arm difference of change in isokinetic knee strength from baseline to week 8||||0.97
72455142|NCT01989793|144433378|EQUIVALENCE|Equivalence margin=0||||||0.48|||||||t-test, 2 sided|||Two-sample T-test of between-arm difference of change in isokinetic knee strength from baseline to week 16||||0.48
72455143|NCT01989793|144433379|EQUIVALENCE|Equivalence margin = 0||||||0.59|||||||t-test, 2 sided|||Two-sample T-test of between-arm difference of change in isokinetic knee strength from baseline to week 24||||0.59
72455144|NCT01989793|144433380|EQUIVALENCE|Equivalence margin=0||||||0.212|||||||t-test, 2 sided|assuming unequal variance between arms||Two-sample T-test of between-arm difference in fatiguability at week 8||||0.212
72455145|NCT01989793|144433381|EQUIVALENCE|Equivalence margin=0||||||0.271|||||||t-test, 2 sided|assuming unequal variance between arms||Two-sample T-test of between-arm difference in fatiguability at week 16||||0.271
72455146|NCT01989793|144433382|EQUIVALENCE|Equivalence margin=0||||||0.203|||||||t-test, 2 sided|assuming unequal variance between arms||Two-sample T-test of between-arm difference in fatiguability at week 24||||0.203
72455147|NCT01989793|144433383|EQUIVALENCE|Equivalence margin = 0||||||0.82|||||||Fisher Exact|||Fisher's exact test of percentage of participants with improvement in frailty score from baseline between treatment and placebo arms||||0.82
72455148|NCT01989793|144433384|EQUIVALENCE|Equivalence margin = 0||||||0.73|||||||Fisher Exact|||Fisher's exact test of percentage of participants with improvement in frailty score from baseline between treatment and placebo arms||||0.73
72455149|NCT01989793|144433385|EQUIVALENCE|Equivalence margin = 0||||||0.73|||||||Fisher Exact|||Fisher's exact test of percentage of participants with improvement in frailty score from baseline between treatment and placebo arms||||0.73
72455150|NCT02233998|144433402|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.234|STANDARD_ERROR_OF_MEAN|0.0162|<|0.001|TWO_SIDED|95.0|-0.266|-0.202||Per statistical analysis plan, Hochberg's method at significance level 0.05 was applied to jointly evaluate Whole Mouth Mean MGI at Wk 3 and Whole Mouth Mean PI at Wk 3 for both Listerine rinses vs control. Family-wise error controlled at 0.05.|ANCOVA|Terms included treatment with baseline whole mouth mean modified gingival index as a covariate.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-0.202|-0.266|<0.001
72455151|NCT02233998|144433402|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.197|STANDARD_ERROR_OF_MEAN|0.0161|<|0.001|TWO_SIDED|95.0|-0.228|-0.165||Per statistical analysis plan, Hochberg's method at significance level 0.05 was applied to jointly evaluate Whole Mouth Mean MGI at Wk 3 and Whole Mouth Mean PI at Wk 3 for both Listerine rinses vs control. Family-wise error controlled at 0.05.|ANCOVA|Terms included treatment with baseline whole mouth mean modified gingival index as a covariate.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-0.165|-0.228|<0.001
72455152|NCT02233998|144433403|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.469|STANDARD_ERROR_OF_MEAN|0.0286|<|0.001|TWO_SIDED|95.0|-0.526|-0.413||Per statistical analysis plan, Hochberg's method at significance level 0.05 was applied to jointly evaluate Whole Mouth Mean MGI at Wk 3 and Whole Mouth Mean PI at Wk 3 for both Listerine rinses vs control. Family-wise error controlled at 0.05.|ANCOVA|Terms included treatment with baseline whole mouth mean plaque index as a covariate.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-0.413|-0.526|<0.001
72455153|NCT02233998|144433403|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.379|STANDARD_ERROR_OF_MEAN|0.0286|<|0.001|TWO_SIDED|95.0|-0.435|-0.322||Per statistical analysis plan, Hochberg's method at significance level 0.05 was applied to jointly evaluate Whole Mouth Mean MGI at Wk 3 and Whole Mouth Mean PI at Wk 3 for both Listerine rinses vs control. Family-wise error controlled at 0.05.|ANCOVA|Terms included treatment with baseline whole mouth mean plaque index as a covariate.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-0.322|-0.435|<0.001
72455154|NCT02233998|144433404|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.006|<|0.001|TWO_SIDED|95.0|-0.042|-0.019||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment with baseline whole mouth mean gingival bleeding index as a covariate.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-0.019|-0.042|<0.001
72455155|NCT02233998|144433404|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.026|STANDARD_ERROR_OF_MEAN|0.0059|<|0.001|TWO_SIDED|95.0|-0.038|-0.014||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment with baseline whole mouth mean gingival bleeding index as a covariate.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-0.014|-0.038|<0.001
72620488|NCT05486065|144772237|OTHER|The change in HbA1c from baseline was analysed using an ANCOVA (Analysis of Covariance) with randomised treatment and stratification factor, sex as fixed effect and baseline HbA1c as a covariate. Missing values were imputed using Jump to reference method.|Treatment difference|-0.3||||0.1678|TWO_SIDED|95.0|-0.72|0.13|||ANCOVA|||||0.13|-0.72|0.1678
72562782|NCT01976728|144657346|SUPERIORITY|||||||0.3173||||||The p-value was based on the stratified (by randomization scheme) Wilcoxon rank sum test.|Wilcoxon rank sum test|SAS PROC FREQ with modified ridit score (MODRIDIT option) was used for the stratified Wilcoxon rank sum test.||Day 21: Number of follicles with a mean diameter ≥18 mm in the LutrePulse 10 μg group was compared to placebo, using Wilcoxon's rank sum test.||||0.3173
72562783|NCT01976728|144657346|SUPERIORITY|||||||0.3778||||||The p-value was based on the Wilcoxon rank sum test without stratification.|Wilcoxon rank sum test|SAS PROC FREQ with modified ridit score (MODRIDIT option) was used for the stratified Wilcoxon rank sum test.||Day 21: Number of follicles with a mean diameter ≥18 mm in the LutrePulse 15 μg group was compared to placebo, using Wilcoxon's rank sum test.||||0.3778
72562784|NCT01976728|144657347|SUPERIORITY||Least square mean (LSM) difference|1.35||||0.6732|TWO_SIDED|95.0|-5.16|7.87||p-value for the LutrePulse 10 µg group compared to placebo based on the fitted linear model were reported.|ANCOVA|PROC GLM was used for ANCOVA.|The LSM difference on the treatment groups and 95% confidence interval (CI) for the LutrePulse 10 µg group compared to placebo based on the fitted linear model were reported. Type III sum-of-squares for the LSMs were used for statistical comparisons.|Maximum P4 levels in the LutrePulse 10 µg group were compared to placebo using an analysis of covariance (ANCOVA) model including the randomization scheme and treatment group as factors and baseline value as covariate.||7.87|-5.16|0.6732
72562785|NCT01976728|144657347|SUPERIORITY||LSM|5.7||||0.0814|TWO_SIDED|95.0|-0.76|12.15||p-value for the LutrePulse 15 µg group compared to placebo based on the fitted linear model were reported.|ANCOVA|PROC GLM was used for ANCOVA.|The LSM difference on the treatment groups and 95% CI for the LutrePulse 15 µg group compared to placebo based on the fitted linear model were reported. Type III sum-of-squares for the LSMs were used for statistical comparisons.|Maximum P4 levels in the LutrePulse 15 µg group were compared to placebo using an ANCOVA model including treatment group as factors and baseline value as covariate.||12.15|-0.76|0.0814
72620489|NCT05486065|144772237|OTHER|The change in HbA1c from baseline was analysed using an ANCOVA (Analysis of Covariance) with randomised treatment and stratification factor, sex as fixed effect and baseline HbA1c as a covariate. Missing values were imputed using Jump to reference method.|Treatment difference|-0.25||||0.2445|TWO_SIDED|95.0|-0.67|0.17|||ANCOVA|||||0.17|-0.67|0.2445
72620490|NCT02656173|144772241|SUPERIORITY||least square mean difference|-0.52|||<|0.001|TWO_SIDED|95.0|-0.82|-0.21|||ANCOVA|||Analysis of Covariance (ANCOVA) was used for analysis, including treatment group and region as fixed factors and baseline as a covariate.||-0.21|-0.82|<0.001
72620491|NCT02656173|144772242|SUPERIORITY||least square mean difference|-0.48|||<|0.001|TWO_SIDED|95.0|-0.78|-0.17|||mixed model repeated measure|||Mixed Model Repeated Measure (MMRM) was used for analysis, which included the baseline as a covariate, treatment group, analysis visits and region as a fixed effect, subject as random effect and including interaction of \[treatment group x visit\] for FAS.||-0.17|-0.78|<0.001
72620492|NCT02656173|144772243|SUPERIORITY||least square mean difference|-0.28||||0.112|TWO_SIDED|95.0|-0.63|0.07|||ANCOVA|||Analysis of Covariance (ANCOVA) was used for analysis including treatment group and region as fixed factors and baseline as a covariate.||0.07|-0.63|0.112
72620493|NCT02656173|144772244|SUPERIORITY||Cochran-Mantel-Haenszel Statistics|1.75||||0.186|||||||Stratified Rank Analysis of Covariance|||Stratified Rank Analysis of Covariance (RANCOVA), including the rank score for change from Baseline to End of Treatment stratified by region as the dependent variable, treatment group and region as fixed factors and the rank score for baseline stratified by region as a covariate for FAS.||||0.186
72455156|NCT02233998|144433405|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimate of difference|23.24|||<|0.001|TWO_SIDED|95.0|20.75|25.85||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|Wilcoxon Rank Sum Test|P-values were based on Wilcoxon Rank Sum Test on the change from baseline.|95% Confidence limits for the location shift.|The null hypothesis was no difference between treatment groups. The alternative hypothesis was a difference between treatment groups.||25.85|20.75|<0.001
72455157|NCT02233998|144433405|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimate of difference|19.444|||<|0.001|TWO_SIDED|95.0|17.09|22.22||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|Wilcoxon Rank Sum Test|P-values were based on Wilcoxon Rank Sum Test on the change from baseline.|95% Confidence limits for the location shift.|The null hypothesis was no difference between treatment groups. The alternative hypothesis was a difference between treatment groups.||22.22|17.09|<0.001
72620494|NCT02656173|144772245|SUPERIORITY||Cochran-Mantel-Haenszel Statistics|0.09||||0.76|||||||Stratified Rank Analysis of Covariance|||Stratified Rank Analysis of Covariance (RANCOVA), including the rank score for change from Baseline to End of Treatment stratified by region as the dependent variable, treatment group and region as fixed factors and the rank score for baseline stratified by region as a covariate for FAS.||||0.760
72620495|NCT02656173|144772246|SUPERIORITY||Least square mean difference|-0.03||||0.646|TWO_SIDED|95.0|-0.18|0.11|||ANCOVA|||Analysis of Covariance (ANCOVA) was used for analysis including treatment group and region as fixed factors and baseline as a covariate.||0.11|-0.18|0.646
72620496|NCT02656173|144772247|SUPERIORITY||Least square mean difference|12.08|||<|0.001|TWO_SIDED|95.0|6.33|17.84|||ANCOVA|||Analysis of Covariance (ANCOVA) was used for analysis including treatment group and region as fixed factors and baseline as a covariate.||17.84|6.33|<0.001
72620497|NCT02656173|144772248|SUPERIORITY||Least square mean difference|-0.65||||0.001|TWO_SIDED|95.0|-1.04|-0.26|||ANCOVA|||Analysis of Covariance (ANCOVA) was used for analysis including treatment group and region as fixed factors and baseline as a covariate.||-0.26|-1.04|0.001
72455158|NCT02233998|144433406|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimate of difference|19.048|||<|0.001|TWO_SIDED|95.0|15.94|21.73||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|Wilcoxon Rank Sum Test|P-values were based on Wilcoxon Rank Sum Test on the change from baseline.|95% Confidence limits for the location shift.|The null hypothesis was no difference between treatment groups. The alternative hypothesis was a difference between treatment groups.||21.73|15.94|<0.001
72620498|NCT02656173|144772249|SUPERIORITY||Least square mean difference|-0.11||||0.006|TWO_SIDED|95.0|-0.19|-0.03|||ANCOVA|||Subscale: Daytime Frequency. Analysis of Covariance (ANCOVA) was used for analysis including treatment group and region as fixed factors and baseline as a covariate.||-0.03|-0.19|0.006
72620499|NCT02656173|144772249|SUPERIORITY||Least square mean difference|-0.08||||0.174|TWO_SIDED|95.0|-0.19|0.03|||ANCOVA|||Subscale: Nighttime Frequency. ANCOVA was used for analysis including treatment group and region as fixed factors and baseline as a covariate.||0.03|-0.19|0.174
72620500|NCT02656173|144772249|SUPERIORITY||Least square mean difference|-0.26||||0.037|TWO_SIDED|95.0|-0.5|-0.02|||ANCOVA|||Subscale: Urgency. ANCOVA was used for analysis including treatment group and region as fixed factors and baseline as a covariate.||-0.02|-0.50|0.037
72620501|NCT02656173|144772249|SUPERIORITY||Least square mean difference|-0.18||||0.014|TWO_SIDED|95.0|-0.32|-0.04|||ANCOVA|||Subscale: Urgency Incontinence. ANCOVA was used for analysis including treatment group and region as fixed factors and baseline as a covariate.||-0.04|-0.32|0.014
72391854|NCT00256750|144290857|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|-0.02|||<|0.0001|TWO_SIDED|95.0|-0.029|-0.012||Missing data were imputed by LOCF. The ridit of the reference group is by definition 0.5.|z-test|The obtained ridits between treatment groups will be compared using z-test at 0.05 significance level for each year.||Symptom Distress, Month 12. For calculation of symptom distress, those symptoms that never occurred will be converted to missing values, in order to avoid anticipatory symptom distress.||-0.012|-0.029|<0.0001
72620502|NCT02656173|144772250|SUPERIORITY||Least square mean difference|-1.19||||0.002|TWO_SIDED|95.0|-1.94|-0.44|||ANCOVA|||Analysis of Covariance (ANCOVA) was used for analysis including treatment group and region as fixed factors and baseline as a covariate.||-0.44|-1.94|0.002
72391855|NCT00256750|144290857|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|-0.026|||<|0.0001|TWO_SIDED|95.0|-0.034|-0.017||Missing data were imputed by LOCF. The ridit of the reference group is by definition 0.5.|z-test|The obtained ridits between treatment groups will be compared using z-test at 0.05 significance level for each year.||Symptom Occurrence, Month 12.||-0.017|-0.034|<0.0001
72391856|NCT00256750|144290857|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|-0.025|||<|0.0001|TWO_SIDED|95.0|-0.034|-0.016||Missing data were imputed by LOCF. The ridit of the reference group is by definition 0.5.|z-test|The obtained ridits between treatment groups will be compared using z-test at 0.05 significance level for each year.||Symptom Occurrence, Month 12.||-0.016|-0.034|<0.0001
72391857|NCT00256750|144290857|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|-0.021|||<|0.0001|TWO_SIDED|95.0|-0.03|-0.013||Missing data were imputed by LOCF. The ridit of the reference group is by definition 0.5.|z-test|The obtained ridits between treatment groups will be compared using z-test at 0.05 significance level for each year.||Symptom Distress, Month 24. For calculation of symptom distress, those symptoms that never occurred will be converted to missing values, in order to avoid anticipatory symptom distress.||-0.013|-0.030|<0.0001
72391858|NCT00256750|144290857|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|-0.015|||<|0.0001|TWO_SIDED|95.0|-0.024|-0.007||Missing data were imputed by LOCF. The ridit of the reference group is by definition 0.5.|z-test|The obtained ridits between treatment groups will be compared using z-test at 0.05 significance level for each year.||Symptom Distress, Month 24. For calculation of symptom distress, those symptoms that never occurred will be converted to missing values, in order to avoid anticipatory symptom distress.||-0.007|-0.024|<0.0001
72391859|NCT00256750|144290857|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|-0.023|||<|0.0001|TWO_SIDED|95.0|-0.031|-0.015||Missing data were imputed by LOCF. The ridit of the reference group is by definition 0.5.|z-test|The obtained ridits between treatment groups will be compared using z-test at 0.05 significance level for each year.||Symptom Occurrence, Month 24||-0.015|-0.031|<0.0001
72391860|NCT00256750|144290857|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|-0.021|||<|0.0001|TWO_SIDED|95.0|-0.03|-0.013||Missing data were imputed by LOCF. The ridit of the reference group is by definition 0.5.|z-test|The obtained ridits between treatment groups will be compared using z-test at 0.05 significance level for each year.||Symptom Occurrence, Month 24||-0.013|-0.030|<0.0001
72391861|NCT00256750|144290858|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|0.8||||0.4498|TWO_SIDED|95.0|-1.2|2.7|||ANCOVA|Adjusted mean based on an ANCOVA model with treatment as factor, and baseline value as covariate.|Statistical tests comparing each belatacept regimen to the CsA regimen were conducted at a significance level of 0.05. Subjects with only baseline observations were excluded from these summaries.|Mental Component Score; Month 6||2.7|-1.2|0.4498
72620503|NCT02656173|144772251|SUPERIORITY||Least square mean difference|-0.78|||<|0.001|TWO_SIDED|95.0|-1.13|-0.43|||ANCOVA|||Subscale: Storage Subscale. Analysis of Covariance (ANCOVA) was used for analysis including treatment group and region as fixed factors and baseline as a covariate.||-0.43|-1.13|<0.001
72620504|NCT02656173|144772251|SUPERIORITY||Least square mean difference|-0.3||||0.167|TWO_SIDED|95.0|-0.72|0.13|||ANCOVA|||Subscale: Voiding Subscale-1. ANCOVA was used for analysis including treatment group and region as fixed factors and baseline as a covariate.||0.13|-0.72|0.167
72391862|NCT00256750|144290858|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|1.9||||0.0584|TWO_SIDED|95.0|-0.1|3.9|||ANCOVA|Adjusted mean based on an ANCOVA model with treatment as factor, and baseline value as covariate.|Statistical tests comparing each belatacept regimen to the CsA regimen were conducted at a significance level of 0.05. Subjects with only baseline observations were excluded from these summaries.|Mental Component Score; Month 6||3.9|-0.1|0.0584
72391863|NCT00256750|144290858|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|1.1||||0.1595|TWO_SIDED|95.0|-0.5|2.7|||ANCOVA|Adjusted mean based on an ANCOVA model with treatment as factor, and baseline value as covariate.|Statistical tests comparing each belatacept regimen to the CsA regimen were conducted at a significance level of 0.05. Subjects with only baseline observations were excluded from these summaries.|Physical Component Score; Month 6||2.7|-0.5|0.1595
72391864|NCT00256750|144290858|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|1.7||||0.0457|TWO_SIDED|95.0|0.0|3.3|||ANCOVA|Adjusted mean based on an ANCOVA model with treatment as factor, and baseline value as covariate.|Statistical tests comparing each belatacept regimen to the CsA regimen were conducted at a significance level of 0.05. Subjects with only baseline observations were excluded from these summaries.|Physical Component Score; Month 6||3.3|0.0|0.0457
72391865|NCT00256750|144290858|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|1.3||||0.1729|TWO_SIDED|95.0|-0.6|3.2|||ANCOVA|Adjusted mean based on an ANCOVA model with treatment as factor, and baseline value as covariate.|Statistical tests comparing each belatacept regimen to the CsA regimen were conducted at a significance level of 0.05. Subjects with only baseline observations were excluded from these summaries.|Mental Component Score; Month 12||3.2|-0.6|0.1729
72620505|NCT02656173|144772251|SUPERIORITY||Least square mean difference|-0.42||||0.103|TWO_SIDED|95.0|-0.93|0.09|||ANCOVA|||Subscale: Voiding Subscale-2. ANCOVA was used for analysis including treatment group and region as fixed factors and baseline as a covariate.||0.09|-0.93|0.103
72455159|NCT02233998|144433406|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimate of difference|15.939|||<|0.001|TWO_SIDED|95.0|12.5|18.67||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|Wilcoxon Rank Sum Test|P-values were based on Wilcoxon Rank Sum Test on the change from baseline.|95% Confidence limits for the location shift.|The null hypothesis was no difference between treatment groups. The alternative hypothesis was a difference between treatment groups.||18.67|12.50|<0.001
72455160|NCT02233998|144433407|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimate of difference|2.05|||<|0.001|TWO_SIDED|95.0|1.3|2.78||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|Wilcoxon Rank Sum Test|P-values were based on Wilcoxon Rank Sum Test on the change from baseline.|95% Confidence limits for the location shift.|The null hypothesis was no difference between treatment groups. The alternative hypothesis was a difference between treatment groups.||2.78|1.30|<0.001
72455161|NCT02233998|144433407|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimate of difference|1.19|||<|0.001|TWO_SIDED|95.0|0.93|2.06||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|Wilcoxon Rank Sum Test|P-values were based on Wilcoxon Rank Sum Test on the change from baseline.|95% Confidence limits for the location shift.|The null hypothesis was no difference between treatment groups. The alternative hypothesis was a difference between treatment groups.||2.06|0.93|<0.001
72455162|NCT02233998|144433408|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimate of difference|1.316||||0.016|TWO_SIDED|95.0|0.0|2.78||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|Wilcoxon Rank Sum Test|P-values were based on Wilcoxon Rank Sum Test on the change from baseline.|95% Confidence limits for the location shift.|The null hypothesis was no difference between treatment groups. The alternative hypothesis was a difference between treatment groups.||2.78|0.00|0.016
72455163|NCT02233998|144433408|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimate of difference|0.926||||0.197|TWO_SIDED|95.0|-0.16|1.85||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|Wilcoxon Rank Sum Test|P-values were based on Wilcoxon Rank Sum Test on the change from baseline.|95% Confidence limits for the location shift.|The null hypothesis was no difference between treatment groups. The alternative hypothesis was a difference between treatment groups.||1.85|-0.16|0.197
72455164|NCT02233998|144433409|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimate of difference|23.214|||<|0.001|TWO_SIDED|95.0|18.21|28.77||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|Wilcoxon Rank Sum Test|P-values were based on Wilcoxon Rank Sum Test on the change from baseline.|95% Confidence limits for the location shift.|The null hypothesis was no difference between treatment groups. The alternative hypothesis was a difference between treatment groups.||28.77|18.21|<0.001
72455165|NCT02233998|144433409|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimate of difference|18.59|||<|0.001|TWO_SIDED|95.0|13.69|23.81||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|Wilcoxon Rank Sum Test|P-values were based on Wilcoxon Rank Sum Test on the change from baseline.|95% Confidence limits for the location shift.|The null hypothesis was no difference between treatment groups. The alternative hypothesis was a difference between treatment groups.||23.81|13.69|<0.001
72455166|NCT02233998|144433410|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimate of difference|19.048|||<|0.001|TWO_SIDED|95.0|15.94|21.73||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|Wilcoxon Rank Sum Test|P-values were based on Wilcoxon Rank Sum Test on the change from baseline.|95% Confidence limits for the location shift.|The null hypothesis was no difference between treatment groups. The alternative hypothesis was a difference between treatment groups.||21.73|15.94|<0.001
72499891|NCT00190775|144530098|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.78|STANDARD_ERROR_OF_MEAN|1.11|<|0.001||95.0|||||Mixed Models Analysis|Model included visit, baseline, treatment, pooled investigator, child with ADHD, and treatment by visit.|Least Squares Mean Difference = Atomoxetine - Placebo.|Approximately 500 participants were randomized to atomoxetine or placebo (1:1) which provided at least 90% power to detect a treatment difference of 3.64 points on the CAARS-Inv:SV Total ADHD Symptoms Score assuming a SD of 9.85 based on 2-sided significance level of 0.05 using a 2-sample t-test. Mean and SD assumptions were associated with effect size of 0.37 and 30% missing data rate. These assumptions applied to Weeks 12 and 24 treatment effects. Marginal power at Weeks 12 and 24 was 86%.||||<0.001
72499892|NCT00190775|144530099|SUPERIORITY_OR_OTHER|||||||0.905||95.0||||P-Value for Task Accomplishment.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.905
72499893|NCT00190775|144530099|SUPERIORITY_OR_OTHER|||||||0.491||95.0||||P-Value for Role Performance.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.491
72499894|NCT00190775|144530099|SUPERIORITY_OR_OTHER|||||||0.6||95.0||||P-Value for Communication.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.600
72499895|NCT00190775|144530099|SUPERIORITY_OR_OTHER|||||||0.052||95.0||||P-Value for Affective Expression.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.052
72499896|NCT00190775|144530099|SUPERIORITY_OR_OTHER|||||||0.514||95.0||||P-Value for Involvement.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.514
72499897|NCT00190775|144530099|SUPERIORITY_OR_OTHER|||||||0.515||95.0||||P-Value for Control.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.515
72499898|NCT00190775|144530099|SUPERIORITY_OR_OTHER|||||||0.315||95.0||||P-Value for Values and Norms.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.315
72499899|NCT00190775|144530100|SUPERIORITY_OR_OTHER|||||||0.176||95.0||||P-Value for Task Accomplishment.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.176
72499900|NCT00190775|144530100|SUPERIORITY_OR_OTHER|||||||0.122||95.0||||P-Value for Role Performance.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.122
72499901|NCT00190775|144530100|SUPERIORITY_OR_OTHER|||||||0.931||95.0||||P-Value for Communication.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.931
72499902|NCT00190775|144530100|SUPERIORITY_OR_OTHER|||||||0.788||95.0||||P-Value for Affective Expression.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.788
72499903|NCT00190775|144530100|SUPERIORITY_OR_OTHER|||||||0.19||95.0||||P-Value for Involvement.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.190
72455167|NCT02233998|144433410|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimate of difference|15.939|||<|0.001|TWO_SIDED|95.0|12.5|18.67||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|Wilcoxon Rank Sum Test|P-values were based on Wilcoxon Rank Sum Test on the change from baseline.|95% Confidence limits for the location shift.|The null hypothesis was no difference between treatment groups. The alternative hypothesis was a difference between treatment groups.||18.67|12.50|<0.001
72455168|NCT01957163|144433411|SUPERIORITY_OR_OTHER||Least squared mean difference|0.124|||<|0.001|TWO_SIDED|95.0|0.093|0.154|||Mixed Model Repeated Measure|Restricted maximum likelihood (REM) - based repeated measure approach (MMRM)||||0.154|0.093|< 0.001
72455169|NCT01957163|144433411|SUPERIORITY_OR_OTHER||Least squared mean difference|0.128|||<|0.001|TWO_SIDED|95.0|0.098|0.159|||Mixed Model Repeated Measure|Restricted maximum likelihood (REM) - based repeated measure approach (MMRM)||||0.159|0.098|<0.001
72455170|NCT01957163|144433412|SUPERIORITY_OR_OTHER||Least squared mean difference|0.153|||<|0.001|TWO_SIDED|95.0|0.118|0.187|||Mixed Model Repeated Measure|Restricted maximum likelihood (REM) - based repeated measure approach (MMRM)||||0.187|0.118|<0.001
72455171|NCT01957163|144433412|SUPERIORITY_OR_OTHER||Least squared mean difference|0.14|||<|0.001|TWO_SIDED|95.0|0.106|0.175|||Mixed Model Repeated Measure|Restricted maximum likelihood (REM) - based repeated measure approach (MMRM)||||0.175|0.106|<0.001
72455172|NCT03697603|144433439|SUPERIORITY||Mean Difference (Final Values)|-1.4||||0.0312|TWO_SIDED|95.0|-2.7|-0.1|||MMRM|||Statistical analysis to compare brexpiprazole 2 mg/day and placebo was performed at Week 6.||-0.1|-2.7|0.0312
72455173|NCT03697603|144433439|SUPERIORITY||Mean Difference (Final Values)|-1.7||||0.0089|TWO_SIDED|95.0|-3.0|-0.4|||MMRM|||Statistical analysis to compare brexpiprazole 1 mg/day and placebo was performed at Week 6.||-0.4|-3.0|0.0089
72455174|NCT03697603|144433440|OTHER||Diff|5.5||||0.1964|TWO_SIDED|95.0|-2.8|13.8|||Chi-squared|||Statistical analysis to compare brexpiprazole 2 mg/day and placebo was performed at Week 6.||13.8|-2.8|0.1964
72455175|NCT03697603|144433440|OTHER||Diff|5.5||||0.1969|TWO_SIDED|95.0|-2.8|13.7|||Chi-squared|||Statistical analysis to compare brexpiprazole 1 mg/day and placebo was performed at Week 6.||13.7|-2.8|0.1969
72455176|NCT02686658|144433441|OTHER|Model for repeated measures (MRM) and square root transformation was used to compare the treatment groups.|Least Squares Mean Difference|0.11||||0.0072|TWO_SIDED|95.0|||||Model for repeated measures (MRM)|||Difference in least squares means between groups calculated as (Sham) minus (Zimura).||||0.0072
72455177|NCT02686658|144433441|OTHER|Model for repeated measures (MRM) and square root transformation was used to compare treatment groups.|Least Squares Mean Difference|0.124||||0.0051|TWO_SIDED|95.0|||||Model for repeated measures (MRM)|||Difference in least squares means between groups calculated as (Sham) minus (Zimura).||||0.0051
72455178|NCT02686658|144433442|OTHER|Model for repeated measures (MRM) was used to compare the treatment groups.|Least Squares Mean Difference|1.39||||0.3464|TWO_SIDED||||||Model for repeated measures (MRM)|||Difference in least squares mean between groups calculated as (Zimura) minus (Sham).||||0.3464
72455179|NCT02686658|144433442|OTHER|Model for repeated measures (MRM) was used to compare the treatment groups.|Least Squares Mean Difference|-0.28||||0.883|TWO_SIDED||||||Model for repeated measures (MRM)|||Difference in least squares mean between groups calculated as (Zimura) minus (Sham).||||0.8830
72499904|NCT00190775|144530100|SUPERIORITY_OR_OTHER|||||||0.36||95.0||||P-Value for Control.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.360
72499905|NCT00190775|144530100|SUPERIORITY_OR_OTHER|||||||0.446||95.0||||P-Value for Values and Norms.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.446
72455180|NCT02686658|144433443|OTHER|Model for repeated measures (MRM) was used to compare the treatment groups.|Least Squares Mean Difference|0.38||||0.8405|TWO_SIDED||||||Model for repeated measures (MRM)|||Difference in least squares mean between groups calculated as (Zimura) minus (Sham).||||0.8405
72455181|NCT02686658|144433443|OTHER|Model for repeated measures (MRM) was used to compare the treatment groups.|Least Squares Mean Difference|-1.44||||0.5017|TWO_SIDED||||||Model for repeated measures (MRM)|||Difference in least squares mean between groups calculated as (Zimura) minus (Sham).||||0.5017
72455182|NCT02222493|144433500|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence test|Proportion Difference|-2.39|||||TWO_SIDED|95.0|-9.92|5.11||||||Score statistic method||5.11|-9.92|
72455183|NCT02222493|144433500|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence test|Proportion Difference|-2.39|||||TWO_SIDED|90.0|-8.75|4.02||||||Score statistic method||4.02|-8.75|
72455184|NCT03924869|144433540|SUPERIORITY||Hazard Ratio (HR)|0.92||||0.2932|TWO_SIDED|95.0|0.69|1.24||1-sided p-value based on log-rank test stratified by Disease Stage, ECOG Performance Status, Geographic Region of Enrollment Site, and Reason For Not Receiving Surgery.|Log Rank|||"Hazard ratio and 95% confidence intervals (CIs) were based on Cox regression model with Efron's method of tie handling with treatment as a covariate, stratified by Disease Stage (Stage I versus Stage II), ECOG Performance Status (0 or 1 versus 2), Geographic Region of Enrollment Site (East Asia versus non-East Asia), and Reason For Not Receiving Surgery (medically inoperable versus refused surgery)."||1.24|0.69|0.29320
72455185|NCT03924869|144433541|OTHER||Hazard Ratio (HR)|1.33||||0.93971|TWO_SIDED|95.0|0.93|1.9||1-sided p-value based on log-rank test stratified by Disease Stage, ECOG Performance Status, Geographic Region of Enrollment Site, and Reason For Not Receiving Surgery.|Log Rank|Per protocol, since the EFS null hypothesis was not rejected, the OS hypothesis was not formally tested and the p-value should be considered nominal.||"Hazard ratio and 95% CIs were based on Cox regression model with Efron's method of tie handling with treatment as a covariate, stratified by Disease Stage (Stage I versus Stage II), ECOG Performance Status (0 or 1 versus 2), Geographic Region of Enrollment Site (East Asia versus non-East Asia), and Reason for Not Receiving Surgery (medically inoperable versus refused surgery)."||1.90|0.93|0.93971
72499906|NCT00190775|144530101|SUPERIORITY_OR_OTHER|||||||0.575||95.0||||P-Value for Task Accomplishment.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.575
72499907|NCT00190775|144530101|SUPERIORITY_OR_OTHER|||||||0.705||95.0||||P-Value for Role Performance.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.705
72499908|NCT00190775|144530101|SUPERIORITY_OR_OTHER|||||||0.686||95.0||||P-Value for Communication.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.686
72499909|NCT00190775|144530101|SUPERIORITY_OR_OTHER|||||||0.618||95.0||||P-Value for Affective Expression.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.618
72455186|NCT03924869|144433542|OTHER||Hazard Ratio (HR)|1.02|||||TWO_SIDED|95.0|0.74|1.42||Per protocol, there was no hypothesis pre-specified for TDDM to be formally tested.||||"Hazard ratio and 95% CIs were based on Cox regression model with Efron's method of tie handling with treatment as a covariate, stratified by Disease Stage (Stage I versus Stage II), ECOG Performance Status (0 or 1 versus 2), Geographic Region of Enrollment Site (East Asia versus non-East Asia), and Reason for Not Receiving Surgery (medically inoperable versus refused surgery)."||1.42|0.74|
72455187|NCT03924869|144433545|OTHER||Mean Difference (Final Values)|-1.21||||0.5187|TWO_SIDED|95.0|-4.9|2.48|||cLDA model|||"Stats:~LS Mean change and 95% CIs were based on a constrained longitudinal data analysis (cLDA) model with the EORTC QLQ-C30 scores as the response variable with covariates for treatment by study visit interaction, and stratification factors by Disease Stage (Stage I versus Stage II), ECOG Performance Status (0 or 1 versus 2), Geographic Region of Enrollment Site (East Asia versus non-East Asia), and Reason For Not Receiving Surgery (medically inoperable versus refused surgery)."||2.48|-4.90|0.5187
72455188|NCT03924869|144433546|OTHER||Mean Difference (Final Values)|-4.34||||0.0906|TWO_SIDED|95.0|-9.38|0.69|||cLDA model|||LS Mean change and 95% CIs were based on a cLDA model with the EORTC QLQ-LC13 scores as the response variable with covariates for treatment by study visit interaction, and stratification factors by Disease Stage (Stage I versus Stage II), ECOG Performance Status (0 or 1 versus 2), Geographic Region of Enrollment Site (East Asia versus non-East Asia), and Reason For Not Receiving Surgery (medically inoperable versus refused surgery).||0.69|-9.38|0.0906
72562786|NCT01976728|144657347|SUPERIORITY||LSM difference|7.55||||0.0223|TWO_SIDED|95.0|1.16|13.93||p-value for the LutrePulse 20 µg group compared to placebo based on the fitted linear model were reported.|ANCOVA|PROC GLM was used for ANCOVA.|The LSM difference on the treatment groups and 95% CI for the LutrePulse 20 µg group compared to placebo based on the fitted linear model were reported. Type III sum-of-squares for the LSMs were used for statistical comparisons.|Maximum P4 levels in the LutrePulse 20 µg group were compared to placebo using an ANCOVA model including the randomization scheme and treatment group as factors and baseline value as covariate.||13.93|1.16|0.0223
72562787|NCT01976728|144657348|SUPERIORITY||LSM difference|0.679||||0.7355|TWO_SIDED|95.0|-3.404|4.762||p-value for the LutrePulse 10 µg group compared to placebo based on the fitted linear model were reported.|ANCOVA|PROC GLM was used for ANCOVA.|The LSM difference on the treatment groups and 95% CI for the LutrePulse 10 µg group compared to placebo based on the fitted linear model were reported. Type III sum-of-squares for the LSMs were used for statistical comparisons.|Mean P4 levels in the LutrePulse 10 µg group were compared to placebo using an ANCOVA model including the randomization scheme and treatment group as factors and baseline value as covariate.||4.762|-3.404|0.7355
72562788|NCT01976728|144657348|SUPERIORITY||LSM difference|2.602||||0.198|TWO_SIDED|95.0|-1.444|6.648||p-value for the LutrePulse 15 µg group compared to placebo based on the fitted linear model were reported.|ANCOVA|PROC GLM was used for ANCOVA.|The LSM difference on the treatment groups and 95% CI for the LutrePulse 15 µg group compared to placebo based on the fitted linear model were reported. Type III sum-of-squares for the LSMs were used for statistical comparisons.|Mean P4 levels in the LutrePulse 15 µg group were compared to placebo using an ANCOVA model including treatment group as factors and baseline value as covariate.||6.648|-1.444|0.1980
72562789|NCT01976728|144657348|SUPERIORITY||LSM difference|4.88||||0.0187|TWO_SIDED|95.0|0.878|8.882||p-value for the LutrePulse 10 µg group compared to placebo based on the fitted linear model were reported.|ANCOVA|PROC GLM was used for ANCOVA.|The LSM difference on the treatment groups and 95% CI for the LutrePulse 20 µg group compared to placebo based on the fitted linear model were reported. Type III sum-of-squares for the LSMs were used for statistical comparisons.|Mean P4 levels in the LutrePulse 20 µg group were compared to placebo using an ANCOVA model including the randomization scheme and treatment group as factors and baseline value as covariate.||8.882|0.878|0.0187
72562790|NCT01976728|144657349|SUPERIORITY||LSM difference|0.03||||0.8772|TWO_SIDED|95.0|-0.39|0.46||The p-value was derived from an ANCOVA model with randomization scheme and treatment as factors and baseline value as covariate.|ANCOVA||LSM difference and CIs were derived from an ANCOVA model with randomization scheme and treatment as factors and baseline value as covariate.|The mean change in FSH levels from Day 10 pre-treatment (prior to first dose) in the LutrePulse 10 μg/Pulse group was compared to placebo using an ANCOVA model with randomization scheme and treatment as factors and baseline value as covariate.||0.46|-0.39|0.8772
72562791|NCT01976728|144657349|SUPERIORITY||LSM difference|0.07||||0.7805|TWO_SIDED|95.0|-0.44|0.58||The p-value was derived from an ANCOVA model with randomization scheme and treatment as factors and baseline value as covariate.|ANCOVA||LSM difference and CIs were derived from an ANCOVA model with randomization scheme and treatment as factors and baseline value as covariate.|The mean change in FSH levels from Day 10 pre-treatment (prior to first dose) in the LutrePulse 15 μg/Pulse group was compared to placebo using an ANCOVA model with randomization scheme and treatment as factors and baseline value as covariate.||0.58|-0.44|0.7805
72562792|NCT01976728|144657349|SUPERIORITY||LSM difference|0.12||||0.6095|TWO_SIDED|95.0|-0.35|0.58||The p-value was derived from an ANCOVA model with randomization scheme and treatment as factors and baseline value as covariate.|ANCOVA||LSM difference and CIs were derived from an ANCOVA model with randomization scheme and treatment as factors and baseline value as covariate.|The mean change in FSH levels from Day 10 pre-treatment (prior to first dose) in the LutrePulse 20 μg/Pulse group was compared to placebo using an ANCOVA model with randomization scheme and treatment as factors and baseline value as covariate.||0.58|-0.35|0.6095
72562793|NCT01976728|144657350|SUPERIORITY||LSM difference|0.51||||0.152|TWO_SIDED|95.0|-0.2|1.22||The p-value was derived from an ANCOVA model with randomization scheme and treatment as factors and baseline value as covariate.|ANCOVA||LSM difference and CIs were derived from an ANCOVA model with randomization scheme and treatment as factors and baseline value as covariate.|The mean change in LH levels from Day 10 pre-treatment (prior to first dose) in the LutrePulse 10 μg/Pulse group was compared to placebo using an ANCOVA model with randomization scheme and treatment as factors and baseline value as covariate.||1.22|-0.20|0.1520
72620506|NCT02656173|144772251|SUPERIORITY||Least square mean difference|-0.29||||0.009|TWO_SIDED|95.0|-0.51|-0.07|||ANCOVA|||Subscale: Quality of Life (QoL) Item. ANCOVA was used for analysis including treatment group and region as fixed factors and baseline as a covariate.||-0.07|-0.51|0.009
72620507|NCT02656173|144772252|SUPERIORITY||Least square mean difference|-4.52|||<|0.001|TWO_SIDED|95.0|-6.91|-2.13|||ANCOVA|||Analysis of Covariance (ANCOVA) was used for analysis including treatment group and region as fixed factors and baseline as a covariate.||-2.13|-6.91|<0.001
72455189|NCT03924869|144433547|OTHER||Mean Difference (Final Values)|1.24||||0.5482|TWO_SIDED|95.0|-2.83|5.31|||cLDA model|||LS Mean change and 95% CIs were based on a cLDA model with the EORTC QLQ-LC13 scores as the response variable with covariates for treatment by study visit interaction, and stratification factors by Disease Stage (Stage I versus Stage II), ECOG Performance Status (0 or 1 versus 2), Geographic Region of Enrollment Site (East Asia versus non-East Asia), and Reason For Not Receiving Surgery (medically inoperable versus refused surgery).||5.31|-2.83|0.5482
72455190|NCT03924869|144433548|OTHER||Mean Difference (Final Values)|-0.99||||0.7253|TWO_SIDED|95.0|-6.5|4.53|||cLDA model|||LS Mean change and 95% CIs were based on a cLDA model with the EORTC QLQ-C30 scores as the response variable with covariates for treatment by study visit interaction, and stratification factors by Disease Stage (Stage I versus Stage II), ECOG Performance Status (0 or 1 versus 2), Geographic Region of Enrollment Site (East Asia versus non-East Asia), and Reason For Not Receiving Surgery (medically inoperable versus refused surgery).||4.53|-6.50|0.7253
72455191|NCT03924869|144433549|OTHER||Mean Difference (Final Values)|-0.21||||0.9055|TWO_SIDED|95.0|-3.7|3.28|||cLDA model|||LS Mean change and 95% CIs were based on a cLDA model with the EORTC QLQ-C30 scores as the response variable with covariates for treatment by study visit interaction, and stratification factors by Disease Stage (Stage I versus Stage II), ECOG Performance Status (0 or 1 versus 2), Geographic Region of Enrollment Site (East Asia versus non-East Asia), and Reason For Not Receiving Surgery (medically inoperable versus refused surgery).||3.28|-3.70|0.9055
72455192|NCT04837937|144433625|SUPERIORITY||Mean Difference (Final Values)|0.1491|STANDARD_ERROR_OF_MEAN|0.51||0.7695||95.0|-0.856|1.15||Alpha for significance=0.05 for all tests.|Mixed Models Analysis|||"Generalized Linear Mixed Model (all models evaluated in SAS 9.4) testing all levels and combinations of treatments and time as fixed effects, controlling for repeated assessments within-subjects, for effect on the outcome of change in Neuro-QoL positive affect and well being score. This result is for the physician treatment arm."||1.15|-.856|.7695
72455193|NCT04837937|144433625|SUPERIORITY||Mean Difference (Final Values)|-0.87|STANDARD_ERROR_OF_MEAN|0.5077||0.0878||95.0|-1.88|0.13||ALPHA=0.05|Mixed Models Analysis|||"Generalized Linear Mixed Model (all models evaluated in SAS 9.4) testing all levels and combinations of treatments and time as fixed effects, controlling for repeated assessments within-subjects, for effect on the outcome of change in Neuro-QoL positive affect and well being score. This result is for the sister treatment arm."||.13|-1.88|.0878
72455194|NCT04837937|144433625|SUPERIORITY||Mean Difference (Final Values)|0.2414|STANDARD_ERROR_OF_MEAN|0.5077||0.635||95.0|-0.76|1.25||ALPHA=0.05|Mixed Models Analysis|||"Generalized Linear Mixed Model (all models evaluated in SAS 9.4) testing all levels and combinations of treatments and time as fixed effects, controlling for repeated assessments within-subjects, for effect on the outcome of change in Neuro-QoL positive affect and well being score. This result is for the sister/physician treatment arm."||1.25|-.76|.635
72455195|NCT04837937|144433625|SUPERIORITY||Mean Difference (Final Values)|-0.06574|STANDARD_ERROR_OF_MEAN|0.5077||0.897||95.0|-1.0709|0.9394||ALPHA=0.05|Mixed Models Analysis|||"Generalized Linear Mixed Model (all models evaluated in SAS 9.4) testing all levels and combinations of treatments and time as fixed effects, controlling for repeated assessments within-subjects, for effect on the outcome of change in Neuro-QoL positive affect and well being score. This result is for the older adult treatment arm."||.9394|-1.0709|.897
72455196|NCT04837937|144433625|SUPERIORITY||Mean Difference (Final Values)|-0.01126|STANDARD_ERROR_OF_MEAN|0.5077||0.9823||95.0|-1.0164|0.9939||ALPHA=0.05|Mixed Models Analysis|||"Generalized Linear Mixed Model (all models evaluated in SAS 9.4) testing all levels and combinations of treatments and time as fixed effects, controlling for repeated assessments within-subjects, for effect on the outcome of change in Neuro-QoL positive affect and well being score. This result is for the physician/older adult treatment arm."||.9939|-1.0164|.9823
72455197|NCT04837937|144433625|SUPERIORITY||Mean Difference (Final Values)|-0.4928|STANDARD_ERROR_OF_MEAN|0.5077||0.3337||95.0|-1.4979|0.5124||ALPHA=0.05|Mixed Models Analysis|||"Generalized Linear Mixed Model (all models evaluated in SAS 9.4) testing all levels and combinations of treatments and time as fixed effects, controlling for repeated assessments within-subjects, for effect on the outcome of change in Neuro-QoL positive affect and well being score. This result is for the sister/older adult treatment arm."||.5124|-1.4979|.3337
72455198|NCT04837937|144433625|SUPERIORITY||Mean Difference (Final Values)|0.2002|STANDARD_ERROR_OF_MEAN|0.5077||0.694||95.0|-0.8049|1.2054||ALPHA=0.05|Mixed Models Analysis|||"Generalized Linear Mixed Model (all models evaluated in SAS 9.4) testing all levels and combinations of treatments and time as fixed effects, controlling for repeated assessments within-subjects, for effect on the outcome of change in Neuro-QoL positive affect and well being score. This result is for the sister/older adult/physician treatment arm."||1.2054|-.8049|.694
72499910|NCT00190775|144530101|SUPERIORITY_OR_OTHER|||||||0.903||95.0||||P-Value for Involvement.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.903
72620508|NCT02656173|144772253|SUPERIORITY||Least square mean difference|2.79|||<|0.001|TWO_SIDED|95.0|1.13|4.44|||ANCOVA|||Analysis of Covariance (ANCOVA) was used for analysis including treatment group and region as fixed factors and baseline as a covariate.||4.44|1.13|<0.001
72499911|NCT00190775|144530101|SUPERIORITY_OR_OTHER|||||||0.807||95.0||||P-Value for Control.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.807
72499912|NCT00190775|144530101|SUPERIORITY_OR_OTHER|||||||0.403||95.0||||P-Value for Values and Norms.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.403
72499913|NCT00190775|144530102|SUPERIORITY_OR_OTHER|||||||0.941||95.0||||P-Value for Task Accomplishment.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.941
72499914|NCT00190775|144530102|SUPERIORITY_OR_OTHER|||||||0.788||95.0||||P-Value for Role Performance.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.788
72499915|NCT00190775|144530102|SUPERIORITY_OR_OTHER|||||||0.391||95.0||||P-Value for Communication.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.391
72499916|NCT00190775|144530102|SUPERIORITY_OR_OTHER|||||||0.685||95.0||||P-Value for Affective Expression.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.685
72499917|NCT00190775|144530102|SUPERIORITY_OR_OTHER|||||||0.774||95.0||||P-Value for Involvement.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.774
72455199|NCT04837937|144433625|SUPERIORITY||Actual Intercept value|54.9056|STANDARD_ERROR_OF_MEAN|0.5077|<|0.0001||95.0|53.9003|55.9109||this is the Intercept value for the GLMM evaluating all combinations of treatment and time- in other words, this is the mean well-being t-score across all combinations of tx and time. Estimates in these analyses are deviations from this intercept.|Mixed Models Analysis|||Generalized Linear Mixed Model (all models evaluated in SAS 9.4) testing all levels and combinations of treatments and time as fixed effects, controlling for repeated assessments within-subjects, for effect on the outcome of change in Neuro-QoL positive affect and well being score. This result is for the intercept (all tx=0).||55.9109|53.9003|<.0001
72455200|NCT04837937|144433625|SUPERIORITY||Mean Difference (Final Values)|-0.05579|STANDARD_ERROR_OF_MEAN|0.03516||0.1152||95.0|-0.1254|0.01383||alpha=0.05|Mixed Models Analysis|||Generalized Linear Mixed Model (all models evaluated in SAS 9.4) testing all levels and combinations of treatments and time as fixed effects, controlling for repeated assessments within-subjects, for effect on the outcome of change in Neuro-QoL positive affect and well being score. This test evaluates the effect of time (measured as weeks since baseline).||.01383|-.1254|.1152
72455201|NCT04837937|144433625|SUPERIORITY||Mean Difference (Final Values)|-0.03261|STANDARD_ERROR_OF_MEAN|0.03516||0.3555||95.0|-0.1022|0.03699|||Mixed Models Analysis|||"Generalized Linear Mixed Model (all models evaluated in SAS 9.4) testing all levels and combinations of treatments and time as fixed effects, controlling for repeated assessments within-subjects, for effect on the outcome of change in Neuro-QoL positive affect and well being score. This result is for the Physician treatment arm\*time."||.03699|-.1022|.3555
72455202|NCT04837937|144433625|SUPERIORITY||Mean Difference (Final Values)|0.06825|STANDARD_ERROR_OF_MEAN|0.03516||0.0546||95.0|-0.00136|0.1379||alpha=0.05|Mixed Models Analysis|||"Generalized Linear Mixed Model (all models evaluated in SAS 9.4) testing all levels and combinations of treatments and time as fixed effects, controlling for repeated assessments within-subjects, for effect on the outcome of change in Neuro-QoL positive affect and well being score. This result is for the sister treatment arm\*time."||.1379|-.00136|.0546
72499918|NCT00190775|144530102|SUPERIORITY_OR_OTHER|||||||0.36||95.0||||P-Value for Control.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.360
72499919|NCT00190775|144530102|SUPERIORITY_OR_OTHER|||||||0.446||95.0||||P-Value for Values and Norms.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.446
72499920|NCT00190775|144530103|SUPERIORITY_OR_OTHER|||||||0.617||95.0||||P-Value for Total Dyadic Adjustment.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.617
72620509|NCT01064622|144772257|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.82||||0.15|TWO_SIDED|95.0|0.55|1.22||Reported p-value is one-sided. p\<0.10 required for statistical significance.|Log Rank|Stratified by Karnofsky performance status (90-100 vs. 80) and disease status (newly diagnosed vs. recurrent after surgery)|Hazard ratio is for (gemcitabine hydrochloride plus vismodegib)/(gemcitabine hydrochloride plus placebo), adjusted for Karnofsky performance status (90-100 vs. 80) and disease status (newly diagnosed vs. recurrent after surgery)|||1.22|0.55|0.15
72620510|NCT01064622|144772258|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.96||||0.37|TWO_SIDED|95.0|0.64|1.46|||Log Rank|Stratified by Karnofsky performance status (90-100 vs. 80) and disease status (newly diagnosed vs. recurrent after surgery)|Hazard ratio is for (gemcitabine hydrochloride plus vismodegib)/(gemcitabine hydrochloride plus placebo), adjusted for Karnofsky performance status (90-100 vs. 80) and disease status (newly diagnosed vs. recurrent after surgery)|||1.46|0.64|0.37
72620511|NCT01064622|144772259|SUPERIORITY_OR_OTHER_LEGACY|||||||0.42|TWO_SIDED|||||Two-sided p-value for Cochran-Mantel-Haenszel test stratified by Karnofsky performance status and disease status.|Cochran-Mantel-Haenszel|||||||0.42
72499921|NCT00190775|144530103|SUPERIORITY_OR_OTHER|||||||0.789||95.0||||P-Value for Dyadic Consensus.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.789
72499922|NCT00190775|144530103|SUPERIORITY_OR_OTHER|||||||0.67||95.0||||P-Value for Dyadic Satisfaction.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.670
72499923|NCT00190775|144530103|SUPERIORITY_OR_OTHER|||||||0.018||95.0||||P-Value for Affectional Expression.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.018
72499924|NCT00190775|144530103|SUPERIORITY_OR_OTHER|||||||0.405||95.0||||P-Value for Dyadic Cohesion.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.405
72499925|NCT00190775|144530104|SUPERIORITY_OR_OTHER|||||||0.544||95.0||||P-Value for Total Dyadic Adjustment.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.544
72499926|NCT00190775|144530104|SUPERIORITY_OR_OTHER|||||||0.494||95.0||||P-Value for Dyadic Consensus.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.494
72499927|NCT00190775|144530104|SUPERIORITY_OR_OTHER|||||||0.547||95.0||||P-Value for Dyadic Satisfaction.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.547
72499928|NCT00190775|144530104|SUPERIORITY_OR_OTHER|||||||0.059||95.0||||P-Value for Affectional Expression.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.059
72499929|NCT00190775|144530104|SUPERIORITY_OR_OTHER|||||||0.918||95.0||||P-Value for Dyadic Cohesion.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.918
72499930|NCT00190775|144530105|SUPERIORITY_OR_OTHER|||||||0.334||95.0||||P-Value for Total Dyadic Adjustment.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.334
72499931|NCT00190775|144530105|SUPERIORITY_OR_OTHER|||||||0.087||95.0||||P-Value for Dyadic Consensus.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.087
72499932|NCT00190775|144530105|SUPERIORITY_OR_OTHER|||||||0.795||95.0||||P-Value for Dyadic Satisfaction.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.795
72499933|NCT00190775|144530105|SUPERIORITY_OR_OTHER|||||||0.955||95.0||||P-Value for Affectional Expression.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.955
72499934|NCT00190775|144530105|SUPERIORITY_OR_OTHER|||||||0.788||95.0||||P-Value for Dyadic Cohesion.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.788
72455203|NCT04837937|144433625|SUPERIORITY||Mean Difference (Final Values)|0.02597|STANDARD_ERROR_OF_MEAN|0.03516||0.4616||95.0|-0.04364|0.09557||alpha=0.05|Mixed Models Analysis|||"Generalized Linear Mixed Model (all models evaluated in SAS 9.4) testing all levels and combinations of treatments and time as fixed effects, controlling for repeated assessments within-subjects, for effect on the outcome of change in Neuro-QoL positive affect and well being score. This result is for the Sister/Physician treatment arm\*time."||.09557|-.04364|.4616
72455204|NCT04837937|144433625|SUPERIORITY||Mean Difference (Final Values)|0.0498|STANDARD_ERROR_OF_MEAN|0.03516||0.1592||95.0|-0.0198|0.1194||alpha=0.05|Mixed Models Analysis|||"Generalized Linear Mixed Model (all models evaluated in SAS 9.4) testing all levels and combinations of treatments and time as fixed effects, controlling for repeated assessments within-subjects, for effect on the outcome of change in Neuro-QoL positive affect and well being score. This result is for the Older Adult treatment arm\*time."||.1194|-.0198|.1592
72455205|NCT04837937|144433625|SUPERIORITY||Mean Difference (Final Values)|-0.02435|STANDARD_ERROR_OF_MEAN|0.03516||0.4899||95.0|-0.09396|0.04526|||Mixed Models Analysis|||"Generalized Linear Mixed Model (all models evaluated in SAS 9.4) testing all levels and combinations of treatments and time as fixed effects, controlling for repeated assessments within-subjects, for effect on the outcome of change in Neuro-QoL positive affect and well being score. This result is for the Physician/Older Adult treatment arm\*time."||.04526|-.09396|.4899
72455206|NCT04837937|144433625|SUPERIORITY||Mean Difference (Final Values)|0.000697|STANDARD_ERROR_OF_MEAN|0.03516||0.9842||95.0|-0.06891|0.0703||alpha=0.05|Mixed Models Analysis|||"Generalized Linear Mixed Model (all models evaluated in SAS 9.4) testing all levels and combinations of treatments and time as fixed effects, controlling for repeated assessments within-subjects, for effect on the outcome of change in Neuro-QoL positive affect and well being score. This result is for the sister/older adult treatment arm\*time."||.0703|-.06891|.9842
72455207|NCT04837937|144433625|SUPERIORITY||Mean Difference (Final Values)|-0.01255|STANDARD_ERROR_OF_MEAN|0.03516||0.7217||95.0|-0.08216|0.05705||alpha=0.05|Mixed Models Analysis|||"Generalized Linear Mixed Model (all models evaluated in SAS 9.4) testing all levels and combinations of treatments and time as fixed effects, controlling for repeated assessments within-subjects, for effect on the outcome of change in Neuro-QoL positive affect and well being score. This result is for the Sister/Older Adult/Physician treatment arm\*time."||.05705|-.08216|.7217
72455208|NCT04837937|144433626|SUPERIORITY||Mean Difference (Final Values)|-0.74|STANDARD_DEVIATION|6.55||0.21||95.0|-1.9|0.42||Threshold for statistical significance was alpha=0.05.|2-sided paired t-Test|||Univariate ANOVA- analytic variable is change in PROMIS Anxiety score from baseline to T3. Test is a paired T-Test.||.42|-1.90|.21
72455209|NCT04837937|144433627|SUPERIORITY||Mean Difference (Final Values)|-3.24|STANDARD_DEVIATION|11.54||0.0021||95.0|-5.28|-1.2||Threshold for significance was 0.05.|2-sided dependent sample t-test|||Univariate ANOVA on change in Zarit Caregiver Burden Score, Baseline to 1-month post-intervention. Test was a 2-sided dependent samples t-test.||-1.20|-5.28|.0021
72455210|NCT04837937|144433628|SUPERIORITY||Mean Difference (Final Values)|-1.19|STANDARD_DEVIATION|8.1||0.1||95.0|-2.62|0.25||Alpha for statistical significance was 0.05|2-Sided Paired T Test|||Univariate ANOVA- analytic variable is change in PROMIS Fatigue score from baseline to T3. Test is a paired T-Test.||.25|-2.62|.10
72455211|NCT04837937|144433629|SUPERIORITY||Mean Difference (Final Values)|0.02|STANDARD_DEVIATION|7.83||0.9754||95.0|-1.36|1.41|||2-sided paired (dependent sample) t-test|||Univariate ANOVA on change in PROMIS short form General Self Efficacy T-Score, baseline to one month post-intervention. Test is a 2-sided paired (dependent sample) t-test.||1.41|-1.36|.9754
72455212|NCT04837937|144433631|SUPERIORITY||Mean Difference (Final Values)|0.1296|STANDARD_DEVIATION|4.91||0.77||95.0|-0.74|1.0||Threshold for significance is 0.05|2-sided Paired T-Test|||Univariate ANOVA on change in T-Score between baseline and 1 month post-intervention. Test is a 2-sided paired t-test.||1.00|-.74|.77
72455213|NCT04837937|144433632|SUPERIORITY||Mean Difference (Final Values)|0.7618|STANDARD_DEVIATION|6.16||0.1694||95.0|-0.33|1.85||alpha threshold for significance was 0.05.|two-sided paired T-Test|||Univariate ANOVA on change in T-score between baseline and one month post-intervention. Test is a two-sided paired t-test.||1.85|-.33|.1694
72455214|NCT04837937|144433637|SUPERIORITY||Mean Difference (Final Values)|-0.45|STANDARD_DEVIATION|16.44||0.76||||||Alpha for Significance=0.05|ANOVA|||Univariate ANOVA on change in Avoiding Score (out of 100) between Baseline and 1 Month Post-Intervention.||||.76
72455215|NCT04837937|144433637|SUPERIORITY||Mean Difference (Final Values)|2.25|STANDARD_DEVIATION|16.33||0.13||||||Alpha for significance=0.05|ANOVA|||Univariate ANOVA on change in Compromising Score (out of 100) between Baseline and 1 Month Post-Intervention.||||.13
72455216|NCT04837937|144433637|SUPERIORITY||Mean Difference (Final Values)|-6.85|STANDARD_DEVIATION|18.76|<|0.0001||||||Alpha for significance=0.05|ANOVA|||Univariate ANOVA on change in Forcing Score (out of 100) between Baseline and 1 Month Post-Intervention.||||<.0001
72455217|NCT04837937|144433637|SUPERIORITY||Mean Difference (Final Values)|-0.25|STANDARD_DEVIATION|15.62||0.86||||||Alpha for Significance=0.05|ANOVA|||Univariate ANOVA on change in Problem Solving Score (out of 100) between Baseline and 1 Month Post-Intervention.||||.86
72455218|NCT04837937|144433637|SUPERIORITY||Mean Difference (Final Values)|-1.1|STANDARD_DEVIATION|12.3||0.32||||||Alpha for significance=0.05|ANOVA|||Univariate ANOVA on change in Yielding Score (out of 100) between Baseline and 1 Month Post-Intervention.||||.32
72455219|NCT04837937|144433638|SUPERIORITY||Mean Difference (Final Values)|3.09|STANDARD_DEVIATION|13.18||0.0012||95.0|||||ANOVA|||Univariate ANOVA on change in total Negotiation Knowledge score, Baseline 1-month. Threshold for significance was alpha=0.05.||||.0012
72455220|NCT04837937|144433638|SUPERIORITY||Mean Difference (Final Values)|4.933|STANDARD_DEVIATION|17.33||0.0018||||||alpha=0.05|ANOVA|||Univariate ANOVA on change in Negotiation Knowledge Interests score, Baseline 1-month. Threshold for significance was alpha=0.05.||||.0018
72455221|NCT04837937|144433638|SUPERIORITY||Mean Difference (Final Values)|0.2|STANDARD_DEVIATION|19.69||0.91||||||Threshold for significance was alpha=0.05.|ANOVA|||Univariate ANOVA on change in Negotiation Knowledge Power score, Baseline 1-month.||||.91
72499935|NCT00190775|144530106|SUPERIORITY_OR_OTHER|||||||0.248||95.0||||P-Value for Total Dyadic Adjustment.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.248
72620512|NCT03449147|144772299|SUPERIORITY||Estimated Relative Reduction (%)|-1.14||||0.875|TWO_SIDED|95.0|-14.27|14.02||Comparison based on a longitudinal ANCOVA model that included treatment, visit, treatment-by-visit interaction, gender, region, log-transformed baseline value, and log-transformed baseline value-by-visit as covariates.|ANCOVA|||Estimated relative reduction (ERR) relative to Placebo (i.e. estimated percent change difference) was calculated by 100 (e\*\*DIFF -1), where e = exponent of difference; and DIFF= treatment difference in change from baseline at Week 24 based on log transformed data.||14.02|-14.27|0.875
72620513|NCT03449147|144772299|SUPERIORITY||Estimated Relative Reduction (%)|-14.64||||0.031|TWO_SIDED|95.0|-26.07|-1.43||Comparison based on a longitudinal ANCOVA model that included treatment, visit, treatment-by-visit interaction, gender, region, log-transformed baseline value, and log-transformed baseline value-by-visit as covariates.|ANCOVA|||ERR relative to Placebo (i.e. estimated percent change difference) was calculated by 100 (e\*\*DIFF -1), where e = exponent of difference; and DIFF= treatment difference in change from baseline at Week 24 based on log transformed data.||-1.43|-26.07|0.031
72620514|NCT03449147|144772302|SUPERIORITY||Estimated Relative Reduction (%)|-3.03||||0.677|TWO_SIDED|95.0|-16.14|12.12||Comparison based on a longitudinal ANCOVA model that included treatment, visit, treatment-by-visit interaction, gender, region, log-transformed baseline value, and log-transformed baseline value-by-visit as covariates.|ANCOVA|||Estimated relative reduction (ERR) relative to Placebo (i.e. estimated percent change difference) was calculated by 100 (e\*\*DIFF -1), where e = exponent of difference; and DIFF= treatment difference in change from baseline at Week 24 based on log transformed data.||12.12|-16.14|0.677
72455222|NCT04837937|144433638|SUPERIORITY||Mean Difference (Final Values)|3.2|STANDARD_DEVIATION|22.35||0.11||||||Threshold for significance was alpha=0.05.|ANOVA|||Univariate ANOVA on change in Negotiation Knowledge Rights score, Baseline 1-month.||||.11
72455223|NCT04837937|144433640|SUPERIORITY||Mean Difference (Final Values)|-2.08|STANDARD_DEVIATION|5.73|<|0.0001||95.0|-3.09|-1.07||Threshold for significance is alpha=0.05.|2-sided dependent sample t-test|||Univariate ANOVA on change in negative affect score, baseline-1 month post-intervention. Test is a 2 sided dependent sample t-test.||-1.07|-3.09|<.0001
72455224|NCT04837937|144433640|SUPERIORITY||Mean Difference (Final Values)|0.344|STANDARD_DEVIATION|4.86||0.4305||95.0|-0.52|1.21|||2-sided dependent sample t-test|||Univariate ANOVA of change in positive affect score between baseline-1 month post-intervention. Test is a 2-sided dependent sample t-test.||1.21|-.52|.4305
72455225|NCT01767688|144433660|SUPERIORITY_OR_OTHER||Geometric least-squares mean ratio (GMR)|0.94|||||TWO_SIDED|95.0|0.79|1.11|||Geometric least-squares mean ratio (GMR)|||||1.11|0.79|
72455226|NCT01767688|144433661|SUPERIORITY_OR_OTHER||Geometric least-squares mean ratio (GMR)|0.94|||||TWO_SIDED|95.0|0.81|1.1|||Geometric least-squares mean ratio (GMR)|||||1.10|0.81|
72455227|NCT01767688|144433662|SUPERIORITY_OR_OTHER||Geometric least-squares mean ratio (GMR)|0.81|||||TWO_SIDED|95.0|0.51|1.28|||Geometric least-squares mean ratio (GMR)|||||1.28|0.51|
72455228|NCT01767688|144433663|SUPERIORITY_OR_OTHER||Geometric least-squares mean ratio (GMR)|1.03|||||TWO_SIDED|95.0|0.93|1.15|||Geometric least-squares mean ratio (GMR)|||||1.15|0.93|
72455229|NCT02148705|144433723|SUPERIORITY||Odds Ratio (OR)|288.281|||<|0.0001|TWO_SIDED|95.0|35.549|13984.356|||Fisher Exact|||||13984.356|35.549|<0.0001
72455230|NCT02148705|144433724|SUPERIORITY||Odds Ratio (OR)|0.011|||<|0.0001|TWO_SIDED|95.0|0.003|0.044|||Chi-squared|||||0.044|0.003|<0.0001
72455231|NCT02148705|144433725|SUPERIORITY||Test Statistics|23.1429|||<|0.0001|TWO_SIDED||||||Generalized Wilcoxon-Gehan Test|Analysis is adjusted for Overall TW Depths, TBSA Group, Center Group, and Number of TWs||||||<0.0001
72620515|NCT03449147|144772302|SUPERIORITY||Estimated Relative Reduction (%)|-15.79||||0.022|TWO_SIDED|95.0|-27.27|-2.5||Comparison based on a longitudinal ANCOVA model that included treatment, visit, treatment-by-visit interaction, gender, region, log-transformed baseline value, and log-transformed baseline value-by-visit as covariates.|ANCOVA|||ERR relative to Placebo (i.e. estimated percent change difference) was calculated by 100 (e\*\*DIFF -1), where e = exponent of difference; and DIFF= treatment difference in change from baseline at Week 24 based on log transformed data.||-2.50|-27.27|0.022
72620516|NCT03449147|144772303|SUPERIORITY||Odds Ratio (OR)|1.34||||0.077|TWO_SIDED|95.0|0.97|1.85||Comparison based on logistic regression model that included treatment, visit, treatment-by-visit interaction, gender, region, baseline LCQ total score, and the interaction of baseline LCQ total score by visit as covariates.|Regression, Logistic|||||1.85|0.97|0.077
72455232|NCT02148705|144433726|SUPERIORITY||estimate|6505.8|STANDARD_ERROR_OF_MEAN|269.88|<|0.0001|TWO_SIDED|95.0|5974.41|7037.19|||Wilcoxon (Mann-Whitney)|Wilcoxon tests pooled using Rubin´s rule||||7037.19|5974.41|<0.0001
72455233|NCT01583166|144433728|OTHER|||||||0.837|||||||Fisher Exact|||||||0.837
72455234|NCT02310581|144433731|OTHER||LS Mean Difference|104.973|STANDARD_ERROR_OF_MEAN|39.2433||0.012|TWO_SIDED|95.0|25.13|184.81|||ANCOVA|The analysis included treatment and site as main effects and Baseline pain intensity as the covariate.||||184.81|25.13|0.012
72455235|NCT02310581|144433731|OTHER||LS Mean Difference|86.316|STANDARD_ERROR_OF_MEAN|37.5385||0.028|TWO_SIDED|95.0|9.94|162.69|||ANCOVA|The analysis included treatment and site as main effects and Baseline pain intensity as the covariate.||||162.69|9.94|0.028
72455236|NCT02310581|144433731|OTHER||LS Mean Difference|64.485|STANDARD_ERROR_OF_MEAN|39.2459||0.11|TWO_SIDED|95.0|-15.36|144.33|||ANCOVA|The analysis included treatment and site as main effects and Baseline pain intensity as the covariate.||||144.33|-15.36|0.110
72455237|NCT02310581|144433734|OTHER||LS Mean Difference|14.398|STANDARD_ERROR_OF_MEAN|4.739||0.005|TWO_SIDED|95.0|4.76|24.04|||ANCOVA|The analysis included treatment and site as main effects and Baseline pain intensity as the covariate.||||24.04|4.76|0.005
72455238|NCT02310581|144433734|OTHER||LS Mean Difference|8.056|STANDARD_ERROR_OF_MEAN|4.5331||0.085|TWO_SIDED|95.0|-1.17|17.28|||ANCOVA|The analysis included treatment and site as main effects and Baseline pain intensity as the covariate.||||17.28|-1.17|0.085
72455239|NCT02310581|144433734|OTHER||LS Mean Difference|10.063|STANDARD_ERROR_OF_MEAN|4.7393||0.041|TWO_SIDED|95.0|0.42|19.7|||ANCOVA|The analysis included treatment and site as main effects and Baseline pain intensity as the covariate.||||19.70|0.42|0.041
72455240|NCT02310581|144433735|OTHER||LS Mean Difference|26.665|STANDARD_ERROR_OF_MEAN|8.1991||3|TWO_SIDED|95.0|9.98|43.35|||ANCOVA|The analysis included treatment and site as main effects and Baseline pain intensity as the covariate.||||43.35|9.98|0003
72391866|NCT00256750|144290858|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|0.8||||0.4209|TWO_SIDED|95.0|-1.1|2.7|||ANCOVA|Adjusted mean based on an ANCOVA model with treatment as factor, and baseline value as covariate.|Statistical tests comparing each belatacept regimen to the CsA regimen were conducted at a significance level of 0.05. Subjects with only baseline observations were excluded from these summaries.|Mental Component Score; Month 12||2.7|-1.1|0.4209
72391867|NCT00256750|144290858|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|1.6||||0.0526|TWO_SIDED|95.0|0.0|3.2|||ANCOVA|Adjusted mean based on an ANCOVA model with treatment as factor, and baseline value as covariate.|Statistical tests comparing each belatacept regimen to the CsA regimen were conducted at a significance level of 0.05. Subjects with only baseline observations were excluded from these summaries.|Physical Component Score; Month 12||3.2|-0.0|0.0526
72455241|NCT02310581|144433735|OTHER||LS Mean Difference|21.605|STANDARD_ERROR_OF_MEAN|7.8429||0.009|TWO_SIDED|95.0|5.65|37.56|||ANCOVA|The analysis included treatment and site as main effects and Baseline pain intensity as the covariate.||||37.56|5.65|0.009
72391868|NCT00256750|144290858|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|2.2||||0.0077|TWO_SIDED|95.0|0.6|3.9|||ANCOVA|Adjusted mean based on an ANCOVA model with treatment as factor, and baseline value as covariate.|Statistical tests comparing each belatacept regimen to the CsA regimen were conducted at a significance level of 0.05. Subjects with only baseline observations were excluded from these summaries.|Physical Component Score; Month 12||3.9|0.6|0.0077
72620517|NCT03449147|144772303|SUPERIORITY||Odds Ratio (OR)|1.41||||0.04|TWO_SIDED|95.0|1.02|1.96||Comparison based on logistic regression model that included treatment, visit, treatment-by-visit interaction, gender, region, baseline LCQ total score, and the interaction of baseline LCQ total score by visit as covariates.|Regression, Logistic|||||1.96|1.02|0.040
72391869|NCT00256750|144290858|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|1.4||||0.1849|TWO_SIDED|95.0|-0.6|3.4|||ANCOVA|Adjusted mean based on an ANCOVA model with treatment as factor, and baseline value as covariate.|Statistical tests comparing each belatacept regimen to the CsA regimen were conducted at a significance level of 0.05. Subjects with only baseline observations were excluded from these summaries.|Mental Component Score; Month 24||3.4|-0.6|0.1849
72391870|NCT00256750|144290858|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|0.8||||0.4633|TWO_SIDED|95.0|-1.3|2.8|||ANCOVA|Adjusted mean based on an ANCOVA model with treatment as factor, and baseline value as covariate.|Statistical tests comparing each belatacept regimen to the CsA regimen were conducted at a significance level of 0.05. Subjects with only baseline observations were excluded from these summaries.|Mental Component Score; Month 24||2.8|-1.3|0.4633
72391871|NCT00256750|144290858|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|1.4||||0.0971|TWO_SIDED|95.0|-0.3|3.0|||ANCOVA|Adjusted mean based on an ANCOVA model with treatment as factor, and baseline value as covariate.|Statistical tests comparing each belatacept regimen to the CsA regimen were conducted at a significance level of 0.05. Subjects with only baseline observations were excluded from these summaries.|Physical Component Score; Month 24||3.0|-0.3|0.0971
72391872|NCT00256750|144290858|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|2.2||||0.0102|TWO_SIDED|95.0|0.5|3.8|||ANCOVA|Adjusted mean based on an ANCOVA model with treatment as factor, and baseline value as covariate.|Statistical tests comparing each belatacept regimen to the CsA regimen were conducted at a significance level of 0.05. Subjects with only baseline observations were excluded from these summaries.|Physical Component Score; Month 24||3.8|0.5|0.0102
72391873|NCT00256750|144290858|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|2.5||||0.0186|TWO_SIDED|95.0|0.4|4.5|||ANCOVA|Adjusted mean based on an ANCOVA model with treatment as factor, and baseline value as covariate.|Statistical tests comparing each belatacept regimen to the CsA regimen were conducted at a significance level of 0.05. Subjects with only baseline observations were excluded from these summaries.|Mental Component Score; Month 36||4.5|0.4|0.0186
72391874|NCT00256750|144290858|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|1.9||||0.0775|TWO_SIDED|95.0|-0.2|4.0|||ANCOVA|Adjusted mean based on an ANCOVA model with treatment as factor, and baseline value as covariate.|Statistical tests comparing each belatacept regimen to the CsA regimen were conducted at a significance level of 0.05. Subjects with only baseline observations were excluded from these summaries.|Mental Component Score; Month 36||4.0|-0.2|0.0775
72391875|NCT00256750|144290858|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|1.6||||0.0768|TWO_SIDED|95.0|-0.2|3.3|||ANCOVA|Adjusted mean based on an ANCOVA model with treatment as factor, and baseline value as covariate.|Statistical tests comparing each belatacept regimen to the CsA regimen were conducted at a significance level of 0.05. Subjects with only baseline observations were excluded from these summaries.|Physical Component Score; Month 36||3.3|-0.2|0.0768
72391876|NCT00256750|144290858|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|1.2||||0.1876|TWO_SIDED|95.0|-0.6|2.9|||ANCOVA|Adjusted mean based on an ANCOVA model with treatment as factor, and baseline value as covariate.|Statistical tests comparing each belatacept regimen to the CsA regimen were conducted at a significance level of 0.05. Subjects with only baseline observations were excluded from these summaries.|Physical Component Score; Month 36||2.9|-0.6|0.1876
72391877|NCT00256750|144290860|NON_INFERIORITY_OR_EQUIVALENCE|A non-inferiority margin of 10% for the co-primary endpoint of participant and graft survival was used. Determination of a margin for non-inferiority based on 'preservation of benefit' is not feasible, given the low rate of patient death and/or graft loss in the first year post-transplantation, and the absence of published, adequately sized, parallel-group trials with which to assess the effect of CsA on patient death and/or graft loss in the setting of MMF/steroids/basiliximab.|Difference in Percent|4.2|||||TWO_SIDED|97.3|-1.3|10.1||||||Month 24||10.1|-1.3|
72455242|NCT02310581|144433735|OTHER||LS Mean Difference|22.143|STANDARD_ERROR_OF_MEAN|8.1997||0.011|TWO_SIDED|95.0|5.46|38.83|||ANCOVA|The analysis included treatment and site as main effects and Baseline pain intensity as the covariate.||||38.83|5.46|0.011
72455243|NCT02310581|144433736|OTHER||LS Mean Difference|63.881|STANDARD_ERROR_OF_MEAN|18.3971||0.001|TWO_SIDED|95.0|26.45|101.31|||ANCOVA|The analysis included treatment and site as main effects and Baseline pain intensity as the covariate.||||101.31|26.45|0.001
72499936|NCT00190775|144530106|SUPERIORITY_OR_OTHER|||||||0.163||95.0||||P-Value for Dyadic Consensus.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.163
72499937|NCT00190775|144530106|SUPERIORITY_OR_OTHER|||||||0.947||95.0||||P-Value for Dyadic Satisfaction.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.947
72620518|NCT03449147|144772304|SUPERIORITY||Odds Ratio (OR)|1.03||||0.872|TWO_SIDED|95.0|0.75|1.4||Comparison based on a logistic regression model that included treatment, visit, treatment-by-visit interaction, gender, region, baseline 24-hour coughs per hour and the interaction of baseline 24-hour coughs per hour as covariates.|Regression, Logistic|||||1.40|0.75|0.872
72620519|NCT03449147|144772304|SUPERIORITY||Odds Ratio (OR)|1.33||||0.082|TWO_SIDED|95.0|0.96|1.83||Comparison based on a logistic regression model that included treatment, visit, treatment-by-visit interaction, gender, region, baseline 24-hour coughs per hour and the interaction of baseline 24-hour coughs per hour as covariates.|Regression, Logistic|||||1.83|0.96|0.082
72620520|NCT03449147|144772305|OTHER||Odds Ratio (OR)|1.33|||||TWO_SIDED|95.0|0.96|1.83||||||Comparison based on a logistic regression model that included treatment, visit, treatment-by-visit interaction, gender, region, baseline mean weekly CSD total score, and the interaction of baseline mean weekly CSD total score by visit as covariates.||1.83|0.96|
72620521|NCT03449147|144772305|OTHER||Odds Ratio (OR)|1.5|||||TWO_SIDED|95.0|1.08|2.09||||||Comparison based on a logistic regression model that included treatment, visit, treatment-by-visit interaction, gender, region, baseline mean weekly CSD total score, and the interaction of baseline mean weekly CSD total score by visit as covariates.||2.09|1.08|
72620522|NCT03449147|144772306|OTHER||Odds Ratio (OR)|1.25|||||TWO_SIDED|95.0|0.93|1.69||||||Comparison based on a logistic regression model that included treatment, visit, treatment-by-visit interaction, gender, region, baseline mean weekly CSD total score, and the interaction of baseline mean weekly CSD total score by visit as covariates.||1.69|0.93|
72620523|NCT03449147|144772306|OTHER||Odds Ratio (OR)|1.77|||||TWO_SIDED|95.0|1.31|2.39||||||Comparison based on a logistic regression model that included treatment, visit, treatment-by-visit interaction, gender, region, baseline mean weekly CSD total score, and the interaction of baseline mean weekly CSD total score by visit as covariates.||2.39|1.31|
72620524|NCT03449147|144772307|OTHER||Odds Ratio (OR)|1.53|||||TWO_SIDED|95.0|1.14|2.05||||||Comparison based on a logistic regression model that included treatment, visit, treatment-by-visit interaction, gender, region, baseline mean weekly VAS score, and the interaction of baseline mean weekly VAS score by visit as covariates.||2.05|1.14|
72620525|NCT03449147|144772307|OTHER||Odds Ratio (OR)|1.65||||||95.0|1.23|2.22||||||Comparison based on a logistic regression model that included treatment, visit, treatment-by-visit interaction, gender, region, baseline mean weekly VAS score, and the interaction of baseline mean weekly VAS score by visit as covariates.||2.22|1.23|
72620526|NCT02037984|144772312|OTHER|PT1 GMC Ratio (V114/Prevnar 13®)|PT1 GMC Ratio|0.81|||||TWO_SIDED|95.0|0.6|1.1||||||||1.10|0.60|
72455244|NCT02310581|144433736|OTHER||LS Mean Difference|50.284|STANDARD_ERROR_OF_MEAN|17.5979||0.007|TWO_SIDED|95.0|14.48|86.09|||ANCOVA|The analysis included treatment and site as main effects and Baseline pain intensity as the covariate.||||86.09|14.48|0.007
72620527|NCT02037984|144772312|OTHER|PT3 GMC Ratio (V114/Prevnar 13®)|PT3 GMC Ratio|2.22|||||TWO_SIDED|95.0|1.64|3.02||||||||3.02|1.64|
72391878|NCT00256750|144290860|NON_INFERIORITY_OR_EQUIVALENCE|A non-inferiority margin of 10% for the co-primary endpoint of participant and graft survival was used. Determination of a margin for non-inferiority based on 'preservation of benefit' is not feasible, given the low rate of patient death and/or graft loss in the first year post-transplantation, and the absence of published, adequately sized, parallel-group trials with which to assess the effect of CsA on patient death and/or graft loss in the setting of MMF/steroids/basiliximab.|Difference in Percent|3.6|||||TWO_SIDED|97.3|-2.2|9.6||||||Month 24||9.6|-2.2|
72455245|NCT02310581|144433736|OTHER||LS Mean Difference|56.879|STANDARD_ERROR_OF_MEAN|18.3984||0.004|TWO_SIDED|95.0|19.45|94.31|||ANCOVA|The analysis included treatment and site as main effects and Baseline pain intensity as the covariate.||||94.31|19.45|0.004
72620528|NCT02037984|144772312|OTHER|PT4 GMC Ratio (V114/Prevnar 13®)|PT4 GMG Ratio|1.37|||||TWO_SIDED|95.0|1.01|1.84||||||||1.84|1.01|
72620529|NCT02037984|144772312|OTHER|PT5 GMC Ratio (V114/Prevnar 13®)|PT5 GMC Ratio|0.71|||||TWO_SIDED|95.0|0.48|1.05||||||||1.05|0.48|
72620530|NCT02037984|144772312|OTHER|PT6A GMC Ratio (V114/Prevnar 13®)|PT6A GMC Ratio|0.6|||||TWO_SIDED|95.0|0.32|1.13||||||||1.13|0.32|
72455246|NCT03345979|144433761|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<.001
72455247|NCT03345979|144433761|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<.001
72455248|NCT00487240|144433768|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority limit of 0.4% using the upper limit of a two-sided test at a significance level of 0.05 with 90% power assuming a 1.1 Standard Deviations (SD)|Mean Difference (Net)|-0.1||||0.332||95.0|-0.29|0.1|||ANCOVA|ANCOVA Model: Variable=Treatment + Baseline + Country.|Least Squares Mean Difference = Insulin Lispro Protamine Suspension minus Detemir.|Hypothesis: basal analog insulin lispro protamine suspension (ILPS), is inferior to basal analog insulin detemir, as measured by change in HbA1c from baseline to endpoint.||0.10|-0.29|0.332
72620531|NCT02037984|144772312|OTHER|PT6B GMC Ratio (V114/Prevnar 13®)|PT6B GMG Ratio|0.34|||||TWO_SIDED|95.0|0.16|0.73||||||||0.73|0.16|
72620532|NCT02037984|144772312|OTHER|PT7F GMC Ratio (V114/Prevnar 13®)|PT7F GMC Ratio|0.72|||||TWO_SIDED|95.0|0.51|1.02||||||||1.02|0.51|
72620533|NCT02037984|144772312|OTHER|PT9V GMC Ratio (V114/Prevnar 13®)|PT9V GMC Ratio|0.74|||||TWO_SIDED|95.0|0.51|1.08||||||||1.08|0.51|
72620534|NCT02037984|144772312|OTHER|PT14 GMC Ratio (V114/Prevnar®)|PT9V GMC Ratio|0.59|||||TWO_SIDED|95.0|0.39|0.9||||||||0.90|0.39|
72620535|NCT02037984|144772312|OTHER|PT18C GMC Ratio (V114/Prevnar 13®)|PT18C GMC Ratio|0.92|||||TWO_SIDED|95.0|0.64|1.31||||||||1.31|0.64|
72620536|NCT02037984|144772312|OTHER|PT19A GMC Ratio (V114/Prevnar 13®)|PT19A GMC Ratio|0.88|||||TWO_SIDED|95.0|0.61|1.27||||||||1.27|0.61|
72620537|NCT02037984|144772312|OTHER|PT19F GMC Ratio (V114/Prevnar 13®)|PT19F GMC Ratio|1.22|||||TWO_SIDED|95.0|0.83|1.78||||||||1.78|0.83|
72620538|NCT02037984|144772312|OTHER|PT23F GMC Ratio (V114/Prevnar 13®)|PT23F GMC Ratio|0.91|||||TWO_SIDED|95.0|0.57|1.45||||||||1.45|0.57|
72620539|NCT02037984|144772312|OTHER|non-PT22F GMC Ratio (V114/Prevnar 13®)|non-PT22F GMC Ratio|67.5|||||TWO_SIDED|95.0|45.58|99.97||||||||99.97|45.58|
72620540|NCT02037984|144772312|OTHER|non-PT33F GMC Ratio (V114/Prevnar 13®)|non-PT33F GMC Ratio|23.9|||||TWO_SIDED|95.0|13.21|43.24||||||||43.24|13.21|
72620541|NCT02037984|144772313|OTHER|PT1 GMC Ratio (V114/Prevnar 13®)|PT1 GMC Ratio|0.52|||||TWO_SIDED|95.0|0.39|0.7||||||||0.70|0.39|
72620542|NCT02037984|144772313|OTHER|PT3 GMC Ratio (V114/Prevnar 13®)|PT3 GMC Ratio|1.79|||||TWO_SIDED|95.0|1.33|2.41||||||||2.41|1.33|
72620543|NCT02037984|144772313|OTHER|PT4 GMC Ratio (V114/Prevnar 13®)|PT4 GMG Ratio|0.87|||||TWO_SIDED|95.0|0.65|1.16||||||||1.16|0.65|
72620544|NCT02037984|144772313|OTHER|PT5 GMC Ratio (V114/Prevnar 13®)|PT5 GMC Ratio|0.51|||||TWO_SIDED|95.0|0.35|0.74||||||||0.74|0.35|
72620545|NCT02037984|144772313|OTHER|PT6A GMC Ratio (V114/Prevnar 13®)|PT6A GMC Ratio|0.31|||||TWO_SIDED|95.0|0.17|0.58||||||||0.58|0.17|
72455249|NCT00487240|144433769|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.03||||0.718||95.0|-0.22|0.15||P-value for 8 Week Change from Baseline.|ANCOVA|ANCOVA Model: Variable=Treatment+Baseline+Country.|Least Squares Mean Difference=Insulin Lispro Protamine Suspension minus Detemir.|||0.15|-0.22|0.718
72455250|NCT00487240|144433769|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.14||||0.187||95.0|-0.34|0.07||P-value for 16 Week Change from Baseline.|ANCOVA|ANCOVA Model: Variable=Treatment+Baseline+Country|Least Squares Mean Difference = Insulin Lispro Protamine Suspension minus Detemir.|||0.07|-0.34|0.187
72455251|NCT00487240|144433769|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.04||||0.704||95.0|-0.25|0.17||P-value for 24 Week Change from Baseline.|ANCOVA|ANCOVA Model: Variable=Treatment+Baseline+Country|Least Squares Mean Difference = Insulin Lispro Protamine Suspension minus Detemir.|||0.17|-0.25|0.704
72455252|NCT00487240|144433769|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.06||||0.599||95.0|-0.27|0.15||P-value for 32 Week Change from Baseline.|ANCOVA|ANCOVA Model: Variable=Treatment+Baseline+Country|Least Squares Mean Difference = Insulin Lispro Protamine Suspension minus Detemir.|||0.15|-0.27|0.599
72455253|NCT00487240|144433770|SUPERIORITY_OR_OTHER|||||||1||95.0||||P-value for With HbA1c ≤7.0%.|Fisher Exact|||||||1.000
72455254|NCT00487240|144433770|SUPERIORITY_OR_OTHER|||||||1||95.0||||P-value for With HbA1c \<7.0%|Fisher Exact|||||||1.000
72455255|NCT00487240|144433770|SUPERIORITY_OR_OTHER|||||||0.722||95.0||||P-value for With HbA1c ≤6.5%|Fisher Exact|||||||0.722
72455256|NCT00487240|144433770|SUPERIORITY_OR_OTHER|||||||0.699||95.0||||P-value for With HbA1c \<6.5%|Fisher Exact|||||||0.699
72455257|NCT00487240|144433771|SUPERIORITY_OR_OTHER|||||||0.259||95.0||||P-value for Daily Mean 7-Point SMBG.|ANCOVA|ANCOVA Model: Variable=Treatment+Baseline+Country||||||0.259
72455258|NCT00487240|144433771|SUPERIORITY_OR_OTHER|||||||0.468||95.0||||P-value for Daily Mean Pre-Meal|ANCOVA|ANCOVA Model: Variable=Treatment+Baseline+Country||||||0.468
72455259|NCT00487240|144433771|SUPERIORITY_OR_OTHER|||||||0.395||95.0||||P-value for Daily Mean Postprandial Meal|ANCOVA|ANCOVA Model: Variable=Treatment+Baseline+Country||||||0.395
72455260|NCT00487240|144433771|SUPERIORITY_OR_OTHER|||||||0.414||95.0||||P-value for Daily Mean Morning and Evening Pre-Meal|ANCOVA|ANCOVA Model: Variable=Treatment+Baseline+Country||||||0.414
72391879|NCT00256750|144290860|NON_INFERIORITY_OR_EQUIVALENCE|A non-inferiority margin of 10% for the co-primary endpoint of participant and graft survival was used. Determination of a margin for non-inferiority based on 'preservation of benefit' is not feasible, given the low rate of patient death and/or graft loss in the first year post-transplantation, and the absence of published, adequately sized, parallel-group trials with which to assess the effect of CsA on patient death and/or graft loss in the setting of MMF/steroids/basiliximab.|Difference in Percent|3.3|||||TWO_SIDED|97.3|-2.9|9.8||||||Month 36||9.8|-2.9|
72455261|NCT00487240|144433771|SUPERIORITY_OR_OTHER|||||||0.275||95.0||||P-value for Actual Morning Pre-Meal|ANCOVA|ANCOVA Model: Variable=Treatment+Baseline+Country||||||0.275
72499938|NCT00190775|144530106|SUPERIORITY_OR_OTHER|||||||0.214||95.0||||P-Value for Affectional Expression.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.214
72455262|NCT00487240|144433771|SUPERIORITY_OR_OTHER|||||||0.611||95.0||||P-value for Actual Morning Postprandial Meal|ANCOVA|ANCOVA Model: Variable=Treatment+Baseline+Country||||||0.611
72455263|NCT00487240|144433771|SUPERIORITY_OR_OTHER|||||||0.763||95.0||||P-value for Actual Midday Pre-Meal|ANCOVA|ANCOVA Model: Variable=Treatment+Baseline+Country||||||0.763
72455264|NCT00487240|144433771|SUPERIORITY_OR_OTHER|||||||0.977||95.0||||P-value for Actual Midday Postprandial Meal|ANCOVA|ANCOVA Model: Variable=Treatment+Baseline+Country||||||0.977
72455265|NCT00487240|144433771|SUPERIORITY_OR_OTHER|||||||0.586||95.0||||P-value for Actual Evening Pre-Meal|ANCOVA|ANCOVA Model: Variable=Treatment+Baseline+Country||||||0.586
72455266|NCT00487240|144433771|SUPERIORITY_OR_OTHER|||||||0.093||95.0||||P-value for Actual Evening Postprandial Meal|ANCOVA|ANCOVA Model: Variable=Treatment+Baseline+Country||||||0.093
72455267|NCT00487240|144433771|SUPERIORITY_OR_OTHER|||||||0.516||95.0||||P-value for Actual 0300 Hours|ANCOVA|ANCOVA Model: Variable=Treatment+Baseline+Country||||||0.516
72455268|NCT00487240|144433771|SUPERIORITY_OR_OTHER|||||||0.576||95.0||||P-value for Actual Morning SMBG Excursion|ANCOVA|ANCOVA Model: Variable=Treatment+Baseline+Country||||||0.576
72455269|NCT00487240|144433771|SUPERIORITY_OR_OTHER|||||||0.876||95.0||||P-value for Midday SMBG Excursion|ANCOVA|ANCOVA Model: Variable=Treatment+Baseline+Country||||||0.876
72455270|NCT00487240|144433771|SUPERIORITY_OR_OTHER|||||||0.261||95.0||||P-value for Evening SMBG Excursion|ANCOVA|ANCOVA Model: Variable=Treatment+Baseline+Country||||||0.261
72455271|NCT00487240|144433771|SUPERIORITY_OR_OTHER|||||||0.567||95.0||||P-value for Daily Mean SMBG Excursion|ANCOVA|ANCOVA Model: Variable=Treatment+Baseline+Country||||||0.567
72455272|NCT00487240|144433772|NON_INFERIORITY_OR_EQUIVALENCE|A noninferiority margin of 0.8 mmol/L was chosen to prove noninferiority of ILPS to detemir.|Mean Difference (Net)|0.36||||||95.0|-0.03|0.75|||||Least Squares Mean difference = Insulin Lispro Protamine Suspension - Detemir|If the primary analysis achieves statistical significance at a 0.05 level (that is, the null hypothesis for the primary analysis \[primary outcome measure\] is rejected), then the first secondary hypothesis (glycemic variability) is tested at an error rate of 0.05.||0.75|-0.03|
72455273|NCT00487240|144433772|SUPERIORITY_OR_OTHER|||||||0.132||95.0||||P-value for M-Value|ANCOVA|ANCOVA Model: Variable=Treatment+Baseline+Country||||||0.132
72455274|NCT00487240|144433772|SUPERIORITY_OR_OTHER|||||||0.179||95.0||||P-value for MODD|ANCOVA|ANCOVA Model: Variable=Treatment+Baseline+Country||||||0.179
72455275|NCT00487240|144433773|SUPERIORITY_OR_OTHER|||||||0.737||95.0||||P-value for Endpoint Hypoglycemic Episodes|Fisher Exact|||||||0.737
72455276|NCT00487240|144433773|SUPERIORITY_OR_OTHER|||||||0.724||95.0||||P-value for Overall Hypoglycemic Episodes|Fisher Exact|||||||0.724
72455277|NCT00487240|144433773|SUPERIORITY_OR_OTHER|||||||0.157||95.0||||P-value for Endpoint Nocturnal Hypoglycemic Episodes|Fisher Exact|||||||0.157
72455278|NCT00487240|144433773|SUPERIORITY_OR_OTHER|||||||0.287||95.0||||P-value for Overall Nocturnal Episodes|Fisher Exact|||||||0.287
72499939|NCT00190775|144530106|SUPERIORITY_OR_OTHER|||||||0.543||95.0||||P-Value for Dyadic Cohesion.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.543
72620546|NCT02037984|144772313|OTHER|PT6B GMC Ratio (V114/Prevnar 13®)|PT6B GMG Ratio|0.16|||||TWO_SIDED|95.0|0.08|0.34||||||||0.34|0.08|
72620547|NCT02037984|144772313|OTHER|PT7F GMC Ratio (V114/Prevnar 13®)|PT7F GMC Ratio|0.48|||||TWO_SIDED|95.0|0.34|0.67||||||||0.67|0.34|
72620548|NCT02037984|144772313|OTHER|PT9V GMC Ratio (V114/Prevnar 13®)|PT9V GMC Ratio|0.56|||||TWO_SIDED|95.0|0.39|0.82||||||||0.82|0.39|
72620549|NCT02037984|144772313|OTHER|PT14 GMC Ratio (V114/Prevnar®)|PT9V GMC Ratio|0.64|||||TWO_SIDED|95.0|0.42|0.97||||||||0.97|0.42|
72620550|NCT02037984|144772313|OTHER|PT18C GMC Ratio (V114/Prevnar 13®)|PT18C GMC Ratio|0.85|||||TWO_SIDED|95.0|0.6|1.21||||||||1.21|0.60|
72620551|NCT02037984|144772313|OTHER|PT19A GMC Ratio (V114/Prevnar 13®)|PT19A GMC Ratio|0.66|||||TWO_SIDED|95.0|0.46|0.95||||||||0.95|0.46|
72620552|NCT02037984|144772313|OTHER|PT19F GMC Ratio (V114/Prevnar 13®)|PT19F GMC Ratio|1.11|||||TWO_SIDED|95.0|0.77|1.6||||||||1.60|0.77|
72620553|NCT02037984|144772313|OTHER|PT23F GMC Ratio (V114/Prevnar 13®)|PT23F GMC Ratio|0.68|||||TWO_SIDED|95.0|0.43|1.07||||||||1.07|0.43|
72620554|NCT02037984|144772313|OTHER|non-PT22F GMC Ratio (V114/Prevnar 13®)|non-PT22F GMC Ratio|44.61|||||TWO_SIDED|95.0|30.42|65.43||||||||65.43|30.42|
72455279|NCT00487240|144433773|SUPERIORITY_OR_OTHER|||||||0.664||95.0||||P-value for Endpoint Non-Nocturnal Hypoglycemic Episodes|Fisher Exact|||||||0.664
72455280|NCT00487240|144433773|SUPERIORITY_OR_OTHER|||||||0.73||95.0||||P-value for Overall Non-Nocturnal Hypoglycemic Episodes|Fisher Exact|||||||0.730
72620555|NCT02037984|144772313|OTHER|non-PT33F GMC Ratio (V114/Prevnar 13®)|non-PT33F GMC Ratio|15.29|||||TWO_SIDED|95.0|8.58|27.26||||||||27.26|8.58|
72620556|NCT02037984|144772314|OTHER|PT1 GMC Ratio (V114/Prevnar 13®)|PT1 GMC Ratio|0.78|||||TWO_SIDED|95.0|0.57|1.07||||||||1.07|0.57|
72620557|NCT02037984|144772314|OTHER|PT3 GMC Ratio (V114/Prevnar 13®)|PT3 GMC Ratio|2.68|||||TWO_SIDED|95.0|1.95|3.68||||||||3.68|1.95|
72455281|NCT00487240|144433773|SUPERIORITY_OR_OTHER|||||||0.053||95.0||||P-value for Endpoint Severe Hypoglycemic Episodes|Fisher Exact|||||||0.053
72620558|NCT02037984|144772314|OTHER|PT4 GMC Ratio (V114/Prevnar 13®)|PT4 GMG Ratio|1.52|||||TWO_SIDED|95.0|1.11|2.07||||||||2.07|1.11|
72620559|NCT02037984|144772314|OTHER|PT5 GMC Ratio (V114/Prevnar 13®)|PT5 GMC Ratio|0.68|||||TWO_SIDED|95.0|0.46|1.02||||||||1.02|0.46|
72620560|NCT02037984|144772314|OTHER|PT6A GMC Ratio (V114/Prevnar 13®)|PT6A GMC Ratio|0.33|||||TWO_SIDED|95.0|0.17|0.64||||||||0.64|0.17|
72620561|NCT02037984|144772314|OTHER|PT6B GMC Ratio (V114/Prevnar 13®)|PT6B GMG Ratio|0.11|||||TWO_SIDED|95.0|0.05|0.23||||||||0.23|0.05|
72455282|NCT00487240|144433773|SUPERIORITY_OR_OTHER|||||||0.081||95.0||||P-value for Overall Severe Hypoglycemic Episodes|Fisher Exact|||||||0.081
72455283|NCT00487240|144433774|SUPERIORITY_OR_OTHER|||||||0.28||95.0||||P-value for Endpoint Hypoglycemic Rate|ANCOVA|ANCOVA Model: Variable=Treatment+Baseline+Country. Hypoglycemic Rate (Adjusted for 1 year) was used in the analysis.||||||0.280
72455284|NCT00487240|144433774|SUPERIORITY_OR_OTHER|||||||0.193||95.0||||P-value for Overall Hypoglycemic Rate|ANCOVA|ANCOVA Model: Variable=Treatment+Baseline+Country. Hypoglycemic Rate (Adjusted for 1 year) was used in the analysis.||||||0.193
72455285|NCT00487240|144433774|SUPERIORITY_OR_OTHER|||||||0.042||95.0||||P-value for Endpoint Nocturnal Hypoglycemic Rate|ANCOVA|ANCOVA Model: Variable=Treatment+Baseline+Country. Hypoglycemic Rate (Adjusted for 1 year) was used in the analysis.||||||0.042
72455286|NCT00487240|144433774|SUPERIORITY_OR_OTHER|||||||0.001||95.0||||P-value for Overall Nocturnal Hypoglycemic Rate|ANCOVA|ANCOVA Model: Variable=Treatment+Baseline+Country. Hypoglycemic Rate (Adjusted for 1 year) was used in the analysis.||||||0.001
72620562|NCT02037984|144772314|OTHER|PT7F GMC Ratio (V114/Prevnar 13®)|PT7F GMC Ratio|0.73|||||TWO_SIDED|95.0|0.51|1.04||||||||1.04|0.51|
72620563|NCT02037984|144772314|OTHER|PT9V GMC Ratio (V114/Prevnar 13®)|PT9V GMC Ratio|0.88|||||TWO_SIDED|95.0|0.59|1.3||||||||1.30|0.59|
72620564|NCT02037984|144772314|OTHER|PT14 GMC Ratio (V114/Prevnar®)|PT9V GMC Ratio|1.03|||||TWO_SIDED|95.0|0.66|1.6||||||||1.60|0.66|
72620565|NCT02037984|144772314|OTHER|PT18C GMC Ratio (V114/Prevnar 13®)|PT18C GMC Ratio|0.96|||||TWO_SIDED|95.0|0.66|1.39||||||||1.39|0.66|
72620566|NCT02037984|144772314|OTHER|PT19A GMC Ratio (V114/Prevnar 13®)|PT19A GMC Ratio|0.95|||||TWO_SIDED|95.0|0.64|1.39||||||||1.39|0.64|
72620567|NCT02037984|144772314|OTHER|PT19F GMC Ratio (V114/Prevnar 13®)|PT19F GMC Ratio|1.24|||||TWO_SIDED|95.0|0.84|1.84||||||||1.84|0.84|
72620568|NCT02037984|144772314|OTHER|PT23F GMC Ratio (V114/Prevnar 13®)|PT23F GMC Ratio|0.75|||||TWO_SIDED|95.0|0.46|1.23||||||||1.23|0.46|
72620569|NCT02037984|144772314|OTHER|non-PT22F GMC Ratio (V114/Prevnar 13®)|non-PT22F GMC Ratio|77.57|||||TWO_SIDED|95.0|51.6|116.6||||||||116.60|51.60|
72620570|NCT02037984|144772314|OTHER|non-PT33F GMC Ratio (V114/Prevnar 13®)|non-PT33F GMC Ratio|15.66|||||TWO_SIDED|95.0|8.46|28.98||||||||28.98|8.46|
72620571|NCT02037984|144772315|OTHER|PT1 GMC Ratio (V114/Prevnar 13®)|PT1 GMC Ratio|0.68|||||TWO_SIDED|95.0|0.5|0.93||||||||0.93|0.50|
72620572|NCT02037984|144772315|OTHER|PT3 GMC Ratio (V114/Prevnar 13®)|PT3 GMC Ratio|2.21|||||TWO_SIDED|95.0|1.62|3.02||||||||3.02|1.62|
72620573|NCT02037984|144772315|OTHER|PT4 GMC Ratio (V114/Prevnar 13®)|PT4 GMG Ratio|0.97|||||TWO_SIDED|95.0|0.71|1.31||||||||1.31|0.71|
72620574|NCT02037984|144772315|OTHER|PT5 GMC Ratio (V114/Prevnar 13®)|PT5 GMC Ratio|0.53|||||TWO_SIDED|95.0|0.36|0.79||||||||0.79|0.36|
72620575|NCT02037984|144772315|OTHER|PT6A GMC Ratio (V114/Prevnar 13®)|PT6A GMC Ratio|0.49|||||TWO_SIDED|95.0|0.26|0.94||||||||0.94|0.26|
72620576|NCT02037984|144772315|OTHER|PT6B GMC Ratio (V114/Prevnar 13®)|PT6B GMG Ratio|0.36|||||TWO_SIDED|95.0|0.17|0.77||||||||0.77|0.17|
72620577|NCT02037984|144772315|OTHER|PT7F GMC Ratio (V114/Prevnar 13®)|PT7F GMC Ratio|0.6|||||TWO_SIDED|95.0|0.42|0.85||||||||0.85|0.42|
72620578|NCT02037984|144772315|OTHER|PT9V GMC Ratio (V114/Prevnar 13®)|PT9V GMC Ratio|0.79|||||TWO_SIDED|95.0|0.54|1.16||||||||1.16|0.54|
72620579|NCT02037984|144772315|OTHER|PT14 GMC Ratio (V114/Prevnar®)|PT9V GMC Ratio|0.74|||||TWO_SIDED|95.0|0.48|1.14||||||||1.14|0.48|
72620580|NCT02037984|144772315|OTHER|PT18C GMC Ratio (V114/Prevnar 13®)|PT18C GMC Ratio|0.66|||||TWO_SIDED|95.0|0.46|0.95||||||||0.95|0.46|
72620581|NCT02037984|144772315|OTHER|PT19A GMC Ratio (V114/Prevnar 13®)|PT19A GMC Ratio|0.7|||||TWO_SIDED|95.0|0.48|1.02||||||||1.02|0.48|
72620582|NCT02037984|144772315|OTHER|PT19F GMC Ratio (V114/Prevnar 13®)|PT19F GMC Ratio|0.88|||||TWO_SIDED|95.0|0.6|1.29||||||||1.29|0.60|
72620583|NCT02037984|144772315|OTHER|PT23F GMC Ratio (V114/Prevnar 13®)|PT23F GMC Ratio|0.69|||||TWO_SIDED|95.0|0.43|1.12||||||||1.12|0.43|
72620584|NCT02037984|144772315|OTHER|non-PT22F GMC Ratio (V114/Prevnar 13®)|non-PT22F GMC Ratio|56.08|||||TWO_SIDED|95.0|37.66|83.52||||||||83.52|37.66|
72620585|NCT02037984|144772315|OTHER|non-PT33F GMC Ratio (V114/Prevnar 13®)|non-PT33F GMC Ratio|25.75|||||TWO_SIDED|95.0|14.18|46.78||||||||46.78|14.18|
72620586|NCT02037984|144772316|OTHER|PT1 GMC Ratio (V114/Prevnar 13®)|PT1 GMC Ratio|0.8|||||TWO_SIDED|95.0|0.58|1.09||||||||1.09|0.58|
72620587|NCT02037984|144772316|OTHER|PT3 GMC Ratio (V114/Prevnar 13®)|PT3 GMC Ratio|2.55|||||TWO_SIDED|95.0|1.86|3.49||||||||3.49|1.86|
72620588|NCT02037984|144772316|OTHER|PT4 GMC Ratio (V114/Prevnar 13®)|PT4 GMG Ratio|1.07|||||TWO_SIDED|95.0|0.79|1.46||||||||1.46|0.79|
72620589|NCT02037984|144772316|OTHER|PT5 GMC Ratio (V114/Prevnar 13®)|PT5 GMC Ratio|0.51|||||TWO_SIDED|95.0|0.34|0.76||||||||0.76|0.34|
72620590|NCT02037984|144772316|OTHER|PT6A GMC Ratio (V114/Prevnar 13®)|PT6A GMC Ratio|0.34|||||TWO_SIDED|95.0|0.17|0.65||||||||0.65|0.17|
72620591|NCT02037984|144772316|OTHER|PT6B GMC Ratio (V114/Prevnar 13®)|PT6B GMG Ratio|0.18|||||TWO_SIDED|95.0|0.08|0.38||||||||0.38|0.08|
72620592|NCT02037984|144772316|OTHER|PT7F GMC Ratio (V114/Prevnar 13®)|PT7F GMC Ratio|0.59|||||TWO_SIDED|95.0|0.41|0.84||||||||0.84|0.41|
72620593|NCT02037984|144772316|OTHER|PT9V GMC Ratio (V114/Prevnar 13®)|PT9V GMC Ratio|0.68|||||TWO_SIDED|95.0|0.46|1.01||||||||1.01|0.46|
72620594|NCT02037984|144772316|OTHER|PT14 GMC Ratio (V114/Prevnar®)|PT9V GMC Ratio|0.79|||||TWO_SIDED|95.0|0.51|1.22||||||||1.22|0.51|
72620595|NCT02037984|144772316|OTHER|PT18C GMC Ratio (V114/Prevnar 13®)|PT18C GMC Ratio|0.72|||||TWO_SIDED|95.0|0.5|1.05||||||||1.05|0.50|
72620596|NCT02037984|144772316|OTHER|PT19A GMC Ratio (V114/Prevnar 13®)|PT19A GMC Ratio|0.55|||||TWO_SIDED|95.0|0.37|0.8||||||||0.80|0.37|
72620597|NCT02037984|144772316|OTHER|PT19F GMC Ratio (V114/Prevnar 13®)|PT19F GMC Ratio|0.97|||||TWO_SIDED|95.0|0.66|1.44||||||||1.44|0.66|
72620598|NCT02037984|144772316|OTHER|PT23F GMC Ratio (V114/Prevnar 13®)|PT23F GMC Ratio|0.79|||||TWO_SIDED|95.0|0.49|1.28||||||||1.28|0.49|
72620599|NCT02037984|144772316|OTHER|non-PT22F GMC Ratio (V114/Prevnar 13®)|non-PT22F GMC Ratio|68.64|||||TWO_SIDED|95.0|45.81|102.84||||||||102.84|45.81|
72620600|NCT02037984|144772316|OTHER|non-PT33F GMC Ratio (V114/Prevnar 13®)|non-PT33F GMC Ratio|20.03|||||TWO_SIDED|95.0|10.88|36.88||||||||36.88|10.88|
72620601|NCT02037984|144772320|OTHER|PT1 Percentage Point Difference (V114 - Prevnar 13®)|PT1 Percentage Point Difference|-3.2|||||TWO_SIDED|95.0|-16.3|6.5|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||6.5|-16.3|
72620602|NCT02037984|144772320|OTHER|PT3 Percentage Point Difference (V114 - Prevnar 13®)|PT3 Percentage Point Difference|14.6|||||TWO_SIDED|95.0|-4.1|32.5|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||32.5|-4.1|
72455287|NCT00487240|144433774|SUPERIORITY_OR_OTHER|||||||0.579||95.0||||P-value for Endpoint Non-Nocturnal Hypoglycemic Rate|ANCOVA|ANCOVA Model: Variable=Treatment+Baseline+Country. Hypoglycemic Rate (Adjusted for 1 year) was used in the analysis.||||||0.579
72455288|NCT00487240|144433774|SUPERIORITY_OR_OTHER|||||||0.531||95.0||||P-value for Overall Non-Nocturnal Hypoglycemic Rate|ANCOVA|ANCOVA Model: Variable=Treatment+Baseline+Country. Hypoglycemic Rate (Adjusted for 1 year) was used in the analysis.||||||0.531
72620603|NCT02037984|144772320|OTHER|PT4 Percentage Point Difference (V114 - Prevnar 13®)|PT4 Percentage Point Difference|-7.0|||||TWO_SIDED|95.0|-22.8|5.7|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||5.7|-22.8|
72620604|NCT02037984|144772320|OTHER|PT5 Percentage Point Difference (V114 - Prevnar 13®)|PT5 Percentage Point Difference|0.0|||||TWO_SIDED|95.0|-11.2|9.5|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||9.5|-11.2|
72455289|NCT00487240|144433774|SUPERIORITY_OR_OTHER|||||||0.017||95.0||||P-value for Endpoint Severe Hypoglycemic Rate|ANCOVA|ANCOVA Model: Variable=Treatment+Baseline+Country. Hypoglycemic Rate (Adjusted for 1 year) was used in the analysis.||||||0.017
72620605|NCT02037984|144772320|OTHER|PT6A Percentage Point Difference (V114 - Prevnar 13®)|PT6A Percentage Point Difference|0.0|||||TWO_SIDED|95.0|-11.2|9.5|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||9.5|-11.2|
72620606|NCT02037984|144772320|OTHER|PT6B Percentage Point Difference (V114 - Prevnar 13®)|PT6B Percentage Point Difference|0.0|||||TWO_SIDED|95.0|-11.2|9.5|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||9.5|-11.2|
72620607|NCT02037984|144772320|OTHER|PT7F Percentage Point Difference (V114 - Prevnar 13®)|PT7F Percentage Point Difference|0.0|||||TWO_SIDED|95.0|-11.2|9.5|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||9.5|-11.2|
72620608|NCT02037984|144772320|OTHER|PT9V Percentage Point Difference (V114 - Prevnar 13®)|PT9V Percentage Point Difference|0.0|||||TWO_SIDED|95.0|-11.2|9.5|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||9.5|-11.2|
72620609|NCT02037984|144772320|OTHER|PT14 Percentage Point Difference (V114 - Prevnar 13®)|PT14 Percentage Point Difference|0.0|||||TWO_SIDED|95.0|-11.2|9.5|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||9.5|-11.2|
72620610|NCT02037984|144772320|OTHER|PT18C Percentage Point Difference (V114 - Prevnar 13®)|PT18C Percentage Point Difference|0.0|||||TWO_SIDED|95.0|-11.2|9.5|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||9.5|-11.2|
72620611|NCT02037984|144772320|OTHER|PT19A Percentage Point Difference (V114 - Prevnar 13®)|PT19A Percentage Point Difference|0.0|||||TWO_SIDED|95.0|-11.2|9.5|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||9.5|-11.2|
72620612|NCT02037984|144772320|OTHER|PT19F Percentage Point Difference (V114 - Prevnar 13®)|PT19F Percentage Point Difference|0.0|||||TWO_SIDED|95.0|-11.2|9.5|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||9.5|-11.2|
72620613|NCT02037984|144772320|OTHER|PT23F Percentage Point Difference (V114 - Prevnar 13®)|PT23F Percentage Point Difference|0.0|||||TWO_SIDED|95.0|-11.2|9.5|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||9.5|-11.2|
72620614|NCT02037984|144772320|OTHER|non-PT22F Percentage Point Difference (V114 - Prevnar 13®)|non-PT22F Percentage Point Difference|89.2|||||TWO_SIDED|95.0|75.2|95.7|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||95.7|75.2|
72620615|NCT02037984|144772320|OTHER|non-PT33F Percentage Point Difference (V114 - Prevnar 13®)|non-PT33F Percentage Point Difference|97.3|||||TWO_SIDED|95.0|85.1|99.5|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||99.5|85.1|
72620616|NCT02037984|144772321|OTHER|PT1 Percentage Point Difference (V114 - Prevnar 13®)|PT1 Percentage Point Difference|-4.2|||||TWO_SIDED|95.0|-20.4|5.6|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||5.6|-20.4|
72620617|NCT02037984|144772321|OTHER|PT3 Percentage Point Difference (V114 - Prevnar 13®)|PT3 Percentage Point Difference|11.8|||||TWO_SIDED|95.0|-10.0|30.6|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||30.6|-10.0|
72620618|NCT02037984|144772321|OTHER|PT4 Percentage Point Difference (V114 - Prevnar 13®)|PT4 Percentage Point Difference|-1.6|||||TWO_SIDED|95.0|-18.8|10.3|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||10.3|-18.8|
72455290|NCT00487240|144433774|SUPERIORITY_OR_OTHER|||||||0.038||95.0||||P-value for Overall Severe Hypoglycemic Rate|ANCOVA|ANCOVA Model: Variable=Treatment+Baseline+Country. Hypoglycemic Rate (Adjusted for 1 year) was used in the analysis.||||||0.038
72455291|NCT00487240|144433776|NON_INFERIORITY_OR_EQUIVALENCE|A noninferiority margin of 1.5 kg was chosen to prove noninferiority of ILPS to detemir.|Mean Difference (Net)|0.97||||0.003||95.0|0.34|1.6||P-value for Change from Baseline.|ANCOVA|ANCOVA Model: Variable=Treatment+Baseline+Country.|Least Squares Mean Difference = Insulin Lispro Protamine Suspension minus Detemir.|If the first secondary null hypothesis (glycemic variability) is rejected, then the second secondary hypothesis (weight change) is tested at an error rate of 0.05.||1.60|0.34|0.003
72620619|NCT02037984|144772321|OTHER|PT5 Percentage Point Difference (V114 - Prevnar 13®)|PT5 Percentage Point Difference|0.0|||||TWO_SIDED|95.0|-14.0|9.6|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||9.6|-14.0|
72620620|NCT02037984|144772321|OTHER|PT6A Percentage Point Difference (V114 - Prevnar 13®)|PT6A Percentage Point Difference|0.0|||||TWO_SIDED|95.0|-14.5|9.6|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||9.6|-14.5|
72455292|NCT00487240|144433777|SUPERIORITY_OR_OTHER|||||||0.023||95.0||||P-value for Total Insulin|ANOVA|ANOVA Model: Variable=Treatment+Country||||||0.023
72455293|NCT00487240|144433777|SUPERIORITY_OR_OTHER|||||||0.004||95.0||||P-value for Total Bolus Insulin|ANOVA|ANOVA Model: Variable=Treatment+Country||||||0.004
72455294|NCT00487240|144433777|SUPERIORITY_OR_OTHER|||||||0.282||95.0||||P-value for Total Basal Insulin|ANOVA|ANOVA Model: Variable=Treatment+Country||||||0.282
72455295|NCT00487240|144433778|SUPERIORITY_OR_OTHER|||||||0.82||95.0||||P-value for Total Insulin|ANOVA|ANOVA Model: Variable=Treatment+Country||||||0.82
72455296|NCT00487240|144433778|SUPERIORITY_OR_OTHER|||||||0.19||95.0||||P-value for Total Bolus Insulin|ANOVA|ANOVA Model: Variable=Treatment+Country||||||0.19
72455297|NCT00487240|144433778|SUPERIORITY_OR_OTHER|||||||0.416||95.0||||P-value for Total Basal Insulin|ANOVA|ANOVA Model: Variable=Treatment+Country||||||0.416
72455298|NCT05553366|144433850|SUPERIORITY|||||||0.0002|||||||ANCOVA|||||||0.0002
72455299|NCT05553366|144433851|SUPERIORITY|||||||0.0016|||||||ANCOVA|||||||0.0016
72455300|NCT05553366|144433852|SUPERIORITY|||||||0.0016|||||||Log Rank|||||||0.0016
72455301|NCT05553366|144433853|SUPERIORITY|||||||0.1315|||||||Log Rank|||||||0.1315
72455302|NCT05553366|144433854|SUPERIORITY|||||||0.0343|||||||Cochran-Mantel-Haenszel|||||||0.0343
72455303|NCT05553366|144433855|SUPERIORITY|||||||0.0014|||||||Pearson's chi-squared test|||||||0.0014
72455304|NCT05553366|144433856|SUPERIORITY|||||||0.0032|||||||ANCOVA|||||||0.0032
72620621|NCT02037984|144772321|OTHER|PT6B Percentage Point Difference (V114 - Prevnar 13®)|PT6B Percentage Point Difference|0.0|||||TWO_SIDED|95.0|-14.5|9.6|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||9.6|-14.5|
72455305|NCT05553366|144433857|SUPERIORITY|||||||0.8592|||||||Log Rank|||||||0.8592
72455306|NCT05553366|144433858|SUPERIORITY|||||||0.9143|||||||Cochran-Mantel-Haenszel|||||||0.9143
72455307|NCT05553366|144433859|SUPERIORITY|||||||0.0205|||||||Wilcoxon rank-sum|||||||0.0205
72455308|NCT00659373|144433946|SUPERIORITY_OR_OTHER|||||||0.71|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.71
72455309|NCT02356198|144433955|SUPERIORITY|||||||0.007|||||||t-test, 2 sided|||||||0.007
72455310|NCT02356198|144433956|SUPERIORITY|||||||0.102|||||||Wilcoxon (Mann-Whitney)|||||||0.102
72455311|NCT02356198|144433957|SUPERIORITY|||||||0.85|||||||Wilcoxon (Mann-Whitney)|||||||0.85
72455312|NCT02356198|144433958|SUPERIORITY|||||||0.454|||||||Chi-squared|||||||0.454
72455313|NCT02356198|144433959|SUPERIORITY|||||||0.212|||||||Fisher Exact|||||||0.212
72455314|NCT03162614|144433960|OTHER|Vaccine efficacy rate was calculated as 100\*(1-RR) with RR=relative risk of developing the disease for vaccinated people compared to unvaccinated people.|Vaccine efficacy rate|55.0|||<|0.001|TWO_SIDED|95.0|27.0|72.0|||Fisher Exact|||Efficacy analysis aimed at comparing RTS,S/AS01B administered as full doses at Month 0 and Month 1 and 1/5th dose at Month 7 (AduFx Group versus Control Group).||72|27|<.001
72455315|NCT03162614|144433960|OTHER|Vaccine efficacy rate was calculated as 100\*(1-RR) with RR=relative risk of developing the disease for vaccinated people compared to unvaccinated people.|Vaccine efficacy rate|76.0|||<|0.001|TWO_SIDED|95.0|49.0|89.0|||Fisher Exact|||Efficacy analysis aimed at comparing RTS,S/AS01E administered as double full doses at Month 0 and Month 1 and 1/5th double dose at Month 7 (2Ped Fx Group versus Control Group).||89|49|<.001
72455316|NCT03162614|144433960|OTHER|Vaccine efficacy rate was calculated as 100\*(1-RR) with RR=relative risk of developing the disease for vaccinated people compared to unvaccinated people.|Vaccine efficacy rate|64.0|||<|0.001|TWO_SIDED|95.0|37.0|79.0|||Fisher Exact|||Efficacy analysis aimed at comparing RTS,S/AS01E administered as full doses at Month 0 and Month 1 and 1/5th dose at Month 7 (PedFx Group versus Control Group).||79|37|<.001
72455317|NCT03162614|144433960|OTHER|Vaccine efficacy rate was calculated as 100\*(1-RR) with RR=relative risk of developing the disease for vaccinated people compared to unvaccinated people.|Vaccine efficacy rate|55.0|||<|0.001|TWO_SIDED|95.0|27.0|72.0|||Fisher Exact|||Efficacy analysis aimed at comparing RTS,S/AS01B administered as full dose at Month 0 and 1/5th dose at Month 1 and Month 7 (Adu2Fx Group versus Control Group).||72|27|<.001
72455318|NCT03162614|144433960|OTHER|Vaccine efficacy rate was calculated as 100\*(1-RR) with RR=relative risk of developing the disease for vaccinated people compared to unvaccinated people.|Vaccine efficacy rate|29.0||||0.009|TWO_SIDED|95.0|6.0|46.0|||Fisher Exact|||Efficacy analysis aimed at comparing RTS,S/AS01B administered as full dose at Month 0 and 1/5th dose at Month 7 (Adu1Fx Group versus Control Group).||46|6|0.009
72455319|NCT01321073|144434010|SUPERIORITY||||||<|0.0001|||||||1-sample exact test for Poisson rate|||The rate of catheter-related complications per 1000 patient-days was compared to a pre-specified value of 2.5 / 1000 days. This was calculated based on published complication rates in PAH that included central venous catheter systemic bloodstream infections (0.43-1.13), site infections (0.26-0.87), and complications from catheter thrombosis, mechanical dysfunction, or catheter dislocation in the general central venous catheter population (0.36-0.51). The sum of the upper rates is 2.5.||||<0.0001
72620622|NCT02037984|144772321|OTHER|PT7F Percentage Point Difference (V114 - Prevnar 13®)|PT7F Percentage Point Difference|0.0|||||TWO_SIDED|95.0|-14.0|9.6|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||9.6|-14.0|
72620623|NCT02037984|144772321|OTHER|PT9V Percentage Point Difference (V114 - Prevnar 13®)|PT9V Percentage Point Difference|0.0|||||TWO_SIDED|95.0|-14.0|9.6|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||9.6|-14.0|
72455320|NCT00145470|144434053|SUPERIORITY|||||||0.0257||||||P-value based on the difference in the least squares (LS) means for asenapine versus placebo.|ANCOVA|Based on an ANCOVA model with treatment and pooled investigative site as fixed effects and baseline as a covariate.||Change from Baseline at Day 21||||0.0257
72455321|NCT00145470|144434056|SUPERIORITY|||||||0.021||||||P-value based on the difference in the LS means for asenapine versus placebo.|ANCOVA|Based on an ANCOVA model with treatment and pooled investigative site as fixed effects and baseline as a covariate.||Change from Baseline at Day 42||||0.0210
72455322|NCT00145470|144434057|SUPERIORITY|||||||0.0073||||||P-value based on the difference in the LS means for asenapine versus placebo.|ANCOVA|Based on an ANCOVA model with treatment and pooled investigative site as fixed effects and baseline as a covariate.||Change from Baseline at Day 84||||0.0073
72499940|NCT00190775|144530107|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.28|STANDARD_ERROR_OF_MEAN|1.05||0.001||95.0|||||Mixed Models Analysis|Model included visit, baseline, treatment, pooled investigator, child with ADHD, and treatment by visit.|Least Squares Mean Difference = Atomoxetine - Placebo.|Approximately 500 participants were randomized to atomoxetine or placebo (1:1) which provided at least 90% power to detect a treatment difference of 3.64 points on the CAARS-Inv:SV Total ADHD Symptoms Score assuming a SD of 9.85 based on 2-sided significance level of 0.05 using a 2-sample t-test. Mean and SD assumptions were associated with effect size of 0.37 and 30% missing data rate. These assumptions applied to Weeks 12 and 24 treatment effects. Marginal power at Weeks 12 and 24 was 86%.||||0.001
72499941|NCT00190775|144530108|SUPERIORITY_OR_OTHER|||||||0.446||95.0||||P-Value for Total Stress.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.446
72499942|NCT00190775|144530108|SUPERIORITY_OR_OTHER|||||||0.134||95.0||||P-Value for Life Stress.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.134
72499943|NCT00190775|144530109|SUPERIORITY_OR_OTHER|||||||0.056||95.0||||P-Value for Parent Domain Total.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.056
72499944|NCT00190775|144530109|SUPERIORITY_OR_OTHER|||||||0.459||95.0||||P-Value for Parent Domain Competence.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.459
72499945|NCT00190775|144530109|SUPERIORITY_OR_OTHER|||||||0.435||95.0||||P-Value for Parent Domain Isolation.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.435
72499946|NCT00190775|144530109|SUPERIORITY_OR_OTHER|||||||0.677||95.0||||P-Value for Parent Domain Attachment.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.677
72499947|NCT00190775|144530109|SUPERIORITY_OR_OTHER|||||||0.376||95.0||||P-Value for Parent Domain Health.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.376
72499948|NCT00190775|144530109|SUPERIORITY_OR_OTHER|||||||0.176||95.0||||P-Value for Parent Domain Role Restriction.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.176
72499949|NCT00190775|144530109|SUPERIORITY_OR_OTHER|||||||0.03||95.0||||P-Value for Parent Domain Depression.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.030
72499950|NCT00190775|144530109|SUPERIORITY_OR_OTHER|||||||0.434||95.0||||P-Value for Parent Domain Spouse.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.434
72499951|NCT00190775|144530110|SUPERIORITY_OR_OTHER|||||||0.578||95.0||||P-Value for Child Domain Total.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.578
72499952|NCT00190775|144530110|SUPERIORITY_OR_OTHER|||||||0.062||95.0||||P-Value for Defensive Responding.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.062
72499953|NCT00190775|144530110|SUPERIORITY_OR_OTHER|||||||0.567||95.0||||P-Value for Child Domain Distractibility/Hyperactive.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.567
72499954|NCT00190775|144530110|SUPERIORITY_OR_OTHER|||||||0.383||95.0||||P-Value for Child Domain Adaptability.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.383
72499955|NCT00190775|144530110|SUPERIORITY_OR_OTHER|||||||0.963||95.0||||P-Value for Child Domain Reinforces Parent.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.963
72499956|NCT00190775|144530110|SUPERIORITY_OR_OTHER|||||||0.075||95.0||||P-Value for Child Domain Demandingness.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.075
72499957|NCT00190775|144530110|SUPERIORITY_OR_OTHER|||||||0.854||95.0||||P-Value for Child Domain Mood.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.854
72499958|NCT00190775|144530110|SUPERIORITY_OR_OTHER|||||||0.671||95.0||||P-Value for Child Domain Acceptability.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.671
72499959|NCT00190775|144530111|SUPERIORITY_OR_OTHER|||||||0.28||95.0||||P-Value for Total Stress.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.280
72499960|NCT00190775|144530111|SUPERIORITY_OR_OTHER|||||||0.34||95.0||||P-Value for Life Stress.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.34
72499961|NCT00190775|144530112|SUPERIORITY_OR_OTHER|||||||0.103||95.0||||P-Value for Parent Domain Total.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.103
72499962|NCT00190775|144530112|SUPERIORITY_OR_OTHER|||||||0.182||95.0||||P-Value for Parent Domain Competence.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.182
72499963|NCT00190775|144530112|SUPERIORITY_OR_OTHER|||||||0.161||95.0||||P-Value for Parent Domain Isolation.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.161
72499964|NCT00190775|144530112|SUPERIORITY_OR_OTHER|||||||0.472||95.0||||P-Value for Parent Domain Attachment.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.472
72499965|NCT00190775|144530112|SUPERIORITY_OR_OTHER|||||||0.949||95.0||||P-Value for Parent Domain Health.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.949
72499966|NCT00190775|144530112|SUPERIORITY_OR_OTHER|||||||0.848||95.0||||P-Value for Parent Domain Role Restriction.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.848
72499967|NCT00190775|144530112|SUPERIORITY_OR_OTHER|||||||0.05||95.0||||P-Value for Parent Domain Depression.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.050
72562794|NCT01976728|144657350|SUPERIORITY||LSM difference|0.93||||0.0221|TWO_SIDED|95.0|0.14|1.72||The p-value was derived from an ANCOVA model with randomization scheme and treatment as factors and baseline value as covariate.|ANCOVA||LSM difference and CIs were derived from an ANCOVA model with randomization scheme and treatment as factors and baseline value as covariate.|The mean change in LH levels from Day 10 pre-treatment (prior to first dose) in the LutrePulse 15 μg/Pulse group was compared to placebo using an ANCOVA model with randomization scheme and treatment as factors and baseline value as covariate.||1.72|0.14|0.0221
72620624|NCT02037984|144772321|OTHER|PT14 Percentage Point Difference (V114 - Prevnar 13®)|PT14 Percentage Point Difference|0.0|||||TWO_SIDED|95.0|-14.0|9.6|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||9.6|-14.0|
72455323|NCT00145470|144434058|SUPERIORITY|||||||0.3928|||||||Chi-squared|Based on Pearson's chi-squared test.||Day 3||||0.3928
72455324|NCT00145470|144434058|SUPERIORITY|||||||0.7923|||||||Chi-squared|Based on Pearson's chi-squared test.||Day 7||||0.7923
72455325|NCT00145470|144434058|SUPERIORITY|||||||0.0701|||||||Chi-squared|Based on Pearson's chi-squared test.||Day 14||||0.0701
72455326|NCT00145470|144434058|SUPERIORITY|||||||0.1634|||||||Chi-squared|Based on Pearson's chi-squared test.||Day 21||||0.1634
72455327|NCT00145470|144434058|SUPERIORITY|||||||0.037|||||||Chi-squared|Based on Pearson's chi-squared test.||Day 42||||0.0370
72455328|NCT00145470|144434058|SUPERIORITY|||||||0.0488|||||||Chi-squared|Based on Pearson's chi-squared test.||Day 63||||0.0488
72455329|NCT00145470|144434058|SUPERIORITY|||||||0.0152|||||||Chi-squared|Based on Pearson's chi-squared test.||Day 84||||0.0152
72455330|NCT00145470|144434059|SUPERIORITY|||||||0.3709|||||||Chi-squared|Based on Pearson's chi-squared test.||Day 3||||0.3709
72455331|NCT00145470|144434059|SUPERIORITY|||||||0.8837|||||||Chi-squared|Based on Pearson's chi-squared test.||Day 7||||0.8837
72455332|NCT00145470|144434059|SUPERIORITY|||||||0.1153|||||||Chi-squared|Based on Pearson's chi-squared test.||Day 14||||0.1153
72455333|NCT00145470|144434059|SUPERIORITY|||||||0.0158|||||||Chi-squared|Based on Pearson's chi-squared test.||Day 21||||0.0158
72455334|NCT00145470|144434059|SUPERIORITY|||||||0.0143|||||||Chi-squared|Based on Pearson's chi-squared test.||Day 42||||0.0143
72455335|NCT00145470|144434059|SUPERIORITY|||||||0.0196|||||||Chi-squared|Based on Pearson's chi-squared test.||Day 63||||0.0196
72455336|NCT00145470|144434059|SUPERIORITY|||||||0.0148|||||||Chi-squared|Based on Pearson's chi-squared test.||Day 84||||0.0148
72455337|NCT00145470|144434060|SUPERIORITY|||||||0.0046||||||P-value based on the difference in the LS means for asenapine versus placebo.|ANCOVA|Based on an ANCOVA model with treatment and pooled investigative site as fixed effects and baseline as a covariate.||Change from Baseline at Day 21||||0.0046
72455338|NCT00145470|144434061|SUPERIORITY|||||||0.0006||||||P-value based on the difference in the LS means for asenapine versus placebo.|ANCOVA|Based on an ANCOVA model with treatment and pooled investigative site as fixed effects and baseline as a covariate.||Change from Baseline at Day 84||||0.0006
72455339|NCT00145470|144434062|SUPERIORITY|||||||0.3497||||||P-value based on the difference in the LS means for asenapine versus placebo.|ANCOVA|Based on an ANCOVA model with treatment and pooled investigative site as fixed effects and baseline as a covariate.||Change from Baseline at Day 21||||0.3497
72455340|NCT00145470|144434063|SUPERIORITY|||||||0.7753||||||P-value based on the difference in the LS means for asenapine versus placebo.|ANCOVA|Based on an ANCOVA model with treatment and pooled investigative site as fixed effects and baseline as a covariate.||Change from Baseline at Day 84||||0.7753
72455341|NCT00145470|144434064|SUPERIORITY|||||||0.0073||||||P-value based on the difference in the LS means for asenapine versus placebo.|ANCOVA|Based on an ANCOVA model with treatment and pooled investigative site as fixed effects and baseline as a covariate.||Change from Baseline at Day 21||||0.0073
72455342|NCT00145470|144434065|SUPERIORITY|||||||0.0102||||||P-value based on the difference in the LS means for asenapine versus placebo.|ANCOVA|Based on an ANCOVA model with treatment and pooled investigative site as fixed effects and baseline as a covariate.||Change from Baseline at Day 84||||0.0102
72455343|NCT00145470|144434066|SUPERIORITY|||||||0.3684||||||P-value based on the difference in the LS means for asenapine versus placebo.|ANCOVA|Based on an ANCOVA model with treatment and pooled investigative site as fixed effects and baseline as a covariate.||Change from Baseline at Day 21||||0.3684
72455344|NCT00145470|144434067|SUPERIORITY|||||||0.937||||||P-value based on the difference in the LS means for asenapine versus placebo.|ANCOVA|Based on an ANCOVA model with treatment and pooled investigative site as fixed effects and baseline as a covariate.||Change from Baseline at Day 84||||0.9370
72455345|NCT00145470|144434068|SUPERIORITY|||||||0.2492||||||P-value based on the difference in the LS means for asenapine versus placebo.|ANCOVA|Based on an ANCOVA model with treatment and pooled investigative site as fixed effects and baseline as a covariate.||Change from Baseline at Day 21||||0.2492
72455346|NCT00145470|144434069|SUPERIORITY|||||||0.4683||||||P-value based on the difference in the LS means for asenapine versus placebo.|ANCOVA|Based on an ANCOVA model with treatment and pooled investigative site as fixed effects and baseline as a covariate.||Change from Baseline at Day 84||||0.4683
72455347|NCT00145470|144434070|SUPERIORITY|||||||0.5683||||||P-value based on the difference in the LS means for asenapine versus placebo.|ANCOVA|Based on an ANCOVA model with treatment and pooled investigative site as fixed effects and baseline as a covariate.||Change from Baseline at Day 21||||0.5683
72455348|NCT00145470|144434071|SUPERIORITY|||||||0.9693||||||P-value based on the difference in the LS means for asenapine versus placebo.|ANCOVA|Based on an ANCOVA model with treatment and pooled investigative site as fixed effects and baseline as a covariate.||Change from Baseline at Day 84||||0.9693
72455349|NCT00145470|144434072|SUPERIORITY|||||||0.6136||||||P-value based on the difference in the LS means for asenapine versus placebo.|ANCOVA|Based on an ANCOVA model with treatment and pooled investigative site as fixed effects and baseline as a covariate.||Change from Baseline at Day 21||||0.6136
72455350|NCT00145470|144434073|SUPERIORITY|||||||0.1586||||||P-value based on the difference in the LS means for asenapine versus placebo.|ANCOVA|Based on an ANCOVA model with treatment and pooled investigative site as fixed effects and baseline as a covariate.||Change from Baseline at Day 84||||0.1586
72455351|NCT00145470|144434074|SUPERIORITY|||||||0.055||||||P-value based on the difference in the LS means for asenapine versus placebo.|ANCOVA|Based on an ANCOVA model with treatment and pooled investigative site as fixed effects and baseline as a covariate.||Verbal Memory - CFB at Day 21||||0.0550
72391880|NCT00256750|144290860|NON_INFERIORITY_OR_EQUIVALENCE|A non-inferiority margin of 10% for the co-primary endpoint of participant and graft survival was used. Determination of a margin for non-inferiority based on 'preservation of benefit' is not feasible, given the low rate of patient death and/or graft loss in the first year post-transplantation, and the absence of published, adequately sized, parallel-group trials with which to assess the effect of CsA on patient death and/or graft loss in the setting of MMF/steroids/basiliximab.|Difference in Percent|3.5|||||TWO_SIDED|97.3|-2.8|10.0||||||||10.0|-2.8|
72391881|NCT00256750|144290861|SUPERIORITY_OR_OTHER||Difference in Percent|5.9|||||TWO_SIDED|95.0|-1.0|12.8||||||Month 12||12.8|-1.0|
72391882|NCT00256750|144290861|SUPERIORITY_OR_OTHER||Difference in Percent|11.5|||||TWO_SIDED|95.0|4.2|18.9||||||Month 12||18.9|4.2|
72391883|NCT00256750|144290861|SUPERIORITY_OR_OTHER||Difference in Percent|1.8|||||TWO_SIDED|95.0|-5.5|9.1||||||Month 24||9.1|-5.5|
72391884|NCT00256750|144290861|SUPERIORITY_OR_OTHER||Difference in Percent|9.8|||||TWO_SIDED|95.0|1.9|17.6||||||Month 24||17.6|1.9|
72391885|NCT00256750|144290861|SUPERIORITY_OR_OTHER||Difference in Percent|0.9|||||TWO_SIDED|95.0|-6.6|8.4||||||Month 36||8.4|-6.6|
72391886|NCT00256750|144290861|SUPERIORITY_OR_OTHER||Difference in Percent|8.4|||||TWO_SIDED|95.0|0.4|16.4||||||Month 36||16.4|0.4|
72455352|NCT00145470|144434074|SUPERIORITY|||||||0.7469||||||P-value based on the difference in the LS means for asenapine versus placebo.|ANCOVA|Based on an ANCOVA model with treatment and pooled investigative site as fixed effects and baseline as a covariate.||Visual Memory - CFB at Day 21||||0.7469
72455353|NCT00145470|144434074|SUPERIORITY|||||||0.3253||||||P-value based on the difference in the LS means for asenapine versus placebo.|ANCOVA|Based on an ANCOVA model with treatment and pooled investigative site as fixed effects and baseline as a covariate.||Processing Speed - CFB at Day 21||||0.3253
72455354|NCT00145470|144434074|SUPERIORITY|||||||0.3885||||||P-value based on the difference in the LS means for asenapine versus placebo.|ANCOVA|Based on an ANCOVA model with treatment and pooled investigative site as fixed effects and baseline as a covariate.||Social Acuity - CFB at Day 21||||0.3885
72455355|NCT00145470|144434074|SUPERIORITY|||||||0.5975||||||P-value based on the difference in the LS means for asenapine versus placebo.|ANCOVA|Based on an ANCOVA model with treatment and pooled investigative site as fixed effects and baseline as a covariate.||Reasoning - CFB at Day 21||||0.5975
72455356|NCT00145470|144434074|SUPERIORITY|||||||0.069||||||P-value based on the difference in the LS means for asenapine versus placebo.|ANCOVA|Based on an ANCOVA model with treatment and pooled investigative site as fixed effects and baseline as a covariate.||Executive Functioning - CFB at Day 21||||0.0690
72455357|NCT00145470|144434074|SUPERIORITY|||||||0.797||||||P-value based on the difference in the LS means for asenapine versus placebo.|ANCOVA|Based on an ANCOVA model with treatment and pooled investigative site as fixed effects and baseline as a covariate.||Working Memory - CFB at Day 21||||0.7970
72455358|NCT00145470|144434074|SUPERIORITY|||||||0.8339||||||P-value based on the difference in the LS means for asenapine versus placebo.|ANCOVA|Based on an ANCOVA model with treatment and pooled investigative site as fixed effects and baseline as a covariate.||Sustained Attention - CFB at Day 21||||0.8339
72391887|NCT01197560|144290864|SUPERIORITY|||||||0.079|||||||Fisher Exact|||Pertains to all participants; row 1||||0.079
72391888|NCT01197560|144290864|SUPERIORITY|||||||0.279|||||||Fisher Exact|||Pertains to GCB Subtype; row 2||||0.279
72391889|NCT01197560|144290864|SUPERIORITY|||||||0.179|||||||Fisher Exact|||Pertains to non-GCB Sub-type; row 3||||0.179
72391890|NCT01197560|144290865|SUPERIORITY|||||||0.091|||||||Fisher Exact|||Pertains to all participants||||0.091
72391891|NCT01197560|144290866|SUPERIORITY|||||||0.109|||||||Fisher Exact|||||||0.109
72391892|NCT01197560|144290867|SUPERIORITY|||||||0.16|||||||Fisher Exact|||Pertains to all participants; row 1||||0.160
72391893|NCT01197560|144290868|SUPERIORITY|||||||0.529|||||||Log Rank|||||||0.529
72391894|NCT01197560|144290869|SUPERIORITY|||||||0.972|||||||Log Rank|||||||0.972
72391895|NCT01197560|144290870|SUPERIORITY|||||||0.02|||||||Log Rank|||||||0.020
72391896|NCT01197560|144290871|SUPERIORITY|||||||0.211|||||||Log Rank|||||||0.211
72391897|NCT01600638|144290883|OTHER||Mean Difference (Net)|-1.3|STANDARD_ERROR_OF_MEAN|0.27|||TWO_SIDED|||||||||||||
72391898|NCT01600638|144290884|OTHER||sucess proportion|0.7823|||||TWO_SIDED|95.0|0.614|0.951||||||||0.951|0.614|
72391899|NCT02342327|144290896|OTHER||Hazard Ratio (HR)|0.82|||||TWO_SIDED|95.0|0.55|1.22||||||Hazard ratio for time to lapse to smoking in the group switched to non-menthol cigarettes relative to the group continuing to smoke menthol cigarettes||1.22|0.55|
72391900|NCT02342327|144290897|OTHER||Hazard Ratio (HR)|0.67|||||TWO_SIDED|95.0|0.42|1.06||||||Hazard ratio for time to relapse to smoking in the group switched to non-menthol cigarettes relative to the group continuing to smoke menthol cigarettes||1.06|0.42|
72391901|NCT04666051|144290918|SUPERIORITY|Data from both groups has been collected compared to verify significant statistical difference||||||0.022|||||||Chi-squared|||||||0.022
72395198|NCT05355805|144297051|SUPERIORITY||Risk Difference (RD)|4.19|STANDARD_ERROR_OF_MEAN|8.427||0.6192|TWO_SIDED|||||The estimated risk difference divided by the standard error was used as the test statistic and a p-value calculated assuming that the test statistic follows a standard normal distribution under the null hypothesis.|Cochran-Mantel-Haenszel|||"The common risk difference between placebo QW/Q2W and the izokibep 160 mg Q2W arm among the four strata, prior biologic/JAK inhibitor use for HS (Yes/No) and Hurley Stage (II or III), used for randomization and associated standard error was estimated by combining the observed risk differences using Cochran-Mantel-Haenszel weighting.~Non-response imputation was used for participants with missing HiSCR75."||||0.6192
72455359|NCT00145470|144434074|SUPERIORITY|||||||0.2101||||||P-value based on the difference in the LS means for asenapine versus placebo.|ANCOVA|Based on an ANCOVA model with treatment and pooled investigative site as fixed effects and baseline as a covariate.||Composite Memory - CFB at Day 21||||0.2101
72455360|NCT00145470|144434075|SUPERIORITY|||||||0.6914||||||P-value based on the difference in the LS means for asenapine versus placebo.|ANCOVA|Based on an ANCOVA model with treatment and pooled investigative site as fixed effects and baseline as a covariate.||Verbal Memory - CFB at Day 84||||0.6914
72455361|NCT00145470|144434075|SUPERIORITY|||||||0.8805||||||P-value based on the difference in the LS means for asenapine versus placebo.|ANCOVA|Based on an ANCOVA model with treatment and pooled investigative site as fixed effects and baseline as a covariate.||Visual Memory - CFB at Day 84||||0.8805
72499968|NCT00190775|144530112|SUPERIORITY_OR_OTHER|||||||0.84||95.0||||P-Value for Parent Domain Spouse.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.840
72455362|NCT00145470|144434075|SUPERIORITY|||||||0.4878||||||P-value based on the difference in the LS means for asenapine versus placebo.|ANCOVA|Based on an ANCOVA model with treatment and pooled investigative site as fixed effects and baseline as a covariate.||Processing Speed - CFB at Day 84||||0.4878
72455363|NCT00145470|144434075|SUPERIORITY|||||||0.8051||||||P-value based on the difference in the LS means for asenapine versus placebo.|ANCOVA|Based on an ANCOVA model with treatment and pooled investigative site as fixed effects and baseline as a covariate.||Social Acuity - CFB at Day 84||||0.8051
72455364|NCT00145470|144434075|SUPERIORITY|||||||0.1925||||||P-value based on the difference in the LS means for asenapine versus placebo.|ANCOVA|Based on an ANCOVA model with treatment and pooled investigative site as fixed effects and baseline as a covariate.||Reasoning - CFB at Day 84||||0.1925
72455365|NCT00145470|144434075|SUPERIORITY|||||||0.0514||||||P-value based on the difference in the LS means for asenapine versus placebo.|ANCOVA|Based on an ANCOVA model with treatment and pooled investigative site as fixed effects and baseline as a covariate.||Executive Functioning - CFB at Day 84||||0.0514
72455366|NCT00145470|144434075|SUPERIORITY|||||||0.9898||||||P-value based on the difference in the LS means for asenapine versus placebo.|ANCOVA|Based on an ANCOVA model with treatment and pooled investigative site as fixed effects and baseline as a covariate.||Working Memory - CFB at Day 84||||0.9898
72455367|NCT00145470|144434075|SUPERIORITY|||||||0.5683||||||P-value based on the difference in the LS means for asenapine versus placebo.|ANCOVA|Based on an ANCOVA model with treatment and pooled investigative site as fixed effects and baseline as a covariate.||Sustained Attention - CFB at Day 84||||0.5683
72455368|NCT00145470|144434075|SUPERIORITY|||||||0.8907||||||P-value based on the difference in the LS means for asenapine versus placebo.|ANCOVA|Based on an ANCOVA model with treatment and pooled investigative site as fixed effects and baseline as a covariate.||Composite Memory - CFB at Day 84||||0.8907
72455369|NCT00145470|144434076|SUPERIORITY|||||||0.0613|||||||Log Rank|||||||0.0613
72455370|NCT00145470|144434077|SUPERIORITY|||||||0.7493||||||P-value based on the difference in the LS means for asenapine versus placebo.|ANCOVA|Based on an ANCOVA model with treatment and pooled investigative site as fixed effects and baseline as a covariate.||Change from Baseline at Day 21||||0.7493
72455371|NCT00145470|144434078|SUPERIORITY|||||||0.4884||||||P-value based on the difference in the LS means for asenapine versus placebo.|ANCOVA|Based on an ANCOVA model with treatment and pooled investigative site as fixed effects and baseline as a covariate.||Change from Baseline at Day 84||||0.4884
72455372|NCT00145470|144434079|SUPERIORITY|||||||0.128||||||P-value based on the difference in the LS means for asenapine versus placebo.|ANCOVA|Based on an ANCOVA model with treatment and pooled investigative site as fixed effects and baseline as a covariate.||PCS - Change from Baseline at Day 21||||0.1280
72455373|NCT00145470|144434079|SUPERIORITY|||||||0.0215||||||P-value based on the difference in the LS means for asenapine versus placebo.|ANCOVA|Based on an ANCOVA model with treatment and pooled investigative site as fixed effects and baseline as a covariate.||MCS - Change from Baseline at Day 21||||0.0215
72455374|NCT00145470|144434080|SUPERIORITY|||||||0.1331||||||P-value based on the difference in the LS means for asenapine versus placebo.|ANCOVA|Based on an ANCOVA model with treatment and pooled investigative site as fixed effects and baseline as a covariate.||PCS - Change from Baseline at Day 84||||0.1331
72455375|NCT00145470|144434080|SUPERIORITY|||||||0.2024||||||P-value based on the difference in the LS means for asenapine versus placebo.|ANCOVA|Based on an ANCOVA model with treatment and pooled investigative site as fixed effects and baseline as a covariate.||MCS - Change from Baseline at Day 84||||0.2024
72455376|NCT03365622|144434082|SUPERIORITY||Mean Difference (Final Values)|6.306|STANDARD_ERROR_OF_MEAN|7.379||0.3938|TWO_SIDED|95.0|-8.242|20.854|||Regression, Linear|Adjusted for age, sex, BMI, type of surgery and TAP block.|"The estimate reflects the adjusted difference in mean outcome between arms/groups, with the placebo IV + oral acetaminophen serving as the reference group."|A multiple linear regression model was used to examine the association between treatment assignment and the total opioid dose administered intraoperatively and postoperatively, adjusting for patient age, gender, body mass index (BMI), type of surgery (laparoscopic donor nephrectomy or laparoscopic nephrectomy for renal cancer), and whether the patient received a TAP block during surgery.||20.854|-8.242|0.3938
72499969|NCT00190775|144530113|SUPERIORITY_OR_OTHER|||||||0.785||95.0||||P-Value for Child Domain Total.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.785
72499970|NCT00190775|144530113|SUPERIORITY_OR_OTHER|||||||0.081||95.0||||P-Value for Defensive Responding.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.081
72455377|NCT03365622|144434083|SUPERIORITY||Mean Difference (Final Values)|0.107|STANDARD_ERROR_OF_MEAN|0.283||0.7051|TWO_SIDED|95.0|-0.451|0.666|||Regression, Linear|Adjusted for age, sex, BMI, type of surgery and TAP block.|"The estimate reflects the adjusted difference in mean outcome between arms/groups, with the placebo IV + oral acetaminophen serving as the reference group."|A multiple linear regression model was used to examine the association between treatment assignment and the 20-24 hours post-op average surgical pain, adjusting for patient age, gender, body mass index (BMI), type of surgery (laparoscopic donor nephrectomy or laparoscopic nephrectomy for renal cancer), and whether the patient received a TAP block during surgery.||0.666|-0.451|0.7051
72455378|NCT03365622|144434084|SUPERIORITY||Mean Difference (Final Values)|0.276|STANDARD_ERROR_OF_MEAN|0.317||0.3852|TWO_SIDED|95.0|-0.349|0.901|||Regression, Linear|Adjusted for age, sex, BMI, type of surgery and TAP block.|"The estimate reflects the adjusted difference in mean outcome between arms/groups, with the placebo IV + oral acetaminophen serving as the reference group."|A multiple linear regression model was used to examine the association between treatment assignment and the 1-2 hours post-op average surgical pain, adjusting for patient age, gender, body mass index (BMI), type of surgery (laparoscopic donor nephrectomy or laparoscopic nephrectomy for renal cancer), and whether the patient received a TAP block during surgery.||0.901|-0.349|0.3852
72499971|NCT00190775|144530113|SUPERIORITY_OR_OTHER|||||||0.518||95.0||||P-Value for Child Domain Distractibility/Hyperactive.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.518
72499972|NCT00190775|144530113|SUPERIORITY_OR_OTHER|||||||0.883||95.0||||P-Value for Child Domain Adaptability.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.883
72499973|NCT00190775|144530113|SUPERIORITY_OR_OTHER|||||||0.439||95.0||||P-Value for Child Domain Reinforces Parent.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.439
72620625|NCT02037984|144772321|OTHER|PT18C Percentage Point Difference (V114 - Prevnar 13®)|PT18C Percentage Point Difference|0.0|||||TWO_SIDED|95.0|-14.5|9.6|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||9.6|-14.5|
72620626|NCT02037984|144772321|OTHER|PT19A Percentage Point Difference (V114 - Prevnar 13®)|PT19A Percentage Point Difference|0.0|||||TWO_SIDED|95.0|-14.0|9.6|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||9.6|-14.0|
72620627|NCT02037984|144772321|OTHER|PT19F Percentage Point Difference (V114 - Prevnar 13®)|PT19F Percentage Point Difference|0.0|||||TWO_SIDED|95.0|-14.0|9.6|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||9.6|-14.0|
72620628|NCT02037984|144772321|OTHER|PT23F Percentage Point Difference (V114 - Prevnar 13®)|PT23F Percentage Point Difference|0.0|||||TWO_SIDED|95.0|-14.0|9.6|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||9.6|-14.0|
72620629|NCT02037984|144772321|OTHER|non-PT22F Percentage Point Difference (V114 - Prevnar 13®)|non-PT22F Percentage Point Difference|85.0|||||TWO_SIDED|95.0|65.8|93.6|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||93.6|65.8|
72620630|NCT02037984|144772321|OTHER|non-PT33F Percentage Point Difference (V114 - Prevnar 13®)|non-PT33F Percentage Point Difference|92.9|||||TWO_SIDED|95.0|75.1|98.1|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||98.1|75.1|
72620631|NCT02037984|144772322|OTHER|PT1 Percentage Point Difference (V114 - Prevnar 13®)|PT1 Percentage Point Difference|-3.0|||||TWO_SIDED|95.0|-15.5|6.7|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||6.7|-15.5|
72620632|NCT02037984|144772322|OTHER|PT3 Percentage Point Difference (V114 - Prevnar 13®)|PT3 Percentage Point Difference|24.3|||||TWO_SIDED|95.0|12.6|40.2|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||40.2|12.6|
72391902|NCT01651195|144290919|SUPERIORITY|We estimated that, with a power of 85% and at a significance level of 0.05 (Power 0.85, ß=0.14990 and α=0.05), we needed 467 conscripts per group to show a 17% difference between the groups. Each conscript was randomly allocated to the probiotic or the control group according to a computer generated, 8-blocked randomization list.|||||<|0.05|||||||Fisher Exact||||"Result variables were analyzed according to intention to treat (ITT) principle. Missing data was handled by statistic modeling. Data on symptom diaries were calculated as follows: the incidence and duration of individual infection symptoms and respiratory episodes were analyzed between the intervention groups using time to event analysis (cox model for hazard) and duration analysis (gamma regression model). The results are expressed as a hazard ratio (incidence rate ratio) of symptoms and the mean duration of symptoms (days) with 95% confidence intervals or standard deviations. The sums of respiratory and gastrointestinal symptoms were calculated with gamma regression analysis."|||< 0.05
72391903|NCT01651195|144290920|SUPERIORITY||||||<|0.05|||||||Fisher Exact|||||||< 0.05
72391904|NCT01651195|144290921|SUPERIORITY||||||<|0.05|||||||Fisher Exact|||||||< 0.05
72499974|NCT00190775|144530113|SUPERIORITY_OR_OTHER|||||||0.167||95.0||||P-Value for Child Domain Demandingness.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.167
72391905|NCT01651195|144290922|SUPERIORITY||||||<|0.05|||||||Fisher Exact|||||||< 0.05
72391906|NCT02820753|144290978|SUPERIORITY||Mean Difference (Net)|0.26||||0.04|TWO_SIDED|95.0|0.01|0.51||The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis||Treatment difference = (Text or Portal) - Enhanced Usual Care|||0.51|0.01|0.04
72391907|NCT02820753|144290979|SUPERIORITY||Mean Difference (Net)|0.04||||0.53|TWO_SIDED|95.0|-0.08|0.15||The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis||Treatment Difference = (Text or Portal - Enhanced Usual Care|||0.15|-0.08|0.53
72391908|NCT02820753|144290980|SUPERIORITY||Mean Difference (Net)|-0.34||||0.41|TWO_SIDED|95.0|-1.16|0.48||The threshold for significance is p \< 0.05|Mixed Models Analysis||Treatment Difference = (Text or Portal) - Enhanced Usual Care|||0.48|-1.16|0.41
72391909|NCT02820753|144290981|SUPERIORITY||Mean Difference (Net)|1.83||||0.27|TWO_SIDED|95.0|-1.39|5.06||The threshold for significance is p \< 0.05|Mixed Models Analysis||Treatment difference = (Text or Portal ) - Enhanced Usual Care|||5.06|-1.39|0.27
72620633|NCT02037984|144772322|OTHER|PT4 Percentage Point Difference (V114 - Prevnar 13®)|PT4 Percentage Point Difference|2.7|||||TWO_SIDED|95.0|-8.0|14.0|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||14.0|-8.0|
72620634|NCT02037984|144772322|OTHER|PT5 Percentage Point Difference (V114 - Prevnar 13®)|PT5 Percentage Point Difference|0.0|||||TWO_SIDED|95.0|-10.6|9.5|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||9.5|-10.6|
72391910|NCT02820753|144290982|SUPERIORITY||Mean Difference (Net)|-0.23||||0.33|TWO_SIDED|95.0|-0.68|0.23||The threshold for significance is p \< 0.05|Mixed Models Analysis||Treatment Difference = (Text or Portal) - Enhanced Usual Care|||0.23|-0.68|0.33
72499975|NCT00190775|144530113|SUPERIORITY_OR_OTHER|||||||0.381||95.0||||P-Value for Child Domain Mood.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.381
72499976|NCT00190775|144530113|SUPERIORITY_OR_OTHER|||||||0.906||95.0||||P-Value for Child Domain Acceptability.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.906
72620635|NCT02037984|144772322|OTHER|PT6A Percentage Point Difference (V114 - Prevnar 13®)|PT6A Percentage Point Difference|0.0|||||TWO_SIDED|95.0|-10.6|9.5|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||9.5|-10.6|
72620636|NCT02037984|144772322|OTHER|PT6B Percentage Point Difference (V114 - Prevnar 13®)|PT6B Percentage Point Difference|-3.0|||||TWO_SIDED|95.0|-15.5|6.7|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||6.7|-15.5|
72620637|NCT02037984|144772322|OTHER|PT7F Percentage Point Difference (V114 - Prevnar 13®)|PT7F Percentage Point Difference|0.0|||||TWO_SIDED|95.0|-10.6|9.5|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||9.5|-10.6|
72620638|NCT02037984|144772322|OTHER|PT9V Percentage Point Difference (V114 - Prevnar 13®)|PT9V Percentage Point Difference|0.0|||||TWO_SIDED|95.0|-10.6|9.5|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||9.5|-10.6|
72620639|NCT02037984|144772322|OTHER|PT14 Percentage Point Difference (V114 - Prevnar 13®)|PT14 Percentage Point Difference|0.0|||||TWO_SIDED|95.0|-10.6|9.5|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||9.5|-10.6|
72620640|NCT02037984|144772322|OTHER|PT18C Percentage Point Difference (V114 - Prevnar 13®)|PT18C Percentage Point Difference|0.0|||||TWO_SIDED|95.0|-10.6|9.5|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||9.5|-10.6|
72455379|NCT03365622|144434085|SUPERIORITY||Mean Difference (Final Values)|0.534|STANDARD_ERROR_OF_MEAN|2.816||0.8498|TWO_SIDED|95.0|-5.02|6.088|||Regression, Linear|Adjusted for age, sex, BMI, type of surgery and TAP block.|"The estimate reflects the adjusted difference in mean outcome between arms/groups, with the placebo IV + oral acetaminophen serving as the reference group."|A multiple linear regression model was used to examine the association between treatment assignment and the 1-2 hours post-op inspiratory capacity percentage, adjusting for patient age, gender, body mass index (BMI), type of surgery (laparoscopic donor nephrectomy or laparoscopic nephrectomy for renal cancer), and whether the patient received a TAP block during surgery.||6.088|-5.02|0.8498
72499977|NCT00190775|144530114|SUPERIORITY_OR_OTHER|||||||0.42||95.0||||P-Value for Parent Involvement.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.420
72499978|NCT00190775|144530114|SUPERIORITY_OR_OTHER|||||||0.249||95.0||||P-Value for Parent Positive Parenting.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.249
72499979|NCT00190775|144530114|SUPERIORITY_OR_OTHER|||||||0.927||95.0||||P-Value for Parent Poor Supervision.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.927
72499980|NCT00190775|144530114|SUPERIORITY_OR_OTHER|||||||0.205||95.0||||P-Value for Parent Inconsistent Discipline.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.205
72499981|NCT00190775|144530114|SUPERIORITY_OR_OTHER|||||||0.673||95.0||||P-Value for Parent Corporal Punishment.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.673
72499982|NCT00190775|144530114|SUPERIORITY_OR_OTHER|||||||0.881||95.0||||P-Value for Parent Other Discipline Practice.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.881
72499983|NCT00190775|144530114|SUPERIORITY_OR_OTHER|||||||0.808||95.0||||P-Value for Dysfunctional Parenting Composite.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.808
72499984|NCT00190775|144530114|SUPERIORITY_OR_OTHER|||||||0.498||95.0||||P-Value for Negative Parenting Composite.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.498
72499985|NCT00190775|144530114|SUPERIORITY_OR_OTHER|||||||0.283||95.0||||P-Value for Positive Parenting Composite.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.283
72499986|NCT00190775|144530115|SUPERIORITY_OR_OTHER|||||||0.784||95.0||||P-Value for Parent Involvement.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.784
72499987|NCT00190775|144530115|SUPERIORITY_OR_OTHER|||||||0.864||95.0||||P-Value for Parent Positive Parenting.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.864
72499988|NCT00190775|144530115|SUPERIORITY_OR_OTHER|||||||0.884||95.0||||P-Value for Parent Poor Supervision.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.884
72499989|NCT00190775|144530115|SUPERIORITY_OR_OTHER|||||||0.072||95.0||||P-Value for Parent Inconsistent Discipline.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.072
72499990|NCT00190775|144530115|SUPERIORITY_OR_OTHER|||||||0.12||95.0||||P-Value for Parent Corporal Punishment.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.120
72499991|NCT00190775|144530115|SUPERIORITY_OR_OTHER|||||||0.925||95.0||||P-Value Other Discipline Practice.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.925
72499992|NCT00190775|144530115|SUPERIORITY_OR_OTHER|||||||0.444||95.0||||P-Value for Dysfunctional Parenting Composite.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.444
72499993|NCT00190775|144530115|SUPERIORITY_OR_OTHER|||||||0.166||95.0||||P-Value for Negative Parenting Composite.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.166
72499994|NCT00190775|144530115|SUPERIORITY_OR_OTHER|||||||0.875||95.0||||P-Value for Positive Parenting Composite.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.875
72499995|NCT00190775|144530116|SUPERIORITY_OR_OTHER|||||||0.895||95.0||||P-Value for Child Involvement Mother.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.895
72499996|NCT00190775|144530116|SUPERIORITY_OR_OTHER|||||||0.792||95.0||||P-Value for Child Involvement Father.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.792
72499997|NCT00190775|144530116|SUPERIORITY_OR_OTHER|||||||0.318||95.0||||P-Value for Child Positive Parenting.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.318
72499998|NCT00190775|144530116|SUPERIORITY_OR_OTHER|||||||0.914||95.0||||P-Value for Child Poor Supervision.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.914
72499999|NCT00190775|144530116|SUPERIORITY_OR_OTHER|||||||0.961||95.0||||P-Value for Child Inconsistent Discipline.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.961
72500000|NCT00190775|144530116|SUPERIORITY_OR_OTHER|||||||0.807||95.0||||P-Value for Child Corporal Punishment.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.807
72500001|NCT00190775|144530116|SUPERIORITY_OR_OTHER|||||||0.827||95.0||||P-Value for Child Other Discipline Practice.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.827
72500002|NCT00190775|144530117|SUPERIORITY_OR_OTHER|||||||0.828||95.0||||P-Value for Child Involvement Mother.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.828
72500003|NCT00190775|144530117|SUPERIORITY_OR_OTHER|||||||0.401||95.0||||P-Value for Child Involvement Father.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.401
72500004|NCT00190775|144530117|SUPERIORITY_OR_OTHER|||||||0.3||95.0||||P-Value for Child Positive Parenting.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.300
72500005|NCT00190775|144530117|SUPERIORITY_OR_OTHER|||||||0.575||95.0||||P-Value for Child Poor Supervision.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.575
72500006|NCT00190775|144530117|SUPERIORITY_OR_OTHER|||||||0.772||95.0||||P-Value for Child Inconsistent Discipline.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.772
72500007|NCT00190775|144530117|SUPERIORITY_OR_OTHER|||||||0.918||95.0||||P-Value for Child Corporal Punishment.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.918
72391911|NCT01751867|144291031|SUPERIORITY_OR_OTHER||ORR %|29.4||||0.003|TWO_SIDED|95.0|15.1|47.5|||Exact binomial proportion test||ORR % = Number of participants who achieved response divided by total ITT participants|Null Hypothesis: threshold for statistical significance = 10%||47.5|15.1|0.003
72562795|NCT01976728|144657350|SUPERIORITY||LSM difference|0.76||||0.0316|TWO_SIDED|95.0|0.07|1.44||The p-value was derived from an ANCOVA model with randomization scheme and treatment as factors and baseline value as covariate.|ANCOVA||LSM difference and CIs were derived from an ANCOVA model with randomization scheme and treatment as factors and baseline value as covariate.|The mean change in LH levels from Day 10 pre-treatment (prior to first dose) in the LutrePulse 20 μg/Pulse group was compared to placebo using an ANCOVA model with randomization scheme and treatment as factors and baseline value as covariate.||1.44|0.07|0.0316
72562796|NCT01976728|144657352|SUPERIORITY||LSM difference|73.0||||0.3147|TWO_SIDED|95.0|-72.66|218.65||The p-value was derived from an ANCOVA model with randomization scheme and treatment as factors and baseline value as covariate.|ANCOVA||LSM difference and CIs were derived from an ANCOVA model with randomization scheme and treatment as factors and baseline value as covariate.|The mean change in E2 levels from Day 10 pre-treatment (prior to first dose) in the LutrePulse 10 μg/Pulse group was compared to placebo using an ANCOVA model with randomization scheme and treatment as factors and baseline value as covariate.||218.65|-72.66|0.3147
72562797|NCT01976728|144657352|SUPERIORITY||LSM difference|95.18||||0.229|TWO_SIDED|95.0|-63.01|253.36||The p-value was derived from an ANCOVA model with randomization scheme and treatment as factors and baseline value as covariate.|ANCOVA||LSM difference and CIs were derived from an ANCOVA model with randomization scheme and treatment as factors and baseline value as covariate.|The mean change in E2 levels from Day 10 pre-treatment (prior to first dose) in the LutrePulse 15 μg/Pulse group was compared to placebo using an ANCOVA model with randomization scheme and treatment as factors and baseline value as covariate.||253.36|-63.01|0.2290
72562798|NCT01976728|144657352|SUPERIORITY||LSM difference|46.99||||0.5066|TWO_SIDED|95.0|-95.64|189.61||The p-value was derived from an ANCOVA model with randomization scheme and treatment as factors and baseline value as covariate.|ANCOVA||LSM difference and CIs were derived from an ANCOVA model with randomization scheme and treatment as factors and baseline value as covariate.|The mean change in E2 levels from Day 10 pre-treatment (prior to first dose) in the LutrePulse 20 μg/Pulse group was compared to placebo using an ANCOVA model with randomization scheme and treatment as factors and baseline value as covariate.||189.61|-95.64|0.5066
72562799|NCT00966381|144657360|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<0.05
72562800|NCT00966381|144657361|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<0.05
72562801|NCT00966381|144657362|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<0.05
72562802|NCT03244475|144657384|SUPERIORITY|Statistical analysis was carried out for the difference scores to assess group differences between TES and Sham groups.|Mean Difference (Final Values)|1.6||||0.01|TWO_SIDED|95.0|1.1|2.2||The corrected p-value of 0.01 was chosen after the standard cluster analysis for correcting family-wise error across different voxels.|Wilcoxon (Mann-Whitney)|Wilcoxon test was chosen due to potential non-normal distribution for the difference scores.||The analysis was performed for the voxel-wise delta-band activity from the frontal pole and inferior frontal gyri. Spatial smoothing and logarithm transformation (e-based) were performed. Resting-state MEG activity differences between pre- and post-treatment measures were obtained as difference scores for TES and Sham separately. The null hypothesis was that there was no group difference in the pre- and post-treatment difference scores between TES and Sham groups||2.2|1.1|0.01
72562803|NCT03244475|144657385|SUPERIORITY|Statistical analysis was carried out for the difference scores to assess group differences between TES and Sham groups.||||||0.05|||||||Wilcoxon (Mann-Whitney)|Wilcoxon test was chosen due to potential non-normal distribution for the difference scores.||Differences between pre- and post-treatment measures were obtained as difference scores for TES and Sham separately. The null hypothesis was that there was no group difference in the pre- and post-treatment difference scores between TES and Sham groups||||0.05
72562804|NCT03244475|144657386|SUPERIORITY|Statistical analysis was carried out for the difference scores to assess group differences between TES and Sham groups.||||||0.05|||||||Wilcoxon (Mann-Whitney)|Wilcoxon test was chosen due to potential non-normal distribution for the difference scores.||Differences between pre- and post-treatment measures were obtained as difference scores for TES and Sham separately. The null hypothesis was that there was no group difference in the pre- and post-treatment difference scores between TES and Sham groups||||0.05
72562805|NCT03244475|144657387|SUPERIORITY|Statistical analysis was carried out for the difference scores to assess group differences between TES and Sham groups.||||||0.05|||||||Wilcoxon (Mann-Whitney)|Wilcoxon test was chosen due to potential non-normal distribution for the difference scores.||Differences between pre- and post-treatment measures were obtained as difference scores for TES and Sham separately. The null hypothesis was that there was no group difference in the pre- and post-treatment difference scores between TES and Sham groups||||0.05
72562806|NCT03244475|144657388|SUPERIORITY|Statistical analysis was carried out for the difference scores to assess group differences between TES and Sham groups.||||||0.05|||||||Wilcoxon (Mann-Whitney)|Wilcoxon test was chosen due to potential non-normal distribution for the difference scores.||Differences between pre- and post-treatment measures were obtained as difference scores for TES and Sham separately. The null hypothesis was that there was no group difference in the pre- and post-treatment difference scores between TES and Sham groups||||0.05
72620641|NCT02037984|144772322|OTHER|PT19A Percentage Point Difference (V114 - Prevnar 13®)|PT19A Percentage Point Difference|0.0|||||TWO_SIDED|95.0|-10.6|9.5|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||9.5|-10.6|
72391912|NCT01751867|144291031|SUPERIORITY_OR_OTHER||ORR %|25.5|||<|0.001|TWO_SIDED|95.0|17.2|35.3|||Exact binomial proportion test|||Null Hypothesis: threshold for statistical significance = 10%||35.3|17.2|<0.001
72391913|NCT01806545|144291038|SUPERIORITY_OR_OTHER_LEGACY||Proportion treatment difference|-0.11||||0.1197|TWO_SIDED|95.0|-0.242|0.025||P-value was based on Cochran-Mantel-Haenszel test stratified by diabetic status at surgery comparing the 2 treatment groups.|Cochran-Mantel-Haenszel|||||0.025|-0.242|0.1197
72391914|NCT01806545|144291039|SUPERIORITY_OR_OTHER_LEGACY||Proportion treatment difference|-0.08||||0.1962|TWO_SIDED|95.0|-0.204|0.045||P-value was based on Cochran-Mantel-Haenszel test stratified by diabetic status at surgery comparing the 2 treatment groups.|Cochran-Mantel-Haenszel|||||0.045|-0.204|0.1962
72620642|NCT02037984|144772322|OTHER|PT19F Percentage Point Difference (V114 - Prevnar 13®)|PT19F Percentage Point Difference|0.0|||||TWO_SIDED|95.0|-10.6|9.5|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||9.5|-10.6|
72620643|NCT02037984|144772322|OTHER|PT23F Percentage Point Difference (V114 - Prevnar 13®)|PT23F Percentage Point Difference|-3.0|||||TWO_SIDED|95.0|-15.5|6.7|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||6.7|-15.5|
72620644|NCT02037984|144772322|OTHER|non-PT22F Percentage Point Difference (V114 - Prevnar 13®)|non-PT22F Percentage Point Difference|89.2|||||TWO_SIDED|95.0|75.2|95.7|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||95.7|75.2|
72620645|NCT02037984|144772322|OTHER|non-PT33F Percentage Point Difference (V114 - Prevnar 13®)|non-PT33F Percentage Point Difference|97.3|||||TWO_SIDED|95.0|85.7|99.5|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||99.5|85.7|
72620646|NCT02037984|144772323|OTHER|PT1 Percentage Point Difference (V114 - Prevnar 13®)|PT1 Percentage Point Difference|0.0|||||TWO_SIDED|95.0|-10.3|9.5|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||9.5|-10.3|
72391915|NCT01806545|144291040|SUPERIORITY_OR_OTHER_LEGACY|||||||0.09|TWO_SIDED|||||P-value based on log-rank test stratified by diabetic status at surgery comparing the 2 treatment groups.|Log Rank|||||||0.090
72391916|NCT01806545|144291041|SUPERIORITY_OR_OTHER_LEGACY|||||||0.193|TWO_SIDED||||||Log Rank|P-value based on log-rank test stratified by diabetic status at surgery comparing the 2 treatment groups.||Analysis of time to loss of patency||||0.193
72391917|NCT01806545|144291042|SUPERIORITY_OR_OTHER_LEGACY|||||||0.231|TWO_SIDED|||||P-value based on log-rank test stratified by diabetic status at surgery comparing the 2 treatment groups.|Log Rank|||Analysis of time to loss of patency||||0.231
72391918|NCT01806545|144291043|SUPERIORITY_OR_OTHER_LEGACY|||||||0.158|TWO_SIDED|||||P-value based on log-rank test stratified by diabetic status at surgery comparing the 2 treatment groups.|Log Rank|||Analysis of time to loss of patency||||0.158
72391919|NCT01806545|144291044|SUPERIORITY_OR_OTHER_LEGACY||Mean treatment difference|-0.895|||||TWO_SIDED|95.0|-2.213|0.423||||||Treatment difference at week 12||0.423|-2.213|
72500008|NCT00190775|144530117|SUPERIORITY_OR_OTHER|||||||0.636||95.0||||P-Value for Child Other Discipline Practice.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.636
72500009|NCT00190775|144530118|SUPERIORITY_OR_OTHER|||||||0.583||95.0||||P-Value for Total ADHD Score.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.583
72500010|NCT00190775|144530118|SUPERIORITY_OR_OTHER|||||||0.997||95.0||||P-Value for Hyperactive-Impulsive Symptom ADHD Score.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.997
72500011|NCT00190775|144530118|SUPERIORITY_OR_OTHER|||||||0.333||95.0||||P-Value for Inattention Symptom ADHD Score.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.333
72500012|NCT00190775|144530119|SUPERIORITY_OR_OTHER|||||||0.792||95.0||||P-Value for Oppositional Defiant Disorder Flag|Fisher Exact|||||||.792
72500013|NCT00190775|144530119|SUPERIORITY_OR_OTHER|||||||0.675||95.0||||P-Value for Conduct Disorder Flag.|Fisher Exact|||||||0.675
72500014|NCT00190775|144530120|SUPERIORITY_OR_OTHER|||||||0.875||95.0||||P-Value for PSOC Total.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.875
72500015|NCT00190775|144530120|SUPERIORITY_OR_OTHER|||||||0.569||95.0||||P-Value for Satisfaction Scale.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.569
72391920|NCT01806545|144291044|SUPERIORITY_OR_OTHER_LEGACY||Mean treatment difference|-0.232|||||TWO_SIDED|95.0|-1.791|1.327||||||Treatment difference at week 26||1.327|-1.791|
72391921|NCT01806545|144291045|SUPERIORITY_OR_OTHER_LEGACY||Proportion treatment difference|-0.04|||||TWO_SIDED|95.0|-0.273|0.2||||||Analysis of week 12||0.200|-0.273|
72391922|NCT01806545|144291045|SUPERIORITY_OR_OTHER_LEGACY||Proportion treatment difference|0.08|||||TWO_SIDED|95.0|-0.165|0.318||||||Analysis of week 26||0.318|-0.165|
72391923|NCT01806545|144291046|SUPERIORITY_OR_OTHER_LEGACY||Mean treatment difference|0.154|||||TWO_SIDED|95.0|-0.096|0.404||||||Analysis of week 12||0.404|-0.096|
72391924|NCT01806545|144291046|SUPERIORITY_OR_OTHER_LEGACY||Mean treatment difference|0.565|||||TWO_SIDED|95.0|-0.023|1.152||||||Analysis of week 26||1.152|-0.023|
72391925|NCT00133952|144291068|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.63||||0.724|TWO_SIDED|95.0|0.15|2.67|||Fisher Exact|||||2.67|0.15|0.724
72500016|NCT00190775|144530120|SUPERIORITY_OR_OTHER|||||||0.399||95.0||||P-Value for Efficacy Scale.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.399
72500017|NCT00190775|144530121|SUPERIORITY_OR_OTHER|||||||0.365||95.0||||P-Value for PSOC Total.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.365
72500018|NCT00190775|144530121|SUPERIORITY_OR_OTHER|||||||0.62||95.0||||P-Value for Satisfaction Scale.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.620
72500019|NCT00190775|144530121|SUPERIORITY_OR_OTHER|||||||0.462||95.0||||P-Value for Efficacy Scale.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.462
72500020|NCT00190775|144530122|SUPERIORITY_OR_OTHER|||||||0.001||95.0||||P-Value for Total Score at 12 Weeks.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.001
72500021|NCT00190775|144530122|SUPERIORITY_OR_OTHER|||||||0.004||95.0||||P-Value for Hyperactivity Score at 12 Weeks.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.004
72500022|NCT00190775|144530122|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-Value for Inattention Score at 12 Weeks.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||<0.001
72500023|NCT00190775|144530122|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-Value for Total Score at 24 Weeks.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||<0.001
72620647|NCT02037984|144772323|OTHER|PT3 Percentage Point Difference (V114 - Prevnar 13®)|PT3 Percentage Point Difference|18.4|||||TWO_SIDED|95.0|1.7|35.5|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||35.5|1.7|
72620648|NCT02037984|144772323|OTHER|PT4 Percentage Point Difference (V114 - Prevnar 13®)|PT4 Percentage Point Difference|-14.9|||||TWO_SIDED|95.0|-31.4|-1.2|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||-1.2|-31.4|
72620649|NCT02037984|144772323|OTHER|PT5 Percentage Point Difference (V114 - Prevnar 13®)|PT5 Percentage Point Difference|0.0|||||TWO_SIDED|95.0|-10.3|9.5|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||9.5|-10.3|
72620650|NCT02037984|144772323|OTHER|PT6A Percentage Point Difference (V114 - Prevnar 13®)|PT6A Percentage Point Difference|0.0|||||TWO_SIDED|95.0|-10.3|9.5|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||9.5|-10.3|
72562807|NCT03244475|144657389|SUPERIORITY|Statistical analysis was carried out for the DIFFERENCE scores to assess group differences between TES and Sham groups.||||||0.05|||||||Wilcoxon (Mann-Whitney)|Wilcoxon test was chosen due to potential non-normal distribution for the difference scores.||Differences between pre- and post-treatment measures were obtained as difference scores for TES and Sham separately. The null hypothesis was that there was no group difference in the pre- and post-treatment difference scores between TES and Sham groups||||0.05
72562808|NCT03244475|144657390|SUPERIORITY|Statistical analysis was carried out for the DIFFERENCE scores to assess group differences between TES and Sham groups.||||||0.05|||||||Wilcoxon (Mann-Whitney)|Wilcoxon test was chosen due to potential non-normal distribution for the difference scores.||Differences between pre- and post-treatment measures were obtained as difference scores for TES and Sham separately. The null hypothesis was that there was no group difference in the pre- and post-treatment difference scores between TES and Sham groups||||0.05
72562809|NCT03244475|144657391|SUPERIORITY|Statistical analysis was carried out for the difference scores to assess group differences between TES and Sham groups.||||||0.05|||||||Wilcoxon (Mann-Whitney)|Wilcoxon test was chosen due to potential non-normal distribution for the difference scores.||Differences between pre- and post-treatment measures were obtained as difference scores for TES and Sham separately. The null hypothesis was that there was no group difference in the pre- and post-treatment difference scores between TES and Sham groups||||0.05
72562810|NCT03244475|144657392|SUPERIORITY|Statistical analysis was carried out for the difference scores to assess group differences between TES and Sham groups.||||||0.05|||||||Wilcoxon (Mann-Whitney)|Wilcoxon test was chosen due to potential non-normal distribution for the difference scores.||Differences between pre- and post-treatment measures were obtained as difference scores for TES and Sham separately. The null hypothesis was that there was no group difference in the pre- and post-treatment difference scores between TES and Sham groups||||0.05
72391926|NCT00133952|144291069|SUPERIORITY_OR_OTHER||LS Mean difference|-3.3||||0.616|TWO_SIDED|95.0|-16.5|9.8|||Mixed models repeated measures|||||9.8|-16.5|0.616
72391927|NCT00133952|144291070|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.99||||0.971|TWO_SIDED|95.0|0.68|1.44|||Cochran-Mantel-Haenszel|||||1.44|0.68|0.971
72455380|NCT03365622|144434086|SUPERIORITY||Mean Difference (Final Values)|-1.65|STANDARD_ERROR_OF_MEAN|3.007||0.5839|TWO_SIDED|95.0|-7.579|4.28|||Regression, Linear|Adjusted for age, sex, BMI, type of surgery and TAP block.|"The estimate reflects the adjusted difference in mean outcome between arms/groups, with the placebo IV + oral acetaminophen serving as the reference group."|A multiple linear regression model was used to examine the association between treatment assignment and the 20-24 hours post-op inspiratory capacity percentage, adjusting for patient age, gender, body mass index (BMI), type of surgery (laparoscopic donor nephrectomy or laparoscopic nephrectomy for renal cancer), and whether the patient received a TAP block during surgery.||4.28|-7.579|0.5839
72455381|NCT03365622|144434087|SUPERIORITY||Mean Difference (Final Values)|0.399|STANDARD_ERROR_OF_MEAN|0.344||0.2479|TWO_SIDED|95.0|-0.28|1.078|||Regression, Linear|Adjusted for age, sex, BMI, type of surgery and TAP block.|"The estimate reflects the adjusted difference in mean outcome between arms/groups, with the placebo IV + oral acetaminophen serving as the reference group."|A multiple linear regression model was used to examine the association between treatment assignment and the 1-2 hours post-op dynamic pain score, adjusting for patient age, gender, body mass index (BMI), type of surgery (laparoscopic donor nephrectomy or laparoscopic nephrectomy for renal cancer), and whether the patient received a TAP block during surgery.||1.078|-0.280|0.2479
72500024|NCT00190775|144530122|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-Value for Hyperactivity Score at 24 Weeks.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||<0.001
72562811|NCT03244475|144657393|SUPERIORITY|Statistical analysis was carried out for the DIFFERENCE scores to assess group differences between TES and Sham groups.||||||0.05|||||||Wilcoxon (Mann-Whitney)|Wilcoxon test was chosen due to potential non-normal distribution for the difference scores.||Differences between pre- and post-treatment measures were obtained as difference scores for TES and Sham separately. The null hypothesis was that there was no group difference in the pre- and post-treatment difference scores between TES and Sham groups||||0.05
72562812|NCT03244475|144657394|SUPERIORITY|Statistical analysis was carried out for the DIFFERENCE scores to assess group differences between TES and Sham groups.||||||0.05|||||||Wilcoxon (Mann-Whitney)|Wilcoxon test was chosen due to potential non-normal distribution for the difference scores.||Differences between pre- and post-treatment measures were obtained as difference scores for TES and Sham separately. The null hypothesis was that there was no group difference in the pre- and post-treatment difference scores between TES and Sham groups||||0.05
72562813|NCT03244475|144657395|SUPERIORITY|Statistical analysis was carried out for the difference scores to assess group differences between TES and Sham groups.||||||0.05|||||||Wilcoxon (Mann-Whitney)|Wilcoxon test was chosen due to potential non-normal distribution for the difference scores.||Differences between pre- and post-treatment measures were obtained as difference scores for TES and Sham separately. The null hypothesis was that there was no group difference in the pre- and post-treatment difference scores between TES and Sham groups||||0.05
72562814|NCT04894084|144657397|SUPERIORITY||Risk Ratio (RR)|0.18|||<|0.001|TWO_SIDED|95.0|0.07|0.49|||Poisson loglinear model|||||0.49|0.07|<0.001
72620651|NCT02037984|144772323|OTHER|PT6B Percentage Point Difference (V114 - Prevnar 13®)|PT6B Percentage Point Difference|0.0|||||TWO_SIDED|95.0|-10.3|9.5|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||9.5|-10.3|
72620652|NCT02037984|144772323|OTHER|PT7F Percentage Point Difference (V114 - Prevnar 13®)|PT7F Percentage Point Difference|0.0|||||TWO_SIDED|95.0|-10.3|9.5|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||9.5|-10.3|
72620653|NCT02037984|144772323|OTHER|PT9V Percentage Point Difference (V114 - Prevnar 13®)|PT9V Percentage Point Difference|0.0|||||TWO_SIDED|95.0|-10.3|9.5|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||9.5|-10.3|
72391928|NCT00133952|144291072|SUPERIORITY_OR_OTHER||LS Mean difference|0.5||||0.344|TWO_SIDED|95.0|-0.6|1.6|||Mixed models repeated measures|||||1.6|-0.6|0.344
72391929|NCT00133952|144291073|SUPERIORITY_OR_OTHER|||||||0.663||95.0|||||ANCOVA|||||||0.663
72391930|NCT00133952|144291074|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.68||||0.203|TWO_SIDED|95.0|0.37|1.23|||Cochran-Mantel-Haenszel|||||1.23|0.37|0.203
72391931|NCT00133952|144291076|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.16||||0.749|TWO_SIDED|95.0|0.46|2.92|||Cochran-Mantel-Haenszel|||||2.92|0.46|0.749
72391932|NCT02128113|144291086|SUPERIORITY||LS Mean difference (Net)|26.95||||0.4529|TWO_SIDED||||||ANCOVA|Missing data were imputed.|Difference is Omaveloxolone Ophthalmic Suspension (pooled) - Vehicle Ophthalmic Solution|Comparison of Omaveloxolone Ophthalmic Suspension pooled (0.5% and 1.0%) versus Vehicle Ophthalmic Solution||||0.4529
72391933|NCT02128113|144291086|SUPERIORITY||LS Mean difference (Net)|64.31||||0.1276|TWO_SIDED||||||ANCOVA|Missing data were imputed.|Difference is Omaveloxolone Ophthalmic Suspension 0.5% - Vehicle Ophthalmic Solution|Comparison of Omaveloxolone Ophthalmic Suspension 0.5% versus Vehicle Ophthalmic Solution||||0.1276
72391934|NCT02128113|144291086|SUPERIORITY||LS Mean difference (Net)|-11.08||||0.7996|TWO_SIDED||||||ANCOVA|Missing data were imputed.|Difference is Omaveloxolone Ophthalmic Suspension 1.0% - Vehicle Ophthalmic Solution|Comparison of Omaveloxolone Ophthalmic Suspension 1.0% versus Vehicle Ophthalmic Solution||||0.7996
72391935|NCT02128113|144291087|SUPERIORITY||Difference in proportion of patients|-13.55||||0.0647|TWO_SIDED|95.0|-26.75|-0.36|||Cochran-Mantel-Haenszel||Difference is Omaveloxolone Ophthalmic Suspension 0.5% - Vehicle Ophthalmic Solution|Comparison of Omaveloxolone Ophthalmic Suspension 0.5% versus Vehicle Ophthalmic Solution||-0.36|-26.75|0.0647
72391936|NCT02128113|144291087|SUPERIORITY||Difference in proportion of patients|-15.15||||0.0517|TWO_SIDED|95.0|-28.34|-1.96|||Cochran-Mantel-Haenszel||Difference is Omaveloxolone Ophthalmic Suspension 1.0% - Vehicle Ophthalmic Solution|Comparison of Omaveloxolone Ophthalmic Suspension 1.0% versus Vehicle Ophthalmic Solution||-1.96|-28.34|0.0517
72391937|NCT02128113|144291088|SUPERIORITY||Difference in proportion of patients|-0.11||||0.9258|TWO_SIDED|95.0|-8.91|8.68|||Cochran-Mantel-Haenszel||Difference is Omaveloxolone Ophthalmic Suspension 0.5% - Vehicle Ophthalmic Solution|Comparison of Omaveloxolone Ophthalmic Suspension 0.5% versus Vehicle Ophthalmic Solution||8.68|-8.91|0.9258
72391938|NCT02128113|144291088|SUPERIORITY||Difference in proportion of patients|-3.03||||0.6547|TWO_SIDED|95.0|-12.27|6.21|||Cochran-Mantel-Haenszel||Difference is Omaveloxolone Ophthalmic Suspension 1.0% - Vehicle Ophthalmic Solution|Comparison of Omaveloxolone Ophthalmic Suspension 1.0% versus Vehicle Ophthalmic Solution||6.21|-12.27|0.6547
72455382|NCT03365622|144434088|SUPERIORITY||Mean Difference (Final Values)|0.484|STANDARD_ERROR_OF_MEAN|0.335||0.1502|TWO_SIDED|95.0|-0.177|1.145|||Regression, Linear|Adjusted for age, sex, BMI, type of surgery and TAP block.|"The estimate reflects the adjusted difference in mean outcome between arms/groups, with the placebo IV + oral acetaminophen serving as the reference group."|A multiple linear regression model was used to examine the association between treatment assignment and the 20-24 hours post-op dynamic pain score, adjusting for patient age, gender, body mass index (BMI), type of surgery (laparoscopic donor nephrectomy or laparoscopic nephrectomy for renal cancer), and whether the patient received a TAP block during surgery.||1.145|-0.177|0.1502
72455383|NCT03365622|144434089|SUPERIORITY||Mean Difference (Final Values)|0.339|STANDARD_ERROR_OF_MEAN|0.313||0.2797|TWO_SIDED|95.0|-0.278|0.955|||Regression, Linear|Adjusted for age, sex, BMI, type of surgery and TAP block.|"The estimate reflects the adjusted difference in mean outcome between arms/groups, with the placebo IV + oral acetaminophen serving as the reference group."|A multiple linear regression model was used to examine the association between treatment assignment and the 20-24 hours post-op surgical pain score, adjusting for patient age, gender, body mass index (BMI), type of surgery (laparoscopic donor nephrectomy or laparoscopic nephrectomy for renal cancer), and whether the patient received a TAP block during surgery.||0.955|-0.278|0.2797
72391939|NCT02128113|144291089|SUPERIORITY||Difference in proportion of patients|-13.56||||0.0657|TWO_SIDED|95.0|-26.84|-0.28|||Cochran-Mantel-Haenszel||Difference is Omaveloxolone Ophthalmic Suspension 0.5% - Vehicle Ophthalmic Solution|Comparison of Omaveloxolone Ophthalmic Suspension 0.5% versus Vehicle Ophthalmic Solution||-0.28|-26.84|0.0657
72391940|NCT02128113|144291089|SUPERIORITY|Comparison of Omaveloxolone Ophthalmic Suspension 1.0% versus Vehicle Ophthalmic Solution|Difference in proportion of patients|-15.15||||0.0526|TWO_SIDED|95.0|-28.42|-1.88|||Cochran-Mantel-Haenszel||Difference is Omaveloxolone Ophthalmic Suspension 1.0% - Vehicle Ophthalmic Solution|||-1.88|-28.42|0.0526
72391941|NCT02128113|144291090|SUPERIORITY||Difference in proportion of patients|0.0||||0.8771|TWO_SIDED|95.0|-10.87|10.87|||Cochran-Mantel-Haenszel||Difference is Omaveloxolone Ophthalmic Suspension 0.5% - Vehicle Ophthalmic Solution|Comparison of Omaveloxolone Ophthalmic Suspension 0.5% versus Vehicle Ophthalmic Solution||10.87|-10.87|0.8771
72391942|NCT02128113|144291090|SUPERIORITY||Difference in proportion of patients|1.35||||0.8248|TWO_SIDED|95.0|-9.32|12.02|||Cochran-Mantel-Haenszel||Difference is Omaveloxolone Ophthalmic Suspension 1.0% - Vehicle Ophthalmic Solution|Comparison of Omaveloxolone Ophthalmic Suspension 1.0% versus Vehicle Ophthalmic Solution||12.02|-9.32|0.8248
72391943|NCT02128113|144291091|SUPERIORITY||LS Mean difference (Net)|27.21||||0.4686|TWO_SIDED||||||ANCOVA|Missing data were imputed.||Comparison of Omaveloxolone Ophthalmic Suspension pooled (0.5% and 1.0%) versus Vehicle Ophthalmic Solution||||0.4686
72391944|NCT02128113|144291091|SUPERIORITY||LS Mean difference (Net)|49.99||||0.2636|TWO_SIDED||||||ANCOVA|Missing data were imputed.||Comparison of Omaveloxolone Ophthalmic Suspension 0.5% versus Vehicle Ophthalmic Solution||||0.2636
72391945|NCT02128113|144291091|SUPERIORITY||LS Mean difference (Net)|-1.74||||0.9691|TWO_SIDED||||||ANCOVA|Missing data were imputed.||Comparison of Omaveloxolone Ophthalmic Suspension 1.0% versus Vehicle Ophthalmic Solution||||0.9691
72391946|NCT00299104|144291108|SUPERIORITY_OR_OTHER|||||||0.0016||95.0||||The Closure Principle was used to adjust for multiple comparisons.|Kruskal-Wallis|||Comparing all three treatment groups||||0.0016
72391947|NCT00299104|144291108|SUPERIORITY_OR_OTHER|||||||0.1824||95.0||||The Closure Principle was used to adjust for multiple comparisons.|Van-Elteren|||Rituximab 2 x 0.5 g + Methotrexate arm versus Placebo + Methotrexate, stratified for region and baseline rheumatoid factor (RF) status||||0.1824
72391948|NCT00299104|144291108|SUPERIORITY_OR_OTHER|||||||0.0004||95.0||||The Closure Principle was used to adjust for multiple comparisons.|Van-Elteren|||Rituximab 2 x 1.0 g + Methotrexate arm versus Placebo + Methotrexate, stratified for region and baseline RF status||||0.0004
72391949|NCT00299104|144291109|SUPERIORITY_OR_OTHER|||||||0.0004||95.0||||The Closure Principle was used to adjust for multiple comparisons. This was a secondary endpoint in a hierarchical testing structure.|Kruskal-Wallis|||Comparing all three treatment groups||||0.0004
72391950|NCT00299104|144291109|SUPERIORITY_OR_OTHER|||||||0.1194||95.0||||The Closure Principle was used to adjust for multiple comparisons. This was a secondary endpoint in a hierarchical testing structure.|Van-Elteren|||Rituximab 2 x 0.5 g + Methotrexate versus Placebo + Methotrexate, stratified for region and baseline RF status||||0.1194
72562815|NCT04894084|144657398|OTHER||Exact test in the binomial distribution|91.3|||<|0.0001|TWO_SIDED|95.0|72.0|99.0||"Low degree + Very low degree / Not at all were tested against the rest of the answers in this analysis."|Exact test in the binomial distribution|||"For secondary endpoints where the possible answer is Yes or No, the proportion of subjects answering Yes was calculated. By use of an exact test in the binomial distribution a 95% confidence interval was estimated for the proportion. It was tested if the proportion was significantly different from 50% when using a 5% test level. For questions answered on a 5-point scale the answers was grouped in 2 (e.g. higher or much higher against the rest of the answers)."||99|72|<0.0001
72562816|NCT04894084|144657399|OTHER||Exact test in the binomial distribution|78.3||||0.0106|TWO_SIDED|95.0|56.0|93.0||"Some degree, High degree and Very high degree were tested against the rest of the answers in this analysis."|Exact test in the binomial distribution|||For secondary endpoints an exact test in the binomial distribution a 95% confidence interval was estimated for the proportion. It was tested if the proportion was significantly different from 50% when using a 5% test level. For reliability answered on a 5-point scale the answers some, high, or very high degree was considered acceptable and grouped against answers of 'low or very low' degree of reliability.||93|56|0.0106
72562817|NCT04894084|144657400|OTHER||Exact test in the binomial distribution|95.7|||<|0.0001|TWO_SIDED|95.0|78.0|100.0||"Same, Better and Much better were tested against the rest of the answers in this analysis."|Exact test in the binomial distribution|||For secondary endpoints an exact test in the binomial distribution a 95% confidence interval was estimated for the proportion. For ability to move with test product it was tested if the proportion evaluating same or better was significantly different from 50% when using a 5% test level. The answers of 'same, better or much better' was grouped against the answers of 'worse or much worse' ability to move.||100|78|<0.0001
72562818|NCT04894084|144657401|OTHER|Users worry of leakage given on a 5-point scale was analyzed by a proportional odds ratio model taken the paired design into consideration to compare the results from V1 and V2.|||||<|0.001|||||||Proportional odds ratio model|||||||<0.001
72562819|NCT04894084|144657402|OTHER|"For secondary endpoints where the possible answer is Yes or No, the proportion of subjects answering Yes was calculated. By use of an exact test in the binomial distribution a 95% confidence interval was estimated for the proportion. It was tested if the proportion was significantly different from 50% when using a 5% test level."|Exact test in the binomial distribution|78.3||||0.0106|TWO_SIDED|95.0|56.0|93.0|||Exact test in the binomial distribution|||||93|56|0.0106
72562820|NCT04894084|144657403|OTHER|"For secondary endpoints where the possible answer is Yes or No, the proportion of subjects answering Yes was calculated. By use of an exact test in the binomial distribution a 95% confidence interval was estimated for the proportion. It was tested if the proportion was significantly different from 50% when using a 5% test level. For questions answered on a 5-point scale the answers was grouped in 2 (e.g. higher or much higher against the rest of the answers)."|Exact test in the binomial distribution|65.2||||0.21|TWO_SIDED|95.0|43.0|84.0||"Higher degree and Much higher degree were tested against the rest of the answers in this analysis."|Exact test in the binomial distribution|||||84|43|0.21
72562821|NCT04894084|144657404|OTHER|"For secondary endpoints where the possible answer is Yes or No, the proportion of subjects answering Yes was calculated. By use of an exact test in the binomial distribution a 95% confidence interval was estimated for the proportion. It was tested if the proportion was significantly different from 50% when using a 5% test level. For questions answered on a 5-point scale the answers was grouped in 2 (e.g. higher or much higher against the rest of the answers)."|Exact test in the binomial distribution|78.3||||0.0106|TWO_SIDED|95.0|56.0|93.0|||Exact test in the binomial distribution|||||93|56|0.0106
72562822|NCT04894084|144657405|OTHER|"For secondary endpoints where the possible answer is Yes or No, the proportion of subjects answering Yes was calculated. By use of an exact test in the binomial distribution a 95% confidence interval was estimated for the proportion. It was tested if the proportion was significantly different from 50% when using a 5% test level."|Exact test in the binomial distribution|69.6||||0.093|TWO_SIDED|95.0|47.0|87.0|||Exact test in the binomial distribution|||||87|47|0.093
72562823|NCT04894084|144657406|OTHER|By use of an exact test in the binomial distribution a 95% confidence interval was estimated for the proportion. It was tested if the proportion with a positive response was significantly different from 50% when using a 5% test level.|Exact test in the binomial distribution|95.7|||<|0.0001|TWO_SIDED|95.0|78.0|100.0|||Exact test in the binomial distribution|||||100|78|<0.0001
72562824|NCT04894084|144657407|OTHER|By use of an exact test in the binomial distribution a 95% confidence interval was estimated for the proportion. It was tested if the proportion answering I felt more confident was significantly different from 50% when using a 5% test level.|Exact test in the binomial distribution|91.3|||<|0.0001|TWO_SIDED|95.0|72.0|99.0|||Exact test in the binomial distribution|||||99|72|<0.0001
72562825|NCT04894084|144657408|OTHER|"For secondary endpoints where the possible answer is Yes or No, the proportion of subjects answering Yes was calculated. By use of an exact test in the binomial distribution a 95% confidence interval was estimated for the proportion. It was tested if the proportion was significantly different from 50% when using a 5% test level. For questions answered on a 5-point scale the answers was grouped in 2 (e.g. higher or much higher against the rest of the answers)."|Exact test in the binomial distribution|34.8||||0.21|TWO_SIDED|95.0|16.0|57.0||"Yes, to the better was tested against the rest of the answers in this analysis."|Exact test in the binomial distribution|||||57|16|0.21
72562826|NCT04894084|144657409|OTHER|"For secondary endpoints where the possible answer is Yes or No, the proportion of subjects answering Yes was calculated. By use of an exact test in the binomial distribution a 95% confidence interval was estimated for the proportion. It was tested if the proportion was significantly different from 50% when using a 5% test level. For questions answered on a 5-point scale the answers was grouped in 2 (e.g. higher or much higher against the rest of the answers)."|Exact test in the binomial distribution|47.8||||1|TWO_SIDED|95.0|27.0|69.0||"Higher degree and Much higher degree were tested against the rest of the answers in this analysis."|Exact test in the binomial distribution|||||69|27|1.00
72562827|NCT04894084|144657410|OTHER|"For secondary endpoints where the possible answer is Yes or No, the proportion of subjects answering Yes was calculated. By use of an exact test in the binomial distribution a 95% confidence interval was estimated for the proportion. It was tested if the proportion was significantly different from 50% when using a 5% test level."|Exact test in the binomial distribution|56.5||||0.678|TWO_SIDED|95.0|34.0|77.0|||Exact test in the binomial distribution|||||77|34|0.678
72620654|NCT02037984|144772323|OTHER|PT14 Percentage Point Difference (V114 - Prevnar 13®)|PT14 Percentage Point Difference|0.0|||||TWO_SIDED|95.0|-10.3|9.5|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||9.5|-10.3|
72370386|NCT01708902|144251469|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.51|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001|TWO_SIDED|95.0|-0.73|-0.29|||ANCOVA||The adjusted mean difference was calculated as the adjusted mean of 'Main: Linagliptin 2.5mg / Metformin 500mg BID' minus 'Main: Metformin 500mg BID'.|"The model includes treatment as a fixed effect and baseline HbA1c as a linear covariate.~The null and alternative hypotheses were tested in a hierarchical sequence. The next null hypothesis was tested in a confirmatory way only if all prior null-hypotheses were rejected. 'Greater effect' refers to a greater reduction in HbA1c."||-0.29|-0.73|<0.0001
72391951|NCT00299104|144291109|SUPERIORITY_OR_OTHER|||||||0.0001||95.0||||The Closure Principle was used to adjust for multiple comparisons. This was a secondary endpoint in a hierarchical testing structure.|Van-Elteren|||Rituximab 2 x 1.0 g + Methotrexate versus Placebo + Methotrexate, stratified for region and baseline RF status||||0.0001
72391952|NCT00299104|144291110|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.04||||0.3803||95.0|-0.05|0.13||This was a secondary endpoint in a hierarchical testing structure.|Cochran-Mantel-Haenszel|||Rituximab 2 x 0.5 g + Methotrexate arm versus Placebo + Methotrexate, stratified for region and baseline RF status||0.13|-0.05|0.3803
72391953|NCT00299104|144291110|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.1||||0.0309||95.0|0.01|0.18||This was a secondary endpoint in a hierarchical testing structure.|Cochran-Mantel-Haenszel|||Rituximab 2 x 1.0 g + Methotrexate arm versus Placebo + Methotrexate, stratified for region and baseline RF status||0.18|0.01|0.0309
72455384|NCT03365622|144434090|SUPERIORITY||Mean Difference (Final Values)|-0.333|STANDARD_ERROR_OF_MEAN|0.739||0.6527|TWO_SIDED|95.0|-1.792|1.125|||Regression, Linear|Adjusted for age, sex, BMI, type of surgery and TAP block.|"The estimate reflects the adjusted difference in mean outcome between arms/groups, with the placebo IV + oral acetaminophen serving as the reference group."|A multiple linear regression model was used to examine the association between treatment assignment and time to first narcotic use, adjusting for patient age, gender, body mass index (BMI), type of surgery (laparoscopic donor nephrectomy or laparoscopic nephrectomy for renal cancer), and whether the patient received a TAP block during surgery.||1.125|-1.792|0.6527
72500025|NCT00190775|144530122|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-Value for Inattention Score at 24 Weeks.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||<0.001
72620655|NCT02037984|144772323|OTHER|PT18C Percentage Point Difference (V114 - Prevnar 13®)|PT18C Percentage Point Difference|0.0|||||TWO_SIDED|95.0|-10.3|9.5|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||9.5|-10.3|
72620656|NCT02037984|144772323|OTHER|PT19A Percentage Point Difference (V114 - Prevnar 13®)|PT19A Percentage Point Difference|0.0|||||TWO_SIDED|95.0|-10.3|9.5|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||9.5|-10.3|
72620657|NCT02037984|144772323|OTHER|PT19F Percentage Point Difference (V114 - Prevnar 13®)|PT19F Percentage Point Difference|0.0|||||TWO_SIDED|95.0|-10.3|9.5|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||9.5|-10.3|
72370387|NCT01708902|144251469|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.87|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001|TWO_SIDED|95.0|-1.09|-0.64|||ANCOVA||The adjusted mean difference was calculated as the adjusted mean of 'Main: Linagliptin 2.5mg / Metformin 500mg BID' minus 'Main: Linagliptin 5mg QD'.|"The model includes treatment as a fixed effect and baseline HbA1c as a linear covariate.~The null and alternative hypotheses were tested in a hierarchical sequence. The next null hypothesis was tested in a confirmatory way only if all prior null-hypotheses were rejected. 'Greater effect' refers to a greater reduction in HbA1c."||-0.64|-1.09|<0.0001
72370388|NCT01708902|144251470|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.673|STANDARD_ERROR_OF_MEAN|0.487||0.0771|TWO_SIDED|95.0|0.946|2.961|||Regression, Logistic|||"Comparison of 'Main: Linagliptin 2.5mg / Metformin 1000mg BID' / 'Main: Metformin 1000mg BID'.~The logistic regression includes treatment and continuous baseline HbA1c."||2.961|0.946|0.0771
72370389|NCT01708902|144251470|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.489|STANDARD_ERROR_OF_MEAN|1.543|<|0.0001|TWO_SIDED|95.0|3.164|9.522|||Regression, Logistic|||"Comparison of 'Main: Linagliptin 2.5mg / Metformin 1000mg BID' / 'Main: Linagliptin 5mg QD'.~The logistic regression includes treatment and continuous baseline HbA1c."||9.522|3.164|<0.0001
72370390|NCT01708902|144251470|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.829|STANDARD_ERROR_OF_MEAN|0.753|<|0.0001|TWO_SIDED|95.0|1.678|4.767|||Regression, Logistic|||"Comparison of 'Main: Linagliptin 2.5mg / Metformin 500mg BID' / 'Main: Metformin 500mg BID'.~The logistic regression includes treatment and continuous baseline HbA1c."||4.767|1.678|<0.0001
72370391|NCT01708902|144251470|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.818|STANDARD_ERROR_OF_MEAN|1.023|<|0.0001|TWO_SIDED|95.0|2.259|6.454|||Regression, Logistic|||"Comparison of 'Main: Linagliptin 2.5mg / Metformin 500mg BID' / 'Main: Linagliptin 5mg QD'.~The logistic regression includes treatment and continuous baseline HbA1c."||6.454|2.259|<0.0001
72370392|NCT01708902|144251471|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.169|STANDARD_ERROR_OF_MEAN|1.565||0.0001|TWO_SIDED|95.0|1.997|8.701|||Regression, Logistic|||"Comparison of 'APG: Linagliptin 2.5mg / Metformin 1000mg BID' / 'APG: Linagliptin 5mg QD'.~The logistic regression includes treatment and continuous baseline HbA1c."||8.701|1.997|0.0001
72370393|NCT01708902|144251472|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.661|STANDARD_ERROR_OF_MEAN|0.426||0.048|TWO_SIDED|95.0|1.004|2.746|||Regression, Logistic|||"Comparison of 'Main: Linagliptin 2.5mg / Metformin 1000mg BID' / 'Main: Metformin 1000mg BID'.~The logistic regression includes treatment and continuous baseline HbA1c."||2.746|1.004|0.0480
72370394|NCT01708902|144251472|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.923|STANDARD_ERROR_OF_MEAN|1.632|<|0.0001|TWO_SIDED|95.0|3.452|10.164|||Regression, Logistic|||"Comparison of 'Main: Linagliptin 2.5mg / Metformin 1000mg BID' / 'Main: Linagliptin 5mg QD'.~The logistic regression includes treatment and continuous baseline HbA1c."||10.164|3.452|<0.0001
72370395|NCT01708902|144251472|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.574|STANDARD_ERROR_OF_MEAN|0.655||0.0002|TWO_SIDED|95.0|1.563|4.239|||Regression, Logistic|||"Comparison of 'Main: Linagliptin 2.5mg / Metformin 500mg BID' / 'Main: Metformin 500mg BID'.~The logistic regression includes treatment and continuous baseline HbA1c."||4.239|1.563|0.0002
72370396|NCT01708902|144251472|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.682|STANDARD_ERROR_OF_MEAN|1.27|<|0.0001|TWO_SIDED|95.0|2.751|7.968|||Regression, Logistic|||"Comparison of 'Main: Linagliptin 2.5mg / Metformin 500mg BID' / 'Main: Linagliptin 5mg QD'.~The logistic regression includes treatment and continuous baseline HbA1c."||7.968|2.751|<0.0001
72455385|NCT03365622|144434091|SUPERIORITY||Odds Ratio (OR)|0.465||||0.0499|TWO_SIDED|95.0|0.217|1.0|||Regression, Logistic|Adjusted for age, sex, BMI, type of surgery and TAP block.||A logistic regression model was used to examine the association between treatment assignment and incidence of nausea, adjusting for patient age, gender, body mass index (BMI), type of surgery (laparoscopic donor nephrectomy or laparoscopic nephrectomy for renal cancer), and whether the patient received a TAP block during surgery.||1.000|0.217|0.0499
72455386|NCT03365622|144434092|SUPERIORITY||Mean Difference (Final Values)|24.492|STANDARD_ERROR_OF_MEAN|18.165||0.179|TWO_SIDED|95.0|-11.321|60.304|||Regression, Linear|Adjusted for age, sex, BMI, type of surgery and TAP block.|"The estimate reflects the adjusted difference in mean outcome between arms/groups, with the placebo IV + oral acetaminophen serving as the reference group."|A multiple linear regression model was used to examine the association between treatment assignment and time to discharge from PACU, adjusting for patient age, gender, body mass index (BMI), type of surgery (laparoscopic donor nephrectomy or laparoscopic nephrectomy for renal cancer), and whether the patient received a TAP block during surgery.||60.304|-11.321|0.179
72455387|NCT03365622|144434093|SUPERIORITY||Mean Difference (Final Values)|0.274|STANDARD_ERROR_OF_MEAN|0.253||0.2811|TWO_SIDED|95.0|-0.226|0.773|||Regression, Linear|Adjusted for age, sex, BMI, type of surgery and TAP block.|"The estimate reflects the adjusted difference in mean outcome between arms/groups, with the placebo IV + oral acetaminophen serving as the reference group."|A multiple linear regression model was used to examine the association between treatment assignment and time to hospital discharge, adjusting for patient age, gender, body mass index (BMI), type of surgery (laparoscopic donor nephrectomy or laparoscopic nephrectomy for renal cancer), and whether the patient received a TAP block during surgery.||0.773|-0.226|0.2811
72455388|NCT02609048|144434101|SUPERIORITY||Difference in LSM|-60.99|STANDARD_ERROR_OF_MEAN|5.814|<|0.0001|TWO_SIDED|95.0|-72.85|-49.13||Difference in mean,p-value, and CIs estimated by comparing Seladelpar level with placebo by ANCOVA model.Treatment group as factor,baseline AP assessment as covariate,and percent change from baseline as response variable.|ANCOVA|||||-49.13|-72.85|<0.0001
72455389|NCT02609048|144434101|SUPERIORITY||Difference in Least Squares Mean (LSM)|-51.37|STANDARD_ERROR_OF_MEAN|5.849|<|0.0001|TWO_SIDED|95.0|-63.3|-39.44||Difference in mean,p-value, and confidence intervals (CIs) estimated by comparing Seladelpar level with placebo by ANCOVA model.Treatment group as factor,baseline AP assessment as covariate,and percent change from baseline as response variable.|ANCOVA|||||-39.44|-63.30|<0.0001
72455390|NCT02609048|144434101|SUPERIORITY||Difference in Least Squares Mean (LSM)|-9.62|STANDARD_ERROR_OF_MEAN|5.963||0.1167|TWO_SIDED|95.0|-21.79|2.54||Difference in mean,p-value, and CIs estimated by comparing Seladelpar 200 mg versus 50 mg by ANCOVA model.Treatment group as factor,baseline AP assessment as covariate,and percent change from baseline as response variable.|ANCOVA|||||2.54|-21.79|0.1167
72455391|NCT02609048|144434102|SUPERIORITY||||||<|0.0001||||||The p-values were calculated from Fisher's exact test comparing each Seladelpar group with Placebo separately.|Fisher Exact|||||||<0.0001
72455392|NCT02609048|144434102|SUPERIORITY|||||||0.0036||||||The p-values were calculated from Fisher's exact test comparing each Seladelpar group with Placebo separately.|Fisher Exact|||||||0.0036
72455393|NCT02609048|144434102|SUPERIORITY|||||||0.1045||||||The p-values were calculated from Fisher's exact test comparing Seladelpar 200mg versus 50 mg.|Fisher Exact|||||||0.1045
72562828|NCT04894084|144657412|OTHER|"For secondary endpoints where the possible answer is Yes or No, the proportion of subjects answering Yes was calculated. By use of an exact test in the binomial distribution a 95% confidence interval was estimated for the proportion. It was tested if the proportion was significantly different from 50% when using a 5% test level. For questions answered on a 5-point scale the answers was grouped in 2 (e.g. higher or much higher against the rest of the answers)."|Exact test in the binomial distribution|69.6||||0.0931|TWO_SIDED|95.0|47.0|87.0||"High degree and Very high degree were tested against the rest of the answers in this analysis."|Exact test in the binomial distribution|||||87|47|0.0931
72562829|NCT04894084|144657413|OTHER|"For secondary endpoints where the possible answer is Yes or No, the proportion of subjects answering Yes was calculated. By use of an exact test in the binomial distribution a 95% confidence interval was estimated for the proportion. It was tested if the proportion was significantly different from 50% when using a 5% test level."|Exact test in the binomial distribution|87.0||||0.0005|TWO_SIDED|95.0|66.0|97.0|||Exact test in the binomial distribution|||||97|66|0.0005
72562830|NCT02000531|144657416|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.26|||>|0.05|TWO_SIDED|95.0|0.61|2.62|||Log Rank|||||2.62|0.61|>0.05
72562831|NCT00317642|144657424|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.0||||0.9951|TWO_SIDED|95.0|0.78|1.28|||Log Rank|||Full Analysis Set (FAS) population||1.28|0.78|0.9951
72562832|NCT00317642|144657424|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.13||||0.4674|TWO_SIDED|95.0|0.81|1.57|||Log Rank|||Participants stratified by calculated strata remission after first pre-study induction regimen (CR1) \< 6 months||1.57|0.81|0.4674
72562833|NCT00317642|144657424|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.85||||0.3963|TWO_SIDED|95.0|0.58|1.24|||Log Rank|||Participants stratified by calculated strata CR1\>= 6 months||1.24|0.58|0.3963
72562834|NCT00317642|144657425|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Cochran-Mantel-Haenszel|||Full Analysis Set (FAS) population - overall remission (OR)||||<0.0001
72562835|NCT00317642|144657425|SUPERIORITY_OR_OTHER|||||||0.0005||95.0|||||Cochran-Mantel-Haenszel|||Full Analysis Set (FAS) population - Complete Remission (CR)||||0.0005
72455394|NCT02609048|144434103|SUPERIORITY||Difference in LSM|234.71|STANDARD_ERROR_OF_MEAN|104.647||0.0322|TWO_SIDED|95.0|21.28|448.14||Difference between means, p-value, and CIs are estimated by comparing each Seladelpar level with placebo using ANCOVA model.Treatment group as factor, baseline AST assessment as covariate,and percent change from baseline in AST as response variable.|ANCOVA|||||448.14|21.28|0.0322
72562836|NCT00317642|144657425|SUPERIORITY_OR_OTHER|||||||0.0022||95.0|||||Fisher Exact|||Participants stratified by calculated strata - CR1 \<6 months \[Overall Remission (CR+CRi)\]||||0.0022
72562837|NCT00317642|144657425|SUPERIORITY_OR_OTHER|||||||0.0019||95.0|||||Fisher Exact|||Participants stratified by calculated strata - CR1 \>=6 months \[Overall Remission (CR+CRi)\]||||0.0019
72562838|NCT00317642|144657425|SUPERIORITY_OR_OTHER|||||||0.0353||95.0|||||Fisher Exact|||Participants stratified by calculated strata - CR1 \<6 months \[Complete Remission (CR)\]||||0.0353
72562839|NCT00317642|144657425|SUPERIORITY_OR_OTHER|||||||0.0096||95.0|||||Fisher Exact|||Participants stratified by calculated strata - CR1 \>=6 months \[Complete Remission (CR)\]||||0.0096
72455395|NCT02609048|144434103|SUPERIORITY||Difference in LSM|132.82|STANDARD_ERROR_OF_MEAN|96.015||0.1764|TWO_SIDED|95.0|-63.0|328.65||Difference between means, p-value, and CIs are estimated by comparing each Seladelpar level with placebo using ANCOVA model.Treatment group as factor, baseline AST assessment as covariate,and percent change from baseline in AST as response variable.|ANCOVA|||||328.65|-63.00|0.1764
72455396|NCT02609048|144434103|SUPERIORITY||Difference in LSM|101.88|STANDARD_ERROR_OF_MEAN|103.504||0.3326|TWO_SIDED|95.0|-109.21|312.98||Difference between means, p-value, and CIs are estimated by comparing Seladelpar 200 mg versus 50 mg using ANCOVA model.Treatment group as factor, baseline AST assessment as covariate, and percent change from baseline in AST as response variable.|ANCOVA|||||312.98|-109.21|0.3326
72500026|NCT00190775|144530123|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-Value for 8 Weeks.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||<0.001
72500027|NCT00190775|144530123|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-Value for 24 Weeks.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||<0.001
72562840|NCT00317642|144657430|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.63||||0.0001|TWO_SIDED|95.0|0.49|0.8|||Log Rank|||Full Analysis Set (FAS) population.||0.80|0.49|0.0001
72620658|NCT02037984|144772323|OTHER|PT23F Percentage Point Difference (V114 - Prevnar 13®)|PT23F Percentage Point Difference|-5.9|||||TWO_SIDED|95.0|-19.2|3.9|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||3.9|-19.2|
72391954|NCT00299104|144291111|SUPERIORITY_OR_OTHER|||||||0.3752||95.0||||This was a secondary endpoint in a hierarchical testing structure.|Cochran-Mantel-Haenszel|||Rituximab (0.5 g x 2) + Methotrexate versus Placebo + Methotrexate, stratified for region and baseline RF status.||||0.3752
72500028|NCT00190775|144530124|SUPERIORITY_OR_OTHER|||||||0.553||95.0||||P-Value for 12 Weeks.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.553
72500029|NCT00190775|144530124|SUPERIORITY_OR_OTHER|||||||0.797||95.0||||P-Value for 24 Weeks.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.797
72500030|NCT00190775|144530125|SUPERIORITY_OR_OTHER|||||||0.108||95.0||||P-Value for State Anxiety Score at 12 Weeks.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.108
72500031|NCT00190775|144530125|SUPERIORITY_OR_OTHER|||||||0.026||95.0||||P-Value for Trait Anxiety Score at 12 Weeks.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.026
72500032|NCT00190775|144530125|SUPERIORITY_OR_OTHER|||||||0.897||95.0||||P-Value is for State Anxiety Score at 24 Weeks.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.897
72500033|NCT00190775|144530125|SUPERIORITY_OR_OTHER|||||||0.171||95.0||||P-Value is for Trait Anxiety Score at 24 weeks.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.171
72500034|NCT00190775|144530126|SUPERIORITY_OR_OTHER|||||||0.892||95.0||||P-Value for Total ADHD Symptoms Score.|ANCOVA|Model included visit by therapy, pooled investigator, child with ADHD, and baseline.||||||0.892
72500035|NCT00190775|144530126|SUPERIORITY_OR_OTHER|||||||0.003||95.0||||P-Value for Total ADHD Symptoms Score.|ANCOVA|Model included visit by therapy, pooled investigator, child with ADHD, and baseline.||||||0.003
72500036|NCT00190775|144530126|SUPERIORITY_OR_OTHER|||||||0.007||95.0||||P-Value for Total ADHD Symptoms Score.|ANCOVA|Model included visit by therapy, pooled investigator, child with ADHD, and baseline.||||||0.007
72391955|NCT00299104|144291111|SUPERIORITY_OR_OTHER|||||||0.0081||95.0||||This was a secondary endpoint in a hierarchical testing structure.|Cochran-Mantel-Haenszel|||Rituximab (1.0 g x 2) + Methotrexate verus Placebo + Methotrexate, stratified for region and Baseline RF status.||||0.0081
72500037|NCT00190775|144530126|SUPERIORITY_OR_OTHER|||||||0.533||95.0||||P-Value for Hyper/Impulsive Subscale.|ANCOVA|Model included visit by therapy, pooled investigator, child with ADHD, and baseline.||||||0.533
72620659|NCT02037984|144772323|OTHER|non-PT22F Percentage Point Difference (V114 - Prevnar 13®)|non-PT22F Percentage Point Difference|89.2|||||TWO_SIDED|95.0|75.2|95.7|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||95.7|75.2|
72500038|NCT00190775|144530126|SUPERIORITY_OR_OTHER|||||||0.054||95.0||||P-Value for Hyper/Impulsive Subscale.|ANCOVA|Model included visit by therapy, pooled investigator, child with ADHD, and baseline.||||||0.054
72500039|NCT00190775|144530126|SUPERIORITY_OR_OTHER|||||||0.012||95.0||||P-Value for Hyper/Impulsive Subscale.|ANCOVA|Model included visit by therapy, pooled investigator, child with ADHD, and baseline.||||||0.012
72500040|NCT00190775|144530126|SUPERIORITY_OR_OTHER|||||||0.457||95.0||||P-Value for Inattention Subscale.|ANCOVA|Model included visit by therapy, pooled investigator, child with ADHD, and baseline.||||||0.457
72500041|NCT00190775|144530126|SUPERIORITY_OR_OTHER|||||||0.001||95.0||||P-Value for Inattention Subscale.|ANCOVA|Model included visit by therapy, pooled investigator, child with ADHD, and baseline.||||||0.001
72500042|NCT00190775|144530126|SUPERIORITY_OR_OTHER|||||||0.021||95.0||||P-Value for Inattention Subscale.|ANCOVA|Model included visit by therapy, pooled investigator, child with ADHD, and baseline.||||||0.021
72500043|NCT00190775|144530126|SUPERIORITY_OR_OTHER|||||||0.71||95.0||||P-Value for ADHD Index Subscale.|ANCOVA|Model included visit by therapy, pooled investigator, child with ADHD, and baseline.||||||0.710
72500044|NCT00190775|144530126|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-Value for ADHD Index Subscale.|ANCOVA|Model included visit by therapy, pooled investigator, child with ADHD, and baseline.||||||<0.001
72500045|NCT00190775|144530126|SUPERIORITY_OR_OTHER|||||||0.005||95.0||||P-Value for ADHD Index Subscale.|ANCOVA|Model included visit by therapy, pooled investigator, child with ADHD, and baseline.||||||0.005
72562841|NCT00317642|144657430|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.67||||0.0131|TWO_SIDED|95.0|0.49|0.93|||Log Rank|Comparison P-value is from a log-rank test with no strata||Participants stratified by randomization strata CR1 \<6 months||0.93|0.49|0.0131
72562842|NCT00317642|144657430|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.57||||0.0022||95.0|0.4|0.83|||Log Rank|Comparison p-value is from a log-rank test with no strata.||Participants stratified by randomization strata CR1 \>=6 months||0.83|0.40|0.0022
72562843|NCT00317642|144657431|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.97||||0.8209|TWO_SIDED|95.0|0.77|1.23|||Log Rank|||Full Analysis Set (FAS) population||1.23|0.77|0.8209
72620660|NCT02037984|144772323|OTHER|non-PT33F Percentage Point Difference (V114 - Prevnar 13®)|non-PT33F Percentage Point Difference|97.3|||||TWO_SIDED|95.0|85.9|99.5|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||99.5|85.9|
72455397|NCT02609048|144434104|SUPERIORITY||Difference in LSM|185.78|STANDARD_ERROR_OF_MEAN|104.379||0.0849|TWO_SIDED|95.0|-27.1|398.66||Difference between means,p-value, and CIs are estimated by comparing each Seladelpar level with placebo using ANCOVA model.Treatment group as a factor, baseline ALT assessment as covariate,and percent change from baseline in ALT as response variable.|ANCOVA|||||398.66|-27.10|0.0849
72455398|NCT02609048|144434104|SUPERIORITY||Difference in LSM|116.5|STANDARD_ERROR_OF_MEAN|97.437||0.2409|TWO_SIDED|95.0|-82.22|315.23||Difference between means,p-value,and CIs are estimated by comparing each Seladelpar level with placebo using ANCOVA model.Treatment group as a factor,baseline ALT assessment as covariate, and percent change from baseline in ALT as response variable.|ANCOVA|||||315.23|-82.22|0.2409
72455399|NCT02609048|144434104|SUPERIORITY||Difference in LSM|69.28|STANDARD_ERROR_OF_MEAN|105.295||0.5154|TWO_SIDED|95.0|-145.47|284.03||Difference between means,p-value,and CIs are estimated by comparing Seladelpar 200 mg versus 50 mg using ANCOVA model.Treatment group as a factor,baseline ALT assessment as covariate, and percent change from baseline in ALT as response variable.|ANCOVA|||||284.03|-145.47|0.5154
72455400|NCT02609048|144434105|SUPERIORITY||Difference in LSM|-45.34|STANDARD_ERROR_OF_MEAN|12.112||0.0007|TWO_SIDED|95.0|-70.04|-20.64||Difference between means, p-value,and CIs are estimated by comparing each Seladelpar level with placebo using ANCOVA model.Treatment group as a factor, baseline GGT assessment as covariate,and percent change from baseline in GGT as response variable.|ANCOVA|||||-20.64|-70.04|0.0007
72455401|NCT02609048|144434105|SUPERIORITY||Difference in LSM|-40.78|STANDARD_ERROR_OF_MEAN|11.033||0.0008|TWO_SIDED|95.0|-63.28|-18.28||Difference between means, p-value,and CIs are estimated by comparing each Seladelpar level with placebo using ANCOVA model.Treatment group as a factor, baseline GGT assessment as covariate,and percent change from baseline in GGT as response variable.|ANCOVA|||||-18.28|-63.28|0.0008
72455402|NCT02609048|144434105|SUPERIORITY||Difference in LSM|-4.56|STANDARD_ERROR_OF_MEAN|12.401||0.7155|TWO_SIDED|95.0|-29.85|20.73||Difference between means, p-value,and CIs are estimated by comparing Seladelpar 200 mg versus 50 mg using ANCOVA model.Treatment group as a factor, baseline GGT assessment as covariate,and percent change from baseline in GGT as response variable.|ANCOVA|||||20.73|-29.85|0.7155
72455403|NCT02609048|144434106|SUPERIORITY||Difference in LSM|-34.27|STANDARD_ERROR_OF_MEAN|11.342||0.005|TWO_SIDED|95.0|-57.4|-11.14||Difference between means,p-value, and CIs are estimated by comparing each Seladelpar level with placebo using ANCOVA model.Treatment group as a factor, baseline 5NT assessment as covariate,and percent change from baseline in 5NT as response variable.|ANCOVA|||||-11.14|-57.40|0.0050
72455404|NCT02609048|144434106|SUPERIORITY||Difference in LSM|-24.84|STANDARD_ERROR_OF_MEAN|10.116||0.0199|TWO_SIDED|95.0|-45.47|-4.21||Difference between means,p-value, and CIs are estimated by comparing each Seladelpar level with placebo using ANCOVA model.Treatment group as a factor, baseline 5NT assessment as covariate,and percent change from baseline in 5NT as response variable.|ANCOVA|||||-4.21|-45.47|0.0199
72455405|NCT02609048|144434106|SUPERIORITY||Difference in LSM|-9.43|STANDARD_ERROR_OF_MEAN|11.442||0.4161|TWO_SIDED|95.0|-32.77|13.9||Difference between means,p-value, and CIs are estimated by comparing Seladelpar 200 mg versus 50 mg using ANCOVA model.Treatment group as a factor, baseline 5NT assessment as covariate,and percent change from baseline in 5NT as response variable.|ANCOVA|||||13.90|-32.77|0.4161
72455406|NCT02609048|144434107|SUPERIORITY||Difference in LSM|6.2|STANDARD_ERROR_OF_MEAN|8.626||0.478|TWO_SIDED|95.0|-11.4|23.79||Difference between means,p-value, and CIs estimated by comparing each Seladelpar level with placebo by ANCOVA model.Treatment group as factor, baseline assessment as covariate, and percent change from baseline in total bilirubin as response variable.|ANCOVA|||||23.79|-11.40|0.4780
72455407|NCT02609048|144434107|SUPERIORITY||Difference in LSM|-12.0|STANDARD_ERROR_OF_MEAN|8.043||0.1459|TWO_SIDED|95.0|-28.4|4.41||Difference between means,p-value, and CIs estimated by comparing each Seladelpar level with placebo by ANCOVA model.Treatment group as factor, baseline assessment as covariate, and percent change from baseline in total bilirubin as response variable.|ANCOVA|||||4.41|-28.40|0.1459
72455408|NCT02609048|144434107|SUPERIORITY||Difference in LSM|18.19|STANDARD_ERROR_OF_MEAN|8.521||0.0407|TWO_SIDED|95.0|0.82|35.57||Difference between means,p-value, and CIs estimated by comparing Seladelpar 200 mg versus 50 mg by ANCOVA model.Treatment group as factor, baseline assessment as covariate, and percent change from baseline in total bilirubin as response variable.|ANCOVA|||||35.57|0.82|0.0407
72455409|NCT02609048|144434108|SUPERIORITY||Difference in LSM|31.47|STANDARD_ERROR_OF_MEAN|13.831||0.03|TWO_SIDED|95.0|3.26|59.67||Difference between means,p-value,and CIs are estimated by each Seladelpar level with placebo using ANCOVA model.Treatment group as factor,baseline assessment as covariate,and percent change from baseline in conjugated bilirubin as response variable.|ANCOVA|||||59.67|3.26|0.0300
72455410|NCT02609048|144434108|SUPERIORITY||Difference in LSM|-8.84|STANDARD_ERROR_OF_MEAN|12.883||0.4979|TWO_SIDED|95.0|-35.11|17.44||Difference between means,p-value,and CIs are estimated by each Seladelpar level with placebo using ANCOVA model.Treatment group as factor,baseline assessment as covariate,and percent change from baseline in conjugated bilirubin as response variable.|ANCOVA|||||17.44|-35.11|0.4979
72455411|NCT02609048|144434108|SUPERIORITY||Difference in LSM|40.3|STANDARD_ERROR_OF_MEAN|13.591||0.0058|TWO_SIDED|95.0|12.58|68.02||Difference between means,p-value,and CIs are estimated for Seladelpar 200 mg versus 50 mg using ANCOVA model.Treatment group as factor,baseline assessment as covariate,and percent change from baseline in conjugated bilirubin as response variable.|ANCOVA|||||68.02|12.58|0.0058
72455412|NCT02609048|144434109|SUPERIORITY||Difference in LSM|-2.97|STANDARD_ERROR_OF_MEAN|8.362||0.7244|TWO_SIDED|95.0|-20.03|14.08||Difference between means,p-value, and CIs are estimated by comparing Seladelpar level with placebo using ANCOVA model.Treatment group as a factor,baseline assessment as covariate, and percent change from baseline as the response variable.|ANCOVA|||||14.08|-20.03|0.7244
72455413|NCT02609048|144434109|SUPERIORITY||Difference in LSM|-14.15|STANDARD_ERROR_OF_MEAN|7.819||0.08|TWO_SIDED|95.0|-30.1|1.8||Difference between means,p-value, and CIs are estimated by comparing Seladelpar level with placebo using ANCOVA model.Treatment group as a factor,baseline assessment as covariate, and percent change from baseline as the response variable.|ANCOVA|||||1.80|-30.10|0.0800
72455414|NCT02609048|144434109|SUPERIORITY||Difference in LSM|11.18|STANDARD_ERROR_OF_MEAN|8.29||0.1874|TWO_SIDED|95.0|-5.73|28.08||Difference between means,p-value, and CIs are estimated by comparing Seladelpar 200 mg versus 50 mg using ANCOVA model.Treatment group as a factor,baseline assessment as covariate, and percent change from baseline as the response variable.|ANCOVA|||||28.08|-5.73|0.1874
72455415|NCT02609048|144434110|SUPERIORITY||Difference in LSM|-45.96|STANDARD_ERROR_OF_MEAN|6.638|<|0.0001|TWO_SIDED|95.0|-59.5|-32.42||Difference between means,p-value,and CIs are estimated comparing each Seladelpar level with placebo using ANCOVA model.Treatment group as factor,baseline bone-specific AP assessment as covariate,and percent change from baseline as response variable.|ANCOVA|||||-32.42|-59.50|<0.0001
72455416|NCT02609048|144434110|SUPERIORITY||Difference in LSM|-34.66|STANDARD_ERROR_OF_MEAN|6.46|<|0.0001|TWO_SIDED|95.0|-47.83|-21.48||Difference between means,p-value,and CIs are estimated comparing each Seladelpar level with placebo using ANCOVA model.Treatment group as factor,baseline bone-specific AP assessment as covariate,and percent change from baseline as response variable.|ANCOVA|||||-21.48|-47.83|<0.0001
72455417|NCT02609048|144434110|SUPERIORITY||Difference in LSM|-11.3|STANDARD_ERROR_OF_MEAN|6.508||0.0924|TWO_SIDED|95.0|-24.58|1.97||Difference between means,p-value,and CIs are estimated comparing Seladelpar 200 mg versus 50 mg using ANCOVA model.Treatment group as factor,baseline bone-specific AP assessment as covariate,and percent change from baseline as response variable.|ANCOVA|||||1.97|-24.58|0.0924
72455418|NCT02609048|144434111|SUPERIORITY||Difference in LSM|-14.15|STANDARD_ERROR_OF_MEAN|12.807||0.2777|TWO_SIDED|95.0|-40.27|11.97||Difference between means,p-value, and CIs are estimated by comparing each Seladelpar level with placebo using ANCOVA model.Treatment group as factor, baseline TG assessment as a covariate, and percent change from baseline in TG as response variable.|ANCOVA|||||11.97|-40.27|0.2777
72455419|NCT02609048|144434111|SUPERIORITY||Difference in LSM|-37.31|STANDARD_ERROR_OF_MEAN|11.946||0.0039|TWO_SIDED|95.0|-61.67|-12.95||Difference between means,p-value, and CIs are estimated by comparing each Seladelpar level with placebo using ANCOVA model.Treatment group as factor, baseline TG assessment as a covariate, and percent change from baseline in TG as response variable.|ANCOVA|||||-12.95|-61.67|0.0039
72620661|NCT02037984|144772324|OTHER|PT1 Percentage Point Difference (V114 - Prevnar 13®)|PT1 Percentage Point Difference|-3.4|||||TWO_SIDED|95.0|-17.3|6.3|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||6.3|-17.3|
72620662|NCT02037984|144772324|OTHER|PT3 Percentage Point Difference (V114 - Prevnar 13®)|PT3 Percentage Point Difference|14.0|||||TWO_SIDED|95.0|-5.5|32.0|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||32.0|-5.5|
72620663|NCT02037984|144772324|OTHER|PT4 Percentage Point Difference (V114 - Prevnar 13®)|PT4 Percentage Point Difference|-7.6|||||TWO_SIDED|95.0|-24.2|5.2|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||5.2|-24.2|
72370397|NCT01708902|144251473|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.135|STANDARD_ERROR_OF_MEAN|1.31||0.0062|TWO_SIDED|95.0|1.383|7.11|||Regression, Logistic|||"Comparison of 'APG: Linagliptin 2.5mg / Metformin 1000mg BID' / 'APG: Linagliptin 5mg QD'.~The logistic regression includes treatment and continuous baseline HbA1c."||7.110|1.383|0.0062
72370398|NCT01708902|144251474|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.12||0.0109|TWO_SIDED|95.0|-0.53|-0.07|||ANCOVA||The adjusted mean difference was calculated as the adjusted mean of 'Main: Linagliptin 2.5mg / Metformin 1000mg BID' minus 'Main: Metformin 1000mg BID'.|"Sensitivity analysis: Mixed Model for repeated measurements~The model includes baseline HbA1c as a linear covariate; visit, treatment and visit by treatment interaction as fixed classification effects and patient as a random effect with unstructured covariance structure to model within-patients errors."||-0.07|-0.53|0.0109
72370399|NCT01708902|144251474|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.04|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-1.27|-0.81|||ANCOVA||The adjusted mean difference was calculated as the adjusted mean of 'Main: Linagliptin 2.5mg / Metformin 1000mg BID' minus 'Main: Linagliptin 5mg QD'.|"Sensitivity analysis: Mixed Model for repeated measurements~The model includes baseline HbA1c as a linear covariate; visit, treatment and visit by treatment interaction as fixed classification effects and patient as a random effect with unstructured covariance structure to model within-patients errors."||-0.81|-1.27|<0.0001
72370400|NCT01708902|144251474|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.47|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-0.7|-0.24|||ANCOVA||The adjusted mean difference was calculated as the adjusted mean of 'Main: Linagliptin 2.5mg / Metformin 500mg BID ' minus 'Main: Metformin 500mg BID' .|"Sensitivity analysis: Mixed Model for repeated measurements~The model includes baseline HbA1c as a linear covariate; visit, treatment and visit by treatment interaction as fixed classification effects and patient as a random effect with unstructured covariance structure to model within-patients errors."||-0.24|-0.70|<0.0001
72370401|NCT01708902|144251474|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.81|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-1.04|-0.58|||ANCOVA||The adjusted mean difference was calculated as the adjusted mean of 'Main: Linagliptin 2.5mg / Metformin 500mg BID' minus 'Main: Linagliptin 5mg QD'.|"Sensitivity analysis: Mixed Model for repeated measurements~The model includes baseline HbA1c as a linear covariate; visit, treatment and visit by treatment interaction as fixed classification effects and patient as a random effect with unstructured covariance structure to model within-patients errors."||-0.58|-1.04|<0.0001
72370402|NCT01708902|144251475|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.25|STANDARD_ERROR_OF_MEAN|0.32||0.0001|TWO_SIDED|95.0|-1.87|-0.63|||ANCOVA||The adjusted mean difference was calculated as the adjusted mean of 'APG: Linagliptin 2.5mg / Metformin 1000mg BID' minus 'APG: Linagliptin 5mg QD'.|"The treatment effect of the 'APG: Linagliptin 2.5mg / Metformin 1000mg BID' was compared with 'APG: Linagliptin 5mg QD'.~The model includes treatment as a fixed effect and baseline HbA1c as a linear covariate."||-0.63|-1.87|0.0001
72370403|NCT01708902|144251476|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.986|STANDARD_ERROR_OF_MEAN|0.387||0.9705|TWO_SIDED|95.0|0.456|2.13|||Regression, Logistic|||"Comparison of 'Main: Linagliptin 2.5mg / Metformin 1000mg BID' / 'Main: Metformin 1000mg BID'.~The logistic regression includes treatment and continuous baseline HbA1c."||2.130|0.456|0.9705
72370404|NCT01708902|144251476|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.093|STANDARD_ERROR_OF_MEAN|1.029||0.0007|TWO_SIDED|95.0|1.612|5.938|||Regression, Logistic|||"Comparison of 'Main: Linagliptin 2.5mg / Metformin 1000mg BID' / 'Main: Linagliptin 5mg QD'.~The logistic regression includes treatment and continuous baseline HbA1c."||5.938|1.612|0.0007
72370405|NCT01708902|144251476|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.19|STANDARD_ERROR_OF_MEAN|1.243||0.0029|TWO_SIDED|95.0|1.486|6.849|||Regression, Logistic|||"Comparison of 'Main: Linagliptin 2.5mg / Metformin 500mg BID' / 'Main: Metformin 500mg BID'.~The logistic regression includes treatment and continuous baseline HbA1c."||6.849|1.486|0.0029
72391956|NCT00299104|144291112|SUPERIORITY_OR_OTHER|||||||0.5939||95.0||||The Closure Principle was used to adjust for multiple comparisons. This was a secondary endpoint in a hierarchical testing structure.|Kruskal-Wallis|||Comparing all three treatment groups.||||0.5939
72391957|NCT00299104|144291112|SUPERIORITY_OR_OTHER|||||||0.5478||95.0||||The Closure Principle was used to adjust for multiple comparisons. This was a secondary endpoint in a hierarchical testing structure.|Van-Elteren|||Rituximab 2 x 0.5 g + Methotrexate arm versus Placebo + Methotrexate, stratified for region and baseline RF status||||0.5478
72391958|NCT00299104|144291112|SUPERIORITY_OR_OTHER|||||||0.3096||95.0||||The Closure Principle was used to adjust for multiple comparisons. This was a secondary endpoint in a hierarchical testing structure.|Van-Elteren|||Rituximab 2 x 1.0 g + Methotrexate arm versus Placebo + Methotrexate, stratified for region and baseline RF status||||0.3096
72391959|NCT00299104|144291117|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||This was a secondary endpoint in a hierarchical testing structure.|Cochran-Mantel-Haenszel|||Rituximab 2 x 0.5 g + Methotrexate arm versus Placebo + Methotrexate, stratified for region and baseline RF status||||<0.0001
72391960|NCT00299104|144291117|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||This was a secondary endpoint in a hierarchical testing structure.|Cochran-Mantel-Haenszel|||Rituximab 2 x 1.0 g + Methotrexate arm versus Placebo + Methotrexate, stratified for region and baseline RF status||||<0.0001
72391961|NCT00299104|144291127|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Secondary endpoint in hierarchical testing structure.|ANOVA|||Rituximab (0.5 g x 2) + Methotrexate versus Placebo + Methotrexate stratified for region and RF status.||||<0.0001
72391962|NCT00299104|144291127|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Secondary endpoint in hierarchical testing structure.|ANOVA|||Rituximab (1.0 g x 2) + Methotrexate versus Placebo + Methotrexate, stratified for region and baseline RF status.||||<0.0001
72391963|NCT00299104|144291133|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||This was a secondary endpoint in a hierarchical testing structure.|Van-Elteren|||Week 104: Rituximab 2 x 0.5 g + Methotrexate arm versus Placebo + Methotrexate, stratified for region and baseline rheumatoid factor (RF) status.||||<0.0001
72391964|NCT00299104|144291137|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Secondary endpoint in hierarchical testing structure.|ANOVA|||Rituximab (0.5 g x 2) + Methotrexate versus Placebo + Methotrexate, stratified for region and baseline RF status.||||<0.0001
72455420|NCT02609048|144434111|SUPERIORITY||Difference in LSM|23.16|STANDARD_ERROR_OF_MEAN|12.498||0.0734|TWO_SIDED|95.0|-2.33|48.65||Difference between means,p-value, and CIs are estimated by comparing Seladelpar 200 mg versus 50 mg using ANCOVA model.Treatment group as factor, baseline TG assessment as a covariate, and percent change from baseline in TG as response variable.|ANCOVA|||||48.65|-2.33|0.0734
72391965|NCT00299104|144291137|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Secondary endpoint in hierarchical testing structure.|ANOVA|||Rituximab (1.0 g x 2) + Methotrexate versus Placebo + Methotrexate, stratified for region and baseline RF status.||||<0.0001
72391966|NCT02197247|144291144|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|No effect on the PK of AZD9291 after co-administration of rifampicin was concluded if the lower bound of the 90% confidence intervals (CIs) for the ratios (Period 2 versus Period 1) of AZD9291 AUCtau and Css,max were both above 50%. The experiment-wide power for the ratios being above 50% was 90% (95% power for each parameter).|Geometric least-squares (LS) mean ratio|27.16|||||TWO_SIDED|90.0|24.36|30.29|||||AZD9291+rifampicin / AZD9291 alone (Period 2 versus Period 1).|Natural log-transformed Css,max values were compared between periods using a mixed effects analysis of variance (ANOVA) with period as fixed effect and patient as random effect. It was assumed the within-patient coefficient of variation for AZD9291 in both area under the plasma concentration-time curve during the dosing interval (AUCtau) and Cmax was 34%. A 33% decrease in exposure for AZD9291 when given with rifampicin was also assumed.||30.29|24.36|
72391967|NCT02197247|144291145|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|No effect on the PK of AZD9291 after co-administration of rifampicin was concluded if the lower bound of the 90% CIs for the ratios (Period 2 versus Period 1) of AZD9291 AUCtau and Css,max were both above 50%. The experiment-wide power for the ratios being above 50% was 90% (95% power for each parameter).|Geometric LS Mean Ratio|21.55|||||TWO_SIDED|90.0|19.5|23.83|||||AZD9291+rifampicin / AZD9291 alone (Period 2 versus Period 1).|Natural log-transformed AUCtau values were compared between periods using a mixed effects ANOVA with period as fixed effect and patient as random effect. It was assumed the within-patient coefficient of variation for AZD9291 in both AUCtau and Cmax was 34%. A 33% decrease in exposure for AZD9291 when given with rifampicin was also assumed.||23.83|19.50|
72391968|NCT02197247|144291146|SUPERIORITY_OR_OTHER_LEGACY||Geometric LS Mean Ratio|95.53|||||TWO_SIDED|90.0|85.27|107.03|||||AZD9291 alone / AZD9291 alone (Period 3 versus Period 1). No pre-specified margins for equivalence test for AZD9291 alone in separate periods, but analysed for consistency with AZD9291+rifampicin / AZD9291 alone analysis (primary outcome measure).|Natural log-transformed Css,max values were compared between periods using a mixed effects ANOVA with period as a fixed effect and patient as a random effect.||107.03|85.27|
72391969|NCT02197247|144291147|SUPERIORITY_OR_OTHER_LEGACY||Geometric LS Mean Ratio|21.72|||||TWO_SIDED|90.0|19.08|24.72|||||AZD9291+rifampicin / AZD9291 alone (Period 2 versus Period 1). No pre-specified margins for equivalence test for metabolites, but analysed for consistency with AZD9291 analysis.|For AZ5104 (metabolite), natural log-transformed Css,max values were compared between periods using a mixed effects ANOVA with period as a fixed effect and patient as a random effect.||24.72|19.08|
72391970|NCT02197247|144291147|SUPERIORITY_OR_OTHER_LEGACY||Geometric LS Mean Ratio|88.31|||||TWO_SIDED|90.0|77.17|101.07|||||AZD9291 alone / AZD9291 alone (Period 3 versus Period 1). No pre-specified margins for equivalence test for metabolites, but analysed for consistency with AZD9291 analysis.|For AZ5104 (metabolite), natural log-transformed Css,max values were compared between periods using a mixed effects ANOVA with period as a fixed effect and patient as a random effect.||101.07|77.17|
72455421|NCT02609048|144434112|SUPERIORITY||Difference in LSM|-16.12|STANDARD_ERROR_OF_MEAN|4.433||0.001|TWO_SIDED|95.0|-25.16|-7.07||Difference between means,p-value,and CIs are estimated by comparing each Seladelpar level with placebo using ANCOVA model.Treatment group as factor, baseline TC assessment as covariate,and percent change from baseline in TC as the response variable.|ANCOVA|||||-7.07|-25.16|0.0010
72455422|NCT02609048|144434112|SUPERIORITY||Difference in LSM|-8.13|STANDARD_ERROR_OF_MEAN|3.992||0.0504|TWO_SIDED|95.0|-16.27|0.02||Difference between means,p-value,and CIs are estimated by comparing each Seladelpar level with placebo using ANCOVA model.Treatment group as factor, baseline TC assessment as covariate,and percent change from baseline in TC as the response variable.|ANCOVA|||||0.02|-16.27|0.0504
72620664|NCT02037984|144772324|OTHER|PT5 Percentage Point Difference (V114 - Prevnar 13®)|PT5 Percentage Point Difference|-3.4|||||TWO_SIDED|95.0|-17.3|6.3|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||6.3|-17.3|
72455423|NCT02609048|144434112|SUPERIORITY||Difference in LSM|-7.99|STANDARD_ERROR_OF_MEAN|4.317||0.0738|TWO_SIDED|95.0|-16.8|0.81||Difference between means,p-value,and CIs are estimated by comparing Seladelpar 200 mg versus 50 mg using ANCOVA model.Treatment group as factor, baseline TC assessment as covariate,and percent change from baseline in TC as the response variable.|ANCOVA|||||0.81|-16.80|0.0738
72455424|NCT02609048|144434113|SUPERIORITY||Difference in LSM|-17.39|STANDARD_ERROR_OF_MEAN|5.848||0.0057|TWO_SIDED|95.0|-29.32|-5.46||Difference between means,p-value,and CIs estimated by comparing each Seladelpar level with placebo using ANCOVA model.Treatment group as factor,baseline HDL-C assessment as covariate,and percent change from baseline in HDL-C as response variable.|ANCOVA|||||-5.46|-29.32|0.0057
72455425|NCT02609048|144434113|SUPERIORITY||Difference in LSM|-0.89|STANDARD_ERROR_OF_MEAN|5.378||0.8703|TWO_SIDED|95.0|-11.85|10.08||Difference between means,p-value,and CIs estimated by comparing each Seladelpar level with placebo using ANCOVA model.Treatment group as factor,baseline HDL-C assessment as covariate,and percent change from baseline in HDL-C as response variable.|ANCOVA|||||10.08|-11.85|0.8703
72455426|NCT02609048|144434113|SUPERIORITY||Difference in LSM|-16.51|STANDARD_ERROR_OF_MEAN|5.781||0.0076|TWO_SIDED|95.0|-28.3|-4.71||Difference between means,p-value,and CIs estimated by comparing Seladelpar 200 mg versus 50 mg using ANCOVA model.Treatment group as factor,baseline HDL-C assessment as covariate,and percent change from baseline in HDL-C as response variable.|ANCOVA|||||-4.71|-28.30|0.0076
72455427|NCT02609048|144434114|SUPERIORITY||Difference in LSM|-14.85|STANDARD_ERROR_OF_MEAN|5.981||0.0186|TWO_SIDED|95.0|-27.05|-2.66||Difference between means,p-value, and CIs estimated by comparing each Seladelpar level with placebo using ANCOVA model.Treatment group as factor,baseline LDL-C assessment as covariate,and percent change from baseline in LDL-C as response variable.|ANCOVA|||||-2.66|-27.05|0.0186
72455428|NCT02609048|144434114|SUPERIORITY||Difference in LSM|-10.06|STANDARD_ERROR_OF_MEAN|5.448||0.0745|TWO_SIDED|95.0|-21.17|1.06||Difference between means,p-value, and CIs estimated by comparing each Seladelpar level with placebo using ANCOVA model.Treatment group as factor,baseline LDL-C assessment as covariate,and percent change from baseline in LDL-C as response variable.|ANCOVA|||||1.06|-21.17|0.0745
72455429|NCT02609048|144434114|SUPERIORITY||Difference in LSM|-4.8|STANDARD_ERROR_OF_MEAN|5.785||0.4131|TWO_SIDED|95.0|-16.6|7.0||Difference between means,p-value, and CIs estimated by comparing Seladelpar 200 mg versus 50 mg using ANCOVA model.Treatment group as factor,baseline LDL-C assessment as covariate,and percent change from baseline in LDL-C as response variable.|ANCOVA|||||7.00|-16.60|0.4131
72455430|NCT02609048|144434115|SUPERIORITY|||||||0.4667||||||Fisher's exact test between each Seladelpar level compared with placebo was used to obtain the p-value.|Fisher Exact|||||||0.4667
72455431|NCT02609048|144434115|SUPERIORITY|||||||0.4667||||||Fisher's exact test between Seladelpar 200 mg versus 50 mg was used to obtain the p-value.|Fisher Exact|||||||0.4667
72455432|NCT02609048|144434116|SUPERIORITY|||||||0.0824||||||Fisher's exact test between each Seladelpar level compared with placebo was used to obtain the p-value.|Fisher Exact|||||||0.0824
72455433|NCT02609048|144434116|SUPERIORITY|||||||0.0537||||||Fisher's exact test between each Seladelpar level compared with placebo was used to obtain the p-value.|Fisher Exact|||||||0.0537
72455434|NCT02609048|144434116|SUPERIORITY|||||||1||||||Fisher's exact test between Seladelpar 200 mg versus 50 mg was used to obtain the p-value.|Fisher Exact|||||||1.0000
72455435|NCT02609048|144434117|SUPERIORITY|||||||0.0101||||||Fisher's exact test between each Seladelpar level compared with placebo was used to obtain the p-value.|Fisher Exact|||||||0.0101
72455436|NCT02609048|144434117|SUPERIORITY|||||||0.0198||||||Fisher's exact test between each Seladelpar level compared with placebo was used to obtain the p-value.|Fisher Exact|||||||0.0198
72455437|NCT02609048|144434117|SUPERIORITY|||||||0.5165||||||Fisher's exact test between Seladelpar 200 mg versus 50 mg was used to obtain the p-value.|Fisher Exact|||||||0.5165
72455438|NCT02609048|144434118|SUPERIORITY|||||||0.0101||||||Fisher's exact test between each Seladelpar level compared with placebo was used to obtain the p-value.|Fisher Exact|||||||0.0101
72455439|NCT02609048|144434118|SUPERIORITY|||||||0.0055||||||Fisher's exact test between each Seladelpar level compared with placebo was used to obtain the p-value.|Fisher Exact|||||||0.0055
72455440|NCT02609048|144434118|SUPERIORITY|||||||1||||||Fisher's exact test between Seladelpar 200 mg versus 50 mg was used to obtain the p-value.|Fisher Exact|||||||1.0000
72455441|NCT02609048|144434120|SUPERIORITY||Difference in LSM|-1.1|STANDARD_ERROR_OF_MEAN|1.82||0.5379|TWO_SIDED|95.0|-4.8|2.6||Difference between means,p-value, and CIs are estimated by comparing each Seladelpar level with placebo using ANCOVA model.Treatment group as factor, baseline score as covariate, and change from baseline score as the response variable.|ANCOVA|||||2.6|-4.8|0.5379
72455442|NCT02609048|144434120|SUPERIORITY||Difference in LSM|0.2|STANDARD_ERROR_OF_MEAN|1.7||0.8949|TWO_SIDED|95.0|-3.3|3.7||Difference between means,p-value, and CIs are estimated by comparing each Seladelpar level with placebo using ANCOVA model.Treatment group as factor, baseline score as covariate, and change from baseline score as the response variable.|ANCOVA|||||3.7|-3.3|0.8949
72455443|NCT02609048|144434120|SUPERIORITY||Difference in LSM|-1.4|STANDARD_ERROR_OF_MEAN|1.75||0.4431|TWO_SIDED|95.0|-4.9|2.2||Difference between means,p-value, and CIs are estimated by comparing Seladelpar 200 mg versus 50 mg using ANCOVA model.Treatment group as factor, baseline score as covariate, and change from baseline score as the response variable.|ANCOVA|||||2.2|-4.9|0.4431
72455444|NCT02609048|144434121|SUPERIORITY||Difference in LSM|-7.4|STANDARD_ERROR_OF_MEAN|10.07||0.4674|TWO_SIDED|95.0|-28.0|13.2||Difference between means,p-value, and CIs are estimated by comparing each Seladelpar level with placebo using ANCOVA model. Treatment group as factor, baseline score as a covariate, and change from baseline score as the response variable.|ANCOVA|||||13.2|-28.0|0.4674
72620665|NCT02037984|144772324|OTHER|PT6A Percentage Point Difference (V114 - Prevnar 13®)|PT6A Percentage Point Difference|0.0|||||TWO_SIDED|95.0|-11.9|9.5|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||9.5|-11.9|
72620666|NCT02037984|144772324|OTHER|PT6B Percentage Point Difference (V114 - Prevnar 13®)|PT6B Percentage Point Difference|0.0|||||TWO_SIDED|95.0|-11.9|9.5|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||9.5|-11.9|
72500046|NCT00190775|144530127|SUPERIORITY_OR_OTHER|||||||0.722||95.0||||P-Value for Total ADHD Symptoms Score.|ANCOVA|Model included visit by therapy, pooled investigator, child with ADHD, and baseline.||||||0.722
72500047|NCT00190775|144530127|SUPERIORITY_OR_OTHER|||||||0.011||95.0||||P-Value for Total ADHD Symptoms Score.|ANCOVA|Model included visit by therapy, pooled investigator, child with ADHD, and baseline.||||||0.011
72500048|NCT00190775|144530127|SUPERIORITY_OR_OTHER|||||||0.005||95.0||||P-Value for Total ADHD Symptoms Score.|ANCOVA|Model included visit by therapy, pooled investigator, child with ADHD, and baseline.||||||0.005
72500049|NCT00190775|144530127|SUPERIORITY_OR_OTHER|||||||0.779||95.0||||P-Value for Hyper/Impulsive Scale.|ANCOVA|Model included visit by therapy, pooled investigator, child with ADHD, and baseline.||||||0.779
72500050|NCT00190775|144530127|SUPERIORITY_OR_OTHER|||||||0.004||95.0||||P-Value for Hyper/Impulsive Subscale.|ANCOVA|Model included visit by therapy, pooled investigator, child with ADHD, and baseline.||||||0.004
72562844|NCT00317642|144657431|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.11||||0.5071|TWO_SIDED|95.0|0.81|1.53|||Log Rank|||||1.53|0.81|0.5071
72562845|NCT00317642|144657431|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.83||||0.2906|TWO_SIDED|95.0|0.59|1.17|||Log Rank|||||1.17|0.59|0.2906
72562846|NCT00317642|144657432|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.63|||<|0.0001|TWO_SIDED|95.0|0.49|0.79|||Log Rank|||Full Analysis Set (FAS) population.||0.79|0.49|<.0001
72562847|NCT00317642|144657432|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.73||||0.0486|TWO_SIDED|95.0|0.53|1.01|||Log Rank|||||1.01|0.53|0.0486
72370406|NCT01708902|144251476|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.871|STANDARD_ERROR_OF_MEAN|1.846|<|0.0001|TWO_SIDED|95.0|2.318|10.238|||Regression, Logistic|||"Comparison of 'Main: Linagliptin 2.5mg / Metformin 500mg BID' / 'Main: Linagliptin 5mg QD'.~The logistic regression includes treatment and continuous baseline HbA1c."||10.238|2.318|<0.0001
72370407|NCT01708902|144251477|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.865|STANDARD_ERROR_OF_MEAN|1.015||0.2523|TWO_SIDED|95.0|0.642|5.42|||Regression, Logistic|||"Comparison of 'APG: Linagliptin 2.5mg / Metformin 1000mg BID' / 'APG: Linagliptin 5mg QD'.~The logistic regression includes treatment and continuous baseline HbA1c."||5.420|0.642|0.2523
72455445|NCT02609048|144434121|SUPERIORITY||Difference in LSM|-9.0|STANDARD_ERROR_OF_MEAN|8.99||0.3236|TWO_SIDED|95.0|-27.4|9.4||Difference between means,p-value, and CIs are estimated by comparing each Seladelpar level with placebo using ANCOVA model. Treatment group as factor, baseline score as a covariate, and change from baseline score as the response variable.|ANCOVA|||||9.4|-27.4|0.3236
72455446|NCT02609048|144434121|SUPERIORITY||Difference in LSM|1.6|STANDARD_ERROR_OF_MEAN|9.92||0.8723|TWO_SIDED|95.0|-18.7|21.9||Difference between means,p-value, and CIs are estimated by comparing Seladelpar 200 mg versus 50 mg using ANCOVA model. Treatment group as factor, baseline score as a covariate, and change from baseline score as the response variable.|ANCOVA|||||21.9|-18.7|0.8723
72455447|NCT02609048|144434122|SUPERIORITY||Difference in LSM|3.4|STANDARD_ERROR_OF_MEAN|1.25||0.0115|TWO_SIDED|95.0|0.8|6.0||Difference between means,p-value,and CIs are estimated comparing each Seladelpar level with placebo using ANCOVA model.Treatment group as factor,baseline PBC 40 QoL domain score as covariate, change from baseline in domain score as response variable.|ANCOVA|||Cognitive Domain Score||6.0|0.8|0.0115
72455448|NCT02609048|144434122|SUPERIORITY||Difference in LSM|1.8|STANDARD_ERROR_OF_MEAN|1.1||0.1256|TWO_SIDED|95.0|-0.5|4.0||Difference between means,p-value,and CIs are estimated comparing each Seladelpar level with placebo using ANCOVA model.Treatment group as factor,baseline PBC 40 QoL domain score as covariate, change from baseline in domain score as response variable.|ANCOVA|||Cognitive Domain Score||4.0|-0.5|0.1256
72500051|NCT00190775|144530127|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||P-Value for Hyper/Impulsive Subscale.|ANCOVA|Model included visit by therapy, pooled investigator, child with ADHD, and baseline.||||||0.002
72500052|NCT00190775|144530127|SUPERIORITY_OR_OTHER|||||||0.716||95.0||||P-Value for Inattention Subscale.|ANCOVA|Model included visit by therapy, pooled investigator, child with ADHD, and baseline.||||||0.716
72500053|NCT00190775|144530127|SUPERIORITY_OR_OTHER|||||||0.071||95.0||||P-Value for Inattention Subscale.|ANCOVA|Model included visit by therapy, pooled investigator, child with ADHD, and baseline.||||||0.071
72500054|NCT00190775|144530127|SUPERIORITY_OR_OTHER|||||||0.034||95.0||||P-Value for Inattention Subscale.|ANCOVA|Model included visit by therapy, pooled investigator, child with ADHD, and baseline.||||||0.034
72500055|NCT00190775|144530127|SUPERIORITY_OR_OTHER|||||||0.938||95.0||||P-Value for ADHD Index Subscale.|ANCOVA|Model included visit by therapy, pooled investigator, child with ADHD, and baseline.||||||0.938
72562848|NCT00317642|144657432|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.52||||0.0002|TWO_SIDED|95.0|0.37|0.74|||Log Rank|||||0.74|0.37|0.0002
72562849|NCT00317642|144657433|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Cochran-Mantel-Haenszel|||Full Analysis Set (FAS) population||||<0.0001
72562850|NCT00317642|144657433|SUPERIORITY_OR_OTHER|||||||0.0088||95.0|||||Fisher Exact|||Participants stratified by randomization strata CR1 \<6 months.||||0.0088
72562851|NCT00317642|144657433|SUPERIORITY_OR_OTHER|||||||0.0017||95.0|||||Fisher Exact|||Participants stratified by randomization strata CR1 \>=6 months||||0.0017
72562852|NCT00317642|144657434|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Cochran-Mantel-Haenszel|||||||<0.0001
72562853|NCT00317642|144657434|SUPERIORITY_OR_OTHER|||||||0.0506||95.0|||||Fisher Exact|||||||0.0506
72562854|NCT00317642|144657434|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Fisher Exact|||||||<0.0001
72562855|NCT01239472|144657452|SUPERIORITY||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
72562856|NCT01239472|144657453|SUPERIORITY||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
72562857|NCT01049412|144657467|SUPERIORITY_OR_OTHER||Least Squares Mean Difference (Final)|-0.55|STANDARD_ERROR_OF_MEAN|0.16|<|0.001|TWO_SIDED|90.0|-0.81|-0.29||The statistical significance level is 0.10.|Mixed Models Analysis|||||-0.29|-0.81|<0.001
72562858|NCT01049412|144657468|SUPERIORITY_OR_OTHER||Least Squares Mean Difference (Final)|-0.56|STANDARD_ERROR_OF_MEAN|0.16|<|0.001|TWO_SIDED|90.0|-0.83|-0.29||The statistical significance level is 0.10.|Mixed Models Analysis|||||-0.29|-0.83|<0.001
72562859|NCT01049412|144657469|SUPERIORITY_OR_OTHER||Least Squares Mean Difference (Final)|-0.11|STANDARD_ERROR_OF_MEAN|0.1||0.242|TWO_SIDED|90.0|-0.28|0.05||The statistical significance level is 0.10.|Mixed Models Analysis|||||0.05|-0.28|0.242
72562860|NCT01049412|144657470|SUPERIORITY_OR_OTHER|||||||0.276||95.0||||"The statistical significance level is 0.10.~P-value is for HbA1c \<7.0%."|Fisher Exact|||||||0.276
72562861|NCT01049412|144657470|SUPERIORITY_OR_OTHER|||||||0.119||95.0||||"The statistical significance level is 0.10.~P-value is for HbA1c ≤6.5%."|Fisher Exact|||||||0.119
72455449|NCT02609048|144434122|SUPERIORITY||Difference in LSM|1.7|STANDARD_ERROR_OF_MEAN|1.22||0.1842|TWO_SIDED|95.0|-0.9|4.2||Difference between means,p-value,and CIs are estimated comparing Seladelpar 200 mg versus 50 mg using ANCOVA model.Treatment group as factor,baseline PBC 40 QoL domain score as covariate, change from baseline in domain score as response variable.|ANCOVA|||Cognitive Domain Score||4.2|-0.9|0.1842
72455450|NCT02609048|144434122|SUPERIORITY||Difference in LSM|3.7|STANDARD_ERROR_OF_MEAN|1.7||0.042|TWO_SIDED|95.0|0.1|7.2||Difference between means,p-value,and CIs are estimated comparing each Seladelpar level with placebo using ANCOVA model.Treatment group as factor,baseline PBC 40 QoL domain score as covariate, change from baseline in domain score as response variable.|ANCOVA|||Social Domain Score||7.2|0.1|0.0420
72455451|NCT02609048|144434122|SUPERIORITY||Difference in LSM|0.7|STANDARD_ERROR_OF_MEAN|1.54||0.6384|TWO_SIDED|95.0|-2.4|3.9||Difference between means,p-value,and CIs are estimated comparing each Seladelpar level with placebo using ANCOVA model.Treatment group as factor,baseline PBC 40 QoL domain score as covariate, change from baseline in domain score as response variable.|ANCOVA|||Social Domain Score||3.9|-2.4|0.6384
72455452|NCT02609048|144434122|SUPERIORITY||Difference in LSM|2.9|STANDARD_ERROR_OF_MEAN|1.73||0.1035|TWO_SIDED|95.0|-0.6|6.5||Difference between means,p-value,and CIs are estimated comparing Seladelpar 200 mg versus 50 mg using ANCOVA model.Treatment group as factor,baseline PBC 40 QoL domain score as covariate, change from baseline in domain score as response variable.|ANCOVA|||Social Domain Score||6.5|-0.6|0.1035
72455453|NCT02609048|144434122|SUPERIORITY||Difference in LSM|0.4|STANDARD_ERROR_OF_MEAN|0.96||0.6967|TWO_SIDED|95.0|-1.6|2.4||Difference between means,p-value,and CIs are estimated comparing each Seladelpar level with placebo using ANCOVA model.Treatment group as factor,baseline PBC 40 QoL domain score as covariate, change from baseline in domain score as response variable.|ANCOVA|||Emotional Function Domain Score||2.4|-1.6|0.6967
72455454|NCT02609048|144434122|SUPERIORITY||Difference in LSM|0.4|STANDARD_ERROR_OF_MEAN|0.85||0.6164|TWO_SIDED|95.0|-1.3|2.2||Difference between means,p-value,and CIs are estimated comparing each Seladelpar level with placebo using ANCOVA model.Treatment group as factor,baseline PBC 40 QoL domain score as covariate, change from baseline in domain score as response variable.|ANCOVA|||Emotional Function Domain Score||2.2|-1.3|0.6164
72455455|NCT02609048|144434122|SUPERIORITY||Difference in LSM|-0.1|STANDARD_ERROR_OF_MEAN|0.93||0.9548|TWO_SIDED|95.0|-2.0|1.9|||ANCOVA|||Emotional Function Domain Score||1.9|-2.0|0.9548
72455456|NCT02609048|144434122|SUPERIORITY||Difference in LSM|-0.2|STANDARD_ERROR_OF_MEAN|1.04||0.8286|TWO_SIDED|95.0|-2.4|1.9||Difference between means,p-value,and CIs are estimated comparing each Seladelpar level with placebo using ANCOVA model.Treatment group as factor,baseline PBC 40 QoL domain score as covariate, change from baseline in domain score as response variable.|ANCOVA|||Itch Domain Score||1.9|-2.4|0.8286
72455457|NCT02609048|144434122|SUPERIORITY||Difference in LSM|4.2|STANDARD_ERROR_OF_MEAN|1.74||0.0226|TWO_SIDED|95.0|0.6|7.8||Difference between means,p-value,and CIs are estimated comparing each Seladelpar level with placebo using ANCOVA model.Treatment group as factor,baseline PBC 40 QoL domain score as covariate, change from baseline in domain score as response variable.|ANCOVA|||Fatigue Domain Score||7.8|0.6|0.0226
72455458|NCT02609048|144434122|SUPERIORITY||Difference in LSM|-2.6|STANDARD_ERROR_OF_MEAN|1.92||0.1861|TWO_SIDED|95.0|-6.6|1.4||Difference between means,p-value,and CIs are estimated comparing Seladelpar 200 mg versus 50 mg using ANCOVA model.Treatment group as factor,baseline PBC 40 QoL domain score as covariate, change from baseline in domain score as response variable.|ANCOVA|||Fatigue Domain Score||1.4|-6.6|0.1861
72455459|NCT02609048|144434122|SUPERIORITY||Difference in LSM|1.6|STANDARD_ERROR_OF_MEAN|1.96||0.4159|TWO_SIDED|95.0|-2.4|5.7||Difference between means,p-value,and CIs are estimated comparing each Seladelpar level with placebo using ANCOVA model.Treatment group as factor,baseline PBC 40 QoL domain score as covariate, change from baseline in domain score as response variable.|ANCOVA|||Fatigue Domain Score||5.7|-2.4|0.4159
72455460|NCT02609048|144434122|SUPERIORITY||Difference in LSM|0.7|STANDARD_ERROR_OF_MEAN|0.93||0.4848|TWO_SIDED|95.0|-1.3|2.6||Difference between means,p-value,and CIs are estimated comparing each Seladelpar level with placebo using ANCOVA model.Treatment group as factor,baseline PBC 40 QoL domain score as covariate, change from baseline in domain score as response variable.|ANCOVA|||Itch Domain Score||2.6|-1.3|0.4848
72455461|NCT02609048|144434122|SUPERIORITY||Difference in LSM|-0.9|STANDARD_ERROR_OF_MEAN|1.05||0.4048|TWO_SIDED|95.0|-3.1|1.3||Difference between means,p-value,and CIs are estimated comparing Seladelpar 200 mg versus 50 mg using ANCOVA model.Treatment group as factor,baseline PBC 40 QoL domain score as covariate, change from baseline in domain score as response variable.|ANCOVA|||Itch Domain Score||1.3|-3.1|0.4048
72562862|NCT01049412|144657472|SUPERIORITY_OR_OTHER||Least Squares Mean Difference (Final)|0.3|STANDARD_ERROR_OF_MEAN|0.35||0.392|TWO_SIDED|90.0|-0.28|0.88||"The statistical significance level is 0.10.~P-value is for 0300 hour BG."|Mixed Models Analysis|||||0.88|-0.28|0.392
72562863|NCT01049412|144657472|SUPERIORITY_OR_OTHER||Least Squares Mean Difference (Final)|-0.24|STANDARD_ERROR_OF_MEAN|0.33||0.464|TWO_SIDED|90.0|-0.79|0.3||"The statistical significance level is 0.10.~P-value is for morning FBG."|Mixed Models Analysis|||||0.30|-0.79|0.464
72455462|NCT02609048|144434122|SUPERIORITY||Difference in LSM|2.6|STANDARD_ERROR_OF_MEAN|1.0||0.0141|TWO_SIDED|95.0|0.6|4.7||Difference between means,p-value,and CIs are estimated comparing each Seladelpar level with placebo using ANCOVA model.Treatment group as factor,baseline PBC 40 QoL domain score as covariate, change from baseline in domain score as response variable.|ANCOVA|||Symptoms Domain Score||4.7|0.6|0.0141
72370408|NCT01708902|144251478|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.37|STANDARD_ERROR_OF_MEAN|3.23||0.0971|TWO_SIDED|95.0|-11.72|0.98|||ANCOVA||The adjusted mean difference was calculated as the adjusted mean of 'Main: Linagliptin 2.5mg / Metformin 1000mg BID' minus 'Main: Metformin 1000mg BID'.|The model includes continuous baseline HbA1c, continuous baseline FPG and treatment group.||0.98|-11.72|0.0971
72500056|NCT00190775|144530127|SUPERIORITY_OR_OTHER|||||||0.004||95.0||||P-Value for ADHD Index Subscale.|ANCOVA|Model included visit by therapy, pooled investigator, child with ADHD, and baseline.||||||0.004
72562864|NCT01049412|144657472|SUPERIORITY_OR_OTHER||Least Squares Mean Difference (Final)|-0.48|STANDARD_ERROR_OF_MEAN|0.33||0.151|TWO_SIDED|90.0|-1.04|0.07||"The statistical significance level is 0.10.~P-value is for morning 2-hr postprandial BG."|Mixed Models Analysis|||||0.07|-1.04|0.151
72620667|NCT02037984|144772324|OTHER|PT7F Percentage Point Difference (V114 - Prevnar 13®)|PT7F Percentage Point Difference|0.0|||||TWO_SIDED|95.0|-11.9|9.5|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||9.5|-11.9|
72391971|NCT02197247|144291148|SUPERIORITY_OR_OTHER_LEGACY||Geometric LS Mean Ratio|139.32|||||TWO_SIDED|90.0|127.74|151.96|||||AZD9291+rifampicin / AZD9291 alone (Period 2 versus Period 1). No pre-specified margins for equivalence test for metabolites, but analysed for consistency with AZD9291 analysis.|For AZ7550 (metabolite), natural log-transformed Css,max values were compared between periods using a mixed effects ANOVA with period as a fixed effect and patient as a random effect.||151.96|127.74|
72391972|NCT02197247|144291148|SUPERIORITY_OR_OTHER_LEGACY||Geometric LS Mean Ratio|100.75|||||TWO_SIDED|90.0|92.04|110.29|||||AZD9291 alone / AZD9291 alone (Period 3 versus Period 1). No pre-specified margins for equivalence test for metabolites, but analysed for consistency with AZD9291 analysis.|For AZ7550 (metabolite), natural log-transformed Css,max values were compared between periods using a mixed effects ANOVA with period as a fixed effect and patient as a random effect.||110.29|92.04|
72391973|NCT02197247|144291150|SUPERIORITY_OR_OTHER_LEGACY||Geometric LS Mean Ratio|95.89|||||TWO_SIDED|90.0|86.37|106.45|||||AZD9291 alone / AZD9291 alone (Period 3 versus Period 1). No pre-specified margins for equivalence test for AZD9291 alone in separate periods, but analysed for consistency with AZD9291+rifampicin / AZD9291 alone analysis (primary outcome measure).|Natural log-transformed AUCtau values were compared between periods using a mixed effects ANOVA with period as a fixed effect and patient as a random effect.||106.45|86.37|
72391974|NCT02197247|144291151|SUPERIORITY_OR_OTHER_LEGACY||Geometric LS Mean Ratio|18.76|||||TWO_SIDED|90.0|16.61|21.19|||||AZD9291+rifampicin / AZD9291 alone (Period 2 versus Period 1). No pre-specified margins for equivalence test for metabolites, but analysed for consistency with AZD9291 analysis.|For AZ5104 (metabolite), natural log-transformed AUCtau values were compared between periods using a mixed effects ANOVA with period as a fixed effect and patient as a random effect.||21.19|16.61|
72391975|NCT02197247|144291151|SUPERIORITY_OR_OTHER_LEGACY||Geometric LS Mean Ratio|90.08|||||TWO_SIDED|90.0|79.34|102.27|||||AZD9291 alone / AZD9291 alone (Period 3 versus Period 1). No pre-specified margins for equivalence test for metabolites, but analysed for consistency with AZD9291 analysis.|For AZ5104 (metabolite), natural log-transformed AUCtau values were compared between periods using a mixed effects ANOVA with period as a fixed effect and patient as a random effect.||102.27|79.34|
72391976|NCT02197247|144291152|SUPERIORITY_OR_OTHER_LEGACY||Geometric LS Mean Ratio|129.81|||||TWO_SIDED|90.0|119.14|141.44|||||AZD9291+rifampicin / AZD9291 alone (Period 2 versus Period 1). No pre-specified margins for equivalence test for metabolites, but analysed for consistency with AZD9291 analysis.|For AZ7550 (metabolite), natural log-transformed AUCtau values were compared between periods using a mixed effects ANOVA with period as a fixed effect and patient as a random effect.||141.44|119.14|
72391977|NCT02197247|144291152|SUPERIORITY_OR_OTHER_LEGACY||Geometric LS Mean Ratio|100.76|||||TWO_SIDED|90.0|92.15|110.19|||||AZD9291 alone / AZD9291 alone (Period 3 versus Period 1). No pre-specified margins for equivalence test for metabolites, but analysed for consistency with AZD9291 analysis.|For AZ7550 (metabolite), natural log-transformed AUCtau values were compared between periods using a mixed effects ANOVA with period as a fixed effect and patient as a random effect.||110.19|92.15|
72391978|NCT00370032|144291179|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.1||||0.131||95.0|-18.4|2.157|||paired t-test Hommel-Simes|||||2.157|-18.4|0.131
72391979|NCT00370032|144291179|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.11||||0.131||95.0|-21.2|2.997|||paired t-test Hommel-Simes|||||2.997|-21.2|0.131
72455463|NCT02609048|144434122|SUPERIORITY||Difference in LSM|2.4|STANDARD_ERROR_OF_MEAN|0.9||0.0138|TWO_SIDED|95.0|0.5|4.2||Difference between means,p-value,and CIs are estimated comparing each Seladelpar level with placebo using ANCOVA model.Treatment group as factor,baseline PBC 40 QoL domain score as covariate, change from baseline in domain score as response variable.|ANCOVA|||Symptoms Domain Score||4.2|0.5|0.0138
72455464|NCT02609048|144434122|SUPERIORITY||Difference in LSM|0.3|STANDARD_ERROR_OF_MEAN|0.98||0.7911|TWO_SIDED|95.0|-1.8|2.3||Difference between means,p-value,and CIs are estimated comparing Seladelpar 200 mg versus 50 mg using ANCOVA model.Treatment group as factor,baseline PBC 40 QoL domain score as covariate, change from baseline in domain score as response variable.|ANCOVA|||Symptoms Domain Score||2.3|-1.8|0.7911
72391980|NCT03845985|144291192|SUPERIORITY|||||||0.838||||||Analysis was significantly underpowered.|t-test, 2 sided|||||||.838
72391981|NCT03845985|144291193|SUPERIORITY|||||||0.62||||||Analysis was significantly underpowered.|t-test, 2 sided|||||||.620
72391982|NCT03845985|144291194|SUPERIORITY|||||||0.713||||||Analysis was significantly underpowered.|t-test, 2 sided|||||||.713
72391983|NCT03845985|144291195|SUPERIORITY|||||||0.509||||||Analysis was significantly underpowered.|t-test, 2 sided|||||||.509
72391984|NCT03845985|144291196|SUPERIORITY|||||||0.491||||||Analysis was significantly underpowered.|t-test, 2 sided|||||||.491
72391985|NCT03845985|144291197|SUPERIORITY|||||||0.715||||||Analysis was significantly underpowered.|t-test, 2 sided|||||||.715
72391986|NCT03845985|144291198|SUPERIORITY|||||||0.665||||||Analysis was significantly underpowered.|t-test, 2 sided|||||||.665
72391987|NCT03845985|144291199|SUPERIORITY|||||||0.875||||||Analysis was significantly underpowered.|t-test, 2 sided|||||||.875
72391988|NCT03845985|144291200|SUPERIORITY|||||||0.61||||||Analysis was significantly underpowered.|t-test, 2 sided|||Comparison of the Risk and Aggression/Liquid Courage/Sociability Subscale||||.610
72391989|NCT03845985|144291200|SUPERIORITY|||||||0.658||||||Analysis was significantly underpowered.|t-test, 2 sided|||Comparison of the Self-Perception/Cognitive and Behavioral Impairment Subscale||||.658
72391990|NCT03845985|144291200|SUPERIORITY|||||||1||||||Analysis was significantly underpowered.|t-test, 2 sided|||Comparison of the Sexuality Subscale||||1.000
72391991|NCT03845985|144291200|SUPERIORITY|||||||0.007||||||Analysis was significantly underpowered.|t-test, 2 sided|||Comparison of the Tension Reduction Subscale||||.007
72391992|NCT03845985|144291201|SUPERIORITY|||||||0.407||||||Analysis was significantly underpowered.|t-test, 2 sided|||||||.407
72562865|NCT01049412|144657472|SUPERIORITY_OR_OTHER||Least Squares Mean Difference (Final)|-0.54|STANDARD_ERROR_OF_MEAN|0.3||0.079|TWO_SIDED|90.0|-1.05|-0.03||"The statistical significance level is 0.10.~P-value is for midday pre-meal BG."|Mixed Models Analysis|||||-0.03|-1.05|0.079
72391993|NCT03845985|144291202|SUPERIORITY|||||||0.893||||||Analysis was significantly underpowered.|t-test, 2 sided|||||||.893
72391994|NCT03845985|144291203|SUPERIORITY|||||||0.709||||||Analysis was significantly underpowered.|t-test, 2 sided|||||||.709
72455465|NCT02485925|144434123|OTHER||Proportion of participants|80.7|||||TWO_SIDED|95.0|73.9|86.4|||||||95% confidence interval is based on Clopper-Pearson confidence interval|86.4|73.9|
72391995|NCT04974697|144291239|SUPERIORITY|The superiority of the test lens was concluded if the lower credible limit of the mean was above the pre-defined threshold 40 points for myope.|Least-square Mean|58.1|STANDARD_ERROR_OF_MEAN|3.37|||TWO_SIDED|95.0|50.9|65.4|||Mixed Models Analysis|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.||It was calculated using a 2-sided one sample means t-test with a family wise type I error rate of 5% and at least 80% statistical power, that 22 subjects were required to test superiority for myope.||65.4|50.9|
72391996|NCT04974697|144291239|SUPERIORITY|The superiority of the test lens was concluded if the lower credible limit of the mean was above the pre-defined threshold 32 points for hyperope.|Least-square Mean|55.0|STANDARD_ERROR_OF_MEAN|3.7|||TWO_SIDED|95.0|47.2|62.8|||Mixed Models Analysis|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.||It was calculated using a 2-sided one sample means t-test with a family wise type I error rate of 5% and at least 80% statistical power, that 18 subjects were required to test superiority for hyperope.||62.8|47.2|
72455466|NCT02485925|144434124|OTHER||Proportion of participants|99.5|||||TWO_SIDED|95.0|97.2|100.0|||||||95% confidence interval is based on Clopper-Pearson confidence interval|100.0|97.2|
72455467|NCT04181788|144434133|OTHER|Ratio of experimental vs control|Ratio of experimental vs control|231.2|||||TWO_SIDED|90.0|190.09|281.21||||||Phase 2 600 mg SC Q6W (experimental) vs. Phase 2 300 mg SC Q4W (control)||281.21|190.09|
72370409|NCT01708902|144251478|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-32.42|STANDARD_ERROR_OF_MEAN|3.19|<|0.0001|TWO_SIDED|95.0|-38.67|-26.16|||ANCOVA||The adjusted mean difference was calculated as the adjusted mean of 'Main: Linagliptin 2.5mg / Metformin 1000mg BID' minus 'Main: Linagliptin 5mg QD'.|The model includes continuous baseline HbA1c, continuous baseline FPG and treatment group.||-26.16|-38.67|<0.0001
72370410|NCT01708902|144251478|SUPERIORITY_OR_OTHER||Median Difference (Net)|-9.47|STANDARD_ERROR_OF_MEAN|3.16||0.0028|TWO_SIDED|95.0|-15.66|-3.27|||ANCOVA||The adjusted mean difference was calculated as the adjusted mean of 'Main: Linagliptin 2.5mg / Metformin 500mg BID' minus 'Main: Metformin 500mg BID'.|The model includes continuous baseline HbA1c, continuous baseline FPG and treatment group.||-3.27|-15.66|0.0028
72455468|NCT04181788|144434134|OTHER|Ratio of experimental vs control|Ratio of experimental vs control|111.48|||||TWO_SIDED|90.0|86.31|143.99||||||Phase 2 600 mg SC Q6W (experimental) vs. Phase 2 300 mg SC Q4W (control)||143.99|86.31|
72455469|NCT06922643|144434167|OTHER||Odds Ratio (OR)|6.73||||0.008|TWO_SIDED|95.0|1.63|27.8|||Regression, Logistic|||||27.8|1.63|0.008
72455470|NCT02678455|144434177|SUPERIORITY||Risk Difference (RD)|0.028|||||TWO_SIDED|95.0|-0.216|0.141|||||Adjusted proportion difference (TV005 minus Placebo) with inverse variance weighting and Newcombe Score confidence intervals.|Erythema||0.141|-0.216|
72455471|NCT02678455|144434177|SUPERIORITY||Risk Difference (RD)|0.028|||||TWO_SIDED|95.0|-0.216|0.141|||||Adjusted proportion difference (TV005 minus Placebo) with inverse variance weighting and Newcombe Score confidence intervals.|Swelling||0.141|-0.216|
72455472|NCT02678455|144434177|SUPERIORITY||Risk Difference (RD)|0.028|||||TWO_SIDED|95.0|-0.135|0.119|||||Adjusted proportion difference (TV005 minus Placebo) with inverse variance weighting and Newcombe Score confidence intervals.|ALT Increased||0.119|-0.135|
72455473|NCT02678455|144434177|SUPERIORITY||Risk Difference (RD)|0.028|||||TWO_SIDED|95.0|-0.135|0.119|||||Adjusted proportion difference (TV005 minus Placebo) with inverse variance weighting and Newcombe Score confidence intervals.|Hemoglobin Decreased||0.119|-0.135|
72500057|NCT00190775|144530127|SUPERIORITY_OR_OTHER|||||||0.005||95.0||||P-Value for ADHD Index Subscale.|ANCOVA|Model included visit by therapy, pooled investigator, child with ADHD, and baseline.||||||0.005
72562866|NCT01049412|144657472|SUPERIORITY_OR_OTHER||Least Squares Mean Difference (Final)|-0.52|STANDARD_ERROR_OF_MEAN|0.28||0.07|TWO_SIDED|90.0|-0.99|-0.05||"The statistical significance level is 0.10.~P-value is for midday 2-hr postprandial BG."|Mixed Models Analysis|||||-0.05|-0.99|0.070
72370411|NCT01708902|144251478|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-24.31|STANDARD_ERROR_OF_MEAN|3.17|<|0.0001|TWO_SIDED|95.0|-30.54|-18.08|||ANCOVA||The adjusted mean difference was calculated as the adjusted mean of 'Main: Linagliptin 2.5mg / Metformin 500mg BID' minus 'Main: Linagliptin 5mg QD'.|The model includes continuous baseline HbA1c, continuous baseline FPG and treatment group.||-18.08|-30.54|<0.0001
72370412|NCT01708902|144251479|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-35.21|STANDARD_ERROR_OF_MEAN|9.23||0.0002|TWO_SIDED|95.0|-53.48|-16.95|||ANCOVA||The adjusted mean difference was calculated as the adjusted mean of 'APG: Linagliptin 2.5mg / Metformin 1000mg BID' minus 'APG: Linagliptin 5mg QD'.|The model includes continuous baseline HbA1c, continuous baseline FPG and treatment group.||-16.95|-53.48|0.0002
72370413|NCT01708902|144251480|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.209|STANDARD_ERROR_OF_MEAN|0.148||0.0271|TWO_SIDED|95.0|0.052|0.838|||Regression, Logistic|||"Comparison of 'Main: Linagliptin 2.5mg / Metformin 1000mg BID' / 'Main: Linagliptin 5mg QD'.~The logistic regression includes treatment and continuous baseline HbA1c. The validity of the model is questionable as there is possibly a quasi-complete separation of data points, the results shown are based on the last maximum likelihood iteration."||0.838|0.052|0.0271
72455474|NCT02678455|144434177|SUPERIORITY||Risk Difference (RD)|0.02|||||TWO_SIDED|95.0|-0.205|0.121|||||Adjusted proportion difference (TV005 minus Placebo) with inverse variance weighting and Newcombe Score confidence intervals.|Leukocytosis||0.121|-0.205|
72455475|NCT02678455|144434177|SUPERIORITY||Risk Difference (RD)|0.024|||||TWO_SIDED|95.0|-0.127|0.111|||||Adjusted proportion difference (TV005 minus Placebo) with inverse variance weighting and Newcombe Score confidence intervals.|PTT Prolonged||0.111|-0.127|
72455476|NCT02678455|144434177|SUPERIORITY||Risk Difference (RD)|0.056|||||TWO_SIDED|95.0|0.022|0.134|||||Adjusted proportion difference (TV005 minus Placebo) with inverse variance weighting and Newcombe Score confidence intervals.|Thrombocytopenia||0.134|0.022|
72455477|NCT02678455|144434177|SUPERIORITY||Risk Difference (RD)|0.051|||||TWO_SIDED|95.0|0.018|0.118|||||Adjusted proportion difference (TV005 minus Placebo) with inverse variance weighting and Newcombe Score confidence intervals.|Fever||0.118|0.018|
72455478|NCT02678455|144434177|SUPERIORITY||Risk Difference (RD)|-0.036|||||TWO_SIDED|95.0|-0.203|0.089|||||Adjusted proportion difference (TV005 minus Placebo) with inverse variance weighting and Newcombe Score confidence intervals.|Headache||0.089|-0.203|
72455479|NCT02678455|144434177|SUPERIORITY||Risk Difference (RD)|0.166|||||TWO_SIDED|95.0|0.016|0.275|||||Adjusted proportion difference (TV005 minus Placebo) with inverse variance weighting and Newcombe Score confidence intervals.|Rash||0.275|0.016|
72455480|NCT02678455|144434177|SUPERIORITY||Risk Difference (RD)|0.063|||||TWO_SIDED|95.0|0.03|0.126|||||Adjusted proportion difference (TV005 minus Placebo) with inverse variance weighting and Newcombe Score confidence intervals.|Arthralgia||0.126|0.030|
72455481|NCT02678455|144434177|SUPERIORITY||Risk Difference (RD)|0.023|||||TWO_SIDED|95.0|-0.155|0.118|||||Adjusted proportion difference (TV005 minus Placebo) with inverse variance weighting and Newcombe Score confidence intervals.|Fatigue||0.118|-0.155|
72455482|NCT02678455|144434177|SUPERIORITY||Risk Difference (RD)|0.041|||||TWO_SIDED|95.0|-0.105|0.105|||||Adjusted proportion difference (TV005 minus Placebo) with inverse variance weighting and Newcombe Score confidence intervals.|Myalgia||0.105|-0.105|
72455483|NCT02678455|144434177|SUPERIORITY||Risk Difference (RD)|0.019|||||TWO_SIDED|95.0|-0.16|0.114|||||Adjusted proportion difference (TV005 minus Placebo) with inverse variance weighting and Newcombe Score confidence intervals.|Nausea||0.114|-0.160|
72455484|NCT02678455|144434177|SUPERIORITY||Risk Difference (RD)|0.028|||||TWO_SIDED|95.0|-0.216|0.141|||||Adjusted proportion difference (TV005 minus Placebo) with inverse variance weighting and Newcombe Score confidence intervals.|Photophobia||0.141|-0.216|
72455485|NCT02678455|144434177|SUPERIORITY||Risk Difference (RD)|0.024|||||TWO_SIDED|95.0|-0.142|0.088|||||Adjusted proportion difference (TV005 minus Placebo) with inverse variance weighting and Newcombe Score confidence intervals.|Retro-orbital Pain||0.088|-0.142|
72455486|NCT02678455|144434177|SUPERIORITY||Risk Difference (RD)|0.028|||||TWO_SIDED|95.0|-0.216|0.141|||||Adjusted proportion difference (TV005 minus Placebo) with inverse variance weighting and Newcombe Score confidence intervals.|Decrease in Activity||0.141|-0.216|
72455487|NCT02678455|144434177|SUPERIORITY||Risk Difference (RD)|0.028|||||TWO_SIDED|95.0|-0.216|0.141|||||Adjusted proportion difference (TV005 minus Placebo) with inverse variance weighting and Newcombe Score confidence intervals.|Loss of Appetite||0.141|-0.216|
72455488|NCT02678455|144434177|SUPERIORITY||Risk Difference (RD)|0.083|||||TWO_SIDED|95.0|-0.165|0.218|||||Adjusted proportion difference (TV005 minus Placebo) with inverse variance weighting and Newcombe Score confidence intervals.|Vomiting||0.218|-0.165|
72455489|NCT02678455|144434178|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|83.0|||||TWO_SIDED|95.0|76.0|88.0||||||All study participants seropositive to DENV-1 post TV005 Vaccination There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||88|76|
72455490|NCT02678455|144434178|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|99.0|||||TWO_SIDED|95.0|96.0|100.0||||||All study participants seropositive to DENV-2 post TV005 Vaccination. There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||100|96|
72455491|NCT02678455|144434178|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm|percentage seropositive|96.0|||||TWO_SIDED|95.0|92.0|98.0||||||All study participants seropositive to DENV-3 post TV005 Vaccination There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||98|92|
72455492|NCT02678455|144434178|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|87.0|||||TWO_SIDED|95.0|81.0|92.0||||||All study participants seropositive to DENV-4 post TV005 Vaccination There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||92|81|
72455493|NCT02678455|144434178|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|86.0|||||TWO_SIDED|95.0|71.0|94.0||||||Adult study participants seropositive to DENV-1 post TV005 Vaccination There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||94|71|
72455494|NCT02678455|144434178|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|97.0|||||TWO_SIDED|95.0|85.0|99.0||||||Adult study participants seropositive to DENV-2 post TV005 Vaccination There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||99|85|
72455495|NCT02678455|144434178|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|97.0|||||TWO_SIDED|95.0|85.0|99.0||||||Adult study participants seropositive to DENV-3 post TV005 Vaccination There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||99|85|
72455496|NCT02678455|144434178|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|91.0|||||TWO_SIDED|95.0|78.0|97.0||||||Adult study participants seropositive to DENV-4 post TV005 Vaccination There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||97|78|
72455497|NCT02678455|144434178|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|83.0|||||TWO_SIDED|95.0|67.0|92.0||||||Adolescent study participants seropositive to DENV-1 post TV005 Vaccination There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||92|67|
72455498|NCT02678455|144434178|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|100.0|||||TWO_SIDED|95.0|90.0|100.0||||||Adolescent study participants seropositive to DENV-2 post TV005 Vaccination There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||100|90|
72455499|NCT02678455|144434178|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|97.0|||||TWO_SIDED|95.0|85.0|99.0||||||Adolescent study participants seropositive to DENV-3 post TV005 Vaccination There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||99|85|
72455500|NCT02678455|144434178|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|86.0|||||TWO_SIDED|95.0|71.0|94.0||||||Adolescent study participants seropositive to DENV-4 post TV005 Vaccination There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||94|71|
72455501|NCT02678455|144434178|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|81.0|||||TWO_SIDED|95.0|65.0|90.0||||||Children study participants seropositive to DENV-1 post TV005 Vaccination There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||90|65|
72455502|NCT02678455|144434178|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|100.0|||||TWO_SIDED|95.0|90.0|100.0||||||Children study participants seropositive to DENV-2 post TV005 Vaccination There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||100|90|
72455503|NCT02678455|144434178|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|100.0|||||TWO_SIDED|95.0|90.0|100.0||||||Children study participants seropositive to DENV-3 post TV005 Vaccination There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||100|90|
72455504|NCT02678455|144434178|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|78.0|||||TWO_SIDED|95.0|62.0|88.0||||||Children study participants seropositive to DENV-4 post TV005 Vaccination There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||88|62|
72455505|NCT02678455|144434178|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|83.0|||||TWO_SIDED|95.0|68.0|92.0||||||Young Children study participants seropositive to DENV-1 post TV005 Vaccination There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||92|68|
72455506|NCT02678455|144434178|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|100.0|||||TWO_SIDED|95.0|90.0|100.0||||||Young Children study participants seropositive to DENV-2 post TV005 Vaccination There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||100|90|
72455507|NCT02678455|144434178|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|92.0|||||TWO_SIDED|95.0|78.0|97.0||||||Young Children study participants seropositive to DENV-3 post TV005 Vaccination There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||97|78|
72455508|NCT02678455|144434178|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|94.0|||||TWO_SIDED|95.0|82.0|98.0||||||Young Children study participants seropositive to DENV-4 post TV005 Vaccination There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||98|82|
72455509|NCT02678455|144434180|SUPERIORITY||||||<|0.001||||||Comparison between experienced vs dengue naive volunteers post TV005 vaccination. Logistic model to adjust for age cohort provides unstable estimates due to quasi separation of data.|Fisher Exact|||DENV-1 percent seropositive post TV005 vaccination: difference between experienced at baseline and naive at baseline||||<0.001
72455510|NCT02678455|144434180|SUPERIORITY|||||||1||||||Comparison between experienced vs. dengue naive volunteers post TV005 vaccination. Logistic model to adjust for age cohort provides unstable estimates due to quasi separation of data.|Fisher Exact|||DENV-2 percent seropositive post TV005 vaccination: difference between experienced at baseline and naive at baseline||||1.00
72455511|NCT02678455|144434180|SUPERIORITY|||||||0.07||||||Comparison between experienced vs. dengue naive volunteers post TV005 vaccination. Logistic model to adjust for age cohort provides unstable estimates due to quasi separation of data.|Fisher Exact|||DENV-3 percent seropositive post TV005 vaccination: difference between experienced at baseline and naive at baseline||||0.070
72455512|NCT02678455|144434180|SUPERIORITY|||||||1||||||Comparison between experienced vs. dengue naive volunteers post TV005 vaccination. logistic model to adjust for age cohort provides unstable estimates due to quasi separation of data.|Fisher Exact|||DENV-4 percent seropositive post TV005 vaccination: difference between experienced at baseline and naive at baseline||||1.00
72455513|NCT02678455|144434181|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|66.0|||||TWO_SIDED|95.0|49.0|79.0||||||Adult cohort: percent seropositive to DENV-1 at study day 0 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||79|49|
72455514|NCT02678455|144434181|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|83.0|||||TWO_SIDED|95.0|67.0|92.0||||||Adult cohort: percent seropositive to DENV-1 at study day 28 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||92|67|
72455515|NCT02678455|144434181|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|80.0|||||TWO_SIDED|95.0|64.0|90.0||||||Adult cohort: percent seropositive to DENV-1 at study day 56 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||90|64|
72455516|NCT02678455|144434181|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|80.0|||||TWO_SIDED|95.0|64.0|90.0||||||Adult cohort: percent seropositive to DENV-1 at study day 180 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||90|64|
72455517|NCT02678455|144434181|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|80.0|||||TWO_SIDED|95.0|64.0|90.0||||||Adult cohort: percent seropositive to DENV-1 at study day 360 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||90|64|
72455518|NCT02678455|144434181|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|66.0|||||TWO_SIDED|95.0|49.0|79.0||||||Adult cohort: percent seropositive to DENV-1 at study day 720 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||79|49|
72500058|NCT00190775|144530128|SUPERIORITY_OR_OTHER|||||||0.546||95.0||||P-Value for Total ADHD Symptoms Score.|ANCOVA|Model included visit by therapy, pooled investigator, child with ADHD, and baseline.||||||0.546
72500059|NCT00190775|144530128|SUPERIORITY_OR_OTHER|||||||0.53||95.0||||P-Value for Hyper/Impulsive Subscale.|ANCOVA|Model included visit by therapy, pooled investigator, child with ADHD, and baseline.||||||0.530
72500060|NCT00190775|144530128|SUPERIORITY_OR_OTHER|||||||0.569||95.0||||P-Value for Inattention Subscale.|ANCOVA|Model included visit by therapy, pooled investigator, child with ADHD, and baseline.||||||0.569
72500061|NCT00190775|144530128|SUPERIORITY_OR_OTHER|||||||0.986||95.0||||P-Vaue for ADHD Index Subscale.|ANCOVA|Model included visit by therapy, pooled investigator, child with ADHD, and baseline.||||||0.986
72562867|NCT01049412|144657472|SUPERIORITY_OR_OTHER||Least Squares Mean Difference (Final)|-0.86|STANDARD_ERROR_OF_MEAN|0.32||0.008|TWO_SIDED|90.0|-1.39|-0.34||"The statistical significance level is 0.10.~P-value is for evening pre-meal BG."|Mixed Models Analysis|||||-0.34|-1.39|0.008
72562868|NCT01049412|144657472|SUPERIORITY_OR_OTHER||Least Squares Mean Difference (Final)|-0.89|STANDARD_ERROR_OF_MEAN|0.29||0.003|TWO_SIDED|90.0|-1.38|-0.41||"The statistical significance level is 0.10.~P-value is for evening 2-hr postprandial BG."|Mixed Models Analysis|||||-0.41|-1.38|0.003
72455519|NCT02678455|144434181|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|66.0|||||TWO_SIDED|95.0|49.0|79.0||||||Adult cohort: percent seropositive to DENV-1 at study day 1080 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||79|49|
72455520|NCT02678455|144434181|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|69.0|||||TWO_SIDED|95.0|52.0|81.0||||||Adult cohort: percent seropositive to DENV-2 at study day 0 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||81|52|
72455521|NCT02678455|144434181|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|94.0|||||TWO_SIDED|95.0|81.0|98.0||||||Adult cohort: percent seropositive to DENV-2 at stud day 28 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||98|81|
72455522|NCT02678455|144434181|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|97.0|||||TWO_SIDED|95.0|85.0|99.0||||||Adult cohort: percent seropositive to DENV-2 at study day 56 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||99|85|
72455523|NCT02678455|144434181|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|89.0|||||TWO_SIDED|95.0|74.0|95.0||||||Adult cohort: percent seropositive to DENV-2 at study day 180. There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||95|74|
72455524|NCT02678455|144434181|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|89.0|||||TWO_SIDED|95.0|74.0|95.0||||||Adult cohort: percent seropositive to DENV-2 at study day 360 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||95|74|
72500062|NCT00700804|144530169|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.7|STANDARD_DEVIATION|2.5||0.05|||||||Mixed Models Analysis|Effects of calcium (Ca), protein \& their interaction were tested using repeated measures analysis of variance (subjects nested under High or Low Ca)|Reported analysis is the main effect of Calcium (High vs Low) from the Mixed Model Analysis which averages across the two levels of dietary protein. The main effect of protein and the calcium x protein interaction were not statistically significant.|||||0.05
72500063|NCT01511445|144530170|NON_INFERIORITY|The noninferiority margin was specified as 15 NDI points (0-100 scale).|Mean Difference (Final Values)|-1.3|STANDARD_ERROR_OF_MEAN|2.96||0.641|TWO_SIDED|95.0|-7.3|4.5|||Fisher Exact||A negative value means that the PEEK change was slightly larger than the silicon nitride study arm.|The null hypothesis was that the mean change in NDI scores from pre-op to 24 months was equal in the two study arms.||4.5|-7.3|0.641
72500064|NCT01511445|144530171|NON_INFERIORITY|The definition of fusion is rotation on flexion-extension films of less than or equal to four degrees and translation less than 1.25 mm.||||||0.71|||||||Fisher Exact|||The null hypothesis was that the fusion rates would be equal in the two study arms. The comparison includes patients with flexion-extension films at 24 months (as-treated population).||||0.710
72562869|NCT01049412|144657472|SUPERIORITY_OR_OTHER||Least Squares Mean Difference (Final)|-1.1|STANDARD_ERROR_OF_MEAN|0.33||0.001|TWO_SIDED|90.0|-1.64|-0.55||"The statistical significance level is 0.10.~P-value is for bed time BG."|Mixed Models Analysis|||||-0.55|-1.64|0.001
72562870|NCT01049412|144657477|SUPERIORITY_OR_OTHER|||||||0.037||95.0||||The statistical significance level is 0.10.|Negative Binomial Model|||||||0.037
72562871|NCT01049412|144657478|SUPERIORITY_OR_OTHER||Least Squares Mean Difference (Final)|-0.47|STANDARD_ERROR_OF_MEAN|0.13|<|0.001|TWO_SIDED|90.0|-0.69|-0.25||The statistical significance level is 0.10.|Mixed Models Analysis|||||-0.25|-0.69|<0.001
72391997|NCT04974697|144291240|SUPERIORITY|The superiority of the Test lens was concluded if the upper credible limit of the mean was below the pre-defined threshold 0.00 logMAR for Distance.|Least-square Mean|-0.129|STANDARD_ERROR_OF_MEAN|0.0166|||TWO_SIDED|95.0|-0.167|-0.091|||Mixed Models Analysis|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.||It was calculated by using a 2-sided one sample mean t-test with a family wise type I error rate of 5% and at least 80% statistical power , 42 subjects were required to test superiority for distance (4m).||-0.091|-0.167|
72391998|NCT04974697|144291240|SUPERIORITY|The superiority of the Test lens was concluded if the upper credible limit of the mean was below the pre-defined threshold +0.17 logMAR for Intermediate.|Least-square Mean|-0.046|STANDARD_ERROR_OF_MEAN|0.0166|||TWO_SIDED|95.0|-0.084|-0.008|||Mixed Models Analysis|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.||It was calculated by using a 2-sided one sample mean t-test with a family wise type I error rate of 5% and at least 80% statistical power , 7 subjects were required to test superiority for intermediate (64 cm).||-0.008|-0.084|
72455525|NCT02678455|144434181|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|91.0|||||TWO_SIDED|95.0|78.0|97.0||||||Adult cohort: percent seropositive to DENV-2 at study day 720 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||97|78|
72455526|NCT02678455|144434181|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|86.0|||||TWO_SIDED|95.0|71.0|94.0||||||Adult cohort: percent seropositive to DENV-2 at study day 1080 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||94|71|
72455527|NCT02678455|144434181|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|71.0|||||TWO_SIDED|95.0|55.0|84.0||||||Adult cohort: percent seropositive to DENV-3 at study day 0 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||84|55|
72455528|NCT02678455|144434181|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|94.0|||||TWO_SIDED|95.0|81.0|98.0||||||Adult cohort: percent seropositive to DENV-3 at study day 28 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||98|81|
72562872|NCT03756883|144657479|EQUIVALENCE|The 90% Confidence Interval for the test-to-reference ratio was calculated using a procedure similar to Fieller's method.|Test-to-Reference Ratio|101.8|||||TWO_SIDED|90.0|92.68|111.94||||||||111.94|92.68|
72562873|NCT03756883|144657480|EQUIVALENCE|The 90% confidence interval for the test-to-reference ratio was calculated using a procedure similar to Fieller's method.|Test-to-Reference Ratio|98.09|||||TWO_SIDED|90.0|87.1|110.61||||||||110.61|87.10|
72455529|NCT02678455|144434181|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|91.0|||||TWO_SIDED|95.0|78.0|97.0||||||Adult cohort: percent seropositive to DENV-3 at study day 56 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||97|78|
72455530|NCT02678455|144434181|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|89.0|||||TWO_SIDED|95.0|74.0|95.0||||||Adult cohort: percent seropositive to DENV-3 at study day 180 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||95|74|
72455531|NCT02678455|144434181|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|86.0|||||TWO_SIDED|95.0|71.0|94.0||||||Adult cohort: percent seropositive to DENV-3 at study day 360 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||94|71|
72455532|NCT02678455|144434181|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|89.0|||||TWO_SIDED|95.0|74.0|95.0||||||Adult cohort: percent seropositive to DENV-3 at study day 720 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||95|74|
72455533|NCT02678455|144434181|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|80.0|||||TWO_SIDED|95.0|64.0|90.0||||||Adult cohort: percent seropositive to DENV-3 at study day 1080 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||90|64|
72455534|NCT02678455|144434181|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|20.0|||||TWO_SIDED|95.0|10.0|36.0||||||Adult cohort: percent seropositive to DENV-4 at study day 0 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||36|10|
72455535|NCT02678455|144434181|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|77.0|||||TWO_SIDED|95.0|61.0|88.0||||||Adult cohort: percent seropositive to DENV-4 at study day 28 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||88|61|
72562874|NCT03756883|144657481|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||Superiority of the test product over the placebo.||||<0.0001
72455536|NCT02678455|144434181|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|80.0|||||TWO_SIDED|95.0|64.0|90.0||||||Adult cohort: percent seropositive to DENV-4 at study day 56 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||90|64|
72455537|NCT02678455|144434181|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|74.0|||||TWO_SIDED|95.0|58.0|86.0||||||Adult cohort: percent seropositive to DENV-4 at study day 180 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||86|58|
72455538|NCT02678455|144434181|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|66.0|||||TWO_SIDED|95.0|49.0|79.0||||||Adult cohort: percent seropositive to DENV-4 at study day 360 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||79|49|
72562875|NCT03756883|144657481|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||Superiority of Reference to placebo.||||<0.0001
72455539|NCT02678455|144434181|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|60.0|||||TWO_SIDED|95.0|44.0|74.0||||||Adult cohort: percent seropositive to DENV-4 at study day 720 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||74|44|
72455540|NCT02678455|144434181|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|63.0|||||TWO_SIDED|95.0|46.0|77.0||||||Adult cohort: percent seropositive to DENV-4 at study day 1080 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||77|46|
72455541|NCT02678455|144434181|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|26.0|||||TWO_SIDED|95.0|14.0|42.0||||||Adolescent cohort: percent seropositive to DENV-1 a study day 0 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||42|14|
72455542|NCT02678455|144434181|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|74.0|||||TWO_SIDED|95.0|58.0|86.0||||||Adolescent cohort: percent seropositive to DENV-1 at study day 28 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||86|58|
72455543|NCT02678455|144434181|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|71.0|||||TWO_SIDED|95.0|55.0|84.0||||||Adolescent cohort: percent seropositive to DENV-1 at study day 56 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||84|55|
72455544|NCT02678455|144434181|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|71.0|||||TWO_SIDED|95.0|55.0|84.0||||||Adolescent cohort: percent seropositive to DENV-1 at study day 180 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||84|55|
72562876|NCT03756883|144657482|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||Superiority of test over placebo.||||<0.0001
72455545|NCT02678455|144434181|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|69.0|||||TWO_SIDED|95.0|52.0|81.0||||||Adolescent cohort: percent seropositive to DENV-1 at study day 360 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||81|52|
72562877|NCT03756883|144657482|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||Superiority of reference to placebo.||||<0.0001
72562878|NCT01546519|144657489|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.3|||||TWO_SIDED|90.0|0.95|1.78||||||Cmax Mild HI vs. Normal: Based on pooled variance estimates||1.78|0.95|
72562879|NCT01546519|144657489|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.3|||||TWO_SIDED|90.0|0.92|1.83||||||Cmax Moderate HI vs. Normal: Based on pooled variance estimates||1.83|0.92|
72562880|NCT01546519|144657489|SUPERIORITY_OR_OTHER||Geometric mean ratio|0.87|||||TWO_SIDED|90.0|0.55|1.37||||||Cmax Severe HI vs. Normal: Based on pooled variance estimates||1.37|0.55|
72391999|NCT04974697|144291240|SUPERIORITY|The superiority of the Test lens was concluded if the upper credible limit of the mean was below the pre-defined threshold +0.17 logMAR for Near.|Least-square Mean|0.067|STANDARD_ERROR_OF_MEAN|0.0166|||TWO_SIDED|95.0|0.029|0.105|||Mixed Models Analysis|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.||It was calculated by using a 2-sided one sample mean t-test with a family wise type I error rate of 5% and at least 80% statistical power , 36 subjects were required to test superiority for near (40 cm).||0.105|0.029|
72392000|NCT04974697|144291241|NON_INFERIORITY|The non-inferiority of the test lens was concluded if the lower credible limit of the mean was above the pre-defined threshold -5 points for myope.|Least-square Mean|8.4|STANDARD_ERROR_OF_MEAN|2.66|||TWO_SIDED|95.0|3.1|13.7|||Mixed Models Analysis|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.||The study was only powered for the primary endpoint.||13.7|3.1|
72392001|NCT04974697|144291241|NON_INFERIORITY|The non-inferiority of the test lens was concluded if the lower credible limit of the mean was above the pre-defined threshold -5 points for hyperope.|Least-square Mean|5.0|STANDARD_ERROR_OF_MEAN|3.12|||TWO_SIDED|95.0|-1.2|11.2|||Mixed Models Analysis|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.||The study was only powered for the primary endpoint.||11.2|-1.2|
72392002|NCT04974697|144291242|NON_INFERIORITY|The non-inferiority of the test lens was concluded if the lower credible limit of the mean was above the pre-defined threshold -5 points for myope.|Least-square Mean|6.9|STANDARD_ERROR_OF_MEAN|3.44|||TWO_SIDED|95.0|0.0|13.7|||Mixed Models Analysis|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.||The study was only powered for the primary endpoint.||13.7|0.0|
72392003|NCT04974697|144291242|NON_INFERIORITY|The non-inferiority of the test lens was concluded if the lower credible limit of the mean was above the pre-defined threshold -5 points for hyperope.|Least-square Mean|3.3|STANDARD_ERROR_OF_MEAN|4.03|||TWO_SIDED|95.0|-4.7|11.3|||Mixed Models Analysis|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.||The study was only powered for the primary endpoint.||11.3|-4.7|
72392004|NCT04974697|144291243|NON_INFERIORITY|The non-inferiority of the test lens was concluded if the lower credible limit of the mean was above the pre-defined threshold -5 points for myope.|Least-square Mean|11.2|STANDARD_ERROR_OF_MEAN|3.11|||TWO_SIDED|95.0|5.0|17.4|||Mixed Models Analysis|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.||The study was only powered for the primary endpoint.||17.4|5.0|
72392005|NCT04974697|144291243|NON_INFERIORITY|The non-inferiority of the test lens was concluded if the lower credible limit of the mean was above the pre-defined threshold -5 points for hyperope.|Least-square Mean|10.0|STANDARD_ERROR_OF_MEAN|3.64|||TWO_SIDED|95.0|2.8|17.3|||Mixed Models Analysis|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.||The study was only powered for the primary endpoint.||17.3|2.8|
72392006|NCT04659161|144291266|SUPERIORITY||LS mean difference|-9.6|||<|0.0001|TWO_SIDED|95.0|-13.9|-5.2|||Mixed Model for Repeated Measures||||Statistics are from a mixed model for repeated measures (MMRM). The model includes the treatment group (KarXT or placebo), visit, and the interaction between the treatment group and visit as fixed factors, and baseline PANSS total score, site, age, and gender as covariates. An unstructured covariance matrix is used to model the correlation among repeated measurements and the denominator degrees of freedom are computed using the Kenward-Roger method.|-5.2|-13.9|<0.0001
72392007|NCT04659161|144291267|SUPERIORITY||||||<|0.0001|||||||Mixed Model for Repeated Measures|||||||<0.0001
72392008|NCT04659161|144291268|SUPERIORITY|||||||0.0055|||||||Mixed Model Repeated Measures|||||||0.0055
72392009|NCT04659161|144291269|SUPERIORITY|||||||0.0022|||||||Mixed Model for Repeated Measures|||||||0.0022
72392010|NCT04659161|144291270|SUPERIORITY||||||<|0.0001|||||||Mixed Model for Repeated Measures|||||||<0.0001
72392011|NCT04659161|144291271|SUPERIORITY||||||<|0.0001|||||||Mixed Model for Repeated Measures|||||||<0.0001
72392012|NCT02197130|144291280|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.52|STANDARD_ERROR_OF_MEAN|1.192||0.2033|TWO_SIDED|90.0|-0.45|3.49|||MMRM|MMRM: A linear mixed-effect repeated measures model||||3.49|-0.45|0.2033
72392013|NCT02197130|144291280|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.35|STANDARD_ERROR_OF_MEAN|1.118||0.7549|TWO_SIDED|90.0|-2.2|1.5|||MMRM|||||1.50|-2.20|0.7549
72392014|NCT02197130|144291292|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.54|STANDARD_ERROR_OF_MEAN|0.515||0.003|TWO_SIDED|90.0|0.69|2.39|||MMRM|||Week 13||2.39|0.69|0.0030
72392015|NCT02197130|144291292|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.36|STANDARD_ERROR_OF_MEAN|0.491||0.4656|TWO_SIDED|90.0|-0.45|1.17|||MMRM|||Week 13||1.17|-0.45|0.4656
72392016|NCT02197130|144291292|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.21|STANDARD_ERROR_OF_MEAN|0.492||0.0149|TWO_SIDED|90.0|0.39|2.02|||MMRM|||Week 26||2.02|0.39|0.0149
72392017|NCT02197130|144291292|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.1|STANDARD_ERROR_OF_MEAN|0.46||0.8233|TWO_SIDED|90.0|-0.66|0.86|||MMRM|||Week 26||0.86|-0.66|0.8233
72392018|NCT02197130|144291294|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.35|STANDARD_ERROR_OF_MEAN|0.148||0.0181|TWO_SIDED|90.0|0.11|0.6|||MMRM|||Week 13||0.60|0.11|0.0181
72392019|NCT02197130|144291294|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.05|STANDARD_ERROR_OF_MEAN|0.14||0.7133|TWO_SIDED|90.0|-0.18|0.28|||MMRM|||Week 13||0.28|-0.18|0.7133
72392020|NCT02197130|144291294|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.12|STANDARD_ERROR_OF_MEAN|0.163||0.4657|TWO_SIDED|90.0|-0.15|0.39|||MMRM|||Week 26||0.39|-0.15|0.4657
72392021|NCT02197130|144291294|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.03|STANDARD_ERROR_OF_MEAN|0.15||0.8339|TWO_SIDED|90.0|-0.22|0.28|||MMRM|||Week 26||0.28|-0.22|0.8339
72392022|NCT02320669|144291295|SUPERIORITY||Cox Proportional Hazard|1.083|||<|0.05|TWO_SIDED|95.0|0.82|1.432|||Regression, Cox|||||1.432|.82|<.05
72392023|NCT01362205|144291322|OTHER|||||||0.2454|||||||Wilcoxon (Mann-Whitney)|||||||0.2454
72392024|NCT03338998|144291333|SUPERIORITY||Geo-mean ratio|1.05||||0.585|TWO_SIDED|90.0|0.717|1.535|||ANCOVA|||||1.535|0.717|0.585
72392025|NCT01372462|144291335|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|Newman-Keuls multiple comparisons test||The primary endpoint was difference in endurance between nasal cannula oxygen and NIOV+O2. Assuming 153 sec clinically important difference, 183 sec SD, and α=0.05, a sample size of 15 yielded 85% power.||||<0.05
72392026|NCT01372462|144291335|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
72392027|NCT01372462|144291335|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
72392028|NCT01372462|144291336|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|Newman-Keuls multiple comparisons test||One-way, repeated-measures ANOVA and Newman-Keuls multiple comparisons test||||< 0.05
72392029|NCT01372462|144291336|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
72392030|NCT01372462|144291336|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
72392031|NCT01372462|144291337|SUPERIORITY_OR_OTHER||||||<|0.05||||||One-way, repeated-measures ANOVA and Newman-Keuls multiple comparisons tests|ANOVA|Newman-Keuls multiple comparisons tests||Per protocol||||<0.05
72392032|NCT01372462|144291337|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
72392033|NCT01372462|144291337|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
72392034|NCT00540514|144291365|SUPERIORITY_OR_OTHER_LEGACY||Response Rate Ratio|1.313||||0.005|TWO_SIDED|95.1|1.082|1.593||Statistical significance defined as P-value \< 0.049.|Chi-squared||Response rate ratio = PA/PT. A response rate ratio \> 1 favors the albumin-bound paclitaxel/carboplatin arm of the study.|The null hypothesis is that the albumin-bound paclitaxel/carboplatin regimen response rate (PA) is equal to that of the paclitaxel (Taxol)/carboplatin regimen (PT). Superiority of albumin-bound paclitaxel/carboplatin to paclitaxel/carboplatin will be established if the lower bound of the 95.1% CI of the response rate ratio is \> 1.0.||1.593|1.082|0.005
72392035|NCT00540514|144291366|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.902||||0.214|TWO_SIDED|95.1|0.767|1.06||P-value is based on a stratified log rank test stratified by geographic region (North America/Australia, Eastern Europe, or Asia/Pacific) and histology of primary diagnosis (squamous cell carcinoma, adenocarcinoma, or other carcinoma).|Log Rank||Hazard ratio (albumin-bound paclitaxel/carboplatin to paclitaxel/carboplatin) \<1 favors the albumin-bound paclitaxel/carboplatin group.|||1.060|0.767|0.214
72392036|NCT00540514|144291367|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.922||||0.271|TWO_SIDED|95.1|0.797|1.066||P-value is based on a stratified log rank test stratified by geographic region (North America/Australia, Eastern Europe, or Asia/Pacific) and histology of primary diagnosis (Squamous cell carcinoma, adenocarcinoma, or other carcinoma).|Log Rank||Hazard ratio (albumin-bound paclitaxel/carboplatin to paclitaxel/carboplatin) \<1 favors the albumin-bound paclitaxel/carboplatin group.|||1.066|0.797|0.271
72392037|NCT00540514|144291368|SUPERIORITY_OR_OTHER_LEGACY||Response Rate Ratio|1.074||||0.239|TWO_SIDED|95.0|0.953|1.21|||Chi-squared|||||1.210|0.953|0.239
72392038|NCT00540514|144291369|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.901||||0.551|TWO_SIDED|95.0|0.652|1.244||P-value is based on a stratified log rank test stratified by geographic region (North America/Australia, Eastern Europe, or Asia/Pacific) and histology of primary diagnosis (Squamous cell carcinoma or Non squamous cell carcinoma).|Log Rank||Hazard ratio (albumin-bound paclitaxel/carboplatin to paclitaxel/carboplatin) \<1 favors the albumin-bound paclitaxel/carboplatin group.|||1.244|0.652|0.551
72392039|NCT00540514|144291372|SUPERIORITY_OR_OTHER_LEGACY|||||||0.302||95.0|||||Univariate Cox regression|||SPARC correlation with overall survival for the overall SPARC population.||||0.302
72392040|NCT00540514|144291373|SUPERIORITY_OR_OTHER_LEGACY|||||||0.036||95.0||||A nonsignificant interaction P-value (ie, p-value ≥ 0.100) indicates the treatment regimen effect was consistent within a prognostic factor.|Regression, Logistic|Logistic regression model with effects for treatment regimen, prognostic factor (histology), and treatment regimen by prognostic factor interaction.||||||0.036
72392041|NCT00980057|144291464|NON_INFERIORITY|The non-inferiority margin was 12%.||||||0.0002|||||||Farrington-Manning test of two ind. prop|||||||0.0002
72392042|NCT00980057|144291465|SUPERIORITY|The pre-specified minimum objective performance criteria was 0.82|||||<|0.0001|||||||t-test, 1 sided|||||||<0.0001
72392043|NCT00980057|144291467|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
72392044|NCT00980057|144291468|NON_INFERIORITY|The non-inferiority margin is 15|||||<|0.0001|||||||t-test, 1 sided|||||||<0.0001
72392045|NCT00980057|144291469|NON_INFERIORITY|The non-inferiority margin is 2.5||||||0.0009|||||||t-test, 1 sided|||||||0.0009
72392046|NCT00980057|144291470|NON_INFERIORITY|The non-inferiority margin is 0.3|||||<|0.0001|||||||t-test, 1 sided|||||||<0.0001
72392047|NCT00980057|144291471|NON_INFERIORITY|The non-inferiority margin is 30||||||0.0002|||||||t-test, 1 sided|||||||0.0002
72392048|NCT00980057|144291472|NON_INFERIORITY|The non-inferiority margin is 5.1||||||0.002|||||||t-test, 1 sided|||||||0.002
72392049|NCT01315678|144291483|SUPERIORITY||Cox Proportional Hazard|1.51||||0.0286|TWO_SIDED|95.0|1.07|2.13|||Regression, Cox|||Stratified Cox proportional hazards model||2.13|1.07|0.0286
72392050|NCT01315678|144291484|SUPERIORITY||Cox Proportional Hazard|1.12||||0.6031|TWO_SIDED|95.0|0.76|1.66|||Regression, Cox|||||1.66|0.76|0.6031
72392051|NCT01315678|144291485|SUPERIORITY||Cox Proportional Hazard|0.84||||0.4861|TWO_SIDED|95.0|0.49|1.44|||Regression, Cox|||||1.44|0.49|0.4861
72392052|NCT05426902|144291497|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||Baseline (month 1) vs. intervention period (month 2)||||<0.0001
72392053|NCT05426902|144291498|SUPERIORITY|||||||0.6|||||||t-test, 2 sided|||Baseline (month 1) vs. intervention period (month 2)||||0.6
72392054|NCT05426902|144291499|SUPERIORITY|||||||0.2|||||||t-test, 2 sided|||Baseline (month 1) vs. intervention period (month 2)||||0.2
72392055|NCT05426902|144291500|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||Baseline (month 1) vs. intervention period (month 2)||||<0.0001
72392056|NCT05426902|144291501|SUPERIORITY|||||||0.4|||||||Fisher Exact|||Baseline (month 1) vs. intervention period (month 2)||||0.4
72392057|NCT05426902|144291506|SUPERIORITY|||||||0.7|||||||t-test, 2 sided|||"I feel good about my medical visit at baseline (month 1) vs. intervention period (month 2)."||||0.7
72392058|NCT05426902|144291506|SUPERIORITY|||||||0.8|||||||t-test, 2 sided|||"My rheumatologist gave me his/her full attention at baseline (month 1) vs. intervention period (month 2)."||||0.8
72392059|NCT05426902|144291506|SUPERIORITY|||||||1|||||||t-test, 2 sided|||"I was able to say everything I wanted to say to my rheumatologist at baseline (month 1) vs. intervention period (month 2)."||||1.0
72392060|NCT05426902|144291508|SUPERIORITY|||||||0.7|||||||t-test, 2 sided|||"My rheumatologist and I agreed on how active my lupus was today at baseline (month 1) vs. intervention period (month 2)."||||0.7
72392061|NCT05426902|144291508|SUPERIORITY|||||||0.8|||||||t-test, 2 sided|||"I understand the care recommendations that my doctor or provider gave me today at baseline (month 1) vs. intervention period (month 2)."||||0.8
72392062|NCT05426902|144291509|SUPERIORITY|||||||0.02|||||||t-test, 2 sided|||Baseline vs. Follow-Up||||0.02
72392063|NCT05426902|144291510|SUPERIORITY|||||||0.7|||||||t-test, 2 sided|||"SLE@Duke meets my approval at baseline (month 1) vs. intervention period (month 2)."||||0.7
72455546|NCT02678455|144434181|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|43.0|||||TWO_SIDED|95.0|28.0|59.0||||||Adolescent cohort: percent seropositive to DENV-1 at study day 720 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||59|28|
72455547|NCT02678455|144434181|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|46.0|||||TWO_SIDED|95.0|30.0|62.0||||||Adolescent cohort: percent seropositive to DENV-1 at study day 1080 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||62|30|
72455548|NCT02678455|144434181|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|34.0|||||TWO_SIDED|95.0|21.0|51.0||||||Adolescent cohort: percent seropositive to DENV-2 at study day 0 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||51|21|
72455549|NCT02678455|144434181|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|100.0|||||TWO_SIDED|95.0|90.0|100.0||||||Adolescent cohort: percent seropositive to DENV-2 at study day 28 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||100|90|
72455550|NCT02678455|144434181|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|97.0|||||TWO_SIDED|95.0|85.0|99.0||||||Adolescent cohort: percent seropositive to DENV-2 at study day 56 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||99|85|
72455551|NCT02678455|144434181|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|97.0|||||TWO_SIDED|95.0|85.0|99.0||||||Adolescent cohort: percent seropositive to DENV-2 at study day 180 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||99|85|
72455552|NCT02678455|144434181|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|85.0|||||TWO_SIDED|95.0|71.0|94.0||||||Adolescent cohort: percent seropositive to DENV-2 at study day 360 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||94|71|
72455553|NCT02678455|144434181|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|74.0|||||TWO_SIDED|95.0|58.0|86.0||||||Adolescent cohort: percent seropositive to DENV-2 at study day 720 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||86|58|
72455554|NCT02678455|144434181|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|69.0|||||TWO_SIDED|95.0|52.0|81.0||||||Adolescent cohort: percent seropositive to DENV-2 at study day 1080 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||81|52|
72455555|NCT02678455|144434181|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|37.0|||||TWO_SIDED|95.0|23.0|54.0||||||Adolescent cohort: percent seropositive to DENV-3 at study day 0 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||54|23|
72455556|NCT02678455|144434181|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|89.0|||||TWO_SIDED|95.0|74.0|95.0||||||Adolescent cohort: percent seropositive to DENV-3 at study day 28 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||95|74|
72455557|NCT02678455|144434181|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|94.0|||||TWO_SIDED|95.0|81.0|98.0||||||Adolescent cohort: percent seropositive to DENV-3 at study day 56 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||98|81|
72455558|NCT02678455|144434181|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|97.0|||||TWO_SIDED|95.0|85.0|99.0||||||Adolescent cohort: percent seropositive to DENV-3 at study day 180 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||99|85|
72455559|NCT02678455|144434181|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|89.0|||||TWO_SIDED|95.0|74.0|95.0||||||Adolescent cohort: percent seropositive to DENV-3 at study day 360 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||95|74|
72392064|NCT05426902|144291510|SUPERIORITY|||||||1|||||||t-test, 2 sided|||"SLE@Duke is appealing to me at baseline (month 1) vs. intervention period (month 2)."||||1.0
72455560|NCT02678455|144434181|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|57.0|||||TWO_SIDED|95.0|41.0|72.0||||||Adolescent cohort: percent seropositive to DENV-3 at study day 720 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||72|41|
72455561|NCT02678455|144434181|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|57.0|||||TWO_SIDED|95.0|41.0|72.0||||||Adolescent cohort: percent seropositive to DENV-3 at study day 1080 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||72|41|
72455562|NCT02678455|144434181|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|0.0|||||TWO_SIDED|95.0|0.0|10.0||||||Adolescent cohort: percent seropositive to DENV-4 at study day 0 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||10|0|
72455563|NCT02678455|144434181|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|83.0|||||TWO_SIDED|95.0|67.0|92.0||||||Adolescent cohort: percent seropositive to DENV-4 at study day 28 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||92|67|
72455564|NCT02678455|144434181|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|77.0|||||TWO_SIDED|95.0|61.0|88.0||||||Adolescent cohort: percent seropositive to DENV-4 at study day 56 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||88|61|
72392065|NCT05426902|144291510|SUPERIORITY|||||||0.5|||||||t-test, 2 sided|||"I like SLE@Duke at baseline (month 1) vs. intervention period (month 2)."||||0.5
72500065|NCT04696861|144530172|SUPERIORITY|||||||0.961||||||Unitized unadjusted bivariate analyses instead of adjusted multivariable analysis. This was a pilot study to estimate the magnitude of effect sizes for informing further large interventions. The significance level was also not adjusted.|Mixed Models Analysis|||Generalized linear mixed models were conducted and odds ratios (ORs) were reported||||0.961
72500066|NCT04696861|144530173|SUPERIORITY|||||||0.961||||||Unitized unadjusted bivariate analyses instead of adjusted multivariable analysis. This was a pilot study to estimate the magnitude of effect sizes for informing further large interventions. The significance level was also not adjusted.|Mixed Models Analysis|||Generalized linear mixed models were conducted and odds ratios (ORs) were reported||||0.961
72562881|NCT01546519|144657489|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.24|||||TWO_SIDED|90.0|0.9|1.71||||||Css Mild HI vs. Normal: Based on pooled variance estimates||1.71|0.90|
72392066|NCT05426902|144291510|SUPERIORITY|||||||0.6|||||||t-test, 2 sided|||"I welcome SLE@Duke at baseline (month 1) vs. intervention period (month 2)."||||0.6
72392067|NCT05426902|144291511|SUPERIORITY|||||||0.7|||||||t-test, 2 sided|||"SLE@Duke seems fitting at baseline (month 1) vs. intervention period (month 2)."||||0.7
72392068|NCT05426902|144291511|SUPERIORITY|||||||0.7|||||||t-test, 2 sided|||"SLE@Duke seems suitable at baseline (month 1) vs. intervention period (month 2)."||||0.7
72392069|NCT05426902|144291511|SUPERIORITY|||||||1|||||||t-test, 2 sided|||"SLE@Duke seems applicable at baseline (month 1) vs. intervention period (month 2)."||||1.0
72392070|NCT05426902|144291511|SUPERIORITY|||||||1|||||||t-test, 2 sided|||"SLE@Duke seems like a good match at baseline (month 1) vs. intervention period (month 2)."||||1.0
72392071|NCT05426902|144291512|SUPERIORITY|||||||0.3|||||||t-test, 2 sided|||"SLE@Duke seems implementable at baseline (month 1) vs. intervention period (month 2)."||||0.3
72392072|NCT05426902|144291512|SUPERIORITY|||||||0.3|||||||t-test, 2 sided|||"SLE@Duke seems possible at baseline (month 1) vs. intervention period (month 2)."||||0.3
72392073|NCT05426902|144291512|SUPERIORITY|||||||0.4|||||||t-test, 2 sided|||"SLE@Duke seems doable at baseline (month 1) vs. intervention period (month 2)."||||0.4
72392074|NCT05426902|144291512|SUPERIORITY|||||||0.3|||||||t-test, 2 sided|||"SLE@Duke seems easy to use at baseline (month 1) vs. intervention period (month 2)."||||0.3
72392075|NCT02064894|144291515|SUPERIORITY_OR_OTHER|||||||0.81|||||||Cochran-Mantel-Haenszel|||||||0.81
72392076|NCT02864498|144291611|SUPERIORITY|||||||0.557|||||||General Linear Model|||||||0.5570
72392077|NCT02864498|144291611|SUPERIORITY|||||||0.8774|||||||General Linear Model|||||||0.8774
72392078|NCT04950998|144291616|SUPERIORITY||Mean Difference (Final Values)|604.07|STANDARD_DEVIATION|2560.36||0.376|TWO_SIDED|95.0|-813.815|2021.95|||t-test, 2 sided|||||2021.95|-813.815|0.376
72392079|NCT04950998|144291617|SUPERIORITY||Mean Difference (Final Values)|-35.019|STANDARD_DEVIATION|172.168||0.444|TWO_SIDED|95.0|-130.36|60.324|||t-test, 2 sided|||||60.324|-130.36|.444
72392080|NCT00601458|144291629|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-50.7||||0.005||97.8|-73.6|-8.0||1-sided alpha = 0.045 Hochberg closed testing procedure|ANOVA||The natural log scale treatment difference (pregabalin - placebo) and 97.8% CI for the treatment difference were exponentiated and reported as a percentage reduction in 24-h cumulative hydromorphone consumption.|||-8.0|-73.6|0.005
72392081|NCT00601458|144291629|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-65.4||||0.0001||97.8|-81.7|-34.6||1-sided alpha = 0.045 Hochberg closed testing procedure|ANOVA||The natural log scale treatment difference (naproxen - placebo) and 97.8% CI for the treatment difference were exponentiated and reported as a percentage reduction in 24-h cumulative hydromorphone consumption.|||-34.6|-81.7|0.0001
72392082|NCT00601458|144291630|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|1.46||||0.004||95.0|0.183|2.95||1-sided alpha = 0.045 Hochberg closed testing procedure|Log Rank||Hodges-Lehmann procedure was used to obtain an estimate of the difference in medians and an exact CI for the difference in medians|||2.95|0.183|0.004
72392083|NCT00601458|144291630|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|3.7|||<|0.001||95.0|1.77|6.72||1-sided alpha = 0.045 Hochberg closed testing procedure|Log Rank||Hodges-Lehmann procedure was used to obtain an estimate of the difference in medians and an exact CI for the difference in medians|||6.72|1.77|<0.001
72392084|NCT02557555|144291645|OTHER|P-values corresponding to a test of equal proportions (yes/no- 50%/50%)|||||<|0.0001||||||Researched options for labor pain|Test of equal proportion (50/50)|||||||<0.0001
72392085|NCT02557555|144291645|OTHER|P-values corresponding to a test of equal proportions (yes/no- 50%/50%)|||||<|0.0001||||||Pamphlet better explained options for pain|Test of equal proportion (50/50)|||||||<0.0001
72392086|NCT02557555|144291645|OTHER||||||<|0.0001||||||Pamphlet should be given before onset labor pain|Test of equal proportion (50/50)|||||||<0.0001
72392087|NCT02557555|144291645|OTHER||||||<|0.0001||||||Pamphlet information helped to reduce anxiety|Test of equal proportion (50/50)|||||||<0.0001
72392088|NCT02557555|144291645|OTHER|||||||0.0002||||||Information corrected any misconception|Test of equal proportion (50/50)|||||||0.0002
72392089|NCT02557555|144291645|OTHER||||||<|0.0001||||||Written information should always be available|Test of equal proportion (50/50)|||||||<0.0001
72392090|NCT03129100|144291651|SUPERIORITY||Odds Ratio (OR)|4.35|||<|0.001|TWO_SIDED|95.0|2.03|9.35|||Regression, Logistic|||||9.35|2.03|<0.001
72392091|NCT03129100|144291652|SUPERIORITY||Odds Ratio (OR)|4.28||||0.003|TWO_SIDED|95.0|1.66|11.03|||Regression, Logistic|||||11.03|1.66|0.003
72392092|NCT03129100|144291652|SUPERIORITY||Odds Ratio (OR)|4.42||||0.001|TWO_SIDED|95.0|1.77|11.02|||Regression, Logistic|||||11.02|1.77|0.001
72392093|NCT03129100|144291654|SUPERIORITY||Odds Ratio (OR)|4.51||||0.001|TWO_SIDED|95.0|1.78|11.41|||Regression, Logistic|||||11.41|1.78|0.001
72392094|NCT03129100|144291654|SUPERIORITY||Odds Ratio (OR)|4.61|||<|0.001|TWO_SIDED|95.0|1.88|11.31|||Regression, Logistic|||||11.31|1.88|<0.001
72392095|NCT03129100|144291655|SUPERIORITY||Odds Ratio (OR)|5.17|||<|0.001|TWO_SIDED|95.0|2.11|12.69|||Regression, Logistic|||||12.69|2.11|<0.001
72392096|NCT03129100|144291655|SUPERIORITY||Odds Ratio (OR)|5.23|||<|0.001|TWO_SIDED|95.0|2.2|12.47|||Regression, Logistic|||||12.47|2.20|<0.001
72392097|NCT03129100|144291656|SUPERIORITY||Odds Ratio (OR)|4.6|||<|0.001|TWO_SIDED|95.0|1.9|11.17|||Regression, Logistic|||||11.17|1.90|<0.001
72562882|NCT01546519|144657489|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.27|||||TWO_SIDED|90.0|0.89|1.8||||||Css Moderate HI vs. Normal: Based on pooled variance estimates||1.80|0.89|
72392098|NCT03129100|144291656|SUPERIORITY||Odds Ratio (OR)|3.55||||0.003|TWO_SIDED|95.0|1.56|8.09|||Regression, Logistic|||||8.09|1.56|0.003
72392099|NCT03129100|144291657|SUPERIORITY||Odds Ratio (OR)|4.92|||<|0.001|TWO_SIDED|95.0|2.07|11.72|||Regression, Logistic|||||11.72|2.07|<0.001
72392100|NCT03129100|144291657|SUPERIORITY||Odds Ratio (OR)|3.61||||0.003|TWO_SIDED|95.0|1.57|8.32|||Regression, Logistic|||||8.32|1.57|0.003
72392101|NCT03129100|144291658|SUPERIORITY||LS Mean Difference|-2.1|STANDARD_ERROR_OF_MEAN|0.51|<|0.001|TWO_SIDED|95.0|-3.1|-1.1|||ANCOVA|||Patient Global||-1.1|-3.1|<0.001
72392102|NCT03129100|144291658|SUPERIORITY||LS Mean Difference|-2.0|STANDARD_ERROR_OF_MEAN|0.49|<|0.001|TWO_SIDED|95.0|-2.9|-1.0|||ANCOVA|||Patient Global||-1.0|-2.9|<0.001
72392103|NCT03129100|144291658|SUPERIORITY||LS Mean Difference|-2.1|STANDARD_ERROR_OF_MEAN|0.51|<|0.001|TWO_SIDED|95.0|-3.1|-1.0|||ANCOVA|||Spinal Pain||-1.0|-3.1|<0.001
72392104|NCT03129100|144291658|SUPERIORITY||LS Mean Difference|-1.8|STANDARD_ERROR_OF_MEAN|0.49|<|0.001|TWO_SIDED|95.0|-2.8|-0.8|||ANCOVA|||Spinal Pain||-0.8|-2.8|<0.001
72392105|NCT03129100|144291658|SUPERIORITY||LS Mean Difference|-1.55|STANDARD_ERROR_OF_MEAN|0.421|<|0.001|TWO_SIDED|95.0|-2.39|-0.72|||ANCOVA|||BASFI||-0.72|-2.39|<0.001
72392106|NCT03129100|144291658|SUPERIORITY||LS Mean Difference|-1.4|STANDARD_ERROR_OF_MEAN|0.409|<|0.001|TWO_SIDED|95.0|-2.2|-0.59|||ANCOVA|||BASFI||-0.59|-2.20|<0.001
72392107|NCT03129100|144291658|SUPERIORITY||LS Mean Difference|-2.17|STANDARD_ERROR_OF_MEAN|0.448|<|0.001|TWO_SIDED|95.0|-3.05|-1.28|||ANCOVA|||Inflammation||-1.28|-3.05|<0.001
72392108|NCT03129100|144291658|SUPERIORITY||LS Mean Difference|-1.8|STANDARD_ERROR_OF_MEAN|0.433|<|0.001|TWO_SIDED|95.0|-2.66|-0.95|||ANCOVA|||Inflammation||-0.95|-2.66|<0.001
72392109|NCT03129100|144291659|SUPERIORITY||Odds Ratio (OR)|5.34|||<|0.001|TWO_SIDED|95.0|2.13|13.35|||Regression, Logistic|||||13.35|2.13|<0.001
72392110|NCT03129100|144291659|SUPERIORITY||Odds Ratio (OR)|4.07||||0.001|TWO_SIDED|95.0|1.75|9.45|||Regression, Logistic|||||9.45|1.75|0.001
72392111|NCT03129100|144291660|SUPERIORITY||LS Mean Difference|-7.858|STANDARD_ERROR_OF_MEAN|1.9586|<|0.001|TWO_SIDED|95.0|-11.729|-3.987|||ANCOVA|||||-3.987|-11.729|<0.001
72392112|NCT03129100|144291660|SUPERIORITY||LS Mean Difference|-5.979|STANDARD_ERROR_OF_MEAN|1.86||0.002|TWO_SIDED|95.0|-9.655|-2.304|||ANCOVA|||||-2.304|-9.655|0.002
72392113|NCT03129100|144291661|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.104||0.062|TWO_SIDED|95.0|-0.4|0.01|||ANCOVA|||||0.01|-0.40|0.062
72392114|NCT03129100|144291661|SUPERIORITY||LS Mean Difference|-0.24|STANDARD_ERROR_OF_MEAN|0.099||0.018|TWO_SIDED|95.0|-0.43|-0.04|||ANCOVA|||||-0.04|-0.43|0.018
72392115|NCT03129100|144291662|SUPERIORITY||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.335||0.757|TWO_SIDED|95.0|-0.56|0.77|||ANCOVA|||||0.77|-0.56|0.757
72392116|NCT03129100|144291662|SUPERIORITY||LS Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.322||0.67|TWO_SIDED|95.0|-0.77|0.5|||ANCOVA|||||0.50|-0.77|0.670
72392117|NCT03129100|144291663|SUPERIORITY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.338||0.236|TWO_SIDED|95.0|-1.07|0.27|||ANCOVA|||||0.27|-1.07|0.236
72392118|NCT03129100|144291663|SUPERIORITY||LS Mean Difference|-0.28|STANDARD_ERROR_OF_MEAN|0.319||0.373|TWO_SIDED|95.0|-0.92|0.35|||ANCOVA|||||0.35|-0.92|0.373
72392119|NCT03129100|144291664|SUPERIORITY||LS Mean Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.459||0.885|TWO_SIDED|95.0|-0.98|0.85|||ANCOVA|||||0.85|-0.98|0.885
72392120|NCT03129100|144291664|SUPERIORITY||LS Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.41||0.735|TWO_SIDED|95.0|-0.95|0.68|||ANCOVA|||||0.68|-0.95|0.735
72392121|NCT03129100|144291665|SUPERIORITY||LS Mean Difference|-0.53|STANDARD_ERROR_OF_MEAN|0.501||0.294|TWO_SIDED|95.0|-1.53|0.47|||ANCOVA|||||0.47|-1.53|0.294
72392122|NCT03129100|144291665|SUPERIORITY||LS Mean Difference|-0.64|STANDARD_ERROR_OF_MEAN|0.453||0.164|TWO_SIDED|95.0|-1.54|0.27|||ANCOVA|||||0.27|-1.54|0.164
72392123|NCT03129100|144291666|SUPERIORITY||LS Mean Difference|-2.1|STANDARD_ERROR_OF_MEAN|1.1||0.063|TWO_SIDED|95.0|-4.3|0.1|||ANCOVA|||||0.1|-4.3|0.063
72392124|NCT03129100|144291666|SUPERIORITY||LS Mean Difference|-1.3|STANDARD_ERROR_OF_MEAN|1.02||0.211|TWO_SIDED|95.0|-3.3|0.7|||ANCOVA|||||0.7|-3.3|0.211
72392125|NCT03129100|144291667|SUPERIORITY||LS Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|0.9||0.334|TWO_SIDED|95.0|-2.7|0.9|||ANCOVA|||||0.9|-2.7|0.334
72392126|NCT03129100|144291667|SUPERIORITY||LS Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|0.88||0.168|TWO_SIDED|95.0|-3.0|0.5|||ANCOVA|||||0.5|-3.0|0.168
72392127|NCT03129100|144291669|SUPERIORITY||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.4||0.1|TWO_SIDED|95.0|-1.5|0.1|||ANCOVA|||||0.1|-1.5|0.100
72392128|NCT03129100|144291669|SUPERIORITY||LS Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.38||0.047|TWO_SIDED|95.0|-1.5|0.0|||ANCOVA|||||-0.0|-1.5|0.047
72392129|NCT03129100|144291670|SUPERIORITY||LS Mean Difference|-0.88|STANDARD_ERROR_OF_MEAN|0.479||0.068|TWO_SIDED|95.0|-1.83|0.06|||ANCOVA|||||0.06|-1.83|0.068
72392130|NCT03129100|144291670|SUPERIORITY||LS Mean Difference|-0.48|STANDARD_ERROR_OF_MEAN|0.465||0.307|TWO_SIDED|95.0|-1.4|0.44|||ANCOVA|||||0.44|-1.40|0.307
72392131|NCT03129100|144291671|SUPERIORITY||LS Mean Difference|2.6021|STANDARD_ERROR_OF_MEAN|1.4684||0.079|TWO_SIDED|95.0|-0.3011|5.5053|||ANCOVA|||||5.5053|-0.3011|0.079
72392132|NCT03129100|144291671|SUPERIORITY||LS Mean Difference|2.4096|STANDARD_ERROR_OF_MEAN|1.3978||0.087|TWO_SIDED|95.0|-0.3541|5.1734|||ANCOVA|||||5.1734|-0.3541|0.087
72392133|NCT03129100|144291672|SUPERIORITY||LS Mean Difference|0.837|STANDARD_ERROR_OF_MEAN|1.1752||0.477|TWO_SIDED|95.0|-1.4864|3.1605|||ANCOVA|||||3.1605|-1.4864|0.477
72392134|NCT03129100|144291672|SUPERIORITY||LS Mean Difference|2.3009|STANDARD_ERROR_OF_MEAN|1.1192||0.042|TWO_SIDED|95.0|0.088|4.5138|||ANCOVA|||||4.5138|0.0880|0.042
72392135|NCT03129100|144291673|SUPERIORITY||LS Mean Difference|-0.99|STANDARD_ERROR_OF_MEAN|0.52||0.058|TWO_SIDED|95.0|-2.02|0.04|||ANCOVA|||||0.04|-2.02|0.058
72392136|NCT03129100|144291673|SUPERIORITY||LS Mean Difference|-0.72|STANDARD_ERROR_OF_MEAN|0.497||0.147|TWO_SIDED|95.0|-1.71|0.26|||ANCOVA|||||0.26|-1.71|0.147
72392137|NCT03129100|144291674|SUPERIORITY||LS Mean Difference|0.0418|STANDARD_ERROR_OF_MEAN|0.0334||0.213|TWO_SIDED|95.0|-0.0329|0.1164|||ANCOVA|||||0.1164|-0.0329|0.213
72392138|NCT03129100|144291674|SUPERIORITY||LS Mean Difference|0.0388|STANDARD_ERROR_OF_MEAN|0.0319||0.225|TWO_SIDED|95.0|-0.0324|0.1101|||ANCOVA|||||0.1101|-0.0324|0.225
72392139|NCT03129100|144291675|SUPERIORITY||LS Mean Difference|-10.62|STANDARD_ERROR_OF_MEAN|4.383||0.017|TWO_SIDED|95.0|-19.28|-1.95|||ANCOVA|||Percentage of Activity Impairment||-1.95|-19.28|0.017
72500067|NCT04696861|144530174|SUPERIORITY|||||||0.368||||||Unitized unadjusted bivariate analyses instead of adjusted multivariable analysis. This was a pilot study to estimate the magnitude of effect sizes for informing further large interventions. The significance level was also not adjusted.|Mixed Models Analysis|||Generalized linear mixed models were conducted and odds ratios (ORs) were reported||||0.368
72500068|NCT04696861|144530176|SUPERIORITY|||||||0.634||||||Unitized unadjusted bivariate analyses instead of adjusted multivariable analysis. This was a pilot study to estimate the magnitude of effect sizes for informing further large interventions. The significance level was also not adjusted.|Mixed Models Analysis|||General linear mixed models||||0.634
72500069|NCT04696861|144530177|SUPERIORITY|||||||0.832||||||Unitized unadjusted bivariate analyses instead of adjusted multivariable analysis. This was a pilot study to estimate the magnitude of effect sizes for informing further large interventions. The significance level was also not adjusted.|Mixed Models Analysis|||General linear mixed models||||0.832
72500070|NCT04696861|144530179|SUPERIORITY|||||||0.624||||||Unitized unadjusted bivariate analyses instead of adjusted multivariable analysis. This was a pilot study to estimate the magnitude of effect sizes for informing further large interventions. The significance level was also not adjusted.|Mixed Models Analysis|||Generalized linear mixed models were conducted and odds ratios (ORs) were reported||||0.624
72500071|NCT04696861|144530180|SUPERIORITY|||||||0.833||||||Unitized unadjusted bivariate analyses instead of adjusted multivariable analysis. This was a pilot study to estimate the magnitude of effect sizes for informing further large interventions. The significance level was also not adjusted.|Mixed Models Analysis|||General linear mixed models||||0.833
72500072|NCT04696861|144530181|SUPERIORITY|||||||0.7||||||Unitized unadjusted bivariate analyses instead of adjusted multivariable analysis. This was a pilot study to estimate the magnitude of effect sizes for informing further large interventions. The significance level was also not adjusted.|Mixed Models Analysis|||General linear mixed models||||0.7
72500073|NCT04696861|144530182|SUPERIORITY|||||||0.79||||||Unitized unadjusted bivariate analyses instead of adjusted multivariable analysis. This was a pilot study to estimate the magnitude of effect sizes for informing further large interventions. The significance level was also not adjusted.|Mixed Models Analysis|||General linear mixed models||||0.79
72392140|NCT03129100|144291675|SUPERIORITY||LS Mean Difference|-7.14|STANDARD_ERROR_OF_MEAN|4.199||0.091|TWO_SIDED|95.0|-15.44|1.16|||ANCOVA|||Percentage of Activity Impairment||1.16|-15.44|0.091
72392141|NCT03129100|144291676|SUPERIORITY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.66||0.531|TWO_SIDED|95.0|-1.7|0.9|||ANCOVA|||||0.9|-1.7|0.531
72392142|NCT03129100|144291676|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.62||0.743|TWO_SIDED|95.0|-1.4|1.0|||ANCOVA|||||1.0|-1.4|0.743
72392143|NCT03789474|144291679|SUPERIORITY|||||||0.443|||||||t-test, 2 sided|||||||.443
72392144|NCT03789474|144291680|SUPERIORITY|||||||0.063|||||||t-test, 2 sided|||||||.063
72392145|NCT03789474|144291681|SUPERIORITY|||||||0.057|||||||t-test, 2 sided|||||||.057
72392146|NCT03789474|144291682|SUPERIORITY|||||||0.038|||||||t-test, 2 sided|||||||.038
72392147|NCT03789474|144291683|SUPERIORITY|||||||0.072|||||||t-test, 2 sided|||||||.072
72392148|NCT03789474|144291684|SUPERIORITY|||||||0.189|||||||t-test, 2 sided|||||||.189
72392149|NCT03789474|144291685|SUPERIORITY|||||||0.358|||||||t-test, 2 sided|||||||.358
72392150|NCT03789474|144291686|SUPERIORITY|||||||0.406|||||||t-test, 2 sided|||||||.406
72500074|NCT04696861|144530183|SUPERIORITY|||||||0.55||||||Unitized unadjusted bivariate analyses instead of adjusted multivariable analysis. This was a pilot study to estimate the magnitude of effect sizes for informing further large interventions. The significance level was also not adjusted.|Mixed Models Analysis|||General linear mixed models||||0.55
72392151|NCT03789474|144291687|SUPERIORITY|||||||0.256|||||||t-test, 2 sided|||||||.256
72392152|NCT03789474|144291688|SUPERIORITY|||||||0.066|||||||t-test, 2 sided|||||||.066
72392153|NCT03789474|144291689|SUPERIORITY|||||||0.316|||||||t-test, 2 sided|||||||.316
72392154|NCT03789474|144291690|SUPERIORITY|||||||0.971|||||||t-test, 2 sided|||||||.971
72392155|NCT03789474|144291691|SUPERIORITY|||||||0.03|||||||t-test, 2 sided|||||||.030
72392156|NCT03789474|144291692|SUPERIORITY|||||||0.009|||||||t-test, 2 sided|||||||.009
72392157|NCT03789474|144291693|SUPERIORITY|||||||0.704|||||||t-test, 2 sided|||||||.704
72392158|NCT03789474|144291694|SUPERIORITY|||||||0.35|||||||t-test, 2 sided|||||||.350
72392159|NCT03789474|144291695|SUPERIORITY|||||||0.708|||||||t-test, 2 sided|||||||.708
72392160|NCT03789474|144291696|SUPERIORITY|||||||0.711|||||||t-test, 2 sided|||||||.711
72392161|NCT03789474|144291697|SUPERIORITY|||||||0.956|||||||t-test, 2 sided|||||||.956
72392162|NCT03789474|144291698|SUPERIORITY|||||||0.139|||||||t-test, 2 sided|||||||.139
72392163|NCT03789474|144291699|SUPERIORITY|||||||0.035|||||||t-test, 2 sided|||||||.035
72392164|NCT03789474|144291700|SUPERIORITY|||||||0.502|||||||t-test, 2 sided|||||||.502
72392165|NCT03789474|144291701|SUPERIORITY|||||||0.35|||||||t-test, 2 sided|||||||.350
72392166|NCT03789474|144291702|SUPERIORITY|||||||0.38|||||||t-test, 2 sided|||||||.380
72392167|NCT03789474|144291703|SUPERIORITY|||||||0.914|||||||t-test, 2 sided|||||||.914
72392168|NCT03789474|144291704|SUPERIORITY|||||||0.915|||||||t-test, 2 sided|||||||.915
72392169|NCT03789474|144291705|SUPERIORITY|||||||0.087|||||||t-test, 2 sided|||||||.087
72392170|NCT03789474|144291706|SUPERIORITY|||||||0.011|||||||t-test, 2 sided|||||||.011
72500075|NCT04696861|144530184|SUPERIORITY|||||||0.823|||||||Mixed Models Analysis|||||||.823
72500076|NCT04696861|144530185|SUPERIORITY|||||||0.942|||||||Mixed Models Analysis|||||||.942
72500077|NCT04696861|144530186|SUPERIORITY|||||||0.207||||||Unitized unadjusted bivariate analyses instead of adjusted multivariable analysis. This was a pilot study to estimate the magnitude of effect sizes for informing further large interventions. The significance level was also not adjusted.|Mixed Models Analysis|||General linear mixed models||||0.207
72500078|NCT04696861|144530187|SUPERIORITY|||||||0.594||||||Unitized unadjusted bivariate analyses instead of adjusted multivariable analysis. This was a pilot study to estimate the magnitude of effect sizes for informing further large interventions. The significance level was also not adjusted.|Mixed Models Analysis|||General linear mixed models||||0.594
72500079|NCT04696861|144530188|SUPERIORITY|||||||0.738||||||Unitized unadjusted bivariate analyses instead of adjusted multivariable analysis. This was a pilot study to estimate the magnitude of effect sizes for informing further large interventions. The significance level was also not adjusted.|Mixed Models Analysis|||General linear mixed models||||0.738
72392171|NCT03789474|144291707|SUPERIORITY|||||||0.207|||||||t-test, 2 sided|||||||.207
72392172|NCT03789474|144291708|SUPERIORITY|||||||0.142|||||||t-test, 2 sided|||||||.142
72392173|NCT03789474|144291709|SUPERIORITY|||||||0.021|||||||t-test, 2 sided|||||||.021
72392174|NCT03789474|144291710|SUPERIORITY|||||||0.0001|||||||t-test, 2 sided|||||||0.0001
72392175|NCT03789474|144291711|SUPERIORITY|||||||0.03|||||||t-test, 2 sided|||||||.030
72392176|NCT03789474|144291712|SUPERIORITY|||||||0.048|||||||t-test, 2 sided|||||||.048
72392177|NCT03789474|144291713|SUPERIORITY|||||||0.047|||||||t-test, 2 sided|||||||.047
72392178|NCT03789474|144291714|SUPERIORITY|||||||0.019|||||||t-test, 2 sided|||||||.019
72392179|NCT03789474|144291715|SUPERIORITY|||||||0|||||||t-test, 2 sided|||||||.000
72392180|NCT03789474|144291716|SUPERIORITY|||||||0.004|||||||t-test, 2 sided|||||||.004
72392181|NCT03789474|144291717|SUPERIORITY|||||||0.02|||||||t-test, 2 sided|||||||.020
72392182|NCT03789474|144291718|SUPERIORITY|||||||0|||||||t-test, 2 sided|||||||.000
72392183|NCT03789474|144291719|SUPERIORITY|||||||0.053|||||||t-test, 2 sided|||||||.053
72392184|NCT03789474|144291720|SUPERIORITY|||||||0.746|||||||t-test, 2 sided|||||||.746
72392185|NCT03789474|144291721|SUPERIORITY|||||||0.006|||||||t-test, 2 sided|||||||.006
72392186|NCT03789474|144291722|SUPERIORITY|||||||0.003|||||||t-test, 2 sided|||||||.003
72392187|NCT03789474|144291723|SUPERIORITY|||||||0.043|TWO_SIDED|95.0|||||t-test, 2 sided|||||||0.043
72392188|NCT03789474|144291724|SUPERIORITY|||||||0.16|||||||t-test, 2 sided|||||||.160
72392189|NCT01269463|144291782|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.01|TWO_SIDED||||||ANCOVA|||||||<0.01
72392190|NCT01269463|144291783|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.01|TWO_SIDED||||||ANCOVA|||||||<0.01
72392191|NCT04404361|144291793|SUPERIORITY||Risk Difference (RD)|1.51||||0.8516|TWO_SIDED|95.0|-10.55|13.53|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by age (\<60 years versus ≥60 years) and 7-point clinical status scale (baseline 3 or 4 versus 5).||||13.53|-10.55|0.8516
72392192|NCT04404361|144291794|SUPERIORITY|||||||0.7494|||||||Wilcoxon (Mann-Whitney)|||||||0.7494
72392193|NCT04404361|144291795|SUPERIORITY||Odds Ratio (OR)|1.29||||0.6323|TWO_SIDED|95.0|0.46|3.58|||Cochran-Mantel-Haenszel||OR from a CMH test stratified by randomization stratification factors age (\<60 years versus ≥60 years) and 7-point clinical status scale (baseline 3 or 4 versus 5) as entered in the IXRS|||3.58|0.46|0.6323
72392194|NCT04404361|144291796|SUPERIORITY||Odds Ratio (OR)|1.25||||0.7541|TWO_SIDED|95.0|0.31|4.96|||Cochran-Mantel-Haenszel||OR from a CMH test Stratified by randomization stratification factors age (\<60 years versus ≥60 years) and 7-point clinical status scale (baseline 3 or 4 versus 5) as entered in the IXRS|||4.96|0.31|0.7541
72392195|NCT04404361|144291797|SUPERIORITY||Hazard Ratio (HR)|1.09||||0.5666|TWO_SIDED|95.0|0.79|1.53||"log-rank test stratified by randomization stratification factors age (\<60 years versus~≥60 years) and 7-point clinical status scale (baseline 3 or 4 versus 5) as entered in the IXRS"|Log Rank|"stratified by randomization stratification factors age (\<60 years versus~≥60 years) and 7-point clinical status scale (baseline 3 or 4 versus 5)"|estimated using a stratified Cox proportional hazards model stratified by randomization stratification factors age (\<60 years versus ≥60 years) and 7-point clinical status scale (baseline 3 or 4 versus 5)|||1.53|0.79|0.5666
72392196|NCT04404361|144291799|SUPERIORITY||Odds Ratio (OR)|2.46||||0.2722|TWO_SIDED|95.0|0.47|12.93|||Chi-squared|||||12.93|0.47|0.2722
72392197|NCT01125605|144291805|SUPERIORITY_OR_OTHER|||||||0.0033||95.0|||||ANCOVA|ANCOVA with GLM (Generalized Linear Model) of SAS® (with type III sums of squares); including the baseline value of the sum score as a covariate||decrease of the sum score between baseline (visit 1) and last observation was exploratively analysed||||0.0033
72392198|NCT01125605|144291805|SUPERIORITY_OR_OTHER|||||||0.0002||95.0|||||ANCOVA|ANCOVA with GLM (Generalized Linear Model) of SAS® (with type III sums of squares); including the baseline value of the sum score as a covariate||decrease of the sum score between baseline (visit1) and last observation by duration of treatment||||0.0002
72392199|NCT01125605|144291806|SUPERIORITY_OR_OTHER|||||||0.0014||95.0|||||Fisher Exact|||||||0.0014
72392200|NCT01125605|144291807|SUPERIORITY_OR_OTHER|||||||0.0125||95.0|||||Fisher Exact|||||||0.0125
72392201|NCT01125605|144291808|SUPERIORITY_OR_OTHER|||||||0.0006||95.0|||||Fisher Exact|||||||0.0006
72392202|NCT01125605|144291809|SUPERIORITY_OR_OTHER|||||||0.0016||95.0|||||Fisher Exact|||||||0.0016
72392203|NCT01125605|144291810|SUPERIORITY_OR_OTHER|||||||0.0504||95.0|||||Fisher Exact|||||||0.0504
72392204|NCT01125605|144291812|SUPERIORITY_OR_OTHER|||||||0.0002||95.0|||||Fisher Exact|||||||0.0002
72392205|NCT05405309|144291888|OTHER||||||||||||||||||"The primary analysis was of safety and included all patients who received at least one dose of the investigational regimen. The rate of adverse events was estimated after the first 5 patients were treated at Original DL1 (camonsertib 40mg daily and olaparib 100mg BID dosing 2 days per week, at 28 day cycles)~After the first 5 patients were treated, it was determined that this dosing strategy may not be appropriate for R/R CLL patients and reduced dosing frequency may be necessary to increase the safety of the combination therapy. The protocol and DLs were amended, and sought to enroll an additional 18 patients.~Before the enrollment of 18 additional participants and MTD determination, the study was terminated due to sponsor de-activation of all programs associated with camonsertib."|||
72392206|NCT05425745|144291908|SUPERIORITY||Least Squares (LS) Means|-36.31|STANDARD_ERROR_OF_MEAN|3.019|<|0.0001|TWO_SIDED|95.0|-42.22|-30.39|||ANCOVA|||||-30.39|-42.22|<.0001
72392207|NCT05425745|144291909|SUPERIORITY||Least Squares (LS) Means|-37.78|STANDARD_ERROR_OF_MEAN|3.572|<|0.0001|TWO_SIDED|95.0|-44.79|-30.78|||ANCOVA|||||-30.78|-44.79|<.0001
72562883|NCT01546519|144657489|SUPERIORITY_OR_OTHER||Geometric mean ratio|0.88|||||TWO_SIDED|90.0|0.55|1.41||||||Css Severe HI vs. Normal: Based on pooled variance estimates||1.41|0.55|
72562884|NCT01546519|144657490|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.24|||||TWO_SIDED|90.0|0.89|1.73||||||AUC0-24hr Mild HI vs. Normal: Based on pooled variance estimates||1.73|0.89|
72562885|NCT01546519|144657490|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.31|||||TWO_SIDED|90.0|0.91|1.89||||||AUC0-24hr Moderate HI vs. Normal: Based on pooled variance estimates||1.89|0.91|
72562886|NCT01546519|144657490|SUPERIORITY_OR_OTHER||Geometric mean ratio|0.86|||||TWO_SIDED|90.0|0.53|1.39||||||AUC0-24hr Severe HI vs. Normal: Based on pooled variance estimates||1.39|0.53|
72562887|NCT02958319|144657498|SUPERIORITY||Median Difference (Final Values)|4.1||||0.82|TWO_SIDED|||||p \< 0.05 was considered statistically significant|GENERAL LINEAL MODEL|GENERAL LINEAL MODEL OF REPEATED MEASURES||||||0.82
72455565|NCT02678455|144434181|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|71.0|||||TWO_SIDED|95.0|55.0|84.0||||||Adolescent cohort: percent seropositive to DENV-4 at study day 180 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||84|55|
72455566|NCT02678455|144434181|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|66.0|||||TWO_SIDED|95.0|49.0|79.0||||||Adolescent cohort: percent seropositive to DENV-4 at study day 360 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||79|49|
72455567|NCT02678455|144434181|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|60.0|||||TWO_SIDED|95.0|44.0|74.0||||||Adolescent cohort: percent seropositive to DENV-4 at study day 720 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||74|44|
72455568|NCT02678455|144434181|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|43.0|||||TWO_SIDED|95.0|28.0|59.0||||||Adolescent cohort: percent seropositive to DENV-4 at study day 1080 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||59|28|
72455569|NCT02678455|144434181|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|31.0|||||TWO_SIDED|95.0|18.0|47.0||||||Children cohort: percent seropositive to DENV-1 at study day 0 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||47|18|
72455570|NCT02678455|144434181|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|69.0|||||TWO_SIDED|95.0|53.0|82.0||||||Children cohort: percent seropositive to DENV-1 at study day 28 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||82|53|
72392208|NCT05425745|144291910|SUPERIORITY||Least Squares (LS) Means|-41.45|STANDARD_ERROR_OF_MEAN|4.938|<|0.0001|TWO_SIDED|95.0|-51.14|-31.76||The hierarchical testing procedure would only be conducted if the previous secondary efficacy endpoint reached a statistically significant treatment effect at p-value\<0.05|ANCOVA|||||-31.76|-51.14|<.0001
72455571|NCT02678455|144434181|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|61.0|||||TWO_SIDED|95.0|45.0|75.0||||||Children cohort: percent seropositive to DENV-1 at study day 56 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||75|45|
72500080|NCT04696861|144530189|SUPERIORITY|||||||0.845||||||Unitized unadjusted bivariate analyses instead of adjusted multivariable analysis. This was a pilot study to estimate the magnitude of effect sizes for informing further large interventions. The significance level was also not adjusted.|Mixed Models Analysis|||General linear mixed models||||0.845
72500081|NCT02382133|144530198|SUPERIORITY|comparing nasal and forehead oximetry sensor pressure ulcer incidence|||||=|0.006|||||||Chi-squared|||||||=.006
72500082|NCT00655928|144530199|SUPERIORITY|||||||0.09|||||||t-test, 2 sided|||||||0.09
72500083|NCT01976806|144530229|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.29|STANDARD_ERROR_OF_MEAN|0.13|<|0.05|||||||Mixed Models Analysis|Compound-symmetry covariance structure with age, sex, BMI, race, baseline pocket depth, baseline RBC DHA level, and intervention group variables|Mean change in pocket depth (3-month follow-up minus baseline) among dental sites with baseline pocket depths \>=5 mm in the DHA intervention group versus the placebo group.|Intent-to-treat basis with a type I error rate of 0.05. The follow-up pocket depth, was assessed in linear mixed effects models with a compound-symmetry covariance structure and age, sex, BMI, race, baseline pocket depth, baseline red blood cell (RBC) DHA level (dichotomized at median), and intervention group as fixed-effect variables.||||<0.05
72500084|NCT03896581|144530286|SUPERIORITY||Odds Ratio (OR)|11.139|||<|0.001|TWO_SIDED|95.0|5.402|22.969|||Regression, Logistic|||||22.969|5.402|<0.001
72500085|NCT03896581|144530287|SUPERIORITY||Least square (LS) mean difference|-0.326|||<|0.001|TWO_SIDED|95.0|-0.42|-0.233|||ANCOVA|||||-0.233|-0.420|<0.001
72620668|NCT02037984|144772324|OTHER|PT9V Percentage Point Difference (V114 - Prevnar 13®)|PT9V Percentage Point Difference|-3.4|||||TWO_SIDED|95.0|-17.3|6.3|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||6.3|-17.3|
72392209|NCT05425745|144291911|SUPERIORITY||Least Squares (LS) Means|-24.39|STANDARD_ERROR_OF_MEAN|2.136|<|0.0001|TWO_SIDED|95.0|-28.58|-20.2||The hierarchical testing procedure would only be conducted if the previous secondary efficacy endpoint reached a statistically significant treatment effect at p-value\<0.05|ANCOVA|||||-20.20|-28.58|<.0001
72455572|NCT02678455|144434181|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|56.0|||||TWO_SIDED|95.0|40.0|70.0||||||Children cohort: percent seropositive to DENV-1 at study day 180 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||70|40|
72500086|NCT03896581|144530289|SUPERIORITY||Odds Ratio (OR)|30.237|||<|0.001|TWO_SIDED|95.0|12.365|73.94|||Regression, Logistic|||||73.940|12.365|<0.001
72500087|NCT03896581|144530290|SUPERIORITY||LS mean difference|6.037|||<|0.001|TWO_SIDED|95.0|4.386|7.688|||ANCOVA|||||7.688|4.386|<0.001
72500088|NCT03896581|144530291|SUPERIORITY||Odds Ratio (OR)|13.089|||<|0.001|TWO_SIDED|95.0|6.119|27.999|||Regression, Logistic|||||27.999|6.119|<0.001
72500089|NCT03797001|144530311|SUPERIORITY|||||||0.6|||||||t-test, 2 sided|||||||0.60
72500090|NCT00215150|144530361|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|95.0|||||Wilcoxon Signed Rank Test|||Results are from a Wilcoxon signed rank test on the difference from endpoint to baseline for the intent to treat sample from the open label phase of the project.||||< 0.001
72500091|NCT00215150|144530361|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|95.0|||||Kruskal-Wallis|||Results are from a Kruskal Wallis test on the ziprasidone/placebo groups from the randomization phase of the project.||||> .05
72500092|NCT02091440|144530383|OTHER|Single group|Proportion|100.0|||||TWO_SIDED|95.0||||||||||||
72500093|NCT02091440|144530384|OTHER|Single group|Kaplan-Meier Survival|100.0|||||TWO_SIDED|||||||||||||
72500094|NCT02091440|144530385|OTHER|Single group|Incidence|1.24|||||TWO_SIDED|||||||||||||
72500095|NCT02091440|144530386|OTHER|Single group|Incidence|1.66|||||TWO_SIDED|||||||||||||
72620669|NCT02037984|144772324|OTHER|PT14 Percentage Point Difference (V114 - Prevnar 13®)|PT14 Percentage Point Difference|0.0|||||TWO_SIDED|95.0|-11.9|9.5|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||9.5|-11.9|
72620670|NCT02037984|144772324|OTHER|PT18C Percentage Point Difference (V114 - Prevnar 13®)|PT18C Percentage Point Difference|-3.4|||||TWO_SIDED|95.0|-17.3|6.3|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||6.3|-17.3|
72620671|NCT02037984|144772324|OTHER|PT19A Percentage Point Difference (V114 - Prevnar 13®)|PT19A Percentage Point Difference|-6.9|||||TWO_SIDED|95.0|-22.1|3.0|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||3.0|-22.1|
72620672|NCT02037984|144772324|OTHER|PT19F Percentage Point Difference (V114 - Prevnar 13®)|PT19F Percentage Point Difference|-3.4|||||TWO_SIDED|95.0|-17.3|6.3|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||6.3|-17.3|
72392210|NCT05425745|144291912|SUPERIORITY||Least Squares (LS) Means|-24.32|STANDARD_ERROR_OF_MEAN|2.583|<|0.0001|TWO_SIDED|95.0|-29.38|-19.25||The hierarchical testing procedure would only be conducted if the previous secondary efficacy endpoint reached a statistically significant treatment effect at p-value\<0.05|ANCOVA|||||-19.25|-29.38|<.0001
72392211|NCT05425745|144291913|SUPERIORITY||Least Squares (LS) Means|-25.77|STANDARD_ERROR_OF_MEAN|3.114|<|0.0001|TWO_SIDED|95.0|-31.88|-19.67||The hierarchical testing procedure would only be conducted if the previous secondary efficacy endpoint reached a statistically significant treatment effect at p-value\<0.05|ANCOVA|||||-19.67|-31.88|<.0001
72370414|NCT01708902|144251480|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.965|STANDARD_ERROR_OF_MEAN|0.916||0.9699|TWO_SIDED|95.0|0.15|6.202|||Regression, Logistic|||"Comparison of 'Main: Linagliptin 2.5mg / Metformin 500mg BID' / 'Main: Metformin 500mg BID'.~The logistic regression includes treatment and continuous baseline HbA1c. The validity of the model is questionable as there is possibly a quasi-complete separation of data points, the results shown are based on the last maximum likelihood iteration."||6.202|0.150|0.9699
72392212|NCT05425745|144291914|SUPERIORITY||Least Squares (LS) Means|-34.45|STANDARD_ERROR_OF_MEAN|2.661|<|0.0001|TWO_SIDED|95.0|-39.67|-29.24||The hierarchical testing procedure would only be conducted if the previous secondary efficacy endpoint reached a statistically significant treatment effect at p-value\<0.05|ANCOVA|||||-29.24|-39.67|<.0001
72392213|NCT05425745|144291915|SUPERIORITY||Least Squares (LS) Means|-33.0|STANDARD_ERROR_OF_MEAN|3.241|<|0.0001|TWO_SIDED|95.0|-39.36|-26.65||The hierarchical testing procedure would only be conducted if the previous secondary efficacy endpoint reached a statistically significant treatment effect at p-value\<0.05|ANCOVA|||||-26.65|-39.36|<.0001
72392214|NCT05425745|144291916|SUPERIORITY||Least Squares (LS) Means|-37.48|STANDARD_ERROR_OF_MEAN|4.535|<|0.0001|TWO_SIDED|95.0|-46.38|-28.58||The hierarchical testing procedure would only be conducted if the previous secondary efficacy endpoint reached a statistically significant treatment effect at p-value \<0.05|ANCOVA|||||-28.58|-46.38|<.0001
72392215|NCT05425745|144291917|SUPERIORITY||Least Squares (LS) Means|138.66|STANDARD_ERROR_OF_MEAN|6.244|<|0.0001|TWO_SIDED|95.0|126.42|150.9||The hierarchical testing procedure would only be conducted if the previous secondary efficacy endpoint reached a statistically significant treatment effect at p-value \<0.05|ANCOVA|||||150.90|126.42|<.0001
72392216|NCT05425745|144291918|SUPERIORITY||Least Squares (LS) Means|131.2|STANDARD_ERROR_OF_MEAN|6.595|<|0.0001|TWO_SIDED|95.0|118.27|144.13||The hierarchical testing procedure would only be conducted if the previous secondary efficacy endpoint reached a statistically significant treatment effect at p-value \<0.05|ANCOVA|||||144.13|118.27|<.0001
72392217|NCT05425745|144291919|SUPERIORITY||Least Squares (LS) Means|121.39|STANDARD_ERROR_OF_MEAN|7.333|<|0.0001|TWO_SIDED|95.0|107.02|135.76||The hierarchical testing procedure would only be conducted if the previous secondary efficacy endpoint reached a statistically significant treatment effect at p-value \<0.05|ANCOVA|||||135.76|107.02|<.0001
72392218|NCT05425745|144291920|SUPERIORITY||Least Squares (LS) Means|-45.94|STANDARD_ERROR_OF_MEAN|10.14|<|0.0001|TWO_SIDED|95.0|-65.88|-26.0||The hierarchical testing procedure would only be conducted if the previous secondary efficacy endpoint reached a statistically significant treatment effect at p-value\<0.05|ANCOVA|||||-26.00|-65.88|<.0001
72392219|NCT05425745|144291921|SUPERIORITY||Least Squares (LS) Means|-54.3|STANDARD_ERROR_OF_MEAN|38.924||0.1648|TWO_SIDED|95.0|-131.13|22.53||The hierarchical testing procedure would only be conducted if the previous secondary efficacy endpoint reached a statistically significant treatment effect at p-value\<0.05; therefore hierarchical testing was stopped for subsequent secondary endpoints|ANCOVA|||||22.53|-131.13|0.1648
72392220|NCT05231954|144291928|SUPERIORITY||Odds Ratio (OR)|1.29||||0.006|TWO_SIDED|95.0|1.08|1.55||P-value is adjusted for multiple comparisons, and a priori threshold for statistical significance is 0.05|Mixed Models Analysis|||||1.55|1.08|0.006
72392221|NCT05231954|144291928|SUPERIORITY||Odds Ratio (OR)|0.82||||0.081|TWO_SIDED|95.0|0.65|1.03||The p-value is adjusted for multiple comparisons, and a priori threshold for statistical significance is 0.05|Mixed Models Analysis|||||1.03|0.65|0.081
72392222|NCT05231954|144291929|SUPERIORITY||Odds Ratio (OR)|1.44||||0.044|TWO_SIDED|95.0|1.01|2.05||The p-value is adjusted for multiple comparisons, and the a priori threshold for statistical significance is 0.05|Mixed Models Analysis|||||2.05|1.01|0.044
72392223|NCT05231954|144291929|SUPERIORITY||Odds Ratio (OR)|1.02||||0.919|TWO_SIDED|95.0|0.69|1.5||The p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance is 0.05|Mixed Models Analysis|||||1.50|0.69|0.919
72500096|NCT02091440|144530387|OTHER|Single group|Change from baseline|19.4|STANDARD_DEVIATION|11.39|||TWO_SIDED|95.0|7.5|31.4|||||Confidence interval based on t-distribution.|||31.4|7.5|
72620673|NCT02037984|144772324|OTHER|PT23F Percentage Point Difference (V114 - Prevnar 13®)|PT23F Percentage Point Difference|0.0|||||TWO_SIDED|95.0|-11.9|9.5|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||9.5|-11.9|
72620674|NCT02037984|144772324|OTHER|non-PT22F Percentage Point Difference (V114 - Prevnar 13®)|non-PT22F Percentage Point Difference|89.2|||||TWO_SIDED|95.0|75.2|95.7|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||95.7|75.2|
72620675|NCT02037984|144772324|OTHER|non-PT33F Percentage Point Difference (V114 - Prevnar 13®)|non-PT33F Percentage Point Difference|93.8|||||TWO_SIDED|95.0|78.5|98.3|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||98.3|78.5|
72622481|NCT00392288|144774960|SUPERIORITY_OR_OTHER|||||||0.9146||95.0||||Due to usage of a-priori ordered hypotheses, adjustment of p-values is not necessary. The pre-specified significance level was 0.05. The tests were carried out two-sided.|ANCOVA|ANCOVA model: Change in FEV1 = baseline FEV1 + age \[yrs\] + treatment + pooled center + previous corticosteroid therapy + holding chamber||This is an analysis of the change from baseline to week 12 or last visit. As statistical test a t-test was used to compare the corresponding least-square means of Ciclesonide 40 versus Placebo.||||0.9146
72562888|NCT00263887|144657499|SUPERIORITY_OR_OTHER|||||||0.049||95.0|||||ANCOVA|||The main effect ANCOVA model includes the change from baseline to endpoint as the dependent variable, treatment and center as fixed factors, change in logarithm of total lung volume and baseline measurement as covariates.||||0.049
72562889|NCT01386125|144657510|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.14||||0.0007|TWO_SIDED|95.0|-0.22|-0.06|||ANCOVA|||||-0.06|-0.22|0.0007
72562890|NCT01386125|144657511|SUPERIORITY_OR_OTHER_LEGACY||Difference is LS Means|-0.3|||<|0.0001|TWO_SIDED|95.0|-0.45|-0.15|||Constrained longitudinal data analysis|||||-0.15|-0.45|<0.0001
72562891|NCT00108550|144657553|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0305|STANDARD_ERROR_OF_MEAN|0.038||0.4237|TWO_SIDED|95.0|-0.044|0.105||There was no need for multiple comparisons adjustment for the primary outcome, since there was only one. However, secondary analyses were adjusted for multiple comparisons.|Mixed Models Analysis|Effect of covariates (age, gender, etc) was evaluated (modeled as fixed effects) in secondary analyses.|The analysis was performed on transformed (rather than raw) Descriptor Differential Score Pain Intensity scores.|The null hypothesis was that Gabapentin is no better than placebo in reducing back pain. A mean-matching variance stabilizing transformation was applied to Descriptor Differential Scale Pain intensity (DDS) scores. Scores were modeled as a function of time (week) and group (gabapentin, placebo) in a mixed effects model. Random (subject-specific)intercept and slopes were fitted to the data. With alpha = .05 and N = 65 per group power is .8 to detect effect size =.4 standard deviations (SD).||0.105|-0.044|0.4237
72562892|NCT00108550|144657554|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5343|STANDARD_ERROR_OF_MEAN|0.7174||0.458|TWO_SIDED|95.0|-1.94|0.872||Primary analyses was multivariable linear regression with fixed and random effects. After the Bonferroni adjustment a p-value would have been considered significant at 0.05 level if \<0.01.|Mixed Models Analysis|||This is a secondary analysis; the null hypothesis is that Gabapentin performs no better than placebo in reducing the Roland and Morris score.||0.872|-1.940|0.458
72562893|NCT00436917|144657587|SUPERIORITY_OR_OTHER_LEGACY|||||||0.01||95.0|||||Kruskal-Wallis|||A sample of 60 participants was estimated to provide percentage statistics accuracy to within 13% with 95% confidence.||||0.01
72622482|NCT02544763|144774963|SUPERIORITY||Percentage reduction|48.6|||||TWO_SIDED|95.0|40.4|55.8||||||||55.8|40.4|
72392224|NCT02891850|144291930|EQUIVALENCE|The hypothesis was that there was no difference in the satisfactory clinical response rates in terms of odds ratio (OR) when treated with riociguat compared with participants who remained on their previous therapy.|Odds Ratio (OR)|2.78||||0.0007|TWO_SIDED|95.0|1.526|5.06|||Mantel Haenszel|Stratified by PAH category at baseline||||5.060|1.526|0.0007
72392225|NCT02891850|144291931|EQUIVALENCE|The hypothesis was that there was no difference in the change of 6MWD in terms of mean difference when treated with riociguat compared with participants who remained on their previous therapy.|Mean Difference (Final Values)|22.56||||0.0542|TWO_SIDED|95.0|5.03|40.1|||t-test, 2 sided|Stratified by PAH category at baseline||||40.10|5.03|0.0542
72392226|NCT02891850|144291932|EQUIVALENCE|The hypothesis was that there was no difference in the change of NT-proBNP in terms of mean difference when treated with riociguat compared with participants who remained on their previous therapy.|Mean Difference (Final Values)|-169.65||||0.1067|TWO_SIDED|95.0|-426.18|86.88|||t-test, 2 sided|Stratified by PAH category at baseline||||86.88|-426.18|0.1067
72392227|NCT02891850|144291933|EQUIVALENCE|The hypothesis was that there was no difference in the change from baseline in WHO FC in terms of mean difference when treated with riociguat compared with participants who remained on their previous therapy.|Mean Difference (Final Values)|-0.26||||0.0007|TWO_SIDED|95.0|-0.42|-0.11|||t-test, 2 sided|Stratified by PAH category at baseline||||-0.11|-0.42|0.0007
72392228|NCT02891850|144291934|EQUIVALENCE|The hypothesis was that there was no difference in the clinical worsening rates in terms of odds ratio (OR) when treated with riociguat compared with participants who remained on their previous therapy.|Odds Ratio (OR)|0.1||||0.0047|TWO_SIDED|95.0|0.013|0.725|||Mantel Haenszel|Stratified by PAH category at baseline||||0.725|0.013|0.0047
72392229|NCT02674529|144291935|OTHER|This was a mechanistic trial and non-inferiority or equivalence analysis were not performed.|regression coefficient|-1.29864|STANDARD_ERROR_OF_MEAN|2.3||0.58|TWO_SIDED|95.0|||||Regression, Linear|Drug (antidepressant vs. placebo) prediction of changes in mood as measured by the MADRS scores.||||||0.58
72392230|NCT02674529|144291935|OTHER||r|0.02||||0.05|TWO_SIDED||||||Correlation|Change in MADRS after 8 weeks correlation with brain responses during the baseline fMRI task.||||||0.05
72392231|NCT02674529|144291936|OTHER|This is a mechanistic trial, we did not perform non-inferiority or equivalence analysis.|regression coefficient|-1.4328918|STANDARD_DEVIATION|1.4||0.8|TWO_SIDED|95.0|||||Regression, Linear|||||||0.8
72455573|NCT02678455|144434181|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|42.0|||||TWO_SIDED|95.0|27.0|58.0||||||Children cohort: percent seropositive to DENV-1 at study day 360 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||58|27|
72562894|NCT02438540|144657599|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|90.0|||||ANOVA|||||||<0.001
72562895|NCT02438540|144657600|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|90.0|||||ANOVA|||||||<0.001
72562896|NCT02438540|144657601|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|90.0|||||ANOVA|||||||<0.001
72562897|NCT02438540|144657602|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|90.0|||||ANOVA|||||||<0.001
72562898|NCT02438540|144657603|SUPERIORITY_OR_OTHER|||||||0.04|TWO_SIDED|90.0|||||ANOVA|||||||0.04
72562899|NCT02438540|144657604|NON_INFERIORITY_OR_EQUIVALENCE|multiple comparatives||||||0.082|TWO_SIDED|90.0||||CRP is known to be an independent parameter|ANOVA|||||||0.082
72562900|NCT02438540|144657604|NON_INFERIORITY_OR_EQUIVALENCE|from 0.60±0.03 mg/dl before treatment to 0.57±0.03 mg/dl after treatment, P=0.082||||||0.082|TWO_SIDED|90.0||||CRP is known to be an independent parameter|ANOVA|||||||0.082
72562901|NCT02438540|144657604|NON_INFERIORITY_OR_EQUIVALENCE|from 0.59±0.03 mg/dl before treatment to 0.57±0.03 mg/dl after treatment, P=0.082||||||0.082|TWO_SIDED|90.0||||CRP is known to be an independent parameter|ANOVA|||||||0.082
72562902|NCT02438540|144657605|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|90.0|||||ANOVA|||||||<0.001
72562903|NCT02438540|144657606|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|90.0|||||ANOVA|||||||<0.001
72622483|NCT02544763|144774963|SUPERIORITY||Percentage reduction|47.5|||||TWO_SIDED|95.0|39.0|54.8||||||||54.8|39.0|
72622484|NCT02544763|144774963|SUPERIORITY||Percentage reduction|26.5|||||TWO_SIDED|95.0|14.9|36.5||||||||36.5|14.9|
72455574|NCT02678455|144434181|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|42.0|||||TWO_SIDED|95.0|27.0|58.0||||||Children cohort: percent seropositive to DENV-1 at study day 720 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||58|27|
72455575|NCT02678455|144434181|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|36.0|||||TWO_SIDED|95.0|22.0|54.0||||||Children cohort: percent seropositive to DENV-1 at study day 1080 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||54|22|
72455576|NCT02678455|144434181|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|33.0|||||TWO_SIDED|95.0|20.0|50.0||||||Children cohort: percent seropositive to DENV-2 at study day 0 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||50|20|
72455577|NCT02678455|144434181|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|92.0|||||TWO_SIDED|95.0|78.0|97.0||||||Children cohort: percent seropositive to DENV-2 at study day 28 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||97|78|
72455578|NCT02678455|144434181|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|89.0|||||TWO_SIDED|95.0|75.0|96.0||||||Children cohort: percent seropositive to DENV-2 at study day 56 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||96|75|
72455579|NCT02678455|144434181|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|92.0|||||TWO_SIDED|95.0|78.0|97.0||||||Children cohort: percent seropositive to DENV-2 at study day 180 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||97|78|
72455580|NCT02678455|144434181|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|78.0|||||TWO_SIDED|95.0|62.0|88.0||||||children cohort: percent seropositive to DENV-2 at study day 360 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||88|62|
72455581|NCT02678455|144434181|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|67.0|||||TWO_SIDED|95.0|50.0|80.0||||||Children cohort: percent seropositive to DENV-2 at study day 720 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||80|50|
72455582|NCT02678455|144434181|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|58.0|||||TWO_SIDED|95.0|42.0|73.0||||||Children cohort: percent seropositive to DENV-2 at study day 1080 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||73|42|
72455583|NCT02678455|144434181|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|36.0|||||TWO_SIDED|95.0|22.0|52.0||||||Children cohort: percent seropositive to DENV-3 at study day 0 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||52|22|
72455584|NCT02678455|144434181|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|92.0|||||TWO_SIDED|95.0|78.0|97.0||||||Children cohort: percent seropositive to DENV-3 at study day 28 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||97|78|
72455585|NCT02678455|144434181|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|92.0|||||TWO_SIDED|95.0|78.0|97.0||||||Children cohort: percent seropositive to DENV-3 at study day 56 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||97|78|
72455586|NCT02678455|144434181|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|97.0|||||TWO_SIDED|95.0|86.0|100.0||||||Children cohort: percent seropositive to DENV-3 at study day 180 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||100|86|
72455587|NCT02678455|144434181|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|72.0|||||TWO_SIDED|95.0|56.0|84.0||||||Children cohort: percent seropositive to DENV-3 at study day 360 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||84|56|
72562904|NCT02438540|144657607|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|90.0|||||ANOVA|||||||<0.001
72455588|NCT02678455|144434181|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|72.0|||||TWO_SIDED|95.0|56.0|84.0||||||Children cohort: percent seropositive to DENV-3 at study day 720 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||84|56|
72455589|NCT02678455|144434181|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|67.0|||||TWO_SIDED|95.0|50.0|80.0||||||Children cohort: percent seropositive to DENV-3 at study day 1080 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||80|50|
72455590|NCT02678455|144434181|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|11.0|||||TWO_SIDED|95.0|4.0|25.0||||||Children cohort: percent seropositive to DENV-4 at study day 0 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||25|4|
72455591|NCT02678455|144434181|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|72.0|||||TWO_SIDED|95.0|56.0|84.0||||||Children cohort: percent seropositive to DENV-4 at study day 28 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||84|56|
72562905|NCT02438540|144657608|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|90.0|||||ANOVA|||||||<0.001
72562906|NCT02438540|144657609|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|90.0|||||ANOVA|||||||<0.001
72562907|NCT02438540|144657610|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|90.0|||||ANOVA|||||||<0.001
72562908|NCT02438540|144657611|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|90.0|||||ANOVA|||||||<0.001
72562909|NCT02438540|144657612|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|90.0|||||ANOVA|||||||<0.001
72562910|NCT02438540|144657613|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|90.0|||||ANOVA|||||||<0.001
72562911|NCT02438540|144657614|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|90.0|||||ANOVA|||||||<0.001
72392232|NCT02674529|144291937|OTHER||||||<|0.05||||||The resulting voxel-wise parametric maps are thresholded with height and extent values generated by Monte Carlo simulations with 3dClustSim to protect against overall type I error at p \< 0.05.|t-test, 2 sided|||At the group-level, a random-effects analysis determines the main effects of the regressors of interest (e.g., high vs. low expectancy) resulting in statistical parametric maps (t or F statistics). To control for potential confounders, sex and depression severity will be entered as covariates in statistical models.||||<0.05
72392233|NCT00004978|144291941|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.94||||0.55|TWO_SIDED|95.0|0.75|1.16||P-value is 2-sided using an alpha of .05.|Regression, Cox|Hazard ratio is from unadjusted proportional hazards regression model.|HR is for rIL-2 vs control.|||1.16|0.75|.55
72392234|NCT00004978|144291942|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.94||||0.62|TWO_SIDED|95.0|0.74|1.2|||Regression, Cox|||||1.20|0.74|.62
72392235|NCT00004978|144291943|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.9||||0.42|TWO_SIDED|95.0|0.69|1.17|||Regression, Cox|||||1.17|0.69|.42
72392236|NCT00004978|144291944|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.91||||0.41|TWO_SIDED|95.0|0.73|1.14|||Regression, Cox|||||1.14|0.73|.41
72392237|NCT00004978|144291945|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|159.0|||||TWO_SIDED|95.0|145.0|174.0|||||treatment difference (rIL2 - no rIL2) estimated from a longitudinal model that considers CD4+ measured at followup visits|||174|145|
72392238|NCT00004978|144291947|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.94||||0.07|TWO_SIDED|95.0|0.88|1.0|||Regression, Cox|Hazard ratio (rIL-2 vs. no rIL-2) for first change in antiretroviral treatment.||||1.00|0.88|.07
72392239|NCT00004978|144291948|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.23||||0.003|TWO_SIDED|95.0|1.07|1.41|||Regression, Cox||HR (IL-2 vs control) for first grade 4 event, ITT analysis.|||1.41|1.07|.003
72392240|NCT00004978|144291949|SUPERIORITY_OR_OTHER_LEGACY|||||||0.97||95.0|||||Chi-squared|||||||.97
72392241|NCT00004978|144291950|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.96||||0.74|TWO_SIDED|95.0|0.76|1.22|||Regression, Cox|||||1.22|0.76|.74
72392242|NCT03761277|144291952|NON_INFERIORITY|This analysis was to demonstrate pain intensity scores (VAS) at the 6-Month Visit is non-inferior to VAS at Baseline, i.e., the change in pain intensity is not greater than 0 by more than 10 points from Baseline to the 6-Month Visit, with change calculated as 6-Month - Baseline.|Mean Difference (Final Values)|-15.0|STANDARD_DEVIATION|25.0|<|0.001|ONE_SIDED|97.5||-7.1|||Wilcoxon Signed Rank test|||This analysis was to demonstrate pain intensity scores (VAS) at the 6-Month Visit is non-inferior to VAS at Baseline, i.e., the change in pain intensity is not greater than 0 by more than 10 points from Baseline to the 6-Month Visit.|Due to non-normality, the non-inferiority test was conducted using a Wilcoxon Signed Rank test, rather than a one-sample t-test. Mean reduction in VAS and the upper 97.5% confidence limit are presented, but the change from baseline was evaluated using non-parametric analysis methods.|-7.1||< 0.001
72392243|NCT03761277|144291952|SUPERIORITY|This analysis was to demonstrate pain intensity scores (VAS) at the 6-Month Visit are less than VAS at Baseline, i.e., the reduction in pain intensity is less than 0 from Baseline to the 6-Month Visit, with change calculated as 6-Month - Baseline.|Mean Difference (Final Values)|-15.0|STANDARD_DEVIATION|25.0|<|0.001|TWO_SIDED|95.0|-22.7|-7.1|||Wilcoxon Signed Rank test|||This analysis was to demonstrate pain intensity scores (VAS) at the 6-Month Visit are less than VAS at Baseline, i.e., the reduction in pain intensity is less than 0 from Baseline to the 6-Month Visit.|Due to non-normality, the superiority test was conducted using a Wilcoxon Signed Rank test, rather than a one-sample t-test. Mean reduction in VAS and 95% confidence interval are presented, but the change from baseline was evaluated using non-parametric analysis methods.|-7.1|-22.7|< 0.001
72392244|NCT03808493|144291981|EQUIVALENCE|For log-transformed (natural log) AUClast, the two-sided 90% CI of the difference in the least square means (LS-Means) between the formulations (TAK-438 OD tablet-TAK-438 tablet) was provided using the ANOVA model.|LS-Means Difference|-0.0211|||||TWO_SIDED|90.0|-0.0752|0.0329||||||||0.0329|-0.0752|
72392245|NCT03808493|144291981|EQUIVALENCE|For log-transformed (natural log) AUClast, the two-sided 90% CI of the difference in the LS-Means between the formulations (TAK-438 OD tablet-TAK-438 tablet) was provided using the ANOVA model.|LS-Means Difference|0.0019|||||TWO_SIDED|90.0|-0.0778|0.0815||||||||0.0815|-0.0778|
72392246|NCT03808493|144291982|EQUIVALENCE|For log-transformed (natural log) Cmax, the two-sided 90% CI of the difference in the LS-Means between the formulations (TAK-438 OD tablet-TAK-438 tablet) was provided using the ANOVA model.|LS-Means Difference|-0.0698|||||TWO_SIDED|90.0|-0.1404|0.0008||||||||0.0008|-0.1404|
72392247|NCT03808493|144291982|EQUIVALENCE|For log-transformed (natural log) Cmax, the two-sided 90% CI of the difference in the LS-Means between the formulations (TAK-438 OD tablet-TAK-438 tablet) was provided using the ANOVA model.|LS-Means Difference|-0.0811|||||TWO_SIDED|90.0|-0.1658|0.0036||||||||0.0036|-0.1658|
72392248|NCT03808493|144291983|EQUIVALENCE|For log-transformed (natural log) AUC∞, the two-sided 90% CI of the difference in the LS-Means between the formulations (TAK-438 OD tablet-TAK-438 tablet) was provided using the ANOVA model.|LS-Means Difference|-0.0199|||||TWO_SIDED|90.0|-0.0731|0.0333||||||||0.0333|-0.0731|
72392249|NCT03808493|144291983|EQUIVALENCE|For log-transformed (natural log) AUC∞, the two-sided 90% CI of the difference in the LS-Means between the formulations (TAK-438 OD tablet-TAK-438 tablet) was provided using the ANOVA model.|LS-Means Difference|0.0035|||||TWO_SIDED|90.0|-0.076|0.083||||||||0.0830|-0.0760|
72562912|NCT02438540|144657615|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|90.0|||||ANOVA|||||||<0.001
72392250|NCT03808493|144291984|EQUIVALENCE|For log-transformed (natural log) Tmax, the two-sided 90% CI of the difference in the LS-Means between the formulations (TAK-438 OD tablet-TAK-438 tablet) was provided using the ANOVA model.|LS-Means Difference|0.1902|||||TWO_SIDED|90.0|0.0199|0.3605||||||||0.3605|0.0199|
72562913|NCT02438540|144657616|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|90.0|||||ANOVA|||||||<0.001
72562914|NCT00476593|144657627|SUPERIORITY_OR_OTHER|||||||0.018|TWO_SIDED|95.0||||Hypothesis: the use of diclofenac/dexamethasone does not influence macular thickness in treated eyes compared with untreated eyes of same subject.|t-test, 2 sided|The possible effect of both anti-inflammatory medications was tested in relation to participants' age and gender||Subjects who received diclofenac or dexamethasone eye drops in one eye. Macular thickness in both were compared between same subjects' eyes after 3 day's treatment. Diclofenac and dexamethasone treated eyes were not compared with each other, but with the contralateral eye of same subject by a paired Student's t-test in each medication group||||0.018
72455592|NCT02678455|144434181|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|56.0|||||TWO_SIDED|95.0|40.0|70.0||||||Children cohort: percent seropositive to DENV-4 at study day 56 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||70|40|
72455593|NCT02678455|144434181|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|44.0|||||TWO_SIDED|95.0|30.0|60.0||||||children cohort: percent seropositive to DENV-4 at study day 180 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||60|30|
72455594|NCT02678455|144434181|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|28.0|||||TWO_SIDED|95.0|16.0|44.0||||||Children cohort: percent seropositive to DENV-4 at study day 360 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||44|16|
72455595|NCT02678455|144434181|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|25.0|||||TWO_SIDED|95.0|14.0|41.0||||||Children cohort: percent seropositive to DENV-4 at study day 720 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||41|14|
72455596|NCT02678455|144434181|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|19.0|||||TWO_SIDED|95.0|10.0|35.0||||||children cohort: percent seropositive to DENV-4 at study day 1080 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||35|10|
72455597|NCT02678455|144434181|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|11.0|||||TWO_SIDED|95.0|4.0|25.0||||||Young children cohort: percent seropositive to DENV-1 at study day 0 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||25|4|
72455598|NCT02678455|144434181|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|78.0|||||TWO_SIDED|95.0|62.0|88.0||||||Young children cohort: percent seropositive to DENV-1 at study day 28 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||88|62|
72455599|NCT02678455|144434181|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|42.0|||||TWO_SIDED|95.0|27.0|58.0||||||young children cohort: percent seropositive to DENV-1 at study day 56 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||58|27|
72455600|NCT02678455|144434181|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|53.0|||||TWO_SIDED|95.0|37.0|68.0||||||young children cohort: percent seropositive to DENV-1 at study day 180 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||68|37|
72455601|NCT02678455|144434181|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|28.0|||||TWO_SIDED|95.0|16.0|44.0||||||Young children cohort: percent seropositive to DENV-1 at study day 360 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||44|16|
72455602|NCT02678455|144434181|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|28.0|||||TWO_SIDED|95.0|16.0|44.0||||||young children cohort: percent seropositive to DENV-1 at study day 720 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||44|16|
72370415|NCT01708902|144251480|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.183|STANDARD_ERROR_OF_MEAN|0.147||0.0343|TWO_SIDED|95.0|0.038|0.882|||Regression, Logistic|||"Comparison of 'Main: Linagliptin 2.5mg / Metformin 500mg BID' / 'Main: Linagliptin 5mg QD'.~The logistic regression includes treatment and continuous baseline HbA1c. The validity of the model is questionable as there is possibly a quasi-complete separation of data points, the results shown are based on the last maximum likelihood iteration."||0.882|0.038|0.0343
72455603|NCT02678455|144434181|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|28.0|||||TWO_SIDED|95.0|16.0|44.0||||||Young children cohort: percent seropositive to DENV-1 at study day 1080 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||44|16|
72455604|NCT02678455|144434181|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|11.0|||||TWO_SIDED|95.0|4.0|25.0||||||Young children cohort: percent seropositive to DENV-2 at study day 0 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||25|4|
72455605|NCT02678455|144434181|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|97.0|||||TWO_SIDED|95.0|86.0|100.0||||||Young children cohort: percent seropositive to DENV-2 at study day 28 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||100|86|
72455606|NCT02678455|144434181|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|86.0|||||TWO_SIDED|95.0|71.0|94.0||||||young children cohort: percent seropositive to DENV-2 at study day 56 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||94|71|
72455607|NCT02678455|144434181|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|81.0|||||TWO_SIDED|95.0|65.0|90.0||||||Young children cohort: percent seropositive to DENV-2 at study day 180 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||90|65|
72455608|NCT02678455|144434181|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|83.0|||||TWO_SIDED|95.0|68.0|92.0||||||young children cohort: percent seropositive to DENV-2 at study day 360 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||92|68|
72455609|NCT02678455|144434181|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|Slope|72.0|||||TWO_SIDED|95.0|56.0|84.0||||||young children cohort: percent seropositive to DENV-2 at study day 720 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||84|56|
72622485|NCT02544763|144774963|SUPERIORITY||Treatment ratio|0.699|||=|0.0009|TWO_SIDED|95.0|0.567|0.861|||Mixed Models Analysis|||||0.861|0.567|=0.0009
72455610|NCT02678455|144434181|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|69.0|||||TWO_SIDED|95.0|53.0|82.0||||||Young children cohort: percent seropositive to DENV-2 at study day 1080 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||82|53|
72455611|NCT02678455|144434181|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|8.0|||||TWO_SIDED|95.0|3.0|22.0||||||Young children cohort: percent seropositive to DENV-3 at study day 0 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||22|3|
72370416|NCT01708902|144251481|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.114|STANDARD_ERROR_OF_MEAN|0.125||0.0474|TWO_SIDED|95.0|0.013|0.976|||Regression, Logistic|||"Comparison of 'APG: Linagliptin 2.5mg / Metformin 1000mg BID' / 'APG: Linagliptin 5mg QD'.~The logistic regression includes treatment and continuous baseline HbA1c."||0.976|0.013|0.0474
72455612|NCT02678455|144434181|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|86.0|||||TWO_SIDED|95.0|71.0|94.0||||||Young children cohort: percent seropositive to DENV-3 at study day 28 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||94|71|
72455613|NCT02678455|144434181|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|67.0|||||TWO_SIDED|95.0|50.0|80.0||||||young children cohort: percent seropositive to DENV-3 at study day 56 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||80|50|
72392251|NCT03808493|144291984|EQUIVALENCE|For log-transformed (natural log) Tmax, the two-sided 90% CI of the difference in the LS-Means between the formulations (TAK-438 OD tablet-TAK-438 tablet) was provided using the ANOVA model.|LS-Means Difference|0.2142|||||TWO_SIDED|90.0|0.0558|0.3725||||||||0.3725|0.0558|
72392252|NCT03808493|144291985|EQUIVALENCE|For log-transformed (natural log) MRT∞,ev, the two-sided 90% CI of the difference in the LS-Means between the formulations (TAK-438 OD tablet-TAK-438 tablet) was provided using the ANOVA model.|LS-Means Difference|0.0311|||||TWO_SIDED|90.0|0.0022|0.0599||||||||0.0599|0.0022|
72455614|NCT02678455|144434181|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|50.0|||||TWO_SIDED|95.0|34.0|66.0||||||young children cohort: percent seropositive to DENV-3 at study day 180 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||66|34|
72562915|NCT00476593|144657627|SUPERIORITY_OR_OTHER|||||||0.024|TWO_SIDED|95.0|||||t-test, 2 sided|||Patient's healthy eyes were compared with sex and age matched healthy controls with Two Sample Student't t-test. Null hypothesis was that quiet, currently unaffected eyes of patients had same macular thickness as age and sex matched controls.||||0.024
72562916|NCT01235442|144657654|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.05|||<|0.001|TWO_SIDED|95.0|1.46|2.87||Overall significance level for primary and secondary endpoints controlled based on a combination of sequential testing and Hommel procedures.|Cochran-Mantel-Haenszel|The test is stratified by baseline BMI(=\<35 or \>35) and prior anti-TNF exposure(Yes or no).||||2.87|1.46|<0.001
72562917|NCT01235442|144657655|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.96|||<|0.001|TWO_SIDED|95.0|1.4|2.75||Overall significance level for primary and secondary endpoints controlled based on a combination of sequential testing and Hommel procedures.|Cochran-Mantel-Haenszel|The test is stratified by baseline BMI (=\<35 or \>35) and prior anti-TNF exposure (Yes or No).||||2.75|1.40|<0.001
72562918|NCT01235442|144657656|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.78||||0.009|TWO_SIDED|95.0|1.21|2.64||Overall significance level for primary and secondary endpoints controlled based on a combination of sequential testing and Hommel procedures.|Cochran-Mantel-Haenszel|The test is stratified by baseline BMI (=\<35 or \>35) and prior anti-TNF exposure (Yes or No).||||2.64|1.21|0.009
72562919|NCT01235442|144657657|SUPERIORITY_OR_OTHER|||||||0.006||||||Overall significance level for primary and secondary endpoints controlled based on a combination of sequential testing and Hommel procedures.|Cochran-Mantel-Haenszel|The test is stratified by baseline BMI (=\<35 or \>35) and prior anti-TNF exposure (Yes or No) with with modified ridit scores.||||||0.006
72562920|NCT01235442|144657658|SUPERIORITY_OR_OTHER||||||<|0.001||||||Overall significance level for primary and secondary endpoints controlled based on a combination of sequential testing and Hommel procedures.|van Elteren test|The test is stratified by baseline BMI (=\<35 or \>35) and prior anti-TNF exposure (Yes or No).||||||<0.001
72562921|NCT01235442|144657659|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.3||||0.135|TWO_SIDED|95.0|0.92|1.85||Overall significance level for primary and secondary endpoints controlled based on a combination of sequential testing and Hommel procedures.|Cochran-Mantel-Haenszel|The test is adjusted for baseline BMI (=\<35 or \>35) and prior anti-TNF (Yes or No).||||1.85|0.92|0.135
72562922|NCT01235442|144657660|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.34||||0.135|TWO_SIDED|95.0|0.96|1.87||Overall significance level for primary and secondary endpoints controlled based on a combination of sequential testing and Hommel procedures.|Cochran-Mantel-Haenszel|The test is stratified by baseline BMI (=\<35 or \>35) and prior anti-TNF exposure (Yes or No).||||1.87|0.96|0.135
72370417|NCT02445794|144251513|SUPERIORITY|||||||0.008|||||||Wilcoxon (Mann-Whitney)|||||||.008
72392253|NCT03808493|144291985|EQUIVALENCE|For log-transformed (natural log) MRT∞,ev, the two-sided 90% CI of the difference in the LS-Means between the formulations (TAK-438 OD tablet-TAK-438 tablet) was provided using the ANOVA model.|LS-Means Difference|0.0306|||||TWO_SIDED|90.0|-0.0003|0.0616||||||||0.0616|-0.0003|
72455615|NCT02678455|144434181|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|25.0|||||TWO_SIDED|95.0|14.0|41.0||||||young children cohort: percent seropositive to DENV-3 at study day 360 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||41|14|
72562923|NCT01118026|144657708|SUPERIORITY|||||||0.9669|||||||Log Rank|||||||0.9669
72622486|NCT02544763|144774963|SUPERIORITY||Treatment ratio|0.715|||=|0.0018|TWO_SIDED|95.0|0.58|0.881|||Mixed Models Analysis|||||0.881|0.580|=0.0018
72622487|NCT02544763|144774964|SUPERIORITY||Odds Ratio (OR)|1.95|||=|0.0692|TWO_SIDED|95.0|0.95|4.0|||Cochran-Mantel-Haenszel|The p-value was calculated from a Cochran-Mantel-Haenszel test stratified by age group (1-6, 7-11, 12-17 and 18-65 years).||||4.00|0.95|=0.0692
72622488|NCT02544763|144774964|SUPERIORITY||Odds Ratio (OR)|2.29|||=|0.0245|TWO_SIDED|95.0|1.12|4.67|||Cochran-Mantel-Haenszel|The p-value was calculated from a Cochran-Mantel-Haenszel test stratified by age group (1-6, 7-11, 12-17 and 18-65 years).||||4.67|1.12|=0.0245
72455616|NCT02678455|144434181|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|31.0|||||TWO_SIDED|95.0|18.0|47.0||||||young children cohort: percent seropositive to DENV-3 at study day 720 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||47|18|
72500097|NCT02091440|144530388|OTHER|Single group|Percentage change|-83.33|||||TWO_SIDED||||||||Percentage change from 24 months to screening in NYHA classes III and IV. Percentage change is 16.67% - 100% = -83.33%|||||
72500098|NCT02091440|144530389|OTHER|Single group|Change from baseline|130.0|STANDARD_DEVIATION|275.32|||TWO_SIDED|95.0|-158.9|418.9|||||Confidence interval based on t-distribution.|||418.9|-158.9|
72562924|NCT05966090|144657727|NON_INFERIORITY|Non - Inferiority (NI) was to be demonstrated if the upper limit of the 2 sided 95% confidence interval (CI) of the GMC ratio between the Control group (at Day 91) versus Co-administration group (at Day 91) for anti-gE Ab 1-month after the second HZ/su vaccine dose was \<=1.5.|Ratio|1.24|||||TWO_SIDED|95.0|1.08|1.42|||||The analysis of covariance (ANCOVA) model, for logarithm-transformed concentration, included the treatment group and age category at vaccination as fixed effects and the pre-dose log-10 titer as a covariate.|To demonstrate non-inferiority of the humoral immune response to 2 doses of HZ/su vaccine when the first dose of HZ/su vaccine was co-administered with RSVPreF3 OA investigational vaccine, compared to 2 doses of HZ/su vaccine administered alone.||1.42|1.08|
72562925|NCT05966090|144657728|NON_INFERIORITY|NI was to be demonstrated if upper limit of the 2 sided 95% CI of the GMT ratio between the Control group (at Day 61) versus Co-administration group (at Day 31) for RSV-A neutralizing titer 1-month after the RSVPreF3 OA investigational vaccine dose was \<=1.5|ratio|1.14|||||TWO_SIDED|95.0|0.97|1.35|||||The ANCOVA model, for logarithm-transformed titers, included the treatment group and age category at vaccination as fixed effects and the pre-dose log-10 titer as a covariate.|To demonstrate the non-inferiority of RSVPreF3 OA investigational vaccine when co-administered with the first dose of HZ/su vaccine, compared to RSVPreF3 OA investigational vaccine administered alone.||1.35|0.97|
72562926|NCT05966090|144657729|NON_INFERIORITY|NI was to be demonstrated if the upper limit of the 2 sided 95% CI of the GMT ratio between the Control group (at Day 61) versus Co-administration group (at Day 31) for RSV-B neutralizing titer 1-month after the RSVPreF3 OA investigational vaccine dose was \<=1.5.|ratio|0.98|||||TWO_SIDED|95.0|0.84|1.15|||||The ANCOVA model, for logarithm-transformed titers, included the treatment group and age category at vaccination as fixed effects and the pre-dose log-10 titer as a covariate.|To demonstrate the non-inferiority of RSVPreF3 OA investigational vaccine when co-administered with the first dose of HZ/su vaccine, compared to RSVPreF3 OA investigational vaccine administered alone.||1.15|0.84|
72562927|NCT00337428|144657743|NON_INFERIORITY_OR_EQUIVALENCE|The ratio of GMTs (concomitant group / nonconcomitant group) must be greater than 0.5.|||||<|0.001||95.0|||||ANOVA|ANOVA on natural log titer with fixed effects for region, vaccination group and their interaction.||||||<0.001
72562928|NCT00337428|144657744|NON_INFERIORITY_OR_EQUIVALENCE|The ratio of GMTs (concomitant group / nonconcomitant group) must be greater than 0.5.|||||<|0.001||95.0|||||ANOVA|ANOVA on natural log titer with fixed effects for region, vaccination group and their interaction.||||||<0.001
72562929|NCT00337428|144657745|NON_INFERIORITY_OR_EQUIVALENCE|The ratio of GMTs (concomitant group / nonconcomitant group) must be greater than 0.5.|||||<|0.001||95.0|||||ANOVA|ANOVA on natural log titer with fixed effects for region, vaccination group and their interaction.||||||<0.001
72562930|NCT00337428|144657746|NON_INFERIORITY_OR_EQUIVALENCE|The ratio of GMTs (concomitant group / nonconcomitant group) must be greater than 0.5.|||||<|0.001||95.0|||||ANOVA|ANOVA on natural log titer with fixed effects for region, vaccination group and their interaction.||||||<0.001
72562931|NCT00337428|144657747|NON_INFERIORITY_OR_EQUIVALENCE|The difference in seroconversion rates (concomitant group - nonconcomitant group) must be greater than -5%|||||<|0.001|||||||Miettinen and Nurminen|Miettinen and Nurminen method for difference in proportions; Stat Med 1985;4:213-26||||||<0.001
72562932|NCT00337428|144657748|NON_INFERIORITY_OR_EQUIVALENCE|The difference in seroconversion rates (concomitant group - nonconcomitant group) must be greater than -5%|||||<|0.001|||||||Miettinen and Nurminen|Miettinen and Nurminen method for difference in proportions; Stat Med 1985;4:213-26||||||<0.001
72622489|NCT02544763|144774965|SUPERIORITY||Odds Ratio (OR)|2.25|||=|0.0074|TWO_SIDED|95.0|1.24|4.07|||nominal|The global impression of change was analyzed using an ordinal logistic regression model with treatment group as a fixed factor.||||4.07|1.24|=0.0074
72455617|NCT02678455|144434181|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|25.0|||||TWO_SIDED|95.0|14.0|41.0||||||young children cohort: percent seropositive to DENV-3 at study day 1080 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||41|14|
72562933|NCT00337428|144657749|NON_INFERIORITY_OR_EQUIVALENCE|The difference in seroconversion rates (concomitant group - nonconcomitant group) must be greater than -5%|||||<|0.001|||||||Miettinen and Nurminen|Miettinen and Nurminen method for difference in proportions; Stat Med 1985;4:213-26||||||<0.001
72622490|NCT02544763|144774965|SUPERIORITY||Odds Ratio (OR)|1.77|||=|0.058|TWO_SIDED|95.0|0.98|3.2|||nominal|The global impression of change is analyzed using an ordinal logistic regression model with treatment group as a fixed factor.||||3.20|0.98|=0.0580
72500099|NCT03576144|144530400|OTHER||Slope|1.0474|STANDARD_ERROR_OF_MEAN|0.0283|||TWO_SIDED|90.0|0.9997|1.0951|||ANCOVA||Standard Error of the mean is actually standard error of slope.Based on the estimate for the slope parameter (β), a 2-sided 90% CI for the slope was computed. Perfect dose proportionality would correspond to a slope of 1.|Dose proportionality for AUC0-12 of BI 1265162 in plasma was assessed using a power model (regression model applied to log-transformed data). The corresponding ANCOVA model included the logarithm of the dose as a covariate. No statistical hypotheses were tested in a confirmatory sense.||1.0951|0.9997|
72562934|NCT00337428|144657750|NON_INFERIORITY_OR_EQUIVALENCE|The difference in seroconversion rates (concomitant group - nonconcomitant group) must be greater than -5%|||||<|0.001|||||||Miettinen and Nurminen|Miettinen and Nurminen method for difference in proportions; Stat Med 1985;4:213-26||||||<0.001
72562935|NCT00337428|144657751|NON_INFERIORITY_OR_EQUIVALENCE|The difference in seroconversion rates (concomitant group - nonconcomitant group) must be greater than -10%|||||<|0.001||95.0|||||Miettinen and Nurminen|Miettinen and Nurminen method for difference in proportions; Stat Med 1985;4:213-26||||||<0.001
72620676|NCT03211858|144772354|NON_INFERIORITY|Non-inferiority of SAR341402 over NovoLog/NovoRapid was demonstrated if upper bound of the 2-sided 95% confidence interval (CI) of the difference between SAR341402 and NovoLog/NovoRapid was \<0.3%. If non-inferiority was demonstrated, using a hierarchical step down testing procedure, the inverse non-inferiority of NovoLog/NovoRapid over SAR341402 was tested and was demonstrated if lower bound of the 2-sided 95% CI of the difference between SAR341402 and NovoLog/NovoRapid was \> -0.3%.|LS Mean difference|-0.08|STANDARD_ERROR_OF_MEAN|0.059|||TWO_SIDED|95.0|-0.192|0.039|||||SAR341402 vs NovoLog/NovoRapid|Analysis was performed using ANCOVA with treatment group (SAR341402, NovoLog/NovoRapid), the randomization strata of geographical region, type of diabetes and prior use of NovoLog/NovoRapid as fixed categorical effects, as well as the continuous fixed covariate of baseline HbA1c value.||0.039|-0.192|
72392254|NCT03808493|144291986|EQUIVALENCE|For log-transformed (natural log) λz, the two-sided 90% CI of the difference in the LS-Means between the formulations (TAK-438 OD tablet-TAK-438 tablet) was provided using the ANOVA model.|LS-Means Difference|0.0209|||||TWO_SIDED|90.0|-0.0112|0.053||||||||0.0530|-0.0112|
72392255|NCT03808493|144291986|EQUIVALENCE|For log-transformed (natural log) λz, the two-sided 90% CI of the difference in the LS-Means between the formulations (TAK-438 OD tablet-TAK-438 tablet) was provided using the ANOVA model.|LS-Means Difference|-0.0135|||||TWO_SIDED|90.0|-0.0508|0.0238||||||||0.0238|-0.0508|
72392256|NCT00429273|144292033|OTHER|Test for differences in treatment outcomes between three different tx|F-Value for variance component|18.9|||<|0.01|TWO_SIDED||||||Mixed Models Analysis|||Analyses are based on a generalized linear mixed model (GLMM) modelling the effects of the medication when calibrated to optimal dosage and controlling for time effects and within-subject effects. The design is a combined within-between subject design, where each participant is exposed to, and provides information about multiple tx modalities.||||<.01
72455618|NCT02678455|144434181|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|3.0|||||TWO_SIDED|95.0|0.0|14.0||||||young children cohort: percent seropositive to DENV-4 at study day 0 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||14|0|
72455619|NCT02678455|144434181|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|89.0|||||TWO_SIDED|95.0|75.0|96.0||||||young children cohort: percent seropositive to DENV-4 at study day 28 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||96|75|
72455620|NCT02678455|144434181|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|72.0|||||TWO_SIDED|95.0|56.0|96.0||||||young children cohort: percent seropositive to DENV-4 at study day 56 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||96|56|
72500100|NCT03576144|144530401|OTHER||Slope|1.0091|STANDARD_ERROR_OF_MEAN|0.038|||TWO_SIDED|90.0|0.9451|1.0732|||ANCOVA||Standard Error of the is actually standard error of slope. Based on the estimate for the slope parameter (β), a 2-sided 90% CI for the slope was computed. Perfect dose proportionality would correspond to a slope of 1.|Dose proportionality for Cmax of BI 1265162 in plasma was assessed using a power model (regression model applied to log-transformed data). The corresponding ANCOVA model included the logarithm of the dose as a covariate. No statistical hypotheses were tested in a confirmatory sense.||1.0732|0.9451|
72392257|NCT01438957|144292034|SUPERIORITY||||||<|0.001|TWO_SIDED|5.0|||||Mantel Haenszel|Stratified by the anesthesia type||The closed testing procedure is used taking multiplicity into consideration, in which Dexmedetomidine 1.0 mcg/kg group, 0.5 mcg/kg group, 0.25 mcg/kg group, 0.067 mcg/kg group and the placebo group are tested in this order||||<0.001
72500101|NCT03576144|144530402|OTHER||Slope|1.052|STANDARD_ERROR_OF_MEAN|0.0325|||TWO_SIDED|90.0|0.9972|1.1069|||ANCOVA||Standard Error of the mean is actually standard error of slope. Based on the estimate for the slope parameter (β), a 2-sided 90% CI for the slope was computed. Perfect dose proportionality would correspond to a slope of 1.|Dose proportionality for AUCτ,ss of BI 1265162 in plasma was assessed using a power model (regression model applied to log-transformed data). The corresponding ANCOVA model included the logarithm of the dose as a covariate. No statistical hypotheses were tested in a confirmatory sense.||1.1069|0.9972|
72500102|NCT03576144|144530403|OTHER||Slope|1.0361|STANDARD_ERROR_OF_MEAN|0.0379|||TWO_SIDED|90.0|0.9722|1.1001|||ANCOVA||Standard Error of the mean is actually standard error of slope. Based on the estimate for the slope parameter (β), a 2-sided 90% CI for the slope was computed. Perfect dose proportionality would correspond to a slope of 1.|Dose proportionality for Cmax,ss of BI 1265162 in plasma was assessed using a power model (regression model applied to log-transformed data). The corresponding ANCOVA model included the logarithm of the dose as a covariate. No statistical hypotheses were tested in a confirmatory sense.||1.1001|0.9722|
72500103|NCT02354833|144530419|SUPERIORITY_OR_OTHER|||||||0.12|||||||t-test, 2 sided|||||||0.12
72392258|NCT01438957|144292034|SUPERIORITY|||||||0.003|TWO_SIDED|5.0|||||Mantel Haenszel|Stratified by the anesthesia type||||||0.003
72392259|NCT01438957|144292034|SUPERIORITY|||||||0.086|||||||Mantel Haenszel|Stratified by the anesthesia type||||||0.086
72455621|NCT02678455|144434181|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|47.0|||||TWO_SIDED|95.0|32.0|63.0||||||young children cohort: percent seropositive to DENV-4 at study day 180 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||63|32|
72455622|NCT02678455|144434181|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|28.0|||||TWO_SIDED|95.0|16.0|44.0||||||young children cohort: percent seropositive to DENV-4 at study day 360 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||44|16|
72455623|NCT02678455|144434181|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|28.0|||||TWO_SIDED|95.0|16.0|44.0||||||young children cohort: percent seropositive to DENV-4 at study day 720 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||44|16|
72392260|NCT01438957|144292034|SUPERIORITY||||||<|0.001|||||||Mantel-extension test|Stratified by the anesthesia type||Dose-response relationship is assessed using Mantel-extension test. In this analysis, dose of placebo group is hypothesized as 0 microg/kg. Dose-response relationship among Dexmedetomidine 4 dose groups excluding placebo group is also assessed using Mantel-extension test.||||<0.001
72500104|NCT02354833|144530420|SUPERIORITY_OR_OTHER|||||||0.28|||||||Chi-squared|||This analysis is comparing the percentage of participants with Nausea||||0.28
72392261|NCT01438957|144292035|SUPERIORITY||||||<|0.001|TWO_SIDED|5.0|||||Mantel Haenszel|Stratified by the anesthesia type||The closed testing procedure is used taking multiplicity into consideration, in which Dexmedetomidine 1.0 mcg/kg group, 0.5 mcg/kg group, 0.25 mcg/kg group, 0.067 mcg/kg group and the placebo group are tested in this order||||<0.001
72392262|NCT01438957|144292035|SUPERIORITY||||||<|0.001|TWO_SIDED|5.0|||||Mantel Haenszel|Stratified by the anesthesia type||||||<0.001
72392263|NCT01438957|144292035|SUPERIORITY|||||||0.006|TWO_SIDED|5.0|||||Mantel Haenszel|Stratified by the anesthesia type||||||0.006
72392264|NCT01438957|144292035|SUPERIORITY|||||||0.329|TWO_SIDED|5.0|||||Mantel Haenszel|Stratified by the anesthesia type||||||0.329
72392265|NCT01438957|144292036|SUPERIORITY||||||<|0.001|TWO_SIDED|5.0|||||Mantel Haenszel|Stratified by the anesthesia type||The closed testing procedure is used taking multiplicity into consideration, in which Dexmedetomidine 1.0 mcg/kg group, 0.5 mcg/kg group, 0.25 mcg/kg group, 0.067 mcg/kg group and the placebo group are tested in this order||||<0.001
72392266|NCT01438957|144292036|SUPERIORITY||||||<|0.001|TWO_SIDED|5.0|||||Mantel Haenszel|Stratified by the anesthesia type||||||<0.001
72392267|NCT01438957|144292036|SUPERIORITY|||||||0.006|TWO_SIDED|5.0|||||Mantel Haenszel|Stratified by the anesthesia type||||||0.006
72392268|NCT01438957|144292036|SUPERIORITY|||||||0.371|TWO_SIDED|5.0|||||Mantel Haenszel|Stratified by the anesthesia type||||||0.371
72392269|NCT01438957|144292037|SUPERIORITY||||||<|0.001|||||||Log Rank|Stratified by the anesthesia type||The closed testing procedure is used taking multiplicity into consideration, in which Dexmedetomidine 1.0 mcg/kg group, 0.5 mcg/kg group, 0.25 mcg/kg group, 0.067 mcg/kg group and the placebo group are tested in this order||||<0.001
72392270|NCT01438957|144292037|SUPERIORITY|||||||0.001|||||||Log Rank|Stratified by the anesthesia type||||||0.001
72392271|NCT01438957|144292037|SUPERIORITY|||||||0.212|||||||Log Rank|Stratified by the anesthesia type||||||0.212
72562936|NCT00337428|144657752|NON_INFERIORITY_OR_EQUIVALENCE|The difference in seroconversion rates (concomitant group - nonconcomitant group) must be greater than -10%|||||<|0.001||95.0|||||Miettinen and Nurminen|Miettinen and Nurminen method for difference in proportions; Stat Med 1985;4:213-26||||||<0.001
72392272|NCT01438957|144292038|SUPERIORITY|||||||0.869|||||||Mantel Haenszel|Stratified by the anesthesia type||The closed testing procedure is used taking multiplicity into consideration, in which Dexmedetomidine 1.0 mcg/kg group, 0.5 mcg/kg group, 0.25 mcg/kg group, 0.067 mcg/kg group and the placebo group are tested in this order||||0.869
72392273|NCT01438957|144292039|SUPERIORITY|||||||0.897|TWO_SIDED|5.0|||||Mantel Haenszel|Stratified by the anesthesia type||The closed testing procedure is used taking multiplicity into consideration, in which Dexmedetomidine 1.0 mcg/kg group, 0.5 mcg/kg group, 0.25 mcg/kg group, 0.067 mcg/kg group and the placebo group are tested in this order||||0.897
72392274|NCT01438957|144292040|SUPERIORITY|||||||0.897|TWO_SIDED|5.0|||||Mantel Haenszel|Stratified by the anesthesia type||The closed testing procedure is used taking multiplicity into consideration, in which Dexmedetomidine 1.0 mcg/kg group, 0.5 mcg/kg group, 0.25 mcg/kg group, 0.067 mcg/kg group and the placebo group are tested in this order||||0.897
72392275|NCT01438957|144292041|SUPERIORITY||||||<|0.001|||||||Mantel Haenszel|Stratified by the anesthesia type||The closed testing procedure is used taking multiplicity into consideration, in which Dexmedetomidine 1.0 mcg/kg group, 0.5 mcg/kg group, 0.25 mcg/kg group, 0.067 mcg/kg group and the placebo group are tested in this order||||<0.001
72392276|NCT01438957|144292041|SUPERIORITY|||||||0.002|||||||Mantel Haenszel|Stratified by the anesthesia type||||||0.002
72562937|NCT00337428|144657753|NON_INFERIORITY_OR_EQUIVALENCE|The difference in seroconversion rates (concomitant group - nonconcomitant group) must be greater than -10%|||||<|0.001||95.0|||||Miettinen and Nurminen|Miettinen and Nurminen method for difference in proportions; Stat Med 1985;4:213-26||||||<0.001
72392277|NCT01438957|144292041|SUPERIORITY|||||||0.116|||||||Mantel Haenszel|Stratified by the anesthesia type||||||0.116
72392278|NCT01438957|144292042|SUPERIORITY|||||||0.088|||||||Mantel Haenszel|Stratified by the anesthesia type||The closed testing procedure is used taking multiplicity into consideration, in which Dexmedetomidine 1.0 mcg/kg group, 0.5 mcg/kg group, 0.25 mcg/kg group, 0.067 mcg/kg group and the placebo group are tested in this order||||0.088
72392279|NCT01438957|144292043|SUPERIORITY|||||||0.085|||||||Log Rank|Stratified by the anesthesia type||The closed testing procedure is used taking multiplicity into consideration, in which Dexmedetomidine 1.0 mcg/kg group, 0.5 mcg/kg group, 0.25 mcg/kg group, 0.067 mcg/kg group and the placebo group are tested in this order||||0.085
72392280|NCT01438957|144292044|SUPERIORITY|||||||0.005|||||||Mantel Haenszel|Stratified by the anesthesia type||The closed testing procedure is used taking multiplicity into consideration, in which Dexmedetomidine 1.0 mcg/kg group, 0.5 mcg/kg group, 0.25 mcg/kg group, 0.067 mcg/kg group and the placebo group are tested in this order||||0.005
72392281|NCT01438957|144292044|SUPERIORITY|||||||0.014|||||||Mantel Haenszel|Stratified by the anesthesia type||||||0.014
72392282|NCT01438957|144292044|SUPERIORITY|||||||0.055|||||||Mantel Haenszel|Stratified by the anesthesia type||||||0.055
72392283|NCT01438957|144292045|SUPERIORITY|||||||0.737|||||||Mantel Haenszel|Stratified by the anesthesia type||The closed testing procedure is used taking multiplicity into consideration, in which Dexmedetomidine 1.0 mcg/kg group, 0.5 mcg/kg group, 0.25 mcg/kg group, 0.067 mcg/kg group and the placebo group are tested in this order||||0.737
72392284|NCT01438957|144292046|SUPERIORITY|||||||0.11|||||||Mantel Haenszel|Stratified by the anesthesia type||The closed testing procedure is used taking multiplicity into consideration, in which Dexmedetomidine 1.0 mcg/kg group, 0.5 mcg/kg group, 0.25 mcg/kg group, 0.067 mcg/kg group and the placebo group are tested in this order||||0.11
72392285|NCT01438957|144292047|SUPERIORITY|||||||0.567|||||||Mantel Haenszel|Stratified by the anesthesia type||The closed testing procedure is used taking multiplicity into consideration, in which Dexmedetomidine 1.0 mcg/kg group, 0.5 mcg/kg group, 0.25 mcg/kg group, 0.067 mcg/kg group and the placebo group are tested in this order||||0.567
72500105|NCT02354833|144530420|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Chi-squared|||This analysis is comparing the percentage of participants with Emesis||||< 0.001
72562938|NCT00337428|144657754|NON_INFERIORITY_OR_EQUIVALENCE|The difference in seroconversion rates (concomitant group - nonconcomitant group) must be greater than -10%|||||<|0.001||95.0|||||Miettinen and Nurminen|Miettinen and Nurminen method for difference in proportions; Stat Med 1985;4:213-26||||||<0.001
72620677|NCT03160573|144772377|SUPERIORITY||||||<|1e-05|||||||Wilcoxon (Mann-Whitney)|||Test Flavored Rinse, Placebo Flavored Rinse||||<0.00001
72455624|NCT02678455|144434181|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|22.0|||||TWO_SIDED|95.0|12.0|38.0||||||young children cohort: percent seropositive to DENV-4 at study day 1080 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||38|12|
72455625|NCT04323800|144434183|SUPERIORITY||Risk Difference (RD)|0.01||||0.42|ONE_SIDED|95.0||||One-sided p-value|Restricted Mean Survival Test statistic|||||||0.42
72500106|NCT02354833|144530421|SUPERIORITY_OR_OTHER|||||||0.1|||||||Wilcoxon (Mann-Whitney)|||||||0.10
72500107|NCT02354833|144530422|SUPERIORITY_OR_OTHER|||||||0.73|||||||Wilcoxon (Mann-Whitney)|||||||0.73
72370418|NCT00488683|144251630|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|-0.06||||0.69||95.0||||Values from Group 1, 2 and 3 were combined for this analysis.|Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccinations and hSBA titers at 12 months of age for the serogroup A||||0.69
72455626|NCT04323800|144434184|SUPERIORITY||Risk Difference (RD)|-5.0||||0.67|TWO_SIDED|95.0|-31.0|19.0|||Chi-squared|||||19|-31|0.67
72455627|NCT04323800|144434185|SUPERIORITY||Risk Difference (RD)|-47.0||||0.06|TWO_SIDED|95.0|-100.0|2.0|||Chi-squared|||||2|-100|0.06
72455628|NCT01823224|144434271|SUPERIORITY_OR_OTHER|||||||0.875|TWO_SIDED||||||Repeated analysis of variance|||||||0.875
72455629|NCT01823224|144434272|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Manova|||||||> 0.05
72455630|NCT03392194|144434290|OTHER|The purpose of this small pilot randomized control trial (RCT) was to assess feasibility and acceptability of conducting community based sleep hygiene and yoga interventions, to be scaled and tested in a future, larger RCT.|Mean Difference (Net)|-2.02||||0.932|TWO_SIDED|95.0|-46.35|50.39|||t-test, 2 sided|Due to main findings, analysis to explore potential mediators of effect were not pursued, despite original plan to explore explanatory variables.||Null hypothesis: There is no difference in change in sleep duration between the two intervention arms.||50.39|-46.35|0.932
72455631|NCT03068312|144434302|OTHER||Least squares mean difference|-0.66|||||TWO_SIDED|95.0|-1.1|-0.21||||||||-0.21|-1.10|
72455632|NCT02551224|144434303|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.75|||<|0.0001|TWO_SIDED|95.0|0.51|0.99|||Wilcoxon (Mann-Whitney)|||||0.99|0.51|<0.0001
72500108|NCT05817045|144530434|SUPERIORITY|adjusted for the following prognostic baseline covariates: baseline log10 nasopharyngeal viral load, ethnicity, hours since symptom onset, and baseline risk factor score|Hazard Ratio (HR)|1.01||||0.948|TWO_SIDED|95.0|0.777|1.31|||NPANCOVA||For the HR calculation Sham was taken to be the reference group, meaning a HR \> 1 is favorable for RD-X19|NPANCOVA analysis for time to sustained resolution of COVID-19 signs and symptoms without subsequent recurrence or disease progression (until the end of the study) Full Analysis Set (FAS)||1.310|0.777|0.948
72455633|NCT02551224|144434304|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.41|||<|0.0001|TWO_SIDED|95.0|0.21|0.61|||Wilcoxon (Mann-Whitney)|||||0.61|0.21|<0.0001
72455634|NCT00273052|144434305|SUPERIORITY_OR_OTHER||Median Difference (Net)|-8.026||||0.0141||95.0|-15.35|-0.67|||ANCOVA||Median difference = Coreg CR - Toprol XL|||-0.67|-15.35|0.0141
72500109|NCT05817045|144530434|SUPERIORITY|Per-Protocol Population|Hazard Ratio (HR)|1.02||||0.902|TWO_SIDED|95.0|0.774|1.337||adjusted for the following prognostic baseline covariates: baseline log10 nasopharyngeal viral load, ethnicity, hours since symptom onset, and baseline risk factor score.|NPANCOVA||For the HR calculation Sham was taken to be the reference group, meaning a HR \> 1 is favorable for RD-X19|NPANCOVA analysis for time to sustained resolution of COVID-19 signs and symptoms without subsequent symptom recurrence or disease progression (until the end of the study) Per-Protocol Population||1.337|0.774|0.902
72620678|NCT03160573|144772377|SUPERIORITY||||||<|1e-05|||||||Wilcoxon (Mann-Whitney)|||Test Unflavored Rinse, Placebo Unflavored Rinse||||<0.00001
72370419|NCT00488683|144251630|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|0.14||||0.3||95.0||||Values from Group 1, 2 and 3 were combined for this analysis.|Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccinations and hSBA titers at 12 months of age for the serogroup C||||0.30
72370420|NCT00488683|144251630|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|0.81|||<|0.0001||95.0||||Values from Group 1, 2 and 3 were combined for this analysis.|Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccinations and hSBA titers at 12 months of age for the serogroup W-135||||<0.0001
72370421|NCT00488683|144251630|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|0.67||||0.001||95.0||||Values from Groups I, II and III were combined for this analysis.|Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccinations and hSBA titers at 12 months of age for the serogroup Y||||0.001
72370422|NCT00488683|144251630|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|-0.08||||0.61||95.0||||Values from Group 1, 2 and 3 were combined for this analysis.|Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccinations and hSBA titers at 12 months of age for the serogroup A||||0.61
72370423|NCT00488683|144251630|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.31||||0.02||95.0||||Values from Group 1, 2 and 3 were combined for this analysis.|Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccinations and hSBA titers at 12 months of age for the serogroup C||||0.02
72370424|NCT00488683|144251630|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.45||||0.002||95.0||||Values from Group 1, 2 and 3 were combined for this analysis.|Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccinations and hSBA titers at 12 months of age for the serogroup W-135||||0.002
72370425|NCT00488683|144251630|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.4||||0.08||95.0||||Values from Group 1, 2 and 3 were combined for this analysis.|Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccinations and hSBA titers at 12 months of age for the serogroup Y||||0.08
72370426|NCT00488683|144251630|SUPERIORITY_OR_OTHER||R-square|0.004||||||95.0||||Values from Group 1, 2 and 3 were combined for this analysis.|Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccinations and hSBA titers at 12 months of age for the serogroup A||||
72370427|NCT00488683|144251630|SUPERIORITY_OR_OTHER||R-square|0.02||||||95.0||||Values from Group 1, 2 and 3 were combined for this analysis.|Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccinations and hSBA titers at 12 months of age for the serogroup C||||
72370428|NCT00488683|144251630|SUPERIORITY_OR_OTHER||R-square|0.66||||||95.0||||Values from Group 1, 2 and 3 were combined for this analysis.|Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccinations and hSBA titers at 12 months of age for the serogroup W-135||||
72455635|NCT00273052|144434306|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.7||||0.6068||95.0|-2.4|3.9|||ANCOVA||Mean difference = Coreg CR - Toprol XL|||3.9|-2.4|0.6068
72455636|NCT01009645|144434321|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05|ONE_SIDED|95.0||||The a priori threshold for statistical significance was p \<0.0167 as the p-value was adjusted for multiple comparisons (three planned contrasts).|Contrast Analysis|Bonferroni correction used (3 planned contrasts)||Contrast analysis was used to assess difference in vaccination status. The first contrast assessed whether or not the three newly created messages (Fact Only (FO), Fact/Myth (FM), and Fact/Myth/Refutation (FMR)) were as a group significantly different than the control message.||||<0.05
72455637|NCT01009645|144434321|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05|ONE_SIDED|95.0||||The a priori threshold for statistical significance was p \<0.0167 as the p-value was adjusted for multiple comparisons (three planned contrasts).|Contrast Analysis|Bonferroni correction used (3 planned contrasts)||Contrast analysis was used to assess difference in vaccination status. The second contrast assessed whether the FO and FMR conditions were significantly different from the FM message.||||<0.05
72455638|NCT01009645|144434321|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05|ONE_SIDED|95.0||||The a priori threshold for statistical significance was p \<0.0167 as the p-value was adjusted for multiple comparisons (three planned contrasts).|Contrast Analysis|Bonferroni correction used (3 planned contrasts)||Contrast analysis was used to assess difference in vaccination status. The third contrast assessed whether the FO and the FMR message conditions were significantly different.||||<0.05
72455639|NCT01009645|144434322|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05||95.0|||||ANOVA|used Scheffe's post-hoc analysis||||||<0.05
72455640|NCT00768755|144434371|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.831||||0.3037|TWO_SIDED|95.0|0.508|1.36|||Log Rank|One-sided log-rank test at alpha = 0.20 significance level was used.||P-value was calculated using 1-sided log rank test, stratified by Eastern Cooperative Oncology Group (ECOG) performance status (0 or 1) and gender (male or female). Hazard ratio (HR): the stratified Cox model was fitted, using the same stratification variables as above.||1.360|0.508|0.3037
72455641|NCT00768755|144434371|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.947||||0.3565|TWO_SIDED|95.0|0.58|1.546|||Log Rank|One-sided log-rank test at alpha = 0.20 significance level was used.||P-value was calculated using 1-sided log rank test, stratified by ECOG performance status (0 or 1) and gender (male or female). HR: the stratified Cox model was fitted, using the same stratification variables as above.||1.546|0.580|0.3565
72455642|NCT00768755|144434372|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.046||||0.5785|TWO_SIDED|95.0|0.648|1.69|||Log Rank|One-sided log-rank test at alpha = 0.20 significance level was used.||P-value was calculated using 1-sided log rank test, stratified by ECOG performance status (0 or 1) and gender (male or female). HR: the stratified Cox model was fitted, using the same stratification variables as above.||1.690|0.648|0.5785
72455643|NCT00768755|144434372|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.449||||0.9392|TWO_SIDED|95.0|0.919|2.285|||Log Rank|One-sided log-rank test at alpha = 0.20 significance level was used.||P-value was calculated using 1-sided log rank test, stratified by ECOG performance status (0 or 1) and gender (male or female). HR: the stratified Cox model was fitted, using the same stratification variables as above.||2.285|0.919|0.9392
72455644|NCT00768755|144434373|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.753||||0.0143|TWO_SIDED|95.0|1.047|2.935|||Cochran-Mantel-Haenszel|||P-value was calculated using Cochran-Mantel-Haenszel (CMH) test stratified by ECOG performance status (0 or 1) and gender (male or female).||2.935|1.047|0.0143
72455645|NCT00768755|144434373|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.512||||0.0665|TWO_SIDED|95.0|0.87|2.626|||Cochran-Mantel-Haenszel|||P-value was calculated using CMH test stratified by ECOG performance status (0 or 1) and gender (male or female).||2.626|0.870|0.0665
72455646|NCT04660799|144434454|NON_INFERIORITY|The lower limit of the two-sided 90% confidence interval (CI) should be above 0.80 in order to show non-inferiority of Ctrough SC versus Ctrough IV.|Ratio Ctrough SC/Ctrough IV|1.52|||||TWO_SIDED|90.0|1.28|1.79||||||Geometric mean ratio of Ctrough SC/Ctrough IV and 90% confidence interval were estimated based on an ANCOVA model adjusted for tumor load at baseline.||1.79|1.28|
72455647|NCT04660799|144434455|NON_INFERIORITY|The lower limit of the two-sided 90% confidence interval (CI) should be above 0.80 in order to show non-inferiority of AUCsc versus AUCiv.|Geometric mean ratio of AUCsc/AUCiv|1.25|||||TWO_SIDED|90.0|1.1|1.42||||||Geometric mean ratio of AUCsc/AUCiv and 90% confidence interval were estimated based on an ANCOVA model adjusted for tumor load at baseline.||1.42|1.10|
72455648|NCT04660799|144434460|SUPERIORITY||Difference in CRR|18.27|||||TWO_SIDED|95.0|-8.92|45.45||||||Stratified by IPI score: IPI 0-2 = low to low-intermediate risk versus IPI 3-5 = high-intermediate to high risk||45.45|-8.92|
72455649|NCT04660799|144434461|SUPERIORITY||Difference in ORR Investigator|17.63|||||TWO_SIDED|95.0|-6.86|42.11||||||Investigator; Stratified by IPI score: IPI 0-2 = low to low-intermediate risk versus IPI 3-5 = high-intermediate to high risk||42.11|-6.86|
72455650|NCT04660799|144434461|SUPERIORITY||Difference in ORR IRC|14.1|||||TWO_SIDED|95.0|-12.68|40.88||||||IRC; Stratified by IPI score: IPI 0-2 = low to low-intermediate risk versus IPI 3-5 = high-intermediate to high risk||40.88|-12.68|
72455651|NCT04660799|144434462|SUPERIORITY||Difference in CRR|7.05|||||TWO_SIDED|95.0|-22.49|36.59||||||Stratified by IPI score: IPI 0-2 = low to low-intermediate risk versus IPI 3-5 = high-intermediate to high risk||36.59|-22.49|
72455652|NCT04660799|144434463|SUPERIORITY||Difference in CRR|18.59|||||TWO_SIDED|95.0|-9.55|46.73||||||Stratified by IPI score: IPI 0-2 = low to low-intermediate risk versus IPI 3-5 = high-intermediate to high risk||46.73|-9.55|
72455653|NCT01934452|144434468|SUPERIORITY||Hodges Lehmann estimator|2.8|||<|0.001|TWO_SIDED|95.0|2.2|3.8|||Wilcoxon (Mann-Whitney)|||||3.8|2.2|<0.001
72370429|NCT00488683|144251630|SUPERIORITY_OR_OTHER||R-square|0.45||||||95.0||||Values from Group 1, 2 and 3 were combined for this analysis.|Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccinations and hSBA titers at 12 months of age for the serogroup Y||||
72455654|NCT01934452|144434469|SUPERIORITY|||||||0.001|||||||Chi-squared|||||||0.001
72455655|NCT01934452|144434470|SUPERIORITY|||||||1|||||||Fisher Exact|||Extended or partial nephrectomy||||1.000
72455656|NCT01934452|144434470|SUPERIORITY|||||||0.809|||||||Chi-squared|||Nephrectomy with or without adrenalectomy||||0.809
72455657|NCT01934452|144434470|SUPERIORITY|||||||0.019|||||||Chi-squared|||Nephrectomy with or without curettage||||0.019
72455658|NCT01934452|144434470|SUPERIORITY|||||||0.734|||||||Fisher Exact|||Open or laparoscopic nephrectomy||||0.734
72455659|NCT01934452|144434471|SUPERIORITY||Hodges Lehmann estimator|-3.7||||0.23|TWO_SIDED|95.0|-13.2|1.6|||Wilcoxon (Mann-Whitney)|||||1.6|-13.2|0.230
72455660|NCT01934452|144434472|SUPERIORITY|||||||0.695|||||||Fisher Exact|||Sarcomatoid contingent||||0.695
72455661|NCT01934452|144434473|SUPERIORITY|||||||0.316|||||||Chi-squared|||M class||||0.316
72455662|NCT01934452|144434474|SUPERIORITY||Hodges Lehmann estimator|-2.0||||0.778|TWO_SIDED|95.0|-22.0|18.0|||Wilcoxon (Mann-Whitney)|||||18.0|-22.0|0.778
72455663|NCT01934452|144434475|SUPERIORITY|||||||0.812|||||||Fisher Exact|||||||0.812
72455664|NCT01934452|144434476|SUPERIORITY||Odds Ratio (OR)|2.47||||0.077|TWO_SIDED|95.0|0.9|6.77|||Chi-squared|||Presence of necrosis||6.77|0.90|0.077
72455665|NCT01934452|144434476|SUPERIORITY||Odds Ratio (OR)|1.25||||0.673|TWO_SIDED|95.0|0.44|3.52|||Chi-squared|||Vascular embolism||3.52|0.44|0.673
72455666|NCT01934452|144434476|SUPERIORITY||Odds Ratio (OR)|1.04||||1|TWO_SIDED|95.0|0.27|3.97|||Fisher Exact|||Sarcomatoid component||3.97|0.27|1.000
72455667|NCT01934452|144434477|SUPERIORITY||Hodges Lehmann estimator|-0.2||||0.865|TWO_SIDED|95.0|-1.5|1.6|||Wilcoxon (Mann-Whitney)|||||1.6|-1.5|0.865
72455668|NCT01934452|144434478|SUPERIORITY|||||||0.011|||||||Chi-squared|||Lung||||0.011
72455669|NCT01934452|144434478|SUPERIORITY|||||||0.132|||||||Chi-squared|||Bones||||0.132
72455670|NCT01934452|144434478|SUPERIORITY|||||||0.473|||||||Chi-squared|||Liver||||0.473
72455671|NCT01934452|144434478|SUPERIORITY|||||||0.101|||||||Fisher Exact|||Adrenal glands||||0.101
72455672|NCT01934452|144434478|SUPERIORITY|||||||0.445|||||||Fisher Exact|||Pancreas||||0.445
72455673|NCT01934452|144434478|SUPERIORITY|||||||0.04|||||||Chi-squared|||Lymph nodes||||0.040
72455674|NCT01934452|144434479|SUPERIORITY|||||||1|||||||Fisher Exact|||Supradiaphragmatic||||1.000
72455675|NCT01934452|144434479|SUPERIORITY|||||||0.295|||||||Fisher Exact|||Infradiaphragmatic||||0.295
72562939|NCT00337428|144657755|NON_INFERIORITY_OR_EQUIVALENCE|The difference in seroconversion rates (concomitant group - nonconcomitant group) must be greater than -10%|||||<|0.001||95.0|||||Miettinen and Nurminen|Miettinen and Nurminen method for difference in proportions; Stat Med 1985;4:213-26||||||<0.001
72455676|NCT01934452|144434480|SUPERIORITY|||||||0.042|||||||Fisher Exact|||||||0.042
72455677|NCT01934452|144434481|SUPERIORITY|||||||0.027|||||||Chi-squared|||||||0.027
72455678|NCT01934452|144434482|SUPERIORITY||Hodges Lehmann estimator|-1.0|||<|0.001|TWO_SIDED|95.0|-1.0|-1.0|||Wilcoxon (Mann-Whitney)|||||-1.0|-1.0|<0.001
72455679|NCT01934452|144434483|SUPERIORITY|||||||0.009|||||||Fisher Exact|||||||0.009
72455680|NCT00556478|144434561|SUPERIORITY_OR_OTHER||Ratio (over 3 months/Baseline)|3.05|||<|0.0001|TWO_SIDED|95.0|2.29|4.06|||ANCOVA|||||4.06|2.29|<0.0001
72455681|NCT00556478|144434562|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.0|||<|0.0001|TWO_SIDED|95.0|3.61|6.34|||ANCOVA|||Analysis of IPE domain ejaculatory control||6.34|3.61|<0.0001
72455682|NCT00556478|144434562|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.6|||<|0.0001|TWO_SIDED|95.0|3.3|5.84|||ANCOVA|||IPE domain sexual satisfaction||5.84|3.30|<0.0001
72455683|NCT00556478|144434562|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.5|||<|0.0001|TWO_SIDED|95.0|1.86|3.2|||ANCOVA|||IPE domain distress||3.20|1.86|<0.0001
72455684|NCT05270460|144434575|SUPERIORITY||||||<|0.05|TWO_SIDED|95.0||||Adjustment for multiple comparisons were made using Dunnett's test at the overall alpha = 0.05 significance level|ANCOVA|Fixed effects for treatment group (PCS12852 0.1 mg, PCS12852 0.5 mg, and Placebo) and type (IG or DG) and the baseline value as a continuous covariate||||||<0.05
72455685|NCT05270460|144434576|SUPERIORITY||||||<|0.05|TWO_SIDED|95.0|||||ANCOVA|Fixed effects for treatment group (PCS12852 0.1 mg, PCS12852 0.5 mg, and Placebo) and type (IG or DG) and the baseline value as a continuous covariate||||||<0.05
72455686|NCT05270460|144434577|SUPERIORITY||||||<|0.05|||||||Regression, Linear|||||||<0.05
72455687|NCT05270460|144434578|SUPERIORITY||||||<|0.05|||||||Regression, Linear|||||||<0.05
72455688|NCT05270460|144434579|SUPERIORITY||||||<|0.05|TWO_SIDED|95.0|||||ANCOVA|||||||<0.05
72455689|NCT05270460|144434580|SUPERIORITY||||||<|0.05|TWO_SIDED|95.0|||||ANCOVA|||||||<0.05
72455690|NCT05270460|144434581|SUPERIORITY||||||<|0.05|TWO_SIDED|95.0|||||ANCOVA|||||||<0.05
72455691|NCT05270460|144434582|SUPERIORITY||||||<|0.05|TWO_SIDED|95.0|||||ANCOVA|||||||<0.05
72455692|NCT05270460|144434583|SUPERIORITY||||||<|0.05|||||||Regression, Linear|||||||<0.05
72455693|NCT05270460|144434584|SUPERIORITY||||||<|0.05|||||||Regression, Linear|||||||<0.05
72455694|NCT00380250|144434585|SUPERIORITY_OR_OTHER_LEGACY|||||||0.117|||||||van Elteren nonparametric test|Adjusted for center||||||0.117
72455695|NCT00380250|144434586|SUPERIORITY_OR_OTHER_LEGACY|||||||0.006|||||||van Elteren nonparametric test|Adjusted for center||||||0.006
72455696|NCT00380250|144434587|SUPERIORITY_OR_OTHER_LEGACY|||||||0.05|||||||van Elteren nonparametric test|Adjusted for center||||||0.050
72455697|NCT00380250|144434588|SUPERIORITY_OR_OTHER_LEGACY|||||||0.159|||||||van Elteren nonparametric test|Adjusted for center||||||0.159
72455698|NCT00380250|144434589|SUPERIORITY_OR_OTHER_LEGACY|||||||0.378|||||||Cochran-Mantel-Haenszel|Stratified by pooled center||||||0.378
72455699|NCT00380250|144434590|SUPERIORITY_OR_OTHER_LEGACY|||||||0.588|||||||ANCOVA|Adjusted for clinical site||||||0.588
72455700|NCT00380250|144434591|SUPERIORITY_OR_OTHER_LEGACY|||||||0.029||||||No adjustment|Cochran-Mantel-Haenszel|Stratified by pooled center, used to test the null hypothesis of equal rates between the 2 groups vs. the alternate hypothesis of non-equality||90% statistical power to detect 70.6% improvement in response with lubiprostone||||0.029
72455701|NCT00380250|144434592|SUPERIORITY_OR_OTHER_LEGACY|||||||0.028||||||Sequential closed testing procedures were employed|Cochran-Mantel-Haenszel|Stratified by pooled center, used to test the null hypothesis of equal rates between the 2 groups vs. the alternate hypothesis of non-equality||||||0.028
72455702|NCT00380250|144434593|SUPERIORITY_OR_OTHER_LEGACY|||||||0.069||||||Sequential closed testing procedures were employed|Cochran-Mantel-Haenszel|Stratified by pooled center, used to test the null hypothesis of equal rates between the 2 groups vs. the alternate hypothesis of non-equality||||||0.069
72455703|NCT00380250|144434594|SUPERIORITY_OR_OTHER_LEGACY|||||||0.098||||||Sequential closed testing procedures were employed|Cochran-Mantel-Haenszel|Stratified by pooled center, used to test the null hypothesis of equal rates between the 2 groups vs. the alternate hypothesis of non-equality||||||0.098
72455704|NCT00380250|144434595|SUPERIORITY_OR_OTHER_LEGACY|||||||0.286|||||||van Elteren nonparametric test|Adjusted for center||||||0.286
72455705|NCT00380250|144434596|SUPERIORITY_OR_OTHER_LEGACY|||||||0.337|||||||van Elteren nonparametric test|Adjusted for center||||||0.337
72455706|NCT00380250|144434597|SUPERIORITY_OR_OTHER_LEGACY|||||||0.334|||||||van Elteren nonparametric test|Adjusted for center||||||0.334
72455707|NCT00380250|144434598|SUPERIORITY_OR_OTHER_LEGACY|||||||0.242|||||||van Elteren nonparametric test|Adjusted for center||||||0.242
72455708|NCT00380250|144434599|SUPERIORITY_OR_OTHER_LEGACY|||||||0.03|||||||van Elteren nonparametric test|Adjusted for center||||||0.030
72455709|NCT00380250|144434600|SUPERIORITY_OR_OTHER_LEGACY|||||||0.13|||||||van Elteren nonparametric test|Adjusted for center||||||0.130
72500110|NCT05817045|144530434|SUPERIORITY|adjusted for the following prognostic baseline covariates: baseline log10 nasopharyngeal viral load, ethnicity, hours since symptom onset, and baseline risk factor score|Hazard Ratio (HR)|1.02||||0.859|TWO_SIDED|95.0|0.782|1.342|||NPANCOVA||For the HR calculation Sham was taken to be the reference group, meaning a HR \> 1 is favorable for RD-X19;|NPANCOVA analysis for time to sustained resolution of COVID-19 signs and symptoms without subsequent symptom recurrence or disease progression (until the end of the study) - Secondary Analysis (FAS excluding subjects that were qPCR negative at baseline)||1.342|0.782|0.859
72500111|NCT05817045|144530436|SUPERIORITY|adjusted for the following prognostic baseline covariates: baseline log10 nasopharyngeal viral load, ethnicity, hours since symptom onset, and baseline risk factor score|Hazard Ratio (HR)|1.29||||0.017|TWO_SIDED|95.0|1.047|1.596|||NPANCOVA||For the HR calculation Sham was taken to be the reference group, meaning a HR \> 1 is favorable for RD-X19|NPANCOVA analysis for time to first of two negative SARS-CoV-2 antigen tests (with a minimum time between tests of six hours) without subsequent virologic rebound (during the subject's remaining time on study) Full Analysis Set (FAS)||1.596|1.047|0.017
72500112|NCT05817045|144530436|SUPERIORITY|adjusted for the following prognostic baseline covariates: baseline log10 nasopharyngeal viral load, ethnicity, hours since symptom onset, and baseline risk factor score|Hazard Ratio (HR)|1.33||||0.014|TWO_SIDED|95.0|1.059|1.665|||NPANCOVA||For the HR calculation Sham was taken to be the reference group, meaning a HR \> 1 is favorable for RD-X19;|NPANCOVA analysis for time to first of two negative SARS-CoV-2 antigen tests (with a minimum time between tests of six hours) without subsequent virological rebound (during the subject's remaining time on study) (Per-Protocol population)||1.665|1.059|0.014
72562940|NCT00337428|144657756|NON_INFERIORITY_OR_EQUIVALENCE|The ratio of GMTs (concomitant group / nonconcomitant group) must be greater than 0.67.|||||<|0.001||95.0|||||ANOVA|ANOVA on natural log titer with fixed effects for region, vaccination group and their interaction.||||||<0.001
72562941|NCT00337428|144657757|NON_INFERIORITY_OR_EQUIVALENCE|The ratio of GMTs (concomitant group / nonconcomitant group) must be greater than 0.67.|||||<|0.001||95.0|||||ANOVA|ANOVA on natural log titer with fixed effects for region, vaccination group and their interaction.||||||<0.001
72370430|NCT00488683|144251631|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|-0.07||||0.7||95.0||||Values from Group 1, 2 and 3 were combined for this analysis.|Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccinations and memory B cells at 12 months of age for the serogroup A||||0.70
72562942|NCT00337428|144657758|NON_INFERIORITY_OR_EQUIVALENCE|The ratio of GMTs (concomitant group / nonconcomitant group) must be greater than 0.67.|||||<|0.001||95.0|||||ANOVA|ANOVA on natural log titer with fixed effects for region, vaccination group and their interaction.||||||<0.001
72370431|NCT00488683|144251631|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|-0.13||||0.37||95.0||||Values from Group 1, 2 and 3 were combined for this analysis.|Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccinations and memory B cells at 12 months of age for the serogroup C||||0.37
72455710|NCT00380250|144434601|SUPERIORITY_OR_OTHER_LEGACY|||||||0.049|||||||van Elteren nonparametric test|Adjusted for center||||||0.049
72455711|NCT00380250|144434602|SUPERIORITY_OR_OTHER_LEGACY|||||||0.348|||||||van Elteren nonparametric test|Adjusted for center||||||0.348
72455712|NCT00380250|144434603|SUPERIORITY_OR_OTHER_LEGACY|||||||0.064|||||||van Elteren nonparametric test|Adjusted for center||||||0.064
72455713|NCT00380250|144434604|SUPERIORITY_OR_OTHER_LEGACY|||||||0.111|||||||van Elteren nonparametric test|||||||0.111
72455714|NCT00380250|144434605|SUPERIORITY_OR_OTHER_LEGACY|||||||0.144|||||||Cochran-Mantel-Haenszel|Stratified by pooled center||||||0.144
72455715|NCT00380250|144434606|SUPERIORITY_OR_OTHER_LEGACY|||||||0.168|||||||Cochran-Mantel-Haenszel|Adjusted by pooled center||||||0.168
72455716|NCT00380250|144434607|SUPERIORITY_OR_OTHER_LEGACY|||||||0.615|||||||van Elteren nonparametic test|Adjusted for center||||||0.615
72455717|NCT00380250|144434608|SUPERIORITY_OR_OTHER_LEGACY|||||||0.108|||||||van Elteren nonparametric test|||||||0.108
72455718|NCT00380250|144434609|SUPERIORITY_OR_OTHER_LEGACY|||||||0.483|||||||van Elteren nonparametric test|||||||0.483
72455719|NCT00380250|144434610|SUPERIORITY_OR_OTHER_LEGACY|||||||0.491|||||||van Elteren nonparametric test|||||||0.491
72455720|NCT00380250|144434611|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||van Elteren nonparametric test|Adjusted for center||||||<0.001
72455721|NCT00380250|144434612|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||van Elteren nonparametric test|Adjusted for center||||||<0.001
72455722|NCT00380250|144434613|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||van Elteren nonparametric test|Adjusted for center||||||<0.001
72455723|NCT02157948|144434631|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority Testing: The lower bound of the 2-sided 95% CI of the between-group difference (denosumab CP4 - denosumab CP2) in percent change from baseline in lumbar spine BMD at 12 months was compared with the non-inferiority margin of -1.44% for assessing non-inferiority.|Difference from CP2|-0.07|||<|0.001|TWO_SIDED|95.0|-0.72|0.57||One-sided p-value based on the prespecified non-inferiority margin of -1.44% for lumbar spine.|ANCOVA|||The treatment comparison was analyzed using the analysis of covariance (ANCOVA) model including treatment, baseline BMD value, machine type, and machine type-by-baseline BMD value interaction. The effect of denosumab CP4 on lumbar spine BMD at 12 months relative to the effect of denosumab CP2 was estimated by the least-squares mean of the treatment difference (denosumab CP4 - denosumab CP2) and the corresponding 2-sided 95% confidence interval (CI).||0.57|-0.72|< 0.001
72562943|NCT00337428|144657759|NON_INFERIORITY_OR_EQUIVALENCE|The ratio of GMTs (concomitant group / nonconcomitant group) must be greater than 0.67.|||||<|0.001||95.0|||||ANOVA|ANOVA on natural log titer with fixed effects for region, vaccination group and their interaction.||||||<0.001
72392286|NCT01438957|144292048|SUPERIORITY|||||||0.044|||||||Mantel Haenszel|Stratified by the anesthesia type||The closed testing procedure is used taking multiplicity into consideration, in which Dexmedetomidine 1.0 mcg/kg group, 0.5 mcg/kg group, 0.25 mcg/kg group, 0.067 mcg/kg group and the placebo group are tested in this order||||0.044
72392287|NCT01438957|144292048|SUPERIORITY|||||||0.234|||||||Mantel Haenszel|Stratified by the anesthesia type||||||0.234
72392288|NCT01438957|144292049|SUPERIORITY|||||||0.729|||||||Mantel Haenszel|Stratified by the anesthesia type||The closed testing procedure is used taking multiplicity into consideration, in which Dexmedetomidine 1.0 mcg/kg group, 0.5 mcg/kg group, 0.25 mcg/kg group, 0.067 mcg/kg group and the placebo group are tested in this order||||0.729
72392289|NCT01438957|144292050|SUPERIORITY|||||||0.082|||||||Mantel Haenszel|Stratified by the anesthesia type||The closed testing procedure is used taking multiplicity into consideration, in which Dexmedetomidine 1.0 mcg/kg group, 0.5 mcg/kg group, 0.25 mcg/kg group, 0.067 mcg/kg group and the placebo group are tested in this order||||0.082
72392290|NCT01438957|144292051|SUPERIORITY|||||||0.451|||||||Mantel Haenszel|Stratified by the anesthesia type||The closed testing procedure is used taking multiplicity into consideration, in which Dexmedetomidine 1.0 mcg/kg group, 0.5 mcg/kg group, 0.25 mcg/kg group, 0.067 mcg/kg group and the placebo group are tested in this order||||0.451
72392291|NCT01438957|144292052|SUPERIORITY|||||||0.873|||||||Mantel Haenszel|Stratified by the anesthesia type||The closed testing procedure is used taking multiplicity into consideration, in which Dexmedetomidine 1.0 mcg/kg group, 0.5 mcg/kg group, 0.25 mcg/kg group, 0.067 mcg/kg group and the placebo group are tested in this order||||0.873
72392292|NCT01438957|144292053|SUPERIORITY|||||||0.374|||||||Mantel Haenszel|Stratified by the anesthesia type||The closed testing procedure is used taking multiplicity into consideration, in which Dexmedetomidine 1.0 mcg/kg group, 0.5 mcg/kg group, 0.25 mcg/kg group, 0.067 mcg/kg group and the placebo group are tested in this order||||0.374
72392293|NCT02548650|144292063|NON_INFERIORITY|Under the null hypothesis that the mean aggregation between dual and triple therapy is not equal to 0 and a common standard deviation of 13%, a sample size of 28 patients per group with a valid primary end point time point allowed for the 95% confidence interval (CI) to stay within ± 10% with a 80% power and a two-sided alpha=0.05.|Mean Difference (Net)|12.0|||>|0.05|TWO_SIDED|95.0|3.0|21.0|||ANOVA|||The primary end point of our study was the comparison of CAT-induced MPA measured by LTA between triple (vorapaxar plus DAPT) and dual (vorapaxar plus clopidogrel) therapy. We hypothesized that dual therapy would be non-inferior to triple therapy after 30±5 days of treatment||21|3|>0.05
72392294|NCT01539538|144292065|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin of - 15% for lower boundary of 95% confidence interval|difference in proportion|12.9|||<|0.001|TWO_SIDED|95.0|3.69|22.11|||one-sided, z-test|||||22.11|3.69|<0.001
72392295|NCT01539538|144292065|SUPERIORITY_OR_OTHER||Difference in proportion|12.9||||0.007|TWO_SIDED|95.0|||||t-test, 2 sided|||||||0.007
72562944|NCT00779402|144657768|OTHER||Hazard Ratio (HR)|0.997||||0.65|TWO_SIDED|95.0|0.693|1.433|||Log Rank|Log Rank Test (two sided) stratified by Gleason Score and Radiation Therapy||||1.433|0.693|0.65
72392296|NCT01727297|144292103|SUPERIORITY||Hazard Ratio (HR)|1.08|||<|0.001|TWO_SIDED|95.0|1.05|1.11||All predictors were tested in a multivariable Cox proportional hazards regression model; the results were not adjusted for multiple comparisons. Age was treated as a continuous variable in years.|Regression, Cox||The hazard ratio represented the effect of a one year increase in age on a patient's risk of developing AF. Descriptive statistics (mean±standard deviation) for age were 75.7±7.9 years among patients with AF, and 69.4±10.0 among patients without AF|The null hypothesis was that age did not influence a patient's risk of experiencing AF (it's coefficient in a Cox proportional hazards model was 0).||1.11|1.05|< 0.001
72392297|NCT01727297|144292103|SUPERIORITY||Hazard Ratio (HR)|1.04||||0.02|TWO_SIDED|95.0|1.01|1.08||All predictors were tested in a multivariable Cox proportional hazards regression model; the results were not adjusted for multiple comparisons. BMI was treated as a continuous variable.|Regression, Cox||The hazard ratio represented the effect of a one unit increase in BMI on a patient's risk of developing AF. Descriptive statistics (mean ± standard deviation) for BMI were 31.0 ± 6.6 among patients with AF, and 31.2 ± 6.4 among patients without AF|The null hypothesis was that body mass index (BMI) did not influence a patient's risk of experiencing AF (it's coefficient in a Cox proportional hazards model was 0).||1.08|1.01|0.02
72392298|NCT01727297|144292103|SUPERIORITY||Hazard Ratio (HR)|1.11||||0.56|TWO_SIDED|95.0|0.77|1.61||All predictors were tested in a multivariable Cox proportional hazards regression model; the results were not adjusted for multiple comparisons.|Regression, Cox||The hazard ratio represented the effect of being male on a patient's risk of developing AF.|The null hypothesis was that gender did not influence a patient's risk of experiencing AF (it's coefficient for being male in a Cox proportional hazards model was 0).||1.61|0.77|0.56
72392299|NCT01727297|144292103|SUPERIORITY||Hazard Ratio (HR)|1.09||||0.66|TWO_SIDED|95.0|0.74|1.59||All predictors were tested in a multivariable Cox proportional hazards regression model; the results were not adjusted for multiple comparisons.|Regression, Cox||The hazard ratio represented the effect of having diabetes on a patient's risk of developing AF.|The null hypothesis was that diabetes did not influence a patient's risk of experiencing AF (it's coefficient in a Cox proportional hazards model was 0).||1.59|0.74|0.66
72392300|NCT01727297|144292103|SUPERIORITY||Hazard Ratio (HR)|1.08||||0.73|TWO_SIDED|95.0|0.69|1.69||All predictors were tested in a multivariable Cox proportional hazards regression model; the results were not adjusted for multiple comparisons.|Regression, Cox||The hazard ratio represented the effect of having heart failure on a patient's risk of developing AF.|The null hypothesis was that heart failure did not influence a patient's risk of experiencing AF (it's coefficient in a Cox proportional hazards model was 0).||1.69|0.69|0.73
72562945|NCT01028911|144657815|SUPERIORITY_OR_OTHER||Adjusted Geometric Means Ratio|128.4|||||TWO_SIDED|90.0|75.9|217.21||||||Day 30: Natural log transformed AUCtau of donepezil was analyzed using a mixed effect model with sequence, day and treatment as fixed effects and participant within sequence as a random effect.The adjusted mean differences and 90% confidence intervals for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% confidence intervals for the ratios. Values were back-transformed from the log scale.||217.21|75.90|
72455724|NCT02157948|144434631|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence Testing: The lower and upper bounds of the same 2-sided 95% CI of the between-group difference were compared with the equivalence margin of ±1.44% for assessing equivalence.|Difference from CP2|-0.07|||<|0.001|TWO_SIDED|95.0|-0.72|0.57||Two-sided p-value based on the prespecified equivalence margin of ±1.44% for lumbar spine.|ANCOVA|||The treatment comparison was analyzed using the analysis of covariance (ANCOVA) model including treatment, baseline BMD value, machine type, and machine type-by-baseline BMD value interaction. The effect of denosumab CP4 on lumbar spine BMD at 12 months relative to the effect of denosumab CP2 was estimated by the least-squares mean of the treatment difference (denosumab CP4 - denosumab CP2) and the corresponding 2-sided 95% confidence interval (CI).||0.57|-0.72|< 0.001
72455725|NCT01638000|144434656|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was concluded if the lower limit of the 95% CI for difference of adjusted change from baseline between solifenacin 5 mg and mirabegron 50 mg was \> -0.20. Differences of adjusted means were calculated by subtracting the adjusted mean of mirabegron 50 mg from the adjusted mean of solifenacin 5 mg. Overall power calculation was 80% for a 1-sided test and significance level of 0.025.|least squares mean difference|-0.18|STANDARD_ERROR_OF_MEAN|0.124||0.15|TWO_SIDED|95.0|-0.42|0.06||If p\<0.05, this indicated superiority in favor of the treatment group with the largest improvement at specified visit.|ANCOVA|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region as fixed factors and baseline as a covariate||The non-inferiority of mirabegron vs. solifencacin on the change from baseline to final visit in the mean number of micturitions per 24 hours.||0.06|-0.42|0.15
72455726|NCT01638000|144434657|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.53||||0.03|TWO_SIDED|95.0|1.04|2.25||If P \<0.05, this indicates superiority in favor of the treatment group with the smallest percentage of participants with at least 1 TEAE of dry mouth, constipation or blurred vision during the double-blind period at the final visit.|Regression, Logistic|Included treatment group, sex, age group (\< 65, ≥ 65), number of prior antimuscarinics (1, ≥ 2) and geographic region as factors.||Difference vs Mirabegron. Differences of the percentages were calculated by subtracting the percentage of mirabegron 50 mg group from the percentage of solifenacin 5 mg group.||2.25|1.04|0.030
72562946|NCT01028911|144657816|SUPERIORITY_OR_OTHER||Adjusted Geometric Means Ratio|119.82|||||TWO_SIDED|90.0|75.9|189.16||||||Day 30: Natural log transformed AUCtau of donepezil was analyzed using a mixed effect model with sequence, day and treatment as fixed effects and participant within sequence as a random effect.The adjusted mean differences and 90% confidence intervals for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% confidence intervals for the ratios. Values were back-transformed from the log scale.||189.16|75.90|
72455727|NCT01638000|144434658|SUPERIORITY_OR_OTHER_LEGACY||least squares mean difference|0.04|STANDARD_ERROR_OF_MEAN|0.117||0.71|TWO_SIDED|95.0|-0.19|0.27||If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|ANCOVA|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region as fixed factors and baseline as a covariate||Week 4 Difference vs. Mirabegron. Differences of adjusted means were calculated by subtracting the adjusted mean of mirabegron 50 mg from the adjusted mean of solifenacin 5 mg.||0.27|-0.19|0.71
72455728|NCT01638000|144434658|SUPERIORITY_OR_OTHER_LEGACY||least squares mean difference|-0.23|STANDARD_ERROR_OF_MEAN|0.119||0.053|TWO_SIDED|95.0|-0.47|0.0||If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|ANCOVA|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region as fixed factors and baseline as a covariate||Week 8 Difference vs. Mirabegron. Differences of adjusted means were calculated by subtracting the adjusted mean of mirabegron 50 mg from the adjusted mean of solifenacin 5 mg.||0.00|-0.47|0.053
72455729|NCT01638000|144434658|SUPERIORITY_OR_OTHER_LEGACY||least squares mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.125||0.12|TWO_SIDED|95.0|-0.44|0.05||If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|ANCOVA|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region as fixed factors and baseline as a covariate||Week 12 Difference vs. Mirabegron. Differences of adjusted means were calculated by subtracting the adjusted mean of mirabegron 50 mg from the adjusted mean of solifenacin 5 mg.||0.05|-0.44|0.12
72455730|NCT01638000|144434659|SUPERIORITY_OR_OTHER_LEGACY||Rate ratio|0.9||||0.33|TWO_SIDED|95.0|0.73|1.11||If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|Poisson regression|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region and baseline as covariates.||Week 4 Rate Ratio vs. Mirabegron.||1.11|0.73|0.33
72562947|NCT00530348|144657823|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.7||||0.2173|TWO_SIDED|95.0|0.4|1.23||Hochberg method was used to adjust for the two co-primary outcomes.|Cox Proportional Hazards Regression|||Cox proportional hazards (PH) regression model with robust variance estimation using treatment group and geographic region as covariates was used.||1.23|0.40|0.2173
72562948|NCT00530348|144657824|SUPERIORITY_OR_OTHER||Rate ratio|0.45|||<|0.0001|TWO_SIDED|95.0|0.32|0.63||Hochberg method was used to adjust for the two co-primary outcomes.|Proportional means regression|||Proportional means regression model with robust variance estimation and covariate adjustment for geographic region was used.||0.63|0.32|<0.0001
72562949|NCT00530348|144657825|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.45|||<|0.0001|TWO_SIDED|95.0|0.33|0.61|||Cox Proportional Hazards Regression|||Cox PH regression model with robust variance estimation, covariate adjustment for geographic region, was used. Secondary endpoints were analyzed sequentially as: Proportion of participants relapse free at Year 2, Change from baseline in EDSS, Percent change from Baseline in magnetic resonance imaging-T2 hyperintense lesion volume at Year 2, Acquisition of disability measured by multiple sclerosis functional composite. Each endpoint could only be formally tested if prior endpoint was significant.||0.61|0.33|<0.0001
72370432|NCT00488683|144251631|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|0.66|||<|0.0001||95.0||||Values from Group 1, 2 and 3 were combined for this analysis.|Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccinations and memory B cells at 12 months of age for the serogroup W-135||||<0.0001
72370433|NCT00488683|144251631|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|0.9|||<|0.0001||95.0||||Values from Group 1, 2 and 3 were combined for this analysis.|Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccinations and memory B cells at 12 months of age for the serogroup Y||||<0.0001
72455731|NCT01638000|144434659|SUPERIORITY_OR_OTHER_LEGACY||Rate ratio|0.84||||0.21|TWO_SIDED|95.0|0.64|1.1||If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|Poisson regression|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region and baseline as covariates.||Week 8 Rate Ratio vs. Mirabegron.||1.10|0.64|0.21
72455732|NCT01638000|144434659|SUPERIORITY_OR_OTHER_LEGACY||Rate ratio|0.97||||0.83|TWO_SIDED|95.0|0.71|1.32||If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|Poisson regression|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region and baseline as covariates||Week 12 Rate Ratio vs. Mirabegron.||1.32|0.71|0.83
72455733|NCT01638000|144434659|SUPERIORITY_OR_OTHER_LEGACY||Rate ratio|0.92||||0.57|TWO_SIDED|95.0|0.68|1.24||If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|Poisson regression|Treatment group, gender, age group (\<65,≥ 65), number of prior antimuscarinics (1, ≥2), geographic region and baseline as covariates.||Final Visit Rate Ratio vs. Mirabegron||1.24|0.68|0.57
72562950|NCT00530348|144657826|SUPERIORITY_OR_OTHER|||||||0.4188|||||||Wei-Lachin|||The analysis was performed using Wei-Lachin method for non-parametric analysis of repeated measures. Secondary endpoints were analyzed sequentially as: Proportion of participants relapse free at Year 2, Change from baseline in EDSS, Percent change from Baseline in magnetic resonance imaging-T2 hyperintense lesion volume at Year 2, Acquisition of disability measured by multiple sclerosis functional composite. Each endpoint could only be formally tested if prior endpoint was significant.||||0.4188
72562951|NCT00530348|144657827|SUPERIORITY_OR_OTHER|||||||0.0115|||||||Wei-Lachin|||Change at Year 2: analysis was performed using Wei-Lachin method for non-parametric analysis of repeated measures. Secondary endpoints were analyzed sequentially as: Proportion of participants relapse free at Year 2, Change from baseline in EDSS, Percent change from Baseline in magnetic resonance imaging-T2 hyperintense lesion volume at Year 2, Acquisition of disability measured by MSFC. Each endpoint could only be formally tested if prior endpoint was significant.||||0.0115
72455734|NCT01638000|144434660|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.08|STANDARD_ERROR_OF_MEAN|0.089||0.36|TWO_SIDED|95.0|-0.25|0.1||If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|ANCOVA|From stratified rank ANCOVA analysis.||Week 4 Difference vs. Mirabegron. Differences of adjusted means were calculated by subtracting the adjusted mean of mirabegron 50 mg from the adjusted mean of solifenacin 5 mg.||0.10|-0.25|0.36
72455735|NCT01638000|144434660|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.22|STANDARD_ERROR_OF_MEAN|0.13||0.12|TWO_SIDED|95.0|-0.48|0.03||If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|ANCOVA|From the stratified rank ANCOVA analysis.||Week 8 Difference vs. Mirabegron. Differences of adjusted means were calculated by subtracting the adjusted mean of mirabegron 50 mg from the adjusted mean of solifenacin 5 mg.||0.03|-0.48|0.12
72455736|NCT01638000|144434660|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.25|STANDARD_ERROR_OF_MEAN|0.163||0.47|TWO_SIDED|95.0|-0.57|0.07||If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|ANCOVA|From the stratified rank ANCOVA analysis.||Week 12 Difference vs. Mirabegron. Difference of the adjusted mean is calculated by subtracting the adjusted mean of mirabegron from the adjusted mean of solifenacin.||0.07|-0.57|0.47
72455737|NCT01638000|144434661|SUPERIORITY_OR_OTHER_LEGACY||Rate ratio|0.92||||0.44|TWO_SIDED|95.0|0.74|1.14||If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|Poisson regression|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region and baseline as covariates.||Week 4 Rate Ratio vs. Mirabegron||1.14|0.74|0.44
72455738|NCT01638000|144434661|SUPERIORITY_OR_OTHER_LEGACY||Rate ratio|0.79||||0.11|TWO_SIDED|95.0|0.6|1.06||If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|Poisson regression|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region and baseline as covariates||Week 8 Rate Ratio vs. Mirabegron||1.06|0.60|0.11
72455739|NCT01638000|144434661|SUPERIORITY_OR_OTHER_LEGACY||Rate ratio|1.05||||0.78|TWO_SIDED|95.0|0.76|1.45||If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|Poisson regression|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region and baseline as covariates||Week 12 Rate Ratio vs. Mirabegron||1.45|0.76|0.78
72455740|NCT01638000|144434661|SUPERIORITY_OR_OTHER_LEGACY||Rate ratio|0.97||||0.85|TWO_SIDED|95.0|0.71|1.33||If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|Poisson regression|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region and baseline as covariates||Final Visit Rate Ratio vs. Mirabegron||1.33|0.71|0.85
72562952|NCT00530348|144657828|SUPERIORITY_OR_OTHER|||||||0.308|TWO_SIDED||||||Ranked ANCOVA|||Ranked ANCOVA models with covariate adjustment for geographic region and baseline T2 lesion volume was used. Secondary endpoints were analyzed sequentially as: Proportion of participants relapse free at Year 2, Change from baseline in EDSS, Percent change from Baseline in magnetic resonance imaging-T2 hyperintense lesion volume at Year 2, Acquisition of disability measured by multiple sclerosis functional composite. Each endpoint could only be formally tested if prior endpoint was significant.||||0.3080
72562953|NCT01201486|144657875|SUPERIORITY_OR_OTHER||Percentage Sensitivity|23.0|||||TWO_SIDED||||||Percentage Sensitivity|||||||
72562954|NCT03604549|144657876|SUPERIORITY||Risk Ratio (RR)|0.44||||0.1|TWO_SIDED|95.0|0.16|1.25|||Chi-squared||Lipiodol UF is the numerator and Saline is the denominator for RR|||1.25|0.16|0.10
72562955|NCT03604549|144657877|SUPERIORITY||Mean Difference (Final Values)|0.04||||0.96|TWO_SIDED|95.0|-1.59|1.68|||t-test, 2 sided||Difference reported as Lipiodol UF - Saline|||1.68|-1.59|0.96
72562956|NCT02020967|144657906|OTHER||Odds Ratio (OR)|7.34||||0.0196|TWO_SIDED|95.0|1.38|39.11|||Regression, Logistic|||Predictor variable: Lips enlargement||39.11|1.38|0.0196
72622491|NCT02544763|144774966|SUPERIORITY|Model includes the total number of seizures as a response variable and age group, time (Baseline and treatment period), treatment and treatment by time interaction as fixed effects and participant as a random effect. The log transformed number of days seizures were reported by period is included as an offset.|Percentage reduction|0.519|||||TWO_SIDED|95.0|0.447|0.602||||||||0.602|0.447|
72500113|NCT05817045|144530436|SUPERIORITY|adjusted for the following prognostic baseline covariates: baseline log10 nasopharyngeal viral load, ethnicity, hours since symptom onset, and baseline risk factor score|Hazard Ratio (HR)|1.35||||0.007|TWO_SIDED|95.0|1.086|1.69|||NPANCOVA||For the HR calculation Sham was taken to be the reference group, meaning a HR \> 1 is favorable for RD-X19|NPANCOVA analysis for time to first of two negative SARS-CoV-2 antigen tests (with a minimum time between tests of six hours) without subsequent virological rebound (during the subject's remaining time on study) - Secondary analysis - (FAS excluding subjects that were qPCR negative at baseline)||1.690|1.086|0.007
72455741|NCT01638000|144434662|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.02|STANDARD_ERROR_OF_MEAN|0.081||0.66|TWO_SIDED|95.0|-0.18|0.14||If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|ANCOVA|From stratified rank ANCOVA analysis.||Week 4 Difference vs. Mirabegron. Differences of adjusted means were calculated by subtracting the adjusted mean of mirabegron 50 mg from the adjusted mean of solifenacin 5 mg.||0.14|-0.18|0.66
72455742|NCT01638000|144434662|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.17|STANDARD_ERROR_OF_MEAN|0.07||0.17|TWO_SIDED|95.0|-0.31|-0.03||If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|ANCOVA|From the stratified rank ANCOVA analysis.||Week 8 Difference vs. Mirabegron. Differences of adjusted means were calculated by subtracting the adjusted mean of mirabegron 50 mg from the adjusted mean of solifenacin 5 mg.||-0.03|-0.31|0.17
72500114|NCT05817045|144530436|SUPERIORITY|SARS-CoV-2 rapid antigen test type: Flowflex|Cox Proportional Hazard|1.46|||||TWO_SIDED|95.0|1.064|1.997|||||For the HR calculation Sham was taken to be the reference group, meaning a HR \> 1 is favorable for RD-X19|Cox proportional hazards model for time to first of two negative SARS-CoV-2 antigen tests (with a minimum time between tests of six hours) without subsequent virological rebound (during the subject's remaining time on study) (FAS)||1.997|1.064|
72500115|NCT05817045|144530436|SUPERIORITY|SARS-CoV-2 rapid antigen test type: BinaxNOW|Cox Proportional Hazard|1.12|||||TWO_SIDED|95.0|0.801|1.561|||||For the HR calculation Sham was taken to be the reference group, meaning a HR \> 1 is favorable for RD-X19|Subgroup Analysis - Cox proportional hazards model for time to first of two negative SARS-CoV-2 antigen tests (with a minimum time between tests of six hours) without subsequent virological rebound (during the subject's remaining time on study) (FAS)||1.561|0.801|
72455743|NCT01638000|144434662|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.11|STANDARD_ERROR_OF_MEAN|0.066||0.66|TWO_SIDED|95.0|-0.24|0.02||If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|ANCOVA|From the stratified rank ANCOVA analysis.||Week 12 Difference vs. Mirabegron. Differences of adjusted means were calculated by subtracting the adjusted mean of mirabegron 50 mg from the adjusted mean of solifenacin 5 mg.||0.02|-0.24|0.66
72455744|NCT01638000|144434663|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.13|STANDARD_ERROR_OF_MEAN|0.16||0.43|TWO_SIDED|95.0|-0.44|0.19||If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|ANCOVA|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region as fixed factors and baseline as a covariate||Week 4 Difference vs. Mirabegron. Differences of adjusted means were calculated by subtracting the adjusted mean of mirabegron 50 mg from the adjusted mean of solifenacin 5 mg.||0.19|-0.44|0.43
72455745|NCT01638000|144434663|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.35|STANDARD_ERROR_OF_MEAN|0.157||0.027|TWO_SIDED|95.0|-0.66|-0.04||If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|ANCOVA|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region as fixed factors and baseline as a covariate||Week 8 Difference vs. Mirabegron. Differences of adjusted means were calculated by subtracting the adjusted mean of mirabegron 50 mg from the adjusted mean of solifenacin 5 mg.||-0.04|-0.66|0.027
72455746|NCT01638000|144434663|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.32|STANDARD_ERROR_OF_MEAN|0.164||0.053|TWO_SIDED|95.0|-0.64|0.0|||ANCOVA|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region as fixed factors and baseline as a covariate||Week 12 Difference vs. Mirabegron. Differences of adjusted means were calculated by subtracting the adjusted mean of mirabegron 50 mg from the adjusted mean of solifenacin 5 mg.||0.00|-0.64|0.053
72455747|NCT01638000|144434663|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.23|STANDARD_ERROR_OF_MEAN|0.163||0.16|TWO_SIDED|95.0|-0.55|0.09||If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|ANCOVA|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region as fixed factors and baseline as a covariate||Final Visit Difference vs. Mirabegron. Differences of adjusted means were calculated by subtracting the adjusted mean of mirabegron 50 mg from the adjusted mean of solifenacin 5 mg.||0.09|-0.55|0.16
72455748|NCT01638000|144434664|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.023||0.99|TWO_SIDED|95.0|-0.05|0.05||If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|ANCOVA|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region as fixed factors and baseline as a covariate||Week 4 Difference vs. Mirabegron. Differences of adjusted means were calculated by subtracting the adjusted mean of mirabegron 50 mg from the adjusted mean of solifenacin 5 mg.||0.05|-0.05|0.99
72455749|NCT01638000|144434664|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.02|STANDARD_ERROR_OF_MEAN|0.027||0.47|TWO_SIDED|95.0|-0.07|0.03||If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|ANCOVA|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region as fixed factors and baseline as a covariate||Week 8 Difference vs. Mirabegron. Differences of adjusted means were calculated by subtracting the adjusted mean of mirabegron 50 mg from the adjusted mean of solifenacin 5 mg.||0.03|-0.07|0.47
72562957|NCT02508116|144657949|SUPERIORITY||Odds Ratio (OR)|1.6||||0.03|TWO_SIDED|95.0|1.07|2.42|||Regression, Logistic|||The sample size calculation was based on two factors: 1) the rate of pre-study prasugrel/ticagrelor use (\~20%) and 2) anticipated increase in prasugrel/ticagrelor prescribing based on the frequency CYP2C19 LOF variants (\~30-35%). We estimated a 15% difference in the use of prasugrel/ticagrelor in the two groups (35% in the genotyped group and 20% in the control group). A sample size of 138 per group (a total of 276) would provide 80% power at an alpha level of 0.05 to detect this difference.||2.42|1.07|0.03
72500116|NCT02148029|144530439|SUPERIORITY||Mean Difference (Net)|1.0|STANDARD_ERROR_OF_MEAN|1.0||0.34|TWO_SIDED|95.0|-1.1|3.1|||t-test, 2 sided||Mean difference = Exercise - Control|||3.1|-1.1|0.34
72500117|NCT02148029|144530440|SUPERIORITY||Mean Difference (Net)|0.5|STANDARD_ERROR_OF_MEAN|3.5||0.89|TWO_SIDED|95.0|-7.1|8.0|||t-test, 2 sided||Mean difference = Exercise - Control|||8.0|-7.1|0.89
72562958|NCT02508116|144657951|SUPERIORITY|||||||0.27|||||||Log Rank|||The incidence of first MACE between the groups were compared by use of Kaplan-Meier estimators; statistical tests were based on log-rank tests.||||0.27
72562959|NCT02630316|144657953|SUPERIORITY||Hodges-Lehmann|21.0||||0.0043|TWO_SIDED|95.0|7.0|37.0||p-value is obtained from nonparametric ANCOVA adjusted for Baseline 6MWD category.|ANCOVA|||||37.0|7.0|0.0043
72562960|NCT02630316|144657954|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
72562961|NCT02630316|144657955|SUPERIORITY||Hazard Ratio (HR)|0.61||||0.041|TWO_SIDED|95.0|0.4|0.92||p-value is calculated with log-rank test stratified by baseline 6MWD category.|Log Rank||p-value was 0.0202 for the proportional hazard model. Hazard ratio, 95% confidence interval (CI), and p-values are calculated with proportional hazards model with treatment and Baseline 6MWD (continuous) as explanatory variables.|||0.92|0.40|0.0410
72562962|NCT02630316|144657956|SUPERIORITY||Hodges-Lehmann|20.0||||0.0041|TWO_SIDED|95.0|7.0|34.0||p-value is obtained from nonparametric ANCOVA adjusted for Baseline 6MWD category|ANCOVA|||||34.0|7.0|0.0041
72562963|NCT02630316|144657957|SUPERIORITY||Hodges-Lehmann|15.0||||0.0432|TWO_SIDED|95.0|0.0|29.0||p-value is obtained from nonparametric ANCOVA adjusted for Baseline 6MWD category.|ANCOVA|||||29.0|0.0|0.0432
72392301|NCT01727297|144292103|SUPERIORITY||Hazard Ratio (HR)|1.23||||0.58|TWO_SIDED|95.0|0.58|2.6||All predictors were tested in a multivariable Cox proportional hazards regression model; the results were not adjusted for multiple comparisons.|Regression, Cox||The hazard ratio represented the effect of having hypertension on a patient's risk of developing AF.|The null hypothesis was that hypertension did not influence a patient's risk of experiencing AF (it's coefficient in a Cox proportional hazards model was 0).||2.60|0.58|0.58
72392302|NCT01727297|144292103|SUPERIORITY||Hazard Ratio (HR)|0.92||||0.65|TWO_SIDED|95.0|0.64|1.32||All predictors were tested in a multivariable Cox proportional hazards regression model; the results were not adjusted for multiple comparisons.|Regression, Cox||The hazard ratio represented the effect of having renal impairment on a patient's risk of developing AF.|The null hypothesis was that renal impairment did not influence a patient's risk of experiencing AF (it's coefficient in a Cox proportional hazards model was 0).||1.32|0.64|0.65
72392303|NCT01727297|144292103|SUPERIORITY||Hazard Ratio (HR)|0.73||||0.22|TWO_SIDED|95.0|0.45|1.2||All predictors were tested in a multivariable Cox proportional hazards regression model; the results were not adjusted for multiple comparisons.|Regression, Cox||The hazard ratio represented the effect of having COPD on a patient's risk of developing AF.|The null hypothesis was that Chronic obstructive pulmonary disease (COPD) did not influence a patient's risk of experiencing AF (it's coefficient in a Cox proportional hazards model was 0).||1.20|0.45|0.22
72392304|NCT01727297|144292103|SUPERIORITY||Hazard Ratio (HR)|0.86||||0.53|TWO_SIDED|95.0|0.54|1.38||All predictors were tested in a multivariable Cox proportional hazards regression model; the results were not adjusted for multiple comparisons.|Regression, Cox||The hazard ratio represented the effect of having a prior stroke (more than one year pre-device implant) on a patient's risk of developing AF.|The null hypothesis was that prior stroke more than one year pre-device implant did not influence a patient's risk of experiencing AF (it's coefficient in a Cox proportional hazards model was 0).||1.38|0.54|0.53
72392305|NCT01727297|144292103|SUPERIORITY||Hazard Ratio (HR)|0.78||||0.21|TWO_SIDED|95.0|0.53|1.15||All predictors were tested in a multivariable Cox proportional hazards regression model; the results were not adjusted for multiple comparisons.|Regression, Cox||The hazard ratio represented the effect of having coronary artery disease on a patient's risk of developing AF.|The null hypothesis was that coronary artery disease did not influence a patient's risk of experiencing AF (it's coefficient in a Cox proportional hazards model was 0).||1.15|0.53|0.21
72392306|NCT01727297|144292103|SUPERIORITY||Hazard Ratio (HR)|0.72||||0.19|TWO_SIDED|95.0|0.45|1.17||All predictors were tested in a multivariable Cox proportional hazards regression model; the results were not adjusted for multiple comparisons.|Regression, Cox||The hazard ratio represented the effect of having sleep apnea on a patient's risk of developing AF.|The null hypothesis was that sleep apnea did not influence a patient's risk of experiencing AF (it's coefficient in a Cox proportional hazards model was 0).||1.17|0.45|0.19
72392307|NCT01727297|144292103|SUPERIORITY||Hazard Ratio (HR)|1.97||||0.16|TWO_SIDED|95.0|0.76|5.14||All predictors were tested in a multivariable Cox proportional hazards regression model; the results were not adjusted for multiple comparisons.|Regression, Cox||The hazard ratio represented the effect of having a family history of AF on a patient's risk of developing AF.|The null hypothesis was that family history of AF did not influence a patient's risk of experiencing AF (it's coefficient in a Cox proportional hazards model was 0).||5.14|0.76|0.16
72392308|NCT01727297|144292103|SUPERIORITY||Hazard Ratio (HR)|0.89||||0.63|TWO_SIDED|95.0|0.56|1.43||All predictors were tested in a multivariable Cox proportional hazards regression model; the results were not adjusted for multiple comparisons.|Regression, Cox||The hazard ratio represented the effect of having vascular disease on a patient's risk of developing AF.|The null hypothesis was that vascular disease did not influence a patient's risk of experiencing AF (it's coefficient in a Cox proportional hazards model was 0).||1.43|0.56|0.63
72500118|NCT02148029|144530441|SUPERIORITY||Mean Difference (Net)|-5.8|STANDARD_ERROR_OF_MEAN|7.2||0.43|TWO_SIDED|95.0|-20.3|8.4|||t-test, 2 sided||Mean difference = Exercise - Control|Note that this analysis uses only 1 of the 8 SF-36 domain scores, the Physical Functioning (PF) domain score.||8.4|-20.3|0.43
72500119|NCT02148029|144530441|SUPERIORITY||Mean Difference (Net)|5.0|STANDARD_ERROR_OF_MEAN|3.3||0.13|TWO_SIDED|95.0|-1.6|11.6|||t-test, 2 sided||Mean difference = Exercise - Control|Note that this analysis uses only 1 of the 8 SF-36 domain scores, the Role limitations due to Physical health problems (RP) domain score.||11.6|-1.6|0.13
72562964|NCT00559364|144657962|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||Analysis of covariance (ANCOVA) model using treatment group and pooled site as fixed effects and wash-out phase CFA% value as covariate was used.||||<0.0001
72562965|NCT02578745|144657965|SUPERIORITY||Risk Ratio (RR)|1.67||||0.72|TWO_SIDED|95.0|0.42|6.67|||Chi-squared|||||6.67|.42|0.72
72562966|NCT02578745|144657966|SUPERIORITY||Risk Ratio (RR)|1.67||||0.72|TWO_SIDED|95.0|0.42|6.67|||Chi-squared|||||6.67|.42|0.72
72500120|NCT02148029|144530441|SUPERIORITY||Mean Difference (Net)|2.7|STANDARD_ERROR_OF_MEAN|2.8||0.33|TWO_SIDED|95.0|-2.8|8.2|||t-test, 2 sided||Mean difference = Exercise - Control|Note that this analysis uses only 1 of the 8 SF-36 domain scores, the Role limitations due to mental health or Emotional problems (RE) domain score.||8.2|-2.8|0.33
72392309|NCT02042183|144292105|OTHER|||||||0.1609||||||Cochran-Mantel-Haenszel (CMH) test stratified by baseline spontaneous bowel movement (SBM) frequency (\<1.5 or ≥1.5)|Cochran-Mantel-Haenszel|||||||0.1609
72500121|NCT02148029|144530441|SUPERIORITY||Mean Difference (Net)|5.6|STANDARD_ERROR_OF_MEAN|7.1||0.43|TWO_SIDED|95.0|-8.7|20.0|||t-test, 2 sided||Mean difference = Exercise - Control|Note that this analysis uses only 1 of the 8 SF-36 domain scores, the energy/fatigue/Vitality (VT) domain score.||20.0|-8.7|0.43
72500122|NCT02148029|144530441|SUPERIORITY||Mean Difference (Net)|-2.6|STANDARD_ERROR_OF_MEAN|5.6||0.64|TWO_SIDED|95.0|-13.8|8.6|||t-test, 2 sided||Mean difference = Exercise - Control|Note that this analysis uses only 1 of the 8 SF-36 domain scores, the Mental Health/emotional well-being (MH) domain score.||8.6|-13.8|0.64
72500123|NCT02148029|144530441|SUPERIORITY||Mean Difference (Net)|-3.9|STANDARD_ERROR_OF_MEAN|8.3||0.64|TWO_SIDED|95.0|-20.5|12.8|||t-test, 2 sided||Mean difference = Exercise - Control|Note that this analysis uses only 1 of the 8 SF-36 domain scores, the Social Functioning (SF) domain score.||12.8|-20.5|0.64
72500124|NCT02148029|144530441|SUPERIORITY||Mean Difference (Net)|9.5|STANDARD_ERROR_OF_MEAN|10.1||0.35|TWO_SIDED|95.0|-10.7|29.7|||t-test, 2 sided||Mean difference = Exercise - Control|Note that this analysis uses only 1 of the 8 SF-36 domain scores, the Bodily Pain (BP) domain score.||29.7|-10.7|0.35
72500125|NCT02148029|144530441|SUPERIORITY||Mean Difference (Net)|-3.5|STANDARD_ERROR_OF_MEAN|5.3||0.5|TWO_SIDED|95.0|-14.1|7.0|||t-test, 2 sided||Mean difference = Exercise - Control|Note that this analysis uses only 1 of the 8 SF-36 domain scores, the General Health (GH) domain score.||7.0|-14.1|0.50
72500126|NCT02148029|144530442|SUPERIORITY||Mean Difference (Net)|-33.9|STANDARD_ERROR_OF_MEAN|30.1||0.27|TWO_SIDED|95.0|-95.5|27.7|||t-test, 2 sided||Mean difference = Exercise - Control|||27.7|-95.5|0.27
72500127|NCT02148029|144530443|SUPERIORITY||Mean Difference (Net)|-1.6|STANDARD_ERROR_OF_MEAN|0.9||0.07|TWO_SIDED|95.0|-3.4|0.1|||t-test, 2 sided||Mean difference = Reflux - No reflux|||0.1|-3.4|0.07
72500128|NCT02148029|144530444|SUPERIORITY||Mean Difference (Net)|0.05|STANDARD_ERROR_OF_MEAN|0.4||0.91|TWO_SIDED|95.0|-0.8|0.9|||t-test, 2 sided||Mean difference = PTS - No PTS|||0.9|-0.8|0.91
72500129|NCT02688647|144530495|SUPERIORITY|||||||0.5733|||||||Mixed Models Analysis|Results are not stable due to small sample size and signal/noise ratio||GAP Stage I-- Difference: Belumosudil-WC minus BSC-NC = 38.85 (95% CI: -126.99, 204.69) mL||||0.5733
72500130|NCT02688647|144530495|SUPERIORITY|||||||0.6967|||||||Mixed Models Analysis|Results are not stable due to small sample size and signal/noise ratio||GAP Stage II-- Difference: Belumosudil-WC minus BSC-NC = -39.96 (95% CI: -288.63, 208.71) mL||||0.6967
72500131|NCT02688647|144530495|SUPERIORITY|||||||0.5003|||||||Mixed Models Analysis|Results are not stable due to small sample size and signal/noise ratio||GAP Stage III-- Difference: Belumosudil-WC minus BSC-NC = 94.16 (95% CI: -1103.56, 1291.88) mL||||0.5003
72500132|NCT02688647|144530495|SUPERIORITY|||||||0.4866|||||||Mixed Models Analysis|Results are not stable due to small sample size and signal/noise ratio||No Prior Pirfenidone or Nintedanib-- Difference: Belumosudil-WC minus BSC-NC = -34.13 (95% CI: -137.08, 68.82)||||0.4866
72392310|NCT00378378|144292114|SUPERIORITY_OR_OTHER_LEGACY|||||||0.258||95.0|||||ANOVA|||Pairwise comparison p-values were based on a two-way ANOVA for the change from basline||||0.258
72500133|NCT02688647|144530498|SUPERIORITY|GAP Stage I-- Difference: Belumosudil-WC minus BSC-NC = 1.88 (95% CI: -2.69, 6.45)||||||0.3391|||||||Mixed Models Analysis|Results are not stable due to small sample size and signal/noise ratio||||||0.3391
72500134|NCT02688647|144530498|SUPERIORITY|GAP Stage II-- Difference: Belumosudil-WC minus BSC-NC = -1.72 (95% CI: -8.13, 4.69)||||||0.5201|||||||Mixed Models Analysis|Results are not stable due to small sample size and signal/noise ratio||||||0.5201
72500135|NCT02688647|144530498|SUPERIORITY|GAP Stage III-- Difference: Belumosudil-WC minus BSC-NC = 2.48 (95% CI: -23.84, 28.81)||||||0.4426|||||||Mixed Models Analysis|Results are not stable due to small sample size and signal/noise ratio||||||0.4426
72500136|NCT02688647|144530498|SUPERIORITY|No Prior Use of Pirfenidone or Nintedanib-- Difference: Belumosudil-WC minus BSC-NC = 8.70 (95% CI: -78.76, -96.17)||||||0.426|||||||Mixed Models Analysis|Results are not stable due to small sample size and signal/noise ratio||||||0.4260
72500137|NCT02688647|144530508|SUPERIORITY|Cox Regression||||||0.8561|TWO_SIDED|95.0|||||Log Rank|||Hazard ratio: 0.86 (0.16, 4.48)||||0.8561
72500138|NCT02688647|144530508|SUPERIORITY|Cox Regression||||||0.8608|TWO_SIDED|95.0|||||Log Rank|||Hazard ratio: 0.87 (95% CI: 0.17, 4.33)||||0.8608
72500139|NCT02688647|144530509|SUPERIORITY|Cox Regression||||||0.0084|TWO_SIDED|95.0|||||Log Rank|||Hazard ratio: 0.34 (95% CI: 0.14, 0.79)||||0.0084
72500140|NCT02688647|144530509|SUPERIORITY|Cox Regression||||||0.0508|TWO_SIDED|95.0|||||Log Rank|||Hazard Ratio: 0.47 (95% CI: 0.22, 1.03)||||0.0508
72500141|NCT02688647|144530511|SUPERIORITY|Cox Regression||||||0.4251|TWO_SIDED|95.0|||||Log Rank|||Hazard ratio: 0.34 (95% CI: 0.02, 5.54)||||0.4251
72500142|NCT02688647|144530511|SUPERIORITY|Cox Regression||||||0.3294|TWO_SIDED|95.0|||||Log Rank|||Hazard ratio: 0.27 (95% CI: 0.02, 4.45)||||0.3294
72500143|NCT02073487|144530517|SUPERIORITY||||||<|0.01|||||||Fisher Exact|||||||<0.01
72500144|NCT01262898|144530551|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-3.36|STANDARD_DEVIATION|14.47|||TWO_SIDED|95.0|-21.96|15.24|||||The least square means were estimated using a mixed model fitting treatment, visit, treatment\*visit and baseline gastric emptying half time as fixed effects, and participant as a random effect. Statistical analysis is reported using LS Means.|GSK962040 10 mg versus Placebo Day 1||15.24|-21.96|
72500145|NCT01262898|144530551|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-11.81|STANDARD_DEVIATION|14.47|||TWO_SIDED|95.0|-30.01|6.4|||||The least square means were estimated using a mixed model fitting treatment, visit, treatment\*visit and baseline gastric emptying half time as fixed effects, and participant as a random effect. Statistical analysis is reported using LS Means.|GSK962040 50 mg versus Placebo Day 1||6.40|-30.01|
72500146|NCT01262898|144530551|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-25.65|STANDARD_DEVIATION|14.47|||TWO_SIDED|95.0|-42.99|-8.32|||||The least square means were estimated using a mixed model fitting treatment, visit, treatment\*visit and baseline gastric emptying half time as fixed effects, and participant as a random effect. Statistical analysis is reported using LS Means.|GSK962040 125 mg versus Placebo Day 1||-8.32|-42.99|
72562967|NCT02578745|144657967|SUPERIORITY|||||||0.02|||||||Wilcoxon (Mann-Whitney)|||||||0.02
72455750|NCT01638000|144434664|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.032||0.99|TWO_SIDED|95.0|-0.06|0.06||If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|ANCOVA|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region as fixed factors and baseline as a covariate||Week 12 Difference vs. Mirabegron. Differences of adjusted means were calculated by subtracting the adjusted mean of mirabegron 50 mg from the adjusted mean of solifenacin 5 mg.||0.06|-0.06|0.99
72455751|NCT01638000|144434664|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|0.01|STANDARD_ERROR_OF_MEAN|0.031||0.74|TWO_SIDED|95.0|-0.05|0.07||If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|ANCOVA|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region as fixed factors and baseline as a covariate||Final visit Difference vs. Mirabegron. Differences of adjusted means were calculated by subtracting the adjusted mean of mirabegron 50 mg from the adjusted mean of solifenacin 5 mg.||0.07|-0.05|0.74
72455752|NCT01638000|144434665|SUPERIORITY_OR_OTHER_LEGACY||Rate ratio|1.03||||0.67|TWO_SIDED|95.0|0.89|1.2||If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|Poisson regression|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region and baseline as covariates.||Week 4 Rate Ratio vs. Mirabegron||1.20|0.89|0.67
72455753|NCT01638000|144434665|SUPERIORITY_OR_OTHER_LEGACY||Rate ratio|1.17||||0.073|TWO_SIDED|95.0|0.99|1.39||If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|Poisson regression|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region and baseline as covariates.||Week 8 Rate Ratio vs. Mirabegron||1.39|0.99|0.073
72455754|NCT01638000|144434665|SUPERIORITY_OR_OTHER_LEGACY||Rate ratio|1.12||||0.25|TWO_SIDED|95.0|0.92|1.37||If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|Poisson regression|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region and baseline as covariates.||Week 12 Rate Ratio vs. Mirabegron||1.37|0.92|0.25
72455755|NCT01638000|144434665|SUPERIORITY_OR_OTHER_LEGACY||Rate ratio|1.08||||0.4|TWO_SIDED|95.0|0.9|1.31||If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|Poisson regression|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region and baseline as covariates.||Final Visit Rate Ratio vs. Mirabegron||1.31|0.90|0.40
72455756|NCT01638000|144434666|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.02|STANDARD_ERROR_OF_MEAN|0.115||0.84|TWO_SIDED|95.0|-0.25|0.2||If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|ANCOVA|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region as fixed factors and baseline as a covariate||Week 4 Difference vs. Mirabegron. Differences of adjusted means were calculated by subtracting the adjusted mean of mirabegron 50 mg from the adjusted mean of solifenacin 5 mg.||0.20|-0.25|0.84
72455757|NCT01638000|144434666|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.05|STANDARD_ERROR_OF_MEAN|0.099||0.63|TWO_SIDED|95.0|-0.24|0.15||If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|ANCOVA|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region as fixed factors and baseline as a covariate||Week 8 Difference vs. Mirabegron. Differences of adjusted means were calculated by subtracting the adjusted mean of mirabegron 50 mg from the adjusted mean of solifenacin 5 mg.||0.15|-0.24|0.63
72455758|NCT01638000|144434666|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.06|STANDARD_ERROR_OF_MEAN|0.111||0.59|TWO_SIDED|95.0|-0.28|0.16||if p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|ANCOVA|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region as fixed factors and baseline as a covariate||Week 12 Difference vs. Mirabegron. Differences of adjusted means were calculated by subtracting the adjusted mean of mirabegron 50 mg from the adjusted mean of solifenacin 5 mg.||0.16|-0.28|0.59
72455759|NCT01638000|144434667|SUPERIORITY_OR_OTHER_LEGACY||Rate ratio|1.05||||0.068|TWO_SIDED|95.0|1.0|1.11||If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|Poisson regression|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region and baseline as covariates.||Week 4 Rate Ratio vs. Mirabegron||1.11|1.00|0.068
72455760|NCT01638000|144434667|SUPERIORITY_OR_OTHER_LEGACY||Rate ratio|1.04||||0.21|TWO_SIDED|95.0|0.98|1.11||If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|Poisson regression|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region and baseline as covariates.||Week 8 Rate Ratio vs. Mirabegron||1.11|0.98|0.21
72500147|NCT01262898|144530551|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|14.74|STANDARD_DEVIATION|14.47|||TWO_SIDED|95.0|-5.06|34.53|||||The least square means were estimated using a mixed model fitting treatment, visit, treatment\*visit and baseline gastric emptying half time as fixed effects, and participant as a random effect. Statistical analysis is reported using LS Means.|GSK962040 10 mg versus Placebo Day 28||34.53|-5.06|
72455761|NCT01638000|144434667|SUPERIORITY_OR_OTHER_LEGACY||Rate ratio|1.02||||0.52|TWO_SIDED|95.0|0.95|1.1||If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|Poisson regression|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region and baseline as covariates.||Week 12 Rate Ratio vs. Mirabegron||1.10|0.95|0.52
72455762|NCT01638000|144434667|SUPERIORITY_OR_OTHER_LEGACY||Rate ratio|1.03||||0.44|TWO_SIDED|95.0|0.96|1.1||If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|Poisson regression|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region and baseline as covariates.||Final Visit Rate Ratio vs. Mirabegron||1.10|0.96|0.44
72562968|NCT02578745|144657968|SUPERIORITY||||||>|0.99|TWO_SIDED|95.0|||||Chi-squared|||||||>0.99
72562969|NCT02578745|144657969|SUPERIORITY||||||>|0.99|||||||Chi-squared|||||||>0.99
72392311|NCT00378378|144292114|SUPERIORITY_OR_OTHER_LEGACY|||||||0.735||95.0|||||ANOVA|||Pairwise comparison p-values were based on a two-way ANOVA for the change from baseline.||||0.735
72455763|NCT01638000|144434668|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|0.09|STANDARD_ERROR_OF_MEAN|0.047||0.058|TWO_SIDED|95.0|0.0|0.18||If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|ANCOVA|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region as fixed factors and baseline as a covariate||Week 4 Difference vs. Mirabegron. Differences of adjusted means were calculated by subtracting the adjusted mean of mirabegron 50 mg from the adjusted mean of solifenacin 5 mg.||0.18|-0.00|0.058
72455764|NCT01638000|144434668|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|0.03|STANDARD_ERROR_OF_MEAN|0.044||0.5|TWO_SIDED|95.0|-0.06|0.12||If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|ANCOVA|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region as fixed factors and baseline as a covariate||Week 8 Difference vs. Mirabegron. Differences of adjusted means were calculated by subtracting the adjusted mean of mirabegron 50 mg from the adjusted mean of solifenacin 5 mg.||0.12|-0.06|0.50
72455765|NCT01638000|144434668|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|0.01|STANDARD_ERROR_OF_MEAN|0.046||0.81|TWO_SIDED|95.0|-0.08|0.1||If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|ANCOVA|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region as fixed factors and baseline as a covariate||Week 12 Difference vs. Mirabegron. Differences of adjusted means were calculated by subtracting the adjusted mean of mirabegron 50 mg from the adjusted mean of solifenacin 5 mg.||0.10|-0.08|0.81
72455766|NCT01638000|144434669|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.05||||0.67|TWO_SIDED|95.0|0.85|1.28||If p\<0.05, this indicates superiority in favor of the treatment group with the largest percentage of responders at specified visit.|Regression, Logistic|Treatment group, gender, age group (\<65,≥ 65), number of prior antimuscarinics (1, ≥2), geographic region and baseline value as factors.||Week 4 Odds ratio vs. Mirabegron||1.28|0.85|0.67
72455767|NCT01638000|144434669|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.25||||0.026|TWO_SIDED|95.0|1.03|1.53||If p\<0.05, this indicates superiority in favor of the treatment group with the largest percentage of responders at specified visit.|Regression, Logistic|Treatment group, gender, age group (\<65,≥ 65), number of prior antimuscarinics (1, ≥2), geographic region and baseline value as factors.||Week 8 Odds ratio vs. Mirabegron||1.53|1.03|0.026
72455768|NCT01638000|144434669|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.18||||0.11|TWO_SIDED|95.0|0.97|1.44||If p\<0.05, this indicates superiority in favor of the treatment group with the largest percentage of responders at specified visit.|Regression, Logistic|Treatment group, gender, age group (\<65,≥ 65), number of prior antimuscarinics (1, ≥2), geographic region and baseline value as factors.||Week 12 Odds ratio vs. Mirabegron||1.44|0.97|0.11
72455769|NCT01638000|144434669|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.18||||0.093|TWO_SIDED|95.0|0.97|1.43||If p\<0.05, this indicates superiority in favor of the treatment group with the largest percentage of responders at specified visit.|Regression, Logistic|Treatment group, gender, age group (\<65,≥ 65), number of prior antimuscarinics (1, ≥2), geographic region and baseline value as factors.||Final Visit Odds ratio vs. Mirabegron||1.43|0.97|0.093
72455770|NCT01638000|144434670|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.06||||0.74|TWO_SIDED|95.0|0.76|1.48||If p\<0.05, this indicates superiority in favor of the treatment group with the largest percentage of responders at specified visit.|Regression, Logistic|Treatment group, gender, age group (\<65,≥ 65), number of prior antimuscarinics (1, ≥2), geographic region and baseline value as factors.||Week 4 Odds Ratio vs. Mirabegron||1.48|0.76|0.74
72455771|NCT01638000|144434670|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.07||||0.74|TWO_SIDED|95.0|0.71|1.63||If p\<0.05, this indicates superiority in favor of the treatment group with the largest percentage of responders at specified visit.|Regression, Logistic|Treatment group, gender, age group (\<65,≥ 65), number of prior antimuscarinics (1, ≥2), geographic region and baseline value as factors.||Week 8 Odds Ratio vs. Mirabegron||1.63|0.71|0.74
72455772|NCT01638000|144434670|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.27||||0.29|TWO_SIDED|95.0|0.81|2.0||If p\<0.05, this indicates superiority in favor of the treatment group with the largest percentage of responders at specified visit.|Regression, Logistic|Treatment group, gender, age group (\<65,≥ 65), number of prior antimuscarinics (1, ≥2), geographic region and baseline value as factors.||Week 12 Odds Ratio vs. Mirabegron||2.00|0.81|0.29
72455773|NCT01638000|144434670|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.25||||0.29|TWO_SIDED|95.0|0.82|1.9||If p\<0.05, this indicates superiority in favor of the treatment group with the largest percentage of responders at specified visit.|Regression, Logistic|Treatment group, gender, age group (\<65,≥ 65), number of prior antimuscarinics (1, ≥2), geographic region and baseline value as factors.||Final visit Odds Ratio vs. Mirabegron||1.90|0.82|0.29
72455774|NCT01638000|144434671|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.22||||0.2|TWO_SIDED|95.0|0.9|1.67||If p\<0.05, this indicates superiority in favor of the treatment group with the largest percentage of responders at specified visit.|Regression, Logistic|Treatment group, gender, age group (\<65,≥ 65), number of prior antimuscarinics (1, ≥2), geographic region and baseline value as factors.||Week 4 Odds Ratio vs. Mirabegron||1.67|0.90|0.20
72455775|NCT01638000|144434671|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.91||||0.57|TWO_SIDED|95.0|0.65|1.26||If p\<0.05, this indicates superiority in favor of the treatment group with the largest percentage of responders at specified visit.|Regression, Logistic|Treatment group, gender, age group (\<65,≥ 65), number of prior antimuscarinics (1, ≥2), geographic region and baseline value as factors.||Week 8 Odds Ratio vs. Mirabegron||1.26|0.65|0.57
72455776|NCT01638000|144434671|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.98||||0.92|TWO_SIDED|95.0|0.69|1.39||If p\<0.05, this indicates superiority in favor of the treatment group with the largest percentage of responders at specified visit.|Regression, Logistic|Treatment group, gender, age group (\<65,≥ 65), number of prior antimuscarinics (1, ≥2), geographic region and baseline value as factors.||Week 12 Odds Ratio vs. Mirabegron||1.39|0.69|0.92
72455777|NCT01638000|144434671|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.02||||0.9|TWO_SIDED|95.0|0.73|1.42||If p\<0.05, this indicates superiority in favor of the treatment group with the largest percentage of responders at specified visit.|Regression, Logistic|Treatment group, gender, age group (\<65,≥ 65), number of prior antimuscarinics (1, ≥2), geographic region and baseline value as factors.||Final visit Odds Ratio vs. Mirabegron||1.42|0.73|0.90
72562970|NCT02578745|144657970|SUPERIORITY|||||||0.5|||||||Chi-squared|||||||0.50
72455778|NCT01638000|144434692|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-1.69|STANDARD_ERROR_OF_MEAN|0.817||0.039|TWO_SIDED|95.0|-3.29|-0.08||If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|ANCOVA|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region as fixed factors and baseline as covariate.||Week 4 Difference vs. Mirabegron. Difference of the adjusted mean is calculated by subtracting the adjusted mean of mirabegron from the adjusted mean of solifenacin.||-0.08|-3.29|0.039
72455779|NCT01638000|144434692|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-1.8|STANDARD_ERROR_OF_MEAN|0.849||0.034|TWO_SIDED|95.0|-3.46|-0.13||If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|ANCOVA|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region as fixed factors and baseline as covariate.||Week 8 Difference vs. Mirabegron. Difference of the adjusted mean is calculated by subtracting the adjusted mean of mirabegron from the adjusted mean of solifenacin.||-0.13|-3.46|0.034
72455780|NCT01638000|144434692|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-2.1|STANDARD_ERROR_OF_MEAN|0.917||0.022|TWO_SIDED|95.0|-3.9|-0.3||If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|ANCOVA|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region as fixed factors and baseline as covariate.||Week 12 Difference vs. Mirabegron. Difference of the adjusted mean is calculated by subtracting the adjusted mean of mirabegron from the adjusted mean of solifenacin.||-0.30|-3.90|0.022
72500148|NCT01262898|144530551|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|4.22|STANDARD_DEVIATION|14.47|||TWO_SIDED|95.0|-14.64|23.08|||||The least square means were estimated using a mixed model fitting treatment, visit, treatment\*visit and baseline gastric emptying half time as fixed effects, and participant as a random effect. Statistical analysis is reported using LS Means.|GSK962040 50 mg vs Placebo Day 28||23.08|-14.64|
72562971|NCT00330460|144657973|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin = -1.22%.|Mean Difference (Final Values)|1.0|||<|0.0001||95.0|0.7|1.2|||ANCOVA|||||1.2|0.7|<0.0001
72562972|NCT00330460|144657974|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin = -2.29%.|Mean Difference (Final Values)|1.1|||<|0.0001||95.0|0.7|1.4||The reported p-value was the one-sided adjusted p-valued based on multiplicity adjustment of the secondary efficacy endpoints|ANCOVA|||||1.4|0.7|<0.0001
72562973|NCT00330460|144657975|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin = -1.65%|Mean Difference (Final Values)|1.0|||<|0.0001||95.0|0.6|1.4||The reported p-value was the one-sided adjusted p-valued based on multiplicity adjustment of the secondary efficacy endpoints|ANCOVA|||||1.4|0.6|<0.0001
72562974|NCT00330460|144657976|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin = -1.04%|Mean Difference (Final Values)|0.6|||<|0.0001||95.0|0.3|1.0||The reported p-value was the one-sided adjusted p-valued based on multiplicity adjustment of the secondary efficacy endpoints|ANCOVA|||||1|0.3|<0.0001
72562975|NCT00330460|144657977|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.6||||0.0001||95.0|0.3|0.9||The reported p-value was the one-sided adjusted p-valued based on multiplicity adjustment of the secondary efficacy endpoints|ANCOVA|||||0.9|0.3|0.0001
72562976|NCT02663882|144657978|SUPERIORITY|||||||0.503||||||the a priori threshold for statistical significance was p\<0.05|ANOVA|||The non-smoking-related self control task was the comparison group in relation to the smoking-related self control task||||0.503
72562977|NCT02663882|144657979|SUPERIORITY|||||||0.765||||||the a priori threshold for statistical significance was p\<0.05|ANOVA|||The non-smoking-related self control task was the comparison group in relation to the smoking-related self control task||||0.765
72620679|NCT01423084|144772411|NON_INFERIORITY_OR_EQUIVALENCE|Two different lots of rMenB+OMV NZ are to be considered equivalent in terms of hSBA GMTs against H44/76 strain if the two sided 95% Confidence Interval (CI) between groups GMTs ratio at day 31 (ie, one month after the second vaccination) does not exceed the range 0.5 (lower limit) - 2.0 (higher limit).|between groups ratio|1.0|||||TWO_SIDED|95.0|0.82|1.23||||||Equivalence of 2 different lots of rMenB+OMV NZ in terms of hSBA GMTs against H44/76 strain||1.23|0.82|
72562978|NCT02663882|144657980|SUPERIORITY|||||||0.717||||||the a priori threshold for statistical significance was p=0.05|ANOVA|||The non-smoking-related self control task was the comparison group in relation to the smoking-related self control task||||0.717
72562979|NCT02663882|144657981|SUPERIORITY|||||||0.302||||||the a priori threshold for statistical significance was p=0.05|ANOVA|||The non-smoking-related self control task was the comparison group in relation to the smoking-related self control task||||0.302
72562980|NCT05070390|144657985|OTHER|GMR: Panel A-Moderate RI/Panel B-Healthy controls|Geometric Mean Ratio (GMR)|1.23|||||TWO_SIDED|90.0|0.62|2.44|||||GMR and 90% confidence interval (CI) were estimated using a linear mixed effects model and referencing a t-distribution.|||2.44|0.62|
72562981|NCT05070390|144657986|OTHER|GMR: Panel A-Moderate RI/Panel B-Healthy controls|GMR|1.63|||||TWO_SIDED|90.0|0.55|4.83|||||GMR and 90% CI were estimated using a linear mixed effects model and referencing a t-distribution.|||4.83|0.55|
72562982|NCT05070390|144657987|OTHER|GMR: Panel A-Moderate RI/Panel B-Healthy controls|GMR|1.45|||||TWO_SIDED|90.0|0.7|2.99|||||GMR and 90% CI were estimated using a linear mixed effects model and referencing a t-distribution.|||2.99|0.70|
72562983|NCT05070390|144657990|OTHER|GMR: Panel A-Moderate RI/Panel B-Healthy controls|GMR|0.82|||||TWO_SIDED|90.0|0.41|1.62|||||GMR and 90% CI were estimated using a linear mixed effects model and referencing a t-distribution.|||1.62|0.41|
72562984|NCT05070390|144657991|OTHER|GMR: Panel A-Moderate RI/Panel B-Healthy controls|GMR|0.92|||||TWO_SIDED|90.0|0.6|1.42|||||GMR and 90% CI were estimated using a linear mixed effects model and referencing a t-distribution.|||1.42|0.60|
72562985|NCT05070390|144657994|OTHER|GMR: Panel A-Moderate RI/Panel B-Healthy controls|GMR|0.82|||||TWO_SIDED|90.0|0.22|3.1|||||GMR and 90% CI were estimated using a linear mixed effects model and referencing a t-distribution.|||3.10|0.22|
72620680|NCT01423084|144772411|NON_INFERIORITY_OR_EQUIVALENCE|Two different lots of rMenB+OMV NZ are to be considered equivalent in terms of hSBA GMTs against 5/99 strain if the two sided 95% Confidence Interval (CI) between groups GMTs ratio at day 31 (ie, one month after the second vaccination ) does not exceed the range 0.5 (lower limit) - 2.0 (higher limit).|between groups ratio|0.92|||||TWO_SIDED|95.0|0.77|1.1||||||Equivalence of 2 different lots of rMenB+OMV NZ in terms of hSBA GMTs against 5/99 strain||1.1|0.77|
72622492|NCT02544763|144774966|SUPERIORITY||Percentage reduction|0.524|||||TWO_SIDED|95.0|0.452|0.607||||||||0.607|0.452|
72622493|NCT02544763|144774966|SUPERIORITY||Percentage reduction|0.731|||||TWO_SIDED|95.0|0.632|0.846||||||||0.846|0.632|
72455781|NCT01638000|144434692|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-1.87|STANDARD_ERROR_OF_MEAN|0.924||0.043|TWO_SIDED|95.0|-3.68|-0.06||If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|ANCOVA|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region as fixed factors and baseline as covariate.||Final Visit Difference vs. Mirabegron. Difference of the adjusted mean is calculated by subtracting the adjusted mean of mirabegron from the adjusted mean of solifenacin.||-0.06|-3.68|0.043
72455782|NCT01638000|144434693|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|1.14|STANDARD_ERROR_OF_MEAN|0.77||0.14|TWO_SIDED|95.0|-0.37|2.65||If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|ANCOVA|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region as fixed factors and baseline as covariate.||Week 4 Difference vs. Mirabegron. Difference of the adjusted mean is calculated by subtracting the adjusted mean of mirabegron from the adjusted mean of solifenacin.||2.65|-0.37|0.14
72455783|NCT01638000|144434693|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|1.55|STANDARD_ERROR_OF_MEAN|0.805||0.055|TWO_SIDED|95.0|-0.03|3.13||If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|ANCOVA|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region as fixed factors and baseline as covariates.||Week 8 Difference vs. Mirabegron. Difference of the adjusted mean is calculated by subtracting the adjusted mean of mirabegron from the adjusted mean of solifenacin.||3.13|-0.03|0.055
72392312|NCT00378378|144292114|SUPERIORITY_OR_OTHER_LEGACY|||||||0.194||95.0|||||ANOVA|||Pairwise comparison p-values were based on a two-way ANOVA for the change from baseline.||||0.194
72392313|NCT00378378|144292115|SUPERIORITY_OR_OTHER_LEGACY|||||||0.361||95.0|||||ANOVA|||Pairwise comparison p-values were based on a two-way ANOVA for baseline to endpoint||||0.361
72455784|NCT01638000|144434693|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|1.55|STANDARD_ERROR_OF_MEAN|0.866||0.074|TWO_SIDED|95.0|-0.15|3.25||If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|ANCOVA|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region as fixed factors and baseline as covariates.||Week 12 Difference vs. Mirabegron. Difference of the adjusted mean is calculated by subtracting the adjusted mean of mirabegron from the adjusted mean of solifenacin.||3.25|-0.15|0.074
72455785|NCT01638000|144434693|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|1.41|STANDARD_ERROR_OF_MEAN|0.873||0.11|TWO_SIDED|95.0|-0.3|3.12||If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|ANCOVA|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region as fixed factors and baseline as covariates.||Final Visit Difference vs. Mirabegron. Difference of the adjusted mean is calculated by subtracting the adjusted mean of mirabegron from the adjusted mean of solifenacin.||3.12|-0.30|0.11
72455786|NCT01638000|144434694|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.09|STANDARD_ERROR_OF_MEAN|0.05||0.07|TWO_SIDED|95.0|-0.19|0.01||If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|ANCOVA|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region as fixed factors and baseline as covariate.||Week 4 Difference vs. Mirabegron. Difference of the adjusted mean is calculated by subtracting the adjusted mean of mirabegron from the adjusted mean of solifenacin.||0.01|-0.19|0.070
72455787|NCT01638000|144434694|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.16|STANDARD_ERROR_OF_MEAN|0.054||0.003|TWO_SIDED|95.0|-0.27|-0.06||If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|ANCOVA|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region as fixed factors and baseline as covariate.||Week 8 Difference vs. Mirabegron. Difference of the adjusted mean is calculated by subtracting the adjusted mean of mirabegron from the adjusted mean of solifenacin.||-0.06|-0.27|0.003
72455788|NCT01638000|144434694|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.15|STANDARD_ERROR_OF_MEAN|0.06||0.015|TWO_SIDED|95.0|-0.26|-0.03||If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|ANCOVA|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region as fixed factors and baseline as covariate.||Week 12 Difference vs. Mirabegron.Difference of the adjusted mean is calculated by subtracting the adjusted mean of mirabegron from the adjusted mean of solifenacin.||-0.03|-0.26|0.015
72455789|NCT01638000|144434694|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.14|STANDARD_ERROR_OF_MEAN|0.059||0.021|TWO_SIDED|95.0|-0.25|-0.02||If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|ANCOVA|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region as fixed factors and baseline as covariate.||Final Visit Difference vs. Mirabegron. Difference of the adjusted mean is calculated by subtracting the adjusted mean of mirabegron from the adjusted mean of solifenacin.||-0.02|-0.25|0.021
72455790|NCT01638000|144434695|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|0.43|STANDARD_ERROR_OF_MEAN|0.141||0.002|TWO_SIDED|95.0|0.15|0.7||If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|ANCOVA|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region as fixed factors and baseline as covariate.||Week 12 Difference vs. Mirabegron. Difference of the adjusted mean is calculated by subtracting the adjusted mean of mirabegron from the adjusted mean of solifenacin.||0.70|0.15|0.002
72500149|NCT01262898|144530551|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|6.65|STANDARD_DEVIATION|14.47|||TWO_SIDED|95.0|-11.18|24.47|||||The least square means were estimated using a mixed model fitting treatment, visit, treatment\*visit and baseline gastric emptying half time as fixed effects, and participant as a random effect. Statistical analysis is reported using LS Means.|GSK962040 125 mg versus Placebo Day 28||24.47|-11.18|
72392314|NCT00378378|144292115|SUPERIORITY_OR_OTHER_LEGACY|||||||0.603||95.0|||||ANOVA|||Pairwise comparison p-values were based on a two-way ANOVA for baseline to endpoint.||||0.603
72392315|NCT00378378|144292115|SUPERIORITY_OR_OTHER_LEGACY|||||||0.193||95.0|||||ANOVA|||Pairwise comparison p-values were based on a two-way ANOVA for baseline to endpoint.||||0.193
72455791|NCT01638000|144434695|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|0.42|STANDARD_ERROR_OF_MEAN|0.141||0.003|TWO_SIDED|95.0|0.14|0.7||If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|ANCOVA|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region as fixed factors and baseline as covariate.||Final Visit Difference vs. Mirabegron. Difference of the adjusted mean is calculated by subtracting the adjusted mean of mirabegron from the adjusted mean of solifenacin.||0.70|0.14|0.003
72455792|NCT01638000|144434696|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean diffrence|0.16|STANDARD_ERROR_OF_MEAN|0.07||0.027|TWO_SIDED|95.0|0.02|0.29||If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|ANCOVA|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region as fixed factors and baseline as covariate.||Week 12 Difference vs. Mirabegron. Difference of the adjusted mean is calculated by subtracting the adjusted mean of mirabegron from the adjusted mean of solifenacin.||0.29|0.02|0.027
72455793|NCT01638000|144434696|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|0.15|STANDARD_ERROR_OF_MEAN|0.071||0.034|TWO_SIDED|95.0|0.01|0.29||If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|ANCOVA|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region as fixed factors and baseline as covariate.||Final Visit Difference vs. Mirabegron. Difference of the adjusted mean is calculated by subtracting the adjusted mean of mirabegron from the adjusted mean of solifenacin.||0.29|0.01|0.034
72455794|NCT01638000|144434697|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.4||||0.01|TWO_SIDED|95.0|1.08|1.81||If p\<0.05, this indicates superiority in favor of the treatment group with the largest percentage of responders at specified visit.|Regression, Logistic|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region and baseline value as factors.||Week 12 Odds Ratio vs. Mirabegron||1.81|1.08|0.010
72455795|NCT01638000|144434697|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.37||||0.011|TWO_SIDED|95.0|1.07|1.75||If p\<0.05, this indicates superiority in favor of the treatment group with the largest percentage of responders at specified visit.|Regression, Logistic|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region and baseline value as factors.||Final visit Odds Ratio vs. Mirabegron||1.75|1.07|0.011
72455796|NCT01638000|144434698|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.28||||0.037|TWO_SIDED|95.0|1.02|1.62||If p\<0.05, this indicates superiority in favor of the treatment group with the largest percentage of responders at specified visit.|Regression, Logistic|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region and baseline value as factors.||Week 12 Odds Ratio vs. Mirabegron||1.62|1.02|0.037
72455797|NCT01638000|144434698|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.26||||0.045|TWO_SIDED|95.0|1.01|1.57||If p\<0.05, this indicates superiority in favor of the treatment group with the largest percentage of responders at specified visit.|Regression, Logistic|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region and baseline value as factors.||Final visit Odds Ratio vs. Mirabegron||1.57|1.01|0.045
72455798|NCT01638000|144434699|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.51||||0.009|TWO_SIDED|95.0|1.11|2.06||Iif p\<0.05, this indicates superiority in favor of the treatment group with the largest percentage of responders at specified visit.|Regression, Logistic|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region and baseline value as factors.||Week 12 (≥1 point improvement) Odds Rato vs. Mirabegron||2.06|1.11|0.009
72455799|NCT01638000|144434699|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.27||||0.065|TWO_SIDED|95.0|0.99|1.65||If p\<0.05, this indicates superiority in favor of the treatment group with the largest percentage of responders at specified visit.|Regression, Logistic|Treatment group, gender, age group (\<65,≥ 65), number of prior antimuscarinics (1, ≥2), geographic region and baseline value as factors.||Week 12 (≥2 point improvement) Odds Rato vs. Mirabegron||1.65|0.99|0.065
72455800|NCT01638000|144434699|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.25||||0.051|TWO_SIDED|95.0|1.0|1.55||If p\<0.05, this indicates superiority in favor of the treatment group with the largest percentage of responders at specified visit.|Regression, Logistic|treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region and baseline value as factors.||Week 12 (≥3 point improvement) Odds Rato vs. Mirabegron||1.55|1.00|0.051
72455801|NCT01638000|144434699|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.18||||0.14|TWO_SIDED|95.0|0.95|1.47||If p\<0.05, this indicates superiority in favor of the treatment group with the largest percentage of responders at specified visit.|Regression, Logistic|treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region and baseline value as factors.||Week 12 (≥4 point improvement) Odds Rato vs. Mirabegron||1.47|0.95|0.14
72455802|NCT01638000|144434699|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.02||||0.89|TWO_SIDED|95.0|0.75|1.4||If p\<0.05, this indicates superiority in favor of the treatment group with the largest percentage of responders at specified visit.|Regression, Logistic|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region and baseline value as factors.||Week 12 (≥5 point improvement) Odds Rato vs. Mirabegron||1.40|0.75|0.89
72455803|NCT01638000|144434699|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.14||||0.66|TWO_SIDED|95.0|0.64|2.04||If p\<0.05, this indicates superiority in favor of the treatment group with the largest percentage of responders at specified visit.|Regression, Logistic|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region and baseline value as factors.|Participants from Canada were therefore excluded from this analysis due to low participant numbers.|Week 12 (6 point improvement) Odds Rato vs. Mirabegron||2.04|0.64|0.66
72562986|NCT05070390|144657995|OTHER|GMR: Panel A-Moderate RI/Panel B-Healthy controls|GMR|0.82|||||TWO_SIDED|90.0|0.22|3.1|||||GMR and 90% CI were estimated using a linear mixed effects model and referencing a t-distribution.|||3.10|0.22|
72562987|NCT05070390|144657996|OTHER|GMR: Panel A-Moderate RI/Panel B-Healthy controls|GMR|0.38|||||TWO_SIDED|90.0|0.13|1.13|||||GMR and 90% CI were estimated using a linear mixed effects model and referencing a t-distribution.|||1.13|0.13|
72562988|NCT00479388|144658017|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-4.5|STANDARD_ERROR_OF_MEAN|1.6||0.006||95.0|-7.7|-1.3|||Repeated measures analysis|Study times: 4, 8 and 12 weeks. Terms: treatment-by-time, gender-by-time, baseline LDL-C-by-time and concomitant statin group-by-time interaction.||||-1.3|-7.7|0.006
72455804|NCT01638000|144434700|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.44||||0.016|TWO_SIDED|95.0|1.07|1.93||If p\<0.05, this indicates superiority in favor of the treatment group with the largest percentage of responders at specified visit.|Regression, Logistic|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region and baseline value as factors.||Final visit (≥1 point improvement) Odds Rato vs. Mirabegron||1.93|1.07|0.016
72455805|NCT01638000|144434700|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.27||||0.063|TWO_SIDED|95.0|0.99|1.62||If p\<0.05, this indicates superiority in favor of the treatment group with the largest percentage of responders at specified visit.|Regression, Logistic|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region and baseline value as factors.||Final visit (≥2 point improvement) Odds Rato vs. Mirabegron||1.62|0.99|0.063
72455806|NCT01638000|144434700|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.24||||0.054|TWO_SIDED|95.0|1.0|1.53||If p\<0.05, this indicates superiority in favor of the treatment group with the largest percentage of responders at specified visit.|Regression, Logistic|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region and baseline value as factors.||Final visit (≥3 point improvement) Odds Rato vs. Mirabegron||1.53|1.00|0.054
72455807|NCT01638000|144434700|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.17||||0.15|TWO_SIDED|95.0|0.95|1.46||If p\<0.05, this indicates superiority in favor of the treatment group with the largest percentage of responders at specified visit.|Regression, Logistic|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region and baseline value as factors.||Final visit (≥4 point improvement) Odds Rato vs. Mirabegron||1.46|0.95|0.15
72455808|NCT01638000|144434700|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.05||||0.75|TWO_SIDED|95.0|0.77|1.44||If p\<0.05, this indicates superiority in favor of the treatment group with the largest percentage of responders at specified visit.|Regression, Logistic|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region and baseline value as factors.||Final visit (≥5 point improvement) Odds Rato vs. Mirabegron||1.44|0.77|0.75
72455809|NCT01638000|144434700|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.14||||0.66|TWO_SIDED|95.0|0.64|2.04||If p\<0.05, this indicates superiority in favor of the treatment group with the largest percentage of responders at specified visit.|Regression, Logistic|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region and baseline value as factors.|Participants from Canada were therefore excluded from this analysis due to low participant numbers.|Final visit (6 point improvement) Odds Rato vs. Mirabegron||2.04|0.64|0.66
72455810|NCT01638000|144434701|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.24||||0.082|TWO_SIDED|95.0|0.97|1.57||If p\<0.05, this indicates superiority in favor of the treatment group with the largest percentage of responders at specified visit.|Regression, Logistic|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region and baseline value as factors.||Week 12 Odds Ratio vs. Mirabegron||1.57|0.97|0.082
72455811|NCT01638000|144434701|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.18||||0.15|TWO_SIDED|95.0|0.94|1.49||If p\<0.05, this indicates superiority in favor of the treatment group with the largest percentage of responders at specified visit.|Regression, Logistic|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region and baseline value as factors.||Final visit Odds Ratio vs. Mirabegron||1.49|0.94|0.15
72455812|NCT01638000|144434702|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.23||||0.058|TWO_SIDED|95.0|0.99|1.53||If p\<0.05, this indicates superiority in favor of the treatment group with the largest percentage of responders at specified visit.|Regression, Logistic|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region and baseline value as factors.||Week 12 Odds Ratio vs. Mirabegron||1.53|0.99|0.058
72455813|NCT01638000|144434702|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.21||||0.069|TWO_SIDED|95.0|0.99|1.5||If p\<0.05, this indicates superiority in favor of the treatment group with the largest percentage of responders at specified visitI|Regression, Logistic|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region and baseline value as factors.||Final visit Odds Ratio vs. Mirabegron||1.50|0.99|0.069
72455814|NCT04218864|144434725|SUPERIORITY||||||>|0.05||||||Threshold for statistical significance = 0.05|Regression, Linear|Results presented are unadjusted for any covariates.||Linear Mixed regression models (LMM) have been used to identify any difference between the intervention and the control groups over time with regards to the continuous outcomes. Group (intervention vs. control), a 5-category time (baseline, 6 week, 3 month, 6 month, 12 month) and group-by-time interaction are covariates in the model. A random subject intercept is used to account for clustering within subject.||||>0.05
72455815|NCT04218864|144434726|SUPERIORITY||||||>|0.05||||||Threshold for statistical significance = 0.05|Regression, Linear|Results presented are unadjusted for any covariates.||Statistical analysis strategy is identical to that for the primary outcome.||||>0.05
72455816|NCT04218864|144434727|SUPERIORITY||||||>|0.05||||||Threshold for statistical significance = 0.05|Regression, Linear|Results presented are unadjusted for any covariates.||Statistical analysis strategy is identical to that for the primary outcome.||||>0.05
72455817|NCT04218864|144434728|SUPERIORITY||||||>|0.05||||||Threshold for statistical significance = 0.05|Regression, Linear|Results presented are unadjusted for any covariates.||Statistical analysis strategy is identical to that for primary outcome.||||>0.05
72455818|NCT04218864|144434729|SUPERIORITY||||||>|0.05||||||Threshold for statistical significance = 0.05|Regression, Linear|Results presented are unadjusted for any covariates.||Statistical Analysis strategy is identical to that for primary outcome measure.||||>0.05
72562989|NCT00479388|144658018|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|15.6|STANDARD_ERROR_OF_MEAN|1.2|<=|0.001||95.0|13.4|17.9|||Repeated measures analysis|Study times: 4, 8 and 12 weeks. Terms: treatment-by-time, gender-by-time, baseline HDL-C-by-time and concomitant statin group-by-time interaction.||||17.9|13.4|<=0.001
72562990|NCT00479388|144658019|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.4|||<=|0.001||95.0|-19.2|-11.7|||Repeated measures analysis|ANCOVA model based on Tukey's normalized ranks with term for treatment, gender, concomitant statin group and Tukey's normal score of baseline.||||-11.7|-19.2|<=0.001
72455819|NCT02660086|144434758|SUPERIORITY||Mean Difference (Net)|0.2||||0.7|TWO_SIDED|95.0|-0.6|1.0|||Mixed Models Analysis|||||1.0|-0.6|0.70
72455820|NCT02660086|144434759|SUPERIORITY||Mean Difference (Net)|0.6||||0.2|TWO_SIDED|95.0|-0.3|1.4|||Mixed Models Analysis|||||1.4|-0.3|0.20
72455821|NCT02660086|144434760|SUPERIORITY||Mean Difference (Net)|-1.3||||0.24|TWO_SIDED|95.0|-3.6|0.9|||Mixed Models Analysis|||Change in systolic BP at 12 months||0.9|-3.6|0.24
72455822|NCT02660086|144434760|SUPERIORITY||Mean Difference (Net)|1.5||||0.19|TWO_SIDED|95.0|-0.7|3.7|||Mixed Models Analysis|||Change in systolic BP at 24 months||3.7|-0.7|0.19
72455823|NCT02660086|144434760|SUPERIORITY||Mean Difference (Net)|-1.6||||0.07|TWO_SIDED|95.0|-3.2|0.1|||Mixed Models Analysis|||Change in diastolic BP at 12 months||0.1|-3.2|0.07
72455824|NCT02660086|144434760|SUPERIORITY||Mean Difference (Net)|0.1||||0.94|TWO_SIDED|95.0|-1.5|1.6|||Mixed Models Analysis|||Change in diastolic BP at 24 months||1.6|-1.5|0.94
72455825|NCT02660086|144434761|SUPERIORITY||Mean Difference (Net)|-1.3||||0.54|TWO_SIDED|95.0|-5.6|2.9|||Mixed Models Analysis|||Change in total cholesterol at 12 months||2.9|-5.6|0.54
72455826|NCT02660086|144434761|SUPERIORITY||Mean Difference (Net)|1.6||||0.53|TWO_SIDED|95.0|-3.5|6.7|||Mixed Models Analysis|||Change in total cholesterol at 24 months||6.7|-3.5|0.53
72455827|NCT02660086|144434762|SUPERIORITY||Mean Difference (Net)|-1.2||||0.51|TWO_SIDED|95.0|-4.8|2.4|||Mixed Models Analysis|||Change in LDL at 12 months||2.4|-4.8|0.51
72455828|NCT02660086|144434762|SUPERIORITY||Mean Difference (Net)|1.2||||0.6|TWO_SIDED|95.0|-3.4|5.7|||Mixed Models Analysis|||Change in LDL at 24 months||5.7|-3.4|0.60
72455829|NCT02660086|144434763|SUPERIORITY||Mean Difference (Net)|-2.9||||0.48|TWO_SIDED|95.0|-10.8|5.1|||Mixed Models Analysis|||Change in triglycerides at 12 months||5.1|-10.8|0.48
72455830|NCT02660086|144434763|SUPERIORITY||Mean Difference (Net)|4.0||||0.29|TWO_SIDED|95.0|-3.4|11.5|||Mixed Models Analysis|||Change in triglycerides at 24 months||11.5|-3.4|0.29
72455831|NCT02660086|144434764|SUPERIORITY||Mean Difference (Net)|-0.2||||0.8|TWO_SIDED|95.0|-1.9|1.5|||Mixed Models Analysis|||Change in HDL at 12 months||1.5|-1.9|0.80
72455832|NCT02660086|144434764|SUPERIORITY||Mean Difference (Net)|-0.3||||0.72|TWO_SIDED|95.0|-1.9|1.3|||Mixed Models Analysis|||Change in HDL at 24 months||1.3|-1.9|0.72
72455833|NCT02660086|144434765|SUPERIORITY||Mean Difference (Net)|0.0||||0.62|TWO_SIDED|95.0|-0.1|0.1|||Mixed Models Analysis|||Change in hemoglobin A1C at 12 months||0.1|-0.1|0.62
72455834|NCT02660086|144434765|SUPERIORITY||Mean Difference (Net)|0.0||||0.4|TWO_SIDED|95.0|0.0|0.1|||Mixed Models Analysis|||Change in hemoglobin A1C at 24 months||0.1|0.0|0.40
72455835|NCT02660086|144434766|SUPERIORITY||Mean Difference (Net)|7.3|||<|0.001|TWO_SIDED|95.0|5.4|9.3|||Mixed Models Analysis|||Change in green labeled purchases during 12 month intervention (months 1-12) compared to baseline 12 months||9.3|5.4|<0.001
72455836|NCT02660086|144434766|SUPERIORITY||Mean Difference (Net)|4.8|||<|0.001|TWO_SIDED|95.0|2.9|6.8|||Mixed Models Analysis|||Change in green-labeled purhases during 12 month follow-up (months 13-24) compared to 12 month baseline||6.8|2.9|<0.001
72455837|NCT02660086|144434767|SUPERIORITY||Mean Difference (Net)|-3.9|||<|0.001|TWO_SIDED|95.0|-5.0|-2.7|||Mixed Models Analysis|||Change in red labeled purchases during 12 month intervention (months 1-12) compared to baseline 12 months||-2.7|-5.0|<0.001
72455838|NCT02660086|144434767|SUPERIORITY||Mean Difference (Net)|-3.1|||<|0.001|TWO_SIDED|95.0|-4.3|-2.0|||Mixed Models Analysis|||Change in red labeled purchases during 12-month follow up (months 13-24) compared to baseline 12 months||-2.0|-4.3|<0.001
72455839|NCT02660086|144434768|SUPERIORITY||Mean Difference (Net)|5.6|||<|0.001|TWO_SIDED|95.0|4.2|7.0|||Mixed Models Analysis|||Change in healthy purchasing score during 12 month intervention (months 1-12) compared to baseline 12 months||7.0|4.2|<0.001
72455840|NCT02660086|144434768|SUPERIORITY||Mean Difference (Net)|4.0|||<|0.001|TWO_SIDED|95.0|2.6|5.3|||Mixed Models Analysis|||Change in Healthy Purchasing Score during 12 month follow up (months 13-24) compared to baseline 12 months||5.3|2.6|<0.001
72455841|NCT02660086|144434769|SUPERIORITY||Mean Difference (Net)|1.8|||||TWO_SIDED|95.0|-0.6|4.1||||||Change in HEI scores at 12 months.||4.1|-0.6|
72455842|NCT02660086|144434769|SUPERIORITY||Mean Difference (Net)|1.6|||||TWO_SIDED|95.0|-0.7|3.8||||||Change in HEI scores at 24 months||3.8|-0.7|
72455843|NCT01653509|144434770|SUPERIORITY_OR_OTHER||Least square mean difference|-911.48||||0.3061|TWO_SIDED|95.0|-2712.65|889.69|||ANOVA|ANOVA model with a factor for treatment group.|Difference calculated as first named treatment minus second named treatment, such that a negative difference favours the first named treatment.|Null hypothesis considered no difference between study treatments for TEV.||889.69|-2712.65|0.3061
72455844|NCT01653509|144434770|SUPERIORITY_OR_OTHER||LS Mean Difference|-150.99||||0.4035|TWO_SIDED|95.0|-517.97|215.99|||ANOVA|ANOVA model with a factor for treatment group.|Difference calculated as first named treatment minus second named treatment, such that a negative difference favours the first named treatment.|Null hypothesis considered no difference between treatments for MEV.||215.99|-517.97|0.4035
72455845|NCT01653509|144434771|SUPERIORITY_OR_OTHER||LS Mean Difference|2.48||||0.0486|TWO_SIDED|95.0|0.02|4.93|||ANOVA|ANOVA model with a factor for treatment group.|Difference calculated as first named treatment minus second named treatment, such that a negative difference favours the first named treatment.|Null hypothesis considered no difference between study treatments for TEV (Day 1 to day 10).||4.93|0.02|0.0486
72455846|NCT01653509|144434771|SUPERIORITY_OR_OTHER||LS Mean Difference|0.38||||0.0799|TWO_SIDED|95.0|-0.05|0.82|||ANOVA|ANOVA model with a factor for treatment group.|Difference calculated as first named treatment minus second named treatment, such that a negative difference favours the first named treatment.|Null hypothesis considered no difference between study treatments for MEV.||0.82|-0.05|0.0799
72455847|NCT01653509|144434772|SUPERIORITY_OR_OTHER||LS mean difference|2.14||||0.179|TWO_SIDED|95.0|-1.06|5.35|||ANOVA|ANOVA model with a factor for treatment group.|Difference calculated as first named treatment minus second named treatment, such that a negative difference favours the first named treatment.|Null hypothesis considered no difference between study treatments for TEV.||5.35|-1.06|0.1790
72455848|NCT01653509|144434772|SUPERIORITY_OR_OTHER||LS mean difference|0.37||||0.2446|TWO_SIDED|95.0|-0.27|1.0|||ANOVA|ANOVA model with a factor for treatment group.|Difference calculated as first named treatment minus second named treatment, such that a negative difference favours the first named treatment.|Null hypothesis considered no difference between study treatments for MEV.||1.00|-0.27|0.2446
72500150|NCT01262898|144530551|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-12.92|STANDARD_DEVIATION|14.47|||TWO_SIDED|95.0|-28.73|2.9|||||The least square means were estimated using a mixed model fitting treatment, visit, treatment\*visit and baseline gastric emptying half time as fixed effects, and participant as a random effect. Statistical analysis is reported using LS Means.|Day 28 versus Day 1 of the Placebo arm||2.90|-28.73|
72455849|NCT01303796|144434778|SUPERIORITY||Hazard Ratio (HR)|1.013|||<|0.0249|TWO_SIDED|95.0|0.837|1.226||one-sided|Kaplan-Meier|||The phase III part planned to randomize 485 patients, about 243 per arm (actual 241 patients per arm), over an estimated period of 24 months. Final analysis would occur at approximately 424 deaths, which was expected to be observed about 43 months after the accrual of the first patient. A stratified log rank analysis would have 90% power to detect a 27.5% reduction in the risk of death, i.e., a hazard ratio of 0.725, between Arm A and Arm C.||1.226|0.837|<0.0249
72455850|NCT01303796|144434778|SUPERIORITY||Cox Proportional Hazard|1.08|||<|0.0249|TWO_SIDED|95.0|0.86|1.35||one-sided|Log Rank||Predictive factor adjusted; when interaction term was not significant at 10% confidence level, the interaction term was removed from the model.|"Subgroup analyses (pre-specified): Presence of antecedent MDS or MPD (covariate)~Treatment covariate: alternating sapacitabine/decitabine treatment Levels: No (i.e., de novo) vs Presence of antecedent MDS or MPD"||1.35|0.86|<0.0249
72455851|NCT01303796|144434778|SUPERIORITY|Effects of treatments compared in AML patients with baseline WBC count ≥ 10 x 109/L vs WBC count ≤ 10 x 109/L|Cox Proportional Hazard|1.57|||<|0.0249|TWO_SIDED|95.0|1.12|2.19||one-sided|Log Rank||Predictive factor adjusted; when interaction term was not significant at 10% confidence level, the interaction term was removed from the model.|"Subgroup analyses (pre-specified): Baseline peripheral WBC count ≥ 10 x 109/L (covariate)~Treatment covariate: alternating sapacitabine/decitabine treatment Levels: Baseline WBC count ≥ 10 x 109/L vs WBC count ≤ 10 x 109/L"||2.19|1.12|<0.0249
72455852|NCT01303796|144434778|SUPERIORITY||Cox Proportional Hazard|1.01|||<|0.0249|TWO_SIDED|95.0|0.77|1.32||one-sided|Log Rank||Predictive factor adjusted; when interaction term was not significant at 10% confidence level, the interaction term was removed from the model.|"Subgroup analyses (pre-specified): Baseline bone marrow blast percentage ≥ 50% (covariate)~Treatment covariate: alternating sapacitabine/decitabine treatment Levels: Baseline bone marrow blast percentage ≥ 50% vs Blast percentage ≤ 50%"||1.32|0.77|<0.0249
72455853|NCT01303796|144434778|SUPERIORITY||Cox Proportional Hazard|1.27|||<|0.0249|TWO_SIDED|95.0|0.94|1.73|||Log Rank||Predictive factor adjusted; when interaction term was not significant at 10% confidence level, the interaction term was removed from the model.|"Subgroup analyses (pre-specified): Unfavorable cytogenetics risk by SWOG (covariate)~Treatment covariate: alternating sapacitabine/decitabine treatment Levels: Unfavorable cytogenetics vs other"||1.73|0.94|<0.0249
72500151|NCT01262898|144530551|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|5.18|STANDARD_DEVIATION|14.47|||TWO_SIDED|95.0|-11.69|22.05|||||The least square means were estimated using a mixed model fitting treatment, visit, treatment\*visit and baseline gastric emptying half time as fixed effects, and participant as a random effect. Statistical analysis is reported using LS Means.|Day 28 versus Day 1 of GSK962040 10 mg arm||22.05|-11.69|
72500152|NCT01262898|144530551|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|3.11|STANDARD_DEVIATION|14.47|||TWO_SIDED|95.0|-13.13|19.36|||||The least square means were estimated using a mixed model fitting treatment, visit, treatment\*visit and baseline gastric emptying half time as fixed effects, and participant as a random effect. Statistical analysis is reported using LS Means.|Day 28 versus Day 1 of GSK962040 50 mg arm||19.36|-13.13|
72500153|NCT01262898|144530551|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|19.39|STANDARD_DEVIATION|14.47|||TWO_SIDED|95.0|4.47|34.3|||||The least square means were estimated using a mixed model fitting treatment, visit, treatment\*visit and baseline gastric emptying half time as fixed effects, and participant as a random effect. Statistical analysis is reported using LS Means.|Day 28 versus Day 1 of GSK962040 125 mg arm||34.30|4.47|
72500154|NCT01262898|144530551|SUPERIORITY_OR_OTHER_LEGACY||Slope|-0.225|||||TWO_SIDED|95.0|-0.32|-0.129|||Mixed Models Analysis|||Type 1 Diabetes, Day 1|Intercept estimate was 125.45 and between participant standard deviation was 21.63|-0.129|-0.320|
72455854|NCT01303796|144434778|SUPERIORITY||Cox Proportional Hazard|1.222|||<|0.0249|TWO_SIDED|||||one-sided|Log Rank||Predictive factor adjusted; when interaction term was not significant at 10% confidence level, the interaction term was removed from the model.|"Subgroup analyses (post-hoc): Region (covariate)~Treatment covariate: alternating sapacitabine/decitabine treatment (Arm A) Levels: EU vs US"||||<0.0249
72455855|NCT01303796|144434778|SUPERIORITY||Cox Proportional Hazard|1.071|||<|0.0249|TWO_SIDED|||||one-sided|Log Rank||Predictive factor adjusted; when interaction term was not significant at 10% confidence level, the interaction term was removed from the model.|"Subgroup analyses (post-hoc): Age (covariate)~Treatment covariate: alternating sapacitabine/decitabine treatment (Arm A) Levels: ≥ 75 years old vs ≤ 75 years old"||||<0.0249
72455856|NCT01303796|144434778|SUPERIORITY||Cox Proportional Hazard|0.956|||<|0.0249|TWO_SIDED|||||one-sided|Log Rank||Predictive factor adjusted; when interaction term was not significant at 10% confidence level, the interaction term was removed from the model.|"Subgroup analyses (post-hoc): Gender (covariate)~Treatment covariate: alternating sapacitabine/decitabine treatment (Arm A) Levels: Male vs Female"||||<0.0249
72455857|NCT01303796|144434778|SUPERIORITY||||||<|0.0249||||||one-sided|Log Rank|Predictive factor adjusted; when interaction term was not significant at 10% confidence level, the interaction term was removed from the model.||"Subgroup analyses (post-hoc): ECOG status (covariate)~Treatment covariate: alternating sapacitabine/decitabine treatment (Arm A) Levels: Status 2 vs \< 2"||||<0.0249
72455858|NCT01303796|144434778|SUPERIORITY||||||<|0.0249||||||one-sided|Log Rank|Predictive factor adjusted; when interaction term was not significant at 10% confidence level, the interaction term was removed from the model.||"Subgroup analyses (post-hoc): HCT-CI score (covariate)~Treatment covariate: alternating sapacitabine/decitabine treatment Levels: HCT-CI score 0-2 vs HCT-CI score \>2"||||<0.0249
72455859|NCT01303796|144434779|SUPERIORITY||Cox Proportional Hazard|1.34||||0.1468|TWO_SIDED|95.0|0.645|2.782|||Fisher Exact|||||2.782|0.645|0.1468
72455860|NCT01303796|144434784|SUPERIORITY|||||||0.0416|||||||Wilcoxon (Mann-Whitney)|||||||0.0416
72562991|NCT01955044|144658027|SUPERIORITY||Median Difference (Final Values)|1.23||||0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||DHA levels||||0.05
72455861|NCT01303796|144434785|SUPERIORITY|||||||0.1568|||||||Wilcoxon (Mann-Whitney)|||||||0.1568
72500155|NCT01262898|144530551|SUPERIORITY_OR_OTHER_LEGACY||Slope|-0.078|||||TWO_SIDED|95.0|-0.171|0.016|||Mixed Models Analysis|||Type 1 Diabetes, Day 28|Intercept estimate was 125.45 and between participant standard deviation was 21.63|0.016|-0.171|
72500156|NCT01262898|144530551|SUPERIORITY_OR_OTHER_LEGACY||Slope|-0.225|||||TWO_SIDED|95.0|-0.32|-0.129|||Mixed Models Analysis|||Type 2 Diabetes, Day 1|Intercept estimate was 113.23 and between participant standard deviation was 21.63|-0.129|-0.320|
72455862|NCT01303796|144434786|SUPERIORITY||Cox Proportional Hazard|1.013|||<|0.0249|TWO_SIDED|95.0|0.837|1.226||one-sided|Log Rank|||||1.226|0.837|<0.0249
72455863|NCT01711294|144434792|SUPERIORITY|Sample sizes were calculated using two-sample t-test for the primary endpoint and z-test for the secondary endpoint with power of 80% and two-sided alpha of 0.05. Hochberg step up procedure was used to adjust for multiple comparison. A p-value \< 0.05 was considered statistically significant.||||||0.84||||||Hochberg step up procedure was used to adjust for multiple comparison.|Wilcoxon (Mann-Whitney)|Wilcoxon was used instead of t-test because the data was not normally distributed.||Study hypothesizes that aspiration % in the 19G Flex and 19G arms would be superior by at least 10% to 22G arm, and aspiration success rate of 19G Flex would be at least 16% greater than 22G and 19G arms. Sample size calculation was performed based on the above hypotheses reached by a consensus of all collaborators and adjusted a priori.||||0.84
72455864|NCT02605174|144434808|SUPERIORITY||Odds Ratio (OR)|1.5||||0.003|TWO_SIDED|95.0|1.1|1.9|||Regression, Logistic|||||1.9|1.1|0.003
72455865|NCT02605174|144434808|SUPERIORITY||Odds Ratio (OR)|1.7|||<|0.001|TWO_SIDED|95.0|1.3|2.2|||Regression, Logistic|||||2.2|1.3|<0.001
72455866|NCT02605174|144434808|SUPERIORITY||Odds Ratio (OR)|2.3|||<|0.001|TWO_SIDED|95.0|1.8|3.1|||Regression, Logistic|||||3.1|1.8|<0.001
72455867|NCT02605174|144434809|SUPERIORITY||Odds Ratio (OR)|1.4||||0.009|TWO_SIDED|95.0|1.1|1.8|||Regression, Logistic|||||1.8|1.1|0.009
72455868|NCT02605174|144434809|SUPERIORITY||Odds Ratio (OR)|1.6|||<|0.001|TWO_SIDED|95.0|1.2|2.0|||Regression, Logistic|||||2.0|1.2|<0.001
72455869|NCT02605174|144434809|SUPERIORITY||Odds Ratio (OR)|1.9|||<|0.001|TWO_SIDED|95.0|1.4|2.4|||Regression, Logistic|||||2.4|1.4|<0.001
72455870|NCT02605174|144434810|SUPERIORITY||Odds Ratio (OR)|1.7|||<|0.001|TWO_SIDED|95.0|1.3|2.2|||Regression, Logistic|||||2.2|1.3|<0.001
72455871|NCT02605174|144434810|SUPERIORITY||Odds Ratio (OR)|2.3|||<|0.001|TWO_SIDED|95.0|1.7|2.9|||Regression, Logistic|||||2.9|1.7|<0.001
72455872|NCT02605174|144434810|SUPERIORITY||Odds Ratio (OR)|2.4|||<|0.001|TWO_SIDED|95.0|1.8|3.1|||Regression, Logistic|||||3.1|1.8|<0.001
72455873|NCT02605174|144434812|SUPERIORITY||Odds Ratio (OR)|0.7||||0.002|TWO_SIDED|95.0|0.5|0.9|||Regression, Logistic|||||0.9|0.5|0.002
72455874|NCT02605174|144434812|SUPERIORITY||Odds Ratio (OR)|0.5|||<|0.001|TWO_SIDED|95.0|0.4|0.7|||Regression, Logistic|||||0.7|0.4|<0.001
72455875|NCT02605174|144434812|SUPERIORITY||Odds Ratio (OR)|0.3|||<|0.001|TWO_SIDED|95.0|0.3|0.4|||Regression, Logistic|||||0.4|0.3|<0.001
72500157|NCT01262898|144530551|SUPERIORITY_OR_OTHER_LEGACY||Slope|-0.078||||||95.0|-0.171|0.016|||Mixed Models Analysis|||Type 2 Diabetes, Day 28|Intercept estimate was 113.23 and between participant standard deviation was 21.63|0.016|-0.171|
72455876|NCT02605174|144434813|SUPERIORITY||Odds Ratio (OR)|1.0||||0.917|TWO_SIDED|95.0|0.7|1.5|||Regression, Logistic|||||1.5|0.7|0.917
72455877|NCT02605174|144434813|SUPERIORITY||Odds Ratio (OR)|0.7||||0.129|TWO_SIDED|95.0|0.5|1.1|||Regression, Logistic|||||1.1|0.5|0.129
72562992|NCT01876368|144658028|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.19|STANDARD_ERROR_OF_MEAN|0.78|<|0.001|TWO_SIDED|95.0|-4.73|-1.65|||ANCOVA|||||-1.65|-4.73|<0.001
72455878|NCT02605174|144434813|SUPERIORITY||Odds Ratio (OR)|0.8||||0.456|TWO_SIDED|95.0|0.6|1.3|||Regression, Logistic|||||1.3|0.6|0.456
72455879|NCT02605174|144434815|SUPERIORITY||Odds Ratio (OR)|0.9||||0.522|TWO_SIDED|95.0|0.7|1.2|||Regression, Logistic|||||1.2|0.7|0.522
72455880|NCT02605174|144434815|SUPERIORITY||Odds Ratio (OR)|1.1||||0.622|TWO_SIDED|95.0|0.8|1.4|||Regression, Logistic|||||1.4|0.8|0.622
72455881|NCT02605174|144434815|SUPERIORITY||Odds Ratio (OR)|1.0||||0.992|TWO_SIDED|95.0|0.8|1.3|||Regression, Logistic|||||1.3|0.8|0.992
72455882|NCT02605174|144434816|SUPERIORITY||Odds Ratio (OR)|1.4||||0.008|TWO_SIDED|95.0|1.1|1.7|||Regression, Logistic|||||1.7|1.1|0.008
72455883|NCT02605174|144434816|SUPERIORITY||Odds Ratio (OR)|1.6|||<|0.001|TWO_SIDED|95.0|1.3|2.0|||Regression, Logistic|||||2.0|1.3|<0.001
72455884|NCT02605174|144434816|SUPERIORITY||Odds Ratio (OR)|1.6|||<|0.001|TWO_SIDED|95.0|1.3|2.1|||Regression, Logistic|||||2.1|1.3|<0.001
72455885|NCT02605174|144434817|SUPERIORITY||Odds Ratio (OR)|1.4||||0.007|TWO_SIDED|95.0|1.1|1.7|||Regression, Logistic|||||1.7|1.1|0.007
72455886|NCT02605174|144434817|SUPERIORITY||Odds Ratio (OR)|1.7|||<|0.001|TWO_SIDED|95.0|1.3|2.1|||Regression, Logistic|||||2.1|1.3|<0.001
72455887|NCT02605174|144434817|SUPERIORITY||Odds Ratio (OR)|1.8|||<|0.001|TWO_SIDED|95.0|1.4|2.3|||Regression, Logistic|||||2.3|1.4|<0.001
72455888|NCT03737110|144434820|SUPERIORITY||Hazard Ratio (HR)|0.04|||<|0.0001|TWO_SIDED|95.0|0.01|0.18||Two-sided p-value is from the log-rank test stratified by oral corticosteroid use at Run-In Baseline.|Log Rank||Calculated based on a Cox proportional-hazards model with treatment as covariate and stratified by oral corticosteroid use at run-in baseline.|||0.18|0.01|<0.0001
72455889|NCT03737110|144434821|SUPERIORITY||Odds Ratio (OR)|12.727||||0.0002|TWO_SIDED|95.0|2.438|66.428||95% confidence interval (CI) and p-value were analyzed using a Cochran-Mantel-Haenszel test adjusted by oral corticosteroid use and diagnosis of recurrent idiopathic pericarditis at run-in baseline.|Cochran-Mantel-Haenszel|||||66.428|2.438|0.0002
72455890|NCT03737110|144434821|SUPERIORITY||Difference in percentages|61.0|||||TWO_SIDED|95.0|36.7|85.2|||||Differences between percentages are reported in percentage points. The 95% confidence intervals for the differences in percentages were based on a normal approximation.|||85.2|36.7|
72455891|NCT03737110|144434822|SUPERIORITY||Least squares (LS) mean difference|51.2|||<|0.0001|TWO_SIDED|95.0|34.5|68.0||Two-sided p-value calculated using analysis of covariance with treatment, randomization strata and run-in baseline NRS weekly average category (NRS ≤ 2 versus NRS \>2) as covariates.|ANCOVA||Least squares mean difference (rilonacept - placebo)|||68.0|34.5|< 0.0001
72455892|NCT03737110|144434823|SUPERIORITY||Odds Ratio (OR)|10.0||||0.0006|TWO_SIDED|95.0|2.136|46.826||95% CI and p-value are analyzed using a Cochran-Mantel-Haenszel test adjusted by oral corticosteroid use and diagnosis of recurrent idiopathic pericarditis at RI baseline.|Cochran-Mantel-Haenszel|||||46.826|2.136|0.0006
72500158|NCT00331760|144530623|SUPERIORITY|||||||0.12|||||||Chi-squared|||A sample size of 42 patients provides 64% power to detect a reduction in short-term grade 2 or higher bowel AEs from historical rate of 40% to 25%.||||0.12
72500159|NCT00331760|144530623|SUPERIORITY|||||||0.043|||||||Chi-squared|||A sample size of 42 patients provides 88% power to detect a reduction in short-term grade 2 or higher bowel AEs from historical rate of 40% to 20%.||||0.043
72455893|NCT03737110|144434823|SUPERIORITY||Difference in percentages|56.0|||||TWO_SIDED|95.0|30.6|81.3|||||Differences between percentages are reported in percentage points. The 95% confidence intervals for the differences in percentages were based on a normal approximation.|||81.3|30.6|
72455894|NCT03737110|144434824|SUPERIORITY||Odds Ratio (OR)|8.37||||0.0022|TWO_SIDED|95.0|1.317|53.188||95% CI and p-value were analyzed using a Cochran-Mantel-Haenszel test adjusted by oral corticosteroid use and diagnosis of recurrent idiopathic pericarditis at run-in baseline.|Cochran-Mantel-Haenszel|||||53.188|1.317|0.0022
72455895|NCT03737110|144434825|SUPERIORITY||Odds Ratio (OR)|10.906|||<|0.0001|TWO_SIDED|95.0|3.051|38.981||95% CI and p-value were analyzed using a Cochran-Mantel-Haenszel test adjusted by oral corticosteroid use and diagnosis of recurrent idiopathic pericarditis at run-in baseline.|Cochran-Mantel-Haenszel|||||38.981|3.051|< 0.0001
72455896|NCT03737110|144434826|SUPERIORITY||LS mean difference|51.9|||<|0.0001|TWO_SIDED|95.0|33.8|70.1||Two-sided p-value calculated using analysis of covariance with treatment, randomization strata and run-in baseline NRS weekly average category (NRS ≤ 2 versus NRS \>2) as covariates.|ANCOVA||Least squares mean difference (rilonacept - placebo)|||70.1|33.8|< 0.0001
72455897|NCT03737110|144434827|SUPERIORITY||LS mean difference|40.5|||<|0.0001|TWO_SIDED|95.0|25.3|55.8||Two-sided p-value calculated using analysis of covariance with treatment, randomization strata and run-in baseline NRS weekly average category (NRS ≤ 2 versus NRS \>2) as covariates.|ANCOVA||Least squares mean difference (rilonacept - placebo)|||55.8|25.3|< 0.0001
72455898|NCT03737110|144434828|SUPERIORITY||Odds Ratio (OR)|30.522||||0.0002|TWO_SIDED|95.0|4.262|218.552||95% CI and p-value are analyzed using a Cochran-Mantel-Haenszel (CMH) test adjusted by oral corticosteroid use at RI baseline.|Cochran-Mantel-Haenszel|||||218.552|4.262|0.0002
72455899|NCT03737110|144434829|SUPERIORITY||Odds Ratio (OR)|14.432|||<|0.0001|TWO_SIDED|95.0|3.439|60.574||95% CI and p-value are analyzed using a Cochran-Mantel-Haenszel test adjusted by oral corticosteroid use and diagnosis of recurrent idiopathic pericarditis at RI baseline.|Cochran-Mantel-Haenszel|||||60.574|3.439|< 0.0001
72455900|NCT03737110|144434830|SUPERIORITY||Difference|75.7|||<|0.0001|TWO_SIDED|95.0|56.8|94.6|||normal approximation|||||94.6|56.8|< 0.0001
72455901|NCT03737110|144434831|SUPERIORITY||Hazard Ratio (HR)|0.13|||<|0.0001|TWO_SIDED|95.0|0.05|0.32||Two-sided p-value is from the log-rank test stratified by oral corticosteroid use at run-in baseline.|Log Rank||Calculated based on a Cox proportional hazards model with treatment as covariate and stratified by oral corticosteroid use at run-in baseline.|||0.32|0.05|< 0.0001
72455902|NCT03737110|144434832|SUPERIORITY||Hazard Ratio (HR)|0.07|||<|0.0001|TWO_SIDED|95.0|0.02|0.22||Two-sided p-value is from the log-rank test stratified by oral corticosteroid use at run-in baseline.|Log Rank||Calculated based on a Cox proportional hazards model with treatment as covariate and stratified by oral corticosteroid use at run-in baseline.|||0.22|0.02|< 0.0001
72455903|NCT03737110|144434833|SUPERIORITY||Hazard Ratio (HR)|0.74||||0.7447|TWO_SIDED|95.0|0.12|4.46||Two-sided p-value is from the log-rank test without stratification by randomization strata.|Log Rank||Calculated based on a Cox proportional-hazards model with treatment as covariate and without stratification by randomization strata.|||4.46|0.12|0.7447
72455904|NCT03737110|144434834|SUPERIORITY||Hazard Ratio (HR)|0.36||||0.2066|TWO_SIDED|95.0|0.07|1.87||Two-sided p-value is from the log-rank test without stratification by randomization strata.|Log Rank||Calculated based on a Cox proportional-hazards model with treatment as covariate and without stratification by randomization strata.|||1.87|0.07|0.2066
72455905|NCT03737110|144434835|SUPERIORITY||Hazard Ratio (HR)|0.0||||0.0059|TWO_SIDED|95.0|0.0||Not estimable due to low number of participants with an event.|Two-sided p-value is from the log-rank test without stratification by randomization strata.|Log Rank||||||0.00|0.0059
72455906|NCT03737110|144434847|SUPERIORITY||Odds Ratio (OR)|0.015|||<|0.0001|TWO_SIDED|95.0|0.002|0.108||Two-sided p value calculated using a Cochran-Mantel-Haenszel test adjudicated by randomization strata.|Cochran-Mantel-Haenszel|||Participants who used ORT, corticosteroids or bailout rilonacept during the RW Period||0.108|0.002|< 0.0001
72455907|NCT01640288|144434963|OTHER|t-test|Mean Difference (Final Values)|-0.145|STANDARD_ERROR_OF_MEAN|0.0349|<|0.0001|TWO_SIDED|||||Not adjusted for multiple comparisons|t-test, 2 sided|||||||<0.0001
72455908|NCT01640288|144434964|OTHER|t-test|Mean Difference (Final Values)|0.178|STANDARD_ERROR_OF_MEAN|0.037|<|0.0001|TWO_SIDED||||||t-test, 2 sided|||||||<0.0001
72455909|NCT04803734|144434966|EQUIVALENCE|To establish bioequivalence of albuterol under fasting conditions, the 90% confidence interval for the ratio of the geometric means between the products should fall within the FDA defined acceptance range of 80.00%-125.00% interval for ln-transformed Cmax.|Ratio of geometric least square mean|0.862||||0.0328|TWO_SIDED|90.0|0.807|0.922|||ANOVA|||||0.922|0.807|0.0328
72455910|NCT04803734|144434967|EQUIVALENCE|To establish bioequivalence of albuterol under fasting conditions, the 90% confidence interval for the ratio of the geometric means between the products should fall within the FDA defined acceptance range of 80.00%-125.00% interval for ln-transformed AUC(0-t).|Ratio of geometric least square mean|0.941|||<|0.0001|TWO_SIDED|90.0|0.909|0.976|||ANOVA|||||0.976|0.909|<0.0001
72455911|NCT04803734|144434968|EQUIVALENCE|To establish bioequivalence of albuterol under fasting conditions, the 90% confidence interval for the ratio of the geometric means between the products should fall within the FDA defined acceptance range of 80.00%-125.00% interval for ln-transformed AUC(0-inf).|Ratio of geometric least square mean|0.942|||<|0.0001|TWO_SIDED|90.0|0.91|0.975|||ANOVA|||||0.975|0.910|<0.0001
72455912|NCT03883724|144434973|OTHER|ANCOVA between-group analysis was completed comparing of Pre- to Post-Intervention change adjusting for baseline value of the outcome||||||0.3|||||||ANCOVA|between-group analysis was completed comparing of Pre- to Post-Intervention change adjusting for baseline value of the outcome||Change in NPi pre- vs post-intervention comparing between group analysis||||0.3
72622494|NCT02544763|144774966|SUPERIORITY||Treatment ratio|0.709|||=|0.0013|TWO_SIDED|95.0|0.576|0.873|||Mixed Models Analysis|||||0.873|0.576|=0.0013
72455913|NCT03883724|144434974|OTHER|ANCOVA between-group analysis was completed comparing of Pre- to Post-Intervention change adjusting for baseline value of the outcome|||||<|0.01||||||Change in nocturia frequency pre- vs post-intervention comparing between groups BBTI vs IC|ANCOVA|between-group analysis was completed comparing of Pre- to Post-Intervention change adjusting for baseline value of the outcome||Change in nocturia frequency pre- vs post-intervention comparing between group analysis||||<.01
72622495|NCT02544763|144774966|SUPERIORITY||Treatment ratio|0.716|||=|0.0018|TWO_SIDED|95.0|0.582|0.882|||Mixed Models Analysis|||||0.882|0.582|=0.0018
72622496|NCT00057577|144774973|SUPERIORITY_OR_OTHER||||||=|0.038|TWO_SIDED||||||Subdistribution hazard model|||||||=.038
72455914|NCT03883724|144434975|OTHER|ANCOVA between-group analysis was completed comparing of Pre- to Post-Intervention change adjusting for baseline value of the outcome||||||0.3|||||||ANCOVA|ANCOVA between-group analysis was completed comparing of Pre- to Post-Intervention change adjusting for baseline value of the outcome||between-group analysis was completed comparing of Pre- to Post-Intervention change adjusting for baseline value of the outcome||||0.3
72455915|NCT00195819|144434976|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|20.1||||0.06||95.0|-0.5|40.7|||Chi-squared|||||40.7|-0.5|0.060
72455916|NCT00195819|144435019|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.4|STANDARD_ERROR_OF_MEAN|0.42||0.387||95.0|||||ANCOVA|||||||0.387
72455917|NCT00822900|144435036|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.95||||0.35|TWO_SIDED|95.0|0.85|1.06|||Regression, Generalized linear|Adjusting for injury severity, sex, and age. the binomial distribution with the log link is used to estimate treatment effect as relative risk.|A risk ratio (equivalent to the relative risk) of less than 1.00 indicating fewer favorable outcomes in the progesterone group than in the placebo group.|Test of null hypothesis (equal proportions of subjects with favorable outcome in progesterone and placebo arms) versus alternative hypothesis (unequal proportions of subjects with favorable outcome in progesterone and placebo arms). Standard multiple imputation methods are used to account for missing data. The primary outcome measure is based on the stratified dichotomy approach.||1.06|0.85|0.35
72455918|NCT00822900|144435037|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.19|||||TWO_SIDED|95.0|0.86|1.63|||||A hazard ratio of more than 1.00 indicating higher hazard of death from the progesterone group than in the placebo group.|The Cox proportional hazards model is used to compare these curves after adjustment for age, sex and injury severity.||1.63|0.86|
72455919|NCT00822900|144435039|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|3.03|||||TWO_SIDED|95.0|1.96|4.66|||||A risk ratio (equivalent to the relative risk) of more than 1.00 indicating more events in the progesterone group than in the placebo group.|||4.66|1.96|
72455920|NCT02095678|144435048|OTHER|Significance (alpha) set to 0.05||||||0.211|||||||t-test, 2 sided|||||||0.211
72455921|NCT02095678|144435051|OTHER|Significance (alpha) set to 0.05|||||<|0.01|||||||t-test, 2 sided|||||||<0.01
72455922|NCT02095678|144435052|OTHER|Significance (alpha) set to 0.05|||||<|0.01|||||||t-test, 2 sided|||||||<0.01
72455923|NCT02397707|144435097|OTHER||Geometric Least-Square Mean (GLSM)Ratio%|411.62|||||TWO_SIDED|90.0|214.72|789.08||||||An analysis of variance (ANOVA) appropriate for a parallel design was fitted to the natural logarithmic transformation of voxilaprevir AUClast. A 90% confidence interval (CI) was constructed for the geometric least squares mean (GLSM) ratio of AUClast for the comparison groups using two 1-sided tests.||789.08|214.72|
72455924|NCT02397707|144435097|OTHER||GLSM Ratio (%)|644.15|||||TWO_SIDED|90.0|364.67|1137.82||||||An ANOVA appropriate for a parallel design was fitted to the natural logarithmic transformation of voxilaprevir AUClast. A 90% CI was constructed for the GLSM ratio of AUClast for the comparison groups using two 1-sided tests.||1137.82|364.67|
72455925|NCT02397707|144435098|OTHER||GLSM Ratio (%)|399.24|||||TWO_SIDED|90.0|210.89|755.81||||||An ANOVA appropriate for parallel design was fitted to the natural logarithmic transformation of voxilaprevir AUCinf. A 90% CI was constructed for the GLSM ratio of AUClast for the comparison groups using two 1-sided tests.||755.81|210.89|
72455926|NCT02397707|144435098|OTHER||GLSM Ratio (%)|599.63|||||TWO_SIDED|90.0|342.36|1050.22||||||An ANOVA appropriate for parallel design was fitted to the natural logarithmic transformation of voxilaprevir AUCinf. A 90% CI was constructed for the GLSM ratio of AUCinf for the comparison groups using two 1-sided tests.||1050.22|342.36|
72455927|NCT02397707|144435099|OTHER||GLSM Ratio (%)|338.41|||||TWO_SIDED|90.0|168.96|677.79||||||An ANOVA appropriate was fitted to the natural logarithmic transformation of voxilaprevir Cmax. A 90% CI was constructed for the GLSM ratio of AUClast for the comparison groups using two 1-sided tests.||677.79|168.96|
72455928|NCT02397707|144435099|OTHER||GLSM Ratio (%)|713.92|||||TWO_SIDED|90.0|384.07|1327.06||||||An ANOVA appropriate was fitted to the natural logarithmic transformation of voxilaprevir Cmax. A 90% CI was constructed for the GLSM ratio of AUClast for the comparison groups using two 1-sided tests.||1327.06|384.07|
72455929|NCT01604824|144435100|SUPERIORITY||LS Mean Difference|-53.72|STANDARD_ERROR_OF_MEAN|11.486|=|0.0009|TWO_SIDED|95.0|-79.31|-28.12||Threshold for significance ≤ 0.05|ANCOVA|||||-28.12|-79.31|= 0.0009
72562993|NCT05766787|144658042|NON_INFERIORITY|Noninferiority in distance VA was declared if upper confidence limit was less than 0.05.|Least Squares Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.003|||ONE_SIDED|95.0||-0.01||Since a noninferiority hypothesis is being tested, a p-value is not applicable. Confidence limit is being reported and compared to the noninferiority margin.|||LSM results based on mixed effects repeated measures model with both fixed (lens, period, sequence, visit, and lens by visit interaction) and random (subject) effects. Difference = LID022821 minus AOHG. Sign is retained with the rounded value.|||-0.01||
72455930|NCT01604824|144435100|SUPERIORITY||LS Mean Difference|-43.28|STANDARD_ERROR_OF_MEAN|10.965|=|0.0056|TWO_SIDED|95.0|-69.21|17.35||Threshold for significance ≤ 0.05|ANCOVA|||||17.35|-69.21|= 0.0056
72455931|NCT01604824|144435101|SUPERIORITY||LS Mean Difference|-49.55|STANDARD_ERROR_OF_MEAN|12.05|=|0.0021|TWO_SIDED|95.0|-76.39|-22.7||Threshold for significance ≤ 0.05|ANCOVA|||LS means (SE), mean difference, 95% CI, and p-values were derived from ANCOVA with treatment group as factor and baseline as covariate.||-22.7|-76.39|= 0.0021
72455932|NCT01604824|144435101|SUPERIORITY||LS Mean Difference|-44.64|STANDARD_ERROR_OF_MEAN|10.876|=|0.0045|TWO_SIDED|95.0|-70.36|18.92||Threshold for significance ≤ 0.05|ANCOVA|||LS means (SE), mean difference, 95% CI, and p-values were derived from ANCOVA with treatment group as factor and baseline as covariate.||18.92|-70.36|= 0.0045
72455933|NCT01604824|144435102|SUPERIORITY||LS Mean Difference|-49.37|STANDARD_ERROR_OF_MEAN|11.487|=|0.0016|TWO_SIDED|95.0|-74.96|-23.77||Threshold for significance ≤ 0.05|ANCOVA|||||-23.77|-74.96|= 0.0016
72562994|NCT01435928|144658053|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.66||||0.039|TWO_SIDED|95.0|0.45|0.98|||Log Rank|||||0.98|0.45|0.039
72622497|NCT00057577|144774974|SUPERIORITY_OR_OTHER||||||<|0.01|||||||Subdistribution hazard model|||||||<0.01
72455934|NCT01604824|144435102|SUPERIORITY||LS Mean Difference|-40.36|STANDARD_ERROR_OF_MEAN|10.471|=|0.0063|TWO_SIDED|95.0|-65.12|15.6||Threshold for significance ≤ 0.05|ANCOVA|||||15.60|-65.12|= 0.0063
72455935|NCT01604824|144435103|SUPERIORITY||LS Mean Difference|-30.75|STANDARD_ERROR_OF_MEAN|7.224|=|0.0017|TWO_SIDED|95.0|-46.85|-14.66||Threshold for significance ≤ 0.05|ANCOVA|||||-14.66|-46.85|= 0.0017
72455936|NCT01604824|144435103|SUPERIORITY||LS Mean Difference|-22.23|STANDARD_ERROR_OF_MEAN|6.294|=|0.0096|TWO_SIDED|95.0|-37.11|-7.34||Threshold for significance ≤ 0.05|ANCOVA|||||-7.34|-37.11|= 0.0096
72455937|NCT01604824|144435104|SUPERIORITY||LS Mean Difference|-49.72|STANDARD_ERROR_OF_MEAN|9.867|=|0.0005|TWO_SIDED|95.0|-71.71|-27.74||Threshold for significance ≤ 0.05|ANCOVA|||||-27.74|-71.71|= 0.0005
72455938|NCT01604824|144435104|SUPERIORITY||LS Mean Difference|-49.33|STANDARD_ERROR_OF_MEAN|11.545|=|0.0037|TWO_SIDED|95.0|-76.63|-22.03||Threshold for significance ≤ 0.05|ANCOVA|||||-22.03|-76.63|= 0.0037
72455939|NCT02502461|144435108|SUPERIORITY||Mean Difference (Final Values)|0.9||||0.04|TWO_SIDED|95.0|0.1|1.7||Bonferroni correction|t-test, 2 sided|||||1.7|0.1|0.04
72455940|NCT03775213|144435110|SUPERIORITY||Risk Ratio (RR)|1.53|||||TWO_SIDED|95.0|0.91|2.58||||||||2.58|.91|
72455941|NCT03775213|144435111|SUPERIORITY||Risk Ratio (RR)|0.97|||||TWO_SIDED|95.0|0.49|1.88||||||Active Monitoring||1.88|.49|
72455942|NCT03775213|144435111|SUPERIORITY||Risk Ratio (RR)|1.06|||||TWO_SIDED|95.0|0.79|1.41||||||Lumpectomy||1.41|.79|
72455943|NCT03775213|144435111|SUPERIORITY||Risk Ratio (RR)|0.9|||||TWO_SIDED|95.0|0.62|1.3||||||Lumpectomy with Radiation||1.30|.62|
72455944|NCT03775213|144435111|SUPERIORITY||Risk Ratio (RR)|0.84|||||TWO_SIDED|95.0|0.48|1.47||||||Mastectomy||1.47|.48|
72455945|NCT03775213|144435112|SUPERIORITY||Risk Ratio (RR)|1.08|||||TWO_SIDED|95.0|0.59|1.98||||||||1.98|.59|
72455946|NCT03775213|144435113|SUPERIORITY||Risk Ratio (RR)|0.96|||||TWO_SIDED|95.0|0.65|1.45||||||||1.45|.65|
72455947|NCT03775213|144435114|SUPERIORITY||Slope|0.09|||||TWO_SIDED|95.0|-0.2|0.38||||||||.38|-.20|
72455948|NCT04821271|144435131|OTHER|Treatment comparison||||||0.91|||||||T-test of estimated marginal means|||The null hypothesis was that there would not be treatment differences in mean MADRS total score. Linear mixed model regression using fixed effects of time, treatment, and a time-by-treatment allowed treatment effect estimates to vary by time. The model also included period specific baseline scores, average per person baseline scores (to avoid cross level bias), and period (first or second). All continuous covariates were mean centered. Alpha level of 0.05, and hypothesis was two-sided.||||0.91
72455949|NCT04821271|144435132|OTHER|Treatment comparison||||||0.47|||||||T-test of estimated marginal means|||The null hypothesis was that there would not be treatment differences in mean MADRS total score. Linear mixed model regression using fixed effects of time, treatment, and a time-by-treatment allowed treatment effect estimates to vary by time. The model also included period specific baseline scores, average per person baseline scores (to avoid cross level bias), and period (first or second). All continuous covariates were mean centered. Alpha level of 0.05, and hypothesis was two-sided.||||0.47
72455950|NCT04821271|144435133|OTHER|Treatment comparison||||||0.14|||||||T-test of estimated marginal means|||The null hypothesis was that there would not be treatment differences in mean MADRS total score. Linear mixed model regression using fixed effects of time, treatment, and a time-by-treatment allowed treatment effect estimates to vary by time. The model also included period specific baseline scores, average per person baseline scores (to avoid cross level bias), and period (first or second). All continuous covariates were mean centered. Alpha level of 0.05, and hypothesis was two-sided.||||0.14
72370434|NCT00488683|144251631|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.01||||0.94||95.0||||Values from Group 1, 2 and 3 were combined for this analysis.|Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccinations and memory B cells at 12 months of age for the serogroup A||||0.94
72455951|NCT04821271|144435134|OTHER|Treatment comparison||||||0.12|||||||T-test of estimated marginal means|||The null hypothesis was that there would not be treatment differences in mean MADRS total score. Linear mixed model regression using fixed effects of time, treatment, and a time-by-treatment allowed treatment effect estimates to vary by time. The model also included period specific baseline scores, average per person baseline scores (to avoid cross level bias), and period (first or second). All continuous covariates were mean centered. Alpha level of 0.05, and hypothesis was two-sided.||||0.12
72455952|NCT04821271|144435135|OTHER|Treatment comparison||||||0.69|||||||T-test of estimated marginal means|||The null hypothesis was that there would not be treatment differences in mean MADRS total score. Linear mixed model regression using fixed effects of time, treatment, and a time-by-treatment allowed treatment effect estimates to vary by time. The model also included period specific baseline scores, average per person baseline scores (to avoid cross level bias), and period (first or second). All continuous covariates were mean centered. Alpha level of 0.05, and hypothesis was two-sided.||||0.69
72455953|NCT04821271|144435136|OTHER|Treatment comparison||||||0.73|||||||T-test of estimated marginal means|||The null hypothesis was that there would not be treatment differences in mean MADRS total score. Linear mixed model regression using fixed effects of time, treatment, and a time-by-treatment allowed treatment effect estimates to vary by time. The model also included period specific baseline scores, average per person baseline scores (to avoid cross level bias), and period (first or second). All continuous covariates were mean centered. Alpha level of 0.05, and hypothesis was two-sided.||||0.73
72455954|NCT04821271|144435137|OTHER|Treatment comparison||||||0.28|||||||T-test of estimated marginal means|||The null hypothesis was that there would not be treatment differences in mean MADRS total score. Linear mixed model regression using fixed effects of time, treatment, and a time-by-treatment allowed treatment effect estimates to vary by time. The model also included period specific baseline scores, average per person baseline scores (to avoid cross level bias), and period (first or second). All continuous covariates were mean centered. Alpha level of 0.05, and hypothesis was two-sided.||||0.28
72455955|NCT04076059|144435151|SUPERIORITY||Cox Proportional Hazard|0.13|||<|0.0001|TWO_SIDED|95.0|0.076|0.222|||Log Rank||Stratified by volume of disease (low vs high) and prior docetaxel use (yes vs no) during screening period.|||0.222|0.076|<0.0001
72455956|NCT04076059|144435152|SUPERIORITY||Cox Proportional Hazard|0.33|||<|0.0001|TWO_SIDED|95.0|0.196|0.556|||Log Rank|Stratified by volume of disease (low vs high) and prior docetaxel use (yes vs no) during screening period.||||0.556|0.196|<0.0001
72455957|NCT04076059|144435153|SUPERIORITY||Cox Proportional Hazard|0.789||||0.7279|TWO_SIDED|95.0|0.208|2.998|||Log Rank|Stratified by volume of disease (low vs high) and prior docetaxel use (yes vs no) during screening period.||||2.998|0.208|0.7279
72455958|NCT04076059|144435154|SUPERIORITY||Cox Proportional Hazard|0.172|||<|0.0001|TWO_SIDED|95.0|0.107|0.276|||Log Rank|Stratified by volume of disease (low vs high) and prior docetaxel use (yes vs no) during screening period.||||0.276|0.107|<0.0001
72455959|NCT04076059|144435155|SUPERIORITY|||||||0.0036|TWO_SIDED|95.0|||||Cochran-Mantel-Haenszel|Stratified by volume of disease and previous docetaxel use during screening period. Parameter estimate: Difference in percentage||||||0.0036
72562995|NCT01435928|144658054|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.75||||0.07|TWO_SIDED|95.0|0.54|1.03|||Log Rank|||||1.03|0.54|0.070
72455960|NCT04076059|144435156|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Cochran-Mantel-Haenszel|Stratified by volume of disease and previous docetaxel use during screening period. Parameter estimate: Difference in percentage||||||<0.0001
72455961|NCT04076059|144435157|SUPERIORITY||Cox Proportional Hazard|0.797||||0.5899|TWO_SIDED|95.0|0.35|1.819|||Log Rank|Stratified by volume of disease (low vs high) and prior docetaxel use (yes vs no) during screening period.||||1.819|0.350|0.5899
72455962|NCT04076059|144435158|SUPERIORITY||Difference in Percentage|53.5|||<|0.0001|TWO_SIDED|95.0|40.1|66.9|||Cochran-Mantel-Haenszel|Stratified by volume of disease and previous docetaxel use during screening period. Parameter estimate: Difference in percentage||||66.9|40.1|<0.0001
72455963|NCT04076059|144435159|SUPERIORITY||Difference in Percentage|-5.2||||0.8312|TWO_SIDED|95.0|-25.4|14.9|||Cochran-Mantel-Haenszel|Stratified by volume of disease and previous docetaxel use during screening period. Parameter estimate: Difference in percentage||||14.9|-25.4|0.8312
72455964|NCT05640167|144435163|OTHER|||||||0.015|||||||t-test, 2 sided|Degrees of freedom 17||||||0.015
72455965|NCT05640167|144435164|OTHER|||||||0.114||||||Positive p = 0.114 Health-directed p = 0.028 Skill and Technique p = 0.013 Constructive attitudes p = 0.003 Self-monitoring \& insight p = 0.001 Health service navigation p = 0.077 Social Integration p = 0.126 Emotional well-being p = 0.093|t-test, 2 sided|||||||0.114
72455966|NCT05640167|144435165|OTHER|||||||0.59|||||||t-test, 2 sided|||||||0.59
72455967|NCT05640167|144435166|OTHER|||||||0.03|||||||t-test, 2 sided|||||||0.03
72455968|NCT05640167|144435167|OTHER|||||||0.309|||||||t-test, 2 sided|||||||0.309
72455969|NCT05640167|144435168|OTHER|||||||0.827|||||||t-test, 2 sided|||||||0.827
72455970|NCT02831816|144435169|NON_INFERIORITY|Investigational product cannot be more than 0.05 log10 cfu/cm2 less than the active control.|Median Difference (Final Values)|-0.02|||||TWO_SIDED|95.0|-0.221|0.18||||||Groin 10 minutes Average treatment effect, calculated using a linear regression model for each body site, was used for primary analysis. In the model, the response was the post-treatment log10 bacterial counts and predictors were the treatment effect as a fixed effect and the pre-treatment log10 bacterial counts as a covariate.||0.180|-0.221|
72455971|NCT02831816|144435169|SUPERIORITY||Median Difference (Final Values)|2.45|||||TWO_SIDED|95.0|2.15|2.76||||||Groin 10 minutes Average Treatment effect, calculated using a linear regression model for each body site, was used for primary analysis. In the model, the response was the post-treatment log10 bacterial counts and predictors were the treatment effect as a fixed effect and the pre-treatment log10 bacterial counts as a covariate.||2.76|2.15|
72455972|NCT02831816|144435170|NON_INFERIORITY|Investigational product cannot be more than 0.05 log10 cfu/cm2 less than the active control.|Mean Difference (Final Values)|-0.0435|||||TWO_SIDED|95.0|-0.2085|0.1215||||||Abdomen 10 minutes average treatment effect, calculated using a linear regression model for each body site, was used for primary analysis. In the model, the response was the post-treatment log10 bacterial counts and predictors were the treatment effect as a fixed effect and the pre-treatment log10 bacterial counts as a covariate.||0.1215|-0.2085|
72455973|NCT02831816|144435170|SUPERIORITY||Mean Difference (Final Values)|1.97|||||TWO_SIDED|95.0|1.7|2.25||||||Abdomen 10 minutes Average Treatment Effect, calculated using a linear regression model for each body site, was used for primary analysis. In the model, the response was the post-treatment log10 bacterial counts and predictors were the treatment effect as a fixed effect and the pre-treatment log10 bacterial counts as a covariate.||2.25|1.70|
72455974|NCT06943638|144435179|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
72455975|NCT00768716|144435197|OTHER|||||||0.52|||||||Wilcoxon (Mann-Whitney)|||||||0.52
72455976|NCT00768716|144435198|OTHER|||||||0.42|||||||Wilcoxon (Mann-Whitney)|||||||0.42
72455977|NCT00768716|144435199|OTHER|||||||0.06|||||||Wilcoxon (Mann-Whitney)|||||||0.06
72455978|NCT00768716|144435201|OTHER||||||<|0.0001|||||||ANOVA|||||||<0.0001
72455979|NCT00768716|144435202|OTHER||||||<|0.0001|||||||ANOVA|||||||<0.0001
72455980|NCT00768716|144435203|OTHER|||||||0.003|||||||ANOVA|||||||0.003
72562996|NCT01435928|144658055|SUPERIORITY_OR_OTHER|||||||0.029|||||||ANCOVA|LOCF||||||0.029
72455981|NCT00799409|144435209|SUPERIORITY_OR_OTHER||LS Mean Difference|-28.6|||<|0.0001|TWO_SIDED|95.0|-35.0|-22.3||P-values were determined by using a repeated measures mixed model with actual value as the dependent variable with terms for treatment, time, treatment by time interaction, period, sequence, and baseline score adjusted by Hochberg's step up procedure|Mixed Models Analysis||Placebo minus CONCERTA|||-22.3|-35.0|<0.0001
72455982|NCT00799409|144435210|SUPERIORITY_OR_OTHER||LS Mean Difference|-28.3|||<|0.0001|TWO_SIDED|95.0|-34.4|-22.2||P-values were determined by using a repeated measures mixed model with actual value as the dependent variable with terms for treatment, time, treatment by time interaction, period, sequence, and baseline score adjusted by Hochberg's step up procedure|Mixed Models Analysis||Placebo minus CONCERTA|||-22.2|-34.4|<0.0001
72455983|NCT00799409|144435211|SUPERIORITY_OR_OTHER||LS Mean Difference|5.9|||<|0.0001|TWO_SIDED|95.0|4.3|7.4||P-Values are determined by using a repeated measures mixed model with actual value as the dependent variable with terms for treatment, time, treatment by time interaction, period, sequence, and baseline score.|Mixed Models Analysis|P-Values at each timepoint are determined by using contrast statements in the repeated measures mixed model.|Placebo minus CONCERTA|||7.4|4.3|<0.0001
72455984|NCT00799409|144435212|SUPERIORITY_OR_OTHER||LS Mean Difference|5.1|||<|0.0001|TWO_SIDED|95.0|3.8|6.5||P-Values are determined by using a repeated measures mixed model with actual value as the dependent variable with terms for treatment, time, treatment by time interaction, period, sequence, and baseline score.|Mixed Models Analysis|P-Values at each timepoint are determined by using contrast statements in the repeated measures mixed model.|Placebo minus CONCERTA|||6.5|3.8|<0.0001
72455985|NCT00799409|144435213|SUPERIORITY_OR_OTHER||LS Mean Difference|11.0|||<|0.0001|TWO_SIDED|95.0|8.7|13.3||P-Values are determined by using a repeated measures mixed model with actual value as the dependent variable with terms for treatment, time, treatment by time interaction, period, sequence, and baseline score.|Mixed Models Analysis|P-Values at each timepoint are determined by using contrast statements in the repeated measures mixed model.|Placebo minus CONCERTA|||13.3|8.7|<0.0001
72455986|NCT00799409|144435214|SUPERIORITY_OR_OTHER||LS Means Difference|-3.16|||<|0.0001|TWO_SIDED|95.0|-3.72|-2.59||P-Values were determined by using a general linear mixed model.|ANCOVA||Placebo minus CONCERTA|||-2.59|-3.72|<0.0001
72455987|NCT00799409|144435215|SUPERIORITY_OR_OTHER||LS Means Difference|-16.03|||<|0.0001|TWO_SIDED|95.0|-19.99|-12.06||P-Values were determined by using a general linear mixed model.|ANCOVA||Placebo minus CONCERTA|||-12.06|-19.99|<0.0001
72455988|NCT00799409|144435216|SUPERIORITY_OR_OTHER||LS Mean Difference|-22.45|||<|0.0001|TWO_SIDED|95.0|-27.43|-17.47||P-Values were determined by using a general linear mixed model.|ANCOVA||Placebo minus CONCERTA|||-17.47|-27.43|<0.0001
72392316|NCT00407797|144292116|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED|95.0|||||t-test, 2 sided|||Percent change from baseline evaluated by a one-sample two-sided t-test comparing the difference to zero.||||<.0001
72392317|NCT00407797|144292117|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED|95.0|||||t-test, 2 sided|||||||<.0001
72392318|NCT00407797|144292118|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED|95.0|||||t-test, 2 sided|||Percent change evaluated by a one-sample two-sided t-test comparing the difference to zero.||||<.0001
72392319|NCT00407797|144292119|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED|95.0|||||t-test, 2 sided|||Participants with \<= 6 seizures during Baseline period.||||<.0001
72392320|NCT00407797|144292119|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED|95.0|||||t-test, 2 sided|||Participants with \> 6 seizures during Baseline Period.||||<.0001
72392321|NCT00407797|144292125|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0552|TWO_SIDED|95.0|||||t-test, 2 sided|||Week 21: Sleep Disturbance. Change from baseline evaluated by a one-sample two-sided t-test comparing the difference to zero.||||0.0552
72392322|NCT00407797|144292125|SUPERIORITY_OR_OTHER_LEGACY|||||||0.035|TWO_SIDED|95.0|||||t-test, 2 sided|||LOCF: Sleep Disturbance. Change from baseline evaluated by a one-sample two-sided t-test comparing the difference to zero.||||0.0350
72392323|NCT00407797|144292125|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6743|TWO_SIDED||||||t-test, 2 sided|||Week 21: Snoring. Change from baseline evaluated by a one-sample two-sided t-test comparing the difference to zero.||||0.6743
72392324|NCT00407797|144292125|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4736|TWO_SIDED||||||t-test, 2 sided|||LOCF: Snoring. Change from baseline evaluated by a one-sample two-sided t-test comparing the difference to zero.||||0.4736
72392325|NCT00407797|144292125|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8173|TWO_SIDED||||||t-test, 2 sided|||Week 21: Awaken Short of Breath. Change from baseline evaluated by a one-sample two-sided t-test comparing the difference to zero.||||0.8173
72392326|NCT00407797|144292125|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9092|TWO_SIDED||||||t-test, 2 sided|||LOCF: Awaken Short of Breath. Change from baseline evaluated by a one-sample two-sided t-test comparing the difference to zero.||||0.9092
72392327|NCT00407797|144292125|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1091|TWO_SIDED||||||t-test, 2 sided|||Week 21: Sleep Adequacy. Change from baseline evaluated by a one-sample two-sided t-test comparing the difference to zero.||||0.1091
72392328|NCT00407797|144292125|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0944|TWO_SIDED||||||t-test, 2 sided|||LOCF: Sleep Adequacy. Change from baseline evaluated by a one-sample two-sided t-test comparing the difference to zero.||||0.0944
72392329|NCT00407797|144292125|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8928|TWO_SIDED||||||t-test, 2 sided|||Week 21: Somnolence. Change from baseline evaluated by a one-sample two-sided t-test comparing the difference to zero.||||0.8928
72392330|NCT00407797|144292125|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7669|TWO_SIDED||||||t-test, 2 sided|||LOCF: Somnolence. Change from baseline evaluated by a one-sample two-sided t-test comparing the difference to zero.||||0.7669
72392331|NCT00407797|144292125|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1698|TWO_SIDED||||||t-test, 2 sided|||Week 21: 9-Item Overall Sleep Problems Index. Change from baseline evaluated by a one-sample two-sided t-test comparing the difference to zero.||||0.1698
72392332|NCT00407797|144292125|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0898|TWO_SIDED||||||t-test, 2 sided|||LOCF: 9-Item Overall Sleep Problem Index. Change from baseline evaluated by a one-sample two-sided t-test comparing the difference to zero.||||0.0898
72392333|NCT00407797|144292125|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0465|TWO_SIDED||||||t-test, 2 sided|||Week 21: Quantity of Sleep. Change from baseline evaluated by a one-sample two-sided t-test comparing the difference to zero.||||0.0465
72392334|NCT00407797|144292125|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0316|TWO_SIDED||||||t-test, 2 sided|||LOCF: Quantity of Sleep. Change from baseline evaluated by a one-sample two-sided t-test comparing the difference to zero.||||0.0316
72392335|NCT00407797|144292126|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2187|TWO_SIDED|95.0|||||t-test, 2 sided|||Week 21; change from baseline evaluated by a one-sample two-sided t-test comparing the difference to zero.||||0.2187
72392336|NCT00407797|144292126|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1905|TWO_SIDED|95.0|||||t-test, 2 sided|||LOCF; change from baseline evaluated by a one-sample two-sided t-test comparing the difference to zero.||||0.1905
72562997|NCT01435928|144658056|SUPERIORITY_OR_OTHER|||||||0.015|||||||ANCOVA|LOCF||||||0.015
72392337|NCT00407797|144292127|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED|95.0|||||t-test, 2 sided|||Anxiety: Week 21. Change from baseline evaluated by a one-sample two-sided t-test comparing the difference to zero.||||<.0001
72392338|NCT00407797|144292127|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED|95.0|||||t-test, 2 sided|||Anxiety: LOCF. Change from baseline evaluated by a one-sample two-sided t-test comparing the difference to zero.||||<.0001
72392339|NCT00407797|144292127|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0799|TWO_SIDED||||||t-test, 2 sided|||Depression: Week 21. Change from baseline evaluated by a one-sample two-sided t-test comparing the difference to zero.||||0.0799
72392340|NCT00407797|144292127|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0846|TWO_SIDED||||||t-test, 2 sided|||Depression: LOCF. Change from baseline evaluated by a one-sample two-sided t-test comparing the difference to zero.||||0.0846
72392341|NCT03782792|144292134|OTHER||Risk Difference (RD)|0.487||||0.0004|TWO_SIDED|95.0|0.215|0.672||One-sided P Value.|Suissa-Shuster Z-pooled test||Risk difference=Response rate of spesolimab - response rate of placebo.|The Suissa-Shuster Z-pooled test was implemented to test the treatment effect on the primary endpoint on the RS (estimand EN) at a 1-sided, alpha level of 0.025. Confidence intervals (95%) around the risk difference were produced using the Chan and Zhang method.||0.672|0.215|0.0004
72392342|NCT03782792|144292135|OTHER||Risk Difference (RD)|0.317||||0.0118|TWO_SIDED|95.0|0.022|0.527||One-sided P Value.|Suissa-Shuster Z-pooled test||Risk difference=Response rate of spesolimab - response rate of placebo.|The Suissa-Shuster Z-pooled test was implemented to test the treatment effect on the RS (estimand EN) at a 1-sided, alpha level of 0.025. Confidence intervals (95%) around the risk difference were produced using the Chan and Zhang method.||0.527|0.022|0.0118
72455989|NCT00799409|144435217|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.93||||0.18|TWO_SIDED|95.0|-1.69|-0.16||P-Values were determined by using a general linear mixed model.|ANCOVA||Placebo minus CONCERTA|||-0.16|-1.69|0.1800
72562998|NCT01435928|144658057|SUPERIORITY_OR_OTHER|||||||0.218|||||||ANCOVA|LOCF||||||0.218
72562999|NCT01435928|144658058|SUPERIORITY_OR_OTHER|||||||0.021|||||||ANCOVA|LOCF||||||0.021
72455990|NCT00799409|144435218|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.32||||0.0057|TWO_SIDED|95.0|-2.25|-0.4||P-Values were determined by using a general linear mixed model.|ANCOVA||Placebo minus CONCERTA|||-0.40|-2.25|0.0057
72455991|NCT00799409|144435219|SUPERIORITY_OR_OTHER||LS Mean Difference|-6.3||||0.1091|TWO_SIDED|95.0|-14.05|1.44||P-Values were determined by using a general linear mixed model.|ANCOVA||Placebo minus CONCERTA|||1.44|-14.05|0.1091
72455992|NCT00799409|144435220|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.25||||0.2653|TWO_SIDED|95.0|-0.7|0.2||P-Values were determined by using a general linear mixed model.|ANCOVA||Placebo minus CONCERTA|||0.20|-0.70|0.2653
72455993|NCT00799409|144435221|SUPERIORITY_OR_OTHER||LS Mean Difference|-6.49||||0.0038|TWO_SIDED|95.0|-10.81|-2.17||P-Values were determined by using a general linear mixed model.|ANCOVA||Placebo minus CONCERTA|||-2.17|-10.81|0.0038
72455994|NCT00799409|144435222|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.75||||0.0001|TWO_SIDED|95.0|-6.96|-2.53||P-Values were determined by using a general linear mixed model.|ANCOVA||Placebo minus CONCERTA|||-2.53|-6.96|0.0001
72455995|NCT00799409|144435223|SUPERIORITY_OR_OTHER||LS Mean Difference|-5.76||||0.0092|TWO_SIDED|95.0|-10.04|-1.47||P-Values were determined by using a general linear mixed model.|ANCOVA||Placebo minus CONCERTA|||-1.47|-10.04|0.0092
72455996|NCT00799409|144435224|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.02||||0.9195|TWO_SIDED|95.0|-0.37|0.33||P-Values were determined by using a general linear mixed model.|ANCOVA||Placebo minus CONCERTA|||0.33|-0.37|0.9195
72455997|NCT00799409|144435225|SUPERIORITY_OR_OTHER||LS Mean Difference|-39.55||||0.0002|TWO_SIDED|95.0|-59.7|-19.39||P-Values were determined by using a general linear mixed model.|ANCOVA||Placebo minus CONCERTA|||-19.39|-59.70|0.0002
72455998|NCT00799409|144435226|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.08||||0.0002|TWO_SIDED|95.0|-0.13|-0.04||P-Values were determined by using a general linear mixed model.|ANCOVA||Placebo minus CONCERTA|||-0.04|-0.13|0.0002
72455999|NCT00799409|144435227|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.02||||0.4625|TWO_SIDED|95.0|-0.07|0.03||P-Values were determined by using a general linear mixed model.|ANCOVA||Placebo minus CONCERTA|||0.03|-0.07|0.4625
72456000|NCT00799409|144435228|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.02||||0.6262|TWO_SIDED|95.0|-0.09|0.05||P-Values were determined by using a general linear mixed model.|ANCOVA||Placebo minus CONCERTA|||0.05|-0.09|0.6262
72456001|NCT00799409|144435229|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0||||0.998|TWO_SIDED|95.0|-0.08|0.08||P-Values were determined by using a general linear mixed model.|ANCOVA||Placebo minus CONCERTA|||0.08|-0.08|0.9980
72456002|NCT00799409|144435230|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1||||0.0151|TWO_SIDED|95.0|-0.19|-0.02||P-Values were determined by using a general linear mixed model.|ANCOVA||Placebo minus CONCERTA|||-0.02|-0.19|0.0151
72456003|NCT00799409|144435231|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.09||||0.0043|TWO_SIDED|95.0|-0.15|-0.03||P-Values were determined by using a general linear mixed model.|ANCOVA||Placebo minus CONCERTA|||-0.03|-0.15|0.0043
72456004|NCT00799409|144435232|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.04||||0.0371|TWO_SIDED|95.0|-0.08|0.0||P-Values were determined by using a general linear mixed model.|ANCOVA||Placebo minus CONCERTA|||0.00|-0.08|0.0371
72456005|NCT00799409|144435233|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.03||||0.0965|TWO_SIDED|95.0|-0.06|0.01||P-Values were determined by using a general linear mixed model.|ANCOVA||Placebo minus CONCERTA|||0.01|-0.06|0.0965
72456006|NCT03964974|144435234|SUPERIORITY|2-sided hypothesis tests were utilized to compare ISI score over time in the two treatment conditions.|Median Difference (Final Values)|-4.307|STANDARD_ERROR_OF_MEAN|1.612||0.0041|TWO_SIDED|95.0|-7.51|-1.104||This is the calculated p-value. The threshold for statistical significance was 0.05.|Mixed Models Analysis|||Persons in the CBTI-CB condition were hypothesized as realizing greater reduction in insomnia severity as measured by the Insomnia Severity Index (ISI) over time compared to the Sleep Hygiene Education (SHE) condition. 80% power was estimated to detect a medium or larger effect size (d\>0.52) on sleep- and functioning-related outcomes, even with a more conservative alpha set at 0.017 (i.e., 0.05/3 for the 3 outcomes).|Parameter is estimated difference in final means, CBTi-CB - Control. Minus sign denotes greater decrease for CBTi-CB. Effect size for Time X Condition = 0.81|-1.104|-7.510|0.0041
72456007|NCT02713594|144435235|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-7.86|||<|0.0001|TWO_SIDED|95.0|-11.28|-4.5|||Abstinence Risk Difference|||||-4.5|-11.28|<.0001
72456008|NCT02713594|144435236|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Chi-squared|Chi-square test value = 196.1, with 5 degrees of freedom.||||||<.0001
72456009|NCT01214200|144435250|OTHER|For the analysis of differences between pre and post treatment a student's t-test was used and was checked with the Wilcoxon signed rank test. A p\<0.05 was considered statistically significant.||||||0.01|||||||Wilcoxon Signed Ranks Test|||||||0.01
72456010|NCT01719172|144435258|SUPERIORITY_OR_OTHER||||||<|0.0001||||||The p-value from a one-sided exact test was based on the binomial distribution, testing that the true percent success rate was ≤ 50% versus the alternative hypothesis that the success rate was \> 50%.|t-test, 1 sided|||The primary effectiveness endpoint was the percent (%) success in obtaining hemostasis at the Target Bleeding Site (TBS) within 5 minutes following Veriset™ application. An exact (Clopper-Pearson) 95% confidence interval for the true success percentage was calculated. Subjects who received rescue therapy on the target bleeding site prior to obtaining hemostasis were considered failures.||||<0.0001
72563000|NCT01435928|144658059|SUPERIORITY_OR_OTHER|||||||0.056|||||||ANCOVA|LOCF||||||0.056
72456011|NCT01719172|144435259|SUPERIORITY_OR_OTHER|||||||0.0214||||||The p-value from a one-sided exact test was based on the binomial distribution, testing that the true percent success rate was ≤ 50% versus the alternative hypothesis that the success rate was \> 50%.|t-test, 1 sided|||The number and percentage of subjects who achieved hemostasis within 1 minute were presented. An exact (Clopper-Pearson) 95% confidence interval for the true percentage was calculated.||||0.0214
72456012|NCT01719172|144435260|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|1.0|||||ONE_SIDED|95.0||1.0||||||Time to achieve hemostasis was analyzed using the Kaplan-Meier method to estimate the survival distribution and to obtain the estimated median time to hemostasis. Additionally, A 95% Brookmeyer-Crowley confidence interval for the median was computed based on the sign test.||1.0||
72456013|NCT00770874|144435261|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.125|TWO_SIDED|95.0|0.67|1.05|||Log Rank|||||1.05|0.67|0.125
72456014|NCT00770874|144435262|SUPERIORITY||Hazard Ratio (HR)|0.62|||<|0.001|TWO_SIDED|95.0|0.48|0.8|||Log Rank|||||0.80|0.48|<0.001
72456015|NCT02746107|144435306|NON_INFERIORITY_OR_EQUIVALENCE|details provided in the protocol. Noninferiority margin=+/-5%|Risk Difference (RD)|0.5||||0.83|TWO_SIDED|95.0|-4.0|5.4|||Chi-squared|||||5.4|-4|0.83
72456016|NCT02746107|144435307|SUPERIORITY_OR_OTHER||Risk Difference (RD)|3.4||||0.187|TWO_SIDED|95.0|-1.3|8.1|||Chi-squared||(risk on 5y) - (risk on 1y)|details provided in protocol;||8.1|-1.3|0.187
72456017|NCT02746107|144435308|SUPERIORITY_OR_OTHER||Risk Difference (RD)|15.4|||<|0.001|TWO_SIDED|95.0|10.8|20.0|||Chi-squared||patient - (physicians themselves)|||20|10.8|<0.001
72456018|NCT02746107|144435308|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.28|||<|0.001|TWO_SIDED|95.0|2.25|4.78|||Regression, Logistic|adjustment for age, gender, CHA2D2s-VASC score, nr of diagrams, nr of years, presence of someone close with stroke, graduation year, speciality||||4.78|2.25|<0.001
72456019|NCT02746107|144435309|SUPERIORITY_OR_OTHER||Risk Difference (RD)|9.3||||0.034|TWO_SIDED|95.0|1.2|17.0|||Chi-squared|CHA2D2S-VASC risk score 1 was reference|positive value means higher proportion of prescription, CHA2D2S-VASC risk score 1 was reference|CHA2D2S-VASC risk score 1 was the reference||17|1.2|0.034
72456020|NCT02746107|144435309|SUPERIORITY_OR_OTHER||Risk Difference (RD)|9.2||||0.033|TWO_SIDED|95.0|1.2|17.0|||Chi-squared|||||17|1.2|0.033
72456021|NCT02746107|144435309|SUPERIORITY_OR_OTHER||Risk Difference (RD)|12.4||||0.003|TWO_SIDED|95.0|4.7|20.1|||Chi-squared|||||20.1|4.7|0.003
72456022|NCT02746107|144435309|SUPERIORITY_OR_OTHER||Risk Difference (RD)|11.1||||0.009|TWO_SIDED|95.0|3.2|18.8|||Chi-squared|||||18.8|3.2|0.009
72456023|NCT02746107|144435309|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.82||||0.024|TWO_SIDED|95.0|1.08|3.07|||Regression, Logistic|CHA2D2S-VASC risk score 1 was the reference, adjusted for nr diagrams, nr years, age, gender, smb close with stroke, speciality, professional degree||CHA2D2S-VASC risk score 1 was the reference||3.07|1.08|0.024
72456024|NCT02746107|144435309|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.77||||0.03|TWO_SIDED|95.0|1.06|2.98|||Regression, Logistic|Adjusted for age, gender, medical and academic degrees, someone close with stroke, speciality, period of risk estimation, number of figures.|numerator: CHADS-VASC 1|||2.98|1.06|0.03
72456025|NCT02746107|144435309|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.37||||0.002|TWO_SIDED|95.0|1.37|4.09|||Regression, Logistic|Adjusted for age, gender, medical and academic degrees, someone close with stroke, speciality, period of risk estimation, number of figures.|numerator = CHADS-VASC 1|||4.09|1.37|0.002
72456026|NCT02746107|144435309|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.19||||0.004|TWO_SIDED|95.0|1.14|2.56|||Regression, Logistic|Adjusted for age, gender, medical and academic degrees, someone close with stroke, speciality, period of risk estimation, number of figures.|numerator=CHADS-VASC 1|||2.56|1.14|0.004
72456027|NCT00403494|144435324|SUPERIORITY|PWT was transformed to the log ratio at Week 24:Baseline for statistical analysis.|Mean Difference (Final Values)|-0.021|STANDARD_DEVIATION|0.379||0.727|TWO_SIDED|95.0|-0.138|0.097|||t-test, 2 sided||Mean difference represents the difference of the means of the natural log-transformed ratios between the 2 treatment groups.|||0.097|-0.138|0.727
72456028|NCT00047385|144435328|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.8||||0.004|TWO_SIDED|95.0|0.733|0.932||P-value is adjusted for multiple comparisons.|Weighted log-rank (details below)|Weights in weighted log-rank statistic increased linearly from zero at randomization to full weight at 4 years and thereafter.||"Alternative hypothesis: LDCT screening reduces lung cancer mortality relative to chest x-ray.~Power: 90% for a 20% reduction in lung cancer mortality."||0.932|0.733|0.004
72456029|NCT00047385|144435329|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.933||||0.02|TWO_SIDED|95.0|0.864|0.988||No adjustment for multiple comparisons. Only one analysis performed.|Weighted log-rank (details below)|Weights in weighted log-rank statistic increased linearly from zero at randomization to full weight at 4 years and thereafter.||Alternative hypothesis: LDCT screening reduced all-cause mortality relative to chest x-ray.||0.988|0.864|0.02
72456030|NCT00047385|144435330|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.13|||||TWO_SIDED|95.0|1.03|1.23|||||Denominator: LDCT Group Numerator: CXR Group|||1.23|1.03|
72456031|NCT01852045|144435352|SUPERIORITY||Least Squares Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.276||0.9949|TWO_SIDED|95.0|-0.549|0.545|||ANCOVA||Least squares estimates and contrast t-test were based on ANCOVA model with baseline value as covariate and treatment group, age, baseline daytime urinary incontinence episodes, anticholinergic therapy at baseline as factors.|||0.545|-0.549|0.9949
72456032|NCT01852045|144435352|SUPERIORITY||Least Squares Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.321||0.9123|TWO_SIDED|95.0|-0.673|0.602|||ANCOVA||Least squares estimates and contrast t-test were based on ANCOVA model with baseline value as covariate and treatment group, age, baseline daytime urinary incontinence episodes, anticholinergic therapy at baseline as factors.|||0.602|-0.673|0.9123
72456033|NCT01852045|144435354|SUPERIORITY||Least Squares Mean Difference|12.97|STANDARD_ERROR_OF_MEAN|19.694||0.5117|TWO_SIDED|95.0|-26.12|52.064|||ANCOVA||Least squares estimates and contrast t-test are based on ANCOVA model with baseline value as covariate and treatment group, age, baseline daytime urinary incontinence episodes, anticholinergic therapy at baseline as factors.|||52.064|-26.120|0.5117
72456034|NCT01852045|144435354|SUPERIORITY||Least Squares Mean Difference|65.57|STANDARD_ERROR_OF_MEAN|23.101||0.0055|TWO_SIDED|95.0|19.711|111.421|||ANCOVA||Least squares estimates and contrast t-test are based on ANCOVA model with baseline value as covariate and treatment group, age, baseline daytime urinary incontinence episodes, anticholinergic therapy at baseline as factors.|||111.421|19.711|0.0055
72456035|NCT01852045|144435356|SUPERIORITY||Least Squares Mean Difference|-13.49|STANDARD_ERROR_OF_MEAN|19.673||0.4948|TWO_SIDED|95.0|-52.605|25.626|||ANCOVA||Least squares estimates and contrast t-test are based on ANCOVA model with baseline value as covariate and treatment group, age, baseline daytime urinary incontinence episodes, anticholinergic therapy at baseline as factors.|||25.626|-52.605|0.4948
72456036|NCT01852045|144435356|SUPERIORITY||Least Squares Mean Difference|1.49|STANDARD_ERROR_OF_MEAN|22.382||0.9471|TWO_SIDED|95.0|-43.012|45.991|||ANCOVA||Least squares estimates and contrast t-test are based on ANCOVA model with baseline value as covariate and treatment group, age, baseline daytime urinary incontinence episodes, anticholinergic therapy at baseline as factors.|||45.991|-43.012|0.9471
72456037|NCT01852045|144435357|SUPERIORITY||Relative Risk|0.7||||0.2027|TWO_SIDED|95.0|0.45|1.14||P-values for pairwise comparisons are obtained from 2-sided CMH test, stratified by age (\<12 years or \>=12 years), baseline daytime urinary incontinence episodes (\<=6 or \>6) and anticholinergic therapy (yes/no).|Cochran-Mantel-Haenszel|||Week 6||1.14|0.45|0.2027
72392343|NCT03782792|144292136|OTHER||Risk Difference (RD)|0.346||||0.0081|TWO_SIDED|95.0|0.058|0.554||One-sided P Value.|Suissa-Shuster Z-pooled test||Risk difference=Response rate of spesolimab - response rate of placebo.|The Suissa-Shuster Z-pooled test was implemented to test the treatment effect on the RS (estimand EN) at a 1-sided, alpha level of 0.025. Confidence intervals (95%) around the risk difference were produced using the Chan and Zhang method.||0.554|0.058|0.0081
72620681|NCT01423084|144772411|NON_INFERIORITY_OR_EQUIVALENCE|Two different lots of rMenB+OMV NZ are to be considered equivalent in terms of hSBA GMTs against NZ 98/254 strain if the two sided 95% Confidence Interval (CI) between groups GMTs ratio at day 31 (ie, one month after the second vaccination ) does not exceed the range 0.5 (lower limit) - 2.0 (higher limit).|between groups ratio|0.81|||||TWO_SIDED|95.0|0.6|1.09||||||Equivalence of 2 different lots of rMenB+OMV NZ in terms of hSBA GMTs against NZ98/254 strain||1.09|0.6|
72456038|NCT01852045|144435357|SUPERIORITY||Relative Risk|0.8||||0.1564|TWO_SIDED|95.0|0.4|1.21||P-values for pairwise comparisons are obtained from a 2-sided CMH test, stratified by age (\< 12 years or \>= 12 years), baseline daytime urinary incontinence episodes (\<= 6 or \> 6) and anticholinergic therapy (yes/no).|Cochran-Mantel-Haenszel|||Week 6||1.21|0.40|0.1564
72456039|NCT01852045|144435358|SUPERIORITY||Least Squares Mean Difference|-4.49|STANDARD_ERROR_OF_MEAN|7.488||0.5524|TWO_SIDED|95.0|-19.648|10.669|||ANCOVA||Least squares estimates and contrast t-test are based on ANCOVA model with baseline value as covariate and treatment group, age, baseline daytime urinary incontinence episodes, anticholinergic therapy at baseline as factors.|||10.669|-19.648|0.5524
72456040|NCT01852045|144435358|SUPERIORITY||Least Squares Mean Difference|2.18|STANDARD_ERROR_OF_MEAN|10.181||0.8313|TWO_SIDED|95.0|-18.427|22.795|||ANCOVA||Least squares estimates and contrast t-test are based on ANCOVA model with baseline value as covariate and treatment group, age, baseline daytime urinary incontinence episodes, anticholinergic therapy at baseline as factors.|||22.795|-18.427|0.8313
72456041|NCT01852045|144435359|SUPERIORITY||Least Squares Mean Difference|-7.21|STANDARD_ERROR_OF_MEAN|5.253||0.1737|TWO_SIDED|95.0|-17.653|3.238|||ANCOVA||Least squares estimates and contrast t-test are based on ANCOVA model with baseline value as covariate and treatment group, age, baseline daytime urinary incontinence episodes, anticholinergic therapy at baseline as factors.|||3.238|-17.653|0.1737
72456042|NCT01852045|144435359|SUPERIORITY||Least Squares Mean Difference|-14.43|STANDARD_ERROR_OF_MEAN|5.85||0.0157|TWO_SIDED|95.0|-26.061|-2.793|||ANCOVA||Least squares estimates and contrast t-test are based on ANCOVA model with baseline value as covariate and treatment group, age, baseline daytime urinary incontinence episodes, anticholinergic therapy at baseline as factors.|||-2.793|-26.061|0.0157
72456043|NCT03052517|144435383|OTHER||Hazard Ratio (HR)|0.86|||||TWO_SIDED|95.0|0.74|1.0|||Regression, Cox|The Cox regression model = treatment group+ severity of asthma + region as fixed class effects, stratified by randomization stratum|A hazard ratio \< 1 favors the treatment group in the numerator of the ratio.|Hazard Ratio = QAW039 150mg / Placebo||1.00|0.74|
72456044|NCT03052517|144435383|OTHER||Hazard Ratio (HR)|0.84|||||TWO_SIDED|95.0|0.72|0.97|||Regression, Cox|The Cox regression model = treatment group+ severity of asthma + region as fixed class effects, stratified by randomization stratum|A hazard ratio \< 1 favors the treatment group in the numerator of the ratio.|Hazard Ratio = QAW039 450mg / Placebo||0.97|0.72|
72456045|NCT03052517|144435383|OTHER||Hazard Ratio (HR)|0.97|||||TWO_SIDED|95.0|0.87|1.09|||Regression, Cox|The Cox regression model = treatment group+ severity of asthma + region as fixed class effects, stratified by randomization stratum|A hazard ratio \< 1 favors the treatment group in the numerator of the ratio.|Hazard Ratio = QAW039 450mg / QAW039 150mg||1.09|0.87|
72500160|NCT00461175|144530631|NON_INFERIORITY_OR_EQUIVALENCE|Sample size calculations were based on a two group test of equivalence in proportions. These calculations are based on the following assumptions: 1) one sided α of 0.025; 2) power (1-β) of 0.80; 3) non-inferiority limit on hazard ratio of 2; and 4) an incidence of 0.5 and 1.0 per 1000 insertions.|Hazard Ratio (HR)|1.61|||||TWO_SIDED|95.0|0.96|2.7|||||Hazard ratio was adjusted for the following prognostic factors: age, BMI, breastfeeding at time of insertion and parity status.|The null hypothesis to be tested was: The perforation incidence ratio for LNG IUS vs. copper IUD is higher than or equal to 2.||2.70|0.96|
72500161|NCT00461175|144530631|NON_INFERIORITY_OR_EQUIVALENCE|Sample size calculations were based on a two group test of equivalence in proportions. These calculations are based on the following assumptions: 1) one sided α of 0.025; 2) power (1-β) of 0.80; 3) non-inferiority limit on hazard ratio of 2; and 4) an incidence of 0.5 and 1.0 per 1000 insertions.|Hazard Ratio (HR)|1.65|||||TWO_SIDED|95.0|0.99|2.78|||||Hazard ratio was adjusted for the following prognostic factors: age, BMI, time since last delivery, experience of the inserting health care provider.|The null hypothesis to be tested was: The perforation incidence ratio for LNG IUS vs. copper IUD is higher than or equal to 2.||2.78|0.99|
72500162|NCT00461175|144530632|SUPERIORITY_OR_OTHER||Pearl Index|0.06|||||TWO_SIDED|95.0|0.04|0.09||||||||0.09|0.04|
72500163|NCT00461175|144530632|SUPERIORITY_OR_OTHER||Pearl Index|0.52|||||TWO_SIDED|95.0|0.42|0.64||||||||0.64|0.42|
72500164|NCT00461175|144530632|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.16|||||TWO_SIDED|95.0|0.1|0.25|||||Hazard ratio was adjusted for the following prognostic factors: age, BMI, and parity.|||0.25|0.10|
72500165|NCT02514044|144530633|OTHER|"We also performed normalization by calculating the dependent variable as the percentage of change (proportional change) as it follows; (1) (post-active values - pre-active values)/ (pre-active values) and (2) (post-placebo values - pre-placebo values)/ (pre-placebo series). We compared the percentage of change in Bedside WAB-R® aphasia and language quotients and blood pressures for the experiments with active- and placebo drugs combined active tDCS with MIT using a two-tailed paired t-test."||||||0.008|||||||t-test, 2 sided|||We tested normality using the Kolmogorov-Smirnov (KS) test for all reported measures. We compared scores of Bedside WAB-R® subtests Bedside WAB-R® AQ and LQ from before the study intervention and after the intervention in both experiments by using a two-tailed and paired t-test.||||0.008
72620682|NCT01423084|144772419|NON_INFERIORITY_OR_EQUIVALENCE|Two different lots of rMenB+OMV NZ are to be considered equivalent in terms of ELISA GMCs against vaccine antigen 287-953 if the two sided 95% Confidence Interval (CI) between groups GMTs ratio at day 31 (ie, one month after the second vaccination ) does not exceed the range 0.5 (lower limit) - 2.0 (higher limit).|between groups ratio|0.83|||||TWO_SIDED|95.0|0.67|1.02||||||Equivalence of 2 different lots of rMenB+OMV NZ in terms of hSBA GMTs||1.02|0.67|
72456046|NCT03052517|144435384|OTHER||Hazard Ratio (HR)|0.88|||||TWO_SIDED|95.0|0.76|1.02|||Regression, Cox|The Cox regression model = treatment group+ severity of asthma + region as fixed class effects, stratified by randomization stratum|A hazard ratio \< 1 favors the treatment group in the numerator of the ratio.|Hazard Ratio = QAW039 150mg / Placebo||1.02|0.76|
72563001|NCT00292227|144658079|NON_INFERIORITY_OR_EQUIVALENCE|A standard deviation of 12ms was assumed for sample size calculation. Sample size was calculated to have 90% power to show the non-inferiority of rotigotine against placebo with respect to the non-inferiority margin of 10ms (α=0.05, 1-sided).|Mean Difference (Net)|-0.75||||||90.0|-2.63|1.12|||ANCOVA|The ANCOVA model included the factors site, treatment, gender, and time-matched baseline QTcI as covariate.|The direction of the estimate is Rotigotine - Placebo. Mean difference was estimated from the ANCOVA model.|The analysis was based on a non-inferiority comparison of rotigotine vs placebo using a 1-sided 95% confidence interval (or, equivalently, the upper limit of 2-sided 90% confidence interval) for the time-matched changes from Baseline in QTcI.||1.12|-2.63|
72563002|NCT00292227|144658080|NON_INFERIORITY_OR_EQUIVALENCE|A standard deviation of 12ms was assumed for sample size calculation. Sample size was calculated to have 90% power to show the non-inferiority of rotigotine against placebo with respect to the non-inferiority margin of 10ms (α=0.05, 1-sided).|Mean Difference (Net)|-0.01||||||90.0|-2.21|2.19|||ANCOVA|The ANCOVA model included the factors site, treatment, gender, and time-matched baseline QTcI as covariate.|The direction of the estimate is Rotigotine - Placebo. Mean difference was estimated from the ANCOVA model.|The analysis was based on a non-inferiority comparison of rotigotine vs placebo using a 1-sided 95% confidence interval (or, equivalently, the upper limit of 2-sided 90% confidence interval) for the time-matched changes from Baseline in QTcI.||2.19|-2.21|
72563003|NCT00292227|144658081|NON_INFERIORITY_OR_EQUIVALENCE|A standard deviation of 12ms was assumed for sample size calculation. Sample size was calculated to have 90% power to show the non-inferiority of rotigotine against placebo with respect to the non-inferiority margin of 10ms (α=0.05, 1-sided).|Mean Difference (Net)|0.84||||||90.0|-1.12|2.8|||ANCOVA|The ANCOVA model included the factors site, treatment, gender, and time-matched baseline QTcI as covariate.|The direction of the estimate is Rotigotine - Placebo Mean difference was estimated from the ANCOVA model.|The analysis was based on a non-inferiority comparison of rotigotine vs placebo using a 1-sided 95% confidence interval (or, equivalently, the upper limit of 2-sided 90% confidence interval) for the time-matched changes from Baseline in QTcI.||2.80|-1.12|
72563004|NCT00292227|144658082|NON_INFERIORITY_OR_EQUIVALENCE|A standard deviation of 12ms was assumed for sample size calculation. Sample size was calculated to have 90% power to show the non-inferiority of rotigotine against placebo with respect to the non-inferiority margin of 10ms (α=0.05, 1-sided).|Mean Difference (Net)|0.26||||||90.0|-1.8|2.32|||ANCOVA|The ANCOVA model included the factors site, treatment, gender, and time-matched baseline QTcI as covariate.|The direction of the estimate is Rotigotine - Placebo. Mean difference was estimated from the ANCOVA model.|The analysis was based on a non-inferiority comparison of rotigotine vs placebo using a 1-sided 95% confidence interval (or, equivalently, the upper limit of 2-sided 90% confidence interval) for the time-matched changes from Baseline in QTcI.||2.32|-1.80|
72563005|NCT00292227|144658083|NON_INFERIORITY_OR_EQUIVALENCE|A standard deviation of 12ms was assumed for sample size calculation. Sample size was calculated to have 90% power to show the non-inferiority of rotigotine against placebo with respect to the non-inferiority margin of 10ms (α=0.05, 1-sided).|Mean Difference (Net)|-0.11||||||90.0|-2.25|2.02|||ANCOVA|The ANCOVA model included the factors site, treatment, gender, and time-matched baseline QTcI as covariate.|The direction of the estimate is Rotigotine - Placebo. Mean difference was estimated from the ANCOVA model.|The analysis was based on a non-inferiority comparison of rotigotine vs placebo using a 1-sided 95% confidence interval (or, equivalently, the upper limit of 2-sided 90% confidence interval) for the time-matched changes from Baseline in QTcI.||2.02|-2.25|
72620683|NCT02462057|144772449|EQUIVALENCE|The anticipated sample size of 3500 provided 80% power to detect a 3% pairwise difference between the proportions of participants who enrolled in HF with significance testing conducted at the Bonferroni-corrected significance level of 0.005 (0.05/10) to account for the 10 pairwise between-arm comparisons and pessimistically allowing for up to 10% further exclusions. The baseline monthly enrolment rate was estimated at ∼1%/month.|||||<|0.0001|||||||Fisher Exact|||||||<0.0001
72620684|NCT02336555|144772460|SUPERIORITY||Mean Difference (Final Values)|-0.452||||0.075|TWO_SIDED|95.0|-1.076|0.172||Linear mixed model with a posterior probability evaluation for the treatment effect|Linear mixed model|One-sided p-value and a posterior probability greater than 90% that the treatment effect is less than 0.||||0.172|-1.076|0.075
72456047|NCT03052517|144435384|OTHER||Hazard Ratio (HR)|0.85|||||TWO_SIDED|95.0|0.73|0.99|||Regression, Cox|The Cox regression model = treatment group+ severity of asthma + region as fixed class effects, stratified by randomization stratum|A hazard ratio \< 1 favors the treatment group in the numerator of the ratio.|Hazard Ratio = QAW039 450mg / Placebo||0.99|0.73|
72456048|NCT03052517|144435384|OTHER||Hazard Ratio (HR)|0.97|||||TWO_SIDED|95.0|0.86|1.08|||Regression, Cox|The Cox regression model = treatment group+ severity of asthma + region as fixed class effects, stratified by randomization stratum|A hazard ratio \< 1 favors the treatment group in the numerator of the ratio.|Hazard Ratio = QAW039 450mg / QAW039 150mg||1.08|0.86|
72456049|NCT03052517|144435385|OTHER||Hazard Ratio (HR)|0.78|||||TWO_SIDED|95.0|0.51|1.22|||Regression, Cox|The Cox regression model = treatment group+ severity of asthma + region as fixed class effects, stratified by randomization stratum|A hazard ratio \< 1 favors the treatment group in the numerator of the ratio.|Hazard Ratio = QAW039 150mg / Placebo||1.22|0.51|
72620685|NCT02336555|144772461|SUPERIORITY||Odds Ratio (OR)|1.073|||||TWO_SIDED|95.0|0.446|2.58|||||Logistic regression model with factors for treatment \& baseline pain intensity|||2.580|0.446|
72622498|NCT00761137|144774977|SUPERIORITY_OR_OTHER|||||||0.6|TWO_SIDED||||||ANOVA|||"Primary outcome was analyzed by a mixed-effects ANOVA model employing subject as a random factor as well as visit and treatment as fixed factors. Intention-to-treat (ITT) sample was analyzed. Unweighted means and their 95% Confidence Interval (CI) are reported, which represent treatment group means adjusted for the effect of visit and removing the intra-subject variability. For all analyses, significance level was set at 5%."||||0.6
72622499|NCT04548219|144774979|OTHER|A linear fixed-effects model is used to estimate the relative bioavailability.|Ratio of Geometric least squares mean|0.907|||||TWO_SIDED|90.0|0.775|1.06||||||||1.06|0.775|
72622500|NCT04548219|144774980|OTHER|A linear fixed-effects model is used to estimate the relative bioavailability.|Ratio of Geometric least squares mean|0.915|||||TWO_SIDED|90.0|0.761|1.1||||||||1.10|0.761|
72456050|NCT03052517|144435385|OTHER||Hazard Ratio (HR)|0.61|||||TWO_SIDED|95.0|0.39|0.97|||Regression, Cox|The Cox regression model = treatment group+ severity of asthma + region as fixed class effects, stratified by randomization stratum|A hazard ratio \< 1 favors the treatment group in the numerator of the ratio.|Hazard Ratio = QAW039 450mg / Placebo||0.97|0.39|
72456051|NCT03052517|144435385|OTHER||Hazard Ratio (HR)|0.78|||||TWO_SIDED|95.0|0.54|1.14|||Regression, Cox|The Cox regression model = treatment group+ severity of asthma + region as fixed class effects, stratified by randomization stratum|A hazard ratio \< 1 favors the treatment group in the numerator of the ratio.|Hazard Ratio = QAW039 450mg / QAW039 150mg||1.14|0.54|
72456052|NCT03052517|144435386|OTHER||Hazard Ratio (HR)|0.8|||||TWO_SIDED|95.0|0.54|1.22|||Regression, Cox|The Cox regression model = treatment group+ severity of asthma + region as fixed class effects, stratified by randomization stratum|A hazard ratio \< 1 favors the treatment group in the numerator of the ratio.|Hazard Ratio = QAW039 150mg / Placebo||1.22|0.54|
72456053|NCT03052517|144435386|OTHER||Hazard Ratio (HR)|0.63|||||TWO_SIDED|95.0|0.41|0.97|||Regression, Cox|The Cox regression model = treatment group+ severity of asthma + region as fixed class effects, stratified by randomization stratum|A hazard ratio \< 1 favors the treatment group in the numerator of the ratio.|Hazard Ratio = QAW039 450mg / Placebo||0.97|0.41|
72456054|NCT03052517|144435386|OTHER||Hazard Ratio (HR)|0.78|||||TWO_SIDED|95.0|0.55|1.11|||Regression, Cox|The Cox regression model = treatment group+ severity of asthma + region as fixed class effects, stratified by randomization stratum|A hazard ratio \< 1 favors the treatment group in the numerator of the ratio.|Hazard Ratio = QAW039 450mg / QAW039 150mg||1.11|0.55|
72456055|NCT03052517|144435387|OTHER||Hazard Ratio (HR)|0.98|||||TWO_SIDED|95.0|0.47|2.23|||Regression, Cox|The Cox regression model = treatment group+ severity of asthma + region as fixed class effects, stratified by randomization stratum|A hazard ratio \< 1 favors the treatment group in the numerator of the ratio.|Hazard Ratio = QAW039 150mg / Placebo||2.23|0.47|
72456056|NCT03052517|144435387|OTHER||Hazard Ratio (HR)|1.18|||||TWO_SIDED|95.0|0.59|2.64|||Regression, Cox|The Cox regression model = treatment group+ severity of asthma + region as fixed class effects, stratified by randomization stratum|A hazard ratio \< 1 favors the treatment group in the numerator of the ratio.|Hazard Ratio = QAW039 450mg / Placebo||2.64|0.59|
72456057|NCT03052517|144435387|OTHER||Hazard Ratio (HR)|1.2|||||TWO_SIDED|95.0|0.7|2.1|||Regression, Cox|The Cox regression model = treatment group+ severity of asthma + region as fixed class effects, stratified by randomization stratum|A hazard ratio \< 1 favors the treatment group in the numerator of the ratio.|Hazard Ratio = QAW039 450mg / QAW039 150mg||2.10|0.70|
72456058|NCT03052517|144435388|OTHER||Hazard Ratio (HR)|1.14|||||TWO_SIDED|95.0|0.56|2.56|||Regression, Cox|The Cox regression model = treatment group+ severity of asthma + region as fixed class effects, stratified by randomization stratum|A hazard ratio \< 1 favors the treatment group in the numerator of the ratio.|Hazard Ratio = QAW039 150mg / Placebo||2.56|0.56|
72456059|NCT03052517|144435388|OTHER||Hazard Ratio (HR)|1.33|||||TWO_SIDED|95.0|0.67|2.95|||Regression, Cox|The Cox regression model = treatment group+ severity of asthma + region as fixed class effects, stratified by randomization stratum|A hazard ratio \< 1 favors the treatment group in the numerator of the ratio.|Hazard Ratio = QAW039 450mg / Placebo||2.95|0.67|
72456060|NCT03052517|144435388|OTHER||Hazard Ratio (HR)|1.17|||||TWO_SIDED|95.0|0.7|1.96|||Regression, Cox|The Cox regression model = treatment group+ severity of asthma + region as fixed class effects, stratified by randomization stratum|A hazard ratio \< 1 favors the treatment group in the numerator of the ratio.|Hazard Ratio = QAW039 450mg / QAW039 150mg||1.96|0.70|
72456061|NCT03052517|144435389|SUPERIORITY||Odds Ratio (OR)|0.81|||||TWO_SIDED|95.0|0.626|1.047|||Regression, Logistic|Logistic regression model: logit (proportion) = randomization stratum, treatment, severity of asthma, region as fixed effects||Statistical Analysis for Number of patients with at least one AE. Hazard Ratio = QAW039 150mg /Placebo||1.047|0.626|
72456062|NCT03052517|144435389|SUPERIORITY||Odds Ratio (OR)|0.8|||||TWO_SIDED|95.0|0.622|1.038|||Regression, Logistic|Logistic regression model: logit (proportion) = randomization stratum, treatment, severity of asthma, region as fixed effects||Statistical Analysis for Number of patients with at least one AE. Hazard Ratio = QAW039 450mg /Placebo||1.038|0.622|
72456063|NCT03052517|144435389|SUPERIORITY||Odds Ratio (OR)|0.99|||||TWO_SIDED|95.0|0.821|1.2|||Regression, Logistic|Logistic regression model: logit (proportion) = randomization stratum, treatment, severity of asthma, region as fixed effects||Statistical Analysis for Number of patients with at least one AE. Hazard Ratio = QAW039 450mg /QAW039 150mg||1.200|0.821|
72456064|NCT03052517|144435390|SUPERIORITY||Odds Ratio (OR)|0.87|||||TWO_SIDED|95.0|0.667|1.125|||Regression, Logistic|Logistic regression model: logit (proportion) = randomization stratum, treatment, severity of asthma, region as fixed effects||Statistical Analysis for Number of patients with at least one AE. Hazard Ratio = QAW039 150mg /Placebo||1.125|0.667|
72622501|NCT04548219|144774981|OTHER|A linear fixed-effects model is used to estimate the relative bioavailability.|Ratio of Geometric least squares mean|0.915|||||TWO_SIDED|90.0|0.76|1.1||||||||1.10|0.760|
72456065|NCT03052517|144435390|SUPERIORITY||Odds Ratio (OR)|0.83|||||TWO_SIDED|95.0|0.643|1.082|||Regression, Logistic|Logistic regression model: logit (proportion) = randomization stratum, treatment, severity of asthma, region as fixed effects||Statistical Analysis for Number of patients with at least one AE. Hazard Ratio = QAW039 450mg /Placebo||1.082|0.643|
72456066|NCT03052517|144435390|SUPERIORITY||Odds Ratio (OR)|0.96|||||TWO_SIDED|95.0|0.794|1.167|||Regression, Logistic|Logistic regression model: logit (proportion) = randomization stratum, treatment, severity of asthma, region as fixed effects||Statistical Analysis for Number of patients with at least one AE. Hazard Ratio = QAW039 450mg /QAW039 150mg||1.167|0.794|
72456067|NCT00849485|144435492|NON_INFERIORITY_OR_EQUIVALENCE|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Geometric Test/Ref Ratio x 100|98.0||||||90.0|94.5|102.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||102|94.5|
72456068|NCT00849485|144435493|NON_INFERIORITY_OR_EQUIVALENCE|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Geometric Test/Ref Ratio x 100|99.9||||||90.0|97.6|102.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||102|97.6|
72622502|NCT02613507|144774988|SUPERIORITY|||||||0.0006|TWO_SIDED|||||The boundary for statistical significance requires the p-value to be less than 0.0231|Stratified weighted Log-Rank|Stratified weighted using G \[rho=0, gamma=1\] Fleming and Harrington.||||||0.0006
72622503|NCT02613507|144774988|SUPERIORITY||Hazard Ratio (HR)|0.68|||||TWO_SIDED|97.7|0.52|0.9|||Stratified Cox Proportional Hazard Model|||||0.90|0.52|
72456069|NCT00849485|144435494|NON_INFERIORITY_OR_EQUIVALENCE|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Geometric Test/Ref Ratio x 100|101.0||||||90.0|98.1|104.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||104|98.1|
72456070|NCT00186446|144435495|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|t(19)= -8.93||||||<.001
72456071|NCT02833948|144435503|SUPERIORITY|||||||0.01|||||||Fisher Exact|The Fisher's exact probability test was used to compare the percentages of patients with the primary end point between the treatment groups.||||||0.01
72456072|NCT02833948|144435507|SUPERIORITY|||||||0.01|||||||Fisher Exact|||||||0.01
72456073|NCT02852824|144435515|OTHER||Slope|0.9058|STANDARD_ERROR_OF_MEAN|0.0523|||TWO_SIDED|95.0|0.7973|1.0142||||||Dose proportionality was explored using a regression model. A 95% confidence interval (CI) for the slope was computed. Power model is used a statistical method.||1.0142|0.7973|
72456074|NCT02852824|144435516|OTHER||Slope|0.9528|STANDARD_ERROR_OF_MEAN|0.0454|||TWO_SIDED|95.0|0.8581|1.0475||||||Dose proportionality was explored using a regression model. A 95% confidence interval (CI) for the slope was computed. Power model is used as statistical method.||1.0475|0.8581|
72456075|NCT02852824|144435517|OTHER||Slope|0.9439|STANDARD_ERROR_OF_MEAN|0.0358|||TWO_SIDED|95.0|0.8697|1.0182||||||Dose proportionality was explored using a regression model. A 95% confidence interval (CI) for the slope was computed. Power model is used as statistical method.||1.0182|0.8697|
72456076|NCT02852824|144435518|OTHER||Slope|0.9708|STANDARD_ERROR_OF_MEAN|0.0351|||TWO_SIDED|95.0|0.8975|1.044||||||Dose proportionality was explored using a regression model. A 95% confidence interval (CI) for the slope was computed. Power model is used as statistical method.||1.0440|0.8975|
72456077|NCT03787628|144435523|OTHER|Generalized linear mixed model (GLMM) testing the main effect of group and time, and the group X time interaction.|F-test|0.703||||0.41|TWO_SIDED|||||P-value reflects the test of the interaction between group and time on the measure of cue-induced craving.|Mixed Models Analysis||Estimated value reflects the f test of the interaction between group and time on the measure of cue-induced craving (degrees of freedom = 1, 67).|||||0.41
72620686|NCT00993473|144772462|NON_INFERIORITY_OR_EQUIVALENCE|"Noninferiority would be demonstrated if the upper bound of the 95% confidence interval (CI) for the ratio of the rate of all hypoglycemia in the Lantus group to the rate in the NPH group was \<1.15. Superiority would be demonstrated if the upper bound of the 95% CI was \<1. The margin for noninferiority corresponded to one-half of the 30% difference in hypoglycemia event rate considered as a clinically significant difference by American Diabetes Association 2005 Working Group on Hypoglycemia."|Risk Ratio (RR)|1.18|STANDARD_ERROR_OF_MEAN|0.12|||TWO_SIDED|95.0|0.97|1.44|||Generalized Linear Model|"A stepwise closed testing approach was used for the primary all hypoglycemia outcome analysis to assess noninferiority and superiority sequentially."|Risk ratio between treatment groups (Lantus/NPH) estimated by Generalized Linear Model with fixed effect terms for randomization strata and treatment.|"The sample size was calculated to ensure sufficient power so that the upper bound of the 2-sided 95% CI for the Lantus /NPH ratio would not exceed 1.15 based on an expected overall rate of all hypoglycemia of 80 events per patient-year of exposure to NPH insulin and to Lantus. It was planned to randomize at least 45 and up to approximately 60 patients in each of the 2 treatment groups so that at least 70 patients would complete the 24 weeks of treatment."||1.44|0.97|
72456078|NCT03787628|144435524|OTHER|Generalized linear mixed model (GLMM) testing the main effect of group and time, and the group X time interaction.|F-test|0.0||||0.99|TWO_SIDED|||||P-value reflects the test of the interaction between group and time on the measure of spontaneous craving.|Mixed Models Analysis||Estimated value reflects the f test of the interaction between group and time on spontaneous craving (degrees of freedom = 1, 550).|||||0.99
72456079|NCT03787628|144435525|OTHER|Generalized linear mixed model (GLMM) testing the main effect of group and time, and the group X time interaction.|F-test|0.04||||0.84|TWO_SIDED|||||P-value reflects the test of the interaction between group and time on the measure of state anxiety.|Mixed Models Analysis||Estimated value reflects the f test of the interaction between group and time on state anxiety (degrees of freedom = 1, 550)|||||0.84
72456080|NCT03787628|144435526|OTHER|Generalized linear mixed model (GLMM) testing the main effect of group and time, and the group X time interaction.|F-test|0.27||||0.6|TWO_SIDED|||||P-value reflects the test of the interaction between group and time on the measure of negative affect.|Mixed Models Analysis||Estimated value reflects the f test of the interaction between group and time on negative affect (degrees of freedom = 1, 550).|||||0.60
72620687|NCT01633112|144772482|SUPERIORITY|For each of the 2 FTY720 doses, the null hypothesis was that there was no difference in the ARRs between subjects treated with FTY720 and those treated with GA versus the alternative hypothesis that there was a difference between the 2 treatment arms. In order to preserve the Type I experiment-wise error rate, the null hypothesis was rejected if the observed p-value for the between-treatment comparison was less than the significance level as specified in the multiplicity adjustment procedure.||||||0.0138|||||||negative binomial regression model|adjusted for treatment, geographical region, number of relapses in the previous year, baseline EDSS, and baseline Gd-enhancing T1 lesion count.||H01: µ FTY 0.5 mg = µ GA versus HA1: µ FTY 0.5 mg ≠µ GA H02: µ FTY 0.25 mg = µ GA versus HA2: µ FTY 0.25 mg ≠µ GA||||0.0138
72620688|NCT01633112|144772482|SUPERIORITY|For each of the 2 FTY720 doses, the null hypothesis was that there was no difference in the ARRs between subjects treated with FTY720 and those treated with GA versus the alternative hypothesis that there was a difference between the 2 treatment arms. In order to preserve the Type I experiment-wise error rate, the null hypothesis was rejected if the observed p-value for the between-treatment comparison was less than the significance level as specified in the multiplicity adjustment procedure.||||||0.4153|||||||negative binomial regression model|adjusted for treatment, geographical region, number of relapses in the previous year, baseline EDSS, and baseline Gd-enhancing T1 lesion count.||H01: µ FTY 0.5 mg = µ GA versus HA1: µ FTY 0.5 mg ≠µ GA H02: µ FTY 0.25 mg = µ GA versus HA2: µ FTY 0.25 mg ≠µ GA||||0.4153
72620689|NCT01633112|144772483|OTHER||||||<|0.0001|||||||negative binomial regression model|Adjusted for treatment, geog. region, age, baseline T2 lesion count, baseline Gd-enhancing T1 lesion count, and the number of previous year relapses.||||||<0.0001
72622504|NCT02613507|144774988|SUPERIORITY|||||||0.0017|||||||Log Rank|regular stratified log-rank test p-value||||||0.0017
72370435|NCT00488683|144251631|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|-0.05||||0.7||95.0||||Values from Group 1, 2 and 3 were combined for this analysis.|Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccinations and memory B cells at 12 months of age for the serogroup C||||0.70
72370436|NCT00488683|144251631|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.3||||0.04||95.0||||Values from Group 1, 2 and 3 were combined for this analysis.|Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccinations and memory B cells at 12 months of age for the serogroup W-135||||0.04
72370437|NCT00488683|144251631|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.46||||0.004||95.0||||Values from Group 1, 2 and 3 were combined for this analysis.|Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccinations and memory B cells at 12 months of age for the serogroup Y||||0.004
72456081|NCT03960645|144435606|OTHER||GLSM ratio (%)|41.24|||||TWO_SIDED|90.0|36.71|46.32||||||BIC: Second Trimester (Test) vs. Week 12 Post-partum (Reference). A 90% confidence interval (CI) was constructed for the geometric least squares mean (GLSM) ratio (%).||46.32|36.71|
72456082|NCT03960645|144435606|OTHER||GLSM ratio (%)|44.65|||||TWO_SIDED|90.0|40.04|49.79||||||BIC: Second Trimester (Test) vs. Week 6 Post-partum (Reference). A 90% CI was constructed for the GLSM ratio (%).||49.79|40.04|
72456083|NCT03960645|144435606|OTHER||GLSM ratio (%)|40.57|||||TWO_SIDED|90.0|36.77|44.76||||||BIC: Third Trimester (Test) vs. Week 12 Post-partum (Reference). A 90% CI was constructed for the GLSM ratio (%).||44.76|36.77|
72456084|NCT03960645|144435606|OTHER||GLSM ratio (%)|44.4|||||TWO_SIDED|90.0|39.95|49.34||||||BIC: Third Trimester (Test) vs. Week 6 Post-partum (Reference). A 90% CI was constructed for the GLSM ratio (%).||49.34|39.95|
72456085|NCT03960645|144435607|OTHER||GLSM ratio (%)|67.38|||||TWO_SIDED|90.0|63.45|71.56||||||FTC: Second Trimester (Test) vs. Week 12 Post-partum (Reference). A 90% CI was constructed for the GLSM ratio (%).||71.56|63.45|
72456086|NCT03960645|144435607|OTHER||GLSM ratio (%)|64.26|||||TWO_SIDED|90.0|60.95|67.75||||||FTC: Second Trimester (Test) vs. Week 6 Post-partum (Reference). A 90% CI was constructed for the GLSM ratio (%).||67.75|60.95|
72456087|NCT03960645|144435607|OTHER||GLSM ratio (%)|69.19|||||TWO_SIDED|90.0|65.88|72.66||||||FTC: Third Trimester (Test) vs. Week 12 Post-partum (Reference). A 90% CI was constructed for the GLSM ratio (%).||72.66|65.88|
72456088|NCT03960645|144435607|OTHER||GLSM ratio (%)|65.09|||||TWO_SIDED|90.0|61.79|68.57||||||FTC: Third Trimester (Test) vs. Week 6 Post-partum (Reference). A 90% CI was constructed for the GLSM ratio (%).||68.57|61.79|
72456089|NCT03960645|144435607|OTHER||GLSM ratio (%)|77.62|||||TWO_SIDED|90.0|65.4|92.14||||||TAF: Second Trimester (Test) vs. Week 12 Post-partum (Reference). A 90% CI was constructed for the GLSM ratio (%).||92.14|65.40|
72456090|NCT03960645|144435607|OTHER||GLSM ratio (%)|62.5|||||TWO_SIDED|90.0|50.76|76.96||||||TAF: Second Trimester (Test) vs. Week 6 Post-partum (Reference). A 90% CI was constructed for the GLSM ratio (%).||76.96|50.76|
72456091|NCT03960645|144435607|OTHER||GLSM ratio (%)|69.67|||||TWO_SIDED|90.0|58.57|82.88||||||TAF: Third Trimester (Test) vs. Week 12 Post-partum (Reference). A 90% CI was constructed for the GLSM ratio (%).||82.88|58.57|
72456092|NCT03960645|144435607|OTHER||GLSM ratio (%)|56.52|||||TWO_SIDED|90.0|46.32|68.96||||||TAF: Third Trimester (Test) vs. Week 6 Post-partum (Reference). A 90% CI was constructed for the GLSM ratio (%).||68.96|46.32|
72456093|NCT03960645|144435609|OTHER||GLSM ratio (%)|51.91|||||TWO_SIDED|90.0|46.48|57.97||||||BIC: Second Trimester (Test) vs. Week 12 Post-partum (Reference). A 90% CI was constructed for the GLSM ratio (%).||57.97|46.48|
72456094|NCT03960645|144435609|OTHER||GLSM ratio (%)|57.67|||||TWO_SIDED|90.0|52.48|63.36||||||BIC: Second Trimester (Test) vs. Week 6 Post-partum (Reference). A 90% CI was constructed for the GLSM ratio (%).||63.36|52.48|
72456095|NCT03960645|144435609|OTHER||GLSM ratio (%)|48.18|||||TWO_SIDED|90.0|43.03|53.94||||||BIC: Third Trimester (Test) vs. Week 12 Post-partum (Reference). A 90% CI was constructed for the GLSM ratio (%).||53.94|43.03|
72456096|NCT03960645|144435609|OTHER||GLSM ratio (%)|54.42|||||TWO_SIDED|90.0|48.39|61.21||||||BIC: Third Trimester (Test) vs. Week 6 Post-partum (Reference). A 90% CI was constructed for the GLSM ratio (%).||61.21|48.39|
72456097|NCT03960645|144435609|OTHER||GLSM ratio (%)|75.61|||||TWO_SIDED|90.0|66.7|85.7||||||FTC: Second Trimester (Test) vs. Week 12 Post-partum (Reference). A 90% CI was constructed for the GLSM ratio (%).||85.70|66.70|
72456098|NCT03960645|144435609|OTHER||GLSM ratio (%)|77.81|||||TWO_SIDED|90.0|68.76|88.05||||||FTC: Second Trimester (Test) vs. Week 6 Post-partum (Reference). A 90% CI was constructed for the GLSM ratio (%).||88.05|68.76|
72456099|NCT03960645|144435609|OTHER||GLSM ratio (%)|77.45|||||TWO_SIDED|90.0|70.33|85.29||||||FTC: Third Trimester (Test) vs. Week 12 Post-partum (Reference). A 90% CI was constructed for the GLSM ratio (%).||85.29|70.33|
72456100|NCT03960645|144435609|OTHER||GLSM ratio (%)|77.08|||||TWO_SIDED|90.0|69.78|85.15||||||FTC: Third Trimester (Test) vs. Week 6 Post-partum (Reference). A 90% CI was constructed for the GLSM ratio (%).||85.15|69.78|
72456101|NCT03960645|144435609|OTHER||GLSM ratio (%)|69.9|||||TWO_SIDED|90.0|56.16|87.0||||||TAF: Second Trimester (Test) vs. Week 12 Post-partum (Reference). A 90% CI was constructed for the GLSM ratio (%).||87.00|56.16|
72456102|NCT03960645|144435609|OTHER||GLSM ratio (%)|66.55|||||TWO_SIDED|90.0|53.79|82.34||||||TAF: Second Trimester (Test) vs. Week 6 Post-partum (Reference). A 90% CI was constructed for the GLSM ratio (%).||82.34|53.79|
72456103|NCT03960645|144435609|OTHER||GLSM ratio (%)|57.14|||||TWO_SIDED|90.0|46.04|70.91||||||TAF: Third Trimester (Test) vs. Week 12 Post-partum (Reference). A 90% CI was constructed for the GLSM ratio (%).||70.91|46.04|
72456104|NCT03960645|144435609|OTHER||GLSM ratio (%)|55.27|||||TWO_SIDED|90.0|44.65|68.42||||||TAF: Third Trimester (Test) vs. Week 6 Post-partum (Reference). A 90% CI was constructed for the GLSM ratio (%).||68.42|44.65|
72456105|NCT03960645|144435610|OTHER||GLSM ratio (%)|26.17|||||TWO_SIDED|90.0|21.45|31.93||||||BIC: Second Trimester (Test) vs. Week 12 Post-partum (Reference). A 90% CI was constructed for the GLSM ratio (%).||31.93|21.45|
72456106|NCT03960645|144435610|OTHER||GLSM ratio (%)|26.99|||||TWO_SIDED|90.0|22.23|32.78||||||BIC: Second Trimester (Test) vs. Week 6 Post-partum (Reference). A 90% CI was constructed for the GLSM ratio (%).||32.78|22.23|
72456107|NCT03960645|144435610|OTHER||GLSM ratio (%)|29.03|||||TWO_SIDED|90.0|25.74|32.74||||||BIC: Third Trimester (Test) vs. Week 12 Post-partum (Reference). A 90% CI was constructed for the GLSM ratio (%).||32.74|25.74|
72456108|NCT03960645|144435610|OTHER||GLSM ratio (%)|29.97|||||TWO_SIDED|90.0|26.47|33.93||||||BIC: Third Trimester (Test) vs. Week 6 Post-partum (Reference). A 90% CI was constructed for the GLSM ratio (%).||33.93|26.47|
72456109|NCT03960645|144435610|OTHER||GLSM ratio (%)|64.22|||||TWO_SIDED|90.0|54.63|75.49||||||FTC: Second Trimester (Test) vs. Week 12 Post-partum (Reference). A 90% CI was constructed for the GLSM ratio (%).||75.49|54.63|
72456110|NCT03960645|144435610|OTHER||GLSM ratio (%)|42.89|||||TWO_SIDED|90.0|36.55|50.34||||||FTC: Second Trimester (Test) vs. Week 6 Post-partum (Reference). A 90% CI was constructed for the GLSM ratio (%).||50.34|36.55|
72456111|NCT03960645|144435610|OTHER||GLSM ratio (%)|64.71|||||TWO_SIDED|90.0|59.3|70.61||||||FTC: Third Trimester (Test) vs. Week 12 Post-partum (Reference). A 90% CI was constructed for the GLSM ratio (%).||70.61|59.30|
72456112|NCT03960645|144435610|OTHER||GLSM ratio (%)|46.92|||||TWO_SIDED|90.0|39.57|55.64||||||FTC: Third Trimester (Test) vs. Week 6 Post-partum (Reference). A 90% CI was constructed for the GLSM ratio (%).||55.64|39.57|
72456113|NCT01450007|144435619|SUPERIORITY_OR_OTHER|||||||0.001|||||||ANOVA|||||||0.001
72456114|NCT01450007|144435620|SUPERIORITY_OR_OTHER|||||||0.001|||||||ANOVA|||||||0.001
72456115|NCT01450007|144435621|SUPERIORITY_OR_OTHER|||||||0.76|||||||ANOVA|||||||0.76
72456116|NCT01450007|144435622|SUPERIORITY_OR_OTHER|||||||0.61|||||||Kruskal-Wallis|||Comparison between the 3 groups for pain scores at 24 hours.||||0.61
72456117|NCT01450007|144435622|SUPERIORITY_OR_OTHER|||||||0.13|||||||Kruskal-Wallis|||Comparison between the 3 groups for pain scores at 48 hours.||||0.13
72456118|NCT01450007|144435622|SUPERIORITY_OR_OTHER|||||||0.25|||||||Kruskal-Wallis|||Comparison between the 3 groups for pain scores at 1 week.||||0.25
72456119|NCT01335061|144435623|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Paired t-test|||||||<0.0001
72456120|NCT01332266|144435640|SUPERIORITY||Hazard Ratio (HR)|0.89|||||TWO_SIDED|95.0|0.54|1.46||||||||1.46|0.54|
72500166|NCT02514044|144530634|OTHER|"We also performed normalization by calculating the dependent variable as the percentage of change (proportional change) as it follows; (1) (post-active values - pre-active values)/ (pre-active values) and (2) (post-placebo values - pre-placebo values)/ (pre-placebo series). We compared the percentage of change in Bedside WAB-R® aphasia and language quotients and blood pressures for the experiments with active- and placebo drugs combined active tDCS with MIT using a two-tailed paired t-test."||||||0.02|TWO_SIDED|95.0|||||t-test, 2 sided|||We tested normality using the Kolmogorov-Smirnov (KS) test for all reported measures. We compared scores of Bedside WAB-R® subtests Bedside WAB-R® AQ and LQ from before the study intervention and after the intervention in both experiments by using a two-tailed and paired t-test.||||0.02
72456121|NCT01332266|144435642|SUPERIORITY||Hazard Ratio (HR)|1.03|||||TWO_SIDED|95.0|0.61|1.73||||||||1.73|0.61|
72456122|NCT01332266|144435643|SUPERIORITY||Hazard Ratio (HR)|0.85|||||TWO_SIDED|95.0|0.53|1.37||||||||1.37|0.53|
72456123|NCT03302091|144435645|OTHER||Adjusted gMean ratio (T/R)%|198.5|STANDARD_DEVIATION|96.5|||TWO_SIDED|90.0|101.83|386.94|||ANOVA||Standard deviation is actually intra individual geometric coefficient of variation (%).|"The statistical model used for the analyses of the primary endpoints was an ANOVA (analysis of variance) model on the logarithmic scale including the effect degree of renal impairment as a fixed effect as well as subject pair as a random effect."||386.94|101.83|
72456124|NCT03302091|144435646|OTHER||Adjusted gMean ratio (T/R)%|198.42|STANDARD_DEVIATION|77.5|||TWO_SIDED|90.0|116.56|337.78|||ANOVA||Standard deviation is actually intra individual geometric coefficient of variation (%).|"The statistical model used for the analyses of the primary endpoints was an ANOVA (analysis of variance) model on the logarithmic scale including the effect degree of renal impairment as a fixed effect as well as subject pair as a random effect."||337.78|116.56|
72456125|NCT03302091|144435647|OTHER||Adjusted gMean ratio (T/R)%|226.29|STANDARD_DEVIATION|47.5|||TWO_SIDED|90.0|156.35|327.53|||ANOVA||Standard deviation is actually intra individual geometric coefficient of variation (%).|"The statistical model used for the analyses of the primary endpoints was an ANOVA (analysis of variance) model on the logarithmic scale including the effect degree of renal impairment as a fixed effect as well as subject pair as a random effect."||327.53|156.35|
72456126|NCT03302091|144435648|OTHER||Adjusted gMean ratio (T/R)%|140.4|STANDARD_DEVIATION|32.8|||TWO_SIDED|90.0|108.06|182.43|||ANOVA||Standard deviation is actually intra individual geometric coefficient of variation (%).|"The statistical model used for the analyses of the primary endpoints was an ANOVA (analysis of variance) model on the logarithmic scale including the effect degree of renal impairment as a fixed effect as well as subject pair as a random effect."||182.43|108.06|
72456127|NCT03302091|144435649|OTHER||Adjusted gMean ratio (T/R)%|165.63|STANDARD_DEVIATION|56.6|||TWO_SIDED|90.0|107.51|255.17|||ANOVA||Standard deviation is actually intra individual geometric coefficient of variation (%).|"The statistical model used for the analyses of the primary endpoints was an ANOVA (analysis of variance) model on the logarithmic scale including the effect degree of renal impairment as a fixed effect as well as subject pair as a random effect."||255.17|107.51|
72456128|NCT03302091|144435650|OTHER||Adjusted gMean ratio (T/R)%|128.44|STANDARD_DEVIATION|31.7|||TWO_SIDED|90.0|99.64|165.57|||ANOVA||Standard deviation is actually intra individual geometric coefficient of variation (%).|"The statistical model used for the analyses of the primary endpoints was an ANOVA (analysis of variance) model on the logarithmic scale including the effect degree of renal impairment as a fixed effect as well as subject pair as a random effect."||165.57|99.64|
72456129|NCT01536704|144435651|NON_INFERIORITY_OR_EQUIVALENCE|Bio-equivalence between two dosage treatments was concluded if the 90% confidence interval for the ratio of the means for AUC (0-t) lies within the interval 0.80 to 1.25.|Geometric Mean Ratio|0.91|||||TWO_SIDED|90.0|0.88|0.94|||Wilcoxon Signed Rank Test||Geometric mean ratio of Cherry and Mint lozenge was determined by exponentiating least-squares means of log-transformed value.|The value was log-transformed and a linear mixed effects model was applied to this value, as the dependent variable, treatment, and period as fixed effects and participants as random effect.||0.94|0.88|
72456130|NCT01536704|144435651|NON_INFERIORITY_OR_EQUIVALENCE|Bio-equivalence between two dosage treatments was concluded if the 90% confidence interval for the ratio of the means for AUC (0-t) lies within the interval 0.80 to 1.25.|Geometric Mean Ratio|1.02|||||TWO_SIDED|90.0|0.98|1.05|||Wilcoxon Signed Rank test||Geometric mean ratio of Cherry and Mint lozenge was determined by exponentiating least-squares means of log-transformed value.|The value was log-transformed and a linear mixed effects model was applied to this value, as the dependent variable, treatment, and period as fixed effects and participants as random effect.||1.05|0.98|
72456131|NCT01536704|144435652|NON_INFERIORITY_OR_EQUIVALENCE|Bio-equivalence between two dosage treatments was concluded if the 90% confidence interval for the ratio of the means for Cmax lies within the interval 0.80 to 1.25.|Geometric Mean Ratio|0.89|||||TWO_SIDED|90.0|0.85|0.94|||Wilcoxon Signed Rank Test||Geometric mean ratio of Cherry and Mint lozenge was determined by exponentiating least-squares means of log-transformed value.|The value was log-transformed and a linear mixed effects model was applied to this value, as the dependent variable, treatment, and period as fixed effects and participants as random effect.||0.94|0.85|
72500167|NCT01834404|144530710|SUPERIORITY_OR_OTHER|||||||0.057|TWO_SIDED||||||ANCOVA|||||||0.057
72500168|NCT01834404|144530711|SUPERIORITY_OR_OTHER|||||||0.052|TWO_SIDED||||||ANCOVA|||||||0.052
72456132|NCT01536704|144435652|NON_INFERIORITY_OR_EQUIVALENCE|Bio-equivalence between two dosage treatments was concluded if the 90% confidence interval for the ratio of the means for Cmax lies within the interval 0.80 to 1.25.|Geometric Mean Ratio|0.97|||||TWO_SIDED|90.0|0.93|1.02|||Wilcoxon Signed Rank Test||Geometric mean ratio of Cherry and Mint lozenge was determined by exponentiating least-squares means of log-transformed value.|The value was log-transformed and a linear mixed effects model was applied to this value, as the dependent variable, treatment, and period as fixed effects and participants as random effect.||1.02|0.93|
72456133|NCT01536704|144435653|NON_INFERIORITY_OR_EQUIVALENCE|Bio-equivalence between two dosage treatments was concluded if the 90% confidence interval for the ratio of the means for AUC (0-inf) lies within the interval 0.80 to 1.25.|Geometric Mean Ratio|0.92||||||90.0|0.88|0.95|||Wilcoxon Signed Rank Test||Geometric mean ratio of Cherry and Mint lozenge was determined by exponentiating least-squares means of log-transformed value.|The value was log-transformed and a linear mixed effects model was applied to this value, as the dependent variable, treatment, and period as fixed effects and participants as random effect.||0.95|0.88|
72456134|NCT01536704|144435653|NON_INFERIORITY_OR_EQUIVALENCE|Bio-equivalence between two dosage treatments was concluded if the 90% confidence interval for the ratio of the means for AUC (0-inf) lies within the interval 0.80 to 1.25.|Geometric Mean Ratio|1.02|||||TWO_SIDED|90.0|0.98|1.06|||Wilcoxon Signed Rank Test||Geometric mean ratio of Cherry and Mint lozenge was determined by exponentiating least-squares means of log-transformed value.|The value was log-transformed and a linear mixed effects model was applied to this value, as the dependent variable, treatment, and period as fixed effects and participants as random effect.||1.06|0.98|
72369034|NCT01499277|144248034|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the observed difference in the primary outcome measures (clinical cure rates) between ceftaroline group and vancomycin plus aztreonam group were calculated in both MITT and CE Populations at the TOC visit. Noninferiority was concluded if the lower limit of the 95% CI was higher than -10% in both MITT and CE Populations.|Risk Difference (RD)|-0.95|||||TWO_SIDED|95.0|-6.9|5.41||||RD is the difference in clinical cure rates (Ceftaroline minus Vancomycin/Aztreonam). CI was calculated by unstratified Miettinen and Nurminen CI.|CI for risk difference was estimated by 95% using unstratified Miettinen and Nurminen CI.|The primary objective of this study was to determine the noninferiority in the clinical cure rate for ceftaroline compared vancomycin plus azreonam group at TOC in both MITT and CE populations.||5.41|-6.9|
72456135|NCT01536704|144435654|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0006||||0.1491||95.0|||||Wilcoxon Signed Rank Test|The value of Tmax was adjusted for this non-parametric analysis.|The median difference was calculated as Cherry minus Peppermint.|The null hypothesis considered that there is no median within-subject difference between two treatment groups.||||0.1491
72456136|NCT01536704|144435654|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0005||||0.679||95.0|||||Wilcoxon Signed Rank Test|The value of Tmax was adjusted for this non-parametric analysis.|The median difference was calculated as Cherry minus Peppermint.|The null hypothesis considered that there is no median within-subject difference between two treatment groups.||||0.6790
72456137|NCT01536704|144435655|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.0641||||0.5619||95.0|||||Wilcoxon Signed Rank Test|The value of T (1/2) was adjusted for this non-parametric analysis.|The median difference was calculated as Cherry minus Peppermint.|The null hypothesis considered that there is no median within-subject difference between two treatment groups.||||0.5619
72456138|NCT01536704|144435655|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0538||||0.4523||95.0|||||Wilcoxon Signed Rank Test|The value of T (1/2) was adjusted for this non-parametric analysis.|The median difference was calculated as Cherry minus Peppermint.|The null hypothesis considered that there is no median within-subject difference between two treatment groups.||||0.4523
72456139|NCT01536704|144435656|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0025||||0.5113||95.0|||||Wilcoxon Signed Rank Test|This non-parametric analysis was performed on the unadjusted values of parameters.|The median difference was calculated as Cherry minus Peppermint.|The null hypothesis considered that there is no median within-subject difference between two treatment groups.||||0.5113
72456140|NCT01536704|144435656|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.0042||||0.537||95.0|||||Wilcoxon Signed Rank Test|This non-parametric analysis was performed on the unadjusted values of parameters.|The median difference was calculated as Cherry minus Peppermint.|The null hypothesis considered that there is no median within-subject difference between two treatment groups.||||0.5370
72456141|NCT01482091|144435805|SUPERIORITY_OR_OTHER|||||||0.048|||||||Wilcoxon (Mann-Whitney)|||||||0.048
72456142|NCT01482091|144435807|SUPERIORITY_OR_OTHER||||||=|0.05|||||||Fisher Exact|||||||=0.05
72456143|NCT01482091|144435808|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Chi-squared|||||||>0.05
72456144|NCT01482091|144435811|SUPERIORITY_OR_OTHER||||||=|0.68|||||||t-test, 2 sided|||||||=0.68
72456145|NCT01482091|144435812|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||||||>0.05
72456146|NCT01482091|144435813|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||||||>0.05
72456147|NCT01482091|144435817|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Fisher Exact|||||||>0.05
72456148|NCT01480258|144435818|OTHER|The immune response to PR5I vaccine was considered as acceptable if the lower bounds of the 2-sided 95% CI for the response rates were greater than 75%.|||||<|0.001||||||One-sided p-value|Clopper and Pearson|||Anti-PRP ≥ 1.0 μg/mL||||<0.001
72456149|NCT01480258|144435818|OTHER|The immune response to PR5I vaccine was considered as acceptable if the lower bounds of the 2-sided 95% CI for the response rates were greater than 75%.|||||<|0.001||||||One-sided p-value|Clopper and Pearson|||Anti-HBsAg ≥10 mIU/mL||||<0.001
72456150|NCT01480258|144435818|OTHER|The immune response to PR5I vaccine was considered as acceptable if the lower bounds of the 2-sided 95% CI for the response rates were greater than 75%.|||||<|0.001||||||One-sided p-value|Clopper and Pearson|||Anti-Diphtheria ≥0.1 IU/mL||||<0.001
72456151|NCT01480258|144435818|OTHER|The immune response to PR5I vaccine was considered as acceptable if the lower bounds of the 2-sided 95% CI for the response rates were greater than 75%.|||||<|0.001||||||One-sided p-value|Clopper and Pearson|||Anti-Tetanus ≥0.1 IU/mL||||<0.001
72456152|NCT01480258|144435818|OTHER|The immune response to PR5I vaccine was considered as acceptable if the lower bounds of the 2-sided 95% CI for the response rates were greater than 75%.|||||<|0.001||||||One-sided p-value|Clopper and Pearson|||Anti-PT seroresponse||||<0.001
72456153|NCT01480258|144435818|OTHER|The immune response to PR5I vaccine was considered as acceptable if the lower bounds of the 2-sided 95% CI for the response rates were greater than 75%.|||||<|0.001||||||One-sided p-value|Clopper and Pearson|||Anti-FHA seroresponse||||<0.001
72456154|NCT01480258|144435818|OTHER|The immune response to PR5I vaccine was considered as acceptable if the lower bounds of the 2-sided 95% CI for the response rates were greater than 75%.|||||<|0.001||||||One-sided p-value|Clopper and Pearson|||Anti-FIM seroresponse||||<0.001
72456155|NCT01480258|144435818|OTHER|The immune response to PR5I vaccine was considered as acceptable if the lower bounds of the 2-sided 95% CI for the response rates were greater than 75%.|||||<|0.001||||||One-sided p-value|Clopper and Pearson|||Anti-PRN seroresponse||||<0.001
72456156|NCT01480258|144435818|OTHER|The immune response to PR5I vaccine was considered as acceptable if the lower bounds of the 2-sided 95% CI for the response rates were greater than 75%.|||||<|0.001||||||One-sided p-value|Clopper and Pearson|||Anti-IPV1 ≥1:8 dilution||||<0.001
72456157|NCT01480258|144435818|OTHER|The immune response to PR5I vaccine was considered as acceptable if the lower bounds of the 2-sided 95% CI for the response rates were greater than 75%.|||||<|0.001||||||One-sided p-value|Clopper and Pearson|||Anti-IPV2 ≥1:8 dilution||||<0.001
72456158|NCT01480258|144435818|OTHER|The immune response to PR5I vaccine was considered as acceptable if the lower bounds of the 2-sided 95% CI for the response rates were greater than 75%.|||||<|0.001||||||One-sided p-value|Clopper and Pearson|||Anti-IPV3 ≥1:8 dilution||||<0.001
72456159|NCT01480258|144435819|NON_INFERIORITY|If the lower bound of the 95% confidence interval (CI) was greater than -10% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate.|Difference in percentages|46.2|||<|0.001|TWO_SIDED|95.0|41.05|51.06||Stratification by country.|Miettinen & Nurminen|||||51.06|41.05|<0.001
72456160|NCT01480258|144435820|SUPERIORITY|If the lower bound of the 95% CI was greater than 0, it was concluded that PR5I group response rate was superior to INFANRIX hexa group response rate.|Difference in percentages|46.2|||<|0.001|TWO_SIDED|95.0|41.05|51.06|||Miettinen & Nurminen|Stratification by country.||||51.06|41.05|<0.001
72456161|NCT01480258|144435821|NON_INFERIORITY|The estimate of the difference between PR5I \& INFANRIX hexa groups in PRP response rate (based on Ab titre ≥1.0 μg/mL) was calculated with its 1-sided P-value \& 2-sided 95% CI. If the lower bound of the 95% CI was greater than -10% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate.|Difference in percentages|-1.27|||<|0.001|TWO_SIDED|95.0|-5.13|2.52|||Miettinen & Nurminen with stratification|Statistical analysis was based on the Miettinen \& Nurminen method stratified by country.||Non-inferiority for PRP||2.52|-5.13|<0.001
72456162|NCT01480258|144435821|NON_INFERIORITY|The estimate of the difference between PR5I \& INFANRIX hexa groups in HBsAg response rate (based on Ab titre ≥10 mIU/mL) was calculated with its 1-sided P-value \& 2-sided 95% CI. If the lower bound of the 95% CI was greater than -10% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate.|ifference in percentages|-0.59|||<|0.001|TWO_SIDED|95.0|-2.66|1.35|||Miettinen & Nurminen with stratification|Statistical analysis was based on the Miettinen \& Nurminen method stratified by country.||Non-Inferiority for HBsAg||1.35|-2.66|<0.001
72456163|NCT01480258|144435821|NON_INFERIORITY|The estimate of the difference between PR5I \& INFANRIX hexa groups in Diphtheria response rate (based on Ab titre ≥0.1 IU/mL) was calculated with its 1-sided P-value \& 2-sided 95% CI. If the lower bound of the 95% CI was greater than -10% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate.|Difference in percentages|-1.21|||<|0.001|TWO_SIDED|95.0|-2.54|-0.22|||Miettinen & Nurminen with stratification|Statistical analysis was based on the Miettinen \& Nurminen method stratified by country.||Non-Inferiority for Diptheria||-0.22|-2.54|<0.001
72456164|NCT01480258|144435821|NON_INFERIORITY|The estimate of the difference between PR5I \& INFANRIX hexa groups in Tetanus response rate (based on Ab titre ≥0.1 IU/mL) was calculated with its 1-sided P-value \& 2-sided 95% CI. If the lower bound of the 95% CI was greater than -5% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate.|Difference in percentages|-0.17|||<|0.001|TWO_SIDED|95.0|-0.95|0.5|||Miettinen & Nurminen with stratification|Statistical analysis was based on the Miettinen \& Nurminen method stratified by country.||Non-Inferiority for Tetanus||0.50|-0.95|<0.001
72456165|NCT01480258|144435821|NON_INFERIORITY|The estimate of the difference between PR5I \& INFANRIX hexa groups in the percentage of seroresponder participants for PT was calculated with its 1-sided P-value \& 2-sided 95% CI. If the lower bound of the 95% CI was greater than -10% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate.|Difference in percentages|-0.54|||<|0.001|TWO_SIDED|95.0|-1.75|0.49|||Miettinen & Nurminen with stratification|Statistical analysis was based on the Miettinen \& Nurminen method stratified by country.||Non-Inferiority for PT||0.49|-1.75|<0.001
72456166|NCT01480258|144435821|NON_INFERIORITY|The estimate of the difference between PR5I \& INFANRIX hexa groups in the percentage of seroresponder participants for FHA was calculated with its 1-sided P-value \& 2-sided 95% CI. If the lower bound of the 95% CI was greater than -10% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate.|Difference in percentages|-1.73|||<|0.001|TWO_SIDED|95.0|-3.47|-0.26|||Miettinen & Nurminen with stratification|Statistical analysis was based on the Miettinen \& Nurminen method stratified by country.||Non-Inferiority for FHA||-0.26|-3.47|<0.001
72456167|NCT01480258|144435821|NON_INFERIORITY|The estimate of the difference between PR5I \& INFANRIX hexa groups in the percentage of seroresponder participants for PRN was calculated with its 1-sided P-value \& 2-sided 95% CI. If the lower bound of the 95% CI was greater than -10% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate.|Difference in percentages|-1.42|||<|0.001|TWO_SIDED|95.0|-3.42|0.39|||Miettinen & Nurminen with stratification|Statistical analysis was based on the Miettinen \& Nurminen method stratified by country.||Non-Inferiority for PRN||0.39|-3.42|<0.001
72456168|NCT01480258|144435821|NON_INFERIORITY|The estimate of the difference between PR5I \& INFANRIX hexa groups in IPV1 response rate (based on Ab titre ≥8 (1/dil)) was calculated with its 1-sided P-value \& 2-sided 95% CI. If the lower bound of the 95% CI was greater than -5% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate.|Difference in percentages|-0.51|||<|0.001|TWO_SIDED|95.0|-1.59|0.34|||Miettinen & Nurminen with stratification|Statistical analysis was based on the Miettinen \& Nurminen method stratified by country.||Non-Inferiority for IPV1||0.34|-1.59|<0.001
72500169|NCT01834404|144530712|SUPERIORITY_OR_OTHER|||||||0.36|TWO_SIDED||||||ANCOVA|||||||0.36
72500170|NCT01834404|144530713|SUPERIORITY_OR_OTHER|||||||0.99|TWO_SIDED||||||ANCOVA|||||||0.99
72456169|NCT01480258|144435821|NON_INFERIORITY|The estimate of the difference between PR5I \& INFANRIX hexa groups in IPV2 response rate (based on Ab titre ≥8 (1/dil)) was calculated with its 1-sided P-value \& 2-sided 95% CI. If the lower bound of the 95% CI was greater than -5% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate.|Difference in percentages|-0.17|||<|0.001|TWO_SIDED|95.0|-0.96|0.49|||Miettinen & Nurminen with stratification|Statistical analysis was based on the Miettinen \& Nurminen method stratified by country.||Non-Inferiority for IPV2||0.49|-0.96|<0.001
72456170|NCT01480258|144435821|NON_INFERIORITY|The estimate of the difference between PR5I \& INFANRIX hexa groups in IPV3 response rate (based on Ab titre ≥8 (1/dil)) was calculated with its 1-sided P-value \& 2-sided 95% CI. If the lower bound of the 95% CI was greater than -5% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate.|Difference in percentages|-0.16|||<|0.001|TWO_SIDED|95.0|-1.2|0.82|||Miettinen & Nurminen with stratification|Statistical analysis was based on the Miettinen \& Nurminen method stratified by country.||Non-Inferiority for IPV3||0.82|-1.20|<0.001
72456171|NCT01480258|144435822|NON_INFERIORITY|The estimate for anti-rotavirus IgA GMT ratio (PR5I group/INFANRIX hexa group) was calculated with its 1-sided P-value and 2-sided 95% CI. If the lower bound of the 95% CI for GMT ratio was greater than 0.50 (non-inferiority margin), it was concluded that the Rotarix antigen response in the PR5I group was not inferior to the Rotarix antigen response in the INFANRIX hexa group.|Geometric Mean Titre (GMT) ratio|0.8||||0.011|TWO_SIDED|95.0|0.54|1.2|||ANCOVA|||||1.20|0.54|0.011
72456172|NCT01480258|144435823|OTHER|The risk differences between groups (PR5I group - INFANRIX hexa group) and their 2-sided 95% CI were calculated for the above criteria based on the unstratified Miettinen \& Nurminen method. The aim of the 95% CI was to investigate an overall trend and not any specific difference. If 0.0 was excluded from the 95% CI, the trend could not be ruled out.|Risk Difference (RD)|0.3|||||TWO_SIDED|95.0|-0.7|1.4||||||ISR or systemic AE||1.4|-0.7|
72500171|NCT01834404|144530714|SUPERIORITY_OR_OTHER|||||||0.45|TWO_SIDED||||||ANCOVA|||||||0.45
72500172|NCT01834404|144530715|SUPERIORITY_OR_OTHER|||||||0.22|TWO_SIDED||||||ANCOVA|||||||0.22
72500173|NCT01834404|144530716|SUPERIORITY_OR_OTHER|||||||0.032|TWO_SIDED||||||ANCOVA|||||||0.032
72500174|NCT01834404|144530717|SUPERIORITY_OR_OTHER|||||||0.03|TWO_SIDED||||||ANCOVA|||This p-value was based on a rank transformation.||||0.030
72500175|NCT01834404|144530718|SUPERIORITY_OR_OTHER|||||||0.35|TWO_SIDED||||||ANCOVA|||||||0.35
72620690|NCT01633112|144772483|OTHER||||||<|0.0001|||||||negative binomial regression model|Adjusted for treatment, geog. region, age, baseline T2 lesion count, baseline Gd-enhancing T1 lesion count, and the number of previous year relapses.||||||<0.0001
72456173|NCT01480258|144435823|OTHER|The risk differences between groups (PR5I group - INFANRIX hexa group) and their 2-sided 95% CI were calculated for the above criteria based on the unstratified Miettinen \& Nurminen method. The aim of the 95% CI was to investigate an overall trend and not any specific difference. If 0.0 was excluded from the 95% CI, the trend could not be ruled out.|Risk Difference (RD)|0.8||||||95.0|-0.3|2.0||||||ISR or V-related systemic AE||2.0|-0.3|
72456174|NCT01480258|144435823|OTHER|The risk differences between groups (PR5I group - INFANRIX hexa group) and their 2-sided 95% CI were calculated for the above criteria based on the unstratified Miettinen \& Nurminen method. The aim of the 95% CI was to investigate an overall trend and not any specific difference. If 0.0 was excluded from the 95% CI, the trend could not be ruled out.|Risk Difference (RD)|2.6|||||TWO_SIDED|95.0|-0.7|6.0||||||At least 1 ISR||6.0|-0.7|
72456175|NCT01480258|144435823|OTHER|The risk differences between groups (PR5I group - INFANRIX hexa group) and their 2-sided 95% CI were calculated for the above criteria based on the unstratified Miettinen \& Nurminen method. The aim of the 95% CI was to investigate an overall trend and not any specific difference. If 0.0 was excluded from the 95% CI, the trend could not be ruled out.|Risk Difference (RD)|2.5|||||TWO_SIDED|95.0|-0.9|5.9||||||At least 1 solicited ISR||5.9|-0.9|
72500176|NCT01834404|144530719|SUPERIORITY_OR_OTHER|||||||0.72|TWO_SIDED||||||ANCOVA|||||||0.72
72500177|NCT01834404|144530720|SUPERIORITY_OR_OTHER|||||||0.9|TWO_SIDED||||||ANCOVA|||||||0.90
72620691|NCT01633112|144772485|OTHER||||||<|0.0001|||||||ANCOVA|rank ANCOVA with covariates: adjusted for treatment, age, region, number of relapses experienced in the previous year, and baseline T2 lesion volume.||||||<0.0001
72500178|NCT01834404|144530721|SUPERIORITY_OR_OTHER|||||||0.54|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.54
72500179|NCT01834404|144530722|SUPERIORITY_OR_OTHER|||||||0.26|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.26
72500180|NCT02203149|144530728|SUPERIORITY_OR_OTHER||Difference in Percentage|-2.8|||||TWO_SIDED|95.0|-14.5|10.0|||Miettinen and Nurminen Method|||95% confidence intervals were provided for between-treatment differences in the percentage of participants with events, comparing participants in the Part 2 Immediate Treatment (Grazoprevir + Elbasvir) Arm with the Part 2 Deferred Treatment (Placebo) Arm during the double blinded period through FUWK4. These analyses were performed using the Miettinen and Nurminen method, an unconditional, asymptotic method.||10.0|-14.5|
72500181|NCT02203149|144530729|SUPERIORITY_OR_OTHER||Difference in Percentage|0.0|||||TWO_SIDED|95.0|-6.0|2.8|||Miettinen and Nurminen Method|||95% confidence intervals were provided for between-treatment differences in the percentage of participants with events, comparing participants in the Part 2 Immediate Treatment (Grazoprevir + Elbasvir) Arm with the Part 2 Deferred Treatment (Placebo) Arm during the double blinded period through FUWK4. These analyses were performed using the Miettinen and Nurminen method, an unconditional, asymptotic method.||2.8|-6.0|
72500182|NCT02537678|144530732|NON_INFERIORITY|We planned 0.41 standard deviation (SD) as the non-inferiority margin (which is less than half of the effect size) for the one-side testing. Non-inferiority analysis with alpha 2.5% was applied at post assessment.|Mean Difference (Final Values)|-0.43|STANDARD_ERROR_OF_MEAN|1.43||0.006|ONE_SIDED|97.5|-3.26||||t-test, 1 sided|||Based on the actual randomization of 183 participants (SC-TF-CBT=91; standard TF-CBT=92), we had more than 80% power to show that SC-TF-CBT is at least as effective as standard TF-CBT with alpha of .05 and a non-inferior margin of 0.41 SD units.|Treatment difference = standard Trauma Focused -CBT - stepped care Trauma Focused-CBT||-3.26|.006
72620692|NCT01633112|144772485|OTHER|||||||0.006|||||||ANCOVA|rank ANCOVA with covariates: adjusted for treatment, age, region, number of relapses experienced in the previous year, and baseline T2 lesion volume.||||||0.0060
72620693|NCT01633112|144772486|OTHER|||||||0.0167|||||||negative binomial regression model|adjusted for treatment, age, geog. region, baseline T2 lesion count, baseline Gd-enhancing T1 lesion count, and the number of previous year relapses .||||||0.0167
72456176|NCT01480258|144435823|OTHER|The risk differences between groups (PR5I group - INFANRIX hexa group) and their 2-sided 95% CI were calculated for the above criteria based on the unstratified Miettinen \& Nurminen method. The aim of the 95% CI was to investigate an overall trend and not any specific difference. If 0.0 was excluded from the 95% CI, the trend could not be ruled out.|Risk Difference (RD)|0.1|||||TWO_SIDED|95.0|-1.1|1.4||||||At least 1 systemic AE||1.4|-1.1|
72456177|NCT01480258|144435823|OTHER|The risk differences between groups (PR5I group - INFANRIX hexa group) and their 2-sided 95% CI were calculated for the above criteria based on the unstratified Miettinen \& Nurminen method. The aim of the 95% CI was to investigate an overall trend and not any specific difference. If 0.0 was excluded from the 95% CI, the trend could not be ruled out.|Risk Difference (RD)|0.8|||||TWO_SIDED|95.0|-0.5|2.2||||||At least 1 vaccine-related systemic AE||2.2|-0.5|
72456178|NCT01480258|144435823|OTHER|The risk differences between groups (PR5I group - INFANRIX hexa group) and their 2-sided 95% CI were calculated for the above criteria based on the unstratified Miettinen \& Nurminen method. The aim of the 95% CI was to investigate an overall trend and not any specific difference. If 0.0 was excluded from the 95% CI, the trend could not be ruled out.|Risk Difference (RD)|0.8|||||TWO_SIDED|95.0|-0.5|2.2||||||At least 1 solicited systemic AE||2.2|-0.5|
72456179|NCT01480258|144435823|OTHER|The risk differences between groups (PR5I group - INFANRIX hexa group) and their 2-sided 95% CI were calculated for the above criteria based on the unstratified Miettinen \& Nurminen method. The aim of the 95% CI was to investigate an overall trend and not any specific difference. If 0.0 was excluded from the 95% CI, the trend could not be ruled out.|Risk Difference (RD)|0.9||||||95.0|-0.4|2.3||||||At least 1 vaccine-related solicited systemic AE||2.3|-0.4|
72456180|NCT01480258|144435824|OTHER|The risk differences between groups (PR5I group - INFANRIX hexa group) and their 2-sided 95% CI were calculated for the above criteria based on the unstratified Miettinen \& Nurminen method. The aim of the 95% CI was to investigate whether an overall trend of risk differences existed. If the 95% CI for the risk differences included 0.0, the numerical differences were not considered significant.|Risk Difference (RD)|8.2|||||TWO_SIDED|95.0|3.0|13.3||||||Injection-site erythema||13.3|3.0|
72456181|NCT01480258|144435824|OTHER|The risk differences between groups (PR5I group - INFANRIX hexa group) and their 2-sided 95% CI were calculated for the above criteria based on the unstratified Miettinen \& Nurminen method. The aim of the 95% CI was to investigate whether an overall trend of risk differences existed. If the 95% CI for the risk differences included 0.0, the numerical differences were not considered significant.|Risk Difference (RD)|3.4|||||TWO_SIDED|95.0|-1.5|8.3||||||Injection-site pain||8.3|-1.5|
72456182|NCT01480258|144435824|OTHER|The risk differences between groups (PR5I group - INFANRIX hexa group) and their 2-sided 95% CI were calculated for the above criteria based on the unstratified Miettinen \& Nurminen method. The aim of the 95% CI was to investigate whether an overall trend of risk differences existed. If the 95% CI for the risk differences included 0.0, the numerical differences were not considered significant.|Risk Difference (RD)|7.5||||||95.0|2.1|12.9||||||Injection-site swelling||12.9|2.1|
72500183|NCT02537678|144530733|NON_INFERIORITY|We planned 0.41 standard deviation (SD) as the non-inferiority margin (which is less than half of the effect size) for the one-side testing. Non-inferiority analysis with alpha 2.5% was applied at 6-month assessment.|Mean Difference (Final Values)|-0.53|STANDARD_ERROR_OF_MEAN|1.49||0.004|ONE_SIDED|97.5|-3.47||||t-test, 1 sided|||Based on the actual randomization of 183 participants (SC-TF-CBT=91; standard TF-CBT=92), we had more than 80% power to show that SC-TF-CBT is at least as effective as standard TF-CBT with alpha of .05 and a non-inferior margin of 0.41 SD units.|Treatment difference = standard Trauma Focused -CBT - stepped care Trauma Focused-CBT||-3.47|.004
72456183|NCT01480258|144435825|OTHER|The risk differences between groups (PR5I group - INFANRIX hexa group) and their 2-sided 95% CI were calculated for the above criteria based on the unstratified Miettinen \& Nurminen method. The aim of the 95% CI was to investigate an overall trend and not any specific difference. If 0.0 was excluded from the 95% CI, the trend could not be ruled out.|Risk Difference (RD)|-1.1|||||TWO_SIDED|95.0|-2.5|0.3||||||Injection-site bruising||0.3|-2.5|
72456184|NCT01480258|144435825|OTHER|The risk differences between groups (PR5I group - INFANRIX hexa group) and their 2-sided 95% CI were calculated for the above criteria based on the unstratified Miettinen \& Nurminen method. The aim of the 95% CI was to investigate an overall trend and not any specific difference. If 0.0 was excluded from the 95% CI, the trend could not be ruled out.|Risk Difference (RD)|0.0|||||TWO_SIDED|95.0|-1.5|1.6||||||Injection-site haemorrhage||1.6|-1.5|
72456185|NCT01480258|144435825|OTHER||Risk Difference (RD)|2.6|||||TWO_SIDED|95.0|-1.2|6.4||||||Injection-site induration||6.4|-1.2|
72456186|NCT01480258|144435825|OTHER|The risk differences between groups (PR5I group - INFANRIX hexa group) and their 2-sided 95% CI were calculated for the above criteria based on the unstratified Miettinen \& Nurminen method. The aim of the 95% CI was to investigate an overall trend and not any specific difference. If 0.0 was excluded from the 95% CI, the trend could not be ruled out.|Risk Difference (RD)|0.3|||||TWO_SIDED|95.0|-0.8|1.5||||||Injection-site nodule||1.5|-0.8|
72456187|NCT01480258|144435825|OTHER|The risk differences between groups (PR5I group - INFANRIX hexa group) and their 2-sided 95% CI were calculated for the above criteria based on the unstratified Miettinen \& Nurminen method. The aim of the 95% CI was to investigate an overall trend and not any specific difference. If 0.0 was excluded from the 95% CI, the trend could not be ruled out.|Risk Difference (RD)|1.1||||||95.0|-0.4|2.7||||||Injection-site warmth||2.7|-0.4|
72456188|NCT01480258|144435826|OTHER|The risk differences between groups (PR5I group - INFANRIX hexa group) and their 2-sided 95% CI were calculated for the above criteria based on the unstratified Miettinen \& Nurminen method. The aim of the 95% CI was to investigate whether an overall trend of risk differences existed. If the 95% CI for the risk differences included 0.0, the numerical differences were not considered significant.|Risk Difference (RD)|2.2|||||TWO_SIDED|95.0|-1.3|5.7||||||Crying||5.7|-1.3|
72620694|NCT01633112|144772486|OTHER|||||||0.0011|||||||negative binomial regression model|adjusted for treatment, age, geog. region, baseline T2 lesion count, baseline Gd-enhancing T1 lesion count, and the number of previous year relapses.||||||0.0011
72620695|NCT01633112|144772487|OTHER|||||||0.0052|||||||ANCOVA|ranked ANCOVA with covariates: treatment, region, age, baseline Gd-enhancing T1 lesion volume, and number ofrelapses experienced in the previous year.||||||0.0052
72620696|NCT01633112|144772487|OTHER|||||||0.0636|||||||ANCOVA|ranked ANCOVA with covariates: treatment, region, age, baseline Gd-enhancing T1 lesion volume, and number ofrelapses experienced in the previous year.||||||0.0636
72456189|NCT01480258|144435826|OTHER|The risk differences between groups (PR5I group - INFANRIX hexa group) and their 2-sided 95% CI were calculated for the above criteria based on the unstratified Miettinen \& Nurminen method. If the 95% CI for the risk differences included 0.0, the numerical differences were not considered significant.|Risk Difference (RD)|3.6|||||TWO_SIDED|95.0|-1.6|8.8||||||Decreased appetite||8.8|-1.6|
72456190|NCT01480258|144435826|OTHER|The risk differences between groups (PR5I group - INFANRIX hexa group) and their 2-sided 95% CI were calculated for the above criteria based on the unstratified Miettinen \& Nurminen method. If the 95% CI for the risk differences included 0.0, the numerical differences were not considered significant.|Risk Difference (RD)|2.2|||||TWO_SIDED|95.0|-1.0|5.4||||||Irritability||5.4|-1.0|
72456191|NCT01480258|144435826|OTHER|The risk differences between groups (PR5I group - INFANRIX hexa group) and their 2-sided 95% CI were calculated for the above criteria based on the unstratified Miettinen \& Nurminen method. If the 95% CI for the risk differences included 0.0, the numerical differences were not considered significant.|Risk Difference (RD)|6.4|||||TWO_SIDED|95.0|1.5|11.3||||||Pyrexia||11.3|1.5|
72456192|NCT01480258|144435826|OTHER|The risk differences between groups (PR5I group - INFANRIX hexa group) and their 2-sided 95% CI were calculated for the above criteria based on the unstratified Miettinen \& Nurminen method. The aim of the 95% CI was to investigate an overall trend and not any specific difference. If 0.0 was excluded from the 95% CI, the trend could not be ruled out.|Risk Difference (RD)|5.8|||||TWO_SIDED|95.0|1.7|9.8||||||Somnolence||9.8|1.7|
72456193|NCT01480258|144435826|OTHER|The risk differences between groups (PR5I group - INFANRIX hexa group) and their 2-sided 95% CI were calculated for the above criteria based on the unstratified Miettinen \& Nurminen method. If the 95% CI for the risk differences included 0.0, the numerical differences were not considered significant.|Risk Difference (RD)|1.8|||||TWO_SIDED|95.0|-3.2|6.9||||||Vomiting||6.9|-3.2|
72456194|NCT03316170|144435829|SUPERIORITY||Mean Difference (Final Values)|-0.86|STANDARD_ERROR_OF_MEAN|0.44||0.06|TWO_SIDED|95.0|-1.75|0.3|||t-test, 2 sided|||||0.30|-1.75|.06
72456195|NCT03775915|144435845|OTHER||||||>|0.05||||||p-value calculated for interaction between group and day|Linear Mixed Model|Linear mixed effects model adjusted for baseline, F(2,46) = 1.061, p \>0.05||||||>0.05
72456196|NCT03775915|144435846|SUPERIORITY||||||>|0.05|||||||Mixed Models Analysis|||||||>0.05
72456197|NCT00910962|144435879|SUPERIORITY||Hazard Ratio (HR)|0.79||||0.411|TWO_SIDED|95.0|0.46|1.38|||Cox' proportional hazards model|||||1.38|0.46|0.4110
72456198|NCT00910962|144435879|SUPERIORITY||Hazard Ratio (HR)|1.02||||0.9318|TWO_SIDED|95.0|0.6|1.74|||Cox' proportional hazards model|||||1.74|0.60|0.9318
72456199|NCT00910962|144435879|SUPERIORITY||Hazard Ratio (HR)|0.9||||0.6805|TWO_SIDED|95.0|0.56|1.46|||Cox' proportional hazards model|||||1.46|0.56|0.6805
72456200|NCT00910962|144435880|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.72||||0.299|TWO_SIDED|95.0|0.39|1.34|||Cox' proportional hazards model|||||1.34|0.39|0.2990
72456201|NCT00910962|144435880|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.07||||0.8235|TWO_SIDED|95.0|0.6|1.9|||Cox' proportional hazards model|||||1.90|0.60|0.8235
72456202|NCT00910962|144435880|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.89||||0.659|TWO_SIDED|95.0|0.52|1.51|||Cox' proportional hazards model|||||1.51|0.52|0.6590
72620697|NCT01633112|144772488|OTHER|||||||0.0011||||||adjusted for treatment, region, age, proper baseline T1 lesion variable, baseline Gd-enhancing T1 lesion count and number of previous year relapses.|Regression, Logistic|pair-wise comparisons between treatment groups using a logistic regression model.||||||0.0011
72456203|NCT00910962|144435886|SUPERIORITY||test to reference ratio|0.8||||0.151|TWO_SIDED|95.0|0.59|1.09|||Repeated measures ANCOVA|||||1.09|0.59|0.151
72456204|NCT00910962|144435886|SUPERIORITY||test to reference ratio|0.95||||0.744|TWO_SIDED|95.0|0.7|1.29|||Repeated measures ANCOVA|||||1.29|0.70|0.744
72456205|NCT00910962|144435886|SUPERIORITY||test to treatment ratio|0.87||||0.317|TWO_SIDED|95.0|0.66|1.14|||Repeated measures ANCOVA|||||1.14|0.66|0.317
72456206|NCT00910962|144435887|SUPERIORITY||test to reference ratio|1.03||||0.83|TWO_SIDED|95.0|0.8|1.32|||ANCOVA|||||1.32|0.80|0.83
72456207|NCT00910962|144435887|SUPERIORITY||test to reference ratio|1.08||||0.56|TWO_SIDED|95.0|0.84|1.39|||ANCOVA|||||1.39|0.84|0.56
72456208|NCT00910962|144435887|SUPERIORITY||test to reference ratio|1.05||||0.65|TWO_SIDED|95.0|0.84|1.32|||ANCOVA|||||1.32|0.84|0.65
72456209|NCT00910962|144435888|SUPERIORITY||Test to reference ratio|0.77||||0.04|TWO_SIDED|95.0|0.6|0.99|||Repeated measures ANCOVA|||Placebo (P) vs Losmapimod 7.5 mg (A): For 24 hours||0.99|0.60|0.040
72456210|NCT00910962|144435888|SUPERIORITY||test to reference ratio|0.66||||0.001|TWO_SIDED|95.0|0.52|0.85|||Repeated measures ANCOVA|||Placebo (P) vs Losmapimod 15 mg followed by Losmapimod 7.5 mg (B): For 24 hours||0.85|0.52|0.001
72456211|NCT00910962|144435888|SUPERIORITY||test to reference ratio|0.71||||0.003|TWO_SIDED|95.0|0.57|0.89|||Repeated measures ANCOVA|||Placebo (P) vs A and B Combined (C): For 24 hours||0.89|0.57|0.003
72456212|NCT00910962|144435888|SUPERIORITY||test to reference ratio|0.56|||<|0.001|TWO_SIDED|95.0|0.4|0.78|||Repeated measures ANCOVA|||Placebo (P) vs Losmapimod 7.5 mg (A): For 48 hours||0.78|0.40|<0.001
72456213|NCT00910962|144435888|SUPERIORITY||test to reference ratio|0.47|||<|0.001|TWO_SIDED|95.0|0.33|0.65|||Repeated measures ANCOVA|||Placebo (P) vs Losmapimod 15 mg followed by Losmapimod 7.5 mg (B): For 48 hours||0.65|0.33|<0.001
72456214|NCT00910962|144435888|SUPERIORITY||test to reference ratio|0.51|||<|0.001|TWO_SIDED|95.0|0.38|0.69|||Repeated measures ANCOVA|||Placebo (P) vs A and B Combined (C): For 48 hours||0.69|0.38|<0.001
72456215|NCT00910962|144435888|SUPERIORITY||test to reference ratio|0.68||||0.059|TWO_SIDED|95.0|0.45|1.01|||Repeated measures ANCOVA|||Placebo (P) vs Losmapimod 7.5 mg (A): For 72 hours||1.01|0.45|0.059
72456216|NCT00910962|144435888|SUPERIORITY||test to reference ratio|0.6||||0.013|TWO_SIDED|95.0|0.4|0.9|||Repeated measures ANCOVA|||Placebo (P) vs Losmapimod 15 mg followed by Losmapimod 7.5 mg (B): For 72 hours||0.90|0.40|0.013
72456217|NCT00910962|144435888|SUPERIORITY||test to reference ratio|0.64||||0.015|TWO_SIDED|95.0|0.45|0.92|||Repeated measures ANCOVA|||Placebo (P) vs A and B Combined (C): For 72 hours||0.92|0.45|0.015
72456218|NCT00910962|144435888|SUPERIORITY||test to reference ratio|0.7||||0.073|TWO_SIDED|95.0|0.48|1.03|||Repeated measures ANCOVA|||Placebo (P) vs Losmapimod 7.5 mg (A): For Week 2||1.03|0.48|0.073
72456219|NCT00910962|144435888|SUPERIORITY||test to reference ratio|0.7||||0.075|TWO_SIDED|95.0|0.48|1.04|||Repeated measures ANCOVA|||Placebo (P) vs Losmapimod 15 mg followed by Losmapimod 7.5 mg (B): For Week 2||1.04|0.48|0.075
72456220|NCT00910962|144435888|SUPERIORITY||test to reference ratio|0.7||||0.044|TWO_SIDED|95.0|0.5|0.99|||Repeated measures ANCOVA|||Placebo (P) vs A and B Combined (C): For Week 2||0.99|0.50|0.044
72456221|NCT00910962|144435888|SUPERIORITY||test to reference ratio|0.78||||0.157|TWO_SIDED|95.0|0.55|1.1|||Repeated measures ANCOVA|||Placebo (P) vs Losmapimod 7.5 mg (A): For Week 4||1.10|0.55|0.157
72456222|NCT00910962|144435888|SUPERIORITY||test to reference ratio|0.9||||0.548|TWO_SIDED|95.0|0.63|1.28|||ANCOVA|||Placebo (P) vs Losmapimod 15 mg followed by Losmapimod 7.5 mg (B): For Week 4||1.28|0.63|0.548
72456223|NCT00910962|144435888|SUPERIORITY||test to reference ratio|0.83||||0.253|TWO_SIDED|95.0|0.61|1.14|||Repeated measures ANCOVA|||Placebo (P) vs A and B Combined (C): For Week 4||1.14|0.61|0.253
72456224|NCT00910962|144435888|SUPERIORITY||test to reference ratio|0.8||||0.204|TWO_SIDED|95.0|0.58|1.13|||Repeated measures ANCOVA|||Placebo (P) vs Losmapimod 7.5 mg (A): For Week 8||1.13|0.58|0.204
72456225|NCT00910962|144435888|SUPERIORITY||test to reference ratio|0.99||||0.965|TWO_SIDED|95.0|0.71|1.39|||Repeated measures ANCOVA|||Placebo (P) vs Losmapimod 15 mg followed by Losmapimod 7.5 mg (B): For Week 8||1.39|0.71|0.965
72456226|NCT00910962|144435888|SUPERIORITY||test to reference ratio|0.89||||0.457|TWO_SIDED|95.0|0.66|1.2|||Repeated measures ANCOVA|||Placebo (P) vs A and B Combined (C): For Week 8||1.20|0.66|0.457
72456227|NCT00910962|144435888|SUPERIORITY||test to reference ratio|1.58||||0.008|TWO_SIDED|95.0|1.13|2.22|||Repeated measures ANCOVA|||Placebo (P) vs Losmapimod 7.5 mg (A): For Week 14||2.22|1.13|0.008
72620698|NCT01633112|144772488|OTHER|||||||0.0146||||||adjusted for treatment, region, age, proper baseline T1 lesion variable, baseline Gd-enhancing T1 lesion count and number of previous year relapses.|Regression, Logistic|pair-wise comparisons between treatment groups using a logistic regression model.||||||0.0146
72456228|NCT00910962|144435888|SUPERIORITY||test to reference ratio|1.69||||0.002|TWO_SIDED|95.0|1.21|2.38|||Repeated measures ANCOVA|||Placebo (P) vs Losmapimod 15 mg followed by Losmapimod 7.5 mg (B): For Week 14||2.38|1.21|0.002
72456229|NCT00910962|144435888|SUPERIORITY||test to reference ratio|1.64||||0.001|TWO_SIDED|95.0|1.21|2.21|||Repeated measures ANCOVA|||Placebo (P) vs A and B Combined (C): For Week 14||2.21|1.21|0.001
72456230|NCT00910962|144435889|SUPERIORITY||test to reference ratio|0.54|||<|0.001|TWO_SIDED|95.0|0.43|0.69|||Repeated measures ANCOVA|||Placebo (P) vs Losmapimod 7.5 mg (A): For 24 hours||0.69|0.43|<0.001
72456231|NCT00910962|144435889|SUPERIORITY||test to reference ratio|0.64|||<|0.001|TWO_SIDED|95.0|0.5|0.82|||Repeated measures ANCOVA|||Placebo (P) vs Losmapimod 15 mg followed by Losmapimod 7.5 mg (B): For 24 hours||0.82|0.50|<0.001
72456232|NCT00910962|144435889|SUPERIORITY||test to reference ratio|0.59|||<|0.001|TWO_SIDED|95.0|0.48|0.73|||Repeated measures ANCOVA|||Placebo (P) vs A and B Combined (C): For 24 hours||0.73|0.48|<0.001
72456233|NCT00910962|144435889|SUPERIORITY||test to reference ratio|0.76||||0.031|TWO_SIDED|95.0|0.59|0.98|||Repeated measures ANCOVA|||Placebo (P) vs Losmapimod 7.5 mg (A): For Week 2||0.98|0.59|0.031
72456234|NCT00910962|144435889|SUPERIORITY||test to reference ratio|0.88||||0.315|TWO_SIDED|95.0|0.68|1.13|||Repeated measures ANCOVA|||Placebo (P) vs Losmapimod 15 mg followed by Losmapimod 7.5 mg (B): For Week 2||1.13|0.68|0.315
72456235|NCT00910962|144435889|SUPERIORITY||test to reference ratio|0.82||||0.075|TWO_SIDED|95.0|0.65|1.02|||Repeated measures ANCOVA|||Placebo (P) vs A and B Combined (C): For Week 2||1.02|0.65|0.075
72456236|NCT00910962|144435889|SUPERIORITY||test to reference ratio|0.81||||0.068|TWO_SIDED|95.0|0.65|1.02|||Repeated measures ANCOVA|||Placebo (P) vs Losmapimod 7.5 mg (A): For Week 12||1.02|0.65|0.068
72456237|NCT00910962|144435889|SUPERIORITY||test to reference ratio|0.97||||0.824|TWO_SIDED|95.0|0.78|1.22|||Repeated measures ANCOVA|||Placebo (P) vs Losmapimod 15 mg followed by Losmapimod 7.5 mg (B): For Week 12||1.22|0.78|0.824
72456238|NCT00910962|144435889|SUPERIORITY||test to reference ratio|0.89||||0.246|TWO_SIDED|95.0|0.73|1.09|||Repeated measures ANCOVA|||Placebo (P) vs A and B Combined (C): For Week 12||1.09|0.73|0.246
72456239|NCT00910962|144435890|SUPERIORITY||test to reference ratio|1.04||||0.66|TWO_SIDED|95.0|0.89|1.21|||Repeated measures ANCOVA|||Placebo (P) vs Losmapimod 7.5 mg (A): For 72 hours||1.21|0.89|0.66
72456240|NCT00910962|144435890|SUPERIORITY||test to reference ratio|1.07||||0.39|TWO_SIDED|95.0|0.92|1.25|||Repeated measures ANCOVA|||Placebo (P) vs Losmapimod 15 mg followed by Losmapimod 7.5 mg (B): For 72 hours||1.25|0.92|0.39
72456241|NCT00910962|144435890|SUPERIORITY||test to reference ratio|1.05||||0.47|TWO_SIDED|95.0|0.92|1.21|||Repeated measures ANCOVA|||Placebo (P) vs A and B Combined (C): For 72 hours||1.21|0.92|0.47
72456242|NCT00910962|144435891|SUPERIORITY||test to reference ratio|0.99||||0.92|TWO_SIDED|95.0|0.78|1.25|||Repeated measures ANCOVA|||||1.25|0.78|0.92
72456243|NCT00910962|144435891|SUPERIORITY||test to reference ratio|1.08||||0.52|TWO_SIDED|95.0|0.85|1.36|||Repeated measures ANCOVA|||||1.36|0.85|0.52
72456244|NCT00910962|144435891|SUPERIORITY||test to reference ratio|1.03||||0.76|TWO_SIDED|95.0|0.84|1.27|||Repeated measures ANCOVA|||||1.27|0.84|0.76
72456245|NCT00910962|144435892|SUPERIORITY||test to reference ratio|0.93||||0.57|TWO_SIDED|95.0|0.72|1.2|||Repeated measures ANCOVA|||Placebo (P) vs Losmapimod 7.5 mg (A): For discharge/early withdrawal||1.20|0.72|0.57
72456246|NCT00910962|144435892|SUPERIORITY||test to reference ratio|0.92||||0.52|TWO_SIDED|95.0|0.72|1.18|||Repeated measures ANCOVA|||Placebo (P) vs Losmapimod 15 mg followed by Losmapimod 7.5 mg (B): For discharge/early withdrawal||1.18|0.72|0.52
72456247|NCT00910962|144435892|SUPERIORITY||test to reference ratio|0.92||||0.5|TWO_SIDED|95.0|0.74|1.16|||Repeated measures ANCOVA|||Placebo (P) vs A and B Combined (C): For discharge/early withdrawal||1.16|0.74|0.50
72456248|NCT00910962|144435892|SUPERIORITY||test to reference ratio|0.73||||0.03|TWO_SIDED|95.0|0.55|0.96|||Repeated measures ANCOVA|||Placebo (P) vs Losmapimod 7.5 mg (A): For Week 12||0.96|0.55|0.03
72456249|NCT00910962|144435892|SUPERIORITY||test to reference ratio|0.81||||0.14|TWO_SIDED|95.0|0.61|1.07|||Repeated measures ANCOVA|||Placebo (P) vs Losmapimod 15 mg followed by Losmapimod 7.5 mg (B): For Week 12||1.07|0.61|0.14
72456250|NCT00910962|144435892|SUPERIORITY||test to reference ratio|0.76||||0.04|TWO_SIDED|95.0|0.6|0.98|||Repeated measures ANCOVA|||Placebo (P) vs A and B Combined (C): For Week 12||0.98|0.60|0.04
72620699|NCT01633112|144772489|OTHER||||||<|0.0001|||||||Wilcoxon signed-rank test|Global Satisfaction (Month 6): p-values for within treatment comparison from baseline||||||<0.0001
72620700|NCT01633112|144772489|OTHER||||||<|0.0001|||||||Wilcoxon signed-rank test|Global Satisfaction (Month 6): p-values for within treatment comparison from baseline||||||<0.0001
72620701|NCT01633112|144772489|OTHER||||||<|0.0001|||||||Wilcoxon signed-rank test|Global Satisfaction (Month 6): p-values for within treatment comparison from baseline||||||<0.0001
72456251|NCT00910962|144435893|SUPERIORITY||Mean Difference (Final Values)|-1.92||||0.254|TWO_SIDED|95.0|-5.25|1.41|||Repeated measures ANCOVA|||Placebo (P) vs Losmapimod 7.5 mg (A): For Day 3-5 (visit 1)||1.41|-5.25|0.254
72456252|NCT00910962|144435893|SUPERIORITY||Mean Difference (Final Values)|-2.84||||0.106|TWO_SIDED|95.0|-6.29|0.62|||Repeated measures ANCOVA|||Placebo (P) vs Losmapimod 15 mg followed by Losmapimod 7.5 mg (B): For Day 3-5 (visit 1)||0.62|-6.29|0.106
72456253|NCT00910962|144435893|SUPERIORITY||Mean Difference (Final Values)|-2.38||||0.126|TWO_SIDED|95.0|-5.44|0.69|||Repeated measures ANCOVA|||Placebo (P) vs A and B Combined (C): For Day 3-5 (visit 1)||0.69|-5.44|0.126
72456254|NCT00910962|144435893|SUPERIORITY||Mean Difference (Final Values)|-1.91||||0.184|TWO_SIDED|95.0|-4.74|0.92|||Repeated measures ANCOVA|||Placebo (P) vs Losmapimod 7.5 mg (A): For Week 12||0.92|-4.74|0.184
72456255|NCT00910962|144435893|SUPERIORITY||Mean Difference (Final Values)|-2.47||||0.093|TWO_SIDED|95.0|-5.37|0.43|||Repeated measures ANCOVA|||Placebo (P) vs Losmapimod 15 mg followed by Losmapimod 7.5 mg (B): For Week 12||0.43|-5.37|0.093
72456256|NCT00910962|144435893|SUPERIORITY||Mean Difference (Final Values)|-2.19||||0.096|TWO_SIDED|95.0|-4.78|0.4|||Repeated measures ANCOVA|||Placebo (P) vs A and B Combined (C): For Week 12||0.40|-4.78|0.096
72456257|NCT00910962|144435894|SUPERIORITY||Mean Difference (Final Values)|4.22||||0.124|TWO_SIDED|95.0|-1.18|9.62|||Repeated measures ANCOVA|||||9.62|-1.18|0.124
72456258|NCT00910962|144435894|SUPERIORITY||Mean Difference (Final Values)|6.05||||0.029|TWO_SIDED|95.0|0.63|11.47|||Repeated measures ANCOVA|||||11.47|0.63|0.029
72456259|NCT00910962|144435894|SUPERIORITY||Mean Difference (Final Values)|5.14||||0.039|TWO_SIDED|95.0|0.28|10.0|||Repeated measures ANCOVA|||||10.00|0.28|0.039
72456260|NCT00910962|144435895|SUPERIORITY||Mean Difference (Final Values)|-21.53||||0.025|TWO_SIDED|95.0|-40.27|-2.79|||Repeated measures ANCOVA|||Placebo (P) vs Losmapimod 7.5 mg (A): For LVEDV||-2.79|-40.27|0.025
72456261|NCT00910962|144435895|SUPERIORITY||Mean Difference (Final Values)|-18.65||||0.053|TWO_SIDED|95.0|-37.58|0.29|||Repeated measures ANCOVA|||Placebo (P) vs Losmapimod 15 mg followed by Losmapimod 7.5 mg (B): For LVEDV||0.29|-37.58|0.053
72456262|NCT00910962|144435895|SUPERIORITY||Mean Difference (Final Values)|-20.09||||0.021|TWO_SIDED|95.0|-37.01|-3.18|||Repeated measures ANCOVA|||Placebo (P) vs A and B Combined (C): For LVEDV||-3.18|-37.01|0.021
72456263|NCT00910962|144435895|SUPERIORITY||Mean Difference (Final Values)|-15.82||||0.024|TWO_SIDED|95.0|-29.51|-2.14|||Repeated measures ANCOVA|||Placebo (P) vs Losmapimod 7.5 mg (A): For LVESV||-2.14|-29.51|0.024
72456264|NCT00910962|144435895|SUPERIORITY||Mean Difference (Final Values)|-17.22||||0.016|TWO_SIDED|95.0|-31.14|-3.29|||Repeated measures ANCOVA|||Placebo (P) vs Losmapimod 15 mg followed by Losmapimod 7.5 mg (B): For LVESV||-3.29|-31.14|0.016
72563006|NCT00292227|144658084|NON_INFERIORITY_OR_EQUIVALENCE|A standard deviation of 12ms was assumed for sample size calculation. Sample size was calculated to have 90% power to show the non-inferiority of rotigotine against placebo with respect to the non-inferiority margin of 10ms (α=0.05, 1-sided).|Mean Difference (Net)|0.07||||||90.0|-2.14|2.28|||ANCOVA|The ANCOVA model included the factors site, treatment, gender, and time-matched baseline QTcI as covariate.|The direction of the estimate is Rotigotine - Placebo. Mean difference was estimated from the ANCOVA model.|The analysis was based on a non-inferiority comparison of rotigotine vs placebo using a 1-sided 95% confidence interval (or, equivalently, the upper limit of 2-sided 90% confidence interval) for the time-matched changes from Baseline in QTcI.||2.28|-2.14|
72456265|NCT00910962|144435895|SUPERIORITY||Mean Difference (Final Values)|-16.52||||0.01|TWO_SIDED|95.0|-28.91|-4.13|||Repeated measures ANCOVA|||Placebo (P) vs A and B Combined (C): For LVESV||-4.13|-28.91|0.010
72456266|NCT00910962|144435896|SUPERIORITY||Mean Difference (Final Values)|-22.21||||0.109|TWO_SIDED|95.0|-49.51|5.09|||Repeated measures ANCOVA|||||5.09|-49.51|0.109
72456267|NCT00910962|144435896|SUPERIORITY||Mean Difference (Final Values)|-7.13||||0.614|TWO_SIDED|95.0|-35.22|20.96|||Repeated measures ANCOVA|||||20.96|-35.22|0.614
72456268|NCT00910962|144435896|SUPERIORITY||Mean Difference (Final Values)|-14.67||||0.243|TWO_SIDED|95.0|-39.52|10.18|||Repeated measures ANCOVA|||||10.18|-39.52|0.243
72456269|NCT00910962|144435897|SUPERIORITY||Mean Difference (Final Values)|-0.23||||0.023|TWO_SIDED|95.0|-0.44|-0.03|||Repeated measures ANCOVA|||||-0.03|-0.44|0.023
72456270|NCT00910962|144435897|SUPERIORITY||Mean Difference (Final Values)|-0.24||||0.021|TWO_SIDED|95.0|-0.45|-0.04|||Repeated measures ANCOVA|||||-0.04|-0.45|0.021
72456271|NCT00910962|144435897|SUPERIORITY||Mean Difference (Final Values)|-0.24||||0.011|TWO_SIDED|95.0|-0.42|-0.06|||Repeated measures ANCOVA|||||-0.06|-0.42|0.011
72456272|NCT00910962|144435898|SUPERIORITY||Mean Difference (Final Values)|-0.11||||0.137|TWO_SIDED|95.0|-0.26|0.04|||Repeated measures ANCOVA|||||0.04|-0.26|0.137
72456273|NCT00910962|144435898|SUPERIORITY||Mean Difference (Final Values)|-0.17||||0.036|TWO_SIDED|95.0|-0.32|-0.01|||Repeated measures ANCOVA|||||-0.01|-0.32|0.036
72456274|NCT00910962|144435898|SUPERIORITY||Mean Difference (Final Values)|-0.14||||0.047|TWO_SIDED|95.0|-0.28|0.0|||Repeated measures ANCOVA|||||-0.00|-0.28|0.047
72456275|NCT02336958|144435923|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Fisher Exact|||||||1.0
72456276|NCT02336958|144435924|SUPERIORITY_OR_OTHER|||||||0.459|TWO_SIDED||||||t-test, 2 sided|||||||0.459
72456277|NCT02234141|144435925|OTHER|Nonparametric pairwise comparison|||||=|0.214||||||P-value was calculated using the generalized van Elteren test/van Elteren test (gvE/vE; stratified Wilcoxon rank sum test).|gvE/vE|||The protocol-specified primary analysis was to compare each selonsertib dose group with the placebo group, using Wilcoxon (van Elteren) test, with respect to change from baseline in PVR at Week 24, stratifying by randomization stratum (the underlying etiology of PAH idiopathic/heritable \[yes/no\] and the number of background PAH therapies they were receiving {1, 2, or greater than or equal to \[≥\] 3}).||||= 0.214
72456278|NCT02234141|144435925|OTHER|Nonparametric pairwise comparison|||||=|0.27||||||P-value was calculated using the generalized van Elteren test/van Elteren test (gvE/vE; stratified Wilcoxon rank sum test).|gvE/vE|||The protocol-specified primary analysis was to compare each selonsertib dose group with the placebo group, using Wilcoxon (van Elteren) test, with respect to change from baseline in PVR at Week 24, stratifying by randomization stratum (the underlying etiology of PAH idiopathic/heritable \[yes/no\] and the number of background PAH therapies they were receiving \[1, 2, or ≥ 3\]).||||= 0.270
72620702|NCT01633112|144772489|OTHER||||||<|0.0001|||||||Wilcoxon signed-rank test|Global Satisfaction (Month 12): p-values for within treatment comparison from baseline||||||<0.0001
72620703|NCT01633112|144772489|OTHER||||||<|0.0001|||||||Wilcoxon signed-rank test|Global Satisfaction (Month 12): p-values for within treatment comparison from baseline||||||<0.0001
72456279|NCT02234141|144435925|OTHER|Nonparametric pairwise comparison|||||=|0.604||||||P-value was calculated using the generalized van Elteren test/van Elteren test (gvE/vE; stratified Wilcoxon rank sum test)|gvE/vE|||The protocol-specified primary analysis was to compare each selonsertib dose group with the placebo group, using Wilcoxon (van Elteren) test, with respect to change from baseline in PVR at Week 24, stratifying by randomization stratum (the underlying etiology of PAH idiopathic/heritable \[yes/no\] and the number of background PAH therapies they were receiving \[1, 2, or ≥ 3\]).||||= 0.604
72456280|NCT02037568|144435963|SUPERIORITY|||||||0.96|||||||Mixed Models Analysis|||||||.96
72456281|NCT02037568|144435964|SUPERIORITY|||||||0.007|||||||Mixed Models Analysis|||||||0.007
72456282|NCT02037568|144435965|SUPERIORITY|||||||0.08|||||||Mixed Models Analysis|||||||0.08
72456283|NCT02037568|144435966|SUPERIORITY|||||||0.05|||||||Mixed Models Analysis|||||||0.05
72456284|NCT02037568|144435967|SUPERIORITY|||||||0.07|||||||Mixed Models Analysis|||||||0.070
72456285|NCT02037568|144435968|SUPERIORITY|||||||0.96|||||||Mixed Models Analysis|||||||0.96
72456286|NCT02037568|144435969|SUPERIORITY|||||||0.74|||||||Mixed Models Analysis|||||||0.74
72456287|NCT02037568|144435970|SUPERIORITY|||||||0.79|||||||Mixed Models Analysis|||||||0.79
72456288|NCT02037568|144435971|SUPERIORITY|||||||0.86|||||||Mixed Models Analysis|||||||0.86
72456289|NCT00621842|144435972|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.5|||<|0.01|TWO_SIDED|95.0|-18.0|-12.9|||t-test, 2 sided|df=53||The null hypothesis is that the mean difference score between the 12 week time point or LOCF and baseline is zero.||-12.9|-18.0|<.01
72456290|NCT00621842|144435974|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.2|||<|0.01|TWO_SIDED|95.0|-17.5|-12.9|||t-test, 2 sided|||The null hypothesis is that the mean difference score between the 12 week time point or LOCF and baseline is zero.||-12.9|-17.5|<.01
72456291|NCT00621842|144435975|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.47||||0.49|TWO_SIDED|95.0|-1.82|0.88|||t-test, 2 sided|||The null hypothesis is that the mean difference score between the 12 week time point or LOCF and baseline is zero.||.88|-1.82|.49
72456292|NCT00621842|144435976|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.06|||<|0.01|TWO_SIDED|95.0|-2.43|-1.68|||t-test, 2 sided|||The null hypothesis is that the mean difference between the 12 week time point or LOCF and baseline is zero.||-1.68|-2.43|<.01
72456293|NCT00621842|144435977|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.04||||0.8|TWO_SIDED|95.0|-0.36|0.28|||t-test, 2 sided|||The null hypothesis is that the mean difference between the 12 week time point or LOCF and baseline is zero.||.28|-.36|.80
72456294|NCT00621842|144435978|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.83||||0.36||95.0|-0.97|2.62|||t-test, 2 sided|||The null hypothesis is that the mean difference between the 12 week time point or LOCF and baseline is zero.||2.62|-.97|.36
72456295|NCT00621842|144435980|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.79||||0.08|TWO_SIDED|95.0|-1.67|0.09|||t-test, 2 sided|||The null hypothesis is that the mean difference between the 12 week time point or LOCF and baseline is zero.||.09|-1.67|.08
72456296|NCT00621842|144435981|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.53||||0.04||95.0|-1.03|-0.04|||t-test, 2 sided|||The null hypothesis is that the mean difference between the 12 week time point or LOCF and baseline is zero.||-.04|-1.03|.04
72456297|NCT04604652|144435984|OTHER||||||=|0.077|||||||t-test, 1 sided|||A t-test was performed to test for the percent change from baseline to Week 12. This analysis was based on observed data without imputation. Testing was one sided using a 5% alpha level. No multiplicity adjustment was used, and the p-values reported for the endpoints were descriptive in nature.||||=0.077
72456298|NCT03692871|144435993|OTHER||Difference in Percentage|7.9|||=|0.003|TWO_SIDED|95.0|2.8|12.8|||Miettinen & Nurminen method|||Injection-site erythema||12.8|2.8|= 0.003
72456299|NCT03692871|144435993|OTHER||Difference in Percentage|-0.3|||=|0.882|TWO_SIDED|95.0|-5.0|4.0|||Miettinen & Nurminen method|||Injection-site induration||4.0|-5.0|= 0.882
72456300|NCT03692871|144435993|OTHER||Difference in Percentage|6.4|||=|0.014|TWO_SIDED|95.0|1.3|11.3|||Miettinen & Nurminen method|||Injection-site pain||11.3|1.3|= 0.014
72456301|NCT03692871|144435993|OTHER||Difference in Percentage|4.6|||=|0.051|TWO_SIDED|95.0|0.0|8.9|||Miettinen & Nurminen method|||Injection-site swelling||8.9|0.0|= 0.051
72456302|NCT03692871|144435994|OTHER||Difference in Percentage|5.5|||=|0.033|TWO_SIDED|95.0|0.4|10.5|||Miettinen & Nurminen method|||Decreased appetite||10.5|0.4|= 0.033
72456303|NCT03692871|144435994|OTHER||Difference in Percentage|5.6|||=|0.016|TWO_SIDED|95.0|1.0|10.5|||Miettinen & Nurminen method|||Irritability||10.5|1.0|= 0.016
72456304|NCT03692871|144435994|OTHER||Difference in Percentage|0.4|||=|0.878|TWO_SIDED|95.0|-4.7|5.6|||Miettinen & Nurminen method|||Somnolence||5.6|-4.7|= 0.878
72456305|NCT03692871|144435994|OTHER||Difference in Percentage|-0.8|||=|0.503|TWO_SIDED|95.0|-3.8|1.5|||Miettinen & Nurminen method|||Urticaria||1.5|-3.8|= 0.503
72456306|NCT03692871|144435995|OTHER||Difference in Percentage|0.1|||||TWO_SIDED|95.0|-0.8|0.4||||||Percentage of participants with a vaccine-related SAE||0.4|-0.8|
72456307|NCT03182244|144436005|SUPERIORITY||Hazard Ratio (HR)|0.612||||0.00152|TWO_SIDED|95.0|0.451|0.832|||Log Rank|Stratification factors were response to first-line AML therapy and preselected salvage chemotherapy per interactive response technology (IRT).|Based on Cox proportional hazard model. Assuming proportional hazards, an HR \< 1 indicates a reduction in hazard rate where the numerator is the Gilteritinib arm and the denominator is the Salvage chemotherapy arm.|||0.832|0.451|0.00152
72456308|NCT03182244|144436006|SUPERIORITY||Hazard Ratio (HR)|0.589||||5e-05|TWO_SIDED|95.0|0.438|0.792|||Log Rank|Stratification factors were response to first-line AML therapy and preselected salvage chemotherapy per IRT.|Based on Cox proportional hazard model. Assuming proportional hazards, an HR \< 1 indicates a reduction in hazard rate where the numerator is the Gilteritinib arm and the denominator is the Salvage chemotherapy arm.|||0.792|0.438|0.00005
72456309|NCT03182244|144436007|SUPERIORITY||Treatment difference|8.9||||0.04256|TWO_SIDED|95.0|0.3|17.5|||Cochran-Mantel-Haenszel|Stratification factors: first-line AML therapy \& preselected salvage chemotherapy/IRT response. Treatment difference based on stratification factors.||||17.5|0.3|0.04256
72456310|NCT03182244|144436008|SUPERIORITY||Hazard Ratio (HR)|1.163||||0.8871|TWO_SIDED|95.0|0.131|10.338|||Log Rank|Stratification factors were response to first-line AML therapy and preselected salvage chemotherapy per IRT.|Based on Cox proportional hazard model. Assuming proportional hazards, an HR \< 1 indicates a reduction in hazard rate where the numerator is the Gilteritinib arm and the denominator is the Salvage chemotherapy arm.|||10.338|0.131|0.88710
72456311|NCT03182244|144436009|SUPERIORITY||Hazard Ratio (HR)|0.71||||0.55969|TWO_SIDED|95.0|0.209|2.414|||Log Rank|Stratification factors were response to first-line AML therapy and preselected salvage chemotherapy per IRT.|Based on Cox proportional hazard model. Assuming proportional hazards, an HR \< 1 indicates a reduction in hazard rate where the numerator is the Gilteritinib arm and the denominator is the Salvage chemotherapy arm.|||2.414|0.209|0.55969
72456312|NCT03182244|144436010|SUPERIORITY||Hazard Ratio (HR)|1.583||||0.66261|TWO_SIDED|95.0|0.192|13.048|||Log Rank|Stratification factors were response to first-line AML therapy and preselected salvage chemotherapy per IRT.|Based on Cox proportional hazard model. Assuming proportional hazards, an HR \< 1 indicates a reduction in hazard rate where the numerator is the Gilteritinib arm and the denominator is the Salvage chemotherapy arm.|||13.048|0.192|0.66261
72456313|NCT03182244|144436011|SUPERIORITY||Hazard Ratio (HR)|0.756||||0.55731|TWO_SIDED|95.0|0.286|1.999|||Log Rank|Stratification factors were response to first-line AML therapy and preselected salvage chemotherapy per IRT.|Based on Cox proportional hazard model. Assuming proportional hazards, an HR \< 1 indicates a reduction in hazard rate where the numerator is the Gilteritinib arm and the denominator is the Salvage chemotherapy arm.|||1.999|0.286|0.55731
72456314|NCT03182244|144436012|SUPERIORITY||Treatment difference|17.7||||0.00049|TWO_SIDED|95.0|7.9|27.5|||Cochran-Mantel-Haenszel|Stratification factors: first-line AML therapy \& preselected salvage chemotherapy/IRT response. Treatment difference based on stratification factors.||||27.5|7.9|0.00049
72456315|NCT03182244|144436014|SUPERIORITY||Hazard Ratio (HR)|0.857||||0.56944|TWO_SIDED|95.0|0.494|1.487|||Log Rank|Stratification factors were response to first-line AML therapy and preselected salvage chemotherapy per IRT.|Based on Cox proportional hazard model. Assuming proportional hazards, an HR \< 1 indicates a reduction in hazard rate where the numerator is the Gilteritinib arm and the denominator is the Salvage chemotherapy arm.|||1.487|0.494|0.56944
72456316|NCT03182244|144436015|SUPERIORITY||Treatment difference|31.2|||<|1e-05|TWO_SIDED|95.0|20.2|42.3|||Cochran-Mantel-Haenszel|Stratification factors: first-line AML therapy \& preselected salvage chemotherapy/IRT response. Treatment difference based on stratification factors.||||42.3|20.2|<0.00001
72456317|NCT03182244|144436021|SUPERIORITY||Treatment difference|14.7||||0.00055|TWO_SIDED|95.0|6.5|22.8|||Cochran-Mantel-Haenszel|Stratification factors: first-line AML therapy \& preselected salvage chemotherapy/IRT response. Treatment difference based on stratification factors.||||22.8|6.5|0.00055
72456318|NCT03182244|144436022|SUPERIORITY||Least square mean difference|0.6||||0.14841||||||Analysis of covariance (ANCOVA) including treatment as a fixed factor, baseline score, response to first-line AML therapy and preselected salvage chemotherapy per IRT as covariates. LS Mean difference was estimated using chemotherapy as control.|ANCOVA|||||||0.14841
72456319|NCT00257894|144436030|SUPERIORITY_OR_OTHER|||||||0.57||||||Effect size close to zero (eta squared of .01)|ANOVA|Interaction effect term from group by time ANOVA||||||.57
72456320|NCT00257894|144436031|SUPERIORITY_OR_OTHER|||||||0.6||||||Effect size about zero (eta squared = .01)|ANOVA|Interaction term from a group by time ANOVA||||||.60
72456321|NCT00257894|144436032|SUPERIORITY_OR_OTHER|||||||0.79||||||Effect size (eta squared) = 0|ANOVA|Interaction term of a group by time ANOVA||||||.79
72456322|NCT00257894|144436033|SUPERIORITY_OR_OTHER|||||||0.21||||||For test of drug by time interaction effect|ANOVA|Medium effect size, eta squared = .061||Analysis of variance, group by time (Day 0 vs. Day 10).||||.21
72456323|NCT01316913|144436035|SUPERIORITY_OR_OTHER||Least squares mean difference|0.022||||0.377|TWO_SIDED|95.0|-0.027|0.072|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least squares mean difference=UMEC/VI 62.5/25 µg minus UMEC 125 µg.|||0.072|-0.027|0.377
72456324|NCT01316913|144436035|SUPERIORITY_OR_OTHER||Least squares mean difference|0.06||||0.018|TWO_SIDED|95.0|0.01|0.109||nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least squares mean difference=UMEC/VI 62.5/25 µg minus TIO 18 µg.|||0.109|0.010|0.018
72456325|NCT01316913|144436035|SUPERIORITY_OR_OTHER||Least squares mean difference|0.037||||0.142|TWO_SIDED|95.0|-0.012|0.087|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least squares mean difference=UMEC/VI 125/25 µg minus UMEC 125 µg.|||0.087|-0.012|0.142
72456326|NCT01316913|144436035|SUPERIORITY_OR_OTHER||Least squares mean difference|0.074||||0.003|TWO_SIDED|95.0|0.025|0.123|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least squares mean difference=UMEC/VI 125/25 µg minus TIO 18 µg.|||0.123|0.025|0.003
72456327|NCT00786188|144436046|SUPERIORITY_OR_OTHER|||||||0.0177||||||Week 4 frequency|Repeated measures analysis|||||||0.0177
72456328|NCT00786188|144436046|SUPERIORITY_OR_OTHER|||||||0.0541||||||Week 8 frequency|Reapeated measures analysis|||||||0.0541
72456329|NCT00786188|144436047|SUPERIORITY_OR_OTHER|||||||0.0644||||||Week 4 severity|Reapeated measures analysis|||||||0.0644
72456330|NCT00786188|144436047|SUPERIORITY_OR_OTHER|||||||0.0364||||||Week 8 severity|Reapeated measures analysis|||||||0.0364
72456331|NCT03055988|144436089|SUPERIORITY||Adjusted mean difference|-0.537|STANDARD_ERROR_OF_MEAN|1.12||0.6331|TWO_SIDED|95.0|-2.779|1.705|||Mixed model repeated measures (MMRM)|Kenward-Roger approximation was used to estimate denominator degrees of freedom.|Mean difference means the treatment difference vs. F+S (i.e. T+O 5/5 - F+S 1000/100).|Mixed model repeated measures (MMRM) model included treatment and period as fixed effects, patient as a random effect and baseline as covariate. Unstructured covariance structure was used for within patient variation. H0: Mean change from baseline in LVEDVI for (Tiotropium + Olodaterol) = Mean change from baseline in LVEDVI for (Fluticasone propionate + Salmeterol)||1.705|-2.779|0.6331
72456332|NCT03055988|144436090|SUPERIORITY||Adjusted mean difference|0.001|STANDARD_ERROR_OF_MEAN|0.036||0.9817|TWO_SIDED|95.0|-0.072|0.074|||Mixed model repeated measures (MMRM)|Kenward-Roger approximation was used to estimate denominator degrees of freedom.|Mean difference means the treatment difference vs. F+S (i.e. T+O 5/5 - F+S 1000/100).|MMRM model included treatment and period as fixed effects, patient as a random effect and baseline as covariate. Unstructured covariance structure was used for within patient variation.||0.074|-0.072|0.9817
72456333|NCT03055988|144436091|SUPERIORITY||Adjusted mean difference|1.28|STANDARD_ERROR_OF_MEAN|1.995||0.5238|TWO_SIDED|95.0|-2.719|5.279|||Mixed model repeated measures (MMRM)|Kenward-Roger approximation was used to estimate denominator degrees of freedom.|Mean difference means the treatment difference vs. F+S (i.e. T+O 5/5 - F+S 1000/100).|MMRM model included treatment and period as fixed effects, patient as a random effect and baseline as covariate. Unstructured covariance structure was used for within patient variation.||5.279|-2.719|0.5238
72563007|NCT00292227|144658085|NON_INFERIORITY_OR_EQUIVALENCE|A standard deviation of 12ms was assumed for sample size calculation. Sample size was calculated to have 90% power to show the non-inferiority of rotigotine against placebo with respect to the non-inferiority margin of 10ms (α=0.05, 1-sided).|Mean Difference (Net)|-0.56||||||90.0|-2.84|1.72|||ANCOVA|The ANCOVA model included the factors site, treatment, gender, and time-matched baseline QTcI as covariate.|The direction of the estimate is Rotigotine - Placebo. Mean difference was estimated from the ANCOVA model.|The analysis was based on a non-inferiority comparison of rotigotine vs placebo using a 1-sided 95% confidence interval (or, equivalently, the upper limit of 2-sided 90% confidence interval) for the time-matched changes from Baseline in QTcI.||1.72|-2.84|
72620704|NCT01633112|144772489|OTHER||||||<|0.0001|||||||Wilcoxon signed-rank test|Global Satisfaction (Month 12): p-values for within treatment comparison from baseline||||||<0.0001
72620705|NCT01633112|144772489|OTHER||||||<|0.0001|||||||Wilcoxon signed-rank test|Effectiveness (Month 6): p-values for within treatment comparison from baseline||||||<0.0001
72620706|NCT01633112|144772489|OTHER||||||<|0.0001|||||||Wilcoxon signed-rank test|Effectiveness (Month 6): p-values for within treatment comparison from baseline||||||<0.0001
72456334|NCT03055988|144436092|SUPERIORITY||Adjusted mean difference|2.069|STANDARD_ERROR_OF_MEAN|1.853||0.2687|TWO_SIDED|95.0|-1.64|5.779|||Mixed model repeated measures (MMRM)|Kenward-Roger approximation was used to estimate denominator degrees of freedom.|Mean difference means the treatment difference vs. F+S (i.e. T+O 5/5 - F+S 1000/100).|MMRM model included treatment and period as fixed effects, patient as a random effect and baseline as covariate. Unstructured covariance structure was used for within patient variation.||5.779|-1.640|0.2687
72456335|NCT03055988|144436093|SUPERIORITY||Adjusted mean difference|0.409|STANDARD_ERROR_OF_MEAN|1.335||0.7604|TWO_SIDED|95.0|-2.264|3.082|||Mixed model repeated measures (MMRM)|Kenward-Roger approximation was used to estimate denominator degrees of freedom.|Mean difference means the treatment difference vs. F+S (i.e. T+O 5/5 - F+S 1000/100).|MMRM model included treatment and period as fixed effects, patient as a random effect and baseline as covariate. Unstructured covariance structure was used for within patient variation.||3.082|-2.264|0.7604
72456336|NCT03055988|144436094|SUPERIORITY||Adjusted mean difference|-0.32|STANDARD_ERROR_OF_MEAN|1.509||0.833|TWO_SIDED|95.0|-3.341|2.702|||Mixed model repeated measures (MMRM)|Kenward-Roger approximation was used to estimate denominator degrees of freedom.|Mean difference means the treatment difference vs. F+S (i.e. T+O 5/5 - F+S 1000/100).|MMRM model included treatment and period as fixed effects, patient as a random effect and baseline as covariate. Unstructured covariance structure was used for within patient variation.||2.702|-3.341|0.8330
72456337|NCT03055988|144436095|SUPERIORITY||Adjusted mean difference|-7.957|STANDARD_ERROR_OF_MEAN|2.452||0.0019|TWO_SIDED|95.0|-12.865|-3.05|||Mixed model repeated measures (MMRM)|Kenward-Roger approximation was used to estimate denominator degrees of freedom.|Mean difference means the treatment difference vs. F+S (i.e. T+O 5/5 - F+S 1000/100).|MMRM model included treatment and period as fixed effects, patient as a random effect and baseline as covariate. Unstructured covariance structure was used for within patient variation.||-3.050|-12.865|0.0019
72456338|NCT03055988|144436096|SUPERIORITY||Adjusted mean difference|0.18|STANDARD_ERROR_OF_MEAN|0.029|<|0.0001|TWO_SIDED|95.0|0.121|0.24|||Mixed model repeated measures (MMRM)|Kenward-Roger approximation was used to estimate denominator degrees of freedom.|Mean difference means the treatment difference vs. F+S (i.e. T+O 5/5 - F+S 1000/100).|MMRM model included treatment and period as fixed effects, patient as a random effect and baseline as covariate. Unstructured covariance structure was used for within patient variation.||0.240|0.121|<0.0001
72456339|NCT03055988|144436097|SUPERIORITY||Adjusted mean difference|0.286|STANDARD_ERROR_OF_MEAN|0.057|<|0.0001|TWO_SIDED|95.0|0.171|0.4|||Mixed model repeated measures (MMRM)|Kenward-Roger approximation was used to estimate denominator degrees of freedom.|Mean difference means the treatment difference vs. F+S (i.e. T+O 5/5 - F+S 1000/100).|MMRM model included treatment and period as fixed effects, patient as a random effect and baseline as covariate. Unstructured covariance structure was used for within patient variation.||0.400|0.171|<0.0001
72456340|NCT01736475|144436101|SUPERIORITY_OR_OTHER_LEGACY||Ratio of means|0.1|||<|0.0001|TWO_SIDED|95.0|0.06|0.19|||Regression, Negative binomial|||Ratio Annualized Bleeding Rate (ABR) Prophylaxis/On-demand: Prophylaxis treatment w ill be considered to be successful if the upper limit of the 95% CI for the ratio between treatment regimen does not exceed 0.5 (corresponding to a 50% reduction of the mean ABR compared to the on-demand treatment). H01: μ1 ≥0.5\*μ2 Ha1: μ1\<0.5\*μ2 w here μ1 and μ2 are the mean ABRs in on prophylaxis and on-demand, respectively||0.19|0.06|<0.0001
72620707|NCT01633112|144772489|OTHER||||||<|0.0001|||||||Wilcoxon signed-rank test|Effectiveness (Month 6): p-values for within treatment comparison from baseline||||||<0.0001
72456341|NCT02334215|144436159|SUPERIORITY|||||||0.32|||||||Generalized Linear Mixed Model Analysis|||Contrast of interest: Methadone plus Patient Navigation and Methadone arms compared to Enhanced Treatment as Usual||||.32
72456342|NCT02334215|144436159|SUPERIORITY|||||||0.32|||||||Generalized Linear Mixed Model Analysis|||Contrast of interest: Methadone plus Patient Navigation vs. Methadone||||.32
72456343|NCT02334215|144436160|SUPERIORITY|||||||0.001|||||||Generalized Linear Mixed Model Analysis|||Contrast of Interest: Methadone plus Patient Navigation and Methadone Conditions combined vs. Enhanced Treatment as Usual Conditions||||.001
72456344|NCT02334215|144436160|SUPERIORITY|||||||0.84|||||||Generalized Linear Mixed Model Analysis|||Contrast of interest: Methadone plus Patient Navigation vs. Enhanced Treatment as Usual||||.84
72620708|NCT01633112|144772489|OTHER||||||<|0.0001|||||||Wilcoxon signed-rank test|Effectiveness (Month 12): p-values for within treatment comparison from baseline||||||<0.0001
72620709|NCT01633112|144772489|OTHER||||||<|0.0001|||||||Wilcoxon signed-rank test|Effectiveness (Month 12): p-values for within treatment comparison from baseline||||||<0.0001
72620710|NCT01633112|144772489|OTHER||||||<|0.0001|||||||Wilcoxon signed-rank test|Effectiveness (Month 12): p-values for within treatment comparison from baseline||||||<0.0001
72620711|NCT01633112|144772489|OTHER||||||<|0.0001|||||||Wilcoxon signed-rank test|Side Effects (Month 6): p-values for within treatment comparison from baseline||||||<0.0001
72620712|NCT01633112|144772489|OTHER||||||<|0.0001|||||||Wilcoxon signed-rank test|Side Effects (Month 6): p-values for within treatment comparison from baseline||||||<0.0001
72620713|NCT01633112|144772489|OTHER|||||||0.0005|||||||Wilcoxon signed-rank test|Side Effects (Month 6): p-values for within treatment comparison from baseline||||||0.0005
72620714|NCT01633112|144772489|OTHER||||||<|0.0051|||||||Wilcoxon signed-rank test|Side Effects (Month 12): p-values for within treatment comparison from baseline||||||<0.0051
72620715|NCT01633112|144772489|OTHER||||||<|0.0001|||||||Wilcoxon signed-rank test|Side Effects (Month 12): p-values for within treatment comparison from baseline||||||<0.0001
72620716|NCT01633112|144772489|OTHER|||||||0.0051|||||||Wilcoxon signed-rank test|Side Effects (Month 12): p-values for within treatment comparison from baseline||||||0.0051
72456345|NCT02334215|144436161|SUPERIORITY|||||||0.11|||||||Generalized Linear Mixed Model Analysis|||Contrast of interest: Methadone plus Patient Navigation and Methadone Conditions combined vs. Enhanced Treatment as Usual||||0.11
72456346|NCT02334215|144436161|SUPERIORITY|||||||0.55|||||||Generalized Linear Mixed Model Analysis|||Contrast of interest: Methadone plus Patient Navigation vs. Methadone||||0.55
72456347|NCT02334215|144436162|SUPERIORITY|||||||0.55|||||||Regression, Logistic|||||||0.55
72456348|NCT02334215|144436162|SUPERIORITY|||||||0.57|||||||Regression, Logistic|||Contrast of interest: Methadone plus Patient Navigation vs Methadone||||0.57
72456349|NCT02334215|144436163|SUPERIORITY|||||||0.997|||||||Generalized Linear Mixed Model|||Contrast of interest: Methadone plus Patient Navigation and Methadone compared to Enhanced Treatment as Usual||||.997
72456350|NCT02334215|144436163|SUPERIORITY|||||||0.26|||||||Generalized Linear Mixed Model Analysis|||Contrast of interest: Methadone plus Patient Navigation vs Methadone||||0.26
72456351|NCT02334215|144436164|SUPERIORITY|Contrast of interest: Methadone plus Patient Navigation and Methadone compared to Enhanced Treatment as Usual||||||0.663|||||||Generalized Linear Mixed Model|||||||.663
72456352|NCT02334215|144436164|SUPERIORITY|||||||0.33|||||||Generalized Linear Mixed Model Analysis|||Contrast of interest: Methadone plus Patient Navigation vs Methadone||||0.33
72456353|NCT02334215|144436165|SUPERIORITY|||||||0.007|||||||Generalized Linear Mixed Model Analysis|||Contrast of interest: Methadone plus Patient Navigation and Methadone arms compared to Enhanced Treatment as Usual||||0.007
72456354|NCT02334215|144436165|SUPERIORITY|||||||0.76|||||||Generalized Linear Mixed Model Analysis|||Contrast of interest: Methadone plus Patient Navigation vs. Methadone||||.76
72620717|NCT01633112|144772489|OTHER||||||<|0.0001|||||||Wilcoxon signed-rank test|Convenience (Month 6): p-values for within treatment comparison from baseline||||||<0.0001
72620718|NCT01633112|144772489|OTHER||||||<|0.0001|||||||Wilcoxon signed-rank test|Convenience (Month 6): p-values for within treatment comparison from baseline||||||<0.0001
72456355|NCT02334215|144436166|SUPERIORITY|||||||0.6|||||||Generalized Linear Mixed Model Analysis|||Contrast of interest: Methadone plus Patient Navigation vs. Enhanced Treatment as Usual||||0.60
72456356|NCT02334215|144436166|SUPERIORITY|||||||1|||||||Generalized Linear Mixed Model Analysis|||Contrast of interest: Methadone plus Patient Navigation vs. Methadone||||1.0
72456357|NCT02334215|144436167|SUPERIORITY|||||||0.09|||||||Generalized Linear Mixed Model Analysis|||Contrast of interest: Methadone plus Patient Navigation and Methadone vs. Enhanced Treatment as Usual||||.09
72456358|NCT02334215|144436167|SUPERIORITY|||||||0.74|||||||Generalized Linear Mixed Model Analysis|||Contrast of interest: Methadone plus Patient Navigation vs. Methadone||||.74
72456359|NCT02334215|144436168|SUPERIORITY|||||||0.013|||||||Generalized Linear Mixed Model Analysis|||Contrast of interest: Methadone plus Patient Navigation and Methadone vs. Enhanced Treatment as Usual||||.013
72456360|NCT02334215|144436168|SUPERIORITY|||||||0.71|||||||Generalized Linear Mixed Model Analysis|||Contrast of interest: Methadone plus Patient Navigation vs. Methadone||||.71
72456361|NCT02334215|144436169|SUPERIORITY|Contrast of interest: Methadone plus Patient Navigation and Methadone vs. Enhanced Treatment as Usual||||||0.32|||||||Generalized Linear Mixed Model Analysis|||||||.32
72456362|NCT02334215|144436169|SUPERIORITY|||||||0.85|||||||Generalized Linear Mixed Model Analysis|||Contrast of interest: Methadone plus Patient Navigation vs. Methadone||||0.85
72620719|NCT01633112|144772489|OTHER|||||||0.0068|||||||Wilcoxon signed-rank test|Convenience (Month 6): p-values for within treatment comparison from baseline||||||0.0068
72620720|NCT01633112|144772489|OTHER||||||<|0.0001|||||||Wilcoxon signed-rank test|Convenience (Month 12): p-values for within treatment comparison from baseline||||||<0.0001
72620721|NCT01633112|144772489|OTHER||||||<|0.0001|||||||Wilcoxon signed-rank test|Convenience (Month 12): p-values for within treatment comparison from baseline||||||<0.0001
72620722|NCT01633112|144772489|OTHER|||||||0.4595|||||||Wilcoxon signed-rank test|Convenience (Month 12): p-values for within treatment comparison from baseline||||||0.4595
72620723|NCT01633112|144772490|OTHER|||||||0.1045|||||||ANCOVA|rank ANCOVA model adjusted for treatment, region, age, the number of relapses experienced in the previous year, and baseline normalized brain volume||||||0.1045
72620724|NCT01633112|144772490|OTHER|||||||0.1358|||||||ANCOVA|rank ANCOVA model adjusted for treatment, region, age, the number of relapses experienced in the previous year, and baseline normalized brain volume||||||0.1358
72456363|NCT02334215|144436170|SUPERIORITY|Contrast of interest: Methadone plus Patient Navigation and Methadone vs. Enhanced Treatment as Usual||||||0.1|||||||Generalized Linear Mixed Model Analysis|||||||.10
72456364|NCT02334215|144436170|SUPERIORITY|||||||0.74|||||||Generalized Linear Mixed Model Analysis|||Contrast of interest: Methadone plus Patient Navigation vs. Methadone||||.74
72456365|NCT02334215|144436171|SUPERIORITY|Contrast of interest: Methadone plus Patient Navigation and Methadone vs. Enhanced Treatment as Usual||||||0.42|||||||Generalized Linear Mixed Model Analysis|||||||.42
72456366|NCT02334215|144436171|SUPERIORITY|||||||0.42|||||||Generalized Linear Mixed Model Analysis|||Contrast of interest: Methadone plus Patient Navigation vs. Methadone||||0.42
72456367|NCT02334215|144436172|SUPERIORITY|Contrast of interest: Methadone plus Patient Navigation and Methadone vs. Enhanced Treatment as Usual||||||0.28|||||||Generalized Linear Mixed Model Analysis|||||||.28
72456368|NCT02334215|144436172|SUPERIORITY|||||||0.44|||||||Generalized Linear Mixed Model Analysis|||Contrast of interest: Methadone plus Patient Navigation vs. Methadone||||0.44
72456369|NCT02334215|144436173|SUPERIORITY|||||||0.61|||||||Generalized Linear Mixed Model Analysis|||Contrast of interest: Methadone plus Patient Navigation and Methadone combined vs. Enhanced Treatment as Usual||||.61
72456370|NCT02334215|144436173|SUPERIORITY|||||||0.72|||||||Generalized Linear Mixed Model Analysis|||Contrast of interest: Methadone plus Patient Navigation vs. Methadone||||0.72
72456371|NCT02334215|144436174|SUPERIORITY|Contrast of interest: Methadone plus Patient Navigation and Methadone vs. Enhanced Treatment as Usual||||||0.71|||||||Generalized Linear Mixed Model Analysis|||||||.71
72456372|NCT02334215|144436174|SUPERIORITY|||||||0.86|||||||Generalized Linear Mixed Model Analysis|||Contrast of interest: Methadone plus Patient Navigation vs. Methadone||||.86
72456373|NCT03769090|144436186|SUPERIORITY||Hazard Ratio (HR)|0.733|||<|0.001|TWO_SIDED|95.0|0.611|0.879|||Regression, Cox|||H0 = null hypothesis. Hazard ratios, 95% confidence intervals for hazard ratios and p-values are estimated using a Cox regression model with treatment group, age group, region and number of severe exacerbations in the last 12 months prior to randomization as factors. A hazard ratio less than 1 favours BDA MDI treatment.||0.879|0.611|<0.001
72456374|NCT03769090|144436186|SUPERIORITY||Hazard Ratio (HR)|0.835||||0.041|TWO_SIDED|95.0|0.702|0.992|||Regression, Cox|||H0 = Null hypothesis. Hazard ratios, 95% confidence intervals for hazard ratios and p-values are estimated using a Cox regression model with treatment group, age group, region and number of severe exacerbations in the last 12 months prior to randomization as factors. A hazard ratio less than 1 favours BDI MDI treatment.||0.992|0.702|0.041
72456375|NCT03769090|144436187|SUPERIORITY||Rate Ratio|0.76||||0.008|TWO_SIDED|95.0|0.62|0.93|||Negative binomial model|||Estimated from a negative binomial model with treatment, age group, region, and number of severe exacerbations in the last 12 months prior to randomization as categorical covariates. The logarithm of the time at risk is included as an offset variable. A sequential testing strategy is used for secondary endpoints. A null hypothesis can only be rejected if all preceding null hypotheses are also rejected.||0.93|0.62|0.008
72456376|NCT03769090|144436187|SUPERIORITY||Rate Ratio|0.8||||0.028|TWO_SIDED|95.0|0.66|0.98|||Negative binomial model|||Estimated from a negative binomial model with treatment, age group, region, and number of severe exacerbations in the last 12 months prior to randomization as categorical covariates. The logarithm of the time at risk is included as an offset variable. A sequential testing strategy is used for secondary endpoints. A null hypothesis can only be rejected if all preceding null hypotheses are also rejected.||0.98|0.66|0.028
72456377|NCT03769090|144436188|SUPERIORITY|||||||0.002|||||||Wilcoxon rank sum|||P-values are calculated via a Wilcoxon rank sum test. A sequential testing strategy is used for secondary endpoints. A null hypothesis can only be rejected if all preceding null hypotheses are also rejected.||||0.002
72456378|NCT03769090|144436188|SUPERIORITY|||||||0.06|||||||Wilcoxon rank sum|||P-values are calculated via a Wilcoxon rank sum test. A sequential testing strategy is used for secondary endpoints. A null hypothesis can only be rejected if all preceding null hypotheses are also rejected.||||0.06
72456379|NCT03769090|144436189|SUPERIORITY||Odds Ratio (OR)|1.221||||0.033|TWO_SIDED|95.0|1.016|1.467|||Regression, Logistic|||Logistic regression model with baseline ACQ-5 as a continuous covariate and age group, region and number of severe exacerbations in the 12 months prior to randomization as categorical covariates. A sequential testing strategy is used for secondary endpoints. A null hypothesis can only be rejected if all preceding null hypotheses are also rejected.||1.467|1.016|0.033
72456380|NCT03769090|144436189|SUPERIORITY||Odds Ratio (OR)|1.132||||0.175|TWO_SIDED|95.0|0.946|1.353|||Regression, Logistic|||Logistic regression model with baseline ACQ-5 as a continuous covariate and age group, region and number of severe exacerbations in the 12 months prior to randomization as categorical covariates. A sequential testing strategy is used for secondary endpoints. A null hypothesis can only be rejected if all preceding null hypotheses are also rejected.||1.353|0.946|0.175
72500184|NCT02537678|144530734|NON_INFERIORITY|We planned 0.41standard deviation as the non-inferiority margin (which is less than half of the effect size) for the one-side testing. Non-inferiority analysis with alpha 2.5% was applied 12-month assessment.|Mean Difference (Final Values)|-0.13|STANDARD_ERROR_OF_MEAN|1.2||0.001|ONE_SIDED|97.5|-2.5||||t-test, 1 sided|||Based on the actual randomization of 183 participants (SC-TF-CBT=91; standard TF-CBT=92), we had more than 80% power to show that SC-TF-CBT is at least as effective as standard TF-CBT with alpha of .05 and a non-inferior margin of 0.41 standard deviation units.|Treatment difference = standard TF-CBT - stepped care TF-CBT||-2.50|.001
72500185|NCT02537678|144530735|NON_INFERIORITY|We planned 0.41 standard deviation as the non-inferiority margin (which is less than half of the effect size) for the one-side testing. Non-inferiority analysis with alpha 2.5% was applied at post assessment.|Mean Difference (Final Values)|0.79|STANDARD_ERROR_OF_MEAN|1.89|<|0.001|ONE_SIDED|97.5|-2.94||||t-test, 1 sided|||Based on the actual randomization of 183 participants (SC-TF-CBT=91; standard TF-CBT=92), we had more than 80% power to show that SC-TF-CBT is at least as effective as standard TF-CBT with alpha of .05 and a non-inferior margin of 0.41 standard deviation units.|Treatment difference = standard TF-CBT - stepped care TF-CBT||-2.94|<0.001
72620725|NCT01959919|144772491|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.907||||0|||||||Wilcoxon Signed Ranks Test|||Comparison between ease of using clotting factor treatment score at Final visit (Month 8) and baseline visit||||0.000
72620726|NCT01959919|144772492|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.572|STANDARD_ERROR_OF_MEAN|0.584||0|TWO_SIDED|95.0|3.411|5.733|||t-test, 2 sided|||Comparison between time for reconstructing the drug at Final visit (Month 8) and baseline visit||5.733|3.411|0.000
72620727|NCT01959919|144772493|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-3.789||||0|||||||Wilcoxon Signed Ranks Test|||Comparison between burden of clotting factor treatment score at Final Visit Month 8 and baseline visit||||0.000
72620728|NCT01959919|144772494|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-3.98||||0|||||||Wilcoxon Signed Ranks Test|||Comparison between impact of clotting factor treatment score at Final Visit Month 8 and baseline visit||||0.000
72620729|NCT01959919|144772495|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-3.445||||0.001|||||||Wilcoxon Signed Ranks Test|||Comparison between risk associated with clotting factor treatment score at Final Visit Month 8 and baseline visit||||0.001
72456381|NCT03769090|144436190|SUPERIORITY||Odds Ratio (OR)|1.228||||0.028|TWO_SIDED|95.0|1.022|1.475|||Regression, Logistic|||Logistic regression model with baseline AQLQ-12 as a continuous covariate and age group, region and number of severe exacerbations in the 12 months prior to randomization as categorical covariates. A sequential testing strategy is used for secondary endpoints. A null hypothesis can only be rejected if all preceding null hypotheses are also rejected.||1.475|1.022|0.028
72456382|NCT03769090|144436190|SUPERIORITY||Odds Ratio (OR)|1.111||||0.26|TWO_SIDED|95.0|0.925|1.335|||Regression, Logistic|||Logistic regression model with baseline AQLQ-12 as a continuous covariate and age group, region and number of severe exacerbations in the 12 months prior to randomization as categorical covariates. A sequential testing strategy is used for secondary endpoints. A null hypothesis can only be rejected if all preceding null hypotheses are also rejected.||1.335|0.925|0.26
72456383|NCT01190124|144436206|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Chi-squared|||Comparison between the 3 study groups, in order to determine if there are statistically significant differences concerning HIV-RNA levels at baseline||||<0.001
72456384|NCT01190124|144436209|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Kruskal-Wallis|||Comparison between the 3 study groups, in order to determine if there are statistically significant differences concerning CD4 cells count at baseline||||<0.001
72620730|NCT01697501|144772504|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.86||||0.7831|TWO_SIDED|95.0|0.29|2.57|||univariate logistic analysis|||||2.57|0.29|0.7831
72620731|NCT01697501|144772505|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.25||||0.1951|TWO_SIDED|95.0|0.66|7.67|||univariate logistic analysis|||||7.67|0.66|0.1951
72620732|NCT01697501|144772506|SUPERIORITY_OR_OTHER|||||||0.2642|TWO_SIDED||||||Wald Chi Square|||||||0.2642
72620733|NCT01697501|144772507|SUPERIORITY_OR_OTHER|||||||0.0672|TWO_SIDED||||||Wald Chi Square|||||||0.0672
72456385|NCT01190124|144436222|SUPERIORITY_OR_OTHER|||||||0.007|||||||Kruskal-Wallis|||Comparison between the 3 study groups, in order to determine if there are statistically significant differences concerning CD4 cells count at week 24||||0.007
72456386|NCT01190124|144436223|SUPERIORITY_OR_OTHER|||||||0.001|||||||Kruskal-Wallis|||Comparison between the 3 study groups, in order to determine if there are statistically significant differences concerning CD4 cells count at week 48||||0.001
72456387|NCT00070707|144436242|SUPERIORITY_OR_OTHER_LEGACY|||||||0.101|||||||ANOVA|||Baseline (AM)||||0.101
72456388|NCT00070707|144436242|SUPERIORITY_OR_OTHER_LEGACY|||||||0.168|||||||ANOVA|||Change at Week 1 (AM)||||0.168
72500186|NCT02537678|144530736|NON_INFERIORITY|We planned 0.41 standard deviation as the non-inferiority margin (which is less than half of the effect size) for the one-side testing. Non-inferiority analysis with alpha 2.5% was applied at 6-month assessment.|Mean Difference (Final Values)|-1.89|STANDARD_ERROR_OF_MEAN|2.25||0.044|ONE_SIDED|97.5|-6.33||||t-test, 1 sided|||Based on the actual randomization of 183 participants (SC-TF-CBT=91; standard TF-CBT=92), we had more than 80% power to show that SC-TF-CBT is at least as effective as standard TF-CBT with alpha of .05 and a non-inferior margin of 0.41 standard deviation units.|Treatment difference = standard TF-CBT - stepped care TF-CBT||-6.33|.044
72620734|NCT03992872|144772526|SUPERIORITY|The significance of the difference between groups in seroconversion rates was assessed using a Fisher's exact test. The percentage who seroconverted in each group was presented along with its 95% CI calculated using the Wilson method. The Newcombe method was use to estimate the 95% confidence interval for the difference between groups in the percentage of subjects who seroconverted.|Mean Difference (Final Values)|0.0||||1|TWO_SIDED|95.0|-11.4|11.4|||Fisher Exact|||||11.4|-11.4|1
72456389|NCT00070707|144436242|SUPERIORITY_OR_OTHER_LEGACY|||||||0.93|||||||ANOVA|||Change at Week 2 (AM)||||0.930
72456390|NCT00070707|144436242|SUPERIORITY_OR_OTHER_LEGACY|||||||0.487|||||||ANOVA|||Change at Week 3 (AM)||||0.487
72456391|NCT00070707|144436242|SUPERIORITY_OR_OTHER_LEGACY|||||||0.914|||||||ANOVA|||Change at Week 4 (AM)||||0.914
72456392|NCT00070707|144436242|SUPERIORITY_OR_OTHER_LEGACY|||||||0.977|||||||ANOVA|||Change at Final Week (AM)||||0.977
72456393|NCT00070707|144436242|SUPERIORITY_OR_OTHER_LEGACY|||||||0.109|||||||ANOVA|||Baseline (PM)||||0.109
72456394|NCT00070707|144436242|SUPERIORITY_OR_OTHER_LEGACY|||||||0.291|||||||ANOVA|||Change at Week 1 (PM)||||0.291
72620735|NCT03992872|144772527|SUPERIORITY||GMR (Prior Alpha / Naïve Alpha)|1.2|||||TWO_SIDED|95.0||||P- value = NE (Not estimable due to lack of response; all baseline values in this group were \<LOD and imputed as LOD/2, or 7.5)||P-values were based on an ANOVA model with log10-transformed titer as the dependent variable and study arm, age, and gender as predictors.|"Differences in least squares means from the ANOVA model were back-transformed and reported as geometric mean ratios with 95% confidence intervals.~95% CI \[NE,NE\]~NE = Not estimable due to lack of response."|Day 1: Geometric mean ratio (prior alpha group over naïve alpha group) and 95% confidence interval||||
72620736|NCT03992872|144772527|SUPERIORITY||GMR (Prior Alpha / Naïve Alpha)|3.11||||0.0019|TWO_SIDED|95.0|1.55|6.23|||ANOVA|P-values were based on an ANOVA model with log10-transformed titer as the dependent variable and study arm, age, and gender as predictors.|Differences in least squares means from the ANOVA model were back-transformed and reported as geometric mean ratios with 95% confidence intervals.|Day 8: Geometric mean ratio (prior alpha group over naïve alpha group) and 95% confidence interval||6.23|1.55|0.0019
72456395|NCT00070707|144436242|SUPERIORITY_OR_OTHER_LEGACY|||||||0.984|||||||ANOVA|||Change at Week 2 (PM)||||0.984
72456396|NCT00070707|144436242|SUPERIORITY_OR_OTHER_LEGACY|||||||0.373|||||||ANOVA|||Change at Week 3 (PM)||||0.373
72456397|NCT00070707|144436242|SUPERIORITY_OR_OTHER_LEGACY|||||||0.623|||||||ANOVA|||Change at Week 4 (PM)||||0.623
72622505|NCT03941093|144774998|OTHER||Hazard Ratio (HR)|1.08||||0.5487|TWO_SIDED|95.0|0.83|1.41|||Stratified Log Rank Test|||||1.41|0.83|0.5487
72456398|NCT00070707|144436242|SUPERIORITY_OR_OTHER_LEGACY|||||||0.978|||||||ANOVA|||Change at Final Week (PM)||||0.978
72456399|NCT00070707|144436243|SUPERIORITY_OR_OTHER_LEGACY|||||||0.023|||||||ANOVA|||Baseline (AM)||||0.023
72456400|NCT00070707|144436243|SUPERIORITY_OR_OTHER_LEGACY|||||||0.693|||||||ANOVA|||Change at Week 1 (AM)||||0.693
72456401|NCT00070707|144436243|SUPERIORITY_OR_OTHER_LEGACY|||||||0.483|||||||ANOVA|||Change at Week 2 (AM)||||0.483
72456402|NCT00070707|144436243|SUPERIORITY_OR_OTHER_LEGACY|||||||0.088|||||||ANOVA|||Change at Week 3 (AM)||||0.088
72456403|NCT00070707|144436243|SUPERIORITY_OR_OTHER_LEGACY|||||||0.21|||||||ANOVA|||Change at Week 4 (AM)||||0.210
72456404|NCT00070707|144436243|SUPERIORITY_OR_OTHER_LEGACY|||||||0.178|||||||ANOVA|||Change at Final Week (AM)||||0.178
72456405|NCT00070707|144436243|SUPERIORITY_OR_OTHER_LEGACY|||||||0.055|||||||ANOVA|||Baseline (PM)||||0.055
72456406|NCT00070707|144436243|SUPERIORITY_OR_OTHER_LEGACY|||||||0.915|||||||ANOVA|||Change at Week 1 (PM)||||0.915
72456407|NCT00070707|144436243|SUPERIORITY_OR_OTHER_LEGACY|||||||0.471|||||||ANOVA|||Change at Week 2 (PM)||||0.471
72456408|NCT00070707|144436243|SUPERIORITY_OR_OTHER_LEGACY|||||||0.11|||||||ANOVA|||Change at Week 3 (PM)||||0.110
72456409|NCT00070707|144436243|SUPERIORITY_OR_OTHER_LEGACY|||||||0.305|||||||ANOVA|||Change at Week 4 (PM)||||0.305
72456410|NCT00070707|144436243|SUPERIORITY_OR_OTHER_LEGACY|||||||0.461|||||||ANOVA|||Change at Final Week (PM)||||0.461
72456411|NCT00070707|144436244|SUPERIORITY_OR_OTHER_LEGACY|||||||0.068|||||||ANOVA|||Baseline (AM)||||0.068
72456412|NCT00070707|144436244|SUPERIORITY_OR_OTHER_LEGACY|||||||0.116|||||||ANOVA|||Change at Week 1 (AM)||||0.116
72456413|NCT00070707|144436244|SUPERIORITY_OR_OTHER_LEGACY|||||||0.749|||||||ANOVA|||Change at Week 2 (AM)||||0.749
72456414|NCT00070707|144436244|SUPERIORITY_OR_OTHER_LEGACY|||||||0.289|||||||ANOVA|||Change at Week 3 (AM)||||0.289
72456415|NCT00070707|144436244|SUPERIORITY_OR_OTHER_LEGACY|||||||0.982|||||||ANOVA|||Change at Week 4 (AM)||||0.982
72456416|NCT00070707|144436244|SUPERIORITY_OR_OTHER_LEGACY|||||||0.941|||||||ANOVA|||Change at Final Week (AM)||||0.941
72456417|NCT00070707|144436244|SUPERIORITY_OR_OTHER_LEGACY|||||||0.128|||||||ANOVA|||Baseline (PM)||||0.128
72456418|NCT00070707|144436244|SUPERIORITY_OR_OTHER_LEGACY|||||||0.484|||||||ANOVA|||Change at Week 1 (PM)||||0.484
72456419|NCT00070707|144436244|SUPERIORITY_OR_OTHER_LEGACY|||||||0.673|||||||ANOVA|||Change at Week 2 (PM)||||0.673
72456420|NCT00070707|144436244|SUPERIORITY_OR_OTHER_LEGACY|||||||0.25|||||||ANOVA|||Change at Week 3 (PM)||||0.250
72456421|NCT00070707|144436244|SUPERIORITY_OR_OTHER_LEGACY|||||||0.45|||||||ANOVA|||Change at Week 4 (PM)||||0.450
72456422|NCT00070707|144436244|SUPERIORITY_OR_OTHER_LEGACY|||||||0.774|||||||ANOVA|||Change at Final Week (PM)||||0.774
72620737|NCT03992872|144772527|SUPERIORITY||GMR (Prior Alpha / Naïve Alpha)|0.88||||0.6223|TWO_SIDED|95.0|0.54|1.46|||ANOVA|P-values were based on an ANOVA model with log10-transformed titer as the dependent variable and study arm, age, and gender as predictors.|Differences in least squares means from the ANOVA model were back-transformed and reported as geometric mean ratios with 95% confidence intervals.|Day 22: Geometric mean ratio (prior alpha group over naïve alpha group) and 95% confidence interval||1.46|0.54|0.6223
72456423|NCT00070707|144436245|SUPERIORITY_OR_OTHER_LEGACY|||||||0.078|||||||ANOVA|||Baseline (AM)||||0.078
72456424|NCT00070707|144436245|SUPERIORITY_OR_OTHER_LEGACY|||||||0.492|||||||ANOVA|||Change at Week 1 (AM)||||0.492
72456425|NCT00070707|144436245|SUPERIORITY_OR_OTHER_LEGACY|||||||0.945|||||||ANOVA|||Change at Week 2 (AM)||||0.945
72456426|NCT00070707|144436245|SUPERIORITY_OR_OTHER_LEGACY|||||||0.359|||||||ANOVA|||Change at Week 3 (AM)||||0.359
72456427|NCT00070707|144436245|SUPERIORITY_OR_OTHER_LEGACY|||||||0.802|||||||ANOVA|||Change at Week 4 (AM)||||0.802
72456428|NCT00070707|144436245|SUPERIORITY_OR_OTHER_LEGACY|||||||0.716|||||||ANOVA|||Change at Final Week (AM)||||0.716
72456429|NCT00070707|144436245|SUPERIORITY_OR_OTHER_LEGACY|||||||0.158|||||||ANOVA|||Baseline (PM)||||0.158
72456430|NCT00070707|144436245|SUPERIORITY_OR_OTHER_LEGACY|||||||0.281|||||||ANOVA|||Change at Week 1 (PM)||||0.281
72456431|NCT00070707|144436245|SUPERIORITY_OR_OTHER_LEGACY|||||||0.901|||||||ANOVA|||Change at Week 2 (PM)||||0.901
72456432|NCT00070707|144436245|SUPERIORITY_OR_OTHER_LEGACY|||||||0.433|||||||ANOVA|||Change at Week 3 (PM)||||0.433
72456433|NCT00070707|144436245|SUPERIORITY_OR_OTHER_LEGACY|||||||0.73|||||||ANOVA|||Change at Week 4 (PM)||||0.730
72456434|NCT00070707|144436245|SUPERIORITY_OR_OTHER_LEGACY|||||||0.819|||||||ANOVA|||Change at Final Week (PM)||||0.819
72456435|NCT00070707|144436246|SUPERIORITY_OR_OTHER_LEGACY|||||||0.629|||||||ANOVA|||Baseline (AM)||||0.629
72456436|NCT00070707|144436246|SUPERIORITY_OR_OTHER_LEGACY|||||||0.038|||||||ANOVA|||Change at Week 1 (AM)||||0.038
72456437|NCT00070707|144436246|SUPERIORITY_OR_OTHER_LEGACY|||||||0.182|||||||ANOVA|||Change at Week 2 (AM)||||0.182
72456438|NCT00070707|144436246|SUPERIORITY_OR_OTHER_LEGACY|||||||0.149|||||||ANOVA|||Change at Week 3 (AM)||||0.149
72456439|NCT00070707|144436246|SUPERIORITY_OR_OTHER_LEGACY|||||||0.035|||||||ANOVA|||Change at Week 4 (AM)||||0.035
72456440|NCT00070707|144436246|SUPERIORITY_OR_OTHER_LEGACY|||||||0.056|||||||ANOVA|||Change at Final Week (AM)||||0.056
72456441|NCT00070707|144436246|SUPERIORITY_OR_OTHER_LEGACY|||||||0.711|||||||ANOVA|||Baseline (PM)||||0.711
72456442|NCT00070707|144436246|SUPERIORITY_OR_OTHER_LEGACY|||||||0.098|||||||ANOVA|||Change at Week 1 (PM)||||0.098
72456443|NCT00070707|144436246|SUPERIORITY_OR_OTHER_LEGACY|||||||0.356|||||||ANOVA|||Change at Week 2 (PM)||||0.356
72456444|NCT00070707|144436246|SUPERIORITY_OR_OTHER_LEGACY|||||||0.529|||||||ANOVA|||Change at Week 3 (PM)||||0.529
72456445|NCT00070707|144436246|SUPERIORITY_OR_OTHER_LEGACY|||||||0.617|||||||ANOVA|||Change at Week 4 (PM)||||0.617
72456446|NCT00070707|144436246|SUPERIORITY_OR_OTHER_LEGACY|||||||0.422|||||||ANOVA|||Change at Final Week (PM)||||0.422
72456447|NCT00070707|144436247|SUPERIORITY_OR_OTHER_LEGACY|Baseline||||||0.532|||||||Cochran-Mantel-Haenszel|||||||0.532
72456448|NCT00070707|144436247|SUPERIORITY_OR_OTHER_LEGACY|Day 15||||||0.739|||||||Cochran-Mantel-Haenszel|||||||0.739
72456449|NCT00070707|144436247|SUPERIORITY_OR_OTHER_LEGACY|Day 29||||||0.227|||||||Cochran-Mantel-Haenszel|||||||0.227
72456450|NCT00070707|144436248|SUPERIORITY_OR_OTHER_LEGACY|||||||0.104|||||||ANOVA|||Baseline (AM)||||0.104
72456451|NCT00070707|144436248|SUPERIORITY_OR_OTHER_LEGACY|||||||0.022|||||||ANOVA|||Change at Week 1 (AM)||||0.022
72456452|NCT00070707|144436248|SUPERIORITY_OR_OTHER_LEGACY|||||||0.012|||||||ANOVA|||Change at Week 2 (AM)||||0.012
72456453|NCT00070707|144436248|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|||||||ANOVA|||Change at Week 3 (AM)||||0.001
72456454|NCT00070707|144436248|SUPERIORITY_OR_OTHER_LEGACY|||||||0.033|||||||ANOVA|||Change at Week 4 (AM)||||0.033
72456455|NCT00070707|144436248|SUPERIORITY_OR_OTHER_LEGACY|||||||0.047|||||||ANOVA|||Change at Final Week (AM)||||0.047
72456456|NCT00070707|144436248|SUPERIORITY_OR_OTHER_LEGACY|||||||0.269|||||||ANOVA|||Baseline (PM)||||0.269
72456457|NCT00070707|144436248|SUPERIORITY_OR_OTHER_LEGACY|||||||0.308|||||||ANOVA|||Change at Week 1 (PM)||||0.308
72456458|NCT00070707|144436248|SUPERIORITY_OR_OTHER_LEGACY|||||||0.05|||||||ANOVA|||Change at Week 2 (PM)||||0.050
72456459|NCT00070707|144436248|SUPERIORITY_OR_OTHER_LEGACY|||||||0.014|||||||ANOVA|||Change at Week 3 (PM)||||0.014
72456460|NCT00070707|144436248|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1|||||||ANOVA|||Change at Week 4 (PM)||||0.100
72456461|NCT00070707|144436248|SUPERIORITY_OR_OTHER_LEGACY|||||||0.139|||||||ANOVA|||Change at Final Week (PM)||||0.139
72456462|NCT00070707|144436249|SUPERIORITY_OR_OTHER_LEGACY|||||||0.136|||||||ANOVA|||Baseline (AM)||||0.136
72456463|NCT00070707|144436249|SUPERIORITY_OR_OTHER_LEGACY|||||||0.126|||||||ANOVA|||Change at Week 1 (AM)||||0.126
72456464|NCT00070707|144436249|SUPERIORITY_OR_OTHER_LEGACY|||||||0.107|||||||ANOVA|||Change at Week 2 (AM)||||0.107
72456465|NCT00070707|144436249|SUPERIORITY_OR_OTHER_LEGACY|||||||0.006|||||||ANOVA|||Change at Week 3 (AM)||||0.006
72456466|NCT00070707|144436249|SUPERIORITY_OR_OTHER_LEGACY|||||||0.03|||||||ANOVA|||Change at Week 4 (AM)||||0.030
72456467|NCT00070707|144436249|SUPERIORITY_OR_OTHER_LEGACY|||||||0.037|||||||ANOVA|||Change at Final Week (AM)||||0.037
72456468|NCT00070707|144436249|SUPERIORITY_OR_OTHER_LEGACY|||||||0.146|||||||ANOVA|||Baseline (PM)||||0.146
72456469|NCT00070707|144436249|SUPERIORITY_OR_OTHER_LEGACY|||||||0.426|||||||ANOVA|||Change at Week 1 (PM)||||0.426
72500187|NCT02537678|144530737|NON_INFERIORITY|We planned 0.41 standard deviation as the non-inferiority margin (which is less than half of the effect size) for the one-side testing. Non-inferiority analysis with alpha 2.5% was applied at 12-month assessment.|Mean Difference (Final Values)|0.38|STANDARD_ERROR_OF_MEAN|1.75||0.002|ONE_SIDED|97.5|-3.07||||t-test, 1 sided|||Based on the actual randomization of 183 participants (SC-TF-CBT=91; standard TF-CBT=92), we had more than 80% power to show that SC-TF-CBT is at least as effective as standard TF-CBT with alpha of .05 and a non-inferior margin of 0.41 standard deviation units.|Treatment difference = standard TF-CBT - stepped care TF-CBT||-3.07|0.002
72500188|NCT02537678|144530738|NON_INFERIORITY|We planned 0.41 standard deviation (SD) as the non-inferiority margin (which is less than half of the effect size) for the one-side testing. Non-inferiority analysis with alpha 2.5% was applied at post assessment.|Mean Difference (Final Values)|-1.06|STANDARD_ERROR_OF_MEAN|1.52||0.016|ONE_SIDED|97.5|-4.06||||t-test, 1 sided||||Treatment difference = standard TF-CBT - stepped care TF-CBT||-4.06|0.016
72500189|NCT02537678|144530739|NON_INFERIORITY|We planned 0.41 standard deviation as the non-inferiority margin (which is less than half of the effect size) for the one-side testing. Non-inferiority analysis with alpha 2.5% was applied at 6-month assessment.|Mean Difference (Final Values)|-0.23|STANDARD_ERROR_OF_MEAN|1.77||0.003|ONE_SIDED|97.5|-3.72||||t-test, 1 sided|||Based on the actual randomization of 183 participants (SC-TF-CBT=91; standard TF-CBT=92), we had more than 80% power to show that SC-TF-CBT is at least as effective as standard TF-CBT with alpha of .05 and a non-inferior margin of 0.41 standard deviation units.|Treatment difference = standard TF-CBT - stepped care TF-CBT||-3.72|0.003
72500190|NCT02537678|144530740|NON_INFERIORITY|We planned 0.41 standard deviation the non-inferiority margin (which is less than half of the effect size) for the one-side testing. Non-inferiority analysis with alpha 2.5% was applied at 12-month assessment.|Mean Difference (Final Values)|-0.16|STANDARD_ERROR_OF_MEAN|1.89||0.007|ONE_SIDED|97.5|-3.89||||t-test, 1 sided||||Treatment difference = standard TF-CBT - stepped care TF-CBT||-3.89|0.007
72500191|NCT02537678|144530741|NON_INFERIORITY|We planned 0.41 standard deviation as the non-inferiority margin (which is less than half of the effect size) for the one-side testing. Non-inferiority analysis with alpha 2.5% was applied at post assessment.|Mean Difference (Final Values)|-1.01|STANDARD_ERROR_OF_MEAN|1.64||0.008|ONE_SIDED|97.5|-4.24||||t-test, 1 sided||||Treatment difference = standard TF-CBT - stepped care TF-CBT||-4.24|0.008
72500192|NCT02537678|144530742|NON_INFERIORITY|We planned 0.41 standard deviation as the non-inferiority margin (which is less than half of the effect size) for the one-side testing. Non-inferiority analysis with alpha 2.5% was applied at 6-month assessment.|Mean Difference (Final Values)|-1.36|STANDARD_ERROR_OF_MEAN|1.78||0.015|ONE_SIDED|97.5|-4.88||||t-test, 1 sided||||Treatment difference = standard TF-CBT - stepped care TF-CBT||-4.88|0.015
72500193|NCT02537678|144530743|NON_INFERIORITY|We planned 0.41 standard deviation as the non-inferiority margin (which is less than half of the effect size) for the one-side testing. Non-inferiority analysis with alpha 2.5% was applied at 12-month assessment.|Mean Difference (Final Values)|-1.75|STANDARD_ERROR_OF_MEAN|1.99||0.024|ONE_SIDED|97.5|-5.68||||t-test, 1 sided||||Treatment difference = standard TF-CBT - stepped care TF-CBT||-5.68|0.024
72620738|NCT03992872|144772527|SUPERIORITY||GMR (Prior Alpha / Naïve Alpha)|0.88||||0.6444|TWO_SIDED|95.0|0.5|1.55||P-values were based on an ANOVA model with log10-transformed titer as the dependent variable and study arm, age, and gender as predictors.|ANOVA||Differences in least squares means from the ANOVA model were back-transformed and reported as geometric mean ratios with 95% confidence intervals.|Day 29: Geometric mean ratio (prior alpha group over naïve alpha group) and 95% confidence interval||1.55|0.50|0.6444
72456470|NCT00070707|144436249|SUPERIORITY_OR_OTHER_LEGACY|||||||0.259|||||||ANOVA|||Change at Week 2 (PM)||||0.259
72456471|NCT00070707|144436249|SUPERIORITY_OR_OTHER_LEGACY|||||||0.026|||||||ANOVA|||Change at Week 3 (PM)||||0.026
72456472|NCT00070707|144436249|SUPERIORITY_OR_OTHER_LEGACY|||||||0.022|||||||ANOVA|||Change at Week 4 (PM)||||0.022
72456473|NCT00070707|144436249|SUPERIORITY_OR_OTHER_LEGACY|||||||0.043|||||||ANOVA|||Change at Final Week (PM)||||0.043
72456474|NCT00070707|144436250|SUPERIORITY_OR_OTHER_LEGACY|||||||0.181|||||||ANOVA|||Baseline (AM)||||0.181
72456475|NCT00070707|144436250|SUPERIORITY_OR_OTHER_LEGACY|||||||0.014|||||||ANOVA|||Change at Week 1 (AM)||||0.014
72456476|NCT00070707|144436250|SUPERIORITY_OR_OTHER_LEGACY|||||||0.004|||||||ANOVA|||Change at Week 2 (AM)||||0.004
72456477|NCT00070707|144436250|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002|||||||ANOVA|||Change at Week 3 (AM)||||0.002
72456478|NCT00070707|144436250|SUPERIORITY_OR_OTHER_LEGACY|||||||0.027|||||||ANOVA|||Change at Week 4 (AM)||||0.027
72456479|NCT00070707|144436250|SUPERIORITY_OR_OTHER_LEGACY|||||||0.069|||||||ANOVA|||Change at Final Week (AM)||||0.069
72456480|NCT00070707|144436250|SUPERIORITY_OR_OTHER_LEGACY|||||||0.373|||||||ANOVA|||Baseline (PM)||||0.373
72456481|NCT00070707|144436250|SUPERIORITY_OR_OTHER_LEGACY|||||||0.148|||||||ANOVA|||Change at Week 1 (PM)||||0.148
72456482|NCT00070707|144436250|SUPERIORITY_OR_OTHER_LEGACY|||||||0.009|||||||ANOVA|||Change at Week 2 (PM)||||0.009
72456483|NCT00070707|144436250|SUPERIORITY_OR_OTHER_LEGACY|||||||0.016|||||||ANOVA|||Change at Week 3 (PM)||||0.016
72456484|NCT00070707|144436250|SUPERIORITY_OR_OTHER_LEGACY|||||||0.113|||||||ANOVA|||Change at Week 4 (PM)||||0.113
72456485|NCT00070707|144436250|SUPERIORITY_OR_OTHER_LEGACY|||||||0.173|||||||ANOVA|||Change at Final Week (PM)||||0.173
72456486|NCT00070707|144436251|SUPERIORITY_OR_OTHER_LEGACY|||||||0.089|||||||ANOVA|||Baseline (AM)||||0.089
72456487|NCT00070707|144436251|SUPERIORITY_OR_OTHER_LEGACY|||||||0.014|||||||ANOVA|||Change at Week 1 (AM)||||0.014
72456488|NCT00070707|144436251|SUPERIORITY_OR_OTHER_LEGACY|||||||0.004|||||||ANOVA|||Change at Week 2 (AM)||||0.004
72456489|NCT00070707|144436251|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|||||||ANOVA|||Change at Week 3 (AM)||||0.001
72456490|NCT00070707|144436251|SUPERIORITY_OR_OTHER_LEGACY|||||||0.041|||||||ANOVA|||Change at Week 4 (AM)||||0.041
72456491|NCT00070707|144436251|SUPERIORITY_OR_OTHER_LEGACY|||||||0.036|||||||ANOVA|||Change at Final Week (AM)||||0.036
72620739|NCT03992872|144772527|SUPERIORITY||GMR (Prior Alpha / Naïve Alpha)|0.89||||0.6198|TWO_SIDED|95.0|0.57|1.41||P-values were based on an ANOVA model with log10-transformed titer as the dependent variable and study arm, age, and gender as predictors.|ANOVA||Differences in least squares means from the ANOVA model were back-transformed and reported as geometric mean ratios with 95% confidence intervals.|Day 57: Geometric mean ratio (prior alpha group over naïve alpha group) and 95% confidence interval||1.41|0.57|0.6198
72456492|NCT00070707|144436251|SUPERIORITY_OR_OTHER_LEGACY|||||||0.17|||||||ANOVA|||Baseline (PM)||||0.170
72456493|NCT00070707|144436251|SUPERIORITY_OR_OTHER_LEGACY|||||||0.237|||||||ANOVA|||Change at Week 1 (PM)||||0.237
72456494|NCT00070707|144436251|SUPERIORITY_OR_OTHER_LEGACY|||||||0.019|||||||ANOVA|||Change at Week 2 (PM)||||0.019
72456495|NCT00070707|144436251|SUPERIORITY_OR_OTHER_LEGACY|||||||0.018|||||||ANOVA|||Change at Week 3 (PM)||||0.018
72456496|NCT00070707|144436251|SUPERIORITY_OR_OTHER_LEGACY|||||||0.149|||||||ANOVA|||Change at Week 4 (PM)||||0.149
72620740|NCT03992872|144772527|SUPERIORITY||GMR (Prior Alpha / Naïve Alpha)|0.89||||0.6451|TWO_SIDED|95.0|0.55|1.45||P-values were based on an ANOVA model with log10-transformed titer as the dependent variable and study arm, age, and gender as predictors.|ANOVA||Differences in least squares means from the ANOVA model were back-transformed and reported as geometric mean ratios with 95% confidence intervals.|Day 182: Geometric mean ratio (prior alpha group over naïve alpha group) and 95% confidence interval||1.45|0.55|0.6451
72620741|NCT03992872|144772528|SUPERIORITY|||||||0.0211|||||||Fisher Exact|"Day 8~Note: A subject has a 4-fold rise at a visit if they achieve a titer at that visit that is at least 4-fold higher than their Day 1 titer."||||||0.0211
72620742|NCT03992872|144772528|SUPERIORITY|||||||1|||||||Fisher Exact|"Day 29.~Note: A subject has a 4-fold rise at a visit if they achieve a titer at that visit that is at least 4-fold higher than their Day 1 titer."||||||1.0000
72456497|NCT00070707|144436251|SUPERIORITY_OR_OTHER_LEGACY|||||||0.231|||||||ANOVA|||Change at Final Week (PM)||||0.231
72456498|NCT00070707|144436252|SUPERIORITY_OR_OTHER_LEGACY|||||||0.745|||||||ANOVA|||Baseline (AM)||||0.745
72456499|NCT00070707|144436252|SUPERIORITY_OR_OTHER_LEGACY|||||||0.25|||||||ANOVA|||Change at Week 1 (AM)||||0.250
72456500|NCT00070707|144436252|SUPERIORITY_OR_OTHER_LEGACY|Change at Week 2 (AM)||||||0.202|||||||ANOVA|||||||0.202
72456501|NCT00070707|144436252|SUPERIORITY_OR_OTHER_LEGACY|Change at Week 3 (AM)||||||0.104|||||||ANOVA|||||||0.104
72456502|NCT00070707|144436252|SUPERIORITY_OR_OTHER_LEGACY|Change at Week 4 (AM)||||||0.348|||||||ANOVA|||||||0.348
72456503|NCT00070707|144436252|SUPERIORITY_OR_OTHER_LEGACY|Change at Final Week (AM)||||||0.355|||||||ANOVA|||||||0.355
72456504|NCT00070707|144436252|SUPERIORITY_OR_OTHER_LEGACY|Baseline (PM)||||||0.851|||||||ANOVA|||||||0.851
72456505|NCT00070707|144436252|SUPERIORITY_OR_OTHER_LEGACY|Change at Week 1 (PM)||||||0.993|||||||ANOVA|||||||0.993
72456506|NCT00070707|144436252|SUPERIORITY_OR_OTHER_LEGACY|Change at Week 2 (PM)||||||0.476|||||||ANOVA|||||||0.476
72456507|NCT00070707|144436252|SUPERIORITY_OR_OTHER_LEGACY|Change at Week 3 (PM)||||||0.149|||||||ANOVA|||||||0.149
72456508|NCT00070707|144436252|SUPERIORITY_OR_OTHER_LEGACY|Change at Week 4 (PM)||||||0.616|||||||ANOVA|||||||0.616
72456509|NCT00070707|144436252|SUPERIORITY_OR_OTHER_LEGACY|Change at Final Week (PM)||||||0.527|||||||ANOVA|||||||0.527
72456510|NCT00070707|144436253|SUPERIORITY_OR_OTHER_LEGACY|||||||0.116|||||||ANOVA|||Baseline (AM)||||0.116
72456511|NCT00070707|144436253|SUPERIORITY_OR_OTHER_LEGACY|||||||0.994|||||||ANOVA|||Change at Week 1 (AM)||||0.994
72456512|NCT00070707|144436253|SUPERIORITY_OR_OTHER_LEGACY|||||||0.961|||||||ANOVA|||Change at Week 2 (AM)||||0.961
72456513|NCT00070707|144436253|SUPERIORITY_OR_OTHER_LEGACY|||||||0.183|||||||ANOVA|||Change at Week 3 (AM)||||0.183
72456514|NCT00070707|144436253|SUPERIORITY_OR_OTHER_LEGACY|||||||0.44|||||||ANOVA|||Change at Week 4 (AM)||||0.440
72456515|NCT00070707|144436253|SUPERIORITY_OR_OTHER_LEGACY|||||||0.838|||||||ANOVA|||Change at Final Week (AM)||||0.838
72456516|NCT00070707|144436253|SUPERIORITY_OR_OTHER_LEGACY|||||||0.096|||||||ANOVA|||Baseline (PM)||||0.096
72456517|NCT00070707|144436253|SUPERIORITY_OR_OTHER_LEGACY|||||||0.362|||||||ANOVA|||Change at Week 1 (PM)||||0.362
72456518|NCT00070707|144436253|SUPERIORITY_OR_OTHER_LEGACY|||||||0.693|||||||ANOVA|||Change at Week 2 (PM)||||0.693
72456519|NCT00070707|144436253|SUPERIORITY_OR_OTHER_LEGACY|||||||0.603|||||||ANOVA|||Change at Week 3 (PM)||||0.603
72456520|NCT00070707|144436253|SUPERIORITY_OR_OTHER_LEGACY|||||||0.579|||||||ANOVA|||Change at Week 4 (PM)||||0.579
72456521|NCT00070707|144436253|SUPERIORITY_OR_OTHER_LEGACY|||||||0.413|||||||ANOVA|||Change at Final Week (PM)||||0.413
72456522|NCT00070707|144436254|SUPERIORITY_OR_OTHER_LEGACY|||||||0.823|||||||ANOVA|||Baseline||||0.823
72456523|NCT00070707|144436254|SUPERIORITY_OR_OTHER_LEGACY|||||||0.744|||||||ANOVA|||Change at Day 15||||0.744
72456524|NCT00070707|144436254|SUPERIORITY_OR_OTHER_LEGACY|||||||0.675|||||||ANOVA|||Change at Day 29||||0.675
72456525|NCT00070707|144436255|SUPERIORITY_OR_OTHER_LEGACY|||||||0.693|||||||ANOVA|||Baseline||||0.693
72456526|NCT00070707|144436255|SUPERIORITY_OR_OTHER_LEGACY|||||||0.818|||||||ANOVA|||Change at Day 15||||0.818
72456527|NCT00070707|144436255|SUPERIORITY_OR_OTHER_LEGACY|||||||0.915|||||||ANOVA|||Change at Day 29||||0.915
72456528|NCT00070707|144436256|SUPERIORITY_OR_OTHER_LEGACY|||||||0.823|||||||ANOVA|||Baseline||||0.823
72456529|NCT00070707|144436256|SUPERIORITY_OR_OTHER_LEGACY|||||||0.202|||||||ANOVA|||Change at Day 15||||0.202
72456530|NCT00070707|144436256|SUPERIORITY_OR_OTHER_LEGACY|||||||0.199|||||||ANOVA|||Change at Day 29||||0.199
72456531|NCT00070707|144436257|SUPERIORITY_OR_OTHER_LEGACY|||||||0.375|||||||ANOVA|||Baseline||||0.375
72456532|NCT00070707|144436257|SUPERIORITY_OR_OTHER_LEGACY|||||||0.71|||||||ANOVA|||Change at Week 1||||0.710
72456533|NCT00070707|144436257|SUPERIORITY_OR_OTHER_LEGACY|||||||0.597|||||||ANOVA|||Change at Week 2||||0.597
72456534|NCT00070707|144436257|SUPERIORITY_OR_OTHER_LEGACY|||||||0.242|||||||ANOVA|||Change at Week 3||||0.242
72456535|NCT00070707|144436257|SUPERIORITY_OR_OTHER_LEGACY|||||||0.696|||||||ANOVA|||Change at Week 4||||0.696
72456536|NCT00070707|144436257|SUPERIORITY_OR_OTHER_LEGACY|||||||0.67|||||||ANOVA|||Change at Final Week||||0.670
72456537|NCT00070707|144436258|SUPERIORITY_OR_OTHER_LEGACY|||||||0.865|||||||ANOVA|||Baseline||||0.865
72456538|NCT00070707|144436258|SUPERIORITY_OR_OTHER_LEGACY|||||||0.025|||||||ANOVA|||Change at Week 1||||0.025
72456539|NCT00070707|144436258|SUPERIORITY_OR_OTHER_LEGACY|||||||0.288|||||||ANOVA|||Change at Week 2||||0.288
72456540|NCT00070707|144436258|SUPERIORITY_OR_OTHER_LEGACY|||||||0.79|||||||ANOVA|||Change at Week 3||||0.790
72456541|NCT00070707|144436258|SUPERIORITY_OR_OTHER_LEGACY|||||||0.211|||||||ANOVA|||Change at Week 4||||0.211
72456542|NCT00070707|144436258|SUPERIORITY_OR_OTHER_LEGACY|||||||0.136|||||||ANOVA|||Change at Final Week||||0.136
72456543|NCT00070707|144436259|SUPERIORITY_OR_OTHER_LEGACY|||||||0.667|||||||ANOVA|||Baseline||||0.667
72456544|NCT00070707|144436259|SUPERIORITY_OR_OTHER_LEGACY|||||||0.656|||||||ANOVA|||Change at Week 1||||0.656
72456545|NCT00070707|144436259|SUPERIORITY_OR_OTHER_LEGACY|||||||0.458|||||||ANOVA|||Change at Week 2||||0.458
72456546|NCT00070707|144436259|SUPERIORITY_OR_OTHER_LEGACY|||||||0.22|||||||ANOVA|||Change at Week 3||||0.220
72456547|NCT00070707|144436259|SUPERIORITY_OR_OTHER_LEGACY|||||||0.775|||||||ANOVA|||Change at Week 4||||0.775
72456548|NCT00070707|144436259|SUPERIORITY_OR_OTHER_LEGACY|||||||0.994|||||||ANOVA|||Change at Final Week||||0.994
72456549|NCT00070707|144436260|SUPERIORITY_OR_OTHER_LEGACY|||||||0.363|||||||ANOVA|||Baseline||||0.363
72456550|NCT00070707|144436260|SUPERIORITY_OR_OTHER_LEGACY|||||||0.262|||||||ANOVA|||Change at Week 1||||0.262
72456551|NCT00070707|144436260|SUPERIORITY_OR_OTHER_LEGACY|||||||0.386|||||||ANOVA|||Change at Week 2||||0.386
72456552|NCT00070707|144436260|SUPERIORITY_OR_OTHER_LEGACY|||||||0.167|||||||ANOVA|||Change at Week 3||||0.167
72456553|NCT00070707|144436260|SUPERIORITY_OR_OTHER_LEGACY|||||||0.505|||||||ANOVA|||Change at Week 4||||0.505
72620743|NCT03992872|144772528|SUPERIORITY|||||||1|||||||Fisher Exact|"Day 57.~Note: A subject has a 4-fold rise at a visit if they achieve a titer at that visit that is at least 4-fold higher than their Day 1 titer."||||||1.0000
72620744|NCT03992872|144772528|SUPERIORITY|||||||0.1124|||||||Fisher Exact|"Day 182.~Note: A subject has a 4-fold rise at a visit if they achieve a titer at that visit that is at least 4-fold higher than their Day 1 titer."||||||0.1124
72456554|NCT00070707|144436260|SUPERIORITY_OR_OTHER_LEGACY|||||||0.725|||||||ANOVA|||Change at Final Week||||0.725
72456555|NCT00070707|144436261|SUPERIORITY_OR_OTHER_LEGACY|||||||0.954|||||||Cochran-Mantel-Haenszel|Stratified by center||Asthma Symptoms: Day 15||||0.954
72456556|NCT00070707|144436261|SUPERIORITY_OR_OTHER_LEGACY|||||||0.295|||||||Cochran-Mantel-Haenszel|Stratified by center||Asthma Symptoms: Day 29||||0.295
72456557|NCT00070707|144436262|SUPERIORITY_OR_OTHER_LEGACY|||||||0.268|||||||Cochran-Mantel-Haenszel|Stratified by center||SAR Nasal Symptoms: Day 15||||0.268
72620745|NCT03992872|144772529|SUPERIORITY||||||>|0.9999|||||||Fisher Exact|||"Null hypothesis for analysis of percentage of subjects with Anti-Chikungunya neutralizing activity at or above selected thresholds by time point.~Day 1 : Subjects with Titer \>=40"||||>0.9999
72620746|NCT03992872|144772529|SUPERIORITY||||||>|0.9999|||||||Fisher Exact|||"Null hypothesis for analysis of percentage of subjects with Anti-Chikungunya neutralizing activity at or above selected thresholds by time point~Day 1: Subjects with Titer \>=160"||||>0.9999
72620747|NCT03992872|144772529|SUPERIORITY|||||||1|||||||Fisher Exact|||"Null hypothesis for analysis of percentage of subjects with Anti-Chikungunya neutralizing activity at or above selected thresholds by time point.~Day 1: Subjects with Titer \>=640"||||1.0000
72456558|NCT00070707|144436262|SUPERIORITY_OR_OTHER_LEGACY|||||||0.154|||||||Cochran-Mantel-Haenszel|Stratified by center||SAR Nasal Symptoms: Day 29||||0.154
72456559|NCT03928743|144436263|SUPERIORITY||Odds Ratio (OR)|2.88|||<|0.001|TWO_SIDED|95.0|1.71|4.87|||Regression, Logistic|||||4.87|1.71|<0.001
72456560|NCT03928743|144436264|SUPERIORITY||Odds Ratio (OR)|2.8|||<|0.001|TWO_SIDED|95.0|1.59|4.93|||Regression, Logistic|||||4.93|1.59|<0.001
72456561|NCT03928743|144436265|SUPERIORITY||Odds Ratio (OR)|2.66|||<|0.001|TWO_SIDED|95.0|1.65|4.28|||Regression, Logistic|||||4.28|1.65|<0.001
72456562|NCT03928743|144436266|SUPERIORITY||LS Mean difference|-1.04|||<|0.001|TWO_SIDED|95.0|-1.48|-0.59|||Regression, Logistic|||||-0.59|-1.48|<0.001
72456563|NCT03928743|144436267|SUPERIORITY||Odds Ratio (OR)|4.26|||<|0.001|TWO_SIDED|95.0|1.93|9.39|||Regression, Logistic|||||9.39|1.93|<0.001
72456564|NCT03928743|144436268|SUPERIORITY||Odds Ratio (OR)|6.47|||<|0.001|TWO_SIDED|95.0|2.67|15.65|||Regression, Logistic|||||15.65|2.67|<0.001
72456565|NCT03928743|144436269|SUPERIORITY||Odds Ratio (OR)|4.65|||<|0.001|TWO_SIDED|4.65|2.51|7.57|||Regression, Logistic|||||7.57|2.51|<0.001
72456566|NCT03928743|144436270|SUPERIORITY||LS Mean difference|-1.05|||<|0.001|TWO_SIDED|95.0|-1.48|-0.63|||Regression, Logistic|||||-0.63|-1.48|<0.001
72456567|NCT03928743|144436271|SUPERIORITY||LS Mean difference|-1.48|||<|0.001|TWO_SIDED|95.0|-2.0|-0.96|||Regression, Logistic|||||-0.96|-2.00|<0.001
72456568|NCT03928743|144436272|SUPERIORITY||LS Mean difference|-1.52|||<|0.001|TWO_SIDED|95.0|-2.36|-0.68|||Regression, Logistic|||||-0.68|-2.36|<0.001
72456569|NCT03928743|144436273|SUPERIORITY||LS Mean difference|3.38|||<|0.001|TWO_SIDED|95.0|1.67|5.09|||Regression, Logistic|||||5.09|1.67|<0.001
72456570|NCT03928743|144436274|SUPERIORITY||LS Mean difference|-0.28||||0.006|TWO_SIDED|95.0|-0.47|-0.08|||Regression, Logistic|||||-0.08|-0.47|0.006
72456571|NCT03928743|144436275|SUPERIORITY||LS Mean difference|-1.08||||0.003|TWO_SIDED|95.0|-1.79|-0.38|||Regression, Logistic|||||-0.38|-1.79|0.003
72456572|NCT03928743|144436276|SUPERIORITY||Odds Ratio (OR)|2.47||||0.006|TWO_SIDED|95.0|1.3|4.68|||Regression, Logistic|||||4.68|1.30|0.006
72456573|NCT02224755|144436287|NON_INFERIORITY|Non-inferiority would be demonstrated if the 95% lower confidence boundary for the difference between treatment groups (HM3 - HMII) in the occurrence of the primary end point would be greater than -10 percentage points, at a one-sided alpha level of 0.025 or a two-tailed P value of less than 0.05.|Risk Difference (RD)|9.4|||<|0.001|ONE_SIDED|95.0|-2.1||||Farrington-Manning risk difference||||||-2.1|<0.001
72456574|NCT02224755|144436288|NON_INFERIORITY|Non-inferiority would be demonstrated if the 95% lower confidence boundary for the difference between treatment groups (HM3 - HMII) in the occurrence of the primary end point would be greater than -10 percentage points, at a one-sided alpha level of 0.025 or a two-tailed P value of less than 0.05.|Risk Difference (RD)|19.2|||<|0.001|ONE_SIDED|95.0|9.8||||Farrington-Manning risk difference||||||9.8|<0.001
72456575|NCT02224755|144436289|SUPERIORITY||Risk Ratio (RR)|0.21|||<|0.001|TWO_SIDED|95.0|0.11|0.38|||Fisher Exact|||Based on data in the Sponsor's device tracking database, 7% of patients with the HeartMate II LVAS receive a pump replacement by 24 months. The expected proportion of patients with the HeartMate 3 LVAS to receive a pump replacement by 24 months was assumed to be 3%. We estimated that to demonstrate superiority of HeartMate 3 to HeartMate II with a power of 80% and α = 0.05 (2-sided), a total of 1028 patients (514 per arm) were required using the Fisher's exact test.||.38|.11|<0.001
72456576|NCT02736188|144436298|SUPERIORITY||LS Mean Difference|0.8||||0.4287|TWO_SIDED|95.0|-1.17|2.77||Baseline is fit into the model as a covariate.|generalized estimating equation (GEE)|||Week 8||2.77|-1.17|0.4287
72456577|NCT02736188|144436298|SUPERIORITY||LS Mean Difference|0.36||||0.7031|TWO_SIDED|95.0|-1.49|2.21||Baseline is fit into the model as a covariate.|GEE model|||Week 16||2.21|-1.49|0.7031
72456578|NCT02736188|144436298|SUPERIORITY||LS Mean Difference|-0.91||||0.4253|TWO_SIDED|95.0|-3.14|1.32||Baseline is fit into the model as a covariate.|GEE model|||Week 24||1.32|-3.14|0.4253
72456579|NCT02736188|144436298|SUPERIORITY||LS Mean Difference|-0.06||||0.9747|TWO_SIDED|95.0|-3.49|3.38||Baseline is fit into the model as a covariate.|GEE model|||Week 48||3.38|-3.49|0.9747
72456580|NCT02736188|144436299|SUPERIORITY||LS Mean Difference|-0.27||||0.4721|TWO_SIDED|95.0|-1.01|0.47||Baseline is fit into the model as a covariate.|GEE model|||Week 8||0.47|-1.01|0.4721
72456581|NCT02736188|144436299|SUPERIORITY||LS Mean Difference|-0.19||||0.6611|TWO_SIDED|95.0|-1.02|0.64||Baseline is fit into the model as a covariate.|GEE model|||Week 16||0.64|-1.02|0.6611
72456582|NCT02736188|144436299|SUPERIORITY||LS Mean Difference|-0.44||||0.276|TWO_SIDED|95.0|-1.22|0.35|||GEE model|Baseline is fit into the model as a covariate.||Week 24||0.35|-1.22|0.2760
72456583|NCT02736188|144436299|SUPERIORITY||LS Mean Difference|-0.28||||0.6977|TWO_SIDED|95.0|-1.69|1.13||Baseline is fit into the model as a covariate.|GEE model|||Week 48||1.13|-1.69|0.6977
72456584|NCT02736188|144436300|SUPERIORITY||Difference in LS Means|0.7||||0.0648|TWO_SIDED|95.0|-0.04|1.45||Baseline is fit into the model as a covariate.|GEE model|||Week 8||1.45|-0.04|0.0648
72456585|NCT02736188|144436300|SUPERIORITY||difference in LS means|0.74||||0.0692|TWO_SIDED|95.0|-0.06|1.55||Baseline is fit into the model as a covariate.|GEE model|||Week 16||1.55|-0.06|0.0692
72456586|NCT02736188|144436300|SUPERIORITY||difference in LS means|0.44||||0.4317|TWO_SIDED|95.0|-0.65|1.52||Baseline is fit into the model as a covariate.|GEE model|||Week 24||1.52|-0.65|0.4317
72456587|NCT02736188|144436300|SUPERIORITY||difference in LS means|-0.34||||0.6416|TWO_SIDED|95.0|-1.78|1.1||Baseline is fit into the model as a covariate.|GEE model|||Week 48||1.10|-1.78|0.6416
72456588|NCT02736188|144436301|SUPERIORITY||difference in LS means|0.78||||0.6546|TWO_SIDED|95.0|-2.65|4.22||Baseline is fit into the model as a covariate.|GEE model|||Week 8||4.22|-2.65|0.6546
72456589|NCT02736188|144436301|SUPERIORITY||difference in LS means|-0.64||||0.7054|TWO_SIDED|95.0|-3.97|2.69||Baseline is fit into the model as a covariate.|GEE model|||Week 16||2.69|-3.97|0.7054
72620748|NCT03992872|144772529|SUPERIORITY|||||||0.0257|||||||Fisher Exact|||"Null hypothesis for analysis of percentage of subjects with Anti-Chikungunya neutralizing activity at or above selected thresholds by time point.~Day 8 : Subjects with Titer \>=40"||||0.0257
72370438|NCT00488683|144251631|SUPERIORITY_OR_OTHER||R-square|0.005||||||95.0||||Values from Group 1, 2 and 3 were combined for this analysis.|Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccinations and memory B cells at 12 months of age for the serogroup A||||
72456590|NCT02736188|144436301|SUPERIORITY||difference in LS means|-0.5||||0.8441|TWO_SIDED|95.0|-5.45|4.45||Baseline is fit into the model as a covariate.|GEE model|||Week 24||4.45|-5.45|0.8441
72456591|NCT02736188|144436301|SUPERIORITY||difference in LS means|4.15||||0.0864|TWO_SIDED|95.0|-0.59|8.9||Baseline is fit into the model as a covariate.|GEE model|||Week 48||8.90|-0.59|0.0864
72456592|NCT02736188|144436302|SUPERIORITY||difference in LS means|0.06||||0.8603|TWO_SIDED|95.0|-0.65|0.78||Baseline is fit into the model as a covariate.|GEE model|||Week 8||0.78|-0.65|0.8603
72456593|NCT02736188|144436302|SUPERIORITY||difference in LS means|-0.18||||0.6154|TWO_SIDED|95.0|-0.86|0.51||Baseline is fit into the model as a covariate.|GEE model|||Week 16||0.51|-0.86|0.6154
72456594|NCT02736188|144436302|SUPERIORITY||difference in LS means|0.47||||0.1999|TWO_SIDED|95.0|-0.25|1.2||Baseline is fit into the model as a covariate.|GEE model|||Week 24||1.20|-0.25|0.1999
72456595|NCT02736188|144436302|SUPERIORITY||difference in LS means|-0.03||||0.9568|TWO_SIDED|95.0|-1.25|1.18||Baseline is fit into the model as a covariate.|GEE model|||Week 48||1.18|-1.25|0.9568
72456596|NCT02736188|144436303|SUPERIORITY||difference in LS means|0.45||||0.5447|TWO_SIDED|95.0|-1.0|1.9||Baseline is fit into the model as a covariate.|GEE model|||Week 8||1.90|-1.00|0.5447
72456597|NCT02736188|144436303|SUPERIORITY||difference in LS means|-0.56||||0.5051|TWO_SIDED|95.0|-2.22|1.09||Baseline is fit into the model as a covariate.|GEE model|||Week 16||1.09|-2.22|0.5051
72456598|NCT02736188|144436303|SUPERIORITY||difference in LS means|0.27||||0.7478|TWO_SIDED|95.0|-1.36|1.9||Baseline is fit into the model as a covariate.|GEE model|||Week 24||1.90|-1.36|0.7478
72456599|NCT02736188|144436303|SUPERIORITY||difference in LS means|-0.41||||0.7429|TWO_SIDED|95.0|-2.86|2.04||Baseline is fit into the model as a covariate.|GEE model|||Week 48||2.04|-2.86|0.7429
72456600|NCT02736188|144436304|SUPERIORITY||difference in LS means|2.0||||0.6434|TWO_SIDED|95.0|-6.48|10.49||Baseline is fit into the model as a covariate.|GEE model|||Week 8||10.49|-6.48|0.6434
72456601|NCT02736188|144436304|SUPERIORITY||difference in LS means|-1.99||||0.7118|TWO_SIDED|95.0|-12.53|8.55||Baseline is fit into the model as a covariate.|GEE model|||Week 16||8.55|-12.53|0.7118
72456602|NCT02736188|144436304|SUPERIORITY||difference in LS means|4.15||||0.4399|TWO_SIDED|95.0|-6.39|14.69||Baseline is fit into the model as a covariate.|GEE model|||Week 24||14.69|-6.39|0.4399
72456603|NCT02736188|144436304|SUPERIORITY||difference in LS means|7.98||||0.443|TWO_SIDED|95.0|-12.41|28.37||Baseline is fit into the model as a covariate.|GEE model|||Week 48||28.37|-12.41|0.4430
72456604|NCT02736188|144436305|SUPERIORITY||difference in LS means|0.28||||0.6428|TWO_SIDED|95.0|-0.9|1.46||Baseline is fit into the model as a covariate.|GEE model|||Week 8||1.46|-0.90|0.6428
72456605|NCT02736188|144436305|SUPERIORITY||difference in LS means|-0.25||||0.7334|TWO_SIDED|95.0|-1.72|1.21||Baseline is fit into the model as a covariate.|GEE model|||Week 16||1.21|-1.72|0.7334
72500194|NCT02537678|144530744|NON_INFERIORITY|We planned 0.41 standard deviation as the non-inferiority margin (which is less than half of the effect size) for the one-side testing. Non-inferiority analysis with alpha 2.5% was applied at post assessment.|Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.2||0.001|ONE_SIDED|97.5|-0.39||||t-test, 1 sided||||Treatment difference = standard TF-CBT - stepped care TF-CBT||-0.39|0.001
72500195|NCT02537678|144530745|NON_INFERIORITY|We planned 0.41 standard deviation as the non-inferiority margin (which is less than half of the effect size) for the one-side testing. Non-inferiority analysis with alpha 2.5% was applied at 6-month assessment.|Mean Difference (Final Values)|-0.04|STANDARD_ERROR_OF_MEAN|0.22||0.003|ONE_SIDED|97.5|-0.47||||t-test, 1 sided||||Treatment difference = standard TF-CBT - stepped care TF-CBT||-0.47|0.003
72500196|NCT02537678|144530746|NON_INFERIORITY|We planned 0.41 standard deviation as the non-inferiority margin (which is less than half of the effect size) for the one-side testing. Non-inferiority analysis with alpha 2.5% was applied at 12-month assessment.|Mean Difference (Final Values)|0.03|STANDARD_ERROR_OF_MEAN|0.17|<|0.001|ONE_SIDED|97.5|-0.3||||t-test, 1 sided||||Treatment difference = standard TF-CBT - stepped care TF-CBT||-0.30|<0.001
72500197|NCT02537678|144530747|NON_INFERIORITY|We planned 0.41 standard deviation as the non-inferiority margin (which is less than half of the effect size) for the one-side testing. Non-inferiority analysis with alpha 2.5% was applied at post assessment.|Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.14||0.001|ONE_SIDED|97.5|-0.29||||t-test, 1 sided||||Treatment difference = standard TF-CBT - stepped care TF-CBT||-0.29|0.001
72500198|NCT02537678|144530748|NON_INFERIORITY|We planned 0.41 standard deviation as the non-inferiority margin (which is less than half of the effect size) for the one-side testing. Non-inferiority analysis with alpha 2.5% was applied at 6-month assessment.|Mean Difference (Final Values)|-0.07|STANDARD_ERROR_OF_MEAN|0.16||0.004|ONE_SIDED|97.5|-0.38||||t-test, 1 sided||||Treatment difference = standard TF-CBT - stepped care TF-CBT||-0.38|0.004
72500199|NCT02537678|144530749|NON_INFERIORITY|We planned 0.41 standard deviation as the non-inferiority margin (which is less than half of the effect size) for the one-side testing. Non-inferiority analysis with alpha 2.5% was applied at 12-month assessment.|Mean Difference (Final Values)|0.04|STANDARD_ERROR_OF_MEAN|0.12|<|0.001|ONE_SIDED|97.5|-0.19||||t-test, 1 sided||||Treatment difference = standard TF-CBT - stepped care TF-CBT||-0.19|<0.001
72500200|NCT02537678|144530750|NON_INFERIORITY|We planned 0.41 standard deviation as the non-inferiority margin (which is less than half of the effect size) for the one-side testing. Non-inferiority analysis with alpha 2.5% was applied at post assessment.|Mean Difference (Final Values)|-0.43|STANDARD_ERROR_OF_MEAN|1.47||0.005|ONE_SIDED|97.5|-3.33||||t-test, 1 sided||||Treatment difference = standard TF-CBT - stepped care TF-CBT||-3.33|0.005
72563008|NCT00292227|144658086|NON_INFERIORITY_OR_EQUIVALENCE|A standard deviation of 12ms was assumed for sample size calculation. Sample size was calculated to have 90% power to show the non-inferiority of rotigotine against placebo with respect to the non-inferiority margin of 10ms (α=0.05, 1-sided).|Mean Difference (Net)|-0.26||||||90.0|-2.29|1.78|||ANCOVA|The ANCOVA model included the factors site, treatment, gender, and time-matched baseline QTcI as covariate.|The direction of the estimate is Rotigotine - Placebo. Mean difference was estimated from the ANCOVA model.|The analysis was based on a non-inferiority comparison of rotigotine vs placebo using a 1-sided 95% confidence interval (or, equivalently, the upper limit of 2-sided 90% confidence interval) for the time-matched changes from Baseline in QTcI.||1.78|-2.29|
72620749|NCT03992872|144772529|SUPERIORITY|||||||0.037|||||||Fisher Exact|||"Null hypothesis for analysis of percentage of subjects with Anti-Chikungunya neutralizing activity at or above selected thresholds by time point~Day 8: Subjects with Titer \>=160"||||0.0370
72620750|NCT03992872|144772529|SUPERIORITY|||||||0.1806|||||||Fisher Exact|||"Null hypothesis for analysis of percentage of subjects with Anti-Chikungunya neutralizing activity at or above selected thresholds by time point.~Day 8: Subjects with Titer \>=640"||||0.1806
72620751|NCT03992872|144772529|SUPERIORITY|||||||1|||||||Fisher Exact|||"Null hypothesis for analysis of percentage of subjects with Anti-Chikungunya neutralizing activity at or above selected thresholds by time point.~Day 22: Subjects with Titer \>=40"||||1.0000
72500201|NCT02537678|144530751|NON_INFERIORITY|We planned 0.41 standard deviation as the non-inferiority margin (which is less than half of the effect size) for the one-side testing. Non-inferiority analysis with alpha 2.5% was applied at 6-month assessment.|Mean Difference (Final Values)|-1.47|STANDARD_ERROR_OF_MEAN|1.78||0.028|ONE_SIDED|97.5|-4.99||||t-test, 1 sided||||Treatment difference = standard TF-CBT - stepped care TF-CBT||-4.99|0.028
72500202|NCT02537678|144530752|NON_INFERIORITY|We planned 0.41 standard deviation as the non-inferiority margin (which is less than half of the effect size) for the one-side testing. Non-inferiority analysis with alpha 2.5% was applied at 12-month assessment.|Mean Difference (Final Values)|-0.44|STANDARD_ERROR_OF_MEAN|1.62||0.009|ONE_SIDED|97.5|-3.64||||t-test, 1 sided||||Treatment difference = standard TF-CBT - stepped care TF-CBT||-3.64|0.009
72370439|NCT00488683|144251631|SUPERIORITY_OR_OTHER||R-square|0.02||||||95.0||||Values from Group 1, 2 and 3 were combined for this analysis.|Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccinations and memory B cells at 12 months of age for the serogroup C||||
72500203|NCT02537678|144530753|NON_INFERIORITY|We planned 0.41 standard deviation as the non-inferiority margin (which is less than half of the effect size) for the one-side testing. Non-inferiority analysis with alpha 2.5% was applied at post assessment.|Mean Difference (Final Values)|-1.05|STANDARD_ERROR_OF_MEAN|0.9||0.006|ONE_SIDED|97.5|-2.82||||t-test, 1 sided||||Treatment difference = standard TF-CBT - stepped care TF-CBT||-2.82|0.006
72500204|NCT02537678|144530754|NON_INFERIORITY|We planned 0.41 standard deviation as the non-inferiority margin (which is less than half of the effect size) for the one-side testing. Non-inferiority analysis with alpha 2.5% was applied at 6-month assessment.|Mean Difference (Final Values)|-0.57|STANDARD_ERROR_OF_MEAN|0.88||0.001|ONE_SIDED|97.5|-2.31||||t-test, 1 sided||||Treatment difference = standard TF-CBT - stepped care TF-CBT||-2.31|0.001
72620752|NCT03992872|144772529|SUPERIORITY|||||||1|||||||Fisher Exact|||"Null hypothesis for analysis of percentage of subjects with Anti-Chikungunya neutralizing activity at or above selected thresholds by time point~Day 22: Subjects with Titer \>=160"||||1.0000
72620753|NCT03992872|144772529|SUPERIORITY|||||||0.0797|||||||Fisher Exact|||"Null hypothesis for analysis of percentage of subjects with Anti-Chikungunya neutralizing activity at or above selected thresholds by time point~Day 22: Subjects with Titer \>=640"||||0.0797
72456606|NCT02736188|144436305|SUPERIORITY||difference in LS means|0.58||||0.4409|TWO_SIDED|95.0|-0.89|2.04||Baseline is fit into the model as a covariate.|GEE model|||Week 24||2.04|-0.89|0.4409
72456607|NCT02736188|144436305|SUPERIORITY||difference in LS means|0.99||||0.4687|TWO_SIDED|95.0|-1.69|3.68||Baseline is fit into the model as a covariate.|GEE model|||Week 48||3.68|-1.69|0.4687
72456608|NCT02736188|144436306|SUPERIORITY||difference in LS means|1.14||||0.1502|TWO_SIDED|95.0|-0.41|2.69||Baseline is fit into the model as a covariate.|GEE model|||Week 8||2.69|-0.41|0.1502
72456609|NCT02736188|144436306|SUPERIORITY||difference in LS means|-0.2||||0.8188|TWO_SIDED|-1.89|-1.89|1.49||Baseline is fit into the model as a covariate.|GEE model|||Week 16||1.49|-1.89|0.8188
72456610|NCT02736188|144436306|SUPERIORITY||difference in LS means|0.8||||0.5122|TWO_SIDED|95.0|-1.58|3.17||Baseline is fit into the model as a covariate.|GEE model|||Week 24||3.17|-1.58|0.5122
72456611|NCT02736188|144436306|SUPERIORITY||difference in LS means|0.72||||0.7022|TWO_SIDED|95.0|-2.96|4.4||Baseline is fit into the model as a covariate.|GEE model|||Week 48||4.40|-2.96|0.7022
72456612|NCT02736188|144436307|SUPERIORITY||difference in LS means|0.19||||0.7906|TWO_SIDED|95.0|-1.22|1.6||Baseline is fit into the model as a covariate.|GEE model|||Week 8||1.60|-1.22|0.7906
72456613|NCT02736188|144436307|SUPERIORITY||difference in LS means|0.66||||0.3531|TWO_SIDED|95.0|-0.74|2.07||Baseline is fit into the model as a covariate.|GEE model|||Week 16||2.07|-0.74|0.3531
72456614|NCT02736188|144436307|SUPERIORITY||difference in LS means|0.15||||0.8846|TWO_SIDED|95.0|-1.92|2.23||Baseline is fit into the model as a covariate.|GEE model|||Week 24||2.23|-1.92|0.8846
72456615|NCT02736188|144436307|SUPERIORITY||difference in LS means|2.08||||0.0168|TWO_SIDED|95.0|0.38|3.79||Baseline is fit into the model as a covariate.|GEE model|||Week 48||3.79|0.38|0.0168
72456616|NCT00240994|144436308|SUPERIORITY_OR_OTHER||Proportion with graft loss or death|0.057|||||TWO_SIDED|95.0|0.007|0.192|||95% Confidence Interval|95% CI using an exact binomial method||The proportion of participants with graft loss or death within 12 months post kidney transplantation is descriptively summarized with a 95% confidence interval using an exact binomial method.||0.192|0.007|
72456617|NCT00854594|144436315|SUPERIORITY_OR_OTHER|||||||0.26|TWO_SIDED||||||t-test, 2 sided|||Null hypothesis: pre-intervention efficacies will be equal in the two study arms.||||0.26
72456618|NCT00854594|144436316|SUPERIORITY_OR_OTHER|||||||0.74|TWO_SIDED||||||t-test, 2 sided|||Null hypothesis: post-intervention efficacies will be equal in the two study arms.||||0.74
72456619|NCT00749944|144436324|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.72|||||TWO_SIDED|95.0|-0.33|1.77||||||There was no hypothesis testing or power calculation in this study. Period AB: Difference varenicline versus placebo.||1.77|-0.33|
72620754|NCT03992872|144772529|SUPERIORITY|||||||1|||||||Fisher Exact|||"Null hypothesis for analysis of percentage of subjects with Anti-Chikungunya neutralizing activity at or above selected thresholds by time point.~Day 29: Subject with Titer \>=40"||||1.0000
72456620|NCT00749944|144436324|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.46|||||TWO_SIDED|95.0|-0.5|1.43||||||Period AC: Difference varenicline versus placebo.||1.43|-0.50|
72456621|NCT00749944|144436324|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.92|||||TWO_SIDED|95.0|-0.27|2.11||||||Period AD: Difference varenicline versus placebo.||2.11|-0.27|
72456622|NCT00749944|144436324|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.5|||||TWO_SIDED|95.0|-0.52|1.53||||||Period AE: Difference varenicline versus placebo.||1.53|-0.52|
72456623|NCT00749944|144436324|SUPERIORITY_OR_OTHER||Difference (change from baseline)|-0.43|||||TWO_SIDED|95.0|-1.35|0.5|||||Mixed Models Analysis|Period BC: Difference varenicline versus placebo.||0.50|-1.35|
72456624|NCT00749944|144436324|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.03|||||TWO_SIDED|95.0|-1.18|1.24||||||Period BD: Difference varenicline versus placebo.||1.24|-1.18|
72456625|NCT00749944|144436324|SUPERIORITY_OR_OTHER||Difference (change from baseline)|-0.37|||||TWO_SIDED|95.0|-1.37|0.63|||||Mixed Models Analysis|Period BE: Difference varenicline versus placebo.||0.63|-1.37|
72456626|NCT00749944|144436325|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.62|||||TWO_SIDED|95.0|-0.15|1.39||||||There was no hypothesis testing or power calculation in this study. Period AB: Difference varenicline versus placebo.||1.39|-0.15|
72456627|NCT00749944|144436325|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.41|||||TWO_SIDED|95.0|-0.24|1.07||||||Period AC: Difference varenicline versus placebo.||1.07|-0.24|
72456628|NCT00749944|144436325|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.48|||||TWO_SIDED|95.0|-0.26|1.22||||||Period AD: Difference varenicline versus placebo.||1.22|-0.26|
72456629|NCT00749944|144436325|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.44|||||TWO_SIDED|95.0|-0.18|1.06||||||Period AE: Difference varenicline versus placebo.||1.06|-0.18|
72456630|NCT00749944|144436325|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.1|||||TWO_SIDED|95.0|-0.58|0.78||||||Period BC: Difference varenicline versus placebo.||0.78|-0.58|
72456631|NCT00749944|144436325|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.22|||||TWO_SIDED|95.0|-0.48|0.92||||||Period BD: Difference varenicline versus placebo.||0.92|-0.48|
72456632|NCT00749944|144436325|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.23|||||TWO_SIDED|95.0|-0.26|0.72||||||Period BE: Difference varenicline versus placebo.||0.72|-0.26|
72456633|NCT00749944|144436326|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.62|||||TWO_SIDED|95.0|0.0|1.24||||||There was no hypothesis testing or power calculation in this study. Period AB: Difference varenicline versus placebo.||1.24|-0.00|
72456634|NCT00749944|144436326|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.73|||||TWO_SIDED|95.0|0.18|1.29||||||Period AC: Difference varenicline versus placebo.||1.29|0.18|
72456635|NCT00749944|144436326|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.66|||||TWO_SIDED|95.0|0.02|1.3||||||Period AD: Difference varenicline versus placebo.||1.30|0.02|
72456636|NCT00749944|144436326|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.43|||||TWO_SIDED|95.0|-0.19|1.05||||||Period AE: Difference varenicline versus placebo.||1.05|-0.19|
72456637|NCT00749944|144436326|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.48|||||TWO_SIDED|95.0|-0.09|1.05||||||Period BC: Difference varenicline versus placebo.||1.05|-0.09|
72456638|NCT00749944|144436326|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.39|||||TWO_SIDED|95.0|-0.28|1.06||||||Period BD: Difference varenicline versus placebo.||1.06|-0.28|
72620755|NCT03992872|144772529|SUPERIORITY|||||||1|||||||Fisher Exact|||"Null hypothesis for analysis of percentage of subjects with Anti-Chikungunya neutralizing activity at or above selected thresholds by time point.~Day 29: Subject with Titer \>=160"||||1.0000
72456639|NCT00749944|144436326|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.09|||||TWO_SIDED|95.0|-0.47|0.65||||||Period BE: Difference varenicline versus placebo.||0.65|-0.47|
72456640|NCT00749944|144436327|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.85|||||TWO_SIDED|95.0|-0.02|1.72|||||Mixed Models Analysis included baseline, treatment (t; fixed), subject (random), day (d; fixed), and interaction for t-by-d.|There was no hypothesis testing or power calculation in this study. Period AB: Difference varenicline versus placebo.||1.72|-0.02|
72456641|NCT00749944|144436327|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.85|||||TWO_SIDED|95.0|0.16|1.54|||||Mixed Models Analysis included baseline, t (fixed), subject (random), d (fixed), and interaction for t-by-d.|Period AC: Difference varenicline versus placebo.||1.54|0.16|
72456642|NCT00749944|144436327|SUPERIORITY_OR_OTHER||Difference (change from baseline)|1.24|||||TWO_SIDED|95.0|0.39|2.08|||||Mixed Models Analysis included baseline, t (fixed), subject (random), d (fixed), and interaction for t-by-d.|Period AD: Difference varenicline versus placebo.||2.08|0.39|
72456643|NCT00749944|144436327|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.83|||||TWO_SIDED|95.0|0.14|1.52|||||Mixed Models Analysis included baseline, t (fixed), subject (random), d (fixed), and interaction for t-by-d.|Period AE: Difference varenicline versus placebo.||1.52|0.14|
72456644|NCT00749944|144436327|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.52|||||TWO_SIDED|95.0|-0.06|1.09|||||Mixed Models Analysis included baseline, t (fixed), subject (random), time (fixed), d (fixed), and interactions for t-by-time, t-by-d, time-by-d and t-by-time-by-d.|Period BC: Difference varenicline versus placebo.||1.09|-0.06|
72500205|NCT02537678|144530755|NON_INFERIORITY|We planned 0.41 standard deviation as the non-inferiority margin (which is less than half of the effect size) for the one-side testing. Non-inferiority analysis with alpha 2.5% was applied at 12-month assessment.|Median Difference (Final Values)|0.21|STANDARD_ERROR_OF_MEAN|0.83|<|0.001|ONE_SIDED|97.5|-1.43||||t-test, 1 sided||||Treatment difference = standard TF-CBT - stepped care TF-CBT||-1.43|<0.001
72500206|NCT02537678|144530756|NON_INFERIORITY|For the non-inferiority margin for the PCL-5, the clinically significant change threshold is 10 points although adult PTSD trials have used -5 to -10 points. We used -8.8 as the margin which was based on an expert panel and prior studies with adults. Non-inferiority analysis with alpha 2.5% was applied at post assessment.|Mean Difference (Final Values)|-0.77|STANDARD_ERROR_OF_MEAN|2.16|<|0.001|ONE_SIDED|97.5|-5.04||||t-test, 1 sided||||Treatment difference = standard TF-CBT - stepped care TF-CBT||-5.04|<0.001
72500207|NCT02537678|144530757|NON_INFERIORITY|For the non-inferiority margin for the PCL-5, the clinically significant change threshold is 10 points although adult PTSD trials have used -5 to -10 points. We used -8.8 as the margin which was based on an expert panel and prior studies with adults. Non-inferiority analysis with alpha 2.5% was applied at 6-month assessment.|Mean Difference (Final Values)|-2.4|STANDARD_ERROR_OF_MEAN|2.27||0.003|ONE_SIDED|97.5|-6.87||||t-test, 1 sided||||Treatment difference = standard TF-CBT - stepped care TF-CBT||-6.87|0.003
72500208|NCT02537678|144530758|NON_INFERIORITY|For the non-inferiority margin for the PCL-5, the clinically significant change threshold is 10 points although adult PTSD trials have used -5 to -10 points. We used -8.8 as the margin which was based on an expert panel and prior studies with adults.Non-inferiority analysis with alpha 2.5% was applied at 12-month assessment.|Mean Difference (Final Values)|-1.74|STANDARD_ERROR_OF_MEAN|2.06|<|0.001|ONE_SIDED|97.5|-5.8||||t-test, 1 sided||||Treatment difference = standard TF-CBT - stepped care TF-CBT||-5.80|<0.001
72500209|NCT01360996|144530759|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||||||<.0001
72456645|NCT00749944|144436327|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.88|||||TWO_SIDED|95.0|0.05|1.7|||||Mixed Models Analysis included baseline, t (fixed), subject (random), d (fixed), and interaction for t-by-d.|Period BD: Difference varenicline versus placebo.||1.70|0.05|
72456646|NCT00749944|144436327|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.38|||||TWO_SIDED|95.0|-0.12|0.88|||||Mixed Models Analysis included baseline, t (fixed), subject (random), d (fixed), and interaction for t-by-d.|Period BE: Difference varenicline versus placebo.||0.88|-0.12|
72500210|NCT01360996|144530760|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||||||>0.05
72500211|NCT01360996|144530761|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||||||>0.05
72500212|NCT01360996|144530762|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA|||||||<0.001
72620756|NCT03992872|144772529|SUPERIORITY|||||||0.1284|||||||Fisher Exact|||"Null hypothesis for analysis of percentage of subjects with Anti-Chikungunya neutralizing activity at or above selected thresholds by time point.~Day 29: Subject with Titer \>= 640"||||0.1284
72456647|NCT00749944|144436328|SUPERIORITY_OR_OTHER||Difference (change from baseline)|-0.82|||||TWO_SIDED|95.0|-3.07|1.43|||||Mixed Models Analysis included baseline, treatment (t; fixed), subject (random), day (d; fixed), and interaction for t-by-d.|There was no hypothesis testing or power calculation in this study. Period AB: Difference varenicline versus placebo.||1.43|-3.07|
72456648|NCT00749944|144436328|SUPERIORITY_OR_OTHER||Difference (change from baseline)|-0.19|||||TWO_SIDED|95.0|-2.47|2.08|||||Mixed Models Analysis included baseline, t (fixed), subject (random), d (fixed), and interaction for t-by-d.|Period AC: Difference varenicline versus placebo.||2.08|-2.47|
72456649|NCT00749944|144436328|SUPERIORITY_OR_OTHER||Difference (change from baseline)|-2.15|||||TWO_SIDED|95.0|-5.19|0.89|||||Mixed Models Analysis included baseline, t (fixed), subject (random), d (fixed), and interaction for t-by-d.|Period AD: Difference varenicline versus placebo.||0.89|-5.19|
72500213|NCT01360996|144530763|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||McNemar|||||||<0.0001
72500214|NCT01360996|144530764|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA|||||||<0.001
72500215|NCT01360996|144530765|SUPERIORITY_OR_OTHER||||||<|0.04|||||||ANOVA|||||||<0.04
72500216|NCT01478958|144530795|SUPERIORITY_OR_OTHER|||||||0.238||||||Overall diet effect. No post-hoc analyses required. Adjusted for multiple comparisons.|General Linear Model Univariate Analysis|Baseline values for %FMD, BMI, age, gender and intervention diet used as prognostic factors in model.||To detect a 2% inter-group difference in FMD (primary outcome) using a SD of 2.3, 90% power and 5% significance level, n=171 participants were required (n=57 per group), increasing to n=228 to include a 25% dropout rate.||||0.238
72500217|NCT01478958|144530795|SUPERIORITY_OR_OTHER|||||||0.021||||||Effect of the SFA-rich diet relative to baseline.|General Linear Model Univariate Analysis|Baseline values for %FMD, BMI and age, gender and intervention diet were used as prognostic factors in the model.||||||0.021
72620757|NCT03992872|144772529|SUPERIORITY|||||||1|||||||Fisher Exact|||"Null hypothesis for analysis of percentage of subjects with Anti-Chikungunya neutralizing activity at or above selected thresholds by time point.~Day 57: Subject with Titer \>= 40"||||1.0000
72620758|NCT03992872|144772529|SUPERIORITY|||||||0.6411|||||||Fisher Exact|||"Null hypothesis for analysis of percentage of subjects with Anti-Chikungunya neutralizing activity at or above selected thresholds by time point.~Day 57: Subject with Titer\>=160"||||0.6411
72456650|NCT00749944|144436328|SUPERIORITY_OR_OTHER||Difference (change from baseline)|-0.98|||||TWO_SIDED|95.0|-3.67|1.7|||||Mixed Models Analysis included baseline, t (fixed), subject (random), d (fixed), and interaction for t-by-d.|Period AE: Difference varenicline versus placebo.||1.70|-3.67|
72456651|NCT00749944|144436328|SUPERIORITY_OR_OTHER||Difference (change from baseline)|1.95|||||TWO_SIDED|95.0|-0.36|4.26|||||Mixed Models Analysis included baseline, t (fixed), subject (random), time (fixed), d (fixed), and interactions for t-by-time, t-by-d, time-by-d and t-by-time-by-d.|Period BC: Difference varenicline versus placebo.||4.26|-0.36|
72456652|NCT00749944|144436328|SUPERIORITY_OR_OTHER||Difference (change from baseline)|-0.01|||||TWO_SIDED|95.0|-3.32|3.3|||||Mixed Models Analysis included baseline, t (fixed), subject (random), d (fixed), and interaction for t-by-d.|Period BD: Difference varenicline versus placebo.||3.30|-3.32|
72456653|NCT00749944|144436328|SUPERIORITY_OR_OTHER||Difference (change from baseline)|1.09|||||TWO_SIDED|95.0|-1.8|3.97|||||Mixed Models Analysis included baseline, t (fixed), subject (random), d (fixed), and interaction for t-by-d.|Period BE: Difference varenicline versus placebo.||3.97|-1.80|
72456654|NCT00749944|144436329|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.52|||||TWO_SIDED|95.0|-0.29|1.32|||||Mixed Models Analysis included baseline, treatment (t; fixed), subject (random), day (d; fixed), and interaction for t-by-d.|There was no hypothesis testing or power calculation in this study. Period AB: Difference varenicline versus placebo.||1.32|-0.29|
72456655|NCT00749944|144436329|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.54|||||TWO_SIDED|95.0|-0.17|1.25|||||Mixed Models Analysis included baseline, t (fixed), subject (random), d (fixed), and interaction for t-by-d.|Period AC: Difference varenicline versus placebo.||1.25|-0.17|
72456656|NCT00749944|144436329|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.18|||||TWO_SIDED|95.0|-0.55|0.92|||||Mixed Models Analysis included baseline, t (fixed), subject (random), d (fixed), and interaction for t-by-d.|Period AD: Difference varenicline versus placebo.||0.92|-0.55|
72456657|NCT00749944|144436329|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.26|||||TWO_SIDED|95.0|-0.46|0.99|||||Mixed Models Analysis included baseline, t (fixed), subject (random), d (fixed), and interaction for t-by-d.|Period AE: Difference varenicline versus placebo.||0.99|-0.46|
72456658|NCT00749944|144436329|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.59|||||TWO_SIDED|95.0|-0.19|1.37|||||Mixed Models Analysis included baseline, t (fixed), subject (random), time (fixed), d (fixed), and interactions for t-by-time, t-by-d, time-by-d and t-by-time-by-d.|Period BC: Difference varenicline versus placebo.||1.37|-0.19|
72456659|NCT00749944|144436329|SUPERIORITY_OR_OTHER||Difference (change from baseline)|-0.08|||||TWO_SIDED|95.0|-0.91|0.76|||||Mixed Models Analysis included baseline, t (fixed), subject (random), d (fixed), and interaction for t-by-d.|Period BD: Difference varenicline versus placebo.||0.76|-0.91|
72500218|NCT01478958|144530795|SUPERIORITY_OR_OTHER||||||>|0.05||||||Effect of MUFA-rich diet relative to baseline.|General Linear Model Univariate Analysis|Baseline values for %FMD, BMI and age, gender and intervention diet were used as prognostic factors in the model.||||||>0.05
72500219|NCT01478958|144530795|SUPERIORITY_OR_OTHER||||||>|0.05||||||Effect of n-6 PUFA-rich diet relative to baseline.|General Linear Model Univariate Analysis|Baseline values for %FMD, BMI and age, gender and intervention diet were used as prognostic factors in the model.||||||>0.05
72500220|NCT05003115|144530807|SUPERIORITY||Mean Diff. Adjusting for Baseline Values|-6.36||||0.101|TWO_SIDED|95.0|-14.17|1.44|||Regression, Linear|||||1.44|-14.17|0.101
72500221|NCT05003115|144530808|SUPERIORITY||Mean Diff. Adjusting for Baseline Values|-0.1||||0.78|TWO_SIDED|95.0|-0.79|0.59|||Regression, Linear|||||0.59|-0.79|0.78
72500222|NCT05003115|144530809|SUPERIORITY||Mean Diff. Adjusting for Baseline Values|-0.95||||0.314|TWO_SIDED|95.0|-2.83|0.94|||Regression, Linear|||||0.94|-2.83|0.314
72620759|NCT03992872|144772529|SUPERIORITY|||||||0.5382|||||||Fisher Exact|||"Null hypothesis for analysis of percentage of subjects with Anti-Chikungunya neutralizing activity at or above selected thresholds by time point.~Day 57: Subject with Titer\>=640"||||0.5382
72456660|NCT00749944|144436329|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.1|||||TWO_SIDED|95.0|-0.65|0.85|||||Mixed Models Analysis included baseline, t (fixed), subject (random), d (fixed), and interaction for t-by-d.|Period BE: Difference varenicline versus placebo.||0.85|-0.65|
72456661|NCT00749944|144436330|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.23|||||TWO_SIDED|95.0|-0.2|0.65|||||Mixed Models Analysis included baseline, treatment (t; fixed), subject (random), day (d; fixed), and interaction for t-by-d.|There was no hypothesis testing or power calculation in this study. Period AB: Difference varenicline versus placebo.||0.65|-0.20|
72456662|NCT00749944|144436330|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.21|||||TWO_SIDED|95.0|-0.17|0.58|||||Mixed Models Analysis included baseline, t (fixed), subject (random), d (fixed), and interaction for t-by-d.|Period AC: Difference varenicline versus placebo.||0.58|-0.17|
72456663|NCT00749944|144436330|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.21|||||TWO_SIDED|95.0|-0.23|0.65|||||Mixed Models Analysis included baseline, t (fixed), subject (random), d (fixed), and interaction for t-by-d.|Period AD: Difference varenicline versus placebo.||0.65|-0.23|
72500223|NCT05003115|144530810|SUPERIORITY||Mean Diff. Adjusting for Baseline Values|-1.04||||0.679|TWO_SIDED|95.0|-6.0|3.92|||Regression, Linear|||||3.92|-6.00|0.679
72500224|NCT05003115|144530811|SUPERIORITY||Mean Diff. Adjusting for Baseline Values|0.01||||0.994|TWO_SIDED|95.0|-2.23|2.25|||Regression, Linear|||||2.25|-2.23|0.994
72500225|NCT05003115|144530812|SUPERIORITY||Mean Diff. Adjusting for Baseline Values|-1.22||||0.258|TWO_SIDED|95.0|-3.33|0.89|||Regression, Linear|||||0.89|-3.33|0.258
72500226|NCT05003115|144530813|SUPERIORITY||Mean Diff. Adjusting for Baseline Values|-0.4||||0.857|TWO_SIDED|95.0|-4.75|3.96|||Regression, Linear|||||3.96|-4.75|0.857
72500227|NCT01499290|144530817|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was determined by comparing the lower limit of the 95% confidence interval for risk difference (corresponding to a 97.5% 1-sided lower bound) to the non-inferiority marging of -12.5%|Risk Difference (RD)|-3.5|||||TWO_SIDED|95.0|-8.64|1.58||||||The primary objective of this study (FDA agreed) was to determine the noninferiority in the clinical cure rate for CAZ-AVI compared to that for Meropenem at TOC in the mMITT in adult subjects with cIAI.||1.58|-8.64|
72620760|NCT03992872|144772529|SUPERIORITY|||||||0.4915|||||||Fisher Exact|||"Null hypothesis for analysis of percentage of subjects with Anti-Chikungunya neutralizing activity at or above selected thresholds by time point.~Day 182: Subject with Titer \>= 40"||||0.4915
72456664|NCT00749944|144436330|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.02|||||TWO_SIDED|95.0|-0.37|0.41|||||Mixed Models Analysis included baseline, t (fixed), subject (random), d (fixed), and interaction for t-by-d.|Period AE: Difference varenicline versus placebo.||0.41|-0.37|
72456665|NCT00749944|144436330|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.09|||||TWO_SIDED|95.0|-0.41|0.59|||||Mixed Models Analysis included baseline, t (fixed), subject (random), time (fixed), d (fixed), and interactions for t-by-time, t-by-d, time-by-d and t-by-time-by-d.|Period BC: Difference varenicline versus placebo.||0.59|-0.41|
72456666|NCT00749944|144436330|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.1|||||TWO_SIDED|95.0|-0.44|0.63|||||Mixed Models Analysis included baseline, t (fixed), subject (random), d (fixed), and interaction for t-by-d.|Period BD: Difference varenicline versus placebo.||0.63|-0.44|
72456667|NCT00749944|144436330|SUPERIORITY_OR_OTHER||Difference (change from baseline)|-0.12|||||TWO_SIDED|95.0|-0.58|0.34|||||Mixed Models Analysis included baseline, t (fixed), subject (random), d (fixed), and interaction for t-by-d.|Period BE: Difference varenicline versus placebo.||0.34|-0.58|
72456668|NCT00749944|144436331|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.22|||||TWO_SIDED|95.0|-0.66|1.1|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|There was no hypothesis testing or power calculation in this study. Period AB: Difference varenicline versus placebo.||1.10|-0.66|
72456669|NCT00749944|144436331|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.44|||||TWO_SIDED|95.0|-0.46|1.35|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period AC: Difference varenicline versus placebo.||1.35|-0.46|
72620761|NCT03992872|144772529|SUPERIORITY||||||>|0.9999|||||||Fisher Exact|||"Null hypothesis for analysis of percentage of subjects with Anti-Chikungunya neutralizing activity at or above selected thresholds by time point.~Day 182: Subject with Titer \>= 160"||||>0.9999
72620762|NCT03992872|144772529|SUPERIORITY|||||||0.552|||||||Fisher Exact|||"Null hypothesis for analysis of percentage of subjects with Anti-Chikungunya neutralizing activity at or above selected thresholds by time point.~Day 182: Subject with Titer \>= 640"||||0.5520
72456670|NCT00749944|144436331|SUPERIORITY_OR_OTHER||Difference (change from baseline)|-0.22|||||TWO_SIDED|95.0|-1.16|0.71|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period AD: Difference varenicline versus placebo.||0.71|-1.16|
72456671|NCT00749944|144436331|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.03|||||TWO_SIDED|95.0|-0.68|0.73|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period AE: Difference varenicline versus placebo.||0.73|-0.68|
72456672|NCT00749944|144436331|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.58|||||TWO_SIDED|95.0|-0.79|1.96|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period BC: Difference varenicline versus placebo.||1.96|-0.79|
72456673|NCT00749944|144436331|SUPERIORITY_OR_OTHER||Difference (change from baseline)|-0.43|||||TWO_SIDED|95.0|-1.69|0.82|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period BD: Difference varenicline versus placebo.||0.82|-1.69|
72456674|NCT00749944|144436331|SUPERIORITY_OR_OTHER||Difference (change from baseline)|-0.09|||||TWO_SIDED|95.0|-0.86|0.68|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period BE: Difference varenicline versus placebo.||0.68|-0.86|
72456675|NCT00749944|144436332|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.27|||||TWO_SIDED|95.0|-0.55|1.08|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|There was no hypothesis testing or power calculation in this study. Period AB: Difference varenicline versus placebo.||1.08|-0.55|
72456676|NCT00749944|144436332|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.53|||||TWO_SIDED|95.0|-0.39|1.46|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period AC: Difference varenicline versus placebo.||1.46|-0.39|
72456677|NCT00749944|144436332|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.09|||||TWO_SIDED|95.0|-1.08|1.25|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period AD: Difference varenicline versus placebo.||1.25|-1.08|
72456678|NCT00749944|144436332|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.14|||||TWO_SIDED|95.0|-0.62|0.9|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period AE: Difference varenicline versus placebo.||0.90|-0.62|
72456679|NCT00749944|144436332|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.5|||||TWO_SIDED|95.0|-0.94|1.95|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period BC: Difference varenicline versus placebo.||1.95|-0.94|
72456680|NCT00749944|144436332|SUPERIORITY_OR_OTHER||Difference (change from baseline)|-0.03|||||TWO_SIDED|95.0|-1.57|1.51|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period BD: Difference varenicline versus placebo.||1.51|-1.57|
72620763|NCT03992872|144772530|SUPERIORITY||GMR (Prior Alpha / Naïve Alpha)|1.51||||0.0277|TWO_SIDED|95.0|1.05|2.19||P-values were based on an ANOVA model with log10-transformed titer as the dependent variable and study arm, age, and gender as predictors.|ANOVA||Differences in least squares means from the ANOVA model were back-transformed and reported as geometric mean ratios with 95% confidence intervals.|Day 1: Geometric mean ratio (prior alpha group over naïve alpha group) and 95% confidence interval||2.19|1.05|0.0277
72456681|NCT00749944|144436332|SUPERIORITY_OR_OTHER||Difference (change from baseline)|-0.08|||||TWO_SIDED|95.0|-0.91|0.75|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period BE: Difference varenicline versus placebo.||0.75|-0.91|
72456682|NCT00749944|144436333|SUPERIORITY_OR_OTHER||Difference (change from baseline)|-0.35|||||TWO_SIDED|95.0|-1.76|1.06|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|There was no hypothesis testing or power calculation in this study. Period AB: Difference varenicline versus placebo.||1.06|-1.76|
72456683|NCT00749944|144436333|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.11|||||TWO_SIDED|95.0|-0.96|1.17|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period AC: Difference varenicline versus placebo.||1.17|-0.96|
72456684|NCT00749944|144436333|SUPERIORITY_OR_OTHER||Difference (change from baseline)|1.49|||||TWO_SIDED|95.0|-1.94|4.91|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period AD: Difference varenicline versus placebo.||4.91|-1.94|
72456685|NCT00749944|144436333|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.5|||||TWO_SIDED|95.0|-1.18|2.18|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period AE: Difference varenicline versus placebo.||2.18|-1.18|
72456686|NCT00749944|144436333|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.61|||||TWO_SIDED|95.0|-0.85|2.07|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period BC: Difference varenicline versus placebo.||2.07|-0.85|
72456687|NCT00749944|144436333|SUPERIORITY_OR_OTHER||Difference (change from baseline)|2.1|||||TWO_SIDED|95.0|-2.6|6.79|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period BD: Difference varenicline versus placebo.||6.79|-2.60|
72456688|NCT00749944|144436333|SUPERIORITY_OR_OTHER||Difference (change from baseline)|1.13|||||TWO_SIDED|95.0|-0.7|2.96|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period BE: Difference varenicline versus placebo.||2.96|-0.70|
72456689|NCT00749944|144436334|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.0|||||TWO_SIDED|95.0|-0.26|0.27|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|There was no hypothesis testing or power calculation in this study. Period AB: Difference varenicline versus placebo.||0.27|-0.26|
72456690|NCT00749944|144436334|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.02|||||TWO_SIDED|95.0|-0.25|0.29|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period AC: Difference varenicline versus placebo.||0.29|-0.25|
72456691|NCT00749944|144436334|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.1|||||TWO_SIDED|95.0|-0.37|0.58|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period AD: Difference varenicline versus placebo.||0.58|-0.37|
72456692|NCT00749944|144436334|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.08|||||TWO_SIDED|95.0|-0.17|0.34|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period AE: Difference varenicline versus placebo.||0.34|-0.17|
72456693|NCT00749944|144436334|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.04|||||TWO_SIDED|95.0|-0.4|0.48|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period BC: Difference varenicline versus placebo.||0.48|-0.40|
72456694|NCT00749944|144436334|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.17|||||TWO_SIDED|95.0|-0.44|0.78|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period BD: Difference varenicline versus placebo.||0.78|-0.44|
72456695|NCT00749944|144436334|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.13|||||TWO_SIDED|95.0|-0.14|0.4|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period BE: Difference varenicline versus placebo.||0.40|-0.14|
72456696|NCT00749944|144436337|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.41|||||TWO_SIDED|95.0|-1.09|1.9|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|There was no hypothesis testing or power calculation in this study. Period AB: Difference varenicline versus placebo.||1.90|-1.09|
72456697|NCT00749944|144436337|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.08|||||TWO_SIDED|95.0|-1.54|1.71|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period AC: Difference varenicline versus placebo.||1.71|-1.54|
72456698|NCT00749944|144436337|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.06|||||TWO_SIDED|95.0|-2.47|2.6|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period AD: Difference varenicline versus placebo.||2.60|-2.47|
72456699|NCT00749944|144436337|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.29|||||TWO_SIDED|95.0|-1.57|2.15|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period AE: Difference varenicline versus placebo.||2.15|-1.57|
72456700|NCT00749944|144436337|SUPERIORITY_OR_OTHER||Difference (change from baseline)|-0.94|||||TWO_SIDED|95.0|-2.23|0.36|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period BC: Difference varenicline versus placebo.||0.36|-2.23|
72456701|NCT00749944|144436337|SUPERIORITY_OR_OTHER||Difference (change from baseline)|-0.74|||||TWO_SIDED|95.0|-2.81|1.33|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period BD: Difference varenicline versus placebo.||1.33|-2.81|
72456702|NCT00749944|144436337|SUPERIORITY_OR_OTHER||Difference (change from baseline)|-0.43|||||TWO_SIDED|95.0|-1.78|0.92|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period BE: Difference varenicline versus placebo.||0.92|-1.78|
72456703|NCT00749944|144436338|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.08|||||TWO_SIDED|95.0|-0.04|0.19|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|There was no hypothesis testing or power calculation in this study. Period AB: Difference varenicline versus placebo.||0.19|-0.04|
72456704|NCT00749944|144436338|SUPERIORITY_OR_OTHER||Difference (change from baseline)|-0.01|||||TWO_SIDED|95.0|-0.11|0.08|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period AC: Difference varenicline versus placebo.||0.08|-0.11|
72456705|NCT00749944|144436338|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.02|||||TWO_SIDED|95.0|-0.06|0.09|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period AD: Difference varenicline versus placebo.||0.09|-0.06|
72456706|NCT00749944|144436338|SUPERIORITY_OR_OTHER||Difference (change from baseline)|-0.05|||||TWO_SIDED|95.0|-0.11|0.02|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period AE: Difference varenicline versus placebo.||0.02|-0.11|
72456707|NCT00749944|144436338|SUPERIORITY_OR_OTHER||Difference (change from baseline)|-0.14|||||TWO_SIDED|95.0|-0.27|-0.01|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period BC: Difference varenicline versus placebo.||-0.01|-0.27|
72456708|NCT00749944|144436338|SUPERIORITY_OR_OTHER||Difference (change from baseline)|-0.1|||||TWO_SIDED|95.0|-0.21|0.01|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period BD: Difference varenicline versus placebo.||0.01|-0.21|
72456709|NCT00749944|144436338|SUPERIORITY_OR_OTHER||Difference (change from baseline)|-0.1|||||TWO_SIDED|95.0|-0.17|-0.03|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period BE: Difference varenicline versus placebo.||-0.03|-0.17|
72456710|NCT00749944|144436339|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.05|||||TWO_SIDED|95.0|-0.03|0.12|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|There was no hypothesis testing or power calculation in this study. Period AB: Difference varenicline versus placebo.||0.12|-0.03|
72456711|NCT00749944|144436339|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.0|||||TWO_SIDED|95.0|-0.08|0.09|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period AC: Difference varenicline versus placebo.||0.09|-0.08|
72500228|NCT01499290|144530818|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was determined by comparing the lower limit of the 95% confidence interval for risk difference (corresponding to a 97.5% 1-sided lower bound) to the non-inferiority marging of -12.5%|Risk Difference (RD)|-2.4|||||TWO_SIDED|95.0|-6.9|2.1||||||The co-primary objective of this study (ROW agreed) was to determine the noninferiority in the clinical cure rate for CAZ-AVI compared to that for Meropenem at TOC in the MITT in adult subjects with cIAI.||2.10|-6.90|
72500229|NCT01499290|144530819|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was determined by comparing the lower limit of the 95% confidence interval for risk difference (corresponding to a 97.5% 1-sided lower bound) to the non-inferiority marging of -12.5%|Risk Difference (RD)|-0.8|||||TWO_SIDED|95.0|-4.61|2.89||||||The co-primary objective of this study (ROW agreed) was to determine the noninferiority in the clinical cure rate for CAZ-AVI compared to that for Meropenem at TOC in the CE in adult subjects with cIAI.||2.89|-4.61|
72500230|NCT00327444|144530842|SUPERIORITY_OR_OTHER||Least squares (LS) Mean difference|31.8|STANDARD_ERROR_OF_MEAN|10.59||0.0019|TWO_SIDED|95.0|10.56|53.05||Estimated using Wilcoxon rank-sum test with stratification of baseline paracentesis (=\<2 weeks versus \>2 weeks) at randomization.|ANOVA|Estimated from ANOVA model with stratification of baseline paracentesis (=\<2 weeks versus \>2 weeks).|The LS mean difference is estimated for aflibercept versus placebo (aflibercept-placebo).|||53.05|10.56|0.0019
72620764|NCT03992872|144772530|SUPERIORITY||GMR (Prior Alpha / Naïve Alpha)|1.83||||0.0088|TWO_SIDED|95.0|1.17|2.86||P-values were based on an ANOVA model with log10-transformed titer as the dependent variable and study arm, age, and gender as predictors.|ANOVA||Differences in least squares means from the ANOVA model were back-transformed and reported as geometric mean ratios with 95% confidence intervals.|Day 22: Geometric mean ratio (prior alpha group over naïve alpha group) and 95% confidence interval||2.86|1.17|0.0088
72620765|NCT03992872|144772530|SUPERIORITY||GMR (Prior Alpha / Naïve Alpha)|1.68||||0.0475|TWO_SIDED|95.0|1.01|2.82||P-values were based on an ANOVA model with log10-transformed titer as the dependent variable and study arm, age, and gender as predictors.|ANOVA||Differences in least squares means from the ANOVA model were back-transformed and reported as geometric mean ratios with 95% confidence intervals.|Day 29: Geometric mean ratio (prior alpha group over naïve alpha group) and 95% confidence interval||2.82|1.01|0.0475
72620766|NCT03992872|144772531|SUPERIORITY|||||||1|||||||Fisher Exact|"Day 22.~Note: A subject has a 4-fold rise at a visit if they achieve a titer at that visit that is at least 4-fold higher than their Day 1 titer."||||||1.00
72620767|NCT03992872|144772531|SUPERIORITY|||||||1|||||||Fisher Exact|"Day 29.~Note: A subject has a 4-fold rise at a visit if they achieve a titer at that visit that is at least 4-fold higher than their Day 1 titer."||||||1.00
72456712|NCT00749944|144436339|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.03|||||TWO_SIDED|95.0|-0.04|0.11|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period AD: Difference varenicline versus placebo.||0.11|-0.04|
72456713|NCT00749944|144436339|SUPERIORITY_OR_OTHER||Difference (change from baseline)|-0.01|||||TWO_SIDED|95.0|-0.08|0.05|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period AE: Difference varenicline versus placebo.||0.05|-0.08|
72456714|NCT00749944|144436339|SUPERIORITY_OR_OTHER||Difference (change from baseline)|-0.08|||||TWO_SIDED|95.0|-0.22|0.06|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period BC: Difference varenicline versus placebo.||0.06|-0.22|
72456715|NCT00749944|144436339|SUPERIORITY_OR_OTHER||Difference (change from baseline)|-0.03|||||TWO_SIDED|95.0|-0.14|0.09|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period BD: Difference varenicline versus placebo.||0.09|-0.14|
72456716|NCT00749944|144436339|SUPERIORITY_OR_OTHER||Difference (change from baseline)|-0.05|||||TWO_SIDED|95.0|-0.11|0.02|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period BE: Difference varenicline versus placebo.||0.02|-0.11|
72456717|NCT00749944|144436340|SUPERIORITY_OR_OTHER||Difference (change from baseline)|-0.06|||||TWO_SIDED|95.0|-0.2|0.09|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|There was no hypothesis testing or power calculation in this study. Period AB: Difference varenicline versus placebo.||0.09|-0.20|
72456718|NCT00749944|144436340|SUPERIORITY_OR_OTHER||Difference (change from baseline)|-0.02|||||TWO_SIDED|95.0|-0.15|0.12|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period AC: Difference varenicline versus placebo.||0.12|-0.15|
72456719|NCT00749944|144436340|SUPERIORITY_OR_OTHER||Difference (change from baseline)|-0.05|||||TWO_SIDED|95.0|-0.15|0.04|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period AD: Difference varenicline versus placebo.||0.04|-0.15|
72456720|NCT00749944|144436340|SUPERIORITY_OR_OTHER||Difference (change from baseline)|-0.08|||||TWO_SIDED|95.0|-0.2|0.04|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period AE: Difference varenicline versus placebo.||0.04|-0.20|
72456721|NCT00749944|144436340|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.05|||||TWO_SIDED|95.0|-0.17|0.27|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period BC: Difference varenicline versus placebo.||0.27|-0.17|
72456722|NCT00749944|144436340|SUPERIORITY_OR_OTHER||Difference (change from baseline)|-0.05|||||TWO_SIDED|95.0|-0.21|0.1|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period BD: Difference varenicline versus placebo.||0.10|-0.21|
72456723|NCT00749944|144436340|SUPERIORITY_OR_OTHER||Difference (change from baseline)|-0.05|||||TWO_SIDED|95.0|-0.17|0.07|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period BE: Difference varenicline versus placebo.||0.07|-0.17|
72456724|NCT00749944|144436341|SUPERIORITY_OR_OTHER||Difference (change from baseline|-0.3|||||TWO_SIDED|95.0|-0.58|-0.02|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|There was no hypothesis testing or power calculation in this study. Period AB: Difference varenicline versus placebo.||-0.02|-0.58|
72456725|NCT00749944|144436341|SUPERIORITY_OR_OTHER||Difference (change from baseline|-0.44|||||TWO_SIDED|95.0|-0.69|-0.19|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period AC: Difference varenicline versus placebo.||-0.19|-0.69|
72456726|NCT00749944|144436341|SUPERIORITY_OR_OTHER||Difference (change from baseline|-0.14|||||TWO_SIDED|95.0|-0.47|0.2|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period AD: Difference varenicline versus placebo.||0.20|-0.47|
72456727|NCT00749944|144436341|SUPERIORITY_OR_OTHER||Difference (change from baseline|-0.35|||||TWO_SIDED|95.0|-0.61|-0.09|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period AE: Difference varenicline versus placebo.||-0.09|-0.61|
72456728|NCT00749944|144436341|SUPERIORITY_OR_OTHER||Difference (change from baseline|-0.45|||||TWO_SIDED|95.0|-0.83|-0.07|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period BC: Difference varenicline versus placebo.||-0.07|-0.83|
72456729|NCT00749944|144436341|SUPERIORITY_OR_OTHER||Difference (change from baseline|-0.08|||||TWO_SIDED|95.0|-0.5|0.34|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period BD: Difference varenicline versus placebo.||0.34|-0.50|
72456730|NCT00749944|144436341|SUPERIORITY_OR_OTHER||Difference (change from baseline|-0.27|||||TWO_SIDED|95.0|-0.57|0.02|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period BE: Difference varenicline versus placebo.||0.02|-0.57|
72456731|NCT00749944|144436342|SUPERIORITY_OR_OTHER||Difference (change from baseline)|-0.02|||||TWO_SIDED|95.0|-0.12|0.08|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|There was no hypothesis testing or power calculation in this study. Period AB: Difference varenicline versus placebo.||0.08|-0.12|
72456732|NCT00749944|144436342|SUPERIORITY_OR_OTHER||Difference (change from baseline)|-0.02|||||TWO_SIDED|95.0|-0.12|0.08|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period AC: Difference varenicline versus placebo.||0.08|-0.12|
72456733|NCT00749944|144436342|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.05|||||TWO_SIDED|95.0|-0.04|0.14|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period AD: Difference varenicline versus placebo.||0.14|-0.04|
72620768|NCT03992872|144772532|SUPERIORITY||GMR (Prior Alpha / Naïve Alpha)|45.17|||||TWO_SIDED|||||"P-values were based on an ANOVA model with log10-transformed titer as the dependent variable and study arm, age, and gender as predictors.~P-value = NE~NE = Not estimable due to lack of response."|||"Differences in least squares means from the ANOVA model were back-transformed and reported as geometric mean ratios with 95% confidence intervals.~95% CI \[NE,NE\]~NE = Not estimable due to lack of response."|Day 1: Geometric mean ratio (prior alpha group over naïve alpha group) and 95% confidence interval||||
72456734|NCT00749944|144436342|SUPERIORITY_OR_OTHER||Difference (change from baseline)|-0.01|||||TWO_SIDED|95.0|-0.07|0.04|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period AE: Difference varenicline versus placebo.||0.04|-0.07|
72456735|NCT00749944|144436342|SUPERIORITY_OR_OTHER||Difference (change from baseline)|-0.01|||||TWO_SIDED|95.0|-0.15|0.13|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period BC: Difference varenicline versus placebo.||0.13|-0.15|
72456736|NCT00749944|144436342|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.06|||||TWO_SIDED|95.0|0.01|0.1|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period BD: Difference varenicline versus placebo.||0.10|0.01|
72456737|NCT00749944|144436342|SUPERIORITY_OR_OTHER||Difference (change from baseline)|-0.02|||||TWO_SIDED|95.0|-0.08|0.04|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period BE: Difference varenicline versus placebo.||0.04|-0.08|
72563009|NCT00292227|144658087|NON_INFERIORITY_OR_EQUIVALENCE|A standard deviation of 12ms was assumed for sample size calculation. Sample size was calculated to have 90% power to show the non-inferiority of rotigotine against placebo with respect to the non-inferiority margin of 10ms (α=0.05, 1-sided).|Mean Difference (Net)|-1.17||||||90.0|-3.25|0.91|||ANCOVA|The ANCOVA model included the factors site, treatment, gender, and time-matched baseline QTcI as covariate.|The direction of the estimate is Rotigotine - Placebo. Mean difference was estimated from the ANCOVA model.|The analysis was based on a non-inferiority comparison of rotigotine vs placebo using a 1-sided 95% confidence interval (or, equivalently, the upper limit of 2-sided 90% confidence interval) for the time-matched changes from Baseline in QTcI.||0.91|-3.25|
72620769|NCT03992872|144772532|SUPERIORITY||GMR (Prior Alpha / Naïve Alpha)|47.34|||||TWO_SIDED|||||"P-values were based on an ANOVA model with log10-transformed titer as the dependent variable and study arm, age, and gender as predictors.~P-value = NE NE = Not estimable due to lack of response."|||"Differences in least squares means from the ANOVA model were back-transformed and reported as geometric mean ratios with 95% confidence intervals.~95% CI \[NE,NE\] NE = Not estimable due to lack of response."|Day 22: Geometric mean ratio (prior alpha group over naïve alpha group) and 95% confidence interval||||
72456738|NCT00749944|144436343|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.12|||||TWO_SIDED|95.0|-0.05|0.28|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|There was no hypothesis testing or power calculation in this study. Period AB: Difference varenicline versus placebo.||0.28|-0.05|
72456739|NCT00749944|144436343|SUPERIORITY_OR_OTHER||Difference (change from baseline)|-0.02|||||TWO_SIDED|95.0|-0.19|0.14|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period AC: Difference varenicline versus placebo.||0.14|-0.19|
72456740|NCT00749944|144436343|SUPERIORITY_OR_OTHER||Difference (change from baseline)|-0.04|||||TWO_SIDED|95.0|-0.29|0.22|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period AD: Difference varenicline versus placebo.||0.22|-0.29|
72456741|NCT00749944|144436343|SUPERIORITY_OR_OTHER||Difference (change from baseline)|-0.04|||||TWO_SIDED|95.0|-0.2|0.13|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period AE: Difference varenicline versus placebo.||0.13|-0.20|
72456742|NCT00749944|144436343|SUPERIORITY_OR_OTHER||Difference (change from baseline)|-0.19|||||TWO_SIDED|95.0|-0.4|0.01|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period BC: Difference varenicline versus placebo.||0.01|-0.40|
72456743|NCT00749944|144436343|SUPERIORITY_OR_OTHER||Difference (change from baseline)|-0.16|||||TWO_SIDED|95.0|-0.42|0.1|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period BD: Difference varenicline versus placebo.||0.10|-0.42|
72456744|NCT00749944|144436343|SUPERIORITY_OR_OTHER||Difference (change from baseline)|-0.07|||||TWO_SIDED|95.0|-0.22|8.0|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period BE: Difference varenicline versus placebo.||008|-0.22|
72456745|NCT00749944|144436344|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.4|||||TWO_SIDED|95.0|0.6|3.3|||||Cochran-Mantel-Haenszel|There was no hypothesis testing or power calculation in this study. Period AB: Difference varenicline versus placebo. Subjects' worst scores observed in a given period were compared with the threshold criterion for analysis.||3.3|0.6|
72456746|NCT00749944|144436344|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.8|||||TWO_SIDED|95.0|0.4|1.7|||||Cochran-Mantel-Haenszel|Period AC: Difference varenicline versus placebo. Subjects' worst scores observed in a given period were compared with the threshold criterion for analysis.||1.7|0.4|
72456747|NCT00749944|144436344|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.9|||||TWO_SIDED|95.0|0.4|2.1|||||Cochran-Mantel-Haenszel|Period AD: Difference varenicline versus placebo. Subjects' worst scores observed in a given period were compared with the threshold criterion for analysis.||2.1|0.4|
72456748|NCT00749944|144436344|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.0|||||TWO_SIDED|95.0|0.4|2.2|||||Cochran-Mantel-Haenszel|Period AE: Difference varenicline versus placebo. Subjects' worst scores observed in a given period were compared with the threshold criterion for analysis.||2.2|0.4|
72456749|NCT00749944|144436344|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.7|||||TWO_SIDED|95.0|0.3|1.4|||||Cochran-Mantel-Haenszel|Period BC: Difference varenicline versus placebo. Subjects' worst scores observed in a given period were compared with the threshold criterion for analysis.||1.4|0.3|
72456750|NCT00749944|144436344|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.7|||||TWO_SIDED|95.0|0.3|1.4|||||Cochran-Mantel-Haenszel|Period BD: Difference varenicline versus placebo. Subjects' worst scores observed in a given period were compared with the threshold criterion for analysis.||1.4|0.3|
72456751|NCT00749944|144436344|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.6|||||TWO_SIDED|95.0|0.3|1.4|||||Cochran-Mantel-Haenszel|Period BE: Difference varenicline versus placebo. Subjects' worst scores observed in a given period were compared with the threshold criterion for analysis.||1.4|0.3|
72620770|NCT03992872|144772532|SUPERIORITY||GMR (Prior Alpha / Naïve Alpha)|55.74|||||TWO_SIDED|||||"P-values were based on an ANOVA model with log10-transformed titer as the dependent variable and study arm, age, and gender as predictors.~P-value = NE NE = Not estimable due to lack of response."|||"Differences in least squares means from the ANOVA model were back-transformed and reported as geometric mean ratios with 95% confidence intervals.~95% CI \[NE,NE\] NE = Not estimable due to lack of response."|Day 29: Geometric mean ratio (prior alpha group over naïve alpha group) and 95% confidence interval||||
72620771|NCT03992872|144772534|SUPERIORITY|||||||1|||||||Fisher Exact|"Day 22.~Note: A subject has a 4-fold rise at a visit if they achieve a titer at that visit that is at least 4-fold higher than their Day 1 titer."||||||1.0000
72620772|NCT03992872|144772534|SUPERIORITY|||||||1|||||||Fisher Exact|"Day 29.~Note: A subject has a 4-fold rise at a visit if they achieve a titer at that visit that is at least 4-fold higher than their Day 1 titer."||||||1.0000
72620773|NCT03992872|144772535|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||"Null hypothesis for analysis of percentage of subjects with Anti-VEEV PRNT neutralizing activity at or above selected thresholds by time point.~Day 1: Subject with Titer \>= 40"||||<0.0001
72620774|NCT03992872|144772535|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||"Null hypothesis for analysis of percentage of subjects with Anti-VEEV PRNT neutralizing activity at or above selected thresholds by time point.~Day 1: Subject with Titer \>= 160"||||<0.0001
72456752|NCT00749944|144436345|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.5|||||TWO_SIDED|95.0|0.6|10.4|||||Cochran-Mantel-Haenszel|There was no hypothesis testing or power calculation in this study. Period AC: Difference varenicline versus placebo. Subjects' worst scores observed in a given period were compared with the threshold criterion for analysis.||10.4|0.6|
72456753|NCT00749944|144436345|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.0|||||TWO_SIDED|95.0|0.7|11.8|||||Cochran-Mantel-Haenszel|Period AD: Difference varenicline versus placebo. Subjects' worst scores observed in a given period were compared with the threshold criterion for analysis.||11.8|0.7|
72456754|NCT00749944|144436345|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.4|||||TWO_SIDED|95.0|0.5|3.9|||||Cochran-Mantel-Haenszel|Period AE: Difference varenicline versus placebo. Subjects' worst scores observed in a given period were compared with the threshold criterion for analysis.||3.9|0.5|
72456755|NCT00749944|144436345|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.8|||||TWO_SIDED|95.0|0.4|7.8|||||Cochran-Mantel-Haenszel|Period BC: Difference varenicline versus placebo. Subjects' worst scores observed in a given period were compared with the threshold criterion for analysis.||7.8|0.4|
72456756|NCT00749944|144436345|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.2|||||TWO_SIDED|95.0|0.5|9.2|||||Cochran-Mantel-Haenszel|Period BD: Difference varenicline versus placebo. Subjects' worst scores observed in a given period were compared with the threshold criterion for analysis.||9.2|0.5|
72456757|NCT00749944|144436345|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.2|||||TWO_SIDED|95.0|0.4|3.2|||||Cochran-Mantel-Haenszel|Period BE: Difference varenicline versus placebo. Subjects' worst scores observed in a given period were compared with the threshold criterion for analysis.||3.2|0.4|
72456758|NCT00749944|144436346|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.3|||||TWO_SIDED|95.0|0.5|3.9|||||Cochran-Mantel-Haenszel|Period AC: Difference varenicline versus placebo. Subjects' worst scores observed in a given period were compared with the threshold criterion for analysis.||3.9|0.5|
72456759|NCT00749944|144436346|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.9|||||TWO_SIDED|95.0|0.7|5.3|||||Cochran-Mantel-Haenszel|Period AD: Difference varenicline versus placebo. Subjects' worst scores observed in a given period were compared with the threshold criterion for analysis.||5.3|0.7|
72456760|NCT00749944|144436346|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.8|||||TWO_SIDED|95.0|0.7|4.4|||||Cochran-Mantel-Haenszel|Period AE: Difference varenicline versus placebo. Subjects' worst scores observed in a given period were compared with the threshold criterion for analysis.||4.4|0.7|
72456761|NCT00749944|144436346|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.6|||||TWO_SIDED|95.0|0.5|5.0|||||Cochran-Mantel-Haenszel|Period BC: Difference varenicline versus placebo. Subjects' worst scores observed in a given period were compared with the threshold criterion for analysis.||5.0|0.5|
72456762|NCT00749944|144436346|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.3|||||TWO_SIDED|95.0|0.8|6.8|||||Cochran-Mantel-Haenszel|Period BD: Difference varenicline versus placebo. Subjects' worst scores observed in a given period were compared with the threshold criterion for analysis.||6.8|0.8|
72456763|NCT00749944|144436346|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.1|||||TWO_SIDED|95.0|0.8|5.3|||||Cochran-Mantel-Haenszel|Period BE: Difference varenicline versus placebo. Subjects' worst scores observed in a given period were compared with the threshold criterion for analysis.||5.3|0.8|
72456764|NCT00749944|144436347|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.6|||||TWO_SIDED|95.0|0.5|4.9|||||Cochran-Mantel-Haenszel|There was no hypothesis testing or power calculation in this study. Period AB: Difference varenicline versus placebo. Subjects' worst scores observed in a given period were compared with the threshold criterion for analysis.||4.9|0.5|
72456765|NCT00749944|144436347|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.9|||||TWO_SIDED|95.0|0.4|2.0|||||Cochran-Mantel-Haenszel|Period AC: Difference varenicline versus placebo. Subjects' worst scores observed in a given period were compared with the threshold criterion for analysis.||2.0|0.4|
72456766|NCT00749944|144436347|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.9|||||TWO_SIDED|95.0|0.4|1.8|||||Cochran-Mantel-Haenszel|Period AD: Difference varenicline versus placebo. Subjects' worst scores observed in a given period were compared with the threshold criterion for analysis.||1.8|0.4|
72456767|NCT00749944|144436347|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.8|||||TWO_SIDED|95.0|0.4|1.6|||||Cochran-Mantel-Haenszel|Period AE: Difference varenicline versus placebo. Subjects' worst scores observed in a given period were compared with the threshold criterion for analysis.||1.6|0.4|
72456768|NCT00749944|144436347|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.7|||||TWO_SIDED|95.0|0.3|1.6|||||Cochran-Mantel-Haenszel|Period BC: Difference varenicline versus placebo. Subjects' worst scores observed in a given period were compared with the threshold criterion for analysis.||1.6|0.3|
72456769|NCT00749944|144436347|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.8|||||TWO_SIDED|95.0|0.4|1.8|||||Cochran-Mantel-Haenszel|Period BD: Difference varenicline versus placebo. Subjects' worst scores observed in a given period were compared with the threshold criterion for analysis.||1.8|0.4|
72620775|NCT03992872|144772535|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||"Null hypothesis for analysis of percentage of subjects with Anti-VEEV PRNT neutralizing activity at or above selected thresholds by time point.~Day 1: Subject with Titer \>= 640"||||<0.0001
72456770|NCT00749944|144436347|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.8|||||TWO_SIDED|95.0|0.4|1.7|||||Cochran-Mantel-Haenszel|Period BE: Difference varenicline versus placebo. Subjects' worst scores observed in a given period were compared with the threshold criterion for analysis.||1.7|0.4|
72456771|NCT00749944|144436348|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.9|||||TWO_SIDED|95.0|0.3|2.3|||||Cochran-Mantel-Haenszel|There was no hypothesis testing or power calculation in this study. Period AB: Difference varenicline versus placebo. Subjects' worst scores observed in a given period were compared with the threshold criterion for analysis.||2.3|0.3|
72500231|NCT00327444|144530843|SUPERIORITY_OR_OTHER||Least squares (LS) Mean difference|375.5|STANDARD_ERROR_OF_MEAN|205.99||0.016|TWO_SIDED|95.0|-46.48|797.42||Estimated using Wilcoxon rank-sum test with stratification of baseline paracentesis (=\<2 weeks versus \>2 weeks) at randomization.|ANOVA|Estimated from ANOVA model with stratification of baseline paracentesis (=\<2 weeks versus \>2 weeks).|The LS mean difference was estimated for aflibercept versus placebo (aflibercept-placebo).|||797.42|-46.48|0.0160
72456772|NCT00749944|144436348|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.9|||||TWO_SIDED|95.0|0.4|1.9|||||Cochran-Mantel-Haenszel|Period AC: Difference varenicline versus placebo. Subjects' worst scores observed in a given period were compared with the threshold criterion for analysis.||1.9|0.4|
72456773|NCT00749944|144436348|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.0|||||TWO_SIDED|95.0|0.4|2.2|||||Cochran-Mantel-Haenszel|Period AD: Difference varenicline versus placebo. Subjects' worst scores observed in a given period were compared with the threshold criterion for analysis.||2.2|0.4|
72456774|NCT00749944|144436348|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.1|||||TWO_SIDED|95.0|0.5|2.6|||||Cochran-Mantel-Haenszel|Period AE: Difference varenicline versus placebo. Subjects' worst scores observed in a given period were compared with the threshold criterion for analysis.||2.6|0.5|
72456775|NCT00749944|144436348|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.0|||||TWO_SIDED|95.0|0.5|2.3|||||Cochran-Mantel-Haenszel|Period BC: Difference varenicline versus placebo. Subjects' worst scores observed in a given period were compared with the threshold criterion for analysis.||2.3|0.5|
72456776|NCT00749944|144436348|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.2|||||TWO_SIDED|95.0|0.6|2.7|||||Cochran-Mantel-Haenszel|Period BD: Difference varenicline versus placebo. Subjects' worst scores observed in a given period were compared with the threshold criterion for analysis.||2.7|0.6|
72456777|NCT00749944|144436348|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.2|||||TWO_SIDED|95.0|0.5|2.8|||||Cochran-Mantel-Haenszel|Period BE: Difference varenicline versus placebo. Subjects' worst scores observed in a given period were compared with the threshold criterion for analysis.||2.8|0.5|
72456778|NCT00749944|144436350|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.5|||||TWO_SIDED|95.0|0.0|5.6|||||Cochran-Mantel-Haenszel|There was no hypothesis testing or power calculation in this study. Period AC: Difference varenicline versus placebo. Subjects' worst scores observed in a given period were compared with the threshold criterion for analysis.||5.6|0.0|
72500232|NCT00327444|144530844|SUPERIORITY_OR_OTHER||Least squares (LS) Mean difference|-2.4|STANDARD_ERROR_OF_MEAN|0.94||0.0035|TWO_SIDED|95.0|-4.33|-0.54||Estimated using Wilcoxon rank-sum test with stratification of baseline paracentesis (=\<2 weeks versus \>2 weeks) at randomization.|ANOVA|Estimated from ANOVA model with stratification of baseline paracentesis (=\<2 weeks versus \>2 weeks).|The LS mean difference is estimated for aflibercept versus placebo (aflibercept-placebo).|||-0.54|-4.33|0.0035
72563010|NCT00292227|144658088|NON_INFERIORITY_OR_EQUIVALENCE|A standard deviation of 12ms was assumed for sample size calculation. Sample size was calculated to have 90% power to show the non-inferiority of rotigotine against placebo with respect to the non-inferiority margin of 10ms (α=0.05, 1-sided).|Mean Difference (Net)|1.69||||||90.0|-0.34|3.73|||ANCOVA|The ANCOVA model included the factors site, treatment, gender, and time-matched baseline QTcI as covariate.|The direction of the estimate is Rotigotine - Placebo. Mean difference was estimated from the ANCOVA model.|The analysis was based on a non-inferiority comparison of rotigotine vs placebo using a 1-sided 95% confidence interval (or, equivalently, the upper limit of 2-sided 90% confidence interval) for the time-matched changes from Baseline in QTcI.||3.73|-0.34|
72563011|NCT00292227|144658089|NON_INFERIORITY_OR_EQUIVALENCE|A standard deviation of 12ms was assumed for sample size calculation. Sample size was calculated to have 90% power to show the non-inferiority of rotigotine against placebo with respect to the non-inferiority margin of 10ms (α=0.05, 1-sided).|Mean Difference (Net)|0.31||||||90.0|-1.7|2.32|||ANCOVA|The ANCOVA model included the factors site, treatment, gender, and time-matched baseline QTcI as covariate.|The direction of the estimate is Rotigotine - Placebo. Mean difference was estimated from the ANCOVA model.|The analysis was based on a non-inferiority comparison of rotigotine vs placebo using a 1-sided 95% confidence interval (or, equivalently, the upper limit of 2-sided 90% confidence interval) for the time-matched changes from Baseline in QTcI.||2.32|-1.70|
72620776|NCT03992872|144772535|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||"Null hypothesis for analysis of percentage of subjects with Anti-VEEV PRNT neutralizing activity at or above selected thresholds by time point.~Day 22: Subject with Titer \>= 40"||||<0.0001
72456779|NCT00749944|144436350|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.5|||||TWO_SIDED|95.0|0.0|5.6|||||Cochran-Mantel-Haenszel|Period AD: Difference varenicline versus placebo. Subjects' worst scores observed in a given period were compared with the threshold criterion for analysis.||5.6|0.0|
72370440|NCT00488683|144251631|SUPERIORITY_OR_OTHER||R-square|0.43||||||95.0||||Values from Group 1, 2 and 3 were combined for this analysis.|Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccinations and memory B cells at 12 months of age for the serogroup W-135||||
72456780|NCT00749944|144436350|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.0|||||TWO_SIDED|95.0|0.3|3.6|||||Cochran-Mantel-Haenszel|Period AE: Difference varenicline versus placebo. Subjects' worst scores observed in a given period were compared with the threshold criterion for analysis.||3.6|0.3|
72456781|NCT00749944|144436350|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.5|||||TWO_SIDED|95.0|0.0|5.7|||||Cochran-Mantel-Haenszel|Period BC: Difference varenicline versus placebo. Subjects' worst scores observed in a given period were compared with the threshold criterion for analysis.||5.7|0.0|
72456782|NCT00749944|144436350|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.5|||||TWO_SIDED|95.0|0.0|5.7|||||Cochran-Mantel-Haenszel|Period BD: Difference varenicline versus placebo. Subjects' worst scores observed in a given period were compared with the threshold criterion for analysis.||5.7|0.0|
72456783|NCT00749944|144436350|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.0|||||TWO_SIDED|95.0|0.3|3.7|||||Cochran-Mantel-Haenszel|Period BE: Difference varenicline versus placebo. Subjects' worst scores observed in a given period were compared with the threshold criterion for analysis.||3.7|0.3|
72456784|NCT00749944|144436351|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.1|||||TWO_SIDED|95.0|0.2|23.6|||||Cochran-Mantel-Haenszel|There was no hypothesis testing or power calculation in this study. Period BC: Difference varenicline versus placebo. Subjects' worst scores observed in a given period were compared with the threshold criterion for analysis.||23.6|0.2|
72620777|NCT03992872|144772535|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||"Null hypothesis for analysis of percentage of subjects with Anti-VEEV PRNT neutralizing activity at or above selected thresholds by time point.~Day 22: Subject with Titer \>= 160"||||<0.0001
72456785|NCT00923078|144436367|OTHER||Mean Difference (Net)|2.2|STANDARD_ERROR_OF_MEAN|1.02|<|0.05|TWO_SIDED|95.0|0.17|4.23|||Mixed Models Analysis||contrast calculated as baseline minus Auditory Training|Null hypothesis is that there is no difference between baseline and post-training scores. Linear mixed models tested fixed effects of period (3 levels; baseline, post 4-weeks, post 8 weeks), condition (3 levels; baseline, Auditory Cognitive Training, Visual Cognitive Training) and the period x condition interaction. Final model parameters were selected according to Bayesian Information Criteria. Alpha=.05 (2-sided)||4.23|0.17|<0.05
72456786|NCT00923078|144436367|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.72|STANDARD_ERROR_OF_MEAN|1.02||0.48|TWO_SIDED|95.0|-2.75|1.31|||Mixed Models Analysis||contrast calculated as baseline minus Visual Training|Null hypothesis is that there is no difference between baseline and post-training scores. Linear mixed models tested fixed effects of period (3 levels; baseline, post 4-weeks, post 8 weeks), condition (3 levels; baseline, Auditory Cognitive Training, Visual Cognitive Training) and the period x condition interaction. Final model parameters were selected according to Bayesian Information Criteria. Alpha=.05 (2-sided)||1.31|-2.75|0.48
72456787|NCT00923078|144436367|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.92|STANDARD_ERROR_OF_MEAN|1.02|<|0.01|TWO_SIDED|95.0|-4.95|-0.9|||Mixed Models Analysis||contrast calculated as Auditory Training minus Visual Training|Null hypothesis is that there is no difference between post-training scores in Auditory vs. Visual Cognitive Training conditions. Linear mixed models tested fixed effects of period (3 levels; baseline, post 4-weeks, post 8 weeks), condition (3 levels; baseline, Auditory Cognitive Training, Visual Cognitive Training) and the period x condition interaction. Final model parameters were selected according to Bayesian Information Criteria. Alpha=.05 (2-sided)||-0.90|-4.95|<0.01
72456788|NCT00923078|144436368|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.67|STANDARD_ERROR_OF_MEAN|0.295|<|0.05|TWO_SIDED|95.0|0.08|1.25|||Mixed Models Analysis||contrast calculated as baseline minus Auditory Training|Null hypothesis is that there is no difference between baseline and post-training scores. Linear mixed models tested fixed effects of period (3 levels; baseline, post 4-weeks, post 8 weeks), condition (3 levels; baseline, Auditory Cognitive Training, Visual Cognitive Training) and the period x condition interaction. Final model parameters were selected according to Bayesian Information Criteria. Alpha=.05 (2-sided)||1.25|0.08|<0.05
72456789|NCT00923078|144436368|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.51|STANDARD_ERROR_OF_MEAN|0.295||0.09|TWO_SIDED|95.0|-0.08|1.09|||Mixed Models Analysis||contrast calculated as baseline minus Visual Training|Null hypothesis is that there is no difference between baseline and post-training scores. Linear mixed models tested fixed effects of period (3 levels; baseline, post 4-weeks, post 8 weeks), condition (3 levels; baseline, Auditory Cognitive Training, Visual Cognitive Training) and the period x condition interaction. Final model parameters were selected according to Bayesian Information Criteria. Alpha=.05 (2-sided)||1.09|-0.08|0.09
72456790|NCT00923078|144436368|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.16|STANDARD_ERROR_OF_MEAN|0.295||0.59|TWO_SIDED|95.0|-0.75|0.43|||Mixed Models Analysis||contrast calculated as Auditory Training minus Visual Training|Null hypothesis is that there is no difference between post-training scores in Auditory vs. Visual Cognitive Training conditions. Linear mixed models tested fixed effects of period (3 levels; baseline, post 4-weeks, post 8 weeks), condition (3 levels; baseline, Auditory Cognitive Training, Visual Cognitive Training) and the period x condition interaction. Final model parameters were selected according to Bayesian Information Criteria. Alpha=.05 (2-sided)||0.43|-0.75|0.59
72456791|NCT00923078|144436369|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.03|STANDARD_ERROR_OF_MEAN|0.75|<|0.01|TWO_SIDED|95.0|-3.53|-0.52||Post-test scores following Auditory Cognitive Training as compared to baseline, tested at alpha = 0.05 (uncorrected).|Mixed Models Analysis||contrast calculated as baseline minus Auditory Training|Null hypothesis is that there is no difference between baseline and post-training scores. Linear mixed models tested fixed effects of period (3 levels; baseline, post 4-weeks, post 8 weeks), condition (3 levels; baseline, Auditory Cognitive Training, Visual Cognitive Training) and the period x condition interaction. Final model parameters were selected according to Bayesian Information Criteria. Alpha=.05 (2-sided)||-0.52|-3.53|<0.01
72456792|NCT00923078|144436369|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.45|STANDARD_ERROR_OF_MEAN|0.75||0.01|TWO_SIDED|95.0|-3.95|-0.94||Post-test scores following Visual Cognitive Training as compared to baseline, tested at alpha = 0.05 (uncorrected).|Mixed Models Analysis||contrast calculated as baseline minus Visual Training|Null hypothesis is that there is no difference between baseline and post-training scores. Linear mixed models tested fixed effects of period (3 levels; baseline, post 4-weeks, post 8 weeks), condition (3 levels; baseline, Auditory Cognitive Training, Visual Cognitive Training) and the period x condition interaction. Final model parameters were selected according to Bayesian Information Criteria. Alpha=.05 (2-sided)||-0.94|-3.95|0.01
72469967|NCT01080300|144463899|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.19|STANDARD_ERROR_OF_MEAN|0.072||0.0004|TWO_SIDED|95.0|-0.33|-0.04||P-value for the test of difference of the least square mean change from baseline between Gabapentin ER 1800 mg and placebo group is based on the F-test of Type III analysis.|Based on Van Elteren|Multiplicity addressed by requiring significance for all primary endpoints.|Based on ANCOVA|"Baseline LOCF Average Daily Severity Score at Week 12:~Null hypothesis: no treatment differences relative to placebo in mean change from baseline in average daily severity score of moderate to severe hot flashes at Week 12."||-0.04|-0.33|0.0004
72620778|NCT03992872|144772535|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||"Null hypothesis for analysis of percentage of subjects with Anti-VEEV PRNT neutralizing activity at or above selected thresholds by time point.~Day 22: Subject with Titer \>=640"||||<0.0001
72370441|NCT00488683|144251631|SUPERIORITY_OR_OTHER||R-square|0.82||||||95.0||||Values from Group 1, 2 and 3 were combined for this analysis.|Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccinations and memory B cells at 12 months of age for the serogroup Y||||
72620779|NCT03992872|144772535|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||"Null hypothesis for analysis of percentage of subjects with Anti-VEEV PRNT neutralizing activity at or above selected thresholds by time point.~Day 29: Subject with Titer \>= 40"||||<0.0001
72456793|NCT00923078|144436369|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.42|STANDARD_ERROR_OF_MEAN|0.75||0.58|TWO_SIDED|95.0|-1.93|1.08||Post-test scores following Auditory Cognitive Training as compared to Visual Cognitive Training, tested at alpha = 0.05 (uncorrected).|Mixed Models Analysis||contrast calculated as Auditory Training minus Visual Training|Null hypothesis is that there is no difference between post-training scores in Auditory vs. Visual Cognitive Training conditions. Linear mixed models tested fixed effects of period (3 levels; baseline, post 4-weeks, post 8 weeks), condition (3 levels; baseline, Auditory Cognitive Training, Visual Cognitive Training) and the period x condition interaction. Final model parameters were selected according to Bayesian Information Criteria. Alpha=.05 (2-sided)||1.08|-1.93|0.58
72456794|NCT00923078|144436370|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.92|STANDARD_ERROR_OF_MEAN|1.55||0.06|TWO_SIDED|95.0|-6.02|0.18|||Mixed Models Analysis||contrast calculated as baseline minus Auditory Training|Null hypothesis is that there is no difference between baseline and post-training scores. Linear mixed models tested fixed effects of period (3 levels; baseline, post 4-weeks, post 8 weeks), condition (3 levels; baseline, Auditory Cognitive Training, Visual Cognitive Training) and the period x condition interaction. Final model parameters were selected according to Bayesian Information Criteria. Alpha=.05 (2-sided)||0.18|-6.02|0.06
72456795|NCT00923078|144436370|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.24|STANDARD_ERROR_OF_MEAN|1.55|<|0.05|TWO_SIDED|95.0|-6.34|-0.14|||Mixed Models Analysis||contrast calculated as baseline minus Visual Training|Null hypothesis is that there is no difference between baseline and post-training scores. Linear mixed models tested fixed effects of period (3 levels; baseline, post 4-weeks, post 8 weeks), condition (3 levels; baseline, Auditory Cognitive Training, Visual Cognitive Training) and the period x condition interaction. Final model parameters were selected according to Bayesian Information Criteria. Alpha=.05 (2-sided)||-0.14|-6.34|< 0.05
72456796|NCT00923078|144436370|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.32|STANDARD_ERROR_OF_MEAN|1.55||0.84|TWO_SIDED|95.0|-3.42|2.78|||Mixed Models Analysis||contrast calculated as Auditory Training minus Visual Training|Null hypothesis is that there is no difference between post-training scores in Auditory vs. Visual Cognitive Training conditions. Linear mixed models tested fixed effects of period (3 levels; baseline, post 4-weeks, post 8 weeks), condition (3 levels; baseline, Auditory Cognitive Training, Visual Cognitive Training) and the period x condition interaction. Final model parameters were selected according to Bayesian Information Criteria. Alpha=.05 (2-sided)||2.78|-3.42|0.84
72456797|NCT00923078|144436371|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.62|STANDARD_ERROR_OF_MEAN|1.04||0.55|TWO_SIDED|95.0|-1.45|2.69|||Mixed Models Analysis||contrast calculated as baseline minus Auditory Training|Null hypothesis is that there is no difference between baseline and post-training scores. Linear mixed models tested fixed effects of period (3 levels; baseline, post 4-weeks, post 8 weeks), condition (3 levels; baseline, Auditory Cognitive Training, Visual Cognitive Training) and the period x condition interaction. Final model parameters were selected according to Bayesian Information Criteria. Alpha=.05 (2-sided)||2.69|-1.45|0.55
72456798|NCT00923078|144436371|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.03|STANDARD_ERROR_OF_MEAN|1.03||0.98|TWO_SIDED|95.0|-2.02|2.07|||Mixed Models Analysis||contrast calculated as baseline minus Visual Training|Null hypothesis is that there is no difference between baseline and post-training scores. Linear mixed models tested fixed effects of period (3 levels; baseline, post 4-weeks, post 8 weeks), condition (3 levels; baseline, Auditory Cognitive Training, Visual Cognitive Training) and the period x condition interaction. Final model parameters were selected according to Bayesian Information Criteria. Alpha=.05 (2-sided)||2.07|-2.02|0.98
72456799|NCT00923078|144436371|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.59|STANDARD_ERROR_OF_MEAN|1.04||0.57|TWO_SIDED|95.0|-2.66|1.47|||Mixed Models Analysis||contrast calculated as Auditory Training minus Visual Training|Null hypothesis is that there is no difference between post-training scores in Auditory vs. Visual Cognitive Training conditions. Linear mixed models tested fixed effects of period (3 levels; baseline, post 4-weeks, post 8 weeks), condition (3 levels; baseline, Auditory Cognitive Training, Visual Cognitive Training) and the period x condition interaction. Final model parameters were selected according to Bayesian Information Criteria. Alpha=.05 (2-sided)||1.47|-2.66|0.57
72456800|NCT00923078|144436372|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.6|STANDARD_ERROR_OF_MEAN|1.27||0.63|TWO_SIDED|95.0|-3.14|1.93|||Mixed Models Analysis||contrast calculated as baseline minus Auditory Training|Null hypothesis is that there is no difference between baseline and post-training scores. Linear mixed models tested fixed effects of period (3 levels; baseline, post 4-weeks, post 8 weeks), condition (3 levels; baseline, Auditory Cognitive Training, Visual Cognitive Training) and the period x condition interaction. Final model parameters were selected according to Bayesian Information Criteria. Alpha=.05 (2-sided)||1.93|-3.14|0.63
72456801|NCT00923078|144436372|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.92|STANDARD_ERROR_OF_MEAN|1.27||0.47|TWO_SIDED|95.0|-3.45|1.61|||Mixed Models Analysis||contrast calculated as baseline minus Visual Training|Null hypothesis is that there is no difference between baseline and post-training scores. Linear mixed models tested fixed effects of period (3 levels; baseline, post 4-weeks, post 8 weeks), condition (3 levels; baseline, Auditory Cognitive Training, Visual Cognitive Training) and the period x condition interaction. Final model parameters were selected according to Bayesian Information Criteria. Alpha=.05 (2-sided)||1.61|-3.45|0.47
72456802|NCT00923078|144436372|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.32|STANDARD_ERROR_OF_MEAN|1.27||0.8|TWO_SIDED|95.0|-2.85|2.22|||Mixed Models Analysis||contrast calculated as Auditory Training minus Visual Training|Null hypothesis is that there is no difference between post-training scores in Auditory vs. Visual Cognitive Training conditions. Linear mixed models tested fixed effects of period (3 levels; baseline, post 4-weeks, post 8 weeks), condition (3 levels; baseline, Auditory Cognitive Training, Visual Cognitive Training) and the period x condition interaction. Final model parameters were selected according to Bayesian Information Criteria. Alpha=.05 (2-sided)||2.22|-2.85|0.80
72620780|NCT03992872|144772535|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||"Null hypothesis for analysis of percentage of subjects with Anti-VEEV PRNT neutralizing activity at or above selected thresholds by time point.~Day 29: Subjects with Titer \>= 160"||||<0.0001
72456803|NCT00923078|144436373|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.1|STANDARD_ERROR_OF_MEAN|0.98||0.26|TWO_SIDED|95.0|-3.06|0.85|||Mixed Models Analysis||contrast calculated as baseline minus Auditory Training|Null hypothesis is that there is no difference between baseline and post-training scores. Linear mixed models tested fixed effects of period (3 levels; baseline, post 4-weeks, post 8 weeks), condition (3 levels; baseline, Auditory Cognitive Training, Visual Cognitive Training) and the period x condition interaction. Final model parameters were selected according to Bayesian Information Criteria. Alpha=.05 (2-sided)||0.85|-3.06|0.26
72456804|NCT00923078|144436373|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.47|STANDARD_ERROR_OF_MEAN|0.97||0.13|TWO_SIDED|95.0|-3.41|0.46|||Mixed Models Analysis||contrast calculated as baseline minus Visual Training|Null hypothesis is that there is no difference between baseline and post-training scores. Linear mixed models tested fixed effects of period (3 levels; baseline, post 4-weeks, post 8 weeks), condition (3 levels; baseline, Auditory Cognitive Training, Visual Cognitive Training) and the period x condition interaction. Final model parameters were selected according to Bayesian Information Criteria. Alpha=.05 (2-sided)||0.46|-3.41|0.13
72456805|NCT00923078|144436373|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.37|STANDARD_ERROR_OF_MEAN|0.98||0.71|TWO_SIDED|95.0|-2.32|1.58|||Mixed Models Analysis||contrast calculated as Auditory Training minus Visual Training|Null hypothesis is that there is no difference between post-training scores in Auditory vs. Visual Cognitive Training conditions. Linear mixed models tested fixed effects of period (3 levels; baseline, post 4-weeks, post 8 weeks), condition (3 levels; baseline, Auditory Cognitive Training, Visual Cognitive Training) and the period x condition interaction. Final model parameters were selected according to Bayesian Information Criteria. Alpha=.05 (2-sided)||1.58|-2.32|0.71
72456806|NCT03547154|144436389|SUPERIORITY_OR_OTHER|||||||0.322||||||Analysis of Major Response|Fisher Exact|Missing data considered failures||||||0.322
72456807|NCT03547154|144436390|SUPERIORITY_OR_OTHER||||||>|0.999||||||Analysis of Major Response|Fisher Exact|Missing data considered failures||||||>0.999
72456808|NCT03547154|144436391|SUPERIORITY_OR_OTHER|||||||0.588||||||Analysis of Complete Response|Fisher Exact|Missing data considered failures||||||0.588
72456809|NCT03547154|144436392|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.859|||||TWO_SIDED|95.0|0.429|1.721|||||Overall survival was analyzed using the log-rank statistic. The HR and 95% CI for the HR were obtained using Cox's proportional hazards model.|||1.721|0.429|
72500233|NCT00552110|144530849|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002||95.0||||Multiplicity for multiple treatment comparisons was not adjusted.|ANCOVA|Analysis of Covariance (ANCOVA); classification variables: treatment, center, dosing sequence (stratification variable); covariate: baseline score||"Null hypothesis: the concurrent administration of MFNS and OXY once daily has the same mean change from baseline in AM/PM NOW TNSS as that of OXY twice daily.~Power calculation: The target randomization of 875 subjects (175 subjects per treatment arm) was needed to detect a treatment difference of 0.8 point or more in change from baseline in AM/PM NOW TNSS, with a two-sided alpha of 0.05 and 90% power, assuming a pooled standard deviation of 2.3 points."||||0.002
72563012|NCT00292227|144658090|NON_INFERIORITY_OR_EQUIVALENCE|A standard deviation of 12ms was assumed for sample size calculation. Sample size was calculated to have 90% power to show the non-inferiority of rotigotine against placebo with respect to the non-inferiority margin of 10ms (α=0.05, 1-sided).|Mean Difference (Net)|1.65||||||90.0|-0.65|3.96|||ANCOVA|The ANCOVA model included the factors site, treatment, gender, and time-matched baseline QTcI as covariate.|The direction of the estimate is Rotigotine - Placebo. Mean difference was estimated from the ANCOVA model.|The analysis was based on a non-inferiority comparison of rotigotine vs placebo using a 1-sided 95% confidence interval (or, equivalently, the upper limit of 2-sided 90% confidence interval) for the time-matched changes from Baseline in QTcI.||3.96|-0.65|
72456810|NCT04679675|144436393|SUPERIORITY||Risk Ratio (RR)|1.3||||0.05|TWO_SIDED|95.0|1.23|1.36|||Poisson Regression with GEE|||Primary analysis stratified by screening history. These results are for Screening-Adherent (population):Direct-Mail versus Education analysis.||1.36|1.23|0.05
72456811|NCT04679675|144436393|SUPERIORITY||Risk Ratio (RR)|1.07||||0.05|TWO_SIDED|95.0|1.02|1.12|||Poisson Regression with GEE|||Primary analysis stratified by screening history. These results are for Screening-Adherent (population):Opt-In versus Education analysis.||1.12|1.02|.05
72456812|NCT04679675|144436393|SUPERIORITY||Risk Ratio (RR)|1.9||||0.05|TWO_SIDED|95.0|1.68|2.16|||Poisson Regression with GEE|||Primary analysis stratified by screening history. These results are for Screening-Overdue (population):Direct-Mail versus Education analysis.||2.16|1.68|.05
72456813|NCT04679675|144436393|SUPERIORITY||Risk Ratio (RR)|1.14||||0.05|TWO_SIDED|95.0|1.03|1.25|||Poisson Regression with GEE|||Primary analysis stratified by screening history. These results are for Screening-Unknown (population):Opt-In versus Education analysis.||1.25|1.03|.05
72456814|NCT01543204|144436429|SUPERIORITY_OR_OTHER||Difference|10.0||||0.4505|TWO_SIDED|95.0|-15.97|35.97|||Wald asymptotic test|||||35.97|-15.97|0.4505
72620781|NCT03992872|144772535|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||"Null hypothesis for analysis of percentage of subjects with Anti-VEEV PRNT neutralizing activity at or above selected thresholds by time point.~Day 29 : Subjects with Titer \>=640"||||<0.0001
72620782|NCT03992872|144772536|SUPERIORITY||GMR (Prior Alpha / Naïve Alpha)|23.12|||<|0.0001|TWO_SIDED|95.0|11.54|46.35||P-values were based on an ANOVA model with log10-transformed titer as the dependent variable and study arm, age, and gender as predictors.|ANOVA||Differences in least squares means from the ANOVA model were back-transformed and reported as geometric mean ratios with 95% confidence intervals.|Day 1: Geometric mean ratio (prior alpha group over naïve alpha group) and 95% confidence interval||46.35|11.54|<0.0001
72456815|NCT02449902|144436461|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|||||||<0.0001
72620783|NCT03992872|144772536|SUPERIORITY||GMR (Prior Alpha / Naïve Alpha)|172.51|||<|0.0001|TWO_SIDED|95.0|106.6|279.19||P-values were based on an ANOVA model with log10-transformed titer as the dependent variable and study arm, age, and gender as predictors.|ANOVA||Differences in least squares means from the ANOVA model were back-transformed and reported as geometric mean ratios with 95% confidence intervals.|Day 22: Geometric mean ratio (prior alpha group over naïve alpha group) and 95% confidence interval||279.19|106.60|<0.0001
72456816|NCT02449902|144436462|SUPERIORITY_OR_OTHER|||||||0.0002|TWO_SIDED||||||ANOVA|||||||0.0002
72456817|NCT02449902|144436463|SUPERIORITY_OR_OTHER|||||||0.0017|TWO_SIDED||||||ANCOVA|||||||0.0017
72456818|NCT02449902|144436464|SUPERIORITY_OR_OTHER|||||||0.0002|TWO_SIDED||||||ANCOVA|||||||0.0002
72456819|NCT02449902|144436465|SUPERIORITY_OR_OTHER|||||||0.9951|TWO_SIDED||||||ANOVA|||||||0.9951
72456820|NCT02449902|144436466|SUPERIORITY_OR_OTHER|||||||0.1429|TWO_SIDED||||||Fisher Exact|||||||0.1429
72456821|NCT02449902|144436467|SUPERIORITY_OR_OTHER|||||||0.1945|TWO_SIDED||||||ANCOVA|||||||0.1945
72456822|NCT02449902|144436468|SUPERIORITY_OR_OTHER|||||||0.0001|TWO_SIDED||||||ANCOVA|||||||0.0001
72456823|NCT02449902|144436469|SUPERIORITY_OR_OTHER|||||||0.182|TWO_SIDED||||||ANCOVA|||||||0.1820
72456824|NCT02449902|144436470|SUPERIORITY_OR_OTHER|||||||0.0401|TWO_SIDED||||||ANCOVA|||||||0.0401
72456825|NCT02362789|144436471|SUPERIORITY||Mean Difference (Net)|-18.3||||0.0055|TWO_SIDED|95.0|-31.01|-5.59|||ANCOVA|||||-5.59|-31.01|0.0055
72456826|NCT02684136|144436474|SUPERIORITY||||||<|0.05|||||||ANCOVA|baseline used as covariate||||||<0.05
72456827|NCT02684136|144436475|SUPERIORITY||||||<|0.05||||||baseline used as covariate|ANCOVA|||||||<0.05
72456828|NCT00721734|144436476|SUPERIORITY_OR_OTHER||Slope|-0.607||||0.4114|TWO_SIDED|95.0|-2.129|0.914|||Regression, Linear|||"In order to estimate a possible effect of renal function, the relationship between the clearance of carfilzomib and creatinine clearance (CrCl) was explored using a mixed-effects model that included CrCl.~The slope of the regression of CL as a function of CrCL at Cycle 1, Day 1 was evaluated using a linear regression model that included CrCL as continuous variables (excluding the hemodialysis group)."||0.914|-2.129|0.4114
72456829|NCT00068107|144436511|SUPERIORITY_OR_OTHER|||||||0.01|TWO_SIDED||||||t-test, 2 sided|||eGFR measured pre-study was compared to eGFR during the study||||0.01
72456830|NCT00068107|144436511|SUPERIORITY_OR_OTHER||Average Delay in time to ESRD|166.0|||||TWO_SIDED|95.0|8.4|323.8|||||The average delay in end stage renal disease (ESRD) calculated from the eGFR values and represents the estimated difference in time to ESRD between Relagal administered every 2 weeks and Relagal administered weekly. Units = months|||323.8|8.4|
72456831|NCT03989232|144436526|SUPERIORITY||Treatment difference|-0.23||||0.0003|TWO_SIDED|95.0|-0.36|-0.11|||ANCOVA|||On-treatment without rescue medication observation period: Imputation of missing data was handled by multiple imputation (MI) assuming that missing data were missed at random (MAR). The imputation was performed separately within each treatment group defined by randomised treatment.||-0.11|-0.36|0.0003
72456832|NCT03989232|144436526|SUPERIORITY||Treatment difference|-0.18||||0.0098|TWO_SIDED|95.0|-0.31|-0.04|||ANCOVA|||In-trial observation period: Imputation of missing data was handled by MI assuming that missing data were missed at random. The imputation was performed by imputing missing week 40 data separately within groups defined by randomised treatment and treatment status at week 40.||-0.04|-0.31|0.0098
72456833|NCT02691702|144436574|OTHER|MMRM|Mean Difference (Final Values)|-1.26|STANDARD_ERROR_OF_MEAN|37.24|||TWO_SIDED|90.0|-63.09|60.57|||||Test (Melatonin 0.5 mg PM) Reference (Placebo)|||60.57|-63.09|
72456834|NCT02691702|144436574|OTHER|MMRM|Mean Difference (Final Values)|-27.13|STANDARD_ERROR_OF_MEAN|38.61|||TWO_SIDED|90.0|-91.24|36.97|||||Test (PF-05251749 50 mg AM) Reference (Placebo)|||36.97|-91.24|
72456835|NCT02691702|144436574|OTHER|MMRM|Mean Difference (Final Values)|43.72|STANDARD_ERROR_OF_MEAN|45.72|||TWO_SIDED|90.0|-32.19|119.62|||||Test (PF-05251749 100 mg AM) Reference (Placebo)|||119.62|-32.19|
72456836|NCT02691702|144436574|OTHER|MMRM|Mean Difference (Final Values)|61.48|STANDARD_ERROR_OF_MEAN|40.88|||TWO_SIDED|90.0|-6.38|129.35|||||Test (PF-05251749 200 mg AM) Reference (Placebo)|||129.35|-6.38|
72456837|NCT02691702|144436574|OTHER|MMRM|Mean Difference (Final Values)|125.87|STANDARD_ERROR_OF_MEAN|39.37|||TWO_SIDED|90.0|60.51|191.23|||||Test (PF-05251749 400 mg AM) Reference (Placebo)|||191.23|60.51|
72456838|NCT02691702|144436574|OTHER|MMRM|Mean Difference (Final Values)|156.22|STANDARD_ERROR_OF_MEAN|42.91|||TWO_SIDED|90.0|84.99|227.45|||||Test (PF-05251749 750 mg AM) Reference (Placebo)|||227.45|84.99|
72456839|NCT02691702|144436574|OTHER|MMRM|Mean Difference (Final Values)|51.42|STANDARD_ERROR_OF_MEAN|33.12|||TWO_SIDED|90.0|-3.57|106.41|||||Test (PF-05251749 50 mg PM) Reference (Placebo)|||106.41|-3.57|
72456840|NCT02691702|144436574|OTHER|MMRM|Mean Difference (Final Values)|142.74|STANDARD_ERROR_OF_MEAN|36.13|||TWO_SIDED|90.0|82.76|202.72|||||Test (PF-05251749 200 mg PM) Reference (Placebo)|||202.72|82.76|
72456841|NCT02691702|144436574|OTHER|MMRM|Mean Difference (Final Values)|174.9|STANDARD_ERROR_OF_MEAN|36.01|||TWO_SIDED|90.0|115.11|234.69|||||Test (PF-05251749 500 mg PM) Reference (Placebo)|||234.69|115.11|
72456842|NCT02691702|144436575|OTHER|MMRM|Mean Difference (Final Values)|-71.26|STANDARD_ERROR_OF_MEAN|37.24|||TWO_SIDED|90.0|-133.09|-9.43|||||Test (Melatonin 0.5 mg PM) Reference (Placebo)|||-9.43|-133.09|
72456843|NCT02691702|144436575|OTHER|MMRM|Mean Difference (Final Values)|-12.13|STANDARD_ERROR_OF_MEAN|38.61|||TWO_SIDED|90.0|-76.24|51.97|||||Test (PF-05251749 50 mg AM) Reference (Placebo)|||51.97|-76.24|
72456844|NCT02691702|144436575|OTHER|MMRM|Mean Difference (Final Values)|88.72|STANDARD_ERROR_OF_MEAN|45.72|||TWO_SIDED|90.0|12.81|164.62|||||Test (PF-05251749 100 mg AM) Reference (Placebo)|||164.62|12.81|
72456845|NCT02691702|144436575|OTHER|MMRM|Mean Difference (Final Values)|46.48|STANDARD_ERROR_OF_MEAN|40.88|||TWO_SIDED|90.0|-21.38|114.35|||||Test (PF-05251749 200 mg AM) Reference (Placebo)|||114.35|-21.38|
72456846|NCT02691702|144436575|OTHER|MMRM|Mean Difference (Final Values)|87.3|STANDARD_ERROR_OF_MEAN|39.37|||TWO_SIDED|90.0|21.94|152.66|||||Test (PF-05251749 400 mg AM) Reference (Placebo)|||152.66|21.94|
72456847|NCT02691702|144436575|OTHER|MMRM|Mean Difference (Final Values)|126.22|STANDARD_ERROR_OF_MEAN|42.91|||TWO_SIDED|90.0|54.99|197.45|||||Test (PF-05251749 750 mg AM) Reference (Placebo)|||197.45|54.99|
72456848|NCT02691702|144436575|OTHER|MMRM|Mean Difference (Final Values)|92.36|STANDARD_ERROR_OF_MEAN|35.48|||TWO_SIDED|90.0|33.51|151.21|||||Test (PF-05251749 50 mg PM) Reference (Placebo)|||151.21|33.51|
72456849|NCT02691702|144436575|OTHER|MMRM|Mean Difference (Final Values)|107.29|STANDARD_ERROR_OF_MEAN|36.13|||TWO_SIDED|90.0|47.31|167.27|||||Test (PF-05251749 200 mg AM) Reference (Placebo)|||167.27|47.31|
72456850|NCT02691702|144436575|OTHER|MMRM|Mean Difference (Final Values)|140.61|STANDARD_ERROR_OF_MEAN|37.79|||TWO_SIDED|90.0|77.91|203.3|||||Test (PF-05251749 500 mg AM) Reference (Placebo)|||203.30|77.91|
72456851|NCT02060487|144436586|NON_INFERIORITY|Non-inferiority of sildenafil 20 mg TID versus sildenafil 5 mg TID was to be concluded if the upper limit of the 99.7% confidence interval (CI) for hazard ratio (HR) was less than 2.|Hazard Ratio (HR)|0.68|||||TWO_SIDED|99.7|0.31|1.49|||||Hazard ratio estimated from the Proportional Hazards model, stratified by actual previous PAH treatment and etiology of PAH.|||1.49|0.31|
72456852|NCT02060487|144436586|NON_INFERIORITY|Non-inferiority of sildenafil 80 mg TID vs. sildenafil 5 mg TID was to be concluded if the upper limit of the 99.7% CI for HR was less than 2.|Hazard Ratio (HR)|0.51|||||TWO_SIDED|99.7|0.22|1.21|||||Hazard ratio estimated from the Proportional Hazards model, stratified by actual previous PAH treatment and etiology of PAH.|||1.21|0.22|
72620784|NCT03992872|144772536|SUPERIORITY||GMR (Prior Alpha / Naïve Alpha)|118.45|||<|0.0001|TWO_SIDED|95.0|61.76|227.16||P-values were based on an ANOVA model with log10-transformed titer as the dependent variable and study arm, age, and gender as predictors.|ANOVA||Differences in least squares means from the ANOVA model were back-transformed and reported as geometric mean ratios with 95% confidence intervals.|Day 29: Geometric mean ratio (prior alpha group over naive alpha group) and 95% confidence interval||227.16|61.76|<0.0001
72456853|NCT02060487|144436586|NON_INFERIORITY|Non-inferiority of sildenafil 80 mg TID vs. sildenafil 20 mg TID was to be concluded if the upper limit of the 99.7% CI for HR is less than 2.|Hazard Ratio (HR)|0.74|||||TWO_SIDED|99.7|0.3|1.84|||||Hazard ratio estimated from the Proportional Hazards model, stratified by actual previous PAH treatment and etiology of PAH.|||1.84|0.30|
72456854|NCT02060487|144436587|SUPERIORITY||Hazard Ratio (HR)|0.63||||0.035|TWO_SIDED|99.7|0.33|1.21|||Wald test||Hazard ratio estimated from the Proportional Hazards model, stratified by actual previous PAH treatment and etiology of PAH.|||1.21|0.33|0.035
72456855|NCT02060487|144436587|SUPERIORITY||Hazard Ratio (HR)|0.44|||<|0.001|TWO_SIDED|99.7|0.22|0.89|||Wald test||Hazard ratio estimated from the Proportional Hazards model, stratified by actual previous PAH treatment and etiology of PAH.|||0.89|0.22|<0.001
72456856|NCT02060487|144436587|SUPERIORITY||Hazard Ratio (HR)|0.72||||0.195|TWO_SIDED|99.7|0.34|1.52|||Wald test||Hazard ratio estimated from the Proportional Hazards model, stratified by actual previous PAH treatment and etiology of PAH.|||1.52|0.34|0.195
72456857|NCT02060487|144436588|SUPERIORITY||Least-squares means difference|15.0||||0.0627|TWO_SIDED|95.0|-0.8|30.81|||MMRM|||||30.81|-0.80|0.0627
72456858|NCT02060487|144436588|SUPERIORITY||Least-squares means difference|18.9||||0.0201|TWO_SIDED|95.0|2.99|34.86|||MMRM|||||34.86|2.99|0.0201
72456859|NCT02060487|144436588|SUPERIORITY||Least-squares means difference|3.9||||0.6254|TWO_SIDED|95.0|-11.85|19.68|||MMRM|||||19.68|-11.85|0.6254
72456860|NCT02060487|144436589|SUPERIORITY||Least-squares means difference|21.3||||0.0286|TWO_SIDED|95.0|2.25|40.45|||MMRM|||||40.45|2.25|0.0286
72456861|NCT02060487|144436589|SUPERIORITY||Least-squares means difference|20.5||||0.0364|TWO_SIDED|95.0|1.3|39.65|||MMRM|||||39.65|1.30|0.0364
72456862|NCT02060487|144436589|SUPERIORITY||Least-squares means difference|-0.9||||0.9283|TWO_SIDED|95.0|-19.94|18.19|||MMRM|||||18.19|-19.94|0.9283
72456863|NCT00824408|144436641|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.045||||0.003|TWO_SIDED|95.0|1.271|3.292|||Log Rank|||Hazard ratio and 95% confidence interval (CI) from Cox proportional-hazards regression model, stratified by histology (Nonsquamous vs. NOS). P-value from log-rank test stratified by histology (one-sided for volasertib 300 mg + pemetrexed 500 mg/m2 vs. pemetrexed 500 mg; two-sided for volasertib 300 mg vs. pemetrexed 500 mg/m2).||3.292|1.271|0.0030
72456864|NCT00824408|144436641|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.141||||0.2804|TWO_SIDED|95.0|0.735|1.771|||Log Rank|||Hazard ratio and 95% CI from Cox proportional-hazards regression model, stratified by histology (Nonsquamous vs. NOS). P-value from log-rank test stratified by histology (one-sided for volasertib 300 mg + pemetrexed 500 mg/m2 vs. pemetrexed 500 mg/m2; two-sided for volasertib 300 mg vs. pemetrexed 500 mg/m2).||1.771|0.735|0.2804
72563013|NCT00292227|144658091|NON_INFERIORITY_OR_EQUIVALENCE|A standard deviation of 12ms was assumed for sample size calculation. Sample size was calculated to have 90% power to show the non-inferiority of rotigotine against placebo with respect to the non-inferiority margin of 10ms (α=0.05, 1-sided).|Mean Difference (Net)|-0.21||||||90.0|-1.78|1.36|||ANCOVA|The ANCOVA model included the factors site, treatment, gender, and time-matched baseline QTcI as covariate.|The direction of the estimate is Rotigotine - Placebo. Mean difference was estimated from the ANCOVA model.|The analysis was based on a non-inferiority comparison of rotigotine vs placebo using a 1-sided 95% confidence interval (or, equivalently, the upper limit of 2-sided 90% confidence interval) for the time-matched changes from Baseline in QTcI.||1.36|-1.78|
72620785|NCT03992872|144772537|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|"Day 22.~Note: A subject has a 4-fold rise at a visit if they achieve a titer at that visit that is at least 4-fold higher than their Day 1 titer."||||||<0.0001
72456865|NCT00824408|144436642|SUPERIORITY_OR_OTHER||||||>|0.9999|||||||Fisher Exact|||||||>0.9999
72456866|NCT00824408|144436642|SUPERIORITY_OR_OTHER|||||||0.2596|||||||Fisher Exact|||||||0.2596
72456867|NCT00824408|144436643|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.073||||0.8406|TWO_SIDED|95.0|0.538|2.14|||Log Rank|||||2.140|0.538|0.8406
72456868|NCT00824408|144436643|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.081||||0.396|TWO_SIDED|95.0|0.599|1.949|||Log Rank|||||1.949|0.599|0.3960
72456869|NCT03292692|144436654|SUPERIORITY||Slope|0.372|||<|0.001|TWO_SIDED|95.0|0.279|0.465|||Regression, Linear|Multi-level regression|Slope of intervention group compared to slope of the control group|||0.465|0.279|<0.001
72456870|NCT03292692|144436655|SUPERIORITY||Slope|0.17|||<|0.001|TWO_SIDED|95.0|0.105|0.235|||Regression, Linear|Multilevel linear modeling|Slope of the intervention group compared to slope of the control group|||0.235|0.105|<0.001
72456871|NCT03292692|144436656|SUPERIORITY||Mean Difference (Final Values)|-2.149|||<|0.001|TWO_SIDED|95.0|-2.974|-1.324|||Regression, Linear|Multilevel linear regression|Multilevel linear modeling, with time modeled as change from pre-post.|||-1.324|-2.974|<0.001
72456872|NCT03292692|144436657|SUPERIORITY||Mean Difference (Final Values)|-1.144||||0.002|TWO_SIDED|95.0|-1.871|-0.417|||Regression, Linear||Multilevel linear modeling, with time modeled as change from pre to post.|||-0.417|-1.871|0.002
72456873|NCT01075152|144436684|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.73||||0.03|TWO_SIDED|95.0|1.06|2.82||A Lan-DeMets spending function analog of the O'Brien-Fleming boundaries was proposed to control the type-I error resulting from multiple interim analyses.|Regression, Cox||Hazard Ratio describes the risk of earlier HIV therapy in comparison to deferred HIV therapy initiation as the reference group.|"We compared the randomization arms for the primary endpoint of survival using time-to-event methods of Cox proportional hazards models by the intention-to-treat principle, based on two-sided type-I error with alpha=0.05.~The trial was statistically powered to detect a 25% relative survival benefit (15% absolute benefit) with 90% power and overall two-sided alpha=0.05 with an intended sample size of 500 participants. The trial was halted early by the Data and Safety Monitoring Board."||2.82|1.06|0.03
72456874|NCT01075152|144436685|SUPERIORITY_OR_OTHER_LEGACY|||||||0.32|||||||Gray's method of cumulative incidence|||To account for the competing risk of death, the cumulative incidence function compared the randomized groups for endpoints of IRIS, relapse, and adverse events (Gray's method).||||0.32
72456875|NCT01075152|144436686|SUPERIORITY_OR_OTHER_LEGACY|||||||0.06|||||||Gray's method of cumulative incidence|||To account for the competing risk of death, the cumulative incidence function compared the randomized groups for endpoints of IRIS, relapse, and adverse events (Gray's method).||||0.06
72456876|NCT01075152|144436687|SUPERIORITY_OR_OTHER_LEGACY|||||||0.98|||||||Fisher Exact|||Categorical secondary endpoints were compared with Fisher's exact tests.||||0.98
72456877|NCT01075152|144436688|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.66||||0.04|TWO_SIDED|95.0|1.03|2.68|||Regression, Cox|||We compared the randomization arms for survival using time-to-event methods of Cox proportional hazards models.||2.68|1.03|0.04
72456878|NCT01075152|144436689|SUPERIORITY_OR_OTHER_LEGACY|||||||0.26|||||||Fisher Exact|||Categorical secondary endpoints were compared with Fisher's exact tests.||||0.26
72456879|NCT01075152|144436690|SUPERIORITY_OR_OTHER_LEGACY|||||||0.23|||||||Fisher Exact|||Categorical secondary endpoints were compared with Fisher's exact tests.||||0.23
72456880|NCT01075152|144436691|SUPERIORITY_OR_OTHER_LEGACY|||||||0.34|||||||repeated measure analysis|||The overall change from baseline in Karnofsky performance status scores was compared between groups via a repeated measure analysis, unstructured covariance matrix, adjusted for baseline value.||||0.34
72456881|NCT01075152|144436692|SUPERIORITY_OR_OTHER_LEGACY|||||||0.44|||||||Regression, Linear|a linear mixed effects regression model fit with a random intercept and slope estimated the rate of clearance||To describe early fungicidal activity, a linear mixed effects regression model fit with a random intercept and slope estimated the rate of clearance of log10 colony forming units (CFU) of Cryptococcus, per mL of CSF per day, for all participants with \>2 cultures obtained.||||0.44
72456882|NCT01075152|144436693|SUPERIORITY_OR_OTHER_LEGACY|||||||0.02||||||This is the interaction p-value for CSF white cell count at randomization (implying there is a statistical difference in the outcome by arm based on this parameter).|Regression, Cox|||Pre-specified subgroups formed by baseline characteristics were compared for 26 week survival with models including an interaction term between treatment arm and subgroup.||||0.02
72456883|NCT01523392|144436694|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-183.6|STANDARD_ERROR_OF_MEAN|14.68|<|0.001|TWO_SIDED|95.0|-213.9|-153.3||Model contained treatment group, period, and sequence as fixed effects and a random effect for patient within sequence|Mixed Models Analysis||Ticagrelor minus clopidogrel|||-153.3|-213.9|<0.001
72456884|NCT01523392|144436695|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-103.8|STANDARD_ERROR_OF_MEAN|18.79|<|0.001|TWO_SIDED|95.0|-142.5|-65.0|||Mixed Models Analysis|Model contained treatment group, period, and sequence as fixed effects, and a random effect for participant within sequence|Ticagrelor minus clopidogrel|Analysis at 0.5 hours after loading dose||-65.0|-142.5|<0.001
72456885|NCT01523392|144436695|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-165.3|STANDARD_ERROR_OF_MEAN|15.45|<|0.001|TWO_SIDED|95.0|-197.4|-133.3|||Mixed Models Analysis|Model contained treatment group, period, and sequence as fixed effects, and a random effect for participant within sequence|Ticagrelor minus clopidogrel|Analysis at 8 hours after loading dose||-133.3|-197.4|<0.001
72456886|NCT01523392|144436696|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-135.0|STANDARD_ERROR_OF_MEAN|12.35|<|0.001|TWO_SIDED|95.0|-160.4|-109.5|||Mixed Models Analysis|Model contained treatment group, period, and sequence as fixed effects, and a random effect for participant within sequence|Ticagrelor minus clopidogrel|Analysis at 2 hours on Day 7 after multiple doses||-109.5|-160.4|<0.001
72456887|NCT01523392|144436696|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-118.1|STANDARD_ERROR_OF_MEAN|12.55|<|0.001|TWO_SIDED|95.0|-143.9|-92.2|||Mixed Models Analysis|Model contained treatment group, period, and sequence as fixed effects, and a random effect for participant within sequence|Ticagrelor minus clopidogrel|Analysis at 8 hours on Day 7 after multiple doses||-92.2|-143.9|<0.001
72456888|NCT01523392|144436696|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-133.4|STANDARD_ERROR_OF_MEAN|12.77|<|0.001|TWO_SIDED|95.0|-159.7|-107.1|||Mixed Models Analysis|Model contained treatment group, period, and sequence as fixed effects, and a random effect for participant within sequence|Ticagrelor minus clopidogrel|Analysis at end of dosing interval on Day 8||-107.1|-159.7|<0.001
72456889|NCT02236611|144436707|NON_INFERIORITY_OR_EQUIVALENCE|Alternate hypothesis: the difference between the trt means (umeclidinium minus glycopyrronium) would be \> -50 milliliters (mL). If the lower CI (2.5% 1-sided significance level) of the statistical test should fall above -50 mL, then umeclidinium may be deemed statistically non-inferior to glycopyrronium. If the lower CI (2.5% 1-sided significance) of the statistical testing exceeded 0 then, umeclidinium may be deemed statistically superior to glycopyrronium.|Mean Difference (Final Values)|0.024||||0.1|TWO_SIDED|95.0|-0.005|0.054|||Mixed Models Analysis|||||0.054|-0.005|0.100
72500234|NCT00552110|144530849|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||ANCOVA|||Null hypothesis: the concurrent administration of MFNS and OXY once daily has the same mean change from baseline in AM/PM NOW TNSS as that of OXY twice daily.||||<0.001
72620786|NCT03992872|144772537|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|"Day 29~Note: A subject has a 4-fold rise at a visit if they achieve a titer at that visit that is at least 4-fold higher than their Day 1 titer."||||||<0.0001
72500235|NCT00552110|144530849|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||ANCOVA|||Null hypothesis: the administration of MFNS once daily has the same mean change from baseline in AM/PM NOW TNSS as that of placebo.||||<0.001
72620787|NCT03707821|144772539|NON_INFERIORITY|A non-inferiority margin of -5 points was used. This margin is based on a 10% shift in the distribution of CLUE scores. Non-inferiority was declared in the lower limit of the 95% credible interval was above 5.|Mean Difference (Net)|3.3|STANDARD_DEVIATION|2.65|||TWO_SIDED|95.0|-2.0|8.5|||Bayesian normal random-effects|A 95% Credible Interval for the Posterior mean difference between the Test and Control was used to test for non-inferiority.|Mean difference was calculated as Test minus Control.|It was calculated that 224 participants randomized in a 1:1 fashion between the two lens types would have at least 80% power to detect a 5 points difference in mean overall comfort at he 2-week follow-up. Sample size was determined using Stroup's Method (alpha=0.05).||8.5|-2.0|
72370442|NCT00488683|144251631|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|0.05||||0.68||95.0||||Values from Group 1, 2 and 2 were combined for this analysis.|Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccinations and serogroup specific IgG concentration at 12 months of age for the serogroup A||||0.68
72456890|NCT00308308|144436724|NON_INFERIORITY_OR_EQUIVALENCE|Sample size was set to meet regulatory requirement of 250 subjects per arm with 52-week data, resulting in \> 90% power for a non-inferiority test of the difference in 12-month change of HbA1c scores between treatment groups with non-inferiority margin of 0.4%, standard deviation of 1.2 and 1-sided alpha of 0.025. Allowing for a 15% dropout rate, 589 subjects were randomized.|Mean Difference (Final Values)|0.24|STANDARD_ERROR_OF_MEAN|0.082|||TWO_SIDED|95.0|0.08|0.4|||ANCOVA|||||0.40|0.08|
72456891|NCT00308308|144436725|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.8|STANDARD_ERROR_OF_MEAN|0.42|<|0.0001||95.0|-2.7|-1.0|||ANCOVA|||ANCOVA model with terms of pooled site and treatment as fixed effects and baseline weight as covariate||-1.0|-2.7|<0.0001
72456892|NCT00308308|144436726|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-20.9|STANDARD_ERROR_OF_MEAN|7.41||0.0052|TWO_SIDED|95.0|-35.4|-6.3|||ANCOVA|||||-6.3|-35.4|0.0052
72456893|NCT00308308|144436727|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.941||||0.8311|TWO_SIDED|95.0|0.536|1.652|||Regression, Logistic|||logistic regression analysis with the terms of treatment and baseline HbA1c in the model||1.652|0.536|0.8311
72456894|NCT00308308|144436728|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.488||||0.0124|TWO_SIDED|95.0|0.278|0.856|||Regression, Logistic||Model: Treatment + Site|||0.856|0.278|0.0124
72500236|NCT00552110|144530850|SUPERIORITY_OR_OTHER_LEGACY|||||||0.021||95.0||||Multiplicity for multiple treatment comparisons was not adjusted.|ANCOVA|ANCOVA; classification variables: treatment, center, dosing sequence (stratification variable); covariate: baseline score||Null hypothesis: the concurrent administration of MFNS and OXY once daily has the same standardized AUC(0-4 hr) of the change from baseline in nasal congestion score as that of MFNS once daily.||||0.021
72500237|NCT00552110|144530850|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||ANCOVA|||Null hypothesis: the concurrent administration of MFNS and OXY once daily has the same standardized AUC (0-4hr) of the change from baseline in nasal congestion score as that of MFNS once daily||||<0.001
72500238|NCT00552110|144530850|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||ANCOVA|||Null hypothesis: the administration of OXY twice daily has the same standardized AUC(0-4 hr) of the change from baseline in nasal congestion score as that of placebo||||<0.001
72500239|NCT03263091|144530877|OTHER||Odds Ratio (OR)|1.582||||0.217|TWO_SIDED|95.0|0.761|3.29|||Cochran-Mantel-Haenszel|||The odds ratio along with its 95% confidence interval (CI) were calculated based on the Cochran-Mantel-Haenszel (CMH) chi-square test adjusting for the stratification factors (EPO level, International Prognostic Scoring System - Revised \[IPSS-R\] risk category and RBC transfusion burden).||3.290|0.761|0.217
72456895|NCT00308308|144436729|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.825||||0.2786|TWO_SIDED|95.0|0.582|1.169|||Regression, Logistic||Model: Treatment + Site|||1.169|0.582|0.2786
72456896|NCT00308308|144436730|SUPERIORITY_OR_OTHER|||||||0.1193|||||||Generalized Estimation Equation|"* Based on Poisson distribution~* Model: Treatment + Time Period"||||||0.1193
72456897|NCT00308308|144436731|SUPERIORITY_OR_OTHER|||||||0.2131|||||||Generalized Estimating Equation|"* Based on Poisson distribution~* Model: Treatment + Time Period"||||||0.2131
72456898|NCT01802333|144436732|OTHER|||||||0.84|||||||Regression, Cox|Adjusted for: Age (\< 40 vs. \>= 40) and Onset of AML (de novo vs. treatment related and/or AML arising from antecedent hematologic disease)||Arm I was compared with Arm III using a two-sided test of the null hypothesis (HR=1) at the 0.045 level.||||0.84
72500240|NCT00318292|144530910|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.9||||0.003||95.0|-3.2|-0.7|||t-test, 2 sided|||||-0.7|-3.2|.003
72500241|NCT00824564|144530917|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-55.5|STANDARD_ERROR_OF_MEAN|58.63||0.348|TWO_SIDED|95.0|-172.7|61.7|||t-test, 2 sided|||The mean difference with associated standard error (SE), and corresponding 95% confidence interval (CI) for the comparisons of tranexamic acid plus standard of care against Standard of care was presented along with the p-value for the test. Two-sample t-test was performed at 5% level of significance.||61.7|-172.7|0.348
72500242|NCT00824564|144530918|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|24.0|STANDARD_ERROR_OF_MEAN|32.78||0.466|TWO_SIDED|95.0|-41.3|89.3|||t-test, 2 sided|||The mean difference with associated SE and corresponding 95% CI for the comparisons of tranexamic acid plus standard of care against Standard of care was presented along with the p-value for the test. Two-sample t-test was performed at 5% level of significance.||89.3|-41.3|0.466
72500243|NCT00824564|144530919|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.3|STANDARD_ERROR_OF_MEAN|5.57||0.109|TWO_SIDED|95.0|-20.7|2.2|||t-test, 2 sided|||For 1 hour post-surgery, the mean difference with associated SE and corresponding 95% CI for the comparisons of tranexamic acid plus standard of care against Standard of care was presented along with the p-value for the test. Two-sample t-test was performed at 5% level of significance.||2.2|-20.7|0.109
72456899|NCT01802333|144436732|OTHER|||||||0.42|||||||Regression, Cox|Adjusted for: Age (\< 40 vs. \>= 40) and Onset of AML (de novo vs. treatment related and/or AML arising from antecedent hematologic disease)||Arm II was compared with Arm III using a two-sided test of the null hypothesis (HR=1) at the 0.045 level.||||0.42
72456900|NCT01802333|144436733|OTHER||||||<|0.0001|||||||Exact binomial test, 1-sided|||||||<0.0001
72456901|NCT01802333|144436735|OTHER|||||||0.52|||||||Regression, Cox|Adjusted for: Age (\< 40 vs. \>= 40) and Onset of AML (de novo vs. treatment related and/or AML arising from antecedent hematologic disease)||Arm I was compared with Arm II using a two-sided test of the null hypothesis (HR=1).||||0.52
72456902|NCT01947491|144436743|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
72456903|NCT03137784|144436752|OTHER|Treatment difference|Linear Mixed Model (LMM)|0.089|||<|0.001|TWO_SIDED|95.0|0.047|0.132|||Linear Mixed Model|||||0.132|0.047|<0.001
72456904|NCT03137784|144436752|OTHER||Linear Mixed Model (LMM)|0.09|||<|0.001|TWO_SIDED|95.0|0.047|0.132|||Linear Mixed Model|||||0.132|0.047|<0.001
72500244|NCT00824564|144530919|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.8|STANDARD_ERROR_OF_MEAN|3.24||0.045|TWO_SIDED|95.0|-13.4|-0.1|||t-test, 2 sided|||For 4 hour post-surgery, the mean difference with associated SE, and corresponding 95% CI for the comparisons of tranexamic acid plus standard of care against Standard of care was presented along with the p-value for the test. Two-sample t-test was performed at 5% level of significance.||-0.1|-13.4|0.045
72456905|NCT03137784|144436753|OTHER|Treatment difference|Linear Mixed Model (LMM)|0.165|||<|0.001|TWO_SIDED|95.0|0.127|0.203|||Linear Mixed Model|||||0.203|0.127|<0.001
72456906|NCT03137784|144436753|OTHER|Treatment difference|Linear Mixed Model (LMM)|0.168|||<|0.001|TWO_SIDED|95.0|0.129|0.206|||Linear Mixed Model|||||0.206|0.129|<0.001
72620788|NCT03707821|144772540|NON_INFERIORITY|A cumulative odds ratio non-inferiority margin of 2 was used. This margin is based on a 10% difference if the proportion of subjects that report a higher rating/experience.|Mean Difference (Final Values)|0.08|STANDARD_DEVIATION|0.034|||TWO_SIDED|95.0|0.02|0.15|||Bayesian random -effects model|A 95% Credible Interval for the Posterior proportion mean difference between the Test and Control was used to test for non-inferiority.|mean difference was calculated as Test minus Control.|It was calculated that 40 participants randomized in a 1:1 fashion between the two lens types would have at least 80% power to detect a 10% difference in proportion of subjects that reported at higher rating (Strongly Agree and Agree) with the Test compared to the Control lens at the 2-week follow-up. Sample size was determined using simulation-based methods (alpha=0.05).||0.15|0.02|
72620789|NCT03707821|144772541|NON_INFERIORITY|A non-inferiority margin of 0.05 points was used. This margin corresponds to a half line difference.|Mean Difference (Final Values)|-0.03|STANDARD_DEVIATION|0.008|||TWO_SIDED|95.0|-0.04|-0.01|||Bayesian Normal Random effects model|A 95% Credible Interval for the Posterior mean difference between the Test and control was used to test for non-inferiority.|Mean difference was calculated as Test minus Control.|It was calculated that 30 participants randomized in a 1:1 fashion between the two lens types would have at least 80% power to detect a 0.05 difference in LogMAR visual acuity at the 2-week follow-up. Sample size was determined using simulations methods for repeated measures.||-0.01|-0.04|
72620790|NCT03707821|144772542|SUPERIORITY|A superiority margin of 90% was used. Lower limit of 95% credible interval was compared to 90%|Mean Percentage of Acceptable Fitting|99.5|STANDARD_DEVIATION|0.38|||TWO_SIDED|95.0|98.5|100.0|||Bayesian Beta-Binomial Model|model for correlated data||It was calculated that 100 participants were required to show that the acceptable lens fitting for the Test lens would be superior to 90% with at least 80% power. Sample size was determined using simulations methods for repeated measures.||100|98.5|
72620791|NCT03707821|144772543|NON_INFERIORITY|A non-inferiority margin of 5% was used. Upper limit of the 95% credible interval was compared to 5%|Mean Difference (Final Values)|0.0|STANDARD_DEVIATION|0.0036|||TWO_SIDED|95.0|-0.007|0.008|||Bayesian beta-binomial model|model for correlated data|mean difference was calculated as Test minus Control.|It was calculated that 224 participants randomized in a 1:1 fashion between the two lens types would have at least 80% power to detect 5% difference between the Test and Control lens with respect to the proportion of eyes with Grade 3 or higher slit lamp findings across all study visits. Sample size was determined using simulations methods. Sample size for this study was primarily driven by the slit lamp findings.||0.008|-0.007|
72620792|NCT03707821|144772544|NON_INFERIORITY|A non-inferiority margin of -5 points was used. This margin is based on a 10% shift in the distribution of CLUE scores. Non-inferiority was declared in the lower limit of the 95% credible interval was above 5.|Mean Difference (Net)|2.5|STANDARD_DEVIATION|1.94|||TWO_SIDED|95.0|-1.3|6.3|||Bayesian normal random-effects|A 95% Credible Interval for the Posterior mean difference between the Test and Control was used to test for non-inferiority.|Mean difference was calculated as Test minus Control.|Sample Size was based on primary endpoints only.||6.3|-1.3|
72456907|NCT03137784|144436754|OTHER|Treatment difference|Linear Mixed Model (LMM)|0.176|||<|0.001|TWO_SIDED|95.0|0.141|0.212|||Linear Mixed Model|||||0.212|0.141|<0.001
72456908|NCT03137784|144436754|OTHER|Treatment difference|Linear Mixed Model (LMM)|0.179|||<|0.001|TWO_SIDED|95.0|0.144|0.215|||Linear Mixed Model|||||0.215|0.144|<0.001
72456909|NCT03137784|144436755|OTHER|Treatment difference|Linear Mixed Model (LMM)|0.139|||<|0.001|TWO_SIDED|95.0|0.106|0.173|||Linear Mixed Model|||||0.173|0.106|<0.001
72456910|NCT03137784|144436755|OTHER|Treatment difference|Linear Mixed Model (LMM)|0.146|||<|0.001|TWO_SIDED|95.0|0.112|0.179|||Linear Mixed Model|||||0.179|0.112|<0.001
72456911|NCT03137784|144436756|OTHER|Treatment difference|Linear Mixed Model (LMM)|0.164|||<|0.001|TWO_SIDED|95.0|0.127|0.201|||Linear Mixed Model|||||0.201|0.127|<0.001
72456912|NCT03137784|144436756|OTHER|Treatment difference|Linear Mixed Model (LMM)|0.174|||<|0.001|TWO_SIDED|95.0|0.137|0.211|||Linear Mixed Model|||||0.211|0.137|<0.001
72456913|NCT03137784|144436757|OTHER|Treatment difference|Linear Mixed Model (LMM)|0.036||||0.079|TWO_SIDED|95.0|-0.004|0.077|||Linear Mixed Model|||||0.077|-0.004|0.079
72456914|NCT03137784|144436757|OTHER|Treatment difference|Linear Mixed Model (LMM)|0.058||||0.006|TWO_SIDED|95.0|0.017|0.099|||Linear Mixed Model|||||0.099|0.017|0.006
72456915|NCT03137784|144436759|OTHER|Treatment difference|Linear Mixed Model (LMM)|25.51|||<|0.001|TWO_SIDED|95.0|19.22|31.79|||Linear Mixed Model||LS Mean of change from baseline in mean morning PEF is calculated with the ANCOVA model using treatment, stratification group, dosing schedule, gender, center grouping, smoking status, and baseline mean morning PEF as covariates|||31.79|19.22|<0.001
72456916|NCT03137784|144436759|OTHER|Treatment difference|Linear Mixed Model (LMM)|24.29|||<|0.001|TWO_SIDED|95.0|17.99|30.59|||Linear Mixed Model|||||30.59|17.99|<0.001
72456917|NCT03137784|144436760|OTHER|Treatment difference|Linear Mixed Model (LMM)|30.95|||<|0.001|TWO_SIDED|95.0|25.07|36.82|||Linear Mixed Model||LS Mean of change from baseline in mean morning PEF is calculated with the ANCOVA model using treatment, stratification group, dosing schedule, gender, center grouping, smoking status, and baseline mean morning PEF as covariates|||36.82|25.07|<0.001
72456918|NCT03137784|144436760|OTHER|Treatment difference|Linear Mixed Model (LMM)|29.37|||<|0.001|TWO_SIDED|95.0|23.47|35.26|||Linear Mixed Model||LS Mean of change from baseline in mean morning PEF is calculated with the ANCOVA model using treatment, stratification group, dosing schedule, gender, center grouping, smoking status, and baseline mean morning PEF as covariates|||35.26|23.47|<0.001
72456919|NCT03137784|144436761|OTHER|Treatment difference|Linear Mixed Model (LMM)|-0.15||||0.053|TWO_SIDED|95.0|-0.31|0.0|||Linear Mixed Model|||||0.00|-0.31|0.053
72456920|NCT03137784|144436761|OTHER|Treatment difference|Linear Mixed Model (LMM)|-0.11||||0.163|TWO_SIDED|95.0|-0.27|0.05|||Linear Mixed Model|||||0.05|-0.27|0.163
72456921|NCT00508183|144436789|OTHER|||||||0.6|||||||t-test, 2 sided|||||||0.60
72500245|NCT00824564|144530919|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.8|STANDARD_ERROR_OF_MEAN|4.2||0.119|TWO_SIDED|95.0|-15.4|1.8|||t-test, 2 sided|||For 8 hour post-surgery, the mean difference with associated SE, and corresponding 95% CI for the comparisons of tranexamic acid plus standard of care against Standard of care was presented along with the p-value for the test. Two-sample t-test was performed at 5% level of significance.||1.8|-15.4|0.119
72456922|NCT00508183|144436790|OTHER|||||||0.05|||||||t-test, 2 sided|||||||0.05
72456923|NCT00508183|144436791|OTHER|||||||0.05|||||||t-test, 2 sided|||||||0.05
72456924|NCT00508183|144436793|OTHER|||||||0.05|||||||Chi-squared|||||||0.05
72456925|NCT01762982|144436832|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.0654||95.0|||||Signed Rank Test|||Null hypothesis considered no treatment difference between the treatments being compared.||||0.0654
72456926|NCT01762982|144436835|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.0078||95.0|||||Signed Rank Test|||Null hypothesis considered no treatment difference between the treatments being compared.||||0.0078
72456927|NCT01762982|144436836|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.0547||95.0|||||Signed Rank Test|||Null hypothesis considered no treatment difference between the treatments being compared.||||0.0547
72456928|NCT01029704|144436849|SUPERIORITY||Difference of LS Means|-16.923||||0.0989|TWO_SIDED|95.0|-37.076|3.23||P-values are from two-sided test at 5% level|ANCOVA|Analysis is based on ANCOVA with change from baseline as dependent variable and treatment as fixed effect and baseline and center as covariate.||||3.230|-37.076|0.0989
72456929|NCT01029704|144436849|SUPERIORITY||Difference of LS Means|-17.834||||0.0964|TWO_SIDED|95.0|-38.909|3.242||P-values are from two-sided test at 5% level|ANCOVA|Analysis is based on ANCOVA with change from baseline as dependent variable and treatment as fixed effect and baseline and center as covariate.||||3.242|-38.909|0.0964
72620793|NCT03707821|144772545|NON_INFERIORITY|A non-inferiority margin of -5 points was used. This margin is based on a 10% shift in the distribution of CLUE scores. Non-inferiority was declared in the lower limit of the 95% credible interval was above 5.|Mean Difference (Net)|8.03|STANDARD_DEVIATION|2.295|||TWO_SIDED|95.0|3.48|12.54|||Bayesian normal random-effects|A 95% Credible Interval for the Posterior mean difference between the Test and Control was used to test for non-inferiority.|Mean difference was calculated as Test minus Control.|Sample Size was based on primary endpoints only.||12.54|3.48|
72456930|NCT01029704|144436849|SUPERIORITY||Difference of LS Means|-19.991||||0.0465|TWO_SIDED|95.0|-39.67|-0.312||P-values are from two-sided test at 5% level|ANCOVA|Analysis is based on ANCOVA with change from baseline as dependent variable and treatment as fixed effect and baseline and center as covariate.||||-0.312|-39.670|0.0465
72456931|NCT01029704|144436849|SUPERIORITY||Difference of LS Means|-32.01||||0.0015|TWO_SIDED|95.0|-51.487|-12.533||P-values are from two-sided test at 5% level|ANCOVA|Analysis is based on ANCOVA with change from baseline as dependent variable and treatment as fixed effect and baseline and center as covariate.||||-12.533|-51.487|0.0015
72456932|NCT01029704|144436851|SUPERIORITY||Difference of LS Means|-1.434||||0.0025|TWO_SIDED|95.0|-2.349|-0.52||P-values are from a two-sided test.|ANCOVA|Analysis is based on ANCOVA with change from baseline as dependent variable and treatment as fixed effect and baseline and center as covariate.||||-0.520|-2.349|0.0025
72500246|NCT00824564|144530919|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-22.7|STANDARD_ERROR_OF_MEAN|15.16||0.139|TWO_SIDED|95.0|-52.9|7.5|||t-test, 2 sided|||For 24 hour post-surgery, the mean difference with associated SE, and corresponding 95% CI for the comparisons of tranexamic acid plus standard of care against Standard of care was presented along with the p-value for the test. Two-sample t-test was performed at 5% level of significance.||7.5|-52.9|0.139
72500247|NCT00824564|144530920|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|25.2|STANDARD_ERROR_OF_MEAN|132.1||0.849|TWO_SIDED|95.0|-238.2|288.6|||t-test, 2 sided|||The mean difference with associated SE, and corresponding 95% CI for the comparisons of tranexamic acid plus standard of care against Standard of care was presented along with the p-value for the test. Two-sample t-test was performed at 5% level of significance.||288.6|-238.2|0.849
72500248|NCT00824564|144530921|SUPERIORITY_OR_OTHER|||||||0.714|TWO_SIDED||||||Chi-squared|||Chi-square test was used at 5% level of significance.||||0.714
72620794|NCT00889005|144772546|SUPERIORITY_OR_OTHER|||||||0.927|||||||ANOVA|||||||0.927
72456933|NCT01029704|144436851|SUPERIORITY||Difference of LS Means|-1.037||||0.0269|TWO_SIDED|95.0|-1.952|-0.122||P-values are from a two-sided test|ANCOVA|Analysis is based on ANCOVA with change from baseline as dependent variable and treatment as fixed effect and baseline and center as covariate.||||-0.122|-1.952|0.0269
72456934|NCT01029704|144436851|SUPERIORITY||Difference of LS Means|-2.054|||<|0.0001|TWO_SIDED|95.0|-2.938|-1.17||P-values are from a two-sided test|ANCOVA|Analysis is based on ANCOVA with change from baseline as dependent variable and treatment as fixed effect and baseline and center as covariate.||||-1.170|-2.938|< 0.0001
72456935|NCT01029704|144436851|SUPERIORITY||Difference of LS Means|-1.172||||0.009|TWO_SIDED|95.0|-2.044|-0.301||P-values are from a two-sided test|ANCOVA|Analysis is based on ANCOVA with change from baseline as dependent variable and treatment as fixed effect and baseline and center as covariate.||||-0.301|-2.044|0.0090
72456936|NCT01029704|144436852|SUPERIORITY||Difference of LS Means|-0.353||||0.0281|TWO_SIDED|95.0|-0.668|-0.039||P-values are from a two-sided test|ANCOVA|Analysis is based on ANCOVA with change from baseline as dependent variable and treatment as fixed effect and baseline and center as covariate.||||-0.039|-0.668|0.0281
72456937|NCT01029704|144436852|SUPERIORITY||Difference of LS Means|-0.155||||0.3215|TWO_SIDED|95.0|-0.464|0.154||P-values are from a two-sided test|ANCOVA|Analysis is based on ANCOVA with change from baseline as dependent variable and treatment as fixed effect and baseline and center as covariate.||||0.154|-0.464|0.3215
72456938|NCT01029704|144436852|SUPERIORITY||Difference of LS Means|-0.004||||0.9776|TWO_SIDED|95.0|-0.304|0.295||P-values are from a two-sided test|ANCOVA|Analysis is based on ANCOVA with change from baseline as dependent variable and treatment as fixed effect and baseline and center as covariate.||||0.295|-0.304|0.9776
72456939|NCT01029704|144436852|SUPERIORITY||Difference of LS Means|-0.344||||0.0242|TWO_SIDED|95.0|-0.642|-0.046||P-values are from a two-sided test|ANCOVA|Analysis is based on ANCOVA with change from baseline as dependent variable and treatment as fixed effect and baseline and center as covariate.||||-0.046|-0.642|0.0242
72456940|NCT01029704|144436854|SUPERIORITY||Difference of LS Means|17.688||||0.1613|TWO_SIDED|95.0|-7.21|42.587||P-values are from a two-sided test|ANCOVA|Analysis is based on ANCOVA with change from baseline as dependent variable and treatment as fixed effect and baseline and center as covariate.||||42.587|-7.210|0.1613
72456941|NCT01029704|144436854|SUPERIORITY||Difference of LS Means|17.091||||0.2079|TWO_SIDED|95.0|-9.696|43.877||P-values are from a two-sided test|ANCOVA|Analysis is based on ANCOVA with change from baseline as dependent variable and treatment as fixed effect and baseline and center as covariate.||||43.877|-9.696|0.2079
72456942|NCT01029704|144436854|SUPERIORITY||Difference of LS Means|24.379||||0.041|TWO_SIDED|95.0|1.028|47.731||P-values are from a two-sided test|ANCOVA|Analysis is based on ANCOVA with change from baseline as dependent variable and treatment as fixed effect and baseline and center as covariate.||||47.731|1.028|0.0410
72456943|NCT01029704|144436854|SUPERIORITY||Difference of LS Means|20.749||||0.0862|TWO_SIDED|95.0|-3.019|44.518||P-values are from a two-sided test|ANCOVA|Analysis is based on ANCOVA with change from baseline as dependent variable and treatment as fixed effect and baseline and center as covariate.||||44.518|-3.019|0.0862
72456944|NCT00089791|144436856|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.32|||<|0.0001||95.0|0.26|0.41||Logistic regression was used to generate the p-value|Mantel Haenszel|||||0.41|0.26|<0.0001
72456945|NCT00089791|144436857|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.8||||0.0106||95.0|0.67|0.95|||Regression, Cox|||||0.95|0.67|0.0106
72456946|NCT00089791|144436858|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.6||||0.0362||95.0|0.37|0.97|||Regression, Cox|||||0.97|0.37|0.0362
72456947|NCT01235936|144436865|OTHER|The primary endpoint was compared using the Wilcoxon signed-rank test, with an alpha level of 0.05.||||||0.002|||||||Wilcoxon signed rank test|||Analysis of change from baseline on Day 29||||0.0020
72456948|NCT01235936|144436866|OTHER|The test was based on Wilcoxon signed rank test, with an alpha level of 0.05.|||||=|0.0156|||||||Wilcoxon signed rank test|||Analysis of change from baseline on Day 29||||=0.0156
72456949|NCT01235936|144436867|OTHER|The test was based on Wilcoxon signed rank test, with an alpha level of 0.05.||||||0.0098|||||||Wilcoxon signed rank test|||Analysis of change from baseline on Day 29||||0.0098
72456950|NCT01235936|144436868|OTHER|The test was based on Wilcoxon signed rank test, with an alpha level of 0.05.|||||=|0.0195|||||||Wilcoxon signed rank test|||Analysis of change from baseline on Day 29||||=0.0195
72456951|NCT01235936|144436869|OTHER|The test was based on Wilcoxon signed rank test, with an alpha level of 0.05.|||||=|0.8262|||||||Wilcoxon signed rank test|||Analysis of change from baseline on Day 29||||=0.8262
72456952|NCT01235936|144436875|OTHER|The test was based on Wilcoxon signed rank test, with an alpha level of 0.05.|||||=|0.002|||||||Wilcoxon signed rank test|||Analysis of change from baseline on Day 29||||=0.0020
72456953|NCT01235936|144436876|OTHER|The test was based on Wilcoxon signed rank test, with an alpha level of 0.05.|||||=|0.2383|||||||Wilcoxon signed rank test|||Analysis of change from baseline on Day 29||||=0.2383
72456954|NCT01235936|144436877|OTHER|The test was based on Wilcoxon signed rank test, with an alpha level of 0.05.|||||=|0.0039|||||||Wilcoxon signed rank test|||Analysis of change from baseline on Day 29||||=0.0039
72456955|NCT01235936|144436878|OTHER|The test was based on Wilcoxon signed rank test, with an alpha level of 0.05.|||||=|0.0039|||||||Wilcoxon signed rank test|||Analysis of change from baseline on Day 29||||=0.0039
72456956|NCT03212638|144436936|EQUIVALENCE|0.80, 1.25 as the bioequivalence boundaries|Ratio|1.04|||||TWO_SIDED|95.0|0.946|1.15||||||Bioequivalence of single 4 mg dose of baricitinib as the suspension formulation with (T1) water compared to the commercial tablet (R).||1.15|0.946|
72456957|NCT03212638|144436936|EQUIVALENCE|0.80, 1.25 as the bioequivalence boundaries|ratio|1.04|||||TWO_SIDED|95.0|0.944|1.14||||||Bioequivalence of single 4 mg dose of baricitinib as the suspension formulation without (T2) water compared to the commercial tablet (R).||1.14|0.944|
72456958|NCT03212638|144436936|EQUIVALENCE|0.80, 1.25 as the bioequivalence boundaries|Ratio|0.675|||||TWO_SIDED|95.0|0.617|0.74||||||Bioequivalence of single 4 mg dose of baricitinib as fasted vs fed.||0.740|0.617|
72456959|NCT03212638|144436937|EQUIVALENCE|0.80, 1.25 as the bioequivalence boundaries|Ratio|0.996|||||TWO_SIDED|95.0|0.963|1.03||||||Bioequivalence of single 4 mg dose of baricitinib as the suspension formulation with (T1) water compared to the commercial tablet (R).||1.03|0.963|
72456960|NCT03212638|144436937|EQUIVALENCE|0.80, 1.25 as the bioequivalence boundaries|Ratio|0.998|||||TWO_SIDED|95.0|0.995|1.03||||||Bioequivalence of s single 4 mg dose of baricitinib as the suspension formulation without (T2) water compared to the commercial tablet (R).||1.03|0.995|
72456961|NCT03212638|144436937|EQUIVALENCE|0.80, 1.25 as the bioequivalence boundaries|ratio|0.973|||||TWO_SIDED|95.0|0.936|1.01||||||Bioequivalence of single 4 mg dose of baricitinib as fasted vs fed.||1.01|0.936|
72456962|NCT03212638|144436938|EQUIVALENCE|0.80, 1.25 as the bioequivalence boundaries|Ratio|0.999|||||TWO_SIDED|95.0|0.996|1.03||||||Bioequivalence of single 4 mg dose of baricitinib as the suspension formulation with (T1) water compared to the commercial tablet (R).||1.03|0.996|
72456963|NCT03212638|144436938|EQUIVALENCE|0.80, 1.25 as the bioequivalence boundaries|Ratio|0.999|||||TWO_SIDED|95.0|0.966|1.03||||||Bioequivalence of single 4 mg dose of baricitinib as the suspension formulation with (T1) water compared to the commercial tablet (R).||1.03|0.966|
72456964|NCT03212638|144436938|EQUIVALENCE|0.80, 1.25 as the bioequivalence boundaries|ratio|0.978|||||TWO_SIDED|95.0|0.941|1.02||||||Bioequivalence of single 4 mg dose of baricitinib as fasted vs fed.||1.02|0.941|
72456965|NCT03652610|144436939|NON_INFERIORITY|Non-inferiority is concluded if the lower limit of the two sided 95% CI for the hSBA GMT ratio for serogroup A is \> 0.5|GMT ratio|0.88|||||TWO_SIDED|95.0|0.64|1.2|||ANCOVA|Analysis of Covariance (ANCOVA) including pre-vaccination titer (Day 1) as a covariate and with vaccine group and country as factors.||To demonstrate non-inferiority of the investigational MenACWY liquid vaccine with approximately 30% Men A FS (GSK3536820A ACWY\_Liq Group) to that of currently licensed MenACWY vaccine (ACWY Group), as measured by the adjusted human serum bactericidal assay (hSBA) Geometric Mean Titers (GMTs) directed against N. meningitidis serogroup A at Day 29 after a single dose vaccination||1.20|0.64|
72456966|NCT03652610|144436940|OTHER||GMT ratio|1.19|||||TWO_SIDED|95.0|0.84|1.68|||ANCOVA|Analysis of Covariance (ANCOVA) including pre-vaccination titer (Day 1) as a covariate and with vaccine group and country as factors.||To compare the immunogenicity of the investigational MenACWY liquid vaccine with approximately 30% Men A FS (GSK3536820A ACWY\_Liq Group) and the currently licensed MenACWY vaccine (ACWY Group), as measured by the adjusted hSBA GMTs directed against N. meningitidis serogroup C at Day 29||1.68|0.84|
72500249|NCT00824564|144530922|SUPERIORITY_OR_OTHER||Least square means difference|0.37|STANDARD_ERROR_OF_MEAN|0.295||0.208|TWO_SIDED|95.0|-0.21|0.96|||Mixed Models Analysis|||For change at end of surgery, a Mixed Model Repeated Measures (MMRM) approach was used to relate the dependent (outcome) variable and independent (treatment, time point, and treatment-by-time point interaction as factors and baseline value as co-variate) variables taking into account the within-participant correlation arising from the repeated measurements.||0.96|-0.21|0.208
72500250|NCT00824564|144530922|SUPERIORITY_OR_OTHER||Least square means difference|0.1|STANDARD_ERROR_OF_MEAN|0.255||0.682|TWO_SIDED|95.0|-0.4|0.61|||Mixed Models Analysis|||For change at 1 hour post-surgery, a MMRM approach was used to relate the dependent (outcome) variable and independent (treatment, time point, and treatment-by-time point interaction as factors and baseline value as co-variate) variables taking into account the within-participant correlation arising from the repeated measurements.||0.61|-0.40|0.682
72456967|NCT03652610|144436940|OTHER||GMT ratio|1.23|||||TWO_SIDED|95.0|0.96|1.58|||ANCOVA|Analysis of Covariance (ANCOVA) including pre-vaccination titer (Day 1) as a covariate and with vaccine group and country as factors.||To compare the immunogenicity of the investigational MenACWY liquid vaccine with approximately 30% Men A FS (GSK3536820A ACWY\_Liq Group) and the currently licensed MenACWY vaccine (ACWY Group), as measured by the adjusted hSBA GMTs directed against N. meningitidis serogroup W at Day 29||1.58|0.96|
72456968|NCT03652610|144436940|OTHER||GMT ratio|1.19|||||TWO_SIDED|95.0|0.9|1.58|||ANCOVA|Analysis of Covariance (ANCOVA) including pre-vaccination titer (Day 1) as a covariate and with vaccine group and country as factors.||To compare the immunogenicity of the investigational MenACWY liquid vaccine with approximately 30% Men A FS (GSK3536820A ACWY\_Liq Group) and the currently licensed MenACWY vaccine (ACWY Group), as measured by the adjusted hSBA GMTs directed against N. meningitidis serogroup Y at Day 29||1.58|0.90|
72456969|NCT03652610|144436942|OTHER||Difference in percentage of subjects|-3.87|||||TWO_SIDED|95.0|-9.3|1.52|||Miettinen and Nurminen score method|||Between-group difference in percentage of subjects with a ≥ 4-fold rise in post-vaccination hSBA for N. meningitidis serogroup A at Day 29.||1.52|-9.30|
72456970|NCT03652610|144436942|OTHER||Difference in percentage of subjects|1.87|||||TWO_SIDED|95.0|-4.7|8.43|||Miettinen and Nurminen score method|||Between-group difference in percentage of subjects with a ≥ 4-fold rise in post-vaccination hSBA for N. meningitidis serogroup C at Day 29.||8.43|-4.70|
72456971|NCT03652610|144436942|OTHER||Difference in percentage of subjects|4.54|||||TWO_SIDED|95.0|-1.97|11.01|||Miettinen and Nurminen score method|||Between-group difference in percentage of subjects with a ≥ 4-fold rise in post-vaccination hSBA for N. meningitidis serogroup W at Day 29.||11.01|-1.97|
72456972|NCT03652610|144436942|OTHER||Difference in percentage of subjects|5.25|||||TWO_SIDED|95.0|-1.11|11.57|||Miettinen and Nurminen score method|||Between-group difference in percentage of subjects with a ≥ 4-fold rise in post-vaccination hSBA for N. meningitidis serogroup Y at Day 29.||11.57|-1.11|
72456973|NCT03652610|144436943|OTHER||Difference in percentage of subjects|-2.47|||||TWO_SIDED|95.0|-6.47|1.49|||Miettinen and Nurminen score method|||Between-group difference in percentages of subjects with hSBA titer ≥8 for the N. meningitidis serogroup A at Day 1||1.49|-6.47|
72456974|NCT03652610|144436943|OTHER||Difference in percentage of subjects|-0.58|||||TWO_SIDED|95.0|-6.99|5.83|||Miettinen and Nurminen score method|||Between-group difference in percentages of subjects with hSBA titer ≥8 for the N. meningitidis serogroup C at Day 1||5.83|-6.99|
72456975|NCT03652610|144436943|OTHER||Difference in percentage of subjects|-5.95|||||TWO_SIDED|95.0|-12.33|0.47|||Miettinen and Nurminen score method|||Between-group difference in percentages of subjects with hSBA titer ≥8 for the N. meningitidis serogroup W at Day 1||0.47|-12.33|
72456976|NCT03652610|144436943|OTHER||Difference in percentage of subjects|-2.78|||||TWO_SIDED|95.0|-8.3|2.76|||Miettinen and Nurminen score method|||Between-group difference in percentages of subjects with hSBA titer ≥8 for the N. meningitidis serogroup Y at Day 1||2.76|-8.30|
72456977|NCT03652610|144436943|OTHER||Difference in percentage of subjects|-3.69|||||TWO_SIDED|95.0|-8.65|1.21|||Miettinen and Nurminen score method|||Between-group difference in percentages of subjects with hSBA titer ≥8 for the N. meningitidis serogroup A at Day 29||1.21|-8.65|
72456978|NCT03652610|144436943|OTHER||Difference in percentage of subjects|-0.4|||||TWO_SIDED|95.0|-6.12|5.33|||Miettinen and Nurminen score method|||Between-group difference in percentages of subjects with hSBA titer ≥8 for the N. meningitidis serogroup C at Day 29||5.33|-6.12|
72456979|NCT03652610|144436943|OTHER||Difference in percentage of subjects|0.26|||||TWO_SIDED|95.0|-5.49|6.02|||Miettinen and Nurminen score method|||Between-group difference in percentages of subjects with hSBA titer ≥8 for the N. meningitidis serogroup W at Day 29||6.02|-5.49|
72456980|NCT03652610|144436943|OTHER||Difference in percentage of subjects|1.15|||||TWO_SIDED|95.0|-4.33|6.62|||Miettinen and Nurminen score method|||Between-group difference in percentages of subjects with hSBA titer ≥8 for the N. meningitidis serogroup Y at Day 29||6.62|-4.33|
72456981|NCT03652610|144436944|OTHER||Difference in percentage of subjects|-2.91|||||TWO_SIDED|95.0|-7.24|1.37|||Miettinen and Nurminen score method|||Between-group difference in percentages of subjects with hSBA titer ≥LLOQ for the N. meningitidis serogroup A at Day 1||1.37|-7.24|
72456982|NCT03652610|144436944|OTHER||Difference in percentage of subjects|-1.09|||||TWO_SIDED|95.0|-7.34|5.16|||Miettinen and Nurminen score method|||Between-group difference in percentages of subjects with hSBA titer ≥LLOQ for the N. meningitidis serogroup C at Day 1||5.16|-7.34|
72456983|NCT03652610|144436944|OTHER||Difference in percentage of subjects|-5.95|||||TWO_SIDED|95.0|-12.35|0.5|||Miettinen and Nurminen score method|||Between-group difference in percentages of subjects with hSBA titer ≥LLOQ for the N. meningitidis serogroup W at Day 1||0.50|-12.35|
72456984|NCT03652610|144436944|OTHER||Difference in percentage of subjects|-2.55|||||TWO_SIDED|95.0|-8.15|3.06|||Miettinen and Nurminen score method|||Between-group difference in percentages of subjects with hSBA titer ≥LLOQ for the N. meningitidis serogroup Y at Day 1||3.06|-8.15|
72456985|NCT03652610|144436944|OTHER||Difference in percentage of subjects|-3.92|||||TWO_SIDED|95.0|-8.87|0.96|||Miettinen and Nurminen score method|||Between-group difference in percentages of subjects with hSBA titer ≥LLOQ for the N. meningitidis serogroup A at Day 29||0.96|-8.87|
72456986|NCT03652610|144436944|OTHER||Difference in percentage of subjects|0.07|||||TWO_SIDED|95.0|-5.52|5.65|||Miettinen and Nurminen score method|||Between-group difference in percentages of subjects with hSBA titer ≥LLOQ for the N. meningitidis serogroup C at Day 29||5.65|-5.52|
72620795|NCT05122143|144772590|SUPERIORITY|||||||0.0085||||||Treatment D (A+B) versus Treatment C|ANCOVA|||"Treatment A + B were pooled to Treatment D for the Primary endpoint. The primary objective was to compare the efficacy of the AM-301 nasal spray (treatment D= A+B) and no treatment (C) in reducing nasal symptoms induced from HDM allergen exposure.~The TNSS value from the baseline exposure (at screening exposure visit 2) was subtracted from the TNSS value of the treatment exposure to obtain change from baseline. A lower value resembles less symptoms."||||0.0085
72456987|NCT03652610|144436944|OTHER||Difference in percentage of subjects|-0.17|||||TWO_SIDED|95.0|-5.92|5.57|||Miettinen and Nurminen score method|||Between-group difference in percentages of subjects with hSBA titer ≥LLOQ for the N. meningitidis serogroup W at Day 29||5.57|-5.92|
72456988|NCT03652610|144436944|OTHER||Difference in percentage of subjects|0.5|||||TWO_SIDED|95.0|-4.89|5.9|||Miettinen and Nurminen score method|||Between-group difference in percentages of subjects with hSBA titer ≥LLOQ for the N. meningitidis serogroup Y at Day 29||5.90|-4.89|
72456989|NCT01860079|144436950|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Chi-squared, Corrected|||Categorical data were analyzed with χ2.Comparisons were also analyzed by χ2 between the early discharge and standard treatment arm for the primary outcomes.||||<0.05
72456990|NCT02970318|144436963|OTHER||Hazard Ratio (HR)|0.31|||<|0.0001|TWO_SIDED|95.0|0.2|0.49||Stratified by randomization stratification factors as recorded in IXRS, i.e., presence of del17p (Yes/No), ECOG (0-1/2), # of prior therapies (1-3/4+).|Log Rank||Cox Proportional Hazard Model (Arm A vs. Arm B) stratified by factors as recorded in IXRS, i.e., presence of del17p (Yes/No), ECOG (0-1/2), # of prior therapies (1-3/4+).|||0.49|0.20|<0.0001
72456991|NCT02970318|144436964|OTHER||Hazard Ratio (HR)|0.28|||<|0.0001|TWO_SIDED|95.0|0.2|0.38||Stratified by randomization stratification factors as recorded in IXRS, i.e., presence of del17p (Yes/No), ECOG (0-1/2), # of prior therapies (1-3/4+).|Log Rank||Cox Proportional Hazard Model (Arm A vs. Arm B) stratified by factors as recorded in IXRS, i.e., presence of del17p (Yes/No), ECOG (0-1/2), # of prior therapies (1-3/4+).|||0.38|0.20|<0.0001
72456992|NCT02970318|144436965|OTHER||Risk Difference (RD)|5.8||||0.2248|TWO_SIDED|95.0|-3.3|14.9|||Cochran-Mantel-Haenszel|Based on Cochran-Mantel-Haenszel test with adjustment for randomization stratification factors as recorded in IXRS.|Risk difference (% Arm A - Arm B) based on Cochran-Mantel-Haenszel test with adjustment for randomization stratification factors as recorded in IXRS.|||14.9|-3.3|0.2248
72456993|NCT02970318|144436966|OTHER||Risk Difference (RD)|-1.3||||0.734|TWO_SIDED|95.0|-9.6|7.0|||Cochran-Mantel-Haenszel|Based on Cochran-Mantel-Haenszel test with adjustment for randomization stratification factors as recorded in IXRS.|Risk difference (% Arm A - Arm B) based on Cochran-Mantel-Haenszel test with adjustment for randomization stratification factors as recorded in IXRS.|||7.0|-9.6|0.7340
72456994|NCT02970318|144436967|OTHER||Hazard Ratio (HR)|0.69||||0.0783|TWO_SIDED|95.0|0.46|1.04|||Log Rank|Log-Rank Analysis stratified by factors recorded in IXRS data: presence of deletion 17 p (yes / no), ECOG (0-1/2), # of prior therapies (1-3/4+).|Cox proportional hazard analysis stratified (Arm A vs. Arm B) by factors recorded in IXRS data including presence of deletion 17 p (yes / no), ECOG (0-1/2), # of prior therapies (1-3/4+).|Analysis stratified by factors recorded in IXRS data including presence of deletion 17 p (yes / no), ECOG (0-1/2), # of prior therapies (1-3/4+).||1.04|0.46|0.0783
72456995|NCT02970318|144436968|OTHER||Hazard Ratio (HR)|0.33|||<|0.0001|TWO_SIDED|95.0|0.19|0.59||Log Rank Test stratified by factors as recorded in IXRS, i.e., presence of del17p (Yes/No), ECOG (0-1/2), # of prior therapies (1-3/4+).|Log Rank||Cox Proportional Hazard Model (Arm A vs. Arm B) stratified by factors as recorded in IXRS, i.e., presence of del17p (Yes/No), ECOG (0-1/2), # of prior therapies (1-3/4+).|||0.59|0.19|<0.0001
72370443|NCT00488683|144251631|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|0.08||||0.46||95.0||||Values from Group 1, 2 and 3 were combined for this analysis.|Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccinations and serogroup specific IgG concentration at 12 months of age for the serogroup C||||0.46
72456996|NCT02970318|144436969|OTHER||Hazard Ratio (HR)|0.23|||<|0.0001|TWO_SIDED|95.0|0.16|0.33||Log Rank Test stratified by factors as recorded in IXRS, i.e., presence of del17p (Yes/No), ECOG (0-1/2), # of prior therapies (1-3/4+).|Log Rank||Cox Proportional Hazard Model (Arm A vs. Arm B) stratified by factors as recorded in IXRS, i.e., presence of del17p (Yes/No), ECOG (0-1/2), # of prior therapies (1-3/4+).|||0.33|0.16|<0.0001
72456997|NCT02970318|144436970|OTHER||Hazard Ratio (HR)|0.29|||<|0.0001|TWO_SIDED|95.0|0.21|0.4||Log Rank Test stratified by factors as recorded in IXRS, i.e., presence of del17p (Yes/No), ECOG (0-1/2), # of prior therapies (1-3/4+).|Log Rank||Cox Proportional Hazard Model (Arm A vs. Arm B) stratified by factors as recorded in IXRS, i.e., presence of del17p (Yes/No), ECOG (0-1/2), # of prior therapies (1-3/4+).|||0.40|0.21|<0.0001
72500251|NCT00824564|144530922|SUPERIORITY_OR_OTHER||Least square means difference|0.14|STANDARD_ERROR_OF_MEAN|0.244||0.569|TWO_SIDED|95.0|-0.35|0.63|||Mixed Models Analysis|||For change at day 1 post-surgery, a MMRM approach was used to relate the dependent (outcome) variable and independent (treatment, time point, and treatment-by-time point interaction as factors and baseline value as co-variate) variables taking into account the within-participant correlation arising from the repeated measurements.||0.63|-0.35|0.569
72456998|NCT01323790|144436985|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.188||||0.202|TWO_SIDED|95.0|0.911|1.548|||Cochran-Mantel-Haenszel|||Analysis via Cochran Mantel-Haenszel test stratified by response to laxatives at baseline (LIR, LAR, LUR).||1.548|0.911|0.202
72456999|NCT01323790|144436985|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.348||||0.021|TWO_SIDED|95.0|1.045|1.739|||Cochran-Mantel-Haenszel|||Analysis via Cochran Mantel-Haenszel test stratified by response to laxatives at baseline (LIR, LAR, LUR).||1.739|1.045|0.021
72457000|NCT01323790|144436986|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.35||||0.074|TWO_SIDED|95.0|0.967|1.884||Response rate over Weeks 1 to 12 in the LIR subgroup is a key secondary endpoint included in the multiple testing procedure.|Cochran-Mantel-Haenszel|||||1.884|0.967|0.074
72457001|NCT01323790|144436986|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.489||||0.014|TWO_SIDED|95.0|1.078|2.058||Response rate over Weeks 1 to 12 in the LIR subgroup is a key secondary endpoint included in the multiple testing procedure.|Cochran-Mantel-Haenszel|||||2.058|1.078|0.014
72457002|NCT01323790|144436988|SUPERIORITY_OR_OTHER||LS mean difference|0.39||||0.01|TWO_SIDED|95.0|0.09|0.69|||Mixed Models Analysis|||Analysis via Mixed Model Repeated Measures (MMRM) with fixed effects for baseline, baseline laxative response, treatment and treatment time interaction. Study pooled center is included as a random effect.||0.69|0.09|0.010
72620796|NCT02965976|144772657|SUPERIORITY|||||||0.773|||||||Cochran-Mantel-Haenszel|||||||0.773
72620797|NCT02965976|144772658|SUPERIORITY|||||||0.773|||||||Cochran-Mantel-Haenszel|||||||0.773
72620798|NCT02965976|144772659|SUPERIORITY|||||||0.368|||||||t-test, 2 sided|||||||0.368
72620799|NCT02965976|144772660|SUPERIORITY|||||||0.987|||||||t-test, 2 sided|||||||0.987
72457003|NCT01323790|144436988|SUPERIORITY_OR_OTHER||Ls mean difference|0.68|||<|0.001|TWO_SIDED|95.0|0.37|0.98|||Mixed Models Analysis|||Analysis via MMRM with fixed effects for baseline, baseline laxative response, treatment and treatment time interaction. Study pooled center is included as a random effect.||0.98|0.37|<0.001
72457004|NCT01323790|144436989|SUPERIORITY_OR_OTHER||LS mean difference|-0.19||||0.005|TWO_SIDED|95.0|-0.32|-0.06|||Mixed Models Analysis|||Analysis via MMRM with fixed effects for baseline, baseline laxative response (LIR, non-LIR), treatment and treatment time interaction. Study pooled center is included as a random effect.||-0.06|-0.32|0.005
72457005|NCT01323790|144436989|SUPERIORITY_OR_OTHER||LS mean difference|-0.32|||<|0.001|TWO_SIDED|95.0|-0.45|-0.18|||Mixed Models Analysis|||Analysis via MMRM with fixed effects for baseline, baseline laxative response (LIR, non-LIR), treatment and treatment time interaction. Study pooled center is included as a random effect.||-0.18|-0.45|<0.001
72457006|NCT01323790|144436990|SUPERIORITY_OR_OTHER||LS mean difference|0.28||||0.001|TWO_SIDED|95.0|0.12|0.45|||Mixed Models Analysis|||Analysis via MMRM with fixed effects for baseline, baseline laxative response (LIR, non-LIR), treatment and treatment time interaction. Study pooled center is included as a random effect.||0.45|0.12|0.001
72457007|NCT01323790|144436990|SUPERIORITY_OR_OTHER||LS mean difference|0.45|||<|0.001|TWO_SIDED|95.0|0.29|0.62|||Mixed Models Analysis|||Analysis via MMRM with fixed effects for baseline, baseline laxative response (LIR, non-LIR), treatment and treatment time interaction. Study pooled center is included as a random effect.||0.62|0.29|<0.001
72457008|NCT01323790|144436991|SUPERIORITY_OR_OTHER||LS mean difference|6.72||||0.002|TWO_SIDED|95.0|2.37|11.06|||Mixed Models Analysis|||Analysis via MMRM with fixed effects for baseline, baseline laxative response (LIR, non-LIR), treatment and treatment time interaction. Study pooled center is included as a random effect.||11.06|2.37|0.002
72457009|NCT01323790|144436991|SUPERIORITY_OR_OTHER||LS mean difference|10.43|||<|0.001|TWO_SIDED|95.0|6.03|14.84|||Mixed Models Analysis|||Analysis via MMRM with fixed effects for baseline, baseline laxative response (LIR, non-LIR), treatment and treatment time interaction. Study pooled center is included as a random effect.||14.84|6.03|<0.001
72457010|NCT01323790|144436992|SUPERIORITY_OR_OTHER||LS mean difference|0.52||||0.028|TWO_SIDED|95.0|0.06|0.98|||Mixed Models Analysis|||Analysis via MMRM with fixed effects for baseline, baseline laxative response (LIR, non-LIR), treatment and treatment time interaction. Study pooled center is included as a random effect.||0.98|0.06|0.028
72457011|NCT01323790|144436992|SUPERIORITY_OR_OTHER||LS mean difference|1.04|||<|0.001|TWO_SIDED|95.0|0.58|1.51|||Mixed Models Analysis|||Analysis via MMRM with fixed effects for baseline, baseline laxative response (LIR, non-LIR), treatment and treatment time interaction. Study pooled center is included as a random effect.||1.51|0.58|<0.001
72457012|NCT01323790|144436994|SUPERIORITY_OR_OTHER||LS mean difference|-0.12||||0.08|TWO_SIDED|95.0|-0.26|0.01||Analysis for change in PAC-SYM total score from baseline (Week 1) to end of treatment (Week 12)|Mixed Models Analysis|||Analysis via MMRM with fixed effects for baseline, baseline laxative response, treatment and treatment time interaction. Study pooled center is included as a random effect.||0.01|-0.26|0.080
72457013|NCT01323790|144436994|SUPERIORITY_OR_OTHER||LS mean difference|-0.18||||0.011|TWO_SIDED|95.0|-0.32|-0.04||Analysis for change in PAC-SYM total score from baseline (Week 1) to end of treatment (Week 12)|Mixed Models Analysis|||Analysis via MMRM with fixed effects for baseline, baseline laxative response, treatment and treatment time interaction. Study pooled center is included as a random effect.||-0.04|-0.32|0.011
72457014|NCT01323790|144436994|SUPERIORITY_OR_OTHER||Slope|0.05||||0.552|TWO_SIDED|95.0|-0.11|0.2||Analysis for change in PAC-SYM abdominal symptoms subscore from baseline (Week 1) to end of treatment (Week 12)|Mixed Models Analysis|||Analysis via MMRM with fixed effects for baseline, baseline laxative response, treatment and treatment time interaction. Study pooled center is included as a random effect.||0.20|-0.11|0.552
72457015|NCT01323790|144436994|SUPERIORITY_OR_OTHER||LS mean difference|0.09||||0.236|TWO_SIDED|95.0|-0.06|0.25||Analysis for change in PAC-SYM abdominal symptoms subscore from baseline (Week 1) to end of treatment (Week 12)|Mixed Models Analysis|||Analysis via MMRM with fixed effects for baseline, baseline laxative response, treatment and treatment time interaction. Study pooled center is included as a random effect.||0.25|-0.06|0.236
72500252|NCT00824564|144530922|SUPERIORITY_OR_OTHER||Least square means difference|0.2|STANDARD_ERROR_OF_MEAN|0.249||0.413|TWO_SIDED|95.0|-0.29|0.7|||Mixed Models Analysis|||For change at day 2 post-surgery, a MMRM approach was used to relate the dependent (outcome) variable and independent (treatment, time point, and treatment-by-time point interaction as factors and baseline value as co-variate) variables taking into account the within-participant correlation arising from the repeated measurements.||0.70|-0.29|0.413
72620800|NCT02965976|144772661|SUPERIORITY|||||||0.423|||||||Cochran-Mantel-Haenszel|||||||0.423
72620801|NCT02965976|144772662|SUPERIORITY|||||||1|||||||Cochran-Mantel-Haenszel|||||||1.000
72620802|NCT00318136|144772710|SUPERIORITY_OR_OTHER||Percentage of patients|3.2||||||90.0|0.3|13.5|||Blyth-Still-Casella|||||13.5|0.3|
72620803|NCT03769116|144772723|OTHER||Hodges-Lehmann treatment diff|6.11|||<|0.0001|TWO_SIDED|95.0|2.08|12.58|||Wilcoxon rank sum test|||Analysis conducted on changes from baseline.||12.58|2.08|< 0.0001
72620804|NCT03769116|144772724|OTHER||LSM Change Difference|0.8|STANDARD_ERROR_OF_MEAN|0.9|=|0.373|TWO_SIDED|95.0|-1.0|2.7|||Mixed-model for Repeated Measures|||||2.7|-1.0|= 0.3730
72620805|NCT03769116|144772732|OTHER||LSM Change Difference|2.5|STANDARD_ERROR_OF_MEAN|0.9|=|0.0172|TWO_SIDED|95.0|0.5|4.4|||Mixed-model for Repeated Measures|||Change from baseline - Age Group: 4-5 years old||4.4|0.5|= 0.0172
72620806|NCT03769116|144772732|OTHER||LSM Change Difference|-0.7|STANDARD_ERROR_OF_MEAN|1.1|=|0.5384|TWO_SIDED|95.0|-3.0|1.6|||Mixed-model for Repeated Measures|||Change from baseline - Age Group: 6-7 years old||1.6|-3.0|= 0.5384
72457016|NCT01323790|144436994|SUPERIORITY_OR_OTHER||LS mean difference|-0.11||||0.095|TWO_SIDED|95.0|-0.24|0.02||Analysis for change in PAC-SYM rectal symptoms subscore from baseline (Week 1) to end of treatment (Week 12)|Mixed Models Analysis|||Analysis via MMRM with fixed effects for baseline, baseline laxative response, treatment and treatment time interaction. Study pooled center is included as a random effect.||0.02|-0.24|0.095
72457017|NCT01323790|144436994|SUPERIORITY_OR_OTHER||LS mean difference|-0.24|||<|0.001|TWO_SIDED|95.0|-0.37|-0.1||Analysis for change in PAC-SYM rectal symptoms subscore from baseline (Week 1) to end of treatment (Week 12)|Mixed Models Analysis|||Analysis via MMRM with fixed effects for baseline, baseline laxative response, treatment and treatment time interaction. Study pooled center is included as a random effect.||-0.10|-0.37|<0.001
72457018|NCT01323790|144436994|SUPERIORITY_OR_OTHER||LS mean difference|-0.27||||0.002|TWO_SIDED|95.0|-0.44|-0.1||Analysis for change in PAC-SYM stool symptoms subscore from baseline (Week 1) to end of treatment (Week 12)|Mixed Models Analysis|||Analysis via MMRM with fixed effects for baseline, baseline laxative response, treatment and treatment time interaction. Study pooled center is included as a random effect.||-0.10|-0.44|0.002
72457019|NCT01323790|144436994|SUPERIORITY_OR_OTHER||LS mean difference|-0.38|||<|0.001|TWO_SIDED|95.0|-0.56|-0.21||Analysis for change in PAC-SYM stool symptoms subscore from baseline (Week 1) to end of treatment (Week 12)|Mixed Models Analysis|||Analysis via MMRM with fixed effects for baseline, baseline laxative response, treatment and treatment time interaction. Study pooled center is included as a random effect.||-0.21|-0.56|<0.001
72457020|NCT01323790|144436995|SUPERIORITY_OR_OTHER||LS mean difference|-0.31||||0.011|TWO_SIDED|95.0|-0.54|-0.07|||Mixed Models Analysis|||Analysis via MMRM with fixed effects for baseline, baseline laxative response, treatment and treatment time interaction. Study pooled center is included as a random effect.||-0.07|-0.54|0.011
72457021|NCT01323790|144436995|SUPERIORITY_OR_OTHER||LS mean difference|-0.49|||<|0.001|TWO_SIDED|95.0|-0.73|-0.25|||Mixed Models Analysis|||Analysis via MMRM with fixed effects for baseline, baseline laxative response, treatment and treatment time interaction. Study pooled center is included as a random effect.||-0.25|-0.73|<0.001
72457022|NCT01263496|144437006|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.401|||||TWO_SIDED|95.0|-0.618|-0.184||||||||-0.184|-0.618|
72457023|NCT01263496|144437006|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.548|||||TWO_SIDED|95.0|-0.739|-0.358||||||||-0.358|-0.739|
72457024|NCT01263496|144437006|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.59|||||TWO_SIDED|95.0|-0.779|-0.401||||||||-0.401|-0.779|
72457025|NCT01263496|144437006|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.708|||||TWO_SIDED|95.0|-0.894|-0.522||||||||-0.522|-0.894|
72457026|NCT01263496|144437007|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.316|||||TWO_SIDED|95.0|-0.538|-0.093||||||||-0.093|-0.538|
72457027|NCT01263496|144437007|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.493|||||TWO_SIDED|95.0|-0.684|-0.302||||||||-0.302|-0.684|
72457028|NCT01263496|144437007|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.51|||||TWO_SIDED|95.0|-0.706|-0.314||||||||-0.314|-0.706|
72457029|NCT01263496|144437007|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.647|||||TWO_SIDED|95.0|-0.834|-0.461||||||||-0.461|-0.834|
72457030|NCT01263496|144437008|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.263|||||TWO_SIDED|95.0|-0.479|-0.047||||||||-0.047|-0.479|
72457031|NCT01263496|144437008|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.395|||||TWO_SIDED|95.0|-0.598|-0.192||||||||-0.192|-0.598|
72457032|NCT01263496|144437008|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.405|||||TWO_SIDED|95.0|-0.616|-0.195||||||||-0.195|-0.616|
72457033|NCT01263496|144437008|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.583|||||TWO_SIDED|95.0|-0.78|-0.386||||||||-0.386|-0.780|
72457034|NCT01263496|144437009|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.172|||||TWO_SIDED|95.0|-0.41|0.065||||||||0.065|-0.410|
72457035|NCT01263496|144437009|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.319|||||TWO_SIDED|95.0|-0.55|-0.088||||||||-0.088|-0.550|
72457036|NCT01263496|144437009|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.37|||||TWO_SIDED|95.0|-0.601|-0.139||||||||-0.139|-0.601|
72457037|NCT01263496|144437009|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.533|||||TWO_SIDED|95.0|-0.752|-0.314||||||||-0.314|-0.752|
72457038|NCT01263496|144437010|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.079|||||TWO_SIDED|95.0|-0.323|0.166||||||||0.166|-0.323|
72457039|NCT01263496|144437010|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.241|||||TWO_SIDED|95.0|-0.471|-0.011||||||||-0.011|-0.471|
72457040|NCT01263496|144437010|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.357|||||TWO_SIDED|95.0|-0.59|-0.124||||||||-0.124|-0.590|
72457041|NCT01263496|144437010|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.467|||||TWO_SIDED|95.0|-0.692|-0.242||||||||-0.242|-0.692|
72457042|NCT01263496|144437011|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.08|||||TWO_SIDED|95.0|-0.321|0.162||||||||0.162|-0.321|
72457043|NCT01263496|144437011|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.294|||||TWO_SIDED|95.0|-0.542|-0.046||||||||-0.046|-0.542|
72457044|NCT01263496|144437011|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.341|||||TWO_SIDED|95.0|-0.579|-0.103||||||||-0.103|-0.579|
72457045|NCT01263496|144437011|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.487|||||TWO_SIDED|95.0|-0.722|-0.252||||||||-0.252|-0.722|
72457046|NCT01263496|144437012|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.049|||||TWO_SIDED|95.0|-0.279|0.182||||||||0.182|-0.279|
72457047|NCT01263496|144437012|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.234|||||TWO_SIDED|95.0|-0.491|0.023||||||||0.023|-0.491|
72457048|NCT01263496|144437012|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.375|||||TWO_SIDED|95.0|-0.605|-0.145||||||||-0.145|-0.605|
72457049|NCT01263496|144437012|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.488|||||TWO_SIDED|95.0|-0.724|-0.252||||||||-0.252|-0.724|
72457050|NCT01263496|144437013|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.05|||||TWO_SIDED|95.0|-0.27|0.169||||||||0.169|-0.270|
72457051|NCT01263496|144437013|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.193|||||TWO_SIDED|95.0|-0.453|0.067||||||||0.067|-0.453|
72457052|NCT01263496|144437013|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.374|||||TWO_SIDED|95.0|-0.596|-0.152||||||||-0.152|-0.596|
72457053|NCT01263496|144437013|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.49|||||TWO_SIDED|95.0|-0.723|-0.256||||||||-0.256|-0.723|
72457054|NCT01263496|144437014|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.065|||||TWO_SIDED|95.0|-0.16|0.289||||||||0.289|-0.160|
72457055|NCT01263496|144437014|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.236|||||TWO_SIDED|95.0|-0.477|0.005||||||||0.005|-0.477|
72457056|NCT01263496|144437014|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.36|||||TWO_SIDED|95.0|-0.608|-0.113||||||||-0.113|-0.608|
72457057|NCT01263496|144437014|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.435|||||TWO_SIDED|95.0|-0.679|-0.191||||||||-0.191|-0.679|
72457058|NCT01263496|144437015|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.033|||||TWO_SIDED|95.0|-0.262|0.196||||||||0.196|-0.262|
72457059|NCT01263496|144437015|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.262|||||TWO_SIDED|95.0|-0.516|-0.008||||||||-0.008|-0.516|
72457060|NCT01263496|144437015|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.358|||||TWO_SIDED|95.0|-0.614|-0.103||||||||-0.103|-0.614|
72457061|NCT01263496|144437015|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.432|||||TWO_SIDED|95.0|-0.69|-0.174||||||||-0.174|-0.690|
72457062|NCT01263496|144437016|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.118|||||TWO_SIDED|95.0|-0.346|0.11||||||||0.110|-0.346|
72457063|NCT01263496|144437016|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.277|||||TWO_SIDED|95.0|-0.539|-0.015||||||||-0.015|-0.539|
72457064|NCT01263496|144437016|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.373|||||TWO_SIDED|95.0|-0.637|-0.109||||||||-0.109|-0.637|
72457065|NCT01263496|144437016|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.477|||||TWO_SIDED|95.0|-0.741|-0.213||||||||-0.213|-0.741|
72457066|NCT01263496|144437017|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.181|||||TWO_SIDED|95.0|-0.416|0.055||||||||0.055|-0.416|
72457067|NCT01263496|144437017|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.245|||||TWO_SIDED|95.0|-0.492|0.003||||||||0.003|-0.492|
72457068|NCT01263496|144437017|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.408|||||TWO_SIDED|95.0|-0.654|-0.161||||||||-0.161|-0.654|
72457069|NCT01263496|144437017|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.638|||||TWO_SIDED|95.0|-0.874|-0.402||||||||-0.402|-0.874|
72457070|NCT01263496|144437018|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.51|||||TWO_SIDED|95.0|-17.56|0.54||||||||0.54|-17.56|
72457071|NCT01263496|144437018|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.7|||||TWO_SIDED|95.0|-19.23|-4.18||||||||-4.18|-19.23|
72457072|NCT01263496|144437018|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.41|||||TWO_SIDED|95.0|-20.68|-6.15||||||||-6.15|-20.68|
72457073|NCT01263496|144437018|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.38|||||TWO_SIDED|95.0|-26.93|-11.83||||||||-11.83|-26.93|
72457074|NCT01263496|144437019|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.44|||||TWO_SIDED|95.0|-12.67|3.8||||||||3.80|-12.67|
72457075|NCT01263496|144437019|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.39|||||TWO_SIDED|95.0|-17.48|-1.3||||||||-1.30|-17.48|
72457076|NCT01263496|144437019|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.56|||||TWO_SIDED|95.0|-18.58|-2.54||||||||-2.54|-18.58|
72457077|NCT01263496|144437019|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.37|||||TWO_SIDED|95.0|-21.44|-3.31||||||||-3.31|-21.44|
72457078|NCT01263496|144437020|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.9|||||TWO_SIDED|95.0|-15.66|1.86||||||||1.86|-15.66|
72457079|NCT01263496|144437020|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.73|||||TWO_SIDED|95.0|-18.97|-2.49||||||||-2.49|-18.97|
72457080|NCT01263496|144437020|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.21|||||TWO_SIDED|95.0|-17.2|-1.23||||||||-1.23|-17.20|
72457081|NCT01263496|144437020|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.49|||||TWO_SIDED|95.0|-24.27|-6.72||||||||-6.72|-24.27|
72457082|NCT01263496|144437021|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.27|||||TWO_SIDED|95.0|-11.22|6.67||||||||6.67|-11.22|
72457083|NCT01263496|144437021|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.36|||||TWO_SIDED|95.0|-12.16|5.44||||||||5.44|-12.16|
72457084|NCT01263496|144437021|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.43|||||TWO_SIDED|95.0|-13.3|2.44||||||||2.44|-13.30|
72457085|NCT01263496|144437021|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.9|||||TWO_SIDED|95.0|-20.74|-3.06||||||||-3.06|-20.74|
72457086|NCT01263496|144437022|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.44|||||TWO_SIDED|95.0|-11.97|7.08||||||||7.08|-11.97|
72457087|NCT01263496|144437022|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.25|||||TWO_SIDED|95.0|-15.84|3.35||||||||3.35|-15.84|
72457088|NCT01263496|144437022|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.93|||||TWO_SIDED|95.0|-15.28|1.41||||||||1.41|-15.28|
72457089|NCT01263496|144437022|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.73|||||TWO_SIDED|95.0|-22.67|-2.78||||||||-2.78|-22.67|
72457090|NCT01263496|144437023|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.44|||||TWO_SIDED|95.0|-13.19|2.31||||||||2.31|-13.19|
72457091|NCT01263496|144437023|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.77|||||TWO_SIDED|95.0|-13.53|5.99||||||||5.99|-13.53|
72457092|NCT01263496|144437023|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.85|||||TWO_SIDED|95.0|-14.36|2.67||||||||2.67|-14.36|
72457093|NCT01263496|144437023|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.22|||||TWO_SIDED|95.0|-20.72|-1.73||||||||-1.73|-20.72|
72457094|NCT01263496|144437024|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.26|||||TWO_SIDED|95.0|-10.42|5.9||||||||5.90|-10.42|
72457095|NCT01263496|144437024|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.9|||||TWO_SIDED|95.0|-15.64|3.84||||||||3.84|-15.64|
72457096|NCT01263496|144437024|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.47|||||TWO_SIDED|95.0|-16.52|-0.42||||||||-0.42|-16.52|
72457097|NCT01263496|144437024|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.47|||||TWO_SIDED|95.0|-22.18|-2.76||||||||-2.76|-22.18|
72457098|NCT01263496|144437025|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.34|||||TWO_SIDED|95.0|-7.1|7.77||||||||7.77|-7.10|
72457099|NCT01263496|144437025|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.98|||||TWO_SIDED|95.0|-10.16|8.21||||||||8.21|-10.16|
72457100|NCT01263496|144437025|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.88|||||TWO_SIDED|95.0|-9.71|5.95||||||||5.95|-9.71|
72457101|NCT01263496|144437025|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.38|||||TWO_SIDED|95.0|-18.59|-0.18||||||||-0.18|-18.59|
72457102|NCT01263496|144437026|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.72|||||TWO_SIDED|95.0|-10.2|6.75||||||||6.75|-10.20|
72457103|NCT01263496|144437026|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.7|||||TWO_SIDED|95.0|-13.1|5.7||||||||5.70|-13.10|
72620807|NCT02844075|144772735|SUPERIORITY||||||||||||||||||For sample size calculation, Minimax design to evaluate the null hypothesis that the true pCR rate will be 10% and the alternative hypothesis that the pCR rate≥ 30%, with type I error (α) level of 10% and type II error (β) of 0.10. If 1 or more successes are observed in the first 16 patients, accrual for that stratum will be continued until a total of 25 patients. If, of these 25 patients, 5 or more pCR, an additional investigation is warranted. Allowing for a follow-up loss rate of 10 %, the total sample size is expected as 28. For biomarker evaluation, the categorical groups were investigated to evaluated possible association with response and/or survival. Associations were analyzed by χ2 test or Fisher's exact test for categorical variables. The Kaplan-Meier method was used to analyze survival outcomes (EFS, OS, and DFS). To compare PD-L1 expression between paired pre- and post-neoadjuvant treatment with associated of pCR, the Wilcoxon signed-rank test was used.|||
72457104|NCT01263496|144437026|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.97|||||TWO_SIDED|95.0|-12.94|5.0||||||||5.00|-12.94|
72457105|NCT01263496|144437026|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.74|||||TWO_SIDED|95.0|-19.4|-0.08||||||||-0.08|-19.40|
72457106|NCT01263496|144437027|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.43|||||TWO_SIDED|95.0|-11.0|6.15||||||||6.15|-11.00|
72500253|NCT00824564|144530922|SUPERIORITY_OR_OTHER||Least square means difference|0.11|STANDARD_ERROR_OF_MEAN|0.276||0.686|TWO_SIDED|95.0|-0.44|0.66|||Mixed Models Analysis|||For change at day 4/ET post-surgery, a MMRM approach was used to relate the dependent (outcome) variable and independent (treatment, time point, and treatment-by-time point interaction as factors and baseline value as co-variate) variables taking into account the within-participant correlation arising from the repeated measurements.||0.66|-0.44|0.686
72500254|NCT00824564|144530923|SUPERIORITY_OR_OTHER|||||||0.241|TWO_SIDED||||||Fisher Exact|||Fisher's exact test at 5% level of significance was used as the event rate was low and the expected count for any cell in the (unstratified) 2\*2 contingency table was less than 5.||||0.241
72563014|NCT00292227|144658092|NON_INFERIORITY_OR_EQUIVALENCE|A standard deviation of 12ms was assumed for sample size calculation. Sample size was calculated to have 90% power to show the non-inferiority of rotigotine against placebo with respect to the non-inferiority margin of 10ms (α=0.05, 1-sided).|Mean Difference (Net)|-0.53||||||90.0|-2.37|1.3|||ANCOVA|The ANCOVA model included the factors site, treatment, gender, and time-matched baseline QTcI as covariate.|The direction of the estimate is Rotigotine - Placebo. Mean difference was estimated from the ANCOVA model.|The analysis was based on a non-inferiority comparison of rotigotine vs placebo using a 1-sided 95% confidence interval (or, equivalently, the upper limit of 2-sided 90% confidence interval) for the time-matched changes from Baseline in QTcI.||1.30|-2.37|
72563015|NCT00292227|144658093|NON_INFERIORITY_OR_EQUIVALENCE|A standard deviation of 12ms was assumed for sample size calculation. Sample size was calculated to have 90% power to show the non-inferiority of rotigotine against placebo with respect to the non-inferiority margin of 10ms (α=0.05, 1-sided).|Mean Difference (Net)|-0.41||||||90.0|-2.3|1.49|||ANCOVA|The ANCOVA model included the factors site, treatment, gender, and time-matched baseline QTcI as covariate.|The direction of the estimate is Rotigotine - Placebo. Mean difference was estimated from the ANCOVA model.|The analysis was based on a non-inferiority comparison of rotigotine vs placebo using a 1-sided 95% confidence interval (or, equivalently, the upper limit of 2-sided 90% confidence interval) for the time-matched changes from Baseline in QTcI.||1.49|-2.30|
72620808|NCT01887600|144772744|SUPERIORITY||Odds Ratio (OR)|34.74|||<|0.001|TWO_SIDED|95.0|20.48|58.93|||Cochran-Mantel-Haenszel||Please note Odds Ratio and CI are shown in percentages.|The Cochran-Mantel-Haenszel (CMH) test was adjusted by region, history of of cardiovascular, cerebrovascular or thromboembolic (CV) disease, baseline Hb and baseline estimated glomerular filtration rate (eGFR). Superiority of roxadustat versus placebo was to be declared if the lower bound of the two-sided 95% confidence interval of the CMH odds ratio was higher than 1.||58.93|20.48|<0.001
72620809|NCT01887600|144772745|SUPERIORITY||Least squares mean difference|1.692|||<|0.001||95.0|1.52|1.86|||ANCOVA|||The Analysis of Covariance (ANCOVA) with Multiple Imputations (MI) model, adjusting for covariates was used for the analysis. The model included treatment as fixed factor, region and history of CV disease as class factors and baseline Hb, baseline eGFR as continuous covariates. Superiority of roxadustat versus placebo was considered successful if the lower bound of the two-sided 95% confidence interval of the difference between treatment arms (roxadustat minus placebo) was higher than 0.||1.86|1.52|<0.001
72457107|NCT01263496|144437027|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.29|||||TWO_SIDED|95.0|-16.53|1.94||||||||1.94|-16.53|
72457108|NCT01263496|144437027|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.3|||||TWO_SIDED|95.0|-17.93|-0.67||||||||-0.67|-17.93|
72457109|NCT01263496|144437027|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.88|||||TWO_SIDED|95.0|-21.83|-1.93||||||||-1.93|-21.83|
72457110|NCT01263496|144437028|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.2|||||TWO_SIDED|95.0|-9.68|7.27||||||||7.27|-9.68|
72457111|NCT01263496|144437028|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.05|||||TWO_SIDED|95.0|-16.34|2.24||||||||2.24|-16.34|
72370444|NCT00488683|144251631|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|0.2||||0.08||95.0||||Values from Group 1, 2 and 3 were combined for this analysis.|Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccinations and serogroup specific IgG concentration at 12 months of age for the serogroup W-135||||0.08
72457112|NCT01263496|144437028|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.86|||||TWO_SIDED|95.0|-17.47|-0.26||||||||-0.26|-17.47|
72457113|NCT01263496|144437028|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.51|||||TWO_SIDED|95.0|-23.12|-3.89||||||||-3.89|-23.12|
72457114|NCT01263496|144437029|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.65|||||TWO_SIDED|95.0|-10.09|6.8||||||||6.80|-10.09|
72457115|NCT01263496|144437029|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.7|||||TWO_SIDED|95.0|-15.66|2.25||||||||2.25|-15.66|
72457116|NCT01263496|144437029|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.28|||||TWO_SIDED|95.0|-16.64|0.07||||||||0.07|-16.64|
72457117|NCT01263496|144437029|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-18.82|||||TWO_SIDED|95.0|-27.39|-10.24||||||||-10.24|-27.39|
72457118|NCT01263496|144437030|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.017|||||TWO_SIDED|95.0|-0.219|0.254||||||||0.254|-0.219|
72392344|NCT03782792|144292137|OTHER|||||||0.0012||||||One-sided P Value.|Wilcoxon (Mann-Whitney)|||The effect of spesolimab was evaluated by a Wilcoxon rank test using the RS. Any assessments after death, the use of escape medication (before or after Day 8), open label spesolimab on Day 8, or rescue medication with spesolimab after Day 8 were assigned worst ranks for the testing. Missing data at Week 4 were imputed and handled via assessment of ranks.|The difference between treatments, based on the RS, using a modified Hodges-Lehmann (HL) estimate of the median difference and 95% Confidence Intervals could not be calculated due to lack of valid data.|||0.0012
72392345|NCT03782792|144292138|OTHER|||||||0.0044||||||One-sided P Value.|Wilcoxon (Mann-Whitney)|||The effect of spesolimab was evaluated by a Wilcoxon rank test using the RS. Any assessments after death, the use of escape medication (before or after Day 8), open label spesolimab on Day 8, or rescue medication with spesolimab after Day 8 were assigned worst ranks for the testing. Missing data at Week 4 were imputed and handled via assessment of ranks.|The difference between treatments, based on the RS, using a modified Hodges-Lehmann (HL) estimate of the median difference and 95% Confidence Intervals could not be calculated due to lack of valid data.|||0.0044
72392346|NCT03782792|144292139|OTHER|||||||0.0012||||||One-sided P Value.|Wilcoxon (Mann-Whitney)|||The effect of spesolimab was evaluated by a Wilcoxon rank test using the RS. Any assessments after death, the use of escape medication (before or after Day 8), open label spesolimab on Day 8, or rescue medication with spesolimab after Day 8 were assigned worst ranks for the testing. Missing data at Week 4 were imputed and handled via assessment of ranks.|The difference between treatments, based on the RS, using a modified Hodges-Lehmann (HL) estimate of the median difference and 95% Confidence Intervals could not be calculated due to lack of valid data.|||0.0012
72392347|NCT03782792|144292140|OTHER||Risk Difference (RD)|0.375|||||TWO_SIDED|95.0|0.058|0.581|||||Risk difference=Response rate of spesolimab - response rate of placebo.|Confidence intervals (95%) around the risk difference were produced using the Chan and Zhang method.||0.581|0.058|
72392348|NCT03782792|144292141|OTHER||Risk Difference (RD)|0.403|||||TWO_SIDED|95.0|0.096|0.607|||||Risk difference=Response rate of spesolimab - response rate of placebo.|Confidence intervals (95%) around the risk difference were produced using the Chan and Zhang method.||0.607|0.096|
72392349|NCT03782792|144292142|OTHER||Risk Difference (RD)|0.432|||||TWO_SIDED|95.0|0.096|0.636|||||Risk difference=Response rate of spesolimab - response rate of placebo.|Confidence intervals (95%) around the risk difference were produced using the Chan and Zhang method.||0.636|0.096|
72392350|NCT03782792|144292144|OTHER||Risk Difference (RD)|0.151|||||TWO_SIDED|95.0|-0.138|0.401|||||Risk difference=Response rate of spesolimab - response rate of placebo.|Confidence intervals (95%) around the risk difference were produced using the Chan and Zhang method.||0.401|-0.138|
72392351|NCT03782792|144292145|OTHER||Median Difference (Final Values)|-16.88|||||TWO_SIDED|95.0|-67.32|12.76|||||Median difference was calculated by modified Hodges-Lehmann method.|Any assessments after death, the use of escape medication (before or after Day 8), open label spesolimab on Day 8, or rescue medication with spesolimab after Day 8 and assigned with the worst possible outcomes in rank analysis. Missing data at Week 4 were imputed and handled via assessment of ranks.||12.76|-67.32|
72392352|NCT02321800|144292182|NON_INFERIORITY|The margin of noninferiority was 20%. Noninferiority was concluded if the lower bound of a 2-sided 95% CI for the difference in response rates between the 2 treatment groups was greater than -20%. If the noninferiority inference based on the 20% margin was concluded successfully, noninferiority inference based on the 15% margin was performed.|Treatment Difference|18.58|||||TWO_SIDED|95.0|8.23|28.92||||||Adjusted estimates of the difference between the two treatment groups are based on a stratified analysis using Cochran-Mantel-Haenszel weights, with clinical diagnosis (complicated urinary tract infection with or without pyelonephritis vs acute uncomplicated pyelonephritis) as the stratification factor.||28.92|8.23|
72392353|NCT02321800|144292183|OTHER||Treatment Difference|0.66|||||TWO_SIDED|95.0|-6.48|7.79||||||Adjusted estimates of the difference between the two treatment groups are based on a stratified analysis using Cochran-Mantel-Haenszel weights, with clinical diagnosis (complicated urinary tract infection with or without pyelonephritis vs acute uncomplicated pyelonephritis) as the stratification factor.||7.79|-6.48|
72392354|NCT02321800|144292184|OTHER||Treatment Difference|0.72|||||TWO_SIDED|95.0|-3.48|4.92||||||Adjusted estimates of the difference between the two treatment groups are based on a stratified analysis using Cochran-Mantel-Haenszel weights, with clinical diagnosis (complicated urinary tract infection with or without pyelonephritis vs acute uncomplicated pyelonephritis) as the stratification factor.||4.92|-3.48|
72392355|NCT02321800|144292185|OTHER||Treatment Difference|15.31|||||TWO_SIDED|95.0|4.69|25.92||||||||25.92|4.69|
72392356|NCT02321800|144292186|OTHER||Treatment Difference|17.25|||||TWO_SIDED|95.0|6.92|27.58||||||Adjusted estimates of the difference between the two treatment groups are based on a stratified analysis using Cochran-Mantel-Haenszel weights, with clinical diagnosis (complicated urinary tract infection with or without pyelonephritis vs acute uncomplicated pyelonephritis) as the stratification factor.||27.58|6.92|
72392357|NCT02321800|144292187|OTHER||Treatment Difference|1.28|||||TWO_SIDED|95.0|-4.83|7.39||||||Adjusted estimates of the difference between the two treatment groups are based on a stratified analysis using Cochran-Mantel-Haenszel weights, with clinical diagnosis (complicated urinary tract infection with or without pyelonephritis vs acute uncomplicated pyelonephritis) as the stratification factor.||7.39|-4.83|
72392358|NCT02321800|144292188|OTHER||Treatment Difference|1.1|||||TWO_SIDED|95.0|-3.04|5.25||||||Adjusted estimates of the difference between the two treatment groups are based on a stratified analysis using Cochran-Mantel-Haenszel weights, with clinical diagnosis (complicated urinary tract infection with or without pyelonephritis vs acute uncomplicated pyelonephritis) as the stratification factor.||5.25|-3.04|
72392359|NCT02321800|144292189|OTHER||Treatment Difference|13.92|||||TWO_SIDED|95.0|3.21|24.63||||||Adjusted estimates of the difference between the two treatment groups are based on a stratified analysis using Cochran-Mantel-Haenszel weights, with clinical diagnosis (complicated urinary tract infection with or without pyelonephritis vs acute uncomplicated pyelonephritis) as the stratification factor.||24.63|3.21|
72392360|NCT02321800|144292194|OTHER||Treatment Difference|2.39|||||TWO_SIDED|95.0|-4.66|9.44||||||Adjusted estimates of the difference between the two treatment groups are based on a stratified analysis using Cochran-Mantel-Haenszel weights, with clinical diagnosis (complicated urinary tract infection with or without pyelonephritis vs acute uncomplicated pyelonephritis) as the stratification factor.||9.44|-4.66|
72457119|NCT01263496|144437030|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.226|||||TWO_SIDED|95.0|0.002|0.451||||||||0.451|0.002|
72563016|NCT00292227|144658094|NON_INFERIORITY_OR_EQUIVALENCE|A standard deviation of 12ms was assumed for sample size calculation. Sample size was calculated to have 90% power to show the non-inferiority of rotigotine against placebo with respect to the non-inferiority margin of 10ms (α=0.05, 1-sided).|Mean Difference (Net)|-0.5||||||90.0|-2.34|1.35|||ANCOVA|The ANCOVA model included the factors site, treatment, gender, and time-matched baseline QTcI as covariate.|The direction of the estimate is Rotigotine - Placebo. Mean difference was estimated from the ANCOVA model.|The analysis was based on a non-inferiority comparison of rotigotine vs placebo using a 1-sided 95% confidence interval (or, equivalently, the upper limit of 2-sided 90% confidence interval) for the time-matched changes from Baseline in QTcI.||1.35|-2.34|
72392361|NCT02321800|144292195|OTHER||Treatment Difference|-0.26|||||TWO_SIDED|95.0|-6.57|6.05||||||Adjusted estimates of the difference between the two treatment groups are based on a stratified analysis using Cochran-Mantel-Haenszel weights, with clinical diagnosis (complicated urinary tract infection with or without pyelonephritis vs acute uncomplicated pyelonephritis) as the stratification factor.||6.05|-6.57|
72457120|NCT01263496|144437030|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.23|||||TWO_SIDED|95.0|0.008|0.453||||||||0.453|0.008|
72457121|NCT01263496|144437030|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.282|||||TWO_SIDED|95.0|0.041|0.524||||||||0.524|0.041|
72457122|NCT01263496|144437031|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.09|||||TWO_SIDED|95.0|-0.173|0.353||||||||0.353|-0.173|
72457123|NCT01263496|144437031|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.228|||||TWO_SIDED|95.0|-0.01|0.467||||||||0.467|-0.010|
72457124|NCT01263496|144437031|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.339|||||TWO_SIDED|95.0|0.095|0.584||||||||0.584|0.095|
72457125|NCT01263496|144437031|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.468|||||TWO_SIDED|95.0|0.184|0.752||||||||0.752|0.184|
72457126|NCT01263496|144437032|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.317|||||TWO_SIDED|95.0|0.064|0.57||||||||0.570|0.064|
72457127|NCT01263496|144437032|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.511|||||TWO_SIDED|95.0|0.236|0.786||||||||0.786|0.236|
72457128|NCT01263496|144437032|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.437|||||TWO_SIDED|95.0|0.19|0.685||||||||0.685|0.190|
72457129|NCT01263496|144437032|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.718|||||TWO_SIDED|95.0|0.413|1.022||||||||1.022|0.413|
72457130|NCT01263496|144437033|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.226|||||TWO_SIDED|95.0|-0.029|0.481||||||||0.481|-0.029|
72457131|NCT01263496|144437033|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.358|||||TWO_SIDED|95.0|0.104|0.612||||||||0.612|0.104|
72457132|NCT01263496|144437033|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.308|||||TWO_SIDED|95.0|0.076|0.54||||||||0.540|0.076|
72457133|NCT01263496|144437033|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.331|||||TWO_SIDED|95.0|0.098|0.565||||||||0.565|0.098|
72457134|NCT01263496|144437034|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.14|||||TWO_SIDED|95.0|-0.13|0.41||||||||0.410|-0.130|
72457135|NCT01263496|144437034|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.245|||||TWO_SIDED|95.0|-0.026|0.516||||||||0.516|-0.026|
72457136|NCT01263496|144437034|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.294|||||TWO_SIDED|95.0|0.035|0.552||||||||0.552|0.035|
72457137|NCT01263496|144437034|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.329|||||TWO_SIDED|95.0|0.032|0.626||||||||0.626|0.032|
72457138|NCT01263496|144437035|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.049|||||TWO_SIDED|95.0|-0.252|0.349||||||||0.349|-0.252|
72457139|NCT01263496|144437035|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.42|||||TWO_SIDED|95.0|0.138|0.703||||||||0.703|0.138|
72457140|NCT01263496|144437035|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.46|||||TWO_SIDED|95.0|0.178|0.742||||||||0.742|0.178|
72457141|NCT01263496|144437035|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.384|||||TWO_SIDED|95.0|0.085|0.683||||||||0.683|0.085|
72457142|NCT01263496|144437036|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.035|||||TWO_SIDED|95.0|-0.257|0.326||||||||0.326|-0.257|
72457143|NCT01263496|144437036|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.249|||||TWO_SIDED|95.0|-0.043|0.542||||||||0.542|-0.043|
72457144|NCT01263496|144437036|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.111|||||TWO_SIDED|95.0|-0.196|0.417||||||||0.417|-0.196|
72457145|NCT01263496|144437036|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.333|||||TWO_SIDED|95.0|0.01|0.656||||||||0.656|0.010|
72457146|NCT01263496|144437037|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.268|||||TWO_SIDED|95.0|-0.769|0.233||||||||0.233|-0.769|
72457147|NCT01263496|144437037|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.349|||||TWO_SIDED|95.0|-0.156|0.855||||||||0.855|-0.156|
72457148|NCT01263496|144437037|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.14|||||TWO_SIDED|95.0|-0.297|0.577||||||||0.577|-0.297|
72457149|NCT01263496|144437037|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.308|||||TWO_SIDED|95.0|-0.075|0.69||||||||0.690|-0.075|
72457150|NCT01263496|144437038|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.281|||||TWO_SIDED|95.0|-0.367|0.928||||||||0.928|-0.367|
72457151|NCT01263496|144437038|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.579|||||TWO_SIDED|95.0|-0.035|1.194||||||||1.194|-0.035|
72457152|NCT01263496|144437038|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.647|||||TWO_SIDED|95.0|0.054|1.241||||||||1.241|0.054|
72457153|NCT01263496|144437038|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.252|||||TWO_SIDED|95.0|-0.28|0.785||||||||0.785|-0.280|
72457154|NCT01263496|144437039|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|||||TWO_SIDED|95.0|-1.246|0.646||||||||0.646|-1.246|
72457155|NCT01263496|144437039|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.643|||||TWO_SIDED|95.0|-0.305|1.591||||||||1.591|-0.305|
72457156|NCT01263496|144437039|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.144|||||TWO_SIDED|95.0|-0.599|0.888||||||||0.888|-0.599|
72457157|NCT01263496|144437039|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.25|||||TWO_SIDED|95.0|-0.673|1.173||||||||1.173|-0.673|
72457158|NCT01263496|144437040|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.95|||||TWO_SIDED|95.0|-4.462|2.562||||||||2.562|-4.462|
72457159|NCT01263496|144437040|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.033|||||TWO_SIDED|95.0|-2.712|2.779||||||||2.779|-2.712|
72457160|NCT01263496|144437040|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6|||||TWO_SIDED|95.0|-3.273|2.073||||||||2.073|-3.273|
72392362|NCT02321800|144292196|OTHER||Treatment Difference|-1.07|||||TWO_SIDED|95.0|-3.42|1.29||||||Adjusted estimates of the difference between the two treatment groups are based on a stratified analysis using Cochran-Mantel-Haenszel weights, with clinical diagnosis (complicated urinary tract infection with or without pyelonephritis vs acute uncomplicated pyelonephritis) as the stratification factor.||1.29|-3.42|
72392363|NCT02321800|144292197|OTHER||Treatment Difference|9.02|||||TWO_SIDED|95.0|-0.37|18.41||||||Adjusted estimates of the difference between the two treatment groups are based on a stratified analysis using Cochran-Mantel-Haenszel weights, with clinical diagnosis (complicated urinary tract infection with or without pyelonephritis vs acute uncomplicated pyelonephritis) as the stratification factor.||18.41|-0.37|
72392364|NCT01537393|144292231|NON_INFERIORITY|The two treatment groups will be declared equivalent if the one-sided 95% confidence interval for the difference in proportions excludes the pre-defined non-inferiority limit of 4%.|Risk Difference (RD)|3.2|||||ONE_SIDED|95.0||5.4|||||||The bootstrap re-sampling technique were used to account for potentially correlated data from donors who donated both corneas in this study and potentially correlated data from 2 study eyes of the same study participant. The technique will sample with replacement from the observed dataset. Confidence intervals will be calculated using the bias-corrected and accelerated method. The number of bootstraps will be 100,000.|5.4||
72392365|NCT01537393|144292231|OTHER|Confounding and treatment interactions were assessed in Cox proportional hazards regression models|Hazard Ratio (HR)|1.71||||0.02|TWO_SIDED|95.0|1.09|2.71|||Regression, Cox|Unadjusted Hazard Ratio||||2.71|1.09|0.02
72457161|NCT01263496|144437040|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|||||TWO_SIDED|95.0|-2.874|2.074||||||||2.074|-2.874|
72457162|NCT01263496|144437041|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.159|||||TWO_SIDED|95.0|-0.14|0.458||||||||0.458|-0.140|
72457163|NCT01263496|144437041|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.26|||||TWO_SIDED|95.0|-0.001|0.52||||||||0.520|-0.001|
72457164|NCT01263496|144437041|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.136|||||TWO_SIDED|95.0|-0.126|0.398||||||||0.398|-0.126|
72457165|NCT01263496|144437041|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.298|||||TWO_SIDED|95.0|0.042|0.553||||||||0.553|0.042|
72457166|NCT01263496|144437042|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.92|||||TWO_SIDED|95.0|-11.82|7.99||||||||7.99|-11.82|
72457167|NCT01263496|144437042|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.02|||||TWO_SIDED|95.0|-12.45|6.4||||||||6.40|-12.45|
72457168|NCT01263496|144437042|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.41|||||TWO_SIDED|95.0|-18.77|1.96||||||||1.96|-18.77|
72457169|NCT01263496|144437042|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.96|||||TWO_SIDED|95.0|-18.35|0.44||||||||0.44|-18.35|
72457170|NCT01263496|144437043|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.66|||||TWO_SIDED|95.0|-3.88|19.19||||||||19.19|-3.88|
72457171|NCT01263496|144437043|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.08|||||TWO_SIDED|95.0|-11.41|9.24||||||||9.24|-11.41|
72457172|NCT01263496|144437043|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.08|||||TWO_SIDED|95.0|-12.91|10.75||||||||10.75|-12.91|
72457173|NCT01263496|144437043|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.66|||||TWO_SIDED|95.0|-11.32|9.99||||||||9.99|-11.32|
72457174|NCT01263496|144437044|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.7|||||TWO_SIDED|95.0|-7.09|16.49||||||||16.49|-7.09|
72457175|NCT01263496|144437044|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.63|||||TWO_SIDED|95.0|-8.63|11.89||||||||11.89|-8.63|
72457176|NCT01263496|144437044|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.69|||||TWO_SIDED|95.0|-13.36|7.98||||||||7.98|-13.36|
72457177|NCT01263496|144437044|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.2|||||TWO_SIDED|95.0|-20.58|2.17||||||||2.17|-20.58|
72457178|NCT01263496|144437045|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8|||||TWO_SIDED|95.0|-11.44|9.84||||||||9.84|-11.44|
72457179|NCT01263496|144437045|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.04|||||TWO_SIDED|95.0|-11.74|7.66||||||||7.66|-11.74|
72457180|NCT01263496|144437045|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.44|||||TWO_SIDED|95.0|-15.62|4.75||||||||4.75|-15.62|
72457181|NCT01263496|144437045|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.28|||||TWO_SIDED|95.0|-23.83|-2.74||||||||-2.74|-23.83|
72457182|NCT01263496|144437046|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.02|||||TWO_SIDED|95.0|-28.15|14.1||||||||14.10|-28.15|
72457183|NCT01263496|144437046|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.45|||||TWO_SIDED|95.0|-23.93|13.02||||||||13.02|-23.93|
72457184|NCT01263496|144437046|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.8|||||TWO_SIDED|95.0|-35.46|-0.13||||||||-0.13|-35.46|
72457185|NCT01263496|144437046|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-30.58|||||TWO_SIDED|95.0|-47.75|-13.41||||||||-13.41|-47.75|
72457186|NCT01263496|144437047|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|18.45|||||TWO_SIDED|95.0|-5.18|42.09||||||||42.09|-5.18|
72457187|NCT01263496|144437047|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.86|||||TWO_SIDED|95.0|-13.56|33.28||||||||33.28|-13.56|
72457188|NCT01263496|144437047|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.44|||||TWO_SIDED|95.0|-30.25|15.37||||||||15.37|-30.25|
72457189|NCT01263496|144437047|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.8|||||TWO_SIDED|95.0|-34.75|9.15||||||||9.15|-34.75|
72457190|NCT01263496|144437048|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.84|||||TWO_SIDED|95.0|-13.9|25.58||||||||25.58|-13.90|
72457191|NCT01263496|144437048|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.35|||||TWO_SIDED|95.0|-18.2|24.9||||||||24.90|-18.20|
72457192|NCT01263496|144437048|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.64|||||TWO_SIDED|95.0|-26.03|18.74||||||||18.74|-26.03|
72457193|NCT01263496|144437048|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-23.37|||||TWO_SIDED|95.0|-47.08|0.34||||||||0.34|-47.08|
72457194|NCT01263496|144437049|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.97|||||TWO_SIDED|95.0|-18.77|24.71||||||||24.71|-18.77|
72457195|NCT01263496|144437049|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.37|||||TWO_SIDED|95.0|-21.21|23.94||||||||23.94|-21.21|
72457196|NCT01263496|144437049|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.2|||||TWO_SIDED|95.0|-32.69|10.3||||||||10.30|-32.69|
72457197|NCT01263496|144437049|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-34.9|||||TWO_SIDED|95.0|-56.85|-12.96||||||||-12.96|-56.85|
72457198|NCT01263496|144437050|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.955|||||TWO_SIDED|95.0|0.375|1.535||||||||1.535|0.375|
72457199|NCT01263496|144437050|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.358|||||TWO_SIDED|95.0|0.752|1.965||||||||1.965|0.752|
72457200|NCT01263496|144437050|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.35|||||TWO_SIDED|95.0|0.724|1.975||||||||1.975|0.724|
72620810|NCT01887600|144772746|SUPERIORITY||Least squares mean difference|1.599|||<|0.001|TWO_SIDED|95.0|1.41|1.78||LSM Difference p-value is for test of differences. Tested using a fixed sequence testing procedure to maintain the overall two-sided type I error rate at 0.05.|Mixed Models Analysis|||The model includes treatment, visit, visit by treatment interaction, region and history of CV disease as fixed class factors and baseline Hb, baseline eGFR and baseline Hb by visit interaction as continuous covariates.||1.78|1.41|<0.001
72620811|NCT01887600|144772747|SUPERIORITY|Superiority of roxadustat versus placebo was considered successful if the upper bound of the two-sided 95% confidence interval of the difference between treatment arms (roxadustat minus placebo) is below 0.|Least squares mean difference|-0.701|||<|0.001||95.0|-0.83|-0.57||LSM Difference p-value is for test of differences. Tested using a fixed sequence testing procedure to maintain the overall two-sided type I error rate at 0.05.|Mixed Models Analysis|||A Mixed Model of Repeated Measures has been applied up to week 28. The results were based on the estimated difference between the two treatment arms and overall mean effects during the period (weeks 12 to 28). The model included treatment arm, region, CV history, visits and visit by treatment as categorical variables and baseline Hb, baseline eGFR and baseline LDL as continuous variables.||-0.57|-0.83|<0.001
72457201|NCT01263496|144437050|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.38|||||TWO_SIDED|95.0|0.804|1.955||||||||1.955|0.804|
72457202|NCT01263496|144437051|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.034|||||TWO_SIDED|95.0|0.344|1.723||||||||1.723|0.344|
72457203|NCT01263496|144437051|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.448|||||TWO_SIDED|95.0|0.78|2.115||||||||2.115|0.780|
72457204|NCT01263496|144437051|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.243|||||TWO_SIDED|95.0|0.616|1.87||||||||1.870|0.616|
72457205|NCT01263496|144437051|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.481|||||TWO_SIDED|95.0|0.827|2.136||||||||2.136|0.827|
72457206|NCT01263496|144437052|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.05|||||TWO_SIDED|95.0|-4.088|4.188||||||||4.188|-4.088|
72457207|NCT01263496|144437052|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.585|||||TWO_SIDED|95.0|-3.476|6.647||||||||6.647|-3.476|
72457208|NCT01263496|144437052|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.517|||||TWO_SIDED|95.0|-8.151|9.184||||||||9.184|-8.151|
72457209|NCT01263496|144437052|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.277|||||TWO_SIDED|95.0|-2.191|4.744||||||||4.744|-2.191|
72500255|NCT01552057|144530927|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.32||||0.0988|TWO_SIDED|95.0|-0.7|0.06||Statistical tests were conducted at a 2-sided alpha level of 0.05.|MMRM|||||0.06|-0.70|0.0988
72457210|NCT01263496|144437053|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.841|||||TWO_SIDED|95.0|0.239|1.443||||||||1.443|0.239|
72457211|NCT01263496|144437053|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.304|||||TWO_SIDED|95.0|0.679|1.93||||||||1.930|0.679|
72457212|NCT01263496|144437053|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.992|||||TWO_SIDED|95.0|0.4|1.585||||||||1.585|0.400|
72457213|NCT01263496|144437053|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.263|||||TWO_SIDED|95.0|0.674|1.853||||||||1.853|0.674|
72457214|NCT01263496|144437054|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|15.891|||||TWO_SIDED|95.0|9.597|22.184||||||||22.184|9.597|
72457215|NCT01263496|144437054|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|18.026|||||TWO_SIDED|95.0|12.466|23.585||||||||23.585|12.466|
72457216|NCT01263496|144437054|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|19.838|||||TWO_SIDED|95.0|14.379|25.297||||||||25.297|14.379|
72457217|NCT01263496|144437054|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|15.368|||||TWO_SIDED|95.0|8.677|22.06||||||||22.060|8.677|
72457218|NCT01263496|144437055|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.323|||||TWO_SIDED|95.0|6.567|22.079||||||||22.079|6.567|
72457219|NCT01263496|144437055|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|20.714|||||TWO_SIDED|95.0|14.563|26.864||||||||26.864|14.563|
72457220|NCT01263496|144437055|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|19.063|||||TWO_SIDED|95.0|13.125|25.002||||||||25.002|13.125|
72457221|NCT01263496|144437055|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|15.233|||||TWO_SIDED|95.0|6.618|23.847||||||||23.847|6.618|
72457222|NCT01263496|144437056|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.047|||||TWO_SIDED|95.0|1.169|14.924||||||||14.924|1.169|
72457223|NCT01263496|144437056|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.95|||||TWO_SIDED|95.0|7.767|20.133||||||||20.133|7.767|
72457224|NCT01263496|144437056|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|15.221|||||TWO_SIDED|95.0|9.191|21.251||||||||21.251|9.191|
72457225|NCT01263496|144437056|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.366|||||TWO_SIDED|95.0|5.847|20.885||||||||20.885|5.847|
72457226|NCT01263496|144437057|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.719|||||TWO_SIDED|95.0|1.657|13.782||||||||13.782|1.657|
72457227|NCT01263496|144437057|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.978|||||TWO_SIDED|95.0|7.556|18.399||||||||18.399|7.556|
72457228|NCT01263496|144437057|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|15.076|||||TWO_SIDED|95.0|9.808|20.345||||||||20.345|9.808|
72457229|NCT01263496|144437057|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.087|||||TWO_SIDED|95.0|6.561|19.614||||||||19.614|6.561|
72457230|NCT01263496|144437058|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.76|||||TWO_SIDED|95.0|-7.03|20.55||||||||20.55|-7.03|
72457231|NCT01263496|144437058|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.85|||||TWO_SIDED|95.0|-1.49|25.19||||||||25.19|-1.49|
72457232|NCT01263496|144437058|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.72|||||TWO_SIDED|95.0|-5.12|24.56||||||||24.56|-5.12|
72457233|NCT01263496|144437058|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.82|||||TWO_SIDED|95.0|-13.26|14.9||||||||14.90|-13.26|
72457234|NCT01263496|144437059|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.9|||||TWO_SIDED|95.0|-11.11|22.91||||||||22.91|-11.11|
72457235|NCT01263496|144437059|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.57|||||TWO_SIDED|95.0|-7.21|28.35||||||||28.35|-7.21|
72457236|NCT01263496|144437059|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.45|||||TWO_SIDED|95.0|-10.08|26.98||||||||26.98|-10.08|
72457237|NCT01263496|144437059|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.82|||||TWO_SIDED|95.0|-10.67|24.3||||||||24.30|-10.67|
72457238|NCT01263496|144437060|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.09|||||TWO_SIDED|95.0|-14.95|21.13||||||||21.13|-14.95|
72457239|NCT01263496|144437060|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.48|||||TWO_SIDED|95.0|-15.61|20.57||||||||20.57|-15.61|
72457240|NCT01263496|144437060|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.66|||||TWO_SIDED|95.0|-21.0|19.68||||||||19.68|-21.00|
72457241|NCT01263496|144437060|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.29|||||TWO_SIDED|95.0|-17.47|20.05||||||||20.05|-17.47|
72457242|NCT01263496|144437061|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.08|||||TWO_SIDED|95.0|-11.7|19.86||||||||19.86|-11.70|
72457243|NCT01263496|144437061|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.94|||||TWO_SIDED|95.0|-11.14|21.03||||||||21.03|-11.14|
72457244|NCT01263496|144437061|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.65|||||TWO_SIDED|95.0|-14.42|21.73||||||||21.73|-14.42|
72457245|NCT01263496|144437061|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.68|||||TWO_SIDED|95.0|-17.24|15.89||||||||15.89|-17.24|
72457246|NCT00046475|144437062|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||The P-value is based on an ANOVA model with post-treatment responses for OHSA Item 1 as dependent variable, treatment, sequence, period (Visit 5 or 6), as fixed effects, and patient within sequence as random effect.|ANOVA|||||||<0.001
72620812|NCT01887600|144772748|SUPERIORITY||Hazard Ratio (HR)|0.238|||<|0.001|TWO_SIDED|95.0|0.17|0.33||Tested using a fixed sequence testing procedure to maintain the overall two-sided type I error rate at 0.05.|Regression, Cox|||Hazard ratio was calculated using stratified Cox Proportional Hazards Regression stratifying on CV history and region and adjusting on Hb and eGFR at baseline as continuous covariates. Superiority is declared if the upper bound of the 95% CI is below 1.0.||0.33|0.17|<0.001
72500256|NCT01552057|144530928|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.49||||0.0003|TWO_SIDED|95.0|-0.76|-0.22||Statistical tests were conducted at a 2-sided alpha level of 0.05.|MMRM|||||-0.22|-0.76|0.0003
72500257|NCT01552057|144530929|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.44||||0.0012|TWO_SIDED|95.0|-0.71|-0.18||Statistical tests were conducted at a 2-sided alpha level of 0.05.|MMRM|||||-0.18|-0.71|0.0012
72457247|NCT00046475|144437063|SUPERIORITY_OR_OTHER_LEGACY|||||||0.011|TWO_SIDED|||||The P-value is based on an ANOVA model with post-treatment responses for OHSA Item as dependent variable, treatment, sequence, period (Visit 5 or 6), as fixed effects, and patient within sequence as random effect.|ANOVA|||||||0.011
72457248|NCT00046475|144437064|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||The P-value is based on an ANOVA model with post-treatment responses for OHSA Item 2 as dependent variable, treatment, sequence, period (Visit 5 or 6), as fixed effects, and patient within sequence as random effect.|ANOVA|||Analysis of Item 2||||<0.001
72457249|NCT00046475|144437064|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002|TWO_SIDED|||||The P-value is based on an ANOVA model with post-treatment responses for OHSA Item 3 as dependent variable, treatment, sequence, period (Visit 5 or 6), as fixed effects, and patient within sequence as random effect.|ANOVA|||Analysis of Item 3||||0.002
72457250|NCT00046475|144437064|SUPERIORITY_OR_OTHER_LEGACY|||||||0.004|TWO_SIDED|||||The P-value is based on an ANOVA model with post-treatment responses for OHSA Item 4 as dependent variable, treatment, sequence, period (Visit 5 or 6), as fixed effects, and patient within sequence as random effect.|ANOVA|||Analysis of Item 4||||0.004
72457251|NCT00046475|144437064|SUPERIORITY_OR_OTHER_LEGACY|||||||0.026|TWO_SIDED|||||The P-value is based on an ANOVA model with post-treatment responses for OHSA Item 5 as dependent variable, treatment, sequence, period (Visit 5 or 6), as fixed effects, and patient within sequence as random effect.|ANOVA|||Analysis of Item 5||||0.026
72457252|NCT00046475|144437064|SUPERIORITY_OR_OTHER_LEGACY|||||||0.226|TWO_SIDED|||||The P-value is based on an ANOVA model with post-treatment responses for OHSA Item 6 as dependent variable, treatment, sequence, period (Visit 5 or 6), as fixed effects, and patient within sequence as random effect.|ANOVA|||Analysis of Item 6||||0.226
72457253|NCT00046475|144437065|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002|TWO_SIDED|||||The P-value is based on an ANOVA model with post-treatment composite symptom score as dependent variable, treatment, sequence, period (Visit 5 or 6), as fixed effects, and patient within sequence as random effect.|ANOVA|||||||0.002
72457254|NCT00046475|144437066|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||The P-value is based on an ANOVA model with post-treatment responses for OHDAS Item 1 as dependent variable, treatment, sequence, period (Visit 5 or 6), as fixed effects, and patient within sequence as random effect.|ANOVA|||Analysis of Item 1||||<0.001
72457255|NCT00046475|144437066|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||The P-value is based on an ANOVA model with post-treatment responses for OHDAS Item 2 as dependent variable, treatment, sequence, period (Visit 5 or 6), as fixed effects, and patient within sequence as random effect.|ANOVA|||Analysis of Item 2||||<0.001
72457256|NCT00046475|144437066|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||P-value is based on an ANOVA model with post-treatment responses for OHDAS Item 3 as dependent variable, treatment, sequence, period (Visit 5 or 6), as fixed effects, and patient within sequence as random effect.|ANOVA|||Analysis of Item 3||||<0.001
72457257|NCT00046475|144437066|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|TWO_SIDED|||||The P-value is based on an ANOVA model with post-treatment responses for OHDAS Item 4 as dependent variable, treatment, sequence, period (Visit 5 or 6), as fixed effects, and patient within sequence as random effect.|ANOVA|||Analysis of Item 4||||0.001
72457258|NCT00046475|144437067|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||The P-value is based on an ANOVA model with post-treatment global daily activity score as dependent variable, treatment, sequence, period (Visit 5 or 6), as fixed effects, and patient within sequence as random effect.|ANOVA|||||||<0.001
72457259|NCT00046475|144437070|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002|TWO_SIDED|||||The P-value is based on an ANOVA model with change from baseline standing systolic blood pressure as dependent variable, treatment, sequence, period (Visit 5 or 6), as fixed effects, and patient within sequence as random effect.|ANOVA|||Analysis of standing systolic blood pressure||||0.002
72457260|NCT00046475|144437070|SUPERIORITY_OR_OTHER_LEGACY|||||||0.01|TWO_SIDED|||||The P-value is based on an ANOVA model with change from baseline standing diastolic blood pressure as dependent variable, treatment, sequence, period (Visit 5 or 6), as fixed effects, and patient within sequence as random effect.|ANOVA|||Analysis of standing diastolic blood pressure||||0.010
72457261|NCT00046475|144437071|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||The P-value is based on an ANOVA model with change from baseline supine systolic blood pressure as dependent variable, treatment, sequence, period (Visit 5 or 6), as fixed effects, and patient within sequence as random effect.|ANOVA|||Analysis of supine systolic blood pressure||||<0.001
72457262|NCT00046475|144437071|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002|TWO_SIDED|||||The P-value is based on an ANOVA model with change from baseline supine diastolic blood pressure as dependent variable, treatment, sequence, period (Visit 5 or 6), as fixed effects, and patient within sequence as random effect.|ANOVA|||Analysis of supine diastolic blood pressure||||0.002
72457263|NCT00046475|144437072|SUPERIORITY_OR_OTHER_LEGACY|||||||0.569|TWO_SIDED|||||The P-value is based on an ANOVA model with SF-36 general health score as dependent variable, treatment, sequence, period (Visit 5 or 6), as fixed effects, and patient within sequence as random effect.|ANOVA|||Analysis of general health||||0.569
72457264|NCT00046475|144437072|SUPERIORITY_OR_OTHER_LEGACY|||||||0.578|TWO_SIDED|||||The P-value is based on an ANOVA model with SF-36 physical functioning score as dependent variable, treatment, sequence, period (Visit 5 or 6), as fixed effects, and patient within sequence as random effect.|ANOVA|||Analysis of physical functioning||||0.578
72457265|NCT00046475|144437076|SUPERIORITY_OR_OTHER_LEGACY|||||||0.37|TWO_SIDED|||||The p-value is based on an ANOVA model with post-treatment responses for OHSA Item 1 as dependent variable, treatment, sequence, period (Visit 5 or 6), as fixed effects, and subject-within sequence as random effect.|ANOVA|||Analysis of US participants with mild or moderate disease severity||||0.370
72457266|NCT00046475|144437077|SUPERIORITY_OR_OTHER_LEGACY|||||||0.007|TWO_SIDED|||||The p-value is based on an ANOVA model with post-treatment responses for OHSA Item 1 as dependent variable, treatment, sequence, period (Visit 5 or 6), as fixed effects, and subject-within sequence as random effect.|ANOVA|||Analysis of US participants with marked or severe disease severity||||0.007
72457267|NCT02203032|144437087|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Row mean score test|||||||< 0.001
72457268|NCT02203032|144437088|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Row mean score test|||||||< 0.001
72457269|NCT02203032|144437089|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Row mean score test|||||||< 0.001
72457270|NCT02203032|144437090|SUPERIORITY_OR_OTHER||||||=|0.001|||||||Cochran-Mantel-Haenszel|||||||= 0.001
72457271|NCT01915914|144437091|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|13.4993|||<|0.0001|TWO_SIDED|95.0|4.1113|44.325|||Log Rank|||||44.3250|4.1113|<0.0001
72457272|NCT01915914|144437092|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|4.9524|||<|0.0001|TWO_SIDED|95.0|2.4258|10.1105|||Log Rank|||||10.1105|2.4258|<0.0001
72457273|NCT01915914|144437093|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Fisher Exact|||||||<0.0001
72457274|NCT01915914|144437094|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Chi-squared|||||||<0.0001
72457275|NCT01915914|144437096|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||||||<0.0001
72457276|NCT01915914|144437097|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||||||<0.0001
72457277|NCT01915914|144437102|SUPERIORITY_OR_OTHER|||||||0.701||95.0||||Week 20, CA|Wilcoxon (Mann-Whitney)|||||||0.7010
72457278|NCT01915914|144437102|SUPERIORITY_OR_OTHER|||||||0.0042||95.0||||Week 20, ET/L|Wilcoxon (Mann-Whitney)|||||||0.0042
72457279|NCT01915914|144437102|SUPERIORITY_OR_OTHER|||||||0.081||95.0||||Week 20, AP|Wilcoxon (Mann-Whitney)|||||||0.0810
72457280|NCT01915914|144437102|SUPERIORITY_OR_OTHER|||||||0.2799||95.0||||Week 32, CA|Wilcoxon (Mann-Whitney)|||||||0.2799
72457281|NCT01915914|144437102|SUPERIORITY_OR_OTHER|||||||0.1375||95.0||||Week 32, ET/L|Wilcoxon (Mann-Whitney)|||||||0.1375
72457282|NCT01915914|144437102|SUPERIORITY_OR_OTHER|||||||0.11||95.0||||Week 32, AP|Wilcoxon (Mann-Whitney)|||||||0.1100
72500258|NCT01552057|144530930|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.35||||0.0073|TWO_SIDED|95.0|-9.26|-1.45||Statistical tests were conducted at a 2-sided alpha level of 0.05.|MMRM|||||-1.45|-9.26|0.0073
72457283|NCT01915914|144437102|SUPERIORITY_OR_OTHER|||||||0.0394||95.0||||Week 20, Total VAS Score|Wilcoxon (Mann-Whitney)|||||||0.0394
72457284|NCT01915914|144437102|SUPERIORITY_OR_OTHER|||||||0.2237||95.0||||Week 32, Total VAS Score|Wilcoxon (Mann-Whitney)|||||||0.2237
72457285|NCT01528605|144437103|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||The null hypothesis was no group difference||||<0.05
72457286|NCT01528605|144437104|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||The null hypothesis was no group difference||||<0.05
72457287|NCT01528605|144437105|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||"The null hypothesis is no group difference"||||>0.05
72457288|NCT02432274|144437129|OTHER||||||=|0.20359|||||||Wilcoxon Rank-Sum Test|||C2D1: FGF 19 (PFS-4, Yes) vs. C2D1: FGF 19 (PFS-4, No)||||=0.20359
72457289|NCT02432274|144437129|OTHER||||||=|0.50068|||||||Wilcoxon Rank-Sum Test|||C2D1: FGF 19 (PFS-4, Yes) vs. C2D1: FGF 19 (PFS-4, No)||||=0.50068
72457290|NCT02432274|144437129|OTHER||||||=|0.05512|||||||Wilcoxon Rank-Sum Test|||C3D1: FGF 19 (PFS-4, Yes) vs. C3D1: FGF 19 (PFS-4, No)||||=0.05512
72457291|NCT02432274|144437129|OTHER||||||=|0.50382|||||||Wilcoxon Rank-Sum Test|||C4D1: FGF 19 (PFS-4, Yes) vs. C4D1: FGF 19 (PFS-4, No)||||=0.50382
72457292|NCT02432274|144437129|OTHER||||||=|0.0476|||||||Wilcoxon Rank-Sum Test|||C2D1: FGF 21 (PFS-4, Yes) vs. C2D1: FGF 21 (PFS-4, No)||||=0.04760
72457293|NCT02432274|144437129|OTHER||||||=|0.2142|||||||Wilcoxon Rank-Sum Test|||C2D1: FGF 21 (PFS-4, Yes) vs. C2D1: FGF 21 (PFS-4, No)||||=0.21420
72457294|NCT02432274|144437129|OTHER||||||=|0.42542|||||||Wilcoxon Rank-Sum Test|||C3D1: FGF 21 (PFS-4, Yes) vs. C3D1: FGF 21 (PFS-4, No)||||=0.42542
72457295|NCT02432274|144437129|OTHER||||||=|0.73573|||||||Wilcoxon Rank-Sum Test|||C4D1: FGF 21 (PFS-4, Yes) vs. C4D1: FGF 21 (PFS-4, No)||||=0.73573
72457296|NCT02432274|144437129|OTHER||||||=|0.35754|||||||Wilcoxon Rank-Sum Test|||C2D1: VEGF (PFS-4, Yes) vs. C2D1: VEGF (PFS-4, No)||||=0.35754
72457297|NCT02432274|144437129|OTHER||||||=|0.59903|||||||Wilcoxon Rank-Sum Test|||C2D1: VEGF (PFS-4, Yes) vs. C2D1: VEGF (PFS-4, No)||||=0.59903
72457298|NCT02432274|144437129|OTHER||||||=|1|||||||Wilcoxon Rank-Sum Test|||C3D1: VEGF (PFS-4, Yes) vs. C3D1: VEGF (PFS-4, No)||||=1.00000
72500259|NCT01552057|144530931|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.34||||0.0049|TWO_SIDED|95.0|1.32|7.35||Statistical tests were conducted at a 2-sided alpha level of 0.05.|ANCOVA|||Physical Functioning||7.35|1.32|0.0049
72457299|NCT03976323|144437180|SUPERIORITY||Hazard Ratio (HR)|1.12||||0.8721|TWO_SIDED|95.0|0.92|1.36||One-sided p-value based on log-rank test stratified by Eastern Cooperative Oncology Group (ECOG) at pre-randomization visit, response at randomization and baseline PD-L1 status.|Log Rank||Based on Cox regression model with Efron's method of tie handling and with treatment as a covariate stratified by ECOG at pre-randomization visit, response at randomization and baseline PD-L1 status.|||1.36|0.92|0.8721
72457300|NCT03976323|144437181|SUPERIORITY||Hazard Ratio (HR)|1.04||||0.6649|TWO_SIDED|95.0|0.87|1.25||One-sided p-value based on log-rank test stratified by ECOG at pre-randomization visit, response at randomization and baseline PD-L1 status.|Log Rank||Based on Cox regression model with Efron's method of tie handling and with treatment as a covariate stratified by ECOG at pre-randomization visit, response at randomization and baseline PD-L1 status.|||1.25|0.87|0.6649
72457301|NCT03976323|144437184|SUPERIORITY||Difference in Least Squares (LS) Means|-1.9||||0.2533|TWO_SIDED|95.0|-5.16|1.36||Two-sided p-value based on t test.|t-test, 2 sided||Based on constrained longitudinal data analysis model (cLDA) model with PRO scores as response variable with covariates for treatment by time interaction, stratification factors, response at randomization and baseline PD-L1 expression as covariates.|||1.36|-5.16|0.2533
72457302|NCT03976323|144437185|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.8125|TWO_SIDED|95.0|0.76|1.24||Two-sided p-value based on log-rank test stratified by ECOG at pre-randomization visit, response at randomization, and baseline PD-L1 expression.|Log Rank||Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG at pre-randomization visit, response at randomization, and baseline PD-L1 expression.|||1.24|0.76|0.8125
72457303|NCT03976323|144437186|SUPERIORITY||Difference in LS Means|-0.16||||0.9364|TWO_SIDED|95.0|-4.02|3.71||Two-sided p-value based on t test.|t-test, 2 sided||Based on cLDA model with the PRO scores as the response variable with covariates for treatment by time interaction, stratification factors, response at randomization, and baseline PD-L1 expression as covariates.|||3.71|-4.02|0.9364
72457304|NCT03976323|144437187|SUPERIORITY||Hazard Ratio (HR)|0.88||||0.3782|TWO_SIDED|95.0|0.66|1.17||Two-sided p-value based on log-rank test stratified by ECOG at pre-randomization visit, response at randomization, and baseline PD-L1 expression.|Log Rank||Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG at pre-randomization visit, response at randomization, and baseline PD-L1 expression.|||1.17|0.66|0.3782
72457305|NCT03976323|144437188|SUPERIORITY||Difference in LS Means|-0.35||||0.8285|TWO_SIDED|95.0|-3.54|2.83||Two-sided p-value based on t test.|t-test, 2 sided||Based on cLDA model with the PRO scores as the response variable with covariates for treatment by time interaction, stratification factors, response at randomization, and baseline PD-L1 expression as covariates.|||2.83|-3.54|0.8285
72457306|NCT03976323|144437189|SUPERIORITY||Hazard Ratio (HR)|1.08||||0.6272|TWO_SIDED|95.0|0.78|1.51||Two-sided p-value based on log-rank test stratified by ECOG at pre-randomization visit, response at randomization, and baseline PD-L1 expression.|Log Rank||Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG at pre-randomization visit, response at randomization, and baseline PD-L1 expression.|||1.51|0.78|0.6272
72457307|NCT03976323|144437190|SUPERIORITY||Difference in LS Means|-1.51||||0.4422|TWO_SIDED|95.0|-5.38|2.35||Two-sided p-value based on t test.|t-test, 2 sided||Based on cLDA model with the PRO scores as the response variable with covariates for treatment by time interaction, stratification factors, response at randomization, and baseline PD-L1 expression as covariates.|||2.35|-5.38|0.4422
72457308|NCT03976323|144437191|SUPERIORITY||Hazard Ratio (HR)|0.98||||0.9156|TWO_SIDED|95.0|0.74|1.31||Two-sided p-value based on log-rank test stratified by ECOG at pre-randomization visit, response at randomization, and baseline PD-L1 expression.|Log Rank||Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG at pre-randomization visit, response at randomization, and baseline PD-L1 expression.|||1.31|0.74|0.9156
72457309|NCT03976323|144437192|SUPERIORITY||Difference in LS Means|-0.01||||0.9962|TWO_SIDED|95.0|-2.94|2.93||Two-sided p-value based on t test.|t-test, 2 sided||Based on cLDA model with the PRO scores as the response variable with covariates for treatment by time interaction, stratification factors, response at randomization, and baseline PD-L1 expression as covariates.|||2.93|-2.94|0.9962
72457310|NCT03976323|144437193|SUPERIORITY||Hazard Ratio (HR)|1.08||||0.5517|TWO_SIDED|95.0|0.83|1.4||Two-sided p-value based on log-rank test stratified by ECOG at pre-randomization visit, response at randomization, and baseline PD-L1 expression.|Log Rank||Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG at pre-randomization visit, response at randomization, and baseline PD-L1 expression.|||1.40|0.83|0.5517
72457311|NCT00535626|144437202|OTHER|"To test if revision rate at 5 years is less than 10% (Ha - Alternative Hypothesis).~Note: All cases enrolled in the study had to undergo revision whether from their primary procedure or a previous revision. Based on literature, 10% is the expected rate of another revision occurring in this cohort of enrolled patients."|Revision or Pending Revision Rate|2.43|||||TWO_SIDED|90.0|1.07|5.46|||||The estimated 2.43% revision rate was obtained by the Kaplan-Meier method.|||5.46|1.07|
72457312|NCT00535626|144437203|OTHER|To test if the change from the pre-operative HHS compared to the post-operative HHS at all intervals is statistically significant.|||||<|0.0001||||||This p-value applies to all intervals.|t-test, 2 sided|Paired t-test||||||<0.0001
72457313|NCT00535626|144437204|OTHER|To test whether the change from the pre-operative SF-36 Physical Score compared to each post-operative SF-36 Physical score is statistically significant.|||||<|0.0001||||||This p-value applies to all intervals.|t-test, 2 sided|Paired t-test||||||<0.0001
72457314|NCT00535626|144437204|OTHER|To test whether the change from the pre-operative SF-36 Mental Score compared to the 3 month SF-36 Mental Score is statistically significant.||||||0.0139|||||||t-test, 2 sided|Paired t-test||||||0.0139
72457315|NCT00535626|144437204|OTHER|To test whether the change from the pre-operative SF-36 Mental Score compared to the 1 year SF-36 Mental Score is statistically significant.||||||0.0254|||||||t-test, 2 sided|Paired t-test||||||0.0254
72457316|NCT00535626|144437204|OTHER|To test whether the change from the SF-36 Mental Score compared to the 2 year SF-36 Mental Score is statistically significant.||||||0.1506|||||||t-test, 2 sided|Paired t-test||||||0.1506
72457317|NCT00535626|144437204|OTHER|To test whether the change from the pre-operative SF-36 Mental Score compared to the 3 year SF-36 Mental Score is statistically significant.||||||0.0936|||||||t-test, 2 sided|Paired t-test||||||0.0936
72620813|NCT01887600|144772749|SUPERIORITY||Least squares mean difference|1.127|||=|0.093|TWO_SIDED|95.0|-0.19|2.44||LSM Difference p-value is for test of differences.Tested using a fixed sequence testing procedure to maintain the overall two-sided type I error rate at 0.05.|Mixed Models Analysis|||A Mixed Model of Repeated Measures has been applied using the visits up to week 28. The results were based on the estimated difference between the two treatment arms and overall mean effects throughout the evaluation period (weeks 12 to 28). The model included treatment arm, region, CV history, visits and visit by treatment as categorical variables and baseline SF-36 VT, baseline Hb and baseline eGFR as continuous variables.||2.44|-0.19|=0.093
72457318|NCT00535626|144437204|OTHER|To test if the change from the pre-operative SF-36 Mental Score compared to the 4 year SF-36 Mental Score is statistically significant.||||||0.0909|||||||t-test, 2 sided|Paired t-test||||||0.0909
72457319|NCT00535626|144437204|OTHER|To test whether the change from the pre-operative SF-36 Mental Score compared to the 5 year SF-36 Mental Score is statistically significant.||||||0.048|||||||t-test, 2 sided|Paired t-test||||||0.048
72457320|NCT00535626|144437207|OTHER|To test whether the change from the pre-operative LEAS Score compared to the 3 month LEAS Score is statistically significant.||||||0.0011|||||||t-test, 2 sided|Paired t-test||||||0.0011
72457321|NCT00535626|144437207|OTHER|To test whether the change from the pre-operative LEAS compared to the 1, 2 and 3 year LEAS are statistically significant.|||||<|0.0001||||||This p-value applies to pre-op to 1, 2 and 3 year intervals.|t-test, 2 sided|Paired t-test||||||<0.0001
72457322|NCT00535626|144437207|OTHER|To test whether the change from the pre-operative LEAS compared to the 4 year LEAS is statistically significant.||||||0.0002|||||||t-test, 2 sided|Paired t-test||||||0.0002
72457323|NCT00535626|144437207|OTHER|To test whether the change from the pre-operative LEAS compared to the 5 year LEAS is statistically significant.||||||0.0009|||||||t-test, 2 sided|Paired t-test||||||0.0009
72457324|NCT00731692|144437229|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.95||||0.544|TWO_SIDED|95.0|0.8|1.12|||Regression, Cox|||||1.12|0.80|0.544
72457325|NCT00108355|144437266|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Log Rank|||Initial estimation: median time to recurrence of ascites of 38 days in the study group and 20 days in the control group in a fixed duration of 6 months (5% type-I error (2 sided) and an 80% power). However, due to low accrual and based on randomized trials using vasoconstrictors in the prevention of PCD and a study that showed that midodrine leads to a significant improvement in effective arterial blood volume, each of which had sample sizes of 24-25 patients,we decided on a sample size of 30.||||<0.05
72457326|NCT01377844|144437278|SUPERIORITY||Difference of LS Means|-0.79|||<|0.0001|TWO_SIDED|95.0|-1.06|-0.53||The p-value is from a 2-sided t-test for the difference in means of change from baseline. Statistical significant is set at 0.05 level.|ANCOVA|Based on analysis of covariance, including treatment group, baseline HbA1c, site, age category, gender and race||||-0.53|-1.06|< 0.0001
72457327|NCT01377844|144437279|SUPERIORITY||Difference of LS Means|-5.53|||<|0.0001|TWO_SIDED|95.0|-8.02|-3.04||The p-value is from a 2-sided t-test for the difference in means of change from baseline. Statistical significant is set at 0.05 level.|ANCOVA|Based on analysis of covariance, including treatment group, baseline systolic BP, baseline HbA1c category, site, age category, gender and race||||-3.04|-8.02|< 0.0001
72457328|NCT01377844|144437279|SUPERIORITY||Difference of LS Means|-2.67||||0.0015|TWO_SIDED|95.0|-4.3|-1.04||The p-value is from a 2-sided t-test for the difference in means of change from baseline. Statistical significant is set at 0.05 level.|ANCOVA|Based on analysis of covariance, including treatment group, baseline diastolic BP, baseline HbA1c category, site, age category, gender and race||||-1.04|-4.30|0.0015
72457329|NCT01377844|144437280|SUPERIORITY||Difference of LS Means|-1.72|||<|0.0001|TWO_SIDED|95.0|-2.52|-0.93||The p-value is from a 2-sided t-test for the difference in means of change from baseline. Statistical significant is set at 0.05 level.|ANCOVA|Based on analysis of covariance, including treatment group, baseline weight, baseline HbA1c category, site, age category, gender and race||||-0.93|-2.52|< 0.0001
72457330|NCT01377844|144437281|SUPERIORITY||Difference of LS Means|-0.32|||<|0.0001|TWO_SIDED|95.0|-0.42|-0.21||The p-value is from a 2-sided t-test for the difference in means of change from baseline. Statistical significant is set at 0.05 level.|ANCOVA|Based on analysis of covariance, including treatment group, baseline HbA1c, site, age category, gender and race||Change from baseline in HbA1c (%) at Week 2||-0.21|-0.42|< 0.0001
72457331|NCT01377844|144437281|SUPERIORITY||Difference of LS Means|-0.59|||<|0.0001|TWO_SIDED|95.0|-0.78|-0.41||The p-value is from a 2-sided t-test for the difference in means of change from baseline. Statistical significant is set at 0.05 level.|ANCOVA|Based on analysis of covariance, including treatment group, baseline HbA1c, site, age category, gender and race||Change from baseline in HbA1c (%) at Week 6||-0.41|-0.78|< 0.0001
72457332|NCT01377844|144437281|SUPERIORITY||Difference of LS Means|-0.72|||<|0.0001|TWO_SIDED|95.0|-0.96|-0.48||The p-value is from a 2-sided t-test for the difference in means of change from baseline. Statistical significant is set at 0.05 level.|ANCOVA|Based on analysis of covariance, including treatment group, baseline HbA1c, site, age category, gender and race||Change from baseline in HbA1c (%) at Week 12||-0.48|-0.96|< 0.0001
72457333|NCT01377844|144437281|SUPERIORITY||Difference of LS Means|-0.71|||<|0.0001|TWO_SIDED|95.0|-0.97|-0.44||The p-value is from a 2-sided t-test for the difference in means of change from baseline. Statistical significant is set at 0.05 level.|ANCOVA|Based on analysis of covariance, including treatment group, baseline HbA1c, site, age category, gender and race||Change from baseline in HbA1c (%) at Week 18||-0.44|-0.97|< 0.0001
72457334|NCT01377844|144437281|SUPERIORITY||Difference of LS Means|-0.79|||<|0.0001|TWO_SIDED|95.0|-1.06|-0.53||The p-value is from a 2-sided t-test for the difference in means of change from baseline. Statistical significant is set at 0.05 level.|ANCOVA|Based on analysis of covariance, including treatment group, baseline HbA1c, site, age category, gender and race||Change from baseline in HbA1c (%) at Week 24||-0.53|-1.06|< 0.0001
72457335|NCT01377844|144437281|SUPERIORITY||Difference of LS Means|-0.93|||<|0.0001|TWO_SIDED|95.0|-1.21|-0.66||The p-value is from a 2-sided t-test for the difference in means of change from baseline. Statistical significant is set at 0.05 level.|ANCOVA|Based on analysis of covariance, including treatment group, baseline HbA1c, site, age category, gender and race||Change from baseline in HbA1c (%) at Week 36||-0.66|-1.21|< 0.0001
72500260|NCT01552057|144530931|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.76||||0.0003|TWO_SIDED|95.0|3.57|11.94||Statistical tests were conducted at a 2-sided alpha level of 0.05.|ANCOVA|||Role-Physical||11.94|3.57|0.0003
72457336|NCT01377844|144437281|SUPERIORITY||Difference of LS Means|-0.99|||<|0.0001|TWO_SIDED|95.0|-1.28|-0.7||The p-value is from a 2-sided t-test for the difference in means of change from baseline. Statistical significant is set at 0.05 level|ANCOVA|Based on analysis of covariance, including treatment group, baseline HbA1c, site, age category, gender and race||Change from baseline in HbA1c (%) at Week 48||-0.70|-1.28|< 0.0001
72500261|NCT01552057|144530931|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.67||||0.0002|TWO_SIDED|95.0|2.76|8.59||Statistical tests were conducted at a 2-sided alpha level of 0.05.|ANCOVA|||Bodily Pain||8.59|2.76|0.0002
72500262|NCT01552057|144530931|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.25||||0.0192|TWO_SIDED|95.0|0.53|5.96||Statistical tests were conducted at a 2-sided alpha level of 0.05.|ANCOVA|||General Health||5.96|0.53|0.0192
72457337|NCT01377844|144437281|SUPERIORITY||Difference of LS Means|-0.98|||<|0.0001|TWO_SIDED|95.0|-1.27|-0.68||The p-value is from a 2-sided t-test for the difference in means of change from baseline. Statistical significant is set at 0.05 level|ANCOVA|Based on analysis of covariance, including treatment group, baseline HbA1c, site, age category, gender and race||Change from baseline in HbA1c (%) at Week 60||-0.68|-1.27|< 0.0001
72457338|NCT01377844|144437281|SUPERIORITY||Difference of LS Means|-0.93|||<|0.0001|TWO_SIDED|95.0|-1.22|-0.64||The p-value is from a 2-sided t-test for the difference in means of change from baseline. Statistical significant is set at 0.05 level|ANCOVA|Based on analysis of covariance, including treatment group, baseline HbA1c, site, age category, gender and race||Change from baseline in HbA1c (%) at Week 72||-0.64|-1.22|< 0.0001
72457339|NCT01377844|144437281|SUPERIORITY||Difference of LS Means|-0.98|||<|0.0001|TWO_SIDED|95.0|-1.27|-0.69||The p-value is from a 2-sided t-test for the difference in means of change from baseline. Statistical significant is set at 0.05 level.|ANCOVA|Based on analysis of covariance, including treatment group, baseline HbA1c, site, age category, gender and race||Change from baseline in HbA1c (%) at Week 84||-0.69|-1.27|< 0.0001
72457340|NCT01377844|144437281|SUPERIORITY||Difference of LS Means|-1.02|||<|0.0001|TWO_SIDED|95.0|-1.31|-0.73||The p-value is from a 2-sided t-test for the difference in means of change from baseline. Statistical significant is set at 0.05 level.|ANCOVA|Based on analysis of covariance, including treatment group, baseline HbA1c, site, age category, gender and race||Change from baseline in HbA1c (%) at Week 96||-0.73|-1.31|< 0.0001
72457341|NCT01377844|144437282|SUPERIORITY||Difference of LS Means|-2.24|||<|0.0001|TWO_SIDED|95.0|-2.79|-1.7||The p-value is from a two-sided t-test for the difference in means of change from baseline|ANCOVA|Based on analysis of covariance, including treatment group, baseline FPG, baseline HbA1c category, site, age category, gender and race||Difference of mean-adjusted change from baseline in FPG (mmol/L) at Week 2, between EGT0001442 and Placebo group.||-1.70|-2.79|< 0.0001
72457342|NCT01377844|144437282|SUPERIORITY||Difference of LS Means|-2.45|||<|0.0001|TWO_SIDED|95.0|-3.09|-1.81||The p-value is from a two-sided t-test for the difference in means of change from baseline|ANCOVA|Based on analysis of covariance, including treatment group, baseline FPG, baseline HbA1c category, site, age category, gender and race||Difference of mean-adjusted change from baseline in FPG (mmol/L) at Week 6, between EGT0001442 and Placebo group.||-1.81|-3.09|< 0.0001
72500263|NCT01552057|144530931|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.7||||0.0002|TWO_SIDED|95.0|3.15|10.25||Statistical tests were conducted at a 2-sided alpha level of 0.05.|ANCOVA|||Vitality||10.25|3.15|0.0002
72500264|NCT01552057|144530931|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.04||||0.0014|TWO_SIDED|95.0|2.74|11.34||Statistical tests were conducted at a 2-sided alpha level of 0.05.|ANCOVA|||Social Functioning||11.34|2.74|0.0014
72500265|NCT01552057|144530931|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.12||||0.0002|TWO_SIDED|95.0|4.41|13.83||Statistical tests were conducted at a 2-sided alpha level of 0.05.|ANCOVA|||Role-Emotional||13.83|4.41|0.0002
72457343|NCT01377844|144437282|SUPERIORITY||Difference of LS Means|-2.42|||<|0.0001|TWO_SIDED|95.0|-3.06|-1.77||The p-value is from a two-sided t-test for the difference in means of change from baseline|ANCOVA|Based on analysis of covariance, including treatment group, baseline FPG, baseline HbA1c category, site, age category, gender and race||Difference of mean-adjusted change from baseline in FPG (mmol/L) at Week 12, between EGT0001442 and Placebo group.||-1.77|-3.06|< 0.0001
72457344|NCT01377844|144437282|SUPERIORITY||Difference of LS Means|-2.71|||<|0.0001|TWO_SIDED|95.0|-3.3|-2.11||The p-value is from a two-sided t-test for the difference in means of change from baseline.|ANCOVA|Based on analysis of covariance, including treatment group, baseline FPG, baseline HbA1c category, site, age category, gender and race||Difference of mean-adjusted change from baseline in FPG (mmol/L) at Week 18, between EGT0001442 and Placebo group.||-2.11|-3.30|< 0.0001
72457345|NCT01377844|144437282|SUPERIORITY||Difference of LS Means|-2.63|||<|0.0001|TWO_SIDED|95.0|-3.24|-2.02||The p-value is from a two-sided t-test for the difference in means of change from baseline.|ANCOVA|Based on analysis of covariance, including treatment group, baseline FPG, baseline HbA1c category, site, age category, gender and race||Difference of mean-adjusted change from baseline in FPG (mmol/L) at Week 24, between EGT0001442 and Placebo group.||-2.02|-3.24|< 0.0001
72457346|NCT01928732|144437284|SUPERIORITY||Odds Ratio (OR)|1.32|||||TWO_SIDED|95.0|1.0|1.65|||||Odds ratios were calculated with CPT as the reference group and reflect the overall main effect of treatment across all outcome assessments (post-treatment, 3-months, and 6-months)|Overall Treatment Effect Response Odds Ratio (OR). Response is defined as greater than or equal to 10 point improvement in severity.||1.65|1.00|
72500266|NCT01552057|144530931|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.91|||<|0.0001|TWO_SIDED|95.0|4.39|11.43||Statistical tests were conducted at a 2-sided alpha level of 0.05.|ANCOVA|||Mental Health||11.43|4.39|<0.0001
72500267|NCT01552057|144530932|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.85||||0.0002|TWO_SIDED|95.0|-4.32|-1.38||Statistical tests were conducted at a 2-sided alpha level of 0.05.|MMRM|||||-1.38|-4.32|0.0002
72500268|NCT01552057|144530933|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.28||||0.0029|TWO_SIDED|95.0|-2.12|-0.44||Statistical tests were conducted at a 2-sided alpha level of 0.05.|MMRM|||WPI||-0.44|-2.12|0.0029
72500269|NCT01552057|144530933|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.36||||0.0906|TWO_SIDED|95.0|-0.79|0.06||Statistical tests were conducted at a 2-sided alpha level of 0.05.|MMRM|||Symptom Severity||0.06|-0.79|0.0906
72500270|NCT01552057|144530934|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.33||||0.0755|TWO_SIDED|95.0|-0.7|0.03||Statistical tests were conducted at a 2-sided alpha level of 0.05.|MMRM|||Average Pain||0.03|-0.70|0.0755
72457347|NCT01928732|144437284|SUPERIORITY||Odds Ratio (OR)|1.43|||||TWO_SIDED|95.0|1.12|1.74|||||Odds ratios were calculated with CPT as the reference group and reflect the overall main effect of treatment across all outcome assessments (post-treatment, 3-months, and 6-months)|Overall Treatment Effect Loss of Diagnosis Odds Ratio (OR). Loss of Diagnosis is defined as Response, plus no longer meeting DSM-5 symptom criteria and severity less than 25.||1.74|1.12|
72457348|NCT01928732|144437284|SUPERIORITY||Odds Ratio (OR)|1.62|||||TWO_SIDED|95.0|1.24|2.0|||||Odds ratios were calculated with CPT as the reference group and reflect the overall main effect of treatment across all outcome assessments (post-treatment, 3-months, and 6-months)|Overall Treatment Effect Remission Odds Ratio (OR). Remission is defined as loss of diagnosis plus severity less than 12.||2.00|1.24|
72457349|NCT01185340|144437292|SUPERIORITY_OR_OTHER|||||||0.751|||||||Mixed Models Analysis|||||||0.751
72457350|NCT00087516|144437311|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.79|STANDARD_ERROR_OF_MEAN|0.09|<|0.001||95.0|-0.96|-0.62|||ANCOVA|Model terms: treatment, presence/absence of prior diabetes pharmacotherapy, baseline A1C||||-0.62|-0.96|<0.001
72457351|NCT00087516|144437311|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.94|STANDARD_ERROR_OF_MEAN|0.09|<|0.001||95.0|-1.11|-0.77|||ANCOVA|Model terms: treatment, presence/absence of prior diabetes pharmacotherapy, baseline A1C||||-0.77|-1.11|<0.001
72500271|NCT01552057|144530934|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.47||||0.0232|TWO_SIDED|95.0|-0.88|-0.06||Statistical tests were conducted at a 2-sided alpha level of 0.05.|MMRM|||Worst Pain||-0.06|-0.88|0.0232
72500272|NCT01552057|144530935|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.56||||0.0126|TWO_SIDED|95.0|-0.99|-0.12||Statistical tests were conducted at a 2-sided alpha level of 0.05.|MMRM|||Worst Pain||-0.12|-0.99|0.0126
72620814|NCT01887600|144772750|SUPERIORITY||Least squares mean difference|0.713|||=|0.27|TWO_SIDED|95.0|-0.56|1.98||LSM Difference p-value is for test of differences. Tested using a fixed sequence testing procedure to maintain the overall two-sided type I error rate at 0.05.|Mixed Models Analysis|||A Mixed Model of Repeated Measures has been applied using the visits up to week 28. The results were based on the estimated difference between the two treatment arms and overall mean effects throughout the evaluation period (weeks 12 to 28). The model included treatment arm, region, CV history, visits and visit by treatment as categorical variables and baseline SF-36 PF, baseline Hb and baseline eGFR as continuous variables.||1.98|-0.56|=0.27
72620815|NCT01887600|144772751|NON_INFERIORITY|Non-inferiority can be concluded if the upper bound of the two-sided 95% CI of the difference between roxadustat and placebo (roxadustat minus placebo) is below 2 mmHg.|Least squares mean difference|0.842|||=|0.182|TWO_SIDED|95.0|-0.4|2.08||LSM Difference p-value is for test of differences.|Mixed Models Analysis|||Mixed Model of Repeated Measures was applied using the visits up to week 28. The results were based on the estimated difference between the two treatment arms with overall mean effects throughout the evaluation period (weeks 20 to 28). The model included treatment, visit, visit by treatment interaction, region and history of CV disease as fixed class factors and baseline MAP, baseline Hb, baseline eGFR as continuous covariates.||2.08|-0.40|=0.182
72620816|NCT01887600|144772752|NON_INFERIORITY|Non-inferiority is declared if the upper bound of the 95% CI is below 1.3 (hazard ratio).|Hazard Ratio (HR)|1.29|||=|0.334|TWO_SIDED|95.0|0.77|2.16|||Regression, Cox|||Hazard ratio was calculated using stratified Cox Proportional Hazards Regression stratifying on CV history and region and adjusting on Hb and eGFR at baseline as continuous covariates.||2.16|0.77|=0.334
72620817|NCT01887600|144772753|SUPERIORITY||Least squares mean difference|0.59|||=|0.316|TWO_SIDED|95.0|-0.57|1.75|||Mixed Models Analysis|||Annualized eGFR slope over time was estimated by a random slopes and intercepts model using all available eGFR values adjusted on baseline Hb, region, CV history at Baseline and the interaction terms.||1.75|-0.57|=0.316
72457352|NCT00087516|144437312|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-17.1|STANDARD_ERROR_OF_MEAN|3.6|<|0.001||95.0|-24.1|-10.1|||ANCOVA|Model terms: treatment, presence/absence of prior diabetes pharmacotherapy, baseline FPG||||-10.1|-24.1|<0.001
72457353|NCT00087516|144437312|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-21.3|STANDARD_ERROR_OF_MEAN|3.5|<|0.001||95.0|-28.2|-14.4|||ANCOVA|Model terms: treatment, presence/absence of prior diabetes pharmacotherapy, baseline FPG||||-14.4|-28.2|<0.001
72457354|NCT00087516|144437313|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-46.7|STANDARD_ERROR_OF_MEAN|6.5|<|0.001||95.0|-59.4|-34.1|||ANCOVA|Model terms: treatment, presence/absence of prior diabetes pharmacotherapy, baseline 2-hr PMG||||-34.1|-59.4|<0.001
72457355|NCT00087516|144437313|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-54.1|STANDARD_ERROR_OF_MEAN|6.4|<|0.001||95.0|-66.7|-41.6|||ANCOVA|Model terms: treatment, presence/absence of prior diabetes pharmacotherapy, baseline 2-hr PMG||||-41.6|-66.7|<0.001
72457356|NCT02065895|144437317|OTHER|ANOVA was used to first tests the hypothesis that there is a difference among the three groups.|Mean Difference (Final Values)|66.8||||0.0011|TWO_SIDED|95.0|33.4|80.3||The p value was adjusted for multiple comparisons using Sidak's correction. A priori the pimary outcome was defined as blood glucose AUC from 8 am - 12pm; however we used blood glucose AUC from 8am - 2pm to capture the entire meal response.|ANOVA|||Differences among the 3 groups were assessed by repeated measures ANOVA using Sidak's correction for multiple comparisons. All subjects were analyzed as a single group, no comparison group.||80.3|33.4|0.0011
72457357|NCT02065895|144437318|OTHER|||||||0.0059|||||||ANOVA|||||||0.0059
72457358|NCT01093690|144437320|SUPERIORITY_OR_OTHER|||||||0.41||||||No adjustment.|Chi-squared|1-sided test||the study had 80 percent power to detect an absolute difference of 20 percent in complete response (70% for metoclopramide group vs 50% for control group)||||0.41
72457359|NCT00569166|144437337|SUPERIORITY_OR_OTHER|||||||0.3679||95.0|||||Wilcoxon rank-sum|||Treatment effectiveness was measured using pairwise comparisons of hot flash score change from baseline in each paced breathing arm.||||0.3679
72457360|NCT00569166|144437337|SUPERIORITY_OR_OTHER|||||||0.4715||95.0|||||Wilcoxon rank-sum|||Treatment effectiveness was measured using pairwise comparisons of hot flash score change from baseline in each paced breathing arm.||||0.4715
72500273|NCT01552057|144530935|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.49||||0.0092|TWO_SIDED|95.0|-0.87|-0.12||Statistical tests were conducted at a 2-sided alpha level of 0.05.|MMRM|||Least Pain||-0.12|-0.87|0.0092
72457361|NCT01686152|144437368|EQUIVALENCE|The test product was determined to be bioequivalent to the reference product if the 90% confidence interval was within -0.20 to 0.20.|Mean Difference (Final Values)|0.05|||||TWO_SIDED|90.0|-0.0663|0.0913||||||||0.0913|-0.0663|
72457362|NCT00704340|144437377|SUPERIORITY_OR_OTHER|||||||0.613|||||||t-test, 2 sided|||The sample size was selected to provide sufficient precision for 95% confidence intervals for the incidence of neurosurgical complications in each arm. The sample size was selected so that the half-width of the normal approximation-based intervals would be no more than 0.05 percentage points. This requires a sample size of 114 evaluable patients in each arm. To allow for loss to follow-up, the sample size was increased to 125 randomized patients in each treatment arm, or a total of 250 patients.||||.613
72457363|NCT00704340|144437378|SUPERIORITY_OR_OTHER|||||||0.681|||||||t-test, 2 sided|||||||.681
72457364|NCT00704340|144437379|SUPERIORITY_OR_OTHER|||||||0.619|||||||t-test, 2 sided|||||||.619
72457365|NCT00321971|144437408|SUPERIORITY||Mean Difference (Final Values)|0.421|STANDARD_ERROR_OF_MEAN|0.11|<|0.05|TWO_SIDED|95.0|0.208|0.657|||Mixed Models Analysis|Intention-to-treat model|The CES-D data were log-transformed for analysis|Hypothesis: The experimental intervention group will endorse lower mean levels of depressive symptoms during follow-up than the study group receiving the comparison intervention.||0.657|0.208|<.05
72457366|NCT01393600|144437419|OTHER||Mean Difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|1.3||0.588|TWO_SIDED|95.0|-3.3|1.9|||ANOVA|||||1.9|-3.3|0.5880
72457367|NCT01393600|144437419|OTHER||Mean Difference (Final Values)|-1.1|STANDARD_ERROR_OF_MEAN|1.3||0.4184|TWO_SIDED|95.0|-3.8|1.6|||ANOVA|||||1.6|-3.8|0.4184
72457368|NCT01393600|144437421|OTHER||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|1.0||0.6761|TWO_SIDED|95.0|-2.4|1.6|||ANOVA|||||1.6|-2.4|0.6761
72457369|NCT01393600|144437421|OTHER||Mean Difference (Final Values)|-4.2|STANDARD_ERROR_OF_MEAN|1.1||0.0015|TWO_SIDED|95.0|-6.6|-1.8|||ANOVA|||||-1.8|-6.6|0.0015
72457370|NCT01918033|144437440|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares (LS) Means|-0.09||||0.661|TWO_SIDED|95.0|-0.49|0.31|||Constrained Longitudinal Data Analysis|Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable|Difference in LS Means for Change from Baseline in TNSS at Week 2|||0.31|-0.49|0.661
72457371|NCT01918033|144437440|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.08||||0.707|TWO_SIDED|95.0|-0.48|0.32|||Constrained Longitudinal Data Analysis|Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable|Difference in LS Means for Change from Baseline in TNSS at Week 2|||0.32|-0.48|0.707
72457372|NCT01918033|144437443|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.48||||0.01|TWO_SIDED|95.0|-0.84|-0.11|||Constrained Longitudinal Data Analysis|Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable|Difference in LS Means for Change from Baseline in TNSS at Day 3|||-0.11|-0.84|0.010
72457373|NCT01918033|144437443|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.46||||0.013|TWO_SIDED|95.0|-0.82|-0.1|||Constrained Longitudinal Data Analysis|Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable|Difference in LS Means for Change from Baseline in TNSS at Day 3|||-0.10|-0.82|0.013
72457374|NCT01918033|144437443|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|0.12||||0.569|TWO_SIDED|95.0|-0.29|0.53|||Constrained Longitudinal Data Analysis|Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable|Difference in LS Means for Change from Baseline in TNSS at Week 1|||0.53|-0.29|0.569
72457375|NCT01918033|144437443|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|0.09||||0.685|TWO_SIDED|95.0|-0.33|0.5|||Constrained Longitudinal Data Analysis|Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable|Difference in LS Means for Change from Baseline in TNSS at Week 1|||0.50|-0.33|0.685
72500274|NCT01552057|144530935|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.57||||0.0083|TWO_SIDED|95.0|-1.0|-0.15||Statistical tests were conducted at a 2-sided alpha level of 0.05.|MMRM|||Pain Right Now||-0.15|-1.00|0.0083
72457376|NCT01918033|144437444|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.03||||0.547|TWO_SIDED|95.0|-0.15|0.08|||Constrained Longitudinal Data Analysis|Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable|Difference in LS Means for Change From Baseline in Sneezing Nasal Symptom Sub-Score at Week 2|||0.08|-0.15|0.547
72457377|NCT01918033|144437444|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.1||||0.067|TWO_SIDED|95.0|-0.22|0.01|||Constrained Longitudinal Data Analysis|Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable|Difference in LS Means for Change From Baseline in Sneezing Nasal Symptom Sub-Score at Week 2|||0.01|-0.22|0.067
72457378|NCT01918033|144437444|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.01||||0.895|TWO_SIDED|95.0|-0.15|0.13|||Constrained Longitudinal Data Analysis|Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable|Difference in LS Means for Change From Baseline in Rhinorrhea Nasal Symptom Sub-Score at Week 2|||0.13|-0.15|0.895
72500275|NCT01552057|144530935|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.46||||0.0807|TWO_SIDED|95.0|-0.98|0.06||Statistical tests were conducted at a 2-sided alpha level of 0.05.|MMRM|||Interference With General Activity||0.06|-0.98|0.0807
72457379|NCT01918033|144437444|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|0.03||||0.627|TWO_SIDED|95.0|-0.1|0.17|||Constrained Longitudinal Data Analysis|Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable|Difference in LS Means for Change From Baseline in Rhinorrhea Nasal Symptom Sub-Score at Week 2|||0.17|-0.10|0.627
72457380|NCT01918033|144437444|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|0.04||||0.535|TWO_SIDED|95.0|-0.09|0.18|||Constrained Longitudinal Data Analysis|Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable|Difference in LS Means for Change From Baseline in Nasal Congestion Nasal Symptom Sub-Score at Week 2|||0.18|-0.09|0.535
72500276|NCT01552057|144530935|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.75||||0.0057|TWO_SIDED|95.0|-1.29|-0.22||Statistical tests were conducted at a 2-sided alpha level of 0.05.|MMRM|||Interference With Mood||-0.22|-1.29|0.0057
72457381|NCT01918033|144437444|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|0.04||||0.557|TWO_SIDED|95.0|-0.1|0.18|||Constrained Longitudinal Data Analysis|Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable|Difference in LS Means for Change From Baseline in Nasal Congestion Nasal Symptom Sub-Score at Week 2|||0.18|-0.10|0.557
72457382|NCT01918033|144437444|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.11||||0.119|TWO_SIDED|95.0|-0.25|0.03|||Constrained Longitudinal Data Analysis|Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable|Difference in LS Means for Change From Baseline in Nasal Itching Nasal Symptom Sub-Score at Week 2|||0.03|-0.25|0.119
72457383|NCT01918033|144437444|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.06||||0.403|TWO_SIDED|95.0|-0.2|0.08|||Constrained Longitudinal Data Analysis|Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable|Difference in LS Means for Change From Baseline in Nasal Itching Nasal Symptom Sub-Score at Week 2|||0.08|-0.20|0.403
72457384|NCT01918033|144437445|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.06||||0.376|TWO_SIDED|95.0|-0.2|0.07|||Constrained Longitudinal Data Analysis|Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable|Difference in LS Means for Change From Baseline in Swelling of INCM at Week 2|||0.07|-0.20|0.376
72457385|NCT01918033|144437445|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.03||||0.714|TWO_SIDED|95.0|-0.16|0.11|||Constrained Longitudinal Data Analysis|Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable|Difference in LS Means for Change From Baseline in Swelling of INCM at Week 2|||0.11|-0.16|0.714
72457386|NCT01918033|144437445|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.03||||0.725|TWO_SIDED|95.0|-0.19|0.13|||Constrained Longitudinal Data Analysis|Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable|Difference in LS Means for Change From Baseline in Coloring of INCM at Week 2|||0.13|-0.19|0.725
72457387|NCT01918033|144437445|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.03||||0.708|TWO_SIDED|95.0|-0.19|0.13|||Constrained Longitudinal Data Analysis|Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable|Difference in LS Means for Change From Baseline in Coloring of INCM at Week 2|||0.13|-0.19|0.708
72457388|NCT01918033|144437445|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|0.03||||0.68|TWO_SIDED|95.0|-0.1|0.16|||Constrained Longitudinal Data Analysis|Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable|Difference in LS Means for Change From Baseline in NDP at Week 2|||0.16|-0.10|0.680
72457389|NCT01918033|144437445|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|0.06||||0.373|TWO_SIDED|95.0|-0.07|0.19|||Constrained Longitudinal Data Analysis|Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable|Difference in LS Means for Change From Baseline in NDP at Week 2|||0.19|-0.07|0.373
72457390|NCT01918033|144437446|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.01||||0.849|TWO_SIDED|95.0|-0.14|0.12|||Constrained Longitudinal Data Analysis|Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable|Difference in LS Means for Change From Baseline in Eye Symptom Score at Week 2|||0.12|-0.14|0.849
72457391|NCT01918033|144437446|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.07||||0.26|TWO_SIDED|95.0|-0.2|0.06|||Constrained Longitudinal Data Analysis|Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable|Difference in LS Means for Change From Baseline in Eye Symptom Score at Week 2|||0.06|-0.20|0.260
72457392|NCT01918033|144437447|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.826||||0.34|TWO_SIDED|95.0|0.558|1.223|||Regression, Logistic|Logistic model with global improvement rate as response variable and treatment, age strata, and severity as factors|Difference in the number of participants with moderate or remarkable improvement at Week 2. An odds ratio \>1 is in favor of the first group of the pairwise comparison.|||1.223|0.558|0.340
72457393|NCT01918033|144437447|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.755||||0.159|TWO_SIDED|95.0|0.51|1.116|||Regression, Logistic|Logistic model with global improvement rate as response variable and treatment, age strata, and severity as factors|Difference in the number of participants with moderate or remarkable improvement at Week 2. An odds ratio \>1 is in favor of the first group of the pairwise comparison.|||1.116|0.510|0.159
72457394|NCT01918033|144437448|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|0.02||||0.705|TWO_SIDED|95.0|-0.09|0.14|||Constrained Longitudinal Data Analysis|Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable|Difference in LS Means for Change from Baseline in Interference with Daily Activities at Week 2|||0.14|-0.09|0.705
72457395|NCT01918033|144437448|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.02||||0.782|TWO_SIDED|95.0|-0.13|0.1|||Constrained Longitudinal Data Analysis|Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable|Difference in LS Means for Change from Baseline in Interference with Daily Activities at Week 2|||0.10|-0.13|0.782
72457396|NCT01918033|144437449|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.1||||0.175|TWO_SIDED|95.0|-0.24|0.04|||Constrained Longitudinal Data Analysis|Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable|Difference in LS Means for Change from Baseline in Sneezing at Week 2|||0.04|-0.24|0.175
72457397|NCT01918033|144437449|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.12||||0.098|TWO_SIDED|95.0|-0.26|0.02|||Constrained Longitudinal Data Analysis|Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable|Difference in LS Means for Change from Baseline in Sneezing at Week 2|||0.02|-0.26|0.098
72457398|NCT01918033|144437449|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|0.12||||0.13|TWO_SIDED|95.0|-0.04|0.27|||Constrained Longitudinal Data Analysis|Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable|Difference in LS Means for Change from Baseline in Rhinorrhea at Week 2|||0.27|-0.04|0.130
72457399|NCT01918033|144437449|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|0.07||||0.375|TWO_SIDED|95.0|-0.08|0.22|||Constrained Longitudinal Data Analysis|Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable|Difference in LS Means for Change from Baseline in Rhinorrhea at Week 2|||0.22|-0.08|0.375
72457400|NCT01918033|144437449|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|0.08||||0.285|TWO_SIDED|95.0|-0.07|0.24|||Constrained Longitudinal Data Analysis|Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable|Difference in LS Means for Change from Baseline in Nasal Congestion at Week 2|||0.24|-0.07|0.285
72457401|NCT01918033|144437449|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|0.05||||0.49|TWO_SIDED|95.0|-0.1|0.21|||Constrained Longitudinal Data Analysis|Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable|Difference in LS Means for Change from Baseline in Nasal Congestion at Week 2|||0.21|-0.10|0.490
72457402|NCT01918033|144437449|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.08||||0.345|TWO_SIDED|95.0|-0.23|0.08|||Constrained Longitudinal Data Analysis|Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable|Difference in LS Means for Change from Baseline in Nasal Itching at Week 2|||0.08|-0.23|0.345
72457403|NCT01918033|144437449|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.03||||0.699|TWO_SIDED|95.0|-0.19|0.13|||Constrained Longitudinal Data Analysis|Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable|Difference in LS Means for Change from Baseline in Nasal Itching at Week 2|||0.13|-0.19|0.699
72457404|NCT01918033|144437450|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.06||||0.414|TWO_SIDED|95.0|-0.2|0.08|||Constrained Longitudinal Data Analysis|Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable|Difference in LS Means for Change from Baseline in Eye Symptom Score at Week 2|||0.08|-0.20|0.414
72457405|NCT01918033|144437450|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.08||||0.281|TWO_SIDED|95.0|-0.22|0.06|||Constrained Longitudinal Data Analysis|Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable|Difference in LS Means for Change from Baseline in Eye Symptom Score at Week 2|||0.06|-0.22|0.281
72457406|NCT01702259|144437454|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Fisher Exact|||||||<0.0001
72457407|NCT01702259|144437455|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||t-test, 2 sided|||||||<0.05
72457408|NCT01702259|144437456|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||t-test, 2 sided|||||||<0.01
72457409|NCT01702259|144437457|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||t-test, 2 sided|||||||<0.01
72457410|NCT03136861|144437466|SUPERIORITY||Odds Ratio (OR)|1.89||||0.0264|TWO_SIDED|95.0|1.08|3.33|||Regression, Logistic|Logistic regression model: logit (proportion) = treatment + stratification factor of prior exposure to TNF inhibitors (i.e. TNF-naïve or TNFα-IR).||Average Spinal Pain Score \<4 at Week 8||3.33|1.08|0.0264
72457411|NCT03136861|144437466|SUPERIORITY||Odds Ratio (OR)|1.72||||0.072|TWO_SIDED|95.0|0.95|3.1|||Regression, Logistic|Logistic regression model: logit (proportion) = treatment + stratification factor of prior exposure to TNF inhibitors (i.e. TNF-naïve or TNFα-IR)||Total Spinal Pain Score \<4 at Week 8||3.10|0.95|0.0720
72457412|NCT03136861|144437466|SUPERIORITY||Odds Ratio (OR)|2.38||||0.0043|TWO_SIDED|95.0|1.31|4.31|||Regression, Logistic|Logistic regression model: logit (proportion) = treatment + stratification factor of prior exposure to TNF inhibitors (i.e. TNF-naïve or TNFα-IR)||Nocturnal Spinal Pain Score||4.31|1.31|0.0043
72457413|NCT03136861|144437467|SUPERIORITY||Odds Ratio (OR)|1.75||||0.0466|TWO_SIDED|95.0|1.01|3.04|||Regression, Logistic|Logistic regression model: logit (proportion) = treatment + stratification factor of prior exposure to TNF inhibitors (i.e. TNF-naïve or TNFα-IR).||BASDAI Score \<4 at Week 8||3.04|1.01|0.0466
72457414|NCT01584648|144437468|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.73|||||TWO_SIDED|95.0|0.59|0.91|||||Hazard ratios (HRs) were estimated using a Pike estimator.|||0.91|0.59|
72457415|NCT01584648|144437469|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.81|||||TWO_SIDED|95.0|0.64|1.02|||||Hazard ratios (HRs) were estimated using a Pike estimator.|||1.02|0.64|
72457416|NCT01328756|144437493|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||t-test, 2 sided|||Change from baseline to LOTA value was assessed for differences from zero using a 2-sided, 1 sample t-test at a 0.05 significance level.||||< 0.001
72457417|NCT04492475|144437516|SUPERIORITY||Cox Proportional Hazard|0.99||||0.88|TWO_SIDED|95.0|0.87|1.13|||Log Rank|||||1.13|0.87|0.880
72457418|NCT04492475|144437533|SUPERIORITY||Risk Difference (RD)|7.2|||||TWO_SIDED|95.0|0.9|13.4||||||||13.4|0.9|
72457419|NCT04492475|144437533|SUPERIORITY||Risk Difference (RD)|23.6|||||TWO_SIDED|95.0|0.0|43.9||||||||43.9|0.0|
72457420|NCT04492475|144437534|SUPERIORITY||Risk Difference (RD)|1.4|||||TWO_SIDED|95.0|-3.2|6.0||||||||6.0|-3.2|
72457421|NCT04492475|144437534|SUPERIORITY||Risk Difference (RD)|35.8|||||TWO_SIDED|95.0|12.3|54.2||||||||54.2|12.3|
72457422|NCT04492475|144437558|SUPERIORITY||Cox Proportional Hazard|1.04|||||TWO_SIDED|95.0|0.9|1.19||||||||1.19|0.90|
72457423|NCT04492475|144437558|SUPERIORITY||Cox Proportional Hazard|0.37|||||TWO_SIDED|95.0|0.21|0.66||||||||0.66|0.21|
72457424|NCT04492475|144437559|SUPERIORITY||Cox Proportional Hazard|1.04|||||TWO_SIDED|95.0|0.91|1.19||||||||1.19|0.91|
72457425|NCT04492475|144437559|SUPERIORITY||Cox Proportional Hazard|0.44|||||TWO_SIDED|95.0|0.24|0.82||||||||0.82|0.24|
72457426|NCT04492475|144437560|SUPERIORITY||Cox Proportional Hazard|1.08|||||TWO_SIDED|95.0|0.93|1.26||||||||1.26|0.93|
72457427|NCT04492475|144437560|SUPERIORITY||Cox Proportional Hazard|0.39|||||TWO_SIDED|95.0|0.21|0.72||||||||0.72|0.21|
72457428|NCT04492475|144437561|SUPERIORITY||Cox Proportional Hazard|1.04|||||TWO_SIDED|95.0|0.9|1.19||||||||1.19|0.90|
72457429|NCT04492475|144437562|SUPERIORITY||Cox Proportional Hazard|0.92|||||TWO_SIDED|95.0|0.59|1.45||||||This analysis is for Asian participants.||1.45|0.59|
72457430|NCT04492475|144437562|SUPERIORITY||Cox Proportional Hazard|0.92|||||TWO_SIDED|95.0|0.66|1.27||||||This analysis is for Black and African American participants.||1.27|0.66|
72457431|NCT04492475|144437562|SUPERIORITY||Cox Proportional Hazard|1.02|||||TWO_SIDED|95.0|0.86|1.21||||||This analysis is for White participants.||1.21|0.86|
72457432|NCT04492475|144437562|SUPERIORITY||Cox Proportional Hazard|0.84|||||TWO_SIDED|95.0|0.59|1.19||||||This analysis is for Race of Other participants||1.19|0.59|
72457433|NCT04492475|144437563|SUPERIORITY||Cox Proportional Hazard|1.02|||||TWO_SIDED|95.0|0.86|1.19||||||This analysis is for Not Hispanic or Latino participants.||1.19|0.86|
72457434|NCT04492475|144437563|SUPERIORITY||Cox Proportional Hazard|0.83|||||TWO_SIDED|95.0|0.65|1.05||||||This analysis is for Hispanic or Latino participants.||1.05|0.65|
72457435|NCT04492475|144437564|SUPERIORITY||Cox Proportional Hazard|0.93|||||TWO_SIDED|95.0|0.78|1.1||||||This analysis is for Male participants.||1.10|0.78|
72457436|NCT04492475|144437564|SUPERIORITY||Cox Proportional Hazard|1.05|||||TWO_SIDED|95.0|0.86|1.29||||||This analysis is for Female participants.||1.29|0.86|
72457437|NCT03205488|144437570|SUPERIORITY|||||||0.3626|||||||Fisher Exact|One-sided Fisher's Exact tested the proportion of participants who met tolerability between the Nilotinib 150 group to the Placebo group.||||||0.3626
72457438|NCT03205488|144437570|SUPERIORITY|||||||0.3895|||||||Fisher Exact|One-sided Fisher's Exact tested the proportion of participants who met tolerability between the Nilotinib 300 group to the Placebo group.||||||0.3895
72457439|NCT03205488|144437571|EQUIVALENCE|H0 : p1 = p2, where p represents the proportion of SAEs for each group. HA : p1 ≠ p2||||||1|||||||Fisher Exact|Fisher's Exact test compared a proportion of participants who experienced any serious adverse event in the Nilotinib 150 group and the Placebo group.||||||1.00
72457440|NCT03205488|144437571|EQUIVALENCE|H0 : λ1 = λ2, where λ represents the rate of SAEs for each group. HA : λ1 ≠ λ2|Risk Ratio (RR)|0.4977||||0.5689|TWO_SIDED|95.0|0.0451|5.489|||Regression, Poisson|Rates of serious adverse event between the Nilotinib 150 group and the placebo were also compared using a Poisson regression model||||5.489|0.0451|0.5689
72457441|NCT03205488|144437571|EQUIVALENCE|H0 : p1 = p3, where p represents the proportion of SAEs for each group. HA : p1 ≠ p3||||||0.61|||||||Fisher Exact|Fisher's Exact test compared a proportion of participants who experienced any serious adverse event in the Nilotinib 300 group and the Placebo group.||||||0.61
72457442|NCT03205488|144437571|EQUIVALENCE|H0 : λ1 = λ3, where λ represents the rate of SAEs for each group. HA : λ1 ≠ λ3|Risk Ratio (RR)|0.5206||||0.594|TWO_SIDED|95.0|0.0472|5.7409|||Regression, Poisson|Rates of serious adverse event between the Nilotinib 300 group and the placebo were also compared using a Poisson regression model||||5.7409|0.0472|0.5940
72457443|NCT03205488|144437572|NON_INFERIORITY|The hypotheses of interest (H0: δ ≤ -9.8 (7 x 1.4) vs. HA: δ \> -9.8) where δ represents the change from baseline to 6 months using the MDS-UPDRS Part III ON in the Nilotinib 150 mg treatment group. The hypotheses of interest were evaluated based on an assessment of parameter estimates from a non-linear mixed effects model, adjusted for a participant's Levodopa Equivalent Daily Dose (LEDD) at each time point.|Slope|1.05||||0.0001|ONE_SIDED|90.0|-0.78||||Mixed Models Analysis|||The key secondary objective is to conduct a futility analysis within each treatment group which examines the observed change in the MDS-UPDRS Part III ON within the two dose groups compared to previously reported changes from the Pagan et al (2016) study (NCT02281474).|||-0.78|0.0001
72457444|NCT03205488|144437572|NON_INFERIORITY|The hypotheses of interest (H0: δ ≤ -9.8 (7 x 1.4) vs. HA: δ \> -9.8) where δ represents the change from baseline to 6 months using the MDS-UPDRS Part III ON in the Nilotinib 300 mg treatment group. The hypotheses of interest were evaluated based on an assessment of parameter estimates from a non-linear mixed effects model, adjusted for a participant's Levodopa Equivalent Daily Dose (LEDD) at each time point.|Slope|0.93||||0.0001|ONE_SIDED|90.0|-0.89||||Mixed Models Analysis|||The key secondary objective is to conduct a futility analysis within each treatment group which examines the observed change in the MDS-UPDRS Part III ON within the two dose groups compared to previously reported changes from the Pagan et al (2016) study (NCT02281474).|||-0.89|0.0001
72500277|NCT01552057|144530935|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.38||||0.1114|TWO_SIDED|95.0|-0.84|0.09||Statistical tests were conducted at a 2-sided alpha level of 0.05.|MMRM|||Interference With Walking Ability||0.09|-0.84|0.1114
72500278|NCT01552057|144530935|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.42||||0.1081|TWO_SIDED|95.0|-0.94|0.09||Statistical tests were conducted at a 2-sided alpha level of 0.05.|MMRM|||Interference With Normal Work||0.09|-0.94|0.1081
72500279|NCT01552057|144530935|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.55||||0.0264|TWO_SIDED|95.0|-1.04|-0.07||Statistical tests were conducted at a 2-sided alpha level of 0.05.|MMRM|||Interference With Relationships With Other People||-0.07|-1.04|0.0264
72500280|NCT01552057|144530935|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.24||||0.3959|TWO_SIDED|95.0|-0.81|0.32||Statistical tests were conducted at a 2-sided alpha level of 0.05.|MMRM|||Interference With Sleep||0.32|-0.81|0.3959
72500281|NCT01552057|144530935|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.66||||0.0119|TWO_SIDED|95.0|-1.18|-0.15||Statistical tests were conducted at a 2-sided alpha level of 0.05.|MMRM|||Interference With Enjoyment of Life||-0.15|-1.18|0.0119
72457445|NCT03205488|144437572|EQUIVALENCE|H0 : β1 = β 2 = β 3, where β represents the slope for each group. HA : at least one β i ≠ β j. Using the same LMM as in the key secondary analysis, a two degree of freedom test was used to test for any differences in the slopes from baseline to 1 month for the three treatment groups.||||||0.031|||||||Mixed Models Analysis|||Additional secondary objective #1 is to establish the degree of symptomatic effect of Nilotinib as measured by the change in the MDS\_UPDRS Part III ON score between baseline and 1 month.|In order to assess which group may be driving these findings, pairwise comparisons were also utilized (Nilotinib 150 vs PBO at 1 Month, Nilotinib 300 vs PBO at 1 month, Nilotinib 300 vs Nilotinib 150 at 1 month).|||0.031
72500282|NCT01552057|144530935|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.52||||0.0222|TWO_SIDED|95.0|-0.96|-0.07||Statistical tests were conducted at a 2-sided alpha level of 0.05.|MMRM|||Average Interference||-0.07|-0.96|0.0222
72500283|NCT01552057|144530936|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4||||0.0113|TWO_SIDED|95.0|-0.71|-0.09||Statistical tests were conducted at a 2-sided alpha level of 0.05.|MMRM|||||-0.09|-0.71|0.0113
72500284|NCT01552057|144530937|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.61||||0.0005|TWO_SIDED|95.0|-0.94|-0.27||Statistical tests were conducted at a 2-sided alpha level of 0.05.|MMRM|||||-0.27|-0.94|0.0005
72500285|NCT01552057|144530938|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.72|||<|0.0001|TWO_SIDED|95.0|-1.07|-0.37||Statistical tests were conducted at a 2-sided alpha level of 0.05.|MMRM|||||-0.37|-1.07|<0.0001
72500286|NCT01552057|144530939|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.44||||0.0226|TWO_SIDED|95.0|-0.82|-0.06||Statistical tests were conducted at a 2-sided alpha level of 0.05.|MMRM|||||-0.06|-0.82|0.0226
72500287|NCT01552057|144530940|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.38||||0.0408|TWO_SIDED|95.0|-0.74|-0.02||Statistical tests were conducted at a 2-sided alpha level of 0.05.|ANCOVA|||||-0.02|-0.74|0.0408
72457446|NCT03205488|144437572|EQUIVALENCE|H0 : β1 = β 2 = β 3, where β represents the slope for each group. HA : at least one β i ≠ β j. For this analysis, a separate LMM was constructed, modeling the change from final visit on study drug to the 30 and 60 day follow up visits, while adjusting for the MDS-UPDRS Part III ON scores at the final visit on study drug as well as the Levodopa Equivalent Daily Dose (LEDD) at each visit.||||||0.47|||||||Mixed Models Analysis|||Additional secondary objective #2 is to establish the degree of symptomatic effect of Nilotinib as measured by the change in the MDS\_UPDRS Part III ON score between the final visit on study drug and 30 days off study drug.||||0.47
72620818|NCT01887600|144772754|SUPERIORITY||Least squares mean difference|1.638|||<|0.001|TWO_SIDED|95.0|1.44|1.84||LSM Difference p-value is for test of differences|Mixed Models Analysis|||Average Level of Hb Over Weeks 28 to 36. A Mixed Model of Repeated Measures was applied using the visits over weeks 28 to 36. The results were based on the estimated difference between the two treatment arms by visit based on this MMRM model. The model included treatment arm, region, CV History, visits and visit by treatment as categorical variables and baseline Hb and baseline eGFR as continuous variables.||1.84|1.44|<0.001
72457447|NCT03205488|144437572|EQUIVALENCE|H0 : β1 = β 2 = β 3, where β represents the slope for each group. HA : at least one β i ≠ β j. Using the same LMM as in the key secondary analysis, a two degree of freedom test was used to test for any differences in the slopes from baseline to 6 months for the three treatment groups.||||||0.077|||||||Mixed Models Analysis|||Additional secondary objective #3 is to assess the impact of Nilotinib on the progression of PD disability as measured by the change in the MDS\_UPDRS Part III ON score between baseline and 6 months.|Pairwise comparisons were also examined for trends (Active 150 vs PBO at 6 Months, Active 300 vs PBO at 6 months).|||0.077
72457448|NCT03205488|144437572|EQUIVALENCE|H0 : β1 = β 2 = β 3, where β represents the slope for each group. HA : at least one β i ≠ β j. Using a similar LMM as in the key secondary analysis, except simplified to only include baseline, month 3 and month 6, a two degree of freedom test was used to test for any differences in the slopes from baseline to 6 months for the three treatment groups.||||||0.17|||||||Mixed Models Analysis|||Additional secondary objective #3 is to assess the impact of Nilotinib on the progression of PD disability as measured by the change in the MDS\_UPDRS Part III OFF score between baseline and 6 months.||||0.17
72457449|NCT02326220|144437596|SUPERIORITY||H-L estimate of median difference|0.75|||<|0.0001|TWO_SIDED|95.0|0.667|0.833||Threshold for significance at 0.05 level.|ANCOVA||Alirocumab 150 mg Q2W (Double Blind Period) vs. Placebo Q2W (Double Blind Period)|"Analysis was performed using the ranked analysis of covariance (ANCOVA) model with baseline frequency of the apheresis procedure (QW or Q2W) and Lp(a) levels (normal or elevated) as fixed effect and the baseline LDL-C level as a covariate. Hodges-Lehmann estimator of median difference (median of all pairwise differences; CI is Moses distribution free CI.~p-value is derived from the rank-based ANCOVA model. The model includes the baseline LDL-C value and stratification factors per IVRS."||0.833|0.667|< 0.0001
72457450|NCT02326220|144437597|SUPERIORITY||Least Square (LS) Mean Difference|-55.3|STANDARD_ERROR_OF_MEAN|3.9|<|0.0001|TWO_SIDED|95.0|-63.0|-47.5||Threshold for significance at 0.05 level.|MMRM|MMRM: Mixed-effect model with repeated measures|Alirocumab 150 mg Q2W (Double Blind Period) vs. Placebo Q2W (Double Blind Period)|A hierarchical testing procedure was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when previous endpoint was statistically significant at 0.05 level.||-47.5|-63.0|< 0.0001
72457451|NCT02326220|144437598|SUPERIORITY||H-L estimate of median difference|0.5|||<|0.0001|TWO_SIDED|95.0|0.5|1.0||Threshold for significance at 0.05 level.|ANCOVA||Alirocumab 150 mg Q2W (Double Blind Period) vs. Placebo Q2W (Double Blind Period)|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||1.000|0.500|<.0001
72457452|NCT02326220|144437599|SUPERIORITY||LS Mean Difference|-44.0|||<|0.0001|TWO_SIDED|95.0|-51.3|-36.6||Threshold for significance at 0.05 level.|MMRM||Alirocumab 150 mg Q2W (Double Blind Period) vs. Placebo Q2W (Double Blind Period)|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-36.6|-51.3|< 0.0001
72500288|NCT05127486|144530946|SUPERIORITY||Odds Ratio (OR)|1.06||||0.695|TWO_SIDED|95.0|0.81|1.38|||pseudo likelihood-based repeated measure|||||1.38|0.81|0.695
72370445|NCT00488683|144251631|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|0.45|||<|0.001||95.0||||Values from Group 1, 2 and 3 were combined for this analysis.|Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccinations and serogroup specific IgG concentration at 12 months of age for the serogroup Y||||<0.001
72457453|NCT02326220|144437600|SUPERIORITY||LS Mean Difference|-50.0|||<|0.0001|TWO_SIDED|95.0|-57.3|-42.7||Threshold for significance at 0.05 level.|MMRM||Alirocumab 150 mg Q2W (Double Blind Period) vs. Placebo Q2W (Double Blind Period)|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-42.7|-57.3|< 0.0001
72457454|NCT02326220|144437601|SUPERIORITY||LS Mean Difference|-39.4|||<|0.0001|TWO_SIDED|95.0|-45.6|-33.2||Threshold for significance at 0.05 level.|MMRM||Alirocumab 150 mg Q2W (Double Blind Period) vs. Placebo Q2W (Double Blind Period)|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-33.2|-45.6|< 0.0001
72457455|NCT02326220|144437602|SUPERIORITY||LS Mean Difference|4.2||||0.3012|TWO_SIDED|95.0|-3.9|12.3||Threshold for significance at 0.05 level.|MMRM||Alirocumab 150 mg Q2W (Double Blind Period) vs. Placebo Q2W (Double Blind Period)|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||12.3|-3.9|0.3012
72500289|NCT05127486|144530947|SUPERIORITY||Odds Ratio (OR)|1.18|||||TWO_SIDED|95.0|0.89|1.56|||pseudo likelihood-based repeated measure|||||1.56|0.89|
72500290|NCT05127486|144530948|SUPERIORITY||Odds Ratio (OR)|1.26|||||TWO_SIDED|95.0|0.89|1.79|||pseudo likelihood-based repeated measure|||||1.79|0.89|
72500291|NCT05127486|144530949|SUPERIORITY||LS Mean difference|-0.37|||||TWO_SIDED|95.0|-0.82|0.09|||Mixed Models Analysis|||||0.09|-0.82|
72500292|NCT05127486|144530950|SUPERIORITY||LS Mean difference|-0.55|||||TWO_SIDED|95.0|-1.11|0.0|||Mixed Models Analysis|||||0.00|-1.11|
72500293|NCT05127486|144530951|SUPERIORITY||LS Mean difference|-0.36|||||TWO_SIDED|95.0|-0.9|0.18|||Mixed Models Analysis|||||0.18|-0.90|
72457456|NCT00286325|144437642|SUPERIORITY_OR_OTHER||||||=|0.0156||95.0|||||Wilcoxon (Mann-Whitney)|||Wilcoxon comparing week zero antibody value in units to week 24 antibody value in units||||=0.0156
72457457|NCT00286325|144437643|SUPERIORITY_OR_OTHER||||||=|0.0078|ONE_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||Comparison of B cell number at week 0 to b cell number in participants at week 24||||=0.0078
72457458|NCT02699099|144437644|NON_INFERIORITY|Non-inferiority (1 month post-Dose 3 of SB257049) was defined as the upper limit (UL) of the 2-sided 95% confidence interval (CI) of the geometric mean concentration (GMC) ratio (RTS,S group/Coad group) for anti-CS, being below a limit of 2.|Geometric Mean Ratio|0.93|||||TWO_SIDED|95.0|0.81|1.07|||ANOVA|||Adjusted GMC ratios for anti-CS antibody: To demonstrate the non-inferiority of the antibody response to the CS antigen when SB257049 is co-administered with YF vaccine and a combined measles and rubella vaccine versus SB257049 administered alone.||1.07|0.81|
72457459|NCT02699099|144437649|NON_INFERIORITY|Non-inferiority was defined as the upper limit of the 95% confidence interval (CI) for the difference in seroconversion rate of the anti-measles antibody, being below 10% for the two groups (Control Group minus Coad Group).|Difference in percentage|2.05|||||TWO_SIDED|95.0|-1.29|5.89|||Miettinen and Nurminen method|Miettinen and Nurminen method was used to construct 95%CI for difference between groups||Difference in seroconversion rates against measles antibodies: To demonstrate the non-inferiority of the antibody response to the measles vaccine antigen when YF vaccine and a combined measles and rubella vaccine are coadministered with SB257049 versus administration without SB257049.||5.89|-1.29|
72457460|NCT02699099|144437652|NON_INFERIORITY|Non-inferiority was defined as the upper limit of the 95% confidence interval (CI) for the difference in seroconversion rates of the anti-rubella antibody, being below 10% for the two groups (Control Group minus Coad Group).|Difference in percentage|0.5|||||TWO_SIDED|95.0|-1.29|2.78|||Miettinen and Nurminen method|Miettinen and Nurminen method was used to construct 95%CI for difference between groups||"Difference in seroconversion rates against Rubella antibodies: To demonstrate the non-inferiority of the antibody response to the rubella vaccine antigen when YF vaccine and a combined measles and rubella vaccine are coadministered.~with SB257049 versus administration without SB257049."||2.78|-1.29|
72457461|NCT02699099|144437655|NON_INFERIORITY|Non-inferiority was defined as the upper limit of the 95% confidence interval (CI) for the difference in seropositivity rates of the anti-yellow fever antibody , being below 10% for the two groups (Control Group minus Coad Group).|Difference in percentage|0.55|||||TWO_SIDED|95.0|-2.3|3.65|||Miettinen and Nurminen method|Miettinen and Nurminen method was used to construct 95%CI for difference between groups||Difference in seropositivity rates against Yellow Fever antibodies: To demonstrate the non-inferiority of the antibody response to the YF vaccine antigen when YF vaccine and a combined measles and rubella vaccine are coadministered with SB257049 versus administration without SB257049.||3.65|-2.30|
72457462|NCT02699099|144437681|NON_INFERIORITY|Non-inferiority (1 month post-Dose 3 of SB257049) was defined as the upper limit (UL) of the 2-sided 95% confidence interval (CI) of the geometric mean concentration (GMC) ratio (RTS,S group/Coad group) for anti-CS, being below a limit of 2.|Geometric Mean Ratio|0.93|||||TWO_SIDED|95.0|0.81|1.07|||ANOVA|||Adjusted GMC ratios for anti-CS antibody: To demonstrate the non-inferiority of the antibody response to the CS antigen when SB257049 is co-administered with YF vaccine and a combined measles and rubella vaccine versus SB257049 administered alone.||1.07|0.81|
72457463|NCT02725372|144437685|SUPERIORITY||Mean Difference (Final Values)|1.99||||0.87|TWO_SIDED|95.0|-22.47|26.45|||Mixed Models Analysis|||||26.45|-22.47|0.87
72457464|NCT02725372|144437686|SUPERIORITY|||||||0.55|||||||Log Rank|||||||0.55
72457465|NCT02725372|144437688|SUPERIORITY||Mean Difference (Final Values)|-89.1||||0.01|TWO_SIDED|95.0|-156.0|-22.1|||ANCOVA|||||-22.1|-156.0|0.01
72457466|NCT02725372|144437689|SUPERIORITY||Mean Difference (Final Values)|-0.24||||0.47|TWO_SIDED|95.0|-0.89|0.41|||ANCOVA|||||0.41|-0.89|0.47
72457467|NCT02725372|144437690|SUPERIORITY||Odds Ratio (OR)|1.05||||0.26|TWO_SIDED|95.0|0.48|2.29|||Cochran-Mantel-Haenszel|||||2.29|0.48|0.26
72457468|NCT01213940|144437691|EQUIVALENCE|95% confidence limit from standard deviation of mean|||||<|0.05|||||||ANOVA|||one -way ANOVA was used for the analysis||||<0.05
72457469|NCT00824850|144437699|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-9.5|10.0||||||7vPnC serotype 4: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.0|-9.5|
72457470|NCT00824850|144437699|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-9.5|10.0||||||7vPnC serotype 6B: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.0|-9.5|
72457471|NCT00824850|144437699|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-9.5|10.0||||||7vPnC serotype 9V: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.0|-9.5|
72457472|NCT00824850|144437699|SUPERIORITY_OR_OTHER||difference in proportions|2.9|||||TWO_SIDED|95.0|-6.9|14.9||||||7vPnC serotype 14: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||14.9|-6.9|
72457473|NCT00824850|144437699|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-9.5|10.0||||||7vPnC serotype 18C: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.0|-9.5|
72457474|NCT00824850|144437699|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-9.4|10.3||||||7vPnC serotype 19F: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.3|-9.4|
72457475|NCT00824850|144437699|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-9.5|10.0||||||7vPnC serotype 23F: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.0|-9.5|
72457476|NCT00824850|144437699|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-9.5|10.0||||||Additional serotype 1: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.0|-9.5|
72457477|NCT00824850|144437699|SUPERIORITY_OR_OTHER||difference in proportions|-2.2|||||TWO_SIDED|95.0|-15.7|10.9||||||Additional serotype 3: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.9|-15.7|
72457478|NCT00824850|144437699|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-9.5|10.0||||||Additional serotype 5: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.0|-9.5|
72500294|NCT05127486|144530952|SUPERIORITY||LS Mean difference|-0.18|||||TWO_SIDED|95.0|-0.73|0.37|||Mixed Models Analysis|||||0.37|-0.73|
72500295|NCT05127486|144530953|SUPERIORITY||LS Mean difference|-0.49|||||TWO_SIDED|95.0|-0.86|-0.11|||Mixed Models Analysis|||||-0.11|-0.86|
72500296|NCT05127486|144530954|SUPERIORITY||LS Mean difference|4.39|STANDARD_ERROR_OF_MEAN|1.51|||TWO_SIDED|95.0|1.42|7.37|||ANCOVA|||Total score||7.37|1.42|
72500297|NCT05127486|144530954|SUPERIORITY||LS Mean difference|5.24|STANDARD_ERROR_OF_MEAN|1.7|||TWO_SIDED|95.0|1.9|8.58|||ANCOVA|||RF-R||8.58|1.90|
72620819|NCT01887600|144772755|SUPERIORITY||Least squares mean difference|1.604|||<|0.001|TWO_SIDED|95.0|1.39|1.82||LSM difference p-value is for test of differences.|Mixed Models Analysis|||Average Level of Hb Over Weeks 44 to 52. A Mixed Model of Repeated Measures was applied using the visits over weeks 44 to 52. The results were based on the estimated difference between the two treatment arms by visit. The model included treatment arm, region, CV history, visits and visit by treatment as categorical variables and baseline Hb and baseline eGFR as continuous variables.||1.82|1.39|<0.001
72392366|NCT01537393|144292232|OTHER|The primary analysis to assess the effect of PT on 3 year ECD was conducted with a mixed linear model adjusting for baseline ECD, corneal diagnosis, and potential confounders, including storage solution, preparation by eye bank vs surgeon, and accounting for correlated data from participants with 2 study eyes or 2 corneas from the same donor.|Mean Difference (Final Values)|73.0||||0.03|TWO_SIDED|95.0|8.0|138.0|||Mixed Models Analysis|Adjusted for baseline ECD, diagnosis, storage solution, preparation by eye bank/surgeon, participants with 2 study eyes/ 2 corneas from the same donor||||138|8|0.03
72457479|NCT00824850|144437699|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-9.5|10.0||||||Additional serotype 6A: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.0|-9.5|
72457480|NCT00824850|144437699|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-9.5|10.0||||||Additional serotype 7F: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.0|-9.5|
72457481|NCT00824850|144437699|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-9.5|10.0||||||Additional serotype 19A: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.0|-9.5|
72457482|NCT00824850|144437700|SUPERIORITY_OR_OTHER||difference in proportions|9.0|||||TWO_SIDED|95.0|-5.6|25.5||||||7vPnC serotype 4: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||25.5|-5.6|
72457483|NCT00824850|144437700|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-9.5|10.0||||||7vPnC serotype 6B: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.0|-9.5|
72457484|NCT00824850|144437700|SUPERIORITY_OR_OTHER||difference in proportions|2.9|||||TWO_SIDED|95.0|-6.9|14.9||||||7vPnC serotype 9V: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||14.9|-6.9|
72457485|NCT00824850|144437700|SUPERIORITY_OR_OTHER||difference in proportions|5.7|||||TWO_SIDED|95.0|-4.2|19.2||||||7vPnC serotype 14: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||19.2|-4.2|
72457486|NCT00824850|144437700|SUPERIORITY_OR_OTHER||difference in proportions|3.1|||||TWO_SIDED|95.0|-9.3|17.0||||||7vPnC serotype 18C: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||17.0|-9.3|
72457487|NCT00824850|144437700|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-9.4|10.3||||||7vPnC serotype 19F: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.3|-9.4|
72457488|NCT00824850|144437700|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-9.5|10.0||||||7vPnC serotype 23F: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.0|-9.5|
72457489|NCT00824850|144437700|SUPERIORITY_OR_OTHER||difference in proportions|2.9|||||TWO_SIDED|95.0|-6.9|14.9||||||Additional serotype 1: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||14.9|-6.9|
72457490|NCT00824850|144437700|SUPERIORITY_OR_OTHER||difference in proportions|6.9|||||TWO_SIDED|95.0|-7.4|23.4||||||Additional serotype 3: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||23.4|-7.4|
72457491|NCT00824850|144437700|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-9.5|10.0||||||Additional serotype 5: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.0|-9.5|
72457492|NCT00824850|144437700|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-9.5|10.0||||||Additional serotype 6A: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.0|-9.5|
72457493|NCT00824850|144437700|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-9.5|10.0||||||Additional serotype 7F: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.0|-9.5|
72457494|NCT00824850|144437700|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-9.5|10.0||||||Additional serotype 19A: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.0|-9.5|
72500298|NCT05127486|144530954|SUPERIORITY||LS Mean difference|3.88|STANDARD_ERROR_OF_MEAN|1.44|||TWO_SIDED|95.0|1.06|6.71|||ANCOVA|||RF-P||6.71|1.06|
72500299|NCT05127486|144530954|SUPERIORITY||LS Mean difference|3.18|STANDARD_ERROR_OF_MEAN|1.66|||TWO_SIDED|95.0|-0.08|6.44|||ANCOVA|||EF||6.44|-0.08|
72500300|NCT05127486|144530955|SUPERIORITY||LS Mean difference|-2.43|STANDARD_ERROR_OF_MEAN|2.3|||TWO_SIDED|95.0|-6.94|2.08|||ANCOVA|||||2.08|-6.94|
72620820|NCT01887600|144772756|SUPERIORITY||Least squares mean difference|1.492|||<|0.001|TWO_SIDED|95.0|1.14|1.85||LSM Difference p-value is for test of differences.|Mixed Models Analysis|||Average Level of Hb Over Weeks 96 to 104. A Mixed Model of Repeated Measures was applied using the visits over weeks 96 to 104. The results were based on the estimated difference between the two treatment arms by visit. The model included treatment arm, region, CV history, visits and visit by treatment as categorical variables and baseline Hb and baseline eGFR as continuous variables.||1.85|1.14|<0.001
72392367|NCT04518293|144292233|OTHER|The difference between GMRx2 and dual-TA at Week 12 was estimated using a mixed model for repeated measures (MMRM).|LS Means Difference|-5.44|STANDARD_ERROR_OF_MEAN|0.68|<|0.0001|TWO_SIDED|95.0|-6.774|-4.107|||MIANALYZE procedure|||The LS means (LSM) difference (95% CI) in home seated SBP reduction was calculated between GMRx2 and dual-TA arms.||-4.107|-6.774|<.0001
72392368|NCT04518293|144292233|OTHER|The difference between GMRx2 and dual-TI at Week 12 was estimated using a MMRM.|LS Means Difference|-2.49|STANDARD_ERROR_OF_MEAN|0.63|<|0.0001|TWO_SIDED|95.0|-3.723|-1.251|||MIANALYZE procedure|||The LSM difference (95% CI) in home SBP reduction was calculated between GMRx2 and dual-TI arms.||-1.251|-3.723|<.0001
72392369|NCT04518293|144292233|OTHER|The difference between GMRx2 and dual-AI at Week 12 was estimated using a MMRM.|LS Means Difference|-4.42|STANDARD_ERROR_OF_MEAN|0.68|<|0.0001|TWO_SIDED|95.0|-5.758|-3.091|||MIANALYZE procedure|||The LSM difference (95% CI) in home SBP reduction was calculated between GMRx2 and dual-AI arms.||-3.091|-5.758|<.0001
72392370|NCT04518293|144292234|OTHER|The difference between GMRx2 and dual-TA at Week 12 was estimated using a MMRM.|LS Means Difference|-5.6|STANDARD_ERROR_OF_MEAN|0.863|<|0.0001|TWO_SIDED|95.0|-7.307|-3.902|||Mixed Models Analysis|||The LSM difference (95% CI) in clinic SBP reduction was calculated between GMRx2 between dual-TA arms.||-3.902|-7.307|<.0001
72392371|NCT04518293|144292234|OTHER|The difference between GMRx2 and dual-TI at Week 12 was estimated using a MMRM.|LS Means Difference|-4.33|STANDARD_ERROR_OF_MEAN|1.212||0.0005|TWO_SIDED|95.0|-6.718|-1.933|||Mixed Models Analysis|||The LSM difference (95% CI) in clinic SBP reduction was calculated between GMRx2 and dual-TI arms.||-1.933|-6.718|0.0005
72392372|NCT04518293|144292234|OTHER|The difference between GMRx2 and dual-AI at Week 12 was estimated using a MMRM.|LS Means Difference|-6.33|STANDARD_ERROR_OF_MEAN|0.837|<|0.0001|TWO_SIDED|95.0|-7.984|-4.68|||Mixed Models Analysis|||The LSM difference (95% CI) in clinic SBP reduction was calculated between GMRx2 and dual-AI arms.||-4.680|-7.984|<.0001
72392373|NCT04518293|144292235|OTHER|The difference between GMRx2 and dual-TA at Week 6 was estimated using MMRM.|LS Means Difference|-5.01|STANDARD_ERROR_OF_MEAN|0.858|<|0.0001|TWO_SIDED|95.0|-6.703|-3.317|||Mixed Models Analysis|||The LSM difference (95% CI) in clinic SBP reduction was calculated between GMRx2 and dual-TA arms.||-3.317|-6.703|<.0001
72392374|NCT04518293|144292235|OTHER|The difference between GMRx2 and dual-TI at Week 6 was estimated using MMRM.|LS Means Difference|-3.5|STANDARD_ERROR_OF_MEAN|0.91||0.0002|TWO_SIDED|95.0|-5.293|-1.7|||Mixed Models Analysis|||The LSM difference (95% CI) in clinic SBP reduction was calculated between GMRx2 and dual-TI arms.||-1.700|-5.293|0.0002
72392375|NCT04518293|144292235|OTHER|The difference between GMRx2 and dual-AI at Week 6 was estimated using MMRM.|LS Means Difference|-5.35|STANDARD_ERROR_OF_MEAN|0.965|<|0.0001|TWO_SIDED|95.0|-7.251|-3.444|||Mixed Models Analysis|||The LSM difference (95% CI) in clinic SBP reduction was calculated between GMRx2 and dual-AI arms.||-3.444|-7.251|<.0001
72392376|NCT04518293|144292236|OTHER|The difference between GMRx2 and dual-TA at Week 12 was estimated using MMRM.|LS Means Difference|-3.72|STANDARD_ERROR_OF_MEAN|0.49|<|0.0001|TWO_SIDED|95.0|-4.692|-2.757|||Mixed Models Analysis|||The LSM difference (95% CI) in clinic DBP reduction was calculated between GMRx2 and dual-TA arms.||-2.757|-4.692|<.0001
72392377|NCT04518293|144292236|OTHER|The difference between GMRx2 and dual-TI at Week 12 was estimated using MMRM.|LS Means Difference|-3.51|STANDARD_ERROR_OF_MEAN|0.702|<|0.0001|TWO_SIDED|95.0|-4.897|-2.128|||Mixed Models Analysis|||The LSM difference (95% CI) in clinic DBP reduction was calculated between GMRx2 and dual-TI arms.||-2.128|-4.897|<.0001
72392378|NCT04518293|144292236|OTHER|The difference between GMRx2 and dual-AI at Week 12 was estimated using MMRM.|LS Means Difference|-4.5|STANDARD_ERROR_OF_MEAN|0.665|<|0.0001|TWO_SIDED|95.0|-5.812|-3.189|||Mixed Models Analysis|||The LSM difference (95% CI) in clinic DBP reduction was calculated between GMRx2 and dual-AI arms.||-3.189|-5.812|<.0001
72392379|NCT04518293|144292237|OTHER|The difference between GMRx2 and dual-TA at Week 6 was estimated using MMRM.|LS Means Difference|-2.43|STANDARD_ERROR_OF_MEAN|0.487|<|0.0001|TWO_SIDED|95.0|-3.392|-1.469|||Mixed Models Analysis|||The LSM difference (95% CI) in clinic DBP reduction was calculated between GMRx2 and dual-TA arms.||-1.469|-3.392|<.0001
72392380|NCT04518293|144292237|OTHER|The difference between GMRx2 and dual-TI at Week 6 was estimated using MMRM.|LS Means Difference|-2.29|STANDARD_ERROR_OF_MEAN|0.55|<|0.0001|TWO_SIDED|95.0|-3.371|-1.201|||Mixed Models Analysis|||The LSM difference (95% CI) in clinic DBP reduction was calculated between GMRx2 and dual-TI arms.||-1.201|-3.371|<.0001
72392381|NCT04518293|144292237|OTHER|The difference between GMRx2 and dual-AI at Week 6 was estimated using MMRM.|LS Means Difference|-3.77|STANDARD_ERROR_OF_MEAN|0.562|<|0.0001|TWO_SIDED|95.0|-4.882|-2.664|||Mixed Models Analysis|||The LSM difference (95% CI) in clinic DBP reduction was calculated between GMRx2 and dual-AI arms.||-2.664|-4.882|<.0001
72392382|NCT04518293|144292238|OTHER||Risk Difference (RD)|12.52||||0.0003|TWO_SIDED|95.0|5.63|19.487|||Wald test|||The difference between GMRx2 and TA at Week 12 was estimated using Generalized Estimating Equation.||19.487|5.630|0.0003
72392383|NCT04518293|144292238|OTHER||Risk Difference (RD)|13.36||||0.0001|TWO_SIDED|95.0|6.392|20.394|||Wald test|||The difference between GMRx2 and TI at Week 12 was estimated using Generalized Estimating Equation.||20.394|6.392|0.0001
72392384|NCT04518293|144292238|OTHER||Risk Difference (RD)|20.97|||<|0.0001|TWO_SIDED|95.0|13.812|28.013|||Wald test|||The difference between GMRx2 and AI at Week 12 was estimated using Generalized Estimating Equation.||28.013|13.812|<.0001
72392385|NCT04518293|144292239|OTHER||Risk Difference (RD)|10.31||||0.0044|TWO_SIDED|95.0|3.044|17.535|||Wald test|||The difference between GMRx2 and TA at Week 6 was estimated using Generalized Estimating Equation.||17.535|3.044|0.0044
72392386|NCT04518293|144292239|OTHER||Risk Difference (RD)|8.08||||0.0262|TWO_SIDED|95.0|0.804|15.373|||Wald test|||The difference between GMRx2 and TI at Week 6 was estimated using Generalized Estimating Equation.||15.373|0.804|0.0262
72392387|NCT04518293|144292239|OTHER||Risk Difference (RD)|18.59|||<|0.0001|TWO_SIDED|95.0|11.201|25.746|||Wald test|||The difference between GMRx2 and AI at Week 6 was estimated using Generalized Estimating Equation.||25.746|11.201|<.0001
72392388|NCT04518293|144292240|OTHER||Risk Difference (RD)|16.51|||<|0.0001|TWO_SIDED|95.0|9.707|22.837|||Wald test|||The difference between GMRx2 and TA at Week 12 was estimated using Generalized Estimating Equation.||22.837|9.707|<.0001
72392389|NCT04518293|144292240|OTHER||Risk Difference (RD)|12.03||||0.0004|TWO_SIDED|95.0|4.982|18.658|||Wald test|||The difference between GMRx2 and TI at Week 12 was estimated using Generalized Estimating Equation.||18.658|4.982|0.0004
72392390|NCT04518293|144292240|OTHER||Risk Difference (RD)|18.19|||<|0.0001|TWO_SIDED|95.0|11.412|24.432|||Wald test|||The difference between GMRx2 and AI at Week 12 was estimated using Generalized Estimating Equation.||24.432|11.412|<.0001
72457495|NCT00824850|144437701|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-10.2|10.9||||||7vPnC serotype 4: difference in proportions, \[7vPnC / 13vPnC) - (MnCC / 13vPnC), expressed as a percentage, along with exact 2-sided confidence interval.||10.9|-10.2|
72457496|NCT00824850|144437701|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-10.0|10.1||||||7vPnC serotype 6B: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.1|-10.0|
72457497|NCT00824850|144437701|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-9.4|10.3||||||7vPnC serotype 9V: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.3|-9.4|
72457498|NCT00824850|144437701|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-9.4|10.3||||||7vPnC serotype 14: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.3|-9.4|
72457499|NCT00824850|144437701|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-9.5|10.0||||||7vPnC serotype 18C: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.0|-9.5|
72457500|NCT00824850|144437701|SUPERIORITY_OR_OTHER||difference in proportions|-2.6|||||TWO_SIDED|95.0|-13.9|8.0||||||7vPnC serotype 19F: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||8.0|-13.9|
72457501|NCT00824850|144437701|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-10.0|10.1||||||7vPnC serotype 23F: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.1|-10.0|
72457502|NCT00824850|144437701|SUPERIORITY_OR_OTHER||difference in proportions|2.9|||||TWO_SIDED|95.0|-6.7|15.3||||||Additional serotype 1: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||15.3|-6.7|
72457503|NCT00824850|144437701|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-9.5|10.0||||||Additional serotype 3: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.0|-9.5|
72457504|NCT00824850|144437701|SUPERIORITY_OR_OTHER||difference in proportions|0.9|||||TWO_SIDED|95.0|-15.0|17.6||||||Additional serotype 5: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||17.6|-15.0|
72457505|NCT00824850|144437701|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-9.4|10.3||||||Additional serotype 6A: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.3|-9.4|
72457506|NCT00824850|144437701|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-10.0|10.1||||||Additional serotype 7F: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.1|-10.0|
72457507|NCT00824850|144437701|SUPERIORITY_OR_OTHER||difference in proportions|-2.6|||||TWO_SIDED|95.0|-13.9|7.6||||||Additional serotype 19A: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||7.6|-13.9|
72370446|NCT00488683|144251631|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|-0.04||||0.75||95.0||||Values from Group 1, 2 and 3 were combined for this analysis.|Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccinations and serogroup specific IgG concentration at 12 months of age for the serogroup A||||0.75
72457508|NCT00824850|144437702|SUPERIORITY_OR_OTHER||difference in proportions|-2.6|||||TWO_SIDED|95.0|-13.9|8.0||||||7vPnC serotype 4: difference in proportions, \[7vPnC / 13vPnC) - (MnCC / 13vPnC), expressed as a percentage, along with exact 2-sided confidence interval.||8.0|-13.9|
72457509|NCT00824850|144437702|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-10.2|10.6||||||7vPnC serotype 6B: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.6|-10.2|
72457510|NCT00824850|144437702|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-9.4|10.3||||||7vPnC serotype 9V: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.3|-9.4|
72457511|NCT00824850|144437702|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-9.5|10.3||||||7vPnC serotype 14: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.3|-9.5|
72457512|NCT00824850|144437702|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-10.0|10.1||||||7vPnC serotype 18C: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.1|-10.0|
72457513|NCT00824850|144437702|SUPERIORITY_OR_OTHER||difference in proportions|-2.8|||||TWO_SIDED|95.0|-16.8|10.1||||||7vPnC serotype 19F: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.1|-16.8|
72457514|NCT00824850|144437702|SUPERIORITY_OR_OTHER||difference in proportions|3.0|||||TWO_SIDED|95.0|-9.1|16.6||||||7vPnC serotype 23F: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||16.6|-9.1|
72457515|NCT00824850|144437702|SUPERIORITY_OR_OTHER||difference in proportions|2.9|||||TWO_SIDED|95.0|-7.1|15.0||||||Additional serotype 1: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||15.0|-7.1|
72457516|NCT00824850|144437702|SUPERIORITY_OR_OTHER||difference in proportions|-2.6|||||TWO_SIDED|95.0|-13.9|8.0||||||Additional serotype 3: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||8.0|-13.9|
72457517|NCT00824850|144437702|SUPERIORITY_OR_OTHER||difference in proportions|1.2|||||TWO_SIDED|95.0|-14.8|18.2||||||Additional serotype 5: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||18.2|-14.8|
72370447|NCT00488683|144251631|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.11||||0.27||95.0||||Values from Group 1, 2 and 3 were combined for this analysis.|Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccinations and serogroup specific IgG concentration at 12 months of age for the serogroup C||||0.27
72500301|NCT03193866|144530961|SUPERIORITY||Difference in proportion|1.5|||||TWO_SIDED|95.0|-1.8|4.9||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||4.9|-1.8|
72500302|NCT03193866|144530961|SUPERIORITY||Difference in proportion|-0.2|||||TWO_SIDED|95.0|-6.8|6.5||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||6.5|-6.8|
72563017|NCT00292227|144658095|NON_INFERIORITY_OR_EQUIVALENCE|A standard deviation of 12ms was assumed for sample size calculation. Sample size was calculated to have 90% power to show the non-inferiority of rotigotine against placebo with respect to the non-inferiority margin of 10ms (α=0.05, 1-sided).|Mean Difference (Net)|0.21||||||90.0|-1.76|2.17|||ANCOVA|The ANCOVA model included the factors site, treatment, gender, and time-matched baseline QTcI as covariate.|The direction of the estimate is Rotigotine - Placebo. Mean difference was estimated from the ANCOVA model.|The analysis was based on a non-inferiority comparison of rotigotine vs placebo using a 1-sided 95% confidence interval (or, equivalently, the upper limit of 2-sided 90% confidence interval) for the time-matched changes from Baseline in QTcI.||2.17|-1.76|
72563018|NCT00292227|144658096|NON_INFERIORITY_OR_EQUIVALENCE|A standard deviation of 12ms was assumed for sample size calculation. Sample size was calculated to have 90% power to show the non-inferiority of rotigotine against placebo with respect to the non-inferiority margin of 10ms (α=0.05, 1-sided).|Mean Difference (Net)|-1.23||||||90.0|-2.99|0.53|||ANCOVA|The ANCOVA model included the factors site, treatment, gender, and time-matched baseline QTcI as covariate.|The direction of the estimate is Rotigotine - Placebo. Mean difference was estimated from the ANCOVA model.|The analysis was based on a non-inferiority comparison of rotigotine vs placebo using a 1-sided 95% confidence interval (or, equivalently, the upper limit of 2-sided 90% confidence interval) for the time-matched changes from Baseline in QTcI.||0.53|-2.99|
72563019|NCT00292227|144658097|NON_INFERIORITY_OR_EQUIVALENCE|A standard deviation of 12ms was assumed for sample size calculation. Sample size was calculated to have 90% power to show the non-inferiority of rotigotine against placebo with respect to the non-inferiority margin of 10ms (α=0.05, 1-sided).|Mean Difference (Net)|-1.62||||||90.0|-3.87|0.63|||ANCOVA|The ANCOVA model included the factors site, treatment, gender, and time-matched baseline QTcI as covariate.|The direction of the estimate is Rotigotine - Placebo. Mean difference was estimated from the ANCOVA model.|The analysis was based on a non-inferiority comparison of rotigotine vs placebo using a 1-sided 95% confidence interval (or, equivalently, the upper limit of 2-sided 90% confidence interval) for the time-matched changes from Baseline in QTcI.||0.63|-3.87|
72563020|NCT00292227|144658098|NON_INFERIORITY_OR_EQUIVALENCE|A standard deviation of 12ms was assumed for sample size calculation. Sample size was calculated to have 90% power to show the non-inferiority of rotigotine against placebo with respect to the non-inferiority margin of 10ms (α=0.05, 1-sided).|Mean Difference (Net)|-0.81||||||90.0|-2.55|0.93|||ANCOVA|The ANCOVA model included the factors site, treatment, gender, and time-matched baseline QTcI as covariate.|The direction of the estimate is Rotigotine - Placebo. Mean difference was estimated from the ANCOVA model.|The analysis was based on a non-inferiority comparison of rotigotine vs placebo using a 1-sided 95% confidence interval (or, equivalently, the upper limit of 2-sided 90% confidence interval) for the time-matched changes from Baseline in QTcI.||0.93|-2.55|
72563021|NCT00292227|144658099|NON_INFERIORITY_OR_EQUIVALENCE|A standard deviation of 12ms was assumed for sample size calculation. Sample size was calculated to have 90% power to show the non-inferiority of rotigotine against placebo with respect to the non-inferiority margin of 10ms (α=0.05, 1-sided).|Mean Difference (Net)|-0.37||||||90.0|-2.13|1.39|||ANCOVA|The ANCOVA model included the factors site, treatment, gender, and time-matched baseline QTcI as covariate.|The direction of the estimate is Rotigotine - Placebo. Mean difference was estimated from the ANCOVA model.|The analysis was based on a non-inferiority comparison of rotigotine vs placebo using a 1-sided 95% confidence interval (or, equivalently, the upper limit of 2-sided 90% confidence interval) for the time-matched changes from Baseline in QTcI.||1.39|-2.13|
72563022|NCT00292227|144658100|NON_INFERIORITY_OR_EQUIVALENCE|A standard deviation of 12ms was assumed for sample size calculation. Sample size was calculated to have 90% power to show the non-inferiority of rotigotine against placebo with respect to the non-inferiority margin of 10ms (α=0.05, 1-sided).|Mean Difference (Net)|-0.68||||||90.0|-2.6|1.25|||ANCOVA|The ANCOVA model included the factors site, treatment, gender, and time-matched baseline QTcI as covariate.|The direction of the estimate is Rotigotine - Placebo. Mean difference was estimated from the ANCOVA model.|The analysis was based on a non-inferiority comparison of rotigotine vs placebo using a 1-sided 95% confidence interval (or, equivalently, the upper limit of 2-sided 90% confidence interval) for the time-matched changes from Baseline in QTcI.||1.25|-2.60|
72370448|NCT00488683|144251631|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.2||||0.07||95.0||||Values from Group 1, 2 and 3 were combined for this analysis.|Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccinations and serogroup specific IgG concentration at 12 months of age for the serogroup W-135||||0.07
72620821|NCT01887600|144772757|SUPERIORITY||Hazard Ratio (HR)|19.001|||<|0.001|TWO_SIDED|95.0|11.98|30.15|||Regression, Cox|||Time to Achieve the First Hb Response. Hazard ratio was calculated using stratified Cox Proportional Hazards Regression stratifying on CV history and region and adjusting on Hb and eGFR at baseline as continuous covariates.||30.15|11.98|<0.001
72370449|NCT00488683|144251631|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.23||||0.06||95.0||||Values from Group 1, 2 and 3 were combined for this analysis.|Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccinations and serogroup specific IgG concentration at 12 months of age for the serogroup Y||||0.06
72392391|NCT04518293|144292241|OTHER||Risk Difference (RD)|10.45||||0.0007|TWO_SIDED|95.0|3.993|16.433|||Wald test|||The difference between GMRx2 and TA at Week 6 was estimated using Generalized Estimating Equation.||16.433|3.993|0.0007
72457518|NCT00824850|144437702|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-9.5|10.0||||||Additional serotype 6A: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.0|-9.5|
72457519|NCT00824850|144437702|SUPERIORITY_OR_OTHER||difference in proportions|3.0|||||TWO_SIDED|95.0|-6.8|15.8||||||Additional serotype 7F: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||15.8|-6.8|
72500303|NCT03193866|144530961|SUPERIORITY||Difference in proportion|1.3|||||TWO_SIDED|95.0|-1.7|4.3||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||4.3|-1.7|
72500304|NCT03193866|144530961|SUPERIORITY||Difference in proportion|-0.9|||||TWO_SIDED|95.0|-4.3|2.4||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||2.4|-4.3|
72500305|NCT03193866|144530961|SUPERIORITY||Difference in proportion|1.7|||||TWO_SIDED|95.0|-1.3|4.6||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||4.6|-1.3|
72500306|NCT03193866|144530961|SUPERIORITY||Difference in proportion|0.3|||||TWO_SIDED|95.0|-2.7|3.3||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||3.3|-2.7|
72500307|NCT03193866|144530961|SUPERIORITY||Difference in proportion|1.2|||||TWO_SIDED|95.0|-2.0|4.4||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||4.4|-2.0|
72500308|NCT03193866|144530961|SUPERIORITY||Difference in proportion|2.0|||||TWO_SIDED|95.0|-3.2|7.1||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||7.1|-3.2|
72500309|NCT03193866|144530962|SUPERIORITY||Difference in proportion|0.7|||||TWO_SIDED|95.0|-7.5|8.8||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||8.8|-7.5|
72500310|NCT03193866|144530962|SUPERIORITY||Difference in proportion|-2.9|||||TWO_SIDED|95.0|-18.5|12.8||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||12.8|-18.5|
72620822|NCT01887600|144772758|SUPERIORITY||Least squares mean difference|0.396|||<|0.001|TWO_SIDED|95.0|0.29|0.5||LSM Difference p-value is for test of differences.|Mixed Models Analysis|||Hb change from BL to week 1. A Mixed Model of Repeated Measures was applied using the visits up to week 104. The results were based on the estimated difference between the two treatment arms by visit. The model included treatment arm, region, CV history, visits and visit by treatment as categorical variables and baseline Hb and baseline eGFR as continuous variables.||0.50|0.29|<0.001
72370450|NCT00488683|144251631|SUPERIORITY_OR_OTHER||R-square|0.0029||||||95.0||||Values from Group 1, 2 and 3 were combined for this analysis.|Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccinations and serogroup specific IgG concentration at 12 months of age for the serogroup A||||
72392392|NCT04518293|144292241|OTHER||Risk Difference (RD)|8.93||||0.0046|TWO_SIDED|95.0|2.337|15.058|||Wald test|||The difference between GMRx2 and TI at Week 6 was estimated using Generalized Estimating Equation.||15.058|2.337|0.0046
72370451|NCT00488683|144251631|SUPERIORITY_OR_OTHER||R-square|0.0059||||||95.0||||Values from Group 1, 2 and 3 were combined for this analysis.|Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccinations and serogroup specific IgG concentration at 12 months of age for the serogroup C||||
72457520|NCT00824850|144437702|SUPERIORITY_OR_OTHER||difference in proportions|-2.6|||||TWO_SIDED|95.0|-13.9|7.6||||||Additional serotype 19A: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||7.6|-13.9|
72457521|NCT00824850|144437703|SUPERIORITY_OR_OTHER||geometric mean fold rise|29.47|||||TWO_SIDED|95.0|17.61|49.33|||||Confidence intervals (CI) for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 4: Geometric mean fold rises (GMFRs) were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||49.33|17.61|
72457522|NCT00824850|144437703|SUPERIORITY_OR_OTHER||geometric mean fold rise|11.34|||||TWO_SIDED|95.0|8.49|15.13|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 6B: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||15.13|8.49|
72457523|NCT00824850|144437703|SUPERIORITY_OR_OTHER||geometric mean fold rise|5.58|||||TWO_SIDED|95.0|4.06|7.67|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 9V: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||7.67|4.06|
72457524|NCT00824850|144437703|SUPERIORITY_OR_OTHER||geometric mean fold rise|71.09|||||TWO_SIDED|95.0|40.74|124.08|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 14: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||124.08|40.74|
72457525|NCT00824850|144437703|SUPERIORITY_OR_OTHER||geometric mean fold rise|7.91|||||TWO_SIDED|95.0|4.92|12.73|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 18C: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||12.73|4.92|
72457526|NCT00824850|144437703|SUPERIORITY_OR_OTHER||geometric mean fold rise|4.56|||||TWO_SIDED|95.0|2.87|7.26|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 19F: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||7.26|2.87|
72457527|NCT00824850|144437703|SUPERIORITY_OR_OTHER||geometric mean fold rise|6.85|||||TWO_SIDED|95.0|4.51|10.42|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 23F: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||10.42|4.51|
72457528|NCT00824850|144437703|SUPERIORITY_OR_OTHER||geometric mean fold rise|11.1|||||TWO_SIDED|95.0|6.98|17.64|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 1: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||17.64|6.98|
72457529|NCT00824850|144437703|SUPERIORITY_OR_OTHER||geometric mean fold rise|1.68|||||TWO_SIDED|95.0|1.37|2.07|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 3: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||2.07|1.37|
72457530|NCT00824850|144437703|SUPERIORITY_OR_OTHER||geometric mean fold rise|2.1|||||TWO_SIDED|95.0|1.52|2.9|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 5: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||2.90|1.52|
72457531|NCT00824850|144437703|SUPERIORITY_OR_OTHER||geometric mean fold rise|7.7|||||TWO_SIDED|95.0|4.77|12.42|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 6A: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||12.42|4.77|
72457532|NCT00824850|144437703|SUPERIORITY_OR_OTHER||geometric mean fold rise|7.2|||||TWO_SIDED|95.0|4.95|10.48|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 7F: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||10.48|4.95|
72620823|NCT01887600|144772758|SUPERIORITY||Least squares mean difference|0.938|||<|0.001|TWO_SIDED|95.0|0.81|1.07||LSM Difference p-value is for test of differences.|Mixed Models Analysis|||Hb change from BL to week 2. A Mixed Model of Repeated Measures was applied using the visits up to Week 104. The results were based on the estimated difference between the two treatment arms by visit. The model included treatment arm, region, CV history, visits and visit by treatment as categorical variables and baseline Hb and baseline eGFR as continuous variables.||1.07|0.81|<0.001
72392393|NCT04518293|144292241|OTHER||Risk Difference (RD)|12.19|||<|0.0001|TWO_SIDED|95.0|5.792|18.073|||Wald test|||||18.073|5.792|<.0001
72457533|NCT00824850|144437703|SUPERIORITY_OR_OTHER||geometric mean fold rise|3.02|||||TWO_SIDED|95.0|2.23|4.1|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 19A: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||4.10|2.23|
72457534|NCT00824850|144437704|SUPERIORITY_OR_OTHER||geometric mean fold rise|19.68|||||TWO_SIDED|95.0|9.99|38.77|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 4: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||38.77|9.99|
72500311|NCT03193866|144530962|SUPERIORITY||Difference in proportion|-0.1|||||TWO_SIDED|95.0|-8.8|8.6||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||8.6|-8.8|
72500312|NCT03193866|144530962|SUPERIORITY||Difference in proportion|-0.5|||||TWO_SIDED|95.0|-8.1|7.2||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||7.2|-8.1|
72500313|NCT03193866|144530962|SUPERIORITY||Difference in proportion|1.6|||||TWO_SIDED|95.0|-5.7|8.9||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||8.9|-5.7|
72500314|NCT03193866|144530962|SUPERIORITY||Difference in proportion|1.6|||||TWO_SIDED|95.0|-4.7|8.0||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||8.0|-4.7|
72500315|NCT03193866|144530962|SUPERIORITY||Difference in proportion|0.9|||||TWO_SIDED|95.0|-6.2|7.9||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||7.9|-6.2|
72500316|NCT03193866|144530962|SUPERIORITY||Difference in proportion|-1.6|||||TWO_SIDED|95.0|-10.8|7.5||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||7.5|-10.8|
72500317|NCT03193866|144530963|SUPERIORITY||Mean Difference (Net)|0.4|||||TWO_SIDED|95.0|-2.5|3.3||||||Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||3.3|-2.5|
72500318|NCT03193866|144530963|SUPERIORITY||Mean Difference (Net)|-4.5|||||TWO_SIDED|95.0|-12.5|3.4||||||Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||3.4|-12.5|
72500319|NCT03193866|144530963|SUPERIORITY||Mean Difference (Net)|-0.3|||||TWO_SIDED|95.0|-2.5|1.8||||||Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||1.8|-2.5|
72500320|NCT03193866|144530963|SUPERIORITY||Mean Difference (Net)|-2.5|||||TWO_SIDED|95.0|-4.9|-0.1||||||Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||-0.1|-4.9|
72563023|NCT00292227|144658101|NON_INFERIORITY_OR_EQUIVALENCE|A standard deviation of 12ms was assumed for sample size calculation. Sample size was calculated to have 90% power to show the non-inferiority of rotigotine against placebo with respect to the non-inferiority margin of 10ms (α=0.05, 1-sided).|Mean Difference (Net)|1.17||||||90.0|-0.69|3.03|||ANCOVA|The ANCOVA model included the factors site, treatment, gender, and time-matched baseline QTcI as covariate.|The direction of the estimate is Rotigotine - Placebo. Mean difference was estimated from the ANCOVA model.|The analysis was based on a non-inferiority comparison of rotigotine vs placebo using a 1-sided 95% confidence interval (or, equivalently, the upper limit of 2-sided 90% confidence interval) for the time-matched changes from Baseline in QTcI.||3.03|-0.69|
72563024|NCT00292227|144658102|NON_INFERIORITY_OR_EQUIVALENCE|A standard deviation of 12ms was assumed for sample size calculation. Sample size was calculated to have 90% power to show the non-inferiority of rotigotine against placebo with respect to the non-inferiority margin of 10ms (α=0.05, 1-sided).|Mean Difference (Net)|0.8||||||90.0|-1.14|2.73|||ANCOVA|The ANCOVA model included the factors site, treatment, gender, and time-matched baseline QTcI as covariate.|The direction of the estimate is Rotigotine - Placebo. Mean difference was estimated from the ANCOVA model.|The analysis was based on a non-inferiority comparison of rotigotine vs placebo using a 1-sided 95% confidence interval (or, equivalently, the upper limit of 2-sided 90% confidence interval) for the time-matched changes from Baseline in QTcI.||2.73|-1.14|
72457535|NCT00824850|144437704|SUPERIORITY_OR_OTHER||geometric mean fold rise|5.7|||||TWO_SIDED|95.0|3.9|8.33|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 6B: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||8.33|3.90|
72457536|NCT00824850|144437704|SUPERIORITY_OR_OTHER||geometric mean fold rise|2.78|||||TWO_SIDED|95.0|2.16|3.57|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 9V: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||3.57|2.16|
72392394|NCT04518293|144292242|OTHER|The difference between GMRx2 and dual-TA at Week 6 was estimated using MMRM.|LS Means Difference|-6.11|STANDARD_ERROR_OF_MEAN|0.495|<|0.0001|TWO_SIDED|95.0|-7.086|-5.144|||Mixed Models Analysis|||The LSM difference (95% CI) in home SBP reduction was calculated between GMRx2 and dual-TA arms.||-5.144|-7.086|<.0001
72457537|NCT00824850|144437704|SUPERIORITY_OR_OTHER||geometric mean fold rise|23.46|||||TWO_SIDED|95.0|13.17|41.79|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 14: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||41.79|13.17|
72457538|NCT00824850|144437704|SUPERIORITY_OR_OTHER||geometric mean fold rise|13.68|||||TWO_SIDED|95.0|8.94|20.92|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 18C: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||20.92|8.94|
72457539|NCT00824850|144437704|SUPERIORITY_OR_OTHER||geometric mean fold rise|8.98|||||TWO_SIDED|95.0|6.21|12.97|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 19F: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||12.97|6.21|
72457540|NCT00824850|144437704|SUPERIORITY_OR_OTHER||geometric mean fold rise|9.0|||||TWO_SIDED|95.0|5.91|13.72|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 23F: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||13.72|5.91|
72457541|NCT00824850|144437704|SUPERIORITY_OR_OTHER||geometric mean fold rise|7.58|||||TWO_SIDED|95.0|5.36|10.72|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 1: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||10.72|5.36|
72457542|NCT00824850|144437704|SUPERIORITY_OR_OTHER||geometric mean fold rise|1.56|||||TWO_SIDED|95.0|1.3|1.86|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 3: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||1.86|1.30|
72457543|NCT00824850|144437704|SUPERIORITY_OR_OTHER||geometric mean fold rise|1.93|||||TWO_SIDED|95.0|1.43|2.6|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 5: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||2.60|1.43|
72457544|NCT00824850|144437704|SUPERIORITY_OR_OTHER||geometric mean fold rise|4.46|||||TWO_SIDED|95.0|3.09|6.45|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 6A: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||6.45|3.09|
72500321|NCT03193866|144530963|SUPERIORITY||Mean Difference (Net)|-0.7|||||TWO_SIDED|95.0|-2.6|1.1||||||Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||1.1|-2.6|
72500322|NCT03193866|144530963|SUPERIORITY||Mean Difference (Net)|-1.9|||||TWO_SIDED|95.0|-4.2|0.3||||||Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||0.3|-4.2|
72392395|NCT04518293|144292242|OTHER|The difference between GMRx2 and dual-TI at Week 6 was estimated using MMRM.|LS Means Difference|-3.0|STANDARD_ERROR_OF_MEAN|0.543|<|0.0001|TWO_SIDED|95.0|-4.06|-1.932|||Mixed Models Analysis|||The LSM difference (95% CI) in home SBP reduction was calculated between GMRx2 and dual-TI arms.||-1.932|-4.060|<.0001
72500323|NCT03193866|144530963|SUPERIORITY||Mean Difference (Net)|-1.8|||||TWO_SIDED|95.0|-4.0|0.3||||||Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||0.3|-4.0|
72620824|NCT01887600|144772758|SUPERIORITY||Least squares mean difference|1.471|||<|0.001|TWO_SIDED|95.0|1.3|1.64||LSM Difference p-value is for test of differences.|Mixed Models Analysis|||Hb change from BL to week 4. A Mixed Model of Repeated Measures was applied using the visits up to Week 104. The results were based on the estimated difference between the two treatment arms by visit. The model included treatment arm, region, CV history, visits and visit by treatment as categorical variables and baseline Hb and baseline eGFR as continuous variables.||1.64|1.30|<0.001
72370452|NCT00488683|144251631|SUPERIORITY_OR_OTHER||R-square|0.04||||||95.0||||Values from Group 1, 2 and 3 were combined for this analysis.|Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccinations and serogroup specific IgG concentration at 12 months of age for the serogroup W-135||||
72457545|NCT00824850|144437704|SUPERIORITY_OR_OTHER||geometric mean fold rise|5.32|||||TWO_SIDED|95.0|3.65|7.75|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 7F: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||7.75|3.65|
72457546|NCT00824850|144437704|SUPERIORITY_OR_OTHER||geometric mean fold rise|3.27|||||TWO_SIDED|95.0|2.49|4.28|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 19A: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||4.28|2.49|
72457547|NCT00824850|144437705|SUPERIORITY_OR_OTHER||geometric mean fold rise|15.86|||||TWO_SIDED|95.0|9.16|27.46|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 4: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||27.46|9.16|
72457548|NCT00824850|144437705|SUPERIORITY_OR_OTHER||geometric mean fold rise|5.01|||||TWO_SIDED|95.0|3.5|7.16|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 6B: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||7.16|3.50|
72457549|NCT00824850|144437705|SUPERIORITY_OR_OTHER||geometric mean fold rise|3.86|||||TWO_SIDED|95.0|2.93|5.09|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 9V: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||5.09|2.93|
72457550|NCT00824850|144437705|SUPERIORITY_OR_OTHER||geometric mean fold rise|17.57|||||TWO_SIDED|95.0|11.11|27.79|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 14: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||27.79|11.11|
72457551|NCT00824850|144437705|SUPERIORITY_OR_OTHER||geometric mean fold rise|4.22|||||TWO_SIDED|95.0|2.86|6.23|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 18C: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||6.23|2.86|
72457552|NCT00824850|144437705|SUPERIORITY_OR_OTHER||geometric mean fold rise|2.54|||||TWO_SIDED|95.0|1.78|3.62|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 19F: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||3.62|1.78|
72500324|NCT03193866|144530963|SUPERIORITY||Mean Difference (Net)|2.6|||||TWO_SIDED|95.0|-0.6|5.8||||||Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||5.8|-0.6|
72457553|NCT00824850|144437705|SUPERIORITY_OR_OTHER||geometric mean fold rise|4.21|||||TWO_SIDED|95.0|2.86|6.19|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 23F: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||6.19|2.86|
72457554|NCT00824850|144437705|SUPERIORITY_OR_OTHER||geometric mean fold rise|4.23|||||TWO_SIDED|95.0|2.79|6.42|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 1: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||6.42|2.79|
72457555|NCT00824850|144437705|SUPERIORITY_OR_OTHER||geometric mean fold rise|1.63|||||TWO_SIDED|95.0|1.3|2.05|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 3: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||2.05|1.30|
72457556|NCT00824850|144437705|SUPERIORITY_OR_OTHER||geometric mean fold rise|1.67|||||TWO_SIDED|95.0|1.3|2.14|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 5: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||2.14|1.30|
72457557|NCT00824850|144437705|SUPERIORITY_OR_OTHER||geometric mean fold rise|3.6|||||TWO_SIDED|95.0|2.39|5.42|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 6A: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||5.42|2.39|
72457558|NCT00824850|144437705|SUPERIORITY_OR_OTHER||geometric mean fold rise|3.41|||||TWO_SIDED|95.0|2.42|4.82|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 7F: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||4.82|2.42|
72457559|NCT00824850|144437705|SUPERIORITY_OR_OTHER||geometric mean fold rise|1.9|||||TWO_SIDED|95.0|1.6|2.26|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 19A: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||2.26|1.60|
72457560|NCT00824850|144437706|SUPERIORITY_OR_OTHER||geometric mean fold rise|8.36|||||TWO_SIDED|95.0|4.5|15.56|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 4: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||15.56|4.50|
72457561|NCT00824850|144437706|SUPERIORITY_OR_OTHER||geometric mean fold rise|2.37|||||TWO_SIDED|95.0|1.78|3.16|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 6B: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||3.16|1.78|
72457562|NCT00824850|144437706|SUPERIORITY_OR_OTHER||geometric mean fold rise|2.02|||||TWO_SIDED|95.0|1.63|2.49|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 9V: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||2.49|1.63|
72457563|NCT00824850|144437706|SUPERIORITY_OR_OTHER||geometric mean fold rise|6.61|||||TWO_SIDED|95.0|4.31|10.15|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 14: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||10.15|4.31|
72370453|NCT00488683|144251631|SUPERIORITY_OR_OTHER||R-square|0.21||||||95.0||||Values from Group 1, 2 and 3 were combined for this analysis.|Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccinations and serogroup specific IgG concentration at 12 months of age for the serogroup Y||||
72457564|NCT00824850|144437706|SUPERIORITY_OR_OTHER||geometric mean fold rise|4.92|||||TWO_SIDED|95.0|3.34|7.26|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 18C: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||7.26|3.34|
72457565|NCT00824850|144437706|SUPERIORITY_OR_OTHER||geometric mean fold rise|2.73|||||TWO_SIDED|95.0|2.08|3.57|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 19F: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||3.57|2.08|
72457566|NCT00824850|144437706|SUPERIORITY_OR_OTHER||geometric mean fold rise|2.82|||||TWO_SIDED|95.0|2.08|3.83|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 23F: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||3.83|2.08|
72457567|NCT00824850|144437706|SUPERIORITY_OR_OTHER||geometric mean fold rise|3.79|||||TWO_SIDED|95.0|2.8|5.13|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 1: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||5.13|2.80|
72457568|NCT00824850|144437706|SUPERIORITY_OR_OTHER||geometric mean fold rise|1.32|||||TWO_SIDED|95.0|1.11|1.57|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 3: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||1.57|1.11|
72457569|NCT00824850|144437706|SUPERIORITY_OR_OTHER||geometric mean fold rise|1.3|||||TWO_SIDED|95.0|1.05|1.61|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 5: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||1.61|1.05|
72457570|NCT00824850|144437706|SUPERIORITY_OR_OTHER||geometric mean fold rise|2.04|||||TWO_SIDED|95.0|1.51|2.75|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 6A: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||2.75|1.51|
72370454|NCT00488683|144251632|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|-0.26||||0.46||95.0|||||Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccination and memory B cells one month after booster vaccination for the serogroup A||||0.46
72500325|NCT03193866|144530964|SUPERIORITY||Mean Difference (Net)|2.3|||||TWO_SIDED|95.0|-2.2|6.8||||||Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||6.8|-2.2|
72457571|NCT00824850|144437706|SUPERIORITY_OR_OTHER||geometric mean fold rise|2.87|||||TWO_SIDED|95.0|2.19|3.77|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 7F: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||3.77|2.19|
72457572|NCT00824850|144437706|SUPERIORITY_OR_OTHER||geometric mean fold rise|1.95|||||TWO_SIDED|95.0|1.59|2.39|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 19A: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||2.39|1.59|
72457573|NCT00824850|144437707|SUPERIORITY_OR_OTHER||geometric mean fold rise|201.8|||||TWO_SIDED|95.0|55.11|739.05|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 4: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||739.05|55.11|
72457574|NCT00824850|144437707|SUPERIORITY_OR_OTHER||geometric mean fold rise|11.7|||||TWO_SIDED|95.0|5.2|26.1|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 6B: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||26.10|5.20|
72457575|NCT00824850|144437707|SUPERIORITY_OR_OTHER||geometric mean fold rise|156.4|||||TWO_SIDED|95.0|48.72|501.86|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 9V: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||501.86|48.72|
72457576|NCT00824850|144437707|SUPERIORITY_OR_OTHER||geometric mean fold rise|37.4|||||TWO_SIDED|95.0|13.71|102.31|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 14: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||102.31|13.71|
72457577|NCT00824850|144437707|SUPERIORITY_OR_OTHER||geometric mean fold rise|93.9|||||TWO_SIDED|95.0|30.99|284.31|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 18C: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||284.31|30.99|
72457578|NCT00824850|144437707|SUPERIORITY_OR_OTHER||geometric mean fold rise|48.7|||||TWO_SIDED|95.0|23.27|101.97|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 19F: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||101.97|23.27|
72457579|NCT00824850|144437707|SUPERIORITY_OR_OTHER||geometric mean fold rise|32.1|||||TWO_SIDED|95.0|11.99|85.81|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 23F: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||85.81|11.99|
72457580|NCT00824850|144437707|SUPERIORITY_OR_OTHER||geometric mean fold rise|78.1|||||TWO_SIDED|95.0|50.42|120.94|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 1: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||120.94|50.42|
72457581|NCT00824850|144437707|SUPERIORITY_OR_OTHER||geometric mean fold rise|10.3|||||TWO_SIDED|95.0|6.8|15.72|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 3: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||15.72|6.80|
72563025|NCT00292227|144658103|NON_INFERIORITY_OR_EQUIVALENCE|A standard deviation of 12ms was assumed for sample size calculation. Sample size was calculated to have 90% power to show the non-inferiority of rotigotine against placebo with respect to the non-inferiority margin of 10ms (α=0.05, 1-sided).|Mean Difference (Net)|-0.42||||||90.0|-2.33|1.5|||ANCOVA|The ANCOVA model included the factors site, treatment, gender, and time-matched baseline QTcI as covariate.|The direction of the estimate is Rotigotine - Placebo. Mean difference was estimated from the ANCOVA model.|The analysis was based on a non-inferiority comparison of rotigotine vs placebo using a 1-sided 95% confidence interval (or, equivalently, the upper limit of 2-sided 90% confidence interval) for the time-matched changes from Baseline in QTcI.||1.50|-2.33|
72457582|NCT00824850|144437707|SUPERIORITY_OR_OTHER||geometric mean fold rise|61.7|||||TWO_SIDED|95.0|32.75|116.34|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 5: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||116.34|32.75|
72457583|NCT00824850|144437707|SUPERIORITY_OR_OTHER||geometric mean fold rise|536.5|||||TWO_SIDED|95.0|212.04|1357.19|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 6A: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||1357.19|212.04|
72392396|NCT04518293|144292242|OTHER|The difference between GMRx2 and dual-AI at Week 6 was estimated using MMRM.|LS Means Difference|-5.09|STANDARD_ERROR_OF_MEAN|0.603|<|0.0001|TWO_SIDED|95.0|-6.274|-3.912|||Mixed Models Analysis|||The LSM difference (95% CI) in home SBP reduction was calculated between GMRx2 and dual-AI arms.||-3.912|-6.274|<.0001
72457584|NCT00824850|144437707|SUPERIORITY_OR_OTHER||geometric mean fold rise|116.9|||||TWO_SIDED|95.0|33.28|410.33|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 7F: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||410.33|33.28|
72457585|NCT00824850|144437707|SUPERIORITY_OR_OTHER||geometric mean fold rise|24.6|||||TWO_SIDED|95.0|11.3|53.42|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 19A: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||53.42|11.30|
72457586|NCT00824850|144437708|SUPERIORITY_OR_OTHER||geometric mean fold rise|168.8|||||TWO_SIDED|95.0|20.22|1409.76|||||CI for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 4: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||1409.76|20.22|
72457587|NCT00824850|144437708|SUPERIORITY_OR_OTHER||geometric mean fold rise|40.3|||||TWO_SIDED|95.0|10.97|148.44|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 6B: GMRFs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||148.44|10.97|
72457588|NCT00824850|144437708|SUPERIORITY_OR_OTHER||geometric mean fold rise|61.9|||||TWO_SIDED|95.0|18.83|203.72|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 9V: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||203.72|18.83|
72457589|NCT00824850|144437708|SUPERIORITY_OR_OTHER||geometric mean fold rise|26.7|||||TWO_SIDED|95.0|9.67|73.84|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 14: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||73.84|9.67|
72457590|NCT00824850|144437708|SUPERIORITY_OR_OTHER||geometric mean fold rise|226.9|||||TWO_SIDED|95.0|79.81|645.29|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 18C: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||645.29|79.81|
72500326|NCT03193866|144530964|SUPERIORITY||Mean Difference (Net)|-8.3|||||TWO_SIDED|95.0|-20.3|3.7||||||Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||3.7|-20.3|
72457591|NCT00824850|144437708|SUPERIORITY_OR_OTHER||geometric mean fold rise|116.8|||||TWO_SIDED|95.0|54.54|250.13|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 19F: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||250.13|54.54|
72457592|NCT00824850|144437708|SUPERIORITY_OR_OTHER||geometric mean fold rise|481.0|||||TWO_SIDED|95.0|207.01|1117.69|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 23F: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||1117.69|207.01|
72457593|NCT00824850|144437708|SUPERIORITY_OR_OTHER||geometric mean fold rise|66.5|||||TWO_SIDED|95.0|41.8|105.75|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 1: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||105.75|41.80|
72457594|NCT00824850|144437708|SUPERIORITY_OR_OTHER||geometric mean fold rise|8.6|||||TWO_SIDED|95.0|5.36|13.94|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 3: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||13.94|5.36|
72457595|NCT00824850|144437708|SUPERIORITY_OR_OTHER||geometric mean fold rise|78.2|||||TWO_SIDED|95.0|41.38|147.8|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 5: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||147.80|41.38|
72392397|NCT04518293|144292243|OTHER|The difference between GMRx2 and dual-TA at Week 12 was estimated using MMRM.|LS Means Difference|-3.35|STANDARD_ERROR_OF_MEAN|0.364|<|0.0001|TWO_SIDED|95.0|-4.069|-2.632|||Mixed Models Analysis|||The LSM difference (95% CI) in home DBP reduction was calculated between GMRx2 and dual-TA arms.||-2.632|-4.069|<.0001
72370455|NCT00488683|144251632|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|-0.14||||0.59||95.0|||||Parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Pearson correlation coefficient between memory B cells one month after primary vaccination and memory B cells one month after booster vaccination for the serogroup A||||0.59
72457596|NCT00824850|144437708|SUPERIORITY_OR_OTHER||geometric mean fold rise|438.1|||||TWO_SIDED|95.0|169.52|1132.43|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 6A: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||1132.43|169.52|
72370456|NCT00488683|144251632|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|0.006||||0.98||95.0|||||Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccination and memory B cells one month after booster vaccination for the serogroup C||||0.98
72370457|NCT00488683|144251632|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|0.24||||0.2||95.0|||||Parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Pearson correlation coefficient between memory B cells one month after primary vaccination and memory B cells one month after booster vaccination for the serogroup C||||0.20
72370458|NCT00488683|144251632|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|0.43||||0.08||95.0|||||Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccination and memory B cells one month after booster vaccination for the serogroup W-135||||0.08
72370459|NCT00488683|144251632|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|-0.08||||0.68||95.0|||||Parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Pearson correlation coefficient between memory B cells one month after primary vaccination and memory B cells one month after booster vaccination for the serogroup W-135||||0.68
72370460|NCT00488683|144251632|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|0.77||||0.006||95.0|||||Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccination and memory B cells one month after booster vaccination for the serogroup Y||||0.006
72370461|NCT00488683|144251632|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|0.16||||0.48||95.0|||||Parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Pearson correlation coefficient between memory B cells one month after primary vaccination and memory B cells one month after booster vaccination for the serogroup Y||||0.48
72370462|NCT00488683|144251632|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|-0.26||||0.46||95.0|||||Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccination and memory B cells one month after booster vaccination for the serogroup A||||0.46
72370463|NCT00488683|144251632|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|-0.21||||0.4||95.0|||||Non-parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Spearman correlation coefficient between memory B cells one month after primary vaccination and memory B cells one month after booster vaccination for the serogroup A||||0.40
72457597|NCT00824850|144437708|SUPERIORITY_OR_OTHER||geometric mean fold rise|80.0|||||TWO_SIDED|95.0|23.28|274.82|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 7F: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||274.82|23.28|
72457598|NCT00824850|144437708|SUPERIORITY_OR_OTHER||geometric mean fold rise|61.5|||||TWO_SIDED|95.0|28.73|131.76|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 19A: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||131.76|28.73|
72457599|NCT00824850|144437709|SUPERIORITY_OR_OTHER||geometric mean fold rise|281.7|||||TWO_SIDED|95.0|76.65|1035.49|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 4: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||1035.49|76.65|
72457600|NCT00824850|144437709|SUPERIORITY_OR_OTHER||geometric mean fold rise|7.6|||||TWO_SIDED|95.0|3.47|16.75|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 6B: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||16.75|3.47|
72457601|NCT00824850|144437709|SUPERIORITY_OR_OTHER||geometric mean fold rise|151.4|||||TWO_SIDED|95.0|42.01|545.84|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 9V: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||545.84|42.01|
72457602|NCT00824850|144437709|SUPERIORITY_OR_OTHER||geometric mean fold rise|23.7|||||TWO_SIDED|95.0|8.67|64.54|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 14: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||64.54|8.67|
72457603|NCT00824850|144437709|SUPERIORITY_OR_OTHER||geometric mean fold rise|102.1|||||TWO_SIDED|95.0|32.0|325.4|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 18C: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||325.40|32.00|
72370464|NCT00488683|144251632|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.12||||0.6||95.0|||||Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccination and memory B cells one month after booster vaccination for the serogroup C||||0.60
72620825|NCT01887600|144772758|SUPERIORITY||Least squares mean difference|1.827|||<|0.001|TWO_SIDED|95.0|1.64|2.02||LSM Difference p-value is for test of differences.|Mixed Models Analysis|||Hb change from BL to week 6. A Mixed Model of Repeated Measures was applied using the visits up to Week 104. The results were based on the estimated difference between the two treatment arms by visit. The model included treatment arm, region, CV history, visits and visit by treatment as categorical variables and baseline Hb and baseline eGFR as continuous variables.||2.02|1.64|<0.001
72370465|NCT00488683|144251632|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.4||||0.03||95.0|||||Non-parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Spearman correlation coefficient between memory B cells one month after primary vaccination and memory B cells one month after booster vaccination for the serogroup C||||0.03
72370466|NCT00488683|144251632|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.72||||0.001||95.0|||||Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccination and memory B cells one month after booster vaccination for the serogroup W-135||||0.001
72620826|NCT01887600|144772758|SUPERIORITY||Least squares mean difference|2.058|||<|0.001|TWO_SIDED|95.0|1.87|2.25||LSM Difference p-value is for test of differences.|Mixed Models Analysis|||Hb change from BL to week 8. A Mixed Model of Repeated Measures was applied using the visits up to Week 104. The results were based on the estimated difference between the two treatment arms by visit. The model included treatment arm, region, CV history, visits and visit by treatment as categorical variables and baseline Hb and baseline eGFR as continuous variables.||2.25|1.87|<0.001
72370467|NCT00488683|144251632|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.0||||1||95.0|||||Non-parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Spearman correlation coefficient between memory B cells one month after primary vaccination and memory B cells one month after booster vaccination for the serogroup W-135||||1.00
72370468|NCT00488683|144251632|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.39||||0.24||95.0|||||Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccination and memory B cells one month after booster vaccination for the serogroup Y||||0.24
72370469|NCT00488683|144251632|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.22||||0.34||95.0|||||Non-parametric correlation||Values from Group 2 and 3 were combined for the analysis.|Spearman correlation coefficient between memory B cells one month after primary vaccination and memory B cells one month after booster vaccination for the serogroup Y||||0.34
72370470|NCT00488683|144251632|SUPERIORITY_OR_OTHER||R-square|0.07||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and memory B cells one month after booster vaccination for the serogroup A||||
72370471|NCT00488683|144251632|SUPERIORITY_OR_OTHER||R-square|0.02||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between memory B cells one month after primary vaccination and memory B cells one month after booster vaccination for the serogroup A||||
72370472|NCT00488683|144251632|SUPERIORITY_OR_OTHER||R-square|0.0||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and memory B cells one month after booster vaccination for the serogroup C||||
72370473|NCT00488683|144251632|SUPERIORITY_OR_OTHER||R-square|0.06||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between memory B cells one month after primary vaccination and memory B cells one month after booster vaccination for the serogroup C||||
72370474|NCT00488683|144251632|SUPERIORITY_OR_OTHER||R-square|0.19||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and memory B cells one month after booster vaccination for the serogroup W-135||||
72370475|NCT00488683|144251632|SUPERIORITY_OR_OTHER||R-square|0.007||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between memory B cells one month after primary vaccination and memory B cells one month after booster vaccination for the serogroup W-135||||
72370476|NCT00488683|144251632|SUPERIORITY_OR_OTHER||R-square|0.59||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and memory B cells one month after booster vaccination for the serogroup Y||||
72370477|NCT00488683|144251632|SUPERIORITY_OR_OTHER||R-square|0.03||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between memory B cells one month after primary vaccination and memory B cells one month after booster vaccination for the serogroup Y||||
72370478|NCT00488683|144251632|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|0.77||||0.0002||95.0|||||Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccination and hSBA titers one month after booster vaccination for the serogroup A||||0.0002
72370479|NCT00488683|144251632|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|0.03||||0.9||95.0|||||Parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Pearson correlation coefficient between memory B cells one month after primary vaccination and hSBA titers one month after booster vaccination for the serogroup A||||0.90
72370480|NCT00488683|144251632|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|0.47||||0.02||95.0|||||Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccination and hSBA titers one month after booster vaccination for the serogroup C||||0.02
72370481|NCT00488683|144251632|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|0.29||||0.12||95.0|||||Parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Pearson correlation coefficient between memory B cells one month after primary vaccination and hSBA titers one month after booster vaccination for the serogroup C||||0.12
72370482|NCT00488683|144251632|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|0.31||||0.22||95.0|||||Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccination and hSBA titers one month after booster vaccination for the serogroup W-135||||0.22
72370483|NCT00488683|144251632|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|0.81|||<|0.0001||95.0|||||Parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Pearson correlation coefficient between memory B cells one month after primary vaccination and hSBA titers one month after booster vaccination for the serogroup W-135||||<0.0001
72370484|NCT00488683|144251632|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|0.15||||0.82||95.0|||||Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccination and hSBA titers one month after booster vaccination for the serogroup Y||||0.82
72457604|NCT00824850|144437709|SUPERIORITY_OR_OTHER||geometric mean fold rise|31.1|||||TWO_SIDED|95.0|12.71|76.13|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 19F: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||76.13|12.71|
72563026|NCT00292227|144658104|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.34||||||95.0|-1.04|1.71|||ANOVA|The ANOVA model included the factors treatment, period, sequence, and subject(sequence).|The direction of the estimate is Moxifloxacin - Placebo. Mean difference was estimated from the ANOVA model.|For the analysis of the assay sensitivity, an ANOVA with the factors treatment, period, sequence, and subject(sequence) for comparison of moxifloxacin vs placebo (cross-over comparison) was performed. The point estimates for the difference between placebo and positive control (moxifloxacin) and the respective 95% confidence intervals were calculated.||1.71|-1.04|
72392398|NCT04518293|144292243|OTHER|The difference between GMRx2 and dual-TI at Week 12 was estimated using MMRM.|LS Means Difference|-2.1|STANDARD_ERROR_OF_MEAN|0.456|<|0.0001|TWO_SIDED|95.0|-2.998|-1.2|||Mixed Models Analysis|||The LSM difference (95% CI) in home DBP reduction was calculated between GMRx2 and dual-TI arms.||-1.200|-2.998|<.0001
72392399|NCT04518293|144292243|OTHER|The difference between GMRx2 and dual-AI at Week 12 was estimated using MMRM.|LS Means Difference|-3.63|STANDARD_ERROR_OF_MEAN|0.499|<|0.0001|TWO_SIDED|95.0|-4.617|-2.649|||Mixed Models Analysis|||The LSM difference (95% CI) in home DBP reduction was calculated between GMRx2 and dual-AI arms.||-2.649|-4.617|<.0001
72392400|NCT04518293|144292244|OTHER|The difference between GMRx2 and dual-TA at Week 6 was estimated using MMRM.|LS Means Difference|-3.52|STANDARD_ERROR_OF_MEAN|0.311|<|0.0001|TWO_SIDED|95.0|-4.137|-2.908|||Mixed Models Analysis|||The LSM difference (95% CI) in home DBP reduction was calculated between GMRx2 and dual-TA arms.||-2.908|-4.137|<.0001
72392401|NCT04518293|144292244|OTHER|The difference between GMRx2 and dual-TI at Week 6 was estimated using MMRM.|LS Means Difference|-2.09|STANDARD_ERROR_OF_MEAN|0.361|<|0.0001|TWO_SIDED|95.0|-2.803|-1.376|||Mixed Models Analysis|||The LSM difference (95% CI) in home DBP reduction was calculated between GMRx2 and dual-TI arms.||-1.376|-2.803|<.0001
72392402|NCT04518293|144292244|OTHER|The difference between GMRx2 and dual-AI at Week 6 was estimated using MMRM.|LS Means Difference|-3.58|STANDARD_ERROR_OF_MEAN|0.439|<|0.0001|TWO_SIDED|95.0|-4.446|-2.713|||Mixed Models Analysis|||The LSM difference (95% CI) in home DBP reduction was calculated between GMRx2 and dual-AI arms.||-2.713|-4.446|<.0001
72392403|NCT04518293|144292245|OTHER|The difference between GMRx2 and dual-TA at Week 12 was estimated using MMRM.|LS Means Difference|-5.58|STANDARD_ERROR_OF_MEAN|0.713|<|0.0001|TWO_SIDED|95.0|-6.983|-4.169|||Mixed Models Analysis|||The LSM difference (95% CI) in trough (i.e. before morning dose) home SBP reduction was calculated between GMRx2 and dual-TA arms.||-4.169|-6.983|<.0001
72392404|NCT04518293|144292245|OTHER|The difference between GMRx2 and dual-TI at Week 12 was estimated using MMRM.|LS Means Difference|-1.91|STANDARD_ERROR_OF_MEAN|0.662||0.0043|TWO_SIDED|95.0|-3.218|-0.607|||Mixed Models Analysis|||The LSM difference (95% CI) in trough (i.e. before morning dose) home SBP reduction was calculated between GMRx2 and dual-TI arms.||-0.607|-3.218|0.0043
72392405|NCT04518293|144292245|OTHER|The difference between GMRx2 and dual-AI at Week 12 was estimated using MMRM.|LS Means Difference|-3.74|STANDARD_ERROR_OF_MEAN|0.745|<|0.0001|TWO_SIDED|95.0|-5.214|-2.274|||Mixed Models Analysis|||The LSM difference (95% CI) in trough (i.e. before morning dose) home SBP reduction was calculated between GMRx2 and dual-AI arms.||-2.274|-5.214|<.0001
72392406|NCT04518293|144292246|OTHER|The difference between GMRx2 and dual-TA at Week 6 was estimated using MMRM.|LS Means Difference|-6.25|STANDARD_ERROR_OF_MEAN|0.546|<|0.0001|TWO_SIDED|95.0|-7.324|-5.168|||Mixed Models Analysis|||The LSM difference (95% CI) in trough (i.e. before morning dose) home SBP reduction was calculated between GMRx2 and dual-TA arms.||-5.168|-7.324|<.0001
72392407|NCT04518293|144292246|OTHER|The difference between GMRx2 and dual-TI at Week 6 was estimated using MMRM.|LS Means Difference|-2.72|STANDARD_ERROR_OF_MEAN|0.616|<|0.0001|TWO_SIDED|95.0|-3.941|-1.507|||Mixed Models Analysis|||The LSM difference (95% CI) in trough (i.e. before morning dose) home SBP reduction was calculated between GMRx2 and dual-TI arms.||-1.507|-3.941|<.0001
72392408|NCT04518293|144292246|OTHER|The difference between GMRx2 and dual-AI at Week 6 was estimated using MMRM.|LS Means Difference|-4.43|STANDARD_ERROR_OF_MEAN|0.537|<|0.0001|TWO_SIDED|95.0|-5.489|-3.368|||Mixed Models Analysis|||The LSM difference (95% CI) in trough (i.e. before morning dose) home SBP reduction was calculated between GMRx2 and dual-AI arms.||-3.368|-5.489|<.0001
72392409|NCT04518293|144292247|OTHER||Risk Difference (RD)|14.79|||<|0.0001|TWO_SIDED|95.0|7.749|21.824|||Wald test|||The difference between GMRx2 and TA at Week 12 was estimated using Generalized Estimating Equation.||21.824|7.749|<.0001
72392410|NCT04518293|144292247|OTHER||Risk Difference (RD)|8.46||||0.0146|TWO_SIDED|95.0|1.58|15.501|||Wald test|||The difference between GMRx2 and TI at Week 12 was estimated using Generalized Estimating Equation.||15.501|1.580|0.0146
72370485|NCT00488683|144251632|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|-0.15||||0.66||95.0|||||Parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Pearson correlation coefficient between memory B cells one month after primary vaccination and hSBA titers one month after booster vaccination for the serogroup Y||||0.66
72392411|NCT04518293|144292247|OTHER||Risk Difference (RD)|16.07|||<|0.0001|TWO_SIDED|95.0|8.953|23.171|||Wald test|||The difference between GMRx2 and AI at Week 12 was estimated using Generalized Estimating Equation.||23.171|8.953|<.0001
72392412|NCT04518293|144292248|OTHER||Risk Difference (RD)|18.11|||<|0.0001|TWO_SIDED|95.0|10.778|25.226|||Wald test|||The difference between GMRx2 and TA at Week 6 was estimated using Generalized Estimating Equation.||25.226|10.778|<.0001
72392413|NCT04518293|144292248|OTHER||Risk Difference (RD)|6.64||||0.0674|TWO_SIDED|95.0|-0.613|13.926|||Wald test|||The difference between GMRx2 and TI at Week 12 was estimated using Generalized Estimating Equation.||13.926|-0.613|0.0674
72392414|NCT04518293|144292248|OTHER||Risk Difference (RD)|18.23|||<|0.0001|TWO_SIDED|95.0|10.839|25.392|||Wald test|||The difference between GMRx2 and AI at Week 12 was estimated using Generalized Estimating Equation.||25.392|10.839|<.0001
72392415|NCT04518293|144292249|OTHER||Risk Difference (RD)|17.25|||<|0.0001|TWO_SIDED|95.0|9.902|24.286|||Wald test|||The difference between GMRx2 and TA at Week 12 was estimated using Generalized Estimating Equation.||24.286|9.902|<.0001
72370486|NCT00488683|144251632|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.51||||0.03||95.0|||||Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccination and hSBA titers one month after booster vaccination for the serogroup A||||0.03
72370487|NCT00488683|144251632|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.14||||0.53||95.0|||||Non-parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Spearman correlation coefficient between memory B cells one month after primary vaccination and hSBA titers one month after booster vaccination for the serogroup A||||0.53
72457605|NCT00824850|144437709|SUPERIORITY_OR_OTHER||geometric mean fold rise|18.7|||||TWO_SIDED|95.0|6.82|51.39|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 23F: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||51.39|6.82|
72457606|NCT00824850|144437709|SUPERIORITY_OR_OTHER||geometric mean fold rise|64.4|||||TWO_SIDED|95.0|37.33|111.18|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 1: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||111.18|37.33|
72457607|NCT00824850|144437709|SUPERIORITY_OR_OTHER||geometric mean fold rise|11.1|||||TWO_SIDED|95.0|6.64|18.52|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 3: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||18.52|6.64|
72457608|NCT00824850|144437709|SUPERIORITY_OR_OTHER||geometric mean fold rise|41.2|||||TWO_SIDED|95.0|23.09|73.48|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 5: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||73.48|23.09|
72457609|NCT00824850|144437709|SUPERIORITY_OR_OTHER||geometric mean fold rise|479.6|||||TWO_SIDED|95.0|171.63|1339.96|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 6A: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||1339.96|171.63|
72457610|NCT00824850|144437709|SUPERIORITY_OR_OTHER||geometric mean fold rise|76.4|||||TWO_SIDED|95.0|21.63|270.02|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 7F: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||270.02|21.63|
72457611|NCT00824850|144437709|SUPERIORITY_OR_OTHER||geometric mean fold rise|17.7|||||TWO_SIDED|95.0|7.61|41.08|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 19A: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||41.08|7.61|
72457612|NCT00824850|144437710|SUPERIORITY_OR_OTHER||geometric mean fold rise|170.2|||||TWO_SIDED|95.0|22.24|1301.79|||||CI for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 4: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||1301.79|22.24|
72457613|NCT00824850|144437710|SUPERIORITY_OR_OTHER||geometric mean fold rise|17.8|||||TWO_SIDED|95.0|5.27|59.91|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 6B: GMRFs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||59.91|5.27|
72457614|NCT00824850|144437710|SUPERIORITY_OR_OTHER||geometric mean fold rise|67.8|||||TWO_SIDED|95.0|18.45|249.02|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 9V: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||249.02|18.45|
72500327|NCT03193866|144530964|SUPERIORITY||Mean Difference (Net)|0.4|||||TWO_SIDED|95.0|-2.6|3.5||||||Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||3.5|-2.6|
72500328|NCT03193866|144530964|SUPERIORITY||Mean Difference (Net)|-2.4|||||TWO_SIDED|95.0|-5.8|0.9||||||Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||0.9|-5.8|
72500329|NCT03193866|144530964|SUPERIORITY||Mean Difference (Net)|-0.1|||||TWO_SIDED|95.0|-2.9|2.7||||||Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||2.7|-2.9|
72370488|NCT00488683|144251632|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.2||||0.35||95.0|||||Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccination and hSBA titers one month after booster vaccination for the serogroup C||||0.35
72370489|NCT00488683|144251632|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.47||||0.09||95.0|||||Non-parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Spearman correlation coefficient between memory B cells one month after primary vaccination and hSBA titers one month after booster vaccination for the serogroup C||||0.09
72457615|NCT00824850|144437710|SUPERIORITY_OR_OTHER||geometric mean fold rise|22.2|||||TWO_SIDED|95.0|7.94|61.88|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 14: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||61.88|7.94|
72620827|NCT01887600|144772758|SUPERIORITY||Least squares mean difference|1.949|||<|0.001|TWO_SIDED|95.0|1.75|2.14||LSM Difference p-value is for test of differences.|Mixed Models Analysis|||Hb change from BL to week 10. A Mixed Model of Repeated Measures was applied using the visits up to Week 104. The results were based on the estimated difference between the two treatment arms by visit. The model included treatment arm, region, CV history, visits and visit by treatment as categorical variables and baseline Hb and baseline eGFR as continuous variables.||2.14|1.75|<0.001
72392416|NCT04518293|144292249|OTHER||Risk Difference (RD)|12.06||||0.001|TWO_SIDED|95.0|4.632|19.293|||Wald test|||The difference between GMRx2 and TI at Week 12 was estimated using Generalized Estimating Equation.||19.293|4.632|0.0010
72392417|NCT04518293|144292249|OTHER||Risk Difference (RD)|22.93|||<|0.0001|TWO_SIDED|95.0|15.622|29.796|||Wald test|||The difference between GMRx2 and AI at Week 12 was estimated using Generalized Estimating Equation.||29.796|15.622|<.0001
72392418|NCT04518293|144292250|OTHER||Risk Difference (RD)|18.59|||<|0.0001|TWO_SIDED|95.0|11.579|25.124|||Wald test|||The difference between GMRx2 and TA at Week 6 was estimated using Generalized Estimating Equation.||25.124|11.579|<.0001
72392419|NCT04518293|144292250|OTHER||Risk Difference (RD)|12.22||||0.0005|TWO_SIDED|95.0|4.963|19.123|||Wald test|||The difference between GMRx2 and TI at Week 6 was estimated using Generalized Estimating Equation.||19.123|4.963|0.0005
72392420|NCT04518293|144292250|OTHER||Risk Difference (RD)|16.2|||<|0.0001|TWO_SIDED|95.0|9.06|22.914|||Wald test|||The difference between GMRx2 and AI at Week 6 was estimated using Generalized Estimating Equation.||22.914|9.060|<.0001
72392421|NCT04518293|144292251|OTHER|95% CI for risk difference utilized Newcombe estimation method.|Risk Difference (RD)|0.93|||||TWO_SIDED|95.0|-1.529|2.768||||||The Risk difference (95% CI) in percentage of participants discontinuing trial medication due to AE/SAE at Week 12 was calculated between GMRx2 and dual-TA arms.||2.768|-1.529|
72392422|NCT04518293|144292251|OTHER|95% CI for risk difference utilized Newcombe estimation method.|Risk Difference (RD)|0.55|||||TWO_SIDED|95.0|-2.098|2.475||||||The Risk difference (95% CI) in percentage of participants discontinuing trial medication due to AE/SAE at Week 12 was calculated between GMRx2 and dual-TI arms.||2.475|-2.098|
72392423|NCT04518293|144292251|OTHER|95% CI for risk difference utilized Newcombe estimation method.|Risk Difference (RD)|0.55|||||TWO_SIDED|95.0|-2.098|2.475||||||The Risk difference (95% CI) in percentage of participants discontinuing trial medication due to AE/SAE at Week 12 was calculated between GMRx2 and dual-AI arms.||2.475|-2.098|
72392424|NCT04518293|144292257|OTHER|95% CI for risk difference utilized Newcombe estimation method.|Risk Difference (RD)|4.07|||||TWO_SIDED|95.0|0.494|7.116||||||The Risk difference (95% CI) in percentage of participants with serum sodium concentration below 135 mmol/l at Week 12 was calculated between GMRx2 and dual-TA arms.||7.116|0.494|
72392425|NCT04518293|144292257|OTHER|95% CI for risk difference utilized Newcombe estimation method.|Risk Difference (RD)|0.38|||||TWO_SIDED|95.0|-3.927|4.02||||||The Risk difference (95% CI) in percentage of participants with serum sodium concentration below 135 mmol/l at Week 12 was calculated between GMRx2 and dual-TI arms.||4.020|-3.927|
72392426|NCT04518293|144292257|OTHER|95% CI for risk difference utilized Newcombe estimation method.|Risk Difference (RD)|3.64|||||TWO_SIDED|95.0|-0.07|6.764||||||The Risk difference (95% CI) in percentage of participants with serum sodium concentration below 135 mmol/l at Week 12 was calculated between GMRx2 and dual-AI arms.||6.764|-0.070|
72392427|NCT04518293|144292258|OTHER|95% CI for risk difference utilized Newcombe estimation method.|Risk Difference (RD)|2.59|||||TWO_SIDED|95.0|-0.5|5.136||||||The Risk difference (95% CI) in percentage of participants with serum sodium concentration below 135 mmol/l at Week 6 was calculated between GMRx2 and dual-TA arms.||5.136|-0.500|
72392428|NCT04518293|144292258|OTHER|95% CI for risk difference utilized Newcombe estimation method.|Risk Difference (RD)|1.82|||||TWO_SIDED|95.0|-1.513|4.517||||||The Risk difference (95% CI) in percentage of participants with serum sodium concentration below 135 mmol/l at Week 6 was calculated between GMRx2 and dual-TI arms.||4.517|-1.513|
72392429|NCT04518293|144292258|OTHER|95% CI for risk difference utilized Newcombe estimation method.|Risk Difference (RD)|0.73|||||TWO_SIDED|95.0|-2.855|3.633||||||The Risk difference (95% CI) in percentage of participants with serum sodium concentration below 135 mmol/l at Week 6 was calculated between GMRx2 and dual-AI arms.||3.633|-2.855|
72392430|NCT04518293|144292259|OTHER|95% CI for risk difference utilized Newcombe estimation method.|Risk Difference (RD)|-0.06|||||TWO_SIDED|95.0|-3.911|3.129||||||The Risk difference (95% CI) in percentage of participants with serum sodium concentration above 145 mmol/l at Week 12 was calculated between GMRx2 and dual-TA arms.||3.129|-3.911|
72392431|NCT04518293|144292259|OTHER|95% CI for risk difference utilized Newcombe estimation method.|Risk Difference (RD)|-0.53|||||TWO_SIDED|95.0|-4.519|2.744||||||The Risk difference (95% CI) in percentage of participants with serum sodium concentration above 145 mmol/l at Week 12 was calculated between GMRx2 and dual-TI arms.||2.744|-4.519|
72392432|NCT04518293|144292259|OTHER|95% CI for risk difference utilized Newcombe estimation method.|Risk Difference (RD)|0.55|||||TWO_SIDED|95.0|-3.228|3.647||||||The Risk difference (95% CI) in percentage of participants with serum sodium concentration above 145 mmol/l at Week 12 was calculated between GMRx2 and dual-AI arms.||3.647|-3.228|
72392433|NCT04518293|144292260|OTHER|95% CI for risk difference utilized Newcombe estimation method.|Risk Difference (RD)|-0.25|||||TWO_SIDED|95.0|-3.993|2.816||||||The Risk difference (95% CI) in percentage of participants with serum sodium concentration above 145 mmol/l at Week 6 was calculated between GMRx2 and dual-TA arms.||2.816|-3.993|
72392434|NCT04518293|144292260|OTHER|95% CI for risk difference utilized Newcombe estimation method.|Risk Difference (RD)|1.82|||||TWO_SIDED|95.0|-1.513|4.517||||||The Risk difference (95% CI) in percentage of participants with serum sodium concentration above 145 mmol/l at Week 6 was calculated between GMRx2 and dual-TI arms.||4.517|-1.513|
72457616|NCT00824850|144437710|SUPERIORITY_OR_OTHER||geometric mean fold rise|205.5|||||TWO_SIDED|95.0|70.04|602.78|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 18C: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||602.78|70.04|
72457617|NCT00824850|144437710|SUPERIORITY_OR_OTHER||geometric mean fold rise|90.5|||||TWO_SIDED|95.0|40.28|203.27|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 19F: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||203.27|40.28|
72457618|NCT00824850|144437710|SUPERIORITY_OR_OTHER||geometric mean fold rise|91.7|||||TWO_SIDED|95.0|36.25|232.13|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 23F: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||232.13|36.25|
72457619|NCT00824850|144437710|SUPERIORITY_OR_OTHER||geometric mean fold rise|75.6|||||TWO_SIDED|95.0|47.32|120.91|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 1: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||120.91|47.32|
72457620|NCT00824850|144437710|SUPERIORITY_OR_OTHER||geometric mean fold rise|8.7|||||TWO_SIDED|95.0|5.21|14.4|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 3: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||14.40|5.21|
72457621|NCT00824850|144437710|SUPERIORITY_OR_OTHER||geometric mean fold rise|60.0|||||TWO_SIDED|95.0|31.06|115.92|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 5: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||115.92|31.06|
72457622|NCT00824850|144437710|SUPERIORITY_OR_OTHER||geometric mean fold rise|269.8|||||TWO_SIDED|95.0|105.09|692.6|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 6A: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||692.60|105.09|
72457623|NCT00824850|144437710|SUPERIORITY_OR_OTHER||geometric mean fold rise|37.7|||||TWO_SIDED|95.0|10.85|131.09|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 7F: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||131.09|10.85|
72500330|NCT03193866|144530964|SUPERIORITY||Mean Difference (Net)|-1.5|||||TWO_SIDED|95.0|-4.5|1.6||||||Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||1.6|-4.5|
72500331|NCT03193866|144530964|SUPERIORITY||Mean Difference (Net)|-1.6|||||TWO_SIDED|95.0|-4.7|1.5||||||Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||1.5|-4.7|
72500332|NCT03193866|144530964|SUPERIORITY||Mean Difference (Net)|2.3|||||TWO_SIDED|95.0|-1.7|6.4||||||Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||6.4|-1.7|
72457624|NCT00824850|144437710|SUPERIORITY_OR_OTHER||geometric mean fold rise|44.8|||||TWO_SIDED|95.0|21.31|94.01|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 19A: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||94.01|21.31|
72457625|NCT00824850|144437711|SUPERIORITY_OR_OTHER||ratio of geometric mean concentrations|1.97|||||TWO_SIDED|95.0|1.31|2.95|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(7vPnC/13vPnC) - (MnCC/13vPnC)\].|7vPnC serotype 4: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).||2.95|1.31|
72500333|NCT03193866|144530965|SUPERIORITY||Difference in proportion|0.39|||||TWO_SIDED|95.0|0.3|0.48||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||0.48|0.30|
72457626|NCT00824850|144437711|SUPERIORITY_OR_OTHER||ratio of geometric mean concentrations|2.95|||||TWO_SIDED|95.0|1.78|4.9|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(7vPnC/13vPnC) - (MnCC/13vPnC)\].|7vPnC serotype 6B: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).||4.90|1.78|
72457627|NCT00824850|144437711|SUPERIORITY_OR_OTHER||ratio of geometric mean concentrations|1.85|||||TWO_SIDED|95.0|1.25|2.75|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(7vPnC/13vPnC) - (MnCC/13vPnC)\].|7vPnC serotype 9V: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).||2.75|1.25|
72457628|NCT00824850|144437711|SUPERIORITY_OR_OTHER||ratio of geometric mean concentrations|2.24|||||TWO_SIDED|95.0|1.11|4.53|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(7vPnC/13vPnC) - (MnCC/13vPnC)\].|7vPnC serotype 14: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).||4.53|1.11|
72457629|NCT00824850|144437711|SUPERIORITY_OR_OTHER||ratio of geometric mean concentrations|0.63|||||TWO_SIDED|95.0|0.38|1.05|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(7vPnC/13vPnC) - (MnCC/13vPnC)\].|7vPnC serotype 18C: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).||1.05|0.38|
72392435|NCT04518293|144292260|OTHER|95% CI for risk difference utilized Newcombe estimation method.|Risk Difference (RD)|-0.72|||||TWO_SIDED|95.0|-4.596|2.44||||||The Risk difference (95% CI) in percentage of participants with serum sodium concentration above 145 mmol/l at Week 6 was calculated between GMRx2 and dual-TI arms.||2.440|-4.596|
72392436|NCT04518293|144292261|OTHER|95% CI for risk difference utilized Newcombe estimation method.|Risk Difference (RD)|6.72|||||TWO_SIDED|95.0|4.196|9.222||||||The Risk difference (95% CI) in percentage of participants with serum potassium concentration below 3.5 mmol/l at Week 12 was calculated between GMRx2 and dual-TA arms.||9.222|4.196|
72392437|NCT04518293|144292261|OTHER|95% CI for risk difference utilized Newcombe estimation method.|Risk Difference (RD)|2.0|||||TWO_SIDED|95.0|-1.883|5.257||||||The Risk difference (95% CI) in percentage of participants with serum potassium concentration below 3.5 mmol/l at Week 12 was calculated between GMRx2 and dual-TI arms.||5.257|-1.883|
72392438|NCT04518293|144292261|OTHER|95% CI for risk difference utilized Newcombe estimation method.|Risk Difference (RD)|-5.97|||||TWO_SIDED|95.0|-10.979|-1.6||||||The Risk difference (95% CI) in percentage of participants with serum potassium concentration below 3.5 mmol/l at Week 12 was calculated between GMRx2 and dual-AI arms.||-1.600|-10.979|
72392439|NCT04518293|144292262|OTHER|95% CI for risk difference utilized Newcombe estimation method.|Risk Difference (RD)|3.13|||||TWO_SIDED|95.0|0.123|5.632||||||The Risk difference (95% CI) in percentage of participants with serum potassium concentration below 3.5 mmol/l at Week 6 was calculated between GMRx2 and dual-TA arms.||5.632|0.123|
72392440|NCT04518293|144292262|OTHER|95% CI for risk difference utilized Newcombe estimation method.|Risk Difference (RD)|1.28|||||TWO_SIDED|95.0|-2.245|4.134||||||The Risk difference (95% CI) in percentage of participants with serum potassium concentration below 3.5 mmol/l at Week 6 was calculated between GMRx2 and dual-TI arms.||4.134|-2.245|
72392441|NCT04518293|144292262|OTHER|95% CI for risk difference utilized Newcombe estimation method.|Risk Difference (RD)|-2.71|||||TWO_SIDED|95.0|-6.968|0.819||||||The Risk difference (95% CI) in percentage of participants with serum potassium concentration below 3.5 mmol/l at Week 6 was calculated between GMRx2 and dual-AI arms.||0.819|-6.968|
72392442|NCT04518293|144292263|OTHER|95% CI for risk difference utilized Newcombe estimation method.|Risk Difference (RD)|0.91|||||TWO_SIDED|95.0|-0.863|2.231||||||The Risk difference (95% CI) in percentage of participants with serum potassium concentration above 5.5 mmol/l at Week 12 was calculated between GMRx2 and dual-TA arms.||2.231|-0.863|
72392443|NCT04518293|144292263|OTHER||Risk Difference (RD)|0.91|||||TWO_SIDED|95.0|-0.897|2.231||||||The Risk difference (95% CI) in percentage of participants with serum potassium concentration above 5.5 mmol/l at Week 12 was calculated between GMRx2 and dual-TI arms.||2.231|-0.897|
72392444|NCT04518293|144292263|OTHER|95% CI for risk difference utilized Newcombe estimation method.|Risk Difference (RD)|0.55|||||TWO_SIDED|95.0|-1.494|1.913||||||The Risk difference (95% CI) in percentage of participants with serum potassium concentration above 5.5 mmol/l at Week 12 was calculated between GMRx2 and dual-AI arms.||1.913|-1.494|
72392445|NCT04518293|144292264|OTHER|95% CI for risk difference utilized Newcombe estimation method.|Risk Difference (RD)|0.01|||||TWO_SIDED|95.0|-1.931|1.149||||||The Risk difference (95% CI) in percentage of participants with serum potassium concentration above 5.5 mmol/l at Week 6 was calculated between GMRx2 and dual-TA arms.||1.149|-1.931|
72392446|NCT04518293|144292264|OTHER|95% CI for risk difference utilized Newcombe estimation method.|Risk Difference (RD)|0.0|||||TWO_SIDED|95.0|-1.979|1.143||||||The Risk difference (95% CI) in percentage of participants with serum potassium concentration above 5.5 mmol/l at Week 6 was calculated between GMRx2 and dual-TI arms.||1.143|-1.979|
72392447|NCT04518293|144292264|OTHER|95% CI for risk difference utilized Newcombe estimation method.|Risk Difference (RD)|0.36|||||TWO_SIDED|95.0|-1.374|1.453||||||The Risk difference (95% CI) in percentage of participants with serum potassium concentration above 5.5 mmol/l at Week 6 was calculated between GMRx2 and dual-AI arms.||1.453|-1.374|
72392448|NCT04518293|144292265|OTHER|95% CI for risk difference utilized Newcombe estimation method.|Risk Difference (RD)|0.39|||||TWO_SIDED|95.0|-2.014|2.087||||||The Risk difference (95% CI) in percentage of participants with eGFR drop of over 30% at Week 12 was calculated between GMRx2 and dual-TA arms.||2.087|-2.014|
72392449|NCT04518293|144292265|OTHER|95% CI for risk difference utilized Newcombe estimation method.|Risk Difference (RD)|1.09|||||TWO_SIDED|95.0|-1.015|2.633||||||The Risk difference (95% CI) in percentage of participants with eGFR drop of over 30% at Week 12 was calculated between GMRx2 and dual-TI arms.||2.633|-1.015|
72392450|NCT04518293|144292265|OTHER|95% CI for risk difference utilized Newcombe estimation method.|Risk Difference (RD)|1.09|||||TWO_SIDED|95.0|-1.015|2.633||||||The Risk difference (95% CI) in percentage of participants with eGFR drop of over 30% at Week 12 was calculated between GMRx2 and dual-AI arms.||2.633|-1.015|
72392451|NCT04518293|144292266|OTHER|95% CI for risk difference utilized Newcombe estimation method.|Risk Difference (RD)|-0.16|||||TWO_SIDED|95.0|-2.501|1.385||||||The Risk difference (95% CI) in percentage of participants with eGFR drop of over 30% at Week 6 was calculated between GMRx2 and dual-TA arms.||1.385|-2.501|
72457630|NCT00824850|144437711|SUPERIORITY_OR_OTHER||ratio of geometric mean concentrations|0.9|||||TWO_SIDED|95.0|0.5|1.62|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(7vPnC/13vPnC) - (MnCC/13vPnC)\].|7vPnC serotype 19F: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).||1.62|0.50|
72457631|NCT00824850|144437711|SUPERIORITY_OR_OTHER||ratio of geometric mean concentrations|0.83|||||TWO_SIDED|95.0|0.48|1.43|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(7vPnC/13vPnC) - (MnCC/13vPnC)\].|7vPnC serotype 23F: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).||1.43|0.48|
72500334|NCT03193866|144530965|SUPERIORITY||Difference in proportion|0.27|||||TWO_SIDED|95.0|0.11|0.42||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||0.42|0.11|
72500335|NCT03193866|144530965|SUPERIORITY||Difference in proportion|0.17|||||TWO_SIDED|95.0|0.1|0.23||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||0.23|0.10|
72500336|NCT03193866|144530965|SUPERIORITY||Difference in proportion|0.05|||||TWO_SIDED|95.0|-0.03|0.13||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||0.13|-0.03|
72500337|NCT03193866|144530965|SUPERIORITY||Difference in proportion|0.14|||||TWO_SIDED|95.0|0.08|0.19||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||0.19|0.08|
72500338|NCT03193866|144530965|SUPERIORITY||Difference in proportion|0.09|||||TWO_SIDED|95.0|0.01|0.16||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||0.16|0.01|
72500339|NCT03193866|144530965|SUPERIORITY||Difference in proportion|0.14|||||TWO_SIDED|95.0|0.06|0.21||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||0.21|0.06|
72457632|NCT00824850|144437711|SUPERIORITY_OR_OTHER||ratio of geometric mean concentrations|1.7|||||TWO_SIDED|95.0|0.96|3.0|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(7vPnC/13vPnC) - (MnCC/13vPnC)\].|Additional serotype 1: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).||3.00|0.96|
72457633|NCT00824850|144437711|SUPERIORITY_OR_OTHER||ratio of geometric mean concentrations|1.25|||||TWO_SIDED|95.0|0.79|1.96|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(7vPnC/13vPnC) - (MnCC/13vPnC)\].|Additional serotype 3: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).||1.96|0.79|
72620828|NCT01887600|144772758|SUPERIORITY||Least squares mean difference|2.09|||<|0.001|TWO_SIDED|95.0|1.9|2.28||LSM Difference p-value is for test of differences.|Mixed Models Analysis|||Hb change from BL to week 12. A Mixed Model of Repeated Measures was applied using the visits up to Week 104. The results were based on the estimated difference between the two treatment arms by visit.The model included treatment arm, region, CV history, visits and visit by treatment as categorical variables and baseline Hb and baseline eGFR as continuous variables.||2.28|1.90|<0.001
72457634|NCT00824850|144437711|SUPERIORITY_OR_OTHER||ratio of geometric mean concentrations|0.9|||||TWO_SIDED|95.0|0.54|1.52|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(7vPnC/13vPnC) - (MnCC/13vPnC)\].|Additional serotype 5: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).||1.52|0.54|
72500340|NCT03193866|144530965|SUPERIORITY||Difference in proportion|0.23|||||TWO_SIDED|95.0|0.13|0.33||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||0.33|0.13|
72500341|NCT03193866|144530966|SUPERIORITY||Difference in proportion|-71.6|||||TWO_SIDED|95.0|-76.6|-66.6||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||-66.6|-76.6|
72457635|NCT00824850|144437711|SUPERIORITY_OR_OTHER||ratio of geometric mean concentrations|1.81|||||TWO_SIDED|95.0|0.98|3.34|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(7vPnC/13vPnC) - (MnCC/13vPnC)\].|Additional serotype 6A: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).||3.34|0.98|
72457636|NCT00824850|144437711|SUPERIORITY_OR_OTHER||ratio of geometric mean concentrations|1.72|||||TWO_SIDED|95.0|1.05|2.83|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(7vPnC/13vPnC) - (MnCC/13vPnC)\].|Additional serotype 7F: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).||2.83|1.05|
72457637|NCT00824850|144437711|SUPERIORITY_OR_OTHER||ratio of geometric mean concentrations|1.06|||||TWO_SIDED|95.0|0.67|1.66|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(7vPnC/13vPnC) - (MnCC/13vPnC)\].|Additional serotype 19A: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).||1.66|0.67|
72457638|NCT00824850|144437712|SUPERIORITY_OR_OTHER||ratio of geometric mean concentrations|2.18|||||TWO_SIDED|95.0|1.26|3.79|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(7vPnC/13vPnC) - (MnCC/13vPnC)\].|7vPnC serotype 4: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).||3.79|1.26|
72457639|NCT00824850|144437712|SUPERIORITY_OR_OTHER||ratio of geometric mean concentrations|3.13|||||TWO_SIDED|95.0|1.84|5.32|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(7vPnC/13vPnC) - (MnCC/13vPnC)\].|7vPnC serotype 6B: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).||5.32|1.84|
72457640|NCT00824850|144437712|SUPERIORITY_OR_OTHER||ratio of geometric mean concentrations|1.68|||||TWO_SIDED|95.0|1.13|2.51|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(7vPnC/13vPnC) - (MnCC/13vPnC)\].|7vPnC serotype 9V: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).||2.51|1.13|
72457641|NCT00824850|144437712|SUPERIORITY_OR_OTHER||ratio of geometric mean concentrations|1.96|||||TWO_SIDED|95.0|0.95|4.07|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(7vPnC/13vPnC) - (MnCC/13vPnC)\].|7vPnC serotype 14: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).||4.07|0.95|
72457642|NCT00824850|144437712|SUPERIORITY_OR_OTHER||ratio of geometric mean concentrations|0.9|||||TWO_SIDED|95.0|0.51|1.56|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(7vPnC/13vPnC) - (MnCC/13vPnC)\].|7vPnC serotype 18C: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).||1.56|0.51|
72457643|NCT00824850|144437712|SUPERIORITY_OR_OTHER||ratio of geometric mean concentrations|1.58|||||TWO_SIDED|95.0|0.93|2.66|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(7vPnC/13vPnC) - (MnCC/13vPnC)\].|7vPnC serotype 19F: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).||2.66|0.93|
72457644|NCT00824850|144437712|SUPERIORITY_OR_OTHER||ratio of geometric mean concentrations|1.62|||||TWO_SIDED|95.0|0.97|2.73|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(7vPnC/13vPnC) - (MnCC/13vPnC)\].|7vPnC serotype 23F: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).||2.73|0.97|
72457645|NCT00824850|144437712|SUPERIORITY_OR_OTHER||ratio of geometric mean concentrations|1.41|||||TWO_SIDED|95.0|0.83|2.39|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(7vPnC/13vPnC) - (MnCC/13vPnC)\].|Additional serotype 1: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).||2.39|0.83|
72457646|NCT00824850|144437712|SUPERIORITY_OR_OTHER||ratio of geometric mean concentrations|1.44|||||TWO_SIDED|95.0|0.89|2.34|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(7vPnC/13vPnC) - (MnCC/13vPnC)\].|Additional serotype 3: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).||2.34|0.89|
72457647|NCT00824850|144437712|SUPERIORITY_OR_OTHER||ratio of geometric mean concentrations|1.06|||||TWO_SIDED|95.0|0.68|1.64|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(7vPnC/13vPnC) - (MnCC/13vPnC)\].|Additional serotype 5: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).||1.64|0.68|
72500342|NCT03193866|144530966|SUPERIORITY||Difference in proportion|-66.3|||||TWO_SIDED|95.0|-76.3|-56.4||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||-56.4|-76.3|
72457648|NCT00824850|144437712|SUPERIORITY_OR_OTHER||ratio of geometric mean concentrations|1.88|||||TWO_SIDED|95.0|1.05|3.35|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(7vPnC/13vPnC) - (MnCC/13vPnC)\].|7vPnC serotype 6A: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).||3.35|1.05|
72457649|NCT00824850|144437712|SUPERIORITY_OR_OTHER||ratio of geometric mean concentrations|1.48|||||TWO_SIDED|95.0|0.9|2.44|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(7vPnC/13vPnC) - (MnCC/13vPnC)\].|Additional serotype 7F: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).||2.44|0.90|
72457650|NCT00824850|144437712|SUPERIORITY_OR_OTHER||ratio of geometric mean concentrations|1.11|||||TWO_SIDED|95.0|0.75|1.66|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(7vPnC/13vPnC) - (MnCC/13vPnC)\].|Additional serotype 19A: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).||1.66|0.75|
72457651|NCT00824850|144437713|SUPERIORITY_OR_OTHER||ratio of geometric mean titers|0.8|||||TWO_SIDED|95.0|0.5|1.17|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(7vPnC/13vPnC) - (MnCC/13vPnC)\].|7vPnC serotype 4: ratio of GMTs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).||1.17|0.50|
72457652|NCT00824850|144437713|SUPERIORITY_OR_OTHER||ratio of geometric mean titers|1.1|||||TWO_SIDED|95.0|0.7|1.73|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(7vPnC/13vPnC) - (MnCC/13vPnC)\].|7vPnC serotype 6B: ratio of GMTs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).||1.73|0.70|
72457653|NCT00824850|144437713|SUPERIORITY_OR_OTHER||ratio of geometric mean titers|0.8|||||TWO_SIDED|95.0|0.61|1.15|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(7vPnC/13vPnC) - (MnCC/13vPnC)\].|7vPnC serotype 9V: ratio of GMTs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).||1.15|0.61|
72457654|NCT00824850|144437713|SUPERIORITY_OR_OTHER||ratio of geometric mean titers|0.8|||||TWO_SIDED|95.0|0.56|1.25|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(7vPnC/13vPnC) - (MnCC/13vPnC)\].|7vPnC serotype 14: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).||1.25|0.56|
72457655|NCT00824850|144437713|SUPERIORITY_OR_OTHER||ratio of geometric mean titers|0.8|||||TWO_SIDED|95.0|0.51|1.4|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(7vPnC/13vPnC) - (MnCC/13vPnC)\].|7vPnC serotype 18C: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).||1.40|0.51|
72457656|NCT00824850|144437713|SUPERIORITY_OR_OTHER||ratio of geometric mean titers|0.6|||||TWO_SIDED|95.0|0.32|1.12|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(7vPnC/13vPnC) - (MnCC/13vPnC)\].|7vPnC serotype 19F: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).||1.12|0.32|
72457657|NCT00824850|144437713|SUPERIORITY_OR_OTHER||ratio of geometric mean titers|0.6|||||TWO_SIDED|95.0|0.38|0.85|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(7vPnC/13vPnC) - (MnCC/13vPnC)\].|7vPnC serotype 23F: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).||0.85|0.38|
72457658|NCT00824850|144437713|SUPERIORITY_OR_OTHER||ratio of geometric mean titers|1.3|||||TWO_SIDED|95.0|0.75|2.22|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(7vPnC/13vPnC) - (MnCC/13vPnC)\].|Additional serotype 1: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).||2.22|0.75|
72457659|NCT00824850|144437713|SUPERIORITY_OR_OTHER||ratio of geometric mean titers|1.1|||||TWO_SIDED|95.0|0.82|1.61|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(7vPnC/13vPnC) - (MnCC/13vPnC)\].|Additional serotype 3: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).||1.61|0.82|
72500343|NCT03193866|144530966|SUPERIORITY||Difference in proportion|-47.3|||||TWO_SIDED|95.0|-53.0|-41.7||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||-41.7|-53.0|
72500344|NCT03193866|144530966|SUPERIORITY||Difference in proportion|-43.1|||||TWO_SIDED|95.0|-49.6|-36.6||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||-36.6|-49.6|
72457660|NCT00824850|144437713|SUPERIORITY_OR_OTHER||ratio of geometric mean titers|0.9|||||TWO_SIDED|95.0|0.36|2.13|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(7vPnC/13vPnC) - (MnCC/13vPnC)\].|Additional serotype 5: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).||2.13|0.36|
72620829|NCT01887600|144772758|SUPERIORITY||Least squares mean difference|2.051|||<|0.001|TWO_SIDED|95.0|1.86|2.24||LSM Difference p-value is for test of differences.|Mixed Models Analysis|||Hb change from BL to week 14. A Mixed Model of Repeated Measures was applied using the visits up to Week 104. The results were based on the estimated difference between the two treatment arms by visit. The model included treatment arm, region, CV history, visits and visit by treatment as categorical variables and baseline Hb and baseline eGFR as continuous variables.||2.24|1.86|<0.001
72620830|NCT01887600|144772758|SUPERIORITY||Least squares mean difference|1.987|||<|0.001|TWO_SIDED|95.0|1.79|2.19||LSM Difference p-value is for test of differences.|Mixed Models Analysis|||Hb change from BL to week 16. A Mixed Model of Repeated Measures was applied. The results were based on the estimated difference between the two treatment arms by visit. The model included treatment arm, region, CV history, visits and visit by treatment as categorical variables and baseline Hb and baseline eGFR as continuous variables.||2.19|1.79|<0.001
72457661|NCT00824850|144437713|SUPERIORITY_OR_OTHER||ratio of geometric mean titers|0.9|||||TWO_SIDED|95.0|0.55|1.39|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(7vPnC/13vPnC) - (MnCC/13vPnC)\].|Additional serotype 6A: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).||1.39|0.55|
72457662|NCT00824850|144437713|SUPERIORITY_OR_OTHER||ratio of geometric mean titers|1.1|||||TWO_SIDED|95.0|0.73|1.7|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(7vPnC/13vPnC) - (MnCC/13vPnC)\].|Additional serotype 7F: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).||1.70|0.73|
72457663|NCT00824850|144437713|SUPERIORITY_OR_OTHER||ratio of geometric mean titers|0.9|||||TWO_SIDED|95.0|0.5|1.63|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(7vPnC/13vPnC) - (MnCC/13vPnC)\].|Additional serotype 19A: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).||1.63|0.50|
72457664|NCT00824850|144437714|SUPERIORITY_OR_OTHER||ratio of geometric mean titers|0.7|||||TWO_SIDED|95.0|0.35|1.27|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(7vPnC/13vPnC) - (MnCC/13vPnC)\].|7vPnC serotype 4: ratio of GMTs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).||1.27|0.35|
72457665|NCT00824850|144437714|SUPERIORITY_OR_OTHER||ratio of geometric mean titers|1.3|||||TWO_SIDED|95.0|0.77|2.05|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(7vPnC/13vPnC) - (MnCC/13vPnC)\].|7vPnC serotype 6B: ratio of GMTs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).||2.05|0.77|
72457666|NCT00824850|144437714|SUPERIORITY_OR_OTHER||ratio of geometric mean titers|0.9|||||TWO_SIDED|95.0|0.54|1.44|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(7vPnC/13vPnC) - (MnCC/13vPnC)\].|7vPnC serotype 9V: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).||1.44|0.54|
72457667|NCT00824850|144437714|SUPERIORITY_OR_OTHER||ratio of geometric mean titers|0.6|||||TWO_SIDED|95.0|0.38|0.95|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(7vPnC/13vPnC) - (MnCC/13vPnC)\].|7vPnC serotype 14: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).||0.95|0.38|
72457668|NCT00824850|144437714|SUPERIORITY_OR_OTHER||ratio of geometric mean titers|1.1|||||TWO_SIDED|95.0|0.64|1.91|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(7vPnC/13vPnC) - (MnCC/13vPnC)\].|7vPnC serotype 18C: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).||1.91|0.64|
72457669|NCT00824850|144437714|SUPERIORITY_OR_OTHER||ratio of geometric mean titers|0.7|||||TWO_SIDED|95.0|0.28|1.62|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(7vPnC/13vPnC) - (MnCC/13vPnC)\].|7vPnC serotype 19F: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).||1.62|0.28|
72457670|NCT00824850|144437714|SUPERIORITY_OR_OTHER||ratio of geometric mean titers|1.4|||||TWO_SIDED|95.0|0.68|2.81|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(7vPnC/13vPnC) - (MnCC/13vPnC)\].|7vPnC serotype 23F: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).||2.81|0.68|
72457671|NCT00824850|144437714|SUPERIORITY_OR_OTHER||ratio of geometric mean titers|1.0|||||TWO_SIDED|95.0|0.53|1.77|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(7vPnC/13vPnC) - (MnCC/13vPnC)\].|Additional serotype 1: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).||1.77|0.53|
72457672|NCT00824850|144437714|SUPERIORITY_OR_OTHER||ratio of geometric mean titers|1.1|||||TWO_SIDED|95.0|0.69|1.81|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(7vPnC/13vPnC) - (MnCC/13vPnC)\].|Additional serotype 3: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).||1.81|0.69|
72457673|NCT00824850|144437714|SUPERIORITY_OR_OTHER||ratio of geometric mean titers|0.8|||||TWO_SIDED|95.0|0.32|1.85|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(7vPnC/13vPnC) - (MnCC/13vPnC)\].|Additional serotype 5: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).||1.85|0.32|
72457674|NCT00824850|144437714|SUPERIORITY_OR_OTHER||ratio of geometric mean titers|1.4|||||TWO_SIDED|95.0|0.8|2.36|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(7vPnC/13vPnC) - (MnCC/13vPnC)\].|Additional serotype 6A: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).||2.36|0.80|
72457675|NCT00824850|144437714|SUPERIORITY_OR_OTHER||ratio of geometric mean titers|1.3|||||TWO_SIDED|95.0|0.65|2.44|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(7vPnC/13vPnC) - (MnCC/13vPnC)\].|Additional serotype 7F: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).||2.44|0.65|
72457676|NCT00824850|144437714|SUPERIORITY_OR_OTHER||ratio of geometric mean titers|0.9|||||TWO_SIDED|95.0|0.46|1.57|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(7vPnC/13vPnC) - (MnCC/13vPnC)\].|Additional serotype 19A: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).||1.57|0.46|
72457677|NCT00824850|144437717|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-10.2|10.9||||||7vPnC serotype 4: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.9|-10.2|
72457678|NCT00824850|144437717|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-10.0|10.1||||||7vPnC serotype 6B: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.1|-10.0|
72457679|NCT00824850|144437717|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-9.4|10.3||||||7vPnC serotype 9V: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.3|-9.4|
72457680|NCT00824850|144437717|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-9.4|10.3||||||7vPnC serotype 14: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.3|-9.4|
72457681|NCT00824850|144437717|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-9.5|10.0||||||7vPnC serotype 18C: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.0|-9.5|
72457682|NCT00824850|144437717|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-9.4|10.3||||||7vPnC serotype 19F: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.3|-9.4|
72457683|NCT00824850|144437717|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-10.0|10.1||||||7vPnC serotype 23F: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.1|-10.0|
72457684|NCT00824850|144437717|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-9.4|10.3||||||Additional serotype 1: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.3|-9.4|
72563027|NCT00292227|144658105|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.48||||||95.0|-0.72|1.68|||ANOVA|The ANOVA model included the factors treatment, period, sequence, and subject(sequence).|The direction of the estimate is Moxifloxacin - Placebo. Mean difference was estimated from the ANOVA model.|For the analysis of the assay sensitivity, an ANOVA with the factors treatment, period, sequence, and subject(sequence) for comparison of moxifloxacin vs placebo (cross-over comparison) was performed. The point estimates for the difference between placebo and positive control (moxifloxacin) and the respective 95% confidence intervals were calculated.||1.68|-0.72|
72563028|NCT00292227|144658106|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.51||||||95.0|0.3|2.73|||ANOVA|The ANOVA model included the factors treatment, period, sequence, and subject(sequence).|The direction of the estimate is Moxifloxacin - Placebo. Mean difference was estimated from the ANOVA model.|For the analysis of the assay sensitivity, an ANOVA with the factors treatment, period, sequence, and subject(sequence) for comparison of moxifloxacin vs placebo (cross-over comparison) was performed. The point estimates for the difference between placebo and positive control (moxifloxacin) and the respective 95% confidence intervals were calculated.||2.73|0.30|
72457685|NCT00824850|144437717|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-9.5|10.0||||||Additional serotype 3: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.0|-9.5|
72457686|NCT00824850|144437717|SUPERIORITY_OR_OTHER||difference in proportions|3.1|||||TWO_SIDED|95.0|-9.3|17.0||||||Additional serotype 5: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||17.0|-9.3|
72620831|NCT01887600|144772758|SUPERIORITY||Least squares mean difference|1.841|||<|0.001|TWO_SIDED|95.0|1.64|2.05||LSM Difference p-value is for test of differences.|Mixed Models Analysis|||Hb change from BL to week 18. A Mixed Model of Repeated Measures was applied. The results were based on the estimated difference between the two treatment arms by visit. The model included treatment arm, region, CV history, visits and visit by treatment as categorical variables and baseline Hb and baseline eGFR as continuous variables.||2.05|1.64|<0.001
72620832|NCT01887600|144772758|SUPERIORITY||Least squares mean difference|1.824|||<|0.001|TWO_SIDED|95.0|1.61|2.04||LSM Difference p-value is for test of differences.|Mixed Models Analysis|||Hb change from BL to week 20. A Mixed Model of Repeated Measures was applied. The results were based on the estimated difference between the two treatment arms by visit. The model included treatment arm, region, CV history, visits and visit by treatment as categorical variables and baseline Hb and baseline eGFR as continuous variables.||2.04|1.61|<0.001
72392452|NCT04518293|144292266|OTHER|95% CI for risk difference utilized Newcombe estimation method.|Risk Difference (RD)|-0.54|||||TWO_SIDED|95.0|-3.078|1.108||||||The Risk difference (95% CI) in percentage of participants with eGFR drop of over 30% at Week 6 was calculated between GMRx2 and dual-TI arms.||1.108|-3.078|
72457687|NCT00824850|144437717|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-9.4|10.3||||||Additional serotype 6A: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.3|-9.4|
72457688|NCT00824850|144437717|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-10.0|10.1||||||Additional serotype 7F: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.1|-10.0|
72457689|NCT00824850|144437717|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-9.5|10.0||||||Additional serotype 19A: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.0|-9.5|
72457690|NCT00824850|144437718|SUPERIORITY_OR_OTHER||difference in proportions|-2.6|||||TWO_SIDED|95.0|-13.9|8.0||||||7vPnC serotype 4: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||8.0|-13.9|
72457691|NCT00824850|144437718|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-10.2|10.6||||||7vPnC serotype 6B: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.6|-10.2|
72457692|NCT00824850|144437718|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-9.4|10.3||||||7vPnC serotype 9V: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.3|-9.4|
72457693|NCT00824850|144437718|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-9.5|10.3||||||7vPnC serotype 14: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.3|-9.5|
72392453|NCT04518293|144292266|OTHER|95% CI for risk difference utilized Newcombe estimation method.|Risk Difference (RD)|-0.18|||||TWO_SIDED|95.0|-2.571|1.37||||||The Risk difference (95% CI) in percentage of participants with eGFR drop of over 30% at Week 6 was calculated between GMRx2 and dual-AI arms.||1.370|-2.571|
72457694|NCT00824850|144437718|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-10.0|10.1||||||7vPnC serotype 18C: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.1|-10.0|
72457695|NCT00824850|144437718|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-10.1|10.5||||||7vPnC serotype 19F: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.5|-10.1|
72457696|NCT00824850|144437718|SUPERIORITY_OR_OTHER||difference in proportions|3.0|||||TWO_SIDED|95.0|-9.1|16.6||||||7vPnC serotype 23F: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||16.6|-9.1|
72457697|NCT00824850|144437718|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-10.0|10.1||||||Additional serotype 1: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.1|-10.0|
72457698|NCT00824850|144437718|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-9.4|10.3||||||Additional serotype 3: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.3|-9.4|
72500345|NCT03193866|144530966|SUPERIORITY||Difference in proportion|-41.3|||||TWO_SIDED|95.0|-46.4|-36.2||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||-36.2|-46.4|
72457699|NCT00824850|144437718|SUPERIORITY_OR_OTHER||difference in proportions|3.3|||||TWO_SIDED|95.0|-8.6|17.2||||||Additional serotype 5: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||17.2|-8.6|
72457700|NCT00824850|144437718|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-9.5|10.0||||||Additional serotype 6A: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.0|-9.5|
72457701|NCT00824850|144437718|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-9.7|10.6||||||Additional serotype 7F: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.6|-9.7|
72457702|NCT00824850|144437718|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-9.5|10.0||||||Additional serotype 19A: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.0|-9.5|
72457703|NCT03659136|144437738|OTHER||Hazard Ratio (HR)|1.19||||0.6534|TWO_SIDED|95.0|0.55|2.59|||Log-rank test|Two-sided log-rank test stratified for presence of baseline bone-only metastases, prior (CDK) 4/6 inhibitor treatment and menopause status.|Comparison vs. Placebo+Everolimus+Exemestane.|Cox proportional hazards model stratified for presence of baseline bone-only metastases, prior cyclin-dependent kinase (CDK) 4/6 inhibitor treatment and menopause status.||2.59|0.55|0.6534
72457704|NCT03659136|144437739|OTHER||Hazard Ratio (HR)|0.5||||0.1797|TWO_SIDED|95.0|0.18|1.4|||Log rank test|Two-sided log-rank test stratified for presence of baseline bone-only metastases, prior CDK 4/6 inhibitor treatment and menopause status.|Comparison vs. Placebo+Everolimus+Exemestane.|Cox proportional hazards model stratified for presence of baseline bone-only metastases, prior cyclin-dependent kinase (CDK) 4/6 inhibitor treatment and menopause status.||1.40|0.18|0.1797
72457705|NCT03659136|144437740|OTHER||Odds Ratio (OR)|1.31||||0.4932|TWO_SIDED|95.0|0.6|2.86|||Regression, Logistic|Logistic regression model adjusted for presence of baseline bone-only metastases, prior CDK 4/6 inhibitor treatment and menopause status.|Comparison vs. Placebo+everolimus+exemestane. An odds ratio \>1 indicates a benefit to the xentuzumab arm.|||2.86|0.60|0.4932
72457706|NCT03659136|144437742|OTHER||Odds Ratio (OR)|1.2||||0.7759|TWO_SIDED|95.0|0.34|4.43|||Regression, Logistic|Logistic regression model adjusted for presence of baseline bone-only metastases, prior CDK 4/6 inhibitor treatment and menopause status.|Comparison vs. Placebo+everolimus+exemestane. An odds ratio \>1 indicates a benefit to the xentuzumab arm.|||4.43|0.34|0.7759
72457707|NCT03659136|144437743|OTHER||Cox Proportional Hazard|0.97||||0.9279|TWO_SIDED|95.0|0.54|1.76|||Log Rank|Two-sided log-rank test stratified for presence of baseline bone-only metastases, prior CDK4/6 inhibitor treatment and menopause status.|Comparison versus Placebo+everolimus+exemestane.|Cox proportional hazards model stratified for presence of baseline bone-only metastases, prior cyclin-dependent kinase (CDK) 4/6 inhibitor treatment and menopause status.||1.76|0.54|0.9279
72457708|NCT01277302|144437759|SUPERIORITY_OR_OTHER||Estimated interaction effect|0.071|STANDARD_ERROR_OF_MEAN|0.107||0.5091||||||This is the p-value of the treatment by time interaction in the longitudinal model. Analysis was not adjusted for multiple comparisons as there was only 1 comparison. p \< 0.05 (2-sided) was required for significance.|Longitudinal mixed model|The analysis was stratified by disease (BRVO or CRVO), randomization month, and randomization BCVA score category (≤35, \>35 to ≤50, or \>50 letters).||The null hypothesis was that there was no difference in the trend of change from Baseline in the visual acuity scores from Month 7 to Month 15 between the 2 treatment groups as assessed by the interaction term of treatment by time in a longitudinal model.||||0.5091
72457709|NCT00413283|144437770|SUPERIORITY_OR_OTHER|||||||0.972|||||||Satterthwaite t-test|||||||0.972
72457710|NCT00413283|144437770|SUPERIORITY_OR_OTHER|||||||0.725|||||||Satterthwaite t-test|||||||0.725
72457711|NCT00413283|144437770|SUPERIORITY_OR_OTHER|||||||0.312|||||||Satterthwaite t-test|||||||0.312
72457712|NCT00413283|144437771|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||||||1.000
72457713|NCT00413283|144437771|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||||||1.000
72457714|NCT00413283|144437771|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||||||1.000
72457715|NCT00413283|144437772|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||||||1.000
72457716|NCT00413283|144437772|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||||||1.000
72457717|NCT00413283|144437772|SUPERIORITY_OR_OTHER|||||||0.342|||||||Fisher Exact|||||||0.342
72457718|NCT00413283|144437773|SUPERIORITY_OR_OTHER|||||||0.454|||||||Satterthwaite t-test|||||||0.454
72457719|NCT00413283|144437773|SUPERIORITY_OR_OTHER|||||||0.101|||||||Satterthwaite t-test|||||||0.101
72457720|NCT00413283|144437773|SUPERIORITY_OR_OTHER|||||||0.199|||||||Satterthwaite t-test|||||||0.199
72457721|NCT00413283|144437774|SUPERIORITY_OR_OTHER|||||||0.662|||||||Fisher Exact|||||||0.662
72457722|NCT00413283|144437774|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||||||1.000
72457723|NCT00413283|144437774|SUPERIORITY_OR_OTHER|||||||0.662|||||||Fisher Exact|||||||0.662
72457724|NCT00246129|144437776|SUPERIORITY|||||||0.467|||||||Log Rank|||||||0.467
72457725|NCT00246129|144437777|SUPERIORITY|||||||0.138|||||||Log Rank|||||||0.138
72620833|NCT01887600|144772758|SUPERIORITY||Least squares mean difference|1.651|||<|0.001|TWO_SIDED|95.0|1.43|1.87||LSM Difference p-value is for test of differences.|Mixed Models Analysis|||Hb change from BL to week 22. A Mixed Model of Repeated Measures was applied. The results were based on the estimated difference between the two treatment arms by visit.The model included treatment arm, region, CV history, visits and visit by treatment as categorical variables and baseline Hb and baseline eGFR as continuous variables.||1.87|1.43|<0.001
72457726|NCT02005172|144437796|EQUIVALENCE|The primary analysis used the TOST procedure for equivalence. A difference of less than 10% between devices on the proportion of diagnostic days during the monitoring period was considered to be equivalent. We hypothesized that the percentage of diagnostic days for the ELR and the KM would be 20% and 15%, respectively.||||||||||||||||For the primary endpoint, equivalence testing using the two one-sided test procedure was used to compare the proportion of (unpaired) days in which a diagnostic recording was made with each device during the monitoring period. For the purpose of this study, a difference of less than 10% between devices on the rate of detection of arrhythmias was taken to indicate equivalence.|"Descriptive statistics (means, standard deviation (SD), percentages) were used to summarize the demographic and clinical characteristics of the patients. The total number of tracings and the percentage of tracings with arrhythmias for each device were also calculated.~For the primary endpoint, equivalence testing using the two one-sided test (TOST) procedure was used to compare the proportion of (unpaired) days in which a diagnostic recording was made with each device during the monitoring period. Patients were asked to use both devices for the same duration. For the purpose of this study, a difference of less than 10% between devices on the rate of detection of arrhythmias was taken to indicate equivalence. The primary hypothesis was that the KM"|||
72457727|NCT01853384|144437823|SUPERIORITY_OR_OTHER|||||||0.5348||||||Analysis adjusted for sites, with significance being at P \< 0.05|Cochran-Mantel-Haenszel|||||||.5348
72457728|NCT01853384|144437824|SUPERIORITY_OR_OTHER|||||||0.9456|||||||Regression, Cox|||||||.9456
72457729|NCT01853384|144437826|SUPERIORITY_OR_OTHER|||||||0.6194||||||Treatment Week 01|Cochran-Mantel-Haenszel|||||||.6194
72457730|NCT01853384|144437826|SUPERIORITY_OR_OTHER|||||||0.793||||||Treatment Week 02|Cochran-Mantel-Haenszel|||||||.7930
72620834|NCT01887600|144772758|SUPERIORITY||Least squares mean difference|1.447|||<|0.001|TWO_SIDED|95.0|1.23|1.67||LSM Difference p-value is for test of differences.|Mixed Models Analysis|||Hb change from BL to week 24. A Mixed Model of Repeated Measures was applied. The results were based on the estimated difference between the two treatment arms by visit. The model included treatment arm, region, CV history, visits and visit by treatment as categorical variables and baseline Hb and baseline eGFR as continuous variables.||1.67|1.23|<0.001
72620835|NCT01887600|144772758|SUPERIORITY||Least squares mean difference|1.561|||<|0.001|TWO_SIDED|95.0|1.34|1.78||LSM Difference p-value is for test of differences.|Mixed Models Analysis|||Hb change from BL to week 28. A Mixed Model of Repeated Measures was applied. The results were based on the estimated difference between the two treatment arms by visit. The model included treatment arm, region, CV history, visits and visit by treatment as categorical variables and baseline Hb and baseline eGFR as continuous variables.||1.78|1.34|<0.001
72457731|NCT01853384|144437826|SUPERIORITY_OR_OTHER|||||||0.3362||||||Treatment Week 03|Cochran-Mantel-Haenszel|||||||0.3362
72457732|NCT01853384|144437826|SUPERIORITY_OR_OTHER|||||||0.5263||||||Treatment Week 04|Cochran-Mantel-Haenszel|||||||0.5263
72457733|NCT01853384|144437826|SUPERIORITY_OR_OTHER|||||||0.1997||||||Treatment Week 05|Cochran-Mantel-Haenszel|||||||0.1997
72457734|NCT01853384|144437826|SUPERIORITY_OR_OTHER|||||||0.1617||||||Treatment Week 06|Cochran-Mantel-Haenszel|||||||0.1617
72457735|NCT01853384|144437826|SUPERIORITY_OR_OTHER|||||||0.2611||||||Treatment Week 07|Cochran-Mantel-Haenszel|||||||0.2611
72457736|NCT01853384|144437826|SUPERIORITY_OR_OTHER|||||||0.7232||||||Treatment Week 08|Cochran-Mantel-Haenszel|||||||0.7232
72457737|NCT01853384|144437826|SUPERIORITY_OR_OTHER|||||||0.4405||||||Treatment Week 09|Cochran-Mantel-Haenszel|||||||0.4405
72457738|NCT01853384|144437826|SUPERIORITY_OR_OTHER|||||||0.3516||||||Treatment Week 10|Cochran-Mantel-Haenszel|||||||0.3516
72457739|NCT01853384|144437826|SUPERIORITY_OR_OTHER|||||||0.2821||||||Treatment Week 11|Cochran-Mantel-Haenszel|||||||0.2821
72457740|NCT01853384|144437826|SUPERIORITY_OR_OTHER|||||||0.3722||||||Treatment Week 12|Cochran-Mantel-Haenszel|||||||0.3722
72457741|NCT01853384|144437826|SUPERIORITY_OR_OTHER|||||||0.5348||||||Week 12 - Primary Endpoint|Cochran-Mantel-Haenszel|||||||0.5348
72457742|NCT01853384|144437828|SUPERIORITY_OR_OTHER|||||||0.5909||||||Week 01|ANCOVA|||||||0.5909
72457743|NCT01853384|144437828|SUPERIORITY_OR_OTHER|||||||0.8234||||||Week 02|ANCOVA|||||||0.8234
72457744|NCT01853384|144437828|SUPERIORITY_OR_OTHER|||||||0.1556||||||Week 03|ANCOVA|||||||0.1556
72457745|NCT01853384|144437828|SUPERIORITY_OR_OTHER|||||||0.3487||||||Week 04|ANCOVA|||||||0.3487
72457746|NCT01853384|144437828|SUPERIORITY_OR_OTHER|||||||0.1064||||||Week 05|ANCOVA|||||||0.1064
72457747|NCT01853384|144437828|SUPERIORITY_OR_OTHER|||||||0.2888||||||Week 06|ANCOVA|||||||0.2888
72457748|NCT01853384|144437828|SUPERIORITY_OR_OTHER|||||||0.6095||||||Week 07|ANCOVA|||||||0.6095
72457749|NCT01853384|144437828|SUPERIORITY_OR_OTHER|||||||0.1566||||||Week 08|ANCOVA|||||||0.1566
72392454|NCT04518293|144292267|OTHER|95% CI for risk difference utilized Newcombe estimation method.|Risk Difference (RD)|10.55|||||TWO_SIDED|95.0|5.422|15.138||||||The Risk difference (95% CI) in percentage of participants with serum sodium \<135mmol/L or \>145 mmol/L, and/or serum potassium \<3.5 mmol/L or \>5.5mmol/L at Week 12 was calculated between GMRx2 and dual-TA arms.||15.138|5.422|
72457750|NCT01853384|144437828|SUPERIORITY_OR_OTHER|||||||0.4216||||||Week 09|ANCOVA|||||||0.4216
72457751|NCT01853384|144437828|SUPERIORITY_OR_OTHER|||||||0.8166||||||Week10|ANCOVA|||||||0.8166
72457752|NCT01853384|144437828|SUPERIORITY_OR_OTHER|||||||0.9114||||||Week 11|ANCOVA|||||||0.9114
72457753|NCT01853384|144437828|SUPERIORITY_OR_OTHER|||||||0.9733||||||Week 12|ANCOVA|||||||0.9733
72457754|NCT01853384|144437829|SUPERIORITY_OR_OTHER|||||||0.7439||||||Week 01|ANCOVA|||||||0.7439
72457755|NCT01853384|144437829|SUPERIORITY_OR_OTHER|||||||0.6992||||||Week 02|ANCOVA|||||||0.6992
72457756|NCT01853384|144437829|SUPERIORITY_OR_OTHER|||||||0.0867||||||Week 03|ANCOVA|||||||0.0867
72457757|NCT01853384|144437829|SUPERIORITY_OR_OTHER|||||||0.5739||||||Week 04|ANCOVA|||||||0.5739
72457758|NCT01853384|144437829|SUPERIORITY_OR_OTHER|||||||0.6497||||||Week 05|ANCOVA|||||||0.6497
72457759|NCT01853384|144437829|SUPERIORITY_OR_OTHER|||||||0.1427||||||Week 06|ANCOVA|||||||0.1427
72457760|NCT01853384|144437829|SUPERIORITY_OR_OTHER|||||||0.0682||||||Week 07|ANCOVA|||||||0.0682
72457761|NCT01853384|144437829|SUPERIORITY_OR_OTHER|||||||0.0161||||||Week 08|ANCOVA|||||||0.0161
72457762|NCT01853384|144437829|SUPERIORITY_OR_OTHER|||||||0.0973||||||Week 09|ANCOVA|||||||0.0973
72457763|NCT01853384|144437829|SUPERIORITY_OR_OTHER|||||||0.4661||||||Week 10|ANCOVA|||||||0.4661
72457764|NCT01853384|144437829|SUPERIORITY_OR_OTHER|||||||0.601||||||Week 11|ANCOVA|||||||0.6010
72457765|NCT01853384|144437829|SUPERIORITY_OR_OTHER|||||||0.3369||||||Week 12|ANCOVA|||||||0.3369
72457766|NCT01205126|144437830|NON_INFERIORITY_OR_EQUIVALENCE|Non inferiority was demonstrated if upper bound of the 2-sided 95% CI was less than the non-inferiority margin of 1.5.|Least square mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.6||0.855|TWO_SIDED|95.0|-1.3|1.1||P-value was calculated by ANCOVA model using Baseline as covariate for change at Day 29.|ANCOVA|||||1.1|-1.3|0.855
72620836|NCT01887600|144772758|SUPERIORITY||Least squares mean difference|1.587|||<|0.001|TWO_SIDED|95.0|1.37|1.81||LSM Difference p-value is for test of differences.|Mixed Models Analysis|||Hb change From BL to week 32. A Mixed Model of Repeated Measures was applied. The results were based on the estimated difference between the two treatment arms by visit. The model included treatment arm, region, CV history, visits and visit by treatment as categorical variables and baseline Hb and baseline eGFR as continuous variables.||1.81|1.37|<0.001
72392455|NCT04518293|144292267|OTHER|95% CI for risk difference utilized Newcombe estimation method.|Risk Difference (RD)|3.11|||||TWO_SIDED|95.0|-2.776|8.49||||||The Risk difference (95% CI) in percentage of participants with serum sodium \<135mmol/L or \>145 mmol/L, and/or serum potassium \<3.5 mmol/L or \>5.5mmol/L at Week 12 was calculated between GMRx2 and dual-TI arms.||8.490|-2.776|
72392456|NCT04518293|144292267|OTHER|95% CI for risk difference utilized Newcombe estimation method.|Risk Difference (RD)|-1.6|||||TWO_SIDED|95.0|-7.807|4.174||||||The Risk difference (95% CI) in percentage of participants with serum sodium \<135mmol/L or \>145 mmol/L, and/or serum potassium \<3.5 mmol/L or \>5.5mmol/L at Week 12 was calculated between GMRx2 and dual-AI arms.||4.174|-7.807|
72392457|NCT04518293|144292268|OTHER|95% CI for risk difference utilized Newcombe estimation method.|Risk Difference (RD)|5.47|||||TWO_SIDED|95.0|0.531|9.867||||||The Risk difference (95% CI) in percentage of participants with serum sodium \<135mmol/L or \>145 mmol/L, and/or serum potassium \<3.5 mmol/L or \>5.5mmol/L at Week 6 was calculated between GMRx2 and dual-TA arms.||9.867|0.531|
72392458|NCT04518293|144292268|OTHER|95% CI for risk difference utilized Newcombe estimation method.|Risk Difference (RD)|4.92|||||TWO_SIDED|95.0|-0.136|9.397||||||The Risk difference (95% CI) in percentage of participants with serum sodium \<135mmol/L or \>145 mmol/L, and/or serum potassium \<3.5 mmol/L or \>5.5mmol/L at Week 6 was calculated between GMRx2 and dual-TI arms.||9.397|-0.136|
72392459|NCT04518293|144292268|OTHER|95% CI for risk difference utilized Newcombe estimation method.|Risk Difference (RD)|-1.6|||||TWO_SIDED|95.0|-7.299|3.567||||||The Risk difference (95% CI) in percentage of participants with serum sodium \<135mmol/L or \>145 mmol/L, and/or serum potassium \<3.5 mmol/L or \>5.5mmol/L at Week 6 was calculated between GMRx2 and dual-AI arms.||3.567|-7.299|
72392460|NCT04518293|144292269|OTHER|95% CI for risk difference utilized Newcombe estimation method.|Risk Difference (RD)|-0.06||||0.9677|TWO_SIDED|95.0|-3.825|3.019|||Wald test|||The Risk difference (95% CI) in percentage of participants with orthostatic hypotension at Week 6 was calculated between GMRx2 and dual-TA arms.||3.019|-3.825|0.9677
72392461|NCT04518293|144292269|OTHER||Risk Difference (RD)|-2.35||||0.1952|TWO_SIDED|95.0|-6.55|1.125|||Wald test|||The Risk difference (95% CI) in percentage of participants with orthostatic hypotension at Week 6 was calculated between GMRx2 and dual-TI arms.||1.125|-6.550|0.1952
72392462|NCT04518293|144292269|OTHER|95% CI for risk difference utilized Newcombe estimation method.|Risk Difference (RD)|-0.53||||0.7453|TWO_SIDED|95.0|-4.428|2.642|||Wald test|||The Risk difference (95% CI) in percentage of participants with orthostatic hypotension at Week 6 was calculated between GMRx2 and dual-AI arms.||2.642|-4.428|0.7453
72392463|NCT04518293|144292270|OTHER|95% CI for risk difference utilized Newcombe estimation method.|Risk Difference (RD)|0.12||||0.9415|TWO_SIDED|95.0|-3.657|3.222|||Wald test|||The Risk difference (95% CI) in percentage of participants with orthostatic hypotension at Week 12 was calculated between GMRx2 and dual-TA arms.||3.222|-3.657|0.9415
72392464|NCT04518293|144292270|OTHER||Risk Difference (RD)|-2.53||||0.1719|TWO_SIDED|95.0|-6.799|1.019|||Wald test|||The Risk difference (95% CI) in percentage of participants with orthostatic hypotension at Week 12 was calculated between GMRx2 and dual-TI arms.||1.019|-6.799|0.1719
72392465|NCT04518293|144292270|OTHER|95% CI for risk difference utilized Newcombe estimation method.|Risk Difference (RD)|-2.16||||0.2342|TWO_SIDED|95.0|-6.38|1.326|||Wald test|||The Risk difference (95% CI) in percentage of participants with orthostatic hypotension at Week 12 was calculated between GMRx2 and dual-AI arms.||1.326|-6.380|0.2342
72392466|NCT04518293|144292271|OTHER|95% CI for risk difference utilized Newcombe estimation method.|Risk Difference (RD)|-2.87||||0.3548|TWO_SIDED|95.0|-9.316|3.215|||Wald test|||The Risk difference (95% CI) in percentage of participants with orthostatic hypertension at Week 6 was calculated between GMRx2 and dual-TA arms.||3.215|-9.316|0.3548
72392467|NCT04518293|144292271|OTHER|95% CI for risk difference utilized Newcombe estimation method.|Risk Difference (RD)|0.94||||0.7529|TWO_SIDED|95.0|-5.356|6.8|||Wald test|||The Risk difference (95% CI) in percentage of participants with orthostatic hypertension at Week 6 was calculated between GMRx2 and dual-TI arms.||6.800|-5.356|0.7529
72392468|NCT04518293|144292271|OTHER|95% CI for risk difference utilized Newcombe estimation method.|Risk Difference (RD)|-2.32||||0.4563|TWO_SIDED|95.0|-8.791|3.772|||Wald test|||The Risk difference (95% CI) in percentage of participants with orthostatic hypertension at Week 6 was calculated between GMRx2 and dual-AI arms.||3.772|-8.791|0.4563
72392469|NCT04518293|144292272|OTHER|95% CI for risk difference utilized Newcombe estimation method.|Risk Difference (RD)|0.11||||0.9691|TWO_SIDED|95.0|-6.063|5.859|||Wald test|||The Risk difference (95% CI) in percentage of participants with orthostatic hypertension at Week 12 was calculated between GMRx2 and dual-TA arms.||5.859|-6.063|0.9691
72392470|NCT04518293|144292272|OTHER|95% CI for risk difference utilized Newcombe estimation method.|Risk Difference (RD)|-3.59||||0.2454|TWO_SIDED|95.0|-10.018|2.462|||Wald test|||The Risk difference (95% CI) in percentage of participants with orthostatic hypertension at Week 12 was calculated between GMRx2 and dual-TI arms.||2.462|-10.018|0.2454
72392471|NCT04518293|144292272|OTHER|95% CI for risk difference utilized Newcombe estimation method.|Risk Difference (RD)|-0.33||||0.913|TWO_SIDED|95.0|-6.583|5.488|||Wald test|||The Risk difference (95% CI) in percentage of participants with orthostatic hypertension at Week 12 was calculated between GMRx2 and dual-AI arms.||5.488|-6.583|0.9130
72457767|NCT01205126|144437831|NON_INFERIORITY_OR_EQUIVALENCE|Non inferiority was demonstrated if upper bound of the 2-sided 95% CI was less than the non-inferiority margin of 1.5.|Least square mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.39||0.615|TWO_SIDED|95.0|-1.0|0.6|||ANCOVA|P-value was calculated by ANCOVA model using Baseline as covariate for change at Day 29.||||0.6|-1.0|0.615
72620837|NCT01887600|144772758|SUPERIORITY||Least squares mean difference|1.69|||<|0.001|TWO_SIDED|95.0|1.46|1.92||LSM Difference p-value is for test of differences.|Mixed Models Analysis|||Hb Change from BL to week 36. A Mixed Model of Repeated Measures was applied. The results were based on the estimated difference between the two treatment arms by visit.The model included treatment arm, region, CV history, visits and visit by treatment as categorical variables and baseline Hb and baseline eGFR as continuous variables.||1.92|1.46|<0.001
72457768|NCT01205126|144437832|NON_INFERIORITY_OR_EQUIVALENCE|Non inferiority was demonstrated if upper bound of the 2-sided 95% CI was less than the non-inferiority margin of 1.5.|Least square mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.44||0.621|TWO_SIDED|95.0|-1.1|0.7|||ANCOVA|P-value was calculated by ANCOVA model using Baseline as covariate for change at Day 29.||||0.7|-1.1|0.621
72457769|NCT01205126|144437833|NON_INFERIORITY_OR_EQUIVALENCE|Non inferiority was demonstrated if upper bound of the 2-sided 95% CI was less than the non-inferiority margin of 1.5.||||||0.832|||||||ANCOVA|P-value was calculated by ANCOVA model using Baseline as covariate for change at Day 29.||||||0.832
72457770|NCT01205126|144437834|NON_INFERIORITY_OR_EQUIVALENCE|Non inferiority was demonstrated if upper bound of the 2-sided 95% CI was less than the non-inferiority margin of 1.5.||||||0.304|||||||ANCOVA|P-value was calculated by ANCOVA model using Baseline as covariate for change at Day 29||||||0.304
72457771|NCT01205126|144437835|SUPERIORITY_OR_OTHER|||||||0.276|||||||rank sum test, 2 sided|||||||0.276
72457772|NCT00486954|144437837|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.84||||0.2088|TWO_SIDED|95.0|0.64|1.11|||Log Rank|||||1.11|0.64|0.2088
72457773|NCT03331978|144437881|SUPERIORITY||Mean Difference (Net)|6.89|STANDARD_ERROR_OF_MEAN|3.91||0.08|TWO_SIDED|95.0|-0.82|14.61|||Regression, Linear|Model is adjusted for participant sex, which was found to be significantly associated with adherence in a similar repeated measures model.|Values entered are for regression coefficient for intervention indicator (versus control) and represents the adjusted difference across all follow-up time points.|Tested with repeated measures linear regression where all 6 past-month post-intervention measurements of adherence were stacked together such that each participant could contribute up to 6 records. Standard errors were adjusted for clustering on participant, and weights for presence of data were used. Fixed effects were an intervention indicator and continuous adherence measured at baseline. Model included all participants with adherence data (a) at baseline and (b) at least one follow-up month.||14.61|-0.82|.08
72457774|NCT03331978|144437882|SUPERIORITY||Odds Ratio (OR)|1.98||||0.0257|TWO_SIDED|95.0|1.09|3.6||Per above, p-value is from repeated measures logistic regression with standard errors adjusted for clustering on participant.|Regression, Logistic||Odds ratio is for intervention indicator (versus controls).|Tested with repeated measures logistic regression where all 6 past-month post-intervention measurements of adherence were stacked together such that each participant could contribute up to 6 records. Standard errors were adjusted for clustering on participant, and weights for presence of data were used. Fixed effects were an intervention indicator and baseline dichotomous adherence. Model included all participants with adherence data (a) at baseline and (b) at least one follow-up month.||3.60|1.09|.0257
72620838|NCT01887600|144772758|SUPERIORITY||Least squares mean difference|1.645|||<|0.001|TWO_SIDED|95.0|1.41|1.88||LSM Difference p-value is for test of differences.|Mixed Models Analysis|||Hb change from BL to week 40. A Mixed Model of Repeated Measures was applied. The results were based on the estimated difference between the two treatment arms by visit. The model included treatment arm, region, CV history, visits and visit by treatment as categorical variables and baseline Hb and baseline eGFR as continuous variables.||1.88|1.41|<0.001
72457775|NCT03331978|144437883|SUPERIORITY||Odds Ratio (OR)|1.82||||0.26|TWO_SIDED|95.0|0.64|5.18||As mentioned above, p-value comes from repeated measures regression with standard errors adjusted for clustering on participant.|Regression, Logistic||Odds ratio is for intervention indicator (versus controls).|Tested with repeated measures logistic regression where both post-intervention measurements were stacked together such that each participant could contribute up to 2 records. Standard errors were adjusted for clustering on participant, and weights for presence of viral suppression data were used. Fixed effects were an intervention indicator and baseline viral suppression. Model included all viral suppression data (a) at baseline and (b) close to either of the two follow-up surveys.||5.18|0.64|.26
72457776|NCT03331978|144437884|SUPERIORITY||Odds Ratio (OR)|0.57||||0.05|TWO_SIDED|95.0|0.32|1.0||As mentioned above, p-value is from repeated measures regression with standard errors adjusted for clustering on participant.|Regression, Logistic||Odds ratio is for intervention indicator (versus controls).|Tested with repeated measures logistic regression where both post-intervention responses were stacked together such that each participant could contribute up to 2 records. Standard errors were adjusted for clustering on participant, and weights for follow-up response were used. Fixed effects were an intervention indicator and baseline stigma. Model included all participants with responses (a) at baseline and (b) at least one of the two follow-up surveys.||1.00|0.32|.05
72457777|NCT03331978|144437885|SUPERIORITY||Mean Difference (Net)|-0.215|STANDARD_ERROR_OF_MEAN|0.091||0.0199|TWO_SIDED|95.0|-0.395|-0.034||As described above, p-value is from repeated measures regression with standard errors adjusted for clustering on participant|Regression, Linear||Estimation parameter is the regression coefficient for intervention indicator (vs. control) and represents the adjusted difference across both follow-up time points.|Tested with repeated measures linear regression where both post-intervention responses were stacked together such that each participant could contribute up to 2 records. Standard errors were adjusted for clustering on participant, and weights for follow-up response were used. Fixed effects were an intervention indicator and baseline stigma. Model included all participants with responses (a) at baseline and (b) at least one of the two follow-up surveys.||-0.034|-0.395|.0199
72457778|NCT00805792|144437894|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||Regression, Linear|||The statistical significance of the change was assessed by the P value associated with estimated regression coefficient (beta coefficient or slope).||||<.001
72457779|NCT00805792|144437895|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||Regression, Linear|||The statistical significance of the change was assessed by the P value associated with estimated regression coefficient (beta coefficient or slope).||||<.001
72457780|NCT00805792|144437896|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||Regression, Linear|||The statistical significance of the change was assessed by the P value associated with estimated regression coefficient (beta coefficient or slope).||||<.001
72457781|NCT01836523|144437898|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was concluded if the upper bound of 95% confidence interval was \<0.3.|Treatment difference|-0.2|||||TWO_SIDED|95.0|-0.32|-0.07||||||Analysis was performed using MMRMs where all post-baseline measurements for the specific variable from planned visits up to week 52 and obtained no later than 1 day after withdrawal from treatment were entered as the dependent variable, and visit, treatment, country and the stratification variable (4 levels: HbA1c \< 8.5% and ≥8.5%, each intersected by BMI≤27 kg/m2 and \>27 kg/m2) were included as fixed factors and the corresponding baseline value as covariate.||-0.07|-0.32|
72457782|NCT01836523|144437898|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was concluded if the upper bound of 95% confidence interval was \<0.3.|Treatment difference|-0.15|||||TWO_SIDED|95.0|-0.27|-0.03||||||Analysis was performed using MMRMs where all post-baseline measurements for the specific variable from planned visits up to week 52 and obtained no later than 1 day after withdrawal from treatment were entered as the dependent variable, and visit, treatment, country and the stratification variable (4 levels: HbA1c \< 8.5% and ≥8.5%, each intersected by BMI≤27 kg/m2 and \>27 kg/m2) were included as fixed factors and the corresponding baseline value as covariate.||-0.03|-0.27|
72457783|NCT01836523|144437898|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was concluded if the upper bound of 95% confidence interval was \<0.3.|Treatment difference|-0.09|||||TWO_SIDED|95.0|-0.21|0.03||||||Analysis was performed using MMRMs where all post-baseline measurements for the specific variable from planned visits up to week 52 and obtained no later than 1 day after withdrawal from treatment were entered as the dependent variable, and visit, treatment, country and the stratification variable (4 levels: HbA1c \< 8.5% and ≥8.5%, each intersected by BMI≤27 kg/m2 and \>27 kg/m2) were included as fixed factors and the corresponding baseline value as covariate.||0.03|-0.21|
72457784|NCT01836523|144437899|SUPERIORITY_OR_OTHER||Treatment difference|-4.9|||<|0.0001|TWO_SIDED|95.0|-5.65|-4.16|||Mixed Models Analysis|||Analysis was performed using MMRMs where all post-baseline measurements for the specific variable from planned visits up to week 52 and obtained no later than 1 day after withdrawal from treatment were entered as the dependent variable, and visit, treatment, country and the stratification variable (4 levels: HbA1c \< 8.5% and ≥8.5%, each intersected by BMI≤27 kg/m2 and \>27 kg/m2) were included as fixed factors and the corresponding baseline value as covariate.||-4.16|-5.65|<0.0001
72457785|NCT01836523|144437899|SUPERIORITY_OR_OTHER||Treatment difference|-3.55|||<|0.0001|TWO_SIDED|95.0|-4.29|-2.81|||Mixed Models Analysis|||Analysis was performed using MMRMs where all post-baseline measurements for the specific variable from planned visits up to week 52 and obtained no later than 1 day after withdrawal from treatment were entered as the dependent variable, and visit, treatment, country and the stratification variable (4 levels: HbA1c \< 8.5% and ≥8.5%, each intersected by BMI≤27 kg/m2 and \>27 kg/m2) were included as fixed factors and the corresponding baseline value as covariate.||-2.81|-4.29|<0.0001
72457786|NCT01836523|144437899|SUPERIORITY_OR_OTHER||Treatment difference|-2.19|||<|0.0001|TWO_SIDED|95.0|-2.91|-1.47|||Mixed Models Analysis|||Analysis was performed using MMRMs where all post-baseline measurements for the specific variable from planned visits up to week 52 and obtained no later than 1 day after withdrawal from treatment were entered as the dependent variable, and visit, treatment, country and the stratification variable (4 levels: HbA1c \< 8.5% and ≥8.5%, each intersected by BMI≤27 kg/m2 and \>27 kg/m2) were included as fixed factors and the corresponding baseline value as covariate.||-1.47|-2.91|<0.0001
72457787|NCT01836523|144437900|SUPERIORITY_OR_OTHER||Treatment ratio|0.92|||<|0.0001|TWO_SIDED|95.0|0.88|0.96|||Mixed Models Analysis|||Analysis was done using MMRMs where all post-baseline measurements for specific variable from planned visits up to week 52 and obtained no later than 1 day after withdrawal from treatment were entered as dependent variable, and visit, treatment, country and stratification variable (4 levels: HbA1c \< 8.5% and ≥8.5%, each intersected by BMI≤27 kg/m2 and \>27 kg/m2) were included as fixed factors and the corresponding baseline value as covariate. The measurements were log-transformed before analysis||0.96|0.88|<0.0001
72457788|NCT01836523|144437900|SUPERIORITY_OR_OTHER||Treatment ratio|0.95||||0.0148|TWO_SIDED|95.0|0.91|0.99|||Mixed Models Analysis|||Analysis was done using MMRMs where all post-baseline measurements for specific variable from planned visits up to week 52 and obtained no later than 1 day after withdrawal from treatment were entered as dependent variable, and visit, treatment, country and stratification variable (4 levels: HbA1c \< 8.5% and ≥8.5%, each intersected by BMI≤27 kg/m2 and \>27 kg/m2) were included as fixed factors and the corresponding baseline value as covariate. The measurements were log-transformed before analysis||0.99|0.91|0.0148
72457789|NCT01836523|144437900|SUPERIORITY_OR_OTHER||Treatment ratio|1.0||||0.9615|TWO_SIDED|95.0|0.96|1.04|||Mixed Models Analysis|||Analysis was done using MMRMs where all post-baseline measurements for specific variable from planned visits up to week 52 and obtained no later than 1 day after withdrawal from treatment were entered as dependent variable, and visit, treatment, country and stratification variable (4 levels: HbA1c \< 8.5% and ≥8.5%, each intersected by BMI≤27 kg/m2 and \>27 kg/m2) were included as fixed factors and the corresponding baseline value as covariate. The measurements were log-transformed before analysis||1.04|0.96|0.9615
72457790|NCT01836523|144437901|SUPERIORITY_OR_OTHER||Rate ratio|1.31||||0.0081|TWO_SIDED|95.0|1.07|1.59|||Negative binomial regression|||The endpoint was analysed using a negative binomial regression model with a log-link function and the log of the time period in which an occurrence of a hypoglycaemic episode was considered treatment emergent as offset. The model included fixed factors (treatment, country, stratification group) and a covariate (baseline HbA1c).||1.59|1.07|0.0081
72457791|NCT01836523|144437901|SUPERIORITY_OR_OTHER||Rate ratio|1.27||||0.0219|TWO_SIDED|95.0|1.03|1.55|||Negative binomial regression|||The endpoint was analysed using a negative binomial regression model with a log-link function and the log of the time period in which an occurrence of a hypoglycaemic episode was considered treatment emergent as offset. The model included fixed factors (treatment, country, stratification group) and a covariate (baseline HbA1c).||1.55|1.03|0.0219
72457792|NCT01836523|144437901|SUPERIORITY_OR_OTHER||Rate ratio|1.17||||0.1079|TWO_SIDED|95.0|0.97|1.43|||Negative binomial regression|||The endpoint was analysed using a negative binomial regression model with a log-link function and the log of the time period in which an occurrence of a hypoglycaemic episode was considered treatment emergent as offset. The model included fixed factors (treatment, country, stratification group) and a covariate (baseline HbA1c).||1.43|0.97|0.1079
72457793|NCT00813709|144437905|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.555||||0.002|TWO_SIDED|95.0|0.378|0.816|||Log Rank|||||0.816|0.378|0.002
72457794|NCT00813709|144437905|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.573||||0.006|TWO_SIDED|95.0|0.391|0.839|||Log Rank|||||0.839|0.391|0.006
72457795|NCT00813709|144437905|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.993||||0.941|TWO_SIDED|95.0|0.654|1.51|||Log Rank|||||1.510|0.654|0.941
72457796|NCT00813709|144437906|SUPERIORITY_OR_OTHER|||||||0.205||95.0|||||Log Rank|||||||0.205
72620839|NCT01887600|144772758|SUPERIORITY||Least squares mean difference|1.699|||<|0.001|TWO_SIDED|95.0|1.45|1.94||LSM Difference p-value is for test of differences.|Mixed Models Analysis|||Hb change from BL to week 44. A Mixed Model of Repeated Measures was applied. The results were based on the estimated difference between the two treatment arms by visit. The model included treatment arm, region, CV history, visits and visit by treatment as categorical variables and baseline Hb and baseline eGFR as continuous variables.||1.94|1.45|<0.001
72620840|NCT01887600|144772758|SUPERIORITY||Least squares mean difference|1.446|||<|0.001|TWO_SIDED|95.0|1.2|1.69||LSM Difference p-value is for test of differences.|Mixed Models Analysis|||Hb change From BL to week 48. A Mixed Model of Repeated Measures was applied. The results were based on the estimated difference between the two treatment arms by visit. The model included treatment arm, region, CV history, visits and visit by treatment as categorical variables and baseline Hb and baseline eGFR as continuous variables.||1.69|1.20|<0.001
72457797|NCT00813709|144437906|SUPERIORITY_OR_OTHER|||||||0.263||95.0|||||Log Rank|||||||0.263
72457798|NCT00813709|144437906|SUPERIORITY_OR_OTHER|||||||0.629||95.0|||||Log Rank|||||||0.629
72457799|NCT02753075|144437929|SUPERIORITY_OR_OTHER||Least Square (LS) mean difference|0.09||||0.829|TWO_SIDED|95.0|-0.289|0.461||For the Week 8 comparisons of two Oral Rinses against the Placebo Rinse, Dunnett's multiplicity adjustment is applied.|ANCOVA||From ANCOVA model with treatment as factor and baseline Schiff score as covariate. Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|||0.461|-0.289|0.8290
72457800|NCT02753075|144437929|SUPERIORITY_OR_OTHER||LS mean difference|-0.01||||0.9993|TWO_SIDED|95.0|-0.372|0.362||For the Week 8 comparisons of two Oral Rinses against the Placebo Rinse, Dunnett's multiplicity adjustment is applied.|ANCOVA||From ANCOVA model with treatment as factor and baseline Schiff score as covariate. Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|||0.362|-0.372|0.9993
72457801|NCT02753075|144437930|SUPERIORITY_OR_OTHER||LS mean difference|0.09||||0.5892|TWO_SIDED|95.0|-0.242|0.424|||ANCOVA||From ANCOVA model with treatment as factor and baseline Schiff score as covariate. Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|||0.424|-0.242|0.5892
72457802|NCT02753075|144437931|SUPERIORITY_OR_OTHER||LS mean difference|0.14||||0.2825|TWO_SIDED|95.0|-0.116|0.396|||ANCOVA||From ANCOVA model with treatment as factor and baseline Schiff score as covariate. Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|||0.396|-0.116|0.2825
72457803|NCT02753075|144437931|SUPERIORITY_OR_OTHER||LS mean difference|0.03||||0.8448|TWO_SIDED|95.0|-0.229|0.28|||ANCOVA||From ANCOVA model with treatment as factor and baseline Schiff score as covariate. Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|||0.280|-0.229|0.8448
72457804|NCT02753075|144437931|SUPERIORITY_OR_OTHER||LS mean difference|0.11||||0.3784|TWO_SIDED|95.0|-0.141|0.371|||ANCOVA||From ANCOVA model with treatment as factor and baseline Schiff score as covariate. Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|||0.371|-0.141|0.3784
72457805|NCT02753075|144437932|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.0||||0.1688|TWO_SIDED|95.0|-10.0|0.0||Wilcoxon rank sum test.|Wilcoxon rank sum test||Median difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment. Median Difference has been calculated from non-parametric Hodges-Lehmann estimations.|||0.000|-10.00|0.1688
72457806|NCT02753075|144437932|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.0||||0.438|TWO_SIDED|95.0|-5.0|0.0||Wilcoxon rank sum test.|Wilcoxon rank sum test||Median difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment. Median Difference has been calculated from non-parametric Hodges-Lehmann estimations.|||0.000|-5.000|0.4380
72457807|NCT02753075|144437932|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.0||||0.5693|TWO_SIDED|95.0|-5.0|0.0||Wilcoxon rank sum test.|Wilcoxon rank sum test||Median difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment. Median Difference has been calculated from non-parametric Hodges-Lehmann estimations.|||0.000|-5.000|0.5693
72457808|NCT02753075|144437933|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.0||||0.7789|TWO_SIDED|95.0|-5.0|0.0||Wilcoxon rank sum test.|Wilcoxon rank sum test||Median difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment. From non-parametric Hodges-Lehmann estimations.|||0.000|-5.000|0.7789
72457809|NCT02753075|144437933|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.0||||0.7214|TWO_SIDED|95.0|-5.0|0.0||Wilcoxon rank sum test.|Wilcoxon rank sum test||Median difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment. From non-parametric Hodges-Lehmann estimations.|||0.000|-5.000|0.7214
72457810|NCT02753075|144437933|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.0||||0.896|TWO_SIDED|95.0|-5.0|5.0||Wilcoxon rank sum test.|Wilcoxon rank sum test||Median difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment. From non-parametric Hodges-Lehmann estimations.|||5.000|-5.000|0.8960
72457811|NCT02753075|144437934|SUPERIORITY_OR_OTHER||LS mean difference|0.45||||0.0978|TWO_SIDED|95.0|-0.084|0.987|||ANCOVA||From ANCOVA model with treatment and baseline Schiff stratification as factors and baseline VRS as covariate. Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|||0.987|-0.084|0.0978
72457812|NCT02753075|144437934|SUPERIORITY_OR_OTHER||LS mean difference|0.2||||0.4607|TWO_SIDED|95.0|-0.333|0.732|||ANCOVA||From ANCOVA model with treatment and baseline Schiff stratification as factors and baseline VRS as covariate. Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|||0.732|-0.333|0.4607
72457813|NCT02753075|144437934|SUPERIORITY_OR_OTHER||LS mean difference|0.25||||0.3542|TWO_SIDED|95.0|-0.283|0.787|||ANCOVA||From ANCOVA model with treatment and baseline Schiff stratification as factors and baseline VRS as covariate. Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|||0.787|-0.283|0.3542
72457814|NCT02753075|144437935|SUPERIORITY_OR_OTHER||LS mean difference|0.02||||0.9474|TWO_SIDED|95.0|-0.665|0.711|||ANCOVA||From ANCOVA model with treatment and baseline Schiff stratification as factors and baseline VRS as covariate. Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|||0.711|-0.665|0.9474
72457815|NCT02753075|144437935|SUPERIORITY_OR_OTHER||LS mean difference|-0.09||||0.7987|TWO_SIDED|95.0|-0.76|0.586|||ANCOVA||From ANCOVA model with treatment and baseline Schiff stratification as factors and baseline VRS as covariate. Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|||0.586|-0.760|0.7987
72457816|NCT02753075|144437935|SUPERIORITY_OR_OTHER||LS mean difference|0.11||||0.7525|TWO_SIDED|95.0|-0.578|0.798|||ANCOVA||From ANCOVA model with treatment and baseline Schiff stratification as factors and baseline VRS as covariate. Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|||0.798|-0.578|0.7525
72457817|NCT01102426|144437940|SUPERIORITY||Hazard Ratio (HR)|0.65|||=|0.0054|TWO_SIDED|95.0|0.447|0.885||Cox regression: HR p=0.0062|Log Rank|||||0.885|0.447|=0.0054
72457818|NCT01102426|144437941|SUPERIORITY|||||||0.0618|||||||Normal approximation|||||||0.0618
72457819|NCT01102426|144437942|SUPERIORITY||Hazard Ratio (HR)|0.512|||<|0.0001|TWO_SIDED|95.0|0.382|0.686||Cox regression HR: p\<0.0001|Log Rank|||||0.686|0.382|< 0.0001
72457820|NCT01102426|144437943|SUPERIORITY|||||||0.0002|||||||Normal approximation|||||||0.0002
72457821|NCT01102426|144437944|SUPERIORITY||Hazard Ratio (HR)|0.797|||=|0.1261|TWO_SIDED|95.0|0.596|1.067||Cox regression HR: p=0.1273|Log Rank|||Pre-specified||1.067|0.596|=0.1261
72457822|NCT01102426|144437945|SUPERIORITY|||||||0.3625|||||||Normal approximation|||||||0.3625
72457823|NCT01102426|144437946|SUPERIORITY|||||||0.1037|||||||Normal approximation|||||||0.1037
72457824|NCT01102426|144437947|SUPERIORITY||Hazard Ratio (HR)|0.384|||=|0.1015|TWO_SIDED|95.0|0.113|1.303||Cox regression HR: 0.1247|Log Rank|||||1.303|0.113|=0.1015
72457825|NCT01102426|144437949|SUPERIORITY||Hazard Ratio (HR)|0.043|||=|0.0001|TWO_SIDED|95.0|0.004|0.479||Cox regression HR: 0.0105|Log Rank|||Pre-specified||0.479|0.004|=0.0001
72457826|NCT01102426|144437952|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||||||<0.0001
72457827|NCT01102426|144437953|SUPERIORITY|||||||0.0085|||||||Fisher Exact|||||||0.0085
72620841|NCT01887600|144772758|SUPERIORITY||Least squares mean difference|1.641|||<|0.001|TWO_SIDED|95.0|1.39|1.89||LSM Difference p-value is for test of differences.|Mixed Models Analysis|||Hb change from BL to week 52. A Mixed Model of Repeated Measures was applied. The results were based on the estimated difference between the two treatment arms by visit.The model included treatment arm, region, CV history, visits and visit by treatment as categorical variables and baseline Hb and baseline eGFR as continuous variables.||1.89|1.39|<0.001
72457828|NCT01102426|144437955|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||||||<0.0001
72457829|NCT01102426|144437956|SUPERIORITY|||||||0.0029|||||||Fisher Exact|||||||0.0029
72457830|NCT04405180|144437963|SUPERIORITY||Mean Difference (Net)|0.5|STANDARD_ERROR_OF_MEAN|4.0||0.9017|TWO_SIDED|||||Adjusted for baseline value of outcome as a covariate using general linear (mixed) models and with multiple imputation for missing data|ANCOVA|||||||0.9017
72457831|NCT04405180|144437964|SUPERIORITY||Mean Difference (Net)|0.0342|STANDARD_ERROR_OF_MEAN|0.0417||0.4215|TWO_SIDED||||||ANCOVA|||Adjusted for baseline value of outcome as a covariate using general linear (mixed) models and with multiple imputation for missing data||||0.4215
72457832|NCT04405180|144437965|SUPERIORITY||Mean Difference (Net)|6.0|STANDARD_ERROR_OF_MEAN|53.0||0.9024|TWO_SIDED||||||ANCOVA|||Adjusted for baseline value of outcome as a covariate using general linear (mixed) models and with multiple imputation for missing data||||.9024
72457833|NCT04405180|144437966|SUPERIORITY||Mean Difference (Net)|-59.0|STANDARD_ERROR_OF_MEAN|42.0||0.1646|TWO_SIDED||||||Mixed Models Analysis|||Adjusted for baseline value of outcome as a covariate using general linear (mixed) models and with multiple imputation for missing data||||0.1646
72457834|NCT04405180|144437967|SUPERIORITY||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|1.2||0.9814|TWO_SIDED||||||ANCOVA|||Adjusted for baseline value of outcome as a covariate using general linear (mixed) models and with multiple imputation for missing data||||0.9814
72457835|NCT04405180|144437968|SUPERIORITY||Mean Difference (Net)|0.1|STANDARD_ERROR_OF_MEAN|0.3||0.6217|TWO_SIDED||||||Mixed Models Analysis|||Adjusted for baseline value of outcome as a covariate using general linear (mixed) models and with multiple imputation for missing data||||0.6217
72457836|NCT04405180|144437969|SUPERIORITY||Mean Difference (Net)|-0.1|STANDARD_ERROR_OF_MEAN|0.5||0.7981|TWO_SIDED||||||Mixed Models Analysis|||Adjusted for baseline value of outcome as a covariate using general linear (mixed) models and with multiple imputation for missing data||||0.7981
72457837|NCT04405180|144437970|SUPERIORITY||Mean Difference (Net)|-0.2|STANDARD_ERROR_OF_MEAN|0.4||0.6677|TWO_SIDED||||||Mixed Models Analysis|||Adjusted for baseline value of outcome as a covariate using general linear (mixed) models and with multiple imputation for missing data||||0.6677
72457838|NCT04405180|144437971|SUPERIORITY||Mean Difference (Net)|1.0|STANDARD_ERROR_OF_MEAN|1.1||0.3745|TWO_SIDED||||||Mixed Models Analysis|||Adjusted for baseline value of outcome as a covariate using general linear (mixed) models and with multiple imputation for missing data||||0.3745
72457839|NCT04405180|144437972|SUPERIORITY||Mean Difference (Net)|243.0|STANDARD_ERROR_OF_MEAN|400.0||0.5496|TWO_SIDED||||||ANCOVA|||Adjusted for baseline value of outcome as a covariate using general linear (mixed) models and with multiple imputation for missing data||||0.5496
72457840|NCT03265132|144437994|SUPERIORITY||Risk Difference (RD)|1.0||||0.0022|TWO_SIDED|95.0|0.42|1.0|||Fisher Exact|||||1.00|0.42|0.0022
72457841|NCT01137682|144438044|SUPERIORITY||Odds Ratio (OR)|16.63||||0.0006|TWO_SIDED|95.0|3.32||infinity||Regression, Logistic|An exact logistic regression model that adjusts for the randomization stratification factors was used to test the null hypothesis.|||||3.32|0.0006
72457842|NCT01137682|144438044|SUPERIORITY||Odds Ratio (OR)|23.03|||<|0.0001|TWO_SIDED|95.0|4.72||infinity||Regression, Logistic|An exact logistic regression model that adjusts for the randomization stratification factors was used to test the null hypothesis.|||||4.72|<0.0001
72457843|NCT00244751|144438068|SUPERIORITY_OR_OTHER|||||||0.3608|||||||reduced regression model|||||||0.3608
72457844|NCT00244751|144438068|SUPERIORITY_OR_OTHER|||||||0.3575|||||||reduced regression model|||||||0.3575
72457845|NCT00244751|144438069|SUPERIORITY_OR_OTHER|||||||0.9157|||||||reduced regression model|||||||0.9157
72457846|NCT00244751|144438069|SUPERIORITY_OR_OTHER|||||||0.9501|||||||reduced regression model|||||||0.9501
72457847|NCT00244751|144438070|SUPERIORITY_OR_OTHER|||||||0.6483|||||||Cochran-Mantel-Haenszel Test|||Comparison for Ranked assessment (fibrosis)||||0.6483
72457848|NCT00244751|144438070|SUPERIORITY_OR_OTHER|||||||0.1776|||||||Cochran-Mantel-Haenszel Test|||Comparison for Ranked assessment (necrosis)||||0.1776
72457849|NCT01262456|144438097|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.41|||<|0.0001|TWO_SIDED|95.0|-0.61|-0.22||A priori threshold for significance was p\<=0.05.|ANCOVA|Repeated measures ANCOVA of change from baseline at Week 1, Months 1, 2, 3, adjusted for age (\<65, ≥65 years), visit, and baseline nocturnal voids.||"Superiority to placebo was to be simultaneously demonstrated on the 2 co-primary outcomes in a step-down approach from highest (75 μg) to lowest dose (50 μg), thereby controlling the family-wise error rate at the 5% nominal significance level.~A summary of mean change in nocturnal voids, assessed longitudinally during 3 months of treatment, is presented below for the FAS using LOCF."||-0.22|-0.61|<0.0001
72457850|NCT01262456|144438097|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.37||||0.0003|TWO_SIDED|95.0|-0.57|-0.17||A priori threshold for significance was p\<=0.05|ANCOVA|Repeated measures ANCOVA of change from baseline at Week 1, Months 1, 2, 3, adjusted for age (\<65, ≥65 years), visit, and baseline nocturnal voids.||"Superiority to placebo was to be simultaneously demonstrated on the 2 co-primary outcomes in a step-down approach from highest (75 μg) to lowest dose (50 μg), thereby controlling the family-wise error rate at the 5% nominal significance level.~A summary of mean change in nocturnal voids, assessed longitudinally during 3 months of treatment, is presented below for the FAS using LOCF."||-0.17|-0.57|0.0003
72457851|NCT01262456|144438098|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.04||||0.0004|TWO_SIDED|95.0|1.38|3.03||A priori threshold for significance was p\<=0.05.|Generalized Estimating Equation (GEE)|GEE Method for 33% responder status at Week 1, Month 1, Month 2, and Month 3, adjusted for age (\<65, ≥65 years), visit, and baseline nocturnal voids.||Superiority to placebo was to be simultaneously demonstrated on the 2 co-primary endpoints in a step-down approach from highest (75 μg) to lowest dose (50 μg), thereby controlling the family-wise error rate at the 5% nominal significance level.||3.03|1.38|0.0004
72457852|NCT01262456|144438098|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.98||||0.0009|TWO_SIDED|95.0|1.32|2.96||A priori threshold for significance was p\<=0.05.|Generalized Estimating Equation (GEE)|GEE Method for 33% responder status at Week 1, Month 1, Month 2, and Month 3, adjusted for age (\<65, ≥65 years), visit, and baseline nocturnal voids.||Superiority to placebo was to be simultaneously demonstrated on the 2 co-primary endpoints in a step-down approach from highest (75 μg) to lowest dose (50 μg), thereby controlling the family-wise error rate at the 5% nominal significance level.||2.96|1.32|0.0009
72457853|NCT01262456|144438099|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.35||||0.0029|TWO_SIDED|95.0|-0.57|-0.12||A priori threshold for significance was p\<=0.05.|ANCOVA|ANCOVA of change from baseline adjusted for age (\<65, \>=65) and baseline nocturnal voids using last observation carried forward.||"Change from baseline in the adjusted mean number of nocturnal voids in the FAS using LOCF.~The active treatment groups were compared to placebo using a step-down approach from highest dose (75 µg) to lowest dose (50 µg)."||-0.12|-0.57|0.0029
72457854|NCT01262456|144438099|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.29||||0.0128|TWO_SIDED|95.0|-0.52|-0.06||A priori threshold for significance was p\<=0.05.|ANCOVA|ANCOVA of change from baseline adjusted for age (\<65, \>=65) and baseline nocturnal voids.||"Change from baseline in the adjusted mean number of nocturnal voids in the FAS using LOCF.~The active treatment groups were compared to placebo using a step-down approach from highest dose (75 µg) to lowest dose (50 µg)."||-0.06|-0.52|0.0128
72457855|NCT01262456|144438100|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.81||||0.0233|TWO_SIDED|95.0|1.08|3.02||A priori threshold for significance was p\<=0.05.|Regression, Logistic|Logistical regression of 33% responder status adjusted for age (\<65, \>=65) and baseline nocturnal voids using last observation carried forward.||The active treatment groups were compared to placebo using a step-down approach from highest dose (75 µg) to lowest dose (50 µg).||3.02|1.08|0.0233
72457856|NCT01262456|144438100|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.72||||0.0386|TWO_SIDED|95.0|1.03|2.87||A priori threshold for significance was p\<=0.05.|Regression, Logistic|Logistical regression of 33% responder status adjusted for age (\<65, \>=65) and baseline nocturnal voids using last observation carried forward.||The active treatment groups were compared to placebo using a step-down approach from highest dose (75 µg) to lowest dose (50 µg).||2.87|1.03|0.0386
72457857|NCT01262456|144438101|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|42.76||||0.0026|TWO_SIDED|95.0|15.02|70.51||A priori threshold for significance was p\<=0.05.|ANCOVA|ANCOVA of change from baseline adjusted for age (\<65, \>=65) and baseline time to first nocturnal void using last observation carried forward.||The active treatment groups were compared to placebo using a step-down approach from highest dose (75 µg) to lowest dose (50 µg).||70.51|15.02|0.0026
72457858|NCT01262456|144438101|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|38.95||||0.0064|TWO_SIDED|95.0|11.03|66.88||A priori threshold for significance was p\<=0.05.|ANCOVA|ANCOVA of change from baseline adjusted for age (\<65, \>=65) and baseline time to first nocturnal void using last observation carried forward.||The active treatment groups were compared to placebo using a step-down approach from highest dose (75 µg) to lowest dose (50 µg).||66.88|11.03|0.0064
72457859|NCT01262456|144438102|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-86.17||||0.0034|TWO_SIDED|95.0|-143.69|-28.64||A priori threshold for significance was p\<=0.05.|ANCOVA|ANCOVA of change from baseline adjusted for age (\<65, \>=65) and baseline nocturnal urine volume using last observation carried forward.||The active treatment groups were compared to placebo using a step-down approach from highest dose (75 µg) to lowest dose (50 µg).||-28.64|-143.69|0.0034
72457860|NCT01262456|144438102|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-77.8||||0.0086|TWO_SIDED|95.0|-135.7|-19.89||A priori threshold for significance was p\<=0.05.|ANCOVA|ANCOVA of change from baseline adjusted for age (\<65, \>=65) and baseline nocturnal urine volume using last observation carried forward.||The active treatment groups were compared to placebo using a step-down approach from highest dose (75 µg) to lowest dose (50 µg).||-19.89|-135.70|0.0086
72457861|NCT01262456|144438103|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-45.31||||0.4126|TWO_SIDED|95.0|-153.94|63.32||A priori threshold for significance was p\<=0.05.|ANCOVA|ANCOVA of change from baseline adjusted for age (\<65, \>=65) and baseline 24-hour urine volume using last observation carried forward.||The active treatment groups were compared to placebo using a step-down approach from highest dose (75 µg) to lowest dose (50 µg).||63.32|-153.94|0.4126
72457862|NCT01262456|144438103|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-18.79||||0.7353|TWO_SIDED|95.0|-127.99|90.41||A priori threshold for significance was p\<=0.05.|ANCOVA|ANCOVA of change from baseline adjusted for age (\<65, \>=65) and baseline 24-hour urine volume using last observation carried forward.||The active treatment groups were compared to placebo using a step-down approach from highest dose (75 µg) to lowest dose (50 µg).||90.41|-127.99|0.7353
72457863|NCT02516202|144438113|SUPERIORITY|||||||0.25||||||P-values from active treatment vs. placebo contrasts in a repeated measures linear model of outcome as a function of treatment arm, clinical site, week, and baseline outcome. The a priori threshold for statistical significance was 0.025.|Regression, Linear|Robust standard errors were calculated using generalized estimating equations to account for within-participant correlation between repeated measures||||||0.25
72457864|NCT02516202|144438113|SUPERIORITY|||||||0.31||||||P-values from active treatment vs. placebo contrasts in a repeated measures linear model of outcome as a function of treatment arm, clinical site, week, and baseline outcome. The a priori threshold for statistical significance was 0.025|Regression, Linear|Robust standard errors were calculated using generalized estimating equations to account for within-participant correlation between repeated measures||||||0.31
72457865|NCT02516202|144438114|SUPERIORITY|||||||0.99||||||P-values from active treatment vs. placebo contrasts in a repeated measures linear model of outcome as a function of treatment arm, clinical site, week, and baseline outcome. The a priori threshold for statistical significance was 0.025.|Regression, Linear|Robust standard errors were calculated using generalized estimating equations to account for within-participant correlation between repeated measures||||||0.99
72457866|NCT02516202|144438114|SUPERIORITY|||||||0.05||||||P-values from active treatment vs. placebo contrasts in a repeated measures linear model of outcome as a function of treatment arm, clinical site, week, and baseline outcome. The a priori threshold for statistical significance was 0.025.|Regression, Linear|Robust standard errors were calculated using generalized estimating equations to account for within-participant correlation between repeated measures||||||0.05
72457867|NCT02516202|144438115|SUPERIORITY|||||||0.64||||||P-values from active treatment vs. placebo contrasts in a repeated measures linear model of outcome as a function of treatment arm, clinical site, week, and baseline outcome. The a priori threshold for statistical significance was 0.025.|Regression, Linear|Robust standard errors were calculated using generalized estimating equations to account for within-participant correlation between repeated measures||||||0.64
72457868|NCT02516202|144438115|SUPERIORITY|||||||0.17||||||P-values from active treatment vs. placebo contrasts in a repeated measures linear model of outcome as a function of treatment arm, clinical site, week, and baseline outcome. The a priori threshold for statistical significance was 0.025.|Regression, Linear|Robust standard errors were calculated using generalized estimating equations to account for within-participant correlation between repeated measures||||||0.17
72457869|NCT02516202|144438117|SUPERIORITY|||||||0.02||||||p-value calculation includes 195 participants with known responses at week 12.|Chi-squared|||||||0.02
72457870|NCT02516202|144438118|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
72457871|NCT02516202|144438118|SUPERIORITY|||||||0.6|||||||Chi-squared|||||||0.60
72457872|NCT02516202|144438119|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
72457873|NCT02516202|144438119|SUPERIORITY|||||||0.95|||||||Chi-squared|||||||0.95
72457874|NCT00337610|144438120|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.02|STANDARD_DEVIATION|1.19|<|0.001||95.0|-1.36|-0.67|||ANCOVA|Model terms: treatment; baseline; prior anti-hyperglycemic agent (AHA) \[medication\] (on Monotherapy AHA or on Metformin-based combination therapy)||||-0.67|-1.36|<0.001
72457875|NCT00337610|144438121|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-25.5|STANDARD_DEVIATION|42.2|<|0.001||95.0|-37.7|-13.3|||ANCOVA|Model terms: treatment; baseline; prior anti-hyperglycemic medication (on Monotherapy AHA or on Metformin-based combination therapy)||||-13.3|-37.7|<0.001
72457876|NCT00337610|144438122|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-54.1|STANDARD_DEVIATION|63.8|<|0.001||95.0|-74.7|-33.6|||ANCOVA|Model terms: treatment; baseline; prior anti-hyperglycemic medication (on Monotherapy AHA or on Metformin-based combination therapy)||||-33.6|-74.7|<0.001
72457877|NCT00337610|144438123|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.01|STANDARD_DEVIATION|1.34|<|0.001||95.0|-1.4|-0.62|||ANCOVA|Model terms: treatment; baseline; prior anti-hyperglycemic medication (on Monotherapy AHA or on Metformin-based combination therapy)||||-0.62|-1.40|<0.001
72457878|NCT04012970|144438127|SUPERIORITY||||||<|0.05|||||||ANOVA|2-way, repeated measures||||||<0.05
72457879|NCT04012970|144438127|SUPERIORITY||||||<|0.01|||||||ANCOVA|||Stiffness change ran with covariates (baseline stiffness, BMI, ODI, waist circumference, height and gender).||||<0.01
72457880|NCT04012970|144438128|SUPERIORITY||||||<|0.01|||||||ANOVA|2-way, repeated measures||||||<0.01
72457881|NCT04012970|144438128|SUPERIORITY||||||<|0.01|||||||ANCOVA|||Stiffness change ran with covariates (baseline stiffness, BMI, ODI, waist circumference, height and gender).||||<0.01
72500346|NCT03193866|144530966|SUPERIORITY||Difference in proportion|-33.9|||||TWO_SIDED|95.0|-39.8|-28.0||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||-28.0|-39.8|
72457882|NCT04012970|144438129|SUPERIORITY||||||<|0.01|||||||ANOVA|2-way, repeated measures||||||<0.01
72457883|NCT04012970|144438129|SUPERIORITY||||||<|0.05|||||||ANCOVA|||Tone change ran with covariates (baseline stiffness, BMI, ODI, waist circumference, height and gender).||||<0.05
72457884|NCT04012970|144438130|SUPERIORITY||||||<|0.01|||||||ANOVA|2-way, repeated measures||||||<0.01
72457885|NCT04012970|144438130|SUPERIORITY||||||<|0.05|||||||ANCOVA|||Tone change ran with covariates (baseline stiffness, BMI, ODI, waist circumference, height and gender).||||<0.05
72457886|NCT04012970|144438131|SUPERIORITY||||||<|0.01|||||||ANOVA|2-way, repeated measures||||||<0.01
72457887|NCT04012970|144438132|SUPERIORITY||||||<|0.001|||||||ANOVA|2-way, repeated measures||||||<0.001
72457888|NCT04867382|144438139|SUPERIORITY||Mean Difference (Final Values)|-0.13|STANDARD_ERROR_OF_MEAN|0.27||0.63|TWO_SIDED||||||t-test, 2 sided|||||||.63
72457889|NCT04867382|144438140|SUPERIORITY||Mean Difference (Final Values)|0.19|STANDARD_ERROR_OF_MEAN|0.17||0.27|TWO_SIDED||||||t-test, 2 sided|||||||0.27
72457890|NCT04867382|144438141|SUPERIORITY||Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|0.22||0.37|TWO_SIDED||||||t-test, 2 sided|||||||.37
72457891|NCT04867382|144438142|SUPERIORITY||Odds Ratio (OR)|1.75||||0.12|TWO_SIDED|95.0|0.86|3.57|||Regression, Logistic|||||3.57|0.86|.12
72457892|NCT01326455|144438143|SUPERIORITY_OR_OTHER_LEGACY|||||||0.25|TWO_SIDED|95.0|||||Chi-squared|||Lancaster et. al. (2004) quoted the number 30 as a general sample size for a pilot study. Each arm of this study had 25 people (due to time constraints), giving a total of 75 people. The data were analyzed using t-tests for equality of means, a two-way analysis of variance (ANOVA), and chi-square. Significance was set at p \< 0.05.||||0.25
72457893|NCT01326455|144438144|SUPERIORITY_OR_OTHER_LEGACY|||||||0.47|||||||Chi-squared|||||||0.47
72457894|NCT01326455|144438145|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002|TWO_SIDED|95.0|||||ANOVA|||||||0.002
72457895|NCT01326455|144438145|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||ANOVA|||||||<0.001
72457896|NCT01326455|144438145|SUPERIORITY_OR_OTHER_LEGACY|||||||0.144|||||||ANOVA|||||||0.144
72457897|NCT01326455|144438146|SUPERIORITY_OR_OTHER_LEGACY|||||||0.372|||||||ANOVA|||||||0.372
72457898|NCT01326455|144438147|SUPERIORITY_OR_OTHER_LEGACY|||||||0.468|||||||Chi-squared|||||||0.468
72457899|NCT02008916|144438156|SUPERIORITY||Odds Ratio (OR)|2.41||||0.0093|TWO_SIDED|95.0|1.24|4.69|||Regression, Logistic|||||4.69|1.24|0.0093
72457900|NCT02008916|144438156|SUPERIORITY||Odds Ratio (OR)|2.68||||0.0037|TWO_SIDED|95.0|1.38|5.21|||Regression, Logistic|||||5.21|1.38|0.0037
72457901|NCT02008916|144438157|SUPERIORITY||Odds Ratio (OR)|2.59||||0.01|TWO_SIDED|95.0|1.26|5.35|||Regression, Logistic|||||5.35|1.26|0.0100
72457902|NCT02008916|144438157|SUPERIORITY||Odds Ratio (OR)|2.81||||0.0051|TWO_SIDED|95.0|1.36|5.78|||Regression, Logistic|||||5.78|1.36|0.0051
72457903|NCT02008916|144438158|SUPERIORITY||Relative treatment effect|0.51|||<|0.0001|TWO_SIDED|95.0|0.38|0.68|||Mixed Models Analysis||Relative treatment effect = exponential of the difference in LSM on the log e scale or the geometric LSM ratio on the original scale. For values less than 1, AIN457 has a greater reduction than Placebo.|||0.68|0.38|<0.0001
72457904|NCT02008916|144438158|SUPERIORITY||Relative treatment effect|0.44|||<|0.0001|TWO_SIDED|95.0|0.33|0.6|||Mixed Models Analysis||Relative treatment effect = exponential of the difference in LSM on the log e scale or the geometric LSM ratio on the original scale. For values less than 1, AIN457 has a greater reduction than Placebo.|||0.60|0.33|<0.0001
72457905|NCT02008916|144438159|SUPERIORITY||Odds Ratio (OR)|4.46||||0.0002|TWO_SIDED|95.0|2.01|9.92|||Regression, Logistic|||||9.92|2.01|0.0002
72457906|NCT02008916|144438159|SUPERIORITY||Odds Ratio (OR)|4.21||||0.0004|TWO_SIDED|95.0|1.89|9.38|||Regression, Logistic|||||9.38|1.89|0.0004
72457907|NCT02008916|144438160|SUPERIORITY||Mean Difference (Final Values)|-0.83|STANDARD_ERROR_OF_MEAN|0.39||0.0347|TWO_SIDED|95.0|-1.6|-0.06|||Mixed Models Analysis|||||-0.06|-1.60|0.0347
72457908|NCT02008916|144438160|SUPERIORITY||Mean Difference (Final Values)|-1.23|STANDARD_ERROR_OF_MEAN|0.39||0.0018|TWO_SIDED|95.0|-2.0|-0.46|||Mixed Models Analysis|||||-0.46|-2.00|0.0018
72457909|NCT02008916|144438164|SUPERIORITY||Odds Ratio (OR)|7.71||||0.0593|TWO_SIDED|95.0|0.92|64.42|||Regression, Logistic|||||64.42|0.92|0.0593
72457910|NCT02008916|144438164|SUPERIORITY||Odds Ratio (OR)|19.39||||0.0046|TWO_SIDED|95.0|2.49|150.79|||Regression, Logistic|||||150.79|2.49|0.0046
72457911|NCT01079949|144438199|SUPERIORITY_OR_OTHER|||||||0.5739||95.0|||||Wilcoxon two sample test|||||||0.5739
72457912|NCT01079949|144438204|SUPERIORITY_OR_OTHER|||||||0.1734||95.0|||||Wilcoxon two sample test|||||||0.1734
72457913|NCT01079949|144438205|SUPERIORITY_OR_OTHER|||||||0.0642||95.0|||||Wilcoxon two sample test|||||||0.0642
72457914|NCT01079949|144438209|SUPERIORITY_OR_OTHER|||||||0.408||95.0|||||Wilcoxon two sample test|||||||0.4080
72457915|NCT01079949|144438212|SUPERIORITY_OR_OTHER|||||||0.0648||95.0|||||Wilcoxon two sample test|||||||0.0648
72457916|NCT01079949|144438213|SUPERIORITY_OR_OTHER|||||||0.6799||95.0|||||ANOVA|||||||0.6799
72457917|NCT01079949|144438214|SUPERIORITY_OR_OTHER|||||||0.0634||95.0|||||Wilcoxon two sample test|||||||0.0634
72457918|NCT01079949|144438216|SUPERIORITY_OR_OTHER|||||||0.0166||95.0|||||Wilcoxon two sample test|||||||0.0166
72457919|NCT01079949|144438217|SUPERIORITY_OR_OTHER|||||||0.8812||95.0|||||ANOVA|||||||0.8812
72457920|NCT02144285|144438221|SUPERIORITY_OR_OTHER||Absolute Bioavailability|0.45|||||TWO_SIDED|90.0|0.34|0.6||||||||0.60|0.34|
72457921|NCT03786471|144438238|SUPERIORITY||marginal difference of LS means|0.3||||0.33|TWO_SIDED|97.5|-0.18|0.78||Alpha = 0.025; Hochberg correction for three pairwise comparisons|Mixed Models Analysis|||||0.78|-0.18|0.33
72457922|NCT03786471|144438238|SUPERIORITY||marginal difference of LS means|-0.62||||0.33|TWO_SIDED|97.5|-1.61|0.37||Alpha = 0.025; Hochberg correction for three pairwise comparisons|Mixed Models Analysis|||||0.37|-1.61|0.33
72457923|NCT03786471|144438238|SUPERIORITY||marginal difference of LS means|-0.33||||0.46|TWO_SIDED|97.5|-1.32|0.67||Alpha = 0.025; Hochberg correction for three pairwise comparisons|Mixed Models Analysis|||||0.67|-1.32|0.46
72457924|NCT03786471|144438245|SUPERIORITY||marginal difference of LS means|0.25||||0.54|TWO_SIDED|97.5|-0.16|0.66||Alpha = 0.025; Hochberg correction for three pairwise comparisons|Mixed Models Analysis|||||0.66|-0.16|0.54
72457925|NCT03786471|144438245|SUPERIORITY||marginal difference of LS means|-0.1||||0.79|TWO_SIDED|97.5|-0.94|0.74||Alpha = 0.025; Hochberg correction for three pairwise comparisons|Mixed Models Analysis|||||0.74|-0.94|0.79
72457926|NCT03786471|144438245|SUPERIORITY||marginal difference of LS means|0.14||||0.79|TWO_SIDED|97.5|-0.7|0.99||Alpha = 0.025; Hochberg correction for three pairwise comparisons|Mixed Models Analysis|||||0.99|-0.70|0.79
72457927|NCT03786471|144438252|SUPERIORITY||marginal difference of LS means|0.52||||0.48|TWO_SIDED|95.0|-0.09|1.13||Alpha = 0.05; Hochberg correction for three pairwise comparisons \* three secondary outcomes|Mixed Models Analysis|||||1.13|-.09|0.48
72457928|NCT03786471|144438252|SUPERIORITY||marginal difference of LS means|-0.81||||0.62|TWO_SIDED|95.0|-2.07|0.45||Alpha = 0.05; Hochberg correction for three pairwise comparisons \*three secondary outcomes|Mixed Models Analysis|||||0.45|-2.07|0.62
72457929|NCT03786471|144438252|SUPERIORITY||marginal difference of LS means|-1.33||||0.23|TWO_SIDED|95.0|-2.58|-0.07||Alpha = 0.05; Hochberg correction for three pairwise comparisons \* three secondary outcomes|Mixed Models Analysis|||||-0.07|-2.58|0.23
72457930|NCT03786471|144438259|SUPERIORITY||marginal difference of LS means|0.28||||0.23|TWO_SIDED|95.0|0.01|0.54||Alpha = 0.05; Hochberg correction for three pairwise comparisons \* three secondary outcomes|Mixed Models Analysis|||||.54|.01|0.23
72457931|NCT03786471|144438259|SUPERIORITY||marginal difference of LS means|0.01||||0.98|TWO_SIDED|95.0|-0.53|0.55||Alpha = 0.05; Hochberg correction for three pairwise comparisons \*three secondary outcomes|Mixed Models Analysis|||||.55|-.53|.98
72457932|NCT03786471|144438259|SUPERIORITY||marginal difference of LS means|-0.27||||0.65|TWO_SIDED|95.0|-0.81|0.27||Alpha = 0.05; Hochberg correction for three pairwise comparisons \* three secondary outcomes|Mixed Models Analysis|||||0.27|-0.81|0.65
72457933|NCT03786471|144438264|SUPERIORITY||marginal difference of LS means|-0.16||||0.62|TWO_SIDED|95.0|-0.37|0.06||Alpha = 0.05; Hochberg correction for three pairwise comparisons \* three secondary outcomes|Mixed Models Analysis|||||0.06|-0.37|0.62
72457934|NCT03786471|144438264|SUPERIORITY||marginal difference of LS means|0.7||||0.01|TWO_SIDED|95.0|0.26|1.14||Alpha = 0.05; Hochberg correction for three pairwise comparisons \* three secondary outcomes|Mixed Models Analysis|||||1.14|0.26|0.01
72457935|NCT03786471|144438264|SUPERIORITY||marginal difference of LS means|0.85||||0.001|TWO_SIDED|95.0|0.42|1.29||Alpha = 0.05; Hochberg correction for three pairwise comparisons \* three secondary outcomes|Mixed Models Analysis|||||1.29|0.42|0.001
72457936|NCT03346200|144438287|NON_INFERIORITY|The non-inferiority margin was based on the proportion of responders and was set to 17%. That is, we defined non-inferiority to mean that the proportion of responders in the non-referent study arms is not less than one third of the responders in the 20 mg group (50% minus 33% = 17%)|Median Difference (Final Values)|52.5|||<|0.01|TWO_SIDED|97.5|41.9|100.0|||one-sided Wald tests|P-values were corrected for multiple comparisons using the Holm-Bonferroni method. Non-inferiority p-values were declared if less than a=0.025||||100|41.9|<0.01
72457937|NCT01513447|144438300|SUPERIORITY_OR_OTHER|||||||0.67|TWO_SIDED||||||Fisher Exact|||||||0.67
72457938|NCT01513447|144438301|SUPERIORITY_OR_OTHER||Mean Difference (Net)|102.0||||0.29|TWO_SIDED|95.0|-230.0|171.0|||Wilcoxon (Mann-Whitney)|||||171|-230|0.29
72500347|NCT03193866|144530966|SUPERIORITY||Difference in proportion|-33.9|||||TWO_SIDED|95.0|-39.7|-28.0||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||-28.0|-39.7|
72500348|NCT03193866|144530966|SUPERIORITY||Difference in proportion|-49.8|||||TWO_SIDED|95.0|-58.0|-41.6||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||-41.6|-58.0|
72392472|NCT01233258|144292284|SUPERIORITY_OR_OTHER|||||||0.0001||||||No multiplicity adjustment as only 1 primary endpoint.|ANOVA|No adjustment, no transformation of data seemed to be necessary.||Null hypothesis: bleeding rates are equal, alternative hypothesis rates are unequal. Power calculation: Assumption 5 bleeds per year on prophylactic treatment, 15 on on-demand treatment; 2-sided alpha 5% and 90% power.||||0.0001
72392473|NCT01233258|144292285|SUPERIORITY_OR_OTHER|||||||0.0001||||||No multiplicity adjustment as this is not primary endpoint.|ANOVA|No adjustment, no transformation of data seemed to be necessary.||Null hypothesis: bleeding rates are equal, alternative hypothesis rates are unequal. Power calculation not done for this comparison as not primary comparison.||||0.0001
72457939|NCT01276509|144438302|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentage|0.05|STANDARD_ERROR_OF_MEAN|0.121||0.3393|TWO_SIDED|90.0|-0.149|0.249|||Mixed Models Analysis|||Difference from placebo at Week 8||0.249|-0.149|0.3393
72457940|NCT01276509|144438302|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentage|0.124|STANDARD_ERROR_OF_MEAN|0.117||0.1433|TWO_SIDED|90.0|-0.068|0.316|||Mixed Models Analysis|||Difference from placebo at Week 8||0.316|-0.068|0.1433
72457941|NCT01276509|144438302|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentage|0.15|STANDARD_ERROR_OF_MEAN|0.113||0.0922|TWO_SIDED|90.0|-0.036|0.335|||Mixed Models Analysis|||Difference from placebo at Week 8||0.335|-0.036|0.0922
72457942|NCT01276509|144438302|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentage|0.034|STANDARD_ERROR_OF_MEAN|0.117||0.3864|TWO_SIDED|90.0|-0.158|0.225|||Mixed Models Analysis|||Difference from placebo at Week 12||0.225|-0.158|0.3864
72457943|NCT01276509|144438302|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentage|0.061|STANDARD_ERROR_OF_MEAN|0.117||0.3005|TWO_SIDED|90.0|-0.131|0.253|||Mixed Models Analysis|||Difference from placebo at Week 12||0.253|-0.131|0.3005
72457944|NCT01276509|144438302|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentage|-0.011|STANDARD_ERROR_OF_MEAN|0.114||0.5385|TWO_SIDED|90.0|-0.198|0.176|||Mixed Models Analysis|||Difference from placebo at Week 12||0.176|-0.198|0.5385
72457945|NCT01276509|144438305|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentage|0.124|STANDARD_ERROR_OF_MEAN|0.107||0.1234|TWO_SIDED|90.0|-0.052|0.299|||Mixed Models Analysis|||Difference from placebo at week 8||0.299|-0.052|0.1234
72457946|NCT01276509|144438305|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentage|0.071|STANDARD_ERROR_OF_MEAN|0.099||0.2378|TWO_SIDED|90.0|-0.092|0.234|||Mixed Models Analysis|||Difference from placebo at week 8||0.234|-0.092|0.2378
72457947|NCT01276509|144438305|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentage|0.102|STANDARD_ERROR_OF_MEAN|0.1||0.1529|TWO_SIDED|90.0|-0.062|0.266|||Mixed Models Analysis|||Difference from placebo at week 8||0.266|-0.062|0.1529
72457948|NCT01276509|144438305|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentage|0.038|STANDARD_ERROR_OF_MEAN|0.112||0.3661|TWO_SIDED|90.0|-0.146|0.222|||Mixed Models Analysis|||Difference from placebo at week 12||0.222|-0.146|0.3661
72457949|NCT01276509|144438305|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentage|0.055|STANDARD_ERROR_OF_MEAN|0.116||0.3169|TWO_SIDED|90.0|-0.136|0.246|||Mixed Models Analysis|||Difference from placebo at week 12||0.246|-0.136|0.3169
72457950|NCT01276509|144438305|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentage|0.066|STANDARD_ERROR_OF_MEAN|0.111||0.2755|TWO_SIDED|90.0|-0.116|0.248|||Mixed Models Analysis|||Difference from placebo at week 12||0.248|-0.116|0.2755
72457951|NCT03854734|144438316|SUPERIORITY|Generalized estimating equations (GEE) model using the framework of a log-binomial logistic regression model.|Risk Ratio (RR)|1.12|||||TWO_SIDED|95.0|1.0|1.25|||Regression, Logistic|||Analysis for vaccine intention of Tdap||1.25|1.00|
72457952|NCT03854734|144438316|SUPERIORITY|Generalized estimating equations (GEE) model using the framework of a log-binomial logistic regression model.|Risk Ratio (RR)|1.14|||||TWO_SIDED|95.0|1.0|1.29|||Regression, Logistic|||Analysis for vaccine intention of MCV||1.29|1.00|
72457953|NCT03854734|144438316|SUPERIORITY|Generalized estimating equations (GEE) model using the framework of a log-binomial logistic regression model.|Risk Ratio (RR)|1.05|||||TWO_SIDED|95.0|0.96|1.14|||Regression, Logistic|||Analysis for vaccine intention of HPV||1.14|0.96|
72457954|NCT02935673|144438378|SUPERIORITY||AUC(1-7) difference vs (pooled) placebo|-0.32|||||TWO_SIDED|95.0|-0.89|0.24|||||||Mixed model for repeated measures, using all available viral load data of baseline and up to and including Day 7, taking missing data into account under the missing at random assumption.|0.24|-0.89|
72457955|NCT02935673|144438378|SUPERIORITY||AUC(1-7) difference vs (pooled) placebo|-0.36|||||TWO_SIDED|95.0|-1.33|0.62|||||||Mixed model for repeated measures, using all available viral load data of baseline and up to and including Day 7, taking missing data into account under the missing at random assumption.|0.62|-1.33|
72457956|NCT04471805|144438485|SUPERIORITY||||||<|0.05||||||Post hoc analyses (paired t-tests and Bonferroni correction) and effect size (Cohen's d) were calculated to clarify significant main effects and interactions.|ANOVA|Normality and sphericity evaluated with Shapiro-Wilk test and Mauchly's test. Greenhouse-Geisser corrections used when sphericity was violated.||||||<0.05
72457957|NCT04471805|144438486|SUPERIORITY||||||<|0.05||||||Post hoc analyses (paired t-tests and Bonferroni correction) and effect size (Cohen's d) were calculated to clarify significant main effects and interactions.|ANOVA|Normality and sphericity evaluated with Shapiro-Wilk test and Mauchly's test. Greenhouse-Geisser corrections used when sphericity was violated.||||||<0.05
72457958|NCT01163214|144438488|SUPERIORITY_OR_OTHER|||||||0.78|TWO_SIDED||||||t-test, 2 sided|||||||0.78
72457959|NCT01163214|144438488|SUPERIORITY_OR_OTHER|||||||0.58|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.58
72457960|NCT01163214|144438489|SUPERIORITY_OR_OTHER|||||||0.76|TWO_SIDED||||||t-test, 2 sided|||||||0.76
72457961|NCT01163214|144438489|SUPERIORITY_OR_OTHER|||||||0.59|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.59
72563029|NCT00292227|144658107|SUPERIORITY_OR_OTHER||Mean Difference (Net)|13.5||||||95.0|11.78|15.22|||ANOVA|The ANOVA model included the factors treatment, period, sequence, and subject(sequence).|The direction of the estimate is Moxifloxacin - Placebo. Mean difference was estimated from the ANOVA model.|For the analysis of the assay sensitivity, an ANOVA with the factors treatment, period, sequence, and subject(sequence) for comparison of moxifloxacin vs placebo (cross-over comparison) was performed. The point estimates for the difference between placebo and positive control (moxifloxacin) and the respective 95% confidence intervals were calculated.||15.22|11.78|
72457962|NCT01163214|144438490|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||t-test, 2 sided|||Comparison of arms for intraoperative narcotic use.||||<0.001
72457963|NCT01163214|144438490|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||t-test, 2 sided|||Comparison of arms for narcotic use on day of surgery as needed.||||<0.001
72457964|NCT01163214|144438490|SUPERIORITY_OR_OTHER|||||||0.17|TWO_SIDED||||||t-test, 2 sided|||Comparison of arms for narcotic use on post operative day 1 as needed.||||0.17
72457965|NCT01163214|144438490|SUPERIORITY_OR_OTHER|||||||0.51|TWO_SIDED||||||t-test, 2 sided|||Comparison of arms for narcotic use on post operative day 2 as needed.||||0.51
72457966|NCT01163214|144438491|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||t-test, 2 sided|||Comparison between arms for postoperative day 1 morning.||||<0.001
72457967|NCT01163214|144438491|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||t-test, 2 sided|||Comparison between arms for postoperative day 1 afternoon.||||<0.001
72457968|NCT01163214|144438491|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED||||||t-test, 2 sided|||Comparison between arms for postoperative day 2 morning.||||0.002
72457969|NCT01163214|144438491|SUPERIORITY_OR_OTHER|||||||0.97|TWO_SIDED||||||t-test, 2 sided|||Comparison between arms for postoperative day 2 afternoon.||||0.97
72457970|NCT01163214|144438492|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED||||||t-test, 2 sided|||Comparison between the arms for length of stay in the hospital.||||0.02
72457971|NCT01163214|144438493|SUPERIORITY_OR_OTHER|||||||0.49|TWO_SIDED||||||t-test, 2 sided|||Comparison between arms for femoral nerve.||||0.49
72457972|NCT01163214|144438493|SUPERIORITY_OR_OTHER|||||||0.01|TWO_SIDED||||||t-test, 2 sided|||Comparison between arms for common peroneal nerve.||||0.01
72457973|NCT01163214|144438493|SUPERIORITY_OR_OTHER|||||||0.62|TWO_SIDED||||||t-test, 2 sided|||Comparison between arms for tibial nerve.||||0.62
72457974|NCT01163214|144438493|SUPERIORITY_OR_OTHER|||||||0.009|TWO_SIDED||||||t-test, 2 sided|||Comparison between arms for femoral, peroneal, or tibial nerves.||||0.009
72457975|NCT01393964|144438497|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|104.096||||0.704|TWO_SIDED|90.0|86.983|124.576|||ANOVA|||The reference arm is NRF participants.||124.576|86.983|0.704
72457976|NCT01393964|144438497|SUPERIORITY_OR_OTHER||ratio of adjusted means|100.454||||0.965|TWO_SIDED|90.0|84.453|119.488|||ANOVA|||The reference arm is NRF participants.||119.488|84.453|0.965
72457977|NCT01393964|144438498|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|126.596||||0.164|TWO_SIDED|90.0|95.52|167.783|||ANOVA|||AUC(0-T). The reference arm is NRF participants.||167.783|95.52|0.164
72457978|NCT01393964|144438498|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|116.123||||0.355|TWO_SIDED|90.0|88.458|152.439|||ANOVA|||AUC(0-T). The reference arm is NRF participants.||152.439|88.458|0.355
72457979|NCT01393964|144438498|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|129.858||||0.228|TWO_SIDED|90.0|90.366|186.609|||ANOVA|||AUC (INF). The reference arm is NRF participants.||186.609|90.366|0.228
72457980|NCT01393964|144438498|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|110.4||||0.642|TWO_SIDED|90.0|76.825|158.647|||ANOVA|||AUC(INF). The reference arm is NRF participants.||158.647|76.825|0.642
72500349|NCT03193866|144530967|SUPERIORITY||Mean Difference (Net)|0.1|||||TWO_SIDED|95.0|-0.1|0.3||||||Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||0.3|-0.1|
72500350|NCT03193866|144530967|SUPERIORITY||Mean Difference (Net)|0.1|||||TWO_SIDED|95.0|-0.3|0.4||||||Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||0.4|-0.3|
72500351|NCT03193866|144530967|SUPERIORITY||Mean Difference (Net)|-0.1|||||TWO_SIDED|95.0|-0.2|0.1||||||Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||0.1|-0.2|
72500352|NCT03193866|144530967|SUPERIORITY||Mean Difference (Net)|-0.1|||||TWO_SIDED|95.0|-0.3|0.1||||||Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||0.1|-0.3|
72500353|NCT03193866|144530967|SUPERIORITY||Mean Difference (Net)|0.0|||||TWO_SIDED|95.0|-0.1|0.1||||||Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||0.1|-0.1|
72457981|NCT03879538|144438508|SUPERIORITY||Mean Difference (Net)|-0.57||||0.19|TWO_SIDED|95.0|-1.42|0.28||a priori threshold for statistical significance was p = 0.05.|Mixed Models Analysis||Mean difference is Nitrous Oxide minus Control.|Null hypothesis: Mean of pain score assessed at one-week and one-month follow-up after end of treatment for Nitrous Oxide group equals that assessed at same time points for the Control group.||0.28|-1.42|0.19
72500354|NCT03193866|144530967|SUPERIORITY||Mean Difference (Net)|-0.1|||||TWO_SIDED|95.0|-0.2|0.1||||||Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||0.1|-0.2|
72500355|NCT03193866|144530967|SUPERIORITY||Mean Difference (Net)|0.0|||||TWO_SIDED|95.0|-0.1|0.2||||||Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||0.2|-0.1|
72500356|NCT03193866|144530967|SUPERIORITY||Mean Difference (Net)|0.1|||||TWO_SIDED|95.0|-0.1|0.3||||||Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||0.3|-0.1|
72500357|NCT03193866|144530968|SUPERIORITY||Difference in proportion|4.8|||||TWO_SIDED|95.0|-2.2|11.9||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||11.9|-2.2|
72500358|NCT03193866|144530968|SUPERIORITY||Difference in proportion|9.0|||||TWO_SIDED|95.0|-2.6|20.6||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||20.6|-2.6|
72500359|NCT03193866|144530968|SUPERIORITY||Difference in proportion|-0.7|||||TWO_SIDED|95.0|-7.6|6.2||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||6.2|-7.6|
72457982|NCT03879538|144438509|SUPERIORITY||Mean Difference (Net)|0.13||||0.36|TWO_SIDED|95.0|-0.16|0.43||a priori threshold for statistical significance is p\<0.05.|Mixed Models Analysis||Mean difference is Nitrous oxide minus control.|Null hypothesis for testing difference in means of physical health Z-score between two study groups: mean of physical health Z-score assessed at one-week and one-month follow-ups for Nitrous Oxide group was equal to that assessed at the same follow-up time points for Control group.||0.43|-0.16|0.36
72457983|NCT03879538|144438509|SUPERIORITY||Mean Difference (Net)|0.087||||0.66|TWO_SIDED|95.0|-0.31|0.48||a priori threshold for statistical significance is p\<0.05.|Mixed Models Analysis||Mean difference is Nitrous oxide minus control.|Null hypothesis for testing difference in means of mental health Z-score between two study groups: mean of mental health Z-score assessed at one-week and one-month follow-ups for Nitrous Oxide group was equal to that assessed at the same follow-up time points for Control group.||0.48|-0.31|0.66
72457984|NCT03879538|144438510|SUPERIORITY||Mean Difference (Net)|-0.7||||0.23|TWO_SIDED|95.0|-1.85|0.46||a priori threshold for statistical significance is p = 0.05.|Mixed Models Analysis||Mean difference is Nitrous Oxide minus Control.|Null hypothesis: Mean of PGIC scale assessed at one-week and one-month follow-up time points for Nitrous Oxide patients is equal to that assessed at the same time points for Control patients.||0.46|-1.85|0.23
72457985|NCT00666705|144438524|SUPERIORITY_OR_OTHER||Ratio (percent)|85.76||||||90.0|79.89|92.07|||Mixed Models Analysis|Natural log transformed AUCτ was analyzed using a mixed effect model with treatment as a fixed effect and subject as a random effect.|Ratio (percent) (Test/Reference) of Adjusted Geometric Means|The alternate hypothesis of bioequivalence is that there is no difference between treatment groups. For maraviroc, a sample size of 18 subjects provided 99% power that the 90% confidence interval (CI) for the ratio of Test (raltegravir co-administered with maraviroc) to Reference (maraviroc administered alone) treatment for the area under the plasma concentration-time profile over the dosing interval (AUCτ) would lie within the acceptance region of (80%, 125%).||92.07|79.89|
72457986|NCT00666705|144438525|SUPERIORITY_OR_OTHER||Ratio (percent)|79.48||||||90.0|67.19|94.02|||Mixed Models Analysis|Natural log transformed Cmax was analyzed using a mixed effect model with treatment as a fixed effect and subject as a random effect.|Ratio (percent) (Test/Reference) of Adjusted Geometric Means|The alternate hypothesis of bioequivalence is that there is no difference between treatment groups. For maraviroc, a sample size of 18 subjects provided 91% power that the 90% CI for the ratio of Test (raltegravir co-administered with maraviroc) to Reference (maraviroc administered alone) treatment for the maximum concentration (Cmax) would lie within the acceptance region of (80%, 125%).||94.02|67.19|
72457987|NCT00666705|144438526|SUPERIORITY_OR_OTHER||Ratio (percent)|63.25||||||90.0|44.27|90.39|||Mixed Models Analysis|Natural log transformed AUCτ was analyzed using a mixed effect model with treatment as a fixed effect and subject as a random effect.|Ratio (percent) (Test/Reference) of Adjusted Geometric Means|For raltegravir, a sample size of 18 subjects provided 90% CIs for the difference between treatments of raltegravir (±0.205) on the natural log scale for AUCτ, with 90% coverage probability.||90.39|44.27|
72457988|NCT00666705|144438527|SUPERIORITY_OR_OTHER||Ratio (percent)|90.33||||||90.0|85.28|95.68|||Mixed Models Analysis|Natural log transformed C12 was analyzed using a mixed effect model with treatment as a fixed effect and subject as a random effect.|Ratio (percent) (Test/Reference) of Adjusted Geometric Means|The alternate hypothesis of bioequivalence is that there is no difference between treatment groups.||95.68|85.28|
72457989|NCT00666705|144438528|SUPERIORITY_OR_OTHER||Ratio (percent)|66.77||||||90.0|41.22|108.15|||Mixed Models Analysis|Natural log transformed Cmax was analyzed using a mixed effect model with treatment as a fixed effect and subject as a random effect.|Ratio (percent) (Test/Reference) of Adjusted Geometric Means|For raltegravir, a sample size of 18 subjects provided 90% CIs for the difference between treatments of raltegravir (±0.293) on the natural log scale for Cmax, with 90% coverage probability.||108.15|41.22|
72457990|NCT00666705|144438529|SUPERIORITY_OR_OTHER||ratio (percent)|72.42||||||90.0|57.82|90.71|||Mixed Models Analysis|Natural log transformed C12 was analyzed using a mixed effect model with treatment as a fixed effect and subject as a random effect.|Ratio (percent) (Test/Reference) of Adjusted Geometric Means|||90.71|57.82|
72457991|NCT00687297|144438531|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.5||||1||95.0|||||Fisher Exact|||Fisher's exact test with two-sided Type I error of 5% was used to test the null hypothesis of no difference in response rate between arms.||||1.00
72457992|NCT00687297|144438532|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.49||||0.02|TWO_SIDED|95.0|1.07|2.07||p-value from Wald test|Regression, Cox|The model was adjusted for gender (male vs. female) and stage (Stage IIIB vs. Stage IV/Recurrent)||There was 80% power to detect a 50% improvement in median progression-free survival, using a stratified log-rank test with one-sided Type I error of 10%.||2.07|1.07|0.02
72457993|NCT01228734|144438533|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.629|||<|0.001|TWO_SIDED|95.0|0.498|0.794|||Log Rank|||||0.794|0.498|<0.001
72457994|NCT01109979|144438538|SUPERIORITY_OR_OTHER|||||||0.04||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.04
72457995|NCT02580799|144438540|SUPERIORITY_OR_OTHER||||||=|0.137|TWO_SIDED||||||Chi-squared|||Site A: Site B variability assessment||||=0.137
72457996|NCT02580799|144438540|SUPERIORITY_OR_OTHER||||||=|0.454|TWO_SIDED||||||Chi-squared|||Site A: Site C variability assessment||||=0.454
72457997|NCT02580799|144438540|SUPERIORITY_OR_OTHER||||||=|0.211|TWO_SIDED||||||Chi-squared|||Site A: Site D variability assessment||||=0.211
72457998|NCT02580799|144438540|SUPERIORITY_OR_OTHER||||||=|0.294|TWO_SIDED||||||Chi-squared|||Site A: Site E variability assessment||||=0.294
72457999|NCT02580799|144438542|SUPERIORITY_OR_OTHER||||||=|0.054|TWO_SIDED||||||Chi-squared|||Site B: Site C variability assessment||||=0.054
72458000|NCT02580799|144438542|SUPERIORITY_OR_OTHER||||||=|1|TWO_SIDED||||||Chi-squared|||Site B: Site D variability assessment||||=1.000
72458001|NCT02580799|144438542|SUPERIORITY_OR_OTHER||||||=|0.968|TWO_SIDED||||||Chi-squared|||Site B: Site E variability assessment||||=0.968
72458002|NCT02580799|144438555|SUPERIORITY_OR_OTHER||||||=|0.246|TWO_SIDED||||||Chi-squared|||Site C: Site D variability assessment||||=0.246
72458003|NCT02580799|144438555|SUPERIORITY_OR_OTHER||||||=|0.032|TWO_SIDED||||||Chi-squared|||Site C: Site E variability assessment||||=0.032
72458004|NCT02580799|144438555|SUPERIORITY_OR_OTHER||||||=|0.007|TWO_SIDED||||||Chi-squared|||Site D: Site E variability assessment||||=0.007
72458005|NCT02580799|144438557|SUPERIORITY_OR_OTHER||||||=|0.988|TWO_SIDED||||||Chi-squared|||Abroad: Site A variability assessment||||=0.988
72458006|NCT02580799|144438557|SUPERIORITY_OR_OTHER||||||=|0.008|TWO_SIDED||||||Chi-squared|||Abroad: Site B variability assessment||||=0.008
72458007|NCT02580799|144438557|SUPERIORITY_OR_OTHER||||||=|0.031|TWO_SIDED||||||Chi-squared|||Abroad: Site C variability assessment||||=0.031
72458008|NCT02580799|144438557|SUPERIORITY_OR_OTHER||||||=|0.554|TWO_SIDED||||||Chi-squared|||Abroad: Site D variability assessment||||=0.554
72458009|NCT02580799|144438557|SUPERIORITY_OR_OTHER||||||=|0.709|TWO_SIDED||||||Chi-squared|||Abroad: Site E variability assessment||||=0.709
72500360|NCT03193866|144530968|SUPERIORITY||Difference in proportion|-2.6|||||TWO_SIDED|95.0|-9.4|4.1||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||4.1|-9.4|
72500361|NCT03193866|144530968|SUPERIORITY||Difference in proportion|-2.6|||||TWO_SIDED|95.0|-8.6|3.4||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||3.4|-8.6|
72500362|NCT03193866|144530968|SUPERIORITY||Difference in proportion|3.8|||||TWO_SIDED|95.0|-4.7|12.2||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||12.2|-4.7|
72500363|NCT03193866|144530968|SUPERIORITY||Difference in proportion|0.6|||||TWO_SIDED|95.0|-6.9|8.1||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||8.1|-6.9|
72500364|NCT03193866|144530968|SUPERIORITY||Difference in proportion|3.9|||||TWO_SIDED|95.0|-6.3|14.1||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||14.1|-6.3|
72500365|NCT03193866|144530969|SUPERIORITY||Difference in proportion|-34.1|||||TWO_SIDED|95.0|-40.3|-27.9||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||-27.9|-40.3|
72500366|NCT03193866|144530969|SUPERIORITY||Difference in proportion|-32.2|||||TWO_SIDED|95.0|-43.0|-21.5||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||-21.5|-43.0|
72500367|NCT03193866|144530969|SUPERIORITY||Difference in proportion|-21.8|||||TWO_SIDED|95.0|-27.9|-15.7||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||-15.7|-27.9|
72500368|NCT03193866|144530969|SUPERIORITY||Difference in proportion|-7.8|||||TWO_SIDED|95.0|-14.5|-1.2||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||-1.2|-14.5|
72500369|NCT03193866|144530969|SUPERIORITY||Difference in proportion|-23.6|||||TWO_SIDED|95.0|-28.9|-18.3||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||-18.3|-28.9|
72500370|NCT03193866|144530969|SUPERIORITY||Difference in proportion|-12.7|||||TWO_SIDED|95.0|-18.9|-6.5||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||-6.5|-18.9|
72500371|NCT03193866|144530969|SUPERIORITY||Difference in proportion|-26.5|||||TWO_SIDED|95.0|-32.8|-20.2||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||-20.2|-32.8|
72458010|NCT03456856|144438559|SUPERIORITY||least square mean difference|-4.5|STANDARD_ERROR_OF_MEAN|1.7||0.013|TWO_SIDED|95.0|-8.0|-1.0|||repeated measures linear model|||The estimated mean treatment difference (95% CI) takes into account a presumed -5 bpm change from baseline heart rate in the absence of ivabradine (as seen in the placebo group in the SHIFT study, (NCT02441218, PMID 20801500).||-1.0|-8.0|0.013
72458011|NCT02137785|144438598|SUPERIORITY_OR_OTHER|||||||0.0001|TWO_SIDED|||||Analysis uses observed data only. Missing data was not imputed except for subjects with missing CCR are classified as not having a CCR (ie non-responder).|Cochran-Mantel-Haenszel|CMH test stratified by analysis center||A hierarchical procedure was used to control the level of significance. If the primary analysis was sig (p≤0.05), then AKCR at Week 12 were to be compared. If this analysis was significant, then the AKCR at Week 8 were to be compared. If this analysis was significant, then the CCR at Week 8 was to be compared.||||0.0001
72458012|NCT02137785|144438599|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Mixed Models Analysis|linear mixed model with fixed effects for treatment group, time point, and treatment group by time point interaction||||||<0.0001
72458013|NCT02137785|144438600|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Mixed Models Analysis|linear mixed model with fixed effects for treatment group, time point, and treatment group by time point interaction||||||<0.0001
72458014|NCT02137785|144438601|SUPERIORITY_OR_OTHER|||||||0.0001|TWO_SIDED|||||Analysis uses observed data only. Missing data was not imputed except for subjects with missing CCR are classified as not having a CCR (ie non-responder).|Cochran-Mantel-Haenszel|CMH test stratified by analysis center||||||0.0001
72458015|NCT02206607|144438657|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio MR1/IR|31.27|||||TWO_SIDED|90.0|28.09|34.8||||||||34.80|28.09|
72458016|NCT02206607|144438657|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio MR2/IR|25.56|||||TWO_SIDED|90.0|23.11|28.27||||||||28.27|23.11|
72458017|NCT02206607|144438657|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio MR3/IR|32.04|||||TWO_SIDED|90.0|28.93|35.49||||||||35.49|28.93|
72620842|NCT01887600|144772758|SUPERIORITY||Least squares mean difference|1.64|||<|0.001|TWO_SIDED|95.0|1.37|1.91||LSM Difference p-value is for test of differences.|Mixed Models Analysis|||Hb change from BL to week 56. A Mixed Model of Repeated Measures was applied. The results were based on the estimated difference between the two treatment arms by visit.The model included treatment arm, region, CV history, visits and visit by treatment as categorical variables and baseline Hb and baseline eGFR as continuous variables.||1.91|1.37|<0.001
72620843|NCT01887600|144772758|SUPERIORITY||Least squares mean difference|1.634|||<|0.001|TWO_SIDED|95.0|1.33|1.94||LSM Difference p-value is for test of differences.|Mixed Models Analysis|||Hb change from BL to week 60. A Mixed Model of Repeated Measures was applied. The results were based on the estimated difference between the two treatment arms by visit. The model included treatment arm, region, CV history, visits and visit by treatment as categorical variables and baseline Hb and baseline eGFR as continuous variables.||1.94|1.33|<0.001
72458018|NCT02206607|144438658|SUPERIORITY_OR_OTHER||Least Square Mean|15.72|STANDARD_ERROR_OF_MEAN|3.357||1|TWO_SIDED|80.0|11.39|20.06||1-sided p-value|Mixed Models Analysis|Treatment, period, sequence as fixed effects and subjects-within-sequence as random effects.||||20.06|11.39|1.0000
72458019|NCT02206607|144438658|SUPERIORITY_OR_OTHER||Least Square Mean|16.31|STANDARD_ERROR_OF_MEAN|3.399||1|TWO_SIDED|80.0|11.93|20.7||1-sided p-value|Mixed Models Analysis|Treatment, period, sequence as fixed effects and subjects-within-sequence as random effects.||||20.70|11.93|1.000
72458020|NCT02206607|144438658|SUPERIORITY_OR_OTHER||Least Square Mean|20.38|STANDARD_ERROR_OF_MEAN|3.291||1|TWO_SIDED|80.0|16.13|24.62||1-sided p-value|Mixed Models Analysis|||||24.62|16.13|1.0000
72458021|NCT02206607|144438659|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio MR1/IR|25.21|||||TWO_SIDED|90.0|23.28|27.31||||||||27.31|23.28|
72458022|NCT02206607|144438659|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio MR2/IR|26.38|||||TWO_SIDED|90.0|24.36|28.57||||||||28.57|24.36|
72458023|NCT02206607|144438659|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio MR3/IR|36.94|||||TWO_SIDED|90.0|34.09|40.02||||||||40.02|34.09|
72458024|NCT02206607|144438665|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio MR1/IR|31.06|||||TWO_SIDED|90.0|28.28|34.1||||||||34.10|28.28|
72458025|NCT02206607|144438665|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio MR2/IR|24.96|||||TWO_SIDED|90.0|22.73|27.4||||||||27.40|22.73|
72458026|NCT02206607|144438665|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio MR3/IR|31.69|||||TWO_SIDED|90.0|28.86|34.81||||||||34.81|28.86|
72458027|NCT03979040|144438670|NON_INFERIORITY|A non-inferiority margin of -.5 was set for outcome analysis with a one-sided alpha of .025.|Mean Difference (Net)|-0.5||||0.025|ONE_SIDED|97.5||||P value = .025 (one-sided) and sign test below|Sign test|||||||.025
72458028|NCT03979040|144438671|NON_INFERIORITY|A non-inferiority margin of -.5 was set for outcome analysis with a one-sided alpha of .025.|Mean Difference (Net)|-0.5||||0.025|ONE_SIDED|97.5|||||Sign test|||||||.025
72458029|NCT03979040|144438672|NON_INFERIORITY|A non-inferiority margin of -.5 was set for outcome analysis with a one-sided alpha of .025.|Mean Difference (Net)|-0.5||||0.025|ONE_SIDED|97.5|||||Sign test|||||||.025
72458030|NCT00696241|144438683|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.75|||<|0.001||95.0|-13.17|-8.34||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value presented. Overall 0.05 level of significance for multiple comparisons controlled using stepwise testing procedure.|ANCOVA|||||-8.34|-13.17|<0.001
72458031|NCT00696241|144438683|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.08|||<|0.001|TWO_SIDED|95.0|-14.48|-9.67||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value presented. Overall 0.05 level of significance for multiple comparisons controlled using stepwise testing procedure.|ANCOVA|||||-9.67|-14.48|<0.001
72458032|NCT00696241|144438683|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.21|||<|0.001|TWO_SIDED|95.0|-15.62|-10.81||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value presented. Overall 0.05 level of significance for multiple comparisons controlled using stepwise testing procedure.|ANCOVA|||||-10.81|-15.62|<0.001
72458033|NCT00696241|144438683|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.4||||0.687|TWO_SIDED|95.0|-1.55|2.35||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value presented. Overall 0.05 level of significance for multiple comparisons controlled using stepwise testing procedure.|ANCOVA|||||2.35|-1.55|0.687
72458034|NCT00696241|144438683|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.92||||0.352|TWO_SIDED|95.0|-2.87|1.02||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value presented. Overall 0.05 level of significance for multiple comparisons controlled using stepwise testing procedure.|ANCOVA|||||1.02|-2.87|0.352
72458035|NCT00696241|144438683|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.06||||0.038|TWO_SIDED|95.0|-4.0|-0.12||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value presented. Overall 0.05 level of significance for multiple comparisons controlled using stepwise testing procedure.|ANCOVA|||||-0.12|-4.00|0.038
72458036|NCT00696241|144438684|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.23|||<|0.001|TWO_SIDED|95.0|-15.45|-9.0||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value presented. Overall 0.05 level of significance for multiple comparisons controlled using stepwise testing procedure.|ANCOVA|||||-9.00|-15.45|<0.001
72458037|NCT00696241|144438684|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.42|||<|0.001|TWO_SIDED|95.0|-15.64|-9.2||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value presented. Overall 0.05 level of significance for multiple comparisons controlled using stepwise testing procedure.|ANCOVA|||||-9.20|-15.64|<0.001
72620844|NCT01887600|144772758|SUPERIORITY||Least squares mean difference|1.404|||<|0.001|TWO_SIDED|95.0|1.08|1.73||LSM Difference p-value is for test of differences.|Mixed Models Analysis|||Hb change from BL to week 64. A Mixed Model of Repeated Measures was applied. The results were based on the estimated difference between the two treatment arms by visit. The model included treatment arm, region, CV history, visits and visit by treatment as categorical variables and baseline Hb and baseline eGFR as continuous variables.||1.73|1.08|<0.001
72458038|NCT00696241|144438684|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.53|||<|0.001|TWO_SIDED|95.0|-18.74|-12.31||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value presented. Overall 0.05 level of significance for multiple comparisons controlled using stepwise testing procedure.|ANCOVA|||||-12.31|-18.74|<0.001
72458039|NCT00696241|144438684|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.59||||0.662|TWO_SIDED|95.0|-2.05|3.22||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value presented. Overall 0.05 level of significance for multiple comparisons controlled using stepwise testing procedure.|ANCOVA|||||3.22|-2.05|0.662
72458040|NCT00696241|144438684|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.4||||0.768|TWO_SIDED|95.0|-2.24|3.03||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value presented. Overall 0.05 level of significance for multiple comparisons controlled using stepwise testing procedure.|ANCOVA|||||3.03|-2.24|0.768
72458041|NCT00696241|144438684|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.71||||0.043|TWO_SIDED|95.0|-5.34|-0.09||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value presented. Overall 0.05 level of significance for multiple comparisons controlled using stepwise testing procedure.|ANCOVA|||||-0.09|-5.34|0.043
72458042|NCT00696241|144438685|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.78|||<|0.001|TWO_SIDED|95.0|-8.34|-5.22||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-5.22|-8.34|<0.001
72458043|NCT00696241|144438685|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.68|||<|0.001|TWO_SIDED|95.0|-9.24|-6.13||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-6.13|-9.24|<0.001
72458044|NCT00696241|144438685|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.92|||<|0.001|TWO_SIDED|95.0|-9.47|-6.36||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-6.36|-9.47|<0.001
72458045|NCT00696241|144438685|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.27||||0.679|TWO_SIDED|95.0|-0.99|1.52||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||1.52|-0.99|0.679
72458046|NCT00696241|144438685|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.64||||0.319|TWO_SIDED|95.0|-1.89|0.62||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||0.62|-1.89|0.319
72458047|NCT00696241|144438685|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.87||||0.172|TWO_SIDED|95.0|-2.13|0.38||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||0.38|-2.13|0.172
72458048|NCT00696241|144438686|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.02|||<|0.001|TWO_SIDED|95.0|-8.83|-5.22||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-5.22|-8.83|<0.001
72458049|NCT00696241|144438686|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.07|||<|0.001|TWO_SIDED|95.0|-8.87|-5.27||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-5.27|-8.87|<0.001
72458050|NCT00696241|144438686|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.62|||<|0.001|TWO_SIDED|95.0|-10.42|-6.82||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-6.82|-10.42|<0.001
72458051|NCT00696241|144438686|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.09||||0.908|TWO_SIDED|95.0|-1.39|1.56||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||1.56|-1.39|0.908
72458052|NCT00696241|144438686|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.04||||0.956|TWO_SIDED|95.0|-1.43|1.52||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||1.52|-1.43|0.956
72458053|NCT00696241|144438686|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.51||||0.044|TWO_SIDED|95.0|-2.98|-0.04||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-0.04|-2.98|0.044
72458054|NCT00696241|144438687|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.03|||<|0.001|TWO_SIDED|95.0|-13.59|-8.48||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-8.48|-13.59|<0.001
72458055|NCT00696241|144438687|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.2|||<|0.001|TWO_SIDED|95.0|-14.75|-9.65||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-9.65|-14.75|<0.001
72500372|NCT03193866|144530969|SUPERIORITY||Difference in proportion|-31.7|||||TWO_SIDED|95.0|-40.1|-23.2||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||-23.2|-40.1|
72500373|NCT03193866|144530970|SUPERIORITY||Difference in proportion|-33.2|||||TWO_SIDED|95.0|-39.4|-27.0||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||-27.0|-39.4|
72500374|NCT03193866|144530970|SUPERIORITY||Difference in proportion|-30.6|||||TWO_SIDED|95.0|-41.4|-19.8||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||-19.8|-41.4|
72500375|NCT03193866|144530970|SUPERIORITY||Difference in proportion|-20.8|||||TWO_SIDED|95.0|-27.0|-14.7||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||-14.7|-27.0|
72500376|NCT03193866|144530970|SUPERIORITY||Difference in proportion|-7.0|||||TWO_SIDED|95.0|-13.6|-0.3||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||-0.3|-13.6|
72500377|NCT03193866|144530970|SUPERIORITY||Difference in proportion|-23.7|||||TWO_SIDED|95.0|-29.2|-18.3||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||-18.3|-29.2|
72500378|NCT03193866|144530970|SUPERIORITY||Difference in proportion|-12.3|||||TWO_SIDED|95.0|-18.6|-6.1||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||-6.1|-18.6|
72500379|NCT03193866|144530970|SUPERIORITY||Difference in proportion|-25.3|||||TWO_SIDED|95.0|-31.7|-19.0||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||-19.0|-31.7|
72500380|NCT03193866|144530970|SUPERIORITY||Difference in proportion|-29.5|||||TWO_SIDED|95.0|-38.2|-20.8||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||-20.8|-38.2|
72620845|NCT01887600|144772758|SUPERIORITY||Least squares mean difference|1.499|||<|0.001|TWO_SIDED|95.0|1.18|1.82||LSM Difference p-value is for test of differences.|Mixed Models Analysis|||Hb change From BL to week 68. A Mixed Model of Repeated Measures was applied. The results were based on the estimated difference between the two treatment arms by visit. The model included treatment arm, region, CV history, visits and visit by treatment as categorical variables and baseline Hb and baseline eGFR as continuous variables.||1.82|1.18|<0.001
72458056|NCT00696241|144438687|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.41|||<|0.001|TWO_SIDED|95.0|-15.97|-10.86||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-10.86|-15.97|<0.001
72458057|NCT00696241|144438687|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.16||||0.879|TWO_SIDED|95.0|-1.9|2.22||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||2.22|-1.90|0.879
72458058|NCT00696241|144438687|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.01||||0.334|TWO_SIDED|95.0|-3.07|1.04||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||1.04|-3.07|0.334
72458059|NCT00696241|144438687|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.22||||0.034|TWO_SIDED|95.0|-4.28|-0.16||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-0.16|-4.28|0.034
72458060|NCT00696241|144438688|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.12|||<|0.001|TWO_SIDED|95.0|-8.79|-5.45||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-5.45|-8.79|<0.001
72458061|NCT00696241|144438688|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.84|||<|0.001|TWO_SIDED|95.0|-9.51|-6.18||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-6.18|-9.51|<0.001
72458062|NCT00696241|144438688|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.28|||<|0.001|TWO_SIDED|95.0|-9.94|-6.61||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-6.61|-9.94|<0.001
72458063|NCT00696241|144438688|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.11||||0.877|TWO_SIDED|95.0|-1.24|1.45||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||1.45|-1.24|0.877
72458064|NCT00696241|144438688|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.62||||0.369|TWO_SIDED|95.0|-1.96|0.73||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||0.73|-1.96|0.369
72458065|NCT00696241|144438688|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.05||||0.126|TWO_SIDED|95.0|-2.39|0.3||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||0.30|-2.39|0.126
72458066|NCT00696241|144438689|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.13|||<|0.001|TWO_SIDED|95.0|-12.79|-7.48||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-7.48|-12.79|<0.001
72458067|NCT00696241|144438689|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.43|||<|0.001|TWO_SIDED|95.0|-14.07|-8.78||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-8.78|-14.07|<0.001
72458068|NCT00696241|144438689|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.38|||<|0.001|TWO_SIDED|95.0|-15.03|-9.73||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-9.73|-15.03|<0.001
72458069|NCT00696241|144438689|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.03||||0.346|TWO_SIDED|95.0|-1.12|3.18||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||3.18|-1.12|0.346
72458070|NCT00696241|144438689|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.26||||0.811|TWO_SIDED|95.0|-2.4|1.88||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||1.88|-2.40|0.811
72458071|NCT00696241|144438689|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.21||||0.267|TWO_SIDED|95.0|-3.35|0.93||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||0.93|-3.35|0.267
72458072|NCT00696241|144438690|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.03|||<|0.001|TWO_SIDED|95.0|-7.84|-4.21||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-4.21|-7.84|<0.001
72458073|NCT00696241|144438690|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.94|||<|0.001|TWO_SIDED|95.0|-8.75|-5.13||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-5.13|-8.75|<0.001
72458074|NCT00696241|144438690|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.84|||<|0.001|TWO_SIDED|95.0|-8.65|-5.03||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-5.03|-8.65|<0.001
72458075|NCT00696241|144438690|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.64||||0.394|TWO_SIDED|95.0|-0.83|2.1||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||2.10|-0.83|0.394
72458076|NCT00696241|144438690|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.27||||0.712|TWO_SIDED|95.0|-1.74|1.19||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||1.19|-1.74|0.712
72458077|NCT00696241|144438690|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.17||||0.818|TWO_SIDED|95.0|-1.63|1.29||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||1.29|-1.63|0.818
72458078|NCT00696241|144438691|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.35|||<|0.001|TWO_SIDED|95.0|-14.05|-8.64||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-8.64|-14.05|<0.001
72458079|NCT00696241|144438691|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.68|||<|0.001|TWO_SIDED|95.0|-15.38|-9.98||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-9.98|-15.38|<0.001
72458080|NCT00696241|144438691|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.81|||<|0.001|TWO_SIDED|95.0|-16.51|-11.11||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-11.11|-16.51|<0.001
72458081|NCT00696241|144438691|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.35||||0.75|TWO_SIDED|95.0|-1.83|2.54||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||2.54|-1.83|0.750
72458082|NCT00696241|144438691|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.98||||0.378|TWO_SIDED|95.0|-3.16|1.2||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||1.20|-3.16|0.378
72620846|NCT01887600|144772758|SUPERIORITY||Least squares mean difference|1.438|||<|0.001|TWO_SIDED|95.0|1.1|1.78||LSM Difference p-value is for test of differences.|Mixed Models Analysis|||Hb change from BL to week 72. A Mixed Model of Repeated Measures was applied. The results were based on the estimated difference between the two treatment arms by visit. The model included treatment arm, region, CV history, visits and visit by treatment as categorical variables and baseline Hb and baseline eGFR as continuous variables.||1.78|1.10|<0.001
72458083|NCT00696241|144438691|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.1||||0.059|TWO_SIDED|95.0|-4.28|0.08||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||0.08|-4.28|0.059
72458084|NCT00696241|144438692|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.25|||<|0.001|TWO_SIDED|95.0|-9.02|-5.48||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-5.48|-9.02|<0.001
72458085|NCT00696241|144438692|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.16|||<|0.001|TWO_SIDED|95.0|-9.92|-6.4||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-6.40|-9.92|<0.001
72458086|NCT00696241|144438692|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.41|||<|0.001|TWO_SIDED|95.0|-10.17|-6.65||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-6.65|-10.17|<0.001
72458087|NCT00696241|144438692|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.14||||0.845|TWO_SIDED|95.0|-1.29|1.57||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||1.57|-1.29|0.845
72458088|NCT00696241|144438692|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.77||||0.29|TWO_SIDED|95.0|-2.19|0.65||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||0.65|-2.19|0.290
72458089|NCT00696241|144438692|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.02||||0.161|TWO_SIDED|95.0|-2.44|0.41||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||0.41|-2.44|0.161
72458090|NCT00696241|144438693|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.94|||<|0.001|TWO_SIDED|95.0|-13.88|-8.0||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-8.00|-13.88|<0.001
72458091|NCT00696241|144438693|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.18|||<|0.001|TWO_SIDED|95.0|-14.11|-8.24||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-8.24|-14.11|<0.001
72458092|NCT00696241|144438693|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.21|||<|0.001|TWO_SIDED|95.0|-15.15|-9.28||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-9.28|-15.15|<0.001
72458093|NCT00696241|144438693|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.05||||0.385|TWO_SIDED|95.0|-3.43|1.33||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||1.33|-3.43|0.385
72458094|NCT00696241|144438693|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.29||||0.285|TWO_SIDED|95.0|-3.66|1.08||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||1.08|-3.66|0.285
72458095|NCT00696241|144438693|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.33||||0.054|TWO_SIDED|95.0|-4.7|0.04||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||0.04|-4.70|0.054
72458096|NCT00696241|144438694|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.84|||<|0.001|TWO_SIDED|95.0|-8.93|-4.75||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-4.75|-8.93|<0.001
72458097|NCT00696241|144438694|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.8|||<|0.001|TWO_SIDED|95.0|-8.89|-4.72||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-4.72|-8.89|<0.001
72458098|NCT00696241|144438694|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.55|||<|0.001|TWO_SIDED|95.0|-9.64|-5.47||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-5.47|-9.64|<0.001
72458099|NCT00696241|144438694|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4||||0.642|TWO_SIDED|95.0|-2.09|1.29||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||1.29|-2.09|0.642
72458100|NCT00696241|144438694|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.36||||0.672|TWO_SIDED|95.0|-2.05|1.32||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||1.32|-2.05|0.672
72458101|NCT00696241|144438694|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.11||||0.196|TWO_SIDED|95.0|-2.8|0.57||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||0.57|-2.80|0.196
72458102|NCT00696241|144438695|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.48|||<|0.001|TWO_SIDED|95.0|2.71|7.39||P-value for response criteria for systolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value is presented.|Regression, Logistic|||||7.39|2.71|<0.001
72458103|NCT00696241|144438695|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.97|||<|0.001|TWO_SIDED|95.0|3.01|8.2||P-value for response criteria for systolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value is presented.|Regression, Logistic|||||8.20|3.01|<0.001
72458104|NCT00696241|144438695|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.53|||<|0.001|TWO_SIDED|95.0|3.95|10.79||P-value for response criteria for systolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value is presented.|Regression, Logistic|||||10.79|3.95|<0.001
72458105|NCT00696241|144438695|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.79||||0.173|TWO_SIDED|95.0|0.57|1.11||P-value for response criteria for systolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value is presented.|Regression, Logistic|||||1.11|0.57|0.173
72458106|NCT00696241|144438695|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.88||||0.449|TWO_SIDED|95.0|0.63|1.23||P-value for response criteria for systolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value is presented.|Regression, Logistic|||||1.23|0.63|0.449
72458107|NCT00696241|144438695|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.15||||0.402|TWO_SIDED|95.0|0.83|1.62||P-value for response criteria for systolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value is presented.|Regression, Logistic|||||1.62|0.83|0.402
72458108|NCT00696241|144438696|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.86|||<|0.001|TWO_SIDED|95.0|1.82|4.48||P-value for response criteria for diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic diastolic blood pressure as a covariate. The unadjusted p-value is presented.|Regression, Logistic|||||4.48|1.82|<0.001
72458109|NCT00696241|144438696|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.39|||<|0.001|TWO_SIDED|95.0|2.15|5.35||P-value for response criteria for diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic diastolic blood pressure as a covariate. The unadjusted p-value is presented.|Regression, Logistic|||||5.35|2.15|<0.001
72458110|NCT00696241|144438696|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.81|||<|0.001|TWO_SIDED|95.0|2.41|6.02||P-value for response criteria for diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic diastolic blood pressure as a covariate. The unadjusted p-value is presented.|Regression, Logistic|||||6.02|2.41|<0.001
72458111|NCT00696241|144438696|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.76||||0.177|TWO_SIDED|95.0|0.52|1.13||P-value for response criteria for diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic diastolic blood pressure as a covariate. The unadjusted p-value is presented.|Regression, Logistic|||||1.13|0.52|0.177
72458112|NCT00696241|144438696|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.91||||0.628|TWO_SIDED|95.0|0.61|1.35||P-value for response criteria for diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic diastolic blood pressure as a covariate. The unadjusted p-value is presented.|Regression, Logistic|||||1.35|0.61|0.628
72500381|NCT03193866|144530971|SUPERIORITY||Mean Difference (Final Values)|-0.03|||||TWO_SIDED|95.0|-0.07|0.0||||||Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||0.00|-0.07|
72500382|NCT03193866|144530971|SUPERIORITY||Mean Difference (Final Values)|-0.02|||||TWO_SIDED|95.0|-0.09|0.06||||||Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||0.06|-0.09|
72500383|NCT03193866|144530971|SUPERIORITY||Mean Difference (Final Values)|0.0|||||TWO_SIDED|95.0|-0.03|0.03||||||Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||0.03|-0.03|
72370490|NCT00488683|144251632|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.51||||0.04||95.0|||||Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccination and hSBA titers one month after booster vaccination for the serogroup W-135||||0.04
72458113|NCT00696241|144438696|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.02||||0.928|TWO_SIDED|95.0|0.68|1.52||P-value for response criteria for diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic diastolic blood pressure as a covariate. The unadjusted p-value is presented.|Regression, Logistic|||||1.52|0.68|0.928
72458114|NCT00696241|144438697|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.53|||<|0.001|TWO_SIDED|95.0|2.66|7.72||P-value for joint response criteria for systolic blood pressure and diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value is presented.|Regression, Logistic|||||7.72|2.66|<0.001
72458115|NCT00696241|144438697|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.04|||<|0.001|TWO_SIDED|95.0|2.96|8.58||P-value for joint response criteria for systolic blood pressure and diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value is presented.|Regression, Logistic|||||8.58|2.96|<0.001
72458116|NCT00696241|144438697|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.75|||<|0.001|TWO_SIDED|95.0|3.96|11.48||P-value for joint response criteria for systolic blood pressure and diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value is presented.|Regression, Logistic|||||11.48|3.96|<0.001
72620847|NCT01887600|144772758|SUPERIORITY||Least squares mean difference|1.185|||<|0.001|TWO_SIDED|95.0|0.83|1.54||LSM Difference p-value is for test of differences.|Mixed Models Analysis|||Hb change from BL to week 76. A Mixed Model of Repeated Measures was applied. The results were based on the estimated difference between the two treatment arms by visit. The model included treatment arm, region, CV history, visits and visit by treatment as categorical variables and baseline Hb and baseline eGFR as continuous variables.||1.54|0.83|<0.001
72458117|NCT00696241|144438697|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.81||||0.217|TWO_SIDED|95.0|0.58|1.13||P-value for joint response criteria for systolic blood pressure and diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value is presented.|Regression, Logistic|||||1.13|0.58|0.217
72500384|NCT03193866|144530971|SUPERIORITY||Mean Difference (Final Values)|0.01|||||TWO_SIDED|95.0|-0.03|0.05||||||Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||0.05|-0.03|
72500385|NCT03193866|144530971|SUPERIORITY||Mean Difference (Final Values)|0.01|||||TWO_SIDED|95.0|-0.02|0.04||||||Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||0.04|-0.02|
72392474|NCT01233258|144292286|SUPERIORITY_OR_OTHER|||||||0.0001|||||||ANOVA|No adjustment, no transformation of data seemed to be necessary.||Null hypothesis: bleeding rates are equal, alternative hypothesis rates are unequal. Power calculation not done for this comparison as not primary comparison.||||0.0001
72392475|NCT01233258|144292287|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin 10%|Median Difference (Net)|-0.0001||||0.0001|ONE_SIDED|95.0|-0.049|||No multiplicity adjustment as not primary endpoint.|Exact Permutation Test for paired sample||Confidence interval calculated with exact Hodges- Lehmann estimates for CS/EP minus CS/ADJ|Null hypothesis: the proportion of bleeds controlled by no more than 2 infusions in the CS/EP group plus 10% is less than the proportion of bleeds controlled by no more than 2 infusions in the CS/ADJ group. Alternative hypothesis: the proportion of bleeds controlled by no more than 2 infusions in the CS/EP group plus 10% is greater than or equal to the proportion of bleeds controlled by no more than 2 infusions in the CS/ADJ group. No power calculation since this is not the primary comparison.|||-0.0490|0.0001
72392476|NCT01146418|144292318|SUPERIORITY_OR_OTHER_LEGACY||Estimated Difference|-1.8|||||TWO_SIDED|95.0|-6.5|3.0|||Clopper-Pearson method|Difference calculated using generalized linear model including covariates for treatment group and age class as stratified (≤38 yrs vs \>38 yrs)||||3.0|-6.5|
72392477|NCT01146418|144292319|SUPERIORITY_OR_OTHER_LEGACY||Estimated difference|-1.2|||||TWO_SIDED|95.0|-5.7|3.4|||Clopper-Pearson method|Difference calculated using generalized linear model including covariates for treatment group and age class as stratified (≤38 yrs vs \>38 yrs)||||3.4|-5.7|
72392478|NCT00279305|144292339|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.139|STANDARD_ERROR_OF_MEAN|0.104||0.05|TWO_SIDED|95.0|-0.0699|0.348|||ANCOVA|||"The calculation for the concentration of c-peptide is a weighted average of the 6 timed measurements of c-peptide in nano-moles/Liter. We try to distinguish this calculation from the AUC by referring to it as the AUC mean and may be expressed algebraically as the AUC/(120 min.); thus, the units are the same as the y-axis."||0.348|-0.0699|0.05
72392479|NCT04617509|144292381|SUPERIORITY|Relative bioavailability for Formulation A (FASTED) versus Formulation B (FASTED). The calculated relative bioavailability is based on Cmax ratio (ratio of geometric means) and is presented with 90% CI.|Ratio of geometric means|1.4514|||||TWO_SIDED|90.0|1.111|1.4514||||||Relative bioavailability (A versus B)||1.4514|1.1110|
72392480|NCT04617509|144292381|SUPERIORITY|Relative bioavailability for Formulation A (FED) versus Formulation A (FASTED). The calculated relative bioavailability is based on Cmax ratio (ratio of geometric means) and is presented with 90% CI.|Ratio of geometric mean|0.5497|||||TWO_SIDED|90.0|0.3977|0.7597||||||Relative bioavailability (A FED versus A FASTED)||0.7597|0.3977|
72392481|NCT04617509|144292382|SUPERIORITY|Relative bioavailability for Formulation A (FASTED) versus Formulation B (FASTED). The calculated relative bioavailability is based on AUC0-inf ratio (ratio of geometric means) and is presented with 90% CI.|Ratio of geometric mean|1.3441|||||TWO_SIDED|90.0|1.0953|1.6495||||||Relative bioavailability (A versus B)||1.6495|1.0953|
72392482|NCT04617509|144292382|SUPERIORITY|Relative bioavailability for Formulation A (FED) versus Formulation A (FASTED). The calculated relative bioavailability is based on AUC0-inf ratio (ratio of geometric means) and is presented with 90% CI.|Ratio of geometric mean|0.7327|||||TWO_SIDED|90.0|0.591|0.9083||||||Relative bioavailability (A FED versus A FASTED)||0.9083|0.5910|
72392483|NCT04617509|144292383|SUPERIORITY|Relative bioavailability for Formulation A (FASTED) versus Formulation B (FASTED). The calculated relative bioavailability is based on AUC0-24h ratio (ratio of geometric means) and is presented with 90% CI.|Ratio of geometric mean|1.371|||||TWO_SIDED|90.0|1.112|1.6904||||||Relative bioavailability (A versus B)||1.6904|1.1120|
72392484|NCT04617509|144292383|SUPERIORITY|Relative bioavailability for Formulation A (FED) versus Formulation A (FASTED). The calculated relative bioavailability is based on AUC0-24h ratio (ratio of geometric means) and is presented with 90% CI.|Ratio of geometric mean|0.7083|||||TWO_SIDED|90.0|0.5728|0.8759||||||Relative bioavailability (A FED versus A FASTED)||0.8759|0.5728|
72392485|NCT00790023|144292393|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.94|||<|0.0001|TWO_SIDED|95.0|0.57|1.32||The p-value from primary outcome was adjusted at alpha=0.025.|ANCOVA|||The null hypothesis is that there is no difference in primary outcome when compare active to placebo group. The alternative hypothesis is that there is a difference in primary outcome when compare active to placebo group. It was estimated that 200 subjects per group will provide at least 85% power to detect a difference between treatment groups of 0.7 in the change from baseline in rTNSS with a two-sided alpha level of 0.025.||1.32|0.57|<0.0001
72458118|NCT00696241|144438697|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.9||||0.537|TWO_SIDED|95.0|0.64|1.26||P-value for joint response criteria for systolic blood pressure and diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value is presented.|Regression, Logistic|||||1.26|0.64|0.537
72563030|NCT00292227|144658108|SUPERIORITY_OR_OTHER||Mean Difference (Net)|11.02||||||95.0|9.12|12.93|||ANOVA|The ANOVA model included the factors treatment, period, sequence, and subject(sequence).|The direction of the estimate is Moxifloxacin - Placebo. Mean difference was estimated from the ANOVA model.|For the analysis of the assay sensitivity, an ANOVA with the factors treatment, period, sequence, and subject(sequence) for comparison of moxifloxacin vs placebo (cross-over comparison) was performed. The point estimates for the difference between placebo and positive control (moxifloxacin) and the respective 95% confidence intervals were calculated.||12.93|9.12|
72563031|NCT00292227|144658109|SUPERIORITY_OR_OTHER||Mean Difference (Net)|11.3||||||95.0|9.94|12.67|||ANOVA|The ANOVA model included the factors treatment, period, sequence, and subject(sequence).|The direction of the estimate is Moxifloxacin - Placebo. Mean difference was estimated from the ANOVA model.|For the analysis of the assay sensitivity, an ANOVA with the factors treatment, period, sequence, and subject(sequence) for comparison of moxifloxacin vs placebo (cross-over comparison) was performed. The point estimates for the difference between placebo and positive control (moxifloxacin) and the respective 95% confidence intervals were calculated.||12.67|9.94|
72458119|NCT00696241|144438697|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.2||||0.276|TWO_SIDED|95.0|0.86|1.68||P-value for joint response criteria for systolic blood pressure and diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value is presented.|Regression, Logistic|||||1.68|0.86|0.276
72563032|NCT00292227|144658110|SUPERIORITY_OR_OTHER||Mean Difference (Net)|8.28||||||95.0|6.85|9.7|||ANOVA|The ANOVA model included the factors treatment, period, sequence, and subject(sequence).|The direction of the estimate is Moxifloxacin - Placebo. Mean difference was estimated from the ANOVA model.|For the analysis of the assay sensitivity, an ANOVA with the factors treatment, period, sequence, and subject(sequence) for comparison of moxifloxacin vs placebo (cross-over comparison) was performed. The point estimates for the difference between placebo and positive control (moxifloxacin) and the respective 95% confidence intervals were calculated.||9.70|6.85|
72620848|NCT01887600|144772758|SUPERIORITY||Least squares mean difference|1.443|||<|0.001|TWO_SIDED|95.0|1.11|1.78||LSM Difference p-value is for test of differences.|Mixed Models Analysis|||Hb change from BL to week 80. A Mixed Model of Repeated Measures was applied. The results were based on the estimated difference between the two treatment arms by visit. The model included treatment arm, region, CV history, visits and visit by treatment as categorical variables and baseline Hb and baseline eGFR as continuous variables.||1.78|1.11|<0.001
72620849|NCT01887600|144772758|SUPERIORITY||Least squares mean difference|1.374|||<|0.001|TWO_SIDED|95.0|0.99|1.75||LSM Difference p-value is for test of differences.|Mixed Models Analysis|||Hb change from BL to week 84. A Mixed Model of Repeated Measures was applied. The results were based on the estimated difference between the two treatment arms by visit. The model included treatment arm, region, CV history, visits and visit by treatment as categorical variables and baseline Hb and baseline eGFR as continuous variables.||1.75|0.99|<0.001
72392486|NCT00790023|144292393|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.08|||<|0.0001|TWO_SIDED|95.0|0.7|1.45||The p-value from primary outcome was adjusted at alpha=0.025.|ANCOVA|||The null hypothesis is that there is no difference in primary outcome when compare active to placebo group. The alternative hypothesis is that there is a difference in primary outcome when compare active to placebo group. It was estimated that 200 subjects per group will provide at least 85% power to detect a difference between treatment groups of 0.7 in the change from baseline in rTNSS with a two-sided alpha level of 0.025.||1.45|0.70|<0.0001
72458120|NCT01742832|144438698|OTHER|Linear repeated measures regression models were constructed to assess trends over time between groups where the dependent variable was outcome measure (MADRS score) and independent variables included visit, treatment group, visit by treatment group interaction, and any baseline variables that were significant between groups.||||||0.342||||||P-value for linear regression assessing outcome measure (MADRS score) and treatment group.|Regression, Linear|||||||0.342
72458121|NCT03060525|144438728|SUPERIORITY||Mean Difference (Final Values)|-3.36|STANDARD_ERROR_OF_MEAN|1.51||0.026|TWO_SIDED|95.0|-6.32|-0.41|||Mixed Models Analysis|||Difference in weight change from Baseline to 6months, between Immediate Intervention participants (group and videophone combined) vs. Delayed Intervention participants (group and videophone combined). \[analysis of 2 arms, immediate intervention vs. delayed intervention\]||-0.41|-6.32|0.026
72458122|NCT03060525|144438729|SUPERIORITY||Mean Difference (Final Values)|-1.27|STANDARD_ERROR_OF_MEAN|0.59||0.03|TWO_SIDED|95.0|-2.42|-0.12|||Mixed Models Analysis|||Difference in Body Mass Index (BMI) change from Baseline to 6months, between Immediate Intervention participants (group and videophone combined) vs. Delayed Intervention participants (group and videophone combined). \[analysis of 2 arms, immediate intervention vs. delayed intervention\]||-0.12|-2.42|0.03
72458123|NCT03060525|144438730|SUPERIORITY||Median Difference (Net)|247.5||||0.63|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||change in amount of physical activity = 6-month MET-minutes/week - baseline MET-minutes/week (change from pre to post intervention), using the International Physical Activity Questionnaire. IPAQ score is a continuous measure and reports median MET-minutes per week (a combination of walking met-minutes/week + moderate activity MET-minutes/week + vigorous activity MET-minutes/week). \[analysis of 2 arms, immediate intervention vs. delayed intervention\]||||0.63
72458124|NCT00090519|144438731|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01||||0.969|TWO_SIDED|95.0|-0.714|0.686|||ANOVA|||||0.686|-0.714|0.969
72458125|NCT00090519|144438732|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.09||||0.015|TWO_SIDED|95.0|0.21|1.97||P-value is for change from baseline.|ANCOVA|||||1.97|0.21|0.015
72458126|NCT00090519|144438733|SUPERIORITY_OR_OTHER|||||||0.577||95.0||||P-value is for first occurrence of focal/grid photocoagulation yes versus no.|Chi-squared|||||||0.577
72458127|NCT00090519|144438734|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.45||||0.041|TWO_SIDED|95.0|0.02|0.87||P-value is for change from baseline.|ANCOVA|||||0.87|0.02|0.041
72458128|NCT00090519|144438735|SUPERIORITY_OR_OTHER|||||||0.475||95.0||||P-value is for progression of nonproliferative diabetic retinopathy (DR) by seven-field stereo fundus photography progression versus no progression.|Chi-squared|||||||0.475
72458129|NCT00090519|144438736|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.52||||0.211|TWO_SIDED|95.0|-0.87|3.92||P-value is for change from baseline.|ANCOVA|||||3.92|-0.87|0.211
72458130|NCT00090519|144438737|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|63.22||||0.365|TWO_SIDED|95.0|-73.68|200.12||P-value is for change from baseline.|t-test, 2 sided|||||200.12|-73.68|0.365
72458131|NCT00090519|144438738|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.52||||0.009|TWO_SIDED|95.0|0.38|2.66||P-value is for change from baseline.|ANCOVA|||||2.66|0.38|0.009
72458132|NCT00090519|144438740|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.47||||0.081|TWO_SIDED|95.0|0.2|1.12||P-value is for occurrence of sustained moderate visual loss (SMVL) in a diabetic retinopathy (DR) study eye yes versus no.|Chi-squared|||||1.12|0.20|0.081
72500386|NCT03193866|144530971|SUPERIORITY||Mean Difference (Final Values)|0.03|||||TWO_SIDED|95.0|-0.01|0.06||||||Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||0.06|-0.01|
72500387|NCT03193866|144530971|SUPERIORITY||Mean Difference (Final Values)|0.03|||||TWO_SIDED|95.0|0.0|0.06||||||Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||0.06|0.00|
72500388|NCT03193866|144530971|SUPERIORITY||Mean Difference (Final Values)|-0.02|||||TWO_SIDED|95.0|-0.06|0.03||||||Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||0.03|-0.06|
72500389|NCT03193866|144530972|SUPERIORITY||Mean Difference (Final Values)|0.9|||||TWO_SIDED|95.0|-3.3|5.2||||||Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||5.2|-3.3|
72620850|NCT01887600|144772758|SUPERIORITY||Least squares mean difference|1.171|||<|0.001|TWO_SIDED|95.0|0.79|1.55||LSM Difference p-value is for test of differences.|Mixed Models Analysis|||Hb change from BL to week 88. A Mixed Model of Repeated Measures was applied. The results were based on the estimated difference between the two treatment arms by visit. The model included treatment arm, region, CV history, visits and visit by treatment as categorical variables and baseline Hb and baseline eGFR as continuous variables.||1.55|0.79|<0.001
72500390|NCT03193866|144530972|SUPERIORITY||Mean Difference (Final Values)|-1.5|||||TWO_SIDED|95.0|-9.4|6.4||||||Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||6.4|-9.4|
72500391|NCT03193866|144530972|SUPERIORITY||Mean Difference (Final Values)|-1.4|||||TWO_SIDED|95.0|-4.2|1.4||||||Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||1.4|-4.2|
72620851|NCT01887600|144772758|SUPERIORITY||Least squares mean difference|1.382|||<|0.001|TWO_SIDED|95.0|0.98|1.78||LSM Difference p-value is for test of differences.|Mixed Models Analysis|||Hb change from BL to week 92. A Mixed Model of Repeated Measures was applied. The results were based on the estimated difference between the two treatment arms by visit. The model included treatment arm, region, CV history, visits and visit by treatment as categorical variables and baseline Hb and baseline eGFR as continuous variables.||1.78|0.98|<0.001
72458133|NCT04919499|144438787|OTHER|A mixed model with repeated measurements (MMRM) was used for the analysis with fixed, categorical effects of treatment at each visit and the fixed continuous effects of baseline at each visit. Visit was treated as the repeated measure with an unstructured covariance structure used to model the within-patient measurements. The Kenward-Roger approximation was used to estimate denominator degrees of freedom and adjust standard errors.|Adjusted mean difference|-0.0252|STANDARD_ERROR_OF_MEAN|0.0376|||TWO_SIDED|95.0|-0.1048|0.0545|||||Calculated as \[high-dose BI 765128\] - \[Sham\]|||0.0545|-0.1048|
72458134|NCT04919499|144438788|OTHER|A mixed model with repeated measurements (MMRM) was used for the analysis with fixed, categorical effects of treatment at each visit and the fixed continuous effects of baseline at each visit. Visit was treated as the repeated measure with an unstructured covariance structure used to model the within-patient measurements. The Kenward-Roger approximation was used to estimate denominator degrees of freedom and adjust standard errors.|Adjusted mean difference|-0.0101|STANDARD_ERROR_OF_MEAN|0.0236|||TWO_SIDED|95.0|-0.0625|0.0422|||||Calculated as \[high-dose BI 765128\] - \[Sham\]|||0.0422|-0.0625|
72500392|NCT03193866|144530972|SUPERIORITY||Mean Difference (Final Values)|-2.6|||||TWO_SIDED|95.0|-5.9|0.8||||||Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||0.8|-5.9|
72458135|NCT04919499|144438789|OTHER|A mixed model with repeated measurements (MMRM) was used for the analysis with fixed, categorical effects of treatment at each visit and the fixed continuous effects of baseline at each visit. Visit was treated as the repeated measure with an unstructured covariance structure used to model the within-patient measurements. The Kenward-Roger approximation was used to estimate denominator degrees of freedom and adjust standard errors.|Adjusted mean difference|0.0016|STANDARD_ERROR_OF_MEAN|0.0181|||TWO_SIDED|95.0|-0.0504|0.0536|||||Calculated as \[high-dose BI 765128\] - \[Sham\]|||0.0536|-0.0504|
72458136|NCT04919499|144438790|OTHER|A mixed model with repeated measurements (MMRM) was used for the analysis with fixed, categorical effects of treatment at each visit and the fixed continuous effects of baseline at each visit. Visit was treated as the repeated measure with an unstructured covariance structure used to model the within-patient measurements. The Kenward-Roger approximation was used to estimate denominator degrees of freedom and adjust standard errors.|Adjusted mean difference|0.1|STANDARD_ERROR_OF_MEAN|2.4|||TWO_SIDED|95.0|-4.7|5.0|||||"Calculated as \[high-dose BI 765128\] - \[Sham\]~Results were rounded to one decimal place."|||5.0|-4.7|
72458137|NCT01250717|144438826|SUPERIORITY_OR_OTHER||Percentage|0.0|||||TWO_SIDED|95.0|0.0|0.12||||||||0.12|0|
72458138|NCT02164578|144438827|SUPERIORITY|||||||0.004|||||||ANCOVA|ANCOVA for repeated measurements with baseline as covariate||The hypothesis H0 is tested against the one-sided alternative hypothesis H1 H0: µ∆FBF,Riva, week 20 ≤ µ∆FBF, ASA, week 20 versus H1: µΔFBF, Riva, week 20 \> µΔFBF, ASA, week 20 by test procedures for continuous data.||||0.004
72458139|NCT02164578|144438828|OTHER|||||||0.07|||||||ANCOVA|||||||0.070
72458140|NCT02164578|144438829|OTHER|||||||0.045|||||||ANCOVA|ANCOVA for repeated measurements with baseline as covariate||||||0.045
72458141|NCT02164578|144438830|OTHER|||||||0.125|||||||ANCOVA|||||||0.125
72458142|NCT02164578|144438831|OTHER|||||||0.217|||||||Wilcoxon (Mann-Whitney)|||||||0.217
72458143|NCT02164578|144438832|OTHER|||||||0.589|||||||Wilcoxon (Mann-Whitney)|||||||0.589
72458144|NCT02507297|144438837|SUPERIORITY|||||||0.367|||||||t-test, 2 sided|||Baseline to 8 weeks after baseline||||.367
72458145|NCT02507297|144438837|SUPERIORITY|||||||0.48|||||||t-test, 2 sided|||Baseline to 12 weeks postpartum||||.48
72500393|NCT03193866|144530972|SUPERIORITY||Mean Difference (Final Values)|-0.2|||||TWO_SIDED|95.0|-2.9|2.5||||||Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||2.5|-2.9|
72500394|NCT03193866|144530972|SUPERIORITY||Mean Difference (Final Values)|-1.1|||||TWO_SIDED|95.0|-4.0|1.8||||||Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||1.8|-4.0|
72458146|NCT02507297|144438838|SUPERIORITY|||||||0.136|||||||t-test, 2 sided|||Baseline to 8 weeks after baseline||||.136
72458147|NCT02507297|144438838|SUPERIORITY|||||||0.324|||||||t-test, 2 sided|||Baseline to 12 weeks postpartum||||.324
72458148|NCT02507297|144438839|SUPERIORITY|||||||0.916|||||||t-test, 2 sided|||Baseline to 8 weeks after baseline||||.916
72458149|NCT02507297|144438839|SUPERIORITY|||||||0.752|||||||t-test, 2 sided|||Baseline to 12 weeks postpartum||||.752
72458150|NCT02507297|144438840|SUPERIORITY|||||||0.568|||||||t-test, 2 sided|||Baseline to 8 weeks after baseline||||.568
72458151|NCT02507297|144438840|SUPERIORITY|||||||0.568|||||||t-test, 2 sided|||Baseline to 12 weeks postpartum||||.568
72458152|NCT02507297|144438841|SUPERIORITY|||||||0.486|||||||t-test, 2 sided|||||||.486
72458153|NCT00113529|144438878|SUPERIORITY_OR_OTHER||Objective Response Rate (ORR) (percent)|37.1||||||95.0|21.5|55.1|||||ORR=proportion of subjects with confirmed CR or PR, relative to total subjects who received at least 1 dose of study medication, had a baseline disease assessment, and had the correct histological cancer type.|||55.1|21.5|
72458154|NCT00113529|144438884|SUPERIORITY_OR_OTHER||probability|82.4||||||95.0|64.9|91.7||||||||91.7|64.9|
72458155|NCT00113529|144438893|SUPERIORITY_OR_OTHER|||||||0.075||95.0|||||Wilcoxon Rank Sum Test|||Cycle 1, Day 1||||0.075
72458156|NCT00113529|144438893|SUPERIORITY_OR_OTHER|||||||0.749||95.0|||||Wilcoxon Rank Sum Test|||Cycle 1, Day 28||||0.749
72458157|NCT00113529|144438893|SUPERIORITY_OR_OTHER|||||||0.834||95.0|||||Wilcoxon Rank Sum Test|||Cycle 2, Day 1||||0.834
72458158|NCT00113529|144438893|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Wilcoxon Rank Sum Test|||Cycle 2, Day 28||||1.000
72458159|NCT00113529|144438893|SUPERIORITY_OR_OTHER|||||||0.332||95.0|||||Wilcoxon Rank Sum Test|||Cycle 3, Day 1||||0.332
72458160|NCT00113529|144438894|SUPERIORITY_OR_OTHER|||||||0.473||95.0|||||Wilcoxon Rank Sum Test|||Cycle 1, Day 1||||0.473
72458161|NCT00113529|144438894|SUPERIORITY_OR_OTHER|||||||0.286||95.0|||||Wilcoxon Rank Sum Test|||Cycle 1, Day 28||||0.286
72458162|NCT00113529|144438894|SUPERIORITY_OR_OTHER|||||||0.277||95.0|||||Wilcoxon Rank Sum Test|||Cycle 2, Day 1||||0.277
72458163|NCT00113529|144438894|SUPERIORITY_OR_OTHER|||||||0.956||95.0|||||Wilcoxon Rank Sum Test|||Cycle 2, Day 28||||0.956
72458164|NCT00113529|144438894|SUPERIORITY_OR_OTHER|||||||0.278||95.0|||||Wilcoxon Rank Sum Test|||Cycle 3, Day 1||||0.278
72458165|NCT00113529|144438895|SUPERIORITY_OR_OTHER|||||||0.275||95.0|||||Wilcoxon Rank Sum Test|||Cycle 1, Day 1||||0.275
72458166|NCT00113529|144438895|SUPERIORITY_OR_OTHER|||||||0.227||95.0|||||Wilcoxon Rank Sum Test|||Cycle 1, Day 28||||0.227
72458167|NCT00113529|144438895|SUPERIORITY_OR_OTHER|||||||0.029||95.0|||||Wilcoxon Rank Sum Test|||Cycle 2, Day 1||||0.029
72458168|NCT00113529|144438895|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Wilcoxon Rank Sum Test|||Cycle 2, Day 28||||1.000
72458169|NCT00113529|144438895|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Wilcoxon Rank Sum Test|||Cycle 3, Day 1||||1.000
72458170|NCT00113529|144438896|SUPERIORITY_OR_OTHER|||||||0.435||95.0|||||Wilcoxon Rank Sum Test|||Cycle 1, Day 1||||0.435
72458171|NCT00113529|144438896|SUPERIORITY_OR_OTHER|||||||0.722||95.0|||||Wilcoxon Rank Sum Test|||Cycle 1, Day 28||||0.722
72458172|NCT00113529|144438896|SUPERIORITY_OR_OTHER|||||||0.645||95.0|||||Wilcoxon Rank Sum Test|||Cycle 2, Day 1||||0.645
72458173|NCT00113529|144438896|SUPERIORITY_OR_OTHER|||||||0.14||95.0|||||Wilcoxon Rank Sum Test|||Cycle 2, Day 28||||0.140
72458174|NCT00113529|144438896|SUPERIORITY_OR_OTHER|||||||0.046||95.0|||||Wilcoxon Rank Sum Test|||Cycle 3, Day 1||||0.046
72458175|NCT00113529|144438897|SUPERIORITY_OR_OTHER|||||||0.734||95.0|||||Wilcoxon Rank Sum Test|||Cycle 1, Day 1||||0.734
72458176|NCT00113529|144438897|SUPERIORITY_OR_OTHER|||||||0.854||95.0|||||Wilcoxon Rank Sum Test|||Cycle 1, Day 28||||0.854
72458177|NCT00113529|144438897|SUPERIORITY_OR_OTHER|||||||0.23||95.0|||||Wilcoxon Rank Sum Test|||Cycle 2, Day 1||||0.230
72458178|NCT00113529|144438897|SUPERIORITY_OR_OTHER|||||||0.067||95.0|||||Wilcoxon Rank Sum Test|||Cycle 2, Day 28||||0.067
72458179|NCT00113529|144438897|SUPERIORITY_OR_OTHER|||||||0.164||95.0|||||Wilcoxon Rank Sum Test|||Cycle 3, Day 1||||0.164
72458180|NCT00113529|144438897|SUPERIORITY_OR_OTHER|||||||0.121||95.0|||||Wilcoxon Rank Sum Test|||Cycle 3, Day 28||||0.121
72458181|NCT00113529|144438898|SUPERIORITY_OR_OTHER|||||||0.734||95.0|||||Wilcoxon Rank Sum Test|||Cycle 1, Day 1||||0.734
72458182|NCT00113529|144438898|SUPERIORITY_OR_OTHER|||||||0.462||95.0|||||Wilcoxon Rank Sum Test|||Cycle 1, Day 28||||0.462
72458183|NCT00113529|144438898|SUPERIORITY_OR_OTHER|||||||0.423||95.0|||||Wilcoxon Rank Sum Test|||Cycle 2, Day 1||||0.423
72458184|NCT00113529|144438898|SUPERIORITY_OR_OTHER|||||||0.51||95.0|||||Wilcoxon Rank Sum Test|||Cycle 2, Day 28||||0.510
72620852|NCT01887600|144772758|SUPERIORITY||Least squares mean difference|1.563|||<|0.001|TWO_SIDED|95.0|1.15|1.97||LSM Difference p-value is for test of differences.|Mixed Models Analysis|||Hb change from BL to week 96. A Mixed Model of Repeated Measures was applied. The results were based on the estimated difference between the two treatment arms by visit. The model included treatment arm, region, CV history, visits and visit by treatment as categorical variables and baseline Hb and baseline eGFR as continuous variables.||1.97|1.15|<0.001
72458185|NCT00113529|144438898|SUPERIORITY_OR_OTHER|||||||0.608||95.0|||||Wilcoxon Rank Sum Test|||Cycle 3, Day 1||||0.608
72458186|NCT00113529|144438898|SUPERIORITY_OR_OTHER|||||||0.121||95.0|||||Wilcoxon Rank Sum Test|||Cycle 3, Day 28||||0.121
72458187|NCT00113529|144438899|SUPERIORITY_OR_OTHER|||||||0.91||95.0|||||Wilcoxon Rank Sum Test|||Cycle 1, Day 1||||0.910
72458188|NCT00113529|144438899|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||Wilcoxon Rank Sum Test|||Cycle 1, Day 28||||0.020
72458189|NCT00113529|144438899|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Wilcoxon Rank Sum Test|||Cycle 2, Day 1||||1.000
72458190|NCT00113529|144438899|SUPERIORITY_OR_OTHER|||||||0.509||95.0|||||Wilcoxon Rank Sum Test|||Cycle 2, Day 28||||0.509
72458191|NCT00113529|144438899|SUPERIORITY_OR_OTHER|||||||0.883||95.0|||||Wilcoxon Rank Sum Test|||Cycle 3, Day 1||||0.883
72458192|NCT00113529|144438899|SUPERIORITY_OR_OTHER|||||||0.582||95.0|||||Wilcoxon Rank Sum Test|||Cycle 3, Day 28||||0.582
72458193|NCT00113529|144438900|SUPERIORITY_OR_OTHER|||||||0.428||95.0|||||Wilcoxon Rank Sum Test|||Cycle 1, Day 1||||0.428
72458194|NCT00113529|144438900|SUPERIORITY_OR_OTHER|||||||0.075||95.0|||||Wilcoxon Rank Sum Test|||Cycle 1, Day 28||||0.075
72458195|NCT00113529|144438900|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Wilcoxon Rank Sum Test|||Cycle 2, Day 1||||1.000
72458196|NCT00113529|144438900|SUPERIORITY_OR_OTHER|||||||0.019||95.0|||||Wilcoxon Rank Sum Test|||Cycle 2, Day 28||||0.019
72458197|NCT00113529|144438900|SUPERIORITY_OR_OTHER|||||||0.124||95.0|||||Wilcoxon Rank Sum Test|||Cycle 3, Day 1||||0.124
72458198|NCT00113529|144438900|SUPERIORITY_OR_OTHER|||||||0.055||95.0|||||Wilcoxon Rank Sum Test|||Cycle 3, Day 28||||0.055
72458199|NCT00113529|144438901|SUPERIORITY_OR_OTHER|||||||0.734||95.0|||||Wilcoxon Rank Sum Test|||Cycle 1, Day 1||||0.734
72458200|NCT00113529|144438901|SUPERIORITY_OR_OTHER|||||||0.854||95.0|||||Wilcoxon Rank Sum Test|||Cycle 1, Day 28||||0.854
72458201|NCT00113529|144438901|SUPERIORITY_OR_OTHER|||||||0.23||95.0|||||Wilcoxon Rank Sum Test|||Cycle 2, Day 1||||0.230
72458202|NCT00113529|144438901|SUPERIORITY_OR_OTHER|||||||0.067||95.0|||||Wilcoxon Rank Sum Test|||Cycle 2, Day 28||||0.067
72458203|NCT00113529|144438901|SUPERIORITY_OR_OTHER|||||||0.164||95.0|||||Wilcoxon Rank Sum Test|||Cycle 3, Day 1||||0.164
72458204|NCT00113529|144438901|SUPERIORITY_OR_OTHER|||||||0.121||95.0|||||Wilcoxon Rank Sum Test|||Cycle 3, Day 28||||0.121
72458205|NCT00113529|144438902|SUPERIORITY_OR_OTHER|||||||0.734||95.0|||||Wilcoxon Rank Sum Test|||Cycle 1, Day 1||||0.734
72458206|NCT00113529|144438902|SUPERIORITY_OR_OTHER|||||||0.462||95.0|||||Wilcoxon Rank Sum Test|||Cycle 1, Day 28||||0.462
72458207|NCT00113529|144438902|SUPERIORITY_OR_OTHER|||||||0.423||95.0|||||Wilcoxon Rank Sum Test|||Cycle 2, Day 1||||0.423
72458208|NCT00113529|144438902|SUPERIORITY_OR_OTHER|||||||0.51||95.0|||||Wilcoxon Rank Sum Test|||Cycle 2, Day 28||||0.510
72458209|NCT00113529|144438902|SUPERIORITY_OR_OTHER|||||||0.608||95.0|||||Wilcoxon Rank Sum Test|||Cycle 3, Day 1||||0.608
72458210|NCT00113529|144438902|SUPERIORITY_OR_OTHER|||||||0.121||95.0|||||Wilcoxon Rank Sum Test|||Cycle 3, Day 28||||0.121
72458211|NCT00113529|144438903|SUPERIORITY_OR_OTHER|||||||0.91||95.0|||||Wilcoxon Rank Sum Test|||Cycle 1, Day 1||||0.910
72458212|NCT00113529|144438903|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||Wilcoxon Rank Sum Test|||Cycle 1, Day 28||||0.020
72458213|NCT00113529|144438903|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Wilcoxon Rank Sum Test|||Cycle 2, Day 1||||1.000
72458214|NCT00113529|144438903|SUPERIORITY_OR_OTHER|||||||0.509||95.0|||||Wilcoxon Rank Sum Test|||Cycle 2, Day 28||||0.509
72458215|NCT00113529|144438903|SUPERIORITY_OR_OTHER|||||||0.883||95.0|||||Wilcoxon Rank Sum Test|||Cycle 3, Day 1||||0.883
72458216|NCT00113529|144438903|SUPERIORITY_OR_OTHER|||||||0.582||95.0|||||Wilcoxon Rank Sum Test|||Cycle 3, Day 28||||0.582
72458217|NCT00113529|144438904|SUPERIORITY_OR_OTHER|||||||0.428||95.0|||||Wilcoxon Rank Sum Test|||Cycle 1, Day 1||||0.428
72458218|NCT00113529|144438904|SUPERIORITY_OR_OTHER|||||||0.075||95.0|||||Wilcoxon Rank Sum Test|||Cycle 1, Day 28||||0.075
72458219|NCT00113529|144438904|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Wilcoxon Rank Sum Test|||Cycle 2, Day 1||||1.000
72458220|NCT00113529|144438904|SUPERIORITY_OR_OTHER|||||||0.019||95.0|||||Wilcoxon Rank Sum Test|||Cycle 2, Day 28||||0.019
72458221|NCT00113529|144438904|SUPERIORITY_OR_OTHER|||||||0.124||95.0|||||Wilcoxon Rank Sum Test|||Cycle 3, Day 1||||0.124
72458222|NCT00113529|144438904|SUPERIORITY_OR_OTHER|||||||0.055||95.0|||||Wilcoxon Rank Sum Test|||Cycle 3, Day 28||||0.055
72458223|NCT02791308|144438917|EQUIVALENCE|Proportion of Subjects with Treatment Success at Visit 4/Day 15|Other|0.407|||||TWO_SIDED|90.0|-15.57|3.53||||||Percentage of Subjects with Treatment Success at Visit 4/Day 15||3.53|-15.57|
72458224|NCT00795639|144438926|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.0||||0.0104|TWO_SIDED|95.0|3.0|26.0||Significance test performed using non-parametric analysis of covariance controlling for Baseline 6MWD and PAH etiology and PAH not secondary to a connective tissue disease (other).|ANCOVA||Missing value at Week 12 assigned as zero if the subject had a predefined clinical worsening event, otherwise, missing value at Week 12 imputed with the last non-missing 6MWD based on LOCF.|||26|3|0.0104
72458225|NCT00795639|144438927|SUPERIORITY_OR_OTHER|||||||0.2908|TWO_SIDED|||||Significance tests of WHO Functional Class performed using the Cochran-Mantel-Haenszel (CMH) test, stratified by Baseline 6MWD (less than 310 meters and greater than or equal to 310 meters) and PAH Etiology (Connective Tissue Disease and others).|Cochran-Mantel-Haenszel|The CMH test used modified ridit scores, and the p-value corresponding to ANCOVA (row mean scores) statistics were used.||Week 12||||0.2908
72458226|NCT00674765|144438936|SUPERIORITY_OR_OTHER|||||||0.388|||||||t-test, 2 sided|t=.87||||||.388
72458227|NCT04421456|144438937|SUPERIORITY|The repeated measures model includes stratification factors (sex and region), associated baseline, visit, randomised treatment arm and visit by treatment arm interaction as fixed effects and visit repeated within each participant as a repeated effect. For the PANSS-T score, baseline PANSS-P, baseline PANSS-N, and baseline PANSS-G are included in the model as fixed effects for the associated baseline instead of baseline PANSS-T.|Least square mean difference|-1.75|STANDARD_ERROR_OF_MEAN|2.33||0.4528|TWO_SIDED|95.0|-6.35|2.84|||Mixed-effects repeated measures model|||||2.84|-6.35|0.4528
72458228|NCT04421456|144438937|SUPERIORITY|The repeated measures model includes stratification factors (sex and region), associated baseline, visit, randomised treatment arm and visit by treatment arm interaction as fixed effects and visit repeated within each participant as a repeated effect. For the PANSS-T score, baseline PANSS-P, baseline PANSS-N, and baseline PANSS-G are included in the model as fixed effects for the associated baseline instead of baseline PANSS-T.|Least square mean difference|-1.96|STANDARD_ERROR_OF_MEAN|2.44||0.4226|TWO_SIDED|95.0|-6.76|2.85|||Mixed-effects repeated measures model|||||2.85|-6.76|0.4226
72458229|NCT04421456|144438938|SUPERIORITY|The repeated measures model includes stratification factors (sex and region), associated baseline, visit, randomised treatment arm and visit by treatment arm interaction as fixed effects and visit repeated within each participant as a repeated effect.|Least square mean difference|-0.63|STANDARD_ERROR_OF_MEAN|0.83||0.4479|TWO_SIDED|95.0|-2.25|1.0|||Mixed-effects repeated measures model|||||1.00|-2.25|0.4479
72458230|NCT04421456|144438938|SUPERIORITY|The repeated measures model includes stratification factors (sex and region), associated baseline, visit, randomised treatment arm and visit by treatment arm interaction as fixed effects and visit repeated within each participant as a repeated effect.|Least square mean difference|-1.22|STANDARD_ERROR_OF_MEAN|0.87||0.1616|TWO_SIDED|95.0|-2.92|0.49|||Mixed-effects repeated measures model|||||0.49|-2.92|0.1616
72500395|NCT03193866|144530972|SUPERIORITY||Mean Difference (Final Values)|-3.1|||||TWO_SIDED|95.0|-7.0|0.9||||||Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||0.9|-7.0|
72500396|NCT03193866|144530972|SUPERIORITY||Mean Difference (Final Values)|1.3|||||TWO_SIDED|95.0|-2.9|5.4||||||Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||5.4|-2.9|
72458231|NCT04421456|144438939|SUPERIORITY|The repeated measures model includes stratification factors (sex and region), associated baseline, visit, randomised treatment arm and visit by treatment arm interaction as fixed effects and visit repeated within each participant as a repeated effect.|Least square mean difference|-0.31|STANDARD_ERROR_OF_MEAN|0.76||0.6787|TWO_SIDED|95.0|-1.8|1.18|||Mixed-effects repeated measures model|||||1.18|-1.80|0.6787
72500397|NCT03193866|144530973|SUPERIORITY||Mean Difference (Final Values)|-5.5|||||TWO_SIDED|95.0|-8.1|-2.9||||||Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||-2.9|-8.1|
72458232|NCT04421456|144438939|SUPERIORITY|The repeated measures model includes stratification factors (sex and region), associated baseline, visit, randomised treatment arm and visit by treatment arm interaction as fixed effects and visit repeated within each participant as a repeated effect.|Least square mean difference|0.76|STANDARD_ERROR_OF_MEAN|0.78||0.3351|TWO_SIDED|95.0|-0.79|2.3|||Mixed-effects repeated measures model|||||2.30|-0.79|0.3351
72458233|NCT04421456|144438940|SUPERIORITY|The repeated measures model includes stratification factors (sex and region), associated baseline, visit, randomised treatment arm and visit by treatment arm interaction as fixed effects and visit repeated within each participant as a repeated effect.|Least square mean difference|-1.1|STANDARD_ERROR_OF_MEAN|1.45||0.4504|TWO_SIDED|95.0|-3.96|1.76|||Mixed-effects repeated measures model|||||1.76|-3.96|0.4504
72458234|NCT04421456|144438940|SUPERIORITY|The repeated measures model includes stratification factors (sex and region), associated baseline, visit, randomised treatment arm and visit by treatment arm interaction as fixed effects and visit repeated within each participant as a repeated effect.|Least square mean difference|-1.23|STANDARD_ERROR_OF_MEAN|1.52||0.4195|TWO_SIDED|95.0|-4.22|1.76|||Mixed-effects repeated measures model|||||1.76|-4.22|0.4195
72458235|NCT04421456|144438941|SUPERIORITY|The repeated measures model includes stratification factors (sex and region), associated baseline, visit, randomised treatment arm, visit by treatment arm interaction and visit by associated baseline interaction as fixed effects and visit repeated within each participant as a repeated effect.|Least square mean difference|0.02|STANDARD_ERROR_OF_MEAN|0.16||0.885|TWO_SIDED|95.0|-0.35|0.3|||Mixed-effects repeated measures model|||||0.30|-0.35|0.8850
72458236|NCT04421456|144438941|SUPERIORITY|The repeated measures model includes stratification factors (sex and region), associated baseline, visit, randomised treatment arm, visit by treatment arm interaction and visit by associated baseline interaction as fixed effects and visit repeated within each participant as a repeated effect.|Least square mean difference|0.04|STANDARD_ERROR_OF_MEAN|0.16||0.7808|TWO_SIDED|95.0|-0.36|0.27|||Mixed-effects repeated measures model|||||0.27|-0.36|0.7808
72458237|NCT04421456|144438942|SUPERIORITY||Odds Ratio (OR)|1.412||||0.6707|TWO_SIDED|95.0|0.288|6.924|||Regression, Logistic|||||6.924|0.288|0.6707
72392487|NCT00790023|144292394|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.87|||<|0.0001|TWO_SIDED|95.0|0.5|1.25|||ANCOVA|||Dmitrienko's tree-structured gatekeeping method was used for multiple comparisons||1.25|0.50|<0.0001
72458238|NCT04421456|144438942|SUPERIORITY||Odds Ratio (OR)|0.576||||0.4883|TWO_SIDED|95.0|0.121|2.744|||Regression, Logistic|||||2.744|0.121|0.4883
72458239|NCT01694199|144438958|SUPERIORITY_OR_OTHER|||||||0.3529|||||||ANCOVA|||||||0.3529
72458240|NCT01694199|144438959|SUPERIORITY_OR_OTHER|||||||0.2766|||||||ANCOVA|||||||0.2766
72458241|NCT01694199|144438960|SUPERIORITY_OR_OTHER|||||||0.1467|||||||ANOVA|||P=0.1467||||0.1467
72458242|NCT01694199|144438961|SUPERIORITY_OR_OTHER|||||||0.5009|||||||ANOVA|||P = 0.5009||||0.5009
72458243|NCT01694199|144438962|SUPERIORITY_OR_OTHER|||||||0.9038|||||||ANOVA|||||||0.9038
72458244|NCT01930188|144439007|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was concluded if the upper limit of the two-sided 95% confidence interval for the estimated treatment difference between semaglutide 1.0 mg and sitagliptin was below the pre-specified non-inferiority margin (0.3 %).|treatment difference|-1.06|||<|0.0001|TWO_SIDED|95.0|-1.21|-0.91|||Mixed Models Analysis|Post-baseline responses analysed with mixed model for repeated measurements-treatment \& country (fixed) \& baseline (covariate) all nested within visit||||-0.91|-1.21|<0.0001
72458245|NCT01930188|144439007|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was concluded if the upper limit of the two-sided 95% confidence interval for the estimated treatment difference between semaglutide 0.5 mg and sitagliptin was below the pre-specified non-inferiority margin (0.3 %).|treatment difference|-0.92|||<|0.0001|TWO_SIDED|95.0|-1.21|-0.62|||Mixed Models Analysis|Analysis done with mixed model for repeated measurements (treatment \& country as fixed factors \& baseline value as covariate) all nested within visit||||-0.62|-1.21|<0.0001
72458246|NCT02841449|144439018|OTHER|||||||0.886|||||||t-test, 2 sided|paired sample||||||0.886
72458247|NCT02841449|144439018|OTHER|||||||0.43||||||The above is the trial\*time interaction. trial, p = 0.627; time, p \< 0.001|ANOVA|repeated measures||||||0.430
72458248|NCT02841449|144439019|OTHER|||||||0.369|||||||t-test, 2 sided|paired samples||||||0.369
72392488|NCT00790023|144292394|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.0|||<|0.0001|TWO_SIDED|95.0|0.63|1.37|||ANCOVA|||Dmitrienko's tree-structured gatekeeping method was used for multiple comparisons||1.37|0.63|<0.0001
72458249|NCT02841449|144439019|OTHER|||||||0.859||||||The above is the trial\*time interaction. trial p = 0.200; time p \< 0.001|ANOVA|repeated measures||||||0.859
72458250|NCT02841449|144439020|OTHER||||||<|0.001|||||||t-test, 2 sided|paired samples||||||<0.001
72458251|NCT02841449|144439020|OTHER|||||||0.261||||||The above is the trial\*time interaction. trial p = 0.002; time p = 0.282|ANOVA|repeated measures||||||0.261
72458252|NCT02841449|144439021|OTHER|||||||0.736|||||||t-test, 2 sided|paired samples||||||0.736
72458253|NCT02841449|144439022|OTHER|||||||0.542|||||||t-test, 2 sided|paired samples||||||0.542
72458254|NCT02841449|144439023|OTHER|||||||0.4|||||||t-test, 2 sided|paired samples||||||0.400
72458255|NCT02841449|144439024|OTHER|||||||0.646|||||||ANOVA|repeated measures||Visual analogue scale for thirst||||0.646
72458256|NCT02841449|144439024|OTHER|||||||0.403|||||||ANOVA|repeated measures||visual analogue scale for desire for savoury||||0.403
72458257|NCT02841449|144439024|OTHER|||||||0.022|||||||ANOVA|repeated measures||visual analogue scale for desire for salt||||0.022
72458258|NCT02841449|144439024|OTHER|||||||0.849|||||||ANOVA|repeated measures||visual analogue scale for hunger||||0.849
72458259|NCT02841449|144439024|OTHER|||||||0.062|||||||ANOVA|repeated measures||visual analogue scale for fullness||||0.062
72458260|NCT02841449|144439024|OTHER|||||||0.549|||||||ANOVA|repeated measures||visual analogue scale for how much participants felt they could eat||||0.549
72458261|NCT02841449|144439024|OTHER|||||||0.402|||||||ANOVA|repeated measures||visual analogue scale for sweet desire||||0.402
72458262|NCT02841449|144439024|OTHER|||||||0.138|||||||ANOVA|repeated measures||visual analogue scale for fatty food desire||||0.138
72458263|NCT02841449|144439025|OTHER|||||||0.055||||||Above is trial\*time effect. trial p = 0.135; time p = 0.011|ANOVA|repeated measures||||||0.055
72458264|NCT02841449|144439026|OTHER|||||||0.226|||||||t-test, 2 sided|paired sample||||||0.226
72458265|NCT02841449|144439027|OTHER||||||<|0.001|||||||t-test, 2 sided|paired samples||||||< 0.001
72458266|NCT01020435|144439032|OTHER||Mean Difference (Final Values)|4.1|||||TWO_SIDED|95.0|-0.9|9.2||||||Tx 1 - SBP (Unadjusted)||9.2|-0.9|
72458267|NCT01020435|144439032|OTHER||Mean Difference (Final Values)|2.5|||||TWO_SIDED|95.0|-0.4|5.3||||||Tx 1 - DBP (Unadjusted)||5.3|-0.4|
72458268|NCT01020435|144439032|OTHER||Mean Difference (Final Values)|-0.3|||||TWO_SIDED|95.0|-6.2|5.6||||||Wk 3 - SBP (Unadjusted)||5.6|-6.2|
72458269|NCT01020435|144439032|OTHER||Mean Difference (Final Values)|-0.3|||||TWO_SIDED|95.0|-4.0|3.5||||||Wk 3 - DBP (Unadjusted)||3.5|-4.0|
72458270|NCT01020435|144439032|OTHER||Mean Difference (Final Values)|3.5|||||TWO_SIDED|95.0|-1.9|8.9||||||Wk 6 - SBP (Unadjusted)||8.9|-1.9|
72458271|NCT01020435|144439032|OTHER||Mean Difference (Final Values)|1.5|||||TWO_SIDED|95.0|-2.1|5.0||||||Wk 6 - DBP (Unadjusted)||5.0|-2.1|
72458272|NCT01020435|144439032|OTHER||Mean Difference (Final Values)|4.7|||||TWO_SIDED|95.0|-0.4|9.8||||||Tx 1 - SBP (Adjusted)||9.8|-0.4|
72458273|NCT01020435|144439032|OTHER||Mean Difference (Final Values)|3.6|||||TWO_SIDED|95.0|0.6|6.5||||||Tx 1 - DBP (Adjusted)||6.5|0.6|
72458274|NCT01020435|144439032|OTHER||Mean Difference (Final Values)|0.9|||||TWO_SIDED|95.0|-5.0|6.9||||||Wk 3 - SBP (Adjusted)||6.9|-5.0|
72458275|NCT01020435|144439032|OTHER||Mean Difference (Final Values)|1.0|||||TWO_SIDED|95.0|-2.8|4.9||||||Wk 3 - DBP (Adjusted)||4.9|-2.8|
72458276|NCT01020435|144439032|OTHER||Mean Difference (Final Values)|4.8|||||TWO_SIDED|95.0|-0.4|10.0||||||Wk 6 - SBP (Adjusted)||10.0|-0.4|
72458277|NCT01020435|144439032|OTHER||Mean Difference (Final Values)|2.3|||||TWO_SIDED|95.0|-1.2|5.8||||||Wk 6 - DBP (Adjusted)||5.8|-1.2|
72458278|NCT00346398|144439062|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.3||||0.28|TWO_SIDED|95.0|0.5|10.5||Odds Ratios are calculated using a logistic regression with a Wald chi square test. Experimental group participants had a higher proportion of allergic sensitization than participants who received placebo|Chi-squared|||Participants who drop out (have missing efficacy endpoints) are considered treatment failures.||10.5|0.5|0.28
72458279|NCT00346398|144439063|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.0||||0.85|TWO_SIDED|95.0|0.2|6.1||Odds Ratios are calculated using unadjusted exact logistic regression with mid p-value to adjust for the discreteness of the distribution|Chi-squared|||Participants who drop out (have missing efficacy endpoints) are considered treatment failures.||6.1|0.2|0.85
72458280|NCT00346398|144439064|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.8||||0.28|TWO_SIDED|95.0|0.6|5.6||P-value is calculated using a log-rank test|Regression, Logistic||Hazard ratio and 95% confidence intervals are calculated using an unadjusted Cox regression|||5.6|0.6|0.28
72458281|NCT02607956|144439065|NON_INFERIORITY|A sample of approximately 600 participants randomized 1:1 achieves at least 95% power using a non-inferiority margin of 12% assuming a response rate in both groups of 91% (Reference Genvoya studies) and a one-sided alpha level of 0.025.|Difference in Percentages|-3.5|||||TWO_SIDED|95.002|-7.9|1.0|||||Differences in percentages of participants between groups and their 95.002% CIs were calculated based on Mantel-Haenszel (MH) proportions adjusted by baseline HIV-1 RNA stratum (≤ 100,000 vs. \> 100,000 copies/mL) and region stratum (US vs. Ex-US).|||1.0|-7.9|
72458282|NCT02607956|144439065|SUPERIORITY|||||||0.12|||||||Cochran-Mantel-Haenszel|p-value was calculated from CMH test stratified by baseline HIV-1 RNA stratum (≤ 100,000 vs. \> 100,000 copies/mL) and region stratum (US vs. Ex-US).||||||0.12
72458283|NCT02607956|144439066|OTHER||Difference in Percentages|-2.3|||||TWO_SIDED|95.0|-7.9|3.2|||||Differences in percentages of participants between groups and their 95% CIs were calculated based on MH proportions adjusted by baseline HIV-1 RNA stratum (≤ 100,000 vs. \> 100,000 copies/mL) and region stratum (US vs. Ex-US).|||3.2|-7.9|
72458284|NCT02607956|144439066|OTHER|||||||0.41|||||||Cochran-Mantel-Haenszel|p-value was calculated from CMH test stratified by baseline HIV-1 RNA stratum (≤ 100,000 vs. \> 100,000 copies/mL) and region stratum (US vs. Ex-US).||||||0.41
72458285|NCT02607956|144439067|OTHER||Difference in Percentages|-1.9|||||TWO_SIDED|95.0|-7.8|3.9|||||Differences in percentages of participants between groups and their 95% CIs were calculated based on MH proportions adjusted by baseline HIV-1 RNA stratum (≤ 100,000 vs. \> 100,000 copies/mL) and region stratum (US vs. Ex-US).|||3.9|-7.8|
72392489|NCT00790023|144292395|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.61||||0.0004|TWO_SIDED|95.0|0.28|0.95|||ANCOVA|||Dmitrienko's tree-structured gatekeeping method was used for multiple comparisons||0.95|0.28|0.0004
72458286|NCT02607956|144439067|OTHER|||||||0.52|||||||Cochran-Mantel-Haenszel|p-value was calculated from CMH test stratified by baseline HIV-1 RNA stratum (≤ 100,000 vs. \> 100,000 copies/mL) and region stratum (US vs. Ex-US).||||||0.52
72458287|NCT02607956|144439068|OTHER||Difference in Percentages|-3.9|||||TWO_SIDED|95.0|-9.4|1.5|||||The differences in percentages of participants between treatment groups and their 95% CIs were calculated based on the MH proportions adjusted by baseline HIV-1 RNA stratum (≤ 100,000 vs. \> 100,000 copies/mL) and region stratum (US vs. Ex-US).|||1.5|-9.4|
72458288|NCT02607956|144439068|OTHER|||||||0.16|||||||Cochran-Mantel-Haenszel|p-value was calculated from CMH test stratified by baseline HIV-1 RNA stratum (≤ 100,000 vs. \> 100,000 copies/mL) and region stratum (US vs. Ex-US).||||||0.16
72458289|NCT02607956|144439069|OTHER||Difference in Percentages|-2.5|||||TWO_SIDED|95.0|-8.8|3.8|||||The differences in percentages of participants between treatment groups and their 95% CIs were calculated based on the MH proportions adjusted by baseline HIV-1 RNA stratum (≤ 100,000 vs. \> 100,000 copies/mL) and region stratum (US vs. Ex-US).|||3.8|-8.8|
72458290|NCT02607956|144439069|OTHER|||||||0.44|||||||Cochran-Mantel-Haenszel|p-value was calculated from CMH test stratified by baseline HIV-1 RNA stratum (≤ 100,000 vs. \> 100,000 copies/mL) and region stratum (US vs. Ex-US).||||||0.44
72458291|NCT02607956|144439070|OTHER||Difference in Percentages|-1.1|||||TWO_SIDED|95.0|-7.4|5.3|||||The differences in percentages of participants between treatment groups and their 95% CIs were calculated based on the MH proportions adjusted by baseline HIV-1 RNA stratum (≤ 100,000 vs. \> 100,000 copies/mL) and region stratum (US vs. Ex-US).|||5.3|-7.4|
72458292|NCT02607956|144439070|OTHER|||||||0.74|||||||Cochran-Mantel-Haenszel|p-value was calculated from CMH test stratified by baseline HIV-1 RNA stratum (≤ 100,000 vs. \> 100,000 copies/mL) and region stratum (US vs. Ex-US).||||||0.74
72458293|NCT02607956|144439071|OTHER||Difference in LSM|0.08||||0.081|TWO_SIDED|95.0|-0.01|0.17|||ANOVA|p-value was adjusted by baseline HIV-1 RNA stratum and region stratum.|Difference in least-squares mean (LSM), and its 95% confidence interval (CI) were adjusted by baseline HIV-1 RNA stratum and region stratum.|||0.17|-0.01|0.081
72458294|NCT02607956|144439072|OTHER||Difference in LSM|0.06||||0.18|TWO_SIDED|95.0|-0.03|0.15|||ANOVA|p-value was adjusted by baseline HIV-1 RNA stratum and region stratum.|Difference in LSM, and its 95% CI were adjusted by baseline HIV-1 RNA stratum and region stratum.|||0.15|-0.03|0.18
72458295|NCT02607956|144439073|OTHER||Difference in LSM|0.09||||0.054|TWO_SIDED|95.0|0.0|0.18|||ANOVA|p-value was adjusted by baseline HIV-1 RNA stratum and region stratum.|Difference in LSM, and its 95% CI were adjusted by baseline HIV-1 RNA stratum and region stratum.|||0.18|0.00|0.054
72458296|NCT02607956|144439074|OTHER||Difference in LSM|-23.0||||0.096|TWO_SIDED|95.0|-49.0|4.0|||ANOVA|P-value was adjusted by the baseline HIV-1 RNA and region stratum.|Difference in LSM, and its 95% CI were adjusted by the baseline HIV-1 RNA and region stratum.|||4|-49|0.096
72392490|NCT00790023|144292395|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.6||||0.0005|TWO_SIDED|95.0|0.27|0.94|||ANCOVA|||Dmitrienko's tree-structured gatekeeping method was used for multiple comparisons||0.94|0.27|0.0005
72620853|NCT01887600|144772758|SUPERIORITY||Least squares mean difference|1.448|||<|0.001|TWO_SIDED|95.0|1.06|1.83||LSM Difference p-value is for test of differences.|Mixed Models Analysis|||Hb change from BL to week 100. A Mixed Model of Repeated Measures was applied. The results were based on the estimated difference between the two treatment arms by visit. The model included treatment arm, region, CV history, visits and visit by treatment as categorical variables and baseline Hb and baseline eGFR as continuous variables.||1.83|1.06|<0.001
72500398|NCT03193866|144530973|SUPERIORITY||Mean Difference (Final Values)|-5.9|||||TWO_SIDED|95.0|-10.9|-1.0||||||Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||-1.0|-10.9|
72500399|NCT03193866|144530973|SUPERIORITY||Mean Difference (Final Values)|-2.4|||||TWO_SIDED|95.0|-4.0|-0.8||||||Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||-0.8|-4.0|
72500400|NCT03193866|144530973|SUPERIORITY||Mean Difference (Final Values)|-0.3|||||TWO_SIDED|95.0|-2.1|1.5||||||Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||1.5|-2.1|
72500401|NCT03193866|144530973|SUPERIORITY||Mean Difference (Final Values)|-0.8|||||TWO_SIDED|95.0|-2.2|0.6||||||Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||0.6|-2.2|
72500402|NCT03193866|144530973|SUPERIORITY||Mean Difference (Final Values)|1.3|||||TWO_SIDED|95.0|-0.3|2.8||||||Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||2.8|-0.3|
72500403|NCT03193866|144530973|SUPERIORITY||Mean Difference (Final Values)|2.7|||||TWO_SIDED|95.0|0.9|4.6||||||Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||4.6|0.9|
72500404|NCT03193866|144530973|SUPERIORITY||Mean Difference (Final Values)|2.1|||||TWO_SIDED|95.0|0.2|4.0||||||Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||4.0|0.2|
72500405|NCT04971226|144530980|SUPERIORITY||Risk Difference (RD)|18.88|||<|0.001|TWO_SIDED|95.0|9.59|28.17|||Mantel Haenszel||The Estimate Value is a percentage.||The Confidence Interval are percentages.|28.17|9.59|<0.001
72500406|NCT04971226|144531012|SUPERIORITY||Risk Difference (RD)|29.55|||<|0.001|TWO_SIDED|95.0|16.91|42.18|||Mantel Haenszel||The Estimate Value is a percentage.||The Confidence Interval are percentages.|42.18|16.91|<0.001
72500407|NCT05040971|144531021|SUPERIORITY|Week 52 responses were analysed using an analysis of covariance model (ANCOVA) with randomised treatment as factor and baseline body weight as covariate.|Treatment difference|-11.19|||<|0.0001|TWO_SIDED|95.0|-12.97|-9.42|||ANCOVA|||Treatment policy estimand||-9.42|-12.97|<0.0001
72500408|NCT05040971|144531022|SUPERIORITY|Week 52 responses were analysed using a logistic regression model with randomised treatment as factor and baseline glycosylated haemoglobin (HbA1c) and fasting plasma glucose (FPG) as covariates.|Odds Ratio (OR)|19.81|||<|0.0001|TWO_SIDED|95.0|8.68|45.21|||Regression, Logistic|||Treatment policy estimand||45.21|8.68|<0.0001
72500409|NCT02623972|144531038|OTHER||Pathelogic Complete Response Rate|30.0|||||TWO_SIDED||||||Simon minimax two-stage design||Decision Rule: If the percentage of participants experiencing pathologic complete response (pCR) is ≤ 10% then the preoperative regimen is considered minimally effective. If the proportion of pCR ≥ 30% then the regimen is worthy of further study.|Null Hypothesis: the proportion of participants experiencing pCR is ≤ 0.10, Alternative hypothesis that proportion pCR ≥ 0.30. Hypothesized False Positive Rate(α)=10%; Hypothesized False Negative Rate(1-β)=10%.||||
72500410|NCT02623972|144531038|OTHER||Pathelogic Complete Response Rate|23.0|||||TWO_SIDED||||||Simon minimax two-stage design||Decision Rule: If the percentage of participants experiencing pathologic complete response (pCR) is ≤ 2% then the preoperative regimen is considered minimally effective. If the proportion of pCR ≥ 23% then the regimen is worthy of further study.|Null Hypothesis: the proportion of participants experiencing pCR is ≤ 0.02, Alternative hypothesis that proportion pCR ≥ 0.23. Hypothesized False Positive Rate(α)=5%; Hypothesized False Negative Rate(1-β)=10%.||||
72620854|NCT01887600|144772758|SUPERIORITY||Least squares mean difference|1.347|||<|0.001|TWO_SIDED|95.0|0.9|1.79||LSM Difference p-value is for test of differences.|Mixed Models Analysis|||Hb change from BL to week 104. A Mixed Model of Repeated Measures was applied. The results were based on the estimated difference between the two treatment arms by visit. The model included treatment arm, region, CV history, visits and visit by treatment as categorical variables and baseline Hb and baseline eGFR as continuous variables.||1.79|0.90|<0.001
72458297|NCT02607956|144439075|OTHER||Difference in LSM|-47.0||||0.008|TWO_SIDED|95.0|-81.0|-12.0|||ANOVA|P-value was adjusted by the baseline HIV-1 RNA and region stratum.|Difference in LSM, and its 95% CI were adjusted by the baseline HIV-1 RNA and region stratum.|||-12|-81|0.008
72458298|NCT02607956|144439076|OTHER||Difference in LSM|-14.0||||0.48|TWO_SIDED|95.0|-52.0|25.0|||ANOVA|p-value was adjusted by baseline HIV-1 RNA stratum and region stratum.|Difference in LSM, and its 95% CI were adjusted by baseline HIV-1 RNA stratum and region stratum.|||25|-52|0.48
72458299|NCT02978183|144439121|SUPERIORITY|||||||0.0882||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: Pre-CAC||||0.0882
72458300|NCT02978183|144439121|SUPERIORITY|||||||0.8032||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 5 Minutes Post-CAC||||0.8032
72458301|NCT02978183|144439121|SUPERIORITY|||||||0.9003||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 7 Minutes Post-CAC||||0.9003
72458302|NCT02978183|144439121|SUPERIORITY|||||||0.9523||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 10 Minutes Post-CAC||||0.9523
72458303|NCT02978183|144439121|SUPERIORITY|||||||0.9071||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 15 Minutes Post-CAC||||0.9071
72458304|NCT02978183|144439121|SUPERIORITY|||||||0.7509||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 20 Minutes Post-CAC||||0.7509
72458305|NCT02978183|144439121|SUPERIORITY|||||||0.2824||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 25 Minutes Post-CAC||||0.2824
72458306|NCT02978183|144439121|SUPERIORITY|||||||0.4017||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 30 Minutes Post-CAC||||0.4017
72458307|NCT02978183|144439121|SUPERIORITY|||||||0.4497||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: All Post-CAC Time Points||||0.4497
72563033|NCT00292227|144658111|SUPERIORITY_OR_OTHER||Mean Difference (Net)|9.3||||||95.0|7.57|11.02|||ANOVA|The ANOVA model included the factors treatment, period, sequence, and subject(sequence).|The direction of the estimate is Moxifloxacin - Placebo. Mean difference was estimated from the ANOVA model.|For the analysis of the assay sensitivity, an ANOVA with the factors treatment, period, sequence, and subject(sequence) for comparison of moxifloxacin vs placebo (cross-over comparison) was performed. The point estimates for the difference between placebo and positive control (moxifloxacin) and the respective 95% confidence intervals were calculated.||11.02|7.57|
72458308|NCT02978183|144439121|SUPERIORITY|||||||0.165||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: Pre-CAC||||0.1650
72458309|NCT02978183|144439121|SUPERIORITY|||||||0.3494||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 5 Minutes Post-CAC||||0.3494
72458310|NCT02978183|144439121|SUPERIORITY|||||||0.4781||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 7 Minutes Post-CAC||||0.4781
72458311|NCT02978183|144439121|SUPERIORITY|||||||0.9847||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 10 Minutes Post-CAC||||0.9847
72458312|NCT02978183|144439121|SUPERIORITY|||||||0.9731||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 15 Minutes Post-CAC||||0.9731
72458313|NCT02978183|144439121|SUPERIORITY|||||||0.6984||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 20 Minutes Post-CAC||||0.6984
72458314|NCT02978183|144439121|SUPERIORITY|||||||0.6265||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 25 Minutes Post-CAC||||0.6265
72458315|NCT02978183|144439121|SUPERIORITY|||||||0.7848||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 30 Minutes Post-CAC||||0.7848
72458316|NCT02978183|144439121|SUPERIORITY|||||||0.5789||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: All Post-CAC Time Points||||0.5789
72458317|NCT02978183|144439122|SUPERIORITY|||||||0.8165||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: Pre-CAC||||0.8165
72458318|NCT02978183|144439122|SUPERIORITY|||||||0.659||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 10 Minutes Post-CAC||||0.6590
72620855|NCT01887600|144772759|SUPERIORITY||Least squares mean difference|1.614|||<|0.001|TWO_SIDED|95.0|1.42|1.81||LSM difference p-value is for test of differences.|Mixed Models Analysis|||Change from baseline to average Hb weeks 28-36. A Mixed Model of Repeated Measures was applied using the visits up to week 36. The results were based on the estimated difference between the two treatment arms overall mean effect during week 28 to 36 period based on this MMRM model. The model included treatment arm, region, CV history, visits and visit by treatment as categorical variables and baseline Hb and baseline eGFR as continuous variables.||1.81|1.42|<0.001
72458319|NCT02978183|144439122|SUPERIORITY|||||||0.7455||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 15 Minutes Post-CAC||||0.7455
72458320|NCT02978183|144439122|SUPERIORITY|||||||0.9212||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 20 Minutes Post-CAC||||0.9212
72458321|NCT02978183|144439122|SUPERIORITY|||||||0.9509||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 25 Minutes Post-CAC||||0.9509
72458322|NCT02978183|144439122|SUPERIORITY|||||||0.7897||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 30 Minutes Post-CAC||||0.7897
72458323|NCT02978183|144439122|SUPERIORITY|||||||0.3183||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: All Post-CAC Time Points||||0.3183
72458324|NCT02978183|144439122|SUPERIORITY|||||||0.7604||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: Pre-CAC||||0.7604
72458325|NCT02978183|144439122|SUPERIORITY|||||||0.7343||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 10 Minutes Post-CAC||||0.7343
72458326|NCT02978183|144439122|SUPERIORITY|||||||0.153||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 15 Minutes Post-CAC||||0.1530
72458327|NCT02978183|144439122|SUPERIORITY|||||||0.3307||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 20 Minutes Post-CAC||||0.3307
72458328|NCT02978183|144439122|SUPERIORITY|||||||0.3399||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 25 Minutes Post-CAC||||0.3399
72458329|NCT02978183|144439122|SUPERIORITY|||||||0.5137||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 30 Minutes Post-CAC||||0.5137
72458330|NCT02978183|144439122|SUPERIORITY|||||||0.9962||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: All Post-CAC Time Points||||0.9962
72458331|NCT02978183|144439123|SUPERIORITY|||||||0.3259||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: Pre-CAC||||0.3259
72458332|NCT02978183|144439123|SUPERIORITY|||||||0.9785||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 10 Minutes Post-CAC||||0.9785
72458333|NCT02978183|144439123|SUPERIORITY|||||||0.5112||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 15 Minutes Post-CAC||||0.5112
72458334|NCT02978183|144439123|SUPERIORITY|||||||0.7771||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 20 Minutes Post-CAC||||0.7771
72458335|NCT02978183|144439123|SUPERIORITY|||||||0.6232||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 25 Minutes Post-CAC||||0.6232
72458336|NCT02978183|144439123|SUPERIORITY|||||||0.8895||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 30 Minutes Post-CAC||||0.8895
72458337|NCT02978183|144439123|SUPERIORITY|||||||0.8974||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: All Post-CAC Time Points||||0.8974
72458338|NCT02978183|144439123|SUPERIORITY|||||||0.9604||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: Pre-CAC||||0.9604
72500411|NCT03878147|144531043|SUPERIORITY|The key parameter was difference between least square means of trial arms at month 2.|Mean Difference (Final Values)|2.39|STANDARD_ERROR_OF_MEAN|0.82|<|0.01|TWO_SIDED|95.0|0.78|4.01||P-value was not adjusted for multiple comparisons. A priori threshold for statistical significance was .05.|Mixed Models Analysis|Baseline value of the outcome, child's age, sex, and HIV exposure status were included as covariates.|BPG minus waitlist control.|The null hypothesis was that the means of two arms were equal. The alternative hypothesis was that means of two arms were not equal. With this sample size, differences between arms corresponding to the unadjusted effect size Cohen's d=0.33 would be detectable as statistically significant with power of .80 in two-sided tests at .05 level of significance.||4.01|0.78|<.01
72563034|NCT00292227|144658112|SUPERIORITY_OR_OTHER||Mean Difference (Net)|8.87||||||95.0|7.47|10.28|||ANOVA|The ANOVA model included the factors treatment, period, sequence, and subject(sequence).|The direction of the estimate is Moxifloxacin - Placebo. Mean difference was estimated from the ANOVA model.|For the analysis of the assay sensitivity, an ANOVA with the factors treatment, period, sequence, and subject(sequence) for comparison of moxifloxacin vs placebo (cross-over comparison) was performed. The point estimates for the difference between placebo and positive control (moxifloxacin) and the respective 95% confidence intervals were calculated.||10.28|7.47|
72563035|NCT00292227|144658113|SUPERIORITY_OR_OTHER||Mean Difference (Net)|8.6||||||95.0|7.25|9.96|||ANOVA|The ANOVA model included the factors treatment, period, sequence, and subject(sequence).|The direction of the estimate is Moxifloxacin - Placebo. Mean difference was estimated from the ANOVA model.|For the analysis of the assay sensitivity, an ANOVA with the factors treatment, period, sequence, and subject(sequence) for comparison of moxifloxacin vs placebo (cross-over comparison) was performed. The point estimates for the difference between placebo and positive control (moxifloxacin) and the respective 95% confidence intervals were calculated.||9.96|7.25|
72620856|NCT01887600|144772760|SUPERIORITY||Least squares mean difference|1.594|||<|0.001|TWO_SIDED|95.0|1.38|1.81||LSM Difference p-value is for test of differences.|Mixed Models Analysis|||Change from baseline to average Hb weeks 44-52. A Mixed Model of Repeated Measures was applied using the visits up to week 52. The results were based on the estimated difference between the two treatment arms overall mean effect during week 44 to 52 period based on this MMRM model. The model included treatment arm, region, CV history, visits and visit by treatment as categorical variables and baseline Hb and baseline eGFR as continuous variables.||1.81|1.38|<0.001
72620857|NCT01887600|144772761|SUPERIORITY||Least squares mean difference|1.452|||<|0.001|TWO_SIDED|95.0|1.1|1.8||LSM difference p-value is for test of differences.|Mixed Models Analysis|||Change from BL to average Hb weeks 96-104. A Mixed Model of Repeated Measures was applied using the visits up to week 104. The results were based on the estimated difference between the two treatment arms overall mean effect during week 96 to 104 period based on this MMRM model. The model included treatment arm, region, CV history, visits and visit by treatment as categorical variables and baseline Hb and baseline eGFR as continuous variables.||1.80|1.10|<0.001
72620858|NCT01887600|144772765|SUPERIORITY||Hazard Ratio (HR)|0.945|||=|0.643|TWO_SIDED|95.0|0.74|1.2|||Regression, Cox|||Hazard ratio was calculated using stratified Cox Proportional Hazards Regression stratifying on CV history and region and adjusting on Hb and eGFR at baseline as continuous covariates.||1.20|0.74|=0.643
72458339|NCT02978183|144439123|SUPERIORITY|||||||0.5301||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 10 minutes Post-CAC||||0.5301
72458340|NCT02978183|144439123|SUPERIORITY|||||||0.0386||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 15 Minutes Post-CAC||||0.0386
72458341|NCT02978183|144439123|SUPERIORITY|||||||0.1034||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 20 Minutes Post-CAC||||0.1034
72458342|NCT02978183|144439123|SUPERIORITY|||||||0.0985||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 25 Minutes Post-CAC||||0.0985
72458343|NCT02978183|144439123|SUPERIORITY|||||||0.2342||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 30 Minutes Post-CAC||||0.2342
72458344|NCT02978183|144439123|SUPERIORITY|||||||0.3016||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: All Post-CAC Time Points||||0.3016
72458345|NCT02978183|144439124|SUPERIORITY|||||||0.4927||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: Pre-CAC||||0.4927
72458346|NCT02978183|144439124|SUPERIORITY|||||||0.8686||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 10 minutes Post-CAC||||0.8686
72458347|NCT02978183|144439124|SUPERIORITY|||||||0.5772||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 15 Minutes Post-CAC||||0.5772
72458348|NCT02978183|144439124|SUPERIORITY|||||||0.97||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 20 Minutes Post-CAC||||0.9700
72458349|NCT02978183|144439124|SUPERIORITY|||||||0.7516||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 25 Minutes Post-CAC||||0.7516
72458350|NCT02978183|144439124|SUPERIORITY|||||||0.9532||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 30 Minutes Post-CAC||||0.9532
72458351|NCT02978183|144439124|SUPERIORITY|||||||0.7522||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: All Post-CAC Time Points||||0.7522
72458352|NCT02978183|144439124|SUPERIORITY|||||||0.6804||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: Pre-CAC||||0.6804
72458353|NCT02978183|144439124|SUPERIORITY|||||||0.6267||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 10 Minutes Post-CAC||||0.6267
72458354|NCT02978183|144439124|SUPERIORITY|||||||0.0976||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 15 Minutes Post-CAC||||0.0976
72458355|NCT02978183|144439124|SUPERIORITY|||||||0.4687|||||||ANCOVA|||Day 8: 20 Minutes Post-CAC||||0.4687
72458356|NCT02978183|144439124|SUPERIORITY|||||||0.0421||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 25 Minutes Post-CAC||||0.0421
72458357|NCT02978183|144439124|SUPERIORITY|||||||0.6085||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 30 Minutes Post-CAC||||0.6085
72458358|NCT02978183|144439124|SUPERIORITY|||||||0.9634||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: All Post-CAC Time Points||||0.9634
72458359|NCT02978183|144439125|SUPERIORITY|||||||0.3322||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: Pre-CAC||||0.3322
72458360|NCT02978183|144439125|SUPERIORITY|||||||0.8026||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 10 Minutes Pre-CAC||||0.8026
72458361|NCT02978183|144439125|SUPERIORITY|||||||0.9981||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 15 Minutes Pre-CAC||||0.9981
72458362|NCT02978183|144439125|SUPERIORITY|||||||0.5645||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 20 Minutes Post-CAC||||0.5645
72458363|NCT02978183|144439125|SUPERIORITY|||||||0.5455||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 25 Minutes Post-CAC||||0.5455
72458364|NCT02978183|144439125|SUPERIORITY|||||||0.698||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 30 Minutes Post-CAC||||0.6980
72458365|NCT02978183|144439125|SUPERIORITY|||||||0.6115||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: All Post-CAC Time Points||||0.6115
72620859|NCT01887600|144772767|SUPERIORITY||Hazard Ratio (HR)|0.139|||<|0.001|TWO_SIDED|95.0|0.08|0.23|||Regression, Cox|||Time to start rescue therapy within first 24 weeks. Hazard ratio was calculated using stratified Cox Proportional Hazards Regression stratifying on CV history and region and adjusting on Hb and eGFR at baseline as continuous covariates.||0.23|0.08|<0.001
72458366|NCT02978183|144439125|SUPERIORITY|||||||0.4528||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: Pre-CAC||||0.4528
72458367|NCT02978183|144439125|SUPERIORITY|||||||0.7551||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 10 Minutes Post-CAC||||0.7551
72458368|NCT02978183|144439125|SUPERIORITY|||||||0.5318||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 15 Minutes Post-CAC||||0.5318
72458369|NCT02978183|144439125|SUPERIORITY|||||||0.9748||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 20 Minutes Post-CAC||||0.9748
72458370|NCT02978183|144439125|SUPERIORITY|||||||0.7706||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 25 Minutes Post-CAC||||0.7706
72458371|NCT02978183|144439125|SUPERIORITY|||||||0.3414||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 30 Minutes Post-CAC||||0.3414
72458372|NCT02978183|144439125|SUPERIORITY|||||||0.4361||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: All Post-CAC Time Points||||0.4361
72458373|NCT02978183|144439126|SUPERIORITY|||||||0.0603||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: Pre-CAC||||0.0603
72458374|NCT02978183|144439126|SUPERIORITY|||||||0.4857||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 10 minutes Post-CAC||||0.4857
72458375|NCT02978183|144439126|SUPERIORITY|||||||0.9815||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 15 Minutes Post-CAC||||0.9815
72458376|NCT02978183|144439126|SUPERIORITY|||||||0.6213||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 20 Minutes Post-CAC||||0.6213
72458377|NCT02978183|144439126|SUPERIORITY|||||||0.1831||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 25 Minutes Post-CAC||||0.1831
72458378|NCT02978183|144439126|SUPERIORITY|||||||0.6489||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 30 Minutes Post-CAC||||0.6489
72458379|NCT02978183|144439126|SUPERIORITY|||||||0.2622||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: All Post-CAC Time Points||||0.2622
72458380|NCT02978183|144439126|SUPERIORITY|||||||0.2397||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: Pre-CAC||||0.2397
72458381|NCT02978183|144439126|SUPERIORITY|||||||0.3202||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 10 Minutes Post-CAC||||0.3202
72458382|NCT02978183|144439126|SUPERIORITY|||||||0.2663||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 15 Minutes Post-CAC||||0.2663
72458383|NCT02978183|144439126|SUPERIORITY|||||||0.5672||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 20 Minutes Post-CAC||||0.5672
72458384|NCT02978183|144439126|SUPERIORITY|||||||0.5055||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 25 Minutes Post-CAC||||0.5055
72458385|NCT02978183|144439126|SUPERIORITY|||||||0.8143||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 30 Minutes Post-CAC||||0.8143
72458386|NCT02978183|144439126|SUPERIORITY|||||||0.6901||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: All Post-CAC Time Points||||0.6901
72458387|NCT02978183|144439127|SUPERIORITY|||||||0.4032||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: Pre-CAC||||0.4032
72458388|NCT02978183|144439127|SUPERIORITY|||||||0.2946||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 10 Minutes Post-CAC||||0.2946
72458389|NCT02978183|144439127|SUPERIORITY|||||||0.2863||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 15 Minutes Post-CAC||||0.2863
72458390|NCT02978183|144439127|SUPERIORITY|||||||0.0891||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 20 Minutes Post-CAC||||0.0891
72458391|NCT02978183|144439127|SUPERIORITY|||||||0.5347||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 25 Minutes Post-CAC||||0.5347
72458392|NCT02978183|144439127|SUPERIORITY|||||||0.3733||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 30 Minutes Post-CAC||||0.3733
72458393|NCT02978183|144439127|SUPERIORITY|||||||0.2506||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: All Post-CAC Time Points||||0.2506
72458394|NCT02978183|144439127|SUPERIORITY|||||||0.8667||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: Pre-CAC||||0.8667
72458395|NCT02978183|144439127|SUPERIORITY|||||||0.764||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 10 Minutes Post-CAC||||0.7640
72458396|NCT02978183|144439127|SUPERIORITY|||||||0.8008||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 15 Minutes Post-CAC||||0.8008
72458397|NCT02978183|144439127|SUPERIORITY|||||||0.4729||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 20 Minutes Post-CAC||||0.4729
72458398|NCT02978183|144439127|SUPERIORITY|||||||0.4742||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 25 Minutes Post-CAC||||0.4742
72458399|NCT02978183|144439127|SUPERIORITY|||||||0.2922||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 30 Minutes Post-CAC||||0.2922
72458400|NCT02978183|144439127|SUPERIORITY|||||||0.3657||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: All Post-CAC Time Points||||0.3657
72458401|NCT02978183|144439128|SUPERIORITY|||||||0.66||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: Pre-CAC||||0.6600
72458402|NCT02978183|144439128|SUPERIORITY|||||||0.6877||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 10 minutes Post-CAC||||0.6877
72458403|NCT02978183|144439128|SUPERIORITY|||||||0.334||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 15 Minutes Post-CAC||||0.3340
72458404|NCT02978183|144439128|SUPERIORITY|||||||0.7874||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 20 Minutes Post-CAC||||0.7874
72458405|NCT02978183|144439128|SUPERIORITY|||||||0.3812||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 25 Minutes Post-CAC||||0.3812
72458406|NCT02978183|144439128|SUPERIORITY|||||||0.6987|||||||ANCOVA|||Day 7: 30 Minutes Post-CAC||||0.6987
72458407|NCT02978183|144439128|SUPERIORITY|||||||0.6832||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: All Post-CAC Time Points||||0.6832
72458408|NCT02978183|144439128|SUPERIORITY|||||||0.8521||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: Pre-CAC||||0.8521
72458409|NCT02978183|144439128|SUPERIORITY|||||||0.7516||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 10 Minutes Post-CAC||||0.7516
72620860|NCT01887600|144772768|SUPERIORITY||Cox Proportional Hazard|0.343|||<|0.001|TWO_SIDED|95.0|0.21|0.55|||Regression, Cox|||Hazard ratio was calculated using stratified Cox Proportional Hazards Regression stratifying on CV history and region and adjusting on Hb and eGFR at baseline as continuous covariates.||0.55|0.21|<0.001
72620861|NCT01887600|144772769|SUPERIORITY||Least squares mean difference|-0.045|||=|0.128|TWO_SIDED|95.0|-0.1|0.01|||ANCOVA|||The Analysis of Covariance (ANCOVA) model was applied including treatment as fixed factor, region and history of CV disease as class factors and baseline Hb, baseline eGFR as continuous covariates.||0.01|-0.10|=0.128
72458410|NCT02978183|144439128|SUPERIORITY|||||||0.6252||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 15 Minutes Post-CAC||||0.6252
72458411|NCT02978183|144439128|SUPERIORITY|||||||0.8321||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 20 Minutes Post-CAC||||0.8321
72458412|NCT02978183|144439128|SUPERIORITY|||||||0.8173||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 25 Minutes Post-CAC||||0.8173
72458413|NCT02978183|144439128|SUPERIORITY|||||||0.5445||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 30 Minutes Post-CAC||||0.5445
72458414|NCT02978183|144439128|SUPERIORITY|||||||0.681||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: All Post-CAC Time Points||||0.6810
72458415|NCT02978183|144439129|SUPERIORITY|||||||0.0111||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: Pre-CAC||||0.0111
72458416|NCT02978183|144439129|SUPERIORITY|||||||0.3391||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 10 Minutes Post-CAC||||0.3391
72458417|NCT02978183|144439129|SUPERIORITY|||||||0.239||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 15 Minutes Post-CAC||||0.2390
72458418|NCT02978183|144439129|SUPERIORITY|||||||0.3068||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 20 Minutes Post-CAC||||0.3068
72458419|NCT02978183|144439129|SUPERIORITY|||||||0.4914||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 25 Minutes Post-CAC||||0.4914
72458420|NCT02978183|144439129|SUPERIORITY|||||||0.5185||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 30 Minutes Post-CAC||||0.5185
72458421|NCT02978183|144439129|SUPERIORITY|||||||0.5262||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: All Post-CAC Time Points||||0.5262
72458422|NCT02978183|144439129|SUPERIORITY|||||||0.6098||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: Pre-CAC||||0.6098
72458423|NCT02978183|144439129|SUPERIORITY|||||||0.8849||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 10 Minutes Post-CAC||||0.8849
72458424|NCT02978183|144439129|SUPERIORITY|||||||0.6941||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 15 Minutes Post-CAC||||0.6941
72458425|NCT02978183|144439129|SUPERIORITY|||||||0.5728||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 20 Minutes Post-CAC||||0.5728
72458426|NCT02978183|144439129|SUPERIORITY|||||||0.5931||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 25 Minutes Post-CAC||||0.5931
72620862|NCT01887600|144772770|SUPERIORITY||Least squares mean difference|-10.429|||=|0.183|TWO_SIDED|95.0|-25.81|4.95|||ANCOVA|||The Analysis of Covariance (ANCOVA) model was applied included treatment arm, region, CV history as categorical variables and baseline Hb and baseline eGFR as continuous variables.||4.95|-25.81|=0.183
72458427|NCT02978183|144439129|SUPERIORITY|||||||0.7513||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 30 Minutes Post-CAC||||0.7513
72458428|NCT02978183|144439129|SUPERIORITY|||||||0.7297||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: All Post-CAC Time Points||||0.7297
72458429|NCT02978183|144439130|SUPERIORITY|||||||0.1259||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: Pre-CAC||||0.1259
72458430|NCT02978183|144439130|SUPERIORITY|||||||0.9234||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 10 Minutes Post-CAC||||0.9234
72458431|NCT02978183|144439130|SUPERIORITY|||||||0.8816||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 15 Minutes Post-CAC||||0.8816
72458432|NCT02978183|144439130|SUPERIORITY|||||||0.5703||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 20 Minutes Post-CAC||||0.5703
72458433|NCT02978183|144439130|SUPERIORITY|||||||0.5428||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 25 Minutes Post-CAC||||0.5428
72458434|NCT02978183|144439130|SUPERIORITY|||||||0.7454||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 30 Minutes Post-CAC||||0.7454
72458435|NCT02978183|144439130|SUPERIORITY|||||||0.8195||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: All Post-CAC Time Points||||0.8195
72458436|NCT02978183|144439130|SUPERIORITY|||||||0.0909||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: Pre-CAC||||0.0909
72458437|NCT02978183|144439130|SUPERIORITY|||||||0.4881||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 10 Minutes Post-CAC||||0.4881
72458438|NCT02978183|144439130|SUPERIORITY|||||||0.3391||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 15 Minutes Post-CAC||||0.3391
72458439|NCT02978183|144439130|SUPERIORITY|||||||0.6065||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 20 Minutes Post-CAC||||0.6065
72458440|NCT02978183|144439130|SUPERIORITY|||||||0.3393||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 25 Minutes Post-CAC||||0.3393
72458441|NCT02978183|144439130|SUPERIORITY|||||||0.8364||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 30 Minutes Post-CAC||||0.8364
72458442|NCT02978183|144439130|SUPERIORITY|||||||0.8858||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: All Post-CAC Time Points||||0.8858
72458443|NCT02978183|144439131|SUPERIORITY|||||||0.8818||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: Pre-CAC||||0.8818
72458444|NCT02978183|144439131|SUPERIORITY|||||||0.8679||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 10 minutes Post-CAC||||0.8679
72458445|NCT02978183|144439131|SUPERIORITY|||||||0.7856||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 15 Minutes Post-CAC||||0.7856
72458446|NCT02978183|144439131|SUPERIORITY|||||||0.7507||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 20 Minutes Post-CAC||||0.7507
72458447|NCT02978183|144439131|SUPERIORITY|||||||0.8189||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 25 Minutes Post-CAC||||0.8189
72458448|NCT02978183|144439131|SUPERIORITY|||||||0.9206||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 30 Minutes Post-CAC||||0.9206
72500412|NCT03878147|144531043|SUPERIORITY|The key parameter was difference between least square means of trial arms at month 6.|Mean Difference (Final Values)|0.82|STANDARD_ERROR_OF_MEAN|0.82||0.32|TWO_SIDED|95.0|-0.8|2.44||P-value was not adjusted for multiple comparisons. A priori threshold for statistical significance was .05.|Mixed Models Analysis|Baseline value of the outcome, child's age, sex, and HIV exposure status were included as covariates.|BPG minus waitlist control.|The null hypothesis was that the means of two arms were equal. The alternative hypothesis was that means of two arms were not equal. With this sample size, differences between arms corresponding to the unadjusted effect size Cohen's d=0.33 would be detectable as statistically significant with power of .80 in two-sided tests at .05 level of significance.||2.44|-0.80|.32
72620863|NCT01887600|144772771|SUPERIORITY||Hazard Ratio (HR)|0.101|||<|0.001|TWO_SIDED|95.0|0.06|0.17|||Regression, Cox|||Hazard ratio was calculated using stratified Cox Proportional Hazards Regression stratifying on CV history and region and adjusting on Hb and eGFR at baseline as continuous covariates.||0.17|0.06|<0.001
72620864|NCT01887600|144772772|SUPERIORITY||Hazard Ratio (HR)|0.538|||=|0.045|TWO_SIDED|95.0|0.29|0.99|||Regression, Cox|||Hazard Ratio was calculated using stratified Cox Proportional Hazards Regression stratifying on CV history and region and adjusting on Hb and eGFR at baseline as continuous covariates.||0.99|0.29|=0.045
72620865|NCT01887600|144772781|SUPERIORITY||Least squares mean difference|0.374|||=|0.475|TWO_SIDED|95.0|-0.65|1.4||LSM Difference p-value is for test of differences.|Mixed Models Analysis|||The Mixed Model of Repeated Measures included treatment, visit (week 8, week 12 and week 28), visit by treatment interaction, region and history of CV disease as fixed class factors and baseline SF-36 PCS, baseline Hb, baseline eGFR as continuous covariates.||1.40|-0.65|=0.475
72458449|NCT02978183|144439131|SUPERIORITY|||||||0.9591||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: All Post-CAC Time Points||||0.9591
72458450|NCT02978183|144439131|SUPERIORITY|||||||0.5302||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: Pre-CAC||||0.5302
72458451|NCT02978183|144439131|SUPERIORITY|||||||0.7591||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 10 Minutes Post-CAC||||0.7591
72458452|NCT02978183|144439131|SUPERIORITY|||||||0.8978||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 15 Minutes Post-CAC||||0.8978
72458453|NCT02978183|144439131|SUPERIORITY|||||||0.7179||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 20 Minutes Post-CAC||||0.7179
72458454|NCT02978183|144439131|SUPERIORITY|||||||0.7262||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 25 Minutes Post-CAC||||0.7262
72458455|NCT02978183|144439131|SUPERIORITY|||||||0.8275||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 30 Minutes Post-CAC||||0.8275
72458456|NCT02978183|144439131|SUPERIORITY|||||||0.618||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: All Post-CAC Time Points||||0.6180
72458457|NCT02978183|144439132|SUPERIORITY||||||>|0.9999||||||Adjustments for multiplicity were not employed|Fisher Exact|||Day 7: 10 minutes post-CAC||||>0.9999
72458458|NCT02978183|144439132|SUPERIORITY||||||>|0.9999||||||Adjustments for multiplicity will not be employed|Fisher Exact|||Day 7: 15 minutes post-CAC||||>0.9999
72458459|NCT02978183|144439132|SUPERIORITY||||||>|0.9999||||||Adjustments for multiplicity will not be employed|Fisher Exact|||Day 7: 20 minutes post-CAC||||>0.9999
72458460|NCT02978183|144439132|SUPERIORITY|||||||0.7312||||||Adjustments for multiplicity will not be employed|Fisher Exact|||Day 7: 25 minutes post-CAC||||0.7312
72458461|NCT02978183|144439132|SUPERIORITY||||||>|0.9999||||||Adjustments for multiplicity will not be employed|Fisher Exact|||Day 7: 30 minutes post-CAC||||>0.9999
72458462|NCT02978183|144439132|SUPERIORITY||||||>|0.9999||||||Adjustments for multiplicity will not be employed|Fisher Exact|||Day 8: 10 minutes post-CAC||||>0.9999
72458463|NCT02978183|144439132|SUPERIORITY||||||>|0.9999||||||Adjustments for multiplicity will not be employed|Fisher Exact|||Day 8: 15 minutes post-CAC||||>0.9999
72458464|NCT02978183|144439132|SUPERIORITY||||||>|0.9999||||||Adjustments for multiplicity will not be employed|Fisher Exact|||Day 8: 20 minutes post-CAC||||>0.9999
72458465|NCT02978183|144439132|SUPERIORITY|||||||0.4297||||||Adjustments for multiplicity will not be employed|Fisher Exact|||Day 8: 25 minutes post-CAC||||0.4297
72458466|NCT02978183|144439132|SUPERIORITY|||||||0.4791||||||Adjustments for multiplicity will not be employed|Fisher Exact|||Day 8: 30 minutes post-CAC||||0.4791
72458467|NCT02102724|144439144|SUPERIORITY||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||The null hypotheses were that there are no differences between the two groups' change scores for any study outcomes. The power analysis was based on a study of krill oil for reducing CRP levels in persons with arthritis (N = 90) that yielded an effect size (Cohen's d) of 1.2. A sample size of 37 was determined to yield a power of 0.80 to detect an effect size of 1.0 with a two-tailed alpha of 0.05.|The change scores of the two groups (week 12 minus baseline) were compared using Wilcoxon rank sum tests.|||< 0.05
72458468|NCT02429115|144439156|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<0.05
72458469|NCT02429115|144439157|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<0.05
72458470|NCT02429115|144439158|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<0.05
72458471|NCT01450397|144439162|SUPERIORITY_OR_OTHER||||||<|0.0013|||||||t-test, 2 sided|||||||<0.0013
72620866|NCT01887600|144772782|SUPERIORITY||Least squares mean difference|1.704|||=|0.047|TWO_SIDED|95.0|0.02|3.38||LSM difference p-value is for test of differences|Mixed Models Analysis|||A Mixed Model of Repeated Measures was applied using the visits up to week 28. The model includes treatment, visit (week 8, week 12 and week 28), visit by treatment interaction, region and history of CV disease as fixed class factors and baseline FACT-An Ans, baseline Hb, baseline eGFR as continuous covariates. Baseline FACT-An Ans is defined as the FACT-An Ans value on day 1.||3.38|0.02|=0.047
72620867|NCT01887600|144772783|SUPERIORITY||Least squares mean difference|2.086|||=|0.225|TWO_SIDED|95.0|-1.29|5.46|||Mixed Models Analysis|||A Mixed Model of Repeated Measures was applied using the visits up to week 28. The results were based on the estimated difference between the two treatment arms overall mean effect during week 12 to 28 period based on this MMRM model.The model includes treatment, visit (week8, week12 and week28), visit by treatment interaction, region and history of CV disease as fixed class factors and baseline FACT-An Total Score, baseline Hb, baseline eGFR as continuous covariates.||5.46|-1.29|=0.225
72469968|NCT01080300|144463900|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-1.08|STANDARD_ERROR_OF_MEAN|0.453||0.151|TWO_SIDED|95.0|-1.98|-0.19|||Based on Van Elteren|Multiplicity addressed by requiring significance for all primary endpoints.|Based on ANCOVA|"Baseline LOCF Average Daily Frequency at Week 24:~Null hypothesis: no treatment differences relative to placebo in mean change from baseline in observed average daily number of moderate to severe hot flashes at Week 24."||-0.19|-1.98|0.1510
72469969|NCT01080300|144463901|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.22|STANDARD_ERROR_OF_MEAN|0.11||0.0004|TWO_SIDED|95.0|-0.44|0.0|||Van Elteren|Multiplicity addressed by requiring significance for all primary endpoints.|Based on ANCOVA|"Baseline LOCF Average Daily Severity Score at Week 24:~Null hypothesis: no treatment differences relative to placebo in mean change from baseline in observed average daily severity score of moderate to severe hot flashes at Week 24."||-0.00|-0.44|0.0004
72469970|NCT01080300|144463902|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|13.6||||0.0008|TWO_SIDED|95.0|5.7|21.6|||2-sample Z test|No multiplicity adjustments were made for secondary efficacy outcomes|Risk difference defined as treatment difference in proportion of responders.|"Proportion of patients who were categorized as very much or much improved in PGIC at Week 12.~Null Hypotheses: no treatment differences, relative to placebo in the proportion of patients who were categorized as very much or much improved in the PGIC score at week 12.."||21.6|5.7|0.0008
72469971|NCT01080300|144463902|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|13.4||||0.0009|TWO_SIDED|95.0|5.5|21.3|||2-sample Z test|No multiplicity adjustments were made for secondary efficacy outcomes|Risk difference defined as treatment difference in proportion of responders.|"Proportion of patients who were categorized as very much or much improved in PGIC at Week 24."||21.3|5.5|0.0009
72469972|NCT01080300|144463903|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|16.4|||<|0.0001|TWO_SIDED|95.0|8.4|24.3|||2-sample Z test|No multiplicity adjustments were made for secondary efficacy outcomes|Risk difference defined as treatment difference in proportion of responders.|"Proportion of patients who were categorized as very much or much improved in CGIC at Week 12.~Null Hypotheses: no treatment differences, relative to placebo in the proportion of patients who were categorized as very much or much improved in the CGIC score at week 12."||24.3|8.4|<0.0001
72469973|NCT01080300|144463903|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|11.0||||0.007|TWO_SIDED|95.0|3.0|19.0|||2-sample Z test|No multiplicity adjustments were made for secondary efficacy outcomes|Risk difference defined as treatment difference in proportion of responders.|Week 24||19.0|3.0|0.0070
72469974|NCT01080300|144463904|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|7.5||||0.0609|TWO_SIDED|95.0|-0.3|15.2|||two-sample Z test|No multiplicity adjustments were made for secondary efficacy outcomes|Risk difference defined as treatment difference in proportion of responders.|Week 12||15.2|-0.3|0.0609
72469975|NCT01080300|144463904|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|7.3||||0.072|TWO_SIDED|95.0|-0.7|15.3|||two-sample Z test|No multiplicity adjustments were made for secondary efficacy outcomes|Risk difference defined as treatment difference in proportion of responders.|Week 24||15.3|-0.7|0.0720
72469976|NCT01080300|144463905|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|3.8||||0.1825|TWO_SIDED|95.0|-1.8|9.4|||two-sample Z test|No multiplicity adjustments were made for secondary efficacy outcomes|Risk difference defined as treatment difference in proportion of responders.|Week 12||9.4|-1.8|0.1825
72469977|NCT01080300|144463905|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|4.4||||0.1662|TWO_SIDED|95.0|-1.8|10.7|||two-sample Z test|No multiplicity adjustments were made for secondary efficacy outcomes|Risk difference defined as treatment difference in proportion of responders.|Week 24||10.7|-1.8|0.1662
72469978|NCT01080300|144463906|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-1.36|STANDARD_ERROR_OF_MEAN|0.196|<|0.0001|TWO_SIDED|95.0|-1.75|-0.97||The P value (versus placebo) for the pairwise test of difference of the LS mean change from Baseline between the G-ER 1800-mg and placebo-treatment groups was based on the F test of type III analysis.|ANCOVA|No multiplicity adjustments were made for secondary efficacy outcomes||Change from Baseline to Week 4: LOCF daily sleep interference rating.||-0.97|-1.75|<0.0001
72469979|NCT01080300|144463906|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.92|STANDARD_ERROR_OF_MEAN|0.226|<|0.0001|TWO_SIDED|95.0|-1.36|-0.47||The P value (versus placebo) for the pairwise test of difference of the LS mean change from Baseline between the G-ER 1800-mg and placebo-treatment groups was based on the F test of type III analysis.|ANCOVA|No multiplicity adjustments were made for secondary efficacy outcomes||Change from Baseline to Week 12: LOCF daily sleep interference rating.||-0.47|-1.36|<0.0001
72469980|NCT01080300|144463906|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.95|STANDARD_ERROR_OF_MEAN|0.237|<|0.0001|TWO_SIDED|95.0|-1.42|-0.49||The P value (versus placebo) for the pairwise test of difference of the LS mean change from Baseline between the G-ER 1800-mg and placebo-treatment groups was based on the F test of type III analysis.|ANCOVA|No multiplicity adjustments were made for secondary efficacy outcomes||Change from Baseline to Week 24: LOCF daily sleep interference rating.||-0.49|-1.42|<0.0001
72469981|NCT01080300|144463907|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-2.62|STANDARD_ERROR_OF_MEAN|0.537|<|0.0001|TWO_SIDED|95.0|-3.67|-1.56||The P value (versus placebo) for the pairwise test of difference of the LS mean change from Baseline between the G-ER 1800-mg and placebo-treatment groups was based on the F test of type III analysis.|ANCOVA|No multiplicity adjustments were made for secondary efficacy outcomes||Change from Baseline to Week 4: LOCF daily insomnia severity index (ISI) rating.||-1.56|-3.67|<0.0001
72500413|NCT03878147|144531043|SUPERIORITY|The key parameter was difference between least square means of trial arms at month 2.|Mean Difference (Final Values)|-1.79|STANDARD_ERROR_OF_MEAN|0.99||0.07|TWO_SIDED|95.0|-3.74|0.16||P-value was not adjusted for multiple comparisons. A priori threshold for statistical significance was .05.|Mixed Models Analysis|Baseline value of the outcome, child's age, sex, and HIV exposure status were included as covariates.|BPG minus waitlist control.|The null hypothesis was that the means of two arms were equal. The alternative hypothesis was that means of two arms were not equal. With this sample size, differences between arms corresponding to the unadjusted effect size Cohen's d=0.33 would be detectable as statistically significant with power of .80 in two-sided tests at .05 level of significance.||0.16|-3.74|.07
72500414|NCT03878147|144531043|SUPERIORITY|The key parameter was difference between least square means of trial arms at month 6.|Mean Difference (Final Values)|-0.21|STANDARD_ERROR_OF_MEAN|0.96||0.83|TWO_SIDED|95.0|-2.1|1.68||P-value was not adjusted for multiple comparisons. A priori threshold for statistical significance was .05.|Mixed Models Analysis|Baseline value of the outcome, child's age, sex, and HIV exposure status were included as covariates.|BPG minus waitlist control.|The null hypothesis was that the means of two arms were equal. The alternative hypothesis was that means of two arms were not equal. With this sample size, differences between arms corresponding to the unadjusted effect size Cohen's d=0.33 would be detectable as statistically significant with power of .80 in two-sided tests at .05 level of significance.||1.68|-2.10|.83
72500415|NCT03878147|144531044|SUPERIORITY|The key parameter was difference between least square means of trial arms at month 2.|Mean Difference (Final Values)|-0.13|STANDARD_ERROR_OF_MEAN|0.28||0.65|TWO_SIDED|95.0|-0.71|0.42||P-value was not adjusted for multiple comparisons. A priori threshold for statistical significance was .05.|Mixed Models Analysis|Baseline value of the outcome, child's age, sex, and HIV exposure status were included as covariates.|BPG minus waitlist control.|The null hypothesis was that the means of two arms were equal. The alternative hypothesis was that means of two arms were not equal. With this sample size, differences between arms corresponding to the unadjusted effect size Cohen's d=0.33 would be detectable as statistically significant with power of .80 in two-sided tests at .05 level of significance.||0.42|-0.71|.65
72500416|NCT03878147|144531044|SUPERIORITY|The key parameter was difference between least square means of trial arms at month 6.|Median Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.29||0.95|TWO_SIDED|95.0|-0.54|0.58||P-value was not adjusted for multiple comparisons. A priori threshold for statistical significance was .05.|Mixed Models Analysis|Baseline value of the outcome, child's age, sex, and HIV exposure status were included as covariates.|BPG minus waitlist control.|The null hypothesis was that the means of two arms were equal. The alternative hypothesis was that means of two arms were not equal. With this sample size, differences between arms corresponding to the unadjusted effect size Cohen's d=0.33 would be detectable as statistically significant with power of .80 in two-sided tests at .05 level of significance.||0.58|-0.54|.95
72500417|NCT03878147|144531044|SUPERIORITY|The key parameter was difference between least square means of trial arms at month 2.|Median Difference (Final Values)|-0.39|STANDARD_ERROR_OF_MEAN|0.27||0.34|TWO_SIDED|95.0|-0.92|0.13||P-value was not adjusted for multiple comparisons. A priori threshold for statistical significance was .05.|Mixed Models Analysis|Baseline value of the outcome, child's age, sex, and HIV exposure status were included as covariates.|BPG minus waitlist control.|The null hypothesis was that the means of two arms were equal. The alternative hypothesis was that means of two arms were not equal. With this sample size, differences between arms corresponding to the unadjusted effect size Cohen's d=0.33 would be detectable as statistically significant with power of .80 in two-sided tests at .05 level of significance.||0.13|-0.92|.34
72458472|NCT00912964|144439163|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.4||||0.005|TWO_SIDED|95.0|-0.74|-0.06||The response variable for the stratified rank ANCOVA was standardized ranks on change from Baseline to Final Visit value with baseline standardized ranks and gender as covariates and geographic region as a stratum.|Stratified rank ANCOVA|LS mean difference was derived from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.||Since there were 2 coprimary efficacy endpoints and 6 key secondary efficacy endpoints, the multiplicity among the endpoints was controlled at a type I error rate at the alpha = 0.05 level using a stepwise parallel gatekeeping procedure (8 stages). In addition, since two mirabegron treatment groups were compared with placebo per endpoint, the Hochberg procedure was used to adjust for multiplicity. A stratified rank ANCOVA model was utilized for hypothesis testing.||-0.06|-0.74|0.005
72458473|NCT00912964|144439163|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.42||||0.001|TWO_SIDED|95.0|-0.76|-0.08||The response variable for the stratified rank ANCOVA was standardized ranks on change from Baseline to Final Visit value with baseline standardized ranks and gender as covariates and geographic region as a stratum.|Stratified rank ANCOVA|LS mean difference was derived from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.||Since there were 2 coprimary efficacy endpoints and 6 key secondary efficacy endpoints, the multiplicity among the endpoints was controlled at a type I error rate at the alpha = 0.05 level using a stepwise parallel gatekeeping procedure (8 stages). In addition, since two mirabegron treatment groups were compared with placebo per endpoint, the Hochberg procedure was used to adjust for multiplicity. A stratified rank ANCOVA model was utilized for hypothesis testing.||-0.08|-0.76|0.001
72500418|NCT03878147|144531044|SUPERIORITY|The key parameter was difference between least square means of trial arms at month 6.|Mean Difference (Final Values)|-0.08|STANDARD_ERROR_OF_MEAN|0.33||0.81|TWO_SIDED|95.0|-0.73|0.58||P-value was not adjusted for multiple comparisons. A priori threshold for statistical significance was .05.|Mixed Models Analysis|Baseline value of the outcome, child's age, sex, and HIV exposure status were included as covariates.|BPG minus waitlist control.|The null hypothesis was that the means of two arms were equal. The alternative hypothesis was that means of two arms were not equal. With this sample size, differences between arms corresponding to the unadjusted effect size Cohen's d=0.33 would be detectable as statistically significant with power of .80 in two-sided tests at .05 level of significance.||0.58|-0.73|.81
72504811|NCT03114969|144540516|SUPERIORITY||Odds Ratio (OR)|2.555||||0.083|TWO_SIDED|95.0|0.886|7.369||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.|||7.369|0.886|0.083
72458474|NCT00912964|144439164|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|4.6||||0.15|TWO_SIDED|95.0|-1.6|10.8||LS mean difference and p-value were derived from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|ANCOVA|||Since there were 2 coprimary efficacy endpoints and 6 key secondary efficacy endpoints, the multiplicity among the endpoints was controlled at a type I error rate at the alpha = 0.05 level using a stepwise parallel gatekeeping procedure (8 stages). In addition, since two mirabegron treatment groups were compared with placebo per endpoint, the Hochberg procedure was used to adjust for multiplicity. An ANCOVA model was used for hypothesis testing.||10.8|-1.6|0.15
72458475|NCT00912964|144439164|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|12.4|||<|0.001|TWO_SIDED|95.0|6.3|18.6||LS mean difference and p-value were derived from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|ANCOVA|||Since there were 2 coprimary efficacy endpoints and 6 key secondary efficacy endpoints, the multiplicity among the endpoints was controlled at a type I error rate at the alpha = 0.05 level using a stepwise parallel gatekeeping procedure (8 stages). In addition, since two mirabegron treatment groups were compared with placebo per endpoint, the Hochberg procedure was used to adjust for multiplicity. An ANCOVA model was used for hypothesis testing.||18.6|6.3|<0.001
72458476|NCT00912964|144439165|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.47||||0.007|TWO_SIDED|95.0|-0.82|-0.13||LS mean difference and p-value were derived from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|ANCOVA|||Since there were 2 coprimary efficacy endpoints and 6 key secondary efficacy endpoints, the multiplicity among the endpoints was controlled at a type I error rate at the alpha = 0.05 level using a stepwise parallel gatekeeping procedure (8 stages). In addition, since two mirabegron treatment groups were compared with placebo per endpoint, the Hochberg procedure was used to adjust for multiplicity. An ANCOVA model was used for hypothesis testing.||-0.13|-0.82|0.007
72458477|NCT00912964|144439165|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.42||||0.015|TWO_SIDED|95.0|-0.76|-0.08||LS mean difference and p-value were derived from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|ANCOVA|||Since there were 2 coprimary efficacy endpoints and 6 key secondary efficacy endpoints, the multiplicity among the endpoints was controlled at a type I error rate at the alpha = 0.05 level using a stepwise parallel gatekeeping procedure (8 stages). In addition, since two mirabegron treatment groups were compared with placebo per endpoint, the Hochberg procedure was used to adjust for multiplicity. An ANCOVA model was used for hypothesis testing.||-0.08|-0.76|0.015
72458478|NCT00912964|144439166|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.34||||0.039|TWO_SIDED|95.0|-0.68|-0.01||The response variable for the stratified rank ANCOVA was standardized ranks on change from Baseline to Final Visit value with baseline standardized ranks and gender as covariates and geographic region as a stratum.|Stratified rank ANCOVA|LS mean difference was derived from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.||Since there were 2 coprimary efficacy endpoints and 6 key secondary efficacy endpoints, the multiplicity among the endpoints was controlled at a type I error rate at the alpha = 0.05 level using a stepwise parallel gatekeeping procedure (8 stages). In addition, since two mirabegron treatment groups were compared with placebo per endpoint, the Hochberg procedure was used to adjust for multiplicity. A stratified rank ANCOVA model was utilized for hypothesis testing.||-0.01|-0.68|0.039
72563036|NCT00292227|144658114|SUPERIORITY_OR_OTHER||Mean Difference (Net)|7.52||||||95.0|6.31|8.72|||ANOVA|The ANOVA model included the factors treatment, period, sequence, and subject(sequence).|The direction of the estimate is Moxifloxacin - Placebo. Mean difference was estimated from the ANOVA model.|For the analysis of the assay sensitivity, an ANOVA with the factors treatment, period, sequence, and subject(sequence) for comparison of moxifloxacin vs placebo (cross-over comparison) was performed. The point estimates for the difference between placebo and positive control (moxifloxacin) and the respective 95% confidence intervals were calculated.||8.72|6.31|
72563037|NCT00292227|144658115|SUPERIORITY_OR_OTHER||Mean Difference (Net)|7.58||||||95.0|6.21|8.95|||ANOVA|The ANOVA model included the factors treatment, period, sequence, and subject(sequence).|The direction of the estimate is Moxifloxacin - Placebo. Mean difference was estimated from the ANOVA model.|For the analysis of the assay sensitivity, an ANOVA with the factors treatment, period, sequence, and subject(sequence) for comparison of moxifloxacin vs placebo (cross-over comparison) was performed. The point estimates for the difference between placebo and positive control (moxifloxacin) and the respective 95% confidence intervals were calculated.||8.95|6.21|
72563038|NCT00292227|144658116|SUPERIORITY_OR_OTHER||Mean Difference (Net)|6.19||||||95.0|4.94|7.45|||ANOVA|The ANOVA model included the factors treatment, period, sequence, and subject(sequence).|The direction of the estimate is Moxifloxacin - Placebo. Mean difference was estimated from the ANOVA model.|For the analysis of the assay sensitivity, an ANOVA with the factors treatment, period, sequence, and subject(sequence) for comparison of moxifloxacin vs placebo (cross-over comparison) was performed. The point estimates for the difference between placebo and positive control (moxifloxacin) and the respective 95% confidence intervals were calculated.||7.45|4.94|
72620868|NCT01887600|144772794|SUPERIORITY||Hazard Ratio (HR)|0.995|||=|0.973|TWO_SIDED|95.0|0.75|1.32|||Regression, Cox|||Time to doubling of serum Creatinine. Hazard ratio was calculated using stratified Cox Proportional Hazards Regression stratifying on CV history and region and adjusting on Hb and eGFR at baseline as continuous covariates.||1.32|0.75|=0.973
72620869|NCT01887600|144772795|SUPERIORITY||Hazard Ratio (HR)|0.995|||=|0.972|TWO_SIDED|95.0|0.76|1.3|||Regression, Cox|||Time to CKD progression. Hazard ratio was calculated using stratified Cox Proportional Hazards Regression stratifying on CV history and region and adjusting on Hb and eGFR at baseline as continuous covariates.||1.30|0.76|=0.972
72620870|NCT01887600|144772796|SUPERIORITY||Hazard Ratio (HR)|0.905|||=|0.439|TWO_SIDED|95.0|0.7|1.16|||Regression, Cox|||Hazard ratio was calculated using stratified Cox Proportional Hazards Regression stratifying on CV history and region and adjusting on Hb and eGFR at baseline as continuous covariates.||1.16|0.70|=0.439
72620871|NCT03688139|144772797|SUPERIORITY||difference in slopes|0.23||||0.08|TWO_SIDED||||||Mixed Models Analysis|||||||.08
72620872|NCT03688139|144772797|OTHER|This analysis tested whether the course of LPP was associated with the course of BADS over the 9-week treatment period in the Engage group.|Slope|0.03||||0.14|TWO_SIDED||||||Mixed Models Analysis|||||||.14
72620873|NCT03688139|144772798|SUPERIORITY||difference in slopes|-0.06||||0.69|TWO_SIDED||||||Mixed Models Analysis|||||||.69
72458479|NCT00912964|144439166|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.51|||<|0.001|TWO_SIDED|95.0|-0.85|-0.17||The response variable for the stratified rank ANCOVA was standardized ranks on change from Baseline to Final Visit value with baseline standardized ranks and gender as covariates and geographic region as a stratum.|Stratified rank ANCOVA|LS mean difference was derived from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.||Since there were 2 coprimary efficacy endpoints and 6 key secondary efficacy endpoints, the multiplicity among the endpoints was controlled at a type I error rate at the alpha = 0.05 level using a stepwise parallel gatekeeping procedure (8 stages). In addition, since two mirabegron treatment groups were compared with placebo per endpoint, the Hochberg procedure was used to adjust for multiplicity. A stratified rank ANCOVA model was utilized for hypothesis testing.||-0.17|-0.85|<0.001
72458480|NCT00912964|144439167|SUPERIORITY_OR_OTHER_LEGACY||LS Difference|-0.18||||0.3|TWO_SIDED|95.0|-0.53|0.16||LS mean difference and p-value were derived from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|ANCOVA|||Since there were 2 coprimary efficacy endpoints and 6 key secondary efficacy endpoints, the multiplicity among the endpoints was controlled at a type I error rate at the alpha = 0.05 level using a stepwise parallel gatekeeping procedure (8 stages). In addition, since two mirabegron treatment groups were compared with placebo per endpoint, the Hochberg procedure was used to adjust for multiplicity. An ANCOVA model was used for hypothesis testing.||0.16|-0.53|0.30
72458481|NCT00912964|144439167|SUPERIORITY_OR_OTHER_LEGACY||LS mean Difference|-0.37||||0.035|TWO_SIDED|95.0|-0.71|-0.03||LS mean difference and p-value were derived from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|ANCOVA|||Since there were 2 coprimary efficacy endpoints and 6 key secondary efficacy endpoints, the multiplicity among the endpoints was controlled at a type I error rate at the alpha = 0.05 level using a stepwise parallel gatekeeping procedure (8 stages). In addition, since two mirabegron treatment groups were compared with placebo per endpoint, the Hochberg procedure was used to adjust for multiplicity. An ANCOVA model was used for hypothesis testing.||-0.03|-0.71|0.035
72458482|NCT00912964|144439168|SUPERIORITY_OR_OTHER_LEGACY||LS mean Difference|-0.07||||0.083|TWO_SIDED|95.0|-0.15|0.01||LS mean difference and p-value were derived from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|ANCOVA|||Since there were 2 coprimary efficacy endpoints and 6 key secondary efficacy endpoints, the multiplicity among the endpoints was controlled at a type I error rate at the alpha = 0.05 level using a stepwise parallel gatekeeping procedure (8 stages). In addition, since two mirabegron treatment groups were compared with placebo per endpoint, the Hochberg procedure was used to adjust for multiplicity. An ANCOVA model was used for hypothesis testing.||0.01|-0.15|0.083
72458483|NCT00912964|144439168|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.14|||<|0.001|TWO_SIDED|95.0|-0.22|-0.06||LS mean difference and p-value were derived from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|ANCOVA|||Since there were 2 coprimary efficacy endpoints and 6 key secondary efficacy endpoints, the multiplicity among the endpoints was controlled at a type I error rate at the alpha = 0.05 level using a stepwise parallel gatekeeping procedure (8 stages). In addition, since two mirabegron treatment groups were compared with placebo per endpoint, the Hochberg procedure was used to adjust for multiplicity. An ANCOVA model was used for hypothesis testing.||-0.06|-0.22|<0.001
72458484|NCT00912964|144439169|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.36||||0.004|TWO_SIDED|95.0|-0.67|-0.05||The response variable for the stratified rank ANCOVA was standardized ranks on change from Baseline to Final Visit value with baseline standardized ranks and gender as covariates and geographic region as a stratum.|Stratified rank ANCOVA|||Since there were 2 coprimary efficacy endpoints and 6 key secondary efficacy endpoints, the multiplicity among the endpoints was controlled at a type I error rate at the alpha = 0.05 level using a stepwise parallel gatekeeping procedure (8 stages). In addition, since two mirabegron treatment groups were compared with placebo per endpoint, the Hochberg procedure was used to adjust for multiplicity. A stratified rank ANCOVA model was utilized for hypothesis testing.||-0.05|-0.67|0.004
72458485|NCT00912964|144439169|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.39||||0.002|TWO_SIDED|95.0|-0.69|-0.08||The response variable for the stratified rank ANCOVA was standardized ranks on change from Baseline to Final Visit value with baseline standardized ranks and gender as covariates and geographic region as a stratum.|Stratified rank ANCOVA|||Since there were 2 coprimary efficacy endpoints and 6 key secondary efficacy endpoints, the multiplicity among the endpoints was controlled at a type I error rate at the alpha = 0.05 level using a stepwise parallel gatekeeping procedure (8 stages). In addition, since two mirabegron treatment groups were compared with placebo per endpoint, the Hochberg procedure was used to adjust for multiplicity. A stratified rank ANCOVA model was utilized for hypothesis testing.||-0.08|-0.69|0.002
72458486|NCT00912964|144439170|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.33||||0.13|TWO_SIDED|95.0|-0.76|0.1||LS mean difference and p-value were derived from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|ANCOVA|||Since there were 2 coprimary efficacy endpoints and 6 key secondary efficacy endpoints, the multiplicity among the endpoints was controlled at a type I error rate at the alpha = 0.05 level using a stepwise parallel gatekeeping procedure (8 stages). In addition, since two mirabegron treatment groups were compared with placebo per endpoint, the Hochberg procedure was used to adjust for multiplicity. An ANCOVA model was used for hypothesis testing.||0.10|-0.76|0.13
72469982|NCT01080300|144463907|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-1.85|STANDARD_ERROR_OF_MEAN|0.543||0.0007|TWO_SIDED|95.0|-2.92|-0.78||The P value (versus placebo) for the pairwise test of difference of the LS mean change from Baseline between the G-ER 1800-mg and placebo-treatment groups was based on the F test of type III analysis.|ANCOVA|No multiplicity adjustments were made for secondary efficacy outcomes||Change from Baseline to Week 12: LOCF daily insomnia severity index (ISI) rating.||-0.78|-2.92|0.0007
72620874|NCT03688139|144772799|SUPERIORITY||difference in slopes|-0.03||||0.69|TWO_SIDED||||||Mixed Models Analysis|||||||.69
72620875|NCT03688139|144772800|SUPERIORITY||difference in slopes|-0.45||||0.39|TWO_SIDED||||||Mixed Models Analysis|||||||.39
72620876|NCT03688139|144772801|OTHER|This analysis tested the hypothesis that change in LPP for each assessment interval would predict severity of anhedonia at the next assessment in Engage but not in Supportive Therapy.|difference in slopes|-0.1||||0.58|TWO_SIDED||||||Mixed Models Analysis|||||||.58
72500419|NCT03878147|144531045|SUPERIORITY|The key parameter was difference between least square means of trial arms at month 2.|Median Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.01||0.01|TWO_SIDED|95.0|0.004|0.043||P-value was not adjusted for multiple comparisons. A priori threshold for statistical significance was .05.|Mixed Models Analysis|Baseline value of the outcome, child's age, sex, and HIV exposure status were included as covariates.|BPG minus waitlist control|The null hypothesis was that the means of two arms were equal. The alternative hypothesis was that means of two arms were not equal. With this sample size, differences between arms corresponding to the unadjusted effect size Cohen's d=0.33 would be detectable as statistically significant with power of .80 in two-sided tests at .05 level of significance.||0.043|0.004|.01
72500420|NCT03878147|144531045|SUPERIORITY|The key parameter was difference between least square means of trial arms at month 6.|Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.01||0.02|TWO_SIDED|95.0|0.003|0.04||P-value was not adjusted for multiple comparisons. A priori threshold for statistical significance was .05.|Mixed Models Analysis|Baseline value of the outcome, child's age, sex, and HIV exposure status were included as covariates.|BPG minus waitlist control|The null hypothesis was that the means of two arms were equal. The alternative hypothesis was that means of two arms were not equal. With this sample size, differences between arms corresponding to the unadjusted effect size Cohen's d=0.33 would be detectable as statistically significant with power of .80 in two-sided tests at .05 level of significance.||0.040|0.003|.02
72500421|NCT03878147|144531045|SUPERIORITY|The key parameter was difference between least square means of trial arms at month 2.|Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.01||0.19|TWO_SIDED|95.0|-0.01|0.05||P-value was not adjusted for multiple comparisons. A priori threshold for statistical significance was .05.|Mixed Models Analysis|Baseline value of the outcome, child's age, sex, and HIV exposure status were included as covariates.|BPG minus waitlist control.|The null hypothesis was that the means of two arms were equal. The alternative hypothesis was that means of two arms were not equal. With this sample size, differences between arms corresponding to the unadjusted effect size Cohen's d=0.33 would be detectable as statistically significant with power of .80 in two-sided tests at .05 level of significance.||0.05|-0.01|.19
72500422|NCT03878147|144531045|SUPERIORITY|The key parameter was difference between least square means of trial arms at month 2.|Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.01||0.19|TWO_SIDED|95.0|-0.01|0.04||P-value was not adjusted for multiple comparisons. A priori threshold for statistical significance was .05.|Mixed Models Analysis|Baseline value of the outcome, child's age, sex, and HIV exposure status were included as covariates.|BPG minus waitlist control.|The null hypothesis was that the means of two arms were equal. The alternative hypothesis was that means of two arms were not equal. With this sample size, differences between arms corresponding to the unadjusted effect size Cohen's d=0.33 would be detectable as statistically significant with power of .80 in two-sided tests at .05 level of significance.||0.04|-0.01|.19
72500423|NCT03905928|144531087|SUPERIORITY|||||||||||||||||This was a whole-brain, voxel-wise general linear model conducted in FSL software using a one-sample t-test on the tobacco\>strawberry condition contrasts conducted at the subject-level.|A whole-brain, one-sample t-test was used with a voxel threshold p \<.001 and cluster threshold p\<.05. This method results in unique p-values for each cluster identified.|||
72500424|NCT03905928|144531088|SUPERIORITY|||||||||||||||||This was a whole-brain, voxel-wise repeated measures ANOVA conducted using FSL software on activation from baseline to post-intervention that differ by the nicotine groups (18 mg/ml vs. 0 mg/ml) for the tobacco\>strawberry condition contrasts calculated at the subject-level. The means and standard deviations presented are the average post-pre scan difference scores of the BOLD percentage signal change of tobacco \> strawberry contrasts for each group.|A whole-brain, repeated measures ANOVA was used with a voxel threshold p \<.025 and cluster threshold p\<.05. This method results in unique p-values for each cluster identified.|||
72563039|NCT02093923|144658124|SUPERIORITY||Percent Change in Mean Rate|-100.0|||<|0.0001|TWO_SIDED|95.0|-100.0|-100.0|||Mixed Models Analysis|||The result was based on General Estimating Equation (GEE) analysis. Generalized Estimating Equation (GEE) approach with Poisson distribution assumption was applied to the repeated-measures mixed model with independence working correlation structure. The treatment group was a fixed effect and the number of baseline HAE attacks per week was included as a covariate in the GEE.||-100.00|-100.00|<.0001
72563040|NCT02093923|144658124|SUPERIORITY||Percent Change in Mean Rate|-87.77||||0.005|TWO_SIDED|95.0|-97.18|-46.9|||Mixed Models Analysis|||The result was based on General Estimating Equation (GEE) analysis. Generalized Estimating Equation (GEE) approach with Poisson distribution assumption was applied to the repeated-measures mixed model with independence working correlation structure. The treatment group was a fixed effect and the number of baseline HAE attacks per week was included as a covariate in the GEE.||-46.90|-97.18|0.0050
72563041|NCT02093923|144658124|SUPERIORITY||Percent Change in Mean Rate|-91.08||||0.0012||95.0|-97.93|-61.57|||Mixed Models Analysis|||The result was based on General Estimating Equation (GEE) analysis. Generalized Estimating Equation (GEE) approach with Poisson distribution assumption was applied to the repeated-measures mixed model with independence working correlation structure. The treatment group was a fixed effect and the number of baseline HAE attacks per week was included as a covariate in the GEE.||-61.57|-97.93|0.0012
72563042|NCT02093923|144658125|SUPERIORITY||Percent Change in Mean Rate|-100.0|||<|0.0001|TWO_SIDED|95.0|-100.0|-100.0|||Mixed Models Analysis|||The result was based on General Estimating Equation (GEE) analysis. Generalized Estimating Equation (GEE) approach with Poisson distribution assumption was applied to the repeated-measures mixed model with independence working correlation structure. The treatment group was a fixed effect and the number of baseline HAE attacks per week was included as a covariate in the GEE.||-100.00|-100.00|<.0001
72370491|NCT00488683|144251632|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.35||||0.1||95.0|||||Non-parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Spearman correlation coefficient between memory B cells one month after primary vaccination and hSBA titers one month after booster vaccination for the serogroup W-135||||0.10
72563043|NCT02093923|144658125|SUPERIORITY||Percent Change in Mean Rate|-84.08|||<|0.0001|TWO_SIDED|95.0|-93.07|-63.46|||Mixed Models Analysis|||The result was based on General Estimating Equation (GEE) analysis. Generalized Estimating Equation (GEE) approach with Poisson distribution assumption was applied to the repeated-measures mixed model with independence working correlation structure. The treatment group was a fixed effect and the number of baseline HAE attacks per week was included as a covariate in the GEE.||-63.46|-93.07|<.0001
72500425|NCT03905928|144531089|SUPERIORITY|||||||||||||||||This was a whole-brain, voxel-wise repeated measures ANOVA conducted using FSL software on activation from baseline to post-intervention between the flavor groups (tobacco vs. strawberry) for the tobacco\>strawberry condition contrasts calculated at the subject-level. The means and standard deviations presented are the average post-pre scan difference scores of the BOLD percentage signal change of tobacco \> strawberry contrasts for each group.|A whole-brain, repeated measures ANOVA was used with a voxel threshold p \<.025 and cluster threshold p\<.05. This method results in unique p-values for each cluster identified.|||
72500426|NCT03905928|144531090|SUPERIORITY|||||||0.573|||||||ANOVA|||We conducted a one-way ANOVA to compare the change in e-cigarette dependence (week 4 - week 2 PSECDI difference score) between the four e-cigarette groups.||||0.573
72500427|NCT03905928|144531092|SUPERIORITY|||||||0.022|||||||ANOVA|||We conducted a one-way ANOVA to compare changes in self-reported craving across all groups.||||.022
72500428|NCT02700451|144531137|EQUIVALENCE|Two-sided 95% confidence interval|||||<|0.001||||||Threshold for statistical significance was p = 0.05|Kruskal-Wallis|||The distribution of OME total in the first 72H is the same across these arms||||<0.001
72500429|NCT02700451|144531137|EQUIVALENCE|Two-sided 95% confidence interval|||||<|0.001||||||The thresholds for statistical significant was p = 0.05|Kruskal-Wallis|||The distribution of OME total to discharge is the same across these arms||||<0.001
72620877|NCT03688139|144772801|OTHER|This analysis tested the hypothesis that change in SHAPS for each assessment interval would predict severity of anhedonia at the next assessment in Engage but not in Supportive Therapy.|difference in slopes|0.0||||0.96|TWO_SIDED||||||Mixed Models Analysis|||||||.96
72620878|NCT02470377|144772802|SUPERIORITY|The hypothesis was that either Target 1 (Occipital) or Target 2 (Vermis) would be more effective than the control target (Cerebellar hemisphere) but that there may be baseline differences in participants who chose Target 1 vs Target 2.||||||0.0439||||||Only p-values \<0.05 were considered significant|ANOVA|One way ANOVA, immediate DHI changes used for calculation.||This was an N-of-1 pilot study in which all participants received one session of each of 3 targets and chose which of the 3 led to the most acute reduction in intensity of rocking. The participants were treated with the target that they chose and then completed post stimulation diaries.||||0.0439
72620879|NCT02470377|144772803|SUPERIORITY|The hypothesis was that either Target 1 (Occipital) or Target 2 (Vermis) would be more effective than the control target (Cerebellar hemisphere) but that there may be baseline differences in participants who chose Target 1 vs Target 2.||||||0.0316|||||||ANOVA|One way ANOVA, immediate MBRS changes used for calculation.||This was an N-of-1 pilot study in which all participants received one session of each of 3 targets and chose which of the 3 led to the most acute reduction in intensity of rocking. The participants were treated with the target that they chose and then completed post stimulation diaries.||||0.0316
72500430|NCT02700451|144531138|EQUIVALENCE|Two-sided||||||0.048|||||||Chi-squared|||Similar Distribution of opioid use between the 3 arms||||0.048
72500431|NCT02700451|144531139|EQUIVALENCE|Two-sided||||||0.595|||||||Chi-squared|||||||0.595
72500432|NCT02700451|144531142|EQUIVALENCE|Two-sided 95% confidence interval||||||0.732|||||||Kruskal-Wallis|||The distribution of POD1 - Current pain level is the same across the 3 arms||||0.732
72500433|NCT02700451|144531142|EQUIVALENCE|Two-sided 95% confidence interval||||||0.896|||||||Kruskal-Wallis|||The distribution of POD1 - Best pain level is the same across the 3 arms||||0.896
72500434|NCT02700451|144531142|EQUIVALENCE|Two-sided 95% confidence interval||||||0.004|||||||Kruskal-Wallis|||The distribution of POD1 - Worst pain level is the same across the 3 arms||||0.004
72500435|NCT02700451|144531142|EQUIVALENCE|Two-sided 95% confidence interval||||||0.325|||||||Kruskal-Wallis|||The distribution of POD3 - Current pain level is the same across the 3 arms||||0.325
72500436|NCT02700451|144531142|EQUIVALENCE|Two-sided 95% confidence interval||||||0.283|||||||Kruskal-Wallis|||The distribution of POD3 - Best pain level is the same across the 3 arms||||0.283
72500437|NCT02700451|144531142|EQUIVALENCE|Two-sided 95% confidence interval||||||0.61|||||||Kruskal-Wallis|||The distribution of POD3 - Worst pain level is the same across the 3 arms||||0.610
72500438|NCT02700451|144531143|EQUIVALENCE|Two-sided 95% confidence interval||||||0.016|||||||Kruskal-Wallis|||The distribution of POD1 - Pain has interfered with General Activity is the same across the 3 arms||||0.016
72500439|NCT02700451|144531143|EQUIVALENCE|Two-sided 95% confidence interval||||||0.294|||||||Kruskal-Wallis|||The distribution of POD1 - Pain has interfered with Mood is the same across the 3 arms||||0.294
72500440|NCT02700451|144531143|EQUIVALENCE|Two-sided 95% confidence interval||||||0.016|||||||Kruskal-Wallis|||The distribution of POD1 - Pain has interfered with Walking Ability is the same across the 3 arms||||0.016
72500441|NCT02700451|144531143|EQUIVALENCE|Two-sided 95% confidence interval||||||0.082|||||||Kruskal-Wallis|||The distribution of POD1 - Pain has interfered with Normal work is the same across the 3 arms||||0.082
72500442|NCT02700451|144531143|EQUIVALENCE|Two-sided 95% confidence interval||||||0.117|||||||Kruskal-Wallis|||The distribution of POD1 - Pain has interfered with Relation with other is the same across the 3 arms||||0.117
72500443|NCT02700451|144531143|EQUIVALENCE|Two-sided 95% confidence interval||||||0.061|||||||Fisher Exact|||The distribution of POD1 - Pain has interfered with Sleep is the same across the 3 arms||||0.061
72500444|NCT02700451|144531143|EQUIVALENCE|Two-sided 95% confidence interval||||||0.023|||||||Kruskal-Wallis|||The distribution of POD1 - Pain has interfered with Enjoyment of life is the same across the 3 arms||||0.023
72500445|NCT02700451|144531143|EQUIVALENCE|Two-sided 95% confidence interval||||||0.681|||||||Kruskal-Wallis|||The distribution of POD3 - Pain has interfered with General Activity is the same across the 3 arms||||0.681
72500446|NCT02700451|144531143|EQUIVALENCE|Two-sided 95% confidence interval||||||0.405|||||||Kruskal-Wallis|||The distribution of POD3 - Pain has interfered with Mood is the same across the 3 arms||||0.405
72500447|NCT02700451|144531143|EQUIVALENCE|Two-sided 95% confidence interval||||||0.458|||||||Kruskal-Wallis|||The distribution of POD3 - Pain has interfered with Walking Ability is the same across the 3 arms||||0.458
72500448|NCT02700451|144531143|EQUIVALENCE|Two-sided 95% confidence interval||||||0.482|||||||Kruskal-Wallis|||The distribution of POD3 - Pain has interfered with Normal work is the same across the 3 arms||||0.482
72500449|NCT02700451|144531143|EQUIVALENCE|Two-sided 95% confidence interval||||||0.544|||||||Kruskal-Wallis|||The distribution of POD3 - Pain has interfered with Relation with other is the same across the 3 arms||||0.544
72500450|NCT02700451|144531143|EQUIVALENCE|Two-sided 95% confidence interval||||||0.202|||||||Kruskal-Wallis|||The distribution of POD3 - Pain has interfered with Sleep is the same across the 3 arms||||0.202
72500451|NCT02700451|144531143|EQUIVALENCE|Two-sided 95% confidence interval||||||0.58|||||||Kruskal-Wallis|||The distribution of POD3 - Pain has interfered with Enjoyment of life is the same across the 3 arms||||0.580
72500452|NCT02700451|144531145|EQUIVALENCE|Two-sided 95% confidence interval||||||0.928|||||||Kruskal-Wallis|||The distribution of Total Drain output at 24H is the same across the 3 arms||||0.928
72500453|NCT02700451|144531145|EQUIVALENCE|Two-sided 95% confidence interval||||||0.906|||||||Kruskal-Wallis|||The distribution of Total Drain output at 48H is the same across the 3 arms||||0.906
72500454|NCT02700451|144531145|EQUIVALENCE|Two-sided 95% confidence interval||||||0.926|||||||Kruskal-Wallis|||The distribution of Total Drain output at 72H is the same across the 3 arms||||0.926
72500455|NCT02700451|144531145|EQUIVALENCE|Two-sided 95% confidence interval||||||0.934|||||||Kruskal-Wallis|||The distribution of Total Drain output at Discharge is the same across the 3 arms||||0.934
72500456|NCT02700451|144531146|EQUIVALENCE|Two-sided||||||0.078|||||||Chi-squared|||Proportion of patient receiving at least 1 transfusion is the same across the 3 arms||||0.078
72500457|NCT02700451|144531147|EQUIVALENCE|Two-sided 95% confidence interval||||||792|||||||Chi-squared|||||||0792
72500458|NCT02700451|144531148|EQUIVALENCE|Two-sided 95% confidence interval||||||0.034|||||||Kruskal-Wallis|||The distribution of Length of stay in day is the same across these arms||||0.034
72500459|NCT02700451|144531148|EQUIVALENCE|Two-sided 95% confidence interval||||||0.03|||||||Kruskal-Wallis|||The distribution of Length of stay in hour is the same across these arms||||0.030
72500460|NCT02700451|144531149|EQUIVALENCE|Two-sided 95% confidence interval||||||0.974|||||||ANOVA|||Comparison of the PCS score between the 3 arms||||0.974
72500461|NCT02700451|144531149|EQUIVALENCE|Two-sided 95% confidence interval||||||0.444|||||||ANOVA|||Comparison of the MCS between the 3 ams||||0.444
72500462|NCT02700451|144531150|EQUIVALENCE|Two-sided 95% confidence interval||||||0.215|||||||ANOVA|||||||0.215
72500463|NCT02700451|144531151|EQUIVALENCE|Two-sided 95% confidence interval||||||0.044|||||||ANOVA|||Comparison PCS score between the 3 arms||||0.044
72500464|NCT02700451|144531151|EQUIVALENCE|Two-sided 95% confidence interval||||||0.767|||||||ANOVA|||Comparison MCS score between the 3 arms||||0.767
72500465|NCT02700451|144531152|EQUIVALENCE|Two-sided 95% confidence interval||||||0.191|||||||ANOVA|||||||0.191
72500466|NCT04373460|144531162|SUPERIORITY||Risk Difference (RD)|3.4||||0.005|TWO_SIDED|95.0|1.0|5.8|||Fisher Exact|||||5.8|1.0|0.005
72500467|NCT04373460|144531163|SUPERIORITY||Risk Difference (RD)|-0.05||||0.16|TWO_SIDED|95.0|-0.11|0.02|||Rate per person-years|||||0.02|-0.11|0.16
72500468|NCT04373460|144531164|SUPERIORITY||Incidence rate difference|0.18||||0.02|TWO_SIDED|95.0|0.03|0.32|||Rate per person-years|||||0.32|0.03|0.02
72500469|NCT04373460|144531165|SUPERIORITY||Risk Difference (RD)|0.01||||0.32|TWO_SIDED|95.0|-0.01|0.02|||Rate per person-years|||||0.02|-0.01|0.32
72500470|NCT04373460|144531170|SUPERIORITY|||||||0.65|||||||Fisher Exact|||||||0.65
72500471|NCT04373460|144531174|SUPERIORITY||Risk Ratio (RR)|0.525|||||TWO_SIDED|95.0|0.192|1.425||||||||1.425|0.192|
72500472|NCT02115308|144531220|SUPERIORITY|||||||0.001|||||||paired, t-test|non-adjusted||REST-TO-REGADENOSON STRESS||||0.001
72500473|NCT02115308|144531220|SUPERIORITY|||||||0.017||||||non-adjusted|paired, t-test|||REST-TO-REGADENOSON STRESS||||0.017
72500474|NCT02115308|144531220|SUPERIORITY|||||||0.495||||||non-adjusted|paired, t-test|||REST-TO-REGADENOSON STRESS||||0.495
72370492|NCT00488683|144251632|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.35||||0.56||95.0|||||Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccination and hSBA titers one month after booster vaccination for the serogroup Y||||0.56
72500475|NCT02115308|144531220|SUPERIORITY|||||||0.365|||||||t-test, 2 sided|non-adjusted||REST||||0.365
72500476|NCT02115308|144531220|SUPERIORITY|||||||0.602|||||||t-test, 2 sided|non adjusted||REST||||0.602
72500477|NCT02115308|144531220|SUPERIORITY|||||||0.915|||||||t-test, 2 sided|non adjusted||REST||||0.915
72500478|NCT02115308|144531220|SUPERIORITY|||||||0.033|||||||t-test, 2 sided|non adjusted||Regadenoson STRESS||||0.033
72500479|NCT02115308|144531220|SUPERIORITY|||||||0.002|||||||t-test, 2 sided|non adjusted||Regadenoson STRESS||||0.002
72500480|NCT02115308|144531220|SUPERIORITY|||||||0.087|||||||t-test, 2 sided|non adjusted||Regadenoson STRESS||||0.087
72500481|NCT02115308|144531220|SUPERIORITY|||||||0.399|||||||t-test, 2 sided|non adjusted||REST-TO-STRESS CHANGE||||0.399
72500482|NCT02115308|144531220|SUPERIORITY|||||||0.03|||||||t-test, 2 sided|non adjusted||REST-TO-STRESS Change||||0.030
72500483|NCT02115308|144531220|SUPERIORITY|||||||0.048|||||||t-test, 2 sided|non adjusted||REST-TO-STRESS Change||||0.048
72500484|NCT02115308|144531221|SUPERIORITY|||||||0.011||||||Non-adjusted.|paired, t-test|||Rest VS Regadenoson Stress||||0.011
72500485|NCT02115308|144531221|SUPERIORITY|||||||0.003||||||non-adjusted|paired t-test|||Rest VS Regadenoson Stress||||0.003
72500486|NCT02115308|144531221|SUPERIORITY|non-adjusted||||||0.39|||||||paired, t-test|||Rest VS Regadenoson Stress||||0.390
72500487|NCT02115308|144531221|SUPERIORITY|non-adjusted|||||<|0|||||||t-test, 2 sided|||REST||||<0.000
72500488|NCT02115308|144531221|SUPERIORITY|non-adjusted|||||<|0|||||||t-test, 2 sided|||REST||||<0.000
72500489|NCT02115308|144531221|SUPERIORITY|non-adjusted||||||0.022|||||||t-test, 2 sided|||REST||||0.022
72500490|NCT02115308|144531221|SUPERIORITY|||||||0.001||||||non-adjusted|t-test, 2 sided|||Regadenoson STRESS||||0.001
72500491|NCT02115308|144531221|SUPERIORITY||||||<|0||||||non-adjusted|t-test, 2 sided|||Regadenoson STRESS||||<0.000
72500492|NCT02115308|144531221|SUPERIORITY|||||||0.006||||||non-adjusted|t-test, 2 sided|||Regadenoson STRESS||||0.006
72500493|NCT02115308|144531221|SUPERIORITY||||||<|0|||||||t-test, 2 sided|non-adjusted||REST-TO-STRESS Change||||<0.000
72500494|NCT02115308|144531221|SUPERIORITY|||||||0.058|||||||t-test, 2 sided|non-adjusted||REST-TO-STRESS Changes||||0.058
72500495|NCT02115308|144531221|SUPERIORITY|||||||0.31|||||||t-test, 2 sided|non-adjusted||REST-TO-STRESS Change||||0.310
72500496|NCT02115308|144531222|SUPERIORITY|||||||0.001|||||||paired, t-test|non adjusted||REST vs STRESS||||0.001
72500497|NCT02115308|144531222|SUPERIORITY|||||||0.002|||||||paired, t-test|non adjusted||REST vs STRESS||||0.002
72500498|NCT02115308|144531222|SUPERIORITY|||||||0.721|||||||paired, t-test|non adjusted||REST vs STRESS||||0.721
72500499|NCT02115308|144531222|SUPERIORITY|||||||0.797|||||||t-test, 2 sided|non adjusted||REST||||0.797
72500500|NCT02115308|144531222|SUPERIORITY|||||||0.474|||||||t-test, 2 sided|non adjusted||REST||||0.474
72458487|NCT00912964|144439170|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.59||||0.007|TWO_SIDED|95.0|-1.01|-0.16||LS mean difference and p-value were derived from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|ANCOVA|||Since there were 2 coprimary efficacy endpoints and 6 key secondary efficacy endpoints, the multiplicity among the endpoints was controlled at a type I error rate at the alpha = 0.05 level using a stepwise parallel gatekeeping procedure (8 stages). In addition, since two mirabegron treatment groups were compared with placebo per endpoint, the Hochberg procedure was used to adjust for multiplicity. An ANCOVA model was used for hypothesis testing.||-0.16|-1.01|0.007
72458488|NCT02978716|144439202|SUPERIORITY||Mean difference|0.3|STANDARD_ERROR_OF_MEAN|0.58||0.7048|TWO_SIDED|95.0|-0.8|1.5||A Hochberg-based gatekeeping procedure was used to control the global family-wise error rate across the multiple null hypotheses in the strong sense at a 1-sided 0.025 level.|Analysis of covariance (ANCOVA)|||Duration of SN in Cycle 1 in Group 3 vs Group 1.||1.5|-0.8|0.7048
72458489|NCT02978716|144439202|SUPERIORITY||Mean difference|0.8|STANDARD_ERROR_OF_MEAN|0.71||0.3364|TWO_SIDED|95.0|-0.6|2.3||2-sided p-value was calculated using a ANCOVA with study baseline ANC value as covariate, stratification factors of lines of systemic therapy, liver involvement and treatment as fixed effects.|ANCOVA|||Duration of SN in Cycle 1 in Group 2 vs Group 1.||2.3|-0.6|0.3364
72458490|NCT02978716|144439203|SUPERIORITY||Adjusted rate ratio|0.776|STANDARD_ERROR_OF_MEAN|0.2762||0.7048|TWO_SIDED|95.0|0.386|1.559||A 1-sided p-value was calculated using Hochberg-based gatekeeping procedure to control the global familywise error rate across the multiple null hypotheses.|Modified Poisson method|||Number of participants with SN in Group 3 vs Group 1.||1.559|0.386|0.7048
72458491|NCT02978716|144439203|SUPERIORITY||Adjusted rate ratio|0.961|STANDARD_ERROR_OF_MEAN|0.364||0.9154|TWO_SIDED|95.0|0.457|2.019||The p-value was calculated using modified Poisson method adjusting for number of cycles, accounting for the number of prior lines of therapy (0 versus 1 - 2) and liver involvement as the stratification factors and baseline ANC as a covariate.|Modified Poisson Regression|||Number of participants with SN in Group 2 vs Group 1.||2.019|0.457|0.9154
72458492|NCT02978716|144439206|SUPERIORITY||Adjusted hazard ratio (HR)|0.4|STANDARD_ERROR_OF_MEAN|0.125||0.0004|TWO_SIDED|95.0|0.22|0.74||P-value was calculated using the stratified log-rank test to account for the number of prior lines of therapy (0 versus 1 - 2) and liver involvement as the stratification factors.|stratified log-rank test||Cox regression model.|Overall survival in Group 3 vs Group 1.||0.74|0.22|0.0004
72458493|NCT02978716|144439206|SUPERIORITY||Adjusted HR|0.31|STANDARD_ERROR_OF_MEAN|0.111||0.0016|TWO_SIDED|95.0|0.15|0.63||P-value was calculated using the stratified log-rank test to account for the number of prior lines of therapy (0 versus 1 - 2) and liver involvement as the stratification factors.|stratified log-rank test||Cox regression model.|Overall survival in Group 2 vs Group 1.||0.63|0.15|0.0016
72458494|NCT02978716|144439226|SUPERIORITY||Adjusted HR|0.493|STANDARD_ERROR_OF_MEAN|0.1957||0.7048|TWO_SIDED|95.0|0.226|1.073||A 1-sided p-value was calculated using Hochberg-based gatekeeping procedure to control the global familywise error rate across the multiple null hypotheses.|modified Poisson regression|||RBC Transfusions in Group 3 vs Group 1.||1.073|0.226|0.7048
72458495|NCT02978716|144439226|SUPERIORITY||Adjusted rate ratio|0.885|STANDARD_ERROR_OF_MEAN|0.3089||0.7272|TWO_SIDED|95.0|0.447|1.754||P-value was calculated using modified Poisson method adjusting for duration of treatment in days accounting for number of prior lines of therapy (0 versus 1 - 2); liver involvement as the stratification factors and baseline hemoglobin as a covariate.|Modified Poisson Regression|||RBC Transfusions in Group 2 vs Group 1.||1.754|0.447|0.7272
72458496|NCT02978716|144439227|SUPERIORITY||Adjusted rate ratio|0.988|STANDARD_ERROR_OF_MEAN|0.6105||0.7048|TWO_SIDED|95.0|0.294|3.317||A 1-sided p-value was calculated using Hochberg-based gatekeeping procedure to control the global familywise error rate across the multiple null hypotheses.|modified Poisson regression|||Platelet Transfusions in Group 3 vs Group 1.||3.317|0.294|0.7048
72458497|NCT02978716|144439227|SUPERIORITY||Adjusted rate ratio|0.527|STANDARD_ERROR_OF_MEAN|0.4077||0.4078|TWO_SIDED|95.0|0.116|2.399||P-value: calculated using modified Poisson method adjusting for duration of treatment in days accounting for number of prior lines of therapy (0 versus 1 - 2); liver involvement as stratification factors and baseline platelet count as a covariate.|Modified Poisson Regression|||Platelet Transfusions in Group 2 vs Group 1.||2.399|0.116|0.4078
72458498|NCT02978716|144439228|SUPERIORITY||Adjusted rate ratio|0.645|STANDARD_ERROR_OF_MEAN|0.1902||0.7048|TWO_SIDED|95.0|0.362|1.15||A 1-sided p-value was calculated using Hochberg-based gatekeeping procedure to control the global familywise error rate across the multiple null hypotheses.|modified Poisson regression|||G-CSF Administration in Group 3 vs Group 1.||1.150|0.362|0.7048
72458499|NCT02978716|144439228|SUPERIORITY||Adjusted rate ratio|0.936|STANDARD_ERROR_OF_MEAN|0.226||0.7835|TWO_SIDED|95.0|0.583|1.502||P-value was calculated using modified Poisson method adjusting for number of cycles, accounting for the number of prior lines of therapy (0 versus 1 - 2) and liver involvement as the stratification factors and baseline ANC as a covariate.|Modified Poisson Regression|||G-CSF Administration in Group 2 vs Group 1.||1.502|0.583|0.7835
72458500|NCT02978716|144439231|SUPERIORITY||Adjusted rate ratio|0.991|STANDARD_ERROR_OF_MEAN|0.3718||0.7048|TWO_SIDED|95.0|0.475|2.067||The 1-sided p-value was calculated using Hochberg-based gatekeeping procedure to control the global family wise error rate across the multiple null hypotheses.|negative binomial regression|||All-cause Dose Reductions in Group 3 vs Group 1.||2.067|0.475|0.7048
72458501|NCT02978716|144439231|SUPERIORITY||Adjusted rate ratio|0.82|STANDARD_ERROR_OF_MEAN|0.2744||0.5541|TWO_SIDED|95.0|0.426|1.58||P-value was calculated using negative binomial method adjusting for number of cycles, accounting for the number of prior lines of therapy (0 versus 1 - 2) and liver involvement as the stratification factors.|negative binomial regression|||All-cause Dose Reductions in Group 2 vs Group 1.||1.580|0.426|0.5541
72458502|NCT01974102|144439237|SUPERIORITY||||||<|0.015|||||||t-test, 2 sided|||||||<0.015
72458503|NCT01974102|144439238|SUPERIORITY||||||<|0.03|||||||t-test, 2 sided|||||||<0.03
72458504|NCT02470806|144439248|NON_INFERIORITY|Stepwise regression method - Primary efficacy analysis, difference between treatment groups in percentage change in wound area from baseline visit to end of 12-week treatment period for the PP population.||||||0.001|TWO_SIDED|95.0|||||Stepwise regression|||Percentage change in wound area from Baseline to end of 12-week treatment period (PP population - all wounds)||||0.001
72500501|NCT02115308|144531222|SUPERIORITY|||||||0.537|||||||t-test, 2 sided|non adjusted||||||0.537
72500502|NCT02115308|144531222|SUPERIORITY|||||||0.717|||||||t-test, 2 sided|non adjusted||Regadenoson STRESS||||0.717
72458505|NCT01094106|144439264|SUPERIORITY|||||||0.1|||||||t-test, 2 sided|||In a previous non-randomised study at our institution, the mean oxycodone consumption in the control group was 60.7 mg (SD, 22.2 mg) during the first 48 h after caesarean section. At α = 0.05, 31 patients would be needed in each group to achieve a power of 90% for detecting a 30% reduction in the need for rescue opioids, which we considered a clinically meaningful effect. We decided to enrol 70 patients. The final study population was 67 patients.||||0.10
72458506|NCT01094106|144439265|SUPERIORITY|||||||0.08||||||No adjustments for multiple comparisons|Wilcoxon (Mann-Whitney)|||Highest recorded pain scores at rest, 0-6 h||||0.08
72458507|NCT01094106|144439265|SUPERIORITY|||||||0.86||||||No adjustments for multiple comparisons|Wilcoxon (Mann-Whitney)|||Highest recorded pain scores at rest, 6-12 h||||0.86
72458508|NCT01094106|144439265|SUPERIORITY|||||||0.66||||||No adjustments for multiple comparisons|Wilcoxon (Mann-Whitney)|||Highest recorded pain scores at rest, 12-24 h||||0.66
72458509|NCT01094106|144439265|SUPERIORITY|||||||0.79||||||No adjustments for multiple comparisons|Wilcoxon (Mann-Whitney)|||Highest recorded pain scores at rest, 24-36 h||||0.79
72458510|NCT01094106|144439265|SUPERIORITY|||||||0.2||||||No adjustments for multiple comparisons|Wilcoxon (Mann-Whitney)|||Highest recorded pain scores at rest, 36-48 h||||0.20
72458511|NCT01094106|144439265|SUPERIORITY|||||||0.36||||||No adjustments for multiple comparisons|Wilcoxon (Mann-Whitney)|||Highest recorded pain scores when moving, 0-6 h||||0.36
72458512|NCT01094106|144439265|SUPERIORITY|||||||0.43||||||No adjustments for multiple comparisons|Wilcoxon (Mann-Whitney)|||Highest recorded pain scores when moving, 6-12 h||||0.43
72458513|NCT01094106|144439265|SUPERIORITY|||||||0.68||||||No adjustments for multiple comparisons|Wilcoxon (Mann-Whitney)|||Highest recorded pain scores when moving, 12-24 h||||0.68
72458514|NCT01094106|144439265|SUPERIORITY|||||||0.37||||||No adjustments for multiple comparisons|Wilcoxon (Mann-Whitney)|||Highest recorded pain scores when moving, 24-36 h||||0.37
72458515|NCT01094106|144439265|SUPERIORITY|||||||0.06||||||No adjustments for multiple comparisons|Wilcoxon (Mann-Whitney)|||Highest recorded pain scores when moving, 36-48 h||||0.06
72563044|NCT02093923|144658125|SUPERIORITY||Percent Change in Mean Rate|-87.84|||<|0.0001|TWO_SIDED|95.0|-94.81|-71.5|||Mixed Models Analysis|||The result was based on General Estimating Equation (GEE) analysis. Generalized Estimating Equation (GEE) approach with Poisson distribution assumption was applied to the repeated-measures mixed model with independence working correlation structure. The treatment group was a fixed effect and the number of baseline HAE attacks per week was included as a covariate in the GEE.||-71.50|-94.81|<.0001
72458516|NCT01094106|144439266|SUPERIORITY|||||||0.3|||||||Chi-squared|||||||0.30
72458517|NCT01294644|144439267|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.6|||<|0.001|TWO_SIDED|95.0|1.52|4.43|||Regression, Logistic|Logistic regression analysis with treatment and Baseline CR-SMFRS value in the model.|The odds ratio was based on a logistic regression model adjusted for the Baseline score. Odds ratios \>1 indicate a positive treatment effect.|"The null hypothesis was there was no difference between deoxycholic acid 1 mg/cm² and placebo.~An adjustment for multiplicity was performed for the two co-primary endpoints. This was accounted for by using the larger of the two P-values in the Bonferroni-Holm scheme."||4.43|1.52|<0.001
72458518|NCT01294644|144439267|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.13|||<|0.001|TWO_SIDED|95.0|1.83|5.36|||Regression, Logistic|Logistic regression analysis with treatment and Baseline CR-SMFRS value in the model.|The odds ratio was based on a logistic regression model adjusted for the Baseline score. Odds ratios \>1 indicate a positive treatment effect.|"The null hypothesis was there was no difference between deoxycholic acid 2 mg/cm² and placebo.~An adjustment for multiplicity was performed for the two co-primary endpoints. This was accounted for by using the larger of the two P-values in the Bonferroni-Holm scheme."||5.36|1.83|<0.001
72458519|NCT01294644|144439268|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|11.71||||0.02|TWO_SIDED|95.0|1.48|92.67|||Regression, Logistic|Logistic regression analysis with treatment and Baseline CR-SMFRS value in the model.|Odds ratio was based on a logistic regression model adjusted for the Baseline score. Odds ratios \>1 indicate a positive treatment effect.|||92.67|1.48|0.020
72458520|NCT01294644|144439268|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|11.53||||0.021|TWO_SIDED|95.0|1.46|91.24|||Regression, Logistic|Logistic regression analysis with treatment and Baseline CR-SMFRS value in the model.|Odds ratio was based on a logistic regression model adjusted for the Baseline score. Odds ratios \>1 indicate a positive treatment effect.|||91.24|1.46|0.021
72458521|NCT01294644|144439269|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.37|||<|0.001|TWO_SIDED|95.0|3.06|9.44|||Regression, Logistic|Logistic regression analysis with treatment and Baseline SSRS value in the model.|Odds ratio was based on a logistic regression model adjusted for Baseline score. Odds ratios \>1 indicate a positive treatment effect.|"The null hypothesis was there was no difference between deoxycholic acid 1 mg/cm² and placebo.~An adjustment for multiplicity was performed for the two co-primary endpoints. This was accounted for by using the larger of the two P-values in the Bonferroni-Holm scheme."||9.44|3.06|<0.001
72469983|NCT01080300|144463907|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-1.76|STANDARD_ERROR_OF_MEAN|0.548||0.0014|TWO_SIDED|95.0|-2.84|-0.69|||ANCOVA|No multiplicity adjustments were made for secondary efficacy outcomes||Change from Baseline to Week 24: LOCF daily insomnia severity index (ISI) rating.||-0.69|-2.84|0.0014
72469984|NCT01080300|144463908|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.21|STANDARD_ERROR_OF_MEAN|0.084||0.0137|TWO_SIDED|95.0|-0.37|-0.04||The p-value (vs. Placebo) for the test of difference of the LS mean change from baseline between Gabapentin ER 1800mg and placebo group is based on the F-test of Type III analysis.|ANCOVA|No multiplicity adjustments were made for secondary efficacy outcomes||MENQOL score at Week 4||-0.04|-0.37|0.0137
72469985|NCT01080300|144463908|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.14|STANDARD_ERROR_OF_MEAN|0.084||0.0872|TWO_SIDED|95.0|-0.31|0.02||The p-value (vs. Placebo) for the test of difference of the LS mean change from baseline between Gabapentin ER 1800mg and placebo group is based on the F-test of Type III analysis.|ANCOVA|No multiplicity adjustments were made for secondary efficacy outcomes||MENQOL score at Week 12||0.02|-0.31|0.0872
72469986|NCT01080300|144463908|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.05|STANDARD_ERROR_OF_MEAN|0.091||0.5607|TWO_SIDED|95.0|-0.23|0.13||The p-value (vs. Placebo) for the test of difference of the LS mean change from baseline between Gabapentin ER 1800mg and placebo group is based on the F-test of Type III analysis.|ANCOVA|No multiplicity adjustments were made for secondary efficacy outcomes||MENQOL score at Week 24||0.13|-0.23|0.5607
72458522|NCT01294644|144439269|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.62|||<|0.001|TWO_SIDED|95.0|2.65|8.04|||Regression, Logistic|Logistic regression analysis with treatment and Baseline SSRS value in the model|Odds ratio was based on a logistic regression model adjusted for Baseline score. Odds ratios \>1 indicate a positive treatment effect.|"The null hypothesis was there was no difference between deoxycholic acid 2 mg/cm² and placebo.~An adjustment for multiplicity was performed for the two co-primary endpoints. This was accounted for by using the larger of the two P-values in the Bonferroni-Holm scheme."||8.04|2.65|<0.001
72458523|NCT01294644|144439270|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.35|||<|0.001|TWO_SIDED|95.0|-0.51|-0.19|||Mixed Models Repeated Measures|The model included the fixed effect factors visit and treatment, the visit\*treatment interaction, and the Baseline CR-SMFRS values as covariate.||||-0.19|-0.51|<0.001
72458524|NCT01294644|144439270|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4|||<|0.001|TWO_SIDED|95.0|-0.56|-0.24|||Mixed Models Repeated Measures|The model included the fixed effect factors visit and treatment, the visit\*treatment interaction, and the baseline CR-SMFRS values as covariate.||||-0.24|-0.56|<0.001
72458525|NCT01294644|144439271|SUPERIORITY_OR_OTHER||LS Mean Difference|1.36|||<|0.001|TWO_SIDED|95.0|0.97|1.75|||ANCOVA|The model includes the fixed effect factor treatment and the Baseline values as covariate.||||1.75|0.97|<0.001
72458526|NCT01294644|144439271|SUPERIORITY_OR_OTHER||LS Mean Difference|1.26|||<|0.001|TWO_SIDED|95.0|0.87|1.65|||ANCOVA|The model includes the fixed effect factor treatment and the Baseline values as covariate.||||1.65|0.87|<0.001
72500503|NCT02115308|144531222|SUPERIORITY|||||||0.041|||||||t-test, 2 sided|non adjusted||Regadenoson STRESS||||0.041
72500504|NCT02115308|144531222|SUPERIORITY|||||||0.05|||||||t-test, 2 sided|non adjusted||Regadenoson STRESS||||0.050
72500505|NCT02115308|144531222|SUPERIORITY|||||||0.908||||||non adjusted|t-test, 2 sided|||REST-to-STRESS Change||||0.908
72500506|NCT02115308|144531222|SUPERIORITY|||||||0.233|||||||t-test, 2 sided|non adjusted||||||0.233
72500507|NCT02115308|144531222|SUPERIORITY|||||||0.187|||||||t-test, 2 sided|non adjusted||REST-to-STRESS Change||||0.187
72500508|NCT02115308|144531224|SUPERIORITY|||||||0.008|||||||paired, t-test|non adjusted||REST vs STRESS||||0.008
72458527|NCT01294644|144439272|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.8||||0.09|TWO_SIDED|95.0|-1.72|0.13|||Mixed Models Repeated Measures|The model includes the fixed effect factors visit and treatment, the visit\*treatment interaction, and the Baseline values as covariate.||||0.13|-1.72|0.090
72458528|NCT01294644|144439272|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.97||||0.04|TWO_SIDED|95.0|-1.89|-0.05|||Mixed Models Repeated Measures|The model includes the fixed effect factors visit and treatment, the visit\*treatment interaction, and the Baseline values as covariate.||||-0.05|-1.89|0.040
72458529|NCT01294644|144439273|SUPERIORITY_OR_OTHER|||||||0.009|TWO_SIDED||||||Pearson's chi-square test|||||||0.009
72500509|NCT02115308|144531224|SUPERIORITY|||||||0.006|||||||paired, t-test|non adjusted||REST vs STRESS||||0.006
72500510|NCT02115308|144531224|SUPERIORITY|||||||0.428|||||||paired, t-test|non adjusted||REST vs STRESS||||0.428
72500511|NCT02115308|144531224|SUPERIORITY||||||<|0|||||||t-test, 2 sided|non adjusted||REST||||<0.000
72500512|NCT02115308|144531224|SUPERIORITY||||||<|0|||||||t-test, 2 sided|non adjusted||REST||||<0.000
72370493|NCT00488683|144251632|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|-0.07||||0.84||95.0|||||Non-parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Spearman correlation coefficient between memory B cells one month after primary vaccination and hSBA titers one month after booster vaccination for the serogroup Y||||0.84
72458530|NCT01294644|144439273|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED||||||Pearson's chi-square test|||||||0.001
72500513|NCT02115308|144531224|SUPERIORITY|||||||0.006|||||||t-test, 2 sided|non adjusted||REST||||0.006
72500514|NCT02115308|144531224|SUPERIORITY|||||||0.002|||||||t-test, 2 sided|non adjusted||Regadenoson STRESS||||0.002
72458531|NCT02548585|144439290|SUPERIORITY||||||<|0.0001|||||||ANCOVA|p-value was based on pairwise comparison using analysis of covariance (ANCOVA) adjusted by baseline value.||||||< 0.0001
72458532|NCT02548585|144439291|SUPERIORITY|||||||0.0008|||||||ANCOVA|p-value was based on pairwise comparison using ANCOVA adjusted by baseline value.||||||0.0008
72458533|NCT01782209|144439316|OTHER||Incidence|17.3|||||TWO_SIDED|95.0|13.4|21.8|||||95% Clopper-Pearson Confidence Interval|||21.8|13.4|
72500515|NCT02115308|144531224|SUPERIORITY||||||<|0|||||||t-test, 2 sided|non adjusted||Regadenoson STRESS||||<0.000
72500516|NCT02115308|144531224|SUPERIORITY|||||||0.004|||||||t-test, 2 sided|non adjusted||Regadenoson STRESS||||0.004
72500517|NCT02115308|144531224|SUPERIORITY||||||<|0|||||||t-test, 2 sided|non adjusted||REST-to-STRESS Change||||<0.000
72500518|NCT02115308|144531224|SUPERIORITY|||||||0.172|||||||t-test, 2 sided|non adjusted||REST-to-STRESS Change||||0.172
72500519|NCT02115308|144531224|SUPERIORITY|||||||0.957|||||||t-test, 2 sided|non adjusted||REST-to-STRESS Change||||0.957
72500520|NCT00642642|144531225|SUPERIORITY_OR_OTHER|||||||0.0109||95.0||||a priori threshold for statistical significance was 0.05|McNemar|Paired test of proportions||"Null hypothesis: no difference in the response rates between the two treatment arms.~Statistical test: McNemar's paired test of proportions Significance level: two sided alpha of 0.05 for each of the two co-primary endpoints.~Assumptions for power calculations:~Response rate for azficel-T treated cheek = 40% Response rate for placebo treated cheek = 20% 10% dropout rate; dropouts counted as failures. Low correlation between cheeks \& 50% correlation between endpoints"||||0.0109
72500521|NCT00642642|144531226|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||a priori threshold for statistical significance = 0.05|McNemar|paired test of proportions||"Null hypothesis: no difference in the response rates between the two treatment arms.~Statistical test: McNemar's paired test of proportions Significance level: two sided alpha of 0.05 for each of the two co-primary endpoints.~Assumptions for power calculations:~Response rate for azficel-T treated cheek = 40% Response rate for placebo treated cheek = 20% 10% dropout rate; dropouts counted as failures. Low correlation between cheeks \& 50% correlation between endpoints"||||<0.0001
72500522|NCT00332202|144531264|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.92||||0.541|TWO_SIDED|95.0|0.689|1.216|||Log Rank|||||1.216|0.689|0.541
72500523|NCT00332202|144531270|SUPERIORITY_OR_OTHER|||||||0.606|TWO_SIDED||||||Mixed Models Analysis|||Analysis for Month 2||||0.606
72500524|NCT00332202|144531270|SUPERIORITY_OR_OTHER|||||||0.971|TWO_SIDED||||||Mixed Models Analysis|||Analysis for Month 4||||0.971
72500525|NCT00332202|144531270|SUPERIORITY_OR_OTHER|||||||0.58|TWO_SIDED||||||Mixed Models Analysis|||Analysis for Month 6||||0.580
72458534|NCT02033174|144439325|SUPERIORITY_OR_OTHER|||||||0.05|TWO_SIDED|95.0|||||Kruskal-Wallis|||||||0.05
72458535|NCT03242863|144439326|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||||||<0.0001
72458536|NCT03242863|144439327|SUPERIORITY|||||||0.0015|||||||Mixed Models Analysis|||||||0.0015
72458537|NCT03242863|144439328|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||||||<0.0001
72458538|NCT03242863|144439329|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||||||<0.0001
72458539|NCT04620733|144439331|SUPERIORITY||Risk Difference (RD)|41.7|||<|0.0001|TWO_SIDED|95.0|27.7|53.4||Two-sided p-value for pair-wise comparison was based on the CMH test adjusted for both randomization stratification variables (baseline ALP level: \< 350 U/L and ≥ 350 U/L; baseline Pruritus NRS: \< 4 and ≥ 4).|Cochran-Mantel-Haenszel|||||53.4|27.7|< 0.0001
72458540|NCT04620733|144439334|SUPERIORITY||Risk Difference (RD)|25.0|||<|0.0001|TWO_SIDED|95.0|18.3|33.2|||Cochran-Mantel-Haenszel||Two-sided p-value for pair-wise comparison is based on the Cochran Mantel Haenszel test adjusted for both stratification variables (baseline ALP level: \< 350 U/L and \>= 350 U/L; baseline pruritus NRS: \< 4 and \>= 4).|||33.2|18.3|< 0.0001
72458541|NCT04620733|144439335|SUPERIORITY||Least Squares (LS) Mean Difference|-1.5||||0.0047|TWO_SIDED|95.0|-2.5|-0.5|||MMRM|Mixed-Effect Model Repeated Measure (MMRM)||||-0.5|-2.5|0.0047
72458542|NCT02489799|144439342|EQUIVALENCE|The study was powered based on two former studies utilizing RIAS, (both powered =.8 and alpha =.05). With a 0.6 effect size, the required sample size is 72 patients (36 per group) for a one-tailed test of study hypotheses (power =.8 and alpha =.05).|Incidence Rate Ratio|1.06||||0.545|TWO_SIDED|95.0|0.87|1.3|||Poisson model using GEE|We fit a Poisson model using generalized estimating equations. No adjustments were made for degrees of freedom.|The incidence rate ratio compares intervention to control.|We employed two ways of interpreting this data. The first treats the outcome continuously, which is described in the results section. Here we describe the outcome treating it as a ratio. We created a variable representing the numerator of the ratio (type 1) and the denominator of the ratio (type 2) thereby treating the information in both the numerator and denominator as random (each a Poisson variable).||1.30|0.87|0.545
72500526|NCT00332202|144531270|SUPERIORITY_OR_OTHER|||||||0.265|TWO_SIDED||||||Mixed Models Analysis|||Analysis for Month 12||||0.265
72500527|NCT00332202|144531270|SUPERIORITY_OR_OTHER|||||||0.46|TWO_SIDED||||||Mixed Models Analysis|||Analysis for Month 18||||0.460
72500528|NCT00332202|144531270|SUPERIORITY_OR_OTHER|||||||0.441|TWO_SIDED||||||Mixed Models Analysis|||Analysis for Month 24||||0.441
72500529|NCT00332202|144531270|SUPERIORITY_OR_OTHER|||||||0.357|TWO_SIDED||||||Mixed Models Analysis|||Analysis for Month 36||||0.357
72500530|NCT00332202|144531271|SUPERIORITY_OR_OTHER|||||||0.267|TWO_SIDED||||||Mixed Models Analysis|||Analysis for Month 6||||0.267
72458543|NCT01241448|144439352|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.29||||0.094|TWO_SIDED|90.0|-0.58|-0.01||No multiplicity adjustments were used to calculate the p-value.|Mixed Models Analysis|||Sixty-five randomized patients (45 completers) per arm were expected to provide at least 90% power to detect 0.8% HbA1c difference with placebo assuming a SD for change in HbA1c of 1.2% (0.05 1-sided type I error).||-0.01|-0.58|0.094
72458544|NCT01241448|144439352|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.62|||<|0.001|TWO_SIDED|90.0|-0.9|-0.34||No multiplicity adjustments were used to calculate the p-value.|Mixed Models Analysis|||Sixty-five randomized patients (45 completers) per arm were expected to provide at least 90% power to detect 0.8% HbA1c difference with placebo assuming a SD for change in HbA1c of 1.2% (0.05 1-sided type I error).||-0.34|-0.90|<0.001
72458545|NCT01241448|144439352|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.77|||<|0.01|TWO_SIDED|90.0|-1.05|-0.48||No multiplicity adjustments were used to calculate the p-value.|Mixed Models Analysis|||Sixty-five randomized patients (45 completers) per arm were expected to provide at least 90% power to detect 0.8% HbA1c difference with placebo assuming a SD for change in HbA1c of 1.2% (0.05 1-sided type I error).||-0.48|-1.05|<0.01
72458546|NCT03740737|144439400|OTHER||Treatment difference|63.0|||<|0.001|TWO_SIDED|95.0|55.5|67.1|||Fisher Exact||95% exact Agresti-Min confidence intervals.|||67.1|55.5|<0.001
72458547|NCT03740737|144439401|OTHER||Treatment difference|29.5|||<|0.001|TWO_SIDED|95.0|22.5|33.7|||Fisher Exact||95% exact Agresti-Min confidence intervals.|Ongoing Pregnancy Rate in the Fresh Cycle||33.7|22.5|<0.001
72458548|NCT03740737|144439405|OTHER||Treatment difference|31.8|||<|0.001|TWO_SIDED|95.0|24.7|36.0|||Fisher Exact||95% exact Agresti-Min confidence intervals.|Clinical pregnancy rate in the fresh cycle||36.0|24.7|<0.001
72458549|NCT03740737|144439405|OTHER||Treatment difference|68.2|||<|0.001|TWO_SIDED|95.0|61.2|72.1|||Fisher Exact||95% exact Agresti-Min confidence intervals.|Clinical pregnancy rate cumulatively||72.1|61.2|<0.001
72458550|NCT03740737|144439406|OTHER||Treatment difference|30.5|||<|0.001|TWO_SIDED|95.0|23.4|34.6|||Fisher Exact||95% exact Agresti-Min confidence intervals.|Vital pregnancy rate in the fresh cycle||34.6|23.4|<0.001
72500531|NCT00332202|144531271|SUPERIORITY_OR_OTHER|||||||0.807|TWO_SIDED||||||Mixed Models Analysis|||Analysis for Month 24||||0.807
72500532|NCT00332202|144531271|SUPERIORITY_OR_OTHER|||||||0.864|TWO_SIDED||||||Mixed Models Analysis|||Analysis for Month 33||||0.864
72500533|NCT00332202|144531272|SUPERIORITY||Hazard Ratio (HR)|0.768||||0.4|TWO_SIDED|95.0|0.415|1.42|||Regression, Cox|||||1.420|0.415|0.400
72500534|NCT00332202|144531272|SUPERIORITY||Hazard Ratio (HR)|1.309||||0.539|TWO_SIDED|95.0|0.557|3.08|||Regression, Cox|||||3.080|0.557|0.539
72500535|NCT00332202|144531273|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.775||||0.084|TWO_SIDED|95.0|0.947|3.329|||Regression, Cox|||||3.329|0.947|0.084
72500536|NCT00332202|144531273|SUPERIORITY||Hazard Ratio (HR)|1.286||||0.585|TWO_SIDED|95.0|0.527|3.137|||Regression, Cox|||||3.137|0.527|0.585
72500537|NCT03871491|144531275|SUPERIORITY||Risk Ratio (RR)|0.67|||<|0.001|TWO_SIDED|95.0|0.56|0.79||We calculated P values to test each of the primary hypotheses at an alpha level of 0.05 overall, with a nominal alpha level of 0.0001 at the interim analysis.|Regression, Logistic|Used multiple imputation for missing outcomes by means of logistic regression imputation.||The null hypothesis is there is no treatment effect on the incidence of maternal death or sepsis within 6 weeks (42 days) post-delivery||0.79|0.56|<0.001
72458551|NCT03740737|144439406|OTHER||Treatment difference|65.1|||<|0.001|TWO_SIDED|95.0|57.5|69.1|||Fisher Exact||95% exact Agresti-Min confidence intervals.|Vital pregnancy rate cumulatively||69.1|57.5|<0.001
72458552|NCT03740737|144439408|OTHER||Treatment difference|35.0|||<|0.001|TWO_SIDED|95.0|28.1|39.2|||Fisher Exact||95% exact Agresti-Min confidence intervals.|Positive βhCG rate in the fresh cycle||39.2|28.1|<0.001
72458553|NCT03740737|144439408|OTHER||Treatment difference|72.4|||<|0.001|TWO_SIDED|95.0|65.3|76.2|||Fisher Exact||95% exact Agresti-Min confidence intervals.|Positive βhCG rate cumulatively||76.2|65.3|<0.001
72458554|NCT03740737|144439420|OTHER||||||<|0.001|||||||Wilcoxon rank sum test|||||||<0.001
72458555|NCT03740737|144439421|OTHER||||||<|0.001|||||||Wilcoxon rank sum test|||||||<0.001
72458556|NCT03740737|144439422|OTHER|||||||0.22|||||||Fisher Exact|||||||0.220
72458557|NCT03740737|144439423|OTHER|||||||0.588|||||||Fisher Exact|||||||0.588
72458558|NCT01286311|144439470|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.0||||0.99|TWO_SIDED|95.0|0.54|1.86|||Generalized Logistic Regression|||||1.86|0.54|0.99
72458559|NCT01286311|144439471|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.25||||0.27|TWO_SIDED|95.0|0.84|1.85|||Generalized Logistic Regression|||||1.85|0.84|0.27
72458560|NCT01286311|144439472|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.13||||0.038|TWO_SIDED|95.0|1.05|4.32|||Generalized Logistic Regression|||||4.32|1.05|0.038
72458561|NCT01286311|144439473|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.72||||0.13|TWO_SIDED|95.0|0.73|10.1|||Generalized Logistic Regression|||||10.1|0.73|0.13
72458562|NCT01286311|144439474|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.18||||0.3|TWO_SIDED|95.0|0.5|9.5|||Generalized Logistic Regression|||||9.5|0.50|0.30
72458563|NCT03034863|144439475|SUPERIORITY||Slope|-0.37|STANDARD_ERROR_OF_MEAN|0.17||0.03|TWO_SIDED|||||All p-values are two-tailed|Hierarchical Linear Modeling/MLM|Hypothesis tested using a dummy code representing group assignment (1=SAFER; 0=I-SPI) in the Level 2 equation for the slope term.|Slope represents relative unit change/month between both conditions. Positive slope terms represent relative increases in SAFER compared to I-SPI. Negative slope terms represent relative reductions in SAFER compared to I-SPI.|||||.03
72458564|NCT03034863|144439476|SUPERIORITY||Slope|-0.02|STANDARD_ERROR_OF_MEAN|0.05||0.69|TWO_SIDED||||||Hierarchical Linear Modeling/MLM|Hypothesis tested using a dummy code representing group assignment (1=SAFER; 0=I-SPI) in the Level 2 equation for the slope term.|Slope represents relative unit change/month between both conditions. Positive slope terms represent relative increases in SAFER compared to I-SPI. Negative slope terms represent relative reductions in SAFER compared to I-SPI.|||||.69
72620880|NCT02470377|144772804|SUPERIORITY|The hypothesis was that either Target 1 (Occipital) or Target 2 (Vermis) would be more effective than the control target (Cerebellar hemisphere) but that there may be baseline differences in participants who chose Target 1 vs Target 2.||||||0.1754|||||||ANOVA|One way ANOVA, immediate HADS changes used for calculation.||This was an N-of-1 pilot study in which all participants received one session of each of 3 targets and chose which of the 3 led to the most acute reduction in intensity of rocking. The participants were treated with the target that they chose and then completed post stimulation diaries.||||0.1754
72458565|NCT03034863|144439477|SUPERIORITY|||||||0.49||||||All p-values are two-tailed|Fisher Exact|Compares veterans who reported 1+ attempts at any follow-up wave out of total number of veterans in each group (i.e., 0/19 for SAFER; 2/20 for I-SPI).||||||.49
72458566|NCT03034863|144439478|SUPERIORITY||Slope|0.08|STANDARD_ERROR_OF_MEAN|0.04||0.03|TWO_SIDED||||||Hierarchical Linear Modeling/MLM|Hypothesis tested using a dummy code representing group assignment (1=SAFER; 0=I-SPI) in the Level 2 equation for the slope term.|Slope represents relative unit change/month between both conditions. Positive slope terms represent relative increases in SAFER compared to I-SPI. Negative slope terms represent relative reductions in SAFER compared to I-SPI.|||||.03
72458567|NCT03034863|144439479|SUPERIORITY||Slope|0.01|STANDARD_ERROR_OF_MEAN|0.07||0.87|TWO_SIDED||||||Hierarchical Linear Modeling/MLM|Hypothesis tested using a dummy code representing group assignment (1=SAFER; 0=I-SPI) in the Level 2 equation for the slope term.|Slope represents relative unit change/month between both conditions. Positive slope terms represent relative increases in SAFER compared to I-SPI. Negative slope terms represent relative reductions in SAFER compared to I-SPI.|||||.87
72458568|NCT03034863|144439480|SUPERIORITY||Slope|0.17|STANDARD_ERROR_OF_MEAN|0.08||0.03|TWO_SIDED||||||Hierarchical Linear Modeling/MLM|Hypothesis tested using a dummy code representing group assignment (1=SAFER; 0=I-SPI) in the Level 2 equation for the slope term.|Slope represents relative unit change/month between both conditions. Positive slope terms represent relative increases in SAFER compared to I-SPI. Negative slope terms represent relative reductions in SAFER compared to I-SPI.|||||.03
72458569|NCT03034863|144439481|SUPERIORITY||Slope|-0.12|STANDARD_ERROR_OF_MEAN|0.08||0.16|TWO_SIDED||||||Hierarchical Linear Modeling/MLM|Hypothesis tested using a dummy code representing group assignment (1=SAFER; 0=I-SPI) in the Level 2 equation for the slope term.|Slope represents relative unit change/month between both conditions. Positive slope terms represent relative increases in SAFER compared to I-SPI. Negative slope terms represent relative reductions in SAFER compared to I-SPI.|||||.16
72458570|NCT03034863|144439482|SUPERIORITY||Slope|0.09|STANDARD_ERROR_OF_MEAN|0.35||0.81|TWO_SIDED|||||All p-values are two-tailed|Hierarchical Linear Modeling/MLM|Hypothesis tested using a dummy code representing group assignment (1=SAFER; 0=I-SPI) in the Level 2 equation for the slope term.|Slope represents relative unit change/month between both conditions. Positive slope terms represent relative increases in SAFER compared to I-SPI. Negative slope terms represent relative reductions in SAFER compared to I-SPI.|||||.81
72458571|NCT03034863|144439483|SUPERIORITY||Slope|-0.37|STANDARD_ERROR_OF_MEAN|0.62||0.55|TWO_SIDED|||||All p-values are two-tailed|Hierarchical Linear Modeling/MLM|Hypothesis tested using a dummy code representing group assignment (1=SAFER; 0=I-SPI) in the Level 2 equation for the slope term.|Slope represents relative unit change/month between both conditions. Positive slope terms represent relative increases in SAFER compared to I-SPI. Negative slope terms represent relative reductions in SAFER compared to I-SPI.|||||.55
72458572|NCT03034863|144439484|SUPERIORITY||Slope|0.02|STANDARD_ERROR_OF_MEAN|0.05||0.64|TWO_SIDED|||||All p-values are two-tailed|Hierarchical Linear Modeling/MLM|Hypothesis tested using a dummy code representing group assignment (1=SAFER; 0=I-SPI) in the Level 2 equation for the slope term.|Slope represents relative unit change/month between both conditions. Positive slope terms represent relative increases in SAFER compared to I-SPI. Negative slope terms represent relative reductions in SAFER compared to I-SPI.|||||.64
72563045|NCT02093923|144658126|SUPERIORITY||Percent Change in Mean Rate|-100.0|||<|0.0001|TWO_SIDED|95.0|-100.0|-100.0|||Mixed Models Analysis|||The result was based on General Estimating Equation (GEE) analysis. Generalized Estimating Equation (GEE) approach with Poisson distribution assumption was applied to the repeated-measures mixed model with independence working correlation structure. The treatment group was a fixed effect and the number of baseline HAE attacks per week was included as a covariate in the GEE.||-100.00|-100.00|<.0001
72458573|NCT03034863|144439485|SUPERIORITY||Slope|-0.02|STANDARD_ERROR_OF_MEAN|0.04||0.62|TWO_SIDED|||||All p-values are two-tailed|Hierarchical Linear Modeling/MLM|Hypothesis tested using a dummy code representing group assignment (1=SAFER; 0=I-SPI) in the Level 2 equation for the slope term.|Slope represents relative unit change/month between both conditions. Positive slope terms represent relative increases in SAFER compared to I-SPI. Negative slope terms represent relative reductions in SAFER compared to I-SPI.|||||.62
72469987|NCT00825305|144463951|NON_INFERIORITY_OR_EQUIVALENCE|The null hypothesis states that the Zagreb schedule is inferior to the Essen schedule in terms of day 14 antibody titers assuming no difference between the two schedules and the equivalence limit of 1.5 titer levels (log2).|ratio of log2 mean|-0.2|||||TWO_SIDED|95.0|-0.81|0.4|||ANOVA||Ratio of log2 mean (Zagreb/Essen) on day 14|||0.4|-0.81|
72370494|NCT00488683|144251632|SUPERIORITY_OR_OTHER||R-square|0.59||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and hSBA titers one month after booster vaccination for the serogroup A||||
72469988|NCT00825305|144463952|NON_INFERIORITY_OR_EQUIVALENCE|The null hypothesis states that the Zagreb schedule is inferior to the Essen schedule in terms of day 7 antibody titers assuming no difference between the two schedules and the equivalence limit of 1.5 titer levels (log2).|ratio of log2 mean (day7)|-0.21|||||TWO_SIDED|95.0|-0.77|0.35|||ANOVA||Ratio of log2 means (Zagreb/Essen) on day 7|||0.35|-0.77|
72469989|NCT00825305|144463952|NON_INFERIORITY_OR_EQUIVALENCE|The null hypothesis states that the Zagreb schedule is inferior to the Essen schedule in terms of day 42 antibody titers assuming no difference between the two schedules and the equivalence limit of 1.5 titer levels (log2).|ratio of log2 mean (day 42)|-0.07|||||TWO_SIDED|95.0|-0.72|0.58|||ANOVA||Ratio of log2 mean (Zagreb/(Essen) on day 42|||0.58|-0.72|
72469990|NCT03617289|144463960|SUPERIORITY|||||||0.771||||||Threshold for statistical significance set at p\<0.05|Wilcoxon (Mann-Whitney)|||||||0.771
72469991|NCT03617289|144463961|SUPERIORITY||||||<|0.046||||||Threshold for statistical significance was set at p\<0.05|Chi-squared|||||||<0.046
72469992|NCT00762476|144463966|SUPERIORITY_OR_OTHER||||||>|0.5|TWO_SIDED|95.0|||||Poisson regression|||||||>0.5000
72469993|NCT00762476|144463967|SUPERIORITY_OR_OTHER||||||>|0.5|TWO_SIDED|95.0|||||Poisson regression|||||||>0.5000
72469994|NCT00762476|144463968|SUPERIORITY_OR_OTHER|||||||0.3451|TWO_SIDED|95.0|||||Poisson regression|||||||0.3451
72469995|NCT01637077|144464024|SUPERIORITY|||||||0.56|||||||Kruskal-Wallis|||||||0.56
72469996|NCT01637077|144464025|SUPERIORITY|||||||0.48|||||||Kruskal-Wallis|||||||0.48
72469997|NCT01637077|144464026|SUPERIORITY|||||||0.62|||||||Kruskal-Wallis|||Worst pain over the past 24 hours||||0.62
72469998|NCT01637077|144464026|SUPERIORITY|||||||0.22|||||||Kruskal-Wallis|||Average pain over the past 24 hours||||0.22
72469999|NCT01637077|144464026|SUPERIORITY|||||||0.07|||||||Kruskal-Wallis|||Least pain over the past 24 hours||||0.07
72470000|NCT01637077|144464028|SUPERIORITY|||||||0.87|||||||Chi-squared|||||||0.87
72470001|NCT01637077|144464029|SUPERIORITY|||||||0.84|||||||Chi-squared|||||||0.84
72470002|NCT01637077|144464030|SUPERIORITY|||||||0.03|||||||Chi-squared|||||||0.03
72470003|NCT01637077|144464031|SUPERIORITY|||||||0.12|||||||Kruskal-Wallis|||||||0.12
72470004|NCT01637077|144464032|SUPERIORITY|||||||0.78|||||||Chi-squared|||||||0.78
72470005|NCT01637077|144464033|SUPERIORITY|||||||0.16|||||||Chi-squared|||||||0.16
72470006|NCT01637077|144464034|SUPERIORITY|||||||0.46|||||||Kruskal-Wallis|||Sensory neuropathy||||0.46
72470007|NCT01637077|144464034|SUPERIORITY|||||||0.86|||||||Kruskal-Wallis|||Autonomic neuropathy||||0.86
72470008|NCT01637077|144464034|SUPERIORITY|||||||0.4|||||||Kruskal-Wallis|||Motor neuropathy||||0.40
72470009|NCT02559310|144464055|NON_INFERIORITY|Non-inferiority Margin = 12.5%.|Treatment Difference (Lef - Mox)|-2.9|||||TWO_SIDED|95.0|-8.5|2.8|||||Difference in percentage of Responders for ECR (Lefamulin - Moxifloxacin). CI computed using continuity-corrected Z-statistic.|||2.8|-8.5|
72470010|NCT02559310|144464056|NON_INFERIORITY|Non-inferiority Margin = 10%.|Treatment Difference (Lef - Mox)|-2.6|||||TWO_SIDED|95.0|-8.9|3.9|||||Difference in Percentage of Success for IACR at test of cure visit (Lefamulin - Moxifloxacin). CI computed via Miettinen-Nurminen method, adjusted for prior antibiotic use \[Y vs. N\] and PORT risk class \[III vs. IV/V\], using CMH stratum weights.|||3.9|-8.9|
72470011|NCT02559310|144464056|NON_INFERIORITY|Non-Inferiority Margin = 10%|Treatment Difference (Lef - Mox)|-2.6|||||TWO_SIDED|95.0|-9.2|4.1|||||Difference in percentage of Success for IACR at test of cure visit. CI computed using continuity-corrected Z-statistic.|||4.1|-9.2|
72470012|NCT02559310|144464057|NON_INFERIORITY|Non-Inferiority Margin = 10%.|Treatment Difference|-2.5|||||TWO_SIDED|95.0|-8.4|3.4|||||Difference in percentage of success for IACR at test of cure visit (Lefamulin - Moxifloxacin). CI computed via Miettinen-Nurminen method, adjusted for prior antibiotic use \[Y vs. N\] and PORT risk class \[III vs. IV/V\], using CMH stratum weights.|||3.4|-8.4|
72470013|NCT02559310|144464057|NON_INFERIORITY|Non-Inferiority Margin = 10%|Treatment Difference (Lef - Mox)|-2.5|||||TWO_SIDED|95.0|-8.7|3.7|||||Difference in Percentage of Success for IACR at test of cure visit (Lefamulin - Moxifloxacin). CI computed using continuity-corrected Z-statistic|||3.7|-8.7|
72470014|NCT03732677|144464072|SUPERIORITY||Odds Ratio (OR)|1.6||||0.0005|TWO_SIDED|95.0|1.227|2.084|||Regression, Logistic|Strata adjusted odds ratio by the logistic regression method adjusting for stratification factors: renal function , tumor stage and PDL1 status .||||2.084|1.227|0.0005
72470015|NCT03732677|144464073|SUPERIORITY||Hazard Ratio (HR)|0.68|||<|0.0001|TWO_SIDED|95.877|0.554|824.0||Stratified by renal function(adequate vs borderline),tumor stage(T2N0 vs \>T2N0), PDL1 status(high vs low/negative)|Log Rank||The HR and CI were estimated from a stratified Cox proportional hazard model adjusting for renal function (adequate vs borderline), tumor stage (T2N0 vs \>T2N0) and PDL1 status (high vs low/negative)||95% CI for hazard ratio: 0.558 - 0.817|0824|0.554|<0.0001
72458574|NCT03034863|144439486|SUPERIORITY||Slope|0.04|STANDARD_ERROR_OF_MEAN|0.03||0.16|TWO_SIDED|||||All p-values are two-tailed|Hierarchical Linear Modeling/MLM|Hypothesis tested using a dummy code representing group assignment (1=SAFER; 0=I-SPI) in the Level 2 equation for the slope term.|Slope represents relative unit change/month between both conditions. Positive slope terms represent relative increases in SAFER compared to I-SPI. Negative slope terms represent relative reductions in SAFER compared to I-SPI.|||||.16
72458575|NCT01416285|144439527|SUPERIORITY|||||||0.004|||||||Kaplan-Meier and COX regression|Univariate and multi-variable||All-cause death||||0.004
72458576|NCT01416285|144439527|SUPERIORITY|||||||0.003|||||||Kaplan-Meier and COX regression|Univariate and multi-variable||Heart failure-related re-hospitalizations||||0.003
72458577|NCT01416285|144439527|SUPERIORITY||||||<|0.001|||||||Kaplan-Meier and COX regression|Univariate and multi-variable||a composite outcome of both death and heart failure-related re-hospitalizations||||<0.001
72458578|NCT02410278|144439567|SUPERIORITY||Odds Ratio (OR)|3.931||||0.0617|TWO_SIDED|95.0|0.938|20.832|||weighted logistic regression model|||Odds ratio is the odds of an event in the Montelukast treatment group divided by the odds of an event in the placebo treatment group. P-value is from the likelihood ratio test that the odds ratio is 1. CI = profile likelihood confidence interval.||20.832|0.938|0.0617
72458579|NCT02410278|144439568|SUPERIORITY||adjusted mean difference|0.084||||0.3753|TWO_SIDED|95.0|-0.104|0.273|||ANCOVA|||Results are obtained from an ANCOVA model for comparing average change of the GSRS score in the two treatment groups, adjusted for age, weight and baseline GSRS score. Weights, defined as the proportions of days with GSRS score recorded during the Day 1 - Day 10 period are applied to adjust for missing data.||0.273|-0.104|0.3753
72458580|NCT02410278|144439569|SUPERIORITY||adjusted mean difference|0.081||||0.0376|TWO_SIDED|95.0|0.005|0.158|||Repeated measures model|||Results are obtained from a repeated measures model for change from baseline (Day 0) in the GSRS score. The model includes treatment, day and treatment by day interaction, adjusted for age, weight and baseline GSRS score, and has spatial-exponential variance-covariance structure. The P-value is for testing the null hypothesis of no difference between the two treatment groups in the average change from baseline (Day 0) between Day 1 and Week 10.||0.158|0.005|0.0376
72458581|NCT02410278|144439570|SUPERIORITY||Hazard Ratio (HR)|1.094||||0.7952|TWO_SIDED|95.0|0.554|2.164|||Regression, Cox|||Hazard ratio and the P-value are based on the Cox's proportional hazard regression model, adjusted for age, weight and baseline GSRS score. Hazard ratio (HR) is the ratio of hazard rates of Montelukast and placebo treatment groups. P-value is from the Wald test that HR is 1. CI = Wald confidence interval.||2.164|0.554|0.7952
72458582|NCT02410278|144439571|SUPERIORITY||Hazard Ratio (HR)|0.946||||0.8328|TWO_SIDED|95.0|0.563|1.589|||Regression, Cox|||Hazard ratio and the P-value are based on the Cox's proportional hazard regression model, adjusted for age, weight and baseline GSRS score. Hazard ratio (HR) is the ratio of hazard rates of Montelukast and placebo treatment groups. P-value is from the Wald test that HR is 1. CI = Wald confidence interval.||1.589|0.563|0.8328
72458583|NCT02410278|144439572|SUPERIORITY||adjusted mean difference|0.115||||0.1743|TWO_SIDED|95.0|-0.052|0.283|||Repeated measures model|||Change from Day 1 to Week 1: Results are obtained from a repeated measures model for change from baseline (Day 0) in the GSRS score. The model includes treatment, day and treatment by day interaction, adjusted for age, weight(kg) and baseline GSRS score, and has spatial-exponential variance-covariance structure. The P-value is for testing the null hypothesis of no difference between the two treatment groups in the average change from baseline (Day 0) between Day 1 and the specified time point.||0.283|-0.052|0.1743
72458584|NCT02410278|144439572|SUPERIORITY||adjusted mean difference|0.079||||0.2677|TWO_SIDED|95.0|-0.063|0.221|||Repeated measures model|||Change from Day 1 to Week 2: Results are obtained from a repeated measures model for change from baseline (Day 0) in the GSRS score. The model includes treatment, day and treatment by day interaction, adjusted for age, weight(kg) and baseline GSRS score, and has spatial-exponential variance-covariance structure. The P-value is for testing the null hypothesis of no difference between the two treatment groups in the average change from baseline (Day 0) between Day 1 and the specified time point.||0.221|-0.063|0.2677
72458585|NCT02410278|144439572|SUPERIORITY||adjusted mean difference|0.085||||0.1788|TWO_SIDED|95.0|-0.04|0.211|||Repeated measures model|||Change from Day 1 to Week 3: Results are obtained from a repeated measures model for change from baseline (Day 0) in the GSRS score. The model includes treatment, day and treatment by day interaction, adjusted for age, weight(kg) and baseline GSRS score, and has spatial-exponential variance-covariance structure. The P-value is for testing the null hypothesis of no difference between the two treatment groups in the average change from baseline (Day 0) between Day 1 and the specified time point.||0.211|-0.040|0.1788
72458586|NCT02410278|144439572|SUPERIORITY||adjusted mean difference|0.1||||0.0866|TWO_SIDED|95.0|-0.015|0.216|||Repeated measures model|||Change from Day 1 to Week 4: Results are obtained from a repeated measures model for change from baseline (Day 0) in the GSRS score. The model includes treatment, day and treatment by day interaction, adjusted for age, weight(kg) and baseline GSRS score, and has spatial-exponential variance-covariance structure. The P-value is for testing the null hypothesis of no difference between the two treatment groups in the average change from baseline (Day 0) between Day 1 and the specified time point.||0.216|-0.015|0.0866
72458587|NCT02410278|144439572|SUPERIORITY||adjusted mean difference|0.1||||0.0509|TWO_SIDED|95.0|0.0|0.201|||Repeated measures model|||Change from Day 1 to Week 5: Results are obtained from a repeated measures model for change from baseline (Day 0) in the GSRS score. The model includes treatment, day and treatment by day interaction, adjusted for age, weight(kg) and baseline GSRS score, and has spatial-exponential variance-covariance structure. The P-value is for testing the null hypothesis of no difference between the two treatment groups in the average change from baseline (Day 0) between Day 1 and the specified time point.||0.201|-0.000|0.0509
72500538|NCT03871491|144531276|SUPERIORITY||Risk Ratio (RR)|1.02||||0.56|TWO_SIDED|95.0|0.95|1.09||We calculated P values to test each of the primary hypotheses at an alpha level of 0.05 overall, with a nominal alpha level of 0.0001 at the interim analysis.|Regression, Logistic|Used multiple imputation for missing outcomes by means of logistic regression imputation.||The null hypothesis is there is no treatment effect on the incidence of Intrapartum/Neonatal Death or Sepsis Within 4 Weeks (28 Days) Post-delivery in Intervention vs. Placebo Group||1.09|0.95|0.56
72500539|NCT03871491|144531277|SUPERIORITY||Risk Ratio (RR)|0.65|||||TWO_SIDED|95.0|0.55|0.77||||||||0.77|0.55|
72500540|NCT03871491|144531278|SUPERIORITY||Risk Ratio (RR)|4.04|||||TWO_SIDED|95.0|0.45|36.14||||||||36.14|0.45|
72500541|NCT03871491|144531280|SUPERIORITY||Risk Ratio (RR)|0.66|||||TWO_SIDED|95.0|0.55|0.79||||||||0.79|0.55|
72458588|NCT02410278|144439572|SUPERIORITY||adjusted mean difference|0.088||||0.0649|TWO_SIDED|95.0|-0.006|0.182|||Repeated measures model|||Change from Day 1 to Week 6: Results are obtained from a repeated measures model for change from baseline (Day 0) in the GSRS score. The model includes treatment, day and treatment by day interaction, adjusted for age, weight(kg) and baseline GSRS score, and has spatial-exponential variance-covariance structure. The P-value is for testing the null hypothesis of no difference between the two treatment groups in the average change from baseline (Day 0) between Day 1 and the specified time point.||0.182|-0.006|0.0649
72458589|NCT02410278|144439572|SUPERIORITY||adjusted mean difference|0.088||||0.0479|TWO_SIDED|95.0|0.001|0.176|||Repeated measures model|||Change from Day 1 to Week 7: Results are obtained from a repeated measures model for change from baseline (Day 0) in the GSRS score. The model includes treatment, day and treatment by day interaction, adjusted for age, weight(kg) and baseline GSRS score, and has spatial-exponential variance-covariance structure. The P-value is for testing the null hypothesis of no difference between the two treatment groups in the average change from baseline (Day 0) between Day 1 and the specified time point.||0.176|0.001|0.0479
72458590|NCT02410278|144439572|SUPERIORITY||adjusted mean difference|0.082||||0.054|TWO_SIDED|95.0|-0.001|0.166|||Repeated measures model|||Change from Day 1 to Week 8: Results are obtained from a repeated measures model for change from baseline (Day 0) in the GSRS score. The model includes treatment, day and treatment by day interaction, adjusted for age, weight(kg) and baseline GSRS score, and has spatial-exponential variance-covariance structure. The P-value is for testing the null hypothesis of no difference between the two treatment groups in the average change from baseline (Day 0) between Day 1 and the specified time point.||0.166|-0.001|0.0540
72458591|NCT02410278|144439573|SUPERIORITY||adjusted mean difference|0.129||||0.2469|TWO_SIDED|95.0|-0.092|0.349|||Repeated measures model|||Results are obtained from a repeated measures model for change from baseline (Day 0) in the GSRS score. The model includes treatment, day and treatment by day interaction, adjusted for age, weight (kg) and baseline GSRS score, and has unstructured variance-covariance structure. The P-value is for testing the null hypothesis of no difference between the two treatment groups in the average change from baseline (Day 0) between Day 1 and Day 3.||0.349|-0.092|0.2469
72500542|NCT03871491|144531281|SUPERIORITY||Risk Ratio (RR)|0.57|||||TWO_SIDED|95.0|0.43|0.75||||||||0.75|0.43|
72500543|NCT03871491|144531282|SUPERIORITY||Risk Ratio (RR)|0.8|||||TWO_SIDED|95.0|0.65|0.99||||||||0.99|0.65|
72500544|NCT03871491|144531283|SUPERIORITY||Risk Ratio (RR)|0.69|||||TWO_SIDED|95.0|0.56|0.85||||||||0.85|0.56|
72500545|NCT03871491|144531284|SUPERIORITY||Risk Ratio (RR)|0.98|||||TWO_SIDED|95.0|0.95|1.01||||||||1.01|0.95|
72500546|NCT03871491|144531286|SUPERIORITY||Risk Ratio (RR)|0.65|||||TWO_SIDED|95.0|0.52|0.82||||||||0.82|0.52|
72500547|NCT03871491|144531287|SUPERIORITY||Risk Ratio (RR)|0.9|||||TWO_SIDED|95.0|0.7|1.15||||||||1.15|0.70|
72500548|NCT03871491|144531288|SUPERIORITY||Risk Ratio (RR)|0.79|||||TWO_SIDED|95.0|0.73|0.84||||||||0.84|0.73|
72500549|NCT03871491|144531289|SUPERIORITY||Risk Ratio (RR)|1.09|||||TWO_SIDED|95.0|0.84|1.41||||||||1.41|0.84|
72500550|NCT03871491|144531290|SUPERIORITY||Risk Ratio (RR)|1.03|||||TWO_SIDED|95.0|0.96|1.1||||||||1.1|0.96|
72620881|NCT00452400|144772825|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.061|STANDARD_ERROR_OF_MEAN|0.027||0.0233||95.0|0.008|0.113|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 2 mcg qd minus Placebo|||0.113|0.008|0.0233
72620882|NCT00452400|144772825|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.097|STANDARD_ERROR_OF_MEAN|0.027||0.0003||95.0|0.044|0.149|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 5 mcg qd minus Placebo|||0.149|0.044|0.0003
72500551|NCT03871491|144531291|SUPERIORITY||Risk Ratio (RR)|1.04|||||TWO_SIDED|95.0|0.73|1.47||||||||1.47|0.73|
72500552|NCT03871491|144531292|SUPERIORITY||Risk Ratio (RR)|0.97|||||TWO_SIDED|95.0|0.88|1.07||||||||1.07|0.88|
72500553|NCT03871491|144531294|SUPERIORITY||Risk Ratio (RR)|1.08|||||TWO_SIDED|95.0|0.96|1.21||||||||1.21|0.96|
72500554|NCT03871491|144531295|SUPERIORITY||Risk Ratio (RR)|1.03|||||TWO_SIDED|95.0|0.94|1.12||||||||1.12|0.94|
72500555|NCT03871491|144531296|SUPERIORITY||Risk Ratio (RR)|0.96|||||TWO_SIDED|95.0|0.93|1.0||||||||1.0|0.93|
72500556|NCT03871491|144531297|SUPERIORITY||Risk Ratio (RR)|2.68|||||TWO_SIDED|95.0|0.71|10.1||||||||10.1|0.71|
72500557|NCT05202808|144531300|NON_INFERIORITY|"The endothelial cell loss (ECL) at 6 months was compared between the LAL and Control groups. The statistical hypothesis is:~* H0: Median(LAL) - Median(control) ≥ 5% vs~* Ha: Median(LAL) - Median(control) \< 5%~The median ECL for the LAL group is at most 5% higher than the median ECL for the Control group.~The first co-primary safety endpoint is met if the median ECL of the LAL group is non-inferior to the Control group using a right-tail Wilcoxon test using a significance level of 0.05."|Median Difference (Final Values)|0.2|||<|0.0001|TWO_SIDED|90.0|-1.0|1.66|||Wilcoxon (Mann-Whitney)|||With a one-sided significance level of 0.05, a power of 0.80, a randomization ratio of 2:1, and then the Mann-Whitney-Wilcoxon asymptotic relative efficiency (A.R.E.) efficiency adjustment, the sample size per two-sample t-test is 192 LAL eyes and 96 Control eyes (total of 288), with an assumed dropout rate of 10%.||1.66|-1.00|<0.0001
72500558|NCT05202808|144531302|OTHER||Odds Ratio (OR)|4.61|||||TWO_SIDED|95.0|2.97|7.15|||||Light adjustable lens (LAL) and Light Delivery Device (LDD) group is the numerator and Control group is the denominator. At Month 6, the odds of achieving UCDVA of 20/20 or better were 4.61 times greater for the LAL group than the Control group.|||7.15|2.97|
72500559|NCT05202808|144531303|OTHER||Odds Ratio (OR)|20.74|||||TWO_SIDED|95.0|12.05|36.14|||||Light adjustable lens (LAL) and Light Delivery Device (LDD) group is the numerator and the Control group is the denominator. The odds of achieving Absolute MRCYL of 0.5D or less was 20.74 for the LAL group versus the Control group at month 6.|||36.14|12.05|
72500560|NCT05202808|144531304|OTHER||Odds Ratio (OR)|14.46|||||TWO_SIDED|95.0|8.89|23.57|||||Light adjustable lens (LAL) and Light Delivery Device (LDD) group is the numerator and the Control group is the denominator. The odds of achieving simultaneous Absolute MRSE and MRCL of 0.5 D or less was 14.46 in the LAL group vs. Control at month 6.|||23.57|8.89|
72500561|NCT02747004|144531327|SUPERIORITY|||||||0.293||||||Two-sided P-value.|Log Rank|Stratified by the randomization factors of presence of liver metastases and prior use of Tamoxifen in the advanced/metastatic setting.||||||0.2930
72620883|NCT00452400|144772825|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.123|STANDARD_ERROR_OF_MEAN|0.026|<|0.0001||95.0|0.072|0.175|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 10 mcg qd minus Placebo|||0.175|0.072|<0.0001
72458592|NCT02410278|144439574|SUPERIORITY|||||||1|||||||Chi-squared|||||||1.0000
72620884|NCT00452400|144772825|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.132|STANDARD_ERROR_OF_MEAN|0.027|<|0.0001||95.0|0.08|0.185|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 20 mcg qd minus Placebo|||0.185|0.080|<0.0001
72458593|NCT02410278|144439575|SUPERIORITY|||||||1|||||||Fisher's Exact|||||||1.0000
72458594|NCT02410278|144439576|SUPERIORITY|||||||0.2604|||||||Chi-squared|||||||0.2604
72458595|NCT02584257|144439583|SUPERIORITY||Least Square Means Differences|3.171|STANDARD_ERROR_OF_MEAN|0.238|<|0.0001|TWO_SIDED|95.0|2.732|3.61||Fixed effects of dose, week, and sequence and the random effect of the patient was carried out to ensure that the overall treatment effect was significant at p\<0.05|Brief Mixed Models Analysis|For this model, the dependent variable was log2(PC20FEV1) values where PC20FEV1 was measured in mg/mL||||3.610|2.732|<0.0001
72458596|NCT02584257|144439583|SUPERIORITY||Least Square Means Differences|3.824|STANDARD_ERROR_OF_MEAN|0.238|<|0.0001|TWO_SIDED|95.0|3.384|4.263||Fixed effects of dose, week, and sequence and the random effect of the patient was carried out to ensure that the overall treatment effect was significant at p\<0.05.|Brief Mixed Models Analysis|For this model, the dependent variable was log2(PC20FEV1) values where PC20FEV1 was measured in mg/mL||||4.263|3.384|<0.0001
72620885|NCT00452400|144772826|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.088|STANDARD_ERROR_OF_MEAN|0.025||0.0004||95.0|0.039|0.137|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 2 mcg qd minus Placebo|||0.137|0.039|0.0004
72370495|NCT00488683|144251632|SUPERIORITY_OR_OTHER||R-square|0.001||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between memory B cells one month after primary vaccination and hSBA titers one month after booster vaccination for the serogroup A||||
72458597|NCT02584257|144439583|SUPERIORITY||Least Square Means Differences|3.32|STANDARD_ERROR_OF_MEAN|0.241|<|0.0001|TWO_SIDED|95.0|2.876|3.764||Fixed effects of dose, week, and sequence and the random effect of the patient was carried out to ensure that the overall treatment effect was significant at p\<0.05.|Brief Mixed Models Analysis|For this model, the dependent variable was log2(PC20FEV1) values where PC20FEV1 was measured in mg/mL.||||3.764|2.876|<0.0001
72458598|NCT02584257|144439583|SUPERIORITY||Least Square Means Differences|3.872|STANDARD_ERROR_OF_MEAN|0.24|<|0.0001|TWO_SIDED|95.0|3.43|4.315||Fixed effects of dose, week, and sequence and the random effect of the patient was carried out to ensure that the overall treatment effect was significant at p\<0.05.|Brief Mixed Models Analysis|For this model, the dependent variable was log2(PC20FEV1) values where PC20FEV1 was measured in mg/mL||||4.315|3.430|<0.0001
72470016|NCT03732677|144464074|SUPERIORITY||Hazard Ratio (HR)|0.75||||0.0021|TWO_SIDED|95.0|0.62|0.9|||Chi-squared|P-value is based on a chi-squared test with one degree of freedom.|The HR and CI were estimated from a stratified Cox proportional hazard model adjusting for renal function (adequate vs borderline), tumor stage (T2N0 vs \>T2N0) and PDL1 status (high vs low/negative)|||0.90|0.62|0.0021
72470017|NCT03732677|144464075|SUPERIORITY||Odds Ratio (OR)|1.48||||0.0265|TWO_SIDED|95.0|1.047|2.095|||Regression, Logistic|Stratified by renal function(adequate vs borderline),tumor stage(T2N0 vs \>T2N0), PDL1 status(high vs low/negative)|Strata adjusted odds ratio by the logistic regression method. Stratified by adjusting for renal function (adequate vs borderline), tumor stage (T2N0 vs \>T2N0) and PDL1 status (high vs low/negative).|||2.095|1.047|0.0265
72470018|NCT03732677|144464076|SUPERIORITY||Hazard Ratio (HR)|0.75||||0.0106|TWO_SIDED|98.457|0.563|0.985|||Log Rank|Stratified by renal function (adequate vs borderline),tumor stage(T2N0vs \>T2N0), PDL1 status(high vs low/negative)|||95% CI: 0.594 to 0.934|0.985|0.563|0.0106
72470019|NCT03732677|144464077|SUPERIORITY||Hazard Ratio (HR)|0.67||||0.0002|TWO_SIDED|95.0|0.541|0.826|||Log Rank|Stratified by renal function(adequate vs borderline),tumor stage(T2N0 vs \>T2N0), PDL1 status(high vs low/negative)|The HR and CI were estimated from a stratified Cox proportional hazard model adjusting for renal function (adequate vs borderline), tumor stage (T2N0 vs \>T2N0) and PDL1 status (high vs low/negative)|||0.826|0.541|0.0002
72470020|NCT03732677|144464078|SUPERIORITY||Hazard Ratio (HR)|0.69||||0.0081|TWO_SIDED|95.0|0.516|0.907|||Log Rank|Stratified by renal function(adequate vs borderline),tumor stage(T2N0 vs \>T2N0), PDL1 status(high vs low/negative)|The HR and CI were estimated from a stratified Cox proportional hazard model adjusting for renal function (adequate vs borderline), tumor stage (T2N0 vs \>T2N0) and PDL1 status (high vs low/negative)|||0.907|0.516|0.0081
72470021|NCT04535544|144464313|SUPERIORITY||Difference of percentage|23.7||||0.011|TWO_SIDED|95.0|3.52|43.96|||Mantel-Haenszel|||Stratum-adjusted Mantel-Haenszel (MH) test was used to assess the difference of percentage based on stratification factor: HBeAg status at screening (positive vs negative).||43.96|3.52|0.011
72470022|NCT04535544|144464314|SUPERIORITY||Difference of percentage|26.8||||0.003|TWO_SIDED|95.0|7.38|46.21|||Mantel-Haenszel|||Stratum-adjusted MH test was used to assess the difference of percentage based on stratification factor: HBeAg status at screening (positive vs negative).||46.21|7.38|0.003
72470023|NCT05131477|144464323|SUPERIORITY||LS Mean Difference|-32.1|STANDARD_ERROR_OF_MEAN|6.01|<|0.0001|TWO_SIDED|95.0|-43.9|-20.3|||ANCOVA||LS Mean Difference|||-20.3|-43.9|<0.0001
72470024|NCT05131477|144464323|SUPERIORITY||LS Mean Difference|-27.3|STANDARD_ERROR_OF_MEAN|5.98|<|0.0001|TWO_SIDED|95.0|-39.1|-15.6|||ANCOVA||LS Mean Difference|||-15.6|-39.1|<0.0001
72470025|NCT05131477|144464323|SUPERIORITY||LS Mean Difference|-22.2|STANDARD_ERROR_OF_MEAN|6.01||0.0002|TWO_SIDED|95.0|-34.0|-10.4|||ANCOVA||LS Mean Difference|||-10.4|-34.0|0.0002
72470026|NCT05131477|144464323|SUPERIORITY||Mean Difference (Final Values)|-30.2|STANDARD_ERROR_OF_MEAN|5.95|<|0.0001|TWO_SIDED|95.0|-41.9|-18.5|||ANCOVA|||||-18.5|-41.9|<0.0001
72470027|NCT05131477|144464324|SUPERIORITY||LS Mean Difference|-36.8|STANDARD_ERROR_OF_MEAN|6.62|<|0.0001|TWO_SIDED|95.0|-49.8|-23.8|||ANCOVA||LS Mean Difference|||-23.8|-49.8|<0.0001
72470028|NCT05131477|144464324|SUPERIORITY||LS Mean Difference|-24.6|STANDARD_ERROR_OF_MEAN|6.67||0.0002|TWO_SIDED|95.0|-37.7|-11.6|||ANCOVA||LS Mean Difference|||-11.6|-37.7|0.0002
72470029|NCT05131477|144464324|SUPERIORITY||LS Mean Difference|-26.2|STANDARD_ERROR_OF_MEAN|6.65|<|0.0001|TWO_SIDED|95.0|-39.2|-13.1|||ANCOVA||LS Mean Difference|||-13.1|-39.2|<0.0001
72458599|NCT02584257|144439583|EQUIVALENCE|A blinded interim analysis was performed after 60 patients completed all treatment visits which determined that 80 subjects would be sufficient to complete the study with 90% power.|Frel|1.15|STANDARD_ERROR_OF_MEAN|0.17|||TWO_SIDED|90.0|0.93|1.48|||||Frel is the relative bioavailability of the test versus reference product. The CI was a bias corrected and accelerated CI based on a bootstrapping procedure. The FDA acceptable CI was between 0.67 and 1.50.|An Emax model was developed and the 90% confidence interval of Frel was a bias corrected accelerated confidence interval based on a bootstrapping procedure. The bootstrapping procedure used for this analysis was residual resampling. The Per-Protocol population was the primary population for bioequivalence analysis. Patients in the PP population must have completed at least 2 treatment periods with valid PC20FEV1 measurements and had no major protocol deviations within those intervals.||1.48|0.93|
72458600|NCT03693989|144439593|OTHER|||||||0.065|||||||t-test, 2 sided|The study analysis was comparative, it was only sought to determine if the difference between treatments is statistically significant or not.||||||0.065
72458601|NCT03693989|144439594|OTHER|The study analysis was comparative, it was only sought to determine if the difference between treatments is statistically significant or not.||||||0.223|||||||t-test, 2 sided|||||||0.223
72458602|NCT03693989|144439595|OTHER|The study analysis was comparative, it was only sought to determine if the difference between treatments is statistically significant or not.||||||0.621|||||||Chi-squared, Corrected|||||||0.621
72458603|NCT03693989|144439596|OTHER|The study analysis was comparative, it was only sought to determine if the difference between treatments is statistically significant or not.||||||0.246|||||||Fisher Exact|||||||0.246
72458604|NCT03693989|144439597|OTHER|The study analysis was comparative, it was only sought to determine if the difference between treatments is statistically significant or not.||||||0.497|||||||Fisher Exact|||||||0.497
72458605|NCT03693989|144439598|OTHER|The study analysis was comparative, it was only sought to determine if the difference between treatments is statistically significant or not.||||||0.047|||||||t-test, 2 sided|||||||0.047
72458606|NCT03693989|144439599|OTHER|The study analysis was comparative, it was only sought to determine if the difference between treatments is statistically significant or not.||||||0.3|||||||Chi-squared, Corrected|||||||0.300
72458607|NCT03693989|144439600|OTHER|The study analysis was comparative, it was only sought to determine if the difference between treatments is statistically significant or not.||||||0.045|||||||t-test, 2 sided|||||||0.045
72458608|NCT03693989|144439601|OTHER|The study analysis was comparative, it was only sought to determine if the difference between treatments is statistically significant or not.||||||0.346|||||||Fisher Exact|||burning eyes comparison||||0.346
72458609|NCT03693989|144439601|OTHER|The study analysis was comparative, it was only sought to determine if the difference between treatments is statistically significant or not.||||||0.489|||||||Fisher Exact|||Itching eyes comparison||||0.489
72458610|NCT03693989|144439601|OTHER|The study analysis was comparative, it was only sought to determine if the difference between treatments is statistically significant or not.||||||0.497|||||||Fisher Exact|||foreign body sensation eyes comparison||||0.497
72458611|NCT03693989|144439601|OTHER|The study analysis was comparative, it was only sought to determine if the difference between treatments is statistically significant or not.||||||1|||||||Fisher Exact|||blurred vision comparison||||1.000
72458612|NCT03403153|144439627|OTHER||||||<|0.01|||||||t-test, 1 sided|||||||<0.01
72458613|NCT03403153|144439628|OTHER||||||<|0.01|||||||t-test, 1 sided|||||||<.01
72458614|NCT03403153|144439629|OTHER||||||<|0.01|||||||t-test, 1 sided|||||||<.01
72458615|NCT03403153|144439630|OTHER||||||<|0.01|||||||t-test, 1 sided|||||||<.01
72458616|NCT03403153|144439631|OTHER||||||<|0.01|||||||t-test, 1 sided|||||||<.01
72458617|NCT03403153|144439632|OTHER||||||<|0.01|||||||t-test, 1 sided|||||||<.01
72458618|NCT03403153|144439633|OTHER||||||<|0.01|||||||t-test, 1 sided|||||||<.01
72458619|NCT03031782|144439692|SUPERIORITY||Cox Proportional Hazard|0.28|||<|0.001|TWO_SIDED|95.0|0.13|0.63|||Log Rank|Hazard ratios and associated 95% confidence intervals are based on a Cox proportional hazards model with treatment and analysis factors||Survival analysis of time to flare - TP2 (FAS2)||0.63|0.13|<0.001
72458620|NCT00886834|144439709|SUPERIORITY_OR_OTHER|||||||0.64||95.0|||||t-test, 2 sided|||||||0.64
72458621|NCT03122860|144439711|SUPERIORITY||Median Difference (Final Values)|-0.46||||0.179|TWO_SIDED|95.0|-1.13|0.21|||ANCOVA|||||0.21|-1.13|0.179
72458622|NCT03122860|144439711|SUPERIORITY||Median Difference (Final Values)|-0.7||||0.031|TWO_SIDED|95.0|-1.34|-0.06|||ANCOVA|||||-0.06|-1.34|0.031
72458623|NCT03122860|144439711|SUPERIORITY||Mean Difference (Final Values)|-0.14||||0.675|TWO_SIDED|95.0|-0.81|0.52|||ANCOVA|||||0.52|-0.81|0.675
72458624|NCT03122860|144439711|SUPERIORITY||Mean Difference (Final Values)|-0.82||||0.022|TWO_SIDED|95.0|-1.51|-0.12|||ANCOVA|||||-0.12|-1.51|0.022
72458625|NCT03122860|144439711|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.78|TWO_SIDED|95.0|-0.79|0.59|||ANCOVA|||||0.59|-0.79|0.780
72458626|NCT03122860|144439712|SUPERIORITY||Mean Difference (Final Values)|-1.7||||0.612|TWO_SIDED|95.0|-8.32|4.91|||ANCOVA|||||4.91|-8.32|0.612
72458627|NCT03122860|144439712|SUPERIORITY||Mean Difference (Final Values)|-4.01||||0.223|TWO_SIDED|95.0|-10.47|2.46|||ANCOVA|||||2.46|-10.47|0.223
72458628|NCT03122860|144439712|SUPERIORITY||Mean Difference (Final Values)|1.84||||0.59|TWO_SIDED|95.0|-4.89|8.57|||ANCOVA|||||8.57|-4.89|0.590
72458629|NCT03122860|144439712|SUPERIORITY||Mean Difference (Final Values)|-7.36||||0.031|TWO_SIDED|95.0|-14.03|-0.69|||ANCOVA|||||-0.69|-14.03|0.031
72458630|NCT03122860|144439712|SUPERIORITY||Mean Difference (Final Values)|-2.89||||0.403|TWO_SIDED|95.0|-9.7|3.92|||ANCOVA|||||3.92|-9.70|0.403
72458631|NCT03122860|144439713|SUPERIORITY||Mean Difference (Final Values)|-2.58||||0.432|TWO_SIDED|95.0|-9.04|3.88|||ANCOVA|||||3.88|-9.04|0.432
72458632|NCT03122860|144439713|SUPERIORITY||Mean Difference (Final Values)|-4.34||||0.18|TWO_SIDED|95.0|-10.69|2.02|||ANCOVA|||||2.02|-10.69|0.180
72458633|NCT03122860|144439713|SUPERIORITY||Mean Difference (Final Values)|1.19||||0.718|TWO_SIDED|95.0|-5.33|7.72|||ANCOVA|||||7.72|-5.33|0.718
72458634|NCT03122860|144439713|SUPERIORITY||Mean Difference (Final Values)|-7.99||||0.017|TWO_SIDED|95.0|-14.54|-1.45|||ANCOVA|||||-1.45|-14.54|0.017
72458635|NCT03122860|144439713|SUPERIORITY||Mean Difference (Final Values)|-1.39||||0.682|TWO_SIDED|95.0|-8.06|5.29|||ANCOVA|||||5.29|-8.06|0.682
72458636|NCT03122860|144439714|SUPERIORITY||Mean Difference (Final Values)|0.02||||0.822|TWO_SIDED|95.0|-0.16|0.21|||ANCOVA|||||0.21|-0.16|0.822
72458637|NCT03122860|144439714|SUPERIORITY||Mean Difference (Final Values)|-0.11||||0.162|TWO_SIDED|95.0|-0.27|0.04|||ANCOVA|||||0.04|-0.27|0.162
72458638|NCT03122860|144439714|SUPERIORITY||Mean Difference (Final Values)|-0.12||||0.267|TWO_SIDED|95.0|-0.34|0.09|||ANCOVA|||||0.09|-0.34|0.267
72620886|NCT00452400|144772826|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.137|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001||95.0|0.088|0.186|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 5 mcg qd minus Placebo|||0.186|0.088|<0.0001
72620887|NCT00452400|144772826|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.128|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001||95.0|0.08|0.176|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 10 mcg qd minus Placebo|||0.176|0.080|<0.0001
72620888|NCT00452400|144772826|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.169|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001||95.0|0.12|0.218|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 20 mcg qd minus Placebo|||0.218|0.120|<0.0001
72458639|NCT03122860|144439714|SUPERIORITY||Mean Difference (Final Values)|-0.03||||0.685|TWO_SIDED|95.0|-0.18|0.12|||ANCOVA|||||0.12|-0.18|0.685
72458640|NCT03122860|144439714|SUPERIORITY||Mean Difference (Final Values)|0.08||||0.342|TWO_SIDED|95.0|-0.09|0.24|||ANCOVA|||||0.24|-0.09|0.342
72458641|NCT03122860|144439715|SUPERIORITY||Mean Difference (Final Values)|-2.13||||0.5|TWO_SIDED|95.0|-8.36|4.1|||ANCOVA|||||4.10|-8.36|0.500
72458642|NCT03122860|144439715|SUPERIORITY||Mean Difference (Final Values)|-5.54||||0.082|TWO_SIDED|95.0|-11.8|0.72|||ANCOVA|||||0.72|-11.80|0.082
72458643|NCT03122860|144439715|SUPERIORITY||Mean Difference (Final Values)|-1.94||||0.552|TWO_SIDED|95.0|-8.36|4.48|||ANCOVA|||||4.48|-8.36|0.552
72458644|NCT03122860|144439715|SUPERIORITY||Mean Difference (Final Values)|-6.86||||0.033|TWO_SIDED|95.0|-13.16|-0.56|||ANCOVA|||||-0.56|-13.16|0.033
72458645|NCT03122860|144439715|SUPERIORITY||Mean Difference (Final Values)|0.45||||0.887|TWO_SIDED|95.0|-5.79|6.68|||ANCOVA|||||6.68|-5.79|0.887
72458646|NCT03122860|144439716|SUPERIORITY||Mean Difference (Final Values)|-2.14||||0.473|TWO_SIDED|95.0|-7.99|3.72|||ANCOVA|||||3.72|-7.99|0.473
72458647|NCT03122860|144439716|SUPERIORITY||Mean Difference (Final Values)|-6.31||||0.04|TWO_SIDED|95.0|-12.33|-0.29|||ANCOVA|||||-0.29|-12.33|0.040
72458648|NCT03122860|144439716|SUPERIORITY||Mean Difference (Final Values)|1.72||||0.577|TWO_SIDED|95.0|-4.35|7.79|||ANCOVA|||||7.79|-4.35|0.577
72458649|NCT03122860|144439716|SUPERIORITY||Mean Difference (Final Values)|-8.95||||0.003|TWO_SIDED|95.0|-14.9|-3.01|||ANCOVA|||||-3.01|-14.90|0.003
72458650|NCT03122860|144439716|SUPERIORITY||Mean Difference (Final Values)|-0.21||||0.947|TWO_SIDED|95.0|-6.37|5.96|||ANCOVA|||||5.96|-6.37|0.947
72458651|NCT03122860|144439717|SUPERIORITY||Mean Difference (Final Values)|-3.05||||0.299|TWO_SIDED|95.0|-8.83|2.73|||ANCOVA|||||2.73|-8.83|0.299
72458652|NCT03122860|144439717|SUPERIORITY||Mean Difference (Final Values)|-7.18||||0.021|TWO_SIDED|95.0|-13.24|-1.12|||ANCOVA|||||-1.12|-13.24|0.021
72458653|NCT03122860|144439717|SUPERIORITY||Mean Difference (Final Values)|1.29||||0.675|TWO_SIDED|95.0|-4.75|7.33|||ANCOVA|||||7.33|-4.75|0.675
72458654|NCT03122860|144439717|SUPERIORITY||Mean Difference (Final Values)|-8.63||||0.006|TWO_SIDED|95.0|-14.7|-2.55|||ANCOVA|||||-2.55|-14.70|0.006
72458655|NCT03122860|144439717|SUPERIORITY||Mean Difference (Final Values)|0.3||||0.925|TWO_SIDED|95.0|-5.99|6.59|||ANCOVA|||||6.59|-5.99|0.925
72458656|NCT03122860|144439718|SUPERIORITY||Mean Difference (Final Values)|-0.58||||0.062|TWO_SIDED|95.0|-1.18|0.03|||ANCOVA|||||0.03|-1.18|0.062
72458657|NCT03122860|144439718|SUPERIORITY||Mean Difference (Final Values)|-0.96||||0.001|TWO_SIDED|95.0|-1.54|-0.37|||ANCOVA|||||-0.37|-1.54|0.001
72458658|NCT03122860|144439718|SUPERIORITY||Mean Difference (Final Values)|-0.12||||0.693|TWO_SIDED|95.0|-0.75|0.5|||ANCOVA|||||0.50|-0.75|0.693
72458659|NCT03122860|144439718|SUPERIORITY||Mean Difference (Final Values)|-0.78||||0.012|TWO_SIDED|95.0|-1.39|-0.17|||ANCOVA|||||-0.17|-1.39|0.012
72458660|NCT03122860|144439718|SUPERIORITY||Mean Difference (Final Values)|0.12||||0.697|TWO_SIDED|95.0|-0.49|0.74|||ANCOVA|||||0.74|-0.49|0.697
72458661|NCT03122860|144439719|SUPERIORITY||Mean Difference (Final Values)|-3.32||||0.254|TWO_SIDED|95.0|-9.04|2.4|||ANCOVA|||||2.40|-9.04|0.254
72458662|NCT03122860|144439719|SUPERIORITY||Mean Difference (Final Values)|-6.86||||0.031|TWO_SIDED|95.0|-13.1|-0.63|||ANCOVA|||||-0.63|-13.10|0.031
72458663|NCT03122860|144439719|SUPERIORITY||Mean Difference (Final Values)|-1.46||||0.616|TWO_SIDED|95.0|-7.2|4.28|||ANCOVA|||||4.28|-7.20|0.616
72458664|NCT03122860|144439719|SUPERIORITY||Mean Difference (Final Values)|-7.62||||0.01|TWO_SIDED|95.0|-13.41|-1.82|||ANCOVA|||||-1.82|-13.41|0.010
72458665|NCT03122860|144439719|SUPERIORITY||Mean Difference (Final Values)|-0.14||||0.961|TWO_SIDED|95.0|-5.74|5.46|||ANCOVA|||||5.46|-5.74|0.961
72458666|NCT01138657|144439720|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.5|||<|0.001|TWO_SIDED|95.0|0.36|0.7|||Log Rank|||The primary analysis of the primary endpoint was performed on Main Study data, excluding the Japanese sub-study. The statistical test was performed at a 2-sided significance level of 0.05. The hazard ratio of adalimumab versus placebo was calculated using proportional hazards regression with treatment as factor.||0.70|0.36|<0.001
72458667|NCT01138657|144439720|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.56|||<|0.001|TWO_SIDED|95.0|0.4|0.76|||Log Rank|||An additional analysis of the primary endpoint was performed using the Integrated Study data (Main Study + Japan sub-study). The statistical test was performed at a 2-sided significance level of 0.05. The hazard ratio of adalimumab versus placebo was calculated using proportional hazards regression with treatment and race (Japanese versus non-Japanese) as factors.||0.76|0.40|< 0.001
72470030|NCT05131477|144464324|SUPERIORITY||LS Mean Difference|-26.8|STANDARD_ERROR_OF_MEAN|6.58|<|0.0001|TWO_SIDED|95.0|-39.7|-13.9|||ANCOVA||LS Mean Difference|||-13.9|-39.7|<0.0001
72470031|NCT05131477|144464325|SUPERIORITY||Proportion Difference|0.29|||<|0.0001|TWO_SIDED|95.0|0.16|0.42|||Cochran-Mantel-Haenszel|||Week 16||0.42|0.16|< 0.0001
72470032|NCT05131477|144464325|SUPERIORITY||Proportion Difference|0.27|||<|0.0001|TWO_SIDED|95.0|0.14|0.4|||Cochran-Mantel-Haenszel|||Week 16||0.40|0.14|< 0.0001
72470033|NCT05131477|144464325|SUPERIORITY||Proportion Difference|0.31|||<|0.0001|TWO_SIDED|95.0|0.18|0.44|||Cochran-Mantel-Haenszel|||Week 16||0.44|0.18|<0.0001
72458668|NCT01138657|144439721|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference|-0.29||||0.011|TWO_SIDED|95.0|-0.51|-0.07|||ANOVA|ANOVA with treatment as factor adjusted for clustered observations (i.e., observations from each of the participant's eyes).|The mean difference between treatment groups with its 95% confidence interval is based on individual data from all eyes adjusted for correlated measurements within a subject in an analysis of variance (ANOVA) model.|The statistical test for the ranked secondary variables was carried out in hierarchical order at the significance level of 5%.||-0.07|-0.51|0.011
72458669|NCT01138657|144439721|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference|-0.25||||0.019|TWO_SIDED|95.0|-0.46|-0.04|||ANOVA|ANOVA with treatment and race (Japanese versus non-Japanese) as factors adjusted for clustered observations (from each of the participant's eyes).|The mean difference between treatment groups with its 95% confidence interval is based on individual data from all eyes adjusted for correlated measurements within a subject in an analysis of variance (ANOVA) model.|The statistical test for the ranked secondary variables was carried out in hierarchical order at the significance level of 5%.||-0.04|-0.46|0.019
72458670|NCT01138657|144439722|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference|-0.27|||<|0.001|TWO_SIDED|95.0|-0.43|-0.11|||ANOVA|ANOVA with treatment as factor adjusted for clustered observations.|The mean difference between treatment groups with its 95% confidence interval is based on individual data from all eyes adjusted for correlated measurements within a subject in an analysis of variance (ANOVA) model.|The statistical test for the ranked secondary variables was carried out in hierarchical order at the significance level of 5%.||-0.11|-0.43|<0.001
72458671|NCT01138657|144439722|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference|-0.28|||<|0.001|TWO_SIDED|95.0|-0.43|-0.12|||ANOVA|ANOVA with treatment and race (Japanese versus non-Japanese) as factors adjusted for clustered observations.|The mean difference between treatment groups with its 95% confidence interval is based on individual data from all eyes adjusted for correlated measurements within a subject in an analysis of variance (ANOVA) model.|The statistical test for the ranked secondary variables was carried out in hierarchical order at the significance level of 5%.||-0.12|-0.43|<0.001
72500562|NCT02747004|144531327|OTHER|Informal phase 2 non-inferiority.|Hazard Ratio (HR)|1.045|||||TWO_SIDED|95.0|0.711|1.535|||Log Rank|Stratified by the randomization factors of presence of liver metastases and prior use of Tamoxifen in the advanced/metastatic setting.||||1.535|0.711|
72620889|NCT00452400|144772827|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.085|STANDARD_ERROR_OF_MEAN|0.026||0.0011||95.0|0.034|0.136|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 2 mcg qd minus Placebo|||0.136|0.034|0.0011
72458672|NCT01138657|144439723|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference|-0.07||||0.003|TWO_SIDED|95.0|-0.11|-0.02|||ANOVA|ANOVA with treatment as factor adjusted for clustered observations.|The mean difference between treatment groups with its 95% confidence interval is based on individual data from all eyes adjusted for correlated measurements within a subject in an analysis of variance (ANOVA) model.|The statistical test for the ranked secondary variables was carried out in hierarchical order at the significance level of 5%.||-0.02|-0.11|0.003
72458673|NCT01138657|144439723|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference|-0.06||||0.008|TWO_SIDED|95.0|-0.1|-0.02|||ANOVA|ANOVA with treatment and race (Japanese versus non-Japanese) as factors adjusted for clustered observations.|The mean difference between treatment groups with its 95% confidence interval is based on individual data from all eyes adjusted for correlated measurements within a subject in an analysis of variance (ANOVA) model.|The statistical test for the ranked secondary variables was carried out in hierarchical order at the significance level of 5%.||-0.02|-0.10|0.008
72458674|NCT01138657|144439724|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.7||||0.231|TWO_SIDED|95.0|0.39|1.26|||Log Rank||The hazard ratio of adalimumab versus placebo was calculated using proportional hazards regression with treatment as factor.|The statistical test for the ranked secondary variables was carried out in hierarchical order at the significance level of 5%.||1.26|0.39|0.231
72458675|NCT01138657|144439724|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.68||||0.191|TWO_SIDED|95.0|0.38|1.21|||Log Rank||The hazard ratio of adalimumab versus placebo was calculated using proportional hazards regression with treatment and race (Japanese versus non-Japanese) as factors.|The statistical test for the ranked secondary variables was carried out in hierarchical order at the significance level of 5%.||1.21|0.38|0.191
72458676|NCT01138657|144439725|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference|-11.4||||0.02|TWO_SIDED|95.0|-20.9|-1.8|||ANOVA|ANOVA with treatment and OCT machine as factors adjusted for clustered observations.|The mean difference between treatment groups with its 95% confidence interval is based on individual data from all eyes adjusted for correlated measurements within a subject in an analysis of variance (ANOVA) model.|The statistical test for the ranked secondary variables was carried out in hierarchical order at the significance level of 5%.||-1.8|-20.9|0.020
72458677|NCT01138657|144439725|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference|-5.1||||0.428|TWO_SIDED|95.0|-17.7|7.5|||Chi-squared, Corrected|ANOVA with treatment, race (Japanese versus non-Japanese) and OCT machine as factors adjusted for clustered observations.|The mean difference between treatment groups with its 95% confidence interval is based on individual data from all eyes adjusted for correlated measurements within a subject in an analysis of variance (ANOVA) model.|The statistical test for the ranked secondary variables was carried out in hierarchical order at the significance level of 5%.||7.5|-17.7|0.428
72458678|NCT01138657|144439726|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference|4.2||||0.01|TWO_SIDED|95.0|1.02|7.38|||ANOVA|ANOVA with treatment as a factor.||The statistical test for the ranked secondary variables was carried out in hierarchical order at the significance level of 5%.||7.38|1.02|0.010
72500563|NCT05087030|144531339|NON_INFERIORITY|The analysis was performed with an ANCOVA model with %CfB in lumbar spine BMD at Week 52 as the dependent variable, covariates were treatment arm (RGB-14-P and US-licensed Prolia).|Estimated Difference|0.18|||||TWO_SIDED|90.0|-0.465|0.826|||ANCOVA|||||0.826|-0.465|
72500564|NCT05087030|144531339|SUPERIORITY|Non-Superiority Test|Estimated Difference|0.55|||||TWO_SIDED|90.0|-0.099|1.191|||ANCOVA|||||1.191|-0.099|
72500565|NCT05087030|144531340|OTHER||Geometric mean ratio|1.01||||0.494|TWO_SIDED|95.0|0.978|1.046|||ANCOVA|||Comparison between Study Treatment Groups||1.046|0.978|0.494
72500566|NCT05087030|144531341|OTHER||Estimated difference|-0.31||||0.199|TWO_SIDED|95.0|-0.792|0.165|||Mixed model repeated measures|||at Week 26||0.165|-0.792|0.199
72500567|NCT05087030|144531341|OTHER||Estimated difference|-0.16||||0.543|TWO_SIDED|95.0|-0.68|0.358|||mixed model repeated measures|||At Week 52||0.358|-0.680|0.543
72458679|NCT01138657|144439726|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference|3.67||||0.019|TWO_SIDED|95.0|0.62|6.71|||ANOVA|ANOVA with treatment and race (Japanese versus non-Japanese) as factors.||The statistical test for the ranked secondary variables was carried out in hierarchical order at the significance level of 5%.||6.71|0.62|0.019
72458680|NCT01138657|144439727|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference|1.86||||0.346|TWO_SIDED|95.0|-2.03|5.75|||ANOVA|ANOVA with treatment as a factor.||The statistical test for the ranked secondary variables was carried out in hierarchical order at the significance level of 5%.||5.75|-2.03|0.346
72458681|NCT01138657|144439727|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference|1.31||||0.496|TWO_SIDED|95.0|-2.47|5.09|||ANOVA|ANOVA with treatment and race (Japanese versus non-Japanese) as factors.||The statistical test for the ranked secondary variables was carried out in hierarchical order at the significance level of 5%.||5.09|-2.47|0.496
72458682|NCT01138657|144439728|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference|5.12||||0.036|TWO_SIDED|95.0|0.34|9.9|||ANOVA|ANOVA with treatment as a factor.||The statistical test for the ranked secondary variables was carried out in hierarchical order at the significance level of 5%.||9.90|0.34|0.036
72458683|NCT01138657|144439728|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference|4.14||||0.077|TWO_SIDED|95.0|-0.45|8.72|||ANOVA|ANOVA with treatment and race (Japanese versus non-Japanese) as factors.||The statistical test for the ranked secondary variables was carried out in hierarchical order at the significance level of 5%.||8.72|-0.45|0.077
72458684|NCT01138657|144439729|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference|10.02|||<|0.001|TWO_SIDED|95.0|4.86|15.19|||ANOVA|ANOVA with treatment as a factor.||The statistical test for the ranked secondary variables was carried out in hierarchical order at the significance level of 5%.||15.19|4.86|<0.001
72500568|NCT05087030|144531342|OTHER||Estimated Difference|0.03||||0.929|TWO_SIDED|95.0|-0.703|0.769|||mixed model for repeated measures|||Week 26||0.769|-0.703|0.929
72500569|NCT01444300|144531352|SUPERIORITY_OR_OTHER|||||||0.51|||||||t-test, 2 sided|||t test comparing change in outcome between active and placebo||||0.51
72500570|NCT01444300|144531353|SUPERIORITY_OR_OTHER|||||||0.7|||||||t-test, 2 sided|||t test comparing change in outcome between active and placebo after 12 weeks.||||0.7
72500571|NCT01444300|144531354|SUPERIORITY_OR_OTHER|||||||0.8|||||||t-test, 2 sided|||t test comparing change in outcome between active and placebo||||0.8
72620890|NCT00452400|144772827|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.121|STANDARD_ERROR_OF_MEAN|0.026|<|0.0001||95.0|0.07|0.173|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 5 mcg qd minus Placebo|||0.173|0.070|<0.0001
72620891|NCT00452400|144772827|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.125|STANDARD_ERROR_OF_MEAN|0.026|<|0.0001||95.0|0.075|0.175|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 10 mcg qd minus Placebo|||0.175|0.075|<0.0001
72458685|NCT01138657|144439729|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference|8.83|||<|0.001|TWO_SIDED|95.0|3.88|13.79|||ANOVA|ANOVA with treatment and race (Japanese versus non-Japanese) as factors.||The statistical test for the ranked secondary variables was carried out in hierarchical order at the significance level of 5%||13.79|3.88|<0.001
72458686|NCT00999336|144439730|OTHER|Geometric least squares means, ratios, and confidence intervals (CIs) were estimated from an analysis of covariance (ANCOVA) of natural log transformed values.|Ratio|1.89|||||TWO_SIDED|90.0|1.18|3.03|||||Statistical comparison of AUC0-24 on Day 8 for participants grouped using 186 as a multiplier in the Modified Diet in Renal Disease Study Group (MDRD) equation.|||3.03|1.18|
72458687|NCT00999336|144439730|OTHER|Geometric least squares means, ratios, and CIs were estimated from an ANCOVA of natural log transformed values.|Ratio|2.27|||||TWO_SIDED|90.0|1.43|3.59|||||Statistical comparison of AUC0-24 on Day 8 for participants grouped using 186 as multiplier in the MDRD equation.|||3.59|1.43|
72458688|NCT00999336|144439730|OTHER|Geometric least squares means, ratios, and CIs were estimated from an ANCOVA of natural log transformed values.|Ratio|2.63|||||TWO_SIDED|90.0|1.71|4.06|||||Statistical comparison of AUC0-24 on Day 8 for participants grouped using 186 as multiplier in the MDRD equation.|||4.06|1.71|
72458689|NCT00999336|144439730|OTHER|Geometric least squares means, ratios, and CIs were estimated from an ANCOVA of natural log transformed values.|Ratio|1.39|||||TWO_SIDED|90.0|0.888|2.18|||||Statistical comparison of AUC0-24 on Day 8 for participants grouped using 186 as multiplier in the MDRD equation.|||2.18|0.888|
72458690|NCT00999336|144439730|OTHER|Geometric least squares means, ratios, and CIs were estimated from an ANCOVA of natural log transformed values.|Ratio|1.94|||||TWO_SIDED|90.0|1.14|3.31|||||Statistical comparison of AUC0-24 on Day 8 for participants grouped using 175 as multiplier in the MDRD equation.|||3.31|1.14|
72500572|NCT00490542|144531355|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.4|||||TWO_SIDED|95.0|0.6|10.2||||||||10.2|0.6|
72500573|NCT03658954|144531356|SUPERIORITY|||||||0.75|||||||Mixed Models Analysis|||Testing for group effect.||||0.75
72500574|NCT03658954|144531357|SUPERIORITY|||||||0.05|||||||Mixed Models Analysis|||Testing for group effect.||||0.05
72500575|NCT03658954|144531358|SUPERIORITY|||||||0.02|||||||Mixed Models Analysis|||Testing for group effect.||||0.02
72500576|NCT02863198|144531373|SUPERIORITY_OR_OTHER||||||<|0.05||||||All included p-values are calculated from collected data and not threshold values for statical significance|t-test, 2 sided|||||||<0.05
72500577|NCT02863198|144531374|SUPERIORITY_OR_OTHER||||||<|0.05||||||All included p-values are calculated from collected data and not threshold values for statical significance|t-test, 2 sided|||||||<0.05
72500578|NCT02863198|144531375|SUPERIORITY_OR_OTHER||||||<|0.05||||||All included p-values are calculated from collected data and not threshold values for statical significance|Chi-squared|||||||<0.05
72500579|NCT02863198|144531376|SUPERIORITY_OR_OTHER||||||<|0.05||||||All included p-values are calculated from collected data and not threshold values for statical significance|t-test, 2 sided|||||||<0.05
72500580|NCT02863198|144531377|SUPERIORITY_OR_OTHER||||||<|0.05||||||All included p-values are calculated from collected data and not threshold values for statical significance|t-test, 2 sided|||||||<0.05
72500581|NCT02863198|144531378|SUPERIORITY_OR_OTHER||||||<|0.05||||||All included p-values are calculated from collected data and not threshold values for statical significance|Chi-squared|||||||<0.05
72500582|NCT00666562|144531410|SUPERIORITY_OR_OTHER|||||||0.046|TWO_SIDED||||||t-test, 2 sided|||||||0.046
72500583|NCT01587989|144531425|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.327||||0.188|TWO_SIDED|95.0|-0.165|0.82|||t-test, 2 sided|||||0.820|-0.165|0.188
72563046|NCT02093923|144658126|SUPERIORITY||Percent Change in Mean Rate|-82.38|||<|0.0001|TWO_SIDED|95.0|-92.5|-58.64|||Mixed Models Analysis|||The result was based on General Estimating Equation (GEE) analysis. Generalized Estimating Equation (GEE) approach with Poisson distribution assumption was applied to the repeated-measures mixed model with independence working correlation structure. The treatment group was a fixed effect and the number of baseline HAE attacks per week was included as a covariate in the GEE.||-58.64|-92.50|<.0001
72458691|NCT00999336|144439730|OTHER|Geometric least squares means, ratios, and CIs were estimated from an ANCOVA of natural log transformed values.|Ratio|2.44|||||TWO_SIDED|90.0|1.41|4.22|||||Statistical comparison of AUC0-24 on Day 8 for participants grouped using 175 as multiplier in the MDRD equation.|||4.22|1.41|
72458692|NCT00999336|144439730|OTHER|Geometric least squares means, ratios, and CIs were estimated from an ANCOVA of natural log transformed values.|Ratio|2.86|||||TWO_SIDED|90.0|1.74|4.7|||||Statistical comparison of AUC0-24 on Day 8 for participants grouped using 175 as multiplier in the MDRD equation.|||4.7|1.74|
72458693|NCT00999336|144439730|OTHER|Geometric least squares means, ratios, and CIs were estimated from an ANCOVA of natural log transformed values.|Ratio|1.47|||||TWO_SIDED|90.0|0.944|2.3|||||Statistical comparison of AUC0-24 on Day 8 for participants grouped using 175 as multiplier in the MDRD equation.|||2.3|0.944|
72458694|NCT00999336|144439731|OTHER|Geometric least squares means, ratios, and CIs were estimated from an ANCOVA of natural log transformed values.|Ratio|1.88|||||TWO_SIDED|90.0|1.05|3.35|||||Statistical comparison of Cmax on Day 8 for participants grouped using 186 as multiplier in the MDRD equation.|||3.35|1.05|
72458695|NCT00999336|144439731|OTHER|Geometric least squares means, ratios, and CIs were estimated from an ANCOVA of natural log transformed values.|Ratio|2.32|||||TWO_SIDED|90.0|1.32|4.07|||||Statistical comparison of Cmax on Day 8 for participants grouped using 186 as multiplier in the MDRD equation.|||4.07|1.32|
72458696|NCT00999336|144439731|OTHER|Geometric least squares means, ratios, and CIs were estimated from an ANCOVA of natural log transformed values.|Ratio|2.52|||||TWO_SIDED|90.0|1.48|4.29|||||Statistical comparison of Cmax on Day 8 for participants grouped using 186 as multiplier in the MDRD equation.|||4.29|1.48|
72458697|NCT00999336|144439731|OTHER|Geometric least squares means, ratios, and CIs were estimated from an ANCOVA of natural log transformed values.|Ratio|1.34|||||TWO_SIDED|90.0|0.772|2.32|||||Statistical comparison of Cmax on Day 8 for participants grouped using 186 as multiplier in the MDRD equation.|||2.32|0.772|
72458698|NCT00999336|144439731|OTHER|Geometric least squares means, ratios, and CIs were estimated from an ANCOVA of natural log transformed values.|Ratio|1.96|||||TWO_SIDED|90.0|1.01|3.78|||||Statistical comparison of Cmax on Day 8 for participants grouped using 175 as multiplier in the MDRD equation.|||3.78|1.01|
72458699|NCT00999336|144439731|OTHER|Geometric least squares means, ratios, and CIs were estimated from an ANCOVA of natural log transformed values.|Ratio|2.38|||||TWO_SIDED|90.0|1.21|4.67|||||Statistical comparison of Cmax on Day 8 for participants grouped using 175 as multiplier in the MDRD equation.|||4.67|1.21|
72458700|NCT00999336|144439731|OTHER|Geometric least squares means, ratios, and CIs were estimated from an ANCOVA of natural log transformed values.|Ratio|2.69|||||TWO_SIDED|90.0|1.46|4.96|||||Statistical comparison of Cmax on Day 8 for participants grouped using 175 as multiplier in the MDRD equation.|||4.96|1.46|
72458701|NCT00999336|144439731|OTHER|Geometric least squares means, ratios, and CIs were estimated from an ANCOVA of natural log transformed values.|Ratio|1.37|||||TWO_SIDED|90.0|0.793|2.38|||||Statistical comparison of Cmax on Day 8 for participants grouped using 175 as multiplier in the MDRD equation.|||2.38|0.793|
72458702|NCT00960206|144439756|SUPERIORITY_OR_OTHER|||||||0.0832|||||||Log Rank|||To compare the Kaplan-Meier survivorship between the two systems||||0.0832
72620892|NCT00452400|144772827|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.128|STANDARD_ERROR_OF_MEAN|0.026|<|0.0001||95.0|0.077|0.179|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 20 mcg qd minus Placebo|||0.179|0.077|<0.0001
72458703|NCT00960206|144439756|SUPERIORITY_OR_OTHER|||||||0.1657|||||||Log Rank|||To compare the Kaplan-Meier survivorship between the two systems||||0.1657
72458704|NCT00960206|144439757|SUPERIORITY_OR_OTHER|||||||0.3701|||||||Fisher Exact|||To compare the # of cases at 10 years for those that have a HHS ≥ 80 to those that have \< 80 for all three arms||||0.3701
72458705|NCT00960206|144439759|SUPERIORITY_OR_OTHER|||||||0.6011|||||||Fisher Exact|||Compare the # of cases at 10 years satisfied with their total hip replacement for all three groups||||0.6011
72370496|NCT00488683|144251632|SUPERIORITY_OR_OTHER||R-square|0.22||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and hSBA titers one month after booster vaccination for the serogroup C||||
72458706|NCT00960206|144439759|SUPERIORITY_OR_OTHER|||||||0.206|||||||Fisher Exact|||Compare the # of cases at 10 years for having pain in their hip for all three groups||||0.2060
72458707|NCT02158806|144439811|SUPERIORITY|Participants analysed in the groups to which they were randomised (intention to treat analysis).|Cox Proportional Hazard|0.85|STANDARD_ERROR_OF_MEAN|0.146||0.246|TWO_SIDED|95.0|0.64|1.13|||Log Rank||Placebo group = reference group|Placebo group = reference group||1.13|0.64|0.246
72458708|NCT02158806|144439812|SUPERIORITY|Participants analysed in the groups to which they were randomised (intention to treat analysis).|Risk Ratio (RR)|0.88||||0.073|TWO_SIDED|95.0|0.76|1.01|||Chi-squared|||||1.01|0.76|0.073
72458709|NCT02158806|144439813|SUPERIORITY||Mean Difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|0.6||0.25|TWO_SIDED|95.0|-1.9|0.5||Adjusted for baseline values.|ANCOVA|One participant in aspirin group had missing data for 24 week endpoint visit; we used the baseline value for imputation.|Placebo group = reference group.|||0.5|-1.9|0.25
72458710|NCT02158806|144439814|SUPERIORITY||Mean Difference (Net)|1.1||||0.714|TWO_SIDED|95.0|-5.0|7.2|||Regression, Linear|Adjusted for baseline values||Change in Physical Functioning||7.2|-5.0|0.714
72458711|NCT02158806|144439814|SUPERIORITY||Mean Difference (Net)|1.4||||0.768|TWO_SIDED|95.0|-8.0|10.8|||Regression, Linear|Adjusted for baseline values||Change in Role Physical||10.8|-8.0|0.768
72458712|NCT02158806|144439814|SUPERIORITY||Mean Difference (Net)|2.3||||0.449|TWO_SIDED|95.0|-3.7|8.4|||Regression, Linear|Adjusted for baseline values||Change in Bodily Pain||8.4|-3.7|0.449
72458713|NCT02158806|144439814|SUPERIORITY||Mean Difference (Net)|-0.3||||0.873|TWO_SIDED|95.0|-4.3|3.6|||Regression, Linear|Adjusted for baseline values||Change in General Health||3.6|-4.3|0.873
72500584|NCT01587989|144531425|SUPERIORITY_OR_OTHER|||||||0.015|TWO_SIDED||||||ANCOVA|||At Week 12.||||0.015
72458714|NCT02158806|144439814|SUPERIORITY||Mean Difference (Net)|4.2||||0.057|TWO_SIDED|95.0|-0.1|8.5|||Regression, Linear|Adjusted for baseline values||Change in Vitality||8.5|-0.1|0.057
72500585|NCT01587989|144531425|SUPERIORITY_OR_OTHER|||||||0.304|TWO_SIDED||||||ANCOVA|||Adjusted change in DAS28 score from Weeks 12-24.||||0.304
72500586|NCT01587989|144531426|SUPERIORITY_OR_OTHER|||||||0.732|TWO_SIDED||||||Fisher Exact|||||||0.732
72500587|NCT01587989|144531427|SUPERIORITY_OR_OTHER|||||||0.207|TWO_SIDED||||||Fisher Exact|||||||0.207
72500588|NCT01587989|144531428|SUPERIORITY_OR_OTHER|||||||0.453|TWO_SIDED||||||Fisher Exact|||||||0.453
72500589|NCT01587989|144531429|SUPERIORITY_OR_OTHER|||||||0.084|TWO_SIDED||||||Fisher Exact|||||||0.084
72500590|NCT01587989|144531430|SUPERIORITY_OR_OTHER|||||||0.842|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.842
72500591|NCT01587989|144531431|SUPERIORITY_OR_OTHER|||||||0.417|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Physical standardized value||||0.417
72500592|NCT01587989|144531431|SUPERIORITY_OR_OTHER|||||||0.112|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Mental standardized value||||0.112
72500593|NCT01587989|144531432|SUPERIORITY_OR_OTHER|||||||0.655|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Fatigue||||0.655
72500594|NCT01587989|144531432|SUPERIORITY_OR_OTHER|||||||0.839|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Pain||||0.839
72500595|NCT01587989|144531433|SUPERIORITY_OR_OTHER|||||||0.58|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Effectiveness||||0.580
72500596|NCT01587989|144531433|SUPERIORITY_OR_OTHER|||||||0.975|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Side-effects||||0.975
72500597|NCT01587989|144531433|SUPERIORITY_OR_OTHER|||||||0.421|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Convenience||||0.421
72500598|NCT01587989|144531433|SUPERIORITY_OR_OTHER|||||||0.277|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Global satisfaction||||0.277
72500599|NCT00275561|144531436|SUPERIORITY_OR_OTHER|||||||0.74||95.0|||||Fisher Exact|||||||0.74
72458715|NCT02158806|144439814|SUPERIORITY||Mean Difference (Net)|1.0||||0.756|TWO_SIDED|95.0|-5.1|7.0|||Regression, Linear|Adjusted for baseline values||Change in Social Functioning||7.0|-5.1|0.756
72458716|NCT02158806|144439814|SUPERIORITY||Mean Difference (Net)|3.7||||0.4|TWO_SIDED|95.0|-4.9|12.3|||Regression, Linear|Adjusted for baseline values||Change in Role Emotional||12.3|-4.9|0.400
72458717|NCT02158806|144439814|SUPERIORITY||Mean Difference (Net)|-2.3||||0.236|TWO_SIDED|95.0|-6.2|1.5|||Regression, Linear|Adjusted for baseline values||Change in Mental Health||1.5|-6.2|0.236
72458718|NCT02158806|144439815|SUPERIORITY||Mean Difference (Net)|3.4||||0.156|TWO_SIDED|95.0|-1.3|8.0||Adjusted for baseline values|Regression, Linear|||||8.0|-1.3|0.156
72458719|NCT02158806|144439816|SUPERIORITY||Mean Difference (Net)|-1.5||||0.438|TWO_SIDED|95.0|-5.2|2.2|||Regression, Linear|Adjusted for baseline values||Change in social function||2.2|-5.2|0.438
72500600|NCT00275561|144531437|SUPERIORITY_OR_OTHER|||||||0.49||95.0|||||Fisher Exact|||||||0.49
72500601|NCT00275561|144531438|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Fisher Exact|||||||<0.001
72500602|NCT03128957|144531444|EQUIVALENCE|Given the small sample permutation are feasible.||||||0.036|||||||permutation test|Given the non-parametric nature of spearman's correlation coefficient and a small sample we used a permutation test to calculate p-values.||Non-parametric covariance adjusted Spearman's correlation ρ\_s. To test the Null that Ho: ρ\_s.=0 vs alternative that Ha: ρ\_s.≠0, we used a method that calculates the probability that it would be greater than or equal to the observed ρ ̂, given the null hypothesis, by using a permutation test. An advantage of this approach is that it automatically takes into account the number of tied data values in the sample and the way they are treated in computing the rank correlation.||||0.036
72500603|NCT03128957|144531445|SUPERIORITY|||||||0.015|||||||Kruskal-Wallis|||Set point 1 (FiO2 0.3 and PaCO2 30 mmHg) compared to set point 2 (FiO2 1.0 and PaCO2 40 mmHg)||||0.015
72500604|NCT03128957|144531446|SUPERIORITY|||||||0.047|||||||Kruskal-Wallis|||Set point 1 (FiO2 0.3 and PaCO2 30 mmHg) compared to set point 2 (FiO2 1.0 and PaCO2 40 mmHg)||||0.047
72500605|NCT00684177|144531447|SUPERIORITY_OR_OTHER||Risk Difference (RD)|8.4||||0.098|TWO_SIDED|95.0|-1.6|18.4|||Chi-squared|||||18.4|-1.6|0.098
72500606|NCT00684177|144531448|SUPERIORITY_OR_OTHER||Risk Difference (RD)|12.1||||0.04|TWO_SIDED|95.0|0.6|23.6|||Chi-squared|||||23.6|0.6|0.04
72500607|NCT00684177|144531449|SUPERIORITY_OR_OTHER||Risk Difference (RD)|12.1||||0.04|TWO_SIDED|95.0|0.6|23.6|||Chi-squared|||||23.6|0.6|0.04
72500608|NCT04178590|144531500|SUPERIORITY|||||||0.429||||||p\<0.05|Wilcoxon (Mann-Whitney)|||||||0.429
72500609|NCT04178590|144531501|SUPERIORITY|||||||0||||||p\<0.05|Wilcoxon (Mann-Whitney)|||||||0.000
72458720|NCT02158806|144439816|SUPERIORITY||Mean Difference (Net)|-1.3||||0.408|TWO_SIDED|95.0|-4.5|1.9|||Regression, Linear|Adjusted for baseline values||Change in domestic activities||1.9|-4.5|0.408
72500610|NCT04178590|144531502|SUPERIORITY|||||||0||||||p\<0.05|Wilcoxon (Mann-Whitney)|||||||0.000
72500611|NCT04178590|144531503|SUPERIORITY|||||||0||||||p\<0.05|Wilcoxon (Mann-Whitney)|||||||0.000
72500612|NCT04178590|144531504|SUPERIORITY|||||||0.575||||||p\<0.05|Wilcoxon (Mann-Whitney)|||||||0.575
72500613|NCT04178590|144531505|SUPERIORITY|||||||0.575||||||p\<0.05|Wilcoxon (Mann-Whitney)|||||||0.575
72500614|NCT04178590|144531506|SUPERIORITY|||||||0.249||||||p\<0.05|Wilcoxon (Mann-Whitney)|||||||0.249
72500615|NCT04178590|144531507|SUPERIORITY|||||||0.871||||||p\<0.05|Wilcoxon (Mann-Whitney)|||||||0.871
72500616|NCT04178590|144531508|SUPERIORITY|||||||0.773||||||p\<0.05|Wilcoxon (Mann-Whitney)|||||||0.773
72500617|NCT04178590|144531509|SUPERIORITY|||||||0||||||p\<0.05|Wilcoxon (Mann-Whitney)|||||||0.000
72500618|NCT04178590|144531510|SUPERIORITY|||||||0||||||p\<0.05|Wilcoxon (Mann-Whitney)|p\<0.05||||||0.000
72500619|NCT04178590|144531511|SUPERIORITY|||||||0||||||p\<0.05|Wilcoxon (Mann-Whitney)|||||||0.000
72500620|NCT04178590|144531512|SUPERIORITY|||||||0.063||||||p\<0.05|Wilcoxon (Mann-Whitney)|||||||0.063
72500621|NCT04178590|144531513|SUPERIORITY|||||||0||||||p\<0.05|Wilcoxon (Mann-Whitney)|||||||0.000
72500622|NCT04178590|144531514|SUPERIORITY|||||||0||||||p\<0.05|Wilcoxon (Mann-Whitney)|||||||0.000
72500623|NCT04178590|144531515|SUPERIORITY|||||||0||||||p\<0.05|Wilcoxon (Mann-Whitney)|||||||0.000
72500624|NCT04178590|144531516|SUPERIORITY|||||||0.085||||||p\<0.05|Wilcoxon (Mann-Whitney)|||||||0.085
72500625|NCT04178590|144531517|SUPERIORITY|||||||0||||||p\<0.05|Wilcoxon (Mann-Whitney)|||||||0.000
72500626|NCT04178590|144531518|SUPERIORITY|||||||0||||||p\<0.05|Wilcoxon (Mann-Whitney)|||||||0.000
72500627|NCT04178590|144531519|SUPERIORITY|||||||0.895||||||p\<0.05|Wilcoxon (Mann-Whitney)|||||||0.895
72370497|NCT00488683|144251632|SUPERIORITY_OR_OTHER||R-square|0.08||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between memory B cells one month after primary vaccination and hSBA titers one month after booster vaccination for the serogroup C||||
72458721|NCT02158806|144439816|SUPERIORITY||Mean Difference (Net)|-1.3||||0.568|TWO_SIDED|95.0|-5.6|3.1|||Regression, Linear|Adjusted for baseline values||Change in cosmesis||3.1|-5.6|0.568
72458722|NCT02158806|144439816|SUPERIORITY||Mean Difference (Net)|-3.0||||0.257|TWO_SIDED|95.0|-8.1|2.2|||Regression, Linear|Adjusted for baseline values||Change in emotional status||2.2|-8.1|0.257
72458723|NCT02158806|144439816|SUPERIORITY||Mean Difference (Net)|-1.9||||0.273|TWO_SIDED|95.0|-5.2|1.5|||Regression, Linear|Adjusted for baseline values||||1.5|-5.2|0.273
72458724|NCT02158806|144439817|SUPERIORITY||Risk Ratio (RR)|1.01||||0.917|TWO_SIDED|95.0|0.87|1.17|||Chi-squared|||||1.17|0.87|0.917
72458725|NCT02158806|144439818|SUPERIORITY||Incidence Rate Ratio|1.1||||0.71|TWO_SIDED|95.0|0.7|1.7|||IRR test statistic|Incidence Rate Ratio (IRR) test statistic compared to probability of the same obtained from standard normal distribution tables.||||1.7|0.7|0.71
72458726|NCT01898299|144439819|SUPERIORITY||Cohen's d effectsize|0.48||||0.036|TWO_SIDED||||||ANCOVA|Control for Chlopromazine equivalents||||||0.036
72458727|NCT02340806|144439820|SUPERIORITY|||||||0.67|||||||Chi-squared, Corrected|||||||.67
72458728|NCT02340806|144439821|SUPERIORITY|||||||0.08|||||||Wilcoxon (Mann-Whitney)|||||||.08
72458729|NCT02340806|144439822|SUPERIORITY|||||||0.21|||||||Wilcoxon (Mann-Whitney)|||||||.21
72458730|NCT02340806|144439823|SUPERIORITY|||||||0.14|||||||Wilcoxon (Mann-Whitney)|||||||.14
72458731|NCT02340806|144439824|SUPERIORITY|||||||0.66|||||||Kruskal-Wallis|||||||.66
72458732|NCT02340806|144439826|SUPERIORITY|||||||0.92|||||||Wilcoxon (Mann-Whitney)|||||||.92
72458733|NCT02340806|144439827|SUPERIORITY|||||||0.58|||||||Kruskal-Wallis|||||||.58
72458734|NCT02340806|144439828|SUPERIORITY|||||||0.67|||||||Chi-squared|||||||.67
72458735|NCT02340806|144439829|SUPERIORITY|||||||0.99|||||||Chi-squared|||||||.99
72458736|NCT02340806|144439830|SUPERIORITY|||||||0.37|||||||Kruskal-Wallis|||||||.37
72458737|NCT04520256|144439859|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<.001
72458738|NCT04520256|144439860|SUPERIORITY||Estimated Change|-0.27||||0.693|TWO_SIDED|95.0|-0.54|0.01|||Mixed Models Analysis|||||0.01|-.54|0.693
72458739|NCT04520256|144439860|SUPERIORITY||Estimated Change|0.09||||0.9|TWO_SIDED|95.0|0.01|0.18|||Mixed Models Analysis|||||0.18|0.01|0.900
72458740|NCT04520256|144439860|SUPERIORITY||Estimated Change|-0.03||||0.96|TWO_SIDED|95.0|-0.06|0.01|||Mixed Models Analysis|||||0.01|-0.06|0.960
72458741|NCT04520256|144439860|SUPERIORITY||Estimated Change|0.44||||0.113|TWO_SIDED|95.0|0.01|0.88|||Mixed Models Analysis|||||0.88|0.01|0.113
72458742|NCT04520256|144439860|SUPERIORITY||Estimated Change|0.92||||0.187|TWO_SIDED|95.0|0.01|1.84|||Mixed Models Analysis|||||1.84|0.01|0.187
72458743|NCT04520256|144439861|SUPERIORITY|||||||0.999|||||||Mixed Models Analysis|||||||0.999
72458744|NCT04520256|144439862|SUPERIORITY||Estimated Proportion|0.12||||0.999|TWO_SIDED|95.0|0.0|0.56|||Mixed Models Analysis|||||.56|0|.999
72458745|NCT04520256|144439862|SUPERIORITY||Estimated Proportion|0.15||||0.999|TWO_SIDED|95.0|0.0|0.68|||Mixed Models Analysis|||||.68|0|.999
72458746|NCT04520256|144439862|SUPERIORITY||Estimated Proportion|0.11||||0.999|TWO_SIDED|95.0|0.0|0.52|||Mixed Models Analysis|||||.52|0|.999
72458747|NCT04520256|144439862|SUPERIORITY||Estimated Proportion|0.11||||0.999|TWO_SIDED|95.0|0.0|0.5|||Mixed Models Analysis|||||.50|0|.999
72458748|NCT04520256|144439862|SUPERIORITY||Estimated Proportion|0.1||||0.999|TWO_SIDED|95.0|0.0|0.47|||Mixed Models Analysis|||||.47|0|.999
72458749|NCT05492786|144439863|SUPERIORITY|||||||0.517||||||The p-value reported is 2-tailed and based on heteroskedasticity-robust standard errors.|Regression, Linear|||Null hypothesis: there is no difference in flu shots for patients whose clinicians were shown alerts with information about their risk status (patients randomized to the High-risk Alert or High-risk Alert with Risk Factors arms) compared with those whose clinicians were shown the standard alert. Alternative hypothesis: patients in the High-risk Alert and High-risk Alert with Risk Factors arms will exhibit improved flu vaccination rates compared with those in the standard Alert arm.||||0.517
72458750|NCT05492786|144439863|SUPERIORITY|||||||0.226||||||The p-value reported is 2-tailed and based on heteroskedasticity-robust standard errors.|Regression, Linear|||Null hypothesis: there is no difference in flu shots for patients whose clinicians were shown alerts the factors that contributed to a patient's high risk (High-risk Alert with Risk Factors arm) compared with those whose clinicians were shown the alert with risk level only (High-risk Alert arm). Alternative hypothesis: patients in the High-risk Alert with Risk Factors arm will exhibit improved flu vaccination rates compared with those in the High-risk Alert arm.||||0.226
72458751|NCT02221934|144439880|SUPERIORITY||Risk Difference (RD)|0.176||||0.002|TWO_SIDED|95.0|0.07|0.283|||Regression, Logistic||Difference in Responders between groups presented.|||0.283|0.070|0.002
72458752|NCT00264576|144439893|NON_INFERIORITY_OR_EQUIVALENCE|To demonstrate non-inferiority of cTIV to eTIV\_f the lower limit of the 95% confidence interval (CI) around the ratio of the postvaccination GMTs had to be \>0.5.|Ratio of GMT|0.85|||||TWO_SIDED|95.0|0.7|1.04|||ANOVA|||"The following hypotheses were tested for A/H1N1 strain as measured by HI egg-derived assay:~H0i: log(GMTeTIV\_f(i)) - log(GMTcTIV(i)) ≥0.301 ↔ GMTcTIV(i) / GMTeTIV\_f(i) ≤0.5 (null hypothesis); H1i: log(GMTeTIV\_f(i)) - log(GMTcTIV(i)) \<0.301 ↔ GMTcTIV(i) / GMTeTIV\_f(i) \>0.5 (alternative hypothesis); With: GMTcTIV(i)=GMT for strain i in cTIV group; GMTeTIV\_f(i)=GMT for strain i in eTIV\_f group."||1.04|0.70|
72458753|NCT00264576|144439893|NON_INFERIORITY_OR_EQUIVALENCE|To demonstrate non-inferiority of cTIV to eTIV\_f the lower limit of the 95% confidence interval (CI) around the ratio of the postvaccination GMTs had to be \>0.5.|Ratio of GMT|0.57|||||TWO_SIDED|95.0|0.46|0.7|||ANOVA|||"The following hypotheses were tested for A/H3N2 strain as measured by HI egg-derived assay:~H0i: log(GMTeTIV\_f(i)) - log(GMTcTIV(i)) ≥0.301 ↔ GMTcTIV(i) / GMTeTIV\_f(i) ≤0.5 (null hypothesis); H1i: log(GMTeTIV\_f(i)) - log(GMTcTIV(i)) \<0.301 ↔ GMTcTIV(i) / GMTeTIV\_f(i) \>0.5 (alternative hypothesis); With: GMTcTIV(i)=GMT for strain i in cTIV group; GMTeTIV\_f(i)=GMT for strain i in eTIV\_f group."||0.70|0.46|
72470034|NCT05131477|144464325|SUPERIORITY||Proportion Difference|0.29|||<|0.0001|TWO_SIDED|95.0|0.16|0.42|||Cochran-Mantel-Haenszel|||Week 16||0.42|0.16|<0.0001
72470035|NCT05131477|144464325|SUPERIORITY||Proportion Difference|0.36|||<|0.0001|TWO_SIDED|95.0|0.23|0.5|||Cochran-Mantel-Haenszel|||Week 24||0.5|0.23|<0.0001
72458754|NCT00264576|144439893|NON_INFERIORITY_OR_EQUIVALENCE|To demonstrate non-inferiority of cTIV to eTIV\_f the lower limit of the 95% confidence interval (CI) around the ratio of the postvaccination GMTs had to be \>0.5.|Ratio of GMT|1.14|||||TWO_SIDED|95.0|0.95|1.36|||ANOVA|||"The following hypotheses were tested for B strain as measured by HI egg-derived assay:~H0i: log(GMTeTIV\_f(i)) - log(GMTcTIV(i)) ≥0.301 ↔ GMTcTIV(i) / GMTeTIV\_f(i) ≤0.5 (null hypothesis); H1i: log(GMTeTIV\_f(i)) - log(GMTcTIV(i)) \<0.301 ↔ GMTcTIV(i) / GMTeTIV\_f(i) \>0.5 (alternative hypothesis); With: GMTcTIV(i)=GMT for strain i in cTIV group; GMTeTIV\_f(i)=GMT for strain i in eTIV\_f group."||1.36|0.95|
72458755|NCT00264576|144439893|NON_INFERIORITY_OR_EQUIVALENCE|To demonstrate non-inferiority of cTIV to eTIV\_f the lower limit of the 95% confidence interval (CI) around the ratio of the postvaccination geometric mean titers (GMTs) had to be \>0.5.|Ratio of GMT|0.92|||||TWO_SIDED|95.0|0.76|1.12|||ANOVA|||"The following hypotheses were tested for A/H1N1 strain as measured by HI cell-culture-derived assay:~H0i: log(GMTeTIV\_f(i)) - log(GMTcTIV(i)) ≥0.301 ↔ GMTcTIV(i) / GMTeTIV\_f(i) ≤0.5 (null hypothesis); H1i: log(GMTeTIV\_f(i)) - log(GMTcTIV(i)) \<0.301 ↔ GMTcTIV(i) / GMTeTIV\_f(i) \>0.5 (alternative hypothesis); With: GMTcTIV(i)=GMT for strain i in cTIV group; GMTeTIV\_f(i)=GMT for strain i in eTIV\_f group."||1.12|0.76|
72500628|NCT04178590|144531520|SUPERIORITY|||||||0.999||||||p\<0.05|McNemar|||||||0.999
72500629|NCT04178590|144531521|SUPERIORITY|||||||0||||||p\<0.05|McNemar|||||||0.000
72500630|NCT04178590|144531522|SUPERIORITY|||||||0.008||||||p\<0.05|McNemar|||||||0.008
72500631|NCT04178590|144531523|SUPERIORITY|||||||0.5||||||p\<0.05|McNemar|||||||0.500
72500632|NCT04178590|144531524|SUPERIORITY|||||||0.999||||||p\<0.05|McNemar|||||||0.999
72620893|NCT00452400|144772828|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.11|STANDARD_ERROR_OF_MEAN|0.044||0.0127||95.0|0.024|0.197|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 2 mcg qd minus Placebo|||0.197|0.024|0.0127
72620894|NCT00452400|144772828|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.174|STANDARD_ERROR_OF_MEAN|0.044|<|0.0001||95.0|0.087|0.261|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 5 mcg qd minus Placebo|||0.261|0.087|<0.0001
72620895|NCT00452400|144772828|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.17|STANDARD_ERROR_OF_MEAN|0.043||0.0001||95.0|0.084|0.255|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 10 mcg qd minus Placebo|||0.255|0.084|0.0001
72500633|NCT04178590|144531525|SUPERIORITY|||||||0||||||p\<0.05|McNemar|||||||0.000
72500634|NCT04178590|144531526|SUPERIORITY|||||||0.4||||||p\<0.05|McNemar|||||||0.40
72370498|NCT00488683|144251632|SUPERIORITY_OR_OTHER||R-square|0.1||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and hSBA titers one month after booster vaccination for the serogroup W-135||||
72470036|NCT05131477|144464325|SUPERIORITY||Proportion Difference|0.21||||0.004|TWO_SIDED|95.0|0.07|0.34|||Cochran-Mantel-Haenszel|||Week 24||0.34|0.07|0.0040
72500635|NCT04178590|144531527|SUPERIORITY|||||||0.999|||||||McNemar|||||||0.999
72470037|NCT05131477|144464325|SUPERIORITY||Proportion Difference|0.31|||<|0.0001|TWO_SIDED|95.0|0.17|0.45|||Cochran-Mantel-Haenszel|||||0.45|0.17|<0.0001
72470038|NCT05131477|144464325|SUPERIORITY||Proportion Difference|0.23||||0.0016|TWO_SIDED|95.0|0.09|0.36|||Cochran-Mantel-Haenszel|||||0.36|0.09|0.0016
72470039|NCT05131477|144464326|SUPERIORITY||Proportion Difference|0.17||||0.0022|TWO_SIDED|95.0|0.06|0.27|||Cochran-Mantel-Haenszel|||Week 16||0.27|0.06|0.0022
72470040|NCT05131477|144464326|SUPERIORITY||Proportion Difference|0.09||||0.0562|TWO_SIDED|95.0|0.0|0.18|||Cochran-Mantel-Haenszel|||Week 16||0.18|0|0.0562
72470041|NCT05131477|144464326|SUPERIORITY||Proportion Difference|0.14||||0.0054|TWO_SIDED|95.0|0.04|0.24|||Cochran-Mantel-Haenszel|||Week 16||0.24|0.04|0.0054
72470042|NCT05131477|144464326|SUPERIORITY||Proportion Difference|0.2||||0.0003|TWO_SIDED|95.0|0.1|0.31|||Cochran-Mantel-Haenszel|||Week 16||0.31|0.1|0.0003
72470043|NCT05131477|144464326|SUPERIORITY||Proportion Difference|0.34|||<|0.0001|TWO_SIDED|95.0|0.21|0.47|||Cochran-Mantel-Haenszel|||Week 24||0.47|0.21|<0.0001
72500636|NCT04178590|144531528|SUPERIORITY|||||||0.999||||||p\<0.05|McNemar|||||||0.999
72470044|NCT05131477|144464326|SUPERIORITY||Proportion Difference|0.22||||0.0008|TWO_SIDED|95.0|0.1|0.34|||Cochran-Mantel-Haenszel|||Week 24||0.34|0.1|0.0008
72470045|NCT05131477|144464326|SUPERIORITY||Proportion Difference|0.29|||<|0.0001|TWO_SIDED|95.0|0.16|0.41|||Cochran-Mantel-Haenszel|||Week 24||0.41|0.16|<0.0001
72500637|NCT04178590|144531529|SUPERIORITY|||||||0.001||||||p\<0.05|McNemar|||||||0.001
72500638|NCT04178590|144531530|SUPERIORITY|||||||0.453||||||p\<0.05|McNemar|||||||0.453
72500639|NCT04178590|144531531|SUPERIORITY|||||||0.625||||||p\<0.05|McNemar|||||||0.625
72500640|NCT04178590|144531532|SUPERIORITY|||||||0.999|||||||McNemar|||||||0.999
72500641|NCT04178590|144531533|SUPERIORITY|||||||0||||||p\<0.05|McNemar|||||||0.000
72500642|NCT04178590|144531534|SUPERIORITY|||||||0.001||||||p\<0.05|McNemar|||||||0.001
72500643|NCT04178590|144531535|SUPERIORITY|||||||0.065||||||p\<0.05|McNemar|||||||0.065
72500644|NCT04178590|144531536|SUPERIORITY|||||||0.821||||||p\<0.05|Wilcoxon (Mann-Whitney)|||||||0.821
72500645|NCT04178590|144531537|SUPERIORITY|||||||0||||||p\<0.05|Wilcoxon (Mann-Whitney)|||||||0.000
72500646|NCT04178590|144531538|SUPERIORITY|||||||0.001||||||p\<0.05|Wilcoxon (Mann-Whitney)|||||||0.001
72500647|NCT04178590|144531539|SUPERIORITY|||||||0||||||p\<0.05|Wilcoxon (Mann-Whitney)|||||||0.000
72500648|NCT04178590|144531540|SUPERIORITY|||||||0||||||p\<0.05|Wilcoxon (Mann-Whitney)|||||||0.000
72500649|NCT04178590|144531541|SUPERIORITY|||||||0||||||p\<0.05|Wilcoxon (Mann-Whitney)|||||||0.000
72500650|NCT04178590|144531542|SUPERIORITY|||||||0||||||p\<0.05|Wilcoxon (Mann-Whitney)|||||||0.000
72500651|NCT04178590|144531543|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||||||0.000
72500652|NCT04178590|144531544|SUPERIORITY|||||||0.671||||||p\<0.05|Wilcoxon (Mann-Whitney)|||||||0.671
72500653|NCT04178590|144531545|SUPERIORITY|||||||0||||||p\<0.05|Wilcoxon (Mann-Whitney)|||||||0.000
72500654|NCT04178590|144531546|SUPERIORITY|||||||0||||||p\<0.05|Wilcoxon (Mann-Whitney)|||||||0.000
72500655|NCT04178590|144531547|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||||||0.000
72500656|NCT04178590|144531548|SUPERIORITY|||||||0.753||||||p\<0.05|Wilcoxon (Mann-Whitney)|||||||0.753
72458756|NCT00264576|144439893|NON_INFERIORITY_OR_EQUIVALENCE|To demonstrate non-inferiority of cTIV to eTIV\_f the lower limit of the 95% confidence interval (CI) around the ratio of the postvaccination geometric mean titers (GMTs) had to be \>0.5.|Ratio of GMT|0.61|||||TWO_SIDED|95.0|0.5|0.75|||ANOVA|||"The following hypotheses were tested for A/H3N2 strain as measured by HI cell-culture-derived assay:~H0i: log(GMTeTIV\_f(i)) - log(GMTcTIV(i)) ≥0.301 ↔ GMTcTIV(i) / GMTeTIV\_f(i) ≤0.5 (null hypothesis); H1i: log(GMTeTIV\_f(i)) - log(GMTcTIV(i)) \<0.301 ↔ GMTcTIV(i) / GMTeTIV\_f(i) \>0.5 (alternative hypothesis); With: GMTcTIV(i)=GMT for strain i in cTIV group; GMTeTIV\_f(i)=GMT for strain i in eTIV\_f group."||0.75|0.50|
72458757|NCT00264576|144439893|NON_INFERIORITY_OR_EQUIVALENCE|To demonstrate non-inferiority of cTIV to eTIV\_f the lower limit of the 95% confidence interval (CI) around the ratio of the postvaccination geometric mean titers (GMTs) had to be \>0.5.|Ratio of GMT|1.31|||||TWO_SIDED|95.0|1.09|1.57|||ANOVA|||"The following hypotheses were tested for B strain as measured by cell-culture-derived assay:~H0i: log(GMTeTIV\_f(i)) - log(GMTcTIV(i)) ≥0.301 ↔ GMTcTIV(i) / GMTeTIV\_f(i) ≤0.5 (null hypothesis); H1i: log(GMTeTIV\_f(i)) - log(GMTcTIV(i)) \<0.301 ↔ GMTcTIV(i) / GMTeTIV\_f(i) \>0.5 (alternative hypothesis); With: GMTcTIV(i)=GMT for strain i in cTIV group; GMTeTIV\_f(i)=GMT for strain i in eTIV\_f group."||1.57|1.09|
72458758|NCT00264576|144439899|NON_INFERIORITY_OR_EQUIVALENCE|To demonstrate non-inferiority of cTIV to eTIV\_f the lower limit of the 95% confidence interval (CI) around the ratio of the postvaccination GMTs had to be \>0.5.|Ratio of GMT|0.85|||||TWO_SIDED|95.0|0.7|1.03|||ANCOVA|||"The following hypotheses were tested for A/H1N1 strain as measured by HI egg-derived assay:~H0i: log(GMTeTIV\_f(i)) - log(GMTcTIV(i)) ≥0.301 ↔ GMTcTIV(i) / GMTeTIV\_f(i) ≤0.5 (null hypothesis); H1i: log(GMTeTIV\_f(i)) - log(GMTcTIV(i)) \<0.301 ↔ GMTcTIV(i) / GMTeTIV\_f(i) \>0.5 (alternative hypothesis); With: GMTcTIV(i)=GMT for strain i in cTIV group; GMTeTIV\_f(i)=GMT for strain i in eTIV\_f group."||1.03|0.70|
72458759|NCT00264576|144439899|NON_INFERIORITY_OR_EQUIVALENCE|To demonstrate non-inferiority of cTIV to eTIV\_f the lower limit of the 95% confidence interval (CI) around the ratio of the postvaccination GMTs had to be \>0.5.|Ratio of GMT|0.63|||||TWO_SIDED|95.0|0.52|0.76|||ANCOVA|||"The following hypotheses were tested for A/H3N2 strain as measured by HI egg-derived assay:~H0i: log(GMTeTIV\_f(i)) - log(GMTcTIV(i)) ≥0.301 ↔ GMTcTIV(i) / GMTeTIV\_f(i) ≤0.5 (null hypothesis); H1i: log(GMTeTIV\_f(i)) - log(GMTcTIV(i)) \<0.301 ↔ GMTcTIV(i) / GMTeTIV\_f(i) \>0.5 (alternative hypothesis); With: GMTcTIV(i)=GMT for strain i in cTIV group; GMTeTIV\_f(i)=GMT for strain i in eTIV\_f group."||0.76|0.52|
72458760|NCT00264576|144439899|NON_INFERIORITY_OR_EQUIVALENCE|To demonstrate non-inferiority of cTIV to eTIV\_f the lower limit of the 95% confidence interval (CI) around the ratio of the postvaccination GMTs had to be \>0.5.|Ratio of GMT|1.16|||||TWO_SIDED|95.0|0.98|1.38|||ANCOVA|||"The following hypotheses were tested for B strain as measured by HI egg-derived assay:~H0i: log(GMTeTIV\_f(i)) - log(GMTcTIV(i)) ≥0.301 ↔ GMTcTIV(i) / GMTeTIV\_f(i) ≤0.5 (null hypothesis); H1i: log(GMTeTIV\_f(i)) - log(GMTcTIV(i)) \<0.301 ↔ GMTcTIV(i) / GMTeTIV\_f(i) \>0.5 (alternative hypothesis); With: GMTcTIV(i)=GMT for strain i in cTIV group; GMTeTIV\_f(i)=GMT for strain i in eTIV\_f group."||1.38|0.98|
72458761|NCT00264576|144439899|NON_INFERIORITY_OR_EQUIVALENCE|To demonstrate non-inferiority of cTIV to eTIV\_f the lower limit of the 95% confidence interval (CI) around the ratio of the postvaccination GMTs had to be \>0.5.|Ratio of GMT|0.92|||||TWO_SIDED|95.0|0.76|1.12||To demonstrate non-inferiority of cTIV to eTIV\_f the lower limit of the 95% confidence interval (CI) around the ratio of the postvaccination GMTs had to be \>0.5.|ANCOVA|||"The following hypotheses were tested for A/H1N1 strain as measured by HI cell-culture-derived assay:~H0i: log(GMTeTIV\_f(i)) - log(GMTcTIV(i)) ≥0.301 ↔ GMTcTIV(i) / GMTeTIV\_f(i) ≤0.5 (null hypothesis); H1i: log(GMTeTIV\_f(i)) - log(GMTcTIV(i)) \<0.301 ↔ GMTcTIV(i) / GMTeTIV\_f(i) \>0.5 (alternative hypothesis); With: GMTcTIV(i)=GMT for strain i in cTIV group; GMTeTIV\_f(i)=GMT for strain i in eTIV\_f group."||1.12|0.76|
72458762|NCT00264576|144439899|NON_INFERIORITY_OR_EQUIVALENCE|To demonstrate non-inferiority of cTIV to eTIV\_f the lower limit of the 95% confidence interval (CI) around the ratio of the postvaccination GMTs had to be \>0.5.|Ratio of GMT|0.69|||||TWO_SIDED|95.0|0.57|0.83|||ANCOVA|||"The following hypotheses were tested for A/H3N2 strain as measured by HI cell-culture-derived assay:~H0i: log(GMTeTIV\_f(i)) - log(GMTcTIV(i)) ≥0.301 ↔ GMTcTIV(i) / GMTeTIV\_f(i) ≤0.5 (null hypothesis); H1i: log(GMTeTIV\_f(i)) - log(GMTcTIV(i)) \<0.301 ↔ GMTcTIV(i) / GMTeTIV\_f(i) \>0.5 (alternative hypothesis); With: GMTcTIV(i)=GMT for strain i in cTIV group; GMTeTIV\_f(i)=GMT for strain i in eTIV\_f group."||0.83|0.57|
72458763|NCT00264576|144439899|NON_INFERIORITY_OR_EQUIVALENCE|To demonstrate non-inferiority of cTIV to eTIV\_f the lower limit of the 95% confidence interval (CI) around the ratio of the postvaccination GMTs had to be \>0.5.|Ratio of GMT|1.33|||||TWO_SIDED|95.0|1.13|1.58|||ANCOVA|||"The following hypotheses were tested for B strain as measured by HI cell-culture-derived assay:~H0i: log(GMTeTIV\_f(i)) - log(GMTcTIV(i)) ≥0.301 ↔ GMTcTIV(i) / GMTeTIV\_f(i) ≤0.5 (null hypothesis); H1i: log(GMTeTIV\_f(i)) - log(GMTcTIV(i)) \<0.301 ↔ GMTcTIV(i) / GMTeTIV\_f(i) \>0.5 (alternative hypothesis); With: GMTcTIV(i)=GMT for strain i in cTIV group; GMTeTIV\_f(i)=GMT for strain i in eTIV\_f group."||1.58|1.13|
72458764|NCT02834624|144439944|OTHER||||||<|0.05|||||||t-test, 1 sided|||Sample size calculations used a Chi-square for independence, u = 1, p =.05, power = .80, effect size = .60, which required 22 total subjects.||||<.05
72458765|NCT02834624|144439946|OTHER|||||||0.63|||||||t-test, 1 sided|||||||0.63
72458766|NCT00092456|144439947|NON_INFERIORITY_OR_EQUIVALENCE|If equivalence was established in all 3 pairwise comparisons for a given serotype, the 3 lots were considered consistent for that serotype. Each comparison consisted of 2 one-sided tests of equivalence with α=0.05. Statistical significance for the 2 one-sided equivalence tests for each pair of lots was established if the p-values for the hypothesis tests were each less than 0.05. This corresponds to the 2-sided 90% CI for the fold difference in the 2 lots being contained entirely within (0.5,2).|||||<|0.001||95.0||||The reported p-value is for all 5 serotypes, no multiplicity adjustment made, and Type I error rate controlled at the 0.05 level. P\<0.05 implies that the difference is statistically significantly less than the prespecified difference of 2 fold.|ANOVA|||A pairwise comparison of lots was made for each serotype, for each pair of lots.||||<0.001
72470046|NCT05131477|144464326|SUPERIORITY||Proportion Difference|0.18||||0.0046|TWO_SIDED|95.0|0.06|0.3|||Cochran-Mantel-Haenszel|||Week 24||0.3|0.06|0.0046
72470047|NCT05131477|144464327|SUPERIORITY||Proportion Difference|0.19||||0.0006|TWO_SIDED|95.0|0.09|0.3|||Cochran-Mantel-Haenszel|||Week 16||0.3|0.09|0.0006
72470048|NCT05131477|144464327|SUPERIORITY||Proportion Difference|0.14||||0.0057|TWO_SIDED|95.0|0.04|0.24|||Cochran-Mantel-Haenszel|||Week 16||0.24|0.04|0.0057
72500657|NCT04178590|144531549|SUPERIORITY|||||||0||||||p\<0.05|Wilcoxon (Mann-Whitney)|||||||0.000
72458767|NCT00092456|144439947|NON_INFERIORITY_OR_EQUIVALENCE|If equivalence was established in all 3 pairwise comparisons for a given serotype, the 3 lots were considered consistent for that serotype. Each comparison consisted of 2 one-sided tests of equivalence with α=0.05. Statistical significance for the 2 one-sided equivalence tests for each pair of lots was established if the p-values for the hypothesis tests were each less than 0.05. This corresponds to the 2-sided 90% CI for the fold difference in the 2 lots being contained entirely within (0.5,2)|||||<|0.001||95.0||||The reported p-value is for all 5 serotypes, no multiplicity adjustment made, and Type I error rate controlled at the 0.05 level. P\<0.05 implies that the difference is statistically significantly less than the prespecified difference of 2 fold.|ANOVA|||A pairwise comparison of lots was made for each serotype, for each pair of lots.||||<0.001
72458768|NCT00092456|144439947|NON_INFERIORITY_OR_EQUIVALENCE|If equivalence was established in all 3 pairwise comparisons for a given serotype, the 3 lots were considered consistent for that serotype. Each comparison consisted of 2 one-sided tests of equivalence with α=0.05. Statistical significance for the 2 one-sided equivalence tests for each pair of lots was established if the p-values for the hypothesis tests were each less than 0.05. This corresponds to the 2-sided 90% CI for the fold difference in the 2 lots being contained entirely within (0.5,2).|||||<|0.001||95.0||||The reported p-value is for all 5 serotypes, no multiplicity adjustment made, and Type I error rate controlled at the 0.05 level. P\<0.05 implies that the difference is statistically significantly less than the prespecified difference of 2 fold.|ANCOVA|||A pairwise comparison of lots was made for each serotype, for each pair of lots.||||<0.001
72458769|NCT05066230|144439994|SUPERIORITY||Difference of weighted percentages|39.7|||<|0.0001|TWO_SIDED|95.02|31.3|48.1|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haentzel test stratified by baseline DRSS level (≤level 47 vs. ≥level 53) and HbA1c level (≤8.5% vs. \>8.5%).|Weighted percentages are based on weighted average of observed estimates across strata using CMH weights. The CI are based on the normal approximation to the binomial proportions.|||48.1|31.3|<0.0001
72458770|NCT05066230|144439995|SUPERIORITY||Difference of weighted percentages|-18.7|||<|0.0001|TWO_SIDED|95.02|-26.2|-11.2|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haentzel test stratified by baseline DRSS level (≤level 47 vs. ≥level 53) and HbA1c level (≤8.5% vs. \>8.5%).|Weighted percentages are based on weighted average of observed estimates across strata using CMH weights. The CI are based on the normal approximation to the binomial proportions.|||-11.2|-26.2|<0.0001
72458771|NCT05066230|144439996|SUPERIORITY||Difference of weighted percentages|5.6||||0.0058|TWO_SIDED|95.02|1.6|9.5|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haentzel test stratified by baseline DRSS level (≤level 47 vs. ≥level 53), HbA1c level (≤8.5% vs. \>8.5%).|Weighted percentages are based on weighted average of observed estimates across strata using CMH weights. The CI are based on the normal approximation to the binomial proportions.|||9.5|1.6|0.0058
72458772|NCT05066230|144439997|SUPERIORITY||Difference of weighted percentages|-6.5||||0.0149|TWO_SIDED|95.02|-11.8|-1.3|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haentzel test stratified by baseline DRSS level (≤level 47 vs. ≥level 53) and HbA1c level (≤8.5% vs. \>8.5%).|Weighted percentages are based on weighted average of observed estimates across strata using CMH weights. The CI are based on the normal approximation to the binomial proportions.|||-1.3|-11.8|0.0149
72458773|NCT03072238|144440009|SUPERIORITY||Hazard Ratio (HR)|0.77||||0.0335|TWO_SIDED|95.0|0.61|0.98|||Log Rank|||||0.98|0.61|0.0335
72458774|NCT03072238|144440010|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.0431|TWO_SIDED|95.0|0.71|0.99|||Log Rank|||||0.99|0.71|0.0431
72458775|NCT03072238|144440011|SUPERIORITY||Hazard Ratio (HR)|0.94||||0.5698|TWO_SIDED|95.0|0.76|1.17|||Log Rank|||||1.17|0.76|0.5698
72620896|NCT00452400|144772828|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.171|STANDARD_ERROR_OF_MEAN|0.044||0.0001||95.0|0.084|0.258|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 20 mcg qd minus Placebo|||0.258|0.084|0.0001
72620897|NCT00452400|144772829|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.09|STANDARD_ERROR_OF_MEAN|0.052||0.0836||95.0|-0.012|0.192|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 2 mcg qd minus Placebo|||0.192|-0.012|0.0836
72458776|NCT03072238|144440012|SUPERIORITY||Hazard Ratio (HR)|0.91||||0.2515|TWO_SIDED|95.0|0.79|1.07|||Log Rank|||||1.07|0.79|0.2515
72458777|NCT03072238|144440013|SUPERIORITY||Hazard Ratio (HR)|0.76||||0.601|TWO_SIDED|95.0|0.58|1.01|||Log Rank|||||1.01|0.58|0.6010
72458778|NCT03072238|144440014|SUPERIORITY||Hazard Ratio (HR)|0.87||||0.1723|TWO_SIDED|95.0|0.72|1.06|||Log Rank|||||1.06|0.72|0.1723
72458779|NCT03072238|144440015|SUPERIORITY||Hazard Ratio (HR)|0.83||||0.1566|TWO_SIDED|95.0|0.65|1.07|||Log Rank|||||1.07|0.65|0.1566
72458780|NCT03072238|144440016|SUPERIORITY||Hazard Ratio (HR)|0.83||||0.0419|TWO_SIDED|95.0|0.69|0.99|||Log Rank|||||0.99|0.69|0.0419
72458781|NCT03072238|144440017|SUPERIORITY||Hazard Ratio (HR)|1.13||||0.3198|TWO_SIDED|95.0|0.89|1.45|||Log Rank|||||1.45|0.89|0.3198
72458782|NCT03072238|144440018|SUPERIORITY||Hazard Ratio (HR)|1.25||||0.0071|TWO_SIDED|95.0|1.06|1.47|||Log Rank|||||1.47|1.06|0.0071
72500658|NCT04178590|144531550|SUPERIORITY|||||||0||||||p\<0.05|Wilcoxon (Mann-Whitney)|||||||0.000
72458783|NCT03072238|144440019|SUPERIORITY||Hazard Ratio (HR)|0.73||||0.0045|TWO_SIDED|95.0|0.59|0.91|||Log Rank|||||0.91|0.59|0.0045
72458784|NCT03072238|144440020|SUPERIORITY||Hazard Ratio (HR)|0.71|||<|0.0001|TWO_SIDED|95.0|0.61|0.83|||Log Rank|||||0.83|0.61|< 0.0001
72458785|NCT03072238|144440021|SUPERIORITY||Hazard Ratio (HR)|0.79||||0.1359|TWO_SIDED|95.0|0.57|1.08|||Log Rank|||||1.08|0.57|0.1359
72458786|NCT03072238|144440022|SUPERIORITY||Hazard Ratio (HR)|0.85||||0.1398|TWO_SIDED|95.0|0.68|1.06|||Log Rank|||||1.06|0.68|0.1398
72458787|NCT03072238|144440023|SUPERIORITY||Hazard Ratio (HR)|0.95||||0.8239|TWO_SIDED|95.0|0.61|1.48|||Log Rank|||||1.48|0.61|0.8239
72458788|NCT03072238|144440024|SUPERIORITY||Hazard Ratio (HR)|0.92||||0.6018|TWO_SIDED|95.0|0.66|1.27|||Log Rank|||||1.27|0.66|0.6018
72500659|NCT04178590|144531551|SUPERIORITY|||||||0||||||p\<0.05|Wilcoxon (Mann-Whitney)|||||||0.000
72500660|NCT00310310|144531589|SUPERIORITY_OR_OTHER|||||||0.001|||||||t-test, 1 sided|||||||0.001
72500661|NCT00310310|144531590|SUPERIORITY_OR_OTHER|||||||0.023|||||||t-test, 1 sided|||||||0.023
72500662|NCT00310310|144531591|SUPERIORITY_OR_OTHER|||||||0.8|||||||t-test, 1 sided|||||||0.8
72500663|NCT00310310|144531593|SUPERIORITY_OR_OTHER|||||||0.96|||||||t-test, 1 sided|||||||0.96
72563047|NCT02093923|144658126|SUPERIORITY||Percent Change in Mean Rate|-87.02|||<|0.0001|TWO_SIDED|95.0|-94.55|-69.06|||Mixed Models Analysis|||The result was based on General Estimating Equation (GEE) analysis. Generalized Estimating Equation (GEE) approach with Poisson distribution assumption was applied to the repeated-measures mixed model with independence working correlation structure. The treatment group was a fixed effect and the number of baseline HAE attacks per week was included as a covariate in the GEE.||-69.06|-94.55|<.0001
72458789|NCT03072238|144440025|SUPERIORITY||Difference in Overall Response Rate|20.93||||0.003|TWO_SIDED|95.0|6.2|35.65|||Cochran-Mantel-Haenszel|||||35.65|6.20|0.0030
72458790|NCT03072238|144440026|SUPERIORITY||Difference in Overall Response Rate|16.46||||0.0008|TWO_SIDED|95.0|6.66|26.27|||Cochran-Mantel-Haenszel|||||26.27|6.66|0.0008
72458791|NCT03072238|144440029|SUPERIORITY||Difference in Overall Response Rate|11.81||||0.0012|TWO_SIDED|95.0|4.34|19.29|||Cochran-Mantel-Haenszel|||||19.29|4.34|0.0012
72458792|NCT03072238|144440030|SUPERIORITY||Difference in Overall Response Rate|5.87||||0.0178|TWO_SIDED|95.0|0.83|10.9|||Cochran-Mantel-Haenszel|||||10.90|0.83|0.0178
72458793|NCT03072238|144440031|SUPERIORITY||Hazard Ratio (HR)|0.65||||0.0246|TWO_SIDED|95.0|0.45|0.95|||Log Rank|||||0.95|0.45|0.0246
72458794|NCT01301183|144440052|OTHER|ANCOVA||||||0.109||||||Adjusted for baseline age, height, bone density and 12-month weight change|ANCOVA|||||||.109
72458795|NCT01301183|144440053|OTHER|||||||0.344||||||Adjusted for age, height, baseline trabecular number and change in weight over 12 months|ANCOVA|||||||0.344
72458796|NCT01072149|144440054|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.233|||<|0.001|TWO_SIDED|95.0|0.179|0.287|||Mixed Models Analysis|||||0.287|0.179|<0.001
72458797|NCT01072149|144440054|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.22|||<|0.001|TWO_SIDED|95.0|0.165|0.275|||Mixed Models Analysis|||||0.275|0.165|<0.001
72458798|NCT01072149|144440054|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.236|||<|0.001|TWO_SIDED|95.0|0.181|0.291|||Mixed Models Analysis|||||0.291|0.181|<0.001
72458799|NCT00080119|144440058|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.98||||0.93|TWO_SIDED|95.0|0.67|1.44||Threshold p-value for significance = 0.0492|Log Rank||Hazard ratio for INH relative to Placebo|||1.44|0.67|0.93
72458800|NCT00080119|144440059|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.85||||0.43|TWO_SIDED|95.0|0.55|1.3||Threshold p-value for significance = 0.0493|Log Rank||Hazard ratio for INH relative to Placebo|||1.30|0.55|0.43
72458801|NCT03875729|144440101|SUPERIORITY||Mean Difference (Net)|0.1253|||<|0.001|TWO_SIDED|95.0|0.0852|0.1653||ITT: The ANCOVA model included treatment, age group at randomization, and baseline C-peptide ln(AUC+1) as independent variables. Missing data at Week 78 were multiply imputed using pattern-mixture model under the missing not at random assumption.|ANCOVA||Least squares mean (LSmean) difference = Teplizumab - Placebo|This study was designed to show a difference of at least a 40% in C-peptide response between teplizumab and placebo. In geometric means, this translates to a value of (1.4×0.28) = 0.392. Consequently, approximately 300 participants were planned for enrollment, assuming 2-sided α=0.05, 90% power, 2:1 randomization, and a 10% dropout rate.||0.1653|0.0852|<0.001
72458802|NCT03875729|144440101|SUPERIORITY||Mean Difference (Net)|0.1385|||<|0.001|TWO_SIDED|95.0|0.0994|0.1776||PP: The ANCOVA model included treatment, age group at randomization, and baseline C-peptide ln(AUC+1) as independent variables. Missing data at Week 78 were multiply imputed using a pattern-mixture model under the missing not at random assumption.|ANCOVA||Least squares mean (LSmean) difference = teplizumab - placebo|||0.1776|0.0994|<0.001
72458803|NCT03875729|144440102|SUPERIORITY||Mean Difference (Final Values)|-0.131||||0.085|TWO_SIDED|95.0|-0.28|0.018||ITT: ANCOVA model included treatment, age group at randomization, and screening peak C-peptide category as independent variables. Missing data at Week 78 were multiply imputed using a pattern-mixture model under the missing not at random assumption.|ANCOVA||LSmean difference = teplizumab - placebo.|||0.018|-0.280|0.085
72458804|NCT03875729|144440102|SUPERIORITY||Mean Difference (Final Values)|-0.167|||<|0.001|TWO_SIDED|95.0|-0.256|-0.078||PP: ANCOVA model included treatment, age group at randomization, and screening peak C-peptide category as independent variables. Missing data at Week 78 were multiply imputed using a pattern-mixture model under the missing not at random assumption.|ANCOVA||LSmean difference = teplizumab - placebo.|||-0.078|-0.256|<0.001
72458805|NCT03875729|144440103|SUPERIORITY||Mean Difference (Final Values)|-0.09||||0.606|TWO_SIDED|95.0|-0.42|0.24||ITT: ANCOVA model included treatment, age group at randomization, screening peak C-peptide category, baseline HbA1c as independent variables. Missing data were multiply imputed using a pattern-mixture model under the missing not at random assumption.|ANCOVA|||||0.24|-0.42|0.606
72458806|NCT03875729|144440103|SUPERIORITY||Mean Difference (Final Values)|-0.13||||0.454|TWO_SIDED|95.0|-0.46|0.2||PP: ANOVA model included treatment, age group at randomization, screening peak C-peptide category, baseline HbA1c as independent variables. Missing data were multiply imputed using a pattern-mixture model under the missing not at random assumption.|ANCOVA||LSmean difference = teplizumab - placebo.|||0.20|-0.46|0.454
72563048|NCT02093923|144658127|SUPERIORITY||Percent Change in Mean Rate|-100.0|||<|0.0001|TWO_SIDED|95.0|-100.0|-100.0|||Mixed Models Analysis|||The result was based on General Estimating Equation (GEE) analysis. Generalized Estimating Equation (GEE) approach with Poisson distribution assumption was applied to the repeated-measures mixed model with independence working correlation structure. The treatment group was a fixed effect and the number of baseline HAE attacks per week was included as a covariate in the GEE.||-100.00|-100.00|<.0001
72458807|NCT03875729|144440104|SUPERIORITY||Mean Difference (Final Values)|4.71||||0.151|TWO_SIDED|95.0|-1.72|11.15||ITT: The ANCOVA model included treatment, age group at randomization, and screening peak C-peptide category as independent variables. Missing data were multiply imputed using a pattern-mixture model under the missing not at random assumption.|ANCOVA||LSmean difference = teplizumab - placebo.|||11.15|-1.72|0.151
72458808|NCT03875729|144440104|SUPERIORITY||Mean Difference (Final Values)|6.17||||0.045|TWO_SIDED|95.0|0.13|12.22||PP: The ANCOVA model included treatment, age group at randomization, and screening peak C-peptide category as independent variables. Missing data were multiply imputed using a pattern-mixture model under the missing not at random assumption.|ANCOVA||LSmean difference = teplizumab - placebo.|||12.22|0.13|0.045
72470049|NCT05131477|144464327|SUPERIORITY||Proportion Difference|0.16||||0.0038|TWO_SIDED|95.0|0.05|0.26|||Cochran-Mantel-Haenszel|||Week 16||0.26|0.05|0.0038
72470050|NCT05131477|144464327|SUPERIORITY||Proportion Difference|0.18||||0.0011|TWO_SIDED|95.0|0.07|0.28|||Cochran-Mantel-Haenszel|||Week 16||0.28|0.07|0.0011
72458809|NCT03875729|144440105|SUPERIORITY||Rate ratio|1.1||||0.634|TWO_SIDED|95.0|0.74|1.64||ITT: Estimates and p-values were obtained from a negative binomial regression model using rate of hypoglycemic episodes as dependent variable and treatment, age group at randomization, and screening peak C-peptide category as independent variables.|Negative binomial regression model||Rate ratio = teplizumab / placebo.|||1.64|0.74|0.634
72458810|NCT03875729|144440105|SUPERIORITY||Rate ratio|1.09||||0.69|TWO_SIDED|95.0|0.72|1.65||PP: Estimates and p-values were obtained from a negative binomial regression model using rate of hypoglycemic episodes as dependent variable and treatment age group at randomization, and screening peak C-peptide category as independent variables.|Rate ratio||Rate ratio = teplizumab / placebo.|||1.65|0.72|0.690
72458811|NCT02159352|144440119|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio|0.384|||||TWO_SIDED|90.0|0.348|0.423||||||A general linear mixed effect model (restricted maximum likelihood) with treatment as fixed effect and measurements within each participant as repeated measures was fitted to the log-transformed Cmax.||0.423|0.348|
72458812|NCT02159352|144440119|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio|0.337|||||TWO_SIDED|90.0|0.306|0.371||||||A general linear mixed effect model (restricted maximum likelihood) with treatment as fixed effect and measurements within each participant as repeated measures was fitted to the log-transformed Cmax.||0.371|0.306|
72458813|NCT02159352|144440120|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio|0.703|||||TWO_SIDED|90.0|0.658|0.75||||||A general linear mixed effect model (restricted maximum likelihood) with treatment as fixed effect and measurements within each participant as repeated measures was fitted to the log-transformed AUC(TAU).||0.750|0.658|
72458814|NCT02159352|144440120|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio|0.577|||||TWO_SIDED|90.0|0.535|0.622||||||A general linear mixed effect model (restricted maximum likelihood) with treatment as fixed effect and measurements within each participant as repeated measures was fitted to the log-transformed AUC(TAU).||0.622|0.535|
72458815|NCT02159352|144440123|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio|0.768|||||TWO_SIDED|90.0|0.697|0.846||||||A general linear mixed effect model (restricted maximum likelihood) with treatment as fixed effect and measurements within each participant as repeated measures was fitted to the log-transformed Cmax/D.||0.846|0.697|
72458816|NCT02159352|144440123|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio|0.673|||||TWO_SIDED|90.0|0.611|0.742||||||A general linear mixed effect model (restricted maximum likelihood) with treatment as fixed effect and measurements within each participant as repeated measures was fitted to the log-transformed Cmax/D.||0.742|0.611|
72470051|NCT05131477|144464327|SUPERIORITY||Proportion Difference|0.23||||0.0002|TWO_SIDED|95.0|0.11|0.35|||Cochran-Mantel-Haenszel|||Week 24||0.35|0.11|0.0002
72500664|NCT00310310|144531594|SUPERIORITY_OR_OTHER|||||||0.59|||||||t-test, 1 sided|||||||0.59
72500665|NCT00310310|144531595|SUPERIORITY_OR_OTHER|||||||0|||||||t-test, 1 sided|||||||0.00
72500666|NCT00310310|144531596|SUPERIORITY_OR_OTHER|||||||0.02|||||||t-test, 1 sided|||||||0.02
72620898|NCT00452400|144772829|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.171|STANDARD_ERROR_OF_MEAN|0.052||0.0011||95.0|0.068|0.274|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 5 mcg qd minus Placebo|||0.274|0.068|0.0011
72620899|NCT00452400|144772829|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.15|STANDARD_ERROR_OF_MEAN|0.051||0.0037||95.0|0.049|0.25|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 10 mcg qd minus Placebo|||0.250|0.049|0.0037
72620900|NCT00452400|144772829|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.148|STANDARD_ERROR_OF_MEAN|0.052||0.0047||95.0|0.046|0.251|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 20 mcg qd minus Placebo|||0.251|0.046|0.0047
72500667|NCT00310310|144531597|SUPERIORITY_OR_OTHER|||||||0.08|||||||t-test, 1 sided|||||||0.08
72620901|NCT00452400|144772830|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.094|STANDARD_ERROR_OF_MEAN|0.051||0.0695||95.0|-0.008|0.195|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 2 mcg qd minus Placebo|||0.195|-0.008|0.0695
72620902|NCT00452400|144772830|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.162|STANDARD_ERROR_OF_MEAN|0.052||0.0018||95.0|0.061|0.264|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 5 mcg qd minus Placebo|||0.264|0.061|0.0018
72470052|NCT05131477|144464327|SUPERIORITY||Proportion Difference|0.17||||0.0038|TWO_SIDED|95.0|0.06|0.28|||Cochran-Mantel-Haenszel|||Week 24||0.28|0.06|0.0038
72470053|NCT05131477|144464327|SUPERIORITY||Proportion Difference|0.21||||0.0006|TWO_SIDED|95.0|0.09|0.32|||Cochran-Mantel-Haenszel|||Week 24||0.32|0.09|0.0006
72470054|NCT05131477|144464327|SUPERIORITY||Proportion Difference|20.0||||0.0008|TWO_SIDED|95.0|9.0|32.0|||Cochran-Mantel-Haenszel|||Week 24||32|9|0.0008
72470055|NCT05101993|144464388|SUPERIORITY||||||<|0.0001|||||||Chi-squared|||||||<0.0001
72470056|NCT01124838|144464398|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.57||||0.004|TWO_SIDED|95.0|0.39|0.84|||Log Rank|||The primary analysis of the primary endpoint was performed on Main Study data, excluding the Japanese sub-study. The statistical test was performed at a 2-sided significance level of 0.05. The hazard ratio of adalimumab versus placebo was calculated using proportional hazards regression with treatment as factor.||0.84|0.39|0.004
72470057|NCT01124838|144464398|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.52|||<|0.001|TWO_SIDED|95.0|0.37|0.74|||Log Rank|||An additional analysis of the primary endpoint was performed using the Integrated Study data (Main Study + Japan sub-study). The statistical test was performed at a 2-sided significance level of 0.05. The hazard ratio of adalimumab versus placebo was calculated using proportional hazards regression with treatment and race (Japanese versus non-Japanese) as factors.||0.74|0.37|<0.001
72470058|NCT01124838|144464399|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference|-0.14||||0.218|TWO_SIDED|95.0|-0.37|0.08|||ANOVA|From ANOVA with treatment as factor adjusted for clustered observations (i.e., observations from each of the participant's eyes).|The mean difference between treatment groups with its 95% confidence interval is based on individual data from all eyes adjusted for correlated measurements within a subject in an analysis of variance (ANOVA) model.|The statistical test for the ranked secondary variables was carried out in hierarchical order at the significance level of 5%.||0.08|-0.37|0.218
72500668|NCT00310310|144531598|SUPERIORITY_OR_OTHER|||||||0.38|||||||t-test, 1 sided|||||||0.38
72458817|NCT02159352|144440124|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio|1.406|||||TWO_SIDED|90.0|1.317|1.501||||||A general linear mixed effect model (restricted maximum likelihood) with treatment as fixed effect and measurements within each participant as repeated measures was fitted to the log-transformed (AUC(TAU)/D).||1.501|1.317|
72458818|NCT02159352|144440124|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio|1.154|||||TWO_SIDED|90.0|1.07|1.244||||||A general linear mixed effect model (restricted maximum likelihood) with treatment as fixed effect and measurements within each participant as repeated measures was fitted to the log-transformed (AUC(TAU)/D).||1.244|1.070|
72458819|NCT01214109|144440130|SUPERIORITY_OR_OTHER||Ratio of geometric least squares means|82.62||||||90.0|74.45|91.69|||ANOVA|||0.125 mg t.i.d. IR is the reference treatment, 0.375 mg q.d. ER is the test treatment||91.69|74.45|
72500669|NCT00363415|144531599|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.56|||<|0.01||95.0|1.27|1.92|||Log Rank|||||1.92|1.27|<0.01
72500670|NCT00363415|144531600|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Sex: Male|Log Rank|||||||<0.001
72458820|NCT01214109|144440130|SUPERIORITY_OR_OTHER||Ratio of geometric least squares means|96.17||||||90.0|69.33|133.42|||ANOVA|||0.5 mg t.i.d. IR is the reference treatment, 1.5 mg q.d. ER is the test treatment||133.42|69.33|
72458821|NCT01214109|144440131|SUPERIORITY_OR_OTHER||Ratio of geometric least squares means|88.01||||||90.0|80.76|95.92|||ANOVA|||0.125 mg t.i.d. IR vs. 0.375 mg q.d. ER 0.125 mg t.i.d. IR is the reference treatment, 0.375 mg q.d. ER is the test treatment||95.92|80.76|
72458822|NCT01214109|144440131|SUPERIORITY_OR_OTHER||Ratio of geometric least squares means|89.37||||||90.0|81.16|98.42|||ANOVA|||0.5 mg t.i.d. IR vs. 1.5 mg q.d. ER 0.5 mg t.i.d. IR is the reference treatment, 1.5 mg q.d. ER is the test treatment||98.42|81.16|
72458823|NCT01214109|144440132|SUPERIORITY_OR_OTHER||Ratio of geometric least squares means|88.82||||||90.0|79.89|98.76|||ANOVA|||0.125 mg t.i.d. IR vs. 0.375 mg q.d. ER 0.125 mg t.i.d. IR is the reference treatment, 0.375 mg q.d. ER is the test treatment||98.76|79.89|
72500671|NCT00363415|144531600|SUPERIORITY_OR_OTHER|||||||0.023||95.0||||P-value for Sex: Female|Log Rank|||||||0.023
72620903|NCT00452400|144772830|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.172|STANDARD_ERROR_OF_MEAN|0.051||0.0008||95.0|0.072|0.272|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 10 mcg qd minus Placebo|||0.272|0.072|0.0008
72620904|NCT00452400|144772830|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.179|STANDARD_ERROR_OF_MEAN|0.052||0.0006||95.0|0.077|0.281|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 20 mcg qd minus Placebo|||0.281|0.077|0.0006
72458824|NCT01214109|144440132|SUPERIORITY_OR_OTHER||Ratio of geometric least squares means|91.97||||||90.0|60.07|140.25|||ANOVA|||0.5 mg t.i.d. IR vs. 1.5 mg q.d. ER 0.5 mg t.i.d. IR is the reference treatment, 1.5 mg q.d. ER is the test treatment||140.25|60.07|
72458825|NCT01214109|144440133|SUPERIORITY_OR_OTHER||Ratio of geometric least squares means|92.84||||||90.0|83.8|102.86|||ANOVA|||0.125 mg t.i.d. IR is the reference treatment, 0.375 mg q.d. ER is the test treatment||102.86|83.8|
72458826|NCT01214109|144440133|SUPERIORITY_OR_OTHER||Ratio of geometric least squares means|95.05||||||90.0|84.88|106.43|||ANOVA|||0.5 mg t.i.d. IR is the reference treatment, 1.5 mg q.d. ER is the test treatment||106.43|84.88|
72458827|NCT01297595|144440177|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|99.58|||||TWO_SIDED|90.0|91.08|108.87||||||Natural log transformed AUC (0 - ∞) of crizotinib was analyzed using a mixed effect model with sequence, period and treatment as a fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% confidence intervals (CIs) for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. This was an estimation study and there was no formal statistical hypothesis.||108.87|91.08|
72458828|NCT01297595|144440179|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|99.35|||||TWO_SIDED|90.0|90.51|109.07||||||Natural log transformed AUClast of crizotinib was analyzed using a mixed effect model with sequence, period and treatment as a fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. This was an estimation study and there was no formal statistical hypothesis.||109.07|90.51|
72458829|NCT01297595|144440180|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|96.84|||||TWO_SIDED|90.0|88.22|106.32||||||Natural log transformed Cmax of crizotinib was analyzed using a mixed effect model with sequence, period and treatment as a fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. This was an estimation study and there was no formal statistical hypothesis.||106.32|88.22|
72370499|NCT00488683|144251632|SUPERIORITY_OR_OTHER||R-square|0.66||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between memory B cells one month after primary vaccination and hSBA titers one month after booster vaccination for the serogroup W-135||||
72500672|NCT00363415|144531600|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Race: Caucasian.|Log Rank|||||||<0.001
72500673|NCT00363415|144531600|SUPERIORITY_OR_OTHER|||||||0.03||95.0||||P-value for Race: Non-Caucasian.|Log Rank|||||||0.030
72500674|NCT00363415|144531600|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for ECOG (Eastern Cooperative Oncology Group) Performance Status: 0 or 1.|Log Rank|||||||<0.001
72500675|NCT00363415|144531600|SUPERIORITY_OR_OTHER|||||||0.519||95.0||||P-value for ECOG (Eastern Cooperative Oncology Group) Performance Status: 2.|Log Rank|||||||0.519
72500676|NCT00363415|144531600|SUPERIORITY_OR_OTHER|||||||0.084||95.0||||P-value for Region: United States.|Log Rank|||||||0.084
72500677|NCT00363415|144531600|SUPERIORITY_OR_OTHER|||||||0.001||95.0||||P-value for Region: European Union.|Log Rank|||||||0.001
72500678|NCT00363415|144531600|SUPERIORITY_OR_OTHER|||||||0.003||95.0||||P-value for Region: Intercontinental Region.|Log Rank|||||||0.003
72500679|NCT00363415|144531600|SUPERIORITY_OR_OTHER|||||||0.005||95.0||||P-value for LDH (lactate dehydrogenase): \>Upper Limit of Normal.|Log Rank|||||||0.005
72500680|NCT00363415|144531600|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Age: \<=65 years.|Log Rank|||||||<0.001
72500681|NCT00363415|144531600|SUPERIORITY_OR_OTHER|||||||0.013||95.0||||P-value for Age: \>65 years.|Log Rank|||||||0.013
72458830|NCT03015220|144440246|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|1.5||||0.2963|TWO_SIDED|95.0|0.7|3.2||Unadjusted two-sided p-value for the test of no difference from 1.|Regression, Cox||"Oral Semaglutide 3 mg~/Dulaglutide 0.75 mg"|Time to initiation of additional anti-diabetic medication was analysed using a Cox proportional hazards model with treatment and strata as categorical fixed effects and baseline HbA1c as covariate. Withdrawal for any reason or lost to follow-up contributed to the analysis as events (initiation of additional anti-diabetic medication). Censoring time was one day before planned end of treatment.||3.20|0.70|0.2963
72458831|NCT03015220|144440246|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|0.8||||0.5997|TWO_SIDED|95.0|0.35|1.83||Unadjusted two-sided p-value for the test of no difference from 1.|Regression, Cox||"Oral Semaglutide 7 mg~/Dulaglutide 0.75 mg"|Time to initiation of additional anti-diabetic medication was analysed using a Cox proportional hazards model with treatment and strata as categorical fixed effects and baseline HbA1c as covariate. Withdrawal for any reason or lost to follow-up contributed to the analysis as events (initiation of additional anti-diabetic medication). Censoring time was one day before planned end of treatment.||1.83|0.35|0.5997
72458832|NCT03015220|144440246|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|0.55||||0.1871|TWO_SIDED|95.0|0.23|1.33||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox||"Oral Semaglutide 14 mg~/Dulaglutide 0.75 mg"|Time to initiation of additional anti-diabetic medication was analysed using a Cox proportional hazards model with treatment and strata as categorical fixed effects and baseline HbA1c as covariate. Withdrawal for any reason or lost to follow-up contributed to the analysis as events (initiation of additional anti-diabetic medication). Censoring time was one day before planned end of treatment.||1.33|0.23|0.1871
72458833|NCT03015220|144440247|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|1.9||||0.1672|TWO_SIDED|95.0|0.76|4.72||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox||"Oral Semaglutide 3 mg~/Dulaglutide 0.75 mg"|Time to initiation of rescue medication was analysed using a Cox proportional hazards model with treatment and strata as categorical fixed effects and baseline HbA1c as covariate. Censoring time was one day before last day on trial product.||4.72|0.76|0.1672
72458834|NCT03015220|144440247|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|0.6||||0.3391|TWO_SIDED|95.0|0.21|1.72||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox||"Oral Semaglutide 7 mg~/Dulaglutide 0.75 mg"|Time to initiation of rescue medication was analysed using a Cox proportional hazards model with treatment and strata as categorical fixed effects and baseline HbA1c as covariate. Censoring time was one day before last day on trial product.||1.72|0.21|0.3391
72458835|NCT03015220|144440247|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|0.12||||0.011|TWO_SIDED|95.0|0.02|0.62||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox||"Oral Semaglutide 14 mg~/Dulaglutide 0.75 mg"|Time to initiation of rescue medication was analysed using a Cox proportional hazards model with treatment and strata as categorical fixed effects and baseline HbA1c as covariate. Censoring time was one day before last day on trial product.||0.62|0.02|0.0110
72458836|NCT02291549|144440263|SUPERIORITY||Mean Difference (Final Values)|-0.23||||0.0074|TWO_SIDED|95.0|-0.39|-0.06||The 2-sided alpha was 0.05. P-value was not adjusted for multiple comparison.|ANCOVA|Where appropriate, confidence intervals of the difference were constructed using the estimate of the least-squares means||ANCOVA model with site and treatment group as fixed effects and contrasts constructed to estimate the difference between treatment groups. The primary efficacy hypothesis was that the use of the S8 Sinus Implant would reduce the Nasal Obstruction/Congestion score compared to the control group. The null hypothesis was H0: β1=0 and alternative hypothesis was H1: β1 ≠ 0. Only a statistically significant, negative estimate of β1 was to constitute evidence of effectiveness.||-0.06|-0.39|0.0074
72458837|NCT02291549|144440264|SUPERIORITY||Mean Difference (Final Values)|-0.35||||0.0073|TWO_SIDED|95.0|-0.6|-0.09||The 2-sided alpha was 0.05. P-value was not adjusted for multiple comparisons.|ANCOVA|ANCOVA model with site and treatment group as fixed effects and contrasts constructed to estimate the difference between treatment groups.||The between treatment group difference was estimated using the ANCOVA model with site and treatment group as fixed effects. The primary efficacy hypothesis was that the use of the S8 Sinus Implant would reduce the bilateral polyp grade compared to the control group. The null hypothesis was H0: β1=0 and alternative hypothesis was H1: β1 ≠ 0. Only a statistically significant, negative estimate of β1 was to constitute evidence of effectiveness.||-0.09|-0.60|0.0073
72458838|NCT02291549|144440265|SUPERIORITY||Odds Ratio (OR)|2.69||||0.0004|TWO_SIDED|95.0|1.63|4.44||P-value adjusted for multiplicity using the Holm's step-down procedure at a 2-sided significance level of 0.05.|Cochran-Mantel-Haenszel|Adjusted p-value is presented.||Test: H0: OR = 1 vs. OR ≠ 1 by Cochrane-Mantel-Haenszel test||4.44|1.63|0.0004
72458839|NCT02291549|144440266|SUPERIORITY||Mean Difference (Final Values)|-7.96||||0.0007|TWO_SIDED|95.0|-12.1|-3.83||P-value adjusted for multiplicity using the Holm's step-down procedure at a 2-sided significance level of 0.05.|ANCOVA|Adjusted p-value is presented.||ANCOVA model with site and treatment group as fixed effects and contrasts constructed to estimate the difference between treatment groups.The null hypothesis was H0: β1 = 0 and the alternative hypothesis was H1: β1 ≠ 0. Although the alternative hypothesis was specified as 2-sided, only a statistically significant, negative estimate of β1 constituted evidence of effectiveness. The 2-sided alpha for this test was 0.05.||-3.83|-12.10|0.0007
72500682|NCT00363415|144531600|SUPERIORITY_OR_OTHER|||||||0.092||95.0||||P-value for Number Metastatic Sites: \<=2.|Log Rank|||||||0.092
72500683|NCT00363415|144531600|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Number Metastatic Sites: \>=3.|Log Rank|||||||<0.001
72500684|NCT00363415|144531600|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for History of Brain Metastases: No.|Log Rank|||||||<0.001
72500685|NCT03431012|144531706|OTHER||||||>|0.05||||||Sidak corrections were used to adjust for multiple analyses.|ANCOVA|ANCOVAs, setting baseline intentions as a covariate, were performed to determine whether post-exposure mean intentions differed between groups.||We predicted that Virus Agency (VA) and Positive Framing (PF) would lead to greater adherence intentions, compared to the human agency (HA) and negative framing (NF) versions respectively.||||>.05
72500686|NCT03431012|144531707|OTHER||||||=|0.113||||||Sidak corrections were used to adjust for multiple analyses.|MANOVA|||Based on the literature, it was predicted that the Virus Agency would lead to higher worry than the human agency assignment.||||=.113
72458840|NCT02291549|144440267|SUPERIORITY||Mean Difference (Final Values)|-0.27||||0.0248|TWO_SIDED|95.0|-0.48|-0.07||P-value adjusted for multiplicity using the Holm's step-down procedure at a 2-sided significance level of 0.05.|ANCOVA|Adjusted p-value is presented.||ANCOVA model with site and treatment group as fixed effects and contrasts constructed to estimate the difference between treatment groups. The null hypothesis was H0: β1=0 and the alternative hypothesis was H1: β1 ≠ 0. Only a statistically significant, negative estimate of β1 was to constitute evidence of effectiveness.||-0.07|-0.48|0.0248
72458841|NCT02291549|144440268|SUPERIORITY||Mean Difference (Final Values)|-0.46||||0.047|TWO_SIDED|95.0|-0.85|-0.06||P-value adjusted for multiplicity using the Holm's step-down procedure at a 2-sided significance level of 0.05.|ANCOVA|The adjusted p-value is presentenced.||ANCOVA model with site and treatment group as fixed effects and contrasts constructed to estimate the difference between treatment groups. The null hypothesis was H0: β1=0 and alternative hypothesis was H1: β1 ≠ 0. Only a statistically significant, negative estimate of β1 was to constitute evidence of effectiveness.||-0.06|-0.85|0.0470
72458842|NCT02291549|144440269|SUPERIORITY|||||||0.913||||||P-value adjusted for multiplicity using the Holm's step-down procedure at a 2-sided significance level of 0.05.|ANCOVA|Adjusted p-value is presented.||ANCOVA model with site and treatment group as fixed effects and contrasts constructed to estimate the difference between treatment groups. The null hypothesis was H0: β1=0 and alternative hypothesis was H1: β1 ≠ 0. Only a statistically significant, negative estimate of β1 was to constitute evidence of effectiveness.||||0.9130
72458843|NCT01970527|144440281|SUPERIORITY|||||||0.67|||||||Log Rank|||||||0.67
72458844|NCT01970527|144440283|SUPERIORITY|||||||0.71|||||||Log Rank|||||||0.71
72470059|NCT01124838|144464399|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference|-0.15||||0.164|TWO_SIDED|95.0|-0.36|0.06|||ANOVA|From ANOVA with treatment and race (Japanese versus non-Japanese) as factors adjusted for clustered observations.|The mean difference between treatment groups with its 95% confidence interval is based on individual data from all eyes adjusted for correlated measurements within a subject in an analysis of variance (ANOVA) model.|The statistical test for the ranked secondary variables was carried out in hierarchical order at the significance level of 5%.||0.06|-0.36|0.164
72500687|NCT03431012|144531708|OTHER||||||=|0.809||||||Sidak corrections were used to adjust for multiple analyses|MANOVA|||Based on the literature, it was predicted that the Virus Agency would lead to higher perceptions of susceptibility than the human agency assignment.||||=.809
72470060|NCT01124838|144464400|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference|-0.13||||0.07|TWO_SIDED|95.0|-0.28|0.01|||ANOVA|From ANOVA of change from baseline to final/early termination visit with treatment as factor|The mean difference between treatment groups with its 95% confidence interval is based on individual data from all eyes adjusted for correlated measurements within a subject in an analysis of variance (ANOVA) model.|The statistical test for the ranked secondary variables was carried out in hierarchical order at the significance level of 5%.||0.01|-0.28|0.070
72470061|NCT01124838|144464400|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference|-0.17||||0.016|TWO_SIDED|95.0|-0.31|-0.03|||ANOVA|From ANOVA with treatment and race (Japanese versus non-Japanese) as factors adjusted for clustered observations.|The mean difference between treatment groups with its 95% confidence interval is based on individual data from all eyes adjusted for correlated measurements within a subject in an analysis of variance (ANOVA) model.|The statistical test for the ranked secondary variables was carried out in hierarchical order at the significance level of 5%.||-0.03|-0.31|0.016
72470062|NCT01124838|144464401|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference|-0.04||||0.096|TWO_SIDED|95.0|-0.08|0.01|||ANOVA|From ANOVA of change from baseline to final/early termination visit with treatment as factor adjusted for clustered observations.|The mean difference between treatment groups with its 95% confidence interval is based on individual data from all eyes adjusted for correlated measurements within a subject in an analysis of variance (ANOVA) model.|The statistical test for the ranked secondary variables was carried out in hierarchical order at the significance level of 5%.||0.01|-0.08|0.096
72470063|NCT01124838|144464401|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference|-0.04||||0.044|TWO_SIDED|95.0|-0.09|0.0|||ANOVA|From ANOVA with treatment and race (Japanese versus non-Japanese) as factors adjusted for clustered observations.|The mean difference between treatment groups with its 95% confidence interval is based on individual data from all eyes adjusted for correlated measurements within a subject in an analysis of variance (ANOVA) model.|The statistical test for the ranked secondary variables was carried out in hierarchical order at the significance level of 5%.||0.00|-0.09|0.044
72470064|NCT01124838|144464402|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.75||||0.491|TWO_SIDED|95.0|0.34|1.69|||Log Rank||The hazard ratio of adalimumab versus placebo was calculated using proportional hazards regression with treatment as factor.|The statistical test for the ranked secondary variables was carried out in hierarchical order at the significance level of 5%.||1.69|0.34|0.491
72470065|NCT01124838|144464402|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.6||||0.185|TWO_SIDED|95.0|0.28|1.28|||Log Rank||The hazard ratio of adalimumab versus placebo was calculated using proportional hazards regression with treatment and race (Japanese versus non-Japanese) as factors.|The statistical test for the ranked secondary variables was carried out in hierarchical order at the significance level of 5%.||1.28|0.28|0.185
72470066|NCT01124838|144464403|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference|-2.3||||0.451|TWO_SIDED|95.0|-8.5|3.8|||ANOVA|From ANOVA of change from baseline to final/early termination visit with treatment and OCT machine as factors adjusted for clustered observations.|The mean difference between treatment groups with its 95% confidence interval is based on individual data from all eyes adjusted for correlated measurements within a subject in an analysis of variance (ANOVA) model.|The statistical test for the ranked secondary variables was carried out in hierarchical order at the significance level of 5%.||3.8|-8.5|0.451
72470067|NCT01124838|144464403|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference|-3.9||||0.174|TWO_SIDED|95.0|-9.7|1.8|||ANOVA|From ANOVA with treatment, race (Japanese versus non-Japanese) and OCT machine as factors adjusted for clustered observations.|The mean difference between treatment groups with its 95% confidence interval is based on individual data from all eyes adjusted for correlated measurements within a subject in an analysis of variance (ANOVA) model.|The statistical test for the ranked secondary variables was carried out in hierarchical order at the significance level of 5%.||1.8|-9.7|0.174
72470068|NCT01124838|144464404|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference|2.12||||0.16|TWO_SIDED|95.0|-0.84|5.08|||ANOVA|From ANOVA of change from baseline to final/early termination visit with treatment as a factor.||The statistical test for the ranked secondary variables was carried out in hierarchical order at the significance level of 5%.||5.08|-0.84|0.160
72458845|NCT01964547|144440284|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The sample size is adequate to confirm the non-inferiority of Sativex with a clinical relevant reduction delta of 10%, assuming there is no difference between treatments in the actual change in cognition and also assuming a standard deviation for treatment difference of 10, using a one-tailed 2.5% significance level and power of 90%. Sativex is deemed to be non-inferior to placebo if the lower 1-sided 97.5% CI of the estimated mean treatment difference (Sativex-Placebo) is greater than -10%.|Estimated mean treatment difference|-1.47|STANDARD_ERROR_OF_MEAN|2.492|||ONE_SIDED|97.5|-6.41||||ANCOVA|||The change at end of treatment was compared between treatment groups using ANCOVA. The model included treatment group and center grouping as factors and the baseline score as covariate. The planned sample size was 120 participants(60 patients in the Sativex arm and 60 in the placebo arm).|||-6.41|
72458846|NCT01964547|144440285|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Sativex is deemed to be non-inferior to placebo if the upper 1-sided 97.5% CI of the estimated mean treatment difference (Sativex-Placebo) is less than +5%.|Estimated mean treatment difference|-0.29|STANDARD_ERROR_OF_MEAN|1.323|||ONE_SIDED|97.5||2.33|||ANCOVA|||The change at end of treatment was compared between treatment groups using ANCOVA. The model included treatment group and center grouping as factors and the baseline score as covariate.||2.33||
72458847|NCT01964547|144440286|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|4.02||||0.0001|TWO_SIDED|95.0|1.96|8.22|||Regression, Logistic|||Data were analysed using ordinal logistic regression using the cumulative proportional odds model, with global impression of change as the dependent variable and treatment group as factor.||8.22|1.96|0.0001
72458848|NCT01964547|144440287|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.79||||0.0142|TWO_SIDED|95.0|1.23|6.31|||Regression, Logistic|||Data were analysed using ordinal logistic regression using the cumulative proportional odds model, with global impression of change as the dependent variable and treatment group as factor.||6.31|1.23|0.0142
72458849|NCT01964547|144440288|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|3.07||||0.0019|TWO_SIDED|95.0|1.51|6.21|||Regression, Logistic|||Data were analysed using ordinal logistic regression using the cumulative proportional odds model, with global impression of change as the dependent variable and treatment group as factor.||6.21|1.51|0.0019
72458850|NCT01964547|144440289|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-2.36|STANDARD_ERROR_OF_MEAN|1.88||0.212|TWO_SIDED|95.0|-6.09|1.37|||ANCOVA|||The change at end of treatment was compared between treatment groups using ANCOVA. The model included treatment group and center grouping as factors and the baseline score as covariate.||1.37|-6.09|0.212
72458851|NCT01964547|144440292|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|4.88|STANDARD_ERROR_OF_MEAN|8.25||0.556|TWO_SIDED|95.0|-11.51|21.27|||ANCOVA|||The change at end of treatment was compared between treatment groups using ANCOVA. The model included treatment group and centre grouping as factors and baseline score as covariate.||21.27|-11.51|0.556
72458852|NCT01964547|144440292|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehmann median difference|-1.0||||0.088|TWO_SIDED|95.0|-3.0|0.0|||Wilcoxon (Mann-Whitney)|||The change at end of treatment was compared between treatment groups using non-parametric methods as the distribution of data was non-normal.||0|-3|0.088
72458853|NCT04447287|144440310|OTHER||Geometric LS Mean Ratio|89.72|||||TWO_SIDED|90.0|81.21|99.11||||||||99.11|81.21|
72620905|NCT00452400|144772831|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.141|STANDARD_ERROR_OF_MEAN|0.032|<|0.0001||95.0|0.078|0.204|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 2 mcg qd minus Placebo|||0.204|0.078|<0.0001
72620906|NCT00452400|144772831|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.162|STANDARD_ERROR_OF_MEAN|0.032|<|0.0001||95.0|0.099|0.225|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 5 mcg qd minus Placebo|||0.225|0.099|<0.0001
72458854|NCT04447287|144440311|OTHER||Geometric LS Mean Ratio|92.15|||||TWO_SIDED|90.0|80.22|105.86||||||||105.86|80.22|
72458855|NCT04447287|144440312|OTHER||Geometric LS Mean Ratio|109.09|||||TWO_SIDED|90.0|101.1|117.71||||||||117.71|101.10|
72458856|NCT04447287|144440313|OTHER||Geometric LS Mean Ratio|117.77|||||TWO_SIDED|90.0|106.41|130.34||||||||130.34|106.41|
72458857|NCT04447287|144440314|OTHER||Geometric LS Mean Ratio|79.39|||||TWO_SIDED|90.0|68.1|92.55||||||||92.55|68.10|
72458858|NCT04447287|144440315|OTHER||Geometric LS Mean Ratio|74.45|||||TWO_SIDED|90.0|59.28|93.5||||||||93.50|59.28|
72620907|NCT00452400|144772831|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.213|STANDARD_ERROR_OF_MEAN|0.031|<|0.0001||95.0|0.151|0.275|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 10 mcg qd minus Placebo|||0.275|0.151|<0.0001
72620908|NCT00452400|144772831|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.214|STANDARD_ERROR_OF_MEAN|0.032|<|0.0001||95.0|0.151|0.277|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 20 mcg qd minus Placebo|||0.277|0.151|<0.0001
72458859|NCT03246724|144440322|NON_INFERIORITY|A non-inferiority margin of 0.5, will assure that, if non-inferiority is proven, the mean patient satisfaction with oral sedation will correspond to scores corresponding to satisfied or higher. A 0.5 margin to be considered clinically similar enough to declare non-inferiority because it allows for expected patient satisfaction variability, and demonstrates ample justification for providers to offer oral sedation as a safe alternative.|||||<|0.05||||||As a sensitivity analysis, an ANCOVA model will be fit to the data adjusting for factors that are out of balance following randomization. The mean difference between the adjusted means will be calculated.|ANCOVA|If lower bound of the 90% two-sided Confidence Interval of mean difference is higher than -0.5, the oral sedation will be deemed non-inferior to IV.||"Testable hypothesis: Patient satisfaction mean will be non-inferior when given oral triazolam in comparison to IV midazolam during all basic cataracts, retina, cornea, and glaucoma ocular procedures.~Null hypothesis: The null hypothesis is that the oral sedation group will have a primary endpoint mean equal to or less than that of the IV sedation group by the non-inferiority margin or more."||||<0.05
72470069|NCT01124838|144464404|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference|1.77||||0.205|TWO_SIDED|95.0|-0.97|4.52|||ANOVA|From ANOVA of change from baseline to final/early termination visit with treatment and race (Japanese versus non-Japanese) as factors.||The statistical test for the ranked secondary variables was carried out in hierarchical order at the significance level of 5%.||4.52|-0.97|0.205
72500688|NCT03431012|144531709|OTHER|||||||0.025||||||Sidak corrections were used to adjust for multiple analyses.|MANOVA|||Based on the literature, it was predicted that the Virus Agency would lead to higher perceptions of severity of the pandemic than the human agency assignment.||||0.025
72563049|NCT02093923|144658127|SUPERIORITY||Percent Change in Mean Rate|-85.24||||0.0141||95.0|-96.79|-32.03|||Mixed Models Analysis|||The result was based on General Estimating Equation (GEE) analysis. Generalized Estimating Equation (GEE) approach with Poisson distribution assumption was applied to the repeated-measures mixed model with independence working correlation structure. The treatment group was a fixed effect and the number of baseline HAE attacks per week was included as a covariate in the GEE.||-32.03|-96.79|0.0141
72563050|NCT02093923|144658127|SUPERIORITY||Percent Change in Mean Rate|-89.35||||0.004|TWO_SIDED|95.0|-97.68|-51.13|||Mixed Models Analysis|||The result was based on General Estimating Equation (GEE) analysis. Generalized Estimating Equation (GEE) approach with Poisson distribution assumption was applied to the repeated-measures mixed model with independence working correlation structure. The treatment group was a fixed effect and the number of baseline HAE attacks per week was included as a covariate in the GEE.||-51.13|-97.68|0.0040
72620909|NCT00452400|144772832|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.164|STANDARD_ERROR_OF_MEAN|0.034|<|0.0001||95.0|0.097|0.231|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 2 mcg qd minus Placebo|||0.231|0.097|<0.0001
72563051|NCT00442546|144658142|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.038|STANDARD_ERROR_OF_MEAN|0.37||0.9185||95.0|-0.766|0.691||A step-down procedure was used for multiple comparisons adjustment. If the difference between the high dose and placebo groups was statistically significant (p\<0.05), then the next step conducted where the low dose group was compared to placebo.|ANOVA|Least squares means from the analysis of variance (ANOVA) model with main effects of treatment and center and Baseline mean worst pain score.|Mean difference (final values) = Least squares mean difference|||0.691|-0.766|0.9185
72563052|NCT00442546|144658142|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.339|STANDARD_ERROR_OF_MEAN|0.371||0.3619||95.0|-1.07|0.392||A step-down procedure was used for multiple comparisons adjustment. If the difference between the high dose and placebo groups was statistically significant (p\<0.05), then the next step conducted where the low dose group was compared to placebo.|ANOVA|Least squares means from the ANOVA model with main effects of treatment and center and Baseline mean worst pain score.|Mean difference (final values) = Least squares mean difference|||0.392|-1.070|0.3619
72563053|NCT00442546|144658143|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-16.065|STANDARD_ERROR_OF_MEAN|19.426||0.4091||95.0|-54.332|22.203|||ANOVA||Mean difference (final values) = Least squares mean difference|24 hours||22.203|-54.332|0.4091
72563054|NCT00442546|144658143|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-15.548|STANDARD_ERROR_OF_MEAN|19.388||0.4234||95.0|-53.74|22.645|||ANOVA||Mean difference (final values) = Least squares mean difference|24 hours||22.645|-53.740|0.4234
72563055|NCT00442546|144658143|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-36.428|STANDARD_ERROR_OF_MEAN|16.517||0.0284||95.0|-68.972|-3.884|||ANOVA||Mean difference (final values) = Least squares mean difference|48 hours||-3.884|-68.972|0.0284
72563056|NCT00442546|144658143|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-28.985|STANDARD_ERROR_OF_MEAN|16.57||0.0816||95.0|-61.632|3.663|||ANOVA||Mean difference (final values) = Least squares mean difference|48 hours||3.663|-61.632|0.0816
72620910|NCT00452400|144772832|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.169|STANDARD_ERROR_OF_MEAN|0.034|<|0.0001||95.0|0.102|0.237|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 5 mcg qd minus Placebo|||0.237|0.102|<0.0001
72620911|NCT00452400|144772832|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.218|STANDARD_ERROR_OF_MEAN|0.034|<|0.0001||95.0|0.152|0.284|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 10 mcg qd minus Placebo|||0.284|0.152|<0.0001
72563057|NCT00442546|144658143|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.759|STANDARD_ERROR_OF_MEAN|11.752||0.8147||95.0|-20.446|25.964|||ANOVA||Mean difference (final values) = Least squares mean difference|72 hours||25.964|-20.446|0.8147
72370500|NCT00488683|144251632|SUPERIORITY_OR_OTHER||R-square|0.02||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and hSBA titers one month after booster vaccination for the serogroup Y||||
72500689|NCT03431012|144531710|OTHER||||||=|0.199||||||Sidak corrections were used to adjust for multiple analyses.|MANOVA|||Based on the literature, we predicted that the Agency Assignment would not affect self-efficacy, i.e. people's perceived ability to use the antivirals as recommended.||||=0.199
72500690|NCT03431012|144531711|OTHER||||||=|0.484||||||Sidak corrections were used to adjust for multiple analyses.|MANOVA|||Based on the literature, we predicted that Positive framing of the side effects would lead to higher response efficacy.||||=0.484
72563058|NCT00442546|144658143|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.182|STANDARD_ERROR_OF_MEAN|11.589||0.7187||95.0|-27.064|18.7|||ANOVA||Mean difference (final values) = Least squares mean difference|72 hours||18.700|-27.064|0.7187
72563059|NCT00442546|144658143|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.356|STANDARD_ERROR_OF_MEAN|10.148||0.7416||95.0|-23.516|16.804|||ANOVA||Mean difference (final values) = Least squares mean difference|96 hours||16.804|-23.516|0.7416
72563060|NCT00442546|144658143|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-10.574|STANDARD_ERROR_OF_MEAN|9.283||0.2577||95.0|-29.017|7.869|||ANOVA||Mean difference (final values) = Least squares mean difference|96 hours||7.869|-29.017|0.2577
72563061|NCT00442546|144658143|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.039|STANDARD_ERROR_OF_MEAN|17.387||0.9982||95.0|-36.431|36.352|||ANOVA||Mean difference (final values) = Least squares mean difference|120 hours||36.352|-36.431|0.9982
72563062|NCT00442546|144658143|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-13.325|STANDARD_ERROR_OF_MEAN|22.184||0.5552||95.0|-59.756|33.107|||ANOVA||Mean difference (final values) = Least squares mean difference|120 hours||33.107|-59.756|0.5552
72563063|NCT00442546|144658143|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-40.0|STANDARD_ERROR_OF_MEAN|24.655||0.2032||95.0|-118.463|38.463|||ANOVA||Mean difference (final values) = Least squares mean difference|144 hours||38.463|-118.463|0.2032
72458860|NCT03246724|144440323|NON_INFERIORITY|A non-inferiority margin of 0.5, will assure that, if non-inferiority is proven, the mean patient satisfaction with oral sedation will correspond to scores corresponding to satisfied or higher. We determined a 0.5 margin to be considered clinically similar enough to declare non-inferiority because it allows for expected patient satisfaction variability, and demonstrates ample justification for providers to offer oral sedation as a safe alternative.|||||<|0.05||||||Surgeon satisfaction score will be independently analyzed. Summary statistics including, means, standard deviations along with points estimates of the mean difference between the two groups and 90% Confidence Intervals.|ANCOVA|If lower bound of the 90% two-sided Confidence Interval of mean difference is higher than -0.5, oral sedation will be deemed non-inferior to IV.||"Null hypothesis: Mean surgeon satisfaction score for oral triazolam will be statistically significant in comparison to mean surgeon satisfaction score for IV midazolam during all cataracts, retina, cornea, and glaucoma ocular procedures.~Alternate hypothesis: Mean surgeon satisfaction score for oral triazolam will not be statistically significant in comparison to mean surgeon satisfaction score for IV midazolam during all cataracts, retina, cornea, and glaucoma ocular procedures."||||<0.05
72458861|NCT03246724|144440324|NON_INFERIORITY|A non-inferiority margin of 0.5, will assure that, if non-inferiority is proven, the mean patient satisfaction with oral sedation will correspond to scores corresponding to satisfied or higher. We determined a 0.5 margin to be considered clinically similar enough to declare non-inferiority because it allows for expected patient satisfaction variability, and demonstrates ample justification for providers to offer oral sedation as a safe alternative.|||||<|0.05||||||Anesthesiologist/CRNA satisfaction score will be independently analyzed. Summary statistics including, means, standard deviations along with points estimates of the mean difference between the two groups and 90% Confidence Intervals.|ANCOVA|If lower bound of the 90% two-sided Confidence Interval of mean difference is higher than -0.5, the oral sedation will be deemed non-inferior to IV.||"Null hypothesis: Mean anesthesiologist/CRNA satisfaction score for oral triazolam will be statistically significant in comparison to mean anesthesiologist/CRNA satisfaction score for IV midazolam during cataracts, retina, cornea, and glaucoma procedures.~Alternate hypothesis:Mean anesthesiologist/CRNA satisfaction score for oral triazolam will not be statistically significant in comparison to mean satisfaction score for IV midazolam during cataracts, retina, cornea, and glaucoma procedures."||||<0.05
72458862|NCT03246724|144440325|OTHER|Additional anesthesia intervention will be using summary statistics including, counts and proportions along with point's estimates of the proportion difference between the two groups and 90% Confidence Intervals.|||||<|0.05|||||||t-test, 2 sided|||"Null hypothesis:The total additional anesthesia interventions for oral triazolam will be statistically significant in comparison to additional anesthesia interventions for IV midazolam during cataracts, retina, cornea, and glaucoma procedures.~Alternate hypothesis:The total additional anesthesia interventions for oral triazolam will not be statistically significant in comparison to additional anesthesia interventions for IV midazolam during cataracts, retina, cornea, and glaucoma procedures"||||<0.05
72458863|NCT03246724|144440326|OTHER|Surgical complications will be using summary statistics including, counts and proportions along with point's estimates of the proportion difference between the two groups and 90% Confidence Intervals.|||||<|0.05|||||||t-test, 2 sided|||"Null hypothesis: The total surgical complications for oral triazolam will be statistically significant in comparison to total surgical complications for IV midazolam during all cataracts, retina, cornea, and glaucoma ocular procedures.~Alternate hypothesis: The total surgical complications for oral triazolam will not be statistically significant in comparison to total surgical complications for IV midazolam during all cataracts, retina, cornea, and glaucoma ocular procedures."||||<0.05
72458864|NCT02255474|144440335|SUPERIORITY||Mean Difference (Final Values)|-1.01|||<|0.01|TWO_SIDED|||||Adjusted for multiple comparisons, treatment group p-value|Mixed Models Analysis|||Both eyes used in analysis adjusting for correlation.||||<0.01
72458865|NCT02255474|144440336|SUPERIORITY||quadratic coefficient|0.02||||0.05|TWO_SIDED||||||Mixed Models Analysis|||Individual subject eye length profiles were fit using quadratic equations as a function of gaze angle. The analysis of quadratic coefficients included treatment group, study year (categorical variable), and their interaction adjusted for age, study site, and ethnicity.||||0.05
72458866|NCT02255474|144440337|SUPERIORITY||regression coefficient|-0.12||||0.05|TWO_SIDED||||||Regression, Linear|Models control for age, sex, axial length at baseline, race, treatment group, treatment group by race interaction.||This analysis looks at the three-year change in spherical equivalent refractive error for different eccentricities of peripheral defocus measured with contact lenses in place||||0.05
72458867|NCT02255474|144440338|SUPERIORITY||Mean Difference (Final Values)|0.62||||0.05|TWO_SIDED|||||Adjusted for multiple comparisons|Mixed Models Analysis|||Both eyes used in the analysis controlling for the correlation.||||0.05
72458868|NCT01082159|144440345|SUPERIORITY_OR_OTHER||change from baseline|3.59|STANDARD_DEVIATION|2.87|<|0.0001|TWO_SIDED|95.0|2.76|4.42|||t-test, 2 sided|||||4.42|2.76|<0.0001
72458869|NCT01082159|144440346|SUPERIORITY_OR_OTHER||Change from Baseline|12.17|STANDARD_DEVIATION|19.14|<|0.0001|TWO_SIDED|95.0|6.64|17.71|||t-test, 2 sided|||||17.71|6.64|<0.0001
72458870|NCT02367794|144440359|SUPERIORITY||Hazard Ratio (HR)|0.75||||0.0006|TWO_SIDED|95.0|0.64|0.88|||Log Rank|||||0.88|0.64|0.0006
72458871|NCT02367794|144440360|SUPERIORITY||Hazard Ratio (HR)|0.88||||0.1581|TWO_SIDED|95.0|0.73|1.05|||Log Rank|||||1.05|0.73|0.1581
72458872|NCT02367794|144440361|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.876||||0.4451|TWO_SIDED|95.0|0.623|1.231|||Log Rank|||Teff \>=-1.91 in ITT||1.231|0.623|0.4451
72563064|NCT00442546|144658143|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-138.5|STANDARD_ERROR_OF_MEAN|37.661||0.0348||95.0|-258.354|-18.646|||ANOVA||Mean difference (final values) = Least squares mean difference|144 hours||-18.646|-258.354|0.0348
72458873|NCT02367794|144440361|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.941||||0.7343|TWO_SIDED|95.0|0.664|1.335|||Log Rank|||Teff \>=-1.91 in ITT||1.335|0.664|0.7343
72458874|NCT02367794|144440361|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.942||||0.661|TWO_SIDED|95.0|0.72|1.232|||Log Rank|||Teff \<-1.91 Negative in ITT||1.232|0.720|0.6610
72458875|NCT02367794|144440361|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|1.253||||0.0893|TWO_SIDED|95.0|0.965|1.627|||Log Rank|||Teff \<-1.91 Negative in ITT||1.627|0.965|0.0893
72563065|NCT00442546|144658144|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.136|STANDARD_ERROR_OF_MEAN|4.499||0.3602||95.0|-4.79|13.062|||ANOVA||Mean Difference (Final Values) = Least Squares Mean Difference|Week 2||13.062|-4.790|0.3602
72458876|NCT02367794|144440362|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.61||||0.0006|TWO_SIDED|95.0|0.46|0.81|||Log Rank|||Teff\>=-1.91||0.81|0.46|0.0006
72500691|NCT03431012|144531712|OTHER||||||=|0.494||||||Sidak corrections were used to adjust for multiple analyses.|MANOVA|||Based on the literature, we predicted that Positive framing of the side effects would lead to lower response costs compared to Negative Framing.||||=0.494
72563066|NCT00442546|144658144|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.573|STANDARD_ERROR_OF_MEAN|4.637||0.7352||95.0|-7.626|10.771|||ANOVA||Mean Difference (Final Values) = Least Squares Mean Difference|Week 2||10.771|-7.626|0.7352
72563067|NCT00442546|144658144|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.86|STANDARD_ERROR_OF_MEAN|6.156||0.6435||95.0|-9.392|15.111|||ANOVA||Mean Difference (Final Values) = Least Squares Mean Difference|Week 4||15.111|-9.392|0.6435
72563068|NCT00442546|144658144|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.237|STANDARD_ERROR_OF_MEAN|6.361||0.6123||95.0|-9.422|15.895|||ANOVA||Mean Difference (Final Values) = Least Squares Mean Difference|Week 4||15.895|-9.422|0.6123
72563069|NCT00442546|144658144|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.65|STANDARD_ERROR_OF_MEAN|7.663||0.6356||95.0|-11.683|18.984|||ANOVA||Mean Difference (Final Values) = Least Squares Mean Difference|Week 6/ET||18.984|-11.683|0.6356
72563070|NCT00442546|144658144|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.909|STANDARD_ERROR_OF_MEAN|7.747||0.907||95.0|-14.593|16.411|||ANOVA||Mean Difference (Final Values) = Least Squares Mean Difference|Week 6/ET||16.411|-14.593|0.9070
72563071|NCT00442546|144658145|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1190.65|STANDARD_ERROR_OF_MEAN|123.062||0.0656||95.0|-2754.304|373.004|||ANOVA||Mean Difference (Final Values) = Least Squares Mean Difference|Acetylsalicylic Acid, 72 hours||373.004|-2754.304|0.0656
72563072|NCT00442546|144658145|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|16.2|STANDARD_ERROR_OF_MEAN|142.1||0.9277||95.0|-1789.352|1821.752|||ANOVA||Mean Difference (Final Values) = Least Squares Mean Difference|Acetylsalicylic Acid, 72 hours||1821.752|-1789.352|0.9277
72458877|NCT02367794|144440362|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|1.06||||0.63|TWO_SIDED|95.0|0.84|1.33|||Log Rank|||Teff\>=-1.91||1.33|0.84|0.630
72563073|NCT00442546|144658145|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.771|STANDARD_ERROR_OF_MEAN|62.692||0.935||95.0|-263.972|275.515|||ANOVA||Mean Difference (Final Values) = Least Squares Mean Difference|Ketorolac, 24 hours||275.515|-263.972|0.9350
72563074|NCT00442546|144658145|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|26.243|STANDARD_ERROR_OF_MEAN|44.33||0.6139||95.0|-164.494|216.98|||ANOVA||Mean Difference (Final Values) = Least Squares Mean Difference|Ketorolac, 24 hours||216.980|-164.494|0.6139
72458878|NCT02367794|144440362|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.88||||0.258|TWO_SIDED|95.0|0.7|1.1|||Log Rank|||Teff\<-1.91||1.10|0.70|0.258
72458879|NCT02367794|144440362|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|1.06||||0.63|TWO_SIDED|95.0|0.84|1.33|||Log Rank|||Teff\<-1.91||1.33|0.84|0.630
72458880|NCT02367794|144440363|SUPERIORITY|Unstratified Analysis|Hazard Ratio (HR)|0.53|||<|0.0001|TWO_SIDED|95.0|0.4|0.72|||Log Rank|||||0.72|0.40|<.0001
72500692|NCT01025635|144531718|SUPERIORITY_OR_OTHER_LEGACY|||||||0.017|||||||Cochran-Mantel-Haenszel|study center adjusted||||||0.017
72500693|NCT01025635|144531719|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||ANCOVA|with factors treatment group, study center, and baseline lesion count as covariate||||||<0.001
72500694|NCT00929240|144531724|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.383|||<|0.0001|TWO_SIDED|95.0|0.266|0.551||Stratified by interactive voice/Web response system (IVRS), estrogen receptor (ER) status, visceral metastasis (yes/no), response to initial phase, and lactate dehydrogenase (LDH) level.|Log Rank||Stratified by IVRS, ER status, visceral metastasis (yes/no), response to initial phase, and LDH level.|||0.551|0.266|<0.0001
72500695|NCT00929240|144531724|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.429|||<|0.0001|TWO_SIDED|95.0|0.309|0.597|||Log Rank|Unstratified analysis||||0.597|0.309|<0.0001
72563075|NCT00442546|144658145|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.92|STANDARD_ERROR_OF_MEAN|9.96||0.776||95.0|-25.451|19.611|||ANOVA||Mean Difference (Final Values) = Least Squares Mean Difference|Ketorolac, 48 hours||19.611|-25.451|0.7760
72563076|NCT00442546|144658145|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.61|STANDARD_ERROR_OF_MEAN|6.833||0.819||95.0|-17.066|13.846|||ANOVA||Mean Difference (Final Values) = Least Squares Mean Difference|Ketorolac, 48 hours||13.846|-17.066|0.8190
72563077|NCT00442546|144658145|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-69.235|STANDARD_ERROR_OF_MEAN|390.483||0.8603||95.0|-861.171|722.7|||ANOVA||Mean Difference (Final Values) = Least Squares Mean Difference|Paracetamol, 24 hours||722.700|-861.171|0.8603
72563078|NCT00442546|144658145|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-17.395|STANDARD_ERROR_OF_MEAN|384.376||0.9642||95.0|-796.945|762.155|||ANOVA||Mean Difference (Final Values) = Least Squares Mean Difference|Paracetamol, 24 hours||762.155|-796.945|0.9642
72563079|NCT00442546|144658145|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|93.693|STANDARD_ERROR_OF_MEAN|484.957||0.8476||95.0|-880.865|1068.251|||ANOVA||Mean Difference (Final Values) = Least Squares Mean Difference|Paracetamol, 48 hours||1068.251|-880.865|0.8476
72563080|NCT00442546|144658145|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|105.543|STANDARD_ERROR_OF_MEAN|457.374||0.8185||95.0|-813.584|1024.67|||ANOVA||Mean Difference (Final Values) = Least Squares Mean Difference|Paracetamol, 48 hours||1024.670|-813.584|0.8185
72563081|NCT00442546|144658145|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-682.304|STANDARD_ERROR_OF_MEAN|495.241||0.1792||95.0|-1696.759|332.15|||ANOVA||Mean Difference (Final Values) = Least Squares Mean Difference|Paracetamol, 72 hours||332.150|-1696.759|0.1792
72563082|NCT00442546|144658145|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-250.439|STANDARD_ERROR_OF_MEAN|501.808||0.6216||95.0|-1278.347|777.469|||ANOVA||Mean Difference (Final Values) = Least Squares Mean Difference|Paracetamol, 72 hours||777.469|-1278.347|0.6216
72563083|NCT00442546|144658146|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-494.0|STANDARD_ERROR_OF_MEAN|301.253||0.1996||95.0|-1452.72|464.72|||ANOVA||Mean Difference (Final Values) = Least Squares Mean Difference|Acetylsalicylic Acid, Week 2.||464.720|-1452.720|0.1996
72563084|NCT00442546|144658146|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-195.15|STANDARD_ERROR_OF_MEAN|368.958||0.6335||95.0|-1369.338|979.038|||ANOVA||Mean Difference (Final Values) = Least Squares Mean Difference|Acetylsalicylic Acid, Week 2.||979.038|-1369.338|0.6335
72500696|NCT00929240|144531725|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.1||||0.113|TWO_SIDED|95.0|-2.1|20.3|||Chi-squared||CIs with Hauck-Anderson adjustment for difference in rates of bevacizumab + capecitabine arm to bevacizumab alone arm.|||20.3|-2.1|0.113
72500697|NCT00929240|144531726|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.0||||0.58|TWO_SIDED|95.0|-2.6|4.6|||Chi-squared||CIs with Hauck-Anderson adjustment for difference in rates of Bevacizumab+Capecitabine group to Bevacizumab only group.|||4.6|-2.6|0.580
72500698|NCT00929240|144531728|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.425|||<|0.0003|TWO_SIDED|95.0|0.263|0.685||Stratified by IVRS, ER status, visceral metastasis (yes/no), response to initial phase, and LDH level.|Log Rank|||||0.685|0.263|<0.0003
72500699|NCT00929240|144531728|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.516||||0.002|TWO_SIDED|95.0|0.334|0.798||Unstratified analysis|Log Rank|||||0.798|0.334|0.002
72500700|NCT00929240|144531731|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.383|||<|0.0001|TWO_SIDED|95.0|0.266|0.551||Stratified by IVRS, ER status, visceral metastasis (yes/no), response to initial phase, and LDH level.|Log Rank||Stratification variables are randomisation stratification parameters as of IVRS: ER status, Visceral metastasis (yes/no), Response to initial phase, LDH concentration level.|||0.551|0.266|<0.0001
72500701|NCT00929240|144531731|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.425|||<|0.0001|TWO_SIDED|95.0|0.305|0.591||Unstratified analysis|Log Rank||Hazard ratio was determined using the cox regression model.|||0.591|0.305|<0.0001
72500702|NCT05292755|144531735|OTHER|One-way ANOVA was used to compare mean Faith's phylogenetic diversity before and after treatment for each intervention group at a two-tailed 95% confidence interval.||||||0.232|||||||ANOVA|||||||0.232
72500703|NCT05292755|144531736|OTHER|||||||0.224|||||||ANOVA|||ANOVA was used to compare mean Shannon's diversity indices before and after treatment for each intervention group at a two-tailed 95% confidence interval.||||0.224
72500704|NCT05292755|144531737|OTHER|||||||0.227|||||||Repeated measures Mann-U-Whitney|||Repeated measures Mann-U-Whitney tests were used to compare changes in weighted and unweighted UniFrac distances between intervention groups before and after intervention at a two-tailed 95% confidence interval.||||0.227
72500705|NCT00432809|144531741|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED|95.0|||||Chi-squared|||||||0.002
72500706|NCT00432809|144531741|SUPERIORITY_OR_OTHER|||||||0.008||95.0|||||Chi-squared|||||||0.008
72500707|NCT00432809|144531741|SUPERIORITY_OR_OTHER|||||||0.59||95.0||||Not adjusted for multiple comparisons|Chi-squared|||||||0.59
72563085|NCT00442546|144658146|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-27.291|STANDARD_ERROR_OF_MEAN|302.355||0.929||95.0|-657.992|603.41|||ANOVA||Mean Difference (Final Values) = Least Squares Mean Difference|Paracetamol, Week 2||603.410|-657.992|0.9290
72563086|NCT00442546|144658146|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|34.787|STANDARD_ERROR_OF_MEAN|256.969||0.8937||95.0|-501.241|570.815|||ANOVA||Mean Difference (Final Values) = Least Squares Mean Difference|Paracetamol, Week 2||570.815|-501.241|0.8937
72500708|NCT00432809|144531745|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA|||||||<0.001
72620912|NCT00452400|144772832|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.225|STANDARD_ERROR_OF_MEAN|0.034|<|0.0001||95.0|0.157|0.292|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 20 mcg qd minus Placebo|||0.292|0.157|<0.0001
72458881|NCT02367794|144440363|SUPERIORITY|Unstratified Analysis|Hazard Ratio (HR)|0.61||||0.0018|TWO_SIDED|95.0|0.45|0.84|||Log Rank|||||0.84|0.45|0.0018
72500709|NCT00432809|144531745|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA|||||||<0.001
72500710|NCT00432809|144531745|SUPERIORITY_OR_OTHER|||||||0.85||95.0|||||ANOVA|||||||0.85
72500711|NCT00432809|144531746|SUPERIORITY_OR_OTHER|||||||0.004||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.004
72500712|NCT00432809|144531746|SUPERIORITY_OR_OTHER|||||||0.003||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.003
72500713|NCT00432809|144531746|SUPERIORITY_OR_OTHER|||||||0.86||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.86
72500714|NCT00432809|144531747|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA|||||||<0.001
72500715|NCT00432809|144531747|SUPERIORITY_OR_OTHER|||||||0.003||95.0|||||ANOVA|||||||0.003
72500716|NCT00432809|144531747|SUPERIORITY_OR_OTHER|||||||0.23||95.0|||||ANOVA|||||||0.23
72500717|NCT00432809|144531748|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Chi-squared|||Medical Therapy vs. Gastric Bypass||||<0.001
72500718|NCT00432809|144531748|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||||||<0.001
72458882|NCT02367794|144440364|SUPERIORITY|Unstratified Analysis|Hazard Ratio (HR)|0.61|||<|0.0001|TWO_SIDED|95.0|0.48|0.77|||Log Rank|||||0.77|0.48|<.0001
72458883|NCT02367794|144440364|SUPERIORITY|Unstratified Analysis|Hazard Ratio (HR)|0.61|||<|0.0001|TWO_SIDED|95.0|0.48|0.77|||Log Rank|||||0.77|0.48|<.0001
72458884|NCT02367794|144440365|SUPERIORITY|Unstratified Analysis|Hazard Ratio (HR)|0.725||||0.0518|TWO_SIDED|95.0|0.524|1.004|||Log Rank|||||1.004|0.524|0.0518
72458885|NCT02367794|144440365|SUPERIORITY|Unstratified Analysis|Hazard Ratio (HR)|0.832||||0.2841|TWO_SIDED|95.0|0.594|1.165|||Log Rank|||||1.165|0.594|0.2841
72458886|NCT02367794|144440366|SUPERIORITY|Unstratified Analysis|Hazard Ratio (HR)|0.871||||0.2956|TWO_SIDED|95.0|0.671|1.129|||Log Rank|||||1.129|0.671|0.2956
72458887|NCT02367794|144440366|SUPERIORITY|Unstratified Analysis|Hazard Ratio (HR)|0.861||||0.2473|TWO_SIDED|95.0|0.668|1.109|||Log Rank|||||1.109|0.668|0.2473
72500719|NCT00432809|144531748|SUPERIORITY_OR_OTHER|||||||0.1||95.0|||||Chi-squared|||||||0.10
72500720|NCT00432809|144531749|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA|||||||<0.001
72500721|NCT00432809|144531749|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA|||||||<0.001
72500722|NCT00432809|144531749|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||ANOVA|||||||0.02
72500723|NCT00432809|144531750|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA|||||||<0.001
72563087|NCT00442546|144658146|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|198.937|STANDARD_ERROR_OF_MEAN|491.153||0.6912||95.0|-847.93|1245.804|||ANOVA||Mean Difference (Final Values) = Least Squares Mean Difference|Paracetamol, Week 4||1245.804|-847.930|0.6912
72563088|NCT00442546|144658146|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|185.728|STANDARD_ERROR_OF_MEAN|349.047||0.6024||95.0|-558.248|929.704|||ANOVA||Mean Difference (Final Values) = Least Squares Mean Difference|Paracetamol, Week 4||929.704|-558.248|0.6024
72620913|NCT00452400|144772833|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.262|STANDARD_ERROR_OF_MEAN|0.057|<|0.0001||95.0|0.15|0.373|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 2 mcg qd minus Placebo|||0.373|0.150|<0.0001
72458888|NCT02367794|144440367|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.41||||0.0248|TWO_SIDED|95.0|1.04|1.91|||Cochran-Mantel-Haenszel|||||1.91|1.04|0.0248
72458889|NCT02367794|144440367|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.4||||0.0308|TWO_SIDED|95.0|1.03|1.9|||Cochran-Mantel-Haenszel|||||1.90|1.03|0.0308
72458890|NCT02367794|144440368|SUPERIORITY|Unstratified Analysis|Hazard Ratio (HR)|0.53|||<|0.0001|TWO_SIDED|95.0|0.408|0.689|||Log Rank|||||0.689|0.408|<.0001
72500724|NCT00432809|144531750|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA|||||||<0.001
72500725|NCT00432809|144531750|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||ANOVA|||||||0.02
72500726|NCT00432809|144531751|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA|||||||<0.001
72500727|NCT00432809|144531751|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA|||||||<0.001
72500728|NCT00432809|144531751|SUPERIORITY_OR_OTHER|||||||0.61||95.0|||||ANOVA|||||||0.61
72563089|NCT00442546|144658146|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-256.921|STANDARD_ERROR_OF_MEAN|407.391||0.5372||95.0|-1120.551|606.709|||ANOVA||Mean Difference (Final Values) = Least Squares Mean Difference|Paracetamol, Week 6/ET||606.709|-1120.551|0.5372
72563090|NCT00442546|144658146|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-287.032|STANDARD_ERROR_OF_MEAN|328.227||0.3948||95.0|-982.843|408.778|||ANOVA||Mean Difference (Final Values) = Least Squares Mean Difference|Paracetamol, Week 6/ET||408.778|-982.843|0.3948
72620914|NCT00452400|144772833|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.283|STANDARD_ERROR_OF_MEAN|0.057|<|0.0001||95.0|0.171|0.395|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 5 mcg qd minus Placebo|||0.395|0.171|<0.0001
72370501|NCT00488683|144251632|SUPERIORITY_OR_OTHER||R-square|0.02||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between memory B cells one month after primary vaccination and hSBA titers one month after booster vaccination for the serogroup Y||||
72458891|NCT02367794|144440368|SUPERIORITY|Unstratified Analysis|Hazard Ratio (HR)|0.64||||0.0007|TWO_SIDED|95.0|0.493|0.831|||Log Rank|||||0.831|0.493|0.0007
72500729|NCT00432809|144531752|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA|||||||<0.001
72458892|NCT02367794|144440369|SUPERIORITY||Difference in Event Free Rate|0.06||||0.9871|TWO_SIDED|95.0|-7.48|7.61|||Z-test|||Event Free Rate (%) at Year 1||7.61|-7.48|0.9871
72458893|NCT02367794|144440369|SUPERIORITY||Difference in Event Free Rate|5.93||||0.1133|TWO_SIDED|95.0|-1.41|13.26|||Z-test|||Event Free Rate (%) at Year 2||13.26|-1.41|0.1133
72458894|NCT02367794|144440369|SUPERIORITY||Difference in Event Free Rate|-3.97||||0.3072|TWO_SIDED|95.0|-11.6|3.65|||Z-test|||Event Free Rate (%) at Year 1||3.65|-11.60|0.3072
72458895|NCT02367794|144440369|SUPERIORITY||Difference in Event Free Rate|1.21||||0.743|TWO_SIDED|95.0|-6.01|8.42|||Z-test|||Event Free Rate (%) at Year 2||8.42|-6.01|0.7430
72458896|NCT02367794|144440370|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.797||||0.0461|TWO_SIDED|95.0|0.638|0.996|||Log Rank|||||0.996|0.638|0.0461
72458897|NCT02367794|144440370|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|1.04||||0.7295|TWO_SIDED|95.0|0.834|1.296|||Log Rank|||||1.296|0.834|0.7295
72458898|NCT02367794|144440371|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.828||||0.0942|TWO_SIDED|95.0|0.663|1.033|||Log Rank|||||1.033|0.663|0.0942
72458899|NCT02367794|144440371|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.968||||0.7709|TWO_SIDED|95.0|0.776|1.207|||Log Rank|||||1.207|0.776|0.7709
72500730|NCT00432809|144531752|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA|||||||<0.001
72500731|NCT00432809|144531752|SUPERIORITY_OR_OTHER|||||||0.03||95.0|||||ANOVA|||||||0.03
72500732|NCT00432809|144531753|SUPERIORITY_OR_OTHER|||||||0.87||95.0|||||ANOVA|||||||0.87
72500733|NCT00432809|144531753|SUPERIORITY_OR_OTHER|||||||0.67||95.0|||||ANOVA|||||||0.67
72500734|NCT00432809|144531753|SUPERIORITY_OR_OTHER|||||||0.46||95.0|||||ANOVA|||||||0.46
72500735|NCT00432809|144531754|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||ANOVA|||||||0.001
72500736|NCT00432809|144531754|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||ANOVA|||||||0.001
72500737|NCT00432809|144531754|SUPERIORITY_OR_OTHER|||||||0.98||95.0|||||ANOVA|||||||0.98
72500738|NCT00432809|144531755|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.002
72500739|NCT00432809|144531755|SUPERIORITY_OR_OTHER|||||||0.08||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.08
72500740|NCT00432809|144531755|SUPERIORITY_OR_OTHER|||||||0.17||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.17
72500741|NCT00432809|144531756|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.001
72500742|NCT00432809|144531756|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.001
72500743|NCT00432809|144531756|SUPERIORITY_OR_OTHER|||||||0.59||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.59
72500744|NCT00432809|144531757|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||||||<0.001
72500745|NCT00432809|144531757|SUPERIORITY_OR_OTHER|||||||1.001||95.0|||||Chi-squared|||||||1.001
72500746|NCT00432809|144531757|SUPERIORITY_OR_OTHER|||||||0.68||95.0|||||Chi-squared|||||||0.68
72500747|NCT00432809|144531758|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||||||<0.001
72500748|NCT00432809|144531758|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||||||<0.001
72500749|NCT00432809|144531758|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||Chi-squared|||||||0.05
72500750|NCT00432809|144531759|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||||||<0.001
72500751|NCT00432809|144531759|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||||||<0.001
72500752|NCT00432809|144531759|SUPERIORITY_OR_OTHER|||||||0.06||95.0|||||Chi-squared|||||||0.06
72563091|NCT00442546|144658147|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-121.5|STANDARD_ERROR_OF_MEAN|1169.654||0.9341|TWO_SIDED|95.0|-14983.36|14740.362|||ANOVA||Mean Difference (Final Values) = Least Squares Mean Difference|||14740.362|-14983.36|0.9341
72563092|NCT00442546|144658149|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|302.9|STANDARD_ERROR_OF_MEAN|0.0|<|0.0001|TWO_SIDED|95.0|302.9|302.9|||ANOVA||Mean Difference (Final Values) = Least Squares Mean Difference|||302.900|302.900|<0.0001
72620915|NCT00452400|144772833|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.311|STANDARD_ERROR_OF_MEAN|0.056|<|0.0001||95.0|0.201|0.421|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 10 mcg qd minus Placebo|||0.421|0.201|<0.0001
72458900|NCT02367794|144440373|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.93||||0.4007|TWO_SIDED|95.0|0.784|1.102|||Log Rank|||||1.102|0.784|0.4007
72458901|NCT00882050|144440382|OTHER|||||||0.05|||||||Regression, Logistic|||logistic regression|Because we tested interventions against the placebo arm, we increased our subjects to overcome loss of power. 23 per group will provide 80% power assuming a reduced alpha of 0.01 to accommodate the multiple testing issues.|||0.05
72458902|NCT00882050|144440382|SUPERIORITY|Demographic data analyzed with nominal data tested by chi-square, ordinal data by Mann-Whitney, and normal data by t-test. Further, a linear regression analysis to determine the effect of intervention dose on glucose level and typical confounders such as age, weight, and type of surgery was completed. Adverse and SAEs were analyzed by chi-square for occurrence.||||||0.05||||||Due to have 3 trial groups our p value was adjusted for multiple comparisons as a a priori threshold (if a single comparison) was 0.05.|Regression, Logistic|The regression (see above) is a secondary analysis. Groups had been stratified on diabetic (y/n) to balance this potential confounder||Primary t tests of glucose between the 3 groups at 90 minutes post. Secondary MANOVA to determine the effect over time. Change in mean glucose of 20 mg/dl between all groups detectable by 18 subjects per group assuming a SD of 20mg/dl., an 82% power with an alpha of 0.05. Because we tested interventions against the placebo arm, we increased our subjects to overcome loss of power. 23 per group will provide 80% power assuming a reduced alpha of 0.01 to accommodate the multiple testing issues.||||0.05
72458903|NCT00091572|144440392|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.92||||0.2663||95.0|0.8|1.06|||Log Rank||Temozolomide events (progressions/deaths) = 401. Dacarbazine events (progressions/deaths) = 398.|||1.06|0.80|0.2663
72458904|NCT00091572|144440393|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.0||||0.9999||95.0|0.86|1.17|||Log Rank||Temozolomide events (deaths) = 320. Dacarbazine events (deaths) = 325.|||1.17|0.86|0.9999
72458905|NCT00091572|144440394|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.43||||0.0718||95.0|0.97|2.12|||Cochran-Mantel-Haenszel||Temozolomide numerator (responders) = 55. Dacarbazine numerator (responders) = 37.|||2.12|0.97|0.0718
72458906|NCT02591056|144440447|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||t-test, 2 sided|t=+7.45; df=26||||||<0.0001
72458907|NCT01159600|144440448|SUPERIORITY_OR_OTHER||Mean difference|-1.63|STANDARD_ERROR_OF_MEAN|0.24|<|0.0001|TWO_SIDED|97.5|-2.17|-1.08||Each of the hypotheses (10mg vs placebo and 25mg vs placebo) were tested (two-sided test) at the significance level of 0.025.|ANCOVA|ANCOVA with baseline HbA1c and baseline body weight as linear covariates and baseline eGFR, geographical region and treatment as fixed effects|Difference calculated as Met: empa 10mg minus Met: placebo|Null hypothesis: No difference in change from baseline to week 24 in body weight between Empagliflozin 10mg and placebo. A hierarchical testing approach was applied to each of the two dose comparisons (10mg vs placebo and 25mg vs placebo) within each background therapy group (metformin and metformin + SU). If for a specific dose the null hypothesis was rejected for the primary endpoint, the same dose was tested against placebo for the change from baseline in body weight.||-1.08|-2.17|<0.0001
72458908|NCT01159600|144440448|SUPERIORITY_OR_OTHER||Mean difference|-2.01|STANDARD_ERROR_OF_MEAN|0.24|<|0.0001|TWO_SIDED|97.5|-2.56|-1.46||Each of the hypotheses (10mg vs placebo and 25mg vs placebo) were tested (two-sided test) at the significance level of 0.025.|ANCOVA|ANCOVA with baseline HbA1c and baseline body weight as linear covariates and baseline eGFR, geographical region and treatment as fixed effects|Difference calculated as Met: empa 25mg minus Met: placebo|Null hypothesis: No difference in change from baseline to week 24 in body weight between Empagliflozin 25mg and placebo. A hierarchical testing approach was applied to each of the two dose comparisons (10mg vs placebo and 25mg vs placebo) within each background therapy group (metformin and metformin + SU). If for a specific dose the null hypothesis was rejected for the primary endpoint, the same dose was tested against placebo for the change from baseline in body weight.||-1.46|-2.56|<0.0001
72458909|NCT01159600|144440448|SUPERIORITY_OR_OTHER||Mean difference|-1.76|STANDARD_ERROR_OF_MEAN|0.22|<|0.0001|TWO_SIDED|97.5|-2.25|-1.28||Each of the hypotheses (10mg vs placebo and 25mg vs placebo) were tested (two-sided test) at the significance level of 0.025.|ANCOVA|ANCOVA with baseline HbA1c and baseline body weight as linear covariates and baseline eGFR, geographical region and treatment as fixed effects|Difference calculated as Met+SU: empa 10mg minus Met+SU: placebo|Null hypothesis: No difference in change from baseline to week 24 in body weight between Empagliflozin 10mg and placebo. A hierarchical testing approach was applied to each of the two dose comparisons (10mg vs placebo and 25mg vs placebo) within each background therapy group (metformin and metformin + SU). If for a specific dose the null hypothesis was rejected for the primary endpoint, the same dose was tested against placebo for the change from baseline in body weight.||-1.28|-2.25|<0.0001
72458910|NCT01159600|144440448|SUPERIORITY_OR_OTHER||Mean difference|-1.99|STANDARD_ERROR_OF_MEAN|0.22|<|0.0001|TWO_SIDED|97.5|-2.48|-1.5||Each of the hypotheses (10mg vs placebo and 25mg vs placebo) were tested (two-sided test) at the significance level of 0.025.|ANCOVA|ANCOVA with baseline HbA1c and baseline body weight as linear covariates and baseline eGFR, geographical region and treatment as fixed effects|Difference calculated as Met+SU: empa 25mg minus Met+SU: placebo|Null hypothesis: No difference in change from baseline to week 24 in body weight between Empagliflozin 25mg and placebo. A hierarchical testing approach was applied to each of the two dose comparisons (10mg vs placebo and 25mg vs placebo) within each background therapy group (metformin and metformin + SU). If for a specific dose the null hypothesis was rejected for the primary endpoint, the same dose was tested against placebo for the change from baseline in body weight.||-1.50|-2.48|<0.0001
72500753|NCT00432809|144531760|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||||||<0.001
72370502|NCT00488683|144251632|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|0.29||||0.08||95.0|||||Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one month after booster vaccination for the serogroup A||||0.08
72500754|NCT00432809|144531760|SUPERIORITY_OR_OTHER|||||||0.005||95.0|||||Chi-squared|||||||0.005
72370503|NCT00488683|144251632|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|0.05||||0.74||95.0|||||Parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Pearson correlation coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one month after booster vaccination for the serogroup A||||0.74
72370504|NCT00488683|144251632|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|-0.01||||0.94||95.0|||||Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one month after booster vaccination for the serogroup C||||0.94
72500755|NCT00432809|144531760|SUPERIORITY_OR_OTHER|||||||0.004||95.0|||||Chi-squared|||||||0.004
72500756|NCT00432809|144531761|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||||||<0.001
72500757|NCT00432809|144531761|SUPERIORITY_OR_OTHER|||||||0.06||95.0|||||Chi-squared|||||||0.06
72620916|NCT00452400|144772833|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.304|STANDARD_ERROR_OF_MEAN|0.057|<|0.0001||95.0|0.192|0.416|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 20 mcg qd minus Placebo|||0.416|0.192|<0.0001
72458911|NCT01159600|144440449|SUPERIORITY_OR_OTHER||Mean difference|-7.65|STANDARD_ERROR_OF_MEAN|2.74||0.0055|TWO_SIDED|97.5|-13.81|-1.48||Each of the hypotheses (10mg vs placebo and 25mg vs placebo) were tested (two-sided test) at the significance level of 0.025.|ANCOVA|Based on ANCOVA with baseline HbA1c and baseline MDG as linear covariates and baseline eGFR, geographical region and treatment as fixed effects.|Difference calculated as Met: empa 10mg minus Met: placebo|Null hypothesis (H0): No difference in change from baseline to week 24 in MDG between Empa 10mg and placebo. A hierarchical testing approach was applied to each of the two dose comparisons within each background therapy group. If for a specific dose H0 was rejected for the primary endpoint, the same dose was tested against placebo for change from baseline in body weight. If superiority over placebo was shown at this gate level, then testing proceeded to change from baseline in MDG with that dose||-1.48|-13.81|0.0055
72500758|NCT00432809|144531761|SUPERIORITY_OR_OTHER|||||||0.2||95.0|||||Chi-squared|||||||0.20
72500759|NCT00432809|144531762|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||||||<0.001
72500760|NCT00432809|144531762|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||||||<0.001
72500761|NCT00432809|144531762|SUPERIORITY_OR_OTHER|||||||0.2||95.0|||||Chi-squared|||||||0.20
72500762|NCT00432809|144531763|SUPERIORITY_OR_OTHER|||||||0.48||95.0|||||Chi-squared|||||||0.48
72500763|NCT00432809|144531763|SUPERIORITY_OR_OTHER|||||||0.46||95.0|||||Chi-squared|||||||0.46
72500764|NCT00432809|144531763|SUPERIORITY_OR_OTHER|||||||0.06||95.0|||||Chi-squared|||||||0.06
72500765|NCT00432809|144531764|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||||||<0.001
72500766|NCT00432809|144531764|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||||||<0.001
72500767|NCT00432809|144531764|SUPERIORITY_OR_OTHER|||||||0.62||95.0|||||Chi-squared|||||||0.62
72500768|NCT00432809|144531765|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||||||<0.001
72500769|NCT00432809|144531765|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||||||<0.001
72500770|NCT00432809|144531765|SUPERIORITY_OR_OTHER|||||||0.03||95.0|||||Chi-squared|||||||0.03
72500771|NCT01051739|144531768|SUPERIORITY_OR_OTHER|||||||0.21||||||The a priori threshold of statistical significance is p\<0.05|Kaplan Meyer survival curves|||||||.21
72500772|NCT00707577|144531769|SUPERIORITY||||||<|0.05|||||||Regression, Linear|random effects regression models for panel data adjusted for clustering within team||||||<0.05
72500773|NCT00805207|144531797|OTHER|||||||0.85|||||||t-test, 2 sided|||||||0.85
72500774|NCT00805207|144531797|OTHER|||||||0.7|||||||t-test, 2 sided|||||||0.70
72500775|NCT00805207|144531797|OTHER|||||||0.88||||||P-value is the main effect of treatment (i.e., Before vs. After) from ANOVA|ANOVA|VLDL-TG secretion rates were skewed and log transformed prior to performing ANOVA||||||0.88
72500776|NCT00805207|144531797|OTHER|||||||0.26||||||P-value is the main effect of group (i.e., Testosterone, Progesterone, Estrogen and Control) from ANOVA|ANOVA|VLDL-TG secretion rates were skewed and log transformed prior to performing ANOVA||||||0.26
72500777|NCT00805207|144531797|OTHER|||||||0.98||||||P value is the group by treatment interaction from the ANOVA|ANOVA|VLDL-TG secretion rates were skewed and log transformed prior to performing ANOVA||||||0.98
72500778|NCT00805207|144531798|OTHER|||||||0.31|||||||t-test, 2 sided|||||||0.31
72500779|NCT00805207|144531798|OTHER|||||||0.82|||||||t-test, 2 sided|||||||0.82
72500780|NCT00805207|144531798|OTHER||||||<|0.05|||||||ANCOVA|||||||<0.05
72500781|NCT00805207|144531798|OTHER|||||||0.87|||||||ANCOVA|||||||0.87
72500782|NCT00805207|144531798|OTHER|||||||0.57|||||||ANCOVA|||||||0.57
72500783|NCT00805207|144531799|OTHER|||||||0.94|||||||t-test, 2 sided|||||||0.94
72500784|NCT00805207|144531799|OTHER||||||<|0.05|||||||ANCOVA|||||||<0.05
72500785|NCT00805207|144531799|OTHER|||||||0.53|||||||ANCOVA|||||||0.53
72500786|NCT00805207|144531799|OTHER|||||||0.23|||||||ANCOVA|||||||0.23
72500787|NCT00805207|144531800|OTHER|||||||0.8|||||||Wilcoxon (Mann-Whitney)|||||||0.80
72500788|NCT00805207|144531801|OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
72500789|NCT00805207|144531801|OTHER||||||<|0.01||||||P-value is the main effect of treatment (i.e., Before vs. After) from ANOVA|ANOVA|||||||<0.01
72500790|NCT00805207|144531801|OTHER|||||||0.96||||||P-value is the main effect of group (i.e., Testosterone, Progesterone, Estrogen and Control) from ANOVA|ANOVA|||||||0.96
72500791|NCT00805207|144531801|OTHER||||||<|0.05||||||P value is the group by treatment interaction from the ANOVA|ANOVA|||||||<0.05
72500792|NCT00805207|144531801|OTHER||||||<|0.01|||||||Tukey test|||||||<0.01
72500793|NCT00805207|144531801|OTHER||||||<|0.01|||||||Tukey test|||||||<0.01
72500794|NCT00805207|144531801|OTHER||||||>|0.1|||||||Tukey test|||||||>0.10
72500795|NCT00805207|144531801|OTHER||||||>|0.1|||||||Tukey test|||||||>0.10
72500796|NCT00064701|144531802|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin for this study was pre-specified as 10%.|Incidence Difference|-1.9|||||TWO_SIDED|95.2|-8.9|5.2||||||||5.2|-8.9|
72500797|NCT00064701|144531802|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin for this study was pre-specified as 10%.|Incidence Difference|-3.0|||||TWO_SIDED|95.2|-9.9|4.0||||||||4.0|-9.9|
72500798|NCT00064701|144531803|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin for this study was pre-specified as 10%.|Incidence Difference|-3.3|||||TWO_SIDED|95.0|-7.2|0.6||||||||0.6|-7.2|
72500799|NCT00064701|144531803|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin for this study was pre-specified as 10%.|Incidence Difference|0.0|||||TWO_SIDED|95.0|-3.1|3.2||||||||3.2|-3.1|
72500800|NCT00064701|144531804|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin for this study was pre-specified as 10%.|Incidence Difference|-3.8|||||TWO_SIDED|95.0|-8.5|0.9||||||||0.9|-8.5|
72620917|NCT00452400|144772834|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.288|STANDARD_ERROR_OF_MEAN|0.061|<|0.0001||95.0|0.167|0.409|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 2 mcg qd minus Placebo|||0.409|0.167|<0.0001
72458912|NCT01159600|144440449|SUPERIORITY_OR_OTHER||Mean difference|-12.37|STANDARD_ERROR_OF_MEAN|2.75|<|0.0001|TWO_SIDED|97.5|-18.55|-6.19||Each of the hypotheses (10mg vs placebo and 25mg vs placebo) were tested (two-sided test) at the significance level of 0.025.|ANCOVA|Based on ANCOVA with baseline HbA1c and baseline MDG as linear covariates and baseline eGFR, geographical region and treatment as fixed effects.|Difference calculated as Met: empa 25mg minus Met: placebo|Null hypothesis (H0): No difference in change from baseline to week 24 in MDG between Empa 25mg and placebo. A hierarchical testing approach was applied to each of the two dose comparisons within each background therapy group. If for a specific dose H0 was rejected for the primary endpoint, the same dose was tested against placebo for change from baseline in body weight. If superiority over placebo was shown at this gate level, then testing proceeded to change from baseline in MDG with that dose||-6.19|-18.55|<0.0001
72458913|NCT01159600|144440449|SUPERIORITY_OR_OTHER||Mean difference|-10.02|STANDARD_ERROR_OF_MEAN|2.53|<|0.0001|TWO_SIDED|97.5|-15.72|-4.32||Each of the hypotheses (10mg vs placebo and 25mg vs placebo) were tested (two-sided test) at the significance level of 0.025.|ANCOVA|Based on ANCOVA with baseline HbA1c and baseline MDG as linear covariates and baseline eGFR, geographical region and treatment as fixed effects.|Difference calculated as Met+SU: empa 10mg minus Met+SU: placebo|Null hypothesis (H0): No difference in change from baseline to week 24 in MDG between Empa 10mg and placebo. A hierarchical testing approach was applied to each of the two dose comparisons within each background therapy group. If for a specific dose H0 was rejected for the primary endpoint, the same dose was tested against placebo for change from baseline in body weight. If superiority over placebo was shown at this gate level, then testing proceeded to change from baseline in MDG with that dose||-4.32|-15.72|<0.0001
72458914|NCT01159600|144440449|SUPERIORITY_OR_OTHER||Mean difference|-13.06|STANDARD_ERROR_OF_MEAN|2.7|<|0.0001|TWO_SIDED|97.5|-19.15|-6.98||Each of the hypotheses (10mg vs placebo and 25mg vs placebo) were tested (two-sided test) at the significance level of 0.025.|ANCOVA|Based on ANCOVA with baseline HbA1c and baseline MDG as linear covariates and baseline eGFR, geographical region and treatment as fixed effects.|Difference calculated as Met+SU: empa 25mg minus Met+SU: placebo|Null hypothesis (H0): No difference in change from baseline to week 24 in MDG between Empa 25mg and placebo. A hierarchical testing approach was applied to each of the two dose comparisons within each background therapy group. If for a specific dose H0 was rejected for the primary endpoint, the same dose was tested against placebo for change from baseline in body weight. If superiority over placebo was shown at this gate level, then testing proceeded to change from baseline in MDG with that dose||-6.98|-19.15|<0.0001
72458915|NCT01159600|144440450|SUPERIORITY_OR_OTHER||Mean difference|-0.57|STANDARD_ERROR_OF_MEAN|0.07|<|0.0001|TWO_SIDED|97.5|-0.72|-0.42||Each of the hypotheses (10mg vs placebo and 25mg vs. placebo) were tested (two-sided test) at the significance level of 0.025.|ANCOVA|Based on ANCOVA with baseline HbA1c as a linear covariate and baseline eGFR (renal function), geographical region and treatment as fixed effects.|Difference calculated as Met: empa 10mg minus Met: placebo|Null hypothesis: No difference in change from baseline to week 24 in HbA1c between Empagliflozin 10mg and placebo. The study consisted of two substudies as defined by the two background medications 'metformin' and 'metformin + SU'. Within each group of background medication, each of the two hypotheses (10mg vs placebo and 25mg vs. placebo) was tested in a two-sided test.||-0.42|-0.72|<0.0001
72458916|NCT01159600|144440450|SUPERIORITY_OR_OTHER||Mean difference|-0.64|STANDARD_ERROR_OF_MEAN|0.07|<|0.0001|TWO_SIDED|97.5|-0.79|-0.48||Each of the hypotheses (10mg vs placebo and 25mg vs. placebo) were tested (two-sided test) at the significance level of 0.025.|ANCOVA|Based on ANCOVA with baseline HbA1c as a linear covariate and baseline eGFR, geographical region and treatment as fixed effects.|Difference calculated as Met: empa 25mg minus Met: placebo|Null hypothesis: No difference in change from baseline to week 24 in HbA1c between Empagliflozin 25mg and placebo. The study consisted of two substudies as defined by the two background medications 'metformin' and 'metformin + SU'. Within each group of background medication, each of the two hypotheses (10mg vs placebo and 25mg vs. placebo) was tested in a two-sided test.||-0.48|-0.79|<0.0001
72458917|NCT01159600|144440450|SUPERIORITY_OR_OTHER||Mean difference|-0.64|STANDARD_ERROR_OF_MEAN|0.07|<|0.0001|TWO_SIDED|97.5|-0.79|-0.49||Each of the hypotheses (10mg vs placebo and 25mg vs. placebo) were tested (two-sided test) at the significance level of 0.025.|ANCOVA|Based on ANCOVA with baseline HbA1c as a linear covariate and baseline eGFR, geographical region and treatment as fixed effects.|Difference calculated as Met+SU: empa 10mg minus Met+SU: placebo|Null hypothesis: No difference in change from baseline to week 24 in HbA1c between Empagliflozin 10mg and placebo. The study consisted of two substudies as defined by the two background medications 'metformin' and 'metformin + SU'. Within each group of background medication, each of the two hypotheses (10mg vs placebo and 25mg vs. placebo) was tested in a two-sided test.||-0.49|-0.79|<0.0001
72458918|NCT01159600|144440450|SUPERIORITY_OR_OTHER||Mean difference|-0.59|STANDARD_ERROR_OF_MEAN|0.07|<|0.0001|TWO_SIDED|97.5|-0.74|-0.44||Each of the hypotheses (10mg vs placebo and 25mg vs. placebo) were tested (two-sided test) at the significance level of 0.025.|ANCOVA|Based on ANCOVA with baseline HbA1c as a linear covariate and baseline eGFR, geographical region and treatment as fixed effects.|Difference calculated as Met+SU: empa 25mg minus Met+SU: placebo|Null hypothesis: No difference in change from baseline to week 24 in HbA1c between Empagliflozin 25mg and placebo. The study consisted of two substudies as defined by the two background medications 'metformin' and 'metformin + SU'. Within each group of background medication, each of the two hypotheses (10mg vs placebo and 25mg vs. placebo) was tested in a two-sided test.||-0.44|-0.74|<0.0001
72458919|NCT01366976|144440457|SUPERIORITY_OR_OTHER|||||||0.05|TWO_SIDED||||||Mixed Models Analysis|||We hypothesized that acetaminophen would reduce peak isofuran concentrations by 22 pg/mL (40% reduction from peak concentrations). If the true difference in the acetaminophen and placebo group means is 22 pg/mL (SD=30 pg/mL), we would need to study 30 experimental subjects and 30 control subjects to be able to reject the null hypothesis that the population means of the acetaminophen and placebo groups are equal with probability (power) 0.8.||||0.05
72458920|NCT01366976|144440459|SUPERIORITY_OR_OTHER|||||||0.12|TWO_SIDED||||||Mixed Models Analysis|||||||0.12
72500801|NCT00064701|144531804|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin for this study was pre-specified as 10%.|Incidence Difference|0.0|||||TWO_SIDED|95.0|-4.0|4.1||||||||4.1|-4.0|
72370505|NCT00488683|144251632|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|-0.09||||0.51||95.0|||||Parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Pearson correlation coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one month after booster vaccination for the serogroup C||||0.51
72458921|NCT00307489|144440461|SUPERIORITY_OR_OTHER|||||||0.544||95.0||||P-values were from a Cochran-Mantel-Haenszel test, controlling for baseline HBeAg status and prior lamivudine use.|Cochran-Mantel-Haenszel|||||||.544
72458922|NCT00307489|144440462|SUPERIORITY_OR_OTHER|||||||0.208||95.0||||Controlling for baseline HBeAg status and prior lamivudine use.|van Elteren|||||||0.208
72458923|NCT00307489|144440463|SUPERIORITY_OR_OTHER|||||||0.712||95.0||||Controlling for baseline HBeAg and prior lamivudine use.|van Elteren|||||||0.712
72458924|NCT00307489|144440464|SUPERIORITY_OR_OTHER|||||||0.988||95.0||||Controlling for baseline HBeAg status and prior lamivudine use.|Cochran-Mantel-Haenszel|||||||0.988
72458925|NCT00307489|144440465|SUPERIORITY_OR_OTHER|||||||0.423||95.0||||Controlling for baseline HBeAg status and prior lamivudine use|Cochran-Mantel-Haenszel|||||||0.423
72458926|NCT00307489|144440466|SUPERIORITY_OR_OTHER|||||||0.109||95.0||||Controlling for baseline HBeAg status and prior lamivudine use.|Cochran-Mantel-Haenszel|||||||0.109
72458927|NCT00307489|144440467|SUPERIORITY_OR_OTHER|||||||0.952||95.0|||||Cochran-Mantel-Haenszel|Controlling for baseline HBeAg and prior lamivudine use.||||||0.952
72458928|NCT00307489|144440468|SUPERIORITY_OR_OTHER|||||||0.655||95.0||||Controlling for baseline HBeAg status and prior lamivudine use.|Cochran-Mantel-Haenszel|||||||0.655
72458929|NCT00307489|144440469|SUPERIORITY_OR_OTHER|||||||0.401||95.0||||Controlling for baseline HBeAg status and prior lamivudine use.|Cochran-Mantel-Haenszel|||||||0.401
72458930|NCT00307489|144440470|SUPERIORITY_OR_OTHER|||||||0.401||95.0||||Controlling for baseline HBeAg status and prior lamivudine use.|Cochran-Mantel-Haenszel|||||||0.401
72458931|NCT00307489|144440471|SUPERIORITY_OR_OTHER|||||||0.103||95.0||||Controlling for baseline HBeAg status and prior lamivudine use.|van Elteren|||||||0.103
72458932|NCT00307489|144440472|SUPERIORITY_OR_OTHER|||||||0.999||95.0||||Controlling for baseline HBeAg status and prior lamivudine use.|van Elteren|||||||0.999
72458933|NCT00307489|144440473|SUPERIORITY_OR_OTHER|||||||0.781||95.0||||Controlling for baseline HBeAg status and prior lamivudine use.|Cochran-Mantel-Haenszel|||||||0.781
72458934|NCT00307489|144440474|SUPERIORITY_OR_OTHER|||||||0.936||95.0||||Controlling for baseline HBeAg status and prior lamivudine use.|Cochran-Mantel-Haenszel|||||||0.936
72458935|NCT00307489|144440475|SUPERIORITY_OR_OTHER|||||||0.784||95.0||||Controlling for baseline HBeAg status and prior lamivudine use.|Cochran-Mantel-Haenszel|||||||0.784
72458936|NCT00307489|144440476|SUPERIORITY_OR_OTHER|||||||0.703||95.0||||Controlling for baseline HBeAg status and prior lamivudine use.|Cochran-Mantel-Haenszel|||||||0.703
72458937|NCT00307489|144440477|SUPERIORITY_OR_OTHER|||||||0.254||95.0||||Controlling for baseline HBeAg status and prior lamivudine use.|Cochran-Mantel-Haenszel|||||||0.254
72458938|NCT00307489|144440478|SUPERIORITY_OR_OTHER|||||||0.254||95.0||||Controlling for baseline HBeAg status and prior lamivudine use.|Cochran-Mantel-Haenszel|||||||0.254
72458939|NCT00307489|144440479|SUPERIORITY_OR_OTHER|||||||0.878||95.0|||||Cochran-Mantel-Haenszel|||||||0.878
72458940|NCT01690000|144440480|SUPERIORITY_OR_OTHER||||||<|0.05||||||The p-value was calculated|t-test, 2 sided|||The p-value was calculated||||<0.05
72458941|NCT04540952|144440500|SUPERIORITY|Power analysis indicated that with a sample size of 34 per arm, would provide 81% power to detect an effect size of 0.7 (0.7\*SD of fluid deficit) with a two-sided, two sample t test (a=0.05).|Mean Difference (Final Values)|11.3||||0.93|TWO_SIDED|95.0|-260.7|283.4|||t-test, 2 sided|||||283.4|-260.7|0.93
72458942|NCT00949234|144440526|OTHER||||||<|0.05|||||||Chi-squared|||There was no power calculation for this analysis. The study was mainly descriptive, but Chi-square tests were used to determine if there were differences between individuals who were retained at the 24 Week Follow-up visit from individuals who were not retained at the 24 Week Follow-up visit.||||<0.05
72458943|NCT02291861|144440536|SUPERIORITY||LSM difference|-1.9||||0.001|TWO_SIDED|95.0|-3.09|-0.79||Treatment group, visit, treatment group-by-visit interaction, and baseline use of DRAs as fixed effects and the baseline value as a covariate. The model was fit using an unstructured covariance structure.|mixed model for repeated measures||SD-809 - placebo|"A hierarchical (fixed-sequence) testing approach was used for the analysis of the primary and key secondary endpoints to maintain the experiment-wise type I error rate of 5%.~The primary endpoint compared the change in total motor AIMS score from baseline to week 12 between the SD-809 36 mg/day group and the placebo group."||-0.79|-3.09|0.001
72458944|NCT02291861|144440536|SUPERIORITY||LSM difference|-1.8||||0.003|TWO_SIDED|95.0|-3.0|-0.63||Treatment group, visit, treatment group-by-visit interaction, and baseline use of DRAs as fixed effects and the baseline value as a covariate. The model was fit using an unstructured covariance structure.|mixed model for repeated measures||SD-809 - placebo|"A hierarchical (fixed-sequence) testing approach was used for the analysis of the primary and key secondary endpoints to maintain the experiment-wise type I error rate of 5%.~This key secondary endpoint compared the change in total motor AIMS score from baseline to week 12 between the SD-809 24 mg/day group and the placebo group, and is the third analysis in the fixed-sequence."||-0.63|-3.00|0.003
72458945|NCT02291861|144440536|SUPERIORITY||LSM difference|-0.7||||0.217|TWO_SIDED|95.0|-1.84|0.42||Treatment group, visit, treatment group-by-visit interaction, and baseline use of DRAs as fixed effects and the baseline value as a covariate. The model was fit using an unstructured covariance structure.|mixed model for repeated measures||SD-809 - placebo|"A hierarchical (fixed-sequence) testing approach was used for the analysis of the primary and key secondary endpoints to maintain the experiment-wise type I error rate of 5%.~This key secondary endpoint compared the change in total motor AIMS score from baseline to week 12 between the SD-809 12 mg/day group and the placebo group, and is the fifth analysis in the fixed-sequence."||0.42|-1.84|0.217
72458946|NCT02291861|144440537|SUPERIORITY||Odds Ratio (OR)|2.11||||0.059|TWO_SIDED|95.0|0.96|4.645|||Cochran-Mantel-Haenszel|The statistical test was a Cochran-Mantel-Haenszel (CMH) test stratified by baseline use of dopamine receptor antagonist (DRAs).|SD-809/placebo The odds ratio was the Mantel-Haenszel estimate of the common odds ratio.|"A hierarchical (fixed-sequence) testing approach was used for the analysis of the primary and key secondary endpoints to maintain the experiment-wise type I error rate of 5%.~This key secondary endpoint compared the percentage of patients considered a treatment success at week 12 between the SD-809 36 mg/day group and the placebo group, and is the second analysis in the fixed-sequence."||4.645|0.960|0.059
72470070|NCT01124838|144464405|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference|1.88||||0.401|TWO_SIDED|95.0|-2.53|6.29|||ANOVA|From ANOVA of change from baseline to final/early termination visit with treatment as a factor.||The statistical test for the ranked secondary variables was carried out in hierarchical order at the significance level of 5%.||6.29|-2.53|0.401
72458947|NCT02291861|144440537|SUPERIORITY||Odds Ratio (OR)|2.71||||0.014|TWO_SIDED|95.0|1.211|6.052|||Cochran-Mantel-Haenszel|The statistical test was a CMH test stratified by baseline use of DRAs.|SD-809/placebo The odds ratio was the Mantel-Haenszel estimate of the common odds ratio.|"A hierarchical (fixed-sequence) testing approach was used for the analysis of the primary and key secondary endpoints to maintain the experiment-wise type I error rate of 5%.~This key secondary endpoint compared the percentage of patients considered a treatment success at week 12 between the SD-809 24 mg/day group and the placebo group, and is the fourth analysis in the fixed-sequence."||6.052|1.211|0.014
72458948|NCT02291861|144440537|SUPERIORITY||Odds Ratio (OR)|1.15||||0.734|TWO_SIDED|95.0|0.509|2.61|||Cochran-Mantel-Haenszel|The statistical test was a CMH test stratified by baseline use of DRAs.|SD-809/placebo The odds ratio was the Mantel-Haenszel estimate of the common odds ratio.|"A hierarchical (fixed-sequence) testing approach was used for the analysis of the primary and key secondary endpoints to maintain the experiment-wise type I error rate of 5%.~This key secondary endpoint compared the percentage of patients considered a treatment success at week 12 between the SD-809 12 mg/day group and the placebo group, and is the sixth (last) analysis in the fixed-sequence."||2.610|0.509|0.734
72458949|NCT02291861|144440538|SUPERIORITY||LSM difference|-3.6||||0.207|TWO_SIDED|95.0|-9.18|2.0||5% level of significance (2-sided)|ANCOVA|The statistical model was an ANCOVA with treatment group and baseline use of DRAs as fixed effects and the baseline value as a covariate.|SD-809 - placebo|||2.00|-9.18|0.207
72458950|NCT02291861|144440538|SUPERIORITY||LSM difference|-3.1||||0.281|TWO_SIDED|95.0|-8.86|2.59||5% level of significance (2-sided)|ANCOVA|The statistical model was an ANCOVA with treatment group and baseline use of DRAs as fixed effects and the baseline value as a covariate.|SD-809 - placebo|||2.59|-8.86|0.281
72458951|NCT02291861|144440538|SUPERIORITY||LSM difference|1.3||||0.627|TWO_SIDED|95.0|-4.1|6.79||5% level of significance (2-sided)|ANCOVA|The statistical model was an ANCOVA with treatment group and baseline use of DRAs as fixed effects and the baseline value as a covariate.|SD-809 - placebo|||6.79|-4.10|0.627
72620918|NCT00452400|144772834|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.28|STANDARD_ERROR_OF_MEAN|0.062|<|0.0001||95.0|0.159|0.401|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 5 mcg qd minus Placebo|||0.401|0.159|<0.0001
72458952|NCT02291861|144440539|SUPERIORITY||Odds Ratio (OR)|1.51||||0.296|TWO_SIDED|95.0|0.694|3.285||5% level of significance (2-sided)|Cochran-Mantel-Haenszel|The statistical test was a CMH test stratified by baseline use of DRAs.|SD-809/placebo The odds ratio was the Mantel-Haenszel estimate of the common odds ratio.|||3.285|0.694|0.296
72458953|NCT02291861|144440539|SUPERIORITY||Odds Ratio (OR)|1.82||||0.134|TWO_SIDED|95.0|0.826|3.994||5% level of significance (2-sided)|Cochran-Mantel-Haenszel|The statistical test was a CMH test stratified by baseline use of DRAs.|SD-809/placebo The odds ratio was the Mantel-Haenszel estimate of the common odds ratio.|||3.994|0.826|0.134
72458954|NCT02291861|144440539|SUPERIORITY||Odds Ratio (OR)|0.69||||0.372|TWO_SIDED|95.0|0.302|1.563||5% level of significance (2-sided)|Cochran-Mantel-Haenszel|The statistical test was a CMH test stratified by baseline use of DRAs.|SD-809/placebo The odds ratio was the Mantel-Haenszel estimate of the common odds ratio.|||1.563|0.302|0.372
72458955|NCT02291861|144440540|SUPERIORITY||Odds Ratio (OR)|3.8||||0.007|TWO_SIDED|95.0|1.395|10.359||5% level of significance (2-sided)|Cochran-Mantel-Haenszel|The statistical test was a CMH test stratified by baseline use of DRAs.|SD-809/placebo The odds ratio was the Mantel-Haenszel estimate of the common odds ratio.|||10.359|1.395|0.007
72458956|NCT02291861|144440540|SUPERIORITY||Odds Ratio (OR)|3.96||||0.005|TWO_SIDED|95.0|1.46|10.716||5% level of significance (2-sided)|Cochran-Mantel-Haenszel|The statistical test was a CMH test stratified by baseline use of DRAs.|SD-809/placebo The odds ratio was the Mantel-Haenszel estimate of the common odds ratio.|||10.716|1.460|0.005
72458957|NCT02291861|144440540|SUPERIORITY||Odds Ratio (OR)|1.13||||0.829|TWO_SIDED|95.0|0.383|3.316||5% level of significance (2-sided)|Cochran-Mantel-Haenszel|The statistical test was a CMH test stratified by baseline use of DRAs.|SD-809/placebo The odds ratio was the Mantel-Haenszel estimate of the common odds ratio.|||3.316|0.383|0.829
72458958|NCT02291861|144440541|SUPERIORITY||Mean Difference (Final Values)|-21.5|||<|0.001|TWO_SIDED|95.0|-33.44|-9.52||5% level of significance (2-sided). Treatment group, visit, treatment group-by-visit interaction, and baseline use of DRAs as fixed effects and the baseline value as a covariate. The model was fit using an unstructured covariance structure.|mixed model for repeated measures||SD-809 - placebo|||-9.52|-33.44|<0.001
72458959|NCT02291861|144440541|SUPERIORITY||Mean Difference (Final Values)|-20.2||||0.001|TWO_SIDED|95.0|-32.57|-7.92||5% level of significance (2-sided). Treatment group, visit, treatment group-by-visit interaction, and baseline use of DRAs as fixed effects and the baseline value as a covariate. The model was fit using an unstructured covariance structure.|mixed model for repeated measures||SD-809 - placebo|||-7.92|-32.57|0.001
72458960|NCT02291861|144440541|SUPERIORITY||Mean Difference (Final Values)|-8.4||||0.16|TWO_SIDED|95.0|-20.15|3.34||5% level of significance (2-sided). Treatment group, visit, treatment group-by-visit interaction, and baseline use of DRAs as fixed effects and the baseline value as a covariate. The model was fit using an unstructured covariance structure.|mixed model for repeated measures||SD-809 - placebo|||3.34|-20.15|0.160
72458961|NCT02823574|144440549|SUPERIORITY||Odds Ratio (OR)|0.68||||0.2897|TWO_SIDED|95.5|0.33|1.43|||Mantel Haenszel|||Treatment A over Treatment B||1.43|0.33|0.2897
72458962|NCT02823574|144440554|SUPERIORITY||Hazard Ratio (HR)|1.05|||||TWO_SIDED|95.0|0.78|1.41|||||computed using a cox proportional hazard model stratified by randomization PD-L1 and HPV status|||1.41|0.78|
72458963|NCT02823574|144440555|SUPERIORITY||Hazard Ratio (HR)|1.05|||||TWO_SIDED|95.0|0.78|1.41|||||computed using a cox proportional hazard model stratified by randomization PDL-1 and HPV status|||1.41|0.78|
72458964|NCT02823574|144440556|SUPERIORITY||Hazard Ratio (HR)|1.09|||||TWO_SIDED|95.0|0.87|1.36|||||computed using a cox proportional hazard model stratified by randomization PDL-1 and HPV status|||1.36|0.87|
72458965|NCT02823574|144440557|SUPERIORITY||Hazard Ratio (HR)|1.08|||||TWO_SIDED|95.0|0.81|1.45|||||computed using a cox proportional hazard model stratified by randomization PDL-1 and HPV status|||1.45|0.81|
72620919|NCT00452400|144772834|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.297|STANDARD_ERROR_OF_MEAN|0.061|<|0.0001||95.0|0.178|0.416|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 10 mcg qd minus Placebo|||0.416|0.178|<0.0001
72500802|NCT00064701|144531805|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin for this study was pre-specified as 10%.|Incidence Difference at 6 Months|-8.0|||||TWO_SIDED|95.0|-13.1|-3.0||||||Comparison of tacrolimus with cyclosporine at 6 months||-3.0|-13.1|
72458966|NCT02823574|144440558|SUPERIORITY||Hazard Ratio (HR)|1.14|||||TWO_SIDED|95.0|0.81|1.61|||||computed using a cox proportional hazard model stratified by randomization PDL-1 and HPV status|||1.61|0.81|
72500803|NCT00064701|144531805|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin for this study was pre-specified as 10%.|Incidence Difference at 6 Months|-3.8|||||TWO_SIDED|95.0|-9.5|1.8||||||Comparison of Tacrolimus Modified Release with Cyclosporine at 6 months||1.8|-9.5|
72458967|NCT02823574|144440583|SUPERIORITY||Odds Ratio (OR)|0.64|||||TWO_SIDED|95.0|0.32|1.29|||Mantel Haenszel|||Treatment A over Treatment B||1.29|0.32|
72458968|NCT03845517|144440603|SUPERIORITY||Risk Difference (RD)|-7.5||||0.8076|TWO_SIDED|95.0|-24.5|9.5||One sided p-value.|Cochran-Mantel-Haenszel|||||9.5|-24.5|0.8076
72458969|NCT03845517|144440603|SUPERIORITY||Risk Difference (RD)|5.2||||0.2189|TWO_SIDED|95.0|-7.9|18.3||One sided p-value.|Cochran-Mantel-Haenszel|||||18.3|-7.9|0.2189
72458970|NCT03845517|144440603|SUPERIORITY||Risk Difference (RD)|1.7||||0.401|TWO_SIDED|95.0|-11.8|15.3||One sided p-value.|Cochran-Mantel-Haenszel|||||15.3|-11.8|0.4010
72458971|NCT03845517|144440604|SUPERIORITY||Risk Difference (RD)|-2.1||||0.595|TWO_SIDED|95.0|-19.1|14.9||One sided p-value.|Cochran-Mantel-Haenszel|||||14.9|-19.1|0.5950
72458972|NCT03845517|144440604|SUPERIORITY||Risk Difference (RD)|8.6||||0.1125|TWO_SIDED|95.0|-5.3|22.6||One sided p-value.|Cochran-Mantel-Haenszel|||||22.6|-5.3|0.1125
72500804|NCT00064701|144531805|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin for this study was pre-specified as 10%.|Incidence Difference at 12 Months|-6.1|||||TWO_SIDED|95.0|-12.0|-0.3||||||Comparison of tacrolimus with cyclosporine at 12 months||-0.3|-12.0|
72563093|NCT00442546|144658153|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.121|STANDARD_ERROR_OF_MEAN|0.087||0.1661||95.0|-0.293|0.051|||ANOVA||Mean difference (final values) = Least squares mean difference|24 hours||0.051|-0.293|0.1661
72620920|NCT00452400|144772834|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.286|STANDARD_ERROR_OF_MEAN|0.062|<|0.0001||95.0|0.164|0.407|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 20 mcg qd minus Placebo|||0.407|0.164|<0.0001
72620921|NCT00452400|144772835|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.133|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001||95.0|0.09|0.176|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 2 mcg qd minus Placebo|||0.176|0.090|<0.0001
72458973|NCT03845517|144440604|SUPERIORITY||Risk Difference (RD)|9.6||||0.0891|TWO_SIDED|95.0|-4.4|23.6||One sided p-value.|Cochran-Mantel-Haenszel|||||23.6|-4.4|0.0891
72500805|NCT00064701|144531805|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin for this study was pre-specified as 10%.|Incidence Difference at 12 months|-3.4|||||TWO_SIDED|95.0|-9.6|2.8||||||Comparison of Tacrolimus Modified Release with Cyclosporine at 12 months||2.8|-9.6|
72500806|NCT00064701|144531815|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5|||||TWO_SIDED|95.0|-6.5|5.5||||||||5.5|-6.5|
72500807|NCT00064701|144531815|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.5|||||TWO_SIDED|95.0|-3.9|6.9||||||||6.9|-3.9|
72458974|NCT00257309|144440665|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.69||||0.21|TWO_SIDED|95.0|0.38|1.23||Unadjusted analysis|Chi-squared|||||1.23|0.38|0.21
72458975|NCT02009332|144440666|OTHER||maximum deliverable dose (MDD)|400.0|||||TWO_SIDED||||||||Maximum deliverable dose (MDD) was not reached in the Phase 1 study as no DLTs were observed in any of the dose groups up to ABI-009 400 mg/week.|||||
72458976|NCT03386344|144440674|SUPERIORITY||Difference in Least Squares (LS) Means|-0.45|STANDARD_ERROR_OF_MEAN|0.102|<|0.0001|TWO_SIDED|95.0|-0.649|-0.25|||ANCOVA|||The change from baseline to Week 26 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of sex (male, female), and country as fixed effects, and baseline HbA1c as a covariate.||-0.250|-0.649|<0.0001
72458977|NCT03386344|144440674|SUPERIORITY||Difference in LS Means|-0.43|STANDARD_ERROR_OF_MEAN|0.102|<|0.0001|TWO_SIDED|95.0|-0.634|-0.235|||ANCOVA|||The change from baseline to Week 26 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of sex (male, female), and country as fixed effects, and baseline HbA1c as a covariate.||-0.235|-0.634|<0.0001
72458978|NCT03386344|144440675|SUPERIORITY||Difference in LS Means|-0.24|STANDARD_ERROR_OF_MEAN|0.423||0.5707|TWO_SIDED|95.0|-1.07|0.59|||ANCOVA|||Percent change from baseline to Week 26 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of sex (male, female), and country as fixed effects, and baseline BMD as a covariate.||0.590|-1.070|0.5707
72458979|NCT03386344|144440675|SUPERIORITY||Difference in LS Means|-0.15|STANDARD_ERROR_OF_MEAN|0.419||0.7247|TWO_SIDED|95.0|-0.969|0.674|||ANCOVA|||Percent change from baseline to Week 26 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of sex (male, female), and country as fixed effects, and baseline BMD as a covariate.||0.674|-0.969|0.7247
72500808|NCT00064701|144531816|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.3|||||TWO_SIDED|95.0|-9.1|6.6||||||||6.6|-9.1|
72500809|NCT00064701|144531816|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.8|||||TWO_SIDED|95.0|-7.1|8.6||||||||8.6|-7.1|
72500810|NCT02249052|144531817|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-83.33|STANDARD_DEVIATION|25.0311|<|0.0001|TWO_SIDED|95.0|-95.394|-71.265|||t-test, 2 sided|||||-71.265|-95.394|<0.0001
72500811|NCT02249052|144531818|SUPERIORITY_OR_OTHER||Binomial proportion|0.8947|||<|0.0001|TWO_SIDED|95.0|0.6686|0.987|||Sign test|||||.9870|.6686|<.0001
72500812|NCT04325503|144531963|OTHER|A comparison is not being made between two different treatment groups.|Mean Difference (Net)|0.0905||||0.015|TWO_SIDED|95.0|0.022|0.159||A priori threshold statistical significance p \< 0.05|t-test, 2 sided|Paired samples t-test, df = 9||||0.159|0.022|0.015
72563094|NCT00442546|144658153|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.081|STANDARD_ERROR_OF_MEAN|0.088||0.3604||95.0|-0.254|0.093|||ANOVA||Mean difference (final values) = Least squares mean difference|24 hours||0.093|-0.254|0.3604
72563095|NCT00442546|144658153|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.126|STANDARD_ERROR_OF_MEAN|0.083||0.1299||95.0|-0.29|0.037|||ANOVA||Mean difference (final values) = Least squares mean difference|48 hours||0.037|-0.290|0.1299
72458980|NCT03386344|144440676|SUPERIORITY||Difference in LS Means|0.14|STANDARD_ERROR_OF_MEAN|0.308||0.6454|TWO_SIDED|95.0|-0.462|0.745|||ANCOVA|||Percent change from baseline to Week 26 was analyzed using ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of sex (male, female), and country as fixed effects, and baseline lumbar spine as a covariate.||0.745|-0.462|0.6454
72458981|NCT03386344|144440676|SUPERIORITY||Difference in LS Means|0.19|STANDARD_ERROR_OF_MEAN|0.308||0.5289|TWO_SIDED|95.0|-0.41|0.798|||ANCOVA|||Percent change from baseline to Week 26 was analyzed using ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of sex (male, female), and country as fixed effects, and baseline lumbar spine as a covariate.||0.798|-0.410|0.5289
72563096|NCT00442546|144658153|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.129|STANDARD_ERROR_OF_MEAN|0.082||0.1167||95.0|-0.29|0.032|||ANOVA||Mean difference (final values) = Least squares mean difference|48 hours||0.032|-0.290|0.1167
72563097|NCT00442546|144658153|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.057|STANDARD_ERROR_OF_MEAN|0.09||0.5271||95.0|-0.234|0.12|||ANOVA||Mean difference (final values) = Least squares mean difference|72 hours||0.120|-0.234|0.5271
72563098|NCT00442546|144658153|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.038|STANDARD_ERROR_OF_MEAN|0.09||0.6731||95.0|-0.215|0.139|||ANOVA||Mean difference (final values) = Least squares mean difference|72 hours||0.139|-0.215|0.6731
72563099|NCT00442546|144658153|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.053|STANDARD_ERROR_OF_MEAN|0.098||0.5936||95.0|-0.247|0.142|||ANOVA||Mean difference (final values) = Least squares mean difference|96 hours||0.142|-0.247|0.5936
72620922|NCT00452400|144772835|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.172|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001||95.0|0.128|0.215|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 5 mcg qd minus Placebo|||0.215|0.128|<0.0001
72458982|NCT03386344|144440677|SUPERIORITY||Difference in LS Means|0.75|STANDARD_ERROR_OF_MEAN|0.462||0.105|TWO_SIDED|95.0|-0.157|1.654|||ANCOVA|||Percent change from baseline to Week 26 was analyzed using ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of sex (male, female), and country as fixed effects, and baseline BMD as a covariate.||1.654|-0.157|0.1050
72458983|NCT03386344|144440677|SUPERIORITY||Difference in LS Means|0.32|STANDARD_ERROR_OF_MEAN|0.46||0.4804|TWO_SIDED|95.0|-0.577|1.226|||ANCOVA|||Percent change from baseline to Week 26 was analyzed using ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of sex (male, female), and country as fixed effects, and baseline BMD as a covariate.||1.226|-0.577|0.4804
72458984|NCT03386344|144440678|SUPERIORITY||Difference in LS Means|-1.91|STANDARD_ERROR_OF_MEAN|0.336|<|0.0001|TWO_SIDED|95.0|-2.568|-1.252|||ANCOVA|||The change from baseline to Week 26 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of sex (male, female), and country as fixed effects, and baseline body weight as a covariate.||-1.252|-2.568|<0.0001
72458985|NCT03386344|144440678|SUPERIORITY||Difference in LS Means|-1.7|STANDARD_ERROR_OF_MEAN|0.335|<|0.0001|TWO_SIDED|95.0|-2.36|-1.046|||ANCOVA|||The change from baseline to Week 26 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of sex (male, female), and country as fixed effects, and baseline body weight as a covariate.||-1.046|-2.360|<0.0001
72458986|NCT03386344|144440679|SUPERIORITY||Difference in LS Means|-18.891|STANDARD_ERROR_OF_MEAN|4.5766|<|0.0001|TWO_SIDED|95.0|-27.8605|-9.9205|||ANCOVA|||The change from baseline to Week 26 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of sex (male, female), and country as fixed effects, baseline fasting plasma glucose as a covariate.||-9.9205|-27.8605|<0.0001
72458987|NCT03386344|144440679|SUPERIORITY||Difference in LS Means|-21.333|STANDARD_ERROR_OF_MEAN|4.5902|<|0.0001|TWO_SIDED|95.0|-30.3294|-12.336|||ANCOVA|||The change from baseline to Week 26 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of sex (male, female), and country as fixed effects, baseline fasting plasma glucose as a covariate.||-12.3360|-30.3294|<0.0001
72458988|NCT03386344|144440680|SUPERIORITY||Difference in LS Means|-0.8|STANDARD_ERROR_OF_MEAN|1.48||0.5864|TWO_SIDED|95.0|-3.705|2.095|||ANCOVA|||The change from baseline to Week 12 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of sex (male, female), and country as fixed effects, and baseline SBP as a covariate.||2.095|-3.705|0.5864
72458989|NCT03386344|144440680|SUPERIORITY||Difference in LS Means|-1.16|STANDARD_ERROR_OF_MEAN|1.478||0.4315|TWO_SIDED|95.0|-4.058|1.734|||ANCOVA|||The change from baseline to Week 12 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of sex (male, female), and country as fixed effects, and baseline SBP as a covariate.||1.734|-4.058|0.4315
72458990|NCT03386344|144440681|SUPERIORITY||Percentage Difference|10.5||||0.0172|TWO_SIDED|95.0|1.78|19.23|||Cochran-Mantel-Haenszel|||Percentage difference between treatment groups from randomization strata of HbA1c (≤8.5, \>8.5%) at screening and randomization strata of sex (male, female) using Cochran-Mantel-Haenszel weights.||19.23|1.78|0.0172
72563100|NCT00442546|144658153|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.019|STANDARD_ERROR_OF_MEAN|0.094||0.8368||95.0|-0.206|0.167|||ANOVA||Mean difference (final values) = Least squares mean difference|96 hours||0.167|-0.206|0.8368
72563101|NCT00442546|144658153|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.019|STANDARD_ERROR_OF_MEAN|0.111||0.8659||95.0|-0.242|0.204|||ANOVA||Mean difference (final values) = Least squares mean difference|120 hours||0.204|-0.242|0.8659
72563102|NCT00442546|144658153|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.041|STANDARD_ERROR_OF_MEAN|0.112||0.7151||95.0|-0.266|0.184|||ANOVA||Mean difference (final values) = Least squares mean difference|120 hours||0.184|-0.266|0.7151
72563103|NCT00442546|144658153|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.097|STANDARD_ERROR_OF_MEAN|0.077||0.2121||95.0|-0.249|0.056|||ANOVA||Mean difference (final values) = Least squares mean difference|Discharge||0.056|-0.249|0.2121
72563104|NCT00442546|144658153|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.045|STANDARD_ERROR_OF_MEAN|0.077||0.5607||95.0|-0.197|0.107|||ANOVA||Mean difference (final values) = Least squares mean difference|Discharge||0.107|-0.197|0.5607
72500813|NCT04325503|144531964|OTHER|A comparison is not being made between two different treatment groups.|Mean Difference (Net)|0.333||||0.694|TWO_SIDED|95.0|-1.55|2.216||A priori threshold for statistical significance is p \< 0.05|t-test, 2 sided|Paired samples t-test, df = 8||||2.216|-1.550|0.694
72500814|NCT04325503|144531965|OTHER|A comparison is not being made between two different treatment groups.|Mean Difference (Net)|1.444||||0.103|TWO_SIDED|95.0|-0.363|3.252||A priori threshold for statistical significance was p \< 0.05|t-test, 2 sided|Paired samples t-test, df = 8||||3.252|-0.363|0.103
72500815|NCT04325503|144531966|OTHER|A comparison is not being made between two different treatment groups.|Mean Difference (Net)|-2.09||||0.321|TWO_SIDED|95.0|-6.554|2.372||A priori threshold for statistical significance p \< 0.05|t-test, 2 sided|Paired samples t-test, df = 10||||2.372|-6.554|0.321
72500816|NCT04325503|144531967|OTHER|A comparison is not being made between two different treatment groups.|Mean Difference (Net)|0.185||||0.265|TWO_SIDED|95.0|-0.175|0.544|||t-test, 2 sided|Paired samples t-test, df = 7||||0.544|-0.175|0.265
72500817|NCT04325503|144531968|OTHER|A comparison is not being made between two different treatment groups.|Mean Difference (Net)|8.143||||0.027|TWO_SIDED|95.0|1.296|15.0||A priori threshold for statistical significance p \< 0.05|t-test, 2 sided|Paired samples t-test, df = 6||||15.0|1.296|0.0270
72458991|NCT03386344|144440681|SUPERIORITY||Percentage Difference|12.0||||0.0076|TWO_SIDED|95.0|3.23|20.86|||Cochran-Mantel-Haenszel|||Percentage difference between treatment groups from randomization strata of HbA1c (≤8.5, \>8.5%) at screening and randomization strata of sex (male, female) using Cochran-Mantel-Haenszel weights.||20.86|3.23|0.0076
72458992|NCT01180400|144440686|SUPERIORITY_OR_OTHER||LS mean|-0.1|STANDARD_ERROR_OF_MEAN|0.91||0.944|TWO_SIDED|95.0|-1.86|1.73||The adjusted p-value protects the overall family-wise error rate by taking into account the multiple comparisons between the TC-5214 doses for both the primary efficacy variable (MADRS) and the key secondary efficacy variable (SDS).|MMRM|||Mixed model repeated measures (MMRM) includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization MADRS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||1.73|-1.86|0.944
72458993|NCT01180400|144440687|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.01|STANDARD_ERROR_OF_MEAN|0.26||0.974|TWO_SIDED|95.0|0.61|1.66|||Regression, Logistic||TC-5214 is the numerator in the OR, OR\>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization MADRS total score as a covariate.||1.66|0.61|0.974
72500818|NCT04325503|144531969|OTHER|A comparison is not being made between two different treatment groups.||||||0.153||||||A priori threshold for statistical significance p \< 0.05|Wilcoxon (Mann-Whitney)|||||||0.153
72500819|NCT01564784|144531979|SUPERIORITY_OR_OTHER||Rate difference|51.4|||<|0.0001|TWO_SIDED|97.5|38.4|64.3|||1-sided p-value based on Chi-square test|If any cell count was \<5, p-value was based on Fisher's exact test||||64.3|38.4|<0.0001
72500820|NCT01564784|144531980|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.751||||0.0105|TWO_SIDED|97.5|0.568|0.993|||1-sided stratified log-rank p-value||Stratified HR, i.e., based on analysis stratified by randomization stratification factors.|||0.993|0.568|0.0105
72500821|NCT01564784|144531981|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.49||||0.0021|TWO_SIDED|95.0|0.297|0.809|||1-sided stratified log-rank p-value||Stratified HR, i.e., based on analysis stratified by randomization stratification factors.|||0.809|0.297|0.0021
72500822|NCT01564784|144531982|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.45|||<|0.0001|TWO_SIDED|97.5|0.336|0.602|||1-sided stratified log-rank p-value||Stratified HR, i.e., based on analysis stratified by randomization stratification factors.|||0.602|0.336|<0.0001
72563105|NCT00442546|144658153|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.022|STANDARD_ERROR_OF_MEAN|0.077||0.7797||95.0|-0.13|0.173|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2||0.173|-0.130|0.7797
72458994|NCT01180400|144440688|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.45|STANDARD_ERROR_OF_MEAN|0.41||0.184|TWO_SIDED|95.0|0.84|2.53|||Regression, Logistic||TC-5214 is the numerator in the OR, OR\>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization MADRS total score as a covariate.||2.53|0.84|0.184
72500823|NCT01564784|144531983|SUPERIORITY_OR_OTHER||Rate difference|31.6|||<|0.0001|TWO_SIDED|95.0|22.6|40.6|||1-sided p-value based on Chi-square test|If any cell count was \<5, p-value was based on Fisher's exact test||||40.6|22.6|<0.0001
72500824|NCT01564784|144531984|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||1-sided p-value based on Chi-Square test|If any cell count is \<5, p-value was based on Fisher's exact test||||||<0.0001
72500825|NCT01564784|144531985|SUPERIORITY_OR_OTHER|||||||0.3168|||||||1-sided p-value based on Chi-Square test|If any cell count is \<5, p-value was based on Fisher's exact test||Abnormal at Screening||||0.3168
72500826|NCT01564784|144531985|SUPERIORITY_OR_OTHER|||||||0.216|||||||1-sided p-value based on Chi-Square test|If any cell count is \<5, p-value was based on Fisher's exact test||Abnormal after remission||||0.2160
72500827|NCT01564784|144531987|SUPERIORITY_OR_OTHER||Mean Difference (Net)|6.9||||0.0139|TWO_SIDED|95.0|1.4|12.3|||Mixed Models Analysis|Treatment, time, treatment-by-time interaction, and baseline included as covariate.||Physical Functioning||12.3|1.4|0.0139
72500828|NCT01564784|144531987|SUPERIORITY_OR_OTHER||Mean Difference (Net)|11.4||||0.0065|TWO_SIDED|95.0|3.2|19.5|||Mixed Models Analysis|Treatment, time, treatment-by-time interaction, and baseline included as covariate.||Role Functioning||19.5|3.2|0.0065
72500829|NCT01564784|144531987|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.3||||0.3307|TWO_SIDED|95.0|-6.9|2.3|||Mixed Models Analysis|Treatment, time, treatment-by-time interaction, and baseline included as covariate.||Emotional Functioning||2.3|-6.9|0.3307
72500830|NCT01564784|144531987|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.8||||0.1904|TWO_SIDED|95.0|-1.4|7.0|||Mixed Models Analysis|Treatment, time, treatment-by-time interaction, and baseline included as covariate.||Cognitive Functioning||7.0|-1.4|0.1904
72563106|NCT00442546|144658153|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.012|STANDARD_ERROR_OF_MEAN|0.079||0.8761||95.0|-0.143|0.167|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2||0.167|-0.143|0.8761
72563107|NCT00442546|144658153|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.012|STANDARD_ERROR_OF_MEAN|0.067||0.8619||95.0|-0.121|0.144|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4||0.144|-0.121|0.8619
72620923|NCT00452400|144772835|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.204|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001||95.0|0.162|0.247|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 10 mcg qd minus Placebo|||0.247|0.162|<0.0001
72458995|NCT01180400|144440689|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.44|STANDARD_ERROR_OF_MEAN|0.71||0.461|TWO_SIDED|95.0|0.55|3.78|||Regression, Logistic||TC-5214 is the numerator in the OR, OR\>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization MADRS total score as a covariate.||3.78|0.55|0.461
72458996|NCT01180400|144440690|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.87|STANDARD_ERROR_OF_MEAN|0.31||0.689|TWO_SIDED|95.0|0.43|1.75|||Regression, Logistic||TC-5214 is the numerator in the OR, OR\>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization MADRS total score as a covariate.||1.75|0.43|0.689
72458997|NCT01180400|144440691|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.9|STANDARD_ERROR_OF_MEAN|0.44||0.831|TWO_SIDED|95.0|0.35|2.32|||Regression, Logistic||TC-5214 is the numerator in the OR, OR\>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization MADRS total score as a covariate.||2.32|0.35|0.831
72458998|NCT01180400|144440692|SUPERIORITY_OR_OTHER||LS mean|0.5|STANDARD_ERROR_OF_MEAN|0.72||0.525|TWO_SIDED|95.0|-0.96|1.89|||ANCOVA|||Analysis of covariance (ANCOVA) with randomization HAMD-17 total score as covariate, treatment as a fixed effect and pooled center as a random effect.||1.89|-0.96|0.525
72458999|NCT01180400|144440693|SUPERIORITY_OR_OTHER||LS mean|0.0|STANDARD_ERROR_OF_MEAN|0.14||0.964||95.0|-0.28|0.26|||MMRM|||MMRM model includes treatment, pooled center, visit, and treatment by visit interaction as explanatory variables and the randomization CGI-S total score as a covariate. Treatment, visit, and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||0.26|-0.28|0.964
72459000|NCT01180400|144440694|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.93|STANDARD_ERROR_OF_MEAN|0.25||0.783|TWO_SIDED|95.0|0.54|1.58|||Regression, Logistic||TC-5214 is the numerator in the OR, OR\>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization Clinical Global Impression Severity (CGI-S) as a covariate.||1.58|0.54|0.783
72459001|NCT01180400|144440695|SUPERIORITY_OR_OTHER||LS mean|0.1|STANDARD_ERROR_OF_MEAN|0.51||0.832|TWO_SIDED|95.0|-0.89|1.11||Analysis for change in MADRS total score from randomization to Week 9.|MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization MADRS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||1.11|-0.89|0.832
72459002|NCT01180400|144440696|SUPERIORITY_OR_OTHER||LS mean|0.5|STANDARD_ERROR_OF_MEAN|0.67||0.468|TWO_SIDED|95.0|-0.84|1.82|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization MADRS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||1.82|-0.84|0.468
72459003|NCT01180400|144440697|SUPERIORITY_OR_OTHER||LS mean|1.0|STANDARD_ERROR_OF_MEAN|0.77||0.187|TWO_SIDED|95.0|-0.49|2.52|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization MADRS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||2.52|-0.49|0.187
72459004|NCT01180400|144440698|SUPERIORITY_OR_OTHER||LS mean|1.3|STANDARD_ERROR_OF_MEAN|0.86||0.145|TWO_SIDED|95.0|-0.44|2.95|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization MADRS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects the model; pooled center is a random effect.||2.95|-0.44|0.145
72459005|NCT01180400|144440699|SUPERIORITY_OR_OTHER||LS mean|-0.04|STANDARD_ERROR_OF_MEAN|0.766||0.956|TWO_SIDED|95.0|-1.549|1.466||The adjusted p-value protects the overall family-wise error rate by taking into account the multiple comparisons between the TC-5214 doses for both the primary efficacy variable (MADRS) and the key secondary efficacy variable (SDS).|MMRM|||MMRM model includes treatment, pooled center, visit, and treatment by visit interaction as explanatory variables and the randomization SDS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||1.466|-1.549|0.956
72459006|NCT01180400|144440700|SUPERIORITY_OR_OTHER||LS mean|-0.4|STANDARD_ERROR_OF_MEAN|0.3||0.201|TWO_SIDED|95.0|-0.98|0.21||Analysis for change in SDS work/school domain score from randomization (Week 8) to end of treatment (Week 16)|MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization SDS work/school domain score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||0.21|-0.98|0.201
72459007|NCT01180400|144440701|SUPERIORITY_OR_OTHER||LS mean|-0.1|STANDARD_ERROR_OF_MEAN|0.27||0.756|TWO_SIDED|95.0|-0.62|0.45|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization SDS social life domain score. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||0.45|-0.62|0.756
72500831|NCT01564784|144531987|SUPERIORITY_OR_OTHER||Mean Difference (Net)|8.4||||0.0336|TWO_SIDED|95.0|0.7|16.1|||Mixed Models Analysis|Treatment, time, treatment-by-time interaction, and baseline included as covariate.||Social Functioning||16.1|0.7|0.0336
72500832|NCT01564784|144531987|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.3||||0.1572|TWO_SIDED|95.0|-1.7|10.3|||Mixed Models Analysis|Treatment, time, treatment-by-time interaction, and baseline included as covariate.||Global Health Status||10.3|-1.7|0.1572
72500833|NCT01564784|144531987|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.7||||0.1281|TWO_SIDED|95.0|-10.8|1.4|||Mixed Models Analysis|Treatment, time, treatment-by-time interaction, and baseline included as covariate.||Dyspnoea||1.4|-10.8|0.1281
72500834|NCT01564784|144531987|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.7||||0.6207|TWO_SIDED|95.0|-8.7|5.2|||Mixed Models Analysis|Treatment, time, treatment-by-time interaction, and baseline included as covariate.||Insomnia||5.2|-8.7|0.6207
72500835|NCT01564784|144531987|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-8.7||||0.0193|TWO_SIDED|95.0|-16.0|-1.4|||Mixed Models Analysis|Treatment, time, treatment-by-time interaction, and baseline included as covariate.||Appetite Loss||-1.4|-16.0|0.0193
72459008|NCT01180400|144440702|SUPERIORITY_OR_OTHER||LS mean|0.1|STANDARD_ERROR_OF_MEAN|0.27||0.62|TWO_SIDED|95.0|-0.4|0.68|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization SDS family life/home responsibilities domain score. Treatment, visit and treatment by visit interaction are effects in the model; pooled center is a random effect.||0.68|-0.40|0.620
72459009|NCT01180400|144440703|SUPERIORITY_OR_OTHER||LS mean|0.15|STANDARD_ERROR_OF_MEAN|1.592||0.924|TWO_SIDED|95.0|-2.981|3.286|||ANCOVA|||ANCOVA with randomization Q-LES-Q-SF % maximum total score as covariate, treatment as a fixed effect and pooled center as a random effect.||3.286|-2.981|0.924
72620924|NCT00452400|144772835|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.203|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001||95.0|0.159|0.246|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 20 mcg qd minus Placebo|||0.246|0.159|<0.0001
72459010|NCT01180400|144440704|SUPERIORITY_OR_OTHER||LS mean|-0.1|STANDARD_ERROR_OF_MEAN|0.1||0.345|TWO_SIDED|95.0|-0.3|0.1|||ANCOVA|||An analysis of covariance (ANCOVA) with randomization Q-LES-Q-SF item 15 score as covariate, treatment as a fixed effect and pooled center as a random effect.||0.10|-0.30|0.345
72459011|NCT01180400|144440705|SUPERIORITY_OR_OTHER||LS mean|0.0|STANDARD_ERROR_OF_MEAN|0.1||0.942|TWO_SIDED|95.0|-0.2|0.19|||ANCOVA|||An analysis of covariance (ANCOVA) with randomization Q-LES-Q-SF item 16 as a fixed effect and pooled center as a random effect.||0.19|-0.20|0.942
72459012|NCT01180400|144440706|SUPERIORITY_OR_OTHER||LS mean|-0.011|STANDARD_ERROR_OF_MEAN|0.0198||0.576|TWO_SIDED|95.0|-0.05|0.0279||Analysis for change in EQ-5D index score from randomization (Week 8) to end of treatment (Week 16)|MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization EQ-5D total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||0.0279|-0.0500|0.576
72459013|NCT01180400|144440706|SUPERIORITY_OR_OTHER||LS mean|-0.4|STANDARD_ERROR_OF_MEAN|2.11||0.842|TWO_SIDED|95.0|-4.58|3.73||Analysis of change in EQ-5D VAS score from randomization (Week 8) to end of treatment (Week 16)|MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization EQ-5D VAS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||3.73|-4.58|0.842
72459014|NCT00248794|144440714|SUPERIORITY_OR_OTHER||||||<|0.97|||||||ANOVA|||||||<.97
72459015|NCT00248794|144440715|SUPERIORITY_OR_OTHER|||||||0.77|||||||ANOVA|||||||.77
72459016|NCT03449979|144440721|SUPERIORITY|||||||0.0852|||||||ANOVA|degrees of freedom = (1,39); F-statistic = 3.119||Interaction in the effect of tACS on left frontal alpha oscillation in the depressed group. Two-way interaction of within-participant factor of before/after tACS and between-participant factor of alpha-tACS/placebo.||||0.0852
72459017|NCT03449979|144440721|SUPERIORITY|||||||0.6676|||||||ANOVA|degrees of freedom = (1,39); F-statistic = 0.187||Interaction in the effect of tACS on left frontal alpha oscillation in the healthy group. Two-way interaction of within-participant factor of before/after tACS and between-participant factor of alpha-tACS/placebo.||||0.6676
72459018|NCT03449979|144440721|SUPERIORITY|||||||0.929||||||degrees of freedom = (1,41); F-statistic = 0.008|ANOVA|||Main effect of alpha-tACS on session (before and after) on left frontal alpha oscillations across both groups (healthy and patient).||||0.929
72500836|NCT01564784|144531987|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.4||||0.6249|TWO_SIDED|95.0|-4.4|7.3|||Mixed Models Analysis|Treatment, time, treatment-by-time interaction, and baseline included as covariate.||Constipation||7.3|-4.4|0.6249
72500837|NCT01564784|144531987|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.0||||0.1534|TWO_SIDED|95.0|-7.2|1.1|||Mixed Models Analysis|Treatment, time, treatment-by-time interaction, and baseline included as covariate.||Diarrhoea||1.1|-7.2|0.1534
72500838|NCT01564784|144531987|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.5||||0.4915|TWO_SIDED|95.0|-9.7|4.7|||Mixed Models Analysis|Treatment, time, treatment-by-time interaction, and baseline included as covariate.||Financial Difficulties||4.7|-9.7|0.4915
72500839|NCT01564784|144531987|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.4||||0.1789|TWO_SIDED|95.0|-10.8|2.0|||Mixed Models Analysis|Treatment, time, treatment-by-time interaction, and baseline included as covariate.||Fatigue||2.0|-10.8|0.1789
72500840|NCT01564784|144531987|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.6||||0.4578|TWO_SIDED|95.0|-6.0|2.7|||Mixed Models Analysis|Treatment, time, treatment-by-time interaction, and baseline included as covariate.||Nausea and Vomiting||2.7|-6.0|0.4578
72500841|NCT01564784|144531987|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.7||||0.8428|TWO_SIDED|95.0|-7.3|6.0|||Mixed Models Analysis|Treatment, time, treatment-by-time interaction, and baseline included as covariate.||Pain||6.0|-7.3|0.8428
72500842|NCT01564784|144531988|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.03||||0.171|TWO_SIDED|95.0|-0.01|0.07|||Mixed Models Analysis|Treatment, time, treatment-by-time interaction, and baseline included as covariate.||||0.07|-0.01|0.1710
72500843|NCT01564784|144531989|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.6||||0.1172|TWO_SIDED|95.0|-1.2|10.4|||Mixed Models Analysis|Treatment, time, treatment-by-time interaction, and baseline included as covariate.||||10.4|-1.2|0.1172
72459019|NCT03449979|144440721|SUPERIORITY|||||||0.195|||||||t-test, 1 sided|degrees of freedom = 20; t-statistic = -0.08789||Difference in alpha oscillations after versus before in the depressed cohort (one-tailed Student's t-test) with the hypothesis to decrease pathologically elevate left frontal alpha oscillations||||0.1950
72459020|NCT03449979|144440721|SUPERIORITY|||||||0.8603|||||||t-test, 1 sided|degrees of freedom = 20; t-statistic = 1.1117||Difference in alpha oscillations after versus before in the healthy cohort (one-tailed Student's t-test) run as a control analysis||||0.8603
72500844|NCT02370121|144531991|SUPERIORITY_OR_OTHER|||||||0.57|||||||Wilcoxon (Mann-Whitney)|||||||0.57
72500845|NCT02370121|144531992|SUPERIORITY_OR_OTHER|||||||0.07|||||||Wilcoxon (Mann-Whitney)|||||||0.07
72500846|NCT02370121|144531993|SUPERIORITY_OR_OTHER|||||||0.79|||||||Wilcoxon (Mann-Whitney)|||||||0.79
72500847|NCT02370121|144531994|SUPERIORITY_OR_OTHER|||||||0.08|||||||Wilcoxon (Mann-Whitney)|||||||0.08
72500848|NCT02370121|144531995|SUPERIORITY_OR_OTHER|||||||0.95|||||||Wilcoxon (Mann-Whitney)|||||||0.95
72500849|NCT02370121|144531996|SUPERIORITY_OR_OTHER|||||||0.92|||||||Wilcoxon (Mann-Whitney)|||||||0.92
72500850|NCT02370121|144531997|SUPERIORITY_OR_OTHER|||||||0.42|||||||Wilcoxon (Mann-Whitney)|||||||0.42
72500851|NCT02370121|144531998|SUPERIORITY_OR_OTHER|||||||0.77|||||||Wilcoxon (Mann-Whitney)|||||||0.77
72459021|NCT00700999|144440736|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.92|STANDARD_DEVIATION|0.9||0.001|TWO_SIDED|95.0|-1.38|-0.45|||t-test, 2 sided|||||-0.45|-1.38|.001
72459022|NCT00700999|144440736|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.07|STANDARD_DEVIATION|1.78||0.869|TWO_SIDED|95.0|-0.84|0.99|||t-test, 2 sided|||||.99|-.84|.869
72459023|NCT02991118|144440757|SUPERIORITY||Difference in LS mean|-17.42|STANDARD_ERROR_OF_MEAN|1.8|<|0.001|TWO_SIDED|95.0|-20.951|-13.896|||ANCOVA|||||-13.896|-20.951|<0.001
72459024|NCT02991118|144440758|SUPERIORITY||Difference in LS mean|-14.77|STANDARD_ERROR_OF_MEAN|2.418|<|0.001|TWO_SIDED|95.0|-19.504|-10.027|||ANCOVA|||||-10.027|-19.504|<0.001
72459025|NCT02991118|144440759|SUPERIORITY||Difference in LS mean|-13.03|STANDARD_ERROR_OF_MEAN|1.652|<|0.001|TWO_SIDED|95.0|-16.27|-9.794|||ANCOVA|||||-9.794|-16.270|<0.001
72459026|NCT02991118|144440760|SUPERIORITY||Difference in LS mean|-11.2|STANDARD_ERROR_OF_MEAN|1.224|<|0.001|TWO_SIDED|95.0|-13.599|-8.801|||ANCOVA|||||-8.801|-13.599|<0.001
72459027|NCT02991118|144440761|SUPERIORITY||Difference in LS mean|-13.02|STANDARD_ERROR_OF_MEAN|1.587|<|0.001|TWO_SIDED|95.0|-16.13|-9.907|||ANCOVA|||||-9.907|-16.130|<0.001
72459028|NCT02991118|144440762|SUPERIORITY||Location shift|-8.733|||<|0.039|TWO_SIDED|95.0|-17.238|-0.434|||Wilcoxon Rank Sum Test||The location shift and asymptotic 95% confidence interval are based on Hodges-Lehman estimation.|||-0.434|-17.238|<0.039
72500852|NCT02370121|144531999|SUPERIORITY_OR_OTHER|||||||0.17|||||||Wilcoxon (Mann-Whitney)|||||||0.17
72500853|NCT02370121|144532000|SUPERIORITY_OR_OTHER|||||||0.02|||||||Wilcoxon (Mann-Whitney)|||||||0.02
72500854|NCT02370121|144532001|SUPERIORITY_OR_OTHER|||||||0.02|||||||Wilcoxon (Mann-Whitney)|||||||0.02
72500855|NCT02370121|144532002|SUPERIORITY_OR_OTHER|||||||0.83|||||||Wilcoxon (Mann-Whitney)|||||||0.83
72620925|NCT00452400|144772836|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.187|STANDARD_ERROR_OF_MEAN|0.028|<|0.0001||95.0|0.131|0.243|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 2 mcg qd minus Placebo|||0.243|0.131|<0.0001
72459029|NCT02991118|144440765|SUPERIORITY||Difference in LS mean|4.89|STANDARD_ERROR_OF_MEAN|3.258||0.134|TWO_SIDED|95.0|-1.504|11.292|||ANCOVA|||||11.292|-1.504|0.134
72459030|NCT02991118|144440766|SUPERIORITY||Difference in LS mean|-6.13|STANDARD_ERROR_OF_MEAN|1.139|<|0.001|TWO_SIDED|95.0|-8.369|-3.896|||ANCOVA|||||-3.896|-8.369|<0.001
72459031|NCT02991118|144440767|SUPERIORITY||Difference in LS mean|-12.27|STANDARD_ERROR_OF_MEAN|2.314|<|0.001|TWO_SIDED|95.0|-16.813|-7.722|||ANCOVA|||||-7.722|-16.813|<0.001
72459032|NCT02991118|144440768|SUPERIORITY||Difference in LS mean|-12.63|STANDARD_ERROR_OF_MEAN|2.01|<|0.001|TWO_SIDED|95.0|-16.58|-8.682|||ANCOVA|||||-8.682|-16.580|<0.001
72459033|NCT02991118|144440769|SUPERIORITY||Difference in LS mean|-9.92|STANDARD_ERROR_OF_MEAN|1.976|<|0.001|TWO_SIDED|95.0|-13.803|-6.037|||ANCOVA|||||-6.037|-13.803|<0.001
72459034|NCT02991118|144440770|SUPERIORITY||Difference in LS mean|-10.77|STANDARD_ERROR_OF_MEAN|1.489|<|0.001|TWO_SIDED|95.0|-13.698|-7.848|||ANCOVA|||||-7.848|-13.698|<0.001
72459035|NCT02991118|144440771|SUPERIORITY||Difference in LS mean|-8.36|STANDARD_ERROR_OF_MEAN|1.458|<|0.001|TWO_SIDED|95.0|-11.223|-5.493|||ANCOVA|||||-5.493|-11.223|<0.001
72459036|NCT02991118|144440772|SUPERIORITY||Difference in LS mean|-13.0|STANDARD_ERROR_OF_MEAN|2.451|<|0.001|TWO_SIDED|95.0|-17.829|-8.175|||ANCOVA|||||-8.175|-17.829|<0.001
72459037|NCT02991118|144440773|SUPERIORITY||Difference in LS mean|-9.58|STANDARD_ERROR_OF_MEAN|1.796|<|0.001|TWO_SIDED|95.0|-13.107|-6.047|||ANCOVA|||||-6.047|-13.107|<0.001
72459038|NCT02991118|144440774|SUPERIORITY||Location shift|-21.278|||<|0.001|TWO_SIDED|95.0|-32.25|-10.034|||Wilcoxon Rank Sum Test||The location shift and asymptotic 95% confidence interval are based on Hodges-Lehman estimation.|||-10.034|-32.250|<0.001
72459039|NCT02991118|144440775|SUPERIORITY||Location shift|-7.587||||0.102|TWO_SIDED|95.0|-16.978|1.653|||Wilcoxon Rank Sum Test||The location shift and asymptotic 95% confidence interval are based on Hodges-Lehman estimation.|||1.653|-16.978|0.102
72459040|NCT02991118|144440776|SUPERIORITY||Difference in LS mean|-15.07|STANDARD_ERROR_OF_MEAN|2.641|<|0.001|TWO_SIDED|95.0|-20.26|-9.878|||ANCOVA|||||-9.878|-20.260|<0.001
72459041|NCT00595959|144440777|SUPERIORITY_OR_OTHER|||||||0.001||||||No adjustments|t-test, 1 sided|||Comparing to an expected value of 20% reduction from initial to post-laser||||0.001
72459042|NCT03032965|144440798|SUPERIORITY|||||||0.83|||||||Log Rank|Kaplan Meier log rank||||||.83
72459043|NCT03032965|144440799|SUPERIORITY|||||||0.35|||||||t-test, 2 sided|||||||.35
72459044|NCT03032965|144440801|SUPERIORITY|||||||0.09|||||||t-test, 2 sided|||||||0.09
72459045|NCT00636168|144440807|SUPERIORITY||Hazard Ratio (HR)|0.75||||0.0013|TWO_SIDED|95.0|0.64|0.9|||Log Rank|stratified 2-sided log-rank test||The hazard ratio, and its 95 % confidence interval was estimated using a Cox proportional hazards model, stratified by stage (IIIa vs. IIIb vs. IIIc with 1-3 positive lymph-nodes vs. IIIc with \>= 4 positive lymph-nodes) as indicated at randomization, with treatment as the single covariate.. The analysis was performed after 528 RFS events per IRC were reported. Two-sided, 95% confidence intervals for median RFS were computed by the Brookmeyer and Crowley method using log-log transformation.||0.90|0.64|0.0013
72459046|NCT00636168|144440810|SUPERIORITY||Hazard Ratio (HR)|0.76||||0.0024|TWO_SIDED|95.8|0.64|0.92|||Log Rank|stratified 2-sided log-rank test||Medians and associated 2-sided 95% confidence intervals are calculated using the method of Brookmeyer and Crowley. Analysis was stratified for stage (IIIa vs. IIIb vs. IIIc with 1-3 positive lymph-nodes vs. IIIc with \>= 4 positive lymph-nodes) as recorded at randomization. P-value was based on stratified 2-sided log-rank test. Hazard of 10 mg/kg Ipilimumab over hazard of Placebo, with 2-sided 95.8% confidence interval are based on a stratified Cox proportional hazards model||0.92|0.64|0.0024
72500856|NCT02370121|144532003|SUPERIORITY_OR_OTHER|||||||0.24|||||||Wilcoxon (Mann-Whitney)|||||||0.24
72500857|NCT02370121|144532004|SUPERIORITY_OR_OTHER|||||||0.05|||||||Wilcoxon (Mann-Whitney)|||||||0.05
72500858|NCT02370121|144532005|SUPERIORITY_OR_OTHER|||||||0.32|||||||Wilcoxon (Mann-Whitney)|||||||0.32
72500859|NCT02370121|144532006|SUPERIORITY_OR_OTHER|||||||0.17|||||||Wilcoxon (Mann-Whitney)|||||||0.17
72500860|NCT02370121|144532007|SUPERIORITY_OR_OTHER|||||||0.89|||||||Wilcoxon (Mann-Whitney)|||||||0.89
72500861|NCT00963807|144532028|SUPERIORITY_OR_OTHER|||||||0.336|||||||t-test, 2 sided|||||||0.336
72500862|NCT05198713|144532032|OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
72500863|NCT02511522|144532071|SUPERIORITY|||||||0.004|||||||Cochran-Mantel-Haenszel|Adjusting for stratification factor (Hepatocellular carcinoma versus liver metastases)||||||0.004
72459047|NCT00636168|144440813|SUPERIORITY||Hazard Ratio (HR)|0.72||||0.0013|TWO_SIDED|95.1|0.58|0.88|||Log Rank|stratified 2-sided log-rank test||Medians and associated 2-sided 95% confidence intervals are calculated using the method of Brookmeyer and Crowley. Analysis was stratified for stage (IIIa vs. IIIb vs. IIIc with 1-3 positive lymph-nodes vs. IIIc with \>= 4 positive lymph-nodes) as recorded at randomization. P-value was based on stratified 2-sided log-rank test. Hazard of 10 mg/kg Ipilimumab over hazard of Placebo, with 2-sided 95.1% confidence interval are based on a stratified Cox proportional hazards model||0.88|0.58|0.0013
72459048|NCT02707952|144440822|NON_INFERIORITY|The percentage of participants achieving SVR12 was calculated for each arm and a 2-sided 95% CI for the difference in SVR12 rates (Arm A minus Arm B) was calculated using the normal approximation to the binomial distribution to assess non-inferiority in SVR12 rates of arm A to arm B. If the lower bound of the confidence interval (CI) for the difference was above the non-inferiority margin of -10%, then arm A was considered non-inferior to arm B.|Rate Difference|-0.9|||||TWO_SIDED|95.0|-2.8|0.9|||||95% CI was calculated using the normal approximation to the binomial distribution.|||0.9|-2.8|
72459049|NCT02006641|144440827|SUPERIORITY||Mean Difference (Final Values)|-0.09|STANDARD_ERROR_OF_MEAN|0.51||1|TWO_SIDED|95.0|-1.1|0.92||Corrected for multiplicity|Mixed Models Analysis|Treatment, country, MMSE stratum, week as fixed effects, baseline score, treatment-by-week, MMSE stratum-by-week, and baseline-by-week interactions|A negative mean difference indicates a treatment effect in favour of idalopirdine|For demonstrating efficacy of a dose, change in cognition (ADAS-cog) and either change in daily functioning (ADCS-ADL23) or change in global clinical impression (ADCS-CGIC) at Week 24 had to show statistically significant favourable differences compared to placebo at Week 24. Overall, type 1 error was controlled at 5% by multiplicity adjustment. Testing of the doses was done in a gated manner, first testing 30 mg at a 5% significance level, and only if found efficacious, then moving on to 10 mg.||0.92|-1.10|1.000
72459050|NCT02006641|144440827|SUPERIORITY||Mean Difference (Final Values)|0.63|STANDARD_ERROR_OF_MEAN|0.52||0.2223|TWO_SIDED|95.0|-0.38|1.65||Corrected for multiplicity according to the multiple testing procedure|Mixed Models Analysis|Treatment, country, MMSE stratum, week as fixed effects, baseline score, treatment-by-week, MMSE stratum-by-week, and baseline-by-week interactions|A negative mean difference indicates a treatment effect in favour of idalopirdine.|For demonstrating efficacy of a dose, change in cognition (ADAS-cog) and either change in daily functioning (ADCS-ADL23) or change in global clinical impression (ADCS-CGIC) at Week 24 had to show statistically significant favourable differences compared to placebo at Week 24. Overall, type 1 error was controlled at 5% by multiplicity adjustment. Testing of the doses was done in a gated manner, first testing 30 mg at a 5% significance level, and only if found efficacious, then moving on to 10 mg.||1.65|-0.38|0.2223
72459051|NCT02006641|144440828|SUPERIORITY||Mean Difference (Net)|0.17|STANDARD_ERROR_OF_MEAN|0.65||1|TWO_SIDED|95.0|-1.11|1.46||Corrected for multiplicity according to the multiple testing procedure|Mixed Models Analysis|Treatment, country, MMSE stratum, week as fixed effects, baseline score, treatment-by-week, MMSE stratum-by-week, and baseline-by-week interactions|A positive mean difference indicates a treatment effect in favour of idalopirdine.|For demonstrating efficacy of a dose, change in cognition (ADAS-cog) and either change in daily functioning (ADCS-ADL23) or change in global clinical impression (ADCS-CGIC) at Week 24 had to show statistically significant favourable differences compared to placebo at Week 24. Overall, type 1 error was controlled at 5% by multiplicity adjustment. Testing of the doses was done in a gated manner, first testing 30 mg at a 5% significance level, and only if found efficacious, then moving on to 10 mg.||1.46|-1.11|1.000
72459052|NCT02006641|144440828|SUPERIORITY||Mean Difference (Final Values)|0.03|STANDARD_ERROR_OF_MEAN|0.66||1|TWO_SIDED|95.0|-1.27|1.33||Corrected for multiplicity according to the multiple testing procedure|Mixed Models Analysis|Treatment, country, MMSE stratum, week as fixed effects, baseline score, treatment-by-week, MMSE stratum-by-week, and baseline-by-week interactions|A positive mean difference indicates a treatment effect in favour of idalopirdine.|For demonstrating efficacy of a dose, change in cognition (ADAS-cog) and either change in daily functioning (ADCS-ADL23) or change in global clinical impression (ADCS-CGIC) at Week 24 had to show statistically significant favourable differences compared to placebo at Week 24. Overall, type 1 error was controlled at 5% by multiplicity adjustment. Testing of the doses was done in a gated manner, first testing 30 mg at a 5% significance level, and only if found efficacious, then moving on to 10 mg.||1.33|-1.27|1.000
72459053|NCT02006641|144440829|SUPERIORITY||Mean Difference (Final Values)|-0.07|STANDARD_ERROR_OF_MEAN|0.08||1|TWO_SIDED|95.0|-0.23|0.1||Corrected for multiplicity according to the multiple testing procedure|Mixed Models Analysis|Treatment, country, MMSE stratum, week as fixed effects, baseline score, treatment-by-week, MMSE stratum-by-week, and baseline-by-week interactions|A negative mean difference indicates a treatment effect in favour of idalopirdine.|For demonstrating efficacy of a dose, change in cognition (ADAS-cog) and either change in daily functioning (ADCS-ADL23) or change in global clinical impression (ADCS-CGIC) at Week 24 had to show statistically significant favourable differences compared to placebo at Week 24. Overall, type 1 error was controlled at 5% by multiplicity adjustment. Testing of the doses was done in a gated manner, first testing 30 mg at a 5% significance level, and only if found efficacious, then moving on to 10 mg.||0.10|-0.23|1.000
72470071|NCT01124838|144464405|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference|2.36||||0.256|TWO_SIDED|95.0|-1.73|6.45|||ANOVA|From ANOVA of change from baseline to final/early termination visit with treatment and race (Japanese versus non-Japanese) as factors.||The statistical test for the ranked secondary variables was carried out in hierarchical order at the significance level of 5%.||6.45|-1.73|0.256
72470072|NCT01124838|144464406|SUPERIORITY_OR_OTHER_LEGACY||Mena Difference|-0.1||||0.967|TWO_SIDED|95.0|-4.81|4.61|||ANOVA|From ANOVA of change from baseline to final/early termination visit with treatment as a factor.||The statistical test for the ranked secondary variables was carried out in hierarchical order at the significance level of 5%.||4.61|-4.81|0.967
72470073|NCT01124838|144464406|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference|-0.87||||0.714|TWO_SIDED|95.0|-5.53|3.79|||ANOVA|From ANOVA of change from baseline to final/early termination visit with treatment and race (Japanese versus non-Japanese) as factors.||The statistical test for the ranked secondary variables was carried out in hierarchical order at the significance level of 5%.||3.79|-5.53|0.714
72470074|NCT01124838|144464407|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference|0.56||||0.83|TWO_SIDED|95.0|-4.56|5.68|||ANOVA|From ANOVA of change from baseline to final/early termination visit with treatment as a factor.||The statistical test for the ranked secondary variables was carried out in hierarchical order at the significance level of 5%.||5.68|-4.56|0.830
72459054|NCT02006641|144440829|SUPERIORITY||Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.09||1|TWO_SIDED|95.0|-0.12|0.21||Corrected for multiplicity according to the multiple testing procedure|Mixed Models Analysis|Treatment, country, MMSE stratum, week as fixed effects, baseline score, treatment-by-week, MMSE stratum-by-week, and baseline-by-week interactions|A negative mean difference indicates a treatment effect in favour of idalopirdine.|For demonstrating efficacy of a dose, change in cognition (ADAS-cog) and either change in daily functioning (ADCS-ADL23) or change in global clinical impression (ADCS-CGIC) at Week 24 had to show statistically significant favourable differences compared to placebo at Week 24. Overall, type 1 error was controlled at 5% by multiplicity adjustment. Testing of the doses was done in a gated manner, first testing 30 mg at a 5% significance level, and only if found efficacious, then moving on to 10 mg.||0.21|-0.12|1.000
72459055|NCT01047709|144440849|SUPERIORITY_OR_OTHER||relative % difference|19.5|STANDARD_DEVIATION|23.0||0.011|TWO_SIDED|95.0|4.9|31.9|||GEE||SD of control night|Relative treatment effect on AHI, using GEE modeling, accounting for crossover design.||31.9|4.9|0.011
72459056|NCT01047709|144440849|SUPERIORITY_OR_OTHER||Relative % difference|19.5|STANDARD_DEVIATION|16.0||0.011||95.0|4.9|31.9|||GEE||SD of intervention night|Relative treatment effect on AHI, using GEE modeling, accounting for crossover design.||31.9|4.9|0.011
72563108|NCT00442546|144658153|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.024|STANDARD_ERROR_OF_MEAN|0.068||0.7256||95.0|-0.111|0.159|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4||0.159|-0.111|0.7256
72563109|NCT00442546|144658153|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.061||0.8659||95.0|-0.11|0.131|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET||0.131|-0.110|0.8659
72459057|NCT01697956|144440855|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was demonstrated if the lower limit of the two-sided 95% CI for the geometric mean ratio of BDP nasal aerosol versus placebo was greater than 0.80.|ratio of BDP nasal aerosol to placebo|0.91|||||TWO_SIDED|95.0|0.81|1.03||||||The standard deviation of the logarithmically transformed data on the change from baseline (expressed as a ratio) in 24-hr serum cortisol weighted mean is assumed to be 0.30. Using this standard deviation, 90 subjects (approximately 60 and 30 subjects in the BDP Nasal Aerosol and placebo groups, respectively) will yield approximately 90% power to demonstrate non-inferiority between BDP Nasal Aerosol and placebo, if there is no true difference between treatment groups.||1.03|0.81|
72459058|NCT01115309|144440866|SUPERIORITY||||||<|0.0001||||||Paired t-tests were used to evaluate whether the change in outcomes from baseline to follow-up were statistically different from zero. A p value \<0.05 is considered statistically significant.|t-test, 2 sided|||||||<0.0001
72459059|NCT01115309|144440867|SUPERIORITY||||||<|0.0001||||||Paired t-tests were used to evaluate whether the change in outcomes from baseline to follow-up were statistically different from zero. A p value \<0.05 is considered statistically significant.|t-test, 2 sided|||||||<0.0001
72459060|NCT01307800|144440925|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|4.1|STANDARD_ERROR_OF_MEAN|2.4||0.994|TWO_SIDED|95.0|-0.5|8.8||The comparison between 80 mg LY2140023, BID and placebo was conducted at a 1-sided alpha level of 0.025, with adjustment for multiplicity by applying the Step-down Dunnett procedure.|Mixed Models Analysis|||||8.8|-0.5|0.994
72459061|NCT01307800|144440925|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|3.0|STANDARD_ERROR_OF_MEAN|2.5||0.973|TWO_SIDED|95.0|-1.9|7.9||The comparison between 40 mg LY2140023, BID and placebo was conducted at a 1-sided alpha level of 0.025, with adjustment for multiplicity by applying the Step-down Dunnett procedure.|Mixed Models Analysis|||||7.9|-1.9|0.973
72459062|NCT01307800|144440925|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|2.8|STANDARD_ERROR_OF_MEAN|2.2||0.896|TWO_SIDED|95.0|-1.6|7.2||The p-value was 1-sided without adjustment for multiplicity.|Mixed Models Analysis|||||7.2|-1.6|0.896
72459063|NCT01307800|144440926|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|4.3|STANDARD_ERROR_OF_MEAN|2.5||0.955|TWO_SIDED|95.0|-0.7|9.3||The p-value was 1-sided without adjustment for multiplicity.|Mixed Models Analysis|||||9.3|-0.7|0.955
72459064|NCT01307800|144440926|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|3.4|STANDARD_ERROR_OF_MEAN|2.5||0.912|TWO_SIDED|95.0|-1.6|8.4||The p-value was 1-sided without adjustment for multiplicity.|Mixed Models Analysis|||||8.4|-1.6|0.912
72459065|NCT01307800|144440926|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|2.9|STANDARD_ERROR_OF_MEAN|2.4||0.223|TWO_SIDED|95.0|-1.8|7.7||The p-value was 1-sided without adjustment for multiplicity.|Mixed Models Analysis|||||7.7|-1.8|0.223
72459066|NCT01307800|144440927|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.4|STANDARD_ERROR_OF_MEAN|1.5||0.61|TWO_SIDED|95.0|-3.5|2.6||The p-value was 1-sided without adjustment for multiplicity.|Mixed Models Analysis|||||2.6|-3.5|0.610
72459067|NCT01307800|144440927|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.3|STANDARD_ERROR_OF_MEAN|1.7||0.223|TWO_SIDED|95.0|-2.0|4.6||The p-value was 1-sided without adjustment for multiplicity.|Mixed Models Analysis|||||4.6|-2.0|0.223
72459068|NCT01307800|144440927|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.2|STANDARD_ERROR_OF_MEAN|1.5||0.414|TWO_SIDED|95.0|-4.2|1.7||The p-value was 2-sided without adjustment for multiplicity.|Mixed Models Analysis|||||1.7|-4.2|0.414
72459069|NCT01307800|144440928|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.4|STANDARD_ERROR_OF_MEAN|1.6||0.603|TWO_SIDED|95.0|-3.7|2.8||The p-value was 1-sided without adjustment for multiplicity.|Mixed Models Analysis|||||2.8|-3.7|0.603
72459070|NCT01307800|144440928|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.5|STANDARD_ERROR_OF_MEAN|1.7||0.192|TWO_SIDED|95.0|-1.9|4.8||The p-value was 1-sided without adjustment for multiplicity.|Mixed Models Analysis|||||4.8|-1.9|0.192
72563110|NCT00442546|144658153|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.146|STANDARD_ERROR_OF_MEAN|0.063||0.0203||95.0|0.023|0.27|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET||0.270|0.023|0.0203
72563111|NCT00442546|144658154|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.041|STANDARD_ERROR_OF_MEAN|0.074||0.5791||95.0|-0.187|0.105|||ANOVA||Mean difference (final values) = Least squares mean difference|24 hours||0.105|-0.187|0.5791
72563112|NCT00442546|144658154|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.031|STANDARD_ERROR_OF_MEAN|0.075||0.6829||95.0|-0.178|0.117|||ANOVA||Mean difference (final values) = Least squares mean difference|24 hours||0.117|-0.178|0.6829
72459071|NCT01307800|144440928|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.8|STANDARD_ERROR_OF_MEAN|1.6||0.619|TWO_SIDED|95.0|-3.9|2.3||The p-value was 2-sided without adjustment for multiplicity.|Mixed Models Analysis|||||2.3|-3.9|0.619
72459072|NCT01307800|144440929|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|9.5|STANDARD_ERROR_OF_MEAN|4.1||0.022|TWO_SIDED|95.0|1.4|17.6||The p-value was 2-sided without adjustment for multiplicity.|Mixed Models Analysis|||||17.6|1.4|0.022
72459073|NCT01307800|144440929|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|8.7|STANDARD_ERROR_OF_MEAN|4.6||0.061|TWO_SIDED|95.0|-0.4|17.8||The p-value was 2-sided without adjustment for multiplicity.|Mixed Models Analysis|||||17.8|-0.4|0.061
72459074|NCT01307800|144440929|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|4.2|STANDARD_ERROR_OF_MEAN|4.1||0.304|TWO_SIDED|95.0|-3.9|12.3||The p-value was 2-sided without adjustment for multiplicity.|Mixed Models Analysis|||||12.3|-3.9|0.304
72459075|NCT01307800|144440930|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.6|STANDARD_ERROR_OF_MEAN|0.8||0.036|TWO_SIDED|95.0|0.1|3.1||The comparison between 80 mg LY2140023, BID and placebo for the change from baseline in PANSS positive subscores was 2-sided without adjustment for multiplicity.|Mixed Models Analysis|||||3.1|0.1|0.036
72459076|NCT01307800|144440930|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.4|STANDARD_ERROR_OF_MEAN|0.8||0.616|TWO_SIDED|95.0|-1.2|2.0||The comparison between 40 mg LY2140023, BID and placebo for change from baseline in PANSS positive subscores was 2-sided without adjustment for multiplicity.|Mixed Models Analysis|||||2.0|-1.2|0.616
72459077|NCT01307800|144440930|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.7|STANDARD_ERROR_OF_MEAN|0.7||0.307|TWO_SIDED|95.0|-0.7|2.2||The comparison between 10 mg LY2140023, BID and placebo for change from baseline in PANSS positive subscores was 2-sided without adjustment for multiplicity.|Mixed Models Analysis|||||2.2|-0.7|0.307
72459078|NCT01307800|144440930|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.7|STANDARD_ERROR_OF_MEAN|0.7||0.382|TWO_SIDED|95.0|-0.8|2.1||The comparison between 80 mg LY2140023, BID and placebo for the change from baseline in PANSS negative subscores was 2-sided without adjustment for multiplicity.|Mixed Models Analysis|||||2.1|-0.8|0.382
72459079|NCT01307800|144440930|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.3|STANDARD_ERROR_OF_MEAN|0.8||0.107|TWO_SIDED|95.0|-0.3|2.8||The comparison between 40 mg LY2140023, BID and placebo for the change from baseline in PANSS negative subscores was 2-sided without adjustment for multiplicity.|Mixed Models Analysis|||||2.8|-0.3|0.107
72459080|NCT01307800|144440930|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.6|STANDARD_ERROR_OF_MEAN|0.7||0.436|TWO_SIDED|95.0|-0.9|2.0||The comparison between 10 mg LY2140023, BID and placebo for the change from baseline in PANSS negative subscores was 2-sided without adjustment for multiplicity.|Mixed Models Analysis|||||2.0|-0.9|0.436
72459081|NCT01307800|144440930|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|2.3|STANDARD_ERROR_OF_MEAN|1.3||0.073|TWO_SIDED|95.0|-0.2|4.9||The comparison between 80 mg LY2140023, BID and placebo for the change from baseline in PANSS general psychopathology subscores was 2-sided without adjustment for multiplicity.|Mixed Models Analysis|||||4.9|-0.2|0.073
72500864|NCT02511522|144532072|SUPERIORITY|||||||0.068|||||||Log Rank|Stratified Log Rank test adjusting for the stratification factor (Hepatocellular carcinoma versus liver metastases)||||||0.068
72500865|NCT02511522|144532073|SUPERIORITY|||||||0.45|||||||Cochran-Mantel-Haenszel|adjusting for the stratification factor (Hepatocellular carcinoma versus liver metastases)||||||0.45
72500866|NCT02511522|144532074|SUPERIORITY|||||||0.07|||||||Cochran-Mantel-Haenszel|adjusting for the stratification factor (Hepatocellular carcinoma versus liver metastases)||||||0.07
72500867|NCT02660580|144532075|EQUIVALENCE|MSB11022 was considered equivalent to EU-Humira if the 95% CI for the treatment difference was included in the equivalence interval \[-15%, 15%\]).|Least Square (LS) Mean difference|0.88|||||TWO_SIDED|95.0|-1.21|2.98||||||||2.98|-1.21|
72500868|NCT02660580|144532091|EQUIVALENCE|MSB11022 was considered equivalent to EU-Humira if the 95% stratified Newcombe Confidence Interval (CI) for the difference in percentage was included in the equivalence interval (-18, 18).|Percentage difference|-1.9|||||TWO_SIDED|95.0|-7.82|4.07||||||||4.07|-7.82|
72500869|NCT01381094|144532135|SUPERIORITY||Mean Difference (Net)|0.8|||||TWO_SIDED|95.0|0.24|1.35||||||||1.35|0.24|
72459082|NCT01307800|144440930|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.5|STANDARD_ERROR_OF_MEAN|1.4||0.28|TWO_SIDED|95.0|-1.2|4.2||The comparison between 40 mg LY2140023, BID and placebo for the change from baseline in PANSS general psychopathology subscores was 2-sided without adjustment for multiplicity.|Mixed Models Analysis|||||4.2|-1.2|0.280
72459083|NCT01307800|144440930|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.6|STANDARD_ERROR_OF_MEAN|1.3||0.209|TWO_SIDED|95.0|-0.9|4.0||The comparison between 10 mg LY2140023, BID and placebo for the change from baseline in PANSS general psychopathology subscores was 2-sided without adjustment for multiplicity.|Mixed Models Analysis|||||4.0|-0.9|0.209
72459084|NCT01307800|144440931|SUPERIORITY_OR_OTHER_LEGACY|||||||0.137||95.0||||The p-value was 2-sided without adjustment for multiplicity.|Fisher Exact|||||||0.137
72459085|NCT01307800|144440931|SUPERIORITY_OR_OTHER_LEGACY|||||||0.824||95.0||||The p-value was 2-sided without adjustment for multiplicity.|Fisher Exact|||||||0.824
72459086|NCT01307800|144440931|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.999||95.0||||The p-value was 2-sided without adjustment for multiplicity.|Fisher Exact|||||||>0.999
72459087|NCT01307800|144440933|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.12|STANDARD_ERROR_OF_MEAN|0.13||0.34|TWO_SIDED|95.0|-0.13|0.38||The p-value was 2-sided without adjustment for multiplicity.|Mixed Models Analysis|||||0.38|-0.13|0.340
72459088|NCT01307800|144440933|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.06|STANDARD_ERROR_OF_MEAN|0.14||0.659|TWO_SIDED|95.0|-0.33|0.21||The p-value was 2-sided without adjustment for multiplicity.|Mixed Models Analysis|||||0.21|-0.33|0.659
72500870|NCT01381094|144532135|SUPERIORITY||Mean Difference (Net)|0.76|||||TWO_SIDED|95.0|0.2|1.33||||||||1.33|0.20|
72500871|NCT01381094|144532135|SUPERIORITY||Mean Difference (Net)|1.28|||||TWO_SIDED|95.0|0.73|1.83||||||||1.83|0.73|
72500872|NCT01381094|144532135|SUPERIORITY||Mean Difference (Net)|1.45|||||TWO_SIDED|95.0|0.91|2.0||||||||2.00|0.91|
72500873|NCT01381094|144532135|SUPERIORITY||||||<|0.0001|TWO_SIDED||||||ANOVA|||||||<0.0001
72500874|NCT01381094|144532136|SUPERIORITY||||||=|0.9355|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 1).||||=0.9355
72459089|NCT01307800|144440933|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.1|STANDARD_ERROR_OF_MEAN|0.12||0.413|TWO_SIDED|95.0|-0.14|0.35||The p-value was 2-sided without adjustment for multiplicity.|Mixed Models Analysis|||||0.35|-0.14|0.413
72459090|NCT01307800|144440934|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.2|STANDARD_ERROR_OF_MEAN|1.5||0.91|TWO_SIDED|95.0|-3.1|2.7||The p-value was 2-sided without adjustment for multiplicity.|Mixed Models Analysis|||||2.7|-3.1|0.910
72459091|NCT01307800|144440934|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.8|STANDARD_ERROR_OF_MEAN|1.6||0.265|TWO_SIDED|95.0|-4.9|1.3||The p-value was 2-sided without adjustment for multiplicity.|Mixed Models Analysis|||||1.3|-4.9|0.265
72459092|NCT01307800|144440934|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.9|STANDARD_ERROR_OF_MEAN|1.4||0.531|TWO_SIDED|95.0|-3.7|1.9||The p-value was 2-sided without adjustment for multiplicity.|Mixed Models Analysis|||||1.9|-3.7|0.531
72459093|NCT01307800|144440935|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.06|STANDARD_ERROR_OF_MEAN|2.62||0.983|TWO_SIDED|95.0|-5.21|5.1||The comparison between 80 mg LY2140023, BID and placebo for the change from baseline in EQ-5D Questionnaire (VAS) was 2-sided without adjustment for multiplicity.|ANCOVA|||||5.10|-5.21|0.983
72459094|NCT01307800|144440935|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-2.56|STANDARD_ERROR_OF_MEAN|2.74||0.351|TWO_SIDED|95.0|-7.94|2.83||The comparison between 40 mg LY2140023, BID and placebo for the change from baseline in EQ-5D Questionnaire (VAS) was 2-sided without adjustment for multiplicity.|ANCOVA|||||2.83|-7.94|0.351
72459095|NCT01307800|144440935|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|2.12|STANDARD_ERROR_OF_MEAN|2.54||0.403|TWO_SIDED|95.0|-2.86|7.11||The comparison between 10 mg LY2140023, BID and placebo for the change from baseline in EQ-5D Questionnaire (VAS) was 2-sided without adjustment for multiplicity.|ANCOVA|||||7.11|-2.86|0.403
72459096|NCT01307800|144440938|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-5.6|STANDARD_ERROR_OF_MEAN|2.4||0.021|TWO_SIDED|95.0|-10.4|-0.8||The p-value was 2-sided without adjustment for multiplicity.|Mixed Models Analysis|||||-0.8|-10.4|0.021
72500875|NCT01381094|144532136|SUPERIORITY||||||=|0.6594|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 1).||||=0.6594
72500876|NCT01381094|144532136|SUPERIORITY||||||=|0.0203|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 1).||||=0.0203
72500877|NCT01381094|144532136|SUPERIORITY||||||=|0.0369|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 1).||||=0.0369
72500878|NCT01381094|144532136|SUPERIORITY|p-value was based on the comparison within treatment group (Change from Baseline to Week 1).|||||=|0.3713|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||||||=0.3713
72459097|NCT01307800|144440938|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.8|STANDARD_ERROR_OF_MEAN|2.6||0.487|TWO_SIDED|95.0|-3.3|6.9||The p-value was 2-sided without adjustment for multiplicity.|Mixed Models Analysis|||||6.9|-3.3|0.487
72459098|NCT01307800|144440938|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.9|STANDARD_ERROR_OF_MEAN|2.4||0.693|TWO_SIDED|95.0|-5.6|3.7||The p-value was 2-sided without adjustment for multiplicity.|Mixed Models Analysis|||||3.7|-5.6|0.693
72459099|NCT01307800|144440939|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.02|STANDARD_ERROR_OF_MEAN|0.04||0.661|TWO_SIDED|95.0|-0.1|0.06||The comparison between 80 mg LY2140023, BID and placebo was conducted at a 2-sided alpha level of 0.05 without adjustment for multiplicity.|Mixed Models Analysis|||||0.06|-0.10|0.661
72459100|NCT01307800|144440939|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.06|STANDARD_ERROR_OF_MEAN|0.04||0.201|TWO_SIDED|95.0|-0.14|0.03||The comparison between 40 mg LY2140023, BID and placebo was conducted at a 2-sided alpha level of 0.05 without adjustment for multiplicity.|Mixed Models Analysis|||||0.03|-0.14|0.201
72459101|NCT01307800|144440939|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.02|STANDARD_ERROR_OF_MEAN|0.04||0.697|TWO_SIDED|95.0|-0.09|0.06||The comparison between 10 mg LY2140023, BID and placebo was conducted at a 2-sided alpha level of 0.05 without adjustment for multiplicity.|Mixed Models Analysis|||||0.06|-0.09|0.697
72459102|NCT01307800|144440940|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.05|STANDARD_ERROR_OF_MEAN|0.13||0.694|TWO_SIDED|95.0|-0.2|0.31||The comparison between 80 mg LY2140023, BID and placebo was conducted at a 2-sided alpha level of 0.05 without adjustment for multiplicity.|Mixed Models Analysis|||||0.31|-0.20|0.694
72459103|NCT01307800|144440940|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.07|STANDARD_ERROR_OF_MEAN|0.14||0.596|TWO_SIDED|95.0|-0.34|0.2||The comparison between 40 mg LY2140023, BID and placebo was conducted at a 2-sided alpha level of 0.05 without adjustment for multiplicity.|Mixed Models Analysis|||||0.20|-0.34|0.596
72459104|NCT01307800|144440940|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.24|STANDARD_ERROR_OF_MEAN|0.13||0.055|TWO_SIDED|95.0|0.0|0.49||The comparison between 10 mg LY2140023, BID and placebo was conducted at a 2-sided alpha level of 0.05 without adjustment for multiplicity.|Mixed Models Analysis|||||0.49|0.00|0.055
72459105|NCT01307800|144440941|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.01|STANDARD_ERROR_OF_MEAN|0.14||0.929|TWO_SIDED|95.0|-0.27|0.29||The comparison between 80 mg LY2140023, BID and placebo was conducted at a 2-sided alpha level of 0.05 without adjustment for multiplicity.|Mixed Models Analysis|||||0.29|-0.27|0.929
72459106|NCT01307800|144440941|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.09|STANDARD_ERROR_OF_MEAN|0.15||0.519|TWO_SIDED|95.0|-0.19|0.38||The comparison between 40 mg LY2140023, BID and placebo was conducted at a 2-sided alpha level of 0.05 without adjustment for multiplicity.|Mixed Models Analysis|||||0.38|-0.19|0.519
72500879|NCT01381094|144532136|SUPERIORITY||||||=|0.163|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 2).||||=0.1630
72459107|NCT01307800|144440941|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.13|STANDARD_ERROR_OF_MEAN|0.14||0.323|TWO_SIDED|95.0|-0.13|0.4||The comparison between 10 mg LY2140023, BID and placebo was conducted at a 2-sided alpha level of 0.05 without adjustment for multiplicity.|Mixed Models Analysis|||||0.40|-0.13|0.323
72459108|NCT01307800|144440942|SUPERIORITY_OR_OTHER_LEGACY|||||||0.758||95.0||||The comparison between 80 mg LY2140023, BID and placebo in the percentage of participants with a change from baseline in C-SSRS suicidal ideation was conducted at a 2-sided alpha level of 0.05 without adjustment for multiplicity.|Fisher Exact|||||||0.758
72500880|NCT01381094|144532136|SUPERIORITY||||||=|0.7615|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 2).||||=0.7615
72500881|NCT01381094|144532136|SUPERIORITY||||||=|0.004|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 2).||||=0.0040
72459109|NCT01307800|144440942|SUPERIORITY_OR_OTHER_LEGACY|||||||0.576||95.0||||The comparison between 40 mg LY2140023, BID and placebo in the percentage of participants with a change from baseline in C-SSRS suicidal ideation was conducted at a 2-sided alpha level of 0.05 without adjustment for multiplicity.|Fisher Exact|||||||0.576
72500882|NCT01381094|144532136|SUPERIORITY||||||=|0.0003|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 2).||||=0.0003
72500883|NCT01381094|144532136|SUPERIORITY||||||=|0.3978|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 2).||||=0.3978
72500884|NCT01381094|144532136|SUPERIORITY||||||=|0.0083|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 4).||||=0.0083
72563113|NCT00442546|144658154|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.053|STANDARD_ERROR_OF_MEAN|0.07||0.4516||95.0|-0.19|0.085|||ANOVA||Mean difference (final values) = Least squares mean difference|48 hours||0.085|-0.190|0.4516
72563114|NCT00442546|144658154|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.071|STANDARD_ERROR_OF_MEAN|0.069||0.3014||95.0|-0.207|0.064|||ANOVA||Mean difference (final values) = Least squares mean difference|48 hours||0.064|-0.207|0.3014
72620926|NCT00452400|144772836|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.215|STANDARD_ERROR_OF_MEAN|0.029|<|0.0001||95.0|0.159|0.271|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 5 mcg qd minus Placebo|||0.271|0.159|<0.0001
72500885|NCT01381094|144532136|SUPERIORITY||||||=|0.0323|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 4).||||=0.0323
72500886|NCT01381094|144532136|SUPERIORITY||||||=|0.0003|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 4).||||=0.0003
72500887|NCT01381094|144532136|SUPERIORITY||||||=|0.0001|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 4).||||=0.0001
72500888|NCT01381094|144532136|SUPERIORITY||||||=|0.423|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 4).||||=0.4230
72500889|NCT01381094|144532136|SUPERIORITY||||||=|0.0023|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 6).||||=0.0023
72459110|NCT01307800|144440942|SUPERIORITY_OR_OTHER_LEGACY|||||||0.425||95.0||||The comparison between 10 mg LY2140023, BID and placebo in the percentage of participants with a change from baseline in C-SSRS suicidal ideation was conducted at a 2-sided alpha level of 0.05 without adjustment for multiplicity.|Fisher Exact|||||||0.425
72459111|NCT01307800|144440945|SUPERIORITY_OR_OTHER_LEGACY|||||||0.444||95.0||||The comparison between 80 mg LY2140023, BID and placebo was conducted at a 2-sided alpha level of 0.05 without adjustment for multiplicity.|ANOVA|Analysis of variance (ANOVA) model on rank-transformed change.||||||0.444
72459112|NCT01307800|144440945|SUPERIORITY_OR_OTHER_LEGACY|||||||0.799||95.0||||The comparison between 40 mg LY2140023, BID and placebo was conducted at a 2-sided alpha level of 0.05 without adjustment for multiplicity.|ANOVA|ANOVA model on rank-transformed change.||||||0.799
72500890|NCT01381094|144532136|SUPERIORITY||||||=|0.0009|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 6).||||=0.0009
72563115|NCT00442546|144658154|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.023|STANDARD_ERROR_OF_MEAN|0.075||0.7628||95.0|-0.171|0.125|||ANOVA||Mean difference (final values) = Least squares mean difference|72 hours||0.125|-0.171|0.7628
72563116|NCT00442546|144658154|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.028|STANDARD_ERROR_OF_MEAN|0.075||0.711||95.0|-0.176|0.12|||ANOVA||Mean difference (final values) = Least squares mean difference|72 hours||0.120|-0.176|0.7110
72563117|NCT00442546|144658154|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.026|STANDARD_ERROR_OF_MEAN|0.079||0.7382||95.0|-0.183|0.13|||ANOVA||Mean difference (final values) = Least squares mean difference|96 hours||0.130|-0.183|0.7382
72500891|NCT01381094|144532136|SUPERIORITY||||||<|0.0001|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 6).||||<0.0001
72500892|NCT01381094|144532136|SUPERIORITY||||||<|0.0001|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 6).||||<0.0001
72500893|NCT01381094|144532136|SUPERIORITY||||||=|0.5291|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 6).||||=0.5291
72500894|NCT01381094|144532136|SUPERIORITY||||||=|0.0002|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).||||=0.0002
72500895|NCT01381094|144532136|SUPERIORITY||||||=|0.0222|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).||||=0.0222
72500896|NCT01381094|144532136|SUPERIORITY||||||=|0.0002|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).||||=0.0002
72500897|NCT01381094|144532136|SUPERIORITY||||||=|0.0002|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).||||=0.0002
72620927|NCT00452400|144772836|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.218|STANDARD_ERROR_OF_MEAN|0.028|<|0.0001||95.0|0.163|0.273|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 10 mcg qd minus Placebo|||0.273|0.163|<0.0001
72500898|NCT01381094|144532136|SUPERIORITY||||||=|0.9314|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).||||=0.9314
72500899|NCT01381094|144532137|SUPERIORITY||||||=|0.5219|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 1).||||=0.5219
72500900|NCT01381094|144532137|SUPERIORITY||||||=|0.6743|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 1).||||=0.6743
72500901|NCT01381094|144532137|SUPERIORITY||||||=|0.0078|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 1).||||=0.0078
72500902|NCT01381094|144532137|SUPERIORITY||||||=|0.0301|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 1).||||=0.0301
72500903|NCT01381094|144532137|SUPERIORITY||||||=|0.4502|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 1).||||=0.4502
72500904|NCT01381094|144532137|SUPERIORITY||||||=|0.6967|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 2).||||=0.6967
72500905|NCT01381094|144532137|SUPERIORITY||||||=|0.7385|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 2).||||=0.7385
72500906|NCT01381094|144532137|SUPERIORITY||||||=|0.0176|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 2).||||=0.0176
72500907|NCT01381094|144532137|SUPERIORITY||||||=|0.0057|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 2).||||=0.0057
72500908|NCT01381094|144532137|SUPERIORITY||||||=|0.5551|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 2).||||=0.5551
72500909|NCT01381094|144532137|SUPERIORITY||||||=|0.0086|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 4).||||=0.0086
72500910|NCT01381094|144532137|SUPERIORITY||||||=|0.2385|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 4).||||=0.2385
72500911|NCT01381094|144532137|SUPERIORITY||||||=|0.0007|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 4).||||=0.0007
72459113|NCT01307800|144440945|SUPERIORITY_OR_OTHER_LEGACY|||||||0.073||95.0||||The comparison between 10 mg LY2140023, BID and placebo was conducted at a 2-sided alpha level of 0.05 without adjustment for multiplicity.|ANOVA|ANOVA model on rank-transformed change.||||||0.073
72459114|NCT01307800|144440946|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.14|STANDARD_ERROR_OF_MEAN|0.46||0.761|TWO_SIDED|95.0|-0.76|1.04||The comparison between 80 mg LY2140023, BID and placebo was conducted at a 2-sided alpha level of 0.05 without adjustment for multiplicity.|Mixed Models Analysis|||||1.04|-0.76|0.761
72459115|NCT01307800|144440946|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.14|STANDARD_ERROR_OF_MEAN|0.47||0.761|TWO_SIDED|95.0|-0.78|1.06||The comparison between 40 mg LY2140023, BID and placebo was conducted at a 2-sided alpha level of 0.05 without adjustment for multiplicity.|Mixed Models Analysis|||||1.06|-0.78|0.761
72459116|NCT01307800|144440946|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.31|STANDARD_ERROR_OF_MEAN|0.44||0.489|TWO_SIDED|95.0|-1.17|0.56||The comparison between 10 mg LY2140023, BID and placebo was conducted at a 2-sided alpha level of 0.05 without adjustment for multiplicity.|Mixed Models Analysis|||||0.56|-1.17|0.489
72459117|NCT00689351|144440959|SUPERIORITY_OR_OTHER||Ratio of geometric means|0.77|||||TWO_SIDED|95.0|0.62|0.97|||Student t distribution|Geometric mean ratio computed using Student t distribution for the mean difference of the measures on the log scale.|CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).|Serotype 4: Ratio of geometric means (13vPnC, 7vPnC)||0.97|0.62|
72459118|NCT00689351|144440959|SUPERIORITY_OR_OTHER||Ratio of geometric means|1.17|||||TWO_SIDED|95.0|0.87|1.57|||Student t distribution|Geometric mean ratio computed using Student t distribution for the mean difference of the measures on the log scale.|CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).|Serotype 6B: Ratio of geometric means (13vPnC, 7vPnC)||1.57|0.87|
72459119|NCT00689351|144440959|SUPERIORITY_OR_OTHER||Ratio of geometric means|0.88|||||TWO_SIDED|95.0|0.73|1.07|||Student t distribution|Geometric mean ratio computed using Student t distribution for the mean difference of the measures on the log scale.|CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).|Serotype 9V: Ratio of geometric means (13vPnC, 7vPnC)||1.07|0.73|
72459120|NCT00689351|144440959|SUPERIORITY_OR_OTHER||Ratio of geometric means|0.91|||||TWO_SIDED|95.0|0.7|1.19|||Student t distribution|Geometric mean ratio computed using Student t distribution for the mean difference of the measures on the log scale.|CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).|Serotype 14: Ratio of geometric means (13vPnC, 7vPnC)||1.19|0.70|
72500912|NCT01381094|144532137|SUPERIORITY||||||=|0.0002|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 4).||||=0.0002
72459121|NCT00689351|144440959|SUPERIORITY_OR_OTHER||Ratio of geometric means|0.97|||||TWO_SIDED|95.0|0.79|1.18|||Student t distribution|Geometric mean ratio computed using Student t distribution for the mean difference of the measures on the log scale.|CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).|Serotype 18C: Ratio of geometric means (13vPnC, 7vPnC)||1.18|0.79|
72459122|NCT00689351|144440959|SUPERIORITY_OR_OTHER||Ratio of geometric means|0.92|||||TWO_SIDED|95.0|0.71|1.19|||Student t distribution|Geometric mean ratio computed using Student t distribution for the mean difference of the measures on the log scale.|CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).|Serotype 19F: Ratio of geometric means (13vPnC, 7vPnC)||1.19|0.71|
72459123|NCT00689351|144440959|SUPERIORITY_OR_OTHER||Ratio of geometric means|1.04|||||TWO_SIDED|95.0|0.8|1.36|||Student t distribution|Geometric mean ratio computed using Student t distribution for the mean difference of the measures on the log scale.|CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).|Serotype 23F: Ratio of geometric means (13vPnC, 7vPnC)||1.36|0.80|
72459124|NCT00689351|144440959|SUPERIORITY_OR_OTHER||Ratio of geometric means|329.44|||||TWO_SIDED|95.0|242.98|446.67|||Student t distribution|Geometric mean ratio computed using Student t distribution for the mean difference of the measures on the log scale.|CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).|Serotype 1: Ratio of geometric means (13vPnC, 7vPnC)||446.67|242.98|
72459125|NCT00689351|144440959|SUPERIORITY_OR_OTHER||Ratio of geometric means|40.79|||||TWO_SIDED|95.0|30.27|54.97|||Student t distribution|Geometric mean ratio computed using Student t distribution for the mean difference of the measures on the log scale.|CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).|Serotype 3: Ratio of geometric means (13vPnC, 7vPnC)||54.97|30.27|
72500913|NCT01381094|144532137|SUPERIORITY||||||=|0.8895|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 4).||||=0.8895
72500914|NCT01381094|144532137|SUPERIORITY||||||=|0.0127|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 6).||||=0.0127
72500915|NCT01381094|144532137|SUPERIORITY||||||=|0.0076|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 6).||||=0.0076
72459126|NCT00689351|144440959|SUPERIORITY_OR_OTHER||Ratio of geometric means|13.12|||||TWO_SIDED|95.0|9.92|17.34|||Student t distribution|Geometric mean ratio computed using Student t distribution for the mean difference of the measures on the log scale.|CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).|Serotype 5: Ratio of geometric means (13vPnC, 7vPnC)||17.34|9.92|
72459127|NCT00689351|144440959|SUPERIORITY_OR_OTHER||Ratio of geometric means|9.01|||||TWO_SIDED|95.0|6.46|12.56|||Student t distribution|Geometric mean ratio computed using Student t distribution for the mean difference of the measures on the log scale.|CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).|Serotype 6A: Ratio of geometric means (13vPnC, 7vPnC)||12.56|6.46|
72459128|NCT00689351|144440959|SUPERIORITY_OR_OTHER||Ratio of geometric means|165.9|||||TWO_SIDED|95.0|122.95|223.85|||Student t distribution|Geometric mean ratio computed using Student t distribution for the mean difference of the measures on the log scale.|CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).|Serotype 7F: Ratio of geometric means (13vPnC, 7vPnC)||223.85|122.95|
72459129|NCT00689351|144440959|SUPERIORITY_OR_OTHER||Ratio of geometric means|2.24|||||TWO_SIDED|95.0|1.83|2.75|||Student t distribution|Geometric mean ratio computed using Student t distribution for the mean difference of the measures on the log scale.|CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).|Serotype 19A: Ratio of geometric means (13vPnC, 7vPnC)||2.75|1.83|
72459130|NCT00689351|144440960|SUPERIORITY_OR_OTHER||Ratio of geometric means|0.78|||||TWO_SIDED|95.0|0.6|1.02|||Student t distribution|Geometric mean ratio computed using Student t distribution for the mean difference of the measures on the log scale.|CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).|Serotype 4: Ratio of geometric means (13vPnC, 7vPnC)||1.02|0.60|
72459131|NCT00689351|144440960|SUPERIORITY_OR_OTHER||Ratio of geometric means|1.11|||||TWO_SIDED|95.0|0.83|1.48|||Student t distribution|Geometric mean ratio computed using Student t distribution for the mean difference of the measures on the log scale.|CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).|Serotype 6B: Ratio of geometric means (13vPnC, 7vPnC)||1.48|0.83|
72459132|NCT00689351|144440960|SUPERIORITY_OR_OTHER||Ratio of geometric means|0.95|||||TWO_SIDED|95.0|0.76|1.19|||Student t distribution|Geometric mean ratio computed using Student t distribution for the mean difference of the measures on the log scale.|CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).|Serotype 9V: Ratio of geometric means (13vPnC, 7vPnC)||1.19|0.76|
72459133|NCT00689351|144440960|SUPERIORITY_OR_OTHER||Ratio of geometric means|0.74|||||TWO_SIDED|95.0|0.57|0.95|||Student t distribution|Geometric mean ratio computed using Student t distribution for the mean difference of the measures on the log scale.|CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).|Serotype 14: Ratio of geometric means (13vPnC, 7vPnC)||0.95|0.57|
72500916|NCT01381094|144532137|SUPERIORITY||||||=|0.0007|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 6).||||=0.0007
72500917|NCT01381094|144532137|SUPERIORITY||||||<|0.0001|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 6).||||<0.0001
72459134|NCT00689351|144440960|SUPERIORITY_OR_OTHER||Ratio of geometric means|0.92|||||TWO_SIDED|95.0|0.72|1.19|||Student t distribution|Geometric mean ratio computed using Student t distribution for the mean difference of the measures on the log scale.|CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).|Serotype 18C: Ratio of geometric means (13vPnC, 7vPnC)||1.19|0.72|
72500918|NCT01381094|144532137|SUPERIORITY||||||=|0.5522|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 6).||||=0.5522
72500919|NCT01381094|144532137|SUPERIORITY||||||=|0.0031|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).||||=0.0031
72500920|NCT01381094|144532137|SUPERIORITY||||||=|0.2188|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).||||=0.2188
72459135|NCT00689351|144440960|SUPERIORITY_OR_OTHER||Ratio of geometric means|1.45|||||TWO_SIDED|95.0|1.11|1.88|||Student t distribution|Geometric mean ratio computed using Student t distribution for the mean difference of the measures on the log scale.|CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).|Serotype 19F: Ratio of geometric means (13vPnC, 7vPnC)||1.88|1.11|
72459136|NCT00689351|144440960|SUPERIORITY_OR_OTHER||Ratio of geometric means|1.05|||||TWO_SIDED|95.0|0.78|1.4|||Student t distribution|Geometric mean ratio computed using Student t distribution for the mean difference of the measures on the log scale.|CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).|Serotype 23F: Ratio of geometric means (13vPnC, 7vPnC)||1.40|0.78|
72500921|NCT01381094|144532137|SUPERIORITY||||||=|0.0054|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).||||=0.0054
72459137|NCT00689351|144440960|SUPERIORITY_OR_OTHER||Ratio of geometric means|234.33|||||TWO_SIDED|95.0|176.33|311.41|||Student t distribution|Geometric mean ratio computed using Student t distribution for the mean difference of the measures on the log scale.|CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).|Serotype 1: Ratio of geometric means (13vPnC, 7vPnC)||311.41|176.33|
72459138|NCT00689351|144440960|SUPERIORITY_OR_OTHER||Ratio of geometric means|16.63|||||TWO_SIDED|95.0|12.19|22.69|||Student t distribution|Geometric mean ratio computed using Student t distribution for the mean difference of the measures on the log scale.|CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).|Serotype 3: Ratio of geometric means (13vPnC, 7vPnC)||22.69|12.19|
72500922|NCT01381094|144532137|SUPERIORITY||||||=|0.0037|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).||||=0.0037
72500923|NCT01381094|144532137|SUPERIORITY||||||=|0.9521|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).||||=0.9521
72500924|NCT01381094|144532138|SUPERIORITY||||||=|0.3943|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 1).||||=0.3943
72500925|NCT01381094|144532138|SUPERIORITY||||||=|0.2096|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 1).||||=0.2096
72563118|NCT00442546|144658154|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.034|STANDARD_ERROR_OF_MEAN|0.076||0.6586||95.0|-0.183|0.116|||ANOVA||Mean difference (final values) = Least squares mean difference|96 hours||0.116|-0.183|0.6586
72563119|NCT00442546|144658154|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.025|STANDARD_ERROR_OF_MEAN|0.084||0.7691||95.0|-0.195|0.145|||ANOVA||Mean difference (final values) = Least squares mean difference|120 hours||0.145|-0.195|0.7691
72563120|NCT00442546|144658154|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.057|STANDARD_ERROR_OF_MEAN|0.085||0.507||95.0|-0.229|0.115|||ANOVA||Mean difference (final values) = Least squares mean difference|120 hours||0.115|-0.229|0.5070
72563121|NCT00442546|144658154|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.036|STANDARD_ERROR_OF_MEAN|0.066||0.5802||95.0|-0.166|0.093|||ANOVA||Mean difference (final values) = Least squares mean difference|Discharge||0.093|-0.166|0.5802
72563122|NCT00442546|144658154|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.007|STANDARD_ERROR_OF_MEAN|0.065||0.919||95.0|-0.122|0.136|||ANOVA||Mean difference (final values) = Least squares mean difference|Discharge||0.136|-0.122|0.9190
72500926|NCT01381094|144532138|SUPERIORITY||||||=|0.0637|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 1).||||=0.0637
72500927|NCT01381094|144532138|SUPERIORITY||||||=|0.5016|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 1).||||=0.5016
72563123|NCT00442546|144658154|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.026|STANDARD_ERROR_OF_MEAN|0.059||0.6559||95.0|-0.09|0.143|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2||0.143|-0.090|0.6559
72563124|NCT00442546|144658154|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.011|STANDARD_ERROR_OF_MEAN|0.06||0.8552||95.0|-0.108|0.13|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2||0.130|-0.108|0.8552
72563125|NCT00442546|144658154|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.023|STANDARD_ERROR_OF_MEAN|0.048||0.6364||95.0|-0.072|0.117|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4||0.117|-0.072|0.6364
72459139|NCT00689351|144440960|SUPERIORITY_OR_OTHER||Ratio of geometric means|6.84|||||TWO_SIDED|95.0|5.39|8.67|||Student t distribution|Geometric mean ratio computed using Student t distribution for the mean difference of the measures on the log scale.|CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).|Serotype 5: Ratio of geometric means (13vPnC, 7vPnC)||8.67|5.39|
72563126|NCT00442546|144658154|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.061|STANDARD_ERROR_OF_MEAN|0.049||0.2127||95.0|-0.035|0.157|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4||0.157|-0.035|0.2127
72563127|NCT00442546|144658154|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.007|STANDARD_ERROR_OF_MEAN|0.047||0.8746||95.0|-0.086|0.101|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET||0.101|-0.086|0.8746
72459140|NCT00689351|144440960|SUPERIORITY_OR_OTHER||Ratio of geometric means|4.08|||||TWO_SIDED|95.0|3.07|5.43|||Student t distribution|Geometric mean ratio computed using Student t distribution for the mean difference of the measures on the log scale.|CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).|Serotype 6A: Ratio of geometric means (13vPnC, 7vPnC)||5.43|3.07|
72563128|NCT00442546|144658154|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.107|STANDARD_ERROR_OF_MEAN|0.048||0.0286||95.0|0.011|0.202|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET||0.202|0.011|0.0286
72563129|NCT00442546|144658155|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.165|STANDARD_ERROR_OF_MEAN|0.102||0.1078||95.0|-0.367|0.036|||ANOVA||Mean difference (final values) = Least squares mean difference|24 hours||0.036|-0.367|0.1078
72563130|NCT00442546|144658155|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.048|STANDARD_ERROR_OF_MEAN|0.103||0.6406||95.0|-0.252|0.155|||ANOVA||Mean difference (final values) = Least squares mean difference|24 hours||0.155|-0.252|0.6406
72500928|NCT01381094|144532138|SUPERIORITY||||||=|0.7549|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 1).||||=0.7549
72563131|NCT00442546|144658155|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.108|STANDARD_ERROR_OF_MEAN|0.092||0.2404||95.0|-0.289|0.073|||ANOVA||Mean difference (final values) = Least squares mean difference|48 hours||0.073|-0.289|0.2404
72459141|NCT00689351|144440960|SUPERIORITY_OR_OTHER||Ratio of geometric means|110.92|||||TWO_SIDED|95.0|77.09|159.59|||Student t distribution|Geometric mean ratio computed using Student t distribution for the mean difference of the measures on the log scale.|CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).|Serotype 7F: Ratio of geometric means (13vPnC, 7vPnC)||159.59|77.09|
72459142|NCT00689351|144440960|SUPERIORITY_OR_OTHER||Ratio of geometric means|4.25|||||TWO_SIDED|95.0|3.39|5.33|||Student t distribution|Geometric mean ratio computed using Student t distribution for the mean difference of the measures on the log scale.|CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).|Serotype 19A: Ratio of geometric means (13vPnC, 7vPnC)||5.33|3.39|
72459143|NCT00689351|144440961|SUPERIORITY_OR_OTHER|||||||0.862|||||||Fisher Exact|||Comparison between treatments for any tenderness.||||0.862
72500929|NCT01381094|144532138|SUPERIORITY||||||=|0.5991|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 2).||||=0.5991
72500930|NCT01381094|144532138|SUPERIORITY||||||=|0.4258|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 2).||||=0.4258
72500931|NCT01381094|144532138|SUPERIORITY||||||=|0.0336|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 2).||||=0.0336
72563132|NCT00442546|144658155|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.149|STANDARD_ERROR_OF_MEAN|0.09||0.1005||95.0|-0.327|0.029|||ANOVA||Mean difference (final values) = Least squares mean difference|48 hours||0.029|-0.327|0.1005
72620928|NCT00452400|144772836|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.247|STANDARD_ERROR_OF_MEAN|0.029|<|0.0001||95.0|0.191|0.304|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 20 mcg qd minus Placebo|||0.304|0.191|<0.0001
72563133|NCT00442546|144658155|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.136|STANDARD_ERROR_OF_MEAN|0.108||0.2109||95.0|-0.349|0.078|||ANOVA||Mean difference (final values) = Least squares mean difference|72 hours||0.078|-0.349|0.2109
72459144|NCT00689351|144440961|SUPERIORITY_OR_OTHER|||||||0.157|||||||Fisher Exact|||Comparison between treatments for significant tenderness.||||0.157
72459145|NCT00689351|144440961|SUPERIORITY_OR_OTHER|||||||0.55|||||||Fisher Exact|||Comparison between treatments for any swelling.||||0.550
72459146|NCT00689351|144440961|SUPERIORITY_OR_OTHER|||||||0.052|||||||Fisher Exact|||Comparison between treatments for mild swelling.||||0.052
72459147|NCT00689351|144440961|SUPERIORITY_OR_OTHER|||||||0.366|||||||Fisher Exact|||Comparison between treatments for moderate swelling.||||0.366
72459148|NCT00689351|144440961|SUPERIORITY_OR_OTHER|||||||0.301|||||||Fisher Exact|||Comparison between treatments for any redness.||||0.301
72459149|NCT00689351|144440961|SUPERIORITY_OR_OTHER|||||||0.362|||||||Fisher Exact|||Comparison between treatments for mild redness.||||0.362
72459150|NCT00689351|144440961|SUPERIORITY_OR_OTHER|||||||0.718|||||||Fisher Exact|||Comparison between treatments for moderate redness.||||0.718
72459151|NCT00689351|144440962|SUPERIORITY_OR_OTHER||||||>|0.99|||||||Fisher Exact|||Comparison between treatments for any tenderness.||||>0.99
72459152|NCT00689351|144440962|SUPERIORITY_OR_OTHER|||||||0.245|||||||Fisher Exact|||Comparison between treatments for significant tenderness.||||0.245
72459153|NCT00689351|144440962|SUPERIORITY_OR_OTHER|||||||0.447|||||||Fisher Exact|||Comparison between treatments for any swelling.||||0.447
72459154|NCT00689351|144440962|SUPERIORITY_OR_OTHER|||||||0.684|||||||Fisher Exact|||Comparison between treatments for mild swelling.||||0.684
72500932|NCT01381094|144532138|SUPERIORITY||||||=|0.0258|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 2).||||=0.0258
72563134|NCT00442546|144658155|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.128|STANDARD_ERROR_OF_MEAN|0.108||0.2399||95.0|-0.342|0.086|||ANOVA||Mean difference (final values) = Least squares mean difference|72 hours||0.086|-0.342|0.2399
72563135|NCT00442546|144658155|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.131|STANDARD_ERROR_OF_MEAN|0.108||0.2272||95.0|-0.346|0.083|||ANOVA||Mean difference (final values) = Least squares mean difference|96 hours||0.083|-0.346|0.2272
72563136|NCT00442546|144658155|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.08|STANDARD_ERROR_OF_MEAN|0.104||0.4417||95.0|-0.285|0.125|||ANOVA||Mean difference (final values) = Least squares mean difference|96 hours||0.125|-0.285|0.4417
72563137|NCT00442546|144658155|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.009|STANDARD_ERROR_OF_MEAN|0.144||0.9502||95.0|-0.299|0.281|||ANOVA||Mean difference (final values) = Least squares mean difference|120 hours||0.281|-0.299|0.9502
72563138|NCT00442546|144658155|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.135|STANDARD_ERROR_OF_MEAN|0.144||0.355||95.0|-0.426|0.156|||ANOVA||Mean difference (final values) = Least squares mean difference|120 hours||0.156|-0.426|0.3550
72563139|NCT00442546|144658155|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.122|STANDARD_ERROR_OF_MEAN|0.092||0.1888||95.0|-0.304|0.06|||ANOVA||Mean difference (final values) = Least squares mean difference|Discharge||0.060|-0.304|0.1888
72563140|NCT00442546|144658155|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.081|STANDARD_ERROR_OF_MEAN|0.092||0.3774||95.0|-0.262|0.1|||ANOVA||Mean difference (final values) = Least squares mean difference|Discharge||0.100|-0.262|0.3774
72500933|NCT01381094|144532138|SUPERIORITY||||||=|0.2412|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 2).||||=0.2412
72500934|NCT01381094|144532138|SUPERIORITY||||||=|0.0031|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 4).||||=0.0031
72500935|NCT01381094|144532138|SUPERIORITY||||||=|0.7705|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 4).||||=0.7705
72500936|NCT01381094|144532138|SUPERIORITY||||||=|0.0024|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 4).||||=0.0024
72459155|NCT00689351|144440962|SUPERIORITY_OR_OTHER||||||>|0.99|||||||Fisher Exact|||Comparison between treatments for moderate swelling.||||>0.99
72459156|NCT00689351|144440962|SUPERIORITY_OR_OTHER|||||||0.578|||||||Fisher Exact|||Comparison between treatments for any redness.||||0.578
72459157|NCT00689351|144440962|SUPERIORITY_OR_OTHER|||||||0.451|||||||Fisher Exact|||Comparison between treatments for mild redness.||||0.451
72459158|NCT00689351|144440962|SUPERIORITY_OR_OTHER|||||||0.712|||||||Fisher Exact|||Comparison between treatments for moderate redness.||||0.712
72459159|NCT00689351|144440963|SUPERIORITY_OR_OTHER|||||||0.681|||||||Fisher Exact|||Comparison between treatments for any tenderness.||||0.681
72459160|NCT00689351|144440963|SUPERIORITY_OR_OTHER|||||||0.482|||||||Fisher Exact|||Comparison between treatments for significant tenderness.||||0.482
72459161|NCT00689351|144440963|SUPERIORITY_OR_OTHER|||||||0.683|||||||Fisher Exact|||Comparison between treatments for any swelling.||||0.683
72500937|NCT01381094|144532138|SUPERIORITY||||||=|0.0006|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 4).||||=0.0006
72620929|NCT00452400|144772837|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.159|STANDARD_ERROR_OF_MEAN|0.03|<|0.0001||95.0|0.1|0.219|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 2 mcg qd minus Placebo|||0.219|0.100|<0.0001
72459162|NCT00689351|144440963|SUPERIORITY_OR_OTHER||||||>|0.99|||||||Fisher Exact|||Comparison between treatments for mild swelling.||||>0.99
72500938|NCT01381094|144532138|SUPERIORITY||||||=|0.6189|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 4).||||=0.6189
72500939|NCT01381094|144532138|SUPERIORITY||||||=|0.0075|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 6).||||=0.0075
72500940|NCT01381094|144532138|SUPERIORITY||||||=|0.0259|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 6).||||=0.0259
72500941|NCT01381094|144532138|SUPERIORITY||||||<|0.0001|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 6).||||<0.0001
72620930|NCT00452400|144772837|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.194|STANDARD_ERROR_OF_MEAN|0.03|<|0.0001||95.0|0.134|0.253|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 5 mcg qd minus Placebo|||0.253|0.134|<0.0001
72459163|NCT00689351|144440963|SUPERIORITY_OR_OTHER|||||||0.533|||||||Fisher Exact|||Comparison between treatments for moderate swelling.||||0.533
72459164|NCT00689351|144440963|SUPERIORITY_OR_OTHER|||||||0.692|||||||Fisher Exact|||Comparison between treatments for any redness.||||0.692
72459165|NCT00689351|144440963|SUPERIORITY_OR_OTHER|||||||0.662|||||||Fisher Exact|||Comparison between treatments for mild redness.||||0.662
72459166|NCT00689351|144440963|SUPERIORITY_OR_OTHER|||||||0.331|||||||Fisher Exact|||Comparison between treatments for moderate redness.||||0.331
72459167|NCT00689351|144440964|SUPERIORITY_OR_OTHER|||||||0.409|||||||Fisher Exact|||Comparison between treatments for any tenderness.||||0.409
72459168|NCT00689351|144440964|SUPERIORITY_OR_OTHER|||||||0.617|||||||Fisher Exact|||Comparison between treatments for significant tenderness.||||0.617
72459169|NCT00689351|144440964|SUPERIORITY_OR_OTHER|||||||0.807|||||||Fisher Exact|||Comparison between treatments for any swelling.||||0.807
72459170|NCT00689351|144440964|SUPERIORITY_OR_OTHER|||||||0.527|||||||Fisher Exact|||Comparison between treatments for mild swelling.||||0.527
72459171|NCT00689351|144440964|SUPERIORITY_OR_OTHER|||||||0.144|||||||Fisher Exact|||Comparison between treatments for moderate swelling.||||0.144
72459172|NCT00689351|144440964|SUPERIORITY_OR_OTHER|||||||0.495|||||||Fisher Exact|||Comparison between treatments for severe swelling.||||0.495
72459173|NCT00689351|144440964|SUPERIORITY_OR_OTHER|||||||0.506|||||||Fisher Exact|||Comparison between treatments for any redness.||||0.506
72459174|NCT00689351|144440964|SUPERIORITY_OR_OTHER||||||>|0.99|||||||Fisher Exact|||Comparison between treatments for mild redness.||||>0.99
72459175|NCT00689351|144440964|SUPERIORITY_OR_OTHER|||||||0.2|||||||Fisher Exact|||Comparison between treatments for moderate redness.||||0.200
72459176|NCT00689351|144440965|SUPERIORITY_OR_OTHER|||||||0.633|||||||Fisher Exact|||Comparison between treatments for fever ≥38 degrees C but but less than or equal to (≤)39 degrees C.||||0.633
72459177|NCT00689351|144440965|SUPERIORITY_OR_OTHER|||||||0.721|||||||Fisher Exact|||Comparison between treatments for decreased appetite.||||0.721
72459178|NCT00689351|144440965|SUPERIORITY_OR_OTHER|||||||0.009|||||||Fisher Exact|||Comparison between treatments for irritability.||||0.009
72459179|NCT00689351|144440965|SUPERIORITY_OR_OTHER|||||||0.253|||||||Fisher Exact|||Comparison between treatments for increased sleep.||||0.253
72459180|NCT00689351|144440965|SUPERIORITY_OR_OTHER|||||||0.143|||||||Fisher Exact|||Comparison between treatments for decreased sleep.||||0.143
72459181|NCT00689351|144440966|SUPERIORITY_OR_OTHER|||||||0.781|||||||Fisher Exact|||Comparison between treatments for fever ≥38 degrees C but ≤39 degrees C.||||0.781
72459182|NCT00689351|144440966|SUPERIORITY_OR_OTHER|||||||0.06|||||||Fisher Exact|||Comparison between treatments for decreased appetite.||||0.060
72459183|NCT00689351|144440966|SUPERIORITY_OR_OTHER|||||||0.159|||||||Fisher Exact|||Comparison between treatments for irritability.||||0.159
72459184|NCT00689351|144440966|SUPERIORITY_OR_OTHER|||||||0.839|||||||Fisher Exact|||Comparison between treatments for increased sleep.||||0.839
72459185|NCT00689351|144440966|SUPERIORITY_OR_OTHER|||||||0.264|||||||Fisher Exact|||Comparison between treatments for decreased sleep.||||0.264
72459186|NCT00689351|144440967|SUPERIORITY_OR_OTHER|||||||0.563|||||||Fisher Exact|||Comparison between treatments for fever ≥38 degrees C but ≤39 degrees C.||||0.563
72459187|NCT00689351|144440967|SUPERIORITY_OR_OTHER|||||||0.468|||||||Fisher Exact|||Comparison between treatments for fever \>39 degrees C but ≤40 degrees C.||||0.468
72459188|NCT00689351|144440967|SUPERIORITY_OR_OTHER|||||||0.535|||||||Fisher Exact|||Comparison between treatments for decreased appetite.||||0.535
72459189|NCT00689351|144440967|SUPERIORITY_OR_OTHER|||||||0.019|||||||Fisher Exact|||Comparison between treatments for irritability.||||0.019
72459190|NCT00689351|144440967|SUPERIORITY_OR_OTHER|||||||0.398|||||||Fisher Exact|||Comparison between treatments for increased sleep.||||0.398
72459191|NCT00689351|144440967|SUPERIORITY_OR_OTHER|||||||0.125|||||||Fisher Exact|||Comparison between treatments for decreased sleep.||||0.125
72459192|NCT00689351|144440968|SUPERIORITY_OR_OTHER|||||||0.596|||||||Fisher Exact|||Comparison between treatments for fever ≥38 degrees C but ≤39 degrees C.||||0.596
72459193|NCT00689351|144440968|SUPERIORITY_OR_OTHER||||||>|0.99|||||||Fisher Exact|||Comparison between treatments for fever \>39 degrees C but ≤40 degrees C.||||>0.99
72459194|NCT00689351|144440968|SUPERIORITY_OR_OTHER|||||||0.663|||||||Fisher Exact|||Comparison between treatments for decreased appetite.||||0.663
72459195|NCT00689351|144440968|SUPERIORITY_OR_OTHER|||||||0.439|||||||Fisher Exact|||Comparison between treatments for irritability.||||0.439
72459196|NCT00689351|144440968|SUPERIORITY_OR_OTHER|||||||0.613|||||||Fisher Exact|||Comparison between treatments for increased sleep.||||0.613
72459197|NCT00689351|144440968|SUPERIORITY_OR_OTHER|||||||0.138|||||||Fisher Exact|||Comparison between treatments for decreased sleep.||||0.138
72459198|NCT01020487|144440996|SUPERIORITY_OR_OTHER||Difference|27.8||||0.045|TWO_SIDED|95.0|7.5|52.8|||Fisher Exact|||Treatment effects were evaluated based on a two-sided significance level of 0.050. The primary efficacy analysis was a comparison between the paricalcitol capsules and placebo groups in the percentage of participants achieving 2 consecutive ≥ 30% reductions in iPTH from baseline regardless of CKD stage conducted using Fisher's exact test.||52.8|7.5|0.045
72459199|NCT01020487|144440997|SUPERIORITY_OR_OTHER|||||||0.128|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CHM) test, adjusting for CKD Stage.||||||0.128
72459200|NCT01020487|144440998|SUPERIORITY_OR_OTHER||Differenbce|-72.4|||<|0.001|TWO_SIDED|95.0|-108.05|-36.75|||Mixed Models Analysis|||Overall Comparison (all time points): A mixed effects repeated measures analysis using all the longitudinal observations across the visits including the fixed categorical effects of treatment, visit, and treatment-by-visit interaction, and the continuous covariate of baseline measurement.||-36.75|-108.05|< 0.001
72459201|NCT01020487|144440998|SUPERIORITY_OR_OTHER||Difference|-62.55||||0.006|TWO_SIDED|95.0|-105.6|-19.49|||Mixed Models Analysis|||Week 2 Comparison: a mixed effects repeated measures analysis using all the longitudinal observations across the visits including the fixed categorical effects of treatment, visit, and treatment-by-visit interaction, and the continuous covariate of baseline measurement.||-19.49|-105.60|0.006
72459202|NCT01020487|144440998|SUPERIORITY_OR_OTHER||Difference|-68.43||||0.032|TWO_SIDED|95.0|-130.39|-6.47|||Mixed Models Analysis|||Week 4 Comparison: a mixed effects repeated measures analysis using all the longitudinal observations across the visits including the fixed categorical effects of treatment, visit, and treatment-by-visit interaction, and the continuous covariate of baseline measurement.||-6.47|-130.39|0.032
72459203|NCT01020487|144440998|SUPERIORITY_OR_OTHER||Difference|-70.09||||0.043|TWO_SIDED|95.0|-137.82|-2.37|||Mixed Models Analysis|||Week 8 Comparison: A mixed effects repeated measures analysis using all the longitudinal observations across the visits including the fixed categorical effects of treatment, visit, and treatment-by-visit interaction, and the continuous covariate of baseline measurement.||-2.37|-137.82|0.043
72459204|NCT01020487|144440998|SUPERIORITY_OR_OTHER||Difference|-88.52||||0.002|TWO_SIDED|95.0|-142.04|-35.01|||Mixed Models Analysis|||Week 12 Comparison: A mixed effects repeated measures analysis using all the longitudinal observations across the visits including the fixed categorical effects of treatment, visit, and treatment-by-visit interaction, and the continuous covariate of baseline measurement.||-35.01|-142.04|0.002
72459205|NCT01020487|144440999|SUPERIORITY_OR_OTHER|||||||0.327|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CHM) test, adjusting for CKD Stage.||||||0.327
72459206|NCT01020487|144441000|SUPERIORITY_OR_OTHER|||||||0.194|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CHM) test, adjusting for CKD Stage.||||||0.194
72459207|NCT01020487|144441001|SUPERIORITY_OR_OTHER||Difference|0.14||||0.469|TWO_SIDED|95.0|-0.25|0.53|||Mixed Models Analysis|||Overall Comparison (all time points): a mixed effects repeated measures analysis using all the longitudinal observations across the visits including the fixed categorical effects of treatment, visit, and treatment-by-visit interaction, and the continuous covariate of baseline measurement||0.53|-0.25|0.469
72459208|NCT01020487|144441001|SUPERIORITY_OR_OTHER||Difference|-0.01||||0.975|TWO_SIDED|95.0|-0.39|0.37|||Mixed Models Analysis|||Week 4 Comparison: a mixed effects repeated measures analysis using all the longitudinal observations across the visits including the fixed categorical effects of treatment, visit, and treatment-by-visit interaction, and the continuous covariate of baseline measurement.||0.37|-0.39|0.975
72459209|NCT01020487|144441001|SUPERIORITY_OR_OTHER||Difference|0.12||||0.567|TWO_SIDED|95.0|-0.32|0.56|||Mixed Models Analysis|||Week 8 Comparison: a mixed effects repeated measures analysis using all the longitudinal observations across the visits including the fixed categorical effects of treatment, visit, and treatment-by-visit interaction, and the continuous covariate of baseline measurement||0.56|-0.32|0.567
72459210|NCT01020487|144441001|SUPERIORITY_OR_OTHER||Difference|0.3||||0.462|TWO_SIDED|95.0|-0.53|1.12|||Mixed Models Analysis|||Week 12 Comparison: a mixed effects repeated measures analysis using all the longitudinal observations across the visits including the fixed categorical effects of treatment, visit, and treatment-by-visit interaction, and the continuous covariate of baseline measurement||1.12|-0.53|0.462
72459211|NCT00988429|144441085|SUPERIORITY_OR_OTHER_LEGACY|||||||0.058||95.0|||||ANCOVA|||||||0.058
72459212|NCT00988429|144441085|SUPERIORITY_OR_OTHER_LEGACY|||||||0.004||95.0|||||ANCOVA|||||||0.004
72459213|NCT00988429|144441086|SUPERIORITY_OR_OTHER_LEGACY|||||||0.068|||||||ANCOVA|||||||0.068
72500942|NCT01381094|144532138|SUPERIORITY||||||<|0.0001|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 6).||||<0.0001
72500943|NCT01381094|144532138|SUPERIORITY||||||=|0.8898|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 6).||||=0.8898
72500944|NCT01381094|144532138|SUPERIORITY||||||=|0.001|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).||||=0.0010
72500945|NCT01381094|144532138|SUPERIORITY||||||=|0.2864|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).||||=0.2864
72500946|NCT01381094|144532138|SUPERIORITY||||||=|0.0002|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).||||=0.0002
72500947|NCT01381094|144532138|SUPERIORITY||||||=|0.0016|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).||||=0.0016
72500948|NCT01381094|144532138|SUPERIORITY||||||=|0.9697|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).||||=0.9697
72500949|NCT01381094|144532139|SUPERIORITY||||||=|1|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 1).||||=1.0000
72500950|NCT01381094|144532139|SUPERIORITY||||||=|0.0055|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 1).||||=0.0055
72500951|NCT01381094|144532139|SUPERIORITY||||||=|0.0009|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 1).||||=0.0009
72370506|NCT00488683|144251632|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|0.27||||0.12||95.0|||||Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one month after booster vaccination for the serogroup W-135||||0.12
72500952|NCT01381094|144532139|SUPERIORITY||||||=|0.0002|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 1).||||=0.0002
72500953|NCT01381094|144532139|SUPERIORITY||||||=|0.9722|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 1).||||=0.9722
72500954|NCT01381094|144532139|SUPERIORITY||||||=|1|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 2).||||=1.0000
72500955|NCT01381094|144532139|SUPERIORITY||||||=|0.0008|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 2).||||=0.0008
72459214|NCT00988429|144441086|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|||||||ANCOVA|||||||0.001
72459215|NCT02964234|144441087|SUPERIORITY||Odds Ratio (OR)|10.59||||0.005|TWO_SIDED|95.0|2.01|56.31||We clustered by cohort, given both interventions used a group format, and adjusted for age, socioeconomic status (education, income, insurance status) baseline mammography history, and baseline mammography intention.|Regression, Logistic|||We conducted logistic regressions, clustering by cohort, given both interventions used a group format, and adjusting for age, education, income, insurance status, baseline mammography history, and baseline mammography intention. The null hypothesis was there would be no study arm differences. A priori power analysis suggested that a sample size of 150, assuming alpha = .05, power = .80 would lead us to detect medium/large effects (OR = 2.8).||56.31|2.01|.005
72459216|NCT02964234|144441088|SUPERIORITY||Slope|-0.19||||0.03|TWO_SIDED|95.0|-0.34|-0.04|||Regression, Linear|With GEE. Models had exchangeable correlation structure, a gamma distribution, and log link.||Analyses were conducted using GEE with an exchangeable correlation structure and a gamma distribution with log link. All models included study arm, time, and the study arm\*time. Covariates included age, education, and mammography history. With 150 Latinas, alpha = 0.05, power = 0.80, ICC = 0.0-0.05, we expected to detect small/medium interaction effects.||-0.04|-0.34|0.03
72500956|NCT01381094|144532139|SUPERIORITY||||||=|0.0002|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 2).||||=0.0002
72500957|NCT01381094|144532139|SUPERIORITY||||||<|0.0001|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 2).||||<0.0001
72500958|NCT01381094|144532139|SUPERIORITY||||||=|0.6579|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 2).||||=0.6579
72500959|NCT01381094|144532139|SUPERIORITY||||||=|0.4102|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 4).||||=0.4102
72500960|NCT01381094|144532139|SUPERIORITY||||||=|0.0023|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 4).||||=0.0023
72500961|NCT01381094|144532139|SUPERIORITY||||||=|0.0052|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 4).||||=0.0052
72500962|NCT01381094|144532139|SUPERIORITY||||||=|0.0017|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 4).||||=0.0017
72500963|NCT01381094|144532139|SUPERIORITY||||||=|0.7378|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 4).||||=0.7378
72500964|NCT01381094|144532139|SUPERIORITY||||||=|0.3371|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 6).||||=0.3371
72500965|NCT01381094|144532139|SUPERIORITY||||||=|0.0916|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 6).||||=0.0916
72563141|NCT00442546|144658155|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.006|STANDARD_ERROR_OF_MEAN|0.087||0.9452||95.0|-0.178|0.166|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2||0.166|-0.178|0.9452
72563142|NCT00442546|144658155|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.026|STANDARD_ERROR_OF_MEAN|0.089||0.7663||95.0|-0.201|0.148|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2||0.148|-0.201|0.7663
72500966|NCT01381094|144532139|SUPERIORITY||||||=|0.4656|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 6).||||=0.4656
72500967|NCT01381094|144532139|SUPERIORITY||||||=|0.1629|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 6).||||=0.1629
72500968|NCT01381094|144532139|SUPERIORITY||||||=|0.7032|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 6).||||=0.7032
72500969|NCT01381094|144532139|SUPERIORITY||||||=|0.5194|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).||||=0.5194
72500970|NCT01381094|144532139|SUPERIORITY||||||=|0.8516|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).||||=0.8516
72500971|NCT01381094|144532139|SUPERIORITY||||||=|0.0017|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).||||=0.0017
72563143|NCT00442546|144658155|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.041|STANDARD_ERROR_OF_MEAN|0.074||0.5777||95.0|-0.104|0.186|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4||0.186|-0.104|0.5777
72563144|NCT00442546|144658155|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.079|STANDARD_ERROR_OF_MEAN|0.075||0.2916||95.0|-0.069|0.227|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4||0.227|-0.069|0.2916
72563145|NCT00442546|144658155|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.014|STANDARD_ERROR_OF_MEAN|0.069||0.8389||95.0|-0.15|0.122|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET||0.122|-0.150|0.8389
72563146|NCT00442546|144658155|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.127|STANDARD_ERROR_OF_MEAN|0.07||0.0734||95.0|-0.012|0.266|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET||0.266|-0.012|0.0734
72563147|NCT00442546|144658156|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.11|STANDARD_ERROR_OF_MEAN|0.084||0.1949||95.0|-0.276|0.057|||ANOVA||Mean difference (final values) = Least squares mean difference|24 hours||0.057|-0.276|0.1949
72563148|NCT00442546|144658156|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.052|STANDARD_ERROR_OF_MEAN|0.085||0.5431||95.0|-0.22|0.116|||ANOVA||Mean difference (final values) = Least squares mean difference|24 hours||0.116|-0.220|0.5431
72563149|NCT00442546|144658156|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.095|STANDARD_ERROR_OF_MEAN|0.077||0.2164||95.0|-0.247|0.056|||ANOVA||Mean difference (final values) = Least squares mean difference|48 hours||0.056|-0.247|0.2164
72563150|NCT00442546|144658156|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.117|STANDARD_ERROR_OF_MEAN|0.076||0.1251||95.0|-0.266|0.033|||ANOVA||Mean difference (final values) = Least squares mean difference|48 hours||0.033|-0.266|0.1251
72563151|NCT00442546|144658156|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.073|STANDARD_ERROR_OF_MEAN|0.088||0.4079||95.0|-0.247|0.101|||ANOVA||Mean difference (final values) = Least squares mean difference|72 hours||0.101|-0.247|0.4079
72563152|NCT00442546|144658156|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.066|STANDARD_ERROR_OF_MEAN|0.088||0.4562||95.0|-0.24|0.108|||ANOVA||Mean difference (final values) = Least squares mean difference|72 hours||0.108|-0.240|0.4562
72370507|NCT00488683|144251632|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|0.25||||0.09||95.0|||||Parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Pearson correlation coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one month after booster vaccination for the serogroup W-135||||0.09
72459217|NCT02964234|144441089|SUPERIORITY||Odds Ratio (OR)|6.15|||<|0.0001|TWO_SIDED|95.0|2.82|13.32||Analyses clustered by cohort and adjusted for age, SES (education, income, insurance), mammography history, mammography intention, and baseline supportive breast cancer social network size.|Ordinal regression|||We used ordinal regression, given the non-normal distribution revealed by preliminary analyses. Analyses clustered by cohort and adjusted for age, SES (education, income, insurance), mammography history, mammography intention, and baseline supportive breast cancer social network size. Power analyses suggested that with 150 Latinas, alpha = .05, power = .80, we would be able to detect a small effect (Cohen's f = 0.05).||13.32|2.82|<0.0001
72459218|NCT01074229|144441090|SUPERIORITY_OR_OTHER|||||||0.05|||||||Kruskal-Wallis|Using Dunns test with Bonferroni conrrection for individual comparisons.||||||.05
72459219|NCT01074229|144441090|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|28.0||||0.05|TWO_SIDED|95.0|9.0|37.0|||Dunns test|Bonferonni correction||||37|9|.05
72459220|NCT01074229|144441090|SUPERIORITY_OR_OTHER||Mean Difference (Net)|28.0||||0.05|TWO_SIDED|95.0|14.0|42.0|||Dunns Test|Bonferroni correction||||42|14|.05
72459221|NCT01074229|144441091|SUPERIORITY_OR_OTHER|||||||0.05|||||||Kruskal-Wallis|With Dunns test and Bonferonni correction.||||||.05
72459222|NCT01074229|144441091|SUPERIORITY_OR_OTHER||Median Difference (Net)|10.0||||0.003|TWO_SIDED|95.0|3.0|15.0|||Dunns test|||||15|3|0.003
72459223|NCT01074229|144441091|SUPERIORITY_OR_OTHER||Mean Difference (Net)|5.0||||0.14|TWO_SIDED|95.0|-1.0|12.0|||Dunns test|||||12|-1|0.14
72459224|NCT00234832|144441092|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.162||||0.015|TWO_SIDED|95.0|1.029|1.311||No adjustment for multiple testing or interim analysis was performed. The primary outcome was tested at a 2-sided alpha level of 0.05.|Log Rank||The Cox model included factors for treatment, country, gender, and age (continuous) at Lead-in Period baseline. For the calculation of risk, the sibutramine arm is the numerator and the placebo arm is the denominator.|For the sample size calculation, a two-tailed alpha level of 0.05 was used along with power of 90%. The annual composite event rate in the placebo arm was assumed to be 7.0%. A sample of 3983 subjects in each of the 2 groups, corrected for a 30% noncompliance rate (15% in Year 1 and 6.3% in each year, Years 2 to 4), followed for at least 3 years was expected to have 90% power to detect a relative risk reduction of 15% with sibutramine relative to placebo.||1.311|1.029|0.015
72459225|NCT00234832|144441092|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.01||||0.948|TWO_SIDED|95.0|0.738|1.384|||Log Rank|||This analysis included only subjects with DM only in a comparison of sibutramine and placebo.||1.384|0.738|0.948
72563153|NCT00442546|144658156|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.07|STANDARD_ERROR_OF_MEAN|0.093||0.4526||95.0|-0.254|0.114|||ANOVA||Mean difference (final values) = Least squares mean difference|96 hours||0.114|-0.254|0.4526
72563154|NCT00442546|144658156|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.045|STANDARD_ERROR_OF_MEAN|0.089||0.6186||95.0|-0.221|0.132|||ANOVA||Mean difference (final values) = Least squares mean difference|96 hours||0.132|-0.221|0.6186
72563155|NCT00442546|144658156|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.018|STANDARD_ERROR_OF_MEAN|0.109||0.8712||95.0|-0.237|0.202|||ANOVA||Mean difference (final values) = Least squares mean difference|120 hours||0.202|-0.237|0.8712
72563156|NCT00442546|144658156|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.078|STANDARD_ERROR_OF_MEAN|0.11||0.4784||95.0|-0.3|0.143|||ANOVA||Mean difference (final values) = Least squares mean difference|120 hours||0.143|-0.300|0.4784
72563157|NCT00442546|144658156|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.084|STANDARD_ERROR_OF_MEAN|0.075||0.2635||95.0|-0.232|0.064|||ANOVA||Mean difference (final values) = Least squares mean difference|Discharge||0.064|-0.232|0.2635
72563158|NCT00442546|144658156|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.039|STANDARD_ERROR_OF_MEAN|0.075||0.6009||95.0|-0.187|0.108|||ANOVA||Mean difference (final values) = Least squares mean difference|Discharge||0.108|-0.187|0.6009
72563159|NCT00442546|144658156|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.013|STANDARD_ERROR_OF_MEAN|0.073||0.8559||95.0|-0.13|0.156|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2||0.156|-0.130|0.8559
72563160|NCT00442546|144658156|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.001|STANDARD_ERROR_OF_MEAN|0.074||0.9841||95.0|-0.147|0.144|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2||0.144|-0.147|0.9841
72563161|NCT00442546|144658156|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.025|STANDARD_ERROR_OF_MEAN|0.061||0.6771||95.0|-0.095|0.146|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4||0.146|-0.095|0.6771
72563162|NCT00442546|144658156|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.056|STANDARD_ERROR_OF_MEAN|0.062||0.3717||95.0|-0.067|0.178|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4||0.178|-0.067|0.3717
72563163|NCT00442546|144658156|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.001|STANDARD_ERROR_OF_MEAN|0.058||0.9863||95.0|-0.114|0.116|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET||0.116|-0.114|0.9863
72459226|NCT00234832|144441092|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.276||||0.149|TWO_SIDED|95.0|0.916|1.776|||Log Rank|||This analysis included only subjects with CV only in a comparison of sibutramine and placebo.||1.776|0.916|0.149
72459227|NCT00234832|144441092|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.182||||0.022|TWO_SIDED|95.0|1.024|1.365|||Log Rank|||This analysis included only subjects with CV + DM in a comparison of sibutramine and placebo.||1.365|1.024|0.022
72459228|NCT00234832|144441093|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.043||||0.543|TWO_SIDED|95.0|0.91|1.196|||Log Rank|||||1.196|0.910|0.543
72459229|NCT00234832|144441094|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.097||||0.051|TWO_SIDED|95.0|0.999|1.204|||Log Rank|||||1.204|0.999|0.051
72459230|NCT00234832|144441095|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.276||||0.022|TWO_SIDED|95.0|1.036|1.571|||Log Rank|||||1.571|1.036|0.022
72459231|NCT00234832|144441096|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.355||||0.025|TWO_SIDED|95.0|1.038|1.767|||Log Rank|||||1.767|1.038|0.025
72459232|NCT00234832|144441097|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.582||||0.343|TWO_SIDED|95.0|0.613|4.081|||Log Rank|||||4.081|0.613|0.343
72459233|NCT00234832|144441098|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.988||||0.899|TWO_SIDED|95.0|0.822|1.188|||Log Rank|||||1.188|0.822|0.899
72500972|NCT01381094|144532139|SUPERIORITY||||||=|0.0656|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).||||=0.0656
72500973|NCT01381094|144532139|SUPERIORITY||||||=|0.6495|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).||||=0.6495
72500974|NCT01381094|144532140|SUPERIORITY||||||=|0.2065|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group.||||=0.2065
72500975|NCT01381094|144532140|SUPERIORITY||||||=|0.1807|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group.||||=0.1807
72500976|NCT01381094|144532140|SUPERIORITY||||||=|0.7869|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group.||||=0.7869
72500977|NCT01381094|144532140|SUPERIORITY||||||=|0.4743|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group.||||=0.4743
72500978|NCT01381094|144532140|SUPERIORITY||||||=|0.6407|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group.||||=0.6407
72500979|NCT01381094|144532141|SUPERIORITY||||||<|0.0001|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group.||||<0.0001
72500980|NCT01381094|144532141|SUPERIORITY||||||=|0.0002|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group.||||=0.0002
72500981|NCT01381094|144532141|SUPERIORITY||||||<|0.0001|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group.||||<0.0001
72500982|NCT01381094|144532141|SUPERIORITY||||||<|0.0001|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group.||||<0.0001
72500983|NCT01381094|144532141|SUPERIORITY||||||<|0.0001|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group.||||<0.0001
72500984|NCT01381094|144532142|SUPERIORITY||||||=|0.0002|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group.||||=0.0002
72500985|NCT01381094|144532142|SUPERIORITY||||||=|0.0004|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group.||||=0.0004
72500986|NCT01381094|144532142|SUPERIORITY||||||=|0.0002|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group.||||=0.0002
72500987|NCT01381094|144532142|SUPERIORITY||||||<|0.0001|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group.||||<0.0001
72563164|NCT00442546|144658156|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.126|STANDARD_ERROR_OF_MEAN|0.059||0.0355||95.0|0.009|0.243|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET||0.243|0.009|0.0355
72563165|NCT00442546|144658157|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.049|STANDARD_ERROR_OF_MEAN|0.202||0.8071||95.0|-0.35|0.449|||ANOVA||Mean difference (final values) = Least squares mean difference|24 hours||0.449|-0.350|0.8071
72563166|NCT00442546|144658157|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.044|STANDARD_ERROR_OF_MEAN|0.204||0.8282||95.0|-0.359|0.447|||ANOVA||Mean difference (final values) = Least squares mean difference|24 hours||0.447|-0.359|0.8282
72500988|NCT01381094|144532142|SUPERIORITY||||||=|0.0002|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group.||||=0.0002
72500989|NCT01381094|144532143|SUPERIORITY||||||<|0.0001|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group.||||<0.0001
72500990|NCT01381094|144532143|SUPERIORITY||||||=|0.0043|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group.||||=0.0043
72500991|NCT01381094|144532143|SUPERIORITY||||||<|0.0001|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group.||||<0.0001
72500992|NCT01381094|144532143|SUPERIORITY||||||<|0.0001|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group.||||<0.0001
72500993|NCT01381094|144532143|SUPERIORITY||||||=|0.0001|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group.||||=0.0001
72500994|NCT01381094|144532144|SUPERIORITY||||||=|0.0027|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group.||||=0.0027
72500995|NCT01381094|144532144|SUPERIORITY||||||<|0.0001|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group.||||<0.0001
72500996|NCT01381094|144532144|SUPERIORITY||||||=|0.0001|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group.||||=0.0001
72500997|NCT01381094|144532144|SUPERIORITY||||||<|0.0001|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group.||||<0.0001
72500998|NCT01381094|144532144|SUPERIORITY||||||=|0.0005|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group.||||=0.0005
72500999|NCT01381094|144532150|SUPERIORITY||||||=|0.6051|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 2).||||=0.6051
72501000|NCT01381094|144532150|SUPERIORITY||||||=|0.5197|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 2).||||=0.5197
72501001|NCT01381094|144532150|SUPERIORITY||||||=|0.1073|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 2).||||=0.1073
72501002|NCT01381094|144532150|SUPERIORITY||||||=|0.1321|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 2).||||=0.1321
72501003|NCT01381094|144532150|SUPERIORITY||||||=|0.4358|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 2).||||=0.4358
72501004|NCT01381094|144532150|SUPERIORITY||||||=|0.8109|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 4).||||=0.8109
72501005|NCT01381094|144532150|SUPERIORITY||||||=|0.2575|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 4).||||=0.2575
72501006|NCT01381094|144532150|SUPERIORITY||||||=|0.8361|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 4).||||=0.8361
72501007|NCT01381094|144532150|SUPERIORITY||||||=|0.0294|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 4).||||=0.0294
72563167|NCT00442546|144658157|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.025|STANDARD_ERROR_OF_MEAN|0.192||0.8972||95.0|-0.353|0.403|||ANOVA||Mean difference (final values) = Least squares mean difference|48 hours||0.403|-0.353|0.8972
72563168|NCT00442546|144658157|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.044|STANDARD_ERROR_OF_MEAN|0.19||0.8159||95.0|-0.329|0.418|||ANOVA||Mean difference (final values) = Least squares mean difference|48 hours||0.418|-0.329|0.8159
72563169|NCT00442546|144658157|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.034|STANDARD_ERROR_OF_MEAN|0.188||0.8577||95.0|-0.337|0.405|||ANOVA||Mean difference (final values) = Least squares mean difference|72 hours||0.405|-0.337|0.8577
72459234|NCT01799993|144441198|SUPERIORITY||Odds Ratio (OR)|0.841||||0.4263|TWO_SIDED|95.0|0.554|1.277|||Cochran-Mantel-Haenszel|||||1.277|0.554|0.4263
72459235|NCT01799993|144441199|SUPERIORITY|||||||0.6421|||||||Chi-squared|||||||0.6421
72501008|NCT01381094|144532150|SUPERIORITY||||||=|0.8809|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 4).||||=0.8809
72501009|NCT01381094|144532150|SUPERIORITY||||||=|0.4971|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 6).||||=0.4971
72501010|NCT01381094|144532150|SUPERIORITY||||||=|0.3994|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 6).||||=0.3994
72501011|NCT01381094|144532150|SUPERIORITY||||||=|0.5022|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 6).||||=0.5022
72501012|NCT01381094|144532150|SUPERIORITY||||||=|0.9916|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 6).||||=0.9916
72501013|NCT01381094|144532150|SUPERIORITY||||||=|0.2292|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 6).||||=0.2292
72501014|NCT01381094|144532150|SUPERIORITY||||||=|0.1331|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).||||=0.1331
72501015|NCT01381094|144532150|SUPERIORITY||||||=|0.5518|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).||||=0.5518
72563170|NCT00442546|144658157|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.044|STANDARD_ERROR_OF_MEAN|0.188||0.8158||95.0|-0.415|0.327|||ANOVA||Mean difference (final values) = Least squares mean difference|72 hours||0.327|-0.415|0.8158
72620931|NCT00452400|144772837|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.203|STANDARD_ERROR_OF_MEAN|0.03|<|0.0001||95.0|0.144|0.262|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 10 mcg qd minus Placebo|||0.262|0.144|<0.0001
72459236|NCT01799993|144441200|SUPERIORITY|||||||0.7984|||||||Chi-squared|||||||0.7984
72501016|NCT01381094|144532150|SUPERIORITY||||||=|0.9032|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).||||=0.9032
72501017|NCT01381094|144532150|SUPERIORITY||||||=|0.2387|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).||||=0.2387
72501018|NCT01381094|144532150|SUPERIORITY||||||=|0.4251|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).||||=0.4251
72501019|NCT01381094|144532151|SUPERIORITY||||||=|0.0448|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 2).||||=0.0448
72501020|NCT01381094|144532151|SUPERIORITY||||||=|0.0004|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 2).||||=0.0004
72563171|NCT00442546|144658157|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.156|STANDARD_ERROR_OF_MEAN|0.195||0.4243||95.0|-0.229|0.541|||ANOVA||Mean difference (final values) = Least squares mean difference|96 hours||0.541|-0.229|0.4243
72563172|NCT00442546|144658157|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.205|STANDARD_ERROR_OF_MEAN|0.187||0.2742||95.0|-0.164|0.574|||ANOVA||Mean difference (final values) = Least squares mean difference|96 hours||0.574|-0.164|0.2742
72459237|NCT01799993|144441201|SUPERIORITY|||||||0.7144|||||||ANOVA|||||||0.7144
72459238|NCT01799993|144441202|SUPERIORITY|||||||0.4278|||||||ANOVA|||||||0.4278
72459239|NCT04332991|144441232|SUPERIORITY||Odds Ratio (OR)|1.02|||||TWO_SIDED|95.0|0.73|1.42|||||Odds ratios greater than 1.0 indicated more favorable outcomes for patients in the hydroxychloroquine group compared with the placebo group.|Outcome measure was adjusted for age, sex, baseline COVID Outcome Scale category, baseline Sequential Organ Failure Assessment score, and duration of acute respiratory infection symptoms prior to randomization.||1.42|0.73|
72459240|NCT04332991|144441233|SUPERIORITY||Odds Ratio (OR)|1.28|||||TWO_SIDED|95.0|0.9|1.81|||||Odds ratios greater than 1.0 indicated more favorable outcomes for patients in the hydroxychloroquine group compared with the placebo group|Outcome measure was adjusted for: age, sex, baseline COVID Outcome Scale category, baseline Sequential Organ Failure Assessment score, and duration of acute respiratory infection symptoms prior to randomization||1.81|0.90|
72620932|NCT00452400|144772837|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.204|STANDARD_ERROR_OF_MEAN|0.03|<|0.0001||95.0|0.145|0.264|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 20 mcg qd minus Placebo|||0.264|0.145|<0.0001
72392491|NCT01652703|144292425|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-68.61|STANDARD_ERROR_OF_MEAN|2.99|<|0.001|TWO_SIDED|95.0|-74.51|-62.71||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factor of screening LDL-C level.|Placebo is the reference|The null hypothesis was that there was no mean difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.||-62.71|-74.51|<0.001
72459241|NCT04332991|144441234|SUPERIORITY||Odds Ratio (OR)|1.16|||||TWO_SIDED|95.0|0.84|1.61|||||Odds ratios greater than 1.0 indicated more favorable outcomes for patients in the hydroxychloroquine group compared with the placebo group|Outcome measure was adjusted for: age, sex, baseline COVID Outcome Scale category, baseline Sequential Organ Failure Assessment score, and duration of acute respiratory infection symptoms prior to randomization||1.61|0.84|
72459242|NCT04332991|144441235|SUPERIORITY||Odds Ratio (OR)|0.97|||||TWO_SIDED|95.0|0.69|1.38|||||Odds ratios greater than 1.0 indicated more favorable outcomes for patients in the hydroxychloroquine group compared with the placebo group|Outcome measure is adjusted for : age, sex, baseline COVID Outcome Scale category, baseline Sequential Organ Failure Assessment score, and duration of acute respiratory infection symptoms prior to randomization.||1.38|0.69|
72459243|NCT04332991|144441236|SUPERIORITY||Odds Ratio (OR)|1.56|||||TWO_SIDED|95.0|0.68|3.57|||||Odds ratios greater than 1.0 indicated less favorable outcomes for patients in the hydroxychloroquine group compared with the placebo group|||3.57|0.68|
72459244|NCT04332991|144441237|SUPERIORITY||Odds Ratio (OR)|1.07|||||TWO_SIDED|95.0|0.54|2.09|||||Odds ratios greater than 1.0 indicated less favorable outcomes for patients in the hydroxychloroquine group compared with the placebo group|||2.09|0.54|
72459245|NCT04332991|144441238|SUPERIORITY||Odds Ratio (OR)|1.13|||||TWO_SIDED|95.0|0.6|2.14|||||Odds ratios greater than 1.0 indicated less favorable outcomes for patients in the hydroxychloroquine group compared with the placebo group|Outcome measure was adjusted for: age, sex, baseline COVID Outcome Scale category, baseline Sequential Organ Failure Assessment score, and duration of acute respiratory infection symptoms prior to randomization||2.14|0.60|
72459246|NCT04332991|144441239|SUPERIORITY||Odds Ratio (OR)|0.96|||||TWO_SIDED|95.0|0.68|1.34|||||Odds ratios greater than 1.0 indicated more favorable outcomes for patients in the hydroxychloroquine group compared with the placebo group|Outcome measure was adjusted for age, sex, baseline COVID Outcome Scale category, baseline Sequential Organ Failure Assessment score, and duration of acute respiratory infection symptoms prior to randomization||1.34|0.68|
72459247|NCT04332991|144441240|SUPERIORITY||Odds Ratio (OR)|1.26|||||TWO_SIDED|95.0|0.76|2.08|||||Odds ratios greater than 1.0 indicated more favorable outcomes for patients in the hydroxychloroquine group compared with the placebo group|Outcome measure was adjusted for: age, sex, baseline COVID Outcome Scale category, baseline Sequential Organ Failure Assessment score, and duration of acute respiratory infection symptoms prior to randomization||2.08|0.76|
72459248|NCT04332991|144441241|SUPERIORITY||Odds Ratio (OR)|1.03|||||TWO_SIDED|95.0|0.61|1.72|||||Odds ratios greater than 1.0 indicated more favorable outcomes for patients in the hydroxychloroquine group compared with the placebo group|Outcome measure was adjusted for: age, sex, baseline COVID Outcome Scale category, baseline Sequential Organ Failure Assessment score, and duration of acute respiratory infection symptoms prior to randomization||1.72|0.61|
72459249|NCT04332991|144441242|SUPERIORITY||Odds Ratio (OR)|1.26|||||TWO_SIDED|95.0|0.84|1.88|||||Odds ratios greater than 1.0 indicated more favorable outcomes for patients in the hydroxychloroquine group compared with the placebo group|Outcome measure was adjusted for: age, sex, baseline COVID Outcome Scale category, baseline Sequential Organ Failure Assessment score, and duration of acute respiratory infection symptoms prior to randomization||1.88|0.84|
72501021|NCT01381094|144532151|SUPERIORITY||||||=|0.0813|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 2).||||=0.0813
72501022|NCT01381094|144532151|SUPERIORITY||||||=|0.0038|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 2).||||=0.0038
72459250|NCT04332991|144441243|SUPERIORITY||Odds Ratio (OR)|1.17|||||TWO_SIDED|95.0|0.85|1.61|||||Odds ratios greater than 1.0 indicated more favorable outcomes for patients in the hydroxychloroquine group compared with the placebo group|Outcome measure was adjusted for: age, sex, baseline COVID Outcome Scale category, baseline Sequential Organ Failure Assessment score, and duration of acute respiratory infection symptoms prior to randomization||1.61|0.85|
72501023|NCT01381094|144532151|SUPERIORITY||||||=|0.6861|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 2).||||=0.6861
72459251|NCT04332991|144441244|SUPERIORITY||Risk Difference (RD)|0.4|||||TWO_SIDED|95.0|-1.0|1.8||||||||1.8|-1.0|
72459252|NCT04332991|144441245|SUPERIORITY||Odds Ratio (OR)|1.36|||||TWO_SIDED|95.0|0.61|3.02|||||Odds ratios greater than 1.0 indicated less favorable outcomes for patients in the hydroxychloroquine group compared with the placebo group|||3.02|0.61|
72459253|NCT04332991|144441246|SUPERIORITY||Odds Ratio (OR)|0.81|||||TWO_SIDED|95.0|0.24|2.7|||||Odds ratios greater than 1.0 indicated less favorable outcomes for patients in the hydroxychloroquine group compared with the placebo group|||2.70|0.24|
72459254|NCT04332991|144441247|SUPERIORITY||Odds Ratio (OR)|2.51|||||TWO_SIDED|95.0|0.78|8.12|||||Odds ratios greater than 1.0 indicated less favorable outcomes for patients in the hydroxychloroquine group compared with the placebo group|||8.12|0.78|
72459255|NCT04332991|144441248|SUPERIORITY||Odds Ratio (OR)|0.69|||||TWO_SIDED|95.0|0.45|1.05|||||Odds ratios greater than 1.0 indicated less favorable outcomes for patients in the hydroxychloroquine group compared with the placebo group|||1.05|0.45|
72459256|NCT04332991|144441249|SUPERIORITY||Odds Ratio (OR)|0.81|||||TWO_SIDED|95.0|0.24|2.7|||||Odds ratios greater than 1.0 indicated less favorable outcomes for patients in the hydroxychloroquine group compared with the placebo group|||2.70|0.24|
72459257|NCT04332991|144441250|SUPERIORITY||Odds Ratio (OR)|0.97|||||TWO_SIDED|95.0|0.59|1.59|||||Odds ratios greater than 1.0 indicated less favorable outcomes for patients in the hydroxychloroquine group compared with the placebo group|||1.59|0.59|
72459258|NCT04332991|144441251|SUPERIORITY||Odds Ratio (OR)|0.69|||||TWO_SIDED|95.0|0.3|1.58|||||Odds ratios greater than 1.0 indicated less favorable outcomes for patients in the hydroxychloroquine group compared with the placebo group|||1.58|0.30|
72459259|NCT04332991|144441252|SUPERIORITY||Odds Ratio (OR)|1.23|||||TWO_SIDED|95.0|0.48|3.18|||||Odds ratios greater than 1.0 indicated less favorable outcomes for patients in the hydroxychloroquine group compared with the placebo group|||3.18|0.48|
72459260|NCT04332991|144441253|SUPERIORITY||Odds Ratio (OR)|0.98|||||TWO_SIDED|95.0|0.24|3.96|||||Odds ratios greater than 1.0 indicated less favorable outcomes for patients in the hydroxychloroquine group compared with the placebo group|||3.96|0.24|
72459261|NCT04332991|144441254|SUPERIORITY||Odds Ratio (OR)|1.06|||||TWO_SIDED|95.0|0.73|1.53|||||Odds ratios greater than 1.0 indicated less favorable outcomes for patients in the hydroxychloroquine group compared with the placebo group|||1.53|0.73|
72459262|NCT04332991|144441255|SUPERIORITY||Odds Ratio (OR)|1.32|||||TWO_SIDED|95.0|0.92|1.89|||||Odds ratios greater than 1.0 indicated less favorable outcomes for patients in the hydroxychloroquine group compared with the placebo group|||1.89|0.92|
72459263|NCT04332991|144441256|SUPERIORITY||Odds Ratio (OR)|0.78|||||TWO_SIDED|95.0|0.21|2.94|||||Odds ratios greater than 1.0 indicated less favorable outcomes for patients in the hydroxychloroquine group compared with the placebo group|||2.94|0.21|
72459264|NCT04332991|144441257|SUPERIORITY||Odds Ratio (OR)|0.98|||||TWO_SIDED|95.0|0.06|15.74|||||Odds ratios greater than 1.0 indicated less favorable outcomes for patients in the hydroxychloroquine group compared with the placebo group|||15.74|0.06|
72459265|NCT04332991|144441258|SUPERIORITY||Odds Ratio (OR)|0.97|||||TWO_SIDED|95.0|0.69|1.35|||||Odds ratios greater than 1.0 indicated less favorable outcomes for patients in the hydroxychloroquine group compared with the placebo group|Outcome measure was adjusted for: age, sex, baseline COVID Outcome Scale category, baseline Sequential Organ Failure Assessment score, and duration of acute respiratory infection symptoms prior to randomization||1.35|0.69|
72459266|NCT01129011|144441266|SUPERIORITY_OR_OTHER||proportions|11.9||||0.001|TWO_SIDED|95.0|7.9|17.1|||Cochran-Mantel-Haenszel|CMH test stratified by use of low-dose aspirin (Yes/No) at randomization.||The primary efficacy endpoint was the proportion of subjetcs developing gastric ulcers throughout 6 months of study treatment. A summary, including cumulative frequency and percentage with associated 95% confidence intervals was produced for the observational incidences of gastric ulcers at 6 months. The cumulative proportion of subjects developing gastric ulcers at 6 months was analyzed using the CMH test stratified by use of low-dose aspirin (Yes/No) at randomization.||17.1|7.9|0.001
72459267|NCT01129011|144441267|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||Cochran-Mantel-Haenszel|||||||0.001
72459268|NCT01129011|144441268|SUPERIORITY_OR_OTHER|||||||0.009||95.0|||||Cochran-Mantel-Haenszel|||||||0.009
72459269|NCT01129011|144441269|SUPERIORITY_OR_OTHER|||||||0.007||95.0|||||Cochran-Mantel-Haenszel|||||||0.007
72459270|NCT01129011|144441270|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||Cochran-Mantel-Haenszel|||||||0.001
72459271|NCT03745651|144441308|SUPERIORITY||Odds Ratio (OR)|8.84|||<|0.0001|TWO_SIDED|95.0|4.125|21.202||The unadjusted p-values between each treatment group and vehicle were calculated based on Exact Logistic Regression including treatment and stratification factors to test the treatment difference.|Exact Logistic Regression|||||21.202|4.125|< 0.0001
72459272|NCT03745651|144441308|SUPERIORITY||Odds Ratio (OR)|15.8|||<|0.0001|TWO_SIDED|95.0|7.354|38.061||The unadjusted p-values between each treatment group and vehicle were calculated based on Exact Logistic Regression including treatment and stratification factors to test the treatment difference.|Exact Logistic Regression|||||38.061|7.354|< 0.0001
72501024|NCT01381094|144532151|SUPERIORITY||||||=|0.0553|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 4).||||=0.0553
72501025|NCT01381094|144532151|SUPERIORITY||||||=|0.0004|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 4).||||=0.0004
72459273|NCT03745651|144441309|SUPERIORITY||Odds Ratio (OR)|6.84|||<|0.0001|TWO_SIDED|95.0|3.723|13.184||The unadjusted p-values between each treatment group and vehicle were calculated based on Exact Logistic Regression including treatment and stratification factors to test the treatment difference.|Exact Logistic Regression|||||13.184|3.723|< 0.0001
72459274|NCT03745651|144441309|SUPERIORITY||Odds Ratio (OR)|10.67|||<|0.0001|TWO_SIDED|95.0|5.775|20.732||The unadjusted p-values between each treatment group and vehicle were calculated based on Exact Logistic Regression including treatment and stratification factors to test the treatment difference.|Exact Logistic Regression|||||20.732|5.775|< 0.0001
72459275|NCT03745651|144441310|SUPERIORITY||Odds Ratio (OR)|4.17|||<|0.0001|TWO_SIDED|95.0|2.045|9.036||The unadjusted p-values between each treatment group and vehicle were calculated based on Exact Logistic Regression including treatment and stratification factors to test the treatment difference.|Exact Logistic Regression|||||9.036|2.045|< 0.0001
72459276|NCT03745651|144441310|SUPERIORITY||Odds Ratio (OR)|5.8|||<|0.0001|TWO_SIDED|95.0|2.833|12.657||The unadjusted p-values between each treatment group and vehicle were calculated based on Exact Logistic Regression including treatment and stratification factors to test the treatment difference.|Exact Logistic Regression|||||12.657|2.833|< 0.0001
72459277|NCT03745651|144441311|SUPERIORITY||Odds Ratio (OR)|1.11||||0.8553|TWO_SIDED|95.0|0.598|2.094||The unadjusted p-values between each treatment group and vehicle were calculated based on Exact Logistic Regression including treatment and stratification factors to test the treatment difference.|Exact Logistic Regression|||||2.094|0.598|0.8553
72459278|NCT03745651|144441311|SUPERIORITY||Odds Ratio (OR)|1.47||||0.2359|TWO_SIDED|95.0|0.805|2.741||The unadjusted p-values between each treatment group and vehicle were calculated based on Exact Logistic Regression including treatment and stratification factors to test the treatment difference.|Exact Logistic Regression|||||2.741|0.805|0.2359
72459279|NCT03745651|144441312|SUPERIORITY||Odds Ratio (OR)|1.62||||0.1784|TWO_SIDED|95.0|0.827|3.342||The unadjusted p-values between each treatment group and vehicle were calculated based on Exact Logistic Regression including treatment and stratification factors to test the treatment difference.|Exact Logistic Regression|||||3.342|0.827|0.1784
72501026|NCT01381094|144532151|SUPERIORITY||||||<|0.0001|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 4).||||<0.0001
72501027|NCT01381094|144532151|SUPERIORITY||||||<|0.0001|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 4).||||<0.0001
72459280|NCT03745651|144441312|SUPERIORITY||Odds Ratio (OR)|1.96||||0.0472|TWO_SIDED|95.0|1.007|4.0||The unadjusted p-values between each treatment group and vehicle were calculated based on Exact Logistic Regression including treatment and stratification factors to test the treatment difference.|Exact Logistic Regression|||||4.000|1.007|0.0472
72459281|NCT03745651|144441322|SUPERIORITY||Least Squares Mean Difference|-31.91|STANDARD_ERROR_OF_MEAN|4.92|<|0.0001|TWO_SIDED|95.0|-41.57|-22.25|||Mixed-Model with Repeated Measures|The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.||Percent change from Baseline in EASI score at Week 2||-22.25|-41.57|<0.0001
72459282|NCT03745651|144441322|SUPERIORITY||Least Squares Mean Difference|-35.13|STANDARD_ERROR_OF_MEAN|4.93|<|0.0001|TWO_SIDED|95.0|-44.81|-25.44|||Mixed-Model with Repeated Measures|The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.||Percent change from Baseline in EASI score at Week 2||-25.44|-44.81|<0.0001
72459283|NCT03745651|144441322|SUPERIORITY||Least Squares Mean Difference|-44.56|STANDARD_ERROR_OF_MEAN|4.4|<|0.0001|TWO_SIDED|95.0|-53.19|-35.92|||Mixed-Model with Repeated Measures|The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.||Percent change from Baseline in EASI score at Week 4||-35.92|-53.19|<0.0001
72459284|NCT03745651|144441322|SUPERIORITY||Least Squares Mean Difference|-45.91|STANDARD_ERROR_OF_MEAN|4.4|<|0.0001|TWO_SIDED|95.0|-54.55|-37.26|||Mixed-Model with Repeated Measures|The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.||Percent change from Baseline in EASI score at Week 4||-37.26|-54.55|<0.0001
72459285|NCT03745651|144441322|SUPERIORITY||Least Squares Mean Difference|-44.53|STANDARD_ERROR_OF_MEAN|4.35|<|0.0001|TWO_SIDED|95.0|-53.08|-35.98|||Mixed-Model with Repeated Measures|The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.||Percent change from Baseline in EASI score at Week 8||-35.98|-53.08|<0.0001
72459286|NCT03745651|144441322|SUPERIORITY||Least Squares Mean Difference|-46.0|STANDARD_ERROR_OF_MEAN|4.33|<|0.0001|TWO_SIDED|95.0|-54.51|-37.48|||Mixed-Model with Repeated Measures|The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.||Percent change from Baseline in EASI score at Week 8||-37.48|-54.51|<0.0001
72459287|NCT03745651|144441323|SUPERIORITY||Least Squares Mean Difference|-39.4|STANDARD_ERROR_OF_MEAN|3.59|<|0.0001|TWO_SIDED|95.0|-46.48|-32.38|||ANCOVA|P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable.||Percent change from Baseline in SCORAD score at Week 8||-32.38|-46.48|<0.0001
72459288|NCT03745651|144441323|SUPERIORITY||Least Squares Mean Difference|-43.5|STANDARD_ERROR_OF_MEAN|3.56|<|0.0001|TWO_SIDED|95.0|-50.51|-36.53|||ANCOVA|P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable.||Percent change from Baseline in SCORAD score at Week 8||-36.53|-50.51|<0.0001
72459289|NCT03745651|144441324|SUPERIORITY||Least Squares Mean Difference|-1.52|STANDARD_ERROR_OF_MEAN|0.26|<|0.0001|TWO_SIDED|95.0|-2.02|-1.01|||Mixed-Model with Repeated Measures|The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.||Change from Baseline in Itch NRS score at Week 2||-1.01|-2.02|<0.0001
72459290|NCT03745651|144441324|SUPERIORITY||Least Squares Mean Difference|-1.74|STANDARD_ERROR_OF_MEAN|0.26|<|0.0001|TWO_SIDED|95.0|-2.24|-1.24|||Mixed-Model with Repeated Measures|The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.||Change from Baseline in Itch NRS score at Week 2||-1.24|-2.24|<0.0001
72459291|NCT03745651|144441324|SUPERIORITY||Least Squares Mean Difference|-1.79|STANDARD_ERROR_OF_MEAN|0.29|<|0.0001|TWO_SIDED|95.0|-2.36|-1.23|||Mixed-Model with Repeated Measures|The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.||Change from Baseline in Itch NRS score at Week 4||-1.23|-2.36|<0.0001
72501028|NCT01381094|144532151|SUPERIORITY||||||=|0.7379|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 4).||||=0.7379
72459292|NCT03745651|144441324|SUPERIORITY||Least Squares Mean Difference|-1.97|STANDARD_ERROR_OF_MEAN|0.29|<|0.0001|TWO_SIDED|95.0|-2.53|-1.4|||Mixed-Model with Repeated Measures|The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.||Change from Baseline in Itch NRS score at Week 4||-1.40|-2.53|<0.0001
72459293|NCT03745651|144441324|SUPERIORITY||Least Squares Mean Difference|-1.89|STANDARD_ERROR_OF_MEAN|0.31|<|0.0001|TWO_SIDED|95.0|-2.49|-1.29|||Mixed-Model with Repeated Measures|The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.||Change from Baseline in Itch NRS score at Week 8||-1.29|-2.49|<0.0001
72459294|NCT03745651|144441324|SUPERIORITY||Least Squares Mean Difference|-1.7|STANDARD_ERROR_OF_MEAN|0.3|<|0.0001|TWO_SIDED|95.0|-2.3|-1.1|||Mixed-Model with Repeated Measures|The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.||Change from Baseline in Itch NRS score at Week 8||-1.10|-2.30|<0.0001
72501029|NCT01381094|144532151|SUPERIORITY||||||=|0.072|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 6).||||=0.0720
72459295|NCT03745651|144441326|SUPERIORITY||Least Squares Mean Difference|-1.5|STANDARD_ERROR_OF_MEAN|0.25|<|0.0001|TWO_SIDED|95.0|-1.94|-0.97|||ANCOVA|P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable.||Change from Baseline in Skin Pain NRS score at Week 8||-0.97|-1.94|<0.0001
72459296|NCT03745651|144441326|SUPERIORITY||Least Squares Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|0.25|<|0.0001|TWO_SIDED|95.0|-1.72|-0.76|||ANCOVA|P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable.||Change from Baseline in Skin Pain NRS score at Week 8||-0.76|-1.72|<0.0001
72459297|NCT03745651|144441329|SUPERIORITY||Least Squares Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.57||0.2903|TWO_SIDED|95.0|-1.71|0.51|||Mixed-Model with Repeated Measures|The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.||Change from Baseline in PROMIS Short Form-Sleep Disturbance (8b) 24-hour recall score at Week 2||0.51|-1.71|0.2903
72459298|NCT03745651|144441329|SUPERIORITY||Least Squares Mean Difference|-0.98|STANDARD_ERROR_OF_MEAN|0.57||0.0837|TWO_SIDED|95.0|-2.09|0.13|||Mixed-Model with Repeated Measures|The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.||Change from Baseline in PROMIS Short Form-Sleep Disturbance (8b) 24-hour recall score at Week 2||0.13|-2.09|0.0837
72459299|NCT03745651|144441329|SUPERIORITY||Least Squares Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.61||0.6272|TWO_SIDED|95.0|-1.5|0.91|||Mixed-Model with Repeated Measures|The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.||Change from Baseline in PROMIS Short Form-Sleep Disturbance (8b) 24-hour recall score at Week 4||0.91|-1.50|0.6272
72459300|NCT03745651|144441329|SUPERIORITY||Least Squares Mean Difference|-0.86|STANDARD_ERROR_OF_MEAN|0.61||0.1609|TWO_SIDED|95.0|-2.07|0.34|||Mixed-Model with Repeated Measures|The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.||Change from Baseline in PROMIS Short Form-Sleep Disturbance (8b) 24-hour recall score at Week 4||0.34|-2.07|0.1609
72459301|NCT03745651|144441329|SUPERIORITY||Least Squares Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.73||0.3362|TWO_SIDED|95.0|-2.13|0.73|||Mixed-Model with Repeated Measures|The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.||Change from Baseline in PROMIS Short Form-Sleep Disturbance (8b) 24-hour recall score at Week 8||0.73|-2.13|0.3362
72459302|NCT03745651|144441329|SUPERIORITY||Least Squares Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.73||0.269|TWO_SIDED|95.0|-2.23|0.62|||Mixed-Model with Repeated Measures|The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.||Change from Baseline in PROMIS Short Form-Sleep Disturbance (8b) 24-hour recall score at Week 8||0.62|-2.23|0.2690
72459303|NCT03745651|144441330|SUPERIORITY||Least Squares Mean Difference|-1.07|STANDARD_ERROR_OF_MEAN|0.54||0.0482|TWO_SIDED|95.0|-2.13|-0.01|||Mixed-Model with Repeated Measures|The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.||Change from Baseline in PROMIS Short Form - Sleep-Related Impairment (8a) 24-hour recall score at Week 2||-0.01|-2.13|0.0482
72459304|NCT03745651|144441330|SUPERIORITY||Least Squares Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|0.54||0.0271|TWO_SIDED|95.0|-2.26|-0.14|||Mixed-Model with Repeated Measures|The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.||Change from Baseline in PROMIS Short Form - Sleep-Related Impairment (8a) 24-hour recall score at Week 2||-0.14|-2.26|0.0271
72459305|NCT03745651|144441330|SUPERIORITY||Least Squares Mean Difference|-0.76|STANDARD_ERROR_OF_MEAN|0.6||0.2091|TWO_SIDED|95.0|-1.94|0.42|||Mixed-Model with Repeated Measures|The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.||Change from Baseline in PROMIS Short Form - Sleep-Related Impairment (8a) 24-hour recall score at Week 4||0.42|-1.94|0.2091
72459306|NCT03745651|144441330|SUPERIORITY||Least Squares Mean Difference|-1.53|STANDARD_ERROR_OF_MEAN|0.6||0.0111|TWO_SIDED|95.0|-2.71|-0.35|||Mixed-Model with Repeated Measures|The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.||Change from Baseline in PROMIS Short Form - Sleep-Related Impairment (8a) 24-hour recall score at Week 4||-0.35|-2.71|0.0111
72563173|NCT00442546|144658157|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.069|STANDARD_ERROR_OF_MEAN|0.116||0.5569||95.0|-0.302|0.165|||ANOVA||Mean difference (final values) = Least squares mean difference|120 hours||0.165|-0.302|0.5569
72459307|NCT03745651|144441330|SUPERIORITY||Least Squares Mean Difference|-1.18|STANDARD_ERROR_OF_MEAN|0.68||0.0802|TWO_SIDED|95.0|-2.51|0.14|||Mixed-Model with Repeated Measures|The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.||Change from Baseline in PROMIS Short Form - Sleep-Related Impairment (8a) 24-hour recall score at Week 8||0.14|-2.51|0.0802
72459308|NCT03745651|144441330|SUPERIORITY||Least Squares Mean Difference|-1.24|STANDARD_ERROR_OF_MEAN|0.67||0.0666|TWO_SIDED|95.0|-2.56|0.09|||Mixed-Model with Repeated Measures|The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.||Change from Baseline in PROMIS Short Form - Sleep-Related Impairment (8a) 24-hour recall score at Week 8||0.09|-2.56|0.0666
72459309|NCT03745651|144441333|SUPERIORITY||Least Squares Mean Difference|-3.9|STANDARD_ERROR_OF_MEAN|0.48|<|0.0001|TWO_SIDED|95.0|-4.84|-2.97|||ANCOVA|P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable.||Change from Baseline in %BSA at Week 8||-2.97|-4.84|<0.0001
72459310|NCT03745651|144441333|SUPERIORITY||Least Squares Mean Difference|-4.5|STANDARD_ERROR_OF_MEAN|0.47|<|0.0001|TWO_SIDED|95.0|-5.47|-3.63|||ANCOVA|P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable.||Change from Baseline in %BSA at Week 8||-3.63|-5.47|<0.0001
72459311|NCT03745651|144441335|SUPERIORITY||Least Squares Mean Difference|-6.1|STANDARD_ERROR_OF_MEAN|0.64|<|0.0001|TWO_SIDED|95.0|-7.38|-4.86|||ANCOVA|P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable.||Change from Baseline in POEM score at Week 8||-4.86|-7.38|<0.0001
72459312|NCT03745651|144441335|SUPERIORITY||Least Squares Mean Difference|-5.9|STANDARD_ERROR_OF_MEAN|0.64|<|0.0001|TWO_SIDED|95.0|-7.17|-4.67|||ANCOVA|P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable.||Change from Baseline in POEM score at Week 8||-4.67|-7.17|<0.0001
72563174|NCT00442546|144658157|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.103|STANDARD_ERROR_OF_MEAN|0.116||0.3762||95.0|-0.13|0.336|||ANOVA||Mean difference (final values) = Least squares mean difference|120 hours||0.336|-0.130|0.3762
72563175|NCT00442546|144658157|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.077|STANDARD_ERROR_OF_MEAN|0.155||0.6203||95.0|-0.229|0.383|||ANOVA||Mean difference (final values) = Least squares mean difference|Discharge||0.383|-0.229|0.6203
72459313|NCT03745651|144441337|SUPERIORITY||Least Squares Mean Difference|-3.3|STANDARD_ERROR_OF_MEAN|0.48|<|0.0001|TWO_SIDED|95.0|-4.19|-2.32|||ANCOVA|P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable.||Change from Baseline in total DLQI score at Week 8||-2.32|-4.19|<0.0001
72459314|NCT03745651|144441337|SUPERIORITY||Least Squares Mean Difference|-2.8|STANDARD_ERROR_OF_MEAN|0.47|<|0.0001|TWO_SIDED|95.0|-3.67|-1.83|||ANCOVA|P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable.||Change from Baseline in total DLQI score at Week 8||-1.83|-3.67|<0.0001
72459315|NCT03745651|144441339|SUPERIORITY||Least Squares Mean Difference|-4.1|STANDARD_ERROR_OF_MEAN|1.55||0.0099|TWO_SIDED|95.0|-7.24|-1.03|||ANCOVA|P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable.||Change from Baseline in total CDLQI score at Week 8||-1.03|-7.24|0.0099
72459316|NCT03745651|144441339|SUPERIORITY||Least Squares Mean Difference|-3.1|STANDARD_ERROR_OF_MEAN|1.59||0.0542|TWO_SIDED|95.0|-6.3|0.06|||ANCOVA|P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable.||Change from Baseline in total CDLQI score at Week 8||0.06|-6.30|0.0542
72459317|NCT03745651|144441343|SUPERIORITY||Odds Ratio (OR)|5.16|||<|0.0001|TWO_SIDED|95.0|2.987|9.049||The unadjusted p-values between each treatment group and vehicle were calculated based on Exact Logistic Regression including treatment and stratification factors to test the treatment difference.|Exact Logistic Regression|||Percentage of participants with a score of either 1 or 2 on the PGIC at Week 8||9.049|2.987|<0.0001
72459318|NCT03745651|144441343|SUPERIORITY||Odds Ratio (OR)|7.47|||<|0.0001|TWO_SIDED|95.0|4.23|13.415||The unadjusted p-values between each treatment group and vehicle were calculated based on Exact Logistic Regression including treatment and stratification factors to test the treatment difference.|Exact Logistic Regression|||Percentage of participants with a score of either 1 or 2 on the PGIC at Week 8||13.415|4.230|<0.0001
72459319|NCT03745651|144441344|SUPERIORITY||Least Squares Mean Difference|4.4|STANDARD_ERROR_OF_MEAN|1.78||0.015|TWO_SIDED|95.0|0.85|7.86|||ANCOVA|P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable.||Change from Baseline in EQ VAS score at Week 8||7.86|0.85|0.0150
72459320|NCT03745651|144441344|SUPERIORITY||Least Squares Mean Difference|5.1|STANDARD_ERROR_OF_MEAN|1.77||0.0044|TWO_SIDED|95.0|1.59|8.54|||ANCOVA|P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable.||Change from Baseline in EQ VAS score at Week 8||8.54|1.59|0.0044
72459321|NCT03745651|144441345|SUPERIORITY||Least Squares Mean Difference|-5.6|STANDARD_ERROR_OF_MEAN|3.81||0.142|TWO_SIDED|95.0|-13.12|1.89|||ANCOVA|P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable.||Percent work time missed due to AD: Change from Baseline in WPAI-SHP v2.0 at Week 8||1.89|-13.12|0.1420
72459322|NCT03745651|144441345|SUPERIORITY||Least Squares Mean Difference|-8.0|STANDARD_ERROR_OF_MEAN|3.82||0.0375|TWO_SIDED|95.0|-15.51|-0.47|||ANCOVA|P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable.||Percent work time missed due to AD: Change from Baseline in WPAI-SHP v2.0 at Week 8||-0.47|-15.51|0.0375
72459323|NCT03745651|144441345|SUPERIORITY||Least Squares Mean Difference|-9.1|STANDARD_ERROR_OF_MEAN|2.75||0.0012|TWO_SIDED|95.0|-14.48|-3.63|||ANCOVA|P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable.||Percent impairment while working due to AD: Change from Baseline in WPAI-SHP v2.0 at Week 8||-3.63|-14.48|0.0012
72459324|NCT03745651|144441345|SUPERIORITY||Least Squares Mean Difference|-7.2|STANDARD_ERROR_OF_MEAN|2.74||0.0095|TWO_SIDED|95.0|-12.58|-1.77|||ANCOVA|P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable.||Percent impairment while working due to AD: Change from Baseline in WPAI-SHP v2.0 at Week 8||-1.77|-12.58|0.0095
72459325|NCT03745651|144441345|SUPERIORITY||Least Squares Mean Difference|-15.2|STANDARD_ERROR_OF_MEAN|3.8|<|0.0001|TWO_SIDED|95.0|-22.69|-7.73|||ANCOVA|P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable.||Percent overall work impairment due to AD: Change from Baseline in WPAI-SHP v2.0 at Week 8||-7.73|-22.69|<0.0001
72459326|NCT03745651|144441345|SUPERIORITY||Least Squares Mean Difference|-12.6|STANDARD_ERROR_OF_MEAN|3.79||0.001|TWO_SIDED|95.0|-20.1|-5.18|||ANCOVA|P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable.||Percent overall work impairment due to AD: Change from Baseline in WPAI-SHP v2.0 at Week 8||-5.18|-20.10|0.0010
72459327|NCT03745651|144441345|SUPERIORITY||Least Squares Mean Difference|-12.1|STANDARD_ERROR_OF_MEAN|2.09|<|0.0001|TWO_SIDED|95.0|-16.18|-7.95|||ANCOVA|P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable.||Percent activity impairment due to AD: Change from Baseline in WPAI-SHP v2.0 at Week 8||-7.95|-16.18|<0.0001
72459328|NCT03745651|144441345|SUPERIORITY||Least Squares Mean Difference|-10.4|STANDARD_ERROR_OF_MEAN|2.08|<|0.0001|TWO_SIDED|95.0|-14.53|-6.37|||ANCOVA|P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable.||Percent activity impairment due to AD: Change from Baseline in WPAI-SHP v2.0 at Week 8||-6.37|-14.53|<0.0001
72459329|NCT01494467|144441349|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
72459330|NCT01494467|144441350|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-8.22|||<|0.001|TWO_SIDED|95.0|-10.18|-6.25|||ANCOVA|||||-6.25|-10.18|<0.001
72459331|NCT01494467|144441351|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
72459332|NCT04739306|144441366|EQUIVALENCE|Predefined equivalence margin: -3 letters to +3 letters|Estimated difference in LS means|0.58|||||TWO_SIDED|90.0|-0.52|1.67|||ANCOVA|Analysis conducted for study eye. Primary endpoint as the dependent variable, treatment as a factor, baseline BCVA and country as covariates.||||1.67|-0.52|
72459333|NCT01077284|144441371|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Hochberg's method for multiple comparisons was used to ensure that the overall 0.050 level of significance was maintained for comparisons of febuxostat to allopurinol and to placebo.|Wilcoxon (Mann-Whitney)|||||||<0.001
72459334|NCT01077284|144441371|SUPERIORITY_OR_OTHER|||||||0.003||95.0||||Hochberg's method for multiple comparisons was used to ensure that the overall 0.050 level of significance was maintained for comparisons of febuxostat to allopurinol and to placebo.|Wilcoxon (Mann-Whitney)|||||||0.003
72459335|NCT01077284|144441372|SUPERIORITY_OR_OTHER|||||||0.13||||||Hochberg's method for multiple comparisons was used to ensure that the overall 0.050 level of significance was maintained for comparisons of febuxostat to allopurinol and to placebo.|Wilcoxon (Mann-Whitney)|||||||0.130
72459336|NCT01077284|144441372|SUPERIORITY_OR_OTHER|||||||0.348||||||Hochberg's method for multiple comparisons was used to ensure that the overall 0.050 level of significance was maintained for comparisons of febuxostat to allopurinol and to placebo.|Wilcoxon (Mann-Whitney)|||||||0.348
72563176|NCT00442546|144658157|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.15|STANDARD_ERROR_OF_MEAN|0.155||0.3343||95.0|-0.155|0.455|||ANOVA||Mean difference (final values) = Least squares mean difference|Discharge||0.455|-0.155|0.3343
72563177|NCT00442546|144658157|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.157|STANDARD_ERROR_OF_MEAN|0.128||0.2213||95.0|-0.096|0.41|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2||0.410|-0.096|0.2213
72563178|NCT00442546|144658157|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.14|STANDARD_ERROR_OF_MEAN|0.131||0.2863||95.0|-0.118|0.399|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2||0.399|-0.118|0.2863
72563179|NCT00442546|144658157|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.084|STANDARD_ERROR_OF_MEAN|0.082||0.305||95.0|-0.077|0.245|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4||0.245|-0.077|0.3050
72563180|NCT00442546|144658157|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.204|STANDARD_ERROR_OF_MEAN|0.083||0.0155||95.0|0.039|0.368|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4||0.368|0.039|0.0155
72620933|NCT00452400|144772838|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.155|STANDARD_ERROR_OF_MEAN|0.027|<|0.0001||95.0|0.101|0.209|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 2 mcg qd minus Placebo|||0.209|0.101|<0.0001
72620934|NCT00452400|144772838|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.185|STANDARD_ERROR_OF_MEAN|0.027|<|0.0001||95.0|0.131|0.239|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 5 mcg qd minus Placebo|||0.239|0.131|<0.0001
72459337|NCT01077284|144441373|SUPERIORITY_OR_OTHER|||||||0.403||||||Hochberg's method for multiple comparisons was used to ensure that the overall 0.050 level of significance was maintained for comparisons of febuxostat to allopurinol and to placebo.|Wilcoxon (Mann-Whitney)|||||||0.403
72459338|NCT01077284|144441373|SUPERIORITY_OR_OTHER|||||||0.413||||||Hochberg's method for multiple comparisons was used to ensure that the overall 0.050 level of significance was maintained for comparisons of febuxostat to allopurinol and to placebo.|Wilcoxon (Mann-Whitney)|||||||0.413
72459339|NCT01077284|144441374|SUPERIORITY_OR_OTHER|||||||0.5535||||||Hochberg's method for multiple comparisons was used to ensure that the overall 0.050 level of significance was maintained for comparisons of febuxostat to allopurinol and to placebo.|ANOVA|P-values are from ANOVA with treatment as a fixed effect.||||||0.5535
72459340|NCT01077284|144441374|SUPERIORITY_OR_OTHER|||||||0.94||||||Hochberg's method for multiple comparisons was used to ensure that the overall 0.050 level of significance was maintained for comparisons of febuxostat to allopurinol and to placebo.|ANOVA|P-values are from ANOVA with treatment as a fixed effect.||||||0.9400
72459341|NCT00237718|144441375|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||ANCOVA|||||||>0.05
72459342|NCT00237718|144441376|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||ANCOVA|||||||>0.05
72459343|NCT02432183|144441393|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0061|||||||Kruskal-Wallis|post-hoc comparison with Dunn's multiple comparison test: p=0.0326 between arm 1 and 2; p=0.0147 between arm 1 and 3||||||0.0061
72459344|NCT01133678|144441415|OTHER|||||||0.19||||||A recommendation to stop the trial early was stipulated if the conditional power at the interim analysis (after 50 patients) was \<10% using a stochastic curtailment approach.. This would occur if the interim test statistic is t \< -0.287.|t-test, 2 sided|t-statistic = -1.330, exceeding threshold (\<-0.287, conditional power\<10%) for early termination.||||||0.190
72459345|NCT02077374|144441421|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-17.0||||0.0195|TWO_SIDED|95.0|-30.7|-2.5|||Wilcoxon (Mann-Whitney)||Based on Hodges-Lehmann estimator|Statistical Analysis for the difference in mean change in alanine aminotransferase (ALT) from Baseline to Day28/ET between IDN-6556 and placebo||-2.5|-30.7|0.0195
72459346|NCT02077374|144441423|SUPERIORITY_OR_OTHER||Median Difference (Net)|-0.8||||0.8724|TWO_SIDED|95.0|-14.5|11.2|||Wilcoxon (Mann-Whitney)||Based on Hodges-Lehmann estimator|Statistical Analysis for the difference in change in aspartate aminotransferase (AST) from baseline to Day 28/ET between IDN-6556 and placebo||11.2|-14.5|0.8724
72459347|NCT02077374|144441424|SUPERIORITY_OR_OTHER||Median Difference (Net)|-145.0||||0.1149|TWO_SIDED|95.0|-336.0|55.0|||Wilcoxon (Mann-Whitney)||Based on Hodges-Lehmann estimator|Statistical Analysis for the difference in change for cCK18/M30 from Baseline to Day 28/ET between IDN-6556 and Placebo||55|-336|0.1149
72459348|NCT02077374|144441425|SUPERIORITY_OR_OTHER||Median Difference (Net)|-250.0||||0.1365|TWO_SIDED|95.0|-590.0|63.0|||Wilcoxon (Mann-Whitney)||Based on Hodges-Lehmann estimator|Statistical Analysis for the difference in change for caspase 3/7 from Baseline to Day 28/ET between IDN-6556 and Placebo||63|-590|0.1365
72459349|NCT02077374|144441426|SUPERIORITY_OR_OTHER||Median Difference (Net)|-327.0||||0.0471|TWO_SIDED|95.0|-628.0|-7.0|||Wilcoxon (Mann-Whitney)||Based on Hodges-Lehmann estimator|Statistical Analysis of the difference in the change in full-length cytokeratine 18 (flCK18/M65) from Baseline to Day 28/ET between IDN-6556 and placebo||-7|-628|0.0471
72563181|NCT00442546|144658157|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.008|STANDARD_ERROR_OF_MEAN|0.087||0.9243||95.0|-0.164|0.181|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET||0.181|-0.164|0.9243
72563182|NCT00442546|144658157|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.21|STANDARD_ERROR_OF_MEAN|0.089||0.0201||95.0|0.033|0.386|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET||0.386|0.033|0.0201
72563183|NCT00442546|144658158|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.46|STANDARD_ERROR_OF_MEAN|0.321||0.1537||95.0|-1.093|0.173|||ANOVA||Mean difference (final values) = Least squares mean difference|Discharge||0.173|-1.093|0.1537
72620935|NCT00452400|144772838|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.231|STANDARD_ERROR_OF_MEAN|0.027|<|0.0001||95.0|0.178|0.284|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 10 mcg qd minus Placebo|||0.284|0.178|<0.0001
72620936|NCT00452400|144772838|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.231|STANDARD_ERROR_OF_MEAN|0.028|<|0.0001||95.0|0.177|0.286|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 20 mcg qd minus Placebo|||0.286|0.177|<0.0001
72459350|NCT00424476|144441433|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.83||||0.0006||95.0|1.3|2.59||For the primary analysis of the primary efficacy endpoint, a step-down sequential testing procedure was used to control the type 1 error.|Regression, Logistic|Adjusted for baseline stratification factors (SELENA SLEDAI Score: ≤9 vs ≥10; proteinuria: \<2g vs ≥2g per 24hr; Race: African/indig-American vs Other)||||2.59|1.30|0.0006
72459351|NCT00424476|144441433|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.55||||0.0129|TWO_SIDED|95.0|1.1|2.19||After superiority of 10 mg/kg vs placebo was established, the 1 mg/kg group was tested vs placebo (2-sided alpha=0.05).|Regression, Logistic|Adjusted for baseline stratification factors.||||2.19|1.10|0.0129
72459352|NCT00424476|144441434|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.71||||0.0024|TWO_SIDED|95.0|1.21|2.41|||Regression, Logistic|Adjusted for baseline stratification factors.||||2.41|1.21|0.0024
72459353|NCT00424476|144441434|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.51||||0.0189|TWO_SIDED|95.0|1.07|2.14|||Regression, Logistic|Adjusted for baseline stratification factors.||||2.14|1.07|0.0189
72459354|NCT00424476|144441435|SUPERIORITY_OR_OTHER|||||||0.0003||95.0|||||ANCOVA|Adjusted for baseline PGA score and baseline stratification factors.||||||0.0003
72459355|NCT00424476|144441435|SUPERIORITY_OR_OTHER|||||||0.2712||95.0|||||ANCOVA|Adjusted for baseline PGA score and baseline stratification factors.||||||0.2712
72459356|NCT00424476|144441436|SUPERIORITY_OR_OTHER|||||||0.887|||||||ANCOVA|Adjusted for the baseline PCS score and baseline stratification factors.||||||0.8870
72459357|NCT00424476|144441436|SUPERIORITY_OR_OTHER|||||||0.8127|||||||ANCOVA|Adjusted for the baseline PCS score and baseline stratification factors.||||||0.8127
72370508|NCT00488683|144251632|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|-0.05||||0.81||95.0|||||Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one month after booster vaccination for the serogroup Y||||0.81
72459358|NCT00424476|144441437|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.75||||0.0526|TWO_SIDED|95.0|0.99|3.08|||Regression, Logistic|Adjusted for baseline prednisone dose level and baseline stratification factors.||||3.08|0.99|0.0526
72459359|NCT00424476|144441437|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.89||||0.0252|TWO_SIDED|95.0|1.08|3.31|||Regression, Logistic|Adjusted for baseline prednisone dose level and baseline stratification factors.||||3.31|1.08|0.0252
72459360|NCT00657709|144441439|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the hSBA GMT at one month following third vaccination was within this equivalence interval for each of the two co-primary comparisons, rMenB Lot1 and rMenB Lot2 would be equivalent for 44/76-SL strain with respect to the immune response to the vaccine lot.|hSBA GMT ratios|0.9|||||TWO_SIDED|95.0|0.81|0.99|||ANOVA|95% CIs for the GMTs ratios was obtained by exponentiating difference of least square means of log-transformed titers and both the limits of 95% CIs.||The study would be considered a success if the two-sided 95% confidence intervals (CIs) for the hSBA GMT ratios comparing rMenB Lot1 to rMenB Lot2 for 44/76-SL strain at one month after the third vaccination was contained within the equivalence interval (0.5, 2.0).||0.99|0.81|
72459361|NCT00657709|144441439|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the hSBA GMT at one month following third vaccination was within this equivalence interval for each of the two co-primary comparisons, rMenB Lot1 and rMenB Lot3 would be equivalent for 44/76-SL strain with respect to the immune response to the vaccine lot.|hSBA GMT ratios|1.02|||||TWO_SIDED|95.0|0.93|1.13|||ANOVA|95% CIs for the GMTs ratios was obtained by exponentiating difference of least square means of log-transformed titers and both the limits of 95% CIs.||The study would be considered a success if the two-sided 95% confidence intervals (CIs) for the hSBA GMT ratios comparing rMenB Lot1 to rMenB Lot3 for 44/76-SL strain at one month after the third vaccination was contained within the equivalence interval (0.5, 2.0).||1.13|0.93|
72459362|NCT00657709|144441439|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the hSBA GMT at one month following third vaccination was within this equivalence interval for each of the two co-primary comparisons, rMenB Lot2 and rMenB Lot3 would be equivalent for 44/76-SL strain with respect to the immune response to the vaccine lot.|hSBA GMT ratios|1.14|||||TWO_SIDED|95.0|1.03|1.27|||ANOVA|95% CIs for the GMTs ratios was obtained by exponentiating difference of least square means of log-transformed titers and both the limits of 95% CIs.||The study would be considered a success if the two-sided 95% confidence intervals (CIs) for the hSBA GMT ratios comparing rMenB Lot2 to rMenB Lot3 for 44/76-SL strain at one month after the third vaccination was contained within the equivalence interval (0.5, 2.0).||1.27|1.03|
72470075|NCT01124838|144464407|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference|-0.49||||0.842|TWO_SIDED|95.0|-5.32|4.34|||ANOVA|From ANOVA of change from baseline to final/early termination visit with treatment and race (Japanese vs. non-Japanese) as factors.||The statistical test for the ranked secondary variables was carried out in hierarchical order at the significance level of 5%.||4.34|-5.32|0.842
72470076|NCT04297618|144464408|OTHER||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||||||<0.01
72470077|NCT04297618|144464409|OTHER||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||||||<0.01
72470078|NCT02726945|144464426|SUPERIORITY|||||||0.023|||||||Wilcoxon (Mann-Whitney)|||"Data from the groups showed a strong non-normal distribution, thus non-parametric methods were used with a Bonferroni correction for multiple comparison .~Statistical significance was defined as either of the treatment groups to be superior to the placebo group."||||0.023
72470079|NCT02726945|144464426|SUPERIORITY|||||||0.043|||||||Wilcoxon (Mann-Whitney)|||"Data from the groups showed a strong non-normal distribution, thus non-parametric methods were used with a Bonferroni correction for multiple comparison .~Statistical significance was defined as either of the treatment groups to be superior to the placebo group."||||0.043
72470080|NCT02783573|144464433|SUPERIORITY||LS Mean Difference (Final Values)|2.51|STANDARD_ERROR_OF_MEAN|1.64||0.129|TWO_SIDED|95.0|-0.752|5.776|||Mixed Models Analysis|||||5.776|-0.752|0.129
72470081|NCT02783573|144464433|SUPERIORITY||LS Mean Difference (Final Values)|-0.21|STANDARD_ERROR_OF_MEAN|1.76||0.903|TWO_SIDED|95.0|-3.725|3.296|||Mixed Models Analysis|||||3.296|-3.725|0.903
72459363|NCT00657709|144441439|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the hSBA GMT at one month following third vaccination was within this equivalence interval for each of the two co-primary comparisons, rMenB Lot1 and rMenB Lot2 would be equivalent for 5/99 strain with respect to the immune response to the vaccine lot.|hSBA GMT ratios|0.88|||||TWO_SIDED|95.0|0.78|0.98|||ANOVA|95% CIs for the GMTs ratios was obtained by exponentiating difference of least square means of log-transformed titers and both the limits of 95% CIs.||The study would be considered a success if the two-sided 95% confidence intervals (CIs) for the hSBA GMT ratios comparing rMenB Lot1 to rMenB Lot2 for 5/99 strain at one month after the third vaccination was contained within the equivalence interval (0.5, 2.0).||0.98|0.78|
72459364|NCT00657709|144441439|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the hSBA GMT at one month following third vaccination was within this equivalence interval for each of the two co-primary comparisons, rMenB Lot1 and rMenB Lot3 would be equivalent for 5/99 strain with respect to the immune response to the vaccine lot.|hSBA GMT ratios|0.99|||||TWO_SIDED|95.0|0.88|1.1|||ANOVA|95% CIs for the GMTs ratios was obtained by exponentiating difference of least square means of log-transformed titers and both the limits of 95% CIs.||The study would be considered a success if the two-sided 95% confidence intervals (CIs) for the hSBA GMT ratios comparing rMenB Lot1 to rMenB Lot3 for 5/99 strain at one month after the third vaccination was contained within the equivalence interval (0.5, 2.0).||1.1|0.88|
72459365|NCT00657709|144441439|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the hSBA GMT at one month following third vaccination was within this equivalence interval for each of the two co-primary comparisons, rMenB Lot2 and rMenB Lot3 would be equivalent for 5/99 strain with respect to the immune response to the vaccine lot.|hSBA GMT ratios|1.12|||||TWO_SIDED|95.0|1.0|1.26|||ANOVA|95% CIs for the GMTs ratios was obtained by exponentiating difference of least square means of log-transformed titers and both the limits of 95% CIs||The study would be considered a success if the two-sided 95% confidence intervals (CIs) for the hSBA GMT ratios comparing rMenB Lot2 to rMenB Lot3 for 5/99 strain at one month after the third vaccination was contained within the equivalence interval (0.5, 2.0).||1.26|1.0|
72459366|NCT00657709|144441439|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the hSBA GMT at one month following third vaccination was within this equivalence interval for each of the two co-primary comparisons, rMenB Lot1 and rMenB Lot2 would be equivalent for for NZ98/254 strain with respect to the immune response to the vaccine lot.|hSBA GMT ratios|1.04||||||95.0|0.88|1.23|||ANOVA|95% CIs for the GMTs ratios was obtained by exponentiating difference of least square means of log-transformed titers and both the limits of 95% CIs.||The study would be considered a success if the two-sided 95% confidence intervals (CIs) for the hSBA GMT ratios comparing rMenB Lot1 to rMenB Lot2 for NZ98/254 strain at one month after the third vaccination was contained within the equivalence interval (0.5, 2.0).||1.23|0.88|
72459367|NCT00657709|144441439|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the hSBA GMT at one month following third vaccination was within this equivalence interval for each of the two co-primary comparisons, rMenB Lot1 and rMenB Lot3 would be equivalent for for NZ98/254 strain with respect to the immune response to the vaccine lot.|hSBA GMT ratios|0.96||||||95.0|0.81|1.13|||ANOVA|95% CIs for the GMTs ratios was obtained by exponentiating difference of least square means of log-transformed titers and both the limits of 95% CIs.||The study would be considered a success if the two-sided 95% confidence intervals (CIs) for the hSBA GMT ratios comparing rMenB Lot1 to rMenB Lot3 for NZ98/254 strain at one month after the third vaccination was contained within the equivalence interval (0.5, 2.0).||1.13|0.81|
72459368|NCT00657709|144441439|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the hSBA GMT at one month following third vaccination was within this equivalence interval for each of the two co-primary comparisons, rMenB Lot2 and rMenB Lot3 would be equivalent for for NZ98 /254 strain with respect to the immune response to the vaccine lot.|hSBA GMT ratios|0.92|||||TWO_SIDED|95.0|0.78|1.08|||ANOVA|95% CIs for the GMTs ratios was obtained by exponentiating difference of least square means of log-transformed titers and both the limits of 95% CIs.||"The study would be considered a success if the two-sided 95% confidence intervals (CIs) for the hSBA GMT ratios comparing rMenB Lot2 to rMenB Lot3 for NZ98~/254 strain at one month after the third vaccination was contained within the equivalence interval (0.5, 2.0)."||1.08|0.78|
72459369|NCT00657709|144441441|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (-10%, 10%). If the two sided 95% CIs of the differences in the percentages of subjects at one month following third vaccination was within this equivalence interval for each of the two comparisons, rMenB Lot1 and rMenB Lot2 would be equivalent for 44/76-SL strain.|Vaccines Group Differences|0.0|||||TWO_SIDED|95.0|-1.0|1.0|||Miettinen and Nurminen|The lot-to-lot differences in these percentages and associated 95% CIs were computed for each pair of rMenB+OMV lots.||The three vaccine lots would be considered equivalent if for each of the three strains and each pair of vaccine lots, the 95% CIs of the differences in the percentage of subjects with hSBA titers ≥ 1:5 at one month after the third vaccination, were entirely within the interval \[-10%, 10%\].||1|-1|
72459370|NCT00657709|144441441|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (-10%, 10%). If the two sided 95% CIs of the differences in the percentages of subjects at one month following third vaccination was within this equivalence interval for each of the two comparisons, rMenB Lot1 and rMenB Lot3 would be equivalent for 44/76-SL strain.|Vaccines Group Differences|1.0|||||TWO_SIDED|95.0|0.0|2.0|||Miettinen and Nurminen|The lot-to-lot differences in these percentages and associated 95% CIs were computed for each pair of rMenB+OMV lots.||The three vaccine lots would be considered equivalent if for each of the three strains and each pair of vaccine lots, the 95% CIs of the differences in the percentage of subjects with hSBA titers ≥ 1:5 at 1month after the third dose, were entirely within the interval \[-10%, 10%\].||2|0|
72470082|NCT02783573|144464434|SUPERIORITY||LS Mean Difference (Final Values)|-2.95|STANDARD_ERROR_OF_MEAN|1.78||0.1|TWO_SIDED|95.0|-6.488|0.58|||Mixed Models Analysis|||||0.580|-6.488|0.100
72470083|NCT02783573|144464434|SUPERIORITY||LS Mean Difference (Final Values)|-3.18|STANDARD_ERROR_OF_MEAN|1.86||0.092|TWO_SIDED|95.0|-6.876|0.525|||Mixed Models Analysis|||||0.525|-6.876|0.092
72470084|NCT02783573|144464435|SUPERIORITY||LS Mean Difference (Final Values)|1.23|STANDARD_ERROR_OF_MEAN|1.14||0.285|TWO_SIDED|95.0|-1.045|3.499|||Mixed Models Analysis|||||3.499|-1.045|0.285
72459371|NCT00657709|144441441|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (-10%, 10%). If the two sided 95% CIs of the differences in the percentages of subjects at one month following third vaccination was within this equivalence interval for each of the two comparisons, rMenB Lot2 and rMenB Lot3 would be equivalent for 44/76-SL strain.|Vaccines Group Differences|1.0|||||TWO_SIDED|95.0|0.0|2.0|||Miettinen and Nurminen|The lot-to-lot differences in these percentages and associated 95% CIs were computed for each pair of rMenB+OMV lots.||The three vaccine lots would be considered equivalent if for each of the three strains and each pair of vaccine lots, the 95% CIs of the differences in the percentage of subjects with hSBA titers ≥ 1:5 at 1month after the third dose, were entirely within the interval \[-10%, 10%\].||2|0|
72459372|NCT00657709|144441441|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (-10%, 10%). If the two sided 95% CIs of the differences in the percentages of subjects at one month following third vaccination was within this equivalence interval for each of the two comparisons, rMenB Lot1 and rMenB Lot2 would be equivalent for 5/99 strain.|Vaccines Group Differences|0.0|||||TWO_SIDED|95.0|-1.0|1.0|||Miettinen and Nurminen|The lot-to-lot differences in these percentages and associated 95% CIs were computed for each pair of rMenB+OMV lots.||The three vaccine lots would be considered equivalent if for each of the three strains and each pair of vaccine lots, the 95% CIs of the differences in the percentage of subjects with hSBA titers ≥ 1:5 at 1month after the third dose, were entirely within the interval \[-10%, 10%\].||1|-1|
72459373|NCT00657709|144441441|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (-10%, 10%). If the two sided 95% CIs of the differences in the percentages of subjects at one month following third vaccination was within this equivalence interval for each of the two comparisons, rMenB Lot1 and rMenB Lot3 would be equivalent for 5/99 strain.|Vaccines Group Differences|1.0|||||TWO_SIDED|95.0|0.0|2.0|||Miettinen and Nurminen|The lot-to-lot differences in these percentages and associated 95% CIs were computed for each pair of rMenB+OMV lots.||The three vaccine lots would be considered equivalent if for each of the three strains and each pair of vaccine lots, the 95% CIs of the differences in the percentage of subjects with hSBA titers ≥ 1:5 at 1month after the third dose, were entirely within the interval \[-10%, 10%\].||2|0|
72459374|NCT00657709|144441441|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (-10%, 10%). If the two sided 95% CIs of the differences in the percentages of subjects at one month following third vaccination was within this equivalence interval for each of the two comparisons, rMenB Lot2 and rMenB Lot3 would be equivalent for 5/99 strain.|Vaccines Group Differences|1.0|||||TWO_SIDED|95.0|0.0|2.0|||Miettinen and Nurminen|The lot-to-lot differences in these percentages and associated 95% CIs were computed for each pair of rMenB+OMV lots.||The three vaccine lots would be considered equivalent if for each of the three strains and each pair of vaccine lots, the 95% CIs of the differences in the percentage of subjects with hSBA titers ≥ 1:5 at 1month after the third dose, were entirely within the interval \[-10%, 10%\].||2|0|
72459375|NCT00657709|144441441|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (-10%, 10%). If the two sided 95% CIs of the differences in the percentages of subjects at one month following third vaccination was within this equivalence interval for each of the two comparisons, rMenB Lot1 and rMenB Lot2 would be equivalent for NZ98/254 strain.|Percentage group difference|3.0|||||TWO_SIDED|95.0|-2.0|8.0|||Miettinen and Nurminen|The lot-to-lot differences in these percentages and associated 95% CIs were computed for each pair of rMenB+OMV lots.||The three vaccine lots would be considered equivalent if for each of the three strains and each pair of vaccine lots, the 95% CIs of the differences in the percentages of subjects with hSBA titers ≥ 1:5 at 1 month after the third dose, were entirely within the interval \[-10%, 10%\].||8|-2|
72459376|NCT00657709|144441441|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (-10%, 10%). If the two sided 95% CIs of the differences in the percentages of subjects at one month following third vaccination was within this equivalence interval for each of the two comparisons, rMenB Lot1 and rMenB Lot3 would be equivalent for NZ 98/254 strain.|Percentage group difference|-1.0|||||TWO_SIDED|95.0|-6.0|4.0|||Miettinen and Nurminen|The lot-to-lot difference in these percentages and associated 95% CIs were computed for each pair of rMenB+OMV lots.||The three vaccine lots would be considered equivalent if for each of the three strains and each pair of vaccine lots, the 95% CIs of the differences in the percentage of subjects with hSBA titers ≥ 1:5 at 1 month after the third dise, were entirely within the interval \[-10%, 10%\].||4|-6|
72459377|NCT00657709|144441441|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (-10%, 10%). If the two sided (5% CIs of the differences in the percentages of subjects at one month following third vaccination was within this equivalence interval for each of the two comparisons, rMenB Lot2 and rMenB Lot3 would be equivalent for NZ98/254 strain.|Percentage group difference|-4.0|||||TWO_SIDED|95.0|-9.0|1.0|||Miettinen and Nurminen|The lot-to-lot differences in these percentages and associated 95% CIs were computed for each pair of rMenB+OMV lots.||The three vaccine lots would be considered equivalent if for each of the three strains and each pair of vaccine lots, the 95% CIs of the differences in the percentage of subjects with hSBA titers ≥ 1:5 at one month after the third dose, were entirely within the interval \[-10%, 10%\].||1|-9|
72459378|NCT00657709|144441444|NON_INFERIORITY_OR_EQUIVALENCE|GMCs (GMCrMenB+OMV NZ lot1+lot2+lot3+InfanrixHexa / GMCInfanrixHexa)|Geometric group difference|0.84|||||TWO_SIDED|95.0|0.76|0.94|||ANOVA|GMCs and 95% CIs were constructed by exponentiating (base 10) the least squares means of the log10-transformed titers and their associated 95% CIs.||Immunogenicity of the pertussis components (FHA) of DTPa-HBV-IPV when given concomitantly with rMenB and PCV7 would be considered non-inferior to that of routine vaccines given alone if the lower limit of the two-sided CI for the ratio of GMCs one month after the third vaccination is ≥0.67.||0.94|0.76|
72459379|NCT00657709|144441444|NON_INFERIORITY_OR_EQUIVALENCE|GMCs (GMCrMenB+OMV NZ lot1+lot2+lot3+InfanrixHexa / GMCInfanrixHexa)|Geometric group difference|0.77|||||TWO_SIDED|95.0|0.67|0.89|||ANOVA|GMCs and 95% CIs were constructed by exponentiating (base 10) the least square means of the log10-transformed titers and their associated 95% CIs.||Immunogenicity of the pertussis component (Pertactin) of DTPa-HBV-IPV when given concomitantly with rMenB and PCV7 would be considered non-inferior to that of the routine vaccines given alone if the lower limit of the two-sided CI for the ratio of GMCs one month after the third vaccination is ≥0.67.||0.89|0.67|
72470085|NCT02783573|144464435|SUPERIORITY||LS Mean Difference (Final Values)|-0.52|STANDARD_ERROR_OF_MEAN|1.19||0.661|TWO_SIDED|95.0|-2.889|1.843|||Mixed Models Analysis|||||1.843|-2.889|0.661
72470086|NCT02783573|144464436|SUPERIORITY||LS Mean Difference (Final Values)|-4.77|STANDARD_ERROR_OF_MEAN|2.69||0.079|TWO_SIDED|95.0|-10.103|0.56|||Mixed Models Analysis|||||0.56|-10.103|0.079
72459380|NCT00657709|144441444|NON_INFERIORITY_OR_EQUIVALENCE|GMCs (GMCrMenB+OMV NZ lot1+lot2+lot3+InfanrixHexa / GMCInfanrixHexa)|Geometric group difference|0.8|||||TWO_SIDED|95.0|0.71|0.91|||ANOVA|GMCs and 95% CIs were constructed by exponentiating (base 10) the least squares means of the log10-transformed titers and their associated 95% CIS.||Immunogenicity of the pertussis components (PT) of DTPa-HBV-IPV when given concomitantly with rMenB and PCV7 would be considered non-inferior to that of the routine vaccines given alone if the lower limit of the two-sided CI for the ratio of GMCs one month after the third vaccination is ≥0.67.||0.91|0.71|
72459381|NCT00657709|144441445|NON_INFERIORITY_OR_EQUIVALENCE|{PConcomitant Vaccine +rMenB+OMV NZ lot1+lot2+lot3 minus PConcomitant Vaccine}|Percentage group difference|0.0|||||TWO_SIDED|95.0|-1.0|2.0|||Miettinen and Nurminen|||Immunogenicity of the routine infant vaccines, when given concomitantly with rMenB+OMV NZ at 2, 4, and 6 months of age,would be considered non-inferior to that of routine infant vaccines given alone, for diphtheria toxoids antigen, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response greater than or equal to the cut-off level ≥0.1 IU/mL for that antigen.||2|-1|
72459382|NCT00657709|144441445|NON_INFERIORITY_OR_EQUIVALENCE|{PConcomitant Vaccine +rMenB+OMV NZ lot1+lot2+lot3 minus PConcomitant Vaccine}|Percentage group difference|-5.0|||||TWO_SIDED|95.0|-12.0|1.0|||Miettinen and Nurminen|||Immunogenicity of the routine infant vaccines, when given concomitantly with rMenB+OMV NZ at 2, 4, and 6 months of age, would be considered non-inferior to that of routine infant vaccines given alone, for diphtheria toxoids antigen, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response greater than or equal to the cut-off level ≥1.0 IU/mL for that antigen.||1|-12|
72459383|NCT00657709|144441445|NON_INFERIORITY_OR_EQUIVALENCE|{PConcomitant Vaccine +rMenB+OMV NZ lot1+lot2+lot3 minus PConcomitant Vaccine}|Percentage group difference|0.0|||||TWO_SIDED|95.0|-2.0|2.0|||Miettinen and Nurminen|||Immunogenicity of the routine infant vaccines, when given concomitantly with rMenB+OMV NZ at 2, 4, and 6 months of age, would be considered non-inferior to that of routine infant vaccines given alone, for Tetanus toxoids antigen, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response greater than or equal to the cut-off level ≥0.1 IU/mL for that antigen.||2|-2|
72459384|NCT00657709|144441445|NON_INFERIORITY_OR_EQUIVALENCE|{PConcomitant Vaccine +rMenB+OMV NZ lot1+lot2+lot3 minus PConcomitant Vaccine}|Percentage group difference|-4.0|||||TWO_SIDED|95.0|-9.0|1.0|||Miettinen and Nurminen|||Immunogenicity of the routine infant vaccines, when given concomitantly with rMenB+OMV NZ at 2, 4, and 6 months of age, would be considered non-inferior to that of routine infant vaccines given alone, for Tetanus toxoids antigen, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response greater than or equal to the cut-off level ≥1.0 IU/mL for that antigen.||1|-9|
72459385|NCT00657709|144441445|NON_INFERIORITY_OR_EQUIVALENCE|{PConcomitant Vaccine +rMenB+OMV NZ lot1+lot2+lot3 minus PConcomitant Vaccine}|Percentage group difference|-1.0|||||TWO_SIDED|95.0|-5.0|2.0|||Miettinen and Nurminen|||Immunogenicity of the polio type 1 of Diphtheria-Tetanus-Acellular Pertussis, Hepatitis B, Inactivated Poliovirus and Haemophilus influenzae type b (DTPa-HBV-IPV) when given concomitantly with rMenB and Pneumococcal 7-valent conjugate vaccine (PCV7) at 2, 4, and 6 months of age would be considered non-inferior to that of the confidence interval for the difference in the percentage of subjects with NT titers ≥1:8 was greater than -10%.||2|-5|
72563184|NCT00442546|144658158|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.398|STANDARD_ERROR_OF_MEAN|0.324||0.2208||95.0|-1.038|0.241|||ANOVA||Mean difference (final values) = Least squares mean difference|Discharge||0.241|-1.038|0.2208
72370509|NCT00488683|144251632|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|0.28||||0.07||95.0|||||Parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Pearson correlation coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one month after booster vaccination for the serogroup Y||||0.07
72459386|NCT00657709|144441445|NON_INFERIORITY_OR_EQUIVALENCE|{PConcomitant Vaccine +rMenB+OMV NZ lot1+lot2+lot3 minus PConcomitant Vaccine}|vaccine group difference|-5.0|||||TWO_SIDED|95.0|-11.0|-1.0|||Miettinen and Nurminen|||Immunogenicity of the polio type 2 of Diphtheria-Tetanus-Acellular Pertussis, Hepatitis B, Inactivated Poliovirus and Haemophilus influenzae type b (DTPa-HBVIPV) when given concomitantly with rMenB and Pneumococcal 7-valent conjugate vaccine (PCV7) at 2, 4, and 6 months of age would be considered non-inferior to that of the confidence interval for the difference in the percentage of subjects with NT titers ≥1:8 was greater than -10%.||-1|-11|
72459387|NCT00657709|144441445|NON_INFERIORITY_OR_EQUIVALENCE|{PConcomitant Vaccine +rMenB+OMV NZ lot1+lot2+lot3 minus PConcomitant Vaccine}|Percentage group difference|-1.0|||||TWO_SIDED|95.0|-4.0|2.0|||Miettinen and Nurminen|||Immunogenicity of the polio type 3 of DTPa-HBV-IPV when given concomitantly with rMenB and PCV7 at 2,4, and 6 months of age would be considered non-inferior to that of the routine vaccinations given alone, if the lower limit of the two sided 95% confidence interval for the difference in the percentage of subjects with NT titers ≥1:8 was greater than -10%.||2|-4|
72563185|NCT00442546|144658158|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.068|STANDARD_ERROR_OF_MEAN|0.325||0.8355||95.0|-0.707|0.572|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2||0.572|-0.707|0.8355
72563186|NCT00442546|144658158|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.222|STANDARD_ERROR_OF_MEAN|0.331||0.5024||95.0|-0.875|0.43|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2||0.430|-0.875|0.5024
72563187|NCT00442546|144658158|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.067|STANDARD_ERROR_OF_MEAN|0.282||0.8116||95.0|-0.489|0.624|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4||0.624|-0.489|0.8116
72563188|NCT00442546|144658158|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.099|STANDARD_ERROR_OF_MEAN|0.288||0.7325||95.0|-0.667|0.469|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4||0.469|-0.667|0.7325
72563189|NCT00442546|144658158|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.066|STANDARD_ERROR_OF_MEAN|0.278||0.8133||95.0|-0.614|0.482|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET||0.482|-0.614|0.8133
72563190|NCT00442546|144658158|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.025|STANDARD_ERROR_OF_MEAN|0.285||0.9307||95.0|-0.588|0.538|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET||0.538|-0.588|0.9307
72370510|NCT00488683|144251632|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.36||||0.02||95.0|||||Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one month after booster vaccination for the serogroup A||||0.02
72459388|NCT00657709|144441445|NON_INFERIORITY_OR_EQUIVALENCE|{PConcomitant Vaccine +rMenB+OMV NZ lot1+lot2+lot3 minus PConcomitant Vaccine}|percentage group difference|-2.0|||||TWO_SIDED|95.0|-5.0|-1.0|||Miettinen and Nurminen|||Immunogenicity of the hepatitis B surface antigen component of DTPa-HBV-IPV when given concomitantly with rMenB and PCV7 vaccine at 2, 4, and 6 months of age would be considered non-inferior to that of the routine vaccinations given alone, if the lower limit of the two sided 95% confidence interval for the difference in the percentage of subjects with NT ≥10.0 mIU/ml was greater than -10%||-1|-5|
72459389|NCT00657709|144441445|NON_INFERIORITY_OR_EQUIVALENCE|{PConcomitant Vaccine +rMenB+OMV NZ lot1+lot2+lot3 minus PConcomitant Vaccine}|percentage group difference|-1.0|||||TWO_SIDED|95.0|-3.0|1.0|||Miettinen and Nurminen|||Immunogenicity of the PRP-Hib component of DTPa-HBV-IPV when given concomitantly with rMenB and PCV7 vaccine at 2, 4, and 6 months of age would be considered non-inferiority that of the routine vaccinations given alone, if the lower limit of the two sided 95% confidence interval for the difference in the percentage of subjects with Hib capsular polysaccharide (PRP) antibody response greater than the protective cutoff of ≥0.15 μg/mL was greater than -10%.||1|-3|
72459390|NCT00657709|144441445|NON_INFERIORITY_OR_EQUIVALENCE|{PConcomitant Vaccine +rMenB+OMV NZ lot1+lot2+lot3 minus PConcomitant Vaccine}|vaccine group difference|0.0|||||TWO_SIDED|95.0|-7.0|7.0|||Miettinen and Nurminen|||Immunogenicity of the PRP-Hib component of DTPa-HBV-IPV when given concomitantly with rMenB and PCV7 vaccine at 2, 4, and 6 months of age would be considered non-inferior to that of the routine vaccinations given alone, if the lower limit of the two sided 95% confidence interval for the difference in the percentage of subjects with Hib capsular polysaccharide (PRP) antibody response greater than the protective cutoff of ≥1.0 μg/mL was greater than -10%.||7|-7|
72470087|NCT02783573|144464436|SUPERIORITY||LS Mean Difference (Final Values)|-1.97|STANDARD_ERROR_OF_MEAN|2.82||0.486|TWO_SIDED|95.0|-7.573|3.62|||Mixed Models Analysis|||||3.62|-7.573|0.486
72470088|NCT02783573|144464437|SUPERIORITY||LS Mean Difference (Final Values)|0.25|STANDARD_ERROR_OF_MEAN|0.57||0.663|TWO_SIDED|95.0|-0.89|1.391|||Mixed Models Analysis|||||1.391|-0.890|0.663
72470089|NCT02783573|144464437|SUPERIORITY||LS Mean Difference (Final Values)|-0.22|STANDARD_ERROR_OF_MEAN|0.6||0.717|TWO_SIDED|95.0|-1.423|0.983|||Mixed Models Analysis|||||0.983|-1.423|0.717
72563191|NCT00442546|144658158|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.49|STANDARD_ERROR_OF_MEAN|0.439||0.2682||95.0|-1.364|0.385|||ANOVA||Mean difference (final values) = Least squares mean difference|Month 3||0.385|-1.364|0.2682
72563192|NCT00442546|144658158|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.294|STANDARD_ERROR_OF_MEAN|0.413||0.4784||95.0|-1.116|0.528|||ANOVA||Mean difference (final values) = Least squares mean difference|Month 3||0.528|-1.116|0.4784
72470090|NCT02783573|144464439|SUPERIORITY||LS Mean Difference (Final Values)|0.3|STANDARD_ERROR_OF_MEAN|2.34||0.899|TWO_SIDED|95.0|-4.297|4.889|||Mixed Models Analysis|||||4.889|-4.297|0.899
72563193|NCT00442546|144658158|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.661|STANDARD_ERROR_OF_MEAN|0.298||0.0255||95.0|0.084|1.239|||ANOVA||Mean difference (final values) = Least squares mean difference|Month 6||1.239|0.084|0.0255
72563194|NCT00442546|144658158|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.448|STANDARD_ERROR_OF_MEAN|0.314||0.1591||95.0|-0.18|1.076|||ANOVA||Mean difference (final values) = Least squares mean difference|Month 6||1.076|-0.180|0.1591
72563195|NCT00442546|144658159|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.786|STANDARD_ERROR_OF_MEAN|0.372||0.0359||95.0|-1.52|-0.052|||ANOVA||Mean difference (final values) = Least squares mean difference|Discharge||-0.052|-1.520|0.0359
72563196|NCT00442546|144658159|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.907|STANDARD_ERROR_OF_MEAN|0.374||0.0161||95.0|-1.644|-0.17|||ANOVA||Mean difference (final values) = Least squares mean difference|Discharge||-0.170|-1.644|0.0161
72563197|NCT00442546|144658159|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.105|STANDARD_ERROR_OF_MEAN|0.319||0.7416||95.0|-0.733|0.523|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2||0.523|-0.733|0.7416
72563198|NCT00442546|144658159|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.301|STANDARD_ERROR_OF_MEAN|0.324||0.3527||95.0|-0.939|0.336|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2||0.336|-0.939|0.3527
72563199|NCT00442546|144658159|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.184|STANDARD_ERROR_OF_MEAN|0.3||0.5419||95.0|-0.776|0.409|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4||0.409|-0.776|0.5419
72563200|NCT00442546|144658159|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.026|STANDARD_ERROR_OF_MEAN|0.305||0.9333||95.0|-0.628|0.577|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4||0.577|-0.628|0.9333
72563201|NCT00442546|144658159|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.354|STANDARD_ERROR_OF_MEAN|0.24||0.142||95.0|-0.827|0.12|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET||0.120|-0.827|0.1420
72563202|NCT00442546|144658159|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.053|STANDARD_ERROR_OF_MEAN|0.245||0.829||95.0|-0.535|0.429|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET||0.429|-0.535|0.8290
72563203|NCT00442546|144658159|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.111|STANDARD_ERROR_OF_MEAN|0.441||0.0138||95.0|-1.989|-0.233|||ANOVA||Mean difference (final values) = Least squares mean difference|Month 3||-0.233|-1.989|0.0138
72470091|NCT02783573|144464439|SUPERIORITY||LS Mean Difference (Final Values)|-3.01|STANDARD_ERROR_OF_MEAN|2.16||0.164|TWO_SIDED|95.0|-7.267|1.238|||Mixed Models Analysis|||||1.238|-7.267|0.164
72470092|NCT02783573|144464440|SUPERIORITY||LS Mean Difference (Final Values)|-1.26|STANDARD_ERROR_OF_MEAN|0.82||0.126|TWO_SIDED|95.0|-2.891|0.362|||Mixed Models Analysis|||||0.362|-2.891|0.126
72470093|NCT02783573|144464440|SUPERIORITY||LS Mean Difference (Final Values)|-0.15|STANDARD_ERROR_OF_MEAN|0.86||0.862|TWO_SIDED|95.0|-1.867|1.566|||Mixed Models Analysis|||||1.566|-1.867|0.862
72470094|NCT02783573|144464441|SUPERIORITY||LS Mean Difference (Final Values)|-37.55|STANDARD_ERROR_OF_MEAN|37.49||0.343|TWO_SIDED|95.0|-122.35|47.26|||ANCOVA|||||47.26|-122.35|0.343
72470095|NCT02783573|144464441|SUPERIORITY||LS Mean Difference (Final Values)|-40.72|STANDARD_ERROR_OF_MEAN|35.12||0.276|TWO_SIDED|95.0|-120.17|38.73|||ANCOVA|||||38.73|-120.17|0.276
72470096|NCT02783573|144464442|SUPERIORITY||LS Mean Difference (Final Values)|-61.94|STANDARD_ERROR_OF_MEAN|31.3||0.079|TWO_SIDED|95.0|-132.75|8.87|||ANCOVA|||||8.87|-132.75|0.079
72370511|NCT00488683|144251632|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.08||||0.59||95.0|||||Non-parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Spearman correlation coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one month after booster vaccination for the serogroup A||||0.59
72459391|NCT00657709|144441445|NON_INFERIORITY_OR_EQUIVALENCE|{PConcomitant Vaccine +rMenB+OMV NZ lot1+lot2+lot3 minus PConcomitant Vaccine}|percentage group difference|-2.0|||||TWO_SIDED|95.0|-4.0|0.0|||Miettinen and Nurminen|||Immunogenicity of the 7 components of PCV7 when given concomitantly with rMenB and DTPa-HBV-IPV at 2, 4 and 6 months of age would be considered non-inferior to that of the routine vaccinations given alone, if the lower limit of the two-sided 95% confidence interval for the difference in the percentage of subjects with antibody response greater than the cutoff of ≥0.35 μg/mL was, for the pneumococcal antigen PnC4.||0|-4|
72459392|NCT00657709|144441445|NON_INFERIORITY_OR_EQUIVALENCE|{PConcomitant Vaccine +rMenB+OMV NZ lot1+lot2+lot3 minus PConcomitant Vaccine}|Percentage group difference|2.0|||||TWO_SIDED|95.0|-4.0|8.0|||Miettinen and Nurminen|||Immunogenicity of the 7 components of PCV7 when given concomitantly with rMenB and DTPa-HBV-IPV at 2, 4, and 6 months of age would be considered non-inferior to that of the routine vaccinations given alone, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response greater than the cutoff of ≥0.35 μg/mL, was, for PnC 6B antigen greater than -10%.||8|-4|
72459393|NCT00657709|144441445|NON_INFERIORITY_OR_EQUIVALENCE|{PConcomitant Vaccine +rMenB+OMV NZ lot1+lot2+lot3 minus PConcomitant Vaccine}|Percentage group difference|0.0|||||TWO_SIDED|95.0|-2.0|1.0|||Miettinen and Nurminen|||Immunogenicity of the 7 components of PCV7 when given concomitantly with rMenB and DTPa\_HBV-IPV vaccine at 2, 4, and 6 months of age would be considered non-inferior to that of the routine vaccinations given alone, if the lower limit of the two sided 95% CI for the difference in the percentage of subjects with antibody response greater than the cutoff of ≥0.35 μg/mL, was, for PnC 9V, greater than -10%.||1|-2|
72459394|NCT00657709|144441445|NON_INFERIORITY_OR_EQUIVALENCE|{PConcomitant Vaccine +rMenB+OMV NZ lot1+lot2+lot3 minus PConcomitant Vaccine}|Percentage group difference|0.0|||||TWO_SIDED|95.0|-4.0|3.0|||Miettinen and Nurminen|||Immunogenicity of the 7 components of PCV7 vaccine when given concomitantly with rMenB and DTPa-HBV-IPV at 2, 4, and 6 months of age would be considered non-inferior to that of the routine vaccinations given alone, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response greater than the cutoff of ≥0.35 μg/mL, was, for PnC14 antigen, greater than -10%.||3|-4|
72459395|NCT00657709|144441445|NON_INFERIORITY_OR_EQUIVALENCE|{PConcomitant Vaccine +rMenB+OMV NZ lot1+lot2+lot3 minus PConcomitant Vaccine}|Percentage group difference|-1.0|||||TWO_SIDED|95.0|-3.0|1.0|||Miettinen and Nurminen|||Immunogenicity of the 7 components of PCV7 when given concomitantly with rMenB and DTPa-HBV-IPV vaccine at 2, 4, and 6 months of age would be considered non-inferior to that of the routine vaccinations given alone, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response greater than the cutoff of ≥0.35 μg/mL, was, for PnC 18C antigen greater than -10%.||1|-3|
72459396|NCT00657709|144441445|NON_INFERIORITY_OR_EQUIVALENCE|{PConcomitant Vaccine +rMenB+OMV NZ lot1+lot2+lot3 minus PConcomitant Vaccine}|Percentage group difference|0.0|||||TWO_SIDED|95.0|-3.0|4.0|||Miettinen and Nurminen|||Immunogenicity of the 7 components of PCV7 when given concomitantly with rMenB and DTPa-HBV-IPV vaccine at 2, 4 and 6 months of age would be considered non-inferior to that of the routine vaccinations given alone, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response greater than the cutoff of ≥0.35 μg/mL, was for PnC 19F antigen, greater than -10%.||4|-3|
72459397|NCT00657709|144441445|NON_INFERIORITY_OR_EQUIVALENCE|{PConcomitant Vaccine +rMenB+OMV NZ lot1+lot2+lot3 minus PConcomitant Vaccine}|Percentage group difference|-3.0|||||TWO_SIDED|95.0|-8.0|2.0|||Miettinen and Nurminen|||Immunogenicity of the 7 components of PCV7 when given concomitantly with rMenB and DTPa-HBV-IPV vaccine at 2, 4, and 6 months of age would be considered non-inferior to that of the routine vaccinations given alone, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response greater than the cutoff of ≥0.35 μg/mL, was for PnC 23F antigen, greater than -10%.||2|-8|
72459398|NCT00657709|144441446|NON_INFERIORITY_OR_EQUIVALENCE|{PConcomitant Vaccine +rMenB+OMV NZ lot1+lot2+lot3 minus PConcomitant Vaccine}|Percentage group difference|-3.0|||||TWO_SIDED|95.0|-9.0|4.0|||Miettinen and Nurminen|||Immunogenicity of the FHA antigen of DTPa-HBV-IPV when given concomitantly with rMenB and PCV7 vaccine at 2, 4 and 6 months of age would be considered non-inferior to that of the routine vaccinations given alone, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects was greater than -10%.||4|-9|
72459399|NCT00657709|144441446|NON_INFERIORITY_OR_EQUIVALENCE|{PConcomitant Vaccine +rMenB+OMV NZ lot1+lot2+lot3 minus PConcomitant Vaccine}|Percentage group difference|-9.0|||||TWO_SIDED|95.0|-16.0|-3.0|||Miettinen and Nurminen|||Immunogenicity of the Pertactin antigen of DTPa-HBV-IPV when given concomitantly with rMenB and PCV7 at 2, 4 and 6 months of age would be considered non-inferior to that of the routine vaccinations given alone, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects was greater than -10%.||-3|-16|
72459400|NCT00657709|144441446|NON_INFERIORITY_OR_EQUIVALENCE|{PConcomitant Vaccine +rMenB+OMV NZ lot1+lot2+lot3 minus PConcomitant Vaccine}|Percentage group difference|-2.0|||||TWO_SIDED|95.0|-7.0|2.0|||Miettinen and Nurminen|||Immunogenicity of the PT antigen of DTPa-HBV-IPV vaccine given concomitantly with rMenB and PCV7 vaccine at 2, 4, and 6 months of age would be considered non-inferior to that of the routine vaccinations given alone if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects was greater than -10%.||2|-7|
72459401|NCT01280656|144441464|SUPERIORITY_OR_OTHER|||||||0.003|TWO_SIDED||||||Chi-squared|||||||0.003
72459402|NCT01280656|144441465|SUPERIORITY_OR_OTHER|||||||0.693|||||||Chi-squared|||||||0.693
72459403|NCT01280656|144441467|SUPERIORITY_OR_OTHER|||||||0.573|TWO_SIDED||||||Chi-squared|||||||0.573
72459404|NCT01280656|144441469|SUPERIORITY_OR_OTHER|||||||0.982|TWO_SIDED||||||Chi-squared|||Mean at the site||||0.982
72563204|NCT00442546|144658159|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.503|STANDARD_ERROR_OF_MEAN|0.416||0.23||95.0|-1.332|0.325|||ANOVA||Mean difference (final values) = Least squares mean difference|Month 3||0.325|-1.332|0.2300
72370512|NCT00488683|144251632|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|-0.1||||0.51||95.0|||||Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one month after booster vaccination for the serogroup C||||0.51
72459405|NCT01280656|144441469|SUPERIORITY_OR_OTHER|||||||0.012|TWO_SIDED||||||Chi-squared|||Mean at home||||0.012
72459406|NCT01280656|144441470|SUPERIORITY_OR_OTHER|||||||0.476|||||||t-test, 2 sided|||Responders vs Non-responders||||0.476
72620937|NCT00452400|144772839|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.202|STANDARD_ERROR_OF_MEAN|0.032|<|0.0001||95.0|0.14|0.264|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 2 mcg qd minus Placebo|||0.264|0.140|<0.0001
72459407|NCT01280656|144441470|SUPERIORITY_OR_OTHER|||||||0.32|||||||t-test, 2 sided|||Responders vs Non-Responders||||0.320
72459408|NCT01280656|144441471|SUPERIORITY_OR_OTHER|||||||0.792|TWO_SIDED||||||Chi-squared|||||||0.792
72459409|NCT01280656|144441472|SUPERIORITY_OR_OTHER|||||||0.202|TWO_SIDED||||||Chi-squared|||||||0.202
72459410|NCT01280656|144441473|SUPERIORITY_OR_OTHER|||||||0.921|TWO_SIDED||||||Chi-squared|||||||0.921
72459411|NCT01280656|144441474|SUPERIORITY_OR_OTHER|||||||0.202|TWO_SIDED||||||Chi-squared|||||||0.202
72459412|NCT01280656|144441475|SUPERIORITY_OR_OTHER|||||||0.973|TWO_SIDED||||||Chi-squared|||Total||||0.973
72459413|NCT03293238|144441494|SUPERIORITY|||||||0.527|||||||ANOVA|||||||0.527
72459414|NCT03293238|144441495|SUPERIORITY|||||||0.749|||||||ANOVA|||||||0.749
72459415|NCT01313663|144441527|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.92|||||TWO_SIDED|90.0|0.32|2.65|||||HRs were estimated using the Pike estimator. The hazard ratio and p-value from the stratified log-rank test were adjusted for disease stage at Baseline only, due to sparse data.|||2.65|0.32|
72459416|NCT01574105|144441588|NON_INFERIORITY_OR_EQUIVALENCE|Sample sizes of 26 in heparin resistant group and 26 in heparin sensitive group achieve 90% power at the 0.025 level of significance to detect a non-inferiority using a one-sided two-sample t-test, assuming a noninferiority margin is 200 milliliters in the postoperative chest tube loss.|||||<|0.1||95.0|||||ANCOVA|||For the analysis of the patient characteristics Wilcoxon, Chi-square and Fischer's exact tests were used. An upper bound of a two-sided 95% confidence interval (CI) of the mean difference between resistant and sensitive groups for all values of chest tube losses was computed by analysis of covariance (ANCOVA), and compared with pre-specified noninferiority limits. Covariates in the ANCOVA model included patient characteristics differing between two groups with a p-value \<0.1.||||<0.1
72459417|NCT00608959|144441590|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.91|STANDARD_DEVIATION|1.563|<|0.001||95.0|-2.55|-1.26|||t-test, 2 sided|||Based on a two-sided test at the 5% level of significance, and assuming a SD of 1.3, a sample size of 20 subjects would provide 90% power to detect a mean change of 0.942. No information was available concerning the within-subject variability between the arms.||-1.26|-2.55|<0.001
72459418|NCT00608959|144441590|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-1.87|STANDARD_DEVIATION|1.656|<|0.001||95.0|-2.57|-1.17|||t-test, 2 sided|||Based on a two-sided test at the 5% level of significance, and assuming a SD of 1.3, a sample size of 20 subjects would provide 90% power to detect a mean change of 0.942. No information was available concerning the within-subject variability between the arms.||-1.17|-2.57|<0.001
72459419|NCT04351243|144441593|SUPERIORITY||Risk Difference (RD)|0.05||||0.1885|TWO_SIDED|95.0|-0.06|0.17||one-sided p value|Mantel Haenszel|||||0.17|-0.06|0.1885
72459420|NCT01248715|144441603|SUPERIORITY|||||||0.46|||||||Wilcoxon (Mann-Whitney)|||||||.460
72459421|NCT01248715|144441604|SUPERIORITY|||||||0.9999|||||||Wilcoxon (Mann-Whitney)|||||||.9999
72459422|NCT01248715|144441605|SUPERIORITY|||||||0.732|||||||Wilcoxon (Mann-Whitney)|||||||.732
72459423|NCT01248715|144441606|SUPERIORITY|||||||0.9999|||||||Wilcoxon (Mann-Whitney)|||||||.9999
72370513|NCT00488683|144251632|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.02||||0.9||95.0|||||Non-parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Spearman correlation coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one month after booster vaccination for the serogroup C||||0.9
72370514|NCT00488683|144251632|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.39||||0.02||95.0|||||Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one month after booster vaccination for the serogroup W-135||||0.02
72370515|NCT00488683|144251632|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.19||||0.2||95.0|||||Non-parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Spearman correlation coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one month after booster vaccination for the serogroup W-135||||0.20
72459424|NCT01248715|144441607|SUPERIORITY|||||||0.685|||||||Wilcoxon (Mann-Whitney)|||||||.685
72459425|NCT01248715|144441608|SUPERIORITY|||||||0.796|||||||Wilcoxon (Mann-Whitney)|||||||.796
72459426|NCT01248715|144441609|SUPERIORITY|||||||0.9999|||||||Wilcoxon (Mann-Whitney)|||||||.9999
72459427|NCT01215253|144441645|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.117|TWO_SIDED|95.0|0.67|1.05|||Regression, Cox|||||1.05|0.67|0.117
72459428|NCT01215253|144441646|SUPERIORITY||Hazard Ratio (HR)|0.98||||0.891|TWO_SIDED|95.0|0.76|1.26|||Regression, Cox|||||1.26|0.76|0.891
72459429|NCT01215253|144441647|SUPERIORITY||Hazard Ratio (HR)|0.7||||0.028|TWO_SIDED|95.0|0.51|0.96|||Anderson-Gill analysis|||||0.96|0.51|0.028
72459430|NCT01215253|144441648|SUPERIORITY||Hazard Ratio (HR)|0.75||||0.398|TWO_SIDED|95.0|0.38|1.47|||Regression, Cox|||||1.47|0.38|0.398
72459431|NCT01215253|144441649|SUPERIORITY||Hazard Ratio (HR)|1.1||||0.316|TWO_SIDED|95.0|0.91|1.34|||Regression, Cox|||||1.34|0.91|0.316
72459432|NCT01215253|144441650|SUPERIORITY||Hazard Ratio (HR)|1.07||||0.577|TWO_SIDED|95.0|0.84|1.37|||Regression, Cox|||||1.37|0.84|0.577
72459433|NCT01215253|144441651|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.871|TWO_SIDED|95.0|0.69|1.37|||Regression, Cox|||||1.37|0.69|0.871
72459434|NCT01215253|144441652|SUPERIORITY|||||||0.508|||||||nonparametric Wilcoxon rank-sum test|||||||0.508
72459435|NCT01215253|144441653|SUPERIORITY|||||||0.948|||||||nonparametric Wilcoxon rank-sum test|||||||0.948
72459436|NCT01215253|144441654|SUPERIORITY||Hazard Ratio (HR)|0.73||||0.038|TWO_SIDED|95.0|0.55|0.98|||Regression, Cox|||||0.98|0.55|0.038
72459437|NCT01215253|144441655|SUPERIORITY||Hazard Ratio (HR)|1.01||||0.947|TWO_SIDED|95.0|0.73|1.41|||Regression, Cox|||||1.41|0.73|0.947
72459438|NCT01215253|144441656|SUPERIORITY||Hazard Ratio (HR)|0.74||||0.414|TWO_SIDED|95.0|0.36|1.52|||Anderdon-Gill analysis|||||1.52|0.36|0.414
72563205|NCT00442546|144658159|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.175|STANDARD_ERROR_OF_MEAN|0.268||0.5151||95.0|-0.36|0.711|||ANOVA||Mean difference (final values) = Least squares mean difference|Month 6||0.711|-0.360|0.5151
72563206|NCT00442546|144658159|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.433|STANDARD_ERROR_OF_MEAN|0.295||0.146||95.0|-0.155|1.022|||ANOVA||Mean difference (final values) = Least squares mean difference|Month 6||1.022|-0.155|0.1460
72459439|NCT00674609|144441657|SUPERIORITY_OR_OTHER_LEGACY||estimated mean treatment difference|-0.67||||0.014|TWO_SIDED|95.0|-1.21|-0.14|||ANCOVA|||The change in mean pain NRS score (average pain) was analyzed using analysis of covariance (ANCOVA) with the baseline value as a covariate and region and treatment group as factors. The null hypothesis was that of no treatment difference.||-0.14|-1.21|0.014
72459440|NCT00674609|144441657|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-0.32||||0.244|TWO_SIDED|95.0|-0.86|0.22|||ANCOVA|||The change in mean pain NRS score (average pain) was analyzed using analysis of covariance (ANCOVA) with the baseline value as a covariate and region and treatment group as factors. The null hypothesis was that of no treatment difference.||0.22|-0.86|0.244
72459441|NCT00674609|144441658|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-0.31||||0.346|TWO_SIDED|95.0|-0.97|0.34|||ANCOVA|||Each secondary variable was tested using a two-sided significance level of α=0.05, unless otherwise specified. P-values of \< 0.05 were considered statistically significant. If the overall treatment effect for the secondary variables was statistically significant then treatment comparisons was made between active treatments and placebo.||0.34|-0.97|0.346
72459442|NCT00674609|144441658|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|0.02||||0.95|TWO_SIDED|95.0|-0.64|0.68|||ANCOVA|||Each secondary variable was tested using a two-sided significance level of α=0.05, unless otherwise specified. P-values of \< 0.05 were considered statistically significant. If the overall treatment effect for the secondary variables was statistically significant then treatment comparisons was made between active treatments and placebo.||0.68|-0.64|0.95
72459443|NCT00674609|144441659|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|0.49||||0.11|TWO_SIDED|95.0|-0.11|1.09|||ANCOVA|||Each secondary variable was tested using a two-sided significance level of α=0.05, unless otherwise specified. P-values of \< 0.05 were considered statistically significant. If the overall treatment effect for the secondary variables was statistically significant then treatment comparisons was made between active treatments and placebo.||1.09|-0.11|0.11
72459444|NCT00674609|144441659|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|0.46||||0.126|TWO_SIDED|95.0|-0.13|1.05|||ANCOVA|||Each secondary variable was tested using a two-sided significance level of α=0.05, unless otherwise specified. P-values of \< 0.05 were considered statistically significant. If the overall treatment effect for the secondary variables was statistically significant then treatment comparisons was made between active treatments and placebo.||1.05|-0.13|0.126
72459445|NCT00674609|144441660|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|0.65||||0.045|TWO_SIDED|95.0|0.01|1.28|||ANCOVA|||Each secondary variable was tested using a two-sided significance level of α=0.05, unless otherwise specified. P-values of \< 0.05 were considered statistically significant. If the overall treatment effect for the secondary variables was statistically significant then treatment comparisons was made between active treatments and placebo.||1.28|0.01|0.045
72459446|NCT00674609|144441660|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|0.62||||0.053|TWO_SIDED|95.0|-0.01|1.25|||ANCOVA|||Each secondary variable was tested using a two-sided significance level of α=0.05, unless otherwise specified. P-values of \< 0.05 were considered statistically significant. If the overall treatment effect for the secondary variables was statistically significant then treatment comparisons was made between active treatments and placebo.||1.25|-0.01|0.053
72459447|NCT00674609|144441661|SUPERIORITY_OR_OTHER_LEGACY||estimated mean treatment difference|0.83||||0.016|TWO_SIDED|95.0|0.16|1.51|||ANCOVA|||Each secondary variable was tested using a two-sided significance level of α=0.05, unless otherwise specified. P-values of \< 0.05 were considered statistically significant. If the overall treatment effect for the secondary variables was statistically significant then treatment comparisons was made between active treatments and placebo.||1.51|0.16|0.016
72459448|NCT00674609|144441661|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|0.66||||0.056|TWO_SIDED|95.0|-0.02|1.33|||ANCOVA|||Each secondary variable was tested using a two-sided significance level of α=0.05, unless otherwise specified. P-values of \< 0.05 were considered statistically significant. If the overall treatment effect for the secondary variables was statistically significant then treatment comparisons was made between active treatments and placebo.||1.33|-0.02|0.056
72470097|NCT02783573|144464442|SUPERIORITY||LS Mean Difference (Final Values)|-34.15|STANDARD_ERROR_OF_MEAN|31.27||0.303|TWO_SIDED|95.0|-104.88|36.59|||ANCOVA|||||36.59|-104.88|0.303
72470098|NCT02783573|144464443|SUPERIORITY||LS Mean Difference (Final Values)|16.32|STANDARD_ERROR_OF_MEAN|14.29||0.283|TWO_SIDED|95.0|-16.015|48.659|||ANCOVA|||||48.659|-16.015|0.283
72470099|NCT02783573|144464443|SUPERIORITY||LS Mean Difference (Final Values)|-13.05|STANDARD_ERROR_OF_MEAN|13.21||0.349|TWO_SIDED|95.0|-42.929|16.82|||ANCOVA|||||16.820|-42.929|0.349
72470100|NCT02783573|144464444|SUPERIORITY||LS Mean Difference (Final Values)|1.59|STANDARD_ERROR_OF_MEAN|2.23||0.494|TWO_SIDED|95.0|-3.457|6.64|||ANCOVA|||||6.640|-3.457|0.494
72470101|NCT02783573|144464444|SUPERIORITY||LS Mean Difference (Final Values)|-2.13|STANDARD_ERROR_OF_MEAN|2.04||0.323|TWO_SIDED|95.0|-6.743|2.481|||ANCOVA|||||2.481|-6.743|0.323
72563207|NCT00442546|144658160|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.258|STANDARD_ERROR_OF_MEAN|0.463||0.5786||95.0|-1.17|0.655|||ANOVA||Mean difference (final values) = Least squares mean difference|Discharge||0.655|-1.170|0.5786
72563208|NCT00442546|144658160|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.025|STANDARD_ERROR_OF_MEAN|0.467||0.957||95.0|-0.895|0.946|||ANOVA||Mean difference (final values) = Least squares mean difference|Discharge||0.946|-0.895|0.9570
72563209|NCT00442546|144658160|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.008|STANDARD_ERROR_OF_MEAN|0.434||0.986||95.0|-0.862|0.847|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2||0.847|-0.862|0.9860
72563210|NCT00442546|144658160|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.151|STANDARD_ERROR_OF_MEAN|0.442||0.7336||95.0|-1.021|0.72|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2||0.720|-1.021|0.7336
72470102|NCT02783573|144464445|SUPERIORITY||LS Mean Difference (Final Values)|2.22|STANDARD_ERROR_OF_MEAN|13.76||0.873|TWO_SIDED|95.0|-26.569|31.017|||ANCOVA|||||31.017|-26.569|0.873
72459449|NCT00674609|144441662|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|0.68||||0.021|TWO_SIDED|95.0|0.1|1.25|||ANCOVA|||Each secondary variable was tested using a two-sided significance level of α=0.05, unless otherwise specified. P-values of \< 0.05 were considered statistically significant. If the overall treatment effect for the secondary variables was statistically significant then treatment comparisons was made between active treatments and placebo.||1.25|0.10|0.021
72563211|NCT00442546|144658160|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.384|STANDARD_ERROR_OF_MEAN|0.365||0.2939||95.0|-0.336|1.104|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4||1.104|-0.336|0.2939
72563212|NCT00442546|144658160|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.274|STANDARD_ERROR_OF_MEAN|0.372||0.4615||95.0|-0.459|1.008|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4||1.008|-0.459|0.4615
72370516|NCT00488683|144251632|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.18||||0.34||95.0|||||Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one month after booster vaccination for the serogroup Y||||0.34
72459450|NCT00674609|144441662|SUPERIORITY_OR_OTHER_LEGACY||Estimated treatment difference|0.64||||0.028|TWO_SIDED|95.0|0.07|1.22|||ANCOVA|||Each secondary variable was tested using a two-sided significance level of α=0.05, unless otherwise specified. P-values of \< 0.05 were considered statistically significant. If the overall treatment effect for the secondary variables was statistically significant then treatment comparisons was made between active treatments and placebo.||1.22|0.07|0.028
72459451|NCT00674609|144441663|SUPERIORITY_OR_OTHER_LEGACY||estimated mean treatment difference|2.47||||0.443|TWO_SIDED|95.0|-3.87|8.81|||ANCOVA|||Analysis of the change from baseline was assessed using ANCOVA, adjusting for the effects of the baseline value. The significance of the treatment effect, after adjusting for the baseline value, was assessed using the F-test from the ANCOVA. If found significant at the 5% level, then the mean difference between treatments together with 95% CI were presented.||8.81|-3.87|0.443
72459452|NCT00674609|144441663|SUPERIORITY_OR_OTHER_LEGACY||estimated mean treatment difference|0.84||||0.793|TWO_SIDED|95.0|-5.46|7.13|||ANCOVA|||Analysis of the change from baseline was assessed using ANCOVA, adjusting for the effects of the baseline value. The significance of the treatment effect, after adjusting for the baseline value, was assessed using the F-test from the ANCOVA. If found significant at the 5% level, then the mean difference between treatments together with 95% CI were presented.||7.13|-5.46|0.793
72459453|NCT00674609|144441664|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-1.04||||0.619|TWO_SIDED|95.0|-5.23|3.15|||ANCOVA|||Change in pain scores on-treatment were be compared between groups using analysis of covariance (ANCOVA). The baseline pain score was fitted as a covariate in the model. The significance of the treatment effect after adjusting for baseline pain score was assessed using the F-test from the ANCOVA. If this was significant at the 5% level, then the mean difference between treatments together with the 95% confidence interval was presented for Sativex versus placebo and THC versus placebo.||3.15|-5.23|0.619
72459454|NCT00674609|144441664|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-4.07||||0.048|TWO_SIDED|95.0|-8.1|-0.05|||ANCOVA|||Change in pain scores on-treatment were be compared between groups using analysis of covariance (ANCOVA). The baseline pain score was fitted as a covariate in the model. The significance of the treatment effect after adjusting for baseline pain score was assessed using the F-test from the ANCOVA. If this was significant at the 5% level, then the mean difference between treatments together with the 95% confidence interval was presented for Sativex versus placebo and THC versus placebo.||-0.05|-8.10|0.048
72459455|NCT00674609|144441665|SUPERIORITY_OR_OTHER_LEGACY||estimated mean treatment difference|-0.04||||0.688|TWO_SIDED|95.0|-0.25|0.16|||Regression, Logistic|||The on-treatment data was calculated from all available data during the last three days. The number of days the escape medication was used out of the last three days taken in the study was compared between treatments using logistic regression with a cumulative logit model. From this analysis the frequency distribution (%) of number days escape medication was used was presented together with the odds ratio, p-value and 95% CI for the treatment contrasts.||0.16|-0.25|0.688
72459456|NCT00674609|144441665|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|0.01||||0.899|TWO_SIDED|95.0|-0.19|0.22|||Regression, Logistic|||The on-treatment data was calculated from all available data during the last three days. The number of days the escape medication was used out of the last three days taken in the study was compared between treatments using logistic regression with a cumulative logit model. From this analysis the frequency distribution (%) of number days escape medication was used was presented together with the odds ratio, p-value and 95% CI for the treatment contrasts.||0.22|-0.19|0.899
72459457|NCT03884478|144441673|OTHER||Mean Difference (Final Values)|3.25|STANDARD_ERROR_OF_MEAN|0.82||0.0001|TWO_SIDED||||||Mixed Models Analysis|||As detailed in the statistical analysis plan, a multi-level model which held constant participant age, race, ethnicity, relationship status, sexual identity, and sexual minority interpersonal stigma exposure in examining Time\*Arm interactions on weekly drinks. To probe the significant Alcohol+Coping Arm\*T2 interaction, a Tukey post-hoc test examined the change in weekly drinks from baseline to the 2 month follow-up in the Alcohol+Coping Arm versus the Control Arm.||||.0001
72470103|NCT02783573|144464445|SUPERIORITY||LS Mean Difference (Final Values)|-15.2|STANDARD_ERROR_OF_MEAN|15.43||0.337|TWO_SIDED|95.0|-47.488|17.096|||ANCOVA|||||17.096|-47.488|0.337
72470104|NCT02783573|144464446|SUPERIORITY||LS Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.01||0.927|TWO_SIDED|95.0|-0.015|0.017|||ANCOVA|||||0.017|-0.015|0.927
72563213|NCT00442546|144658160|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.161|STANDARD_ERROR_OF_MEAN|0.347||0.6433||95.0|-0.845|0.523|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET||0.523|-0.845|0.6433
72370517|NCT00488683|144251632|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.33||||0.04||95.0|||||Non-parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Spearman correlation coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one month after booster vaccination for the serogroup Y||||0.04
72370518|NCT00488683|144251632|SUPERIORITY_OR_OTHER||R-square|0.08||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one month after booster vaccination for the serogroup A||||
72459458|NCT03884478|144441673|OTHER||Mean Difference (Final Values)|2.31|STANDARD_ERROR_OF_MEAN|0.77||0.005|TWO_SIDED||||||Mixed Models Analysis|||As detailed in the statistical analysis plan, a multi-level model held constant participant age, race, ethnicity, relationship status, sexual identity, and sexual minority interpersonal stigma exposure in examining Time\*Arm interactions on weekly drinks. To probe the significant Alcohol+Control Arm\*T2 interaction, a Tukey post-hoc test examined the change in weekly drinks from baseline to the 2 month follow-up in the Alcohol+Control Arm versus the Control Arm.||||.005
72459459|NCT03884478|144441673|OTHER||Mean Difference (Final Values)|0.94|STANDARD_ERROR_OF_MEAN|0.82||0.25|TWO_SIDED||||||Mixed Models Analysis|||As detailed in the statistical analysis plan, a multi-level model which held constant participant age, race, ethnicity, relationship status, sexual identity, and sexual minority interpersonal stigma exposure in examining Time\*Arm interactions on weekly drinks. To probe the significant Alcohol+Coping Arm\*Time interaction, a Tukey post-hoc test examined the change in weekly drinks from baseline to the 2 month follow-up in the Alcohol+Coping Arm versus the Alcohol Only Arm.||||.25
72459460|NCT03884478|144441674|OTHER||Mean Difference (Final Values)|1.9|STANDARD_ERROR_OF_MEAN|0.84||0.025|TWO_SIDED||||||Mixed Models Analysis|||As detailed in the statistical analysis plan, a multi-level model which held constant participant age, race, ethnicity, relationship status, sexual identity, and sexual minority interpersonal stigma exposure in examining Time\*Arm interactions on weekly drinks. To probe the significant Alcohol+Coping Arm\*Time interaction, a Tukey post-hoc test examined the change in weekly drinks from baseline to the 4 month follow-up in the Alcohol+Coping Arm versus the Control Arm.||||.025
72459461|NCT03884478|144441674|OTHER||Mean Difference (Final Values)|1.24|STANDARD_ERROR_OF_MEAN|0.79||0.11|TWO_SIDED||||||Mixed Models Analysis|||As detailed in the statistical analysis plan, a multi-level model which held constant participant age, race, ethnicity, relationship status, sexual identity, and sexual minority interpersonal stigma exposure in examining Time\*Arm interactions on weekly drinks. To probe the significant Alcohol+Coping Arm\*T2 interaction, a Tukey post-hoc test examined the change in weekly drinks from baseline to the 4 month follow-up in the Alcohol+Control Arm versus the Control Arm.||||.11
72459462|NCT03884478|144441674|OTHER||Mean Difference (Final Values)|0.66|STANDARD_ERROR_OF_MEAN|0.84||0.66|TWO_SIDED||||||Mixed Models Analysis|||As detailed in the statistical analysis plan, a multi-level model which held constant participant age, race, ethnicity, relationship status, sexual identity, and sexual minority interpersonal stigma exposure in examining Time\*Arm interactions on weekly drinks. To probe the significant Alcohol+Coping Arm\*Time interaction, a Tukey post-hoc test examined the change in weekly drinks from baseline to the 4 month follow-up in the Alcohol+Coping Arm versus the Alcohol+Control Arm.||||.66
72459463|NCT03884478|144441675|OTHER||Mean Difference (Final Values)|1.51|STANDARD_ERROR_OF_MEAN|0.25|<|0.001|TWO_SIDED||||||Mixed Models Analysis|||As detailed in the statistical analysis plan, a multi-level model which held constant participant age, race, ethnicity, relationship status, sexual identity, and sexual minority interpersonal stigma exposure in examining Time\*Arm interactions on weekly drinks. To probe the significant Alcohol+Coping Arm\*Time interaction, a Tukey post-hoc test examined the change in peak drinks from baseline to the 2 month follow-up in the Alcohol+Coping Arm versus the Control Arm.||||<.001
72459464|NCT03884478|144441675|OTHER||Mean Difference (Final Values)|1.48|STANDARD_ERROR_OF_MEAN|0.23|<|0.001|TWO_SIDED||||||Mixed Models Analysis|||As detailed in the statistical analysis plan, a multi-level model which held constant participant age, race, ethnicity, relationship status, sexual identity, and sexual minority interpersonal stigma exposure in examining Time\*Arm interactions on peak drinks. To probe the significant Alcohol+Control Arm\*Time interaction, a Tukey post-hoc test examined the change in peak drinks at the 2 month follow-up in the Alcohol+Control Arm versus the Control Arm.||||<.001
72459465|NCT03884478|144441675|OTHER||Mean Difference (Final Values)|0.04|STANDARD_ERROR_OF_MEAN|0.25||0.88|TWO_SIDED||||||Mixed Models Analysis|||As detailed in the statistical analysis plan, a multi-level model which held constant participant age, race, ethnicity, relationship status, sexual identity, and sexual minority interpersonal stigma exposure in examining Time\*Arm interactions on peak drinks. To probe the significant Alcohol+Coping Arm\*Time interaction, a Tukey post-hoc test examined the change in peak drinks at the 2 month follow-up in the Alcohol+Coping Arm versus the Alcohol+Control Arm.||||.88
72459466|NCT03884478|144441676|OTHER||Mean Difference (Final Values)|0.55|STANDARD_ERROR_OF_MEAN|0.26||0.03|TWO_SIDED||||||Mixed Models Analysis|||As detailed in the statistical analysis plan, a multi-level model which held constant participant age, race, ethnicity, relationship status, sexual identity, and sexual minority interpersonal stigma exposure in examining Time\*Arm interactions on weekly drinks. To probe the significant Alcohol+Coping Arm\*Time interaction, a Tukey post-hoc test examined the change in weekly drinks from baseline to the 4 month follow-up in the Alcohol+Coping Arm versus the Control Arm.||||.03
72459467|NCT03884478|144441676|OTHER||Mean Difference (Final Values)|0.46|STANDARD_ERROR_OF_MEAN|0.24||0.059|TWO_SIDED||||||Mixed Models Analysis|||As detailed in the statistical analysis plan, a multi-level model which held constant participant age, race, ethnicity, relationship status, sexual identity, and sexual minority interpersonal stigma exposure in examining Time\*Arm interactions on peak drinks. To probe the significant Alcohol+Control Arm\*Time interaction, a Tukey post-hoc test examined the change in weekly drinks from baseline to the 4 month follow-up in the Alcohol+Control Arm versus the Control Arm.||||.059
72459468|NCT03884478|144441676|OTHER||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.26||0.71|TWO_SIDED||||||Mixed Models Analysis|||As detailed in the statistical analysis plan, a multi-level model which held constant participant age, race, ethnicity, relationship status, sexual identity, and sexual minority interpersonal stigma exposure in examining Time\*Arm interactions on weekly drinks. To probe the significant Alcohol+Coping Arm\*Time interaction, a Tukey post-hoc test examined the change in peak drinks from baseline to the 4 month follow-up in the Alcohol+Coping Arm versus the Alcohol+Control Arm.||||.71
72459469|NCT03884478|144441677|OTHER||Mean Difference (Final Values)|0.86|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED||||||Mixed Models Analysis|||As detailed in the statistical analysis plan, a multi-level model which held constant participant age, race, ethnicity, relationship status, sexual identity, and sexual minority interpersonal stigma exposure in examining Time\*Arm interactions on negative consequences. To probe the significant Alcohol+Coping Arm\*Time interaction, a Tukey post-hoc test examined the change in negative consequences from baseline to the 2 month follow-up in the Alcohol+Coping Arm versus the Control Arm.||||<.001
72470105|NCT02783573|144464446|SUPERIORITY||LS Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.01||0.93|TWO_SIDED|95.0|-0.015|0.017|||ANCOVA|||||0.017|-0.015|0.930
72563214|NCT00442546|144658160|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.024|STANDARD_ERROR_OF_MEAN|0.356||0.9466||95.0|-0.678|0.726|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET||0.726|-0.678|0.9466
72563215|NCT00442546|144658160|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.424|STANDARD_ERROR_OF_MEAN|0.621||0.4967||95.0|-1.66|0.812|||ANOVA||Mean difference (final values) = Least squares mean difference|Month 3||0.812|-1.660|0.4967
72459470|NCT03884478|144441677|OTHER||Mean Difference (Final Values)|0.83|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED||||||Mixed Models Analysis|||As detailed in the statistical analysis plan, a multi-level model which held constant participant age, race, ethnicity, relationship status, sexual identity, and sexual minority interpersonal stigma exposure in examining Time\*Arm interactions on negative consequences. To probe the significant Alcohol+Control Arm\*Time interaction, a Tukey post-hoc test examined the change in negative consequences from baseline to the 2 month follow-up in the Alcohol+Control Arm versus the Control Arm.||||<.001
72459471|NCT03884478|144441677|OTHER||Mean Difference (Final Values)|0.03|STANDARD_ERROR_OF_MEAN|0.19||0.87|TWO_SIDED||||||Mixed Models Analysis|||As detailed in the statistical analysis plan, a multi-level model which held constant participant age, race, ethnicity, relationship status, sexual identity, and sexual minority interpersonal stigma exposure in examining Time\*Arm interactions on negative consequences. To probe the significant Alcohol+Coping Arm\*Time interaction, a Tukey post-hoc test examined the change in negative consequences from baseline to the 2 month follow-up in the Alcohol+Coping Arm versus the Alcohol+Control Arm.||||.87
72459472|NCT03884478|144441678|OTHER||Median Difference (Final Values)|0.86|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED||||||Mixed Models Analysis|||As detailed in the statistical analysis plan, a multi-level model which held constant participant age, race, ethnicity, relationship status, sexual identity, and sexual minority interpersonal stigma exposure in examining Time\*Arm interactions on negative consequences. To probe the significant Alcohol+Coping Arm\*Time interaction, a Tukey post-hoc test examined the change in negative consequences from baseline to the 4 month follow-up in the Alcohol+Coping Arm versus the Control Arm.||||<.001
72459473|NCT03884478|144441678|OTHER||Mean Difference (Final Values)|0.7|STANDARD_ERROR_OF_MEAN|0.19||0.002|TWO_SIDED||||||Mixed Models Analysis|||As detailed in the statistical analysis plan, a multi-level model which held constant participant age, race, ethnicity, relationship status, sexual identity, and sexual minority interpersonal stigma exposure in examining Time\*Arm interactions on negative consequences. To probe the significant Alcohol+Control Arm\*Time interaction, a Tukey post-hoc test examined the change in negative consequences from baseline to the 4 month follow-up in the Alcohol+Control Arm versus the Control Arm.||||.002
72459474|NCT03884478|144441678|OTHER||Mean Difference (Final Values)|0.15|STANDARD_ERROR_OF_MEAN|0.2||0.43|TWO_SIDED||||||Mixed Models Analysis|||As detailed in the statistical analysis plan, a multi-level model which held constant participant age, race, ethnicity, relationship status, sexual identity, and sexual minority interpersonal stigma exposure in examining Time\*Arm interactions on negative consequences. To probe the significant Alcohol+Coping Arm\*Time interaction, a Tukey post-hoc test examined the change in negative consequences from baseline to the 4 month follow-up in the Alcohol+Coping Arm versus the Alcohol+Control Arm.||||.43
72459475|NCT04454125|144441680|SUPERIORITY||Odds Ratio (OR)|0.61||||0.32|TWO_SIDED|95.0|0.23|1.61|||Generalized linear model, repeat measure|Generalized linear model (GLM) fitted with binomial distribution and logit link|Estimate is for the control group (Routine Care) obtained from generalized linear model with repeat measures including group arm, visit, interaction term (arm\*visit) and adjusting for visit 2 severe asthma exacerbation.|Outcome= severe asthma exacerbation at visit (yes, no), collected via questionnaire at visits 2-7(exit). Does not include randomization (visit 1).||1.61|0.23|0.32
72459476|NCT04454125|144441680|SUPERIORITY||Odds Ratio (OR)|0.31||||0.29|TWO_SIDED|95.0|0.03|2.76|||generalized linear model, repeat measure|GLM fitted with binomial distribution and logit link|Estimate is for the intervention group (AQI intervention) obtained from generalized linear model with repeat measures including group, visit, interaction term (group\*visit) and adjusting for visit 2 severe asthma exacerbation.|Outcome= severe asthma exacerbation at visit (yes, no), collected via questionnaire at visits 2-7(exit). Does not include randomization (visit 1).||2.76|0.03|0.29
72459477|NCT04454125|144441680|SUPERIORITY||Odds Ratio (OR)|0.51||||0.58|TWO_SIDED|95.0|0.05|5.68|||generalized linear model, repeat measure|GLM fitted with binomial distribution and logit link||Outcome= severe asthma exacerbation at visit (yes, no), collected via questionnaire at visits 2-7(exit). Does not include randomization (visit 1).|Estimate is for the interaction term (group\*visit) obtained from generalized linear model with repeat measures including group, visit, interaction term (group\*visit) and adjusting for visit 2 severe asthma exacerbation.|5.68|0.05|0.58
72470106|NCT02783573|144464447|SUPERIORITY||LS Mean Difference (Final Values)|-1.62|STANDARD_ERROR_OF_MEAN|1.06||0.127|TWO_SIDED|95.0|-3.708|0.464|||ANCOVA|||||0.464|-3.708|0.127
72470107|NCT02783573|144464447|SUPERIORITY||LS Mean Difference (Final Values)|-3.08|STANDARD_ERROR_OF_MEAN|1.06||0.004|TWO_SIDED|95.0|-5.172|-0.991|||ANCOVA|||||-0.991|-5.172|0.004
72470108|NCT00581893|144464450|SUPERIORITY|||||||0.5|||||||McNemar|||||||0.50
72470109|NCT00233480|144464451|SUPERIORITY_OR_OTHER_LEGACY|||||||0.025|TWO_SIDED|95.0|||||paired t test|||||||0.025
72470110|NCT00159263|144464457|OTHER|Friedman ANOVA followed Dunn's pairwise comparisons||||||0.04|||||||ANOVA|||||||0.04
72470111|NCT00159263|144464458|OTHER|Friedman Anova||||||0.01|||||||ANOVA|||||||0.01
72563216|NCT00442546|144658160|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.099|STANDARD_ERROR_OF_MEAN|0.582||0.8659||95.0|-1.06|1.257|||ANOVA||Mean difference (final values) = Least squares mean difference|Month 3||1.257|-1.060|0.8659
72470112|NCT00159263|144464459|OTHER|Friedman Anova||||||0.04|||||||ANOVA|||||||0.04
72470113|NCT01012245|144464460|SUPERIORITY_OR_OTHER_LEGACY||Mean value|17.2|STANDARD_DEVIATION|3.4||||95.0|17.2|17.3||||||IOP 1 year (n=11602)||17.3|17.2|
72563217|NCT00442546|144658160|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.994|STANDARD_ERROR_OF_MEAN|0.451||0.0311||95.0|0.093|1.895|||ANOVA||Mean difference (final values) = Least squares mean difference|Month 6||1.895|0.093|0.0311
72563218|NCT00442546|144658160|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.995|STANDARD_ERROR_OF_MEAN|0.485||0.0441||95.0|0.027|1.962|||ANOVA||Mean difference (final values) = Least squares mean difference|Month 6||1.962|0.027|0.0441
72563219|NCT00442546|144658161|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.969|STANDARD_ERROR_OF_MEAN|0.439||0.0284||95.0|-1.835|-0.104|||ANOVA||Mean difference (final values) = Least squares mean difference|Discharge||-0.104|-1.835|0.0284
72392492|NCT01652703|144292425|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-52.85|STANDARD_ERROR_OF_MEAN|3.03|<|0.001|TWO_SIDED|95.0|-58.84|-46.86||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factor of screening LDL-C level.|Placebo is the reference|The null hypothesis was that there was no mean difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.||-46.86|-58.84|<0.001
72392493|NCT01652703|144292425|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-63.94|STANDARD_ERROR_OF_MEAN|3.18|<|0.001|TWO_SIDED|95.0|-70.23|-57.66||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factor of screening LDL-C level.|Placebo is the reference|The null hypothesis was that there was no mean difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.||-57.66|-70.23|<0.001
72392494|NCT01652703|144292425|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-58.16|STANDARD_ERROR_OF_MEAN|3.21|<|0.001|TWO_SIDED|95.0|-64.51|-51.81||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factor of screening LDL-C level.|Placebo is the reference|The null hypothesis was that there was no mean difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.||-51.81|-64.51|<0.001
72392495|NCT01652703|144292426|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-96.3|STANDARD_ERROR_OF_MEAN|4.9|<|0.001|TWO_SIDED|95.0|-106.0|-86.5||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factor of screening LDL-C level.|Placebo is the reference|||-86.5|-106.0|<0.001
72392496|NCT01652703|144292426|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-75.5|STANDARD_ERROR_OF_MEAN|5.0|<|0.001|TWO_SIDED|95.0|-85.4|-65.5||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factor of screening LDL-C level.|Placebo is the reference|||-65.5|-85.4|<0.001
72392497|NCT01652703|144292426|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-88.2|STANDARD_ERROR_OF_MEAN|4.7|<|0.001|TWO_SIDED|95.0|-97.4|-79.0||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factor of screening LDL-C level.|Placebo is the reference|||-79.0|-97.4|<0.001
72459478|NCT04454125|144441680|SUPERIORITY||Odds Ratio (OR)|0.5||||0.02|TWO_SIDED|95.0|0.27|0.91|||generalized linear model, repeat measure|GLM fitted with binomial distribution and logit link|Estimate is for the control group (Routine Care) obtained from generalized linear model with repeat measures including group, visit, interaction term (group\*visit) and adjusting for visit 2 moderate asthma exacerbation.|Outcome= moderate asthma exacerbation at visit (yes, no), collected via questionnaire at visits 2-7(exit). Does not include randomization (visit 1).||0.91|0.27|0.02
72459479|NCT04454125|144441680|SUPERIORITY||Odds Ratio (OR)|0.23||||0.03|TWO_SIDED|95.0|0.06|0.86|||generalized linear model, repeat measure|GLM fitted with binomial distribution and logit link|Estimate is for the intervention group (AQI Intervention) obtained from generalized linear model with repeat measures including group, visit, interaction term (group\*visit) and adjusting for visit 2 moderate asthma exacerbation.|Outcome= moderate asthma exacerbation at visit (yes, no), collected via questionnaire at visits 2-7(exit). Does not include randomization (visit 1).||0.86|0.06|0.03
72470114|NCT01012245|144464460|SUPERIORITY_OR_OTHER_LEGACY||Mean value|16.9|STANDARD_DEVIATION|2.9||||95.0|16.8|17.0||||||IOP 1 year (n=4450)||17.0|16.8|
72470115|NCT01012245|144464460|SUPERIORITY_OR_OTHER_LEGACY||Mean value|17.3|STANDARD_DEVIATION|2.2||||95.0|17.1|17.5||||||IOP 1 year (n=357)||17.5|17.1|
72470116|NCT01012245|144464460|SUPERIORITY_OR_OTHER_LEGACY||Mean value|16.9|STANDARD_DEVIATION|3.2||||95.0|16.4|17.3||||||IOP 1 year (n=220)||17.3|16.4|
72392498|NCT01652703|144292426|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-80.7|STANDARD_ERROR_OF_MEAN|4.7|<|0.001|TWO_SIDED|95.0|-90.0|-71.4||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factor of screening LDL-C level.|Placebo is the reference|||-71.4|-90.0|<0.001
72392499|NCT01652703|144292427|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1945.68|||<|0.001|TWO_SIDED|95.0|89.64|42232.63||Testing based on a significance level of 0.05.|Regression, Logistic|Logistic Regression model includes treatment arms in dose frequency of Q2W and stratification factor of screening LDL-C level.|Placebo is the reference|||42232.63|89.64|<0.001
72392500|NCT01652703|144292427|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|281.13|||<|0.001|TWO_SIDED|95.0|14.74|5360.92||Testing based on a significance level of 0.05.|Regression, Logistic|Logistic Regression model includes treatment arms in dose frequency of Q2W and stratification factor of screening LDL-C level.|Placebo is the reference|||5360.92|14.74|<0.001
72392501|NCT01652703|144292427|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|536.45|||<|0.001|TWO_SIDED|95.0|28.37|10143.4||Testing based on a significance level of 0.05.|Regression, Logistic|Logistic Regression model includes treatment arms in dose frequency of Q4W and stratification factor of screening LDL-C level.|Placebo is the reference|||10143.40|28.37|<0.001
72392502|NCT01652703|144292427|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|595.59|||<|0.001|TWO_SIDED|95.0|31.11|11402.67||Testing based on a significance level of 0.05.|Regression, Logistic|Logistic Regression model includes treatment arms in dose frequency of Q4W and stratification factor of screening LDL-C level.|Placebo is the reference|||11402.67|31.11|<0.001
72470117|NCT01012245|144464460|SUPERIORITY_OR_OTHER_LEGACY||Mean value|17.6|STANDARD_DEVIATION|4.1||||95.0|17.5|17.8||||||IOP 1 year (n=3277)||17.8|17.5|
72470118|NCT01012245|144464460|SUPERIORITY_OR_OTHER_LEGACY||Mean value|17.0|STANDARD_DEVIATION|3.4||||95.0|17.0|17.1||||||IOP 2 years (n=8051)||17.1|17.0|
72470119|NCT01012245|144464460|SUPERIORITY_OR_OTHER_LEGACY||Mean value|16.8|STANDARD_DEVIATION|2.9||||95.0|16.7|16.9||||||IOP 2 years (n=2808)||16.9|16.7|
72470120|NCT01012245|144464460|SUPERIORITY_OR_OTHER_LEGACY||Mean value|17.2|STANDARD_DEVIATION|1.8||||95.0|17.0|17.5||||||IOP 2 years (n=175)||17.5|17.0|
72470121|NCT01012245|144464460|SUPERIORITY_OR_OTHER_LEGACY||Mean value|16.6|STANDARD_DEVIATION|2.8||||95.0|15.9|17.2||||||IOP 2 years (n=83)||17.2|15.9|
72470122|NCT01012245|144464460|SUPERIORITY_OR_OTHER_LEGACY||Mean value|17.1|STANDARD_DEVIATION|3.7||||95.0|16.9|17.2||||||IOP 2 years (n=2002)||17.2|16.9|
72470123|NCT01012245|144464460|SUPERIORITY_OR_OTHER_LEGACY||Mean value|17.0|STANDARD_DEVIATION|3.4||||95.0|16.9|17.1||||||IOP 3 years (n=5469)||17.1|16.9|
72459480|NCT04454125|144441680|SUPERIORITY||Odds Ratio (OR)|0.47||||0.3|TWO_SIDED|95.0|0.11|1.95|||generalized linear model, repeat measure|GLM fitted with binomial distribution and logit link|Estimate is for the interaction term (group\*visit) obtained from generalized linear model with repeat measures including group, visit, interaction term (group\*visit) and adjusting for visit 2 moderate asthma exacerbation.|Outcome= moderate asthma exacerbation at visit (yes, no), collected via questionnaire at visits 2-7(exit). Does not include randomization (visit 1).||1.95|0.11|0.30
72563220|NCT00442546|144658161|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.265|STANDARD_ERROR_OF_MEAN|0.444||0.5516||95.0|-1.141|0.611|||ANOVA||Mean difference (final values) = Least squares mean difference|Discharge||0.611|-1.141|0.5516
72459481|NCT04454125|144441681|SUPERIORITY||Mean Difference (Net)|0.17||||0.8|TWO_SIDED|95.0|-1.17|1.51|||generalized linear model, repeat measure|GLM fitted with Normal/Gaussian distribution and identity link|Estimate is for the control group (Routine Care) obtained from generalized linear model with repeat measures including group, visit, interaction term (group\*visit).|Outcome=Asthma Control Test Score. Obtained at all visits.||1.51|-1.17|0.80
72459482|NCT04454125|144441681|SUPERIORITY||Mean Difference (Net)|2.02||||0.001|TWO_SIDED|95.0|0.88|3.15|||generalized linear model, repeat measure|GLM fitted with Normal/Gaussian distribution and identity link|Estimate is for the intervention group (AQI Intervention) obtained from generalized linear model with repeat measures including group, visit, interaction term (group\*visit).|Outcome=Asthma Control Test Score. Obtained at all visits.||3.15|0.88|0.001
72459483|NCT04454125|144441681|SUPERIORITY||Mean Difference (Net)|1.85||||0.04|TWO_SIDED|95.0|0.09|3.61|||generalized linear model, repeat measure|GLM fitted with Normal/Gaussian distribution and identity link|Estimate is for the interaction term (group\*visit) obtained from generalized linear model with repeat measures including group, visit, interaction term (group\*visit).|Outcome=Asthma Control Test Score. Obtained at all visits.||3.61|0.09|0.04
72459484|NCT04454125|144441681|SUPERIORITY||Mean Difference (Net)|-0.31||||0.7|TWO_SIDED|95.0|-1.87|1.25|||generalized linear model, repeat measure|GLM fitted with Normal/Gaussian distribution and identity link|Estimate is for the control group (Routine Care) obtained from generalized linear model with repeat measures including group, visit, interaction term (group\*visit).|Outcome=Childhood Asthma Control Test Score. Obtained at all visits.||1.25|-1.87|0.70
72459485|NCT04454125|144441681|SUPERIORITY||Mean Difference (Net)|3.96||||0.14|TWO_SIDED|95.0|-1.27|9.2|||generalized linear model, repeat measure|GLM fitted with Normal/Gaussian distribution and identity link|Estimate is for the intervention group (AQI Intervention) obtained from generalized linear model with repeat measures including group, visit, interaction term (group\*visit).|Outcome=Childhood Asthma Control Test Score. Obtained at all visits.||9.20|-1.27|0.14
72563221|NCT00442546|144658161|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.27|STANDARD_ERROR_OF_MEAN|0.38||0.479||95.0|-1.02|0.48|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2||0.480|-1.020|0.4790
72563222|NCT00442546|144658161|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.003|STANDARD_ERROR_OF_MEAN|0.39||0.9947||95.0|-0.765|0.77|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2||0.770|-0.765|0.9947
72563223|NCT00442546|144658161|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.044|STANDARD_ERROR_OF_MEAN|0.329||0.8943||95.0|-0.605|0.692|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4||0.692|-0.605|0.8943
72459486|NCT04454125|144441681|SUPERIORITY||Mean Difference (Net)|4.27||||0.13|TWO_SIDED|95.0|-1.19|9.73|||generalized linear model, repeat measure|GLM fitted with Normal/Gaussian distribution and identity link|Estimate is for the interaction term (group\*visit) obtained from generalized linear model with repeat measures including group, visit, interaction term (group\*visit).|Outcome=Childhood Asthma Control Test Scores.||9.73|-1.19|0.13
72459487|NCT04454125|144441682|SUPERIORITY||Mean Difference (Net)|0.25||||0.11|TWO_SIDED|95.0|-0.06|0.55|||generalized linear model, repeat measure|GLM fitted with Normal/Gaussian distribution and identity link|Estimate is for the control group (Routine Care) obtained from generalized linear model with repeat measures including group, visit, interaction term (group\*visit).|Outcome: Pediatric Asthma Quality of Life Questionnaire. Obtained at randomization and exit visits (visit 1 and visit 7).||0.55|-0.06|0.11
72459488|NCT04454125|144441682|SUPERIORITY||Mean Difference (Net)|0.54||||0.002|TWO_SIDED|95.0|0.2|0.88|||generalized linear model, repeat measure|GLM fitted with Normal/Gaussian distribution and identity link|Estimate is for the intervention group (AQI Intervention) obtained from generalized linear model with repeat measures including group, visit, interaction term (group\*visit).|Outcome: Pediatric Asthma Quality of Life Questionnaire. Obtained at randomization and exit visits (visit 1 and visit 7).||0.88|0.20|0.002
72370519|NCT00488683|144251632|SUPERIORITY_OR_OTHER||R-square|0.0027||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one month after booster vaccination for the serogroup A||||
72470124|NCT01012245|144464460|SUPERIORITY_OR_OTHER_LEGACY||Mean value|16.8|STANDARD_DEVIATION|3.2||||95.0|16.7|17.0||||||IOP 3 years (n=1932)||17.0|16.7|
72470125|NCT01012245|144464460|SUPERIORITY_OR_OTHER_LEGACY||Mean value|17.5|STANDARD_DEVIATION|2.5||||95.0|16.9|18.1||||||IOP 3 years (n=64)||18.1|16.9|
72470126|NCT01012245|144464460|SUPERIORITY_OR_OTHER_LEGACY||Mean value|16.5|STANDARD_DEVIATION|2.8||||95.0|15.7|17.4||||||IOP 3 years (n=44)||17.4|15.7|
72470127|NCT01012245|144464460|SUPERIORITY_OR_OTHER_LEGACY||Mean value|16.9|STANDARD_DEVIATION|3.6||||95.0|16.7|17.1||||||IOP 3 years (n=1251)||17.1|16.7|
72470128|NCT01012245|144464462|SUPERIORITY_OR_OTHER_LEGACY||Mean value|0.46|STANDARD_DEVIATION|0.25||||95.0|0.46|0.47||||||Vertical C/D ratio 1 year (n=11966)||0.47|0.46|
72470129|NCT01012245|144464462|SUPERIORITY_OR_OTHER_LEGACY||Mean value|0.44|STANDARD_DEVIATION|0.24||||95.0|0.43|0.44||||||Vertical C/D ratio 1 year (n=4944)||0.44|0.43|
72470130|NCT01012245|144464462|SUPERIORITY_OR_OTHER_LEGACY||Mean value|0.39|STANDARD_DEVIATION|0.19||||95.0|0.35|0.43||||||Vertical C/D ratio 1 year (n=88)||0.43|0.35|
72470131|NCT01012245|144464462|SUPERIORITY_OR_OTHER_LEGACY||Mean value|0.5|STANDARD_DEVIATION|0.24||||95.0|0.47|0.53||||||Vertical C/D ratio 1 year (n=241)||0.53|0.47|
72470132|NCT01012245|144464462|SUPERIORITY_OR_OTHER_LEGACY||Mean value|0.51|STANDARD_DEVIATION|0.27||||95.0|0.5|0.52||||||Vertical C/D ratio 1 year (n=2949)||0.52|0.50|
72470133|NCT01012245|144464462|SUPERIORITY_OR_OTHER_LEGACY||Mean value|0.46|STANDARD_DEVIATION|0.25||||95.0|0.46|0.47||||||Vertical C/D ratio 2 years (n=8783)||0.47|0.46|
72620938|NCT00452400|144772839|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.231|STANDARD_ERROR_OF_MEAN|0.032|<|0.0001||95.0|0.169|0.294|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 5 mcg qd minus Placebo|||0.294|0.169|<0.0001
72620939|NCT00452400|144772839|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.233|STANDARD_ERROR_OF_MEAN|0.031|<|0.0001||95.0|0.172|0.295|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 10 mcg qd minus Placebo|||0.295|0.172|<0.0001
72620940|NCT00452400|144772839|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.259|STANDARD_ERROR_OF_MEAN|0.032|<|0.0001||95.0|0.197|0.322|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 20 mcg qd minus Placebo|||0.322|0.197|<0.0001
72620941|NCT00452400|144772840|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.165|STANDARD_ERROR_OF_MEAN|0.032|<|0.0001||95.0|0.101|0.228|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 2 mcg qd minus Placebo|||0.228|0.101|<0.0001
72620942|NCT00452400|144772840|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.189|STANDARD_ERROR_OF_MEAN|0.032|<|0.0001||95.0|0.125|0.252|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 5 mcg qd minus Placebo|||0.252|0.125|<0.0001
72392503|NCT01652703|144292428|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-62.56|STANDARD_ERROR_OF_MEAN|2.68|<|0.001|TWO_SIDED|95.0|-67.85|-57.27||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factor of screening LDL-C level.|Placebo is the reference|||-57.27|-67.85|<0.001
72392504|NCT01652703|144292428|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-49.46|STANDARD_ERROR_OF_MEAN|2.72|<|0.001|TWO_SIDED|95.0|-54.83|-44.08||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factor of screening LDL-C level.|Placebo is the reference|||-44.08|-54.83|<0.001
72392505|NCT01652703|144292428|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-58.08|STANDARD_ERROR_OF_MEAN|2.96|<|0.001|TWO_SIDED|95.0|-63.93|-52.22||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factor of screening LDL-C level.|Placebo is the reference|||-52.22|-63.93|<0.001
72392506|NCT01652703|144292428|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-53.54|STANDARD_ERROR_OF_MEAN|2.99|<|0.001|TWO_SIDED|95.0|-59.46|-47.63||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factor of screening LDL-C level.|Placebo is the reference|||-47.63|-59.46|<0.001
72392507|NCT01652703|144292429|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-60.69|STANDARD_ERROR_OF_MEAN|2.52|<|0.001|TWO_SIDED|95.0|-65.67|-55.72||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factor of screening LDL-C level.|Placebo is the reference|||-55.72|-65.67|<0.001
72459489|NCT04454125|144441682|SUPERIORITY||Mean Difference (Net)|0.3||||0.2|TWO_SIDED|95.0|-0.16|0.75|||generalized linear model, repeat measure|GLM fitted with Normal/Gaussian distribution and identity link|Estimate is for the interaction term (group\*visit) obtained from generalized linear model with repeat measures including group, visit, interaction term (group\*visit).|Outcome: Pediatric Asthma Quality of Life Questionnaire. Obtained at randomization and exit visits (visit 1 and visit 7).||0.75|-0.16|0.20
72459490|NCT04454125|144441683|SUPERIORITY||Odds Ratio (OR)|0.94||||0.87|TWO_SIDED|95.0|0.45|1.96|||generalized linear model, repeat measure|GLM fitted with binomial distribution and logit link|Estimate is control group (Routine Care) obtained from generalized linear model with repeat measures including group, visit, interaction term (group\*visit).|Outcome: Reported checking the AQI prior to going outside to be active||1.96|0.45|0.87
72459491|NCT04454125|144441683|SUPERIORITY||Odds Ratio (OR)|6.89||||0.004|TWO_SIDED|95.0|1.85|25.6|||generalized linear model, repeat measure|GLM fitted with binomial distribution and logit link|Estimate is for the intervention group (AQI Intervention) obtained from generalized linear model with repeat measures including group, visit, interaction term (group\*visit).|Outcome: Reported checking the AQI prior to going outside to be active||25.6|1.85|0.004
72620943|NCT00452400|144772840|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.203|STANDARD_ERROR_OF_MEAN|0.032|<|0.0001||95.0|0.14|0.266|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 10 mcg qd minus Placebo|||0.266|0.140|<0.0001
72620944|NCT00452400|144772840|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.201|STANDARD_ERROR_OF_MEAN|0.033|<|0.0001||95.0|0.137|0.265|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 20 mcg qd minus Placebo|||0.265|0.137|<0.0001
72470134|NCT01012245|144464462|SUPERIORITY_OR_OTHER_LEGACY||Mean value|0.43|STANDARD_DEVIATION|0.23||||95.0|0.42|0.44||||||Vertical C/D ratio 2 years (n=3396)||0.44|0.42|
72620945|NCT00452400|144772841|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.045|STANDARD_ERROR_OF_MEAN|0.039||0.2392||95.0|-0.03|0.121|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 2 mcg qd minus Placebo|||0.121|-0.030|0.2392
72620946|NCT00452400|144772841|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.147|STANDARD_ERROR_OF_MEAN|0.038||0.0001||95.0|0.072|0.222|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 5 mcg qd minus Placebo|||0.222|0.072|0.0001
72620947|NCT00452400|144772841|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.176|STANDARD_ERROR_OF_MEAN|0.039|<|0.0001||95.0|0.099|0.253|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 10 mcg qd minus Placebo|||0.253|0.099|<0.0001
72620948|NCT00452400|144772841|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.152|STANDARD_ERROR_OF_MEAN|0.039||0.0001||95.0|0.076|0.228|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 20 mcg qd minus Placebo|||0.228|0.076|0.0001
72620949|NCT00452400|144772842|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.085|STANDARD_ERROR_OF_MEAN|0.039||0.0309||95.0|0.008|0.162|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 2 mcg qd minus Placebo|||0.162|0.008|0.0309
72620950|NCT00452400|144772842|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.174|STANDARD_ERROR_OF_MEAN|0.039|<|0.0001||95.0|0.098|0.25|||ANCOVA||Olo 2 mcg qd minus Placebo|||0.250|0.098|<0.0001
72563224|NCT00442546|144658161|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.336||0.9767||95.0|-0.674|0.654|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4||0.654|-0.674|0.9767
72563225|NCT00442546|144658161|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.081|STANDARD_ERROR_OF_MEAN|0.34||0.8117||95.0|-0.59|0.752|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET||0.752|-0.590|0.8117
72563226|NCT00442546|144658161|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.125|STANDARD_ERROR_OF_MEAN|0.351||0.7216||95.0|-0.818|0.567|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET||0.567|-0.818|0.7216
72563227|NCT00442546|144658161|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.108|STANDARD_ERROR_OF_MEAN|0.592||0.8558||95.0|-1.286|1.07|||ANOVA||Mean difference (final values) = Least squares mean difference|Month 3||1.070|-1.286|0.8558
72563228|NCT00442546|144658161|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.422|STANDARD_ERROR_OF_MEAN|0.556||0.4501||95.0|-1.53|0.685|||ANOVA||Mean difference (final values) = Least squares mean difference|Month 3||0.685|-1.530|0.4501
72563229|NCT00442546|144658161|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.328|STANDARD_ERROR_OF_MEAN|0.45||0.4682||95.0|-0.57|1.227|||ANOVA||Mean difference (final values) = Least squares mean difference|Month 6||1.227|-0.570|0.4682
72563230|NCT00442546|144658161|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.307|STANDARD_ERROR_OF_MEAN|0.492||0.5347||95.0|-0.675|1.289|||ANOVA||Mean difference (final values) = Least squares mean difference|Month 6||1.289|-0.675|0.5347
72563231|NCT00442546|144658162|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.765|STANDARD_ERROR_OF_MEAN|0.407||0.0613||95.0|-1.568|0.037|||ANOVA||Mean difference (final values) = Least squares mean difference|Discharge||0.037|-1.568|0.0613
72563232|NCT00442546|144658162|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.936|STANDARD_ERROR_OF_MEAN|0.409||0.023||95.0|-1.741|-0.13|||ANOVA||Mean difference (final values) = Least squares mean difference|Discharge||-0.130|-1.741|0.0230
72563233|NCT00442546|144658162|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.086|STANDARD_ERROR_OF_MEAN|0.4||0.8306||95.0|-0.703|0.875|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2||0.875|-0.703|0.8306
72620951|NCT00452400|144772842|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.15|STANDARD_ERROR_OF_MEAN|0.04||0.0002||95.0|0.072|0.228|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 10 mcg qd minus Placebo|||0.228|0.072|0.0002
72620952|NCT00452400|144772842|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.137|STANDARD_ERROR_OF_MEAN|0.039||0.0006||95.0|0.059|0.214|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 20 mcg qd minus Placebo|||0.214|0.059|0.0006
72470135|NCT01012245|144464462|SUPERIORITY_OR_OTHER_LEGACY||Mean value|0.39|STANDARD_DEVIATION|0.16||||95.0|0.33|0.45||||||Vertical C/D ratio 2 years (n=31)||0.45|0.33|
72470136|NCT01012245|144464462|SUPERIORITY_OR_OTHER_LEGACY||Mean value|0.49|STANDARD_DEVIATION|0.24||||95.0|0.44|0.54||||||Vertical C/D ratio 2 years (n=95)||0.54|0.44|
72563234|NCT00442546|144658162|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.439|STANDARD_ERROR_OF_MEAN|0.407||0.2814||95.0|-1.242|0.363|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2||0.363|-1.242|0.2814
72620953|NCT00452400|144772843|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.053|STANDARD_ERROR_OF_MEAN|0.043||0.215||95.0|-0.031|0.137|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 2 mcg qd minus Placebo|||0.137|-0.031|0.2150
72620954|NCT00452400|144772843|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.129|STANDARD_ERROR_OF_MEAN|0.042||0.0024||95.0|0.046|0.212|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 5 mcg qd minus Placebo|||0.212|0.046|0.0024
72370520|NCT00488683|144251632|SUPERIORITY_OR_OTHER||R-square|0.0002||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one month after booster vaccination for the serogroup C||||
72470137|NCT01012245|144464462|SUPERIORITY_OR_OTHER_LEGACY||Mean value|0.51|STANDARD_DEVIATION|0.27||||95.0|0.5|0.53||||||Vertical C/D ratio 2 years (n=1934)||0.53|0.50|
72470138|NCT01012245|144464462|SUPERIORITY_OR_OTHER_LEGACY||Mean value|0.45|STANDARD_DEVIATION|0.24||||95.0|0.44|0.45||||||Vertical C/D ratio 3 years (n=6344)||0.45|0.44|
72470139|NCT01012245|144464462|SUPERIORITY_OR_OTHER_LEGACY||Mean value|0.42|STANDARD_DEVIATION|0.22||||95.0|0.41|0.43||||||Vertical C/D ratio 3 years (n=2372)||0.43|0.41|
72470140|NCT01012245|144464462|SUPERIORITY_OR_OTHER_LEGACY||Mean value|0.33|STANDARD_DEVIATION|0.14||||95.0|0.27|0.39||||||Vertical C/D ratio 3 years (n=25)||0.39|0.27|
72470141|NCT01012245|144464462|SUPERIORITY_OR_OTHER_LEGACY||Mean value|0.47|STANDARD_DEVIATION|0.18||||95.0|0.41|0.53||||||Vertical C/D ratio 3 years (n=36)||0.53|0.41|
72470142|NCT01012245|144464462|SUPERIORITY_OR_OTHER_LEGACY||Mean value|0.49|STANDARD_DEVIATION|0.26||||95.0|0.48|0.51||||||Vertical C/D ratio 3 years (n=1283)||0.51|0.48|
72470143|NCT01012245|144464463|SUPERIORITY_OR_OTHER_LEGACY||Mean value|0.45|STANDARD_DEVIATION|0.25||||95.0|0.45|0.46||||||Horizontal C/D ratio 1 year (n=11433)||0.46|0.45|
72470144|NCT01012245|144464463|SUPERIORITY_OR_OTHER_LEGACY||Mean value|0.42|STANDARD_DEVIATION|0.23||||95.0|0.42|0.43||||||Horizontal C/D ratio 1 year (n=4810)||0.43|0.42|
72470145|NCT01012245|144464463|SUPERIORITY_OR_OTHER_LEGACY||Mean value|0.37|STANDARD_DEVIATION|0.19||||95.0|0.33|0.42||||||Horizontal C/D ratio 1 year (n=87)||0.42|0.33|
72470146|NCT01012245|144464463|SUPERIORITY_OR_OTHER_LEGACY||Mean value|0.5|STANDARD_DEVIATION|0.25||||95.0|0.47|0.53||||||Horizontal C/D ratio 1 year (n=232)||0.53|0.47|
72470147|NCT01012245|144464463|SUPERIORITY_OR_OTHER_LEGACY||Mean value|0.51|STANDARD_DEVIATION|0.27||||95.0|0.5|0.52||||||Horizontal C/D ratio 1 year (n=2703)||0.52|0.50|
72470148|NCT01012245|144464463|SUPERIORITY_OR_OTHER_LEGACY||Mean value|0.45|STANDARD_DEVIATION|0.25||||95.0|0.44|0.45||||||Horizontal C/D ratio 2 years (n=8427)||0.45|0.44|
72470149|NCT01012245|144464463|SUPERIORITY_OR_OTHER_LEGACY||Mean value|0.41|STANDARD_DEVIATION|0.23||||95.0|0.4|0.42||||||Horizontal C/D ratio 2 years (n=3276)||0.42|0.40|
72470150|NCT01012245|144464463|SUPERIORITY_OR_OTHER_LEGACY||Mean value|0.38|STANDARD_DEVIATION|0.19||||95.0|0.31|0.45||||||Horizontal C/D ratio 2 years (n=31)||0.45|0.31|
72470151|NCT01012245|144464463|SUPERIORITY_OR_OTHER_LEGACY||Mean value|0.5|STANDARD_DEVIATION|0.25||||95.0|0.45|0.56||||||Horizontal C/D ratio 2 years (n=92)||0.56|0.45|
72392508|NCT01652703|144292429|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-46.75|STANDARD_ERROR_OF_MEAN|2.56|<|0.001|TWO_SIDED|95.0|-51.8|-41.7||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factor of screening LDL-C level.|Placebo is the reference|||-41.70|-51.80|<0.001
72459492|NCT04454125|144441683|SUPERIORITY||Odds Ratio (OR)|7.31||||0.01|TWO_SIDED|95.0|1.62|32.9|||generalized linear model, repeat measure|GLM fitted with binomial distribution and logit link|Estimate is for the interaction term (group\*visit) obtained from generalized linear model with repeat measures including group, visit, interaction term (group\*visit).|Outcome: Reported checking the AQI prior to going outside to be active||32.9|1.62|0.01
72459493|NCT04454125|144441684|SUPERIORITY||Odds Ratio (OR)|0.34||||0.15|TWO_SIDED|95.0|0.08|1.47|||generalized linear model, repeat measure|GLM fitted with binomial distribution and logit link|Estimate is for the control group (Routine Care) obtained from generalized linear model with repeat measures including group, visit, interaction term (group\*visit).|Outcome: Reported outdoor activity behavioral change in response to the AQI, obtained at all visits.||1.47|0.08|0.15
72459494|NCT04454125|144441684|SUPERIORITY||Odds Ratio (OR)|0.96||||0.94|TWO_SIDED|95.0|0.35|2.68|||generalized linear model, repeat measure|GLM fitted with binomial distribution and logit link|Estimate is for the intervention group (AQI Intervention) obtained from generalized linear model with repeat measures including group, visit, interaction term (group\*visit).|Outcome: Reported outdoor activity behavioral change in response to the AQI, obtained at all visits.||2.68|0.35|0.94
72459495|NCT04454125|144441684|SUPERIORITY||Odds Ratio (OR)|2.79||||0.26|TWO_SIDED|95.0|0.47|16.5|||generalized linear model, repeat measure|GLM fitted with binomial distribution and logit link|Estimate is for the interaction term (group\*visit) obtained from generalized linear model with repeat measures including group, visit, interaction term (group\*visit).|Outcome: Reported outdoor activity behavioral change in response to the AQI, obtained at all visits.||16.5|0.47|0.26
72459496|NCT04454125|144441685|SUPERIORITY||Odds Ratio (OR)|0.42||||0.004|TWO_SIDED|95.0|0.24|0.76|||generalized linear model, repeat measure|GLM fitted with binomial distribution and logit link|Estimate is for the control group (Routine Care) obtained from generalized linear model with repeat measures including group, visit, interaction term (group\*visit).|Obtained at all visits||0.76|0.24|0.004
72459497|NCT04454125|144441685|SUPERIORITY||Odds Ratio (OR)|0.13|||<|0.0001|TWO_SIDED|95.0|0.05|0.31|||generalized linear model, repeat measure|GLM fitted with binomial distribution and logit link|Estimate is for the intervention group (AQI Intervention) obtained from generalized linear model with repeat measures including group, visit, interaction term (group\*visit).|Obtained at all visits.||0.31|0.05|<0.0001
72459498|NCT04454125|144441685|SUPERIORITY||Odds Ratio (OR)|0.29||||0.03|TWO_SIDED|95.0|0.1|0.87|||generalized linear model, repeat measure|GLM fitted with binomial distribution and logit link|Estimate is for the interaction term (group\*visit) obtained from generalized linear model with repeat measures including group, visit, interaction term (group\*visit).|Obtained at all visits.||0.87|0.10|0.03
72459499|NCT02301299|144441686|OTHER|For power calculation, we assumed that the intervention would be almost fully implemented in May 2016 and the early hospital arrival would be observed until Dec 2017. Therefore, a post-intervention period would be 20 months. To have one-third of the study period as an intervention period, we planned to analyze five-year (60-month) data from January 2013 to December 2017.|||||<|0.0001|||||||Regression, Linear|Using the seasonally adjusted time series data, we conducted linear regression analysis for time series data in PROC AUTOREG.||The effect size was defined as the sum of expected slope change in monthly early hospital arrival rate over the standard deviation. Assuming an autocorrelation level of 0.3, both level and trend change effect size of 0.5 would be detectable at 90% power at a significance level of 0.05.|Using SAS PROC TIMESERIES, individual admission data were aggregated into monthly time series data to calculate a monthly early arrival rate. In this procedure, we also generated seasonally adjusted time series data to take into account a seasonal pattern. Using the seasonally adjusted time series data, we conducted linear regression analysis for time series data in PROC AUTOREG. The statistical hypothesis of the regression model was that there are a level change and a slope change after the intervention. In the regression model, we included a time variable to account for a natural trend prior to the intervention introduction (or in absence of the intervention). We assumed that the patient population was stable during the five-year period and no other factors than the intervention affected the outcome; no other potential confounding factors were not considered. A backward elimination was used to correct for autocorrelation. Maximum likelihood method was used to estimate parameters.|||<.0001
72459500|NCT02301299|144441687|OTHER|For power calculation, we assumed that the intervention would be almost fully implemented in May 2016 and the EMS use would be observed until Dec 2017. Therefore, a post-intervention period would be 20 months. To have one-third of the study period as an intervention period, we planned to analyze five-year (60-month) data from January 2013 to December 2017.|||||<|0.0001|||||||Regression, Linear|||The effect size was defined as the sum of expected slope change in monthly EMS use rate over the standard deviation. Assuming an autocorrelation level of 0.3, both level and trend change effect size of 0.5 would be detectable at 90% power at a significance level of 0.05. The effect size is measured in slope of change over time (negative values indicate a decrease while positive values indicate an increase in % EMS use/month).|Using SAS PROC TIMESERIES, individual admission data were aggregated into monthly time series data to calculate a monthly EMS arrival rate. In this procedure, we also generated seasonally adjusted time series data to take into account a seasonal pattern. Using the seasonally adjusted time series data, we conducted linear regression analysis for time series data in PROC AUTOREG. The statistical hypothesis of the regression model was that there are a level change and a slope change after the intervention. In the regression model, we included a time variable to account for a natural trend prior to the intervention introduction (or in absence of the intervention). We assumed that the patient population was stable during the five-year period and no other factors than the intervention affected the outcome; no other potential confounding factors were not considered. A backward elimination was used to correct for autocorrelation. Maximum likelihood method was used to estimate parameters.|||<.0001
72501030|NCT01381094|144532151|SUPERIORITY||||||=|0.0002|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 6).||||=0.0002
72459501|NCT03512041|144441689|SUPERIORITY|||||||0.172|||||||ANOVA|||||||0.172
72459502|NCT03512041|144441690|SUPERIORITY|||||||0.169|||||||ANOVA|||||||0.169
72459503|NCT03512041|144441691|SUPERIORITY|||||||0.501|||||||ANOVA|||||||0.501
72459504|NCT00828139|144441692|SUPERIORITY_OR_OTHER||3-month PFS|0.24|||||TWO_SIDED|90.0|0.14|0.37|||||The estimated value corresponds to the probability of PFS at month 3.|3-month PFS was estimated using the method of Kaplan-Meier. The 3-month PFS estimated value corresponds to the probability of PFS at month 3.||0.37|0.14|
72459505|NCT00828139|144441692|SUPERIORITY_OR_OTHER||3-month PFS|0.15|||||TWO_SIDED|90.0|0.07|0.27|||||The estimated value corresponds to the probability of PFS at month 3.|3-month PFS was estimated using the method of Kaplan-Meier.||0.27|0.07|
72459506|NCT00828139|144441692|SUPERIORITY_OR_OTHER||3-month PFS|0.27|||||TWO_SIDED|90.0|0.18|0.39|||||The estimated value corresponds to the probability of PFS at month 3.|3-month PFS was estimated using the method of Kaplan-Meier.||0.39|0.18|
72459507|NCT00828139|144441692|SUPERIORITY_OR_OTHER||3-month PFS|0.1|||||TWO_SIDED|90.0|0.04|0.2|||||The estimated value corresponds to the probability of PFS at month 3.|3-month PFS was estimated using the method of Kaplan-Meier.||0.2|0.04|
72459508|NCT00828139|144441692|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.32|||||TWO_SIDED|90.0|0.91|1.92||||||Hazard Ratio was evaluated using a logrank test.||1.92|0.91|
72459509|NCT00828139|144441692|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.51|||||TWO_SIDED|90.0|1.08|2.1||||||Hazard Ratio was evaluated using log-rank test.||2.10|1.08|
72459510|NCT01922102|144441722|SUPERIORITY_OR_OTHER||Mean Difference (Net)|5.2|||<|0.001|TWO_SIDED|95.0|3.3|7.1||Superiority could be claimed if the corresponding one-sided p-value was ≤ 0.025/2 = 0.0125, or if both one-sided p-values were ≤ 0.025.|Cochran-Mantel-Haenszel||Differences in LS means and the two-sided 95% CIs are estimated from pairwise ANOVA (stratified) model.|2 one-sided hypotheses were tested under the Type I error rate of 0.025, using the Hochberg procedure: H01: μRanibizumab-I - μvPDT ≤ 0 vs. HA1: μRanibizumab-I - μvPDT \> 0 and H02: μRanibizumab-II - μvPDT ≤ 0 vs. HA2: μRanibizumab-II - μvPDT \> 0, where μRanibizumab-I, μRanibizumab-II and μvPDT were the means of the primary efficacy variable for ranibizumab treatment Group I, ranibizumab treatment Group II, and vPDT treatment Group III, respectively.||7.1|3.3|<0.001
72459511|NCT01922102|144441722|SUPERIORITY_OR_OTHER||Mean Difference (Net)|5.6|||<|0.001|TWO_SIDED|95.0|3.5|7.6||Superiority could be claimed if the corresponding one-sided p-value was ≤ 0.025/2 = 0.0125, or if both one-sided p-values were ≤ 0.025.|Cochran-Mantel-Haenszel||Differences in LS means and the two-sided 95% CIs are estimated from pairwise ANOVA (stratified) model.|"The following 2 one-sided hypotheses were tested under the Type I error rate of 0.025, using the Hochberg procedure:~H01: μRanibizumab-I - μvPDT ≤ 0 vs. HA1: μRanibizumab-I - μvPDT \> 0 and H02: μRanibizumab-II - μvPDT ≤ 0 vs. HA2: μRanibizumab-II - μvPDT \> 0, where μRanibizumab-I, μRanibizumab-II and μvPDT were the means of the primary efficacy variable for ranibizumab treatment Group I, ranibizumab treatment Group II, and vPDT treatment Group III, respectively."||7.6|3.5|<0.001
72459512|NCT01922102|144441723|NON_INFERIORITY_OR_EQUIVALENCE|"one-sided hypotheses were tested under the Type I error rate of 0.025, if H01 and H02 were rejected: H03: μRanibizumab-II - μRanibizumab-I ≤ -5 vs. HA3: μRanibizumab-II - μRanibizumab-I \> -5.~Otherwise, H03 was not to be considered as rejected."|Mean Difference (Net)|0.4|||<|0.001|TWO_SIDED|95.0|-1.3|2.1||Non-inferiority could be claimed if the corresponding one-sided p-value was ≤ 0.025.|Cochran-Mantel-Haenszel||Differences in LS means and the two-sided 95% CIs are estimated from pairwise ANOVA (stratified) model.|||2.1|-1.3|<0.001
72459513|NCT00759681|144441736|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.208|STANDARD_ERROR_OF_MEAN|0.0538||0.05|TWO_SIDED|95.0|0.103|0.314|||Exact binomial confidence limit|Effectiveness: 95% confidence limits of the difference between groups, and ensuring that the lower limit of the difference was greater than 10%.||Effectiveness was evaluated using a superiority hypothesis, comparing treatment sites with regards to the proportion achieving immediate suture line sealing between the groups. Effectiveness was based on a two-tailed, 0.05 hypothesis test, with a minimum effect size set at 10%. The mean difference in the proportion of sites achieving immediate suture line sealing was compared between the Control and Investigation Device groups.||0.314|0.103|0.05
72459514|NCT00759681|144441737|NON_INFERIORITY_OR_EQUIVALENCE|Safety was evaluated using non-inferiority hypothesis evaluating the proportion of cases with any instance of sign. bleeding, neurological deficit or immune/inflammatory allergic response. Safety based on one-tailed, 0.05 alpha, with equivalence limit set at 15%.|Mean Difference (Final Values)|-0.135|STANDARD_ERROR_OF_MEAN|0.0671||0.05|ONE_SIDED|95.0||-0.003|||Exact binomial confidence limit|Safety: 95% confidence limits of the difference between groups, and ensuring that the upper limit of the difference was less than or equal to 15%.|The cumulative incidence of safety endpoints for the Investigational Treatment group was an average of 13.5% less than for the Control group.|The mean difference is equivalent to the proportion of Investigational Device patients minus the proportion of Control patients experiencing any instance of significant bleeding, neurological deficit or immune/inflammatory allergic response.||-0.003||0.05
72459515|NCT00476151|144441738|SUPERIORITY_OR_OTHER|||||||0.083|TWO_SIDED|95.0|||||ANCOVA|||||||0.083
72459516|NCT01383616|144441742|SUPERIORITY|||||||0.85|||||||t-test, 2 sided|||Comparison of 3 month ODI Score between Unipedicular and Bipedicular kyphoplasty groups||||0.85
72459517|NCT01383616|144441743|SUPERIORITY|||||||0.008|||||||t-test, 2 sided|||||||0.008
72459518|NCT01383616|144441744|SUPERIORITY|||||||0.17|||||||t-test, 2 sided|||||||0.17
72459519|NCT01383616|144441745|SUPERIORITY|||||||0.93|||||||t-test, 2 sided|||||||0.93
72459520|NCT01383616|144441746|SUPERIORITY|||||||0.17|||||||t-test, 2 sided|||||||0.17
72459521|NCT01383616|144441747|SUPERIORITY|||||||0.67|||||||t-test, 2 sided|||||||0.67
72459522|NCT01383616|144441748|SUPERIORITY|||||||0.9|||||||t-test, 2 sided|||||||0.90
72459523|NCT01383616|144441749|SUPERIORITY|||||||0.36|||||||t-test, 2 sided|||||||0.36
72459524|NCT01383616|144441750|SUPERIORITY|||||||0.87|||||||t-test, 2 sided|||||||0.87
72459525|NCT01383616|144441751|SUPERIORITY|||||||0.24|||||||t-test, 2 sided|||||||0.24
72470152|NCT01012245|144464463|SUPERIORITY_OR_OTHER_LEGACY||Mean value|0.51|STANDARD_DEVIATION|0.27||||95.0|0.49|0.52||||||Horizontal C/D ratio 2 years (n=1812)||0.52|0.49|
72470153|NCT01012245|144464463|SUPERIORITY_OR_OTHER_LEGACY||Mean value|0.43|STANDARD_DEVIATION|0.24||||95.0|0.43|0.44||||||Horizontal C/D ratio 3 years (n=6102)||0.44|0.43|
72470154|NCT01012245|144464463|SUPERIORITY_OR_OTHER_LEGACY||Mean value|0.4|STANDARD_DEVIATION|0.22||||95.0|0.39|0.41||||||Horizontal C/D ratio 3 years (n=2289)||0.41|0.39|
72459526|NCT05265247|144441771|EQUIVALENCE|The two formulations were considered to be bioequivalent if the point estimate for the ratio lies completely within the range of 0.8-1.25.|Ratio of Geometric least squares mean|0.9531|||||TWO_SIDED|90.0|0.851|1.0673||||||||1.0673|0.8510|
72459527|NCT05265247|144441772|EQUIVALENCE|The two formulations were considered to be bioequivalent if the 90% 2-sided confidence interval (CI) for the ratio lies completely within the range of 0.8-1.25.|Ratio of Geometric least squares mean|0.9538|||||TWO_SIDED|90.0|0.898|1.0132||||||||1.0132|0.8980|
72459528|NCT00134056|144441779|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.04||||0.64|TWO_SIDED|95.0|0.9|1.19|||Log Rank|||The primary analysis was by intention to treat and the Hochberg procedure was used for multiple testing of co-primary endpoints. Assuming a 4 year accrual, 2.5 years of follow-up, and 930 eligible patients, the study was designed to have 87% power to detect a 25% increase from 18.0 months to 22.5 months in median overall survival with a one-sided log rank with alpha of 0.0125.||1.19|0.90|0.64
72620955|NCT00452400|144772843|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.099|STANDARD_ERROR_OF_MEAN|0.043||0.023||95.0|0.014|0.184|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 10 mcg qd minus Placebo|||0.184|0.014|0.0230
72620956|NCT00452400|144772843|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.092|STANDARD_ERROR_OF_MEAN|0.043||0.0333||95.0|0.007|0.177|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 20 mcg qd minus Placebo|||0.177|0.007|0.0333
72459529|NCT00134056|144441780|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.02||||0.81|TWO_SIDED|95.0|0.89|1.16|||Log Rank|||The primary analysis was by intention to treat and the Hochberg procedure was used for multiple testing of co-primary endpoints. Assuming a 4 year accrual, 2.5 years of follow-up, and 930 eligible patients, the study was designed to have 87% power to detect a 25% increase from 6.0 months to 7.5 months in median overall survival with a one-sided log rank with alpha of 0.0125.||1.16|0.89|0.81
72459530|NCT00872339|144441798|SUPERIORITY_OR_OTHER|||||||0.45|||||||Chi-squared|||||||0.45
72620957|NCT00452400|144772844|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.053|STANDARD_ERROR_OF_MEAN|0.043||0.2158||95.0|-0.031|0.137|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 2 mcg qd minus Placebo|||0.137|-0.031|0.2158
72620958|NCT00452400|144772844|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.129|STANDARD_ERROR_OF_MEAN|0.042||0.0024||95.0|0.046|0.212|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 5 mcg qd minus Placebo|||0.212|0.046|0.0024
72620959|NCT00452400|144772844|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.14|STANDARD_ERROR_OF_MEAN|0.043||0.0013||95.0|0.055|0.225|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 10 mcg qd minus Placebo|||0.225|0.055|0.0013
72459531|NCT00872339|144441800|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Chi-squared|||||||<.001
72459532|NCT02312258|144441811|SUPERIORITY||Hazard Ratio (HR)|1.09|||=|0.473|TWO_SIDED|95.0|0.861|1.381|||Log Rank||||"P-value comparing OS between treatment groups was based on log-rank test stratified by initial therapy (proteasome inhibitor-containing or not), International Staging System (ISS) stage before initial therapy (stage I or II vs stage III), age (\<75 versus \[vs\] \>=75 years) at randomization, and best response to initial therapy (complete response (CR) or very good partial response (VGPR) vs partial response (PR)).~Hazard ratio was based on an unadjusted Cox's proportional hazard regression model stratified by initial therapy (proteasome inhibitor-containing or not), ISS stage before initial therapy (stage I or II vs stage III), age (\<75 versus\[vs\] \>=75 years) at randomization, and best response to initial therapy (CR or VGPR vs PR), comparing the hazard rate of ixazomib arm over the hazard rate of placebo arm. A less than 1 hazard ratio was to be considered statistically significant."|1.381|0.861|=0.473
72470155|NCT01012245|144464463|SUPERIORITY_OR_OTHER_LEGACY||Mean value|0.31|STANDARD_DEVIATION|0.15||||95.0|0.25|0.38||||||Horizontal C/D ratio 3 years (n=25)||0.38|0.25|
72470156|NCT01012245|144464463|SUPERIORITY_OR_OTHER_LEGACY||Mean value|0.49|STANDARD_DEVIATION|0.21||||95.0|0.42|0.57||||||Horizontal C/D ratio 3 years (n=35)||0.57|0.42|
72470157|NCT01012245|144464463|SUPERIORITY_OR_OTHER_LEGACY||Mean value|0.48|STANDARD_DEVIATION|0.26||||95.0|0.47|0.5||||||Horizontal C/D ratio 3 years (n=1204)||0.50|0.47|
72470158|NCT01475305|144464502|SUPERIORITY_OR_OTHER||Relative Risk|0.0|||||TWO_SIDED|95.0|0.0|2.05|||||Relative risk was calculated as the proportion of participants with RSV infection in the MEDI-557 arm divided by the proportion of participants with RSV infection in the placebo arm.|||2.05|0.00|
72470159|NCT01475305|144464503|SUPERIORITY_OR_OTHER||Relative Risk|1.0|||||TWO_SIDED|95.0|0.16|6.24|||||Relative risk was calculated as the proportion of participants with RSV infection in the MEDI-557 arm divided by the proportion of participants with RSV infection in the placebo arm.|RSV infection by quantitative real-time RT-PCR||6.24|0.16|
72470160|NCT01475305|144464503|SUPERIORITY_OR_OTHER||Relative Risk|0.0|||||TWO_SIDED|95.0|0.0|2.05|||||Relative risk was calculated as the proportion of participants with RSV infection in the MEDI-557 arm divided by the proportion of participants with RSV infection in the placebo arm.|RSV infection by DFA||2.05|0.00|
72470161|NCT01475305|144464503|SUPERIORITY_OR_OTHER||Relative Risk|1.0|||||TWO_SIDED|95.0|0.16|6.24|||||Relative risk was calculated as the proportion of participants with RSV infection in the MEDI-557 arm divided by the proportion of participants with RSV infection in the placebo arm.|RSV infection by Any Method||6.24|0.16|
72470162|NCT00132678|144464526|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.4|||<|0.001||95.0|0.27|0.59|||Log Rank|Adjusting for country|RISPERDAL CONSTA hazard in numerator, placebo hazard in denominator.|||0.59|0.27|<0.001
72470163|NCT00132678|144464527|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.9|STANDARD_ERROR_OF_MEAN|1.09|<|0.001||95.0|-8.08|-3.79|||ANCOVA|ANCOVA model with factors for treatment and country and double-blind baseline value as covariate.|Change in RISPERDAL CONSTA arm minus change in placebo arm.|||-3.79|-8.08|<0.001
72470164|NCT00132678|144464528|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.0|STANDARD_ERROR_OF_MEAN|0.87||0.02||95.0|-3.75|-0.32|||ANCOVA|ANCOVA model with factors for treatment and country and double-blind baseline value as covariate.|Change in RISPERDAL CONSTA arm minus change in placebo arm.|||-0.32|-3.75|0.020
72470165|NCT00592293|144464534|OTHER||Cumulative incidence|17.0|||||TWO_SIDED|95.0|9.1|27.6||||||||27.6|9.1|
72459533|NCT02312258|144441813|SUPERIORITY||Hazard Ratio (HR)|0.655|||<|0.001|TWO_SIDED|95.0|0.537|0.799|||Log Rank||||"P-value comparing TTP between treatment groups was based on log-rank test stratified by initial therapy (proteasome inhibitor-containing or not), ISS stage before initial therapy (stage I or II vs stage III), age (\<75 vs \>=75 years) at randomization, and best response to initial therapy (CR or VGPR vs PR).~Hazard ratio was based on an unadjusted Cox's proportional hazard regression model stratified by initial therapy (proteasome inhibitor-containing or not), ISS stage before initial therapy (stage I or II vs stage III), age (\<75 vs \>=75 years) at randomization, and best response to initial therapy (CR or VGPR vs PR), comparing the hazard rate of ixazomib arm over the hazard rate of placebo arm. A less than 1 hazard ratio was to be considered statistically significant."|0.799|0.537|<0.001
72563235|NCT00442546|144658162|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.061|STANDARD_ERROR_OF_MEAN|0.353||0.8637||95.0|-0.636|0.757|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4||0.757|-0.636|0.8637
72370521|NCT00488683|144251632|SUPERIORITY_OR_OTHER||R-square|0.0077||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one month after booster vaccination for the serogroup C||||
72459534|NCT02312258|144441814|SUPERIORITY||Hazard Ratio (HR)|0.984|||=|0.893|TWO_SIDED|95.0|0.777|1.246|||Log Rank||||"P-value comparing PFS2 between treatment groups was based on log-rank test stratified by initial therapy (proteasome inhibitor-containing or not), ISS stage before initial therapy (stage I or II vs stage III), age (\<75 vs \>=75 years) at randomization, and best response to initial therapy (CR or VGPR vs PR).~Hazard ratio was based on an unadjusted Cox's proportional hazard regression model stratified by initial therapy (proteasome inhibitor-containing or not), ISS stage before initial therapy (stage I or II vs stage III), age (\<75 vs \>=75 years) at randomization, and best response to initial therapy (CR or VGPR vs PR), comparing the hazard rate of ixazomib arm over the hazard rate of placebo arm. A less than 1 hazard ratio was to be considered statistically significant."|1.246|0.777|=0.893
72459535|NCT02312258|144441815|SUPERIORITY||Hazard Ratio (HR)|0.777|||=|0.018|TWO_SIDED|95.0|0.631|0.957|||Log Rank||||"P-value comparing TTNT between treatment groups was based on log-rank test stratified by initial therapy (proteasome inhibitor-containing or not), ISS stage before initial therapy (stage I or II vs stage III), age (\<75 vs \>=75 years) at randomization, and best response to initial therapy (CR or VGPR vs PR).~Hazard ratio was based on an unadjusted Cox's proportional hazard regression model stratified by initial therapy (proteasome inhibitor-containing or not), ISS stage before initial therapy (stage I or II vs stage III), age (\<75 vs \>=75 years) at randomization, and best response to initial therapy (CR or VGPR vs PR), comparing the hazard rate of ixazomib arm over the hazard rate of placebo arm. A less than 1 hazard ratio was to be considered statistically significant."|0.957|0.631|=0.018
72459536|NCT02312258|144441816|SUPERIORITY||Hazard Ratio (HR)|1.111|||=|0.462|TWO_SIDED|95.0|0.839|1.47|||Log Rank||||"P-value comparing Time to End of Next Line Therapy between treatment groups was based on log-rank test stratified by initial therapy (proteasome inhibitor-containing or not), ISS stage before initial therapy (stage I or II vs stage III), age (\<75 vs \>=75 years) at randomization, and best response to initial therapy (CR or VGPR vs PR).~Hazard ratio was based on an unadjusted Cox's proportional hazard regression model stratified by initial therapy (proteasome inhibitor-containing or not), ISS stage before initial therapy (stage I or II vs stage III), age (\<75 vs \>=75 years) at randomization, and best response to initial therapy (CR or VGPR vs PR), comparing the hazard rate of ixazomib arm over the hazard rate of placebo arm. A less than 1 hazard ratio was to be considered statistically significant."|1.470|0.839|=0.462
72459537|NCT02312258|144441817|SUPERIORITY||Hazard Ratio (HR)|1.293|||||TWO_SIDED|95.0|0.968|1.727|||||||Hazard ratio was based on an unadjusted Cox's proportional hazard regression model stratified by initial therapy (proteasome inhibitor-containing or not), ISS stage before initial therapy (stage I or II vs stage III), age (\<75 vs \>=75 years) at randomization, and best response to initial therapy (CR or VGPR vs PR), comparing the hazard rate of ixazomib arm over the hazard rate of placebo arm. A less than 1 hazard ratio was to be considered statistically significant.|1.727|0.968|
72459538|NCT02312258|144441820|SUPERIORITY||Hazard Ratio (HR)|0.582|||=|0.001|TWO_SIDED|95.0|0.425|0.796|||Log Rank|||PFS for Participants with Known MRD+ at Study Entry|"P-value comparing PFS between treatment groups was based on log-rank test stratified by initial therapy (proteasome inhibitor-containing or not), ISS stage before initial therapy (stage I or II vs stage III), age (\<75 vs \>=75 years) at randomization, and best response to initial therapy (CR or VGPR vs PR).~Hazard ratio was based on an unadjusted Cox's proportional hazard regression model stratified by initial therapy (proteasome inhibitor-containing or not), ISS stage before initial therapy (stage I or II vs stage III), age (\<75 vs \>=75 years) at randomization, and best response to initial therapy (CR or VGPR vs PR), comparing the hazard rate of ixazomib arm over the hazard rate of placebo arm. A less than 1 hazard ratio was to be considered statistically significant."|0.796|0.425|=0.001
72459539|NCT02312258|144441820|SUPERIORITY||Hazard Ratio (HR)|1.537|||=|0.398|TWO_SIDED|95.0|0.563|4.194|||Log Rank|||PFS for Participants with Known MRD- at Study Entry|"P-value comparing PFS between treatment groups was based on log-rank test stratified by initial therapy (proteasome inhibitor-containing or not), ISS stage before initial therapy (stage I or II vs stage III), age (\<75 vs \>=75 years) at randomization, and best response to initial therapy (CR or VGPR vs PR).~Hazard ratio was based on an unadjusted Cox's proportional hazard regression model stratified by initial therapy (proteasome inhibitor-containing or not), ISS stage before initial therapy (stage I or II vs stage III), age (\<75 vs \>=75 years) at randomization, and best response to initial therapy (CR or VGPR vs PR), comparing the hazard rate of ixazomib arm over the hazard rate of placebo arm. A less than 1 hazard ratio was to be considered statistically significant."|4.194|0.563|=0.398
72470166|NCT00592293|144464535|OTHER||Percent Survival, Local Control|87.1|||||TWO_SIDED|95.0|78.1|93.7||||||||93.7|78.1|
72470167|NCT01124097|144464559|SUPERIORITY_OR_OTHER|||||||0.9321|||||||Dunnett's test|||||||0.9321
72470168|NCT01124097|144464559|SUPERIORITY_OR_OTHER|||||||0.261|||||||Dunnett's test|||||||0.2610
72470169|NCT01124097|144464559|SUPERIORITY_OR_OTHER|||||||0.4764|||||||Dunnett's test|||||||0.4764
72563236|NCT00442546|144658162|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.019|STANDARD_ERROR_OF_MEAN|0.359||0.9585||95.0|-0.727|0.689|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4||0.689|-0.727|0.9585
72563237|NCT00442546|144658162|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.272|STANDARD_ERROR_OF_MEAN|0.321||0.3975||95.0|-0.906|0.361|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET||0.361|-0.906|0.3975
72459540|NCT02312258|144441820|SUPERIORITY||Hazard Ratio (HR)|10.173|||=|0.012|TWO_SIDED|95.0|1.194|86.649|||Log Rank|||OS for Participants with Known MRD Status (MRD- Status, MRD+ Status) at Study Entry|"P-value comparing OS between treatment groups was based on log-rank test stratified by initial therapy (proteasome inhibitor-containing or not), ISS stage before initial therapy (stage I or II vs stage III), age (\<75 vs \>=75 years) at randomization, and best response to initial therapy (CR or VGPR vs PR).~Hazard ratio was based on an unadjusted Cox's proportional hazard regression model stratified by initial therapy (proteasome inhibitor-containing or not), ISS stage before initial therapy (stage I or II vs stage III), age (\<75 vs \>=75 years) at randomization, and best response to initial therapy (CR or VGPR vs PR), comparing the hazard rate of ixazomib arm over the hazard rate of placebo arm. A less than 1 hazard ratio was to be considered statistically significant."|86.649|1.194|=0.012
72459541|NCT02312258|144441822|SUPERIORITY||Hazard Ratio (HR)|1.011|||=|0.963|TWO_SIDED|95.0|0.631|1.621|||Log Rank||||"P-value comparing PFS between treatment groups was based on log-rank test stratified by initial therapy (proteasome inhibitor-containing or not), ISS stage before initial therapy (stage I or II vs stage III), age (\<75 vs \>=75 years) at randomization, and best response to initial therapy (CR or VGPR vs PR).~Hazard ratio was based on an unadjusted Cox's proportional hazard regression model stratified by initial therapy (proteasome inhibitor-containing or not), ISS stage before initial therapy (stage I or II vs stage III), age (\<75 vs \>=75 years) at randomization, and best response to initial therapy (CR or VGPR vs PR), comparing the hazard rate of ixazomib arm over the hazard rate of placebo arm. A less than 1 hazard ratio was to be considered statistically significant."|1.621|0.631|=0.963
72459542|NCT02312258|144441826|SUPERIORITY||Hazard Ratio (HR)|0.53|||<|0.001|TWO_SIDED|95.0|0.387|0.727|||Log Rank|||PFS Based on Frailty Status of Fit|"P-value comparing PFS between treatment groups was based on Log-rank test stratified by initial therapy (proteasome inhibitor-containing or not), ISS stage before initial therapy (stage I or II vs stage III), and age (\<75 vs \>=75 years) at randomization.~Hazard ratio was based on an unadjusted Cox's proportional hazard regression model stratified by initial therapy (proteasome inhibitor-containing or not), ISS stage before initial therapy (stage I or II vs stage III), and age (\<75 vs \>=75 years) at randomization, comparing the hazard rate of ixazomib arm over the hazard rate of placebo arm. A less than 1 hazard ratio was to be considered statistically significant."|0.727|0.387|<0.001
72459543|NCT02312258|144441826|SUPERIORITY||Hazard Ratio (HR)|0.746|||=|0.098|TWO_SIDED|95.0|0.526|1.058|||Log Rank|||PFS Based on Frailty Status of Unfit|"P-value comparing PFS between treatment groups was based on Log-rank test stratified by initial therapy (proteasome inhibitor-containing or not), ISS stage before initial therapy (stage I or II vs stage III), and age (\<75 vs \>=75 years) at randomization.~Hazard ratio was based on an unadjusted Cox's proportional hazard regression model stratified by initial therapy (proteasome inhibitor-containing or not), ISS stage before initial therapy (stage I or II vs stage III), and age (\<75 vs \>=75 years) at randomization, comparing the hazard rate of ixazomib arm over the hazard rate of placebo arm. A less than 1 hazard ratio was to be considered statistically significant."|1.058|0.526|=0.098
72459544|NCT02312258|144441826|SUPERIORITY||Hazard Ratio (HR)|0.733|||=|0.147|TWO_SIDED|95.0|0.481|1.117|||Log Rank|||PFS Based on Frailty Status of Frail|"P-value comparing PFS between treatment groups was based on Log-rank test stratified by initial therapy (proteasome inhibitor-containing or not), ISS stage before initial therapy (stage I or II vs stage III), and age (\<75 vs \>=75 years) at randomization.~Hazard ratio was based on an unadjusted Cox's proportional hazard regression model stratified by initial therapy (proteasome inhibitor-containing or not), ISS stage before initial therapy (stage I or II vs stage III), and age (\<75 vs \>=75 years) at randomization, comparing the hazard rate of ixazomib arm over the hazard rate of placebo arm. A less than 1 hazard ratio was to be considered statistically significant."|1.117|0.481|=0.147
72459545|NCT02312258|144441826|SUPERIORITY||Hazard Ratio (HR)|0.897|||=|0.714|TWO_SIDED|95.0|0.502|1.602|||Log Rank|||OS Based on Frailty Status of Fit|"P-value comparing OS between treatment groups was based on log-rank test stratified by initial therapy (proteasome inhibitor-containing or not), ISS stage before initial therapy (stage I or II vs stage III), age (\<75 vs \>=75 years) at randomization, and best response to initial therapy (CR or VGPR vs PR).~Hazard ratio was based on an unadjusted Cox's proportional hazard regression model stratified by initial therapy (proteasome inhibitor-containing or not), ISS stage before initial therapy (stage I or II vs stage III), age (\<75 vs \>=75 years) at randomization, and best response to initial therapy (CR or VGPR vs PR), comparing the hazard rate of ixazomib arm over the hazard rate of placebo arm. A less than 1 hazard ratio was to be considered statistically significant."|1.602|0.502|=0.714
72501031|NCT01381094|144532151|SUPERIORITY||||||<|0.0001|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 6).||||<0.0001
72501032|NCT01381094|144532151|SUPERIORITY||||||<|0.0001|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 6).||||<0.0001
72501033|NCT01381094|144532151|SUPERIORITY||||||=|0.6781|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 6).||||=0.6781
72501034|NCT01381094|144532151|SUPERIORITY||||||=|0.0524|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).||||=0.0524
72501035|NCT01381094|144532151|SUPERIORITY||||||=|0.0367|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).||||=0.0367
72501036|NCT01381094|144532151|SUPERIORITY||||||=|0.6671|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).||||=0.6671
72459546|NCT02312258|144441826|SUPERIORITY||Hazard Ratio (HR)|1.75|||=|0.124|TWO_SIDED|95.0|0.85|3.601|||Log Rank|||OS Based on Frailty Status of Unfit|"P-value comparing OS between treatment groups was based on log-rank test stratified by initial therapy (proteasome inhibitor-containing or not), ISS stage before initial therapy (stage I or II vs stage III), age (\<75 vs \>=75 years) at randomization, and best response to initial therapy (CR or VGPR vs PR).~Hazard ratio was based on an unadjusted Cox's proportional hazard regression model stratified by initial therapy (proteasome inhibitor-containing or not), ISS stage before initial therapy (stage I or II vs stage III), age (\<75 vs \>=75 years) at randomization, and best response to initial therapy (CR or VGPR vs PR), comparing the hazard rate of ixazomib arm over the hazard rate of placebo arm. A less than 1 hazard ratio was to be considered statistically significant."|3.601|0.850|=0.124
72459547|NCT02312258|144441826|SUPERIORITY||Hazard Ratio (HR)|0.854|||=|0.63|TWO_SIDED|95.0|0.448|1.627|||Log Rank|||OS Based on Frailty Status of Frail|"P-value comparing OS between treatment groups was based on log-rank test stratified by initial therapy (proteasome inhibitor-containing or not), ISS stage before initial therapy (stage I or II vs stage III), age (\<75 vs \>=75 years) at randomization, and best response to initial therapy (CR or VGPR vs PR).~Hazard ratio was based on an unadjusted Cox's proportional hazard regression model stratified by initial therapy (proteasome inhibitor-containing or not), ISS stage before initial therapy (stage I or II vs stage III), age (\<75 vs \>=75 years) at randomization, and best response to initial therapy (CR or VGPR vs PR), comparing the hazard rate of ixazomib arm over the hazard rate of placebo arm. A less than 1 hazard ratio was to be considered statistically significant."|1.627|0.448|=0.630
72459548|NCT00267774|144441936|OTHER||||||<|0.0001||||||A 2-sided value of P\<0.05 was considered to indicate statistical significance.|t-test, 2 sided|||||||<0.0001
72459549|NCT03444298|144441937|SUPERIORITY|||||||0.67||||||The a priori threshold for statistical significance is \<0.05.|t-test, 2 sided|||||||0.67
72459550|NCT03444298|144441938|SUPERIORITY|||||||0.43||||||The a priori threshold for statistical significance is \<0.05.|Mixed Models Analysis|||||||0.43
72459551|NCT03444298|144441939|SUPERIORITY|||||||0.27||||||The a priori threshold for statistical significance is \<0.05.|t-test, 2 sided|||||||0.27
72459552|NCT03444298|144441940|SUPERIORITY|||||||0.92||||||The a priori threshold for statistical significance is \<0.05.|t-test, 2 sided|||||||0.92
72459553|NCT03444298|144441941|SUPERIORITY|||||||0.99||||||The a priori threshold for statistical significance is \<0.05.|Mixed Models Analysis|||||||0.99
72459554|NCT03444298|144441941|SUPERIORITY|||||||0.04||||||The a priori threshold for statistical significance is \<0.05.|Mixed Models Analysis|||||||0.04
72501037|NCT01381094|144532151|SUPERIORITY||||||=|0.6861|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).||||=0.6861
72501038|NCT01381094|144532151|SUPERIORITY||||||=|0.9012|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).||||=0.9012
72501039|NCT01381094|144532152|SUPERIORITY||||||=|0.3953|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 2).||||=0.3953
72501040|NCT01381094|144532152|SUPERIORITY||||||=|0.085|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 2).||||=0.0850
72501041|NCT01381094|144532152|SUPERIORITY||||||=|0.6045|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 2).||||=0.6045
72501042|NCT01381094|144532152|SUPERIORITY||||||=|0.7743|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 2).||||=0.7743
72459555|NCT03444298|144441942|SUPERIORITY|||||||0.98||||||The a priori threshold for statistical significance is \<0.05.|Mixed Models Analysis|||||||0.98
72459556|NCT03444298|144441942|SUPERIORITY|||||||0.02||||||The a priori threshold for statistical significance is \<0.05.|Mixed Models Analysis|||||||0.02
72459557|NCT03444298|144441943|SUPERIORITY|||||||0.84||||||The a priori threshold for statistical significance is \<0.05.|Mixed Models Analysis|||||||0.84
72459558|NCT03444298|144441944|SUPERIORITY|||||||0.59||||||The a priori threshold for statistical significance is \<0.05.|Mixed Models Analysis|||||||0.59
72459559|NCT03444298|144441945|SUPERIORITY|||||||0.83||||||The a priori threshold for statistical significance is \<0.05.|Mixed Models Analysis|||||||0.83
72459560|NCT03444298|144441946|SUPERIORITY|||||||0.51||||||The a priori threshold for statistical significance is \<0.05.|Mixed Models Analysis|||||||0.51
72459561|NCT03444298|144441947|SUPERIORITY|||||||0.48||||||The a priori threshold for statistical significance is \<0.05.|t-test, 2 sided|||||||0.48
72459562|NCT03444298|144441948|SUPERIORITY||||||<|0.01||||||The a priori threshold for statistical significance is \<0.05.|t-test, 2 sided|||||||<0.01
72459563|NCT03444298|144441949|SUPERIORITY||||||<|0.0001||||||The a priori threshold for statistical significance is \<0.05.|t-test, 2 sided|||||||<0.0001
72459564|NCT00946998|144441975|SUPERIORITY|||||||0.82|||||||Mixed Models Analysis|||||||0.82
72459565|NCT00946998|144441976|SUPERIORITY|||||||0.28||||||Represents the response outcome.|Mixed Models Analysis|||||||0.28
72459566|NCT00946998|144441976|SUPERIORITY|||||||0.86||||||Represents remission outcome.|Mixed Models Analysis|||||||0.86
72459567|NCT00946998|144441977|SUPERIORITY|||||||0.32|||||||Mixed Models Analysis|||||||0.32
72459568|NCT00946998|144441978|SUPERIORITY|||||||0.61|||||||Mixed Models Analysis|||||||0.61
72459569|NCT00946998|144441979|SUPERIORITY||||||>|0.99||||||For death|Chi-squared|||||||>.99
72459570|NCT00946998|144441979|SUPERIORITY|||||||0.77||||||For comparison of dialysis initiation between groups.|Chi-squared|||||||0.77
72392509|NCT01652703|144292429|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-53.44|STANDARD_ERROR_OF_MEAN|2.77|<|0.001|TWO_SIDED|95.0|-58.91|-47.97||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factor of screening LDL-C level.|Placebo is the reference|||-47.97|-58.91|<0.001
72459571|NCT00946998|144441979|SUPERIORITY||||||>|0.99||||||Hospitalization other than dialysis initiation|Chi-squared|||||||>0.99
72459572|NCT00946998|144441979|SUPERIORITY|||||||0.5||||||For comparison of acute suicidal intent.|Chi-squared|||||||0.5
72459573|NCT00946998|144441979|SUPERIORITY||||||>|0.99||||||For comparison of bleeding requiring blood transfusion or hospitalization.|Chi-squared|||||||>0.99
72459574|NCT01857362|144441980|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established if the 90% confidence interval for the ratio is completely within the acceptance range (0.80-1.25)|Ratio of geomectric means|1.0|||||TWO_SIDED|90.0|0.988|1.045|||ANOVA|||||1.045|0.988|
72459575|NCT01857362|144441981|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established if the 90% confidence interval for the ratio is completely within the acceptance range (0.80-1.25)|ratio of geometric means|0.989|||||TWO_SIDED|90.0|0.945|1.034|||ANOVA|||||1.034|0.945|
72459576|NCT00507429|144441995|SUPERIORITY_OR_OTHER|||||||0.223|||||||Log Rank|||||||0.223
72459577|NCT03785756|144442015|EQUIVALENCE|The primary analysis was based on a two-sided test at the significance level of 0.05. The treatment difference is presented with a 95% confidence interval (CI).|Mean Difference (Final Values)|34.05|||<|0.0001|TWO_SIDED|95.0|26.72|41.38|||ANCOVA|Estimates from an ANCOVA model with SPID12 score as the dependent variable. Terms for treatment and baseline pain score were included as covariates.||The primary efficacy hypothesis was that SPID12 for placebo was equal to SPID12 for ibuprofen 2 × 300 mg PR tablets.||41.38|26.72|<0.0001
72459578|NCT01345253|144442141|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.99||||0.0001|TWO_SIDED|95.0|1.4|2.82|||Regression, Logistic||Odds Ratio (95% CI) and p-value were estimated by a logistic regression model with independent variables treatment group, country, Baseline SELENA SLEDAI score (\<=9 vs. \>=10) and complement (C) levels (low C3 and/or C4 vs. no low C3 or C4).|||2.82|1.40|0.0001
72459579|NCT01345253|144442142|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.0||||0.0001|TWO_SIDED|95.0|1.41|2.83|||Regression, Logistic||Odds Ratio (95% CI) and p-value were estimated by a logistic regression model with independent variables treatment group, country, Baseline SELENA SLEDAI score (\<=9 vs. \>=10) and complement levels (low C3 and/or C4 vs. no low C3 or C4).|||2.83|1.41|0.0001
72501043|NCT01381094|144532152|SUPERIORITY||||||=|0.5326|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 2).||||=0.5326
72501044|NCT01381094|144532152|SUPERIORITY||||||=|0.3465|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 4).||||=0.3465
72501045|NCT01381094|144532152|SUPERIORITY||||||=|0.2756|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 4).||||=0.2756
72501046|NCT01381094|144532152|SUPERIORITY||||||=|0.1414|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 4).||||=0.1414
72501047|NCT01381094|144532152|SUPERIORITY||||||=|0.6941|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 4).||||=0.6941
72459580|NCT01345253|144442143|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.76||||0.0116|TWO_SIDED|95.0|1.13|2.74|||Regression, Logistic||Odds Ratio (95% CI) and p-value were estimated by a logistic regression model with independent variables treatment group, country, baseline SELENA SLEDAI score (\<=9 vs. \>=10) and complement levels (low C3 and/or C4 vs. no low C3 or C4).|||2.74|1.13|0.0116
72459581|NCT01345253|144442144|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0288|||||||Rank ANCOVA|||||||0.0288
72459582|NCT01345253|144442145|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.5||||0.0004|TWO_SIDED|95.0|0.34|0.73|||Regression, Cox|||||0.73|0.34|0.0004
72459583|NCT01767376|144442160|NON_INFERIORITY|Non-inferiority was defined as the lower limit (LL) of the two-sided standardised asymptotic 95% confidence interval (CI) for rSBA GMT ratios for serogroup A between the two groups (Nimenrix+Boostrix Group minus Nimenrix Group) being greater than or equal to (≥) the pre-defined limit of 0.5.|Adjusted GMT ratio|1.19|||||TWO_SIDED|95.0|0.97|1.48|||ANCOVA|||To demonstrate the non-inferiority of Nimenrix co-administered with Boostrix (Nimenrix+Boostrix Group) compared to Nimenrix administered alone (Nimenrix Group) with respect to serum bactericidal assay using rabbit complement (rSBA) geometric mean titers (GMTs) for serogroup A, one month after Nimenrix vaccination.||1.48|0.97|
72459584|NCT01767376|144442160|NON_INFERIORITY|Non-inferiority was defined as the lower limit (LL) of the two-sided standardised asymptotic 95% confidence interval (CI) for rSBA GMT ratios for serogroup C between the two groups (Nimenrix+Boostrix Group minus Nimenrix Group) being greater than or equal to (≥) the pre-defined limit of 0.5.|Adjusted GMT ratio|1.12|||||TWO_SIDED|95.0|0.85|1.47|||ANCOVA|||To demonstrate the non-inferiority of Nimenrix co-administered with Boostrix (Nimenrix+Boostrix Group) compared to Nimenrix administered alone (Nimenrix Group) with respect to serum bactericidal assay using rabbit complement (rSBA) geometric mean titers (GMTs) for serogroup C, one month after Nimenrix vaccination.||1.47|0.85|
72459585|NCT01767376|144442160|NON_INFERIORITY|Non-inferiority was defined as the lower limit (LL) of the two-sided standardised asymptotic 95% confidence interval (CI) for rSBA GMT ratios for serogroup W-135 between the two groups (Nimenrix+Boostrix Group minus Nimenrix Group) being greater than or equal to (≥) the pre-defined limit of 0.5.|Adjusted GMT ratio|1.06|||||TWO_SIDED|95.0|0.86|1.32|||ANCOVA|||To demonstrate the non-inferiority of Nimenrix co-administered with Boostrix (Nimenrix+Boostrix Group) compared to Nimenrix administered alone (Nimenrix Group) with respect to serum bactericidal assay using rabbit complement (rSBA) geometric mean titers (GMTs) for serogroup W-135, one month after Nimenrix vaccination.||1.32|0.86|
72459586|NCT01767376|144442160|NON_INFERIORITY|Non-inferiority was defined as the lower limit (LL) of the two-sided standardised asymptotic 95% confidence interval (CI) for rSBA GMT ratios for serogroup Y between the two groups (Nimenrix+Boostrix Group minus Nimenrix Group) being greater than or equal to (≥) the pre-defined limit of 0.5.|Adjusted GMT ratio|1.27|||||TWO_SIDED|95.0|1.02|1.59|||ANCOVA|||To demonstrate the non-inferiority of Nimenrix co-administered with Boostrix (Nimenrix+Boostrix Group) compared to Nimenrix administered alone (Nimenrix Group) with respect to serum bactericidal assay using rabbit complement (rSBA) geometric mean titers (GMTs) for serogroup Y, one month after Nimenrix vaccination.||1.59|1.02|
72459587|NCT01767376|144442161|NON_INFERIORITY|Non-inferiority was defined as the lower limit (LL) of the two-sided standardized asymptotic 95% confidence interval (CI) between the two groups (Nimenrix+Boostrix Group minus Boostrix Group), in terms of percentage of subjects with anti-D concentrations ≥ 1.0 IU/mL, being greater than or equal to (≥) the pre-defined limit of -10%.|Difference in percentage|-2.14|||||TWO_SIDED|95.0|-7.88|3.53||||||To demonstrate the non-inferiority of Boostrix co-administered with Nimenrix (Nimenrix+Boostrix Group) compared to Boostrix administered alone (Boostrix Group) in terms of anti-diphtheria toxoid (anti-D) antibody concentrations one month after Boostrix vaccination.||3.53|-7.88|
72459588|NCT01767376|144442161|NON_INFERIORITY|Non-inferiority was defined as the lower limit (LL) of the two-sided standardized asymptotic 95% confidence interval (CI) between the two groups (Nimenrix+Boostrix Group minus Boostrix Group), in terms of percentage of subjects with anti-T concentrations ≥ 1.0 IU/mL, being greater than or equal to (≥) the pre-defined limit of -10%.|Difference in percentage|-0.44|||||TWO_SIDED|95.0|-2.48|1.26||||||To demonstrate the non-inferiority of Boostrix co-administered with Nimenrix (Nimenrix+Boostrix Group) compared to Boostrix administered alone (Boostrix Group) in terms of anti-tetanus toxoid (anti-T) antibody concentrations one month after Boostrix vaccination.||1.26|-2.48|
72459589|NCT01767376|144442162|NON_INFERIORITY|Non-inferiority was defined as the lower limit (LL) of the two-sided standardized asymptotic 95% confidence interval (CI) between the two groups (Nimenrix+Boostrix Group minus Boostrix Group) for GMC ratios of antibodies against the pertussis (PT) antigen, being greater than or equal to (≥) the predefined limit of 0.67.|Adjusted GMC ratio|0.76|||||TWO_SIDED|95.0|0.66|0.89|||ANCOVA|||To demonstrate the non-inferiority of Boostrix co-administered with Nimenrix (Nimenrix+Boostrix Group) compared to Boostrix administered alone (Boostrix Group) with respect to geometric mean concentrations (GMCs) of antibodies against pertussis toxoid (PT), one month after Boostrix vaccination.||0.89|0.66|
72459590|NCT01767376|144442162|NON_INFERIORITY|Non-inferiority was defined as the lower limit (LL) of the two-sided standardized asymptotic 95% confidence interval (CI) between the two groups (Nimenrix+Boostrix Group minus Boostrix Group) for GMC ratios of antibodies against the filamentous haemagglutinin (FHA) antigen, being greater than or equal to (≥) the predefined limit of 0.67.|Adjusted GMC ratio|0.57|||||TWO_SIDED|95.0|0.5|0.65|||ANCOVA|||To demonstrate the non-inferiority of Boostrix co-administered with Nimenrix (Nimenrix+Boostrix Group) compared to Boostrix administered alone (Boostrix Group) with respect to geometric mean concentrations (GMCs) of antibodies against filamentous haemagglutinin (FHA), one month after Boostrix vaccination.||0.65|0.50|
72459591|NCT01767376|144442162|NON_INFERIORITY|Non-inferiority was defined as the lower limit (LL) of the two-sided standardized asymptotic 95% confidence interval (CI) between the two groups (Nimenrix+Boostrix Group minus Boostrix Group) for GMC ratios of antibodies against the pertactin (PRN) antigen, being greater than or equal to (≥) the predefined limit of 0.67.|Adjusted GMC ratio|0.72|||||TWO_SIDED|95.0|0.59|0.88|||ANCOVA|||To demonstrate the non-inferiority of Boostrix co-administered with Nimenrix (Nimenrix+Boostrix Group) compared to Boostrix administered alone (Boostrix Group) with respect to geometric mean concentrations (GMCs) of antibodies against pertactin (PRN), one month after Boostrix vaccination.||0.88|0.59|
72459592|NCT04387773|144442174|SUPERIORITY||Mean Difference (Final Values)|2.3|||>|0.05|TWO_SIDED||||||t-test, 2 sided|||We hypothesized that GOCOVRI would result in an increase of daily activity due to improvement in LID symptoms.||||>.05
72459593|NCT04387773|144442175|SUPERIORITY||Mean Difference (Final Values)|14.98|||>|0.05|TWO_SIDED||||||t-test, 2 sided|||We hypothesized that GOCOVRI would result in an increase of daily activity due to improvement in LID symptoms.||||>.05
72459594|NCT04387773|144442176|SUPERIORITY||Mean Difference (Final Values)|2393.2||||0.037|TWO_SIDED||||||t-test, 2 sided|||||||0.037
72459595|NCT04387773|144442177|SUPERIORITY||Mean Difference (Final Values)|0.03||||0.012|TWO_SIDED||||||t-test, 2 sided|||||||0.012
72459596|NCT04387773|144442178|SUPERIORITY||Mean Difference (Final Values)|0.02||||0.047|TWO_SIDED||||||t-test, 2 sided|||||||0.047
72459597|NCT04883541|144442199|SUPERIORITY|the t-test in independent groups|Mean Difference (Net)|0.02|STANDARD_DEVIATION|0.8|<|0.05|TWO_SIDED|0.05|||||t-test, 2 sided|||||||<0.05
72501048|NCT01381094|144532152|SUPERIORITY||||||=|0.9403|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 4).||||=0.9403
72501049|NCT01381094|144532152|SUPERIORITY||||||=|0.831|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 6).||||=0.8310
72459598|NCT00841321|144442218|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.15||0.1|TWO_SIDED|95.0|-0.5|0.1||Nominal value. Per protocol univariate tests would only be considered significant in the multivariate test was significant.|ANCOVA|||PASAT Exit Z-score least square means difference adjusted for baseline. Positive values indicate a beneficial effect from treatment with Ginkgo.||0.1|-0.5|.1
72459599|NCT00841321|144442218|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|0.2||0.007|TWO_SIDED|95.0|-0.9|-0.1||Not adjusted for multiple comparison. Nominal value. Per protocol univariate tests would only be considered significant in the multivariate test was significant.|ANCOVA|||Stroop Exit Z-score least square means difference adjusted for baseline.Positive values indicate a beneficial effect from treatment with Ginkgo.||-0.1|-0.9|0.007
72459600|NCT00841321|144442218|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.1||0.5|TWO_SIDED|95.0|-0.2|0.3||Not adjusted for multiple comparison. Nominal value. Per protocol univariate tests would only be considered significant in the multivariate test was significant.|ANCOVA|||COWAT Exit Z-score least square means difference adjusted for baseline. Positive values indicate a beneficial effect from treatment with Ginkgo.||0.3|-0.2|0.5
72392510|NCT01652703|144292429|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-47.37|STANDARD_ERROR_OF_MEAN|2.8|<|0.001|TWO_SIDED|95.0|-52.9|-41.85||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factor of screening LDL-C level.|Placebo is the reference|||-41.85|-52.90|<0.001
72392511|NCT01652703|144292430|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-34.49|STANDARD_ERROR_OF_MEAN|11.75||0.004|TWO_SIDED|95.0|-57.71|-11.26||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factor of screening LDL-C level.|Placebo is the reference|||-11.26|-57.71|0.004
72392512|NCT01652703|144292430|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-24.25|STANDARD_ERROR_OF_MEAN|11.93||0.044|TWO_SIDED|95.0|-47.83|-0.68||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factor of screening LDL-C level.|Placebo is the reference|||-0.68|-47.83|0.044
72459601|NCT00841321|144442218|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.15||0.5||95.0|-0.3|0.3||Not adjusted for multiple comparison. Nominal value. Per protocol univariate tests would only be considered significant in the multivariate test was significant.|ANCOVA|||CVLT-II Delayed Recall Exit Z-score least square means difference adjusted for baseline. Positive values indicate a beneficial effect from treatment with Ginkgo.||0.3|-0.3|0.5
72459602|NCT00841321|144442218|SUPERIORITY_OR_OTHER|||||||0.19|||||||MANCOVA|MANCOVA||MANCOVA for all four cognitive tests at exit adjusting for baseline. Individual ANOVAs were to follow if the multivariate test was significant.||||0.19
72459603|NCT00841321|144442219|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|2.7||0.4|TWO_SIDED|95.0|-5.7|4.7|||ANCOVA||Positive values indicate a beneficial effect from Ginkgo.|Perceived Deficits Questionnaire||4.7|-5.7|0.4
72459604|NCT00841321|144442219|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.8|STANDARD_ERROR_OF_MEAN|2.0||0.7||95.0|-3.2|4.8|||ANCOVA||Positive values indicate a beneficial effect from Ginkgo.|Multiple Sclerosis Neuropsychological Questionnaire||4.8|-3.2|0.7
72459605|NCT00841321|144442219|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.6||0.4||95.0|-1.3|0.8|||ANCOVA|||Community Integration Questionnaire||0.8|-1.3|0.4
72459606|NCT01358175|144442220|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.76|||<|0.0001|TWO_SIDED|95.0|2.2|6.42|||Regression, Logistic|||||6.42|2.20|<0.0001
72459607|NCT01358175|144442220|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.89|||<|0.0001|TWO_SIDED|95.0|2.28|6.65|||Regression, Logistic|||||6.65|2.28|<0.0001
72501050|NCT01381094|144532152|SUPERIORITY||||||=|0.0654|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 6).||||=0.0654
72501051|NCT01381094|144532152|SUPERIORITY||||||=|0.4169|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 6).||||=0.4169
72501052|NCT01381094|144532152|SUPERIORITY||||||=|0.0103|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 6).||||=0.0103
72501053|NCT01381094|144532152|SUPERIORITY||||||=|0.3968|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 6).||||=0.3968
72501054|NCT01381094|144532152|SUPERIORITY||||||=|0.0325|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).||||=0.0325
72501055|NCT01381094|144532152|SUPERIORITY||||||=|0.2151|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).||||=0.2151
72501056|NCT01381094|144532152|SUPERIORITY||||||=|0.8436|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).||||=0.8436
72459608|NCT02379078|144442233|SUPERIORITY|||||||0.0246|TWO_SIDED|95.0|||||Mixed Models Analysis|||||||0.0246
72459609|NCT02379078|144442234|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||||||<0.0001
72459610|NCT02379078|144442235|SUPERIORITY|||||||0.12|||||||Mixed Models Analysis|||||||0.12
72459611|NCT02379078|144442236|SUPERIORITY|||||||0.468|||||||Mixed Models Analysis|||||||0.468
72459612|NCT02379078|144442237|SUPERIORITY|||||||0.6|||||||ANOVA|||||||0.60
72459613|NCT04908488|144442238|NON_INFERIORITY|Noninferiority in distance VA was declared if upper confidence limit was less than 0.05.|Least Squares Means Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.004|||ONE_SIDED|95.0||-0.01|||Mixed effects repeated measures model|Within subject correlation due to eye and the crossover design were accounted for in the model.|Lens difference (P1fA minus AMfA)|||-0.01||
72459614|NCT01107912|144442244|NON_INFERIORITY_OR_EQUIVALENCE|The difference of median MPA to 20 μM ADP of a prasugrel 5-mg in the elderly group to the 75th percentile of the MPA to 20 μM ADP of a prasugrel 10 mg MD in the non-elderly group at the end of Period 1 was estimated from the observed data. The upper limit of the one-sided 97.5% confidence interval for the difference was estimated from resampling data with replacement through bootstrap methodology and was used to compare with the non-inferiority margin of 15 percentage points.|Estimate of the difference|6.0|||||TWO_SIDED|95.0|1.0|9.0||||||||9.00|1.00|
72459615|NCT01124916|144442259|SUPERIORITY_OR_OTHER||Mean Difference (Net)|8728.0|STANDARD_ERROR_OF_MEAN|853.129|<|0.001|TWO_SIDED|95.0|7028.846|10427.154|||t-test, 2 sided|||The null hypothesis is that there is no difference in the total cost of care between standard and robotic-assisted laparoscopic abdominal sacrocolpopexy six weeks after surgery.||10427.154|7028.846|<.001
72459616|NCT01124916|144442260|SUPERIORITY_OR_OTHER||Mean Difference (Net)|6.2|STANDARD_ERROR_OF_MEAN|7.846||0.43|TWO_SIDED|95.0|-21.769|9.369|||t-test, 2 sided|||The null hypothesis is that there is no difference in urinary distress between women assigned to LASC and those assigned to RASC six months after intervention as measured by the UDI.||9.369|-21.769|.43
72459617|NCT03014726|144442265|OTHER|Recurrence \< 0.5 as defined by an IPSS score of less than or equal to 11. The performance goal is met if the upper limit of the one-sided 95% confidence interval for recurrence is less than 50%.|||||<|0.001|||||||1-sample binomial z-test|||||||<0.001
72459618|NCT00901459|144442266|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.47|STANDARD_ERROR_OF_MEAN|0.44||0.014|TWO_SIDED|95.0|0.51|2.43||A Holm correction to p values was made to control for type 1 error.|t-test, 2 sided|df=14|The parameter estimated is the difference in craving change between smoking cues and neutral cues in the 10Hz sfg condition (Frequency control)and the corresponding craving change in the 1Hz sfg condition (active).|A pairwise t-test was performed to contrast the active rTMS condition with the frequency control condition.||2.43|0.51|0.014
72459619|NCT00901459|144442266|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.29|STANDARD_ERROR_OF_MEAN|0.4||0.49|TWO_SIDED|95.0|-0.64|1.22|||t-test, 2 sided|df=13|The parameter estimated is the difference in craving change between smoking cues and neutral cues in the 1Hz sfg condition (active)and the corresponding craving change in the 1Hz moc condition (location control).|A pairwise t-test was performed to contrast the active rTMS condition with the location control condition.||1.22|-0.64|0.49
72459620|NCT00901459|144442266|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.95|STANDARD_ERROR_OF_MEAN|0.44||0.09|TWO_SIDED|95.0|0.52|1.39||A Holm correction to p values was made to control for type 1 error.|t-test, 2 sided|df=13|The parameter estimated is the difference in craving change between smoking cues and neutral cues in the 10Hz sfg condition (frequency control)and the corresponding craving change in the 1Hz moc condition (location control).|A pairwise t-test was performed to contrast the location control rTMS condition with the frequency control condition.||1.39|0.52|0.09
72459621|NCT00848198|144442273|SUPERIORITY_OR_OTHER||Sensitivity|87.1|||||TWO_SIDED|95.0|83.2|90.9||||||||90.9|83.2|
72459622|NCT00848198|144442273|SUPERIORITY_OR_OTHER||Specificity|72.0|||||TWO_SIDED|95.0|66.9|77.1||||||||77.1|66.9|
72459623|NCT00848198|144442274|SUPERIORITY_OR_OTHER||Sensitivity|39.7|||||TWO_SIDED|95.0|34.2|45.3||||||||45.3|34.2|
72459624|NCT00848198|144442274|SUPERIORITY_OR_OTHER||Specificity|82.7|||||TWO_SIDED|95.0|78.4|87.0||||||||87.0|78.4|
72459625|NCT00848198|144442275|SUPERIORITY_OR_OTHER||Sensitivity|71.9|||||TWO_SIDED|95.0|66.8|77.0||||||||77.0|66.8|
72459626|NCT00848198|144442275|SUPERIORITY_OR_OTHER||Specificity|82.7|||||TWO_SIDED|95.0|78.4|87.0||||||||87.0|78.4|
72459627|NCT00848198|144442276|SUPERIORITY_OR_OTHER||Sensitivity|27.2|||||TWO_SIDED|95.0|22.2|32.3||||||||32.3|22.2|
72459628|NCT00848198|144442276|SUPERIORITY_OR_OTHER||Specificity|98.7|||||TWO_SIDED|95.0|97.4|100.0||||||||100.0|97.4|
72459629|NCT00848198|144442277|SUPERIORITY_OR_OTHER||Sensitivity|51.3|||||TWO_SIDED|95.0|45.7|57.0||||||||57.0|45.7|
72459630|NCT00848198|144442277|SUPERIORITY_OR_OTHER||Specificity|94.7|||||TWO_SIDED|95.0|92.1|97.2||||||||97.2|92.1|
72459631|NCT00848198|144442278|SUPERIORITY_OR_OTHER||Sensitivity|61.2|||||TWO_SIDED|95.0|55.6|66.7||||||||66.7|55.6|
72459632|NCT00848198|144442278|SUPERIORITY_OR_OTHER||Specificity|78.7|||||TWO_SIDED|95.0|74.0|83.3||||||||83.3|74.0|
72459633|NCT00848198|144442279|SUPERIORITY_OR_OTHER||Sensitivity|58.5|||||TWO_SIDED|95.0|52.9|64.1||||||||64.1|52.9|
72459634|NCT00848198|144442279|SUPERIORITY_OR_OTHER||Specificity|73.3|||||TWO_SIDED|95.0|68.3|78.3||||||||78.3|68.3|
72459635|NCT03905512|144442291|SUPERIORITY|Statistical significance was tested at a level of 0.05.||||||0.181|||||||Cochran-Mantel-Haenszel|||||||0.181
72459636|NCT00866619|144442309|SUPERIORITY|Criterion for success = lower limit (LL) of 97.5% confidence interval (CI) of VE \> 0.|Vaccine efficacy|55.8|||<|0.0001|TWO_SIDED|97.5|50.6|60.4|||Regression, Cox|||The analysis aimed to compare RfoCPFMI between groups over the Months 2.5-14 time period. Using RfoCFPMI, a Cox regression model was used to evaluate vaccine efficacy (VE) allowing for adjustment by factors. VE was calculated as 1 minus \[Hazard Ratio (HR) in GSK257049 \[5-17M\] Group (HR1) divided by HR in control VeroRab Comparator \[5-17M\] Group (HR2)\]; i. e. 1 - (HR1/HR2).||60.4|50.6|<0.0001
72459637|NCT00866619|144442310|SUPERIORITY|Point estimate of efficacy was adjusted for study site as stratification factor for the analysis. Criterion for success = lower limit (LL) of 97.5% confidence interval (CI) of VE \> 0.|Vaccine efficacy|31.315|||<|0.0001|TWO_SIDED|97.5|23.556|38.286|||Regression, Cox|||The analysis aimed to compare RfoCPFMI between groups over the Months 2.5-14 time period. Using RfoCFPMI, a Cox regression model was used to evaluate vaccine efficacy (VE) allowing for adjustment by factors. VE was calculated as 1 minus \[Hazard Ratio (HR) in GSK257049 \[6-12W\] Group (HR1) divided by HR in control Menjugate Comparator \[6-12W\] Group (HR2)\]; i. e. 1 - (HR1/HR2).||38.286|23.556|<0.0001
72459638|NCT00645411|144442376|NON_INFERIORITY_OR_EQUIVALENCE|Cell derived vaccine was considered non-inferior to egg-derived vaccine in post vaccination HI GMTs if, for all three influenza strains, the lower limit of the two-sided 95% confidence interval (CI) for day 50 ratio of GMTs (cTIV/eTIV) was \>0.667.|Ratio of GMTs|0.85|||||TWO_SIDED|95.0|0.72|1.01|||ANOVA|||Non-inferiority of cTIV to eTIV against A/H1N1 influenza strain as measured by HI egg-derived antigen assay||1.01|0.72|
72501057|NCT01381094|144532152|SUPERIORITY||||||=|0.5962|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).||||=0.5962
72501058|NCT01381094|144532152|SUPERIORITY||||||=|0.3957|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).||||=0.3957
72501059|NCT01381094|144532153|SUPERIORITY||||||=|0.0294|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 2).||||=0.0294
72501060|NCT01381094|144532153|SUPERIORITY||||||=|0.0021|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 2).||||=0.0021
72459639|NCT00645411|144442376|NON_INFERIORITY_OR_EQUIVALENCE|Cell derived vaccine (cTIV ) was considered non-inferior to egg-derived vaccine (eTIV) in postvaccination HI GMTs if, for all three influenza strains, the lower limit of the two-sided 95% confidence interval (CI) for day 50 ratio of GMTs(cTIV/eTIV) was \>0.667.|Ratio of GMTs|0.59|||||TWO_SIDED|95.0|0.49|0.72|||ANOVA|||Non-inferiority of cTIV to eTIV against A/H3N2 influenza strain as measured by HI egg-derived antigen assay.||0.72|0.49|
72459640|NCT00645411|144442376|NON_INFERIORITY_OR_EQUIVALENCE|Cell derived vaccine (cTIV ) was considered non-inferior to egg-derived vaccine (eTIV)in post vaccination HI GMTs if, for all three influenza strains, the lower limit of the two-sided 95% confidence interval (CI) for day 50 ratio of GMTs (cTIV/eTIV) was \>0.667.|Ratio of GMTs|0.56|||||TWO_SIDED|95.0|0.46|0.68|||ANOVA|||Non-inferiority of cTIV to eTIV against influenza B strain as measured by HI egg-derived antigen assay.||0.68|0.46|
72459641|NCT00645411|144442376|NON_INFERIORITY_OR_EQUIVALENCE|Cell derived vaccine (cTIV) was considered non-inferior to egg-derived vaccine (eTIV) in post vaccination HI GMTs if, for all three influenza strains, the lower limit of the two-sided 95% confidence interval (CI) for day 50 ratio of GMTs (cTIV/eTIV) was \>0.667.|Ratio of GMTs|0.92|||||TWO_SIDED|95.0|0.79|1.08|||ANOVA|||Non-inferiority of cTIV to eTIV against A/H1N1 influenza strain as measured by HI cell-derived antigen assay.||1.08|0.79|
72459642|NCT00645411|144442376|NON_INFERIORITY_OR_EQUIVALENCE|Cell derived vaccine (cTIV) was considered non-inferior to egg-derived vaccine (eTIV)in post vaccination HI GMTs if, for all three influenza strains, the lower limit of the two-sided 95% confidence interval (CI) for day 50 ratio of GMTs (cTIV/eTIV) was \>0.667.|Ratio of GMTs|0.65|||||TWO_SIDED|95.0|0.54|0.78|||ANOVA|||Non-inferiority of cTIV to eTIV against A/H3N2 influenza strain as measured by HI cell-derived antigen assay.||0.78|0.54|
72459643|NCT00645411|144442376|NON_INFERIORITY_OR_EQUIVALENCE|Cell derived vaccine (cTIV) was considered non-inferior to egg-derived vaccine (eTIV)in post vaccination HI GMTs if, for all three influenza strains, the lower limit of the two-sided 95% confidence interval (CI) for day 50 ratio of GMTs (cTIV/eTIV)was \>0.667.|Ratio of GMTs|0.87|||||TWO_SIDED|95.0|0.71|1.06|||ANOVA|||Non-inferiority of cTIV to eTIV against B influenza strain as measured by HI cell-derived antigen assay.||1.06|0.71|
72459644|NCT00645411|144442377|NON_INFERIORITY_OR_EQUIVALENCE|cTIV was considered non-inferior to eTIV in terms of the percentages of subjects achieving seroconversion or significant increase in antibody titer at day 50 if for all three strains, the lower limit of the two-sided 95% CI around the differences in the percentages of subjects achieving seroconversion and significant increase (cTIV minus eTIV) was \>-10%.|Difference in % (cTIV minus eTIV)|-1.0|||||TWO_SIDED|95.0|-4.0|1.0|||binomial or the method of Miettinen and|||Non-inferiority of cTIV to eTIV against A/H1N1 influenza strain as measured by HI egg-derived antigen assay.||1|-4|
72459645|NCT00645411|144442377|NON_INFERIORITY_OR_EQUIVALENCE|cTIV was considered non-inferior to eTIV in terms of the percentages of subjects achieving seroconversion or significant increase in antibody titer at day 50 if for all three strains, the lower limit of the two-sided 95% CI around the differences in the percentages of subjects achieving seroconversion and significant increase (cTIV minus eTIV) was \>-10%.|Difference % (cTIV - eTIV)|-9.0|||||TWO_SIDED|95.0|-13.0|-4.0|||binomial or Miettinen & Nurimen method|||Non-inferiority of cTIV to eTIV against A/H3N2 influenza strain as measured by HI egg-derived antigen assay.||-4|-13|
72459646|NCT00645411|144442377|NON_INFERIORITY_OR_EQUIVALENCE|cTIV was considered non-inferior to eTIV in terms of the percentages of subjects achieving seroconversion or significant increase in antibody titer at day 50 if for all three strains, the lower limit of the two-sided 95% CI around the differences in the percentages of subjects achieving seroconversion and significant increase (cTIV minus eTIV) was \>-10%.|Difference % (cTIV minus eTIV)|-15.0|||||TWO_SIDED|95.0|-21.0|-9.0|||binominal or Miettinen &Nurimen method|||Non-inferiority of cTIV to eTIV against B influenza strain as measured by HI egg-derived antigen assay.||-9|-21|
72459647|NCT00645411|144442377|NON_INFERIORITY_OR_EQUIVALENCE|cTIV was considered non-inferior to eTIV in terms of the percentages of subjects achieving seroconversion or significant increase in antibody titer at day 50 if for all three strains, the lower limit of the two-sided 95% CI around the differences in the percentages of subjects achieving seroconversion and significant increase (cTIV minus eTIV) was \>-10%|Difference % (cTIV minus eTIV)|-1.0|||||TWO_SIDED|95.0|-3.0|2.0|||binominal or Miettinen &Nurimen method|||Non-inferiority of cTIV to eTIV against A/H1N1 influenza strain as measured by HI cell-derived antigen assay.||2|-3|
72459648|NCT00645411|144442377|NON_INFERIORITY_OR_EQUIVALENCE|cTIV was considered non-inferior to eTIV in terms of the percentages of subjects achieving seroconversion or significant increase in antibody titer at day 50 if for all three strains, the lower limit of the two-sided 95% CI around the differences in the percentages of subjects achieving seroconversion and significant increase (cTIV minus eTIV) was \>-10%.|Difference % (cTIV minus eTIV)|-5.0|||||TWO_SIDED|95.0|-9.5|0.0|||binominal or Miettinen &Nurimen method|||Non-inferiority of cTIV to eTIV against A/H3N2 influenza strain as measured by HI cell-derived antigen assay.||0|-9.5|
72459649|NCT00645411|144442377|NON_INFERIORITY_OR_EQUIVALENCE|cTIV was considered non-inferior to eTIV in terms of the percentages of subjects achieving seroconversion or significant increase in antibody titer at day 50 if for all three strains, the lower limit of the two-sided 95% CI around the differences in the percentages of subjects achieving seroconversion and significant increase (cTIV minus eTIV) was \>-10%.|Difference % (cTIV minus eTIV)|0.0|||||TWO_SIDED|95.0|-6.0|6.0|||binominal or Miettinen &Nurimen method|||Non-inferiority of cTIV to eTIV against B influenza strain as measured by HI cell-derived antigen assay.||6|-6|
72563238|NCT00442546|144658162|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.154|STANDARD_ERROR_OF_MEAN|0.327||0.6386||95.0|-0.799|0.491|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET||0.491|-0.799|0.6386
72563239|NCT00442546|144658162|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.702|STANDARD_ERROR_OF_MEAN|0.397||0.0813||95.0|-1.493|0.089|||ANOVA||Mean difference (final values) = Least squares mean difference|Month 3||0.089|-1.493|0.0813
72563240|NCT00442546|144658162|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.378|STANDARD_ERROR_OF_MEAN|0.37||0.31||95.0|-1.114|0.358|||ANOVA||Mean difference (final values) = Least squares mean difference|Month 3||0.358|-1.114|0.3100
72459650|NCT05062343|144442394|SUPERIORITY|||||||0.91|||||||Wilcoxon (Mann-Whitney)|||||||0.91
72459651|NCT05062343|144442395|SUPERIORITY||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||||||<0.01
72459652|NCT05062343|144442396|SUPERIORITY|||||||1|||||||Chi-squared|||||||1.0
72459653|NCT05062343|144442397|SUPERIORITY|||||||0.89|||||||Wilcoxon (Mann-Whitney)|||||||0.89
72620960|NCT00452400|144772844|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.09|STANDARD_ERROR_OF_MEAN|0.043||0.0376||95.0|0.005|0.174|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 20 mcg qd minus Placebo|||0.174|0.005|0.0376
72620961|NCT00452400|144772845|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.705|STANDARD_ERROR_OF_MEAN|5.916||0.0211|TWO_SIDED|95.0|2.07|25.34|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 2 mcg qd minus Placebo|||25.340|2.070|0.0211
72459654|NCT05062343|144442398|SUPERIORITY|||||||0.98|||||||Wilcoxon (Mann-Whitney)|||||||0.98
72459655|NCT05062343|144442399|SUPERIORITY|||||||0.045|||||||Chi-squared|||||||0.045
72459656|NCT05062343|144442400|SUPERIORITY|||||||1|||||||Chi-squared|||||||1
72459657|NCT05062343|144442401|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1
72459658|NCT02138838|144442419|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|8.1||||0.48|TWO_SIDED|95.0|-13.7|29.9|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by baseline age group|SOC+Cinacalcet - SOC|||29.9|-13.7|0.48
72459659|NCT02138838|144442420|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|-9.9||||0.42|TWO_SIDED|95.0|-33.3|13.4|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel stratified by baseline age group (6-\<12 years, 12-\<18 years)|SOC+Cinacalcet - SOC|A hierarchical testing procedure was used to test the primary and biochemical secondary endpoints. The primary endpoint was tested at a 2-sided significance level of 0.05. The secondary endpoints were tested using Holm's method at 0.05 (2-sided) should the primary endpoint achieve a significant result.||13.4|-33.3|0.42
72459660|NCT02138838|144442421|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|-10.4||||0.25|TWO_SIDED|95.0|-27.7|6.8|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by baseline age group|SOC+Cinacalcet - SOC|||6.8|-27.7|0.25
72459661|NCT02138838|144442422|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|19.0||||0.23|TWO_SIDED|95.0|-12.5|50.5|||ANCOVA|Analysis of covariance (ANCOVA) with baseline age group as the covariate.|SOC+Cinacalcet - SOC|||50.5|-12.5|0.23
72459662|NCT02138838|144442423|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|-0.34||||0.059|TWO_SIDED|95.0|-0.7|0.01|||ANCOVA|Analysis of covariance (ANCOVA) with baseline age group as the covariate.||||0.01|-0.70|0.059
72620962|NCT00452400|144772845|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|21.285|STANDARD_ERROR_OF_MEAN|5.951||0.0004|TWO_SIDED|95.0|9.581|32.99|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 5 mcg qd minus Placebo|||32.990|9.581|0.0004
72370522|NCT00488683|144251632|SUPERIORITY_OR_OTHER||R-square|0.07||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one month after booster vaccination for the serogroup W-135||||
72620963|NCT00452400|144772845|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|38.077|STANDARD_ERROR_OF_MEAN|5.832|<|0.0001|TWO_SIDED|95.0|26.607|49.546|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 10 mcg qd minus Placebo|||49.546|26.607|<.0001
72620964|NCT00452400|144772845|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|23.063|STANDARD_ERROR_OF_MEAN|5.99||0.0001|TWO_SIDED|95.0|11.282|34.845|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 20 mcg qd minus Placebo|||34.845|11.282|0.0001
72459663|NCT02138838|144442424|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|0.76||||0.039|TWO_SIDED|95.0|0.04|1.48|||ANCOVA|Analysis of covariance (ANCOVA) with baseline age group as the covariate.|SOC+Cinacalcet - SOC|||1.48|0.04|0.039
72459664|NCT00780741|144442425|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||0.09|TWO_SIDED|95.0|-0.01|0.21|||Point estimate on mean difference|Bootstrap sampling with replacement (N=10,000) was used to calculate the 95% confidence interval.|Mean difference calculated as the proportion with success in immediate group minus proportion with success in deferred group. 95% confidence interval obtained using bootstrap sampling with replacement.|||0.21|-0.01|0.09
72459665|NCT00780741|144442426|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-139.0||||0.24|TWO_SIDED|95.0|-377.0|94.0|||Point estimate on mean difference|Bootstrap sampling with replacement (N=10,000) was used to calculate the 95% confidence interval.|Mean difference calculated as the average cost in immediate group minus average cost in deferred group. 95% confidence interval obtained using bootstrap sampling with replacement.|||94|-377|0.24
72459666|NCT00780741|144442427|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.0|||<|0.0001|TWO_SIDED|95.0|-4.0|-1.8|||Point estimate on mean difference|Bootstrap sampling with replacement (N=10,000) was used to calculate the 95% confidence interval.|Mean difference calculated as the average months of symptoms in immediate group minus average months of symptoms in deferred group. 95% confidence interval obtained using bootstrap sampling with replacement.|||-1.8|-4.0|<0.0001
72459667|NCT01867307|144442454|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-220.0|STANDARD_ERROR_OF_MEAN|55.5|<|0.0001|TWO_SIDED|95.0|-440.6|-202.7||P-value is from a paired t-test.|Paired t- test||Difference calculated as (Day 14 - baseline) values|Point estimates of the changes from baseline and 95% Confidence interval around the estimates on treatment day 14 were computed.||-202.7|-440.6|<0.0001
72459668|NCT01867307|144442454|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-234.0|STANDARD_ERROR_OF_MEAN|25.8|<|0.0001|TWO_SIDED|95.0|-312.3|-201.5||P-value is from a paired t-test|Paired t-test||Difference calculated as (Day 14 - baseline) values|Point estimates of the changes from baseline and 95% Confidence interval around the estimates on treatment day 14 were computed.||-201.5|-312.3|<0.0001
72459669|NCT00623714|144442466|SUPERIORITY_OR_OTHER||Geometric Mean Fold Difference|0.34||||0.011|TWO_SIDED|90.0|0.16|0.7||1-sided, alpha = 0.05|ANOVA|Analysis performed on log-transformed fold change from baseline and results were back-transformed for reporting.||||0.70|0.16|0.011
72459670|NCT00623714|144442467|SUPERIORITY_OR_OTHER||Geometric Mean Fold Difference|0.4||||0.002|TWO_SIDED|95.0|0.26|0.63||1-sided, alpha = 0.05|ANOVA|Analysis performed on log-transformed fold change from baseline and results were back-transformed for reporting.||||0.63|0.26|0.002
72459671|NCT00760877|144442468|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.096||||0.1083|TWO_SIDED|95.0|0.766|5.738|||Cochran-Mantel-Haenszel|||||5.738|0.766|0.1083
72459672|NCT04694300|144442490|SUPERIORITY|Lower the maximum pain intensity score the more effective the analgesic|||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
72459673|NCT04694300|144442491|SUPERIORITY||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
72459674|NCT04694300|144442492|SUPERIORITY|||||||0.12|||||||Wilcoxon (Mann-Whitney)|||||||0.12
72392513|NCT01652703|144292430|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-29.82|STANDARD_ERROR_OF_MEAN|9.36||0.002|TWO_SIDED|95.0|-48.32|-11.32||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factor of screening LDL-C level.|Placebo is the reference|||-11.32|-48.32|0.002
72392514|NCT01652703|144292430|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-20.82|STANDARD_ERROR_OF_MEAN|9.41||0.028|TWO_SIDED|95.0|-39.41|-2.22||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factor of screening LDL-C level.|Placebo is the reference|||-2.22|-39.41|0.028
72392515|NCT01652703|144292431|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-46.98|STANDARD_ERROR_OF_MEAN|2.64|<|0.001|TWO_SIDED|95.0|-52.21|-41.76||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factor of screening LDL-C level.|Placebo is the reference|||-41.76|-52.21|<0.001
72459675|NCT04694300|144442493|SUPERIORITY||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
72459676|NCT04694300|144442496|SUPERIORITY|||||||0.29|||||||Wilcoxon (Mann-Whitney)|||||||0.29
72459677|NCT04694300|144442497|SUPERIORITY||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
72459678|NCT04694300|144442498|SUPERIORITY|||||||0.59|||||||Wilcoxon (Mann-Whitney)|Higher percentage inhibition relates to greater selectivity for COX-2||||||0.59
72459679|NCT04694300|144442499|SUPERIORITY|||||||0.14|||||||Wilcoxon (Mann-Whitney)|||||||0.14
72459680|NCT01263223|144442513|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.7|||<|0.0001|TWO_SIDED|95.0|7.4|12.0||P-value is for the Mean Change in ABPM heart rate.|Mixed Models Analysis|||||12.0|7.4|<0.0001
72459681|NCT01263223|144442513|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|24.4|||<|0.0001|TWO_SIDED|95.0|17.9|30.9||P-value is for the Maximum Change in ABPM heart rate.|Mixed Models Analysis|||||30.9|17.9|<0.0001
72501061|NCT01381094|144532153|SUPERIORITY||||||=|0.0004|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 2).||||=0.0004
72392516|NCT01652703|144292431|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-37.22|STANDARD_ERROR_OF_MEAN|2.68|<|0.001|TWO_SIDED|95.0|-42.52|-31.91||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factor of screening LDL-C level.|Placebo is the reference|||-31.91|-42.52|<0.001
72392517|NCT01652703|144292431|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-46.66|STANDARD_ERROR_OF_MEAN|2.86|<|0.001|TWO_SIDED|95.0|-52.32|-41.0||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factor of screening LDL-C level.|Placebo is the reference|||-41.00|-52.32|<0.001
72563241|NCT00442546|144658162|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.831|STANDARD_ERROR_OF_MEAN|0.357||0.0231||95.0|0.118|1.545|||ANOVA||Mean difference (final values) = Least squares mean difference|Month 6||1.545|0.118|0.0231
72392518|NCT01652703|144292431|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-45.3|STANDARD_ERROR_OF_MEAN|2.89|<|0.001|TWO_SIDED|95.0|-51.02|-39.58||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factor of screening LDL-C level.|Placebo is the reference|||-39.58|-51.02|<0.001
72392519|NCT01652703|144292432|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-61.35|STANDARD_ERROR_OF_MEAN|2.93|<|0.001|TWO_SIDED|95.0|-67.14|-55.56||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factor of screening LDL-C level.|Placebo is the reference|||-55.56|-67.14|<0.001
72392520|NCT01652703|144292432|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-47.53|STANDARD_ERROR_OF_MEAN|2.98|<|0.001|TWO_SIDED|95.0|-53.41|-41.65||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factor of screening LDL-C level.|Placebo is the reference|||-41.65|-53.41|<0.001
72459682|NCT01263223|144442514|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.3|||<|0.0001|TWO_SIDED|95.0|3.9|8.8||P-value is for the Mean Change in ABPM systolic BP.|Mixed Models Analysis|||||8.8|3.9|<0.0001
72459683|NCT01263223|144442514|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.1||||0.0025|TWO_SIDED|95.0|2.6|11.6||P-value is for the Maximum Change in ABPM systolic BP.|Mixed Models Analysis|||||11.6|2.6|0.0025
72459684|NCT01263223|144442514|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.51|||<|0.0001|TWO_SIDED|95.0|3.81|7.21||P-value is for the Mean Change in ABPM diastolic BP.|Mixed Models Analysis|||||7.21|3.81|<0.0001
72459685|NCT01263223|144442514|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.66||||0.002|TWO_SIDED|95.0|2.13|9.2||P-value is for the Maximum Change in ABPM diastolic BP.|Mixed Models Analysis|||||9.20|2.13|0.0020
72459686|NCT01263223|144442515|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.9||||0.0224|TWO_SIDED|95.0|0.418|5.38||P-value is for the Mean Change in ABPM systolic BP.|Mixed Models Analysis|||||5.38|0.418|0.0224
72459687|NCT01263223|144442515|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.7||||0.2453|TWO_SIDED|95.0|-1.88|7.29||P-value is for the Maximum Change in ABPM systolic BP.|Mixed Models Analysis|||||7.29|-1.88|0.2453
72459688|NCT01263223|144442515|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.1|||<|0.0001|TWO_SIDED|95.0|3.37|6.82||P-value if for the Mean Change in ABPM diastolic BP.|Mixed Models Analysis|||||6.82|3.37|<0.0001
72459689|NCT01263223|144442515|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.53||||0.0005|TWO_SIDED|95.0|2.95|10.1||P-value is for the Maximum Change in ABPM diastolic BP.|Mixed Models Analysis|||||10.1|2.95|0.0005
72459690|NCT01263223|144442516|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.8|||<|0.0001|TWO_SIDED|95.0|8.7|16.9||P-value is for the Mean Change in ABPM heart rate.|Mixed Models Analysis|||||16.9|8.7|<0.0001
72459691|NCT01263223|144442516|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|23.0||||0.0001|TWO_SIDED|95.0|11.4|34.5||P-value is for the Maximum Change in ABPM heart rate.|Mixed Models Analysis|||||34.5|11.4|0.0001
72459692|NCT01263223|144442517|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.8||||0.212|TWO_SIDED|95.0|-1.6|7.2||P-value is for the Mean Change in ABPM Systolic BP.|Mixed Models Analysis|||||7.2|-1.6|0.2120
72459693|NCT01263223|144442517|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.6||||0.064|TWO_SIDED|95.0|-0.4|15.5||P-value is for the Maximum Change in ABPM Systolic BP.|Mixed Models Analysis|||||15.5|-0.4|0.0640
72459694|NCT01263223|144442517|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.6||||0.0211|TWO_SIDED|95.0|0.5|6.7||P-value is for the Mean Change in ABPM Diastolic BP.|Mixed Models Analysis|||||6.7|0.5|0.0211
72392521|NCT01652703|144292432|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-57.75|STANDARD_ERROR_OF_MEAN|3.03|<|0.001|TWO_SIDED|95.0|-63.73|-51.77||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factor of screening LDL-C level.|Placebo is the reference|||-51.77|-63.73|<0.001
72459695|NCT01263223|144442517|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.5||||0.8719|TWO_SIDED|95.0|-5.7|6.8||P-value is for the Maximum Change in ABPM Diastolic BP.|Mixed Models Analysis|||||6.8|-5.7|0.8719
72459696|NCT01263223|144442518|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8||||0.7133|TWO_SIDED|95.0|-5.3|3.7||P-value is for the Mean Change in ABPM heart rate.|Mixed Models Analysis|||||3.7|-5.3|0.7133
72459697|NCT01263223|144442518|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.7||||0.4638|TWO_SIDED|95.0|-17.2|7.9||P-value is for the Maximum Change in ABPM heart rate.|Mixed Models Analysis|||||7.9|-17.2|0.4638
72459698|NCT01263223|144442519|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.6|||<|0.0001|TWO_SIDED|95.0|11.3|15.9||P-value is for the Mean Change in ABPM heart rate.|Mixed Models Analysis|||||15.9|11.3|<0.0001
72501062|NCT01381094|144532153|SUPERIORITY||||||=|0.0001|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 2).||||=0.0001
72501063|NCT01381094|144532153|SUPERIORITY||||||=|0.0925|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 2).||||=0.0925
72501064|NCT01381094|144532153|SUPERIORITY||||||=|0.0433|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 4).||||=0.0433
72501065|NCT01381094|144532153|SUPERIORITY||||||<|0.0001|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 4).||||<0.0001
72563242|NCT00442546|144658162|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.463|STANDARD_ERROR_OF_MEAN|0.388||0.2367||95.0|-0.311|1.237|||ANOVA||Mean difference (final values) = Least squares mean difference|Month 6||1.237|-0.311|0.2367
72459699|NCT01263223|144442519|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|27.6|||<|0.0001|TWO_SIDED|95.0|21.1|34.2||P-value is for the Maximum Change in ABPM heart rate.|Mixed Models Analysis|||||34.2|21.1|<0.0001
72459700|NCT01263223|144442520|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.9609|TWO_SIDED|95.0|-4.9|4.7||P-value is for the Mean Change in ABPM Systolic BP.|Mixed Models Analysis|||||4.7|-4.9|0.9609
72563243|NCT00442546|144658163|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.064|STANDARD_ERROR_OF_MEAN|0.448||0.8868||95.0|-0.947|0.82|||ANOVA||Mean difference (final values) = Least squares mean difference|Discharge||0.820|-0.947|0.8868
72563244|NCT00442546|144658163|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.254|STANDARD_ERROR_OF_MEAN|0.45||0.5733||95.0|-1.142|0.634|||ANOVA||Mean difference (final values) = Least squares mean difference|Discharge||0.634|-1.142|0.5733
72459701|NCT01263223|144442520|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.8||||0.2731|TWO_SIDED|95.0|-3.9|13.6||P-value is for the Maximum Change in ABPM Systolic BP.|Mixed Models Analysis|||||13.6|-3.9|0.2731
72459702|NCT01263223|144442520|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.5||||0.3779|TWO_SIDED|95.0|-4.8|1.8||P-value is for the Mean Change in ABPM Diastolic BP.|Mixed Models Analysis|||||1.8|-4.8|0.3779
72459703|NCT01263223|144442520|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.0||||0.0828|TWO_SIDED|95.0|-12.8|0.8||P-value is for the Maximum Change in ABPM Diastolic BP.|Mixed Models Analysis|||||0.8|-12.8|0.0828
72459704|NCT01322347|144442521|SUPERIORITY_OR_OTHER||Difference in LS Means between SFP & PBO|3.6|STANDARD_ERROR_OF_MEAN|1.39||0.011|TWO_SIDED|95.0||||LS Mean (SE) and p-value are from ANCOVA model with baseline Hgb as covariate. Model also includes indicator variable for baseline ESA dose stratum.|ANCOVA|||||||0.011
72459705|NCT00896389|144442536|OTHER|Association between genotypes and phenotypes were tested using a linear mixed model, coding genotype as an independent variable with an additive genetic effect, and including age, age\^2, and sex as covariates in the model. All association analyses were run using the Mixed Models for Pedigree Analysis (MMAP) software program to account for the relatedness among study subjects. MMAP User Guide is available from http://edn.som.umaryland.edu/mmap/index.php.|||||>|0.05||||||Because no P-values less than 0.05 was observed, we did not adjust them for multiple comparison to avoid false positives.|Chi-squared|||Null hypothesis: There is no association between STK39 SNP rs35929607 genotype group and phenotypes collected in this study.||||>0.05
72459706|NCT00896389|144442537|OTHER|Association between genotype and phenotype were tested using a linear mixed model, coding genotype as an independent variable with an additive genetic effect, and including age, age\^2, and sex as covariates in the model. All association analyses were run using the Mixed Models for Pedigree Analysis (MMAP) software program to account for the relatedness among study subjects. MMAP User Guide is available from http://edn.som.umaryland.edu/mmap/index.php.|||||<|0.05||||||Because no P-values less than 0.05 was observed, we did not adjust them for multiple comparison to avoid false positives.|Chi-squared|||||||<0.05
72501066|NCT01381094|144532153|SUPERIORITY||||||=|0.0005|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 4).||||=0.0005
72501067|NCT01381094|144532153|SUPERIORITY||||||<|0.0001|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 4).||||<0.0001
72501068|NCT01381094|144532153|SUPERIORITY||||||=|0.1626|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 4).||||=0.1626
72392522|NCT01652703|144292432|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-52.22|STANDARD_ERROR_OF_MEAN|3.06|<|0.001|TWO_SIDED|95.0|-58.27|-46.18||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factor of screening LDL-C level.|Placebo is the reference|||-46.18|-58.27|<0.001
72563245|NCT00442546|144658163|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.128|STANDARD_ERROR_OF_MEAN|0.384||0.7385||95.0|-0.884|0.628|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2||0.628|-0.884|0.7385
72563246|NCT00442546|144658163|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.081|STANDARD_ERROR_OF_MEAN|0.39||0.8353||95.0|-0.849|0.687|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2||0.687|-0.849|0.8353
72563247|NCT00442546|144658163|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.204|STANDARD_ERROR_OF_MEAN|0.362||0.5737||95.0|-0.51|0.918|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4||0.918|-0.510|0.5737
72563248|NCT00442546|144658163|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.335|STANDARD_ERROR_OF_MEAN|0.368||0.364||95.0|-1.06|0.391|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4||0.391|-1.060|0.3640
72563249|NCT00442546|144658163|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.262|STANDARD_ERROR_OF_MEAN|0.332||0.4315||95.0|-0.393|0.917|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET||0.917|-0.393|0.4315
72563250|NCT00442546|144658163|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.143|STANDARD_ERROR_OF_MEAN|0.339||0.6727||95.0|-0.525|0.812|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET||0.812|-0.525|0.6727
72459707|NCT00896389|144442538|OTHER|Association between genotype and phenotype were tested using a linear mixed model, coding genotype as an independent variable with an additive genetic effect, and including age, age\^2, and sex as covariates in the model. All association analyses were run using the Mixed Models for Pedigree Analysis (MMAP) software program to account for the relatedness among study subjects. MMAP User Guide is available from http://edn.som.umaryland.edu/mmap/index.php.|||||>|0.05||||||Because no P-values less than 0.05 was observed, we did not adjust them for multiple comparison to avoid false positives.|Chi-squared|||Null hypothesis: There is no association between STK39 SNP rs35909607 genotype group and phenotypes collected in this study.||||>0.05
72563251|NCT00442546|144658163|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.489|STANDARD_ERROR_OF_MEAN|0.505||0.3361||95.0|-1.496|0.517|||ANOVA||Mean difference (final values) = Least squares mean difference|Month 3||0.517|-1.496|0.3361
72563252|NCT00442546|144658163|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.022|STANDARD_ERROR_OF_MEAN|0.469||0.9634||95.0|-0.955|0.912|||ANOVA||Mean difference (final values) = Least squares mean difference|Month 3||0.912|-0.955|0.9634
72620965|NCT00452400|144772846|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.446|STANDARD_ERROR_OF_MEAN|6.283||0.0973|TWO_SIDED|95.0|-1.911|22.803|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 2 mcg qd minus Placebo|||22.803|-1.911|0.0973
72563253|NCT00442546|144658163|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.446|STANDARD_ERROR_OF_MEAN|0.352||0.2098||95.0|-0.257|1.15|||ANOVA||Mean difference (final values) = Least squares mean difference|Month 6||1.150|-0.257|0.2098
72459708|NCT00896389|144442539|OTHER|Association between genotype and phenotype were tested using a linear mixed model, coding genotype as an independent variable with an additive genetic effect, and including age, age\^2, and sex as covariates in the model. All association analyses were run using the Mixed Models for Pedigree Analysis (MMAP) software program to account for the relatedness among study subjects. MMAP User Guide is available from http://edn.som.umaryland.edu/mmap/index.php.|||||>|0.05||||||Because no P-values less than 0.05 was observed, we did not adjust them for multiple comparison to avoid false positives.|Chi-squared|||Null hypothesis: There is no association between STK39 SNP rs35909607 genotype group and phenotypes collected in this study.||||>0.05
72563254|NCT00442546|144658163|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.265|STANDARD_ERROR_OF_MEAN|0.382||0.49||95.0|-0.497|1.027|||ANOVA||Mean difference (final values) = Least squares mean difference|Month 6||1.027|-0.497|0.4900
72563255|NCT00442546|144658164|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.006|STANDARD_ERROR_OF_MEAN|0.546||0.9912||95.0|-1.07|1.082|||ANOVA||Mean difference (final values) = Least squares mean difference|Discharge||1.082|-1.070|0.9912
72563256|NCT00442546|144658164|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.135|STANDARD_ERROR_OF_MEAN|0.554||0.8076||95.0|-1.227|0.957|||ANOVA||Mean difference (final values) = Least squares mean difference|Discharge||0.957|-1.227|0.8076
72563257|NCT00442546|144658164|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.179|STANDARD_ERROR_OF_MEAN|0.46||0.6978||95.0|-0.727|1.085|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2||1.085|-0.727|0.6978
72563258|NCT00442546|144658164|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.293|STANDARD_ERROR_OF_MEAN|0.47||0.5344||95.0|-1.219|0.634|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2||0.634|-1.219|0.5344
72563259|NCT00442546|144658164|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.062|STANDARD_ERROR_OF_MEAN|0.384||0.8721||95.0|-0.819|0.695|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4||0.695|-0.819|0.8721
72563260|NCT00442546|144658164|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.395|STANDARD_ERROR_OF_MEAN|0.394||0.3179||95.0|-1.173|0.383|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4||0.383|-1.173|0.3179
72563261|NCT00442546|144658164|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.094|STANDARD_ERROR_OF_MEAN|0.376||0.8037||95.0|-0.648|0.835|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET||0.835|-0.648|0.8037
72563262|NCT00442546|144658164|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.113|STANDARD_ERROR_OF_MEAN|0.39||0.7731||95.0|-0.656|0.881|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET||0.881|-0.656|0.7731
72563263|NCT00442546|144658164|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.468|STANDARD_ERROR_OF_MEAN|0.611||0.4461||95.0|-1.684|0.748|||ANOVA||Mean difference (final values) = Least squares mean difference|Month 3||0.748|-1.684|0.4461
72620966|NCT00452400|144772846|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|22.333|STANDARD_ERROR_OF_MEAN|6.36||0.0005|TWO_SIDED|95.0|9.824|34.842|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 5 mcg qd minus Placebo|||34.842|9.824|0.0005
72459709|NCT00896389|144442540|OTHER|Association between genotype and phenotype were tested using a linear mixed model, coding genotype as an independent variable with an additive genetic effect, and including age, age\^2, and sex as covariates in the model. All association analyses were run using the Mixed Models for Pedigree Analysis (MMAP) software program to account for the relatedness among study subjects. MMAP User Guide is available from http://edn.som.umaryland.edu/mmap/index.php.|||||>|0.05||||||Because no P-values less than 0.05 was observed, we did not adjust them for multiple comparison to avoid false positives.|Chi-squared|||Null hypothesis: There is no association between STK39 SNP rs35909607 genotype group and phenotypes collected in this study.||||>0.05
72459710|NCT00896389|144442541|OTHER|Association between genotype and phenotype were tested using a linear mixed model, coding genotype as an independent variable with an additive genetic effect, and including age, age\^2, and sex as covariates in the model. All association analyses were run using the Mixed Models for Pedigree Analysis (MMAP) software program to account for the relatedness among study subjects. MMAP User Guide is available from http://edn.som.umaryland.edu/mmap/index.php.|||||>|0.05||||||Because no P-values less than 0.05 was observed, we did not adjust them for multiple comparison to avoid false positives.|Chi-squared|||Null hypothesis: There is no association between STK39 SNP rs35929607 genotype group and phenotypes collected in this study.||||>0.05
72459711|NCT00896389|144442542|OTHER|Association between genotype and phenotype were tested using a linear mixed model, coding genotype as an independent variable with an additive genetic effect, and including age, age\^2, and sex as covariates in the model. All association analyses were run using the Mixed Models for Pedigree Analysis (MMAP) software program to account for the relatedness among study subjects. MMAP User Guide is available from http://edn.som.umaryland.edu/mmap/index.php.|||||>|0.05||||||Because no P-values less than 0.05 was observed, we did not adjust them for multiple comparison to avoid false positives.|Chi-squared|||Null hypothesis: There is no association between STK39 SNP rs35929607 genotype group and phenotypes collected in this study.||||>0.05
72459712|NCT00896389|144442543|OTHER|Association between genotype and phenotype were tested using a linear mixed model, coding genotype as an independent variable with an additive genetic effect, and including age, age\^2, and sex as covariates in the model. All association analyses were run using the Mixed Models for Pedigree Analysis (MMAP) software program to account for the relatedness among study subjects. MMAP User Guide is available from http://edn.som.umaryland.edu/mmap/index.php.|||||>|0.05||||||Because no P-values less than 0.05 was observed, we did not adjust them for multiple comparison to avoid false positives.|Chi-squared|||Null hypothesis: There is no association between STK39 SNP rs35929607 genotype group and phenotypes collected in this study.||||>0.05
72563264|NCT00442546|144658164|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.533|STANDARD_ERROR_OF_MEAN|0.575||0.3568||95.0|-1.679|0.612|||ANOVA||Mean difference (final values) = Least squares mean difference|Month 3||0.612|-1.679|0.3568
72459713|NCT00896389|144442544|OTHER|Association between genotype and phenotype were tested using a linear mixed model, coding genotype as an independent variable with an additive genetic effect, and including age, age\^2, and sex as covariates in the model. All association analyses were run using the Mixed Models for Pedigree Analysis (MMAP) software program to account for the relatedness among study subjects. MMAP User Guide is available from http://edn.som.umaryland.edu/mmap/index.php.|||||>|0.05||||||Because no P-values less than 0.05 was observed, we did not adjust them for multiple comparison to avoid false positives.|Chi-squared|||Null hypothesis: There is no association between STK39 SNP rs35929607 genotype group and phenotypes collected in this study.||||>0.05
72459714|NCT00896389|144442545|OTHER|Association between genotype and phenotype were tested using a linear mixed model, coding genotype as an independent variable with an additive genetic effect, and including age, age\^2, and sex as covariates in the model. All association analyses were run using the Mixed Models for Pedigree Analysis (MMAP) software program to account for the relatedness among study subjects. MMAP User Guide is available from http://edn.som.umaryland.edu/mmap/index.php.|||||>|0.05|||||||Chi-squared|Because no P-values less than 0.05 was observed, we did not adjust them for multiple comparison to avoid false positives.||Null hypothesis: There is no association between STK39 SNP rs35929607 genotype group and phenotypes collected in this study.||||>0.05
72459715|NCT03184519|144442553|SUPERIORITY||Area Under Curve|0.79||||0.025|ONE_SIDED||||||t-test, 1 sided|||||||0.025
72459716|NCT04239911|144442557|EQUIVALENCE|A p\<0.05 considered the threshold for statistical significance.|Odds Ratio (OR)|0.97||||0.974|TWO_SIDED|95.0|0.14|6.85|||Regression, Logistic||The comparison group is enhanced usual care arm|"Outcome measures workers' intentions of leaving their current job. Responses included 7-point likert scale of very strongly disagree-very strongly agree. Dichotomized into agree, strongly agree, and very strongly vs. other responses. We used logistic mixed regression model to compare outcome between and within study arm. Mixed effects included a variable for time point (baseline/90 days), indicator for study arm, a study arm by time point interaction and subject random intercept."||6.85|0.14|0.974
72459717|NCT04239911|144442557|EQUIVALENCE|A p\< 0.05 considered the threshold for statistical significance|Odds Ratio (OR)|0.8||||0.846|TWO_SIDED|95.0|0.08|7.72|||Regression, Logistic||The comparison group is enhanced usual care arm|"Outcome measures workers' intentions of searching for a new job. Responses included 7-point likert scale of very strongly disagree-very strongly agree. Dichotomized into agree, strongly agree, and very strongly vs. other responses. We used logistic mixed regression model to compare outcome between and within study arm. Mixed effects included a variable for time point (baseline/90 days), indicator for study arm, a study arm by time point interaction and subject random intercept."||7.72|0.08|0.846
72459718|NCT04239911|144442560|EQUIVALENCE|A p\<0.05 was considered the threshold for statistical significance.|Odds Ratio (OR)|0.18||||0.043|TWO_SIDED|95.0|0.03|0.94|||Regression, Logistic||The comparison group is enhanced usual care arm|"Preventable 911 calls if had been able to reach the doctor. Dichotomized into agree, strongly agree, and very strongly vs. all other responses. We used logistic mixed regression model to compare trajectory of all outcomes between and within study arms. Mixed effects included a fixed effects categorical variable for time point (baseline/90days), and indicator for study arm (enhanced usual care/intervention), a study arm by time point interaction and subject specific random intercept."||0.94|0.03|0.043
72563265|NCT00442546|144658164|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.598|STANDARD_ERROR_OF_MEAN|0.315||0.0623||95.0|-0.032|1.227|||ANOVA||Mean difference (final values) = Least squares mean difference|Month 6||1.227|-0.032|0.0623
72392523|NCT02155608|144292437|SUPERIORITY|||||||0.54||||||p \< .05 for statistical significance.|Mixed Models Analysis|Group: F = .38, df = 1/228.||Phase 1a: Outcomes were fitted via a mixed effects model with group-by-time interactions to test for treatment effects using a piecewise linear time trend. This was parameterized in the model as a standard linear variable, time (ranging from baseline to 4 weeks) and a second variable, time2, defined as 0 at baseline and time past week 1 for subsequent weeks. The time2 coefficient represents the change in slope after the initial week.||||.54
72459719|NCT04239911|144442560|EQUIVALENCE|A p\<0.05 considered the threshold for statistical significance.|Odds Ratio (OR)|1.01||||0.99|TWO_SIDED|95.0|0.22|4.58|||Regression, Logistic|||"Preventable 911 calls if had been able to reach the nurse/supervisor. Dichotomized into agree, strongly agree, and very strongly vs. other responses. We used logistic mixed regression model to compare trajectory of all outcomes between and within study arms. Mixed effects included a fixed effects categorical variable for time point (baseline/90days), and indicator for study arm (enhanced usual care/intervention), a study arm by time point interaction and subject specific random intercept."||4.58|0.22|0.99
72459720|NCT01580306|144442561|NON_INFERIORITY_OR_EQUIVALENCE|investigation of relative bioavailability (no formal testing)|Geometric Mean Ratio|113.57|STANDARD_DEVIATION|93.2|||TWO_SIDED|90.0|41.58|310.17|||ANOVA||the standard deviation is actually the geometric coefficient of variation|relative bioavailability comparison mild : normal||310.17|41.58|
72459721|NCT01580306|144442561|NON_INFERIORITY_OR_EQUIVALENCE|investigation of relative bioavailability (no formal testing)|Geometric Mean Ratio|178.31|STANDARD_DEVIATION|78.9|||TWO_SIDED|90.0|85.23|373.03|||ANOVA||the standard deviation is actually the geometric coefficient of variation|relative bioavailability comparison moderate : normal||373.03|85.23|
72459722|NCT01580306|144442561|NON_INFERIORITY_OR_EQUIVALENCE|investigation of relative bioavailability (no formal testing)|Geometric Mean Ratio|169.21|STANDARD_DEVIATION|97.7|||TWO_SIDED|90.0|73.19|391.17|||ANOVA||the standard deviation is actually the geometric coefficient of variation|relative bioavailability comparison severe : normal||391.17|73.19|
72459723|NCT01580306|144442562|NON_INFERIORITY_OR_EQUIVALENCE|investigation of relative bioavailability (no formal testing)|Geometric Mean Ratio|107.22|STANDARD_DEVIATION|107.7|||TWO_SIDED|90.0|35.16|327.01|||ANOVA||the standard deviation is actually the geometric coefficient of variation|relative bioavailability comparison mild : normal||327.01|35.16|
72459724|NCT01580306|144442562|NON_INFERIORITY_OR_EQUIVALENCE|investigation of relative bioavailability (no formal testing)|Geometric Mean Ratio|175.52|STANDARD_DEVIATION|70.4|||TWO_SIDED|90.0|89.55|344.06|||ANOVA||the standard deviation is actually the geometric coefficient of variation|relative bioavailability comparison moderate : normal||344.06|89.55|
72459725|NCT01580306|144442562|NON_INFERIORITY_OR_EQUIVALENCE|investigation of relative bioavailability (no formal testing)|Geometric Mean Ratio|120.98|STANDARD_DEVIATION|115.0|||TWO_SIDED|90.0|47.257|309.736|||ANOVA||the standard deviation is actually the geometric coefficient of variation|relative bioavailability comparison severe : normal||309.736|47.257|
72459726|NCT03345407|144442579|OTHER||Posterior adjusted median difference|-0.022|||||TWO_SIDED|95.0|-0.143|0.103|||||Treatment comparison (posterior adjusted median difference and 95% HPD CrI) of Nemiralisib 12.5 mcg and placebo for Day 84 change from Baseline FEV1 measured post-bronchodilator has been presented.|||0.103|-0.143|
72459727|NCT03345407|144442579|OTHER||Posterior adjusted median difference|-0.027|||||TWO_SIDED|95.0|-0.098|0.036|||||Treatment comparison (posterior adjusted median difference and 95% HPD CrI) of Nemiralisib 50 mcg and placebo for Day 84 change from Baseline FEV1 measured post-bronchodilator has been presented.|||0.036|-0.098|
72459728|NCT03345407|144442579|OTHER||Posterior adjusted median difference|-0.038|||||TWO_SIDED|95.0|-0.102|0.028|||||Treatment comparison (posterior adjusted median difference and 95% HPD CrI) of Nemiralisib 100 mcg and placebo for Day 84 change from Baseline FEV1 measured post-bronchodilator has been presented.|||0.028|-0.102|
72459729|NCT03345407|144442579|OTHER||Posterior adjusted median difference|0.005|||||TWO_SIDED|95.0|-0.064|0.071|||||Treatment comparison (posterior adjusted median difference and 95% HPD CrI) of Nemiralisib 250 mcg and placebo for Day 84 change from Baseline FEV1 measured post-bronchodilator has been presented.|||0.071|-0.064|
72459730|NCT03345407|144442579|OTHER||Posterior adjusted median difference|-0.003|||||TWO_SIDED|95.0|-0.075|0.061|||||Treatment comparison (posterior adjusted median difference and 95% HPD CrI) of Nemiralisib 500 mcg and placebo for Day 84 change from Baseline FEV1 measured post-bronchodilator has been presented.|||0.061|-0.075|
72459731|NCT03345407|144442579|OTHER||Posterior adjusted median difference|-0.004|||||TWO_SIDED|95.0|-0.051|0.042|||||Treatment comparison (posterior adjusted median difference and 95% HPD CrI) of Nemiralisib 750 mcg and placebo for Day 84 change from Baseline FEV1 measured post-bronchodilator has been presented.|||0.042|-0.051|
72459732|NCT03345407|144442580|OTHER||Posterior median exacerbation rate ratio|0.92|||||TWO_SIDED|95.0|0.6|1.4|||||Treatment comparison (posterior median exacerbation rate ratio and 95% HPD CrI) of Nemiralisib 50 mcg and placebo for moderate/severe exacerbations has been presented.|||1.40|0.60|
72459733|NCT03345407|144442580|OTHER||Posterior median exacerbation rate ratio|0.89|||||TWO_SIDED|95.0|0.57|1.35|||||Treatment comparison (posterior median exacerbation rate ratio and 95% HPD CrI) of Nemiralisib 100 mcg and placebo for moderate/severe exacerbations has been presented.|||1.35|0.57|
72459734|NCT03345407|144442580|OTHER||Posterior median exacerbation rate ratio|1.01|||||TWO_SIDED|95.0|0.65|1.5|||||Treatment comparison (posterior median exacerbation rate ratio and 95% HPD CrI) of Nemiralisib 250 mcg and placebo for moderate/severe exacerbations has been presented.|||1.50|0.65|
72459735|NCT03345407|144442580|OTHER||Posterior median exacerbation rate ratio|0.63|||||TWO_SIDED|95.0|0.37|1.02|||||Treatment comparison (posterior median exacerbation rate ratio and 95% HPD CrI) of Nemiralisib 500 mcg and placebo for moderate/severe exacerbations has been presented.|||1.02|0.37|
72459736|NCT03345407|144442580|OTHER||Posterior median exacerbation rate ratio|1.13|||||TWO_SIDED|95.0|0.85|1.52|||||Treatment comparison (posterior median exacerbation rate ratio and 95% HPD CrI) of Nemiralisib 750 mcg and placebo for moderate/severe exacerbations has been presented.|||1.52|0.85|
72459737|NCT03345407|144442581|OTHER||Posterior median hazard ratio|0.455|||||TWO_SIDED|95.0|0.054|1.103|||||Treatment comparison (Hazard Ratio and 95% HPD CrI) of Nemiralisib 12.5 mcg and placebo for time to next moderate/severe exacerbations has been presented.|||1.103|0.054|
72459738|NCT03345407|144442581|OTHER||Posterior median hazard ratio|0.991|||||TWO_SIDED|95.0|0.58|1.5|||||Treatment comparison (Hazard Ratio and 95% HPD CrI) of Nemiralisib 50 mcg and placebo for time to next moderate/severe exacerbations has been presented.|||1.500|0.580|
72459739|NCT03345407|144442581|OTHER||Posterior median hazard ratio|0.975|||||TWO_SIDED|95.0|0.581|1.467|||||Treatment comparison (Hazard Ratio and 95% HPD CrI) of Nemiralisib 100 mcg and placebo for time to next moderate/severe exacerbations has been presented.|||1.467|0.581|
72459740|NCT03345407|144442581|OTHER||Posterior median hazard ratio|1.132|||||TWO_SIDED|95.0|0.682|1.709|||||Treatment comparison (Hazard Ratio and 95% HPD CrI) of Nemiralisib 250 mcg and placebo for time to next moderate/severe exacerbations has been presented.|||1.709|0.682|
72459741|NCT03345407|144442581|OTHER||Posterior median hazard ratio|0.556|||||TWO_SIDED|95.0|0.268|0.902|||||Treatment comparison (Hazard Ratio and 95% HPD CrI) of Nemiralisib 500 mcg and placebo for time to next moderate/severe exacerbations has been presented.|||0.902|0.268|
72459742|NCT03345407|144442581|OTHER||Posterior median hazard ratio|1.149|||||TWO_SIDED|95.0|0.8|1.539|||||Treatment comparison (Hazard Ratio and 95% HPD CrI) of Nemiralisib 750 mcg and placebo for time to next moderate/severe exacerbations has been presented.|||1.539|0.800|
72459743|NCT03345407|144442584|OTHER||Posterior median odds ratio|1.01|||||TWO_SIDED|95.0|0.21|2.3|||||Treatment comparison between placebo and nemiralisib 12.5 mcg at Day 14 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||2.30|0.21|
72459744|NCT03345407|144442584|OTHER||Posterior median odds ratio|1.37|||||TWO_SIDED|95.0|0.76|2.17|||||Treatment comparison between placebo and nemiralisib 50 mcg at Day 14 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||2.17|0.76|
72459745|NCT03345407|144442584|OTHER||Posterior median odds ratio|0.99|||||TWO_SIDED|95.0|0.54|1.61|||||Treatment comparison between placebo and nemiralisib 100 mcg at Day 14 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||1.61|0.54|
72501069|NCT01381094|144532153|SUPERIORITY||||||=|0.0366|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 6).||||=0.0366
72459746|NCT03345407|144442584|OTHER||Posterior median odds ratio|0.94|||||TWO_SIDED|95.0|0.5|1.49|||||Treatment comparison between placebo and nemiralisib 250 mcg at Day 14 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||1.49|0.50|
72370523|NCT00488683|144251632|SUPERIORITY_OR_OTHER||R-square|0.06||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one month after booster vaccination for the serogroup W-135||||
72459747|NCT03345407|144442584|OTHER||Posterior median odds ratio|0.75|||||TWO_SIDED|95.0|0.38|1.25|||||Treatment comparison between placebo and nemiralisib 500 mcg at Day 14 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||1.25|0.38|
72501070|NCT01381094|144532153|SUPERIORITY||||||=|0.0004|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 6).||||=0.0004
72370524|NCT00488683|144251632|SUPERIORITY_OR_OTHER||R-square|0.0023||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one month after booster vaccination for the serogroup Y||||
72370525|NCT00488683|144251632|SUPERIORITY_OR_OTHER||R-square|0.08||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one month after booster vaccination for the serogroup Y||||
72370526|NCT00488683|144251633|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|-0.25||||0.59||95.0|||||Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccination and memory B cells rise from pre-booster to one month after booster vaccination for the serogroup A||||0.59
72370527|NCT00488683|144251633|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|-0.12||||0.68||95.0|||||Parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Pearson correlation coefficient between memory B cells one month after primary vaccination and memory B cells rise from pre-booster to one month after booster vaccination for the serogroup A||||0.68
72370528|NCT00488683|144251633|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|0.36||||0.12||95.0|||||Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccination and memory B cells rise from pre-booster to one month after booster vaccination for the serogroup C||||0.12
72370529|NCT00488683|144251633|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|0.22||||0.26||95.0|||||Parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Pearson correlation coefficient between memory B cells one month after primary vaccination and memory B cells rise from pre-booster to one month after booster vaccination for the serogroup C||||0.26
72370530|NCT00488683|144251633|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|0.43||||0.08||95.0|||||Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccination and memory B cells rise from pre-booster to one month after booster vaccination for the serogroup W-135||||0.08
72370531|NCT00488683|144251633|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|-0.17||||0.42||95.0|||||Parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Pearson correlation coefficient between memory B cells one month after primary vaccination and memory B cells rise from pre-booster to one month after booster vaccination for the serogroup W-135||||0.42
72370532|NCT00488683|144251633|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|0.77||||0.02||95.0|||||Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccination and memory B cells rise from pre-booster to one month after booster vaccination for the serogroup Y||||0.02
72370533|NCT00488683|144251633|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|-0.12||||0.65||95.0|||||Parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Pearson correlation coefficient between memory B cells one month after primary vaccination and memory B cells rise from pre-booster to one month after booster vaccination for the serogroup Y||||0.65
72501071|NCT01381094|144532153|SUPERIORITY||||||=|0.0012|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 6).||||=0.0012
72392524|NCT02155608|144292437|SUPERIORITY||||||<|0.0001||||||p \< .05 for statistical significance|Mixed Models Analysis|Time: F=39.97, df = 1/228||Phase 1a: Outcomes were fitted via a mixed effects model with group-by-time interactions to test for treatment effects using a piecewise linear time trend. This was parameterized in the model as a standard linear variable, time (ranging from baseline to 4 weeks) and a second variable, time2, defined as 0 at baseline and time past week 1 for subsequent weeks. The time2 coefficient represents the change in slope after the initial week.||||<.0001
72459748|NCT03345407|144442584|OTHER||Posterior median odds ratio|1.16|||||TWO_SIDED|95.0|0.77|1.63|||||Treatment comparison between placebo and nemiralisib 750 mcg at Day 14 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||1.63|0.77|
72459749|NCT03345407|144442584|OTHER||Posterior median odds ratio|1.21|||||TWO_SIDED|95.0|0.36|2.69|||||Treatment comparison between placebo and nemiralisib 12.5 mcg at Day 28 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||2.69|0.36|
72459750|NCT03345407|144442584|OTHER||Posterior median odds ratio|1.53|||||TWO_SIDED|95.0|0.82|2.33|||||Treatment comparison between placebo and nemiralisib 50 mcg at Day 28 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||2.33|0.82|
72459751|NCT03345407|144442584|OTHER||Posterior median odds ratio|1.16|||||TWO_SIDED|95.0|0.67|1.79|||||Treatment comparison between placebo and nemiralisib 100 mcg at Day 28 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||1.79|0.67|
72459752|NCT03345407|144442584|OTHER||Posterior median odds ratio|1.12|||||TWO_SIDED|95.0|0.63|1.74|||||Treatment comparison between placebo and nemiralisib 250 mcg at Day 28 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||1.74|0.63|
72459753|NCT03345407|144442584|OTHER||Posterior median odds ratio|0.55|||||TWO_SIDED|95.0|0.28|0.88|||||Treatment comparison between placebo and nemiralisib 500 mcg at Day 28 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||0.88|0.28|
72563266|NCT00442546|144658164|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.32|STANDARD_ERROR_OF_MEAN|0.343||0.3529||95.0|-0.364|1.005|||ANOVA||Mean difference (final values) = Least squares mean difference|Month 6||1.005|-0.364|0.3529
72459754|NCT03345407|144442584|OTHER||Posterior median odds ratio|1.08|||||TWO_SIDED|95.0|0.72|1.49|||||Treatment comparison between placebo and nemiralisib 750 mcg at Day 28 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||1.49|0.72|
72459755|NCT03345407|144442584|OTHER||Posterior median odds ratio|1.0|||||TWO_SIDED|95.0|0.3|2.17|||||Treatment comparison between placebo and nemiralisib 12.5 mcg at Day 56 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||2.17|0.30|
72459756|NCT03345407|144442584|OTHER||Posterior median odds ratio|1.46|||||TWO_SIDED|95.0|0.84|2.27|||||Treatment comparison between placebo and nemiralisib 50 mcg at Day 56 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||2.27|0.84|
72459757|NCT03345407|144442584|OTHER||Posterior median odds ratio|1.15|||||TWO_SIDED|95.0|0.65|1.78|||||Treatment comparison between placebo and nemiralisib 100 mcg at Day 56 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||1.78|0.65|
72459758|NCT03345407|144442584|OTHER||Posterior median odds ratio|1.09|||||TWO_SIDED|95.0|0.62|1.67|||||Treatment comparison between placebo and nemiralisib 250 mcg at Day 56 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||1.67|0.62|
72563267|NCT00442546|144658165|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.611|STANDARD_ERROR_OF_MEAN|0.417||0.1448||95.0|-1.434|0.212|||ANOVA||Mean difference (final values) = Least squares mean difference|Discharge||0.212|-1.434|0.1448
72563268|NCT00442546|144658165|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.665|STANDARD_ERROR_OF_MEAN|0.42||0.1148||95.0|-1.494|0.163|||ANOVA||Mean difference (final values) = Least squares mean difference|Discharge||0.163|-1.494|0.1148
72459759|NCT03345407|144442584|OTHER||Posterior median odds ratio|0.49|||||TWO_SIDED|95.0|0.26|0.77|||||Treatment comparison between placebo and nemiralisib 500 mcg at Day 56 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||0.77|0.26|
72459760|NCT03345407|144442584|OTHER||Posterior median odds ratio|1.04|||||TWO_SIDED|95.0|0.71|1.42|||||Treatment comparison between placebo and nemiralisib 750 mcg at Day 56 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||1.42|0.71|
72459761|NCT03345407|144442584|OTHER||Posterior median odds ratio|1.08|||||TWO_SIDED|95.0|0.32|2.38|||||Treatment comparison between placebo and nemiralisib 12.5 mcg at Day 84 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||2.38|0.32|
72459762|NCT03345407|144442584|OTHER||Posterior median odds ratio|1.29|||||TWO_SIDED|95.0|0.7|2.0|||||Treatment comparison between placebo and nemiralisib 50 mcg at Day 84 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||2.00|0.70|
72459763|NCT03345407|144442584|OTHER||Posterior median odds ratio|1.12|||||TWO_SIDED|95.0|0.63|1.71|||||Treatment comparison between placebo and nemiralisib 100 mcg at Day 84 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||1.71|0.63|
72459764|NCT03345407|144442584|OTHER||Posterior median odds ratio|0.95|||||TWO_SIDED|95.0|0.55|1.48|||||Treatment comparison between placebo and nemiralisib 250 mcg at Day 84 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||1.48|0.55|
72459765|NCT03345407|144442584|OTHER||Posterior median odds ratio|0.56|||||TWO_SIDED|95.0|0.31|0.87|||||Treatment comparison between placebo and nemiralisib 500 mcg at Day 84 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||0.87|0.31|
72459766|NCT03345407|144442584|OTHER||Posterior median odds ratio|1.08|||||TWO_SIDED|95.0|0.73|1.47|||||Treatment comparison between placebo and nemiralisib 750 mcg at Day 84 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||1.47|0.73|
72459767|NCT03345407|144442585|OTHER||Posterior median hazard ratio|1.053|||||TWO_SIDED|95.0|0.477|1.765|||||Treatment comparison between placebo and Nemiralisib 12.5 mcg was performed and posterior median hazard ratio and 95% HPD CrI has been presented.|||1.765|0.477|
72459768|NCT03345407|144442585|OTHER||Posterior median hazard ratio|1.2|||||TWO_SIDED|95.0|0.84|1.597|||||Treatment comparison between placebo and Nemiralisib 50 mcg was performed and posterior median hazard ratio and 95% HPD CrI has been presented.|||1.597|0.840|
72459769|NCT03345407|144442585|OTHER||Posterior median hazard ratio|1.06|||||TWO_SIDED|95.0|0.734|1.432|||||Treatment comparison between placebo and Nemiralisib 100 mcg was performed and posterior median hazard ratio and 95% HPD CrI has been presented.|||1.432|0.734|
72459770|NCT03345407|144442585|OTHER||Posterior median hazard ratio|1.03|||||TWO_SIDED|95.0|0.719|1.413|||||Treatment comparison between placebo and Nemiralisib 250 mcg was performed and posterior median hazard ratio and 95% HPD CrI has been presented.|||1.413|0.719|
72459771|NCT03345407|144442585|OTHER||Posterior median hazard ratio|0.751|||||TWO_SIDED|95.0|0.487|1.057|||||Treatment comparison between placebo and Nemiralisib 500 mcg was performed and posterior median hazard ratio and 95% HPD CrI has been presented.|||1.057|0.487|
72459772|NCT03345407|144442585|OTHER||Posterior median hazard ratio|1.149|||||TWO_SIDED|95.0|0.899|1.426|||||Treatment comparison between placebo and Nemiralisib 750 mcg was performed and posterior median hazard ratio and 95% HPD CrI has been presented.|||1.426|0.899|
72459773|NCT03345407|144442587|OTHER||Posterior median odds ratio|1.22|||||TWO_SIDED|95.0|0.35|2.7|||||Treatment comparison between placebo and nemiralisib 12.5 mcg at Day 28 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||2.70|0.35|
72459774|NCT03345407|144442587|OTHER||Posterior median odds ratio|1.11|||||TWO_SIDED|95.0|0.63|1.77|||||Treatment comparison between placebo and nemiralisib 50 mcg at Day 28 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||1.77|0.63|
72459775|NCT03345407|144442587|OTHER||Posterior median odds ratio|1.41|||||TWO_SIDED|95.0|0.77|2.17|||||Treatment comparison between placebo and nemiralisib 100 mcg at Day 28 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||2.17|0.77|
72459776|NCT03345407|144442587|OTHER||Posterior median odds ratio|1.28|||||TWO_SIDED|95.0|0.71|2.0|||||Treatment comparison between placebo and nemiralisib 250 mcg at Day 28 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||2.00|0.71|
72459777|NCT03345407|144442587|OTHER||Posterior median odds ratio|1.11|||||TWO_SIDED|95.0|0.61|1.75|||||Treatment comparison between placebo and nemiralisib 500 mcg at Day 28 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||1.75|0.61|
72563269|NCT00442546|144658165|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.448|STANDARD_ERROR_OF_MEAN|0.458||0.3285||95.0|-1.35|0.454|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2||0.454|-1.350|0.3285
72459778|NCT03345407|144442587|OTHER||Posterior median odds ratio|0.7|||||TWO_SIDED|95.0|0.46|0.99|||||Treatment comparison between placebo and nemiralisib 750 mcg at Day 28 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||0.99|0.46|
72459779|NCT03345407|144442587|OTHER||Posterior median odds ratio|0.64|||||TWO_SIDED|95.0|0.2|1.41|||||Treatment comparison between placebo and nemiralisib 12.5 mcg at Day 56 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||1.41|0.20|
72459780|NCT03345407|144442587|OTHER||Posterior median odds ratio|1.53|||||TWO_SIDED|95.0|0.84|2.46|||||Treatment comparison between placebo and nemiralisib 50 mcg at Day 56 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||2.46|0.84|
72459781|NCT03345407|144442587|OTHER||Posterior median odds ratio|0.95|||||TWO_SIDED|95.0|0.53|1.48|||||Treatment comparison between placebo and nemiralisib 100 mcg at Day 56 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||1.48|0.53|
72563270|NCT00442546|144658165|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.572|STANDARD_ERROR_OF_MEAN|0.466||0.2205||95.0|-1.49|0.346|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2||0.346|-1.490|0.2205
72563271|NCT00442546|144658165|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.19|STANDARD_ERROR_OF_MEAN|0.389||0.6266||95.0|-0.958|0.578|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4||0.578|-0.958|0.6266
72459782|NCT03345407|144442587|OTHER||Posterior median odds ratio|1.36|||||TWO_SIDED|95.0|0.74|2.16|||||Treatment comparison between placebo and nemiralisib 250 mcg at Day 56 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||2.16|0.74|
72459783|NCT03345407|144442587|OTHER||Posterior median odds ratio|0.76|||||TWO_SIDED|95.0|0.43|1.17|||||Treatment comparison between placebo and nemiralisib 500 mcg at Day 56 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||1.17|0.43|
72459784|NCT03345407|144442587|OTHER||Posterior median odds ratio|0.93|||||TWO_SIDED|95.0|0.63|1.27|||||Treatment comparison between placebo and nemiralisib 750 mcg at Day 56 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||1.27|0.63|
72459785|NCT03345407|144442587|OTHER||Posterior median odds ratio|0.54|||||TWO_SIDED|95.0|0.16|1.2|||||Treatment comparison between placebo and nemiralisib 12.5 mcg at Day 84 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||1.20|0.16|
72459786|NCT03345407|144442587|OTHER||Posterior median odds ratio|1.53|||||TWO_SIDED|95.0|0.79|2.56|||||Treatment comparison between placebo and nemiralisib 50 mcg at Day 84 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||2.56|0.79|
72459787|NCT03345407|144442587|OTHER||Posterior median odds ratio|0.83|||||TWO_SIDED|95.0|0.46|1.3|||||Treatment comparison between placebo and nemiralisib 100 mcg at Day 84 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||1.30|0.46|
72459788|NCT03345407|144442587|OTHER||Posterior median odds ratio|1.16|||||TWO_SIDED|95.0|0.62|1.86|||||Treatment comparison between placebo and nemiralisib 250 mcg at Day 84 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||1.86|0.62|
72459789|NCT03345407|144442587|OTHER||Posterior median odds ratio|0.65|||||TWO_SIDED|95.0|0.36|1.02|||||Treatment comparison between placebo and nemiralisib 500 mcg at Day 84 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||1.02|0.36|
72459790|NCT03345407|144442587|OTHER||Posterior median odds ratio|0.85|||||TWO_SIDED|95.0|0.57|1.17|||||Treatment comparison between placebo and nemiralisib 750 mcg at Day 84 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||1.17|0.57|
72459791|NCT03345407|144442588|OTHER||Posterior adjusted median difference|2.4|||||TWO_SIDED|95.0|-0.5|5.2|||||Treatment comparison between placebo and Nemiralisib 12.5 mcg at Day 28 was performed and posterior adjusted median difference and 95% HPD CrI has been presented.|||5.2|-0.5|
72459792|NCT03345407|144442588|OTHER||Posterior adjusted median difference|0.7|||||TWO_SIDED|95.0|-0.8|2.3|||||Treatment comparison between placebo and Nemiralisib 50 mcg at Day 28 was performed and posterior adjusted median difference and 95% HPD CrI has been presented.|||2.3|-0.8|
72459793|NCT03345407|144442588|OTHER||Posterior adjusted median difference|0.8|||||TWO_SIDED|95.0|-0.8|2.4|||||Treatment comparison between placebo and Nemiralisib 100 mcg at Day 28 was performed and posterior adjusted median difference and 95% HPD CrI has been presented.|||2.4|-0.8|
72563272|NCT00442546|144658165|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.502|STANDARD_ERROR_OF_MEAN|0.397||0.2077||95.0|-1.284|0.281|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4||0.281|-1.284|0.2077
72563273|NCT00442546|144658165|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.223|STANDARD_ERROR_OF_MEAN|0.385||0.5626||95.0|-0.982|0.536|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET||0.536|-0.982|0.5626
72563274|NCT00442546|144658165|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.368|STANDARD_ERROR_OF_MEAN|0.394||0.3507||95.0|-1.145|0.408|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET||0.408|-1.145|0.3507
72563275|NCT00442546|144658165|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.224|STANDARD_ERROR_OF_MEAN|0.64||0.7276||95.0|-1.498|1.05|||ANOVA||Mean difference (final values) = Least squares mean difference|Month 3||1.050|-1.498|0.7276
72563276|NCT00442546|144658165|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.558|STANDARD_ERROR_OF_MEAN|0.598||0.353||95.0|-1.748|0.631|||ANOVA||Mean difference (final values) = Least squares mean difference|Month 3||0.631|-1.748|0.3530
72563277|NCT00442546|144658165|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.186|STANDARD_ERROR_OF_MEAN|0.529||0.0283||95.0|0.13|2.242|||ANOVA||Mean difference (final values) = Least squares mean difference|Month 6||2.242|0.130|0.0283
72563278|NCT00442546|144658165|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.227|STANDARD_ERROR_OF_MEAN|0.573||0.6934||95.0|-0.918|1.372|||ANOVA||Mean difference (final values) = Least squares mean difference|Month 6||1.372|-0.918|0.6934
72563279|NCT00442546|144658166|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.553|STANDARD_ERROR_OF_MEAN|0.77||0.0476||95.0|-3.089|-0.017|||ANOVA||Mean difference (final values) = Least squares mean difference|12 hours||-0.017|-3.089|0.0476
72563280|NCT00442546|144658166|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.768|STANDARD_ERROR_OF_MEAN|0.764||0.0237||95.0|-3.293|-0.243|||ANOVA||Mean difference (final values) = Least squares mean difference|12 hours||-0.243|-3.293|0.0237
72563281|NCT00442546|144658166|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.276|STANDARD_ERROR_OF_MEAN|0.402||0.4925||95.0|-0.516|1.069|||ANOVA||Mean difference (final values) = Least squares mean difference|24 hours||1.069|-0.516|0.4925
72459794|NCT03345407|144442588|OTHER||Posterior adjusted median difference|-0.3|||||TWO_SIDED|95.0|-2.0|1.2|||||Treatment comparison between placebo and Nemiralisib 250 mcg at Day 28 was performed and posterior adjusted median difference and 95% HPD CrI has been presented.|||1.2|-2.0|
72563282|NCT00442546|144658166|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.089|STANDARD_ERROR_OF_MEAN|0.414||0.8299||95.0|-0.727|0.905|||ANOVA||Mean difference (final values) = Least squares mean difference|24 hours||0.905|-0.727|0.8299
72459795|NCT03345407|144442588|OTHER||Posterior adjacent median difference|1.6|||||TWO_SIDED|95.0|0.0|3.3|||||Treatment comparison between placebo and Nemiralisib 500 mcg at Day 28 was performed and posterior adjusted median difference and 95% HPD CrI has been presented.|||3.3|0.0|
72459796|NCT03345407|144442588|OTHER||Posterior adjusted median difference|0.0|||||TWO_SIDED|95.0|-1.1|1.1|||||Treatment comparison between placebo and Nemiralisib 750 mcg at Day 28 was performed and posterior adjusted median difference and 95% HPD CrI has been presented.|||1.1|-1.1|
72459797|NCT03345407|144442588|OTHER||Posterior adjusted median difference|2.3|||||TWO_SIDED|95.0|-0.5|5.4|||||Treatment comparison between placebo and Nemiralisib 12.5 mcg at Day 56 was performed and posterior adjusted median difference and 95% HPD CrI has been presented.|||5.4|-0.5|
72459798|NCT03345407|144442588|OTHER||Posterior adjusted median difference|0.8|||||TWO_SIDED|95.0|-0.9|2.4|||||Treatment comparison between placebo and Nemiralisib 50 mcg at Day 56 was performed and posterior adjusted median difference and 95% HPD CrI has been presented.|||2.4|-0.9|
72459799|NCT03345407|144442588|OTHER||Posterior adjusted median difference|-0.3|||||TWO_SIDED|95.0|-1.9|1.4|||||Treatment comparison between placebo and Nemiralisib 100 mcg at Day 56 was performed and posterior adjusted median difference and 95% HPD CrI has been presented.|||1.4|-1.9|
72459800|NCT03345407|144442588|OTHER||Posterior adjusted median difference|-0.5|||||TWO_SIDED|95.0|-2.3|1.0|||||Treatment comparison between placebo and Nemiralisib 250 mcg at Day 56 was performed and posterior adjusted median difference and 95% HPD CrI has been presented.|||1.0|-2.3|
72459801|NCT03345407|144442588|OTHER||Posterior adjusted median difference|0.4|||||TWO_SIDED|95.0|-1.2|2.2|||||Treatment comparison between placebo and Nemiralisib 500 mcg at Day 56 was performed and posterior adjusted median difference and 95% HPD CrI has been presented.|||2.2|-1.2|
72459802|NCT03345407|144442588|OTHER||Posterior adjusted median difference|-0.2|||||TWO_SIDED|95.0|-1.4|1.0|||||Treatment comparison between placebo and Nemiralisib 750 mcg at Day 56 was performed and posterior adjusted median difference and 95% HPD CrI has been presented.|||1.0|-1.4|
72459803|NCT03345407|144442588|OTHER||Posterior adjusted median difference|1.9|||||TWO_SIDED|95.0|-1.4|5.1|||||Treatment comparison between placebo and Nemiralisib 12.5 mcg at Day 84 was performed and posterior adjusted median difference and 95% HPD CrI has been presented.|||5.1|-1.4|
72459804|NCT03345407|144442588|OTHER||Posterior adjusted median difference|1.1|||||TWO_SIDED|95.0|-0.7|2.8|||||Treatment comparison between placebo and Nemiralisib 50 mcg at Day 84 was performed and posterior adjusted median difference and 95% HPD CrI has been presented.|||2.8|-0.7|
72459805|NCT03345407|144442588|OTHER||Posterior adjusted median difference|-0.5|||||TWO_SIDED|95.0|-2.3|1.1|||||Treatment comparison between placebo and Nemiralisib 100 mcg at Day 84 was performed and posterior adjsted median difference and 95% HPD CrI has been presented.|||1.1|-2.3|
72459806|NCT03345407|144442588|OTHER||Posterior adjusted median difference|-0.1|||||TWO_SIDED|95.0|-1.9|1.7|||||Treatment comparison between placebo and Nemiralisib 250 mcg at Day 84 was performed and posterior adjusted median difference and 95% HPD CrI has been presented.|||1.7|-1.9|
72459807|NCT03345407|144442588|OTHER||Posterior adjusted median difference|0.8|||||TWO_SIDED|95.0|-0.9|2.8|||||Treatment comparison between placebo and Nemiralisib 500 mcg at Day 84 was performed and posterior adjusted median difference and 95% HPD CrI has been presented.|||2.8|-0.9|
72459808|NCT03345407|144442588|OTHER||Posterior adjusted median difference|0.4|||||TWO_SIDED|95.0|-0.8|1.7|||||Treatment comparison between placebo and Nemiralisib 750 mcg at Day 84 was performed and posterior adjusted median difference and 95% HPD CrI has been presented.|||1.7|-0.8|
72459809|NCT03345407|144442589|OTHER||Posterior median odds ratio|0.51|||||TWO_SIDED|95.0|0.03|1.41|||||Treatment comparison between placebo and nemiralisib 12.5 mcg at Day 28 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||1.41|0.03|
72501072|NCT01381094|144532153|SUPERIORITY||||||<|0.0001|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 6).||||<0.0001
72501073|NCT01381094|144532153|SUPERIORITY||||||=|0.1779|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 6).||||=0.1779
72563283|NCT00442546|144658166|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.038|STANDARD_ERROR_OF_MEAN|0.37||0.9185||95.0|-0.766|0.691|||ANOVA||Mean difference (final values) = Least squares mean difference|48 hours||0.691|-0.766|0.9185
72459810|NCT03345407|144442589|OTHER||Posterior median odds ratio|0.87|||||TWO_SIDED|95.0|0.42|1.47|||||Treatment comparison between placebo and nemiralisib 50 mcg at Day 28 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||1.47|0.42|
72459811|NCT03345407|144442589|OTHER||Posterior median odds ratio|1.37|||||TWO_SIDED|95.0|0.69|2.24|||||Treatment comparison between placebo and nemiralisib 100 mcg at Day 28 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||2.24|0.69|
72459812|NCT03345407|144442589|OTHER||Posterior median odds ratio|1.78|||||TWO_SIDED|95.0|0.95|2.91|||||Treatment comparison between placebo and nemiralisib 250 mcg at Day 28 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||2.91|0.95|
72459813|NCT03345407|144442589|OTHER||Posterior median odds ratio|1.24|||||TWO_SIDED|95.0|0.61|2.08|||||Treatment comparison between placebo and nemiralisib 500 mcg at Day 28 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||2.08|0.61|
72459814|NCT03345407|144442589|OTHER||Posterior median odds ratio|0.95|||||TWO_SIDED|95.0|0.6|1.4|||||Treatment comparison between placebo and nemiralisib 750 mcg at Day 28 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||1.40|0.60|
72501074|NCT01381094|144532153|SUPERIORITY||||||=|0.5867|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).||||=0.5867
72459815|NCT03345407|144442589|OTHER||Posterior median odds ratio|0.54|||||TWO_SIDED|95.0|0.14|1.16|||||Treatment comparison between placebo and nemiralisib 12.5 mcg at Day 56 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||1.16|0.14|
72459816|NCT03345407|144442589|OTHER||Posterior median odds ratio|1.27|||||TWO_SIDED|95.0|0.74|1.98|||||Treatment comparison between placebo and nemiralisib 50 mcg at Day 56 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||1.98|0.74|
72459817|NCT03345407|144442589|OTHER||Posterior median odds ratio|1.29|||||TWO_SIDED|95.0|0.73|1.97|||||Treatment comparison between placebo and nemiralisib 100 mcg at Day 56 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||1.97|0.73|
72459818|NCT03345407|144442589|OTHER||Posterior median odds ratio|1.47|||||TWO_SIDED|95.0|0.83|2.27|||||Treatment comparison between placebo and nemiralisib 250 mcg at Day 56 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||2.27|0.83|
72501075|NCT01381094|144532153|SUPERIORITY||||||=|0.1306|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).||||=0.1306
72563284|NCT00442546|144658166|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.339|STANDARD_ERROR_OF_MEAN|0.371||0.3619||95.0|-1.07|0.392|||ANOVA||Mean difference (final values) = Least squares mean difference|48 hours||0.392|-1.070|0.3619
72563285|NCT00442546|144658166|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.358|STANDARD_ERROR_OF_MEAN|0.453||0.4309||95.0|-0.538|1.254|||ANOVA||Mean difference (final values) = Least squares mean difference|72 hours||1.254|-0.538|0.4309
72459819|NCT03345407|144442589|OTHER||Posterior median odds ratio|1.04|||||TWO_SIDED|95.0|0.57|1.62|||||Treatment comparison between placebo and nemiralisib 500 mcg at Day 56 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||1.62|0.57|
72459820|NCT03345407|144442589|OTHER||Posterior median odds ratio|1.1|||||TWO_SIDED|95.0|0.75|1.5|||||Treatment comparison between placebo and nemiralisib 750 mcg at Day 56 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||1.50|0.75|
72459821|NCT03345407|144442589|OTHER||Posterior median odds ratio|0.63|||||TWO_SIDED|95.0|0.17|1.39|||||Treatment comparison between placebo and nemiralisib 12.5 mcg at Day 84 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||1.39|0.17|
72459822|NCT03345407|144442589|OTHER||Posterior median odds ratio|1.27|||||TWO_SIDED|95.0|0.72|2.01|||||Treatment comparison between placebo and nemiralisib 50 mcg at Day 84 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||2.01|0.72|
72459823|NCT03345407|144442589|OTHER||Posterior median odds ratio|1.13|||||TWO_SIDED|95.0|0.64|1.79|||||Treatment comparison between placebo and nemiralisib 100 mcg at Day 84 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||1.79|0.64|
72459824|NCT03345407|144442589|OTHER||Posterior median odds ratio|1.35|||||TWO_SIDED|95.0|0.75|2.14|||||Treatment comparison between placebo and nemiralisib 250 mcg at Day 84 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||2.14|0.75|
72459825|NCT03345407|144442589|OTHER||Posterior median odds ratio|0.94|||||TWO_SIDED|95.0|0.53|1.45|||||Treatment comparison between placebo and nemiralisib 500 mcg at Day 84 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||1.45|0.53|
72459826|NCT03345407|144442589|OTHER||Posterior median odds ratio|1.03|||||TWO_SIDED|95.0|0.71|1.43|||||Treatment comparison between placebo and nemiralisib 750 mcg at Day 84 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||1.43|0.71|
72459827|NCT03345407|144442590|OTHER||Posterior adjusted median difference|2.0|||||TWO_SIDED|95.0|-4.8|8.3|||||Treatment comparison between placebo and Nemiralisib 12.5 mcg at Day 28 was performed and posterior adjusted median difference and 95% HPD CrI has been presented.|||8.3|-4.8|
72459828|NCT03345407|144442590|OTHER||Posterior adjusted median difference|-0.5|||||TWO_SIDED|95.0|-4.0|3.1|||||Treatment comparison between placebo and Nemiralisib 50 mcg at Day 28 was performed and posterior adjusted median difference and 95% HPD CrI has been presented.|||3.1|-4.0|
72459829|NCT03345407|144442590|OTHER||Posterior adjusted median difference|-2.9|||||TWO_SIDED|95.0|-6.2|1.1|||||Treatment comparison between placebo and Nemiralisib 100 mcg at Day 28 was performed and posterior adjusted median difference and 95% HPD CrI has been presented.|||1.1|-6.2|
72459830|NCT03345407|144442590|OTHER||Posterior adjusted median difference|-3.2|||||TWO_SIDED|95.0|-6.7|0.4|||||Treatment comparison between placebo and Nemiralisib 250 mcg at Day 28 was performed and posterior adjusted median difference and 95% HPD CrI has been presented.|||0.4|-6.7|
72459831|NCT03345407|144442590|OTHER||Posterior adjusted median difference|-0.1|||||TWO_SIDED|95.0|-4.0|3.5|||||Treatment comparison between placebo and Nemiralisib 500 mcg at Day 28 was performed and posterior adjusted median difference and 95% HPD CrI has been presented.|||3.5|-4.0|
72459832|NCT03345407|144442590|OTHER||Posterior adjusted median difference|-0.2|||||TWO_SIDED|95.0|-2.7|2.3|||||Treatment comparison between placebo and Nemiralisib 750 mcg at Day 28 was performed and posterior adjusted median difference and 95% HPD CrI has been presented.|||2.3|-2.7|
72459833|NCT03345407|144442590|OTHER||Posterior adjusted median difference|4.1|||||TWO_SIDED|95.0|-2.5|11.0|||||Treatment comparison between placebo and Nemiralisib 12.5 mcg at Day 56 was performed and posterior adjusted median difference and 95% HPD CrI has been presented.|||11.0|-2.5|
72459834|NCT03345407|144442590|OTHER||Posterior adjusted median difference|-1.2|||||TWO_SIDED|95.0|-4.8|2.5|||||Treatment comparison between placebo and Nemiralisib 50 mcg at Day 56 was performed and posterior adjusted median difference and 95% HPD CrI has been presented.|||2.5|-4.8|
72459835|NCT03345407|144442590|OTHER||Posterior adjusted median difference|-2.7|||||TWO_SIDED|95.0|-6.3|1.1|||||Treatment comparison between placebo and Nemiralisib 100 mcg at Day 56 was performed and posterior adjusted median difference and 95% HPD CrI has been presented.|||1.1|-6.3|
72459836|NCT03345407|144442590|OTHER||Posterior adjusted median difference|-3.3|||||TWO_SIDED|95.0|-7.3|0.4|||||Treatment comparison between placebo and Nemiralisib 250 mcg at Day 56 was performed and posterior adjusted median difference and 95% HPD CrI has been presented.|||0.4|-7.3|
72459837|NCT03345407|144442590|OTHER||Posterior adjusted median difference|-0.8|||||TWO_SIDED|95.0|-4.6|3.0|||||Treatment comparison between placebo and Nemiralisib 500 mcg at Day 56 was performed and posterior adjusted median difference and 95% HPD CrI has been presented.|||3.0|-4.6|
72459838|NCT03345407|144442590|OTHER||Posterior adjusted median difference|-0.4|||||TWO_SIDED|95.0|-2.9|2.5|||||Treatment comparison between placebo and Nemiralisib 750 mcg at Day 56 was performed and posterior adjusted median difference and 95% HPD CrI has been presented.|||2.5|-2.9|
72459839|NCT03345407|144442590|OTHER||Posterior adjusted median difference|2.4|||||TWO_SIDED|95.0|-4.8|9.4|||||Treatment comparison between placebo and Nemiralisib 12.5 mcg at Day 84 was performed and posterior adjusted median difference and 95% HPD CrI has been presented.|||9.4|-4.8|
72459840|NCT03345407|144442590|OTHER||Posterior adjusted median difference|-0.2|||||TWO_SIDED|95.0|-4.1|3.6|||||Treatment comparison between placebo and Nemiralisib 50 mcg at Day 84 was performed and posterior adjusted median difference and 95% HPD CrI has been presented.|||3.6|-4.1|
72563286|NCT00442546|144658166|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.013|STANDARD_ERROR_OF_MEAN|0.459||0.9778||95.0|-0.895|0.921|||ANOVA||Mean difference (final values) = Least squares mean difference|72 hours||0.921|-0.895|0.9778
72563287|NCT00442546|144658166|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.147|STANDARD_ERROR_OF_MEAN|0.777||0.8503||95.0|-1.411|1.706|||ANOVA||Mean difference (final values) = Least squares mean difference|96 hours||1.706|-1.411|0.8503
72459841|NCT03345407|144442590|OTHER||Posterior adjusted median difference|-2.3|||||TWO_SIDED|95.0|-6.1|1.8|||||Treatment comparison between placebo and Nemiralisib 100 mcg at Day 84 was performed and posterior adjusted median difference and 95% HPD CrI has been presented.|||1.8|-6.1|
72459842|NCT03345407|144442590|OTHER||Posterior adjusted median difference|-1.8|||||TWO_SIDED|95.0|-5.7|2.3|||||Treatment comparison between placebo and Nemiralisib 250 mcg at Day 84 was performed and posterior adjusted median difference and 95% HPD CrI has been presented.|||2.3|-5.7|
72459843|NCT03345407|144442590|OTHER||Posterior adjusted median difference|-0.3|||||TWO_SIDED|95.0|-4.5|3.8|||||Treatment comparison between placebo and Nemiralisib 500 mcg at Day 84 was performed and posterior adjusted median difference and 95% HPD CrI has been presented.|||3.8|-4.5|
72459844|NCT03345407|144442590|OTHER||Posterior adjusted median difference|1.2|||||TWO_SIDED|95.0|-1.7|4.0|||||Treatment comparison between placebo and Nemiralisib 750 mcg at Day 84 was performed and posterior adjusted median difference and 95% HPD CrI has been presented.|||4.0|-1.7|
72459845|NCT00065611|144442605|SUPERIORITY_OR_OTHER|||||||0.9074||95.0|||||Chi-squared|||||||0.9074
72459846|NCT00065611|144442606|SUPERIORITY_OR_OTHER|||||||0.4566||95.0|||||ANOVA|||||||0.4566
72459847|NCT00065611|144442607|SUPERIORITY_OR_OTHER|||||||0.3792||95.0|||||ANOVA|||||||0.3792
72459848|NCT00379210|144442627|SUPERIORITY_OR_OTHER||||||<|0.01||95.0|||||ANOVA|||Statistical tests are evaluated at an alpha level of 0.05 (corrected, when appropriate, for multiple comparisons). Analyses are performed on both response latency and accuracy on behavioral data. For latency analyses, mean response times for correct trials are calculated for each subject. Repeated-measures ANOVA are used for omnibus tests; paired t-tests are used for individual planned contrasts, with Bonferroni-corrected significance levels to maintain a .05 alpha level||||<0.01
72459849|NCT05072795|144442637|OTHER|||||||0.005|||||||t-test, 2 sided|||||||0.005
72459850|NCT04791917|144442697|SUPERIORITY|||||||0.26|||||||ANCOVA|F(1,41) = 1.32, partial eta squared = .03||2 (Sex: men vs. women) X 2 (Time: Pre- vs. post-exercise) x 2 (Group: DOMS vs. sham DOMS) mixed general linear model on breakpoint for alcohol including baseline urge to consume alcohol and AUDIT score as covariates. Here we report the results of the analysis of the Sex X Time X Group interaction.||||.26
72459851|NCT04791917|144442698|SUPERIORITY|||||||0.11|||||||ANCOVA|F(1,43) = 2.60, partial eta squared = .06||2 (Sex: men vs. women) X 2 (Time: Pre- vs. post-exercise) x 2 (Group: DOMS vs. sham DOMS) mixed general linear model on Omax for alcohol including baseline urge to consume alcohol and AUDIT score as covariates. Here we report the results of the analysis of the Sex X Time X Group interaction.||||.11
72459852|NCT04791917|144442699|SUPERIORITY|||||||0.17|||||||ANCOVA|F(1,42) = 1.95, partial eta squared = .04||2 (Sex: men vs. women) X 2 (Time: Pre- vs. post-exercise) x 2 (Group: DOMS vs. sham DOMS) mixed general linear model on alcohol Pmax including baseline urge to consume alcohol and AUDIT score as covariates. Here we report the results of the analysis of the Sex X Time X Group interaction.||||.17
72459853|NCT04791917|144442700|SUPERIORITY|||||||0.91|||||||ANCOVA|F(1,43)=.01, partial eta squared = .00||2 (Sex: men vs. women) X 2 (Time: Pre- vs. post-exercise) x 2 (Group: DOMS vs. sham DOMS) mixed general linear model on alcohol essential value including baseline urge to consume alcohol and AUDIT score as covariates. Here we report the results of the analysis of the Sex X Time X Group interaction.||||.91
72459854|NCT04791917|144442701|SUPERIORITY|||||||0.14|||||||ANCOVA|F(1,41) = 2.24, partial eta squared = .05||2 (Sex: men vs. women) X 2 (Time: Pre- vs. post-exercise) x 2 (Group: DOMS vs. sham DOMS) mixed general linear model on intensity of cannabis demand including baseline urge to consume cannabis and CUDIT score as covariates. Here we report the results of the analysis of the Sex X Time X Group interaction.||||.14
72459855|NCT04791917|144442702|SUPERIORITY|||||||0.83|||||||ANCOVA|F(1,41) = .04, partial eta squared = .001||2 (Sex: men vs. women) X 2 (Time: Pre- vs. post-exercise) x 2 (Group: DOMS vs. sham DOMS) mixed general linear model on breakpoint of cannabis demand including baseline urge to consume cannabis and CUDIT score as covariates. Here we report the results of the analysis of the Sex X Time X Group interaction.||||.83
72459856|NCT04791917|144442703|SUPERIORITY|||||||0.15|||||||ANCOVA|F(1,41) = 2.20, partial eta squared = .05||2 (Sex: men vs. women) X 2 (Time: Pre- vs. post-exercise) x 2 (Group: DOMS vs. sham DOMS) mixed general linear model on Omax for cannabis including baseline urge to consume cannabis and CUDIT score as covariates. Here we report the results of the analysis of the Sex X Time X Group interaction.||||.15
72459857|NCT04791917|144442704|SUPERIORITY|||||||0.24|||||||ANCOVA|F(1,41) = 1.41, partial eta squared = .03||2 (Sex: men vs. women) X 2 (Time: Pre- vs. post-exercise) x 2 (Group: DOMS vs. sham DOMS) mixed general linear model on Omax for cannabis including baseline urge to consume cannabis and CUDIT score as covariates. Here we report the results of the analysis of the Sex X Time X Group interaction.||||.24
72459858|NCT04791917|144442705|SUPERIORITY|||||||0.97|||||||ANCOVA|F(1,41) = .001, partial eta squared = .00||2 (Sex: men vs. women) X 2 (Time: Pre- vs. post-exercise) x 2 (Group: DOMS vs. sham DOMS) mixed general linear model on Essential Value for cannabis including baseline urge to consume cannabis and CUDIT score as covariates. Here we report the results of the analysis of the Sex X Time X Group interaction.||||.97
72459859|NCT04791917|144442705|SUPERIORITY|||||||0.03|||||||ANCOVA|F(1,41) = 4.86, partial eta squared = .11||2 (Sex: men vs. women) X 2 (Time: Pre- vs. post-exercise) x 2 (Group: DOMS vs. sham DOMS) mixed general linear model on Essential Value for cannabis including baseline urge to consume cannabis and CUDIT score as covariates. Here we report the results of the analysis of the Time X Group interaction.||||.03
72459860|NCT04791917|144442706|SUPERIORITY|||||||0.04|||||||ANCOVA|F(1,42) = 4.66, partial eta squared = .10||2 (Sex: men vs. women) X 2 (Time: Pre- vs. post-exercise) x 2 (Group: DOMS vs. sham DOMS) mixed general linear model on intensity of alcohol demand including baseline urge to consume alcohol and AUDIT score as covariates. Here we report the results of the analysis of the Sex X Time X Group interaction.||||.04
72459861|NCT04791917|144442706|SUPERIORITY||Slope|0.1||||0.26|TWO_SIDED||||||ANCOVA|||2 (Sex: men vs. women) X 2 (Time: Pre- vs. post-exercise) x 2 (Group: DOMS vs. sham DOMS) mixed general linear model on Intensity of alcohol demand including baseline urge to consume alcohol and AUDIT score as covariates. Here we report the results of the analysis of the effect of Time on Intensity for men in the DOMS group.||||.26
72459862|NCT04791917|144442706|SUPERIORITY||Slope|-0.09||||0.22|TWO_SIDED||||||ANCOVA|||2 (Sex: men vs. women) X 2 (Time: Pre- vs. post-exercise) x 2 (Group: DOMS vs. sham DOMS) mixed general linear model on Intensity of alcohol demand including baseline urge to consume alcohol and AUDIT score as covariates. Here we report the results of the analysis of the effect of Time on Intensity for women in the DOMS group.||||.22
72459863|NCT04791917|144442706|SUPERIORITY||Slope|-0.1||||0.27|TWO_SIDED||||||ANCOVA|||2 (Sex: men vs. women) X 2 (Time: Pre- vs. post-exercise) x 2 (Group: DOMS vs. sham DOMS) mixed general linear model on Intensity of alcohol demand including baseline urge to consume alcohol and AUDIT score as covariates. Here we report the results of the analysis of the effect of Time on Intensity for men in the sham DOMS group.||||.27
72459864|NCT04791917|144442706|SUPERIORITY||Slope|0.06||||0.49|TWO_SIDED||||||ANCOVA|||2 (Sex: men vs. women) X 2 (Time: Pre- vs. post-exercise) x 2 (Group: DOMS vs. sham DOMS) mixed general linear model on Intensity of alcohol demand including baseline urge to consume alcohol and AUDIT score as covariates. Here we report the results of the analysis of the effect of Time on Intensity for women in the sham DOMS group.||||.49
72563288|NCT00442546|144658166|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.845|STANDARD_ERROR_OF_MEAN|0.757||0.0183||95.0|-3.364|-0.326|||ANOVA||Mean difference (final values) = Least squares mean difference|96 hours||-0.326|-3.364|0.0183
72563289|NCT00442546|144658166|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.141|STANDARD_ERROR_OF_MEAN|0.956||0.286||95.0|-3.598|1.316|||ANOVA||Mean difference (final values) = Least squares mean difference|120 hours||1.316|-3.598|0.2860
72459865|NCT01989156|144442707|SUPERIORITY_OR_OTHER_LEGACY||Geometric LS Mean Ratio|12.58|||<|0.001|TWO_SIDED|95.0|9.27|17.05||The primary endpoints were tested using a multiple testing procedure to preserve the overall alpha level by simultaneously testing the endpoints using a closed procedure with each test performed at an alpha level of 2.5% one sided.|ANCOVA|ANCOVA model on MHBMA levels with product, sex, cigarette consumption, and baseline value as covariates.|Geometric LS Mean Ratio mTHS 2.2:mCC|"The hypothesis to be tested is that the geometric mean level on Day 5 of the biomarker of exposure for mTHS 2.2 is lower relative to mCC.~Analysis of the biomarkers of exposure (BoExp) was conducted on the natural log scale in order to test the following hypothesis (one sided test with 2.5% type I error probability):~* Null hypothesis (H0): m1≥m2~* Alternative hypothesis (H1): m1\<m2 Where m1 and m2 are the geometric means of the BoExp levels on Day 5 for mTHS 2.2 and mCC respectively."||17.05|9.27|<0.001
72459866|NCT01989156|144442708|SUPERIORITY_OR_OTHER_LEGACY||Geometric LS Mean Ratio|45.77|||<|0.001|TWO_SIDED|95.0|39.22|53.41||The primary endpoints were tested using a multiple testing procedure to preserve the overall alpha level by simultaneously testing the endpoints using a closed procedure with each test performed at an alpha level of 2.5% one sided.|ANCOVA|ANCOVA model on 3-HPMA levels with product, sex, cigarette consumption, and baseline value as covariates.|Geometric LS mean ratio mTHS 2.2:mCC|"The hypothesis to be tested is that the geometric mean level on Day 5 of the biomarker of exposure for mTHS 2.2 is lower relative to mCC.~Analysis of the BoExp was conducted on the natural log scale in order to test the following hypothesis (one sided test with 2.5% type I error probability):~* Null hypothesis (H0): m1≥m2~* Alternative hypothesis (H1): m1\<m2 Where m1 and m2 are the geometric means of the BoExp levels on Day 5 for mTHS 2.2 and mCC respectively."||53.41|39.22|<0.001
72459867|NCT01989156|144442709|SUPERIORITY_OR_OTHER_LEGACY||Geometric LS Mean Ratio|12.58|||<|0.001|TWO_SIDED|95.0|9.54|16.58||The primary endpoints were tested using a multiple testing procedure to preserve the overall alpha level by simultaneously testing the endpoints using a closed procedure with each test performed at an alpha level of 2.5% one sided.|ANCOVA|ANCOVA model on S-PMA levels with product, sex, cigarette consumption, and baseline value as covariates.|Geometric LS mean ratio mTHS 2.2:mCC|"The hypothesis to be tested is that the geometric mean level on Day 5 of the biomarker of exposure for mTHS 2.2 is lower relative to mCC.~Analysis of the BoExp was conducted on the natural log scale in order to test the following hypothesis (one sided test with 2.5% type I error probability):~* Null hypothesis (H0): m1≥m2~* Alternative hypothesis (H1): m1\<m2 Where m1 and m2 are the geometric means of the BoExp levels on Day 5 for mTHS 2.2 and mCC respectively."||16.58|9.54|<0.001
72563290|NCT00442546|144658166|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.71|STANDARD_ERROR_OF_MEAN|1.856||0.204||95.0|-7.479|2.06|||ANOVA||Mean difference (final values) = Least squares mean difference|120 hours||2.060|-7.479|0.2040
72459868|NCT01989156|144442710|SUPERIORITY_OR_OTHER_LEGACY||Geometric LS Mean Ratio|26.41|||<|0.001|TWO_SIDED|95.0|17.31|40.26||The primary endpoints were tested using a multiple testing procedure to preserve the overall alpha level by simultaneously testing the endpoints using a closed procedure with each test performed at an alpha level of 2.5% one sided.|ANCOVA|ANCOVA model on Total NNAL levels with product, sex, cigarette consumption, and baseline value as covariates|Geometric LS mean ratio mTHS 2.2:mCC|"The hypothesis to be tested is that the geometric mean level on Day 90 of the biomarker of exposure for mTHS 2.2 is lower relative to mCC.~Analysis of the BoExp was conducted on the natural log scale in order to test the following hypothesis (one sided test with 2.5% type I error probability):~* Null hypothesis (H0): m1≥m2~* Alternative hypothesis (H1): m1\<m2 Where m1 and m2 are the geometric means of the BoExp levels on Day 90 for mTHS 2.2 and mCC respectively."||40.26|17.31|<0.001
72459869|NCT01989156|144442711|SUPERIORITY_OR_OTHER_LEGACY||Geometric LS Mean Ratio|38.14|||<|0.001|TWO_SIDED|95.0|34.24|42.47||The primary endpoints were tested using a multiple testing procedure to preserve the overall alpha level by simultaneously testing the endpoints using a closed procedure with each test performed at an alpha level of 2.5% one sided.|ANCOVA|ANCOVA model on COHb levels with product, sex, cigarette consumption, and baseline value as covariates.|Geometric LS mean ratio mTHS 2.2:mCC|"The hypothesis to be tested is that the geometric mean level on Day 90 of the biomarker of exposure for mTHS 2.2 is lower relative to mCC.~Analysis of the BoExp was conducted on the natural log scale in order to test the following hypothesis (one sided test with 2.5% type I error probability):~* Null hypothesis (H0): m1≥m2~* Alternative hypothesis (H1): m1\<m2 Where m1 and m2 are the geometric means of the BoExp levels on Day 90 for mTHS 2.2 and mCC respectively."||42.47|34.24|<0.001
72459870|NCT02790788|144442712|SUPERIORITY||Mean Difference (Net)|3.3|STANDARD_ERROR_OF_MEAN|4.3||0.44|TWO_SIDED|95.0|-5.2|11.8|||t-test, 2 sided|||Independent Samples t-test||11.8|-5.2|0.44
72459871|NCT02790788|144442714|SUPERIORITY||Mean Difference (Net)|5.0|STANDARD_ERROR_OF_MEAN|3.6||0.17|TWO_SIDED|95.0|-2.2|12.2|||t-test, 2 sided|||||12.2|-2.2|0.17
72459872|NCT02790788|144442715|SUPERIORITY||Mean Difference (Final Values)|10.6|STANDARD_ERROR_OF_MEAN|5.0||0.043|TWO_SIDED|95.0|0.4|20.8|||t-test, 2 sided|||||20.8|0.4|0.043
72459873|NCT02790788|144442716|SUPERIORITY||Mean Difference (Net)|-2.0|STANDARD_ERROR_OF_MEAN|3.7||0.59|TWO_SIDED|95.0|-9.3|5.3|||t-test, 2 sided|||||5.3|-9.3|0.59
72459874|NCT02790788|144442717|SUPERIORITY||Mean Difference (Net)|1.0|STANDARD_ERROR_OF_MEAN|2.0||0.64|TWO_SIDED|95.0|-3.1|5.0|||t-test, 2 sided|||||5.0|-3.1|0.64
72459875|NCT02790788|144442718|SUPERIORITY||Mean Difference (Net)|-4.0|STANDARD_ERROR_OF_MEAN|3.0||0.2|TWO_SIDED|95.0|-10.1|2.1|||t-test, 2 sided|||||2.1|-10.1|0.20
72459876|NCT02790788|144442719|SUPERIORITY||Mean Difference (Net)|2.8|STANDARD_ERROR_OF_MEAN|1.9||0.14|TWO_SIDED|95.0|-0.9|6.6|||t-test, 2 sided|||||6.6|-0.9|0.14
72459877|NCT02790788|144442720|SUPERIORITY||Mean Difference (Net)|0.5|STANDARD_ERROR_OF_MEAN|3.4||0.9|TWO_SIDED|95.0|-6.4|7.3|||t-test, 2 sided|||||7.3|-6.4|0.90
72459878|NCT02790788|144442721|SUPERIORITY||Mean Difference (Net)|2.1|STANDARD_ERROR_OF_MEAN|2.2||0.33|TWO_SIDED|95.0|-2.2|6.4|||t-test, 2 sided|||||6.4|-2.2|0.33
72459879|NCT02790788|144442722|SUPERIORITY||Mean Difference (Net)|0.3|STANDARD_ERROR_OF_MEAN|2.8||0.92|TWO_SIDED|95.0|-5.3|5.8|||t-test, 2 sided|||REPORTED RESULTS CORRESPOND TO LVEDA WITHIN 12 HOURS AFTER ROSC||5.8|-5.3|0.92
72459880|NCT02790788|144442722|SUPERIORITY||Mean Difference (Net)|-0.81|STANDARD_ERROR_OF_MEAN|1.3||0.54|TWO_SIDED|95.0|-3.4|1.8|||t-test, 2 sided|||REPORTED RESULTS CORRESPOND TO RVEDA WITHIN 12 HOURS AFTER ROSC||1.8|-3.4|0.54
72459881|NCT02790788|144442722|SUPERIORITY||Mean Difference (Net)|4.6|STANDARD_ERROR_OF_MEAN|2.17||0.048|TWO_SIDED|95.0|0.04|9.15|||t-test, 2 sided|||REPORTED RESULTS CORRESPOND TO LVEDA AT 72 HOURS AFTER ROSC||9.15|0.04|0.048
72459882|NCT02790788|144442722|SUPERIORITY||Mean Difference (Net)|1.9|STANDARD_ERROR_OF_MEAN|1.4||0.18|TWO_SIDED|95.0|-1.0|4.7|||t-test, 2 sided|||REPORTED RESULTS CORRESPOND TO RVEDA AT 72 HOURS AFTER ROSC||4.7|-1.0|0.18
72459883|NCT02790788|144442723|SUPERIORITY||Mean Difference (Net)|-3.6|STANDARD_ERROR_OF_MEAN|3.6||0.32|TWO_SIDED|95.0|-10.9|3.7|||t-test, 2 sided|||REPORTED RESULTS CORRESPOND TO LVEF WITHIN 12 HOURS AFTER ROSC||3.7|-10.9|0.32
72459884|NCT02790788|144442723|SUPERIORITY||Mean Difference (Net)|-1.0|STANDARD_ERROR_OF_MEAN|3.1||0.76|TWO_SIDED|95.0|-7.2|5.3|||t-test, 2 sided|||REPORTED RESULTS CORRESPOND TO RVEF WITHIN 12 HOURS AFTER ROSC||5.3|-7.2|0.76
72459885|NCT02790788|144442723|SUPERIORITY||Mean Difference (Net)|-4.9|STANDARD_ERROR_OF_MEAN|4.2||0.25|TWO_SIDED|95.0|-13.5|3.7|||t-test, 2 sided|||REPORTED RESULTS CORRESPOND TO LVEF AT 72 HOURS AFTER ROSC||3.7|-13.5|0.25
72459886|NCT02790788|144442723|SUPERIORITY||Mean Difference (Net)|-1.8|STANDARD_ERROR_OF_MEAN|3.5||0.61|TWO_SIDED|95.0|-9.1|5.5|||t-test, 2 sided|||REPORTED RESULTS CORRESPOND TO RVEF WITHIN 72 HOURS AFTER ROSC||5.5|-9.1|0.61
72459887|NCT02790788|144442724|SUPERIORITY||Mean Difference (Net)|-0.07|STANDARD_ERROR_OF_MEAN|0.09||0.41|TWO_SIDED|95.0|-0.25|0.11|||t-test, 2 sided|||RESULTS CORRESPOND TO END-DIASTOLIC ECCI WITHIN 12 HOURS OF ROSC.||0.11|-0.25|0.41
72459888|NCT02790788|144442724|SUPERIORITY||Mean Difference (Net)|-0.08|STANDARD_ERROR_OF_MEAN|0.09||0.38|TWO_SIDED|95.0|-0.26|0.1|||t-test, 2 sided|||RESULTS CORRESPOND TO END-SYSTOLIC ECCI WITHIN 12 HOURS AFTER ROSC.||0.10|-0.26|0.38
72370534|NCT00488683|144251633|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|-0.25||||0.58||95.0|||||Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccination and memory B cells rise from pre-booster to one month after booster vaccination for the serogroup A||||0.58
72459889|NCT02790788|144442724|SUPERIORITY||Mean Difference (Net)|-0.08|STANDARD_ERROR_OF_MEAN|0.1||0.46|TWO_SIDED|95.0|-0.29|0.14|||t-test, 2 sided|||RESULTS CORRESPOND TO END-DIASTOLIC ECCI AT 72 HOURS AFTER ROSC.||0.14|-0.29|0.46
72459890|NCT02790788|144442724|SUPERIORITY||Mean Difference (Net)|-0.11|STANDARD_ERROR_OF_MEAN|0.11||0.34|TWO_SIDED|95.0|-0.33|0.12|||t-test, 2 sided|||RESULTS CORRESPOND TO END-SYSTOLIC ECCI AT 72 HOURS AFTER ROSC.||0.12|-0.33|0.34
72459891|NCT02790788|144442725|SUPERIORITY||Mean Difference (Net)|-0.1|STANDARD_ERROR_OF_MEAN|0.65||0.9|TWO_SIDED|95.0|-1.5|1.3|||t-test, 2 sided|||||1.3|-1.5|0.90
72459892|NCT02790788|144442726|SUPERIORITY||Mean Difference (Net)|0.2|STANDARD_ERROR_OF_MEAN|0.37||0.59|TWO_SIDED|95.0|-0.54|0.94|||t-test, 2 sided|||||0.94|-0.54|0.59
72459893|NCT02790788|144442727|SUPERIORITY||Mean Difference (Net)|0.17|STANDARD_ERROR_OF_MEAN|0.38||0.67|TWO_SIDED|95.0|-0.6|0.93|||t-test, 2 sided|||||0.93|-0.60|0.67
72459894|NCT02790788|144442728|SUPERIORITY||Mean Difference (Net)|0.19|STANDARD_ERROR_OF_MEAN|0.41||0.65|TWO_SIDED|95.0|-0.64|1.02|||t-test, 2 sided|||||1.02|-0.64|0.65
72459895|NCT02790788|144442729|SUPERIORITY||Mean Difference (Net)|0.8|STANDARD_ERROR_OF_MEAN|1.0||0.41|TWO_SIDED|95.0|-1.2|2.8||RESULTS CORRESPOND TO CORE BODY TEMPERATURE AVERAGED OVER 0-6 HOURS AFTER ROSC.|t-test, 2 sided|||||2.8|-1.2|0.41
72459896|NCT02790788|144442729|SUPERIORITY||Mean Difference (Net)|-0.36|STANDARD_ERROR_OF_MEAN|0.28||0.2|TWO_SIDED|95.0|-0.92|0.19|||t-test, 2 sided|||RESULTS CORRESPOND TO CORE BODY TEMPERATURE AVERAGED OVER 12-18 HOURS AFTER ROSC.||0.19|-0.92|0.20
72459897|NCT02790788|144442729|SUPERIORITY||Median Difference (Net)|-0.48|STANDARD_ERROR_OF_MEAN|0.26||0.07|TWO_SIDED|95.0|-1.0|0.04|||t-test, 2 sided|||RESULTS CORRESPOND TO CORE BODY TEMPERATURE AVERAGED OVER 12-18 HOURS AFTER ROSC.||0.04|-1.00|0.07
72459898|NCT02790788|144442729|SUPERIORITY||Mean Difference (Net)|-0.27|STANDARD_ERROR_OF_MEAN|0.29||0.36|TWO_SIDED|95.0|-0.85|0.31|||t-test, 2 sided|||RESULTS CORRESPOND TO CORE BODY TEMPERATURE AVERAGED OVER 18-24 HOURS AFTER ROSC.||0.31|-0.85|0.36
72459899|NCT02790788|144442729|SUPERIORITY||Median Difference (Net)|-0.16|STANDARD_ERROR_OF_MEAN|0.25||0.54|TWO_SIDED|95.0|-0.66|0.35|||t-test, 2 sided|||RESULTS CORRESPOND TO CORE BODY TEMPERATURE AVERAGED OVER 24-30 HOURS AFTER ROSC.||0.35|-0.66|0.54
72563291|NCT00442546|144658166|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.141|STANDARD_ERROR_OF_MEAN|0.295||0.6332||95.0|-0.722|0.44|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2||0.440|-0.722|0.6332
72563292|NCT00442546|144658166|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.196|STANDARD_ERROR_OF_MEAN|0.303||0.5183||95.0|-0.402|0.794|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2||0.794|-0.402|0.5183
72459900|NCT02790788|144442729|SUPERIORITY||Mean Difference (Net)|-0.14|STANDARD_ERROR_OF_MEAN|0.28||0.62|TWO_SIDED|95.0|-0.69|0.42|||t-test, 2 sided|||RESULTS CORRESPOND TO CORE BODY TEMPERATURE AVERAGED OVER 30-36 HOURS AFTER ROSC.||0.42|-0.69|0.62
72459901|NCT02790788|144442729|SUPERIORITY||Mean Difference (Net)|-0.15|STANDARD_ERROR_OF_MEAN|0.28||0.6|TWO_SIDED|95.0|-0.71|0.41|||t-test, 2 sided|||RESULTS CORRESPOND TO CORE BODY TEMPERATURE AVERAGED OVER 36-42 HOURS AFTER ROSC.||0.41|-0.71|0.60
72459902|NCT02790788|144442729|SUPERIORITY||Median Difference (Net)|-0.16|STANDARD_ERROR_OF_MEAN|0.26||0.54|TWO_SIDED|95.0|-0.69|0.36|||t-test, 2 sided|||RESULTS CORRESPOND TO CORE BODY TEMPERATURE AVERAGED OVER 42-48 HOURS AFTER ROSC.||0.36|-0.69|0.54
72459903|NCT02790788|144442730|SUPERIORITY||Mean Difference (Net)|0.71|STANDARD_ERROR_OF_MEAN|0.87||0.42|TWO_SIDED|95.0|-2.5|1.1|||t-test, 2 sided|||RESULTS CORRESPOND TO CBFI AT 4 HOURS AFTER ROSC AND AT A MEAN MAP LEVEL OF 75.5 MMHG||1.1|-2.5|0.42
72459904|NCT02790788|144442730|SUPERIORITY||Median Difference (Net)|0.68|STANDARD_ERROR_OF_MEAN|0.79||0.4|TWO_SIDED|95.0|-0.94|2.3|||t-test, 2 sided|||RESULTS CORRESPOND TO CBFI AT 4 HOURS AFTER ROSC AND AT A MEAN MAP LEVEL OF 96.0 MMHG||2.30|-0.94|0.40
72459905|NCT02790788|144442730|SUPERIORITY||Mean Difference (Net)|0.9|STANDARD_ERROR_OF_MEAN|1.15||0.44|TWO_SIDED|95.0|-1.49|3.28|||t-test, 2 sided|||RESULTS CORRESPOND TO CBFI AT 72 HOURS AFTER ROSC AND AT A MEAN MAP LEVEL OF 75.5 MMHG||3.28|-1.49|0.44
72459906|NCT02790788|144442730|SUPERIORITY||Median Difference (Net)|1.15|STANDARD_ERROR_OF_MEAN|1.23||0.36|TWO_SIDED|95.0|-1.4|3.7|||t-test, 2 sided|||RESULTS CORRESPOND TO CBFI AT 72 HOURS AFTER ROSC AND AT A MEAN MAP LEVEL OF 97.0 MMHG||3.70|-1.40|0.36
72459907|NCT02790788|144442731|SUPERIORITY|||||||0.84|||||||Mann Whitney|||||||0.84
72459908|NCT02790788|144442732|SUPERIORITY||Mean Difference (Net)|-0.025|STANDARD_ERROR_OF_MEAN|0.144||0.86|TWO_SIDED|95.0|-0.311|0.262|||t-test, 2 sided|||RESULTS CORRESPOND TO IL-6 AT 4 HOURS AFTER ROSC||0.262|-0.311|0.86
72459909|NCT02790788|144442732|SUPERIORITY||Mean Difference (Net)|-0.064|STANDARD_ERROR_OF_MEAN|0.111||0.56|TWO_SIDED|95.0|-0.287|0.158|||t-test, 2 sided|||RESULTS CORRESPOND TO TNF-α AT 4 HOURS AFTER ROSC||0.158|-0.287|0.56
72459910|NCT02790788|144442732|SUPERIORITY||Mean Difference (Net)|0.034|STANDARD_ERROR_OF_MEAN|0.053||0.52|TWO_SIDED|95.0|-0.071|0.139|||t-test, 2 sided|||RESULTS CORRESPOND TO IL-1β AT 4 HOURS AFTER ROSC||0.139|-0.071|0.52
72459911|NCT02790788|144442732|SUPERIORITY||Mean Difference (Net)|-0.041|STANDARD_ERROR_OF_MEAN|0.107||0.7|TWO_SIDED|95.0|-0.254|0.172|||t-test, 2 sided|||RESULTS CORRESPOND TO IL-8 AT 4 HOURS AFTER ROSC||0.172|-0.254|0.70
72459912|NCT02790788|144442732|SUPERIORITY||Mean Difference (Net)|0.007|STANDARD_ERROR_OF_MEAN|0.167||0.97|TWO_SIDED|95.0|-0.326|0.34|||t-test, 2 sided|||RESULTS CORRESPOND TO IL-10 AT 4 HOURS AFTER ROSC||0.340|-0.326|0.97
72459913|NCT02790788|144442732|SUPERIORITY||Median Difference (Net)|0.067|STANDARD_ERROR_OF_MEAN|0.129||0.61|TWO_SIDED|95.0|-0.192|0.326|||t-test, 2 sided|||RESULTS CORRESPOND TO IL-6 AT 24 HOURS AFTER ROSC||0.326|-0.192|0.61
72459914|NCT02790788|144442732|SUPERIORITY||Mean Difference (Net)|0.014|STANDARD_ERROR_OF_MEAN|0.126||0.91|TWO_SIDED|95.0|-0.238|0.267|||t-test, 2 sided|||RESULTS CORRESPOND TO TNFα AT 24 HOURS AFTER ROSC||0.267|-0.238|0.91
72459915|NCT02790788|144442732|SUPERIORITY||Mean Difference (Net)|-0.04|STANDARD_ERROR_OF_MEAN|0.03||0.19|TWO_SIDED|95.0|-0.1|0.021|||t-test, 2 sided|||RESULTS CORRESPOND TO IL-1β AT 24 HOURS AFTER ROSC||0.021|-0.100|0.19
72459916|NCT02790788|144442732|SUPERIORITY||Mean Difference (Net)|-0.022|STANDARD_ERROR_OF_MEAN|0.111||0.85|TWO_SIDED|95.0|-0.244|0.201|||t-test, 2 sided|||RESULTS CORRESPOND TO IL-8 AT 24 HOURS AFTER ROSC||0.201|-0.244|0.85
72459917|NCT02790788|144442732|SUPERIORITY||Mean Difference (Net)|0.147|STANDARD_ERROR_OF_MEAN|0.162||0.37|TWO_SIDED|95.0|-0.179|0.473|||t-test, 2 sided|||RESULTS CORRESPOND TO IL-10 AT 24 HOURS AFTER ROSC||0.473|-0.179|0.37
72459918|NCT02790788|144442732|SUPERIORITY||Mean Difference (Net)|-0.043|STANDARD_ERROR_OF_MEAN|0.127||0.74|TWO_SIDED|95.0|-0.298|0.212|||t-test, 2 sided|||RESULTS CORRESPOND TO IL-6 AT 48 HOURS AFTER ROSC||0.212|-0.298|0.74
72459919|NCT02790788|144442732|SUPERIORITY||Mean Difference (Net)|0.036|STANDARD_ERROR_OF_MEAN|0.14||0.8|TWO_SIDED|95.0|-0.246|0.318|||t-test, 2 sided|||RESULTS CORRESPOND TO ΤΝFα AT 48 HOURS AFTER ROSC||0.318|-0.246|0.80
72459920|NCT02790788|144442732|SUPERIORITY||Mean Difference (Net)|0.056|STANDARD_ERROR_OF_MEAN|0.043||0.2|TWO_SIDED|95.0|-0.03|0.142|||t-test, 2 sided|||RESULTS CORRESPOND TO IL-1β AT 48 HOURS AFTER ROSC||0.142|-0.030|0.20
72459921|NCT02790788|144442732|SUPERIORITY||Mean Difference (Net)|-0.024|STANDARD_ERROR_OF_MEAN|0.111||0.83|TWO_SIDED|95.0|-0.246|0.198|||t-test, 2 sided|||RESULTS CORRESPOND TO IL-8 AT 48 HOURS AFTER ROSC||0.198|-0.246|0.83
72459922|NCT02790788|144442732|SUPERIORITY||Mean Difference (Net)|0.027|STANDARD_ERROR_OF_MEAN|0.124||0.83|TWO_SIDED|95.0|-0.223|0.276|||t-test, 2 sided|||RESULTS CORRESPOND TO IL-10 AT 48 HOURS AFTER ROSC||0.276|-0.223|0.83
72459923|NCT02790788|144442732|SUPERIORITY||Mean Difference (Net)|0.03|STANDARD_ERROR_OF_MEAN|0.161||0.85|TWO_SIDED|95.0|-0.294|0.354|||t-test, 2 sided|||RESULTS CORRESPOND TO IL-6 AT 72 HOURS AFTER ROSC||0.354|-0.294|0.85
72459924|NCT02790788|144442732|SUPERIORITY||Mean Difference (Net)|0.048|STANDARD_ERROR_OF_MEAN|0.145||0.74|TWO_SIDED|95.0|-0.243|0.339|||t-test, 2 sided|||RESULTS CORRESPOND TO ΤΝFα AT 72 HOURS AFTER ROSC||0.339|-0.243|0.74
72501076|NCT01381094|144532153|SUPERIORITY||||||=|0.9889|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).||||=0.9889
72459925|NCT02790788|144442732|SUPERIORITY||Median Difference (Net)|0.013|STANDARD_ERROR_OF_MEAN|0.039||0.75|TWO_SIDED|95.0|-0.066|0.091|||t-test, 2 sided|||RESULTS CORRESPOND TO IL-1β AT 72 HOURS AFTER ROSC||0.091|-0.066|0.75
72459926|NCT02790788|144442732|SUPERIORITY||Mean Difference (Net)|-0.045|STANDARD_ERROR_OF_MEAN|0.096||0.64|TWO_SIDED|95.0|-0.238|0.149|||t-test, 2 sided|||RESULTS CORRESPOND TO IL-8 AT 72 HOURS AFTER ROSC||0.149|-0.238|0.64
72459927|NCT02790788|144442732|SUPERIORITY||Mean Difference (Net)|0.179|STANDARD_ERROR_OF_MEAN|0.147||0.23|TWO_SIDED|95.0|-0.116|0.475|||t-test, 2 sided|||RESULTS CORRESPOND TO IL-10 AT 72 HOURS AFTER ROSC||0.475|-0.116|0.23
72459928|NCT02790788|144442733|SUPERIORITY||Percent Difference|4.9||||0.45|TWO_SIDED|95.0|-4.8|14.6|||Fisher Exact|||||14.6|-4.8|0.45
72459929|NCT02790788|144442734|SUPERIORITY||Mann-Whitney U|50903.5||||0.68|TWO_SIDED||||||Mann Whitney|||RESULTS CORRESPOND TO THE NUMBER OF EPISODES OF HYPERGLYCEMIA||||0.68
72563293|NCT00442546|144658166|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.146|STANDARD_ERROR_OF_MEAN|0.306||0.6341||95.0|-0.75|0.458|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4||0.458|-0.750|0.6341
72459930|NCT02790788|144442734|SUPERIORITY||Mann Whitney U|52188.5||||0.68|TWO_SIDED||||||Mann-Whitney|||RESULTS CORRESPOND TO THE NUMBER OF EPISODES OF HYPERNATREMIA||||0.68
72459931|NCT02790788|144442734|SUPERIORITY||Mann-Whitney U|1128.5||||0.37|TWO_SIDED||||||Mann-Whitney|||RESULTS CORRESPOND TO THE NUMBER OF EPISODES OF INFECTION||||0.37
72459932|NCT00850993|144442735|OTHER|Pairwise comparison for each Stannsoporfin treatment group versus placebo.|LS Mean Difference|-13.45|||=|0.04|TWO_SIDED|95.0|-26.27|-0.62|||ANCOVA|||Last Observation Carry Forward (LOCF) is used to impute missing post-baseline TSB. Least-squares means are from an ANCOVA model for adjusted TSB with treatment and gestational age as fixed effects and baseline adjusted TSB as a covariate. TSB is calculated as \[(TSB - Phototherapy(PT) threshold)/ PT threshold \] X 100%.||-0.62|-26.27|=0.040
72459933|NCT00850993|144442735|OTHER||LS Mean Difference|-10.02|||=|0.117|TWO_SIDED|95.0|-22.61|2.58|||ANCOVA|||||2.58|-22.61|=0.117
72459934|NCT00850993|144442735|OTHER||LS Mean Difference|-14.93|||=|0.057|TWO_SIDED|95.0|-30.31|0.44|||ANCOVA|||||0.44|-30.31|=0.057
72459935|NCT00850993|144442736|OTHER|Pairwise comparison for Change from Baseline at 48 hours (Row 3) for Stannsoporfin treatment group versus placebo|LS Mean Difference|-1.81|||=|0.061|TWO_SIDED|95.0|-3.71|0.09|||ANCOVA|||Last Observation Carry Forward (LOCF) is used to impute missing post-baseline TSB. Analysis of covariance (ANCOVA) is conducted for TSB including treatment and gestational age as fixed effects and baseline TSB as a covariate. Least-squares means (LS means) and standard errors (SEM) are estimated for each treatment group and placebo. LS mean difference, 95% Confidence Interval, and p-value are estimated based on LS mean difference between each stannsoporfin group and placebo.||0.09|-3.71|=0.061
72459936|NCT00850993|144442736|OTHER|Pairwise comparison for Change from Baseline at 48 hours (Row 3) for Stannsoporfin treatment group versus placebo|LS Mean Difference|-1.34|||=|0.163|TWO_SIDED|95.0|-3.24|0.56|||ANCOVA|||Last Observation Carry Forward (LOCF) is used to impute missing post-baseline TSB. Analysis of covariance (ANCOVA) is conducted for TSB including treatment and gestational age as fixed effects and baseline TSB as a covariate. Least-squares means (LS means) and standard errors (SEM) are estimated for each treatment group and placebo. LS mean difference, 95% Confidence Interval, and p-value are estimated based on LS mean difference between each stannsoporfin group and placebo.||0.56|-3.24|=0.163
72459937|NCT00850993|144442736|OTHER|Pairwise comparison for Change from Baseline at 48 hours (Row 3) for Stannsoporfin treatment group versus placebo|LS Mean Difference|-2.63|||=|0.028|TWO_SIDED|95.0|-4.97|-0.3|||ANCOVA|||Last Observation Carry Forward (LOCF) is used to impute missing post-baseline TSB. Analysis of covariance (ANCOVA) is conducted for TSB including treatment and gestational age as fixed effects and baseline TSB as a covariate. Least-squares means (LS means) and standard errors (SEM) are estimated for each treatment group and placebo. LS mean difference, 95% Confidence Interval, and p-value are estimated based on LS mean difference between each stannsoporfin group and placebo.||-0.3|-4.97|=0.028
72459938|NCT01721109|144442787|EQUIVALENCE|A sample size of 14 participants was estimated to provide over 95% power to show pharmacokinetic equivalence between adult and adolescent participants. EVG population PK from historical adult data was used for comparison. The inter-subject standard deviation (natural log scale) of EVG AUCtau observed in the population PK data was 0.31 (historical data).|Geometric least squares mean ratio|1.3029|||||TWO_SIDED|90.0|1.0479|1.62||||||||1.6200|1.0479|
72459939|NCT02066389|144442825|SUPERIORITY|||||||0.153||||||Statistical tests were 1-sided at a significance level of 0.05.|Chi-squared|||||||0.153
72459940|NCT02066389|144442825|SUPERIORITY|||||||0.018||||||Statistical tests were 1-sided at a significance level of 0.05.|Chi-squared|||||||0.018
72459941|NCT02066389|144442825|SUPERIORITY|||||||0.001||||||Statistical tests were 1-sided at a significance level of 0.05.|Chi-squared|||||||0.001
72501077|NCT01381094|144532153|SUPERIORITY||||||=|0.2026|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).||||=0.2026
72501078|NCT01381094|144532153|SUPERIORITY||||||=|0.5703|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).||||=0.5703
72392525|NCT02155608|144292437|SUPERIORITY|||||||0.005||||||p \< .05 for statistical significance.|Mixed Models Analysis|Group \* time: F = 8.12, df = 1/228.||Phase 1a: Outcomes were fitted via a mixed effects model with group-by-time interactions to test for treatment effects using a piecewise linear time trend. This was parameterized in the model as a standard linear variable, time (ranging from baseline to 4 weeks) and a second variable, time2, defined as 0 at baseline and time past week 1 for subsequent weeks. The time2 coefficient represents the change in slope after the initial week.||||.005
72459942|NCT02066389|144442825|SUPERIORITY|||||||0.008||||||Statistical tests were 1-sided at a significance level of 0.05.|Chi-squared|||||||0.008
72459943|NCT02066389|144442825|SUPERIORITY|||||||0.001||||||Statistical tests were 1-sided at a significance level of 0.05.|Chi-squared|||||||0.001
72459944|NCT02066389|144442826|SUPERIORITY|||||||0.034||||||Statistical tests were 1-sided at a significance level of 0.05.|Chi-squared|||||||0.034
72459945|NCT02066389|144442826|SUPERIORITY|||||||0.003||||||Statistical tests were 1-sided at a significance level of 0.05.|Chi-squared|||||||0.003
72459946|NCT02066389|144442826|SUPERIORITY|||||||0.002||||||Statistical tests were 1-sided at a significance level of 0.05.|Chi-squared|||||||0.002
72459947|NCT02066389|144442826|SUPERIORITY|||||||0.01||||||Statistical tests were 1-sided at a significance level of 0.05.|Chi-squared|||||||0.010
72459948|NCT02066389|144442826|SUPERIORITY|||||||0.012||||||Statistical tests were 1-sided at a significance level of 0.05.|Chi-squared|||||||0.012
72459949|NCT02066389|144442827|SUPERIORITY|||||||0.023||||||Statistical tests were 1-sided at a significance level of 0.05.|Chi-squared|||||||0.023
72459950|NCT02066389|144442827|SUPERIORITY|||||||0.003||||||Statistical tests were 1-sided at a significance level of 0.05.|Chi-squared|||||||0.003
72459951|NCT02066389|144442827|SUPERIORITY|||||||0.145||||||Statistical tests were 1-sided at a significance level of 0.05.|Chi-squared|||||||0.145
72501079|NCT01381094|144532154|SUPERIORITY||||||<|0.0001|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 2).||||<0.0001
72459952|NCT02066389|144442827|SUPERIORITY|||||||0.007||||||Statistical tests were 1-sided at a significance level of 0.05.|Chi-squared|||||||0.007
72459953|NCT02066389|144442827|SUPERIORITY|||||||0.014||||||Statistical tests were 1-sided at a significance level of 0.05.|Chi-squared|||||||0.014
72459954|NCT02066389|144442828|SUPERIORITY|||||||0.005||||||Statistical tests were 1-sided at a significance level of 0.05.|Fisher Exact|||||||0.005
72459955|NCT02066389|144442828|SUPERIORITY||||||<|0.001||||||Statistical tests were 1-sided at a significance level of 0.05.|Fisher Exact|||||||<0.001
72459956|NCT02066389|144442828|SUPERIORITY|||||||0.01||||||Statistical tests were 1-sided at a significance level of 0.05.|Fisher Exact|||||||0.010
72459957|NCT02066389|144442828|SUPERIORITY|||||||0.002||||||Statistical tests were 1-sided at a significance level of 0.05.|Fisher Exact|||||||0.002
72459958|NCT02066389|144442828|SUPERIORITY|||||||0.024||||||Statistical tests were 1-sided at a significance level of 0.05.|Fisher Exact|||||||0.024
72459959|NCT02066389|144442829|SUPERIORITY|||||||0.015||||||Statistical tests were 1-sided at a significance level of 0.05.|Chi-squared|||||||0.015
72459960|NCT02066389|144442829|SUPERIORITY|||||||0.008||||||Statistical tests were 1-sided at a significance level of 0.05.|Chi-squared|||||||0.008
72459961|NCT02066389|144442829|SUPERIORITY|||||||0.029||||||Statistical tests were 1-sided at a significance level of 0.05.|Chi-squared|||||||0.029
72459962|NCT02066389|144442829|SUPERIORITY|||||||0.003||||||Statistical tests were 1-sided at a significance level of 0.05.|Chi-squared|||||||0.003
72459963|NCT02066389|144442829|SUPERIORITY|||||||0.343||||||Statistical tests were 1-sided at a significance level of 0.05.|Chi-squared|||||||0.343
72459964|NCT02066389|144442830|SUPERIORITY|||||||0.039||||||Statistical tests were 1-sided at a significance level of 0.05.|Chi-squared|||||||0.039
72459965|NCT02066389|144442830|SUPERIORITY|||||||0.039||||||Statistical tests were 1-sided at a significance level of 0.05.|Chi-squared|||||||0.039
72459966|NCT02066389|144442830|SUPERIORITY|||||||0.046||||||Statistical tests were 1-sided at a significance level of 0.05.|Chi-squared|||||||0.046
72459967|NCT02066389|144442830|SUPERIORITY|||||||0.005||||||Statistical tests were 1-sided at a significance level of 0.05.|Chi-squared|||||||0.005
72459968|NCT02066389|144442830|SUPERIORITY|||||||0.096||||||Statistical tests were 1-sided at a significance level of 0.05.|Chi-squared|||||||0.096
72459969|NCT02066389|144442831|SUPERIORITY|||||||0.269||||||Statistical tests were 1-sided at a significance level of 0.05.|Chi-squared|||||||0.269
72459970|NCT02066389|144442831|SUPERIORITY|||||||0.16||||||Statistical tests were 1-sided at a significance level of 0.05.|Chi-squared|||||||0.160
72459971|NCT02066389|144442831|SUPERIORITY|||||||1||||||Statistical tests were 1-sided at a significance level of 0.05.|Chi-squared|||||||1.000
72459972|NCT02066389|144442831|SUPERIORITY|||||||0.16||||||Statistical tests were 1-sided at a significance level of 0.05.|Chi-squared|||||||0.160
72459973|NCT02066389|144442831|SUPERIORITY|||||||1||||||Statistical tests were 1-sided at a significance level of 0.05.|Chi-squared|||||||1.000
72459974|NCT02907489|144442832|SUPERIORITY|||||||0.083||||||0.083 for 24 hours, Significant at P ≤ 0.05|Chi-squared|||||||0.083
72459975|NCT02907489|144442832|SUPERIORITY|||||||0.041||||||0.041 for 48 hours, Significant at P ≤ 0.05|Chi-squared|||||||0.041
72459976|NCT02907489|144442832|SUPERIORITY|||||||0.063||||||0.063 for 72 hours, Significant at P ≤ 0.05|Chi-squared|||||||0.063
72459977|NCT02907489|144442833|SUPERIORITY|||||||0.982||||||0.982 for S1, Significant at P ≤ 0.05|Chi-squared|||||||0.982
72459978|NCT02907489|144442833|SUPERIORITY|||||||0.467||||||0.467 for S2, Significant at P ≤ 0.05|Chi-squared|||||||0.467
72459979|NCT02907489|144442833|SUPERIORITY|||||||0.01||||||0.01 for S3 Significant at P ≤ 0.05|Chi-squared|||||||0.01
72459980|NCT00762853|144442834|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
72459981|NCT01755598|144442835|OTHER|Vaccine efficacy (VE) has been estimated from a Cox proportional hazard regression model (VE=1-hazard ratio) and 90% confidence intervals (CIs) and Wald p-value has been derived. The lower limit of the 90% two-sided CI for the VE against first occurrence of Definite pulmonary TB disease not associated with HIV-infection, meeting the case definition 1, is to be above 0%.|Vaccine efficacy rate|49.7||||0.043|TWO_SIDED|90.0|12.1|71.2|||Regression, Cox|||To evaluate the protective efficacy of two doses of the M72/AS01E candidate vaccine against Definite pulmonary TB disease not associated with HIV-infection, meeting the case definition 1, as compared to placebo.||71.2|12.1|0.0430
72459982|NCT01755598|144442836|OTHER|Vaccine efficacy (VE) has been estimated from a Cox proportional hazard regression model (VE=1-hazard ratio) and 90% confidence intervals (CIs) and Wald p-value has been derived. If the primary objective is met, this secondary objective is to be analysed using the following success criterion: The lower limit of the 90% two-sided CI for the VE against first occurrence of Definite pulmonary TB disease not associated with HIV infection, meeting the case definition 2, is to be above 0%.|Vaccine efficacy rate|61.67||||0.021|TWO_SIDED|90.0|24.084|80.647|||Regression, Cox|||To evaluate the protective efficacy of two doses of the M72/AS01E candidate vaccine against Definite Xpert MTB/Rif positive pulmonary TB disease not associated with HIV-infection, meeting the case definition 2, as compared to placebo.||80.647|24.084|0.0210
72459983|NCT02924051|144442855|EQUIVALENCE|With an alpha level of .05 and effective (post-attrition) sample size of approximately 25 participants per county, and 3 counties per treatment group, the power of the group comparison was at least 80%, assuming an ICC of .01 or less, and an observed difference in proportions of .25. The anticipated power for the longitudinal comparison of continuous outcomes was expected to be even greater under these assumptions given the greater power for the parametric tests.|Mean Difference (Final Values)|1.12||||0.26|TWO_SIDED|95.0|||||t-test, 2 sided|||||||0.26
72459984|NCT02924051|144442857|SUPERIORITY|||||||0.36|||||||t-test, 1 sided|||Comparison of Cooking Skills/Nutrition Education/MI at baseline and 12 months.||||0.36
72459985|NCT00828178|144442858|SUPERIORITY_OR_OTHER|||||||0.87|||||||t-test, 2 sided|||Statistical analysis system (SAS) software was used (SAS Institute Inc. Cary, North Carolina, SAS 9.2). Baseline demographic and clinical characteristics were summarized using appropriate descriptive statistics and compared across treatment groups using Chi-square. Two-sample t tests were used in the statistical analysis of the FMD outcomes. ANCOVA was used to compare the groups with respect to changes in clinical variables adjusting for baseline values.||||0.87
72563294|NCT00442546|144658166|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.236|STANDARD_ERROR_OF_MEAN|0.32||0.4607||95.0|-0.868|0.395|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4||0.395|-0.868|0.4607
72392526|NCT02155608|144292437|SUPERIORITY||||||<|0.0001||||||p \< .05 for statistical significance.|Mixed Models Analysis|Time2: F = 28.96, df = 1/228.||Phase 1a: Outcomes were fitted via a mixed effects model with group-by-time interactions to test for treatment effects using a piecewise linear time trend. This was parameterized in the model as a standard linear variable, time (ranging from baseline to 4 weeks) and a second variable, time2, defined as 0 at baseline and time past week 1 for subsequent weeks. The time2 coefficient represents the change in slope after the initial week.||||<.0001
72459986|NCT00828178|144442859|SUPERIORITY_OR_OTHER|||||||0.1801||||||This Statistical Analysis applies category SELENA-SLEDAI|t-test, 2 sided|||||||0.1801
72459987|NCT02009865|144442905|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-14.2||||0.017|TWO_SIDED|95.0|-26.2|-2.8|||Wilcoxon (Mann-Whitney)||The estimated median difference and its 95% CI were based on Hodges Lehmann procedure|Missing values were imputed using probabilities of missing estimated from logistic regression||-2.8|-26.2|0.017
72459988|NCT02009865|144442906|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-26.3||||0.0008|TWO_SIDED|95.0|-40.5|-11.5|||Wilcoxon (Mann-Whitney)||The estimated median difference and its 95% CI were based on Hodges Lehmann procedure.|Main analysis with missing values imputed using probabilities of missing estimated from logistic regression||-11.5|-40.5|0.0008
72459989|NCT02009865|144442907|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-9.0||||0.018|TWO_SIDED|95.0|-14.8|-2.8||Adjusted by using Hommel's procedure|Wilcoxon (Mann-Whitney)||The estimated median difference and its 95% CI were based on Hodges Lehmann procedure.|Missing values were imputed using probabilities of missing estimated from logistic regression||-2.8|-14.8|0.0180
72459990|NCT02009865|144442908|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-0.3||||0.7117|TWO_SIDED|95.0|-3.5|4.9||Adjusted by using Hommel's procedure|Wilcoxon (Mann-Whitney)||The estimated median difference and its 95% CI were based on Hodges Lehmann procedure.|Missing values were imputed using probabilities of missing estimated from logistic regression||4.9|-3.5|0.7117
72459991|NCT02009865|144442909|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-10.3||||0.3034|TWO_SIDED|95.0|-23.9|3.5||Adjusted by using Hommel's procedure|Wilcoxon (Mann-Whitney)||The estimated median difference and its 95% CI were based on Hodges Lehmann procedure.|Missing values were imputed using probabilities of missing estimated from logistic regression||3.5|-23.9|0.3034
72459992|NCT03677986|144442925|SUPERIORITY||Odds Ratio (OR)|0.92||||0.914|TWO_SIDED|95.0|0.21|4.14|||GEE|||||4.14|.21|0.914
72459993|NCT00424502|144442928|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.017|STANDARD_DEVIATION|1.34|<|0.0001|TWO_SIDED|95.0|1.39|2.64|||t-test, 2 sided|||Change from Baseline to Week 24||2.64|1.39|<0.0001
72459994|NCT00424502|144442929|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.276|STANDARD_DEVIATION|0.259|<|0.0001|TWO_SIDED|95.0|0.151|0.401|||t-test, 2 sided|||Change from baseline to Week 24||0.401|0.151|<0.0001
72459995|NCT00424502|144442932|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.4|STANDARD_DEVIATION|23.24||0.012|TWO_SIDED|95.0|3.52|25.28|||t-test, 2 sided|||Change from baseline to Week 24||25.28|3.52|0.012
72459996|NCT00424502|144442933|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.81|STANDARD_DEVIATION|8.21||0.337|TWO_SIDED|95.0|-2.03|5.65|||t-test, 2 sided|||Change from baseline to Week 24||5.65|-2.03|0.337
72563295|NCT00442546|144658166|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.104|STANDARD_ERROR_OF_MEAN|0.327||0.7499||95.0|-0.541|0.75|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET||0.750|-0.541|0.7499
72392527|NCT02155608|144292437|SUPERIORITY|||||||0.02||||||p \< .05 for statistical significance.|Mixed Models Analysis|Time: F = 6.23, df = 1/57.||Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5.||||.02
72459997|NCT05356130|144442953|SUPERIORITY|||||||0.014|||||||Mixed Models Analysis|||"We conducted the same two independent planned comparisons: Enhanced BLT Encouragement + Adherence Promotion compared to Minimal BLT Encouragement; Minimal BLT Encouragement and Enhanced BLT Encouragement + Adherence Promotion compared to TAU."||||0.014
72459998|NCT03141177|144442954|SUPERIORITY|Treatment A over Treatment C|Hazard Ratio (HR)|0.51|||<|0.0001|TWO_SIDED|95.0|0.41|0.64|||Stratified Log-Rank|||||0.64|0.41|<0.0001
72459999|NCT03141177|144442955|SUPERIORITY|Treatment A over Treatment C|Hazard Ratio (HR)|0.6||||0.001|TWO_SIDED|98.89|0.4|0.89|||Stratified Log-Rank|||||0.89|0.40|0.0010
72460000|NCT03141177|144442956|SUPERIORITY|Treatment A over Treatment C|Odds Ratio (OR)|3.52|||<|0.0001|TWO_SIDED|95.0|2.51|4.95|||Stratified Cochran-Mantel-Haenszel|||||4.95|2.51|<0.0001
72460001|NCT03141177|144442956|OTHER|Treatment A - Treatment C|Difference of Objective Response Rates|28.6|||||TWO_SIDED|95.0|21.7|35.6|||||Strata adjusted difference in objective response rate (Nivolumab+Cabozantinib - Sunitinib) based on DerSimonian and Laird.|||35.6|21.7|
72460002|NCT02680314|144442964|SUPERIORITY|||||||0.202|||||||Wilcoxon (Mann-Whitney)|||||||0.202
72460003|NCT00409006|144442977|SUPERIORITY_OR_OTHER|||||||0.0618||95.0|||||Log Rank|||||||0.0618
72460004|NCT00409006|144442978|SUPERIORITY_OR_OTHER|||||||0.369||95.0|||||Regression, Logistic|Used the Wald Chi-squared statistic from a logistic regression analysis.||||||0.369
72460005|NCT05361304|144443019|NON_INFERIORITY||Least square Mean (LSM) Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.012|||TWO_SIDED|95.0|-0.04|0.0|||Linear Mixed Model|Kenward and Roger method was used for denominator degrees of freedom.|LSM difference was calculated as Senofilcon A contact lenses made with a novel manufacturing technology minus Senofilcon A contact lenses made with the current manufacturing technology|It was calculated using a 2 independent sample means t-test with a 2-sided type I error rate of 5% with at least 80% statistical power, that 100 subjects were required to test for non-inferiority of the Senofilcon A contact lenses made with a novel manufacturing technology compared to the Senofilcon A contact lenses made with the current manufacturing technology for distance (4m) under HLLC.||0.000|-0.040|
72501080|NCT01381094|144532154|SUPERIORITY||||||=|0.0092|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 2).||||=0.0092
72501081|NCT01381094|144532154|SUPERIORITY||||||=|0.0012|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 2).||||=0.0012
72392528|NCT02155608|144292437|SUPERIORITY|||||||0.05||||||p \< .05 for statistical significance.|Mixed Models Analysis|Group: F = 4.18, df = 1/57.||Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5.||||.05
72460006|NCT05361304|144443019|NON_INFERIORITY||Least square Mean (LSM) Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.012|||TWO_SIDED|95.0|-0.03|0.02|||Linear Mixed Model|Kenward and Roger method was used for denominator degrees of freedom.|LSM difference was calculated as Senofilcon A contact lenses made with a novel manufacturing technology minus Senofilcon A contact lenses made with the current manufacturing technology|It was calculated using a 2 independent sample means t-test with a 2-sided type I error rate of 5% with at least 80% statistical power, that 100 subjects were required to test for non-inferiority of the Senofilcon A contact lenses made with a novel manufacturing technology compared to the Senofilcon A contact lenses made with the current manufacturing technology for distance (4m) under LLHC.||0.020|-0.030|
72460007|NCT05361304|144443020|NON_INFERIORITY||Least square Mean (LSM) Difference|0.27|STANDARD_ERROR_OF_MEAN|0.37|||TWO_SIDED|95.0|-0.46|1.01|||Linear Mixed Model|Kenward and Roger method was used for denominator degrees of freedom.|LSM difference was calculated as Senofilcon A contact lenses made with a novel manufacturing technology minus Senofilcon A contact lenses made with the current manufacturing technology|It was calculated using a 2 independent sample means t-test with a 2-sided type I error rate of 5% with at least 80% statistical power, that 100 subjects were required to test for non-inferiority of the Senofilcon A contact lenses made with a novel manufacturing technology compared to the Senofilcon A contact lenses made with the current manufacturing technology.||1.010|-0.460|
72460008|NCT05361304|144443021|NON_INFERIORITY||LSM Difference|4.0|STANDARD_ERROR_OF_MEAN|4.06|||TWO_SIDED|95.0|-4.1|12.0|||Linear Mixed Model|Kenward and Roger method was used for denominator degrees of freedom.|LSM difference was calculated as Senofilcon A contact lenses made with a novel manufacturing technology minus Senofilcon A contact lenses made with the current manufacturing technology|||12.0|-4.1|
72460009|NCT05361304|144443022|NON_INFERIORITY|Non-inferiority was declared if the lower bound of the confidence interval of the mean difference between Senofilcon A contact lenses made with a novel manufacturing technology and Senofilcon A contact lenses made with the current manufacturing technology is greater than -5.|LSM Differences|-0.3|STANDARD_ERROR_OF_MEAN|3.44|||TWO_SIDED|95.0|-7.1|6.5|||Linear Mixed Model|Kenward and Roger method was used for denominator degrees of freedom.|LSM difference was calculated as Senofilcon A contact lenses made with a novel manufacturing technology minus Senofilcon A contact lenses made with the current manufacturing technology|||6.5|-7.1|
72460010|NCT01877720|144443052|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Paired t-test|||||||<0.001
72460011|NCT01877720|144443053|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED||||||Paired t-test|||||||0.001
72460012|NCT01877720|144443054|SUPERIORITY_OR_OTHER|||||||0.74|TWO_SIDED||||||Paired t-test|||||||0.74
72563296|NCT00442546|144658166|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.075|STANDARD_ERROR_OF_MEAN|0.333||0.8231||95.0|-0.584|0.733|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET||0.733|-0.584|0.8231
72460013|NCT01877720|144443055|SUPERIORITY_OR_OTHER|||||||0.003|TWO_SIDED||||||Paired t-test|||||||0.003
72392529|NCT02155608|144292437|SUPERIORITY|||||||0.73||||||p \< .05 for statistical significance.|Mixed Models Analysis|Group \* time: F = .12, df = 1/57.||Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5.||||.73
72460014|NCT01877720|144443056|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED||||||Paired t-test|||||||0.002
72460015|NCT01877720|144443057|SUPERIORITY_OR_OTHER|||||||0.003|TWO_SIDED||||||Paired t-test|||||||0.003
72460016|NCT01877720|144443058|SUPERIORITY_OR_OTHER|||||||0.012|TWO_SIDED||||||Paired t-test|||||||0.012
72460017|NCT01877720|144443059|SUPERIORITY_OR_OTHER|||||||0.67|TWO_SIDED||||||Paired t-test|||||||0.67
72460018|NCT01877720|144443060|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Wilcoxon signed-rank test|||||||<0.001
72460019|NCT01877720|144443061|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Wilcoxon signed-rank test|||||||<0.001
72501082|NCT01381094|144532154|SUPERIORITY||||||<|0.0001|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 2).||||<0.0001
72501083|NCT01381094|144532154|SUPERIORITY||||||=|0.1157|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 2).||||=0.1157
72501084|NCT01381094|144532154|SUPERIORITY||||||=|0.0069|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 4).||||=0.0069
72501085|NCT01381094|144532154|SUPERIORITY||||||=|0.0034|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 4).||||=0.0034
72563297|NCT00442546|144658167|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.036|STANDARD_ERROR_OF_MEAN|0.709||0.1486||95.0|-2.452|0.379|||ANOVA||Mean difference (final values) = Least squares mean difference|12 hours||0.379|-2.452|0.1486
72563298|NCT00442546|144658167|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.903|STANDARD_ERROR_OF_MEAN|0.706||0.0089||95.0|-3.311|-0.494|||ANOVA||Mean difference (final values) = Least squares mean difference|12 hours||-0.494|-3.311|0.0089
72460020|NCT02068352|144443075|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference|11.93||||0.069|TWO_SIDED|95.0|-0.08|23.95||P-value was derived using Cochran-Mantel-Haenszel (CMH) test stratified by age group (\< 18 or ≥ 18) and region.|Cochran-Mantel-Haenszel|||||23.95|-0.08|0.0690
72460021|NCT02068352|144443075|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference|18.23||||0.0165|TWO_SIDED|95.0|4.99|31.46||P-value was derived using CMH test stratified by age group (\< 18 or ≥ 18) and region.|Cochran-Mantel-Haenszel|||||31.46|4.99|0.0165
72460022|NCT02068352|144443075|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference|12.3||||0.0617|TWO_SIDED|95.0|0.06|24.53||P-value was derived using CMH test stratified by age group (\< 18 or ≥ 18) and region.|Cochran-Mantel-Haenszel|||||24.53|0.06|0.0617
72501086|NCT01381094|144532154|SUPERIORITY||||||=|0.0067|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 4).||||=0.0067
72563299|NCT00442546|144658167|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.044|STANDARD_ERROR_OF_MEAN|0.344||0.8995||95.0|-0.635|0.722|||ANOVA||Mean difference (final values) = Least squares mean difference|24 hours||0.722|-0.635|0.8995
72563300|NCT00442546|144658167|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.303|STANDARD_ERROR_OF_MEAN|0.354||0.3918||95.0|-1.0|0.394|||ANOVA||Mean difference (final values) = Least squares mean difference|24 hours||0.394|-1.000|0.3918
72370535|NCT00488683|144251633|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|-0.19||||-0.51||95.0|||||Non-parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Spearman correlation coefficient between memory B cells one month after primary vaccination and memory B cells rise from pre-booster to one month after booster vaccination for the serogroup A||||-0.51
72370536|NCT00488683|144251633|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.28||||0.24||95.0|||||Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccination and memory B cells rise from pre-booster to one month after booster vaccination for the serogroup C||||0.24
72370537|NCT00488683|144251633|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.36||||0.06||95.0|||||Non-parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Spearman correlation coefficient between memory B cells one month after primary vaccination and memory B cells rise from pre-booster to one month after booster vaccination for the serogroup C||||0.06
72460023|NCT02068352|144443076|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.47||||0.0128|TWO_SIDED|95.0|-0.84|-0.1|||Mixed Models Analysis|MMRM with fixed effects of treatment, region, visit, age group, and interaction of treatment by visit as terms, Baseline score as a covariate.||||-0.10|-0.84|0.0128
72460024|NCT02068352|144443076|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.46||||0.0134|TWO_SIDED|95.0|-0.81|-0.1|||Mixed Models Analysis|MMRM with fixed effects of treatment, region, visit, age group, interaction of treatment by visit, Baseline score as a covariate.||||-0.10|-0.81|0.0134
72460025|NCT02068352|144443077|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.5||||0.0048|TWO_SIDED|95.0|-0.85|-0.16|||ANCOVA|Analysis of covariance (ANCOVA) model with treatment, region, age group as terms, and Baseline score as a covariate for change from Baseline.||||-0.16|-0.85|0.0048
72460026|NCT02068352|144443077|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.5||||0.0045|TWO_SIDED|95.0|-0.84|-0.16|||ANCOVA|ANCOVA model with treatment, region, age group as terms, and Baseline score as a covariate for change from Baseline.||||-0.16|-0.84|0.0045
72460027|NCT02068352|144443079|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|6.26||||0.4173|TWO_SIDED|95.0|-8.99|21.52||P-value was derived using CMH test stratified by age group (\< 18 or ≥ 18) and region.|Cochran-Mantel-Haenszel|||||21.52|-8.99|0.4173
72460028|NCT02068352|144443079|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.47||||0.4895|TWO_SIDED|95.0|-9.43|20.36||P-value was derived using CMH test stratified by age group (\< 18 or ≥ 18) and region.|Cochran-Mantel-Haenszel|||||20.36|-9.43|0.4895
72460029|NCT02068352|144443079|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|9.19||||0.2677|TWO_SIDED|95.0|-6.74|25.12||P-value was derived using CMH test stratified by age group (\< 18 or ≥ 18) and region.|Cochran-Mantel-Haenszel|||||25.12|-6.74|0.2677
72392530|NCT02155608|144292438|SUPERIORITY|||||||0.003||||||p \< .05 for statistical significance|Chi-squared|Group: F = 8.75, df = 1/168.||Phase 1a: Assessed effects of group and time on categorical measure CGI-I from Baseline through Visit 4.||||.003
72392531|NCT02155608|144292438|SUPERIORITY|||||||0.17||||||p \< .05 for statistical significance.|Chi-squared|Time: F = 1.69, df = 3/168.||Phase 1a: Assessed effects of group and time on categorical measure CGI-I from Baseline through Visit 4.||||.17
72392532|NCT02155608|144292438|SUPERIORITY|||||||0.46|||||||Chi-squared|Group: Chi-square = .53, df = 1.||Phase 1b: Assessed effects of group on categorical measure CGI-I from at Visit 5 compared to baseline.||||.46
72392533|NCT02155608|144292439|SUPERIORITY|||||||0.91|||||||Mixed Models Analysis|Group: F=.01; df =1/209.||Phase 1a: Outcomes were fitted via a mixed effects model with group-by-time interactions to test for treatment effects using a piecewise linear time trend. This was parameterized in the model as a standard linear variable, time (ranging from baseline to 4 weeks) and a second variable, time2, defined as 0 at baseline and time past week 1 for subsequent weeks. The time2 coefficient represents the change in slope after the initial week.||||.91
72460030|NCT02068352|144443079|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|10.12||||0.2319|TWO_SIDED|95.0|-5.63|25.87||P-value was derived using CMH test stratified by age group (\< 18 or ≥ 18) and region.|Cochran-Mantel-Haenszel|||||25.87|-5.63|0.2319
72460031|NCT02068352|144443080|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.11||||0.3213|TWO_SIDED|95.0|-3.33|1.11|||Mixed Models Analysis|MMRM with fixed effects of treatment, region, visit, age group, interaction of treatment by visit, Baseline score as a covariate.||||1.11|-3.33|0.3213
72460032|NCT02068352|144443080|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.09||||0.0594|TWO_SIDED|95.0|-4.27|0.08|||Mixed Models Analysis|MMRM with fixed effects of treatment, region, visit, age group, interaction of treatment by visit, Baseline score as a covariate.||||0.08|-4.27|0.0594
72460033|NCT02068352|144443080|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.03||||0.396|TWO_SIDED|95.0|-3.43|1.37|||Mixed Models Analysis|MMRM with fixed effects of treatment, region, visit, age group, interaction of treatment by visit, Baseline score as a covariate.||||1.37|-3.43|0.396
72460034|NCT02068352|144443080|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.9||||0.1135|TWO_SIDED|95.0|-4.26|0.46|||Mixed Models Analysis|MMRM with fixed effects of treatment, region, visit, age group, interaction of treatment by visit, Baseline score as a covariate.||||0.46|-4.26|0.1135
72460035|NCT02068352|144443081|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.49||||0.1703|TWO_SIDED|95.0|-3.63|0.65|||ANCOVA|ANCOVA model with treatment, region, age group as terms, and Baseline score as a covariate for change from Baseline.||||0.65|-3.63|0.1703
72460036|NCT02068352|144443081|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.56||||0.0176|TWO_SIDED|95.0|-4.67|-0.45|||ANCOVA|ANCOVA model with treatment, region, age group as terms, and Baseline score as a covariate for change from Baseline.||||-0.45|-4.67|0.0176
72392534|NCT02155608|144292439|SUPERIORITY|||||||0.0004|||||||Mixed Models Analysis|Time: F=13.03; df = 1/209.||Phase 1a: Outcomes were fitted via a mixed effects model with group-by-time interactions to test for treatment effects using a piecewise linear time trend. This was parameterized in the model as a standard linear variable, time (ranging from baseline to 4 weeks) and a second variable, time2, defined as 0 at baseline and time past week 1 for subsequent weeks. The time2 coefficient represents the change in slope after the initial week.||||.0004
72392535|NCT02155608|144292439|SUPERIORITY|||||||0.37|||||||Mixed Models Analysis|Group \* time: F = .83; df = 1/209.||Phase 1a: Outcomes were fitted via a mixed effects model with group-by-time interactions to test for treatment effects using a piecewise linear time trend. This was parameterized in the model as a standard linear variable, time (ranging from baseline to 4 weeks) and a second variable, time2, defined as 0 at baseline and time past week 1 for subsequent weeks. The time2 coefficient represents the change in slope after the initial week.||||.37
72392536|NCT02155608|144292439|SUPERIORITY|||||||0.007||||||Time2: F = 7.45, df = 1/209.|Mixed Models Analysis|||Phase 1a: Outcomes were fitted via a mixed effects model with group-by-time interactions to test for treatment effects using a piecewise linear time trend. This was parameterized in the model as a standard linear variable, time (ranging from baseline to 4 weeks) and a second variable, time2, defined as 0 at baseline and time past week 1 for subsequent weeks. The time2 coefficient represents the change in slope after the initial week.||||.007
72392537|NCT02155608|144292439|SUPERIORITY|||||||0.67||||||p \< .05 for statistical significance.|Mixed Models Analysis|Group: F = .19, df = 1/59.||Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5.||||.67
72460037|NCT02068352|144443081|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.41||||0.2381|TWO_SIDED|95.0|-3.78|0.95|||ANCOVA|ANCOVA model with treatment, region, age group as terms, and Baseline score as a covariate for change from Baseline.||||0.95|-3.78|0.2381
72460038|NCT02068352|144443081|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.36||||0.047|TWO_SIDED|95.0|-4.68|-0.03|||ANCOVA|ANCOVA model with treatment, region, age group as terms, and Baseline score as a covariate for change from Baseline.||||-0.03|-4.68|0.047
72460039|NCT02068352|144443082|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.4||||0.8196|TWO_SIDED|95.0|-13.5|10.7|||Mixed Models Analysis|MMRM with fixed effects of treatment, region, visit, age group, interaction of treatment by visit, Baseline score as a covariate.||||10.7|-13.5|0.8196
72460040|NCT02068352|144443082|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-11.83||||0.0503|TWO_SIDED|95.0|-23.69|0.02|||Mixed Models Analysis|MMRM with fixed effects of treatment, region, visit, age group, interaction of treatment by visit, Baseline score as a covariate.||||0.02|-23.69|0.0503
72460041|NCT02068352|144443082|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.68||||0.5902|TWO_SIDED|95.0|-17.22|9.85|||Mixed Models Analysis|MMRM with fixed effects of treatment, region, visit, age group, interaction of treatment by visit, Baseline score as a covariate.||||9.85|-17.22|0.5902
72460042|NCT02068352|144443082|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-13.42||||0.0482|TWO_SIDED|95.0|-26.73|-0.11|||Mixed Models Analysis|MMRM with fixed effects of treatment, region, visit, age group, interaction of treatment by visit, Baseline score as a covariate.||||-0.11|-26.73|0.0482
72460043|NCT02068352|144443083|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.0||||0.8633|TWO_SIDED|95.0|-12.48|10.48|||ANCOVA|ANCOVA model with treatment, region, age group as terms, and Baseline score as a covariate for change from Baseline.||||10.48|-12.48|0.8633
72460044|NCT02068352|144443083|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-11.54||||0.0452|TWO_SIDED|95.0|-22.83|-0.25|||ANCOVA|ANCOVA model with treatment, region, age group as terms, and Baseline score as a covariate for change from Baseline.||||-0.25|-22.83|0.0452
72460045|NCT02068352|144443083|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.73||||0.6746|TWO_SIDED|95.0|-15.58|10.12|||ANCOVA|ANCOVA model with treatment, region, age group as terms, and Baseline score as a covariate for change from Baseline.||||10.12|-15.58|0.6746
72460046|NCT02068352|144443083|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-13.05||||0.0432|TWO_SIDED|95.0|-25.69|-0.4|||ANCOVA|ANCOVA model with treatment, region, age group as terms, and Baseline score as a covariate for change from Baseline.||||-0.4|-25.69|0.0432
72460047|NCT00267956|144443114|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The study is designed to maintain a Type I error of 0.05 or less for the primary analysis|Cochran-Mantel-Haenszel (CMH) chi-square|Stratified by subject's prior anti-Tumor Necrosis Factor (TNF) exposure status (Yes/No).||Hypothesis: No difference between ustekinumab x 4 and placebo at a significant level of 0.05. Sample Size and power: With 70 partcipants in each treatment group, 5000 repetitions. Assuming a 20% ACR20 response in placebo participants regardless of prior anti-TNF exposure and a 35% ACR 20 and 45% ACR20 response in ustekinumab group for participants who had prior anti-TNF exposure, and who had no prior anti-TNF exposures, the power to detect the treatment difference is 0.85.||||<0.001
72460048|NCT00267956|144443115|SUPERIORITY_OR_OTHER|||||||0.004||95.0||||No multiplicity adjustment was made and nominal p-value was reported.|Cochran-Mantel-Haenszel (CMH) chi-square|Stratified by participant's prior anti-TNF exposure status (Yes/No).||Hypothesis: No difference between Group II and Group I at a significant level of 0.05.||||0.004
72460049|NCT00267956|144443116|SUPERIORITY_OR_OTHER|||||||0.005||95.0||||No multiplicity adjustment was made and nominal p-value was reported.|Cochran-Mantel-Haenszel (CMH) chi-square|Stratified by participant's prior anti-TNF exposure status (Yes/No).||Hypothesis: No difference between ustekinumab x 4 and placebo at a significant level of 0.05.||||0.005
72460050|NCT00267956|144443117|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||No multiplicity adjustment was made and nominal p-value was reported.|ANOVA on van der Waerden normal scores|Treatment and prior anti-TNF exposure (Yes/No) as factors in the model.||Hypothesis: No difference between ustekinumab x 4 and placebo at a significant level of 0.05.||||<0.001
72460051|NCT00267956|144443118|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||No multiplicity adjustment was made and nominal p-value was reported.|Cochran-Mantel-Haenszel (CMH) chi-square|Stratified by participant's prior anti-TNF exposure status (Yes/No).||Hypothesis: No difference between ustekinumab x 4 and placebo at a significant level of 0.05.||||<0.001
72460052|NCT00267956|144443119|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||No multiplicity adjustment was made and nominal p-value was reported.|ANOVA on van der Waerden normal scores|Treatment and prior anti-TNF exposure (Yes/No) as factors in the model.||Hypothesis: No difference between ustekinumab x 4 and placebo at asignificant level of 0.05.||||<0.001
72460053|NCT02246647|144443120|OTHER||Mean Difference (Final Values)|0.01||||0.87|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.87
72460054|NCT03557307|144443135|OTHER||percentage|62.9|||||TWO_SIDED|95.0|58.86|66.76|||Clopper-Pearson Exact CI|One sample Confidence Interval|Percentage of patients who achieved 100% reduction in daily OCS dose that are sustained over at least 4 weeks without worsening of asthma|||66.76|58.86|
72370538|NCT00488683|144251633|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.72||||0.001||95.0|||||Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccination and memory B cells rise from pre-booster to one month after booster vaccination for the serogroup W-135||||0.001
72460055|NCT03557307|144443136|OTHER||percentage|81.9|||||TWO_SIDED|95.0|78.62|84.94|||Clopper-Pearson Exact CI|One sample Confidence Interval|Percentage of patients who achieve 100% reduction or a daily OCS dose of \<=5mg, if reason for no further OCS reduction is Adrenal Insufficiency, that are sustained over at least 4 weeks without worsening of asthma|||84.94|78.62|
72460056|NCT03557307|144443137|OTHER||percentage|91.5|||||TWO_SIDED|95.0|88.94|93.58|||Clopper-Pearson Exact CI|One sample Confidence Interval|Percentage of patients who achieve a daily OCS dose of ≤5 mg (regardless of reason for no further OCS reduction), that are sustained over at least 4 weeks without worsening of asthma|||93.58|88.94|
72460057|NCT03557307|144443138|OTHER||percentage|64.0|||||TWO_SIDED|95.0|60.06|67.9|||Clopper-Pearson Exact CI|One sample Confidence Interval (≥90% reduction)|Percentage of patients who achieve \>=90% reduction in daily OCS dose that are sustained over at least 4 weeks without worsening of asthma|||67.90|60.06|
72460058|NCT03557307|144443138|OTHER||percentage|68.9|||||TWO_SIDED|95.0|65.02|72.59|||Clopper-Pearson Exact CI|One sample Confidence Interval (\>=75% reduction)|Percentage of patients who achieve \>=75% reduction in daily OCS dose that are sustained over at least 4 weeks without worsening of asthma|||72.59|65.02|
72460059|NCT03557307|144443138|OTHER||percentage|81.8|||||TWO_SIDED|95.0|78.44|84.79|||Clopper-Pearson Exact CI|One sample Confidence Interval (\>=50% reduction)|Percentage of patients who achieve \>=50% reduction in daily OCS dose that are sustained over at least 4 weeks without worsening of asthma|||84.79|78.44|
72460060|NCT03557307|144443139|OTHER||percentage change from baseline|-76.92|||||TWO_SIDED|95.0|-79.9|-73.94|||Clopper-Pearson Exact CI|One sample Confidence Interval|Percentage change from baseline in daily OCS dose at the end of OCS reduction phase|||-73.94|-79.90|
72370539|NCT00488683|144251633|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|-0.32||||0.12||95.0|||||Non-parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Spearman correlation coefficient between memory B cells one month after primary vaccination and memory B cells rise from pre-booster to one month after booster vaccination for the serogroup W-135||||0.12
72370540|NCT00488683|144251633|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.49||||0.18||95.0|||||Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccination and memory B cells rise from pre-booster to one month after booster vaccination for the serogroup Y||||0.18
72370541|NCT00488683|144251633|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|-0.25||||0.34||95.0|||||Non-parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Spearman correlation coefficient between memory B cells one month after primary vaccination and memory B cells rise from pre-booster to one month after booster vaccination for the serogroup Y||||0.34
72460061|NCT02069366|144443144|SUPERIORITY||||||>|0.05||||||RM-ANOVA. Significance threshold p\<0.05, FWE-corrected.|ANOVA|RM-ANOVA with group and stimulus factors.||This analysis corresponds to the row 'Extinction Learning CS+E Amygdala- Visit 3' in the Brain Measures outcome table. RM-ANOVA including stimulus (CS+E, CS-, CS+U).||||>0.05
72460062|NCT02069366|144443144|SUPERIORITY|||||||0.041||||||Repeated-measures ANOVA (SPM12, ROI small-volume corrected). Significance threshold p\<0.05, FWE-corrected.|ANOVA|RM-ANOVA with group and stimulus factors.||This analysis corresponds to the row 'Extinction Learning CS+E Hippocampus- Visit 3' in the Brain Measures outcome table. RM-ANOVA including stimulus (CS+E, CS-, CS+U).||||0.041
72460063|NCT02069366|144443144|SUPERIORITY|||||||0.04||||||Repeated-measures ANOVA (SPM12, ROI small-volume corrected). Significance threshold p\<0.05, FWE-corrected.|ANOVA|RM-ANOVA with group and stimulus factors.||This analysis corresponds to the row 'Extinction Learning CS+E vmPFC- Visit 3' in the Brain Measures outcome table. RM-ANOVA including stimulus (CS+E, CS-, CS+U)||||0.040
72460064|NCT02069366|144443144|SUPERIORITY||||||>|0.05||||||RM-ANOVA. Significance threshold p\<0.05, FWE-corrected.|ANOVA|RM-ANOVA with group and stimulus factors.||This analysis corresponds to the row 'Extinction Learning CS- Amygdala- Visit 3' in the Brain Measures outcome table. RM-ANOVA including stimulus (CS+E, CS-, CS+U).||||>0.05
72460065|NCT02069366|144443144|SUPERIORITY|||||||0.041||||||Repeated-measures ANOVA (SPM12, ROI small-volume corrected). Significance threshold p\<0.05, FWE-corrected.|ANOVA|RM-ANOVA with group and stimulus factors.||This analysis corresponds to the row 'Extinction Learning CS- Hippocampus- Visit 3' in the Brain Measures outcome table. RM-ANOVA including stimulus (CS+E, CS-, CS+U).||||0.041
72460066|NCT02069366|144443144|SUPERIORITY|||||||0.04||||||Repeated-measures ANOVA (SPM12, ROI small-volume corrected). Significance threshold p\<0.05, FWE-corrected.|ANOVA|RM-ANOVA with group and stimulus time factors.||This analysis corresponds to the row 'Extinction Learning CS- vmPFC- Visit 3' in the Brain Measures outcome table. RM-ANOVA including stimulus (CS+E, CS-, CS+U).||||0.040
72460067|NCT02069366|144443144|SUPERIORITY||||||>|0.05||||||RM-ANOVA. Significance threshold p\<0.05, FWE-corrected.|ANOVA|RM-ANOVA with group and stimulus factors.||This analysis corresponds to the row 'Recall CS+E Amygdala- Visit 4' in the Brain Measures outcome table. RM-ANOVA including stimulus (CS+E, CS-, CS+U).||||>0.05
72460068|NCT02069366|144443144|SUPERIORITY|||||||0.027||||||Repeated-measures ANOVA (SPM12, ROI small-volume corrected). Significance threshold p\<0.05, FWE-corrected.|ANOVA|RM-ANOVA with group and stimulus factors.||This analysis corresponds to the row 'Recall CS+E Hippocampus-Visit 4' in the Brain Measures outcome table. RM-ANOVA including stimulus (CS+E, CS-, CS+U).||||0.027
72460069|NCT02069366|144443144|SUPERIORITY|||||||0.019||||||Repeated-measures ANOVA (SPM12, ROI small-volume corrected). Significance threshold p\<0.05, FWE-corrected.|ANOVA|RM-ANOVA with group and stimulus factors.||This analysis corresponds to the row 'Recall CS+E vmPFC-Visit 4' in the Brain Measures outcome table. RM-ANOVA including stimulus (CS+E, CS-, CS+U).||||0.019
72460070|NCT02069366|144443144|SUPERIORITY||||||>|0.05||||||RM-ANOVA. Significance threshold p\<0.05, FWE-corrected.|ANOVA|RM-ANOVA with group and stimulus factors.||This analysis corresponds to the row 'Recall CS- Amygdala-Visit 4' in the Brain Measures outcome table. RM-ANOVA including stimulus (CS+E, CS-, CS+U).||||>0.05
72460071|NCT02069366|144443144|SUPERIORITY|||||||0.027||||||Repeated-measures ANOVA (SPM12, ROI small-volume corrected). Significance threshold p\<0.05, FWE-corrected.|ANOVA|RM-ANOVA with group and stimulus factors.||This analysis corresponds to the row 'Recall CS- Hippocampus-Visit 4' in the Brain Measures outcome table. RM-ANOVA including stimulus (CS+E, CS-, CS+U).||||0.027
72460072|NCT02069366|144443144|SUPERIORITY|||||||0.019||||||Repeated-measures ANOVA (SPM12, ROI small-volume corrected). Significance threshold p\<0.05, FWE-corrected.|ANOVA|RM-ANOVA with group and stimulus factors.||This analysis corresponds to the row 'Recall CS- vmPFC-Visit 4' in the Brain Measures outcome table. RM-ANOVA including stimulus (CS+E, CS-, CS+U).||||0.019
72460073|NCT02069366|144443144|SUPERIORITY||||||>|0.05||||||RM-ANOVA. Significance threshold p\<0.05, FWE-corrected.|ANOVA|RM-ANOVA with group and stimulus factors.||This analysis corresponds to the row 'Recall CS+U Amygdala-Visit 4' in the Brain Measures outcome table. RM-ANOVA including stimulus (CS+E, CS-, CS+U).||||>0.05
72370542|NCT00488683|144251633|SUPERIORITY_OR_OTHER||R-square|0.06||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and memory B cells rise from pre-booster to one month after booster vaccination for the serogroup A||||
72460074|NCT02069366|144443144|SUPERIORITY|||||||0.027||||||Repeated-measures ANOVA (SPM12, ROI small-volume corrected). Significance threshold p\<0.05, FWE-corrected.|ANOVA|RM-ANOVA with group and stimulus factors.||This analysis corresponds to the row 'Recall CS+U Hippocampus-Visit 4' in the Brain Measures outcome table. RM-ANOVA including stimulus (CS+E, CS-, CS+U).||||0.027
72460075|NCT02069366|144443144|SUPERIORITY|||||||0.019||||||Repeated-measures ANOVA (SPM12, ROI small-volume corrected). Significance threshold p\<0.05, FWE-corrected.|ANOVA|RM-ANOVA with group and stimulus factors.||This analysis corresponds to the row 'Recall CS+U vmPFC-Visit 4' in the Brain Measures outcome table. RM-ANOVA including stimulus (CS+E, CS-, CS+U).||||0.019
72460076|NCT02069366|144443144|SUPERIORITY||||||>|0.05||||||RM-ANOVA. Significance threshold p\<0.05, FWE-corrected.|ANOVA|RM-ANOVA with group and stimulus factors.||This analysis corresponds to the row 'Renewal CS+E Amygdala-Visit 4' in the Brain Measures outcome table. RM-ANOVA including stimulus (CS+E, CS-, CS+U).||||>0.05
72460077|NCT02069366|144443144|SUPERIORITY||||||>|0.05||||||RM-ANOVA. Significance threshold p\<0.05, FWE-corrected.|ANOVA|RM-ANOVA with group and stimulus factors.||This analysis corresponds to the row 'Renewal CS+E Hippocampus- Visit 4' in the Brain Measures outcome table. RM-ANOVA including stimulus (CS+E, CS-, CS+U).||||>0.05
72460078|NCT02069366|144443144|SUPERIORITY|||||||0.025||||||Repeated-measures ANOVA (SPM12, ROI small-volume corrected). Significance threshold p\<0.05, FWE-corrected.|ANOVA|RM-ANOVA with group and stimulus factors.||This analysis corresponds to the row 'Renewal CS+E vmPFC- Visit 4' in the Brain Measures outcome table. RM-ANOVA including stimulus (CS+E, CS-, CS+U).||||0.025
72460079|NCT02069366|144443144|SUPERIORITY||||||>|0.05||||||RM-ANOVA. Significance threshold p\<0.05, FWE-corrected.|ANOVA|RM-ANOVA with group and stimulus factors.||This analysis corresponds to the row 'Renewal CS- Amygdala- Visit 4' in the Brain Measures outcome table. RM-ANOVA including stimulus (CS+E, CS-, CS+U).||||>0.05
72460080|NCT02069366|144443144|SUPERIORITY||||||>|0.05||||||RM-ANOVA. Significance threshold p\<0.05, FWE-corrected.|ANOVA|RM-ANOVA with group and stimulus factors.||This analysis corresponds to the row 'Renewal CS- Hippocampus-Visit 4' in the Brain Measures outcome table. RM-ANOVA including stimulus (CS+E, CS-, CS+U).||||>0.05
72460081|NCT02069366|144443144|SUPERIORITY||||||>|0.05||||||RM-ANOVA. Significance threshold p\<0.05, FWE-corrected.|ANOVA|RM-ANOVA with group and stimulus factors.||This analysis corresponds to the row 'Renewal CS- vmPFC-Visit 4' in the Brain Measures outcome table. RM-ANOVA including stimulus (CS+E, CS-, CS+U).||||>0.05
72392538|NCT02155608|144292439|SUPERIORITY|||||||0.68||||||p \< .05 for statistical significance.|Mixed Models Analysis|Time: F = .17, df = 1/50.||Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5.||||.68
72460082|NCT02069366|144443144|SUPERIORITY||||||>|0.05||||||RM-ANOVA. Significance threshold p\<0.05, FWE-corrected.|ANOVA|RM-ANOVA with group and stimulus factors.||This analysis corresponds to the row 'Renewal CS+U Amygdala-Visit 4' in the Brain Measures outcome table. RM-ANOVA including stimulus (CS+E, CS-, CS+U).||||>0.05
72460083|NCT02069366|144443144|SUPERIORITY||||||>|0.05||||||RM-ANOVA. Significance threshold p\<0.05, FWE-corrected.|ANOVA|RM-ANOVA with group and stimulus factors.||This analysis corresponds to the row 'Renewal CS+U Hippocampus-Visit 4' in the Brain Measures outcome table. RM-ANOVA including stimulus (CS+E, CS-, CS+U).||||>0.05
72460084|NCT02069366|144443144|SUPERIORITY|||||||0.025||||||Repeated-measures ANOVA (SPM12, ROI small-volume corrected). Significance threshold p\<0.05, FWE-corrected.|ANOVA|RM-ANOVA with group and stimulus factors.||This analysis corresponds to the row 'Renewal CS+U vmPFC-Visit 4' in the Brain Measures outcome table. RM-ANOVA including stimulus (CS+E, CS-, CS+U).||||0.025
72460085|NCT02069366|144443145|SUPERIORITY||||||>|0.05||||||Chi-square test of independence; significance threshold p\<0.05.|Chi-squared|3 (response categories) × 6 (groups) contingency table; df=10.||This analysis corresponds to the row 'Acquisition CS+E Early- Visit 2' in the Expectancy Ratings outcome table. Chi-square test comparing distribution of Yes/No/I don't know responses across 6 groups.||||>0.05
72460086|NCT02069366|144443145|SUPERIORITY||||||>|0.05||||||Chi-square test of independence; significance threshold p\<0.05.|Chi-squared|3 (response categories) × 6 (groups) contingency table; df=10.||This analysis corresponds to the row 'Acquisition CS+U Early- Visit 2' in the Expectancy Ratings outcome table. Chi-square test comparing distribution of Yes/No/I don't know responses across 6 groups.||||>0.05
72460087|NCT02069366|144443145|SUPERIORITY||||||>|0.05||||||Chi-square test of independence; significance threshold p\<0.05.|Chi-squared|3 (response categories) × 6 (groups) contingency table; df=10.||This analysis corresponds to the row 'Acquisition CS-Early- Visit 2' in the Expectancy Ratings outcome table. Chi-square test comparing distribution of Yes/No/I don't know responses across 6 groups.||||>0.05
72460088|NCT02069366|144443145|SUPERIORITY||||||>|0.05||||||Chi-square test of independence; significance threshold p\<0.05.|Chi-squared|3 (response categories) × 6 (groups) contingency table; df=10.||This analysis corresponds to the row 'Acquisition CS+E Late- Visit 2' in the Expectancy Ratings outcome table. Chi-square test comparing distribution of Yes/No/I don't know responses across 6 groups.||||>0.05
72460089|NCT02069366|144443145|SUPERIORITY||||||>|0.05||||||Chi-square test of independence; significance threshold p\<0.05.|Chi-squared|3 (response categories) × 6 (groups) contingency table; df=10.||This analysis corresponds to the row 'Acquisition CS+U Late- Visit 2' in the Expectancy Ratings outcome table. Chi-square test comparing distribution of Yes/No/I don't know responses across 6 groups.||||>0.05
72501087|NCT01381094|144532154|SUPERIORITY||||||<|0.0001|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 4).||||<0.0001
72501088|NCT01381094|144532154|SUPERIORITY||||||=|0.0401|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 4).||||=0.0401
72501089|NCT01381094|144532154|SUPERIORITY||||||=|0.0042|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 6).||||=0.0042
72392539|NCT02155608|144292439|SUPERIORITY|||||||0.16||||||p \< .05 for statistical significance.|Mixed Models Analysis|Group \* time: F = 2.05, df = 1/50.||Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5.||||.16
72460090|NCT02069366|144443145|SUPERIORITY||||||>|0.05||||||Chi-square test of independence; significance threshold p\<0.05.|Chi-squared|3 (response categories) × 6 (groups) contingency table; df=10.||This analysis corresponds to the row 'Acquisition CS- Late- Visit 2' in the Expectancy Ratings outcome table. Chi-square test comparing distribution of Yes/No/I don't know responses across 6 groups.||||>0.05
72460091|NCT02069366|144443145|SUPERIORITY||||||>|0.05||||||Chi-square test of independence; significance threshold p\<0.05.|Chi-squared|3 (response categories) × 6 (groups) contingency table; df=10.||This analysis corresponds to the row 'Extinction CS+E Early- Visit 3' in the Expectancy Ratings outcome table. Chi-square test comparing distribution of Yes/No/I don't know responses across 6 groups.||||>0.05
72501090|NCT01381094|144532154|SUPERIORITY||||||<|0.0001|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 6).||||<0.0001
72392540|NCT02155608|144292440|SUPERIORITY|||||||0.91||||||p \< .05 for statistical significance.|Mixed Models Analysis|Group: F = .01, df = 1/56.||Phase 1a: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects.||||.91
72460092|NCT02069366|144443145|SUPERIORITY||||||>|0.05||||||Chi-square test of independence; significance threshold p\<0.05.|Chi-squared|3 (response categories) × 6 (groups) contingency table; df=10.||This analysis corresponds to the row 'Extinction CS- Early- Visit 3' in the Expectancy Ratings outcome table. Chi-square test comparing distribution of Yes/No/I don't know responses across 6 groups.||||>0.05
72501091|NCT01381094|144532154|SUPERIORITY||||||=|0.0002|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 6).||||=0.0002
72392541|NCT02155608|144292440|SUPERIORITY|||||||0.15||||||p \< .05 for statistical significance.|Mixed Models Analysis|Time: F = 2.12, df = .15||Phase 1a: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects.||||.15
72501092|NCT01381094|144532154|SUPERIORITY||||||<|0.0001|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 6).||||<0.0001
72501093|NCT01381094|144532154|SUPERIORITY||||||=|0.0422|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 6).||||=0.0422
72563301|NCT00442546|144658167|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.002|STANDARD_ERROR_OF_MEAN|0.33||0.9942||95.0|-0.648|0.652|||ANOVA||Mean difference (final values) = Least squares mean difference|48 hours||0.652|-0.648|0.9942
72563302|NCT00442546|144658167|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.206|STANDARD_ERROR_OF_MEAN|0.332||0.5352||95.0|-0.859|0.448|||ANOVA||Mean difference (final values) = Least squares mean difference|48 hours||0.448|-0.859|0.5352
72563303|NCT00442546|144658167|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.094|STANDARD_ERROR_OF_MEAN|0.382||0.8055||95.0|-0.662|0.85|||ANOVA||Mean difference (final values) = Least squares mean difference|72 hours||0.850|-0.662|0.8055
72563304|NCT00442546|144658167|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.446|STANDARD_ERROR_OF_MEAN|0.391||0.256||95.0|-1.22|0.327|||ANOVA||Mean difference (final values) = Least squares mean difference|72 hours||0.327|-1.220|0.2560
72563305|NCT00442546|144658167|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.102|STANDARD_ERROR_OF_MEAN|0.641||0.8744||95.0|-1.184|1.387|||ANOVA||Mean difference (final values) = Least squares mean difference|96 hours||1.387|-1.184|0.8744
72563306|NCT00442546|144658167|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.614|STANDARD_ERROR_OF_MEAN|0.616||0.0115||95.0|-2.851|-0.378|||ANOVA||Mean difference (final values) = Least squares mean difference|96 hours||-0.378|-2.851|0.0115
72501094|NCT01381094|144532154|SUPERIORITY||||||=|0.0232|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).||||=0.0232
72563307|NCT00442546|144658167|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.077|STANDARD_ERROR_OF_MEAN|1.155||0.9497||95.0|-3.047|2.893|||ANOVA||Mean difference (final values) = Least squares mean difference|120 hours||2.893|-3.047|0.9497
72563308|NCT00442546|144658167|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.347|STANDARD_ERROR_OF_MEAN|1.992||0.5288||95.0|-6.467|3.773|||ANOVA||Mean difference (final values) = Least squares mean difference|120 hours||3.773|-6.467|0.5288
72370543|NCT00488683|144251633|SUPERIORITY_OR_OTHER||R-square|0.01||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between memory B cells one month after primary vaccination and memory B cells rise from pre-booster to one month after booster vaccination for the serogroup A||||
72501095|NCT01381094|144532154|SUPERIORITY||||||=|0.0243|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).||||=0.0243
72501096|NCT01381094|144532154|SUPERIORITY||||||=|0.0001|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).||||=0.0001
72501097|NCT01381094|144532154|SUPERIORITY||||||=|0.1089|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).||||=0.1089
72501098|NCT01381094|144532154|SUPERIORITY||||||=|0.0833|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).||||=0.0833
72501099|NCT01381094|144532156|SUPERIORITY||||||=|0.5456|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||||||=0.5456
72563309|NCT00442546|144658167|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.296|STANDARD_ERROR_OF_MEAN|0.262||0.2595||95.0|-0.813|0.22|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2||0.220|-0.813|0.2595
72563310|NCT00442546|144658167|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.013|STANDARD_ERROR_OF_MEAN|0.27||0.9605||95.0|-0.546|0.519|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2||0.519|-0.546|0.9605
72563311|NCT00442546|144658167|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.207|STANDARD_ERROR_OF_MEAN|0.251||0.4107||95.0|-0.702|0.288|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4||0.288|-0.702|0.4107
72563312|NCT00442546|144658167|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.318|STANDARD_ERROR_OF_MEAN|0.263||0.2271||95.0|-0.836|0.2|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4||0.200|-0.836|0.2271
72563313|NCT00442546|144658167|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.015|STANDARD_ERROR_OF_MEAN|0.263||0.9552||95.0|-0.535|0.506|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET||0.506|-0.535|0.9552
72563314|NCT00442546|144658167|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.003|STANDARD_ERROR_OF_MEAN|0.268||0.9899||95.0|-0.533|0.526|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET||0.526|-0.533|0.9899
72563315|NCT00442546|144658168|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.578|STANDARD_ERROR_OF_MEAN|0.471||0.2211||95.0|-0.35|1.506|||ANOVA||Mean difference (final values) = Least squares mean difference|4 hours||1.506|-0.350|0.2211
72370544|NCT00488683|144251633|SUPERIORITY_OR_OTHER||R-square|0.13||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and memory B cells rise from pre-booster to one month after booster vaccination for the serogroup C||||
72392542|NCT02155608|144292440|SUPERIORITY|||||||0.64||||||p \< .05 for statistical significance.|Mixed Models Analysis|Group \* time: F = .21, df = 1/56.||Phase 1a: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects.||||.64
72460093|NCT02069366|144443145|SUPERIORITY||||||>|0.05||||||Chi-square test of independence; significance threshold p\<0.05.|Chi-squared|3 (response categories) × 6 (groups) contingency table; df=10.||This analysis corresponds to the row 'Extinction CS+E Late-Visit 3' in the Expectancy Ratings outcome table. Chi-square test comparing distribution of Yes/No/I don't know responses across 6 groups.||||>0.05
72460094|NCT02069366|144443145|SUPERIORITY|||||||0.04||||||Chi-square test of independence; significance threshold p\<0.05.|Chi-squared|3 (response categories) × 6 (groups) contingency table; df=10.||This analysis corresponds to the row 'Extinction CS- Late- Visit 3' in the Expectancy Ratings outcome table. Chi-square test comparing distribution of Yes/No/I don't know responses across 6 groups.||||0.04
72460095|NCT02069366|144443145|SUPERIORITY||||||>|0.05||||||Chi-square test of independence; significance threshold p\<0.05.|Chi-squared|3 (response categories) × 6 (groups) contingency table; df=10||This analysis corresponds to the row 'Recall CS+E Early-Visit 4' in the Expectancy Ratings outcome table. Chi-square test comparing distribution of Yes/No/I don't know responses across 6 groups.||||>0.05
72460096|NCT02069366|144443145|SUPERIORITY||||||>|0.05||||||Chi-square test of independence; significance threshold p\<0.05.|Chi-squared|3 (response categories) × 6 (groups) contingency table; df=10||This analysis corresponds to the row 'Recall CS+U Early-Visit 4' in the Expectancy Ratings outcome table. Chi-square test comparing distribution of Yes/No/I don't know responses across 6 groups.||||>0.05
72460097|NCT02069366|144443145|SUPERIORITY||||||>|0.05||||||Chi-square test of independence; significance threshold p\<0.05.|Chi-squared|3 (response categories) × 6 (groups) contingency table; df=10||This analysis corresponds to the row 'Recall CS- Early-Visit 4' in the Expectancy Ratings outcome table. Chi-square test comparing distribution of Yes/No/I don't know responses across 6 groups.||||>0.05
72460098|NCT02069366|144443145|SUPERIORITY||||||>|0.05||||||Chi-square test of independence; significance threshold p\<0.05.|Chi-squared|3 (response categories) × 6 (groups) contingency table; df=10||This analysis corresponds to the row 'Recall CS+E Late-Visit 4' in the Expectancy Ratings outcome table. Chi-square test comparing distribution of Yes/No/I don't know responses across 6 groups.||||>0.05
72460099|NCT02069366|144443145|SUPERIORITY||||||>|0.05||||||Chi-square test of independence; significance threshold p\<0.05.|Chi-squared|3 (response categories) × 6 (groups) contingency table; df=10||This analysis corresponds to the row 'Recall CS+U Late-Visit 4' in the Expectancy Ratings outcome table. Chi-square test comparing distribution of Yes/No/I don't know responses across 6 groups.||||>0.05
72460100|NCT02069366|144443145|SUPERIORITY|||||||0.033||||||Chi-square test of independence; significance threshold p\<0.05.|Chi-squared|3 (response categories) × 6 (groups) contingency table; df=10||This analysis corresponds to the row 'Recall CS- Late-Visit 4' in the Expectancy Ratings outcome table. Chi-square test comparing distribution of Yes/No/I don't know responses across 6 groups.||||0.033
72460101|NCT02069366|144443145|SUPERIORITY||||||>|0.05||||||Chi-square test of independence; significance threshold p\<0.05.|Chi-squared|3 (response categories) × 6 (groups) contingency table; df=10||This analysis corresponds to the row 'Renewal CS+E Early-Visit 4' in the Expectancy Ratings outcome table. Chi-square test comparing distribution of Yes/No/I don't know responses across 6 groups.||||>0.05
72460102|NCT02069366|144443145|SUPERIORITY||||||>|0.05||||||Chi-square test of independence; significance threshold p\<0.05.|Chi-squared|3 (response categories) × 6 (groups) contingency table; df=10||This analysis corresponds to the row 'Renewal CS+U Early-Visit 4' in the Expectancy Ratings outcome table. Chi-square test comparing distribution of Yes/No/I don't know responses across 6 groups.||||>0.05
72460103|NCT02069366|144443145|SUPERIORITY||||||>|0.05||||||Chi-square test of independence; significance threshold p\<0.05.|Chi-squared|3 (response categories) × 6 (groups) contingency table; df=10||This analysis corresponds to the row 'Renewal CS- Early-Visit 4' in the Expectancy Ratings outcome table. Chi-square test comparing distribution of Yes/No/I don't know responses across 6 groups.||||>0.05
72460104|NCT02069366|144443145|SUPERIORITY||||||>|0.05||||||Chi-square test of independence; significance threshold p\<0.05.|Chi-squared|3 (response categories) × 6 (groups) contingency table; df=10||This analysis corresponds to the row 'Renewal CS+E Late-Visit 4' in the Expectancy Ratings outcome table. Chi-square test comparing distribution of Yes/No/I don't know responses across 6 groups.||||>0.05
72460105|NCT02069366|144443145|SUPERIORITY||||||>|0.05||||||Chi-square test of independence; significance threshold p\<0.05.|Chi-squared|3 (response categories) × 6 (groups) contingency table; df=10||This analysis corresponds to the row 'Renewal CS+U Late-Visit 4' in the Expectancy Ratings outcome table. Chi-square test comparing distribution of Yes/No/I don't know responses across 6 groups.||||>0.05
72460106|NCT02069366|144443145|SUPERIORITY||||||>|0.05||||||Chi-square test of independence; significance threshold p\<0.05.|Chi-squared|3 (response categories) × 6 (groups) contingency table; df=10||This analysis corresponds to the row 'Renewal CS- Late-Visit 4' in the Expectancy Ratings outcome table. Chi-square test comparing distribution of Yes/No/I don't know responses across 6 groups.||||>0.05
72501100|NCT01381094|144532156|SUPERIORITY||||||=|0.0053|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||||||=0.0053
72460107|NCT02069366|144443146|SUPERIORITY||||||>|0.05||||||Significance threshold p\<0.05.|ANOVA|Group factor at specified phase/timepoint.||This analysis corresponds to the row 'Extinction Learning Pre- Visit 3' in the SUDS outcome table. ANOVA comparing mean SUDS ratings across 6 groups at the specified phase/timepoint.||||>0.05
72460108|NCT02069366|144443146|SUPERIORITY||||||>|0.05||||||Significance threshold p\<0.05.|ANOVA|Group factor at specified phase/timepoint.||This analysis corresponds to the row 'Extinction Learning Mid-Visit 3' in the SUDS outcome table. ANOVA comparing mean SUDS ratings across 6 groups at the specified phase/timepoint.||||>0.05
72501101|NCT01381094|144532156|SUPERIORITY||||||<|0.0001|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||||||<0.0001
72392543|NCT02155608|144292440|SUPERIORITY|||||||0.66||||||p \< .05 for statistical significance.|Mixed Models Analysis|Group: F = .20, df = 1/59.||Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5.||||.66
72501102|NCT01381094|144532156|SUPERIORITY||||||=|0.004|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||||||=0.0040
72501103|NCT01381094|144532156|SUPERIORITY||||||=|0.2017|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||||||=0.2017
72501104|NCT00486902|144532172|SUPERIORITY_OR_OTHER|||||||0.86||95.0|||||Fisher Exact|||Sample size was determined assuming an incidence of breakthrough pain of 75% and an absolute difference between groups of -20 to +15%. This rate of request for analgesia in the first 24 h was based on data from a parallel study utilizing the same multimodal postoperative pain regimen for cesarean delivery. Group sample sizes of 90 achieve 80% power to detect this difference using the two-sided Z test with pooled variance. The significance level of the test was targeted at 0.05.||||0.86
72501105|NCT00486902|144532173|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.02
72501106|NCT00486902|144532174|SUPERIORITY_OR_OTHER|||||||0.24||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.24
72501107|NCT00486902|144532175|SUPERIORITY_OR_OTHER|||||||0.87||95.0|||||Fisher Exact|||||||0.87
72501108|NCT00486902|144532176|SUPERIORITY_OR_OTHER|||||||0.9||95.0|||||Fisher Exact|||||||0.90
72501109|NCT00486902|144532177|SUPERIORITY_OR_OTHER|||||||0.24||95.0|||||Fisher Exact|||||||0.24
72563316|NCT00442546|144658168|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.809|STANDARD_ERROR_OF_MEAN|0.477||0.0916||95.0|-1.75|0.132|||ANOVA||Mean difference (final values) = Least squares mean difference|4 hours||0.132|-1.750|0.0916
72501110|NCT00486902|144532178|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|||||||1.0
72501111|NCT00486902|144532179|SUPERIORITY_OR_OTHER||Median Difference (Net)|-0.6||||0.02|TWO_SIDED|95.0|-1.1|-0.09|||Wilcoxon (Mann-Whitney)|||||-0.09|-1.1|0.02
72501112|NCT03895203|144532193|SUPERIORITY||Odds Ratio (OR)|7.082|||<|0.001|TWO_SIDED|95.0|4.583|10.943|||Regression, Logistic|||||10.943|4.583|<0.001
72563317|NCT00442546|144658168|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.036|STANDARD_ERROR_OF_MEAN|0.42||0.9312||95.0|-0.863|0.791|||ANOVA||Mean difference (final values) = Least squares mean difference|8 hours||0.791|-0.863|0.9312
72563318|NCT00442546|144658168|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.591|STANDARD_ERROR_OF_MEAN|0.425||0.1658||95.0|-1.428|0.247|||ANOVA||Mean difference (final values) = Least squares mean difference|8 hours||0.247|-1.428|0.1658
72563319|NCT00442546|144658168|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.005|STANDARD_ERROR_OF_MEAN|0.483||0.9921||95.0|-0.958|0.948|||ANOVA||Mean difference (final values) = Least squares mean difference|12 hours||0.948|-0.958|0.9921
72392544|NCT02155608|144292440|SUPERIORITY|||||||0.48||||||p \< .05 for statistical significance.|Mixed Models Analysis|Time: F = .50, df = 1/47.||Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5.||||.48
72501113|NCT03895203|144532194|SUPERIORITY||Least square (LS) mean difference|-0.187|||<|0.001|TWO_SIDED|95.0|-0.249|-0.125|||ANCOVA|||||-0.125|-0.249|<0.001
72501114|NCT03895203|144532196|SUPERIORITY||Odds Ratio (OR)|63.039|||<|0.001|TWO_SIDED|95.0|22.211|178.918|||Regression, Logistic|||||178.918|22.211|<0.001
72501115|NCT03895203|144532197|SUPERIORITY||LS mean difference|4.337|||<|0.001|TWO_SIDED|95.0|3.229|5.444|||ANCOVA|||||5.444|3.229|<0.001
72501116|NCT03895203|144532198|SUPERIORITY||Odds Ratio (OR)|5.447|||<|0.001|TWO_SIDED|95.0|3.668|8.088|||Regression, Logistic|||||8.088|3.668|<0.001
72501117|NCT03895203|144532199|SUPERIORITY||LS mean difference|-0.327||||0.001|TWO_SIDED|95.0|-0.524|-0.13|||ANOVA|||||-0.130|-0.524|0.001
72501118|NCT03895203|144532200|SUPERIORITY||Odds Ratio (OR)|1.904||||0.008|TWO_SIDED|95.0|1.18|3.074|||Regression, Logistic|||||3.074|1.180|0.008
72501119|NCT03895203|144532201|SUPERIORITY||Odds Ratio (OR)|3.437||||0.002|TWO_SIDED|95.0|1.559|7.574|||Regression, Logistic|||||7.574|1.559|0.002
72501120|NCT03895203|144532203|SUPERIORITY||LS mean difference|-0.281||||0.001|TWO_SIDED|95.0|-0.452|-0.111|||ANCOVA|||||-0.111|-0.452|0.001
72501121|NCT00996840|144532233|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.562|STANDARD_ERROR_OF_MEAN|0.228|||TWO_SIDED|95.0|0.357|0.885||||||Comparison at 6 h post first dose||0.885|0.357|
72501122|NCT00996840|144532233|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.612|STANDARD_ERROR_OF_MEAN|0.281|||TWO_SIDED|95.0|0.349|1.072||||||Comparison at 12 h post first dose||1.072|0.349|
72501123|NCT00996840|144532233|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.518|STANDARD_ERROR_OF_MEAN|0.319|||TWO_SIDED|95.0|0.274|0.981||||||Comparison at 18 h post first dose||0.981|0.274|
72501124|NCT00996840|144532233|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.416|STANDARD_ERROR_OF_MEAN|0.326|||TWO_SIDED|95.0|0.217|0.796||||||Comparison at 24 h post first dose||0.796|0.217|
72501125|NCT00996840|144532233|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.517|STANDARD_ERROR_OF_MEAN|0.34|||TWO_SIDED|95.0|0.262|1.021||||||Comparison at 48 h post first dose||1.021|0.262|
72501126|NCT00996840|144532233|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.661|STANDARD_ERROR_OF_MEAN|0.41|||TWO_SIDED|95.0|0.291|1.503||||||Comparison at 72 h post first dose||1.503|0.291|
72563320|NCT00442546|144658168|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.715|STANDARD_ERROR_OF_MEAN|0.479||0.1367||95.0|-1.66|0.229|||ANOVA||Mean difference (final values) = Least squares mean difference|12 hours||0.229|-1.660|0.1367
72563321|NCT00442546|144658168|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.336|STANDARD_ERROR_OF_MEAN|0.364||0.3561||95.0|-1.053|0.38|||ANOVA||Mean difference (final values) = Least squares mean difference|24 hours||0.380|-1.053|0.3561
72563322|NCT00442546|144658168|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.291|STANDARD_ERROR_OF_MEAN|0.366||0.426||95.0|-1.012|0.429|||ANOVA||Mean difference (final values) = Least squares mean difference|24 hours||0.429|-1.012|0.4260
72563323|NCT00442546|144658168|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.105|STANDARD_ERROR_OF_MEAN|0.41||0.7975||95.0|-0.703|0.914|||ANOVA||Mean difference (final values) = Least squares mean difference|32 hours||0.914|-0.703|0.7975
72392545|NCT02155608|144292440|SUPERIORITY|||||||0.81||||||p \< .05 for statistical significance.|Mixed Models Analysis|Group \* time: F = .06, df = 1/47.||Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5.||||.81
72460109|NCT02069366|144443146|SUPERIORITY||||||>|0.05||||||Significance threshold p\<0.05.|ANOVA|Group factor at specified phase/timepoint.||This analysis corresponds to the row 'Extinction Learning Post-Visit 3' in the SUDS outcome table. ANOVA comparing mean SUDS ratings across 6 groups at the specified phase/timepoint.||||>0.05
72460110|NCT02069366|144443146|SUPERIORITY||||||>|0.05||||||Significance threshold p\<0.05.|ANOVA|Group factor at specified phase/timepoint.||This analysis corresponds to the row 'Recall Pre-Visit 4' in the SUDS outcome table. ANOVA comparing mean SUDS ratings across 6 groups at the specified phase/timepoint.||||>0.05
72460111|NCT02069366|144443146|SUPERIORITY||||||>|0.05||||||Significance threshold p\<0.05.|ANOVA|Group factor at specified phase/timepoint.||This analysis corresponds to the row 'Recall Mid-Visit 4' in the SUDS outcome table. ANOVA comparing mean SUDS ratings across 6 groups at the specified phase/timepoint.||||>0.05
72460112|NCT02069366|144443146|SUPERIORITY||||||>|0.05||||||Significance threshold p\<0.05.|ANOVA|Group factor at specified phase/timepoint.||This analysis corresponds to the row 'Recall Post-Visit 4' in the SUDS outcome table. ANOVA comparing mean SUDS ratings across 6 groups at the specified phase/timepoint.||||>0.05
72460113|NCT02069366|144443146|SUPERIORITY||||||>|0.05||||||Significance threshold p\<0.05.|ANOVA|Group factor at specified phase/timepoint.||This analysis corresponds to the row 'Renewal Pre-Visit 4' in the SUDS outcome table. ANOVA comparing mean SUDS ratings across 6 groups at the specified phase/timepoint.||||>0.05
72392546|NCT02155608|144292441|SUPERIORITY|||||||0.89||||||p \< .05 for statistical significance.|Mixed Models Analysis|Group: F = .02, df = 1/55.||Phase 1a: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects.||||.89
72460114|NCT02069366|144443146|SUPERIORITY||||||>|0.05||||||Significance threshold p\<0.05.|ANOVA|Group factor at specified phase/timepoint.||This analysis corresponds to the row 'Renewal Mid-Visit 4' in the SUDS outcome table. ANOVA comparing mean SUDS ratings across 6 groups at the specified phase/timepoint.||||>0.05
72460115|NCT02069366|144443146|SUPERIORITY||||||>|0.05||||||Significance threshold p\<0.05.|ANOVA|Group factor at specified phase/timepoint.||This analysis corresponds to the row 'Renewal Post-Visit 4' in the SUDS outcome table. ANOVA comparing mean SUDS ratings across 6 groups at the specified phase/timepoint.||||>0.05
72460116|NCT01951105|144443158|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.0
72501127|NCT00996840|144532233|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.908|STANDARD_ERROR_OF_MEAN|0.454|||TWO_SIDED|95.0|0.366|2.254||||||Comparison at 96 h post first dose||2.254|0.366|
72501128|NCT00996840|144532233|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.768|STANDARD_ERROR_OF_MEAN|0.195|||TWO_SIDED|95.0|0.52|1.134||||||Comparison at 6 h post first dose||1.134|0.520|
72501129|NCT00996840|144532233|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.701|STANDARD_ERROR_OF_MEAN|0.248|||TWO_SIDED|95.0|0.427|1.15||||||Comparison at 12 h post first dose||1.150|0.427|
72501130|NCT00996840|144532233|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.578|STANDARD_ERROR_OF_MEAN|0.282|||TWO_SIDED|95.0|0.329|1.015||||||Comparison at 18 h post first dose||1.015|0.329|
72460117|NCT01601821|144443160|SUPERIORITY_OR_OTHER||percent difference|-2.0||||0.341|TWO_SIDED|90.0|-5.5|1.5|||Chi-squared|||Chi-square test was used to test superiority of arm CsA+Rapamune+CS versus arm CsA+MMF+CS.||1.5|-5.5|0.341
72460118|NCT01601821|144443161|SUPERIORITY_OR_OTHER|||||||0.87|TWO_SIDED|||||Statistical testing was based on 5% significance level.|ANOVA|||Month 3: One-way analysis of variance (ANOVA) was used to test the difference.||||0.870
72501131|NCT00996840|144532233|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.41|STANDARD_ERROR_OF_MEAN|0.287|||TWO_SIDED|95.0|0.231|0.728||||||Comparison at 24 h post first dose||0.728|0.231|
72501132|NCT00996840|144532233|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.896|STANDARD_ERROR_OF_MEAN|0.308|||TWO_SIDED|95.0|0.484|1.657||||||Comparison at 48 h post first dose||1.657|0.484|
72392547|NCT02155608|144292441|SUPERIORITY|||||||0.14||||||p \< .05 for statistical significance.|Mixed Models Analysis|Time: F = 2.28, df = 1/55.||Phase 1a: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects.||||.14
72460119|NCT01601821|144443161|SUPERIORITY_OR_OTHER|||||||0.381|TWO_SIDED|||||Statistical testing was based on 5% significance level.|ANOVA|||Month 6: One-way ANOVA was used to test the difference.||||0.381
72460120|NCT01601821|144443161|SUPERIORITY_OR_OTHER|||||||0.096|TWO_SIDED|||||Statistical testing was based on 5% significance level.|ANOVA|||Month 12: One-way ANOVA was used to test the difference.||||0.096
72460121|NCT01601821|144443162|SUPERIORITY_OR_OTHER|||||||0.979|TWO_SIDED|||||Statistical testing was based on 5% significance level.|ANOVA|||Month 3: One-way ANOVA was used to test the difference.||||0.979
72460122|NCT01601821|144443162|SUPERIORITY_OR_OTHER|||||||0.66|TWO_SIDED|||||Statistical testing was based on 5% significance level.|ANOVA|||Month 6: One-way ANOVA was used to test the difference.||||0.660
72460123|NCT01601821|144443162|SUPERIORITY_OR_OTHER|||||||0.518|TWO_SIDED|||||Statistical testing was based on 5% significance level.|ANOVA|||Month 12: One-way ANOVA was used to test the difference.||||0.518
72501133|NCT00996840|144532233|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.739|STANDARD_ERROR_OF_MEAN|0.374|||TWO_SIDED|95.0|0.35|1.563||||||Comparison at 72 h post first dose||1.563|0.350|
72563324|NCT00442546|144658168|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.162|STANDARD_ERROR_OF_MEAN|0.412||0.6947||95.0|-0.65|0.974|||ANOVA||Mean difference (final values) = Least squares mean difference|32 hours||0.974|-0.650|0.6947
72460124|NCT01601821|144443163|SUPERIORITY_OR_OTHER|||||||0.786|TWO_SIDED|||||Statistical testing was based on 5% significance level.|ANOVA|||Month 3: One-way ANOVA was used to test the difference.||||0.786
72460125|NCT01601821|144443163|SUPERIORITY_OR_OTHER|||||||0.738|TWO_SIDED|||||Statistical testing was based on 5% significance level.|ANOVA|||Month 6: One-way ANOVA was used to test the difference.||||0.738
72460126|NCT01601821|144443163|SUPERIORITY_OR_OTHER|||||||0.977|TWO_SIDED|||||Statistical testing was based on 5% significance level.|ANOVA|||Month 12: One-way ANOVA was used to test the difference.||||0.977
72460127|NCT01601821|144443164|SUPERIORITY_OR_OTHER|||||||0.999|TWO_SIDED|||||Statistical testing was based on 5% significance level.|Fisher Exact|||Fisher's exact test was used to test the difference.||||0.999
72460128|NCT01601821|144443166|SUPERIORITY_OR_OTHER|||||||0.276|TWO_SIDED|||||Statistical testing was based on 5% significance level.|Fisher Exact|||Fisher's exact test was used to test the difference.||||0.276
72501134|NCT00996840|144532233|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|1.56|STANDARD_ERROR_OF_MEAN|0.431|||TWO_SIDED|95.0|0.659|3.697||||||Comparison at 96 h post first dose||3.697|0.659|
72392548|NCT02155608|144292441|SUPERIORITY|||||||0.8||||||p \< .05 for statistical significance.|Mixed Models Analysis|Group \* time: F = .06, df = .81.||Phase 1a: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects.||||.80
72392549|NCT02155608|144292441|SUPERIORITY|||||||0.93||||||p \< .05 for statistical significance.|Mixed Models Analysis|Group: F = .01, df = 1/58.||Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5.||||.93
72392550|NCT02155608|144292441|SUPERIORITY|||||||0.15||||||p \< .05 for statistical significance.|Mixed Models Analysis|Time: F = 2.22, df = 1/35.||Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5.||||.15
72460129|NCT01601821|144443167|SUPERIORITY_OR_OTHER|||||||0.999|TWO_SIDED|||||Statistical testing was based on 5% significance level.|Fisher Exact|||Fisher's exact test was used to test the difference.||||0.999
72392551|NCT02155608|144292441|SUPERIORITY|||||||0.28||||||p \< .05 for statistical significance.|Mixed Models Analysis|Group \* time: F = 1.23, df = 1/35.||Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5.||||.28
72460130|NCT01601821|144443168|SUPERIORITY_OR_OTHER|||||||0.868|TWO_SIDED|||||Statistical testing was based on 5% significance level.|Chi-squared|||Chi-square test was used to test the difference.||||0.868
72460131|NCT01601821|144443169|SUPERIORITY_OR_OTHER|||||||0.999|TWO_SIDED|||||Statistical testing was based on 5% significance level.|Fisher Exact|||Fisher's exact test was used to test the difference.||||0.999
72460132|NCT01601821|144443170|SUPERIORITY_OR_OTHER|||||||0.985|TWO_SIDED|||||Statistical testing was based on 5% significance level.|Chi-squared|||Chi-square test was used to test the difference.||||0.985
72460133|NCT01601821|144443171|SUPERIORITY_OR_OTHER|||||||0.172|TWO_SIDED|||||Statistical testing was based on 5% significance level.|Fisher Exact|||Fisher's exact test was used to test the difference.||||0.172
72460134|NCT01601821|144443172|SUPERIORITY_OR_OTHER|||||||0.978|TWO_SIDED|||||Statistical testing was based on 5% significance level.|Chi-squared|||Chi-square test was used to test the difference.||||0.978
72460135|NCT00887471|144443173|SUPERIORITY_OR_OTHER|||||||0.59||||||A priori threshold for statistical significance was P\<.05.|Mixed Models Analysis|||The relationship of surgical group with AHI change was evaluated by constructing a mixed linear model (MLM). The dependent variable was the logarithm of the ratio of postoperative AHI score to preoperative AHI score; this transformation was chosen in order to minimize skew of model residuals. Surgical group was introduced as a fixed factor; subject pairs constituted levels of a random blocking) factor.||||.590
72460136|NCT00887471|144443173|SUPERIORITY_OR_OTHER|||||||0.022||||||P value for the variances. The a priori threshold for statistical significance was P \< .05.|Mixed Models Analysis|||A mixed linear model was constructed as described above. Variance was estimated separately for each group.||||.022
72460137|NCT00887471|144443174|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|||The relationship of surgical group with postoperative AHI ≤ 5 was evaluated by exact conditional logistic regression, predicting AHI ≤ 5 from surgical group with subject pairs as strata.||||1.00
72460138|NCT02469155|144443175|SUPERIORITY||Least Squares Mean Difference|0.1||||0.972|TWO_SIDED|95.0|-3.39|3.51|||Mixed Models for Repeated Measure|||||3.51|-3.39|0.972
72392552|NCT02155608|144292442|SUPERIORITY|||||||0.91||||||p \< .05 for statistical significance.|Mixed Models Analysis|Group: F = .01; df = 1/46.||Phase 1a: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects.||||.91
72392553|NCT02155608|144292442|SUPERIORITY|||||||0.11||||||p \< .05 for statistical significance.|Mixed Models Analysis|Time: F = 2.62, df = 1/46.||Phase 1a: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects.||||.11
72392554|NCT02155608|144292442|SUPERIORITY|||||||0.4||||||p \< .05 for statistical significance.|Mixed Models Analysis|Group \* time: F = .71; df = .40.||Phase 1a: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects.||||.40
72392555|NCT02155608|144292442|SUPERIORITY|||||||0.49||||||p \< .05 for statistical significance.|Mixed Models Analysis|Group: F = .48. df = 1/55.||Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5.||||.49
72460139|NCT02469155|144443175|SUPERIORITY||Least Squares Mean Difference|0.5||||0.789|TWO_SIDED|95.0|-2.92|3.84|||Mixed Effects Model for Repeated Measure|||||3.84|-2.92|0.789
72460140|NCT00442559|144443177|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.16||||0.015|TWO_SIDED|95.0|-0.29|-0.03|||t-test, 2 sided|||Change from BL to Week 12 - Montelukast. The difference in mean change from baseline to 12 weeks in daytime asthma symptom score was tested by paired t-test (H0: difference =0) for the Montelukast treatment group. Subjects in this analysis: N=24 subjects for the within arm (single arm) comparison between BL and Week 12 scores.||-0.03|-0.29|0.015
72460141|NCT00442559|144443177|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.16||||0.027|TWO_SIDED|95.0|-0.3|-0.02|||t-test, 2 sided|||Change from BL to Week 12 - ICS. The difference in mean change from baseline to 12 weeks in daytime asthma symptom score was tested by paired t-test (H0: difference =0) for the ICS treatment group. Subjects in this analysis: N=29 subjects for the within arm (single arm) comparison between BL and Week 12 scores.||-0.02|-0.3|0.027
72460142|NCT00442559|144443178|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.21||||0.006|TWO_SIDED|95.0|-0.36|-0.07|||t-test, 2 sided|||Change from BL to Week 12 - Montelukast. The difference in mean change from baseline to 12 weeks in daily allergic rhinitis symptom score was tested by paired t-test (H0: difference =0) for the Montelukast treatment group. Subjects in this analysis: N=24 subjects for the within arm (single arm) comparison between BL and Week 12 scores.||-0.07|-0.36|0.006
72392556|NCT02155608|144292442|SUPERIORITY|||||||0.18||||||p \< .05 for statistical significance.|Mixed Models Analysis|Time: F = 1.87, df = 1/55.||Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5.||||.18
72392557|NCT02155608|144292442|SUPERIORITY|||||||0.72||||||p \< .05 for statistical significance.|Mixed Models Analysis|Group \* time: F = .13, df = 1/38.||Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5.||||.72
72460143|NCT00442559|144443178|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.12||||0.032|TWO_SIDED|95.0|-0.24|-0.01|||t-test, 2 sided|||Change from BL to Week 12 - ICS. The difference in mean change from baseline to 12 weeks in daily allergic rhinitis symptom score was tested by paired t-test (H0: difference =0) for the ICS treatment group. Subjects in this analysis: N=28 subjects for the within arm (single arm) comparison between BL and Week 12 scores.||-0.01|-0.24|0.032
72460144|NCT02604199|144443188|SUPERIORITY||LS Mean Difference|-0.086|STANDARD_ERROR_OF_MEAN|0.048||0.081|TWO_SIDED|95.0|-0.183|0.011||Mixed effect model repeat measurement (MMRM) includes terms of parameter baseline as continuous covariate, and treatment and visit as fixed factors, interaction of treatment and visit, and interaction of parameter baseline and visit.|MMRM|Within-subject covariance is unstructured.||||0.011|-0.183|0.0810
72460145|NCT02604199|144443188|SUPERIORITY||LS Mean Difference|-0.309|STANDARD_ERROR_OF_MEAN|0.048|<|0.0001|TWO_SIDED|95.0|-0.406|-0.212||MMRM includes terms of parameter baseline as continuous covariate, and treatment and visit as fixed factors, interaction of treatment and visit, and interaction of parameter baseline and visit. Within-subject covariance is unstructured.|MMRM|||||-0.212|-0.406|<.0001
72460146|NCT02604199|144443188|SUPERIORITY||LS Mean Difference|-0.223|STANDARD_ERROR_OF_MEAN|0.049|<|0.0001|TWO_SIDED|95.0|-0.322|-0.124||MMRM includes terms of parameter baseline as continuous covariate, and treatment and visit as fixed factors, interaction of treatment and visit, and interaction of parameter baseline and visit. Within-subject covariance is unstructured.|MMRM|||||-0.124|-0.322|<.0001
72460147|NCT02604199|144443189|SUPERIORITY||LS Mean|-0.089|STANDARD_ERROR_OF_MEAN|0.046||0.0583|TWO_SIDED|95.0|-0.181|0.003||MMRM includes terms of parameter baseline as continuous covariate, and treatment and visit as fixed factors, interaction of treatment and visit, and interaction of parameter baseline and visit. Within-subject covariance is unstructured.|MMRM|||Day 15||0.003|-0.181|0.0583
72460148|NCT02604199|144443189|SUPERIORITY||LS Mean|-0.176|STANDARD_ERROR_OF_MEAN|0.045||0.003|TWO_SIDED|95.0|-0.267|-0.085||MMRM includes terms of parameter baseline as continuous covariate, and treatment and visit as fixed factors, interaction of treatment and visit, and interaction of parameter baseline and visit. Within-subject covariance is unstructured.|MMRM|||Day 15||-0.085|-0.267|0.003
72460149|NCT02604199|144443189|SUPERIORITY||LS Mean|-0.087|STANDARD_ERROR_OF_MEAN|0.047||0.067|TWO_SIDED|95.0|-0.181|0.006||MMRM includes terms of parameter baseline as continuous covariate, and treatment and visit as fixed factors, interaction of treatment and visit, and interaction of parameter baseline and visit. Within-subject covariance is unstructured.|MMRM|||Day 15||0.006|-0.181|0.0670
72460150|NCT02604199|144443189|SUPERIORITY||LS Mean|-0.07|STANDARD_ERROR_OF_MEAN|0.04||0.0875|TWO_SIDED|95.0|-0.151|0.011||MMRM includes terms of parameter baseline as continuous covariate, and treatment and visit as fixed factors, interaction of treatment and visit, and interaction of parameter baseline and visit. Within-subject covariance is unstructured.|MMRM|||Day 29||0.011|-0.151|0.0875
72460151|NCT02604199|144443189|SUPERIORITY||LS Mean|-0.179|STANDARD_ERROR_OF_MEAN|0.04|<|0.0001|TWO_SIDED|95.0|-0.259|-0.1||MMRM includes terms of parameter baseline as continuous covariate, and treatment and visit as fixed factors, interaction of treatment and visit, and interaction of parameter baseline and visit. Within-subject covariance is unstructured.|MMRM|||Day 29||-0.100|-0.259|<.0001
72501135|NCT00996840|144532233|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.608|STANDARD_ERROR_OF_MEAN|0.17|||TWO_SIDED|95.0|0.433|0.853||||||Comparison at 6 h post first dose||0.853|0.433|
72460152|NCT02604199|144443189|SUPERIORITY||LS Mean|-0.109|STANDARD_ERROR_OF_MEAN|0.041||0.0099|TWO_SIDED|95.0|-0.191|-0.027||MMRM includes terms of parameter baseline as continuous covariate, and treatment and visit as fixed factors, interaction of treatment and visit, and interaction of parameter baseline and visit. Within-subject covariance is unstructured.|MMRM|||Day 29||-0.027|-0.191|0.0099
72620967|NCT00452400|144772846|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|38.232|STANDARD_ERROR_OF_MEAN|6.192|<|0.0001|TWO_SIDED|95.0|26.054|50.409|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 10 mcg qd minus Placebo|||50.409|26.054|<.0001
72620968|NCT00452400|144772846|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|25.408|STANDARD_ERROR_OF_MEAN|6.403|<|0.0001|TWO_SIDED|95.0|12.814|38.002|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 20 mcg qd minus Placebo|||38.002|12.814|<.0001
72392558|NCT02155608|144292443|SUPERIORITY|||||||0.62|||||||Mixed Models Analysis|Group: F =.25, df = 1/53.||Phase 1a: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects.||||.62
72460153|NCT02604199|144443189|SUPERIORITY||LS Mean|-0.143|STANDARD_ERROR_OF_MEAN|0.043||0.0017|TWO_SIDED|95.0|-0.229|-0.057||MMRM includes terms of parameter baseline as continuous covariate, and treatment and visit as fixed factors, interaction of treatment and visit, and interaction of parameter baseline and visit. Within-subject covariance is unstructured.|MMRM|||Day 43||-0.057|-0.229|0.0017
72460154|NCT02604199|144443189|SUPERIORITY||LS Mean|-0.265|STANDARD_ERROR_OF_MEAN|0.042|<|0.0001|TWO_SIDED|95.0|-0.349|-0.18||MMRM includes terms of parameter baseline as continuous covariate, and treatment and visit as fixed factors, interaction of treatment and visit, and interaction of parameter baseline and visit. Within-subject covariance is unstructured.|MMRM|||Day 43||-0.180|-0.349|<.0001
72501136|NCT00996840|144532233|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.674|STANDARD_ERROR_OF_MEAN|0.217|||TWO_SIDED|95.0|0.437|1.039||||||Comparison at 12 h post first dose||1.039|0.437|
72501137|NCT00996840|144532233|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.613|STANDARD_ERROR_OF_MEAN|0.247|||TWO_SIDED|95.0|0.374|1.004||||||Comparison at 18 h post first dose||1.004|0.374|
72501138|NCT00996840|144532233|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.558|STANDARD_ERROR_OF_MEAN|0.251|||TWO_SIDED|95.0|0.338|0.921||||||Comparison at 24 h post first dose||0.921|0.338|
72620969|NCT00452400|144772847|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.52|STANDARD_ERROR_OF_MEAN|0.364||0.1541|TWO_SIDED|95.0|-1.237|0.196|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 2 mcg qd minus Placebo|||0.196|-1.237|0.1541
72620970|NCT00452400|144772847|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.138|STANDARD_ERROR_OF_MEAN|0.367||0.7065|TWO_SIDED|95.0|-0.583|0.859|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 5 mcg qd minus Placebo|||0.859|-0.583|0.7065
72501139|NCT00996840|144532233|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.725|STANDARD_ERROR_OF_MEAN|0.264|||TWO_SIDED|95.0|0.427|1.23||||||Comparison at 48 h post first dose||1.230|0.427|
72501140|NCT00996840|144532233|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.73|STANDARD_ERROR_OF_MEAN|0.321|||TWO_SIDED|95.0|0.384|1.386||||||Comparison at 72 h post first dose||1.386|0.384|
72501141|NCT00996840|144532233|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|1.147|STANDARD_ERROR_OF_MEAN|0.359|||TWO_SIDED|95.0|0.559|2.353||||||Comparison at 96 h post first dose||2.353|0.559|
72501142|NCT00996840|144532233|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.776|STANDARD_ERROR_OF_MEAN|0.167|||TWO_SIDED|95.0|0.556|1.082||||||Comparison at 6 h post first dose||1.082|0.556|
72501143|NCT00996840|144532233|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.602|STANDARD_ERROR_OF_MEAN|0.212|||TWO_SIDED|95.0|0.394|0.919||||||Comparison at 12 h post first dose||0.919|0.394|
72501144|NCT00996840|144532233|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.623|STANDARD_ERROR_OF_MEAN|0.24|||TWO_SIDED|95.0|0.386|1.007||||||Comparison at 18 h post first dose||1.007|0.386|
72501145|NCT00996840|144532233|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.429|STANDARD_ERROR_OF_MEAN|0.245|||TWO_SIDED|95.0|0.263|0.7||||||Comparison at 24 h post first dose||0.700|0.263|
72460155|NCT02604199|144443189|SUPERIORITY||LS Mean|-0.122|STANDARD_ERROR_OF_MEAN|0.043||0.0072|TWO_SIDED|95.0|-0.209|-0.035||MMRM includes terms of parameter baseline as continuous covariate, and treatment and visit as fixed factors, interaction of treatment and visit, and interaction of parameter baseline and visit. Within-subject covariance is unstructured.|MMRM|||Day 43||-0.035|-0.209|0.0072
72460156|NCT02604199|144443189|SUPERIORITY||LS Mean|-0.118|STANDARD_ERROR_OF_MEAN|0.039||0.0043|TWO_SIDED|95.0|-0.197|-0.039||MMRM includes terms of parameter baseline as continuous covariate, and treatment and visit as fixed factors, interaction of treatment and visit, and interaction of parameter baseline and visit. Within-subject covariance is unstructured.|MMRM|||Day 57||-0.039|-0.197|0.0043
72501146|NCT00996840|144532233|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.502|STANDARD_ERROR_OF_MEAN|0.259|||TWO_SIDED|95.0|0.299|0.842||||||Comparison at 48 h post first dose||0.842|0.299|
72501147|NCT00996840|144532233|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.479|STANDARD_ERROR_OF_MEAN|0.317|||TWO_SIDED|95.0|0.255|0.903||||||Comparison at 72 h post first dose||0.903|0.255|
72501148|NCT00996840|144532233|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.579|STANDARD_ERROR_OF_MEAN|0.361|||TWO_SIDED|95.0|0.281|1.192||||||Comparison at 96 h post first dose||1.192|0.281|
72563325|NCT00442546|144658168|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.182|STANDARD_ERROR_OF_MEAN|0.465||0.6954||95.0|-1.101|0.736|||ANOVA||Mean difference (final values) = Least squares mean difference|40 hours||0.736|-1.101|0.6954
72563326|NCT00442546|144658168|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.081|STANDARD_ERROR_OF_MEAN|0.481||0.8665||95.0|-1.032|0.87|||ANOVA||Mean difference (final values) = Least squares mean difference|40 hours||0.870|-1.032|0.8665
72563327|NCT00442546|144658168|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.311|STANDARD_ERROR_OF_MEAN|0.386||0.4216||95.0|-0.45|1.072|||ANOVA||Mean difference (final values) = Least squares mean difference|48 hours||1.072|-0.450|0.4216
72460157|NCT02604199|144443189|SUPERIORITY||LS Mean|-0.298|STANDARD_ERROR_OF_MEAN|0.039|<|0.0001|TWO_SIDED|95.0|-0.376|-0.221||MMRM includes terms of parameter baseline as continuous covariate, and treatment and visit as fixed factors, interaction of treatment and visit, and interaction of parameter baseline and visit. Within-subject covariance is unstructured.|MMRM|||Day 57||-0.221|-0.376|< 0.0001
72501149|NCT00996840|144532234|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.484|STANDARD_ERROR_OF_MEAN|0.219|||TWO_SIDED|95.0|0.312|0.75||||||Comparison at 6 h post first dose||0.750|0.312|
72392559|NCT02155608|144292443|SUPERIORITY|||||||0.06|||||||Mixed Models Analysis|Time: F = 3.58, df = 1/53.||Phase 1a: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects.||||.06
72501150|NCT00996840|144532234|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.7|STANDARD_ERROR_OF_MEAN|0.282|||TWO_SIDED|95.0|0.399|1.229||||||Comparison at 12 h post first dose||1.229|0.399|
72501151|NCT00996840|144532234|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.681|STANDARD_ERROR_OF_MEAN|0.305|||TWO_SIDED|95.0|0.37|1.254||||||Comparison at 18 h post first dose||1.254|0.370|
72501152|NCT00996840|144532234|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.673|STANDARD_ERROR_OF_MEAN|0.302|||TWO_SIDED|95.0|0.368|1.231||||||Comparison at 24 h post first dose||1.231|0.368|
72501153|NCT00996840|144532234|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.92|STANDARD_ERROR_OF_MEAN|0.351|||TWO_SIDED|95.0|0.456|1.857||||||Comparison at 48 h post first dose||1.857|0.456|
72501154|NCT00996840|144532234|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.944|STANDARD_ERROR_OF_MEAN|0.376|||TWO_SIDED|95.0|0.445|2.002||||||Comparison at 72 h post first dose||2.002|0.445|
72501155|NCT00996840|144532234|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.905|STANDARD_ERROR_OF_MEAN|0.321|||TWO_SIDED|95.0|0.476|1.723||||||Comparison at 96 h post first dose||1.723|0.476|
72501156|NCT00996840|144532234|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.726|STANDARD_ERROR_OF_MEAN|0.199|||TWO_SIDED|95.0|0.488|1.08||||||Comparison at 6 h post first dose||1.080|0.488|
72501157|NCT00996840|144532234|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.791|STANDARD_ERROR_OF_MEAN|0.255|||TWO_SIDED|95.0|0.476|1.317||||||Comparison at 12 h post first dose||1.317|0.476|
72501158|NCT00996840|144532234|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.725|STANDARD_ERROR_OF_MEAN|0.277|||TWO_SIDED|95.0|0.417|1.26||||||Comparison at 18 h post first dose||1.260|0.417|
72501159|NCT00996840|144532234|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.655|STANDARD_ERROR_OF_MEAN|0.273|||TWO_SIDED|95.0|0.379|1.13||||||Comparison at 24 h post first dose||1.130|0.379|
72501160|NCT00996840|144532234|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|1.111|STANDARD_ERROR_OF_MEAN|0.323|||TWO_SIDED|95.0|0.583|2.12||||||Comparison at 48 h post first dose||2.120|0.583|
72563328|NCT00442546|144658168|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.285|STANDARD_ERROR_OF_MEAN|0.391||0.4673||95.0|-0.487|1.056|||ANOVA||Mean difference (final values) = Least squares mean difference|48 hours||1.056|-0.487|0.4673
72563329|NCT00442546|144658168|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.255|STANDARD_ERROR_OF_MEAN|0.44||0.5624||95.0|-0.614|1.125|||ANOVA||Mean difference (final values) = Least squares mean difference|56 hours||1.125|-0.614|0.5624
72563330|NCT00442546|144658168|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.402|STANDARD_ERROR_OF_MEAN|0.448||0.3705||95.0|-1.286|0.482|||ANOVA||Mean difference (final values) = Least squares mean difference|56 hours||0.482|-1.286|0.3705
72392560|NCT02155608|144292443|SUPERIORITY|||||||0.09||||||p \< .05 for statistical significance.|Mixed Models Analysis|Group \* time: F = 2.90, df 1/53.||Phase 1a: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects.||||.09
72392561|NCT02155608|144292443|SUPERIORITY|||||||0.06||||||p \< .05 for statistical significance|Mixed Models Analysis|Group: F = 3.36, df = 1/58.||Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5.||||.06
72460158|NCT02604199|144443189|SUPERIORITY||LS Mean|-0.181|STANDARD_ERROR_OF_MEAN|0.04|<|0.0001|TWO_SIDED|95.0|-0.261|-0.1||MMRM includes terms of parameter baseline as continuous covariate, and treatment and visit as fixed factors, interaction of treatment and visit, and interaction of parameter baseline and visit. Within-subject covariance is unstructured.|MMRM|||Day 57||-0.100|-0.261|<.0001
72501161|NCT00996840|144532234|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|1.075|STANDARD_ERROR_OF_MEAN|0.346|||TWO_SIDED|95.0|0.539|2.146||||||Comparison at 72 h post first dose||2.146|0.539|
72392562|NCT02155608|144292443|SUPERIORITY|||||||0.05||||||p \< .05 for statistical significance.|Mixed Models Analysis|Time: F = 4.20, df = 1/31.||Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5.||||.05
72392563|NCT02155608|144292443|SUPERIORITY|||||||0.42||||||p \< .05 for statistical significance.|Mixed Models Analysis|Group \* time: F = .66, df = 1/31.||Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5.||||.42
72460159|NCT02604199|144443189|SUPERIORITY||LS Mean|-0.132|STANDARD_ERROR_OF_MEAN|0.048||0.0084|TWO_SIDED|95.0|-0.228|-0.035||MMRM includes terms of parameter baseline as continuous covariate, and treatment and visit as fixed factors, interaction of treatment and visit, and interaction of parameter baseline and visit. Within-subject covariance is unstructured.|MMRM|||Day 71||-0.035|-0.228|0.0084
72460160|NCT02604199|144443189|SUPERIORITY||LS Mean|-0.338|STANDARD_ERROR_OF_MEAN|0.047|<|0.0001|TWO_SIDED|95.0|-0.433|-0.243||MMRM includes terms of parameter baseline as continuous covariate, and treatment and visit as fixed factors, interaction of treatment and visit, and interaction of parameter baseline and visit. Within-subject covariance is unstructured.|MMRM|||Day 71||-0.243|-0.433|<.0001
72460161|NCT02604199|144443189|SUPERIORITY||LS Mean|-0.206|STANDARD_ERROR_OF_MEAN|0.049||0.0001|TWO_SIDED|95.0|-0.304|-0.108||MMRM includes terms of parameter baseline as continuous covariate, and treatment and visit as fixed factors, interaction of treatment and visit, and interaction of parameter baseline and visit. Within-subject covariance is unstructured.|MMRM|||Day 71||-0.108|-0.304|0.0001
72460162|NCT02604199|144443189|SUPERIORITY||LS Mean|-0.096|STANDARD_ERROR_OF_MEAN|0.05||0.0589|TWO_SIDED|95.0|-0.195|0.004||MMRM includes terms of parameter baseline as continuous covariate, and treatment and visit as fixed factors, interaction of treatment and visit, and interaction of parameter baseline and visit. Within-subject covariance is unstructured.|MMRM|||Day 85||0.004|-0.195|0.0589
72460163|NCT02604199|144443189|SUPERIORITY||LS Mean|-0.335|STANDARD_ERROR_OF_MEAN|0.049|<|0.0001|TWO_SIDED|95.0|-0.433|-0.236||MMRM includes terms of parameter baseline as continuous covariate, and treatment and visit as fixed factors, interaction of treatment and visit, and interaction of parameter baseline and visit. Within-subject covariance is unstructured.|MMRM|||Day 85||-0.236|-0.433|<.0001
72460164|NCT02604199|144443189|SUPERIORITY||LS Mean|-0.239|STANDARD_ERROR_OF_MEAN|0.05|<|0.0001|TWO_SIDED|95.0|-0.34|-0.137||MMRM includes terms of parameter baseline as continuous covariate, and treatment and visit as fixed factors, interaction of treatment and visit, and interaction of parameter baseline and visit. Within-subject covariance is unstructured.|MMRM|||Day 85||-0.137|-0.340|<.0001
72392564|NCT02155608|144292444|SUPERIORITY|||||||0.29||||||p \< .05 for statistical significance.|Mixed Models Analysis|Group: F = 0.29, df = 1/129.||Phase 1a: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects.||||.29
72460165|NCT02604199|144443189|SUPERIORITY||LS Mean|-0.132|STANDARD_ERROR_OF_MEAN|0.052||0.0138|TWO_SIDED|95.0|-0.236|-0.028||MMRM includes terms of parameter baseline as continuous covariate, and treatment and visit as fixed factors, interaction of treatment and visit, and interaction of parameter baseline and visit. Within-subject covariance is unstructured.|MMRM|||Day 99||-0.028|-0.236|0.0138
72501162|NCT00996840|144532234|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|1.375|STANDARD_ERROR_OF_MEAN|0.313|||TWO_SIDED|95.0|0.735|2.574||||||Comparison at 96 h post first dose||2.574|0.735|
72501163|NCT00996840|144532234|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.559|STANDARD_ERROR_OF_MEAN|0.168|||TWO_SIDED|95.0|0.4|0.783||||||Comparison at 6 h post first dose||0.783|0.400|
72501164|NCT00996840|144532234|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.83|STANDARD_ERROR_OF_MEAN|0.216|||TWO_SIDED|95.0|0.539|1.277||||||Comparison at 12 h post first dose||1.277|0.539|
72501165|NCT00996840|144532234|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.987|STANDARD_ERROR_OF_MEAN|0.238|||TWO_SIDED|95.0|0.613|1.589||||||Comparison at 18 h post first dose||1.589|0.613|
72501166|NCT00996840|144532234|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.924|STANDARD_ERROR_OF_MEAN|0.231|||TWO_SIDED|95.0|0.582|1.467||||||Comparison at 24 h post first dose||1.467|0.582|
72501167|NCT00996840|144532234|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|1.23|STANDARD_ERROR_OF_MEAN|0.27|||TWO_SIDED|95.0|0.716|2.11||||||Comparison at 48 h post first dose||2.110|0.716|
72501168|NCT00996840|144532234|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|1.289|STANDARD_ERROR_OF_MEAN|0.292|||TWO_SIDED|95.0|0.719|2.312||||||Comparison at 72 h post first dose||2.312|0.719|
72501169|NCT00996840|144532234|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|1.752|STANDARD_ERROR_OF_MEAN|0.254|||TWO_SIDED|95.0|1.053|2.916||||||Comparison at 96 h post first dose||2.916|1.053|
72501170|NCT00996840|144532234|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.58|STANDARD_ERROR_OF_MEAN|0.163|||TWO_SIDED|95.0|0.419|0.803||||||Comparison at 6 h post first dose||0.803|0.419|
72392565|NCT02155608|144292444|SUPERIORITY|||||||0.02||||||p \< .05 for statistical significance.|Mixed Models Analysis|Time: F = 5.83, df = 1/129.||Phase 1a: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects.||||.02
72392566|NCT02155608|144292444|SUPERIORITY|||||||0.31||||||p \< .05 for statistical significance.|Mixed Models Analysis|Group \* time: F = 1.03, df = 1/129.||Phase 1a: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects.||||.31
72460166|NCT02604199|144443189|SUPERIORITY||LS Mean|-0.355|STANDARD_ERROR_OF_MEAN|0.051|<|0.0001|TWO_SIDED|95.0|-0.458|-0.252||MMRM includes terms of parameter baseline as continuous covariate, and treatment and visit as fixed factors, interaction of treatment and visit, and interaction of parameter baseline and visit. Within-subject covariance is unstructured.|MMRM|||Day 99||-0.252|-0.458|<.0001
72460167|NCT02604199|144443189|SUPERIORITY||LS Mean|-0.223|STANDARD_ERROR_OF_MEAN|0.053||0.0001|TWO_SIDED|95.0|-0.329|-0.117||MMRM includes terms of parameter baseline as continuous covariate, and treatment and visit as fixed factors, interaction of treatment and visit, and interaction of parameter baseline and visit. Within-subject covariance is unstructured.|MMRM|||Day 99||-0.117|-0.329|0.0001
72460168|NCT01426217|144443272|OTHER|Efficacy|Odds Ratio (OR)|0.79|||||TWO_SIDED|95.0|0.63|0.98||||||||0.98|0.63|
72460169|NCT01426217|144443273|OTHER|Efficacy|Odds Ratio (OR)|0.91|||||TWO_SIDED|95.0|0.62|1.35||||||||1.35|0.62|
72460170|NCT02991456|144443342|OTHER|||||||0.2734|||||||Chi-squared|||||||0.2734
72460171|NCT02991456|144443343|OTHER|||||||0.7091|||||||Chi-squared|||||||0.7091
72460172|NCT02991456|144443344|EQUIVALENCE|This was tested as patients who preferred rolapitant + ondansetron vs. patients who did not prefer rolapitant + ondansetron. Patients who reported no preference and preference to Ondansetron were combined.||||||0.0004|||||||Exact Binomial|||||||0.0004
72460173|NCT02991456|144443344|EQUIVALENCE|Three outcomes tested by sequence.||||||0.5207|||||||Fisher Exact|||||||0.5207
72460174|NCT02991456|144443345|EQUIVALENCE|Effectiveness during weeks 1-3 between sequences.||||||0.0406|||||||t-test, 1 sided|T-test using the Satterthwaite method for unequal variances.||||||0.0406
72460175|NCT02991456|144443346|EQUIVALENCE|Convenience during weeks 1-3 between sequences.||||||0.0541|||||||t-test, 1 sided|T-test using the pooled method for equal variances.||||||0.0541
72563331|NCT00442546|144658168|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.358|STANDARD_ERROR_OF_MEAN|0.476||0.4539||95.0|-1.302|0.586|||ANOVA||Mean difference (final values) = Least squares mean difference|64 hours||0.586|-1.302|0.4539
72460176|NCT02991456|144443347|EQUIVALENCE|Overall satisfaction during weeks 1-3 between sequences.||||||0.0781|||||||t-test, 1 sided|T-test using the pooled method for equal variances.||||||0.0781
72460177|NCT02991456|144443348|EQUIVALENCE|Effectiveness during weeks 4-6 between sequences.||||||0.4146|||||||t-test, 1 sided|T-test using the pooled method for equal variances.||||||0.4146
72460178|NCT02991456|144443349|EQUIVALENCE|Convenience during weeks 4-6 between sequences.||||||0.2214|||||||t-test, 1 sided|T-test using the pooled method for equal variances.||||||0.2214
72460179|NCT02991456|144443350|EQUIVALENCE|Overall satisfaction during weeks 4-6 between sequences.||||||0.2028|||||||t-test, 1 sided|T-test using the Satterthwaite method for unequal variances.||||||0.2028
72460180|NCT00738400|144443362|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.76|||<|0.0001||95.0|-9.03|-4.49|||ANCOVA|||ANCOVA, baseline covariate, endpoint week 8 or LOCF. Factors: treatment, pooled centers. Ls mean at endpoint||-4.49|-9.03|<0.0001
72460181|NCT00738400|144443363|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-20.71|||<|0.0001||95.0|-30.66|-10.76|||ANCOVA|||ANCOVA, baseline covariate, endpoint week 8 or LOCF. Factors: treatment, pooled centers. Ls mean at endpoint||-10.76|-30.66|<0.0001
72460182|NCT00738400|144443364|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-26.16|||<|0.0001||95.0|-37.48|-14.83|||ANCOVA|||ANCOVA, baseline covariate, endpoint week 8 or LOCF. Factors: treatment, pooled centers. Ls mean at endpoint||-14.83|-37.48|<0.0001
72460183|NCT00738400|144443365|SUPERIORITY_OR_OTHER|||||||0.0004|||||||Mantel Haenszel|||Mantel-Haenszel Test||||0.0004
72460184|NCT00738400|144443366|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.57||||0.0003||95.0|-23.8|-7.34|||ANCOVA|||ANCOVA, baseline covariate, endpoint week 8 or LOCF. Factors: treatment, pooled centers. Ls mean at endpoint||-7.34|-23.80|0.0003
72460185|NCT00738400|144443367|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-27.33|||<|0.0001||95.0|-37.24|-17.43|||ANCOVA|||ANCOVA, baseline covariate, endpoint week 8 or LOCF. Factors: treatment, pooled centers. Ls mean at endpoint||-17.43|-37.24|<0.0001
72460186|NCT05381948|144443394|OTHER||Least Square (LS) Mean|-0.12|STANDARD_ERROR_OF_MEAN|1.199||0.919|TWO_SIDED|95.0|-2.48|2.24|||Mixed Model for Repeated Measures (MMRM)|||||2.24|-2.48|0.919
72460187|NCT05381948|144443394|OTHER||LS Mean|-0.31|STANDARD_ERROR_OF_MEAN|1.187||0.795|TWO_SIDED|95.0|-2.63|2.02|||MMRM|||||2.02|-2.63|0.795
72460188|NCT04198428|144443408|SUPERIORITY||Odds Ratio (OR)|1.49|||<|0.05|TWO_SIDED||||||Mixed Models Analysis|Mixed-model regression adjusted for site and clinic factors balanced at randomization||||||<0.05
72460189|NCT04198428|144443409|SUPERIORITY||Odds Ratio (OR)|1.76|||<|0.05|TWO_SIDED||||||Mixed Models Analysis|Mixed-model regression adjusted for site and clinic factors balanced at randomization||||||<0.05
72460190|NCT04198428|144443410|SUPERIORITY||Odds Ratio (OR)|1.43|||<|0.05|TWO_SIDED||||||Mixed Models Analysis|Mixed-model regression adjusted for site and clinic factors balanced at randomization||||||<0.05
72563332|NCT00442546|144658168|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.086|STANDARD_ERROR_OF_MEAN|0.515||0.0373||95.0|-2.107|-0.065|||ANOVA||Mean difference (final values) = Least squares mean difference|64 hours||-0.065|-2.107|0.0373
72460191|NCT04198428|144443411|SUPERIORITY||Risk Ratio (RR)|0.99|||<|0.05|TWO_SIDED||||||Mixed Models Analysis|Zero-inflated negative binomial mixed-model regression adjusted for site and clinic factors balanced at randomization||||||<0.05
72460192|NCT04198428|144443412|SUPERIORITY||Risk Ratio (RR)|0.93|||<|0.05|TWO_SIDED||||||Mixed Models Analysis|Generalized estimating equation comparing post- to pre-index rates in OUD-CDS vs. Usual Care, adjusted for site and balancing factors||||||<0.05
72460193|NCT04198428|144443413|SUPERIORITY||Risk Ratio (RR)|1.01|||<|0.05|TWO_SIDED||||||Mixed Models Analysis|Generalized estimating equation comparing post- to pre-index rates in OUD-CDS vs. Usual Care, adjusted for site and balancing factors||||||<0.05
72460194|NCT04198428|144443414|SUPERIORITY||Mean Difference (Net)|-1068.0|||<|0.05|TWO_SIDED||||||Mixed Models Analysis||Generalized estimating equation comparing post- to pre-index costs in OUD-CDS vs. Usual Care, adjusted for site and balancing factors|||||<0.05
72460195|NCT04198428|144443415|SUPERIORITY||Odds Ratio (OR)|1.06|||<|0.05|TWO_SIDED||||||Mixed Models Analysis|||||||<0.05
72460196|NCT04198428|144443416|SUPERIORITY||Risk Ratio (RR)|1.08|||<|0.05|TWO_SIDED||||||Mixed Models Analysis||Generalized estimating equation comparing post- to pre-index rates in OUD-CDS vs. Usual Care, adjusted for site and balancing factors|||||<0.05
72563333|NCT00442546|144658168|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.146|STANDARD_ERROR_OF_MEAN|0.476||0.76||95.0|-0.796|1.087|||ANOVA||Mean difference (final values) = Least squares mean difference|72 hours||1.087|-0.796|0.7600
72460197|NCT04396860|144443417|SUPERIORITY||Hazard Ratio (HR)|1.47||||0.96|TWO_SIDED|95.0|0.98|2.21|||Log Rank|Stratified log-rank|Reference level = Arm 1|For the phase II endpoint, observation of 100 PFS events among the 150 randomized patients (from both arms) provides 95% statistical power to detect an improvement in median PFS from 5.7 months in the control arm to 9.7 months in the experimental arm, corresponding to a hazard reduction of 42% (hazard ratio 0.58) at one-sided significance level of 0.15 (and 87% power for hazard ratio of 0.65 at this same alpha).||2.21|0.98|0.96
72392567|NCT02155608|144292444|SUPERIORITY|||||||0.69||||||p \< .05 for statistical significance.|Mixed Models Analysis|Group: F = .16, df = 1/59.||Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5.||||.69
72501171|NCT00996840|144532234|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.657|STANDARD_ERROR_OF_MEAN|0.209|||TWO_SIDED|95.0|0.433|0.996||||||Comparison at 12 h post first dose||0.996|0.433|
72563334|NCT00442546|144658168|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.555|STANDARD_ERROR_OF_MEAN|0.481||0.2506||95.0|-1.507|0.397|||ANOVA||Mean difference (final values) = Least squares mean difference|72 hours||0.397|-1.507|0.2506
72563335|NCT00442546|144658168|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.027|STANDARD_ERROR_OF_MEAN|0.895||0.2567||95.0|-0.77|2.823|||ANOVA||Mean difference (final values) = Least squares mean difference|80 hours||2.823|-0.770|0.2567
72563336|NCT00442546|144658168|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.882|STANDARD_DEVIATION|0.76||0.0167||95.0|-3.408|-0.356|||ANOVA||Mean difference (final values) = Least squares mean difference|80 hours||-0.356|-3.408|0.0167
72460198|NCT04649359|144443435|OTHER||||||<|0.0001|||||||Exact binominal|||Null hypothesis of ORR by BICR for cohort A was 30%.||||<0.0001
72460199|NCT04649359|144443435|OTHER||||||<|0.0001|||||||Exact binominal|||Null hypothesis of ORR by BICR for cohort B was 15%.||||<0.0001
72460200|NCT04649359|144443436|OTHER||||||<|0.0001|||||||Exact binominal|||Null hypothesis of ORR by BICR for cohort A was 12%.||||<0.0001
72460201|NCT04649359|144443437|OTHER||||||<|0.0001|||||||Exact binominal|||Null hypothesis of ORR by BICR for cohort A was 38%.||||<0.0001
72460202|NCT02282761|144443490|SUPERIORITY||Least Squares Mean Difference|-2.6|STANDARD_ERROR_OF_MEAN|1.83||0.182|TWO_SIDED|95.0|-6.17|1.05|||Mixed Effects Model for Repeated Measure|||||1.05|-6.17|0.182
72460203|NCT02282761|144443490|SUPERIORITY||Least Squares Mean Difference|-4.2|STANDARD_ERROR_OF_MEAN|1.82||0.045|TWO_SIDED|95.0|-7.75|-0.6|||Mixed Effects Model for Repeated Measure|||||-0.60|-7.75|0.045
72460204|NCT02282761|144443491|SUPERIORITY||Least Squares Mean Difference|-0.3||||0.045|TWO_SIDED|95.0|-0.54|-0.12|||Mixed Effects Model for Repeated Measure|||||-0.12|-0.54|0.045
72460205|NCT01842360|144443546|SUPERIORITY||||||<|0.01|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.01
72460206|NCT01842360|144443547|SUPERIORITY||||||<|0.001|TWO_SIDED|95.0|||||Poisson|||||||<0.001
72460207|NCT01842360|144443548|SUPERIORITY|||||||0.0094|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||The mean of health care consumption was 17.5±34.7 points in the placebo group versus 9.2±27.9 points in the MV130 group.||||0.0094
72460208|NCT01842360|144443549|SUPERIORITY|||||||0.3917|TWO_SIDED|95.0|||||Log Rank|||||||0.3917
72460209|NCT01842360|144443550|SUPERIORITY|||||||0.0232|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||As for the previous index the number of days with any of these drugs is used.||||0.0232
72460210|NCT01842360|144443551|SUPERIORITY|||||||0.0319|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0319
72460211|NCT01842360|144443552|SUPERIORITY|||||||0.0264|||||||Wilcoxon (Mann-Whitney)|||||||0.0264
72460212|NCT01842360|144443553|SUPERIORITY|||||||0.0037|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||The mean number of emergency room visits was 0.37 (±1.15) for the MV130 group and 0.87 (±1.61) for the placebo group.||||0.0037
72460213|NCT01842360|144443554|SUPERIORITY|||||||0.1008|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||The mean number of medical consultations was 0.08 (±0.31) for the MV130 group and 0.31 (±0.88) for the placebo group.||||0.1008
72460214|NCT01842360|144443555|SUPERIORITY|||||||0.0367|TWO_SIDED|95.0|||||t-test, 2 sided|||||||0.0367
72460215|NCT01842360|144443557|SUPERIORITY|||||||0.3234|TWO_SIDED|95.0|||||Fisher Exact|||||||0.3234
72460216|NCT01842360|144443558|SUPERIORITY|||||||0.001|||||||Log Rank|||||||0.001
72460217|NCT04551053|144443560|SUPERIORITY|p-value for superiority is half of the CMH p-value.|Odds Ratio (OR)|1.8||||0.2567|TWO_SIDED|95.0|0.65|5.02||CMH test for un-equality stratified by Dynamic International Prognostic Scoring System (DIPSS) category (intermediate 1 versus intermediate 2 and high) and Baseline platelet count (≥100 × 10\^9/Liters \[L\] versus 50 to \<100 × 10\^9/L inclusive)|Cochran-Mantel-Haenszel|||||5.02|0.65|0.2567
72501172|NCT00996840|144532234|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.747|STANDARD_ERROR_OF_MEAN|0.225|||TWO_SIDED|95.0|0.477|1.171||||||Comparison at 18 h post first dose||1.171|0.477|
72501173|NCT00996840|144532234|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.657|STANDARD_ERROR_OF_MEAN|0.222|||TWO_SIDED|95.0|0.421|1.024||||||Comparison at 24 h post first dose||1.024|0.421|
72501174|NCT00996840|144532234|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.759|STANDARD_ERROR_OF_MEAN|0.261|||TWO_SIDED|95.0|0.451|1.279||||||Comparison at 48 h post first dose||1.279|0.451|
72501175|NCT00996840|144532234|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.968|STANDARD_ERROR_OF_MEAN|0.282|||TWO_SIDED|95.0|0.55|1.701||||||Comparison at 72 h post first dose||1.701|0.550|
72501176|NCT00996840|144532234|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.744|STANDARD_ERROR_OF_MEAN|0.251|||TWO_SIDED|95.0|0.45|1.229||||||Comparison at 96 h post first dose||1.229|0.450|
72563337|NCT00442546|144658168|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.352|STANDARD_ERROR_OF_MEAN|0.89||0.6953||95.0|-1.456|2.159|||ANOVA||Mean difference (final values) = Least squares mean difference|88 hours||2.159|-1.456|0.6953
72620971|NCT00452400|144772847|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.964|STANDARD_ERROR_OF_MEAN|0.359||0.0076|TWO_SIDED|95.0|-1.671|-0.258|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 10 mcg qd minus Placebo|||-0.258|-1.671|0.0076
72620972|NCT00452400|144772847|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.414|STANDARD_ERROR_OF_MEAN|0.369||0.2626|TWO_SIDED|95.0|-1.138|0.311|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 20 mcg qd minus Placebo|||0.311|-1.138|0.2626
72563338|NCT00442546|144658168|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.147|STANDARD_ERROR_OF_MEAN|0.894||0.208||95.0|-2.962|0.668|||ANOVA||Mean difference (final values) = Least squares mean difference|88 hours||0.668|-2.962|0.2080
72460218|NCT04551053|144443561|SUPERIORITY|p-value for superiority is half of the CMH p-value.|Odds Ratio (OR)|1.34||||0.5349|TWO_SIDED|95.0|0.53|3.39||calculated from Cochran Mantel-Haenszel test for un-equality stratified by DIPSS category (intermediate 1 versus intermediate 2 and high) and Baseline platelet count (≥100 × 10\^9/L versus 50 to \<100 × 10\^9/L inclusive)|Cochran-Mantel-Haenszel|||||3.39|0.53|0.5349
72460219|NCT04551053|144443563|SUPERIORITY|||||||0.2224||||||calculated from log-rank test stratified by DIPSS category (intermediate 1 versus intermediate 2 and high) and Baseline platelet count (≥100 x 10\^9/L versus 50 to \<100 x 10\^9/L inclusive)|Log Rank|||||||0.2224
72460220|NCT04016415|144443574|SUPERIORITY|Two-sided tests with the null hypothesis of no difference in chg from Baseline to 6MO between the two arms. The power calculation assumed a clinically meaningful diff of 0.5% and standard deviation of 0.9%. Assuming an avg class cohort size of 18 pts and an intraclass correlation coefficient estimate of 0.08 for correlation within cohorts yielded a design effect that inflated the sample size by 1+((18-1) multiplied by 0.08)=2.36. A 15% dropout rate was assumed. 145 pts per arm yielded 80% power.|Mean Difference (Net)|-0.01||||0.96|TWO_SIDED|95.0|-0.36|0.34||A priori significance level = 0.05; two-sided. Analyses were based upon pre-specified hypotheses, and therefore corrections for multiple testing were not made.|Mixed Models Analysis|Linear; Fixed: arm+visit\[base,2MO,6MO\]+insulin at base+(armXvisit interact); Random: subjects, cohort(arm); Residual: longitudinal repeated measures|Change = 6MO - Baseline; Difference = SME - MBSR; Contrasts were constructed from the linear mixed model to estimate the changes.|||0.34|-0.36|0.96
72460221|NCT04016415|144443575|SUPERIORITY|All hypothesis tests are two-sided (any difference), with the null hypothesis of no difference in change from Baseline to 2MO between the two arms.|Mean Difference (Net)|-0.07||||0.68|TWO_SIDED|95.0|-0.38|0.25||A priori significance level = 0.05; two-sided. Analyses were based upon pre-specified hypotheses, and therefore corrections for multiple testing were not made.|Mixed Models Analysis|Linear; Fixed: arm+visit\[base,2MO,6MO\]+insulin at base+(armXvisit interact); Random: subjects, cohort(arm); Residual: longitudinal repeated measures|Change = 2MO - Baseline; Difference = SME - MBSR; Contrasts were constructed from the linear mixed model to estimate the changes.|||0.25|-0.38|0.68
72460222|NCT04016415|144443576|SUPERIORITY|All hypothesis tests are two-sided (any difference), with the null hypothesis of no difference in change from Baseline to 2MO between the two arms.|Mean Difference (Net)|0.06||||0.41|TWO_SIDED|95.0|-0.09|0.21||A priori significance level = 0.05; two-sided. Analyses were based upon pre-specified hypotheses, and therefore corrections for multiple testing were not made.|Mixed Models Analysis|Linear; Fixed: arm+visit\[base,2MO,6MO\]+insulin at base+(armXvisit interact); Random: subjects, cohort(arm); Residual: longitudinal repeated measures|Change = 2MO - Baseline; Difference = SME - MBSR; Contrasts were constructed from the linear mixed model to estimate the changes.|||0.21|-0.09|0.41
72501177|NCT00996840|144532235|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.773|STANDARD_ERROR_OF_MEAN|0.121|||TWO_SIDED|95.0|0.607|0.985||||||Comparison at 6 h post first dose||0.985|0.607|
72501178|NCT00996840|144532235|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.795|STANDARD_ERROR_OF_MEAN|0.155|||TWO_SIDED|95.0|0.583|1.084||||||Comparison at 12 h post first dose||1.084|0.583|
72501179|NCT00996840|144532235|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.778|STANDARD_ERROR_OF_MEAN|0.189|||TWO_SIDED|95.0|0.533|1.135||||||Comparison at 18 h post first dose||1.135|0.533|
72501180|NCT00996840|144532235|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.633|STANDARD_ERROR_OF_MEAN|0.193|||TWO_SIDED|95.0|0.43|0.931||||||Comparison at 24 h post first dose||0.931|0.430|
72563339|NCT00442546|144658168|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.867|STANDARD_ERROR_OF_MEAN|0.975||0.3805||95.0|-1.116|2.849|||ANOVA||Mean difference (final values) = Least squares mean difference|96 hours||2.849|-1.116|0.3805
72370545|NCT00488683|144251633|SUPERIORITY_OR_OTHER||R-square|0.05||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between memory B cells one month after primary vaccination and memory B cells rise from pre-booster to one month after booster vaccination for the serogroup C||||
72460223|NCT04016415|144443577|SUPERIORITY|All hypothesis tests are two-sided (any difference), with the null hypothesis of no difference in change from Baseline to 6MO between the two arms.|Mean Difference (Net)|-0.05||||0.59|TWO_SIDED|95.0|-0.22|0.12||A priori significance level = 0.05; two-sided. Analyses were based upon pre-specified hypotheses, and therefore corrections for multiple testing were not made.|Mixed Models Analysis|Linear; Fixed: arm+visit\[base,2MO,6MO\]+insulin at base+(armXvisit interact); Random: subjects, cohort(arm); Residual: longitudinal repeated measures|Change = 6MO - Baseline; Difference = SME - MBSR; Contrasts were constructed from the linear mixed model to estimate the changes.|||0.12|-0.22|0.59
72501181|NCT00996840|144532235|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.662|STANDARD_ERROR_OF_MEAN|0.255|||TWO_SIDED|95.0|0.397|1.103||||||Comparison at 48 h post first dose||1.103|0.397|
72501182|NCT00996840|144532235|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.465|STANDARD_ERROR_OF_MEAN|0.243|||TWO_SIDED|95.0|0.286|0.756||||||Comparison at 72 h post first dose||0.756|0.286|
72501183|NCT00996840|144532235|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.525|STANDARD_ERROR_OF_MEAN|0.287|||TWO_SIDED|95.0|0.295|0.935||||||Comparison at 96 h post first dose||0.935|0.295|
72501184|NCT00996840|144532235|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.952|STANDARD_ERROR_OF_MEAN|0.107|||TWO_SIDED|95.0|0.768|1.18||||||Comparison at 6 h post first dose||1.180|0.768|
72563340|NCT00442546|144658168|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.126|STANDARD_ERROR_OF_MEAN|0.905||0.89||95.0|-1.965|1.713|||ANOVA||Mean difference (final values) = Least squares mean difference|96 hours||1.713|-1.965|0.8900
72563341|NCT00442546|144658168|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.672|STANDARD_ERROR_OF_MEAN|1.08||0.1821||95.0|-1.103|4.448|||ANOVA||Mean difference (final values) = Least squares mean difference|104 hours||4.448|-1.103|0.1821
72563342|NCT00442546|144658168|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.851|STANDARD_ERROR_OF_MEAN|1.768||0.6505||95.0|-3.693|5.395|||ANOVA||Mean difference (final values) = Least squares mean difference|104 hours||5.395|-3.693|0.6505
72370546|NCT00488683|144251633|SUPERIORITY_OR_OTHER||R-square|0.19||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and memory B cells rise from pre-booster to one month after booster vaccination for the serogroup W-135||||
72370547|NCT00488683|144251633|SUPERIORITY_OR_OTHER||R-square|0.03||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between memory B cells one month after primary vaccination and memory B cells rise from pre-booster to one month after booster vaccination for the serogroup W-135||||
72460224|NCT04016415|144443578|SUPERIORITY|All hypothesis tests are two-sided (any difference), with the null hypothesis of no difference in change from Baseline to 2MO between the two arms.|Mean Difference (Net)|1.57||||0.04|TWO_SIDED|95.0|0.07|3.06||A priori significance level = 0.05; two-sided. Analyses were based upon pre-specified hypotheses, and therefore corrections for multiple testing were not made.|Mixed Models Analysis|Linear; Fixed: arm+visit\[base,2MO,6MO\]+insulin at base+(armXvisit interact); Random: subjects, cohort(arm); Residual: longitudinal repeated measures|Change = 2MO - Baseline; Difference = SME - MBSR; Contrasts were constructed from the linear mixed model to estimate the changes.|||3.06|0.07|0.04
72460225|NCT04016415|144443579|SUPERIORITY|All hypothesis tests are two-sided (any difference), with the null hypothesis of no difference in change from Baseline to 6MO between the two arms.|Mean Difference (Net)|0.83||||0.3|TWO_SIDED|95.0|-0.74|2.4||A priori significance level = 0.05; two-sided. Analyses were based upon pre-specified hypotheses, and therefore corrections for multiple testing were not made.|Mixed Models Analysis|Linear; Fixed: arm+visit\[base,2MO,6MO\]+insulin at base+(armXvisit interact); Random: subjects, cohort(arm); Residual: longitudinal repeated measures|Change = 6MO - Baseline; Difference = SME - MBSR; Contrasts were constructed from the linear mixed model to estimate the changes.|||2.40|-0.74|0.30
72460226|NCT05615870|144443622|SUPERIORITY||Mean Difference (Final Values)|5.41||||0.537|TWO_SIDED|95.0|-11.77|22.6|||Mixed Models Analysis|||Null hypothesis: mean of SFDs in the HEPA filtration home intervention group will not differ from the mean of SFDs in the control group||22.60|-11.77|0.537
72460227|NCT05615870|144443623|SUPERIORITY||Mean Difference (Final Values)|0.12||||0.205|TWO_SIDED|95.0|-0.07|0.3|||Mixed Models Analysis|||Null hypothesis: mean of counts of hospitalizations for respiratory symptoms in the intervention group will not differ from the mean of counts of hospitalizations for respiratory symptoms in the control group||0.30|-0.07|0.205
72460228|NCT05615870|144443623|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.992|TWO_SIDED|95.0|-0.35|0.35|||Mixed Models Analysis|||Null hypothesis: mean of counts of emergency department or urgent care visits for respiratory symptoms in the intervention group will not differ from the mean of counts of emergency department or urgent care visits for respiratory symptoms in the control group||0.35|-0.35|0.992
72460229|NCT05615870|144443623|SUPERIORITY||Mean Difference (Final Values)|-0.37||||0.172|TWO_SIDED|95.0|-0.9|0.16|||Mixed Models Analysis|||Null hypothesis: mean of counts of other unscheduled healthcare visits for respiratory symptoms in the intervention group will not differ from the mean of counts of other unscheduled healthcare visits for respiratory symptoms in the control group||0.16|-0.90|0.172
72460230|NCT05615870|144443623|SUPERIORITY||Mean Difference (Final Values)|-0.25||||0.53|TWO_SIDED|95.0|-1.02|0.52|||Mixed Models Analysis|||Null hypothesis: mean of counts (or total counts) of visits of all metrics for respiratory symptoms in the intervention group will not differ from the mean of counts of visits of all metrics for respiratory symptoms in the control group||0.52|-1.02|0.530
72460231|NCT05615870|144443624|SUPERIORITY||Mean Difference (Final Values)|-0.8||||0.598|TWO_SIDED|95.0|-3.75|2.16|||Mixed Models Analysis|||Null hypothesis: mean of the Child QOL score in the HEPA intervention group will not differ from the mean of Child QOL score in the control group||2.16|-3.75|0.598
72460232|NCT05615870|144443625|SUPERIORITY||Mean Difference (Final Values)|-7.2|||<|0.001|TWO_SIDED|95.0|-10.98|-3.42|||Mixed Models Analysis||The results were based on the average PM2.5 level of common room and sleep space.|Null hypothesis: the mean of the PM2.5 level of the common room and sleep space in the intervention group will not differ from the mean of the PM2.5 level in the control group||-3.42|-10.98|<0.001
72563343|NCT00442546|144658169|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.029|STANDARD_ERROR_OF_MEAN|0.495||0.0388||95.0|-2.004|-0.053|||ANOVA||Mean difference (final values) = Least squares mean difference|24 hours||-0.053|-2.004|0.0388
72460233|NCT01885559|144443628|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.08||||0.58|TWO_SIDED|95.0|0.82|1.42|||Regression, Cox|Analyses were adjusted for age, sex, race, baseline estimated Glomerular Filtration Rate (eGFR) and clinical site|ACE+ARB (Lisinopril-telmisartan) compared to ACE+placebo (Lisinopril-placebo)|||1.42|0.82|0.58
72460234|NCT01885559|144443629|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.2||||0.88|TWO_SIDED|95.0|-3.2|2.8|||shared parameter model|shared parameter models used due to informative censoring that occurred when patients did not have secondary outcomes measured after reaching endpoint||||2.8|-3.2|0.88
72460235|NCT01885559|144443630|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.7||||0.17|TWO_SIDED|95.0|-3.9|0.7||controlling for age, sex, race, and clinical site|Mixed Models Analysis||ACE-I+ARB annual percent change minus ACE-I + placebo annual percent change|||0.7|-3.9|0.17
72460236|NCT01885559|144443631|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.03||||0.85|TWO_SIDED|95.0|0.8|1.32|||Regression, Cox|adjusting for age, sex, race, and clinical site and recurrent events|Hazard ratio compares ACE-I + ARB compared to ACE-I + placebo|||1.32|0.80|0.85
72460237|NCT01885559|144443632|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.82||||0.57|TWO_SIDED|95.0|0.42|1.6|||Regression, Cox|adjusting for age, sex, race, and clinical site and accounting for recurrent events|Hazard ratio is comparing ACE-I + ARB to ACE-I + placebo|||1.6|0.42|0.57
72460238|NCT01885559|144443633|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.032||||0.75|TWO_SIDED|95.0|-0.23|0.16|||shared parameter model|Shared parameter models were used due to informed censoring when patients who reached the primary endpoint were no longer assessed on the measure.||||0.16|-0.23|0.75
72460239|NCT01885559|144443634|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.047||||0.66|TWO_SIDED|95.0|-0.26|0.16|||shared parameter model|Shared parameter models were used due to the informative censoring when patients who reached endpoint were not longer assessed on this measure.||||0.16|-0.26|0.66
72460240|NCT01885559|144443635|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.0||||0.64|TWO_SIDED|95.0|0.99|1.01|||Mixed Models Analysis|Generalized linear mixed models are used with a logit link. Model controlled for baseline age, sex, race, and clinical site.|"Odds ratio represents the multiplicative effect of ACE-I + ARB group compared to the ACE-I + placebo group in change in pain over time.~ACE-I + ARB OR per month was 1.01 (1.00, 1.01) and ACE-I + placebo OR was 1.01 (1.01, 1.01)."|||1.01|0.99|0.64
72460241|NCT06466655|144443664|EQUIVALENCE||||||>|0.05|||||||t-test, 2 sided|||||||>0.05
72460242|NCT06466655|144443665|EQUIVALENCE||||||>|0.05|||||||t-test, 2 sided|||||||>0.05
72563344|NCT00442546|144658169|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.81|STANDARD_ERROR_OF_MEAN|0.501||0.0004||95.0|-2.798|-0.822|||ANOVA||Mean difference (final values) = Least squares mean difference|24 hours||-0.822|-2.798|0.0004
72460243|NCT02819141|144443666|SUPERIORITY|||||||0.3||||||A priori threshold for statistical significance was p \< 0.05.|Generalized estimating equations|Controlling for age, daily sequential organ failure assessment (SOFA) score, sedation intensity, and time of day of assessment||We estimated the power for multilevel models approximating our study design. A sample size of 95 patients per arm, 190 total (at a minimum 7 data collection points for each, resulting in \~1,050 observations) will have greater than 80% power to detect small to moderate effects (i.e., 0.11 or greater) in between-group differences in anxiety, delirium, and duration of mechanical ventilation at alpha = .05 for all proposed models.||||0.30
72460244|NCT02819141|144443666|SUPERIORITY|Controlling for time of day, study day, age, sex, illness severity, and sedation frequency||||||0.9858|||||||Generalized Estimating equations|||||||0.9858
72460245|NCT02819141|144443667|SUPERIORITY|||||||0.02||||||a priori threshold for significance p \< 0.05.|t-test, 1 sided|||||||0.02
72460246|NCT02819141|144443668|SUPERIORITY|||||||0.97|||||||Generalized estimating equations|Controlling for sedation intensity, age, daily Sequential Organ Failure Assessment (SOFA) score, study day, and time of day assessment||||||0.97
72460247|NCT02819141|144443668|SUPERIORITY|||||||0.5647|||||||Generalized estimating equations|Controlling for sedation frequency, age, sex, illness severity, study day, and time of day assessment.||||||0.5647
72460248|NCT02819141|144443669|SUPERIORITY|||||||0.39|||||||Generalized estimating equation|controlling for age, daily Sequential Organ Failure Assessment (SOFA) score, time of day of assessment||||||0.39
72460249|NCT02819141|144443670|SUPERIORITY|||||||0.37|||||||GEE|||||||0.37
72460250|NCT02819141|144443671|SUPERIORITY|||||||0.17|||||||t-test, 1 sided|||||||0.17
72460251|NCT02819141|144443671|SUPERIORITY|||||||0.81|||||||t-test, 1 sided|||||||0.81
72460252|NCT02819141|144443672|SUPERIORITY|||||||0.47|||||||t-test, 1 sided|||||||0.47
72370548|NCT00488683|144251633|SUPERIORITY_OR_OTHER||R-square|0.6||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and memory B cells rise from pre-booster to one month after booster vaccination for the serogroup Y||||
72460253|NCT02819141|144443672|SUPERIORITY|||||||0.82|||||||t-test, 1 sided|||||||0.82
72460254|NCT02819141|144443673|SUPERIORITY|||||||0.164|||||||t-test, 1 sided|||3 months after ICU discharge||||0.164
72460255|NCT02819141|144443673|SUPERIORITY|||||||0.84|||||||t-test, 1 sided|||6 months after ICU discharge||||0.84
72460256|NCT02819141|144443674|SUPERIORITY|||||||0.26|||||||t-test, 1 sided|||||||0.26
72460257|NCT02819141|144443675|SUPERIORITY|||||||0.82|||||||t-test, 1 sided|||||||0.82
72460258|NCT02819141|144443676|SUPERIORITY|||||||0.018|||||||t-test, 1 sided|||||||0.018
72460259|NCT02819141|144443677|SUPERIORITY|||||||0.66|||||||t-test, 1 sided|||||||0.66
72460260|NCT02819141|144443678|SUPERIORITY|||||||0.63|||||||t-test, 1 sided|||||||0.63
72460261|NCT02819141|144443679|SUPERIORITY|||||||0.41|||||||t-test, 1 sided|||||||0.41
72460262|NCT02819141|144443680|SUPERIORITY|||||||0.06|||||||t-test, 1 sided|||||||0.06
72460263|NCT02819141|144443681|SUPERIORITY|||||||0.93|||||||t-test, 1 sided|||||||0.93
72460264|NCT02819141|144443682|SUPERIORITY|||||||0.43|||||||t-test, 1 sided|||||||0.43
72460265|NCT02819141|144443683|SUPERIORITY|||||||0.69|||||||t-test, 1 sided|||||||0.69
72460266|NCT02819141|144443684|SUPERIORITY|||||||0.94|||||||t-test, 1 sided|||||||0.94
72460267|NCT02819141|144443685|SUPERIORITY|||||||0.5|||||||t-test, 1 sided|||||||0.50
72460268|NCT02819141|144443686|SUPERIORITY|||||||0.03|||||||t-test, 1 sided|||||||0.03
72460269|NCT02819141|144443687|SUPERIORITY|||||||0.17|||||||t-test, 1 sided|||||||0.17
72460270|NCT02819141|144443688|SUPERIORITY|||||||0.85|||||||t-test, 1 sided|||||||0.85
72460271|NCT02819141|144443689|SUPERIORITY|||||||0.95|||||||t-test, 1 sided|||||||0.95
72460272|NCT06091982|144443729|SUPERIORITY||Odds Ratio (OR)|10.6|||<|0.0001|TWO_SIDED|95.0|7.0|16.2|||Chi-squared|||Bivariable analysis of both groups||16.2|7.0|<0.0001
72460273|NCT06091982|144443729|OTHER|Multiple logistic regression|Odds Ratio, log|3.4|||<|0.0001|TWO_SIDED|95.0|2.0|6.1|||Regression, Logistic|||Multivariable analysis||6.1|2.0|<0.0001
72460274|NCT06091982|144443730|SUPERIORITY||Odds Ratio (OR)|12.5|||<|0.0001|TWO_SIDED|95.0|9.1|17.1|||Chi-squared|||||17.1|9.1|<0.0001
72460275|NCT06091982|144443730|SUPERIORITY||Odds Ratio, log|4.4|||<|0.0001|TWO_SIDED|95.0|2.8|7.0|||Regression, Logistic|||||7.0|2.8|<0.0001
72460276|NCT06091982|144443731|SUPERIORITY||Odds Ratio (OR)|15.6|||<|0.0001|TWO_SIDED|95.0|11.3|21.6|||Chi-squared|||||21.6|11.3|<0.0001
72460277|NCT06091982|144443731|OTHER||Odds Ratio, log|5.2|||<|0.0001|TWO_SIDED|95.0|3.3|8.2|||Regression, Logistic|||||8.2|3.3|<0.0001
72460278|NCT03694210|144443789|SUPERIORITY||Mean Difference (Net)|0.0||||0.0011|TWO_SIDED|||||p-values of \<0.05 are considered significant.|Wilcoxon Signed Rank Test|||Physical Functioning: 21 Day Post Necrosectomy SF-36v1 Score is compared to Baseline score for improvement.||||0.0011
72460279|NCT03694210|144443789|SUPERIORITY||Mean Difference (Net)|0.0||||0.1152|TWO_SIDED|||||p-values of \<0.05 are considered significant|Wilcoxon Signed Rank Test|||Role Limitations due to Physical Health: 21 Day Post Necrosectomy SF-36v1 Score is compared to Baseline score for improvement.||||0.1152
72460280|NCT03694210|144443789|SUPERIORITY||Mean Difference (Net)|0.0||||0.0552|TWO_SIDED|||||p-values of \<0.05 are considered significant|Wilcoxon Signed Rank Test|||Role Limitations due to Emotional Problems: 21 Day Post Necrosectomy SF-36v1 Score is compared to Baseline score for improvement.||||0.0552
72460281|NCT03694210|144443789|SUPERIORITY||Mean Difference (Net)|0.0||||0.039|TWO_SIDED|||||p-values of \<0.05 are considered significant|Wilcoxon Signed Rank Test|||Energy/Fatigue: 21 Day Post Necrosectomy SF-36v1 Score is compared to Baseline score for improvement.||||0.039
72460282|NCT03694210|144443789|SUPERIORITY||Mean Difference (Net)|0.0||||0.0223|TWO_SIDED|||||p-values of \<0.05 are considered significant|Wilcoxon Signed Rank Test|||Emotional Well Being: 21 Day Post Necrosectomy SF-36v1 Score is compared to Baseline score for improvement.||||0.0223
72460283|NCT03694210|144443789|SUPERIORITY||Mean Difference (Net)|0.0||||0.4664|TWO_SIDED|||||p-values of \<0.05 are considered significant|Wilcoxon Signed Rank Test|||Social Functioning: 21 Day Post Necrosectomy SF-36v1 Score is compared to Baseline score for improvement.||||0.4664
72460284|NCT03694210|144443789|SUPERIORITY||Mean Difference (Net)|0.0||||0.0001|TWO_SIDED|||||p-values of \<0.05 are considered significant|Wilcoxon Signed Rank Test|||Pain: 21 Day Post Necrosectomy SF-36v1 Score is compared to Baseline score for improvement.||||0.0001
72620973|NCT00562861|144772886|SUPERIORITY_OR_OTHER||F value|1.88||||0.17|TWO_SIDED||||||Mixed Models Analysis|||||||0.17
72460285|NCT03694210|144443789|SUPERIORITY||Mean Difference (Net)|0.0||||0.0639|TWO_SIDED|||||p-values of \<0.05 are considered significant|Wilcoxon Signed Rank Test|||General Health: 21 Day Post Necrosectomy SF-36v1 Score is compared to Baseline score for improvement.||||0.0639
72460286|NCT01375777|144443791|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-47.23|STANDARD_ERROR_OF_MEAN|3.7|<|0.001|TWO_SIDED|95.0|-54.52|-39.93||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|ANCOVA|The ANCOVA model included treatment group and the stratification factor.|Placebo is the reference|The null hypothesis was that there was no mean difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.||-39.93|-54.52|<0.001
72501185|NCT00996840|144532235|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.965|STANDARD_ERROR_OF_MEAN|0.137|||TWO_SIDED|95.0|0.733|1.269||||||Comparison at 12 h post first dose||1.269|0.733|
72501186|NCT00996840|144532235|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.992|STANDARD_ERROR_OF_MEAN|0.168|||TWO_SIDED|95.0|0.71|1.387||||||Comparison at 18 h post first dose||1.387|0.710|
72501187|NCT00996840|144532235|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.913|STANDARD_ERROR_OF_MEAN|0.171|||TWO_SIDED|95.0|0.649|1.285||||||Comparison at 24 h post first dose||1.285|0.649|
72501188|NCT00996840|144532235|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.66|STANDARD_ERROR_OF_MEAN|0.233|||TWO_SIDED|95.0|0.415|1.051||||||Comparison at 48 h post first dose||1.051|0.415|
72501189|NCT00996840|144532235|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.69|STANDARD_ERROR_OF_MEAN|0.22|||TWO_SIDED|95.0|0.445|1.072||||||Comparison at 72 h post first dose||1.072|0.445|
72501190|NCT00996840|144532235|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.724|STANDARD_ERROR_OF_MEAN|0.268|||TWO_SIDED|95.0|0.423|1.239||||||Comparison at 96 h post first dose||1.239|0.423|
72501191|NCT00996840|144532235|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.95|STANDARD_ERROR_OF_MEAN|0.093|||TWO_SIDED|95.0|0.789|1.144||||||Comparison at 6 h post first dose||1.144|0.789|
72501192|NCT00996840|144532235|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.985|STANDARD_ERROR_OF_MEAN|0.119|||TWO_SIDED|95.0|0.777|1.249||||||Comparison at 12 h post first dose||1.249|0.777|
72501193|NCT00996840|144532235|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|1.067|STANDARD_ERROR_OF_MEAN|0.146|||TWO_SIDED|95.0|0.797|1.428||||||Comparison at 18 h post first dose||1.428|0.797|
72501194|NCT00996840|144532235|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.922|STANDARD_ERROR_OF_MEAN|0.148|||TWO_SIDED|95.0|0.686|1.239||||||Comparison at 24 h post first dose||1.239|0.686|
72501195|NCT00996840|144532235|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.866|STANDARD_ERROR_OF_MEAN|0.198|||TWO_SIDED|95.0|0.583|1.287||||||Comparison at 48 h post first dose||1.287|0.583|
72501196|NCT00996840|144532235|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.649|STANDARD_ERROR_OF_MEAN|0.19|||TWO_SIDED|95.0|0.444|0.95||||||Comparison at 72 h post first dose||0.950|0.444|
72501197|NCT00996840|144532235|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.722|STANDARD_ERROR_OF_MEAN|0.228|||TWO_SIDED|95.0|0.457|1.14||||||Comparison at 96 h post first dose||1.140|0.457|
72501198|NCT00996840|144532235|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.897|STANDARD_ERROR_OF_MEAN|0.091|||TWO_SIDED|95.0|0.748|1.075||||||Comparison at 6 h post first dose||1.075|0.748|
72501199|NCT00996840|144532235|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.887|STANDARD_ERROR_OF_MEAN|0.116|||TWO_SIDED|95.0|0.703|1.119||||||Comparison at 12 h post first dose||1.119|0.703|
72501200|NCT00996840|144532235|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.846|STANDARD_ERROR_OF_MEAN|0.142|||TWO_SIDED|95.0|0.638|1.123||||||Comparison at 18 h post first dose||1.123|0.638|
72563345|NCT00442546|144658169|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.197|STANDARD_ERROR_OF_MEAN|0.405||0.6274||95.0|-0.995|0.601|||ANOVA||Mean difference (final values) = Least squares mean difference|48 hours||0.601|-0.995|0.6274
72501201|NCT00996840|144532235|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.812|STANDARD_ERROR_OF_MEAN|0.145|||TWO_SIDED|95.0|0.609|1.084||||||Comparison at 24 h post first dose||1.084|0.609|
72501202|NCT00996840|144532235|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.58|STANDARD_ERROR_OF_MEAN|0.194|||TWO_SIDED|95.0|0.394|0.855||||||Comparison at 48 h post first dose||0.855|0.394|
72501203|NCT00996840|144532235|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.439|STANDARD_ERROR_OF_MEAN|0.188|||TWO_SIDED|95.0|0.301|0.639||||||Comparison at 72 h post first dose||0.639|0.301|
72501204|NCT00996840|144532235|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.451|STANDARD_ERROR_OF_MEAN|0.23|||TWO_SIDED|95.0|0.285|0.714||||||Comparison at 96 h post first dose||0.714|0.285|
72501205|NCT00996840|144532236|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.85|STANDARD_ERROR_OF_MEAN|0.137|||TWO_SIDED|95.0|0.646|1.119||||||Comparison at 6 h post first dose||1.119|0.646|
72563346|NCT00442546|144658169|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.619|STANDARD_ERROR_OF_MEAN|0.413||0.135||95.0|-1.432|0.194|||ANOVA||Mean difference (final values) = Least squares mean difference|48 hours||0.194|-1.432|0.1350
72501206|NCT00996840|144532236|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|1.072|STANDARD_ERROR_OF_MEAN|0.138|||TWO_SIDED|95.0|0.814|1.411||||||Comparison at 12 h post first dose||1.411|0.814|
72501207|NCT00996840|144532236|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|1.08|STANDARD_ERROR_OF_MEAN|0.157|||TWO_SIDED|95.0|0.79|1.478||||||Comparison at 18 h post first dose||1.478|0.790|
72501208|NCT00996840|144532236|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.951|STANDARD_ERROR_OF_MEAN|0.143|||TWO_SIDED|95.0|0.715|1.266||||||Comparison at 24 h post first dose||1.266|0.715|
72501209|NCT00996840|144532236|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.918|STANDARD_ERROR_OF_MEAN|0.168|||TWO_SIDED|95.0|0.655|1.285||||||Comparison at 48 h post first dose||1.285|0.655|
72501210|NCT00996840|144532236|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|1.012|STANDARD_ERROR_OF_MEAN|0.16|||TWO_SIDED|95.0|0.735|1.395||||||Comparison at 72 h post first dose||1.395|0.735|
72501211|NCT00996840|144532236|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|1.168|STANDARD_ERROR_OF_MEAN|0.169|||TWO_SIDED|95.0|0.831|1.64||||||Comparison at 96 h post first dose||1.640|0.831|
72501212|NCT00996840|144532236|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.912|STANDARD_ERROR_OF_MEAN|0.124|||TWO_SIDED|95.0|0.713|1.167||||||Comparison at 6 h post first dose||1.167|0.713|
72501213|NCT00996840|144532236|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.963|STANDARD_ERROR_OF_MEAN|0.123|||TWO_SIDED|95.0|0.753|1.233||||||Comparison at 12 h post first dose||1.233|0.753|
72501214|NCT00996840|144532236|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.917|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|0.693|1.214||||||Comparison at 18 h post first dose||1.214|0.693|
72563347|NCT00442546|144658169|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.719|STANDARD_ERROR_OF_MEAN|0.448||0.1106||95.0|-1.605|0.166|||ANOVA||Mean difference (final values) = Least squares mean difference|72 hours||0.166|-1.605|0.1106
72460287|NCT01375777|144443791|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-40.17|STANDARD_ERROR_OF_MEAN|3.66|<|0.001||95.0|-47.38|-32.95||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|ANCOVA|The ANCOVA model included treatment group and the stratification factor.|Placebo is the reference|The null hypothesis was that there was no mean difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.||-32.95|-47.38|<0.001
72460288|NCT01375777|144443791|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-32.27|STANDARD_ERROR_OF_MEAN|3.68|<|0.001|TWO_SIDED|95.0|-44.53|-30.02||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|ANCOVA|The ANCOVA model included treatment group and the stratification factor.|Placebo is the reference|The null hypothesis was that there was no mean difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.||-30.02|-44.53|<0.001
72460289|NCT01375777|144443791|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-52.53|STANDARD_ERROR_OF_MEAN|3.62|<|0.001|TWO_SIDED|95.0|-59.67|-45.38||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|ANCOVA|The ANCOVA model included treatment group and the stratification factor.|Placebo is the reference|The null hypothesis was that there was no mean difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.||-45.38|-59.67|<0.001
72460290|NCT01375777|144443791|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-47.74|STANDARD_ERROR_OF_MEAN|3.62|<|0.001|TWO_SIDED|95.0|-54.89|-40.6||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|ANCOVA|The ANCOVA model included treatment group and the stratification factor.|Placebo is the reference|The null hypothesis was that there was no mean difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.||-40.60|-54.89|<0.001
72460291|NCT01375777|144443791|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-43.57|STANDARD_ERROR_OF_MEAN|3.62|<|0.001|TWO_SIDED|95.0|-50.71|-36.42||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|ANCOVA|The ANCOVA model included treatment group and the stratification factor.|Placebo is the reference|The null hypothesis was that there was no mean difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.||-36.42|-50.71|<0.001
72460292|NCT01375777|144443792|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-65.9|STANDARD_ERROR_OF_MEAN|5.2|<|0.001|TWO_SIDED|95.0|-76.3|-55.6||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and the stratification factor.|Placebo is the reference|||-55.6|-76.3|<0.001
72460293|NCT01375777|144443792|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-62.7|STANDARD_ERROR_OF_MEAN|5.3|<|0.001||95.0|-73.2|-52.2||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and the stratification factor.|Placebo is the reference|||-52.2|-73.2|<0.001
72460294|NCT01375777|144443792|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-52.3|STANDARD_ERROR_OF_MEAN|5.3|<|0.001|TWO_SIDED|95.0|-62.7|-41.9||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and the stratification factor.|Placebo is the reference|||-41.9|-62.7|<0.001
72460295|NCT01375777|144443792|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-72.3|STANDARD_ERROR_OF_MEAN|5.0|<|0.001|TWO_SIDED|95.0|-82.2|-62.4||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and the stratification factor.|Placebo is the reference|||-62.4|-82.2|<0.001
72460296|NCT01375777|144443792|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-63.9|STANDARD_ERROR_OF_MEAN|5.0|<|0.001|TWO_SIDED|95.0|-73.9|-54.0||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and the stratification factor.|Placebo is the reference|||-54.0|-73.9|<0.001
72460297|NCT01375777|144443792|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-60.8|STANDARD_ERROR_OF_MEAN|5.0|<|0.001|TWO_SIDED|95.0|-70.7|-50.9||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and the stratification factor.|Placebo is the reference|||-50.9|-70.7|<0.001
72460298|NCT01375777|144443793|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-45.15|STANDARD_ERROR_OF_MEAN|3.33|<|0.001|TWO_SIDED|95.0|-51.72|-38.58||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and the stratification factor.|Placebo is the reference|||-38.58|-51.72|<0.001
72460299|NCT01375777|144443793|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-36.79|STANDARD_ERROR_OF_MEAN|3.29|<|0.001||95.0|-43.29|-30.29||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and the stratification factor.|Placebo is the reference|||-30.29|-43.29|<0.001
72460300|NCT01375777|144443793|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-35.06|STANDARD_ERROR_OF_MEAN|3.31|<|0.001|TWO_SIDED|95.0|-41.59|-28.52||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and the stratification factor.|Placebo is the reference|||-28.52|-41.59|<0.001
72460301|NCT01375777|144443793|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-47.11|STANDARD_ERROR_OF_MEAN|3.15|<|0.001|TWO_SIDED|95.0|-53.33|-40.89||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and the stratification factor.|Placebo is the reference|||-40.89|-53.33|<0.001
72460302|NCT01375777|144443793|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-41.89|STANDARD_ERROR_OF_MEAN|3.15|<|0.001|TWO_SIDED|95.0|-48.11|-35.67||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and the stratification factor.|Placebo is the reference|||-35.67|-48.11|<0.001
72501215|NCT00996840|144532236|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.87|STANDARD_ERROR_OF_MEAN|0.128|||TWO_SIDED|95.0|0.673|1.123||||||Comparison at 24 h post first dose||1.123|0.673|
72501216|NCT00996840|144532236|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|1.141|STANDARD_ERROR_OF_MEAN|0.153|||TWO_SIDED|95.0|0.84|1.55||||||Comparison at 48 h post first dose||1.550|0.840|
72370549|NCT00488683|144251633|SUPERIORITY_OR_OTHER||R-square|0.01||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between memory B cells one month after primary vaccination and memory B cells rise from pre-booster to one month after booster vaccination for the serogroup Y||||
72460303|NCT01375777|144443793|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-37.7|STANDARD_ERROR_OF_MEAN|3.15|<|0.001|TWO_SIDED|95.0|-43.92|-31.47||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and the stratification factor.|Placebo is the reference|||-31.47|-43.92|<0.001
72460304|NCT01375777|144443794|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-44.19|STANDARD_ERROR_OF_MEAN|3.17|<|0.001|TWO_SIDED|95.0|-50.45|-37.94||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and the stratification factor.|Placebo is the reference|||-37.94|-50.45|<0.001
72460305|NCT01375777|144443794|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-35.87|STANDARD_ERROR_OF_MEAN|3.13|<|0.001||95.0|-42.06|-29.69||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and the stratification factor.|Placebo is the reference|||-29.69|-42.06|<0.001
72460306|NCT01375777|144443794|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-32.33|STANDARD_ERROR_OF_MEAN|3.15|<|0.001|TWO_SIDED|95.0|-38.55|-26.11||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and the stratification factor.|Placebo is the reference|||-26.11|-38.55|<0.001
72460307|NCT01375777|144443794|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-42.48|STANDARD_ERROR_OF_MEAN|3.12|<|0.001|TWO_SIDED|95.0|-48.63|-36.32||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and the stratification factor.|Placebo is the reference|||-36.32|-48.63|<0.001
72460308|NCT01375777|144443794|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-37.92|STANDARD_ERROR_OF_MEAN|3.12|<|0.001|TWO_SIDED|95.0|-44.07|-31.76||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and the stratification factor.|Placebo is the reference|||-31.76|-44.07|<0.001
72460309|NCT01375777|144443794|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-33.22|STANDARD_ERROR_OF_MEAN|3.12|<|0.001|TWO_SIDED|95.0|-39.38|-27.07||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and the stratification factor.|Placebo is the reference|||-27.07|-39.38|<0.001
72460310|NCT01375777|144443795|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-37.49|STANDARD_ERROR_OF_MEAN|3.01|<|0.001|TWO_SIDED|95.0|-43.43|-31.54||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and the stratification factor.|Placebo is the reference|||-31.54|-43.43|<0.001
72460311|NCT01375777|144443795|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-31.92|STANDARD_ERROR_OF_MEAN|2.98|<|0.001||95.0|-37.79|-26.04||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and the stratification factor.|Placebo is the reference|||-26.04|-37.79|<0.001
72460312|NCT01375777|144443795|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-28.86|STANDARD_ERROR_OF_MEAN|2.99|<|0.001|TWO_SIDED|95.0|-34.77|-22.95||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and the stratification factor.|Placebo is the reference|||-22.95|-34.77|<0.001
72460313|NCT01375777|144443795|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-36.58|STANDARD_ERROR_OF_MEAN|2.89|<|0.001|TWO_SIDED|95.0|-42.29|-30.88||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and the stratification factor.|Placebo is the reference|||-30.88|-42.29|<0.001
72460314|NCT01375777|144443795|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-31.21|STANDARD_ERROR_OF_MEAN|2.89|<|0.001|TWO_SIDED|95.0|-36.92|-25.51||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and the stratification factor.|Placebo is the reference|||-25.51|-36.92|<0.001
72460315|NCT01375777|144443795|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-28.69|STANDARD_ERROR_OF_MEAN|2.89|<|0.001|TWO_SIDED|95.0|-34.39|-22.98||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and the stratification factor.|Placebo is the reference|||-22.98|-34.39|<0.001
72460316|NCT01375777|144443796|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-50.16|STANDARD_ERROR_OF_MEAN|3.34|<|0.001|TWO_SIDED|95.0|-56.75|-43.58||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and the stratification factor.|Placebo is the reference|||-43.58|-56.75|<0.001
72460317|NCT01375777|144443796|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-40.33|STANDARD_ERROR_OF_MEAN|3.3|<|0.001||95.0|-46.84|-33.82||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and the stratification factor.|Placebo is the reference|||-33.82|-46.84|<0.001
72460318|NCT01375777|144443796|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-34.83|STANDARD_ERROR_OF_MEAN|3.32|<|0.001|TWO_SIDED|95.0|-41.38|-28.28||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and the stratification factor.|Placebo is the reference|||-28.28|-41.38|<0.001
72460319|NCT01375777|144443796|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-45.47|STANDARD_ERROR_OF_MEAN|3.37|<|0.001|TWO_SIDED|95.0|-52.12|-38.82||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and the stratification factor.|Placebo is the reference|||-38.82|-52.12|<0.001
72501217|NCT00996840|144532236|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|1.122|STANDARD_ERROR_OF_MEAN|0.146|||TWO_SIDED|95.0|0.837|1.505||||||Comparison at 72 h post first dose||1.505|0.837|
72501218|NCT00996840|144532236|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|1.474|STANDARD_ERROR_OF_MEAN|0.164|||TWO_SIDED|95.0|1.063|2.045||||||Comparison at 96 h post first dose||2.045|1.063|
72460320|NCT01375777|144443796|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-40.57|STANDARD_ERROR_OF_MEAN|3.37|<|0.001|TWO_SIDED|95.0|-47.22|-33.92||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and the stratification factor.|Placebo is the reference|||-33.92|-47.22|<0.001
72460321|NCT01375777|144443796|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-36.25|STANDARD_ERROR_OF_MEAN|3.37|<|0.001|TWO_SIDED|95.0|-42.9|-29.6||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and the stratification factor.|Placebo is the reference|||-29.60|-42.90|<0.001
72460322|NCT01838499|144443804|SUPERIORITY_OR_OTHER||Difference in proportions|0.051|||>|0.05|TWO_SIDED|80.0|-0.067|0.169|||Mixed Models Analysis||MEDI8968 - placebo|Analysis of proportion of Responders for Physician's Global Assessment (PGA score 0, 1 or 2) at Week 12 - LOCF. Difference in proportions MEDI8968 - placebo. Wald asymptotic confidence limits calculated.||0.169|-0.067|>0.05
72501219|NCT00996840|144532236|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.833|STANDARD_ERROR_OF_MEAN|0.107|||TWO_SIDED|95.0|0.672|1.031||||||Comparison at 6 h post first dose||1.031|0.672|
72460323|NCT01838499|144443805|SUPERIORITY_OR_OTHER||Difference in proportions|-0.065|||>|0.05|TWO_SIDED|80.0|-0.205|0.076|||Mixed Models Analysis|||Difference in proportions MEDI8968 - placebo. Wald asymptotic confidence limits calculated.||0.076|-0.205|>0.05
72460324|NCT01838499|144443806|SUPERIORITY_OR_OTHER||Change from baseline (at week 12)|-0.03||||0.945|TWO_SIDED|80.0|-0.63|0.57|||ANCOVA||MEDI8968 - Placebo|Analysis of change from baseline (Week 12) estimated from ANCOVA model with tmt group and PGA stratum at randomisation included in the model and average daily pain at baseline as a covariate||0.57|-0.63|0.945
72460325|NCT01136733|144443809|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.4|||=|0.0005|TWO_SIDED|95.0|0.24|0.68|||Log Rank||Hazard ratio between treatment groups and corresponding 95% CI was estimated using the stratified Cox regression model (stratified by hemoglobin and corrected serum calcium) with treatment as a factor.|Null hypothesis of no difference in PFS was analyzed using the stratified log-rank test with hemoglobin (less than or equal to 13 g/dL vs greater than 13 g/dL for males; and less than or equal to 11.5 g/dL vs greater than 11.5 g/dL for females) and corrected serum calcium (greater than or equal to 10 mg/dL vs less than 10 mg/dL) as stratification factors. Each null hypothesis was tested at a nominal alpha=0.05.||0.68|0.24|=0.0005
72460326|NCT01136733|144443809|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.61||||0.0479|TWO_SIDED|95.0|0.38|0.98|||Log Rank|||||0.98|0.38|0.0479
72460327|NCT01136733|144443809|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.66||||0.1209|TWO_SIDED|95.0|0.39|1.1|||Log Rank|||||1.10|0.39|0.1209
72460328|NCT01136733|144443810|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.514|||=|0.0242|TWO_SIDED|95.0|0.299|0.884|||Log Rank||Hazard ratio between treatment groups and corresponding 95% CI was estimated using the stratified Cox regression model (stratified by hemoglobin and corrected serum calcium) with treatment as a factor.|Planned analyses were performed to test null hypothesis of treatment difference in OS at a nominal significance level of 0.05 (2-sided) using the stratified log-rank test using stratification factors.||0.884|0.299|=0.0242
72501220|NCT00996840|144532236|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.879|STANDARD_ERROR_OF_MEAN|0.109|||TWO_SIDED|95.0|0.707|1.092||||||Comparison at 12 h post first dose||1.092|0.707|
72501221|NCT00996840|144532236|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|1.023|STANDARD_ERROR_OF_MEAN|0.123|||TWO_SIDED|95.0|0.8|1.307||||||Comparison at 18 h post first dose||1.307|0.800|
72501222|NCT00996840|144532236|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.95|STANDARD_ERROR_OF_MEAN|0.111|||TWO_SIDED|95.0|0.761|1.187||||||Comparison at 24 h post first dose||1.187|0.761|
72501223|NCT00996840|144532236|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.968|STANDARD_ERROR_OF_MEAN|0.132|||TWO_SIDED|95.0|0.743|1.262||||||Comparison at 48 h post first dose||1.262|0.743|
72501224|NCT00996840|144532236|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.926|STANDARD_ERROR_OF_MEAN|0.127|||TWO_SIDED|95.0|0.718|1.193||||||Comparison at 72 h post first dose||1.193|0.718|
72460329|NCT01136733|144443810|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.684|||=|0.1181|TWO_SIDED|95.0|0.411|1.138|||Log Rank|||||1.138|0.411|=0.1181
72460330|NCT01136733|144443810|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.751|||=|0.3157|TWO_SIDED|95.0|0.433|1.301|||Log Rank|||||1.301|0.433|=0.3157
72501225|NCT00996840|144532236|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|1.229|STANDARD_ERROR_OF_MEAN|0.136|||TWO_SIDED|95.0|0.936|1.613||||||Comparison at 96 h post first dose||1.613|0.936|
72501226|NCT00996840|144532236|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.923|STANDARD_ERROR_OF_MEAN|0.102|||TWO_SIDED|95.0|0.753|1.131||||||Comparison at 6 h post first dose||1.131|0.753|
72501227|NCT00996840|144532236|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.768|STANDARD_ERROR_OF_MEAN|0.103|||TWO_SIDED|95.0|0.625|0.943||||||Comparison at 12 h post first dose||0.943|0.625|
72501228|NCT00996840|144532236|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.826|STANDARD_ERROR_OF_MEAN|0.116|||TWO_SIDED|95.0|0.655|1.042||||||Comparison at 18 h post first dose||1.042|0.655|
72501229|NCT00996840|144532236|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.761|STANDARD_ERROR_OF_MEAN|0.106|||TWO_SIDED|95.0|0.615|0.942||||||Comparison at 24 h post first dose||0.942|0.615|
72501230|NCT00996840|144532236|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.781|STANDARD_ERROR_OF_MEAN|0.125|||TWO_SIDED|95.0|0.608|1.003||||||Comparison at 48 h post first dose||1.003|0.608|
72501231|NCT00996840|144532236|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.668|STANDARD_ERROR_OF_MEAN|0.121|||TWO_SIDED|95.0|0.524|0.851||||||Comparison at 72 h post first dose||0.851|0.524|
72501232|NCT00996840|144532236|OTHER||Ratio (Treatment/Placebo)|0.86|STANDARD_ERROR_OF_MEAN|0.133|||TWO_SIDED|95.0|0.659|1.122||||||Comparison at 96 h post first dose||1.122|0.659|
72501233|NCT01485614|144532260|SUPERIORITY||Least Squares Means Difference|-0.19|||=|0.448|TWO_SIDED|95.0|-0.68|0.3|||Mixed Models Analysis|"The Least Squares (LS) Mean for the arm Sitagliptin is compared against that of Placebo (pooled)."||||0.30|-0.68|= 0.448
72460331|NCT01136733|144443811|SUPERIORITY_OR_OTHER||Rate ratio|7.2|||<|0.0001|TWO_SIDED|95.0|2.3|22.5||Analysis performed after database lock. P-value was based on the 2-sided Fisher's exact P-value.|Fisher Exact||Rate ratio was based on the normal approximation.|||22.5|2.3|<0.0001
72460332|NCT01136733|144443811|SUPERIORITY_OR_OTHER||Rate ratio|4.5||||0.0067|TWO_SIDED|95.0|1.4|14.7||Analysis performed after database lock. P-value was based on the 2-sided Fisher's exact P-value.|Fisher Exact|||||14.7|1.4|0.0067
72460333|NCT01136733|144443811|SUPERIORITY_OR_OTHER||Rate ratio|1.6|||=|0.1007|TWO_SIDED|95.0|0.9|2.8||Analysis performed after database lock. P-value was based on the 2-sided Fisher's exact P-value.|Fisher Exact|||||2.8|0.9|=0.1007
72501234|NCT01485614|144532262|OTHER||Difference in Percentage|2.4|||||TWO_SIDED|95.0|-10.0|14.9||"Percentage of participants with ≥1 adverse event for the arm Sitagliptin was compared against that of Placebo/Metformin with Miettinen \& Nurminen."||||||14.9|-10.0|
72501235|NCT01485614|144532264|OTHER||Difference in percentage|4.2|||||TWO_SIDED|95.0|-1.3|10.8||"Percentage of participants with ≥1 adverse event for the arm Sitagliptin was compared against that of Placebo/Metformin with Miettinen \& Nurminen."||||||10.8|-1.3|
72501236|NCT01485614|144532267|SUPERIORITY||Difference in percentage|6.7|||=|0.374|TWO_SIDED|95.0|-8.1|21.2||"Percentage of participants with an A1C goal (7.0%) in the arm Sitagliptin was compared against the arm Placebo (pooled)."|Miettinen and Nurminen||||For estimating the treatment difference, when the A1C result for a participant at Week 20 was not available, a multiple imputation method based on the Linear Discriminant Analysis (LDA) model was used to impute whether the participant had met the goal.|21.2|-8.1|= 0.374
72563348|NCT00442546|144658169|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.036|STANDARD_ERROR_OF_MEAN|0.457||0.0248||95.0|-1.939|-0.133|||ANOVA||Mean difference (final values) = Least squares mean difference|72 hours||-0.133|-1.939|0.0248
72392568|NCT02155608|144292444|SUPERIORITY|||||||0.33||||||p \< .05 for statistical significance.|Mixed Models Analysis|Time: F = .98, df = 1/54.||Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5.||||.33
72460334|NCT02105688|144443838|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||One-sided exact test|||A one-sided exact test was used to test the null hypothesis, which was that the SVR12 rate for the ITA was less than 67% (historical reference rate derived from NCT01667731). The p-value was based on a one-sided exact test for a binomial proportion. A one-sided p-value \<0.025 supports a conclusion that the true SVR12 is \>67%.||||<0.001
72460335|NCT02105688|144443839|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentage|0.2|||||TWO_SIDED|95.0|-8.3|10.0||||||Categorical AE parameters were assessed via point estimates with 95% confidence intervals provided for between-treatment differences in the percentage of participants with events using the Miettinen and Nurminen method, an unconditional, asymptotic method.||10.0|-8.3|
72460336|NCT02105688|144443840|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentage|-0.5|||||TWO_SIDED|95.0|-5.0|1.9||||||Categorical AE parameters were assessed via point estimates with 95% confidence intervals provided for between-treatment differences in the percentage of participants with events using the Miettinen and Nurminen method, an unconditional, asymptotic method.||1.9|-5.0|
72460337|NCT05878522|144443864|OTHER||LS Mean difference|11.73|||||TWO_SIDED|90.0|8.89|14.58||||||3- hours post-dose||14.58|8.89|
72460338|NCT05878522|144443864|OTHER||LS Mean difference|11.35|||||TWO_SIDED|90.0|8.5|14.2||||||4-hours post-dose||14.20|8.50|
72460339|NCT05878522|144443864|OTHER||LS Mean difference|8.35||||||90.0|5.51|11.2||||||5-hours post-dose||11.20|5.51|
72460340|NCT02252172|144443865|SUPERIORITY||Hazard Ratio (HR)|0.56|||<|0.0001|TWO_SIDED|95.0|0.43|0.73|||Log Rank|||||0.73|0.43|<0.0001
72460341|NCT01075815|144443910|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0235||||0.8762|TWO_SIDED|95.0|-0.1546|0.1568|||Wilcoxon two sample test|||||0.1568|-0.1546|0.8762
72501237|NCT01485614|144532269|SUPERIORITY||Difference in percentage|3.6|||=|0.639|TWO_SIDED|95.0|-11.6|18.3|||Miettinen and Nurminen|"The percentage of participants with an A1C at the A1C goal (6.5%) in the arm Sitagliptin was compared against the arm Placebo (pooled)."|||For estimating the treatment difference, when the A1C result for a participant at Week 20 was not available, a multiple imputation method based on the LDA model was used to impute whether the participant had met the goal.|18.3|-11.6|= 0.639
72501238|NCT01485614|144532274|SUPERIORITY||Least Squares Means Difference|1.5|||=|0.849|TWO_SIDED|95.0|-14.4|17.5|||Mixed Models Analysis|"The Least Squares (LS) Mean for the arm Sitagliptin was compared against that of Placebo (pooled)."||||17.5|-14.4|= 0.849
72501239|NCT00733902|144532350|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) Mean Difference|-0.73|STANDARD_ERROR_OF_MEAN|0.3||0.015|TWO_SIDED|95.0|-1.32|-0.14|||ANCOVA|||Analysis of Covariance (ANCOVA) was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.14|-1.32|0.015
72563349|NCT00442546|144658169|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.874|STANDARD_ERROR_OF_MEAN|0.725||0.2335||95.0|-0.582|2.33|||ANOVA||Mean difference (final values) = Least squares mean difference|96 hours||2.330|-0.582|0.2335
72563350|NCT00442546|144658169|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.568|STANDARD_ERROR_OF_MEAN|0.682||0.0258||95.0|-2.939|-0.198|||ANOVA||Mean difference (final values) = Least squares mean difference|96 hours||-0.198|-2.939|0.0258
72563351|NCT00442546|144658169|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.866|STANDARD_ERROR_OF_MEAN|1.973||0.3878||95.0|-3.207|6.939|||ANOVA||Mean difference (final values) = Least squares mean difference|120 hours||6.939|-3.207|0.3878
72563352|NCT00442546|144658169|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.909|STANDARD_ERROR_OF_MEAN|3.754||0.1762||95.0|-3.74|15.559|||ANOVA||Mean difference (final values) = Least squares mean difference|120 hours||15.559|-3.740|0.1762
72392569|NCT02155608|144292444|SUPERIORITY|||||||0.35||||||p \< .05 for statistical significance.|Mixed Models Analysis|Group \* time: F = .88, df = 1/54.||Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5.||||.35
72460342|NCT01075815|144443911|SUPERIORITY_OR_OTHER|||||||0.3589||95.0|||||ANOVA|||||||0.3589
72460343|NCT01075815|144443912|SUPERIORITY_OR_OTHER|||||||0.0629||95.0|||||Wilcoxon two sample test|||||||0.0629
72460344|NCT01075815|144443913|SUPERIORITY_OR_OTHER|||||||0.4728||95.0|||||ANOVA|||||||0.4728
72460345|NCT01075815|144443914|SUPERIORITY_OR_OTHER|||||||0.095||95.0|||||Fisher Exact|||||||0.0950
72460346|NCT01075815|144443916|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.9625||||0.9179|TWO_SIDED|95.0|0.4655|1.99|||Chi-squared|||||1.9900|0.4655|0.9179
72460347|NCT01075815|144443917|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.875||||0.7271|TWO_SIDED|95.0|0.4133|1.8524|||Chi-squared|||||1.8524|0.4133|0.7271
72460348|NCT01075815|144443918|SUPERIORITY_OR_OTHER|||||||0.3267||95.0|||||Wilcoxon two sample test|||||||0.3267
72460349|NCT01075815|144443919|SUPERIORITY_OR_OTHER|||||||0.4164||95.0|||||Wilcoxon two sample test|||||||0.4164
72460350|NCT01075815|144443920|SUPERIORITY_OR_OTHER|||||||0.5952||95.0|||||Wilcoxon two sample test|||||||0.5952
72460351|NCT01075815|144443922|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.9444||||0.8852|TWO_SIDED|95.0|0.4347|2.0518|||Chi-squared|||||2.0518|0.4347|0.8852
72460352|NCT03005106|144443950|OTHER|Difference between treatment and control sites|Mean Difference (Final Values)|97.77|||<|0.0001|TWO_SIDED|||||Difference is (percent area of Autograft treatment site requiring autografting by Month 3) - (percent area of StrataGraft treatment site requiring autografting by Month 3).|one-sided Wilcoxin Signed RankTtest|||||||<0.0001
72460353|NCT03005106|144443951|OTHER||Percentage of participants|83.1|||||TWO_SIDED|95.0|74.4|91.8|||||95% confidence interval is derived using the normal approximation to the binomial distribution|||91.8|74.4|
72563353|NCT00442546|144658169|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.515|STANDARD_ERROR_OF_MEAN|0.379||0.1754||95.0|-1.261|0.231|||ANOVA||Mean difference (final values) = Least squares mean difference|Discharge||0.231|-1.261|0.1754
72563354|NCT00442546|144658169|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.569|STANDARD_ERROR_OF_MEAN|0.386||0.1413||95.0|-1.329|0.191|||ANOVA||Mean difference (final values) = Least squares mean difference|Discharge||0.191|-1.329|0.1413
72460354|NCT03005106|144443952|OTHER|Difference is Autograft - StrataGraft|Mean Difference (Final Values)|2.4|||<|0.0001|TWO_SIDED||||||1-sided, paired t-test|p-value from 1-sided, paired t-test on the mean difference(Autograft - StrataGraft)||||||<0.0001
72460355|NCT03005106|144443953|OTHER|Difference is Autograft - StrataGraft|Mean Difference (Final Values)|10.0|||<|0.0001|TWO_SIDED|||||Missing total score data were imputed using a multiple imputation analysis assuming a monotone missing data pattern. A linear regression model with ethnicity, race and age as predictive variables was used in the imputation.|1-sided, paired t-test|p-value from 1-sided, paired t-test on the difference (Autograft - StrataGraft)||||||<0.0001
72460356|NCT00321672|144443954|SUPERIORITY_OR_OTHER|||||||0.0967||95.0||||All stastical tests of hypotheses were two-sided and at the 5% level of significance.|ANCOVA|Treatment differences were compared by a gender stratified analysis of covariance (ANCOVA) model with Baseline pain score as the only covariate.||The null hypothesis was that there was no difference between the average percent change in NPRS scores from baseline to weeks 2-12 between the total control and total NGX-4010 groups. The ratio of means between the 30- and 60-minute control group \[1.57 (90% CI: 1.12-2.35)\] was \> than the pre-specified equivalence margin ratio of 80-125%. Hence, the control groups could not be pooled and comparisons were performed between the 30- and 60-minute NGX-4010 groups and their respective control groups.||||0.0967
72460357|NCT00321672|144443954|SUPERIORITY_OR_OTHER|||||||0.4884||95.0||||All stastical tests of hypotheses were two-sided and at the 5% level of significance. No multiplicity adjustment were made.|ANCOVA|Treatment differences were compared by a gender stratified analysis of covariance (ANCOVA) model with Baseline pain score as the only covariate.||||||0.4884
72460358|NCT00321672|144443954|SUPERIORITY_OR_OTHER|||||||0.1031||95.0||||All stastical tests of hypotheses were two-sided and at the 5% level of significance. No multiplicity adjustment were made.|ANCOVA|Treatment differences were compared by a gender stratified analysis of covariance (ANCOVA) model with Baseline pain score as the only covariate.||||||0.1031
72460359|NCT00321672|144443955|SUPERIORITY_OR_OTHER|||||||0.0831||95.0||||All statistical tests of hypotheses were two-sided and at the 5% level of significance.|ANCOVA|Treatment differences were compared by a gender stratified analysis of covariance (ANCOVA) model with Baseline pain score as the only covariate.||"The null hypothesis was: There is no difference between the total Control and total NGX-4010 in the absolute change in NPRS scores from Baseline during Weeks 2-12."||||0.0831
72460360|NCT00321672|144443955|SUPERIORITY_OR_OTHER|||||||0.468||95.0||||All statistical tests of hypotheses were two-sided and at the 5% level of significance. No multiplicity adjustments were made.|ANCOVA|Treatment differences were compared by a gender stratified analysis of covariance (ANCOVA) model with Baseline pain score as the only covariate.||||||0.4680
72460361|NCT00321672|144443955|SUPERIORITY_OR_OTHER|||||||0.0896||95.0||||All statistical tests of hypotheses were two-sided and at the 5% level of significance. No multiplicity adjustments were made.|ANCOVA|Treatment differences were compared by a gender stratified analysis of covariance (ANCOVA) model with Baseline pain score as the only covariate.||||||0.0896
72501240|NCT00733902|144532350|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.84|STANDARD_ERROR_OF_MEAN|0.3||0.005|TWO_SIDED|95.0|-1.43|-0.25|||ANCOVA|||ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.25|-1.43|0.005
72501241|NCT00733902|144532350|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|0.3|<|0.001|TWO_SIDED|95.0|-1.78|-0.61|||ANCOVA|||ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.61|-1.78|<0.001
72501242|NCT00733902|144532351|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.75|STANDARD_ERROR_OF_MEAN|0.29||0.009|TWO_SIDED|95.0|-1.32|-0.19|||ANCOVA|||ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.19|-1.32|0.009
72501243|NCT00733902|144532351|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.98|STANDARD_ERROR_OF_MEAN|0.29|<|0.001|TWO_SIDED|95.0|-1.54|-0.41|||ANCOVA|||ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.41|-1.54|<0.001
72563355|NCT00442546|144658169|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.419|STANDARD_ERROR_OF_MEAN|0.306||0.1731||95.0|-1.023|0.185|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2||0.185|-1.023|0.1731
72563356|NCT00442546|144658169|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.128|STANDARD_ERROR_OF_MEAN|0.314||0.6829||95.0|-0.747|0.49|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2||0.490|-0.747|0.6829
72563357|NCT00442546|144658169|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.351|STANDARD_ERROR_OF_MEAN|0.3||0.2436||95.0|-0.943|0.241|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4||0.241|-0.943|0.2436
72563358|NCT00442546|144658169|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.49|STANDARD_ERROR_OF_MEAN|0.313||0.119||95.0|-1.108|0.127|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4||0.127|-1.108|0.1190
72501244|NCT00733902|144532351|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.24|STANDARD_ERROR_OF_MEAN|0.28|<|0.001|TWO_SIDED|95.0|-1.8|-0.68|||ANCOVA|||ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.68|-1.80|<0.001
72501245|NCT00733902|144532352|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.32|STANDARD_ERROR_OF_MEAN|0.1||0.001|TWO_SIDED|95.0|-0.52|-0.13|||ANCOVA|||ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.13|-0.52|0.001
72563359|NCT00442546|144658169|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.264|STANDARD_ERROR_OF_MEAN|0.321||0.4117||95.0|-0.897|0.369|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET||0.369|-0.897|0.4117
72563360|NCT00442546|144658169|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.156|STANDARD_ERROR_OF_MEAN|0.323||0.6294||95.0|-0.794|0.482|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET||0.482|-0.794|0.6294
72563361|NCT00442546|144658170|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.859|STANDARD_ERROR_OF_MEAN|3.315||0.7958||95.0|-7.391|5.673|||ANOVA||Mean difference (final values) = Least squares mean difference|Day 1||5.673|-7.391|0.7958
72563362|NCT00442546|144658170|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.111|STANDARD_ERROR_OF_MEAN|3.322||0.9733||95.0|-6.436|6.659|||ANOVA||Mean difference (final values) = Least squares mean difference|Day 1||6.659|-6.436|0.9733
72370550|NCT00488683|144251633|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|0.83||||0.001||95.0|||||Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccination and hSBA titers rise from pre-booster to one month after booster vaccination for the serogroup A||||0.001
72620974|NCT00655356|144772887|SUPERIORITY_OR_OTHER||||||<|1e-05|TWO_SIDED|95.0|||||Cochran-Mantel-Haenszel|Stratified by combined treatment site.||A 5% level of significance was used as the threshold for determination of statistical significance, and all tests were two-tailed. the effect size and associated 95% confidence interval (CI) are provided for all comparative efficacy outcomes. Primary analysis of the two co-primary efficacy endpoints and the secondary efficacy endpoints were performed on the ITT population.||||<.00001
72460362|NCT00321672|144443956|SUPERIORITY_OR_OTHER|||||||0.0662||95.0||||All statistical tests of hypotheses were two-sided and at the 5% level of significance.|Regression, Logistic|A logistic regression analysis, with the Baseline NPRS score and gender as covariates, was performed.||"The null hypothesis was: There is no difference between the total Control and total NGX-4010 group in the Proportion of Subjects Reaching 30% Decrease in Their Mean Average Pain for the Past 24 Hours NPRS Score From Baseline During Weeks 2 to 12."||||0.0662
72460363|NCT00321672|144443956|SUPERIORITY_OR_OTHER|||||||0.5582||95.0||||All statistical tests of hypotheses were two-sided and at the 5% level of significance. No multiplicity adjustments were made.|Regression, Logistic|A logistic regression analysis, with the Baseline NPRS score and gender as covariates, was performed.||||||0.5582
72460364|NCT00321672|144443956|SUPERIORITY_OR_OTHER|||||||0.0553||95.0||||All statistical tests of hypotheses were two-sided and at the 5% level of significance. No multiplicity adjustments were made.|Regression, Logistic|A logistic regression analysis, with the Baseline NPRS score and gender as covariates, was performed.||||||0.0553
72460365|NCT03163472|144443957|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
72460366|NCT03163472|144443958|OTHER|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||||||0.001
72460367|NCT03163472|144443959|OTHER|||||||0.022|||||||Wilcoxon (Mann-Whitney)|||||||0.022
72460368|NCT03163472|144443960|OTHER|||||||0.011|||||||Wilcoxon (Mann-Whitney)|||||||0.011
72460369|NCT02680145|144443980|SUPERIORITY|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||Baseline score vs Follow-up score||||0.001
72460370|NCT02680145|144443981|SUPERIORITY|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||Baseline score vs Follow-up score||||0.001
72460371|NCT02680145|144443982|SUPERIORITY|||||||0.005|||||||Wilcoxon (Mann-Whitney)|||Baseline score vs Follow-up score||||0.005
72460372|NCT01542502|144443983|SUPERIORITY_OR_OTHER|||||||0.009|TWO_SIDED||||||ANOVA|||||||0.009
72460373|NCT01542502|144443984|SUPERIORITY_OR_OTHER|||||||0.87|||||||ANOVA|||||||0.87
72460374|NCT02168855|144443990|SUPERIORITY||Odds Ratio (OR)|1.39||||0.46|TWO_SIDED|95.0|0.58|3.29|||Regression, Logistic|This is a logistic regression model of the active versus placebo arm, while controlling for age and cigarettes smoked per day at enrollment.|The active arm is the numerator and the placebo arm is the denominator of the odds ratio|||3.29|0.58|0.46
72460375|NCT02168855|144443991|SUPERIORITY||Odds Ratio (OR)|1.9|||<|0.0001|TWO_SIDED|95.0|1.83|1.98|||Mixed Models Analysis|Includes random subject intercept effect|Reflects an odds ratio relative to a 10-unit increase in craving. Temptations are the numerator and background is the denominator.|||1.98|1.83|<0.0001
72460376|NCT02168855|144443992|SUPERIORITY||Odds Ratio (OR)|1.66|||<|0.0001|TWO_SIDED|95.0|1.51|1.83|||Mixed Models Analysis|Includes random subject intercept effect|Reflects an odds ratio relative to a 10-unit increase in negative affect T-score. Temptations are the numerator and background is the denominator.|||1.83|1.51|<0.0001
72460377|NCT02168855|144443993|SUPERIORITY||Odds Ratio (OR)|0.18|||<|0.0001|TWO_SIDED|95.0|0.14|0.21|||Regression, Logistic|Includes random subject intercept effect|Odds ratio where temptations are the numerator and background is the denominator, that no smoking cues were seen.|||0.21|0.14|<0.0001
72460378|NCT02168855|144443994|SUPERIORITY||Odds Ratio (OR)|0.19|||<|0.0001|TWO_SIDED|95.0|0.15|0.23|||Regression, Logistic||Odds ratio where temptations are the numerator and background is the denominator, that no other people were seen smoking nearby.|||0.23|0.15|<0.0001
72460379|NCT03000829|144444026|SUPERIORITY|||||||0.41|||||||t-test, 2 sided|||||||0.41
72460380|NCT03000829|144444027|SUPERIORITY|||||||0.86|||||||t-test, 2 sided|||||||0.86
72460381|NCT03000829|144444028|SUPERIORITY|||||||0.97|||||||t-test, 2 sided|||||||0.97
72501246|NCT00733902|144532352|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.37|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.56|-0.17|||ANCOVA|||ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.17|-0.56|<0.001
72501247|NCT00733902|144532352|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.51|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.7|-0.31|||ANCOVA|||ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.31|-0.70|<0.001
72501248|NCT00733902|144532353|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.27|STANDARD_ERROR_OF_MEAN|0.27||0.326|TWO_SIDED|95.0|-0.8|0.27|||ANCOVA|||Change at Week 2: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||0.27|-0.80|0.326
72501249|NCT00733902|144532353|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|0.27||0.275|TWO_SIDED|95.0|-0.24|0.83|||ANCOVA|||Change at Week 2: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||0.83|-0.24|0.275
72501250|NCT00733902|144532353|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.03|STANDARD_ERROR_OF_MEAN|0.27||0.918|TWO_SIDED|95.0|-0.51|0.56|||ANCOVA|||Change at Week 2: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||0.56|-0.51|0.918
72460382|NCT03000829|144444029|SUPERIORITY|||||||0.87|||||||t-test, 2 sided|||||||0.87
72460383|NCT03000829|144444030|SUPERIORITY|||||||0.63|||||||t-test, 2 sided|||||||0.63
72501251|NCT00733902|144532353|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.93|STANDARD_ERROR_OF_MEAN|0.27|<|0.001|TWO_SIDED|95.0|-1.47|-0.4|||ANCOVA|||Change at Week 4: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.40|-1.47|<0.001
72460384|NCT03000829|144444031|SUPERIORITY|||||||0.62|||||||t-test, 2 sided|||||||0.62
72460385|NCT03000829|144444032|SUPERIORITY|||||||0.84|||||||t-test, 2 sided|||||||0.84
72460386|NCT03000829|144444033|SUPERIORITY|||||||0.4|||||||t-test, 2 sided|||||||0.40
72460387|NCT03000829|144444036|SUPERIORITY|||||||0.92|||||||Mixed Models Analysis|||||||0.92
72460388|NCT00635609|144444093|SUPERIORITY_OR_OTHER|||||||0.765||95.0|||||Cochran-Mantel-Haenszel|Stratified on investigational site.||Study not adequately powered to detect differences in efficacy outcomes. Results to provide estimates of safety and efficacy outcomes.||||0.765
72460389|NCT00635609|144444094|SUPERIORITY_OR_OTHER|||||||0.29||95.0|||||Cochran-Mantel-Haenszel|Stratified on investigational site.||Study not adequately powered to detect differences in efficacy outcomes. Results to provide estimates of safety and efficacy outcomes.||||0.290
72392570|NCT02155608|144292445|SUPERIORITY|||||||0.21||||||p \< .05 for statistical significance.|Mixed Models Analysis|Group: F = 1.62, df = 1/128.||Phase 1a: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects.||||.21
72460390|NCT00635609|144444095|SUPERIORITY_OR_OTHER|||||||0.033||95.0|||||Cochran-Mantel-Haenszel|Stratified on investigational site||Study not adequately powered to detect differences in efficacy outcomes. Results to provide estimates of safety and efficacy outcomes.||||0.033
72460391|NCT04448561|144444114|OTHER||Geometric Least square (LS) mean ratio|100.64|||||TWO_SIDED|90.0|98.37|102.96|||||Assessment based on analysis of variance performed on natural log-transformed parameters with treatment as fixed effect and participant as random effect. Ratios and confidence limits: transformed back to raw scale and values expressed as percentages.|||102.96|98.37|
72460392|NCT04448561|144444115|OTHER||Geometric LS mean ratio|94.28|||||TWO_SIDED|90.0|89.29|99.54|||||Assessment based on analysis of variance performed on natural log-transformed parameters with treatment as fixed effect and participant as random effect. Ratios and confidence limits: transformed back to raw scale and values expressed as percentages.|||99.54|89.29|
72460393|NCT04448561|144444117|OTHER||Geometric LS mean ratio|100.79|||||TWO_SIDED|90.0|83.35|121.88|||||Assessment based on an analysis of variance performed on natural log-transformed parameters with treatment as a fixed effect. Ratios and confidence limits were transformed back to raw scale and values were expressed as percentages.|||121.88|83.35|
72460394|NCT04448561|144444118|OTHER||Geometric LS mean ratio|100.58|||||TWO_SIDED|90.0|81.35|124.36|||||Assessment based on an analysis of variance performed on natural log-transformed parameters with treatment as a fixed effect. Ratios and confidence limits were transformed back to raw scale and values were expressed as percentages.|||124.36|81.35|
72460395|NCT04448561|144444120|OTHER||Geometric LS mean ratio|89.08|||||TWO_SIDED|90.0|79.58|99.71|||||Assessment based on an analysis of variance performed on natural log-transformed parameters with treatment as a fixed effect. Ratios and confidence limits were transformed back to raw scale and values were expressed as percentages.|||99.71|79.58|
72460396|NCT04448561|144444121|OTHER||Geometric LS mean ratio|96.11|||||TWO_SIDED|90.0|83.03|111.25|||||Assessment based on an analysis of variance performed on natural log-transformed parameters with treatment as a fixed effect. Ratios and confidence limits are transformed back to raw scale and values are expressed as percentages.|||111.25|83.03|
72460397|NCT04448561|144444123|OTHER||Geometric LS mean ratio|86.54|||||TWO_SIDED|90.0|76.01|98.52|||||Assessment based on an analysis of variance performed on natural log-transformed parameters with treatment as a fixed effect. Ratios and confidence limits are transformed back to raw scale and values are expressed as percentages.|||98.52|76.01|
72460398|NCT04448561|144444124|OTHER||Geometric LS mean ratio|95.1|||||TWO_SIDED|90.0|82.52|109.6|||||Assessment based on an analysis of variance performed on natural log-transformed parameters with treatment as a fixed effect. Ratios and confidence limits were transformed back to raw scale and values were expressed as percentages.|||109.60|82.52|
72460399|NCT03050372|144444127|EQUIVALENCE|Significance level alpha=0.05; CI=95%.||||||0.329|||||||t-test, 2 sided|||"This is a crossover study; we use a paired t-test to test the hypothesis:~H0: Means of SOL for active/sham LFMS are equal; Ha: Means differ~Note this paired t-test is equivalent to:~H0: Mean changes from Baseline SOL for active/sham LFMS are equal Ha: Means differ"||||0.329
72460400|NCT03050372|144444127|EQUIVALENCE|Significance level alpha=0.05; CI=95%||||||0.321|||||||t-test, 2 sided|||"This is a crossover study; we use a paired t-test to test the hypothesis:~H0: Means of SOL for Baseline and Active LFMS are equal Ha: Means differ~Note this paired t-test is equivalent to a one-sample t-test:~H0: Mean changes from Baseline SOL for Active LFMS is equal 0 Ha: Mean is not equal zero"||||0.321
72460401|NCT03050372|144444127|EQUIVALENCE|Significance level alpha=0.05; CI=95%||||||0.687|||||||t-test, 2 sided|||"This is a crossover study; we use a paired t-test to test the hypothesis:~H0: Means of SOL for Baseline and Sham LFMS are equal Ha: Means differ~Note this paired t-test is equivalent to a one-sample t-test:~H0: Mean changes from Baseline SOL for Sham LFMS is equal 0 Ha: Mean is not equal zero"||||0.687
72460402|NCT03050372|144444128|EQUIVALENCE|Significance level alpha=0.05; CI=95%||||||0.925|||||||t-test, 2 sided|||"This is a crossover study; we use a paired t-test to test the hypothesis:~H0: Means of WASO for active/sham LFMS are equal Ha: Means differ~Note this paired t-test is equivalent to:~H0: Mean changes from Baseline WASO for active/sham LFMS are equal Ha: Means differ"||||0.925
72460403|NCT03050372|144444128|EQUIVALENCE|Significance level alpha=0.05; CI=95%||||||0.08|||||||t-test, 2 sided|||"This is a crossover study; we use a paired t-test to test the hypothesis:~H0: Means of WASO for Baseline and Active LFMS are equal Ha: Means differ~Note this paired t-test is equivalent to a one-sample t-test:~H0: Mean changes from Baseline WASO for Active LFMS is equal 0 Ha: Mean is not equal zero"||||0.08
72460404|NCT03050372|144444128|EQUIVALENCE|Significance level alpha=0.05; CI=95%||||||0.221|||||||t-test, 2 sided|||"This is a crossover study; we use a paired t-test to test the hypothesis:~H0: Means of WASO for Baseline and Sham LFMS are equal Ha: Means differ~Note this paired t-test is equivalent to a one-sample t-test:~H0: Mean changes from Baseline WASO for Sham LFMS is equal 0 Ha: Mean is not equal zero"||||0.221
72460405|NCT03050372|144444129|EQUIVALENCE|Significance level alpha=0.05; CI=95%||||||0.197|||||||t-test, 2 sided|||"This is a crossover study; we use a paired t-test to test the hypothesis:~H0: Means of TST for active/sham LFMS are equal Ha: Means differ~Note this paired t-test is equivalent to:~H0: Mean changes from Baseline TST for active/sham LFMS are equal Ha: Means differ"||||0.197
72392571|NCT02155608|144292445|SUPERIORITY|||||||0.02||||||p \< .05 for statistical significance.|Mixed Models Analysis|Time: F = 5.18, df = 1/128.||Phase 1a: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects.||||.02
72392572|NCT02155608|144292445|SUPERIORITY|||||||0.01||||||p \< .05 for statistical significance.|Mixed Models Analysis|Group \* time: F = 6.89, df = 1/128.||Phase 1a: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects.||||.01
72460406|NCT03050372|144444129|EQUIVALENCE|Significance level alpha=0.05; CI=95%||||||0.586|||||||t-test, 2 sided|||"This is a crossover study; we use a paired t-test to test the hypothesis:~H0: Means of TST for Baseline and Active LFMS are equal Ha: Means differ~Note this paired t-test is equivalent to a one-sample t-test:~H0: Mean changes from Baseline TST for Active LFMS is equal 0 Ha: Mean is not equal zero"||||0.586
72460407|NCT03050372|144444129|EQUIVALENCE|Significance level alpha=0.05; CI=95%||||||0.298|||||||t-test, 2 sided|||"This is a crossover study; we use a paired t-test to test the hypothesis:~H0: Means of TST for Baseline and Sham LFMS are equal Ha: Means differ~Note this paired t-test is equivalent to a one-sample t-test:~H0: Mean changes from Baseline TST for Sham LFMS is equal 0 Ha: Mean is not equal zero"||||0.298
72501252|NCT00733902|144532353|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.68|STANDARD_ERROR_OF_MEAN|0.27||0.013|TWO_SIDED|95.0|-1.22|-0.15|||ANCOVA|||Change at Week 4: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.15|-1.22|0.013
72501253|NCT00733902|144532353|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.03|STANDARD_ERROR_OF_MEAN|0.27|<|0.001|TWO_SIDED|95.0|-1.57|-0.49|||ANCOVA|||Change at Week 4: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.49|-1.57|<0.001
72460408|NCT03050372|144444130|EQUIVALENCE|Significance level alpha=0.05; CI=95%||||||0.424|||||||t-test, 2 sided|||"This is a crossover study; we use a paired t-test to test the hypothesis:~H0: Means of SE for active/sham LFMS are equal Ha: Means differ~Note this paired t-test is equivalent to:~H0: Mean changes from Baseline SE for active/sham LFMS are equal Ha: Means differ"||||0.424
72460409|NCT03050372|144444130|EQUIVALENCE|Significance level alpha=0.05; CI=95%||||||0.21|||||||t-test, 2 sided|||"This is a crossover study; we use a paired t-test to test the hypothesis:~H0: Means of SE for Baseline and Active LFMS are equal Ha: Means differ~Note this paired t-test is equivalent to a one-sample t-test:~H0: Mean changes from Baseline SE for Active LFMS is equal 0 Ha: Mean is not equal zero"||||0.210
72460410|NCT03050372|144444130|EQUIVALENCE|Significance level alpha=0.05; CI=95%||||||0.19|||||||t-test, 2 sided|||"This is a crossover study; we use a paired t-test to test the hypothesis:~H0: Means of SE for Baseline and Sham LFMS are equal Ha: Means differ~Note this paired t-test is equivalent to a one-sample t-test:~H0: Mean changes from Baseline SE for Sham LFMS is equal 0 Ha: Mean is not equal zero"||||0.190
72460411|NCT03050372|144444131|EQUIVALENCE|Significance level alpha=0.05; CI=95%||||||0.535|||||||t-test, 2 sided|||"This is a crossover study; we use a paired t-test to test the hypothesis:~H0: Means of EOS for active/sham LFMS are equal Ha: Means differ~Note this paired t-test is equivalent to:~H0: Mean changes from Baseline EOS for active/sham LFMS are equal Ha: Means differ"||||0.535
72460412|NCT03050372|144444131|EQUIVALENCE|Significance level alpha=0.05; CI=95%||||||0.196|||||||t-test, 2 sided|||"This is a crossover study; we use a paired t-test to test the hypothesis:~H0: Means of EOS for Baseline and Active LFMS are equal Ha: Means differ~Note this paired t-test is equivalent to a one-sample t-test:~H0: Mean changes from Baseline EOS for Active LFMS is equal 0 Ha: Mean is not equal zero"||||0.196
72460413|NCT03050372|144444131|EQUIVALENCE|Significance level alpha=0.05; CI=95%||||||0.092|||||||t-test, 2 sided|||"This is a crossover study; we use a paired t-test to test the hypothesis:~H0: Means of EOS for Baseline and Sham LFMS are equal Ha: Means differ~Note this paired t-test is equivalent to a one-sample t-test:~H0: Mean changes from Baseline EOS for Sham LFMS is equal 0 Ha: Mean is not equal zero"||||0.092
72460414|NCT03050372|144444132|EQUIVALENCE|Significance level alpha=0.05; CI=95%||||||1|||||||t-test, 2 sided|||"This is a crossover study; we use a paired t-test to test the hypothesis:~H0: Means of SQS for active/sham LFMS are equal Ha: Means differ~Note this paired t-test is equivalent to:~H0: Mean changes from Baseline SQS for active/sham LFMS are equal Ha: Means differ"||||1.00
72460415|NCT03050372|144444132|EQUIVALENCE|Significance level alpha=0.05; CI=95%||||||0.004|||||||t-test, 2 sided|||"This is a crossover study; we use a paired t-test to test the hypothesis:~H0: Means of SQS for Baseline and Active LFMS are equal Ha: Means differ~Note this paired t-test is equivalent to a one-sample t-test:~H0: Mean changes from Baseline SQS for Active LFMS is equal 0 Ha: Mean is not equal zero"||||0.004
72501254|NCT00733902|144532353|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.82|STANDARD_ERROR_OF_MEAN|0.27||0.003|TWO_SIDED|95.0|-1.36|-0.28|||ANCOVA|||Change at Week 8: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.28|-1.36|0.003
72563363|NCT00442546|144658170|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.889|STANDARD_ERROR_OF_MEAN|3.946||0.822||95.0|-6.898|8.675|||ANOVA||Mean difference (final values) = Least squares mean difference|1 hour||8.675|-6.898|0.8220
72563364|NCT00442546|144658170|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.813|STANDARD_ERROR_OF_MEAN|3.917||0.4736||95.0|-10.542|4.917|||ANOVA||Mean difference (final values) = Least squares mean difference|1 hour||4.917|-10.542|0.4736
72563365|NCT00442546|144658170|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.662|STANDARD_ERROR_OF_MEAN|4.045||0.5113||95.0|-10.639|5.316|||ANOVA||Mean difference (final values) = Least squares mean difference|2 hours||5.316|-10.639|0.5113
72563366|NCT00442546|144658170|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.365|STANDARD_ERROR_OF_MEAN|3.95||0.9266||95.0|-7.425|8.154|||ANOVA||Mean difference (final values) = Least squares mean difference|2 hours||8.154|-7.425|0.9266
72563367|NCT00442546|144658170|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.164|STANDARD_ERROR_OF_MEAN|4.347||0.9699||95.0|-8.423|8.751|||ANOVA||Mean difference (final values) = Least squares mean difference|3 hours||8.751|-8.423|0.9699
72563368|NCT00442546|144658170|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.275|STANDARD_ERROR_OF_MEAN|4.232||0.9482||95.0|-8.085|8.635|||ANOVA||Mean difference (final values) = Least squares mean difference|3 hours||8.635|-8.085|0.9482
72563369|NCT00442546|144658170|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.915|STANDARD_ERROR_OF_MEAN|7.391||0.7969||95.0|-16.842|13.012|||ANOVA||Mean difference (final values) = Least squares mean difference|4 hours||13.012|-16.842|0.7969
72563370|NCT00442546|144658170|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-10.023|STANDARD_ERROR_OF_MEAN|7.68||0.1991||95.0|-25.533|5.487|||ANOVA||Mean difference (final values) = Least squares mean difference|4 hours||5.487|-25.533|0.1991
72563371|NCT00442546|144658170|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|86.335|STANDARD_ERROR_OF_MEAN|22.737||0.0321||95.0|13.976|158.693|||ANOVA||Mean difference (final values) = Least squares mean difference|5 hours||158.693|13.976|0.0321
72563372|NCT00442546|144658170|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|44.964|STANDARD_ERROR_OF_MEAN|12.295||0.0353||95.0|5.837|84.091|||ANOVA||Mean difference (final values) = Least squares mean difference|5 hours||84.091|5.837|0.0353
72563373|NCT00442546|144658171|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.812|STANDARD_ERROR_OF_MEAN|12.055||0.5736||95.0|-30.792|17.169|||ANOVA||Mean difference (final values) = Least squares mean difference|24 hours||17.169|-30.792|0.5736
72620975|NCT00655356|144772888|SUPERIORITY_OR_OTHER|||||||0.0075|TWO_SIDED|95.0|||||Cochran-Mantel-Haenszel|Stratified by combined treatment site.||A 5% level of significance was used as the threshold for determination of statistical significance, and all tests were two-tailed. the effect size and associated 95% confidence interval (CI) are provided for all comparative efficacy outcomes. Primary analysis of the two co-primary efficacy endpoints and the secondary efficacy endpoints were performed on the ITT population.||||.0075
72392573|NCT02155608|144292445|SUPERIORITY|||||||0.15||||||p \< .05 for statistical significance.|Mixed Models Analysis|Group: F= 2.16, df = 1/59.||Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5.||||.15
72460416|NCT03050372|144444132|EQUIVALENCE|Significance level alpha=0.05; CI=95%||||||0.042|||||||t-test, 2 sided|||"This is a crossover study; we use a paired t-test to test the hypothesis:~H0: Means of SQS for Baseline and Sham LFMS are equal Ha: Means differ~Note this paired t-test is equivalent to a one-sample t-test:~H0: Mean changes from Baseline SQS for Sham LFMS is equal 0 Ha: Mean is not equal zero"||||0.042
72460417|NCT03050372|144444133|EQUIVALENCE|Significance level alpha=0.05; CI=95%||||||0.05|||||||t-test, 2 sided|||"This is a crossover study; we use a paired t-test to test the hypothesis:~H0: Means of #awake for active/sham LFMS are equal Ha: Means differ~Note this paired t-test is equivalent to:~H0: Mean changes from Baseline #awake for active/sham LFMS are equal Ha: Means differ"||||0.05
72460418|NCT03050372|144444133|EQUIVALENCE|Significance level alpha=0.05; CI=95%||||||0.379|||||||t-test, 2 sided|||"This is a crossover study; we use a paired t-test to test the hypothesis:~H0: Means of #awake for Baseline and Active LFMS are equal Ha: Means differ~Note this paired t-test is equivalent to a one-sample t-test:~H0: Mean changes from Baseline #awake for Active LFMS is equal 0 Ha: Mean is not equal zero"||||0.379
72460419|NCT03050372|144444133|EQUIVALENCE|Significance level alpha=0.05; CI=95%||||||0.284|||||||t-test, 2 sided|||"This is a crossover study; we use a paired t-test to test the hypothesis:~H0: Means of #awake for Baseline and Sham LFMS are equal Ha: Means differ~Note this paired t-test is equivalent to a one-sample t-test:~H0: Mean changes from Baseline #awake for Sham LFMS is equal 0 Ha: Mean is not equal zero"||||0.284
72460420|NCT03050372|144444134|EQUIVALENCE|Significance level alpha=0.05; CI=95%||||||0.226|||||||t-test, 2 sided|||"This is a crossover study; we use a paired t-test to test the hypothesis:~H0: Means of Fatigue for active/sham LFMS are equal Ha: Means differ~Note this paired t-test is equivalent to:~H0: Mean changes from Baseline Fatigue for active/sham LFMS are equal Ha: Means differ"||||0.226
72460421|NCT03050372|144444134|EQUIVALENCE|Significance level alpha=0.05; CI=95%||||||0.156|||||||t-test, 2 sided|||"This is a crossover study; we use a paired t-test to test the hypothesis:~H0: Means of Fatigue for Baseline and Active LFMS are equal Ha: Means differ~Note this paired t-test is equivalent to a one-sample t-test:~H0: Mean changes from Baseline Fatigue for Active LFMS is equal 0 Ha: Mean is not equal zero"||||0.156
72460422|NCT03050372|144444134|EQUIVALENCE|Significance level alpha=0.05; CI=95%||||||0.117|||||||t-test, 2 sided|||"This is a crossover study; we use a paired t-test to test the hypothesis:~H0: Means of Fatigue for Baseline and Sham LFMS are equal Ha: Means differ~Note this paired t-test is equivalent to a one-sample t-test:~H0: Mean changes from Baseline Fatigue for Sham LFMS is equal 0 Ha: Mean is not equal zero"||||0.117
72460423|NCT03050372|144444135|EQUIVALENCE|Significance level alpha=0.05; CI=95%||||||0.13|||||||t-test, 2 sided|||"This is a crossover study; we use a paired t-test to test the hypothesis:~H0: Means of Concentration for active/sham LFMS are equal Ha: Means differ~Note this paired t-test is equivalent to:~H0: Mean changes from Baseline Concentration for active/sham LFMS are equal Ha: Means differ"||||0.130
72460424|NCT03050372|144444135|EQUIVALENCE|Significance level alpha=0.05; CI=95%||||||0.249|||||||t-test, 2 sided|||"This is a crossover study; we use a paired t-test to test the hypothesis:~H0: Means of Concentration for Baseline and Active LFMS are equal Ha: Means differ~Note this paired t-test is equivalent to a one-sample t-test:~H0: Mean changes from Baseline Concentration for Active LFMS is equal 0 Ha: Mean is not equal zero"||||0.249
72563374|NCT00442546|144658171|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.991|STANDARD_ERROR_OF_MEAN|11.786||0.8003||95.0|-26.438|20.455|||ANOVA||Mean difference (final values) = Least squares mean difference|24 hours||20.455|-26.438|0.8003
72563375|NCT00442546|144658171|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.815|STANDARD_ERROR_OF_MEAN|10.371||0.5125||95.0|-27.369|13.74|||ANOVA||Mean difference (final values) = Least squares mean difference|48 hours||13.740|-27.369|0.5125
72563376|NCT00442546|144658171|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-7.294|STANDARD_ERROR_OF_MEAN|10.227||0.4773||95.0|-27.563|12.976|||ANOVA||Mean difference (final values) = Least squares mean difference|48 hours||12.976|-27.563|0.4773
72563377|NCT00442546|144658171|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-13.915|STANDARD_ERROR_OF_MEAN|11.101||0.2142||95.0|-36.055|8.226|||ANOVA||Mean difference (final values) = Least squares mean difference|72 hours||8.226|-36.055|0.2142
72563378|NCT00442546|144658171|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-11.769|STANDARD_ERROR_OF_MEAN|11.245||0.2989||95.0|-34.197|10.659|||ANOVA||Mean difference (final values) = Least squares mean difference|72 hours||10.659|-34.197|0.2989
72563379|NCT00442546|144658171|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|40.51|STANDARD_ERROR_OF_MEAN|45.612||0.3829||95.0|-53.429|134.449|||ANOVA||Mean difference (final values) = Least squares mean difference|96 hours||134.449|-53.429|0.3829
72563380|NCT00442546|144658171|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-27.25|STANDARD_ERROR_OF_MEAN|45.322||0.5531||95.0|-120.59|66.092|||ANOVA||Mean difference (final values) = Least squares mean difference|96 hours||66.092|-120.59|0.5531
72460425|NCT03050372|144444135|EQUIVALENCE|Significance level alpha=0.05; CI=95%||||||0.114|||||||t-test, 2 sided|||"This is a crossover study; we use a paired t-test to test the hypothesis:~H0: Means of Concentration for Baseline and Sham LFMS are equal Ha: Means differ~Note this paired t-test is equivalent to a one-sample t-test:~H0: Mean changes from Baseline Concentration for Sham LFMS is equal 0 Ha: Mean is not equal zero"||||0.114
72501255|NCT00733902|144532353|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.75|STANDARD_ERROR_OF_MEAN|0.27||0.006|TWO_SIDED|95.0|-1.29|-0.21|||ANCOVA|||Change at Week 8: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.21|-1.29|0.006
72501256|NCT00733902|144532353|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.33|STANDARD_ERROR_OF_MEAN|0.27|<|0.001|TWO_SIDED|95.0|-1.87|-0.79|||ANCOVA|||Change at Week 8: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.79|-1.87|<0.001
72501257|NCT00733902|144532353|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|0.29|<|0.001|TWO_SIDED|95.0|-1.68|-0.53|||ANCOVA|||Change at Week 12: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.53|-1.68|<0.001
72501258|NCT00733902|144532353|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.91|STANDARD_ERROR_OF_MEAN|0.29||0.002|TWO_SIDED|95.0|-1.48|-0.33|||ANCOVA|||Change at Week 12: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.33|-1.48|0.002
72501259|NCT00733902|144532353|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.29|STANDARD_ERROR_OF_MEAN|0.29|<|0.001|TWO_SIDED|95.0|-1.87|-0.72|||ANCOVA|||Change at Week 12: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.72|-1.87|<0.001
72501260|NCT00733902|144532353|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.68|STANDARD_ERROR_OF_MEAN|0.31||0.027|TWO_SIDED|95.0|-1.28|-0.08|||ANCOVA|||Change at Week 24: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.08|-1.28|0.027
72563381|NCT00442546|144658171|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|18.513|STANDARD_ERROR_OF_MEAN|8.491||0.2738||95.0|-89.376|126.402|||ANOVA||Mean difference (final values) = Least squares mean difference|120 hours||126.402|-89.376|0.2738
72460426|NCT05030467|144444136|SUPERIORITY||Mean Difference (Final Values)|-0.04|||||TWO_SIDED|95.0|-0.39|0.31||||||We used generalized estimating equations (GEE) to adjust for the cluster design with an identify link function and normally-distributed errors||0.31|-0.39|
72460427|NCT05030467|144444137|SUPERIORITY||Risk Ratio (RR)|1.02||||0.011|TWO_SIDED|95.0|1.0|1.03|||Regression, Logistic|||Outcomes were evaluated using generalized estimating equations with a log link and Poisson-distributed errors, adjusting for clinic-level clustering.||1.03|1.00|0.011
72460428|NCT05030467|144444140|SUPERIORITY||Mean Difference (Final Values)|-0.12||||0.383|TWO_SIDED|95.0|-0.38|0.15|||Regression, Linear|||We used generalized estimating equations (GEE) to adjust for the cluster design with an identify link function and normally-distributed errors||0.15|-0.38|0.383
72460429|NCT02169089|144444158|SUPERIORITY||Median Difference (Final Values)|-7.78||||0.0293|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.0293
72460430|NCT02169089|144444159|SUPERIORITY||Median Difference (Final Values)|-2.6|||<|0.0001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||The mean reported -3.5 and 2.1 represents the mean change between follow-up \& baseline visit. The statistical test (Mann-Whitney) reported Median difference of -2.6, which corresponds to the difference between the spironolactone and placebo group.|||||<0.0001
72460431|NCT02169089|144444160|SUPERIORITY||Median Difference (Final Values)|-40.7||||0.0189|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||The mean reported -10.3 and 17.1 represents the mean change between follow-up \& baseline visit. The statistical test (Mann-Whitney) reported Median difference of -2.6, which corresponds to the difference between the spironolactone and placebo group.|||||0.0189
72460432|NCT02169089|144444161|SUPERIORITY||Median Difference (Final Values)|-7.5||||0.1276|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||The mean reported -5.95 and 2 represents the mean change between follow-up \& baseline visit. The statistical test (Mann-Whitney) reported Median difference of -2.6, which corresponds to the difference between the spironolactone and placebo group.|||||0.1276
72563382|NCT00442546|144658171|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.644|STANDARD_ERROR_OF_MEAN|2.519||0.7987||95.0|-4.343|5.63|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2||5.630|-4.343|0.7987
72460433|NCT03320941|144444163|OTHER|Dose Finding|Mean Difference (Net)|-1.99|||||TWO_SIDED|95.0|-2.92|-0.21||||||||-0.21|-2.92|
72501261|NCT00733902|144532353|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.55|STANDARD_ERROR_OF_MEAN|0.31||0.071|TWO_SIDED|95.0|-1.15|0.05|||ANCOVA|||Change at Week 24: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||0.05|-1.15|0.071
72563383|NCT00442546|144658171|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.346|STANDARD_ERROR_OF_MEAN|2.441||0.8875||95.0|-5.177|4.485|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2||4.485|-5.177|0.8875
72563384|NCT00442546|144658171|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.537|STANDARD_ERROR_OF_MEAN|1.949||0.4319||95.0|-2.324|5.398|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4||5.398|-2.324|0.4319
72563385|NCT00442546|144658171|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.61|STANDARD_ERROR_OF_MEAN|1.935||0.407||95.0|-2.223|5.443|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4||5.443|-2.223|0.4070
72620976|NCT04349098|144772891|SUPERIORITY||Odds Ratio (OR)|0.84||||0.675|TWO_SIDED|95.0|0.39|1.79|||Cochran-Mantel-Haenszel|||||1.79|0.39|0.6750
72501262|NCT00733902|144532353|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.18|STANDARD_ERROR_OF_MEAN|0.31|<|0.001|TWO_SIDED|95.0|-1.78|-0.58|||ANCOVA|||Change at Week 24: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.58|-1.78|<0.001
72501263|NCT00733902|144532354|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.27|STANDARD_ERROR_OF_MEAN|0.27||0.326|TWO_SIDED|95.0|-0.8|0.27|||ANCOVA|||Change at Week 2: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||0.27|-0.80|0.326
72501264|NCT00733902|144532354|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|0.27||0.275|TWO_SIDED|95.0|-0.24|0.83|||ANCOVA|||Change at Week 2: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||0.83|-0.24|0.275
72620977|NCT01703221|144772904|SUPERIORITY_OR_OTHER_LEGACY||Difference in the least squares means|-0.8|||<|0.001|TWO_SIDED|95.0|-0.96|-0.63|||Constrained longitudinal analysis|Terms for treatment, prior oral antihyperglycemic agent (AHA), time, time by: treatment, prior AHA therapy status, and treatment by prior AHA status.||||-0.63|-0.96|<0.001
72392574|NCT02155608|144292445|SUPERIORITY|||||||0.05||||||p \< .05 for statistical significance.|Mixed Models Analysis|Time: F = 4.15, df = 1/55.||Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5.||||.05
72392575|NCT02155608|144292445|SUPERIORITY|||||||0.79||||||p \< .05 for statistical significance.|Mixed Models Analysis|Group \* time: F = .07, df = 1/55.||Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5.||||.79
72392576|NCT02155608|144292446|SUPERIORITY|||||||0.94||||||p \< .05 for statistical significance.|Mixed Models Analysis|Group: F = .01, df = 1/128.||Phase 1a: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects.||||.94
72460434|NCT03320941|144444163|OTHER|Dose Finding|Mean Difference (Net)|-3.0|||||TWO_SIDED|95.0|-4.15|-1.7||||||||-1.70|-4.15|
72460435|NCT03320941|144444163|OTHER|Dose Finding|Mean Difference (Net)|-3.54|||||TWO_SIDED|95.0|-4.54|-2.26||||||||-2.26|-4.54|
72460436|NCT03320941|144444163|OTHER|Dose Finding|Mean Difference (Net)|-3.91|||||TWO_SIDED|95.0|-5.01|-2.77||||||||-2.77|-5.01|
72501265|NCT00733902|144532354|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.03|STANDARD_ERROR_OF_MEAN|0.27||0.918|TWO_SIDED|95.0|-0.51|0.56|||ANCOVA|||Change at Week 2: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||0.56|-0.51|0.918
72501266|NCT00733902|144532354|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.85|STANDARD_ERROR_OF_MEAN|0.27||0.002|TWO_SIDED|95.0|-1.39|-0.32|||ANCOVA|||Change at Week 4: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.32|-1.39|0.002
72563386|NCT00442546|144658171|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.119|STANDARD_ERROR_OF_MEAN|1.641||0.4968||95.0|-4.371|2.133|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET||2.133|-4.371|0.4968
72563387|NCT00442546|144658171|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.327|STANDARD_ERROR_OF_MEAN|1.665||0.427||95.0|-1.972|4.626|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET||4.626|-1.972|0.4270
72563388|NCT00442546|144658172|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.862|STANDARD_ERROR_OF_MEAN|2.999||0.7742||95.0|-6.775|5.052|||ANOVA||Mean difference (final values) = Least squares mean difference|24 hours||5.052|-6.775|0.7742
72392577|NCT02155608|144292446|SUPERIORITY|||||||0.76||||||p \< .05 for statistical significance.|Mixed Models Analysis|Time: F = .09, df = 1/128.||Phase 1a: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects.||||.76
72392578|NCT02155608|144292446|SUPERIORITY|||||||0.39||||||p \< .05 for statistical significance.|Mixed Models Analysis|Group \* time: F = .75, df =1/128.||Phase 1a: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects.||||.39
72460437|NCT03320941|144444164|OTHER|Dose Finding|Odds Ratio (OR)|2.299||||0.39|TWO_SIDED|95.0|0.344|15.35|||Regression, Logistic|||\>= 3% Percent decrease in body weight||15.350|0.344|0.390
72460438|NCT03320941|144444164|OTHER|Dose Finding|Odds Ratio (OR)|15.78||||0.002|TWO_SIDED|95.0|2.844|87.552|||Regression, Logistic|||\>= 3% Percent decrease in body weight||87.552|2.844|0.002
72460439|NCT03320941|144444164|OTHER|Dose Finding|Odds Ratio (OR)|12.708||||0.002|TWO_SIDED|95.0|2.511|64.32|||Regression, Logistic|||\>= 3% Percent decrease in body weight||64.320|2.511|0.002
72501267|NCT00733902|144532354|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.53|STANDARD_ERROR_OF_MEAN|0.27||0.052|TWO_SIDED|95.0|-1.06|0.0|||ANCOVA|||Change at Week 4: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||0.00|-1.06|0.052
72501268|NCT00733902|144532354|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.97|STANDARD_ERROR_OF_MEAN|0.27|<|0.001|TWO_SIDED|95.0|-1.5|-0.44|||ANCOVA|||Change at Week 4: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.44|-1.50|<0.001
72563389|NCT00442546|144658172|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.006|STANDARD_ERROR_OF_MEAN|3.025||0.0996||95.0|-0.96|10.971|||ANOVA||Mean difference (final values) = Least squares mean difference|24 hours||10.971|-0.960|0.0996
72563390|NCT00442546|144658172|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.803|STANDARD_ERROR_OF_MEAN|2.79||0.7738||95.0|-4.698|6.304|||ANOVA||Mean difference (final values) = Least squares mean difference|48 hours||6.304|-4.698|0.7738
72563391|NCT00442546|144658172|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.192|STANDARD_ERROR_OF_MEAN|2.778||0.1328||95.0|-1.284|9.669|||ANOVA||Mean difference (final values) = Least squares mean difference|48 hours||9.669|-1.284|0.1328
72620978|NCT01703221|144772904|SUPERIORITY_OR_OTHER_LEGACY||Difference in the least squares means|-0.78|||<|0.001|TWO_SIDED|95.0|-0.94|-0.61|||Constrained longitudinal analysis|Terms for treatment, prior AHA therapy status (yes/no), time, and time by: treatment, prior AHA therapy status, and treatment by prior AHA status.||||-0.61|-0.94|<0.001
72392579|NCT02155608|144292446|SUPERIORITY|||||||0.09||||||p \< .05 for statistical significance.|Mixed Models Analysis|Group: F = 3.06, df = 1/59.||Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5.||||.09
72460440|NCT03320941|144444164|OTHER|Dose Finding|Odds Ratio (OR)|16.813|||<|0.001|TWO_SIDED|95.0|3.362|84.085|||Regression, Logistic|||\>= 3% Percent decrease in body weight||84.085|3.362|<0.001
72460441|NCT03320941|144444164|OTHER|Dose Finding|Odds Ratio (OR)|1.697||||0.727|TWO_SIDED|95.0|0.087|33.006|||Regression, Logistic|||\>= 3% Percent decrease in body weight (Dysglycemic)||33.006|0.087|0.727
72460442|NCT03320941|144444164|OTHER|Dose Finding|Odds Ratio (OR)|28.26||||0.012|TWO_SIDED|95.0|2.066|386.473|||Regression, Logistic|||\>= 3% Percent decrease in body weight (Dysglycemic)||386.473|2.066|0.012
72460443|NCT03320941|144444164|OTHER|Dose Finding|Odds Ratio (OR)|10.333||||0.059|TWO_SIDED|95.0|0.914|116.82|||Regression, Logistic|||\>= 3% Percent decrease in body weight (Dysglycemic)||116.820|0.914|0.059
72460444|NCT03320941|144444164|OTHER|Dose Finding|Odds Ratio (OR)|9.456||||0.062|TWO_SIDED|95.0|0.891|100.292|||Regression, Logistic|||\>= 3% Percent decrease in body weight (Dysglycemic)||100.292|0.891|0.062
72460445|NCT03320941|144444164|OTHER|Dose Finding|Odds Ratio (OR)|3.59||||0.336|TWO_SIDED|95.0|0.265|48.552|||Regression, Logistic|||\>= 3% Percent decrease in body weight (T2DM)||48.552|0.265|0.336
72460446|NCT03320941|144444164|OTHER|Dose Finding|Odds Ratio, log|9.112||||0.075|TWO_SIDED|95.0|0.799|103.872|||Regression, Logistic|||\>= 3% Percent decrease in body weight (T2DM)||103.872|0.799|0.075
72460447|NCT03320941|144444164|OTHER|Dose Finding|Odds Ratio (OR)|29.312||||0.006|TWO_SIDED|95.0|2.665|322.412|||Regression, Logistic|||\>= 3% Percent decrease in body weight (T2DM)||322.412|2.665|0.006
72460448|NCT03320941|144444164|OTHER|Dose Finding|Odds Ratio (OR)|37.949||||0.003|TWO_SIDED|95.0|3.477|414.232|||Regression, Logistic|||\>= 3% Percent decrease in body weight (T2DM)||414.232|3.477|0.003
72460449|NCT03320941|144444165|OTHER|Dose Finding|Median Difference (Final Values)|-1.84|||||TWO_SIDED|95.0|-3.56|-0.19||||||Dysglycemic||-0.19|-3.56|
72460450|NCT03320941|144444165|OTHER|Dose Finding|Mean Difference (Final Values)|-2.98|||||TWO_SIDED|95.0|-4.56|-1.46||||||Dysglycemic||-1.46|-4.56|
72460451|NCT03320941|144444165|OTHER|Dose Finding|Mean Difference (Final Values)|-3.33|||||TWO_SIDED|95.0|-4.71|-1.82||||||Dysglycemic||-1.82|-4.71|
72460452|NCT03320941|144444165|OTHER|Dose Finding|Mean Difference (Final Values)|-3.51|||||TWO_SIDED|95.0|-4.93|-1.74||||||Dysglycemic||-1.74|-4.93|
72501269|NCT00733902|144532354|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.74|STANDARD_ERROR_OF_MEAN|0.27||0.006|TWO_SIDED|95.0|-1.26|-0.21|||ANCOVA|||Change at Week 8: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.21|-1.26|0.006
72460453|NCT03320941|144444165|OTHER|Dose Finding|Mean Difference (Final Values)|-1.96|||||TWO_SIDED|95.0|-3.12|-0.15||||||T2DM||-0.15|-3.12|
72460454|NCT03320941|144444165|OTHER|Dose Finding|Mean Difference (Final Values)|-2.88|||||TWO_SIDED|95.0|-4.37|-0.61||||||T2DM||-0.61|-4.37|
72460455|NCT03320941|144444165|OTHER|Dose Finding|Mean Difference (Final Values)|-3.64|||||TWO_SIDED|95.0|-5.2|-1.52||||||T2DM||-1.52|-5.20|
72460456|NCT03320941|144444165|OTHER|Dose Finding|Median Difference (Final Values)|-4.37|||||TWO_SIDED|95.0|-5.93|-2.79||||||T2DM||-2.79|-5.93|
72460457|NCT03320941|144444166|OTHER|Dose Finding|Mean Difference (Final Values)|-1.1|STANDARD_ERROR_OF_MEAN|1.011||0.278|TWO_SIDED|95.0|-3.104|0.9|||ANCOVA|||Overall Study||0.900|-3.104|0.278
72460458|NCT03320941|144444166|OTHER|Dose Finding|Mean Difference (Final Values)|-1.26|STANDARD_ERROR_OF_MEAN|1.013||0.216|TWO_SIDED|95.0|-3.265|0.747|||ANCOVA|||Overall Study||0.747|-3.265|0.216
72501270|NCT00733902|144532354|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.76|STANDARD_ERROR_OF_MEAN|0.27||0.004|TWO_SIDED|95.0|-1.28|-0.24|||ANCOVA|||Change at Week 8: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.24|-1.28|0.004
72460459|NCT03320941|144444166|OTHER|Dose Finding|Mean Difference (Final Values)|-1.28|STANDARD_ERROR_OF_MEAN|0.902||0.158|TWO_SIDED|95.0|-3.069|0.504|||ANCOVA|||Overall Study||0.504|-3.069|0.158
72460460|NCT03320941|144444166|OTHER|Dose Finding|Mean Difference (Final Values)|-1.74|STANDARD_ERROR_OF_MEAN|0.89||0.053|TWO_SIDED|95.0|-3.401|0.022|||ANCOVA|||Overall Study||0.022|-3.401|0.053
72460461|NCT03320941|144444166|OTHER|Dose Finding|Mean Difference (Final Values)|-2.36|STANDARD_ERROR_OF_MEAN|1.534||0.13|TWO_SIDED|95.0|-5.444|0.717|||ANCOVA|||Dysglycemic||0.717|-5.444|0.130
72563392|NCT00442546|144658172|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.928|STANDARD_ERROR_OF_MEAN|3.012||0.7585||95.0|-5.027|6.882|||ANOVA||Mean difference (final values) = Least squares mean difference|72 hours||6.882|-5.027|0.7585
72563393|NCT00442546|144658172|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.946|STANDARD_ERROR_OF_MEAN|2.997||0.19||95.0|-1.979|9.871|||ANOVA||Mean difference (final values) = Least squares mean difference|72 hours||9.871|-1.979|0.1900
72563394|NCT00442546|144658172|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.43|STANDARD_ERROR_OF_MEAN|3.693||0.2365||95.0|-3.004|11.865|||ANOVA||Mean difference (final values) = Least squares mean difference|96 hours||11.865|-3.004|0.2365
72460462|NCT03320941|144444166|OTHER|Dose Finding|Mean Difference (Final Values)|-4.08|STANDARD_ERROR_OF_MEAN|1.534||0.011|TWO_SIDED|95.0|-7.156|-0.994|||ANCOVA|||Dysglycemic||-0.994|-7.156|0.011
72460463|NCT03320941|144444166|OTHER|Dose Finding|Mean Difference (Final Values)|-1.66|STANDARD_ERROR_OF_MEAN|1.325||0.215|TWO_SIDED|95.0|-4.322|0.996|||ANCOVA|||Dysglycemic||0.996|-4.322|0.215
72460464|NCT03320941|144444166|OTHER|Dose Finding|Mean Difference (Final Values)|-1.81|STANDARD_ERROR_OF_MEAN|1.346||0.184|TWO_SIDED|95.0|-4.515|0.888|||ANCOVA|||Dysglycemic||0.888|-4.515|0.184
72460465|NCT03320941|144444166|OTHER|Dose Finding|Mean Difference (Final Values)|-0.03|STANDARD_ERROR_OF_MEAN|1.292||0.982|TWO_SIDED|95.0|-2.611|2.552|||ANCOVA|||T2DM||2.552|-2.611|0.982
72460466|NCT03320941|144444166|OTHER|Dose Finding|Mean Difference (Final Values)|0.8|STANDARD_ERROR_OF_MEAN|1.304||0.544|TWO_SIDED|95.0|-1.809|3.401|||ANCOVA|||T2DM||3.401|-1.809|0.544
72460467|NCT03320941|144444166|OTHER|Dose Finding|Mean Difference (Final Values)|-0.71|STANDARD_ERROR_OF_MEAN|1.188||0.552|TWO_SIDED|95.0|-3.084|1.663|||ANCOVA|||T2DM||1.663|-3.084|0.552
72460468|NCT03320941|144444166|OTHER|Dose Finding|Mean Difference (Final Values)|-1.69|STANDARD_ERROR_OF_MEAN|1.139||0.143|TWO_SIDED|95.0|-3.964|0.588|||ANCOVA|||T2DM||0.588|-3.964|0.143
72460469|NCT03320941|144444167|OTHER|Dose Finding|Mean Difference (Final Values)|-0.206|STANDARD_ERROR_OF_MEAN|0.086||0.018|TWO_SIDED|95.0|-0.376|-0.035|||ANCOVA|||Overall Study||-0.035|-0.376|0.018
72460470|NCT03320941|144444167|OTHER|Dose Finding|Mean Difference (Final Values)|-0.276|STANDARD_ERROR_OF_MEAN|0.0863||0.002|TWO_SIDED|95.0|-0.447|-0.105|||ANCOVA|||Overall Study||-0.105|-0.447|0.002
72460471|NCT03320941|144444167|OTHER|Dose Finding|Mean Difference (Final Values)|-0.287|STANDARD_ERROR_OF_MEAN|0.076|<|0.001|TWO_SIDED|95.0|-0.437|-0.136|||ANCOVA|||Overall Study||-0.136|-0.437|<0.001
72460472|NCT03320941|144444167|OTHER|Dose Finding|Mean Difference (Final Values)|-0.338|STANDARD_ERROR_OF_MEAN|0.0747|<|0.001|TWO_SIDED|95.0|-0.486|-0.19|||ANCOVA|||Overall Study||-0.190|-0.486|<0.001
72460473|NCT03320941|144444167|OTHER|Dose Finding|Mean Difference (Final Values)|-0.089|STANDARD_ERROR_OF_MEAN|0.0775||0.258|TWO_SIDED|95.0|-0.245|0.067|||ANCOVA|||Dysglycemic||0.067|-0.245|0.258
72392580|NCT02155608|144292446|SUPERIORITY|||||||0.79||||||p \< .05 for statistical significance.|Mixed Models Analysis|Time: F = .07, df = 1/55.||Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5.||||.79
72392581|NCT02155608|144292446|SUPERIORITY|||||||0.22||||||p \< .05 for statistical significance.|Mixed Models Analysis|Group \* time: F = 1.55, df = 1/55.||Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5.||||.22
72392582|NCT02155608|144292447|SUPERIORITY|||||||0.64||||||p \< .05 for statistical significance.|Mixed Models Analysis|Group: F = .22, df = 1/128.||Phase 1a: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects.||||.64
72460474|NCT03320941|144444167|OTHER|Dose Finding|Mean Difference (Final Values)|-0.134|STANDARD_ERROR_OF_MEAN|0.0774||0.088|TWO_SIDED|95.0|-0.29|0.021|||ANCOVA|||Dysglycemic||0.021|-0.290|0.088
72460475|NCT03320941|144444167|OTHER|Dose Finding|Mean Difference (Final Values)|-0.146|STANDARD_ERROR_OF_MEAN|0.0673||0.035|TWO_SIDED|95.0|-0.282|-0.011|||ANCOVA|||Dysglycemic||-0.011|-0.282|0.035
72460476|NCT03320941|144444167|OTHER|Dose Finding|Mean Difference (Final Values)|-0.113|STANDARD_ERROR_OF_MEAN|0.0673||0.1|TWO_SIDED|95.0|-0.248|0.022|||ANCOVA|||Dysglycemic||0.022|-0.248|0.100
72460477|NCT03320941|144444167|OTHER|Dose Finding|Mean Difference (Final Values)|-0.313|STANDARD_ERROR_OF_MEAN|0.1399||0.029|TWO_SIDED|95.0|-0.592|-0.033|||ANCOVA|||T2DM||-0.033|-0.592|0.029
72460478|NCT03320941|144444167|OTHER|Dose Finding|Mean Difference (Final Values)|-0.399|STANDARD_ERROR_OF_MEAN|0.1411||0.006|TWO_SIDED|95.0|-0.681|-0.117|||ANCOVA|||T2DM||-0.117|-0.681|0.006
72460479|NCT03320941|144444167|OTHER|Dose Finding|Mean Difference (Final Values)|-0.409|STANDARD_ERROR_OF_MEAN|0.1253||0.002|TWO_SIDED|95.0|-0.66|-0.159|||ANCOVA|||T2DM||-0.159|-0.660|0.002
72460480|NCT03320941|144444167|OTHER|Dose Finding|Mean Difference (Final Values)|-0.526|STANDARD_ERROR_OF_MEAN|0.1217|<|0.001|TWO_SIDED|95.0|-0.769|-0.282|||ANCOVA|||T2DM||-0.282|-0.769|<0.001
72460481|NCT03320941|144444168|OTHER|Dose Finding|Mean Difference (Final Values)|-0.174|STANDARD_ERROR_OF_MEAN|0.2094||0.408|TWO_SIDED|95.0|-0.589|0.241|||ANCOVA|||Overall Study||0.241|-0.589|0.408
72460482|NCT03320941|144444168|OTHER|Dose Finding|Mean Difference (Final Values)|-0.505|STANDARD_ERROR_OF_MEAN|0.2115||0.018|TWO_SIDED|95.0|-0.924|-0.087|||ANCOVA|||Overall Study||-0.087|-0.924|0.018
72460483|NCT03320941|144444168|OTHER|Dose Finding|Mean Difference (Final Values)|-0.587|STANDARD_ERROR_OF_MEAN|0.1866||0.002|TWO_SIDED|95.0|-0.956|-0.217|||ANCOVA|||Overall Study||-0.217|-0.956|0.002
72460484|NCT03320941|144444168|OTHER|Dose Finding|Mean Difference (Final Values)|-0.826|STANDARD_ERROR_OF_MEAN|0.1831|<|0.001|TWO_SIDED|95.0|-1.188|-0.463|||ANCOVA|||Overall Study||-0.463|-1.188|<0.001
72460485|NCT03320941|144444168|OTHER|Dose Finding|Mean Difference (Final Values)|0.218|STANDARD_ERROR_OF_MEAN|0.2054||0.293|TWO_SIDED|95.0|-0.194|0.631|||ANCOVA|||Dysglycemic||0.631|-0.194|0.293
72460486|NCT03320941|144444168|OTHER|Dose Finding|Mean Difference (Final Values)|0.09|STANDARD_ERROR_OF_MEAN|0.2068||0.665|TWO_SIDED|95.0|-0.325|0.506|||ANCOVA|||Dysglycemic||0.506|-0.325|0.665
72460487|NCT03320941|144444168|OTHER|Dose Finding|Mean Difference (Final Values)|-0.045|STANDARD_ERROR_OF_MEAN|0.1791||0.803|TWO_SIDED|95.0|-0.405|0.315|||ANCOVA|||Dysglycemic||0.315|-0.405|0.803
72460488|NCT03320941|144444168|OTHER|Dose Finding|Mean Difference (Final Values)|-0.256|STANDARD_ERROR_OF_MEAN|0.1787||0.159|TWO_SIDED|95.0|-0.615|0.103|||ANCOVA|||Dysglycemic||0.103|-0.615|0.159
72460489|NCT03320941|144444168|OTHER|Dose Finding|Mean Difference (Final Values)|-0.527|STANDARD_ERROR_OF_MEAN|0.3249||0.11|TWO_SIDED|95.0|-1.176|0.122|||ANCOVA|||T2DM||0.122|-1.176|0.110
72460490|NCT03320941|144444168|OTHER|Dose Finding|Mean Difference (Final Values)|-1.032|STANDARD_ERROR_OF_MEAN|0.3296||0.003|TWO_SIDED|95.0|-1.691|-0.373|||ANCOVA|||T2DM||-0.373|-1.691|0.003
72460491|NCT03320941|144444168|OTHER|Dose Finding|Mean Difference (Final Values)|-1.065|STANDARD_ERROR_OF_MEAN|0.2946|<|0.001|TWO_SIDED|95.0|-1.654|-0.476|||ANCOVA|||T2DM||-0.476|-1.654|<0.001
72460492|NCT03320941|144444168|OTHER|Dose Finding|Mean Difference (Final Values)|-1.298|STANDARD_ERROR_OF_MEAN|0.2855|<|0.001|TWO_SIDED|95.0|-1.869|-0.728|||ANCOVA|||T2DM||-0.728|-1.869|<0.001
72460493|NCT03320941|144444169|OTHER|Dose Finding|Mean Difference (Final Values)|0.46|STANDARD_ERROR_OF_MEAN|2.707||0.865|TWO_SIDED|95.0|-4.898|5.822|||ANCOVA|||Overall Study||5.822|-4.898|0.865
72460494|NCT03320941|144444169|OTHER|Dose Finding|Mean Difference (Final Values)|0.24|STANDARD_ERROR_OF_MEAN|2.765||0.931|TWO_SIDED|95.0|-5.235|5.716|||ANCOVA|||Overall Study||5.716|-5.235|0.931
72460495|NCT03320941|144444169|OTHER|Dose Finding|Mean Difference (Final Values)|-1.0|STANDARD_ERROR_OF_MEAN|2.433||0.682|TWO_SIDED|95.0|-5.817|3.82|||ANCOVA|||Overall Study||3.820|-5.817|0.682
72460496|NCT03320941|144444169|OTHER|Dose Finding|Mean Difference (Final Values)|-1.58|STANDARD_ERROR_OF_MEAN|2.387||0.508|TWO_SIDED|95.0|-6.312|3.142|||ANCOVA|||Overall Study||3.142|-6.312|0.508
72460497|NCT03320941|144444169|OTHER|Dose Finding|Mean Difference (Final Values)|1.31|STANDARD_ERROR_OF_MEAN|4.206||0.757|TWO_SIDED|95.0|-7.138|9.749|||ANCOVA|||Dysglycemic||9.749|-7.138|0.757
72460498|NCT03320941|144444169|OTHER|Dose Finding|Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|4.267||0.999|TWO_SIDED|95.0|-8.571|8.563|||ANCOVA|||Dysglycemic||8.563|-8.571|0.999
72460499|NCT03320941|144444169|OTHER|Dose Finding|Mean Difference (Final Values)|3.52|STANDARD_ERROR_OF_MEAN|3.668||0.342|TWO_SIDED|95.0|-3.848|10.88|||ANCOVA|||Dysglycemic||10.880|-3.848|0.342
72460500|NCT03320941|144444169|OTHER|Dose Finding|Mean Difference (Final Values)|2.92|STANDARD_ERROR_OF_MEAN|3.673||0.43|TWO_SIDED|95.0|-4.454|10.292|||ANCOVA|||Dysglycemic||10.292|-4.454|0.430
72460501|NCT03320941|144444169|OTHER|Dose Finding|Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|3.461||0.909|TWO_SIDED|95.0|-7.312|6.52|||ANCOVA|||T2DM||6.520|-7.312|0.909
72460502|NCT03320941|144444169|OTHER|Dose Finding|Mean Difference (Final Values)|0.81|STANDARD_ERROR_OF_MEAN|3.563||0.821|TWO_SIDED|95.0|-6.311|7.93|||ANCOVA|||T2DM||7.930|-6.311|0.821
72460503|NCT03320941|144444169|OTHER|Dose Finding|Mean Difference (Final Values)|-4.87|STANDARD_ERROR_OF_MEAN|3.19||0.132|TWO_SIDED|95.0|-11.24|1.508|||ANCOVA|||T2DM||1.508|-11.240|0.132
72460504|NCT03320941|144444169|OTHER|Dose Finding|Mean Difference (Final Values)|-5.23|STANDARD_ERROR_OF_MEAN|3.07||0.093|TWO_SIDED|95.0|-11.367|0.905|||ANCOVA|||T2DM||0.905|-11.367|0.093
72460505|NCT03320941|144444170|OTHER|Dose Finding|Mean Difference (Final Values)|-0.59|STANDARD_ERROR_OF_MEAN|2.013||0.769|TWO_SIDED|95.0|-4.579|3.393|||ANCOVA|||Overall Study||3.393|-4.579|0.769
72460506|NCT03320941|144444170|OTHER|Dose Finding|Mean Difference (Final Values)|-0.42|STANDARD_ERROR_OF_MEAN|2.043||0.839|TWO_SIDED|95.0|-4.462|3.63|||ANCOVA|||Overall Study||3.630|-4.462|0.839
72460507|NCT03320941|144444170|OTHER|Dose Finding|Mean Difference (Final Values)|-1.23|STANDARD_ERROR_OF_MEAN|1.807||0.496|TWO_SIDED|95.0|-4.811|2.345|||ANCOVA|||Overall Study||2.345|-4.811|0.496
72460508|NCT03320941|144444170|OTHER|Dose Finding|Mean Difference (Final Values)|-2.11|STANDARD_ERROR_OF_MEAN|1.774||0.237|TWO_SIDED|95.0|-5.622|1.402|||ANCOVA|||Overall Study||1.402|-5.622|0.237
72460509|NCT03320941|144444170|OTHER|Dose Finding|Mean Difference (Final Values)|0.99|STANDARD_ERROR_OF_MEAN|3.2||0.758|TWO_SIDED|95.0|-5.435|7.415|||ANCOVA|||Dysglycemic||7.415|-5.435|0.758
72460510|NCT03320941|144444170|OTHER|Dose Finding|Mean Difference (Final Values)|-0.09|STANDARD_ERROR_OF_MEAN|3.23||0.978|TWO_SIDED|95.0|-6.574|6.397|||ANCOVA|||Dysglycemic||6.397|-6.574|0.978
72460511|NCT03320941|144444170|OTHER|Dose Finding|Mean Difference (Final Values)|1.84|STANDARD_ERROR_OF_MEAN|2.79||0.512|TWO_SIDED|95.0|-3.758|7.444|||ANCOVA|||Dysglycemic||7.444|-3.758|0.512
72460512|NCT03320941|144444170|OTHER|Dose Finding|Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|2.792||0.985|TWO_SIDED|95.0|-5.552|5.657|||ANCOVA|||Dysglycemic||5.657|-5.552|0.985
72460513|NCT03320941|144444170|OTHER|Dose Finding|Mean Difference (Final Values)|-2.07|STANDARD_ERROR_OF_MEAN|2.599||0.428|TWO_SIDED|95.0|-7.268|3.121|||ANCOVA|||T2DM||3.121|-7.268|0.428
72460514|NCT03320941|144444170|OTHER|Dose Finding|Mean Difference (Final Values)|-0.52|STANDARD_ERROR_OF_MEAN|2.669||0.846|TWO_SIDED|95.0|-5.853|4.812|||ANCOVA|||T2DM||4.812|-5.853|0.846
72501271|NCT00733902|144532354|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.38|STANDARD_ERROR_OF_MEAN|0.27|<|0.001|TWO_SIDED|95.0|-1.91|-0.86|||ANCOVA|||Change at Week 8: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.86|-1.91|<0.001
72501272|NCT00733902|144532354|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.96|STANDARD_ERROR_OF_MEAN|0.27|<|0.001|TWO_SIDED|95.0|-1.5|-0.43|||ANCOVA|||Change at Week 12: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.43|-1.50|<0.001
72460515|NCT03320941|144444170|OTHER|Dose Finding|Mean Difference (Final Values)|-4.05|STANDARD_ERROR_OF_MEAN|2.388||0.095|TWO_SIDED|95.0|-8.825|0.721|||ANCOVA|||T2DM||0.721|-8.825|0.095
72460516|NCT03320941|144444170|OTHER|Dose Finding|Mean Difference (Final Values)|-3.99|STANDARD_ERROR_OF_MEAN|2.31||0.089|TWO_SIDED|95.0|-8.61|0.623|||ANCOVA|||T2DM||0.623|-8.610|0.089
72460517|NCT03320941|144444171|OTHER|Dose Finding|Mean Difference (Final Values)|-15.561|STANDARD_ERROR_OF_MEAN|21.4808||0.47|TWO_SIDED|95.0|-58.106|26.985|||ANCOVA|||Overall Study||26.985|-58.106|0.470
72501273|NCT00733902|144532354|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.77|STANDARD_ERROR_OF_MEAN|0.27||0.005|TWO_SIDED|95.0|-1.3|-0.23|||ANCOVA|||Change at Week 12: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.23|-1.30|0.005
72392583|NCT02155608|144292447|SUPERIORITY|||||||0.19||||||p \< .05 for statistical significance.|Mixed Models Analysis|Time: F = 1.49, df = 1/128.||Phase 1a: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects.||||.19
72460518|NCT03320941|144444171|OTHER|Dose Finding|Mean Difference (Final Values)|-6.343|STANDARD_ERROR_OF_MEAN|21.6316||0.77|TWO_SIDED|95.0|-49.187|36.501|||ANCOVA|||Overall Study||36.501|-49.187|0.770
72392584|NCT02155608|144292447|SUPERIORITY|||||||0.22||||||p \< .05 for statistical significance.|Mixed Models Analysis|Group \* time: F = 1.49, df = 1/128.||Phase 1a: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects.||||.22
72460519|NCT03320941|144444171|OTHER|Dose Finding|Mean Difference (Final Values)|26.527|STANDARD_ERROR_OF_MEAN|19.1803||0.169|TWO_SIDED|95.0|-11.462|64.516|||ANCOVA|||Overall Study||64.516|-11.462|0.169
72460520|NCT03320941|144444171|OTHER|Dose Finding|Mean Difference (Final Values)|-12.094|STANDARD_ERROR_OF_MEAN|18.8076||0.521|TWO_SIDED|95.0|-49.345|25.157|||ANCOVA|||Overall Study||25.157|-49.345|0.521
72460521|NCT03320941|144444171|OTHER|Dose Finding|Mean Difference (Final Values)|-22.115|STANDARD_ERROR_OF_MEAN|38.7858||0.571|TWO_SIDED|95.0|-100.058|55.828|||ANCOVA|||Dysglycemic||55.828|-100.058|0.571
72501274|NCT00733902|144532354|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.22|STANDARD_ERROR_OF_MEAN|0.27|<|0.001|TWO_SIDED|95.0|-1.75|-0.69|||ANCOVA|||Change at Week 12: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.69|-1.75|<0.001
72460522|NCT03320941|144444171|OTHER|Dose Finding|Mean Difference (Final Values)|-22.948|STANDARD_ERROR_OF_MEAN|39.4994||0.564|TWO_SIDED|95.0|-102.325|56.429|||ANCOVA|||Dysglycemic||56.429|-102.325|0.564
72460523|NCT03320941|144444171|OTHER|Dose Finding|Mean Difference (Final Values)|31.322|STANDARD_ERROR_OF_MEAN|33.855||0.359|TWO_SIDED|95.0|-36.712|99.356|||ANCOVA|||Dysglycemic||99.356|-36.712|0.359
72460524|NCT03320941|144444171|OTHER|Dose Finding|Mean Difference (Final Values)|-6.901|STANDARD_ERROR_OF_MEAN|34.4309||0.842|TWO_SIDED|95.0|-76.093|62.29|||ANCOVA|||Dysglycemic||62.290|-76.093|0.842
72460525|NCT03320941|144444171|OTHER|Dose Finding|Mean Difference (Final Values)|-12.79|STANDARD_ERROR_OF_MEAN|24.3259||0.601|TWO_SIDED|95.0|-61.417|35.836|||ANCOVA|||T2DM||35.836|-61.417|0.601
72460526|NCT03320941|144444171|OTHER|Dose Finding|Mean Difference (Final Values)|9.302|STANDARD_ERROR_OF_MEAN|24.422||0.705|TWO_SIDED|95.0|-39.517|58.121|||ANCOVA|||T2DM||58.121|-39.517|0.705
72460527|NCT03320941|144444171|OTHER|Dose Finding|Mean Difference (Final Values)|20.94|STANDARD_ERROR_OF_MEAN|22.0444||0.346|TWO_SIDED|95.0|-23.126|65.007|||ANCOVA|||T2DM||65.007|-23.126|0.346
72460528|NCT03320941|144444171|OTHER|Dose Finding|Mean Difference (Final Values)|-13.863|STANDARD_ERROR_OF_MEAN|21.2205||0.516|TWO_SIDED|95.0|-56.283|28.556|||ANCOVA|||T2DM||28.556|-56.283|0.516
72460529|NCT03320941|144444172|OTHER|Dose Finding|Mean Difference (Final Values)|0.955|STANDARD_ERROR_OF_MEAN|3.605||0.792|TWO_SIDED|95.0|-6.185|8.095|||ANCOVA|||Overall Study||8.095|-6.185|0.792
72460530|NCT03320941|144444172|OTHER|Dose Finding|Mean Difference (Final Values)|-0.739|STANDARD_ERROR_OF_MEAN|3.7167||0.843|TWO_SIDED|95.0|-8.1|6.623|||ANCOVA|||Overall Study||6.623|-8.100|0.843
72501275|NCT00733902|144532354|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.53|STANDARD_ERROR_OF_MEAN|0.28||0.061|TWO_SIDED|95.0|-1.07|0.02|||ANCOVA|||Change at Week 16: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||0.02|-1.07|0.061
72501276|NCT00733902|144532354|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.65|STANDARD_ERROR_OF_MEAN|0.28||0.021|TWO_SIDED|95.0|-1.2|-0.1|||ANCOVA|||Change at Week 16: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.10|-1.20|0.021
72501277|NCT00733902|144532354|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.3|STANDARD_ERROR_OF_MEAN|0.28|<|0.001|TWO_SIDED|95.0|-1.85|-0.76|||ANCOVA|||Change at Week 16: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.76|-1.85|<0.001
72501278|NCT00733902|144532354|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.39|STANDARD_ERROR_OF_MEAN|0.28||0.166|TWO_SIDED|95.0|-0.95|0.16|||ANCOVA|||Change at Week 24: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||0.16|-0.95|0.166
72501279|NCT00733902|144532354|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.39|STANDARD_ERROR_OF_MEAN|0.28||0.167|TWO_SIDED|95.0|-0.95|0.16|||ANOVA|||Change at Week 24: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||0.16|-0.95|0.167
72501280|NCT00733902|144532354|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|0.28|<|0.001|TWO_SIDED|95.0|-1.75|-0.64|||ANCOVA|||Change at Week 24: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.64|-1.75|<0.001
72501281|NCT00733902|144532355|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.54|STANDARD_ERROR_OF_MEAN|0.27||0.044|TWO_SIDED|95.0|-1.07|-0.02|||ANCOVA|||Change at Week 2: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.02|-1.07|0.044
72501282|NCT00733902|144532355|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.27||0.875|TWO_SIDED|95.0|-0.57|0.48|||ANCOVA|||Change at Week 2: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||0.48|-0.57|0.875
72563395|NCT00442546|144658172|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.306|STANDARD_ERROR_OF_MEAN|3.73||0.1616||95.0|-2.202|12.814|||ANOVA||Mean difference (final values) = Least squares mean difference|96 hours||12.814|-2.202|0.1616
72460531|NCT03320941|144444172|OTHER|Dose Finding|Mean Difference (Final Values)|3.128|STANDARD_ERROR_OF_MEAN|3.2564||0.339|TWO_SIDED|95.0|-3.322|9.578|||ANCOVA|||Overall Study||9.578|-3.322|0.339
72460532|NCT03320941|144444172|OTHER|Dose Finding|Mean Difference (Final Values)|2.546|STANDARD_ERROR_OF_MEAN|3.1859||0.426|TWO_SIDED|95.0|-3.764|8.856|||ANCOVA|||Overall Study||8.856|-3.764|0.426
72501283|NCT00733902|144532355|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.27||0.129|TWO_SIDED|95.0|-0.93|0.12|||ANCOVA|||Change at Week 2: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||0.12|-0.93|0.129
72501284|NCT00733902|144532355|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.98|STANDARD_ERROR_OF_MEAN|0.27|<|0.001|TWO_SIDED|95.0|-1.51|-0.45|||ANCOVA|||Change at Week 4: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.45|-1.51|<0.001
72501285|NCT00733902|144532355|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.85|STANDARD_ERROR_OF_MEAN|0.27||0.002|TWO_SIDED|95.0|-1.38|-0.32|||ANCOVA|||Change at Week 4: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.32|-1.38|0.002
72501286|NCT00733902|144532355|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.23|STANDARD_ERROR_OF_MEAN|0.27|<|0.001|TWO_SIDED|95.0|-1.76|-0.7|||ANCOVA|||Change at Week 4: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.70|-1.76|<0.001
72460533|NCT03320941|144444172|OTHER|Dose Finding|Mean Difference (Final Values)|0.504|STANDARD_ERROR_OF_MEAN|5.8734||0.932|TWO_SIDED|95.0|-11.299|12.307|||ANCOVA|||Dysglycemic||12.307|-11.299|0.932
72460534|NCT03320941|144444172|OTHER|Dose Finding|Mean Difference (Final Values)|-2.458|STANDARD_ERROR_OF_MEAN|6.3493||0.7|TWO_SIDED|95.0|-15.217|10.302|||ANCOVA|||Dysglycemic||10.302|-15.217|0.700
72460535|NCT03320941|144444172|OTHER|Dose Finding|Mean Difference (Final Values)|7.832|STANDARD_ERROR_OF_MEAN|5.0946||0.131|TWO_SIDED|95.0|-2.406|18.07|||ANCOVA|||Dysglycemic||18.070|-2.406|0.131
72501287|NCT00733902|144532355|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.83|STANDARD_ERROR_OF_MEAN|0.27||0.002|TWO_SIDED|95.0|-1.35|-0.3|||ANCOVA|||Week 8: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.30|-1.35|0.002
72501288|NCT00733902|144532355|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.87|STANDARD_ERROR_OF_MEAN|0.27||0.001|TWO_SIDED|95.0|-1.39|-0.34|||ANCOVA|||Change at Week 8: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.34|-1.39|0.001
72563396|NCT00442546|144658172|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.071|STANDARD_ERROR_OF_MEAN|6.911||0.8819||95.0|-17.98|15.838|||ANOVA||Mean difference (final values) = Least squares mean difference|120 hours||15.838|-17.98|0.8819
72563397|NCT00442546|144658172|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-9.071|STANDARD_ERROR_OF_MEAN|11.7||0.4676||95.0|-37.7|19.558|||ANOVA||Mean difference (final values) = Least squares mean difference|120 hours||19.558|-37.70|0.4676
72563398|NCT00442546|144658172|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.925|STANDARD_ERROR_OF_MEAN|2.195||0.3813||95.0|-2.403|6.254|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2||6.254|-2.403|0.3813
72460536|NCT03320941|144444172|OTHER|Dose Finding|Mean Difference (Final Values)|1.825|STANDARD_ERROR_OF_MEAN|5.197||0.727|TWO_SIDED|95.0|-8.619|12.269|||ANCOVA|||Dysglycemic||12.269|-8.619|0.727
72392585|NCT02155608|144292447|SUPERIORITY|||||||0.05||||||p \< .05 for statistical significance.|Mixed Models Analysis|Group: F = 3.95, df = 1/59.||Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5.||||.05
72501289|NCT00733902|144532355|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.42|STANDARD_ERROR_OF_MEAN|0.27|<|0.001|TWO_SIDED|95.0|-1.94|-0.9|||ANCOVA|||Change at Week 8: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.90|-1.94|<0.001
72501290|NCT00733902|144532355|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.14|STANDARD_ERROR_OF_MEAN|0.29|<|0.001|TWO_SIDED|95.0|-1.7|-0.58|||ANCOVA|||Change at Week 12: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.58|-1.70|<0.001
72501291|NCT00733902|144532355|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.01|STANDARD_ERROR_OF_MEAN|0.29|<|0.001|TWO_SIDED|95.0|-1.57|-0.45|||ANCOVA|||Change at Week 12: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.45|-1.57|<0.001
72501292|NCT00733902|144532355|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.35|STANDARD_ERROR_OF_MEAN|0.28|<|0.001|TWO_SIDED|95.0|-1.91|-0.79|||ANCOVA|||Change at Week 12: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.79|-1.91|<0.001
72501293|NCT00733902|144532355|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.68|STANDARD_ERROR_OF_MEAN|0.29||0.021|TWO_SIDED|95.0|-1.26|-0.1|||ANCOVA|||Change at Week 24: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.10|-1.26|0.021
72563399|NCT00442546|144658172|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.341|STANDARD_ERROR_OF_MEAN|2.236||0.2966||95.0|-2.07|6.751|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2||6.751|-2.070|0.2966
72392586|NCT02155608|144292447|SUPERIORITY|||||||0.96||||||p \< .05 for statistical significance.|Mixed Models Analysis|Time: F = 0.00, df = 1/55.||Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5.||||.96
72392587|NCT02155608|144292447|SUPERIORITY|||||||0.92||||||p \< .05 for statistical significance.|Mixed Models Analysis|Group \* time: F = .01, df = 1/55.||Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5.||||.92
72392588|NCT02155608|144292448|SUPERIORITY|||||||0.79||||||p \< .05 for statistical significance.|Mixed Models Analysis|Group: F = .07, df = 1/128.||Phase 1a: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects.||||.79
72392589|NCT02155608|144292448|SUPERIORITY|||||||0.3||||||p \< .05 for statistical significance.|Mixed Models Analysis|Time: F = 1.10, df = 1/128.||Phase 1a: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects.||||.30
72392590|NCT02155608|144292448|SUPERIORITY|||||||0.03||||||p \< .05 for statistical significance.|Mixed Models Analysis|Group \* time: F = 4.61, df = 1/128.||Phase 1a: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects.||||.03
72392591|NCT02155608|144292448|SUPERIORITY|||||||0.14||||||p \< .05 for statistical significance.|Mixed Models Analysis|Group: F = 2.24, df = 1/59.||Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5.||||.14
72392592|NCT02155608|144292448|SUPERIORITY|||||||0.82||||||p \< .05 for statistical significance.|Mixed Models Analysis|Time: F = .05, df = 1/55.||Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5.||||.82
72392593|NCT02155608|144292448|SUPERIORITY|||||||0.07||||||p \< .05 for statistical significance.|Mixed Models Analysis|Group \* time: F = 3.35, df = 1/55.||Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5.||||.07
72392594|NCT02155608|144292449|SUPERIORITY|||||||0.55|||||||Mixed Models Analysis|Group: F = .36, df = 1/52||Phase 1a: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects.||||.55
72392595|NCT02155608|144292449|SUPERIORITY|||||||0.34|||||||Mixed Models Analysis|Time: F = .09, df = 1/52||Phase 1a: Outcomes were fitted via a mixed model with group, time, and group-by-time interactions to test for treatment effects.||||.34
72392596|NCT02155608|144292449|SUPERIORITY|||||||0.81|||||||Mixed Models Analysis|Group \* time: F = .06, df = 1/52||Phase 1 a: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interaction to test for treatment effects.||||.81
72392597|NCT02155608|144292449|SUPERIORITY|||||||0.83|||||||Mixed Models Analysis|Group: F = .05, df = 1/59||Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5.||||.83
72392598|NCT02155608|144292449|SUPERIORITY|||||||0.04|||||||Mixed Models Analysis|Time: F = 4.52, df = 1/43||Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5.||||.04
72392599|NCT02155608|144292449|SUPERIORITY|||||||0.73|||||||Mixed Models Analysis|Group \* time: F = .12, df = 1/43||Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5.||||.73
72392600|NCT02155608|144292450|SUPERIORITY|||||||0.21|||||||Mixed Models Analysis|Group: F = 1.62, df = 1/58.||Phase 1a: Outcomes were fitted via a mixed effects model with group-by-time interactions to test for treatment effects using a piecewise linear time trend. This was parametrized in the model as a standard linear viable, time (ranging from baseline to 4 weeks) and a second variable, time2. defined as 0 at baseline and time past week 1 for subsequent weeks. The time 2 coefficient represents the change in slope after the initial week.||||.21
72392601|NCT02155608|144292450|SUPERIORITY|||||||0.39|||||||Mixed Models Analysis|Time: F = .74, df = 1/58.||Phase 1a: Outcomes were fitted via a mixed effects model with group-by-time interactions to test for treatment effects using a piecewise linear time trend. This was parametrized in the model as a standard linear viable, time (ranging from baseline to 4 weeks) and a second variable, time2. defined as 0 at baseline and time past week 1 for subsequent weeks. The time 2 coefficient represents the change in slope after the initial week.||||.39
72392602|NCT02155608|144292450|SUPERIORITY|||||||0.18|||||||Mixed Models Analysis|Time2: F = 1.88, df = 1/58.||Phase 1a: Outcomes were fitted via a mixed effects model with group-by-time interactions to test for treatment effects using a piecewise linear time trend. This was parametrized in the model as a standard linear viable, time (ranging from baseline to 4 weeks) and a second variable, time2. defined as 0 at baseline and time past week 1 for subsequent weeks. The time 2 coefficient represents the change in slope after the initial week.||||.18
72392603|NCT02155608|144292450|SUPERIORITY|||||||0.22|||||||Mixed Models Analysis|Group \* time: F = 1.56; df = 1/58.||Phase 1a: Outcomes were fitted via a mixed effects model with group-by-time interactions to test for treatment effects using a piecewise linear time trend. This was parametrized in the model as a standard linear viable, time (ranging from baseline to 4 weeks) and a second variable, time2. defined as 0 at baseline and time past week 1 for subsequent weeks. The time 2 coefficient represents the change in slope after the initial week.||||.22
72392604|NCT02155608|144292450|SUPERIORITY|||||||0.21|||||||Mixed Models Analysis|Group: F = 1.72, df = 1/12.||Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5.||||.21
72501294|NCT00733902|144532355|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.64|STANDARD_ERROR_OF_MEAN|0.29||0.029|TWO_SIDED|95.0|-1.22|-0.07|||ANCOVA|||Change at Week 24: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.07|-1.22|0.029
72392605|NCT02155608|144292450|SUPERIORITY|||||||1||||||Test not valid due to insufficient data.|Mixed Models Analysis|Time: F = 0.00, df = 1/0.||Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5.||||1
72392606|NCT02155608|144292450|SUPERIORITY|||||||1||||||Test not valid due to insufficient data.|Mixed Models Analysis|Group \* time: F = .87, df = 1/0.||Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5.||||1
72460537|NCT03320941|144444172|OTHER|Dose Finding|Mean Difference (Final Values)|0.828|STANDARD_ERROR_OF_MEAN|4.5876||0.857|TWO_SIDED|95.0|-8.342|9.999|||ANCOVA|||T2DM||9.999|-8.342|0.857
72460538|NCT03320941|144444172|OTHER|Dose Finding|Mean Difference (Final Values)|-0.696|STANDARD_ERROR_OF_MEAN|4.7173||0.883|TWO_SIDED|95.0|-10.126|8.734|||ANCOVA|||T2DM||8.734|-10.126|0.883
72460539|NCT03320941|144444172|OTHER|Dose Finding|Mean Difference (Final Values)|-0.975|STANDARD_ERROR_OF_MEAN|4.2883||0.821|TWO_SIDED|95.0|-9.547|7.597|||ANCOVA|||T2DM||7.597|-9.547|0.821
72460540|NCT03320941|144444172|OTHER|Dose Finding|Mean Difference (Final Values)|2.488|STANDARD_ERROR_OF_MEAN|4.1111||0.547|TWO_SIDED|95.0|-5.73|10.706|||ANCOVA|||T2DM||10.706|-5.730|0.547
72501295|NCT00733902|144532355|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|0.29|<|0.001|TWO_SIDED|95.0|-1.78|-0.62|||ANCOVA|||Change at Week 24: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.62|-1.78|<0.001
72501296|NCT00733902|144532356|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.54|STANDARD_ERROR_OF_MEAN|0.27||0.044|TWO_SIDED|95.0|-1.07|-0.02|||ANCOVA|||Change at Week 2: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.02|-1.07|0.044
72501297|NCT00733902|144532356|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.27||0.875|TWO_SIDED|95.0|-0.57|0.48|||ANCOVA|||Change at Week 2: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||0.48|-0.57|0.875
72501298|NCT00733902|144532356|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.27||0.129|TWO_SIDED|95.0|-0.93|0.12|||ANCOVA|||Change at Week 2: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||0.12|-0.93|0.129
72501299|NCT00733902|144532356|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.94|STANDARD_ERROR_OF_MEAN|0.27|<|0.001|TWO_SIDED|95.0|-1.46|-0.41|||ANCOVA|||Change at Week 4: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.41|-1.46|<0.001
72501300|NCT00733902|144532356|SUPERIORITY_OR_OTHER_LEGACY||L Mean Difference|-0.76|STANDARD_ERROR_OF_MEAN|0.27||0.004|TWO_SIDED|95.0|-1.28|-0.24|||ANCOVA|||Change at Week 4: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.24|-1.28|0.004
72501301|NCT00733902|144532356|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.19|STANDARD_ERROR_OF_MEAN|0.26|<|0.001|TWO_SIDED|95.0|-1.71|-0.67|||ANCOVA|||Change at Week 4: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.67|-1.71|<0.001
72501302|NCT00733902|144532356|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.82|STANDARD_ERROR_OF_MEAN|0.26||0.002|TWO_SIDED|95.0|-1.33|-0.3|||ANCOVA|||Change at Week 8: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.30|-1.33|0.002
72501303|NCT00733902|144532356|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.95|STANDARD_ERROR_OF_MEAN|0.26|<|0.001|TWO_SIDED|95.0|-1.46|-0.43|||ANCOVA|||Change at Week 8: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.43|-1.46|<0.001
72501304|NCT00733902|144532356|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.53|STANDARD_ERROR_OF_MEAN|0.26|<|0.001|TWO_SIDED|95.0|-2.04|-1.02|||ANCOVA|||Change at Week 8: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-1.02|-2.04|<0.001
72460541|NCT03320941|144444173|OTHER|Dose Finding|Mean Difference (Final Values)|4.954|STANDARD_ERROR_OF_MEAN|3.4006||0.148|TWO_SIDED|95.0|-1.781|11.689|||ANCOVA|||Overall Study||11.689|-1.781|0.148
72501305|NCT00733902|144532356|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.03|STANDARD_ERROR_OF_MEAN|0.27|<|0.001|TWO_SIDED|95.0|-1.56|-0.51|||ANCOVA|||Change at Week 12: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.51|-1.56|<0.001
72501306|NCT00733902|144532356|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.99|STANDARD_ERROR_OF_MEAN|0.27|<|0.001|TWO_SIDED|95.0|-1.52|-0.46|||ANCOVA|||Change at Week 12: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.46|-1.52|<0.001
72501307|NCT00733902|144532356|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.37|STANDARD_ERROR_OF_MEAN|0.27|<|0.001|TWO_SIDED|95.0|-1.9|-0.85|||ANCOVA|||Change at Week 12: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.85|-1.90|<0.001
72501308|NCT00733902|144532356|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.59|STANDARD_ERROR_OF_MEAN|0.27||0.03|TWO_SIDED|95.0|-1.12|-0.06|||ANCOVA|||Change at Week 16: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.06|-1.12|0.030
72501309|NCT00733902|144532356|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.86|STANDARD_ERROR_OF_MEAN|0.27||0.002|TWO_SIDED|95.0|-1.39|-0.32|||ANCOVA|||Change at Week 16: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.32|-1.39|0.002
72501310|NCT00733902|144532356|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.43|STANDARD_ERROR_OF_MEAN|0.27|<|0.001|TWO_SIDED|95.0|-1.96|-0.9|||ANCOVA|||Change at Week 16: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.90|-1.96|<0.001
72501311|NCT00733902|144532356|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.48|STANDARD_ERROR_OF_MEAN|0.28||0.085|TWO_SIDED|95.0|-1.03|0.07|||ANCOVA|||Change at Week 24: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||0.07|-1.03|0.085
72501312|NCT00733902|144532356|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.63|STANDARD_ERROR_OF_MEAN|0.28||0.026|TWO_SIDED|95.0|-1.18|-0.08|||ANCOVA|||Change at Week 24: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.08|-1.18|0.026
72563400|NCT00442546|144658172|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.962|STANDARD_ERROR_OF_MEAN|2.576||0.4474||95.0|-3.122|7.046|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4||7.046|-3.122|0.4474
72460542|NCT03320941|144444173|OTHER|Dose Finding|Mean Difference (Final Values)|0.993|STANDARD_ERROR_OF_MEAN|3.4645||0.775|TWO_SIDED|95.0|-5.869|7.855|||ANCOVA|||Overall Study||7.855|-5.869|0.775
72460543|NCT03320941|144444173|OTHER|Dose Finding|Mean Difference (Final Values)|-1.799|STANDARD_ERROR_OF_MEAN|3.0432||0.556|TWO_SIDED|95.0|-7.826|4.229|||ANCOVA|||Overall Study||4.229|-7.826|0.556
72392607|NCT00903695|144292458|SUPERIORITY_OR_OTHER|||||||0.8133||||||a priori threshold for statistical significance = 0.01 (multiple comparisons)|ANOVA|"DF = 6~ANOVA calculation: F-ratio = 0.06, t-test = -0.25."||ANOVA used to detect significant difference in test scores between baseline and end assessments, by study arm (nutriceutical vs placebo).||||0.8133
72392608|NCT00903695|144292459|SUPERIORITY_OR_OTHER|||||||0.31||||||a priori threshold for statistical sginficance = 0.01 (multiple comparisons)|ANOVA|"DF = 6~ANOVA calculation: F-ratio=1.22, t-test=1.1"||ANOVA used to detect significant difference in test scores between baseline and end assessments, by study arm (nutriceutical vs placebo).||||0.31
72460544|NCT03320941|144444173|OTHER|Dose Finding|Mean Difference (Final Values)|3.566|STANDARD_ERROR_OF_MEAN|3.0079||0.238|TWO_SIDED|95.0|-2.391|9.524|||ANCOVA|||Overall Study||9.524|-2.391|0.238
72460545|NCT03320941|144444173|OTHER|Dose Finding|Mean Difference (Final Values)|3.811|STANDARD_ERROR_OF_MEAN|5.4552||0.488|TWO_SIDED|95.0|-7.152|14.774|||ANCOVA|||Dysglycemic||14.774|-7.152|0.488
72460546|NCT03320941|144444173|OTHER|Dose Finding|Mean Difference (Final Values)|4.659|STANDARD_ERROR_OF_MEAN|5.4845||0.4|TWO_SIDED|95.0|-6.363|15.68|||ANCOVA|||Dysglycemic||15.680|-6.363|0.400
72460547|NCT03320941|144444173|OTHER|Dose Finding|Mean Difference (Final Values)|1.05|STANDARD_ERROR_OF_MEAN|4.7651||0.826|TWO_SIDED|95.0|-8.525|10.626|||ANCOVA|||Dysglycemic||10.626|-8.525|0.826
72460548|NCT03320941|144444173|OTHER|Dose Finding|Mean Difference (Final Values)|4.182|STANDARD_ERROR_OF_MEAN|4.7627||0.384|TWO_SIDED|95.0|-5.389|13.753|||ANCOVA|||Dysglycemic||13.753|-5.389|0.384
72460549|NCT03320941|144444173|OTHER|Dose Finding|Mean Difference (Final Values)|5.563|STANDARD_ERROR_OF_MEAN|4.4636||0.217|TWO_SIDED|95.0|-3.36|14.486|||ANCOVA|||T2DM||14.486|-3.360|0.217
72460550|NCT03320941|144444173|OTHER|Dose Finding|Mean Difference (Final Values)|-2.019|STANDARD_ERROR_OF_MEAN|4.5491||0.659|TWO_SIDED|95.0|-11.112|7.074|||ANCOVA|||T2DM||7.074|-11.112|0.659
72460551|NCT03320941|144444173|OTHER|Dose Finding|Mean Difference (Final Values)|-4.316|STANDARD_ERROR_OF_MEAN|4.0556||0.291|TWO_SIDED|95.0|-12.423|3.791|||ANCOVA|||T2DM||3.791|-12.423|0.291
72563401|NCT00442546|144658172|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.316|STANDARD_ERROR_OF_MEAN|2.59||0.0416||95.0|0.204|10.427|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4||10.427|0.204|0.0416
72460552|NCT03320941|144444173|OTHER|Dose Finding|Mean Difference (Final Values)|2.913|STANDARD_ERROR_OF_MEAN|4.0035||0.47|TWO_SIDED|95.0|-5.09|10.916|||ANCOVA|||T2DM||10.916|-5.090|0.470
72392609|NCT00903695|144292460|SUPERIORITY_OR_OTHER|||||||0.27||||||a priori threshold for statistical significance = 0.01 (multiple comparisons)|ANOVA|"DF = 6~ANOVA: F-ratio = 1.5, t-test = -1.23"||ANOVA used to detect significant difference in test scores between baseline and end assessments, by study arm (nutriceutical vs placebo).||||0.27
72392610|NCT00903695|144292461|SUPERIORITY_OR_OTHER|||||||0.24||||||a priori threshold for statistical significance = 0.01 (multiple comparisons)|ANOVA|"DF = 6~ANOVA: F-ratio = 1.7, t-test = 1.3"||ANOVA used to detect significant difference in test scores between baseline and end assessments, by study arm (nutriceutical vs placebo).||||0.24
72460553|NCT03320941|144444174|OTHER|Dose Finding|Mean Difference (Final Values)|1.308|STANDARD_ERROR_OF_MEAN|5.2049||0.802|TWO_SIDED|95.0|-9.001|11.617|||ANCOVA|||Overall Study||11.617|-9.001|0.802
72460554|NCT03320941|144444174|OTHER|Dose Finding|Mean Difference (Final Values)|-1.812|STANDARD_ERROR_OF_MEAN|5.4301||0.739|TWO_SIDED|95.0|-12.567|8.943|||ANCOVA|||Overall Study||8.943|-12.567|0.739
72460555|NCT03320941|144444174|OTHER|Dose Finding|Mean Difference (Final Values)|0.588|STANDARD_ERROR_OF_MEAN|4.7125||0.901|TWO_SIDED|95.0|-8.745|9.922|||ANCOVA|||Overall Study||9.922|-8.745|0.901
72460556|NCT03320941|144444174|OTHER|Dose Finding|Mean Difference (Final Values)|5.278|STANDARD_ERROR_OF_MEAN|4.6095||0.255|TWO_SIDED|95.0|-3.852|14.407|||ANCOVA|||Overall Study||14.407|-3.852|0.255
72460557|NCT03320941|144444174|OTHER|Dose Finding|Mean Difference (Final Values)|0.928|STANDARD_ERROR_OF_MEAN|8.5585||0.914|TWO_SIDED|95.0|-16.271|18.127|||ANCOVA|||Dysglycemic||18.127|-16.271|0.914
72460558|NCT03320941|144444174|OTHER|Dose Finding|Mean Difference (Final Values)|-0.48|STANDARD_ERROR_OF_MEAN|9.2308||0.959|TWO_SIDED|95.0|-19.03|18.07|||ANCOVA|||Dysglycemic||18.070|-19.030|0.959
72460559|NCT03320941|144444174|OTHER|Dose Finding|Mean Difference (Final Values)|6.572|STANDARD_ERROR_OF_MEAN|7.422||0.38|TWO_SIDED|95.0|-8.343|21.487|||ANCOVA|||Dysglycemic||21.487|-8.343|0.380
72460560|NCT03320941|144444174|OTHER|Dose Finding|Mean Difference (Final Values)|6.121|STANDARD_ERROR_OF_MEAN|7.5174||0.419|TWO_SIDED|95.0|-8.986|21.228|||ANCOVA|||Dysglycemic||21.228|-8.986|0.419
72392611|NCT00903695|144292462|SUPERIORITY_OR_OTHER|||||||0.71||95.0||||a priori threshold for statistical significance = 0.01 (multiple comparisons)|ANOVA|"DF = 6~ANOVA: F-ratio = 0.15, t-test = 0.39"||ANOVA used to detect significant difference in test scores between baseline and end assessments, by study arm (nutriceutical vs placebo).||||0.71
72460561|NCT03320941|144444174|OTHER|Dose Finding|Mean Difference (Final Values)|0.785|STANDARD_ERROR_OF_MEAN|6.6209||0.906|TWO_SIDED|95.0|-12.45|14.02|||ANCOVA|||T2DM||14.020|-12.450|0.906
72460562|NCT03320941|144444174|OTHER|Dose Finding|Mean Difference (Final Values)|-4.504|STANDARD_ERROR_OF_MEAN|6.8489||0.513|TWO_SIDED|95.0|-18.195|9.187|||ANCOVA|||T2DM||9.187|-18.195|0.513
72460563|NCT03320941|144444174|OTHER|Dose Finding|Mean Difference (Final Values)|-4.237|STANDARD_ERROR_OF_MEAN|6.23||0.499|TWO_SIDED|95.0|-16.691|8.216|||ANCOVA|||T2DM||8.216|-16.691|0.499
72460564|NCT03320941|144444174|OTHER|Dose Finding|Mean Difference (Final Values)|3.86|STANDARD_ERROR_OF_MEAN|5.9073||0.516|TWO_SIDED|95.0|-7.948|15.669|||ANCOVA|||T2DM||15.669|-7.948|0.516
72460565|NCT03320941|144444175|OTHER|Dose Finding|Mean Difference (Final Values)|44.82||||0.625|TWO_SIDED|95.0|-136.644|226.284|||ANCOVA|||Overall Study||226.284|-136.644|0.625
72460566|NCT03320941|144444175|OTHER|Dose Finding|Mean Difference (Final Values)|162.273||||0.079|TWO_SIDED|95.0|-19.326|343.871|||ANCOVA|||Overall Study||343.871|-19.326|0.079
72460567|NCT03320941|144444175|OTHER|Dose Finding|Mean Difference (Final Values)|69.062||||0.384|TWO_SIDED|95.0|-87.493|225.617|||ANCOVA|||Overall Study||225.617|-87.493|0.384
72460568|NCT03320941|144444175|OTHER|Dose Finding|Mean Difference (Final Values)|37.733||||0.627|TWO_SIDED|95.0|-115.58|191.045|||ANCOVA|||Overall Study||191.045|-115.580|0.627
72460569|NCT03320941|144444175|OTHER|Dose Finding|Mean Difference (Final Values)|22.879||||0.797|TWO_SIDED|95.0|-155.244|201.003|||ANCOVA|||Dysglycemic||201.003|-155.244|0.797
72460570|NCT03320941|144444175|OTHER|Dose Finding|Mean Difference (Final Values)|12.891||||0.882|TWO_SIDED|95.0|-160.215|185.996|||ANCOVA|||Dysglycemic||185.996|-160.215|0.882
72563402|NCT00442546|144658172|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.372|STANDARD_ERROR_OF_MEAN|2.566||0.5935||95.0|-3.694|6.438|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET||6.438|-3.694|0.5935
72392612|NCT00903695|144292463|SUPERIORITY_OR_OTHER|||||||0.18||||||a priori threshold for statistical significance = 0.01 (multiple comparisons)|ANOVA|"DF = 6~ANOVA: F-ratio = 2.25, ttest = -1.5"||ANOVA used to detect significant difference in test scores between baseline and end assessments, by study arm (nutriceutical vs placebo).||||0.18
72392613|NCT00903695|144292464|SUPERIORITY_OR_OTHER|||||||0.34||||||a priori threshold for statistical significance = 0.01 (multiple comparisons)|ANOVA|"DF = 6~ANOVA: F-ratio = 1.06, t-test = -1.03"||ANOVA used to detect significant difference in test scores between baseline and end assessments, by study arm (nutriceutical vs placebo).||||0.34
72392614|NCT00543140|144292493|SUPERIORITY_OR_OTHER|||||||0.6919|TWO_SIDED|||||No adjustments for multiple comparisons were performed as only one hypothesis was tested in this study. The level of significance was set at 0.05.|Exact Binomial method|||The primary analysis used a one-sided binomial exact test method by Clopper and Pearson to determine if the rate of reoperations observed in Years 4 and 5 (combined) of the study was significantly less than 8%. The null hypothesis was that the reoperation rate was greater than or equal to 8%.||||0.6919
72460571|NCT03320941|144444175|OTHER|Dose Finding|Mean Difference (Final Values)|-30.447||||0.675|TWO_SIDED|95.0|-175.796|114.902|||ANCOVA|||Dysglycemic||114.902|-175.796|0.675
72460572|NCT03320941|144444175|OTHER|Dose Finding|Mean Difference (Final Values)|-37.264||||0.607|TWO_SIDED|95.0|-182.099|107.571|||ANCOVA|||Dysglycemic||107.571|-182.099|0.607
72460573|NCT03320941|144444175|OTHER|Dose Finding|Mean Difference (Final Values)|84.822||||0.591|TWO_SIDED|95.0|-229.131|398.775|||ANCOVA|||T2DM||398.775|-229.131|0.591
72563403|NCT00442546|144658172|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.272|STANDARD_ERROR_OF_MEAN|2.674||0.3966||95.0|-3.006|7.551|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET||7.551|-3.006|0.3966
72460574|NCT03320941|144444175|OTHER|Dose Finding|Mean Difference (Final Values)|287.328||||0.066|TWO_SIDED|95.0|-19.533|594.19|||ANCOVA|||T2DM||594.190|-19.533|0.066
72460575|NCT03320941|144444175|OTHER|Dose Finding|Mean Difference (Final Values)|156.017||||0.252|TWO_SIDED|95.0|-113.963|425.997|||ANCOVA|||T2DM||425.997|-113.963|0.252
72563404|NCT00442546|144658173|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.729|STANDARD_ERROR_OF_MEAN|2.631||0.5117||95.0|-3.457|6.916|||ANOVA||Mean difference (final values) = Least squares mean difference|24 hours||6.916|-3.457|0.5117
72392615|NCT02270957|144292530|SUPERIORITY||||||>|0.999|||||||Chi-squared|||||||>0.999
72392616|NCT02270957|144292531|SUPERIORITY|||||||0.587|||||||Chi-squared|||||||0.587
72392617|NCT02270957|144292532|SUPERIORITY|||||||0.587|TWO_SIDED|95.0||||None of the endpoints were met in any pre-specified unbiased Full Analysis Set analysis|Chi-squared|||||||0.587
72392618|NCT01246401|144292535|SUPERIORITY|||||||0.431|||||||Welch's T Test|||||||0.431
72460576|NCT03320941|144444175|OTHER|Dose Finding|Mean Difference (Final Values)|103.135||||0.431|TWO_SIDED|95.0|-157.287|363.556|||ANCOVA|||T2DM||363.556|-157.287|0.431
72460577|NCT03320941|144444176|OTHER|Dose Finding|Mean Difference (Final Values)|-65.1|STANDARD_ERROR_OF_MEAN|13.03|<|0.001|TWO_SIDED|95.0|-90.864|-39.251|||ANCOVA|||Overall Study||-39.251|-90.864|<0.001
72460578|NCT03320941|144444176|OTHER|Dose Finding|Mean Difference (Final Values)|-67.7|STANDARD_ERROR_OF_MEAN|13.21|<|0.001|TWO_SIDED|95.0|-93.848|-41.542|||ANCOVA|||Overall Study||-41.542|-93.848|<0.001
72563405|NCT00442546|144658173|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|6.532|STANDARD_ERROR_OF_MEAN|2.675||0.0154||95.0|1.258|11.805|||ANOVA||Mean difference (final values) = Least squares mean difference|24 hours||11.805|1.258|0.0154
72563406|NCT00442546|144658173|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.901|STANDARD_ERROR_OF_MEAN|2.353||0.7022||95.0|-3.738|5.54|||ANOVA||Mean difference (final values) = Least squares mean difference|48 hours||5.540|-3.738|0.7022
72563407|NCT00442546|144658173|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.509|STANDARD_ERROR_OF_MEAN|2.343||0.0557||95.0|-0.11|9.129|||ANOVA||Mean difference (final values) = Least squares mean difference|48 hours||9.129|-0.110|0.0557
72563408|NCT00442546|144658173|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.171|STANDARD_ERROR_OF_MEAN|2.552||0.2161||95.0|-1.874|8.215|||ANOVA||Mean difference (final values) = Least squares mean difference|72 hours||8.215|-1.874|0.2161
72392619|NCT01246401|144292536|SUPERIORITY|||||||0.087|||||||Welch's T Test|||||||0.087
72392620|NCT01246401|144292538|SUPERIORITY|||||||0.03||||||Wilcoxon one sided|Wilcoxon (Mann-Whitney)|||||||0.03
72392621|NCT01246401|144292543|SUPERIORITY|||||||0.03962|||||||Chi-squared|||||||0.03962
72392622|NCT00919724|144292545|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.99|STANDARD_ERROR_OF_MEAN|0.6||0.1||||||Comparison between HIV-infected and HIV-uninfected groups. Comparison adjusted for age, gender, race, height, and brachial artery baseline diameter.|Regression, Linear|||||||0.10
72392623|NCT00166114|144292546|SUPERIORITY_OR_OTHER|||||||0.918|||||||Chi-squared|||Chi Square test was performed comparing actual vs. expected non- and partial response or response to either escitalopram or desipramine treatment.||||.918
72392624|NCT01218204|144292587|SUPERIORITY_OR_OTHER||Mean Difference (Net)|5.473|||||TWO_SIDED|95.0|-15.7096|26.6553|||||Statistical analysis was performed using LS mean value of Atorvastatin|Atorvastatin 10 mg + GSK1292263 100 mg vs Placebo: Apolipoprotein A1||26.6553|-15.7096|
72460579|NCT03320941|144444176|OTHER|Dose Finding|Mean Difference (Final Values)|-70.8|STANDARD_ERROR_OF_MEAN|11.67|<|0.001|TWO_SIDED|95.0|-93.942|-47.735|||ANCOVA|||Overall Study||-47.735|-93.942|<0.001
72460580|NCT03320941|144444176|OTHER|Dose Finding|Mean Difference (Final Values)|-74.4|STANDARD_ERROR_OF_MEAN|11.47|<|0.001|TWO_SIDED|95.0|-97.117|-51.704|||ANCOVA|||Overall Study||-51.704|-97.117|<0.001
72460581|NCT03320941|144444176|OTHER|Dose Finding|Mean Difference (Final Values)|-86.9|STANDARD_ERROR_OF_MEAN|24.35|<|0.001|TWO_SIDED|95.0|-135.78|-38.013|||ANCOVA|||Dysglycemic||-38.013|-135.780|<0.001
72460582|NCT03320941|144444176|OTHER|Dose Finding|Mean Difference (Final Values)|-86.1|STANDARD_ERROR_OF_MEAN|24.01|<|0.001|TWO_SIDED|95.0|-134.266|-37.874|||ANCOVA|||Dysglycemic||-37.874|-134.266|<0.001
72460583|NCT03320941|144444176|OTHER|Dose Finding|Mean Difference (Final Values)|-81.1|STANDARD_ERROR_OF_MEAN|21.04|<|0.001|TWO_SIDED|95.0|-123.369|-38.883|||ANCOVA|||Dysglycemic||-38.883|-123.369|<0.001
72460584|NCT03320941|144444176|OTHER|Dose Finding|Mean Difference (Final Values)|-84.9|STANDARD_ERROR_OF_MEAN|21.03|<|0.001|TWO_SIDED|95.0|-127.104|-42.669|||ANCOVA|||Dysglycemic||-42.669|-127.104|<0.001
72460585|NCT03320941|144444176|OTHER|Dose Finding|Mean Difference (Final Values)|-47.5|STANDARD_ERROR_OF_MEAN|13.52|<|0.001|TWO_SIDED|95.0|-74.493|-20.461|||ANCOVA|||T2DM||-20.461|-74.493|<0.001
72460586|NCT03320941|144444176|OTHER|Dose Finding|Mean Difference (Final Values)|-53.1|STANDARD_ERROR_OF_MEAN|13.93|<|0.001|TWO_SIDED|95.0|-80.914|-25.251|||ANCOVA|||T2DM||-25.251|-80.914|<0.001
72563409|NCT00442546|144658173|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|7.135|STANDARD_ERROR_OF_MEAN|2.548||0.0058||95.0|2.098|12.172|||ANOVA||Mean difference (final values) = Least squares mean difference|72 hours||12.172|2.098|0.0058
72460587|NCT03320941|144444176|OTHER|Dose Finding|Mean Difference (Final Values)|-61.8|STANDARD_ERROR_OF_MEAN|12.43|<|0.001|TWO_SIDED|95.0|-86.627|-36.937|||ANCOVA|||T2DM||-36.937|-86.627|<0.001
72460588|NCT03320941|144444176|OTHER|Dose Finding|Mean Difference (Final Values)|-65.0|STANDARD_ERROR_OF_MEAN|12.15|<|0.001|TWO_SIDED|95.0|-89.291|-40.713|||ANCOVA|||T2DM||-40.713|-89.291|<0.001
72460589|NCT03320941|144444177|OTHER|Dose Finding|Mean Difference (Final Values)|-0.556|STANDARD_ERROR_OF_MEAN|1.845||0.764|TWO_SIDED|95.0|-4.21|3.098|||ANCOVA|||Overall Study||3.098|-4.210|0.764
72563410|NCT00442546|144658173|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|6.185|STANDARD_ERROR_OF_MEAN|3.993||0.1283||95.0|-1.853|14.223|||ANOVA||Mean difference (final values) = Least squares mean difference|96 hours||14.223|-1.853|0.1283
72460590|NCT03320941|144444177|OTHER|Dose Finding|Mean Difference (Final Values)|1.289|STANDARD_ERROR_OF_MEAN|1.8741||0.493|TWO_SIDED|95.0|-2.423|5.001|||ANCOVA|||Overall Study||5.001|-2.423|0.493
72460591|NCT03320941|144444177|OTHER|Dose Finding|Mean Difference (Final Values)|-2.621|STANDARD_ERROR_OF_MEAN|1.6596||0.117|TWO_SIDED|95.0|-5.908|0.666|||ANCOVA|||Overall Study||0.666|-5.908|0.117
72563411|NCT00442546|144658173|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|11.173|STANDARD_ERROR_OF_MEAN|4.033||0.008||95.0|3.056|19.291|||ANOVA||Mean difference (final values) = Least squares mean difference|96 hours||19.291|3.056|0.0080
72460592|NCT03320941|144444177|OTHER|Dose Finding|Mean Difference (Final Values)|-1.818|STANDARD_ERROR_OF_MEAN|1.6349||0.269|TWO_SIDED|95.0|-5.056|1.421|||ANCOVA|||Overall Study||1.421|-5.056|0.269
72460593|NCT03320941|144444177|OTHER|Dose Finding|Mean Difference (Final Values)|1.671|STANDARD_ERROR_OF_MEAN|1.1677||0.159|TWO_SIDED|95.0|-0.676|4.017|||ANCOVA|||Dysglycemic||4.017|-0.676|0.159
72460594|NCT03320941|144444177|OTHER|Dose Finding|Mean Difference (Final Values)|5.641|STANDARD_ERROR_OF_MEAN|1.1678|<|0.001|TWO_SIDED|95.0|3.294|7.988|||ANCOVA|||Dysglycemic||7.988|3.294|<0.001
72460595|NCT03320941|144444177|OTHER|Dose Finding|Mean Difference (Final Values)|1.155|STANDARD_ERROR_OF_MEAN|1.0371||0.271|TWO_SIDED|95.0|-0.929|3.239|||ANCOVA|||Dysglycemic||3.239|-0.929|0.271
72460596|NCT03320941|144444177|OTHER|Dose Finding|Mean Difference (Final Values)|0.206|STANDARD_ERROR_OF_MEAN|1.019||0.841|TWO_SIDED|95.0|-1.842|2.253|||ANCOVA|||Dysglycemic||2.253|-1.842|0.841
72460597|NCT03320941|144444177|OTHER|Dose Finding|Mean Difference (Final Values)|-3.725|STANDARD_ERROR_OF_MEAN|2.518||0.144|TWO_SIDED|95.0|-8.758|1.309|||ANCOVA|||T2DM||1.309|-8.758|0.144
72460598|NCT03320941|144444177|OTHER|Dose Finding|Mean Difference (Final Values)|-0.877|STANDARD_ERROR_OF_MEAN|2.5906||0.736|TWO_SIDED|95.0|-6.055|4.302|||ANCOVA|||T2DM||4.302|-6.055|0.736
72620979|NCT01703221|144772904|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Omarigliptin will be considered non-inferior to sitagliptin if the upper bound of the two-sided 95% confidence interval of the between-treatment difference in least squares means for change from baseline in HbA1c at Week 24 (omarigliptin minus sitagliptin) is not more than 0.3% (non-inferiority margin).|Difference in the least squares means|-0.02||||0.792|TWO_SIDED|95.0|-0.15|0.12|||Constrained longitudinal analysis|Terms for treatment, prior AHA therapy status (yes/no), time, and time by: treatment, prior AHA therapy status, and treatment by prior AHA status.||||0.12|-0.15|0.792
72620980|NCT01703221|144772909|SUPERIORITY_OR_OTHER_LEGACY||Difference in the least squares means|-36.89|||<|0.001|TWO_SIDED|95.0|-48.46|-25.33|||Constrained longitudinal analysis|Terms for treatment, prior AHA therapy status (yes/no), time, and time by: treatment, prior AHA therapy status, and treatment by prior AHA status.||||-25.33|-48.46|<0.001
72620981|NCT01703221|144772909|SUPERIORITY_OR_OTHER_LEGACY||Difference in the least squares means|-39.76|||<|0.001|TWO_SIDED|95.0|-51.28|-28.23|||Constrained longitudinal analysis|Terms for treatment, prior AHA therapy status (yes/no), time, and time by: treatment, prior AHA therapy status, and treatment by prior AHA status.||||-28.23|-51.28|<0.001
72620982|NCT01703221|144772909|SUPERIORITY_OR_OTHER_LEGACY||Difference in the least squares means|2.86||||0.555|TWO_SIDED|95.0|-6.67|12.39|||Constrained longitudinal analysis|Terms for treatment, prior AHA therapy status (yes/no), time, and time by: treatment, prior AHA therapy status, and treatment by prior AHA status.||||12.39|-6.67|0.555
72620983|NCT01703221|144772910|SUPERIORITY_OR_OTHER_LEGACY||Difference in the least squares means|-12.28|||<|0.001|TWO_SIDED|95.0|-17.78|-6.78|||Constrained longitudinal analysis|Terms for treatment, prior AHA therapy status (yes/no), time, and time by: treatment, prior AHA therapy status, and treatment by prior AHA status.||||-6.78|-17.78|<0.001
72620984|NCT01703221|144772910|SUPERIORITY_OR_OTHER_LEGACY||Difference in the least squares means|-14.51|||<|0.001|TWO_SIDED|95.0|-20.04|-8.98|||Constrained longitudinal analysis|Terms for treatment, prior AHA therapy status (yes/no), time, and time by: treatment, prior AHA therapy status, and treatment by prior AHA status.||||-8.98|-20.04|<0.001
72620985|NCT01703221|144772910|SUPERIORITY_OR_OTHER_LEGACY||Difference in the least squares means|2.23||||0.33|TWO_SIDED|95.0|-2.27|6.73|||Constrained longitudinal analysis|Terms for treatment, prior AHA therapy status (yes/no), time, and time by: treatment, prior AHA therapy status, and treatment by prior AHA status.||||6.73|-2.27|0.330
72460599|NCT03320941|144444177|OTHER|Dose Finding|Mean Difference (Final Values)|-3.431|STANDARD_ERROR_OF_MEAN|2.3113||0.143|TWO_SIDED|95.0|-8.051|1.19|||ANCOVA|||T2DM||1.190|-8.051|0.143
72460600|NCT03320941|144444177|OTHER|Dose Finding|Mean Difference (Final Values)|-1.991|STANDARD_ERROR_OF_MEAN|2.2659||0.383|TWO_SIDED|95.0|-6.521|2.538|||ANCOVA|||T2DM||2.538|-6.521|0.383
72460601|NCT03320941|144444178|OTHER|Dose Finding|Mean Difference (Final Values)|0.654|STANDARD_ERROR_OF_MEAN|1.1543||0.572|TWO_SIDED|95.0|-1.632|2.941|||ANCOVA|||Overall Study||2.941|-1.632|0.572
72501313|NCT00733902|144532356|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.39|STANDARD_ERROR_OF_MEAN|0.28|<|0.001|TWO_SIDED|95.0|-1.94|-0.84|||ANCOVA|||Change at Week 24: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.84|-1.94|<0.001
72460602|NCT03320941|144444178|OTHER|Dose Finding|Mean Difference (Final Values)|0.655|STANDARD_ERROR_OF_MEAN|1.1738||0.578|TWO_SIDED|95.0|-1.67|2.98|||ANCOVA|||Overall Study||2.980|-1.670|0.578
72501314|NCT00733902|144532359|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.32|STANDARD_ERROR_OF_MEAN|0.09|<|0.001|TWO_SIDED|95.0|-0.49|-0.14|||ANCOVA|||Change at Week 2: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.14|-0.49|<0.001
72620986|NCT00834587|144772947|NON_INFERIORITY_OR_EQUIVALENCE|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Test/Ref Ratio of LS Means x 100|99.1||||||90.0|92.4|106.2|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||106.2|92.4|
72620987|NCT00834587|144772948|NON_INFERIORITY_OR_EQUIVALENCE|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Test/Ref Ratio of LS Means x 100|100.7||||||90.0|98.8|102.6|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||102.6|98.8|
72460603|NCT03320941|144444178|OTHER|Dose Finding|Mean Difference (Final Values)|-1.048|STANDARD_ERROR_OF_MEAN|1.0479||0.319|TWO_SIDED|95.0|-3.124|1.028|||ANCOVA|||Overall Study||1.028|-3.124|0.319
72620988|NCT00834587|144772949|NON_INFERIORITY_OR_EQUIVALENCE|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Test/Ref Ratio of LS Means x 100|100.6||||||90.0|98.8|102.5|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||102.5|98.8|
72620989|NCT00834587|144772950|NON_INFERIORITY_OR_EQUIVALENCE|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Test/Ref Ratio of LS Means x 100|101.7||||||90.0|97.3|106.3|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||106.3|97.3|
72460604|NCT03320941|144444178|OTHER|Dose Finding|Mean Difference (Final Values)|-0.374|STANDARD_ERROR_OF_MEAN|1.0303||0.717|TWO_SIDED|95.0|-2.416|1.667|||ANCOVA|||Overall Study||1.667|-2.416|0.717
72460605|NCT03320941|144444178|OTHER|Dose Finding|Mean Difference (Final Values)|0.57|STANDARD_ERROR_OF_MEAN|0.563||0.317|TWO_SIDED|95.0|-0.562|1.701|||ANCOVA|||Dysglycemic||1.701|-0.562|0.317
72460606|NCT03320941|144444178|OTHER|Dose Finding|Mean Difference (Final Values)|1.609|STANDARD_ERROR_OF_MEAN|0.5716||0.007|TWO_SIDED|95.0|0.46|2.758|||ANCOVA|||Dysglycemic||2.758|0.460|0.007
72460607|NCT03320941|144444178|OTHER|Dose Finding|Mean Difference (Final Values)|0.352|STANDARD_ERROR_OF_MEAN|0.5029||0.487|TWO_SIDED|95.0|-0.659|1.362|||ANCOVA|||Dysglycemic||1.362|-0.659|0.487
72501315|NCT00733902|144532359|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.09||0.486|TWO_SIDED|95.0|-0.24|0.11|||ANCOVA|||Change at Week 2: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||0.11|-0.24|0.486
72460608|NCT03320941|144444178|OTHER|Dose Finding|Mean Difference (Final Values)|0.104|STANDARD_ERROR_OF_MEAN|0.4917||0.833|TWO_SIDED|95.0|-0.884|1.092|||ANCOVA|||Dysglycemic||1.092|-0.884|0.833
72460609|NCT03320941|144444178|OTHER|Dose Finding|Mean Difference (Final Values)|0.605|STANDARD_ERROR_OF_MEAN|2.073||0.771|TWO_SIDED|95.0|-3.541|4.752|||ANCOVA|||T2DM||4.752|-3.541|0.771
72460610|NCT03320941|144444178|OTHER|Dose Finding|Mean Difference (Final Values)|-0.024|STANDARD_ERROR_OF_MEAN|2.1453||0.991|TWO_SIDED|95.0|-4.315|4.267|||ANCOVA|||T2DM||4.267|-4.315|0.991
72460611|NCT03320941|144444178|OTHER|Dose Finding|Mean Difference (Final Values)|-2.166|STANDARD_ERROR_OF_MEAN|1.9486||0.271|TWO_SIDED|95.0|-6.064|1.732|||ANCOVA|||T2DM||1.732|-6.064|0.271
72460612|NCT03320941|144444178|OTHER|Dose Finding|Mean Difference (Final Values)|-0.792|STANDARD_ERROR_OF_MEAN|1.8889||0.676|TWO_SIDED|95.0|-4.57|2.986|||ANCOVA|||T2DM||2.986|-4.570|0.676
72460613|NCT03320941|144444179|OTHER|Dose Finding|Mean Difference (Final Values)|-0.19|STANDARD_ERROR_OF_MEAN|4.7535||0.968|TWO_SIDED|95.0|-9.603|9.222|||ANCOVA|||Overall Study||9.222|-9.603|0.968
72460614|NCT03320941|144444179|OTHER|Dose Finding|Mean Difference (Final Values)|-1.883|STANDARD_ERROR_OF_MEAN|4.7545||0.693|TWO_SIDED|95.0|-11.297|7.531|||ANCOVA|||Overall Study||7.531|-11.297|0.693
72460615|NCT03320941|144444179|OTHER|Dose Finding|Mean Difference (Final Values)|-5.236|STANDARD_ERROR_OF_MEAN|4.2623||0.222|TWO_SIDED|95.0|-13.676|3.203|||ANCOVA|||Overall Study||3.203|-13.676|0.222
72460616|NCT03320941|144444179|OTHER|Dose Finding|Mean Difference (Final Values)|-7.403|STANDARD_ERROR_OF_MEAN|4.1637||0.078|TWO_SIDED|95.0|-15.648|0.841|||ANCOVA|||Overall Study||0.841|-15.648|0.078
72460617|NCT03320941|144444179|OTHER|Dose Finding|Mean Difference (Final Values)|-1.142|STANDARD_ERROR_OF_MEAN|6.0033||0.85|TWO_SIDED|95.0|-13.194|10.91|||ANCOVA|||Dysglycemic||10.910|-13.194|0.850
72460618|NCT03320941|144444179|OTHER|Dose Finding|Mean Difference (Final Values)|-6.048|STANDARD_ERROR_OF_MEAN|5.7919||0.301|TWO_SIDED|95.0|-17.676|5.58|||ANCOVA|||Dysglycemic||5.580|-17.676|0.301
72460619|NCT03320941|144444179|OTHER|Dose Finding|Mean Difference (Final Values)|-5.587|STANDARD_ERROR_OF_MEAN|5.2598||0.293|TWO_SIDED|95.0|-16.147|4.972|||ANCOVA|||Dysglycemic||4.972|-16.147|0.293
72460620|NCT03320941|144444179|OTHER|Dose Finding|Mean Difference (Final Values)|-6.943|STANDARD_ERROR_OF_MEAN|5.2191||0.189|TWO_SIDED|95.0|-17.421|3.535|||ANCOVA|||Dysglycemic||3.535|-17.421|0.189
72460621|NCT03320941|144444179|OTHER|Dose Finding|Mean Difference (Final Values)|0.676|STANDARD_ERROR_OF_MEAN|7.2441||0.926|TWO_SIDED|95.0|-13.8|15.152|||ANCOVA|||T2DM||15.152|-13.800|0.926
72460622|NCT03320941|144444179|OTHER|Dose Finding|Mean Difference (Final Values)|1.202|STANDARD_ERROR_OF_MEAN|7.5086||0.873|TWO_SIDED|95.0|-13.802|16.207|||ANCOVA|||T2DM||16.207|-13.802|0.873
72460623|NCT03320941|144444179|OTHER|Dose Finding|Mean Difference (Final Values)|-5.779|STANDARD_ERROR_OF_MEAN|6.6977||0.391|TWO_SIDED|95.0|-19.164|7.605|||ANCOVA|||T2DM||7.605|-19.164|0.391
72460624|NCT03320941|144444179|OTHER|Dose Finding|Mean Difference (Final Values)|-7.591|STANDARD_ERROR_OF_MEAN|6.3822||0.239|TWO_SIDED|95.0|-20.345|5.163|||ANCOVA|||T2DM||5.163|-20.345|0.239
72460625|NCT03320941|144444180|OTHER|Dose Finding|Mean Difference (Final Values)|-3.086|STANDARD_ERROR_OF_MEAN|2.8326||0.278|TWO_SIDED|95.0|-8.696|2.525|||ANCOVA|||Overall Study||2.525|-8.696|0.278
72501316|NCT00733902|144532359|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.24|STANDARD_ERROR_OF_MEAN|0.09||0.008|TWO_SIDED|95.0|-0.42|-0.06|||ANCOVA|||Change at Week 2: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.06|-0.42|0.008
72460626|NCT03320941|144444180|OTHER|Dose Finding|Mean Difference (Final Values)|-0.977|STANDARD_ERROR_OF_MEAN|2.859||0.733|TWO_SIDED|95.0|-6.639|4.686|||ANCOVA|||Overall Study||4.686|-6.639|0.733
72460627|NCT03320941|144444180|OTHER|Dose Finding|Mean Difference (Final Values)|-4.507|STANDARD_ERROR_OF_MEAN|2.5118||0.075|TWO_SIDED|95.0|-9.482|0.468|||ANCOVA|||Overall Study||0.468|-9.482|0.075
72460628|NCT03320941|144444180|OTHER|Dose Finding|Mean Difference (Final Values)|-2.268|STANDARD_ERROR_OF_MEAN|2.4659||0.36|TWO_SIDED|95.0|-7.152|2.616|||ANCOVA|||Overall Study||2.616|-7.152|0.360
72460629|NCT03320941|144444180|OTHER|Dose Finding|Mean Difference (Final Values)|-3.147|STANDARD_ERROR_OF_MEAN|4.1699||0.416|TWO_SIDED|95.0|-11.792|4.959|||ANCOVA|||Dysglycemic||4.959|-11.792|0.416
72460630|NCT03320941|144444180|OTHER|Dose Finding|Mean Difference (Final Values)|-1.634|STANDARD_ERROR_OF_MEAN|4.1121||0.693|TWO_SIDED|95.0|-9.893|6.625|||ANCOVA|||Dysglycemic||6.625|-9.893|0.693
72460631|NCT03320941|144444180|OTHER|Dose Finding|Mean Difference (Final Values)|-2.906|STANDARD_ERROR_OF_MEAN|3.6351||0.428|TWO_SIDED|95.0|-10.207|4.396|||ANCOVA|||Dysglycemic||4.396|-10.207|0.428
72460632|NCT03320941|144444180|OTHER|Dose Finding|Mean Difference (Final Values)|2.201|STANDARD_ERROR_OF_MEAN|3.6414||0.548|TWO_SIDED|95.0|-5.113|9.515|||ANCOVA|||Dysglycemic||9.515|-5.113|0.548
72460633|NCT03320941|144444180|OTHER|Dose Finding|Mean Difference (Final Values)|-2.636|STANDARD_ERROR_OF_MEAN|3.8828||0.5|TWO_SIDED|95.0|-10.4|5.128|||ANCOVA|||T2DM||5.128|-10.400|0.500
72460634|NCT03320941|144444180|OTHER|Dose Finding|Mean Difference (Final Values)|-0.826|STANDARD_ERROR_OF_MEAN|3.9906||0.837|TWO_SIDED|95.0|-8.805|7.154|||ANCOVA|||T2DM||7.154|-8.805|0.837
72460635|NCT03320941|144444180|OTHER|Dose Finding|Mean Difference (Final Values)|-5.594|STANDARD_ERROR_OF_MEAN|3.4818||0.113|TWO_SIDED|95.0|-12.556|1.368|||ANCOVA|||T2DM||1.368|-12.556|0.113
72460636|NCT03320941|144444180|OTHER|Dose Finding|Mean Difference (Final Values)|-5.66|STANDARD_ERROR_OF_MEAN|3.3512||0.096|TWO_SIDED|95.0|-12.361|1.041|||ANCOVA|||T2DM||1.041|-12.361|0.096
72460637|NCT03614923|144444182|SUPERIORITY|Statistical significance for the co-primary efficacy endpoints would be declared if both p-values for the tests of the individual hypotheses were \< 0.05.|Least Squares (LS) Mean Difference|-0.38|STANDARD_ERROR_OF_MEAN|0.319||0.2364|TWO_SIDED|95.0|-1.01|0.25||Testing was conducted in a hierarchical manner such that the comparison of etokimab Q4W versus placebo was conducted first. If the results of this comparison were statistically significant, the etokimab Q8W treatment arm would be compared to placebo.|General linear MMRM|||A general linear mixed effects model with repeated measures (MMRM) was used including the change from Baseline in NPS as dependent variable; treatment group, stratification factor, time (Weeks 4, 8, 12, and 16), treatment by stratification factor, and treatment by time interaction as fixed effect factors; Baseline NPS as covariate; and subject as random effect.||0.25|-1.01|0.2364
72460638|NCT03614923|144444182|SUPERIORITY|Statistical significance for the co-primary efficacy endpoints was to be declared if both p-values for the tests of the individual hypotheses were \< 0.05.|LS Mean Difference|-0.41|STANDARD_ERROR_OF_MEAN|0.316||0.2024|TWO_SIDED|95.0|-1.03|0.22||Testing was conducted in a hierarchical manner such that the comparison of etokimab Q4W versus placebo was conducted first. If the results of this comparison were statistically significant, the etokimab Q8W treatment arm would be compared to placebo.|General linear MMRM|||A general linear mixed effects model with repeated measures (MMRM) was used including the change from Baseline in NPS as dependent variable; treatment group, stratification factor, time (Weeks 4, 8, 12, and 16), treatment by stratification factor, and treatment by time interaction as fixed effect factors; Baseline NPS as covariate; and subject as random effect.||0.22|-1.03|0.2024
72460639|NCT03614923|144444183|SUPERIORITY|Statistical significance for the co-primary efficacy endpoints was to be declared if both p-values for the tests of the individual hypotheses were \< 0.05.|LS Mean Difference|-6.64|STANDARD_ERROR_OF_MEAN|4.383||0.133|TWO_SIDED|95.0|-15.34|2.06||Testing was conducted in a hierarchical manner such that the comparison of etokimab Q4W versus placebo was conducted first. If the results of this comparison were statistically significant, the etokimab Q8W treatment arm would be compared to placebo.|General linear MMRM|||A general linear mixed effects model with repeated measures (MMRM) was used including the change from Baseline in SNOT-22 as dependent variable; treatment group, stratification factor, time (Weeks 4, 8, 12, and 16), treatment by stratification factor, and treatment by time interaction as fixed effect factors; Baseline SNOT-22 as covariate; and subject as random effect.||2.06|-15.34|0.1330
72460640|NCT03614923|144444183|SUPERIORITY|Statistical significance for the co-primary efficacy endpoints was to be declared if both p-values for the tests of the individual hypotheses were \< 0.05.|LS Mean Difference|-2.01|STANDARD_ERROR_OF_MEAN|4.375||0.6464|TWO_SIDED|95.0|-10.7|6.67||Testing was conducted in a hierarchical manner such that the comparison of etokimab Q4W versus placebo was conducted first. If the results of this comparison were statistically significant, the etokimab Q8W treatment arm would be compared to placebo.|General linear MMRM|||A general linear mixed effects model with repeated measures (MMRM) was used including the change from Baseline in SNOT-22 as dependent variable; treatment group, stratification factor, time (Weeks 4, 8, 12, and 16), treatment by stratification factor, and treatment by time interaction as fixed effect factors; Baseline SNOT-22 as covariate; and subject as random effect.||6.67|-10.70|0.6464
72460641|NCT00125619|144444187|SUPERIORITY_OR_OTHER|||||||0.72|||||||Wilcoxon (Mann-Whitney)|||Between group comparison of Robot (Lokomat) vs. Manual (therapist-assisted) training.||||0.72
72460642|NCT00125619|144444187|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Wilcoxon Signed Ranks|||Within group test for change pre- vs. post-training due to Robot (Lokomat) training.||||<.05
72460643|NCT00125619|144444187|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks|||Within group test for change pre- vs. post-training due to Manual (Therapist Assisted) training.||||>.05
72460644|NCT00125619|144444188|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||Between-groups comparison of Robot vs. Manual training.||||>0.05
72460645|NCT00125619|144444188|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks|||Within groups comparison (pre- vs. post-treatment) due to Manual (therapist-assisted) treatment.||||>.05
72501317|NCT00733902|144532359|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.44|STANDARD_ERROR_OF_MEAN|0.09|<|0.001|TWO_SIDED|95.0|-0.63|-0.26|||ANCOVA|||Change at Week 4: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.26|-0.63|<0.001
72501318|NCT00733902|144532359|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.46|STANDARD_ERROR_OF_MEAN|0.09|<|0.001|TWO_SIDED|95.0|-0.64|-0.28|||ANCOVA|||Change at Week 4: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.28|-0.64|<0.001
72501319|NCT00733902|144532359|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.57|STANDARD_ERROR_OF_MEAN|0.09|<|0.001|TWO_SIDED|95.0|-0.76|-0.39|||ANCOVA|||Change at Week 4: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.39|-0.76|<0.001
72501320|NCT00733902|144532359|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.35|STANDARD_ERROR_OF_MEAN|0.09|<|0.001|TWO_SIDED|95.0|-0.53|-0.16|||ANCOVA|||Change at Week 8: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.16|-0.53|<0.001
72501321|NCT00733902|144532359|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.36|STANDARD_ERROR_OF_MEAN|0.09|<|0.001|TWO_SIDED|95.0|-0.54|-0.17|||ANCOVA|||Change at Week 8: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.17|-0.54|<0.001
72501322|NCT00733902|144532359|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.67|STANDARD_ERROR_OF_MEAN|0.09|<|0.001|TWO_SIDED|95.0|-0.85|-0.49|||ANCOVA|||Change at Week 8: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.49|-0.85|<0.001
72563412|NCT00442546|144658173|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|12.941|STANDARD_ERROR_OF_MEAN|2.15||0.0018||95.0|7.414|18.468|||ANOVA||Mean difference (final values) = Least squares mean difference|120 hours||18.468|7.414|0.0018
72460646|NCT00125619|144444188|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Wilcoxon Signed Ranks|||Within-groups comparison of pre- vs. post-treatment effects for Robot (Lokomat) training.||||<.05
72460647|NCT00125619|144444189|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||Between-groups comparison of robot vs. manual training.||||>.05
72460648|NCT00125619|144444189|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks|||Within group comparison of pre- vs. post-treatment effects for manual training.||||>.05
72460649|NCT00125619|144444189|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Wilcoxon signed ranks|||Within group comparison of pre- vs. post-treatment effects of robot training.||||>.05
72460650|NCT00125619|144444190|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||Between groups comparison of effects of robot vs. manual training.||||>.05
72501323|NCT00733902|144532359|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.44|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.63|-0.25|||ANCOVA|||Change at Week 12: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.25|-0.63|<0.001
72501324|NCT00733902|144532359|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.38|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.57|-0.19|||ANCOVA|||Change at Week 12: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.19|-0.57|<0.001
72460651|NCT00125619|144444190|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks|||Within groups comparison of pre- vs. post-treatment effects of manual training.||||>.05
72460652|NCT00125619|144444190|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Wilcoxon Signed Ranks|||Within group comparison of pre- vs. post-training effects of robot training.||||<.05
72501325|NCT00733902|144532359|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.61|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.8|-0.42|||ANCOVA|||Change at Week 12: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.42|-0.80|<0.001
72460653|NCT00125619|144444191|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||Between groups comparison of robot vs. manual training.||||>.05
72460654|NCT00125619|144444191|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||Within groups comparison for pre- vs. post-training effects of manual training.||||>.05
72460655|NCT00125619|144444191|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||Within group comparison for pre- vs. post-training effects of robot training.||||>.05
72460656|NCT00125619|144444192|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||Between groups comparison of robot vs. manual training.||||>.05
72501326|NCT00733902|144532359|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.1||0.035|TWO_SIDED|95.0|-0.42|-0.02|||ANCOVA|||Change at Week 24: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.02|-0.42|0.035
72501327|NCT00733902|144532359|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.1||0.125|TWO_SIDED|95.0|-0.36|0.04|||ANCOVA|||Change at Week 24: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||0.04|-0.36|0.125
72460657|NCT00125619|144444192|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks|||Within group comparison of pre- vs. post-training effects of manual training.||||>.05
72563413|NCT00442546|144658173|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|17.941|STANDARD_ERROR_OF_MEAN|3.533||0.0038||95.0|8.859|27.023|||ANOVA||Mean difference (final values) = Least squares mean difference|120 hours||27.023|8.859|0.0038
72563414|NCT00442546|144658173|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.125|STANDARD_ERROR_OF_MEAN|2.115||0.5953||95.0|-3.045|5.296|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2||5.296|-3.045|0.5953
72563415|NCT00442546|144658173|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.331|STANDARD_ERROR_OF_MEAN|2.172||0.1267||95.0|-0.952|7.613|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2||7.613|-0.952|0.1267
72563416|NCT00442546|144658173|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.617|STANDARD_ERROR_OF_MEAN|2.339||0.2647||95.0|-1.997|7.231|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4||7.231|-1.997|0.2647
72563417|NCT00442546|144658173|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.771|STANDARD_ERROR_OF_MEAN|2.421||0.0181||95.0|0.995|10.548|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4||10.548|0.995|0.0181
72563418|NCT00442546|144658173|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.374|STANDARD_ERROR_OF_MEAN|2.299||0.5507||95.0|-3.161|5.91|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET||5.910|-3.161|0.5507
72563419|NCT00442546|144658173|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.404|STANDARD_ERROR_OF_MEAN|2.393||0.3164||95.0|-2.317|7.124|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET||7.124|-2.317|0.3164
72563420|NCT00442546|144658174|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4365||95.0|||||Log Rank|||||||0.4365
72563421|NCT00442546|144658174|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4023||95.0|||||Log Rank|||||||0.4023
72563422|NCT00442546|144658175|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4024||95.0|||||Log Rank|||||||0.4024
72563423|NCT00442546|144658175|SUPERIORITY_OR_OTHER_LEGACY|||||||0.191||95.0|||||Log Rank|||||||0.1910
72563424|NCT00442546|144658176|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.347|STANDARD_ERROR_OF_MEAN|2.497||0.3483||95.0|-2.573|7.268|||ANOVA||Mean difference (final values) = Least squares mean difference|Discharge||7.268|-2.573|0.3483
72563425|NCT00442546|144658176|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.155|STANDARD_ERROR_OF_MEAN|2.498||0.2078||95.0|-1.766|8.077|||ANOVA||Mean difference (final values) = Least squares mean difference|Discharge||8.077|-1.766|0.2078
72563426|NCT00442546|144658176|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.126|STANDARD_ERROR_OF_MEAN|6.436||0.4299||95.0|-7.836|18.088|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2||18.088|-7.836|0.4299
72563427|NCT00442546|144658176|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.146|STANDARD_ERROR_OF_MEAN|6.726||0.4482||95.0|-8.4|18.693|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2||18.693|-8.400|0.4482
72563428|NCT00442546|144658176|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.036|STANDARD_ERROR_OF_MEAN|4.426||0.6472||95.0|-6.818|10.89|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4||10.890|-6.818|0.6472
72563429|NCT00442546|144658176|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.156|STANDARD_ERROR_OF_MEAN|4.642||0.4992||95.0|-6.129|12.442|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4||12.442|-6.129|0.4992
72563430|NCT00442546|144658176|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.656|STANDARD_ERROR_OF_MEAN|5.149||0.6072||95.0|-7.578|12.891|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET||12.891|-7.578|0.6072
72563431|NCT00442546|144658176|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.963|STANDARD_ERROR_OF_MEAN|4.906||0.3146||95.0|-4.789|14.714|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET||14.714|-4.789|0.3146
72563432|NCT00442546|144658177|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.177|STANDARD_ERROR_OF_MEAN|2.326||0.0739||95.0|-0.407|8.76|||ANOVA||Mean difference (final values) = Least squares mean difference|Discharge||8.760|-0.407|0.0739
72392625|NCT01218204|144292587|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.598|||||TWO_SIDED|95.0|-21.784|20.5888|||||Statistical analysis was performed using LS mean value of Atorvastatin|Atorvastatin 10 mg + GSK1292263 300 mg vs Placebo: Apolipoprotein A1||20.5888|-21.7840|
72460658|NCT00125619|144444192|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Wilcoxon Signed Ranks|||Within group comparison of pre- vs. post-treatment effects of robot training.||||<.05
72392626|NCT01218204|144292587|SUPERIORITY_OR_OTHER||Mean Difference (Net)|11.906|||||TWO_SIDED|95.0|-9.3489|33.1602|||||Statistical analysis was performed using LS mean value of Atorvastatin|Atorvastatin 10 mg + GSK1292263 800 mg vs Placebo: Apolipoprotein A1||33.1602|-9.3489|
72392627|NCT01218204|144292587|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.671|||||TWO_SIDED|95.0|-16.9957|24.3384|||||Statistical analysis was performed using LS mean value of Atorvastatin|Atorvastatin 10 mg + Ezetimibe 10 mg vs Placebo: Apolipoprotein A1||24.3384|-16.9957|
72392628|NCT01218204|144292587|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.618|||||TWO_SIDED|95.0|-28.2069|37.4425|||||Statistical analysis was performed using LS mean value of Atorvastatin|Atorvastatin 80 mg + GSK1292263 800 mg vs Placebo: Apolipoprotein A1||37.4425|-28.2069|
72392629|NCT01218204|144292587|SUPERIORITY_OR_OTHER||Mean Difference (Net)|7.713|||||TWO_SIDED|95.0|-17.0405|39.8527|||||Statistical analysis was performed using LS mean value of GSK1292263|GSK1292263 100 mg vs Placebo: Apolipoprotein A1||39.8527|-17.0405|
72392630|NCT01218204|144292587|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.934|||||TWO_SIDED|95.0|-21.0153|31.5504|||||Statistical analysis was performed using LS mean value of GSK1292263|GSK1292263 300 mg vs Placebo: Apolipoprotein A1||31.5504|-21.0153|
72392631|NCT01218204|144292587|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.466|||||TWO_SIDED|95.0|-23.7517|24.7608|||||Statistical analysis was performed using LS mean value of GSK1292263|GSK1292263 800 mg vs Placebo: Apolipoprotein A1||24.7608|-23.7517|
72392632|NCT01218204|144292587|SUPERIORITY_OR_OTHER||Mean Difference (Net)|13.743|||||TWO_SIDED|95.0|-3.246|33.7161|||||Statistical analysis was performed using LS mean value of Atorvastatin|Atorvastatin 10 mg + GSK1292263 100 mg vs Placebo: Apolipoprotein B100||33.7161|-3.2460|
72460659|NCT00125619|144444193|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||Between groups comparison of robot vs. manual training.||||>.05
72392633|NCT01218204|144292587|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-7.428|||||TWO_SIDED|95.0|-21.3243|8.9224|||||Statistical analysis was performed using LS mean value Atorvastatin|Atorvastatin 10 mg + GSK1292263 300 mg vs Placebo: Apolipoprotein B100||8.9224|-21.3243|
72392634|NCT01218204|144292587|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-13.96|||||TWO_SIDED|95.0|-26.8137|1.1513|||||Statistical analysis was performed using LS mean value Atorvastatin|Atorvastatin 10 mg + GSK1292263 800 mg vs Placebo: Apolipoprotein B100||1.1513|-26.8137|
72392635|NCT01218204|144292587|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.903|||||TWO_SIDED|95.0|-16.6557|13.1191|||||Statistical analysis was performed using LS mean value Atorvastatin|Atorvastatin 10 mg + Ezetimibe 10 mg vs Placebo: Apolipoprotein B100||13.1191|-16.6557|
72392636|NCT01218204|144292587|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-28.231|||||TWO_SIDED|95.0|-45.1045|-11.3579|||||Statistical analysis was performed using LS mean value Atorvastatin|Atorvastatin 80 mg + GSK1292263 800 mg vs Placebo: Apolipoprotein B100||-11.3579|-45.1045|
72392637|NCT01218204|144292587|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-6.1|||||TWO_SIDED|95.0|-23.5021|11.3014|||||Statistical analysis was performed using LS mean value of GSK1292263|GSK1292263 100 mg vs Placebo: Apolipoprotein B100||11.3014|-23.5021|
72392638|NCT01218204|144292587|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-8.49|||||TWO_SIDED|95.0|-25.2721|8.2918|||||Statistical analysis was performed using LS mean value of GSK1292263|GSK1292263 300 mg vs Placebo: Apolipoprotein B100||8.2918|-25.2721|
72392639|NCT01218204|144292587|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-9.687|||||TWO_SIDED|95.0|-26.0247|6.6498|||||Statistical analysis was performed using LS mean value of GSK1292263|GSK1292263 800 mg vs Placebo: Apolipoprotein B100||6.6498|-26.0247|
72392640|NCT01218204|144292588|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-19.471|||||TWO_SIDED|95.0|-47.9323|3.202|||||Statistical analysis was performed using LS mean value Atorvastatin|||3.2020|-47.9323|
72460660|NCT00125619|144444193|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Wilcoxon Signed Ranks|||Within group comparison of pre- vs. post-training effects of manual training.||||<.05
72460661|NCT00125619|144444193|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Wilcoxon Signed Ranks|||Within group comparison of pre- vs. post-treatment effects of robot training.||||<.05
72392641|NCT01218204|144292588|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.91|||||TWO_SIDED|95.0|-38.1027|25.3126|||||Statistical analysis was performed using LS mean value Atorvastatin|||25.3126|-38.1027|
72392642|NCT01218204|144292588|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-25.985|||||TWO_SIDED|95.0|-45.5492|1.8605|||||Statistical analysis was performed using LS mean value Atorvastatin|||1.8605|-45.5492|
72392643|NCT01218204|144292588|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-16.697|||||TWO_SIDED|95.0|-45.0846|13.3024|||||Statistical analysis was performed using LS mean value Atorvastatin|||13.3024|-45.0846|
72392644|NCT01218204|144292588|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-6.036|||||TWO_SIDED|95.0|-27.2281|15.1569|||||Statistical analysis was performed using LS mean value of Atorvastatin|||15.1569|-27.2281|
72392645|NCT01218204|144292588|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.198|||||TWO_SIDED|95.0|-24.2901|32.6057|||||Statistical analysis was performed using LS mean value of GSK1292263|||32.6057|-24.2901|
72392646|NCT01218204|144292588|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-22.117|||||TWO_SIDED|95.0|-40.4767|1.906|||||Statistical analysis was performed using LS mean value of GSK1292263|||1.9060|-40.4767|
72392647|NCT01218204|144292588|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-32.798|||||TWO_SIDED|95.0|-48.3842|-12.5064|||||Statistical analysis was performed using LS mean value of GSK1292263|||-12.5064|-48.3842|
72392648|NCT01218204|144292589|SUPERIORITY_OR_OTHER||Mean Difference (Net)|5.101|||||TWO_SIDED|95.0|-4.5469|14.7495|||||Statistical analysis was performed using LS mean value of Atorvastatin|For HDLc||14.7495|-4.5469|
72392649|NCT01218204|144292589|SUPERIORITY_OR_OTHER||Mean Difference (Net)|12.273|||||TWO_SIDED|95.0|2.5937|21.9532|||||Statistical analysis was performed using LS mean value of Atorvastatin|Fo HDLc||21.9532|2.5937|
72460662|NCT00168805|144444221|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority Analysis with NI margin 9.2%. This results from the null-hypotheses of non-inferiority testing, where the absolute risk difference has to be below 9.2%. Non-inferiority can only be shown with CI.|Risk Difference (Percentage)|-1.3||||0.6648||95.0|-7.3|4.6||p-value is for superiority testing|Normal approximation|Normal approximation of independent binomial distribution without stratification||Risk difference versus Enoxaparin||4.6|-7.3|0.6648
72392650|NCT01218204|144292589|SUPERIORITY_OR_OTHER||Mean Difference (Net)|28.833|||||TWO_SIDED|95.0|18.955|38.7102|||||Statistical analysis was performed using LS mean value of Atorvastatin|For HDLc||38.7102|18.9550|
72392651|NCT01218204|144292589|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.701|||||TWO_SIDED|95.0|-5.5562|12.9578|||||Statistical analysis was performed using LS mean value of Atorvastatin|For HDLc||12.9578|-5.5562|
72392652|NCT01218204|144292589|SUPERIORITY_OR_OTHER||Mean Difference (Net)|20.946|||||TWO_SIDED|95.0|8.612|33.281|||||Statistical analysis was performed using LS mean value of Atorvastatin|For HDLc||33.2810|8.6120|
72392653|NCT01218204|144292589|SUPERIORITY_OR_OTHER||Median Difference (Net)|10.561|||||TWO_SIDED|95.0|-0.9675|22.0898|||||Statistical analysis was performed using LS mean value of GSK1292263|For HDLc||22.0898|-0.9675|
72392654|NCT01218204|144292589|SUPERIORITY_OR_OTHER||Mean Difference (Net)|11.122|||||TWO_SIDED|95.0|-0.2902|22.5351|||||Statistical analysis was performed using LS mean value of GSK1292263|For HDLc||22.5351|-0.2902|
72392655|NCT01218204|144292589|SUPERIORITY_OR_OTHER||Mean Difference (Net)|20.689|||||TWO_SIDED|95.0|9.7527|31.6262|||||Statistical analysis was performed using LS mean value of GSK1292263|For HDLc||31.6262|9.7527|
72392656|NCT01218204|144292589|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.549|||||TWO_SIDED|95.0|-18.775|9.6768|||||Statistical analysis was performed using LS mean value of Atorvastatin|For LDLc||9.6768|-18.7750|
72460663|NCT00168805|144444221|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority Analysis with NI margin 9.2%. This results from the null-hypotheses of non-inferiority testing, where the absolute risk difference has to be below 9.2%. Non-inferiority can only be shown with CI.|Risk Difference (Percentage)|2.8||||0.3553||95.0|-3.1|8.7||p-value is for superiority testing|Normal approximation|Normal approximation of independent binomial distribution without stratification||Risk difference versus Enoxaparin||8.7|-3.1|0.3553
72620990|NCT00834587|144772951|NON_INFERIORITY_OR_EQUIVALENCE|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Test/Ref Ratio of LS Means x 100|99.2||||||90.0|96.5|102.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||102.0|96.5|
72392657|NCT01218204|144292589|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-10.337|||||TWO_SIDED|95.0|-24.4549|3.7803|||||Statistical analysis was performed using LS mean value of Atorvastatin|For LDLc||3.7803|-24.4549|
72392658|NCT01218204|144292589|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-21.317|||||TWO_SIDED|95.0|-36.0144|-6.619|||||Statistical analysis was performed using LS mean value of Atorvastatin|For LDLc||-6.6190|-36.0144|
72392659|NCT01218204|144292589|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-20.173|||||TWO_SIDED|95.0|-34.271|-6.0755|||||Statistical analysis was performed using LS mean value of Atorvastatin|For LDLc||-6.0755|-34.2710|
72392660|NCT01218204|144292589|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-25.472|||||TWO_SIDED|95.0|-49.3385|-8.1558|||||Statistical analysis was performed using LS mean value of Atorvastatin|For LDLc||-8.1558|-49.3385|
72392661|NCT01218204|144292589|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-12.128|||||TWO_SIDED|95.0|-23.3049|-0.9514|||||Statistical analysis was performed using LS mean value of GSK1292263|For LDLc||-0.9514|-23.3049|
72392662|NCT01218204|144292589|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-15.798|||||TWO_SIDED|95.0|-27.1364|-4.4589|||||Statistical analysis was performed using LS mean value of GSK1292263|For LDLc||-4.4589|-27.1364|
72392663|NCT01218204|144292589|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-21.789|||||TWO_SIDED|95.0|-32.3413|-11.2372|||||Statistical analysis was performed using LS mean value of GSK1292263|For LDLc||-11.2372|-32.3413|
72392664|NCT01218204|144292589|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-22.498|||||TWO_SIDED|95.0|-38.446|-2.4169|||||Statistical analysis was performed using LS mean value of Atorvastatin|For Triglycerides||-2.4169|-38.4460|
72460664|NCT00168805|144444222|SUPERIORITY_OR_OTHER||Risk Difference (Percentage)|-1.0||||0.376||95.0|-3.1|1.2|||Normal approximation|Normal approximation of independent binomial distribution without stratification||Risk difference versus Enoxaparin||1.2|-3.1|0.3760
72392665|NCT01218204|144292589|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-23.781|||||TWO_SIDED|95.0|-39.1603|-4.513|||||Statistical analysis was performed using LS mean value of Atorvastatin|For Triglycerides||-4.5130|-39.1603|
72392666|NCT01218204|144292589|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-39.923|||||TWO_SIDED|95.0|-52.3394|-24.2717|||||Statistical analysis was performed using LS mean value of Atorvastatin|For Triglycerides||-24.2717|-52.3394|
72392667|NCT01218204|144292589|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-17.444|||||TWO_SIDED|95.0|-33.502|2.491|||||Statistical analysis was performed using LS mean value of Atorvastatin|For Triglycerides||2.4910|-33.5020|
72392668|NCT01218204|144292589|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-21.781|||||TWO_SIDED|95.0|-40.296|-3.2667|||||Statistical analysis was performed using LS mean value of Atorvastatin|For Triglycerides||-3.2667|-40.2960|
72392669|NCT01218204|144292589|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-21.421|||||TWO_SIDED|95.0|-38.3519|-4.4911|||||Statistical analysis was performed using LS mean value of GSK1292263|For Triglycerides||-4.4911|-38.3519|
72392670|NCT01218204|144292589|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-46.361|||||TWO_SIDED|95.0|-63.465|-29.2561|||||Statistical analysis was performed using LS mean value of GSK1292263|For Triglycerides||-29.2561|-63.4650|
72392671|NCT01218204|144292589|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-54.843|||||TWO_SIDED|95.0|-70.7854|-38.9007|||||Statistical analysis was performed using LS mean value of GSK1292263|For Triglycerides||-38.9007|-70.7854|
72392672|NCT01218204|144292589|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-9.756|||||TWO_SIDED|95.0|-21.7561|2.2448|||||Statistical analysis was performed using LS mean value of Atorvastatin|For Non-HDLc||2.2448|-21.7561|
72392673|NCT01218204|144292589|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-14.014|||||TWO_SIDED|95.0|-25.7497|-2.2787|||||Statistical analysis was performed using LS mean value of Atorvastatin|For Non-HDLc||-2.2787|-25.7497|
72392674|NCT01218204|144292589|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-27.675|||||TWO_SIDED|95.0|-39.8454|-15.5045|||||Statistical analysis was performed using LS mean value of Atorvastatin|For Non-HDLc||-15.5045|-39.8454|
72392675|NCT01218204|144292589|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-20.937|||||TWO_SIDED|95.0|-32.6057|-9.269|||||Statistical analysis was performed using LS mean value of Atorvastatin|For Non-HDLc||-9.2690|-32.6057|
72460665|NCT00168805|144444222|SUPERIORITY_OR_OTHER||Risk Difference (Percentage)|0.3||||0.8151||95.0|-2.0|2.6|||Normal approximation|Normal approximation of independent binomial distribution without stratification||Risk difference versus Enoxaparin||2.6|-2.0|0.8151
72460666|NCT00168805|144444223|SUPERIORITY_OR_OTHER||Risk Difference (Percentage)|-0.8||||0.4715||95.0|-2.8|1.3|||Normal approximation|Normal approximation of independent binomial distribution without stratification||Risk difference versus Enoxaparin||1.3|-2.8|0.4715
72460667|NCT00168805|144444223|SUPERIORITY_OR_OTHER||Risk Difference (Percentage)|0.1||||0.9325||95.0|-2.1|2.3|||Normal approximation|Normal approximation of independent binomial distribution without stratification||Risk difference versus Enoxaparin||2.3|-2.1|0.9325
72460668|NCT00168805|144444224|SUPERIORITY_OR_OTHER||Risk Difference (Percentage)|-1.4||||0.6463||95.0|-7.3|4.5|||Normal approximation|Normal approximation of independent binomial distribution without stratification||Risk difference versus Enoxaparin||4.5|-7.3|0.6463
72460669|NCT00168805|144444224|SUPERIORITY_OR_OTHER||Risk Difference (Percentage)|2.7||||0.374||95.0|-3.2|8.6|||Normal approximation|Normal approximation of independent binomial distribution without stratification||Risk difference versus Enoxaparin||8.6|-3.2|0.3740
72460670|NCT00168805|144444225|SUPERIORITY_OR_OTHER|||||||0.0385||95.0|||||Fisher Exact|||Comparison versus Enoxaparin||||0.0385
72460671|NCT00168805|144444225|SUPERIORITY_OR_OTHER|||||||0.1414||95.0|||||Fisher Exact|||Comparison versus Enoxaparin||||0.1414
72460672|NCT00168805|144444226|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|||Comparison versus Enoxaparin||||1.0000
72460673|NCT00168805|144444226|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|||Comparison versus Enoxaparin||||1.0000
72460674|NCT00168805|144444227|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|||Comparison versus Enoxaparin||||1.0000
72370551|NCT00488683|144251633|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|0.14||||0.57||95.0|||||Parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Pearson correlation coefficient between memory B cells one month after primary vaccination and hSBA titers rise from pre-booster to one month after booster vaccination for the serogroup A||||0.57
72460675|NCT00168805|144444227|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|||Comparison versus Enoxaparin||||1.0000
72460676|NCT00168805|144444229|SUPERIORITY_OR_OTHER|||||||0.8209||95.0|||||Fisher Exact|||Comparison versus Enoxaparin||||0.8209
72460677|NCT00168805|144444229|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|||Comparison versus Enoxaparin||||1.0000
72460678|NCT01114217|144444233|OTHER||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
72501328|NCT00733902|144532359|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.38|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.58|-0.18|||ANCOVA|||Change at Week 24: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.18|-0.58|<0.001
72501329|NCT00733902|144532360|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.32|STANDARD_ERROR_OF_MEAN|0.09|<|0.001|TWO_SIDED|95.0|-0.49|-0.14|||ANCOVA|||Change at Week 2: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.14|-0.49|<0.001
72370552|NCT00488683|144251633|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|0.65||||0.001||95.0|||||Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccination and hSBA titers rise from pre-booster to one month after booster vaccination for the serogroup C||||0.001
72370553|NCT00488683|144251633|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|0.31||||0.11||95.0|||||Parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Pearson correlation coefficient between memory B cells one month after primary vaccination and hSBA titers rise from pre-booster to one month after booster vaccination for the serogroup C||||0.11
72370554|NCT00488683|144251633|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|-0.02||||0.94||95.0|||||Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccination and hSBA titers rise from pre-booster to one month after booster vaccination for the serogroup W-135||||0.94
72370555|NCT00488683|144251633|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|-0.0003||||1||95.0|||||Parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Pearson correlation coefficient between memory B cells one month after primary vaccination and hSBA titers rise from pre-booster to one month after booster vaccination for the serogroup W-135||||1.00
72370556|NCT00488683|144251633|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|0.004||||1||95.0|||||Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccination and hSBA titers rise from pre-booster to one month after booster vaccination for the serogroup Y||||1.00
72370557|NCT00488683|144251633|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|-0.3||||0.37||95.0|||||Parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Pearson correlation coefficient between memory B cells one month after primary vaccination and hSBA titers rise from pre-booster to one month after booster vaccination for the serogroup Y||||0.37
72370558|NCT00488683|144251633|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.52||||0.09||95.0|||||Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccination and hSBA titers rise from pre-booster to one month after booster vaccination for the serogroup A||||0.09
72370559|NCT00488683|144251633|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.21||||0.4||95.0|||||Non-parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Spearman correlation coefficient between memory B cells one month after primary vaccination and hSBA titers rise from pre-booster to one month after booster vaccination for the serogroup A||||0.40
72370560|NCT00488683|144251633|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.28||||0.2||95.0|||||Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccination and hSBA titers rise from pre-booster to one month after booster vaccination for the serogroup C||||0.20
72370561|NCT00488683|144251633|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.41||||0.03||95.0|||||Non-parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Spearman correlation coefficient between memory B cells one month after primary vaccination and hSBA titers rise from pre-booster to one month after booster vaccination for the serogroup C||||0.03
72370562|NCT00488683|144251633|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.48||||0.07||95.0|||||Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccination and hSBA titers rise from pre-booster to one month after booster vaccination for the serogroup W-135||||0.07
72370563|NCT00488683|144251633|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.22||||0.3||95.0|||||Non-parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Spearman correlation coefficient between memory B cells one month after primary vaccination and hSBA titers rise from pre-booster to one month after booster vaccination for the serogroup W-135||||0.30
72460679|NCT01183013|144444240|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.17||||0.1571||95.0|-0.41|0.07||The model includes fixed effects for treatment, continuous baseline HbA1c, prior anti-diabetic medication and country.|ANCOVA|||Treatment comparisons are for fixed dose combination versus monotherapy.||0.07|-0.41|0.1571
72620991|NCT00834587|144772952|NON_INFERIORITY_OR_EQUIVALENCE|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Test/Ref Ratio of LS Means x 100|99.1||||||90.0|96.5|101.8|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||101.8|96.5|
72620992|NCT02457546|144772998|NON_INFERIORITY|"The statistical hypothesis for testing the treatment difference was presented as follows:~H0: Δ ≤ -0.10 tested against the alternative hypothesis Ha: Δ \> -0.10. where:~* Δ is the difference between the success rates of Experimental (Evicel®) and Control (DuraSeal™) (Experimental minus Control)~* -0.10 is the non-inferiority difference PC is the proportion of success in DuraSeal™ Control subjects and PE is the proportion of success in EVICEL® subjects."|Difference in Success Rates|6.3|||||TWO_SIDED|95.0|-1.8|14.4||||||||14.4|-1.8|
72620993|NCT01537432|144773067|SUPERIORITY_OR_OTHER||difference in proportions|0.565|||<|0.001|TWO_SIDED|95.0|0.363|0.768|||Fisher Exact|||||0.768|0.363|<0.001
72620994|NCT03523585|144773079|SUPERIORITY||Hazard Ratio (HR)|0.3589|||<|1e-06|TWO_SIDED|95.0|0.284|0.4535||Stratified Log-rank p-value|Log Rank|p value based on log-rank stratified by hormone receptor status, prior treatment with pertuzumab, and history of visceral disease, as defined by IXRS|Hazard Ratio based on stratified Cox proportional hazards model with stratification factors: hormone receptor status, prior treatment with pertuzumab, and history of visceral disease, as defined by the IXRS.|||0.4535|0.2840|<0.000001
72620995|NCT03523585|144773080|SUPERIORITY||Hazard Ratio (HR)|0.6575||||0.0021|TWO_SIDED|95.0|0.5023|0.8605||Stratified Log-rank p-value|Log Rank|p value based on log-rank stratified by hormone receptor status, prior treatment with pertuzumab, and history of visceral disease, as defined by IXRS|Hazard Ratio based on stratified Cox proportional hazards model with stratification factors: hormone receptor status, prior treatment with pertuzumab, and history of visceral disease, as defined by the IXRS.|||0.8605|0.5023|0.0021
72620996|NCT03523585|144773081|SUPERIORITY||||||<|0.0001||||||Cochran-Mantel-Haenszel test adjusted for stratification factors: hormone receptor status, prior treatment with pertuzumab, and history of visceral disease, as defined by the IXRS.|Cochran-Mantel-Haenszel|||Statistical Analysis for BICR Assessment||||<0.0001
72370564|NCT00488683|144251633|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.26||||0.74||95.0|||||Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccination and hSBA titers rise from pre-booster to one month after booster vaccination for the serogroup Y||||0.74
72460680|NCT01183013|144444240|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.37||||0.0016|TWO_SIDED|95.0|-0.6|-0.14|||ANCOVA|The model includes fixed effects for treatment, continuous baseline HbA1c, prior anti-diabetic medication and country.||Treatment comparisons are for fixed dose combination versus monotherapy.||-0.14|-0.60|0.0016
72501330|NCT00733902|144532360|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.09||0.486|TWO_SIDED|95.0|-0.24|0.11|||ANCOVA|||Change at Week 2: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||0.11|-0.24|0.486
72370565|NCT00488683|144251633|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|-0.378||||0.25||95.0|||||Non-parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Spearman correlation coefficient between memory B cells one month after primary vaccination and hSBA titers rise from pre-booster to one month after booster vaccination for the serogroup Y||||0.25
72501331|NCT00733902|144532360|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.24|STANDARD_ERROR_OF_MEAN|0.09||0.008|TWO_SIDED|95.0|-0.42|-0.06|||ANCOVA|||Change at Week 2: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.06|-0.42|0.008
72501332|NCT00733902|144532360|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.46|STANDARD_ERROR_OF_MEAN|0.09|<|0.001|TWO_SIDED|95.0|-0.64|-0.28|||ANCOVA|||Change at Week 4: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.28|-0.64|<0.001
72460681|NCT01183013|144444240|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.41||||0.0006|TWO_SIDED|95.0|-0.64|-0.18|||ANCOVA|The model includes fixed effects for treatment, continuous baseline HbA1c, prior anti-diabetic medication and country.||Treatment comparisons are for fixed dose combination versus monotherapy.||-0.18|-0.64|0.0006
72501333|NCT00733902|144532360|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.44|STANDARD_ERROR_OF_MEAN|0.09|<|0.001|TWO_SIDED|95.0|-0.62|-0.26|||ANCOVA|||Change at Week 4: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.26|-0.62|<0.001
72501334|NCT00733902|144532360|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.57|STANDARD_ERROR_OF_MEAN|0.09|<|0.001|TWO_SIDED|95.0|-0.75|-0.39|||ANCOVA|||Change at Week 4: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.39|-0.75|<0.001
72501335|NCT00733902|144532360|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.35|STANDARD_ERROR_OF_MEAN|0.09|<|0.001|TWO_SIDED|95.0|-0.53|-0.16|||ANCOVA|||Change at Week 8: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.16|-0.53|<0.001
72501336|NCT00733902|144532360|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.09|<|0.001|TWO_SIDED|95.0|-0.58|-0.22|||ANCOVA|||Change at Week 8: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.22|-0.58|<0.001
72620997|NCT03523585|144773081|SUPERIORITY||||||<|0.0001||||||Cochran-Mantel-Haenszel test adjusted for stratification factors: hormone receptor status, prior treatment with pertuzumab, and history of visceral disease, as defined by the IXRS.|Cochran-Mantel-Haenszel|||Statistical Analysis for Investigator Assessment||||<0.0001
72620998|NCT03523585|144773083|SUPERIORITY||Hazard Ratio (HR)|0.2828|||<|1e-06|TWO_SIDED|95.0|0.227|0.3524||Stratified Log-rank p-value.|Log Rank|p value based on log-rank stratified by hormone receptor status, prior treatment with pertuzumab, and history of visceral disease, as defined by IXRS|Hazard Ratio based on stratified Cox proportional hazards model with stratification factors: hormone receptor status, prior treatment with pertuzumab, and history of visceral disease, as defined by the IXRS.|||0.3524|0.2270|<0.000001
72620999|NCT03704922|144773084|OTHER|||||||0.051|||||||Fisher Exact|||||||0.051
72460682|NCT01183013|144444240|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.44||||0.0003|TWO_SIDED|95.0|-0.67|-0.2|||ANCOVA|The model includes fixed effects for treatment, continuous baseline HbA1c, prior anti-diabetic medication and country.||Treatment comparisons are for fixed dose combination versus monotherapy.||-0.20|-0.67|0.0003
72460683|NCT01183013|144444240|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.68|||<|0.0001|TWO_SIDED|95.0|-0.91|-0.44|||ANCOVA|The model includes fixed effects for treatment, continuous baseline HbA1c, prior anti-diabetic medication and country.||Treatment comparisons are for fixed dose combination versus monotherapy.||-0.44|-0.91|<0.0001
72460684|NCT01183013|144444240|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.89|||<|0.0001|TWO_SIDED|95.0|-1.12|-0.66|||ANCOVA|The model includes fixed effects for treatment, continuous baseline HbA1c, prior anti-diabetic medication and country.||Treatment comparisons are for fixed dose combination versus monotherapy.||-0.66|-1.12|<0.0001
72460685|NCT01183013|144444241|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.246||||0.4639||95.0|0.692|2.242|||Regression, Logistic|A logistic regression model with terms for treatment, continuous HbA1c baseline, prior use of antidiabetic agents and country.||Treatment comparisons are for fixed dose combination versus monotherapy.||2.242|0.692|0.4639
72460686|NCT01183013|144444241|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.746||||0.0546||95.0|0.989|3.083|||Regression, Logistic|A logistic regression model with terms for treatment, continuous HbA1c baseline, prior use of antidiabetic agents and country.||Treatment comparisons are for fixed dose combination versus monotherapy.||3.083|0.989|0.0546
72460687|NCT01183013|144444241|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.903||||0.0254||95.0|1.083|3.345|||Regression, Logistic|A logistic regression model with terms for treatment, continuous HbA1c baseline, prior use of antidiabetic agents and country.||Treatment comparisons are for fixed dose combination versus monotherapy.||3.345|1.083|0.0254
72460688|NCT01183013|144444241|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.804||||0.0009||95.0|1.524|5.159|||Regression, Logistic|A logistic regression model with terms for treatment, continuous HbA1c baseline, prior use of antidiabetic agents and country.||Treatment comparisons are for fixed dose combination versus monotherapy.||5.159|1.524|0.0009
72460689|NCT01183013|144444241|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.429|||<|0.0001||95.0|2.947|10.001|||Regression, Logistic|A logistic regression model with terms for treatment, continuous HbA1c baseline, prior use of antidiabetic agents and country.||Treatment comparisons are for fixed dose combination versus monotherapy.||10.001|2.947|<0.0001
72460690|NCT01183013|144444241|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|9.614|||<|0.0001||95.0|5.187|17.821|||Regression, Logistic|A logistic regression model with terms for treatment, continuous HbA1c baseline, prior use of antidiabetic agents and country.||Treatment comparisons are for fixed dose combination versus monotherapy.||17.821|5.187|<0.0001
72460691|NCT01183013|144444242|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.126||||0.7359||95.0|0.565|2.243|||Regression, Logistic|A logistic regression model with terms for treatment, continuous HbA1c baseline, prior use of antidiabetic agents and country.||Treatment comparisons are for fixed dose combination versus monotherapy.||2.243|0.565|0.7359
72460692|NCT01183013|144444242|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.905||||0.0363||95.0|1.042|3.484|||Regression, Logistic|A logistic regression model with terms for treatment, continuous HbA1c baseline, prior use of antidiabetic agents and country.||Treatment comparisons are for fixed dose combination versus monotherapy.||3.484|1.042|0.0363
72460693|NCT01183013|144444242|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.269||||0.4039||95.0|0.726|2.217|||Regression, Logistic|A logistic regression model with terms for treatment, continuous HbA1c baseline, prior use of antidiabetic agents and country.||Treatment comparisons are for fixed dose combination versus monotherapy.||2.217|0.726|0.4039
72460694|NCT01183013|144444242|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.22||||0.0345||95.0|1.06|4.649|||Regression, Logistic|A logistic regression model with terms for treatment, continuous HbA1c baseline, prior use of antidiabetic agents and country.||Treatment comparisons are for fixed dose combination versus monotherapy.||4.649|1.060|0.0345
72501337|NCT00733902|144532360|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.71|STANDARD_ERROR_OF_MEAN|0.09|<|0.001|TWO_SIDED|95.0|-0.89|-0.52|||ANCOVA|||Change at Week 8: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.52|-0.89|<0.001
72501338|NCT00733902|144532360|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.09|<|0.001|TWO_SIDED|95.0|-0.59|-0.22|||ANCOVA|||Change at Week 12: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.22|-0.59|<0.001
72501339|NCT00733902|144532360|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.37|STANDARD_ERROR_OF_MEAN|0.09|<|0.001|TWO_SIDED|95.0|-0.55|-0.18|||ANCOVA|||Change at Week 12: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.18|-0.55|<0.001
72392676|NCT01218204|144292589|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-21.702|||||TWO_SIDED|95.0|-29.0346|-14.3696|||||Statistical analysis was performed using LS mean value of Atorvastatin|For Non-HDLc||-14.3696|-29.0346|
72460695|NCT01183013|144444242|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.58|||<|0.0001||95.0|2.263|9.266|||Regression, Logistic|A logistic regression model with terms for treatment, continuous HbA1c baseline, prior use of antidiabetic agents and country.||Treatment comparisons are for fixed dose combination versus monotherapy.||9.266|2.263|<0.0001
72460696|NCT01183013|144444242|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.066|||<|0.0001||95.0|2.53|10.145|||Regression, Logistic|A logistic regression model with terms for treatment, continuous HbA1c baseline, prior use of antidiabetic agents and country.||Treatment comparisons are for fixed dose combination versus monotherapy.||10.145|2.530|<0.0001
72460697|NCT01183013|144444243|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.09||||0.754||95.0|0.637|1.863|||Regression, Logistic|A logistic regression model with terms for treatment, continuous HbA1c baseline, prior use of antidiabetic agents and country.||Treatment comparisons are for fixed dose combination versus monotherapy.||1.863|0.637|0.7540
72460698|NCT01183013|144444243|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.707||||0.0506||95.0|0.999|2.918|||Regression, Logistic|A logistic regression model with terms for treatment, continuous HbA1c baseline, prior use of antidiabetic agents and country.||Treatment comparisons are for fixed dose combination versus monotherapy.||2.918|0.999|0.0506
72460699|NCT01183013|144444243|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.966||||0.0005|TWO_SIDED|95.0|1.604|5.485|||Regression, Logistic|A logistic regression model with terms for treatment, continuous HbA1c baseline, prior use of antidiabetic agents and country.||Treatment comparisons are for fixed dose combination versus monotherapy.||5.485|1.604|0.0005
72501340|NCT00733902|144532360|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.65|STANDARD_ERROR_OF_MEAN|0.09|<|0.001|TWO_SIDED|95.0|-0.83|-0.46|||ANCOVA|||Change at Week 12: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.46|-0.83|<0.001
72501341|NCT00733902|144532360|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.28|STANDARD_ERROR_OF_MEAN|0.1||0.004|TWO_SIDED|95.0|-0.47|-0.09|||ANCOVA|||Change at Week 16: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.09|-0.47|0.004
72501342|NCT00733902|144532360|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.36|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.55|-0.17|||ANCOVA|||Change at Week 16: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.17|-0.55|<0.001
72501343|NCT00733902|144532360|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.58|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.77|-0.39|||ANCOVA|||Change at Week 16: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.39|-0.77|<0.001
72501344|NCT00733902|144532360|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.1||0.09|TWO_SIDED|95.0|-0.37|0.03|||ANCOVA|||Change at Week 24: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||0.03|-0.37|0.090
72370566|NCT00488683|144251633|SUPERIORITY_OR_OTHER||R-square|0.69||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and hSBA titers rise from pre-booster to one month after booster vaccination for the serogroup A||||
72501345|NCT00733902|144532360|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.1||0.053|TWO_SIDED|95.0|-0.39|0.0|||ANCOVA|||Change at Week 24: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||0.00|-0.39|0.053
72501346|NCT00733902|144532360|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.7|-0.3|||ANCOVA|||Change at Week 24: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.30|-0.70|<0.001
72563433|NCT00442546|144658177|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.176|STANDARD_ERROR_OF_MEAN|2.327||0.074||95.0|-0.409|8.761|||ANOVA||Mean difference (final values) = Least squares mean difference|Discharge||8.761|-0.409|0.0740
72370567|NCT00488683|144251633|SUPERIORITY_OR_OTHER||R-square|0.02||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between memory B cells one month after primary vaccination and hSBA titers rise from pre-booster to one month after booster vaccination for the serogroup A||||
72370568|NCT00488683|144251633|SUPERIORITY_OR_OTHER||R-square|0.42||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and hSBA titers rise from pre-booster to one month after booster vaccination for the serogroup C||||
72370569|NCT00488683|144251633|SUPERIORITY_OR_OTHER||R-square|0.1||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between memory B cells one month after primary vaccination and hSBA titers rise from pre-booster to one month after booster vaccination for the serogroup C||||
72370570|NCT00488683|144251633|SUPERIORITY_OR_OTHER||R-square|0.0004||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and hSBA titers rise from pre-booster to one month after booster vaccination for the serogroup W-135||||
72370571|NCT00488683|144251633|SUPERIORITY_OR_OTHER||R-square|0.0||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between memory B cells one month after primary vaccination and hSBA titers rise from pre-booster to one month after booster vaccination for the serogroup W-135||||
72370572|NCT00488683|144251633|SUPERIORITY_OR_OTHER||R-square|0.0||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and hSBA titers rise from pre-booster to one month after booster vaccination for the serogroup Y||||
72370573|NCT00488683|144251633|SUPERIORITY_OR_OTHER||R-square|0.9||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between memory B cells one month after primary vaccination and hSBA titers rise from pre-booster to one month after booster vaccination for the serogroup Y||||
72370574|NCT00488683|144251633|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|-0.04||||0.86||95.0|||||Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccination and rise from pre-booster levels in serogroup specific IgG concentration one month after booster vaccination for the serogroup A||||0.86
72370575|NCT00488683|144251633|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|0.08||||0.7||95.0|||||Parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Pearson correlation coefficient between memory B cells one month after primary vaccination and rise from pre-booster levels in serogroup specific IgG concentration one month after booster vaccination for the serogroup A||||0.7
72370576|NCT00488683|144251633|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|-0.11||||0.58||95.0|||||Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccination and rise from pre-booster levels in serogroup specific IgG concentration one month after booster vaccination for the serogroup C||||0.58
72370577|NCT00488683|144251633|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|-0.13||||0.44||95.0|||||Parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Pearson correlation coefficient between memory B cells one month after primary vaccination and rise from pre-booster levels in serogroup specific IgG concentration one month after booster vaccination for the serogroup C||||0.44
72370578|NCT00488683|144251633|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|-0.07||||0.75||95.0|||||Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccination and rise from pre-booster levels in serogroup specific IgG concentration one month after booster vaccination for the serogroup W-135||||0.75
72370579|NCT00488683|144251633|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|-0.04||||0.84||95.0|||||Parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Pearson correlation coefficient between memory B cells one month after primary vaccination and rise from pre-booster levels in serogroup specific IgG concentration one month after booster vaccination for the serogroup W-135||||0.84
72460700|NCT01183013|144444243|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.696||||0.0002||95.0|1.594|4.559|||Regression, Logistic|A logistic regression model with terms for treatment, continuous HbA1c baseline, prior use of antidiabetic agents and country.||Treatment comparisons are for fixed dose combination versus monotherapy.||4.559|1.594|0.0002
72460701|NCT01183013|144444243|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.017|||<|0.0001||95.0|2.348|6.873|||Regression, Logistic|A logistic regression model with terms for treatment, continuous HbA1c baseline, prior use of antidiabetic agents and country.||Treatment comparisons are for fixed dose combination versus monotherapy.||6.873|2.348|<0.0001
72460702|NCT01183013|144444243|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|8.521|||<|0.0001||95.0|4.63|15.681|||Regression, Logistic|A logistic regression model with terms for treatment, continuous HbA1c baseline, prior use of antidiabetic agents and country.||Treatment comparisons are for fixed dose combination versus monotherapy.||15.681|4.630|<0.0001
72460703|NCT01183013|144444245|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.68||||0.4275|TWO_SIDED|95.0|-12.77|5.42|||ANCOVA|The model includes fixed effects for treatment, continuous baseline HbA1c, continuous baseline FPG, prior anti-diabetic medication and country.||Treatment comparisons are for fixed dose combination versus monotherapy.||5.42|-12.77|0.4275
72460704|NCT01183013|144444245|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.84||||0.6839|TWO_SIDED|95.0|-10.69|7.02|||ANCOVA|The model includes fixed effects for treatment, continuous baseline HbA1c, continuous baseline FPG, prior anti-diabetic medication and country.||Treatment comparisons are for fixed dose combination versus monotherapy.||7.02|-10.69|0.6839
72460705|NCT01183013|144444245|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.5||||0.1466|TWO_SIDED|95.0|-15.29|2.28|||ANCOVA|The model includes fixed effects for treatment, continuous baseline HbA1c, continuous baseline FPG, prior anti-diabetic medication and country.||Treatment comparisons are for fixed dose combination versus monotherapy.||2.28|-15.29|0.1466
72460706|NCT01183013|144444245|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.38||||0.0002|TWO_SIDED|95.0|-26.35|-8.41|||ANCOVA|The model includes fixed effects for treatment, continuous baseline HbA1c, continuous baseline FPG, prior anti-diabetic medication and country.||Treatment comparisons are for fixed dose combination versus monotherapy.||-8.41|-26.35|0.0002
72460707|NCT01183013|144444245|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-25.87|||<|0.0001|TWO_SIDED|95.0|-34.77|-16.98|||ANCOVA|The model includes fixed effects for treatment, continuous baseline HbA1c, continuous baseline FPG, prior anti-diabetic medication and country.||Treatment comparisons are for fixed dose combination versus monotherapy.||-16.98|-34.77|<0.0001
72460708|NCT01183013|144444245|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-33.73|||<|0.0001|TWO_SIDED|95.0|-42.57|-24.89|||ANCOVA|The model includes fixed effects for treatment, continuous baseline HbA1c, continuous baseline FPG, prior anti-diabetic medication and country.||Treatment comparisons are for fixed dose combination versus monotherapy.||-24.89|-42.57|<0.0001
72501347|NCT00775021|144532379|NON_INFERIORITY_OR_EQUIVALENCE|Margin = -0.5|Mean Difference (Final Values)|0.2334|STANDARD_ERROR_OF_MEAN|0.1618|||TWO_SIDED|95.0|-0.03501|0.2334|||Mixed Models Analysis||The mean difference is calculated as etafilconA minus nelfilcon A. Analysis is adjusted for lens type, period, lens type by period interaction, gender, lens type by gender interaction as fixed effects, subject nested within site as random effect.|The alternative hypothesis is that etafilcon A contact lenses will have equal to ro higher ratings of overall comfort than nelfilcon A contact lenses.||0.2334|-0.03501|
72501348|NCT00775021|144532380|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.108|STANDARD_ERROR_OF_MEAN|0.07768|||TWO_SIDED|98.7|-0.108|0.06501|||Mixed Models Analysis||Mean difference calculated etafilcon A minus nelfilcon A. Analysis adjusted for lens type, period, lens by period interaction, gender, lens by gender interaction as fixed effects, subject nested within site and eye within subject as random effect.|The alternative hypothesis is that eyes that wore etafilcon A contact lenses will have less inferior region corneal staining than eyes that wore nelfilcon A contact lenses.||0.06501|-0.1080|
72501349|NCT00775021|144532381|NON_INFERIORITY_OR_EQUIVALENCE|Margin = -0.5|Mean Difference (Final Values)|0.4001|STANDARD_ERROR_OF_MEAN|0.1799|||TWO_SIDED|98.7|-0.0055|0.4001|||Mixed Models Analysis||The mean difference is calculated as etafilcon A minus nelfilcon A.|The alternative hypothesis is that etafilcon A contact lenses have equal to or higher comfort ratings at the end of the day than nelfilcon A.||0.4001|-0.0055|
72501350|NCT00775021|144532382|NON_INFERIORITY_OR_EQUIVALENCE|Margin = -0.5|Mean Difference (Final Values)|-0.1088|STANDARD_ERROR_OF_MEAN|0.1741|||TWO_SIDED|98.7|-0.5016|-0.1088|||Mixed Models Analysis||The mean difference is calculated as etafilcon A minus nelfilcon A.|The alternative hypothesis is that etafilcon A contact lenses will have equal or higher ratings of initial comfort than nelfilcon A contact lenses.||-0.1088|-0.5016|
72501351|NCT00775021|144532383|NON_INFERIORITY_OR_EQUIVALENCE|Margin = -0.5|Mean Difference (Final Values)|0.2489|STANDARD_ERROR_OF_MEAN|0.168|||TWO_SIDED|98.7|-0.1301|0.2489|||Mixed Models Analysis||The mean difference is calculated as etafilcon A minus nelfilcon A.|The alternative hypothesis is that etaflicon A contact lenses have equal to or higher ratings of ease of handling than nelfilcon A contact lenses.||0.2489|-0.1301|
72563434|NCT00442546|144658177|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|7.298|STANDARD_ERROR_OF_MEAN|6.418||0.2615||95.0|-5.628|20.224|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2||20.224|-5.628|0.2615
72563435|NCT00442546|144658177|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.286|STANDARD_ERROR_OF_MEAN|6.707||0.6266||95.0|-10.22|16.795|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2||16.795|-10.22|0.6266
72563436|NCT00442546|144658177|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.17|STANDARD_ERROR_OF_MEAN|3.958||0.2963||95.0|-3.747|12.086|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4||12.086|-3.747|0.2963
72563437|NCT00442546|144658177|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|6.248|STANDARD_ERROR_OF_MEAN|4.151||0.1375||95.0|-2.054|14.55|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4||14.550|-2.054|0.1375
72563438|NCT00442546|144658177|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.431|STANDARD_ERROR_OF_MEAN|4.895||0.2703||95.0|-4.298|15.161|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET||15.161|-4.298|0.2703
72563439|NCT00442546|144658177|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|7.663|STANDARD_ERROR_OF_MEAN|4.664||0.104||95.0|-1.607|16.933|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET||16.933|-1.607|0.1040
72460709|NCT01183013|144444247|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-36.61||||0.0057|TWO_SIDED|95.0|-62.42|-10.8|||ANCOVA|The model includes fixed effects for treatment, continuous baseline HbA1c and 2-hour PPG, prior anti-diabetic medication and country.||Treatment comparisons are for fixed dose combination versus monotherapy.||-10.80|-62.42|0.0057
72460710|NCT01183013|144444247|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.94||||0.7021||95.0|-30.39|20.51|||ANCOVA|The model includes fixed effects for treatment, continuous baseline HbA1c and 2-hour PPG, prior anti-diabetic medication and country.||Treatment comparisons are for fixed dose combination versus monotherapy.||20.51|-30.39|0.7021
72460711|NCT01183013|144444247|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.78||||0.8932|TWO_SIDED|95.0|-27.95|24.38|||ANCOVA|The model includes fixed effects for treatment, continuous baseline HbA1c and 2-hour PPG, prior anti-diabetic medication and country.||Treatment comparisons are for fixed dose combination versus monotherapy.||24.38|-27.95|0.8932
72460712|NCT01183013|144444247|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.65||||0.2706|TWO_SIDED|95.0|-43.6|12.3|||ANCOVA|The model includes fixed effects for treatment, continuous baseline HbA1c and 2-hour PPG, prior anti-diabetic medication and country.||Treatment comparisons are for fixed dose combination versus monotherapy.||12.30|-43.60|0.2706
72460713|NCT01183013|144444247|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-36.33||||0.0126|TWO_SIDED|95.0|-64.78|-7.89|||ANCOVA|The model includes fixed effects for treatment, continuous baseline HbA1c and 2-hour PPG, prior anti-diabetic medication and country.||Treatment comparisons are for fixed dose combination versus monotherapy.||-7.89|-64.78|0.0126
72460714|NCT01183013|144444247|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-33.16||||0.0167|TWO_SIDED|95.0|-60.23|-6.08|||ANCOVA|The model includes fixed effects for treatment, continuous baseline HbA1c and 2-hour PPG, prior anti-diabetic medication and country.||Treatment comparisons are for fixed dose combination versus monotherapy.||-6.08|-60.23|0.0167
72460715|NCT01183013|144444249|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.649||||0.3052||95.0|0.284|1.482|||Regression, Logistic|A logistic regression model with terms for treatment, continuous HbA1c baseline, prior use of antidiabetic agents and country.||Treatment comparisons are for fixed dose combination versus monotherapy.||1.482|0.284|0.3052
72460716|NCT01183013|144444249|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.456||||0.0844|TWO_SIDED|95.0|0.187|1.112|||Regression, Logistic|A logistic regression model with terms for treatment, continuous HbA1c baseline, prior use of antidiabetic agents and country.||Treatment comparisons are for fixed dose combination versus monotherapy.||1.112|0.187|0.0844
72460717|NCT01183013|144444249|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.443||||0.1561|TWO_SIDED|95.0|0.143|1.365|||Regression, Logistic|A logistic regression model with terms for treatment, continuous HbA1c baseline, prior use of antidiabetic agents and country.||Treatment comparisons are for fixed dose combination versus monotherapy.||1.365|0.143|0.1561
72460718|NCT01183013|144444249|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.368||||0.0146||95.0|0.165|0.821|||Regression, Logistic|A logistic regression model with terms for treatment, continuous HbA1c baseline, prior use of antidiabetic agents and country.||Treatment comparisons are for fixed dose combination versus monotherapy.||0.821|0.165|0.0146
72460719|NCT01183013|144444249|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.238||||0.0009||95.0|0.102|0.557|||Regression, Logistic|A logistic regression model with terms for treatment, continuous HbA1c baseline, prior use of antidiabetic agents and country.||Treatment comparisons are for fixed dose combination versus monotherapy.||0.557|0.102|0.0009
72460720|NCT01183013|144444249|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.141||||0.0002||95.0|0.05|0.397|||Regression, Logistic|A logistic regression model with terms for treatment, continuous HbA1c baseline, prior use of antidiabetic agents and country.||Treatment comparisons are for fixed dose combination versus monotherapy.||0.397|0.050|0.0002
72460721|NCT03897075|144444250|SUPERIORITY|||||||0.00311|||||||Cochran-Mantel-Haenszel|||||||0.00311
72460722|NCT03897075|144444251|SUPERIORITY|||||||0.00079|||||||Cochran-Mantel-Haenszel|||||||0.00079
72460723|NCT03897075|144444252|SUPERIORITY|||||||0.09892|||||||Cochran-Mantel-Haenszel|||||||0.09892
72563440|NCT00442546|144658178|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.579|STANDARD_ERROR_OF_MEAN|3.154||0.8545||95.0|-5.635|6.793|||ANOVA||Mean difference (final values) = Least squares mean difference|Discharge||6.793|-5.635|0.8545
72460724|NCT00472199|144444263|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.6|STANDARD_ERROR_OF_MEAN|1.0||0.0077||95.0|-4.6|-0.7|||ANCOVA|||Analysis of covariance for changes from baseline with factors treatment and country and using baseline as covariate||-0.7|-4.6|0.0077
72460725|NCT00472199|144444264|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||Cochran-Mantel-Haenszel|||||||0.0010
72460726|NCT00472199|144444265|SUPERIORITY_OR_OTHER|||||||0.0044||95.0|||||Cochran-Mantel-Haenszel|||||||0.0044
72460727|NCT00472199|144444266|SUPERIORITY_OR_OTHER|||||||0.0011||95.0|||||Cochran-Mantel-Haenszel|||||||0.0011
72460728|NCT00472199|144444267|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-1.0||||0.0489||95.0|-1.1|-0.9|||Wilcoxon (Mann-Whitney)|||||-0.9|-1.1|0.0489
72460729|NCT00472199|144444268|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.0315|TWO_SIDED|95.0|0.0|0.0|||Wilcoxon (Mann-Whitney)|||||0.0|-0.0|0.0315
72460730|NCT00472199|144444269|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.0735|TWO_SIDED|95.0|0.0|0.0|||Wilcoxon (Mann-Whitney)|||||0.0|-0.0|0.0735
72460731|NCT00472199|144444270|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.841|TWO_SIDED|95.0|0.0|0.0|||Wilcoxon (Mann-Whitney)|||||0.0|-0.0|0.8410
72460732|NCT00472199|144444271|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.9241|TWO_SIDED|95.0|0.0|0.0|||Wilcoxon (Mann-Whitney)|||||0.0|-0.0|0.9241
72460733|NCT00472199|144444272|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.8093|TWO_SIDED|95.0|0.0|0.0|||Wilcoxon (Mann-Whitney)|||||0.0|-0.0|0.8093
72563441|NCT00442546|144658178|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.128|STANDARD_ERROR_OF_MEAN|3.155||0.5006||95.0|-4.088|8.344|||ANOVA||Mean difference (final values) = Least squares mean difference|Discharge||8.344|-4.088|0.5006
72563442|NCT00442546|144658178|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.956|STANDARD_ERROR_OF_MEAN|8.248||0.7217||95.0|-13.66|19.569|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2||19.569|-13.66|0.7217
72563443|NCT00442546|144658178|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|7.011|STANDARD_ERROR_OF_MEAN|8.62||0.4203||95.0|-10.35|24.372|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2||24.372|-10.35|0.4203
72392677|NCT01218204|144292589|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-13.18|||||TWO_SIDED|95.0|-23.0636|-3.2961|||||Statistical analysis was performed using LS mean value of GSK1292263|For Non-HDLc||-3.2961|-23.0636|
72392678|NCT01218204|144292589|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-22.151|||||TWO_SIDED|95.0|-31.942|-12.3605|||||Statistical analysis was performed using LS mean value of GSK1292263|For Non-HDLc||-12.3605|-31.9420|
72392679|NCT01218204|144292589|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-26.948|||||TWO_SIDED|95.0|-36.2874|-17.6092|||||Statistical analysis was performed using LS mean value of GSK1292263|For Non-HDLc||-17.6092|-36.2874|
72392680|NCT01218204|144292589|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.904|||||TWO_SIDED|95.0|-11.8484|4.04|||||Statistical analysis was performed using LS mean value of Atorvastatin|For Cholesterol||4.0400|-11.8484|
72392681|NCT01218204|144292589|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-6.437|||||TWO_SIDED|95.0|-14.346|1.4722|||||Statistical analysis was performed using LS mean value of Atorvastatin|For Cholesterol||1.4722|-14.3460|
72460734|NCT00472199|144444273|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.0583|TWO_SIDED|95.0|0.0|0.0|||Wilcoxon (Mann-Whitney)|||||0.0|-0.0|0.0583
72460735|NCT00472199|144444274|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-5.0||||0.0916|TWO_SIDED|95.0|-5.5|-4.5|||Wilcoxon (Mann-Whitney)|||||-4.5|-5.5|0.0916
72460736|NCT00472199|144444275|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|2.5||||0.5905|TWO_SIDED|95.0|2.2|2.8|||Wilcoxon (Mann-Whitney)|||||2.8|2.2|0.5905
72501352|NCT03464045|144532387|OTHER||Hazard Ratio (HR)|0.8||||0.122|TWO_SIDED|95.0|0.61|1.06|||Regression, Cox||Crude hazard ratio of empagliflozin/DPP-4i|Crude HRs were calculated using a Cox proportional hazards model with as-treated exposure (continuous exposure to the study drugs, defined as having consecutive treatment episodes separated by a grace period of 30 days, starting from index date) as the only included variable. Country-level HRs were analyzed separately. Thereafter, random-effects meta-analyses were conducted to pool the HRs from all countries, accounting for potential heterogeneity between the country-level effect sizes.||1.06|0.61|0.122
72563444|NCT00442546|144658178|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|5.6||0.9859||95.0|-11.3|11.102|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4||11.102|-11.30|0.9859
72563445|NCT00442546|144658178|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.063|STANDARD_ERROR_OF_MEAN|5.873||0.9915||95.0|-11.68|11.811|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4||11.811|-11.68|0.9915
72392682|NCT01218204|144292589|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-10.294|||||TWO_SIDED|95.0|-18.3923|-2.196|||||Statistical analysis was performed using LS mean value of Atorvastatin|For Cholesterol||-2.1960|-18.3923|
72392683|NCT01218204|144292589|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-12.065|||||TWO_SIDED|95.0|-19.7688|-4.3609|||||Statistical analysis was performed using LS mean value of Atorvastatin|For Cholesterol||-4.3609|-19.7688|
72460737|NCT00472199|144444276|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|2.0||||0.0179|TWO_SIDED|95.0|1.6|2.4|||Wilcoxon (Mann-Whitney)|||||2.4|1.6|0.0179
72460738|NCT00472199|144444277|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|2.0||||0.545|TWO_SIDED|95.0|1.7|2.3|||Wilcoxon (Mann-Whitney)|||||2.3|1.7|0.5450
72392684|NCT01218204|144292589|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-7.941|||||TWO_SIDED|95.0|-13.9778|-1.9039|||||Statistical analysis was performed using LS mean value of Atorvastatin|For Cholesterol||-1.9039|-13.9778|
72392685|NCT01218204|144292589|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-8.384|||||TWO_SIDED|95.0|-15.9023|-0.866|||||Statistical analysis was performed using LS mean value of GSK1292263|For Cholesterol||-0.8660|-15.9023|
72392686|NCT01218204|144292589|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-15.7|||||TWO_SIDED|95.0|-23.1404|-8.2592|||||Statistical analysis was performed using LS mean value of GSK1292263|For Cholesterol||-8.2592|-23.1404|
72392687|NCT01218204|144292589|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-16.728|||||TWO_SIDED|95.0|-23.8395|-9.6161||||||For Cholesterol||-9.6161|-23.8395|
72392688|NCT01218204|144292590|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-12.123|||||TWO_SIDED|95.0|-26.6276|2.3814|||||Statistical analysis was performed using LS mean value of Atorvastatin|||2.3814|-26.6276|
72392689|NCT01218204|144292590|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-21.63|||||TWO_SIDED|95.0|-35.9419|-7.3181|||||Statistical analysis was performed using LS mean value of Atorvastatin|||-7.3181|-35.9419|
72392690|NCT01218204|144292590|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-41.506|||||TWO_SIDED|95.0|-56.3924|-26.6205|||||Statistical analysis was performed using LS mean value of Atorvastatin|||-26.6205|-56.3924|
72392691|NCT01218204|144292590|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-28.041|||||TWO_SIDED|95.0|-42.2554|-13.8263|||||Statistical analysis was performed using LS mean value of Atorvastatin|||-13.8263|-42.2554|
72392692|NCT01218204|144292590|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-29.293|||||TWO_SIDED|95.0|-51.5654|-12.4042|||||Statistical analysis was performed using LS mean value of Atorvastatin|||-12.4042|-51.5654|
72392693|NCT01218204|144292590|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-20.042|||||TWO_SIDED|95.0|-34.8358|-5.2472|||||Statistical analysis was performed using LS mean value of GSK1292263|||-5.2472|-34.8358|
72392694|NCT01218204|144292590|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-21.903|||||TWO_SIDED|95.0|-36.6155|-7.1913|||||Statistical analysis was performed using LS mean value of GSK1292263|||-7.1913|-36.6155|
72392695|NCT01218204|144292590|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-35.735|||||TWO_SIDED|95.0|-49.722|-21.7485|||||Statistical analysis was performed using LS mean value of GSK1292263|||-21.7485|-49.7220|
72392696|NCT01218204|144292591|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.409|||||TWO_SIDED|95.0|-1.0123|0.1942|||||Statistical analysis was performed using LS mean value of Atorvastatin|||0.1942|-1.0123|
72460739|NCT00472199|144444278|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.1456|TWO_SIDED|95.0|-0.3|0.3|||Wilcoxon (Mann-Whitney)|||||0.3|-0.3|0.1456
72460740|NCT00472199|144444279|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.2915|TWO_SIDED|95.0|-0.4|0.4|||Wilcoxon (Mann-Whitney)|||||0.4|-0.4|0.2915
72460741|NCT00472199|144444280|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.3131|TWO_SIDED|95.0|-0.4|0.4|||Wilcoxon (Mann-Whitney)|||||0.4|-0.4|0.3131
72460742|NCT00472199|144444281|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.5713|TWO_SIDED|95.0|-0.4|0.4|||Wilcoxon (Mann-Whitney)|||||0.4|-0.4|0.5713
72460743|NCT00472199|144444282|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.8432|TWO_SIDED|95.0|-0.4|0.4|||Wilcoxon (Mann-Whitney)|||||0.4|-0.4|0.8432
72460744|NCT00472199|144444283|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|6.3||||0.0206|TWO_SIDED|95.0|5.9|6.6|||Wilcoxon (Mann-Whitney)|||||6.6|5.9|0.0206
72460745|NCT00472199|144444284|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.6||||0.5602|TWO_SIDED|95.0|0.4|0.8|||Wilcoxon (Mann-Whitney)|||||0.8|0.4|0.5602
72460746|NCT00472199|144444285|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|1.0||||0.136|TWO_SIDED|95.0|0.8|1.1|||Wilcoxon (Mann-Whitney)|||||1.1|0.8|0.1360
72460747|NCT00472199|144444287|SUPERIORITY_OR_OTHER|||||||0.0022||95.0|||||Mantel Haenszel|||||||0.0022
72460748|NCT02446912|144444299|SUPERIORITY|The difference in estimates and associated 95% CI are weighted and are calculated using a stratified Cochran-Mantel-Haenszel (CMH) approach, with stratification factors (SLEDAI-2K score at screening \[\<10 points vs \>= 10 points\], Week 0 OCS dose \[\<10 mg/day vs \>=10 mg/day prednisone or equivalent\] and type I IFN gene signature test result at screening \[high vs low\]).|Mean Difference (Final Values)|-4.2||||0.412|TWO_SIDED|95.0|-14.2|5.8||Nominal p-value|Cochran-Mantel-Haenszel|||||5.8|-14.2|0.412
72460749|NCT02446912|144444299|SUPERIORITY||Mean Difference (Final Values)|-2.6|||||TWO_SIDED|95.0|-14.7|9.6||||||||9.6|-14.7|
72460750|NCT02446912|144444300|SUPERIORITY|The difference in estimates and associated 95% CI are weighted and are calculated using a stratified Cochran-Mantel-Haenszel (CMH) approach, with stratification factors (SLEDAI-2K score at screening \[\<10 points vs \>= 10 points\], Week 0 OCS dose \[\<10 mg/day vs \>=10 mg/day prednisone or equivalent\] and type I IFN gene signature test result at screening \[high vs low\]).|Mean Difference (Final Values)|3.9||||0.455|TWO_SIDED|95.0|-6.3|14.1||Nominal p-value|Cochran-Mantel-Haenszel|||||14.1|-6.3|0.455
72460751|NCT02446912|144444300|SUPERIORITY||Mean Difference (Final Values)|5.5|||||TWO_SIDED|95.0|-6.7|17.8||||||||17.8|-6.7|
72460752|NCT02446912|144444301|SUPERIORITY|The difference in estimates and associated 95% CI are weighted and are calculated using a stratified Cochran-Mantel-Haenszel (CMH) approach, with stratification factors (SLEDAI-2K score at screening \[\<10 points vs \>= 10 points\], Week 0 OCS dose \[\<10 mg/day vs \>=10 mg/day prednisone or equivalent\] and type I IFN gene signature test result at screening \[high vs low\]).|Mean Difference (Final Values)|-3.4||||0.549|TWO_SIDED|95.0|-14.4|7.6||Nominal p-value|Cochran-Mantel-Haenszel|||||7.6|-14.4|0.549
72501353|NCT03464045|144532387|OTHER||Hazard Ratio (HR)|0.89||||0.417|TWO_SIDED|95.0|0.67|1.18|||Regression, Cox||Base hazard ratio of empagliflozin/DPP-4i|"Base HRs were calculated using a Cox proportional hazards model by adjusting for variables unbalanced after PS matching. To be included in the Cox model, each covariate is required to have a minimum of 5 events per category level to avoid converge failure.~Country-level HRs were analyzed separately. Thereafter, random-effects meta-analyses were conducted to pool the HRs from all countries, accounting for potential heterogeneity between the country-level effect sizes."||1.18|0.67|0.417
72501354|NCT03464045|144532387|OTHER||Hazard Ratio (HR)|0.88||||0.376|TWO_SIDED|95.0|0.66|1.17|||Regression, Cox||Adjusted hazard ratio of empagliflozin/DPP-4i|Adjusted HRs were calculated using a Cox proportional hazards model by adjusting for variables unbalanced after PS matching, and pre-specified time-varying covariates. To be included in the Cox model, each covariate is required to have a minimum of 5 events per category level. Country-level HRs were analyzed separately. Thereafter, random-effects meta-analyses were conducted to pool the HRs from all countries, accounting for potential heterogeneity between the country-level effect sizes.||1.17|0.66|0.376
72501355|NCT03464045|144532388|OTHER||Hazard Ratio (HR)|0.79||||0.22|TWO_SIDED|95.0|0.55|1.15|||Regression, Cox||Crude hazard ratio of empagliflozin/DPP-4i|Crude HRs were calculated using a Cox proportional hazards model with as-treated exposure (continuous exposure to the study drugs, defined as having consecutive treatment episodes separated by a grace period of 30 days, starting from index date) as the only included variable. Country-level HRs were analyzed separately. Thereafter, random-effects meta-analyses were conducted to pool the HRs from all countries, accounting for potential heterogeneity between the country-level effect sizes.||1.15|0.55|0.220
72563446|NCT00442546|144658178|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.128|STANDARD_ERROR_OF_MEAN|6.508||0.9843||95.0|-13.06|12.808|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET||12.808|-13.06|0.9843
72460753|NCT02446912|144444302|SUPERIORITY|The difference in estimates and associated 95% CI are weighted and are calculated using a stratified Cochran-Mantel-Haenszel (CMH) approach, with stratification factors (SLEDAI-2K score at screening \[\<10 points vs \>= 10 points\], Week 0 OCS dose \[\<10 mg/day vs \>=10 mg/day prednisone or equivalent\] and type I IFN gene signature test result at screening \[high vs low\]).|Mean Difference (Final Values)|6.4||||0.261|TWO_SIDED|95.0|-4.8|17.7||Nominal p-value|Cochran-Mantel-Haenszel|||||17.7|-4.8|0.261
72460754|NCT02446912|144444303|SUPERIORITY|The difference in estimates and associated 95% CI are weighted and are calculated using a stratified Cochran-Mantel-Haenszel (CMH) approach, with stratification factors (SLEDAI-2K score at screening \[\<10 points vs \>= 10 points\], Week 0 OCS dose \[\<10 mg/day vs \>=10 mg/day prednisone or equivalent\] and type I IFN gene signature test result at screening \[high vs low\]).|Mean Difference (Final Values)|8.9||||0.18|TWO_SIDED|95.0|-4.1|21.9||Nominal p-value|Cochran-Mantel-Haenszel|||||21.9|-4.1|0.180
72460755|NCT02446912|144444304|SUPERIORITY|The difference in estimates and associated 95% CI are weighted and are calculated using a stratified Cochran-Mantel-Haenszel (CMH) approach, with stratification factors (SLEDAI-2K score at screening \[\<10 points vs \>= 10 points\], Week 0 OCS dose \[\<10 mg/day vs \>=10 mg/day prednisone or equivalent\] and type I IFN gene signature test result at screening \[high vs low\]).|Mean Difference (Final Values)|16.7||||0.013|TWO_SIDED|95.0|3.5|29.8||Nominal p-value|Cochran-Mantel-Haenszel|||||29.8|3.5|0.013
72460756|NCT02446912|144444305|SUPERIORITY|The difference in estimates and associated 95% CI are weighted and are calculated using a stratified Cochran-Mantel-Haenszel (CMH) approach, with stratification factors (SLEDAI-2K score at screening \[\<10 points vs \>= 10 points\], Week 0 OCS dose \[\<10 mg/day vs \>=10 mg/day prednisone or equivalent\] and type I IFN gene signature test result at screening \[high vs low\]).|Mean Difference (Final Values)|17.0||||0.054|TWO_SIDED|95.0|-0.3|34.3||Nominal p-value|Cochran-Mantel-Haenszel|||||34.3|-0.3|0.054
72460757|NCT02446912|144444306|SUPERIORITY|The difference in estimates and associated 95% CI are weighted and are calculated using a stratified Cochran-Mantel-Haenszel (CMH) approach, with stratification factors (SLEDAI-2K score at screening \[\<10 points vs \>= 10 points\], Week 0 OCS dose \[\<10 mg/day vs \>=10 mg/day prednisone or equivalent\] and type I IFN gene signature test result at screening \[high vs low\]).|Mean Difference (Final Values)|18.7||||0.034|TWO_SIDED|95.0|1.4|36.0||Nominal p-value|Cochran-Mantel-Haenszel|||||36.0|1.4|0.034
72460758|NCT02446912|144444307|SUPERIORITY|The difference in estimates and associated 95% CI are weighted and are calculated using a stratified Cochran-Mantel-Haenszel (CMH) approach, with stratification factors (SLEDAI-2K score at screening \[\<10 points vs \>= 10 points\], Week 0 OCS dose \[\<10 mg/day vs \>=10 mg/day prednisone or equivalent\] and type I IFN gene signature test result at screening \[high vs low\]).|Mean Difference (Final Values)|0.6||||0.905|TWO_SIDED|95.0|-9.4|10.6||Nominal p-value|Cochran-Mantel-Haenszel|||||10.6|-9.4|0.905
72460759|NCT02446912|144444308|SUPERIORITY|The difference in estimates and associated 95% CI are weighted and are calculated using a stratified Cochran-Mantel-Haenszel (CMH) approach, with stratification factors (SLEDAI-2K score at screening \[\<10 points vs \>= 10 points\], Week 0 OCS dose \[\<10 mg/day vs \>=10 mg/day prednisone or equivalent\] and type I IFN gene signature test result at screening \[high vs low\]).|Mean Difference (Final Values)|3.3||||0.515|TWO_SIDED|95.0|-6.7|13.4||Nominal p-value|Cochran-Mantel-Haenszel|||||13.4|-6.7|0.515
72460760|NCT02446912|144444309|SUPERIORITY|Analysed using a negative binomial regression model. The response variable in the model is the number of flares over the 52-week treatment period. The model includes covariates of treatment group, and the stratification factors (SLEDAI-2K score at screening \[\<10 points vs \>=10 points\], Week 0 OCS dose \[\<10 mg/day vs \>=10 mg/day prednisone or equivalent\] and type I IFN gene signature test result at screening \[high vs low\]). The logarithm of the follow-up time is used as an offset variable.|Rate Ratio|0.83||||0.258|TWO_SIDED|95.0|0.6|1.14||Nominal p-value|Negative binomial regression|||||1.14|0.60|0.258
72460761|NCT02446912|144444310|SUPERIORITY|The difference in estimates and associated 95% CI are weighted and are calculated using a stratified Cochran-Mantel-Haenszel (CMH) approach, with stratification factors (SLEDAI-2K score at screening \[\<10 points vs \>= 10 points\], Week 0 OCS dose \[\<10 mg/day vs \>=10 mg/day prednisone or equivalent\] and type I IFN gene signature test result at screening \[high vs low\]).|Mean Difference (Final Values)|10.1|||||TWO_SIDED|95.0|0.6|19.7|||Cochran-Mantel-Haenszel|||||19.7|0.6|
72460762|NCT02446912|144444311|SUPERIORITY|The difference in estimates and associated 95% CI are weighted and are calculated using a stratified Cochran-Mantel-Haenszel (CMH) approach, with stratification factors (SLEDAI-2K score at screening \[\<10 points vs \>= 10 points\], Week 0 OCS dose \[\<10 mg/day vs \>=10 mg/day prednisone or equivalent\] and type I IFN gene signature test result at screening \[high vs low\]).|Mean Difference (Final Values)|16.4|||||TWO_SIDED|95.0|6.7|26.2|||Cochran-Mantel-Haenszel|||||26.2|6.7|
72460763|NCT01014013|144444331|NON_INFERIORITY_OR_EQUIVALENCE|The primary efficacy endpoint was based on the proportion of patients who had a favorable microbiological response assessment at follow-up 5 to 9 days post-therapy visit. The definition of non-inferiority is that the 95%(two-sided) confidence interval for the difference in response rate between the 2 treatment groups(MK0826 minus control group) contains zero and the lower limit of the CI is not less than -20 percentage points.|the difference between two response rate|-0.8|STANDARD_DEVIATION|10.9||||95.0|-11.7|10.2||||||||10.2|-11.7|
72460764|NCT01014013|144444333|NON_INFERIORITY_OR_EQUIVALENCE|The secondary efficacy endpoint was based on the proportion of patients who had a favorable clinical response assessment at follow-up 5 to 9 days post-therapy visit. The definition of non-inferiority is that the 95%(two-sided) confidence interval for the difference in response rate between the 2 treatment groups(MK0826 minus control group) contains zero and the lower limit of the CI is not less than -20 percentage points.|the difference between two response rate|-1.7|STANDARD_ERROR_OF_MEAN|4.9||||95.0|-6.6|3.2||||||||3.2|-6.6|
72460765|NCT02100189|144444350|SUPERIORITY_OR_OTHER||Sensitivity|13.3|STANDARD_ERROR_OF_MEAN|0.062|||TWO_SIDED|95.0|3.76|30.72|||Sensitivity||Exact Binomial confidence interval.|||30.72|3.76|
72460766|NCT02100189|144444351|SUPERIORITY_OR_OTHER||Specificity|94.7|STANDARD_ERROR_OF_MEAN|0.051|||TWO_SIDED|95.0|73.97|99.87|||Specificity||Exact binomial confidence interval|||99.87|73.97|
72563447|NCT00442546|144658178|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.351|STANDARD_ERROR_OF_MEAN|6.201||0.7055||95.0|-9.974|14.677|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET||14.677|-9.974|0.7055
72460767|NCT02213458|144444360|SUPERIORITY||Slope|0.539||||0.04|TWO_SIDED|95.0|0.259|1.337|||Mixed Models Analysis|Controlling for dementia severity (QDRS)||Linear mixed effects model||1.337|.259|0.04
72563448|NCT00442546|144658179|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.024|STANDARD_ERROR_OF_MEAN|0.315||0.9405||95.0|-0.614|0.661|||ANOVA||Mean difference (final values) = Least squares mean difference|Discharge||0.661|-0.614|0.9405
72563449|NCT00442546|144658179|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.167|STANDARD_ERROR_OF_MEAN|0.287||0.5641||95.0|-0.749|0.415|||ANOVA||Mean difference (final values) = Least squares mean difference|Discharge||0.415|-0.749|0.5641
72460768|NCT02213458|144444361|SUPERIORITY||Slope|-0.138||||0.05|TWO_SIDED|95.0|-0.295|-0.02|||Mixed Models Analysis|Linear mixed model controlling for dementia severity (QDRS)||||-.020|-.295|.05
72563450|NCT00442546|144658179|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.5|STANDARD_ERROR_OF_MEAN|0.755||0.5226||95.0|-1.181|2.181|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2||2.181|-1.181|0.5226
72460769|NCT02213458|144444362|SUPERIORITY||Slope|-1.902||||0.07|TWO_SIDED|95.0|-3.885|-0.08|||Mixed Models Analysis|Linear mixed model controlling for dementia severity (QDRS)||||-0.080|-3.885|0.07
72460770|NCT02213458|144444364|SUPERIORITY||Slope|-1.143||||0.03|TWO_SIDED|95.0|-2.154|-0.132|||Mixed Models Analysis|||||-0.132|-2.154|0.03
72460771|NCT02213458|144444365|SUPERIORITY||Slope|0.635||||0.11|TWO_SIDED|95.0|-0.135|1.405|||Mixed Models Analysis|Controlling for dementia severity (QDRS)||||1.405|-0.135|0.11
72460772|NCT04799587|144444377|SUPERIORITY|Sample size for the study was determined by assuming a baseline rate of 33% of IONV and that there will be a relative decrease of 50% in the group that receives P6 acupressure during CD. A two-sided Fisher's Exact Test, with a significance level of 0.05, group sizes of 98 are needed to achieve 80% power to detect a difference between the group proportions of 0.18. Group sizes were rounded up to 100. Statistical analyses were two-sided, and a P\<0.05 was required to reject the null hypothesis.||||||0.94|||||||Chi-squared|||The incidence of nausea and vomiting and the number of episodes between the P6 acupressure and sham acupressure groups were compared using a chi-square statistic (nominal data) or the Wilcoxon test (continuous data).||||.94
72563451|NCT00442546|144658179|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.167|STANDARD_ERROR_OF_MEAN|0.893||0.8557||95.0|-2.156|1.823|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2||1.823|-2.156|0.8557
72563452|NCT00442546|144658179|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.328|STANDARD_ERROR_OF_MEAN|0.882||0.1925||95.0|-3.596|0.94|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4||0.940|-3.596|0.1925
72563453|NCT00442546|144658179|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.045|STANDARD_ERROR_OF_MEAN|0.982||0.9654||95.0|-2.568|2.479|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4||2.479|-2.568|0.9654
72460773|NCT04799587|144444378|SUPERIORITY|||||||0.95|||||||Chi-squared|||The sample size for the study was determined by assuming a baseline rate of 33% of intraoperative nausea and vomiting and that there will be a relative decrease of 50% in the group that receives P6 acupressure during CD.20 Using a two-sided Fisher's Exact Test, with a significance level of 0.05, group sizes of 98 are needed to achieve 80% power to detect a difference between the group proportions of 0.18. Group sizes were rounded up to 100||||.95
72460774|NCT00515281|144444400|SUPERIORITY|||||||0.017|||||||Chi-squared|||||||0.017
72460775|NCT00515281|144444401|SUPERIORITY|||||||0.288|||||||Chi-squared|||||||0.288
72460776|NCT00515281|144444402|SUPERIORITY|||||||0.009|||||||Chi-squared|||||||0.009
72460777|NCT00515281|144444403|SUPERIORITY|||||||0.97|||||||Chi-squared|||||||0.97
72563454|NCT00442546|144658179|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.352|STANDARD_ERROR_OF_MEAN|1.782||0.235||95.0|-6.712|2.008|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET||2.008|-6.712|0.2350
72563455|NCT00442546|144658179|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.296|STANDARD_ERROR_OF_MEAN|0.859||0.742||95.0|-1.806|2.399|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET||2.399|-1.806|0.7420
72563456|NCT00442546|144658180|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.208|STANDARD_ERROR_OF_MEAN|0.329||0.5299||95.0|-0.458|0.874|||ANOVA||Mean difference (final values) = Least squares mean difference|Discharge||0.874|-0.458|0.5299
72563457|NCT00442546|144658180|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.355|STANDARD_ERROR_OF_MEAN|0.3||0.2442||95.0|-0.964|0.253|||ANOVA||Mean difference (final values) = Least squares mean difference|Discharge||0.253|-0.964|0.2442
72563458|NCT00442546|144658180|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.5|STANDARD_ERROR_OF_MEAN|0.755||0.5226||95.0|-1.181|2.181|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2||2.181|-1.181|0.5226
72563459|NCT00442546|144658180|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.167|STANDARD_ERROR_OF_MEAN|0.893||0.8557||95.0|-2.156|1.823|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2||1.823|-2.156|0.8557
72460778|NCT00515281|144444404|SUPERIORITY|||||||0.72|||||||Chi-squared|||||||0.72
72460779|NCT00515281|144444405|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
72460780|NCT00515281|144444406|SUPERIORITY|||||||0.28|||||||Chi-squared|||||||0.28
72460781|NCT01292005|144444407|SUPERIORITY_OR_OTHER|||||||0.62||95.0|||||Wilcoxon (Mann-Whitney)|||Change from Day 0 to Day 1. p\<0.05 was considered statistically significant.||||0.62
72460782|NCT01292005|144444407|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Wilcoxon (Mann-Whitney)|||Change from Day 0 to Day 3. p\<0.05 was considered statistically significant.||||1.0
72460783|NCT01292005|144444408|SUPERIORITY_OR_OTHER|||||||0.72||95.0|||||Wilcoxon (Mann-Whitney)|||Change from Day 0 to Day 1. p\<0.05 was considered statistically significant.||||0.72
72460784|NCT01292005|144444408|SUPERIORITY_OR_OTHER|||||||0.5||95.0|||||Wilcoxon (Mann-Whitney)|||Change from Day 0 to Day 3. p\<0.05 was considered statistically significant.||||0.50
72460785|NCT01292005|144444409|SUPERIORITY_OR_OTHER|||||||0.58||95.0|||||Wilcoxon (Mann-Whitney)|||Change from Day 0 to Day 1. p\<0.05 was considered statistically significant.||||0.58
72460786|NCT01292005|144444409|SUPERIORITY_OR_OTHER|||||||0.8||95.0|||||Wilcoxon (Mann-Whitney)|||Change from Day 0 to Day 3. p\<0.05 was considered statistically significant.||||0.80
72460787|NCT01292005|144444410|SUPERIORITY_OR_OTHER|||||||0.9||95.0|||||Wilcoxon (Mann-Whitney)|||Change from Day 0 to Day 1. p\<0.05 was considered statistically significant.||||0.90
72460788|NCT01292005|144444410|SUPERIORITY_OR_OTHER|||||||0.56||95.0|||||Wilcoxon (Mann-Whitney)|||Change from Day 0 to Day 3. p\<0.05 was considered statistically significant.||||0.56
72460789|NCT01292005|144444411|SUPERIORITY_OR_OTHER|||||||0.09||95.0|||||Wilcoxon (Mann-Whitney)|||p\<0.05 was considered statistically significant.||||0.09
72460790|NCT01292005|144444412|SUPERIORITY_OR_OTHER|||||||0.22||95.0|||||Wilcoxon (Mann-Whitney)|||p\<0.05 was considered statistically significant.||||0.22
72460791|NCT01292005|144444413|SUPERIORITY_OR_OTHER|||||||0.04||95.0|||||t-test, 2 sided|||Comparison between arms for length of hospitalization \> 4 days. P \< 0.05 was considered statistically significant.||||0.04
72460792|NCT01292005|144444413|SUPERIORITY_OR_OTHER|||||||0.03||95.0|||||t-test, 2 sided|||Comparison was for length of hospitalization \>10 days. P \< 0.05 was considered statistically significant.||||0.03
72460793|NCT01292005|144444414|SUPERIORITY_OR_OTHER|||||||0.06||95.0|||||t-test, 2 sided|||P \< 0.05 was considered statistically significant.||||0.06
72460794|NCT01292005|144444415|SUPERIORITY_OR_OTHER|||||||0.03||95.0|||||Wilcoxon (Mann-Whitney)|||P \< 0.05 was considered statistically significant.||||0.03
72460795|NCT01292005|144444416|SUPERIORITY_OR_OTHER|||||||0.04||95.0|||||Wilcoxon (Mann-Whitney)|||P \< 0.05 was considered statistically significant.||||0.04
72460796|NCT00936065|144444424|SUPERIORITY_OR_OTHER|||||||0.0672|TWO_SIDED||||||Fisher Exact|||Overall treatment difference||||0.0672
72460797|NCT00936065|144444425|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Fisher Exact|||Overall treatment difference Week 2||||1.0000
72460798|NCT00936065|144444425|SUPERIORITY_OR_OTHER|||||||0.0229|TWO_SIDED||||||Fisher Exact|||Overall treatment difference Week 4||||0.0229
72460799|NCT00936065|144444425|SUPERIORITY_OR_OTHER|||||||0.0256|TWO_SIDED||||||Fisher Exact|||Overall treatment difference Week 8||||0.0256
72460800|NCT00936065|144444425|SUPERIORITY_OR_OTHER|||||||0.0004|TWO_SIDED||||||Fisher Exact|||Overall treatment difference Week 12||||0.0004
72460801|NCT00936065|144444425|SUPERIORITY_OR_OTHER|||||||0.0105|TWO_SIDED||||||Fisher Exact|||Overall treatment difference Week 18||||0.0105
72460802|NCT00936065|144444425|SUPERIORITY_OR_OTHER|||||||0.0366|TWO_SIDED||||||Fisher Exact|||Overall treatment difference Week 24||||0.0366
72460803|NCT00936065|144444426|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Fisher Exact|||Overall treatment difference at Week 8||||1.0000
72460804|NCT00936065|144444426|SUPERIORITY_OR_OTHER|||||||0.323|TWO_SIDED||||||Fisher Exact|||Overall treatment difference at Week 12||||0.3230
72460805|NCT00936065|144444426|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Fisher Exact|||Overall treatment difference at Week 18||||1.0000
72460806|NCT00936065|144444426|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Fisher Exact|||Overall treatment difference at Week 24||||1.0000
72460807|NCT00936065|144444427|SUPERIORITY_OR_OTHER|||||||0.3103|TWO_SIDED||||||Fisher Exact|||Overall treatment difference at Week 2||||0.3103
72460808|NCT00936065|144444427|SUPERIORITY_OR_OTHER|||||||0.4763|TWO_SIDED||||||Fisher Exact|||Overall treatment difference at Week 4||||0.4763
72501356|NCT03464045|144532388|OTHER||Hazard Ratio (HR)|0.91||||0.628|TWO_SIDED|95.0|0.63|1.32|||Regression, Cox||Base hazard ratio of empagliflozin/DPP-4i|"Base HRs were calculated using a Cox proportional hazards model by adjusting for variables unbalanced after PS matching. To be included in the Cox model, each covariate is required to have a minimum of 5 events per category level to avoid converge failure.~Country-level HRs were analyzed separately. Thereafter, random-effects meta-analyses were conducted to pool the HRs from all countries, accounting for potential heterogeneity between the country-level effect sizes."||1.32|0.63|0.628
72501357|NCT03464045|144532388|OTHER||Hazard Ratio (HR)|0.91||||0.632|TWO_SIDED|95.0|0.63|1.33|||Regression, Cox||Adjusted hazard ratio of empagliflozin/DPP-4i|Adjusted HRs were calculated using a Cox proportional hazards model by adjusting for variables unbalanced after PS matching, and pre-specified time-varying covariates. To be included in the Cox model, each covariate is required to have a minimum of 5 events per category level. Country-level HRs were analyzed separately. Thereafter, random-effects meta-analyses were conducted to pool the HRs from all countries, accounting for potential heterogeneity between the country-level effect sizes.||1.33|0.63|0.632
72501358|NCT03464045|144532389|OTHER||Hazard Ratio (HR)|0.84||||0.42|TWO_SIDED|95.0|0.54|1.29|||Regression, Cox||Crude hazard ratio of empagliflozin/DPP-4i|Crude HRs were calculated using a Cox proportional hazards model with as-treated exposure (continuous exposure to the study drugs, defined as having consecutive treatment episodes separated by a grace period of 30 days, starting from index date) as the only included variable. Country-level HRs were analyzed separately. Thereafter, random-effects meta-analyses were conducted to pool the HRs from all countries, accounting for potential heterogeneity between the country-level effect sizes.||1.29|0.54|0.420
72563460|NCT00442546|144658180|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.119|STANDARD_ERROR_OF_MEAN|1.024||0.324||95.0|-3.751|1.512|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4||1.512|-3.751|0.3240
72563461|NCT00442546|144658180|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.075|STANDARD_ERROR_OF_MEAN|1.139||0.9503||95.0|-2.853|3.003|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4||3.003|-2.853|0.9503
72563462|NCT00442546|144658180|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.833|STANDARD_ERROR_OF_MEAN|1.858||0.3618||95.0|-6.379|2.712|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET||2.712|-6.379|0.3618
72563463|NCT00442546|144658180|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.333|STANDARD_ERROR_OF_MEAN|0.896||0.7226||95.0|-1.859|2.525|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET||2.525|-1.859|0.7226
72563464|NCT00442546|144658181|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2473||95.0|||||Cochran-Mantel-Haenszel|||Discharge||||0.2473
72563465|NCT00442546|144658181|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0239||95.0|||||Cochran-Mantel-Haenszel|||Discharge||||0.0239
72370580|NCT00488683|144251633|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|-0.11||||0.67||95.0|||||Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccination and rise from pre-booster levels in serogroup specific IgG concentration one month after booster vaccination for the serogroup Y||||0.67
72563466|NCT00442546|144658181|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6118||95.0|||||Cochran-Mantel-Haenszel|||Week 2||||0.6118
72563467|NCT00442546|144658181|SUPERIORITY_OR_OTHER_LEGACY|||||||0.673||95.0|||||Cochran-Mantel-Haenszel|||Week 2||||0.6730
72460809|NCT00936065|144444427|SUPERIORITY_OR_OTHER|||||||0.1961|TWO_SIDED||||||Fisher Exact|||Overall treatment difference at Week 8||||0.1961
72460810|NCT00936065|144444427|SUPERIORITY_OR_OTHER|||||||0.0272|TWO_SIDED||||||Fisher Exact|||Overall treatment difference at Week 12||||0.0272
72460811|NCT00936065|144444427|SUPERIORITY_OR_OTHER|||||||0.5038|TWO_SIDED||||||Fisher Exact|||Overall treatment difference at Week 18||||0.5038
72460812|NCT00936065|144444427|SUPERIORITY_OR_OTHER|||||||0.0374|TWO_SIDED||||||Fisher Exact|||Overall treatment difference at Week 24||||0.0374
72460813|NCT00936065|144444428|SUPERIORITY_OR_OTHER|||||||0.6061|TWO_SIDED||||||Fisher Exact|||Overall treatment difference at Baseline||||0.6061
72460814|NCT00936065|144444428|SUPERIORITY_OR_OTHER|||||||0.2971|TWO_SIDED||||||Fisher Exact|||Overall treatment difference at Week 2||||0.2971
72460815|NCT00936065|144444428|SUPERIORITY_OR_OTHER|||||||0.1119|TWO_SIDED||||||Fisher Exact|||Overall treatment difference at Week 4||||0.1119
72460816|NCT00936065|144444428|SUPERIORITY_OR_OTHER|||||||0.1081|TWO_SIDED||||||Fisher Exact|||Overall treatment difference at Week 8||||0.1081
72460817|NCT00936065|144444428|SUPERIORITY_OR_OTHER|||||||0.0063|TWO_SIDED||||||Fisher Exact|||Overall treatment difference at Week 12||||0.0063
72563468|NCT00442546|144658181|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5954||95.0|||||Cochran-Mantel-Haenszel|||Week 4||||0.5954
72563469|NCT00442546|144658181|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7784||95.0|||||Cochran-Mantel-Haenszel|||Week 4||||0.7784
72563470|NCT00442546|144658181|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7293||95.0|||||Cochran-Mantel-Haenszel|||Week 6/ET||||0.7293
72392697|NCT01218204|144292591|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.296|||||TWO_SIDED|95.0|-0.9063|0.3141|||||Statistical analysis was performed using LS mean value of Atorvastatin|||0.3141|-0.9063|
72460818|NCT00936065|144444428|SUPERIORITY_OR_OTHER|||||||0.0055|TWO_SIDED||||||Fisher Exact|||Overall treatment difference at Week 18||||0.0055
72460819|NCT00936065|144444428|SUPERIORITY_OR_OTHER|||||||0.0031|TWO_SIDED||||||Fisher Exact|||Overall treatment difference at Week 24||||0.0031
72563471|NCT00442546|144658181|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5202||95.0|||||Cochran-Mantel-Haenszel|||Week 6/ET||||0.5202
72563472|NCT00442546|144658182|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1509||95.0|||||Cochran-Mantel-Haenszel|||Month 3||||0.1509
72563473|NCT00442546|144658182|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3822||95.0|||||Cochran-Mantel-Haenszel|||Month 3||||0.3822
72563474|NCT00442546|144658182|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2825||95.0|||||Cochran-Mantel-Haenszel|||Month 6||||0.2825
72563475|NCT00442546|144658182|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7733||95.0|||||Cochran-Mantel-Haenszel|||Month 6||||0.7733
72460820|NCT00936065|144444429|SUPERIORITY_OR_OTHER|||||||0.0033|TWO_SIDED||||||Log Rank|||Overall treatment difference||||0.0033
72460821|NCT00936065|144444430|SUPERIORITY_OR_OTHER|||||||0.0448|TWO_SIDED||||||Log Rank|||Overall treatment difference||||0.0448
72460822|NCT00936065|144444431|SUPERIORITY_OR_OTHER|||||||0.0041|TWO_SIDED||||||Log Rank|||Overall treatment difference||||0.0041
72460823|NCT00936065|144444432|SUPERIORITY_OR_OTHER|||||||0.3536|TWO_SIDED||||||Log Rank|||Overall treatment difference||||0.3536
72460824|NCT00936065|144444433|SUPERIORITY_OR_OTHER|||||||0.0203|TWO_SIDED||||||ANCOVA|||Overall treatment difference at Week 2||||0.0203
72460825|NCT00936065|144444433|SUPERIORITY_OR_OTHER|||||||0.0102|TWO_SIDED||||||ANCOVA|||Overall treatment difference at Week 4||||0.0102
72460826|NCT00936065|144444433|SUPERIORITY_OR_OTHER|||||||0.0056|TWO_SIDED||||||ANCOVA|||Overall treatment difference at Week 8||||0.0056
72460827|NCT00936065|144444433|SUPERIORITY_OR_OTHER|||||||0.0006|TWO_SIDED||||||ANCOVA|||Overall treatment difference at Week 12||||0.0006
72460828|NCT00936065|144444433|SUPERIORITY_OR_OTHER|||||||0.0066|TWO_SIDED||||||ANCOVA|||Overall treatment difference at Week 18||||0.0066
72460829|NCT00936065|144444433|SUPERIORITY_OR_OTHER|||||||0.0058|TWO_SIDED||||||ANCOVA|||Overall treatment difference at Week 24||||0.0058
72460830|NCT00936065|144444434|SUPERIORITY_OR_OTHER|||||||0.0329|TWO_SIDED||||||ANCOVA|||Overall treatment difference at Week 2||||0.0329
72460831|NCT00936065|144444434|SUPERIORITY_OR_OTHER|||||||0.0003|TWO_SIDED||||||ANCOVA|||Overall treatment difference at Week 4||||0.0003
72460832|NCT00936065|144444434|SUPERIORITY_OR_OTHER|||||||0.0598|TWO_SIDED||||||ANCOVA|||Overall treatment difference at Week 8||||0.0598
72460833|NCT00936065|144444434|SUPERIORITY_OR_OTHER|||||||0.0241|TWO_SIDED||||||ANCOVA|||Overall treatment difference at Week 12||||0.0241
72563476|NCT00248170|144658184|SUPERIORITY_OR_OTHER|||||||0.315|||||||Log Rank|||||||0.3150
72460834|NCT00936065|144444434|SUPERIORITY_OR_OTHER|||||||0.0543|TWO_SIDED||||||ANCOVA|||Overall treatment difference at Week 18||||0.0543
72460835|NCT00936065|144444434|SUPERIORITY_OR_OTHER|||||||0.1205|TWO_SIDED||||||ANCOVA|||Overall treatment difference at Week 24||||0.1205
72460836|NCT00936065|144444435|SUPERIORITY_OR_OTHER|||||||0.1385|TWO_SIDED||||||ANCOVA|||Overall treatment difference at Week 2||||0.1385
72460837|NCT00936065|144444435|SUPERIORITY_OR_OTHER|||||||0.0019|TWO_SIDED||||||ANCOVA|||Overall treatment difference at Week 4||||0.0019
72460838|NCT00936065|144444435|SUPERIORITY_OR_OTHER|||||||0.0442|TWO_SIDED||||||ANCOVA|||Overall treatment difference at Week 8||||0.0442
72460839|NCT00936065|144444435|SUPERIORITY_OR_OTHER|||||||0.0034|TWO_SIDED||||||ANCOVA|||Overall treatment difference at Week 12||||0.0034
72460840|NCT00936065|144444435|SUPERIORITY_OR_OTHER|||||||0.0454|TWO_SIDED||||||ANCOVA|||Overall treatment difference at Week 18||||0.0454
72460841|NCT00936065|144444435|SUPERIORITY_OR_OTHER|||||||0.0539|TWO_SIDED||||||ANCOVA|||Overall treatment difference at Week 24||||0.0539
72460842|NCT00936065|144444436|SUPERIORITY_OR_OTHER|||||||0.1723|TWO_SIDED||||||ANCOVA|||Overall treatment difference at Week 2||||0.1723
72460843|NCT00936065|144444436|SUPERIORITY_OR_OTHER|||||||0.0292|TWO_SIDED||||||ANCOVA|||Overall treatment difference at Week 4||||0.0292
72460844|NCT00936065|144444436|SUPERIORITY_OR_OTHER|||||||0.0908|TWO_SIDED||||||ANCOVA|||Overall treatment difference at Week 8||||0.0908
72460845|NCT00936065|144444436|SUPERIORITY_OR_OTHER|||||||0.5678|TWO_SIDED||||||ANCOVA|||Overall treatment difference at Week 12||||0.5678
72460846|NCT00936065|144444436|SUPERIORITY_OR_OTHER|||||||0.482|TWO_SIDED||||||ANCOVA|||Overall treatment difference at Week 18||||0.4820
72460847|NCT00936065|144444436|SUPERIORITY_OR_OTHER|||||||0.0394|TWO_SIDED||||||ANCOVA|||Overall treatment difference at Week 24||||0.0394
72460848|NCT00936065|144444437|SUPERIORITY_OR_OTHER|||||||0.1079|TWO_SIDED||||||ANCOVA|||Overall treatment difference at Week 2||||0.1079
72460849|NCT00936065|144444437|SUPERIORITY_OR_OTHER|||||||0.0004|TWO_SIDED||||||ANCOVA|||Overall treatment difference at Week 4||||0.0004
72460850|NCT00936065|144444437|SUPERIORITY_OR_OTHER|||||||0.0146|TWO_SIDED||||||ANCOVA|||Overall treatment difference at Week 8||||0.0146
72460851|NCT00936065|144444437|SUPERIORITY_OR_OTHER|||||||0.0019|TWO_SIDED||||||ANCOVA|||Overall treatment difference at Week 12||||0.0019
72460852|NCT00936065|144444437|SUPERIORITY_OR_OTHER|||||||0.0062|TWO_SIDED||||||ANCOVA|||Overall treatment difference at Week 18||||0.0062
72460853|NCT00936065|144444437|SUPERIORITY_OR_OTHER|||||||0.0197|TWO_SIDED||||||ANCOVA|||Overall treatment difference at Week 24||||0.0197
72460854|NCT00936065|144444438|SUPERIORITY_OR_OTHER|||||||0.1229|TWO_SIDED||||||ANCOVA|||Overall treatment difference at Week 2||||0.1229
72460855|NCT00936065|144444438|SUPERIORITY_OR_OTHER|||||||0.0136|TWO_SIDED||||||ANCOVA|||Overall treatment difference at Week 4||||0.0136
72460856|NCT00936065|144444438|SUPERIORITY_OR_OTHER|||||||0.1578|TWO_SIDED||||||ANCOVA|||Overall treatment difference at Week 8||||0.1578
72460857|NCT00936065|144444438|SUPERIORITY_OR_OTHER|||||||0.0565|TWO_SIDED||||||ANCOVA|||Overall treatment difference at Week 12||||0.0565
72460858|NCT00936065|144444438|SUPERIORITY_OR_OTHER|||||||0.0685|TWO_SIDED||||||ANCOVA|||Overall treatment difference at Week 18||||0.0685
72460859|NCT00936065|144444438|SUPERIORITY_OR_OTHER|||||||0.0493|TWO_SIDED||||||ANCOVA|||Overall treatment difference at Week 24||||0.0493
72460860|NCT00936065|144444439|SUPERIORITY_OR_OTHER|||||||0.3112|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 2||||0.3112
72460861|NCT00936065|144444439|SUPERIORITY_OR_OTHER|||||||0.0196|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 4||||0.0196
72460862|NCT00936065|144444439|SUPERIORITY_OR_OTHER|||||||0.0109|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 8||||0.0109
72460863|NCT00936065|144444439|SUPERIORITY_OR_OTHER|||||||0.0035|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 12||||0.0035
72460864|NCT00936065|144444439|SUPERIORITY_OR_OTHER|||||||0.0603|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 18||||0.0603
72460865|NCT00936065|144444439|SUPERIORITY_OR_OTHER|||||||0.2184|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 24||||0.2184
72460866|NCT00936065|144444440|SUPERIORITY_OR_OTHER|||||||0.1774|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 2||||0.1774
72460867|NCT00936065|144444440|SUPERIORITY_OR_OTHER|||||||0.1195|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 4||||0.1195
72460868|NCT00936065|144444440|SUPERIORITY_OR_OTHER|||||||0.0606|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 8||||0.0606
72563477|NCT01557582|144658192|SUPERIORITY_OR_OTHER||EDV percent difference|4.8|||||TWO_SIDED|95.0|2.24|7.56|||||Mean percent difference and 95% CI for EDV|||7.56|2.24|
72392698|NCT01218204|144292591|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.811|||||TWO_SIDED|95.0|-1.4125|-0.2098|||||Statistical analysis was performed using LS mean value of Atorvastatin|||-0.2098|-1.4125|
72392699|NCT01218204|144292591|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.422|||||TWO_SIDED|95.0|-0.9831|0.1394|||||Statistical analysis was performed using LS mean value of Atorvastatin|||0.1394|-0.9831|
72460869|NCT00936065|144444440|SUPERIORITY_OR_OTHER|||||||0.003|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 12||||0.0030
72460870|NCT00936065|144444440|SUPERIORITY_OR_OTHER|||||||0.1567|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 18||||0.1567
72460871|NCT00936065|144444440|SUPERIORITY_OR_OTHER|||||||0.2094|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 24||||0.2094
72460872|NCT00936065|144444441|SUPERIORITY_OR_OTHER|||||||0.0302|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 2||||0.0302
72460873|NCT00936065|144444441|SUPERIORITY_OR_OTHER|||||||0.098|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 4||||0.0980
72460874|NCT00936065|144444441|SUPERIORITY_OR_OTHER|||||||0.0711|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 8||||0.0711
72460875|NCT00936065|144444441|SUPERIORITY_OR_OTHER|||||||0.0077|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 12||||0.0077
72460876|NCT00936065|144444441|SUPERIORITY_OR_OTHER|||||||0.1553|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 18||||0.1553
72563478|NCT01557582|144658192|SUPERIORITY_OR_OTHER||ESV percent difference|1.76|||||TWO_SIDED|95.0|-1.17|4.76|||||Mean percent difference and 95% CI for ESV|||4.76|-1.17|
72392700|NCT01218204|144292591|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.384|||||TWO_SIDED|95.0|-0.6009|-0.1669|||||Statistical analysis was performed using LS mean value of Atorvastatin|||-0.1669|-0.6009|
72460877|NCT00936065|144444441|SUPERIORITY_OR_OTHER|||||||0.041|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 24||||0.0410
72460878|NCT00936065|144444442|SUPERIORITY_OR_OTHER|||||||0.006|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 2||||0.0060
72460879|NCT00936065|144444442|SUPERIORITY_OR_OTHER|||||||0.0058|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 4||||0.0058
72460880|NCT00936065|144444442|SUPERIORITY_OR_OTHER|||||||0.0127|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 8||||0.0127
72460881|NCT00936065|144444442|SUPERIORITY_OR_OTHER|||||||0.0068|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 12||||0.0068
72460882|NCT00936065|144444442|SUPERIORITY_OR_OTHER|||||||0.0096|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 18||||0.0096
72460883|NCT00936065|144444442|SUPERIORITY_OR_OTHER|||||||0.0132|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 24||||0.0132
72460884|NCT00936065|144444443|SUPERIORITY_OR_OTHER|||||||0.6904|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 2||||0.6904
72460885|NCT00936065|144444443|SUPERIORITY_OR_OTHER|||||||0.7021|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 4||||0.7021
72460886|NCT00936065|144444443|SUPERIORITY_OR_OTHER|||||||0.2199|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 8||||0.2199
72460887|NCT00936065|144444443|SUPERIORITY_OR_OTHER|||||||0.5071|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 12||||0.5071
72460888|NCT00936065|144444443|SUPERIORITY_OR_OTHER|||||||0.4765|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 18||||0.4765
72460889|NCT00936065|144444443|SUPERIORITY_OR_OTHER|||||||0.8662|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 24||||0.8662
72460890|NCT00936065|144444444|SUPERIORITY_OR_OTHER|||||||0.1144|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 2||||0.1144
72460891|NCT00936065|144444444|SUPERIORITY_OR_OTHER|||||||0.4509|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 4||||0.4509
72460892|NCT00936065|144444444|SUPERIORITY_OR_OTHER|||||||0.435|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 8||||0.4350
72460893|NCT00936065|144444444|SUPERIORITY_OR_OTHER|||||||0.6085|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 12||||0.6085
72392701|NCT01218204|144292591|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.648|||||TWO_SIDED|95.0|-1.1657|-0.1302|||||Statistical analysis was performed using LS mean value of GSK1292263|||-0.1302|-1.1657|
72392702|NCT01218204|144292591|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.782|||||TWO_SIDED|95.0|-1.2804|-0.2844|||||Statistical analysis was performed using LS mean value of GSK1292263|||-0.2844|-1.2804|
72392703|NCT01218204|144292591|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.884|||||TWO_SIDED|95.0|-1.3652|-0.4026|||||Statistical analysis was performed using LS mean value of GSK1292263|||-0.4026|-1.3652|
72392704|NCT00489541|144292610|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.42|||<|0.0001|TWO_SIDED|95.0|-0.54|-0.3|||t-test, 2 sided|||A superiority test of TAXUX Element vs bare metal (BMS) Express historical control. The null hypothesis that the true difference in means (TAXUS Element - BMS Express) is equal to zero was tested against the two-sided alternative that the true difference in means is different from zero. A sample size of 224 patients in the TAXUS Element group (190 after 15% attrition due to angiographic follow-up) provided 85% power.||-0.30|-0.54|<0.0001
72460894|NCT00936065|144444444|SUPERIORITY_OR_OTHER|||||||0.2582|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 18||||0.2582
72460895|NCT00936065|144444444|SUPERIORITY_OR_OTHER|||||||0.549|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 24||||0.5490
72460896|NCT00936065|144444445|SUPERIORITY_OR_OTHER|||||||0.3287|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 2||||0.3287
72460897|NCT00936065|144444445|SUPERIORITY_OR_OTHER|||||||0.4149|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 4||||0.4149
72460898|NCT00936065|144444445|SUPERIORITY_OR_OTHER|||||||0.3837|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 8||||0.3837
72460899|NCT00936065|144444445|SUPERIORITY_OR_OTHER|||||||0.6777|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 12||||0.6777
72460900|NCT00936065|144444445|SUPERIORITY_OR_OTHER|||||||0.4976|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 18||||0.4976
72460901|NCT00936065|144444445|SUPERIORITY_OR_OTHER|||||||0.4189|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 24||||0.4189
72460902|NCT00936065|144444446|SUPERIORITY_OR_OTHER|||||||0.476|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 2||||0.4760
72460903|NCT00936065|144444446|SUPERIORITY_OR_OTHER|||||||0.404|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 4||||0.4040
72563479|NCT01557582|144658192|SUPERIORITY_OR_OTHER||EF percent difference|2.03|||||TWO_SIDED|95.0|0.72|3.33|||||Mean percent difference and 95% CI for EF|||3.33|0.72|
72460904|NCT00936065|144444446|SUPERIORITY_OR_OTHER|||||||0.4753|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 8||||0.4753
72460905|NCT00936065|144444446|SUPERIORITY_OR_OTHER|||||||0.5084|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 12||||0.5084
72460906|NCT00936065|144444446|SUPERIORITY_OR_OTHER|||||||0.2293|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 18||||0.2293
72460907|NCT00936065|144444446|SUPERIORITY_OR_OTHER|||||||0.3822|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 24||||0.3822
72460908|NCT00936065|144444447|SUPERIORITY_OR_OTHER|||||||0.2691|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 2||||0.2691
72460909|NCT00936065|144444447|SUPERIORITY_OR_OTHER|||||||0.0142|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 4||||0.0142
72460910|NCT00936065|144444447|SUPERIORITY_OR_OTHER|||||||0.0383|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 8||||0.0383
72501359|NCT03464045|144532389|OTHER||Hazard Ratio (HR)|0.89||||0.606|TWO_SIDED|95.0|0.57|1.38|||Regression, Cox||Base hazard ratio of empagliflozin/DPP-4i|"Base HRs were calculated using a Cox proportional hazards model by adjusting for variables unbalanced after PS matching. To be included in the Cox model, each covariate is required to have a minimum of 5 events per category level to avoid converge failure.~Country-level HRs were analyzed separately. Thereafter, random-effects meta-analyses were conducted to pool the HRs from all countries, accounting for potential heterogeneity between the country-level effect sizes."||1.38|0.57|0.606
72370581|NCT00488683|144251633|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|-0.002||||0.99||95.0|||||Parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Pearson correlation coefficient between memory B cells one month after primary vaccination and rise from pre-booster levels in serogroup specific IgG concentration one month after booster vaccination for the serogroup Y||||0.99
72370582|NCT00488683|144251633|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.11||||0.62||95.0|||||Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccination and rise from pre-booster levels in serogroup specific IgG concentration one month after booster vaccination for the serogroup A||||0.62
72460911|NCT00936065|144444447|SUPERIORITY_OR_OTHER|||||||0.0026|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 12||||0.0026
72460912|NCT00936065|144444447|SUPERIORITY_OR_OTHER|||||||0.0475|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 18||||0.0475
72460913|NCT00936065|144444447|SUPERIORITY_OR_OTHER|||||||0.0205|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 24||||0.0205
72460914|NCT00936065|144444448|SUPERIORITY_OR_OTHER|||||||0.0512|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 2||||0.0512
72460915|NCT00936065|144444448|SUPERIORITY_OR_OTHER|||||||0.0024|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 4||||0.0024
72460916|NCT00936065|144444448|SUPERIORITY_OR_OTHER|||||||0.0946|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 8||||0.0946
72460917|NCT00936065|144444448|SUPERIORITY_OR_OTHER|||||||0.0935|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 12||||0.0935
72460918|NCT00936065|144444448|SUPERIORITY_OR_OTHER|||||||0.2073|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 18||||0.2073
72460919|NCT00936065|144444448|SUPERIORITY_OR_OTHER|||||||0.3415|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 24||||0.3415
72460920|NCT00936065|144444449|SUPERIORITY_OR_OTHER|||||||0.0202|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 2||||0.0202
72460921|NCT00936065|144444449|SUPERIORITY_OR_OTHER|||||||0.009|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 4||||0.0090
72460922|NCT00936065|144444449|SUPERIORITY_OR_OTHER|||||||0.0742|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 8||||0.0742
72460923|NCT00936065|144444449|SUPERIORITY_OR_OTHER|||||||0.0445|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 12||||0.0445
72460924|NCT00936065|144444449|SUPERIORITY_OR_OTHER|||||||0.2211|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 18||||0.2211
72460925|NCT00936065|144444449|SUPERIORITY_OR_OTHER|||||||0.1982|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 24||||0.1982
72460926|NCT00936065|144444450|SUPERIORITY_OR_OTHER|||||||0.0409|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 2||||0.0409
72370583|NCT00488683|144251633|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.17||||0.36||95.0|||||Non-parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Spearman correlation coefficient between memory B cells one month after primary vaccination and rise from pre-booster levels in serogroup specific IgG concentration one month after booster vaccination for the serogroup A||||0.36
72370584|NCT00488683|144251633|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|-0.003||||0.99||95.0|||||Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccination and rise from pre-booster levels in serogroup specific IgG concentration one month after booster vaccination for the serogroup C||||0.99
72370585|NCT00488683|144251633|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|-0.2||||0.24||95.0|||||Non-parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Spearman correlation coefficient between memory B cells one month after primary vaccination and rise from pre-booster levels in serogroup specific IgG concentration one month after booster vaccination for the serogroup C||||0.24
72460927|NCT00936065|144444450|SUPERIORITY_OR_OTHER|||||||0.145|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 4||||0.1450
72460928|NCT00936065|144444450|SUPERIORITY_OR_OTHER|||||||0.201|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 8||||0.2010
72460929|NCT00936065|144444450|SUPERIORITY_OR_OTHER|||||||0.0424|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 12||||0.0424
72460930|NCT00936065|144444450|SUPERIORITY_OR_OTHER|||||||0.009|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 18||||0.0090
72460931|NCT00936065|144444450|SUPERIORITY_OR_OTHER|||||||0.0116|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 24||||0.0116
72460932|NCT00936065|144444451|SUPERIORITY_OR_OTHER|||||||0.3355|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 2||||0.3355
72460933|NCT00936065|144444451|SUPERIORITY_OR_OTHER|||||||0.0341|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 4||||0.0341
72460934|NCT00936065|144444451|SUPERIORITY_OR_OTHER|||||||0.0899|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 8||||0.0899
72460935|NCT00936065|144444451|SUPERIORITY_OR_OTHER|||||||0.0062|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 12||||0.0062
72460936|NCT00936065|144444451|SUPERIORITY_OR_OTHER|||||||0.1241|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 18||||0.1241
72460937|NCT00936065|144444451|SUPERIORITY_OR_OTHER|||||||0.0393|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 24||||0.0393
72460938|NCT00936065|144444452|SUPERIORITY_OR_OTHER|||||||0.3402|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 2||||0.3402
72460939|NCT00936065|144444452|SUPERIORITY_OR_OTHER|||||||0.1184|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 4||||0.1184
72460940|NCT00936065|144444452|SUPERIORITY_OR_OTHER|||||||0.0104|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 8||||0.0104
72460941|NCT00936065|144444452|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 12||||0.0010
72460942|NCT00936065|144444452|SUPERIORITY_OR_OTHER|||||||0.025|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 18||||0.0250
72460943|NCT00936065|144444452|SUPERIORITY_OR_OTHER|||||||0.041|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 24||||0.0410
72460944|NCT00936065|144444453|SUPERIORITY_OR_OTHER|||||||0.0894|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 2||||0.0894
72460945|NCT00936065|144444453|SUPERIORITY_OR_OTHER|||||||0.0084|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 4||||0.0084
72460946|NCT00936065|144444453|SUPERIORITY_OR_OTHER|||||||0.0727|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 8||||0.0727
72460947|NCT00936065|144444453|SUPERIORITY_OR_OTHER|||||||0.0337|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 12||||0.0337
72460948|NCT00936065|144444453|SUPERIORITY_OR_OTHER|||||||0.138|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 18||||0.1380
72460949|NCT00936065|144444453|SUPERIORITY_OR_OTHER|||||||0.3415|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 24||||0.3415
72460950|NCT00936065|144444454|SUPERIORITY_OR_OTHER|||||||0.4407|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 2||||0.4407
72460951|NCT00936065|144444454|SUPERIORITY_OR_OTHER|||||||0.1768|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 4||||0.1768
72460952|NCT00936065|144444454|SUPERIORITY_OR_OTHER|||||||0.4636|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 8||||0.4636
72460953|NCT00936065|144444454|SUPERIORITY_OR_OTHER|||||||0.334|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 12||||0.3340
72460954|NCT00936065|144444454|SUPERIORITY_OR_OTHER|||||||0.1785|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 18||||0.1785
72460955|NCT00936065|144444454|SUPERIORITY_OR_OTHER|||||||0.7428|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 24||||0.7428
72460956|NCT00936065|144444455|SUPERIORITY_OR_OTHER|||||||0.5377|TWO_SIDED||||||Fisher Exact|||Overall treatment difference at Baseline||||0.5377
72460957|NCT00936065|144444455|SUPERIORITY_OR_OTHER|||||||0.1419|TWO_SIDED||||||Fisher Exact|||Overall treatment difference at Week 2||||0.1419
72460958|NCT00936065|144444455|SUPERIORITY_OR_OTHER|||||||0.5391|TWO_SIDED||||||Fisher Exact|||Overall treatment difference at Week 4||||0.5391
72460959|NCT00936065|144444455|SUPERIORITY_OR_OTHER|||||||0.2589|TWO_SIDED||||||Fisher Exact|||Overall treatment difference at Week 8||||0.2589
72460960|NCT00936065|144444455|SUPERIORITY_OR_OTHER|||||||0.0635|TWO_SIDED||||||Fisher Exact|||Overall treatment difference at Week 12||||0.0635
72460961|NCT00936065|144444455|SUPERIORITY_OR_OTHER|||||||0.1172|TWO_SIDED||||||Fisher Exact|||Overall treatment difference at Week 18||||0.1172
72460962|NCT00936065|144444455|SUPERIORITY_OR_OTHER|||||||0.1247|TWO_SIDED||||||Fisher Exact|||Overall treatment difference at Week 24||||0.1247
72460963|NCT00936065|144444456|SUPERIORITY_OR_OTHER|||||||0.9429|TWO_SIDED||||||Fisher Exact|||Overall treatment difference at Baseline||||0.9429
72460964|NCT00936065|144444456|SUPERIORITY_OR_OTHER|||||||0.0927|TWO_SIDED||||||Fisher Exact|||Overall treatment difference at Week 2||||0.0927
72460965|NCT00936065|144444456|SUPERIORITY_OR_OTHER|||||||0.0151|TWO_SIDED||||||Fisher Exact|||Overall treatment difference at Week 4||||0.0151
72460966|NCT00936065|144444456|SUPERIORITY_OR_OTHER|||||||0.1124|TWO_SIDED||||||Fisher Exact|||Overall treatment difference at Week 8||||0.1124
72460967|NCT00936065|144444456|SUPERIORITY_OR_OTHER|||||||0.0242|TWO_SIDED||||||Fisher Exact|||Overall treatment difference at Week 12||||0.0242
72460968|NCT00936065|144444456|SUPERIORITY_OR_OTHER|||||||0.0237|TWO_SIDED||||||Fisher Exact|||Overall treatment difference at Week 18||||0.0237
72460969|NCT00936065|144444456|SUPERIORITY_OR_OTHER|||||||0.0176|TWO_SIDED||||||Fisher Exact|||Overall treatment difference at Week 24||||0.0176
72460970|NCT02389894|144444457|SUPERIORITY||Risk Difference (RD)|6.9||||0.22|TWO_SIDED|95.0|-4.2|17.9|||Chi-squared|The primary end point analysis used an iterative hot-deck multiple imputation approach, assuming a nonignorable missing data mechanism.|The absolute difference in the percentage of patients with freedom from clinical or radiographic central nervous system (CNS) infarction was computed as Embol-x minus control|A sample size of 165 patients in each group ensured that each comparison had a power of approximately 90% to detect a between-group difference of 17.5% from an assumed control rate of 50% in the incidence of postoperative CNS infarcts. A single interim analysis was prespecified and performed. Based on the recommendation of the DSMB, randomization but not follow-up was halted due to low conditional power of observing any between-group differences for the primary endpoint.||17.9|-4.2|0.22
72501360|NCT03464045|144532389|OTHER||Hazard Ratio (HR)|0.89||||0.609|TWO_SIDED|95.0|0.57|1.38|||Regression, Cox||Adjusted hazard ratio of empagliflozin/DPP-4i|Adjusted HRs were calculated using a Cox proportional hazards model by adjusting for variables unbalanced after PS matching, and pre-specified time-varying covariates. To be included in the Cox model, each covariate is required to have a minimum of 5 events per category level. Country-level HRs were analyzed separately. Thereafter, random-effects meta-analyses were conducted to pool the HRs from all countries, accounting for potential heterogeneity between the country-level effect sizes.||1.38|0.57|0.609
72460971|NCT02389894|144444457|SUPERIORITY||Risk Difference (RD)|1.3||||0.84|TWO_SIDED|95.0|-11.2|13.8||The primary end point analysis used an iterative hot-deck multiple imputation approach, assuming a nonignorable missing data mechanism.|Chi-squared||The absolute difference in the percentage of patients with freedom from clinical or radiographic central nervous system (CNS) infarction was computed as Cardiogard minus control.|A sample size of 165 patients in each group ensured that each comparison had a power of approximately 90% to detect a between-group difference of 17.5% from an assumed control rate of 50% in the incidence of postoperative CNS infarcts. A single interim analysis was prespecified and performed. Based on the recommendation of the DSMB, randomization but not follow-up was halted due to low conditional power of observing any between-group differences for the primary endpoint.||13.8|-11.2|0.84
72460972|NCT02389894|144444458|SUPERIORITY||Risk Difference (RD)|9.7||||0.08|TWO_SIDED|95.0|-1.2|20.5|||Chi-squared||The absolute difference was computed as Embol-x minus control|||20.5|-1.2|0.08
72460973|NCT02389894|144444458|SUPERIORITY||Risk Difference (RD)|-2.8||||0.61|TWO_SIDED|95.0|-13.5|7.9|||Chi-squared||The absolute difference was computed as Cardiogard minus control|||7.9|-13.5|0.61
72460974|NCT00145496|144444479|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7177||95.0||||The test of hypothesis was a 2-tailed test with alpha=0.05 (0.049 to adjust for one interim analysis).|Mixed Model for Repeated Measurements|||The null hypothesis was that there was no difference in change from baseline in NSA Scale total score between asenapine and olanzapine at Day 182.||||0.7177
72460975|NCT00145496|144444480|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0565||95.0||||The test of hypothesis was a 2-tailed test with alpha=0.025 nominal significance using the Bonferroni adjustment to account for multiplicity of the key secondary comparisons.|Mixed Model for Repeated Measurements|||The null hypothesis was that there was no difference in change from baseline in QLS total score between asenapine and olanzapine at Day 182.||||0.0565
72460976|NCT00145496|144444481|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0||||The test of hypothesis was a 2-tailed test with alpha=0.025 nominal significance using the Bonferroni adjustment to account for multiplicity of the key secondary comparisons.|Mixed Model for Repeated Measurements|||The null hypothesis was that there was no difference in change from baseline in body weight between asenapine and olanzapine at Day 182.||||<0.0001
72460977|NCT01052714|144444485|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<.001
72370586|NCT00488683|144251633|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.11||||0.62||95.0|||||Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccination and rise from pre-booster levels in serogroup specific IgG concentration one month after booster vaccination for the serogroup W-135||||0.62
72460978|NCT01052714|144444486|SUPERIORITY|||||||0.718|||||||Mixed Models Analysis|||||||0.718
72460979|NCT01052714|144444487|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<.001
72460980|NCT01052714|144444488|SUPERIORITY|||||||0.676|||||||Mixed Models Analysis|||||||0.676
72460981|NCT01052714|144444489|SUPERIORITY|||||||0.141|||||||Mixed Models Analysis|||||||0.141
72460982|NCT01052714|144444490|SUPERIORITY|||||||0.92|||||||Mixed Models Analysis|||||||0.92
72460983|NCT01052714|144444491|SUPERIORITY|||||||0.322|||||||Mixed Models Analysis|||||||0.322
72460984|NCT01052714|144444492|SUPERIORITY|||||||0.652|||||||Mixed Models Analysis|||||||0.652
72460985|NCT01052714|144444493|SUPERIORITY|||||||0.663|||||||Mixed Models Analysis|||||||0.663
72460986|NCT01052714|144444494|SUPERIORITY|||||||0.9|||||||Mixed Models Analysis|||||||0.9
72460987|NCT01052714|144444495|SUPERIORITY|||||||0.415|||||||Mixed Models Analysis|||||||0.415
72460988|NCT01052714|144444496|SUPERIORITY|||||||0.687|||||||Mixed Models Analysis|||||||0.687
72460989|NCT01052714|144444497|SUPERIORITY|||||||0.22|||||||Mixed Models Analysis|||||||0.22
72460990|NCT01052714|144444498|SUPERIORITY|||||||0.059|||||||Mixed Models Analysis|||||||0.059
72460991|NCT01052714|144444499|SUPERIORITY|||||||0.79|||||||Mixed Models Analysis|||||||0.79
72460992|NCT01052714|144444500|SUPERIORITY|||||||0.146|||||||Mixed Models Analysis|||||||0.146
72460993|NCT01052714|144444501|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<.001
72460994|NCT01052714|144444502|SUPERIORITY|||||||0.763|||||||Mixed Models Analysis|||||||0.763
72460995|NCT02168153|144444503|SUPERIORITY||Mean Difference (Final Values)|-3.49||||0.76|TWO_SIDED|95.0|-25.75|18.77|||ANCOVA|adjusted for age||Between group differences||18.77|-25.75|0.76
72460996|NCT02168153|144444504|SUPERIORITY||Mean Difference (Final Values)|0.97||||0.92|TWO_SIDED|95.0|-18.04|19.98|||ANCOVA|adjusted for age||Between group differences||19.98|-18.04|0.92
72460997|NCT02168153|144444505|SUPERIORITY||Mean Difference (Final Values)|3.49||||0.7|TWO_SIDED|95.0|-14.4|21.39|||ANCOVA|adjusted for age||Between group differences||21.39|-14.4|0.70
72460998|NCT02168153|144444506|SUPERIORITY||Mean Difference (Final Values)|0.988||||0.15|TWO_SIDED|95.0|-0.373|2.349|||ANCOVA|adjusted for age||Between group differences||2.349|-0.373|0.15
72460999|NCT02168153|144444507|SUPERIORITY||Mean Difference (Final Values)|-0.41||||0.32|TWO_SIDED|95.0|-1.24|0.41|||ANCOVA|adjusted for age||Between group differences||0.41|-1.24|0.32
72461000|NCT03530345|144444537|SUPERIORITY||Mean Difference (Net)|-1.07|STANDARD_ERROR_OF_MEAN|0.404||0.0111|TWO_SIDED|95.0|-1.89|-0.26||2-sided p-value for testing superiority of neridronic acid 400 mg compared to placebo.|Mixed Models Analysis|The degrees of freedom of the denominator are estimated using the Kenward-Roger approximation.|The primary endpoint estimate was the least squares mean differences of change from baseline in pain NRS (electronic diary) at Week 12 between neridronate and Placebo.|Mixed-effects model for repeated measures (MMRM) defined with baseline pain intensity as covariate, the factors geographic region, week, treatment and treatment-by-week as fixed effects, and an unstructured covariance matrix to model the covariance structure of the repeated measurements.||-0.26|-1.89|0.0111
72501361|NCT01773473|144532455|NON_INFERIORITY_OR_EQUIVALENCE|Analyses were based on a pre-defined non-inferiority margin of 0.4%.|Mean Difference (Net)|0.17|||||TWO_SIDED|95.0|-0.01|0.35||||||||0.35|-0.01|
72461001|NCT01184755|144444553|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.561256|STANDARD_ERROR_OF_MEAN|0.216403||0.01|TWO_SIDED|95.0|-0.987999|-0.134513||This is an intention-to-treat analysis|Mixed effects regression analysis|||This is the change in Systolic BP at 8 weeks||-.134513|-.987999|.01
72461002|NCT01184755|144444553|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.391195|STANDARD_ERROR_OF_MEAN|0.140034||0.006|TWO_SIDED|95.0|-0.667312|-0.115079|||mixed effects regression analysis|||This is the analysis of change in diastolic BP from Ambulatory BP monitoring.||-.115079|-.667312|.006
72461003|NCT00318591|144444554|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The additional explanatory variables were removed using backwards-elimination removing the least significant additional variable for each iteration, until the effect of all included additional variables was significant on α=0.05 significant level. The null-hypothesis of no catheter difference was to be rejected on α=0.05 significant level.|Hazard Ratio (HR)|1.502||||0.0383|TWO_SIDED|95.0|1.022|2.207||p-value is adjusted for the following explanatory variables: catheterization frequency, technique (clean/sterile), procedure (participant/nurse), setting (hospital/community) and demographic measures.|Kaplan-Meier|||The analysis was done by comparing Kaplan-Meier estimates of the survival function of the two groups. The analysis was refined by a Cox proportional hazards regression model for survival data.||2.207|1.022|0.0383
72461004|NCT00318591|144444556|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|ANOVA analysis. Limit of significant difference \<0.05||||||0.767||95.0||||baseline characteristics were used as covariates, catheterization procedure (participant or caregiver) as well as technique (sterile or clean). Backward elimination was used.|ANOVA|||||||0.7670
72461005|NCT00318591|144444557|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|ANOVA. Level of significant difference \<0.05||||||0.0074||95.0||||baseline characteristics were used as covariates, catheterization procedure (participant or caregiver) as well as technique (sterile or clean). Backward elimination was used.|ANOVA|||||||0.0074
72461006|NCT01612221|144444563|SUPERIORITY|||||||0.65|||||||Wilcoxon (Mann-Whitney)|||||||.65
72461007|NCT01612221|144444564|SUPERIORITY|||||||0.76|||||||ANCOVA|||GCLM Biomarker analysis.||||0.76
72461008|NCT01612221|144444564|SUPERIORITY|||||||0.63|||||||ANCOVA|||SLC1A4 Biomarker analysis.||||0.63
72461009|NCT01612221|144444564|SUPERIORITY|||||||0.27|||||||ANCOVA|||SLC7A11 Biomarker analysis.||||0.27
72461010|NCT00644332|144444595|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.7|STANDARD_ERROR_OF_MEAN|0.5||||||||||||Mean change in angina frequency from Baseline to Week 4||||
72461011|NCT00644332|144444596|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.2|STANDARD_ERROR_OF_MEAN|0.5||||||||||||Mean change in NTG use from Baseline to Week 4||||
72461012|NCT00644332|144444597|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.9|STANDARD_ERROR_OF_MEAN|0.8||||||||||||||||
72461013|NCT02706834|144444605|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence interval of 0.80 to 1.25|Point estimate|0.43|||||TWO_SIDED|90.0|0.38|0.487|||||Exponentiated Least Square Means TAK-828 100 mg Fed/TAK-828 100 mg Fasted|Food Effect: A linear mixed effect model on the natural log (ln)-transformed parameters was performed with dosing condition as a fixed effect and participant as a random effect using the Kenward-Roger estimation for computing the denominator degrees of freedom. The least squares means and difference of least squared means for the ln-transformed parameters were exponentiated to obtain the geometric means on the original scale.||0.487|0.380|
72461014|NCT02706834|144444612|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence interval of 0.80 to 1.25|Point estimate|0.896|||||TWO_SIDED|90.0|0.833|0.964|||||Exponentiated Least Square Means TAK-828 100 mg Fed/TAK-828 100 mg Fasted|Food Effect: A linear mixed effect model on the natural log (ln)-transformed parameters was performed with dosing condition as a fixed effect and participant as a random effect using the Kenward-Roger estimation for computing the denominator degrees of freedom. The least squares means and difference of least squared means for the ln-transformed parameters were exponentiated to obtain the geometric means and ratios of geometric means on the original scale.||0.964|0.833|
72461015|NCT00627523|144444625|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.2|STANDARD_ERROR_OF_MEAN|0.19|<|0.001|TWO_SIDED|95.0|0.82|1.59||ANCOVA model, fitting treatment as a factor, and the baseline parameter value as covariate was used. All hypotheses were tested at a 5% level of significance.|ANCOVA|No adjustments were made for multiple comparisons.||The null hypothesis was that there was no difference in the mean change from Baseline after 24 months in height SDS between the Genotropin® and the untreated control groups. The alternative hypothesis was that there was a difference between the treatment groups.||1.59|0.82|<0.001
72501362|NCT02371629|144532517|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.033|STANDARD_ERROR_OF_MEAN|0.0169||0.051|TWO_SIDED|95.0|0.0|0.066|||Mixed model for repeated measure (MMRM)|||||0.066|0.000|0.051
72621000|NCT03766906|144773092|SUPERIORITY||Mean Difference (Final Values)|2.03||||0.003|TWO_SIDED||||||t-test, 2 sided|Within subjects paired t-tests.|Investigators tested whether pretest to posttest change was significantly greater than 0 at P \< 0.05.|||||.003
72461016|NCT00627523|144444626|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.77|STANDARD_ERROR_OF_MEAN|0.81||0.348|TWO_SIDED|95.0|-0.87|2.42||ANCOVA model, fitting treatment as a factor, and the baseline parameter value as covariate was used. All hypotheses were tested at a 5% level of significance.|ANCOVA|No adjustments were made for multiple comparisons.||The null hypothesis was that there was no difference between the Genotropin® and the untreated control group in terms of the relevant secondary endpoints. The alternative hypothesis was that a difference existed.||2.42|-0.87|0.348
72461017|NCT00627523|144444627|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.89|STANDARD_ERROR_OF_MEAN|0.17|<|0.001|TWO_SIDED|95.0|0.55|1.23||ANCOVA model, fitting treatment as a factor, and the baseline parameter value as covariate was used. All hypotheses were tested at a 5% level of significance.|ANCOVA|No adjustments were made for multiple comparisons.||The null hypothesis was that there was no difference between the Genotropin® and the untreated control group in terms of the relevant secondary endpoints. The alternative hypothesis was that a difference existed.||1.23|0.55|<0.001
72501363|NCT01440101|144532533|SUPERIORITY_OR_OTHER||||||<|0.001||||||P-value obtained from the Mann-Whitney U test stratified by the presence or absence of Gd+ lesions at baseline.|Wilcoxon (Mann-Whitney)|||||||<0.001
72501364|NCT01440101|144532536|SUPERIORITY_OR_OTHER||||||<|0.001||||||P-value obtained from the Van Elteren test stratified by the presence or absence of Gd+ lesions at baseline.|Van Elteren test|||||||<0.001
72501365|NCT01440101|144532537|SUPERIORITY_OR_OTHER|||||||0.006|||||||Wilcoxon rank sum test|||||||0.006
72621001|NCT03766906|144773093|SUPERIORITY||Mean Difference (Final Values)|1.18||||0.022|TWO_SIDED||||||t-test, 2 sided|Within subjects paired t-tests.|Investigators tested whether pre-test to post-test change was significantly greater than zero at P\<0.05.|||||.022
72392705|NCT00489541|144292611|SUPERIORITY_OR_OTHER||12-month TLR rate|7.34|||<|0.0001|ONE_SIDED|95.0||10.8|||Chi-squared|||One-sided, single-sample binomial test to compare the observed TLF rate in PERSEUS SV to the pre-specified performance goal (19.5%). The normal approximation of the test statistic was used. The null hypothesis that the true TAXUS Element TLF rate is greater than or equal to the performance goal was tested against the one-sided alternative that the true rate is less than the performance goal. A sample size of 224 patients (accounting for 5% attrition to follow-up) provided 80% power.||10.8||<0.0001
72392706|NCT03266107|144292619|SUPERIORITY||||||<|0.001|||||||t-test, 1 sided|||||||<0.001
72461018|NCT00627523|144444628|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.24|STANDARD_ERROR_OF_MEAN|0.8|<|0.001|TWO_SIDED|95.0|1.63|4.85||ANCOVA model, fitting treatment as a factor, and the baseline parameter value as covariate was used. All hypotheses were tested at a 5% level of significance.|ANCOVA|No adjustments were made for multiple comparisons.||The null hypothesis was that there was no difference between the Genotropin® and the untreated control group in terms of the relevant secondary endpoints. The alternative hypothesis was that a difference existed.||4.85|1.63|<0.001
72461019|NCT00627523|144444629|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.43|STANDARD_ERROR_OF_MEAN|7.19||0.738|TWO_SIDED|95.0|-12.27|17.12||ANCOVA model, fitting treatment as a factor, and the baseline parameter value, age, and gender as covariates were used. All hypotheses were tested at a 5% level of significance.|ANCOVA|No adjustments were made for multiple comparisons.||The null hypothesis was that there was no difference between the Genotropin® and the untreated control group in terms of the relevant secondary endpoints. The alternative hypothesis was that a difference existed.||17.12|-12.27|0.738
72461020|NCT00627523|144444630|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.51|STANDARD_ERROR_OF_MEAN|4.27||0.301|TWO_SIDED|95.0|-13.27|4.26||ANCOVA model, fitting treatment as a factor, and the baseline parameter value, age, and gender as covariates were used. All hypotheses were tested at a 5% level of significance.|ANCOVA|No adjustments were made for multiple comparisons.||The null hypothesis was that there was no difference between the Genotropin® and the untreated control group in terms of the relevant secondary endpoints. The alternative hypothesis was that a difference existed.||4.26|-13.27|0.301
72461021|NCT03602053|144444657|NON_INFERIORITY|If the lower limit of the 95% CI of the ratio of GMCs between the ROTAVAC 5D® and ROTAVAC® groups was larger than 1/2 (i.e. \> 0.5), ROTAVAC 5D® would be considered non-inferior to ROTAVAC®.|GMC ratio|1.294|||||TWO_SIDED|95.0|0.862|1.924|||t-test, 2 sided|||||1.924|0.862|
72461022|NCT01882088|144444719|EQUIVALENCE|Data were analyzed using Statistica 10 software. Wilcoxon matched pairs test of non-parametric module was used to assess changes of the studied parameters after the course of fiber supplementation in comparison to baseline. A P value of 0.05 was considered statistically significant. Sample size calculation was performed using 1-Way ANOVA. Effect size calculation was performed for every comparison.||||||2e-06|||||||Wilcoxon (Mann-Whitney)|||Data were analyzed using Statistica 10 software. Wilcoxon matched pairs test of non-parametric module was used to assess changes of the studied parameters after the course of fiber supplementation in comparison to baseline. A P value of 0.05 was considered statistically significant. Sample size calculation was performed using 1-Way ANOVA. Effect size calculation was performed for every comparison.||||0.000002
72461023|NCT01882088|144444720|EQUIVALENCE|Data were analyzed using Statistica 10 software. Wilcoxon matched pairs test of non-parametric module was used to assess changes of the studied parameters after the course of fiber supplementation in comparison to baseline. A P value of 0.05 was considered statistically significant. Sample size calculation was performed using 1-Way ANOVA. Effect size calculation was performed for every comparison.||||||0.2|||||||Wilcoxon (Mann-Whitney)|||Data were analyzed using Statistica 10 software. Wilcoxon matched pairs test of non-parametric module was used to assess changes of the studied parameters after the course of fiber supplementation in comparison to baseline. A P value of 0.05 was considered statistically significant. Sample size calculation was performed using 1-Way ANOVA. Effect size calculation was performed for every comparison.||||0.2
72501366|NCT01440101|144532538|SUPERIORITY_OR_OTHER||Difference in proportions|0.404|||<|0.001|TWO_SIDED|95.0|0.223|0.586|||Fisher Exact|||Relapse-free proportions compared using a two-sided Fisher exact test. In the analysis, participants with unknown status are considered to have relapsed.||0.586|0.223|<0.001
72621002|NCT03766906|144773094|SUPERIORITY||Mean Difference (Final Values)|1.34||||0.016|TWO_SIDED||||||t-test, 2 sided|Within subjects paired t-tests|Investigators tested whether pre-test to post-test change was significantly greater than 0 at P\<0.05.|||||.016
72621003|NCT03766906|144773095|SUPERIORITY||Mean Difference (Final Values)|0.95||||0.002|TWO_SIDED||||||t-test, 2 sided|Within subjects paired t-tests.|Investigators tested whether pre-test to post-test change was significantly greater than 0 at P\<0.05.|||||.002
72621004|NCT03766906|144773096|SUPERIORITY||Mean Difference (Final Values)|0.38||||0.626|TWO_SIDED||||||t-test, 2 sided|Within subjects paired t-tests.|Investigators tested whether pre-test to post-test change was significantly greater than 0 at P\<0.05.|The statistical analyses for the Student Self-Efficacy, in terms of type of statistical test, method, and the comments which we state within-subjects paired t-tests, are the same for each of the three subscales that make up Student Self-Efficacy (i.e., Relevance to schoolwork, Future aspirations, and Family support).||||.626
72621005|NCT03766906|144773096|SUPERIORITY||Mean Difference (Final Values)|0.05||||0.909|TWO_SIDED||||||t-test, 2 sided|Investigators tested whether pre-test to post-test change was significantly greater than 0 at P\<0.05.||The statistical analyses for the Student Self-Efficacy, in terms of type of statistical test, method, and the comments which we state within-subjects paired t-tests, are the same for each of the three subscales that make up Student Self-Efficacy (i.e., Relevance to schoolwork, Future aspirations, and Family support).||||.909
72392707|NCT03266107|144292620|SUPERIORITY||||||<|0.001|||||||t-test, 1 sided|||||||<0.001
72392708|NCT03266107|144292623|SUPERIORITY||||||<|0.001|||||||t-test, 1 sided|||||||<0.001
72392709|NCT01191801|144292675|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.87||||0.0305|ONE_SIDED|95.0||||Unstratified one sided P-Value|Unstratified Log Rank|Since the sample size was increased, the primary analysis used the weighted statistic proposed by Cui, Hung, and Wang (Cui 1999).||||||0.0305
72392710|NCT01191801|144292676|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Two sided P-Value|Chi-squared|||||||<0.0001
72392711|NCT01191801|144292679|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Two sided P-Value|Chi-squared|||||||<0.0001
72392712|NCT01191801|144292680|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.67|||<|0.0001|ONE_SIDED|95.0||||Unstratified one-sided P-Value|Log Rank|||||||<0.0001
72461024|NCT01882088|144444721|EQUIVALENCE|Data were analyzed using Statistica 10 software. Wilcoxon matched pairs test of non-parametric module was used to assess changes of the studied parameters after the course of fiber supplementation in comparison to baseline. A P value of 0.05 was considered statistically significant. Sample size calculation was performed using 1-Way ANOVA. Effect size calculation was performed for every comparison.||||||0.002415|||||||Wilcoxon (Mann-Whitney)|||||||0.002415
72392713|NCT01191801|144292681|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.89||||0.3134|TWO_SIDED|95.0||||One sided P-Value|Log Rank|||||||0.3134
72392714|NCT02221947|144292730|OTHER||mean Tmax(h)|0.92|||||TWO_SIDED||||||||SD=0.206|Bryostatin plasma concentration: mean Tmax (h)||||
72392715|NCT02221947|144292730|OTHER||mean (h*ng/mL)|1.05|||||TWO_SIDED||||||||SD=0.330|Bryostatin plasma concentration AUC0-last (h\*ng/mL)||||
72392716|NCT00114101|144292731|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|This study was designed to have 80% power, with the use of the log-rank test at a one-sided significance level of 0.05, to detect a hazard ratio of 1.4, assuming proportional hazards and an exponential time to event distribution. Under the assumed framework, 309 events were expected. The expected drop out rate before randomization was 15%.|Hazard Ratio (HR)|0.36|||<|0.001|TWO_SIDED|95.0|0.26|0.53||Participants were randomized with the use of a permuted-block design stratified by beta 2 microglobulin, prior use of thalidomide and prior use of lenalidomide. TTP was monitored with the use of a group sequential design for superiority and futility.|Log Rank|||||0.53|0.26|<0.001
72461025|NCT01882088|144444722|EQUIVALENCE|Data were analyzed using Statistica 10 software. Wilcoxon matched pairs test of non-parametric module was used to assess changes of the studied parameters after the course of fiber supplementation in comparison to baseline. A P value of 0.05 was considered statistically significant. Sample size calculation was performed using 1-Way ANOVA. Effect size calculation was performed for every comparison.||||||0.000438|||||||Wilcoxon (Mann-Whitney)|||||||0.000438
72461026|NCT01882088|144444723|EQUIVALENCE|Data were analyzed using Statistica 10 software. Wilcoxon matched pairs test of non-parametric module was used to assess changes of the studied parameters after the course of fiber supplementation in comparison to baseline. A P value of 0.05 was considered statistically significant. Sample size calculation was performed using 1-Way ANOVA. Effect size calculation was performed for every comparison.||||||0.023|||||||Wilcoxon (Mann-Whitney)|||||||0.023
72461027|NCT01882088|144444724|EQUIVALENCE|Data were analyzed using Statistica 10 software. Wilcoxon matched pairs test of non-parametric module was used to assess changes of the studied parameters after the course of fiber supplementation in comparison to baseline. A P value of 0.05 was considered statistically significant. Sample size calculation was performed using 1-Way ANOVA. Effect size calculation was performed for every comparison.||||||0.11|||||||Wilcoxon (Mann-Whitney)|||||||0.11
72461028|NCT01882088|144444725|EQUIVALENCE|Data were analyzed using Statistica 10 software. Wilcoxon matched pairs test of non-parametric module was used to assess changes of the studied parameters after the course of fiber supplementation in comparison to baseline. A P value of 0.05 was considered statistically significant. Sample size calculation was performed using 1-Way ANOVA. Effect size calculation was performed for every comparison.||||||0.008|||||||Wilcoxon (Mann-Whitney)|||||||0.008
72461029|NCT01882088|144444726|EQUIVALENCE|Data were analyzed using Statistica 10 software. Wilcoxon matched pairs test of non-parametric module was used to assess changes of the studied parameters after the course of fiber supplementation in comparison to baseline. A P value of 0.05 was considered statistically significant. Sample size calculation was performed using 1-Way ANOVA. Effect size calculation was performed for every comparison.||||||0.94|||||||Wilcoxon (Mann-Whitney)|||||||0.94
72392717|NCT00114101|144292733|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.52||||0.7|TWO_SIDED|95.0|0.26|1.02|||Log Rank|||||1.02|0.26|0.70
72461030|NCT01882088|144444727|EQUIVALENCE|Data were analyzed using Statistica 10 software. Wilcoxon matched pairs test of non-parametric module was used to assess changes of the studied parameters after the course of fiber supplementation in comparison to baseline. A P value of 0.05 was considered statistically significant. Sample size calculation was performed using 1-Way ANOVA. Effect size calculation was performed for every comparison.||||||0.37|||||||Wilcoxon (Mann-Whitney)|||||||0.37
72461031|NCT01882088|144444728|EQUIVALENCE|Data were analyzed using Statistica 10 software. Wilcoxon matched pairs test of non-parametric module was used to assess changes of the studied parameters after the course of fiber supplementation in comparison to baseline. A P value of 0.05 was considered statistically significant. Sample size calculation was performed using 1-Way ANOVA. Effect size calculation was performed for every comparison.||||||2e-05|||||||Wilcoxon (Mann-Whitney)|||||||0.00002
72461032|NCT04468633|144444729|OTHER|||||||0.687|||||||t-test, 2 sided|||Baseline||||0.687
72461033|NCT04468633|144444729|OTHER|||||||0.384|||||||t-test, 2 sided|||Day 1||||0.384
72461034|NCT04468633|144444729|OTHER|||||||0.597|||||||t-test, 2 sided|||Week 1||||0.597
72392718|NCT00114101|144292734|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.53|||<|0.001|TWO_SIDED|95.0|0.41|0.69|||Fisher Exact|||||0.69|0.41|<0.001
72392719|NCT01774604|144292744|SUPERIORITY_OR_OTHER|||||||0.33|||||||Fisher Exact|||||||0.33
72392720|NCT01774604|144292745|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||||||1.00
72392721|NCT01774604|144292746|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||||||1.00
72392722|NCT01774604|144292747|SUPERIORITY_OR_OTHER|||||||0.15|||||||Fisher Exact|||||||0.15
72392723|NCT01774604|144292748|SUPERIORITY_OR_OTHER|||||||0.75|||||||Fisher Exact|||||||0.75
72392724|NCT01774604|144292749|SUPERIORITY_OR_OTHER|||||||0.25|||||||Fisher Exact|||||||0.25
72392725|NCT01774604|144292750|SUPERIORITY_OR_OTHER|||||||0.1|||||||Fisher Exact|||||||0.10
72392726|NCT01192516|144292759|SUPERIORITY_OR_OTHER|||||||0.85|TWO_SIDED||||||Mixed Models Analysis|Adjusted for age, gender, pain level, and body mass index at baseline.||||||.85
72392727|NCT01192516|144292762|SUPERIORITY_OR_OTHER|||||||0.06|TWO_SIDED||||||Mixed Models Analysis|Adjusted for age, gender, and body mass index.||||||.06
72392728|NCT01192516|144292765|SUPERIORITY_OR_OTHER|||||||0.36|TWO_SIDED|||||Adjusted for age, gender, body mass index, and pain at baseline.|Mixed Models Analysis|||||||.36
72392729|NCT00730132|144292784|SUPERIORITY_OR_OTHER_LEGACY|||||||0.007|||||||Pearson Chi-Square|||Significance of the differences in the number of patients per group who achieved goal TC levels on Visit 2.||||0.007
72461035|NCT04468633|144444729|OTHER|||||||0.86|||||||t-test, 2 sided|||Week 4||||0.860
72392730|NCT00730132|144292785|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||Chi square, continuity corrected. Asymptotic significance.|McNemar|||Significance of paired changes in the number of patients who achieved LDL-C target levels on Visit 2, for each treatment group comparison||||<0.001
72461036|NCT04468633|144444729|OTHER|||||||0.032|||||||t-test, 2 sided|||Week 6||||0.032
72461037|NCT04468633|144444729|OTHER|||||||0.026|||||||t-test, 2 sided|||Month 3||||0.026
72461038|NCT04468633|144444729|OTHER|||||||0.172|||||||t-test, 2 sided|||Month 6||||0.172
72461039|NCT04468633|144444729|OTHER|||||||0.01|||||||t-test, 2 sided|||Year 1||||0.010
72461040|NCT04468633|144444733|OTHER|||||||0.759|||||||Wilcoxon rank sum test|||||||0.759
72461041|NCT04468633|144444734|OTHER|||||||0.603|||||||Wilcoxon rank sum test|||||||0.603
72461042|NCT04468633|144444743|OTHER|||||||0.833|||||||Wilcoxon rank sum test|||||||0.833
72461043|NCT00147745|144444778|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.04|STANDARD_ERROR_OF_MEAN|0.07||0.5499||95.0|-0.1|0.19|||ANCOVA|||||0.19|-0.10|0.5499
72461044|NCT00147745|144444778|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.09||0.5723||95.0|-0.23|0.13|||ANCOVA|||||0.13|-0.23|0.5723
72461045|NCT00147745|144444778|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.09|STANDARD_ERROR_OF_MEAN|0.091||0.3138||95.0|-0.09|0.28|||ANCOVA|||||0.28|-0.09|0.3138
72461046|NCT00147745|144444779|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.08|STANDARD_ERROR_OF_MEAN|0.065||0.2042||95.0|-0.05|0.22|||ANCOVA|||||0.22|-0.05|0.2042
72461047|NCT00147745|144444779|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.03|STANDARD_ERROR_OF_MEAN|0.083||0.6855||95.0|-0.2|0.14|||ANCOVA|||||0.14|-0.20|0.6855
72461048|NCT00147745|144444779|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.12|STANDARD_ERROR_OF_MEAN|0.085||0.1727||95.0|-0.05|0.29|||ANCOVA|||||0.29|-0.05|0.1727
72461049|NCT00147745|144444780|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-44.4|STANDARD_ERROR_OF_MEAN|53.17||0.4104||95.0|-152.8|64.1|||ANCOVA|||||64.1|-152.8|0.4104
72461050|NCT00147745|144444780|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.1|STANDARD_ERROR_OF_MEAN|69.98||0.8857||95.0|-132.6|152.9|||ANCOVA|||||152.9|-132.6|0.8857
72461051|NCT00147745|144444780|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-54.5|STANDARD_ERROR_OF_MEAN|67.08||0.4226||95.0|-191.3|82.3|||ANCOVA|||||82.3|-191.3|0.4226
72461052|NCT00147745|144444781|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.45|STANDARD_ERROR_OF_MEAN|0.366||0.2286||95.0|-1.2|0.3|||ANCOVA|||||0.30|-1.20|0.2286
72461053|NCT00147745|144444781|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.52|STANDARD_ERROR_OF_MEAN|0.515||0.3184||95.0|-0.53|1.57|||ANCOVA|||||1.57|-0.53|0.3184
72461054|NCT00147745|144444781|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.97|STANDARD_ERROR_OF_MEAN|0.5||0.0613||95.0|-1.99|0.05|||ANCOVA|||||0.05|-1.99|0.0613
72461055|NCT00147745|144444782|SUPERIORITY_OR_OTHER|||||||0.0362||95.0|||||t-test, 2 sided|||||||0.0362
72461056|NCT02389725|144444797|SUPERIORITY|||||||0.95|||||||Wilcoxon (Mann-Whitney)|||||||0.95
72461057|NCT02389725|144444798|SUPERIORITY|||||||0.87|||||||Wilcoxon (Mann-Whitney)|||||||0.87
72461058|NCT02389725|144444799|SUPERIORITY|||||||0.67|||||||Wilcoxon (Mann-Whitney)|||||||0.67
72461059|NCT02389725|144444800|SUPERIORITY|||||||0.32|||||||Wilcoxon (Mann-Whitney)|||||||0.32
72461060|NCT00724750|144444805|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin was 5%/day. For 80% power and a significance (alpha) level of 0.05; and assuming a common standard deviation of 9%, 41 subjects per group were needed.||||||0.6|TWO_SIDED|||||The rate of change for the 2 groups was compared by testing the treatment-by-time interaction in the model.|Mixed Models Analysis|||||||0.60
72461061|NCT00724750|144444806|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin was 5%/day.||||||0.19|TWO_SIDED|||||The rate of change for the 2 groups was compared by testing the treatment-by-time interaction.|Mixed Models Analysis|||||||0.19
72461062|NCT00724750|144444808|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<0.01
72461063|NCT00724750|144444809|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED||||||Mixed Models Analysis|||||||0.02
72461064|NCT00724750|144444810|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<0.01
72392731|NCT00730132|144292786|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|25.757|STANDARD_DEVIATION|12.30606||||95.0||||||||Descriptive statistics of relative (%) change in TC levels from Baseline at Visit 2||||
72461065|NCT01357564|144444863|SUPERIORITY||Mean Difference (Net)|-0.72||||0.02|TWO_SIDED|95.0|-1.23|-0.13|||t-test, 2 sided|||Sample size calculation was based on the main study hypothesis tested at 80% power for a 2-sided alternative hypothesis using a t-test comparing the treatment groups on 4-month values. Based on previous trials, we sought a medium effect size of 0.50 using a type I error rate of .05.||-0.13|-1.23|.02
72461066|NCT01357564|144444864|SUPERIORITY||Mean Difference (Net)|-0.1||||0.03|TWO_SIDED|95.0|-0.14|-0.01|||t-test, 2 sided|||Sample size calculation was based on the main study hypothesis tested at 80% power for a 2-sided alternative hypothesis using a t-test comparing the treatment groups on 4-month values. Based on previous trials, we sought a medium effect size of 0.50 using a type I error rate of .05.||-0.01|-0.14|.03
72461067|NCT02267746|144444869|EQUIVALENCE|Estimates of mean percent change from baseline were calculated (separately for inflammatory and non-inflammatory lesions) for the Test and Reference treatment, and then the 90% confidence interval (CI) for the mean ratio was constructed using Fieller's method.|Mean Difference (Net)|0.93|||||TWO_SIDED|90.0|0.86|1.02|||||Therapeutic equivalence was established if the 90% CIs for the ratio of Test/Reference means, for both lesion types, were contained within the interval \[0.80, 1.25\] for the PP population.|||1.02|0.86|
72501367|NCT01440101|144532539|SUPERIORITY_OR_OTHER|||||||0.729||||||P-value for comparison between the treated and placebo groups was based on analysis of covariance, adjusted for the baseline VAS score.|ANCOVA|||Change from Baseline to Week 12||||0.729
72461068|NCT02267746|144444870|EQUIVALENCE|Estimates of mean percent change from baseline were calculated (separately for inflammatory and non-inflammatory lesions) for the Test and Reference treatment, and then the 90% confidence interval (CI) for the mean ratio was constructed using Fieller's method.|Mean Difference (Net)|0.96|||||TWO_SIDED|90.0|0.89|1.04|||||Therapeutic equivalence was established if the 90% CIs for the ratio of Test/Reference means, for both lesion types, were contained within the interval \[0.80, 1.25\] for the PP population.|||1.04|0.89|
72461069|NCT02267746|144444871|EQUIVALENCE|Therapeutic equivalence was established if the 90% CI for the difference was contained within the interval \[-0.20, +0.20\] for PP population.|Mean Difference (Net)|-0.073|||||TWO_SIDED|90.0|-0.15|0.004|||||Therapeutic equivalence was established if the 90% CI for the difference was contained within the interval \[-0.20, +0.20\] for the PP population.|Success was defined as an IGA score at Week 12 that was at least two grades less than the baseline assessment. Failure was defined as an IGA score that was the same, higher, or one grade lower than the baseline assessment.||0.004|-0.150|
72461070|NCT00348283|144444880|SUPERIORITY_OR_OTHER|||||||0.056||||||The P value is from Cochran-Mantel-Haenszel test with clinical response (CR-70 responder status) at Week 4 as the stratification factor.|Cochran-Mantel-Haenszel|Because of the hierarchical testing scheme used for testing the ranked secondary endpoints, alpha level of 0.05 was used at each stage of testing.||ITT population: all subjects randomized at Week 4 who had at least 1 dose of blinded therapy. The sample-size (placebo = 65 subjects; adalimumab = 65 subjects) for the primary efficacy analysis was calculated using 88% power at 0.05 alpha level based on the assumption that 25% and 5% of subjects were without mucosal ulceration at Week 12 in adalimumab 40 mg eow and placebo groups, respectively. However, subjects without mucosal ulceration at Screening were excluded from the primary analysis.||||0.056
72461071|NCT00348283|144444881|SUPERIORITY_OR_OTHER|||||||0.021||||||The P value is from Cochran-Mantel-Haenszel test with clinical response (CR-70 responder status) at Week 4 as the stratification factor.|Cochran-Mantel-Haenszel|||The null hypothesis was that there is no difference in proportion of subjects with clinical remission at Week 12 in the two treatment groups.||||0.021
72392732|NCT00730132|144292786|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|20.0|STANDARD_DEVIATION|15.662||||95.0||||||||Descriptive statistics of relative (%) change in TC from baseline at Visit 2||||
72461072|NCT00348283|144444882|SUPERIORITY_OR_OTHER||||||<|0.001||||||The P value is from Cochran-Mantel-Haenszel test with clinical response (CR-70 responder status) at Week 4 as the stratification factor.|Cochran-Mantel-Haenszel|||The null hypothesis was that there is no difference between proportions of subjects without mucosal ulceration at Week 52 in the two treatment groups.||||<0.001
72461073|NCT00348283|144444883|SUPERIORITY_OR_OTHER|||||||0.001||||||The P value is from Cochran-Mantel-Haenszel test with clinical response (CR-70 responder status) at Week 4 as the stratification factor.|Cochran-Mantel-Haenszel|||The null hypothesis was that there is no difference in proportion of subjects with clinical remission at Week 52 in the two treatment groups.||||0.001
72461074|NCT00348283|144444884|SUPERIORITY_OR_OTHER|||||||0.15||||||The P value is from Cochran-Mantel-Haenszel test with clinical response (CR-70 responder status) at Week 4 as the stratification factor.|Cochran-Mantel-Haenszel|||The null hypothesis was that there is no difference between proportions of subjects without mucosal ulceration at both Week 12 and Week 52 in the two treatment groups.||||0.150
72461075|NCT00348283|144444885|SUPERIORITY_OR_OTHER||||||<|0.001||||||The P value is from Cochran-Mantel-Haenszel test with clinical response (CR-70 responder status) at Week 4 as the stratification factor.|Cochran-Mantel-Haenszel|||The null hypothesis was that there is no difference in proportion of subjects with clinical remission at Week 12 in the two treatment groups.||||<0.001
72461076|NCT06312566|144444917|EQUIVALENCE|Bioequivalence between the BRV tablet (reference) and BRV dry syrup (test) formulations were concluded if the 92.016% CI limits for Cmax,ss was within the 0.80 to 1.25 range.|Ratio of Dry Syrup/ Tablet|0.9726|||||TWO_SIDED|92.016|0.9257|1.022|||Linear mixed model analysis|||||1.022|0.9257|
72501368|NCT01440101|144532539|SUPERIORITY_OR_OTHER|||||||0.942||||||P-value for comparison between the treated and placebo groups was based on analysis of covariance, adjusted for the baseline VAS score.|ANCOVA|||Change from Baseline at Week 24||||0.942
72501369|NCT04898166|144532555|SUPERIORITY|||||||0|||||||Chi-squared|Chi-square value 18.90 and its asymptotic significance .000||||||0.000
72392733|NCT00730132|144292786|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|22.8181|STANDARD_DEVIATION|14.03545||||95.0||||||||Descriptive statistics of relative (%) change in TC from baseline at Visit 2||||
72461077|NCT06312566|144444918|EQUIVALENCE|Bioequivalence between the BRV tablet (reference) and BRV dry syrup (test) formulations were concluded if the 90% CI limits for AUC(tau) was within the 0.80 to 1.25 range.|Ratio of Dry Syrup/ Tablet|0.9999|||||TWO_SIDED|92.016|0.9881|1.012||||||||1.012|0.9881|
72461078|NCT04736472|144444925|SUPERIORITY|||||||0.224|||||||Fisher Exact|||Severe TRAEs||||.224
72461079|NCT04736472|144444925|SUPERIORITY|||||||0.025|||||||Fisher Exact|||Severe TRAEs||||.025
72461080|NCT02971683|144444943|SUPERIORITY||Odds Ratio (OR)|1.8||||0.083|TWO_SIDED|95.0|0.9|3.5|||Regression, Logistic|||||3.5|0.9|0.083
72461081|NCT04206501|144444957|SUPERIORITY|||||||0.064||||||The rate of change in HF medications (beta-blocker, diuretic, and Sacubitril/Valsartan) was compared betweenICM Guidedand usual care control group using chi-square analysis.|Chi-squared|||Due to the unexpected low enrollment during COVID pandemic, we aimed to primarily focus the limited analysis/description on the primary endpoint and exploratory analysis related to QOL||||0.064
72461082|NCT02268526|144444959|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.891|||||TWO_SIDED|90.0|0.606|1.305||||||||1.305|0.606|
72461083|NCT02268526|144444959|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.941|||||TWO_SIDED|90.0|0.639|1.377||||||||1.377|0.639|
72461084|NCT00763919|144444975|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Sign test|||The null hypothesis is that the median difference between 6 months and baseline equals zero.||||<.001
72501370|NCT04898166|144532556|SUPERIORITY|||||||0.081|||||||Chi-squared|Chi-square value 7.544 and its asymptotic significance .273||||||0.081
72501371|NCT00144170|144532578|SUPERIORITY_OR_OTHER||Risk Difference (RD)|18.5||||0.0001|TWO_SIDED|95.0|12.9|24.0|||Cochran-Mantel-Haenszel|Weighted by the size of enfuvirtide and protease inhibitor strata||||24.0|12.9|0.0001
72501372|NCT00144170|144532579|SUPERIORITY_OR_OTHER|||||||0.0001||95.0|||||Log Rank|||||||0.0001
72501373|NCT00144170|144532580|SUPERIORITY_OR_OTHER||Risk Difference (RD)|24.9||||0.0001|TWO_SIDED|95.0|18.6|31.1|||Cochran-Mantel-Haenszel|Weighted by the size of enfuvirtide and protease inhibitor strata||||31.1|18.6|0.0001
72621006|NCT03766906|144773096|SUPERIORITY||Mean Difference (Final Values)|0.07||||0.905|TWO_SIDED||||||t-test, 2 sided||Investigators tested whether pre-test to post-test change was significantly greater than 0 at P\<0.05.|The statistical analyses for the Student Self-Efficacy, in terms of type of statistical test, method, and the comments which we state within-subjects paired t-tests, are the same for each of the three subscales that make up Student Self-Efficacy (i.e., Relevance to schoolwork, Future aspirations, and Family support).||||.905
72621007|NCT03766906|144773097|SUPERIORITY||Mean Difference (Final Values)|0.36||||0.054|TWO_SIDED||||||t-test, 2 sided|Within subjects paired t-tests.|Investigators tested whether pre-test to post-test change was significantly greater than 0 at P\<0.05.|||||.054
72621008|NCT03766906|144773098|SUPERIORITY||Mean Difference (Final Values)|3.48|||<|0.001|TWO_SIDED||||||t-test, 2 sided|Within subjects paired t-tests.|Investigators tested whether pre-test to post-test change was significantly greater than 0 at P\<0.05.|||||<.001
72621009|NCT03766906|144773099|SUPERIORITY||Mean Difference (Final Values)|7.52|||<|0.001|TWO_SIDED||||||t-test, 2 sided|Within subjects paired t-tests.|Investigators tested whether pre-test to post-test change was significantly greater than 0 at P\<0.05.|||||<.001
72621010|NCT01651208|144773120|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.01|TWO_SIDED|95.0|||||Chi-squared|||We hypothesized that in the MINT group, at least 70% of subjects will reach an MPR of 0.80 while in the DVD group, the proportion will remain at or below 55%. Our sample size estimates showed that, using a conservative 2-sided test at the 5% Alpha level and a 90% power, we will be able to detect a significant 15% difference (70% - 55%) with a sample of 217 in each study group.||||<0.01
72621011|NCT01651208|144773121|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.29|||<|0.01|TWO_SIDED||||||t-test, 2 sided|||The null hypothesis is that the mean MMAS-4 score is similar in both intervention arms||||<0.01
72621012|NCT00836901|144773122|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of Least Squares Means|97.7||||||90.0|93.19|102.43|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||102.43|93.19|
72461085|NCT00763919|144444976|SUPERIORITY_OR_OTHER|||||||0.01||95.0|||||Sign test|||The null hypothesis is that the median difference between 6 months and baseline equals zero.||||.01
72461086|NCT00763919|144444977|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Sign test|||The null hypothesis is that the median difference between 6 months and baseline equals zero.||||<.001
72461087|NCT00763919|144444978|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Sign test|||The null hypothesis is that the median difference between 3 months and baseline equals zero.||||<.001
72461088|NCT00763919|144444979|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||The null hypothesis is that the mean difference between 3 months and baseline equals zero.||||<.001
72501374|NCT00144170|144532581|SUPERIORITY_OR_OTHER||Risk Difference (RD)|28.8||||0.0001|TWO_SIDED|95.0|22.5|35.1|||Cochran-Mantel-Haenszel|||||35.1|22.5|0.0001
72621013|NCT00836901|144773123|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of Least Squares Means|99.28||||||90.0|97.09|101.53|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||101.53|97.09|
72621014|NCT00836901|144773124|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of Least Squares Means|97.64||||||90.0|96.12|99.19|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||99.19|96.12|
72392734|NCT00730132|144292786|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.80928|STANDARD_ERROR_OF_MEAN|1.48621||0.143|TWO_SIDED|95.0|-6.307|0.6884|||Games-Howell|||Statin Dose Titration compared to New Statin||.6884|-6.3070|.143
72501375|NCT00144170|144532582|SUPERIORITY_OR_OTHER||Risk Difference (RD)|29.4||||0.0001|TWO_SIDED|95.0|23.2|35.7|||Cochran-Mantel-Haenszel|Weighted by the size of enfuvirtide and protease inhibitor strata||||35.7|23.2|0.0001
72501376|NCT00144170|144532583|SUPERIORITY_OR_OTHER||Risk Difference (RD)|26.6||||0.0001|TWO_SIDED|95.0|20.5|32.6|||Cochran-Mantel-Haenszel|Weighted by the size of enfuvirtide and protease inhibitor strata||||32.6|20.5|0.0001
72392735|NCT00730132|144292786|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.74811|STANDARD_ERROR_OF_MEAN|1.56351||0.001|TWO_SIDED|95.0|-9.4298|-2.0664|||Games-Howell|||Statin Dose Titration compared to Ezetimbe||-2.0664|-9.4298|.001
72461089|NCT00763919|144444980|SUPERIORITY_OR_OTHER|||||||0.042||95.0|||||t-test, 2 sided|||The null hypothesis is that the mean difference between 6 months and baseline equals zero.||||.042
72461090|NCT00763919|144444981|SUPERIORITY_OR_OTHER|||||||0.044||95.0|||||Sign test|||The null hypothesis is that the median difference between 6 months and baseline equals zero.||||.044
72461091|NCT00763919|144444982|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||t-test, 2 sided|||The null hypothesis is that the mean difference between 6 months and baseline equals zero.||||.002
72461092|NCT00763919|144444983|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||Sign test|||The null hypothesis is that the median difference between 6 months and baseline equals zero.||||.001
72461093|NCT00763919|144444984|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||t-test, 2 sided|||The null hypothesis is that the mean difference between 6 months and baseline equals zero.||||.001
72461094|NCT00763919|144444985|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||t-test, 2 sided|||The null hypothesis is that the mean difference between 6 months and baseline equals zero.||||.001
72461095|NCT00763919|144444986|SUPERIORITY_OR_OTHER|||||||0.827||95.0|||||t-test, 2 sided|||The null hypothesis is that the mean difference between 6 months and baseline equals zero.||||.827
72461096|NCT00763919|144444987|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||t-test, 2 sided|||The null hypothesis is that the mean difference between 6 months and baseline equals zero.||||.002
72461097|NCT00763919|144444988|SUPERIORITY_OR_OTHER|||||||0.246||95.0|||||t-test, 2 sided|||The null hypothesis is that the mean difference between 3 months and baseline equals zero.||||.246
72621015|NCT00836901|144773125|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of Least Squares Means|94.59||||||90.0|85.64|104.47|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||104.47|85.64|
72461098|NCT00763919|144444989|SUPERIORITY_OR_OTHER|||||||0.101||95.0|||||Sign test|||The null hypothesis is that the median difference between 3 months and baseline equals zero.||||.101
72461099|NCT00763919|144444990|SUPERIORITY_OR_OTHER|||||||0.003||95.0|||||Sign test|||The null hypothesis is that the median difference between 3 months and baseline equals zero.||||.003
72461100|NCT00763919|144444991|SUPERIORITY_OR_OTHER|||||||0.096||95.0|||||t-test, 2 sided|||The null hypothesis is that the mean difference between 3 months and baseline equals zero.||||.096
72461101|NCT00763919|144444992|SUPERIORITY_OR_OTHER|||||||0.072||95.0|||||Sign test|||The null hypothesis is that the median difference between 3 months and baseline equals zero.||||.072
72461102|NCT00763919|144444993|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 1 sided|||The null hypothesis is that the mean difference between 3 months and baseline equals zero.||||<.001
72461103|NCT00763919|144444994|SUPERIORITY_OR_OTHER|||||||0.078||95.0|||||t-test, 2 sided|||The null hypothesis is that the mean difference between 3 months and baseline equals zero.||||.078
72461104|NCT00763919|144444995|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||Sign test|||The null hypothesis is that the median difference between 3 months and baseline equals zero.||||.002
72461105|NCT00763919|144444996|SUPERIORITY_OR_OTHER|||||||0.562||95.0|||||t-test, 2 sided|||The null hypothesis is that the mean difference between 3 months and baseline equals zero.||||.562
72461106|NCT00763919|144444997|SUPERIORITY_OR_OTHER|||||||0.12||95.0|||||t-test, 2 sided|||The null hypothesis is that the mean difference between 3 months and baseline equals zero.||||.12
72461107|NCT03305458|144445004|SUPERIORITY||||||||||||||||||To determine if child and caregiver engagement is affected by overall SPARK use, a 2-level MLM (level-1 child, level-2 provider) will be used. Engagement scores will be calculated per child and caregiver participant. An aggregate engagement score will determine if there are differences across conditions (SPARK + TF CBT vs standard TF-CBT) while accounting for the nesting providers.|||
72461108|NCT03305458|144445005|SUPERIORITY||||||||||||||||||To determine if provider fidelity is affected by overall SPARK use, a 2-level MLM (level-1 child; level-2 provider) will be used. Fidelity will be measured by the TF-CBT TPOCS-S. Providers' overall use of the toolkit will be calculated per child participant and averaged across toolkit content. Fidelity scores will be calculated per child participant such that each provider will have three ratings. An aggregate fidelity score will determine if there are differences across conditions (SPARK + TF-CBT vs. standard TF-CBT) while accounting for the nesting of providers.|||
72461109|NCT03305458|144445006|SUPERIORITY||||||||||||||||||Response to the intervention will be evaluated with a piecewise longitudinal MLM that contains an additional level corresponding to time. Level-1 will correspond to time, level-2 to child, and level-to provider.|||
72461110|NCT03305458|144445007|SUPERIORITY||||||||||||||||||Response to the intervention will be evaluated with a piecewise longitudinal MLM that contains an additional level corresponding to time. Level-1 will correspond to time, level-2 to child, and level-3 to provider|||
72501377|NCT00144170|144532584|SUPERIORITY_OR_OTHER||Risk Difference (RD)|22.1||||0.0001|TWO_SIDED|95.0|16.2|27.9|||Cochran-Mantel-Haenszel|Weighted by the size of enfuvirtide and protease inhibitor strata||||27.9|16.2|0.0001
72461111|NCT03305458|144445008|SUPERIORITY||||||||||||||||||Response to the intervention will be evaluated with a piecewise longitudinal MLM that contains an additional level corresponding to time. Level-1 will correspond to time, level-2 to child, and level-3 to provider|||
72461112|NCT03305458|144445009|SUPERIORITY||||||||||||||||||Response to the intervention will be evaluated with a piecewise longitudinal MLM that contains an additional level corresponding to time. Level-1 will correspond to time, level-2 to child, and level-3 to provider|||
72461113|NCT03305458|144445010|SUPERIORITY||||||||||||||||||Response to the intervention will be evaluated with a piecewise longitudinal MLM that contains an additional level corresponding to time. Level-1 will correspond to time, level-2 to child, and level-3 to provider|||
72461114|NCT03305458|144445011|SUPERIORITY||||||||||||||||||Response to the intervention will be evaluated with a piecewise longitudinal MLM that contains an additional level corresponding to time. Level-1 will correspond to time, level-2 to child, and level-3 to provider|||
72461115|NCT03305458|144445012|SUPERIORITY||||||||||||||||||Response to the intervention will be evaluated with a piecewise longitudinal MLM that contains an additional level corresponding to time. Level-1 will correspond to time, level-2 to child, and level-3 to provider.|||
72461116|NCT03305458|144445013|SUPERIORITY||||||||||||||||||Response to the intervention will be evaluated with a piecewise longitudinal MLM that contains an additional level corresponding to time. Level-1 will correspond to time, level-2 to child, and level-3 to provider.|||
72461117|NCT03305458|144445014|SUPERIORITY||||||||||||||||||Response to the intervention will be evaluated with a piecewise longitudinal MLM that contains an additional level corresponding to time. Level-1 will correspond to time, level-2 to child, and level-3 to provider.|||
72461118|NCT03305458|144445015|SUPERIORITY||||||||||||||||||Response to the intervention will be evaluated with a piecewise longitudinal MLM that contains an additional level corresponding to time. Level-1 will correspond to time, level-2 to child, and level-3 to provider|||
72461119|NCT03305458|144445016|SUPERIORITY||||||||||||||||||Response to the intervention will be evaluated with a piecewise longitudinal MLM that contains an additional level corresponding to time. Level-1 will correspond to time, level-2 to child, and level-3 to provider|||
72461120|NCT03305458|144445017|SUPERIORITY||||||||||||||||||Response to the intervention will be evaluated with a piecewise longitudinal MLM that contains an additional level corresponding to time. Level-1 will correspond to time, level-2 to child, and level-3 to provider|||
72461121|NCT03305458|144445018|SUPERIORITY||||||||||||||||||Response to the intervention will be evaluated with a piecewise longitudinal MLM that contains an additional level corresponding to time. Level-1 will correspond to time, level-2 to child, and level-3 to provider|||
72461122|NCT03305458|144445019|SUPERIORITY||||||||||||||||||response to the intervention will be evaluated with a piecewise longitudinal MLM that contains an additional level corresponding to time. Level-1 will correspond to time, level-2 to child, and level-3 to provider.|||
72461123|NCT03305458|144445020|SUPERIORITY||||||||||||||||||Response to the intervention will be evaluated with a piecewise longitudinal MLM that contains an additional level corresponding to time. Level-1 will correspond to time, level-2 to child, and level-3 to provider|||
72461124|NCT03305458|144445021|SUPERIORITY||||||||||||||||||Response to the intervention will be evaluated with a piecewise longitudinal MLM that contains an additional level corresponding to time. Level-1 will correspond to time, level-2 to child, and level-3 to provider|||
72461125|NCT03305458|144445022|SUPERIORITY||||||||||||||||||Response to the intervention will be evaluated with a piecewise longitudinal MLM that contains an additional level corresponding to time. Level-1 will correspond to time, level-2 to child, and level-3 to provider|||
72461126|NCT03305458|144445023|SUPERIORITY||||||||||||||||||Response to the intervention will be evaluated with a piecewise longitudinal MLM that contains an additional level corresponding to time. Level-1 will correspond to time, level-2 to child, and level-3 to provider|||
72461127|NCT03305458|144445024|SUPERIORITY||||||||||||||||||Response to the intervention will be evaluated with a piecewise longitudinal MLM that contains an additional level corresponding to time. Level-1 will correspond to time, level-2 to child, and level-3 to provider|||
72461128|NCT05431543|144445025|SUPERIORITY||Odds Ratio (OR)|83.988|||<|0.0001|TWO_SIDED||||||Generalized Estimating Equation (GEE)|||||||<0.0001
72461129|NCT05431543|144445025|SUPERIORITY||Odds Ratio (OR)|102.093|||<|0.0001|TWO_SIDED||||||Generalized Estimating Equation (GEE)|||||||<0.0001
72461130|NCT01636778|144445043|SUPERIORITY_OR_OTHER||Percentage|88.0|||||TWO_SIDED|95.0|74.0|96.0||||||||96|74|
72461131|NCT01154699|144445104|SUPERIORITY_OR_OTHER|||||||0.8|||||||t-test, 2 sided|||The difference in the change in asthma control during the Usual care and the Bilevel PAP period were compared.||||0.8
72461132|NCT01154699|144445105|SUPERIORITY_OR_OTHER|||||||0.2|||||||t-test, 2 sided|||Change in PC20 between the two arms||||0.20
72461133|NCT01154699|144445106|SUPERIORITY_OR_OTHER|||||||0.78|||||||t-test, 2 sided|||||||0.78
72501378|NCT00144170|144532585|SUPERIORITY_OR_OTHER||Risk Difference (RD)|19.0||||0.0001|TWO_SIDED|95.0|13.3|24.7||Weighted by the size of enfuvirtide and protease inhibitor strata|Cochran-Mantel-Haenszel|||||24.7|13.3|0.0001
72501379|NCT00144170|144532586|SUPERIORITY_OR_OTHER||Risk Difference (RD)|18.7||||0.0001|TWO_SIDED|95.0|13.0|24.4||Weighted by the size of enfuvirtide and protease inhibitor strata|Cochran-Mantel-Haenszel|||||24.4|13.0|0.0001
72501380|NCT00144170|144532587|SUPERIORITY_OR_OTHER||Risk Difference (RD)|17.2||||0.0001|TWO_SIDED|95.0|11.7|22.7||Weighted by the size of enfuvirtide and protease inhibitor strata|Cochran-Mantel-Haenszel|||||22.7|11.7|0.0001
72461134|NCT01154699|144445107|SUPERIORITY_OR_OTHER|||||||0.61|||||||t-test, 2 sided|||||||0.61
72461135|NCT01154699|144445108|SUPERIORITY_OR_OTHER|||||||0.94|||||||t-test, 2 sided|||||||0.94
72461136|NCT01154699|144445109|SUPERIORITY_OR_OTHER|||||||0.76|||||||t-test, 2 sided|||||||0.76
72501381|NCT00144170|144532588|SUPERIORITY_OR_OTHER||Risk Difference (RD)|17.1||||0.0001|TWO_SIDED|95.0|11.7|22.4||Weighted by the size of enfuvirtide and protease inhibitor strata|Cochran-Mantel-Haenszel|||||22.4|11.7|0.0001
72501382|NCT00144170|144532589|SUPERIORITY_OR_OTHER||Risk Difference (RD)|17.3||||0.0001|TWO_SIDED|95.0|12.0|22.5||Weighted by the size of enfuvirtide and protease inhibitor strata|Cochran-Mantel-Haenszel|||||22.5|12.0|0.0001
72501383|NCT00144170|144532590|SUPERIORITY_OR_OTHER||Risk Difference (RD)|16.4||||0.0001|TWO_SIDED|95.0|11.2|21.5||Weighted by the size of enfuvirtide and protease inhibitor strata|Cochran-Mantel-Haenszel|||||21.5|11.2|0.0001
72461137|NCT01044901|144445124|OTHER|||||||0.0039||||||P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05.|t-test, 2 sided|||Primary outcome was presented at baseline as mean +/- standard deviation based upon the Shapiro-Wilks test of normality, and then analyzed with a Student t-test.||||0.0039
72461138|NCT01044901|144445125|OTHER||||||<|0.0001||||||P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05.|Wilcoxon (Mann-Whitney)|||Primary outcome was presented at baseline as median (interquartile range) based upon the Shapiro-Wilks test of normality, and then analyzed with a Wilcoxon (Mann-Whitney test).||||<0.0001
72461139|NCT01044901|144445126|OTHER|||||||0.0137|||||||t-test, 2 sided|P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05.||Primary outcome was presented at baseline as mean +/- standard deviation based upon the Shapiro-Wilks test of normality, and then analyzed with a Student t-test.||||0.0137
72461140|NCT01044901|144445127|OTHER|||||||0.0039||||||P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05.|t-test, 2 sided|||Primary outcome was presented at baseline as mean +/- standard deviation based upon the Shapiro-Wilks test of normality, and then analyzed with a Student t-test.||||0.0039
72501384|NCT00144170|144532591|SUPERIORITY_OR_OTHER||Risk Difference (RD)|16.2||||0.0001|TWO_SIDED|95.0|11.1|21.3||Weighted by the size of enfuvirtide and protease inhibitor strata|Cochran-Mantel-Haenszel|||||21.3|11.1|0.0001
72501385|NCT00144170|144532592|SUPERIORITY_OR_OTHER||Risk Difference (RD)|15.6||||0.0001|TWO_SIDED|95.0|10.6|20.6||Weighted by the size of enfuvirtide and protease inhibitor strata|Cochran-Mantel-Haenszel|||||20.6|10.6|0.0001
72501386|NCT00144170|144532593|SUPERIORITY_OR_OTHER|||||||0.0001||95.0|||||Log Rank|||||||0.0001
72501387|NCT00144170|144532594|SUPERIORITY_OR_OTHER|||||||0.0001||95.0|||||Log Rank|||||||0.0001
72501388|NCT00144170|144532595|SUPERIORITY_OR_OTHER|||||||0.0001||95.0|||||Log Rank|||||||0.0001
72501389|NCT00144170|144532669|SUPERIORITY_OR_OTHER|||||||0.1026||95.0|||||Log Rank|||||||0.1026
72501390|NCT00045032|144532693|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Log Rank|||||||<0.0001
72501391|NCT00045032|144532693|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.54|||||TWO_SIDED|95.0|0.44|0.67|||||HR for Herceptin 1-Year Arm versus Observation Arm.|||0.67|0.44|
72461141|NCT01044901|144445128|OTHER|||||||0.16||||||P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05.|t-test, 2 sided|||Primary outcome was presented at baseline as mean +/- standard deviation based upon the Shapiro-Wilks test of normality, and then analyzed with a Student t-test.||||0.16
72461142|NCT01044901|144445129|OTHER|||||||0.0039||||||P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05.|t-test, 2 sided|||Primary outcome was presented at baseline as mean +/- standard deviation based upon the Shapiro-Wilks test of normality, and then analyzed with a Student t-test.||||0.0039
72461143|NCT01044901|144445130|OTHER|||||||0.0011||||||P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05.|Wilcoxon (Mann-Whitney)|||Primary outcome was presented at baseline as median (interquartile range) based upon the Shapiro-Wilks test of normality, and then analyzed with a Wilcoxon (Mann-Whitney) test.||||0.0011
72461144|NCT01044901|144445131|OTHER|||||||0.1||||||P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05.|Wilcoxon (Mann-Whitney)|||Primary outcome was presented at baseline as median (interquartile range) based upon the Shapiro-Wilks test of normality, and then analyzed with a Wilcoxon (Mann-Whitney) test.||||0.10
72461145|NCT01044901|144445132|OTHER|||||||0.48||||||P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05.|t-test, 2 sided|||Primary outcome was presented at baseline as mean +/- standard deviation based upon the Shapiro-Wilks test of normality, and then analyzed with a Student t-test.||||0.48
72461146|NCT01044901|144445133|OTHER|||||||0.08||||||P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05.|Fisher Exact|||Primary outcome was presented as frequencies and percentages, and then analyzed with a Fisher exact test.||||0.08
72461147|NCT01044901|144445134|OTHER|||||||0.91||||||P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05.|t-test, 2 sided|||Primary outcome was presented at baseline as mean +/- standard deviation based upon the Shapiro-Wilks test of normality, and then analyzed with a Student t-test.||||0.91
72461148|NCT01044901|144445135|OTHER|||||||0.0038||||||P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05.|Wilcoxon (Mann-Whitney)|||Primary outcome was presented at baseline as median (interquartile range) based upon the Shapiro-Wilks test of normality, and then analyzed with a Wilcoxon (Mann-Whitney) test.||||0.0038
72461149|NCT01044901|144445136|OTHER|||||||0.034||||||P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05.|t-test, 2 sided|||Primary outcome was presented at baseline as mean +/- standard deviation based upon the Shapiro-Wilks test of normality, and then analyzed with a Student t-test.||||0.034
72461150|NCT01044901|144445137|OTHER|||||||0.25||||||P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05.|Fisher Exact|||Primary outcome was presented was as frequencies and percentages, and then analyzed with a Fisher exact test.||||0.25
72461151|NCT01044901|144445138|OTHER|||||||0.0288||||||P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05.|Wilcoxon (Mann-Whitney)|||Primary outcome was presented at baseline as median (interquartile range) based upon the Shapiro-Wilks test of normality, and then analyzed with a Wilcoxon (Mann-Whitney) test.||||0.0288
72461152|NCT01044901|144445139|OTHER|||||||0.14||||||P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05.|Wilcoxon (Mann-Whitney)|||Primary outcome was presented at baseline as median (interquartile range) based upon the Shapiro-Wilks test of normality, and then analyzed with a Wilcoxon (Mann-Whitney) test.||||0.14
72461153|NCT01044901|144445140|OTHER|||||||0.13||||||P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05.|t-test, 2 sided|||Primary outcome was presented at baseline as mean +/- standard deviation based upon the Shapiro-Wilks test of normality, and then analyzed with a Student t-test.||||0.13
72501392|NCT00045032|144532694|SUPERIORITY_OR_OTHER|||||||0|||||||Log Rank|||||||0.000
72461154|NCT01044901|144445141|OTHER|||||||0.81||||||P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05.|t-test, 2 sided|||Primary outcome was presented at baseline as mean +/- standard deviation based upon the Shapiro-Wilks test of normality, and then analyzed with a Student t-test.||||0.81
72461155|NCT01044901|144445142|OTHER|||||||0.3||||||P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05.|t-test, 2 sided|||Primary outcome was presented at baseline as mean +/- standard deviation based upon the Shapiro-Wilks test of normality, and then analyzed with a Student t-test.||||0.30
72461156|NCT04050722|144445149|SUPERIORITY||Adjusted Mean Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.01|<|0.0001|TWO_SIDED|95.0|-0.08|-0.04||Analysis was performed using ANCOVA model with study product group, gender, and baseline MGI stratification (low/high) as factors and the baseline value as covariate.|ANCOVA|||||-0.04|-0.08|<0.0001
72461157|NCT03451292|144445156|SUPERIORITY||Hazard Ratio (HR)|0.8||||0.17|TWO_SIDED|95.0|0.58|1.1|||Cox Proportional- Hazards (PH) model|||Stratification factors included were the region (Europe or North America) and history of hospitalization for acute decompensation of liver cirrhosis (yes or no).||1.10|0.58|0.17
72501393|NCT00045032|144532694|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.43|||||TWO_SIDED|95.0|0.34|0.53|||||HR for Herceptin 2-Year Arm versus Observation Arm.|||0.53|0.34|
72501394|NCT00045032|144532697|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Log Rank|||||||<0.0001
72621016|NCT00836901|144773126|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of Least Squares Means|94.44||||||90.0|87.83|101.54|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||101.54|87.83|
72621017|NCT00836901|144773127|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of Least Squares Means|94.08||||||90.0|87.19|101.52|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||101.52|87.19|
72621018|NCT02732145|144773166|OTHER|"Question: Determination of sensitivity of the Vulvoscopy Index as a measure of the sensitivity of Three Rings Vulvoscopy in comparison to the histopathological diagnosis of vulvar dermatosis."|Sensitivity (2x2 Table)|1.0|||||TWO_SIDED|95.0|1.0|1.0|||||"The Sensitivity of the Vulvoscopy Index for Detection of Vulvar Dermatosis was 1.000 (Range: 1.0000 - 1.0000)."|"Parameter: Sensitivity of Three Rings Vulvoscopy for detection of vulvar dermatosis."||1.0000|1.0000|
72621019|NCT02732145|144773166|OTHER|"Question: Determination of specificity of the Vulvoscopy index as a measure of the specificity of Three Rings Vulvoscopy in comparison to the histopathological diagnosis of vulvar dermatosis."|Specificity (2x2 Table)|0.9609|||||TWO_SIDED|95.0|0.5794|1.0|||||"The Specificity of the Vulvoscopy Index for Detection of Vulvar Dermatosis was 0.9609 (Range: 0.5794 - 1.0000)"|"Parameter: Specificity of Three Rings Vulvoscopy for detection of vulvar dermatosis."||1.0000|0.5794|
72621020|NCT02732145|144773166|OTHER|"Question: Determination of diagnostic accuracy of the Vulvoscopy index as a measure of the diagnostic value of Three Rings Vulvoscopy in comparison to the histopathological diagnosis of vulvar dermatosis."|Diagnostic Accuracy (2x2 Table)|0.9695|||||TWO_SIDED|95.0|0.6313|1.0|||||"The Diagnostic accuracy of the Vulvoscopy Index for Detection of Vulvar Dermatosis was 0.9695 (Range: 0.6313 - 1.0000)"|"Parameter: Diagnostic accuracy of Three Rings Vulvoscopy for detection of vulvar dermatosis."||1.0000|0.6313|
72621021|NCT02732145|144773166|SUPERIORITY|"Question: Determination of positive predictive value of the Vulvoscopy index for detection of vulvar dermatosis in comparison to the histopathology results."|PPV (2x2 Table)|0.878|||||TWO_SIDED|95.0|0.227|1.0|||||"Positive predictive value of the Vulvoscopy Index for Detection of Vulvar Dermatosis was 0.8780 (Range: 0.2270 - 1.0000)."|"Parameter: Positive predictive value of Three Rings Vulvoscopy for detection of vulvar dermatosis."||1.0000|0.2270|
72621022|NCT02732145|144773166|OTHER|"Question: Determination of negative predictive value of the Vulvoscopy index for detection of vulvar dermatosis in comparison to the histopathology results."|NPV (2x2 Table)|1.0|||||TWO_SIDED|95.0|1.0|1.0|||||"Negative predictive value of the Vulvoscopy Index for Detection of Vulvar Dermatosis was 1.0000 (Range: 1.0000 - 1.0000)."|"Parameter: Negative predictive value of Three Rings Vulvoscopy for detection of vulvar dermatosis."||1.0000|1.0000|
72392736|NCT00730132|144292786|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.93883|STANDARD_ERROR_OF_MEAN|1.38286||0.086|TWO_SIDED|95.0|-6.1948|0.3171|||Games-Howell|||New Statin compared to Ezetimibe||.3171|-6.1948|.086
72461158|NCT05129592|144445170|SUPERIORITY||Mean Difference (Final Values)|15.71|STANDARD_ERROR_OF_MEAN|7.3||0.095|TWO_SIDED|95.0|-1.87|33.3||Sidak's adjusted p-value contrasting marginal linear predictions for the Nicotine corrective control and Nicotine corrective with both components of coherence|ANCOVA|Controlling for baseline nicotine misperception (df=4)|Comparing Nicotine corrective control to the Nicotine corrective with both components of coherence|||33.30|-1.87|0.095
72461159|NCT05129592|144445170|SUPERIORITY||Mean Difference (Final Values)|18.67|STANDARD_ERROR_OF_MEAN|7.3||0.022|TWO_SIDED|95.0|2.02|35.33||Sidak's adjustment for multiple comparisons|ANCOVA|Controlling for baseline nicotine misperception (df=4)|Comparing Nicotine corrective control to the Nicotine corrective with both components of coherence|Sidak's adjusted p-value contrasting marginal linear predictions for the Nicotine corrective with causal explanation and Nicotine corrective with both components of coherence||35.33|2.02|0.022
72501395|NCT00045032|144532697|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.76|||||TWO_SIDED|95.0|0.67|0.86|||||HR for Herceptin 1-Year Arm versus Observation Arm.|||0.86|0.67|
72501396|NCT00045032|144532697|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Log Rank|||||||<0.0001
72501397|NCT00045032|144532697|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.75|||||TWO_SIDED|95.0|0.67|0.85|||||HR for Herceptin 2-Year Arm versus Observation Arm.|||0.85|0.67|
72501398|NCT00045032|144532702|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.76|||||TWO_SIDED|95.0|0.68|0.86|||||HR for Herceptin 1-Year Arm versus Observation Arm.|||0.86|0.68|
72501399|NCT00045032|144532702|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.77|||||TWO_SIDED|95.0|0.69|0.87|||||HR for Herceptin 2-Year Arm versus Observation Arm.|||0.87|0.69|
72501400|NCT00045032|144532709|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.02||||0.7962|TWO_SIDED|95.0|0.89|1.17|||Log Rank||HR for Herceptin 2-Year Arm versus Herceptin 1-Year Arm.|||1.17|0.89|0.7962
72501401|NCT00045032|144532711|SUPERIORITY_OR_OTHER|||||||0.2379|||||||Log Rank|||||||0.2379
72501402|NCT00045032|144532711|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.75|||||TWO_SIDED|95.0|0.47|1.21|||||HR for Herceptin 1-Year Arm versus Observation Arm.|||1.21|0.47|
72501403|NCT00045032|144532712|SUPERIORITY_OR_OTHER|||||||0.003|||||||Log Rank|||||||0.003
72392737|NCT00730132|144292787|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|26.8174|STANDARD_DEVIATION|19.85205||||95.0||||||||Descriptive statistics of relative (%) change in LDL-C levels by the end of the study (Visit 2) compared to Baseline (Visit 1)||||
72501404|NCT00045032|144532712|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.47|||||TWO_SIDED|95.0|0.28|0.79|||||HR for Herceptin 2-Year Arm versus Observation Arm.|||0.79|0.28|
72501405|NCT00045032|144532715|SUPERIORITY_OR_OTHER|||||||0.0005|||||||Log Rank|||||||0.0005
72501406|NCT00045032|144532715|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.76|||||TWO_SIDED|95.0|0.65|0.88|||||HR for Herceptin 1-Year Arm versus Observation Arm.|||0.88|0.65|
72501407|NCT00045032|144532715|SUPERIORITY_OR_OTHER|||||||0.0001|||||||Log Rank|||||||0.0001
72501408|NCT00045032|144532715|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.74|||||TWO_SIDED|95.0|0.63|0.86|||||HR for Herceptin 2-Year Arm versus Observation Arm.|||0.86|0.63|
72501409|NCT00045032|144532717|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.74|||||TWO_SIDED|95.0|0.64|0.86|||||HR for Herceptin 1-Year Arm versus Observation Arm.|||0.86|0.64|
72501410|NCT00045032|144532717|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.72|||||TWO_SIDED|95.0|0.62|0.83|||||HR for Herceptin 2-Year Arm versus Observation Arm.|||0.83|0.62|
72501411|NCT00045032|144532719|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.01||||0.9156|TWO_SIDED|95.0|0.84|1.21|||Log Rank||HR for Herceptin 2-Year Arm versus Herceptin 1-Year Arm.|||1.21|0.84|0.9156
72501412|NCT00045032|144532721|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Log Rank|||||||<0.0001
72501413|NCT00045032|144532721|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.73|||||TWO_SIDED|95.0|0.64|0.83|||||HR for Herceptin 1-Year Arm versus Observation Arm.|||0.83|0.64|
72501414|NCT00045032|144532721|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Log Rank|||||||<0.0001
72501415|NCT00045032|144532721|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.69|||||TWO_SIDED|95.0|0.61|0.79|||||HR for Herceptin 2-Year Arm versus Observation Arm.|||0.79|0.61|
72501416|NCT00045032|144532723|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.94||||0.4755|TWO_SIDED|95.0|0.8|1.11|||Log Rank||HR for Herceptin 2-Year Arm versus Herceptin 1-Year Arm.|||1.11|0.80|0.4755
72563480|NCT02413294|144658216|SUPERIORITY|||||||0.37||||||This t-test analyzes the change in mean between the midpoint interview immediately prior to the start of the intervention and the follow-up interview at the conclusion of the intervention.|Paired T test, 2-sided|||The analysis, like the measures themselves, tracks the significance of the change from end of pre-intervention period to end of intervention period, so while only a single comparison group is listed, because it is all one population group, there are two sets of data for that group.||||0.37
72501417|NCT00045032|144532725|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Log Rank|||||||<0.0001
72501418|NCT00045032|144532725|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.76|||||TWO_SIDED|95.0|0.67|0.87|||||HR for Herceptin 1-Year Arm versus Observation Arm.|||0.87|0.67|
72501419|NCT00045032|144532725|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Log Rank|||||||<0.0001
72501420|NCT00045032|144532725|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.75|||||TWO_SIDED|95.0|0.65|0.85|||||HR for Herceptin 2-Year Arm versus Observation Arm.|||0.85|0.65|
72501421|NCT00045032|144532727|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.0||||0.9626|TWO_SIDED|95.0|0.85|1.17|||Log Rank||HR for Herceptin 2-Year Arm versus Herceptin 1-Year Arm.|||1.17|0.85|0.9626
72501422|NCT00045032|144532729|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Log Rank|||||||<0.0001
72501423|NCT00045032|144532729|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.73|||||TWO_SIDED|95.0|0.64|0.83|||||HR for Herceptin 1-Year Arm versus Observation Arm.|||0.83|0.64|
72501424|NCT00045032|144532729|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Log Rank|||||||<0.0001
72501425|NCT00045032|144532729|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.69|||||TWO_SIDED|95.0|0.61|0.79|||||HR for Herceptin 2-Year Arm versus Observation Arm.|||0.79|0.61|
72501426|NCT00045032|144532731|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.94||||0.45|TWO_SIDED|95.0|0.8|1.1|||Log Rank||HR for Herceptin 2-Year Arm versus Herceptin 1-Year Arm.|||1.10|0.80|0.4500
72501427|NCT00045032|144532733|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Log Rank|||||||<0.0001
72501428|NCT00045032|144532733|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.72|||||TWO_SIDED|95.0|0.62|0.83|||||HR for Herceptin 1-Year Arm versus Observation Arm.|||0.83|0.62|
72501429|NCT00045032|144532733|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Log Rank|||||||<0.0001
72501430|NCT00045032|144532733|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.69|||||TWO_SIDED|95.0|0.59|0.79|||||HR for Herceptin 2-Year Arm versus Observation Arm.|||0.79|0.59|
72501431|NCT00045032|144532735|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.96||||0.6823|TWO_SIDED|95.0|0.8|1.15|||Log Rank||HR for Herceptin 2-Year Arm versus Herceptin 1-Year Arm.|||1.15|0.80|0.6823
72501432|NCT00045032|144532737|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.97||||0.7251|TWO_SIDED|95.0|0.84|1.13|||Log Rank||HR for Herceptin 2-Year Arm versus Herceptin 1-Year Arm.|||1.13|0.84|0.7251
72501433|NCT05818124|144532765|OTHER||Difference in Least Squares Mean|-0.48||||0.783|TWO_SIDED|95.0|-3.97|3.0|||ANOVA|||||3.00|-3.97|0.783
72501434|NCT05818124|144532766|OTHER||Difference in Least Squares Mean|-2.21||||0.032|TWO_SIDED|95.0|-4.21|-0.21|||ANOVA|||||-0.21|-4.21|0.032
72501435|NCT05818124|144532767|OTHER||Difference in Least Squares Mean|0.2||||0.756|TWO_SIDED|95.0|-1.07|1.47|||ANOVA|||||1.47|-1.07|0.756
72501436|NCT05818124|144532768|OTHER|Clopper and Pearson exact binomial method|Difference in Percentage|0.0|||||TWO_SIDED|95.0|-23.21|23.21||||||||23.21|-23.21|
72501437|NCT05818124|144532769|OTHER|Clopper and Pearson binomial method|Difference in percentage|-2.86|||||TWO_SIDED|95.0|-25.78|20.27||||||||20.27|-25.78|
72501438|NCT05818124|144532770|OTHER|Clopper and Pearson exact binomial method|Difference in Percentage|-8.57|||||TWO_SIDED|95.0|-30.26|13.38||||||||13.38|-30.26|
72501439|NCT05818124|144532771|OTHER|Clopper and Pearson binomial method|Difference in percentage|-5.71|||||TWO_SIDED|95.0|-25.18|13.97||||||||13.97|-25.18|
72501440|NCT05818124|144532772|OTHER|Clopper and Pearson binomial method|Difference in percentage|-5.71|||||TWO_SIDED|95.0|-25.18|13.97||||||||13.97|-25.18|
72501441|NCT05818124|144532773|OTHER|Clopper and Pearson binomial method|Difference in percentage|-8.57|||||TWO_SIDED|95.0|-27.63|10.5||||||||10.50|-27.63|
72501442|NCT05818124|144532776|OTHER||Hazard Ratio (HR)|0.82||||0.3102|TWO_SIDED|95.0|0.51|1.33|||Log Rank||Based on Cox regression model with Efron's method of tie handling with treatment as a covariate|||1.33|0.51|0.3102
72501443|NCT05818124|144532777|OTHER||Hazard Ratio (HR)|0.55||||0.0779|TWO_SIDED|95.0|0.27|1.14|||Log Rank||Based on Cox regression model with Efron's method of tie handling with treatment as a covariate|||1.14|0.27|0.0779
72392738|NCT00730132|144292787|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|28.2488|STANDARD_DEVIATION|20.78727||||95.0||||||||Descriptive statistics of relative (%) change in LDL-C levels by the end of the study (Visit 2) compared to Baseline (Visit 1)||||
72392739|NCT00730132|144292787|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|32.0665|STANDARD_DEVIATION|15.5901||||95.0||||||||Descriptive statistics of relative (%) change in LDL-C levels by the end of the study (Visit 2) compared to Baseline (Visit 1)||||
72392740|NCT00730132|144292787|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.43138|STANDARD_ERROR_OF_MEAN|2.01009||0.756|TWO_SIDED|95.0|-6.1604|3.2977|||Games-Howell|||Statin Dose Titration compared to New Statin||3.2977|-6.1604|.756
72392741|NCT00730132|144292787|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.24911|STANDARD_ERROR_OF_MEAN|1.97821||0.023|TWO_SIDED|95.0|-9.9072|-0.591|||Games-Howell|||Statin Dose Titration compared to Ezetimibe||-.5910|-9.9072|.023
72461160|NCT05129592|144445170|SUPERIORITY||Mean Difference (Final Values)|3.69|STANDARD_ERROR_OF_MEAN|7.3||0.931|TWO_SIDED|95.0|-12.76|20.15||Sidak's adjustment for multiple comparisons|ANCOVA|Controlling for baseline nicotine misperception (df=4)|Comparing Nicotine corrective with reason for misperception to the Nicotine corrective with both components of coherence|Sidak's adjusted p-value contrasting marginal linear predictions for the Nicotine corrective with reason for misperception and Nicotine corrective with both components of coherence||20.15|-12.76|0.931
72461161|NCT05129592|144445171|SUPERIORITY||Odds Ratio (OR)|1.54||||0.402|TWO_SIDED|95.0|0.56|4.24|||Regression, Logistic||Odds of believing e-cigarettes are less harmful than cigarettes in the Nicotine corrective with causal explanation/odds of believing e-cigarettes are less harmful than cigarettes in the condition with both component of coherence|Unadjusted logistic regression showing the effect of condition (Nicotine corrective with causal explanation compared to the Nicotine corrective with both components of coherence (reference group)) on e-cigarette relative harm beliefs||4.24|0.56|0.402
72461162|NCT05129592|144445171|SUPERIORITY||Odds Ratio (OR)|1.83||||0.292|TWO_SIDED|95.0|0.59|5.62|||Regression, Logistic||Odds of believing e-cigarettes are somewhat or much less harmful than cigarettes in the control condition/odds of believing e-cigarettes are somewhat or much less harmful than cigarettes in the condition with both component of coherence|Unadjusted logistic regression showing the effect of condition (Nicotine corrective control compared to the Nicotine corrective with both components of coherence (reference group)) on e-cigarette relative harm beliefs||5.62|0.59|0.292
72461163|NCT05129592|144445171|SUPERIORITY||Odds Ratio (OR)|0.77||||0.571|TWO_SIDED|95.0|0.3|1.93|||Regression, Logistic||Odds of believing e-cigarettes are less harmful than cigarettes in the Nicotine corrective with reason for misperception/odds of believing e-cigarettes are less harmful than cigarettes in the condition with both component of coherence|Unadjusted logistic regression showing the effect of condition (Nicotine corrective with reason for misperception compared to the Nicotine corrective with both components of coherence (reference group)) on e-cigarette relative harm beliefs||1.93|0.30|0.571
72461164|NCT05129592|144445171|SUPERIORITY||Odds Ratio (OR)|1.98|STANDARD_ERROR_OF_MEAN|1.44||0.349|TWO_SIDED|95.0|0.47|8.26|||Regression, Logistic||Odds of believing e-cigarettes are less harmful than cigarettes in the control condition/odds of believing e-cigarettes are less harmful than cigarettes in the condition with both component of coherence|Adjusted logistic regression showing the effect of condition (Nicotine corrective control compared to the Nicotine corrective with both components of coherence (reference group)) on e-cigarette relative harm beliefs controlling for baseline beliefs and e-cigarette use||8.26|0.47|0.349
72461165|NCT05129592|144445171|SUPERIORITY||Odds Ratio (OR)|1.76|STANDARD_ERROR_OF_MEAN|1.07||0.355|TWO_SIDED|95.0|0.53|5.81|||Regression, Logistic||Odds of believing e-cigarettes are less harmful than cigarettes in the Nicotine corrective with causal explanation/odds of believing e-cigarettes are less harmful than cigarettes in the condition with both component of coherence|Adjusted logistic regression showing the effect of condition (Nicotine corrective with causal explanation compared to the Nicotine corrective with both components of coherence (reference group)) on e-cigarette relative harm beliefs controlling for baseline beliefs and e-cigarette use||5.81|0.53|0.355
72392742|NCT00730132|144292787|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.81773|STANDARD_ERROR_OF_MEAN|1.88425||0.107|TWO_SIDED|95.0|-8.2523|0.6169|||Games-Howell|||New Statin compared to Ezetimibe||.6169|-8.2523|.107
72392743|NCT00843024|144292849|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2||||0.003|TWO_SIDED|95.0|0.09|0.3||Adjusted for multiplicity according to the fixed sequence testing strategy|Cochran-Mantel-Haenszel||Sumatriptan 10 mg/Naproxen 60 mg minus placebo|||0.30|0.09|0.003
72501444|NCT05818124|144532780|OTHER||Difference in Least Squares Mean|-3.79||||0.045|TWO_SIDED|95.0|-7.47|-0.1|||ANOVA|||||-0.10|-7.47|0.045
72501445|NCT05818124|144532781|OTHER||Difference in Least Squares Mean|-2.56||||0.226|TWO_SIDED|95.0|-6.81|1.69|||ANOVA|||||1.69|-6.81|0.226
72501446|NCT05818124|144532782|OTHER||Difference in Least Squares Mean|-1.6||||0.09|TWO_SIDED|95.0|-3.47|0.27|||ANOVA|||||0.27|-3.47|0.090
72392744|NCT00843024|144292849|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.16||||0.003|TWO_SIDED|95.0|0.07|0.26||Adjusted for multiplicity according to the fixed-sequence testing strategy|Cochran-Mantel-Haenszel||Sumatriptan 30 mg/Naproxen180 mg minus placebo|||0.26|0.07|0.003
72392745|NCT00843024|144292849|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.13||||0.003|TWO_SIDED|95.0|0.05|0.22||Adjusted for multiplicity according to the fixed-sequence testing strategy|Cochran-Mantel-Haenszel||Sumatriptan 85 mg/Naproxen 500 mg minus placebo|||0.22|0.05|0.003
72392746|NCT00006237|144292883|SUPERIORITY_OR_OTHER|||||||0.49||95.0|||||Log Rank|||||||0.49
72392747|NCT00006237|144292884|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||Log Rank|||||||0.02
72392748|NCT02837783|144292904|SUPERIORITY|||||||0.283|||||||Wilcoxon rank sum test|||||||0.283
72392749|NCT02207244|144292919|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Cochran-Mantel-Haenszel chi-square test|||||||< 0.001
72392750|NCT02207244|144292920|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Cochran-Mantel-Haenszel chi-square test|||||||< 0.001
72392751|NCT02207244|144292921|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Cochran-Mantel-Haenszel chi-square test|||||||< 0.001
72392752|NCT02207244|144292922|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Cochran-Mantel-Haenszel chi-square test|||||||< 0.001
72501447|NCT05818124|144532783|OTHER||Difference in Least Squares Mean|0.74||||0.609|TWO_SIDED|95.0|-2.19|3.66|||ANOVA|||||3.66|-2.19|0.609
72461166|NCT05129592|144445171|SUPERIORITY||Odds Ratio (OR)|0.74|STANDARD_ERROR_OF_MEAN|0.42||0.591|TWO_SIDED|95.0|0.24|2.25|||Regression, Logistic||Odds of believing e-cigarettes are less harmful than cigarettes in the Nicotine corrective with reason for misperception/odds of believing e-cigarettes are less harmful than cigarettes in the condition with both component of coherence|Adjusted logistic regression showing the effect of condition (Nicotine corrective with reason for misperception compared to the Nicotine corrective with both components of coherence (reference group)) on e-cigarette relative harm beliefs controlling for baseline beliefs and e-cigarette use||2.25|0.24|0.591
72461167|NCT05129592|144445172|SUPERIORITY|Unadjusted logistic regression showing the effect of condition (Nicotine corrective control compared to the Nicotine corrective with both components of coherence (reference group)) on NRT relative harm beliefs|Odds Ratio (OR)|0.98|STANDARD_ERROR_OF_MEAN|0.99||0.98|TWO_SIDED|95.0|0.13|7.27|||Regression, Logistic||Odds of believing NRT is less harmful than cigarettes in the control condition/odds of believing NRT is less harmful than cigarettes in the condition with both component of coherence|||7.27|0.13|0.980
72461168|NCT05129592|144445172|SUPERIORITY||Odds Ratio (OR)|0.47|STANDARD_ERROR_OF_MEAN|0.41||0.382|TWO_SIDED|95.0|0.09|2.56|||Regression, Logistic||Odds of believing NRT is less harmful than cigarettes in the Nicotine corrective with causal explanation/odds of believing NRT is less harmful than cigarettes in the condition with both component of coherence|Unadjusted logistic regression showing the effect of condition (Nicotine corrective with causal explanation compared to the Nicotine corrective with both components of coherence (reference group)) on NRT relative harm beliefs||2.56|0.09|0.382
72461169|NCT05129592|144445172|SUPERIORITY||Odds Ratio, log|0.83|STANDARD_ERROR_OF_MEAN|0.79||0.846|TWO_SIDED|95.0|0.13|5.23|||Regression, Logistic||Odds of believing NRT is less harmful than cigarettes in the Nicotine corrective with reason for misperception/odds of believing NRT is less harmful than cigarettes in the condition with both component of coherence|Unadjusted logistic regression showing the effect of condition (Nicotine corrective with reason for misperception compared to the Nicotine corrective with both components of coherence (reference group)) on NRT relative harm beliefs||5.23|0.13|0.846
72461170|NCT05129592|144445172|SUPERIORITY||Odds Ratio (OR)|1.01|STANDARD_ERROR_OF_MEAN|1.05||0.99|TWO_SIDED|95.0|0.13|7.74|||Regression, Logistic||Odds of believing NRT is less harmful than cigarettes in the control condition/odds of believing NRT is less harmful than cigarettes in the condition with both component of coherence|Adjusted logistic regression showing the effect of condition (Nicotine corrective control compared to the Nicotine corrective with both components of coherence (reference group)) on NRT relative harm beliefs controlling for NRT use||7.74|0.13|0.990
72501448|NCT05818124|144532784|OTHER|Difference in Least Squares Mean|Difference in Least Squares Mean|0.34||||0.614|TWO_SIDED|95.0|-1.04|1.72|||ANOVA|||||1.72|-1.04|0.614
72501449|NCT05818124|144532785|OTHER||Difference in Least Squares Mean|0.37||||0.608|TWO_SIDED|95.0|-1.09|1.83|||ANOVA|||||1.83|-1.09|0.608
72501450|NCT05818124|144532786|OTHER||Difference in Least Squares Mean|0.43||||0.288|TWO_SIDED|95.0|-0.39|1.25|||ANOVA|||||1.25|-0.39|0.288
72501451|NCT05818124|144532787|OTHER||Difference in Least Squares Mean|0.09||||0.842|TWO_SIDED|95.0|-0.8|0.97|||ANOVA|||||0.97|-0.80|0.842
72563481|NCT02413294|144658217|SUPERIORITY|||||||0.42|||||||Paired T test, 2-sided|||The analysis, like the measures themselves, tracks the significance of the change from end of pre-intervention period to end of intervention period, so while only a single comparison group is listed, because it is all one population group, there are two sets of data for that group.||||0.42
72563482|NCT02413294|144658218|SUPERIORITY|||||||0.65|||||||Paired T test, 2-sided|||The analysis, like the measures themselves, tracks the significance of the change from end of pre-intervention period to end of intervention period, so while only a single comparison group is listed, because it is all one population group, there are two sets of data for that group.||||0.65
72563483|NCT02413294|144658219|SUPERIORITY|||||||1|||||||Fisher Exact|||The analysis, like the measures themselves, tracks the significance of the change from end of pre-intervention period to end of intervention period, so while only a single comparison group is listed, because it is all one population group, there are two sets of data for that group.||||1.0
72501452|NCT05818124|144532790|OTHER||Hazard Ratio (HR)|0.31||||0.0042|TWO_SIDED|95.0|0.14|0.71|||Log Rank||Based on Cox regression model with Efron's method of tie handling with treatment as a covariate|||0.71|0.14|0.0042
72501453|NCT05818124|144532791|OTHER||Hazard Ratio (HR)|0.69||||0.329|TWO_SIDED|95.0|0.33|1.46|||Log Rank||Based on Cox regression model with Efron's method of tie handling with treatment as a covariate|||1.46|0.33|0.3290
72501454|NCT05818124|144532792|OTHER||Hazard Ratio (HR)|0.6||||0.1502|TWO_SIDED|95.0|0.27|1.34|||Log Rank||Based on Cox regression model with Efron's method of tie handling with treatment as a covariate|||1.34|0.27|0.1502
72501455|NCT05818124|144532793|OTHER||Hazard Ratio (HR)|1.32||||0.4865|TWO_SIDED|95.0|0.59|2.92|||Log Rank||Based on Cox regression model with Efron's method of tie handling with treatment as a covariate|||2.92|0.59|0.4865
72501456|NCT05818124|144532796|OTHER||Difference in Least Squares Mean|-4.79||||0.313|TWO_SIDED|95.0|-14.36|4.78|||ANOVA|||||4.78|-14.36|0.313
72501457|NCT05818124|144532797|OTHER||Difference in Least Squares Mean|-6.87||||0.138|TWO_SIDED|95.0|-16.11|2.36|||ANOVA|||||2.36|-16.11|0.138
72501458|NCT05818124|144532798|OTHER||Difference in LS mean|0.74||||0.706|TWO_SIDED|95.0|-3.26|4.74|||ANOVA|||||4.74|-3.26|0.706
72501459|NCT05818124|144532799|OTHER||Difference in LS mean|-1.58||||0.367|TWO_SIDED|95.0|-5.1|1.95|||ANOVA|||||1.95|-5.10|0.367
72501460|NCT05818124|144532805|OTHER||Difference in LS Mean|-4.14||||0.177|TWO_SIDED|95.0|-10.2|1.92|||ANOVA|||||1.92|-10.20|0.177
72563484|NCT02413294|144658220|SUPERIORITY|||||||0.65|||||||Paired T test, 2-sided|||Pre-intervention period means are compared to intervention period means for all subjects.||||0.65
72461171|NCT05129592|144445172|SUPERIORITY||Odds Ratio (OR)|0.51|STANDARD_ERROR_OF_MEAN|0.46||0.458|TWO_SIDED|95.0|0.09|3.01|||Regression, Logistic||Odds of believing NRT is less harmful than cigarettes in the Nicotine corrective with causal explanation/odds of believing NRT is less harmful than cigarettes in the condition with both component of coherence|Adjusted logistic regression showing the effect of condition (Nicotine corrective with causal explanation compared to the Nicotine corrective with both components of coherence (reference group)) on NRT relative harm beliefs controlling for NRT use||3.01|0.09|0.458
72461172|NCT05129592|144445172|SUPERIORITY||Odds Ratio (OR)|0.74|STANDARD_ERROR_OF_MEAN|0.7||0.754|TWO_SIDED|95.0|0.12|4.76|||Regression, Logistic||Odds of believing NRT is less harmful than cigarettes in the Nicotine corrective with reason for misperception/odds of believing NRT is less harmful than cigarettes in the condition with both component of coherence|Adjusted logistic regression showing the effect of condition (Nicotine corrective with reason for misperception compared to the Nicotine corrective with both components of coherence (reference group)) on NRT relative harm beliefs controlling for NRT use||4.76|0.12|0.754
72501461|NCT05818124|144532806|OTHER||Difference in LS mean|-0.97||||0.395|TWO_SIDED|95.0|-3.24|1.29|||ANOVA|||||1.29|-3.24|0.395
72621023|NCT02732145|144773166|SUPERIORITY|"Question: Is there a difference in the diagnostic accuracy of the Vulvoscopy Index as an outcome measure of the diagnostic value of Three Rings Vulvoscopy, and histopathology?"||||||0.6108|||||||t-test proportion|||"Parameter: The difference in the diagnostic accuracy between TRIV using the Vulvoscopy Index and histopathology for detection of vulvar dermatosis."||||0.6108
72621024|NCT02732145|144773167|SUPERIORITY|Question: Is there a difference in the frequency of vulvar complaints among the patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||1|||||||t-test proportion|||Parameter: The difference in the frequency of vulvar complaints in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology.||||1.0000
72621025|NCT02732145|144773167|SUPERIORITY|Question: Is there a difference in the frequency of positive Marinoff Index among the patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||0.9628|||||||t-test proportion|||Parameter: The difference in the frequency of positive Marinoff Index in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology.||||0.9628
72621026|NCT02732145|144773167|SUPERIORITY|Question: Is there a difference in the frequency of the positive Cotton-Swab test among the patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||0.9152|||||||t-test proportion|||Parameter: The difference in the frequency of the positive Cotton-Swab test in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology.||||0.9152
72621027|NCT02732145|144773167|SUPERIORITY|Question: Is there a difference in the frequency of any lesion in any vulvar ring in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||1|||||||t-test proportion|||Parameter: The difference in the frequency of any lesion in any vulvar ring in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology.||||1.0000
72621028|NCT02732145|144773167|SUPERIORITY|Question: Is there a difference in the frequency of any vulvar lesion of the Outer Vulvar Ring among the patients with vulvar dermatosis diagnosed with vulvoscopy and histopathology?||||||0.8862|||||||t-test proportion|||Parameter: The difference in the frequency of any vulvar lesion of the Outer Vulvar Ring in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology.||||0.8862
72621029|NCT02732145|144773167|SUPERIORITY|Question: Is there a difference in the frequency of any vulvar lesion of the Middle Vulvar Ring among the patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||1|||||||t-test proportion|||Parameter: The difference in the frequency of any vulvar lesion of the Middle Vulvar Ring in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology.||||1.0000
72621030|NCT02732145|144773167|SUPERIORITY|Question: Is there a difference in the frequency of any vulvar lesion of the Inner Vulvar Ring among the patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||0.3319|||||||t-test proportion|||Parameter: The difference in the frequency of any vulvar lesion of the Inner Vulvar Ring in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology.||||0.3319
72621031|NCT02732145|144773167|SUPERIORITY|Question: Is there a difference in the frequency of non-specific vulvar lesions among the patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||0.8662|||||||t-test proportion|||Parameter: The difference in the frequency of non-specific vulvar lesions in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology.||||0.8662
72621032|NCT02732145|144773167|SUPERIORITY|Question: Is there a difference in the frequency of specific vulvar lesions among the patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||1|||||||t-test proportion|||Parameter: The difference in the frequency of vulvar lesions specific for dermatosis in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology.||||1.0000
72621033|NCT02732145|144773168|SUPERIORITY|Question: Is there a difference in the frequency of vulvar complaints among the patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||0.5399|||||||t-test proportion|||Parameter: The difference in the frequency of vulvar complaints in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology.||||0.5399
72621034|NCT02732145|144773168|SUPERIORITY|Question: Is there a difference in the frequency of positive Marinoff Index among the patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||0.9248|||||||t-test proportion|||Parameter: The difference in the frequency of positive Marinoff Index in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology.||||0.9248
72621035|NCT02732145|144773168|SUPERIORITY|Question: Is there a difference in the frequency of the positive Cotton-Swab test among the patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||0.9839|||||||t-test proportion|||Parameter: The difference in the frequency of the positive Cotton-Swab test in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology.||||0.9839
72621036|NCT02732145|144773168|SUPERIORITY|Question: Is there a difference in the frequency of any lesion in any vulvar ring among the patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||0.7537|||||||t|||Parameter: The difference in the frequency of any lesion in any vulvar ring in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology.||||0.7537
72501462|NCT05818124|144532818|OTHER|Difference in least squares mean|Difference in least squares means|-0.94||||0.11|TWO_SIDED|95.0|-2.1|0.22|||ANOVA|||||0.22|-2.10|0.110
72501463|NCT05818124|144532819|OTHER||Difference in least squares mean|-1.6||||0.09|TWO_SIDED|95.0|-3.47|0.27|||ANOVA|||||0.27|-3.47|0.090
72392753|NCT02207244|144292923|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Cochran-Mantel-Haenszel chi-square test|||||||< 0.001
72392754|NCT02207244|144292924|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Log Rank|||p value is based on the log-rank test stratified by investigator site (pooled).||||< 0.001
72392755|NCT02207244|144292925|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||ANOVA|||p value is based on analysis of variance (ANOVA) model stratified by investigator site (pooled).||||< 0.001
72501464|NCT01232946|144532838|SUPERIORITY|||||||0.65|||||||Kruskal-Wallis|||||||0.65
72501465|NCT01232946|144532839|SUPERIORITY|||||||0.065|||||||Kruskal-Wallis|||||||0.065
72392756|NCT02207244|144292926|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|non-inferiority margin= -10.0%|Difference in Percentage|16.4|||<|0.001|TWO_SIDED|95.0|10.0|23.2|||MH Z-test|||p value is based on 1-sided Mantel Haenszel (MH) Z-test adjusted for investigator site (pooled).||23.2|10.0|< 0.001
72392757|NCT02207244|144292926|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Cochran-Mantel-Haenszel chi-square test|||p value is based on the Cochran-Mantel-Haenszel chi-square test stratified by investigator site (pooled).||||< 0.001
72392758|NCT02207244|144292927|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|non-inferiority margin= -10.0%|Difference in Percentage|23.3|||<|0.001|TWO_SIDED|95.0|16.0|30.4|||MH Z-test|||p value is based on 1-sided MH Z-test adjusted for investigator site (pooled).||30.4|16.0|< 0.001
72392759|NCT02207244|144292927|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Cochran-Mantel-Haenszel chi-square test|||p value is based on the Cochran-Mantel-Haenszel chi-square test stratified by investigator site (pooled).||||< 0.001
72392760|NCT02207244|144292928|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|non-inferiority margin= -10%|Difference in percentage|17.7|||<|0.001|TWO_SIDED|95.0|11.4|24.4|||MH Z-test|||p value is based on 1-sided MH Z-test adjusted for investigator site (pooled).||24.4|11.4|< 0.001
72392761|NCT02207244|144292928|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Cochran-Mantel-Haenszel chi-square test|||p value is based on the Cochran-Mantel-Haenszel chi-square test stratified by investigator site (pooled).||||< 0.001
72392762|NCT02207244|144292929|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Cochran-Mantel-Haenszel chi-square test|||p value is based on the Cochran-Mantel-Haenszel chi-square test stratified by investigator site (pooled).||||< 0.001
72392763|NCT02207244|144292930|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||ANOVA|||p value is based on ANOVA model stratified by investigator site (pooled).||||< 0.001
72501466|NCT01232946|144532840|SUPERIORITY|||||||0.8|||||||Kruskal-Wallis|||||||0.80
72501467|NCT02210780|144532860|SUPERIORITY||Percentage Difference|34.0|||<|0.0001|TWO_SIDED|90.0|24.29|43.75|||Cochran-Mantel-Haenszel||Dupilumab 300 mg qw vs. Placebo qw|Analysis was performed using Cochran-Mantel-Haenszel test stratified by randomization strata (moderate \[IGA=3\] vs. severe \[IGA=4\] AD).||43.75|24.29|<0.0001
72501468|NCT02210780|144532861|SUPERIORITY||Percentage Difference|40.2|||<|0.0001|TWO_SIDED|90.0|29.4|51.01|||Cochran-Mantel-Haenszel||Dupilumab 300 mg qw vs. Placebo qw|Analysis was performed using Cochran-Mantel-Haenszel test stratified by randomization strata (moderate \[IGA=3\] vs. severe \[IGA=4\] AD).||51.01|29.40|<0.0001
72501469|NCT02210780|144532862|SUPERIORITY||Percentage Difference|34.0|||<|0.0001|TWO_SIDED|90.0|23.38|44.66|||Cochran-Mantel-Haenszel||Dupilumab 300 mg qw vs. Placebo qw|Analysis was performed using Cochran-Mantel-Haenszel test stratified by randomization strata (moderate \[IGA=3\] vs. severe \[IGA=4\] AD).||44.66|23.38|<0.0001
72501470|NCT02210780|144532863|SUPERIORITY||LS Mean Difference|-2.13|STANDARD_ERROR_OF_MEAN|0.354|<|0.0001|TWO_SIDED|90.0|-2.72|-1.55|||ANCOVA||Dupilumab 300 mg qw vs. Placebo qw|Analysis was performed using ANCOVA model which includes treatment, randomization strata, and baseline value as covariates.||-1.55|-2.72|<0.0001
72392764|NCT02207244|144292931|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Cochran-Mantel-Haenszel chi-square test|||p value is based on the Cochran-Mantel-Haenszel chi-square test stratified by investigator site (pooled).||||< 0.001
72392765|NCT02216591|144292939|SUPERIORITY|||||||0.013|||||||ANCOVA|Mixed-model general linear model with age and education included as covariates. Time x arm interaction was significant, F(1,16) = 7.76, p = 0.013.||||||.013
72392766|NCT02216591|144292940|SUPERIORITY|||||||0.274|||||||ANCOVA|Mixed-model general linear model with age and education included as covariates. Time x arm interaction was not significant, F(1,16) = 1.29, p = 0.274||||||.274
72392767|NCT02216591|144292941|SUPERIORITY|||||||0.41|||||||ANCOVA|Mixed-model general linear model with age and education included as covariates. Time x arm interaction was not significant, F(1,16) = .72, p = 0.410||||||.410
72392768|NCT03919799|144292950|SUPERIORITY|The LOCF imputation was followed by logistic regression analysis. Comparison analysis between belumosudil dose regimen and placebo was performed using a logistic regression analysis with treatment in the model.|Odds Ratio (OR)|1.06||||0.9472|TWO_SIDED|95.0|0.19|5.82||Threshold for significance at 0.05 level.|Regression, Logistic|||Belumosudil 200 mg QD versus Placebo||5.82|0.19|0.9472
72392769|NCT03919799|144292950|SUPERIORITY|The LOCF imputation was followed by logistic regression analysis. Comparison analysis between belumosudil dose regimen and placebo was performed using a logistic regression analysis with treatment in the model.|Odds Ratio (OR)|0.39||||0.3078|TWO_SIDED|95.0|0.07|2.35||Threshold for significance at 0.05 level.|Regression, Logistic|||Belumosudil 200 mg BID versus Placebo||2.35|0.07|0.3078
72392770|NCT03919799|144292951|SUPERIORITY|MMRM analysis used rank-transformed data, with CRISS score as a dependent variable and treatment, visit, and visit x treatment interaction as fixed effects. Visit was a repeated factor, and analyses were done through week 24.|Least square mean difference|-0.04||||0.9889|TWO_SIDED|95.0|-6.51|6.42||Threshold for significance at 0.05 level.|MMRM|||Belumosudil 200 mg QD versus Placebo||6.42|-6.51|0.9889
72392771|NCT03919799|144292951|SUPERIORITY|MMRM analysis using rank-transformed data, with CRISS score as a dependent variable and treatment, visit, and visit x treatment interaction as fixed effects. Visit was a repeated factor, and analyses were done through week 24.|Least square mean difference|-4.18||||0.1916|TWO_SIDED|95.0|-10.59|2.23||Threshold for significance at 0.05 level.|MMRM|||Belumosudil 200 mg BID versus Placebo||2.23|-10.59|0.1916
72392772|NCT03919799|144292953|SUPERIORITY||Least square mean difference|-0.6||||0.771|TWO_SIDED|95.0|-4.7|3.6||Threshold for significance at 0.05 level.|MMRM|||Belumosudil 200 mg QD versus Placebo||3.6|-4.7|0.7710
72501471|NCT02210780|144532864|SUPERIORITY||LS Mean Difference|-17.8|STANDARD_ERROR_OF_MEAN|2.84|<|0.0001|TWO_SIDED|90.0|-22.5|-13.1|||ANCOVA||Dupilumab 300 mg qw vs. Placebo qw|Analysis was performed using ANCOVA model that includes treatment, randomization strata and baseline value as covariates.||-13.1|-22.5|<0.0001
72501472|NCT02210780|144532866|SUPERIORITY||LS Mean Difference|-2.4|STANDARD_ERROR_OF_MEAN|0.39|<|0.0001|TWO_SIDED|90.0|-3.0|-1.7|||ANCOVA||Dupilumab 300 mg qw vs. Placebo qw|Analysis was performed using the ANCOVA model which includes treatment, randomization strata, and baseline values as covariates.||-1.7|-3.0|<0.0001
72501473|NCT02210780|144532867|SUPERIORITY||LS Mean Difference|-8.3|STANDARD_ERROR_OF_MEAN|0.99|<|0.0001|TWO_SIDED|90.0|-9.9|-6.6|||ANCOVA||Dupilumab 300 mg qw vs. Placebo qw|Analysis was performed using the ANCOVA model which included treatment, randomization strata, and baseline value as covariates.||-6.6|-9.9|<0.0001
72501474|NCT02469246|144532917|NON_INFERIORITY|Non-inferiority was assessed using a 2-sided exact 95% confidence interval (CI) approach, with a non-inferiority margin of 10%.|Difference in Percentages|-3.8||||0.15|TWO_SIDED|95.002|-8.9|1.1|||Fisher Exact||The difference in percentages and its 95.002% CI were calculated based on an unconditional exact method using 2 inverted 1-sided tests.|The analysis purpose of the primary efficacy endpoint was to assess the noninferiority of switching to F/TAF+3rd Agent relative to maintaining treatment with ABC/3TC+3rd Agent.||1.1|-8.9|0.15
72501475|NCT02469246|144532918|NON_INFERIORITY|Non-inferiority was assessed using a 2-sided exact 95% CI approach, with a non-inferiority margin of 4%.|Difference in Percentages|-6.3||||0.042|TWO_SIDED|95.0|-12.3|-0.3|||Fisher Exact||The difference in percentages and its 95% CI were calculated based on an unconditional exact method using 2 inverted 1-sided tests.|The analysis purpose of this efficacy endpoint was to assess the non-inferiority of switching to F/TAF+3rd Agent relative to maintaining treatment with ABC/3TC+3rd Agent.||-0.3|-12.3|0.042
72501476|NCT02469246|144532919|NON_INFERIORITY|Non-inferiority was assessed using a 2-sided exact 95% CI approach, with a non-inferiority margin of 4%.|Difference in Percentages|1.1||||0.45|TWO_SIDED|95.002|-1.0|3.5|||Fisher Exact||The difference in percentages and its 95.002% CI were calculated based on an unconditional exact method using 2 inverted 1-sided tests.|The analysis purpose of this efficacy endpoint was to assess the non-inferiority of switching to F/TAF+3rd Agent relative to maintaining treatment with ABC/3TC+3rd Agent.||3.5|-1.0|0.45
72501477|NCT02469246|144532920|NON_INFERIORITY|Non-inferiority was assessed using a 2-sided exact 95% CI approach, with a non-inferiority margin of 4%.|Difference in Percentages|1.4||||0.34|TWO_SIDED|95.0|-1.0|4.2|||Fisher Exact||The difference in percentages and its 95% CI were calculated based on an unconditional exact method using 2 inverted 1-sided tests.|The analysis purpose of this efficacy endpoint was to assess the non-inferiority of switching to F/TAF+3rd Agent relative to maintaining treatment with ABC/3TC+3rd Agent.||4.2|-1.0|0.34
72501478|NCT02469246|144532921|NON_INFERIORITY|Non-inferiority was assessed using a 2-sided exact 95% CI approach, with a non-inferiority margin of 10%.|Difference in Percentages|-1.6||||0.62|TWO_SIDED|95.0|-7.4|4.2|||Fisher Exact||The difference in percentages and its 95% CI were calculated based on an unconditional exact method using 2 inverted 1-sided tests.|The analysis purpose of this efficacy endpoint was to assess the noninferiority of switching to F/TAF+3rd Agent relative to maintaining treatment with ABC/3TC+3rd Agent.||4.2|-7.4|0.62
72501479|NCT02469246|144532922|NON_INFERIORITY|Non-inferiority was assessed using a 2-sided exact 95% CI approach, with a non-inferiority margin of 10%.|Difference in Percentages|-5.9||||0.069|TWO_SIDED|95.0|-12.2|0.4|||Fisher Exact||The difference in percentages and its 95% CI were calculated based on an unconditional exact method using 2 inverted 1-sided tests.|The analysis purpose of this efficacy endpoint was to assess the noninferiority of switching to F/TAF+3rd Agent relative to maintaining treatment with ABC/3TC+3rd Agent.||0.4|-12.2|0.069
72501480|NCT02469246|144532923|SUPERIORITY||Difference in LSM|-32.0||||0.026|TWO_SIDED|95.0|-61.0|-4.0||P-value was adjusted by the third agent stratum (boosted protease inhibitors vs. others).|ANOVA||Difference in LSM and its 95% CI were adjusted by the third agent stratum (boosted protease inhibitors vs. others).|||-4|-61|0.026
72501481|NCT02469246|144532924|SUPERIORITY||Difference in LSM|-39.0||||0.013|TWO_SIDED|95.0|-70.0|-8.0||P-value was adjusted by the third agent stratum (boosted protease inhibitors vs. others).|ANOVA||Difference in LSM and its 95% CI were adjusted by the third agent stratum (boosted protease inhibitors vs. others).|||-8|-70|0.013
72501482|NCT02469246|144532925|SUPERIORITY||Difference in LSM|0.179||||0.4|TWO_SIDED|95.0|-0.24|0.598||P-value was adjusted by the third agent stratum (boosted protease inhibitors vs. others).|ANOVA||Difference in LSM and its 95% CI were adjusted by the third agent stratum (boosted protease inhibitors vs. others).|||0.598|-0.240|0.40
72563485|NCT02413294|144658221|SUPERIORITY|||||||0.65|||||||Paired T test, 2-sided|||Pre-intervention period means are compared to intervention period means for all subjects.||||0.65
72563486|NCT02413294|144658222|SUPERIORITY|||||||0.94|||||||Paired T test, 2-sided|||Pre-intervention period means are compared to intervention period means for all subjects.||||0.94
72621037|NCT02732145|144773168|SUPERIORITY|Question: Is there a difference in the frequency of any vulvar lesion of the Outer Vulvar Ring among the patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||0.2054|||||||t-test proportion|||Parameter: The difference in the frequency of any vulvar lesion of the Outer Vulvar Ring in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology.||||0.2054
72621038|NCT02732145|144773168|SUPERIORITY|Question: Is there a difference in the frequency of any vulvar lesion of the Middle Vulvar Ring among the patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||0.6409|||||||t-test proportion|||Parameter: The difference in the frequency of any vulvar lesion of the Middle Vulvar Ring in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology.||||0.6409
72501483|NCT02469246|144532926|SUPERIORITY||Difference in LSM|0.165||||0.53|TWO_SIDED|95.0|-0.348|0.678||P-value was adjusted by the third agent stratum (boosted protease inhibitors vs. others).|ANOVA||Difference in LSM and its 95% CI were adjusted by the third agent stratum (boosted protease inhibitors vs. others).|||0.678|-0.348|0.53
72563487|NCT02413294|144658223|SUPERIORITY|||||||0.81|||||||Paired T test, 2-sided|||Pre-intervention period means are compared to intervention period means for all subjects.||||0.81
72563488|NCT02413294|144658224|SUPERIORITY|||||||0.4|||||||Paired T test, 2-sided|||Pre-intervention period means are compared to intervention period means for all subjects.||||0.40
72461173|NCT05129592|144445173|SUPERIORITY||Odds Ratio, log|1.69|STANDARD_ERROR_OF_MEAN|0.78||0.256|TWO_SIDED|95.0|0.68|4.15|||Regression, Logistic||Odds of believing VLNC are less harmful than cigarettes in the control condition/odds of believing VLNC are less harmful than cigarettes in the condition with both component of coherence|Unadjusted logistic regression showing the effect of condition (Nicotine corrective control compared to the Nicotine corrective with both components of coherence (reference group)) on VLNC relative harm beliefs||4.15|0.68|0.256
72461174|NCT05129592|144445173|SUPERIORITY||Odds Ratio (OR)|1.02|STANDARD_ERROR_OF_MEAN|0.43||0.961|TWO_SIDED|95.0|0.45|2.32|||Regression, Logistic||Odds of believing VLNC are less harmful than cigarettes in the Nicotine corrective with causal explanation/odds of believing VLNC are less harmful than cigarettes in the condition with both component of coherence|Unadjusted logistic regression showing the effect of condition (Nicotine corrective with causal explanation compared to the Nicotine corrective with both components of coherence (reference group)) on VLNC relative harm beliefs||2.32|0.45|0.961
72461175|NCT05129592|144445173|SUPERIORITY||Odds Ratio (OR)|0.67|STANDARD_ERROR_OF_MEAN|0.28||0.345|TWO_SIDED|95.0|0.3|1.53|||Regression, Logistic||Odds of believing VLNC are less harmful than cigarettes in the Nicotine corrective with reason for misperception/odds of believing VLNC are less harmful than cigarettes in the condition with both component of coherence|Unadjusted logistic regression showing the effect of condition (Nicotine corrective with reason for misperception compared to the Nicotine corrective with both components of coherence (reference group)) on VLNC relative harm beliefs||1.53|0.30|0.345
72461176|NCT05129592|144445173|SUPERIORITY||Odds Ratio (OR)|1.56|STANDARD_ERROR_OF_MEAN|0.76||0.36|TWO_SIDED|95.0|0.6|4.04|||Regression, Logistic||Odds of believing VLNC are less harmful than cigarettes in the control condition/odds of believing VLNC are less harmful than cigarettes in the condition with both component of coherence|Adjusted logistic regression showing the effect of condition (Nicotine corrective control compared to the Nicotine corrective with both components of coherence (reference group)) on VLNC relative harm beliefs controlling for baseline beliefs and VLNC use||4.04|0.60|0.360
72461177|NCT05129592|144445173|SUPERIORITY||Odds Ratio (OR)|1.14|STANDARD_ERROR_OF_MEAN|0.5||0.765|TWO_SIDED|95.0|0.48|2.7|||Regression, Logistic||Odds of believing VLNC are less harmful than cigarettes in the Nicotine corrective with causal explanation/odds of believing VLNC are less harmful than cigarettes in the condition with both component of coherence|Adjusted logistic regression showing the effect of condition (Nicotine corrective with causal explanation compared to the Nicotine corrective with both components of coherence (reference group)) on VLNC relative harm beliefs controlling for baseline beliefs and VLNC use||2.70|0.48|0.765
72461178|NCT05129592|144445173|SUPERIORITY||Odds Ratio (OR)|0.6|STANDARD_ERROR_OF_MEAN|0.27||0.252|TWO_SIDED|95.0|0.25|1.43|||Regression, Logistic||Odds of believing VLNC are less harmful than cigarettes in the Nicotine corrective with reason for misperception/odds of believing VLNC are less harmful than cigarettes in the condition with both component of coherence|Adjusted logistic regression showing the effect of condition (Nicotine corrective with reason for misperception compared to the Nicotine corrective with both components of coherence (reference group)) on VLNC relative harm beliefs controlling for baseline beliefs and VLNC use||1.43|0.25|0.252
72461179|NCT05129592|144445174|SUPERIORITY||Odds Ratio (OR)|0.45|STANDARD_ERROR_OF_MEAN|0.2||0.077|TWO_SIDED|95.0|0.18|1.09|||Regression, Logistic||Odds of believing smokeless tobacco is less harmful than cigarettes in the control condition/odds of believing smokeless tobacco is less harmful than cigarettes in the condition with both component of coherence|Unadjusted logistic regression showing the effect of condition (Nicotine corrective control compared to the Nicotine corrective with both components of coherence (reference group)) on smokeless tobacco relative harm beliefs||1.09|0.18|0.077
72461180|NCT05129592|144445174|SUPERIORITY||Odds Ratio (OR)|0.92|STANDARD_ERROR_OF_MEAN|0.4||0.853|TWO_SIDED|95.0|0.4|2.15|||Regression, Logistic|||Unadjusted logistic regression showing the effect of condition (Nicotine corrective with causal explanation compared to the Nicotine corrective with both components of coherence (reference group)) on smokeless tobacco relative harm beliefs|Odds of believing smokeless tobacco is less harmful than cigarettes in the Nicotine corrective with causal explanation/odds of believing smokeless tobacco is less harmful than cigarettes in the condition with both component of coherence|2.15|0.40|0.853
72461181|NCT05129592|144445174|SUPERIORITY||Odds Ratio, log|0.41|STANDARD_ERROR_OF_MEAN|0.18||0.037|TWO_SIDED|95.0|0.18|0.95|||Regression, Logistic||Odds of believing smokeless tobacco is less harmful than cigarettes in the Nicotine corrective with both components of coherence/odds of believing smokeless tobacco is less harmful than cigarettes in the condition with both component of coherence|Unadjusted logistic regression showing the effect of condition (Nicotine corrective with reason for misperception compared to the Nicotine corrective with both components of coherence (reference group)) on smokeless tobacco relative harm beliefs||0.95|0.18|0.037
72461182|NCT05129592|144445174|SUPERIORITY||Odds Ratio (OR)|0.6|STANDARD_ERROR_OF_MEAN|0.33||0.349|TWO_SIDED|95.0|0.21|1.75|||Regression, Logistic||Odds of believing smokeless tobacco is less harmful than cigarettes in the control condition/odds of believing smokeless tobacco is less harmful than cigarettes in the condition with both component of coherence|Adjusted logistic regression showing the effect of condition (Nicotine corrective control compared to the Nicotine corrective with both components of coherence (reference group)) on smokeless relative harm beliefs controlling for baseline beliefs and smokeless tobacco use||1.75|0.21|0.349
72501484|NCT02469246|144532927|SUPERIORITY||Difference in LSM|0.151||||0.63|TWO_SIDED|95.0|-0.465|0.767||P-value was adjusted by the third agent stratum (boosted protease inhibitors vs. others).|ANOVA||Difference in LSM and its 95% CI were adjusted by the third agent stratum (boosted protease inhibitors vs. others).|||0.767|-0.465|0.63
72501485|NCT02469246|144532928|SUPERIORITY||Difference in LSM|-0.056||||0.89|TWO_SIDED|95.0|-0.825|0.713||P-value was adjusted by the third agent stratum (boosted protease inhibitors vs. others).|ANOVA||Difference in LSM and its 95% CI were adjusted by the third agent stratum (boosted protease inhibitors vs. others).|||0.713|-0.825|0.89
72501486|NCT00636818|144532933|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Change from Baseline. Change=Endpoint minus Baseline.|t-test, 2 sided|||||||<0.001
72501487|NCT00636818|144532934|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Change from Baseline. Change=Endpoint minus Baseline.|t-test, 2 sided|||||||<0.001
72392773|NCT03919799|144292953|SUPERIORITY||Least square mean difference|4.6||||0.0308|TWO_SIDED|95.0|0.5|8.8||Threshold for significance at 0.05 level.|MMRM|||Belumosudil 200 mg BID versus Placebo||8.8|0.5|0.0308
72461183|NCT05129592|144445174|SUPERIORITY||Odds Ratio (OR)|1.45|STANDARD_ERROR_OF_MEAN|0.74||0.464|TWO_SIDED|95.0|0.54|3.93|||Regression, Logistic||Odds of believing smokeless tobacco is less harmful than cigarettes in the Nicotine corrective with causal explanation/odds of believing smokeless tobacco is less harmful than cigarettes in the condition with both component of coherence|Adjusted logistic regression showing the effect of condition (Nicotine corrective with causal explanation compared to the Nicotine corrective with both components of coherence (reference group)) on smokeless relative harm beliefs controlling for baseline beliefs and smokeless tobacco use||3.93|0.54|0.464
72461184|NCT05129592|144445174|SUPERIORITY||Odds Ratio (OR)|0.5|STANDARD_ERROR_OF_MEAN|0.26||0.187|TWO_SIDED|95.0|0.18|1.4|||Regression, Logistic||Odds of believing smokeless tobacco is less harmful than cigarettes in the Nicotine corrective with reason for misperception/odds of believing smokeless tobacco is less harmful than cigarettes in the condition with both component of coherence|Adjusted logistic regression showing the effect of condition (Nicotine corrective with reason for misperception compared to the Nicotine corrective with both components of coherence (reference group)) on smokeless relative harm beliefs controlling for baseline beliefs and smokeless tobacco use||1.40|0.18|0.187
72461185|NCT05129592|144445175|SUPERIORITY||Odds Ratio (OR)|1.06|STANDARD_ERROR_OF_MEAN|0.66||0.925|TWO_SIDED|95.0|0.31|3.62|||Regression, Logistic||Odds of believing cigarillos are less harmful than cigarettes in the control condition/odds of believing cigarillos are less harmful than cigarettes in the condition with both component of coherence|Unadjusted logistic regression showing the effect of condition (Nicotine corrective control compared to the Nicotine corrective with both components of coherence (reference group)) on cigarillo relative harm beliefs||3.62|0.31|0.925
72461186|NCT05129592|144445175|SUPERIORITY||Odds Ratio (OR)|0.66|STANDARD_ERROR_OF_MEAN|0.43||0.525|TWO_SIDED|95.0|0.19|2.35|||Regression, Logistic||Odds of believing cigarillos are less harmful than cigarettes in the Nicotine corrective with causal explanation/odds of believing cigarillos are less harmful than cigarettes in the condition with both component of coherence|Unadjusted logistic regression showing the effect of condition (Nicotine corrective with causal explanation compared to the Nicotine corrective with both components of coherence (reference group)) on cigarillo relative harm beliefs||2.35|0.19|0.525
72461187|NCT05129592|144445175|SUPERIORITY||Odds Ratio (OR)|0.71|STANDARD_ERROR_OF_MEAN|0.44||0.586|TWO_SIDED|95.0|0.21|2.4|||Regression, Logistic||Odds of believing cigarillos are less harmful than cigarettes in the Nicotine corrective with reason for misperception/odds of believing cigarillos are less harmful than cigarettes in the condition with both component of coherence|Unadjusted logistic regression showing the effect of condition (Nicotine corrective with reason for misperception compared to the Nicotine corrective with both components of coherence (reference group)) on cigarillo relative harm beliefs||2.40|0.21|0.586
72461188|NCT05129592|144445175|SUPERIORITY||Odds Ratio (OR)|1.1|STANDARD_ERROR_OF_MEAN|0.71||0.883|TWO_SIDED|95.0|0.31|3.9|||Regression, Logistic||Odds of believing cigarillos are less harmful than cigarettes in the control condition/odds of believing cigarillos are less harmful than cigarettes in the condition with both component of coherence|Adjusted logistic regression showing the effect of condition (Nicotine corrective control compared to the Nicotine corrective with both components of coherence (reference group)) on cigarillo relative harm beliefs controlling for smokeless tobacco use||3.90|0.31|0.883
72461189|NCT05129592|144445175|SUPERIORITY||Odds Ratio (OR)|0.66|STANDARD_ERROR_OF_MEAN|0.44||0.534|TWO_SIDED|95.0|0.18|2.41|||Regression, Logistic||Odds of believing cigarillos are less harmful than cigarettes in the Nicotine corrective with causal explanation/odds of believing cigarillos are less harmful than cigarettes in the condition with both component of coherence|Adjusted logistic regression showing the effect of condition (Nicotine corrective with causal explanation compared to the Nicotine corrective with both components of coherence (reference group)) on cigarillo relative harm beliefs controlling for smokeless tobacco use||2.41|0.18|0.534
72461190|NCT05129592|144445175|SUPERIORITY||Odds Ratio (OR)|0.76|STANDARD_ERROR_OF_MEAN|0.48||0.661|TWO_SIDED|95.0|0.22|2.62|||Regression, Logistic||Odds of believing cigarillos are less harmful than cigarettes in the Nicotine corrective with reason for misperception/odds of believing cigarillos are less harmful than cigarettes in the condition with both component of coherence|Adjusted logistic regression showing the effect of condition (Nicotine corrective with reason for misperception compared to the Nicotine corrective with both components of coherence (reference group)) on cigarillo relative harm beliefs controlling for smokeless tobacco use||2.62|0.22|0.661
72461191|NCT05129592|144445176|SUPERIORITY||Mean Difference (Final Values)|1.97|STANDARD_ERROR_OF_MEAN|4.66||0.965|TWO_SIDED|95.0|-9.25|13.19|||ANCOVA|Sidak's adjusted p-value (df=4)|Nicotine corrective control - Nicotine corrective with both components of coherence|ANCOVA adjusted for baseline consideration of switching||13.19|-9.25|0.965
72461192|NCT05129592|144445176|SUPERIORITY||Mean Difference (Final Values)|1.57|STANDARD_ERROR_OF_MEAN|4.44||0.979|TWO_SIDED|95.0|-9.13|12.27|||ANCOVA|Sidak's adjusted p-value (df=4)||ANCOVA adjusted for baseline consideration of switching|Nicotine corrective with causal explanation - Nicotine corrective with both components of coherence|12.27|-9.13|0.979
72461193|NCT05129592|144445176|SUPERIORITY||Mean Difference (Final Values)|4.07|STANDARD_ERROR_OF_MEAN|4.37||0.73|TWO_SIDED|95.0|-6.46|14.59|||ANCOVA|Sidak's adjusted p-value (df=4)||ANCOVA adjusted for baseline consideration of switching|Nicotine corrective with reason for misperception - Nicotine corrective with both components of coherence|14.59|-6.46|0.73
72461194|NCT01234675|144445187|SUPERIORITY||Paired difference|4.6||||0.424|TWO_SIDED|95.0|-7.3|16.6|||Paired T test|||||16.6|-7.3|0.424
72461195|NCT01234675|144445188|SUPERIORITY||Paired difference|-6.1||||0.049|TWO_SIDED|95.0|-12.2|-0.04|||Paired T test|||||-0.04|-12.2|0.049
72392774|NCT03919799|144292954|SUPERIORITY||Least square mean difference|1.4||||0.6533|TWO_SIDED|95.0|-4.9|7.7||Threshold for significance at 0.05 level.|MMRM|||Belumosudil 200 mg QD versus Placebo||7.7|-4.9|0.6533
72461196|NCT01234675|144445189|SUPERIORITY||Paired difference|22.6||||0.056|TWO_SIDED|95.0|-0.6|45.8|||Paired T test|||||45.8|-0.6|0.056
72461197|NCT01234675|144445190|SUPERIORITY||Paired difference|-6.1||||0.683|TWO_SIDED|95.0|-12.5|18.5|||Paired T test|||||18.5|-12.5|0.683
72392775|NCT03919799|144292954|SUPERIORITY||Least square mean difference|-1.5||||0.6338|TWO_SIDED|95.0|-8.1|5.0||Threshold for significance at 0.05 level.|MMRM|||Belumosudil 200 mg BID versus Placebo||5.0|-8.1|0.6338
72501488|NCT00636818|144532935|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Change from Baseline. Change=Endpoint minus Baseline.|t-test, 2 sided|||||||<0.001
72392776|NCT03919799|144292955|SUPERIORITY||Least square mean difference|14.6||||0.0916|TWO_SIDED|95.0|-2.5|31.8||Threshold for significance at 0.05 level.|MMRM|||Belumosudil 200 mg QD versus Placebo||31.8|-2.5|0.0916
72392777|NCT03919799|144292955|SUPERIORITY||Least square mean difference|-8.6||||0.3146|TWO_SIDED|95.0|-25.7|8.6|||MMRM|||Belumosudil 200 mg BID versus Placebo||8.6|-25.7|0.3146
72392778|NCT03919799|144292956|SUPERIORITY||Least square mean difference|-10.0||||0.3753|TWO_SIDED|95.0|-32.8|12.8||Threshold for significance at 0.05 level.|MMRM|||Belumosudil 200 mg QD versus Placebo||12.8|-32.8|0.3753
72392779|NCT03919799|144292956|SUPERIORITY||Least square mean difference|-0.7||||0.9481|TWO_SIDED|95.0|-23.5|22.1||Threshold for significance at 0.05 level.|MMRM|||Belumosudil 200 mg BID versus Placebo||22.1|-23.5|0.9481
72392780|NCT03919799|144292957|SUPERIORITY||Least square mean difference|-0.036||||0.8387|TWO_SIDED|95.0|-0.392|0.32||Threshold for significance at 0.05 level.|MMRM|||Belumosudil 200 mg QD versus Placebo||0.320|-0.392|0.8387
72392781|NCT03919799|144292957|SUPERIORITY||Least square mean difference|0.039||||0.8234|TWO_SIDED|95.0|-0.317|0.395||Threshold for significance at 0.05 level.|MMRM|||Belumosudil 200 mg BID versus Placebo||0.395|-0.317|0.8234
72392782|NCT03919799|144292958|SUPERIORITY||Least square mean difference|-3.009||||0.7535|TWO_SIDED|95.0|-22.413|16.395||Threshold for significance at 0.05 level.|MMRM|||Belumosudil 200 mg QD versus Placebo||16.395|-22.413|0.7535
72392783|NCT03919799|144292958|SUPERIORITY||Least square mean difference|-21.015||||0.0348|TWO_SIDED|95.0|-40.419|-1.611||Threshold for significance at 0.05 level.|MMRM|||Belumosudil 200 mg BID versus Placebo||-1.611|-40.419|0.0348
72392784|NCT03919799|144292959|SUPERIORITY||Least square mean difference|45.566||||0.0343|TWO_SIDED|95.0|3.621|87.512||Threshold for significance at 0.05 level.|MMRM|||Belumosudil 200 mg QD versus Placebo||87.512|3.621|0.0343
72461198|NCT01234675|144445191|SUPERIORITY||Paired difference|-1.502||||0.155|TWO_SIDED|95.0|-59.1|10.4|||Paired T test|||||10.4|-59.1|0.155
72461199|NCT01234675|144445192|SUPERIORITY||Paired difference|-1.0||||0.805|TWO_SIDED|95.0|-9.8|7.8|||Paired T test|||||7.8|-9.8|0.805
72461200|NCT01234675|144445193|SUPERIORITY||Paired difference|-1.0||||0.844|TWO_SIDED|95.0|-11.6|9.6|||Paired T test|||||9.6|-11.6|0.844
72501489|NCT00636818|144532936|SUPERIORITY_OR_OTHER|||||||0.013||95.0||||P-value for Change from Baseline. Change=Endpoint minus Baseline.|t-test, 2 sided|||||||0.013
72501490|NCT00636818|144532937|SUPERIORITY_OR_OTHER|||||||0.005||95.0||||P-value for Change from Baseline. Change=Endpoint minus Baseline.|t-test, 2 sided|||||||0.005
72392785|NCT03919799|144292959|SUPERIORITY||Least square mean difference|-21.984||||0.2922|TWO_SIDED|95.0|-63.93|19.962||Threshold for significance at 0.05 level.|MMRM|||Belumosudil 200 mg BID versus Placebo||19.962|-63.930|0.2922
72392786|NCT03919799|144292960|SUPERIORITY||Least square mean difference|-16.757||||0.532|TWO_SIDED|95.0|-70.933|37.419||Threshold for significance at 0.05 level.|MMRM|||Belumosudil 200 mg QD versus Placebo||37.419|-70.933|0.5320
72392787|NCT03919799|144292960|SUPERIORITY||Least square mean difference|4.02||||0.8804|TWO_SIDED|95.0|-50.156|58.196||Threshold for significance at 0.05 level.|MMRM|||Belumosudil 200 mg BID versus Placebo||58.196|-50.156|0.8804
72392788|NCT03919799|144292961|SUPERIORITY||Least square mean difference|7.522||||0.8628|TWO_SIDED|95.0|-80.837|95.88||Threshold for significance at 0.05 level.|MMRM|||Belumosudil 200 mg QD versus Placebo||95.880|-80.837|0.8628
72392789|NCT03919799|144292961|SUPERIORITY||Least square mean difference|-42.442||||0.3196|TWO_SIDED|95.0|-128.242|43.359|||MMRM|||Belumosudil 200 mg BID versus Placebo||43.359|-128.242|0.3196
72392790|NCT00534430|144293034|EQUIVALENCE|Given the small sample-size of the disease sub-groups, this was a hypothesis generating study.|Median Difference (Net)|0.0|||>|0.05|TWO_SIDED|||||Not adjusted for multiple comparisons. A-priori threshold for statistical significance was 0.05.|Log Rank|No adjustments.||Log-rank test. (Mantel-Haenszel test). Null hypothesis is all four groups are statistically from the same population. Alternative hypothesis is that at least one of the groups is from a population different from the remaining groups. Anticipated sample-sizes comparing Active ALL (anticipated N= 12) with the combined AML patients (anticipated N=38) was deemed to be too small for formal hypothesis testing.||||>0.05
72392791|NCT00534430|144293035|EQUIVALENCE|Given the small sample-size of the disease sub-groups, this was a hypothesis generating study.|Median Difference (Net)|0.0|||>|0.05|TWO_SIDED|||||Not adjusted for multiple comparisons. A-priori threshold for statistical significance was 0.05.|Gray's Test|No adjustments.||Gray's estimate. (Fine and Gray). Null hypothesis is all four groups are statistically from the same population. Alternative hypothesis is that at least one of the groups is from a population different from the remaining groups. Anticipated sample-sizes comparing Active ALL (anticipated N= 12) with the combined AML patients (anticipated N=38) was deemed to be too small for formal hypothesis testing||||>0.05
72461201|NCT01234675|144445194|SUPERIORITY||Paired difference|2.9||||0.509|TWO_SIDED|95.0|-6.4|12.2|||Paired T test|||||12.2|-6.4|0.509
72461202|NCT01234675|144445195|SUPERIORITY||Paired difference|0.32||||0.3|TWO_SIDED|95.0|-0.3|0.6|||Paired T test|||||0.6|-0.3|0.3
72461203|NCT01234675|144445196|SUPERIORITY||Paired difference|-1.03||||0.685|TWO_SIDED|95.0|-8.2|5.6|||Paired T test|||||5.6|-8.2|0.685
72461204|NCT01234675|144445197|SUPERIORITY||Paired difference|-5.3||||0.349|TWO_SIDED|95.0|-17.0|6.4|||Paired T test|||||6.4|-17.0|0.349
72461205|NCT01234675|144445198|SUPERIORITY||Paired difference|-0.6||||0.305|TWO_SIDED|95.0|-1.8|5.6|||Paired T test|||||5.6|-1.8|0.305
72461206|NCT01234675|144445199|SUPERIORITY||Paired difference|-0.5||||0.425|TWO_SIDED|95.0|-1.8|0.8|||Paired T test|||||0.8|-1.8|0.425
72461207|NCT00609245|144445200|SUPERIORITY_OR_OTHER|||||||0.016|||||||ANOVA|||||||0.016
72501491|NCT00636818|144532938|SUPERIORITY_OR_OTHER|||||||0.005||95.0||||P-value for Word Test: Change from Baseline. Change=Endpoint minus Baseline.|t-test, 2 sided|||||||0.005
72501492|NCT00636818|144532938|SUPERIORITY_OR_OTHER|||||||0.005||95.0||||P-value for Color Test: Change from Baseline. Change=Endpoint minus Baseline.|t-test, 2 sided|||||||0.005
72501493|NCT00636818|144532938|SUPERIORITY_OR_OTHER|||||||0.144||95.0||||P-value for Color-Word Test: Change from Baseline. Change=Endpoint minus Baseline.|t-test, 2 sided|||||||0.144
72461208|NCT02889809|144445201|OTHER||Least Square (LS) Mean Difference|-0.16|||||TWO_SIDED|95.0|-0.462|0.142|||||Analysis was performed using an analysis of covariance (ANCOVA) model adjusting for Baseline growth velocity, age at Visit 1, gender and country.|||0.142|-0.462|
72461209|NCT02889809|144445204|OTHER||LS Mean Difference|0.059|||||TWO_SIDED|95.0|-0.455|0.572|||||Analysis was performed using an ANCOVA model adjusting for Baseline growth velocity, age at Visit 1(wk -16), gender and country|||0.572|-0.455|
72461210|NCT05065918|144445208|SUPERIORITY||Slope|-0.536||||0.448|TWO_SIDED|95.0|-1.929|0.857|||Regression, Linear|||Pilot sample size considerations: Assessing 70 students per arm (total n=140) that have completed the program and follow up would provide sufficient data on the full RCT protocol across multiple campuses as well as estimates of intervention effects. Assuming a retention rate of 70% for the three-month follow up, we would need to enroll 200 participants at baseline. We do not anticipate sufficient power to detect statistically and clinically significant results.||0.857|-1.929|0.448
72461211|NCT05065918|144445209|SUPERIORITY||Slope|0.99||||0.969|TWO_SIDED|95.0|-1.152|1.108|||Regression, Linear|||Pilot sample size considerations: Assessing 70 students per arm (total n=140) that have completed the program and follow up would provide sufficient data on the full RCT protocol across multiple campuses as well as estimates of intervention effects. Assuming a retention rate of 70% for the three-month follow up, we would need to enroll 200 participants at baseline. We do not anticipate sufficient power to detect statistically and clinically significant results.||1.108|-1.152|0.969
72461212|NCT05065918|144445210|SUPERIORITY||Slope|-0.5||||0.231|TWO_SIDED|95.0|-1.322|0.322|||Regression, Linear|||Pilot sample size considerations: Assessing 70 students per arm (total n=140) that have completed the program and follow up would provide sufficient data on the full RCT protocol across multiple campuses as well as estimates of intervention effects. Assuming a retention rate of 70% for the three-month follow up, we would need to enroll 200 participants at baseline. We do not anticipate sufficient power to detect statistically and clinically significant results.||.322|-1.322|0.231
72461213|NCT05065918|144445211|SUPERIORITY||Slope|-0.319||||0.398|TWO_SIDED|95.0|-1.064|0.425|||Regression, Linear|||Pilot sample size considerations: Assessing 70 students per arm (total n=140) that have completed the program and follow up would provide sufficient data on the full RCT protocol across multiple campuses as well as estimates of intervention effects. Assuming a retention rate of 70% for the three-month follow up, we would need to enroll 200 participants at baseline. We do not anticipate sufficient power to detect statistically and clinically significant results.||.425|-1.064|0.398
72461214|NCT05065918|144445212|SUPERIORITY||Slope|0.284||||0.382|TWO_SIDED|95.0|-0.356|0.924|||Regression, Linear|||Pilot sample size considerations: Assessing 70 students per arm (total n=140) that have completed the program and follow up would provide sufficient data on the full RCT protocol across multiple campuses as well as estimates of intervention effects. Assuming a retention rate of 70% for the three-month follow up, we would need to enroll 200 participants at baseline. We do not anticipate sufficient power to detect statistically and clinically significant results.||.924|-.356|0.382
72461215|NCT05065918|144445213|SUPERIORITY||Slope|0.382||||0.266|TWO_SIDED|95.0|-0.284|1.025|||Regression, Linear|||Pilot sample size considerations: Assessing 70 students per arm (total n=140) that have completed the program and follow up would provide sufficient data on the full RCT protocol across multiple campuses as well as estimates of intervention effects. Assuming a retention rate of 70% for the three-month follow up, we would need to enroll 200 participants at baseline. We do not anticipate sufficient power to detect statistically and clinically significant results.||1.025|-.284|0.266
72461216|NCT05065918|144445214|SUPERIORITY||Slope|0.53||||0.019|TWO_SIDED|95.0|0.089|0.97|||Regression, Linear|||||.970|0.089|0.019
72461217|NCT05065918|144445215|SUPERIORITY||Slope|0.277||||0.284|TWO_SIDED|95.0|-0.232|0.787|||Regression, Linear|||Pilot sample size considerations: Assessing 70 students per arm (total n=140) that have completed the program and follow up would provide sufficient data on the full RCT protocol across multiple campuses as well as estimates of intervention effects. Assuming a retention rate of 70% for the three-month follow up, we would need to enroll 200 participants at baseline. We do not anticipate sufficient power to detect statistically and clinically significant results.||0.787|-.232|0.284
72461218|NCT05065918|144445216|SUPERIORITY||Slope|0.709||||0.076|TWO_SIDED|95.0|-0.076|1.494|||Regression, Linear|||Pilot sample size considerations: Assessing 70 students per arm (total n=140) that have completed the program and follow up would provide sufficient data on the full RCT protocol across multiple campuses as well as estimates of intervention effects. Assuming a retention rate of 70% for the three-month follow up, we would need to enroll 200 participants at baseline. We do not anticipate sufficient power to detect statistically and clinically significant results.||1.494|-.076|0.076
72461219|NCT05065918|144445217|SUPERIORITY||Slope|0.625||||0.136|TWO_SIDED|95.0|-0.199|1.449|||Regression, Linear|||Pilot sample size considerations: Assessing 70 students per arm (total n=140) that have completed the program and follow up would provide sufficient data on the full RCT protocol across multiple campuses as well as estimates of intervention effects. Assuming a retention rate of 70% for the three-month follow up, we would need to enroll 200 participants at baseline. We do not anticipate sufficient power to detect statistically and clinically significant results.||1.449|-.199|0.136
72461220|NCT03034772|144445229|SUPERIORITY|||||||0.04|||||||ANCOVA|Mean difference between the 2 groups derived using analysis of covariance, with the baseline value and type of anti-VEGF drug used as covariates.||||||0.04
72461221|NCT03034772|144445230|SUPERIORITY|||||||0.11|||||||ANCOVA|Mean difference between the 2 groups derived using analysis of covariance, with the baseline value and type of anti-VEGF drug used as covariates.||||||0.11
72501494|NCT00636818|144532939|SUPERIORITY_OR_OTHER|||||||0.791||95.0||||P-value for Physical Component Summary: Change from Baseline. Change=Endpoint minus Baseline.|t-test, 2 sided|||||||0.791
72461222|NCT03034772|144445231|SUPERIORITY|||||||0.01|||||||ANCOVA|Mean difference between the 2 groups derived using analysis of covariance, with the baseline value and type of anti-VEGF drug used as covariates.||||||0.01
72461223|NCT03034772|144445232|SUPERIORITY|||||||0.78|||||||ANCOVA|||||||0.78
72461224|NCT03034772|144445233|SUPERIORITY|||||||0.24|||||||ANCOVA|||||||0.24
72461225|NCT01533181|144445268|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|3.9||||0.0001|TWO_SIDED|95.0|1.9|8.1|||Kaplan-Meier|||||8.1|1.9|0.0001
72461226|NCT01533181|144445271|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.1||||0.71|TWO_SIDED|95.0|0.6|2.2|||Kaplan-Meier|||||2.2|0.6|0.71
72501495|NCT00636818|144532939|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Mental Component Summary: Change from Baseline. Change=Endpoint minus Baseline.|t-test, 2 sided|||||||<0.001
72501496|NCT00636818|144532939|SUPERIORITY_OR_OTHER|||||||0.037||95.0||||P-value for Physical Functioning: Change from Baseline. Change=Endpoint minus Baseline.|t-test, 2 sided|||||||0.037
72501497|NCT00636818|144532939|SUPERIORITY_OR_OTHER|||||||0.446||95.0||||P-value for Role-Physical: Change from Baseline. Change=Endpoint minus Baseline.|t-test, 2 sided|||||||0.446
72501498|NCT00636818|144532939|SUPERIORITY_OR_OTHER|||||||0.365||95.0||||P-value for Bodily Pain: Change from Baseline. Change=Endpoint minus Baseline.|t-test, 2 sided|||||||0.365
72501499|NCT00636818|144532939|SUPERIORITY_OR_OTHER|||||||0.087||95.0||||P-value for General Health Perception: Change from Baseline. Change=Endpoint minus Baseline.|t-test, 2 sided|||||||0.087
72501500|NCT00636818|144532939|SUPERIORITY_OR_OTHER|||||||0.043||95.0||||P-value for Vitality: Change from Baseline. Change=Endpoint minus Baseline.|t-test, 2 sided|||||||0.043
72501501|NCT00636818|144532939|SUPERIORITY_OR_OTHER|||||||0.086||95.0||||P-value for Social Functioning: Change from Baseline. Change=Endpoint minus Baseline.|t-test, 2 sided|||||||0.086
72501502|NCT00636818|144532939|SUPERIORITY_OR_OTHER|||||||0.01||95.0||||P-value for Role-Emotional: Change from Baseline. Change=Endpoint minus Baseline.|t-test, 2 sided|||||||0.010
72501503|NCT00636818|144532939|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Mental Health: Change from Baseline. Change=Endpoint minus Baseline.|t-test, 2 sided|||||||<0.001
72501504|NCT01658514|144532959|SUPERIORITY_OR_OTHER||% Ratio of LS Means|51.5||||0.0011|TWO_SIDED|90.0|37.77|70.23||p-values \<0.10 are considered statistically significant|ANOVA|Included treatment, renal group, sequence, period and treatment\*renal group as fixed effects and subject nested within sequence as a random effect.||For the Normal Renal Function Cohort. Met XR is the denominator for the % ratio of LS means and the comparator for the p-values.||70.23|37.77|0.0011
72563489|NCT02413294|144658225|SUPERIORITY|||||||0.46|||||||Paired T test, 2-sided|||Pre-intervention period means are compared to intervention period means for all subjects.||||0.46
72392792|NCT01411774|144293139|SUPERIORITY|||||||0.95||||||p \< .05 was the threshold of significance.|Mixed Models Analysis|Analysis for the outcomes used linear mixed-effects models, with treatment group as the between-participant factor and time as the within group factor||||||.95
72563490|NCT02413294|144658226|SUPERIORITY||||||<|0.01|||||||Paired T test, 2-sided|||Pre-intervention period means are compared to intervention period means for all subjects.||||<0.01
72501505|NCT01658514|144532959|SUPERIORITY_OR_OTHER||% Ratio of LS Means|73.8||||0.0733|TWO_SIDED|90.0|55.97|97.43||p-values \<0.10 are considered statistically significant|ANOVA|Included treatment, renal group, sequence, period and treatment\*renal group as fixed effects and subject nested within sequence as a random effect.||For the Mild RI Renal Function Cohort. Met XR is the denominator for the % ratio of LS means and the comparator for the p-values.||97.43|55.97|0.0733
72501506|NCT01658514|144532959|SUPERIORITY_OR_OTHER||% Ratio of LS Means|56.7||||0.0028|TWO_SIDED|90.0|42.25|76.1||p-values \<0.10 are considered statistically significant|ANOVA|Included treatment, renal group, sequence, period and treatment\*renal group as fixed effects and subject nested within sequence as a random effect.||For the Moderate RI Renal Function Cohort. Met XR is the denominator for the % ratio of LS means and the comparator for the p-values.||76.10|42.25|0.0028
72501507|NCT01658514|144532959|SUPERIORITY_OR_OTHER||% Ratio of LS Means|52.4||||0.0025|TWO_SIDED|90.0|37.61|73.02||p-values \<0.10 are considered statistically significant|ANOVA|Included treatment, renal group, sequence, period and treatment\*renal group as fixed effects and subject nested within sequence as a random effect.||For the Severe RI Cohort. Met XR is the denominator for the % ratio of LS means and the comparator for the p-values.||73.02|37.61|0.0025
72501508|NCT01658514|144532960|SUPERIORITY_OR_OTHER||% Ratio of LS Means|65.5||||0.0474|TWO_SIDED|90.0|46.32|92.68||p-values \<0.10 are considered statistically significant|ANOVA|Included treatment, renal group, sequence, period and treatment\*renal group as fixed effects and subject nested within sequence as a random effect.||For the Normal Renal Function Cohort. Met XR is the denominator for the % ratio of LS means and the comparator for the p-values.||92.68|46.32|0.0474
72501509|NCT01658514|144532960|SUPERIORITY_OR_OTHER||% Ratio of LS Means|77.3||||0.1691|TWO_SIDED|90.0|56.72|105.41||p-values \<0.10 are considered statistically significant|ANOVA|Included treatment, renal group, sequence, period and treatment\*renal group as fixed effects and subject nested within sequence as a random effect.||For the Mild RI Renal Function Cohort. Met XR is the denominator for the % ratio of LS means and the comparator for the p-values.||105.41|56.72|0.1691
72501510|NCT01658514|144532960|SUPERIORITY_OR_OTHER||% Ratio of LS Means|56.6||||0.0064|TWO_SIDED|90.0|40.73|78.63||p-values \<0.10 are considered statistically significant|ANOVA|Included treatment, renal group, sequence, period and treatment\*renal group as fixed effects and subject nested within sequence as a random effect.||For the Moderate RI Renal Function Cohort. Met XR is the denominator for the % ratio of LS means and the comparator for the p-values.||78.63|40.73|0.0064
72501511|NCT01658514|144532960|SUPERIORITY_OR_OTHER||% Ratio of LS Means|54.6||||0.0097|TWO_SIDED|90.0|37.68|79.11||p-values \<0.10 are considered statistically significant|ANOVA|Included treatment, renal group, sequence, period and treatment\*renal group as fixed effects and subject nested within sequence as a random effect.||For the Severe RI Renal Function Cohort. Met XR is the denominator for the % ratio of LS means and the comparator for the p-values.||79.11|37.68|0.0097
72501512|NCT01658514|144532961|SUPERIORITY_OR_OTHER|||||||0.9444|TWO_SIDED|||||R² for Placebo-adjusted Change from Pre-dose Value in Lactate Versus Metformin Concentration|Pearson Correlation|||||||0.9444
72501513|NCT01658514|144532961|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||R² for placebo-adjusted change from pre-dose value in lactate versus metformin concentration|Pearson Correlation|||||||<0.0001
72501514|NCT01642212|144532975|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||Fisher Exact|||||||<0.0001
72501515|NCT01642212|144532976|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-6.75||||0.0096|TWO_SIDED|95.0|-11.808|-1.687||LS mean estimates were determined using an ANCOVA model including treatment group as a factor and the baseline score as a covariate.|ANCOVA|||||-1.687|-11.808|0.0096
72563491|NCT02413294|144658227|SUPERIORITY|||||||0.28|||||||Paired T test, 2-sided|||Pre-intervention period means are compared to intervention period means for all subjects.||||0.28
72392793|NCT00279591|144293142|SUPERIORITY_OR_OTHER|||||||0.03||95.0|||||Fisher Exact|||||||0.03
72621039|NCT02732145|144773168|SUPERIORITY|Question: Is there a difference in the frequency of any vulvar lesion of the Inner Vulvar Ring among the patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||0.9753|||||||t-test proportion|||Parameter: The difference in the frequency of any vulvar lesion of the Inner Vulvar Ring in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology.||||0.9753
72621040|NCT02732145|144773168|SUPERIORITY|Question: Is there a difference in the frequency of non-specific vulvar lesions among the patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||0.8986|||||||t-test proportion|||Parameter: The difference in the frequency of non-specific vulvar lesions in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology.||||0.8986
72461227|NCT01837719|144445278|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was concluded if the 90% CI for the ratios of geometric means of the test formulation (fixed-dose combination \[FDC\] tablet of 300/150 mg atazanavir/cobicistat) to the reference formulation (300-mg atazanavir capsule coadministered with 150-mg cobicistat) were contained within 0.80 to 1.25 for atazanavir Cmax, area under the plasma concentration-time curve from time 0 to time of last quantifiable concentration (AUC\[0-T\]) and AUC from time 0 to infinity. (AUC\[0-T\])|Geometric mean ratio|1.073|||||TWO_SIDED|90.0|1.012|1.137|||Mixed Models Analysis||Geometric mean ratio is calculated as Treatment B/Treatment A|To demonstrate bioequivalence for atazanavir between the test (Treatment B) and reference (Treatment A) formulations, a linear mixed-effects model was applied to the natural logarithms of atazanavir Cmax, with treatment, period, and sequence as fixed effects, and participant (sequence) as a random effect.||1.137|1.012|
72461228|NCT01837719|144445278|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.423|||||TWO_SIDED|90.0|1.273|1.59|||Mixed Models Analysis||Geometric mean ratio was calculated as Treatment B/Treatment D|A linear mixed-effect model with treatment as fixed effects and participant as a random effect will be used to estimate the effect of a light meal and the fasted state on the natural logarithms of exposure of atazanavir when given as an FDC||1.590|1.273|
72461229|NCT01837719|144445278|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.137|||||TWO_SIDED|90.0|1.0|1.292|||Mixed Models Analysis||Geometric mean ratio is calculated as Treatment D/Treatment C|To assess the relative bioavailability of atazanavir under fasted (Treatment D) versus fed (Treatment C) states, a linear mixed-effects model was applied to the natural logarithms of atazanavir Cmax with treatment, period, and sequence as fixed effects and participant (sequence) as a random effect.||1.292|1.000|
72461230|NCT01837719|144445278|SUPERIORITY_OR_OTHER||Geometric mean ratio|0.862|||||TWO_SIDED|90.0|0.701|1.059|||Mixed Models Analysis||Geometric mean ratio is calculated as Treatment E/Treatment D|A linear mixed-effect model with treatment as fixed effects and participant as a random effect will be used to estimate the effect of a high fat meal and the fasted state on the natural logarithms of exposure of atazanavir when given as an FDC||1.059|0.701|
72461231|NCT01837719|144445278|SUPERIORITY_OR_OTHER||Geometric mean ratio|0.643|||||TWO_SIDED|90.0|0.545|0.759|||Mixed Models Analysis||Geometric mean ratio is calculated as Treatment E/Treatment B|A linear mixed-effect model with treatment as fixed effects and participant as a random effect will be used to estimate the effect of high fat and light meals on the natural logarithms of exposure of atazanavir when given as an FDC||0.759|0.545|
72501516|NCT01642212|144532977|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-2.49||||0.2649|TWO_SIDED|95.0|-6.895|1.92||LS mean estimates were determined using the ANCOVA model including treatment group as a factor and baseline DSQ score as a covariate.|ANCOVA|||Analysis of Week 8||1.920|-6.895|0.2649
72501517|NCT01642212|144532977|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-2.91||||0.2878|TWO_SIDED|95.0|-8.322|2.501||LS mean estimates were determined using the ANCOVA model including treatment group as a factor and baseline DSQ score as a covariate.|ANCOVA|||Analysis of Week 12||2.501|-8.322|0.2878
72501518|NCT01642212|144532979|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0001|TWO_SIDED||||||Fisher Exact|||Analysis of \</= 15 Eosinophils/HPF||||0.0001
72501519|NCT01642212|144532979|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||Fisher Exact|||Analysis of \</= 1 Eosinophils/HPF||||<0.0001
72501520|NCT01642212|144532980|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0206|TWO_SIDED||||||Pearson's chi-square|||Analysis of \>/= 30% DSQ score reduction||||0.0206
72501521|NCT01642212|144532980|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0275|TWO_SIDED||||||Pearson's chi-square|||Analysis of \>/= 50% DSQ score reduction||||0.0275
72501522|NCT01642212|144532981|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0026|TWO_SIDED||||||Fisher Exact|||Analysis of response and \>/= 30% DSQ score reduction||||0.0026
72501523|NCT01642212|144532981|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0199|TWO_SIDED||||||Fisher Exact|||Analysis of response and \>/= 50% DSQ score reduction||||0.0199
72501524|NCT01642212|144532982|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-22.34|||<|0.0001|TWO_SIDED|95.0|-30.345|-14.334|||ANCOVA|LS mean based on the ANCOVA model including treatment group as a factor and baseline as a covariate.||||-14.334|-30.345|<0.0001
72501525|NCT01642212|144532983|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-3.76|||<|0.0001|TWO_SIDED|95.0|-5.172|-2.358||LS mean estimates based on the ANCOVA model including treatment group as a factor and baseline value as a covariate.|ANCOVA|||||-2.358|-5.172|<0.0001
72501526|NCT01642212|144532984|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-35.5||||0.0002|TWO_SIDED|95.0|-53.438|-17.57||LS mean estimates based on the ANCOVA model including treatment group as a factor and baseline value as a covariate.|ANCOVA|||Analysis of proximal eosinophil count||-17.570|-53.438|0.0002
72501527|NCT01642212|144532984|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-59.56|||<|0.0001|TWO_SIDED|95.0|-84.173|-34.948||LS mean estimates based on the ANCOVA model including treatment group as a factor and baseline value as a covariate.|ANCOVA|||Analysis of mid- eosinophil count||-34.948|-84.173|<0.0001
72461232|NCT01837719|144445279|NON_INFERIORITY_OR_EQUIVALENCE|To demonstrate bioequivalence for atazanavir between the test (Treatment B) and reference (Treatment A) formulations, a linear mixed-effects model was applied to the natural logarithms of atazanavir AUC(0-T), with treatment, period, and sequence as fixed effects, and participant (sequence) as a random effect.|Geometric mean ratio|1.065|||||TWO_SIDED|90.0|1.012|1.12|||Mixed Models Analysis||Geometric mean ratio for AUC(0-T) is calculated as Treatment B/Treatment A|Bioequivalence was concluded if the 90% confidence intervals for the ratios of geometric means of the test formulation (FDC tablet of 300/150 mg atazanavir/cobicistat) to the reference formulation (300-mg atazanavir capsule coadministered with 150-mg cobicistat) were contained within 0.80 to 1.25 for atazanavir Cmax, AUC(0-T) and AUC(INF).||1.120|1.012|
72461233|NCT01837719|144445279|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.275|||||TWO_SIDED|90.0|1.166|1.393|||Mixed Models Analysis||Geometric mean ratio for AUC(0-T) was calculated as Treatment B/Treatment D|A linear mixed-effect model with treatment as fixed effect and patient as a random effect was used to estimate the effect of a light meal and the fasted state on the natural logarithms of exposure of atazanavir when administered as an FDC||1.393|1.166|
72461234|NCT01837719|144445279|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.113|||||TWO_SIDED|90.0|0.993|1.248|||Mixed Models Analysis||Geometric mean ratio for AUC(0-T) is calculated as Treatment D/Treatment C|To assess the relative bioavailability of atazanavir under fasted (Treatment D) versus fed (Treatment C) states, a linear mixed-effects model was applied to the natural logarithms of atazanavir AUC(0-T) with treatment, period, and sequence as fixed effects and participant (sequence) as a random effect||1.248|0.993|
72461235|NCT01837719|144445279|SUPERIORITY_OR_OTHER||Geometric mean ratio|0.95|||||TWO_SIDED|90.0|0.804|1.122|||Mixed Models Analysis||Geometric mean ratio of AUC(0-T) was calculated as Treatment E/Treatment D|A linear mixed-effect model with treatment as fixed effect and participant as a random effect will be used to estimate the effect of a high fat meal and the fasted state on the natural logarithms of exposure of atazanavir when given as an FDC.||1.122|0.804|
72461236|NCT01837719|144445279|SUPERIORITY_OR_OTHER||Geometric mean ratio|0.746|||||TWO_SIDED|90.0|0.655|0.849|||Mixed Models Analysis||Geometric mean ratio of AUC(0-T) was calculated as Treatment E/Treatment B|A linear mixed-effect model with treatment as fixed effect and participant as a random effect will be used to estimate the effect of high fat and light meals on the natural logarithms of exposure of atazanavir when given as an FDC||0.849|0.655|
72461237|NCT01837719|144445279|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was concluded if the 90% confidence intervals for the ratios of geometric means of the test formulation (FDC tablet of 300/150 mg atazanavir/cobicistat) to the reference formulation (300-mg atazanavir capsule coadministered with 150-mg cobicistat) were contained within 0.80 to 1.25 for atazanavir Cmax, AUC(0-T) and AUC(INF).|Geometric mean ratio|1.064||||||90.0|1.011|1.12|||Mixed Models Analysis||Geometric mean ration for AUC(INF) is calculated as Treatment B/Treatment A|To demonstrate bioequivalence for atazanavir between the test (Treatment B) and reference (Treatment A) formulations, a linear mixed-effects model was applied to the natural logarithms of atazanavir AUC(0-INF), with treatment period and sequence as fixed effects, and patient (sequence) as a random effect.||1.120|1.011|
72461238|NCT01837719|144445279|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.28|||||TWO_SIDED|90.0|1.171|1.398|||Mixed Models Analysis||Geometric mean ratio for AUC(INF) was calculated as Treatment B/Treatment D|A linear mixed-effect model with treatment as fixed effect and participant as a random effect was used to estimate the effect of a light meal and fthe fasted state on the natural logarithms of exposure of atazanavir when given as an FDC||1.398|1.171|
72461239|NCT01837719|144445279|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.11|||||TWO_SIDED|90.0|0.991|1.244|||Mixed Models Analysis||Geometric mean ratio of AUC(INF) was calculated as Treatment D/Treatment C|To assess the relative bioavailability of atazanavir under fasted (Treatment D) versus fed (Treatment C) states, a linear mixed-effects model was applied to the natural logarithms of atazanavir AUC(0-INF) with treatment, period, and sequence as fixed effects and participant (sequence) as a random effect||1.244|0.991|
72501528|NCT01642212|144532984|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-67.38|||<|0.0001|TWO_SIDED|95.0|-93.573|-41.18||LS mean estimates based on the ANCOVA model including treatment group as a factor and baseline value as a covariate.|ANCOVA|||Analysis of distal eosinophil count||-41.180|-93.573|<0.0001
72501529|NCT01642212|144532985|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-18.44||||0.0015|TWO_SIDED|95.0|-29.593|-7.293||LS mean estimates were based on the ANCOVA model including treatment group as a factor and baseline value as a covariate.|ANCOVA|||||-7.293|-29.593|0.0015
72501530|NCT01642212|144532986|SUPERIORITY_OR_OTHER_LEGACY|||||||0.117|TWO_SIDED|||||P-value for comparison of the treatment difference was determined by Cochran-Mantel-Haenszel row mean score test.|Cochran-Mantel-Haenszel|||Analysis of distribution of scores across all responses||||0.1170
72501531|NCT01642212|144532987|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1947|TWO_SIDED|||||P-value for comparison of the treatment difference at baseline vs. final treatment evaluation was determined by a Cochran-Mantel-Haenszel row mean score test. All responses (improved, no change, worsened) were analyzed collectively for each symptom.|Cochran-Mantel-Haenszel|||Analysis of heartburn||||0.1947
72501532|NCT01642212|144532987|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8029|TWO_SIDED|||||P-value for comparison of the treatment difference at baseline vs. final treatment evaluation was determined by a Cochran-Mantel-Haenszel row mean score test. All responses (improved, no change, worsened) were analyzed collectively for each symptom.|Cochran-Mantel-Haenszel|||Analysis of chest pain||||0.8029
72501533|NCT01642212|144532987|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4963|TWO_SIDED|||||P-value for comparison of the treatment difference at baseline vs. final treatment evaluation was determined by a Cochran-Mantel-Haenszel row mean score test. All responses (improved, no change, worsened) were analyzed collectively for each symptom.|Cochran-Mantel-Haenszel|||Analysis of regurgitation||||0.4963
72501534|NCT01642212|144532987|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5257|TWO_SIDED|||||P-value for comparison of the treatment difference at baseline vs. final treatment evaluation was determined by a Cochran-Mantel-Haenszel row mean score test. All responses (improved, no change, worsened) were analyzed collectively for each symptom.|Cochran-Mantel-Haenszel|||Analysis of abdominal pain||||0.5257
72563492|NCT02413294|144658228|SUPERIORITY|||||||0.67|||||||Paired T test, 2-sided|||Pre-intervention period means are compared to intervention period means for all subjects.||||0.67
72563493|NCT02413294|144658229|SUPERIORITY|||||||0.56|||||||Paired T test, 2-sided|||Pre-intervention period means are compared to intervention period means for all subjects.||||0.56
72461240|NCT01837719|144445279|SUPERIORITY_OR_OTHER||Geometric mean ratio|0.956|||||TWO_SIDED|90.0|0.81|1.128|||Mixed Models Analysis||Geometric mean of AUC(INF) was calculated as Treatment E/Treatment D|||1.128|0.810|
72461241|NCT01837719|144445279|SUPERIORITY_OR_OTHER||Geometric mean ratio|0.749|||||TWO_SIDED|90.0|0.658|0.852|||Mixed Models Analysis||Geometric mean ratio of AUC(INF) was calculated as Treatment E/Treatment B|A linear mixed-effect model with treatment as fixed effect and participant as a random effect was used to estimate the effect of high fat and light meals on the natural logarithms of exposure of atazanavir when administered as an FDC.||0.852|0.658|
72461242|NCT01837719|144445284|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.084|||||TWO_SIDED|90.0|1.014|1.158|||Mixed Models Analysis||Geometric mean ratio was calculated as Treatment B/Treatment A|A linear mixed-effect model with treatment as fixed effect and patient as random effect will be used to estimate the effect of a light meal and the fasted state on the natural logarithms of exposure of atazanavir when administered as a fixed-dose combination.||1.158|1.014|
72461243|NCT01837719|144445284|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.349|||||TWO_SIDED|90.0|1.215|1.498|||Mixed Models Analysis||Geometric mean ratio of C24 was calculated as Treatment B/Treatment D|A linear mixed-effect model with treatment as fixed effect and patient as random effect will be used to estimate the effect of a light meal and the fasted state on the natural logarithms of exposure of atazanavir when administered as a fixed-dose combination.||1.498|1.215|
72461244|NCT01837719|144445284|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.144||||||90.0|1.006|1.3|||Mixed Models Analysis||Geometric mean ratio was calculated as Treatment D/Treatment C|A linear mixed-effect model with treatment as fixed effect and patient as random effect will be used to estimate the effect of a light meal and the fasted state on the natural logarithms of exposure of atazanavir when administered as an FDC||1.300|1.006|
72461245|NCT01837719|144445284|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.231|||||TWO_SIDED|90.0|1.023|1.483|||||Geometric mean ratio was calculated as Treatment E/Treatment D|A linear mixed-effect model with treatment as fixed effect and patient as random effect will be used to estimate the effect of a light meal and the fasted state on the natural logarithms of exposure of atazanavir when administered as a fixed-dose combination.||1.483|1.023|
72461246|NCT01837719|144445284|SUPERIORITY_OR_OTHER||Geometric mean ratio|0.912||||||90.0|0.789|1.054|||Mixed Models Analysis||Geometric mean ratio was calculated as Treatment E/Treatment B|A linear mixed-effect model with treatment as fixed effect and patient as random effect will be used to estimate the effect of a light meal and the fasted state on the natural logarithms of exposure of atazanavir when administered as a fixed-dose combination.||1.054|0.789|
72461247|NCT01837719|144445286|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.023|||||TWO_SIDED|90.0|0.991|1.057|||||Geometric mean ratio was calculated as Treatment B/Treatment A|A linear mixed-effect model with treatment as fixed effect and patient as random effect will be used to estimate the effect of a light meal and the fasted state on the natural logarithms of exposure of cobicistat when administered as a fixed-dose combination.||1.057|0.991|
72461248|NCT01837719|144445286|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.305|||||TWO_SIDED|90.0|1.215|1.402|||Mixed Models Analysis||Geometric mean ratio was calculated as Treatment B/Treatment D|A linear mixed-effect model with treatment as fixed effect and patient as random effect will be used to estimate the effect of a light meal and the fasted state on the natural logarithms of exposure of cobicistat when administered as a fixed-dose combination.||1.402|1.215|
72461249|NCT01837719|144445286|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.085|||||TWO_SIDED|90.0|0.925|1.273|||||Geometric mean ratio was calculated as Treatment D/Treatment C|A linear mixed-effect model with treatment as fixed effect and patient as random effect will be used to estimate the effect of a light meal and the fasted state on the natural logarithms of exposure of atazanavir cobicistat||1.273|0.925|
72461250|NCT01837719|144445286|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.04|||||TWO_SIDED|90.0|0.937|1.154|||||Geometric mean ratio was calculated asTreatment E/Treatment D|A linear mixed-effect model with treatment as fixed effect and patient as random effect will be used to estimate the effect of a light meal and the fasted state on the natural logarithms of exposure of cobicistat when administered as a fixed-dose combination.||1.154|0.937|
72461251|NCT01837719|144445286|SUPERIORITY_OR_OTHER||Geometric mean ratio|0.784|||||TWO_SIDED|90.0|0.717|0.858|||Mixed Models Analysis||Geometric mean ratio was calculated as Treatment E/Treatment B|A linear mixed-effect model with treatment as fixed effect and patient as random effect will be used to estimate the effect of a light meal and the fasted state on the natural logarithms of exposure of cobicistat when administered as a fixed-dose combination.||0.858|0.717|
72461252|NCT01837719|144445288|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.019|||||TWO_SIDED|90.0|0.983|1.057|||||Geometric mean ratio of AUC(0-T) was calculated as Treatment B/Treatment A|A linear mixed-effect model was applied to the natural logarithms of cobicistat AUC(0-T) with treatment, period, and sequence as fixed effects and participant (sequence) as a random effect.||1.057|0.983|
72461253|NCT01837719|144445288|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.232||||||90.0|1.141|1.331|||||Geometric mean ratio of AUC(0-T) was calculated as Treatment B/Treatment D|A linear mixed-effect model with treatment as fixed effects and participant as a random effect will be used to estimate the effect of a light meal and the fasted state on the natural logarithms of exposure of cobicistat when given as an FDC||1.331|1.141|
72563494|NCT02413294|144658230|SUPERIORITY|||||||0.82|||||||Paired T test, 2-sided|||Pre-intervention period means are compared to intervention period means for all subjects.||||0.82
72461254|NCT01837719|144445288|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.102|||||TWO_SIDED|90.0|0.929|1.307|||||Geometric mean ratio of AUC(0-T) was calculated as Treatment D/Treatment C|A linear mixed-effect model was applied to the natural logarithms of cobicistat AUC(0-T) with treatment, period, and sequence as fixed effects and participant (sequence) as a random effect.||1.307|0.929|
72461255|NCT01837719|144445288|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.127||||||90.0|1.017|1.248|||||Geometric mean ratio of AUC(0-T) was calculated asTreatment E/Treatment D|A linear mixed-effect model with treatment as fixed effects and participant as a random effect will be used to estimate the effect of a high fat meal and the fasted state on the natural logarithms of exposure of cobicistat when given as an FDC.||1.248|1.017|
72461256|NCT01837719|144445288|SUPERIORITY_OR_OTHER||Geometric mean ratio|0.89|||||TWO_SIDED|90.0|0.825|0.96|||||Geometric mean ratio of AUC(0-T) was calculated asTreatment E/Treatment B|A linear mixed-effect model with treatment as fixed effects and participant as a random effect will be used to estimate the effect of a high fat meal and a light meal on the natural logarithms of exposure of cobicistat when given as an FDC||0.960|0.825|
72392794|NCT00056316|144293147|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.93||||0.05||95.0|||||t-test, 2 sided||Mean difference is equal to Behavioral Skills Intervention minus Basic Education Control|||||.05
72392795|NCT00056316|144293148|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.07||||0.05||95.0|||||t-test, 2 sided||Mean difference is equal to Behavioral Skills Intervention minus Basic Education Control|||||.05
72392796|NCT02990910|144293153|SUPERIORITY||||||<|0.05|||||||Chi-squared|||Chi square test was used to compare the count data,p \< 0.05 was considered statistically significant.||||<0.05
72392797|NCT00583778|144293157|SUPERIORITY||Median Difference (Final Values)|12.0|STANDARD_DEVIATION|25.0|<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Data were analyzed using STATA 10 SE.Categorical variables were described using frequencies and relative frequencies. Distribution of continuous variables were evaluated for normality using the Shapiro-Walk test and graphically using histograms and box plots. Because most data were non-parametric, they were described using the median and 25th and 75th percentiles (interquartile range) and then compared using Wilcoxon rank sum test.|This study was designed to detect an absolute difference of 12 % in change of FEV-1percent predicted, with a standard deviation of 25% based on data provided to us from previous studies conducted by Sepracor. Based on this assumption, we sought to enter 76 patients in each group to have an 80% power to detect a 12 % absolute difference in charge of FEV-1 percent predicted over time at an alpha of 0.05. This accounted for a potential 10% dropout rate after randomization.|||< 0.05
72501535|NCT01642212|144532987|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5219|TWO_SIDED|||||P-value for comparison of the treatment difference at baseline vs. final treatment evaluation was determined by a Cochran-Mantel-Haenszel row mean score test. All responses (improved, no change, worsened) were analyzed collectively for each symptom.|Cochran-Mantel-Haenszel|||Analysis of nausea||||0.5219
72501536|NCT01642212|144532987|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2886|TWO_SIDED|||||P-value for comparison of the treatment difference at baseline vs. final treatment evaluation was determined by a Cochran-Mantel-Haenszel row mean score test. All responses (improved, no change, worsened) were analyzed collectively for each symptom.|Cochran-Mantel-Haenszel|||Analysis of vomiting||||0.2886
72501537|NCT01642212|144532990|SUPERIORITY_OR_OTHER_LEGACY|||||||0.16|TWO_SIDED|||||P-value for comparison of the treatment difference at baseline vs. final treatment evaluation was determined by a Cochran-Mantel-Haenszel row mean score test. Both responses (no change, worsened) were analyzed collectively.|Cochran-Mantel-Haenszel|||Analysis of symptoms of participants with no symptoms at baseline||||0.1600
72501538|NCT01642212|144532992|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0606|TWO_SIDED||||||Pearson's chi-square|||Analysis of \>/= 30% DSQ+pain score reduction||||0.0606
72501539|NCT01642212|144532992|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0165|TWO_SIDED||||||Pearson's chi-square|||Analysis of \>/= 50% DSQ+pain score reduction||||0.0165
72501540|NCT01642212|144532993|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7817|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.7817
72501541|NCT01642212|144532994|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.09||||0.1686|TWO_SIDED|95.0|-0.222|0.04||Estimates are determined using an ANCOVA model including treatment group as a factor and baseline DSQ score as a covariate.|ANCOVA|||Analysis of Week 8||0.040|-0.222|0.1686
72501542|NCT01642212|144532994|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.03||||0.8046|TWO_SIDED|95.0|-0.269|0.21||Estimates are determined using an ANCOVA model including treatment group as a factor and baseline DSQ score as a covariate.|ANCOVA|||Analysis of Week 12||0.210|-0.269|0.8046
72501543|NCT01642212|144532994|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.01||||0.9239|TWO_SIDED|95.0|-0.199|0.219||Estimates are determined using an ANCOVA model including treatment group as a factor and baseline DSQ score as a covariate.|ANCOVA|||Analysis of Week 16||0.219|-0.199|0.9239
72501544|NCT01642212|144532995|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.73||||0.4835|TWO_SIDED|95.0|-2.806|1.339||Estimates are determined using an ANCOVA model including treatment group as a factor and baseline DSQ score as a covariate.|ANCOVA|||Analysis of Week 8||1.339|-2.806|0.4835
72501545|NCT01642212|144532995|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.92||||0.0662|TWO_SIDED|95.0|-3.974|0.132||Estimates are determined using an ANCOVA model including treatment group as a factor and baseline DSQ score as a covariate.|ANCOVA|||Analysis of Week 12||0.132|-3.974|0.0662
72501546|NCT01642212|144532995|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.8||||0.1091|TWO_SIDED|95.0|-4.006|0.41||Estimates are determined using an ANCOVA model including treatment group as a factor and baseline DSQ score as a covariate.|ANCOVA|||Analysis of Week 16||0.410|-4.006|0.1091
72501547|NCT00004980|144533003|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.76|STANDARD_ERROR_OF_MEAN|0.514||0.005||95.0|-4.65|-0.86||a priori threshold for statistical significance was .05|t-test, 2 sided|degree of freedom = 48||||-.86|-4.65|.005
72501548|NCT00004980|144533004|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.27|STANDARD_ERROR_OF_MEAN|0.327||0.002||95.0|0.507|2.03||a priori threshold for statistical significance was .05|t-test, 2 sided|degrees of freedom = 48||null hypothesis is that the groups are the same||2.03|.507|.002
72501549|NCT00004980|144533005|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.949|STANDARD_ERROR_OF_MEAN|0.524||0.001||95.0|-1.45|-0.44||A priori threshold for statistical significance was .05|t-test, 2 sided|degrees of freedom = 46||||-.44|-1.45|.001
72501550|NCT00004980|144533006|SUPERIORITY_OR_OTHER|||||||0.01||95.0||||a priori threshold for statistical significance = .05|Chi-squared|||||||.01
72501551|NCT00702143|144533007|SUPERIORITY_OR_OTHER|||||||0.0002||95.0|||||Fisher Exact|||Fisher exact test comparing the proportion of amyloid positive subjects between clinical diagnosis groups||||0.0002
72501552|NCT00702143|144533007|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Fisher Exact|||Fisher exact test comparing the proportion of amyloid positive subjects between clinical diagnosis groups||||<0.0001
72501553|NCT00702143|144533007|SUPERIORITY_OR_OTHER|||||||0.0014||95.0|||||Fisher Exact|||Fisher exact test comparing the proportion of amyloid positive subjects between clinical diagnosis groups||||0.0014
72501554|NCT00702143|144533009|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANOVA|||Analysis of variance P value testing for an overall difference in the mean cortical SUVR between the clinical diagnostic groups.||||<0.0001
72501555|NCT00702143|144533009|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANOVA|||Analysis of variance contrast P value testing for difference in the mean cortical SUVR||||<0.0001
72501556|NCT00702143|144533009|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANOVA|||Analysis of variance contrast P value testing for difference in the mean cortical SUVR||||<0.0001
72501557|NCT00702143|144533009|SUPERIORITY_OR_OTHER|||||||0.0003||95.0|||||ANOVA|||Analysis of variance contrast P value testing for difference in the mean cortical SUVR||||0.0003
72501558|NCT03577990|144533011|SUPERIORITY|Our sample (N = 90) had approximately 80% power (assuming 5 dropouts per arm) to detect an effect size of ∼.205 or greater at the α = .05 level of statistical significance, given a realistic range of simulated unstructured covariance matrices. An 11% rate of attrition was anticipated to yield a final sample of 80 participants, an average of 40 per arm. Participants who dropped out of the study prior to receiving the allotted intervention were not included in the analysis.|Mean Difference (Final Values)|0.125||||0.05|TWO_SIDED|||||P-values were computed according to a mixed-effects repeated measures model, appropriately constrained to baseline if indicated.|mixed-effects repeated measures||||For both referent (compared by month and treatment group) and constrained longitudinal data analysis (cLDA) models, p-values were computed for the main group (G), time (T), and interaction (G x T) effects. For the first 3 months of the referent arm (IT), data were compared with usual care. Consequently, months 1 - 6 in the statistical analysis corresponds to calendar months 4 - 9 of the data collection. Months 1 - 9 of the intervention arm (ITEC) reflects months 1 - 9 of the collection. Additionally, for the cLDA model, data in the referent arm (IT) were accordingly shifted such that the starting point on the y-axis for both arms were the same (i.e. y = 0).|||.05
72563495|NCT01631682|144658231|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||This study used a within-groups design. Each subject provides his/her own comparison data. It was predicted that that a conditioned stimulus that was reactivated (CS+R) after propranolol was administered would result in a smaller SCR than a conditioned stimulus that was not reactivated (CS+N).||||>.05
72501559|NCT03577990|144533012|SUPERIORITY|Our sample (N = 90) had approximately 80% power (assuming 5 dropouts per arm) to detect an effect size of ∼.205 or greater at the α = .05 level of statistical significance, given a realistic range of simulated unstructured covariance matrices. An 11% rate of attrition was anticipated to yield a final sample of 80 participants, an average of 40 per arm. Participants who dropped out of the study prior to receiving the allotted intervention were not included in the analysis.|Mean Difference (Final Values)|1250.0||||0.05|TWO_SIDED|||||P-values were computed according to a mixed-effects repeated measures model, appropriately constrained to baseline if indicated.|mixed-effects repeated measures||||For both referent (compared by month and treatment group) and constrained longitudinal data analysis (cLDA) models, p-values were computed for the main group (G), time (T), and interaction (G x T) effects. For the first 3 months of the referent arm (IT), data were compared with usual care. Consequently, months 1 - 6 in the statistical analysis corresponds to calendar months 4 - 9 of the data collection. Months 1 - 9 of the intervention arm (ITEC) reflects months 1 - 9 of the collection. Additionally, for the cLDA model, data in the referent arm (IT) were accordingly shifted such that the starting point on the y-axis for both arms were the same (i.e. y = 0).|||.05
72501560|NCT03577990|144533013|SUPERIORITY|Our sample (N = 90) had approximately 80% power (assuming 5 dropouts per arm) to detect an effect size of ∼.205 or greater at the α = .05 level of statistical significance, given a realistic range of simulated unstructured covariance matrices. An 11% rate of attrition was anticipated to yield a final sample of 80 participants, an average of 40 per arm. Participants who dropped out of the study prior to receiving the allotted intervention were not included in the analysis.|Mean Difference (Final Values)|300.0||||0.05|TWO_SIDED|||||P-values were computed according to a mixed-effects repeated measures model, appropriately constrained to baseline if indicated.|mixed-effects repeated measures||||For both referent (compared by month and treatment group) and constrained longitudinal data analysis (cLDA) models, p-values were computed for the main group (G), time (T), and interaction (G x T) effects. For the first 3 months of the referent arm (IT), data were compared with usual care. Consequently, months 1 - 6 in the statistical analysis corresponds to calendar months 4 - 9 of the data collection. Months 1 - 9 of the intervention arm (ITEC) reflects months 1 - 9 of the collection. Additionally, for the cLDA model, data in the referent arm (IT) were accordingly shifted such that the starting point on the y-axis for both arms were the same (i.e. y = 0).|||.05
72504812|NCT03114969|144540516|SUPERIORITY||Odds Ratio (OR)|5.93||||0.002|TWO_SIDED|95.0|1.89|18.611||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Incruse/Anoro Ellipta as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.|||18.611|1.890|0.002
72563496|NCT01631682|144658231|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||This study used a within-groups design. Each subject provides his/her own comparison data. It was predicted that that a conditioned stimulus that was initially presented (CS+R) and then followed by a series of extinction trials after a 10-min delay would result in a smaller SCR than a conditioned stimulus (CS+N) that was not extinguished without a 10-min delay.||||>.05
72563497|NCT01631682|144658231|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||This study used a within-groups design. Each subject provides his/her own comparison data. It was predicted that that a conditioned stimulus that was reactivated (CS+R) after mifepristone was administered would result in a smaller SCR than a conditioned stimulus that was not reactivated (CS+N).||||<.05
72563498|NCT01631682|144658231|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||This study used a within-groups design. Each subject provides his/her own comparison data. It was predicted that that a conditioned stimulus that was reactivated (CS+R) after intranasal oxytocin was administered would result in a smaller SCR than a conditioned stimulus that was not reactivated (CS+N).||||>.05
72563499|NCT00831233|144658263|NON_INFERIORITY_OR_EQUIVALENCE|"The trial was positive if the treatment contrast of degarelix versus goserelin plus bicalutamide in adjusted (for baseline total IPSS, age, and country) mean change from baseline in total IPSS was statistically significantly smaller (two-sided at α=0.05 level) than Δ=3 points in both the FAS and the PP analysis set.~If the Week 12 treatment assessment of IPSS was missing the LOCF approach was used, i.e., the IPSS closest to and before Week 12 was used."|Mean Difference (Final Values)|-2.95||||0.1973|TWO_SIDED|95.0|-7.51|1.61||FAS.|ANCOVA|The baseline score, age, and country were used as covariates and treatment was used as a factor in the analysis.||Estimates from analysis of variance with treatment and country as factors and age and baseline value as covariates.||1.61|-7.51|0.1973
72563500|NCT00831233|144658263|NON_INFERIORITY_OR_EQUIVALENCE|"The trial was positive if the treatment contrast of degarelix versus goserelin plus bicalutamide in adjusted (for baseline total IPSS, age, and country) mean change from baseline in total IPSS was statistically significantly smaller (two-sided at α=0.05 level) than Δ=3 points in both the FAS and the PP analysis set.~If the Week 12 treatment assessment of IPSS was missing the LOCF approach was used, i.e., the IPSS closest to and before Week 12 was used."|Mean Difference (Final Values)|-5.88||||0.0398|TWO_SIDED|95.0|-11.5|-0.291||PP analysis set.|ANCOVA|The baseline score, age, and country were used as covariates and treatment was used as a factor in the analysis.||Estimates from analysis of variance with treatment and country as factors and age and baseline value as covariates.||-0.291|-11.5|0.0398
72563501|NCT00831233|144658264|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.47||||0.2298|TWO_SIDED|95.0|-6.58|1.64|||ANCOVA|The baseline score, age, and country were used as covariates and treatment was used as a factor in the analysis for the FAS.||Week 4. Estimates from analysis of variance with treatment and country as factors and age and baseline value as covariates.||1.64|-6.58|0.2298
72392798|NCT00309387|144293160|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.82||||0.03|TWO_SIDED|95.0|0.68|0.98|||Regression, Cox|||||0.98|0.68|0.03
72392799|NCT02483520|144293167|SUPERIORITY||LSM Estimate|0.03||||0.977|TWO_SIDED|95.0|-2.02|2.08|||Mixed Models Analysis|||Linear mixed models were fitted to changes in outcomes with SAS Procedure Mixed. Efficacy of the FamTechCare intervention versus attention control was expressed as the model-estimated difference between the groups on mean change from baseline to 3 months. Burden, Depression, Sleep disturbance, Competence, Desire to institutionalize, Reaction to memory symptoms, Reaction to depression symptoms, Reaction to disruptive symptoms were included in the model.||2.08|-2.02|.977
72392800|NCT02483520|144293168|SUPERIORITY||LSM Estimate|-0.22||||0.812|TWO_SIDED|95.0|-2.09|1.64|||Mixed Models Analysis|||Linear mixed models were fitted to changes in outcomes with SAS Procedure Mixed. Efficacy of the FamTechCare intervention versus attention control was expressed as the model-estimated difference between the groups on mean change from baseline to 3 months. Burden, Depression, Sleep disturbance, Competence, Desire to institutionalize, Reaction to memory symptoms, Reaction to depression symptoms, Reaction to disruptive symptoms were included in the model.||1.64|-2.09|.812
72461257|NCT01837719|144445288|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was concluded if the 90% CI for the ratios of geometric means of the test formulation (FDC tablet of 300/150 mg atazanavir/cobicistat) to the reference formulation (300-mg atazanavir capsule coadministered with 150-mg cobicistat) were contained within 0.80 to 1.25 for atazanavir Cmax, AUC(0-T), and AUC(INF).|Geometric mean ratio|1.019|||||TWO_SIDED|90.0|0.982|1.058|||||Geometric mean ratio of AUC(INF) was calculated as Treatment B/Treatment A|To demonstrate bioequivalence for atazanavir between the test (Treatment B) and reference (Treatment A) formulations, a linear mixed-effects model was applied to the natural logarithms of atazanavir AUC(0-INF), with treatment, period, and sequence as fixed effects, and participant (sequence) as a random effect.||1.058|0.982|
72563502|NCT00831233|144658264|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.983||||0.6917|TWO_SIDED|95.0|-5.98|4.02|||ANCOVA|The baseline score, age, and country were used as covariates and treatment was used as a factor in the analysis for the FAS.||Week 8. Estimates from analysis of variance with treatment and country as factors and age and baseline value as covariates.||4.02|-5.98|0.6917
72563503|NCT00831233|144658265|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.553||||0.8151|TWO_SIDED|95.0|-5.33|4.22|||ANCOVA|The baseline score, age, and country were used as covariates and treatment was used as a factor in the analysis for the FAS.||Week 4. Estimates from analysis of variance with treatment and country as factors and age and baseline value as covariates.||4.22|-5.33|0.8151
72563504|NCT00831233|144658265|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.46||||0.455|TWO_SIDED|95.0|-2.46|5.38|||ANCOVA|The baseline score, age, and country were used as covariates and treatment was used as a factor in the analysis for the FAS.||Week 8. Estimates from analysis of variance with treatment and country as factors and age and baseline value as covariates.||5.38|-2.46|0.455
72563505|NCT00831233|144658265|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.02||||0.3186|TWO_SIDED|95.0|-2.04|6.08|||ANCOVA|The baseline score, age, and country were used as covariates and treatment was used as a factor in the analysis for the FAS.||Week 12. Estimates from analysis of variance with treatment and country as factors and age and baseline value as covariates.||6.08|-2.04|0.3186
72501561|NCT03577990|144533015|SUPERIORITY|Our sample (N = 90) had approximately 80% power (assuming 5 dropouts per arm) to detect an effect size of ∼.205 or greater at the α = .05 level of statistical significance, given a realistic range of simulated unstructured covariance matrices. An 11% rate of attrition was anticipated to yield a final sample of 80 participants, an average of 40 per arm. Participants who dropped out of the study prior to receiving the allotted intervention were not included in the analysis.|Mean Difference (Final Values)|500.0||||0.05|TWO_SIDED|||||P-values were computed according to a mixed-effects repeated measures model, appropriately constrained to baseline if indicated.|mixed-effects repeated measures||||For both referent (compared by month and treatment group) and constrained longitudinal data analysis (cLDA) models, p-values were computed for the main group (G), time (T), and interaction (G x T) effects. For the first 3 months of the referent arm (IT), data were compared with usual care. Consequently, months 1 - 6 in the statistical analysis corresponds to calendar months 4 - 9 of the data collection. Months 1 - 9 of the intervention arm (ITEC) reflects months 1 - 9 of the collection. Additionally, for the cLDA model, data in the referent arm (IT) were accordingly shifted such that the starting point on the y-axis for both arms were the same (i.e. y = 0).|||.05
72501562|NCT04996797|144533031|SUPERIORITY||Risk Difference (RD)|25.0|||<|0.0001|TWO_SIDED|95.0|11.8|36.5|||Cochran-Mantel-Haenszel|P-value is computed using Cochran-Mantel Haenszel (CMH) test with stratification factors of biologic status and CDx status.|95% CI is estimated using Newcombe method for risk difference.|||36.5|11.8|<.0001
72501563|NCT04996797|144533034|SUPERIORITY||Risk Difference (RD)|30.8|||<|0.0001|TWO_SIDED|95.0|17.4|43.2|||Cochran-Mantel-Haenszel|P-value is computed using Cochran-Mantel Haenszel (CMH) test with stratification factors of biologic status and CDx status.|95% CI is estimated using Newcombe method for risk difference.|||43.2|17.4|<0.0001
72501564|NCT04996797|144533035|SUPERIORITY||Risk Difference (RD)|43.8|||<|0.0001|TWO_SIDED|95.0|27.4|56.9|||Cochran-Mantel-Haenszel|P-value is computed using Cochran-Mantel Haenszel (CMH) test with stratification factors of biologic status and CDx status.|95% CI is estimated using Newcombe method for risk difference.|||56.9|27.4|<.0001
72501565|NCT04996797|144533036|SUPERIORITY||Risk Difference (RD)|20.8||||0.0224||95.0|2.1|37.9|||Cochran-Mantel-Haenszel|P-value is computed using Cochran-Mantel Haenszel (CMH) test with stratification factor of biologic status.|95% CI is estimated using Newcombe method for risk difference.|||37.9|2.1|0.0224
72501566|NCT04996797|144533037|SUPERIORITY||Risk Difference (RD)|13.1||||0.0223||95.0|1.8|24.6|||Cochran-Mantel-Haenszel|P-value is computed using Cochran-Mantel Haenszel (CMH) test with stratification factors of biologic status and CDx status.|95% CI is estimated using Newcombe method for risk difference.|||24.6|1.8|0.0223
72501567|NCT04996797|144533038|SUPERIORITY||Risk Difference (RD)|28.6||||0.0009||95.0|12.1|42.9|||Cochran-Mantel-Haenszel|P-value is computed using Cochran-Mantel Haenszel (CMH) test with stratification factors of biologic status and CDx status.|95% CI is estimated using Newcombe method for risk difference.|||42.9|12.1|0.0009
72501568|NCT04996797|144533039|SUPERIORITY||Risk Difference (RD)|27.3|||<|0.0001||95.0|14.3|39.6|||Cochran-Mantel-Haenszel|P-value is computed using Cochran-Mantel Haenszel (CMH) test with stratification factors of biologic status and CDx status.|95% CI is estimated using Newcombe method for risk difference.|||39.6|14.3|<0.0001
72621041|NCT02732145|144773168|SUPERIORITY|Question: Is there a difference in the frequency of specific vulvar lesions among the patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology (first biopsy)?||||||0.0017|||||||t-test proportion|||Parameter: The difference in the frequency of vulvar lesions specific for dermatosis in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology (first biopsy).||||0.0017
72501569|NCT04996797|144533040|SUPERIORITY||Risk Difference (RD)|17.9||||||95.0|-2.4|36.4|||||95% CI is estimated using Newcombe method for risk difference.|||36.4|-2.4|
72501570|NCT04996797|144533041|SUPERIORITY||Risk Difference (RD)|22.8||||||95.0|0.4|42.2|||||95% CI is estimated using Newcombe method for risk difference.|||42.2|0.4|
72501571|NCT04996797|144533042|SUPERIORITY||Risk Difference (RD)|10.2||||||95.0|-6.9|26.9|||||95% CI is estimated using Newcombe method for risk difference.|||26.9|-6.9|
72501572|NCT04996797|144533043|SUPERIORITY||Risk Difference (RD)|28.9||||||95.0|5.0|48.3|||||95% CI is estimated using Newcombe method for risk difference.|||48.3|5.0|
72501573|NCT04996797|144533044|SUPERIORITY||Risk Difference (RD)|22.2|||||TWO_SIDED|95.0|0.2|41.0|||||95% CI is estimated using Newcombe method for risk difference.|||41.0|0.2|
72501574|NCT04996797|144533045|SUPERIORITY||Risk Difference (RD)|27.3|||<|0.0001|TWO_SIDED|95.0|14.3|39.6|||Cochran-Mantel-Haenszel|P-value is computed using Cochran-Mantel Haenszel (CMH) test with stratification factors of biologic status and CDx status.|95% CI is estimated using Newcombe method for risk difference.|||39.6|14.3|<0.0001
72501575|NCT04996797|144533046|SUPERIORITY||Risk Difference (RD)|22.2||||||95.0|0.2|41.0|||||95% CI is estimated using Newcombe method for risk difference.|||41.0|0.2|
72563506|NCT00831233|144658266|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|15.2||||0.5627|TWO_SIDED|95.0|-37.8|68.2|||ANCOVA|The baseline score, age, and country were used as covariates and treatment was used as a factor in the analysis for the FAS.||Week 4. Estimates from analysis of variance with treatment and country as factors and age and baseline value as covariates.||68.2|-37.8|0.5627
72563507|NCT00831233|144658266|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.91||||0.8284|TWO_SIDED|95.0|-49.1|60.9|||ANCOVA|The baseline score, age, and country were used as covariates and treatment was used as a factor in the analysis for the FAS.||Week 8. Estimates from analysis of variance with treatment and country as factors and age and baseline value as covariates.||60.9|-49.1|0.8284
72563508|NCT00831233|144658266|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.2||||0.5984|TWO_SIDED|95.0|-34.4|58.8|||ANCOVA|The baseline score, age, and country were used as covariates and treatment was used as a factor in the analysis for the FAS.||Week 12. Estimates from analysis of variance with treatment and country as factors and age and baseline value as covariates.||58.8|-34.4|0.5984
72563509|NCT00831233|144658267|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.83||||0.1018|TWO_SIDED|95.0|-17.3|1.64|||ANCOVA|The baseline score, age, and country were used as covariates and treatment was used as a factor in the analysis for the FAS.||Estimates from analysis of variance with treatment and country as factors and age and baseline value as covariates.||1.64|-17.3|0.1018
72621042|NCT02732145|144773169|EQUIVALENCE|Question: Is there a difference in the score for vulvar complaints (mean) among the patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||1|||||||Wilcoxon (Mann-Whitney)|||Parameter: The difference in the score for vulvar complaints (mean) in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology.||||1.0000
72392801|NCT02483520|144293171|SUPERIORITY||LSM Estimate|-1.5||||0.343|TWO_SIDED|95.0|-4.64|1.64|||Mixed Models Analysis|||Linear mixed models were fitted to changes in outcomes with SAS Procedure Mixed. Efficacy of the FamTechCare intervention versus attention control was expressed as the model-estimated difference between the groups on mean change from baseline to 3 months. Burden, Depression, Sleep disturbance, Competence, Desire to institutionalize, Reaction to memory symptoms, Reaction to depression symptoms, Reaction to disruptive symptoms were included in the model.||1.64|-4.64|.343
72392802|NCT02483520|144293172|SUPERIORITY||LSM Estimate|-4.79||||0.012|TWO_SIDED|95.0|-8.51|-1.08|||Mixed Models Analysis|||Linear mixed models were fitted to changes in outcomes with SAS Procedure Mixed. Efficacy of the FamTechCare intervention versus attention control was expressed as the model-estimated difference between the groups on mean change from baseline to 3 months. Burden, Depression, Sleep disturbance, Competence, Desire to institutionalize, Reaction to memory symptoms, Reaction to depression symptoms, Reaction to disruptive symptoms were included in the model.||-1.08|-8.51|.012
72392803|NCT02483520|144293173|SUPERIORITY||LSM Estimate|0.77||||0.033|TWO_SIDED|95.0|0.07|1.47|||Mixed Models Analysis|||Linear mixed models were fitted to changes in outcomes with SAS Procedure Mixed. Efficacy of the FamTechCare intervention versus attention control was expressed as the model-estimated difference between the groups on mean change from baseline to 3 months. Burden, Depression, Sleep disturbance, Competence, Desire to institutionalize, Reaction to memory symptoms, Reaction to depression symptoms, Reaction to disruptive symptoms were included in the model.||1.47|0.07|.033
72392804|NCT02483520|144293176|SUPERIORITY|||||||0.211|||||||Wilcoxon (Mann-Whitney)|||p-values were calculated for differences between mean group changes using Wilcoxon rank-sum test at 3 months||||.211
72392805|NCT02483520|144293176|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||p-values were calculated for within- group changes using Wilcoxon signed-rank test between baseline and 3 months||||<.001
72392806|NCT02483520|144293177|SUPERIORITY|||||||0.476|||||||Wilcoxon (Mann-Whitney)|||p-values were calculated for differences between mean group changes using Wilcoxon rank-sum test at 3 months||||.476
72461258|NCT01837719|144445288|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.24|||||TWO_SIDED|90.0|1.148|1.34|||||Geometric mean ratio of AUC(INF) was calculated as Treatment B/Treatment D|A linear mixed-effect model with treatment as fixed effects and participant as a random effect will be used to estimate the effect of a light meal and the fasted state on the natural logarithms of exposure of cobicistat when given as an FDC||1.340|1.148|
72461259|NCT01837719|144445288|SUPERIORITY_OR_OTHER||Geometric mean ratio|0.976|||||TWO_SIDED|90.0|0.886|1.075|||||Geometric mean ratio of AUC(INF) was calculated as Treatment D/Treatment C|A linear mixed-effect model was applied to the natural logarithms of cobicistat AUC(INF) with treatment, period, and sequence as fixed effects and participant (sequence) as a random effect.||1.075|0.886|
72461260|NCT01837719|144445288|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.116|||||TWO_SIDED|90.0|1.012|1.231|||||Geometric mean ratio of AUC(INF) was calculated as Treatment E/Treatment D|A linear mixed-effect model with treatment as fixed effects and participant as a random effect will be used to estimate the effect of a high fat meal and fasted on the natural logarithms of exposure of cobicistat when given as an FDC.||1.231|1.012|
72461261|NCT01837719|144445288|SUPERIORITY_OR_OTHER||Geometric mean ratio|0.904|||||TWO_SIDED|90.0|0.836|0.978|||||Geometric mean ratio of AUC(INF) was calculated as Treatment E/Treatment B|A linear mixed-effect model with treatment as fixed effects and participant as a random effect will be used to estimate the effect of a high fat meal and light meal on the natural logarithms of exposure of atazanavir when given as an FDC||0.978|0.836|
72461262|NCT02995733|144445300|SUPERIORITY|Asthma exacerbation rates during follow-up between two randomized treatment arms are compared using the Andersen-Gill adaptation of time-to-event Cox proportional hazard model with robust standard errors to account for multiple occurrences of the outcome in each patient (Andersen Gill, 1982). This analysis is based on intention-to-treat (ITT) patient population.|Cox Proportional Hazard|0.85||||0.048|TWO_SIDED|95.0|0.72|0.999|||Cox proportional hazard model|Pre-specified baseline covariates are adjusted in the model. A time-dependent covariate for the COVID pandemic is also included in adjustments.||||0.999|0.720|0.048
72621043|NCT02732145|144773169|EQUIVALENCE|Question: Is there a difference in the score for Marinoff Index (mean) among patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||0.9899|||||||Wilcoxon (Mann-Whitney)|||Parameter: The difference in the score for Marinoff Index (mean) in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology.||||0.9899
72392807|NCT02483520|144293177|SUPERIORITY|||||||0.005|||||||Wilcoxon (Mann-Whitney)|||p-values were calculated for within- group changes using Wilcoxon signed-rank test between baseline and 3 months||||.005
72392808|NCT02483520|144293178|SUPERIORITY|||||||0.677|||||||Wilcoxon (Mann-Whitney)|||p-values were calculated for differences between mean group changes using Wilcoxon rank-sum test at 3 months||||.677
72392809|NCT02483520|144293178|SUPERIORITY|||||||0.02|||||||Wilcoxon (Mann-Whitney)|||p-values were calculated for within- group changes using Wilcoxon signed-rank test between baseline and 3 months||||.020
72392810|NCT02483520|144293179|SUPERIORITY||LSM Estimate|-0.62||||0.432|TWO_SIDED|95.0|-2.18|0.94|||Mixed Models Analysis|||Linear mixed models were fitted to changes in outcomes with SAS Procedure Mixed. Efficacy of the FamTechCare intervention versus attention control was expressed as the model-estimated difference between the groups on mean change from baseline to 3 months. Burden, Depression, Sleep disturbance, Competence, Desire to institutionalize, Reaction to memory symptoms, Reaction to depression symptoms, Reaction to disruptive symptoms were included in the model.||0.94|-2.18|.432
72461263|NCT02995733|144445301|SUPERIORITY|Mixed model is used to compare the treatment effects. The response variable is ACT change at each monthly assessment from baseline. The covariates (included as fixed effects) include randomized treatment arm, continuous time of assessment as a linear and quadratic term and the interactions of the treatment arm with the time variables. Independent random effects include intercept and time variables. The model adjusts for all the baseline covariates included in the primary analysis.|Mean Difference (Final Values)|0.9|||||TWO_SIDED|95.0|0.5|1.2||||||||1.2|0.5|
72392811|NCT02483520|144293180|SUPERIORITY|||||||0.255|||||||Wilcoxon (Mann-Whitney)|||||||.255
72392812|NCT04492618|144293202|SUPERIORITY|||||||0.005|||||||Wilcoxon (Mann-Whitney)|||||||0.005
72392813|NCT02111772|144293212|SUPERIORITY|||||||0.049|||||||Negative binomial regression|||||||0.049
72392814|NCT02111772|144293213|SUPERIORITY||||||<|0.001|||||||Negative binomial regression|||||||<0.001
72461264|NCT02995733|144445302|SUPERIORITY|Mixed model is used to compare the treatment effects. The response variable is ASUI change at each monthly assessment from baseline. The covariates (included as fixed effects) include randomized treatment arm, continuous time of assessment as a linear and quadratic term and the interactions of the treatment arm with the time variables. Independent random effects include intercept and time variables. The model adjusts for all the baseline covariates included in the primary analysis.|Mean Difference (Final Values)|0.04|||||TWO_SIDED|95.0|0.02|0.05||||||||0.05|0.02|
72461265|NCT02995733|144445303|SUPERIORITY|Negative binomial regression model is used, with time as an offset to account for differential duration of follow-up. The model adjusts for all the baseline covariates included in the primary analysis.|Rate ratio|0.8|||||TWO_SIDED|95.0|0.67|0.95||||||||0.95|0.67|
72461266|NCT02720198|144445311|SUPERIORITY||Mean Difference (Final Values)|1.159|STANDARD_ERROR_OF_MEAN|1.834||0.53|TWO_SIDED|95.0|-2.518|4.836|||t-test, 2 sided|||||4.836|-2.518|0.53
72461267|NCT02720198|144445312|SUPERIORITY||Odds Ratio (OR)|0.492|STANDARD_ERROR_OF_MEAN|0.806||0.428|TWO_SIDED|95.0|0.101|2.388|||Mantel Haenszel|||||2.388|0.101|0.428
72461268|NCT02720198|144445313|SUPERIORITY||Odds Ratio (OR)|0.451|STANDARD_ERROR_OF_MEAN|0.724||0.272|TWO_SIDED|95.0|0.109|1.866|||Mantel Haenszel|||||1.866|0.109|0.272
72461269|NCT02720198|144445314|SUPERIORITY||Mean Difference (Final Values)|-0.624|STANDARD_ERROR_OF_MEAN|1.428||0.664|TWO_SIDED|95.0|-3.484|2.236|||t-test, 2 sided|||||2.236|-3.484|0.664
72461270|NCT02720198|144445315|SUPERIORITY||Mean Difference (Final Values)|2.34|STANDARD_ERROR_OF_MEAN|2.199||0.292|TWO_SIDED|95.0|-2.07|6.75|||t-test, 2 sided|||||6.750|-2.070|0.292
72461271|NCT02720198|144445316|SUPERIORITY||Odds Ratio (OR)|1.063|STANDARD_ERROR_OF_MEAN|0.525||0.884|TWO_SIDED|95.0|0.38|2.971|||Mantel Haenszel|||||2.971|0.380|0.884
72461272|NCT02720198|144445317|SUPERIORITY||Odds Ratio (OR)|0.875|STANDARD_ERROR_OF_MEAN|0.65||0.905|TWO_SIDED|95.0|0.245|3.129|||Mantel Haenszel|||||3.129|0.245|0.905
72461273|NCT02720198|144445318|SUPERIORITY||Mean Difference (Final Values)|1.64|STANDARD_ERROR_OF_MEAN|1.423||0.254|TWO_SIDED|95.0|-1.211|4.492|||t-test, 2 sided|||||4.492|-1.211|0.254
72461274|NCT02720198|144445319|SUPERIORITY||Mean Difference (Final Values)|-3.693|STANDARD_ERROR_OF_MEAN|1.91||0.058|TWO_SIDED|95.0|-7.52|0.134|||t-test, 2 sided|||||0.134|-7.520|0.058
72461275|NCT02720198|144445320|SUPERIORITY||Mean Difference (Final Values)|-0.236|STANDARD_ERROR_OF_MEAN|2.158||0.913|TWO_SIDED|95.0|-4.559|4.088|||t-test, 2 sided|||||4.088|-4.559|0.913
72461276|NCT02720198|144445321|SUPERIORITY||Mean Difference (Final Values)|-0.459|STANDARD_ERROR_OF_MEAN|1.035||0.66|TWO_SIDED|95.0|-2.54|1.623|||t-test, 2 sided|||||1.623|-2.540|0.660
72461277|NCT04879823|144445322|SUPERIORITY|||||||0.03|||||||t-test, 1 sided|||Null hypothesis: Average pain scores before medication will not be lower in the dexamethasone group compared with the placebo group.||||0.03
72461278|NCT04879823|144445323|SUPERIORITY|||||||0.07|||||||Fisher Exact|||Null hypothesis: There will be no difference in the proportion of patients visiting the emergency department or urgent care (at least 1 time) post-operatively between dexamethasone and placebo groups.||||0.07
72461279|NCT04879823|144445324|SUPERIORITY|||||||0.98|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: Average pain scores after medication will not be lower in the dexamethasone group compared with the placebo group.||||0.98
72461280|NCT01469819|144445360|SUPERIORITY_OR_OTHER||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||||||<0.01
72461281|NCT01469819|144445361|SUPERIORITY_OR_OTHER||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||||||<0.01
72461282|NCT01469819|144445362|SUPERIORITY_OR_OTHER||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||||||<0.01
72461283|NCT01469819|144445363|SUPERIORITY_OR_OTHER||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||||||<0.01
72461284|NCT01403805|144445365|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Fisher's test 'Vaccine' versus 'Oral Care and Vaccines' and 'phumonia' and 'not pneumonia'|Fisher Exact|||The results were analyzed as means ± standard deviation (SD) or numbers (%). Differences between the 2 nursing homes were compared using Fisher's test.||||<0.001
72461285|NCT01403805|144445366|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||Fisher Exact|||The results are expressed as means ± standard deviation (SD) or numbers (%). Differences between the 2 nursing homes were compared using Fisher's test.||||0.05
72461286|NCT04057937|144445371|SUPERIORITY||Percentage Difference:Apremilast-Placebo|37.4||||0.0003|TWO_SIDED|95.0|18.6|56.1||Two-sided 0.10 significant level|Chi-squared||Confidence Intervals calculated using the Wald method (normal approximation).|||56.1|18.6|0.0003
72461287|NCT05319756|144445391|SUPERIORITY||Mean Difference (Final Values)|32.8|STANDARD_ERROR_OF_MEAN|4.0|<|0.0001|ONE_SIDED|95.0|26.1||||Mixed Models Analysis|||"The sensitivity and integrity of the study was validated by comparing the mean responses of oxycodone HCl, the positive control (C), to the placebo (P):~H0: μC - μP ≤ δ1 versus Ha: μC - μP \> δ1 where δ1 =15"|||26.1|<.0001
72461288|NCT05319756|144445391|NON_INFERIORITY|Non-inferiority margin = 0|Mean Difference (Final Values)|-5.6|STANDARD_ERROR_OF_MEAN|4.46||0.1041|ONE_SIDED|95.0||1.7|||Mixed Models Analysis|||"The primary analysis evaluated whether gabapentin plus oxycodone HCl (T) produced mean responses that showed abuse potential that was no higher than oxycodone HCl (C). The margin for showing no significant difference was defined as 20% of the difference between oxycodone HCl (C) and Placebo (P):~H0: μT - μC ≥ 0.2(μC - μP) versus Ha: μT - μC \<0.2(μC - μP)."||1.7||0.1041
72461289|NCT05319756|144445391|NON_INFERIORITY|Non-inferiority margin = 0|Mean Difference (Final Values)|-1.9|STANDARD_ERROR_OF_MEAN|4.46||0.3373|ONE_SIDED|95.0||5.5|||Mixed Models Analysis|||"The primary analysis evaluated whether gabapentin plus oxycodone HCl (T) produced mean responses that showed abuse potential that was no higher than oxycodone HCl (C). The margin for showing no significant difference was defined as 20% of the difference between oxycodone HCl (C) and Placebo (P):~H0: μT - μC ≥ 0.2(μC - μP) versus Ha: μT - μC \<0.2(μC - μP)."||5.5||0.3373
72461290|NCT05319756|144445391|NON_INFERIORITY|Non-inferiority margin = 10|Mean Difference (Final Values)|-12.3|STANDARD_ERROR_OF_MEAN|3.63|<|0.0001|ONE_SIDED|95.0||-6.3|||Mixed Models Analysis|||"The null and alternative hypotheses for evaluating whether gabapentin (G) produced mean responses that show less abuse potential than oxycodone HCl (C) were:~H0: μC - μG ≤ 0.2(μC - 50) versus Ha: μC - μG \>0.2(μC - 50)"||-6.3||<.0001
72392815|NCT02495168|144293214|EQUIVALENCE|To show the clinical equivalence, an analysis of covariance (ANCOVA) model was fit on the participants from the generic budesonide/formoterol fumarate and Symbicort groups only, with the endpoint as outcome and treatment, study site and treatment by site interaction as fixed effects and FEV1 baseline value as covariate. If the treatment-by-site interaction factor was not significant at the 0.05 level, the model was to be rerun without the interaction term.|Test/Referece LS Mean Ratio|101.9|||||TWO_SIDED|90.0|92.7|111.9|||||Fieller's formula was applied to calculate the 90% confidence interval (CI) for the generic budesonide/formoterol fumarate and Symbicort LS mean ratio; covariance between treatment means was assumed to be 0.|||111.9|92.7|
72392816|NCT02495168|144293215|SUPERIORITY||LS Mean Difference|2.334|||<|0.0001|TWO_SIDED|95.0|1.673|2.996||Threshold for significance at 0.05 level.|ANCOVA|||LS means difference and p-value from ANCOVA model with treatment and site as fixed effects, baseline FEV1 as covariate and endpoint as outcome on generic budesonide/formoterol fumarate dihydrate and Placebo participants only.||2.996|1.673|<0.0001
72392817|NCT02495168|144293215|SUPERIORITY||LS Mean Difference|2.606|||<|0.0001|TWO_SIDED|95.0|1.939|3.273||Threshold for significance at 0.05 level.|ANCOVA|||LS means difference and p-value from ANCOVA model with treatment and site as fixed effects, baseline FEV1 as covariate and endpoint as outcome on Symbicort and Placebo participants only.||3.273|1.939|<0.0001
72392818|NCT02495168|144293216|EQUIVALENCE|To show the clinical equivalence, an ANCOVA model was fit on the participants from the generic budesonide/formoterol fumarate and Symbicort groups only, with the endpoint as outcome and treatment, study site and treatment-by site interaction as fixed effects and FEV1 baseline value as covariate. If the treatment-by-site interaction factor was not significant at the 0.05 level, the model was to be rerun without the interaction term.|Test/Reference LS Mean Ratio|99.8|||||TWO_SIDED|90.0|87.0|114.5|||||Fieller's formula was applied to calculate the 90% CI for the generic budesonide/formoterol fumarate and Symbicort LS mean ratio; covariance between treatment means was assumed to be 0.|||114.5|87.0|
72461291|NCT05319756|144445391|NON_INFERIORITY|Non-inferiority margin = 10|Mean Difference (Final Values)|-6.7|STANDARD_ERROR_OF_MEAN|3.64|<|0.0001|ONE_SIDED|95.0||-0.6|||Mixed Models Analysis|||"The null and alternative hypotheses for evaluating whether gabapentin (G) produced mean responses that show less abuse potential than oxycodone HCl (C) were:~H0: μC - μG ≤ 0.2(μC - 50) versus Ha: μC - μG \>0.2(μC - 50)"||-0.6||<0.0001
72461292|NCT05319756|144445391|NON_INFERIORITY|Non-inferiority margin = 11|Mean Difference (Final Values)|3.0|STANDARD_ERROR_OF_MEAN|4.0||0.0232|ONE_SIDED|95.0||9.6|||Mixed Models Analysis|||"The null and alternative hypotheses for evaluating whether gabapentin (G) produced mean responses that show abuse potential similar to placebo(P) were:~H0: μG - μP ≥ δ2 versus Ha: μG - μP \< δ2 where δ2 =11"||9.6||0.0232
72461293|NCT05319756|144445391|NON_INFERIORITY|Non-inferiority margin = 11|Mean Difference (Final Values)|8.6|STANDARD_ERROR_OF_MEAN|4.01||0.2767|ONE_SIDED|95.0||15.2|||Mixed Models Analysis|||"The null and alternative hypotheses for evaluating whether gabapentin (G) produced mean responses that show abuse potential similar to placebo(P) were:~H0: μG - μP ≥ δ2 versus Ha: μG - μP \< δ2 where δ2 =11."||15.2||0.2767
72461294|NCT05319756|144445393|OTHER||Mean Difference (Final Values)|267.1|STANDARD_ERROR_OF_MEAN|83.688||0.0016|TWO_SIDED|90.0|128.8|405.4|||Mixed Models Analysis|||||405.4|128.8|0.0016
72461295|NCT05319756|144445393|OTHER||Mean Difference (Final Values)|29.19|STANDARD_ERROR_OF_MEAN|83.688||0.7276|TWO_SIDED|90.0|-109.0|167.5|||Mixed Models Analysis|||||167.5|-109|0.7276
72461296|NCT05319756|144445393|OTHER||Mean Difference (Final Values)|50.41|STANDARD_ERROR_OF_MEAN|83.785||0.5481|TWO_SIDED|90.0|-88.0|188.9|||Mixed Models Analysis|||||188.9|-88.0|0.5481
72461297|NCT05319756|144445393|OTHER||Mean Difference (Final Values)|350.7|STANDARD_ERROR_OF_MEAN|84.023|<|0.0001|TWO_SIDED|90.0|211.8|489.5|||Mixed Models Analysis|||||489.5|211.8|<0.0001
72461298|NCT05319756|144445393|OTHER||Mean Difference (Final Values)|364.4|STANDARD_ERROR_OF_MEAN|83.785|<|0.0001|TWO_SIDED|90.0|225.9|502.8|||Mixed Models Analysis|||||502.8|225.9|<0.0001
72621044|NCT02732145|144773169|EQUIVALENCE|Question: Is there a difference in the score for the Cotton-Swab test (mean) among the patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||0.9686|||||||Wilcoxon (Mann-Whitney)|||Parameter: The difference in the score for the Cotton-Swab test (mean) in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology.||||0.9686
72392819|NCT02495168|144293217|SUPERIORITY||LS Mean Difference|0.159|||<|0.0001|TWO_SIDED|95.0|0.093|0.226||Threshold for significance at 0.05 level.|ANCOVA|||LS means difference and p-value from ANCOVA model with treatment and site as fixed effects, baseline FEV1 as covariate and endpoint as outcome on generic budesonide/formoterol fumarate dihydrate and Placebo participants only.||0.226|0.093|<0.0001
72392820|NCT02495168|144293217|SUPERIORITY||LS Mean Difference|0.164|||<|0.0001|TWO_SIDED|95.0|0.099|0.229||Threshold for significance at 0.05 level.|ANCOVA|||LS means difference and p-value from ANCOVA model with treatment and site as fixed effects, baseline FEV1 as covariate and endpoint as outcome on Symbicort and Placebo participants only.||0.229|0.099|<0.0001
72461299|NCT05319756|144445393|OTHER||Mean Difference (Final Values)|-238.0|STANDARD_ERROR_OF_MEAN|83.785||0.005|TWO_SIDED|90.0|-376.0|-99.4|||Mixed Models Analysis|||||-99.4|-376|0.0050
72461300|NCT05319756|144445393|OTHER||Mean Difference (Final Values)|-217.0|STANDARD_ERROR_OF_MEAN|84.023||0.0106|TWO_SIDED|90.0|-356.0|-77.8|||Mixed Models Analysis|||||-77.8|-356|0.0106
72461301|NCT05319756|144445393|OTHER||Mean Difference (Final Values)|83.6|STANDARD_ERROR_OF_MEAN|83.785||0.3196|TWO_SIDED|90.0|-54.9|222.1|||Mixed Models Analysis|||||222.1|-54.9|0.3196
72461302|NCT05319756|144445393|OTHER||Mean Difference (Final Values)|97.29|STANDARD_ERROR_OF_MEAN|83.688||0.2464|TWO_SIDED|90.0|-41.0|235.6|||Mixed Models Analysis|||||235.6|-41.0|0.2464
72461303|NCT05319756|144445399|OTHER||Mean Difference (Final Values)|64.67|STANDARD_ERROR_OF_MEAN|7.581|<|0.0001|TWO_SIDED|90.0|52.15|77.2|||Mixed Models Analysis|||||77.20|52.15|<.0001
72461304|NCT05319756|144445399|OTHER||Mean Difference (Final Values)|14.66|STANDARD_ERROR_OF_MEAN|7.581||0.0546|TWO_SIDED|90.0|2.13|27.1|||Mixed Models Analysis|||||27.1|2.13|0.0546
72461305|NCT05319756|144445399|OTHER||Mean Difference (Final Values)|11.58|STANDARD_ERROR_OF_MEAN|7.589||0.1286|TWO_SIDED|90.0|-0.96|24.12|||Mixed Models Analysis|||||24.12|-0.96|0.1286
72461306|NCT05319756|144445399|OTHER||Mean Difference (Final Values)|68.99|STANDARD_ERROR_OF_MEAN|7.611|<|0.0001|TWO_SIDED|90.0|56.42|81.57|||Mixed Models Analysis|||||81.57|56.42|<.0001
72461307|NCT05319756|144445399|OTHER||Mean Difference (Final Values)|76.37|STANDARD_ERROR_OF_MEAN|7.589|<|0.0001|TWO_SIDED|90.0|63.83|88.91|||Mixed Models Analysis|||||88.91|63.83|<.0001
72461308|NCT05319756|144445399|OTHER||Mean Difference (Final Values)|-50.0|STANDARD_ERROR_OF_MEAN|7.589|<|0.0001|TWO_SIDED|90.0|-62.6|-37.5|||Mixed Models Analysis|||||-37.5|-62.6|<.0001
72563510|NCT01844531|144658285|SUPERIORITY_OR_OTHER||Adjusted gMean ratio FDC/single tablets|97.92|STANDARD_ERROR_OF_MEAN|8.4||0|TWO_SIDED|90.0|93.529|102.52||Model included effects:sequence;subjects within sequences;period and treatment with subjects within sequences as random effect.|ANOVA||\*Results reported as Standard Error of the mean are Intra-individual geometric coefficient of variation \[%\].|Adjusted by-treatment geometric means and relative bioavailability comparison FDC Empa12.5 : Empa12.5 + Met500, PK set AUCinfpred \[nmol\*h/L\] for EMPAGLIFLOZIN (PLASMA EDTA). The statistical model used was an analysis of variance (ANOVA) model on the logarithmic scale.||102.520|93.529|0.0000
72563511|NCT01844531|144658285|SUPERIORITY_OR_OTHER||Adjusted gMean ratio FDC/single tablets|98.0|STANDARD_ERROR_OF_MEAN|8.3|<|0.0001|TWO_SIDED|90.0|93.57|102.65||Model included effects:sequence;subjects within sequences;period and treatment with all effects as fixed.|ANOVA||\*Results reported as Standard Error of the mean are Intra-individual geometric coefficient of variation \[%\].|Adjusted by-treatment geometric means and relative bioavailability - analysis with fixed effects for all terms comparison FDC Empa12.5 : Empa12.5 + Met500, PK set AUCinfpred \[nmol\*h/L\] for EMPAGLIFLOZIN (PLASMA EDTA). The statistical model used was an analysis of variance (ANOVA) model on the logarithmic scale.||102.65|93.57|<.0001
72461309|NCT05319756|144445399|OTHER||Mean Difference (Final Values)|-53.1|STANDARD_ERROR_OF_MEAN|7.611|<|0.0001|TWO_SIDED|90.0|-65.7|-40.5|||Mixed Models Analysis|||||-40.5|-65.7|<.0001
72563512|NCT01844531|144658285|SUPERIORITY_OR_OTHER||Adjusted gMean ratio FDC/single tablets|102.79|STANDARD_ERROR_OF_MEAN|6.7||0|TWO_SIDED|90.0|99.077|106.633||Model included effects:sequence;subjects within sequences;period and treatment with subjects within sequences as random effect.|ANOVA||\*Results reported as Standard Error of the mean are Intra-individual geometric coefficient of variation \[%\].|Adjusted by-treatment geometric means and relative bioavailability comparison FDC Empa5 : Empa5 + Met500 , PK set AUCinfpred \[nmol\*h/L\] for EMPAGLIFLOZIN (PLASMA EDTA). The statistical model used was an analysis of variance (ANOVA) model on the logarithmic scale.||106.633|99.077|0.0000
72563513|NCT01844531|144658285|SUPERIORITY_OR_OTHER||Adjusted gMean ratio FDC/single tablets|102.5|STANDARD_ERROR_OF_MEAN|6.7|<|0.0001|TWO_SIDED|90.0|98.78|106.36|||ANOVA||\*Results reported as Standard Error of the mean are Intra-individual geometric coefficient of variation \[%\].|Adjusted by-treatment geometric means and relative bioavailability - analysis with fixed effects for all terms comparison FDC Empa5 (T2) : Empa5 + Met500 (R2), PK set AUCinfpred \[nmol\*h/L\] for EMPAGLIFLOZIN (PLASMA EDTA)||106.36|98.78|<.0001
72563514|NCT01844531|144658286|SUPERIORITY_OR_OTHER||Adjusted gMean ratio FDC/single tablets|96.25|STANDARD_ERROR_OF_MEAN|15.4||0.0006|TWO_SIDED|90.0|88.542|104.628|||ANOVA||\*Results reported as Standard Error of the mean are Intra-individual geometric coefficient of variation \[%\].|Adjusted by-treatment geometric means and relative bioavailability comparison FDC Empa12.5 : Empa12.5 + Met500, PK set AUCinfpred \[ng\*h/mL\] for METFORMIN (PLASMA EDTA)||104.628|88.542|0.0006
72563515|NCT01844531|144658286|SUPERIORITY_OR_OTHER||Adjusted gMean ratio FDC/single tablets|97.21|STANDARD_ERROR_OF_MEAN|15.1||0.0004|TWO_SIDED|90.0|89.41|105.68|||ANOVA||\*Results reported as Standard Error of the mean are Intra-individual geometric coefficient of variation \[%\].|Adjusted by-treatment geometric means and relative bioavailability - analysis with fixed effects for all terms comparison FDC Empa12.5 (T1) : Empa12.5 + Met500 (R1), PK set AUCinfpred \[ng\*h/mL\] for METFORMIN (PLASMA EDTA)||105.68|89.41|0.0004
72563516|NCT01844531|144658286|SUPERIORITY_OR_OTHER||Adjusted gMean ratio FDC/single tablets|96.79|STANDARD_ERROR_OF_MEAN|9.8||0|TWO_SIDED|90.0|91.772|102.093|||ANOVA||\*Results reported as Standard Error of the mean are Intra-individual geometric coefficient of variation \[%\].|Adjusted by-treatment geometric means and relative bioavailability comparison FDC Empa5 : Empa5 + Met500, PK set AUCinfpred \[ng\*h/mL\] for METFORMIN (PLASMA EDTA)||102.093|91.772|0.0000
72563517|NCT01844531|144658286|SUPERIORITY_OR_OTHER||Adjusted gMean ratio FDC/single tablets|96.91|STANDARD_ERROR_OF_MEAN|9.8|<|0.0001|TWO_SIDED|90.0|91.79|102.32|||ANOVA||\*Results reported as Standard Error of the mean are Intra-individual geometric coefficient of variation \[%\].|Adjusted by-treatment geometric means and relative bioavailability - analysis with fixed effects for all terms comparison FDC Empa5 : Empa5 + Met500, PK set AUCinfpred \[ng\*h/mL\] for METFORMIN (PLASMA EDTA)||102.32|91.79|<.0001
72563518|NCT01844531|144658287|SUPERIORITY_OR_OTHER||Adjusted gMean ratio FDC/single tablets|98.0|STANDARD_ERROR_OF_MEAN|8.5||0|TWO_SIDED|90.0|93.53|102.686|||ANOVA||\*Results reported as Standard Error of the mean are Intra-individual geometric coefficient of variation \[%\].|Adjusted by-treatment geometric means and relative bioavailability comparison FDC Empa12.5 : Empa12.5 + Met500, PK set AUClast \[nmol\*h/L\] for EMPAGLIFLOZIN (PLASMA EDTA)||102.686|93.530|0.0000
72563519|NCT01844531|144658287|SUPERIORITY_OR_OTHER||Adjusted gMean ratio FDC/single tablets|98.07|STANDARD_ERROR_OF_MEAN|8.5|<|0.0001|TWO_SIDED|90.0|93.55|102.81|||ANOVA||\*Results reported as Standard Error of the mean are Intra-individual geometric coefficient of variation \[%\].|Adjusted by-treatment geometric means and relative bioavailability - analysis with fixed effects for all terms comparison FDC Empa12.5 : Empa12.5 + Met500, PK set AUClast \[nmol\*h/L\] for EMPAGLIFLOZIN (PLASMA EDTA)||102.81|93.55|<.0001
72621045|NCT02732145|144773169|EQUIVALENCE|Question: Is there a difference in the score for any lesion in any vulvar ring (mean) among the patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||0.7055|||||||Wilcoxon (Mann-Whitney)|||Parameter: The difference in the score for any lesion in any vulvar ring (mean) in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology.||||0.7055
72621046|NCT02732145|144773169|EQUIVALENCE|Question: Is there a difference in the score for any vulvar lesion of the Outer Vulvar Ring (mean) among the patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||0.8852|||||||Wilcoxon (Mann-Whitney)|||Parameter: The difference in the score for any vulvar lesion of the Outer Vulvar Ring (mean) in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology.||||0.8852
72392821|NCT01603056|144293218|SUPERIORITY_OR_OTHER|||||||0.743|TWO_SIDED||||||t-test, 2 sided|||||||0.743
72461310|NCT05319756|144445399|OTHER||Mean Difference (Final Values)|4.32|STANDARD_ERROR_OF_MEAN|7.589||0.5699|TWO_SIDED|90.0|-8.22|16.86|||Mixed Models Analysis|||||16.86|-8.22|0.5699
72461311|NCT05319756|144445399|OTHER||Mean Difference (Final Values)|11.7|STANDARD_ERROR_OF_MEAN|7.581||0.1243|TWO_SIDED|90.0|-0.83|24.23|||Mixed Models Analysis|||||24.23|-0.83|0.1243
72461312|NCT05319756|144445401|OTHER||Mean Difference (Final Values)|286.7|STANDARD_ERROR_OF_MEAN|50.879|<|0.0001|TWO_SIDED|90.0|202.6|370.8|||Mixed Models Analysis|||||370.8|202.6|<.0001
72621047|NCT02732145|144773169|EQUIVALENCE|Question: Is there a difference in the score for any vulvar lesion of the Middle Vulvar Ring (mean) among the patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||1|||||||Wilcoxon (Mann-Whitney)|||Parameter: The difference in the score for any vulvar lesion of the Middle Vulvar Ring (mean) in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology.||||1.0000
72621048|NCT02732145|144773169|EQUIVALENCE|Question: Is there a difference in the score for any vulvar lesion of the Inner Vulvar Ring (mean) among the patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||0.3351|||||||Wilcoxon (Mann-Whitney)|||Parameter: The difference in the score for any vulvar lesion of the Inner Vulvar Ring (mean) in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology.||||0.3351
72621049|NCT02732145|144773169|EQUIVALENCE|Question: Is there a difference in the score for the specificity of vulvar lesions (mean) among the patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||0.8673|||||||Wilcoxon (Mann-Whitney)|||Parameter: The difference in the score for the specificity of vulvar lesions (mean) in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology.||||0.8673
72621050|NCT02732145|144773169|EQUIVALENCE|Question: Is there a difference in the score for non-specific vulvar lesions (mean) among the patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||0.8673|||||||Wilcoxon (Mann-Whitney)|||Parameter: The difference in the score for non-specific vulvar lesions (mean) in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology.||||0.8673
72621051|NCT02732145|144773169|EQUIVALENCE|Question: Is there a difference in the score for specific vulvar lesions (mean) among the patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||1|||||||Wilcoxon (Mann-Whitney)|||Parameter: The difference in the score for specific vulvar lesions (mean) with vulvar dermatosis diagnosed by vulvoscopy and histopathology.||||1.0000
72621052|NCT02732145|144773169|EQUIVALENCE|"Question: Is there a difference in the overall sum of points for the Vulvoscopy Index (mean) among the patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology?"||||||0.8472|||||||Wilcoxon (Mann-Whitney)|||"Parameter: The difference in the overall sum of points for the Vulvoscopy Index (mean) in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology."||||0.8472
72621053|NCT02732145|144773171|EQUIVALENCE|Question: Is there a difference in the score for vulvar complaints (median) among the patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||1|||||||Wilcoxon (Mann-Whitney)|||Parameter: The difference in the score for vulvar complaints (median) in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology.||||1.0000
72621054|NCT02732145|144773171|EQUIVALENCE|Question: Is there a difference in the score for Marinoff Index (median) among the patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||0.9629|||||||Wilcoxon (Mann-Whitney)|||Parameter: The difference in the score for Marinoff Index (median) in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology.||||0.9629
72621055|NCT02732145|144773171|EQUIVALENCE|Question: Is there a difference in the score for the Cotton-Swab test (median) among the patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||0.9155|||||||Wilcoxon (Mann-Whitney)|||Parameter: The difference in the score for the Cotton-Swab test (median) in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology.||||0.9155
72621056|NCT02732145|144773171|EQUIVALENCE|Question: Is there a difference in the score for any lesion in any vulvar ring (median) among the patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||0.4913|||||||Wilcoxon (Mann-Whitney)|||Parameter: The difference in the score for any lesion in any vulvar ring (median) in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology.||||0.4913
72461313|NCT05319756|144445401|OTHER||Mean Difference (Final Values)|53.85|STANDARD_ERROR_OF_MEAN|50.879||0.2912|TWO_SIDED|90.0|-30.2|137.9|||Mixed Models Analysis|||||137.9|-30.2|0.2912
72461314|NCT05319756|144445401|OTHER||Mean Difference (Final Values)|97.8|STANDARD_ERROR_OF_MEAN|50.938||0.0563|TWO_SIDED|90.0|13.62|182.0|||Mixed Models Analysis|||||182.0|13.62|0.0563
72461315|NCT05319756|144445401|OTHER||Mean Difference (Final Values)|484.5|STANDARD_ERROR_OF_MEAN|51.083|<|0.0001|TWO_SIDED|90.0|400.1|569.0|||Mixed Models Analysis|||||569.0|400.1|<.0001
72621057|NCT02732145|144773171|EQUIVALENCE|Question: Is there a difference in the score for any vulvar lesion of the Outer Vulvar Ring (median) among the patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||0.8866|||||||Wilcoxon (Mann-Whitney)|||Parameter: The difference in the score for any vulvar lesion of the Outer Vulvar Ring (median) in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology.||||0.8866
72621058|NCT02732145|144773171|EQUIVALENCE|Question: Is there a difference in the score for any vulvar lesion of the Middle Vulvar Ring (median) among the patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||1|||||||Wilcoxon (Mann-Whitney)|||Parameter: The difference in the score for any vulvar lesion of the Middle Vulvar Ring (median) in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology.||||1.0000
72621059|NCT02732145|144773171|EQUIVALENCE|Question: Is there a difference in the score for any vulvar lesion of the Inner Vulvar Ring (median) among the patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||0.3335|||||||Wilcoxon (Mann-Whitney)|||Parameter: The difference in the score for any vulvar lesion of the Inner Vulvar Ring (median) in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology.||||0.3335
72621060|NCT02732145|144773171|EQUIVALENCE|Question: Is there a difference in the score for the specificity of vulvar lesions (median) among the patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||0.8666|||||||Wilcoxon (Mann-Whitney)|||Parameter: The difference in the score for the specificity of vulvar lesions (median) in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology.||||0.8666
72621061|NCT02732145|144773171|EQUIVALENCE|Question: Is there a difference in the score for non-specific vulvar lesions (median) among the patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||0.8666|||||||Wilcoxon (Mann-Whitney)|||Parameter: The difference in the score for non-specific vulvar lesions (median) in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology.||||0.8666
72461316|NCT05319756|144445401|OTHER||Mean Difference (Final Values)|396.6|STANDARD_ERROR_OF_MEAN|50.938|<|0.0001|TWO_SIDED|90.0|312.4|480.8|||Mixed Models Analysis|||||480.8|312.4|<.0001
72461317|NCT05319756|144445401|OTHER||Mean Difference (Final Values)|-233.0|STANDARD_ERROR_OF_MEAN|50.938|<|0.0001|TWO_SIDED|90.0|-317.0|-149.0|||Mixed Models Analysis|||||-149|-317|<.0001
72392822|NCT01603056|144293219|SUPERIORITY_OR_OTHER|||||||0.627|TWO_SIDED||||||t-test, 2 sided|||||||0.627
72461318|NCT05319756|144445401|OTHER||Mean Difference (Final Values)|-189.0|STANDARD_ERROR_OF_MEAN|51.083||0.0003|TWO_SIDED|90.0|-273.0|-105.0|||Mixed Models Analysis|||||-105|-273|0.0003
72461319|NCT05319756|144445401|OTHER||Mean Difference (Final Values)|197.8|STANDARD_ERROR_OF_MEAN|50.938||0.0001|TWO_SIDED|90.0|113.7|282.0|||Mixed Models Analysis|||||282.0|113.7|0.0001
72461320|NCT05319756|144445401|OTHER||Mean Difference (Final Values)|109.9|STANDARD_ERROR_OF_MEAN|50.879||0.032|TWO_SIDED|90.0|25.8|194.0|||Mixed Models Analysis|||||194.0|25.80|0.0320
72461321|NCT05319756|144445402|OTHER||Mean Difference (Final Values)|18.73|STANDARD_ERROR_OF_MEAN|2.276|<|0.0001|TWO_SIDED|90.0|14.98|22.48|||Mixed Models Analysis|||||22.48|14.98|<0.0001
72461322|NCT05319756|144445402|OTHER||Mean Difference (Final Values)|1.76|STANDARD_ERROR_OF_MEAN|2.302||0.5056|TWO_SIDED|90.0|-2.03|5.56|||Mixed Models Analysis|||||5.56|-2.03|0.5056
72461323|NCT05319756|144445402|OTHER||Mean Difference (Final Values)|4.62|STANDARD_ERROR_OF_MEAN|2.307||0.076|TWO_SIDED|90.0|0.82|8.42|||Mixed Models Analysis|||||8.42|0.82|0.0760
72461324|NCT05319756|144445402|OTHER||Mean Difference (Final Values)|25.73|STANDARD_ERROR_OF_MEAN|2.315|<|0.0001|TWO_SIDED|90.0|21.92|29.54|||Mixed Models Analysis|||||29.54|21.92|<0.0001
72461325|NCT05319756|144445402|OTHER||Mean Difference (Final Values)|24.42|STANDARD_ERROR_OF_MEAN|2.27|<|0.0001|TWO_SIDED|90.0|20.68|28.16|||Mixed Models Analysis|||||28.16|20.68|<0.0001
72461326|NCT05319756|144445402|OTHER||Mean Difference (Final Values)|-17.0|STANDARD_ERROR_OF_MEAN|2.297|<|0.0001|TWO_SIDED|90.0|-20.8|-13.2|||Mixed Models Analysis|||||-13.2|-20.8|<0.0001
72461327|NCT05319756|144445402|OTHER||Mean Difference (Final Values)|-14.1|STANDARD_ERROR_OF_MEAN|2.299|<|0.0001|TWO_SIDED|90.0|-17.9|-10.3|||Mixed Models Analysis|||||-10.3|-17.9|<0.0001
72461328|NCT05319756|144445402|OTHER||Mean Difference (Final Values)|7.0|STANDARD_ERROR_OF_MEAN|2.298||0.0024|TWO_SIDED|90.0|3.22|10.79|||Mixed Models Analysis|||||10.79|3.22|0.0024
72461329|NCT05319756|144445402|OTHER||Mean Difference (Final Values)|5.69|STANDARD_ERROR_OF_MEAN|2.255||0.0118|TWO_SIDED|90.0|1.98|9.41|||Mixed Models Analysis|||||9.41|1.98|0.0118
72461330|NCT05319756|144445403|OTHER||Mean Difference (Final Values)|20.31|STANDARD_ERROR_OF_MEAN|2.246|<|0.0001|TWO_SIDED|90.0|16.61|24.01|||Mixed Models Analysis|||||24.01|16.61|<0.0001
72461331|NCT05319756|144445403|OTHER||Mean Difference (Final Values)|2.65|STANDARD_ERROR_OF_MEAN|2.271||0.2439|TWO_SIDED|90.0|-1.09|6.39|||Mixed Models Analysis|||||6.39|-1.09|0.2439
72461332|NCT05319756|144445403|OTHER||Mean Difference (Final Values)|6.5|STANDARD_ERROR_OF_MEAN|2.276||0.0044|TWO_SIDED|90.0|2.75|10.25|||Mixed Models Analysis|||||10.25|2.75|0.0044
72461333|NCT05319756|144445403|OTHER||Mean Difference (Final Values)|24.15|STANDARD_ERROR_OF_MEAN|2.284|<|0.0001|TWO_SIDED|90.0|20.39|27.91|||Mixed Models Analysis|||||27.91|20.39|<0.0001
72461334|NCT05319756|144445403|OTHER||Mean Difference (Final Values)|28.19|STANDARD_ERROR_OF_MEAN|2.24|<|0.0001|TWO_SIDED|90.0|24.5|31.88|||Mixed Models Analysis|||||31.88|24.50|<0.0001
72461335|NCT05319756|144445403|OTHER||Mean Difference (Final Values)|-17.7|STANDARD_ERROR_OF_MEAN|2.266|<|0.0001|TWO_SIDED|90.0|-21.4|-13.9|||Mixed Models Analysis|||||-13.9|-21.4|<0.0001
72461336|NCT05319756|144445403|OTHER||Mean Difference (Final Values)|-13.8|STANDARD_ERROR_OF_MEAN|2.268|<|0.0001|TWO_SIDED|90.0|-17.5|-10.1|||Mixed Models Analysis|||||-10.1|-17.5|<0.0001
72461337|NCT05319756|144445403|OTHER||Mean Difference (Final Values)|3.84|STANDARD_ERROR_OF_MEAN|2.267||0.0907|TWO_SIDED|90.0|0.11|7.57|||Mixed Models Analysis|||||7.57|0.11|0.0907
72461338|NCT05319756|144445403|OTHER||Mean Difference (Final Values)|7.88|STANDARD_ERROR_OF_MEAN|2.225||0.0004|TWO_SIDED|90.0|4.22|11.55|||Mixed Models Analysis|||||11.55|4.22|0.0004
72461339|NCT05319756|144445404|OTHER||Mean Difference (Final Values)|25.37|STANDARD_ERROR_OF_MEAN|1.528|<|0.0001|TWO_SIDED|90.0|22.86|27.88|||Mixed Models Analysis|||||27.88|22.86|<0.0001
72461340|NCT05319756|144445404|OTHER||Mean Difference (Final Values)|3.59|STANDARD_ERROR_OF_MEAN|1.529||0.0189|TWO_SIDED|90.0|1.08|6.11|||Mixed Models Analysis|||||6.11|1.08|0.0189
72461341|NCT05319756|144445404|OTHER||Mean Difference (Final Values)|6.18|STANDARD_ERROR_OF_MEAN|1.536|<|0.0001|TWO_SIDED|90.0|3.66|8.71|||Mixed Models Analysis|||||8.71|3.66|<0.0001
72461342|NCT05319756|144445404|OTHER||Mean Difference (Final Values)|32.18|STANDARD_ERROR_OF_MEAN|1.537|<|0.0001|TWO_SIDED|90.0|29.65|34.71|||Mixed Models Analysis|||||34.71|29.65|<0.0001
72461343|NCT05319756|144445404|OTHER||Mean Difference (Final Values)|30.17|STANDARD_ERROR_OF_MEAN|1.525|<|0.0001|TWO_SIDED|90.0|27.66|32.68|||Mixed Models Analysis|||||32.68|27.66|<0.0001
72461344|NCT05319756|144445404|OTHER||Mean Difference (Final Values)|-21.8|STANDARD_ERROR_OF_MEAN|1.522|<|0.0001|TWO_SIDED|90.0|-24.3|-19.3|||Mixed Models Analysis|||||-19.3|-24.3|<0.0001
72461345|NCT05319756|144445404|OTHER||Mean Difference (Final Values)|-19.2|STANDARD_ERROR_OF_MEAN|1.53|<|0.0001|TWO_SIDED|90.0|-21.7|-16.7|||Mixed Models Analysis|||||-16.7|-21.7|<0.0001
72461346|NCT05319756|144445404|OTHER||Mean Difference (Final Values)|6.81|STANDARD_ERROR_OF_MEAN|1.524|<|0.0001|TWO_SIDED|90.0|4.3|9.31|||Mixed Models Analysis|||||9.31|4.30|<0.0001
72461347|NCT05319756|144445404|OTHER||Mean Difference (Final Values)|4.8|STANDARD_ERROR_OF_MEAN|1.514||0.0015|TWO_SIDED|90.0|2.31|7.29|||Mixed Models Analysis|||||7.29|2.31|0.0015
72392823|NCT01603056|144293220|SUPERIORITY_OR_OTHER|||||||0.74|TWO_SIDED||||||t-test, 2 sided|||||||0.74
72392824|NCT01603056|144293221|SUPERIORITY_OR_OTHER|||||||0.641|TWO_SIDED||||||t-test, 2 sided|||||||0.641
72392825|NCT01603056|144293222|SUPERIORITY_OR_OTHER|||||||0.818|TWO_SIDED||||||t-test, 2 sided|||||||0.818
72392826|NCT01603056|144293223|SUPERIORITY_OR_OTHER|||||||0.391|TWO_SIDED||||||t-test, 2 sided|||||||0.391
72461348|NCT05319756|144445405|OTHER||Mean Difference (Final Values)|4.23|STANDARD_ERROR_OF_MEAN|0.743|<|0.0001|TWO_SIDED|90.0|3.01|5.45|||Mixed Models Analysis|||||5.45|3.01|<.0001
72461349|NCT05319756|144445405|OTHER||Mean Difference (Final Values)|0.63|STANDARD_ERROR_OF_MEAN|0.743||0.3933|TWO_SIDED|90.0|-0.59|1.86|||Mixed Models Analysis|||||1.86|-0.59|0.3933
72461350|NCT05319756|144445405|OTHER||Mean Difference (Final Values)|0.79|STANDARD_ERROR_OF_MEAN|0.747||0.2916|TWO_SIDED|90.0|-0.44|2.02|||Mixed Models Analysis|||||2.02|-0.44|0.2916
72621062|NCT02732145|144773171|EQUIVALENCE|Question: Is there a difference in the score for specific vulvar lesions (median) among the patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||1|||||||Wilcoxon (Mann-Whitney)|||Parameter: The difference in the score for specific vulvar lesions (median) with vulvar dermatosis diagnosed by vulvoscopy and histopathology.||||1.0000
72621063|NCT02732145|144773171|EQUIVALENCE|"Question: Is there a difference in the overall sum of points for the Vulvoscopy Index (median) among the patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology?"||||||0.8144|||||||Wilcoxon (Mann-Whitney)|||"Parameter: The difference in the overall sum of points for the Vulvoscopy Index (median) in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology."||||0.8144
72621064|NCT02732145|144773172|EQUIVALENCE|Question: Is there a difference in the score for vulvar complaints in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||0.5403|||||||Wilcoxon (Mann-Whitney)|||Parameter: The difference in the score for vulvar complaints (median) in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology.||||0.5403
72461351|NCT05319756|144445405|OTHER||Mean Difference (Final Values)|3.92|STANDARD_ERROR_OF_MEAN|0.748|<|0.0001|TWO_SIDED|90.0|2.69|5.15|||Mixed Models Analysis|||||5.15|2.69|<.0001
72461352|NCT05319756|144445405|OTHER||Mean Difference (Final Values)|3.22|STANDARD_ERROR_OF_MEAN|0.742|<|0.0001|TWO_SIDED|90.0|2.0|4.44|||Mixed Models Analysis|||||4.44|2.00|<.0001
72461353|NCT05319756|144445405|OTHER||Mean Difference (Final Values)|-3.59|STANDARD_ERROR_OF_MEAN|0.74|<|0.0001|TWO_SIDED|90.0|-4.81|-2.38|||Mixed Models Analysis|||||-2.38|-4.81|<.0001
72461354|NCT05319756|144445405|OTHER||Mean Difference (Final Values)|-3.44|STANDARD_ERROR_OF_MEAN|0.744|<|0.0001|TWO_SIDED|90.0|-4.66|-2.22|||Mixed Models Analysis|||||-2.22|-4.66|<.0001
72461355|NCT05319756|144445405|OTHER||Mean Difference (Final Values)|-0.31|STANDARD_ERROR_OF_MEAN|0.741||0.6765|TWO_SIDED|90.0|-1.53|0.91|||Mixed Models Analysis|||||0.91|-1.53|0.6765
72461356|NCT05319756|144445405|OTHER||Mean Difference (Final Values)|-1.01|STANDARD_ERROR_OF_MEAN|0.737||0.1712|TWO_SIDED|90.0|-2.22|0.2|||Mixed Models Analysis|||||0.20|-2.22|0.1712
72461357|NCT05319756|144445406|OTHER||Mean Difference (Final Values)|24.7|STANDARD_ERROR_OF_MEAN|1.526|<|0.0001|TWO_SIDED|90.0|22.19|27.21|||Mixed Models Analysis|||||27.21|22.19|<.0001
72461358|NCT05319756|144445406|OTHER||Mean Difference (Final Values)|2.87|STANDARD_ERROR_OF_MEAN|1.527||0.0606|TWO_SIDED|90.0|0.35|5.38|||Mixed Models Analysis|||||5.38|0.35|0.0606
72461359|NCT05319756|144445406|OTHER||Mean Difference (Final Values)|4.11|STANDARD_ERROR_OF_MEAN|1.534||0.0074|TWO_SIDED|90.0|1.59|6.64|||Mixed Models Analysis|||||6.64|1.59|0.0074
72461360|NCT05319756|144445406|OTHER||Mean Difference (Final Values)|30.58|STANDARD_ERROR_OF_MEAN|1.536|<|0.0001|TWO_SIDED|90.0|28.05|33.1|||Mixed Models Analysis|||||33.10|28.05|<.0001
72461361|NCT05319756|144445406|OTHER||Mean Difference (Final Values)|29.99|STANDARD_ERROR_OF_MEAN|1.524|<|0.0001|TWO_SIDED|90.0|27.48|32.5|||Mixed Models Analysis|||||32.50|27.48|<.0001
72461362|NCT05319756|144445406|OTHER||Mean Difference (Final Values)|-21.8|STANDARD_ERROR_OF_MEAN|1.521|<|0.0001|TWO_SIDED|90.0|-24.3|-19.3|||Mixed Models Analysis|||||-19.3|-24.3|<.0001
72461363|NCT05319756|144445406|OTHER||Mean Difference (Final Values)|-20.6|STANDARD_ERROR_OF_MEAN|1.529|<|0.0001|TWO_SIDED|90.0|-23.1|-18.1|||Mixed Models Analysis|||||-18.1|-23.1|<.0001
72461364|NCT05319756|144445406|OTHER||Mean Difference (Final Values)|5.88|STANDARD_ERROR_OF_MEAN|1.523||0.0001|TWO_SIDED|90.0|3.37|8.38|||Mixed Models Analysis|||||8.38|3.37|0.0001
72461365|NCT05319756|144445406|OTHER||Mean Difference (Final Values)|5.29|STANDARD_ERROR_OF_MEAN|1.513||0.0005|TWO_SIDED|90.0|2.8|7.78|||Mixed Models Analysis|||||7.78|2.80|0.0005
72461366|NCT00422162|144445417|SUPERIORITY_OR_OTHER|||||||0.88||95.0||||P-value for Change from Baseline. A priori alpha threshold was 0.05 with no adjustment for multiple testing.|ANCOVA|ANCOVA with stratification factors (country and pretreatment for MDD) and MADRS baseline as covariates and treatment regimen as the main factor.||||||0.88
72461367|NCT00422162|144445427|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||P-value for Change from Baseline (within group)|t-test, 2 sided|paired t-test||||||<0.0001
72461368|NCT00422162|144445427|SUPERIORITY_OR_OTHER|||||||0.001||95.0||||P-value for Change from Baseline (within group)|t-test, 2 sided|paired t-test||||||0.001
72461369|NCT00422162|144445427|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||P-value for Change from Baseline (within group)|t-test, 2 sided|paired t-test||||||<0.0001
72461370|NCT00422162|144445427|SUPERIORITY_OR_OTHER|||||||0.28||95.0||||P-value for Change from Baseline (within group)|t-test, 2 sided|paired t-test||||||0.28
72461371|NCT02342275|144445470|NON_INFERIORITY|Assuming that the atenolol on the propranolol response rate does not fall by greater than 15%, the noninferiority margin was selected to be -15%.|Odds Ratio (OR)|0.15|||<|0.05|TWO_SIDED|95.0|||||Mixed Models Analysis||Treatment Difference=Propranolol vs Atenolol|The sample size required to compare propranolol and atenolol at month 6 was calculated before enrollment. Assuming the ulceration rate in both groups to be 10%, a sample size of180 patients was required for each group to show the noninferiority ofatenolol treatment with a 2-sidedα level of .05 and approximately 90% power||||<0.05
72461372|NCT04908800|144445478|EQUIVALENCE|Study was not powered and confidence intervals were assessed for containing unity (1) within them.|Ratio of geometric least squares mean|1.88|||||TWO_SIDED|90.0|1.74|2.04|||||"Data were analyzed using a mixed model which included actual treatment as fixed effect and participant as a random effect.~Within-subject coefficient of variation was 10.7."|||2.04|1.74|
72621065|NCT02732145|144773172|EQUIVALENCE|Question: Is there a difference in the score for Marinoff Index in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||0.9248|||||||Wilcoxon (Mann-Whitney)|||Parameter: The difference in the score for Marinoff Index (median) in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology.||||0.9248
72621066|NCT02732145|144773172|EQUIVALENCE|Question: Is there a difference in the score for the Cotton-Swab test in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||0.9839|||||||Wilcoxon (Mann-Whitney)|||Parameter: The difference in the score for the Cotton-Swab test (median) in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology.||||0.9839
72392827|NCT01603056|144293224|SUPERIORITY_OR_OTHER|||||||0.497|TWO_SIDED||||||t-test, 2 sided|||||||0.497
72392828|NCT01603056|144293225|SUPERIORITY_OR_OTHER|||||||0.222|TWO_SIDED||||||t-test, 2 sided|||||||0.222
72392829|NCT01603056|144293226|SUPERIORITY_OR_OTHER|||||||0.438|TWO_SIDED||||||Fisher Exact|||||||0.438
72461373|NCT04908800|144445479|EQUIVALENCE|Study was not powered and confidence intervals were assessed for containing unity (1) within them.|Ratio of geometric least squares mean|1.68|||||TWO_SIDED|90.0|1.57|1.79|||||"Data were analyzed using a mixed model which included actual treatment as fixed effect and participant as a random effect.~Within-subject coefficient of variation was 9.01."|||1.79|1.57|
72461374|NCT04908800|144445480|EQUIVALENCE|Study was not powered and confidence intervals were assessed for containing unity (1) within them.|Ratio of geometric least squares mean|1.15|||||TWO_SIDED|90.0|1.09|1.21|||||Data were analyzed using a mixed model which included actual treatment as fixed effect and participant as a random effect. Within-subject coefficient of variation was 7.18.|||1.21|1.09|
72461375|NCT04908800|144445485|EQUIVALENCE|Study was not powered and confidence intervals were assessed for containing unity (1) within them.|Slope|0.971|||||TWO_SIDED|95.0|0.882|1.06|||||Between-subject geometric coefficient of variation was 26.1. Data were analyzed using a power model.|Dose Proportionality Assessment||1.06|0.882|
72461376|NCT04908800|144445485|EQUIVALENCE|Study was not powered and confidence intervals were assessed for containing unity (1) within them.|Ratio of geometric least squares mean|1.01|||||TWO_SIDED|95.0|0.926|1.11|||||Geometric least squares mean was 600 (fasted) and 607 (fed). Within-subject coefficient of variation was 6.01. Data were analyzed using mixed model which included actual treatment as fixed effect and participant as a random effect.|Food Effect Assessment||1.11|0.926|
72501576|NCT04996797|144533047|SUPERIORITY||Risk Difference (RD)|33.1|||<|0.0001||95.0|17.2|46.8|||Cochran-Mantel-Haenszel|P-value is computed using Cochran-Mantel Haenszel (CMH) test with stratification factors of biologic status and CDx status.|95% CI is estimated using Newcombe method for risk difference.|||46.8|17.2|<0.0001
72501577|NCT04996797|144533048|SUPERIORITY||Risk Difference (RD)|19.6||||||95.0|-1.7|38.7|||||95% CI is estimated using Newcombe method for risk difference.|||38.7|-1.7|
72501578|NCT00741819|144533169|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|16.0|STANDARD_DEVIATION|35.9|<|0.001||95.0|||||Wilcoxon signed rank test]||Change in 6MWD from Baseline was calculated for patients still remaining on study at Week 12.|Analysis of endpoints was descriptive in nature. Numeric endpoints for post-baseline assessments were compared to Baseline using Wilcoxon signed rank test, and p-values were calculated for descriptive purposes; no formal hypothesis testing was planned.||||<0.001
72501579|NCT00741819|144533170|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.4|STANDARD_DEVIATION|7.7|<|0.001|||||||Wilcoxon signed rank test||Analysis based on Total CAMPHOR Score.|||||<0.001
72501580|NCT00741819|144533171|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5|STANDARD_DEVIATION|21.3||0.895||95.0|||||Wilcoxon signed-rank test||Side-Effects Score, change from Baseline to Week 12|||||0.895
72501581|NCT00741819|144533171|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|38.3|STANDARD_DEVIATION|25.9|<|0.001||95.0|||||Wilcoxon signed-rank test||Convenience Score, change from Baseline to Week 12|||||<0.001
72501582|NCT00741819|144533171|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|20.0|STANDARD_DEVIATION|23.7|<|0.001||95.0|||||Wilcoxon signed-rank test||Global Satisfaction, change from Baseline to Week 12|||||<0.001
72392830|NCT01603056|144293227|SUPERIORITY_OR_OTHER|||||||0.465|TWO_SIDED||||||t-test, 2 sided|||||||0.465
72392831|NCT01603056|144293228|SUPERIORITY_OR_OTHER|||||||0.123|TWO_SIDED||||||t-test, 2 sided|||||||0.123
72392832|NCT01603056|144293229|SUPERIORITY_OR_OTHER|||||||0.719|TWO_SIDED||||||t-test, 2 sided|||||||0.719
72392833|NCT00420927|144293275|SUPERIORITY_OR_OTHER|||||||0.023||95.0|||||Chi-squared|P value is from Pearson's chi-square test.||||||0.023
72392834|NCT00420927|144293276|SUPERIORITY_OR_OTHER|||||||0.082||95.0|||||Regression, Logistic|||||||0.082
72392835|NCT00420927|144293277|SUPERIORITY_OR_OTHER|||||||0.28||95.0|||||Regression, Logistic|||||||0.280
72392836|NCT00420927|144293277|SUPERIORITY_OR_OTHER|||||||0.287||95.0|||||Regression, Logistic|||||||0.287
72392837|NCT00420927|144293278|SUPERIORITY_OR_OTHER|||||||0.026||95.0|||||Regression, Logistic|||||||0.026
72501583|NCT00741819|144533171|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|19.9|STANDARD_DEVIATION|21.5|<|0.001||95.0|||||Wilcoxon signed rank test||Effectiveness score, change from Baseline to Week 12|||||<0.001
72501584|NCT00741819|144533173|SUPERIORITY_OR_OTHER|||||||0.001|||||||Wilcoxon signed-rank test|||||||0.001
72501585|NCT01126580|144533176|NON_INFERIORITY_OR_EQUIVALENCE|A non-inferiority margin of 0.4% was used.|LS Mean Difference|-0.22|||<|0.001|TWO_SIDED|95.0|-0.36|-0.08||The p-value is adjusted for multiplicity using a tree-gatekeeping strategy. To determine significance, the p-value is compared to the family-wise 1-sided Type I error of 0.025. The confidence interval is not adjusted for multiplicity.|ANCOVA|||The study was designed with 90% power to detect non-inferiority of 1.5 mg LY2189265 vs Metformin on HbA1c change from baseline at the 26-week primary endpoint with a margin of 0.4%, a standard deviation of 1.3%, and a 2-sided alpha of 0.05 assuming no true difference between treatments. This corresponds to 223 participants per arm, with an assumed drop-out rate of 11%.||-0.08|-0.36|<0.001
72501586|NCT01126580|144533176|NON_INFERIORITY_OR_EQUIVALENCE|A non-inferiority margin of 0.4% was used.|LS Mean Difference|-0.15|||<|0.001|TWO_SIDED|95.0|-0.29|-0.01||The p-value is adjusted for multiplicity using a tree-gatekeeping strategy. To determine significance, the p-value is compared to the family-wise 1-sided Type I error of 0.025. The confidence interval is not adjusted for multiplicity.|ANCOVA|||||-0.01|-0.29|<0.001
72501587|NCT01126580|144533176|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.22||||0.002|TWO_SIDED|95.0|-0.36|-0.08||Tree gatekeeping strategy to control the family-wise Type I error rate was applied.|ANCOVA|||Superiority analysis.||-0.08|-0.36|0.002
72501588|NCT01126580|144533176|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.15||||0.02|TWO_SIDED|95.0|-0.29|-0.01||Tree gatekeeping strategy to control the family-wise Type I error rate was applied.|ANCOVA|||Superiority analysis.||-0.01|-0.29|0.020
72501589|NCT01126580|144533177|NON_INFERIORITY_OR_EQUIVALENCE|A non-inferiority margin of 0.4% was used.|LS Mean Difference|-0.19|||<|0.001|TWO_SIDED|95.0|-0.35|-0.02||The p-value is adjusted for multiplicity using a tree-gatekeeping strategy. To determine significance, the p-value is compared to the family-wise 1-sided Type I error of 0.025. The confidence interval is not adjusted for multiplicity.|ANCOVA|||||-0.02|-0.35|<0.001
72461377|NCT04908800|144445485|EQUIVALENCE|Study was not powered and confidence intervals were assessed for containing unity (1) within them.|Ratio of geometric least squares mean|1.06|||||TWO_SIDED|95.0|0.701|1.59|||||Geometric least squares mean was 600 (fasted male) and 634 (fasted female). Between subject coefficient of variation was 32.7. Data were analyzed using an ANOVA model which included actual treatment as a factor.|Sex Effect Assessment||1.59|0.701|
72461378|NCT04908800|144445486|EQUIVALENCE|Study was not powered and confidence intervals were assessed for containing unity (1) within them.|Slope|0.977|||||TWO_SIDED|95.0|0.891|1.06|||||Between-subject geometric coefficient of variation was 25.4. Data were analyzed using a power model.|Dose Proportionality Assessment||1.06|0.891|
72461379|NCT04908800|144445486|EQUIVALENCE|Study was not powered and confidence intervals were assessed for containing unity (1) within them.|Ratio of geometric least squares mean|1.0|||||TWO_SIDED|95.0|0.905|1.12|||||"Geometric least squares mean was 575 (fasted) and 578 (fed). Within-subject coefficient of variation was 7.05.~Data were analyzed using mixed model which included actual treatment as fixed effect and participant as a random effect."|Food Effect Assessment||1.12|0.905|
72461380|NCT04908800|144445486|EQUIVALENCE|Study was not powered and confidence intervals were assessed for containing unity (1) within them.|Ratio of geometric least squares mean|1.04|||||TWO_SIDED|95.0|0.707|1.54|||||"Geometric least squares mean was 575 (fasted male) and 600 (fasted female). Between subject coefficient of variation was 31.1.~Data were analyzed using an ANOVA model which included actual treatment as a factor."|Sex Effect Assessment||1.54|0.707|
72461381|NCT04908800|144445487|EQUIVALENCE|Study was not powered and confidence intervals were assessed for containing unity (1) within them.|Slope|0.989|||||TWO_SIDED|95.0|0.909|1.07|||||Between-subject geometric coefficient of variation was 23.0. Data were analyzed using a power model.|Dose Proportionality Assessment||1.07|0.909|
72461382|NCT04908800|144445487|EQUIVALENCE|Study was not powered and confidence intervals were assessed for containing unity (1) within them.|Ratio of geometric least squares mean|0.948|||||TWO_SIDED|95.0|0.824|1.09|||||"Geometric least squares mean was 31.6 (fasted) and 30.0 (fed). Within-subject coefficient of variation was 9.44.~Data were analyzed using mixed model which included actual treatment as fixed effect and participant as a random effect."|Food Effect Assessment||1.09|0.824|
72461383|NCT04908800|144445487|EQUIVALENCE|Study was not powered and confidence intervals were assessed for containing unity (1) within them.|Ratio of geometric least squares mean|1.23|||||TWO_SIDED|95.0|0.928|1.62|||||"Geometric least squares mean was 31.6 (fasted male) and 38.8 (fasted female). Between subject coefficient of variation was 22.0.~Data were analyzed using an ANOVA model which included actual treatment as a factor."|Sex Effect Assessment||1.62|0.928|
72461384|NCT04908800|144445492|EQUIVALENCE|Study was not powered and confidence intervals were assessed for containing unity (1) within them.|Slope|1.11|||||TWO_SIDED|95.0|0.966|1.26|||||Between-subject geometric coefficient of variation was 26.9. Data were analyzed using a power model.|"Dose Proportionality Assessment. KRP-A218 assessed across the following dose levels: 2 mg, 4 mg, 8 mg, and 11 mg.~Dose proportionality results for Part B are only for the Day 14 profile (not Day 1)."||1.26|0.966|
72461385|NCT04908800|144445494|EQUIVALENCE|Study was not powered and confidence intervals were assessed for containing unity (1) within them.|Slope|1.12|||||TWO_SIDED|95.0|0.945|1.29|||||Between-subject geometric coefficient of variation was 32.1. Data were analyzed using a power model.|"Dose Proportionality Assessment. KRP-A218 assessed across the following dose levels: 2 mg, 4 mg, 8 mg, and 11 mg.~Dose proportionality results for Part B are only for the Day 14 profile (not Day 1)."||1.29|0.945|
72461386|NCT04908800|144445495|EQUIVALENCE|Study was not powered and confidence intervals were assessed for containing unity (1) within them.|Slope|1.1|||||TWO_SIDED|95.0|0.971|1.23|||||Between-subject geometric of coefficient variation was 23.2. Data were analyzed using a power model.|"Dose Proportionality Assessment. KRP-A218 assessed across the following dose levels: 2 mg, 4 mg, 8 mg, and 11 mg.~Dose proportionality results for Part B are only for the Day 14 profile (not Day 1)."||1.23|0.971|
72461387|NCT05045638|144445511|OTHER||Ratio of GLSMs|1.6999|||||TWO_SIDED|90.0|1.186|2.4363||||||The ratios of geometric least squares means (GLSMs) and confidence intervals (CIs) were obtained by taking the exponential of the corresponding differences and CIs on the natural-log (ln) scale.||2.4363|1.1860|
72461388|NCT05045638|144445512|OTHER||Ratio of GLSMs|1.3389|||||TWO_SIDED|90.0|1.0334|1.7347||||||The ratios of GLSMs and CIs were obtained by taking the exponential of the corresponding differences and CIs on the ln scale.||1.7347|1.0334|
72461389|NCT05045638|144445513|OTHER||Ratio of GLSMs|1.3382|||||TWO_SIDED|90.0|0.9856|1.8169||||||The ratios of GLSMs and CIs were obtained by taking the exponential of the corresponding differences and CIs on the ln scale.||1.8169|0.9856|
72461390|NCT02032420|144445519|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Repeated-measures MANOVA|The reported p value is for the effect of group assignment across three iterations of the assigned task.||||||<0.001
72461391|NCT02032420|144445520|SUPERIORITY_OR_OTHER|||||||0.004|TWO_SIDED||||||Repeated-measures MANOVA|The p value is for the effect of group assignment across three iterations of the assigned task.||||||0.004
72461392|NCT02032420|144445521|SUPERIORITY_OR_OTHER|||||||0.038|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.038
72461393|NCT02032420|144445522|SUPERIORITY_OR_OTHER|||||||0.003|TWO_SIDED||||||Fisher Exact|||||||0.003
72461394|NCT00141271|144445610|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6409||||||Hochberg's adjustment was used for multiple comparisons adjustment|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 1||||0.6409
72461395|NCT00141271|144445610|SUPERIORITY_OR_OTHER_LEGACY|||||||0.014||||||Hochberg's adjustment used for multiple comparisons adjustment|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 1||||0.0140
72461396|NCT00141271|144445610|SUPERIORITY_OR_OTHER_LEGACY|||||||0.484||||||Hochberg's adjustment used for multiple comparisons adjustment|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 2||||0.4840
72461397|NCT00141271|144445610|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4444||||||Hochberg's adjustment used for multiple comparisons adjustment|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 2||||0.4444
72461398|NCT00141271|144445610|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8129||||||Hochberg's adjustment used for multiple comparisons adjustment|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 3||||0.8129
72563520|NCT01844531|144658287|SUPERIORITY_OR_OTHER||Adjusted gMean ratio FDC/single tablets|102.77|STANDARD_ERROR_OF_MEAN|6.5||0|TWO_SIDED|90.0|99.146|106.522|||ANOVA||\*Results reported as Standard Error of the mean are Intra-individual geometric coefficient of variation \[%\].|Adjusted by-treatment geometric means and relative bioavailability comparison FDC Empa5 : Empa5 + Met500, PK set AUClast \[nmol\*h/L\] for EMPAGLIFLOZIN (PLASMA EDTA)||106.522|99.146|0.0000
72563521|NCT01844531|144658287|SUPERIORITY_OR_OTHER||Adjusted gMean ratio FDC/single tablets|102.49|STANDARD_ERROR_OF_MEAN|6.5|<|0.0001|TWO_SIDED|90.0|98.85|106.25|||ANOVA||\*Results reported as Standard Error of the mean are Intra-individual geometric coefficient of variation \[%\].|Adjusted by-treatment geometric means and relative bioavailability - analysis with fixed effects for all terms comparison FDC Empa5 : Empa5 + Met500, PK set AUClast \[nmol\*h/L\] for EMPAGLIFLOZIN (PLASMA EDTA)||106.25|98.85|<.0001
72563522|NCT01844531|144658288|SUPERIORITY_OR_OTHER||Adjusted gMean ratio FDC/single tablets|104.61|STANDARD_ERROR_OF_MEAN|8.4||0|TWO_SIDED|90.0|99.882|109.555|||ANOVA||\*Results reported as Standard Error of the mean are Intra-individual geometric coefficient of variation \[%\].|Adjusted by-treatment geometric means and relative bioavailability comparison FDC Empa12.5 : Empa12.5 + Met500, PK set Cmax \[nmol/L\] for EMPAGLIFLOZIN (PLASMA EDTA)||109.555|99.882|0.0000
72563523|NCT01844531|144658288|SUPERIORITY_OR_OTHER||Adjusted gMean ratio FDC/single tablets|104.53|STANDARD_ERROR_OF_MEAN|8.4|<|0.0001|TWO_SIDED|90.0|99.76|109.53|||ANOVA||\*Results reported as Standard Error of the mean are Intra-individual geometric coefficient of variation \[%\].|Adjusted by-treatment geometric means and relative bioavailability - analysis with fixed effects for all terms comparison FDC Empa12.5 : Empa12.5 + Met500, PK set Cmax \[nmol/L\] for EMPAGLIFLOZIN (PLASMA EDTA)||109.53|99.76|<.0001
72563524|NCT01844531|144658288|SUPERIORITY_OR_OTHER||Adjusted gMean ratio FDC/single tablets|102.96|STANDARD_ERROR_OF_MEAN|9.2||0|TWO_SIDED|90.0|97.917|108.258|||ANOVA||\*Results reported as Standard Error of the mean are Intra-individual geometric coefficient of variation \[%\].|Adjusted by-treatment geometric means and relative bioavailability comparison FDC Empa5 : Empa5 + Met500, PK set Cmax \[nmol/L\] for EMPAGLIFLOZIN (PLASMA EDTA)||108.258|97.917|0.0000
72461399|NCT00141271|144445610|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1105||||||Hochberg's adjustment used for multiple comparisons adjustment|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 3||||0.1105
72461400|NCT00141271|144445610|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9582||||||Hochberg's adjustment used for multiple comparisons adjustment|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 4||||0.9582
72461401|NCT00141271|144445610|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1893||||||Hochberg's adjustment used for multiple comparisons adjustment|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 4||||0.1893
72461402|NCT00141271|144445610|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2924||||||Hochberg's adjustment used for multiple comparisons adjustment|Mixed Models Analysis|Hochberg's adjustment used for multiple comparisons adjustment||Week 5||||0.2924
72461403|NCT00141271|144445610|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1897||||||Hochberg's adjustment used for multiple comparisons adjustment|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 5||||0.1897
72461404|NCT00141271|144445610|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6608||||||Hochberg's adjustment used for multiple comparisons adjustment|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||"Week 6 An estimated sample size of 180 was needed per treatment arm in order to achieve 85% power to detect a treatment difference of 3.5 in the mean change from baseline to Week 6 in MADRS total score with a two-sided t-test at the 0.05 significance level. The common standard deviation was estimated as 11.0.~The null hypotheses for the primary parameter is equality of mean change from baseline to Week 6 in MADRS total score between ziprasidone and placebo groups."||||0.6608
72461405|NCT00141271|144445610|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2148||||||Hochberg's adjustment used for multiple comparisons adjustment|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||"Week 6 An estimated sample size of 180 was needed per treatment arm in order to achieve 85% power to detect a treatment difference of 3.5 in the mean change from baseline to Week 6 in MADRS total score with a two-sided t-test at the 0.05 significance level. The common standard deviation was estimated as 11.0.~The null hypotheses for the primary parameter is equality of mean change from baseline to Week 6 in MADRS total score between ziprasidone and placebo groups."||||0.2148
72461406|NCT00141271|144445610|SUPERIORITY_OR_OTHER_LEGACY|||||||0.529||||||Hochberg's adjustment used for multiple comparisons adjustment|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Overall||||0.5290
72461407|NCT00141271|144445610|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0811||||||Hochberg's adjustment used for multiple comparisons adjustment|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Overall||||0.0811
72461408|NCT00141271|144445611|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2287||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 1||||0.2287
72461409|NCT00141271|144445611|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4734||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week1||||0.4734
72461410|NCT00141271|144445611|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7401||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 2||||0.7401
72392838|NCT00420927|144293278|SUPERIORITY_OR_OTHER|||||||0.009||95.0|||||Regression, Logistic|||||||0.009
72392839|NCT00420927|144293279|SUPERIORITY_OR_OTHER|||||||0.06||95.0|||||Regression, Logistic|||||||0.060
72392840|NCT00420927|144293279|SUPERIORITY_OR_OTHER|||||||0.063||95.0|||||Regression, Logistic|||||||0.063
72392841|NCT00420927|144293280|SUPERIORITY_OR_OTHER|||||||0.395||95.0|||||Regression, Logistic|||||||0.395
72392842|NCT00420927|144293280|SUPERIORITY_OR_OTHER|||||||0.64||95.0|||||Regression, Logistic|||||||0.640
72392843|NCT00420927|144293281|SUPERIORITY_OR_OTHER|||||||0.159||95.0|||||Regression, Logistic|||||||0.159
72392844|NCT00420927|144293281|SUPERIORITY_OR_OTHER|||||||0.217||95.0|||||Regression, Logistic|||||||0.217
72392845|NCT00420927|144293282|SUPERIORITY_OR_OTHER|||||||0.06||95.0|||||Regression, Logistic|||||||0.060
72392846|NCT00420927|144293282|SUPERIORITY_OR_OTHER|||||||0.043||95.0|||||Regression, Logistic|||||||0.043
72392847|NCT00420927|144293283|SUPERIORITY_OR_OTHER|||||||0.004||95.0|||||ANCOVA|Analysis of covariance adjusting for baseline||||||0.004
72461411|NCT00141271|144445611|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7904||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 2||||0.7904
72461412|NCT00141271|144445611|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5274||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 3||||0.5274
72461413|NCT00141271|144445611|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1059||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 3||||0.1059
72461414|NCT00141271|144445611|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8871||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 4||||0.8871
72461415|NCT00141271|144445611|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6939|||||||Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 4||||0.6939
72392848|NCT00420927|144293283|SUPERIORITY_OR_OTHER|||||||0.049||95.0|||||ANCOVA|Analysis of covariance adjusting for baseline||||||0.049
72392849|NCT00420927|144293284|SUPERIORITY_OR_OTHER|||||||0.24||95.0|||||Regression, Logistic|||||||0.240
72392850|NCT00420927|144293284|SUPERIORITY_OR_OTHER|||||||0.271||95.0|||||Regression, Logistic|||||||0.271
72392851|NCT00420927|144293285|SUPERIORITY_OR_OTHER|||||||0.23||95.0|||||Regression, Logistic|||||||0.230
72392852|NCT00420927|144293285|SUPERIORITY_OR_OTHER|||||||0.55||95.0|||||Regression, Logistic|||||||0.550
72392853|NCT00420927|144293286|SUPERIORITY_OR_OTHER|||||||0.301||95.0|||||Regression, Logistic|||||||0.301
72392854|NCT00420927|144293286|SUPERIORITY_OR_OTHER|||||||0.188||95.0|||||Regression, Logistic|||||||0.188
72392855|NCT00420927|144293287|SUPERIORITY_OR_OTHER|||||||0.314||95.0|||||Regression, Logistic|||||||0.314
72392856|NCT00420927|144293287|SUPERIORITY_OR_OTHER|||||||0.235||95.0|||||Regression, Logistic|||||||0.235
72392857|NCT00420927|144293288|SUPERIORITY_OR_OTHER|||||||0.03||95.0|||||ANCOVA|Analysis of covariance adjusting for baseline||||||0.030
72392858|NCT00420927|144293288|SUPERIORITY_OR_OTHER|||||||0.403||95.0|||||ANCOVA|Analysis of covariance adjusting for baseline||||||0.403
72392859|NCT00420927|144293289|SUPERIORITY_OR_OTHER|||||||0.036||95.0|||||ANCOVA|Analysis of covariance adjusting for baseline||||||0.036
72392860|NCT00420927|144293289|SUPERIORITY_OR_OTHER|||||||0.349||95.0|||||ANCOVA|Analysis of covariance adjusting for baseline||||||0.349
72392861|NCT00420927|144293290|SUPERIORITY_OR_OTHER|||||||0.037||95.0|||||ANCOVA|Analysis of covariance adjusting for baseline||||||0.037
72392862|NCT00420927|144293290|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|Analysis of covariance adjusting for baseline||||||<0.001
72392863|NCT00420927|144293291|SUPERIORITY_OR_OTHER|||||||0.192||95.0|||||Regression, Logistic|||||||0.192
72392864|NCT00420927|144293291|SUPERIORITY_OR_OTHER|||||||0.241||95.0|||||Regression, Logistic|||||||0.241
72392865|NCT00420927|144293292|SUPERIORITY_OR_OTHER|||||||0.028||95.0|||||Regression, Logistic|||||||0.028
72392866|NCT00420927|144293292|SUPERIORITY_OR_OTHER|||||||0.014||95.0|||||Regression, Logistic|||||||0.014
72392867|NCT00420927|144293293|SUPERIORITY_OR_OTHER|||||||0.074||95.0|||||Regression, Logistic|||||||0.074
72392868|NCT00420927|144293293|SUPERIORITY_OR_OTHER|||||||0.077||95.0|||||Regression, Logistic|||||||0.077
72392869|NCT00320411|144293299|SUPERIORITY_OR_OTHER||percentage of participants|17.2||||||95.0|8.6|29.4||||||||29.4|8.6|
72392870|NCT00320411|144293301|SUPERIORITY_OR_OTHER||percentage of participants|32.3||||||95.0|20.0|44.7||||||||44.7|20.0|
72392871|NCT00320411|144293302|SUPERIORITY_OR_OTHER||percentage of participants|22.8||||||95.0|11.6|34.0||||||||34.0|11.6|
72392872|NCT02557646|144293325|SUPERIORITY_OR_OTHER|||||||0.0437|TWO_SIDED||||||Chi-squared|||Cumulative dose of ribavirin \>90%: the relationship between cumulative dose and SVR response in participants in whom the cumulative dose of ribavirin exceeded 90% was analyzed using Chi-square test.||||0.0437
72392873|NCT02557646|144293327|SUPERIORITY_OR_OTHER|||||||0.6859|TWO_SIDED||||||Chi-squared|||The relationship between the starting dose ribavirin and virological response was analyzed using Chi-square test.||||0.6859
72392874|NCT02557646|144293328|SUPERIORITY_OR_OTHER|||||||0.374|TWO_SIDED||||||Chi-squared|||The relationship between the starting dose ribavirin and sustained virological response (SVR) was analyzed using Chi-square test.||||0.3740
72392875|NCT02557646|144293329|SUPERIORITY_OR_OTHER|||||||0.0263|TWO_SIDED||||||Chi-squared, Corrected|||The relationship between the body weight-normalized dose of ribavirin and virological response was analyzed using Chi-square test.||||0.0263
72392876|NCT02557646|144293330|SUPERIORITY_OR_OTHER|||||||0.0475|TWO_SIDED||||||Chi-squared|||The relationship between the body weight-normalized dose of ribavirin and sustained virological (SVR) response was analyzed using Chi-square test.||||0.0475
72392877|NCT02557646|144293336|SUPERIORITY_OR_OTHER|||||||0.1499|TWO_SIDED||||||Chi-squared|||The relationship between the cumulative dose of ribavirin and relapse rate was analyzed using Chi-square test.||||0.1499
72461416|NCT00141271|144445611|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1044||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 5||||0.1044
72461417|NCT00141271|144445611|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3132||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 5||||0.3132
72461418|NCT00141271|144445611|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6978||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 6||||0.6978
72461419|NCT00141271|144445611|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3228||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 6||||0.3228
72461420|NCT00141271|144445611|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6432||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Endpoint||||0.6432
72461421|NCT00141271|144445611|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5989||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Endpoint||||0.5989
72461422|NCT00141271|144445612|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8921||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 3||||0.8921
72461423|NCT00141271|144445612|SUPERIORITY_OR_OTHER_LEGACY|||||||0.435||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 3||||0.4350
72461424|NCT00141271|144445612|SUPERIORITY_OR_OTHER_LEGACY|||||||0.562||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 6||||0.5620
72461425|NCT00141271|144445612|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6959||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 6||||0.6959
72461426|NCT00141271|144445612|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7865||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Endpoint||||0.7865
72461427|NCT00141271|144445612|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7564||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Endpoint||||0.7564
72461428|NCT00141271|144445613|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4327||||||For all efficacy analyses, no multiple comparisons adjustments were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint||||0.4327
72461429|NCT00141271|144445613|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7041||||||For all efficacy analyses, no multiple comparisons adjustments were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint||||0.7041
72461430|NCT00141271|144445614|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2076||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 1||||0.2076
72461431|NCT00141271|144445614|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7449||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 1||||0.7449
72461432|NCT00141271|144445614|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4399||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 2||||0.4399
72461433|NCT00141271|144445614|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7107||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 2||||0.7107
72461434|NCT00141271|144445614|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4765||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 3||||0.4765
72461435|NCT00141271|144445614|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2564||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 3||||0.2564
72461436|NCT00141271|144445614|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8063||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 4||||0.8063
72461437|NCT00141271|144445614|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9855||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 4||||0.9855
72621067|NCT02732145|144773172|EQUIVALENCE|Question: Is there a difference in the score for any lesion in any vulvar ring (median) in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||0.5124|||||||Wilcoxon (Mann-Whitney)|||Parameter: The difference in the score for any lesion in any vulvar ring (median) in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology.||||0.5124
72621068|NCT02732145|144773172|EQUIVALENCE|Question: Is there a difference in the score for any vulvar lesion of the Outer Vulvar Ring in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||0.2058|||||||Wilcoxon (Mann-Whitney)|||Parameter: The difference in the score for any vulvar lesion of the Outer Vulvar Ring (median) in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology.||||0.2058
72461438|NCT00141271|144445614|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0599||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 5||||0.0599
72461439|NCT00141271|144445614|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7364||||||For all secondary efficacy analyses, no multiple comparison adjustment were made.|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 5||||0.7364
72461440|NCT00141271|144445614|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3048||||||For all secondary efficacy analyses, no multiple comparison adjustment were made.|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups.||Week 6||||0.3048
72461441|NCT00141271|144445614|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5139||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups.||Week 6||||0.5139
72461442|NCT00141271|144445614|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9356||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Endpoint||||0.9356
72461443|NCT00141271|144445614|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9428||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Endpoint||||0.9428
72461444|NCT00141271|144445615|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3888||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 3||||0.3888
72461445|NCT00141271|144445615|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3122||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 3||||0.3122
72461446|NCT00141271|144445615|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3323||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 6||||0.3323
72461447|NCT00141271|144445615|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8781||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 6||||0.8781
72461448|NCT00141271|144445615|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9485||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Endpoint||||0.9485
72461449|NCT00141271|144445615|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7331||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Endpoint||||0.7331
72461450|NCT00141271|144445616|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4869||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate.||Week 3||||0.4869
72461451|NCT00141271|144445616|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5813||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate.||Week 3||||0.5813
72461452|NCT00141271|144445616|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3303||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate.||Week 6||||0.3303
72461453|NCT00141271|144445616|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1546||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate.||Week 6||||0.1546
72461454|NCT00141271|144445616|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8982||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate.||Endpoint||||0.8982
72621069|NCT02732145|144773172|EQUIVALENCE|Question: Is there a difference in the score for any vulvar lesion of the Middle Vulvar Ring in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||0.6412|||||||Wilcoxon (Mann-Whitney)|||Parameter: The difference in the score for any vulvar lesion of the Middle Vulvar Ring (median) in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology.||||0.6412
72621070|NCT02732145|144773172|EQUIVALENCE|Question: Is there a difference in the score for any vulvar lesion of the Inner Vulvar Ring in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||0.9753|||||||Wilcoxon (Mann-Whitney)|||Parameter: The difference in the score for any vulvar lesion of the Inner Vulvar Ring (median) in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology.||||0.9753
72461455|NCT00141271|144445616|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3586||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint||||0.3586
72461456|NCT00141271|144445617|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0896||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Week 3||||0.0896
72461457|NCT00141271|144445617|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6534||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Week 3||||0.6534
72461458|NCT00141271|144445617|SUPERIORITY_OR_OTHER_LEGACY|||||||0.327||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Week 6||||0.3270
72461459|NCT00141271|144445617|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4099||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Week 6||||0.4099
72621071|NCT02732145|144773172|EQUIVALENCE|Question: Is there a difference in the score for the specificity of vulvar lesions in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||0.3621|||||||Wilcoxon (Mann-Whitney)|||Parameter: The difference in the score for the specificity of vulvar lesions (median) in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology.||||0.3621
72461460|NCT00141271|144445617|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6104||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint||||0.6104
72461461|NCT00141271|144445617|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9359||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint||||0.9359
72461462|NCT00141271|144445618|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6924||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 1||||0.6924
72461463|NCT00141271|144445618|SUPERIORITY_OR_OTHER_LEGACY|||||||0.08||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 1||||0.0800
72461464|NCT00141271|144445618|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4238||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 2||||0.4238
72501590|NCT01126580|144533177|NON_INFERIORITY_OR_EQUIVALENCE|A non-inferiority margin of 0.4% was used.|LS Mean Difference|-0.04|||<|0.001|TWO_SIDED|95.0|-0.2|0.12||The p-value is adjusted for multiplicity using a tree-gatekeeping strategy. To determine significance, the p-value is compared to the family-wise 1-sided Type I error of 0.025. The confidence interval is not adjusted for multiplicity.|ANCOVA|||||0.12|-0.20|<0.001
72501591|NCT01126580|144533177|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.19||||0.024|TWO_SIDED|95.0|-0.35|-0.02||Tree gatekeeping strategy to control the family-wise Type I error rate was applied.|ANCOVA|||Superiority analysis.||-0.02|-0.35|0.024
72461465|NCT00141271|144445618|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7714||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 2||||0.7714
72461466|NCT00141271|144445618|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8731||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 3||||0.8731
72461467|NCT00141271|144445618|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8926||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 3||||0.8926
72461468|NCT00141271|144445618|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2072||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 4||||0.2072
72501592|NCT01126580|144533177|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.04||||0.299|TWO_SIDED|95.0|-0.2|0.12||Tree gatekeeping strategy to control the family-wise Type I error rate was applied.|ANCOVA|||Superiority analysis.||0.12|-0.20|0.299
72461469|NCT00141271|144445618|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1042||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 4||||0.1042
72461470|NCT00141271|144445618|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2695||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 5||||0.2695
72461471|NCT00141271|144445618|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3245||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 5||||0.3245
72461472|NCT00141271|144445618|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7791||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 6||||0.7791
72461473|NCT00141271|144445618|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0999||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 6||||0.0999
72461474|NCT00141271|144445618|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9543||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Overall||||0.9543
72461475|NCT00141271|144445618|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3153||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Overall||||0.3153
72461476|NCT00141271|144445619|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2878||||||For all secondary efficacy analyses, no multiple comparison adjustment were made.|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 1||||0.2878
72461477|NCT00141271|144445619|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4481||||||For all secondary efficacy analyses, no multiple comparison adjustment were made.|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 1||||0.4481
72461478|NCT00141271|144445619|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4099||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 2||||0.4099
72461479|NCT00141271|144445619|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5093||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value.||Week 2||||0.5093
72461480|NCT00141271|144445619|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8048||||||For all secondary efficacy analyses, no multiple comparison adjustment were made.|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value.||Week 3||||0.8048
72461481|NCT00141271|144445619|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0552||||||For all secondary efficacy analyses, no multiple comparison adjustment were made.|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 3||||0.0552
72461482|NCT00141271|144445619|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9795||||||For all secondary efficacy analyses, no multiple comparison adjustment were made.|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 4||||0.9795
72461483|NCT00141271|144445619|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5073||||||For all secondary efficacy analyses, no multiple comparison adjustment were made.|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 4||||0.5073
72461484|NCT00141271|144445619|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4882||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 5||||0.4882
72461485|NCT00141271|144445619|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3967||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 5||||0.3967
72461486|NCT00141271|144445619|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8276||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 6||||0.8276
72461487|NCT00141271|144445619|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8502||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 6||||0.8502
72461488|NCT00141271|144445619|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6343||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Overall||||0.6343
72461489|NCT00141271|144445619|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3082||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Overall||||0.3082
72501593|NCT01126580|144533178|SUPERIORITY_OR_OTHER|||||||0.023||||||Treatment comparison for HbA1c less than 7.0% at 26 weeks.|Regression, Logistic|||||||0.023
72461490|NCT00141271|144445620|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6932||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 1||||0.6932
72461491|NCT00141271|144445620|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0287||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 1||||0.0287
72461492|NCT00141271|144445620|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2128||95.0||||For all secondary efficacy analyses, no multiple comparison adjustment were made.|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 2||||0.2128
72461493|NCT00141271|144445620|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1118||||||For all secondary efficacy analyses, no multiple comparison adjustment were made.|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 2||||0.1118
72461494|NCT00141271|144445620|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6144||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 3||||0.6144
72461495|NCT00141271|144445620|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0899||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 3||||0.0899
72461496|NCT00141271|144445620|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8819||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 4||||0.8819
72461497|NCT00141271|144445620|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8374||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 4||||0.8374
72461498|NCT00141271|144445620|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3925||||||For all secondary efficacy analyses, no multiple comparison adjustment were made.|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 5||||0.3925
72461499|NCT00141271|144445620|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4182||||||For all secondary efficacy analyses, no multiple comparison adjustment were made.|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 5||||0.4182
72461500|NCT00141271|144445620|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8586||||||For all secondary efficacy analyses, no multiple comparison adjustment were made.|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 6||||0.8586
72461501|NCT00141271|144445620|SUPERIORITY_OR_OTHER_LEGACY|||||||0.549||||||For all secondary efficacy analyses, no multiple comparison adjustment were made.|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 6||||0.5490
72461502|NCT00141271|144445620|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6292||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Overall||||0.6292
72461503|NCT00141271|144445620|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1473||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Overall||||0.1473
72501594|NCT01126580|144533178|SUPERIORITY_OR_OTHER|||||||0.021||||||Treatment comparison for HbA1c less than 7.0% at 26 weeks.|Regression, Logistic|||||||0.021
72461504|NCT00141271|144445621|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2058||||||For all efficacy analyses, no multiple comparisons adjustments were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Week 3||||0.2058
72461505|NCT00141271|144445621|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9254||||||For all efficacy analyses, no multiple comparisons adjustments were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Week 3||||0.9254
72461506|NCT00141271|144445621|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5071||||||For all efficacy analyses, no multiple comparisons adjustments were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Week 6||||0.5071
72461507|NCT00141271|144445621|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2858||||||For all efficacy analyses, no multiple comparisons adjustments were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Week 6||||0.2858
72461508|NCT00141271|144445621|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6298||||||For all efficacy analyses, no multiple comparisons adjustments were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint||||0.6298
72501595|NCT01126580|144533178|SUPERIORITY_OR_OTHER||||||<|0.001||||||Treatment comparison for HbA1c less than or equal to 6.5% at 26 weeks.|Regression, Logistic|||||||<0.001
72501596|NCT01126580|144533178|SUPERIORITY_OR_OTHER|||||||0.011||||||Treatment comparison for HbA1c less than or equal to 6.5% at 26 weeks.|Regression, Logistic|||||||0.011
72461509|NCT00141271|144445621|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6034||||||For all efficacy analyses, no multiple comparisons adjustments were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint||||0.6034
72461510|NCT00141271|144445622|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1454||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 1||||0.1454
72461511|NCT00141271|144445622|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2672||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups.||Week 1||||0.2672
72461512|NCT00141271|144445622|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2614||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups.||Week 2||||0.2614
72461513|NCT00141271|144445622|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2143||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 2||||0.2143
72461514|NCT00141271|144445622|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6997||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 3||||0.6997
72461515|NCT00141271|144445622|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0128||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 3||||0.0128
72461516|NCT00141271|144445622|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1144||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 4||||0.1144
72461517|NCT00141271|144445622|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1483||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 4||||0.1483
72461518|NCT00141271|144445622|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0674||||||For all secondary efficacy analyses, no multiple comparison adjustment were made.|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 5||||0.0674
72461519|NCT00141271|144445622|SUPERIORITY_OR_OTHER_LEGACY|||||||0.29||||||For all secondary efficacy analyses, no multiple comparison adjustment were made.|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 5||||0.2900
72461520|NCT00141271|144445622|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5482||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 6||||0.5482
72461521|NCT00141271|144445622|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0303||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 6||||0.0303
72461522|NCT00141271|144445622|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6143||||||For all secondary efficacy analyses, no multiple comparison adjustment were made.|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Endpoint||||0.6143
72461523|NCT00141271|144445622|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3385||||||For all secondary efficacy analyses, no multiple comparison adjustment were made.|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Endpoint||||0.3385
72461524|NCT00141271|144445623|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3299||||||For all secondary efficacy analyses, no multiple comparison adjustment were made.|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint||||0.3299
72461525|NCT00141271|144445623|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1915||||||For all secondary efficacy analyses, no multiple comparison adjustment were made.|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint||||0.1915
72461526|NCT00141271|144445624|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5407||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint||||0.5407
72461527|NCT00141271|144445624|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6079||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint||||0.6079
72461528|NCT00141271|144445625|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8464||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Week 3||||0.8464
72461529|NCT00141271|144445625|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4023||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Week 3||||0.4023
72501597|NCT01126580|144533178|SUPERIORITY_OR_OTHER|||||||0.001||||||Treatment comparison for HbA1c less than 7% at 52 weeks.|Regression, Logistic|||||||0.001
72501598|NCT01126580|144533178|SUPERIORITY_OR_OTHER|||||||0.269||||||Treatment comparison for HbA1c less than 7% at 52 weeks.|Regression, Logistic|||||||0.269
72501599|NCT01126580|144533178|SUPERIORITY_OR_OTHER||||||<|0.001||||||Treatment comparison for HbA1c less than or equal to 6.5% at 52 weeks.|Regression, Logistic|||||||<0.001
72501600|NCT01126580|144533178|SUPERIORITY_OR_OTHER|||||||0.134||||||Treatment comparison for HbA1c less than or equal to 6.5% at 52 weeks.|Regression, Logistic|||||||0.134
72501601|NCT01126580|144533179|SUPERIORITY_OR_OTHER|||||||0.079||||||Treatment comparison at 26 weeks.|Mixed Models Analysis|||||||0.079
72501602|NCT01126580|144533179|SUPERIORITY_OR_OTHER|||||||0.451||||||Treatment comparison at 26 weeks.|Mixed Models Analysis|||||||0.451
72563525|NCT01844531|144658288|SUPERIORITY_OR_OTHER||Adjusted gMean ratio FDC/single tablets|102.8|STANDARD_ERROR_OF_MEAN|9.2|<|0.0001|TWO_SIDED|90.0|97.72|108.14|||ANOVA||\*Results reported as Standard Error of the mean are Intra-individual geometric coefficient of variation \[%\].|Adjusted by-treatment geometric means and relative bioavailability - analysis with fixed effects for all terms comparison FDC Empa5 : Empa5 + Met500, PK set Cmax \[nmol/L\] for EMPAGLIFLOZIN (PLASMA EDTA)||108.14|97.72|<.0001
72501603|NCT01126580|144533179|SUPERIORITY_OR_OTHER|||||||0.025||||||Treatment comparison at 52 weeks.|Mixed Models Analysis|||||||0.025
72563526|NCT01844531|144658289|SUPERIORITY_OR_OTHER||Adjusted gMean ratio FDC/single tablets|94.76|STANDARD_ERROR_OF_MEAN|11.4||0.0001|TWO_SIDED|90.0|89.056|100.819|||ANOVA||\*Results reported as Standard Error of the mean are Intra-individual geometric coefficient of variation \[%\].|Adjusted by-treatment geometric means and relative bioavailability comparison FDC Empa12.5 : Empa12.5 + Met500, PK set Cmax \[ng/mL\] for METFORMIN (PLASMA EDTA)||100.819|89.056|0.0001
72563527|NCT01844531|144658289|SUPERIORITY_OR_OTHER||Adjusted gMean ratio FDC/single tablets|94.4|STANDARD_ERROR_OF_MEAN|11.4||0.0001|TWO_SIDED|90.0|88.64|100.54|||ANOVA||\*Results reported as Standard Error of the mean are Intra-individual geometric coefficient of variation \[%\].|Adjusted by-treatment geometric means and relative bioavailability - analysis with fixed effects for all terms comparison FDC Empa12.5 : Empa12.5 + Met500, PK set Cmax \[ng/mL\] for METFORMIN (PLASMA EDTA)||100.54|88.64|0.0001
72563528|NCT01844531|144658289|SUPERIORITY_OR_OTHER||Adjusted gMean ratio FDC/single tablets|93.83|STANDARD_ERROR_OF_MEAN|11.9||0.0002|TWO_SIDED|90.0|88.006|100.034|||ANOVA||\*Results reported as Standard Error of the mean are Intra-individual geometric coefficient of variation \[%\].|Adjusted by-treatment geometric means and relative bioavailability comparison FDC Empa5 : Empa5 + Met500, PK set Cmax \[ng/mL\] for METFORMIN (PLASMA EDTA)||100.034|88.006|0.0002
72563529|NCT01844531|144658289|SUPERIORITY_OR_OTHER||Adjusted gMean ratio FDC/single tablets|93.98|STANDARD_ERROR_OF_MEAN|12.0||0.0003|TWO_SIDED|90.0|87.94|100.43|||ANOVA||\*Results reported as Standard Error of the mean are Intra-individual geometric coefficient of variation \[%\].|Adjusted by-treatment geometric means and relative bioavailability - analysis with fixed effects for all terms comparison FDC Empa5 : Empa5 + Met500, PK set Cmax \[ng/mL\] for METFORMIN (PLASMA EDTA)||100.43|87.94|0.0003
72563530|NCT01844531|144658290|SUPERIORITY_OR_OTHER||Adjusted gMean ratio FDC/single tablets|95.78|STANDARD_ERROR_OF_MEAN|15.7||0.0008|TWO_SIDED|90.0|88.0|104.256|||ANOVA||\*Results reported as Standard Error of the mean are Intra-individual geometric coefficient of variation \[%\].|Adjusted by-treatment geometric means and relative bioavailability comparison FDC Empa12.5 : Empa12.5 + Met500, PK set AUClast \[ng\*h/mL\] for METFORMIN (PLASMA EDTA)||104.256|88.000|0.0008
72563531|NCT01844531|144658290|SUPERIORITY_OR_OTHER||Adjusted gMean ratio FDC/single tablets|96.74|STANDARD_ERROR_OF_MEAN|15.5||0.0006|TWO_SIDED|90.0|88.78|105.41|||ANOVA||\*Results reported as Standard Error of the mean are Intra-individual geometric coefficient of variation \[%\].|Adjusted by-treatment geometric means and relative bioavailability - analysis with fixed effects for all terms comparison FDC Empa12.5 : Empa12.5 + Met500, PK set AUClast \[ng\*h/mL\] for METFORMIN (PLASMA EDTA)||105.41|88.78|0.0006
72563532|NCT01844531|144658290|SUPERIORITY_OR_OTHER||Adjusted gMean ratio FDC/single tablets|95.94|STANDARD_ERROR_OF_MEAN|9.3||0|TWO_SIDED|90.0|91.199|100.934|||ANOVA||\*Results reported as Standard Error of the mean are Intra-individual geometric coefficient of variation \[%\].|Adjusted by-treatment geometric means and relative bioavailability comparison FDC Empa5 : Empa5 + Met500, PK set AUClast \[ng\*h/mL\] for METFORMIN (PLASMA EDTA)||100.934|91.199|0.0000
72563533|NCT01844531|144658290|SUPERIORITY_OR_OTHER||Adjusted gMean ratio FDC/single tablets|96.1|STANDARD_ERROR_OF_MEAN|9.3|<|0.0001|TWO_SIDED|90.0|91.28|101.19|||ANOVA||\*Results reported as Standard Error of the mean are Intra-individual geometric coefficient of variation \[%\].|Adjusted by-treatment geometric means and relative bioavailability - analysis with fixed effects for all terms comparison FDC Empa5 : Empa5 + Met500, PK set AUClast \[ng\*h/mL\] for METFORMIN (PLASMA EDTA)||101.19|91.28|<.0001
72501604|NCT01126580|144533179|SUPERIORITY_OR_OTHER|||||||0.402||||||Treatment comparison at 52 weeks.|Mixed Models Analysis|||||||0.402
72501605|NCT01126580|144533180|SUPERIORITY_OR_OTHER|||||||0.061||||||Treatment comparison at 26 weeks.|ANCOVA|||||||0.061
72501606|NCT01126580|144533180|SUPERIORITY_OR_OTHER|||||||0.647||||||Treatment comparison at 26 weeks.|ANCOVA|||||||0.647
72501607|NCT01126580|144533180|SUPERIORITY_OR_OTHER|||||||0.022||||||Treatment comparison at 52 weeks.|ANCOVA|||||||0.022
72501608|NCT01126580|144533180|SUPERIORITY_OR_OTHER|||||||0.469||||||Treatment comparison at 52 weeks.|ANCOVA|||||||0.469
72501609|NCT01126580|144533181|SUPERIORITY_OR_OTHER|||||||0.811||||||Treatment comparison at 26 weeks.|ANCOVA|||||||0.811
72501610|NCT01126580|144533181|SUPERIORITY_OR_OTHER|||||||0.003||||||Treatment comparison at 26 weeks.|ANCOVA|||||||0.003
72501611|NCT01126580|144533181|SUPERIORITY_OR_OTHER|||||||0.44||||||Treatment comparison at 52 weeks.|ANCOVA|||||||0.440
72501612|NCT01126580|144533181|SUPERIORITY_OR_OTHER|||||||0.001||||||Treatment comparison at 52 weeks.|ANCOVA|||||||0.001
72501613|NCT01126580|144533182|SUPERIORITY_OR_OTHER|||||||0.75||||||Treatment comparison at 26 weeks.|ANCOVA|||||||0.750
72501614|NCT01126580|144533182|SUPERIORITY_OR_OTHER|||||||0.003||||||Treatment comparison at 26 weeks.|ANCOVA|||||||0.003
72501615|NCT01126580|144533182|SUPERIORITY_OR_OTHER|||||||0.412||||||Treatment comparison at 52 weeks.|ANCOVA|||||||0.412
72501616|NCT01126580|144533182|SUPERIORITY_OR_OTHER|||||||0.001||||||Treatment comparison at 52 weeks.|ANCOVA|||||||0.001
72461530|NCT00141271|144445625|SUPERIORITY_OR_OTHER_LEGACY|||||||0.287||||||For all efficacy analyses, no multiple comparisons adjustments were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Week 6||||0.2870
72461531|NCT00141271|144445625|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2537||||||For all efficacy analyses, no multiple comparisons adjustments were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Week 6||||0.2537
72461532|NCT00141271|144445625|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7909||||||For all secondary efficacy analyses, no multiple comparison adjustment were made.|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint||||0.7909
72563534|NCT02744755|144658291|EQUIVALENCE|A 0.6 change in DAS28-CRP score is considered as no clinically meaningful difference by EULAR criteria and is therefore used as the equivalence margin limits \[0.6,-0.6\].|Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.129|||TWO_SIDED|95.0|-0.24|0.27||||||Therapeutic equivalence in terms of change from baseline in DAS28-CRP at week 12 will be concluded if the 95% confidence interval for the LS mean difference between GP2017 and Humira is contained within the interval \[-0.6; 0.6\]. A mixed-model repeated measures analysis was performed for DAS28-CRP change from baseline including treatment, stratification factors, time, the interaction between time (visits) and treatment all as categorical variables, and baseline DAS28-CRP as a continuous variable.||0.27|-0.24|
72563535|NCT02744755|144658291|EQUIVALENCE|A 0.6 change in DAS28-CRP score is considered as no clinically meaningful difference by EULAR criteria and is therefore used as the equivalence margin limits \[0.6,-0.6\].|Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.129|||TWO_SIDED|90.0|-0.19|0.23||||||Therapeutic equivalence in terms of change from baseline in DAS28-CRP at week 12 will be concluded if the 90% confidence interval for the LS mean difference between GP2017 and Humira is contained within the interval \[-0.6; 0.6\]. A mixed-model repeated measures analysis was performed for DAS28-CRP change from baseline including treatment, stratification factors, time, the interaction between time (visits) and treatment all as categorical variables, and baseline DAS28-CRP as a continuous variable.||0.23|-0.19|
72563536|NCT02744755|144658292|EQUIVALENCE|A 0.6 change in DAS28-CRP score is considered as no clinically meaningful difference by EULAR criteria and is therefore used as the equivalence margin limits \[0.6,-0.6\].|Mean Difference (Final Values)|0.08|STANDARD_ERROR_OF_MEAN|0.096|||TWO_SIDED|95.0|-0.11|0.27|||ANCOVA|||ANCOVA model included treatment, body weight as per CRF, prior therapy as per CRF, region as per CRF as fixed effects and baseline DAS28-CRP values as covariate.||0.27|-0.11|
72563537|NCT02744755|144658292|EQUIVALENCE|A 0.6 change in DAS28-CRP score is considered as no clinically meaningful difference by EULAR criteria and is therefore used as the equivalence margin limits \[0.6,-0.6\].|Mean Difference (Final Values)|0.08|STANDARD_ERROR_OF_MEAN|0.096|||TWO_SIDED|90.0|-0.08|0.24|||ANCOVA|||ANCOVA model included treatment, body weight as per CRF, prior therapy as per CRF, region as per CRF as fixed effects and baseline DAS28-CRP values as covariate.||0.24|-0.08|
72563538|NCT03173170|144658314|OTHER||Mean ratio|1.0622|||||TWO_SIDED|90.0|0.9569|1.1792||||||A paired t-test on the natural log-transformed parameters was performed. The means and difference of means for the log-transformed parameters were exponentiated to obtain the point estimates of the itraconazole effect and 90 percent (%) confidence intervals (CIs).||1.1792|0.9569|
72461533|NCT00141271|144445625|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3308||||||For all secondary efficacy analyses, no multiple comparison adjustment were made.|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint||||0.3308
72461534|NCT00141271|144445626|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3355||||||For all efficacy analyses, no multiple comparisons adjustments were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Week 3||||0.3355
72461535|NCT00141271|144445626|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8447||||||For all efficacy analyses, no multiple comparisons adjustments were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Week 3||||0.8447
72461536|NCT00141271|144445626|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8959||||||For all efficacy analyses, no multiple comparisons adjustments were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Week 6||||0.8959
72461537|NCT00141271|144445626|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4826||||||For all efficacy analyses, no multiple comparisons adjustments were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Week 6||||0.4826
72461538|NCT00141271|144445626|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4178||||||For all efficacy analyses, no multiple comparisons adjustments were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint||||0.4178
72461539|NCT00141271|144445626|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8277||||||For all efficacy analyses, no multiple comparisons adjustments were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint||||0.8277
72461540|NCT00141271|144445627|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7758||||||For all efficacy analyses, no multiple comparisons adjustments were made.|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Week 3||||0.7758
72461541|NCT00141271|144445627|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8737||||||For all efficacy analyses, no multiple comparisons adjustments were made.|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Week 3||||0.8737
72461542|NCT00141271|144445627|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1151||||||For all efficacy analyses, no multiple comparisons adjustments were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Week 6||||0.1151
72461543|NCT00141271|144445627|SUPERIORITY_OR_OTHER_LEGACY|||||||0.129||||||For all efficacy analyses, no multiple comparisons adjustments were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Week 6||||0.1290
72461544|NCT00141271|144445627|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4432||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint||||0.4432
72461545|NCT00141271|144445627|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2988||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint||||0.2988
72461546|NCT00141271|144445628|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8598||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Week 3||||0.8598
72461547|NCT00141271|144445628|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6513||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Week 3||||0.6513
72461548|NCT00141271|144445628|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6272||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Week 6||||0.6272
72461549|NCT00141271|144445628|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6467||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Week 6||||0.6467
72461550|NCT00141271|144445628|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8049||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint||||0.8049
72461551|NCT00141271|144445628|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9411||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate.||Endpoint||||0.9411
72461552|NCT00141271|144445629|SUPERIORITY_OR_OTHER_LEGACY|||||||0.926||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint||||0.9260
72461553|NCT00141271|144445629|SUPERIORITY_OR_OTHER_LEGACY|||||||0.71||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint||||0.7100
72461554|NCT00141271|144445630|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1836||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint||||0.1836
72461555|NCT00141271|144445630|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1374||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint||||0.1374
72461556|NCT00141271|144445631|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9237||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint||||0.9237
72461557|NCT00141271|144445631|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3786||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint||||0.3786
72461558|NCT00141271|144445632|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4624||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint||||0.4624
72461559|NCT00141271|144445632|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5971|||||||ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint||||0.5971
72461560|NCT00141271|144445633|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1378||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint||||0.1378
72461561|NCT00141271|144445633|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7665||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint||||0.7665
72461562|NCT00141271|144445634|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4767||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate.||Endpoint||||0.4767
72461563|NCT00141271|144445634|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2066||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate.||Endpoint||||0.2066
72501617|NCT01126580|144533183|SUPERIORITY_OR_OTHER||||||<|0.001||||||Treatment comparison of HOMA2-%B at 26 weeks.|Mixed Models Analysis|||||||<0.001
72501618|NCT01126580|144533183|SUPERIORITY_OR_OTHER||||||<|0.001||||||Treatment comparison of HOMA2-%B at 26 weeks.|Mixed Models Analysis|||||||<0.001
72501619|NCT01126580|144533183|SUPERIORITY_OR_OTHER||||||<|0.001||||||Treatment comparison of HOMA2-%B at 52 weeks.|Mixed Models Analysis|||||||<0.001
72501620|NCT01126580|144533183|SUPERIORITY_OR_OTHER|||||||0.003||||||Treatment comparison of HOMA2-%B at 52 weeks.|Mixed Models Analysis|||||||0.003
72501621|NCT01126580|144533183|SUPERIORITY_OR_OTHER|||||||0.001||||||Treatment comparison of HOMA2-%S at 26 weeks.|Mixed Models Analysis|||||||0.001
72501622|NCT01126580|144533183|SUPERIORITY_OR_OTHER|||||||0.01||||||Treatment comparison of HOMA2-%S at 26 weeks.|Mixed Models Analysis|||||||0.010
72501623|NCT01126580|144533183|SUPERIORITY_OR_OTHER|||||||0.077||||||Treatment comparison of HOMA2-%S at 52 weeks.|Mixed Models Analysis|||||||0.077
72461564|NCT00141271|144445635|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1667||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint||||0.1667
72461565|NCT00141271|144445635|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6727||||||For all secondary efficacy analyses, no multiple comparison adjustment were made.|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint||||0.6727
72461566|NCT00141271|144445636|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7019||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint||||0.7019
72461567|NCT00141271|144445636|SUPERIORITY_OR_OTHER_LEGACY|||||||0.102||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint||||0.1020
72461568|NCT00141271|144445637|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4749||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint||||0.4749
72461569|NCT00141271|144445637|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4491||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint||||0.4491
72461570|NCT00141271|144445638|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4398||||||For all efficacy analyses, no multiple comparisons adjustments were made.|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint||||0.4398
72501624|NCT01126580|144533183|SUPERIORITY_OR_OTHER|||||||0.004||||||Treatment comparison of HOMA2-%S at 52 weeks.|Mixed Models Analysis|||||||0.004
72501625|NCT00609622|144533212|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.705||||0.9963|TWO_SIDED|95.0|1.272|5.751|||Log Rank|||P-value was calculated from a 1-sided, log-rank test stratified for Eastern Cooperative Oncology Group (ECOG) Performance Status (0 vs. 1), Baseline Lactate Dehydrogenase (LDH): greater than (\>) 1.5 vs. less than or equal to (\<=) 1.5 \* upper limit of normal range (ULN), and Prior Adjuvant Treatment (yes vs. no).||5.751|1.272|0.9963
72563539|NCT03173170|144658315|OTHER||Mean ratio|1.4892|||||TWO_SIDED|90.0|1.3851|1.6012||||||A paired t-test on the natural log-transformed parameters was performed. The means and difference of means for the log-transformed parameters were exponentiated to obtain the point estimates of the itraconazole effect and 90% CIs.||1.6012|1.3851|
72563540|NCT01280617|144658316|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|Continuous variables analyzed using 2-tailed t test or Mann Whitney tes.. Categorical variables analyzed using Chi-Square or Fisher's Exact test||||||<0.05
72563541|NCT01280617|144658316|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
72563542|NCT04205162|144658321|OTHER|||||||0.331|||||||Wilcoxon (Mann-Whitney)|||Comparison of etafilcon A||||0.331
72563543|NCT04205162|144658321|OTHER|||||||0.122|||||||Wilcoxon (Mann-Whitney)|||Comparison of verofilcon A||||0.122
72563544|NCT04205162|144658322|OTHER|||||||0.13|||||||Wilcoxon (Mann-Whitney)|||Comparison of etafilcon A||||0.130
72563545|NCT04205162|144658322|OTHER|||||||0.924|||||||Wilcoxon (Mann-Whitney)|||Comparison of verofilcon A||||0.924
72563546|NCT03460158|144658324|OTHER||Mean Difference (Final Values)|0.023|STANDARD_ERROR_OF_MEAN|0.1524||0.8822|TWO_SIDED|95.0|||||t-test, 2 sided|||Two-sample t test with equal variances the null hypothesis is the relative change in volume and relative change in patient reported outcomes will be the same at 2 weeks post injection||||0.8822
72563547|NCT03460158|144658324|OTHER||Mean Difference (Final Values)|-0.18|STANDARD_ERROR_OF_MEAN|0.1466||0.2223|TWO_SIDED|95.0|||||t-test, 2 sided|||Two-sample t test with equal variances the null hypothesis is the change in volume and change in patient reported outcomes will be the same at 4 weeks post injection||||0.2223
72501626|NCT00609622|144533213|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.618||||0.9289|TWO_SIDED|95.0|0.845|3.096|||Log Rank|||P-value was calculated from a 1-sided, log-rank test stratified for ECOG Performance Status (0 vs. 1), Baseline LDH: \>1.5 vs. \<=1.5 \* ULN, and Prior Adjuvant Treatment (yes vs. no).||3.096|0.845|0.9289
72501627|NCT00609622|144533216|SUPERIORITY_OR_OTHER||F-Distribution|3.956||||0.5898|TWO_SIDED|95.0|-10.412|18.324|||Chi-squared|||||18.324|-10.412|0.5898
72461571|NCT00141271|144445638|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3331||||||For all efficacy analyses, no multiple comparisons adjustments were made.|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint||||0.3331
72461572|NCT00141271|144445639|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2763||||||For all efficacy analyses, no multiple comparisons adjustments were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint||||0.2763
72461573|NCT00141271|144445639|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2048||||||For all efficacy analyses, no multiple comparisons adjustments were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint||||0.2048
72461574|NCT00141271|144445640|SUPERIORITY_OR_OTHER_LEGACY|||||||0.434||||||For all efficacy analyses, no multiple comparisons adjustments were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint||||0.4340
72563548|NCT03460158|144658324|OTHER||Mean Difference (Final Values)|-0.369|STANDARD_ERROR_OF_MEAN|0.113||0.0015|TWO_SIDED|95.0|||||t-test, 2 sided|||Two-sample t test with equal variances the null hypothesis is the change in volume and change in patient reported outcomes will be the same at 12 weeks post injection||||0.0015
72563549|NCT01011556|144658326|NON_INFERIORITY_OR_EQUIVALENCE|A noninferiority margin of 3.5% was used.|Difference in Least Square Means|-7.17|||<|0.001|TWO_SIDED|90.0|-8.489|-5.851|||ANCOVA|Analyses were performed using ANCOVA model with the baseline value as a covariate and pooled site and treatment as fixed effects.||||-5.851|-8.489|<0.001
72563550|NCT01011556|144658326|NON_INFERIORITY_OR_EQUIVALENCE|A noninferiority margin of 3.5% was used.|Difference in Least Square Means|-7.48|||<|0.001|TWO_SIDED|90.0|-8.822|-6.144|||ANCOVA|Analyses were performed using ANCOVA model with the baseline value as a covariate and pooled site and treatment as fixed effects.||||-6.144|-8.822|<0.001
72461575|NCT00141271|144445640|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7774||||||For all efficacy analyses, no multiple comparisons adjustments were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate.||Endpoint||||0.7774
72461576|NCT00141271|144445641|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5195||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate.||Endpoint||||0.5195
72461577|NCT00141271|144445641|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0153||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate.||Endpoint||||0.0153
72461578|NCT00141271|144445642|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2847||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate.||Endpoint||||0.2847
72461579|NCT00141271|144445642|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1958||||||For all secondary efficacy analyses, no multiple comparison adjustment were made.|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint||||0.1958
72461580|NCT00141271|144445643|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1652||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint||||0.1652
72461581|NCT00141271|144445643|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5997||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint||||0.5997
72461582|NCT00141271|144445644|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0082||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint||||0.0082
72461583|NCT00141271|144445644|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7037||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint||||0.7037
72461584|NCT00141271|144445645|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2718||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint||||0.2718
72501628|NCT00609622|144533218|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.4||||0.0515|TWO_SIDED|95.0|-2.82|0.01|||t-test, 2 sided|||Differences in PWB between treatment arms (C4 of D1) was analyzed from a two-sample t-test.||0.01|-2.82|0.0515
72501629|NCT00609622|144533218|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.45||||0.0876|TWO_SIDED|95.0|-3.11|0.22|||t-test, 2 sided|||Differences in PWB between treatment arms (C7 of D1) was analyzed from a two-sample t-test.||0.22|-3.11|0.0876
72501630|NCT00609622|144533218|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.81||||0.0522|TWO_SIDED|95.0|-3.64|0.02|||t-test, 2 sided|||Differences in PWB between treatment arms (C10 of D1) was analyzed from a two-sample t-test.||0.02|-3.64|0.0522
72501631|NCT00609622|144533218|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.64||||0.1339|TWO_SIDED|95.0|-3.81|0.52|||t-test, 2 sided|||Differences in PWB between treatment arms (C13 of D1) was analyzed from a two-sample t-test.||0.52|-3.81|0.1339
72563551|NCT01011556|144658326|NON_INFERIORITY_OR_EQUIVALENCE|A noninferiority margin of 3.5% was used.|Difference in Least Square Means|-6.17|||<|0.001|TWO_SIDED|90.0|-7.448|-4.891|||ANCOVA|Analyses were performed using ANCOVA model with the baseline value as a covariate and pooled site and treatment as fixed effects.||||-4.891|-7.448|<0.001
72461585|NCT00141271|144445645|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7077||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint||||0.7077
72461586|NCT00141271|144445646|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5057||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint||||0.5057
72461587|NCT00141271|144445646|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3654||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint||||0.3654
72461588|NCT00141271|144445647|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6227||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint||||0.6227
72461589|NCT00141271|144445647|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7737||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint||||0.7737
72501632|NCT00609622|144533218|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.05||||0.4233|TWO_SIDED|95.0|-3.68|1.57|||t-test, 2 sided|||Differences in PWB between treatment arms (C16 of D1) was analyzed from a two-sample t-test.||1.57|-3.68|0.4233
72501633|NCT00609622|144533218|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.97||||0.2211|TWO_SIDED|95.0|-5.18|1.24|||t-test, 2 sided|||Differences in PWB between treatment arms (C19 of D1) was analyzed from a two-sample t-test.||1.24|-5.18|0.2211
72501634|NCT00609622|144533218|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.41||||0.8184|TWO_SIDED|95.0|-3.22|4.04|||t-test, 2 sided|||Differences in PWB between treatment arms (C22 of D1) was analyzed from a two-sample t-test.||4.04|-3.22|0.8184
72501635|NCT00609622|144533218|SUPERIORITY_OR_OTHER||Mean Difference (Net)|8.9||||0.038|TWO_SIDED|95.0|0.57|17.23|||t-test, 2 sided|||Differences in PWB between treatment arms (C25 of D1) was analyzed from a two-sample t-test.||17.23|0.57|0.0380
72501636|NCT00609622|144533218|SUPERIORITY_OR_OTHER||Mean Difference (Net)|5.6||||0.3266|TWO_SIDED|95.0|-6.61|17.81|||t-test, 2 sided|||Differences in PWB between treatment arms (C28 of D1) was analyzed from a two-sample t-test.||17.81|-6.61|0.3266
72621072|NCT02732145|144773172|EQUIVALENCE|Question: Is there a difference in the score for non-specific vulvar lesions in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||0.8987|||||||Wilcoxon (Mann-Whitney)|||Parameter: The difference in the score for non-specific vulvar lesions (median) in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology.||||0.8987
72461590|NCT04853394|144445682|SUPERIORITY||Risk Ratio (RR)|0.33|||<|0.01|TWO_SIDED|95.0|0.21|0.51|||Mixed Models Analysis|Mixed effects modified Poisson regression model with random intercepts for participant and network cluster|Effect of MASLIHAT vs. comparison TANSIHAT condition at 12-month follow-up|||.51|.21|<.01
72461591|NCT04853394|144445683|SUPERIORITY||Risk Ratio (RR)|0.67||||0.01|TWO_SIDED|95.0|0.46|0.97|||Mixed Models Analysis|Mixed effects modified Poisson regression model with random intercepts for participant and network cluster|Effect of MASLIHAT vs. comparison TANSIHAT condition at 12-month follow-up|||.97|.46|.01
72461592|NCT04853394|144445684|SUPERIORITY||Risk Ratio (RR)|0.86||||0.01|TWO_SIDED|95.0|0.77|0.95|||Mixed Models Analysis|Mixed effects Poisson regression model with random intercepts for participant and network cluster|Effect of MASLIHAT vs. comparison TANSIHAT condition at 6-month follow-up|||.95|.77|.01
72461593|NCT04853394|144445684|SUPERIORITY||Risk Ratio (RR)|1.19||||0.01|TWO_SIDED|95.0|0.98|1.45|||Mixed Models Analysis|Mixed effects Poisson regression model with random intercepts for participant and network cluster|Effect of MASLIHAT vs. comparison TANSIHAT condition at 12-month follow-up|||1.45|.98|.01
72461594|NCT04853394|144445687|SUPERIORITY||Risk Ratio (RR)|0.12||||0.01|TWO_SIDED|95.0|0.07|0.19|||Mixed Models Analysis|Mixed effects Poisson regression model with random intercepts for participant and network cluster|Effect of MASLIHAT vs. comparison TANSIHAT condition at 12-month follow-up|||.19|.07|.01
72461595|NCT02878590|144445726|SUPERIORITY|||||||0.0093|||||||t-test, 2 sided|||||||0.0093
72461596|NCT01178281|144445727|OTHER|||||||1|||||||Fisher Exact|||||||1.000
72461597|NCT01178281|144445729|OTHER|||||||0.929|||||||Log Rank|||||||0.929
72461598|NCT00331799|144445767|SUPERIORITY_OR_OTHER|||||||0.00365|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||Wilcoxon Signed Rank test on the difference between the baseline and endpoint score on the CD-RISC.||||0.00365
72461599|NCT03149887|144445768|SUPERIORITY|||||||0.66|||||||t-test, 2 sided|||||||0.66
72461600|NCT03149887|144445769|SUPERIORITY|||||||0.54|||||||t-test, 2 sided|||||||0.54
72461601|NCT03149887|144445770|SUPERIORITY|||||||0.07|||||||t-test, 2 sided|||||||0.07
72461602|NCT03149887|144445771|SUPERIORITY|||||||0.003|||||||t-test, 2 sided|||||||0.003
72461603|NCT03149887|144445772|SUPERIORITY|||||||0.53|||||||t-test, 2 sided|||||||0.53
72461604|NCT03149887|144445773|SUPERIORITY|||||||0.84|||||||t-test, 2 sided|||||||0.84
72461605|NCT03149887|144445774|SUPERIORITY|||||||0.76|||||||t-test, 2 sided|||||||0.76
72461606|NCT03149887|144445775|SUPERIORITY|||||||0.44|||||||t-test, 2 sided|||||||0.44
72461607|NCT01090076|144445776|SUPERIORITY_OR_OTHER|||||||0.023||95.0|||||t-test, 2 sided|||||||0.023
72461608|NCT01090076|144445777|SUPERIORITY_OR_OTHER|||||||0.877||95.0|||||t-test, 2 sided|||||||0.877
72461609|NCT01090076|144445778|SUPERIORITY_OR_OTHER|||||||0.44||95.0|||||t-test, 2 sided|||||||0.44
72461610|NCT00113880|144445785|SUPERIORITY_OR_OTHER|||||||0.01||||||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple confidence intervals (CIs) were constructed without multiplicity adjustment.|Exact method or Cox model|||Breast lump/cyst event rates were presented per 1,000 person-months. If the control group has no event, the relative risk (RR) or hazard ratio (HR) is not estimable.||||0.01
72461611|NCT00113880|144445785|SUPERIORITY_OR_OTHER|||||||0.01||||||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment|Exact method or Cox model|||Breast lump/cyst event rates were presented per 1,000 person-months. If the control group has no event, the RR or HR is not estimable.||||0.01
72461612|NCT00113880|144445785|SUPERIORITY_OR_OTHER|||||||0.02||||||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Exact method or Cox model|||Breast lump/cyst event rates were presented per 1,000 person-months. If the control group has no event, the RR or HR is not estimable.||||0.02
72461613|NCT00113880|144445785|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.59||||0.02|TWO_SIDED|95.0|0.64|3.92||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Regression, Cox|||Mastitis event rates were presented per 1,000 person-months.||3.92|0.64|0.02
72461614|NCT00113880|144445785|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|7.35||||0.01|TWO_SIDED|95.0|2.2|24.54||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Regression, Cox|||Mastitis event rates were presented per 1,000 person-months.||24.54|2.20|0.01
72461615|NCT00113880|144445785|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|7.17||||0.01|TWO_SIDED|95.0|2.13|24.13||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Regression, Cox|||Mastitis event rates were presented per 1,000 person-months.||24.13|2.13|0.01
72461616|NCT00113880|144445786|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.05||||0.03|TWO_SIDED|95.0|0.0|0.79||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Regression, Cox|||Heart murmur event rates were presented per 1,000 person-months.||0.79|0.00|0.03
72501637|NCT00609622|144533218|SUPERIORITY_OR_OTHER||Mean Difference (Net)|5.75||||0.4667|TWO_SIDED|95.0|-16.26|27.76|||t-test, 2 sided|||Differences in PWB between treatment arms (C31 of D1) was analyzed from a two-sample t-test.||27.76|-16.26|0.4667
72501638|NCT00609622|144533218|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0|||<|0.0001|TWO_SIDED|95.0|0.0|0.0|||t-test, 2 sided|||Differences in PWB between treatment arms (C34 of D1) was analyzed from a two-sample t-test.||0|0|<0.0001
72501639|NCT00609622|144533218|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.64||||0.5587|TWO_SIDED|95.0|-2.8|1.52|||t-test, 2 sided|||Differences in PWB between treatment arms (EOT) was analyzed from a two-sample t-test.||1.52|-2.80|0.5587
72501640|NCT00609622|144533218|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.28||||0.6122|TWO_SIDED|95.0|-1.37|0.81|||t-test, 2 sided|||Differences in SWB between treatment arms (C4 of D1) was analyzed from a two-sample t-test.||0.81|-1.37|0.6122
72461617|NCT00113880|144445786|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.13||||0.05|TWO_SIDED|95.0|0.02|1.0||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment|Regression, Cox|||Heart murmur event rates were presented per 1,000 person-months.||1.00|0.02|0.05
72461618|NCT00113880|144445786|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.11||||0.04|TWO_SIDED|95.0|0.01|0.86||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Regression, Cox|||Heart murmur event rates were presented per 1,000 person-months.||0.86|0.01|0.04
72461619|NCT00113880|144445786|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.37||||0.01|TWO_SIDED|95.0|0.2|0.7||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Regression, Cox||Population was the 18-49 year age group.|Pregnancy exam/supervision event rates were presented per 1,000 person-months.||0.70|0.20|0.01
72461620|NCT00113880|144445786|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.4||||0.01|TWO_SIDED|95.0|0.22|0.74||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Regression, Cox||Population was the all ages combined group.|Pregnancy exam/supervision event rates were presented per 1,000 person-months.||0.74|0.22|0.01
72563552|NCT01011556|144658327|SUPERIORITY_OR_OTHER||Difference in Least Square Means|-4.58|||<|0.001|TWO_SIDED|90.0|-5.716|-3.452|||ANCOVA|Analyses were performed using ANCOVA model with the baseline value as a covariate and pooled site and treatment as fixed effects.||||-3.452|-5.716|<0.001
72563553|NCT01011556|144658327|SUPERIORITY_OR_OTHER||Difference in Least Square Means|-3.87|||<|0.001|TWO_SIDED|90.0|-5.006|-2.727|||ANCOVA|Analyses were performed using ANCOVA model with the baseline value as a covariate and pooled site and treatment as fixed effects.||||-2.727|-5.006|<0.001
72563554|NCT01011556|144658327|SUPERIORITY_OR_OTHER||Difference in Least Square Means|-3.56|||<|0.001|TWO_SIDED|90.0|-4.652|-2.464|||ANCOVA|Analyses were performed using ANCOVA model with the baseline value as a covariate and pooled site and treatment as fixed effects.||||-2.464|-4.652|<0.001
72563555|NCT01011556|144658328|SUPERIORITY_OR_OTHER||Difference in Least Square Means|-4.53|STANDARD_ERROR_OF_MEAN|0.687|<|0.001|TWO_SIDED|90.0|-5.663|-3.392||p-value is for change in BMD at 6 months|Mixed Models Analysis|MMRM Model: Percentage change in BMD = treatment+baseline+pooled site+visit+treatment\*visit interaction. Repeat measure occurred at each visit.||||-3.392|-5.663|<0.001
72563556|NCT01011556|144658328|SUPERIORITY_OR_OTHER||Difference in Least Square Means|-3.94|STANDARD_ERROR_OF_MEAN|0.692|<|0.001|TWO_SIDED|90.0|-5.086|-2.8||p-value is for change in BMD at 6 months|Mixed Models Analysis|MMRM Model: Percentage change in BMD = treatment+baseline+pooled site+visit+treatment\*visit interaction. Repeat measure occurred at each visit.||||-2.800|-5.086|<0.001
72563557|NCT01011556|144658328|SUPERIORITY_OR_OTHER||Difference in Least Square Means|-3.53|STANDARD_ERROR_OF_MEAN|0.665|<|0.001|TWO_SIDED|90.0|-4.627|-2.43||p-value is for change in BMD at 6 months|Mixed Models Analysis|MMRM Model: Percentage change in BMD = treatment+baseline+pooled site+visit+treatment\*visit interaction. Repeat measure occurred at each visit.||||-2.430|-4.627|<0.001
72563558|NCT01011556|144658328|SUPERIORITY_OR_OTHER||Difference in Least Square Means|-7.5|STANDARD_ERROR_OF_MEAN|0.818|<|0.001|TWO_SIDED|90.0|-8.856|-6.151||p-value is for change in BMD at 12 months|Mixed Models Analysis|MMRM Model: Percentage change in BMD = treatment+baseline+pooled site+visit+treatment\*visit interaction. Repeat measure occurred at each visit.||||-6.151|-8.856|<0.001
72563559|NCT01011556|144658328|SUPERIORITY_OR_OTHER||Difference in Least Square Means|-7.46|STANDARD_ERROR_OF_MEAN|0.83||0.001|TWO_SIDED|90.0|-8.835|-6.091||p-value for change in BMD at 12 months|Mixed Models Analysis|MMRM Model: Percentage change in BMD = treatment+baseline+pooled site+visit+treatment\*visit interaction. Repeat measure occurred at each visit.||||-6.091|-8.835|0.001
72563560|NCT01011556|144658328|SUPERIORITY_OR_OTHER||Difference in Least Square Means|-6.19|STANDARD_ERROR_OF_MEAN|0.802||0.001|TWO_SIDED|90.0|-7.51|-4.86||p-value is for change in BMD at 12 months|Mixed Models Analysis|MMRM Model: Percentage change in BMD = treatment+baseline+pooled site+visit+treatment\*visit interaction. Repeat measure occurred at each visit.||||-4.860|-7.510|0.001
72563561|NCT01011556|144658329|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon Rank Sum Test|Pairwise comparison p-value at 1 month.||||||<0.001
72563562|NCT01011556|144658329|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon Rank Sum Test|Pairwise comparison p-value at 1 month.||||||<0.001
72563563|NCT01011556|144658329|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon Rank Sum Test|Pairwise comparison p-value at 1 month.||||||<0.001
72563564|NCT01011556|144658329|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon Rank Sum Test|Pairwise comparison p-value at 3 months.||||||<0.001
72563565|NCT01011556|144658329|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon Rank Sum Test|Pairwise comparison p-value at 3 months.||||||<0.001
72563566|NCT01011556|144658329|SUPERIORITY_OR_OTHER|||||||0.003||95.0|||||Wilcoxon Rank Sum Test|Pairwise comparison p-value at 3 months.||||||0.003
72563567|NCT01011556|144658329|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon Rank Sum Test|Pairwise comparison p-value at 6 months.||||||<0.001
72563568|NCT01011556|144658329|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon Rank Sum Test|Pairwise comparison p-value at 6 months.||||||<0.001
72563569|NCT01011556|144658329|SUPERIORITY_OR_OTHER|||||||0.029||95.0|||||Wilcoxon Rank Sum Test|Pairwise comparison p-value at 6 months.||||||0.029
72563570|NCT01011556|144658329|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon Rank Sum Test|Pairwise comparison p-value at 12 months.||||||<0.001
72563571|NCT01011556|144658329|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon Rank Sum Test|Pairwise comparison p-value at 12 months.||||||<0.001
72563572|NCT01011556|144658329|SUPERIORITY_OR_OTHER|||||||0.047||95.0|||||Wilcoxon Rank Sum Test|Pairwise comparison p-value at 12 months.||||||0.047
72563573|NCT01011556|144658330|SUPERIORITY_OR_OTHER|||||||0.822||95.0|||||Wilcoxon Rank Sum Test|Pairwise comparison p-value at 1 month.||||||0.822
72563574|NCT01011556|144658330|SUPERIORITY_OR_OTHER|||||||0.406||95.0|||||Wilcoxon Rank Sum Test|Pairwise comparison p-value at 1 month.||||||0.406
72461621|NCT00113880|144445786|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.05||||0.01|TWO_SIDED|95.0|0.03|0.08||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Regression, Cox||Population was the 18-49 year age and the all ages combined groups.|Pregnancy exam/supervision event rates were presented per 1,000 person-months.||0.08|0.03|0.01
72461622|NCT00113880|144445786|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.02||||0.01|TWO_SIDED|95.0|0.01|0.03|||Regression, Cox||Population was the 18-49 year age and all ages combined groups.|Pregnancy exam/supervision event rates were presented per 1,000 person-months.||0.03|0.01|0.01
72461623|NCT00113880|144445787|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.06||||0.04|TWO_SIDED|95.0|1.02|4.13||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Regression, Cox|||Urticaria event rates were presented per 1,000 person-months.||4.13|1.02|0.04
72461624|NCT00113880|144445789|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.71||||0.01|TWO_SIDED|95.0|0.56|0.89||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Fisher Exact||Population: all ages combined within 21 days. The rate of events during the risk period represents the numerator; the rate of events during the control period represents the denominator.|Any asthma or wheezing event rates were presented per 1,000 person-months.||0.89|0.56|0.01
72461625|NCT00113880|144445789|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.59||||0.01|TWO_SIDED|95.0|0.41|0.83||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Fisher Exact||Population: 5-8 years within 21 days. The rate of events during the risk period represents the numerator; the rate of events during the control period represents the denominator.|Any asthma or wheezing event rates were presented per 1,000 person-months.||0.83|0.41|0.01
72461626|NCT00113880|144445789|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.68||||0.04|TWO_SIDED|95.0|0.46|0.99||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Fisher Exact||Population: 18-49 years within 42 days. The rate of events in FluMist recipients represents the numerator; the rate of events in unvaccinated controls represents the denominator.|Any asthma or wheezing event rates were presented per 1,000 person-months.||0.99|0.46|0.04
72461627|NCT00113880|144445790|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.33||||0.01|TWO_SIDED|95.0|0.27|0.41||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Fisher Exact||Population: all ages combined within 21 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Any asthma or wheezing event rates were presented per 1,000 person-months.||0.41|0.27|0.01
72461628|NCT00113880|144445790|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.3||||0.01|TWO_SIDED|95.0|0.22|0.42||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Fisher Exact||Population: 5-8 years within 21 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Any asthma or wheezing event rates were presented per 1,000 person-months||0.42|0.22|0.01
72461629|NCT00113880|144445790|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.34||||0.01|TWO_SIDED|95.0|0.24|0.47||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Fisher Exact||Population: 9-17 years within 21 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Any asthma or wheezing event rates were presented per 1,000 person-months.||0.47|0.24|0.01
72461630|NCT00113880|144445790|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.42||||0.01|TWO_SIDED|95.0|0.23|0.75||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Fisher Exact||Population: 18-49 years within 21 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Any asthma or wheezing event rates were presented per 1,000 person-months.||0.75|0.23|0.01
72461631|NCT00113880|144445790|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.38||||0.01|TWO_SIDED|95.0|0.33|0.44||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Fisher Exact||Population: all ages combined within 42 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Any asthma or wheezing event rates were presented per 1,000 person-months.||0.44|0.33|0.01
72501641|NCT00609622|144533218|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.51||||0.4642|TWO_SIDED|95.0|-1.87|0.86|||t-test, 2 sided|||Differences in SWB between treatment arms (C7 of D1) was analyzed from a two-sample t-test.||0.86|-1.87|0.4642
72501642|NCT00609622|144533218|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.94||||0.2105|TWO_SIDED|95.0|-2.41|0.54|||t-test, 2 sided|||Differences in SWB between treatment arms (C10 of D1) was analyzed from a two-sample t-test.||0.54|-2.41|0.2105
72501643|NCT00609622|144533218|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.09||||0.195|TWO_SIDED|95.0|-0.57|2.76|||t-test, 2 sided|||Differences in SWB between treatment arms (C13 of D1) was analyzed from a two-sample t-test.||2.76|-0.57|0.1950
72501644|NCT00609622|144533218|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.6||||0.5779|TWO_SIDED|95.0|-1.55|2.75|||t-test, 2 sided|||Differences in SWB between treatment arms (C16 of D1) was analyzed from a two-sample t-test.||2.75|-1.55|0.5779
72501645|NCT00609622|144533218|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.67||||0.6314|TWO_SIDED|95.0|-2.15|3.5|||t-test, 2 sided|||Differences in SWB between treatment arms (C19 of D1) was analyzed from a two-sample t-test.||3.50|-2.15|0.6314
72501646|NCT00609622|144533218|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.51||||0.7554|TWO_SIDED|95.0|-2.85|3.87|||t-test, 2 sided|||Differences in SWB between treatment arms (C22 of D1) was analyzed from a two-sample t-test.||3.87|-2.85|0.7554
72501647|NCT00609622|144533218|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.94||||0.3781|TWO_SIDED|95.0|-13.22|5.34|||t-test, 2 sided|||Differences in SWB between treatment arms (C25 of D1) was analyzed from a two-sample t-test.||5.34|-13.22|0.3781
72501648|NCT00609622|144533218|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.85||||0.5715|TWO_SIDED|95.0|-13.83|8.13|||t-test, 2 sided|||Differences in SWB between treatment arms (C28 of D1) was analyzed from a two-sample t-test.||8.13|-13.83|0.5715
72461632|NCT00113880|144445790|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.4||||0.01|TWO_SIDED|95.0|0.32|0.5||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Fisher Exact||Population: 5-8 years within 42 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Any asthma or wheezing event rates were presented per 1,000 person-months.||0.50|0.32|0.01
72461633|NCT00113880|144445790|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.36||||0.01|TWO_SIDED|95.0|0.28|0.45||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Fisher Exact||Population: 9-17 years within 42 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Any asthma or wheezing event rates were presented per 1,000 person-months.||0.45|0.28|0.01
72461634|NCT00113880|144445790|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.41||||0.01|TWO_SIDED|95.0|0.27|0.6||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Fisher Exact||Population: 18-49 years within 42 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Any asthma or wheezing event rates were presented per 1,000 person-months.||0.60|0.27|0.01
72461635|NCT00113880|144445790|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.47||||0.05|TWO_SIDED|95.0|0.21|0.99||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Fisher Exact||Population: 5-8 years, PD2 within 42 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Any asthma or wheezing event rates were presented per 1,000 person-months.||0.99|0.21|0.05
72461636|NCT00113880|144445791|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.92||||0.01|TWO_SIDED|95.0|0.86|0.98||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Fisher Exact||Population: all ages combined, within 180 days, PD1. The rate of events in FluMist recipients represents the numerator; the rate of events in the unvaccinated controls represents the denominator.|Any asthma or wheezing event rates were presented per 1,000 person-months.||0.98|0.86|0.01
72461637|NCT00113880|144445791|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.83||||0.01|TWO_SIDED|95.0|0.75|0.92||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Fisher Exact||Population: 9-17 yrs., within 180 days, PD1. The rate of events in FluMist recipients represents the numerator; the rate of events in the unvaccinated controls represents the denominator.|Any asthma or wheezing event rates were presented per 1,000 person-months||0.92|0.75|0.01
72461638|NCT00113880|144445791|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.87||||0.01|TWO_SIDED|95.0|0.81|0.94||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Fisher Exact||Population: All ages, within 180 days, PD1. The rate of events in FluMist recipients represents the numerator; the rate of events in the unvaccinated controls represents the denominator.|Asthma/RAD event rates were presented per 1,000 person-months.||0.94|0.81|0.01
72461639|NCT00113880|144445791|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.79||||0.01|TWO_SIDED|95.0|0.7|0.88||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Fisher Exact||Population: 9-17 yrs, within 180 days, PD1. The rate of events in FluMist recipients represents the numerator; the rate of events in the unvaccinated controls represents the denominator.|Asthma/RAD event rates were presented per 1,000 person-months.||0.88|0.70|0.01
72461640|NCT00113880|144445791|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.49||||0.01|TWO_SIDED|95.0|0.29|0.79||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Fisher Exact||Population: 5-8yrs, within 180 days, PD2. The rate of events in FluMist recipients represents the numerator; the rate of events in the unvaccinated controls represents the denominator.|Asthma/RAD event rates were presented per 1,000 person-months.||0.79|0.29|0.01
72501649|NCT00609622|144533218|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-7.58||||0.1271|TWO_SIDED|95.0|-19.08|3.93|||t-test, 2 sided|||Differences in SWB between treatment arms (C31 of D1) was analyzed from a two-sample t-test.||3.93|-19.08|0.1271
72501650|NCT00609622|144533218|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0|||<|0.0001|TWO_SIDED|95.0|0.0|0.0|||t-test, 2 sided|||Differences in SWB between treatment arms (C34 of D1) was analyzed from a two-sample t-test.||0|0|<0.0001
72563575|NCT01011556|144658330|SUPERIORITY_OR_OTHER|||||||0.312||95.0|||||Wilcoxon Rank Sum Test|Pairwise comparison p-value at 1 month.||||||0.312
72501651|NCT00609622|144533218|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.27||||0.6785|TWO_SIDED|95.0|-1.03|1.58|||t-test, 2 sided|||Differences in SWB between treatment arms (EOT) was analyzed from a two-sample t-test.||1.58|-1.03|0.6785
72501652|NCT00609622|144533218|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.44||||0.4623|TWO_SIDED|95.0|-1.63|0.74|||t-test, 2 sided|||Differences in EWB between treatment arms (C4 of D1) was analyzed from a two-sample t-test.||0.74|-1.63|0.4623
72501653|NCT00609622|144533218|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.06||||0.9302|TWO_SIDED|95.0|-1.31|1.2|||t-test, 2 sided|||Differences in EWB between treatment arms (C7 of D1) was analyzed from a two-sample t-test.||1.20|-1.31|0.9302
72501654|NCT00609622|144533218|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.25||||0.7502|TWO_SIDED|95.0|-1.84|1.33|||t-test, 2 sided|||Differences in EWB between treatment arms (C10 of D1) was analyzed from a two-sample t-test.||1.33|-1.84|0.7502
72501655|NCT00609622|144533218|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.09||||0.9335|TWO_SIDED|95.0|-2.12|1.95|||t-test, 2 sided|||Differences in EWB between treatment arms (C13 of D1) was analyzed from a two-sample t-test.||1.95|-2.12|0.9335
72501656|NCT00609622|144533218|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.12||||0.9191|TWO_SIDED|95.0|-2.4|2.17|||t-test, 2 sided|||Differences in EWB between treatment arms (C16 of D1) was analyzed from a two-sample t-test.||2.17|-2.40|0.9191
72501657|NCT00609622|144533218|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.6||||0.675|TWO_SIDED|95.0|-3.46|2.27|||t-test, 2 sided|||Differences in EWB between treatment arms (C19 of D1) was analyzed from a two-sample t-test.||2.27|-3.46|0.6750
72563576|NCT01011556|144658330|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon Rank Sum Test|Pairwise comparison p-value at 3 months.||||||<0.001
72621073|NCT02732145|144773172|EQUIVALENCE|Question: Is there a difference in the score for specific vulvar lesions in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology (first biopsy)?||||||0.0018|||||||Wilcoxon (Mann-Whitney)|||Parameter: The difference in the score for vulvar lesions specific for dermatosis (median) in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology (first biopsy).||||0.0018
72621074|NCT02732145|144773172|EQUIVALENCE|"Question: Is there a difference in the overall sum of points for the Vulvoscopy Index in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology?"||||||0.4409|||||||Wilcoxon (Mann-Whitney)|||"Parameter: The difference in the overall sum of points for the Vulvoscopy Index (median) in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology."||||0.4409
72621075|NCT02732145|144773173|OTHER|"Question: Determination of sensitivity of the N-S-P Scheme as a measure of the sensitivity of Three Rings Vulvoscopy, in comparison to the histopathological diagnosis of vulvar dermatosis."|Sensitivity (2x2 Table)|1.0|||||TWO_SIDED|95.0|1.0|1.0|||||"The Sensitivity of the N-S-P Scheme for Detection of Vulvar Dermatosis was 1.0000 (Range: 1.0000 - 1.0000)."|"Parameter: Sensitivity of Three Rings Vulvoscopy for detection of vulvar dermatosis."||1.0000|1.0000|
72461641|NCT00113880|144445792|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.48||||0.01|TWO_SIDED|95.0|0.45|0.51||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Fisher Exact||Population: all ages combined, within 180 days, PD1. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Any asthma or wheezing event rates were presented per 1,000 person-months.||0.51|0.45|0.01
72461642|NCT00113880|144445792|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.51||||0.01|TWO_SIDED|95.0|0.47|0.56||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Fisher Exact||Population: 5-8 yrs, within 180 days, PD1. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Any asthma or wheezing event rates were presented per 1,000 person-months||0.56|0.47|0.01
72461643|NCT00113880|144445792|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.42||||0.01|TWO_SIDED|95.0|0.38|0.46||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Fisher Exact||Population: 9-17 yrs, within 180 days, PD1. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Any asthma or wheezing event rates were presented per 1,000 person-months.||0.46|0.38|0.01
72461644|NCT00113880|144445792|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.57||||0.01|TWO_SIDED|95.0|0.49|0.67||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Fisher Exact||Population: 18-49yrs, within 180 days, PD1. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Any asthma or wheezing event rates were presented per 1,000 person-months.||0.67|0.49|0.01
72461645|NCT00113880|144445792|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.51||||0.01|TWO_SIDED|95.0|0.33|0.76||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Fisher Exact||Population: 5-8 yrs, within 180 days, PD2. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Any asthma or wheezing event rates were presented per 1,000 person-months.||0.76|0.33|0.01
72461646|NCT00113880|144445792|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.42||||0.01|TWO_SIDED|95.0|0.39|0.45||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Fisher Exact||Population: all ages, within 180 days, PD1. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Asthma/RAD event rates event rates were presented per 1,000 person-months.||0.45|0.39|0.01
72461647|NCT00113880|144445792|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.42||||0.01|TWO_SIDED|95.0|0.38|0.47||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Fisher Exact||Population: 5-8 yrs, within 180 days, PD1. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Asthma/RAD event rates were presented per 1,000 person-months.||0.47|0.38|0.01
72501658|NCT00609622|144533218|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.88||||0.5874|TWO_SIDED|95.0|-4.2|2.43|||t-test, 2 sided|||Differences in EWB between treatment arms (C22 of D1) was analyzed from a two-sample t-test.||2.43|-4.20|0.5874
72501659|NCT00609622|144533218|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.27||||0.4507|TWO_SIDED|95.0|-7.53|16.06|||t-test, 2 sided|||Differences in EWB between treatment arms (C25 of D1) was analyzed from a two-sample t-test.||16.06|-7.53|0.4507
72501660|NCT00609622|144533218|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.9||||0.3087|TWO_SIDED|95.0|-4.28|12.08|||t-test, 2 sided|||Differences in EWB between treatment arms (C28 of D1) was analyzed from a two-sample t-test.||12.08|-4.28|0.3087
72621076|NCT02732145|144773173|OTHER|"Question: Determination of specificity of the N-S-P Scheme as a measure of the specificity of Three Rings Vulvoscopy, in comparison to the histopathological diagnosis of vulvar dermatosis."|Specificity (2x2 Table)|0.9609|||||TWO_SIDED|95.0|0.5794|1.0|||||"The Specificity of the N-S-P Scheme for Detection of Vulvar Dermatosis was 0.9609 (Range: 0.5794 - 1.0000)."|"Parameter: Specificity of Three Rings Vulvoscopy for detection of vulvar dermatosis."||1.0000|0.5794|
72621077|NCT02732145|144773173|OTHER|"Question: Determination of diagnostic accuracy of the N-S-P Scheme as a measure of the diagnostic value of the Three Rings Vulvoscopy, in relation to the histopathological diagnosis of vulvar dermatosis."|Diagnostic Accuracy (2x2 Table)|0.9695|||||TWO_SIDED|95.0|0.6313|1.0|||||"The Diagnostic accuracy of the N-S-P Scheme for Detection of Vulvar Dermatosis was 0.9695 (Range: 0.6313 - 1.0000)."|"Parameter: Diagnostic accuracy of Three Rings Vulvoscopy for detection of vulvar dermatosis."||1.0000|0.6313|
72392878|NCT02557646|144293337|SUPERIORITY_OR_OTHER|||||||0.5885|TWO_SIDED||||||Chi-squared|||The relationship between the starting dose of ribavirin and relapse rate was analyzed using Chi-square test.||||0.5885
72392879|NCT02557646|144293338|SUPERIORITY_OR_OTHER|||||||0.0062|TWO_SIDED||||||Chi-squared|||The relationship between the body weight-normalized dose of ribavirin and relapse rate was analyzed using Chi-square test.||||0.0062
72392880|NCT00518986|144293340|SUPERIORITY_OR_OTHER|||||||0.3043||95.0|||||ANCOVA|Study drug was fixed factor and corresponding baseline value was a covariate.||Since there were two primary outcome measures the Hochberg procedure was used to control overall Type 1 error rate at the 0.05 level. If both p-values for the primary variables were \<= 0.05 the treatment was claimed to be significant for both variables. If 1 p-value was \> 0.05and the other was \<=0.025, the variable with a p-value \<= 0.025 was claimed as significant.||||0.3043
72392881|NCT00518986|144293341|SUPERIORITY_OR_OTHER|||||||0.012|||||||Chi-squared|P-value for comparison is from a Pearson's chi-square test||Since there were two primary outcome measures the Hochberg procedure was used to control overall Type 1 error rate at the 0.05 level. If both p-values for the primary variables were \<= 0.05 the treatment was claimed to be significant for both variables. If 1 p-value was \> 0.05and the other was \<=0.025, the variable with a p-value \<= 0.025 was claimed as significant.||||0.0120
72392882|NCT00518986|144293342|SUPERIORITY_OR_OTHER|||||||0.0027||||||Nominal p-value is presented, but statistical significance cannot be claimed. As a key secondary variable significance could be claimed only if treatment effect was significant for both primary efficacy variables.|ANCOVA|||Least squares (LS) mean and standard error of the LS mean for each treatment group, and p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline as covariate.||||0.0027
72392883|NCT00518986|144293343|SUPERIORITY_OR_OTHER|||||||0.0019|||||||ANCOVA|||||||0.0019
72392884|NCT00518986|144293344|SUPERIORITY_OR_OTHER|||||||0.3145|||||||ANCOVA|||||||0.3145
72392885|NCT00518986|144293345|SUPERIORITY_OR_OTHER|||||||0.2196|||||||ANCOVA|||||||0.2196
72392886|NCT00518986|144293346|SUPERIORITY_OR_OTHER|||||||0.2017||||||P-value is from Pearson's chi-square test|Chi-squared|||||||0.2017
72392887|NCT00518986|144293347|SUPERIORITY_OR_OTHER|||||||0.0032||||||P-value from Pearson's chi-square test|Chi-squared|||||||0.0032
72392888|NCT00518986|144293348|SUPERIORITY_OR_OTHER|||||||0.0207||||||P-value from Pearson's chi-square test|Chi-squared|||||||0.0207
72392889|NCT00518986|144293349|SUPERIORITY_OR_OTHER|||||||0.0529||||||P-value was generated from a Cochran-Mantel-Haenszel chi-square test.|Cochran-Mantel-Haenszel|||||||0.0529
72392890|NCT00518986|144293350|SUPERIORITY_OR_OTHER|||||||0.0011|||||||Cochran-Mantel-Haenszel|||||||0.0011
72563577|NCT01011556|144658330|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon Rank Sum Test|Pairwise comparison p-value at 3 months.||||||<0.001
72392891|NCT00518986|144293351|SUPERIORITY_OR_OTHER|||||||0.0064||95.0|||||Cochran-Mantel-Haenszel|||||||0.0064
72392892|NCT00518986|144293352|SUPERIORITY_OR_OTHER|||||||0.1072|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.1072
72563578|NCT01011556|144658330|SUPERIORITY_OR_OTHER|||||||0.952||95.0|||||Wilcoxon Rank Sum Test|Pairwise comparison p-value at 3 months.||||||0.952
72563579|NCT01011556|144658330|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon Rank Sum Test|Pairwise comparison p-value at 6 months.||||||<0.001
72563580|NCT01011556|144658330|SUPERIORITY_OR_OTHER|||||||0.011||95.0|||||Wilcoxon Rank Sum Test|Pairwise comparison p-value at 6 months.||||||0.011
72392893|NCT00518986|144293353|SUPERIORITY_OR_OTHER|||||||0.0355|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0355
72392894|NCT00518986|144293354|SUPERIORITY_OR_OTHER|||||||0.0591|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0591
72392895|NCT00518986|144293355|SUPERIORITY_OR_OTHER|||||||0.0025|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0025
72392896|NCT00518986|144293356|SUPERIORITY_OR_OTHER|||||||0.0794||||||P-value for treatment comparison is from Pearson's chi-square test|Chi-squared|||||||0.0794
72392897|NCT00518986|144293357|SUPERIORITY_OR_OTHER|||||||0.0888||||||P-value for the treatment comparison is from a Pearson's chi-square test|Chi-squared|||||||0.0888
72392898|NCT00518986|144293358|SUPERIORITY_OR_OTHER|||||||0.0433||||||P-value for the treatment comparison is from a Pearson's chi-square test.|Chi-squared|||||||0.0433
72392899|NCT00518986|144293359|SUPERIORITY_OR_OTHER|||||||0.0105||||||P-value for the treatment comparison is from a Pearson's chi-square test.|Chi-squared|||||||0.0105
72392900|NCT00518986|144293360|SUPERIORITY_OR_OTHER|||||||0.0523|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0523
72392901|NCT00518986|144293361|SUPERIORITY_OR_OTHER|||||||0.0289|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0289
72392902|NCT00518986|144293362|SUPERIORITY_OR_OTHER|||||||0.1272|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.1272
72563581|NCT01011556|144658330|SUPERIORITY_OR_OTHER|||||||0.997||95.0|||||Wilcoxon Rank Sum Test|Pairwise comparison p-value at 6 months.||||||0.997
72563582|NCT01011556|144658330|SUPERIORITY_OR_OTHER|||||||0.003||95.0|||||Wilcoxon Rank Sum Test|Pairwise comparison p-value at 12 months.||||||0.003
72563583|NCT01011556|144658330|SUPERIORITY_OR_OTHER|||||||0.112||95.0|||||Wilcoxon Rank Sum Test|Pairwise comparison p-value at 12 months.||||||0.112
72563584|NCT01011556|144658330|SUPERIORITY_OR_OTHER|||||||0.988||95.0|||||Wilcoxon Rank Sum Test|Pairwise comparison p-value at 12 months.||||||0.988
72563585|NCT01011556|144658331|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon Rank Sum Test|Pairwise comparison p-value at 1 month.||||||<0.001
72392903|NCT00518986|144293363|SUPERIORITY_OR_OTHER|||||||0.0349|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0349
72392904|NCT00518986|144293364|SUPERIORITY_OR_OTHER|||||||0.0094|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0094
72392905|NCT00518986|144293365|SUPERIORITY_OR_OTHER|||||||0.0754|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0754
72461648|NCT00113880|144445792|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.37||||0.01|TWO_SIDED|95.0|0.34|0.41||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Fisher Exact||Population: 9-17 yrs, within 180 days, PD1. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Asthma/RAD event rates were presented per 1,000 person-months.||0.41|0.34|0.01
72461649|NCT00113880|144445792|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.58||||0.05|TWO_SIDED|95.0|0.49|0.68||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Fisher Exact||Population: 18-49 yrs, within 180 days, PD1. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Asthma/RAD event rates were presented per 1,000 person-months.||0.68|0.49|0.05
72563586|NCT01011556|144658331|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon Rank Sum Test|Pairwise comparison p-value at 1 month.||||||<0.001
72563587|NCT01011556|144658331|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon Rank Sum Test|Pairwise comparison p-value at 1 month.||||||<0.001
72563588|NCT01098110|144658349|SUPERIORITY_OR_OTHER_LEGACY||Least square (LS) means difference|-11.29|STANDARD_ERROR_OF_MEAN|2.1|<|0.0001|TWO_SIDED|95.0|-15.42|-7.16||Statistical significant: p=\<0.05, two sided|ANCOVA|Change from baseline a response variable, baseline score a covariate, treatment groups and regions as explanatory variables.|Asenapine 5 mg BID minus Placebo BID|||-7.16|-15.42|<0.0001
72563589|NCT01098110|144658349|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-13.22|STANDARD_ERROR_OF_MEAN|2.09|<|0.0001|TWO_SIDED|95.0|-17.33|-9.12||Statistical significant: p=\<0.05, two sided|ANCOVA|Change from baseline a response variable, baseline score a covariate, treatment groups and regions as explanatory variables.|Asenapine 10 mg BID minus Placebo BID|||-9.12|-17.33|<0.0001
72563590|NCT01098110|144658350|SUPERIORITY_OR_OTHER_LEGACY||Least square (LS) means difference|-3.47|STANDARD_ERROR_OF_MEAN|0.68|<|0.0001|TWO_SIDED|95.0|-4.8|-2.13|||ANCOVA|Change from baseline a response variable, baseline score a covariate.|Asenapine 5 mg BID minus Placebo BID|||-2.13|-4.80|<0.0001
72563591|NCT01098110|144658350|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-3.79|STANDARD_ERROR_OF_MEAN|0.67|<|0.0001|TWO_SIDED|95.0|-5.11|-2.46|||ANCOVA|Change from baseline a response variable, baseline score a covariate.|Asenapine 10 mg BID minus Placebo BID|||-2.46|-5.11|<0.0001
72563592|NCT01098110|144658351|SUPERIORITY_OR_OTHER_LEGACY||Least square (LS) means difference|-2.47|STANDARD_ERROR_OF_MEAN|0.54|<|0.0001|TWO_SIDED|95.0|-3.53|-1.41|||ANCOVA|Change from baseline a response variable, baseline score a covariate, treatment groups and regions as explanatory variables.|Asenapine 5 mg BID minus Placebo BID|||-1.41|-3.53|<0.0001
72563593|NCT01098110|144658351|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-3.03|STANDARD_ERROR_OF_MEAN|0.54|<|0.0001|TWO_SIDED|95.0|-4.08|-1.97|||ANCOVA|Change from baseline a response variable, baseline score a covariate, treatment groups and regions as explanatory variables.|Asenapine 10 mg BID minus Placebo BID|||-1.97|-4.08|<0.0001
72563594|NCT01098110|144658352|SUPERIORITY_OR_OTHER_LEGACY||Least square (LS) means difference|-5.46|STANDARD_ERROR_OF_MEAN|1.07|<|0.0001|TWO_SIDED|95.0|-7.56|-3.35|||ANCOVA|Change from baseline a response variable, baseline score a covariate, treatment groups and regions as explanatory variables.|Asenapine 5 mg BID minus Placebo BID|||-3.35|-7.56|<0.0001
72563595|NCT01098110|144658352|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-6.53|STANDARD_ERROR_OF_MEAN|1.06|<|0.0001|TWO_SIDED|95.0|-8.62|-4.44||Statistical significant: p=\<0.05, two sided|ANCOVA|Change from baseline a response variable, baseline score a covariate, treatment groups and regions as explanatory variables.|Asenapine 10 mg BID minus Placebo BID|||-4.44|-8.62|<0.0001
72563596|NCT01098110|144658353|SUPERIORITY_OR_OTHER_LEGACY||Least square (LS) means difference|-3.41|STANDARD_ERROR_OF_MEAN|0.67|<|0.0001|TWO_SIDED|95.0|-4.72|-2.09|||ANCOVA|Change from baseline a response variable, baseline score a covariate, treatment groups and regions as explanatory variables.|Asenapine 5 mg BID minus Placebo BID|||-2.09|-4.72|<0.0001
72392906|NCT00518986|144293366|SUPERIORITY_OR_OTHER|||||||0.0105|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0105
72392907|NCT00518986|144293367|SUPERIORITY_OR_OTHER|||||||0.2888|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.2888
72392908|NCT00518986|144293368|SUPERIORITY_OR_OTHER|||||||0.013|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0130
72563597|NCT01098110|144658353|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-3.66|STANDARD_ERROR_OF_MEAN|0.67|<|0.0001|TWO_SIDED|95.0|-4.97|-2.35|||ANCOVA|Change from baseline a response variable, baseline score a covariate, treatment groups and regions as explanatory variables.|Asenapine 10 mg BID minus Placebo BID|||-2.35|-4.97|<0.0001
72621078|NCT02732145|144773173|OTHER|"Question: Determination of positive predictive value of the N-S-P Scheme for detection of vulvar dermatosis in comparison to the histopathology results."|PPV (2x2 Table)|0.878|||||TWO_SIDED|95.0|0.227|1.0|||||"Positive predictive value of the N-S-P Scheme for Detection of Vulvar Dermatosis was 0.8780 (Range: 0.2270 - 1.0000)."|"Parameter: Positive predictive value of Three Rings Vulvoscopy for detection of vulvar dermatosis."||1.0000|0.2270|
72461650|NCT00113880|144445792|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.28||||0.01|TWO_SIDED|95.0|0.15|0.52||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Fisher Exact||Population: 5-8 yrs, within 180 days, PD2. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Asthma/Rad event rates were presented per 1,000 person-months.||0.52|0.15|0.01
72461651|NCT00113880|144445792|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.75||||0.01|TWO_SIDED|95.0|0.66|0.85||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Fisher Exact||Population: all ages, within 180 days, PD1. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Wheezing/SOB event rates were presented per 1,000 person-months.||0.85|0.66|0.01
72461652|NCT00113880|144445792|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.83||||0.02|TWO_SIDED|95.0|0.7|0.97||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Fisher Exact||Population: 5-8 yrs, within 180 days, PD1. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Wheezing/SOB event rates were presented per 1,000 person-months.||0.97|0.70|0.02
72461653|NCT00113880|144445792|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.72||||0.01|TWO_SIDED|95.0|0.58|0.88||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Fisher Exact||Population: 9-17 yrs, within 180 days, PD1. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Wheezing/SOB event rates were presented per 1,000 person-months.||0.88|0.58|0.01
72461654|NCT00113880|144445792|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.47||||0.01|TWO_SIDED|95.0|0.27|0.78||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Fisher Exact||Population: 18-49 yrs, within 180 days, PD1. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Wheezing/SOB event rates were presented per 1,000 person-months.||0.78|0.27|0.01
72461655|NCT00113880|144445793|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.0||||0.04|TWO_SIDED|95.0|0.0|0.82||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Fisher Exact||The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Encephalitis/encephalopathy event rates were presented per 1,000 person-months.||0.82|0.00|0.04
72461656|NCT00113880|144445794|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.65||||0.01|TWO_SIDED|95.0|0.47|0.91||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple confidence intervals (CIs) were constructed without multiplicity adjustment.|Regression, Cox||Population: all ages, within 21 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the unvaccinated controls represents the denominator.|SAE event rates were presented per 1,000 person-months.||0.91|0.47|0.01
72461657|NCT00113880|144445794|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.34||||0.01|TWO_SIDED|95.0|0.21|0.57||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment|Regression, Cox||Population: 18-49 yrs, within 21 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the unvaccinated controls represents the denominator.|SAE event rates were presented per 1,000 person-months.||0.57|0.21|0.01
72461658|NCT00113880|144445794|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.6||||0.01|TWO_SIDED|95.0|0.47|0.77||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Regression, Cox||Population: all ages, within 42 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the unvaccinated controls represents the denominator.|SAE event rates were presented per 1,000 person-months.||0.77|0.47|0.01
72461659|NCT00113880|144445794|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.33||||0.01|TWO_SIDED|95.0|0.23|0.48||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Regression, Cox||Population: 18-49 yrs, within 42 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the unvaccinated controls represents the denominator.|SAE event rates were presented per 1,000 person-months.||0.48|0.23|0.01
72501661|NCT00609622|144533218|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.25||||0.9635|TWO_SIDED|95.0|-16.26|15.76|||t-test, 2 sided|||Differences in EWB between treatment arms (C31 of D1) was analyzed from a two-sample t-test.||15.76|-16.26|0.9635
72501662|NCT00609622|144533218|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0|||<|0.0001|TWO_SIDED|95.0|0.0|0.0|||t-test, 2 sided|||Differences in EWB between treatment arms (C34 of D1) was analyzed from a two-sample t-test.||0|0|<0.0001
72501663|NCT00609622|144533218|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.42||||0.6699|TWO_SIDED|95.0|-2.37|1.53|||t-test, 2 sided|||Differences in EWB between treatment arms (EOT) was analyzed from a two-sample t-test.||1.53|-2.37|0.6699
72501664|NCT00609622|144533218|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.34||||0.0055|TWO_SIDED|95.0|-3.98|-0.7|||t-test, 2 sided|||Differences in FWB between treatment arms (C4 of D1) was analyzed from a two-sample t-test.||-0.70|-3.98|0.0055
72621079|NCT02732145|144773173|OTHER|"Question: Determination of negative predictive value of the N-S-P Scheme for detection of vulvar dermatosis in comparison to the histopathology results."|NPV (2x2 Table)|1.0|||||TWO_SIDED|95.0|1.0|1.0|||||"Negative predictive value of the N-S-P Scheme for Detection of Vulvar Dermatosis was 1.0000 (Range: 1.0000 - 1.0000)."|"Parameter: Negative predictive value of Three Rings Vulvoscopy for detection of vulvar dermatosis."||1.0000|1.0000|
72621080|NCT02732145|144773173|SUPERIORITY|"Question: Is there a difference in the diagnostic accuracy of the N-S-P Scheme as an outcome measure of the diagnostic value of Three Rings Vulvoscopy, and histopathology?"||||||0.6108|||||||t-test proportion|||"Parameter: The difference in the diagnostic accuracy between TRIV using the N-S-P Scheme and histopathology for detection of vulvar dermatosis."||||0.6108
72461660|NCT00113880|144445795|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.65||||0.01|TWO_SIDED|95.0|0.47|0.91||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple confidence intervals (CIs) were constructed without multiplicity adjustment.|Regression, Cox||Population: all ages, within 21 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the unvaccinated controls represents the denominator.|SAE event rates were presented per 1,000 person-months.||0.91|0.47|0.01
72461661|NCT00113880|144445795|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.34||||0.01|TWO_SIDED|95.0|0.21|0.57||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment|Regression, Cox||Population: 18-49 yrs, within 21 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the unvaccinated controls represents the denominator.|SAE event rates were presented per 1,000 person-months.||0.57|0.21|0.01
72461662|NCT00113880|144445795|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.6||||0.01|TWO_SIDED|95.0|0.47|0.77||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Regression, Cox||Population: all ages, within 42 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the unvaccinated controls represents the denominator.|SAE event rates were presented per 1,000 person-months.||0.77|0.47|0.01
72461663|NCT00113880|144445795|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.33||||0.01|TWO_SIDED|95.0|0.23|0.48||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Regression, Cox||Population: 18-49 yrs, within 42 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the unvaccinated controls represents the denominator.|SAE event rates were presented per 1,000 person-months.||0.48|0.23|0.01
72461664|NCT00113880|144445796|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.64||||0.01|TWO_SIDED|95.0|0.57|0.73||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple confidence intervals (CIs) were constructed without multiplicity adjustment.|Regression, Cox||Population: all ages, within 180 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the unvaccinated controls represents the denominator.|Hospitalization or death event rates were presented per 1,000 person-months.||0.73|0.57|0.01
72461665|NCT00113880|144445796|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.43||||0.01|TWO_SIDED|95.0|0.36|0.51||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment|Regression, Cox||Population: 18-49 yrs, within 180 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the unvaccinated controls represents the denominator.|Hospitalization or death event rates were presented per 1,000 person-months.||0.51|0.36|0.01
72461666|NCT00113880|144445797|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.29||||0.01|TWO_SIDED|95.0|0.26|0.33||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple confidence intervals (CIs) were constructed without multiplicity adjustment.|Regression, Cox||Population: all ages, within 180 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Hospitalization or death event rates were presented per 1,000 person-months.||0.33|0.26|0.01
72461667|NCT00113880|144445797|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.16||||0.01|TWO_SIDED|95.0|0.13|0.18||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment|Regression, Cox||Population: 18-49 yrs, within 180 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Hospitalization or death event rates were presented per 1,000 person-months.||0.18|0.13|0.01
72461668|NCT00113880|144445798|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.16||||0.04|TWO_SIDED|95.0|0.03|0.93||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Regression, Cox||Population: 18-49 within 21 days. The rate of events during the risk period represents the numerator; the rate of events during the control period represents the denominator.|Sinusitis event rates were presented per 1,000 person-months.||0.93|0.03|0.04
72461669|NCT00113880|144445798|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.6||||0.02|TWO_SIDED|95.0|0.4|0.92||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Regression, Cox||Population: all ages, within 21 days. The rate of events during the risk period represents the numerator; the rate of events during the control period represents the denominator.|URI event rates were presented per 1,000 person-months.||0.92|0.40|0.02
72461670|NCT00113880|144445798|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.49||||0.01|TWO_SIDED|95.0|0.28|0.84||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Fisher Exact||Population: 9-17 years, within 21 days. The rate of events during the risk period represents the numerator; the rate of events during the control period represents the denominator.|URI event rates were presented per 1,000 person-months.||0.84|0.28|0.01
72501665|NCT00609622|144533218|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.04||||0.2793|TWO_SIDED|95.0|-2.92|0.85|||t-test, 2 sided|||Differences in FWB between treatment arms (C7 of D1) was analyzed from a two-sample t-test.||0.85|-2.92|0.2793
72621081|NCT02732145|144773174|SUPERIORITY|"Question: Is there a difference in the frequency of N-#-# result (no lesions) of the Outer Vulvar Ring in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology?"||||||0.9286|||||||t-test proportion|||"Parameter: The difference in the frequency of N-#-# result (no lesions) of the Outer Vulvar Ring in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology."||||0.9286
72461671|NCT00113880|144445798|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.29||||0.02|TWO_SIDED|95.0|0.1|0.78||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Regression, Cox||Population: 18-49 years, within 21 days. The rate of events during the risk period represents the numerator; the rate of events during the control period represents the denominator.|URI event rates were presented per 1,000 person-months.||0.78|0.10|0.02
72461672|NCT00113880|144445798|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.78||||0.02|TWO_SIDED|95.0|0.63|0.96||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Fisher Exact||Population: all ages, within 21 days. The rate of events during the risk period represents the numerator; the rate of events during the control period represents the denominator.|Any acute resp. tract event rates were presented per 1,000 person-months.||0.96|0.63|0.02
72461673|NCT00113880|144445798|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.69||||0.03|TWO_SIDED|95.0|0.5|0.97||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Fisher Exact||Population: 9-17 years, within 21 days. The rate of events during the risk period represents the numerator; the rate of events during the control period represents the denominator.|Any acute resp. tract event rates were presented per 1,000 person-months.||0.97|0.50|0.03
72461674|NCT00113880|144445798|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.41||||0.01||95.0|0.21|0.79||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Regression, Cox||Population: 18-49 years, within 21 days. The rate of events during the risk period represents the numerator; the rate of events during the control period represents the denominator.|Any acute resp. tract event rates were presented per 1,000 person-months.||0.79|0.21|0.01
72461675|NCT00113880|144445799|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.95||||0.02|TWO_SIDED|95.0|1.14|3.34||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Regression, Cox||Population: all ages, within 42 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the unvaccinated controls represents the denominator.|Sinusitis event rates were presented per 1,000 person-months.||3.34|1.14|0.02
72461676|NCT00113880|144445799|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED|||||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Exact method or Cox model|||Irritable bowel syndrome event rates were presented per 1,000 person-months. If the control group has no event, the RR or HR is not estimable.||||0.02
72392909|NCT00518986|144293369|SUPERIORITY_OR_OTHER|||||||0.0354|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0354
72461677|NCT00113880|144445800|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.3||||0.01|TWO_SIDED|95.0|0.15|0.57||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Regression, Cox||Population: all ages, within 42 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Asthma/RAD event rates were presented per 1,000 person-months.||0.57|0.15|0.01
72501666|NCT00609622|144533218|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.09||||0.2999|TWO_SIDED|95.0|-3.17|0.99|||t-test, 2 sided|||Differences in FWB between treatment arms (C10 of D1) was analyzed from a two-sample t-test.||0.99|-3.17|0.2999
72501667|NCT00609622|144533218|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.27||||0.327|TWO_SIDED|95.0|-3.82|1.29|||t-test, 2 sided|||Differences in FWB between treatment arms (C13 of D1) was analyzed from a two-sample t-test.||1.29|-3.82|0.3270
72392910|NCT00518986|144293370|SUPERIORITY_OR_OTHER|||||||0.3854||||||P-value for the treatment comparison is from a Pearson's chi-square test|Chi-squared|||Responders are subjects with worst fatigue score \< 7 after baseline||||0.3854
72461678|NCT00113880|144445800|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.33||||0.03|TWO_SIDED|95.0|0.12|0.92||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Regression, Cox||Population: 5-8, within 42 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Asthma/RAD event rates were presented per 1,000 person-months.||0.92|0.12|0.03
72461679|NCT00113880|144445800|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.31||||0.01|TWO_SIDED|95.0|0.13|0.74||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Regression, Cox||Population: 9-17, within 42 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Asthma/RAD event rates were presented per 1,000 person-months.||0.74|0.13|0.01
72461680|NCT00113880|144445800|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.74||||0.04|TWO_SIDED|95.0|0.55|0.99||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Regression, Cox||Population: all ages, within 42 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Pharyngitis event rates were presented per 1,000 person-months.||0.99|0.55|0.04
72501668|NCT00609622|144533218|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.03||||0.9779|TWO_SIDED|95.0|-2.39|2.45|||t-test, 2 sided|||Differences in FWB between treatment arms (C16 of D1) was analyzed from a two-sample t-test.||2.45|-2.39|0.9779
72501669|NCT00609622|144533218|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.4||||0.8344|TWO_SIDED|95.0|-4.25|3.45|||t-test, 2 sided|||Differences in FWB between treatment arms (C19 of D1) was analyzed from a two-sample t-test.||3.45|-4.25|0.8344
72392911|NCT00518986|144293371|SUPERIORITY_OR_OTHER|||||||0.0145||||||P-value for the treatment comparison is from Pearson's chi-square test|Chi-squared|||Responders were defined as subjects with worst fatigue score \< 7||||0.0145
72392912|NCT00518986|144293372|SUPERIORITY_OR_OTHER|||||||0.6475||||||P-value for the treatment comparison is from a Pearson's chi-square test|Chi-squared|||Responders were patients with worst fatigue scores \< 7||||0.6475
72461681|NCT00113880|144445800|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.36||||0.04|TWO_SIDED|95.0|0.14|0.93||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Regression, Cox||Population: 18-49 years, within 42 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Pharyngitis event rates were presented per 1,000 person-months.||0.93|0.14|0.04
72461682|NCT00113880|144445800|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.83||||0.02|TWO_SIDED|95.0|0.71|0.97||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Regression, Cox||Population: all ages, within 42 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Any acute respiratory tract event rates were presented per 1,000 person-months.||0.97|0.71|0.02
72461683|NCT00113880|144445800|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.73||||0.01|TWO_SIDED|95.0|0.57|0.92||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Regression, Cox||Population: 9-17, within 42 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Any acute respiratory tract event rates were presented per 1,000 person-months.||0.92|0.57|0.01
72461684|NCT00113880|144445800|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.36||||0.01|TWO_SIDED|95.0|0.22|0.61||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Regression, Cox||Population: all ages, within 42 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Any asthma or wheezing event rates were presented per 1,000 person-months.||0.61|0.22|0.01
72461685|NCT00113880|144445800|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.33||||0.01|TWO_SIDED|95.0|0.16|0.68||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Regression, Cox||Population: 9-17, within 42 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Any asthma or wheezing event rates were presented per 1,000 person-months.||0.68|0.16|0.01
72461686|NCT00113880|144445800|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.0||||0.03|TWO_SIDED|95.0|0.0|0.82|||Fisher Exact||Population: 18-49, within 42 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Any asthma or wheezing event rates were presented per 1,000 person-months.||0.82|0.00|0.03
72461687|NCT00113880|144445801|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.72||||0.01|TWO_SIDED|95.0|0.58|0.91||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Regression, Cox||Population: all ages, within 180 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the unvaccinated controls represents the denominator.|Asthma/RAD event rates were presented per 1,000 person-months.||0.91|0.58|0.01
72461688|NCT00113880|144445801|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.67||||0.01|TWO_SIDED|95.0|0.49|0.91||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Regression, Cox||Population: 9-17 years, within 180 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the unvaccinated controls represents the denominator.|Asthma/RAD event rates were presented per 1,000 person-months.||0.91|0.49|0.01
72461689|NCT00113880|144445801|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.75||||0.01|TWO_SIDED|95.0|0.61|0.92||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Regression, Cox||Population: all ages, within 180 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the unvaccinated controls represents the denominator.|Any asthma or wheezing event rates were presented per 1,000 person-months.||0.92|0.61|0.01
72461690|NCT00113880|144445801|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.69||||0.01|TWO_SIDED|95.0|0.52|0.91||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Regression, Cox||Population: 9-17 years, within 180 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the unvaccinated controls represents the denominator.|Any asthma or wheezing event rates were presented per 1,000 person-months.||0.91|0.52|0.01
72461691|NCT00113880|144445802|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.41||||0.01|TWO_SIDED|95.0|0.33|0.51||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Regression, Cox||Population: all ages, within 180 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Asthma/RAD event rates were presented per 1,000 person-months.||0.51|0.33|0.01
72501670|NCT00609622|144533218|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.46||||0.5494|TWO_SIDED|95.0|-3.5|6.41|||t-test, 2 sided|||Differences in FWB between treatment arms (C22 of D1) was analyzed from a two-sample t-test.||6.41|-3.50|0.5494
72501671|NCT00609622|144533218|SUPERIORITY_OR_OTHER||Mean Difference (Net)|13.0||||0.0136|TWO_SIDED|95.0|3.15|22.85|||t-test, 2 sided|||Differences in FWB between treatment arms (C25 of D1) was analyzed from a two-sample t-test.||22.85|3.15|0.0136
72501672|NCT00609622|144533218|SUPERIORITY_OR_OTHER||Mean Difference (Net)|13.78||||0.0247|TWO_SIDED|95.0|2.26|25.29|||t-test, 2 sided|||Differences in FWB between treatment arms (C28 of D1) was analyzed from a two-sample t-test.||25.29|2.26|0.0247
72501673|NCT00609622|144533218|SUPERIORITY_OR_OTHER||Mean Difference (Net)|5.0||||0.3527|TWO_SIDED|95.0|-12.91|22.91|||t-test, 2 sided|||Differences in FWB between treatment arms (C31 of D1) was analyzed from a two-sample t-test.||22.91|-12.91|0.3527
72501674|NCT00609622|144533218|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0|||<|0.0001|TWO_SIDED|95.0|0.0|0.0|||t-test, 2 sided|||Differences in FWB between treatment arms (C34 of D1) was analyzed from a two-sample t-test.||0|0|<0.0001
72392913|NCT00518986|144293373|SUPERIORITY_OR_OTHER|||||||0.0118||||||P-value for the treatment comparison is from Pearson's chi-square test|Chi-squared|||Responders are subjects with worst fatigue score \< 7||||0.0118
72461692|NCT00113880|144445802|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.37||||0.01|TWO_SIDED|95.0|0.26|0.55||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Regression, Cox||Population: 5-8 years, within 180 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Asthma/RAD event rates were presented per 1,000 person-months.||0.55|0.26|0.01
72461693|NCT00113880|144445802|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.42||||0.01|TWO_SIDED|95.0|0.31|0.56||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Regression, Cox||Population: 9-17 years, within 180 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Asthma/RAD event rates were presented per 1,000 person-months.||0.56|0.31|0.01
72461694|NCT00113880|144445802|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.29||||0.02|TWO_SIDED|95.0|0.26|0.91||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Regression, Cox||Population: 18-49 years, within 180 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Asthma/RAD event rates were presented per 1,000 person-months.||0.91|0.26|0.02
72461695|NCT00113880|144445802|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.45||||0.01||95.0|0.37|0.55||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Regression, Cox||Population: all ages, within 180 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Any asthma or wheezing event rates were presented per 1,000 person-months.||0.55|0.37|0.01
72461696|NCT00113880|144445802|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.49||||0.01|TWO_SIDED|95.0|0.35|0.67||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Regression, Cox||Population: 5-8 years, within 180 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Any asthma or wheezing event rates were presented per 1,000 person-months.||0.67|0.35|0.01
72461697|NCT00113880|144445802|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.43||||0.01|TWO_SIDED|95.0|0.33|0.56||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Regression, Cox||Population: 9-17 years, within 180 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Any asthma or wheezing event rates were presented per 1,000 person-months.||0.56|0.33|0.01
72461698|NCT00113880|144445802|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.46||||0.01|TWO_SIDED|95.0|0.25|0.85||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Regression, Cox||Population: 18-49 years, within 180 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Any asthma or wheezing event rates were presented per 1,000 person-months.||0.85|0.25|0.01
72461699|NCT00113880|144445803|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.47||||0.01|TWO_SIDED|95.0|0.32|0.69||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple confidence intervals (CIs) were constructed without multiplicity adjustment.|Regression, Cox||Population: all ages, within 180 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Hospitalization or death event rates were presented per 1,000 person-months.||0.69|0.32|0.01
72461700|NCT00113880|144445803|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.31||||0.01|TWO_SIDED|95.0|0.17|0.54||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment|Regression, Cox||Population: 18-49 yrs, within 180 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Hospitalization or death event rates were presented per 1,000 person-months.||0.54|0.17|0.01
72461701|NCT01636258|144445828|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.3|STANDARD_DEVIATION|2.1||0.72|TWO_SIDED|95.0|-1.4|2.0||P-value less than 0.05 considered statistically significant a priori. No multiple comparison adjustment made.|t-test, 2 sided|||No sample size calculation performed since it was a pilot study. Null hypothesis was no difference between groups.||2.0|-1.4|0.72
72461702|NCT01636258|144445829|SUPERIORITY_OR_OTHER_LEGACY|||||||0.31|||||||Wilcoxon (Mann-Whitney)|||No sample study calculation performed since it was a pilot study. Null hypothesis was no difference between groups.||||0.31
72501675|NCT00609622|144533218|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.76||||0.1309|TWO_SIDED|95.0|-4.05|0.53|||t-test, 2 sided|||Differences in FWB between treatment arms (EOT) was analyzed from a two-sample t-test.||0.53|-4.05|0.1309
72501676|NCT00609622|144533218|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.36||||0.051|TWO_SIDED|95.0|-2.72|0.01|||t-test, 2 sided|||Differences in CCS between treatment arms (C4 of D1) was analyzed from a two-sample t-test.||0.01|-2.72|0.0510
72501677|NCT00609622|144533218|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.74||||0.3858|TWO_SIDED|95.0|-2.44|0.95|||t-test, 2 sided|||Differences in CCS between treatment arms (C7 of D1) was analyzed from a two-sample t-test.||0.95|-2.44|0.3858
72501678|NCT00609622|144533218|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.88||||0.3943|TWO_SIDED|95.0|-2.9|1.15|||t-test, 2 sided|||Differences in CCS between treatment arms (C10 of D1) was analyzed from a two-sample t-test.||1.15|-2.90|0.3943
72563598|NCT01098110|144658354|SUPERIORITY_OR_OTHER_LEGACY||Least square (LS) means difference|-2.36|STANDARD_ERROR_OF_MEAN|0.56|<|0.0001|TWO_SIDED|95.0|-3.47|-1.26|||ANCOVA|Change from baseline a response variable, baseline score a covariate.|Asenapine 5 mg BID minus Placebo BID|||-1.26|-3.47|<0.0001
72392914|NCT00518986|144293374|SUPERIORITY_OR_OTHER|||||||0.3483||||||P-value for the treatment comparison is from the Pearson's chi-square test.|Chi-squared|||Responders are subjects with a worst fatigue score of \< 7||||0.3483
72461703|NCT01636258|144445830|SUPERIORITY_OR_OTHER_LEGACY|||||||0.31|||||||Wilcoxon (Mann-Whitney)|||||||0.31
72461704|NCT01636258|144445831|SUPERIORITY_OR_OTHER_LEGACY|||||||0.53|||||||Wilcoxon (Mann-Whitney)|||||||0.53
72392915|NCT00518986|144293375|SUPERIORITY_OR_OTHER|||||||0.0879|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0879
72392916|NCT00518986|144293376|SUPERIORITY_OR_OTHER|||||||0.0277|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0277
72392917|NCT00518986|144293377|SUPERIORITY_OR_OTHER|||||||0.1245|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.1245
72461705|NCT01763346|144445833|SUPERIORITY|||||||0.05||||||35 subjects per group provided 80% power to detect an effect size of 0.59, assuming a 2-sided p=0.05, adjustment for baseline measures using ANCOVA, and correlation of 0.5 between baseline and end-study measures.|General Linear Models|Differences in primary outcomes between groups at 24-months were compared using general linear models with baseline values included as covariates.||We selected a sample size that would allow detection of an effect size of \~0.6 or greater between gastric band and metformin groups for measures of β-cell function after two years, hypothesizing greater function in the gastric band group.||||0.05
72461706|NCT00116584|144445856|SUPERIORITY||||||<|0.05|||||||Fisher Exact|||||||<0.05
72461707|NCT00116584|144445857|SUPERIORITY||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
72461708|NCT00116584|144445858|SUPERIORITY||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
72461709|NCT02186015|144445865|SUPERIORITY|A Wilcoxon signed rank test was performed.|||||<|0.01|||||||Wilcoxon signed rank test|||The null hypothesis is that there is 0 change in serum 25(OH)D from week 0 to week 8.||||<0.01
72461710|NCT02186015|144445866|SUPERIORITY|A Wilcoxon signed rank test was performed.||||||0.24|||||||Wilcoxon signed rank test|||The null hypothesis is that there is 0 change in worst pain rating from week 0 to week 8.||||0.24
72461711|NCT02186015|144445867|SUPERIORITY|||||||0.09|||||||Wilcoxon signed rank test|||The null hypothesis is that there is 0 change in fatigue score from week 0 to week 8.||||0.09
72461712|NCT02186015|144445868|SUPERIORITY|||||||0.17|||||||Wilcoxon signed rank test|||The null hypothesis is that there is 0 change in mood score from week 0 to week 8.||||0.17
72461713|NCT02186015|144445869|SUPERIORITY|||||||0.5|||||||Wilcoxon signed rank test|||The null hypothesis is that there is 0 change in dominant handgrip strength from week 0 to week 8.||||0.50
72461714|NCT02186015|144445870|SUPERIORITY|||||||0.16|||||||Wilcoxon signed rank test|||The null hypothesis is that there is 0 change in sleep quality assessment from week 0 to week 8.||||0.16
72461715|NCT02186015|144445871|SUPERIORITY|||||||0.75|||||||Wilcoxon signed rank test|||The null hypothesis is that there is 0 change in functional assessment of cancer therapy-breast score from week 0 to week 8.||||0.75
72501679|NCT00609622|144533218|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.13||||0.3499|TWO_SIDED|95.0|-3.53|1.27|||t-test, 2 sided|||Differences in CCS between treatment arms (C13 of D1) was analyzed from a two-sample t-test.||1.27|-3.53|0.3499
72501680|NCT00609622|144533218|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.07||||0.9567|TWO_SIDED|95.0|-2.64|2.5|||t-test, 2 sided|||Differences in CCS between treatment arms (C16 of D1) was analyzed from a two-sample t-test.||2.50|-2.64|0.9567
72501681|NCT00609622|144533218|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.77||||0.2901|TWO_SIDED|95.0|-5.12|1.58|||t-test, 2 sided|||Differences in CCS between treatment arms (C19 of D1) was analyzed from a two-sample t-test.||1.58|-5.12|0.2901
72392918|NCT00518986|144293378|SUPERIORITY_OR_OTHER|||||||0.0305|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0305
72392919|NCT00518986|144293379|SUPERIORITY_OR_OTHER|||||||0.0129|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0129
72461716|NCT02186015|144445872|SUPERIORITY|||||||0.19|||||||Wilcoxon signed rank test|||The null hypothesis is that there is 0 change in functional assessment of cancer therapy-endocrine score from week 0 to week 8.||||0.19
72461717|NCT02592434|144445902|SUPERIORITY||Difference in percentage|-23.69||||0.0031|TWO_SIDED|95.0|-39.41|-7.97||Threshold for significance at 0.05 level.|Normal approximation to the binomial|||In order to preserve type I error, each endpoint assessed sequentially using gate-keeping or step-down approach where statistical significance was claimed for the second endpoint only if the first endpoint in the sequence meets the requirements for significance.||-7.97|-39.41|0.0031
72461718|NCT02592434|144445903|SUPERIORITY||Difference in percentage|19.52||||0.0166|TWO_SIDED|95.0|3.55|35.5||Threshold for significance at 0.05 level.|Normal approximation to the binomial|||In order to preserve type I error, each endpoint assessed sequentially using gate-keeping or step-down approach where statistical significance was claimed for the second endpoint only if the first endpoint in the sequence meets the requirements for significance.||35.50|3.55|0.0166
72461719|NCT02592434|144445904|SUPERIORITY||Difference in percentage|23.69||||0.0031|TWO_SIDED|95.0|7.97|39.41||Threshold for significance at 0.05 level.|Normal approximation to the binomial|||In order to preserve type I error, each endpoint assessed sequentially using gate-keeping or step-down approach where statistical significance was claimed for the second endpoint only if the first endpoint in the sequence meets the requirements for significance.||39.41|7.97|0.0031
72461720|NCT02592434|144445905|SUPERIORITY||Difference in percentage|17.02||||0.0387|TWO_SIDED|95.0|0.88|33.17||Threshold for significance at 0.05 level.|Normal approximation to the binomial|||In order to preserve type I error, each endpoint assessed sequentially using gate-keeping or step-down approach where statistical significance was claimed for the second endpoint only if the first endpoint in the sequence meets the requirements for significance.||33.17|0.88|0.0387
72501682|NCT00609622|144533218|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.07||||0.5857|TWO_SIDED|95.0|-5.05|2.92|||t-test, 2 sided|||Differences in CCS between treatment arms (C22 of D1) was analyzed from a two-sample t-test.||2.92|-5.05|0.5857
72461721|NCT02592434|144445906|SUPERIORITY||Ls mean difference|-0.12|STANDARD_ERROR_OF_MEAN|0.05||0.0292|TWO_SIDED|95.0|-0.22|-0.01||Threshold for significance at 0.05 level.|Mixed Model for Repeated Measures (MMRM)|||In order to preserve type I error, each endpoint assessed sequentially using gate-keeping or step-down approach where statistical significance was claimed for the second endpoint only if the first endpoint in the sequence meets the requirements for significance. Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the Double-Blind baseline value.||-0.01|-0.22|0.0292
72461722|NCT02592434|144445908|SUPERIORITY||Difference in percentage|-1.71||||0.741|TWO_SIDED|95.0|-11.82|8.41|||Normal approximation to the binomial|||at Week 20||8.41|-11.82|0.7410
72461723|NCT02592434|144445908|SUPERIORITY||Difference in percentage|-18.93||||0.0052|TWO_SIDED|95.0|-32.22|-5.64|||Normal approximation to the binomial|||at Week 24||-5.64|-32.22|0.0052
72461724|NCT02592434|144445908|SUPERIORITY||Difference in percentage|-19.09||||0.0093|TWO_SIDED|95.0|-33.48|-4.7|||Normal approximation to the binomial|||at Week 28||-4.70|-33.48|0.0093
72461725|NCT02592434|144445908|SUPERIORITY||Difference in percentage|-22.1||||0.0045|TWO_SIDED|95.0|-37.35|-6.86|||Normal approximation to the binomial|||at Week 32||-6.86|-37.35|0.0045
72461726|NCT02592434|144445908|SUPERIORITY||Difference in percentage|-23.57||||0.0027|TWO_SIDED|95.0|-38.97|-8.17|||Normal approximation to the binomial|||at Week 36||-8.17|-38.97|0.0027
72461727|NCT02592434|144445908|SUPERIORITY||Difference in percentage|-25.08||||0.0016|TWO_SIDED|95.0|-40.69|-9.47|||Normal approximation to the binomial|||at Week 40||-9.47|-40.69|0.0016
72461728|NCT02592434|144445912|SUPERIORITY||Difference in percentage|6.03||||0.301|TWO_SIDED|95.0|-5.4|17.46|||Normal approximation to the binomial|||at Week 20||17.46|-5.40|0.3010
72461729|NCT02592434|144445912|SUPERIORITY||Difference in percentage|17.54||||0.0108|TWO_SIDED|95.0|4.05|31.03|||Normal approximation to the binomial|||at Week 24||31.03|4.05|0.0108
72461730|NCT02592434|144445912|SUPERIORITY||Difference in percentage|19.13||||0.0103|TWO_SIDED|95.0|4.51|33.74|||Normal approximation to the binomial|||at Week 28||33.74|4.51|0.0103
72461731|NCT02592434|144445912|SUPERIORITY||Difference in percentage|23.53||||0.0025|TWO_SIDED|95.0|8.27|38.8|||Normal approximation to the binomial|||at Week 32||38.80|8.27|0.0025
72461732|NCT02592434|144445912|SUPERIORITY||Difference in percentage|25.04||||0.0016|TWO_SIDED|95.0|9.52|40.56|||Normal approximation to the binomial|||at Week 36||40.56|9.52|0.0016
72461733|NCT02592434|144445912|SUPERIORITY||Difference in percentage|23.69||||0.0031|TWO_SIDED|95.0|7.97|39.41|||Normal approximation to the binomial|||at Week 40||39.41|7.97|0.0031
72461734|NCT02592434|144445914|SUPERIORITY||Difference in percentage|-1.15||||0.8119|TWO_SIDED|95.0|-10.63|8.33|||Normal approximation for binomial|||Double Blind Baseline (Week 18)||8.33|-10.63|0.8119
72501683|NCT00609622|144533218|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.27||||0.9635|TWO_SIDED|95.0|-12.56|12.02|||t-test, 2 sided|||Differences in CCS between treatment arms (C25 of D1) was analyzed from a two-sample t-test.||12.02|-12.56|0.9635
72461735|NCT02592434|144445914|SUPERIORITY||Difference in percentage|7.66||||0.2682|TWO_SIDED|95.0|-5.9|21.21|||Normal approximation for binomial|||Week 20||21.21|-5.90|0.2682
72501684|NCT00609622|144533218|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.4||||0.685|TWO_SIDED|95.0|-15.36|10.56|||t-test, 2 sided|||Differences in CCS between treatment arms (C28 of D1) was analyzed from a two-sample t-test.||10.56|-15.36|0.6850
72501685|NCT00609622|144533218|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.75||||0.4968|TWO_SIDED|95.0|-19.23|11.73|||t-test, 2 sided|||Differences in CCS between treatment arms (C31 of D1) was analyzed from a two-sample t-test.||11.73|-19.23|0.4968
72501686|NCT00609622|144533218|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0|||<|0.0001|TWO_SIDED|95.0|0.0|0.0|||t-test, 2 sided|||Differences in CCS between treatment arms (C34 of D1) was analyzed from a two-sample t-test.||0|0|<0.0001
72461736|NCT02592434|144445914|SUPERIORITY||Difference in percentage|21.98||||0.0034|TWO_SIDED|95.0|7.26|36.71|||Normal approximation for binomial|||Week 24||36.71|7.26|0.0034
72461737|NCT02592434|144445914|SUPERIORITY||Difference in percentage|17.9||||0.0233|TWO_SIDED|95.0|2.44|33.36|||Normal approximation for binomial|||Week 28||33.36|2.44|0.0233
72461738|NCT02592434|144445914|SUPERIORITY||Difference in percentage|25.16||||0.0018|TWO_SIDED|95.0|9.39|40.93|||Normal approximation for binomial|||Week 32||40.93|9.39|0.0018
72461739|NCT02592434|144445914|SUPERIORITY||Difference in percentage|20.91||||0.0099|TWO_SIDED|95.0|5.01|36.81|||Normal approximation for binomial|||Week 36||36.81|5.01|0.0099
72461740|NCT02592434|144445914|SUPERIORITY||Difference in percentage|22.34||||0.0058|TWO_SIDED|95.0|6.46|38.22|||Normal approximation for binomial|||Week 40||38.22|6.46|0.0058
72461741|NCT02592434|144445916|SUPERIORITY||Difference in percentage|3.77||||0.6348|TWO_SIDED|95.0|-11.79|19.33|||Normal approximation to the binomial|||Double Blind Baseline (Week 18)||19.33|-11.79|0.6348
72461742|NCT02592434|144445916|SUPERIORITY||Difference in percentage|2.62||||0.7525|TWO_SIDED|95.0|-13.66|18.9|||Normal approximation to the binomial|||Week 20||18.90|-13.66|0.7525
72461743|NCT02592434|144445916|SUPERIORITY||Difference in percentage|14.05||||0.0908|TWO_SIDED|95.0|-2.23|30.33|||Normal approximation to the binomial|||Week 24||30.33|-2.23|0.0908
72461744|NCT02592434|144445916|SUPERIORITY||Difference in percentage|7.02||||0.4026|TWO_SIDED|95.0|-9.38|23.43|||Normal approximation to the binomial|||Week 28||23.43|-9.38|0.4026
72461745|NCT02592434|144445916|SUPERIORITY||Difference in percentage|18.37||||0.0258|TWO_SIDED|95.0|2.22|34.52|||Normal approximation to the binomial|||Week 32||34.52|2.22|0.0258
72461746|NCT02592434|144445916|SUPERIORITY||Difference in percentage|19.88||||0.0149|TWO_SIDED|95.0|3.88|35.88|||Normal approximation to the binomial|||Week 36||35.88|3.88|0.0149
72461747|NCT02592434|144445916|SUPERIORITY||Difference in percentage|19.88||||0.0149|TWO_SIDED|95.0|3.88|35.88|||Normal approximation to the binomial|||Week 40||35.88|3.88|0.0149
72461748|NCT02592434|144445918|SUPERIORITY||Difference in percentage|-5.24||||0.515|TWO_SIDED|95.0|-21.0|10.53|||Normal approximation to the binomial|||Double Blind Baseline (Week 18)||10.53|-21.00|0.5150
72461749|NCT02592434|144445918|SUPERIORITY||Difference in percentage|9.01||||0.24||95.0|-6.02|24.03|||Normal approximation to the binomial|||Week 20||24.03|-6.02|0.2400
72392920|NCT00518986|144293380|SUPERIORITY_OR_OTHER|||||||0.0308||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0308
72461750|NCT02592434|144445918|SUPERIORITY||Difference in percentage|8.93||||0.2557|TWO_SIDED|95.0|-6.47|24.33|||Normal approximation to the binomial|||Week 24||24.33|-6.47|0.2557
72461751|NCT02592434|144445918|SUPERIORITY||Difference in percentage|8.97||||0.2481|TWO_SIDED|95.0|-6.25|24.19|||Normal approximation to the binomial|||Week 28||24.19|-6.25|0.2481
72461752|NCT02592434|144445918|SUPERIORITY||Difference in percentage|16.03||||0.0356|TWO_SIDED|95.0|1.08|30.98|||Normal approximation to the binomial|||Week 32||30.98|1.08|0.0356
72461753|NCT02592434|144445918|SUPERIORITY||Difference in percentage|18.89||||0.0115|TWO_SIDED|95.0|4.24|33.54|||Normal approximation to the binomial|||Week 36||33.54|4.24|0.0115
72461754|NCT02592434|144445918|SUPERIORITY||Difference in percentage|11.87||||0.115|TWO_SIDED|95.0|-2.89|26.62|||Normal approximation to the binomial|||Week 40||26.62|-2.89|0.1150
72461755|NCT02592434|144445918|SUPERIORITY||Difference in percentage|13.29||||0.0744|TWO_SIDED|95.0|-1.31|27.9|||Normal approximation to the binomial|||Week 44||27.90|-1.31|0.0744
72461756|NCT02592434|144445920|SUPERIORITY||Difference in percentage|-16.15||||0.0207|TWO_SIDED|95.0|-29.84|-2.46|||Normal approximation to the binomial|||Double Blind Baseline (Week 18)||-2.46|-29.84|0.0207
72461757|NCT02592434|144445920|SUPERIORITY||Difference in percentage|10.63||||0.1254|TWO_SIDED|95.0|-2.97|24.24|||Normal approximation to the binomial|||Week 20||24.24|-2.97|0.1254
72501687|NCT00609622|144533218|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.58||||0.5891|TWO_SIDED|95.0|-2.71|1.55|||t-test, 2 sided|||Differences in CCS between treatment arms (EOT) was analyzed from a two-sample t-test.||1.55|-2.71|0.5891
72501688|NCT00609622|144533219|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.63||||0.5081|TWO_SIDED|95.0|-2.5|1.24|||t-test, 2 sided|||Differences in neurotoxicity between treatment arms (C4 of D1) was analyzed from a two-sample t-test.||1.24|-2.50|0.5081
72501689|NCT00609622|144533219|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.44||||0.6977|TWO_SIDED|95.0|-2.67|1.79|||t-test, 2 sided|||Differences in neurotoxicity between treatment arms (C7 of D1) was analyzed from a two-sample t-test.||1.79|-2.67|0.6977
72501690|NCT00609622|144533219|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.76||||0.0797|TWO_SIDED|95.0|-5.85|0.33|||t-test, 2 sided|||Differences in neurotoxicity between treatment arms (C10 of D1) was analyzed from a two-sample t-test.||0.33|-5.85|0.0797
72501691|NCT00609622|144533219|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.22||||0.5808|TWO_SIDED|95.0|-5.62|3.17|||t-test, 2 sided|||Differences in neurotoxicity between treatment arms (C13 of D1) was analyzed from a two-sample t-test.||3.17|-5.62|0.5808
72461758|NCT02592434|144445920|SUPERIORITY||Difference in percentage|3.49||||0.635|TWO_SIDED|95.0|-10.93|17.91|||Normal approximation to the binomial|||Week 24||17.91|-10.93|0.6350
72461759|NCT02592434|144445920|SUPERIORITY||Difference in percentage|2.1||||0.7732|TWO_SIDED|95.0|-12.2|16.41|||Normal approximation to the binomial|||Week 28||16.41|-12.20|0.7732
72501692|NCT00609622|144533219|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.03||||0.7046|TWO_SIDED|95.0|-6.44|4.38|||t-test, 2 sided|||Differences in neurotoxicity between treatment arms (C16 of D1) was analyzed from a two-sample t-test.||4.38|-6.44|0.7046
72501693|NCT00609622|144533219|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.18||||0.2052|TWO_SIDED|95.0|-2.4|10.76|||t-test, 2 sided|||Differences in neurotoxicity between treatment arms (C19 of D1) was analyzed from a two-sample t-test.||10.76|-2.40|0.2052
72501694|NCT00609622|144533219|SUPERIORITY_OR_OTHER||Mean Difference (Net)|8.27||||0.0483|TWO_SIDED|95.0|0.07|16.46|||t-test, 2 sided|||Differences in neurotoxicity between treatment arms (C22 of D1) was analyzed from a two-sample t-test.||16.46|0.07|0.0483
72501695|NCT00609622|144533219|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.93||||0.6832|TWO_SIDED|95.0|-16.41|24.26|||t-test, 2 sided|||Differences in neurotoxicity between treatment arms (C25 of D1) was analyzed from a two-sample t-test.||24.26|-16.41|0.6832
72501696|NCT00609622|144533219|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.0||||0.9081|TWO_SIDED|95.0|-18.05|20.05|||t-test, 2 sided|||Differences in neurotoxicity between treatment arms (C28 of D1) was analyzed from a two-sample t-test.||20.05|-18.05|0.9081
72461760|NCT02592434|144445920|SUPERIORITY||Difference in percentage|6.35||||0.3782|TWO_SIDED|95.0|-7.77|20.47|||Normal approximation to the binomial|||Week 32||20.47|-7.77|0.3782
72461761|NCT02592434|144445920|SUPERIORITY||Difference in percentage|11.98||||0.0936|TWO_SIDED|95.0|-2.02|25.99|||Normal approximation to the binomial|||Week 36||25.99|-2.02|0.0936
72461762|NCT02592434|144445920|SUPERIORITY||Difference in percentage|9.17||||0.2017|TWO_SIDED|95.0|-4.91|23.24|||Normal approximation to the binomial|||Week 40||23.24|-4.91|0.2017
72461763|NCT02592434|144445920|SUPERIORITY||Difference in percentage|12.02||||0.0858|TWO_SIDED|95.0|-1.69|25.74|||Normal approximation to the binomial|||Week 44||25.74|-1.69|0.0858
72461764|NCT02592434|144445922|SUPERIORITY||LS mean difference|-2.07|STANDARD_ERROR_OF_MEAN|0.78||0.0088|TWO_SIDED|95.0|-3.6|-0.53|||MMRM|||Week 20; Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.||-0.53|-3.60|0.0088
72461765|NCT02592434|144445922|SUPERIORITY||LS mean difference|-3.64|STANDARD_ERROR_OF_MEAN|1.28||0.0054|TWO_SIDED|95.0|-6.17|-1.1|||MMRM|||Week 24: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.||-1.10|-6.17|0.0054
72461766|NCT02592434|144445922|SUPERIORITY||LS mean difference|-3.85|STANDARD_ERROR_OF_MEAN|1.25||0.0039|TWO_SIDED|95.0|-6.38|-1.32|||MMRM|||Week 28: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.||-1.32|-6.38|0.0039
72461767|NCT02592434|144445922|SUPERIORITY||LS mean difference|-3.3|STANDARD_ERROR_OF_MEAN|0.98||0.0022|TWO_SIDED|95.0|-5.3|-1.29|||MMRM|||Week 32: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.||-1.29|-5.30|0.0022
72461768|NCT02592434|144445922|SUPERIORITY||LS mean difference|-6.21|STANDARD_ERROR_OF_MEAN|1.57||0.0005|TWO_SIDED|95.0|-9.42|-3.0|||MMRM|||Week 36: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.||-3.00|-9.42|0.0005
72461769|NCT02592434|144445922|SUPERIORITY||LS mean difference|-6.26|STANDARD_ERROR_OF_MEAN|1.63||0.0006|TWO_SIDED|95.0|-9.6|-2.92|||MMRM|||Week 40: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.||-2.92|-9.60|0.0006
72461770|NCT02592434|144445922|SUPERIORITY||LS mean difference|-4.36|STANDARD_ERROR_OF_MEAN|1.27||0.0027|TWO_SIDED|95.0|-7.02|-1.71|||MMRM|||Week 44: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.||-1.71|-7.02|0.0027
72461771|NCT02592434|144445924|SUPERIORITY||LS Mean Difference|-1.83|STANDARD_ERROR_OF_MEAN|0.76||0.0172|TWO_SIDED|95.0|-3.32|-0.33|||MMRM|||Week 20: Analysis was based on Mixed Model for Repeated Measures (MMRM) with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the Double-Blind baseline value.||-0.33|-3.32|0.0172
72461772|NCT02592434|144445924|SUPERIORITY||LS Mean Difference|-3.41|STANDARD_ERROR_OF_MEAN|1.21||0.0057|TWO_SIDED|95.0|-5.81|-1.01|||MMRM|||Week 24: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the Double-Blind baseline value.||-1.01|-5.81|0.0057
72501697|NCT00609622|144533219|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.75||||0.7289|TWO_SIDED|95.0|-12.88|16.38|||t-test, 2 sided|||Differences in neurotoxicity between treatment arms (C31 of D1) was analyzed from a two-sample t-test.||16.38|-12.88|0.7289
72501698|NCT00609622|144533219|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0|||<|0.0001|TWO_SIDED|95.0|0.0|0.0|||t-test, 2 sided|||Differences in neurotoxicity between treatment arms (C34 of D1) was analyzed from a two-sample t-test.||0|0|<0.0001
72501699|NCT00609622|144533219|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.74||||0.6921|TWO_SIDED|95.0|-4.43|2.95|||t-test, 2 sided|||Differences in neurotoxicity between treatment arms (EOT) was analyzed from a two-sample t-test.||2.95|-4.43|0.6921
72501700|NCT00609622|144533219|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0||||0.9788|TWO_SIDED|95.0|-0.19|0.19|||t-test, 2 sided|||Differences in item 13 between treatment arms (C4 of D1) was analyzed from a two-sample t-test.||0.19|-0.19|0.9788
72501701|NCT00609622|144533219|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.12||||0.2747|TWO_SIDED|95.0|-0.33|0.09|||t-test, 2 sided|||Differences in item 13 between treatment arms (C7 of D1) was analyzed from a two-sample t-test.||0.09|-0.33|0.2747
72461773|NCT02592434|144445924|SUPERIORITY||LS Mean Difference|-3.58|STANDARD_ERROR_OF_MEAN|1.16||0.0038|TWO_SIDED|95.0|-5.94|-1.23|||MMRM|||Week 28: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the Double-Blind baseline value.||-1.23|-5.94|0.0038
72461774|NCT02592434|144445924|SUPERIORITY||LS Mean Difference|-3.41|STANDARD_ERROR_OF_MEAN|1.01||0.002|TWO_SIDED|95.0|-5.47|-1.36|||MMRM|||Week 32: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the Double-Blind baseline value.||-1.36|-5.47|0.0020
72501702|NCT00609622|144533219|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.18||||0.2776|TWO_SIDED|95.0|-0.5|0.14|||t-test, 2 sided|||Differences in item 13 between treatment arms (C10 of D1) was analyzed from a two-sample t-test.||0.14|-0.50|0.2776
72501703|NCT00609622|144533219|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.27||||0.1403|TWO_SIDED|95.0|-0.62|0.09|||t-test, 2 sided|||Differences in item 13 between treatment arms (C13 of D1) was analyzed from a two-sample t-test.||0.09|-0.62|0.1403
72501704|NCT00609622|144533219|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.03||||0.9151|TWO_SIDED|95.0|-0.55|0.5|||t-test, 2 sided|||Differences in item 13 between treatment arms (C16 of D1) was analyzed from a two-sample t-test.||0.50|-0.55|0.9151
72501705|NCT00609622|144533219|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.34||||0.3277|TWO_SIDED|95.0|-0.36|1.05|||t-test, 2 sided|||Differences in item 13 between treatment arms (C19 of D1) was analyzed from a two-sample t-test.||1.05|-0.36|0.3277
72461775|NCT02592434|144445924|SUPERIORITY||LS Mean Difference|-5.66|STANDARD_ERROR_OF_MEAN|1.52||0.0007|TWO_SIDED|95.0|-8.74|-2.57|||MMRM|||Week 36: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the Double-Blind baseline value.||-2.57|-8.74|0.0007
72461776|NCT02592434|144445924|SUPERIORITY||LS Mean Difference|-5.62|STANDARD_ERROR_OF_MEAN|1.49||0.0007|TWO_SIDED|95.0|-8.66|-2.58|||MMRM|||Week 40: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the Double-Blind baseline value.||-2.58|-8.66|0.0007
72461777|NCT02592434|144445924|SUPERIORITY||LS Mean Difference|-4.41|STANDARD_ERROR_OF_MEAN|1.25||0.0018|TWO_SIDED|95.0|-6.99|-1.82|||MMRM|||Week 44:Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the Double-Blind baseline value.||-1.82|-6.99|0.0018
72461778|NCT02592434|144445926|SUPERIORITY||Difference in percentage|1.47||||0.861|TWO_SIDED|95.0|-14.96|17.9|||Normal approximation to the binomial|||Double Blind Baseline (Week 18)||17.90|-14.96|0.8610
72501706|NCT00609622|144533219|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0||||1|TWO_SIDED|95.0|-0.86|0.86|||t-test, 2 sided|||Differences in item 13 between treatment arms (C22 of D1) was analyzed from a two-sample t-test.||0.86|-0.86|1.0000
72461779|NCT02592434|144445926|SUPERIORITY||Difference in percentage|10.12||||0.2173|TWO_SIDED|95.0|-5.96|26.2|||Normal approximation to the binomial|||Week 20||26.20|-5.96|0.2173
72461780|NCT02592434|144445926|SUPERIORITY||Difference in percentage|12.94||||0.1135|TWO_SIDED|95.0|-3.08|28.96|||Normal approximation to the binomial|||Week 24||28.96|-3.08|0.1135
72461781|NCT02592434|144445926|SUPERIORITY||Difference in percentage|11.51||||0.161|TWO_SIDED|95.0|-4.58|27.6|||Normal approximation to the binomial|||Week 28||27.60|-4.58|0.1610
72461782|NCT02592434|144445926|SUPERIORITY||Difference in percentage|7.42||||0.3571|TWO_SIDED|95.0|-8.37|23.21|||Normal approximation to the binomial|||Week 32||23.21|-8.37|0.3571
72461783|NCT02592434|144445926|SUPERIORITY||Difference in percentage|14.44||||0.0716|TWO_SIDED|95.0|-1.27|30.16|||Normal approximation to the binomial|||Week 36||30.16|-1.27|0.0716
72501707|NCT00609622|144533219|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.57||||0.5661|TWO_SIDED|95.0|-1.53|2.67|||t-test, 2 sided|||Differences in item 13 between treatment arms (C25 of D1) was analyzed from a two-sample t-test.||2.67|-1.53|0.5661
72461784|NCT02592434|144445926|SUPERIORITY||Difference in percentage|14.4||||0.0746|TWO_SIDED|95.0|-1.43|30.24|||Normal approximation to the binomial|||Week 40||30.24|-1.43|0.0746
72501708|NCT00609622|144533219|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.4||||0.7309|TWO_SIDED|95.0|-2.95|2.15|||t-test, 2 sided|||Differences in item 13 between treatment arms (C28 of D1) was analyzed from a two-sample t-test.||2.15|-2.95|0.7309
72501709|NCT00609622|144533219|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.25||||0.3273|TWO_SIDED|95.0|-2.16|4.66|||t-test, 2 sided|||Differences in item 13 between treatment arms (C31 of D1) was analyzed from a two-sample t-test.||4.66|-2.16|0.3273
72461785|NCT02592434|144445926|SUPERIORITY||Difference in percentage|14.37||||0.0773|TWO_SIDED|95.0|-1.57|30.3|||Normal approximation to the binomial|||Week 44||30.30|-1.57|0.0773
72461786|NCT02592434|144445928|SUPERIORITY||Difference in percentage|-3.06||||0.5131|TWO_SIDED|95.0|-12.21|6.1|||Normal approximation to the binomial|||Double Blind Baseline (Week 18)||6.10|-12.21|0.5131
72461787|NCT02592434|144445928|SUPERIORITY||Difference in percentage|6.87||||0.0876|TWO_SIDED|95.0|-1.01|14.74|||Normal approximation to the binomial|||Week 20||14.74|-1.01|0.0876
72461788|NCT02592434|144445928|SUPERIORITY||Difference in percentage|6.79||||0.1561|TWO_SIDED|95.0|-2.59|16.16|||Normal approximation to the binomial|||Week 24||16.16|-2.59|0.1561
72461789|NCT02592434|144445928|SUPERIORITY||Difference in percentage|2.58||||0.5795|TWO_SIDED|95.0|-6.54|11.7|||Normal approximation to the binomial|||Week 28||11.70|-6.54|0.5795
72461790|NCT02592434|144445928|SUPERIORITY||Difference in percentage|5.4||||0.2435|TWO_SIDED|95.0|-3.67|14.47|||Normal approximation to the binomial|||Week 32||14.47|-3.67|0.2435
72461791|NCT02592434|144445928|SUPERIORITY||Difference in percentage|9.52||||0.0758|TWO_SIDED|95.0|-0.99|20.04|||Normal approximation to the binomial|||Week 36||20.04|-0.99|0.0758
72461792|NCT02592434|144445928|SUPERIORITY||Difference in percentage|10.91||||0.0464|TWO_SIDED|95.0|0.17|21.65|||Normal approximation to the binomial|||Week 40||21.65|0.17|0.0464
72501710|NCT00609622|144533219|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0|||<|0.0001|TWO_SIDED|95.0|0.0|0.0|||t-test, 2 sided|||Differences in item 13 between treatment arms (C34 of D1) was analyzed from a two-sample t-test.||0|0|<0.0001
72501711|NCT00609622|144533219|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.06||||0.7108|TWO_SIDED|95.0|-0.39|0.27|||t-test, 2 sided|||Differences in item 13 between treatment arms (EOT) was analyzed from a two-sample t-test.||0.27|-0.39|0.7108
72501712|NCT01696461|144533220|OTHER||||||||||||||||||Percentage of donors mobilized with plerixafor. No comparison group was analyzed.|||
72501713|NCT01696461|144533221|OTHER||||||||||||||||||This is a descriptive analysis. Percentage of donor experiencing toxicities was assessed at 30, 60, 120, and 240 minutes after administration of plerixafor on each day of collection and graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.0.3. Grade of maximum toxicity across all time points is reported.|||
72461793|NCT02592434|144445928|SUPERIORITY||Difference in percentage|8.06||||0.1634|TWO_SIDED|95.0|-3.27|19.38|||Normal approximation to the binomial|||Week 44||19.38|-3.27|0.1634
72501714|NCT01696461|144533222|OTHER||||||||||||||||||This is a descriptive analysis. The number of donors experiencing toxicities was assessed at 30, 60, 120, and 240 minutes after administration of plerixafor on each day of collection and one, six, and 12 months post-donation. Toxicities were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.0.3.|||
72501715|NCT01696461|144533223|OTHER||||||||||||||||||At 100 days after HCT, all patients in both the MAC and the RIC cohorts had achieved neutrophil engraftment. All patients in the MAC arm and 97% of patients in the RIC arm had achieved platelet engraftment. The median time to neutrophil engraftment was 13 and 15 days for MAC and RIC, respectively. The median time to platelet engraftment was 19 and 18 days for MAC and RIC, respectively.|||
72563599|NCT01098110|144658354|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-2.94|STANDARD_ERROR_OF_MEAN|0.56|<|0.0001|TWO_SIDED|95.0|-4.03|-1.84|||ANCOVA|Change from baseline a response variable, baseline score a covariate.|Asenapine 10 mg BID minus Placebo BID|||-1.84|-4.03|<0.0001
72461794|NCT02592434|144445929|SUPERIORITY||Difference in percentage|-17.42||||0.0062|TWO_SIDED|95.0|-29.88|-4.96|||Normal approximation to the binomial|||Double Blind baseline (Week 18)||-4.96|-29.88|0.0062
72461795|NCT02592434|144445929|SUPERIORITY||Difference in percentage|-0.44||||0.9427|TWO_SIDED|95.0|-12.34|11.47|||Normal approximation to the binomial|||Week 20||11.47|-12.34|0.9427
72461796|NCT02592434|144445929|SUPERIORITY||Difference in percentage|-0.6||||0.9308|TWO_SIDED|95.0|-14.03|12.84|||Normal approximation to the binomial|||Week 24||12.84|-14.03|0.9308
72461797|NCT02592434|144445929|SUPERIORITY||Difference in percentage|0.87||||0.8945|TWO_SIDED|95.0|-12.03|13.78|||Normal approximation to the binomial|||Week 28||13.78|-12.03|0.8945
72461798|NCT02592434|144445929|SUPERIORITY||Difference in percentage|2.22||||0.7455|TWO_SIDED|95.0|-11.2|15.64|||Normal approximation to the binomial|||Week 32||15.64|-11.20|0.7455
72461799|NCT02592434|144445929|SUPERIORITY||Difference in percentage|9.25||||0.1787|TWO_SIDED|95.0|-4.23|22.72|||Normal approximation to the binomial|||Week 36||22.72|-4.23|0.1787
72461800|NCT02592434|144445929|SUPERIORITY||Difference in percentage|12.1||||0.0695|TWO_SIDED|95.0|-0.97|25.17|||Normal approximation to the binomial|||Week 40||25.17|-0.97|0.0695
72461801|NCT02592434|144445929|SUPERIORITY||Difference in percentage|9.25||||0.1787|TWO_SIDED|95.0|-4.23|22.72|||Normal approximation to the binomial|||Week 44||22.72|-4.23|0.1787
72461802|NCT02592434|144445930|SUPERIORITY||Difference in percentage|-0.12||||0.9719|TWO_SIDED|95.0|-6.74|6.5|||Normal approximation to the binomial|||||6.50|-6.74|0.9719
72461803|NCT02592434|144445932|SUPERIORITY||LS Mean Difference|-0.87|STANDARD_ERROR_OF_MEAN|0.61||0.1595|TWO_SIDED|95.0|-2.08|0.35|||MMRM|||Week 20: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.||0.35|-2.08|0.1595
72461804|NCT02592434|144445932|SUPERIORITY||LS Mean difference|-1.42|STANDARD_ERROR_OF_MEAN|0.96||0.1421|TWO_SIDED|95.0|-3.32|0.48|||MMRM|||Week 24: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.||0.48|-3.32|0.1421
72461805|NCT02592434|144445932|SUPERIORITY||LS Mean difference|-1.66|STANDARD_ERROR_OF_MEAN|0.83||0.0552|TWO_SIDED|95.0|-3.37|0.04|||MMRM|||Week 28: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.||0.04|-3.37|0.0552
72461806|NCT02592434|144445932|SUPERIORITY||LS Mean difference|-1.17|STANDARD_ERROR_OF_MEAN|0.63||0.0822|TWO_SIDED|95.0|-2.5|0.17|||MMRM|||Week 32: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.||0.17|-2.50|0.0822
72461807|NCT02592434|144445932|SUPERIORITY||LS Mean difference|-3.98|STANDARD_ERROR_OF_MEAN|1.22||0.0041|TWO_SIDED|95.0|-6.53|-1.43|||MMRM|||Week 36: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.||-1.43|-6.53|0.0041
72461808|NCT02592434|144445932|SUPERIORITY||LS Mean difference|-3.57|STANDARD_ERROR_OF_MEAN|1.22||0.0085|TWO_SIDED|95.0|-6.12|-1.02|||MMRM|||Week 40: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.||-1.02|-6.12|0.0085
72461809|NCT02592434|144445932|SUPERIORITY||LS Mean difference|-2.24|STANDARD_ERROR_OF_MEAN|1.03||0.0384|TWO_SIDED|95.0|-4.36|-0.13|||MMRM|||Week 44: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.||-0.13|-4.36|0.0384
72501716|NCT01696461|144533224|OTHER||||||||||||||||||"Full donor myeloid chimerism was achieved relatively quickly in both RIC and MAC groups (median 100% at day +28 in both RIC and MAC), but conversion to full donor T-cell chimerism appeared to be slower in the RIC patients.~T-cell chimerism for MAC patients: median donor cell % (range):~Day +28: 92(59-100)%, Day +100: 97(76-100)%, Day +180: 100(91-100)%, Day +365: 100(100-100)%~T-cell chimerism for RIC patients: median donor cell % (range):~Day +28: 80(50-100)%, Day +100: 84(64-100)%, Day +180: 95(74-100)%, Day +365: 100(87-100)%"|||
72461810|NCT02592434|144445934|SUPERIORITY||LS Mean Difference|-0.26|STANDARD_ERROR_OF_MEAN|0.23||0.2595|TWO_SIDED|95.0|-0.72|0.19|||MMRM|||Week 20: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.||0.19|-0.72|0.2595
72461811|NCT02592434|144445934|SUPERIORITY||LS Mean difference|-0.69|STANDARD_ERROR_OF_MEAN|0.37||0.0674|TWO_SIDED|95.0|-1.42|0.05|||MMRM|||Week 24: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.||0.05|-1.42|0.0674
72461812|NCT02592434|144445934|SUPERIORITY||LS Mean difference|-0.95|STANDARD_ERROR_OF_MEAN|0.49||0.058|TWO_SIDED|95.0|-1.93|0.03|||MMRM|||Week 28: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.||0.03|-1.93|0.0580
72501717|NCT01696461|144533225|OTHER||||||||||||||||||This is a descriptive outcome.There were no cases of primary graft failure.|||
72501718|NCT01696461|144533226|OTHER|||||||||||||||||The cumulative incidence of acute graft-vs-host disease was examined in the RIC and MAC groups but was not directly compared with a statistical test.|The incidence of acute GVHD was quantified by computing the cumulative incidence probability and an appropriate 95% confidence interval. Death was treated as a competing risk.|||
72501719|NCT01696461|144533227|OTHER||||||||||||||||||Immune reconstitution was measured by CD3+CD4+ and CD3+CD8+ T cells in the peripheral blood of patients at days 28, 100, 180, and 365 after HCT. Notably, median CD3+CD4+ cell counts were \>200/µL at all times analyzed, including day 28 in both MAC and RIC groups.|||
72501720|NCT01696461|144533228|OTHER|||||||||||||||||Groups were not directly compared using a statistical test.|Percentage of recipients at-risk for CMV reactivation who experienced a reactivation.|||
72501721|NCT01696461|144533229|OTHER|||||||||||||||||The probability of treatment-related mortality and disease relapse/progression were examined in the RIC and MAC cohorts but were not directly compared between the two groups using a statistical test.|The incidence of treatment-related mortality and relapse was quantified by computing the cumulative incidence probability and an appropriate 95% confidence interval. When computing the cumulative incidence probability of treatment-related mortality and relapse, relapse and treatment-related mortality, respectively, were considered as a competing risk.|||
72501722|NCT01696461|144533230|OTHER|||||||||||||||||The probability of progression free survival and overall survival were examined in the RIC and MAC cohorts but were not directly compared between the two groups using a statistical test.|Kaplan-Meier curves were used to estimate the probability of progression-free survival and overall survival. Progression-free survival at 1 year was 53% (95% CI, 36% to 71%) after MAC and 64% (95% CI, 47% to 79%) after RIC. Overall survival at 1 year was 63% (95% CI, 46% to 79%) after MAC and 70% (95% CI, 53% to 84%) after RIC.|||
72501723|NCT01696461|144533231|OTHER|||||||||||||||||This outcome measure is descriptive.|This outcome measure is descriptive. The median cell dose and range are reported.|||
72501724|NCT01696461|144533232|OTHER|||||||||||||||||The cumulative incidence of chronic graft-vs-host disease was examined in the RIC and MAC groups but was not directly compared with a statistical test.|The incidence of chronic GVHD was quantified by computing the cumulative incidence probability and an appropriate 95% confidence interval. Death was treated as a competing event.|||
72501725|NCT01696461|144533233|OTHER||||||||||||||||||This is a descriptive analysis. There were no cases of secondary graft failure.|||
72501726|NCT01696461|144533234|OTHER||||||||||||||||||This outcome measure is descriptive. The median cell dose and range are reported.|||
72501727|NCT01245647|144533311|SUPERIORITY_OR_OTHER|||||||0.82|||||||t-test, 2 sided|||||||0.82
72501728|NCT01245647|144533312|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||||||1.0
72501729|NCT01245647|144533313|SUPERIORITY_OR_OTHER|||||||0.46|||||||Fisher Exact|||||||0.46
72461813|NCT02592434|144445934|SUPERIORITY||LS Mean difference|-0.79|STANDARD_ERROR_OF_MEAN|0.44||0.0751|TWO_SIDED|95.0|-1.67|0.08|||MMRM|||Week 32: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.||0.08|-1.67|0.0751
72461814|NCT02592434|144445934|SUPERIORITY||LS Mean difference|-1.01|STANDARD_ERROR_OF_MEAN|0.43||0.0251|TWO_SIDED|95.0|-1.88|-0.13|||MMRM|||Week 36: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.||-0.13|-1.88|0.0251
72621082|NCT02732145|144773174|SUPERIORITY|"Question: Is there a difference in the frequency of S-#-# result (non-specific lesions) of the Outer Vulvar Ring in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology?"||||||0.8618|||||||t-test proportion|||"Parameter: The difference in the frequency of S-#-# result (non-specific lesions) of the Outer Vulvar Ring in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology."||||0.8618
72621083|NCT02732145|144773174|SUPERIORITY|"Question: Is there a difference in the frequency of P-#-# result (specific lesions) of the Outer Vulvar Ring in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology?"||||||0.9786|||||||t-test proportion|||"Parameter: The difference in the frequency of P-#-# result (specific lesions) of the Outer Vulvar Ring in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology."||||0.9786
72621084|NCT02732145|144773174|SUPERIORITY|"Question: Is there a difference in the frequency of #-N-# result (no lesions) of the Middle Vulvar Ring in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology?"||||||1|||||||t-test proportion|||"Parameter: The difference in the frequency of #-N-# result (no lesions) of the Middle Vulvar Ring in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology."||||1.0000
72621085|NCT02732145|144773174|SUPERIORITY|"Question: Is there a difference in the frequency of #-S-# result (non-specific lesions) of the Middle Vulvar Ring in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology?"||||||0.8634|||||||t-test proportion|||"Parameter: The difference in the frequency of #-S-# result (non-specific lesions) of the Middle Vulvar Ring in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology."||||0.8634
72461815|NCT02592434|144445934|SUPERIORITY||LS Mean difference|-1.08|STANDARD_ERROR_OF_MEAN|0.49||0.0331|TWO_SIDED|95.0|-2.07|-0.09|||MMRM|||Week 40: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.||-0.09|-2.07|0.0331
72461816|NCT02592434|144445934|SUPERIORITY||LS Mean difference|-0.82|STANDARD_ERROR_OF_MEAN|0.42||0.0549|TWO_SIDED|95.0|-1.66|0.02|||MMRM|||Week 44: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.||0.02|-1.66|0.0549
72461817|NCT02592434|144445936|SUPERIORITY||LS mean difference|-0.54|STANDARD_ERROR_OF_MEAN|0.25||0.0353|TWO_SIDED|95.0|-1.04|-0.04|||MMRM|||Week 20: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.||-0.04|-1.04|0.0353
72461818|NCT02592434|144445936|SUPERIORITY||LS Mean difference|-0.84|STANDARD_ERROR_OF_MEAN|0.32||0.0094|TWO_SIDED|95.0|-1.47|-0.21|||MMRM|||Week 24: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.||-0.21|-1.47|0.0094
72461819|NCT02592434|144445936|SUPERIORITY||LS Mean difference|-0.8|STANDARD_ERROR_OF_MEAN|0.28||0.0065|TWO_SIDED|95.0|-1.36|-0.23|||MMRM|||Week 28: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.||-0.23|-1.36|0.0065
72461820|NCT02592434|144445936|SUPERIORITY||LS Mean difference|-0.89|STANDARD_ERROR_OF_MEAN|0.27||0.0018|TWO_SIDED|95.0|-1.43|-0.34|||MMRM|||Week 32: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.||-0.34|-1.43|0.0018
72461821|NCT02592434|144445936|SUPERIORITY||LS Mean difference|-1.42|STANDARD_ERROR_OF_MEAN|0.41||0.001|TWO_SIDED|95.0|-2.24|-0.61|||MMRM|||Week 36: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.||-0.61|-2.24|0.0010
72501730|NCT01245647|144533314|SUPERIORITY_OR_OTHER|||||||0.12||||||no significant difference by Fisher exact test|Fisher Exact|||||||0.12
72501731|NCT01245647|144533315|SUPERIORITY_OR_OTHER|||||||0.67|||||||t-test, 2 sided|||||||0.67
72461822|NCT02592434|144445936|SUPERIORITY||LS Mean difference|-1.61|STANDARD_ERROR_OF_MEAN|0.4||0.0002|TWO_SIDED|95.0|-2.42|-0.81|||MMRM|||Week 40: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.||-0.81|-2.42|0.0002
72461823|NCT02592434|144445936|SUPERIORITY||LS Mean difference|-1.58|STANDARD_ERROR_OF_MEAN|0.43||0.0007|TWO_SIDED|95.0|-2.44|-0.71|||MMRM|||Week 44: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.||-0.71|-2.44|0.0007
72501732|NCT04321343|144533341|SUPERIORITY||Mean Difference (Final Values)|-25.313|STANDARD_ERROR_OF_MEAN|9.587||0.0083|TWO_SIDED|95.0|-44.1036|-6.5227|||ANCOVA|ANCOVA model using a multiple imputation procedure based on the fully conditional specification method.|Mean difference (final values) is the difference in Least Squares (LS) Means estimated in the ANCOVA model.|||-6.5227|-44.1036|0.0083
72501733|NCT04321343|144533341|SUPERIORITY||Mean Difference (Final Values)|-21.003|STANDARD_ERROR_OF_MEAN|9.287||0.0237|TWO_SIDED|95.0|-39.2074|-2.7991|||ANCOVA|ANCOVA model using a multiple imputation procedure based on the fully conditional specification method.|Mean difference (final values) is the difference in Least Squares (LS) Means estimated in the ANCOVA model.|||-2.7991|-39.2074|0.0237
72501734|NCT04321343|144533341|SUPERIORITY||Mean Difference (Final Values)|-23.748|STANDARD_ERROR_OF_MEAN|9.053||0.0087|TWO_SIDED|95.0|-41.4923|-6.0035|||ANCOVA|ANCOVA model using a multiple imputation procedure based on the fully conditional specification method.|Mean difference (final values) is the difference in Least Squares (LS) Means estimated in the ANCOVA model.|||-6.0035|-41.4923|0.0087
72501735|NCT04321343|144533342|SUPERIORITY||Hodges-Lehmann midpoint estimate|-26.226|STANDARD_ERROR_OF_MEAN|10.252||0.0105|TWO_SIDED|95.0|-46.3208|-6.1313|||Wilcoxon (Mann-Whitney)|Non-parametric pairwaise Wilcoxon tests using a multiple imputation procedure based on the fully conditional specification method.||||-6.1313|-46.3208|0.0105
72621086|NCT02732145|144773174|SUPERIORITY|"Question: Is there a difference in the frequency of #-P-# result (specific lesions) of the Middle Vulvar Ring in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology?"||||||0.7992|||||||t-test proportion|||"Parameter: The difference in the frequency of #-P-# result (specific lesions) of the Middle Vulvar Ring in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology."||||0.7992
72461824|NCT02592434|144445938|SUPERIORITY||LS Mean Difference|-0.42|STANDARD_ERROR_OF_MEAN|0.2||0.0398|TWO_SIDED|95.0|-0.83|-0.02|||MMRM|||Week 20: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.||-0.02|-0.83|0.0398
72621087|NCT02732145|144773174|SUPERIORITY|"Question: Is there a difference in the frequency of #-#-N result (no lesions) of the Inner Vulvar Ring in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology?"||||||0.3912|||||||t-test proportion|||"Parameter: The difference in the frequency of #-#-N result (no lesions) of the Inner Vulvar Ring in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology."||||0.3912
72461825|NCT02592434|144445938|SUPERIORITY||LS Mean difference|-0.94|STANDARD_ERROR_OF_MEAN|0.28||0.0011|TWO_SIDED|95.0|-1.49|-0.39|||MMRM|||Week 24: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.||-0.39|-1.49|0.0011
72461826|NCT02592434|144445938|SUPERIORITY||LS mean difference|-0.82|STANDARD_ERROR_OF_MEAN|0.32||0.0131|TWO_SIDED|95.0|-1.47|-0.18|||MMRM|||Week 28: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.||-0.18|-1.47|0.0131
72461827|NCT02592434|144445938|SUPERIORITY||LS mean difference|-0.97|STANDARD_ERROR_OF_MEAN|0.32||0.0039|TWO_SIDED|95.0|-1.62|-0.33|||MMRM|||Week 32: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.||-0.33|-1.62|0.0039
72461828|NCT02592434|144445938|SUPERIORITY||LS mean difference|-0.53|STANDARD_ERROR_OF_MEAN|0.29||0.0711|TWO_SIDED|95.0|-1.1|0.05|||MMRM|||Week 36: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.||0.05|-1.10|0.0711
72461829|NCT02592434|144445938|SUPERIORITY||LS mean difference|-0.63|STANDARD_ERROR_OF_MEAN|0.34||0.0658|TWO_SIDED|95.0|-1.3|0.04|||MMRM|||Week 40: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.||0.04|-1.30|0.0658
72461830|NCT02592434|144445938|SUPERIORITY||LS mean difference|-0.73|STANDARD_ERROR_OF_MEAN|0.29||0.0154|TWO_SIDED|95.0|-1.31|-0.15|||MMRM|||Week 44: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.||-0.15|-1.31|0.0154
72461831|NCT02592434|144445940|SUPERIORITY||LS Mean Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.04||0.4777|TWO_SIDED|95.0|-0.12|0.06|||MMRM|||Week 20: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.||0.06|-0.12|0.4777
72461832|NCT02592434|144445940|SUPERIORITY||LS mean difference|-0.07|STANDARD_ERROR_OF_MEAN|0.04||0.0779|TWO_SIDED|95.0|-0.16|0.01|||MMRM|||Week 24: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.||0.01|-0.16|0.0779
72461833|NCT02592434|144445940|SUPERIORITY||LS mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.05||0.0324|TWO_SIDED|95.0|-0.19|-0.01|||MMRM|||Week 28: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.||-0.01|-0.19|0.0324
72621088|NCT02732145|144773174|SUPERIORITY|"Question: Is there a difference in the frequency of #-#-S result (non-specific lesions) of the Inner Vulvar Ring in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology?"||||||0.6152|||||||t-test proportion|||"Parameter: The difference in the frequency of #-#-S result (non-specific lesions) of the Inner Vulvar Ring in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology."||||0.6152
72461834|NCT02592434|144445940|SUPERIORITY||LS mean difference|-0.09|STANDARD_ERROR_OF_MEAN|0.06||0.1061|TWO_SIDED|95.0|-0.2|0.02|||MMRM|||Week 32: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.||0.02|-0.20|0.1061
72461835|NCT02592434|144445940|SUPERIORITY||LS mean difference|-0.12|STANDARD_ERROR_OF_MEAN|0.06||0.0572|TWO_SIDED|95.0|-0.24|0.0|||MMRM|||Week 36: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.||0.00|-0.24|0.0572
72501736|NCT04321343|144533342|SUPERIORITY||Hodges-Lehmann midpoint estimate|-21.496|STANDARD_ERROR_OF_MEAN|9.873||0.0295|TWO_SIDED|95.0|-40.8475|-2.1451|||Wilcoxon (Mann-Whitney)|Non-parametric pairwaise Wilcoxon tests using a multiple imputation procedure based on the fully conditional specification method.||||-2.1451|-40.8475|0.0295
72461836|NCT02592434|144445940|SUPERIORITY||LS mean difference|-0.11|STANDARD_ERROR_OF_MEAN|0.06||0.0689|TWO_SIDED|95.0|-0.24|0.01|||MMRM|||Week 40: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.||0.01|-0.24|0.0689
72461837|NCT02592434|144445940|SUPERIORITY||LS mean difference|-0.12|STANDARD_ERROR_OF_MEAN|0.05||0.0292|TWO_SIDED|95.0|-0.22|-0.01|||MMRM|||Week 44: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.||-0.01|-0.22|0.0292
72461838|NCT02592434|144445942|SUPERIORITY||LS Mean Difference|3.79|STANDARD_ERROR_OF_MEAN|3.77||0.3179|TWO_SIDED|95.0|-3.72|11.31|||MMRM|||Global Health: Analysis based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the Double-Blind baseline value.||11.31|-3.72|0.3179
72501737|NCT04321343|144533342|SUPERIORITY||Hodges-Lehmann midpoint estimate|-24.29|STANDARD_ERROR_OF_MEAN|9.746||0.0127|TWO_SIDED|95.0|-43.392|-5.1884|||Wilcoxon (Mann-Whitney)|Non-parametric pairwaise Wilcoxon tests using a multiple imputation procedure based on the fully conditional specification method.||||-5.1884|-43.3920|0.0127
72392921|NCT00518986|144293381|SUPERIORITY_OR_OTHER|||||||0.0679|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0679
72501738|NCT04321343|144533343|SUPERIORITY||Mean Difference (Final Values)|-4.671|STANDARD_ERROR_OF_MEAN|1.824||0.0105|TWO_SIDED|95.0|-8.2463|-1.0957|||ANCOVA|ANCOVA model using a multiple imputation procedure based on the fully conditional specification method.|Mean difference (final values) is the difference in Least Squares (LS) Means estimated in the ANCOVA model.|||-1.0957|-8.2463|0.0105
72392922|NCT00518986|144293382|SUPERIORITY_OR_OTHER|||||||0.0153|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0153
72392923|NCT00518986|144293383|SUPERIORITY_OR_OTHER|||||||0.0296|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0296
72461839|NCT02592434|144445942|SUPERIORITY||LS mean difference|3.28|STANDARD_ERROR_OF_MEAN|4.27||0.4452|TWO_SIDED|95.0|-5.23|11.78|||MMRM|||Physical Functioning: Analysis based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the Double-Blind baseline value.||11.78|-5.23|0.4452
72461840|NCT02592434|144445942|SUPERIORITY||LS mean difference|5.47|STANDARD_ERROR_OF_MEAN|4.76||0.2539|TWO_SIDED|95.0|-4.01|14.95|||MMRM|||Social Limitations: Emotional: Analysis based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the Double-Blind baseline value.||14.95|-4.01|0.2539
72461841|NCT02592434|144445942|SUPERIORITY||LS mean difference|7.22|STANDARD_ERROR_OF_MEAN|5.56||0.1981|TWO_SIDED|95.0|-3.86|18.3|||MMRM|||Social Limitations: Physical Subscale: Analysis based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the Double-Blind baseline value.||18.30|-3.86|0.1981
72461842|NCT02592434|144445942|SUPERIORITY||LS mean difference|8.26|STANDARD_ERROR_OF_MEAN|4.36||0.062|TWO_SIDED|95.0|-0.43|16.94|||MMRM|||Bodily Pain: Analysis based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the Double-Blind baseline value.||16.94|-0.43|0.0620
72461843|NCT02592434|144445942|SUPERIORITY||LS mean difference|-3.43|STANDARD_ERROR_OF_MEAN|2.83||0.2291|TWO_SIDED|95.0|-9.06|2.2|||MMRM|||Behavior: Analysis based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the Double-Blind baseline value.||2.20|-9.06|0.2291
72461844|NCT02592434|144445942|SUPERIORITY||LS mean difference|-3.65|STANDARD_ERROR_OF_MEAN|3.9||0.353|TWO_SIDED|95.0|-11.43|4.13|||MMRM|||Global Behavior: Analysis based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the Double-Blind baseline value.||4.13|-11.43|0.3530
72461845|NCT02592434|144445942|SUPERIORITY||LS mean difference|-3.47|STANDARD_ERROR_OF_MEAN|3.41||0.3114|TWO_SIDED|95.0|-10.26|3.32|||MMRM|||Mental Health: Analysis based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the Double-Blind baseline value.||3.32|-10.26|0.3114
72501739|NCT04321343|144533343|SUPERIORITY||Mean Difference (Final Values)|-4.097|STANDARD_ERROR_OF_MEAN|1.743||0.0188|TWO_SIDED|95.0|-7.514|-0.6799|||ANCOVA|ANCOVA model using a multiple imputation procedure based on the fully conditional specification method.|Mean difference (final values) is the difference in Least Squares (LS) Means estimated in the ANCOVA model.|||-0.6799|-7.5140|0.0188
72501740|NCT04321343|144533343|SUPERIORITY||Mean Difference (Final Values)|-4.321|STANDARD_ERROR_OF_MEAN|1.689||0.0105|TWO_SIDED|95.0|-7.6307|-1.0104|||ANCOVA|ANCOVA model using a multiple imputation procedure based on the fully conditional specification method.|Mean difference (final values) is the difference in Least Squares (LS) Means estimated in the ANCOVA model.|||-1.0104|-7.6307|0.0105
72501741|NCT04321343|144533344|SUPERIORITY||Odds Ratio (OR)|2.61||||0.1634|TWO_SIDED|95.0|0.677|10.087|||Cochran-Mantel-Haenszel|CMH with multiple imputation||||10.087|0.677|0.1634
72501742|NCT04321343|144533344|SUPERIORITY||Odds Ratio (OR)|3.26||||0.0722|TWO_SIDED|95.0|0.899|11.831|||Cochran-Mantel-Haenszel|CMH with multiple imputation||||11.831|0.899|0.0722
72392924|NCT00518986|144293384|SUPERIORITY_OR_OTHER|||||||0.0107|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0107
72392925|NCT00518986|144293385|SUPERIORITY_OR_OTHER|||||||0.01||95.0||||P-value for the treatment comparison is from a Pearson's chi-square test|Chi-squared|||Responders are defined as patients with a total score on FOSQ \> 17.9||||0.0100
72392926|NCT00518986|144293386|SUPERIORITY_OR_OTHER|||||||0.0854||95.0||||P-value for treatment comparison is from a Pearson's chi-square test|Chi-squared|||Responders are defined as subjects with a total score of \> 17.9||||0.0854
72461846|NCT02592434|144445942|SUPERIORITY||LS mean difference|0.71|STANDARD_ERROR_OF_MEAN|4.46||0.8736|TWO_SIDED|95.0|-8.18|9.61|||MMRM|||Self Esteem: Analysis based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the Double-Blind baseline value.||9.61|-8.18|0.8736
72501743|NCT04321343|144533344|SUPERIORITY||Odds Ratio (OR)|3.17||||0.0703|TWO_SIDED|95.0|0.909|11.052|||Cochran-Mantel-Haenszel|CMH with multiple imputation||||11.052|0.909|0.0703
72501744|NCT04321343|144533345|SUPERIORITY||Mean Difference (Final Values)|-6.5|STANDARD_ERROR_OF_MEAN|8.2||0.4318|TWO_SIDED|95.0|-22.66|9.72|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||9.72|-22.66|0.4318
72501745|NCT04321343|144533345|SUPERIORITY||Mean Difference (Final Values)|-1.6|STANDARD_ERROR_OF_MEAN|8.0||0.8382|TWO_SIDED|95.0|-17.37|14.1|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||14.10|-17.37|0.8382
72501746|NCT04321343|144533345|SUPERIORITY||Mean Difference (Final Values)|5.2|STANDARD_ERROR_OF_MEAN|7.7||0.4982|TWO_SIDED|95.0|-9.92|20.33|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||20.33|-9.92|0.4982
72392927|NCT00518986|144293387|SUPERIORITY_OR_OTHER|||||||0.0027||95.0||||P-value for the treatment comparison is from Pearson's chi-square test|Chi-squared|||Responders are defined as subjects with a total score \> 17.9||||0.0027
72392928|NCT00518986|144293388|SUPERIORITY_OR_OTHER|||||||0.0189||95.0||||P-value for the treatment comparison is from a Pearson's chi-square test.|Chi-squared|||Responders are defined as subjects who had a total score of \> 17.9||||0.0189
72392929|NCT00518986|144293389|SUPERIORITY_OR_OTHER|||||||0.024||95.0||||P-value for the treatment comparison is from a Pearson's chi-square test|Chi-squared|||Responders are defined as subjects with total score \> 17.9||||0.0240
72461847|NCT02592434|144445942|SUPERIORITY||LS mean difference|1.77|STANDARD_ERROR_OF_MEAN|2.48||0.4778|TWO_SIDED|95.0|-3.18|6.72|||MMRM|||General Health Subscale: Analysis based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the Double-Blind baseline value.||6.72|-3.18|0.4778
72461848|NCT02592434|144445942|SUPERIORITY||LS mean difference|-0.02|STANDARD_ERROR_OF_MEAN|0.13||0.8909|TWO_SIDED|95.0|-0.28|0.25|||MMRM|||Change in Health: Analysis based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the Double-Blind baseline value.||0.25|-0.28|0.8909
72461849|NCT02592434|144445942|SUPERIORITY||LS mean difference|8.97|STANDARD_ERROR_OF_MEAN|5.81||0.127|TWO_SIDED|95.0|-2.61|20.55|||MMRM|||Emotional Impact on Parent: Analysis based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the Double-Blind baseline value.||20.55|-2.61|0.1270
72461850|NCT02592434|144445942|SUPERIORITY||LS mean difference|-6.72|STANDARD_ERROR_OF_MEAN|3.96||0.0944|TWO_SIDED|95.0|-14.62|1.18|||MMRM|||Time Impact on Parent: Analysis based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the Double-Blind baseline value.||1.18|-14.62|0.0944
72461851|NCT02592434|144445942|SUPERIORITY||LS mean difference|-8.6|STANDARD_ERROR_OF_MEAN|3.23||0.0095|TWO_SIDED|95.0|-15.03|-2.17|||MMRM|||Family Activities: Analysis based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the Double-Blind baseline value.||-2.17|-15.03|0.0095
72461852|NCT02592434|144445942|SUPERIORITY||LS mean difference|2.59|STANDARD_ERROR_OF_MEAN|4.29||0.5474|TWO_SIDED|95.0|-5.96|11.14|||MMRM|||Family Cohesion: Analysis based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the Double-Blind baseline value.||11.14|-5.96|0.5474
72461853|NCT02592434|144445942|SUPERIORITY||LS mean difference|3.48|STANDARD_ERROR_OF_MEAN|2.03||0.0902|TWO_SIDED|95.0|-0.56|7.52|||MMRM|||Physical Health Summary: Analysis based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the Double-Blind baseline value.||7.52|-0.56|0.0902
72461854|NCT02592434|144445942|SUPERIORITY||LS mean difference|-0.75|STANDARD_ERROR_OF_MEAN|1.67||0.6539|TWO_SIDED|95.0|-4.07|2.57|||MMRM|||Psychosocial Health Summary : Analysis based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the Double-Blind baseline value.||2.57|-4.07|0.6539
72501747|NCT04321343|144533346|SUPERIORITY||Odds Ratio (OR)|0.72||||0.7137|TWO_SIDED|95.0|0.131|3.935|||Cochran-Mantel-Haenszel|||||3.935|0.131|0.7137
72461855|NCT02592434|144445944|SUPERIORITY||LS Mean Difference|-0.32|STANDARD_ERROR_OF_MEAN|0.24||0.1894|TWO_SIDED|95.0|-0.8|0.16|||MMRM|||Week 20: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.||0.16|-0.80|0.1894
72501748|NCT04321343|144533346|SUPERIORITY||Odds Ratio (OR)|3.7||||0.0597|TWO_SIDED|95.0|0.937|14.58|||Cochran-Mantel-Haenszel|||||14.580|0.937|0.0597
72501749|NCT04321343|144533346|SUPERIORITY||Odds Ratio (OR)|2.61||||0.1749|TWO_SIDED|95.0|0.655|10.43|||Cochran-Mantel-Haenszel|||||10.430|0.655|0.1749
72501750|NCT04321343|144533347|SUPERIORITY||Mean Difference (Final Values)|-2.9|STANDARD_ERROR_OF_MEAN|8.8||0.7449|TWO_SIDED|95.0|-20.15|14.43|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||14.43|-20.15|0.7449
72501751|NCT04321343|144533347|SUPERIORITY||Mean Difference (Final Values)|-3.0|STANDARD_ERROR_OF_MEAN|8.6||0.7255|TWO_SIDED|95.0|-19.93|13.9|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||13.90|-19.93|0.7255
72392930|NCT00518986|144293390|SUPERIORITY_OR_OTHER|||||||0.332||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.3320
72392931|NCT00518986|144293391|SUPERIORITY_OR_OTHER|||||||0.893||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.8930
72392932|NCT00518986|144293392|SUPERIORITY_OR_OTHER|||||||0.1774||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.1774
72461856|NCT02592434|144445944|SUPERIORITY||LS mean difference|-0.95|STANDARD_ERROR_OF_MEAN|0.31||0.0026|TWO_SIDED|95.0|-1.56|-0.34|||MMRM|||Week 24: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.||-0.34|-1.56|0.0026
72461857|NCT02592434|144445944|SUPERIORITY||LS mean difference|-0.87|STANDARD_ERROR_OF_MEAN|0.31||0.0067|TWO_SIDED|95.0|-1.5|-0.25|||MMRM|||Week 28: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.||-0.25|-1.50|0.0067
72501752|NCT04321343|144533347|SUPERIORITY||Mean Difference (Final Values)|2.4|STANDARD_ERROR_OF_MEAN|8.2||0.7755|TWO_SIDED|95.0|-13.89|18.59|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||18.59|-13.89|0.7755
72501753|NCT04321343|144533348|SUPERIORITY||Odds Ratio (OR)|3.12||||0.1325|TWO_SIDED|95.0|0.703|13.806|||Cochran-Mantel-Haenszel|||||13.806|0.703|0.1325
72501754|NCT04321343|144533348|SUPERIORITY||Odds Ratio (OR)|0.99||||0.9918|TWO_SIDED|95.0|0.201|4.898|||Cochran-Mantel-Haenszel|||||4.898|0.201|0.9918
72501755|NCT04321343|144533348|SUPERIORITY||Odds Ratio (OR)|4.78||||0.041|TWO_SIDED|95.0|1.053|21.714|||Cochran-Mantel-Haenszel|||||21.714|1.053|0.0410
72621089|NCT02732145|144773174|SUPERIORITY|"Question: Is there a difference in the frequency of #-#-P result (specific lesions) of the Inner Vulvar Ring in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology?"||||||0.6108|||||||t-test proportion|||"Parameter: The difference in the frequency of #-#-P result (specific lesions) of the Inner Vulvar Ring in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology."||||0.6108
72461858|NCT02592434|144445944|SUPERIORITY||LS mean difference|-0.99|STANDARD_ERROR_OF_MEAN|0.37||0.0091|TWO_SIDED|95.0|-1.73|-0.25|||MMRM|||Week 32: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.||-0.25|-1.73|0.0091
72621090|NCT02732145|144773174|SUPERIORITY|"Question: Is there a difference in the frequency of N-N-N result (no lesions) in any of the Three Vulvar Rings in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology?"||||||1|||||||t-test proportion|||"Parameter: The difference in the frequency of N-N-N result (no lesions) in any of the Three Vulvar Rings in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology."||||1.0000
72461859|NCT02592434|144445944|SUPERIORITY||LS mean difference|-0.53|STANDARD_ERROR_OF_MEAN|0.28||0.0632|TWO_SIDED|95.0|-1.09|0.03|||MMRM|||Week 36: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.||0.03|-1.09|0.0632
72461860|NCT02592434|144445944|SUPERIORITY||LS mean difference|-0.71|STANDARD_ERROR_OF_MEAN|0.32||0.0306|TWO_SIDED|95.0|-1.35|-0.07|||MMRM|||Week 40: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.||-0.07|-1.35|0.0306
72461861|NCT02592434|144445944|SUPERIORITY||LS mean difference|-0.8|STANDARD_ERROR_OF_MEAN|0.31||0.0118|TWO_SIDED|95.0|-1.41|-0.18|||MMRM|||Week 44: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.||-0.18|-1.41|0.0118
72461862|NCT03082196|144445980|SUPERIORITY||Mean Difference (Final Values)|-1.0||||0.037|TWO_SIDED|95.0|-1.9|-0.1|||t-test, 2 sided||The direction of the comparison (difference) is the test varnish to the standard varnish. A negative value for the difference indicates a lower caries increment in the test varnish as compared to the standard varnish.|||-0.1|-1.9|0.037
72461863|NCT03082196|144445981|SUPERIORITY||Mean Difference (Final Values)|-0.7||||0.062|TWO_SIDED|95.0|-1.5|0.1|||t-test, 2 sided||The direction of the comparison (difference) is the test varnish to the standard varnish. A negative value for the difference indicates a lower caries increment in the test varnish as compared to the standard varnish.|||0.1|-1.5|0.062
72461864|NCT03082196|144445982|SUPERIORITY||Mean Difference (Final Values)|-0.3||||0.11|TWO_SIDED|95.0|-0.5|0.1|||t-test, 2 sided||"The direction of the comparison (difference) is the test varnish to the standard varnish. A negative value for the difference indicates a happier response in the test varnish as compared to the standard varnish."|||0.1|-0.5|0.11
72461865|NCT03082196|144445983|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.74|TWO_SIDED|95.0|-0.2|0.3|||t-test, 2 sided||"The direction of the comparison (difference) is the test varnish to the standard varnish. A positive value for the difference indicates an unhappier response in the test varnish as compared to the standard varnish."|||0.3|-0.2|0.74
72461866|NCT01695993|144445985|OTHER|Primary Analysis: The Primary Aim to determine whether acupressure bands provided with efficacy-enhancing supplementary material are more effective in controlling chemotherapy-induced nausea than acupressure bands provided with neutral supplementary material was examined using ANCOVA with Peak Nausea after the first chemotherapy as the response, Arm (Arms 2 and 3) as the factor and expectancy of acupressure bands as the covariate.|Mean Difference (Net)|0.03|STANDARD_DEVIATION|1.9||0.05|TWO_SIDED|||||Not adjusted|ANCOVA|||||||.05
72461867|NCT01072396|144446028|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.06||||0.0087||95.0|0.02|0.11||Based on mixed effect model with repeated measures (MMRM) with fixed categorical effects for treatment, period and random effect for patient. Period baseline and patient baseline (average of two period baselines) were covariates in the model.|Mixed Models Analysis|Restricted maximum likelihood (REML) based MMRM||Placebo versus Tiotropium - crossover design||0.11|0.02|0.0087
72461868|NCT01072396|144446029|SUPERIORITY_OR_OTHER||Adjusted mean ratio|1.0685||||0.067||95.0|0.9953|1.147||Based on mixed effect model with repeated measures (MMRM) with fixed categorical effects for treatment, period and random effect for patient. Period baseline and patient baseline (average of two period baselines) were covariates in the model.|Mixed Models Analysis|Restricted maximum likelihood (REML) based MMRM||Placebo versus Tiotropium - corssover design||1.1470|0.9953|0.0670
72461869|NCT01072396|144446030|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2059||||0.2417||95.0|-0.5527|0.1408||Based on mixed effect model with repeated measures (MMRM) with fixed categorical effects for treatment, period and random effect for patient. Period baseline and patient baseline (average of two period baselines) were covariates in the model.|Mixed Models Analysis|Restricted maximum likelihood (REML) based MMRM||Placebo versus Tiotropium - corssover design||0.1408|-0.5527|0.2417
72461870|NCT01106586|144446031|NON_INFERIORITY_OR_EQUIVALENCE|A total of 700 HIV-1 infected participants, randomized in a 1:1 ratio to 2 groups would achieve at least 95% power to establish noninferiority in Week 48 response (HIV-1 RNA \< 50 copies/mL per the FDA-defined snapshot analysis) rate difference between the 2 groups. For sample size and power computation, it was assumed that both treatment groups have a response rate of 0.795, a noninferiority margin of 0.12, and that the significance level of the test is at a one-sided, 0.025 level.|Difference in response rates|3.0|||||TWO_SIDED|95.2|-1.9|7.8|||||To preserve the overall alpha level: 0.05, accounting for 2 interim analyses for Independent Data Monitoring Committee meetings, the 95.2% CI was computed using normal approximation stratified by baseline HIV-1 RNA (≤ 100,000 or \> 100,000 copies/mL).|The null hypothesis was that the Stribild group is at least 12% worse than the ATV/r + Truvada group with respect to percentage of participants achieving HIV-1 RNA \< 50 copies/mL (response rate as defined by the snapshot analysis algorithm) at Week 48; the alternative hypothesis was that the response rate in the Stribild group is less than 12% worse than that in the ATV/r + Truvada Group.||7.8|-1.9|
72461871|NCT00938041|144446045|SUPERIORITY_OR_OTHER||percentage of participants|25.0|||||TWO_SIDED|95.0|10.0|40.0|||||The estimated value reflects the percentage of participants with complete response. Percentages are calculated using the number of participants in the ITT-Exposed Population as the denominator.|||40|10|
72461872|NCT00938041|144446045|SUPERIORITY_OR_OTHER||percentage of participants|25.0|||||TWO_SIDED|95.0|10.0|40.0|||||The estimated value reflects the percentage of participants with confirmed complete response. Percentages are calculated using the number of participants in the ITT-Exposed Population as the denominator.|||40|10|
72461873|NCT00404547|144446085|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||This is an analysis of the change in Asthma Control Questionnaire (ACQ) after 12 weeks of treatment.||||<0.0001
72461874|NCT02332824|144446126|SUPERIORITY_OR_OTHER||LS Mean difference|-0.325|||<|0.0001|TWO_SIDED|95.0|-0.4845|-0.1649||In the primary analysis, each TAK-272 group will be compared with placebo group based on a step-down testing procedure, which will be employed for multiple comparison adjustment.|ANCOVA||Estimated Value was for LS mean differences (TAK-272 5 mg-placebo) in log-transformed UACR changes from baseline to the end of treatment period.|||-0.1649|-0.4845|<0.0001
72461875|NCT02332824|144446126|SUPERIORITY_OR_OTHER||LS Mean difference|-0.469|||<|0.0001|TWO_SIDED|95.0|-0.6251|-0.3132||In the primary analysis, each TAK-272 group will be compared with placebo group based on a step-down testing procedure, which will be employed for multiple comparison adjustment.|ANCOVA||Estimated Value was for LS mean differences (TAK-272 20 mg-placebo) in log-transformed UACR changes from baseline to the end of treatment period.|||-0.3132|-0.6251|<0.0001
72461876|NCT02332824|144446126|SUPERIORITY_OR_OTHER||LS Mean difference|-0.63|||<|0.0001|TWO_SIDED|95.0|-0.7897|-0.4711||In the primary analysis, each TAK-272 group will be compared with placebo group based on a step-down testing procedure, which will be employed for multiple comparison adjustment.|ANCOVA||Estimated Value was for LS mean differences (TAK-272 40 mg -placebo) in log-transformed UACR changes from baseline to the end of treatment period.|||-0.4711|-0.7897|<0.0001
72461877|NCT02332824|144446126|SUPERIORITY_OR_OTHER||LS Mean difference|-0.65|||<|0.0001|TWO_SIDED|95.0|-0.8083|-0.4908||In the primary analysis, each TAK-272 group will be compared with placebo group based on a step-down testing procedure, which will be employed for multiple comparison adjustment.|ANCOVA||Estimated Value was for LS mean differences (TAK-272 80 mg -placebo) in log-transformed UACR changes from baseline to the end of treatment period.|||-0.4908|-0.8083|<0.0001
72461878|NCT02332824|144446126|SUPERIORITY_OR_OTHER||LS Mean difference|-0.53|||<|0.0001|TWO_SIDED|95.0|-0.6874|-0.3719||In the primary analysis, each TAK-272 group will be compared with placebo group based on a step-down testing procedure, which will be employed for multiple comparison adjustment.|ANCOVA||Estimated Value was for LS mean differences (Candesartan cilexetil 8 mg -placebo group) in log-transformed UACR changes from baseline to the end of treatment period.|||-0.3719|-0.6874|<0.0001
72461879|NCT00914732|144446131|NON_INFERIORITY|The mean difference in log2 transformed peak titers between IMVAMUNE® (1x10\^8 TCID50) liquid formulation (Liquid SC Group) and IMVAMUNE® (1x10\^8 TCID50) lyophilized formulation (Lyophilized SC) with its associated two-sided 97.5% confidence interval (CI) was computed. If the upper limit of the 97.5% CI was less than 1, then the Lyophilized SC was considered non-inferior to the Liquid SC group. The difference and the CI are reported on the log2 scale.|Mean Difference (Final Values)|-0.74|||||TWO_SIDED|97.5|-1.23|-0.25||||||The sample size calculations targeted at least 80% power to test non-inferiority for the primary and secondary immunogenicity end points for two investigational arms in reference to a control arm. Assuming a standard deviation of 2.8 for log2 peak PRNT or ELISA titer in each group, a non-inferiority margin of 2.0-fold, a type I error rate of 1.25% (Bonferroni adjusted for 2 comparisons), and drop-out rate of 10%, 165 participants in each group were to be enrolled to achieve 148 evaluable||-0.25|-1.23|
72461880|NCT00914732|144446132|NON_INFERIORITY|The mean difference in log2 transformed peak titers between IMVAMUNE® (1x10\^8 TCID50) liquid formulation (Liquid SC Group) and IMVAMUNE® (1x10\^8 TCID50) lyophilized formulation (Lyophilized SC) with its associated two-sided 97.5% confidence interval (CI) was computed. If the upper limit of the 97.5% CI was less than 1, then the Lyophilized SC was considered non-inferior to the Liquid SC group. The difference and the CI are reported on the log2 scale.|Mean Difference (Final Values)|-0.83|||||TWO_SIDED|97.5|-1.32|-0.33||||||The sample size calculations targeted at least 80% power to test non-inferiority for the primary and secondary immunogenicity end points for two investigational arms in reference to a control arm. Assuming a standard deviation of 2.8 for log2 peak PRNT or ELISA titer in each group, a non-inferiority margin of 2.0-fold, a type I error rate of 1.25% (Bonferroni adjusted for 2 comparisons), and drop-out rate of 10%, 165 participants in each group were to be enrolled to achieve 148 evaluable||-0.33|-1.32|
72461881|NCT00914732|144446133|NON_INFERIORITY|The mean difference in log2 transformed peak titers between IMVAMUNE® (1x10\^8 TCID50) liquid formulation subcutaneously (Liquid SC Group) and IMVAMUNE® (2x10\^7 TCID50) formulation intradermally (Liquid ID) with its associated two-sided 97.5% confidence interval (CI) was computed. If the upper limit of the 97.5% CI was less than 1, then the Liquid ID was considered non-inferior to the Liquid SC group. The difference and the CI are reported on the log2 scale.|Mean Difference (Final Values)|0.05|||||TWO_SIDED|97.5|-0.43|0.52||||||The sample size calculations targeted at least 80% power to test non-inferiority for the primary and secondary immunogenicity end points for two investigational arms in reference to a control arm. Assuming a standard deviation of 2.8 for log2 peak PRNT or ELISA titer in each group, a non-inferiority margin of 2.0-fold, a type I error rate of 1.25% (Bonferroni adjusted for 2 comparisons), and drop-out rate of 10%, 165 participants in each group were to be enrolled to achieve 148 evaluable.||0.52|-0.43|
72469754|NCT01434680|144463239|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two-sided 95% CI for the ratio of the hSBA GMTs at 28 days following vaccination was within this equivalence interval, the two vaccine groups would be declared equivalent with respect to the immune response to the vaccines.|hSBA GMT ratios|0.72|||<|0.05|TWO_SIDED|95.0|0.58|0.89|||ANOVA|95% CIs for the GMTs ratios was obtained by exponentiating difference of least square means of log10-transformed titers and both the limits of 95% CIs||The secondary objective was to be assessed only if both primary objectives were met. Because of this, no adjustment for multiplicity was required. MenC-CRM liquid would be declared equivalent to MenC-CRM ROS if the two-sided 95% CI for the ratio of the hSBA GMTs at approximately 28 days following vaccination was within the equivalence interval (0.5, 2.0).||0.89|0.58|<0.05
72461882|NCT00914732|144446134|NON_INFERIORITY|The mean difference in log2 transformed peak titers between IMVAMUNE® (1x10\^8 TCID50) liquid formulation subcutaneously (Liquid SC Group) and IMVAMUNE® (2x10\^7 TCID50) formulation intradermally (Liquid ID) with its associated two-sided 97.5% confidence interval (CI) was computed. If the upper limit of the 97.5% CI was less than 1, then the Liquid ID was considered non-inferior to the Liquid SC group. The difference and the CI are reported on the log2 scale.|Mean Difference (Final Values)|-0.27|||||TWO_SIDED|97.5|-0.77|0.23||||||The sample size calculations targeted at least 80% power to test non-inferiority for the primary and secondary immunogenicity end points for two investigational arms in reference to a control arm. Assuming a standard deviation of 2.8 for log2 peak PRNT or ELISA titer in each group, a non-inferiority margin of 2.0-fold, a type I error rate of 1.25% (Bonferroni adjusted for 2 comparisons), and drop-out rate of 10%, 165 participants in each group were to be enrolled to achieve 148 evaluable.||0.23|-0.77|
72621091|NCT02732145|144773174|SUPERIORITY|"Question: Is there a difference in the frequency of S result (non-specific lesions) in any of the Three Vulvar Rings (S-#-#; S-S-#; S-S-S; S-N-S etc.) in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology?"||||||0.7912|||||||t-test proportion|||"Parameter: The difference in the frequency of S result (non-specific lesions) in any of the Three Vulvar Rings (S-#-#; S-S-#; S-S-S; S-N-S etc.) in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology."||||0.7912
72621092|NCT02732145|144773174|SUPERIORITY|"Question: Is there a difference in the frequency of P result (specific lesions) in any of the Three Vulvar Rings (P-#-#; P-P-; P-P-P; P-N-S etc.) in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology?"||||||1|||||||t-test proportion|||"Parameter: The difference in the frequency of P result (specific lesions) in any of the Three Vulvar Rings (P-#-#; P-P-; P-P-P; P-N-S etc.) in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology."||||1.0000
72621093|NCT02732145|144773175|SUPERIORITY|"Question: Is there a difference in the frequency of N-#-# result (no lesions) of the Outer Vulvar Ring in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology?"||||||0.253|||||||t-test proportion|||"Parameter: The difference in the frequency of N-#-# result (no lesions) of the Outer Vulvar Ring in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology."||||0.2530
72621094|NCT02732145|144773175|SUPERIORITY|"Question: Is there a difference in the frequency of S-#-# result (non-specific lesions) of the Outer Vulvar Ring in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology?"||||||0.8338|||||||t-test proportion|||"Parameter: The difference in the frequency of S-#-# result (non-specific lesions) of the Outer Vulvar Ring in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology."||||0.8338
72461883|NCT00914732|144446137|NON_INFERIORITY|The mean difference in log2 transformed peak titers between IMVAMUNE® (1x10\^8 TCID50) liquid formulation subcutaneously (Liquid SC Group) and IMVAMUNE® (2x10\^7 TCID50) formulation intradermally (Liquid ID) with its associated two-sided 97.5% confidence interval (CI) was computed. If the upper limit of the 97.5% CI was less than 1, then the Liquid ID was considered non-inferior to the Liquid SC group. The difference and the CI are reported on the log2 scale.|Mean Difference (Final Values)|0.34|||||TWO_SIDED|97.5|-0.3|0.71||||||The sample size calculations targeted at least 80% power to test non-inferiority for the primary and secondary immunogenicity end points for two investigational arms in reference to a control arm. Assuming a standard deviation of 2.8 for log2 peak PRNT or ELISA titer in each group, a non-inferiority margin of 2.0-fold, a type I error rate of 1.25% (Bonferroni adjusted for 2 comparisons), and drop-out rate of 10%, 165 participants in each group were to be enrolled to achieve 148 evaluable.||0.71|-0.3|
72461884|NCT00914732|144446138|NON_INFERIORITY|The mean difference in log2 transformed peak titers between IMVAMUNE® (1x10\^8 TCID50) liquid formulation subcutaneously (Liquid SC Group) and IMVAMUNE® (2x10\^7 TCID50) formulation intradermally (Liquid ID) with its associated two-sided 97.5% confidence interval (CI) was computed. If the upper limit of the 97.5% CI was less than 1, then the Liquid ID was considered non-inferior to the Liquid SC group. The difference and the CI are reported on the log2 scale.|Mean Difference (Final Values)|0.02|||||TWO_SIDED|97.5|-0.31|0.35||||||The sample size calculations targeted at least 80% power to test non-inferiority for the primary and secondary immunogenicity end points for two investigational arms in reference to a control arm. Assuming a standard deviation of 2.8 for log2 peak PRNT or ELISA titer in each group, a non-inferiority margin of 2.0-fold, a type I error rate of 1.25% (Bonferroni adjusted for 2 comparisons), and drop-out rate of 10%, 165 participants in each group were to be enrolled to achieve 148 evaluable.||0.35|-0.31|
72461885|NCT00914732|144446139|NON_INFERIORITY|The mean difference in log2 transformed peak titers between IMVAMUNE® (1x10\^8 TCID50) liquid formulation (Liquid SC Group) and IMVAMUNE® (1x10\^8 TCID50) lyophilized formulation (Lyophilized SC) with its associated two-sided 97.5% confidence interval (CI) was computed. If the upper limit of the 97.5% CI was less than 1, then the Lyophilized SC was considered non-inferior to the Liquid SC group. The difference and the CI are reported on the log2 scale.|Mean Difference (Final Values)|-0.35|||||TWO_SIDED|97.5|-0.74|0.04||||||The sample size calculations targeted at least 80% power to test non-inferiority for the primary and secondary immunogenicity end points for two investigational arms in reference to a control arm. Assuming a standard deviation of 2.8 for log2 peak PRNT or ELISA titer in each group, a non-inferiority margin of 2.0-fold, a type I error rate of 1.25% (Bonferroni adjusted for 2 comparisons), and drop-out rate of 10%, 165 participants in each group were to be enrolled to achieve 148 evaluable.||0.04|-0.74|
72469755|NCT01952847|144463279|OTHER|||||||0.73|||||||Wilcoxon (Mann-Whitney)|||||||0.73
72469756|NCT01952847|144463280|OTHER|||||||0.68|||||||Wilcoxon (Mann-Whitney)|||||||0.68
72469757|NCT01952847|144463283|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.00
72469758|NCT01952847|144463284|SUPERIORITY|||||||0.59|||||||Fisher Exact|||||||0.59
72469759|NCT01952847|144463285|SUPERIORITY|||||||0.73|||||||Fisher Exact|||||||0.73
72469760|NCT01952847|144463286|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.00
72469761|NCT01952847|144463287|OTHER|||||||0.54|||||||Wilcoxon (Mann-Whitney)|||||||0.54
72469762|NCT01952847|144463288|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||||||1.00
72469763|NCT01952847|144463289|SUPERIORITY|||||||0.57|||||||Log Rank|||||||0.57
72461886|NCT00914732|144446140|NON_INFERIORITY|The mean difference in log2 transformed peak titers between IMVAMUNE® (1x108 TCID50) liquid formulation (Liquid SC Group) and IMVAMUNE® (1x108 TCID50) lyophilized formulation (Lyophilized SC) with its associated two-sided 97.5% confidence interval (CI) was computed. If the upper limit of the 97.5% CI was less than 1, then the Lyophilized SC was considered non-inferior to the Lyophilized SC group. The difference and the CI are reported on the log2 scale.|Mean Difference (Final Values)|-0.47|||||TWO_SIDED|97.5|-0.81|-0.12||||||The sample size calculations targeted at least 80% power to test non-inferiority for the primary and secondary immunogenicity end points for two investigational arms in reference to a control arm. Assuming a standard deviation of 2.8 for log2 peak PRNT or ELISA titer in each group, a non-inferiority margin of 2.0-fold, a type I error rate of 1.25% (Bonferroni adjusted for 2 comparisons), and drop-out rate of 10%, 165 participants in each group were to be enrolled to achieve 148 evaluable.||-0.12|-0.81|
72461887|NCT03840148|144446144|NON_INFERIORITY|If the lower limit of the 95% CI for the difference in response is greater than or equal to the non-inferiority margin of -15%, non-inferiority will be concluded. Further, if non-inferiority is concluded, superiority will be concluded if the lower limit of the 95% CI for the difference in response is greater than or equal to zero.|Miettinen and Nurminen|12.6||||0.0088|TWO_SIDED|95.0|3.1|22.2||P-value for superiority since the lower confidence interval is greater than 0 for the primary endpoint analysis.|Cochran-Mantel-Haenszel|||||22.2|3.1|0.0088
72461888|NCT03840148|144446145|OTHER||Miettinen and Nurminen|11.7|||||TWO_SIDED|95.0|2.9|21.0||||||||21.0|2.9|
72461889|NCT03840148|144446146|OTHER||Miettinen and Nurminen|4.5|||||TWO_SIDED|95.0|-2.6|12.6||||||||12.6|-2.6|
72461890|NCT03840148|144446147|OTHER||Miettinen and Nurminen|12.3|||||TWO_SIDED|95.0|3.0|21.8||||||||21.8|3.0|
72461891|NCT03840148|144446148|OTHER||Miettinen and Nurminen|3.1|||||TWO_SIDED|95.0|-3.2|10.4||||||||10.4|-3.2|
72461892|NCT03840148|144446149|OTHER||Miettinen and Nurminen|-0.3|||||TWO_SIDED|95.0|-3.5|4.1||||||||4.1|-3.5|
72461893|NCT03840148|144446150|OTHER||Miettinen and Nurminen|1.6|||||TWO_SIDED|95.0|-4.1|8.5||||||||8.5|-4.1|
72461894|NCT03840148|144446151|OTHER||Miettinen and Nurminen|12.1|||||TWO_SIDED|95.0|2.2|21.9||||||||21.9|2.2|
72461895|NCT03840148|144446152|OTHER||Miettinen and Nurminen|7.7|||||TWO_SIDED|95.0|-1.6|17.3||||||||17.3|-1.6|
72461896|NCT03840148|144446153|OTHER||Miettinen and Nurminen|9.9|||||TWO_SIDED|95.0|1.5|18.8||||||||18.8|1.5|
72501756|NCT04321343|144533349|SUPERIORITY||Mean Difference (Final Values)|-7.9|STANDARD_ERROR_OF_MEAN|10.3||0.4413|TWO_SIDED|95.0|-28.25|12.36|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||12.36|-28.25|0.4413
72563600|NCT01098110|144658355|SUPERIORITY_OR_OTHER_LEGACY||Least square (LS) means difference|-2.72|STANDARD_ERROR_OF_MEAN|0.52|<|0.0001|TWO_SIDED|95.0|-3.73|-1.7|||ANCOVA|Change from baseline a response variable, baseline score a covariate, treatment groups and regions as explanatory variables.|Asenapine 5 mg BID minus Placebo BID|||-1.70|-3.73|<0.0001
72563601|NCT01098110|144658355|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-3.08|STANDARD_ERROR_OF_MEAN|0.51|<|0.0001|TWO_SIDED|95.0|-4.09|-2.08|||ANCOVA|Change from baseline a response variable, baseline score a covariate, treatment groups and regions as explanatory variables.|Asenapine 10 mg BID minus Placebo BID|||-2.08|-4.09|<0.0001
72461897|NCT03840148|144446154|OTHER||Miettinen and Nurminen|3.0|||||TWO_SIDED|95.0|-2.4|9.6||||||||9.6|-2.4|
72461898|NCT03840148|144446164|OTHER||Miettinen and Nurminen|3.5|||||TWO_SIDED|95.0|-2.3|10.5||||||||10.5|-2.3|
72461899|NCT03840148|144446165|OTHER||Miettinen and Nurminen|-1.1|||||TWO_SIDED|95.0|-3.1|1.7||||||||1.7|-3.1|
72461900|NCT03840148|144446166|OTHER||Miettinen and Nurminen|14.9|||||TWO_SIDED|95.0|5.0|24.9||||||||24.9|5.0|
72461901|NCT03840148|144446167|OTHER||Miettinen and Nurminen|12.7|||||TWO_SIDED|95.0|3.7|22.3||||||||22.3|3.7|
72461902|NCT03840148|144446168|OTHER||Miettinen and Nurminen|14.0|||||TWO_SIDED|95.0|3.8|24.3||||||||24.3|3.8|
72461903|NCT03840148|144446169|OTHER||Miettinen and Nurminen|7.7|||||TWO_SIDED|95.0|-1.9|17.7||||||||17.7|-1.9|
72461904|NCT03840148|144446174|OTHER||Miettinen and Nurminen|14.0|||||TWO_SIDED|95.0|3.8|24.3||||||||24.3|3.8|
72461905|NCT03840148|144446176|OTHER||Miettinen and Nurminen|1.7|||||TWO_SIDED|95.0|-3.1|7.3||||||||7.3|-3.1|
72461906|NCT03840148|144446177|OTHER||Miettinen and Nurminen|4.8|||||TWO_SIDED|95.0|-1.1|11.5||||||||11.5|-1.1|
72461907|NCT03840148|144446178|OTHER||Miettinen and Nurminen|8.2|||||TWO_SIDED|95.0|1.2|15.7||||||||15.7|1.2|
72461908|NCT04150250|144446208|SUPERIORITY||Difference in Median|-7.1||||0.2254|TWO_SIDED|95.0|-30.9|28.6||The threshold to define success on the primary efficacy endpoint at the final analysis is one-sided alpha = 0.0238.|Van Elteren test|Stratified by blood type group (O vs. Non-O)||||28.6|-30.9|0.2254
72461909|NCT04150250|144446209|SUPERIORITY||Difference in Median|-3.8||||0.2751|TWO_SIDED|95.0|-26.3|27.4|||Van Elteren test|Stratified by blood type group||||27.4|-26.3|0.2751
72461910|NCT04150250|144446211|SUPERIORITY||Difference|-11.3||||0.5145|TWO_SIDED|95.0|-44.1|21.6|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test, stratified by blood type group.||||21.6|-44.1|0.5145
72461911|NCT04150250|144446212|SUPERIORITY||Difference|-6.3||||0.2636|TWO_SIDED|95.0|-18.1|5.6|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test, stratified by blood type group.||||5.6|-18.1|0.2636
72461912|NCT04150250|144446213|SUPERIORITY||Difference in Median|1.1||||0.5992|TWO_SIDED|95.0|-4.5|7.8|||Van Elteren test|Stratified by blood type group||||7.8|-4.5|0.5992
72461913|NCT04150250|144446215|SUPERIORITY|||||||0.6527|||||||Log Rank|Stratified by blood type group||||||0.6527
72461914|NCT04150250|144446216|SUPERIORITY||Difference in Median|1.5||||0.5377|TWO_SIDED|95.0|-7.0|5.5|||Van Elteren test|Stratified by blood type group||||5.5|-7.0|0.5377
72461915|NCT04150250|144446217|SUPERIORITY||Difference|1.3||||0.8705|TWO_SIDED|95.0|-14.0|16.5|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test, stratified by blood type group.||||16.5|-14.0|0.8705
72501757|NCT04321343|144533349|SUPERIORITY||Mean Difference (Final Values)|-17.6|STANDARD_ERROR_OF_MEAN|10.2||0.0859|TWO_SIDED|95.0|-37.63|2.5|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||2.50|-37.63|0.0859
72501758|NCT04321343|144533349|SUPERIORITY||Median Difference (Final Values)|-2.7|STANDARD_ERROR_OF_MEAN|10.0||0.7887|TWO_SIDED|95.0|-22.31|16.97|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||16.97|-22.31|0.7887
72621095|NCT02732145|144773175|SUPERIORITY|"Question: Is there a difference in the frequency of P-#-# result (specific lesions) of the Outer Vulvar Ring in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology?"||||||0.0019|||||||t-test proportion|||"Parameter: The difference in the frequency of P-#-# result (specific lesions) of the Outer Vulvar Ring in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology."||||0.0019
72621096|NCT02732145|144773175|SUPERIORITY|"Question: Is there a difference in the frequency of #-N-# result (no lesions) of the Middle Vulvar Ring in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology?"||||||0.6541|||||||t-test proportion|||"Parameter: The difference in the frequency of #-N-# result (no lesions) of the Middle Vulvar Ring in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology."||||0.6541
72621097|NCT02732145|144773175|SUPERIORITY|"Question: Is there a difference in the frequency of #-S-# result (non-specific lesions) of the Middle Vulvar Ring in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology?"||||||0.8224|||||||t-test proportion|||"Parameter: The difference in the frequency of #-S-# result (non-specific lesions) of the Middle Vulvar Ring in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology."||||0.8224
72392933|NCT00518986|144293393|SUPERIORITY_OR_OTHER|||||||0.1||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.1000
72461916|NCT04150250|144446218|SUPERIORITY||Difference|-18.8||||0.1404|TWO_SIDED|95.0|-41.1|3.6|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test, stratified by blood type group||||3.6|-41.1|0.1404
72461917|NCT03322514|144446244|SUPERIORITY|||||||0.8|||||||t-test, 2 sided|||||||0.8
72461918|NCT03322514|144446244|SUPERIORITY|||||||0.04|||||||t-test, 2 sided|||Baseline to 12 weeks||||0.04
72461919|NCT03322514|144446244|SUPERIORITY|||||||0.1|||||||t-test, 2 sided|||Baseline to 12 weeks||||0.1
72461920|NCT03322514|144446245|SUPERIORITY|||||||0.8|||||||ANOVA|||||||0.8
72461921|NCT03322514|144446245|SUPERIORITY|||||||0.3|||||||t-test, 2 sided|||Baseline to 12 weeks||||0.3
72461922|NCT03322514|144446245|SUPERIORITY|||||||0.3|||||||t-test, 2 sided|||Baseline to 12 weeks||||0.3
72461923|NCT03322514|144446246|SUPERIORITY|||||||0.9|||||||ANOVA|||||||0.9
72461924|NCT03322514|144446246|SUPERIORITY|||||||0.4|||||||t-test, 2 sided|||Baseline to 12 weeks||||0.4
72461925|NCT03322514|144446246|SUPERIORITY|||||||0.7|||||||t-test, 2 sided|||baseline to 12 weeks||||0.7
72461926|NCT01184859|144446247|SUPERIORITY_OR_OTHER|||||||0.211||95.0||||The p-value was not adjusted for multiplicity, because this study was not a confirmatory trial. A priori threshold for statistical significance is 0.05.|t-test, 2 sided|||||||0.211
72392934|NCT00518986|144293394|SUPERIORITY_OR_OTHER|||||||0.2428||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.2428
72461927|NCT01184859|144446247|SUPERIORITY_OR_OTHER|||||||0.01||95.0||||The p-value was not adjusted for multiplicity, because this study was not a confirmatory trial. A priori threshold for statistical significance is 0.05.|t-test, 2 sided|||||||0.010
72461928|NCT01184859|144446247|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The p-value was not adjusted for multiplicity, because this study was not a confirmatory trial. A priori threshold for statistical significance is 0.05.|t-test, 2 sided|||||||<0.001
72461929|NCT01184859|144446247|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The p-value was not adjusted for multiplicity, because this study was not a confirmatory trial. A priori threshold for statistical significance is 0.05.|t-test, 2 sided|||||||<0.001
72461930|NCT01184859|144446248|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.272||||0.194|TWO_SIDED|95.0|-0.685|-0.141||The p-value was not adjusted for multiplicity, because this study was not a confirmatory trial. A priori threshold for statistical significance is 0.05.|ANCOVA|Gender is a factor, and duration of action and baseline number of nocturnal voids are covariates.||||-0.141|-0.685|0.194
72461931|NCT01184859|144446248|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.547||||0.015|TWO_SIDED|95.0|-0.985|-0.108||The p-value was not adjusted for multiplicity, because this study was not a confirmatory trial. A priori threshold for statistical significance is 0.05.|ANCOVA|Gender is a factor, and duration of action and baseline number of nocturnal voids are covariates.||||-0.108|-0.985|0.015
72461932|NCT01184859|144446248|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.854|||<|0.001|TWO_SIDED|95.0|-1.317|-0.391||The p-value was not adjusted for multiplicity, because this study was not a confirmatory trial. A priori threshold for statistical significance is 0.05.|ANCOVA|Gender is a factor, and duration of action and baseline number of nocturnal voids are covariates.||||-0.391|-1.317|<0.001
72461933|NCT01184859|144446248|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.888||||0.001|TWO_SIDED|95.0|-1.426|-0.351||The p-value was not adjusted for multiplicity, because this study was not a confirmatory trial. A priori threshold for statistical significance is 0.05.|ANCOVA|Gender is a factor, and duration of action and baseline number of nocturnal voids are covariates.||||-0.351|-1.426|0.001
72461934|NCT01537120|144446275|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.91|||||TWO_SIDED|90.0|0.85|0.96||||||||0.96|0.85|
72461935|NCT01537120|144446276|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.3|||||TWO_SIDED|90.0|-0.36|-0.23||||||||-0.23|-0.36|
72461936|NCT01537120|144446277|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.46|||||TWO_SIDED|90.0|-0.62|-0.3||||||||-0.30|-0.62|
72461937|NCT02123797|144446319|SUPERIORITY||Odds Ratio (OR)|2.03||||0.0007|TWO_SIDED|95.0|1.35|3.06||Conditional logistic regression adjusted for the matched study design, sex, age, and histology.|Regression, Logistic||Odds ratio comparing Multidisciplinary Clinic patients with and without invasive stage confirmation (numerator=108/70) to Serial Care patients with and without invasive stage confirmation (denominator=168/180) after adjustment for matched study.|||3.06|1.35|0.0007
72469764|NCT01952847|144463293|SUPERIORITY|||||||0.83|||||||Wilcoxon (Mann-Whitney)|||||||0.83
72469765|NCT01952847|144463294|SUPERIORITY|||||||0.39|||||||Wilcoxon (Mann-Whitney)|||||||0.39
72461938|NCT02123797|144446320|SUPERIORITY||Odds Ratio (OR)|1.87||||0.0022|TWO_SIDED|95.0|1.25|2.8||Conditional logistic regression adjusted for the matched study design, sex, age, and histology.|Regression, Logistic||Odds ratio comparing Multidisciplinary Clinic patients with and without invasive mediastinal staging (numerator=91/87) to Serial Care patients with and without mediastinal invasive staging (denominator=126/222) after adjustment for matched study.|||2.80|1.25|0.0022
72461939|NCT02123797|144446321|SUPERIORITY||Odds Ratio (OR)|3.12||||0.0004|TWO_SIDED|95.0|1.67|5.85||Conditional logistic regression adjusted for the matched study design, sex, age, and histology.|Regression, Logistic||Odds ratio comparing Multidisciplinary Clinic patients with and without bi-modal staging (numerator=161/17) to Serial Care patients with and without bi-modal staging (denominator=267/81) after adjustment for matched study design.|||5.85|1.67|0.0004
72461940|NCT02123797|144446322|SUPERIORITY||Odds Ratio (OR)|2.25|||<|0.0001|TWO_SIDED|95.0|1.5|3.36||Conditional logistic regression adjusted for the matched study design, sex, age, and histology.|Regression, Logistic||Odds ratio comparing Multidisciplinary Clinic patients with and without tri-modal staging (numerator=99/79) to Serial Care patients with and without tri-modal staging (denominator=132/216) after adjustment for matched study design.|||3.36|1.50|<0.0001
72461941|NCT02123797|144446323|SUPERIORITY||Odds Ratio (OR)|2.58||||0.0366|TWO_SIDED|95.0|1.665|3.996||Conditional logistic regression adjusted for the matched study design, sex, age, and histology.|Regression, Logistic||Odds ratio comparing Multidisciplinary Clinic patients with and without invasive staging (numerator=108/70) to Serial Care patients not in conference with and without invasive staging (denominator=122/150) after adjustment for matched study design.|||3.996|1.665|0.0366
72461942|NCT02123797|144446323|SUPERIORITY||Odds Ratio (OR)|2.621||||0.0779|TWO_SIDED|95.0|1.473|4.665||Conditional logistic regression adjusted for the matched study design, sex, age, and histology.|Regression, Logistic||Odds ratio comparing Serial Care patients in conference with and without invasive staging (numerator=46/30) to Serial Care patients not in conference with and without invasive staging (denominator=122/150) after adjustment for matched study design.|||4.665|1.473|0.0779
72461943|NCT02123797|144446324|SUPERIORITY||Odds Ratio (OR)|2.358||||0.0703|TWO_SIDED|95.0|1.536|3.621||Conditional logistic regression adjusted for the matched study design, sex, age, and histology.|Regression, Logistic||Odds ratio comparing Multidisciplinary Clinic patients with and without mediastinal staging (numerator=91/87) to Serial Care patients not in conference with and without mediastinal staging (denominator=86/186) after adjustment for matched study.|||3.621|1.536|0.0703
72461944|NCT02123797|144446324|SUPERIORITY||Odds Ratio (OR)|2.535||||0.0631|TWO_SIDED|95.0|1.446|4.444||Conditional logistic regression adjusted for the matched study design, sex, age, and histology.|Regression, Logistic||Odds ratio comparing Serial Care patients in conference with and without mediastinal staging (numerator=40/36) to Serial Care patients not in conference with and without mediastinal staging (denominator=86/186) after adjustment for matched study.|||4.444|1.446|0.0631
72461945|NCT02123797|144446325|SUPERIORITY||Odds Ratio (OR)|3.191||||0.001|TWO_SIDED|95.0|1.671|6.093||Conditional logistic regression adjusted for the matched study design, sex, age, and histology.|Regression, Logistic||Odds ratio comparing Multidisciplinary Clinic patients with and without bi-modal staging (numerator=161/17) to Serial Care patients not in conference with and without bi-modal staging (denominator=205/67) after adjustment for matched study.|||6.093|1.671|0.0010
72461946|NCT02123797|144446325|SUPERIORITY||Odds Ratio (OR)|1.103||||0.1972|TWO_SIDED|95.0|0.526|2.314||Conditional logistic regression adjusted for the matched study design, sex, age, and histology.|Regression, Logistic||Odds ratio comparing Serial Care patients in conference with and without bi-modal staging (numerator=62/14) to Serial Care patients not in conference with and without bi-modal staging (denominator=205/67) after adjustment for matched study.|||2.314|0.526|0.1972
72461947|NCT02123797|144446326|SUPERIORITY||Odds Ratio (OR)|2.739||||0.0055|TWO_SIDED|95.0|1.785|4.203|||Regression, Logistic||Odds ratio comparing Multidisciplinary Clinic patients with and without tri-modal staging (numerator=99/79) to Serial Care patients not in conference with and without tri-modal staging (denominator=93/179) after adjustment for matched study.|||4.203|1.785|0.0055
72461948|NCT02123797|144446326|SUPERIORITY||Odds Ratio (OR)|2.242||||0.2572|TWO_SIDED|95.0|1.287|3.905||Conditional logistic regression adjusted for the matched study design, sex, age, and histology.|Regression, Logistic||Odds ratio comparing Serial Care patients in conference with and without tri-modal staging (numerator=39/37) to Serial Care patients not in conference with and without tri-modal staging (denominator=93/179) after adjustment for matched study.|||3.905|1.287|0.2572
72461949|NCT02123797|144446327|SUPERIORITY||Odds Ratio (OR)|2.01||||0.0045|TWO_SIDED|95.0|1.24|3.25||Conditional logistic regression adjusted for the matched study design, sex, age, and histology.|Regression, Logistic||Odds ratio comparing MD patients with and without stage appropriate treatment (numerator=140/33) to SC patients with and without stage appropriate treatment (denominator=232/106) after adjustment for matched study.|||3.25|1.24|0.0045
72461950|NCT02123797|144446328|SUPERIORITY||Odds Ratio (OR)|2.249||||0.0474|TWO_SIDED|95.0|1.368|3.699||Conditional logistic regression adjusted for the matched study design, sex, age, and histology.|Regression, Logistic||Odds ratio comparing MD patients with and without stage appropriate treatment (numerator=140/33) to SC patients not in conference with and without stage appropriate treatment (denominator=174/91) after adjustment for matched study.|We examined treatment selection practices with or without MD care in a single healthcare system.||3.699|1.368|0.0474
72461951|NCT02123797|144446328|SUPERIORITY||Odds Ratio (OR)|1.751||||0.6353|TWO_SIDED|95.0|0.91|3.37||Conditional logistic regression adjusted for the matched study design, sex, age, and histology.|Regression, Logistic||Odds ratio comparing SC patients in conference with and without stage appropriate treatment (numerator=58/15) to SC patients not in conference with and without stage appropriate treatment (denominator=174/91) after adjustment for matched study.|||3.370|0.910|0.6353
72563602|NCT01098110|144658356|SUPERIORITY_OR_OTHER_LEGACY||Least square (LS) means difference|-1.62|STANDARD_ERROR_OF_MEAN|0.4|<|0.0001|TWO_SIDED|95.0|-2.41|-0.83|||ANCOVA|Change from baseline a response variable, baseline score a covariate, treatment groups and regions as explanatory variables.|Asenapine 5 mg BID minus Placebo BID|||-0.83|-2.41|<0.0001
72563603|NCT01098110|144658356|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-2.26|STANDARD_ERROR_OF_MEAN|0.4|<|0.0001|TWO_SIDED|95.0|-3.04|-1.47|||ANCOVA|Change from baseline a response variable, baseline score a covariate, treatment groups and regions as explanatory variables.|Asenapine 10 mg BID minus Placebo BID|||-1.47|-3.04|<0.0001
72621098|NCT02732145|144773175|SUPERIORITY|"Question: Is there a difference in the frequency of #-P-# result (specific lesions) of the Middle Vulvar Ring in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology?"||||||0.0064|||||||t-test proportion|||"Parameter: The difference in the frequency of #-P-# result (specific lesions) of the Middle Vulvar Ring in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology."||||0.0064
72461952|NCT02123797|144446330|SUPERIORITY||Odds Ratio (OR)|2.955||||0.0014|TWO_SIDED|95.0|1.52|5.747||Conditional logistic regression adjusted for the matched study design, sex, age, and histology.|Regression, Logistic||Odds ratio comparing MD patients with and without concordance to recommendations (numerator=140/37) to SC conference patients with and without concordance to recommendations (denominator=45/30) after adjustment for matched study design.|||5.747|1.520|0.0014
72461953|NCT02123797|144446331|SUPERIORITY||Odds Ratio (OR)|3.093||||0.0019|TWO_SIDED|95.0|1.519|6.299||Conditional logistic regression adjusted for the matched study design, sex, age, and histology.|Regression, Logistic||Odds ratio comparing MD patients with and without concordance to recommendations (numerator=145/32) to SC conference patients with and without concordance to recommendations (denominator=49/26) after adjustment for matched study design.|||6.299|1.519|0.0019
72461954|NCT02123797|144446332|SUPERIORITY||Odds Ratio (OR)|40.892||||0.0499|TWO_SIDED|95.0|1.002|999.999||Conditional logistic regression adjusted for the matched study design, sex, age, and histology.|Regression, Logistic||Odds ratio comparing MD patients with and without concordance to recommendations (numerator=174/3) to SC conference patients with and without concordance to recommendations (denominator=71/4) after adjustment for matched study design.|||999.999|1.002|0.0499
72461955|NCT02123797|144446333|SUPERIORITY||Odds Ratio (OR)|2.663||||0.0263|TWO_SIDED|95.0|1.123|6.319||Conditional logistic regression adjusted for the matched study design, sex, age, and histology.|Regression, Logistic||Odds ratio comparing MD patients with and without concordance to recommendations (numerator=158/19) to SC conference patients with and without concordance to recommendations (denominator=60/15) after adjustment for matched study design.|||6.319|1.123|0.0263
72461956|NCT02123797|144446334|SUPERIORITY||Odds Ratio (OR)|2.566||||0.1503|TWO_SIDED|95.0|0.711|9.269||Conditional logistic regression adjusted for the matched study design, sex, age, and histology.|Regression, Logistic||Odds ratio comparing MD patients with and without concordance to recommendations (numerator=87/14) to SC conference patients with and without concordance to recommendations (denominator=38/8) after adjustment for matched study design.|||9.269|0.711|0.1503
72461957|NCT02123797|144446347|SUPERIORITY|||||||0.0042|||||||Wilcoxon (Mann-Whitney)|||Time from Initial Detection of Lesion to Diagnostic Biopsy||||0.0042
72461958|NCT02123797|144446347|SUPERIORITY|||||||0.0805|||||||Wilcoxon (Mann-Whitney)|||Time from Initial Detection of Lesion to Non-invasive Staging Test||||0.0805
72461959|NCT02123797|144446347|SUPERIORITY|||||||0.0073|||||||Wilcoxon (Mann-Whitney)|||Time from Initial Detection of Lesion to Invasive Staging Test||||0.0073
72461960|NCT02123797|144446347|SUPERIORITY|||||||0.0579|||||||Wilcoxon (Mann-Whitney)|||Time from Initial Detection of Lesion to Definitive Treatment||||0.0579
72461961|NCT02123797|144446348|SUPERIORITY|||||||0.0146|||||||Kruskal-Wallis|||Time from Initial Detection of Lesion to Diagnostic Biopsy||||0.0146
72461962|NCT02123797|144446348|SUPERIORITY|||||||0.16|||||||Kruskal-Wallis|||Time from Initial Detection of Lesion to Non-invasive Staging Test||||0.16
72461963|NCT02123797|144446348|SUPERIORITY|||||||0.0014|||||||Kruskal-Wallis|||Time from Initial Detection of Lesion to Invasive Staging Test||||0.0014
72461964|NCT02123797|144446348|SUPERIORITY|||||||0.0037|||||||Kruskal-Wallis|||Time from Initial Detection of Lesion to Definitive Treatment||||0.0037
72461965|NCT02123797|144446355|SUPERIORITY|||||||0.7506|||||||Log Rank|||||||0.7506
72461966|NCT02123797|144446355|SUPERIORITY||Hazard Ratio (HR)|1.08||||0.54|TWO_SIDED|95.0|0.85|1.36|||Regression, Cox||Comparison is Multidisciplinary/Serial Care.|||1.36|0.85|0.54
72461967|NCT02123797|144446356|SUPERIORITY|||||||0.4847|||||||Log Rank|||||||0.4847
72461968|NCT02123797|144446356|SUPERIORITY||Hazard Ratio (HR)|1.12||||0.51|TWO_SIDED|95.0|0.87|1.43|||Regression, Cox||Comparison is Multidisciplinary/Serial Care Patients Not Presented in Conference|||1.43|0.87|0.51
72461969|NCT02123797|144446356|SUPERIORITY||Hazard Ratio (HR)|1.19||||0.51|TWO_SIDED|95.0|0.84|1.67|||Regression, Cox||Comparison is Serial Care Patients Presented in Conference/Serial Care Patients Not Presented in Conference|||1.67|0.84|0.51
72461970|NCT02123797|144446357|SUPERIORITY|||||||0.9874|||||||Log Rank|||||||0.9874
72461971|NCT02123797|144446357|SUPERIORITY||Hazard Ratio (HR)|1.03||||0.8|TWO_SIDED|95.0|0.82|1.29|||Regression, Cox||Comparison is Multidisciplinary/Serial Care|||1.29|0.82|0.80
72461972|NCT02123797|144446358|SUPERIORITY|||||||0.5377|||||||Log Rank|||||||0.5377
72461973|NCT02123797|144446358|SUPERIORITY||Hazard Ratio (HR)|1.06||||0.73|TWO_SIDED|95.0|0.83|1.34|||Regression, Cox||Comparison is Multidisciplinary/Serial Care Patients Not Presented in Conference|||1.34|0.83|0.73
72461974|NCT02123797|144446358|SUPERIORITY||Hazard Ratio (HR)|1.13||||0.73|TWO_SIDED|95.0|0.82|1.57|||Regression, Cox||Comparison is Serial Care Patients Presented in Conference/Serial Care Patients Not Presented in Conference|||1.57|0.82|0.73
72461975|NCT00443755|144446359|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.001
72461976|NCT00443755|144446360|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.001
72461977|NCT00443755|144446361|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.02
72461978|NCT00443755|144446362|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.001
72461979|NCT00443755|144446363|SUPERIORITY_OR_OTHER|||||||0.03||95.0|||||Wilcoxon (Mann-Whitney)|||P-value is for comparison between groups of the mean change in triglyceride levels.||||0.03
72461980|NCT00443755|144446363|SUPERIORITY_OR_OTHER|||||||0.06||95.0|||||Wilcoxon (Mann-Whitney)|||P-value is for comparison between groups of the mean change in HDL-C levels.||||0.06
72461981|NCT00443755|144446363|SUPERIORITY_OR_OTHER|||||||0.06||95.0|||||Wilcoxon (Mann-Whitney)|||P-value is for comparison between groups of mean change in non-HDL-C levels.||||0.06
72461982|NCT00443755|144446364|SUPERIORITY_OR_OTHER|||||||0.23||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.23
72461983|NCT00443755|144446365|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.002
72461984|NCT00443755|144446366|SUPERIORITY_OR_OTHER|||||||0.13||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.13
72461985|NCT00443755|144446367|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.05
72501759|NCT04321343|144533350|SUPERIORITY||Mean Difference (Final Values)|-5.9|STANDARD_ERROR_OF_MEAN|3.7||0.1166|TWO_SIDED|95.0|-13.19|1.47|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||1.47|-13.19|0.1166
72501760|NCT04321343|144533350|SUPERIORITY||Mean Difference (Final Values)|-11.0|STANDARD_ERROR_OF_MEAN|3.7||0.003|TWO_SIDED|95.0|-18.26|-3.8|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||-3.80|-18.26|0.0030
72563604|NCT01098110|144658357|SUPERIORITY_OR_OTHER_LEGACY||Least square (LS) means difference|-1.41|STANDARD_ERROR_OF_MEAN|0.32|<|0.0001|TWO_SIDED|95.0|-2.04|-0.78|||ANCOVA|Change from baseline a response variable, baseline score a covariate, treatment groups and regions as explanatory variables.|Asenapine 5 mg BID minus Placebo BID|||-0.78|-2.04|<0.0001
72563605|NCT01098110|144658357|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.53|STANDARD_ERROR_OF_MEAN|0.32|<|0.0001|TWO_SIDED|95.0|-2.16|-0.91|||ANCOVA|Change from baseline a response variable, baseline score a covariate, treatment groups and regions as explanatory variables.|Asenapine 10 mg BID minus Placebo BID|||-0.91|-2.16|<0.0001
72461986|NCT00443755|144446368|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.02
72461987|NCT00443755|144446369|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.001
72461988|NCT00443755|144446370|SUPERIORITY_OR_OTHER|||||||0.006||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.006
72461989|NCT00443755|144446371|SUPERIORITY_OR_OTHER|||||||0.18||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.18
72461990|NCT00443755|144446372|SUPERIORITY_OR_OTHER|||||||0.76||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.76
72461991|NCT00376935|144446418|SUPERIORITY_OR_OTHER_LEGACY||Shift parameter|-9.0||||0.1996|ONE_SIDED|98.4||14.0||P-value reported here was not adjusted for multiple comparisons. A 98.4% confidence upper bound for the shift parameter for each comparison adjusted the multiple comparison issues and restricted the familywise Type I error rate at 0.05.|Wilcoxon (Mann-Whitney)|One-sided Wilcoxon rank sum test was used to test the null hypothesis.A 98.4% confidence upper bound for the primary shift parameter was calculated.|The shift parameter (say, X), was calculated as the difference between the distribution of the primary endpoint in the placebo arm and that of in the palifermin arm. X\<0 indicates that palifermen is beneficial.|The null hypothesis is that the distribution of the change in absolute CD4+ lymphocyte counts from baseline to week 12 is the same in the placebo arm and palifermin (20 mcg/kg) arm. The 1-sided alternative hypothesis is that the endpoint distribution is shifted higher in the palifermin (20 mcg/kg) arm.||14||0.1996
72563606|NCT01098110|144658358|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|18.6||||0.0001|TWO_SIDED|95.0|9.2|28.1||Adjusted for region.|Cochran-Mantel-Haenszel||Asenapine 5 mg BID minus Placebo BID|||28.1|9.2|0.0001
72563607|NCT01098110|144658358|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|23.1|||<|0.0001|TWO_SIDED|95.0|13.7|32.6||Adjusted for region.|Cochran-Mantel-Haenszel||Asenapine 10 mg BID minus Placebo BID|||32.6|13.7|<0.0001
72461992|NCT00376935|144446418|SUPERIORITY_OR_OTHER_LEGACY||Shift parameter|-4.0||||0.3135|ONE_SIDED|98.4||17.0||P-value reported here was not adjusted for multiple comparisons. A 98.4% confidence upper bound for the shift parameter for each comparison adjusted the multiple comparison issues and restricted the familywise Type I error rate at 0.05.|Wilcoxon (Mann-Whitney)|One-sided Wilcoxon rank sum test was used to test the null hypothesis.A 98.4% confidence upper bound for the primary shift parameter was calculated.|The shift parameter (say, X), was calculated as the difference between the distribution of the primary endpoint in the placebo arm and that of in the palifermin arm. X\<0 indicates that palifermen is beneficial.|The null hypothesis is that the distribution of the change in absolute CD4+ lymphocyte counts from baseline to week 12 is the same in the placebo arm and palifermin (40 mcg/kg) arm. The 1-sided alternative hypothesis is that the endpoint distribution is shifted higher in the palifermin (40 mcg/kg) arm.||17||0.3135
72461993|NCT00376935|144446418|SUPERIORITY_OR_OTHER_LEGACY||Shift parameter|-4.0||||0.3662|ONE_SIDED|98.4||22.0||P-value reported here was not adjusted for multiple comparisons. A 98.4% confidence upper bound for the shift parameter for each comparison adjusted the multiple comparison issues and restricted the familywise Type I error rate at 0.05.|Wilcoxon (Mann-Whitney)|One-sided Wilcoxon rank sum test was used to test the null hypothesis.A 98.4% confidence upper bound for the primary shift parameter was calculated.|The shift parameter (say, X), was calculated as the difference between the distribution of the primary endpoint in the placebo arm and that of in the palifermin arm. X\<0 indicates that palifermen is beneficial.|The null hypothesis is that the distribution of the change in absolute CD4+ lymphocyte counts from baseline to week 12 is the same in the placebo arm and palifermin (60 mcg/kg) arm. The 1-sided alternative hypothesis is that the endpoint distribution is shifted higher in the palifermin (60 mcg/kg) arm.||22||0.3662
72563608|NCT01098110|144658359|SUPERIORITY_OR_OTHER_LEGACY||Least square (LS) means difference|-0.52|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-0.75|-0.28|||ANCOVA|Change from baseline a response variable, baseline score a covariate, treatment groups and regions as explanatory variables.|Asenapine 5 mg BID minus Placebo BID|||-0.28|-0.75|<0.0001
72501761|NCT04321343|144533350|SUPERIORITY||Mean Difference (Final Values)|-8.8|STANDARD_ERROR_OF_MEAN|3.5||0.0131|TWO_SIDED|95.0|-15.79|-1.87|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||-1.87|-15.79|0.0131
72501762|NCT04321343|144533351|SUPERIORITY||Mean Difference (Final Values)|-1.013|STANDARD_ERROR_OF_MEAN|1.481||0.4963|TWO_SIDED|95.0|-3.9701|1.9436|||Regression, Linear||Mean difference (final values) is the difference in LS Means estimated in the linear regression.|||1.9436|-3.9701|0.4963
72501763|NCT04321343|144533351|SUPERIORITY||Mean Difference (Final Values)|-0.712|STANDARD_ERROR_OF_MEAN|1.402||0.6131|TWO_SIDED|95.0|-3.5109|2.0866|||Regression, Linear||Mean difference (final values) is the difference in LS Means estimated in the linear regression.|||2.0866|-3.5109|0.6131
72501764|NCT04321343|144533351|SUPERIORITY||Mean Difference (Final Values)|-1.441|STANDARD_ERROR_OF_MEAN|1.362||0.2939|TWO_SIDED|95.0|-4.1593|1.2779|||Regression, Linear||Mean difference (final values) is the difference in LS Means estimated in the linear regression.|||1.2779|-4.1593|0.2939
72501765|NCT04321343|144533352|SUPERIORITY||Mean Difference (Final Values)|-0.063|STANDARD_ERROR_OF_MEAN|0.211||0.7672|TWO_SIDED|95.0|-0.4845|0.3589|||Regression, Linear||Mean difference (final values) is the difference in LS Means estimated in the linear regression.|||0.3589|-0.4845|0.7672
72392935|NCT00518986|144293395|SUPERIORITY_OR_OTHER|||||||0.1816||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.1816
72461994|NCT02350127|144446453|SUPERIORITY||Mean Difference (Final Values)|1.79|STANDARD_ERROR_OF_MEAN|1.22||0.14|TWO_SIDED|95.0|-0.59|4.18|||Mixed Models Analysis|||adjusted for participant baseline MOCA, robust VCE||4.18|-0.59|0.14
72461995|NCT02350127|144446453|SUPERIORITY||Mean Difference (Final Values)|2.9|STANDARD_ERROR_OF_MEAN|1.4||0.03|TWO_SIDED|95.0|0.2|5.6|||Mixed Models Analysis|||restricted to completers||5.6|0.2|0.03
72563609|NCT01098110|144658359|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.59|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-0.82|-0.36|||ANCOVA|Change from baseline a response variable, baseline score a covariate, treatment groups and regions as explanatory variables.|Asenapine 10 mg BID minus Placebo BID|||-0.36|-0.82|<0.0001
72563610|NCT01098110|144658360|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|22.2|||<|0.0001|TWO_SIDED|95.0|12.0|32.4||Adjusted for region.|Cochran-Mantel-Haenszel||Asenapine 5 mg BID minus Placebo BID|||32.4|12.0|<0.0001
72392936|NCT00518986|144293396|SUPERIORITY_OR_OTHER|||||||0.1627||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.1627
72461996|NCT02350127|144446454|SUPERIORITY||Mean Difference (Final Values)|-0.22|STANDARD_ERROR_OF_MEAN|0.52||0.68|TWO_SIDED|95.0|-1.23|0.8|||Mixed Models Analysis||Adjusting for baseline participant MOCA scores, robust vce.|||0.80|-1.23|0.68
72461997|NCT02350127|144446455|SUPERIORITY||Mean Difference (Final Values)|-0.51|STANDARD_ERROR_OF_MEAN|1.32||0.7|TWO_SIDED|95.0|-3.09|2.08|||Mixed Models Analysis|||adjusting for baseline participant MOCA, robust VCE||2.08|-3.09|0.70
72461998|NCT02350127|144446456|SUPERIORITY||Mean Difference (Final Values)|5.1|STANDARD_ERROR_OF_MEAN|2.2||0.02|TWO_SIDED|95.0|0.8|9.4|||Mixed Models Analysis|||||9.4|0.8|0.02
72461999|NCT02350127|144446457|SUPERIORITY||Mean Difference (Final Values)|3.1|STANDARD_ERROR_OF_MEAN|4.3||0.47|TWO_SIDED|95.0|-5.4|11.6|||Mixed Models Analysis|||||11.6|-5.4|0.47
72462000|NCT02350127|144446458|SUPERIORITY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.54||0.99|TWO_SIDED|95.0|-1.1|1.1|||Mixed Models Analysis|||||1.1|-1.1|0.99
72462001|NCT02350127|144446459|SUPERIORITY||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|3.7||0.98|TWO_SIDED|95.0|-7.4|7.2|||Mixed Models Analysis|||||7.2|-7.4|0.98
72462002|NCT02350127|144446460|SUPERIORITY||Mean Difference (Final Values)|0.4|STANDARD_ERROR_OF_MEAN|1.5||0.8|TWO_SIDED|95.0|-2.5|3.3|||Mixed Models Analysis|||||3.3|-2.5|0.80
72462003|NCT02350127|144446461|SUPERIORITY||Mean Difference (Final Values)|-1.0|STANDARD_ERROR_OF_MEAN|1.1||0.38|TWO_SIDED|95.0|-3.1|1.2|||Mixed Models Analysis|||||1.2|-3.1|0.38
72462004|NCT02350127|144446462|SUPERIORITY||Mean Difference (Final Values)|-0.8|STANDARD_ERROR_OF_MEAN|0.45||0.075|TWO_SIDED|95.0|-1.7|0.1|||Mixed Models Analysis|||||0.1|-1.7|0.075
72462005|NCT02350127|144446463|SUPERIORITY||Mean Difference (Final Values)|1.6|STANDARD_ERROR_OF_MEAN|1.7||0.35|TWO_SIDED|95.0|-1.7|5.0|||Mixed Models Analysis|||||5.0|-1.7|0.35
72462006|NCT02350127|144446464|SUPERIORITY||Mean Difference (Final Values)|-2.0|STANDARD_ERROR_OF_MEAN|2.1||0.35|TWO_SIDED|95.0|-6.1|2.1|||Mixed Models Analysis|||||2.1|-6.1|0.35
72462007|NCT02350127|144446465|SUPERIORITY||Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|0.3||0.54|TWO_SIDED|95.0|-0.4|0.8|||Mixed Models Analysis|||||0.8|-0.4|0.54
72462008|NCT02350127|144446466|SUPERIORITY||Mean Difference (Final Values)|0.4|STANDARD_ERROR_OF_MEAN|0.9||0.69|TWO_SIDED|95.0|-1.5|2.2|||Mixed Models Analysis|||||2.2|-1.5|0.69
72462009|NCT02350127|144446467|SUPERIORITY||Median Difference (Final Values)|-0.8|STANDARD_ERROR_OF_MEAN|5.2||0.88|TWO_SIDED|95.0|-10.9|9.3|||Mixed Models Analysis|||||9.3|-10.9|0.88
72462010|NCT02350127|144446468|SUPERIORITY||Mean Difference (Final Values)|0.9|STANDARD_ERROR_OF_MEAN|0.8||0.26|TWO_SIDED|95.0|-0.7|2.5|||Mixed Models Analysis|||||2.5|-0.7|0.26
72462011|NCT02350127|144446469|SUPERIORITY||Mean Difference (Final Values)|-1.8|STANDARD_ERROR_OF_MEAN|1.1||0.08|TWO_SIDED|95.0|-3.9|0.2|||Mixed Models Analysis|||||0.2|-3.9|0.08
72462012|NCT03906240|144446474|SUPERIORITY||Cohen's d|1.44|||<|0.001|TWO_SIDED|95.0|1.0|2.49|||t-test, 2 sided|t = 5.78||Paired-samples t-test to conduct within-person comparison between baseline and follow-up.||2.49|1.00|<.001
72462013|NCT03906240|144446474|SUPERIORITY||Cohen's d|0.78||||0.002|TWO_SIDED|95.0|0.35|1.38|||t-test, 2 sided|t = 3.48||Paired-samples t-test to conduct within-person comparison between baseline and follow-up.||1.38|0.35|.002
72462014|NCT03906240|144446475|SUPERIORITY||Cohen's d|0.01||||0.957|TWO_SIDED|95.0|-0.45|0.91|||t-test, 2 sided|t = 0.06||Paired-samples t-test to conduct within-person comparison between baseline and follow-up.||0.91|-0.45|.957
72462015|NCT03906240|144446475|SUPERIORITY||Cohen's d|0.51||||0.033|TWO_SIDED|95.0|0.08|1.25|||t-test, 2 sided|t = 2.30||Paired-samples t-test to conduct within-person comparison between baseline and follow-up.||1.25|0.08|.033
72462016|NCT03906240|144446476|SUPERIORITY||Cohen's d|0.71||||0.015|TWO_SIDED|95.0|0.32|1.31|||t-test, 2 sided|t = 2.76||Physical Domain: Paired-samples t-test to conduct within-person comparison between baseline and follow-up.||1.31|0.32|.015
72462017|NCT03906240|144446476|SUPERIORITY||Cohen's d|0.74||||0.012|TWO_SIDED|95.0|0.26|1.55|||t-test, 2 sided|t = 2.87||Psychological Domain: Paired-samples t-test to conduct within-person comparison between baseline and follow-up.||1.55|0.26|.012
72462018|NCT03906240|144446476|SUPERIORITY||Cohen's d|0.02||||0.941|TWO_SIDED|95.0|-0.43|0.55|||t-test, 2 sided|t = 0.08||Physical Domain: Paired-samples t-test to conduct within-person comparison between baseline and follow-up.||0.55|-0.43|.941
72462019|NCT03906240|144446476|SUPERIORITY||Cohen's d|0.25||||0.27|TWO_SIDED|95.0|-0.17|0.79|||t-test, 2 sided|t = 1.14||Psychological Domain: Paired-samples t-test to conduct within-person comparison between baseline and follow-up.||0.79|-0.17|.270
72462020|NCT03906240|144446477|SUPERIORITY||Cohen's d|0.08||||0.768|TWO_SIDED|95.0|-0.45|0.71|||t-test, 2 sided|t = 0.30||Paired-samples t-test to conduct within-person comparison between baseline and follow-up.||0.71|-0.45|.768
72462021|NCT03906240|144446477|SUPERIORITY||Cohen's d|0.01||||0.975|TWO_SIDED|95.0|-0.53|0.42|||t-test, 2 sided|t = 0.05||Paired-samples t-test to conduct within-person comparison between baseline and follow-up.||0.42|-0.53|.975
72462022|NCT04405089|144446495|OTHER||Linear regression|0.03|||||TWO_SIDED|||||||||Linear regression (number of traumatic brain injuries versus Binge Eating Scale score at baseline).||||
72462023|NCT04405089|144446496|OTHER||Linear regression|-0.33|||||TWO_SIDED|||||||||Linear regression (number of traumatic brain injuries versus NIH Flanker score at baseline).||||
72462024|NCT04405089|144446497|OTHER||Linear regression|0.04|||||TWO_SIDED|||||||||Linear regression (number of traumatic brain injuries versus NIH Set Shifting score at baseline).||||
72462025|NCT03751280|144446498|OTHER||Comparison of adjusted least square mean|0.61|STANDARD_ERROR_OF_MEAN|1.2|||TWO_SIDED|90.0|-1.4|2.6|||||mixed effects model with treatment, visit as fixed effects, baseline and disease duration at baseline as continuous covariates, treatment \* visit and baseline \* visit interaction effects.|Day 29||2.6|-1.4|
72462026|NCT03751280|144446498|OTHER||Comparison of adjusted least square mean|0.8|STANDARD_ERROR_OF_MEAN|1.279|||TWO_SIDED|90.0|-1.3|2.9|||||mixed effects model with treatment, visit as fixed effects, baseline and disease duration at baseline as continuous covariates, treatment \* visit and baseline \* visit interaction effects.|Day 57||2.9|-1.3|
72462027|NCT03751280|144446498|OTHER||Comparison of adjusted least square mean|2.73|STANDARD_ERROR_OF_MEAN|1.611||0.0931|TWO_SIDED|90.0|0.1|5.4|||t-test, 2 sided||mixed effects model with treatment, visit as fixed effects, baseline and disease duration at baseline as continuous covariates, treatment \* visit and baseline \* visit interaction effects.|Day 85||5.4|0.1|0.0931
72462028|NCT03751280|144446500|OTHER||Comparison of adjusted least square mean|0.21|STANDARD_ERROR_OF_MEAN|0.501|||TWO_SIDED|90.0|-0.6|1.0|||||mixed effects model with treatment, visit as fixed effects, baseline and disease duration at baseline as continuous covariates, treatment \* visit and baseline \* visit interaction effects.|Day 29||1|-0.6|
72462029|NCT03751280|144446500|OTHER||Comparison of adjusted least square mean|0.61|STANDARD_ERROR_OF_MEAN|0.538|||TWO_SIDED|90.0|-0.3|1.5|||||mixed effects model with treatment, visit as fixed effects, baseline and disease duration at baseline as continuous covariates, treatment \* visit and baseline \* visit interaction effects.|Day 57||1.5|-0.3|
72462030|NCT03751280|144446500|OTHER||Comparison of adjusted least square mean|0.82|STANDARD_ERROR_OF_MEAN|0.648||0.2069|TWO_SIDED|90.0|-0.3|1.9|||t-test, 2 sided||mixed effects model with treatment, visit as fixed effects, baseline and disease duration at baseline as continuous covariates, treatment \* visit and baseline \* visit interaction effects.|Day 85||1.9|-0.3|0.2069
72462031|NCT03751280|144446501|OTHER||Comparison of adjusted least square mean|0.51|STANDARD_ERROR_OF_MEAN|0.849|||TWO_SIDED|90.0|-0.9|1.9|||||mixed effects model with treatment, visit as fixed effects, baseline and disease duration at baseline as continuous covariates, treatment \* visit and baseline \* visit interaction effects.|Day 29||1.9|-0.9|
72563611|NCT01098110|144658360|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|28.8|||<|0.0001|TWO_SIDED|95.0|18.9|38.8||Adjusted for region.|Cochran-Mantel-Haenszel||Asenapine 10 mg BID minus Placebo BID|||38.8|18.9|<0.0001
72462032|NCT03751280|144446501|OTHER||Comparison of adjusted least square mean|0.12|STANDARD_ERROR_OF_MEAN|0.89|||TWO_SIDED|90.0|-1.4|1.6|||||mixed effects model with treatment, visit as fixed effects, baseline and disease duration at baseline as continuous covariates, treatment \* visit and baseline \* visit interaction effects.|Day 57||1.6|-1.4|
72462033|NCT03751280|144446501|OTHER||Comparison of adjusted least square mean|1.61|STANDARD_ERROR_OF_MEAN|1.071||0.1368|TWO_SIDED|90.0|-0.2|3.4|||t-test, 2 sided|||Day 85||3.4|-0.2|0.1368
72462034|NCT03751280|144446502|OTHER||Comparison of adjusted least square mean|-0.13|STANDARD_ERROR_OF_MEAN|0.43|||TWO_SIDED|90.0|-0.8|0.6|||||mixed effects model with treatment, visit as fixed effects, baseline and disease duration at baseline as continuous covariates, treatment \* visit and baseline \* visit interaction effects.|Day 29||0.6|-0.8|
72462035|NCT03751280|144446502|OTHER||Comparison of adjusted least square mean|0.15|STANDARD_ERROR_OF_MEAN|0.453|||TWO_SIDED|90.0|-0.6|0.9|||||mixed effects model with treatment, visit as fixed effects, baseline and disease duration at baseline as continuous covariates, treatment \* visit and baseline \* visit interaction effects.|Day 57||0.9|-0.6|
72462036|NCT03751280|144446502|OTHER||Comparison of adjusted least square mean|0.51|STANDARD_ERROR_OF_MEAN|0.581||0.3798|TWO_SIDED|90.0|-0.5|1.5|||t-test, 2 sided||mixed effects model with treatment, visit as fixed effects, baseline and disease duration at baseline as continuous covariates, treatment \* visit and baseline \* visit interaction effects.|||1.5|-0.5|0.3798
72462037|NCT03751280|144446503|OTHER||Comparison of adjusted least square mean|-0.79|STANDARD_ERROR_OF_MEAN|-0.79|||TWO_SIDED|90.0|-3.2|1.6|||||mixed effects model with treatment, visit as fixed effects, baseline and disease duration at baseline as continuous covariates, treatment \* visit and baseline \* visit interaction effects.|Day 29||1.6|-3.2|
72462038|NCT03751280|144446503|OTHER||Comparison of adjusted least square mean|-1.6|STANDARD_ERROR_OF_MEAN|2.006|||TWO_SIDED|90.0|-4.9|1.7|||||mixed effects model with treatment, visit as fixed effects, baseline and disease duration at baseline as continuous covariates, treatment \* visit and baseline \* visit interaction effects.|Day 57||1.7|-4.9|
72462039|NCT03751280|144446503|OTHER||Comparison of adjusted least square mean|-4.07|STANDARD_ERROR_OF_MEAN|1.78||0.0245|TWO_SIDED|90.0|-7.0|-1.1|||t-test, 2 sided||mixed effects model with treatment, visit as fixed effects, baseline and disease duration at baseline as continuous covariates, treatment \* visit and baseline \* visit interaction effects.|Day 85||-1.1|-7.0|0.0245
72462040|NCT03751280|144446504|OTHER||Comparison of adjusted least square mean|-0.18|STANDARD_ERROR_OF_MEAN|0.516|||TWO_SIDED|90.0|-1.0|0.7|||||mixed effects model with treatment, visit as fixed effects, baseline and disease duration at baseline as continuous covariates, treatment \* visit and baseline \* visit interaction effects.|Day 29-Domain 1||0.7|-1.0|
72501766|NCT04321343|144533352|SUPERIORITY||Mean Difference (Final Values)|-0.127|STANDARD_ERROR_OF_MEAN|0.198||0.5233|TWO_SIDED|95.0|-0.5216|0.2678|||Regression, Linear||Mean difference (final values) is the difference in LS Means estimated in the linear regression.|||0.2678|-0.5216|0.5233
72501767|NCT04321343|144533352|SUPERIORITY||Mean Difference (Final Values)|-0.279|STANDARD_ERROR_OF_MEAN|0.18||0.1263|TWO_SIDED|95.0|-0.6376|0.0805|||Regression, Linear||Mean difference (final values) is the difference in LS Means estimated in the linear regression.|||0.0805|-0.6376|0.1263
72501768|NCT04321343|144533353|SUPERIORITY||Mean Difference (Final Values)|-0.028|STANDARD_ERROR_OF_MEAN|0.165||0.8662|TWO_SIDED|95.0|-0.3559|0.3002|||Regression, Linear||Mean difference (final values) is the difference in LS Means estimated in the linear regression.|||0.3002|-0.3559|0.8662
72392937|NCT00518986|144293397|SUPERIORITY_OR_OTHER|||||||0.0018||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0018
72462041|NCT02162771|144446538|EQUIVALENCE|The 90% CIs of the ratios of geometric means of log-transformed values were used to assess the bioequivalence between CT-P10 and Rituxan (bioequivalence range of 80% to 125%)|Ratio of geometric least square means|102.25|||||TWO_SIDED|90.0|94.05|111.17|||ANCOVA|Country, gender, race, the value of ECOG status and the FLIPI score (0 to 2 versus 3 to 5) at baseline were fitted as covariates.||Equivalence in AUCtau between CT-P10 and Rituxan||111.17|94.05|
72462042|NCT02162771|144446539|EQUIVALENCE|The 90% CIs of the ratios of geometric means of log-transformed transformed values were used to assess the bioequivalence between CT-P10 and Rituxan (bioequivalence range of 80% to 125%)|Ratio of geometric least square means|100.67|||||TWO_SIDED|90.0|93.84|108.0|||ANCOVA|Country, gender, race, the value of ECOG status and the FLIPI score (0 to 2 versus 3 to 5) at baseline were fitted as covariates.||Equivalence in Cmax,ss between CT-P10 and Rituxan||108.00|93.84|
72462043|NCT02162771|144446540|NON_INFERIORITY|Non-inferiority margin of -7% was predefined.|Point estimate difference|4.3|||||TWO_SIDED|||||||||||||
72501769|NCT04321343|144533353|SUPERIORITY||Mean Difference (Final Values)|-0.094|STANDARD_ERROR_OF_MEAN|0.166||0.5726|TWO_SIDED|95.0|-0.4253|0.2369|||Regression, Linear||Mean difference (final values) is the difference in LS Means estimated in the linear regression.|||0.2369|-0.4253|0.5726
72501770|NCT04321343|144533353|SUPERIORITY||Mean Difference (Final Values)|-0.186|STANDARD_ERROR_OF_MEAN|0.153||0.2289|TWO_SIDED|95.0|-0.4907|0.1192|||Regression, Linear||Mean difference (final values) is the difference in LS Means estimated in the linear regression.|||0.1192|-0.4907|0.2289
72501771|NCT04321343|144533354|SUPERIORITY||Mean Difference (Final Values)|-0.045|STANDARD_ERROR_OF_MEAN|0.254||0.8595|TWO_SIDED|95.0|-0.5509|0.4607|||Regression, Linear||Mean difference (final values) is the difference in LS Means estimated in the linear regression.|||0.4607|-0.5509|0.8595
72392938|NCT00518986|144293398|SUPERIORITY_OR_OTHER|||||||0.0096||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0096
72462044|NCT03594266|144446584|OTHER||||||<|0.0001|||||||paired t-test, two-sided|||||||<0.0001
72462045|NCT03594266|144446584|OTHER||||||<|0.0001|||||||paired t-test, two-sided|||||||<0.0001
72462046|NCT03594266|144446585|OTHER|||||||0.5482|||||||two-sample t-test, 2-sided|||||||0.5482
72462047|NCT03647709|144446592|OTHER||mean score|1.0|||||TWO_SIDED|95.0|0.9|1.2|||||Represents patients pain score post operative day 1 best with rest|Comparison of change in patient's reported pain with rest or during activity at various time intervals. Patients reported best and worst pain scores at rest and during activity.||1.2|0.9|
72462048|NCT03647709|144446592|OTHER||mean score|2.4|||||TWO_SIDED|95.0|2.2|2.6|||||Represents patients reported pain score post operative day 1 worst at rest|Comparison of change in patient's reported pain with rest or during activity at various time intervals. Patients reported best and worst pain scores at rest and during activity.||2.6|2.2|
72462049|NCT03647709|144446592|OTHER||mean score|2.9|||||TWO_SIDED|95.0|2.7|3.1|||||Represents patients reported pain score post operative day 1 best with activity|Comparison of change in patient's reported pain with rest or during activity at various time intervals. Patients reported best and worst pain scores at rest and during activity||3.1|2.7|
72462050|NCT03647709|144446592|OTHER||mean score|4.6|||||TWO_SIDED|95.0|4.4|4.8|||||Represents patients reported pain score post operative day 1 worst with activity|Comparison of change in patient's reported pain with rest or during activity at various time intervals. Patients reported best and worst pain scores at rest and during activity||4.8|4.4|
72501772|NCT04321343|144533354|SUPERIORITY||Mean Difference (Final Values)|-0.222|STANDARD_ERROR_OF_MEAN|0.25||0.3776|TWO_SIDED|95.0|-0.7194|0.2759|||Regression, Linear||Mean difference (final values) is the difference in LS Means estimated in the linear regression.|||0.2759|-0.7194|0.3776
72501773|NCT04321343|144533354|SUPERIORITY||Mean Difference (Final Values)|-0.48|STANDARD_ERROR_OF_MEAN|0.232||0.0424|TWO_SIDED|95.0|-0.9426|0.017|||Regression, Linear||Mean difference (final values) is the difference in LS Means estimated in the linear regression.|||0.0170|-0.9426|0.0424
72501774|NCT04321343|144533355|SUPERIORITY||Odds Ratio (OR)|3.31||||0.1084|TWO_SIDED|95.0|0.775|14.152|||Cochran-Mantel-Haenszel|||||14.152|0.775|0.1084
72501775|NCT04321343|144533355|SUPERIORITY||Odds Ratio (OR)|4.11||||0.0562|TWO_SIDED|95.0|0.959|17.594|||Cochran-Mantel-Haenszel|||||17.594|0.959|0.0562
72501776|NCT04321343|144533355|SUPERIORITY||Odds Ratio (OR)|1.87||||0.3333|TWO_SIDED|95.0|0.501|6.948|||Cochran-Mantel-Haenszel|||||6.948|0.501|0.3333
72501777|NCT04321343|144533356|SUPERIORITY||Odds Ratio (OR)|1.21||||0.7677|TWO_SIDED|95.0|0.345|4.23|||Cochran-Mantel-Haenszel|||||4.230|0.345|0.7677
72501778|NCT04321343|144533356|SUPERIORITY||Odds Ratio (OR)|1.62||||0.4828|TWO_SIDED|95.0|0.434|6.012|||Cochran-Mantel-Haenszel|||||6.012|0.434|0.4828
72501779|NCT04321343|144533356|SUPERIORITY||Odds Ratio (OR)|1.97||||0.2711|TWO_SIDED|95.0|0.598|6.486|||Cochran-Mantel-Haenszel|||||6.486|0.598|0.2711
72501780|NCT04321343|144533357|SUPERIORITY||Odds Ratio (OR)|1.44||||0.5981|TWO_SIDED|95.0|0.376|5.547|||Cochran-Mantel-Haenszel|||||5.547|0.376|0.5981
72501781|NCT04321343|144533357|SUPERIORITY||Odds Ratio (OR)|1.42||||0.6228|TWO_SIDED|95.0|0.363|5.572|||Cochran-Mantel-Haenszel|||||5.572|0.363|0.6228
72501782|NCT04321343|144533357|SUPERIORITY||Odds Ratio (OR)|0.9||||0.8799|TWO_SIDED|95.0|0.245|3.323|||Cochran-Mantel-Haenszel|||||3.323|0.245|0.8799
72501783|NCT04321343|144533358|SUPERIORITY||Odds Ratio (OR)|3.28||||0.1474|TWO_SIDED|95.0|0.625|17.208|||Cochran-Mantel-Haenszel|||||17.208|0.625|0.1474
72501784|NCT04321343|144533358|SUPERIORITY||Odds Ratio (OR)|2.65||||0.262|TWO_SIDED|95.0|0.481|14.631|||Cochran-Mantel-Haenszel|||||14.631|0.481|0.2620
72501785|NCT04321343|144533358|SUPERIORITY||Odds Ratio (OR)|0.7||||0.6935|TWO_SIDED|95.0|0.117|4.133|||Cochran-Mantel-Haenszel|||||4.133|0.117|0.6935
72501786|NCT04321343|144533359|SUPERIORITY||Mean Difference (Final Values)|-0.07|STANDARD_ERROR_OF_MEAN|0.14||0.6384|TWO_SIDED|95.0|-0.35|0.215|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||0.215|-0.350|0.6384
72462051|NCT03647709|144446592|OTHER||mean score|1.8|||||TWO_SIDED|95.0|1.6|2.0|||||Represents patients reported pain score post operative day 2 best at rest|Comparison of change in patient's reported pain with rest or during activity at various time intervals. Patients reported best and worst pain scores at rest and during activity||2.0|1.6|
72462052|NCT03647709|144446592|OTHER||mean score|3.4|||||TWO_SIDED|95.0|3.2|3.6|||||Represents patients reported pain score post operative day 2 worst at rest|Comparison of change in patient's reported pain with rest or during activity at various time intervals. Patients reported best and worst pain scores at rest and during activity||3.6|3.2|
72462053|NCT03647709|144446592|OTHER||mean score|4.2|||||TWO_SIDED|95.0|4.0|4.4|||||Represents patients reported pain score post operative day 2 best with activity|Comparison of change in patient's reported pain with rest or during activity at various time intervals. Patients reported best and worst pain scores at rest and during activity||4.4|4.0|
72462054|NCT03647709|144446592|OTHER||mean score|5.9|||||TWO_SIDED|95.0|5.7|6.1|||||Represents patients reported pain score post operative day 2 worst with activity|Comparison of change in patient's reported pain with rest or during activity at various time intervals. Patients reported best and worst pain scores at rest and during activity||6.1|5.7|
72462055|NCT03647709|144446592|OTHER||mean score|1.0|||||TWO_SIDED|95.0|0.8|1.2|||||Represents patients reported pain score post operative day 3 best at rest|Comparison of change in patient's reported pain with rest or during activity at various time intervals. Patients reported best and worst pain scores at rest and during activity||1.2|0.8|
72462056|NCT03647709|144446592|OTHER||mean score|2.4|||||TWO_SIDED|95.0|2.2|2.6|||||Represents patients reported pain score post operative day 3 worst at rest|Comparison of change in patient's reported pain with rest or during activity at various time intervals. Patients reported best and worst pain scores at rest and during activity||2.6|2.2|
72462057|NCT03647709|144446592|OTHER||mean score|3.3|||||TWO_SIDED|95.0|3.1|3.5|||||Represents patients reported pain score post operative day 3 best with activity|Comparison of change in patient's reported pain with rest or during activity at various time intervals. Patients reported best and worst pain scores at rest and during activity||3.5|3.1|
72462058|NCT03647709|144446592|OTHER||mean score|5.0|||||TWO_SIDED|95.0|4.8|5.2|||||Represents patients reported pain score post operative day 3 worst with activity|Comparison of change in patient's reported pain with rest or during activity at various time intervals. Patients reported best and worst pain scores at rest and during activity||5.2|4.8|
72462059|NCT03647709|144446592|OTHER||mean score|0.5|||||TWO_SIDED|95.0|0.4|0.7|||||Represents patients reported pain score post operative days 10-14 best at rest|Comparison of change in patient's reported pain with rest or during activity at various time intervals. Patients reported best and worst pain scores at rest and during activity||0.7|0.4|
72462060|NCT03647709|144446592|OTHER||mean score|2.1|||||TWO_SIDED|95.0|1.9|2.3|||||Represents patients reported pain score post operative days 10-14 worst at rest|Comparison of change in patient's reported pain with rest or during activity at various time intervals. Patients reported best and worst pain scores at rest and during activity||2.3|1.9|
72462061|NCT03647709|144446592|OTHER||mean score|2.0|||||TWO_SIDED|95.0|1.8|2.2|||||Represents patients reported pain score post operative days 10-14 best with activity|Comparison of change in patient's reported pain with rest or during activity at various time intervals. Patients reported best and worst pain scores at rest and during activity||2.2|1.8|
72501787|NCT04321343|144533359|SUPERIORITY||Mean Difference (Final Values)|-0.27|STANDARD_ERROR_OF_MEAN|0.14||0.0549|TWO_SIDED|95.0|-0.547|0.006|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||0.006|-0.547|0.0549
72462062|NCT03647709|144446592|OTHER||mean score|4.0|||||TWO_SIDED|95.0|3.8|4.2|||||Represents patients reported pain score post operative days 10-14 worst with activity|Comparison of change in patient's reported pain with rest or during activity at various time intervals. Patients reported best and worst pain scores at rest and during activity||4.2|3.8|
72462063|NCT03647709|144446592|OTHER||mean score|0.3|||||TWO_SIDED|95.0|0.2|0.4|||||Represents patients reported pain score post operative week 3 best at rest|Comparison of change in patient's reported pain with rest or during activity at various time intervals. Patients reported best and worst pain scores at rest and during activity||0.4|0.2|
72462064|NCT03647709|144446592|OTHER||mean score|1.5|||||TWO_SIDED|95.0|1.3|1.7|||||Represents patients reported pain score post operative week 3 worst at rest|Comparison of change in patient's reported pain with rest or during activity at various time intervals. Patients reported best and worst pain scores at rest and during activity||1.7|1.3|
72462065|NCT03647709|144446592|OTHER||mean score|1.3|||||TWO_SIDED|95.0|1.2|1.5|||||Represents patients reported pain score post operative week 3 best with activity|Comparison of change in patient's reported pain with rest or during activity at various time intervals. Patients reported best and worst pain scores at rest and during activity||1.5|1.2|
72462066|NCT03647709|144446592|OTHER||mean score|3.1|||||TWO_SIDED|95.0|2.9|3.3|||||Represents patients reported pain score post operative week 3 worst with activity|Comparison of change in patient's reported pain with rest or during activity at various time intervals. Patients reported best and worst pain scores at rest and during activity||3.3|2.9|
72462067|NCT03647709|144446592|OTHER||mean score|0.1|||||TWO_SIDED|95.0|0.0|0.2|||||Represents patients reported pain score post operative week 6 best at rest|Comparison of change in patient's reported pain with rest or during activity at various time intervals. Patients reported best and worst pain scores at rest and during activity||0.2|0.0|
72501788|NCT04321343|144533359|SUPERIORITY||Mean Difference (Final Values)|-0.41|STANDARD_ERROR_OF_MEAN|0.14||0.003|TWO_SIDED|95.0|-0.683|-0.142|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||-0.142|-0.683|0.0030
72501789|NCT04321343|144533360|SUPERIORITY||Mean Difference (Final Values)|-0.051|STANDARD_ERROR_OF_MEAN|0.389||0.8961|TWO_SIDED|95.0|-0.8165|0.7149|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||0.7149|-0.8165|0.8961
72501790|NCT04321343|144533360|SUPERIORITY||Mean Difference (Final Values)|0.163|STANDARD_ERROR_OF_MEAN|0.384||0.671|TWO_SIDED|95.0|-0.5935|0.9204|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||0.9204|-0.5935|0.6710
72462068|NCT03647709|144446592|OTHER||mean score|0.7|||||TWO_SIDED|95.0|0.5|0.8|||||Represents patients reported pain score post operative week 6 worst at rest|Comparison of change in patient's reported pain with rest or during activity at various time intervals. Patients reported best and worst pain scores at rest and during activity||0.8|0.5|
72462069|NCT03647709|144446592|OTHER||mean score|0.5|||||TWO_SIDED|95.0|0.4|0.6|||||Represents patients reported pain score post operative week 6 best with activity|Comparison of change in patient's reported pain with rest or during activity at various time intervals. Patients reported best and worst pain scores at rest and during activity||0.6|0.4|
72462070|NCT03647709|144446592|OTHER||mean score|1.9|||||TWO_SIDED|95.0|1.7|2.0|||||Represents patients reported pain score post operative week 6 worst with activity|Comparison of change in patient's reported pain with rest or during activity at various time intervals. Patients reported best and worst pain scores at rest and during activity||2.0|1.7|
72462071|NCT03647709|144446592|OTHER||mean score|0.0|||||TWO_SIDED|95.0|0.0|0.0|||||Represents patients reported pain score post operative week 12 best at rest|Comparison of change in patient's reported pain with rest or during activity at various time intervals. Patients reported best and worst pain scores at rest and during activity||0.0|-0.0|
72462072|NCT03647709|144446592|OTHER||mean score|0.2|||||TWO_SIDED|95.0|0.1|0.2|||||Represents patients reported pain score post operative week 12 worst at rest|Comparison of change in patient's reported pain with rest or during activity at various time intervals. Patients reported best and worst pain scores at rest and during activity||0.2|0.1|
72462073|NCT03647709|144446592|OTHER||mean score|0.0|||||TWO_SIDED|95.0|0.0|0.1|||||Represents patients reported pain score post operative week 12 best with activity|Comparison of change in patient's reported pain with rest or during activity at various time intervals. Patients reported best and worst pain scores at rest and during activity||0.1|-0.0|
72462074|NCT03647709|144446592|OTHER||mean score|0.5|||||TWO_SIDED|95.0|0.4|0.7|||||Represents patients reported pain score post operative week 12 worst with activity|Comparison of change in patient's reported pain with rest or during activity at various time intervals. Patients reported best and worst pain scores at rest and during activity||0.7|0.4|
72462075|NCT03647709|144446595|OTHER|||||||0.0015|||||||Fisher Exact|||||||0.0015
72462076|NCT03647709|144446596|OTHER|||||||0.6398|||||||Fisher Exact|||||||.6398
72462077|NCT03647709|144446597|OTHER|||||||0.0658|||||||Fisher Exact|||||||.0658
72462078|NCT03647709|144446598|OTHER|||||||1|||||||Fisher Exact|||||||1.0000
72462079|NCT00449033|144446599|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.98||||0.401||95.0|0.83|1.16|||Log Rank|Two treatment groups compared using a log-rank test with one-sided alpha of 0.025 stratified by the same stratification factors as randomization.||Sample size based on the primary efficacy endpoint of OS in the ITT (non-squamous) population. Clinically meaningful improvement defined as 30% increase in median OS (that is, a hazard ratio of 0.76923, Sorafenib+GC over Placebo+GC). With one-sided alpha of 0.025, power of 86% and a randomization ratio of 1:1 between Sorafenib+GC and Placebo+GC, and one formal final analysis of OS performed, a total of 544 events (deaths) were required.||1.16|0.83|0.401
72462080|NCT00449033|144446600|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.01||||0.563||95.0|0.87|1.18|||Log Rank|Two treatment groups compared using a log-rank test with one-sided alpha of 0.025 stratified by the same factors as randomization plus histology.||||1.18|0.87|0.563
72462081|NCT00449033|144446602|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.83||||0.008||95.0|0.71|0.97|||Log Rank|Two treatment groups compared using a log-rank test with one-sided alpha of 0.025 stratified by the same stratification factors as randomization.||||0.97|0.71|0.008
72462082|NCT00449033|144446603|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.73||||0.0004||95.0|0.6|0.88|||Log Rank|Two treatment groups compared using a log-rank test with one-sided alpha of 0.025 stratified by the same stratification factors as randomization.||||0.88|0.60|0.0004
72462083|NCT00449033|144446604|SUPERIORITY_OR_OTHER||Difference in Tumour Response (CR+PR)|-1.92||||0.2733||95.0|-8.19|4.34|||Cochran-Mantel-Haenszel|Two treatment groups compared using a CMH test with one-sided alpha of 0.025 stratified by the same stratification factors as randomization.||||4.34|-8.19|0.2733
72462084|NCT00449033|144446605|SUPERIORITY_OR_OTHER||Difference in Disease Control|0.97||||0.3902||95.0|-5.87|7.81|||Cochran-Mantel-Haenszel|Two treatment groups compared using a CMH test with one-sided alpha of 0.025 stratified by the same stratification factors as randomization.||||7.81|-5.87|0.3902
72462085|NCT00024102|144446638|NON_INFERIORITY_OR_EQUIVALENCE|The primary measure of efficacy was the hazard ratio for disease recurrence or death in the capecitabine group as compared with the standard chemotherapy group. Capecitabine would be considered noninferior to standard chemotherapy if the hazard ratio was greater than 0.8046. (With the use of a 5-year landmark for descriptive purposes, this ratio corresponds to a 5-year rate of relapse-free survival of 60% for standard chemotherapy and 53% for capecitabine.)|Hazard Ratio (HR)|2.09|||<|0.001|TWO_SIDED|95.0|1.38|3.17||Multivariate proportional hazards regression used to test for an arm effect was adjusted for tumor size, number of lymph nodes and hormone-receptor status. A priori formal monitoring for futility and noninferiority was planned at accrual milestones|Regression, Cox|||||3.17|1.38|<0.001
72462086|NCT00024102|144446639|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.85||||0.02|TWO_SIDED|95.0|1.11|3.08||Multivariate proportional hazards regression used to test for an arm effect was adjusted for tumor size, number of lymph nodes and hormone-receptor status. There is no adjustment for multiple comparisons.|Regression, Cox|||||3.08|1.11|0.02
72462087|NCT01770509|144446656|SUPERIORITY_OR_OTHER|||||||0.652|||||||ANOVA|General Linear Model ANOVA with repeated measures||||||0.652
72462088|NCT01770509|144446657|SUPERIORITY_OR_OTHER|||||||0.645|||||||ANOVA|General Linear Model ANOVA with repeated measures||||||0.645
72462089|NCT00603278|144446677|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.207|||<|0.001|TWO_SIDED|95.0|0.096|0.318|||ANCOVA|||||0.318|0.096|<0.001
72462090|NCT00603278|144446677|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.238|||<|0.001|TWO_SIDED|95.0|0.127|0.349|||ANCOVA|||||0.349|0.127|<0.001
72462091|NCT00603278|144446677|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.293|||<|0.001|TWO_SIDED|95.0|0.182|0.404|||ANCOVA|||||0.404|0.182|<0.001
72462092|NCT00603278|144446677|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.279|||<|0.001|TWO_SIDED|95.0|0.167|0.392|||ANCOVA|||||0.392|0.167|<0.001
72462093|NCT00603278|144446677|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.225|||<|0.001|TWO_SIDED|95.0|0.114|0.337|||ANCOVA|||||0.337|0.114|<0.001
72462094|NCT01207453|144446721|SUPERIORITY_OR_OTHER|||||||0.42|TWO_SIDED|||||Not adjusted for multiple comparisons. A priori threshold for statistical significance was \< 0.05.|Wilcoxon (Mann-Whitney)|||The difference between the change measured during placebo versus the change during milnacipran treatment. Calculated using Wilcoxon signed rank tests.||||0.42
72462095|NCT01207453|144446721|SUPERIORITY_OR_OTHER|||||||0.37|TWO_SIDED|||||Linear mixed models including treatment, crossover period and treatment sequence. Not adjusted for multiple comparisons. A priori threshold for statistical significance was \< 0.05.|Mixed Models Analysis|||The difference between the change measured during placebo versus the change during milnacipran treatment. Calculated using linear mixed models.||||0.37
72462096|NCT01207453|144446722|SUPERIORITY_OR_OTHER|||||||0.39|TWO_SIDED|||||Not adjusted for multiple comparisons. A priori threshold for statistical significance was \< 0.05.|Wilcoxon (Mann-Whitney)|||The difference between the change measured during placebo versus the change during milnacipran treatment. Calculated using the Wilcoxon signed-rank tests.||||0.39
72462097|NCT01207453|144446722|SUPERIORITY_OR_OTHER|||||||0.96|TWO_SIDED|||||Linear mixed models including treatment, crossover period and treatment sequence. Not adjusted for multiple comparisons. A priori threshold for statistical significance was \< 0.05.|Mixed Models Analysis|||The difference between the change measured during placebo versus the change during milnacipran treatment. Calculated using linear mixed models.||||0.96
72462098|NCT01207453|144446723|SUPERIORITY_OR_OTHER|||||||0.89|TWO_SIDED|||||Not adjusted for multiple comparisons. A priori threshold for statistical significance was \< 0.05.|Wilcoxon (Mann-Whitney)|||The difference between the change measured during placebo versus the change during milnacipran treatment. Calculated using Wilcoxon signed-rank tests.||||0.89
72462099|NCT01207453|144446723|SUPERIORITY_OR_OTHER|||||||0.83|TWO_SIDED|||||Linear mixed models including treatment, crossover period and treatment sequence. Not adjusted for multiple comparisons. A priori threshold for statistical significance was \< 0.05.|Mixed Models Analysis|||The difference between the change measured during placebo versus the change during milnacipran treatment. Calculated using linear mixed models.||||0.83
72462100|NCT01207453|144446724|SUPERIORITY_OR_OTHER|||||||0.04|TWO_SIDED|||||Not adjusted for multiple comparisons. A priori threshold for statistical significance was \< 0.05.|Wilcoxon (Mann-Whitney)|||The difference between the change measured during placebo versus the change during milnacipran treatment. Calculated using Wilcoxon signed-rank tests.||||0.04
72462101|NCT01207453|144446724|SUPERIORITY_OR_OTHER|||||||0.04|TWO_SIDED|||||Linear mixed models including treatment, crossover period and treatment sequence. Not adjusted for multiple comparisons. A priori threshold for statistical significance was \< 0.05.|Mixed Models Analysis|||The difference between the change measured during placebo versus the change during milnacipran treatment. Calculated using linear mixed models.||||0.04
72462102|NCT01207453|144446725|SUPERIORITY_OR_OTHER|||||||0.89|TWO_SIDED|||||Not adjusted for multiple comparisons. A priori threshold for statistical significance was \< 0.05.|Wilcoxon (Mann-Whitney)|||The difference between the change measured during placebo versus the change during milnacipran treatment. Calculated using Wilcoxon signed-rank tests.||||0.89
72462103|NCT01207453|144446725|SUPERIORITY_OR_OTHER|||||||0.44|TWO_SIDED|||||Linear mixed models including treatment, crossover period and treatment sequence. Not adjusted for multiple comparisons. A priori threshold for statistical significance was \< 0.05.|Mixed Models Analysis|||The difference between the change measured during placebo versus the change during milnacipran treatment. Calculated using linear mixed models.||||0.44
72462104|NCT01207453|144446726|SUPERIORITY_OR_OTHER|||||||0.35|TWO_SIDED|||||Not adjusted for multiple comparisons. A priori threshold for statistical significance was \< 0.05.|Wilcoxon (Mann-Whitney)|||The difference between the change measured during placebo versus the change during milnacipran treatment. Calculated using Wilcoxon signed-rank tests.||||0.35
72462105|NCT01207453|144446726|SUPERIORITY_OR_OTHER|||||||0.34|TWO_SIDED|||||Linear mixed models including treatment, crossover period and treatment sequence. Not adjusted for multiple comparisons. A priori threshold for statistical significance was \< 0.05.|Mixed Models Analysis|||The difference between the change measured during placebo versus the change during milnacipran treatment. Calculated using linear mixed models.||||0.34
72462106|NCT01207453|144446727|SUPERIORITY_OR_OTHER|||||||0.72|TWO_SIDED|||||Not adjusted for multiple comparisons. A priori threshold for statistical significance was \< 0.05.|Wilcoxon (Mann-Whitney)|||The difference between the change measured during placebo versus the change during milnacipran treatment. Calculated using Wilcoxon signed-rank tests.||||0.72
72462107|NCT01207453|144446727|SUPERIORITY_OR_OTHER|||||||0.82|TWO_SIDED|||||Linear mixed models including treatment, crossover period and treatment sequence. Not adjusted for multiple comparisons. A priori threshold for statistical significance was \< 0.05.|Mixed Models Analysis|||The difference between the change measured during placebo versus the change during milnacipran treatment. Calculated using linear mixed models.||||0.82
72462108|NCT00546884|144446733|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.16|||<|0.05|TWO_SIDED||||||Chi-squared|||||||<0.05
72462109|NCT02577315|144446734|NON_INFERIORITY_OR_EQUIVALENCE|Assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMeans) with acceptance range of 80.00 to 125.00%|Ratio of geometric means|100.1|||||TWO_SIDED|90.0|97.466|102.804|||ANOVA|Analysis of variance (ANOVA) on log scale was used with subjects within sequences as random, whereas sequence, period and treatment as fixed effects.|Relative bioavailability of Empagliflozin was estimated by the ratios of the adjusted geometric means (gMean).|Empagliflozin / Metformin (FDC) vs. Empagliflozin + Metformin free combination||102.804|97.466|
72462110|NCT02577315|144446735|NON_INFERIORITY_OR_EQUIVALENCE|Assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMeans) with acceptance range of 80.00 to 125.00%|Ratio of geometric means|95.51|||||TWO_SIDED|90.0|89.29|102.16|||ANOVA|Analysis of variance (ANOVA) on log scale was used with subjects within sequences as random, whereas sequence, period and treatment as fixed effects.|Relative bioavailability of Metformin was estimated by the ratios of the adjusted geometric means (gMean).|Empagliflozin / Metformin (FDC) vs. Empagliflozin + Metformin free combination||102.16|89.29|
72462111|NCT02577315|144446736|NON_INFERIORITY_OR_EQUIVALENCE|Assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMeans) with acceptance range of 80.00 to 125.00%|Ratio of geometric means|102.71|||||TWO_SIDED|90.0|97.309|108.413|||ANOVA|Analysis of variance (ANOVA) on log scale was used with subjects within sequences as random, whereas sequence, period and treatment as fixed effects.|Relative bioavailability of Empagliflozin was estimated by the ratios of the adjusted geometric means (gMean).|Empagliflozin / Metformin (FDC) vs. Empagliflozin + Metformin free combination||108.413|97.309|
72462112|NCT02577315|144446737|NON_INFERIORITY_OR_EQUIVALENCE|Assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMeans) with acceptance range of 80.00 to 125.00%|Ratio of geometric means|101.07|||||TWO_SIDED|90.0|95.565|106.902|||ANOVA|Analysis of variance (ANOVA) on log scale was used with subjects within sequences as random, whereas sequence, period and treatment as fixed effects.|Relative bioavailability of Metformin was estimated by the ratios of the adjusted geometric means (gMean).|Empagliflozin / Metformin (FDC) vs. Empagliflozin + Metformin free combination||106.902|95.565|
72462113|NCT02577315|144446738|NON_INFERIORITY_OR_EQUIVALENCE|Assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMeans) with acceptance range of 80.00 to 125.00%|Ratio of geometric means|100.3|||||TWO_SIDED|90.0|97.532|103.149|||ANOVA|Analysis of variance (ANOVA) on log scale was used with subjects within sequences as random, whereas sequence, period and treatment as fixed effects.|Relative bioavailability of Empagliflozin was estimated by the ratios of the adjusted geometric means (gMean).|Empagliflozin / Metformin (FDC) vs. Empagliflozin + Metformin free combination||103.149|97.532|
72462114|NCT02577315|144446739|NON_INFERIORITY_OR_EQUIVALENCE|Assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMeans) with acceptance range of 80.00 to 125.00%|Ratio of geometric means|93.55|||||TWO_SIDED|90.0|82.86|105.61|||ANOVA|Analysis of variance (ANOVA) on log scale was used with subjects within sequences as random, whereas sequence, period and treatment as fixed effects.|Relative bioavailability of Metformin was estimated by the ratios of the adjusted geometric means (gMean).|Empagliflozin / Metformin (FDC) vs. Empagliflozin + Metformin free combination||105.61|82.86|
72462115|NCT00417989|144446740|NON_INFERIORITY_OR_EQUIVALENCE|Superiority test with margin of 0.35|Mean Difference (Final Values)|0.35|STANDARD_DEVIATION|1.2||0.05|TWO_SIDED|95.0|0.24|0.46||Confidence Interval 95%|ANCOVA|ANVOCA is adjusted by study group, gender, pooled site, continuous age, duration of diabetes, BMI, and Baseline glycated hemoglobin level (A1C)||Null - There is no treatment group difference in A1c change from baseline to Week 52. Calculated that the enrollment of 495 patients would provide a power of 90% to detect an absolute difference of 0.35 percentage points in the primary outcome, assuming a SD of 1.2%.||0.46|0.24|0.05
72462116|NCT00417989|144446742|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.2|STANDARD_DEVIATION|2.0||0.84|TWO_SIDED|95.0|0.64|2.41|||Mantel Haenszel|||||2.41|0.64|0.84
72462117|NCT00417989|144446743|NON_INFERIORITY_OR_EQUIVALENCE|No power calculation based on this endpoint. Results will be calculated on testing for statistical difference between arms.||||||0.05||95.0|||||ANCOVA|ANVOCA is adjusted by study group, gender, pooled site, continuous age, duration of diabetes, BMI, and Baseline AUC||||||0.05
72462118|NCT00417989|144446744|NON_INFERIORITY_OR_EQUIVALENCE|No power calculation based on this endpoint. Results will be calculated on testing for statistical difference between arms.||||||0.05||95.0|||||ANCOVA|ANVOCA is adjusted by study group, gender, pooled site, continuous age, duration of diabetes, BMI, and Baseline AUC||||||0.05
72462119|NCT00417989|144446745|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.5|STANDARD_DEVIATION|16.0|<|0.001||95.0|-9.76|-3.273|||ANCOVA|||||-3.273|-9.760|< 0.001
72563612|NCT02147587|144658361|SUPERIORITY_OR_OTHER||Ratio of GMFR|1.213|||||TWO_SIDED|80.0|1.033|1.424|||ANCOVA|Repeated-measures ANCOVA model for the log-transformed GMFRs are adjusted for baseline factors. GMFRs and 80% CIs are back-transformed from log scale.|Ratio of GMFRs (Tofacitinib/Placebo) at Week 4|Geometric Mean Fold Rise (GMFR) for Tofacitinib versus Placebo (Week 4)||1.424|1.033|
72563613|NCT02147587|144658362|SUPERIORITY_OR_OTHER||Ratio of GMFR|1.03|||||TWO_SIDED|80.0|0.877|1.209|||ANCOVA|Repeated-measures ANCOVA model for the log-transformed GMFRs are adjusted for baseline factors. GMFRs and 80% CIs are back-transformed from log scale.|Ratio of GMFRs (Tofacitinib/Placebo) at Day 1|GMFR for Tofacitinib versus Placebo (Day 1)||1.209|0.877|
72563614|NCT02147587|144658362|SUPERIORITY_OR_OTHER||Ratio of GMFR|1.093|||||TWO_SIDED|80.0|0.924|1.294|||ANCOVA|Repeated-measures ANCOVA model for the log-transformed GMFRs are adjusted for baseline factors. GMFRs and 80% CIs are back-transformed from log scale.|Ratio of GMFRs (Tofacitinib/Placebo) at Week 12|GMFR for Tofacitinib versus Placebo (Week 12)||1.294|0.924|
72563615|NCT02147587|144658363|SUPERIORITY_OR_OTHER||Ratio of GMT|1.063|||||TWO_SIDED|80.0|0.821|1.375|||ANCOVA|Repeated-measures ANCOVA model for the log-transformed GMTs are adjusted for baseline factors. GMTs and 80% CIs are back-transformed from log scale.|Ratio of GMTs (Tofacitinib/Placebo) at Day 1|Geometric Mean Titer (GMT) for Tofacitinib versus Placebo (Day 1)||1.375|0.821|
72563616|NCT02147587|144658363|SUPERIORITY_OR_OTHER||Ratio of GMT|1.251|||||TWO_SIDED|80.0|0.967|1.618|||ANCOVA|Repeated-measures ANCOVA model for the log-transformed GMTs are adjusted for baseline factors. GMTs and 80% CIs are back-transformed from log scale.|Ratio of GMTs (Tofacitinib/Placebo) at Week 4|GMT for Tofacitinib versus Placebo (Week 4)||1.618|0.967|
72621099|NCT02732145|144773175|SUPERIORITY|"Question: Is there a difference in the frequency of #-#-N result (no lesions) of the Inner Vulvar Ring in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology?"||||||0.9723|||||||t-test proportion|||"Parameter: The difference in the frequency of #-#-N result (no lesions) of the Inner Vulvar Ring in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology."||||0.9723
72462120|NCT00417989|144446747|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.0|STANDARD_DEVIATION|7.75|||||||||Mean difference|||||||
72462121|NCT00417989|144446748|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|18.6|STANDARD_DEVIATION|25.53|||TWO_SIDED||||||Mean Difference|||||||
72462122|NCT00748098|144446793|SUPERIORITY_OR_OTHER||Adjusted mean difference versus placebo|-26.0|||<|0.0001|TWO_SIDED|95.0|-35.64|-16.36|||ANCOVA|Estimates were obtained using an ANCOVA model with period, group center, and treatment as fixed effects and participant as a random effect.||||-16.36|-35.64|<0.0001
72462123|NCT00748098|144446794|SUPERIORITY_OR_OTHER||Adjusted mean difference versus placebo|-3.07||||0.002|TWO_SIDED|95.0|-5.04|-1.1|||ANCOVA|Estimates were obtained using an ANCOVA model with period, group center, and treatment as fixed effects and participant as a random effect.||||-1.10|-5.04|0.002
72462124|NCT01232569|144446835|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|29.5|||<|0.001|TWO_SIDED|95.0|22.0|37.0|||Cochran-Mantel-Haenszel|Analysis adjusted for the randomization stratification factors applied at Baseline (region and weight category).||||37.0|22.0|<0.001
72462125|NCT04044352|144446853|OTHER|Likelihood ratio test was the statistical test.|Odds Ratio (OR)|0.81||||0.126|TWO_SIDED|95.0|0.62|1.06|||Wald Chi-Square||A two-fold increase in HAI pre-challenge titer (i.e. one unit increase in log-2 titer) corresponds to a 19% decrease in the odds of developing MMID during the study challenge period (Day 2 through Day 8).|Pre-challenge (baseline) HAI geometric mean titer was log-2 transformed and treated as a continuous variable in the model.||1.06|0.62|0.126
72462126|NCT00396097|144446986|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.006|STANDARD_ERROR_OF_MEAN|0.033||0.5762|ONE_SIDED|97.5|-0.071||||ANCOVA|||The null hypothesis was that the individualized treatment arm was not superior to the standard treatment arm; alternative hypothesis that the individualized treatment arm was superior to the standard treatment arm with respect to the mean 24-month AOTD. Using a 2:1 randomization, a two sided sample t-test comparing the root AOTD between the 2 treatment arms with 80% power at a 5% level required 260 subjects. Assuming a 20% attrition rate, approximately 312 subjects were needed for this study.|||-0.071|0.5762
72462127|NCT00396097|144446987|SUPERIORITY_OR_OTHER|||||||0.627|TWO_SIDED||||||ANOVA (Levene's Test)|||||||0.627
72462128|NCT00396097|144446988|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.033||||0.8016|TWO_SIDED|95.0|0.802|1.33|||Regression, Cox|||||1.330|0.802|0.8016
72462129|NCT00396097|144446989|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.822|STANDARD_ERROR_OF_MEAN|2.25||0.0101|TWO_SIDED|95.0|1.395|10.249|||ANCOVA|||||10.249|1.395|0.0101
72462130|NCT00396097|144446989|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.281|STANDARD_ERROR_OF_MEAN|2.471||0.0002|TWO_SIDED|95.0|4.417|14.145|||ANCOVA|||||14.145|4.417|0.0002
72462131|NCT00396097|144446989|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.204|STANDARD_ERROR_OF_MEAN|2.495||0.2001|TWO_SIDED|95.0|-1.707|8.114|||ANCOVA|||||8.114|-1.707|0.2001
72462132|NCT00396097|144446990|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|36.899|STANDARD_ERROR_OF_MEAN|3.414|<|0.0001|TWO_SIDED|95.0|30.181|43.618|||ANCOVA|||||43.618|30.181|<0.0001
72462133|NCT00396097|144446990|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|48.517|STANDARD_ERROR_OF_MEAN|3.284|<|0.0001|TWO_SIDED|95.0|42.054|54.98|||ANCOVA|||||54.980|42.054|<.0001
72462134|NCT00396097|144446990|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|34.443|STANDARD_ERROR_OF_MEAN|3.306|<|0.0001|TWO_SIDED|95.0|27.936|40.951|||ANCOVA|||||40.951|27.936|<.0001
72563617|NCT02147587|144658363|SUPERIORITY_OR_OTHER||Ratio of GMT|1.121|||||TWO_SIDED|80.0|0.862|1.459|||ANCOVA|Repeated-measures ANCOVA model for the log-transformed GMTs are adjusted for baseline factors. GMTs and 80% CIs are back-transformed from log scale.|Ratio of GMTs (Tofacitinib/Placebo) at Week 12|GMT for Tofacitinib versus Placebo (Week 12)||1.459|0.862|
72462135|NCT00396097|144446991|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.091|STANDARD_ERROR_OF_MEAN|0.081||0.2618|TWO_SIDED|95.0|-0.068|0.249|||ANCOVA|||||0.249|-0.068|0.2618
72462136|NCT00396097|144446991|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.013|STANDARD_ERROR_OF_MEAN|0.094||0.8926|TWO_SIDED|95.0|-0.172|0.198|||ANCOVA|||||0.198|-0.172|0.8926
72462137|NCT00396097|144446991|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.005|STANDARD_ERROR_OF_MEAN|0.095||0.9566|TWO_SIDED|95.0|-0.192|0.181|||ANCOVA|||||0.181|-0.192|0.9566
72462138|NCT04086576|144447030|SUPERIORITY||||||<|0.0001||||||Yes, used Tukey Kramer pairwise comparisons to adjust for multiple comparisons|ANOVA|ANOVA in repeated measures||Each breathalyzer is compared to the percentage of alcohol in the blood during the time of blood draw (90 minutes).||||<.0001
72462139|NCT00475735|144447122|SUPERIORITY_OR_OTHER|||||||0.341||95.0||||Since this is a proof of concept study with one primary hypothesis (AISRS total score for MK-0249 vs. placebo), there is no multiplicity adjustment.|Mixed Models Analysis|The terms were tobacco use, prior stimulant use, time, site, period, sequence, treatment, period-by-time, sequence-by-time, and treatment-by-time.||||||0.341
72462140|NCT00475735|144447122|SUPERIORITY_OR_OTHER|||||||0.001||95.0||||Since this is a proof of concept study with one primary hypothesis (AISRS total score for MK-0249 vs. placebo), there is no multiplicity adjustment.|Mixed Models Analysis|The terms were tobacco use, prior stimulant use, time, site, period, sequence, treatment, period-by-time, sequence-by-time, and treatment-by-time.||||||0.001
72462141|NCT00125853|144447171|OTHER|"Linear Mixed effect Modelling, adjusted for baseline values and period effect~Difference of LSMeans treatment effect (SE) = 0.05 (0.09)"||||||0.6|||||||Linear Mixed effect Modelling, adjusted|||Comparing treatment effects on ISI||||0.60
72462142|NCT00125853|144447172|OTHER|"Linear Mixed effect Model, adjusted for baseline values and period effect~Difference of LSMeans treatment effect (SE)~= -2.59 (1.34)"||||||0.06|||||||Linear Mixed effect Model, adjusted for|||Comparing treatment effects on ABPM||||0.06
72462143|NCT00125853|144447173|OTHER|"Linear Mixed effect Model, adjusted for baseline values and period effect~Difference of LSMeans treatment effect (SE)~= -0/09 (0.14)"||||||0.51|||||||Linear Mixed effect Modelling, adjusted|||Comparing treatment effects on total cholesterol||||0.51
72462144|NCT00125853|144447174|OTHER|"Linear Mixed effect Model, adjusted for baseline values and period effect~Difference of LSMeans treatment effect (SE) =0.02 (0.03)"||||||0.48|||||||Linear Mixed effect Modelling, adjusted|||Comparing treatment effects on HbA1c||||0.48
72462145|NCT00125853|144447175|OTHER|"Linear Mixed effect Model, adjusted for baseline values and period effect~Difference of LSMeans treatment effect (SE)~= -0.21(0.13)"||||||0.09|||||||Linear Mixed effect Modelling, adjusted|||Comparing treatment effects on BMI||||0.09
72462146|NCT01614899|144447176|SUPERIORITY||LS Mean difference|-4.8||||0.05|TWO_SIDED|95.0|-9.52|0.0|||Mixed Model for Repeated Measures|||||0.00|-9.52|0.050
72462147|NCT01614899|144447176|SUPERIORITY||LS Mean difference|-4.2||||0.08|TWO_SIDED|95.0|-8.91|0.5|||Mixed Model for Repeated Measures|||||0.50|-8.91|0.080
72462148|NCT01614899|144447177|SUPERIORITY||LS Mean difference|-0.08||||0.594|TWO_SIDED|95.0|-0.354|0.203|||Mixed Model for Repeated Measures|||||0.203|-0.354|0.594
72392939|NCT00518986|144293399|SUPERIORITY_OR_OTHER|||||||0.0126||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0126
72462149|NCT01614899|144447177|SUPERIORITY||LS Mean difference|-0.18||||0.199|TWO_SIDED|95.0|-0.453|0.095|||Mixed Model for Repeated Measures|||||0.095|-0.453|0.199
72392940|NCT03366337|144293510|SUPERIORITY|A formal test of mean change from baseline in eGFR ≠ 0 was conducted at Week 12.|LS Mean change from baseline|9.31|STANDARD_ERROR_OF_MEAN|1.3743|<|0.0001|TWO_SIDED|95.0|6.5|12.13|||Mixed Models Analysis|Available data from analysis visits Week 1 to Week 12 were included. Missing data were not imputed.||||12.13|6.5|<0.0001
72462150|NCT01614899|144447178|SUPERIORITY||LS Mean difference|-1.1||||0.143|TWO_SIDED|95.0|-2.6|0.38|||Mixed Model for Repeated Measures|||||0.38|-2.60|0.143
72462151|NCT01614899|144447178|SUPERIORITY||LS Mean difference|-1.9||||0.01|TWO_SIDED|95.0|-3.4|-0.46|||Mixed Model for Repeated Measures|||||-0.46|-3.40|0.010
72462152|NCT01614899|144447179|SUPERIORITY||LS Mean difference|-1.0||||0.116|TWO_SIDED|95.0|-2.27|0.25|||Mixed Model for Repeated Measures|||||0.25|-2.27|0.116
72462153|NCT01614899|144447179|SUPERIORITY||LS Mean difference|-0.5||||0.388|TWO_SIDED|95.0|-1.8|0.7|||Mixed Model for Repeated Measures|||||0.70|-1.80|0.388
72462154|NCT01614899|144447180|SUPERIORITY||LS Mean difference|-2.5||||0.036|TWO_SIDED|95.0|-4.87|-0.17|||Mixed Model for Repeated Measures|||||-0.17|-4.87|0.036
72621100|NCT02732145|144773175|SUPERIORITY|"Question: Is there a difference in the frequency of #-#-S result (non-specific lesions) of the Inner Vulvar Ring in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology?"||||||0.8161|||||||t-test proportion|||"Parameter: The difference in the frequency of #-#-S result (non-specific lesions) of the Inner Vulvar Ring in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology."||||0.8161
72621101|NCT02732145|144773175|SUPERIORITY|"Question: Is there a difference in the frequency of #-#-P result (specific lesions) of the Inner Vulvar Ring in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology?"||||||0.1165|||||||t-test proportion|||"Parameter: The difference in the frequency of #-#-P result (specific lesions) of the Inner Vulvar Ring in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology."||||0.1165
72621102|NCT02732145|144773175|SUPERIORITY|"Question: Is there a difference in the frequency of N-N-N result (no lesions) in any of the Three Vulvar Rings in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology?"||||||0.6339|||||||t-test proportion|||"Parameter: The difference in the frequency of N-N-N result (no lesions) in any of the Three Vulvar Rings in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology."||||0.6339
72392941|NCT03366337|144293510|SUPERIORITY|A formal test of mean change from baseline in eGFR ≠ 0 was conducted at Week 12.|LS Mean change from baseline|8.0|STANDARD_ERROR_OF_MEAN|1.57|<|0.0001|TWO_SIDED|95.0|4.75|11.25|||Mixed Models Analysis|Available data from analysis visits Week 1 to Week 12 were included. Missing data were not imputed.||||11.25|4.75|<0.0001
72392942|NCT03366337|144293510|SUPERIORITY|A formal test of mean change from baseline in eGFR ≠ 0 was conducted at Week 12.|LS Mean change from baseline|5.46|STANDARD_ERROR_OF_MEAN|2.2792||0.0247|TWO_SIDED|95.0|0.76|10.16|||Mixed Models Analysis|Available data from analysis visits Week 1 to Week 12 were included. Missing data were not imputed.||||10.16|0.76|0.0247
72462155|NCT01614899|144447180|SUPERIORITY||LS Mean difference|-1.6||||0.174|TWO_SIDED|95.0|-3.93|0.72|||Mixed Model for Repeated Measures|||||0.72|-3.93|0.174
72392943|NCT03366337|144293510|SUPERIORITY|A formal test of mean change from baseline in eGFR ≠ 0 was conducted at Week 12.|LS Mean change from baseline|7.83|STANDARD_ERROR_OF_MEAN|2.216||0.003|TWO_SIDED|95.0|3.11|12.55|||Mixed Models Analysis|Available data from analysis visits Week 1 to Week 12 were included. Missing data were not imputed.||||12.55|3.11|0.0030
72392944|NCT01049308|144293518|SUPERIORITY_OR_OTHER||percentage|57.6|||||TWO_SIDED|||||||||Descriptive data to describe prevalence of cognitive impairment in outpatient veterans with chronic heart failure||||
72462156|NCT03575572|144447194|SUPERIORITY|||||||0.007|||||||Wilcoxon (Mann-Whitney)|||||||0.007
72462157|NCT03575572|144447194|SUPERIORITY|||||||0.17|||||||Wilcoxon (Mann-Whitney)|||||||0.17
72462158|NCT03575572|144447196|SUPERIORITY|||||||0.005|||||||Wilcoxon (Mann-Whitney)|||||||0.005
72462159|NCT03575572|144447196|SUPERIORITY|||||||0.13|||||||Wilcoxon (Mann-Whitney)|||||||0.13
72462160|NCT00179478|144447197|SUPERIORITY|||||||0.001||||||Based on adjusted Hazard Ratio (HR)|Regression, Cox|HR adjusted for age, onset event type, baseline brain MRI T2 lesion and number and baseline number of gad enhancing lesions||||||0.001
72462161|NCT00179478|144447198|SUPERIORITY|||||||0.02||||||a priori threshold for statistical significance was a p value less than 0.01|Wilcoxon (Mann-Whitney)|||||||0.02
72462162|NCT00179478|144447199|SUPERIORITY|||||||0.61||||||a priori threshold for statistical significance was a p value \< 0.01|Fisher Exact|||||||0.61
72462163|NCT00179478|144447200|SUPERIORITY|||||||0.5||||||a priori threshold for statistical significant was a p value less than 0.01|Fisher Exact|||||||0.50
72462164|NCT00157209|144447202|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.745||||0.045|TWO_SIDED|95.0|0.533|1.042|||Log Rank|||||1.042|0.533|0.045
72462165|NCT04281875|144447253|SUPERIORITY|||||||0.6905|||||||t-test, 2 sided|||||||0.6905
72462166|NCT00577096|144447261|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA|||||<|0.025||95.0||||Bonferroni adjusted p-value for multiple comparisons.|ANOVA|This is minus 9 (4 exercise, 5 usual care) participants who were unresponsive to Epoetin Alfa and included participants in short and long study.||The null hypothesis was that there would be no difference between groups for the number of RBC transfusions.||||<0.025
72462167|NCT00577096|144447262|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA|||||<|0.025||95.0||||Bonferroni adjusted p-value for multiple comparisons.|ANOVA|This is minus 9 (4 exercise, 5 usual care) participants who were unresponsive to Epoetin Alfa and included participants in short and long study.||The null hypothesis is that there was no difference in the number of RBC tranfusions in the exercise versus usual care groups. Data was combined from the short and long term RBC transfusions.||||<0.025
72462168|NCT00577096|144447263|NON_INFERIORITY_OR_EQUIVALENCE|T-test and chi-squared test to check for equivalence of groups for age, race and gender.|||||<|0.025||95.0||||Bonferroni adjusted p-value for multiple comparisons.|ANOVA|Analysis included short and long term participants.||||||<0.025
72462169|NCT00577096|144447264|NON_INFERIORITY_OR_EQUIVALENCE|T-test and chi-squared to check for equivalence of groups for age, race and gender.|||||<|0.025||95.0||||Bonferroni adjusted p-value for multiple comparisons.|ANOVA|This is minus 9 (4 exercise, 5 usual care) participants who were unresponsive to Epoetin Alfa and included participants in short and long study.||The null hypothesis was that there would be no difference between groups for the number of platelet transfusions.||||<0.025
72462170|NCT00577096|144447265|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA|||||<|0.025||95.0||||Bonferroni adjusted p-value for multiple comparisons.|ANOVA|This is minus 9 (4 exercise, 5 usual care) participants who were unresponsive to Epoetin Alfa and included participants in short and long study.||||||<0.025
72462171|NCT00577096|144447266|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA|||||<|0.025||95.0||||Bonferroni adjusted p-value for multiple comparisons.|ANOVA|This is minus 9 (4 exercise, 5 usual care) participants who were unresponsive to Epoetin Alfa and included participants in short and long study.||The null hypothesis was that there would be no difference between groups for the number of stem cell collection attempts.||||<0.025
72462172|NCT00577096|144447267|NON_INFERIORITY_OR_EQUIVALENCE|T-test and chi-squared to check for equivalence of groups for age, race and gender.|||||<|0.025||95.0||||Bonferroni adjusted p-value for multiple comparisons.|ANOVA|This is minus 9 (4 exercise, 5 usual care) participants who were unresponsive to Epoetin Alfa and included participants in short and long study.||The null hypothesis was that there would be no difference between groups for the number of days of stem cell collections.||||<0.025
72462173|NCT00577096|144447268|NON_INFERIORITY_OR_EQUIVALENCE|T-test and chi-squared to check for equivalence of groups for age, race and gender.|||||<|0.025||95.0||||Bonferroni adjusted p-value for multiple comparisons.|ANOVA|This is minus 9 (4 exercise, 5 usual care) participants who were unresponsive to Epoetin Alfa and included participants in short and long study.||The null hypothesis was that there would be no difference between groups for the number of days of stem cell collections.||||<0.025
72462174|NCT00577096|144447269|NON_INFERIORITY_OR_EQUIVALENCE|T-test and chi-squared to check for equivalence of groups for age, race and gender.|||||<|0.025||95.0||||Bonferroni adjusted p-value for multiple comparisons.|ANOVA|||The null hypothesis was that there would be no difference between groups for the number of platelet transfusions.||||<0.025
72462175|NCT01370564|144447271|OTHER|There was no specific hypothesis tested. The method of Rao and Scott for clustered binary data was used to construct a point estimate and 95% confidence interval for the number of days during the follow-up period across all subjects in which the patient instruction set was based on the subject's pressure state as measured by the Chronicle IHM/ICD system.|Rao-Scott estimator for clustered data|72.0|||||TWO_SIDED|95.0|65.0|78.0||||||||78|65|
72462176|NCT02181400|144447278|OTHER|||||||0.04|||||||ANCOVA|||||||0.04
72501791|NCT04321343|144533360|SUPERIORITY||Mean Difference (Final Values)|0.007|STANDARD_ERROR_OF_MEAN|0.364||0.9846|TWO_SIDED|95.0|-0.7092|0.7233|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||0.7233|-0.7092|0.9846
72462177|NCT02181400|144447279|OTHER|||||||0.04|||||||ANCOVA|||||||0.04
72462178|NCT02181400|144447280|OTHER|||||||0.12|||||||ANCOVA|||||||0.12
72563618|NCT02147587|144658364|SUPERIORITY_OR_OTHER||Difference in percentages|8.39|||||TWO_SIDED|80.0|-4.05|20.56|||80% CI based on Chan and Zhang method|||Tofacitinib versus Placebo (Day 1)||20.56|-4.05|
72462179|NCT02181400|144447281|OTHER|||||||0.32|||||||ANCOVA|||||||0.32
72462180|NCT02181400|144447282|OTHER|||||||0.02|||||||ANCOVA|||||||0.02
72462181|NCT02181400|144447283|OTHER|||||||0.49|||||||ANCOVA|||||||0.49
72462182|NCT00985621|144447284|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) Mean Difference|-0.96|STANDARD_ERROR_OF_MEAN|0.27|<|0.001|TWO_SIDED|95.0|-1.49|-0.44|||ANCOVA|||Analysis was performed using analysis of co-variance (ANCOVA) model with treatment as main effect, baseline value, index joint, previous opioid use as covariates, and study site as a random effect.||-0.44|-1.49|<0.001
72462183|NCT00985621|144447284|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.97|STANDARD_ERROR_OF_MEAN|0.27|<|0.001|TWO_SIDED|95.0|-1.5|-0.43|||ANCOVA|||Analysis was performed using analysis of co-variance (ANCOVA) model with treatment as main effect, baseline value, index joint, previous opioid use as covariates, and study site as a random effect.||-0.43|-1.50|<0.001
72462184|NCT00985621|144447285|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.97|STANDARD_ERROR_OF_MEAN|0.27|<|0.001|TWO_SIDED|95.0|-1.49|-0.45|||ANCOVA|||Analysis was performed using ANCOVA model with treatment as main effect, baseline value, index joint, previous opioid use as covariates, and study site as a random effect.||-0.45|-1.49|<0.001
72462185|NCT00985621|144447285|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.63|STANDARD_ERROR_OF_MEAN|0.27||0.018|TWO_SIDED|95.0|-1.16|-0.11|||ANCOVA|||Analysis was performed using ANCOVA model with treatment as main effect, baseline value, index joint, previous opioid use as covariates, and study site as a random effect.||-0.11|-1.16|0.018
72462186|NCT00985621|144447285|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.11|STANDARD_ERROR_OF_MEAN|0.28||0.7|TWO_SIDED|95.0|-0.43|0.65|||ANCOVA|||Analysis was performed using ANCOVA model with treatment as main effect, baseline value, index joint, previous opioid use as covariates, and study site as a random effect.||0.65|-0.43|0.700
72462187|NCT00985621|144447286|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.32|STANDARD_ERROR_OF_MEAN|0.24||0.177|TWO_SIDED|95.0|-0.78|0.14|||ANCOVA|||Change at Week 2: analysis was performed using ANCOVA model with treatment as main effect, baseline value, index joint, previous opioid use as covariates, and study site as a random effect.||0.14|-0.78|0.177
72501792|NCT04321343|144533361|SUPERIORITY||Mean Difference (Final Values)|-84.93|STANDARD_ERROR_OF_MEAN|36.75||0.0216|TWO_SIDED|95.0|-157.306|-12.558|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||-12.558|-157.306|0.0216
72501793|NCT04321343|144533361|SUPERIORITY||Mean Difference (Final Values)|-46.61|STANDARD_ERROR_OF_MEAN|35.72||0.1931|TWO_SIDED|95.0|-116.957|23.738|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||23.738|-116.957|0.1931
72563619|NCT02147587|144658364|SUPERIORITY_OR_OTHER||Difference in percentages|14.01|||||TWO_SIDED|80.0|1.57|26.03|||80% CI based on Chan and Zhang method|||Tofacitinib versus Placebo (Week 4)||26.03|1.57|
72501794|NCT04321343|144533361|SUPERIORITY||Mean Difference (Final Values)|-63.4|STANDARD_ERROR_OF_MEAN|33.31||0.0581|TWO_SIDED|95.0|-129.002|2.194|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||2.194|-129.002|0.0581
72501795|NCT04321343|144533362|SUPERIORITY||Mean Difference (Final Values)|-0.256|STANDARD_ERROR_OF_MEAN|0.153||0.0958|TWO_SIDED|95.0|-0.5577|0.0456|||Mixed Models Analysis|Mixed Models Analysis|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||0.0456|-0.5577|0.0958
72501796|NCT04321343|144533362|SUPERIORITY||Mean Difference (Final Values)|-0.273|STANDARD_ERROR_OF_MEAN|0.148||0.0659|TWO_SIDED|95.0|-0.5648|0.0181|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||0.0181|-0.5648|0.0659
72501797|NCT04321343|144533362|SUPERIORITY||Mean Difference (Final Values)|-0.301|STANDARD_ERROR_OF_MEAN|0.138||0.0297|TWO_SIDED|95.0|-0.5728|-0.03|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||-0.0300|-0.5728|0.0297
72462188|NCT00985621|144447286|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.24||0.416|TWO_SIDED|95.0|-0.66|0.28|||ANCOVA|||Change at Week 2: analysis was performed using ANCOVA model with treatment as main effect, baseline value, index joint, previous opioid use as covariates, and study site as a random effect.||0.28|-0.66|0.416
72462189|NCT00985621|144447286|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.98|STANDARD_ERROR_OF_MEAN|0.26|<|0.001|TWO_SIDED|95.0|-1.5|-0.46|||ANCOVA|||Change at Week 4: analysis was performed using ANCOVA model with treatment as main effect, baseline value, index joint, previous opioid use as covariates, and study site as a random effect.||-0.46|-1.50|<0.001
72501798|NCT04321343|144533363|SUPERIORITY||Mean Difference (Final Values)|-0.197|STANDARD_ERROR_OF_MEAN|0.175||0.2606|TWO_SIDED|95.0|-0.5423|0.1476|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||0.1476|-0.5423|0.2606
72501799|NCT04321343|144533363|SUPERIORITY||Mean Difference (Final Values)|-0.234|STANDARD_ERROR_OF_MEAN|0.17||0.1709|TWO_SIDED|95.0|-0.569|0.1016|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||0.1016|-0.5690|0.1709
72462190|NCT00985621|144447286|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.95|STANDARD_ERROR_OF_MEAN|0.27|<|0.001|TWO_SIDED|95.0|-1.48|-0.43|||ANCOVA|||Change at Week 4: analysis was performed using ANCOVA model with treatment as main effect, baseline value, index joint, previous opioid use as covariates, and study site as a random effect.||-0.43|-1.48|<0.001
72501800|NCT04321343|144533363|SUPERIORITY||Mean Difference (Final Values)|-0.321|STANDARD_ERROR_OF_MEAN|0.155||0.04|TWO_SIDED|95.0|-0.6274|-0.0148|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||-0.0148|-0.6274|0.0400
72501801|NCT04321343|144533364|SUPERIORITY||Mean Difference (Final Values)|0.011|STANDARD_ERROR_OF_MEAN|0.012||0.3955|TWO_SIDED|95.0|-0.0139|0.0351|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||0.0351|-0.0139|0.3955
72501802|NCT04321343|144533364|SUPERIORITY||Mean Difference (Final Values)|0.012|STANDARD_ERROR_OF_MEAN|0.012||0.3081|TWO_SIDED|95.0|-0.0115|0.0362|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||0.0362|-0.0115|0.3081
72501803|NCT04321343|144533364|SUPERIORITY||Mean Difference (Final Values)|0.016|STANDARD_ERROR_OF_MEAN|0.011||0.1374|TWO_SIDED|95.0|-0.0053|0.0383|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||0.0383|-0.0053|0.1374
72501804|NCT04321343|144533365|SUPERIORITY||Mean Difference (Final Values)|-48.94|STANDARD_ERROR_OF_MEAN|20.86||0.0199|TWO_SIDED|95.0|-90.073|-7.817|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||-7.817|-90.073|0.0199
72501805|NCT04321343|144533365|SUPERIORITY||Mean Difference (Final Values)|-29.77|STANDARD_ERROR_OF_MEAN|18.66||0.112|TWO_SIDED|95.0|-66.558|7.009|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||7.009|-66.558|0.1120
72501806|NCT04321343|144533365|SUPERIORITY||Mean Difference (Final Values)|-54.64|STANDARD_ERROR_OF_MEAN|17.9||0.0026|TWO_SIDED|95.0|-89.935|-19.34|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||-19.340|-89.935|0.0026
72501807|NCT04321343|144533366|SUPERIORITY||Mean Difference (Final Values)|1.674|STANDARD_ERROR_OF_MEAN|0.896||0.0639|TWO_SIDED|95.0|-0.098|3.447|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||3.4470|-0.0980|0.0639
72501808|NCT04321343|144533366|SUPERIORITY||Mean Difference (Final Values)|2.831|STANDARD_ERROR_OF_MEAN|0.867||0.0014|TWO_SIDED|95.0|1.1149|4.5464|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||4.5464|1.1149|0.0014
72501809|NCT04321343|144533366|SUPERIORITY||Mean Difference (Final Values)|4.876|STANDARD_ERROR_OF_MEAN|0.848|<|0.0001|TWO_SIDED|95.0|3.1982|6.5543|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||6.5543|3.1982|<0.0001
72501810|NCT04321343|144533367|SUPERIORITY||Mean Difference (Final Values)|1.183|STANDARD_ERROR_OF_MEAN|0.909||0.1944|TWO_SIDED|95.0|-0.608|2.9748|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||2.9748|-0.6080|0.1944
72501811|NCT04321343|144533367|SUPERIORITY||Mean Difference (Final Values)|2.459|STANDARD_ERROR_OF_MEAN|0.879||0.0056|TWO_SIDED|95.0|0.7268|4.1907|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||4.1907|0.7268|0.0056
72501812|NCT04321343|144533367|SUPERIORITY||Mean Difference (Final Values)|0.68|STANDARD_ERROR_OF_MEAN|0.858||0.4288|TWO_SIDED|95.0|-1.0111|2.372|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||2.3720|-1.0111|0.4288
72462191|NCT00985621|144447287|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.23|STANDARD_ERROR_OF_MEAN|0.23||0.319|TWO_SIDED|95.0|-0.69|0.22|||ANCOVA|||Change at Week 2: analysis was performed using ANCOVA model with treatment as main effect, baseline value, index joint, previous opioid use as covariates, and study site as a random effect.||0.22|-0.69|0.319
72462192|NCT00985621|144447287|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.02|STANDARD_ERROR_OF_MEAN|0.23||0.916|TWO_SIDED|95.0|-0.43|0.48|||ANCOVA|||Change at Week 2: analysis was performed using ANCOVA model with treatment as main effect, baseline value, index joint, previous opioid use as covariates, and study site as a random effect.||0.48|-0.43|0.916
72462193|NCT00985621|144447287|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.24||0.526|TWO_SIDED|95.0|-0.63|0.32|||ANCOVA|||Change at Week 2: analysis was performed using ANCOVA model with treatment as main effect, baseline value, index joint, previous opioid use as covariates, and study site as a random effect.||0.32|-0.63|0.526
72462194|NCT00985621|144447287|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.75|STANDARD_ERROR_OF_MEAN|0.26||0.004|TWO_SIDED|95.0|-1.26|-0.24|||ANCOVA|||Change at Week 4: analysis was performed using ANCOVA model with treatment as main effect, baseline value, index joint, previous opioid use as covariates, and study site as a random effect.||-0.24|-1.26|0.004
72462195|NCT00985621|144447287|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.39|STANDARD_ERROR_OF_MEAN|0.26||0.134|TWO_SIDED|95.0|-0.9|0.12|||ANCOVA|||Change at Week 4: analysis was performed using ANCOVA model with treatment as main effect, baseline value, index joint, previous opioid use as covariates, and study site as a random effect.||0.12|-0.90|0.134
72462196|NCT00985621|144447287|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.27||0.497|TWO_SIDED|95.0|-0.71|0.35|||ANCOVA|||Change at Week 4: analysis was performed using ANCOVA model with treatment as main effect, baseline value, index joint, previous opioid use as covariates, and study site as a random effect.||0.35|-0.71|0.497
72462197|NCT00676663|144447363|SUPERIORITY||Hazard Ratio (HR)|0.73||||0.06|TWO_SIDED|95.0|0.49|1.09|||Log Rank|P-value is stratified by the randomization stratification factors and is 1-sided, with a 0.10 threshold for significance.||||1.09|0.49|0.06
72462198|NCT00676663|144447367|SUPERIORITY||Hazard Ratio (HR)|0.59||||0.018|TWO_SIDED|95.0|0.36|0.97||P-value is stratified by the randomization stratification factors and is 1-sided.|Log Rank||Hazard ratio was estimated from a Cox proportional hazards model. Placebo serves as the reference treatment group for the interpretation of the hazard ratio.|||0.97|0.36|0.018
72462199|NCT03247985|144447370|SUPERIORITY|||||||0.17|||||||t-test, 2 sided|||Comparison between groups for bilateral operative time.||||0.17
72462200|NCT03247985|144447370|SUPERIORITY|||||||0.09|||||||t-test, 2 sided|||Comparison between groups for unilateral operative time.||||0.09
72462201|NCT03247985|144447373|SUPERIORITY|||||||0.02|||||||t-test, 2 sided|||A p-value of 0.05 was considered statistically significant.||||0.02
72462202|NCT01245699|144447376|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|||||||<0.001
72462203|NCT01245699|144447377|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|||||||<0.001
72462204|NCT01245699|144447378|SUPERIORITY|||||||0.1|||||||Kruskal-Wallis|||||||0.1
72462205|NCT01245699|144447379|SUPERIORITY|||||||0.65|||||||Kruskal-Wallis|||||||0.65
72462206|NCT01436045|144447385|SUPERIORITY_OR_OTHER||Percent Change|-15.7|STANDARD_ERROR_OF_MEAN|7.0|<|0.05|TWO_SIDED|||||RBANS Line Orientation|t-test, 2 sided||Response to intranasal Insulin Glulisine \[(result post-insulin - result post-placebo)/(result post-placebo)\] x 100%|Response to intranasal Insulin Gluiline \[(result post-insulin - result post-placebo)/(result post-placebo)\] x 100%||||<0.05
72462207|NCT01436045|144447388|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.92|STANDARD_ERROR_OF_MEAN|0.26|<|0.05|TWO_SIDED||||||t-test, 2 sided|||Difference in errors \[result post-insulin - result post-placebo\]||||<0.05
72462208|NCT00925288|144447389|NON_INFERIORITY_OR_EQUIVALENCE|Since the standard schedule is at (0, 2, 6 months), and the modified schedule at (0, 3, 6 months), we will consider this a non-inferiority study. With 80% power, type 1 error of 0.05, standard deviations of 0.6, and an equivalence margin of 0.3, 64 women are needed per group to detect non-inferiority. Having 100 women in each study arm will yield over 94% power to detect non-inferiority of the modified schedule.|||||>|0.2||95.0|||||Regression, Logistic|||The null hypothesis is that both schedules will provide an equivalent antibody response.||||>0.20
72462209|NCT00925288|144447390|SUPERIORITY_OR_OTHER|||||||0.6||95.0|||||Chi-squared|||Completion rates compared in the 2 study arms||||0.60
72462210|NCT00925288|144447391|SUPERIORITY_OR_OTHER|||||||0.53||95.0|||||Chi-squared|||comparison of differences in HPV DNA prevalence by study arm.||||0.53
72462211|NCT00635570|144447422|SUPERIORITY_OR_OTHER_LEGACY|||||||0.05|TWO_SIDED||||||Chi-squared, Corrected|Yates's chi-squared test with 1 degree of freedom was used for analysis||The trial sample size of 300 participants total (150 participants each group) was based on two-sided 5% significance testing with 80% power to detect a difference of 10% in adherence between students in the contraceptive vaginal ring group and oral contraceptive pill group.||||0.05
72462212|NCT00635570|144447423|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|TWO_SIDED|0.0|||||Chi-squared, Corrected|||||||>0.05
72462213|NCT00635570|144447424|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|||||||Chi-squared, Corrected|||||||>0.05
72462214|NCT00635570|144447425|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|||||||Chi-squared, Corrected|||||||>0.05
72462215|NCT02552810|144447438|NON_INFERIORITY_OR_EQUIVALENCE|Sample size calculation, 30 (effect size: 0.5, alpha error: 0.05, power: 0.80).|||||<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<0.05
72462216|NCT05135156|144447460|SUPERIORITY||Mean Difference (Final Values)|14.0||||0.02|TWO_SIDED|95.0|3.0|25.0|||Regression, Linear||Difference = intervention - control|||25|3|0.02
72462217|NCT05135156|144447461|SUPERIORITY||Mean Difference (Final Values)|2.8||||0.15|TWO_SIDED|95.0|-1.0|6.6|||Regression, Linear||Difference = intervention - control|||6.6|-1.0|0.15
72462218|NCT05135156|144447462|SUPERIORITY||Mean Difference (Net)|-1.2||||0.81|TWO_SIDED|95.0|-10.9|8.5|||Regression, Linear||Estimation parameter is regression parameter comparing intervention to control|||8.5|-10.9|0.81
72462219|NCT05135156|144447463|SUPERIORITY||Mean Difference (Final Values)|0.3||||0.15|TWO_SIDED|95.0|-0.1|0.8|||Regression, Linear||Difference = intervention - control|||0.8|-0.1|0.15
72462220|NCT05135156|144447464|SUPERIORITY||Mean Difference (Final Values)|0.9||||0.54|TWO_SIDED|95.0|-2.0|3.7|||Regression, Linear||Estimation parameter is regression parameter comparing intervention to control|||3.7|-2.0|0.54
72462221|NCT05135156|144447466|SUPERIORITY||Mean Difference (Final Values)|0.3||||0.82|TWO_SIDED|95.0|-2.1|2.7|||Regression, Linear||Difference = intervention - control|||2.7|-2.1|0.82
72462222|NCT05135156|144447468|SUPERIORITY||Mean Difference (Final Values)|-4.0||||0.44|TWO_SIDED|95.0|-15.0|7.0|||Regression, Linear||Estimation parameter is regression parameter comparing intervention to control|||7|-15|0.44
72563620|NCT02147587|144658364|SUPERIORITY_OR_OTHER||Difference in percentages|2.65|||||TWO_SIDED|80.0|-10.66|15.83|||80% CI based on Chan and Zhang method|||Tofacitinib versus Placebo (Week 12)||15.83|-10.66|
72563621|NCT04364763|144658369|SUPERIORITY|||||||0.0352||||||p-value is for Day 7|Mixed Models Analysis|||||||0.0352
72563622|NCT04364763|144658369|SUPERIORITY|||||||0.235||||||p-value is for Day 28|Mixed Models Analysis|||Comparison made for Day 7 and Day 28||||0.2350
72563623|NCT03420768|144658401|SUPERIORITY||Odds Ratio (OR)|1.3|||||TWO_SIDED|95.0|0.13|17.7||||||||17.70|0.13|
72563624|NCT03420768|144658401|SUPERIORITY||Odds Ratio (OR)|1.77|||||TWO_SIDED|95.0|0.26|20.23||||||||20.23|0.26|
72563625|NCT02013531|144658453|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Mixed Models Analysis|MMRM with model terms: Baseline, visit, and Baseline by visit interaction||The null hypothesis of zero in mean change from Baseline in the MADRS total score at Week 6 was tested at a significance level of 0.05. Because this was an exploratory trial, no methods to control type I error rate were performed.||||<0.0001
72563626|NCT02013531|144658454|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Mixed Models Analysis|Mixed model repeated measure (MMRM) with model terms: Baseline, visit, and Baseline by visit interaction||Statistical analysis at Week 6.||||<0.0001
72563627|NCT02013531|144658460|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Mixed Models Analysis|Mixed model repeated measure (MMRM) with model terms: Baseline, visit, and Baseline by visit interaction||The null hypothesis of zero in Mean change from Baseline in HAM-A total score at Week 6 was tested at a significance level of 0.05. Because this was an exploratory trial, no methods to control type I error rate were performed.||||<0.0001
72621103|NCT02732145|144773175|SUPERIORITY|"Question: Is there a difference in the frequency of S result (non-specific lesions) in any of the Three Vulvar Rings (S-#-#; S-S-#; S-S-S; S-N-S etc.) in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology?"||||||0.9724|||||||t-test proportion|||"Parameter: The difference in the frequency of S result (non-specific lesions) in any of the Three Vulvar Rings (S-#-#; S-S-#; S-S-S; S-N-S etc.) in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology."||||0.9724
72462223|NCT05135156|144447469|SUPERIORITY||Mean Difference (Net)|1.3||||0.31|TWO_SIDED|95.0|-1.3|3.9|||Regression, Linear||Estimation parameter is regression parameter comparing intervention to control|||3.9|-1.3|0.31
72462224|NCT05135156|144447470|SUPERIORITY||Mean Difference (Net)|5.0||||0.42|TWO_SIDED|95.0|-7.4|17.4|||Regression, Linear||Difference = intervention - control||Estimation parameter is regression parameter comparing intervention to control|17.4|-7.4|0.42
72462225|NCT05135156|144447471|OTHER|Pearson's chi-squared test of independence||||||0.39||||||p=0.39 at baseline, 0.39 at 2 weeks and 0.23 at 4 weeks|Chi-squared|||||||0.39
72462226|NCT05135156|144447472|SUPERIORITY||Mean Difference (Net)|0.05||||0.91|TWO_SIDED|95.0|-0.84|0.94|||Regression, Linear||Parameters are for a 60-minute greater amount of time spent on the website (range was 21-418 minutes in the first 2 weeks).|Outcome = change in confidence-weighted true false knowledge about lung transplant (14-question investigator-designed survey) from baseline to 2-week study visit||0.94|-0.84|0.91
72462227|NCT05135156|144447472|SUPERIORITY||Mean Difference (Net)|0.04||||0.53|TWO_SIDED|95.0|-0.08|0.16|||Regression, Linear||Parameters are for a 60-minute greater amount of time spent on the website (range was 21-418 minutes in the first 2 weeks).|Outcome = change in Likert preparedness to discuss transplant from baseline to 2-week study visit||0.16|-0.08|0.53
72462228|NCT05135156|144447472|SUPERIORITY||Mean Difference (Net)|-4.3||||0.04|TWO_SIDED|95.0|-8.4|-0.3|||Regression, Linear||Parameters are for a 60-minute greater amount of time spent on the website (range was 21-418 minutes in the first 2 weeks).|Outcome = change in Decisional Conflict Scale from baseline to 2-week study visit||-0.3|-8.4|0.04
72462229|NCT05135156|144447472|SUPERIORITY||Mean Difference (Final Values)|0.7||||0.74|TWO_SIDED|95.0|-3.6|5.0||Outcome = mean PrepDM Scale at 2-weeks|Regression, Linear||Parameters are for a 60-minute greater amount of time spent on the website (range was 21-418 minutes in the first 2 weeks).|||5.0|-3.6|0.74
72462230|NCT01284634|144447519|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.89|STANDARD_ERROR_OF_MEAN|5.454||0.222|TWO_SIDED|90.0|-16.35|2.56|||Regression, Linear|||The EOT liver triglyceride levels were analyzed using a linear regression model, with EOT liver triglyceride levels as the dependent variable, dose of GWP42003 as regressor, baseline liver triglyceride levels as a covariate, and gender as a factor.||2.56|-16.35|0.222
72462231|NCT01284634|144447519|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.35|STANDARD_ERROR_OF_MEAN|5.943||0.133|TWO_SIDED|90.0|-19.66|0.95|||Regression, Linear|||The EOT liver triglyceride levels were analyzed using a linear regression model, with EOT liver triglyceride levels as the dependent variable, dose of GWP42003 as regressor, baseline liver triglyceride levels as a covariate, and gender as a factor.||0.95|-19.66|0.133
72462232|NCT01284634|144447519|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.54|STANDARD_ERROR_OF_MEAN|6.158||0.302|TWO_SIDED|90.0|-17.22|4.14|||Regression, Linear|||The EOT liver triglyceride levels were analyzed using a linear regression model, with EOT liver triglyceride levels as the dependent variable, dose of GWP42003 as regressor, baseline liver triglyceride levels as a covariate, and gender as a factor.||4.14|-17.22|0.302
72462233|NCT02720081|144447530|SUPERIORITY||Difference in least squares means|-4.775||||0.352|TWO_SIDED|95.0|-14.92|5.37|||ANOVA|Terms for treatment, number of C alleles at the pre-specified SNP, and prior inhaled corticosteroid use.||||5.370|-14.92|0.352
72462234|NCT02720081|144447531|OTHER||Difference in percentages|-0.4|||||TWO_SIDED|95.0|-15.0|14.3|||||Based on Miettinen \& Nurminen|||14.3|-15.0|
72462235|NCT02720081|144447532|OTHER||Difference in percentages|-4.3|||||TWO_SIDED|95.0|-12.1|1.0|||||Based on Miettinen \& Nurminen|||1.0|-12.1|
72462236|NCT02720081|144447554|SUPERIORITY||Difference in least squares means|0.107||||0.023|TWO_SIDED|95.0|0.015|0.199|||Constrained longitudinal data analysis|Terms for treatment, time, interaction of time by treatment, number of C alleles at the pre-specified SNP, and prior inhaled corticosteroid use.||||0.199|0.015|0.023
72462237|NCT03334747|144447576|OTHER|||||||0.391|||||||Fisher Exact|2-sided p-value results from Fisher exact test for each KAE609 treatment group compared to Pooled Coartem||||||0.391
72462238|NCT03334747|144447576|OTHER|||||||1|||||||Fisher Exact|2-sided p-value results from Fisher exact test for each KAE609 treatment group compared to Pooled Coartem||||||1
72462239|NCT03334747|144447576|OTHER|||||||1|||||||Fisher Exact|2-sided p-value results from Fisher exact test for each KAE609 treatment group compared to Pooled Coartem||||||1
72462240|NCT03334747|144447576|OTHER|||||||1|||||||Fisher Exact|2-sided p-value results from Fisher exact test for each KAE609 treatment group compared to Pooled Coartem||||||1
72462241|NCT03334747|144447576|OTHER|||||||1|||||||Fisher Exact|2-sided p-value results from Fisher exact test for each KAE609 treatment group compared to Pooled Coartem||||||1
72462242|NCT03334747|144447576|OTHER|||||||1|||||||Fisher Exact|2-sided p-value results from Fisher exact test for each KAE609 treatment group compared to Pooled Coartem||||||1
72462243|NCT03334747|144447576|OTHER|||||||1|||||||Fisher Exact|2-sided p-value results from Fisher exact test for each KAE609 treatment group compared to Pooled Coartem||||||1
72462244|NCT03334747|144447576|OTHER|||||||1|||||||Fisher Exact|2-sided p-value results from Fisher exact test for each KAE609 treatment group compared to Pooled Coartem||||||1
72462245|NCT02567227|144447585|SUPERIORITY||Mean Difference (Net)|-1.03|STANDARD_ERROR_OF_MEAN|1.3|||TWO_SIDED|95.0|-3.6|1.54|||||Estimates with standard errors are from linear mixed effect models adjusted for age, sex, education years, comorbidities, pain, cardiac fitness, and cognitive status.|Linear mixed effects model adjusted for age, sex, education (school years), comorbidities score (0-10), pain, Duke score (cardiac fitness), and cognitive status (Mild Cognitive Impairment (MCI) or cognitively normal) were used to compare changes in speed during normal pace walking pre and post intervention.||1.54|-3.60|
72462246|NCT02567227|144447585|SUPERIORITY||Mean Difference (Net)|0.59|STANDARD_ERROR_OF_MEAN|1.61|||TWO_SIDED|95.0|-2.59|3.76||P-values from linear mixed effects models adjusted for age, sex, education years, comorbidities, pain, cardiac fitness, and cognitive status|||Estimates with standard errors are from linear mixed effect models adjusted for age, sex, education years, comorbidities, pain, cardiac fitness, and cognitive status.|Linear mixed effects model adjusted for age, sex, education (school years), comorbidities score (0-10), pain, Duke score (cardiac fitness), and cognitive status (MCI or cognitively normal) were used to compare changes in speed during walking while talking pre and post intervention.||3.76|-2.59|
72462247|NCT02567227|144447586|SUPERIORITY||Mean Difference (Net)|-0.15|STANDARD_ERROR_OF_MEAN|0.17|||TWO_SIDED|95.0|-0.49|0.2|||||Estimates with standard errors are from linear mixed effect models adjusted for age, sex, education years, comorbidities, pain, cardiac fitness, and cognitive status.|Linear mixed effects model adjusted for age, sex, education (school years), comorbidities score (0-10), pain, Duke score (cardiac fitness), and cognitive status (MCI or cognitively normal) were used to compare changes in SPPB scores pre and post intervention.||0.20|-0.49|
72462248|NCT02567227|144447587|SUPERIORITY||Mean Difference (Net)|0.83|STANDARD_ERROR_OF_MEAN|1.5|||TWO_SIDED|95.0|-2.13|3.79|||||Estimates with standard errors are from linear mixed effect models adjusted for age, sex, education years, comorbidities, pain, cardiac fitness, and cognitive status.|Linear mixed effects model adjusted for age, sex, education (school years), comorbidities score (0-10), pain, Duke score (cardiac fitness), and cognitive status (MCI or cognitively normal) were used to compare changes in stride length during walking while talking pre and post intervention.||3.79|-2.13|
72462249|NCT02567227|144447587|SUPERIORITY||Mean Difference (Net)|-1.95|STANDARD_ERROR_OF_MEAN|1.04|||TWO_SIDED||||||||Estimates with standard errors are from linear mixed effect models.|Unadjusted linear mixed effects models were used to compare changes in stride length during normal walking pre and post intervention.||||
72501813|NCT04321343|144533368|SUPERIORITY||Mean Difference (Final Values)|-1.251|STANDARD_ERROR_OF_MEAN|1.093||0.2564|TWO_SIDED|95.0|-3.4307|0.9295|||Regression, Linear||Mean difference (final values) is the difference in LS Means estimated in the linear regression.|||0.9295|-3.4307|0.2564
72462250|NCT02567227|144447588|SUPERIORITY||Mean Difference (Net)|-0.24|STANDARD_ERROR_OF_MEAN|0.34|||TWO_SIDED|95.0|-0.91|0.43|||||Estimates with standard errors are from linear mixed effect models adjusted for age, sex, education years, comorbidities, pain, cardiac fitness, and cognitive status.|Linear mixed effects model adjusted for age, sex, education (school years), comorbidities score (0-10), pain, Duke score (cardiac fitness), and cognitive status (MCI or cognitively normal) were used to compare changes in stride length variability during normal walking pre and post intervention.||0.43|-0.91|
72462251|NCT02567227|144447588|SUPERIORITY||Mean Difference (Net)|-0.44|STANDARD_ERROR_OF_MEAN|0.36|||TWO_SIDED|95.0|-1.16|0.27|||||Estimates with standard errors are from linear mixed effect models adjusted for age, sex, education years, comorbidities, pain, cardiac fitness, and cognitive status.|Linear mixed effects model adjusted for age, sex, education (school years), comorbidities score (0-10), pain, Duke score (cardiac fitness), and cognitive status (MCI or cognitively normal) were used to compare changes in stride length variability during walking while talking pre and post intervention.||0.27|-1.16|
72462252|NCT02567227|144447589|SUPERIORITY||Mean Difference (Net)|-0.16|||||TWO_SIDED|95.0|-0.51|0.19|||||Estimates with standard errors are from linear mixed effect models adjusted for age, sex, education years, comorbidities, pain, cardiac fitness, and cognitive status.|Linear mixed effects model adjusted for age, sex, education (school years), comorbidities score (0-10), pain, Duke score (cardiac fitness), and cognitive status (MCI or cognitively normal) were used to compare changes in the pace domain during normal pace walking pre and post intervention.||0.19|-0.51|
72462253|NCT02567227|144447589|SUPERIORITY||Mean Difference (Net)|0.1|||||TWO_SIDED|95.0|-0.2|0.41|||||Estimates with standard errors are from linear mixed effect models adjusted for age, sex, education years, comorbidities, pain, cardiac fitness, and cognitive status.|Linear mixed effects model adjusted for age, sex, education (school years), comorbidities score (0-10), pain, Duke score (cardiac fitness), and cognitive status (MCI or cognitively normal) were used to compare changes in the rhythm domain during normal pace walking pre and post intervention.||0.41|-0.20|
72501814|NCT04321343|144533368|SUPERIORITY||Mean Difference (Final Values)|-1.598|STANDARD_ERROR_OF_MEAN|1.021||0.1222|TWO_SIDED|95.0|-3.6348|0.4392|||Regression, Linear||Mean difference (final values) is the difference in LS Means estimated in the linear regression.|||0.4392|-3.6348|0.1222
72501815|NCT04321343|144533368|SUPERIORITY||Mean Difference (Final Values)|-2.22|STANDARD_ERROR_OF_MEAN|0.936||0.0206|TWO_SIDED|95.0|-4.088|-0.351|||Regression, Linear||Mean difference (final values) is the difference in LS Means estimated in the linear regression.|||-0.3510|-4.0880|0.0206
72501816|NCT04321343|144533369|SUPERIORITY||Odds Ratio (OR)|1.51||||0.5221|TWO_SIDED|95.0|0.436|5.201|||Cochran-Mantel-Haenszel|||||5.201|0.436|0.5221
72462254|NCT02567227|144447589|SUPERIORITY||Mean Difference (Net)|-0.11|||||TWO_SIDED|95.0|-0.53|0.32|||||Estimates with standard errors are from linear mixed effect models adjusted for age, sex, education years, comorbidities, pain, cardiac fitness, and cognitive status.|Linear mixed effects model adjusted for age, sex, education (school years), comorbidities score (0-10), pain, Duke score (cardiac fitness), and cognitive status (MCI or cognitively normal) were used to compare changes in the variation domain during normal pace walking pre and post intervention.||0.32|-0.53|
72462255|NCT02567227|144447589|SUPERIORITY||Mean Difference (Net)|0.14|||||TWO_SIDED|95.0|-0.27|0.56|||||Estimates with standard errors are from linear mixed effect models adjusted for age, sex, education years, comorbidities, pain, cardiac fitness, and cognitive status.|Linear mixed effects model adjusted for age, sex, education (school years), comorbidities score (0-10), pain, Duke score (cardiac fitness), and cognitive status (MCI or cognitively normal) were used to compare changes in the pace domain during walking while talking pre and post intervention.||0.56|-0.27|
72462256|NCT02567227|144447589|SUPERIORITY||Mean Difference (Net)|-0.02|||||TWO_SIDED|95.0|-0.48|0.45|||||Estimates with standard errors are from linear mixed effect models adjusted for age, sex, education years, comorbidities, pain, cardiac fitness, and cognitive status.|Linear mixed effects model adjusted for age, sex, education (school years), comorbidities score (0-10), pain, Duke score (cardiac fitness), and cognitive status (MCI or cognitively normal) were used to compare changes in the rhythm domain during walking while talking pre and post intervention.||0.45|-0.48|
72462257|NCT02567227|144447589|SUPERIORITY||Mean Difference (Net)|-0.02|||||TWO_SIDED|95.0|-0.4|0.35|||||Estimates with standard errors are from linear mixed effect models adjusted for age, sex, education years, comorbidities, pain, cardiac fitness, and cognitive status.|Linear mixed effects model adjusted for age, sex, education (school years), comorbidities score (0-10), pain, Duke score (cardiac fitness), and cognitive status (MCI or cognitively normal) were used to compare changes in the variation domain during walking while talking pre and post intervention.||0.35|-0.40|
72462258|NCT02567227|144447590|SUPERIORITY||Odds Ratio (OR)|0.925|||||TWO_SIDED|95.0|0.369|2.319||||||Logistic model for treatment effect on substantial improvement in normal velocity adjusted for age, sex, education (school years), comorbidities score (0-10), pain, Duke score (cardiac fitness), and cognitive status (MCI or cognitively normal).||2.319|0.369|
72462259|NCT02567227|144447590|SUPERIORITY||Odds Ratio (OR)|0.961|||||TWO_SIDED|95.0|0.516|1.789||||||Logistic model for treatment effect on substantial improvement in walking while talking velocity adjusted for age, sex, education (school years), comorbidities score (0-10), pain, Duke score (cardiac fitness), and cognitive status (MCI or cognitively normal).||1.789|0.516|
72501817|NCT04321343|144533369|SUPERIORITY||Odds Ratio (OR)|1.62||||0.4828|TWO_SIDED|95.0|0.434|6.012|||Cochran-Mantel-Haenszel|||||6.012|0.434|0.4828
72501818|NCT04321343|144533369|SUPERIORITY||Odds Ratio (OR)|2.87||||0.0914|TWO_SIDED|95.0|0.853|9.636|||Cochran-Mantel-Haenszel|||||9.636|0.853|0.0914
72462260|NCT02567227|144447591|SUPERIORITY||Mean Difference (Net)|-7.52|STANDARD_ERROR_OF_MEAN|14.17|||TWO_SIDED|95.0|-35.45|20.41|||||Estimates with standard errors are from linear mixed effect models adjusted for age, sex, education years, comorbidities, pain, cardiac fitness, and cognitive status.|Linear mixed effects model adjusted for age, sex, education (school years), comorbidities score (0-10), pain, Duke score (cardiac fitness), and cognitive status (MCI or cognitively normal) were used to compare changes in Flanker performance (milliseconds) pre and post intervention.||20.41|-35.45|
72462261|NCT02567227|144447592|SUPERIORITY||Mean Difference (Net)|1.01|STANDARD_ERROR_OF_MEAN|0.66|||TWO_SIDED|95.0|-0.3|2.31|||||Estimates with standard errors are from linear mixed effect models adjusted for age, sex, education years, comorbidities, pain, cardiac fitness, and cognitive status.|Linear mixed effects model adjusted for age, sex, education (school years), comorbidities score (0-10), pain, Duke score (cardiac fitness), and cognitive status (MCI or cognitively normal) were used to compare changes on the Digit Symbol Substitution Test pre and post intervention.||2.31|-0.30|
72462262|NCT02567227|144447593|SUPERIORITY||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|0.03|||TWO_SIDED||||||||Estimates with standard errors are from unadjusted linear mixed effect models.|Unadjusted linear mixed effects model was used to compare performance on Trail Making Test form A pre and post intervention.||||
72462263|NCT02567227|144447594|SUPERIORITY||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|0.03|||TWO_SIDED|95.0|-0.07|0.06|||||Estimates with standard errors are from linear mixed effect models adjusted for age, sex, education years, comorbidities, pain, cardiac fitness, and cognitive status.|Linear mixed effects model adjusted for age, sex, education (school years), comorbidities score (0-10), pain, Duke score (cardiac fitness), and cognitive status (MCI or cognitively normal) were used to compare changes in performance on Trail Making Test form B pre and post intervention.||0.06|-0.07|
72501819|NCT04321343|144533370|SUPERIORITY||Odds Ratio (OR)|2.71||||0.1854|TWO_SIDED|95.0|0.628|11.679|||Cochran-Mantel-Haenszel|||||11.679|0.628|0.1854
72501820|NCT04321343|144533370|SUPERIORITY||Odds Ratio (OR)|4.11||||0.0562|TWO_SIDED|95.0|0.959|17.594|||Cochran-Mantel-Haenszel|||||17.594|0.959|0.0562
72501821|NCT04321343|144533370|SUPERIORITY||Odds Ratio (OR)|1.53||||0.5223|TWO_SIDED|95.0|0.398|5.88|||Cochran-Mantel-Haenszel|||||5.880|0.398|0.5223
72501822|NCT04321343|144533371|SUPERIORITY||Mean Difference (Final Values)|0.28|STANDARD_ERROR_OF_MEAN|0.891||0.7532|TWO_SIDED|95.0|-1.4749|2.0356|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||2.0356|-1.4749|0.7532
72501823|NCT04321343|144533371|SUPERIORITY||Mean Difference (Final Values)|1.985|STANDARD_ERROR_OF_MEAN|0.858||0.0216|TWO_SIDED|95.0|0.2946|3.6763|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||3.6763|0.2946|0.0216
72501824|NCT04321343|144533371|SUPERIORITY||Mean Difference (Final Values)|0.224|STANDARD_ERROR_OF_MEAN|0.838||0.7893|TWO_SIDED|95.0|-1.4283|1.8771|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||1.8771|-1.4283|0.7893
72501825|NCT04194944|144533372|SUPERIORITY||Hazard Ratio (HR)|0.465||||0.0002|TWO_SIDED|95.0|0.309|0.699|||Log Rank|||||0.699|0.309|0.0002
72501826|NCT04194944|144533373|SUPERIORITY||Hazard Ratio (HR)|0.482||||0.0001|TWO_SIDED|95.0|0.331|0.7|||Log Rank|||||0.700|0.331|0.0001
72621104|NCT02732145|144773175|SUPERIORITY|"Question: Is there a difference in the frequency of P result (specific lesions) in any of the Three Vulvar Rings (P-#-#; P-P-; P-P-P; P-N-S etc.) in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology?"||||||0.0016|||||||t-test proportion|||"Parameter: The difference in the frequency of P result (specific lesions) in any of the Three Vulvar Rings (P-#-#; P-P-; P-P-P; P-N-S etc.) in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology."||||0.0016
72621105|NCT02732145|144773176|EQUIVALENCE|Question: Is there a difference in the age of patients from different groups?||||||0|||||||ANOVA|||Parameter: The difference in the age of patients from different groups.||||0.0000
72621106|NCT02732145|144773177|EQUIVALENCE|Is there a difference in the weight of patients from different groups?||||||0|||||||ANOVA|||The difference in the weight of patients from different groups.||||0.0000
72462264|NCT02567227|144447595|SUPERIORITY||Mean Difference (Net)|0.67|STANDARD_ERROR_OF_MEAN|0.78|||TWO_SIDED|95.0|-0.86|2.2|||||Estimates with standard errors are from linear mixed effect models adjusted for age, sex, education years, comorbidities, pain, cardiac fitness, and cognitive status.|Linear mixed effects model adjusted for age, sex, education (school years), comorbidities score (0-10), pain, Duke score (cardiac fitness), and cognitive status (MCI or cognitively normal) were used to compare changes performance on the Controlled Oral Word Association Test pre and post intervention.||2.20|-0.86|
72462265|NCT02567227|144447598|SUPERIORITY||Mean Difference (Net)|1.13|STANDARD_ERROR_OF_MEAN|1.42|||TWO_SIDED|95.0|-1.65|3.91|||||Estimates with standard errors are from linear mixed effect models adjusted for age, sex, education years, comorbidities, pain, cardiac fitness, and cognitive status.|Linear mixed effects model adjusted for age, sex, education (school years), comorbidities score (0-10), pain, Duke score (cardiac fitness), and cognitive status (MCI or cognitively normal) were used to compare changes in gait speed during normal walking pre and 6 months post intervention.||3.91|-1.65|
72462266|NCT02567227|144447598|SUPERIORITY||Mean Difference (Net)|1.4|STANDARD_ERROR_OF_MEAN|1.79|||TWO_SIDED|95.0|-2.12|4.91|||||Estimates with standard errors are from linear mixed effect models adjusted for age, sex, education years, comorbidities, pain, cardiac fitness, and cognitive status.|Linear mixed effects model adjusted for age, sex, education (school years), comorbidities score (0-10), pain, Duke score (cardiac fitness), and cognitive status (MCI or cognitively normal) were used to compare changes in gait speed during walking while talking pre and 6 months post intervention.||4.91|-2.12|
72462267|NCT02567227|144447599|SUPERIORITY||Mean Difference (Net)|-0.03|STANDARD_ERROR_OF_MEAN|0.04|||TWO_SIDED||||||||Estimates with standard errors are from unadjusted linear mixed effect models.|Unadjusted linear mixed effects model was used to compare changes in stair climbing time pre and post intervention.||||
72462268|NCT02567227|144447600|SUPERIORITY||Mean Difference (Final Values)|0.03|STANDARD_ERROR_OF_MEAN|0.32|||TWO_SIDED||||||||Estimates with standard errors are from unadjusted linear mixed effect models.|Unadjusted linear mixed effects model was used to compare changes in activities of daily living pre and post intervention.||||
72501827|NCT04194944|144533374|SUPERIORITY||Odds Ratio (OR)|1.5||||0.3996|TWO_SIDED|95.0|0.7|3.4|||Cochran-Mantel-Haenszel|||||3.4|0.7|0.3996
72501828|NCT04194944|144533375|SUPERIORITY||Odds Ratio (OR)|1.7||||0.139|TWO_SIDED|95.0|0.9|3.6|||Cochran-Mantel-Haenszel|||||3.6|0.9|0.1390
72501829|NCT04194944|144533378|SUPERIORITY||Odds Ratio (OR)|2.7||||0.0028|TWO_SIDED|95.0|1.4|5.1|||Cochran-Mantel-Haenszel|||||5.1|1.4|0.0028
72501830|NCT04194944|144533379|SUPERIORITY||Odds Ratio (OR)|2.9||||0.0003|TWO_SIDED|95.0|1.6|5.2|||Cochran-Mantel-Haenszel|||||5.2|1.6|0.0003
72501831|NCT04194944|144533380|SUPERIORITY||Hazard Ratio (HR)|0.377||||0.0001|TWO_SIDED|95.0|0.224|0.633|||Log Rank|||||0.633|0.224|0.0001
72501832|NCT04194944|144533381|SUPERIORITY||Hazard Ratio (HR)|0.418||||0.0004|TWO_SIDED|95.0|0.256|0.684|||Log Rank|||||0.684|0.256|0.0004
72501833|NCT04194944|144533384|SUPERIORITY||Odds Ratio (OR)|3.2||||0.1809|TWO_SIDED|95.0|0.8|12.8|||Cochran-Mantel-Haenszel|||||12.8|0.8|0.1809
72501834|NCT04194944|144533385|SUPERIORITY||Odds Ratio (OR)|5.2||||0.0167|TWO_SIDED|95.0|1.4|19.6|||Cochran-Mantel-Haenszel|||||19.6|1.4|0.0167
72501835|NCT00473694|144533412|SUPERIORITY||Estimated Treatment Effect|17.29|||<|0.0001|TWO_SIDED|95.0|13.95|21.42||A two-way ANOVA model was used with the logarithm of the recovery time taken as the response variable, and trial site and treatment group were the factors of the model.|ANOVA||The value for estimated treatment effect represents how many times faster the mean time to recovery of the T4/T1 ratio to 0.9 was for participants receiving sugammadex after NMB compared to participants receiving neostigmine after NMB.|||21.42|13.95|<0.0001
72501836|NCT00473694|144533413|SUPERIORITY||Estimated Treatment Effect|14.86|||<|0.0001|TWO_SIDED|95.0|10.18|21.67||A two-way ANOVA model was used with the logarithm of the recovery time taken as the response variable, and trial site and treatment group were the factors of the model.|ANOVA||The value for estimated treatment effect represents how many times faster the mean time to recovery of the T4/T1 ratio to 0.9 was for participants receiving sugammadex after NMB compared to participants receiving neostigmine after NMB.|||21.67|10.18|<0.0001
72501837|NCT00473694|144533414|SUPERIORITY||Estimated Treatment Effect|15.84|||<|0.0001|TWO_SIDED|95.0|12.58|19.95||A two-way ANOVA model was used with the logarithm of the recovery time taken as the response variable, and trial site and treatment group were the factors of the model.|ANOVA||The value for estimated treatment effect represents how many times faster the mean time to recovery of the T4/T1 ratio to 0.7 was for participants receiving sugammadex after NMB compared to participants receiving neostigmine after NMB.|||19.95|12.58|<0.0001
72501838|NCT00473694|144533415|SUPERIORITY||Estimated Treatment Effect|18.45|||<|0.0001|TWO_SIDED|95.0|13.98|24.35||A two-way ANOVA model was used with the logarithm of the recovery time taken as the response variable, and trial site and treatment group were the factors of the model.|ANOVA||The value for estimated treatment effect represents how many times faster the mean time to recovery of the T4/T1 ratio to 0.7 was for participants receiving sugammadex after NMB compared to participants receiving neostigmine after NMB.|||24.35|13.98|<0.0001
72462269|NCT02567227|144447601|SUPERIORITY||Mean Difference (Net)|0.26|STANDARD_ERROR_OF_MEAN|0.34|||TWO_SIDED|95.0|-0.4|0.93|||||Estimates with standard errors are from linear mixed effect models adjusted for age, sex, education years, comorbidities, pain, cardiac fitness, and cognitive status.|Linear mixed effects model adjusted for age, sex, education (school years), comorbidities score (0-10), pain, Duke score (cardiac fitness), and cognitive status (MCI or cognitively normal) were used to compare changes in depressive symptoms measured using the GDS pre and post intervention.||0.93|-0.40|
72462270|NCT02567227|144447603|SUPERIORITY||Mean Difference (Net)|0.39|STANDARD_ERROR_OF_MEAN|0.9|||TWO_SIDED|95.0|-1.38|2.16|||||Estimates with standard errors are from linear mixed effect models adjusted for age, sex, education years, comorbidities, pain, cardiac fitness, and cognitive status.|Linear mixed effects model adjusted for age, sex, education (school years), comorbidities score (0-10), pain, Duke score (cardiac fitness), and cognitive status (MCI or cognitively normal) were used to compare changes in reported fear of falling measured on the Falls Efficacy Scale pre and post intervention.||2.16|-1.38|
72462271|NCT02567227|144447604|SUPERIORITY||Mean Difference (Final Values)|-0.21|STANDARD_ERROR_OF_MEAN|0.64|||TWO_SIDED|95.0|-1.46|1.04|||||Estimates with standard errors are from linear mixed effect models adjusted for age, sex, education years, comorbidities, pain, cardiac fitness, and cognitive status.|Linear mixed effects model adjusted for age, sex, education (school years), comorbidities score (0-10), pain, Duke score (cardiac fitness), and cognitive status (MCI or cognitively normal) were used to compare changes in the physical health score of the SF-12 pre and post intervention.||1.04|-1.46|
72462272|NCT02567227|144447604|SUPERIORITY||Mean Difference (Final Values)|0.41|STANDARD_ERROR_OF_MEAN|0.73|||TWO_SIDED|95.0|-1.04|1.85|||||Estimates with standard errors are from linear mixed effect models adjusted for age, sex, education years, comorbidities, pain, cardiac fitness, and cognitive status.|Linear mixed effects model adjusted for age, sex, education (school years), comorbidities score (0-10), pain, Duke score (cardiac fitness), and cognitive status (MCI or cognitively normal) were used to compare changes in the mental health score of the SF-12 pre and post intervention.||1.85|-1.04|
72462273|NCT04748445|144447610|OTHER||Slope|0.065|||<|0.0001|TWO_SIDED|90.0|0.046|0.083|||Mixed Models Analysis|||Chills||0.083|0.046|<.0001
72462274|NCT04748445|144447610|OTHER||Slope|0.281|||<|0.0001|TWO_SIDED|90.0|0.221|0.341|||Mixed Models Analysis|||Cough||0.341|0.221|<.0001
72462275|NCT04748445|144447610|OTHER||Slope|0.036|||<|0.0001|TWO_SIDED|90.0|0.023|0.048|||Mixed Models Analysis|||Diarrhea||0.048|0.023|<.0001
72462276|NCT04748445|144447610|OTHER||Slope|0.113|||<|0.0001|TWO_SIDED|90.0|0.069|0.156|||Mixed Models Analysis|||Difficulty breathing||0.156|0.069|<.0001
72462277|NCT04748445|144447610|OTHER||Slope|0.259|||<|0.0001|TWO_SIDED|90.0|0.206|0.312|||Mixed Models Analysis|||Fatigue||0.312|0.206|<.0001
72563628|NCT03396874|144658476|SUPERIORITY|Exact binomial proportion test, R statistical software package: R version 4.3.1 (2023-06-16)|PPV|87.3|||<|1e-07|TWO_SIDED|95.0|81.58|100.0||The exact p-value cannot be entered as it is equal to 2.2e-16.|Exact binomial proportion test|Exact binomial proportion test, R statistical software package: R version 4.3.1 (2023-06-16)||We determined the positive predictive value (PPV) (true positives / (true positives + false positives)) of 68Ga-PSMA-11 PET for presence or absence of prostate cancer confirmed by histopathology on a per-patient basis. On a per-patient basis, the PPV of conventional imaging ranges between 30-50%. The null hypothesis is that the PPV at 50% will be tested against the alternative hypothesis that the PPV is greater than 50%.||100.00|81.58|<0.0000001
72462278|NCT04748445|144447610|OTHER||Slope|0.029|||<|0.0001|TWO_SIDED|90.0|0.02|0.037|||Mixed Models Analysis|||Fever||0.037|0.020|<.0001
72462279|NCT04748445|144447610|OTHER||Slope|0.194|||<|0.0001|TWO_SIDED|90.0|0.148|0.241|||Mixed Models Analysis|||Headache||0.241|0.148|<.0001
72462280|NCT04748445|144447610|OTHER||Slope|0.103||||0.0002|TWO_SIDED|90.0|0.059|0.148|||Mixed Models Analysis|||Loss of taste or smell||0.148|0.059|0.0002
72621107|NCT02732145|144773178|EQUIVALENCE|Is there a difference in the height of patients from different groups.||||||0.0557|||||||ANOVA|||The difference in the height of patients from different groups.||||0.0557
72462281|NCT04748445|144447610|OTHER||Slope|0.181|||<|0.0001|TWO_SIDED|90.0|0.137|0.226|||Mixed Models Analysis|||Muscle pain||0.226|0.137|<.0001
72462282|NCT04748445|144447610|OTHER||Slope|0.044|||<|0.0001|TWO_SIDED|90.0|0.028|0.06|||Mixed Models Analysis|||Nausea||0.060|0.028|<.0001
72462283|NCT04748445|144447610|OTHER||Slope|0.03||||0.0007|TWO_SIDED|90.0|0.016|0.044|||Mixed Models Analysis|||Rigors||0.044|0.016|0.0007
72462284|NCT04748445|144447610|OTHER||Slope|0.159|||<|0.0001|TWO_SIDED|90.0|0.123|0.195|||Mixed Models Analysis|||Runny nose||0.195|0.123|<.0001
72462285|NCT04748445|144447610|OTHER||Slope|0.222|||<|0.0001|TWO_SIDED|90.0|0.168|0.277|||Mixed Models Analysis|||Sore throat||0.277|0.168|<.0001
72462286|NCT04748445|144447610|OTHER||Slope|0.337|||<|0.0001|TWO_SIDED|90.0|0.264|0.411|||Mixed Models Analysis|||Stuffy/blocked nose||0.411|0.264|<.0001
72462287|NCT04748445|144447610|OTHER||Slope|0.005||||0.0053|TWO_SIDED|90.0|0.002|0.007|||Mixed Models Analysis|||Vomiting||0.007|0.002|0.0053
72462288|NCT04748445|144447610|OTHER||Slope|0.049||||0.0057|TWO_SIDED|90.0|0.02|0.078|||Mixed Models Analysis|||Wheezing||0.078|0.020|0.0057
72462289|NCT04748445|144447610|OTHER||Slope|2.644|||<|0.0001|TWO_SIDED|90.0|2.101|3.188|||Mixed Models Analysis|||Mean of daily total symptom score||3.188|2.101|<.0001
72462290|NCT04748445|144447611|OTHER||Slope|-1.519|STANDARD_ERROR_OF_MEAN|2.769|<|0.0001|TWO_SIDED|90.0|-1.978|-1.06|||Mixed Models Analysis|||AHH\_Max Phonation Time (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, lower limit and estimated value it was 10\^-1. For dispersion value it was 10\^-2).||-1.060|-1.978|<.0001
72462291|NCT04748445|144447611|OTHER||Slope|6.899|STANDARD_ERROR_OF_MEAN|0.0|<|0.0001|TWO_SIDED|90.0|||||Mixed Models Analysis|||EE\_Jitter Local Absolute (The statistical data given below have exponential factor in addition to the values mentioned. For estimated value it was 10\^-8).||||<.0001
72462292|NCT04748445|144447611|OTHER||Slope|-1.743|STANDARD_ERROR_OF_MEAN|0.0|<|0.0001|TWO_SIDED|90.0|||||Mixed Models Analysis|||MM\_Jitter Local Absolute (The statistical data given below have exponential factor in addition to the values mentioned. For estimated value it was 10\^-7).||||<.0001
72621108|NCT02732145|144773179|EQUIVALENCE|Is there a difference in the body mass index of patients from different groups.||||||0|||||||ANOVA|||The difference in the body mass index of patients from different groups.||||0.0000
72621109|NCT02732145|144773180|EQUIVALENCE|Question: Is there a difference in the incidence of patients older than 65 years in different groups?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of patients older than 65 years between different groups.||||0.0000
72392945|NCT00545662|144293522|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.98||||0.76|TWO_SIDED|95.0|0.83|1.14||a priori threshold for statistical significance is 0.05|Regression, Logistic|Logistic regression estimated global OR. GEE accounted for correlations of the scales. Models adjusted for site \& injury severity.|The odds in the citicoline group were compared to the odds in the placebo group.|"Null hypothesis: The placebo and citicoline groups do not differ at 90-days on the Core Battery~Power:~1. Two sided type I error of 0.05~2. 85% power~3. Expected OR=1.40 for the global statistic~4. Response rate in the control group~5. Correlations among the nine measures were accounted for. Response rates for the whole sample were a weighted average of the rates provided by TBI severity.~1240 participants were required to detect an OR \>= 1.4 for the global statistic."||1.14|0.83|0.76
72462293|NCT04748445|144447612|OTHER||Slope|-1.326|STANDARD_ERROR_OF_MEAN|1.174||0.9103|TWO_SIDED|90.0|-2.079|1.814|||Mixed Models Analysis|||EE\_Cepstral Peak Prominence (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, lower limit and dispersion value it was 10\^-2. For estimated value it was 10\^-3).||1.814|-2.079|0.9103
72462294|NCT04748445|144447612|OTHER||Slope|0.007667|STANDARD_ERROR_OF_MEAN|1.741||0.6605|TWO_SIDED|90.0|-0.02119|0.03653|||Mixed Models Analysis|||EE\_Harmonicity (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-2).||0.03653|-0.02119|0.6605
72462295|NCT04748445|144447612|OTHER||Slope|1.268|STANDARD_ERROR_OF_MEAN|2.82|<|0.0001|TWO_SIDED|90.0|0.8012|1.736|||Mixed Models Analysis|||EE\_MFCC mean 01 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-1).||1.736|0.8012|<.0001
72462296|NCT04748445|144447612|OTHER||Slope|-1.752|STANDARD_ERROR_OF_MEAN|2.127||0.4117|TWO_SIDED|90.0|-5.276|1.773|||Mixed Models Analysis|||EE\_MFCC mean 02 (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, lower limit, estimated value and dispersion value it was 10\^-1).||1.773|-5.276|0.4117
72462297|NCT04748445|144447612|OTHER||Slope|1.39|STANDARD_ERROR_OF_MEAN|1.262||0.2728|TWO_SIDED|90.0|-7.012|3.482|||Mixed Models Analysis|||EE\_MFCC mean 03 (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, estimated value and dispersion value it was 10\^-1. For lower limit it was 10\^-2).||3.482|-7.012|0.2728
72462298|NCT04748445|144447612|OTHER||Slope|-1.407|STANDARD_ERROR_OF_MEAN|1.194||0.2411|TWO_SIDED|90.0|-3.385|5.724|||Mixed Models Analysis|||EE\_MFCC mean 04 (The statistical data given below have exponential factor in addition to the values mentioned. For lower limit, estimated value and dispersion value it was 10\^-1. For upper limit it was 10\^-2).||5.724|-3.385|0.2411
72462299|NCT04748445|144447612|OTHER||Slope|-0.004466|STANDARD_ERROR_OF_MEAN|8.869||0.9599|TWO_SIDED|90.0|-0.1514|0.1425|||Mixed Models Analysis|||EE\_MFCC mean 05 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-2).||0.1425|-0.1514|0.9599
72462300|NCT04748445|144447612|OTHER||Slope|-0.1572|STANDARD_ERROR_OF_MEAN|9.127||0.0875|TWO_SIDED|90.0|-0.3084|-0.005942|||Mixed Models Analysis|||EE\_MFCC mean 06 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-2).||-0.005942|-0.3084|0.0875
72462301|NCT04748445|144447612|OTHER||Slope|1.248|STANDARD_ERROR_OF_MEAN|7.598||0.1029|TWO_SIDED|90.0|-1.072|2.507|||Mixed Models Analysis|||EE\_MFCC mean 07 (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit and estimated value it was 10\^-1. For dispersion value it was 10\^-2 and for lower limit it was 10\^-3).||2.507|-1.072|0.1029
72462302|NCT04748445|144447612|OTHER||Slope|-1.054|STANDARD_ERROR_OF_MEAN|7.218||0.1468|TWO_SIDED|90.0|-2.25|1.423|||Mixed Models Analysis|||EE\_MFCC mean 08 (The statistical data given below have exponential factor in addition to the values mentioned. For lower limit and estimated value it was 10\^-1. For upper limit and dispersion value it was 10\^-2).||1.423|-2.250|0.1468
72462303|NCT04748445|144447612|OTHER||Slope|0.05944|STANDARD_ERROR_OF_MEAN|6.536||0.3649|TWO_SIDED|90.0|-0.04887|0.1678|||Mixed Models Analysis|||EE\_MFCC mean 09 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-2).||0.1678|-0.04887|0.3649
72621110|NCT02732145|144773180|EQUIVALENCE|Question: Is there a difference in the incidence of menopausal patients among different groups?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of menopausal patients among different groups.||||0.0000
72462304|NCT04748445|144447612|OTHER||Slope|-0.03115|STANDARD_ERROR_OF_MEAN|6.007||0.605|TWO_SIDED|90.0|-0.1307|0.06839|||Mixed Models Analysis|||EE\_MFCC mean 10 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-2).||0.06839|-0.1307|0.6050
72462305|NCT04748445|144447612|OTHER||Slope|-0.01908|STANDARD_ERROR_OF_MEAN|5.932||0.7483|TWO_SIDED|90.0|-0.1174|0.07922|||Mixed Models Analysis|||EE\_MFCC mean 11 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-2).||0.07922|-0.1174|0.7483
72462306|NCT04748445|144447612|OTHER||Slope|-6.574|STANDARD_ERROR_OF_MEAN|5.105||0.9897|TWO_SIDED|90.0|-8.526|8.394|||Mixed Models Analysis|||EE\_MFCC mean 12 (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, lower limit and dispersion value it was 10\^-2. For estimated value it was 10\^-4).||8.394|-8.526|0.9897
72462307|NCT04748445|144447612|OTHER||Slope|5.026|STANDARD_ERROR_OF_MEAN|5.176||0.9228|TWO_SIDED|90.0|-8.074|9.08|||Mixed Models Analysis|||EE\_MFCC mean 13 (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, lower limit and dispersion value it was 10\^-2. For estimated value it was 10\^-3).||9.080|-8.074|0.9228
72462308|NCT04748445|144447612|OTHER||Slope|0.08365|STANDARD_ERROR_OF_MEAN|2.873||0.0043|TWO_SIDED|90.0|0.03604|0.1313|||Mixed Models Analysis|||EE\_MFCC std 01 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-2).||0.1313|0.03604|0.0043
72462309|NCT04748445|144447612|OTHER||Slope|0.02906|STANDARD_ERROR_OF_MEAN|1.181||0.0153|TWO_SIDED|90.0|0.009486|0.04863|||Mixed Models Analysis|||EE\_MFCC std 02 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-2).||0.04863|0.009486|0.0153
72621111|NCT02732145|144773180|EQUIVALENCE|Question: Is there a difference in the incidence of domicile country (Croatia) as a country of birth among patients from different groups.||||||0.3708|||||||Chi-squared|||Parameter: The difference in the incidence of domicile country (Croatia) as a country of birth among patients from different groups.||||0.3708
72462310|NCT04748445|144447612|OTHER||Slope|3.96|STANDARD_ERROR_OF_MEAN|1.447||0.0071|TWO_SIDED|90.0|1.563|6.357|||Mixed Models Analysis|||EE\_MFCC std 03 (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, lower limit, estimated value and dispersion value it was 10\^-2).||6.357|1.563|0.0071
72462311|NCT04748445|144447612|OTHER||Slope|2.816|STANDARD_ERROR_OF_MEAN|1.026||0.007|TWO_SIDED|90.0|1.115|4.516|||Mixed Models Analysis|||EE\_MFCC std 04 (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, lower limit, estimated value and dispersion value it was 10\^-2).||4.516|1.115|0.0070
72462312|NCT04748445|144447612|OTHER||Slope|0.007814|STANDARD_ERROR_OF_MEAN|1.034||0.4513|TWO_SIDED|90.0|-0.009323|0.02495|||Mixed Models Analysis|||EE\_MFCC std 05 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-2).||0.02495|-0.009323|0.4513
72462313|NCT04748445|144447612|OTHER||Slope|1.151|STANDARD_ERROR_OF_MEAN|8.443||0.1753|TWO_SIDED|90.0|-2.483|2.55|||Mixed Models Analysis|||EE\_MFCC std 06 (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit and estimated value it was 10\^-2. For lower limit and dispersion value it was 10\^-3).||2.550|-2.483|0.1753
72462314|NCT04748445|144447612|OTHER||Slope|2.528|STANDARD_ERROR_OF_MEAN|8.228||0.0026|TWO_SIDED|90.0|1.164|3.891|||Mixed Models Analysis|||EE\_MFCC std 07 (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, lower limit and estimated value it was 10\^-2. For dispersion it was 10\^-3).||3.891|1.164|0.0026
72462315|NCT04748445|144447612|OTHER||Slope|0.01755|STANDARD_ERROR_OF_MEAN|7.204||0.0162|TWO_SIDED|90.0|0.005616|0.02949|||Mixed Models Analysis|||EE\_MFCC std 08 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-3).||0.02949|0.005616|0.0162
72462316|NCT04748445|144447612|OTHER||Slope|2.673|STANDARD_ERROR_OF_MEAN|5.892|<|0.0001|TWO_SIDED|90.0|1.697|3.65|||Mixed Models Analysis|||EE\_MFCC std 09 (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, lower limit and estimated value it was 10\^-2. For dispersion value it was 10\^-3).||3.650|1.697|<.0001
72462317|NCT04748445|144447612|OTHER||Slope|0.01394|STANDARD_ERROR_OF_MEAN|5.642||0.0148|TWO_SIDED|90.0|0.004595|0.02329|||Mixed Models Analysis|||EE\_MFCC std 10 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-3).||0.02329|0.004595|0.0148
72462318|NCT04748445|144447612|OTHER||Slope|0.01547|STANDARD_ERROR_OF_MEAN|6.666||0.0219|TWO_SIDED|90.0|0.004425|0.02652|||Mixed Models Analysis|||EE\_MFCC std 11 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-3).||0.02652|0.004425|0.0219
72462319|NCT04748445|144447612|OTHER||Slope|1.118|STANDARD_ERROR_OF_MEAN|6.122||0.0703|TWO_SIDED|90.0|1.032|2.132|||Mixed Models Analysis|||EE\_MFCC std 12 (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit and estimated value it was 10\^-2. For lower limit and dispersion value it was 10\^-3).||2.132|1.032|0.0703
72462320|NCT04748445|144447612|OTHER||Slope|0.0116|STANDARD_ERROR_OF_MEAN|5.226||0.0282|TWO_SIDED|90.0|0.00294|0.02026|||Mixed Models Analysis|||EE\_MFCC std 13 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-3).||0.02026|0.002940|0.0282
72462321|NCT04748445|144447612|OTHER||Slope|0.04771|STANDARD_ERROR_OF_MEAN|3.351||0.157|TWO_SIDED|90.0|-0.007823|0.1032|||Mixed Models Analysis|||EE\_SNR (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-2).||0.1032|-0.007823|0.1570
72462322|NCT04748445|144447612|OTHER||Slope|0.0008053|STANDARD_ERROR_OF_MEAN|9.807||0.4131|TWO_SIDED|90.0|-0.0008199|0.002431|||Mixed Models Analysis|||EE\_Shimmer Local dB (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-4).||0.002431|-0.0008199|0.4131
72462323|NCT04748445|144447612|OTHER||Slope|-0.03945|STANDARD_ERROR_OF_MEAN|1.892||0.0391|TWO_SIDED|90.0|-0.0708|-0.008096|||Mixed Models Analysis|||EE\_Spectral Flatness (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-2).||-0.008096|-0.07080|0.0391
72462324|NCT04748445|144447612|OTHER||Slope|-0.07075|STANDARD_ERROR_OF_MEAN|8.409||0.4018|TWO_SIDED|90.0|-0.2101|0.0686|||Mixed Models Analysis|||EE\_Third Octave Band (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-2).||0.06860|-0.2101|0.4018
72462325|NCT04748445|144447612|OTHER||Slope|1.658|STANDARD_ERROR_OF_MEAN|3.607||0.6466|TWO_SIDED|90.0|-4.319|7.635|||Mixed Models Analysis|||EE\_VLHR (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, lower limit, estimated value and dispersion value it was 10\^-2).||7.635|-4.319|0.6466
72462326|NCT04748445|144447612|OTHER||Slope|1.172|STANDARD_ERROR_OF_MEAN|1.423||0.4118|TWO_SIDED|90.0|-1.186|3.53|||Mixed Models Analysis|||MM\_Cepstral Peak Prominence (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, lower limit, estimated value and dispersion value it was 10\^-2).||3.530|-1.186|0.4118
72462327|NCT04748445|144447612|OTHER||Slope|-1.282|STANDARD_ERROR_OF_MEAN|1.965||0.9481|TWO_SIDED|90.0|-3.385|3.129|||Mixed Models Analysis|||MM\_Harmonicity (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, lower limit and dispersion value it was 10\^-2. For estimated value it was 10\^-3).||3.129|-3.385|0.9481
72462328|NCT04748445|144447612|OTHER||Slope|0.9159|STANDARD_ERROR_OF_MEAN|2.641||0.0007|TWO_SIDED|90.0|0.4783|1.354|||Mixed Models Analysis|||MM\_MFCC mean 01 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-1).||1.354|0.4783|0.0007
72462329|NCT04748445|144447612|OTHER||Slope|-2.18|STANDARD_ERROR_OF_MEAN|1.894||0.2519|TWO_SIDED|90.0|-5.319|9.585|||Mixed Models Analysis|||MM\_MFCC mean 02 (The statistical data given below have exponential factor in addition to the values mentioned. For lower limit, estimated value and dispersion value it was 10\^-1. For upper limit it was 10\^-2).||9.585|-5.319|0.2519
72462330|NCT04748445|144447612|OTHER||Slope|1.821|STANDARD_ERROR_OF_MEAN|1.028||0.0791|TWO_SIDED|90.0|1.166|3.524|||Mixed Models Analysis|||MM\_MFCC mean 03 (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, estimated value and dispersion value it was 10\^-1. For lower limit it was 10\^-2).||3.524|1.166|0.0791
72462331|NCT04748445|144447612|OTHER||Slope|-0.2064|STANDARD_ERROR_OF_MEAN|8.474||0.0163|TWO_SIDED|90.0|-0.3468|-0.06599|||Mixed Models Analysis|||MM\_MFCC mean 04 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-2).||-0.06599|-0.3468|0.0163
72462332|NCT04748445|144447612|OTHER||Slope|-1.265|STANDARD_ERROR_OF_MEAN|9.67||0.1932|TWO_SIDED|90.0|-2.867|3.375|||Mixed Models Analysis|||MM\_MFCC mean 05 (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit and dispersion value it was 10\^-2. For lower limit and estimated value it was 10\^-1).||3.375|-2.867|0.1932
72462333|NCT04748445|144447612|OTHER||Slope|0.02851|STANDARD_ERROR_OF_MEAN|9.96||0.7752|TWO_SIDED|90.0|-0.1365|0.1936|||Mixed Models Analysis|||MM\_MFCC mean 06 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-2).||0.1936|-0.1365|0.7752
72462334|NCT04748445|144447612|OTHER||Slope|1.209|STANDARD_ERROR_OF_MEAN|7.569||0.1126|TWO_SIDED|90.0|-4.48|2.464|||Mixed Models Analysis|||MM\_MFCC mean 07 (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit and estimated value it was 10\^-1. For lower limit it was 10\^-3. For dispersion value it was 10\^-2).||2.464|-4.480|0.1126
72462335|NCT04748445|144447612|OTHER||Slope|-0.2215|STANDARD_ERROR_OF_MEAN|8.498||0.0102|TWO_SIDED|90.0|-0.3624|-0.08072|||Mixed Models Analysis|||MM\_MFCC mean 08 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-2).||-0.08072|-0.3624|0.0102
72462336|NCT04748445|144447612|OTHER||Slope|0.0556|STANDARD_ERROR_OF_MEAN|7.072||0.4332|TWO_SIDED|90.0|-0.06159|0.1728|||Mixed Models Analysis|||MM\_MFCC mean 09 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-2).||0.1728|-0.06159|0.4332
72462337|NCT04748445|144447612|OTHER||Slope|0.01214|STANDARD_ERROR_OF_MEAN|6.19||0.8448|TWO_SIDED|90.0|-0.09044|0.1147|||Mixed Models Analysis|||MM\_MFCC mean 10 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-2).||0.1147|-0.09044|0.8448
72462338|NCT04748445|144447612|OTHER||Slope|-0.1106|STANDARD_ERROR_OF_MEAN|4.852||0.0244|TWO_SIDED|90.0|-0.191|-0.03016|||Mixed Models Analysis|||MM\_MFCC mean 11 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-2).||-0.03016|-0.1910|0.0244
72462339|NCT04748445|144447612|OTHER||Slope|-0.04884|STANDARD_ERROR_OF_MEAN|4.827||0.3136|TWO_SIDED|90.0|-0.1288|0.03115|||Mixed Models Analysis|||MM\_MFCC mean 12 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-2).||0.03115|-0.1288|0.3136
72462340|NCT04748445|144447612|OTHER||Slope|0.036|STANDARD_ERROR_OF_MEAN|5.634||0.524|TWO_SIDED|90.0|-0.05736|0.1294|||Mixed Models Analysis|||MM\_MFCC mean 13 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-2).||0.1294|-0.05736|0.5240
72462341|NCT04748445|144447612|OTHER||Slope|2.909|STANDARD_ERROR_OF_MEAN|3.096||0.3493|TWO_SIDED|90.0|-2.222|8.039|||Mixed Models Analysis|||MM\_MFCC std 01 (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, lower limit, estimated value and dispersion value it was 10\^-2).||8.039|-2.222|0.3493
72462342|NCT04748445|144447612|OTHER||Slope|1.72|STANDARD_ERROR_OF_MEAN|2.595||0.5087|TWO_SIDED|90.0|-2.58|6.019|||Mixed Models Analysis|||MM\_MFCC std 02 (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, lower limit, estimated value and dispersion value it was 10\^-2).||6.019|-2.580|0.5087
72621112|NCT02732145|144773180|EQUIVALENCE|Question: Is there a difference in the incidence of patients educated equally or less than 12 years among different groups?||||||0.018|||||||Chi-squared|||Parameter: The difference in the incidence of patients educated equally or less than 12 years among different groups.||||0.0180
72462343|NCT04748445|144447612|OTHER||Slope|0.004403|STANDARD_ERROR_OF_MEAN|1.503||0.7701|TWO_SIDED|90.0|-0.02051|0.02931|||Mixed Models Analysis|||MM\_MFCC std 03 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-2).||0.02931|-0.02051|0.7701
72462344|NCT04748445|144447612|OTHER||Slope|0.007542|STANDARD_ERROR_OF_MEAN|1.639||0.6461|TWO_SIDED|90.0|-0.01961|0.0347|||Mixed Models Analysis|||MM\_MFCC std 04 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-2).||0.03470|-0.01961|0.6461
72462345|NCT04748445|144447612|OTHER||Slope|2.386|STANDARD_ERROR_OF_MEAN|8.233||0.0044|TWO_SIDED|90.0|1.022|3.75|||Mixed Models Analysis|||MM\_MFCC std 05 (The statistical data given below have (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, lower limit and estimated value it was 10\^-2. For dispersion value it was 10\^-3).||3.750|1.022|0.0044
72462346|NCT04748445|144447612|OTHER||Slope|1.593|STANDARD_ERROR_OF_MEAN|1.243||0.2022|TWO_SIDED|90.0|-4.663|3.652|||Mixed Models Analysis|||MM\_MFCC std 06 (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, estimated value and dispersion value it was 10\^-2. For lower limit it was 10\^-3).||3.652|-4.663|0.2022
72462347|NCT04748445|144447612|OTHER||Slope|0.002902|STANDARD_ERROR_OF_MEAN|1.082||0.789|TWO_SIDED|90.0|-0.01503|0.02084|||Mixed Models Analysis|||MM\_MFCC std 07 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-2).||0.02084|-0.01503|0.7890
72462348|NCT04748445|144447612|OTHER||Slope|1.615|STANDARD_ERROR_OF_MEAN|1.118||0.151|TWO_SIDED|90.0|-2.371|3.467|||Mixed Models Analysis|||MM\_MFCC std 08 (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, estimated value and dispersion value it was 10\^-2. For lower limit it was 10\^-3).||3.467|-2.371|0.1510
72462349|NCT04748445|144447612|OTHER||Slope|1.116|STANDARD_ERROR_OF_MEAN|1.104||0.3138|TWO_SIDED|90.0|-7.126|2.945|||Mixed Models Analysis|||MM\_MFCC std 09 (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, estimated value and dispersion value it was 10\^-2. For lower limit it was 10\^-3).||2.945|-7.126|0.3138
72621113|NCT02732145|144773180|EQUIVALENCE|Question: Is there a difference in marital status among patients from different groups?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of marital status among patients from different groups.||||0.0000
72462350|NCT04748445|144447612|OTHER||Slope|-0.002168|STANDARD_ERROR_OF_MEAN|9.632||0.8223|TWO_SIDED|90.0|-0.01813|0.01379|||Mixed Models Analysis|||MM\_MFCC std 10 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-3).||0.01379|-0.01813|0.8223
72462351|NCT04748445|144447612|OTHER||Slope|1.394|STANDARD_ERROR_OF_MEAN|1.081||0.1997|TWO_SIDED|90.0|-3.978|3.185|||Mixed Models Analysis|||MM\_MFCC std 11 (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, estimated value and dispersion value it was 10\^-2. For lower limit it was 10\^-3).||3.185|-3.978|0.1997
72462352|NCT04748445|144447612|OTHER||Slope|0.01375|STANDARD_ERROR_OF_MEAN|6.622||0.0398|TWO_SIDED|90.0|0.00278|0.02473|||Mixed Models Analysis|||MM\_MFCC std 12 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-3).||0.02473|0.002780|0.0398
72462353|NCT04748445|144447612|OTHER||Slope|-0.002892|STANDARD_ERROR_OF_MEAN|1.205||0.8107|TWO_SIDED|90.0|-0.02286|0.01707|||Mixed Models Analysis|||MM\_MFCC std 13 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-2).||0.01707|-0.02286|0.8107
72462354|NCT04748445|144447612|OTHER||Slope|-3.105|STANDARD_ERROR_OF_MEAN|3.256||0.9242|TWO_SIDED|90.0|-5.706|5.085|||Mixed Models Analysis|||MM\_SNR (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, lower limit and dispersion value it was 10\^-2. For estimated value it was 10\^-3).||5.085|-5.706|0.9242
72462355|NCT04748445|144447612|OTHER||Slope|0.0006145|STANDARD_ERROR_OF_MEAN|9.704||0.5277|TWO_SIDED|90.0|-0.0009936|0.002223|||Mixed Models Analysis|||MM\_Shimmer Local dB (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-4).||0.002223|-0.0009936|0.5277
72462356|NCT04748445|144447612|OTHER||Slope|-2.911|STANDARD_ERROR_OF_MEAN|1.969||0.1418|TWO_SIDED|90.0|-6.174|3.522|||Mixed Models Analysis|||MM\_Spectral Flatness (The statistical data given below have exponential factor in addition to the values mentioned. For lower limit, estimated value and dispersion value it was 10\^-2. For upper limit it was 10\^-3).||3.522|-6.174|0.1418
72462357|NCT04748445|144447612|OTHER||Slope|-0.1487|STANDARD_ERROR_OF_MEAN|8.77||0.0924|TWO_SIDED|90.0|-0.294|-0.003375|||Mixed Models Analysis|||MM\_Third Octave Band (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-2).||-0.003375|-0.2940|0.0924
72462358|NCT04748445|144447612|OTHER||Slope|3.089|STANDARD_ERROR_OF_MEAN|3.396||0.9277|TWO_SIDED|90.0|-5.318|5.936|||Mixed Models Analysis|||MM\_VLHR (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, lower limit and dispersion value it was 10\^-2. For estimated value it was 10\^-3).||5.936|-5.318|0.9277
72462359|NCT04748445|144447612|OTHER||Slope|0.8362|STANDARD_ERROR_OF_MEAN|2.077|<|0.0001|TWO_SIDED|90.0|0.492|1.18|||Mixed Models Analysis|||READ\_MFCC mean 01 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-1).||1.180|0.4920|<.0001
72462360|NCT04748445|144447612|OTHER||Slope|0.03559|STANDARD_ERROR_OF_MEAN|1.147||0.7568|TWO_SIDED|90.0|-0.1545|0.2256|||Mixed Models Analysis|||READ\_MFCC mean 02 (The statistical data given below have (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-1).||0.2256|-0.1545|0.7568
72462361|NCT04748445|144447612|OTHER||Slope|0.2043|STANDARD_ERROR_OF_MEAN|7.752||0.0095|TWO_SIDED|90.0|0.07585|0.3328|||Mixed Models Analysis|||READ\_MFCC mean 03 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-2).||0.3328|0.07585|0.0095
72462362|NCT04748445|144447612|OTHER||Slope|-0.0828|STANDARD_ERROR_OF_MEAN|6.413||0.1991|TWO_SIDED|90.0|-0.1891|0.02348|||Mixed Models Analysis|||READ\_MFCC mean 04 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-2).||0.02348|-0.1891|0.1991
72621114|NCT02732145|144773180|EQUIVALENCE|Question: Is there a difference in the nulliparity among patients from different groups?||||||0|||||||Chi-squared|||Parameter: The difference in the nulliparity among patients from different groups.||||0.0000
72462363|NCT04748445|144447612|OTHER||Slope|-0.02415|STANDARD_ERROR_OF_MEAN|5.26||0.6469|TWO_SIDED|90.0|-0.1113|0.06301|||Mixed Models Analysis|||READ\_MFCC mean 05 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-2).||0.06301|-0.1113|0.6469
72462364|NCT04748445|144447612|OTHER||Slope|-0.1209|STANDARD_ERROR_OF_MEAN|4.904||0.015|TWO_SIDED|90.0|-0.2022|-0.03967|||Mixed Models Analysis|||READ\_MFCC mean 06 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-2).||-0.03967|-0.2022|0.0150
72462365|NCT04748445|144447612|OTHER||Slope|0.02617|STANDARD_ERROR_OF_MEAN|4.639||0.5736|TWO_SIDED|90.0|-0.0507|0.103|||Mixed Models Analysis|||READ\_MFCC mean 07 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-2).||0.1030|-0.05070|0.5736
72462366|NCT04748445|144447612|OTHER||Slope|-0.07305|STANDARD_ERROR_OF_MEAN|4.267||0.0894|TWO_SIDED|90.0|-0.1438|-0.002335|||Mixed Models Analysis|||READ\_MFCC mean 08 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-2).||-0.002335|-0.1438|0.0894
72462367|NCT04748445|144447612|OTHER||Slope|-2.369|STANDARD_ERROR_OF_MEAN|4.428||0.5936|TWO_SIDED|90.0|-9.706|4.968|||Mixed Models Analysis|||READ\_MFCC mean 09 (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, lower limit, estimated value and dispersion value it was 10\^-2).||4.968|-9.706|0.5936
72462368|NCT04748445|144447612|OTHER||Slope|-0.07377|STANDARD_ERROR_OF_MEAN|3.339||0.029|TWO_SIDED|90.0|-0.1291|-0.01844|||Mixed Models Analysis|||READ\_MFCC mean 10 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-2).||-0.01844|-0.1291|0.0290
72462369|NCT04748445|144447612|OTHER||Slope|0.008703|STANDARD_ERROR_OF_MEAN|3.665||0.8127|TWO_SIDED|90.0|-0.05203|0.06944|||Mixed Models Analysis|||READ\_MFCC mean 11 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-2).||0.06944|-0.05203|0.8127
72462370|NCT04748445|144447612|OTHER||Slope|-0.07414|STANDARD_ERROR_OF_MEAN|3.294||0.0262|TWO_SIDED|90.0|-0.1287|-0.01955|||Mixed Models Analysis|||READ\_MFCC mean 12 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-2).||-0.01955|-0.1287|0.0262
72621115|NCT02732145|144773180|EQUIVALENCE|Question: Is there a difference in the multiparity among patients from different groups?||||||0|||||||Chi-squared|||Parameter: The difference in the multiparity among patients from different groups.||||0.0000
72392946|NCT03926169|144293523|SUPERIORITY||Adjusted Response Rate Difference (%)|6.0||||0.422|TWO_SIDED|97.5|-10.8|22.8||Across the strata, 97.5% confidence interval for adjusted difference and P-value were calculated according to the Cochran-Mantel-Haenszel test adjusted for the actual values stratification factors under a two-sided alpha level 0.025 for each dose.|Cochran-Mantel-Haenszel|||||22.8|-10.8|0.422
72462371|NCT04748445|144447612|OTHER||Slope|2.929|STANDARD_ERROR_OF_MEAN|2.705||0.2809|TWO_SIDED|90.0|-1.553|7.412|||Mixed Models Analysis|||READ\_MFCC mean 13 (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, lower limit, estimated value and dispersion value it was 10\^-2).||7.412|-1.553|0.2809
72462372|NCT04748445|144447612|OTHER||Slope|-2.717|STANDARD_ERROR_OF_MEAN|6.612|<|0.0001|TWO_SIDED|90.0|-3.812|-1.621|||Mixed Models Analysis|||READ\_MFCC std 01 (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, lower limit and estimated value it was 10\^-1. For dispersion value it was 10\^-2).||-1.621|-3.812|<.0001
72462373|NCT04748445|144447612|OTHER||Slope|-0.05798|STANDARD_ERROR_OF_MEAN|2.961||0.0524|TWO_SIDED|90.0|-0.107|-0.008915|||Mixed Models Analysis|||READ\_MFCC std 02 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-2).||-0.008915|-0.1070|0.0524
72462374|NCT04748445|144447612|OTHER||Slope|-1.008|STANDARD_ERROR_OF_MEAN|1.778||0.5716|TWO_SIDED|90.0|-3.955|1.938|||Mixed Models Analysis|||READ\_MFCC std 03 (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, lower limit, estimated value and dispersion value it was 10\^-2).||1.938|-3.955|0.5716
72462375|NCT04748445|144447612|OTHER||Slope|-0.0223|STANDARD_ERROR_OF_MEAN|1.193||0.064|TWO_SIDED|90.0|-0.04208|-0.002526|||Mixed Models Analysis|||READ\_MFCC std 04 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-2).||-0.002526|-0.04208|0.0640
72462376|NCT04748445|144447612|OTHER||Slope|-1.336|STANDARD_ERROR_OF_MEAN|1.176||0.2584|TWO_SIDED|90.0|-3.285|6.138|||Mixed Models Analysis|||READ\_MFCC std 05 (The statistical data given below have exponential factor in addition to the values mentioned. For lower limit, estimated value and dispersion value it was 10\^-2. For upper limit it was 10\^-3).||6.138|-3.285|0.2584
72462377|NCT04748445|144447612|OTHER||Slope|-0.006497|STANDARD_ERROR_OF_MEAN|1.413||0.6465|TWO_SIDED|90.0|-0.02992|0.01692|||Mixed Models Analysis|||READ\_MFCC std 06 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-2).||0.01692|-0.02992|0.6465
72462378|NCT04748445|144447612|OTHER||Slope|-1.213|STANDARD_ERROR_OF_MEAN|7.7||0.1177|TWO_SIDED|90.0|-2.489|6.297|||Mixed Models Analysis|||READ\_MFCC std 07 (The statistical data given below have exponential factor in addition to the values mentioned. For lower limit and estimated value it was 10\^-2. For dispersion value it was 10\^-3 and for upper limit it was 10\^-4).||6.297|-2.489|0.1177
72462379|NCT04748445|144447612|OTHER||Slope|-0.007959|STANDARD_ERROR_OF_MEAN|9.743||0.4155|TWO_SIDED|90.0|-0.02411|0.008187|||Mixed Models Analysis|||READ\_MFCC std 08 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-3).||0.008187|-0.02411|0.4155
72462380|NCT04748445|144447612|OTHER||Slope|-0.004137|STANDARD_ERROR_OF_MEAN|8.017||0.6067|TWO_SIDED|90.0|-0.01742|0.009148|||Mixed Models Analysis|||READ\_MFCC std 09 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-3).||0.009148|-0.01742|0.6067
72462381|NCT04748445|144447612|OTHER||Slope|0.000376|STANDARD_ERROR_OF_MEAN|7.531||0.9603|TWO_SIDED|90.0|-0.0121|0.01286|||Mixed Models Analysis|||READ\_MFCC std 10 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-3).||0.01286|-0.01210|0.9603
72462382|NCT04748445|144447612|OTHER||Slope|-0.002185|STANDARD_ERROR_OF_MEAN|5.703||0.7022|TWO_SIDED|90.0|-0.01164|0.007265|||Mixed Models Analysis|||READ\_MFCC std 11 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-3).||0.007265|-0.01164|0.7022
72392947|NCT03926169|144293523|SUPERIORITY||Adjusted Response Rate Difference (%)|1.3||||0.858|TWO_SIDED|97.5|-15.4|18.1||Across the strata, 97.5% confidence interval for adjusted difference and P-value were calculated according to the Cochran-Mantel-Haenszel test adjusted for the actual values stratification factors under a two-sided alpha level 0.025 for each dose.|Cochran-Mantel-Haenszel|||||18.1|-15.4|0.858
72462383|NCT04748445|144447612|OTHER||Slope|0.007716|STANDARD_ERROR_OF_MEAN|5.746||0.1818|TWO_SIDED|90.0|-0.001806|0.01724|||Mixed Models Analysis|||READ\_MFCC std 12 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-3).||0.01724|-0.001806|0.1818
72462384|NCT04748445|144447612|OTHER||Slope|-0.004019|STANDARD_ERROR_OF_MEAN|6.419||0.5324|TWO_SIDED|90.0|-0.01466|0.006618|||Mixed Models Analysis|||READ\_MFCC std 13 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-3).||0.006618|-0.01466|0.5324
72462385|NCT04748445|144447612|OTHER||Slope|0.005103|STANDARD_ERROR_OF_MEAN|2.737||0.8524|TWO_SIDED|90.0|-0.04025|0.05046|||Mixed Models Analysis|||READ\_SNR (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-2).||0.05046|-0.04025|0.8524
72462386|NCT04748445|144447613|OTHER||Slope|2.975|STANDARD_ERROR_OF_MEAN|3.383||0.3809|TWO_SIDED|90.0|-2.631|8.58|||Mixed Models Analysis|||EE\_Coefficient of Variation F0 (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, lower limit, estimated value and dispersion value it was 10\^-4.||8.580|-2.631|0.3809
72462387|NCT04748445|144447613|OTHER||Slope|-0.005601|STANDARD_ERROR_OF_MEAN|2.751||0.0438|TWO_SIDED|90.0|-0.01016|-0.001043|||Mixed Models Analysis|||EE\_MFCC 1st order delta 01 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-3.||-0.001043|-0.01016|0.0438
72462388|NCT04748445|144447613|OTHER||Slope|4.12|STANDARD_ERROR_OF_MEAN|1.464||0.0057|TWO_SIDED|90.0|1.694|6.546|||Mixed Models Analysis|||EE\_MFCC 1st order delta 02 (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, lower limit, estimated value and dispersion value it was 10\^-3.||6.546|1.694|0.0057
72462389|NCT04748445|144447613|OTHER||Slope|-3.067|STANDARD_ERROR_OF_MEAN|1.053||0.0042|TWO_SIDED|90.0|-4.811|-1.323|||Mixed Models Analysis|||EE\_MFCC 1st order delta 03 (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, lower limit, estimated value and dispersion value it was 10\^-3.||-1.323|-4.811|0.0042
72392948|NCT03926169|144293524|SUPERIORITY||Adjusted Response Rate Difference (%)|-3.0||||0.725|TWO_SIDED|97.5|-21.8|15.9||Across the strata, 97.5% confidence interval for adjusted difference and P-value were calculated according to the Cochran-Mantel-Haenszel test adjusted for the actual values stratification factors under a two-sided alpha level 0.025 for each dose.|Cochran-Mantel-Haenszel|||||15.9|-21.8|0.725
72392949|NCT03926169|144293524|SUPERIORITY||Adjusted Response Rate Difference (%)|8.8||||0.301|TWO_SIDED|97.5|-10.3|27.8||Across the strata, 97.5% confidence interval for adjusted difference and P-value were calculated according to the Cochran-Mantel-Haenszel test adjusted for the actual values stratification factors under a two-sided alpha level 0.025 for each dose.|Cochran-Mantel-Haenszel|||||27.8|-10.3|0.301
72392950|NCT03926169|144293525|SUPERIORITY||Adjusted Response Rate Difference (%)|3.7||||0.65|TWO_SIDED|97.5|-14.5|21.8||Across the strata, 97.5% confidence interval for adjusted difference and P-value were calculated according to the Cochran-Mantel-Haenszel test adjusted for the actual values stratification factors under a two-sided alpha level 0.025 for each dose.|Cochran-Mantel-Haenszel|||||21.8|-14.5|0.650
72392951|NCT03926169|144293525|SUPERIORITY||Adjusted Response Rate Difference (%)|12.3||||0.147|TWO_SIDED|97.5|-6.7|31.3||Across the strata, 97.5% confidence interval for adjusted difference and P-value were calculated according to the Cochran-Mantel-Haenszel test adjusted for the actual values stratification factors under a two-sided alpha level 0.025 for each dose.|Cochran-Mantel-Haenszel|||||31.3|-6.7|0.147
72392952|NCT03926169|144293526|SUPERIORITY||Adjusted Response Rate Difference (%)|-6.5||||0.342|TWO_SIDED|97.5|-21.8|8.8||Across the strata, 97.5% confidence interval for adjusted difference and P-value were calculated according to the Cochran-Mantel-Haenszel test adjusted for the actual values stratification factors under a two-sided alpha level 0.025 for each dose.|Cochran-Mantel-Haenszel|||||8.8|-21.8|0.342
72392953|NCT03926169|144293526|SUPERIORITY||Adjusted Response Rate Difference (%)|-10.6||||0.108|TWO_SIDED|97.5|-25.3|4.2||Across the strata, 97.5% confidence interval for adjusted difference and P-value were calculated according to the Cochran-Mantel-Haenszel test adjusted for the actual values stratification factors under a two-sided alpha level 0.025 for each dose.|Cochran-Mantel-Haenszel|||||4.2|-25.3|0.108
72392954|NCT03926169|144293527|SUPERIORITY||LS Mean Difference|-1.3|STANDARD_ERROR_OF_MEAN|0.97||0.179|TWO_SIDED|97.5|-3.5|0.9||Mixed-effect model repeat measures analysis with treatment, visit, treatment by visit interaction, stratification factor and baseline measurement in the model. An unstructured variance covariance matrix is used.|mixed-effect model repeat measures|||||0.9|-3.5|0.179
72392955|NCT03926169|144293527|SUPERIORITY||LS Mean Difference|-1.6|STANDARD_ERROR_OF_MEAN|0.98||0.105|TWO_SIDED|97.5|-3.8|0.6||Mixed-effect model repeat measures analysis with treatment, visit, treatment by visit interaction, stratification factor and baseline measurement in the model. An unstructured variance covariance matrix is used.|mixed-effect model repeat measures|||||0.6|-3.8|0.105
72392956|NCT03926169|144293528|SUPERIORITY||LS Mean Difference|0.118|STANDARD_ERROR_OF_MEAN|0.3385||0.727|TWO_SIDED|97.5|-0.646|0.883||Mixed-effect model repeat measures analysis with treatment, visit, treatment by visit interaction, stratification factor and baseline measurement in the model. An unstructured variance covariance matrix is used.|mixed-effect model repeat measures|||||0.883|-0.646|0.727
72392957|NCT03926169|144293528|SUPERIORITY||LS Mean Difference|-0.015|STANDARD_ERROR_OF_MEAN|0.3273||0.963|TWO_SIDED|97.5|-0.755|0.724||Mixed-effect model repeat measures analysis with treatment, visit, treatment by visit interaction, stratification factor and baseline measurement in the model. An unstructured variance covariance matrix is used.|mixed-effect model repeat measures|||||0.724|-0.755|0.963
72392958|NCT03926169|144293529|SUPERIORITY||LS Mean Difference|0.042|STANDARD_ERROR_OF_MEAN|0.2941||0.886|TWO_SIDED|97.5|-0.622|0.706||Mixed-effect model repeat measures analysis with treatment, visit, treatment by visit interaction, stratification factor and baseline measurement in the model. An unstructured variance covariance matrix is used.|mixed-effect model repeat measures|||||0.706|-0.622|0.886
72392959|NCT03926169|144293529|SUPERIORITY||LS Mean Difference|0.236|STANDARD_ERROR_OF_MEAN|0.2851||0.409|TWO_SIDED|97.5|-0.408|0.879||Mixed-effect model repeat measures analysis with treatment, visit, treatment by visit interaction, stratification factor and baseline measurement in the model. An unstructured variance covariance matrix is used.|mixed-effect model repeat measures|||||0.879|-0.408|0.409
72392960|NCT03926169|144293530|SUPERIORITY||LS Mean Difference|-0.252|STANDARD_ERROR_OF_MEAN|0.3212||0.434|TWO_SIDED|97.5|-0.977|0.473||Mixed-effect model repeat measures analysis with treatment, visit, treatment by visit interaction, stratification factor and baseline measurement in the model. An unstructured variance covariance matrix is used.|mixed-effect model repeat measures|||||0.473|-0.977|0.434
72392961|NCT03926169|144293530|SUPERIORITY||LS Mean Difference|-0.074|STANDARD_ERROR_OF_MEAN|0.3123||0.813|TWO_SIDED|97.5|-0.779|0.631||Mixed-effect model repeat measures analysis with treatment, visit, treatment by visit interaction, stratification factor and baseline measurement in the model. An unstructured variance covariance matrix is used.|mixed-effect model repeat measures|||||0.631|-0.779|0.813
72392962|NCT02615145|144293539|SUPERIORITY|||||||0.111||||||Between group change comparison: overall. The dependent variable is the change of PRISM from Baseline (Visit-Baseline). The analysis is adjusted for Baseline.|ANCOVA|||Week 12||||0.1110
72392963|NCT02615145|144293539|SUPERIORITY||difference in LS means|1.64||||0.2704|TWO_SIDED|95.0|-1.28|4.56||Between group change comparison: 3DAA - 2DAA+RBV. The dependent variable is the change of PRISM from Baseline (Visit-Baseline). The analysis is adjusted for Baseline.|ANCOVA|||Week 12||4.56|-1.28|0.2704
72462390|NCT04748445|144447613|OTHER||Slope|2.78|STANDARD_ERROR_OF_MEAN|9.751||0.0051|TWO_SIDED|90.0|1.164|4.396|||Mixed Models Analysis|||EE\_MFCC 1st order delta 04 (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, lower limit and estimated value it was 10\^-3. For dispersion value it was 10\^-4).||4.396|1.164|0.0051
72462391|NCT04748445|144447613|OTHER||Slope|-1.324|STANDARD_ERROR_OF_MEAN|8.289||0.1128|TWO_SIDED|90.0|-2.698|4.973|||Mixed Models Analysis|||EE\_MFCC 1st order delta 05 (The statistical data given below have exponential factor in addition to the values mentioned. For lower limit and estimated value it was 10\^-3. For upper limit it was 10\^-5 and for dispersion value it was 10\^-4).||4.973|-2.698|0.1128
72462392|NCT04748445|144447613|OTHER||Slope|-0.0002606|STANDARD_ERROR_OF_MEAN|9.707||0.7888|TWO_SIDED|90.0|-0.001869|0.001348|||Mixed Models Analysis|||EE\_MFCC 1st order delta 06 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-4).||0.001348|-0.001869|0.7888
72501839|NCT00473694|144533416|SUPERIORITY||Estimated Treatment Effect|17.04|||<|0.0001|TWO_SIDED|95.0|13.62|21.31||A two-way ANOVA model was used with the logarithm of the recovery time taken as the response variable, and trial site and treatment group were the factors of the model.|ANOVA||The value for estimated treatment effect represents how many times faster the mean time to recovery of the T4/T1 ratio to 0.8 was for participants receiving sugammadex after NMB compared to participants receiving neostigmine after NMB.|||21.31|13.62|<0.0001
72501840|NCT00473694|144533417|SUPERIORITY||Estimated Treatment Effect|17.7|||<|0.0001|TWO_SIDED|95.0|12.85|24.38||A two-way ANOVA model was used with the logarithm of the recovery time taken as the response variable, and trial site and treatment group were the factors of the model.|ANOVA||The value for estimated treatment effect represents how many times faster the mean time to recovery of the T4/T1 ratio to 0.8 was for participants receiving sugammadex after NMB compared to participants receiving neostigmine after NMB.|||24.38|12.85|<0.0001
72501841|NCT05224258|144533493|NON_INFERIORITY|The overall mean change in HbA1c from baseline to end of 3-month study period. The mean change will be estimated and compared to a threshold of -0.38% with a margin of 0.4%.|Mean difference from baseline to exit|-0.2|||<|0.001|TWO_SIDED|95.0|-0.4|-0.1|||t-test, 1 sided||This is one arm study, the differences of HbA1c from baseline to exit were summarized for this endpoint|||-0.1|-0.4|<0.001
72501842|NCT05224258|144533493|NON_INFERIORITY|The overall mean change in HbA1c from baseline to end of 3-month study period. The mean change will be estimated and compared to a threshold of -0.5% with a margin of 0.4%.|Mean difference from baseline to exit|-0.4|||<|0.001|TWO_SIDED|95.0|-0.5|-0.2|||Wilcoxon (Mann-Whitney)||This is one arm study, the differences of HbA1c from baseline to exit were summarized for this endpoint.|||-0.2|-0.5|<0.001
72501843|NCT05224258|144533494|NON_INFERIORITY|The mean % of time in range (TIR 70-180 mg/dL \[3.9 -10.0 mmol/L\]) will be estimated and compared to a threshold of 65.3% with a margin of 7.5% and a significance level of 0.025 (one-sided).|Mean of Final Value|65.7|||<|0.001|TWO_SIDED|95.0|63.5|67.9|||Wilcoxon (Mann-Whitney)||This is one arm study, the Percent of Time in Range (TIR 70-180 mg/dL \[3.9 -10.0 mmol/L\]) from the last 6-7 weeks of 3 month study period was summarized for this endpoint.|||67.9|63.5|<0.001
72392964|NCT02615145|144293539|SUPERIORITY||difference in LS means|-0.09||||0.9516|TWO_SIDED|95.0|-3.17|2.98||Between group change comparison: 3DAA+RBV - 2DAA+RBV. The dependent variable is the change of PRISM from Baseline (Visit-Baseline). The analysis is adjusted for Baseline.|ANCOVA|||Week 12||2.98|-3.17|0.9516
72501844|NCT05224258|144533494|NON_INFERIORITY|The mean % of time in range (TIR 70-180 mg/dL \[3.9 -10.0 mmol/L\]) will be estimated and compared to a threshold of 73.7% with a margin of 7.5% and a significance level of 0.025 (one-sided).|Mean of Final Value|77.1|||<|0.001|TWO_SIDED|95.0|75.4|78.9|||Wilcoxon (Mann-Whitney)||This is one arm study, the Percent of Time in Range (TIR 70-180 mg/dL \[3.9 -10.0 mmol/L\]) from the last 6-7 weeks of 3 month study period was summarized for this endpoint.|||78.9|75.4|<0.001
72621116|NCT02732145|144773180|EQUIVALENCE|Question: Is there a difference in the number of abortions among patients from different groups?||||||0|||||||Chi-squared|||Parameter: The difference in the number of abortions among patients from different groups.||||0.0000
72392965|NCT02615145|144293539|SUPERIORITY||difference in LS means|-1.73||||0.0489|TWO_SIDED|95.0|-3.46|-0.01||Between group change comparison: 3DAA+RBV - 3DAA. The dependent variable is the change of PRISM from Baseline (Visit-Baseline). The analysis is adjusted for Baseline.|ANCOVA|||Week 12||-0.01|-3.46|0.0489
72392966|NCT02615145|144293539|SUPERIORITY|||||||0.9785||||||Between group change comparison: overall. The dependent variable is the change of PRISM from Baseline (Visit-Baseline). The analysis is adjusted for Baseline.|ANCOVA|||Week 48||||0.9785
72501845|NCT05224258|144533495|NON_INFERIORITY|The mean % of time in hypoglycemia (\< 54 mg/dL \[3.0 mmol/L\]) will be estimated and compared to a threshold of 0.71% with a margin of 2% and a significance level of 0.025 (one-sided).|Mean of Final Value|0.3|||<|0.001|TWO_SIDED|95.0|0.3|0.4|||Wilcoxon (Mann-Whitney)||This is one arm study, the Percent of Time in Hypoglycemia (\< 54 mg/dL \[3.0 mmol/L\]) from the last 6-7 weeks of 3 month study period was summarized for this endpoint.|||0.4|0.3|<0.001
72501846|NCT05224258|144533495|NON_INFERIORITY|The mean % of time in hypoglycemia (\< 54 mg/dL \[3.0 mmol/L\]) will be estimated and compared to a threshold of 0.86% with a margin of 2% and a significance level of 0.025 (one-sided).|Mean of Final Value|0.3|||<|0.001|TWO_SIDED|95.0|0.2|0.4|||Wilcoxon (Mann-Whitney)||This is one arm study, the Percent of Time in Hypoglycemia (\< 54 mg/dL \[3.0 mmol/L\]) from the last 6-7 weeks of 3 month study period was summarized for this endpoint.|||0.4|0.2|<0.001
72501847|NCT05224258|144533496|SUPERIORITY|The mean % of time in range (TIR 70-180 mg/dL \[3.9 -10.0 mmol/L\]) will be estimated and compared to a threshold of 65.3% and a significance level of 0.025 (one-sided).|Mean of Final Value|65.7||||0.208|TWO_SIDED|95.0|63.5|67.9|||Wilcoxon (Mann-Whitney)||This is one arm study, the Percent of Time in Range (TIR 70-180 mg/dL \[3.9 -10.0 mmol/L\]) from the last 6-7 weeks of 3 month study period was summarized for this endpoint.|||67.9|63.5|0.208
72501848|NCT05224258|144533496|SUPERIORITY|The mean % of time in range (TIR 70-180 mg/dL \[3.9 -10.0 mmol/L\]) will be estimated and compared to a threshold of 73.7% and a significance level of 0.025 (one-sided).|Mean of Final Value|77.1|||<|0.001|TWO_SIDED|95.0|75.4|78.9|||Wilcoxon (Mann-Whitney)||This is one arm study, the Percent of Time in Range (TIR 70-180 mg/dL \[3.9 -10.0 mmol/L\]) from the last 6-7 weeks of 3 month study period was summarized for this endpoint.|||78.9|75.4|<0.001
72621117|NCT02732145|144773180|EQUIVALENCE|Question: Is there a difference in the using of contraception among patients from different groups?||||||0.1323|||||||Chi-squared|||Parameter: The difference in the using of contraception among patients from different groups.||||0.1323
72621118|NCT02732145|144773181|EQUIVALENCE|Question: Is there a difference in the incidence of symptoms of the dull pain of the vulva among patients with vulvar discomfort?||||||0.3158|||||||Chi-squared|||Parameter: The difference in the incidence of symptoms of the dull pain of the vulva (burning, stinging, soreness, irritation, itching, inflammation, aching) among patients with vulvar discomfort.||||0.3158
72621119|NCT02732145|144773181|EQUIVALENCE|Question: Is there a difference in the incidence of symptoms of the sharp pain of the vulva among patients with vulvar discomfort?||||||0.0007|||||||Chi-squared|||Parameter: The difference in the incidence of symptoms of the sharp pain in the vulva (stabbing, sticking, knife-like pain, paper-cuts pain) among patients with vulvar discomfort.||||0.0007
72462393|NCT04748445|144447613|OTHER||Slope|-0.0005071|STANDARD_ERROR_OF_MEAN|7.593||0.5055|TWO_SIDED|90.0|-0.001765|0.0007512|||Mixed Models Analysis|||EE\_MFCC 1st order delta 07 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-4).||0.0007512|-0.001765|0.5055
72462394|NCT04748445|144447613|OTHER||Slope|0.0003067|STANDARD_ERROR_OF_MEAN|6.273||0.6257|TWO_SIDED|90.0|-0.0007328|0.001346|||Mixed Models Analysis|||EE\_MFCC 1st order delta 08 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-4).||0.001346|-0.0007328|0.6257
72462395|NCT04748445|144447613|OTHER||Slope|-0.001649|STANDARD_ERROR_OF_MEAN|7.998||0.0413|TWO_SIDED|90.0|-0.002974|-0.0003238|||Mixed Models Analysis|||EE\_MFCC 1st order delta 09 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-4).||-0.0003238|-0.002974|0.0413
72462396|NCT04748445|144447613|OTHER||Slope|0.0008236|STANDARD_ERROR_OF_MEAN|7.053||0.2451|TWO_SIDED|90.0|-0.0003452|0.001992|||Mixed Models Analysis|||EE\_MFCC 1st order delta 10 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-4).||0.001992|-0.0003452|0.2451
72462397|NCT04748445|144447613|OTHER||Slope|-0.000292|STANDARD_ERROR_OF_MEAN|6.839||0.6702|TWO_SIDED|90.0|-0.001425|0.0008413|||Mixed Models Analysis|||EE\_MFCC 1st order delta 11 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-4).||0.0008413|-0.001425|0.6702
72462398|NCT04748445|144447613|OTHER||Slope|-0.0003363|STANDARD_ERROR_OF_MEAN|6.312||0.5951|TWO_SIDED|90.0|-0.001382|0.0007097|||Mixed Models Analysis|||EE\_MFCC 1st order delta 12 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-4).||0.0007097|-0.001382|0.5951
72462399|NCT04748445|144447613|OTHER||Slope|0.0007281|STANDARD_ERROR_OF_MEAN|5.677||0.202|TWO_SIDED|90.0|-0.0002126|0.001669|||Mixed Models Analysis|||EE\_MFCC 1st order delta 13 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-4).||0.001669|-0.0002126|0.2020
72462400|NCT04748445|144447613|OTHER||Slope|0.0005153|STANDARD_ERROR_OF_MEAN|1.523||0.7356|TWO_SIDED|90.0|-0.002008|0.003038|||Mixed Models Analysis|||EE\_MFCC 2nd order delta 01 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-3).||0.003038|-0.002008|0.7356
72462401|NCT04748445|144447613|OTHER||Slope|-0.00133|STANDARD_ERROR_OF_MEAN|6.782||0.0522|TWO_SIDED|90.0|-0.002453|-0.0002057|||Mixed Models Analysis|||EE\_MFCC 2nd order delta 02 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-4).||-0.0002057|-0.002453|0.0522
72462402|NCT04748445|144447613|OTHER||Slope|-0.000156|STANDARD_ERROR_OF_MEAN|6.763||0.818|TWO_SIDED|90.0|-0.001277|0.0009647|||Mixed Models Analysis|||EE\_MFCC 2nd order delta 03 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-4).||0.0009647|-0.001277|0.8180
72462403|NCT04748445|144447613|OTHER||Slope|-0.0000971|STANDARD_ERROR_OF_MEAN|6.18||0.8754|TWO_SIDED|90.0|-0.001121|0.000927|||Mixed Models Analysis|||EE\_MFCC 2nd order delta 04 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-4.||0.0009270|-0.001121|0.8754
72462404|NCT04748445|144447613|OTHER||Slope|0.000452|STANDARD_ERROR_OF_MEAN|5.576||0.4192|TWO_SIDED|90.0|-0.0004721|0.001376|||Mixed Models Analysis|||EE\_MFCC 2nd order delta 05 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-4).||0.001376|-0.0004721|0.4192
72462405|NCT04748445|144447613|OTHER||Slope|-0.0001528|STANDARD_ERROR_OF_MEAN|5.586||0.7849|TWO_SIDED|90.0|-0.001079|0.0007729|||Mixed Models Analysis|||EE\_MFCC 2nd order delta 06 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-4).||0.0007729|-0.001079|0.7849
72462406|NCT04748445|144447613|OTHER||Slope|-5.254|STANDARD_ERROR_OF_MEAN|4.217||0.901|TWO_SIDED|90.0|-7.513|6.463|||Mixed Models Analysis|||EE\_MFCC 2nd order delta 07 (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, lower limit and dispersion value it was 10\^-4. For estimated value it was 10\^-5).||6.463|-7.513|0.9010
72462407|NCT04748445|144447613|OTHER||Slope|-0.0004591|STANDARD_ERROR_OF_MEAN|3.83||0.2329|TWO_SIDED|90.0|-0.001094|0.0001755|||Mixed Models Analysis|||EE\_MFCC 2nd order delta 08 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-4).||0.0001755|-0.001094|0.2329
72462408|NCT04748445|144447613|OTHER||Slope|0.0007046|STANDARD_ERROR_OF_MEAN|3.687||0.0583|TWO_SIDED|90.0|0.00009366|0.001315|||Mixed Models Analysis|||EE\_MFCC 2nd order delta 09 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-4).||0.001315|0.00009366|0.0583
72462409|NCT04748445|144447613|OTHER||Slope|-1.564|STANDARD_ERROR_OF_MEAN|3.606||0.6654|TWO_SIDED|90.0|-7.54|4.413|||Mixed Models Analysis|||EE\_MFCC 2nd order delta 10 (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, lower limit, estimated value and dispersion value it was 10\^-4).||4.413|-7.540|0.6654
72462410|NCT04748445|144447613|OTHER||Slope|0.00006573|STANDARD_ERROR_OF_MEAN|2.81||0.8154|TWO_SIDED|90.0|-0.0003998|0.0005313|||Mixed Models Analysis|||EE\_MFCC 2nd order delta 11 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-4).||0.0005313|-0.0003998|0.8154
72462411|NCT04748445|144447613|OTHER||Slope|-0.0004071|STANDARD_ERROR_OF_MEAN|3.664||0.2687|TWO_SIDED|90.0|-0.001014|0.0002001|||Mixed Models Analysis|||EE\_MFCC 2nd order delta 12 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-4).||0.0002001|-0.001014|0.2687
72462412|NCT04748445|144447613|OTHER||Slope|2.799|STANDARD_ERROR_OF_MEAN|3.317||0.4005|TWO_SIDED|90.0|-2.698|8.296|||Mixed Models Analysis|||EE\_MFCC 2nd order delta 13 (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, lower limit, estimated value and dispersion value it was 10\^-4).||8.296|-2.698|0.4005
72462413|NCT04748445|144447613|OTHER||Slope|1.123|STANDARD_ERROR_OF_MEAN|1.676||0.504|TWO_SIDED|90.0|-1.654|3.901|||Mixed Models Analysis|||MM\_Coefficient of Variation F0 (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, lower limit, estimated value and dispersion value it was 10\^-4).||3.901|-1.654|0.5040
72501849|NCT00768560|144533536|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.69||||||90.0|-12.62|-6.77|||||40 mg BID minus 40 mg OD|The point estimate and 90% confidence interval of the difference of changes in SBP from baseline was estimated by using the analysis of variance (ANOVA) model including the terms: group, subject within a group, dosage and administration and stage as fixed effects.||-6.77|-12.62|
72501850|NCT00768560|144533536|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.06||||||90.0|-2.87|2.98|||||80 mg OD minus 40 mg OD|The point estimate and 90% confidence interval of the difference of changes in SBP from baseline was estimated by using the ANOVA model including the terms: group, subject within a group, dosage and administration and stage as fixed effects.||2.98|-2.87|
72501851|NCT00768560|144533536|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.75||||||90.0|6.83|12.67|||||80 mg OD minus 40 mg BID|The point estimate and 90% confidence interval of the difference of changes in SBP from baseline was estimated by using the ANOVA model including the terms: group, subject within a group, dosage and administration and stage as fixed effects.||12.67|6.83|
72501852|NCT00768560|144533536|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.97||||||90.0|-5.5|-2.44|||||40 mg BID minus 40 mg OD|The point estimate and 90% confidence interval of the difference of changes in DBP from baseline was estimated by using the ANOVA model including the terms: group, subject within a group, dosage and administration and stage as fixed effects.||-2.44|-5.50|
72563629|NCT03396874|144658477|SUPERIORITY|Exact binomial proportion test, R statistical software package: R version 4.3.1 (2023-06-16)|PPV|92.3|||<|1e-07|TWO_SIDED|95.0|90.0|100.0||Per patient basis p-value = 2.2e-16|binomial proportion test|Exact binomial proportion test, R statistical software package: R version 4.3.1 (2023-06-16)||PPV, composite standard, per-patient basis: We determined the positive predictive value (PPV) of 68Ga-PSMA-11 PET for presence of prostate cancer confirmed by conventional imaging, clinical follow-up, and histopathology/biopsy where available. On a per-patient basis, the PPV of conventional imaging ranges between 30-50%. The null hypothesis is that the PPV at 50% will be tested against the alternative hypothesis that the PPV is greater than 50%.||100|90.0|<0.0000001
72563630|NCT03396874|144658477|OTHER|Exact binomial proportion test, R statistical software package: R version 4.3.1 (2023-06-16)|Sensitivity|95.29|||<|1e-07|TWO_SIDED|95.0|93.3|100.0||Per patient basis p-value = 2.2e-16|Sensitivity|||Sensitivity, composite standard, per-patient basis: We determined the sensitivity of 68Ga-PSMA-11 PET for presence of prostate cancer confirmed by conventional imaging, clinical follow-up, and histopathology/biopsy (composite standard of truth). On a per-patient basis, the sensitivity of conventional imaging ranges between 30-50%. The null hypothesis is that the sensitivity at 50% will be tested against the alternative hypothesis that the sensitivity is greater than 50%.||100.00|93.3|<0.0000001
72563631|NCT03396874|144658477|SUPERIORITY|Exact binomial proportion test, R statistical software package: R version 4.3.1 (2023-06-16)|Sensitivity|91.1|||<|1e-07|TWO_SIDED|95.0|86.2|100.0||p-value = 2.2e-16|Exact binomial proportion test|||PPV, composite standard, prostate or prostate bed: PPV of 68Ga-PSMA-11 PET for presence of prostate cancer confirmed by conventional imaging, clinical follow-up, and histopathology/biopsy where available (composite standard of truth). In the prostate or prostate bed, the PPV of conventional imaging ranges between 30-50%. The null hypothesis is that the PPV at 50% will be tested against the alternative hypothesis that the PPV is greater than 50%.||100.00|86.2|<0.0000001
72563632|NCT03396874|144658477|OTHER|Exact binomial proportion test, R statistical software package: R version 4.3.1 (2023-06-16)|Sensitivity|91.72|||<|1e-07|TWO_SIDED|95.0|86.74|100.0||p-value = 2.2e-16 Exact binomial proportion test, R statistical software package: R version 4.3.1 (2023-06-16)|Exact binomial proportion test|||Sensitivity, composite standard, prostate/prostate bed: We determined the sensitivity of 68Ga-PSMA-11 PET for presence of prostate cancer confirmed by conventional imaging, clinical follow-up, and histopathology/biopsy (composite standard of truth). In the prostate or prostate bed, the sensitivity of conventional imaging ranges between 30-50%. The null hypothesis is that the sensitivity at 50% will be tested against the alternative hypothesis that the sensitivity is greater than 50%.||100.00|86.74|<0.0000001
72462414|NCT04748445|144447613|OTHER||Slope|0.00007586|STANDARD_ERROR_OF_MEAN|2.882||0.979|TWO_SIDED|90.0|-0.004701|0.004852|||Mixed Models Analysis|||MM\_MFCC 1st order delta 01 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-3).||0.004852|-0.004701|0.9790
72462415|NCT04748445|144447613|OTHER||Slope|0.0008249|STANDARD_ERROR_OF_MEAN|1.815||0.6503|TWO_SIDED|90.0|-0.002183|0.003833|||Mixed Models Analysis|||MM\_MFCC 1st order delta 02 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-3).||0.003833|-0.002183|0.6503
72501853|NCT00768560|144533536|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.68||||||90.0|-2.21|0.85|||||80 mg OD minus 40 mg OD|The point estimate and 90% confidence interval of the difference of changes in DBP from baseline was estimated by using the ANOVA model including the terms: group, subject within a group, dosage and administration and stage as fixed effects.||0.85|-2.21|
72501854|NCT00768560|144533536|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.29||||||90.0|1.76|4.82|||||80 mg OD minus 40 mg BID|The point estimate and 90% confidence interval of the difference of changes in DBP from baseline was estimated by using the ANOVA model including the terms: group, subject within a group, dosage and administration and stage as fixed effects.||4.82|1.76|
72462416|NCT04748445|144447613|OTHER||Slope|-1.188|STANDARD_ERROR_OF_MEAN|1.322||0.3705|TWO_SIDED|90.0|-3.379|1.003|||Mixed Models Analysis|||MM\_MFCC 1st order delta 03 (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, lower limit, estimated value and dispersion value it was 10\^-3).||1.003|-3.379|0.3705
72462417|NCT04748445|144447613|OTHER||Slope|-0.0007258|STANDARD_ERROR_OF_MEAN|1.101||0.5111|TWO_SIDED|90.0|-0.002551|0.001099|||Mixed Models Analysis|||MM\_MFCC 1st order delta 04 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-3).||0.001099|-0.002551|0.5111
72462418|NCT04748445|144447613|OTHER||Slope|-0.001326|STANDARD_ERROR_OF_MEAN|7.555||0.0816|TWO_SIDED|90.0|-0.002578|-0.0000744|||Mixed Models Analysis|||MM\_MFCC 1st order delta 05 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-4).||-0.0000744|-0.002578|0.0816
72462419|NCT04748445|144447613|OTHER||Slope|0.0005502|STANDARD_ERROR_OF_MEAN|1.056||0.6034|TWO_SIDED|90.0|-0.0012|0.002301|||Mixed Models Analysis|||MM\_MFCC 1st order delta 06 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-3).||0.002301|-0.001200|0.6034
72462420|NCT04748445|144447613|OTHER||Slope|-0.0004691|STANDARD_ERROR_OF_MEAN|7.305||0.522|TWO_SIDED|90.0|-0.00168|0.0007415|||Mixed Models Analysis|||MM\_MFCC 1st order delta 07 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-4).||0.0007415|-0.001680|0.5220
72462421|NCT04748445|144447613|OTHER||Slope|-0.00153|STANDARD_ERROR_OF_MEAN|7.82||0.0526|TWO_SIDED|90.0|-0.002826|-0.0002344|||Mixed Models Analysis|||MM\_MFCC 1st order delta 08 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-4).||-0.0002344|-0.002826|0.0526
72462422|NCT04748445|144447613|OTHER||Slope|0.0004166|STANDARD_ERROR_OF_MEAN|7.294||0.5689|TWO_SIDED|90.0|-0.000792|0.001625|||Mixed Models Analysis|||MM\_MFCC 1st order delta 09 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-4).||0.001625|-0.0007920|0.5689
72462423|NCT04748445|144447613|OTHER||Slope|-0.002112|STANDARD_ERROR_OF_MEAN|7.299||0.0045|TWO_SIDED|90.0|-0.003321|-0.000902|||Mixed Models Analysis|||MM\_MFCC 1st order delta 10 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-4).||-0.0009020|-0.003321|0.0045
72462424|NCT04748445|144447613|OTHER||Slope|-0.0007706|STANDARD_ERROR_OF_MEAN|7.494||0.3058|TWO_SIDED|90.0|-0.002013|0.0004713|||Mixed Models Analysis|||MM\_MFCC 1st order delta 11 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-4).||0.0004713|-0.002013|0.3058
72462425|NCT04748445|144447613|OTHER||Slope|0.0002388|STANDARD_ERROR_OF_MEAN|6.494||0.7137|TWO_SIDED|90.0|-0.0008374|0.001315|||Mixed Models Analysis|||MM\_MFCC 1st order delta 12 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-4).||0.001315|-0.0008374|0.7137
72462426|NCT04748445|144447613|OTHER||Slope|0.0002121|STANDARD_ERROR_OF_MEAN|6.877||0.7583|TWO_SIDED|90.0|-0.0009275|0.001352|||Mixed Models Analysis|||MM\_MFCC 1st order delta 13 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-4).||0.001352|-0.0009275|0.7583
72462427|NCT04748445|144447613|OTHER||Slope|-2.784|STANDARD_ERROR_OF_MEAN|1.667||0.0974|TWO_SIDED|90.0|-5.547|-2.155|||Mixed Models Analysis|||MM\_MFCC 2nd order delta 01 (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit it was 10\^-5. For lower limit, estimated value and dispersion value it was 10\^-3).||-2.155|-5.547|0.0974
72462428|NCT04748445|144447613|OTHER||Slope|-1.368|STANDARD_ERROR_OF_MEAN|9.117||0.881|TWO_SIDED|90.0|-1.648|1.374|||Mixed Models Analysis|||MM\_MFCC 2nd order delta 02 (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit and lower limit it was 10\^-3. For estimated value and dispersion value it was 10\^-4).||1.374|-1.648|0.8810
72462429|NCT04748445|144447613|OTHER||Slope|-0.001551|STANDARD_ERROR_OF_MEAN|6.294||0.0151|TWO_SIDED|90.0|-0.002594|-0.0005077|||Mixed Models Analysis|||MM\_MFCC 2nd order delta 03 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-4).||-0.0005077|-0.002594|0.0151
72462430|NCT04748445|144447613|OTHER||Slope|0.00184|STANDARD_ERROR_OF_MEAN|7.343||0.0135|TWO_SIDED|90.0|0.0006233|0.003057|||Mixed Models Analysis|||MM\_MFCC 2nd order delta 04 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-4).||0.003057|0.0006233|0.0135
72462431|NCT04748445|144447613|OTHER||Slope|0.00129|STANDARD_ERROR_OF_MEAN|5.029||0.0115|TWO_SIDED|90.0|0.0004563|0.002123|||Mixed Models Analysis|||MM\_MFCC 2nd order delta 05 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-4).||0.002123|0.0004563|0.0115
72462432|NCT04748445|144447613|OTHER||Slope|-0.0001473|STANDARD_ERROR_OF_MEAN|5.891||0.8029|TWO_SIDED|90.0|-0.001123|0.0008288|||Mixed Models Analysis|||MM\_MFCC 2nd order delta 06 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-4).||0.0008288|-0.001123|0.8029
72462433|NCT04748445|144447613|OTHER||Slope|-0.0005556|STANDARD_ERROR_OF_MEAN|4.647||0.2342|TWO_SIDED|90.0|-0.001326|0.0002146|||Mixed Models Analysis|||MM\_MFCC 2nd order delta 07 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-4).||0.0002146|-0.001326|0.2342
72462434|NCT04748445|144447613|OTHER||Slope|0.001128|STANDARD_ERROR_OF_MEAN|5.339||0.0366|TWO_SIDED|90.0|0.0002436|0.002013|||Mixed Models Analysis|||MM\_MFCC 2nd order delta 08 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-4).||0.002013|0.0002436|0.0366
72462435|NCT04748445|144447613|OTHER||Slope|-0.0003297|STANDARD_ERROR_OF_MEAN|5.134||0.522|TWO_SIDED|90.0|-0.00118|0.0005212|||Mixed Models Analysis|||MM\_MFCC 2nd order delta 09 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-4).||0.0005212|-0.001180|0.5220
72462436|NCT04748445|144447613|OTHER||Slope|-2.104|STANDARD_ERROR_OF_MEAN|3.528||0.552|TWO_SIDED|90.0|-7.95|3.742|||Mixed Models Analysis|||MM\_MFCC 2nd order delta 10 (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, lower limit, estimated value and dispersion value it was 10\^-4).||3.742|-7.950|0.5520
72462437|NCT04748445|144447613|OTHER||Slope|0.0005126|STANDARD_ERROR_OF_MEAN|4.289||0.2343|TWO_SIDED|90.0|-0.0001981|0.001223|||Mixed Models Analysis|||MM\_MFCC 2nd order delta 11 (The statistical data given below have exponential factor in addition to the values mentioned. For ldispersion value it was 10\^-4).||0.001223|-0.0001981|0.2343
72501861|NCT01128387|144533549|OTHER||Maximum Tolerated Dose|1.5|||||TWO_SIDED|||||||||Dose of Pantiumumab (in combination with Cisplatin \& Fluorouracil - see below)||||
72392967|NCT02615145|144293539|SUPERIORITY||difference in LS means|-0.13||||0.9379|TWO_SIDED|95.0|-3.37|3.11||Between group change comparison: 3DAA - 2DAA+RBV. The dependent variable is the change of PRISM from Baseline (Visit-Baseline). The analysis is adjusted for Baseline.|ANCOVA|||Week 48||3.11|-3.37|0.9379
72392968|NCT02615145|144293539|SUPERIORITY||difference in LS means|0.07||||0.9678|TWO_SIDED|95.0|-3.33|3.47||Between group change comparison: 3DAA+RBV - 2DAA+RBV. The dependent variable is the change of PRISM from Baseline (Visit-Baseline). The analysis is adjusted for Baseline.|ANCOVA|||Week 48||3.47|-3.33|0.9678
72392969|NCT02615145|144293539|SUPERIORITY||difference in LS means|0.2||||0.8373|TWO_SIDED|95.0|-1.7|2.1||Between group change comparison: 3DAA+RBV - 3DAA. The dependent variable is the change of PRISM from Baseline (Visit-Baseline). The analysis is adjusted for Baseline.|ANCOVA|||Week 48||2.10|-1.70|0.8373
72392970|NCT02615145|144293539|SUPERIORITY||Mean Difference (Final Values)|6.37|||<|0.0001|TWO_SIDED|95.0|5.417|7.32|||paired t-test|paired t-test of whether difference in means is 0||Week 12 vs Baseline across all participants||7.320|5.417|< 0.0001
72392971|NCT02615145|144293539|SUPERIORITY||Mean Difference (Final Values)|10.15|||<|0.0001|TWO_SIDED|95.0|8.936|11.362|||paired t-test|paired t-test of whether difference in means is 0||Week 48 vs Baseline across all participants||11.362|8.936|< 0.0001
72462438|NCT04748445|144447613|OTHER||Slope|2.703|STANDARD_ERROR_OF_MEAN|4.094||0.5103|TWO_SIDED|90.0|-4.081|9.487|||Mixed Models Analysis|||MM\_MFCC 2nd order delta 12 (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, lower limit, estimated value and dispersion value it was 10\^-4).||9.487|-4.081|0.5103
72462439|NCT04748445|144447613|OTHER||Slope|-0.000202|STANDARD_ERROR_OF_MEAN|5.334||0.7056|TWO_SIDED|90.0|-0.001086|0.0006819|||Mixed Models Analysis|||MM\_MFCC 2nd order delta 13 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-4).||0.0006819|-0.001086|0.7056
72501862|NCT01128387|144533549|OTHER||Maximum Tolerated Dose|60.0|||||TWO_SIDED|||||||||Dose of Cisplatin||||
72501863|NCT01128387|144533549|OTHER||Maximum Tolerated Dose|750.0|||||TWO_SIDED|||||||||Dose of Fluorourcil||||
72501864|NCT01535235|144533554|SUPERIORITY_OR_OTHER|||||||0.63|||||||Wilcoxon (Mann-Whitney)|||||||0.63
72501865|NCT01535235|144533555|SUPERIORITY_OR_OTHER|||||||0.63|||||||Wilcoxon (Mann-Whitney)|||||||0.63
72501866|NCT01021111|144533556|SUPERIORITY_OR_OTHER||||||<|0.01|||||||t-test, 2 sided|||The values from the three jumps were averaged in order to have one mean value per subject per session. Paired Student t-tests (baseline vs. follow-up) were used to evaluate the effects of the training.||||<0.01
72501867|NCT01021111|144533557|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Pearson|||The association between the change in the thigh coronal angular velocity from baseline to follow-up and the change in the knee abduction moment from baseline to follow-up was assessed with the Pearson correlation coefficient (R), alpha =0.05||||<0.05
72501868|NCT00389207|144533559|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin 12% (or 0.12 as proportion)|Risk Difference (RD)|0.016||||0.684||95.0|-0.062|0.095||Test for superiority following confirmation of non-inferiority|Cochran-Mantel-Haenszel|Controlling for screening VL and CD4+ categories (only 373 NVP patients due to empty cells)||||0.095|-0.062|0.684
72392972|NCT02615145|144293544|SUPERIORITY|||||||0.5751||||||Between group change comparison: overall. The dependent variable in the change of FACIT-F \[0-100\] from Baseline (Visit-Baseline). The analysis is adjusted for Baseline.|ANCOVA|||EOT||||0.5751
72462440|NCT04748445|144447613|OTHER||Slope|-2.66|STANDARD_ERROR_OF_MEAN|9.22||0.0046|TWO_SIDED|90.0|-4.188|-1.132|||Mixed Models Analysis|||READ\_MFCC 1st order delta 01 (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, lower limit and dispersion value it was 10\^-3. For estimated value it was 10\^-4).||-1.132|-4.188|0.0046
72501869|NCT00389207|144533559|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin 12% (or 0.12 as proportion)|Risk Difference (RD)|0.025||||0.584||95.0|-0.065|0.115||Test for superiority following confirmation of non-inferiority|Cochran-Mantel-Haenszel|Analysis controlling for screening viral load and CD4+ count categories. N=186 NVP QD patients and N=193 ATZ/r patients.||||0.115|-0.065|0.584
72501870|NCT00389207|144533559|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin 12% (or 0.12 as proportion)|Risk Difference (RD)|0.009||||0.855||95.0|-0.084|0.101||Test for superiority following confirmation of non-inferiority|Cochran-Mantel-Haenszel|Analysis controlling for screening viral load and CD4+ count categories. N=187 NVP QD patients and N=193 ATZ/r patients.||||0.101|-0.084|0.855
72501871|NCT00389207|144533560|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin 12% (or 0.12 as proportion)|Risk Difference (RD)|-0.038||||0.321||95.0|-0.112|0.037||Test for superiority following confirmation of non-inferiority|Cochran-Mantel-Haenszel|Analysis controlling for screening viral load and CD4+ count categories. N=373 NVP QD patients and N=193 ATZ/r patients.||||0.037|-0.112|0.321
72501872|NCT00389207|144533571|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.461||||0.0403||95.0|0.22|0.966|||Regression, Cox|||||0.966|0.220|0.0403
72501873|NCT00389207|144533575|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin 12% (or 0.12 as proportion)|Risk Difference (RD)|-0.097||||0.0109||95.0|-0.171|-0.022||Test for superiority following confirmation of non-inferiority|Cochran-Mantel-Haenszel|Analysis controlling for screening viral load and CD4+ count categories. N=373 NVP QD+BID patients and N=193 ATZ/r patients||||-0.022|-0.171|0.0109
72501874|NCT00389207|144533575|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin 12% (or 0.12 as proportion)|Risk Difference (RD)|-0.072||||0.1033||95.0|-0.158|0.015||Test for superiority following confirmation of non-inferiority|Cochran-Mantel-Haenszel|Analysis controlling for screening viral load and CD4+ count categories. N=186 NVP QD patients and N=193 ATZ/r patients.||||0.015|-0.158|0.1033
72501875|NCT00389207|144533575|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin 12% (or 0.12 as proportion)|Risk Difference (RD)|-0.122||||0.0073||95.0|-0.212|-0.033||Test for superiority following confirmation of non-inferiority|Cochran-Mantel-Haenszel|Analysis controlling for screening viral load and CD4+ count categories. N=187 NVP QD patients and N=193 ATZ/r patients.||||-0.033|-0.212|0.0073
72501876|NCT00389207|144533576|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin 12% (or 0.12 as proportion)|Risk Difference (RD)|-0.117||||0.0031||95.0|-0.194|-0.04||Test for superiority following confirmation of non-inferiority|Cochran-Mantel-Haenszel|Analysis controlling for screening viral load and CD4+ count categories. N=373 NVP QD+BID patients and N=193 ATZ/r patients.||||-0.040|-0.194|0.0031
72563633|NCT03396874|144658477|OTHER|Exact binomial proportion test, R statistical software package: R version 4.3.1 (2023-06-16)|PPV|90.78|||<|1e-07|TWO_SIDED|95.0|85.74|100.0||p-value = 2.2e-16|Exact binomial proportion test|||PPV, composite standard, pelvic lymph nodes: PPV of 68Ga-PSMA-11 PET for presence of prostate cancer confirmed by conventional imaging, clinical follow-up, and histopathology/biopsy where available (composite standard of truth). In the prostate or prostate bed, the PPV of conventional imaging ranges between 30-50%. The null hypothesis is that the PPV at 50% will be tested against the alternative hypothesis that the PPV is greater than 50%.||100.00|85.74|<0.0000001
72621120|NCT02732145|144773181|SUPERIORITY|Question: Is there a difference in the incidence of the dull pain versus the sharp pain of the vulva in the patients with vulvar dermatosis?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of symptoms of the dull pain versus the sharp pain of the vulva in patients with vulvar dermatosis.||||0.0000
72392973|NCT02615145|144293544|SUPERIORITY||difference in LS means|2.29||||0.5176|TWO_SIDED|95.0|-4.66|9.23||Between group change comparison: 3DAA - 2DAA+RBV. The dependent variable in the change of FACIT-F \[0-100\] from Baseline (Visit-Baseline). The analysis is adjusted for Baseline.|ANCOVA|||EoT||9.23|-4.66|0.5176
72462441|NCT04748445|144447613|OTHER||Slope|0.000649|STANDARD_ERROR_OF_MEAN|4.448||0.1471|TWO_SIDED|90.0|-0.0000881|0.001386|||Mixed Models Analysis|||READ\_MFCC 1st order delta 02 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-4).||0.001386|-0.0000881|0.1471
72462442|NCT04748445|144447613|OTHER||Slope|1.355|STANDARD_ERROR_OF_MEAN|3.323||0.6842|TWO_SIDED|90.0|-4.152|6.862|||Mixed Models Analysis|||READ\_MFCC 1st order delta 03 (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, lower limit, estimated value and dispersion value it was 10\^-4).||6.862|-4.152|0.6842
72462443|NCT04748445|144447613|OTHER||Slope|0.00007664|STANDARD_ERROR_OF_MEAN|2.574||0.7664|TWO_SIDED|90.0|-0.0003499|0.0005032|||Mixed Models Analysis|||READ\_MFCC 1st order delta 04 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-4).||0.0005032|-0.0003499|0.7664
72462444|NCT04748445|144447613|OTHER||Slope|-1.708|STANDARD_ERROR_OF_MEAN|2.028||0.4015|TWO_SIDED|90.0|-5.069|1.654|||Mixed Models Analysis|||READ\_MFCC 1st order delta 05 (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, lower limit, estimated value and dispersion value it was 10\^-4).||1.654|-5.069|0.4015
72462445|NCT04748445|144447613|OTHER||Slope|2.51|STANDARD_ERROR_OF_MEAN|1.904||0.1897|TWO_SIDED|90.0|-6.446|5.665|||Mixed Models Analysis|||READ\_MFCC 1st order delta 06 (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, estimated value and dispersion value it was 10\^-4. For lower limit it was 10\^-5).||5.665|-6.446|0.1897
72462446|NCT04748445|144447613|OTHER||Slope|2.393|STANDARD_ERROR_OF_MEAN|1.627||0.1439|TWO_SIDED|90.0|-3.035|5.09|||Mixed Models Analysis|||READ\_MFCC 1st order delta 07 (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, estimated value and dispersion value it was 10\^-4. For lower limit it was 10\^-5).||5.090|-3.035|0.1439
72462447|NCT04748445|144447613|OTHER||Slope|4.111|STANDARD_ERROR_OF_MEAN|1.553||0.0092|TWO_SIDED|90.0|1.537|6.685|||Mixed Models Analysis|||READ\_MFCC 1st order delta 08 (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, lower limit, estimated value and dispersion value it was 10\^-4).||6.685|1.537|0.0092
72392974|NCT02615145|144293544|SUPERIORITY||difference in LS means|0.324||||0.9308|TWO_SIDED|95.0|-7.0|7.64||Between group change comparison: 3DAA+RBV - 2DAA+RBV. The dependent variable in the change of FACIT-F \[0-100\] from Baseline (Visit-Baseline). The analysis is adjusted for Baseline.|ANCOVA|||EoT||7.64|-7.00|0.9308
72392975|NCT02615145|144293544|SUPERIORITY||difference in LS means|-1.96||||0.3462|TWO_SIDED|95.0|-6.06|2.13||Between group change comparison: 3DAA+RBV - 3DAA. The dependent variable in the change of FACIT-F \[0-100\] from Baseline (Visit-Baseline). The analysis is adjusted for Baseline.|ANCOVA|||EoT||2.13|-6.06|0.3462
72462448|NCT04748445|144447613|OTHER||Slope|-0.0000415|STANDARD_ERROR_OF_MEAN|1.134||0.715|TWO_SIDED|90.0|-0.0002294|0.0001464|||Mixed Models Analysis|||READ\_MFCC 1st order delta 09 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-4).||0.0001464|-0.0002294|0.7150
72462449|NCT04748445|144447613|OTHER||Slope|1.593|STANDARD_ERROR_OF_MEAN|1.291||0.2194|TWO_SIDED|90.0|-5.457|3.731|||Mixed Models Analysis|||READ\_MFCC 1st order delta 10 (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, estimated value and dispersion value it was 10\^-4. For lower limit it was 10\^-5).||3.731|-5.457|0.2194
72462450|NCT04748445|144447613|OTHER||Slope|0.0001893|STANDARD_ERROR_OF_MEAN|9.442||0.0471|TWO_SIDED|90.0|0.00003283|0.0003458|||Mixed Models Analysis|||READ\_MFCC 1st order delta 11 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-5).||0.0003458|0.00003283|0.0471
72462451|NCT04748445|144447613|OTHER||Slope|0.000138|STANDARD_ERROR_OF_MEAN|6.614||0.039|TWO_SIDED|90.0|0.0000284|0.0002476|||Mixed Models Analysis|||READ\_MFCC 1st order delta 12 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-5).||0.0002476|0.00002840|0.0390
72462452|NCT04748445|144447613|OTHER||Slope|1.166|STANDARD_ERROR_OF_MEAN|1.04||0.2645|TWO_SIDED|90.0|-5.579|2.89|||Mixed Models Analysis|||READ\_MFCC 1st order delta 13 (The statistical data given below have (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, estimated value and dispersion value it was 10\^-4. For lower limit it was 10\^-5).||2.890|-5.579|0.2645
72462453|NCT04748445|144447613|OTHER||Slope|-0.00119|STANDARD_ERROR_OF_MEAN|5.79||0.042|TWO_SIDED|90.0|-0.002149|-0.0002303|||Mixed Models Analysis|||READ\_MFCC 2nd order delta 01 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-4).||-0.0002303|-0.002149|0.0420
72462454|NCT04748445|144447613|OTHER||Slope|-4.504|STANDARD_ERROR_OF_MEAN|3.04||0.141|TWO_SIDED|90.0|-9.542|5.341|||Mixed Models Analysis|||READ\_MFCC 2nd order delta 02 (The statistical data given below have exponential factor in addition to the values mentioned. For lower limit, estimated value and dispersion value it was 10\^-4. For upper limit it was 10\^-5).||5.341|-9.542|0.1410
72462455|NCT04748445|144447613|OTHER||Slope|2.968|STANDARD_ERROR_OF_MEAN|3.334||0.3751|TWO_SIDED|90.0|-2.557|8.492|||Mixed Models Analysis|||READ\_MFCC 2nd order delta 03 (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, lower limit, estimated value and dispersion value it was 10\^-4).||8.492|-2.557|0.3751
72462456|NCT04748445|144447613|OTHER||Slope|-0.0000796|STANDARD_ERROR_OF_MEAN|2.101||0.7053|TWO_SIDED|90.0|-0.0004277|0.0002685|||Mixed Models Analysis|||READ\_MFCC 2nd order delta 04 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-4).||0.0002685|-0.0004277|0.7053
72501877|NCT00389207|144533576|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin 12% (or 0.12 as proportion)|Risk Difference (RD)|-0.096||||0.0365||95.0|-0.186|-0.006||Test for superiority following confirmation of non-inferiority|Cochran-Mantel-Haenszel|Analysis controlling for screening viral load and CD4+ count categories. N=186 NVP QD patients and N=193 ATZ/r patients.||||-0.006|-0.186|0.0365
72462457|NCT04748445|144447613|OTHER||Slope|5.075|STANDARD_ERROR_OF_MEAN|1.878||0.0078|TWO_SIDED|90.0|1.964|8.187|||Mixed Models Analysis|||READ\_MFCC 2nd order delta 05 (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, lower limit, estimated value and dispersion value it was 10\^-4).||8.187|1.964|0.0078
72462458|NCT04748445|144447613|OTHER||Slope|-1.88|STANDARD_ERROR_OF_MEAN|1.174||0.1119|TWO_SIDED|90.0|-3.826|6.611|||Mixed Models Analysis|||READ\_MFCC 2nd order delta 06 (The statistical data given below have exponential factor in addition to the values mentioned. For lower limit, estimated value and dispersion value it was 10\^-4. For upper limit it was 10\^-6).||6.611|-3.826|0.1119
72462459|NCT04748445|144447613|OTHER||Slope|1.667|STANDARD_ERROR_OF_MEAN|1.164||0.1545|TWO_SIDED|90.0|-2.615|3.596|||Mixed Models Analysis|||READ\_MFCC 2nd order delta 07 (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, estimated value and dispersion value it was 10\^-4. For lower limit it was 10\^-5).||3.596|-2.615|0.1545
72462460|NCT04748445|144447613|OTHER||Slope|1.531|STANDARD_ERROR_OF_MEAN|9.552||0.1114|TWO_SIDED|90.0|-5.164|3.114|||Mixed Models Analysis|||READ\_MFCC 2nd order delta 08 (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit and estimated value it was 10\^-4. For lower limit it was 10\^-6 and for dispersion value it was 10\^-5).||3.114|-5.164|0.1114
72462461|NCT04748445|144447613|OTHER||Slope|0.0001989|STANDARD_ERROR_OF_MEAN|1.076||0.0668|TWO_SIDED|90.0|0.00002067|0.0003772|||Mixed Models Analysis|||READ\_MFCC 2nd order delta 09 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-4).||0.0003772|0.00002067|0.0668
72462462|NCT04748445|144447613|OTHER||Slope|0.00005573|STANDARD_ERROR_OF_MEAN|9.318||0.5509|TWO_SIDED|90.0|-0.0000986|0.0002101|||Mixed Models Analysis|||READ\_MFCC 2nd order delta 10 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-5).||0.0002101|-0.0000986|0.5509
72462463|NCT04748445|144447613|OTHER||Slope|0.00001774|STANDARD_ERROR_OF_MEAN|8.677||0.8383|TWO_SIDED|90.0|-0.000126|0.0001615|||Mixed Models Analysis|||READ\_MFCC 2nd order delta 11 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-5).||0.0001615|-0.0001260|0.8383
72462464|NCT04748445|144447613|OTHER||Slope|0.00007327|STANDARD_ERROR_OF_MEAN|6.63||0.2713|TWO_SIDED|90.0|-0.0000366|0.0001831|||Mixed Models Analysis|||READ\_MFCC 2nd order delta 12 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-5).||0.0001831|-0.0000366|0.2713
72462465|NCT04748445|144447613|OTHER||Slope|0.0001534|STANDARD_ERROR_OF_MEAN|9.067||0.0931|TWO_SIDED|90.0|0.00000317|0.0003037|||Mixed Models Analysis|||READ\_MFCC 2nd order delta 13 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-5).||0.0003037|0.00000317|0.0931
72462466|NCT04748445|144447614|OTHER||Slope|-1.931|STANDARD_ERROR_OF_MEAN|3.554||0.5878|TWO_SIDED|90.0|-7.82|3.958|||Mixed Models Analysis|||EE\_Entropy (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, lower limit, estimated value and dispersion value it was 10\^-3).||3.958|-7.820|0.5878
72462467|NCT04748445|144447614|OTHER||Slope|-1.479|STANDARD_ERROR_OF_MEAN|2.847||0.9587|TWO_SIDED|90.0|-4.866|4.57|||Mixed Models Analysis|||MM\_Entropy (The statistical data given below have exponential factor in addition to the values mentioned. For estimated value it was 10\^-4. For dispersion value, lower limit and upper limit it was 10\^-3).||4.570|-4.866|0.9587
72462468|NCT04748445|144447615|OTHER||Slope|-3.262|STANDARD_ERROR_OF_MEAN|4.487||0.9421|TWO_SIDED|90.0|-7.761|7.109|||Mixed Models Analysis|||EE\_Formant 1 (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, lower limit and dispersion value it was 10\^-1. For estimated value it was 10\^-2).||7.109|-7.761|0.9421
72501878|NCT00389207|144533576|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin 12% (or 0.12 as proportion)|Risk Difference (RD)|-0.139||||0.0033||95.0|-0.231|-0.046||Test for superiority following confirmation of non-inferiority|Cochran-Mantel-Haenszel|Analysis controlling for screening viral load and CD4+ count categories. N=187 NVP QD patients and N=193 ATZ/r patients.||||-0.046|-0.231|0.0033
72462469|NCT04748445|144447615|OTHER||Slope|-0.06912|STANDARD_ERROR_OF_MEAN|5.997||0.9084|TWO_SIDED|90.0|-1.063|0.9247|||Mixed Models Analysis|||EE\_Formant 1 Bandwidth (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-1).||0.9247|-1.063|0.9084
72462470|NCT04748445|144447615|OTHER||Slope|1.985|STANDARD_ERROR_OF_MEAN|1.23||0.8721|TWO_SIDED|90.0|-1.841|2.238|||Mixed Models Analysis|||EE\_Formant 2 (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, lower limit and dispersion value it was 10\^0. For estimated value it was 10\^-1).||2.238|-1.841|0.8721
72462471|NCT04748445|144447615|OTHER||Slope|0.6573|STANDARD_ERROR_OF_MEAN|2.191||0.7647|TWO_SIDED|90.0|-2.974|4.288|||Mixed Models Analysis|||EE\_Formant 2 Bandwidth (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^0).||4.288|-2.974|0.7647
72462472|NCT04748445|144447615|OTHER||Slope|0.6504|STANDARD_ERROR_OF_MEAN|8.958||0.4692|TWO_SIDED|90.0|-0.8341|2.135|||Mixed Models Analysis|||EE\_Formant 3 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-1).||2.135|-0.8341|0.4692
72462473|NCT04748445|144447615|OTHER||Slope|-0.09459|STANDARD_ERROR_OF_MEAN|1.255||0.94|TWO_SIDED|90.0|-2.174|1.985|||Mixed Models Analysis|||EE\_Formant 3 Bandwidth (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^0).||1.985|-2.174|0.9400
72462474|NCT04748445|144447615|OTHER||Slope|0.6945|STANDARD_ERROR_OF_MEAN|7.972||0.3853|TWO_SIDED|90.0|-0.6265|2.015|||Mixed Models Analysis|||MM\_Formant 1 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-1).||2.015|-0.6265|0.3853
72462475|NCT04748445|144447615|OTHER||Slope|0.02424|STANDARD_ERROR_OF_MEAN|1.021||0.9811|TWO_SIDED|90.0|-1.667|1.716|||Mixed Models Analysis|||MM\_Formant 1 Bandwidth (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^0).||1.716|-1.667|0.9811
72462476|NCT04748445|144447615|OTHER||Slope|-0.9256|STANDARD_ERROR_OF_MEAN|1.083||0.3944|TWO_SIDED|90.0|-2.72|0.869|||Mixed Models Analysis|||MM\_Formant 2 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^0).||0.8690|-2.720|0.3944
72462477|NCT04748445|144447615|OTHER||Slope|0.935|STANDARD_ERROR_OF_MEAN|1.289||0.4696|TWO_SIDED|90.0|-1.201|3.071|||Mixed Models Analysis|||MM\_Formant 2 Bandwidth (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^0).||3.071|-1.201|0.4696
72462478|NCT04748445|144447615|OTHER||Slope|2.105|STANDARD_ERROR_OF_MEAN|1.231||0.0896|TWO_SIDED|90.0|0.06596|4.145|||Mixed Models Analysis|||MM\_Formant 3 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^0).||4.145|0.06596|0.0896
72462479|NCT04748445|144447615|OTHER||Slope|1.664|STANDARD_ERROR_OF_MEAN|1.358||0.2227|TWO_SIDED|90.0|-5.864|3.915|||Mixed Models Analysis|||MM\_Formant 3 Bandwidth (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, estimated value and dispersion value it was 10\^0. For lower limit it was 10\^-1).||3.915|-5.864|0.2227
72462480|NCT04748445|144447616|OTHER||Slope|-4.024|STANDARD_ERROR_OF_MEAN|3.122||0.8977|TWO_SIDED|90.0|-5.577|4.772|||Mixed Models Analysis|||EE\_Voiced Frames (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, lower limit, and dispersion value it was 10\^-3. For estimated value it was 10\^-4).||4.772|-5.577|0.8977
72501879|NCT00389207|144533579|NON_INFERIORITY_OR_EQUIVALENCE|H0: Difference in proportions = 0|Difference in proportions|0.001||||0.9784|TWO_SIDED|95.0|-0.065|0.066|||Cochran Chi-Squared|||week 48||0.066|-0.065|0.9784
72501880|NCT00389207|144533579|NON_INFERIORITY_OR_EQUIVALENCE|H0: Difference in proportions = 0|Difference in proportions|0.064||||0.0331|TWO_SIDED|95.0|0.005|0.123|||Cochran Chi-Squared|||week 96||0.123|0.005|0.0331
72501881|NCT00389207|144533579|NON_INFERIORITY_OR_EQUIVALENCE|H0: Difference in proportions = 0|Difference in proportions|0.058||||0.0691|TWO_SIDED|95.0|-0.005|0.121|||Cochran Chi-Squared|||week 144||0.121|-0.005|0.0691
72501882|NCT00389207|144533579|NON_INFERIORITY_OR_EQUIVALENCE|H0: Difference in proportions = 0|Difference in proportions|-0.023||||0.4585|TWO_SIDED|95.0|-0.084|0.038|||Cochran Chi-Squared|||week 48||0.038|-0.084|0.4585
72462481|NCT04748445|144447616|OTHER||Slope|-0.0006624|STANDARD_ERROR_OF_MEAN|7.961||0.407|TWO_SIDED|90.0|-0.001982|0.0006569|||Mixed Models Analysis|||MM\_Voiced Frames (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-4).||0.0006569|-0.001982|0.4070
72501883|NCT00389207|144533579|NON_INFERIORITY_OR_EQUIVALENCE|H0: Difference in proportions = 0|Difference in proportions|0.015||||0.5438|TWO_SIDED|95.0|-0.034|0.064|||Cochran Chi-Squared|||week 96||0.064|-0.034|0.5438
72501884|NCT00389207|144533579|NON_INFERIORITY_OR_EQUIVALENCE|H0: Difference in proportions = 0|Difference in proportions|0.016||||0.5659|TWO_SIDED|95.0|-0.039|0.071|||Cochran Chi-Squared|||week 144||0.071|-0.039|0.5659
72501885|NCT00389207|144533580|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.692||||0.0002||95.0|0.57|0.839|||Regression, Cox|||||0.839|0.570|0.0002
72501886|NCT00389207|144533580|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.63|||<|0.0001||95.0|0.519|0.764|||Regression, Cox|||Cox regression on responders only (N=289 in Nevirapine QD+BID and N=175 in Atazanvir/ritonavir)||0.764|0.519|<0.0001
72462482|NCT04748445|144447617|OTHER||Slope|0.0008654|STANDARD_ERROR_OF_MEAN|1.441||0.5491|TWO_SIDED|90.0|-0.001522|0.003253|||Mixed Models Analysis|||EE\_Jitter Local (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-3).||0.003253|-0.001522|0.5491
72501887|NCT00389207|144533581|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.762||||0.1329||95.0|0.535|1.086|||Regression, Cox|||||1.086|0.535|0.1329
72501888|NCT00389207|144533582|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.731||||0.0444||95.0|0.539|0.992|||Regression, Cox|||||0.992|0.539|0.0444
72501889|NCT02201940|144533630|SUPERIORITY_OR_OTHER||||||<|0.001||||||Participants in the SOF/VEL group were compared to the performance goal of 85% using a 2-sided exact 1-sample binomial test at the 0.05 significance level.|Binomial test|||||||< 0.001
72501890|NCT03192904|144533636|SUPERIORITY|||||||0.004|||||||Chi-squared|||||||0.004
72462483|NCT04748445|144447617|OTHER||Slope|-2.206|STANDARD_ERROR_OF_MEAN|3.176||0.9447|TWO_SIDED|90.0|-5.483|5.042|||Mixed Models Analysis|||MM\_Jitter Local (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, lower limit, and dispersion value it was 10\^-3. For estimated value it was 10\^-4).||5.042|-5.483|0.9447
72462484|NCT04748445|144447618|OTHER||Slope|0.007567|STANDARD_ERROR_OF_MEAN|1.12||0.5004|TWO_SIDED|90.0|-0.01099|0.02612|||Mixed Models Analysis|||EE\_Shimmer Local (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-2).||0.02612|-0.01099|0.5004
72501891|NCT03352245|144533653|SUPERIORITY||Mean Difference (Net)|0.03|STANDARD_ERROR_OF_MEAN|0.2||0.889|TWO_SIDED||||||Mixed Models Analysis|||||||0.889
72501892|NCT03352245|144533654|SUPERIORITY||Mean Difference (Net)|-1.14|STANDARD_ERROR_OF_MEAN|0.88||0.2|TWO_SIDED||||||Mixed Models Analysis|||||||0.20
72501893|NCT03352245|144533655|SUPERIORITY||Mean Difference (Net)|7.79|STANDARD_ERROR_OF_MEAN|5.51||0.166|TWO_SIDED||||||Mixed Models Analysis|||||||0.166
72501894|NCT03352245|144533656|SUPERIORITY||Mean Difference (Net)|-0.64|STANDARD_ERROR_OF_MEAN|3.41||0.853|TWO_SIDED||||||Mixed Models Analysis|||||||0.853
72501895|NCT03352245|144533657|SUPERIORITY||Mean Difference (Net)|17.04|STANDARD_ERROR_OF_MEAN|7.16||0.022|TWO_SIDED||||||Mixed Models Analysis|||||||0.022
72501896|NCT03352245|144533658|SUPERIORITY||Mean Difference (Net)|-0.43|STANDARD_ERROR_OF_MEAN|3.83||0.911|TWO_SIDED||||||Mixed Models Analysis|||||||0.911
72501897|NCT03352245|144533659|SUPERIORITY||Mean Difference (Net)|-5.18|STANDARD_ERROR_OF_MEAN|6.88||0.456|TWO_SIDED||||||Mixed Models Analysis|||||||0.456
72501898|NCT03352245|144533660|SUPERIORITY||Mean Difference (Net)|-2.05|STANDARD_ERROR_OF_MEAN|3.13||0.515|TWO_SIDED||||||Mixed Models Analysis|||||||0.515
72501899|NCT03352245|144533661|SUPERIORITY||Mean Difference (Net)|-8.65|STANDARD_ERROR_OF_MEAN|5.8||0.144|TWO_SIDED||||||Mixed Models Analysis|||||||0.144
72501900|NCT03352245|144533662|SUPERIORITY||Mean Difference (Net)|0.41|STANDARD_ERROR_OF_MEAN|6.28||0.948|TWO_SIDED||||||Mixed Models Analysis|||||||0.948
72501901|NCT03352245|144533663|SUPERIORITY||Mean Difference (Net)|-8.62|STANDARD_ERROR_OF_MEAN|7.45||0.254|TWO_SIDED||||||Mixed Models Analysis|||||||0.254
72501902|NCT03352245|144533664|SUPERIORITY||Mean Difference (Net)|-13.31|STANDARD_ERROR_OF_MEAN|6.62||0.051|TWO_SIDED||||||Mixed Models Analysis|||||||0.051
72563634|NCT03396874|144658477|SUPERIORITY|Exact binomial proportion test, R statistical software package: R version 4.3.1 (2023-06-16)|Sensitivity|96.97|||<|1e-07|TWO_SIDED|95.0|93.2|100.0||p-value = 2.2e-16|Exact binomial proportion test|||Sensitivity, composite standard, pelvic lymph nodes: We determined the sensitivity of 68Ga-PSMA-11 PET for presence of prostate cancer confirmed by conventional imaging, clinical follow-up, and histopathology/biopsy (composite standard of truth). In pelvic lymph nodes, the sensitivity of conventional imaging ranges between 30-50%. The null hypothesis is that the sensitivity at 50% will be tested against the alternative hypothesis that the sensitivity is greater than 50%.||100.00|93.20|<0.0000001
72563635|NCT03396874|144658477|SUPERIORITY|Exact binomial proportion test, R statistical software package: R version 4.3.1 (2023-06-16)|PPV|91.25|||<|1e-07|TWO_SIDED|95.0|84.19|100.0||p-value = 2.9e-15|Exact binomial proportion test|||PPV, composite standard, soft tissues: PPV of 68Ga-PSMA-11 PET for presence of prostate cancer confirmed by conventional imaging, clinical follow-up, and histopathology/biopsy where available (composite standard of truth). In soft tissues, the PPV of conventional imaging ranges between 30-50%. The null hypothesis is that the PPV at 50% will be tested against the alternative hypothesis that the PPV is greater than 50%.||100.00|84.19|<0.0000001
72563636|NCT03396874|144658477|SUPERIORITY|Exact binomial proportion test, R statistical software package: R version 4.3.1 (2023-06-16)|Sensitivity|93.59|||<|1e-07|TWO_SIDED|95.0|86.99|100.0||p-value = 2.2e-16|Exact binomial proportion test|||Sensitivity, composite standard, soft tissues: We determined the sensitivity of 68Ga-PSMA-11 PET for presence of prostate cancer confirmed by conventional imaging, clinical follow-up, and histopathology/biopsy (composite standard of truth). In soft tissues, the sensitivity of conventional imaging ranges between 30-50%. The null hypothesis is that the sensitivity at 50% will be tested against the alternative hypothesis that the sensitivity is greater than 50%.||100.00|86.99|<0.0000001
72563637|NCT03396874|144658477|SUPERIORITY|Exact binomial proportion test, R statistical software package: R version 4.3.1 (2023-06-16)|PPV|95.17|||<|1e-07|TWO_SIDED|95.0|91.12|100.0||p-value = 2.2e-16|Exact binomial proportion test|||PPV, composite standard, bone: PPV of 68Ga-PSMA-11 PET for presence of prostate cancer confirmed by conventional imaging, clinical follow-up, and histopathology/biopsy where available (composite standard of truth). In bone tissues, the PPV of conventional imaging ranges between 30-50%. The null hypothesis is that the PPV at 50% will be tested against the alternative hypothesis that the PPV is greater than 50%.||100.00|91.12|<0.0000001
72563638|NCT03396874|144658477|SUPERIORITY|Exact binomial proportion test, R statistical software package: R version 4.3.1 (2023-06-16)|Sensitivity|100.0|||<|1e-07|TWO_SIDED|95.0|97.85|100.0||p-value = 2.2e-16|Exact binomial proportion test|||Sensitivity, composite standard, bone: We determined the sensitivity of 68Ga-PSMA-11 PET for presence of prostate cancer confirmed by conventional imaging, clinical follow-up, and histopathology/biopsy (composite standard of truth). In bone, the sensitivity of conventional imaging ranges between 30-50%. The null hypothesis is that the sensitivity at 50% will be tested against the alternative hypothesis that the sensitivity is greater than 50%.||100.00|97.85|<0.0000001
72563639|NCT01684878|144658606|SUPERIORITY_OR_OTHER||Hazard Ratio (stratified)|0.88||||0.4983|TWO_SIDED|95.0|0.62|1.27|||2 sided log-rank|||The stratified time-to-event analysis included the treatment group variable plus the following stratification factors: selected chemotherapy cohort (gemcitabine versus topotecan vs paclitaxel), previous anti-angiogenic therapy (yes versus no), and progression-free interval (PFI) since platinum therapy (\< 3 months versus 3-6 months). A hazard ratio \< 1 favored the pertuzumab + chemotherapy treatment arm.||1.27|0.62|0.4983
72563640|NCT01684878|144658608|SUPERIORITY_OR_OTHER||Difference in response rate|6.06||||0.4102|TWO_SIDED|95.0|6.0|18.3|||Fisher Exact||Approximate 95% CI for difference of 2 rates using Hauck-Anderson method.|||18.3|6.0|0.4102
72563641|NCT01684878|144658613|SUPERIORITY_OR_OTHER||Hazard ratio (stratified)|0.9||||0.596|TWO_SIDED|95.0|0.61|1.32|||2 sided log-rank||A hazard ratio \< 1 favored the Pertuzumab + Chemotherapy treatment group|The stratified time-to-event analysis included the treatment group variable plus the following stratification factors: selected chemotherapy cohort (gemcitabine versus topotecan versus paclitaxel), previous angiogenic therapy (yes versus no) and PFI since platinum therapy (\<3 months versus 3-6 months).||1.32|0.61|0.5960
72563642|NCT01867606|144658623|SUPERIORITY|||||||0.29|||||||Fisher Exact|||||||0.29
72563643|NCT01867606|144658625|SUPERIORITY|||||||0.62|||||||Chi-squared|||||||0.62
72621121|NCT02732145|144773181|SUPERIORITY|Question: Is there a difference in the incidence of the dull pain versus the sharp pain of the vulva in the patients with vulvodynia?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of symptoms of the dull pain versus the sharp pain of the vulva in patients with vulvodynia.||||0.0000
72621122|NCT02732145|144773181|EQUIVALENCE|Question: Is there a difference in the incidence of vulvar burning among patients with vulvar discomfort?||||||0.0147|||||||Chi-squared|||Parameter: The difference in the incidence of vulvar burning among patients with vulvar discomfort.||||0.0147
72621123|NCT02732145|144773181|EQUIVALENCE|Question: Is there a difference in the incidence of vulvar stinging among patients with vulvar discomfort?||||||0.8456|||||||Chi-squared|||Parameter: The difference in the incidence of vulvar stinging among patients with vulvar discomfort.||||0.8456
72501903|NCT03352245|144533665|SUPERIORITY||Mean Difference (Net)|4.07|STANDARD_ERROR_OF_MEAN|8.71||0.643|TWO_SIDED||||||Mixed Models Analysis|||||||0.643
72501904|NCT03352245|144533666|SUPERIORITY||Mean Difference (Net)|-9.11|STANDARD_ERROR_OF_MEAN|8.5||0.29|TWO_SIDED||||||Mixed Models Analysis|||||||0.290
72501905|NCT03352245|144533667|SUPERIORITY||Mean Difference (Net)|9.99|STANDARD_ERROR_OF_MEAN|5.49||0.077|TWO_SIDED||||||Mixed Models Analysis|||||||0.077
72501906|NCT03352245|144533668|SUPERIORITY||Mean Difference (Net)|5.27|STANDARD_ERROR_OF_MEAN|4.38||0.237|TWO_SIDED||||||Mixed Models Analysis|||||||0.237
72501907|NCT03352245|144533669|SUPERIORITY||Mean Difference (Net)|1.15|STANDARD_ERROR_OF_MEAN|6.49||0.861|TWO_SIDED||||||Mixed Models Analysis|||||||0.861
72501908|NCT02690701|144533677|SUPERIORITY|This superiority trial compares secukinumab with placebo with a view of demonstrating the superiority of secukinumab over placebo with regards to a specific outcome measure.|Least Square Mean|-0.053|STANDARD_ERROR_OF_MEAN|0.059||0.3712|TWO_SIDED|95.0|-0.169|0.064|||ANCOVA|||Statistical analysis (Analysis of Covariance) of change from baseline in target to background ratio for regions of the aorta at Week 12 (Full Analysis Set)||0.064|-0.169|0.3712
72501909|NCT01309737|144533707|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|10.2|||<|0.0001|TWO_SIDED|95.0|5.33|17.68||Cochran-Mantel-Haenszel statistics adjusted for pooled investigator sites was used for the analysis. Each hypothesis was tested against placebo at significance level of 0.05 (2-sided).|Cochran-Mantel-Haenszel|||For primary endpoint, step-down procedure used to preserve Type I error, sequential order of testing: PGA response for CP-690,550 10 mg versus (vs) placebo at Week 16; Psoriasis Area and Severity Index 75 (PASI75) response for CP-690,550 10 mg vs placebo at Week 16; PGA response for CP-690,550 5 mg vs placebo at Week 16; PASI75 response for CP-690,550 5 mg vs placebo at Week 16. If comparison at preceding step was significant, only then subsequent comparisons were significant.||17.68|5.33|<0.0001
72462485|NCT04748445|144447618|OTHER||Slope|0.00606|STANDARD_ERROR_OF_MEAN|1.101||0.5831|TWO_SIDED|90.0|-0.01219|0.02431|||Mixed Models Analysis|||MM\_Shimmer Local (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-2).||0.02431|-0.01219|0.5831
72563644|NCT02248662|144658630|OTHER|The reported p-value was calculated, and is not attempting to indicate the threshold for statistical significance.|Odds Ratio (OR)|1.0|||<|0.05|TWO_SIDED|95.0||||A two-sided p value of less than 0.05 was considered to indicate statistical significance.|Regression, Logistic|Adjusted percentages for receipt of mastectomy were calculated by setting covariates to their observed mean values.|This group is the reference group.|Unadjusted associations between patient characteristics and the three-level cluster of treatment intensity for primary DCIS were evaluated using Chi-squared tests. We used multivariable modeling to adjust for potential confounders. We also conducted a sensitivity analysis using propensity score matching to balance regional treatment intensity for primary DCIS with respect to the covariates included in the multivariable models.||||<0.05
72563645|NCT02248662|144658630|OTHER|The reported p-value was calculated, and is not attempting to indicate the threshold for statistical significance.|Odds Ratio (OR)|1.05|||<|0.05|TWO_SIDED|95.0|0.71|1.56||A two-sided p value of less than 0.05 was considered to indicate statistical significance.|Chi-squared|||Unadjusted associations between patient characteristics and the three-level cluster of treatment intensity for primary DCIS were evaluated using Chi-squared tests. We used multivariable modeling to adjust for potential confounders. We also conducted a sensitivity analysis using propensity score matching to balance regional treatment intensity for primary DCIS with respect to the covariates included in the multivariable models.||1.56|0.71|<0.05
72563646|NCT02248662|144658630|OTHER||Odds Ratio (OR)|1.9|||<|0.05|TWO_SIDED|95.0|1.27|2.84|||Chi-squared|||||2.84|1.27|<0.05
72563647|NCT03200535|144658637|SUPERIORITY|Superiority analysis|||||<|0.001|||||||Chi-squared|||||||<0.001
72563648|NCT03200535|144658638|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
72563649|NCT01181531|144658643|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.0|STANDARD_ERROR_OF_MEAN|5.3||0.346|TWO_SIDED|95.0|-15.4|5.4||Unadjusted. Model contains baseline stratification factor for type of Vitamin D administered at the site|Mixed Models Analysis||Cinacalcet - Vitamin D|Null hypothesis: no difference in % change from baseline in PTH comparing the two treatment arms.||5.4|-15.4|0.346
72563650|NCT01181531|144658644|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.45||||0.11|TWO_SIDED|95.0|0.92|2.29||Stratified by type of Vitamin D at site|Cochran-Mantel-Haenszel||OR is Cinacalcet: Vitamin D|||2.29|0.92|0.110
72563651|NCT01181531|144658645|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.33||||0.346|TWO_SIDED|95.0|0.74|2.39||stratified by type of Vitamin D at site|Cochran-Mantel-Haenszel||OR is Cinacalcet: Vitamin D|||2.39|0.74|0.346
72563652|NCT00987831|144658646|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|30.0||||0.2738|TWO_SIDED|95.0|5.0|95.0||Definition of Moderate Disease was \</= 3 BILAG B (moderate) organ scores, no A (severe) scores and SLEDAI \</=10. Severe disease was \> 3 BILAG B or \>/= BILAG A or SLEDAI \> 10 or meets definition for severe flare on the SELENA SLEDAI Flare Index|Log Rank|||||95|5|0.2738
72563653|NCT04243096|144658648|OTHER||Mean Difference (Final Values)|4.62|||<|0.0001|TWO_SIDED|95.0|2.6|6.64|||Mixed Models Analysis|||||6.64|2.60|<0.0001
72563654|NCT04243096|144658649|OTHER||Mean Difference (Final Values)|-0.04|||<|0.0001|TWO_SIDED|95.0|-0.06|-0.02|||Mixed Models Analysis|||||-0.02|-0.06|<0.0001
72563655|NCT04243096|144658650|OTHER||Mean Difference (Final Values)|-0.02|||<|0.0001|TWO_SIDED|95.0|-0.03|-0.01|||Mixed Models Analysis|||||-0.01|-0.03|<0.0001
72563656|NCT04243096|144658651|OTHER||Mean Difference (Final Values)|-0.03|||<|0.0001|TWO_SIDED|95.0|-0.04|-0.02|||Mixed Models Analysis|||||-0.02|-0.04|<0.0001
72563657|NCT04243096|144658652|OTHER||Mean Difference (Final Values)|-0.01|||<|0.0001|TWO_SIDED|95.0|-0.01|0.0|||Mixed Models Analysis|||||0.00|-0.01|<0.0001
72563658|NCT04243096|144658653|OTHER||Mean Difference (Final Values)|-0.01||||0.0013|TWO_SIDED|95.0|-0.02|-0.01|||Mixed Models Analysis|||||-0.01|-0.02|0.0013
72563659|NCT04243096|144658654|OTHER||Mean Difference (Final Values)|-0.02||||0.0003|TWO_SIDED|95.0|-0.02|-0.01|||Mixed Models Analysis|||||-0.01|-0.02|0.0003
72563660|NCT04243096|144658655|OTHER||Mean Difference (Final Values)|0.03|||<|0.0001|TWO_SIDED|95.0|0.02|0.04|||Mixed Models Analysis|||||0.04|0.02|<0.0001
72563661|NCT04243096|144658656|OTHER||Mean Difference (Final Values)|0.09|||<|0.0001|TWO_SIDED|95.0|0.06|0.13|||Mixed Models Analysis|||||0.13|0.06|<0.0001
72563662|NCT04243096|144658660|OTHER||Mean Difference (Final Values)|9.96|||<|0.0001|TWO_SIDED|95.0|6.6|13.31|||Mixed Models Analysis|||||13.31|6.60|<0.0001
72563663|NCT04243096|144658661|OTHER||Mean Difference (Final Values)|13.07|||<|0.0001|TWO_SIDED|95.0|9.65|16.48|||Mixed Models Analysis|adjusted for age, sex, BMI, and presence of comorbidities.|Change from baseline to week 12|||16.48|9.65|<0.0001
72563664|NCT04243096|144658662|OTHER||Median Difference (Final Values)|-17.5||||0.1196|TWO_SIDED|95.0|-39.7|4.61|||Mixed Models Analysis|||||4.61|-39.7|0.1196
72563665|NCT04243096|144658664|OTHER||Mean Difference (Final Values)|0.11|||<|0.0001|TWO_SIDED|95.0|-0.04|0.25|||Mixed Models Analysis|||||0.25|-0.04|<0.0001
72563666|NCT04243096|144658665|OTHER||Mean Difference (Final Values)|-1.83|||<|0.0001|TWO_SIDED|95.0|-5.76|2.09|||Mixed Models Analysis|||||2.09|-5.76|<0.0001
72563667|NCT04243096|144658666|OTHER||Mean Difference (Final Values)|-0.15|||<|0.0001|TWO_SIDED|95.0|-0.46|0.16|||Mixed Models Analysis|||||0.16|-0.46|<0.0001
72462486|NCT04748445|144447619|OTHER||Slope|2.13|STANDARD_ERROR_OF_MEAN|3.211|<|0.0001|TWO_SIDED|90.0|1.598|2.662|||Mixed Models Analysis|||READ\_Speaking Rate (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, lower limit, and estimated value it was 10\^-2. For dispersion value it was 10\^-3).||2.662|1.598|<.0001
72392976|NCT02615145|144293544|SUPERIORITY|||||||0.7016||||||Between group change comparison: overall. The dependent variable in the change of FACIT-F \[0-100\] from Baseline (Visit-Baseline). The analysis is adjusted for Baseline.|ANCOVA|||12 Weeks after EoT||||0.7016
72501910|NCT01309737|144533707|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|20.43|||<|0.0001|TWO_SIDED|95.0|8.99|30.59||Cochran-Mantel-Haenszel statistics adjusted for pooled investigator sites was used for the analysis. Each hypothesis was tested against placebo at significance level of 0.05 (2-sided).|Cochran-Mantel-Haenszel|||For primary endpoint, step-down procedure used to preserve Type I error, sequential order of testing: PGA response for CP-690,550 10 mg versus (vs) placebo at Week 16; Psoriasis Area and Severity Index 75 (PASI75) response for CP-690,550 10 mg vs placebo at Week 16; PGA response for CP-690,550 5 mg vs placebo at Week 16; PASI75 response for CP-690,550 5 mg vs placebo at Week 16. If comparison at preceding step was significant, only then subsequent comparisons were significant.||30.59|8.99|<0.0001
72501911|NCT01309737|144533707|SUPERIORITY_OR_OTHER||Percent difference|13.08|STANDARD_ERROR_OF_MEAN|3.62||0.0003|TWO_SIDED|95.0|5.99|20.17|||Normal approximation|||||20.17|5.99|0.0003
72501912|NCT01309737|144533708|SUPERIORITY_OR_OTHER||Least Squares (LS) Mean Difference|-45.73|STANDARD_ERROR_OF_MEAN|3.69|<|0.0001|TWO_SIDED|95.0|-52.98|-38.49||Mixed model analysis with fixed effects for treatment, visit, treatment-by-visit interaction,baseline value and repeated measures for visit. Unstructured covariance matrix was used. Each hypothesis was tested at significance level of 0.025 (2-sided).|Mixed Models Analysis|||For key secondary endpoint, family-wise step-down procedure was used to control Type I error.Sequential order of testing: percent change in BSA at Week 16,PASI90 response at Week 16, change in Dermatology Life Quality Index(DLQI) total score at Week 16,PGA response at Week 4,PASI75 at Week 4, change in DLQI total score at Week 4, percent change in Nail Psoriasis Severity Index(NAPSI) score at Week 16. If comparison at preceding step was significant, then subsequent comparisons were significant.||-38.49|-52.98|<0.0001
72501913|NCT01309737|144533708|SUPERIORITY_OR_OTHER||LS Mean Difference|-58.1|STANDARD_ERROR_OF_MEAN|3.69|<|0.0001|TWO_SIDED|95.0|-65.33|-50.86||Mixed model analysis with fixed effects for treatment, visit, treatment-by-visit interaction,baseline value and repeated measures for visit. Unstructured covariance matrix was used. Each hypothesis was tested at significance level of 0.025 (2-sided).|Mixed Models Analysis|||For key secondary endpoint, family-wise step-down procedure was used to control Type I error.Sequential order of testing: percent change in BSA at Week 16,PASI90 response at Week 16, change in Dermatology Life Quality Index(DLQI) total score at Week 16,PGA response at Week 4,PASI75 at Week 4, change in DLQI total score at Week 4, percent change in Nail Psoriasis Severity Index(NAPSI) score at Week 16. If comparison at preceding step was significant, then subsequent comparisons were significant.||-50.86|-65.33|<0.0001
72563668|NCT04243096|144658667|OTHER||Mean Difference (Final Values)|-1.15|||<|0.0001|TWO_SIDED|95.0|-2.22|-0.08|||Mixed Models Analysis|||||-0.08|-2.22|<0.0001
72563669|NCT04243096|144658668|OTHER||Mean Difference (Final Values)|-0.08|||<|0.0001|TWO_SIDED|95.0|-3.37|3.22|||Mixed Models Analysis|||||3.22|-3.37|<0.0001
72563670|NCT04243096|144658669|OTHER||Mean Difference (Final Values)|6.21||||0.0134|TWO_SIDED|95.0|1.31|11.11|||Mixed Models Analysis|||||11.11|1.31|0.0134
72563671|NCT04243096|144658670|OTHER||Median Difference (Final Values)|1.75|||<|0.0001|TWO_SIDED|95.0|1.16|2.34|||Mixed Models Analysis|||||2.34|1.16|<0.0001
72563672|NCT04243096|144658671|OTHER||Median Difference (Final Values)|-1.19||||0.003|TWO_SIDED|95.0|-1.97|-0.41|||Mixed Models Analysis|||||-0.41|-1.97|0.0030
72392977|NCT02615145|144293544|SUPERIORITY||difference in LS means|-2.61||||0.4002|TWO_SIDED|95.0|-8.71|3.49||Between group change comparison: 3DAA - 2DAA+RBV. The dependent variable in the change of FACIT-F \[0-100\] from Baseline (Visit-Baseline). The analysis is adjusted for Baseline.|ANCOVA|||12 weeks after EoT||3.49|-8.71|0.4002
72392978|NCT02615145|144293544|SUPERIORITY||difference in LS means|-2.33||||0.475|TWO_SIDED|95.0|-8.74|4.08||Between group change comparison: 3DAA+RBV - 2DAA+RBV. The dependent variable in the change of FACIT-F \[0-100\] from Baseline (Visit-Baseline). The analysis is adjusted for Baseline.|ANCOVA|||12 weeks after EoT||4.08|-8.74|0.4750
72563673|NCT04243096|144658672|OTHER||Mean Difference (Final Values)|0.45|||<|0.0001|TWO_SIDED|95.0|0.23|0.67|||Mixed Models Analysis|||||0.67|0.23|<0.0001
72563674|NCT04243096|144658673|OTHER||Mean Difference (Final Values)|35.18|||<|0.0001|TWO_SIDED|95.0|18.7|51.67|||Mixed Models Analysis|||||51.67|18.70|<0.0001
72563675|NCT04243096|144658674|OTHER||Mean Difference (Final Values)|-1.98|||<|0.0001|TWO_SIDED|95.0|-2.57|-1.39|||Mixed Models Analysis|||||-1.39|-2.57|<0.0001
72392979|NCT02615145|144293544|SUPERIORITY||difference in LS means|0.282||||0.874|TWO_SIDED|95.0|-3.21|3.77||Between group change comparison: 3DAA+RBV - 3DAA. The dependent variable in the change of FACIT-F \[0-100\] from Baseline (Visit-Baseline). The analysis is adjusted for Baseline.|ANCOVA|||12 weeks after EoT||3.77|-3.21|0.8740
72501914|NCT01309737|144533708|SUPERIORITY_OR_OTHER||LS Mean Difference|-12.36|STANDARD_ERROR_OF_MEAN|3.0|<|0.0001|TWO_SIDED|95.0|-18.24|-6.48|||Mixed Models Analysis|||LS mean difference was derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction, baseline value and repeated measures for visit. Unstructured covariance matrix was used.||-6.48|-18.24|<0.0001
72563676|NCT00810602|144658690|SUPERIORITY_OR_OTHER||Percent Cumulative Incidence of GVHD|22.0|||||TWO_SIDED|95.0|13.0|36.0||||||Hypothesis: The addition of vorinostat will reduce the incidence of grade 2-4 acute graft versus host disease (GVHD) to 25% or lower by day 100.||36|13|
72563677|NCT00810602|144658692|SUPERIORITY_OR_OTHER||Percent Cumulative Incidence of GVHD|16.0|||||TWO_SIDED|95.0|8.0|30.0||||||||30|8|
72563678|NCT02792218|144658694|SUPERIORITY||rate ratio|0.495|||<|0.001|TWO_SIDED|95.0|0.375|0.655|||negative binomial regression model|||Obtained from fitting a negative binomial regression model with log-link to the number of relapses, adjusted for treatment and region as factors, number of relapses in previous year, baseline EDSS, baseline number of Gd-enhancing lesions and the patient's age at baseline as covariates. The natural log of the time-in-study was used as offset to annualize the relapse rate.||0.655|0.375|<0.001
72563679|NCT02792218|144658695|SUPERIORITY||Hazard Ratio (HR)|0.657||||0.003|TWO_SIDED|95.0|0.5|0.863|||Regression, Cox|||This study was not powered for the analysis of this endpoint individually. It was pre-specified in the study protocol to combine the data from this study with study COMB157G2302 to address this endpoint.||0.863|0.500|0.003
72563680|NCT02792218|144658696|SUPERIORITY||Hazard Ratio (HR)|0.652||||0.029|TWO_SIDED|95.0|0.445|0.956|||Regression, Cox|||This study was not powered for the analysis of this endpoint individually. It was pre-specified in the study protocol to combine the data from this study with study COMB157G2302 to address this endpoint.||0.956|0.445|0.029
72462487|NCT02498418|144447629|EQUIVALENCE|Bioequivalence was demonstrated if 90% confidence interval (CI) of percentage difference between generic rifaximin 200 mg tablets and xifaxan 200 mg tablets was within the equivalence range (-20%, +20%).|Difference in percentage of participants|-0.0193|||||TWO_SIDED|90.0|-0.11|0.07||||||Bioequivalence was evaluated based on the PP analysis set using Z-test with Yates correction.||0.07|-0.11|
72462488|NCT02498418|144447632|SUPERIORITY||Difference in percentage of participants|-0.0195||||0.7899|TWO_SIDED|95.0|-0.09|0.13||Threshold of significance at 0.05 level.|Z-test|||95% CIs was calculated using Z-test with Yates' correction.||0.13|-0.09|0.7899
72501915|NCT01309737|144533709|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|8.5|||<|0.0001||95.0|3.48|17.31||Cochran-Mantel-Haenszel statistics adjusted for pooled investigator sites was used for the analysis. Each hypothesis was tested at significance level of 0.025 (2-sided).|Cochran-Mantel-Haenszel|||For key secondary endpoint, family-wise step-down procedure was used to control Type I error. Sequential order of testing: percent change in BSA at Week 16, PASI90 response at Week 16, change in DLQI total score at Week 16, PGA response at Week 4, PASI75 response at Week 4, change in DLQI total score at Week 4, percent change in NAPSI score at Week 16. If comparison at preceding step was significant, then subsequent comparisons were significant.||17.31|3.48|<0.0001
72501916|NCT01309737|144533709|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|24.53|||<|0.0001|TWO_SIDED|95.0|8.08|46.22||Cochran-Mantel-Haenszel statistics adjusted for pooled investigator sites was used for the analysis. Each hypothesis was tested at significance level of 0.025 (2-sided).|Cochran-Mantel-Haenszel|||For key secondary endpoint, family-wise step-down procedure was used to control Type I error. Sequential order of testing: percent change in BSA at Week 16, PASI90 response at Week 16, change in DLQI total score at Week 16, PGA response at Week 4, PASI75 response at Week 4, change in DLQI total score at Week 4, percent change in NAPSI score at Week 16. If comparison at preceding step was significant, then subsequent comparisons were significant.||46.22|8.08|<0.0001
72501917|NCT01309737|144533709|SUPERIORITY_OR_OTHER||Percent Difference|14.3|STANDARD_ERROR_OF_MEAN|3.36|<|0.0001|TWO_SIDED|95.0|7.72|20.88|||Normal Approximation|||||20.88|7.72|<0.0001
72501918|NCT01309737|144533711|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.97|STANDARD_ERROR_OF_MEAN|0.42|<|0.0001||95.0|-3.8|-2.14||Mixed model analysis with fixed effects for treatment, visit, treatment-by-visit interaction,baseline value and repeated measures for visit. Unstructured covariance matrix was used. Each hypothesis was tested at significance level of 0.025 (2-sided).|Mixed Models Analysis|||Week4: For key secondary endpoint, family-wise step-down procedure was used to control Type I error. Sequential order of testing: percent change in BSA at Week 16, PASI90 response at Week 16, change in DLQI total score at Week 16, PGA response at Week 4, PASI75 response at Week 4, change in DLQI total score at Week 4, percent change in NAPSI score at Week 16. If comparison at preceding step was significant, then subsequent comparisons were significant.||-2.14|-3.80|<0.0001
72501919|NCT01309737|144533711|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.3|STANDARD_ERROR_OF_MEAN|0.42|<|0.0001|TWO_SIDED|95.0|-5.13|-3.47||Mixed model analysis with fixed effects for treatment, visit, treatment-by-visit interaction,baseline value and repeated measures for visit. Unstructured covariance matrix was used. Each hypothesis was tested at significance level of 0.025 (2-sided).|Mixed Models Analysis|||Week 4: For key secondary endpoint, family-wise step-down procedure was used to control Type I error. Sequential order of testing: percent change in BSA at Week 16, PASI90 response at Week 16, change in DLQI total score at Week 16, PGA response at Week 4, PASI75 response at Week 4, change in DLQI total score at Week 4, percent change in NAPSI score at Week 16. If comparison at preceding step was significant, then subsequent comparisons were significant.||-3.47|-5.13|<0.0001
72501920|NCT01309737|144533711|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.33|STANDARD_ERROR_OF_MEAN|0.35||0.0001|TWO_SIDED|95.0|-2.01|-0.65|||Mixed Models Analysis|||Week 4: LS mean difference was derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction, baseline value and repeated measures for visit. Unstructured covariance matrix was used.||-0.65|-2.01|0.0001
72563681|NCT02792218|144658697|SUPERIORITY||Hazard Ratio (HR)|0.676||||0.012|TWO_SIDED|95.0|0.498|0.917|||Regression, Cox|||This study was not powered for the analysis of this endpoint individually. It was pre-specified in the study protocol to combine the data from this study with study COMB157G2302 to address this endpoint.||0.917|0.498|0.012
72462489|NCT02498418|144447632|SUPERIORITY||Difference in percentage of participants|0.033||||0.5987|TWO_SIDED|95.0|-0.07|0.14||Threshold for significance at 0.05 level.|Z-test|||95% CIs was calculated using Z-test with Yates' correction.||0.14|-0.07|0.5987
72462490|NCT03042559|144447637|SUPERIORITY|||||||||||||a priori threshold for statistical significance is \<0.05.|Wilcoxon (Mann-Whitney)|||Data analysis was performed using SPSS Statistics Software version 24.0. We compared mean age (years), Body Mass Index (kg/m2) (BMI), pain duration, and the outcome measures at baseline in both groups at baseline using independent t-test when the distribution of the variable was approximately normal and Mann-Whitney test when the distribution was not normal. The distribution of qualitative variables (gender, affected leg) by group type was examined using Chi Square test.|a priori threshold for statistical significance is \<0.05.|||
72462491|NCT03042559|144447644|SUPERIORITY||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
72504813|NCT03114969|144540516|SUPERIORITY||Odds Ratio (OR)|4.929||||0.007|TWO_SIDED|95.0|1.556|15.612||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Incruse/Anoro Ellipta as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.|||15.612|1.556|0.007
72504814|NCT03114969|144540516|SUPERIORITY||Odds Ratio (OR)|1.208||||0.746|TWO_SIDED|95.0|0.385|3.788||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.|||3.788|0.385|0.746
72392980|NCT02615145|144293544|SUPERIORITY|||||||0.7211||||||Between group change comparison: overall. The dependent variable in the change of FACIT-F \[0-100\] from Baseline (Visit-Baseline). The analysis is adjusted for Baseline.|ANCOVA|||48 weeks after EoT||||0.7211
72462492|NCT03866434|144447672|EQUIVALENCE|90% CIs of geometric mean ratios being within 80% to 125%.|% ratio of Geometric LSmeans|64.225|||||TWO_SIDED|90.0|53.212|77.516|||ANOVA|A 2-factor analysis of variance (ANOVA) model with fixed factors for treatment and participant was fitted to the natural logtransformed PK parameters.|This analysis was performed based on the ratio of geometric LS means and 90% confidence interval for ratio of geometric means expressed as percent.|The means of the log-transformed pharmacokinetic parameters were compared between the two treatments (anagrelide with omeprazole \[Day 8\] versus anagrelide alone \[Day 1\]). In order to estimate the magnitude of the treatment regimen differences, the geometric mean ratio (i.e., the least squares (LS) mean difference in the log-transformed parameters back transformed to the original scale) and their 90 percent (%) confidence intervals (CI) were calculated.||77.516|53.212|
72462493|NCT03866434|144447673|EQUIVALENCE|90% CIs of geometric mean ratios being within 80% to 125%.|%ratio of Geometric LeastSquare(LS)means|82.203|||||TWO_SIDED|90.0|71.501|94.507|||ANOVA|A 2-factor analysis of variance (ANOVA) model with fixed factors for treatment and participant was fitted to the natural logtransformed PK parameters.|This analysis was performed based on the ratio of geometric LS means and 90% confidence interval for ratio of geometric means expressed as percent.|The means of the log-transformed pharmacokinetic parameters were compared between the two treatments (anagrelide with omeprazole \[Day 8\] versus anagrelide alone \[Day 1\]). In order to estimate the magnitude of the treatment regimen differences, the geometric mean ratio (i.e., the LS mean difference in the log-transformed parameters back transformed to the original scale) and their 90% CI were calculated.||94.507|71.501|
72462494|NCT03866434|144447674|EQUIVALENCE|90% CIs of geometric mean ratios being within 80% to 125%.|% ratio of Geometric LS means|73.705|||||TWO_SIDED|90.0|64.555|84.152|||ANOVA|A 2-factor analysis of variance (ANOVA) model with fixed factors for treatment and participant was fitted to the natural logtransformed PK parameters.|This analysis was performed based on the ratio of geometric LS means and 90% confidence interval for ratio of geometric means expressed as percent.|The means of the log-transformed pharmacokinetic parameters were compared between the two treatments (anagrelide with omeprazole \[Day 8\] versus anagrelide alone \[Day 1\]). In order to estimate the magnitude of the treatment regimen differences, the geometric mean ratio (i.e., the LS mean difference in the log-transformed parameters back transformed to the original scale) and their 90% CI were calculated.||84.152|64.555|
72462495|NCT03866434|144447675|EQUIVALENCE|90% CIs of geometric mean ratios being within 80% to 125%.|% ratio of Geometric LS means|85.527|||||TWO_SIDED|90.0|78.163|93.584|||ANOVA|A 2-factor analysis of variance (ANOVA) model with fixed factors for treatment and participant was fitted to the natural logtransformed PK parameters.|This analysis was performed based on the ratio of geometric LS means and 90% confidence interval for ratio of geometric means expressed as percent.|The means of the log-transformed pharmacokinetic parameters were compared between the two treatments (anagrelide with omeprazole \[Day 8\] versus anagrelide alone \[Day 1\]). In order to estimate the magnitude of the treatment regimen differences, the geometric mean ratio (i.e., the LS mean difference in the log-transformed parameters back transformed to the original scale) and their 90% CI were calculated.||93.584|78.163|
72462496|NCT03866434|144447676|EQUIVALENCE|90% CIs of geometric mean ratios being within 80% to 125%.|% ratio of Geometric LS means|73.007|||||TWO_SIDED|90.0|62.528|85.243|||ANOVA|A 2-factor analysis of variance (ANOVA) model with fixed factors for treatment and participant was fitted to the natural logtransformed PK parameters.|This analysis was performed based on the ratio of geometric LS means and 90% confidence interval for ratio of geometric means expressed as percent.|The means of the log-transformed pharmacokinetic parameters were compared between the two treatments (anagrelide with omeprazole \[Day 8\] versus anagrelide alone \[Day 1\]). In order to estimate the magnitude of the treatment regimen differences, the geometric mean ratio (i.e., the LS mean difference in the log-transformed parameters back transformed to the original scale) and their 90% CI were calculated.||85.243|62.528|
72469766|NCT03334253|144463342|SUPERIORITY|"The following assumptions were used in the power calculation:~* 2:1 randomization~* treatment group difference of 0.50D~* standard deviation of 0.80D~* type 1 error of 5% (2-sided)~* up to 10% loss to follow up"|Adjusted mean difference|-0.02|||||TWO_SIDED|95.0|-0.19|0.15|||||Atropine - Placebo Adjusted mean difference, adjusting for baseline refractive error, age, iris color (brown vs. not brown), and race (East Asian vs. non-East Asian).|Null Hypothesis: no difference in mean change in SER from baseline to 24 months between the atropine and placebo groups||0.15|-0.19|
72469767|NCT03334253|144463343|SUPERIORITY|"The following assumptions were used in the power calculation:~* 2:1 randomization~* treatment group difference of 0.50D~* standard deviation of 0.80D~* type 1 error of 5% (2-sided)~* up to 10% loss to follow up"|Adjusted mean difference|-0.04|||||TWO_SIDED|95.0|-0.25|0.17|||||Atropine-Placebo Adjusted mean difference, adjusting for baseline refractive error, age, iris color (brown vs. not brown), and race (East Asian vs. non-East Asian).|Null Hypothesis: no difference in mean change in SER from baseline to 24 months between the atropine and placebo groups||0.17|-0.25|
72469768|NCT00203047|144463344|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.03|STANDARD_ERROR_OF_MEAN|0.11820976||0.8023|TWO_SIDED|95.0|-0.26|0.2|||ANCOVA|||||0.20|-0.26|0.8023
72469769|NCT00340704|144463368|SUPERIORITY_OR_OTHER||Slope|1.0039|STANDARD_ERROR_OF_MEAN|0.1725||||95.0|0.6499|1.3579|||||Based on the estimate for the slope parameter, a two sided 95% confidence interval for the slope was computed. Perfect dose proportionality would correspond to a slope of 1. Standard error (SE) of the mean is actually SE of the slope.|Dose proportionality for Cmax,ss was explored based on the regression model.||1.3579|0.6499|
72563682|NCT02792218|144658698|SUPERIORITY||Hazard Ratio (HR)|0.607||||0.022|TWO_SIDED|95.0|0.396|0.93|||Regression, Cox|||This study was not powered for the analysis of this endpoint individually. It was pre-specified in the study protocol to combine the data from this study with study COMB157G2302 to address this endpoint.||0.930|0.396|0.022
72469770|NCT00340704|144463372|SUPERIORITY_OR_OTHER||Slope|0.98|STANDARD_ERROR_OF_MEAN|0.1884||||95.0|0.5934|1.3666|||||Based on the estimate for the slope parameter, a two sided 95% confidence interval for the slope was computed. Perfect dose proportionality would correspond to a slope of 1. Standard error of the mean is actually standard error of the slope.|Dose proportionality for AUCτ,ss was explored based on the regression model.||1.3666|0.5934|
72392981|NCT02615145|144293544|SUPERIORITY||difference in LS means|-3.67||||0.4256|TWO_SIDED|95.0|-12.7|5.39||Between group change comparison: 3DAA - 2DAA+RBV. The dependent variable in the change of FACIT-F \[0-100\] from Baseline (Visit-Baseline). The analysis is adjusted for Baseline.|ANCOVA|||48 weeks after EoT||5.39|-12.7|0.4256
72392982|NCT02615145|144293544|SUPERIORITY||difference in LS means|-3.01||||0.5347|TWO_SIDED|95.0|-12.6|6.54||Between group change comparison: 3DAA+RBV - 2DAA+RBV. The dependent variable in the change of FACIT-F \[0-100\] from Baseline (Visit-Baseline). The analysis is adjusted for Baseline.|ANCOVA|||48 weeks after EoT||6.54|-12.6|0.5347
72392983|NCT02615145|144293544|SUPERIORITY||difference in LS means|0.654||||0.792|TWO_SIDED|95.0|-4.23|5.54||Between group change comparison: 3DAA+RBV - 3DAA. The dependent variable in the change of FACIT-F \[0-100\] from Baseline (Visit-Baseline). The analysis is adjusted for Baseline.|ANCOVA|||48 weeks after EoT||5.54|-4.23|0.7920
72392984|NCT02615145|144293544|SUPERIORITY||Mean Difference (Final Values)|5.64|||<|0.0001|TWO_SIDED|95.0|3.355|7.935|||paired t-test|paired t-test of mean difference from 0||Baseline to EOT across all participants||7.935|3.355|< 0.0001
72462497|NCT03866434|144447677|EQUIVALENCE|90% CIs of geometric mean ratios being within 80% to 125%.|% ratio of Geometric LS means|86.504|||||TWO_SIDED|90.0|78.462|95.371|||ANOVA|A 2-factor analysis of variance (ANOVA) model with fixed factors for treatment and participant was fitted to the natural logtransformed PK parameters.|This analysis was performed based on the ratio of geometric LS means and 90% confidence interval for ratio of geometric means expressed as percent.|The means of the log-transformed pharmacokinetic parameters were compared between the two treatments (anagrelide with omeprazole \[Day 8\] versus anagrelide alone \[Day 1\]). In order to estimate the magnitude of the treatment regimen differences, the geometric mean ratio (i.e., the LS mean difference in the log-transformed parameters back transformed to the original scale) and their 90% CI were calculated.||95.371|78.462|
72501921|NCT01309737|144533711|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.46|STANDARD_ERROR_OF_MEAN|0.53|<|0.0001|TWO_SIDED|95.0|-5.51|-3.42||Mixed model analysis with fixed effects for treatment, visit, treatment-by-visit interaction,baseline value and repeated measures for visit. Unstructured covariance matrix was used. Each hypothesis was tested at significance level of 0.025 (2-sided).|Mixed Models Analysis|||Week 16: For key secondary endpoint, family-wise step-down procedure was used to control Type I error. Sequential order of testing: percent change in BSA at Week 16, PASI90 response at Week 16, change in DLQI total score at Week 16, PGA response at Week 4, PASI75 response at Week 4, change in DLQI total score at Week 4, percent change in NAPSI score at Week 16. If comparison at preceding step was significant, then subsequent comparisons were significant.||-3.42|-5.51|<0.0001
72462498|NCT00385697|144447688|SUPERIORITY||Odds Ratio (OR)|0.963||||0.904|TWO_SIDED|95.0|0.521|1.779|||Mantel Haenszel|||||1.779|0.521|0.904
72462499|NCT00385697|144447688|SUPERIORITY||Odds Ratio (OR)|0.629||||0.222|TWO_SIDED|95.0|0.297|1.33|||Mantel Haenszel|||||1.330|0.297|0.222
72462500|NCT00385697|144447688|SUPERIORITY||Odds Ratio (OR)|1.054||||0.885|TWO_SIDED|95.0|0.521|2.129|||Mantel Haenszel|||||2.129|0.521|0.885
72501922|NCT01309737|144533711|SUPERIORITY_OR_OTHER||LS Mean Difference|-6.1|STANDARD_ERROR_OF_MEAN|0.53|<|0.0001|TWO_SIDED|95.0|-7.14|-5.05||Mixed model analysis with fixed effects for treatment, visit, treatment-by-visit interaction,baseline value and repeated measures for visit. Unstructured covariance matrix was used. Each hypothesis was tested at significance level of 0.025 (2-sided).|Mixed Models Analysis|||Week 16: For key secondary endpoint, family-wise step-down procedure was used to control Type I error.Sequential order of testing: percent change in BSA at Week 16, PASI90 response at Week 16, change in DLQI total score at Week 16, PGA response at Week 4, PASI75 response at Week 4, change in DLQI total score at Week 4, percent change in NAPSI score at Week 16. If comparison at preceding step was significant, then subsequent comparisons were significant.||-5.05|-7.14|<0.0001
72501923|NCT01309737|144533711|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.63|STANDARD_ERROR_OF_MEAN|0.43||0.0002|TWO_SIDED|95.0|-2.48|-0.79|||Mixed Models Analysis|||Week 16: LS mean difference was derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction, baseline value and repeated measures for visit. Unstructured covariance matrix was used.||-0.79|-2.48|0.0002
72501924|NCT01309737|144533712|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.63|||<|0.0001|TWO_SIDED|95.0|1.89|8.95||Cochran-Mantel-Haenszel statistics adjusted for pooled investigator sites was used for the analysis. Each hypothesis was tested at significance level of 0.025 (2-sided).|Cochran-Mantel-Haenszel|||For key secondary endpoint, family-wise step-down procedure was used to control Type I error. Sequential order of testing: percent change in BSA at Week 16, PASI90 response at Week 16, change in DLQI total score at Week 16, PGA response at Week 4, PASI75 response at Week 4, change in DLQI total score at Week 4, percent change in NAPSI score at Week 16. If comparison at preceding step was significant, then subsequent comparisons were significant.||8.95|1.89|<.0001
72563683|NCT02792218|144658699|SUPERIORITY||Hazard Ratio (HR)|1.355||||0.092|TWO_SIDED|95.0|0.952|1.952|||Regression, Cox|||This study was not powered for the analysis of this endpoint individually. It was pre-specified in the study protocol to combine the data from this study with study COMB157G2302 to address this endpoint.||1.952|0.952|0.092
72392985|NCT02615145|144293544|SUPERIORITY||Mean Difference (Final Values)|10.21|||<|0.0001|TWO_SIDED|95.0|8.113|12.299|||paired t-test|paired t-test of mean difference versus 0||Baseline vs 12 weeks after EOT across all participants||12.299|8.113|< 0.0001
72392986|NCT02615145|144293544|SUPERIORITY||Mean Difference (Final Values)|10.13|||<|0.0001|TWO_SIDED|95.0|7.259|12.992|||paired t-test|paired t-test of mean difference versus 0||baseline vs 48 weeks after EOT across all participants||12.992|7.259|< 0.0001
72392987|NCT02615145|144293545|SUPERIORITY|||||||0.3869||||||Between group change comparison: overall. The dependent variable in the change of PAM-13 from Baseline (Visit-Baseline). The analysis is adjusted for Baseline.|ANCOVA|||||||0.3869
72392988|NCT02615145|144293545|SUPERIORITY||difference in LS means|-1.89||||0.3125|TWO_SIDED|95.0|-5.57|1.79||Between group change comparison: 3DAA - 2DAA+RBV. The dependent variable in the change of PAM-13 from Baseline (Visit-Baseline). The analysis is adjusted for Baseline.|ANCOVA|||||1.79|-5.57|0.3125
72462501|NCT00385697|144447690|SUPERIORITY||Mean Difference (Final Values)|0.061||||0.814|TWO_SIDED|95.0|-0.45|0.572|||ANCOVA|||||0.572|-0.450|0.814
72462502|NCT00385697|144447690|SUPERIORITY||Mean Difference (Final Values)|0.161||||0.593|TWO_SIDED|95.0|-0.433|0.755|||ANCOVA|||||0.755|-0.433|0.593
72462503|NCT00385697|144447690|SUPERIORITY||Mean Difference (Final Values)|-0.4||||0.886|TWO_SIDED|95.0|-0.594|0.513|||ANCOVA|||||0.513|-0.594|0.886
72462504|NCT00385697|144447692|SUPERIORITY||Mean Difference (Final Values)|0.047||||0.049|TWO_SIDED|95.0|0.0|0.093|||ANCOVA|||||0.093|0.000|0.049
72462505|NCT00385697|144447692|SUPERIORITY||Mean Difference (Final Values)|-0.002||||0.937|TWO_SIDED|95.0|-0.061|0.056|||ANCOVA|||||0.056|-0.061|0.937
72501925|NCT01309737|144533712|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|8.25|||<|0.0001|TWO_SIDED|95.0|4.08|19.95||Cochran-Mantel-Haenszel statistics adjusted for pooled investigator sites was used for the analysis. Each hypothesis was tested at significance level of 0.025 (2-sided).|Cochran-Mantel-Haenszel|||For key secondary endpoint, family-wise step-down procedure was used to control Type I error. Sequential order of testing: percent change in BSA at Week 16, PASI90 response at Week 16, change in DLQI total score at Week 16, PGA response at Week 4, PASI75 response at Week 4, change in DLQI total score at Week 4, percent change in NAPSI score at Week 16. If comparison at preceding step was significant, then subsequent comparisons were significant.||19.95|4.08|<.0001
72501926|NCT01309737|144533712|SUPERIORITY_OR_OTHER||Percent difference|10.79|STANDARD_ERROR_OF_MEAN|3.02||0.0004|TWO_SIDED|95.0|4.87|16.71|||Normal Approximation|||||16.71|4.87|0.0004
72501927|NCT01309737|144533713|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.72||||0.1786|TWO_SIDED|95.0|0.74|4.62||Cochran-Mantel-Haenszel statistics adjusted for pooled investigator sites was used for the analysis. Each hypothesis was tested at significance level of 0.025 (2-sided).|Cochran-Mantel-Haenszel|||For key secondary endpoint, family-wise step-down procedure was used to control Type I error. Sequential order of testing: percent change in BSA at Week 16, PASI90 response at Week 16, change in DLQI total score at Week 16, PGA response at Week 4, PASI75 response at Week 4, change in DLQI total score at Week 4, percent change in NAPSI score at Week 16. If comparison at preceding step was significant, then subsequent comparisons were significant.||4.62|0.74|0.1786
72501928|NCT01309737|144533713|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.18||||0.0003|TWO_SIDED|95.0|1.77|10.25||Cochran-Mantel-Haenszel statistics adjusted for pooled investigator sites was used for the analysis. Each hypothesis was tested at significance level of 0.025 (2-sided).|Cochran-Mantel-Haenszel|||For key secondary endpoint, family-wise step-down procedure was used to control Type I error.Sequential order of testing: percent change in BSA at Week 16, PASI90 response at Week 16, change in DLQI total score at Week 16, PGA response at Week 4, PASI75 response at Week 4, change in DLQI total score at Week 4, percent change in NAPSI score at Week 16. If comparison at preceding step was significant, then subsequent comparisons were significant.||10.25|1.77|0.0003
72501929|NCT01309737|144533713|SUPERIORITY_OR_OTHER||Percent Difference|6.72|STANDARD_ERROR_OF_MEAN|2.26||0.0029|TWO_SIDED|95.0|2.3|11.14|||Normal Approximation|||||11.14|2.30|0.0029
72501930|NCT01309737|144533714|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|9.06|||<|0.0001|TWO_SIDED|95.0|5.02|16.45||Cochran-Mantel-Haenszel statistics adjusted for pooled investigator sites was used for the analysis. Each hypothesis was tested against placebo at significance level of 0.05 (2-sided).|Cochran-Mantel-Haenszel|||For primary endpoint, step-down procedure used to preserve Type I error, sequential order of testing: PGA response for CP-690,550 10 mg versus (vs) placebo at Week 16; Psoriasis Area and Severity Index 75 (PASI75) response for CP-690,550 10 mg vs placebo at Week 16; PGA response for CP-690,550 5 mg vs placebo at Week 16; PASI75 response for CP-690,550 5 mg vs placebo at Week 16. If comparison at preceding step was significant, only then subsequent comparisons were significant.||16.45|5.02|<0.0001
72501931|NCT01309737|144533714|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|17.97|||<|0.0001||95.0|9.0|30.73||Cochran-Mantel-Haenszel statistics adjusted for pooled investigator sites was used for the analysis. Each hypothesis was tested against placebo at significance level of 0.05 (2-sided).|Cochran-Mantel-Haenszel|||For primary endpoint, step-down procedure used to preserve Type I error, sequential order of testing: PGA response for CP-690,550 10 mg versus (vs) placebo at Week 16; Psoriasis Area and Severity Index 75 (PASI75) response for CP-690,550 10 mg vs placebo at Week 16; PGA response for CP-690,550 5 mg vs placebo at Week 16; PASI75 response for CP-690,550 5 mg vs placebo at Week 16. If comparison at preceding step was significant, only then subsequent comparisons were significant.||30.73|9.00|<0.0001
72501932|NCT01309737|144533714|SUPERIORITY_OR_OTHER||Percent difference|13.62||||0.0002|TWO_SIDED|95.0|6.54|20.69|||Normal Approximation|||||20.69|6.54|0.0002
72501933|NCT01309737|144533715|SUPERIORITY_OR_OTHER||LS Mean Difference|-37.44|STANDARD_ERROR_OF_MEAN|13.62||0.0062|TWO_SIDED|95.0|-64.19|-10.68||Mixed model analysis with fixed effects for treatment, visit, treatment-by-visit interaction,baseline value and repeated measures for visit. Unstructured covariance matrix was used. Each hypothesis was tested at significance level of 0.025 (2-sided).|Mixed Models Analysis|||For key secondary endpoint, family-wise step-down procedure was used to control Type I error. Sequential order of testing: percent change in BSA at Week 16, PASI90 response at Week 16, change in DLQI total score at Week 16, PGA response at Week 4, PASI75 response at Week 4, change in DLQI total score at Week 4, percent change in NAPSI score at Week 16. If comparison at preceding step was significant, then subsequent comparisons were significant.||-10.68|-64.19|0.0062
72501934|NCT01309737|144533715|SUPERIORITY_OR_OTHER||LS Mean Difference|-41.79|STANDARD_ERROR_OF_MEAN|13.75||0.0025|TWO_SIDED|95.0|-68.8|-14.78||Mixed model analysis with fixed effects for treatment, visit, treatment-by-visit interaction,baseline value and repeated measures for visit. Unstructured covariance matrix was used. Each hypothesis was tested at significance level of 0.025 (2-sided).|Mixed Models Analysis|||For key secondary endpoint, family-wise step-down procedure was used to control Type I error. Sequential order of testing: percent change in BSA at Week 16, PASI90 response at Week 16, change in DLQI total score at Week 16, PGA response at Week 4, PASI75 response at Week 4, change in DLQI total score at Week 4, percent change in NAPSI score at Week 16. If comparison at preceding step was significant, then subsequent comparisons were significant.||-14.78|-68.80|0.0025
72563684|NCT02792218|144658700|SUPERIORITY||Hazard Ratio (HR)|1.186||||0.516|TWO_SIDED|95.0|0.709|1.983|||Regression, Cox|||This study was not powered for the analysis of this endpoint individually. It was pre-specified in the study protocol to combine the data from this study with study COMB157G2302 to address this endpoint.||1.983|0.709|0.516
72563685|NCT02792218|144658701|SUPERIORITY||rate ratio|0.025|||<|0.001|TWO_SIDED|95.0|0.013|0.049|||negative binomial regression model|||||0.049|0.013|<.001
72563686|NCT02792218|144658702|SUPERIORITY||rate ratio|0.26|||<|0.001|TWO_SIDED|95.0|0.21|0.33|||negative binomial regression model|||Month 12||0.33|0.21|<.001
72563687|NCT02792218|144658702|SUPERIORITY||rate ratio|0.22|||<|0.001|TWO_SIDED|95.0|0.15|0.34|||negative binomial regression model|||Month 24||0.34|0.15|<.001
72563688|NCT02792218|144658702|SUPERIORITY||rate ratio|0.18|||<|0.001|TWO_SIDED|95.0|0.15|0.22|||negative binomial regression model|||End of Study||0.22|0.15|<.001
72563689|NCT02792218|144658703|SUPERIORITY||Geo-mean ratio|0.93||||0.011|TWO_SIDED|95.0|0.89|0.98|||Mixed Models Analysis|Mixed Models for Repeated Measures (MMRM)||Month 3||0.98|0.89|0.011
72563690|NCT02792218|144658703|SUPERIORITY||Geo-mean ratio|0.73|||<|0.001|TWO_SIDED|95.0|0.69|0.77|||Mixed Models Analysis|Mixed Models for Repeated Measures (MMRM)||Month 12||0.77|0.69|<.001
72563691|NCT02792218|144658703|SUPERIORITY||Geo-mean ratio|0.77|||<|0.001|TWO_SIDED|95.0|0.72|0.82|||Mixed Models Analysis|Mixed Models for Repeated Measures (MMRM)||Month 24||0.82|0.72|<.001
72563692|NCT02792218|144658704|SUPERIORITY||Mean Difference (Net)|0.07||||0.118|TWO_SIDED|95.0|-0.02|0.15|||random coefficient model|||||0.15|-0.02|0.118
72563693|NCT02792218|144658707|SUPERIORITY||Hazard Ratio (HR)|0.641||||0.002|TWO_SIDED|95.0|0.486|0.847|||Regression, Cox|||||0.847|0.486|0.002
72621124|NCT02732145|144773181|EQUIVALENCE|Question: Is there a difference in the incidence of vulvar soreness among patients with vulvar discomfort?||||||0.0076|||||||Chi-squared|||Parameter: The difference in the incidence of vulvar soreness among patients with vulvar discomfort.||||0.0076
72621125|NCT02732145|144773181|EQUIVALENCE|Question: Is there a difference in the incidence of irritation of the vulva among the patients with vulvar discomfort?||||||0.0423|||||||Chi-squared|||Parameter: The difference in the incidence of irritation of the vulva among patients with vulvar discomfort.||||0.0423
72462506|NCT00385697|144447692|SUPERIORITY||Mean Difference (Final Values)|0.026||||0.382|TWO_SIDED|95.0|-0.032|0.084|||ANCOVA|||||0.084|-0.032|0.382
72462507|NCT00385697|144447694|SUPERIORITY||Odds Ratio (OR)|0.881||||0.775|TWO_SIDED|95.0|0.372|2.089|||Mantel Haenszel|||||2.089|0.372|0.775
72462508|NCT00385697|144447694|SUPERIORITY||Odds Ratio (OR)|0.628||||0.402|TWO_SIDED|95.0|0.212|1.861|||Mantel Haenszel|||||1.861|0.212|0.402
72462509|NCT00385697|144447694|SUPERIORITY||Odds Ratio (OR)|1.093||||0.859|TWO_SIDED|95.0|0.41|2.912|||Mantel Haenszel|||||2.912|0.410|0.859
72462510|NCT00385697|144447696|SUPERIORITY||Odds Ratio (OR)|1.265||||0.404|TWO_SIDED|95.0|0.727|2.2|||Mantel Haenszel|||||2.200|0.727|0.404
72462511|NCT00385697|144447696|SUPERIORITY||Odds Ratio (OR)|0.805||||0.528|TWO_SIDED|95.0|0.412|1.576|||Mantel Haenszel|||||1.576|0.412|0.528
72563694|NCT02792218|144658708|SUPERIORITY||Hazard Ratio (HR)|0.657||||0.008|TWO_SIDED|95.0|0.481|0.898|||Regression, Cox|||||0.898|0.481|0.008
72563695|NCT01745952|144658727|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9819|TWO_SIDED||||||negative binomial model + overdispersion|||||||0.9819
72563696|NCT06442410|144658758|SUPERIORITY||||||<|0.0001|||||||Chi-squared|||||||<0.0001
72462512|NCT00385697|144447696|SUPERIORITY||Odds Ratio (OR)|1.133||||0.706|TWO_SIDED|95.0|0.594|2.164|||Mantel Haenszel|||||2.164|0.594|0.706
72462513|NCT00385697|144447698|SUPERIORITY||Mean Difference (Final Values)|0.04||||0.872|TWO_SIDED|95.0|-0.455|0.536|||ANCOVA|||||0.536|-0.455|0.872
72462514|NCT00385697|144447698|SUPERIORITY||Mean Difference (Final Values)|-0.008||||0.979|TWO_SIDED|95.0|-0.581|0.556|||ANCOVA|||||0.556|-0.581|0.979
72462515|NCT00385697|144447698|SUPERIORITY||Mean Difference (Final Values)|-0.225||||0.4|TWO_SIDED|95.0|-0.75|0.301|||ANCOVA|||||0.301|-0.750|0.400
72462516|NCT01485991|144447700|SUPERIORITY_OR_OTHER||Difference in proportions|-1.1||||0.001|TWO_SIDED|95.0|-7.8|5.5||based on the asymptotic distribution of the generalized Cochran-Mantel-Haenszel statistic controlling for stratification factors, using a non-inferiority margin of 12 percent|Stratified Cochran-Mantel-Haenszel|||||5.5|-7.8|0.001
72462517|NCT01209936|144447842|SUPERIORITY|||||||0.87|||||||t-test, 2 sided|||||||0.87
72462518|NCT01209936|144447843|SUPERIORITY|||||||0.17|||||||t-test, 2 sided|||||||0.17
72462519|NCT01209936|144447844|SUPERIORITY|||||||0.55|||||||t-test, 2 sided|||||||0.55
72462520|NCT00832650|144447866|SUPERIORITY_OR_OTHER||LS Mean difference|0.051|||||TWO_SIDED|95.0|-0.334|0.436|||ANCOVA||Least squares mean was calculated based on the ANCOVA model with treatment group as a fixed effect and baseline values, age and Body Mass Index (BMI) as covariates.|Null H10: μF8mg=μS10mg where μF8mg and μS10mg are means of GC24 for fesoterodine 8mg and solifenacin 10mg, respectively.||0.436|-0.334|
72462521|NCT00257556|144447962|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.045||||||95.0|-0.17|0.26|||||A two-sided 95% continuity-corrected confidence interval for the difference in percentages, based on the normal approximation|||0.260|-0.170|
72462522|NCT04839289|144447988|OTHER||||||>|0.05||||||When p-value is adjusted for multiple comparisons, the level of statistical significance must be \</= to .01666667 (.05/3)|t-test, 2 sided|||"Null hypothesis: Subjective ratings of sound quality would not be different between any of the three study hearing aids when measured with a validated sound quality questionnaire.~Analysis was done after all three home trials completed so all three sets of study devices could be compared."||||>0.05
72563697|NCT06442410|144658759|SUPERIORITY||||||<|0.0001|||||||Chi-squared|||||||<0.0001
72563698|NCT06442410|144658760|SUPERIORITY||||||<|0.0001|||||||Chi-squared|||||||<0.0001
72621126|NCT02732145|144773181|EQUIVALENCE|Question: Is there a difference in the incidence of the knife-like pain in the vulva among the patients with vulvar discomfort?||||||0.0457|||||||Chi-squared|||Parameter: The difference in the incidence of the knife-like pain in the vulva among patients with vulvar discomfort.||||0.0457
72621127|NCT02732145|144773181|EQUIVALENCE|Question: Is there a difference in the incidence of the paper-cuts pain of the vulva among the patients with vulvar discomfort?||||||0.043|||||||Chi-squared|||Parameter: The difference in the incidence of the paper-cuts pain of the vulva among patients with vulvar discomfort.||||0.0430
72462523|NCT04839289|144447988|OTHER||||||<|0.0167||||||When p-value is adjusted for multiple comparisons, the level of statistical significance must be \</= to .01666667 (.05/3)|t-test, 2 sided|||"Null hypothesis: Subjective ratings of sound quality would not be different between any of the three study hearing aids when measured with a validated sound quality questionnaire.~Analysis was done after all three home trials completed so all three sets of study devices could be compared."||||<.0167
72462524|NCT04839289|144447991|OTHER||||||<|0.01666667||||||When p-value is adjusted for multiple comparisons, the value must be \</= to .01666667 (.05/3).|t-test, 2 sided|||"Null hypothesis: Satisfaction with hearing aid performance and features would not be different between any of the three study hearing aids when measured with subjective hearing aid satisfaction questionnaire.~Analysis was done after all three home trials completed so all three sets of study devices could be compared."||||<.01666667
72462525|NCT04839289|144447991|OTHER||||||<|0.01666667||||||When adjusted for multiple comparisons, the p-value must be \</= to .01666667 (.05/3).|t-test, 2 sided|||"Null hypothesis: Satisfaction with hearing aid performance and features would not be different between any of the three study hearing aids when measured with subjective hearing aid satisfaction questionnaire.~Analysis was done after all three home trials completed so all three sets of study devices could be compared."||||<.01666667
72462526|NCT02418819|144448005|SUPERIORITY_OR_OTHER||LSMean difference from placebo|-1.9|STANDARD_ERROR_OF_MEAN|2.032||0.8243|ONE_SIDED|92.0|-4.78||||ANCOVA|One(1)-sided P-values were obtained from an ANCOVA model on change from baseline with baseline, treatment, site, gender and age as fixed effects.||Baseline is defined as the Day -2 assessment.|||-4.78|0.8243
72462527|NCT02418819|144448005|SUPERIORITY_OR_OTHER||LSMean difference from placebo|-2.14|STANDARD_ERROR_OF_MEAN|2.252||0.8277|ONE_SIDED|92.0|-5.33||||ANCOVA|One(1)-side P-values were obtained from an ANCOVA model on change from baseline with baseline, treatment, site, gender and age as fixed effects.||Baseline is defined as the Day -2 assessment.|||-5.33|0.8277
72462528|NCT02418819|144448005|SUPERIORITY_OR_OTHER||LSMean difference from placebo|-4.01|STANDARD_ERROR_OF_MEAN|1.902||0.981|ONE_SIDED|92.0|-6.7||||ANCOVA|One(1)-side P-values were obtained from an ANCOVA model on change from baseline with baseline, treatment, site, gender and age as fixed effects.||Baseline is defined as the Day -2 assessment.|||-6.70|0.9810
72462529|NCT02418819|144448006|SUPERIORITY_OR_OTHER||LSMean difference from placebo|0.0129|STANDARD_ERROR_OF_MEAN|0.286||0.4821|ONE_SIDED|99.0|-0.6682||||ANCOVA|One (1)-side P-values were obtained from an ANCOVA model on change from baseline with baseline, treatment, site, gender and age as fixed effects.||Baseline is defined as the Day 0 assessment.|||-0.6682|0.4821
72462530|NCT02418819|144448006|SUPERIORITY_OR_OTHER||LSMean difference from placebo|-0.2974|STANDARD_ERROR_OF_MEAN|0.276||0.8576|ONE_SIDED|99.0|-0.9547||||ANCOVA|One (1)-side P-values were obtained from an ANCOVA model on change from baseline with baseline, treatment, site, gender and age as fixed effects.||Baseline is defined as the Day 0 assessment.|||-0.9547|0.8576
72462531|NCT02418819|144448006|SUPERIORITY_OR_OTHER||LSMean difference from placebo|0.0498|STANDARD_ERROR_OF_MEAN|0.2403||0.4182|ONE_SIDED|99.0|-0.5226||||ANCOVA|One(1)-side P-values were obtained from an ANCOVA model on change from baseline with baseline, treatment, site, gender and age as fixed effects.||Baseline is defined as the Day 0 assessment.|||-0.5226|0.4182
72462532|NCT00580047|144448019|OTHER||||||||||||||||||The intervention groups were compared for compliance to either having annual IV zoledronic acid, taking weekly oral alendronate, and taking calcium/vitamin D supplementation.|||
72462533|NCT04382053|144448020|SUPERIORITY||Least squares mean difference|0.11|STANDARD_ERROR_OF_MEAN|1.297||0.467|TWO_SIDED|90.0|-2.0|2.3|||ANCOVA|||||2.3|-2.0|0.467
72462534|NCT04382053|144448021|SUPERIORITY|||||||0.237||||||One-sided|Mixed Models Analysis|p-value reported is for the treatment factor across all time points||||||0.237
72462535|NCT00924833|144448025|SUPERIORITY_OR_OTHER|||||||0.01||||||"Within subjects effects. Time: P \< 0.01. Time \* treatment: P=0.25~Bonferroni correction. Within the placebo, carvedilol and nebivolol group, p \< 0.01 for Time 3 - Time 1, and Time 3 - Time 2."|ANOVA|||"Differences among groups, changes over time and interactions: two-way repeated measures ANOVA with unpaired Student's t-test, Bonferroni correction.~No previous studies have compared carvedilol, nebivolol, and placebo with respecto to exercise performance in hypobaric hypoxia. The sample size set for each treatment arm was defined on the basis of the sample size of previous investigations showing significant changes in exercise performance in normal subjects."||||0.01
72563699|NCT06442410|144658761|SUPERIORITY||||||<|0.0001|||||||Chi-squared|||||||<0.0001
72462536|NCT00924833|144448026|SUPERIORITY_OR_OTHER||||||<|0.05||||||P \< 0.05. Bonferroni correction: p \< 0.05 nebivolol versus carvedilol|ANOVA|||No previous studies have compared carvedilol, nebivolol, and placebo with respecto to exercise performance in hypobaric hypoxia. The sample size set for each treatment arm was defined on the basis of the sample size of previous investigations showing significant changes in exercise performance in normal subjects.||||<0.05
72563700|NCT06442410|144658762|SUPERIORITY||||||<|0.0001|||||||Chi-squared|||||||<0.0001
72462537|NCT00924833|144448027|SUPERIORITY_OR_OTHER|||||||0.93||||||Within subjects effects. Time: p = 0.03. Time \* treatment: p = 0.12.|ANOVA|||"Differences among groups, changes over time and interactions: two-way repeated measures ANOVA with unpaired Student's t-test, Bonferroni correction.~No previous studies have compared carvedilol, nebivolol, and placebo with respecto to exercise performance in hypobaric hypoxia. The sample size set for each treatment arm was defined on the basis of the sample size of previous investigations showing significant changes in exercise performance in normal subjects."||||0.93
72462538|NCT00924833|144448030|SUPERIORITY_OR_OTHER||||||<|0.05||||||ANOVA with unpaired Student's t-test, Bonferroni correction. Bonferroni correction. p = 0.05.|ANOVA|||No previous studies have compared carvedilol, nebivolol, and placebo with respecto to exercise performance in hypobaric hypoxia. The sample size set for each treatment arm was defined on the basis of the sample size of previous investigations showing significant changes in exercise performance in normal subjects.||||<0.05
72462539|NCT00390806|144448034|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.88||||0.1862|TWO_SIDED|95.0|0.73|1.07||p-value from a stratified log-rank test is adjusted for Recursive Partitioning Analysis (RPA) class and the number of brain lesions at Screening.|Log Rank||The hazard ratio is estimated using a Pike estimator. The hazard ratio from a stratified log-rank test is adjusted for RPA class and the number of brain lesions at Screening.|||1.07|0.73|0.1862
72563701|NCT06442410|144658763|SUPERIORITY||||||<|0.0001|||||||Chi-squared|||||||<0.0001
72563702|NCT06442410|144658765|NON_INFERIORITY|A non-inferiority margin of 0.65 cm was selected based on a previous study of a similar therapy against traditional SCS.|||||<|0.0001|||||||Chi-squared|||||||<0.0001
72462540|NCT00513292|144448066|SUPERIORITY_OR_OTHER||difference in percentages between arms|2.3||||0.7|TWO_SIDED|95.0|-9.3|13.9|||Chi-squared|||The difference in pCR rates between treatment arms for pCR within the Breast, Defined as no Evidence of Invasive Tumor Remaining in the Breast at Surgery Following Completion of Chemotherapy||13.9|-9.3|.7
72469771|NCT00121667|144463380|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.73|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001|TWO_SIDED|95.0|-0.92|-0.53||Between-group comparisons significant at alpha = 0.019, significance testing based on hierarchical testing. Primary and secondary endpoints are presented in order of testing.|ANCOVA|Adjusted mean difference for saxagliptin groups vs placebo in Week 24 (LOCF). Adjusted for baseline.|ANCOVA model: difference between week t and baseline values = baseline values + treatment|||-0.53|-0.92|<.0001
72469772|NCT00121667|144463380|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.83|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001|TWO_SIDED|95.0|-1.02|-0.63||Between-group comparisons significant at alpha = 0.019, significance testing based on hierarchical testing. Primary and secondary endpoints are presented in order of testing.|ANCOVA|Adjusted mean difference for saxagliptin groups vs placebo in Week 24 (LOCF). Adjusted for baseline.|ANCOVA model: difference between week t and baseline values = baseline values + treatment|||-0.63|-1.02|<.0001
72469773|NCT00121667|144463380|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.72|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001|TWO_SIDED|95.0|-0.91|-0.52||Between-group comparisons significant at alpha = 0.019, significance testing based on hierarchical testing. Primary and secondary endpoints are presented in order of testing.|ANCOVA|Adjusted mean difference for saxagliptin groups vs placebo in Week 24 (LOCF) .Adjusted for baseline.|ANCOVA model: difference between week t and baseline values = baseline values + treatment|||-0.52|-0.91|<.0001
72469774|NCT00121667|144463381|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.55|STANDARD_ERROR_OF_MEAN|3.56|<|0.0001|TWO_SIDED|95.0|-22.55|-8.55||Significance testing based on hierarchical testing. Primary and secondary endpoints are presented in order of testing.|ANCOVA|Adjusted mean difference for saxagliptin groups vs placebo in Week 24 (LOCF). Adjusted for baseline.|ANCOVA model: difference between week t and baseline values = baseline values + treatment|||-8.55|-22.55|<.0001
72469775|NCT00121667|144463381|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-23.28|STANDARD_ERROR_OF_MEAN|3.57|<|0.0001|TWO_SIDED|95.0|-30.29|-16.27||Significance testing based on hierarchical testing. Primary and secondary endpoints are presented in order of testing.|ANCOVA|Adjusted mean difference for saxagliptin groups vs placebo in Week 24 (LOCF) .Adjusted for baseline.|ANCOVA model: difference between week t and baseline values = baseline values + treatment|||-16.27|-30.29|<.0001
72469776|NCT00121667|144463381|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-21.74|STANDARD_ERROR_OF_MEAN|3.6|<|0.0001|TWO_SIDED|95.0|-28.81|-14.68||Significance testing based on hierarchical testing. Primary and secondary endpoints are presented in order of testing.|ANCOVA|Adjusted mean difference for saxagliptin groups vs placebo in Week 24 (LOCF) .Adjusted for baseline.|ANCOVA model: difference between week t and baseline values = baseline values + treatment|||-14.68|-28.81|<.0001
72469777|NCT00121667|144463382|SUPERIORITY_OR_OTHER||Difference in Proportions|20.5|||<|0.0001|TWO_SIDED|95.0|10.6|30.5||Significance testing based on hierarchical testing. Primary and secondary endpoints are presented in order of testing.|Fisher Exact|The exact 95% CIs is based on the standardized statistic and inverting the one 2-sided test.||||30.5|10.6|<.0001
72469778|NCT00121667|144463382|SUPERIORITY_OR_OTHER||Difference in Proportions|27.0|||<|0.0001|TWO_SIDED|95.0|17.0|36.7||Significance testing based on hierarchical testing. Primary and secondary endpoints are presented in order of testing.|Fisher Exact|The exact 95% CIs is based on the standardized statistic and inverting the one 2-sided test.||||36.7|17.0|<.0001
72469779|NCT00121667|144463382|SUPERIORITY_OR_OTHER||Difference in Proportions|27.9|||<|0.0001|TWO_SIDED|95.0|17.7|37.7||Significance testing based on hierarchical testing. Primary and secondary endpoints are presented in order of testing.|Fisher Exact|The exact 95% CIs is based on the standardized statistic and inverting the one 2-sided test.||||37.7|17.7|<.0001
72469780|NCT00121667|144463383|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5599.0|STANDARD_ERROR_OF_MEAN|1168.2|<|0.0001|TWO_SIDED|95.0|-7894.0|-3305.0||Significance testing based on hierarchical testing. Primary and secondary endpoints are presented in order of testing.|ANCOVA|Adjusted mean difference for saxagliptin groups vs placebo in Week 24 (LOCF). Adjusted for baseline.|ANCOVA model: difference between week t and baseline values = baseline values + treatment|||-3305|-7894|<.0001
72469781|NCT00121667|144463383|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6294.0|STANDARD_ERROR_OF_MEAN|1176.8|<|0.0001|TWO_SIDED|95.0|-8606.0|-3983.0||Significance testing based on hierarchical testing. Primary and secondary endpoints are presented in order of testing.|ANCOVA|Adjusted mean difference for saxagliptin groups vs placebo in Week 24 (LOCF). Adjusted for baseline.|ANCOVA model: difference between week t and baseline values = baseline values + treatment|||-3983|-8606|<.0001
72563703|NCT06442410|144658766|NON_INFERIORITY|A non-inferiority margin of 0.65 cm was selected based on a previous study of a similar therapy against traditional SCS|||||<|0.0001|||||||Chi-squared|||||||<0.0001
72469782|NCT00121667|144463383|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4845.0|STANDARD_ERROR_OF_MEAN|1175.1|<|0.0001|TWO_SIDED|95.0|-7153.0|-2537.0||Significance testing based on hierarchical testing. Primary and secondary endpoints are presented in order of testing.|ANCOVA|Adjusted mean difference for saxagliptin groups vs placebo in Week 24 (LOCF). Adjusted for baseline.|ANCOVA model: difference between week t and baseline values = baseline values + treatment|||-2537|-7153|<.0001
72563704|NCT06442410|144658767|NON_INFERIORITY|A non-inferiority margin of 0.65 cm was selected based on a previous study of a similar therapy against traditional SCS.|||||<|0.0001|||||||Chi-squared|||||||<0.0001
72469783|NCT01453023|144463415|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.2|||||TWO_SIDED|95.0|-8.8|0.4|||||Day 1 HR. The estimated value represents the treatment difference: FF/VI 100/25 µg minus FF 100 µg.|||0.4|-8.8|
72469784|NCT01453023|144463415|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.7|||||TWO_SIDED|95.0|-1.1|8.5|||||Day 14 HR. The estimated value represents the treatment difference: FF/VI 100/25 µg minus FF 100 µg.|||8.5|-1.1|
72469785|NCT01453023|144463416|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.2|||||TWO_SIDED|95.0|-4.4|6.7|||||Day 1 QTcF. The estimated value represents the treatment difference: FF/VI 100/25 µg minus FF 100 µg.|||6.7|-4.4|
72469786|NCT01453023|144463416|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|||||TWO_SIDED|95.0|-6.0|5.5|||||Day 14 QTcF. The estimated value represents the treatment difference: FF/VI 100/25 µg minus FF 100 µg.|||5.5|-6.0|
72462541|NCT00332488|144448105|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.08||||0.42|TWO_SIDED|95.0|-0.11|0.27|||ANCOVA|||ANCOVA fitting model change from baseline in A1c with fixed effects for treatment and pooled site and baseline A1c as a covariate||0.27|-0.11|0.420
72462542|NCT00332488|144448106|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.91|||<|0.001|TWO_SIDED|95.0|0.69|1.14|||ANCOVA|Type III||ANCOVA fitting model change from baseline in A1c with fixed effects for treatment and pooled site and baseline A1c as a covariate||1.14|0.69|< 0.001
72563705|NCT06442410|144658768|NON_INFERIORITY|A non-inferiority margin of 0.65 cm was selected based on a previous study of a similar therapy against traditional SCS|||||<|0.0001|||||||Chi-squared|||||||<0.0001
72563706|NCT06442410|144658769|NON_INFERIORITY|A non-inferiority margin of 0.65 cm was selected based on a previous study of a similar therapy against traditional SCS|||||<|0.0001|||||||Chi-squared|||||||<0.0001
72563707|NCT06442410|144658770|NON_INFERIORITY|A non-inferiority margin of 0.65 cm was selected based on a previous study of a similar therapy against traditional SCS|||||<|0.0001|||||||Chi-squared|||||||<0.0001
72621128|NCT02732145|144773181|EQUIVALENCE|Question: Is there a difference in the incidence of the stabbing of the vulva among the patients with vulvar discomfort?||||||0.0134|||||||Chi-squared|||Parameter: The difference in the incidence of the stabbing of the vulva among patients with vulvar discomfort.||||0.0134
72462543|NCT02983877|144448110|SUPERIORITY||||||<|0.001|||||||Friedman test|3 degrees of freedom||||||<0.001
72462544|NCT02983877|144448111|SUPERIORITY||||||<|0.001|||||||ANOVA|3 degrees of freedom||||||<0.001
72462545|NCT02983877|144448112|SUPERIORITY||||||<|0.001|||||||Friedman test|3 degrees of freedom||||||<0.001
72462546|NCT02983877|144448113|SUPERIORITY|||||||0.89|||||||ANOVA|2 degrees of freedom||||||0.89
72462547|NCT03721978|144448114|SUPERIORITY|Superiority was concluded if the one-sided p-value was \<0.025 and the corresponding lower bound of the 95% CI exceeded zero (0).|Difference in Percentage|28.6||||0.115|TWO_SIDED|95.0|-24.6|50.4|||Miettinen and Nurminen method|||||50.4|-24.6|0.115
72563708|NCT06442410|144658771|NON_INFERIORITY|A non-inferiority margin of 0.65 cm was selected based on a previous study of a similar therapy against traditional SCS|||||<|0.0001|||||||Chi-squared|||||||<0.0001
72563709|NCT04947150|144658772|SUPERIORITY|||||||0.255||||||The reported p-value reflects the change across time for the full (Wave 1) sample.|ANOVA|Repeated measures ANOVA were used.||||||.255
72621129|NCT02732145|144773181|EQUIVALENCE|Question: Is there a difference in the incidence of sticking of the vulva among the patients with vulvar discomfort?||||||0.0581|||||||Chi-squared|||Parameter: The difference in the incidence of sticking of the vulva among patients with vulvar discomfort.||||0.0581
72563710|NCT04947150|144658773|SUPERIORITY|||||||0.56||||||The reported p-value reflects the change across time for the full (Wave 1) sample.|ANOVA|Repeated measures ANOVA||||||.560
72563711|NCT04947150|144658774|SUPERIORITY|||||||0.319||||||The reported p-value reflects the change across time for the full (Wave 1) sample.|ANOVA|Repeated measures ANOVA||||||.319
72563712|NCT04947150|144658775|SUPERIORITY|||||||0.032||||||The reported p-value reflects the change across time for the full (Wave 1) sample.|ANOVA|Repeated measures ANOVA||||||.032
72563713|NCT04947150|144658776|SUPERIORITY|||||||0.044||||||The reported p-value reflects the change across time for the full (Wave 1) sample.|ANOVA|Repeated measures ANOVA||||||.044
72563714|NCT04947150|144658777|SUPERIORITY|||||||0.01||||||The reported p-value reflects the change across time for the full (Wave 1) sample.|ANOVA|Repeated Measures ANOVA||||||.010
72563715|NCT04947150|144658778|SUPERIORITY|||||||0.073||||||The reported p-value reflects the change across time for the full (Wave 1) sample.|ANOVA|Repeated measures ANOVA||||||.073
72462548|NCT03721978|144448119|SUPERIORITY|Superiority was concluded if the one-sided p-value was \<0.025 and the corresponding lower bound of the 95% CI exceeded zero (0).|Difference in Percentage|18.9||||0.001|TWO_SIDED|95.0|7.8|28.6|||Miettinen and Nurminen method|||||28.6|7.8|0.001
72462549|NCT03721978|144448120|OTHER||Difference in Percentage|13.1|||||TWO_SIDED|95.0|-37.7|46.0||||||||46.0|-37.7|
72462550|NCT03721978|144448121|OTHER||Difference in Percentage|12.6|||||TWO_SIDED|95.0|-0.8|24.5||||||||24.5|-0.8|
72462551|NCT03721978|144448122|OTHER||Difference in Percentage|38.1|||||TWO_SIDED|95.0|-15.7|59.5||||||||59.5|-15.7|
72462552|NCT03721978|144448123|OTHER||Difference in Percentage|27.9|||||TWO_SIDED|95.0|16.0|38.2||||||||38.2|16.0|
72462553|NCT03721978|144448124|OTHER||Difference in Percentage|13.1|||||TWO_SIDED|95.0|-37.7|46.0||||||||46.0|-37.7|
72462554|NCT03721978|144448125|OTHER||Difference in Percentage|17.6|||||TWO_SIDED|95.0|5.2|28.5||||||||28.5|5.2|
72462555|NCT03721978|144448126|OTHER||Difference in Percentage|28.6|||||TWO_SIDED|95.0|-24.6|50.4||||||||50.4|-24.6|
72462556|NCT03721978|144448127|OTHER||Difference in Percentage|20.3|||||TWO_SIDED|95.0|10.1|29.5||||||||29.5|10.1|
72462557|NCT03721978|144448128|OTHER||Difference in Percentage|1.2|||||TWO_SIDED|95.0|-31.2|50.5||||||||50.5|-31.2|
72462558|NCT03721978|144448129|OTHER||Difference in Percentage|5.3|||||TWO_SIDED|95.0|-6.0|17.9||||||||17.9|-6.0|
72462559|NCT03721978|144448130|OTHER||Difference in Percentage|-6.0|||||TWO_SIDED|95.0|-54.7|25.8||||||||25.8|-54.7|
72462560|NCT03721978|144448131|OTHER||Difference in Percentage|12.2|||||TWO_SIDED|95.0|1.1|21.9||||||||21.9|1.1|
72462561|NCT03721978|144448132|OTHER||Location Shift|449.0|||||TWO_SIDED|95.0|0.0|18224.0||||||Week 15: HPV-16 E7||18224.0|0.0|
72462562|NCT03721978|144448132|OTHER||Location Shift|0.0|||||TWO_SIDED|95.0|-18224.0|674.0||||||Week 36: HPV-16 E7||674.0|-18224.0|
72462563|NCT03721978|144448132|OTHER||Location Shift|4049.0|||||TWO_SIDED|95.0|224.0|18224.0||||||Week 15: HPV-18 E7||18224.0|224.0|
72462564|NCT03721978|144448132|OTHER||Location Shift|74.0|||||TWO_SIDED|95.0|-18000.0|6074.0||||||Week 36: HPV-18 E7||6074.0|-18000.0|
72462565|NCT03721978|144448133|OTHER||Location Shift|224.0|||||TWO_SIDED|95.0|224.0|674.0||||||Week 15: HPV-16 E7||674.0|224.0|
72621130|NCT02732145|144773181|EQUIVALENCE|Question: Is there a difference in the incidence of itching of the vulva among the patients with vulvar discomfort?||||||0.0002|||||||Chi-squared|||Parameter: The difference in the incidence of itching of the vulva among patients with vulvar discomfort.||||0.0002
72621131|NCT02732145|144773181|EQUIVALENCE|Question: Is there a difference in the incidence of the feeling of inflammation of the vulva among the patients with vulvar discomfort?|t-test proportion|0.0||||0.0852|TWO_SIDED||||||Chi-squared|||Parameter: The difference in the incidence of the feeling of inflammation of the vulva among patients with vulvar discomfort.||||0.0852
72392989|NCT02615145|144293545|SUPERIORITY||difference in LS means|-2.65||||0.1741|TWO_SIDED|95.0|-6.48|1.18||Between group change comparison: 3DAA+RBV - 2DAA+RBV. The dependent variable in the change of PAM-13 from Baseline (Visit-Baseline). The analysis is adjusted for Baseline.|ANCOVA|||||1.18|-6.48|0.1741
72392990|NCT02615145|144293545|SUPERIORITY||difference in LS means|-0.76||||0.4941|TWO_SIDED|95.0|-2.94|1.42||Between group change comparison: 3DAA+RBV - 3DAA. The dependent variable in the change of PAM-13 from Baseline (Visit-Baseline). The analysis is adjusted for Baseline.|ANCOVA|||||1.42|-2.94|0.4941
72392991|NCT02615145|144293545|SUPERIORITY||Mean Difference (Final Values)|-0.09||||0.8842|TWO_SIDED|95.0|-1.271|1.096|||paired t-test|paired t-test of mean difference vs 0||Change from Baseline to Final visit across all participants||1.096|-1.271|0.8842
72392992|NCT03727347|144293549|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|Hypothesis was that the improvement (decrease) in rTNSS mean score, from baseline to 12 weeks, would exceed 1 point||||||<0.0001
72392993|NCT03200860|144293555|SUPERIORITY|||||||0.18|||||||t-test, 2 sided|||||||0.18
72392994|NCT03200860|144293556|SUPERIORITY|||||||0.37|||||||t-test, 2 sided|||||||0.37
72392995|NCT03200860|144293557|SUPERIORITY|||||||0.58|||||||Wilcoxon (Mann-Whitney)|||||||0.58
72392996|NCT03200860|144293558|SUPERIORITY|||||||0.63|||||||t-test, 2 sided|||||||0.63
72392997|NCT03200860|144293559|SUPERIORITY|||||||0.31|||||||Regression, Logistic|||||||0.31
72392998|NCT03200860|144293560|SUPERIORITY|||||||0.014|||||||Regression, Logistic|||||||0.014
72392999|NCT00040937|144293568|SUPERIORITY_OR_OTHER||4-yr survival (%)|64.0|||||TWO_SIDED|95.0|55.0|74.0|||Kaplan and Meier|||The study was designed to have 82% power for detecting a 50% improvement in survival from a median of 4 years, as observed in SWOG S9321.||74|55|
72393000|NCT02324569|144293589|SUPERIORITY||Least square (LS) mean difference|-0.63|STANDARD_ERROR_OF_MEAN|0.097|<|0.0001|TWO_SIDED|95.0|-0.826|-0.443|||ANCOVA|||||-0.443|-0.826|<0.0001
72393001|NCT02016560|144293599|OTHER||Cox Proportional Hazard|1.581||||0.067|TWO_SIDED|95.0|0.968|2.581||A p-value of \<0.05 was the a priori threshold for statistical significance.|Cox proportional hazards|The Cox proportional hazard model was adjusted for baseline age, American National Adult Reading Test (ANART) score, and baseline CDR-SB score.||The specific hypothesis tested was that the hazard of progressing to the clinically meaningful event (defined as CDR-SB value change of at least 1 within 18 months) will be significantly greater for subjects with flortaucipir scans rated by majority interpretation as predicted to progress (Advanced AD scan pattern), as compared to subjects with scans rated as not predicted to progress (Moderate or Not AD scan pattern).||2.581|0.968|0.067
72393002|NCT02016560|144293600|OTHER||||||<|0.0001||||||No adjustment for multiple comparisons. No a priori threshold was set.|ANCOVA|Adjusted for age||ANCOVA model comparing the mean SUVr between AD and Older Cognitively Healthy within amyloid positive group.||||<0.0001
72393003|NCT02016560|144293600|OTHER|||||||0.0622||||||No adjustment for multiple comparisons. No a priori threshold was set.|ANCOVA|Adjusted for age||ANCOVA model comparing the mean SUVr between MCI and Older Cognitively Healthy within the amyloid positive group.||||0.0622
72393004|NCT02016560|144293600|OTHER||||||<|0.0001||||||No adjustment for multiple comparisons. No a priori threshold was set.|ANCOVA|Adjusted for age||ANCOVA model comparing the mean SUVr between AD and MCI within the amyloid positive group.||||<0.0001
72393005|NCT02016560|144293601|EQUIVALENCE|Test of whether the least squares mean change is significantly different than zero|||||<|0.0001|||||||Mixed Models Analysis|||SUVr change from baseline as dependent variable, baseline SUVr, age, and visit as independent variables, using an unstructured covariance structure for amyloid positive subjects only.||||<0.0001
72393006|NCT02016560|144293601|EQUIVALENCE|Test of whether the least squares mean change is significantly different than zero||||||0.7851|||||||Mixed Models Analysis|||SUVr change from baseline as dependent variable, baseline SUVr, age, and visit as independent variables, using an unstructured covariance structure for amyloid negative subjects only.||||0.7851
72393007|NCT02016560|144293602|OTHER||||||||||||||||||The hypothesis tested was that, of the 5 independent imaging physicians, at least 3 will have the lower bounds of 2-sided 95% confidence intervals ≥50%, for both sensitivity and specificity.|||
72393008|NCT02016560|144293603|OTHER||Pearson's correlation coefficient|-0.0925||||0.4361|TWO_SIDED||||||Pearson|||Pearson's correlation coefficient||||0.4361
72393009|NCT00911820|144293609|SUPERIORITY|||||||0.714|||||||Log Rank|||||||0.714
72393010|NCT00911820|144293611|SUPERIORITY|||||||0.605|||||||Fisher Exact|||||||0.605
72393011|NCT00911820|144293612|SUPERIORITY|||||||0.721|||||||Log Rank|||||||0.721
72393012|NCT01852110|144293613|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.18||||0.7623|TWO_SIDED|95.0|-1.0|1.37|||Constrained Longitudinal Data Analysis|||||1.37|-1.00|0.7623
72393013|NCT01852110|144293617|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.06||||0.9604|TWO_SIDED|95.0|-2.42|2.54|||Constrained Longitudinal Data Analysis|||||2.54|-2.42|0.9604
72393014|NCT01852110|144293618|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||0.0829|TWO_SIDED|95.0|-0.01|0.22|||Constrained Longitudinal Data Analysis|||||0.22|-0.01|0.0829
72462566|NCT03721978|144448133|OTHER||Location Shift|0.0|||||TWO_SIDED|95.0|0.0|24.0||||||Week 36: HPV-16 E7||24.0|0.0|
72462567|NCT03721978|144448133|OTHER||Location Shift|2024.0|||||TWO_SIDED|95.0|2024.0|6074.0||||||Week 15: HPV-18 E7||6074.0|2024.0|
72462568|NCT03721978|144448133|OTHER||Location Shift|674.0|||||TWO_SIDED|95.0|224.0|674.0||||||Week 36: HPV-18 E7||674.0|224.0|
72462569|NCT03721978|144448134|OTHER||Location Shift|25.0|||||TWO_SIDED|95.0|0.0|73.33||||||HPV-16 E6: Week 15||73.33|0.00|
72462570|NCT03721978|144448134|OTHER||Location Shift|15.0|||||TWO_SIDED|95.0|0.0|38.33||||||HPV-16 E6: Week 36||38.33|0.00|
72462571|NCT03721978|144448134|OTHER||Location Shift|16.67|||||TWO_SIDED|95.0|0.0|85.0||||||HPV-16 E7: Week 15||85.00|0.00|
72462572|NCT03721978|144448134|OTHER||Location Shift|5.0|||||TWO_SIDED|95.0|0.0|36.67||||||HPV-16 E7: Week 36||36.67|0.00|
72462573|NCT03721978|144448134|OTHER||Location Shift|26.67|||||TWO_SIDED|95.0|0.0|181.67||||||HPV-18 E6: Week 15||181.67|0.00|
72462574|NCT03721978|144448134|OTHER||Location Shift|11.67|||||TWO_SIDED|95.0|0.0|31.67||||||HPV-18 E6: Week 36||31.67|0.00|
72462575|NCT03721978|144448134|OTHER||Location Shift|3.33|||||TWO_SIDED|95.0|0.0|46.67||||||HPV-18 E7: Week 15||46.67|0.00|
72462576|NCT03721978|144448134|OTHER||Location Shift|4.17|||||TWO_SIDED|95.0|0.0|20.0||||||HPV-18 E7: Week 36||20.00|0.00|
72462577|NCT03721978|144448135|OTHER||Location Shift|8.33|||||TWO_SIDED|95.0|3.33|11.67||||||HPV-16 E6: Week 15||11.67|3.33|
72462578|NCT03721978|144448135|OTHER||Location Shift|5.83|||||TWO_SIDED|95.0|3.33|11.67||||||HPV-16 E6: Week 36||11.67|3.33|
72393015|NCT03462082|144293637|SUPERIORITY|||||||0.163||||||"Holm-adjusted P-Value: 0.326~\*Gait Velocity for Asymmetric STN-DBS 1 (right STN-DBS reduced) vs. Bilateral STN-DBS"|Mixed Models Analysis|||Bilateral (baseline) values are the average of the outcome measure data obtained during the 2 bilateral (baseline) conditions: 1) at enrollment before randomization and 2) after randomization. These average values are used to compare the changes associated with the 2 asymmetric conditions.||||0.163
72393016|NCT03462082|144293637|SUPERIORITY|||||||0.749||||||"Holm-adjusted P-Value: 0.749~\*Gait Velocity for Asymmetric STN-DBS 2 (left STN-DBS reduced) vs. Bilateral STN-DBS"|Mixed Models Analysis|||Bilateral (baseline) values are the average of the outcome measure data obtained during the 2 bilateral (baseline) conditions: 1) at enrollment before randomization and 2) after randomization. These average values are used to compare the changes associated with the 2 asymmetric conditions.||||0.749
72393017|NCT03462082|144293638|SUPERIORITY|||||||0.031||||||"Holm-adjusted P-Value: 0.155~\*MDS-UPDRS (total) for Asymmetric STN-DBS 1 (right STN-DBS reduced) vs. Bilateral STN-DBS"|Mixed Models Analysis|||Bilateral (baseline) values are the average of the outcome measure data obtained during the 2 bilateral (baseline) conditions: 1) at enrollment before randomization and 2) after randomization. These average values are used to report the changes associated with the 2 asymmetric conditions.||||0.031
72393018|NCT03462082|144293638|SUPERIORITY|||||||0.778||||||"Holm-adjusted P-Value: 0.902~\*MDS-UPDRS total for Asymmetric STN-DBS 2 (left STN-DBS reduced) vs. Bilateral STN-DBS"|Mixed Models Analysis|||Bilateral (baseline) values are the average of the outcome measure data obtained during the 2 bilateral (baseline) conditions: 1) at enrollment before randomization and 2) after randomization. These average values are used to report the changes associated with the 2 asymmetric conditions.||||0.778
72393019|NCT03462082|144293638|SUPERIORITY|||||||0.039||||||"Holm-adjusted P-Value: 0.157~\*MDS-UPDRS (motor) for Asymmetric STN-DBS 1 (right STN-DBS reduced) vs. Bilateral STN-DBS"|Mixed Models Analysis|||Bilateral (baseline) values are the average of the outcome measure data obtained during the 2 bilateral (baseline) conditions: 1) at enrollment before randomization and 2) after randomization. These average values are used to compare the changes associated with the 2 asymmetric conditions.||||0.039
72393020|NCT03462082|144293638|SUPERIORITY|||||||0.451||||||"Holm-adjusted P-Value: 0.902~\*MDS-UPDRS (motor) for Asymmetric STN-DBS 2 (left STN-DBS reduced) vs. Bilateral STN-DBS"|Mixed Models Analysis|||Bilateral (baseline) values are the average of the outcome measure data obtained during the 2 bilateral (baseline) conditions: 1) at enrollment before randomization and 2) after randomization. These average values are used to compare the changes associated with the 2 asymmetric conditions.||||0.451
72393021|NCT03462082|144293638|SUPERIORITY|||||||0.111||||||"Holm-adjusted P-Value: 0.333~\*MDS-UPDRS (axial motor) for Asymmetric STN-DBS 1 (right STN-DBS reduced) vs. Bilateral STN-DBS"|Mixed Models Analysis|||Bilateral (baseline) values are the average of the outcome measure data obtained during the 2 bilateral (baseline) conditions: 1) at enrollment before randomization and 2) after randomization. These average values are used to compare the changes associated with the 2 asymmetric conditions.||||0.111
72393022|NCT03462082|144293638|SUPERIORITY|||||||0.005||||||"Holm-adjusted P-Value: 0.030~\*MDS-UPDRS (axial motor) for Asymmetric STN-DBS 2 (left STN-DBS reduced) vs. Bilateral STN-DBS"|Mixed Models Analysis|||Bilateral (baseline) values are the average of the outcome measure data obtained during the 2 bilateral (baseline) conditions: 1) at enrollment before randomization and 2) after randomization. These average values are used to compare the changes associated with the 2 asymmetric conditions.||||0.005
72393023|NCT03462082|144293639|SUPERIORITY|||||||0.984||||||Asymmetric STN-DBS 1 (right STN-DBS reduced) vs. Bilateral STN-DBS|Mixed Models Analysis|||Bilateral (baseline) values are the average of the outcome measure data obtained during the 2 bilateral (baseline) conditions: 1) at enrollment before randomization and 2) after randomization. These average values are used to compare the changes associated with the 2 asymmetric conditions.||||0.984
72393024|NCT03462082|144293639|SUPERIORITY|||||||0.067||||||Asymmetric STN-DBS 2 (left STN-DBS reduced) vs. Bilateral STN-DBS|Mixed Models Analysis|||Bilateral (baseline) values are the average of the outcome measure data obtained during the 2 bilateral (baseline) conditions: 1) at enrollment before randomization and 2) after randomization. These average values are used to compare the changes associated with the 2 asymmetric conditions.||||0.067
72393025|NCT03462082|144293640|SUPERIORITY|||||||0.44||||||Asymmetric STN-DBS 1 (right STN-DBS reduced) vs. Bilateral STN-DBS|Mixed Models Analysis|||Bilateral (baseline) values are the average of the outcome measure data obtained during the 2 bilateral (baseline) conditions: 1) at enrollment before randomization and 2) after randomization. These average values are used to compare the changes associated with the 2 asymmetric conditions.||||0.440
72393026|NCT03462082|144293640|SUPERIORITY|||||||0.051||||||Asymmetric STN-DBS 2 (left STN-DBS reduced) vs. Bilateral STN-DBS|Mixed Models Analysis|||Bilateral (baseline) values are the average of the outcome measure data obtained during the 2 bilateral (baseline) conditions: 1) at enrollment before randomization and 2) after randomization. These average values are used to compare the changes associated with the 2 asymmetric conditions.||||0.051
72393027|NCT03462082|144293641|SUPERIORITY|||||||0.945||||||Asymmetric STN-DBS 1 (right STN-DBS reduced) vs. Bilateral STN-DBS|Mixed Models Analysis|||Bilateral (baseline) values are the average of the outcome measure data obtained during the 2 bilateral (baseline) conditions: 1) at enrollment before randomization and 2) after randomization. These average values are used to compare the changes associated with the 2 asymmetric conditions.||||0.945
72462579|NCT03721978|144448135|OTHER||Location Shift|5.0|||||TWO_SIDED|95.0|1.67|11.67||||||HPV-16 E7: Week 15||11.67|1.67|
72462580|NCT03721978|144448135|OTHER||Location Shift|1.67|||||TWO_SIDED|95.0|0.0|5.0||||||HPV-16 E7: Week 36||5.00|0.00|
72462581|NCT03721978|144448135|OTHER||Location Shift|25.0|||||TWO_SIDED|95.0|15.0|40.0||||||HPV-18 E6: Week 15||40.00|15.00|
72462582|NCT03721978|144448135|OTHER||Location Shift|16.67|||||TWO_SIDED|95.0|10.0|28.33||||||HPV-18 E6: Week 36||28.33|10.00|
72462583|NCT03721978|144448135|OTHER||Location Shift|3.33|||||TWO_SIDED|95.0|1.67|6.67||||||HPV-18 E7: Week 15||6.67|1.67|
72462584|NCT03721978|144448135|OTHER||Location Shift|1.67|||||TWO_SIDED|95.0|0.0|3.33||||||HPV-18 E7: Week 36||3.33|0.00|
72462585|NCT03721978|144448136|OTHER||Location Shift|0.033|||||TWO_SIDED|95.0|-0.004|0.325||||||Parameter: CD8+CD137+Perforin+||0.325|-0.004|
72462586|NCT03721978|144448136|OTHER||Location Shift|0.005|||||TWO_SIDED|95.0|0.0|0.208||||||Parameter: CD8+CD38+Perforin+||0.208|0.000|
72462587|NCT03721978|144448136|OTHER||Location Shift|0.014|||||TWO_SIDED|95.0|-0.055|0.31||||||Parameter: CD8+CD69+Perforin+||0.310|-0.055|
72462588|NCT03721978|144448137|OTHER||Location Shift|0.041|||||TWO_SIDED|95.0|0.004|0.077||||||Parameter: CD8+CD137+Perforin+||0.077|0.004|
72393028|NCT03462082|144293641|SUPERIORITY|||||||0.024||||||Asymmetric STN-DBS 2 (left STN-DBS reduced) vs. Bilateral STN-DBS|Mixed Models Analysis|||Bilateral (baseline) values are the average of the outcome measure data obtained during the 2 bilateral (baseline) conditions: 1) at enrollment before randomization and 2) after randomization. These average values are used to compare the changes associated with the 2 asymmetric conditions.||||0.024
72563716|NCT04947150|144658779|SUPERIORITY|||||||0.872||||||The reported p-value reflects the change across time for the full (Wave 1) sample.|ANOVA|Repeated measures ANOVA||||||.872
72563717|NCT04947150|144658780|SUPERIORITY|||||||0.145||||||The reported p-value reflects the change across time for the full (Wave 2) sample.|ANOVA|Repeated Measures ANOVA||||||.145
72563718|NCT04947150|144658781|SUPERIORITY|||||||0.173||||||The reported p-value reflects the change across time for the full (Wave 2) sample.|ANOVA|Repeated measures ANOVA||||||.173
72563719|NCT04947150|144658782|SUPERIORITY|||||||0.012||||||The reported p-value reflects the change across time for the full (Wave 2) sample.|ANOVA|Repeated measures ANOVA||||||.012
72621132|NCT02732145|144773181|EQUIVALENCE|Question: Is there a difference in the incidence of aching of the vulva among the patients with vulvar discomfort?||||||0.0001|||||||Chi-squared|||Parameter: The difference in the incidence of aching of the vulva among patients with vulvar discomfort.||||0.0001
72393029|NCT03462082|144293642|SUPERIORITY|||||||0.097||||||"Holm-adjusted P-Value: 1.00~\*Gait velocity for Asymmetric STN-DBS 1 (right STN-DBS reduced) vs. Bilateral STN-DBS"|Mixed Models Analysis|||Bilateral (baseline) values are the average of the outcome measure data obtained during the 2 bilateral (baseline) conditions: 1) at enrollment before randomization and 2) after randomization. These average values are used to compare the changes associated with the 2 asymmetric conditions.||||0.097
72393030|NCT03462082|144293642|SUPERIORITY|||||||0.75||||||"Holm-adjusted P-Value: 1.00~\*Gait velocity for Asymmetric STN-DBS 2 (left STN-DBS reduced) vs. Bilateral STN-DBS"|Mixed Models Analysis|||Bilateral (baseline) values are the average of the outcome measure data obtained during the 2 bilateral (baseline) conditions: 1) at enrollment before randomization and 2) after randomization. These average values are used to compare the changes associated with the 2 asymmetric conditions.||||0.750
72393031|NCT03462082|144293643|SUPERIORITY|||||||0.128||||||"Holm-adjusted P-Value: 1.00~\*Step length (mean) for Asymmetric STN-DBS 1 (right STN-DBS reduced) vs. Bilateral STN-DBS"|Mixed Models Analysis|||Bilateral (baseline) values are the average of the outcome measure data obtained during the 2 bilateral (baseline) conditions: 1) at enrollment before randomization and 2) after randomization. These average values are used to compare the changes associated with the 2 asymmetric conditions.||||0.128
72393032|NCT03462082|144293643|SUPERIORITY|||||||0.117||||||"Holm-adjusted P-Value: 1.00~\*Step length (mean) for Asymmetric STN-DBS 2 (left STN-DBS reduced) vs. Bilateral STN-DBS"|Mixed Models Analysis|||Bilateral (baseline) values are the average of the outcome measure data obtained during the 2 bilateral (baseline) conditions: 1) at enrollment before randomization and 2) after randomization. These average values are used to compare the changes associated with the 2 asymmetric conditions.||||0.117
72563720|NCT04947150|144658783|SUPERIORITY|||||||0.008||||||The reported p-value reflects the change across time for the full (Wave 2) sample.|ANOVA|Repeated measures ANOVA||||||.008
72462589|NCT03721978|144448137|OTHER||Location Shift|0.011|||||TWO_SIDED|95.0|0.003|0.028||||||Parameter: CD8+CD38+Perforin+||0.028|0.003|
72462590|NCT03721978|144448137|OTHER||Location Shift|0.034|||||TWO_SIDED|95.0|0.022|0.053||||||Parameter: CD8+CD69+Perforin+||0.053|0.022|
72563721|NCT04947150|144658784|SUPERIORITY||||||<|0.001||||||The reported p-value reflects the change across time for the full (Wave 2) sample.|ANOVA|Repeated measures ANOVA||||||<.001
72563722|NCT04947150|144658785|SUPERIORITY||||||<|0.001||||||The reported p-value reflects the change across time for the full (Wave 2) sample.|ANOVA|Repeated measures ANOVA||||||<.001
72462591|NCT05244226|144448138|SUPERIORITY|||||||0.045|||||||Kruskal-Wallis|Dunn's Kruskal Wallis with Bonferroni correction||||||0.045
72563723|NCT04947150|144658786|SUPERIORITY||||||<|0.001||||||The reported p-value reflects the change across time for the full (Wave 2) sample.|ANOVA|Repeated measures ANOVA||||||<.001
72563724|NCT04947150|144658787|SUPERIORITY|||||||0.382||||||The reported p-value reflects the change across time for the full (Wave 2) sample.|ANOVA|Repeated measures ANOVA||||||.382
72563725|NCT04947150|144658788|SUPERIORITY||||||<|0.001||||||The reported p-value reflects the change across time for the full sample.|ANOVA|Repeated Measures ANOVA||||||<.001
72621133|NCT02732145|144773181|EQUIVALENCE|Question: Is there a difference in the association of different symptoms of the vulva among the patients with vulvar discomfort?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of association of different vulvar symptoms among patients with vulvar discomfort.||||0.0000
72462592|NCT05244226|144448138|SUPERIORITY|||||||0.023|||||||Kruskal-Wallis|Dunn's Kruskal Wallis with Bonferroni correction||||||0.023
72462593|NCT05244226|144448142|SUPERIORITY|||||||0.144|||||||Kruskal-Wallis|||||||0.144
72462594|NCT05244226|144448142|SUPERIORITY|||||||0.322|||||||Kruskal-Wallis|||||||0.322
72462595|NCT05244226|144448143|SUPERIORITY|||||||0.061|||||||Kruskal-Wallis|Dunn's Kruskal Wallis with Bonferroni correction||||||0.061
72462596|NCT05244226|144448143|SUPERIORITY|||||||0.021|||||||Kruskal-Wallis|Dunn's Kruskal Wallis with Bonferroni correction||||||0.021
72462597|NCT02507687|144448144|NON_INFERIORITY|"Statistical non-inferiority of Bimatoprost SR 10 µg to SLT was demonstrated if the upper limit of the 95% confidence interval (CI) for the least squares (LS) mean difference between the Bimatoprost SR 10 µg eyes and SLT eyes was ≤ 1.5 mmHg at Weeks 4, 12, and 24.~Clinical non-inferiority of Bimatoprost SR 10 µg to SLT was considered if the upper limit of the 95% CI was ≤ 1.0 mmHg at 2 out of the 3 visits of Weeks 4, 12, and 24."|LS Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.24||0.0231|TWO_SIDED|95.0|-1.03|-0.08|||Mixed Effect Model Repeated Measurement|The model includes treatment, visit, eye, baseline IOP, treatment-by-visit, visit-by-baseline, and visit-by-eyes interactions as covariates.||||-0.08|-1.03|0.0231
72462598|NCT02507687|144448145|NON_INFERIORITY|"Statistical non-inferiority of Bimatoprost SR 10 µg to SLT was demonstrated if the upper limit of the 95% confidence interval (CI) for the least squares (LS) mean difference between the Bimatoprost SR 10 µg eyes and SLT eyes was ≤ 1.5 mmHg at Weeks 4, 12, and 24.~Clinical non-inferiority of Bimatoprost SR 10 µg to SLT was considered if the upper limit of the 95% CI was ≤ 1.0 mmHg at 2 out of the 3 visits of Weeks 4, 12, and 24."|LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.31||0.1615|TWO_SIDED|95.0|-1.04|0.18|||Mixed Effect Model Repeated Measurement|The model includes treatment, visit, eye, baseline IOP, treatment-by-visit, visit-by-baseline, and visit-by-eyes interactions as covariates.||||0.18|-1.04|0.1615
72393033|NCT03462082|144293643|SUPERIORITY|||||||0.145||||||"Holm-adjusted P-Value: 1.00~\*Step length (right) for Asymmetric STN-DBS 1 (right STN-DBS reduced) vs. Bilateral STN-DBS"|Mixed Models Analysis|||Bilateral (baseline) values are the average of the outcome measure data obtained during the 2 bilateral (baseline) conditions: 1) at enrollment before randomization and 2) after randomization. These average values are used to compare the changes associated with the 2 asymmetric conditions.||||0.145
72393034|NCT03462082|144293643|SUPERIORITY|||||||0.056||||||"Holm-adjusted P-Value: 1.00~\*Step length (right) for Asymmetric STN-DBS 2 (left STN-DBS reduced) vs. Bilateral STN-DBS"|Mixed Models Analysis|||Bilateral (baseline) values are the average of the outcome measure data obtained during the 2 bilateral (baseline) conditions: 1) at enrollment before randomization and 2) after randomization. These average values are used to compare the changes associated with the 2 asymmetric conditions.||||0.056
72393035|NCT03462082|144293643|SUPERIORITY|||||||0.151||||||"Holm-adjusted P-Value: 1.00~\*Step length (left) for Asymmetric STN-DBS 1 (right STN-DBS reduced) vs. Bilateral STN-DBS"|Mixed Models Analysis|||Bilateral (baseline) values are the average of the outcome measure data obtained during the 2 bilateral (baseline) conditions: 1) at enrollment before randomization and 2) after randomization. These average values are used to compare the changes associated with the 2 asymmetric conditions.||||0.151
72501935|NCT01309737|144533715|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.35|STANDARD_ERROR_OF_MEAN|10.98||0.692|TWO_SIDED|95.0|-25.91|17.21|||Mixed Models Analysis|||LS mean difference was derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction, baseline value and repeated measures for visit. Unstructured covariance matrix was used.||17.21|-25.91|0.6920
72501936|NCT01309737|144533719|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Log Rank|||||||<0.0001
72501937|NCT01309737|144533719|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Log Rank|||||||<0.0001
72501938|NCT01309737|144533719|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Log Rank|||||||<0.0001
72563726|NCT04947150|144658789|SUPERIORITY|||||||0.178||||||The reported p-value reflects the change across time for the full sample.|ANOVA|Repeated measures ANOVA||||||.178
72563727|NCT04947150|144658790|SUPERIORITY|||||||0.081||||||The reported p-value reflects the change across time for the full sample.|ANOVA|Repeated measures ANOVA||||||.081
72393036|NCT03462082|144293643|SUPERIORITY|||||||0.129||||||"Holm-adjusted P-Value: 1.00~\*Step length (left) for Asymmetric STN-DBS 2 (left STN-DBS reduced) vs. Bilateral STN-DBS"|Mixed Models Analysis|||Bilateral (baseline) values are the average of the outcome measure data obtained during the 2 bilateral (baseline) conditions: 1) at enrollment before randomization and 2) after randomization. These average values are used to compare the changes associated with the 2 asymmetric conditions.||||0.129
72393037|NCT03462082|144293643|SUPERIORITY|||||||0.698||||||"Holm-adjusted P-Value: 1.00~\*Step length difference for Asymmetric STN-DBS 1 (right STN-DBS reduced) vs. Bilateral STN-DBS"|Mixed Models Analysis|||Bilateral (baseline) values are the average of the outcome measure data obtained during the 2 bilateral (baseline) conditions: 1) at enrollment before randomization and 2) after randomization. These average values are used to compare the changes associated with the 2 asymmetric conditions.||||0.698
72393038|NCT03462082|144293643|SUPERIORITY|||||||0.779||||||"Holm-adjusted P-Value: 1.00~\*Step length difference for Asymmetric STN-DBS 2 (left STN-DBS reduced) vs. Bilateral STN-DBS"|Mixed Models Analysis|||Bilateral (baseline) values are the average of the outcome measure data obtained during the 2 bilateral (baseline) conditions: 1) at enrollment before randomization and 2) after randomization. These average values are used to compare the changes associated with the 2 asymmetric conditions.||||0.779
72501939|NCT01309737|144533720|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Log Rank|||||||<0.0001
72501940|NCT01309737|144533720|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Log Rank|||||||<0.0001
72501941|NCT01309737|144533720|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Log Rank|||||||<0.0001
72501942|NCT01309737|144533721|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Log Rank|||||||<0.0001
72501943|NCT01309737|144533721|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Log Rank|||||||<0.0001
72501944|NCT01309737|144533721|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Log Rank|||||||<0.0001
72501945|NCT01442181|144533760|SUPERIORITY_OR_OTHER|||||||0.03|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Energy and fatigue 3 month vs 6 month in minimally invasive group||||0.03
72501946|NCT01442181|144533760|SUPERIORITY_OR_OTHER|||||||0.01|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Comparison of the fatigue and energy was done in baseline-3 month, and 6 month in each group. Minimally Invasive: baseline vs 3 month||||0.01
72501947|NCT01442181|144533760|SUPERIORITY_OR_OTHER|||||||0.49|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Energy and fatigue in medical therapy group; baseline vs 3 month||||0.49
72501948|NCT01442181|144533760|SUPERIORITY_OR_OTHER|||||||0.06|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Energy and fatigue 3 month vs 6 month||||0.06
72501949|NCT01392183|144533786|SUPERIORITY||Hazard Ratio (HR)|1.36|||||TWO_SIDED|95.0|0.84|2.22|||||Adjusted Hazard Ratio comparing Median PFS of pazopanib (treatment group) to Temsirolimus (control group) as first line of treatment. HR \>1 treatment group performed better, \< 1 the control group performed better =1 groups performed equally.|||2.22|0.84|
72501950|NCT01392183|144533787|SUPERIORITY||Hazard Ratio (HR)|1.16|||||TWO_SIDED|95.0|0.7|1.93|||||Adjusted HR comparing Median OS of pazopanib (treatment group) to Temsirolimus (control group) as first line of treatment. HR \>1 treatment group performed better, \< 1 the control group performed better =1 groups performed equally.|||1.93|0.7|
72501951|NCT03430310|144533788|SUPERIORITY|||||||0.05|||||||ANCOVA|||||||0.05
72501952|NCT01056107|144533843|SUPERIORITY_OR_OTHER|||||||0.0075||95.0|||||Dunnett's test|||||||0.0075
72501953|NCT01056107|144533843|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Dunnett's test|||||||<0.001
72501954|NCT01614457|144533866|SUPERIORITY_OR_OTHER||Least squares (LS) Mean Difference|2.1114||||0.1979|TWO_SIDED|95.0|-1.1305|5.3532|||Mixed Model Repeated Measures|||Analysis was based on mixed effects model for repeated measures (MMRM) with dependent variable absolute change from baseline, with treatment group, visit and treatment by visit interaction as fixed effects, subject as random effect, and with adjustment for the continuous baseline value of age and percent predicted FEV1, using compound symmetry covariance matrix.||5.3532|-1.1305|0.1979
72501955|NCT01614457|144533867|SUPERIORITY_OR_OTHER||LS Mean difference|0.2626||||0.778|TWO_SIDED|95.0|-1.5698|2.095||p-value for the treatment effect is from the slope of BMI (kg/m2) versus time (days).|Linear Mixed model|||Analysis was based on linear mixed model with dependent variable BMI and treatment as a fixed effect, adjustment for baseline percent predicted FEV1, age and visit by treatment interaction was included as covariates and intercept, visit were included as random effects.||2.0950|-1.5698|0.7780
72462599|NCT02507687|144448146|NON_INFERIORITY|"Statistical non-inferiority of Bimatoprost SR 10 µg to SLT was demonstrated if the upper limit of the 95% confidence interval (CI) for the least squares (LS) mean difference between the Bimatoprost SR 10 µg eyes and SLT eyes was ≤ 1.5 mmHg at Weeks 4, 12, and 24.~Clinical non-inferiority of Bimatoprost SR 10 µg to SLT was considered if the upper limit of the 95% CI was ≤ 1.0 mmHg at 2 out of the 3 visits of Weeks 4, 12, and 24."|LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.29||0.1673|TWO_SIDED|95.0|-0.97|0.17|||Mixed Effect Model Repeated Measurement|The model includes treatment, visit, eye, baseline IOP, treatment-by-visit, visit-by-baseline, and visit-by-eyes interactions as covariates.||||0.17|-0.97|0.1673
72462600|NCT00733226|144448150|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.15|STANDARD_ERROR_OF_MEAN|0.52||0.05|TWO_SIDED|95.0|-3.2|-1.1||P value was not need to adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|||The sample size was computed to prove that a 30% decrease of the rate of virus provoked wheezing attacks in the OM-85 group compared with placebo is statistically significant. Approximately 29 analyzable participants in each group were required, with α=0.05 and β=0.10 (ie, with a power of 90%), respectively. The difference of 30% was taken from both pilot study and clinical experience. Sample size estimation was performed by using NCSS and PASS 2000 software.||-1.10|-3.20|0.05
72462601|NCT00733226|144448151|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.08|STANDARD_ERROR_OF_MEAN|0.49|<|0.001|TWO_SIDED|95.0|-3.06|-1.01||P value was not need to adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|||||-1.01|-3.06|<0.001
72462602|NCT00733226|144448152|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-2.11|STANDARD_ERROR_OF_MEAN|0.41|<|0.001|TWO_SIDED|95.0|-2.94|-1.27|||Wilcoxon (Mann-Whitney)|P value was not need to adjusted for multiple comparisons||||-1.27|-2.94|<0.001
72462603|NCT00733226|144448153|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.32|STANDARD_ERROR_OF_MEAN|0.22||0.11|TWO_SIDED|95.0|-0.77|0.11||P value was not need to adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|||||0.11|-0.77|0.110
72462604|NCT00733226|144448154|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.25|STANDARD_ERROR_OF_MEAN|0.14||0.195|TWO_SIDED|95.0|-0.55|0.03||P value was not need to adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|||||0.03|-0.55|0.195
72462605|NCT00733226|144448155|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.22|STANDARD_ERROR_OF_MEAN|0.82||0.452|TWO_SIDED|95.0|-2.87|0.42||P value was not need to adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|||||0.42|-2.87|0.452
72501956|NCT01614457|144533868|SUPERIORITY_OR_OTHER||LS Mean difference|-23.9693|||<|0.0001|TWO_SIDED|95.0|-28.0094|-19.9293|||Mixed Model Repeated Measures|||Analysis was based on MMRM with dependent variable absolute change from baseline, with treatment group, visit and treatment by visit interaction as fixed effects, subject as random effect, and with adjustment for the continuous baseline value of age and percent predicted FEV1, and sweat chloride, using a compound symmetry covariance matrix.||-19.9293|-28.0094|<0.0001
72501957|NCT01614457|144533869|SUPERIORITY_OR_OTHER||LS Mean difference|8.3874||||0.0091|TWO_SIDED|95.0|2.1658|14.609|||Mixed Model Repeated Measures|||Analysis was based on MMRM with dependent variable absolute change from baseline, with treatment group, visit and treatment by visit interaction as fixed effects, subject as random effect, and with adjustment for the continuous baseline value of age and percent predicted FEV1, and CFQ-R respiratory domain score, using compound symmetry covariance matrix.||14.6090|2.1658|0.0091
72462606|NCT03722485|144448157|SUPERIORITY|||||||0.292||||||Confounding variables of image capture techniques, image quality and image analysis noted throughout study conduct prohibits any definitive conclusions to be drawn from this analysis.|Regression, Linear|Test of treatment effect using a generalized linear model with treatment arm, baseline values, and clinical site as factors.||||||0.2920
72462607|NCT03722485|144448158|SUPERIORITY|||||||0.0213||||||Confounding variables of image capture techniques, image quality and image analysis noted throughout study conduct prohibits any definitive conclusions to be drawn from this analysis.|Wilcoxon (Mann-Whitney)|||||||0.0213
72462608|NCT03722485|144448159|SUPERIORITY|||||||0.7422||||||Confounding variables of image capture techniques, image quality and image analysis noted throughout study conduct prohibits any definitive conclusions to be drawn from this analysis.|Wilcoxon (Mann-Whitney)|||||||0.7422
72501958|NCT01614457|144533870|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.928||||0.8556|TWO_SIDED||||||Cox Proportional Hazard Regression|||||||0.8556
72504815|NCT03114969|144540517|SUPERIORITY||Odds Ratio (OR)|1.502||||0.404|TWO_SIDED|95.0|0.578|3.905||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.|||3.905|0.578|0.404
72563728|NCT04947150|144658791|SUPERIORITY|||||||0.343||||||The reported p-value reflects the change across time for the full sample.|ANOVA|Repeated measures ANOVA||||||.343
72563729|NCT04947150|144658792|SUPERIORITY|||||||0.369||||||The reported p-value reflects the change across time for the full sample.|ANOVA|Repeated measures ANOVA||||||.369
72563730|NCT04947150|144658793|SUPERIORITY|||||||0.055||||||The reported p-value reflects the change across time for the full sample.|ANOVA|Repeated measures ANOVA||||||.055
72462609|NCT03722485|144448160|SUPERIORITY|||||||0.6322|||||||Fisher Exact|||||||0.6322
72563731|NCT04947150|144658796|SUPERIORITY|||||||0.001||||||The reported p-value reflects the change across time for the full sample.|ANOVA|Repeated measures ANOVA||||||.001
72563732|NCT04947150|144658797|SUPERIORITY|||||||0.079||||||The reported p-value reflects the change across time for the full sample.|ANOVA|Repeated measures ANOVA||||||.079
72563733|NCT04947150|144658798|SUPERIORITY|||||||0.581||||||The reported p-value reflects the change across time for the full sample.|ANOVA|Repeated measures ANOVA||||||.581
72563734|NCT04947150|144658799|SUPERIORITY||||||<|0.001||||||The reported p-value reflects the change across time for the full sample.|ANOVA|Repeated measures ANOVA||||||<.001
72563735|NCT04947150|144658800|SUPERIORITY||||||<|0.001||||||The reported p-value reflects the change across time for the full sample.|ANOVA|Repeated measures ANOVA||||||<.001
72393039|NCT03462082|144293644|SUPERIORITY|||||||0.874||||||"Holm-adjusted P-Value: 1.00~\*Step length ratio for Asymmetric STN-DBS 1 (right STN-DBS reduced) vs. Bilateral STN-DBS"|Mixed Models Analysis|||Bilateral (baseline) values are the average of the outcome measure data obtained during the 2 bilateral (baseline) conditions: 1) at enrollment before randomization and 2) after randomization. These average values are used to compare the changes associated with the 2 asymmetric conditions.||||0.874
72462610|NCT02762500|144448175|SUPERIORITY||Risk Difference (RD)|-8.1||||0.106|TWO_SIDED|90.0|-18.6|2.5||one-sided p-value|Chi-squared|Statistical test was a one-sided performed at the 5% level of significance. Pearson chi-square test was used to test the null hypothesis.|90% CI obtained based on normal approximation.|The response rate difference is the mean difference in response rates between the treatment and placebo responders. The p-value is based on one-sided Pearson chi-square test.||2.5|-18.6|0.106
72462611|NCT02762500|144448176|SUPERIORITY||Risk Difference (RD)|-8.1||||0.106|TWO_SIDED|90.0|-18.6|2.5||one-sided p-value|Chi-squared|Statistical test was a one-sided performed at the 5% level of significance. Pearson chi-square test was used to test the null hypothesis.|90% CI obtained based on normal approximation.|The response rate difference is the mean difference in response rates between the treatment and placebo responders. The p-value is based on one-sided Pearson chi-square test.||2.5|-18.6|0.106
72462612|NCT02762500|144448177|SUPERIORITY||Risk Difference (RD)|-6.5||||0.235|TWO_SIDED|90.0|-21.1|8.2||one-sided p-value|Chi-squared|Statistical test was a one-sided performed at the 5% level of significance. Pearson chi-square test was used to test the null hypothesis.|90% CI obtained based on normal approximation.|The response rate difference is the mean difference in response rates between the treatment and placebo responders. The p-value is based on one-sided Pearson chi-square test.||8.2|-21.1|0.235
72462613|NCT02762500|144448178|SUPERIORITY||Risk Difference (RD)|-9.7||||0.14|TWO_SIDED|90.0|-24.3|5.0||one-sided p-value|Chi-squared|Statistical test was a one-sided performed at the 5% level of significance. Pearson chi-square test was used to test the null hypothesis.|90% CI obtained based on normal approximation.|The response rate difference is the mean difference in response rates between the treatment and placebo responders. The p-value is based on one-sided Pearson chi-square test.||5.0|-24.3|0.140
72462614|NCT02762500|144448179|SUPERIORITY||Mean Difference (Final Values)|-44.59||||0.032|TWO_SIDED|90.0|-78.66|-10.53|||ANCOVA|The mean change from baseline at Week 8 was analyzed using ANCOVA with a factor for treatment and a covariate for baseline scores.||Subjects included in this analysis were those with a baseline fecal calprotectin value ≥ 250 µg/g.||-10.53|-78.66|0.032
72462615|NCT02762500|144448180|SUPERIORITY||Mean Difference (Final Values)|0.18||||0.708|TWO_SIDED|90.0|-0.6|0.95|||ANCOVA|The mean change from baseline at Week 8 was analyzed using ANCOVA with a factor for treatment and a covariate for baseline scores.||||0.95|-0.60|0.708
72462616|NCT00377312|144448186|NON_INFERIORITY_OR_EQUIVALENCE|The study was designed as a standard dose-escalation study, dose-finding pilot study. The primary outcome measures were safety (hypercalcemia, hypophosphatemia and symptoms/hemodynamic measurements). A modified Fibronacci dose-escalation scheme was employed.|||||<|0.0001|TWO_SIDED|||||The reported p-value corresponds to the increase over time for the PTH 2 pmol group.|Mixed Models Analysis|The level of statistical significance was set at .05 (two-tailed)||||||<.0001
72462617|NCT00377312|144448187|NON_INFERIORITY_OR_EQUIVALENCE|The study was designed as a standard dose-escalation study, dose-finding pilot study. The primary outcome measures were safety (hypercalcemia, hypophosphatemia and symptoms/hemodynamic measurements). A modified Fibronacci dose-escalation scheme was employed.|||||<|0.0001|TWO_SIDED|||||The reported p-value corresponds to the increase over time for the PTH 2 pmol group.|Mixed Models Analysis|The level of statistical significance was set at .05 (two-tailed)||||||<.0001
72462618|NCT00377312|144448188|NON_INFERIORITY_OR_EQUIVALENCE|The study was designed as a standard dose-escalation study, dose-finding pilot study. The primary outcome measures were safety (hypercalcemia, hypophosphatemia and symptoms/hemodynamic measurements). A modified Fibronacci dose-escalation scheme was employed.|||||>|0.05|TWO_SIDED|||||The reported p-value corresponds to change over time for the PTH 2 and PTH 4 pmol groups|Mixed Models Analysis|The level of statistical significance was set at .05 (two-tailed)||||||>0.05
72504710|NCT00077623|144540146|NON_INFERIORITY_OR_EQUIVALENCE|The two RO0503821 dosing schedules were compared separately to epoetin reference using ANCOVA, with Hb at BL and region as the covariates. The test for non-inferiority were based on the lower limit of the two-sided 97.5% confidence interval for the difference between the two groups. When the lower limit was greater than or equal to -0.75 g/dL, the RO0503821 groups were regarded as non-inferior to the epoetin reference group. The confidence level of 97.5% was chosen to adjust for multiplicity .|Mean Difference between groups|-0.022|||<|0.0001|TWO_SIDED|97.5|-0.262|0.217||The p-value for the non-inferiority test can be derived via the t-test.|ANCOVA, CI for difference between groups|||The non-inferiority test for treatment differences in Hb change from baseline, based on ANCOVA analysis with a non-inferiority limit of -0.75 g/dL (Per Protocol Population)||0.217|-0.262|<0.0001
72462619|NCT00377312|144448189|NON_INFERIORITY_OR_EQUIVALENCE|The study was designed as a standard dose-escalation study, dose-finding pilot study. The primary outcome measures were safety (hypercalcemia, hypophosphatemia and symptoms/hemodynamic measurements). A modified Fibronacci dose-escalation scheme was employed.||||||0.01|TWO_SIDED|||||The reported p-value corresponds to change over time for the PTH 2 and PTH 4 pmol groups|Mixed Models Analysis|The level of statistical significance was set at .05 (two-tailed)||||||.01
72462620|NCT00377312|144448190|NON_INFERIORITY_OR_EQUIVALENCE|The study was designed as a standard dose-escalation study, dose-finding pilot study. The primary outcome measures were safety (hypercalcemia, hypophosphatemia and symptoms/hemodynamic measurements). A modified Fibronacci dose-escalation scheme was employed.|||||<|0.05|TWO_SIDED|||||the reported p-values correspond to the decrease compared to baseline in all arms/groups at Days 2-8|Mixed Models Analysis|The level of statistical significance was set at .05 (two-tailed)||||||<.05
72462621|NCT00377312|144448191|NON_INFERIORITY_OR_EQUIVALENCE|The study was designed as a standard dose-escalation study, dose-finding pilot study. The primary outcome measures were safety (hypercalcemia, hypophosphatemia and symptoms/hemodynamic measurements). A modified Fibronacci dose-escalation scheme was employed.||||||0.002|TWO_SIDED|||||the reported p-value corresponds to the increase compared to baseline over time (days 2-8) in the PTH 2 pmol group|Mixed Models Analysis|The level of statistical significance was set at .05 (two-tailed)||||||.002
72563736|NCT04947150|144658801|SUPERIORITY||||||<|0.001||||||The reported p-value reflects the change across time for the full sample.|ANOVA|Repeated measures ANOVA||||||<.001
72462622|NCT00377312|144448193|NON_INFERIORITY_OR_EQUIVALENCE|The study was designed as a standard dose-escalation study, dose-finding pilot study. The primary outcome measures were safety (hypercalcemia, hypophosphatemia and symptoms/hemodynamic measurements). A modified Fibronacci dose-escalation scheme was employed.||||||0.61|TWO_SIDED|||||The reported p-value corresponds to change over time for the PTH 2 and PTH 4 pmol groups|Mixed Models Analysis|The level of statistical significance was set at .05 (two-tailed)||||||.61
72462623|NCT00377312|144448194|NON_INFERIORITY_OR_EQUIVALENCE|The study was designed as a standard dose-escalation study, dose-finding pilot study. The primary outcome measures were safety (hypercalcemia, hypophosphatemia and symptoms/hemodynamic measurements). A modified Fibronacci dose-escalation scheme was employed.|||||<|0.008|TWO_SIDED|||||The reported p-value corresponds to the % increase compared to baseline in all Arms/groups on Days 2-8|Mixed Models Analysis|The level of statistical significance was set at .05 (two-tailed)||||||<.008
72462624|NCT00377312|144448194|NON_INFERIORITY_OR_EQUIVALENCE|The study was designed as a standard dose-escalation study, dose-finding pilot study. The primary outcome measures were safety (hypercalcemia, hypophosphatemia and symptoms/hemodynamic measurements). A modified Fibronacci dose-escalation scheme was employed.|||||>|0.05|TWO_SIDED|||||The reported p-value corresponds the the % change from baseline at follow-up in all Arms/groups|Mixed Models Analysis|The level of statistical significance was set at .05 (two-tailed)||||||>0.05
72462625|NCT00377312|144448195|NON_INFERIORITY_OR_EQUIVALENCE|The study was designed as a standard dose-escalation study, dose-finding pilot study. The primary outcome measures were safety (hypercalcemia, hypophosphatemia and symptoms/hemodynamic measurements). A modified Fibronacci dose-escalation scheme was employed.|||||<|0.0001|TWO_SIDED|||||The reported p-value corresponds to % change (increase) from baseline in all Arms/groups at Days 2-8.|Mixed Models Analysis|The level of statistical significance was set at .05 (two-tailed)||||||<.0001
72462626|NCT00377312|144448195|NON_INFERIORITY_OR_EQUIVALENCE|The study was designed as a standard dose-escalation study, dose-finding pilot study. The primary outcome measures were safety (hypercalcemia, hypophosphatemia and symptoms/hemodynamic measurements). A modified Fibronacci dose-escalation scheme was employed.|||||>|0.05|TWO_SIDED|||||The reported p-value corresponds the the % change from baseline at follow-up in all Arms/groups|Mixed Models Analysis|The level of statistical significance was set at .05 (two-tailed)||||||>0.05
72462627|NCT00377312|144448196|NON_INFERIORITY_OR_EQUIVALENCE|The study was designed as a standard dose-escalation study, dose-finding pilot study. The primary outcome measures were safety (hypercalcemia, hypophosphatemia and symptoms/hemodynamic measurements). A modified Fibronacci dose-escalation scheme was employed.|||||<|0.0001|TWO_SIDED|||||the reported p-value corresponds to % decrease compared to baseline at Days 2-8 in all Arms/groups|Mixed Models Analysis|The level of statistical significance was set at .05 (two-tailed)||||||<.0001
72462628|NCT00377312|144448196|NON_INFERIORITY_OR_EQUIVALENCE|The study was designed as a standard dose-escalation study, dose-finding pilot study. The primary outcome measures were safety (hypercalcemia, hypophosphatemia and symptoms/hemodynamic measurements). A modified Fibronacci dose-escalation scheme was employed.||||||0.01|TWO_SIDED|||||the reported p-value corresponds to % change from baseline at the follow-up visit in all Arms/groups|Mixed Models Analysis|the reported p-value corresponds to % change from baseline at the follow-up visit in all Arms/groups||||||.01
72462629|NCT00377312|144448197|NON_INFERIORITY_OR_EQUIVALENCE|The study was designed as a standard dose-escalation study, dose-finding pilot study. The primary outcome measures were safety (hypercalcemia, hypophosphatemia and symptoms/hemodynamic measurements). A modified Fibronacci dose-escalation scheme was employed.|||||>|0.05|TWO_SIDED|||||the reported p-value corresponds to % change compared to baseline at Days 2-8 in all Arms/groups|Mixed Models Analysis|The level of statistical significance was set at .05 (two-tailed)||||||>.05
72462630|NCT03861429|144448207|SUPERIORITY||Odds Ratio (OR)|3.32||||0.105|TWO_SIDED|95.0|0.78|14.15|||Mixed Models Analysis|||Multilevel logistic regression (generalized estimating equations \[GEE\] with an autoregressive (1) working correlation matrix, logit link function) were fitted to assess the primary hypotheses. The models account for the repeated measures (3 or 4 time points), correlated, data structure per person. An additive model was conducted with contrast coding for each time point, treatment, and follow-up effects.||14.15|.78|.105
72501959|NCT01380899|144533872|SUPERIORITY|IHC analyses revealed intense α-synuclein positive immunostaining in PD patients, showing small nodular deposits from 1 to 2 μm in diameter in the SCL of the epidermis including the epidermal component adjacent to hair follicles, and in cells from PSUs, while control subjects presented null immunoreaction. The α-synuclein inclusions in the two groups of patients were morphologically similar but quantitatively different. These inclusions appeared to be juxtanuclear.|Median Difference (Net)|57.9|STANDARD_DEVIATION|8.85|<|0.01|TWO_SIDED|95.0|44.9|62.6||The presence of alpha-synuclein aggregates expressed as % of cells with inclusions was tested for normality (Shapiro-Wilk test). Then, with the nonparametric Kruskal-Wallis followed by Mann-Whitney U tests (software Statistica 7.0 at 95% confidence).|Kruskal-Wallis|The groups were analyzed with Kruskal-Wallis followed by Mann-Whitney U tests.|The expression of the abnormal protein (alpha-synuclein) must be different between the three groups (PD, AP, and control)|The patients were stratified according to the clinical diagnosis made on the basis of the clinical findings, the MRI, and the progression of the disease. Both the clinical diagnosis and the semiquantitative histological analysis were carried out independently and blind to each other. The presence of aggregates of abnormal a-synuclein, expressed as the percentage of cells with positive inclusions in each experimental group, was tested for normality with the Shapiro-Wilk test.|The patients were stratified according to the clinical diagnosis based on the clinical findings, the MRI, and the progression of the disease. Both the clinical diagnosis and the semiquantitative histological analysis were carried out independently and blind to each other. The presence of aggregates of abnormal α-synuclein, expressed as the percentage of cells with positive inclusions in each experimental group, was tested for normality with the Shapiro-Wilk test. Next, the groups were analyzed with the nonparametric Kruskal-Wallis followed by Mann-Whitney U tests. One independent analysis was performed for each structure, namely the epidermis, PSU, and EG. Assessments were performed using the software Statistica 7.0 (Tulsa, OK) at 95% confidence.|62.6|44.9|< 0.01
72501960|NCT03952130|144533876|NON_INFERIORITY|Noninferiority margin = 0.4% for HbA1c|LS Mean Difference|0.07|||||TWO_SIDED|95.0|-0.11|0.24||||||||0.24|-0.11|
72501961|NCT03952130|144533877|SUPERIORITY||LS Mean Difference|-17.8||||0.003|TWO_SIDED|95.0|-29.4|-6.1|||ANCOVA|||||-6.1|-29.4|0.003
72462631|NCT03861429|144448208|SUPERIORITY||Mean Difference (Final Values)|0.6||||0.04|TWO_SIDED|95.0|0.022|1.178|||Mixed Models Analysis||Calculation of mean differences were derived from mixed model analyses|||1.178|.022|.04
72462632|NCT03861429|144448209|SUPERIORITY||Mean Difference (Final Values)|0.29||||0.001|TWO_SIDED|95.0|0.12|0.46|||Mixed Models Analysis||Calculation of mean differences were derived from mixed model analyses|||.46|.12|.001
72501962|NCT03952130|144533878|SUPERIORITY||LS Mean Difference|-25.5||||0.001|TWO_SIDED|95.0|-41.1|-10.0|||ANCOVA|||||-10.0|-41.1|0.001
72501963|NCT03952130|144533879|OTHER||Relative rate|0.85||||0.834|TWO_SIDED|95.0|0.19|3.77|||Empirical method|||||3.77|0.19|0.834
72501964|NCT03952130|144533880|OTHER||Relative rate|1.0||||0.983|TWO_SIDED|95.0|0.72|1.38|||Negative binomial regression|||\<=30 minutes post meal||1.38|0.72|0.983
72462633|NCT03861429|144448210|SUPERIORITY||Mean Difference (Final Values)|0.35||||0.001|TWO_SIDED|95.0|0.21|0.48|||Mixed Models Analysis||Calculation of mean differences were derived from mixed model analyses|||.48|.21|.001
72462634|NCT03861429|144448211|SUPERIORITY||Mean Difference (Final Values)|0.09||||0.081|TWO_SIDED|95.0|-0.01|0.19|||Mixed Models Analysis|||||.19|-.01|.081
72462635|NCT03861429|144448212|SUPERIORITY||Mean Difference (Final Values)|0.21||||0.033|TWO_SIDED|95.0|0.11|0.3|||Mixed Models Analysis||Calculation of mean differences were derived from mixed model analyses|||.3|.11|.033
72563737|NCT04947150|144658802|SUPERIORITY||||||<|0.001||||||The reported p-value reflects the change across time for the full sample.|ANOVA|Repeated measures ANOVA||||||<.001
72563738|NCT04947150|144658806|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|Paired Sample T-test||||||<.05
72563739|NCT04947150|144658808|SUPERIORITY|||||||0.006|||||||t-test, 2 sided|Paired samples t-test||||||.006
72563740|NCT04947150|144658809|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|Paired samples t-test||||||<.001
72563741|NCT04947150|144658810|SUPERIORITY|||||||0.22|||||||t-test, 2 sided|Paired samples t-test||||||.220
72462636|NCT03327051|144448213|OTHER|An increase in relative abundance of VSL3 bacterial strains at week 4 compared to week 0 (baseline) is considered significant if p\<0.05.||||||0.04|||||||ANOVA|Two-way ANOVA with Bonferroni post-test was used for multi-variable analysis||Within group difference between week 0 and week 4 was analyzed.||||0.04
72462637|NCT03327051|144448213|OTHER|An increase in relative abundance of VSL3 bacterial strains at week 4 compared to week 0 (baseline) is considered significant if p\<0.05.|||||>|0.99|||||||ANOVA|Two-way ANOVA with Bonferroni post-test was used for multi-variable analysis||Within group difference between week 0 and week 4 was analyzed.||||>0.99
72462638|NCT05372913|144448220|NON_INFERIORITY|The non-inferiority (NI) test for the secondary outcome (i.e., PHQ-8 Week 4 EOT score) was assessed using the pre-specified NI margin of 2.0. NI of W-GenZD to CBT-Lite was declared if the upper bound of the one-sided 97.5% confidence interval (CI) was less than 2.|Mean Difference (Net)|-0.67|||||TWO_SIDED|95.0|-2.3|0.96||||||||0.96|-2.30|
72563742|NCT04947150|144658811|SUPERIORITY|||||||0.623|||||||t-test, 2 sided|Paired samples t-test||||||.623
72563743|NCT04947150|144658812|SUPERIORITY|||||||0.577||||||The reported p-value reflects the change across time for the full sample.|ANOVA|Repeated measures ANOVA||||||.577
72563744|NCT04947150|144658813|SUPERIORITY||||||<|0.001||||||The reported p-value reflects the change across time for the full sample.|ANOVA|Repeated measures ANOVA||||||<.001
72563745|NCT04947150|144658814|SUPERIORITY||||||<|0.001||||||The reported p-value reflects the change across time for the full sample.|ANOVA|Repeated measures ANOVA||||||<.001
72563746|NCT04947150|144658815|SUPERIORITY|||||||0.008||||||The reported p-value reflects the change across time for the full sample.|ANOVA|Repeated measures ANOVA||||||.008
72563747|NCT04947150|144658816|SUPERIORITY|||||||0.601||||||The reported p-value reflects the change across time for the full sample.|ANOVA|Repeated Measures ANOVA||||||.601
72563748|NCT04947150|144658817|SUPERIORITY|||||||0.088||||||The reported p-value reflects the change across time for the full sample.|ANOVA|Repeated measures ANOVA||||||.088
72462639|NCT00694564|144448222|NON_INFERIORITY_OR_EQUIVALENCE|No power calculation was calculated as this was a pilot study to determine such parameters.||||||0.004||95.0|||||MANOVA|||||||0.004
72563749|NCT04947150|144658818|SUPERIORITY|||||||0.21||||||The reported p-value reflects the change across time for the full sample.|ANOVA|Repeated measures ANOVA||||||.210
72563750|NCT04947150|144658819|SUPERIORITY|||||||0.06||||||The reported p-value reflects the change across time for the full sample.|ANOVA|Repeated measures ANOVA||||||.060
72563751|NCT04947150|144658820|SUPERIORITY|||||||0.37||||||The reported p-value reflects the change across time for the full sample.|ANOVA|Repeated measures ANOVA||||||.370
72563752|NCT04947150|144658821|SUPERIORITY|||||||0.556||||||The reported p-value reflects the change across time for the full sample.|ANOVA|Repeated Measures ANOVA||||||.556
72563753|NCT04947150|144658822|SUPERIORITY|||||||0.913||||||The reported p-value reflects the change across time for the full sample.|ANOVA|Repeated measures ANOVA||||||.913
72563754|NCT04947150|144658823|SUPERIORITY|||||||0.241||||||The reported p-value reflects the change across time for the full sample.|ANOVA|Repeated Measures ANOVA||||||.241
72563755|NCT02688387|144658894|EQUIVALENCE|Part 3A of the study is designed to test the bioequivalence of a FDC of ambrisentan 10 mg + tadalafil 40 mg (test) relative to reference monotherapies of ambrisentan 10 mg \& tadalafil 40 mg taken concurrently (reference) in healthy participants in both the fed and fasted states.|Ratio|1.0667|||||TWO_SIDED|90.0|0.9657|1.1784|||||X1 Vs R1, ambrisentan|||1.1784|0.9657|
72563756|NCT02688387|144658894|EQUIVALENCE|Part 3A of the study is designed to test the bioequivalence of a FDC of ambrisentan 10 mg + tadalafil 40 mg (test) relative to reference monotherapies of ambrisentan 10 mg \& tadalafil 40 mg taken concurrently (reference) in healthy participants in both the fed and fasted states.|Ratio|1.0353|||||TWO_SIDED|90.0|0.9293|1.1534|||||X2 Vs R2, ambrisentan|||1.1534|0.9293|
72462640|NCT02402465|144448224|SUPERIORITY||Mean Difference (Final Values)|37.0|||>|0.05|TWO_SIDED||||||ANOVA||Mean difference is related to albumin levels in nasal lavages: Unit= ng/ml|||||>0.05
72462641|NCT02402465|144448225|SUPERIORITY||Friedman's Q|14.2||||0.001|TWO_SIDED|||||Bonferroni correction was used to adjust for the fact that each day was tested separately yielding alpha=0.05/3.|Friedman|Non-parametric repeated measures ANOVA||||||0.001
72462642|NCT02402465|144448225|SUPERIORITY||Median Difference (Net)|24.5||||0.02|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.02
72462643|NCT02402465|144448225|SUPERIORITY||Median Difference (Net)|4.5||||0.003|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.003
72462644|NCT02402465|144448225|SUPERIORITY||Median Difference (Net)|48.5||||0.53|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.53
72462645|NCT02402465|144448226|SUPERIORITY||Friedman's Q|5.22||||0.07|TWO_SIDED|||||Alpha=0.05/3 since 3 days are compared|Friedman's Test|||We used Friedman test to compare the distribution of total nasal symptom scores among three treatment groups (Placebo, Fluticasone propionate, Dymista) in each of the three days (day 1, day 2, and day 3).||||0.07
72462646|NCT02402465|144448227|SUPERIORITY||Friedman's Q|5.06||||0.08|TWO_SIDED|||||Bonferroni correction was used to adjust for the fact that each day was tested separately, giving alpha=0.05/3.|Friedman's Test|||||||0.08
72462647|NCT02402465|144448229|SUPERIORITY||Friedman's Q|6.53||||0.04|TWO_SIDED|||||Bonferroni correction was used to adjust for the fact that each day was tested separately, giving alpha=0.05/3.|Friedman's Test|||||||0.04
72393040|NCT03462082|144293644|SUPERIORITY|||||||0.976||||||"Holm-adjusted P-Value: 1.00~\*Step length ratio for Asymmetric STN-DBS 2 (left STN-DBS reduced) vs. Bilateral STN-DBS"|Mixed Models Analysis|||Bilateral (baseline) values are the average of the outcome measure data obtained during the 2 bilateral (baseline) conditions: 1) at enrollment before randomization and 2) after randomization. These average values are used to compare the changes associated with the 2 asymmetric conditions.||||0.976
72393041|NCT03462082|144293644|SUPERIORITY|||||||0.859||||||"Holm-adjusted P-Value: 1.00~\*Step length symmetry for Asymmetric STN-DBS 1 (right STN-DBS reduced) vs. Bilateral STN-DBS"|Mixed Models Analysis|||Bilateral (baseline) values are the average of the outcome measure data obtained during the 2 bilateral (baseline) conditions: 1) at enrollment before randomization and 2) after randomization. These average values are used to compare the changes associated with the 2 asymmetric conditions.||||0.859
72393042|NCT03462082|144293644|SUPERIORITY|||||||0.86||||||"Holm-adjusted P-Value: 1.00~\*Step length symmetry for Asymmetric STN-DBS 2 (left STN-DBS reduced) vs. Bilateral STN-DBS"|Mixed Models Analysis|||Bilateral (baseline) values are the average of the outcome measure data obtained during the 2 bilateral (baseline) conditions: 1) at enrollment before randomization and 2) after randomization. These average values are used to compare the changes associated with the 2 asymmetric conditions.||||0.860
72393043|NCT03462082|144293645|SUPERIORITY|||||||0.04||||||"Holm-adjusted P-Value: 0.480~\*Pitch (minimum) for Asymmetric STN-DBS 1 (right STN-DBS reduced) vs. Bilateral STN-DBS"|Mixed Models Analysis|||Bilateral (baseline) values are the average of the outcome measure data obtained during the 2 bilateral (baseline) conditions: 1) at enrollment before randomization and 2) after randomization. These average values are used to compare the changes associated with the 2 asymmetric conditions.||||0.040
72393044|NCT03462082|144293645|SUPERIORITY|||||||0.883||||||"Holm-adjusted P-Value: 1.00~\*Pitch (minimum) for Asymmetric STN-DBS 2 (left STN-DBS reduced) vs. Bilateral STN-DBS"|Mixed Models Analysis|||Bilateral (baseline) values are the average of the outcome measure data obtained during the 2 bilateral (baseline) conditions: 1) at enrollment before randomization and 2) after randomization. These average values are used to compare the changes associated with the 2 asymmetric conditions.||||0.883
72393045|NCT03462082|144293645|SUPERIORITY|||||||0.071||||||"Holm-adjusted P-Value: 0.781~\*Pitch (maximum) for Asymmetric STN-DBS 1 (right STN-DBS reduced) vs. Bilateral STN-DBS"|Mixed Models Analysis|||Bilateral (baseline) values are the average of the outcome measure data obtained during the 2 bilateral (baseline) conditions: 1) at enrollment before randomization and 2) after randomization. These average values are used to compare the changes associated with the 2 asymmetric conditions.||||0.071
72393046|NCT03462082|144293645|SUPERIORITY|||||||0.327||||||"Holm-adjusted P-Value: 1.00~\*Pitch (maximum) for Asymmetric STN-DBS 2 (left STN-DBS reduced) vs. Bilateral STN-DBS"|Mixed Models Analysis|||Bilateral (baseline) values are the average of the outcome measure data obtained during the 2 bilateral (baseline) conditions: 1) at enrollment before randomization and 2) after randomization. These average values are used to compare the changes associated with the 2 asymmetric conditions.||||0.327
72393047|NCT03462082|144293646|SUPERIORITY|||||||0.487||||||"Holm-adjusted P-Value: 1.00~\*Loudness (minimum) for Asymmetric STN-DBS 1 (right STN-DBS reduced) vs. Bilateral STN-DBS"|Mixed Models Analysis|||Bilateral (baseline) values are the average of the outcome measure data obtained during the 2 bilateral (baseline) conditions: 1) at enrollment before randomization and 2) after randomization. These average values are used to compare the changes associated with the 2 asymmetric conditions.||||0.487
72393048|NCT03462082|144293646|SUPERIORITY|||||||0.861||||||"Holm-adjusted P-Value: 1.00~\*Loudness (minimum) for Asymmetric STN-DBS 2 (left STN-DBS reduced) vs. Bilateral STN-DBS"|Mixed Models Analysis|||Bilateral (baseline) values are the average of the outcome measure data obtained during the 2 bilateral (baseline) conditions: 1) at enrollment before randomization and 2) after randomization. These average values are used to compare the changes associated with the 2 asymmetric conditions.||||0.861
72462648|NCT02402465|144448230|SUPERIORITY||Friedman's Q|0.53|||>|0.05|TWO_SIDED|||||Bonferroni correction was used to adjust for the fact that each day was tested separately, giving alpha=0.05/3.|Friedman's Test|||||||>0.05
72462649|NCT02402465|144448231|SUPERIORITY||Friedman's Q|0.33||||0.85|TWO_SIDED|||||Bonferroni correction was used to adjust for the fact that each day was tested separately, giving alpha=0.05/3.|Friedman's Test|||||||0.85
72563757|NCT02688387|144658894|EQUIVALENCE|Part 3A of the study is designed to test the bioequivalence of a FDC of ambrisentan 10 mg + tadalafil 40 mg (test) relative to reference monotherapies of ambrisentan 10 mg \& tadalafil 40 mg taken concurrently (reference) in healthy participants in both the fed and fasted states.|Ratio|0.9839|||||TWO_SIDED|90.0|0.9288|1.0423|||||X1 Vs R1, tadalafil|||1.0423|0.9288|
72462650|NCT03807700|144448232|SUPERIORITY||Mean Difference (Net)|-0.41|STANDARD_ERROR_OF_MEAN|0.58||0.4769|TWO_SIDED|95.0|-1.56|0.74|||ANCOVA|Analysis was performed using ANCOVA model with study product as a fixed effect and Baseline overall score as a covariate.|Difference is experimental adhesive minus no adhesive.|||0.74|-1.56|0.4769
72462651|NCT02005029|144448241|SUPERIORITY_OR_OTHER|||||||0.036|||||||t-test, 2 sided|||||||0.036
72462652|NCT02005029|144448242|SUPERIORITY_OR_OTHER||Erythromycin:Placebo AUC ratio|1.07|STANDARD_DEVIATION|0.43|||TWO_SIDED|||||||||||||
72621134|NCT02732145|144773181|SUPERIORITY|Question: Is there a difference in the incidence of vulvar itching versus burning in the patients with vulvar dermatosis?||||||0|||||||t-test proportion|||Parameter: The difference in the incidence of vulvar itching versus burning in patients with vulvar dermatosis.||||0.0000
72393049|NCT03462082|144293646|SUPERIORITY|||||||0.411||||||"Holm-adjusted P-Value: 1.00~\*Loudness (maximum) for Asymmetric STN-DBS 1 (right STN-DBS reduced) vs. Bilateral STN-DBS"|Mixed Models Analysis|||Bilateral (baseline) values are the average of the outcome measure data obtained during the 2 bilateral (baseline) conditions: 1) at enrollment before randomization and 2) after randomization. These average values are used to compare the changes associated with the 2 asymmetric conditions.||||0.411
72393050|NCT03462082|144293646|SUPERIORITY|||||||0.997||||||"Holm-adjusted P-Value: 1.00~\*Loudness (maximum) for Asymmetric STN-DBS 2 (left STN-DBS reduced) vs. Bilateral STN-DBS"|Mixed Models Analysis|||Bilateral (baseline) values are the average of the outcome measure data obtained during the 2 bilateral (baseline) conditions: 1) at enrollment before randomization and 2) after randomization. These average values are used to compare the changes associated with the 2 asymmetric conditions.||||0.997
72462653|NCT02005029|144448243|SUPERIORITY_OR_OTHER|||||||0.65|||||||t-test, 2 sided|||||||0.65
72462654|NCT02005029|144448244|SUPERIORITY_OR_OTHER|||||||0.18|||||||t-test, 2 sided|||||||0.18
72462655|NCT02005029|144448245|SUPERIORITY_OR_OTHER|||||||0.4405|||||||t-test, 2 sided|||||||0.4405
72563758|NCT02688387|144658894|EQUIVALENCE|Part 3A of the study is designed to test the bioequivalence of a FDC of ambrisentan 10 mg + tadalafil 40 mg (test) relative to reference monotherapies of ambrisentan 10 mg \& tadalafil 40 mg taken concurrently (reference) in healthy participants in both the fed and fasted states.|Ratio|0.9656|||||TWO_SIDED|90.0|0.9151|1.0188|||||X2 Vs R2, tadalafil|||1.0188|0.9151|
72393051|NCT03462082|144293647|SUPERIORITY|||||||0.388||||||"Holm-adjusted P-Value: 1.00~\*Jitter for Asymmetric STN-DBS 1 (right STN-DBS reduced) vs. Bilateral STN-DBS"|Mixed Models Analysis|||Bilateral (baseline) values are the average of the outcome measure data obtained during the 2 bilateral (baseline) conditions: 1) at enrollment before randomization and 2) after randomization. These average values are used to compare the changes associated with the 2 asymmetric conditions.||||0.388
72393052|NCT03462082|144293647|SUPERIORITY|||||||0.684||||||"Holm-adjusted P-Value: 1.00~\*Jitter for Asymmetric STN-DBS 2 (left STN-DBS reduced) vs. Bilateral STN-DBS"|Mixed Models Analysis|||Bilateral (baseline) values are the average of the outcome measure data obtained during the 2 bilateral (baseline) conditions: 1) at enrollment before randomization and 2) after randomization. These average values are used to compare the changes associated with the 2 asymmetric conditions.||||0.684
72393053|NCT03462082|144293648|SUPERIORITY|||||||0.85||||||"Holm-adjusted P-Value: 1.00~\*Shimmer for Asymmetric STN-DBS 1 (right STN-DBS reduced) vs. Bilateral STN-DBS"|Mixed Models Analysis|||Bilateral (baseline) values are the average of the outcome measure data obtained during the 2 bilateral (baseline) conditions: 1) at enrollment before randomization and 2) after randomization. These average values are used to compare the changes associated with the 2 asymmetric conditions.||||0.850
72393054|NCT03462082|144293648|SUPERIORITY|||||||0.712||||||"Holm-adjusted P-Value: 1.00~\*Shimmer for Asymmetric STN-DBS 2 (left STN-DBS reduced) vs. Bilateral STN-DBS"|Mixed Models Analysis|||Bilateral (baseline) values are the average of the outcome measure data obtained during the 2 bilateral (baseline) conditions: 1) at enrollment before randomization and 2) after randomization. These average values are used to compare the changes associated with the 2 asymmetric conditions.||||0.712
72393055|NCT03462082|144293649|SUPERIORITY|||||||0.501|||||||Mixed Models Analysis|Asymmetric STN-DBS 1 (right STN-DBS reduced) vs. Bilateral STN-DBS||Bilateral (baseline) values are the average of the outcome measure data obtained during the 2 bilateral (baseline) conditions: 1) at enrollment before randomization and 2) after randomization. These average values are used to compare the changes associated with the 2 asymmetric conditions.||||0.501
72393056|NCT03462082|144293649|SUPERIORITY|||||||0.216||||||Asymmetric STN-DBS 2 (left STN-DBS reduced) vs. Bilateral STN-DBS|Mixed Models Analysis|||Bilateral (baseline) values are the average of the outcome measure data obtained during the 2 bilateral (baseline) conditions: 1) at enrollment before randomization and 2) after randomization. These average values are used to compare the changes associated with the 2 asymmetric conditions.||||0.216
72462656|NCT02005029|144448246|SUPERIORITY_OR_OTHER|||||||0.6011|||||||t-test, 2 sided|||||||0.6011
72462657|NCT02005029|144448247|SUPERIORITY_OR_OTHER|||||||0.8923|||||||t-test, 2 sided|||||||0.8923
72462658|NCT02005029|144448248|SUPERIORITY_OR_OTHER|||||||0.832|||||||t-test, 2 sided|||||||0.832
72563759|NCT02688387|144658895|EQUIVALENCE|Part 3A of the study is designed to test the bioequivalence of a FDC of ambrisentan 10 mg + tadalafil 40 mg (test) relative to reference monotherapies of ambrisentan 10 mg \& tadalafil 40 mg taken concurrently (reference) in healthy participants in both the fed and fasted states.|Ratio|1.03|||||TWO_SIDED|90.0|0.9965|1.0646|||||X1 Vs R1, ambrisentan|||1.0646|0.9965|
72621135|NCT02732145|144773181|SUPERIORITY|Question: Is there a difference in the incidence of vulvar itching versus stinging in the patients with vulvar dermatosis?||||||0.0008|||||||t-test proportion|||Parameter: The difference in the incidence of vulvar itching versus stinging in patients with vulvar dermatosis.||||0.0008
72462659|NCT02005029|144448249|SUPERIORITY_OR_OTHER|||||||0.1546|||||||t-test, 2 sided|||||||0.1546
72462660|NCT02005029|144448250|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.75|STANDARD_DEVIATION|5.0||0.0314|TWO_SIDED||||||t-test, 2 sided||"Mean difference in on score versus off score from the MDS UPDRS Part 3 on day of erythromycin minus the mean difference in 'on score versus off score on day of placebo."|||||0.0314
72393057|NCT03462082|144293650|SUPERIORITY||||||>|0.05||||||Non-adjusted P-Values were \>0.05 and Holm-adjusted P-Values were 1.00 for all comparisons, except for the Hopkins Verbal Learning Test-Revised: Delayed Recall. For this test, the non-adjusted P-Value was 0.04 and the Holm-adjusted P-Value was 0.44.|Friedman test|Using ranks for repeated measures (3 conditions)||||||>0.05
72393058|NCT03454997|144293660|SUPERIORITY||Mean Difference (Net)|5.5|||||TWO_SIDED|95.0|3.9|7.1||||||comparison of baseline and 6 months across both groups||7.1|3.9|
72393059|NCT03454997|144293660|SUPERIORITY||Mean Difference (Net)|-0.6|||||TWO_SIDED|95.0|-2.3|1.1||||||between groups differences of change between baseline and 6 months||1.1|-2.3|
72393060|NCT03454997|144293661|SUPERIORITY||Mean Difference (Net)|-0.5|||||TWO_SIDED|95.0|-1.4|0.4||||||leading behavioral weight loss group baseline to 6 months comparison||0.4|-1.4|
72393061|NCT03454997|144293661|SUPERIORITY||Mean Difference (Net)|-0.05|||||TWO_SIDED|95.0|-2.0|1.0||||||leading behavioral weight loss group between group comparison of change||1.0|-2.0|
72393062|NCT03454997|144293661|SUPERIORITY||Mean Difference (Net)|-0.6|||||TWO_SIDED|95.0|-1.4|0.2||||||completing weight ins baseline to 6 month comparison||0.2|-1.4|
72393063|NCT03454997|144293661|SUPERIORITY||Mean Difference (Net)|-1.0|||||TWO_SIDED|95.0|-2.5|0.5||||||completing weigh ins between groups comparison of change||0.5|-2.5|
72393064|NCT03454997|144293661|SUPERIORITY||Mean Difference (Net)|-0.5|||||TWO_SIDED|95.0|-1.2|0.3||||||managing a group session baseline to 6 months comparison||0.3|-1.2|
72393065|NCT03454997|144293661|SUPERIORITY||Mean Difference (Net)|-0.5|||||TWO_SIDED|95.0|-2.0|1.1||||||managing a group session between groups comparison of change||1.1|-2.0|
72393066|NCT03454997|144293662|SUPERIORITY||Mean Difference (Net)|0.5|||||TWO_SIDED|95.0|-2.0|2.9||||||comparison between baseline and 6 months across groups||2.9|-2.0|
72393067|NCT03454997|144293662|SUPERIORITY||Mean Difference (Net)|-4.1|||||TWO_SIDED|95.0|-9.1|0.8||||||between groups comparison of change post training to 6 months||0.8|-9.1|
72393068|NCT03454997|144293663|SUPERIORITY||Mean Difference (Net)|-3.3|||||TWO_SIDED|95.0|-6.9|0.3||||||comparison of baseline to 6 months across both groups||0.3|-6.9|
72393069|NCT03454997|144293663|SUPERIORITY||Mean Difference (Net)|-4.8|||||TWO_SIDED|95.0|-11.4|1.8||||||comparison of between group differences baseline to 6 months||1.8|-11.4|
72393070|NCT03454997|144293664|SUPERIORITY||Mean Difference (Net)|0.3|||||TWO_SIDED|95.0|-0.4|1.1||||||Comparison of Baseline \& 6 Months across both groups||1.1|-0.4|
72462661|NCT02005029|144448251|SUPERIORITY_OR_OTHER||Erythromycin:Placebo Cmax ratio|0.83|STANDARD_DEVIATION|0.24|||TWO_SIDED|||||||||||||
72563760|NCT02688387|144658895|EQUIVALENCE|Part 3A of the study is designed to test the bioequivalence of a FDC of ambrisentan 10 mg + tadalafil 40 mg (test) relative to reference monotherapies of ambrisentan 10 mg \& tadalafil 40 mg taken concurrently (reference) in healthy participants in both the fed and fasted states.|Ratio|1.0141|||||TWO_SIDED|90.0|0.982|1.0473|||||X2 Vs R2, ambrisentan|||1.0473|0.9820|
72563761|NCT02688387|144658895|EQUIVALENCE|Part 3A of the study is designed to test the bioequivalence of a FDC of ambrisentan 10 mg + tadalafil 40 mg (test) relative to reference monotherapies of ambrisentan 10 mg \& tadalafil 40 mg taken concurrently (reference) in healthy participants in both the fed and fasted states.|Ratio|0.9693|||||TWO_SIDED|90.0|0.931|1.0092|||||X1 Vs R1, tadalafil|||1.0092|0.9310|
72563762|NCT02688387|144658895|EQUIVALENCE|Part 3A of the study is designed to test the bioequivalence of a FDC of ambrisentan 10 mg + tadalafil 40 mg (test) relative to reference monotherapies of ambrisentan 10 mg \& tadalafil 40 mg taken concurrently (reference) in healthy participants in both the fed and fasted states.|Ratio|1.0157|||||TWO_SIDED|90.0|0.9553|1.0799|||||X2 Vs R2, tadalafil|||1.0799|0.9553|
72563763|NCT02688387|144658896|EQUIVALENCE|Part 3A of the study is designed to test the bioequivalence of a FDC of ambrisentan 10 mg + tadalafil 40 mg (test) relative to reference monotherapies of ambrisentan 10 mg \& tadalafil 40 mg taken concurrently (reference) in healthy participants in both the fed and fasted states.|Ratio|1.0278|||||TWO_SIDED|90.0|0.9943|1.0623|||||X1 Vs R1, ambrisentan|||1.0623|0.9943|
72393071|NCT03454997|144293664|SUPERIORITY||Mean Difference (Net)|-0.9|||||TWO_SIDED|95.0|-2.0|0.2||||||Between Groups Differences of Change between Baseline \& 6 Months||0.2|-2.0|
72393072|NCT03454997|144293665|SUPERIORITY||Mean Difference (Net)|-0.6|||||TWO_SIDED|95.0|-4.5|3.3||||||comparison of between group differences baseline to 6 months||3.3|-4.5|
72393073|NCT03454997|144293665|SUPERIORITY||Mean Difference (Net)|-1.6|||||TWO_SIDED|95.0|-3.1|0.2||||||comparison of baseline to 6 months across groups||0.2|-3.1|
72393074|NCT03454997|144293666|SUPERIORITY||Mean Difference (Net)|-3.8|||||TWO_SIDED|95.0|-6.1|-1.6||||||comparison of baseline and 6 months across groups||-1.6|-6.1|
72393075|NCT03454997|144293666|SUPERIORITY||Mean Difference (Net)|-6.6|||||TWO_SIDED|95.0|-20.2|6.9||||||between groups differences of change between baseline to 6 months||6.9|-20.2|
72462662|NCT02137239|144448276|SUPERIORITY||Incidence of Change|-1.7|||||TWO_SIDED|95.0|-18.9|16.7||||||Change in Incidence of Treatment A as compared to Treatment B at 6 Months||16.7|-18.9|
72393076|NCT00299975|144293681|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0|||||Chi-squared|Chi-squared test from Crosstabs analysis.||||||<0.05
72393077|NCT00299975|144293682|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Chi-squared|Chi-squared test from Crosstabs analysis.||||||<0.05
72393078|NCT00299975|144293683|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||ANOVA|||||||<0.05
72393079|NCT00299975|144293684|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||ANOVA|||||||<0.05
72393080|NCT00299975|144293685|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Chi-squared|Chi-squared test from Crosstabs analysis was implemented between three treatment groups in each time frame.||||||<0.05
72393081|NCT00299975|144293686|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||ANOVA|||||||<0.05
72393082|NCT00299975|144293687|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||ANOVA|||||||<0.05
72393083|NCT00299975|144293688|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||ANOVA|||||||<0.05
72393084|NCT00299975|144293689|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||ANOVA|||||||<0.05
72393085|NCT00299975|144293690|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||ANOVA|||||||<0.05
72393086|NCT00299975|144293691|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||ANOVA|||||||<0.05
72393087|NCT00299975|144293693|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Paired-Samples T Test|Paired-Samples T Test was implemented between pre-treatment (Wk2) and post-treatment (Wk10) of each treatment group.||||||<0.05
72393088|NCT00299975|144293694|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Paired-Samples T Test|Paired-Samples T Test was implemented between pre-treatment (Wk2) and post-treatment (Wk10) of each treatment group.||||||<0.05
72393089|NCT00299975|144293695|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Paired-Samples T Test|Paired-Samples T Test was implemented between pre-treatment (Wk2) and post-treatment (Wk10) of each treatment group.||||||<0.05
72393090|NCT00299975|144293696|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Paired-Samples T Test|Paired-Samples T Test was implemented between pre-treatment (Wk2) and post-treatment (Wk10) of each treatment group.||||||<0.05
72462663|NCT02137239|144448276|SUPERIORITY||Incidence of Change|-1.0|||||TWO_SIDED|95.0|-19.2|18.9||||||Change in Incidence of Treatment A as compared to Treatment B at 12 Months||18.9|-19.2|
72393091|NCT02397785|144293773|SUPERIORITY|||||||0.8979|||||||t-test, 2 sided|||It was calculated that 52 participants (26 in each arm) was sufficient to detect a 30% reduction in the VAS score (⍺ = 0.05, β = 0.80) from baseline to 12 weeks using paired t-tests, assuming average pain of 80-90 on the VAS and 10% drop-out. Because stratified randomization was performed on the basis of levator ani muscle spasm, there was an imbalance between the size of the sham and active groups, and 58 subjects were ultimately recruited with approval from the Institutional Review Board.||||0.8979
72393092|NCT02397785|144293774|SUPERIORITY|||||||0.9338|||||||Sign test|||||||0.9338
72393093|NCT02397785|144293775|SUPERIORITY|||||||0.1568|||||||Sign test|||||||0.1568
72393094|NCT02397785|144293776|SUPERIORITY|||||||0.3817|||||||Sign test|||||||0.3817
72393095|NCT02397785|144293777|SUPERIORITY|||||||0.286|||||||Sign test|||||||0.2860
72393096|NCT02397785|144293778|SUPERIORITY|||||||0.2884|||||||Sign test|||||||0.2884
72393097|NCT02397785|144293779|SUPERIORITY|||||||0.0855|||||||Sign test|||||||0.0855
72393098|NCT02397785|144293780|SUPERIORITY|||||||0.0287|||||||Sign test|||||||0.0287
72393099|NCT02397785|144293781|SUPERIORITY|||||||0.2887|||||||Sign test|||||||0.2887
72393100|NCT02397785|144293782|SUPERIORITY|||||||0.9954|||||||Sign test|||||||0.9954
72393101|NCT02397785|144293783|SUPERIORITY|||||||0.0574|||||||Sign test|||||||0.0574
72393102|NCT02397785|144293784|SUPERIORITY|||||||0.7827|||||||Sign test|||||||0.7827
72563764|NCT02688387|144658896|EQUIVALENCE|Part 3A of the study is designed to test the bioequivalence of a FDC of ambrisentan 10 mg + tadalafil 40 mg (test) relative to reference monotherapies of ambrisentan 10 mg \& tadalafil 40 mg taken concurrently (reference) in healthy participants in both the fed and fasted states.|Ratio|1.0144|||||TWO_SIDED|90.0|0.9832|1.0466|||||X2 Vs R2, ambrisentan|||1.0466|0.9832|
72393103|NCT02397785|144293785|SUPERIORITY|||||||0.2114|||||||Sign test|||||||0.2114
72393104|NCT02397785|144293786|SUPERIORITY|||||||0.4986|||||||Sign test|||||||0.4986
72393105|NCT02397785|144293787|SUPERIORITY|||||||0.461|||||||Sign test|||||||0.4610
72393106|NCT02397785|144293788|SUPERIORITY|||||||0.2556|||||||Sign test|||||||0.2556
72393107|NCT02397785|144293789|SUPERIORITY|||||||0.0723|||||||t-test, 2 sided|||||||0.0723
72393108|NCT02397785|144293790|SUPERIORITY|||||||0.7456|||||||t-test, 2 sided|||||||0.7456
72393109|NCT02397785|144293791|SUPERIORITY|||||||0.138|||||||t-test, 2 sided|||||||0.1380
72393110|NCT02397785|144293792|SUPERIORITY|||||||0.3155|||||||t-test, 2 sided|||||||0.3155
72393111|NCT01115101|144293794|NON_INFERIORITY_OR_EQUIVALENCE|VAS score at 24h were defined as primary endpoint because of the expectation of the maximal effect at this time. Testing for differences of continuous variables between the study groups at baseline was accomplished by the 2-sample t test for independent samples or the Mann-Whitney U test, as appropriate.|Mean Difference (Net)|0.05|STANDARD_ERROR_OF_MEAN|0.05|<|0.05||95.0|||||Chi-squared|Test selection was based on evaluating the variables for normal distribution employing the Kolmogorov-Smirnov test.||"The sample size of n=120 was computed to detect a difference in VAS score at 24h of 1.2 (30% reduction) at a power of 80%, a two-sided significance level of 0.05.~Because measurements were made several times on the same patients within in two independent groups, GLM Repeated Measurement procedure was applied to test null hypotheses about the effects of both the between-subject factor (study group) and the within-subject factor (time)."||||<0.05
72393112|NCT02454296|144293801|SUPERIORITY_OR_OTHER|||||||0.01|||||||Wilcoxon (Mann-Whitney)|||||||0.01
72393113|NCT02454296|144293802|SUPERIORITY_OR_OTHER|||||||0.05|||||||Wilcoxon (Mann-Whitney)|||||||0.05
72393114|NCT02454296|144293803|SUPERIORITY_OR_OTHER|||||||0.34|||||||Wilcoxon (Mann-Whitney)|||||||0.34
72393115|NCT01370356|144293855|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|8.74|||<|0.0001|TWO_SIDED|95.0|6.09|12.53||Statistical test was 2-sided and a 0.05 level of significance was used. A fixed-sequence procedure was used to adjust for multiplicity. Hierarchy of comparisons: 1) 10-week CA for Weeks 15 - 24, 2) CA for Weeks 21 - 24, 3) CA for Weeks 21 - 52.|Regression, Logistic|||Assuming true CA rate of 6.9% for placebo and 17.2% for varenicline (odds ratio ≥ 2.8), a study randomizing 1404 participants (1:1 ratio) has ≥90% power to detect a difference between the two groups. Analysis was done using a logistic regression model; treatment effect as explanatory variable and investigative center as covariate. The interaction effect was tested using an expanded logistic regression model including treatment-by-center interaction.||12.53|6.09|<0.0001
72393116|NCT01370356|144293856|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.66|||<|0.0001|TWO_SIDED|95.0|4.21|7.61||Statistical test was 2-sided and a 0.05 level of significance was used. A fixed-sequence procedure was used to adjust for multiplicity. Hierarchy of comparisons: 1) 10-week CA for Weeks 15 - 24, 2) CA for Weeks 21 - 24, 3) CA for Weeks 21 - 52.|Regression, Logistic|||Analysis was done using a logistic regression model including treatment effect as the explanatory variable and investigative center as covariate. In addition, the interaction effect was tested using an expanded logistic regression model including the treatment-by-center interaction. However, the inferences reported were based on the logistic regression model including only the main effects of treatment and center, regardless of the significance of the treatment by center interaction.||7.61|4.21|<0.0001
72393117|NCT01370356|144293857|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.02|||<|0.0001|TWO_SIDED|95.0|2.94|5.5||Statistical test was 2-sided and a 0.05 level of significance was used. A fixed-sequence procedure was used to adjust for multiplicity. Hierarchy of comparisons: 1) 10-week CA for Weeks 15 - 24, 2) CA for Weeks 21 - 24, 3) CA for Weeks 21 - 52.|Regression, Logistic|||Analysis was done using a logistic regression model including treatment effect as the explanatory variable and investigative center as covariate. In addition, the interaction effect was tested using an expanded logistic regression model including the treatment-by-center interaction. However, the inferences reported were based on the logistic regression model including only the main effects of treatment and center, regardless of the significance of the treatment by center interaction.||5.50|2.94|<0.0001
72462664|NCT02137239|144448276|SUPERIORITY||Incidence of Change|2.9|||||TWO_SIDED|95.0|-16.1|23.9||||||Change in Incidence of Treatment A as compared to Treatment B at 24 Months||23.9|-16.1|
72462665|NCT01855997|144448310|SUPERIORITY_OR_OTHER|||||||5.59e-06|TWO_SIDED||||||t-test, 2 sided|||rs1876154||||0.00000559
72462666|NCT01855997|144448310|SUPERIORITY_OR_OTHER|||||||7.66e-06|TWO_SIDED||||||t-test, 2 sided|||rs2812338||||0.00000766
72462667|NCT01855997|144448310|SUPERIORITY_OR_OTHER|||||||9.82e-06|TWO_SIDED||||||t-test, 2 sided|||rs10824875||||0.00000982
72462668|NCT01855997|144448310|SUPERIORITY_OR_OTHER|||||||1.27e-06|TWO_SIDED||||||t-test, 2 sided|||rs1831559||||0.00000127
72462669|NCT01855997|144448310|SUPERIORITY_OR_OTHER|||||||3.96e-06|TWO_SIDED||||||t-test, 2 sided|||rs10851257||||0.00000396
72462670|NCT01855997|144448310|SUPERIORITY_OR_OTHER|||||||6.48e-06|TWO_SIDED||||||t-test, 2 sided|||rs6492344||||0.00000648
72462671|NCT01855997|144448310|SUPERIORITY_OR_OTHER|||||||2.21e-06|TWO_SIDED||||||t-test, 2 sided|||rs12584550||||0.00000221
72462672|NCT01855997|144448310|SUPERIORITY_OR_OTHER|||||||9.02e-06|TWO_SIDED||||||t-test, 2 sided|||rs9555773||||0.00000902
72462673|NCT01855997|144448310|SUPERIORITY_OR_OTHER|||||||7.7e-07|TWO_SIDED||||||t-test, 2 sided|||rs7983441||||0.00000077
72462674|NCT01855997|144448310|SUPERIORITY_OR_OTHER|||||||4.8e-07|TWO_SIDED||||||t-test, 2 sided|||rs12446868||||0.00000048
72462675|NCT01855997|144448310|SUPERIORITY_OR_OTHER|||||||3.7e-07|TWO_SIDED||||||t-test, 2 sided|||rs247878||||0.00000037
72501965|NCT03952130|144533880|OTHER||Relative rate|1.61||||0.076|TWO_SIDED|95.0|0.95|2.74|||Negative binomial regression|||\<=1 hour post meal||2.74|0.95|0.076
72501966|NCT03952130|144533880|OTHER||Relative rate|1.19||||0.409|TWO_SIDED|95.0|0.79|1.79|||Negative binomial regression|||\<=2 hours post meal||1.79|0.79|0.409
72501967|NCT03952130|144533880|OTHER||Relative rate|1.22||||0.217|TWO_SIDED|95.0|0.89|1.68|||Negative binomial regression|||\<=4 hours post meal||1.68|0.89|0.217
72501968|NCT03952130|144533880|OTHER||Relative rate|1.09||||0.703|TWO_SIDED|95.0|0.71|1.65|||Negative binomial regression|||\>1 to \<=2 hours post meal||1.65|0.71|0.703
72621136|NCT02732145|144773181|SUPERIORITY|Question: Is there a difference in the incidence of vulvar itching versus soreness in the patients with vulvar dermatosis?||||||0|||||||t-test proportion|||Parameter: The difference in the incidence of vulvar itching versus soreness in patients with vulvar dermatosis.||||0.0000
72462676|NCT01855997|144448311|SUPERIORITY_OR_OTHER|||||||9.87e-06|TWO_SIDED||||||t-test, 2 sided|||rs1876154||||0.00000987
72462677|NCT01855997|144448311|SUPERIORITY_OR_OTHER|||||||6.05e-06|TWO_SIDED||||||t-test, 2 sided|||rs7753766||||0.00000605
72462678|NCT01855997|144448311|SUPERIORITY_OR_OTHER|||||||9.46e-06|TWO_SIDED||||||t-test, 2 sided|||rs604241||||0.00000946
72462679|NCT01855997|144448311|SUPERIORITY_OR_OTHER|||||||7.7e-07|TWO_SIDED||||||t-test, 2 sided|||rs12446868||||0.00000077
72462680|NCT01855997|144448311|SUPERIORITY_OR_OTHER|||||||1.97e-06|TWO_SIDED||||||t-test, 2 sided|||rs247878||||0.00000197
72462681|NCT01855997|144448312|SUPERIORITY_OR_OTHER|||||||6.77e-06|TWO_SIDED||||||t-test, 2 sided|||rs12210761||||0.00000677
72462682|NCT01855997|144448312|SUPERIORITY_OR_OTHER|||||||7.98e-06|TWO_SIDED||||||t-test, 2 sided|||rs1831559||||0.00000798
72462683|NCT01855997|144448312|SUPERIORITY_OR_OTHER|||||||5.12e-06|TWO_SIDED||||||t-test, 2 sided|||rs7983441||||0.00000512
72462684|NCT01855997|144448312|SUPERIORITY_OR_OTHER|||||||3.45e-06|TWO_SIDED||||||t-test, 2 sided|||rs12446868||||0.00000345
72462685|NCT01855997|144448312|SUPERIORITY_OR_OTHER|||||||3.72e-06|TWO_SIDED||||||t-test, 2 sided|||rs247878||||0.00000372
72462686|NCT01855997|144448313|SUPERIORITY_OR_OTHER|||||||4.59e-06|TWO_SIDED||||||t-test, 2 sided|||rs12210761||||0.00000459
72462687|NCT01855997|144448313|SUPERIORITY_OR_OTHER|||||||9.25e-06|TWO_SIDED||||||t-test, 2 sided|||rs1411283||||0.00000925
72462688|NCT01855997|144448313|SUPERIORITY_OR_OTHER|||||||7.72e-06|TWO_SIDED||||||t-test, 2 sided|||rs12446868||||0.00000772
72501969|NCT03952130|144533880|OTHER||Relative rate|1.24||||0.206|TWO_SIDED|95.0|0.89|1.73|||Negative binomial regression|||\>2 to \<=4 hours post meal||1.73|0.89|0.206
72501970|NCT03952130|144533880|OTHER||Relative rate|0.75||||0.082|TWO_SIDED|95.0|0.55|1.04|||Negative binomial regression|||\>4 hours post meal||1.04|0.55|0.082
72501971|NCT03952130|144533881|OTHER||LS Mean Difference|-0.29||||0.309|TWO_SIDED|95.0|-0.86|0.27|||Mixed Models Analysis|||||0.27|-0.86|0.309
72501972|NCT03952130|144533882|OTHER||LS Mean Difference|-15.7|||<|0.001|TWO_SIDED|95.0|-23.8|-7.7|||Mixed Models Analysis|||Morning premeal-fasting||-7.7|-23.8|<.001
72501973|NCT03952130|144533882|OTHER||LS Mean Difference|-14.0||||0.005|TWO_SIDED|95.0|-23.8|-4.2|||Mixed Models Analysis|||Morning 1-hour post meal||-4.2|-23.8|0.005
72462689|NCT01855997|144448314|SUPERIORITY_OR_OTHER|||||||4.7e-06|TWO_SIDED||||||t-test, 2 sided|||rs11163805||||0.00000470
72462690|NCT01855997|144448314|SUPERIORITY_OR_OTHER|||||||6.74e-06|TWO_SIDED||||||t-test, 2 sided|||rs6443144||||0.00000674
72462691|NCT01855997|144448314|SUPERIORITY_OR_OTHER|||||||9.52e-06|TWO_SIDED||||||t-test, 2 sided|||rs11139349||||0.00000952
72462692|NCT01855997|144448314|SUPERIORITY_OR_OTHER|||||||6.08e-06|TWO_SIDED||||||t-test, 2 sided|||rs1831559||||0.00000608
72462693|NCT01855997|144448314|SUPERIORITY_OR_OTHER|||||||4.04e-06|TWO_SIDED||||||t-test, 2 sided|||rs7983441||||0.00000404
72462694|NCT01855997|144448314|SUPERIORITY_OR_OTHER|||||||4.07e-06|TWO_SIDED||||||t-test, 2 sided|||rs11868362||||0.00000407
72462695|NCT01855997|144448315|SUPERIORITY_OR_OTHER|||||||6.66e-06|TWO_SIDED||||||t-test, 2 sided|||rs1384010||||0.00000666
72462696|NCT01855997|144448315|SUPERIORITY_OR_OTHER|||||||8.44e-06|TWO_SIDED||||||t-test, 2 sided|||rs1351518||||0.00000844
72462697|NCT01855997|144448315|SUPERIORITY_OR_OTHER|||||||7.94e-06|TWO_SIDED||||||t-test, 2 sided|||rs1157322||||0.00000794
72462698|NCT01855997|144448315|SUPERIORITY_OR_OTHER|||||||3.1e-06|TWO_SIDED||||||t-test, 2 sided|||rs11868362||||0.00000310
72501974|NCT03952130|144533882|OTHER||LS Mean Difference|-14.9||||0.004|TWO_SIDED|95.0|-25.0|-4.8|||Mixed Models Analysis|||Morning 2-hour post meal||-4.8|-25.0|0.004
72501975|NCT03952130|144533882|OTHER||LS Mean Difference|-2.3||||0.616|TWO_SIDED|95.0|-11.4|6.8|||Mixed Models Analysis|||Midday premeal||6.8|-11.4|0.616
72501976|NCT03952130|144533882|OTHER||LS Mean Difference|-9.1||||0.054|TWO_SIDED|95.0|-18.4|0.1|||Mixed Models Analysis|||Midday 1-hour post meal||0.1|-18.4|0.054
72501977|NCT03952130|144533882|OTHER||LS Mean Difference|-3.3||||0.483|TWO_SIDED|95.0|-12.6|6.0|||Mixed Models Analysis|||Midday 2-hour post meal||6.0|-12.6|0.483
72501978|NCT03952130|144533882|OTHER||LS Mean Difference|10.5||||0.064|TWO_SIDED|95.0|-0.6|21.7|||Mixed Models Analysis|||Evening premeal||21.7|-0.6|0.064
72501979|NCT03952130|144533882|OTHER||LS Mean Difference|-5.6||||0.262|TWO_SIDED|95.0|-15.5|4.2|||Mixed Models Analysis|||Evening 1-hour post meal||4.2|-15.5|0.262
72501980|NCT03952130|144533882|OTHER||LS Mean Difference|-7.8||||0.117|TWO_SIDED|95.0|-17.5|2.0|||Mixed Models Analysis|||Evening 2-hour post meal||2.0|-17.5|0.117
72501981|NCT03952130|144533882|OTHER||LS Mean Difference|-4.4||||0.414|TWO_SIDED|95.0|-15.1|6.2|||Mixed Models Analysis|||Bedtime||6.2|-15.1|0.414
72501982|NCT03952130|144533883|OTHER||LS Mean Difference|0.0||||0.947|TWO_SIDED|95.0|-0.7|0.6|||Mixed Models Analysis|||Basal insulin dose||0.6|-0.7|0.947
72462699|NCT01855997|144448316|SUPERIORITY_OR_OTHER|||||||2.07e-06|TWO_SIDED||||||t-test, 2 sided|||rs11139349||||0.00000207
72462700|NCT01855997|144448316|SUPERIORITY_OR_OTHER|||||||8.99e-06|TWO_SIDED||||||t-test, 2 sided|||rs1157322||||0.00000899
72462701|NCT01855997|144448317|SUPERIORITY_OR_OTHER|||||||5.73e-06|TWO_SIDED||||||t-test, 2 sided|||rs1384010||||0.00000573
72462702|NCT01855997|144448317|SUPERIORITY_OR_OTHER|||||||9.46e-06|TWO_SIDED||||||t-test, 2 sided|||rs1351518||||0.00000946
72462703|NCT01855997|144448317|SUPERIORITY_OR_OTHER|||||||7.31e-06|TWO_SIDED||||||t-test, 2 sided|||rs1157322||||0.00000731
72501983|NCT03952130|144533883|OTHER||LS Mean Difference|0.7||||0.5|TWO_SIDED|95.0|-1.3|2.6|||Mixed Models Analysis|||Bolus insulin dose||2.6|-1.3|0.500
72501984|NCT03952130|144533883|OTHER||LS Mean Difference|0.6||||0.543|TWO_SIDED|95.0|-1.4|2.7|||Mixed Models Analysis|||Total insulin dose||2.7|-1.4|0.543
72501985|NCT03952130|144533884|OTHER||Odds Ratio (OR)|0.81||||0.462|TWO_SIDED|95.0|0.47|1.42|||Regression, Logistic|||For HbA1c \< 7%||1.42|0.47|0.462
72501986|NCT03952130|144533884|OTHER||Odds Ratio (OR)|0.54||||0.089|TWO_SIDED|95.0|0.26|1.1|||Regression, Logistic|||For HbA1c ≤6.5%||1.10|0.26|0.089
72563765|NCT02688387|144658896|EQUIVALENCE|Part 3A of the study is designed to test the bioequivalence of a FDC of ambrisentan 10 mg + tadalafil 40 mg (test) relative to reference monotherapies of ambrisentan 10 mg \& tadalafil 40 mg taken concurrently (reference) in healthy participants in both the fed and fasted states.|Ratio|0.9612|||||TWO_SIDED|90.0|0.9265|0.9972|||||X1 Vs R1, tadalafil|||0.9972|0.9265|
72563766|NCT02688387|144658896|EQUIVALENCE|Part 3A of the study is designed to test the bioequivalence of a FDC of ambrisentan 10 mg + tadalafil 40 mg (test) relative to reference monotherapies of ambrisentan 10 mg \& tadalafil 40 mg taken concurrently (reference) in healthy participants in both the fed and fasted states.|Ratio|1.0122|||||TWO_SIDED|90.0|0.9562|1.0715|||||X2 Vs R2, tadalafil|||1.0715|0.9562|
72462704|NCT01855997|144448317|SUPERIORITY_OR_OTHER|||||||9.45e-06|TWO_SIDED||||||t-test, 2 sided|||rs646097||||0.00000945
72462705|NCT01855997|144448318|SUPERIORITY_OR_OTHER|||||||1.6e-07|TWO_SIDED||||||t-test, 2 sided|||rs17037122||||0.00000016
72462706|NCT01855997|144448319|SUPERIORITY_OR_OTHER|||||||8.8e-07|TWO_SIDED||||||t-test, 2 sided|||rs17037122||||0.00000088
72462707|NCT01855997|144448320|SUPERIORITY_OR_OTHER|||||||8.79e-06|TWO_SIDED||||||t-test, 2 sided|||rs2464266||||0.00000879
72462708|NCT01855997|144448321|SUPERIORITY_OR_OTHER|||||||4.52e-06|TWO_SIDED||||||t-test, 2 sided|||rs9496139||||0.00000452
72462709|NCT01855997|144448321|SUPERIORITY_OR_OTHER|||||||4.97e-06|TWO_SIDED||||||t-test, 2 sided|||rs2014238||||0.00000497
72462710|NCT01855997|144448321|SUPERIORITY_OR_OTHER|||||||4.97e-06|TWO_SIDED||||||t-test, 2 sided|||rs2980231||||0.00000497
72462711|NCT01855997|144448322|SUPERIORITY_OR_OTHER|||||||7.48e-06|TWO_SIDED||||||t-test, 2 sided|||exm2237722||||0.00000748
72462712|NCT01855997|144448322|SUPERIORITY_OR_OTHER|||||||7.3e-07|TWO_SIDED||||||t-test, 2 sided|||rs16924016||||0.00000073
72462713|NCT01855997|144448322|SUPERIORITY_OR_OTHER|||||||2.89e-06|TWO_SIDED||||||t-test, 2 sided|||rs2899723||||0.00000289
72462714|NCT01855997|144448322|SUPERIORITY_OR_OTHER|||||||9.12e-06|TWO_SIDED||||||t-test, 2 sided|||rs8027115||||0.00000912
72462715|NCT01855997|144448322|SUPERIORITY_OR_OTHER|||||||4.94e-06|TWO_SIDED||||||t-test, 2 sided|||exm2267780||||0.00000494
72462716|NCT01855997|144448323|SUPERIORITY_OR_OTHER|||||||6.27e-06|TWO_SIDED||||||t-test, 2 sided|||rs9973954||||0.00000627
72462717|NCT01855997|144448323|SUPERIORITY_OR_OTHER|||||||6.96e-06|TWO_SIDED||||||t-test, 2 sided|||exm2237722||||0.00000696
72462718|NCT01855997|144448323|SUPERIORITY_OR_OTHER|||||||4.26e-06|TWO_SIDED||||||t-test, 2 sided|||rs1040084||||0.00000426
72501987|NCT01713348|144533885|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_DEVIATION|3.3||0.9345|TWO_SIDED|95.0|-1.29|1.19|||t-test, 2 sided|||||1.19|-1.29|0.9345
72501988|NCT01713348|144533885|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.4|STANDARD_DEVIATION|3.5||0.0427|TWO_SIDED|95.0|0.05|2.73|||t-test, 2 sided|||Difference in time in range (70-180 mg/dL, 3.9 to 10.0 mmol/L) intervention arm compared to control arm.||2.73|0.05|0.0427
72501989|NCT01713348|144533886|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.25|STANDARD_DEVIATION|1.18||0.8367|TWO_SIDED|95.0|-2.65|2.16|||ANCOVA|Performed for each type of Diabetes and adjusted for baseline Time in Range.||||2.16|-2.65|0.8367
72501990|NCT01713348|144533886|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.27|STANDARD_DEVIATION|1.05||0.7969|TWO_SIDED|95.0|-1.86|2.4|||ANCOVA|Performed for each type of Diabetes and adjusted for baseline Time in Range.||||2.40|-1.86|0.7969
72462719|NCT01855997|144448323|SUPERIORITY_OR_OTHER|||||||4.35e-06|TWO_SIDED||||||t-test, 2 sided|||rs1913484||||0.00000435
72462720|NCT01855997|144448323|SUPERIORITY_OR_OTHER|||||||2.21e-06|TWO_SIDED||||||t-test, 2 sided|||rs16924016||||0.00000221
72462721|NCT01855997|144448323|SUPERIORITY_OR_OTHER|||||||5.23e-06|TWO_SIDED||||||t-test, 2 sided|||exm1010813||||0.00000523
72462722|NCT01855997|144448323|SUPERIORITY_OR_OTHER|||||||7.57e-06|TWO_SIDED||||||t-test, 2 sided|||rs6576456||||0.00000757
72462723|NCT01855997|144448324|SUPERIORITY_OR_OTHER|||||||1.53e-06|TWO_SIDED||||||t-test, 2 sided|||rs17037122||||0.00000153
72462724|NCT01855997|144448324|SUPERIORITY_OR_OTHER|||||||7.08e-06|TWO_SIDED||||||t-test, 2 sided|||rs10475403||||0.00000708
72462725|NCT01855997|144448324|SUPERIORITY_OR_OTHER|||||||7.27e-06|TWO_SIDED||||||t-test, 2 sided|||rs715243||||0.00000727
72501991|NCT01713348|144533887|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_DEVIATION|0.6||0.0352|TWO_SIDED|95.0|-0.51|-0.02|||t-test, 2 sided|||||-0.02|-0.51|0.0352
72501992|NCT01713348|144533887|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_DEVIATION|0.7||0.0506|TWO_SIDED|95.0|-0.54|0.0|||t-test, 2 sided|||||0.00|-0.54|0.0506
72501993|NCT01713348|144533888|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.0|STANDARD_DEVIATION|8.0||0.058|TWO_SIDED|95.0|-6.4|0.1|||t-test, 2 sided|||||0.1|-6.4|0.0580
72501994|NCT01713348|144533888|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.0|STANDARD_DEVIATION|12.0||0.0002|TWO_SIDED|95.0|-13.6|-4.9|||t-test, 2 sided|||||-4.9|-13.6|0.0002
72501995|NCT01713348|144533889|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_DEVIATION|0.8||0.058|TWO_SIDED|95.0|-0.59|0.01|||t-test, 2 sided|||||0.01|-0.59|0.0580
72501996|NCT01713348|144533889|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8|STANDARD_DEVIATION|1.1||0.0002|TWO_SIDED|95.0|-1.24|-0.45|||t-test, 2 sided|||||-0.45|-1.24|0.0002
72563767|NCT02688387|144658897|EQUIVALENCE|Part 3B of the study is set to establish bioequivalence between the Fixed Dose Combination of an additional two dose strengths (ambrisentan 5 mg + tadalafil 40 mg and ambrisentan 5 mg + tadalafil 20 mg).|Ratio|1.0153|||||TWO_SIDED|90.0|0.9348|1.1027|||||Y1 Vs R3, ambrisentan|||1.1027|0.9348|
72393118|NCT01370356|144293858|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|8.69|||<|0.0001|TWO_SIDED|95.0|6.03|12.51||Statistical test was 2-sided and a 0.05 level of significance was used.|Regression, Logistic|||Statistical analysis presented above is for Week 12. Analysis was done using logistic regression model with treatment effect as the explanatory variable and investigative center as covariate. The interaction effect was tested using an expanded logistic regression model with treatment-by-center interaction. The inferences reported were based on the logistic regression model including only the main effects of treatment and center, regardless of the significance of treatment by center interaction.||12.51|6.03|<0.0001
72563768|NCT02688387|144658897|EQUIVALENCE|Part 3B of the study is set to establish bioequivalence between the Fixed Dose Combination of an additional two dose strengths (ambrisentan 5 mg + tadalafil 40 mg and ambrisentan 5 mg + tadalafil 20 mg).|Ratio|0.9758|||||TWO_SIDED|90.0|0.9044|1.0529|||||Y1 Vs R3, tadalafil|||1.0529|0.9044|
72393119|NCT01370356|144293858|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.58|||<|0.0001|TWO_SIDED|95.0|3.51|5.98||Statistical test was 2-sided and a 0.05 level of significance was used.|Regression, Logistic|||Statistical analysis presented above is for Week 24. Analysis was done using logistic regression model with treatment effect as the explanatory variable and investigative center as covariate. The interaction effect was tested using an expanded logistic regression model with treatment-by-center interaction. The inferences reported were based on the logistic regression model including only the main effects of treatment and center, regardless of the significance of treatment by center interaction.||5.98|3.51|<0.0001
72393120|NCT01370356|144293858|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.66|||<|0.0001|TWO_SIDED|95.0|2.05|3.44||Statistical test was 2-sided and a 0.05 level of significance was used.|Regression, Logistic|||Statistical analysis presented above is for Week 52. Analysis was done using logistic regression model with treatment effect as the explanatory variable and investigative center as covariate. The interaction effect was tested using an expanded logistic regression model with treatment-by-center interaction. The inferences reported were based on the logistic regression model including only the main effects of treatment and center, regardless of the significance of treatment by center interaction.||3.44|2.05|<0.0001
72393121|NCT01370356|144293859|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.67|||<|0.0001|TWO_SIDED|95.0|2.05|3.47||Statistical test was 2-sided and a 0.05 level of significance was used.|Regression, Logistic|||Analysis was done using a logistic regression model including treatment effect as the explanatory variable and investigative center as covariate. In addition, the interaction effect was tested using an expanded logistic regression model including the treatment-by-center interaction. However, the inferences reported were based on the logistic regression model including only the main effects of treatment and center, regardless of the significance of the treatment by center interaction.||3.47|2.05|<0.0001
72393122|NCT00729651|144293876|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.02|||<|0.0001||95.0|0.0|0.08|||Cochran-Mantel-Haenszel|Primary efficacy endpoint was analyzed by a Cochran-Mantel-Haenszel test with baseline vitamin D level as covariate.|Mantel-Haenszel estimator of the common odds ratio was calculated by using Cochran-Mantel-Haenszel test for subjects' proportions with vitamin D deficiency changes at 16 weeks (visit 4) from baseline (visit 1) between treatment groups.|||0.08|0.00|<0.0001
72393123|NCT00729651|144293877|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0091||95.0|||||ANCOVA|Least squares mean is mean of serum PTH percentage changes adjusted serum PTH level at baseline.||||||0.0091
72393124|NCT00729651|144293878|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.02|||<|0.0001||95.0|0.01|0.04|||Cochran-Mantel-Haenszel|It was analyzed by a Cochran-Mantel-Haenszel test with baseline vitamin D level as covariate.|Mantel-Haenszel estimator of the common odds ratio was calculated by using Cochran-Mantel-Haenszel test for subjects' proportions with vitamin D deficiency changes at 16 weeks (visit 4) from baseline (visit 1) between treatment groups.|||0.04|0.01|<0.0001
72393125|NCT01218243|144293917|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.51|STANDARD_ERROR_OF_MEAN|0.93|<|0.01|TWO_SIDED|95.0|2.67|6.36|||ANCOVA|||||6.36|2.67|< 0.01
72563769|NCT02688387|144658898|EQUIVALENCE|Part 3B of the study is set to establish bioequivalence between the Fixed Dose Combination of an additional two dose strengths (ambrisentan 5 mg + tadalafil 40 mg and ambrisentan 5 mg + tadalafil 20 mg).|Ratio|1.039|||||TWO_SIDED|90.0|1.0168|1.0617|||||Y1 Vs R3, ambrisentan|||1.0617|1.0168|
72393126|NCT01218243|144293918|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.34|STANDARD_ERROR_OF_MEAN|6.6|>|0.05|TWO_SIDED|95.0|-9.76|16.44|||Wilcoxon (Mann-Whitney)|||||16.44|-9.76|>0.05
72393127|NCT01218243|144293919|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.184|STANDARD_ERROR_OF_MEAN|0.8|>|0.05|TWO_SIDED|95.0|-1.41|1.78|||ANCOVA|||||1.78|-1.41|> 0.05
72393128|NCT01218243|144293920|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.2|STANDARD_ERROR_OF_MEAN|0.93|<|0.01|TWO_SIDED|95.0|1.36|5.05|||ANCOVA|||||5.05|1.36|< 0.01
72393129|NCT01218243|144293921|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.12|STANDARD_ERROR_OF_MEAN|1.03|<|0.01|TWO_SIDED|95.0|2.07|6.18|||ANCOVA|||||6.18|2.07|<0.01
72393130|NCT02984709|144293925|SUPERIORITY||Estimated Mean Difference|-0.17||||0.593|TWO_SIDED|95.0|-0.81|0.47||The following a priori selected covariates were adjusted in each analysis: age, sex, race/ethnicity, income, baseline depressive symptoms, pump use, and baseline measurement for each outcome.|Multiple linear regression|||||0.47|-0.81|0.593
72393131|NCT02984709|144293926|SUPERIORITY||Estimated Mean Difference|-1.137||||0.581|TWO_SIDED|95.0|-5.27|2.99||The following a priori selected covariates were adjusted in each analysis: age, sex, race/ethnicity, income, baseline depressive symptoms, pump use, and baseline measurement for each outcome.|Multiple linear regression|||||2.99|-5.27|0.581
72393132|NCT02984709|144293927|SUPERIORITY||Estimated Mean Difference|-0.587||||0.206|TWO_SIDED|95.0|-1.52|0.34||The following a priori selected covariates were adjusted in each analysis: age, sex, race/ethnicity, income, baseline depressive symptoms, pump use, and baseline measurement for each outcome.|Multiple linear regression|||||0.34|-1.52|0.206
72393133|NCT02984709|144293928|SUPERIORITY||Estimated Mean Difference|-2.494||||0.511|TWO_SIDED|95.0|-10.11|5.13||The following a priori selected covariates were adjusted in each analysis: age, sex, race/ethnicity, income, baseline depressive symptoms, pump use, and baseline measurement for each outcome.|Multiple linear regression|||Child-reported family conflict||5.13|-10.11|0.511
72462726|NCT01855997|144448325|SUPERIORITY_OR_OTHER|||||||3.97e-06|TWO_SIDED||||||t-test, 2 sided|||rs17037122||||0.00000397
72462727|NCT01855997|144448326|SUPERIORITY_OR_OTHER|||||||6.86e-06|TWO_SIDED||||||t-test, 2 sided|||rs6443144||||0.00000686
72393134|NCT02984709|144293928|SUPERIORITY||Estimated Mean Difference|-3.354||||0.19|TWO_SIDED|95.0|-8.44|1.73||The following a priori selected covariates were adjusted in each analysis: age, sex, race/ethnicity, income, baseline depressive symptoms, pump use, and baseline measurement for each outcome.|Multiple linear regression|||Parent-reported family conflict||1.73|-8.44|0.190
72393135|NCT02984709|144293929|SUPERIORITY||Estimated Mean Difference|0.396||||0.873|TWO_SIDED|95.0|-4.57|5.36||The following a priori selected covariates were adjusted in each analysis: age, sex, race/ethnicity, income, baseline depressive symptoms, pump use, and baseline measurement for each outcome.|Multiple linear regression|||||5.36|-4.57|0.873
72462728|NCT01855997|144448326|SUPERIORITY_OR_OTHER|||||||5.96e-06|TWO_SIDED||||||t-test, 2 sided|||rs2189452||||0.00000596
72501997|NCT01896232|144533890|NON_INFERIORITY_OR_EQUIVALENCE|Etelcalcetide was considered non-inferior to cinacalcet if the upper bound of the 2-sided 95% confidence interval (CI) of the treatment difference (cinacalcet - etelcalcetide) was \< 12%, the prespecified margin for non-inferiority.|Stratified Treatment Difference|-10.48|||||TWO_SIDED|95.0|-17.45|-3.51||||||"The analysis was conducted on the Full Analysis Set (683 participants). Imputation under the non-inferiority null method was applied to participants who did not have PTH data during the EAP.~The Mantel-Haenszel estimator was used to calculate the treatment difference between the proportions (Cinacalcet - Etelcalcetide) stratified by screening PTH level and region."||-3.51|-17.45|
72501998|NCT01896232|144533891|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.65||||0.001|TWO_SIDED|95.0|1.21|2.23|||Cochran-Mantel-Haenszel||The CMH-stratified odds ratio is Etelcalcetide : Cinacalcet.|"Achievement of \> 50% reduction in mean predialysis serum PTH from baseline during the EAP was analyzed using the Cochran-Mantel-Haenszel (CMH) test stratified by screening PTH level and region.~Superiority of etelcalcetide compared with cinacalcet was tested at the 5% significance level (2-sided)."||2.23|1.21|0.001
72501999|NCT01896232|144533892|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.59||||0.004|TWO_SIDED|95.0|1.16|2.17|||Cochran-Mantel-Haenszel||The CMH stratified odds ratio is Etelcalcetide : Cinacalcet.|"Achievement of \> 30% reduction in mean predialysis serum PTH from baseline during the EAP was analyzed using the Cochran-Mantel-Haenszel test stratified by screening PTH level and region.~Superiority of etelcalcetide compared with cinacalcet was tested at the 5% significance level (2-sided)."||2.17|1.16|0.004
72502000|NCT01896232|144533893|SUPERIORITY_OR_OTHER||Treatment Rate Ratio|1.2|STANDARD_ERROR_OF_MEAN|0.15||0.27|TWO_SIDED|95.0|0.89|1.49|||Generalized Linear Mixed Model||The treatment rate ratio is Etelcalcetide : Cinacalcet.|"Analyzed using a generalized linear mixed model with Poisson regression, including screening value of the number of days of nausea and vomiting, treatment, stratification factors (screening PTH level and region), study weeks, and treatment by study weeks as covariates.~Superiority of etelcalcetide compared with cinacalcet was tested at the 5% significance level (2-sided)."||1.49|0.89|0.27
72502001|NCT01896232|144533894|SUPERIORITY_OR_OTHER||Treatment difference|-3.48|STANDARD_ERROR_OF_MEAN|0.65|||TWO_SIDED|95.0|-4.76|-2.21|||||Treatment difference is Etelcalcetide - Cinacalcet.|Analyzed using a repeated measures mixed effects model, including treatment group, randomization stratification factors (screening PTH level and region), study week, and study week by treatment as fixed effects.||-2.21|-4.76|
72563770|NCT02688387|144658898|EQUIVALENCE|Part 3B of the study is set to establish bioequivalence between the Fixed Dose Combination of an additional two dose strengths (ambrisentan 5 mg + tadalafil 40 mg and ambrisentan 5 mg + tadalafil 20 mg).|Ratio|0.9806|||||TWO_SIDED|90.0|0.9106|1.056|||||Y1 Vs R3, tadalafil|||1.0560|0.9106|
72393136|NCT02984709|144293930|SUPERIORITY||Estimated Mean Difference|2.996||||0.603|TWO_SIDED|95.0|-8.57|14.56||The following a priori selected covariates were adjusted in each analysis: age, sex, race/ethnicity, income, baseline depressive symptoms, pump use, and baseline measurement for each outcome.|Multiple linear regression|||||14.56|-8.57|0.603
72393137|NCT02854631|144293955|SUPERIORITY|||||||1|||||||Fisher Exact|P-value from 2-sided Fisher's exact test was used to explore differences between treatment groups in the percentage of participants with an event.||||||1.00
72393138|NCT02854631|144293956|SUPERIORITY|||||||0.061|||||||Fisher Exact|P-value from 2-sided Fisher's exact test was used to explore differences between treatment groups in the percentage of participants with an event.||||||0.061
72393139|NCT02854631|144293957|SUPERIORITY|||||||0.06|||||||Fisher Exact|P-value from 2-sided Fisher's exact test was used to explore differences between treatment groups in the percentage of participants with an event.||||||0.060
72393140|NCT02854631|144293958|SUPERIORITY|||||||0.22||||||P-value from 2-sided Fisher's exact test was used to explore differences between treatment groups in the percentage of participants with an event.|Fisher Exact|||||||0.22
72462729|NCT01855997|144448326|SUPERIORITY_OR_OTHER|||||||4.89e-06|TWO_SIDED||||||t-test, 2 sided|||rs9324018||||0.00000489
72462730|NCT01855997|144448327|SUPERIORITY_OR_OTHER|||||||8.34e-06|TWO_SIDED||||||t-test, 2 sided|||rs2189452||||0.00000834
72462731|NCT01855997|144448327|SUPERIORITY_OR_OTHER|||||||4.87e-06|TWO_SIDED||||||t-test, 2 sided|||rs7968170||||0.00000487
72462732|NCT01855997|144448327|SUPERIORITY_OR_OTHER|||||||9.18e-06|TWO_SIDED||||||t-test, 2 sided|||rs9324018||||0.00000918
72462733|NCT01855997|144448328|SUPERIORITY_OR_OTHER|||||||1.37e-06|TWO_SIDED||||||t-test, 2 sided|||rs9287655||||0.00000137
72462734|NCT01855997|144448328|SUPERIORITY_OR_OTHER|||||||3.39e-06|TWO_SIDED||||||t-test, 2 sided|||rs2803073||||0.00000339
72502002|NCT01896232|144533895|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.15|||||TWO_SIDED|95.0|0.83|1.59|||||The CMH-stratified odds ratio is Etelcalcetide : Cinacalcet.|Analyzed using the Cochran-Mantel-Haenszel method stratified by screening PTH level and region.||1.59|0.83|
72502003|NCT01896232|144533896|SUPERIORITY_OR_OTHER||Treatment Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.08|||TWO_SIDED|95.0|-0.18|0.12|||||Treatment difference is Etelcalcetide - Cinacalcet.|Analyzed using an analysis of covariance (ANCOVA) model adjusted for screening PTH level and region.||0.12|-0.18|
72563771|NCT02688387|144658899|EQUIVALENCE|Part 3B of the study is set to establish bioequivalence between the Fixed Dose Combination of an additional two dose strengths (ambrisentan 5 mg + tadalafil 40 mg and ambrisentan 5 mg + tadalafil 20 mg).|Ratio|1.0365|||||TWO_SIDED|90.0|1.0138|1.0596|||||Y1 Vs R3, ambrisentan|||1.0596|1.0138|
72563772|NCT02688387|144658899|EQUIVALENCE|Part 3B of the study is set to establish bioequivalence between the Fixed Dose Combination of an additional two dose strengths (ambrisentan 5 mg + tadalafil 40 mg and ambrisentan 5 mg + tadalafil 20 mg).|Ratio|0.9821|||||TWO_SIDED|90.0|0.9145|1.0547|||||Y1 Vs R3, tadalafil|||1.0547|0.9145|
72393141|NCT02854631|144293974|SUPERIORITY|||||||0.3|||||||Fisher Exact|Fisher's exact test (2-sided) was used to explore differences between groups in the percentage of participants with response/non-response.||||||0.30
72393142|NCT04774328|144293990|OTHER|Analysis of Variance (ANOVA)|Median Difference (Final Values)|-39.28|STANDARD_ERROR_OF_MEAN|54.818||0.4812|TWO_SIDED|95.0|-152.97|74.4|||ANOVA|||||74.40|-152.97|0.4812
72393143|NCT04774328|144293991|OTHER|ANOVA|Mean Difference (Final Values)|-158.08|STANDARD_ERROR_OF_MEAN|64.232||0.0222|TWO_SIDED|95.0|-291.29|-24.87|||ANOVA|||"Applies to evoked measure of after coughing."||-24.87|-291.29|0.0222
72462735|NCT01855997|144448328|SUPERIORITY_OR_OTHER|||||||9.27e-06|TWO_SIDED||||||t-test, 2 sided|||rs1937590||||0.00000927
72462736|NCT01855997|144448328|SUPERIORITY_OR_OTHER|||||||1.66e-06|TWO_SIDED||||||t-test, 2 sided|||rs2945861||||0.00000166
72462737|NCT01855997|144448328|SUPERIORITY_OR_OTHER|||||||4.55e-06|TWO_SIDED||||||t-test, 2 sided|||rs1997894||||0.00000455
72462738|NCT01855997|144448328|SUPERIORITY_OR_OTHER|||||||5.68e-06|TWO_SIDED||||||t-test, 2 sided|||rs1495471||||0.00000568
72462739|NCT01855997|144448328|SUPERIORITY_OR_OTHER|||||||1.25e-06|TWO_SIDED||||||t-test, 2 sided|||rs9324018||||0.00000125
72462740|NCT01855997|144448328|SUPERIORITY_OR_OTHER|||||||9.82e-06|TWO_SIDED||||||t-test, 2 sided|||rs1152537||||0.00000982
72462741|NCT01855997|144448329|SUPERIORITY_OR_OTHER|||||||8.46e-06|TWO_SIDED||||||t-test, 2 sided|||rs10236906||||0.00000846
72393144|NCT04774328|144293991|OTHER|ANOVA|Mean Difference (Final Values)|-55.04|STANDARD_ERROR_OF_MEAN|43.19||0.2158|TWO_SIDED|95.0|-144.61|34.53|||ANOVA|||"Applies to evoked measure for after sitting up."||34.53|-144.61|0.2158
72462742|NCT01855997|144448329|SUPERIORITY_OR_OTHER|||||||5.62e-06|TWO_SIDED||||||t-test, 2 sided|||rs2945861||||0.00000562
72462743|NCT01855997|144448329|SUPERIORITY_OR_OTHER|||||||4.97e-06|TWO_SIDED||||||t-test, 2 sided|||rs7042473||||0.00000497
72462744|NCT01855997|144448329|SUPERIORITY_OR_OTHER|||||||9.97e-06|TWO_SIDED||||||t-test, 2 sided|||rs2077415||||0.00000997
72462745|NCT01855997|144448329|SUPERIORITY_OR_OTHER|||||||8.64e-06|TWO_SIDED||||||t-test, 2 sided|||rs9324018||||0.00000864
72462746|NCT01855997|144448330|SUPERIORITY_OR_OTHER|||||||3.68e-06|TWO_SIDED||||||t-test, 2 sided|||rs17037122||||0.00000368
72462747|NCT01855997|144448330|SUPERIORITY_OR_OTHER|||||||5.77e-06|TWO_SIDED||||||t-test, 2 sided|||rs715243||||0.00000577
72462748|NCT01855997|144448331|SUPERIORITY_OR_OTHER|||||||9.5e-06|TWO_SIDED||||||t-test, 2 sided|||rs2302503||||0.00000950
72462749|NCT01855997|144448331|SUPERIORITY_OR_OTHER|||||||7.41e-06|TWO_SIDED||||||t-test, 2 sided|||rs6015181||||0.00000741
72462750|NCT01855997|144448332|SUPERIORITY_OR_OTHER|||||||8.05e-06|TWO_SIDED||||||t-test, 2 sided|||rs1550116||||0.00000805
72462751|NCT01855997|144448332|SUPERIORITY_OR_OTHER|||||||7.02e-06|TWO_SIDED||||||t-test, 2 sided|||rs1550115||||0.00000702
72462752|NCT01855997|144448332|SUPERIORITY_OR_OTHER|||||||7.02e-06|TWO_SIDED||||||t-test, 2 sided|||rs2082881||||0.00000702
72462753|NCT01855997|144448332|SUPERIORITY_OR_OTHER|||||||7.43e-06|TWO_SIDED||||||t-test, 2 sided|||exm2265462||||0.00000743
72393145|NCT04774328|144293991|OTHER|ANOVA|Mean Difference (Final Values)|-78.73|STANDARD_ERROR_OF_MEAN|42.532||0.0777|TWO_SIDED|95.0|-166.93|9.48|||ANOVA|||"Applies to evoked measure of after ambulation."||9.48|-166.93|0.0777
72393146|NCT04774328|144293992|OTHER|ANOVA|Mean Difference (Final Values)|-9.375|STANDARD_ERROR_OF_MEAN|12.7245||0.469|TWO_SIDED|95.0|-35.764|17.014|||ANOVA|||Entry applies to OC 0-96 hours.||17.014|-35.764|0.4690
72393147|NCT04774328|144293992|OTHER|ANOVA|Mean Difference (Final Values)|-8.125|STANDARD_ERROR_OF_MEAN|14.5059||0.5811|TWO_SIDED|95.0|-38.208|21.958|||ANOVA|||Applies to OC 0 - Day 8.||21.958|-38.208|0.5811
72393148|NCT02634320|144294031|OTHER|Statistical test is to confirm the change from baseline is statistically different from 0.||||||0.078||||||Change from baseline at last on-treatment visit|t-test, 2 sided|||||||0.078
72393149|NCT02970422|144294039|OTHER|||||||0.91|||||||Chi-squared|Chi-squared value= .57||Relief of breathlessness||||.91
72393150|NCT02970422|144294039|OTHER|||||||0.31|||||||Chi-squared|Chi-squared value= 3.56||Improve your ability to perform activities in and out of your home||||.31
72462754|NCT01855997|144448332|SUPERIORITY_OR_OTHER|||||||7.8e-07|TWO_SIDED||||||t-test, 2 sided|||rs6443144||||0.00000078
72462755|NCT01855997|144448332|SUPERIORITY_OR_OTHER|||||||8.94e-06|TWO_SIDED||||||t-test, 2 sided|||rs1403069||||0.00000894
72462756|NCT01855997|144448332|SUPERIORITY_OR_OTHER|||||||5.71e-06|TWO_SIDED||||||t-test, 2 sided|||rs9691873||||0.00000571
72462757|NCT01855997|144448332|SUPERIORITY_OR_OTHER|||||||7.29e-06|TWO_SIDED||||||t-test, 2 sided|||rs8012912||||0.00000729
72393151|NCT02970422|144294039|OTHER|||||||0.96|||||||Chi-squared|Chi-squared value=.32||Prevent lung flare-ups||||.96
72462758|NCT01855997|144448332|SUPERIORITY_OR_OTHER|||||||8.28e-06|TWO_SIDED||||||t-test, 2 sided|||rs11158827||||0.00000828
72462759|NCT01855997|144448332|SUPERIORITY_OR_OTHER|||||||8.85e-06|TWO_SIDED||||||t-test, 2 sided|||rs11870323||||0.00000885
72462760|NCT01855997|144448332|SUPERIORITY_OR_OTHER|||||||7.17e-06|TWO_SIDED||||||t-test, 2 sided|||rs4821558||||0.00000717
72462761|NCT01855997|144448333|SUPERIORITY_OR_OTHER|||||||6.29e-06|TWO_SIDED||||||t-test, 2 sided|||rs6443144||||0.00000629
72462762|NCT01855997|144448333|SUPERIORITY_OR_OTHER|||||||5.79e-06|TWO_SIDED||||||t-test, 2 sided|||rs1692421||||0.00000579
72462763|NCT01855997|144448333|SUPERIORITY_OR_OTHER|||||||5.53e-06|TWO_SIDED||||||t-test, 2 sided|||rs1692423||||0.00000553
72462764|NCT01855997|144448333|SUPERIORITY_OR_OTHER|||||||9.46e-06|TWO_SIDED||||||t-test, 2 sided|||rs9691873||||0.00000946
72462765|NCT01855997|144448333|SUPERIORITY_OR_OTHER|||||||4.5e-06|TWO_SIDED||||||t-test, 2 sided|||rs7968170||||0.00000450
72462766|NCT01855997|144448334|SUPERIORITY_OR_OTHER|||||||1.18e-06|TWO_SIDED||||||t-test, 2 sided|||rs9287655||||0.00000118
72462767|NCT01855997|144448334|SUPERIORITY_OR_OTHER|||||||5.31e-06|TWO_SIDED||||||t-test, 2 sided|||rs216312||||0.00000531
72462768|NCT01855997|144448335|SUPERIORITY_OR_OTHER|||||||5.93e-06|TWO_SIDED||||||t-test, 2 sided|||rs993147||||0.00000593
72462769|NCT01855997|144448335|SUPERIORITY_OR_OTHER|||||||9.97e-06|TWO_SIDED||||||t-test, 2 sided|||rs10978436||||0.00000997
72462770|NCT01855997|144448335|SUPERIORITY_OR_OTHER|||||||5.81e-06|TWO_SIDED||||||t-test, 2 sided|||rs2370220||||0.00000581
72462771|NCT01855997|144448335|SUPERIORITY_OR_OTHER|||||||8.02e-06|TWO_SIDED||||||t-test, 2 sided|||rs2279519||||0.00000802
72462772|NCT01855997|144448336|SUPERIORITY_OR_OTHER|||||||5.58e-06|TWO_SIDED||||||t-test, 2 sided|||rs12992677||||0.00000558
72462773|NCT01855997|144448337|SUPERIORITY_OR_OTHER|||||||9.9e-06|TWO_SIDED||||||t-test, 2 sided|||rs12992677||||0.00000990
72393152|NCT02970422|144294039|OTHER|||||||0.04|||||||Chi-squared|Chi-squared value= 8.09||Discuss COPD and its progression||||.04
72393153|NCT02970422|144294039|OTHER|||||||0.7|||||||Chi-squared|Chi-squared value: 1.41||Improve your physical well-being||||.70
72462774|NCT01855997|144448338|SUPERIORITY_OR_OTHER|||||||4.8e-07|TWO_SIDED||||||t-test, 2 sided|||rs7549785||||0.00000048
72462775|NCT01855997|144448339|SUPERIORITY_OR_OTHER|||||||4.8e-07|TWO_SIDED||||||t-test, 2 sided|||rs7549785||||0.00000048
72462776|NCT01855997|144448340|SUPERIORITY_OR_OTHER|||||||7.38e-06|TWO_SIDED||||||t-test, 2 sided|||rs10814834||||0.00000738
72462777|NCT01855997|144448340|SUPERIORITY_OR_OTHER|||||||4.51e-06|TWO_SIDED||||||t-test, 2 sided|||rs10491723||||0.00000451
72462778|NCT01855997|144448340|SUPERIORITY_OR_OTHER|||||||8.78e-06|TWO_SIDED||||||t-test, 2 sided|||rs6592052||||0.00000878
72462779|NCT01855997|144448340|SUPERIORITY_OR_OTHER|||||||5.21e-06|TWO_SIDED||||||t-test, 2 sided|||rs16943470||||0.00000521
72462780|NCT01855997|144448341|SUPERIORITY_OR_OTHER|||||||7.2e-06|TWO_SIDED||||||t-test, 2 sided|||rs6592052||||0.00000720
72462781|NCT04864236|144448366|EQUIVALENCE|We compared particle number counts between intervention and control groups using the Wilcoxon test. Analyses were conducted using IBM SPSS V28 and p-values \<0.05 were considered statistically significant.|||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
72462782|NCT04864236|144448367|EQUIVALENCE|Patient characteristics were summarized between groups using mean (SD) and formally compared using the t-test.||||||0.073|||||||t-test, 1 sided|||||||0.073
72462783|NCT04864236|144448368|EQUIVALENCE|Patient characteristics and study variables were summarized between groups using mean (SD) and formally compared using the t-test.||||||0.67|||||||t-test, 1 sided|||||||0.670
72502004|NCT01896232|144533897|SUPERIORITY_OR_OTHER||Treatment Rate Ratio|1.2|STANDARD_ERROR_OF_MEAN|0.22|||TWO_SIDED|95.0|0.86|1.72|||||The treatment rate ratio is Etelcalcetide : Cinacalcet.|This analysis was conducted using a generalized linear mixed model with Poisson regression including screening value of the number of episodes of vomiting, treatment, stratification factors (screening PTH level and region), study weeks, and treatment by study weeks as covariates.||1.72|0.86|
72502005|NCT00686205|144533903|SUPERIORITY_OR_OTHER||Clinical Specificity|99.94||||||95.0|99.88|99.97|||Binomial Exact|Sample size is based on power of 80%, alpha level of 0.05, using the binomial distribution when comparing to a lower bound of specificity at 99.84.||||99.97|99.88|
72462784|NCT04864236|144448369|EQUIVALENCE|Patient characteristics were summarized between groups using mean (SD) and formally compared using the t-test.||||||0.167|||||||t-test, 1 sided|||||||0.167
72462785|NCT04864236|144448370|EQUIVALENCE|Patient characteristics were summarized between groups using mean (SD) and formally compared using the t-test.||||||0.198|||||||t-test, 1 sided|||||||0.198
72462786|NCT04864236|144448371|EQUIVALENCE|Patient characteristics were summarized between groups using mean (SD) and formally compared using the t-test.||||||0.442|||||||t-test, 1 sided|||||||0.442
72462787|NCT04474691|144448376|SUPERIORITY||Mean Difference (Final Values)|21.1||||0.67|TWO_SIDED||||||t-test, 1 sided|df = 7|Traditional treatment condition - visual-acoustic biofeedback treatment condition. Because more accurate productions have lower acoustic values, a positive difference would indicate an advantage for biofeedback.|||||.67
72462788|NCT03418701|144448409|SUPERIORITY||Mean Difference (Final Values)|2.67|||<|0.05|TWO_SIDED|95.0|0.93|4.4|||t-test, 2 sided|||||4.40|0.93|<0.05
72462789|NCT03418701|144448410|SUPERIORITY||Odds Ratio, log|0.47|||<|0.05|TWO_SIDED|95.0|0.22|1.15|||Mixed Models Analysis|A multilevel logistic regression with participants nested within clinic.||||1.15|0.22|<0.05
72462790|NCT02849509|144448411|OTHER||||||<|0.0001||||||p-value of paired t-test compared to baseline|Paired t-test|||Convenience dimension score of PACT-Q2 at the second assessment (Visit 2) were compared with the baseline assessment (Visit 1). There was no (confirmatory) hypothesis testing foreseen in a strict statistical sense. Analyses were descriptive in nature and p-values from statistical models were used for exploratory purposes.||||<0.0001
72462791|NCT02849509|144448411|OTHER|||||||0.0174||||||p-value of paired t-test compared to baseline|Paired t-test|||Satisfaction dimension score of PACT-Q2 at the second assessment (Visit 2) were compared with the baseline assessment (Visit 1). There was no (confirmatory) hypothesis testing foreseen in a strict statistical sense. Analyses were descriptive in nature and p-values from statistical models were used for exploratory purposes.||||0.0174
72462792|NCT02849509|144448412|OTHER||||||<|0.0001||||||p-value of paired t-test compared to baseline|Paired t-test|||Convenience dimension score of PACT-Q2 at the last assessment (Visit 3) were compared with the baseline assessment (Visit 1). There was no (confirmatory) hypothesis testing foreseen in a strict statistical sense. Analyses were descriptive in nature and p-values from statistical models were used for exploratory purposes.||||<0.0001
72462793|NCT02849509|144448412|OTHER|||||||0.0004||||||p-value of paired t-test compared to baseline|Paired t-test|||Satisfaction dimension score of PACT-Q2 at the last assessment (Visit 3) were compared with the baseline assessment (Visit 1). There was no (confirmatory) hypothesis testing foreseen in a strict statistical sense. Analyses were descriptive in nature and p-values from statistical models were used for exploratory purposes.||||0.0004
72462794|NCT02849509|144448413|OTHER|||||||0.0423||||||p-value of paired t-test compared between matched Pradaxa® and VKA patients|Paired t-test|||Convenience dimension score of PACT-Q2 for patients in Cohort B, were compared between matched Pradaxa® and VKA patients at the second assessment. There was no (confirmatory) hypothesis testing foreseen in a strict statistical sense. Analyses were descriptive in nature and p-values from statistical models were used for exploratory purposes.||||0.0423
72502006|NCT00686205|144533904|SUPERIORITY_OR_OTHER||Clinical Sensitivity|100.0||||||95.0|99.76|100.0|||Binomial Exact|||||100.00|99.76|
72502007|NCT00265941|144533905|SUPERIORITY||Hazard Ratio (HR)|1.08||||0.76|TWO_SIDED|95.0|0.88|1.32|||Log Rank||Reference arm = RT + cisplatin|A total of 945 patients were required (900 analyzable) to test for a 25% reduction in the hazard associated with progression-free survival with 84% statistical power using a one-sided log-rank test at the 0.025 significance level (0.0238 after 3 interim analyses).||1.32|0.88|0.76
72393154|NCT02970422|144294039|OTHER|||||||0.01|||||||Chi-squared|Chi-squared value= 10.81||Relief of breathlessness||||.01
72393155|NCT02970422|144294039|OTHER|||||||0.49|||||||Chi-squared|Chi-squared value= 2.41||Improve your ability to perform activities in and out of your home||||.49
72393156|NCT02970422|144294039|OTHER|||||||0.93|||||||Chi-squared|Chi-squared value= .44||Prevent lung flare-ups||||.93
72393157|NCT02970422|144294039|OTHER|||||||0.6|||||||Chi-squared|Chi-squared value= 1.87||Discuss COPD and its progression||||.60
72462795|NCT02849509|144448413|OTHER|||||||0.2226||||||p-value of paired t-test compared between matched Pradaxa® and VKA patients|Paired t-test|||Satisfaction dimension score of PACT-Q2 for patients in Cohort B, were compared between matched Pradaxa® and VKA patients at the second assessment. There was no (confirmatory) hypothesis testing foreseen in a strict statistical sense. Analyses were descriptive in nature and p-values from statistical models were used for exploratory purposes.||||0.2226
72462796|NCT02849509|144448414|OTHER|||||||0.0287||||||p-value of paired t-test compared between matched Pradaxa® and VKA patients|Paired t-test|||Convenience dimension score of PACT-Q2 for patients in Cohort B, were compared between matched Pradaxa® and VKA patients at the second assessment. There was no (confirmatory) hypothesis testing foreseen in a strict statistical sense. Analyses were descriptive in nature and p-values from statistical models were used for exploratory purposes.||||0.0287
72462797|NCT02849509|144448414|OTHER|||||||0.03||||||p-value of paired t-test compared between matched Pradaxa® and VKA patients|Paired t-test|||Satisfaction dimension score of PACT-Q2 for patients in Cohort B, were compared between matched Pradaxa® and VKA patients at the second assessment. There was no (confirmatory) hypothesis testing foreseen in a strict statistical sense. Analyses were descriptive in nature and p-values from statistical models were used for exploratory purposes.||||0.0300
72462798|NCT02849509|144448420|OTHER|||||||0.1234||||||p-value of paired t-test compared between second assessment (Visit 2) and last assessment (Visit 3)|Paired t-test|||Convenience dimension score of PACT-Q2 for patients in Cohort A, were compared between second assessment (Visit 2) and last assessment (Visit 3). There was no (confirmatory) hypothesis testing foreseen in a strict statistical sense. Analyses were descriptive in nature and p-values from statistical models were used for exploratory purposes.||||0.1234
72462799|NCT02849509|144448420|OTHER|||||||0.974||||||p-value of paired t-test compared between second assessment (Visit 2) and last assessment (Visit 3)|Paired t-test|||Satisfaction dimension score of PACT-Q2 for patients in Cohort A, were compared between second assessment (Visit 2) and last assessment (Visit 3). There was no (confirmatory) hypothesis testing foreseen in a strict statistical sense. Analyses were descriptive in nature and p-values from statistical models were used for exploratory purposes.||||0.9740
72462800|NCT01261793|144448422|SUPERIORITY||Odds Ratio (OR)|1.024|||=|0.899|TWO_SIDED|95.0|0.71|1.477||p-values for the comparison of treatment groups have been calculated using logistic regression with factors for treatment, pooled region, and baseline disease status.|Regression, Logistic||Odds ratio: Epratuzumab/Placebo calculated using logistic regression with factors for treatment, pooled region, and baseline disease status.|||1.477|0.710|=0.899
72462801|NCT01261793|144448422|SUPERIORITY||Odds Ratio (OR)|1.07|||=|0.716|TWO_SIDED|95.0|0.743|1.539||p-values for the comparison of treatment groups have been calculated using logistic regression with factors for treatment, pooled region, and baseline disease status.|Regression, Logistic||Odds ratio: Epratuzumab/Placebo calculated using logistic regression with factors for treatment, pooled region, and baseline disease status.|||1.539|0.743|=0.716
72462802|NCT00714688|144448449|SUPERIORITY_OR_OTHER||Difference in Least-Squares Means|-2.7|STANDARD_ERROR_OF_MEAN|1.51||0.136||95.0|-6.04|0.67||The p value was adjusted for multiplicity via Dunnett's test procedure.|ANCOVA|Treatment, gender and country were used as factors and baseline value and age were used as covariates.||Statistical analysis of change from baseline at endpoint.||0.67|-6.04|0.136
72563773|NCT02688387|144658900|EQUIVALENCE|Part 3B of the study is set to establish bioequivalence between the Fixed Dose Combination of an additional two dose strengths (ambrisentan 5 mg + tadalafil 40 mg and ambrisentan 5 mg + tadalafil 20 mg).|Ratio|1.1176|||||TWO_SIDED|90.0|1.0166|1.2287|||||Y2 Vs R4, ambrisentan|||1.2287|1.0166|
72563774|NCT02688387|144658900|EQUIVALENCE|Part 3B of the study is set to establish bioequivalence between the Fixed Dose Combination of an additional two dose strengths (ambrisentan 5 mg + tadalafil 40 mg and ambrisentan 5 mg + tadalafil 20 mg).|Ratio|1.1196|||||TWO_SIDED|90.0|1.0429|1.2019|||||Y2 Vs R4, tadalafil|||1.2019|1.0429|
72462803|NCT00714688|144448449|SUPERIORITY_OR_OTHER||Difference in Least-Squares Means|-4.9|STANDARD_ERROR_OF_MEAN|1.5||0.002||95.0|-8.22|-1.55||The p value was adjusted for multiplicity via Dunnett's test procedure.|ANCOVA|Treatment, gender and country were used as factors and baseline value and age were used as covariates.||Statistical analysis of change from baseline at endpoint.||-1.55|-8.22|0.002
72462804|NCT00714688|144448450|SUPERIORITY_OR_OTHER|||||||0.216||||||Comparison with placebo was performed without multiplicity adjustment.|ANCOVA|The ANCOVA model was performed on ranked data. Treatment, gender \& country were used as factors and baseline value \& age were used as covariates.||Statistical analysis of change from baseline at endpoint.||||0.216
72462805|NCT00714688|144448450|SUPERIORITY_OR_OTHER||||||<|0.001||||||Comparison with placebo was performed without multiplicity adjustment.|ANCOVA|The ANCOVA model has been performed on ranked data. Treatment, gender \& country were used as factors and baseline value \& age were used as covariates.||Statistical analysis of change from baseline at endpoint.||||<0.001
72393158|NCT02970422|144294039|OTHER|||||||0.31|||||||Chi-squared|Chi-squared value= 3.61||Improve your physical well-being||||.31
72462806|NCT00714688|144448451|SUPERIORITY_OR_OTHER|||||||0.052||||||Comparison with placebo was performed without multiplicity adjustment.|ANCOVA|The ANCOVA model has been performed on ranked data. Treatment, gender and country were used as factors and age was used as a covariate.||||||0.052
72462807|NCT00714688|144448451|SUPERIORITY_OR_OTHER|||||||0.002||||||Comparison with placebo was performed without multiplicity adjustment.|ANCOVA|The ANCOVA model has been performed on ranked data. Treatment, gender and country were used as factors and age was used as a covariate.||||||0.002
72563775|NCT02688387|144658901|EQUIVALENCE|Part 3B of the study is set to establish bioequivalence between the Fixed Dose Combination of an additional two dose strengths (ambrisentan 5 mg + tadalafil 40 mg and ambrisentan 5 mg + tadalafil 20 mg).|Ratio|1.0353|||||TWO_SIDED|90.0|1.0009|1.071|||||Y2 Vs R4, ambrisentan|||1.0710|1.0009|
72393159|NCT02970422|144294040|OTHER|||||||0.73|||||||Chi-squared|Chi-squared value: 1.31||To relieve breathlessness in adults living with COPD||||.73
72393160|NCT02970422|144294040|OTHER|||||||0.23|||||||Chi-squared|Chi-squared value= 4.28||To prevent the development of COPD||||.23
72393161|NCT02970422|144294040|OTHER|||||||0.14|||||||Chi-squared|Chi-squared value= 5.51||To prevent lung flare-ups in adults living with COPD||||.14
72393162|NCT02970422|144294040|OTHER|||||||0.52|||||||Chi-squared|Chi-squared value= 2.28||To increase the ability of adults living with COPD to exercise||||.52
72462808|NCT00714688|144448452|SUPERIORITY_OR_OTHER||Difference in Least-Squares Means|-4.2|STANDARD_ERROR_OF_MEAN|1.86||0.023||||||Comparison with placebo was performed without multiplicity adjustment.|ANCOVA|Treatment, gender and country were used as factors and baseline value and age were used as covariates.||Statistical analysis of change from baseline at endpoint.||||0.023
72462809|NCT00714688|144448452|SUPERIORITY_OR_OTHER||Difference in Least-Squares Means|-4.4|STANDARD_ERROR_OF_MEAN|1.83||0.016||||||Comparison with placebo was performed without multiplicity adjustment.|ANCOVA|Treatment, gender and country were used as factors and baseline value and age were used as covariates.||Statistical analysis of change from baseline at endpoint.||||0.016
72462810|NCT03859622|144448454|OTHER|Frequencies and percentages for categorical data.||||||||||||Standard methods are used for the description of data (frequencies and percentages for categorical data)||||Standard methods are used for the description of data (frequencies and percentages for categorical data)|Standard methods are used for the description of data (frequencies and percentages for categorical data)|||
72462811|NCT01524887|144448460|SUPERIORITY_OR_OTHER_LEGACY||Difference in least square means|1.4||||0.243||95.0|-1.0|3.9|||Mixed Models Analysis|||||3.9|-1.0|0.243
72462812|NCT01524887|144448460|SUPERIORITY_OR_OTHER_LEGACY||Difference in least square means|1.0||||0.37||95.0|-1.2|3.3|||Mixed Models Analysis|||||3.3|-1.2|0.370
72502008|NCT00265941|144533906|SUPERIORITY||Hazard Ratio (HR)|0.95||||0.32|TWO_SIDED|95.0|0.74|1.21|||Log Rank|One-sided log-rank significance level of 0.025|Reference level = RT + cisplatin|Arms were compared using a one-sided log-rank test at the 0.025 significance level.||1.21|0.74|0.32
72502009|NCT00265941|144533907|SUPERIORITY||Hazard Ratio (HR)|1.3||||0.97|TWO_SIDED|95.0|0.99|1.7|||Log Rank|One-sided significance level of 0.025|Reference level = RT + cisplatin|||1.70|0.99|0.97
72502010|NCT00265941|144533912|SUPERIORITY|||||||0.74|||||||Kolmogorov-Smirnov|2-sided significance level of 0.05||3 months||||0.74
72502011|NCT00265941|144533912|SUPERIORITY|||||||0.99|||||||Kolmogorov-Smirnov|2-sided significance level of 0.05||12 months||||0.99
72502012|NCT00265941|144533913|SUPERIORITY|||||||0.13|||||||Chi-squared|2-sided significance level of 0.05||Diet 3-month||||0.13
72393163|NCT02970422|144294040|OTHER|||||||0.11|||||||Chi-squared|Chi-squared value= 5.88||To improve the maximal amount of exercise of adults living with COPD in and out of the home||||.11
72462813|NCT01524887|144448461|SUPERIORITY_OR_OTHER_LEGACY||Difference in least square means|-3.9||||0.033||95.0|-7.4|-0.3|||Mixed Models Analysis|||||-0.3|-7.4|0.033
72462814|NCT01524887|144448461|SUPERIORITY_OR_OTHER_LEGACY||Difference in least square means|-0.9||||0.586||95.0|-4.2|2.4|||Mixed Models Analysis|||||2.4|-4.2|0.586
72462815|NCT01524887|144448462|SUPERIORITY_OR_OTHER_LEGACY||Difference in least square means|-0.2||||0.501||95.0|-1.0|0.5|||Mixed Models Analysis|||||0.5|-1.0|0.501
72462816|NCT01524887|144448462|SUPERIORITY_OR_OTHER_LEGACY||Difference in least square means|-0.1||||0.783||95.0|-0.7|0.5|||Mixed Models Analysis|||||0.5|-0.7|0.783
72462817|NCT01524887|144448463|SUPERIORITY_OR_OTHER_LEGACY||Difference in least square means|1.1||||0.571||95.0|-2.6|4.7|||Mixed Models Analysis|||||4.7|-2.6|0.571
72462818|NCT01524887|144448463|SUPERIORITY_OR_OTHER_LEGACY||Difference in least square means|3.7||||0.032||95.0|0.3|7.1|||Mixed Models Analysis|||||7.1|0.3|0.032
72462819|NCT01524887|144448464|SUPERIORITY_OR_OTHER_LEGACY||Difference in least square means|-0.00026||||0.593||95.0|-0.00126|0.00073|||ANCOVA|||||0.00073|-0.00126|0.593
72502013|NCT00265941|144533913|SUPERIORITY|||||||0.87|||||||Chi-squared|2-sided significance level 0.05||Diet 12-month||||0.87
72502014|NCT00265941|144533913|SUPERIORITY|||||||0.39|||||||Chi-squared|2-sided significance level of 0.05||Eating 3-month||||0.39
72502015|NCT00265941|144533913|SUPERIORITY|||||||0.16|||||||Chi-squared|2-sided significance level of 0.05||Eating 12-month||||0.16
72502016|NCT00265941|144533913|SUPERIORITY|||||||0.81|||||||Chi-squared|2-sided significance level of 0.05||Speech 3-month||||0.81
72502017|NCT00265941|144533913|SUPERIORITY|||||||0.67|||||||Chi-squared|2-sided significance level of 0.05||Speech 12-month||||0.67
72502018|NCT00265941|144533914|SUPERIORITY|||||||0.016|||||||t-test, 2 sided|2-sided significance level of 0.05||||||0.016
72502019|NCT00265941|144533915|SUPERIORITY||Hazard Ratio (HR)|1.09||||0.6|TWO_SIDED|95.0|0.79|1.51|||Log Rank|2-sided significance level = 0.05|Reference level = low EGFR|Progression-free survival is compared between favorable risk and unfavorable risk groups.||1.51|0.79|0.60
72502020|NCT00265941|144533915|SUPERIORITY||Hazard Ratio (HR)|1.19||||0.37|TWO_SIDED|95.0|0.81|1.76|||Log Rank|2-sided significance level = 0.05|Reference level = low EGFR|Overall survival is compared between favorable risk and unfavorable risk groups.||1.76|0.81|0.37
72502021|NCT00265941|144533915|SUPERIORITY||Hazard Ratio (HR)|0.93||||0.76|TWO_SIDED|95.0|0.6|1.46|||Log Rank|2-sided significance level = 0.05|Reference level = low EGFR|Local-regional failure||1.46|0.60|0.76
72502022|NCT00265941|144533916|SUPERIORITY||Hazard Ratio (HR)|0.3||||0.01|TWO_SIDED|95.0|0.12|0.75|||Log Rank|2-sided significance level = 0.05|Reference level = low|Progression-free survival is compared between low and high SUVmax groups.||0.75|0.12|0.01
72502023|NCT00265941|144533916|SUPERIORITY||Hazard Ratio (HR)|0.38||||0.1|TWO_SIDED|95.0|0.12|1.2|||Log Rank|2-sided significance level = 0.05|Reference level = low|Overall survival (OS) is compared between low and high SUVmax groups.||1.20|0.12|0.10
72502024|NCT00265941|144533916|SUPERIORITY||Hazard Ratio (HR)|0.31||||0.04|TWO_SIDED|95.0|0.1|0.97|||Log Rank|2-sided significance level = 0.05|Reference level = low|Loco-regional control (LRC) is compared between low and high SUVmax groups.||0.97|0.10|0.04
72563776|NCT02688387|144658901|EQUIVALENCE|Part 3B of the study is set to establish bioequivalence between the Fixed Dose Combination of an additional two dose strengths (ambrisentan 5 mg + tadalafil 40 mg and ambrisentan 5 mg + tadalafil 20 mg).|Ratio|1.0362|||||TWO_SIDED|90.0|0.991|1.0834|||||Y2 Vs R4, tadalafil|||1.0834|0.9910|
72393164|NCT02970422|144294040|OTHER|||||||0.14|||||||Chi-squared|Chi-squared value= 5.57||To relieve breathlessness in adults living with COPD||||.14
72393165|NCT02970422|144294040|OTHER|||||||0.73|||||||Chi-squared|Chi-squared value= 1.29||To prevent the development of COPD||||.73
72393166|NCT02970422|144294040|OTHER|||||||0.2|||||||Chi-squared|Chi-squared value= 4.64||To prevent lung flare-ups in adults living with COPD||||.20
72393167|NCT02970422|144294040|OTHER|||||||0.17|||||||Chi-squared|Chi-squared value= 5.02||To increase the ability of adults living with COPD to exercise||||.17
72393168|NCT02970422|144294040|OTHER|||||||0.02|||||||Chi-squared|Chi-square value= 9.97||To improve the maximal amount of exercise of adults living with COPD in and out of the home||||.02
72393169|NCT02970422|144294041|OTHER|||||||0.05|||||||Chi-squared|Chi squared value= 17.20||Activity 1: Walking from one place to another outside of your home on a flat surface||||.05
72393170|NCT02970422|144294041|OTHER|||||||0.87|||||||Chi-squared|Chi-squared value= 4.56||Activity 2: Moving from one place to another using motorized transportation||||.87
72393171|NCT02970422|144294041|OTHER|||||||0.65|||||||Chi-squared|Chi-squared value= 6.85||Activity 3: Climbing two or more flights of stairs||||.65
72393172|NCT02970422|144294041|OTHER|||||||0.35|||||||Chi-squared|Chi-squared value= 10.00||Activity 4: Walking up a hill||||.35
72393173|NCT02970422|144294041|OTHER|||||||0.03|||||||Chi-squared|Chi-squared value= 18.75||Activity 5: Participating in regular exercise requiring physical effort, to maintain or improve health or fitness||||.03
72393174|NCT02970422|144294041|OTHER|||||||0|||||||Chi-squared|Chi-squared value= 35.52||Activity 1: Walking from one place to another outside of your home on a flat surface||||.00
72393175|NCT02970422|144294041|OTHER|||||||0.33|||||||Chi-squared|Chi-squared value= 10.23||Activity 2: Moving from one place to another using motorized transportation||||.33
72462820|NCT01524887|144448464|SUPERIORITY_OR_OTHER_LEGACY||Difference in least square means|0.00003||||0.94||95.0|-0.0008|0.00086|||ANCOVA|||||0.00086|-0.00080|0.940
72393176|NCT02970422|144294041|OTHER|||||||0|||||||Chi-squared|Chi-squared value= 23.94||Activity 3: Climbing two or more flights of stairs||||.00
72393177|NCT02970422|144294041|OTHER|||||||0.01|||||||Chi-squared|Chi-squared value= 22.80||Activity 4: Walking up a hill||||.01
72393178|NCT02970422|144294041|OTHER|||||||0.02|||||||Chi-squared|Chi-squared value= 20.43||Activity 5: Participating in regular exercise requiring physical effort, to maintain or improve health or fitness||||.02
72393179|NCT02970422|144294042|OTHER|||||||0|||||||Kruskal-Wallis|Non-parametric led to equal variance (levene's test) which couldn't be assumed, independent samples were taken (Kruskal-Wallis)|||F(3,144)=137.82|||.00
72393180|NCT02970422|144294043|OTHER|||||||0|||||||ANOVA|Factorial ANOVA used because variance could be assumed|||F(3,144)=55.89 Partial ETA squared (effect size)=0.54|||.000
72393181|NCT02970422|144294044|OTHER|||||||0|||||||ANOVA|One-way ANOVA|||F(3,142)=7.61|||.00
72393182|NCT02970422|144294045|OTHER|||||||0.31|||||||ANOVA|One-way ANOVA|||F(3,142)=1.21|||.31
72393183|NCT02970422|144294046|OTHER|||||||0.04|||||||Kruskal-Wallis|Non-parametric independent sample Kruskal-Wallis test (failed variance assumed|||F(3,139)=8.09|||.04
72393184|NCT02970422|144294047|OTHER|||||||0|||||||ANOVA|One-way ANOVA|||F(3,143)=8.01|||.00
72393185|NCT00410046|144294068|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||Admissions to hospital||||1.0
72393186|NCT00410046|144294068|SUPERIORITY_OR_OTHER|||||||0.23|||||||Fisher Exact|||Therapeutic warm bath sessions||||0.23
72393187|NCT00410046|144294068|SUPERIORITY_OR_OTHER|||||||0.567|||||||Fisher Exact|||Physiotherapist visits||||0.567
72462821|NCT01524887|144448465|SUPERIORITY_OR_OTHER_LEGACY||Difference in least square means|-0.5||||0.633||95.0|-2.8|1.7|||Mixed Models Analysis|||||1.7|-2.8|0.633
72393188|NCT00410046|144294068|SUPERIORITY_OR_OTHER|||||||0.475|||||||Fisher Exact|||Out-patient physician visit||||0.475
72393189|NCT00410046|144294069|SUPERIORITY_OR_OTHER|||||||0.628|||||||ANCOVA|One-way ANCOVA, baseline was a covariate.||Inpatient hospitalization days per patient||||0.628
72393190|NCT00410046|144294069|SUPERIORITY_OR_OTHER|||||||0.045|||||||ANCOVA|||Therapeutic warm bath sessions per patient||||0.045
72393191|NCT00410046|144294069|SUPERIORITY_OR_OTHER|||||||0.361|||||||ANCOVA|||Physiotherapist visits per patient||||0.361
72393192|NCT00410046|144294069|SUPERIORITY_OR_OTHER|||||||0.816|||||||ANCOVA|||Out-patient physician visit per patient||||0.816
72393193|NCT00410046|144294070|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||Analysis completed for patients with sick leave during the past 12 months||||1.00
72393194|NCT00410046|144294071|SUPERIORITY_OR_OTHER|||||||0.906|||||||ANCOVA|||||||0.906
72393195|NCT00410046|144294076|SUPERIORITY_OR_OTHER|||||||0.743||||||Comparison of Hospitalization 48 weeks before treatment Vs. Hospitalization during 48 treatment weeks|Fisher Exact|||||||0.743
72393196|NCT00410046|144294076|SUPERIORITY_OR_OTHER|||||||0.362||||||Comparison of Therapeutic warm bath 48 weeks before treatment Vs. Therapeutic warm bath during 48 treatment weeks|Fisher Exact|||Comparison of percentages||||0.362
72393197|NCT00410046|144294076|SUPERIORITY_OR_OTHER|||||||0.005||||||Comparison of Visit to physiotherapist 48 weeks before treatment Vs. Visit to physiotherapist during 48 treatment weeks|Fisher Exact|||||||0.005
72393198|NCT00410046|144294076|SUPERIORITY_OR_OTHER|||||||0.091||||||Comparison of Out-patient physician 48 weeks before treatment Vs. Out-patient physician during 48 treatment weeks|Fisher Exact|||||||0.091
72393199|NCT00410046|144294077|SUPERIORITY_OR_OTHER|||||||0.576||||||Comparison of Sick leave 48 weeks before treatment Vs. Sick leave during 48 weeks of treatment|Fisher Exact|||||||0.576
72393200|NCT00482612|144294106|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|Baseline TST was used as a covariate.||||||<0.0001
72393201|NCT00482612|144294106|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|Baseline TST was used as a covariate.||||||<0.0001
72393202|NCT00482612|144294106|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|Baseline TST was used as a covariate.||||||<0.0001
72393203|NCT00482612|144294107|SUPERIORITY_OR_OTHER|||||||0.0014|||||||ANCOVA|Baseline SL was used as a covariate.||||||0.0014
72393204|NCT00482612|144294107|SUPERIORITY_OR_OTHER|||||||0.0135|||||||ANCOVA|Baseline SL was used as a covariate.||||||0.0135
72393205|NCT00482612|144294107|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|Baseline SL was used as a covariate.||||||<0.0001
72393206|NCT00759031|144294139|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANOVA|||The null hypothesis states that there is no difference between groups.||||0.05
72393207|NCT00616200|144294142|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||ANOVA|||Sickness Impact Profile scores improved.||||.001
72393208|NCT00208091|144294143|SUPERIORITY_OR_OTHER||||||=|0.06||95.0|||||Wilcoxon (Mann-Whitney)|||||||=0.06
72462822|NCT01524887|144448465|SUPERIORITY_OR_OTHER_LEGACY||Difference in least square means|0.0||||0.981||95.0|-2.0|2.0|||Mixed Models Analysis|||||2.0|-2.0|0.981
72621137|NCT02732145|144773181|SUPERIORITY|Question: Is there a difference in the incidence of vulvar itching versus irritation in the patients with vulvar dermatosis?||||||0|||||||t-test proportion|||Parameter: The difference in the incidence of vulvar itching versus irritation in patients with vulvar dermatosis.||||0.0000
72393209|NCT00208091|144294144|SUPERIORITY_OR_OTHER||||||=|0.23||95.0|||||Wilcoxon (Mann-Whitney)|||||||=0.23
72393210|NCT01599234|144294146|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-0.23||||0.22||95.0|-0.59|0.14|||ANCOVA|||The initial model used for the analysis of the end of study value was an analysis of covariance (ANCOVA) with baseline as a covariate and treatment group, centre group, ambulatory status at baseline and previous use of cannabis as main effects. Interactions between the main effects were investigated, and if they had little influence then they were dropped from the model. These tests were performed at the 10% significance level as a possible indicator of an interactive effect.||0.14|-0.59|0.220
72393211|NCT01599234|144294147|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.341||||0.231|TWO_SIDED|95.0|0.83|2.167|||ANCOVA|||The numbers of responders was analysed using the difference in proportions and the odds ratio comparing the treatment groups with the provision of 95% CIs for the difference and odds ratio. The two groups were compared using ANCOVA with baseline severity as a covariate and study centre and treatment group as factors.||2.167|0.830|0.231
72393212|NCT01599234|144294148|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-0.16||||0.857|TWO_SIDED|95.0|-1.94|1.61|||ANCOVA|||The change at the end of treatment was compared between treatment groups using ANCOVA. The model included treatment, centre group and ambulatory status at baseline as factors and baseline score as a covariate.||1.61|-1.94|0.857
72393213|NCT01599234|144294149|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-0.07||||0.734|TWO_SIDED|95.0|-0.55|0.4|||ANCOVA|||The two groups were compared using ANCOVA with baseline severity as a covariate and study centre and treatment group as factors.||0.40|-0.55|0.734
72393214|NCT01599234|144294151|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|0.0||||0.624|TWO_SIDED|95.0|-2.0|1.0|||ANCOVA|||The change at end of treatment was compared between treatment groups using ANCOVA. The model included treatment, centre group and ambulatory status at baseline as factors and baseline score as a covariate.||1.0|-2.0|0.624
72393215|NCT01599234|144294152|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.248||||0.27|TWO_SIDED|95.0|0.842|1.849|||Regression, Logistic|||The two treatment groups were to be compared using ordinal logistic regression and the proportional odds model. The model was to incorporate ambulatory status at baseline and centre group.||1.849|0.842|0.270
72393216|NCT01599234|144294153|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-0.15||||0.867|TWO_SIDED|95.0|-1.95|1.64|||ANCOVA|||The change at the end of treatment was compared between treatment groups using ANCOVA. The model included treatment, centre group and ambulatory status at baseline as factors and baseline score as a covariate.||1.64|-1.95|0.867
72393217|NCT01599234|144294154|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.215||||0.569|TWO_SIDED|95.0|0.622|2.373|||ANCOVA|||The numbers of responders was analysed using the difference in proportions and the odds ratio comparing the treatment groups with the provision of 95% CIs for the difference and odds ratio. The two groups were compared using ANCOVA with baseline severity as a covariate and study centre and treatment group as factors.||2.373|0.622|0.569
72393218|NCT02033694|144294155|OTHER||Cox Proportional Hazard|1.21||||0.0004|TWO_SIDED|95.0|1.09|1.35|||Regression, Cox|||Hypothesis 1 (Vulnerable Patient Hypothesis) first fit a univariate proportional hazards regression model in which maxLCBI4mm is the only independent variable and NC-MACE during 2 years is the outcome. The null hypothesis tested by the Wald test that the regression coefficient in a proportional hazards regression model is significantly different from 0. This analysis determined whether maxLCBI4mmI is a risk factor for NC-MACE.||1.35|1.09|0.0004
72462823|NCT04341584|144448506|SUPERIORITY||Median posterior HR|0.97|||||TWO_SIDED|90.0|0.62|1.52|||Bayesian Cox model|adjusted for age and centre|% Confidence Interval is % Credible Interval here|||1.52|0.62|
72462824|NCT04341584|144448507|SUPERIORITY||Median posterior absolute risk differenc|-2.5|||||TWO_SIDED|90.0|-17.1|12.0|||Bayesian analysis||% Confidence Interval is % Credible Interval here|||12|-17.1|
72462825|NCT04341584|144448508|SUPERIORITY||Median posterior HR|1.26|||||TWO_SIDED|90.0|0.59|2.81||adjusted for age and centre|Bayesian Fine and Gray analysis||% Confidence interval is % Credible Interval here|||2.81|0.59|
72462826|NCT04341584|144448509|SUPERIORITY||Median posterior absolute risk differenc|24.0|||||TWO_SIDED|90.0|3.9|43.5|||Bayesian analysis||% Confidence interval is % Credible interval here|||43.5|3.9|
72462827|NCT04341584|144448510|SUPERIORITY||Median posterior OR|0.8|||||TWO_SIDED|95.0|0.38|1.68|||Bayesian Proportionnal odds model|Adjusted for age and centre|% Confidence interval is % Credible interval here|Day 4||1.68|0.38|
72462828|NCT04341584|144448510|SUPERIORITY||Median posterior OR|0.69|||||TWO_SIDED|95.0|0.33|1.43|||Bayesian Proportionnal odds model|Adjusted for age and centre|% Confidence interval is % Credible interval here|Day 14||1.43|0.33|
72462829|NCT04341584|144448510|SUPERIORITY||Median posterior OR|0.7|||||TWO_SIDED|95.0|0.35|1.38|||Bayesian Proportionnal odds model|Adjusted for age and centre|% Confidence interval is % Credible interval here|Day 28||1.38|0.35|
72462830|NCT04341584|144448510|SUPERIORITY||Median posterior OR|0.72|||||TWO_SIDED|95.0|0.22|2.39|||Bayesian Proportionnal odds model|Adjusted for age and centre|% Confidence Interval is % Credible interval here|Day 4||2.39|0.22|
72462831|NCT04341584|144448510|SUPERIORITY||Median posterior HR|0.89|||||TWO_SIDED|95.0|0.28|2.8|||Bayesian Proportionnal odds model|Adjusted for age and centre|% Confidence Interval is % Credible interval here|Day 7||2.80|0.28|
72462832|NCT04341584|144448510|SUPERIORITY||Median posterior HR|0.57|||||TWO_SIDED|95.0|0.18|1.75||Day 14|Bayesian Proportionnal odds model|Adjusted for afe and centre|% Confidence Interval is % Credible interval here|||1.75|0.18|
72462833|NCT04341584|144448511|SUPERIORITY||Hazard Ratio (HR)|0.56|||||TWO_SIDED|95.0|0.23|1.29|||Regression, Cox|adjusted for age and centre||14 days||1.29|0.23|
72462834|NCT04341584|144448511|SUPERIORITY||Hazard Ratio (HR)|0.77|||||TWO_SIDED|95.0|0.33|1.77|||Regression, Cox|Adjusted for age and centre||28 days||1.77|0.33|
72621138|NCT02732145|144773181|SUPERIORITY|||||||0||||||There was a statistically significant difference at p\<0.001. Patients with vulvar dermatosis had significantly more often itching than the feeling of inflammation of the vulva.|t-test proportion|||Parameter: The difference in the incidence of vulvar itching versus the feeling of inflammation in patients with vulvar dermatosis.||||0.0000
72393219|NCT02033694|144294155|OTHER||Cox Proportional Hazard|1.45|||<|0.0001|TWO_SIDED|95.0|1.3|1.6|||Regression, Cox|||Hypothesis 2 (Vulnerable Plaque Hypothesis) first fit a univariate proportional hazards regression model in which maxLCBI4mm in the coronary artery segment is the measure of exposure and NC-MACE during 2 years caused by a new culprit lesion in that segment is the outcome. This analysis was performed with adjustment for the potential clustering effect within patient utilizing the Wei, Lin and Weissfeld (WLW) methodology. This analysis determined whether maxLCBI4mm is a risk factor NC-MACE.||1.60|1.30|<0.0001
72462835|NCT04341584|144448511|SUPERIORITY|90 days|Hazard Ratio (HR)|0.97|||||TWO_SIDED|95.0|0.46|2.04|||Regression, Cox|adjusted on age and centre|% Confidence interval is % Credible interval here|||2.04|0.46|
72462836|NCT04341584|144448511|SUPERIORITY||Hazard Ratio (HR)|0.64|||||TWO_SIDED|95.0|0.11|3.86|||Regression, Cox|adjusted on age and centre||||3.86|0.11|
72462837|NCT04341584|144448511|SUPERIORITY||Hazard Ratio (HR)|0.94|||||TWO_SIDED|95.0|0.19|4.68|||Regression, Cox|adjusted on age and centre||||4.68|0.19|
72462838|NCT04341584|144448511|SUPERIORITY||Cox Proportional Hazard|1.22|||||TWO_SIDED|95.0|0.31|4.87|||Regression, Cox|adjusted on age and centre||||4.87|0.31|
72462839|NCT04341584|144448512|SUPERIORITY||Mean Difference (Net)|-0.4|||||TWO_SIDED|95.0|-8.3|6.4||||adjusted on age and centre||||6.4|-8.3|
72462840|NCT04341584|144448514|SUPERIORITY||Hazard Ratio (HR)|1.01|||||TWO_SIDED|95.0|0.64|1.61|||Fine-Gray model|Adjusted for age and centre||||1.61|0.64|
72462841|NCT04341584|144448514|SUPERIORITY||Hazard Ratio (HR)|1.33|||||TWO_SIDED|95.0|0.58|3.07||Adjusted for age and centre|Fine-Gray model|Adjusted for age and centre||||3.07|0.58|
72502025|NCT03617926|144533935|SUPERIORITY|In case superiority is not proven, non-inferiority is tested. As non-inferiority margin (δ), a 7.5% worse cure rate is regarded as clinically not relevant. The following null hypothesis will be used: H0, NI: pT-pR \< δ, whereby δ = -7.5%. The lower, 95% confidence interval of the difference pT-pR will be used for the test. If H0, NI will be rejected, non-inferiority cannot be shown.||||||0.023||||||A priori treshold p value of 0.05 for statistical significance was set prior to study start.|Chi-squared|||"Efficacy analyses is performed on the ITT population (all subjects who were included and randomized in the study, with available baseline value of the primary endpoint and at least one follow-up visit). All statistical tests are performed at a 5% level of significance. The aim of this analysis is to show superiority for the cure rate of the test product versus a predefined limit of 70%. The following null hypothesis will be tested: H0, prim: pT - pR = 0 and Ha: pT - pR \> 15%~I"||||0.023
72502026|NCT02015819|144533988|OTHER||||||||||||||||||MFD was determined to be 1.5x10\^8 in combination with oral 5-FC 37.5 mg/kg and leucovorin 25 mg every 6 hours for 7 days.|||
72502027|NCT00283387|144534011|SUPERIORITY_OR_OTHER|||||||0.007||95.0|||||t-test, 2 sided|||||||0.007
72502028|NCT03584009|144534013|SUPERIORITY||Risk Difference (RD)|-1.96||||0.7286|TWO_SIDED|95.0|-16.86|12.94||P-value is based on Stratified Analysis (Stratified by BCL2 status (High vs Low) and Lines of Therapy (2 vs 1)).|Cochran-Mantel-Haenszel|||||12.94|-16.86|0.7286
72563777|NCT02688387|144658902|EQUIVALENCE|Part 3B of the study is set to establish bioequivalence between the Fixed Dose Combination of an additional two dose strengths (ambrisentan 5 mg + tadalafil 40 mg and ambrisentan 5 mg + tadalafil 20 mg).|Ratio|1.0351|||||TWO_SIDED|90.0|1.0002|1.0713|||||Y2 Vs R4, ambrisentan|||1.0713|1.0002|
72462842|NCT04341584|144448515|SUPERIORITY||Hazard Ratio (HR)|0.91|||||TWO_SIDED|95.0|0.56|1.48|||Fine-Gray model|adjusted on age and centre||||1.48|0.56|
72462843|NCT04341584|144448515|SUPERIORITY||Hazard Ratio (HR)|0.9|||||TWO_SIDED|95.0|0.35|2.34||adjusted on age and centre|Fine-Gray model|||||2.34|0.35|
72462844|NCT04341584|144448516|SUPERIORITY||Hazard Ratio (HR)|1.0|||||TWO_SIDED|95.0|0.43|2.32||adjusted on age and centre|Fine-Gray model|||Day 28||2.32|0.43|
72462845|NCT04341584|144448516|SUPERIORITY||Hazard Ratio (HR)|1.09|||||TWO_SIDED|95.0|0.52|2.29||adjusted on age and centre|Fine-Gray model|||Day 90||2.29|0.52|
72462846|NCT02081196|144448569|OTHER||Mean Difference (Net)|4.13|STANDARD_DEVIATION|2.45|||TWO_SIDED|95.0|3.08|4.77|||||Treatment Effect =Control Flank Change-Treated Flank Change such (a positive results indicates treated area had a larger reduction in fat thickness than control area, and a negative result indicates that a greater reduction was seen in control area).|H0: μ(Control - Treated) \< +1 versus H1: μ(Control - Treated) \> +1||4.77|3.08|
72462847|NCT02081196|144448570|OTHER||sucess proportion|0.8476|||||TWO_SIDED|95.0|0.784|0.913|||||||Descriptive statistics (tabulation of Independent Panel Reviewer ratings) were used to analyze data.|.913|.784|
72462848|NCT02924350|144448623|OTHER||Least square (LS) mean difference|-0.924|||<|0.0001|TWO_SIDED|95.0|-1.0547|-0.7927|||ANCOVA|ANCOVA: change from baseline in Schiff sensitivity score as response and treatment as a factor and baseline Schiff sensitivity score as a covariate|Difference is first named dentifrice minus second named dentifrice such that a negative difference favors first named dentifrice.|||-0.7927|-1.0547|<.0001
72462849|NCT00097708|144448626|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.4||||0.654|TWO_SIDED|95.0|-2.2|1.4|||ANCOVA|||||1.4|-2.2|0.6540
72462850|NCT00097708|144448626|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.2||||0.0005|TWO_SIDED|95.0|-5.0|-1.4|||ANCOVA|||||-1.4|-5.0|0.0005
72462851|NCT00097708|144448626|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.8||||0.0015|TWO_SIDED|95.0|1.1|4.5|||ANCOVA|||||4.5|1.1|0.0015
72462852|NCT01589523|144448635|EQUIVALENCE|paired t-test||||||0.342|||||||t-test, 2 sided|||||||0.342
72502029|NCT03584009|144534014|SUPERIORITY||Hazard Ratio (HR)|0.94||||0.7853|TWO_SIDED|95.0|0.61|1.45||P-value is based on Stratified Analysis (Stratified by BCL2 status (High vs Low) and Lines of Therapy (2 vs 1)).|Regression, Cox|||||1.45|0.61|0.7853
72502030|NCT03584009|144534015|SUPERIORITY||Risk Difference (RD)|-1.96||||0.5978|TWO_SIDED|95.0|-12.29|8.37||P-value is based on Stratified Analysis (Stratified by BCL2 status (High vs Low) and Lines of Therapy (2 vs 1)).|Cochran-Mantel-Haenszel|||||8.37|-12.29|0.5978
72502031|NCT03584009|144534017|SUPERIORITY||Hazard Ratio (HR)|1.87||||0.0403|TWO_SIDED|95.0|1.02|3.43||P-value is based on Stratified Analysis (Stratified by BCL2 status (High vs Low) and Lines of Therapy (2 vs 1)).|Log Rank||Hazard ratios were estimated by Cox regression.|||3.43|1.02|0.0403
72502032|NCT02886715|144534024|EQUIVALENCE|90% Confidence Interval for the least-squares mean Test/Reference ratios to be within 80-125%|Test-to-Reference Ratio|98.75|||||TWO_SIDED|90.0|94.39|103.31||p-value was no calculated|ANOVA|with treatment and site as fixed effects in the model||||103.31|94.39|
72462853|NCT01589523|144448636|EQUIVALENCE|paired t-test||||||0.116|||||||t-test, 2 sided|||||||0.116
72621139|NCT02732145|144773181|SUPERIORITY|Question: Is there a difference in the incidence of vulvar itching versus aching in the patients with vulvar dermatosis?||||||0|||||||t-test proportion|||Parameter: The difference in the incidence of vulvar itching versus aching in patients with vulvar dermatosis.||||0.0000
72621140|NCT02732145|144773181|SUPERIORITY|Question: Is there a difference in the incidence of vulvar stinging versus burning in the patients with vulvar dermatosis?||||||0|||||||t-test proportion|||Parameter: The difference in the incidence of vulvar stinging versus burning in patients with vulvar dermatosis.||||0.0000
72621141|NCT02732145|144773181|SUPERIORITY|Question: Is there a difference in the incidence of vulvar stinging versus soreness in the patients with vulvar dermatosis?||||||0|||||||t-test proportion|||Parameter: The difference in the incidence of vulvar stinging versus soreness in patients with vulvar dermatosis.||||0.0000
72462854|NCT01589523|144448637|EQUIVALENCE|paired t-test||||||0.065|||||||t-test, 2 sided|vitamin D||||||0.065
72462855|NCT02675998|144448655|SUPERIORITY|||||||0.01|||||||ANCOVA|||||||0.01
72621142|NCT02732145|144773181|SUPERIORITY|Question: Is there a difference in the incidence of vulvar stinging versus irritation in the patients with vulvar dermatosis?||||||0|||||||t-test proportion|||Parameter: The difference in the incidence of vulvar stinging versus irritation in patients with vulvar dermatosis.||||0.0000
72393220|NCT02033694|144294156|OTHER||Cox Proportional Hazard|2.18|||<|0.0001|TWO_SIDED|95.0|1.48|3.22|||Regression, Cox|||Secondary Hypothesis 1 (Vulnerable Patient)- Cox proportional hazards regression model to assess a threshold of maxLCBI4mm \> 400 as the independent variable and NC-MACE during 2 years as the outcome.||3.22|1.48|<0.0001
72462856|NCT02675998|144448656|SUPERIORITY||||||<|0.001|||||||ANCOVA|||||||<0.001
72502033|NCT02886715|144534024|SUPERIORITY||Mean Difference (Final Values)|-5.17||||0.0185|TWO_SIDED|95.0|-9.46|-0.87|||ANOVA|with treatment and site as fixed effects in the model||||-0.87|-9.46|0.0185
72462857|NCT02675998|144448656|SUPERIORITY||||||<|0.001|||||||ANCOVA|||||||<0.001
72462858|NCT02675998|144448656|SUPERIORITY||||||<|0.001|||||||ANCOVA|||||||<0.001
72462859|NCT04357964|144448657|EQUIVALENCE|Statistical significance was defined as p\< 0.05 for determining difference between groups at baseline in this observational study. There was no treatment intervention in this study, so there is no true equivalence margin.|||||<|0.01||||||Statistical significance was defined as p\< 0.05|Kruskal-Wallis|||||||<0.01
72462860|NCT04357964|144448658|EQUIVALENCE|Statistical significance was defined as p \< 0.05. There was no intervention in this study, so there is no true equivalence margin.|||||<|0.01|||||||Pearson correlation|||||||<0.01
72621143|NCT02732145|144773181|SUPERIORITY|Question: Is there a difference in the incidence of vulvar stinging versus the feeling of inflammation in the patients with vulvar dermatosis?||||||0|||||||t-test proportion|||Parameter: The difference in the incidence of vulvar stinging versus the feeling of inflammation in patients with vulvar dermatosis.||||0.0000
72621144|NCT02732145|144773181|SUPERIORITY|Question: Is there a difference in the incidence of vulvar stinging versus aching in the patients with vulvar dermatosis?||||||0|||||||t-test proportion|||Parameter: The difference in the incidence of vulvar stinging versus aching in patients with vulvar dermatosis.||||0.0000
72621145|NCT02732145|144773181|SUPERIORITY|Question: Is there a difference in the incidence of vulvar aching versus burning in the patients with vulvar dermatosis?||||||0.8591|||||||t-test proportion|||Parameter: The difference in the incidence of vulvar aching versus burning in patients with vulvar dermatosis.||||0.8591
72462861|NCT04357964|144448659|EQUIVALENCE|Statistical significance was defined as p\< 0.05 for determining difference between groups in this observational study. There was no treatment intervention in this study, so there is no true equivalence margin.||||||0.52||||||Statistical significance was defined as p\< 0.05|Kruskal-Wallis|||||||0.52
72462862|NCT02288364|144448669|SUPERIORITY_OR_OTHER|||||||0.3|TWO_SIDED||||||Chi-squared|||||||0.30
72462863|NCT02288364|144448670|SUPERIORITY_OR_OTHER|||||||0.08|TWO_SIDED||||||Chi-squared|||||||0.08
72462864|NCT02288364|144448671|SUPERIORITY_OR_OTHER|||||||0.29|TWO_SIDED||||||Chi-squared|||||||0.29
72462865|NCT00043186|144448678|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.87|||<|0.001||95.0|4.59|7.16|||ANCOVA|||||7.16|4.59|<0.001
72462866|NCT00043186|144448678|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.33|||<|0.001||95.0|5.01|7.65|||ANCOVA|||||7.65|5.01|<0.001
72462867|NCT00043186|144448678|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.35|||<|0.001||95.0|4.07|6.64|||ANCOVA|||||6.64|4.07|<0.001
72462868|NCT00043186|144448678|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.84|||<|0.001||95.0|2.6|5.07|||ANCOVA|||||5.07|2.60|<0.001
72462869|NCT00043186|144448678|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.5|||<|0.001||95.0|6.13|8.87|||ANCOVA|||||8.87|6.13|<0.001
72502034|NCT02886715|144534026|EQUIVALENCE|90% Confidence Interval for the least-squares mean Test/Reference ratios to be within 80-125%|Test-to-Reference Ratio|98.39|||||TWO_SIDED|90.0|93.42|103.61||p-value was no calculated|ANOVA|with treatment and site as fixed effects in the model||||103.61|93.42|
72621146|NCT02732145|144773181|SUPERIORITY|Question: Is there a difference in the incidence of vulvar aching versus soreness in the patients with vulvar dermatosis?||||||0.009|||||||t-test proportion|||Parameter: The difference in the incidence of vulvar aching versus soreness in patients with vulvar dermatosis.||||0.0090
72462870|NCT00043186|144448678|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.52|||<|0.001||95.0|4.19|6.85|||ANCOVA|||||6.85|4.19|<0.001
72462871|NCT00043186|144448678|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.21|||<|0.001||95.0|3.88|6.55|||ANCOVA|||||6.55|3.88|<0.001
72393221|NCT02033694|144294156|OTHER||Cox Proportional Hazard|4.22|||<|0.0001|TWO_SIDED|95.0|2.39|7.45|||Regression, Cox|||Secondary Hypothesis 2 (Vulnerable Plaque)- Cox proportional hazards regression model to assess a threshold of maxLCBI4mm \> 400 in the coronary artery segment as the independent variable and NC-MACE during 2 years caused by a new culprit lesion in that segment is the outcome.||7.45|2.39|<0.0001
72393222|NCT02899988|144294157|SUPERIORITY||Risk Difference (RD)|29.4||||0.009|TWO_SIDED|95.0|16.9|41.9|||Regression, Logistic|||||41.9|16.9|0.009
72393223|NCT02899988|144294157|SUPERIORITY||Risk Difference (RD)|58.8|||<|0.001|TWO_SIDED|95.0|45.3|72.3|||Regression, Logistic|||||72.3|45.3|<0.001
72393224|NCT02899988|144294157|SUPERIORITY||Risk Difference (RD)|66.7|||<|0.001|TWO_SIDED|95.0|53.7|79.6|||Regression, Logistic|||||79.6|53.7|<0.001
72393225|NCT02899988|144294158|SUPERIORITY||Risk Difference (RD)|15.7||||0.039|TWO_SIDED|95.0|5.7|25.7|||Regression, Logistic|||||25.7|5.7|0.039
72393226|NCT02899988|144294158|SUPERIORITY||Risk Difference (RD)|31.4||||0.007|TWO_SIDED|95.0|18.6|44.1|||Regression, Logistic|||||44.1|18.6|0.007
72393227|NCT02899988|144294158|SUPERIORITY||Risk Difference (RD)|31.4||||0.007|TWO_SIDED|95.0|18.6|44.1|||Regression, Logistic|||||44.1|18.6|0.007
72393228|NCT02899988|144294159|SUPERIORITY||Risk Difference (RD)|22.49|||<|0.001|TWO_SIDED|95.0|5.62|89.97|||Regression, Logistic|||||89.97|5.62|<0.001
72393229|NCT02899988|144294159|SUPERIORITY||Risk Difference (RD)|74.6|||<|0.001|TWO_SIDED|95.0|62.1|87.0|||Regression, Logistic|||||87.0|62.1|<0.001
72393230|NCT02899988|144294159|SUPERIORITY||Risk Difference (RD)|70.7|||<|0.001|TWO_SIDED|95.0|57.6|83.7|||Regression, Logistic|||||83.7|57.6|<0.001
72393231|NCT02899988|144294160|SUPERIORITY||Risk Difference (RD)|15.7||||0.041|TWO_SIDED|95.0|5.7|25.7|||Regression, Logistic|||sPGA (0)||25.7|5.7|0.041
72462872|NCT00043186|144448679|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
72462873|NCT00043186|144448679|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
72462874|NCT00043186|144448679|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
72462875|NCT00043186|144448679|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
72462876|NCT00043186|144448679|SUPERIORITY_OR_OTHER|||||||0.166|||||||Wilcoxon (Mann-Whitney)|||||||0.166
72462877|NCT00043186|144448679|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
72462878|NCT00043186|144448679|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
72462879|NCT00043186|144448679|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
72462880|NCT00043186|144448680|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
72462881|NCT00043186|144448680|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
72462882|NCT00043186|144448680|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
72462883|NCT00043186|144448680|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
72462884|NCT00043186|144448680|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
72462885|NCT00043186|144448680|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
72462886|NCT00043186|144448680|SUPERIORITY_OR_OTHER|||||||0.02|||||||Wilcoxon (Mann-Whitney)|||||||0.020
72462887|NCT00043186|144448680|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
72462888|NCT00043186|144448682|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.34|||<|0.001||95.0|5.56|9.12|||ANCOVA|||||9.12|5.56|<0.001
72462889|NCT00043186|144448682|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.11|||<|0.001||95.0|7.31|10.91|||ANCOVA|||||10.91|7.31|<0.001
72462890|NCT00043186|144448682|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.56|||<|0.001||95.0|6.71|10.41|||ANCOVA|||||10.41|6.71|<0.001
72462891|NCT00043186|144448682|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.44|||<|0.001||95.0|6.69|10.19|||ANCOVA|||||10.19|6.69|<0.001
72462892|NCT00043186|144448682|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.19|||<|0.001||95.0|3.43|6.94|||ANCOVA|||||6.94|3.43|<0.001
72462893|NCT00043186|144448682|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.08|||<|0.001||95.0|8.14|12.01|||ANCOVA|||||12.01|8.14|<0.001
72462894|NCT00043186|144448682|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.46|||<|0.001||95.0|6.62|10.3|||ANCOVA|||||10.30|6.62|<0.001
72462895|NCT00043186|144448682|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.66|||<|0.001||95.0|6.8|10.53|||ANCOVA|||||10.53|6.80|<0.001
72462896|NCT00043186|144448683|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.5|||<|0.001||95.0|4.32|8.67|||ANCOVA|||||8.67|4.32|<0.001
72462897|NCT00043186|144448683|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.65||||0.013||95.0|0.55|4.75|||ANCOVA|||||4.75|0.55|0.013
72462898|NCT00043186|144448683|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.43|||<|0.001||95.0|10.19|14.68|||ANCOVA|||||14.68|10.19|<0.001
72462899|NCT00043186|144448683|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.84|||<|0.001||95.0|8.74|12.94|||ANCOVA|||||12.94|8.74|<0.001
72462900|NCT00043186|144448683|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.79|||<|0.001||95.0|7.69|11.89|||ANCOVA|||||11.89|7.69|<0.001
72462901|NCT00043186|144448683|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.74|||<|0.001||95.0|1.37|6.12|||ANCOVA|||||6.12|1.37|<0.001
72462902|NCT00043186|144448683|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.97|||<|0.001||95.0|8.63|13.32|||ANCOVA|||||13.32|8.63|<0.001
72462903|NCT00043186|144448683|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.37|||<|0.001||95.0|8.16|12.59|||ANCOVA|||||12.59|8.16|<0.001
72462904|NCT00043186|144448684|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.42||||0.02||95.0|0.89|9.95|||ANCOVA|||||9.95|0.89|0.02
72462905|NCT00043186|144448684|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.03||||0.992||95.0|-5.07|5.02|||ANCOVA|||||5.02|-5.07|0.992
72462906|NCT00043186|144448684|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.9||||0.004||95.0|3.72|14.09|||ANCOVA|||||14.09|3.72|0.004
72462907|NCT00043186|144448684|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.5||||0.001||95.0|4.15|12.86|||ANCOVA|||||12.86|4.15|0.001
72563778|NCT02688387|144658902|EQUIVALENCE|Part 3B of the study is set to establish bioequivalence between the Fixed Dose Combination of an additional two dose strengths (ambrisentan 5 mg + tadalafil 40 mg and ambrisentan 5 mg + tadalafil 20 mg).|Ratio|1.0324|||||TWO_SIDED|90.0|0.9929|1.0734|||||Y2 Vs R4, tadalafil|||1.0734|0.9929|
72563779|NCT04403399|144658978|SUPERIORITY||Mean Difference (Final Values)|-3.62||||0.003|TWO_SIDED||||||Mixed Models Analysis|||||||0.003
72563780|NCT04403399|144658979|SUPERIORITY||Mean Difference (Final Values)|-0.07||||0.73|TWO_SIDED||||||Mixed Models Analysis|||||||0.73
72563781|NCT04403399|144658980|SUPERIORITY||Mean Difference (Final Values)|0.08||||0.03|TWO_SIDED||||||Mixed Models Analysis|||||||0.03
72462908|NCT00043186|144448684|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.37||||0.001||95.0|4.11|12.63|||ANCOVA|||||12.63|4.11|0.001
72563782|NCT04100096|144658994|SUPERIORITY||Least Square (LS) Mean Difference|-1.02||||0.243|TWO_SIDED|95.0|-2.75|0.7||Comparison was carried out using MMRM, with study center (pooled), treatment group (TG), visit, ADT status, and TG by visit interaction (BVI), gender BVI, age BVI as factors and baseline BVI as covariate. An unstructured covariance was used.|MMRM|||||0.70|-2.75|0.2430
72563783|NCT04100096|144658995|SUPERIORITY||LS Mean Difference|-0.04||||0.7759|TWO_SIDED|95.0|-0.35|0.27||Comparison was carried out using MMRM, with study center (pooled), TG, visit, ADT status, and TG BVI, gender BVI, age BVI as factors and baseline BVI as covariate. An unstructured covariance was used.|MMRM|||||0.27|-0.35|0.7759
72621147|NCT02732145|144773181|SUPERIORITY|Question: Is there a difference in the incidence of vulvar aching versus irritation in the patients with vulvar dermatosis?||||||0.0212|||||||t-test proportion|||Parameter: The difference in the incidence of vulvar aching versus irritation in patients with vulvar dermatosis.||||0.0212
72621148|NCT02732145|144773181|SUPERIORITY|Question: Is there a difference in the incidence of vulvar aching versus the feeling of inflammation in the patients with vulvar dermatosis?||||||0.0057|||||||t-test proportion|||Parameter: The difference in the incidence of vulvar aching versus the feeling of inflammation in patients with vulvar dermatosis.||||0.0057
72462909|NCT00043186|144448684|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.98||||0.292||95.0|-1.42|9.37|||ANCOVA|||||9.37|-1.42|0.292
72462910|NCT00043186|144448684|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.95||||0.004||95.0|3.94|13.96|||ANCOVA|||||13.96|3.94|0.004
72462911|NCT00043186|144448684|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.12||||0.094||95.0|0.57|11.67|||ANCOVA|||||11.67|0.57|0.094
72462912|NCT00043186|144448685|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.93|||<|0.001||95.0|3.97|9.89|||ANCOVA|||||9.89|3.97|<0.001
72462913|NCT00043186|144448685|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.89|||<|0.001||95.0|1.92|7.85|||ANCOVA|||||7.85|1.92|<0.001
72462914|NCT00043186|144448685|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.15|||<|0.001||95.0|11.08|17.21|||ANCOVA|||||17.21|11.08|<0.001
72462915|NCT00043186|144448685|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.73|||<|0.001||95.0|9.94|15.52|||ANCOVA|||||15.52|9.94|<0.001
72462916|NCT00043186|144448685|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.49|||<|0.001||95.0|9.66|15.32|||ANCOVA|||||15.32|9.66|<0.001
72462917|NCT00043186|144448685|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.42|||<|0.001||95.0|8.12|14.73|||ANCOVA|||||14.73|8.12|<0.001
72462918|NCT00043186|144448685|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.32|||<|0.001||95.0|9.15|15.49|||ANCOVA|||||15.49|9.15|<0.001
72462919|NCT00043186|144448685|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.74|||<|0.001||95.0|8.72|14.76|||ANCOVA|||||14.76|8.72|<0.001
72462920|NCT00043186|144448686|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
72462921|NCT00043186|144448686|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
72462922|NCT00043186|144448686|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
72462923|NCT00043186|144448686|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
72462924|NCT00043186|144448686|SUPERIORITY_OR_OTHER|||||||0.622|||||||Wilcoxon (Mann-Whitney)|||||||0.622
72462925|NCT00043186|144448686|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
72462926|NCT00043186|144448686|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
72462927|NCT00043186|144448686|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
72462928|NCT00043186|144448687|SUPERIORITY_OR_OTHER|||||||0.011|||||||Wilcoxon (Mann-Whitney)|||||||0.011
72462929|NCT00043186|144448687|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
72462930|NCT00043186|144448687|SUPERIORITY_OR_OTHER|||||||0.026|||||||Wilcoxon (Mann-Whitney)|||||||0.026
72563784|NCT04100096|144658996|SUPERIORITY||LS Mean Difference|-0.06||||0.6585|TWO_SIDED|95.0|-0.32|0.2||Derived from an MMRM with fixed effects of treatment, (pooled) trial site, visit, ADT status (with/without background ADT), treatment BVI, gender BVI, covariates of baseline BVI and age BVI.|MMRM||Derived from an MMRM with fixed effects of treatment, (pooled) trial site, visit, ADT status (with/without background ADT), treatment BVI, gender BVI, covariates of baseline BVI and age BVI.|Week 2||0.20|-0.32|0.6585
72563785|NCT04100096|144658996|SUPERIORITY||LS Mean Difference|-0.25||||0.1181|TWO_SIDED|95.0|-0.57|0.06||Derived from an MMRM with fixed effects of treatment, (pooled) trial site, visit, ADT status (with/without background ADT), treatment BVI, gender BVI, covariates of baseline BVI and age BVI.|MMRM||Derived from an MMRM with fixed effects of treatment, (pooled) trial site, visit, ADT status (with/without background ADT), treatment BVI, gender BVI, covariates of baseline BVI and age BVI.|Week 4||0.06|-0.57|0.1181
72563786|NCT04100096|144658996|SUPERIORITY||LS Mean Difference|-0.19||||0.2431|TWO_SIDED|95.0|-0.51|0.13||Derived from an MMRM with fixed effects of treatment, (pooled) trial site, visit, ADT status (with/without background ADT), treatment BVI, gender BVI, covariates of baseline BVI and age BVI.|MMRM||Derived from an MMRM with fixed effects of treatment, (pooled) trial site, visit, ADT status (with/without background ADT), treatment BVI, gender BVI, covariates of baseline BVI and age BVI.|Week 6||0.13|-0.51|0.2431
72563787|NCT04100096|144658996|SUPERIORITY||LS Mean Difference|-0.3||||0.0638|TWO_SIDED|95.0|-0.61|0.02||Derived from an MMRM with fixed effects of treatment, (pooled) trial site, visit, ADT status (with/without background ADT), treatment BVI, gender BVI, covariates of baseline BVI and age BVI.|MMRM||Derived from an MMRM with fixed effects of treatment, (pooled) trial site, visit, ADT status (with/without background ADT), treatment BVI, gender BVI, covariates of baseline BVI and age BVI.|Week 8||0.02|-0.61|0.0638
72462931|NCT00043186|144448687|SUPERIORITY_OR_OTHER|||||||0.003|||||||Wilcoxon (Mann-Whitney)|||||||0.003
72462932|NCT00043186|144448687|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
72462933|NCT00043186|144448687|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
72462934|NCT00043186|144448687|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
72462935|NCT00043186|144448687|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
72462936|NCT00043186|144448688|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
72462937|NCT00043186|144448688|SUPERIORITY_OR_OTHER|||||||0.012|||||||Wilcoxon (Mann-Whitney)|||||||0.012
72462938|NCT00043186|144448688|SUPERIORITY_OR_OTHER|||||||0.012|||||||Wilcoxon (Mann-Whitney)|||||||0.012
72462939|NCT00043186|144448688|SUPERIORITY_OR_OTHER|||||||0.002|||||||Wilcoxon (Mann-Whitney)|||||||0.002
72621149|NCT02732145|144773181|SUPERIORITY|Question: Is there a difference in the incidence of vulvar sticking versus knife-like pain in the patients with vulvar dermatosis who had sharp pain?||||||0.0977|||||||t-test proportion|||Parameter: The difference in the incidence of vulvar sticking versus knife-like pain in patients with vulvar dermatosis who had sharp vulvar pain.||||0.0977
72462940|NCT00043186|144448688|SUPERIORITY_OR_OTHER|||||||0.012|||||||Wilcoxon (Mann-Whitney)|||||||0.012
72462941|NCT00043186|144448688|SUPERIORITY_OR_OTHER|||||||0.012|||||||Wilcoxon (Mann-Whitney)|||||||0.012
72462942|NCT00043186|144448688|SUPERIORITY_OR_OTHER|||||||0.004|||||||Wilcoxon (Mann-Whitney)|||||||0.004
72462943|NCT00043186|144448688|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
72462944|NCT00043186|144448689|SUPERIORITY_OR_OTHER|||||||0.015|||||||Wilcoxon (Mann-Whitney)|||||||0.015
72462945|NCT00043186|144448689|SUPERIORITY_OR_OTHER|||||||0.05|||||||Wilcoxon (Mann-Whitney)|||||||0.050
72462946|NCT00043186|144448689|SUPERIORITY_OR_OTHER|||||||0.029|||||||Wilcoxon (Mann-Whitney)|||||||0.029
72462947|NCT00043186|144448689|SUPERIORITY_OR_OTHER|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||||||0.001
72462948|NCT00043186|144448689|SUPERIORITY_OR_OTHER|||||||0.032|||||||Wilcoxon (Mann-Whitney)|||||||0.032
72462949|NCT00043186|144448689|SUPERIORITY_OR_OTHER|||||||0.05|||||||Wilcoxon (Mann-Whitney)|||||||0.050
72462950|NCT00043186|144448689|SUPERIORITY_OR_OTHER|||||||0.05|||||||Wilcoxon (Mann-Whitney)|||||||0.050
72462951|NCT00043186|144448689|SUPERIORITY_OR_OTHER|||||||0.073|||||||Wilcoxon (Mann-Whitney)|||||||0.073
72462952|NCT00043186|144448690|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
72462953|NCT00043186|144448690|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
72462954|NCT00043186|144448690|SUPERIORITY_OR_OTHER|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||||||0.001
72462955|NCT00043186|144448690|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
72462956|NCT00043186|144448690|SUPERIORITY_OR_OTHER|||||||0.409|||||||Wilcoxon (Mann-Whitney)|||||||0.409
72462957|NCT00043186|144448690|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
72462958|NCT00043186|144448690|SUPERIORITY_OR_OTHER|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||||||0.001
72462959|NCT00043186|144448690|SUPERIORITY_OR_OTHER|||||||0.003|||||||Wilcoxon (Mann-Whitney)|||||||0.003
72462960|NCT00043186|144448691|SUPERIORITY_OR_OTHER|||||||0.011|||||||Wilcoxon (Mann-Whitney)|||||||0.011
72462961|NCT00043186|144448691|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
72462962|NCT00043186|144448691|SUPERIORITY_OR_OTHER|||||||0.077|||||||Wilcoxon (Mann-Whitney)|||||||0.077
72462963|NCT00043186|144448691|SUPERIORITY_OR_OTHER|||||||0.002|||||||Wilcoxon (Mann-Whitney)|||||||0.002
72462964|NCT00043186|144448691|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
72462965|NCT00043186|144448691|SUPERIORITY_OR_OTHER|||||||0.002|||||||Wilcoxon (Mann-Whitney)|||||||0.002
72462966|NCT00043186|144448691|SUPERIORITY_OR_OTHER|||||||0.002|||||||Wilcoxon (Mann-Whitney)|||||||0.002
72462967|NCT00043186|144448691|SUPERIORITY_OR_OTHER|||||||0.005|||||||Wilcoxon (Mann-Whitney)|||||||0.005
72462968|NCT00043186|144448692|SUPERIORITY_OR_OTHER|||||||0.053|||||||Wilcoxon (Mann-Whitney)|||||||0.053
72462969|NCT00043186|144448692|SUPERIORITY_OR_OTHER|||||||0.053|||||||Wilcoxon (Mann-Whitney)|||||||0.053
72462970|NCT00043186|144448692|SUPERIORITY_OR_OTHER|||||||0.022|||||||Wilcoxon (Mann-Whitney)|||||||0.022
72462971|NCT00043186|144448692|SUPERIORITY_OR_OTHER|||||||0.032|||||||Wilcoxon (Mann-Whitney)|||||||0.032
72462972|NCT00043186|144448692|SUPERIORITY_OR_OTHER|||||||0.053|||||||Wilcoxon (Mann-Whitney)|||||||0.053
72462973|NCT00043186|144448692|SUPERIORITY_OR_OTHER|||||||0.053|||||||Wilcoxon (Mann-Whitney)|||||||0.053
72462974|NCT00043186|144448692|SUPERIORITY_OR_OTHER|||||||0.02|||||||Wilcoxon (Mann-Whitney)|||||||0.020
72462975|NCT00043186|144448692|SUPERIORITY_OR_OTHER|||||||0.053|||||||Wilcoxon (Mann-Whitney)|||||||0.053
72462976|NCT00043186|144448693|SUPERIORITY_OR_OTHER|||||||0.01|||||||Wilcoxon (Mann-Whitney)|||||||0.010
72462977|NCT00043186|144448693|SUPERIORITY_OR_OTHER|||||||0.172|||||||Wilcoxon (Mann-Whitney)|||||||0.172
72462978|NCT00043186|144448693|SUPERIORITY_OR_OTHER|||||||0.029|||||||Wilcoxon (Mann-Whitney)|||||||0.029
72462979|NCT00043186|144448693|SUPERIORITY_OR_OTHER|||||||0.047|||||||Wilcoxon (Mann-Whitney)|||||||0.047
72462980|NCT00043186|144448693|SUPERIORITY_OR_OTHER|||||||0.015|||||||Wilcoxon (Mann-Whitney)|||||||0.015
72462981|NCT00043186|144448693|SUPERIORITY_OR_OTHER|||||||0.168|||||||Wilcoxon (Mann-Whitney)|||||||0.168
72462982|NCT00043186|144448693|SUPERIORITY_OR_OTHER|||||||0.168|||||||Wilcoxon (Mann-Whitney)|||||||0.168
72462983|NCT00043186|144448693|SUPERIORITY_OR_OTHER|||||||0.172|||||||Wilcoxon (Mann-Whitney)|||||||0.172
72462984|NCT00043186|144448694|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.67|||<|0.001||95.0|1.7|3.64|||ANCOVA|||||3.64|1.70|<0.001
72462985|NCT00043186|144448694|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.9|||<|0.001||95.0|1.9|3.89|||ANCOVA|||||3.89|1.90|<0.001
72462986|NCT00043186|144448694|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.09|||<|0.001||95.0|2.07|4.11|||ANCOVA|||||4.11|2.07|<0.001
72462987|NCT00043186|144448694|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.12|||<|0.001||95.0|3.13|5.11|||ANCOVA|||||5.11|3.13|<0.001
72462988|NCT00043186|144448694|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.5|||<|0.001||95.0|1.55|3.46|||ANCOVA|||||3.46|1.55|<0.001
72462989|NCT00043186|144448694|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.89|||<|0.001||95.0|2.83|4.95|||ANCOVA|||||4.95|2.83|<0.001
72462990|NCT00043186|144448694|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.01|||<|0.001||95.0|1.99|4.04|||ANCOVA|||||4.04|1.99|<0.001
72462991|NCT00043186|144448694|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.46|||<|0.001||95.0|2.43|4.48|||ANCOVA|||||4.48|2.43|<0.001
72462992|NCT00043186|144448695|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.19|||<|0.001||95.0|4.04|6.34|||ANCOVA|||||6.34|4.04|<0.001
72462993|NCT00043186|144448695|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.1|||<|0.001||95.0|4.93|7.27|||ANCOVA|||||7.27|4.93|<0.001
72462994|NCT00043186|144448695|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.59|||<|0.001||95.0|4.4|6.78|||ANCOVA|||||6.78|4.40|<0.001
72462995|NCT00043186|144448695|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.89|||<|0.001||95.0|5.76|8.01|||ANCOVA|||||8.01|5.76|<0.001
72462996|NCT00043186|144448695|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.54|||<|0.001||95.0|3.41|5.67|||ANCOVA|||||5.67|3.41|<0.001
72462997|NCT00043186|144448695|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.95|||<|0.001||95.0|5.69|8.21|||ANCOVA|||||8.21|5.69|<0.001
72462998|NCT00043186|144448695|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.48|||<|0.001||95.0|4.29|6.67|||ANCOVA|||||6.67|4.29|<0.001
72462999|NCT00043186|144448695|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.97|||<|0.001||95.0|4.76|7.17|||ANCOVA|||||7.17|4.76|<0.001
72463000|NCT00043186|144448696|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.78|||<|0.001||95.0|2.19|5.36|||ANCOVA|||||5.36|2.19|<0.001
72463001|NCT00043186|144448696|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.41||||0.07||95.0|-0.12|2.94|||ANCOVA|||||2.94|-0.12|0.07
72463002|NCT00043186|144448696|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.17|||<|0.001||95.0|5.54|8.8|||ANCOVA|||||8.80|5.54|<0.001
72463003|NCT00043186|144448696|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.67|||<|0.001||95.0|7.13|10.21|||ANCOVA|||||10.21|7.13|<0.001
72502035|NCT02886715|144534026|SUPERIORITY||Mean Difference (Final Values)|-4.39||||0.0354|TWO_SIDED|95.0|-8.48|-0.3|||ANOVA|with treatment and site as fixed effects in the model||||-0.30|-8.48|0.0354
72563788|NCT04100096|144658996|SUPERIORITY||LS Mean Difference|-0.11||||0.505|TWO_SIDED|95.0|-0.44|0.22||Derived from an MMRM with fixed effects of treatment, (pooled) trial site, visit, ADT status (with/without background ADT), treatment BVI, gender BVI, covariates of baseline BVI and age BVI.|MMRM||Derived from an MMRM with fixed effects of treatment, (pooled) trial site, visit, ADT status (with/without background ADT), treatment BVI, gender BVI, covariates of baseline BVI and age BVI.|Week 10||0.22|-0.44|0.5050
72463004|NCT00043186|144448696|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.15|||<|0.001||95.0|5.62|8.69|||ANCOVA|||||8.69|5.62|<0.001
72463005|NCT00043186|144448696|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.61||||0.07||95.0|-0.12|3.35|||ANCOVA|||||3.35|-0.12|0.07
72463006|NCT00043186|144448696|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.26|||<|0.001||95.0|5.56|8.95|||ANCOVA|||||8.95|5.56|<0.001
72463007|NCT00043186|144448696|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.63|||<|0.001||95.0|6.02|9.24|||ANCOVA|||||9.24|6.02|<0.001
72502036|NCT01073943|144534075|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was demonstrated if the 1-sided 97.5% CI for the treatment difference (PICOPREP minus HalfLytely) was \>-9% for the percentage of responders. Superiority was demonstrated if the 1-sided 97.5% CI for treatment difference was \>0%.|Mean Difference (Net)|3.3|||||ONE_SIDED|97.5|-2.9||||||||||-2.9|
72563789|NCT04100096|144658996|SUPERIORITY||LS Mean Difference|-0.14||||0.4277|TWO_SIDED|95.0|-0.48|0.21||Derived from an MMRM with fixed effects of treatment, (pooled) trial site, visit, ADT status (with/without background ADT), treatment BVI, gender BVI, covariates of baseline BVI and age BVI.|MMRM||Derived from an MMRM with fixed effects of treatment, (pooled) trial site, visit, ADT status (with/without background ADT), treatment BVI, gender BVI, covariates of baseline BVI and age BVI.|Week 12||0.21|-0.48|0.4277
72463008|NCT00043186|144448697|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.94||||0.002||95.0|1.86|8.02|||ANCOVA|||||8.02|1.86|0.002
72463009|NCT00043186|144448697|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.71||||0.677||95.0|-4.1|2.68|||ANCOVA|||||2.68|-4.10|0.677
72463010|NCT00043186|144448697|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.66||||0.001||95.0|3.14|10.18|||ANCOVA|||||10.18|3.14|0.001
72463011|NCT00043186|144448697|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.29|||<|0.001||95.0|5.26|11.33|||ANCOVA|||||11.33|5.26|<0.001
72463012|NCT00043186|144448697|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.5|||<|0.001||95.0|3.59|9.41|||ANCOVA|||||9.41|3.59|<0.001
72463013|NCT00043186|144448697|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.33||||0.047||95.0|0.61|8.05|||ANCOVA|||||8.05|0.61|0.047
72463014|NCT00043186|144448697|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.94||||0.003||95.0|2.53|9.36|||ANCOVA|||||9.36|2.53|0.003
72463015|NCT00043186|144448697|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.97||||0.001||95.0|3.28|10.66|||ANCOVA|||||10.66|3.28|0.001
72463016|NCT00043186|144448698|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.69|||<|0.001||95.0|2.97|6.41|||ANCOVA|||||6.41|2.97|<0.001
72463017|NCT00043186|144448698|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.16||||0.015||95.0|0.43|3.89|||ANCOVA|||||3.89|0.43|0.015
72463018|NCT00043186|144448698|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.52|||<|0.001||95.0|6.74|10.3|||ANCOVA|||||10.30|6.74|<0.001
72463019|NCT00043186|144448698|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.58|||<|0.001||95.0|7.95|11.21|||ANCOVA|||||11.21|7.95|<0.001
72463020|NCT00043186|144448698|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.34|||<|0.001||95.0|6.7|9.99|||ANCOVA|||||9.99|6.70|<0.001
72463021|NCT00043186|144448698|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.38|||<|0.001||95.0|5.45|9.31|||ANCOVA|||||9.31|5.45|<0.001
72463022|NCT00043186|144448698|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.55|||<|0.001||95.0|5.72|9.38|||ANCOVA|||||9.38|5.72|<0.001
72463023|NCT00043186|144448698|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.97|||<|0.001||95.0|7.23|10.72|||ANCOVA|||||10.72|7.23|<0.001
72463024|NCT00043186|144448699|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.44||||0.033||95.0|0.11|2.76|||ANCOVA|||||2.76|0.11|0.033
72463025|NCT00043186|144448699|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.06|||<|0.001||95.0|1.69|4.42|||ANCOVA|||||4.42|1.69|<0.001
72463026|NCT00043186|144448699|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.04|||<|0.001||95.0|1.68|4.4|||ANCOVA|||||4.40|1.68|<0.001
72463027|NCT00043186|144448699|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.26|||<|0.001||95.0|1.94|4.57|||ANCOVA|||||4.57|1.94|<0.001
72463028|NCT00043186|144448699|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.91|||<|0.001||95.0|1.6|4.21|||ANCOVA|||||4.21|1.60|<0.001
72463029|NCT00043186|144448699|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.07|||<|0.001||95.0|1.65|4.49|||ANCOVA|||||4.49|1.65|<0.001
72463030|NCT00043186|144448699|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.37|||<|0.001||95.0|0.99|3.76|||ANCOVA|||||3.76|0.99|<0.001
72463031|NCT00043186|144448699|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.86|||<|0.001||95.0|1.47|4.24|||ANCOVA|||||4.24|1.47|<0.001
72463032|NCT00043186|144448700|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.99||||0.009||95.0|0.49|3.49|||ANCOVA|||||3.49|0.49|0.009
72463033|NCT00043186|144448700|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.58|||<|0.001||95.0|2.06|5.1|||ANCOVA|||||5.10|2.06|<0.001
72463034|NCT00043186|144448700|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.26|||<|0.001||95.0|2.73|5.78|||ANCOVA|||||5.78|2.73|<0.001
72463035|NCT00043186|144448700|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.09|||<|0.001||95.0|2.55|5.62|||ANCOVA|||||5.62|2.55|<0.001
72463036|NCT00043186|144448700|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.67|||<|0.001||95.0|3.23|6.11|||ANCOVA|||||6.11|3.23|<0.001
72463037|NCT00043186|144448700|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.26|||<|0.001||95.0|3.78|6.73|||ANCOVA|||||6.73|3.78|<0.001
72463038|NCT00043186|144448700|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.08|||<|0.001||95.0|2.48|5.68|||ANCOVA|||||5.68|2.48|<0.001
72463039|NCT00043186|144448700|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.39|||<|0.001||95.0|1.86|4.93|||ANCOVA|||||4.93|1.86|<0.001
72463040|NCT00043186|144448701|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.69||||0.002||95.0|1.01|4.38|||ANCOVA|||||4.38|1.01|0.002
72463041|NCT00043186|144448701|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.77|||<|0.001||95.0|2.14|5.39|||ANCOVA|||||5.39|2.14|<0.001
72463042|NCT00043186|144448701|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.56|||<|0.001||95.0|3.87|7.26|||ANCOVA|||||7.26|3.87|<0.001
72463043|NCT00043186|144448701|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.33|||<|0.001||95.0|4.75|7.92|||ANCOVA|||||7.92|4.75|<0.001
72463044|NCT00043186|144448701|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.73|||<|0.001||95.0|4.12|7.33|||ANCOVA|||||7.33|4.12|<0.001
72463045|NCT00043186|144448701|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.7|||<|0.001||95.0|2.89|6.5|||ANCOVA|||||6.50|2.89|<0.001
72463046|NCT00043186|144448701|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.7|||<|0.001||95.0|2.92|6.49|||ANCOVA|||||6.49|2.92|<0.001
72463047|NCT00043186|144448701|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.63|||<|0.001||95.0|3.96|7.3|||ANCOVA|||||7.30|3.96|<0.001
72463048|NCT00043186|144448702|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.27||||0.496||95.0|-7.16|13.7|||ANCOVA|||||13.7|-7.16|0.496
72463049|NCT00043186|144448702|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.6||||0.527||95.0|-6.38|19.59|||ANCOVA|||||19.59|-6.38|0.527
72463050|NCT00043186|144448702|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.72||||0.503||95.0|-2.9|14.33|||ANCOVA|||||14.33|-2.90|0.503
72463051|NCT00043186|144448702|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.68||||0.527||95.0|-6.54|11.89|||ANCOVA|||||11.89|-6.54|0.527
72463052|NCT00043186|144448702|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.41||||0.503||95.0|-2.19|17.01|||ANCOVA|||||17.01|-2.19|0.503
72463053|NCT00043186|144448702|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.59||||0.503||95.0|-1.85|17.03|||ANCOVA|||||17.03|-1.85|0.503
72463054|NCT00043186|144448702|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.18||||0.503||95.0|-2.45|16.81|||ANCOVA|||||16.81|-2.45|0.503
72463055|NCT00043186|144448702|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.88||||0.233||95.0|0.78|14.97|||ANCOVA|||||14.97|0.78|0.233
72463056|NCT00043186|144448703|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.41|||<|0.001||95.0|4.48|8.34|||ANCOVA|||||8.34|4.48|<0.001
72463057|NCT00043186|144448703|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.44|||<|0.001||95.0|4.19|8.7|||ANCOVA|||||8.70|4.19|<0.001
72463058|NCT00043186|144448703|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.09|||<|0.001||95.0|3.91|8.26|||ANCOVA|||||8.26|3.91|<0.001
72463059|NCT00043186|144448703|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.72|||<|0.001||95.0|3.7|7.73|||ANCOVA|||||7.73|3.70|<0.001
72463060|NCT00043186|144448703|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.0||||0.054||95.0|-0.04|4.04|||ANCOVA|||||4.04|-0.04|0.054
72463061|NCT00043186|144448703|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.74|||<|0.001||95.0|1.71|5.77|||ANCOVA|||||5.77|1.71|<0.001
72463062|NCT00043186|144448703|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.05|||<|0.001||95.0|4.0|8.1|||ANCOVA|||||8.10|4.00|<0.001
72463063|NCT00043186|144448703|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.39|||<|0.001||95.0|4.49|8.28|||ANCOVA|||||8.28|4.49|<0.001
72463064|NCT00043186|144448704|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.3||||0.001||95.0|1.09|3.51|||ANCOVA|||||3.51|1.09|0.001
72463065|NCT00043186|144448704|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.73||||0.005||95.0|0.52|2.93|||ANCOVA|||||2.93|0.52|0.005
72463066|NCT00043186|144448704|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.0||||0.004||95.0|0.74|3.25|||ANCOVA|||||3.25|0.74|0.004
72463067|NCT00043186|144448704|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.72|||<|0.001||95.0|1.54|3.91|||ANCOVA|||||3.91|1.54|<0.001
72393232|NCT02899988|144294160|SUPERIORITY||Risk Difference (RD)|31.4||||0.007|TWO_SIDED|95.0|18.6|44.1|||Regression, Logistic|||sPGA (0)||44.1|18.6|0.007
72502037|NCT01073943|144534076|NON_INFERIORITY_OR_EQUIVALENCE|If the lower bound of the 97.5% confidence interval exceeds -9.0% then PicoPrep will be declared non-inferior to HalfLytely. If the non-inferiority test is satisfied then a test for superiority will be performed by comparing the lower bound of the 97.5% confidence interval with 0.0%. If the lower bound of the confidence interval is above 0.0% then superiority will be declared.|Mean Difference (Net)|-2.7|||||ONE_SIDED|97.5|-8.8||||||||||-8.8|
72393233|NCT02899988|144294160|SUPERIORITY||Risk Difference (RD)|31.4||||0.008|TWO_SIDED|95.0|18.6|44.1|||Regression, Logistic|||sPGA (0)||44.1|18.6|0.008
72393234|NCT02899988|144294160|SUPERIORITY||Risk Difference (RD)|35.3|||<|0.001|TWO_SIDED|95.0|21.5|49.1|||Regression, Logistic|||sPGA (0/1)||49.1|21.5|<0.001
72393235|NCT02899988|144294160|SUPERIORITY||Risk Difference (RD)|68.7|||<|0.001|TWO_SIDED|95.0|55.6|81.7|||Regression, Logistic|||sPGA (0/1)||81.7|55.6|<0.001
72393236|NCT02899988|144294160|SUPERIORITY||Risk Difference (RD)|66.7|||<|0.001|TWO_SIDED|95.0|53.4|80.0|||Regression, Logistic|||sPGA (0/1)||80.0|53.4|<0.001
72393237|NCT02899988|144294161|SUPERIORITY||Mean Difference (Net)|-26.84|STANDARD_ERROR_OF_MEAN|3.26|<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
72393238|NCT02899988|144294161|SUPERIORITY||Mean Difference (Net)|-37.99|STANDARD_ERROR_OF_MEAN|3.29|<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
72393239|NCT02899988|144294161|SUPERIORITY||Mean Difference (Net)|-29.32|STANDARD_ERROR_OF_MEAN|3.22|<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
72393240|NCT02899988|144294162|SUPERIORITY||Mean Difference (Net)|1.9|STANDARD_ERROR_OF_MEAN|0.22|<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
72393241|NCT02899988|144294162|SUPERIORITY||Mean Difference (Net)|2.56|STANDARD_ERROR_OF_MEAN|0.22|<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
72393242|NCT02899988|144294162|SUPERIORITY||Mean Difference (Net)|2.47|STANDARD_ERROR_OF_MEAN|0.22|<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
72393243|NCT02899988|144294163|SUPERIORITY||Mean Difference (Net)|-8.12|STANDARD_ERROR_OF_MEAN|0.98|<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
72393244|NCT02899988|144294163|SUPERIORITY||Mean Difference (Net)|-9.11|STANDARD_ERROR_OF_MEAN|0.97|<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
72393245|NCT02899988|144294163|SUPERIORITY||Mean Difference (Net)|-8.57|STANDARD_ERROR_OF_MEAN|0.98|<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
72393246|NCT02899988|144294164|SUPERIORITY||Mean Difference (Net)|2.11|STANDARD_ERROR_OF_MEAN|1.24||0.009|TWO_SIDED||||||ANCOVA|||Mental Component Summary (MCS)||||0.009
72393247|NCT02899988|144294164|SUPERIORITY||Mean Difference (Net)|2.74|STANDARD_ERROR_OF_MEAN|1.22||0.002|TWO_SIDED||||||ANCOVA|||Mental Component Summary (MCS)||||0.002
72393248|NCT02899988|144294164|SUPERIORITY||Mean Difference (Net)|1.52|STANDARD_ERROR_OF_MEAN|1.24||0.087|TWO_SIDED||||||ANCOVA|||Mental Component Summary (MCS)||||0.087
72502038|NCT01073943|144534077|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.0001
72502039|NCT01073943|144534078|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Fisher Exact|||||||<0.0001
72502040|NCT01073943|144534079|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.0001
72393249|NCT02899988|144294164|SUPERIORITY||Mean Difference (Net)|3.35|STANDARD_ERROR_OF_MEAN|1.2|<|0.001|TWO_SIDED||||||ANCOVA|||Physical Component Summary||||<0.001
72393250|NCT02899988|144294164|SUPERIORITY||Mean Difference (Net)|3.16|STANDARD_ERROR_OF_MEAN|1.18|<|0.001|TWO_SIDED||||||ANCOVA|||Physical Component Summary||||<0.001
72393251|NCT02899988|144294164|SUPERIORITY||Mean Difference (Net)|3.86|STANDARD_ERROR_OF_MEAN|1.19|<|0.001|TWO_SIDED||||||ANCOVA|||Physical Component Summary||||<0.001
72393252|NCT03975790|144294179|SUPERIORITY|||||||0.4695|||||||Chi-squared|||||||0.4695
72393253|NCT03975790|144294179|SUPERIORITY|||||||0.7644|||||||Chi-squared|||||||0.7644
72393254|NCT03975790|144294179|SUPERIORITY|||||||0.8316|||||||Chi-squared|||||||0.8316
72393255|NCT03975790|144294180|SUPERIORITY|||||||0.9829|||||||Chi-squared|||||||0.9829
72393256|NCT03975790|144294180|SUPERIORITY|||||||0.8021|||||||Chi-squared|||||||0.8021
72393257|NCT03975790|144294180|SUPERIORITY|||||||0.8376|||||||Chi-squared|||||||0.8376
72393258|NCT03975790|144294181|SUPERIORITY|||||||0.2864|||||||t-test|||||||0.2864
72393259|NCT03975790|144294181|SUPERIORITY|||||||0.1583|||||||t-test|||||||0.1583
72393260|NCT03975790|144294181|SUPERIORITY|||||||0.4546|||||||t-test|||||||0.4546
72393261|NCT03975790|144294182|SUPERIORITY|||||||0.028|||||||t-test|||||||0.0280
72393262|NCT03975790|144294182|SUPERIORITY|||||||0.0106|||||||t-test|||||||0.0106
72393263|NCT03975790|144294182|SUPERIORITY|||||||0.7293|||||||t-test|||||||0.7293
72393264|NCT03975790|144294183|SUPERIORITY|||||||0.9215|||||||Chi-squared|||||||0.9215
72393265|NCT03975790|144294183|SUPERIORITY|||||||0.6078|||||||Chi-squared|||||||0.6078
72393266|NCT03975790|144294183|SUPERIORITY|||||||0.6258|||||||Chi-squared|||||||0.6258
72393267|NCT03975790|144294184|SUPERIORITY|||||||0.3586|||||||Chi-squared|||||||0.3586
72393268|NCT03975790|144294184|SUPERIORITY|||||||0.5117|||||||Chi-squared|||||||0.5117
72393269|NCT03975790|144294185|SUPERIORITY|||||||0.5372|||||||t-test|||||||0.5372
72393270|NCT03975790|144294185|SUPERIORITY|||||||0.6155|||||||t-test|||||||0.6155
72393271|NCT03975790|144294185|SUPERIORITY|||||||0.9696|||||||t-test|||||||0.9696
72393272|NCT03975790|144294186|SUPERIORITY|||||||0.2514|||||||t-test|||||||0.2514
72393273|NCT03975790|144294186|SUPERIORITY|||||||0.9851|||||||t-test|||||||0.9851
72393274|NCT03975790|144294186|SUPERIORITY|||||||0.4309|||||||t-test|||||||0.4309
72393275|NCT03975790|144294187|SUPERIORITY|||||||0.6033|||||||t-test|||||||0.6033
72393276|NCT03975790|144294187|SUPERIORITY|||||||0.348|||||||t-test|||||||0.3480
72393277|NCT03975790|144294187|SUPERIORITY|||||||0.5375|||||||t-test|||||||0.5375
72393278|NCT03975790|144294188|SUPERIORITY|||||||0.0345|||||||Chi-squared|||Other aftercare||||0.0345
72393279|NCT03975790|144294188|SUPERIORITY|||||||0.2316|||||||Chi-squared|||Other aftercare||||0.2316
72393280|NCT03975790|144294188|SUPERIORITY|||||||0.7349|||||||Chi-squared|||Other aftercare||||0.7349
72393281|NCT03975790|144294188|SUPERIORITY|||||||0.0774|||||||Chi-squared|||Other connective tissue disease||||0.0774
72621150|NCT02732145|144773181|SUPERIORITY|Question: Is there a difference in the incidence of vulvar sticking versus paper-cuts pain in the patients with vulvar dermatosis who had sharp pain?||||||0.0143|||||||t-test proportion|||Parameter: The difference in the incidence of vulvar sticking versus paper-cuts pain in patients with vulvar dermatosis who had sharp vulvar pain.||||0.0143
72621151|NCT02732145|144773181|SUPERIORITY|Question: Is there a difference in the incidence of vulvar sticking versus stabbing in the patients with vulvar dermatosis who had sharp pain?||||||0.2059|||||||t-test proportion|||Parameter: The difference in the incidence of vulvar sticking versus stabbing in patients with vulvar dermatosis who had sharp vulvar pain.||||0.2059
72621152|NCT02732145|144773181|SUPERIORITY|Question: Is there a difference in the incidence of vulvar stabbing versus knife-like pain in the patients with vulvar dermatosis who had sharp pain?||||||0.682|||||||t-test proportion|||Parameter: The difference in the incidence of vulvar stabbing versus knife-like pain in patients with vulvar dermatosis who had sharp vulvar pain.||||0.6820
72621153|NCT02732145|144773181|SUPERIORITY|Question: Is there a difference in the incidence of vulvar stabbing versus paper-cuts pain in the patients with vulvar dermatosis who had sharp pain?||||||0.2059|||||||t-test proportion|||Parameter: The difference in the incidence of vulvar stabbing versus paper-cuts pain in patients with vulvar dermatosis who had sharp vulvar pain.||||0.2059
72463068|NCT00043186|144448704|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.77||||0.202||95.0|-0.41|1.95|||ANCOVA|||||1.95|-0.41|0.202
72463069|NCT00043186|144448704|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.95|||<|0.001||95.0|1.65|4.26|||ANCOVA|||||4.26|1.65|<0.001
72463070|NCT00043186|144448704|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.02||||0.004||95.0|0.78|3.26|||ANCOVA|||||3.26|0.78|0.004
72463071|NCT00043186|144448704|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.03||||0.004||95.0|0.8|3.27|||ANCOVA|||||3.27|0.80|0.004
72463072|NCT00043186|144448705|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.14|||<|0.001||95.0|1.71|4.56|||ANCOVA|||||4.56|1.71|<0.001
72463073|NCT00043186|144448705|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.4|||<|0.001||95.0|2.95|5.84|||ANCOVA|||||5.84|2.95|<0.001
72463074|NCT00043186|144448705|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.64|||<|0.001||95.0|3.19|6.09|||ANCOVA|||||6.09|3.19|<0.001
72463075|NCT00043186|144448705|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.22|||<|0.001||95.0|2.85|5.58|||ANCOVA|||||5.58|2.85|<0.001
72463076|NCT00043186|144448705|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.53|||<|0.001||95.0|1.13|3.94|||ANCOVA|||||3.94|1.13|<0.001
72502041|NCT01073943|144534080|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.0001
72621154|NCT02732145|144773181|SUPERIORITY|Question: Is there a difference in the incidence of vulvar stinging versus burning in the patients with vulvodynia?||||||0|||||||t-test proportion|||Parameter: The difference in the incidence of vulvar stinging versus burning in patients with vulvodynia.||||0.0000
72621155|NCT02732145|144773181|SUPERIORITY|Question: Is there a difference in the incidence of vulvar stinging versus soreness in the patients with vulvodynia?||||||0.0344|||||||t-test proportion|||Parameter: The difference in the incidence of vulvar stinging versus soreness in patients with vulvodynia.||||0.0344
72621156|NCT02732145|144773181|SUPERIORITY|Question: Is there a difference in the incidence of vulvar stinging versus irritation in the patients with vulvodynia?||||||0.0023|||||||t-test proportion|||Parameter: The difference in the incidence of vulvar stinging versus irritation in patients with vulvodynia.||||0.0023
72621157|NCT02732145|144773181|SUPERIORITY|Question: Is there a difference in the incidence of vulvar stinging versus itching in the patients with vulvodynia?||||||0.5675|||||||t-test proportion|||Parameter: The difference in the incidence of vulvar stinging versus itching in patients with vulvodynia.||||0.5675
72463077|NCT00043186|144448705|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.09|||<|0.001||95.0|4.53|7.64|||ANCOVA|||||7.64|4.53|<0.001
72463078|NCT00043186|144448705|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.55|||<|0.001||95.0|3.12|5.98|||ANCOVA|||||5.98|3.12|<0.001
72463079|NCT00043186|144448705|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.23|||<|0.001||95.0|2.76|5.69|||ANCOVA|||||5.69|2.76|<0.001
72463080|NCT00043186|144448706|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.16|||<|0.001||95.0|3.63|8.68|||ANCOVA|||||8.68|3.63|<0.001
72463081|NCT00043186|144448706|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.32||||0.275||95.0|-1.06|3.7|||ANCOVA|||||3.7|-1.06|0.275
72463082|NCT00043186|144448706|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.2||||0.005||95.0|1.65|6.75|||ANCOVA|||||6.75|1.65|0.005
72463083|NCT00043186|144448706|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.41||||0.002||95.0|2.07|6.75|||ANCOVA|||||6.75|2.07|0.002
72463084|NCT00043186|144448706|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.65||||0.009||95.0|1.25|6.05|||ANCOVA|||||6.05|1.25|0.009
72463085|NCT00043186|144448706|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.95||||0.009||95.0|1.22|6.68|||ANCOVA|||||6.68|1.22|0.009
72463086|NCT00043186|144448706|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.65||||0.003||95.0|2.05|7.24|||ANCOVA|||||7.24|2.05|0.003
72463087|NCT00043186|144448706|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.75||||0.001||95.0|2.28|7.22|||ANCOVA|||||7.22|2.28|0.001
72463088|NCT00043186|144448707|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.18||||0.949||95.0|-8.73|13.1|||ANCOVA|||||13.10|-8.73|0.949
72463089|NCT00043186|144448707|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.3||||0.949||95.0|-2.7|9.31|||ANCOVA|||||9.31|-2.70|0.949
72463090|NCT00043186|144448707|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.24||||0.709||95.0|-6.81|9.29|||ANCOVA|||||9.29|-6.81|0.709
72463091|NCT00043186|144448707|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.36||||0.949||95.0|-8.55|3.83|||ANCOVA|||||3.83|-8.55|0.949
72463092|NCT00043186|144448707|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.1||||0.949||95.0|-4.51|8.72|||ANCOVA|||||8.72|-4.51|0.949
72463093|NCT00043186|144448707|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.23||||0.484||95.0|-0.83|15.3|||ANCOVA|||||15.3|-0.83|0.484
72463094|NCT00043186|144448707|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.44||||0.949||95.0|-3.77|8.66|||ANCOVA|||||8.66|-3.77|0.949
72463095|NCT00043186|144448707|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.29||||0.949||95.0|-10.82|11.4|||ANCOVA|||||11.40|-10.82|0.949
72502042|NCT01073943|144534081|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Fisher Exact|||||||<0.0001
72463096|NCT00043186|144448708|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.02|||<|0.001||95.0|4.35|9.69|||ANCOVA|||||9.69|4.35|<0.001
72621158|NCT02732145|144773181|SUPERIORITY|Question: Is there a difference in the incidence of vulvar stinging versus the feeling of inflammation in the patients with vulvodynia?||||||0.0037|||||||t-test proportion|||Parameter: The difference in the incidence of vulvar stinging versus the feeling of inflammation in patients with vulvodynia.||||0.0037
72393282|NCT03975790|144294188|SUPERIORITY|||||||0.4228|||||||Chi-squared|||Other connective tissue disease||||0.4228
72463097|NCT00043186|144448708|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.25||||0.092||95.0|-0.37|4.87|||ANCOVA|||||4.87|-0.37|0.092
72463098|NCT00043186|144448708|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.22|||<|0.001||95.0|3.5|8.94|||ANCOVA|||||8.94|3.50|<0.001
72463099|NCT00043186|144448708|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.97|||<|0.001||95.0|3.51|8.43|||ANCOVA|||||8.43|3.51|<0.001
72463100|NCT00043186|144448708|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.96|||<|0.001||95.0|3.44|8.48|||ANCOVA|||||8.48|3.44|<0.001
72463101|NCT00043186|144448708|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.29|||<|0.001||95.0|3.25|9.34|||ANCOVA|||||9.34|3.25|<0.001
72463102|NCT00043186|144448708|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.91|||<|0.001||95.0|3.13|8.7|||ANCOVA|||||8.70|3.13|<0.001
72502043|NCT01073943|144534082|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Fisher Exact|||||||<0.0001
72463103|NCT00043186|144448708|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.22|||<|0.001||95.0|3.58|8.87|||ANCOVA|||||8.87|3.58|<0.001
72463104|NCT00043186|144448709|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
72563790|NCT04100096|144658997|SUPERIORITY||Mean Difference (Final Values)|0.06||||0.6225|TWO_SIDED|95.0|-0.18|0.3||Comparison between TGs was carried out using the Cochran-Mantel-Haenszel (CMH) Row Mean Score Differ Test controlling for trial site.|Cochran-Mantel-Haenszel||Comparison between TGs was carried out using the CMH Row Mean Score Differ Test controlling for trial site.|Week 2||0.30|-0.18|0.6225
72463105|NCT00043186|144448709|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
72463106|NCT00043186|144448709|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
72502044|NCT01073943|144534084|NON_INFERIORITY_OR_EQUIVALENCE|If the lower bound of the 97.5% confidence interval exceeds -9.0% then PicoPrep will be declared non-inferior to HalfLytely. If the non-inferiority test is satisfied then a test for superiority will be performed by comparing the lower bound of the 97.5% confidence interval with 0.0%. If the lower bound of the confidence interval is above 0.0% then superiority will be declared.|Mean Difference (Net)|4.5|||||ONE_SIDED|97.5|-0.1|||||||Mid colon comparison|||-0.1|
72563791|NCT04100096|144658997|SUPERIORITY||Mean Difference (Final Values)|-0.02||||0.9145|TWO_SIDED|95.0|-0.35|0.31||Comparison between TGs was carried out using the CMH Row Mean Score Differ Test controlling for trial site.|Cochran-Mantel-Haenszel||Comparison between TGs was carried out using the CMH Row Mean Score Differ Test controlling for trial site.|Week 4||0.31|-0.35|0.9145
72393283|NCT03975790|144294188|SUPERIORITY|||||||0.0583|||||||Chi-squared|||Other connective tissue disease||||0.0583
72393284|NCT03975790|144294188|SUPERIORITY|||||||0.9683|||||||Chi-squared|||Other non-traumatic joint disorders||||0.9683
72463107|NCT00043186|144448709|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
72463108|NCT00043186|144448709|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
72463109|NCT00043186|144448709|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
72463110|NCT00043186|144448709|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
72463111|NCT00043186|144448709|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
72463112|NCT00043186|144448710|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
72463113|NCT00043186|144448710|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
72463114|NCT00043186|144448710|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
72463115|NCT00043186|144448710|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
72463116|NCT00043186|144448710|SUPERIORITY_OR_OTHER|||||||0.002|||||||Wilcoxon (Mann-Whitney)|||||||0.002
72463117|NCT00043186|144448710|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
72463118|NCT00043186|144448710|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
72463119|NCT00043186|144448710|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
72463120|NCT00043186|144448711|SUPERIORITY_OR_OTHER|||||||0.049|||||||Wilcoxon (Mann-Whitney)|||||||0.049
72463121|NCT00043186|144448711|SUPERIORITY_OR_OTHER|||||||0.008|||||||Wilcoxon (Mann-Whitney)|||||||0.008
72463122|NCT00043186|144448711|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
72463123|NCT00043186|144448711|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
72463124|NCT00043186|144448711|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
72463125|NCT00043186|144448711|SUPERIORITY_OR_OTHER|||||||0.146|||||||Wilcoxon (Mann-Whitney)|||||||0.146
72463126|NCT00043186|144448711|SUPERIORITY_OR_OTHER|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||||||0.001
72463127|NCT00043186|144448711|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
72463128|NCT00043186|144448712|SUPERIORITY_OR_OTHER|||||||0.061|||||||Wilcoxon (Mann-Whitney)|||||||0.061
72463129|NCT00043186|144448712|SUPERIORITY_OR_OTHER|||||||0.058|||||||Wilcoxon (Mann-Whitney)|||||||0.058
72463130|NCT00043186|144448712|SUPERIORITY_OR_OTHER|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||||||0.001
72463131|NCT00043186|144448712|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
72463132|NCT00043186|144448712|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
72463133|NCT00043186|144448712|SUPERIORITY_OR_OTHER|||||||0.003|||||||Wilcoxon (Mann-Whitney)|||||||0.003
72463134|NCT00043186|144448712|SUPERIORITY_OR_OTHER|||||||0.003|||||||Wilcoxon (Mann-Whitney)|||||||0.003
72463135|NCT00043186|144448712|SUPERIORITY_OR_OTHER|||||||0.002|||||||Wilcoxon (Mann-Whitney)|||||||0.002
72463136|NCT00043186|144448713|SUPERIORITY_OR_OTHER|||||||0.142|||||||Wilcoxon (Mann-Whitney)|||||||0.142
72463137|NCT00043186|144448713|SUPERIORITY_OR_OTHER|||||||0.218|||||||Wilcoxon (Mann-Whitney)|||||||0.218
72463138|NCT00043186|144448713|SUPERIORITY_OR_OTHER|||||||0.003|||||||Wilcoxon (Mann-Whitney)|||||||0.003
72463139|NCT00043186|144448713|SUPERIORITY_OR_OTHER|||||||0.01|||||||Wilcoxon (Mann-Whitney)|||||||0.010
72463140|NCT00043186|144448713|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
72463141|NCT00043186|144448713|SUPERIORITY_OR_OTHER|||||||0.01|||||||Wilcoxon (Mann-Whitney)|||||||0.010
72463142|NCT00043186|144448713|SUPERIORITY_OR_OTHER|||||||0.02|||||||Wilcoxon (Mann-Whitney)|||||||0.020
72463143|NCT00043186|144448713|SUPERIORITY_OR_OTHER|||||||0.02|||||||Wilcoxon (Mann-Whitney)|||||||0.020
72463144|NCT05012280|144448715|SUPERIORITY||Odds Ratio (OR)|1.221||||0.115|TWO_SIDED|95.0|0.953|1.564||only one primary endpoint, p value not adjusted for multiple comparisons. A priori treshold or statistical significance: p=0.05|Regression, Logistic|conditional logistic regression for matched case control||||1.564|0.953|0.1150
72463145|NCT05012280|144448715|SUPERIORITY||Odds Ratio (OR)|1.221||||0.12|TWO_SIDED|95.0|0.953|1.564|||Regression, Logistic|conditional logistic regression for matched case control study.||||1.564|0.953|0.12
72463146|NCT02229396|144448716|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.38|STANDARD_ERROR_OF_MEAN|0.129||0.003|TWO_SIDED|95.0|-0.63|-0.13|||Mixed Models Analysis|Treatment, region, baseline HbA1c stratum (\<9.0% or ≥9.0%), week, and treatment by week interaction as fixed factors; baseline value as covariate.||||-0.13|-0.63|0.003
72502045|NCT01073943|144534084|NON_INFERIORITY_OR_EQUIVALENCE|If the lower bound of the 97.5% confidence interval exceeds -9.0% then PicoPrep will be declared non-inferior to HalfLytely. If the non-inferiority test is satisfied then a test for superiority will be performed by comparing the lower bound of the 97.5% confidence interval with 0.0%. If the lower bound of the confidence interval is above 0.0% then superiority will be declared.|Mean Difference (Net)|3.2|||||ONE_SIDED|97.5|-1.5|||||||Recto-sigmoid colon comparison|||-1.5|
72563792|NCT04100096|144658997|SUPERIORITY||Mean Difference (Final Values)|-0.22||||0.1535|TWO_SIDED|95.0|-0.52|0.08||Comparison between TGs was carried out using the CMH Row Mean Score Differ Test controlling for trial site.|Cochran-Mantel-Haenszel||Comparison between TGs was carried out using the CMH Row Mean Score Differ Test controlling for trial site.|Week 6||0.08|-0.52|0.1535
72563793|NCT04100096|144658997|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.1922|TWO_SIDED|95.0|-0.5|0.1||Comparison between TGs was carried out using the CMH Row Mean Score Differ Test controlling for trial site.|Cochran-Mantel-Haenszel||Comparison between TGs was carried out using the CMH Row Mean Score Differ Test controlling for trial site.|Week 8||0.10|-0.50|0.1922
72563794|NCT04100096|144658997|SUPERIORITY||Mean Difference (Final Values)|-0.08||||0.6488|TWO_SIDED|95.0|-0.4|0.25||Comparison between TGs was carried out using the CMH Row Mean Score Differ Test controlling for trial site.|Cochran-Mantel-Haenszel||Comparison between TGs was carried out using the CMH Row Mean Score Differ Test controlling for trial site.|Week 10||0.25|-0.40|0.6488
72563795|NCT04100096|144658997|SUPERIORITY||Mean Difference (Final Values)|-0.08||||0.5992|TWO_SIDED|95.0|-0.4|0.23||Comparison between TGs was carried out using the CMH Row Mean Score Differ Test controlling for trial site.|Cochran-Mantel-Haenszel||Comparison between TGs was carried out using the CMH Row Mean Score Differ Test controlling for trial site.|Week 12||0.23|-0.40|0.5992
72563796|NCT04100096|144658998|SUPERIORITY||Mean Difference (Final Values)|-0.05||||0.6579|TWO_SIDED|95.0|-0.29|0.19||Comparison between TGs was carried out using the CMH Row Mean Score Differ Test controlling for trial site.|Cochran-Mantel-Haenszel||Comparison between TGs was carried out using the CMH Row Mean Score Differ Test controlling for trial site.|Week 2||0.19|-0.29|0.6579
72393285|NCT03975790|144294188|SUPERIORITY|||||||0.8877|||||||Chi-squared|||Other non-traumatic joint disorders||||0.8877
72393286|NCT03975790|144294188|SUPERIORITY|||||||0.9228|||||||Chi-squared|||Other non-traumatic joint disorders||||0.9228
72463147|NCT02229396|144448716|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.59|STANDARD_ERROR_OF_MEAN|0.127|<|0.001|TWO_SIDED|95.0|-0.84|-0.34|||Mixed Models Analysis|Treatment, region, baseline HbA1c stratum (\<9.0% or ≥9.0%), week, and treatment by week interaction as fixed factors; baseline value as covariate.||||-0.34|-0.84|<0.001
72463148|NCT02229396|144448717|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.0|STANDARD_ERROR_OF_MEAN|0.406|<|0.001|TWO_SIDED|95.0|-2.79|-1.2|||Mixed Models Analysis|Treatment, region, baseline HbA1c stratum (\<9.0% or ≥9.0%), week, and treatment by week interaction as fixed factors; baseline value as covariate.||||-1.20|-2.79|<0.001
72463149|NCT02229396|144448717|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.33|STANDARD_ERROR_OF_MEAN|0.4|<|0.001|TWO_SIDED|95.0|-2.12|-0.55|||Mixed Models Analysis|Treatment, region, baseline HbA1c stratum (\<9.0% or ≥9.0%), week, and treatment by week interaction as fixed factors; baseline value as covariate.||||-0.55|-2.12|<0.001
72463150|NCT02229396|144448718|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-20.08|STANDARD_ERROR_OF_MEAN|4.007|<|0.001|TWO_SIDED|95.0|-27.95|-12.2|||Mixed Models Analysis|Treatment, region, baseline HbA1c stratum (\<9.0% or ≥9.0%), week, and treatment by week interaction as fixed factors; baseline value as covariate.||||-12.20|-27.95|<0.001
72463151|NCT02229396|144448718|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.64|STANDARD_ERROR_OF_MEAN|3.947|<|0.001|TWO_SIDED|95.0|-24.39|-8.89|||Mixed Models Analysis|Treatment, region, baseline HbA1c stratum (\<9.0% or ≥9.0%), week, and treatment by week interaction as fixed factors; baseline value as covariate.||||-8.89|-24.39|<0.001
72463152|NCT02229396|144448719|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-27.74|STANDARD_ERROR_OF_MEAN|5.168|<|0.001|TWO_SIDED|95.0|-37.89|-17.59|||ANCOVA|Treatment, region, and baseline HbA1c stratum (\<9.0% or ≥9.0%), as fixed factors; baseline value as covariate.||||-17.59|-37.89|<0.001
72463153|NCT02229396|144448719|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-26.78|STANDARD_ERROR_OF_MEAN|5.09|<|0.001|TWO_SIDED|95.0|-36.78|-16.78|||ANCOVA|Treatment, region, and baseline HbA1c stratum (\<9.0% or ≥9.0%), as fixed factors; baseline value as covariate.||||-16.78|-36.78|<0.001
72463154|NCT02229396|144448720|SUPERIORITY_OR_OTHER||Difference in percentages|19.7|||<|0.001|||||||Cochran-Mantel-Haenszel|Stratified by baseline HbA1c (\<9.0% or ≥9.0%).||||||<0.001
72563797|NCT04100096|144658998|SUPERIORITY||Mean Difference (Final Values)|-0.14||||0.3728|TWO_SIDED|95.0|-0.43|0.16||Comparison between TGs was carried out using the CMH Row Mean Score Differ Test controlling for trial site.|Cochran-Mantel-Haenszel||Comparison between TGs was carried out using the CMH Row Mean Score Differ Test controlling for trial site.|Week 4||0.16|-0.43|0.3728
72463155|NCT02229396|144448720|SUPERIORITY_OR_OTHER||Difference in percentages|13.3||||0.001|||||||Cochran-Mantel-Haenszel|Stratified by baseline HbA1c (\<9.0% or ≥9.0%).||||||0.001
72393287|NCT03975790|144294188|SUPERIORITY|||||||0.7661|||||||Chi-squared|||Medical examination/evaluation||||0.7661
72393288|NCT03975790|144294188|SUPERIORITY|||||||0.3034|||||||Chi-squared|||Medical examination/evaluation||||0.3034
72463156|NCT02229396|144448721|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-20.26|STANDARD_ERROR_OF_MEAN|3.494|<|0.001|TWO_SIDED|95.0|-27.12|-13.4|||Mixed Models Analysis|Treatment, region, baseline HbA1c stratum (\<9.0% or ≥9.0%), week, and treatment by week interaction as fixed factors; baseline value as covariate.||||-13.40|-27.12|<0.001
72463157|NCT02229396|144448721|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.03|STANDARD_ERROR_OF_MEAN|3.477|<|0.001|TWO_SIDED|95.0|-21.85|-8.2||This is a nominal p-value.|Mixed Models Analysis|Treatment, region, baseline HbA1c stratum (\<9.0% or ≥9.0%), week, and treatment by week interaction as fixed factors; baseline value as covariate.||||-8.20|-21.85|<0.001
72463158|NCT02229396|144448722|SUPERIORITY_OR_OTHER||Difference in percentages|17.9|||<|0.001|||||||Cochran-Mantel-Haenszel|Stratified by baseline HbA1c (\<9.0% or ≥9.0%).||||||<0.001
72463159|NCT02229396|144448722|SUPERIORITY_OR_OTHER||Difference in percentages|25.6|||<|0.001|||||||Cochran-Mantel-Haenszel|Stratified by baseline HbA1c (\<9.0% or ≥9.0%).||||||<0.001
72463160|NCT02229396|144448723|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.0|STANDARD_ERROR_OF_MEAN|1.08||0.005|TWO_SIDED|95.0|-5.2|-0.9|||Mixed Models Analysis|Treatment, region, baseline HbA1c stratum (\<9.0% or ≥9.0%), week, and treatment by week interaction as fixed factors; baseline value as covariate.||||-0.9|-5.2|0.005
72463161|NCT02229396|144448723|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.4|STANDARD_ERROR_OF_MEAN|1.06||0.022|TWO_SIDED|95.0|-4.5|-0.4|||Mixed Models Analysis|Treatment, region, baseline HbA1c stratum (\<9.0% or ≥9.0%), week, and treatment by week interaction as fixed factors; baseline value as covariate.||||-0.4|-4.5|0.022
72463162|NCT03245762|144448729|SUPERIORITY||Odds Ratio (OR)|0.9||||0.93|TWO_SIDED||||||Ordinal Categorical Analysis|||||||0.930
72463163|NCT00871143|144448760|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||An alpha level of .05 (two-sided) was set.|Mixed Models Analysis|||Linear mixed models were conducted to determine the predictive value of treatment group and/or time on the outcome variable scores.||||<.001
72502046|NCT01073943|144534084|NON_INFERIORITY_OR_EQUIVALENCE|If the lower bound of the 97.5% confidence interval exceeds -9.0% then PicoPrep will be declared non-inferior to HalfLytely. If the non-inferiority test is satisfied then a test for superiority will be performed by comparing the lower bound of the 97.5% confidence interval with 0.0%. If the lower bound of the confidence interval is above 0.0% then superiority will be declared.|Mean Difference (Net)|0.9|||||ONE_SIDED|97.5|-5.7|||||||Overall comparison: ascending colon, mid colon and recto-sigmoid colon|||-5.7|
72563798|NCT04100096|144658998|SUPERIORITY||Mean Difference (Final Values)|-0.21||||0.1684|TWO_SIDED|95.0|-0.5|0.09||Comparison between TGs was carried out using the CMH Row Mean Score Differ Test controlling for trial site.|Cochran-Mantel-Haenszel||Comparison between TGs was carried out using the CMH Row Mean Score Differ Test controlling for trial site.|Week 6||0.09|-0.50|0.1684
72563799|NCT04100096|144658998|SUPERIORITY||Mean Difference (Final Values)|-0.44||||0.0046|TWO_SIDED|95.0|-0.74|-0.13||Comparison between TGs was carried out using the CMH Row Mean Score Differ Test controlling for trial site.|Cochran-Mantel-Haenszel||Comparison between TGs was carried out using the CMH Row Mean Score Differ Test controlling for trial site.|Week 8||-0.13|-0.74|0.0046
72563800|NCT04100096|144658998|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.2087|TWO_SIDED|95.0|-0.51|0.11||Comparison between TGs was carried out using the CMH Row Mean Score Differ Test controlling for trial site.|Cochran-Mantel-Haenszel||Comparison between TGs was carried out using the CMH Row Mean Score Differ Test controlling for trial site.|Week 10||0.11|-0.51|0.2087
72463164|NCT00871143|144448760|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Bonferroni correction was used to decrease the risk of type I error.|t-test, 2 sided|||Investigating the difference in BDD YBOCS score between baseline and week 12||||<.001
72463165|NCT00871143|144448760|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Bonferroni corrections were used to reduce risk of Type 1 error.|t-test, 2 sided|||Investigating the difference in BDD YBOCS score between between baseline and 1 month follow up||||< .001
72463166|NCT00871143|144448760|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED|||||Bonferroni correction was used to decrease the risk of type I error.|t-test, 2 sided|||Investigating the difference in BDD YBOCS score between baseline and week 12||||<.01
72463167|NCT00871143|144448760|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|||||Bonferroni correction was used to decrease risk of type I error|t-test, 2 sided|||Investigating the difference in BDD YBOCS score between baseline and 1 month follow up||||< 0.05
72393289|NCT03975790|144294188|SUPERIORITY|||||||0.2765|||||||Chi-squared|||Medical examination/evaluation||||0.2765
72393290|NCT03975790|144294188|SUPERIORITY|||||||0.8652|||||||Chi-squared|||Other suspected conditions||||0.8652
72393291|NCT03975790|144294188|SUPERIORITY|||||||0.2243|||||||Chi-squared|||Other suspected conditions||||0.2243
72502047|NCT03830281|144534093|NON_INFERIORITY|Noninferiority margin = 0.4% for HbA1c|Mean Difference (Final Values)|0.02||||0.565|TWO_SIDED|95.0|-0.06|0.11|||Mixed Models Analysis|||||0.11|-0.06|0.565
72502048|NCT03830281|144534094|SUPERIORITY||LS Mean Difference|-24.1|||<|0.001|TWO_SIDED|95.0|-36.0|-12.2|||ANCOVA|||||-12.2|-36.0|<0.001
72502049|NCT03830281|144534095|SUPERIORITY||LS Mean Difference|-27.8|||<|0.001|TWO_SIDED|95.0|-42.6|-13.0|||ANCOVA|||||-13.0|-42.6|< 0.001
72393292|NCT03975790|144294188|SUPERIORITY|||||||0.3449|||||||Chi-squared|||Other suspected conditions||||0.3449
72393293|NCT03975790|144294188|SUPERIORITY|||||||0.3529|||||||Chi-squared|||Immunizations/screening for infectious disease||||0.3529
72393294|NCT03975790|144294188|SUPERIORITY|||||||0.1012|||||||Chi-squared|||Immunizations/screening for infectious disease||||0.1012
72393295|NCT03975790|144294188|SUPERIORITY|||||||0.4123|||||||Chi-squared|||Immunizations/screening for infectious disease||||0.4123
72393296|NCT03975790|144294188|SUPERIORITY|||||||0.2742|||||||Chi-squared|||Osteoarthritis||||0.2742
72463168|NCT00871143|144448761|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|||||An alpha level of .05 was set (two-sided).|Mixed Models Analysis|||Linear mixed models were conducted to determine the predictive value of treatment group and/or time on the outcome variable scores.||||<.05
72463169|NCT00871143|144448761|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED|||||Bonferroni correction was used to decrease the risk of type I error.|t-test, 2 sided|||T-tests were used to investigate significant differences between baseline and 12 week measures||||<0.01
72463170|NCT00871143|144448761|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Bonferroni corrections were implemented to adjust for type I error|t-test, 2 sided|||T-tests were used to investigate significant differences between baseline and 1 month follow up.||||< 0.001
72463171|NCT00871143|144448761|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||Bonferroni correction was used to decrease the risk of type I error.|t-test, 2 sided|||T-tests were used to investigate significant differences between baseline and 12 week assessment measures and baseline and 1 month follow up measures.||||>0.05
72463172|NCT00871143|144448761|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||Bonferroni corrections were used to reduce risk of type I error|t-test, 2 sided|||T-tests were used to investigate significant differences between baseline and 1 month follow up measures.||||>0.05
72463173|NCT00871143|144448762|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||An alpha level of .05 was set (two-sided).|Mixed Models Analysis|||A Linear mixed model was conducted to determine the predictive value of treatment group and/or time on the outcome variable MADRS scores.||||>0.05
72463174|NCT00871143|144448762|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED|||||Bonferroni correction was used to decrease the risk of type I error.|t-test, 2 sided|||Investigating the difference in MADRS score between baseline and week 12.||||<0.01
72502050|NCT03830281|144534096|SUPERIORITY||LS Mean Difference|0.7||||0.532|TWO_SIDED|95.0|-1.4|2.8|||Mixed Models Analysis|||Statistical analysis during daytime is reported.||2.8|-1.4|0.532
72502051|NCT03830281|144534096|SUPERIORITY||LS Mean Difference|0.4||||0.738|TWO_SIDED|95.0|-1.8|2.5|||Mixed Models Analysis|||Statistical analysis during 24-hour period is reported.||2.5|-1.8|0.738
72502052|NCT01299025|144534121|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<0.01
72563801|NCT04100096|144658998|SUPERIORITY||Mean Difference (Final Values)|-0.33||||0.0389|TWO_SIDED|95.0|-0.64|-0.02||Comparison between TGs was carried out using the CMH Row Mean Score Differ Test controlling for trial site.|Cochran-Mantel-Haenszel||Comparison between TGs was carried out using the CMH Row Mean Score Differ Test controlling for trial site.|Week 12||-0.02|-0.64|0.0389
72563802|NCT04100096|144659003|SUPERIORITY||Mean Difference (Final Values)|0.18||||0.272|TWO_SIDED|95.0|-0.14|0.5||ANCOVA model, with treatment as main effect and baseline value as covariate, is used for change from baseline of case comparisons.|ANCOVA|||Week 2||0.50|-0.14|0.2720
72563803|NCT04100096|144659003|SUPERIORITY||Mean Difference (Final Values)|1.09||||0|TWO_SIDED|95.0|0.63|1.56||ANCOVA model, with treatment as main effect and baseline value as covariate, is used for change from baseline of case comparisons.|ANCOVA|||Week 4||1.56|0.63|0
72563804|NCT04100096|144659003|SUPERIORITY||Mean Difference (Final Values)|1.18||||0|TWO_SIDED|95.0|0.63|1.73||ANCOVA model, with treatment as main effect and baseline value as covariate, is used for change from baseline of case comparisons|ANCOVA|||Week 6||1.73|0.63|0
72563805|NCT04100096|144659003|SUPERIORITY||Mean Difference (Final Values)|1.57||||0|TWO_SIDED|95.0|0.92|2.21||ANCOVA model, with treatment as main effect and baseline value as covariate, is used for change from baseline of case comparisons.|ANCOVA|||Week 8||2.21|0.92|0
72563806|NCT04100096|144659003|SUPERIORITY||Mean Difference (Final Values)|1.72||||0|TWO_SIDED|95.0|0.99|2.45||ANCOVA model, with treatment as main effect and baseline value as covariate, is used for change from baseline of case comparisons.|ANCOVA|||Week 10||2.45|0.99|0
72563807|NCT04100096|144659003|SUPERIORITY||Mean Difference (Final Values)|1.44||||0.0002|TWO_SIDED|95.0|0.68|2.19||ANCOVA model, with treatment as main effect and baseline value as covariate, is used for change from baseline of case comparisons.|ANCOVA|||Week 12||2.19|0.68|0.0002
72563808|NCT04100096|144659004|SUPERIORITY||Mean Difference (Final Values)|1.31||||0.062|TWO_SIDED|95.0|-0.07|2.68|||ANCOVA|ANCOVA model, with treatment as main effect and baseline value as covariate, is used for change from baseline of case comparisons.||Week 12||2.68|-0.07|0.0620
72463175|NCT00871143|144448762|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||Bonferonni corrections used to reduce risk of type I error|t-test, 2 sided|||Investigating the difference in MADRS score between baseline and 1 month follow up.||||>0.05
72463176|NCT00871143|144448762|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||Bonferroni correction was used to decrease the risk of type I error.|t-test, 2 sided|||Investigating the difference in MADRS score between baseline and week 12.||||>0.05
72463177|NCT00871143|144448762|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||Bonferroni corrections used to decrease risk of type I error|t-test, 2 sided|||Investigating the difference in MADRS score between baseline and 1 month follow up.||||> 0.05
72563809|NCT04100096|144659005|SUPERIORITY||Mean Difference (Final Values)|0.05||||0.4613|TWO_SIDED|95.0|-0.08|0.17|||ANCOVA|ANCOVA model, with treatment as main effect and baseline value as covariate, is used for change from baseline of case comparisons.||Week 2||0.17|-0.08|0.4613
72393297|NCT03975790|144294188|SUPERIORITY|||||||0.1009|||||||Chi-squared|||Osteoarthritis||||0.1009
72463178|NCT00871143|144448763|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|||||An alpha level of .05 (two-sided) was set.|Mixed Models Analysis|||Linear mixed models were conducted to determine the predictive value of treatment group and/or time on the outcome variable of AAI scores.||||<0.05
72502053|NCT05662332|144534133|NON_INFERIORITY|Noninferiority margin (NIM) was 0.4%|LS Mean Change difference|-0.03|||||TWO_SIDED|95.0|-0.18|0.12|||ANCOVA|||||0.12|-0.18|
72502054|NCT05662332|144534134|SUPERIORITY||LS Mean Change difference|-0.03||||0.684|TWO_SIDED|95.0|-0.18|0.12|||ANCOVA|||||0.12|-0.18|0.684
72502055|NCT05662332|144534135|SUPERIORITY||LS Mean Change difference|4.16||||0.155|TWO_SIDED|95.0|-1.58|9.9|||ANCOVA|||Week 52||9.90|-1.58|0.155
72502056|NCT05662332|144534136|SUPERIORITY||LS Mean Change difference|-43.7|||<|0.001|TWO_SIDED|95.0|-62.4|-25.0|||Mixed Models Analysis|||Week 52||-25.0|-62.4|<0.001
72502057|NCT05662332|144534137|SUPERIORITY||Relative Rate|0.57||||0.005|TWO_SIDED|95.0|0.39|0.84|||Negative binomial model|||||0.84|0.39|0.005
72502058|NCT05662332|144534139|SUPERIORITY||Relative Rate|0.58||||0.155|TWO_SIDED|95.0|0.28|1.23|||Negative binomial model|||||1.23|0.28|0.155
72502059|NCT05662332|144534141|SUPERIORITY||LS Mean difference (Final Values)|0.57||||0.033|TWO_SIDED|95.0|0.047|1.1|||Mixed Models Analysis|||||1.10|0.047|0.033
72502060|NCT05662332|144534142|SUPERIORITY||LS Mean difference (Final Values)|1.56||||0.071|TWO_SIDED|95.0|-0.13|3.25|||Mixed Models Analysis|||Week 52||3.25|-0.13|0.071
72502061|NCT05662332|144534145|SUPERIORITY||LS Mean difference (Final Values)|1.8||||0.072|TWO_SIDED|95.0|-0.2|3.8|||Mixed Models Analysis|||Week 52||3.8|-0.2|0.072
72502062|NCT04885257|144534147|SUPERIORITY|||||||0.896|||||||Wilcoxon (Mann-Whitney)|||||||0.896
72393298|NCT03975790|144294188|SUPERIORITY|||||||0.0318|||||||Chi-squared|||Osteoarthritis||||0.0318
72393299|NCT03975790|144294188|SUPERIORITY|||||||0.4808|||||||Chi-squared|||Essential hypertension||||0.4808
72393300|NCT03975790|144294188|SUPERIORITY|||||||0.0778|||||||Chi-squared|||Essential hypertension||||0.0778
72463179|NCT00871143|144448763|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Bonferroni corrections were applied to decrease the risk of type I error.|t-test, 2 sided|||Repeated- measures t tests were used to determine where significant differences in AAI scores occurred from baseline to 12 week .||||<0.001
72463180|NCT00871143|144448763|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Bonferroni corrections were used to reduce risk of type 1 error|t-test, 2 sided|||Repeated- measures t tests were used to determine where significant differences in AAI scores occurred from baseline to 2 month follow up.||||< 0.001
72463181|NCT00871143|144448763|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|||||Bonferroni Correction was used in an attempt to reduce risk of type I error.|t-test, 2 sided|||Repeated- measures t tests were used to determine where significant differences in AAI scores occurred from baseline to 12 week .||||<0.05
72463182|NCT00871143|144448763|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||Bonferroni corrections were used to adjust for type 1 error|t-test, 2 sided|||Repeated- measures t tests were used to determine where significant differences in AAI scores occurred from baseline to 2 month follow up.||||>0.05
72463183|NCT00871143|144448764|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||An alpha level of .05 was set (two-sided).|Mixed Models Analysis|||Linear mixed models were conducted to determine the predictive value of treatment group and/or time on the PHQ-9 score.||||>0.05
72463184|NCT00871143|144448764|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|||||Where more than 1 t test had been conducted on each variable, a Bonferroni correction was used to decrease the risk of type I error.|t-test, 2 sided|||Repeated- measures t tests were used to determine where significant differences occurred from baseline to end of treatment (12 weeks).||||<0.05
72463185|NCT00871143|144448764|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||Bonferroni corrections were used to reduce risk of type I error|t-test, 2 sided|||Repeated- measures t tests were used to determine where significant differences occurred from baseline to 2 month follow up.||||> 0.05
72502063|NCT00803114|144534151|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.22||||0.05||95.0|0.12|0.41|||Fisher Exact||Relative risk describes the risk of requiring additional analgesics in the first 24 hours postpartum with the denominator being the arm which received placebo.|Relative risk ratio estimation with 95% CI using exact methods||0.41|0.12|0.05
72463186|NCT00871143|144448764|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||A Bonferroni correction was used to decrease the risk of type I error.|t-test, 2 sided|||Repeated- measures t tests were used to determine where significant differences occurred from baseline to end of treatment (12 weeks).||||>0.05
72463187|NCT00871143|144448764|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||Bonferroni corrections were used to reduce risk of type I error.|t-test, 2 sided|||Repeated- measures t tests were used to determine where significant differences occurred from baseline to 2 month follow up.||||> 0.05
72463188|NCT00871143|144448765|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|||||An alpha level of .05 was set (two-sided).|Mixed Models Analysis|||Linear mixed models were conducted to determine the predictive value of treatment group and/or time on GAD-7 scores.||||<0.05
72463189|NCT00871143|144448765|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED|||||A Bonferroni correction was used to decrease the risk of type I error.|t-test, 2 sided|||Repeated- measures t tests were used to determine where significant differences occurred from baseline to 12 week assessment.||||<0.01
72463190|NCT00871143|144448765|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||Bonferroni corrections were implemented to reduce the risk of type I error|t-test, 2 sided|||Repeated- measures t tests were used to determine where significant differences occurred from baseline to 2 month follow up assessment.||||> 0.05
72463191|NCT00871143|144448765|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||A Bonferroni correction was used to decrease the risk of type I error.|t-test, 2 sided|||Repeated- measures t tests were used to determine where significant differences occurred from baseline to 12 week assessment.||||>0.05
72393301|NCT03975790|144294188|SUPERIORITY|||||||0.2871|||||||Chi-squared|||Essential hypertension||||0.2871
72393302|NCT03975790|144294188|SUPERIORITY|||||||0.7356|||||||Chi-squared|||Residual codes; unclassified||||0.7356
72393303|NCT03975790|144294188|SUPERIORITY|||||||0.4975|||||||Chi-squared|||Residual codes; unclassified||||0.4975
72393304|NCT03975790|144294188|SUPERIORITY|||||||0.7143|||||||Chi-squared|||Residual codes; unclassified||||0.7143
72502064|NCT00803114|144534152|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.0|STANDARD_ERROR_OF_MEAN|0.8||0.05||95.0|-5.7|-2.3|||t-test, 2 sided|degrees of freedom 226|The epidural morphine group represents the baseline of comparison for difference in means, with the placebo group requiring additional analgesics earlier.|||-2.3|-5.7|0.05
72393305|NCT03975790|144294188|SUPERIORITY|||||||0.3559|||||||Chi-squared|||Disorders of lipid metabolism||||0.3559
72393306|NCT03975790|144294188|SUPERIORITY|||||||0.7725|||||||Chi-squared|||Disorders of lipid metabolism||||0.7725
72393307|NCT03975790|144294188|SUPERIORITY|||||||0.3875|||||||Chi-squared|||Disorders of lipid metabolism||||0.3875
72393308|NCT03975790|144294188|SUPERIORITY|||||||0.0225|||||||Chi-squared|||Back problems||||0.0225
72393309|NCT03975790|144294188|SUPERIORITY|||||||0.4427|||||||Chi-squared|||Back problems||||0.4427
72393310|NCT03975790|144294188|SUPERIORITY|||||||0.4094|||||||Chi-squared|||Back problems||||0.4094
72393311|NCT03975790|144294188|SUPERIORITY|||||||0.8775|||||||Chi-squared|||Other upper respiratory infections||||0.8775
72393312|NCT03975790|144294188|SUPERIORITY|||||||0.3525|||||||Chi-squared|||Other upper respiratory infections||||0.3525
72393313|NCT03975790|144294188|SUPERIORITY|||||||0.4724|||||||Chi-squared|||Other upper respiratory infections||||0.4724
72393314|NCT03975790|144294188|SUPERIORITY|||||||0.717|||||||Chi-squared|||Other lower respiratory disease||||0.7170
72393315|NCT03975790|144294188|SUPERIORITY|||||||0.2909|||||||Chi-squared|||Other lower respiratory disease||||0.2909
72393316|NCT03975790|144294188|SUPERIORITY|||||||0.5057|||||||Chi-squared|||Other lower respiratory disease||||0.5057
72393317|NCT03975790|144294188|SUPERIORITY|||||||0.2613|||||||Chi-squared|||Other nervous system disorders||||0.2613
72393318|NCT03975790|144294188|SUPERIORITY|||||||0.9901|||||||Chi-squared|||Other nervous system disorders||||0.9901
72393319|NCT03975790|144294188|SUPERIORITY|||||||0.4768|||||||Chi-squared|||Other nervous system disorders||||0.4768
72393320|NCT03975790|144294188|SUPERIORITY|||||||0.0219|||||||Chi-squared|||Other skin disorders||||0.0219
72393321|NCT03975790|144294188|SUPERIORITY|||||||0.5172|||||||Chi-squared|||Other skin disorders||||0.5172
72393322|NCT03975790|144294188|SUPERIORITY|||||||0.0278|||||||Chi-squared|||Other skin disorders||||0.0278
72463192|NCT00871143|144448765|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||Bonferroni corrections were used to reduce risk of type I error|t-test, 2 sided|||Repeated- measures t tests were used to determine where significant differences occurred from baseline to 2 month follow up assessment.||||> 0.05
72463193|NCT00871143|144448766|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|||||An alpha level of .05 was set (two-sided).|Mixed Models Analysis|||Linear mixed models were conducted to determine the predictive value of treatment group and/or time on BIQLI scores.||||<0.05
72463194|NCT00871143|144448766|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|||||A Bonferroni correction was used to decrease the risk of type I error.|t-test, 2 sided|||Repeated-measures t tests were then used to determine where significant differences in BIQLI occurred between baseline and end of treatment (12 weeks).||||<0.05
72463195|NCT00871143|144448766|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|||||Bonferroni corrections were used to reduce risk of type 1 error|t-test, 2 sided|||Repeated-measures t tests were then used to determine where significant differences in BIQLI occurred between baseline and 1 month follow up.||||< 0.05
72463196|NCT00871143|144448766|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||A Bonferroni correction was used to decrease the risk of type I error.|t-test, 2 sided|||Repeated-measures t tests were then used to determine where significant differences in BIQLI occurred between baseline and end of treatment (12 weeks).||||>0.05
72393323|NCT03975790|144294188|SUPERIORITY|||||||0.6103|||||||Chi-squared|||Thyroid disorders||||0.6103
72393324|NCT03975790|144294188|SUPERIORITY|||||||0.1682|||||||Chi-squared|||Thyroid disorders||||0.1682
72393325|NCT03975790|144294188|SUPERIORITY|||||||0.3654|||||||Chi-squared|||Thyroid disorders||||0.3654
72463197|NCT00871143|144448766|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||Bonferroni corrections were used|t-test, 2 sided|||Repeated-measures t tests were then used to determine where significant differences in BIQLI occurred between baseline and 1 month follow up.||||> 0.05
72463198|NCT00352053|144448767|SUPERIORITY_OR_OTHER|||||||0.55||95.0||||No adjustments for multiple comparisons were made.|Van Elteren test|P-value is from a Van Elteren test stratified by baseline genotypic sensitivity score (GSS) (without tenofovir DF) \<= or \> median (median GSS is 2).||Null hypothesis: Time-weighted average changes from baseline through Week 24 in plasma HIV-1 RNA for the tenofovir DF and placebo groups are equal. Alternative hypothesis: Time-weighted average changes from baseline through Week 24 in plasma HIV-1 RNA for the tenofovir DF and placebo groups are different (two-sided).||||0.55
72463199|NCT00352053|144448768|SUPERIORITY_OR_OTHER|||||||0.4||95.0||||No adjustments for multiple comparisons were made.|Van Elteren test|P-value is from a Van Elteren test stratified by baseline GSS (without tenofovir DF) \<= or \> median (median GSS is 2).||Null hypothesis: Time-weighted average changes from baseline through Week 48 in plasma HIV-1 RNA for the tenofovir DF and placebo groups are equal. Alternative hypothesis: Time-weighted average changes from baseline through Week 48 in plasma HIV-1 RNA for the tenofovir DF and placebo groups are different (two-sided).||||0.40
72463200|NCT00352053|144448769|SUPERIORITY_OR_OTHER|||||||0.58||95.0||||No adjustments for multiple comparisons were made.|Van Elteren test|P-value is from a Van Elteren test stratified by baseline GSS (without tenofovir DF) \<= or \> median (median GSS is 2).||Null hypothesis: Changes from baseline through Week 24 in plasma HIV-1 RNA for the tenofovir DF and placebo groups are equal. Alternative hypothesis: Changes from baseline through Week 24 in plasma HIV-1 RNA for the tenofovir DF and placebo groups are different (two-sided).||||0.58
72463201|NCT00352053|144448770|SUPERIORITY_OR_OTHER|||||||0.37||95.0||||No adjustments for multiple comparisons were made.|Van Elteren test|P-value is from a Van Elteren test stratified by baseline GSS (without tenofovir DF) \<= or \> median (median GSS is 2).||Null hypothesis: Changes from baseline through Week 48 in plasma HIV-1 RNA for the tenofovir DF and placebo groups are equal. Alternative hypothesis: Changes from baseline through Week 48 in plasma HIV-1 RNA for the tenofovir DF and placebo groups are different (two-sided).||||0.37
72463202|NCT00352053|144448777|SUPERIORITY_OR_OTHER|||||||0.71||95.0||||No adjustments for multiple comparisons were made.|Van Elteren test|P-value is from a Van Elteren test stratified by baseline GSS (without tenofovir DF) \<= or \> median (median GSS is 2).||Null hypothesis: Changes from baseline through Week 24 in plasma CD4 count for the tenofovir DF and placebo groups are equal. Alternative hypothesis: Changes from baseline through Week 24 in CD4 count for the tenofovir DF and placebo groups are different (two-sided).||||0.71
72502065|NCT00803114|144534153|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.3|STANDARD_ERROR_OF_MEAN|0.3||0.05||95.0|0.7|1.8|||t-test, 2 sided|degrees of freedom 212|Difference in VAS score when compared to the baseline group, subjects receiving epidural morphine|||1.8|0.7|0.05
72502066|NCT00803114|144534154|SUPERIORITY_OR_OTHER|||||||0.8||||||Fisher's exact test result did not reveal statistically significant differences between expected and real frequencies in any of the categories.|Fisher Exact|||||||0.80
72502067|NCT01697345|144534156|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.092|STANDARD_DEVIATION|6.0378|<|0.0005|TWO_SIDED|95.0|-13.928|-6.256|||t-test, 2 sided|||||-6.256|-13.928|<0.0005
72502068|NCT01697345|144534157|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.3|STANDARD_DEVIATION|0.88|<|0.0005|TWO_SIDED|95.0|-1.859|-0.741|||t-test, 2 sided|||||-0.741|-1.859|<0.0005
72393326|NCT03975790|144294188|SUPERIORITY|||||||0.7637|||||||Chi-squared|||Other bone disease/musculoskeletal deformities||||0.7637
72393327|NCT03975790|144294188|SUPERIORITY|||||||0.8693|||||||Chi-squared|||Other bone disease/musculoskeletal deformities||||0.8693
72393328|NCT03975790|144294188|SUPERIORITY|||||||0.7349|||||||Chi-squared|||Other bone disease/musculoskeletal deformities||||0.7349
72393329|NCT03975790|144294188|SUPERIORITY|||||||0.7324|||||||Chi-squared|||Malaise/fatigue||||0.7324
72393330|NCT03975790|144294188|SUPERIORITY|||||||0.4182|||||||Chi-squared|||Malaise/fatigue||||0.4182
72393331|NCT03975790|144294188|SUPERIORITY|||||||0.62|||||||Chi-squared|||Malaise/fatigue||||0.6200
72393332|NCT03975790|144294188|SUPERIORITY|||||||0.6064|||||||Chi-squared|||Esophageal disorders||||0.6064
72393333|NCT03975790|144294188|SUPERIORITY|||||||0.636|||||||Chi-squared|||Esophageal disorders||||0.6360
72393334|NCT03975790|144294188|SUPERIORITY|||||||0.9445|||||||Chi-squared|||Esophageal disorders||||0.9445
72393335|NCT03975790|144294188|SUPERIORITY|||||||0.8135|||||||Chi-squared|||Nutritional deficiencies||||0.8135
72463203|NCT00352053|144448778|SUPERIORITY_OR_OTHER|||||||0.47||95.0||||No adjustments for multiple comparisons were made.|Van Elteren test|P-value is from a Van Elteren test stratified by baseline GSS (without tenofovir DF) \<= or \> median (median GSS is 2).||Null hypothesis: Changes from baseline through Week 48 in plasma CD4 count for the tenofovir DF and placebo groups are equal. Alternative hypothesis: Changes from baseline through Week 48 in CD4 count for the tenofovir DF and placebo groups are different (two-sided).||||0.47
72463204|NCT00352053|144448785|SUPERIORITY_OR_OTHER|||||||0.26||95.0||||No adjustments for multiple comparisons were made.|Van Elteren test|P-value is from a Van Elteren test stratified by baseline GSS (without tenofovir DF) \<= or \> median (median GSS is 2).||Null hypothesis: Changes from baseline through Week 24 in plasma CD4% for the tenofovir DF and placebo groups are equal. Alternative hypothesis: Changes from baseline through Week 24 in CD4% for the tenofovir DF and placebo groups are different (two-sided).||||0.26
72463205|NCT00352053|144448786|SUPERIORITY_OR_OTHER|||||||0.63||95.0||||No adjustments for multiple comparisons were made.|Van Elteren test|P-value is from a Van Elteren test stratified by baseline GSS (without tenofovir DF) \<= or \> median (median GSS is 2).||Null hypothesis: Changes from baseline through Week 48 in plasma CD4% for the tenofovir DF and placebo groups are equal. Alternative hypothesis: Changes from baseline through Week 48 in CD4% for the tenofovir DF and placebo groups are different (two-sided).||||0.63
72463206|NCT00352053|144448793|SUPERIORITY_OR_OTHER|||||||0.67||95.0||||No adjustments for multiple comparisons were made.|Fisher Exact|No adjustments were made.||Null hypothesis: Percentage of participants who had at least a 1.0 log10 copies/mL decrease from baseline to Week 24 in HIV-1 RNA for the tenofovir DF and placebo groups is equal. Alternative hypothesis: Percentage of participants who had at least a 1.0 log10 copies/mL decrease from baseline to Week 24 in HIV-1 RNA for the tenofovir DF and placebo groups is different (two-sided).||||0.67
72463207|NCT00352053|144448794|SUPERIORITY_OR_OTHER|||||||0.67||95.0||||No adjustments for multiple comparisons were made.|Fisher Exact|No adjustments were made.||Null hypothesis: Percentage of participants who had at least a 1.0 log10 copies/mL decrease from baseline to Week 48 in HIV-1 RNA for the tenofovir DF and placebo groups is equal. Alternative hypothesis: Percentage of participants who had at least a 1.0 log10 copies/mL decrease from baseline to Week 48 in HIV-1 RNA for the tenofovir DF and placebo groups is different (two-sided).||||0.67
72463208|NCT00352053|144448801|SUPERIORITY_OR_OTHER|||||||1||95.0||||No adjustments for multiple comparisons were made.|Fisher Exact|No adjustments were made.||Null hypothesis: Percentage of participants with HIV-1 RNA \< 400 copies/mL at Week 24 for the tenofovir DF and placebo groups is equal. Alternative hypothesis: Percentage of participants with HIV-1 RNA \< 400 copies/mL at Week 24 for the tenofovir DF and placebo groups is different (two-sided).||||1.00
72463209|NCT00352053|144448802|SUPERIORITY_OR_OTHER|||||||0.38||95.0||||No adjustments for multiple comparisons were made.|Fisher Exact|No adjustments were made.||Null hypothesis: Percentage of participants with HIV-1 RNA \< 400 copies/mL at Week 48 for the tenofovir DF and placebo groups is equal. Alternative hypothesis: Percentage of participants with HIV-1 RNA \< 400 copies/mL at Week 48 for the tenofovir DF and placebo groups is different (two-sided).||||0.38
72502069|NCT01697345|144534158|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-1.625|STANDARD_DEVIATION|1.369||0.002|TWO_SIDED|95.0|-2.495|-0.755|||t-test, 2 sided|||||-0.755|-2.495|0.002
72502070|NCT01697345|144534159|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.5|STANDARD_DEVIATION|1.876||0.018|TWO_SIDED|95.0|-2.692|-0.308|||t-test, 2 sided|||||-0.308|-2.692|0.018
72563810|NCT04100096|144659005|SUPERIORITY||Mean Difference (Final Values)|0.38||||0|TWO_SIDED|95.0|0.21|0.55||ANCOVA model, with treatment as main effect and baseline value as covariate, is used for change from baseline of case comparisons.|ANCOVA|||Week 4||0.55|0.21|0
72563811|NCT04100096|144659005|SUPERIORITY||Mean Difference (Final Values)|0.41||||0.0001|TWO_SIDED|95.0|0.21|0.61||ANCOVA model, with treatment as main effect and baseline value as covariate, is used for change from baseline of case comparisons.|ANCOVA|||Week 6||0.61|0.21|0.0001
72463210|NCT00352053|144448809|SUPERIORITY_OR_OTHER|||||||0.22||95.0||||No adjustments for multiple comparisons were made.|Fisher Exact|No adjustments were made.||Null hypothesis: Percentage of participants with HIV-1 RNA \< 50 copies/mL at Week 24 for the tenofovir DF and placebo groups is equal. Alternative hypothesis: Percentage of participants with HIV-1 RNA \< 50 copies/mL at Week 24 for the tenofovir DF and placebo groups is different (two-sided).||||0.22
72463211|NCT00352053|144448810|SUPERIORITY_OR_OTHER|||||||0.48||95.0||||No adjustments for multiple comparisons were made.|Fisher Exact|No adjustments were made.||Null hypothesis: Percentage of participants with HIV-1 RNA \< 50 copies/mL at Week 48 for the tenofovir DF and placebo groups is equal. Alternative hypothesis: Percentage of participants with HIV-1 RNA \< 50 copies/mL at Week 48 for the tenofovir DF and placebo groups is different (two-sided).||||0.48
72502071|NCT01697345|144534160|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.2|STANDARD_DEVIATION|1.18168||0.005|TWO_SIDED|95.0|-1.9508|-0.4492|||t-test, 2 sided|||||-.44920|-1.95080|0.005
72502072|NCT01697345|144534161|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.9|STANDARD_DEVIATION|1.355||0.001|TWO_SIDED|95.0|-2.761|-1.039|||t-test, 2 sided|||||-1.039|-2.761|0.001
72502073|NCT01697345|144534162|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.567|STANDARD_DEVIATION|1.793|<|0.0005|TWO_SIDED|95.0|-3.706|-1.428|||t-test, 2 sided|||||-1.428|-3.706|<0.0005
72502074|NCT01446809|144534172|SUPERIORITY|||||||0.4|||||||Wilcoxon (Mann-Whitney)|||||||0.4
72502075|NCT01446809|144534173|SUPERIORITY|||||||0.13|||||||Wilcoxon (Mann-Whitney)|||||||0.13
72502076|NCT01212445|144534207|SUPERIORITY_OR_OTHER||Treatment Success Rate|0.192||||0.179|TWO_SIDED|95.0|0.096|0.325|||Fisher Exact|||The treatment success rate was defined as the number of participants in a treatment group with treatment successes (BM with no straining or hard/lumpy stools) divided by the total number of participants in the treatment group. Treatment success rate was calculated for each dose group along with 95% confidence intervals (CI) based on exact binomial statistics. Treatment success rates were compared between each pair of treatments using an exact 2-sided test (Fisher's).||0.325|0.096|0.1790
72393336|NCT03975790|144294188|SUPERIORITY|||||||0.6705|||||||Chi-squared|||Nutritional deficiencies||||0.6705
72393337|NCT03975790|144294188|SUPERIORITY|||||||0.8331|||||||Chi-squared|||Nutritional deficiencies||||0.8331
72463212|NCT00352053|144448817|SUPERIORITY_OR_OTHER|||||||0.29||95.0||||No adjustments for multiple comparisons were made.|Log Rank|No adjustments were made.||Null hypothesis: The survival functions for the tenofovir DF and placebo groups up to Week 48 are equal. Alternative hypothesis: The survival functions for the tenofovir DF and placebo groups up to Week 48 are different (two-sided).||||0.29
72463213|NCT01066897|144448837|OTHER|||||||0.002|||||||Chi-squared|||||||.002
72463214|NCT01066897|144448838|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.368|STANDARD_DEVIATION|0.44||0.067|TWO_SIDED||||||t-test, 2 sided|One sample t-test to determine if the % change in HAMD was different from 0||For the 2 dropouts, used LOCF.||||.067
72463215|NCT03209050|144448842|OTHER|||||||0.5|||||||Clopper-Pearson 95% CI|||||||0.5
72463216|NCT00139659|144448844|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.034|STANDARD_ERROR_OF_MEAN|0.028||||90.0|-0.08|0.011|||longitudinal data analysis model|Confidence interval of least squares (LS) mean difference (INH - SC) between annual rates of change for the two treatment groups.|Primary analysis model includes terms of Treatment, Time, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on day of randomization.|Treatment group difference (Exubera minus subcutaneous insulin): annualized rate of change over time. Longitudinal data analysis methods with random effects were used to model the pulmonary function test (PFT) measurements. Random effects included the intercept and slope with respect to time (visit); all remaining effects were fixed. The estimated rate of change over time for each treatment group was derived from this model.||0.011|-0.080|
72463217|NCT00139659|144448845|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.025|STANDARD_ERROR_OF_MEAN|0.024||||90.0|-0.065|0.015|||Mixed Models Analysis|||Week 1; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||0.015|-0.065|
72463218|NCT00139659|144448845|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.034|STANDARD_ERROR_OF_MEAN|0.024||||90.0|-0.073|0.006|||Mixed Models Analysis|||Week 2; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||0.006|-0.073|
72563812|NCT04100096|144659005|SUPERIORITY||Mean Difference (Final Values)|0.56||||0|TWO_SIDED|95.0|0.33|0.8||ANCOVA model, with treatment as main effect and baseline value as covariate, is used for change from baseline of case comparisons.|ANCOVA|||Week 8||0.80|0.33|0
72563813|NCT04100096|144659005|SUPERIORITY||Mean Difference (Final Values)|0.61||||0|TWO_SIDED|95.0|0.34|0.88||ANCOVA model, with treatment as main effect and baseline value as covariate, is used for change from baseline of case comparisons.|ANCOVA|||Week 10||0.88|0.34|0
72463219|NCT00139659|144448845|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.024|STANDARD_ERROR_OF_MEAN|0.024||||90.0|-0.063|0.016|||Mixed Models Analysis|||Week 3; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||0.016|-0.063|
72463220|NCT00139659|144448845|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.035|STANDARD_ERROR_OF_MEAN|0.024||||90.0|-0.075|0.004|||Mixed Models Analysis|||Week 4; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||0.004|-0.075|
72463221|NCT00139659|144448845|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.027|STANDARD_ERROR_OF_MEAN|0.024||||90.0|-0.067|0.012|||Mixed Models Analysis|||Week 6; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||0.012|-0.067|
72463222|NCT00139659|144448845|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.033|STANDARD_ERROR_OF_MEAN|0.025||||90.0|-0.073|0.008|||Mixed Models Analysis|||Week 12; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||0.008|-0.073|
72463223|NCT00139659|144448845|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.018|STANDARD_ERROR_OF_MEAN|0.025||||90.0|-0.059|0.023|||Mixed Models Analysis|||Week 18; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||0.023|-0.059|
72463224|NCT00139659|144448845|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.025||||90.0|-0.052|0.031|||Mixed Models Analysis|||Week 26; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||0.031|-0.052|
72463225|NCT00139659|144448845|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.025|STANDARD_ERROR_OF_MEAN|0.026||||90.0|-0.068|0.017|||Mixed Models Analysis|||Week 39; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||0.017|-0.068|
72463226|NCT00139659|144448845|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.073|STANDARD_ERROR_OF_MEAN|0.027||||90.0|-0.117|-0.029|||Mixed Models Analysis|||Week 52; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||-0.029|-0.117|
72463227|NCT00139659|144448845|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.061|STANDARD_ERROR_OF_MEAN|0.028||||90.0|-0.108|-0.015|||Mixed Models Analysis|||Week 52 (LOCF); Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||-0.015|-0.108|
72563814|NCT04100096|144659005|SUPERIORITY||Mean Difference (Final Values)|0.52||||0.0004|TWO_SIDED|95.0|0.23|0.8||ANCOVA model, with treatment as main effect and baseline value as covariate, is used for change from baseline of case comparisons.|ANCOVA|||Week 12||0.80|0.23|0.0004
72393338|NCT03975790|144294188|SUPERIORITY|||||||0.4158|||||||Chi-squared|||Other nutritional; endocrine; and metabolic disorders||||0.4158
72463228|NCT00139659|144448846|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.327|STANDARD_ERROR_OF_MEAN|0.214||||90.0|-0.679|0.026|||Mixed Models Analysis|||Week 1; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||0.026|-0.679|
72463229|NCT00139659|144448846|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.378|STANDARD_ERROR_OF_MEAN|0.213||||90.0|-0.729|-0.027|||Mixed Models Analysis|||Week 2; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||-0.027|-0.729|
72463230|NCT00139659|144448846|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.346|STANDARD_ERROR_OF_MEAN|0.213||||90.0|-0.696|0.004|||Mixed Models Analysis|||Week 3; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||0.004|-0.696|
72463231|NCT00139659|144448846|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.496|STANDARD_ERROR_OF_MEAN|0.213||||90.0|-0.847|-0.145|||Mixed Models Analysis|||Week 4; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||-0.145|-0.847|
72463232|NCT00139659|144448846|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.61|STANDARD_ERROR_OF_MEAN|0.213||||90.0|-0.96|-0.26|||Mixed Models Analysis|||Week 6; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||-0.260|-0.960|
72463233|NCT00139659|144448846|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.36|STANDARD_ERROR_OF_MEAN|0.219||||90.0|-0.721|0.001|||Mixed Models Analysis|||Week 12; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||0.001|-0.721|
72463234|NCT00139659|144448846|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.291|STANDARD_ERROR_OF_MEAN|0.221||||90.0|-0.655|0.073|||Mixed Models Analysis|||Week 18; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||0.073|-0.655|
72463235|NCT00139659|144448846|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.42|STANDARD_ERROR_OF_MEAN|0.224||||90.0|-0.788|-0.052|||Mixed Models Analysis|||Week 26; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||-0.052|-0.788|
72463236|NCT00139659|144448846|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.337|STANDARD_ERROR_OF_MEAN|0.231||||90.0|-0.717|0.042|||Mixed Models Analysis|||Week 39; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||0.042|-0.717|
72393339|NCT03975790|144294188|SUPERIORITY|||||||0.636|||||||Chi-squared|||Other nutritional; endocrine; and metabolic disorders||||0.6360
72463237|NCT00139659|144448846|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.789|STANDARD_ERROR_OF_MEAN|0.238||||90.0|-1.181|-0.397|||Mixed Models Analysis|||Week 52; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||-0.397|-1.181|
72463238|NCT00139659|144448846|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.786|STANDARD_ERROR_OF_MEAN|0.238||||90.0|-1.178|-0.393|||Mixed Models Analysis|||Week 52 (LOCF); Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||-0.393|-1.178|
72463239|NCT00139659|144448849|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.021|STANDARD_ERROR_OF_MEAN|0.027||||90.0|-0.066|0.023|||Mixed Models Analysis|||Week 1; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model): includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||0.023|-0.066|
72463240|NCT00139659|144448849|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.027||||90.0|-0.044|0.044|||Mixed Models Analysis|||Week 2; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model): includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||0.044|-0.044|
72463241|NCT00139659|144448849|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.012|STANDARD_ERROR_OF_MEAN|0.027||||90.0|-0.056|0.032|||Mixed Models Analysis|||Week 3; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model): includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||0.032|-0.056|
72463242|NCT00139659|144448849|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.004|STANDARD_ERROR_OF_MEAN|0.027||||90.0|-0.048|0.041|||Mixed Models Analysis|||Week 4; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model): includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||0.041|-0.048|
72563815|NCT04100096|144659007|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.1687|TWO_SIDED|95.0|-0.04|0.25||ANCOVA model, with treatment as main effect and baseline value as covariate, is used for change from baseline of case comparisons.|ANCOVA|||Week 6||0.25|-0.04|0.1687
72393340|NCT03975790|144294188|SUPERIORITY|||||||0.3336|||||||Chi-squared|||Other nutritional; endocrine; and metabolic disorders||||0.3336
72393341|NCT03975790|144294188|SUPERIORITY|||||||0.6402|||||||Chi-squared|||Diabetes mellitus without complication||||0.6402
72393342|NCT03975790|144294188|SUPERIORITY|||||||0.8068|||||||Chi-squared|||Diabetes mellitus without complication||||0.8068
72463243|NCT00139659|144448849|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.045|STANDARD_ERROR_OF_MEAN|0.027||||90.0|-0.089|-0.001|||Mixed Models Analysis|||Week 6; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model): includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||-0.001|-0.089|
72463244|NCT00139659|144448849|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.028||||90.0|-0.035|0.056|||Mixed Models Analysis|||Week 12; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model): includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||0.056|-0.035|
72463245|NCT00139659|144448849|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.018|STANDARD_ERROR_OF_MEAN|0.028||||90.0|-0.028|0.064|||Mixed Models Analysis|||Week 18; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model): includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||0.064|-0.028|
72393343|NCT03975790|144294188|SUPERIORITY|||||||0.5983|||||||Chi-squared|||Diabetes mellitus without complication||||0.5983
72393344|NCT03975790|144294188|SUPERIORITY|||||||0.9759|||||||Chi-squared|||Other/unspecified benign neoplasm||||0.9759
72393345|NCT03975790|144294188|SUPERIORITY|||||||0.136|||||||Chi-squared|||Other/unspecified benign neoplasm||||0.1360
72393346|NCT03975790|144294188|SUPERIORITY|||||||0.1815|||||||Chi-squared|||Other/unspecified benign neoplasm||||0.1815
72393347|NCT03975790|144294188|SUPERIORITY|||||||0.2731|||||||Chi-squared|||Genitourinary symptoms/ill-defined conditions||||0.2731
72463246|NCT00139659|144448849|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.005|STANDARD_ERROR_OF_MEAN|0.028||||90.0|-0.051|0.041|||Mixed Models Analysis|||Week 26; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model): includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||0.041|-0.051|
72463247|NCT00139659|144448849|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.022|STANDARD_ERROR_OF_MEAN|0.029||||90.0|-0.07|0.026|||Mixed Models Analysis|||Week 39; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model): includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||0.026|-0.070|
72463248|NCT00139659|144448849|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.015|STANDARD_ERROR_OF_MEAN|0.03||||90.0|-0.064|0.034|||Mixed Models Analysis|||Week 52; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model): includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||0.034|-0.064|
72463249|NCT00139659|144448849|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.015|STANDARD_ERROR_OF_MEAN|0.031||||90.0|-0.067|0.037|||Mixed Models Analysis|||Week 52 (LOCF); Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model): includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||0.037|-0.067|
72463250|NCT00139659|144448850|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.632|STANDARD_ERROR_OF_MEAN|0.697||||90.0|-1.778|0.514|||Mixed Models Analysis|||Week 1; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model): includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||0.514|-1.778|
72463251|NCT00139659|144448850|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.668||||90.0|-1.079|1.12|||Mixed Models Analysis|||Week 2; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model): includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||1.120|-1.079|
72463252|NCT00139659|144448850|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.582|STANDARD_ERROR_OF_MEAN|0.679||||90.0|-0.535|1.7|||Mixed Models Analysis|||Week 3; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model): includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||1.700|-0.535|
72463253|NCT00139659|144448850|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.054|STANDARD_ERROR_OF_MEAN|0.687||||90.0|-1.184|1.077|||Mixed Models Analysis|||Week 4; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model): includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||1.077|-1.184|
72502077|NCT01212445|144534207|SUPERIORITY_OR_OTHER||Treatment Success Rate|0.314||||1|TWO_SIDED|95.0|0.191|0.459|||Fisher Exact|||The treatment success rate was calculated as the number of participants in a treatment group with treatment successes (BM with no straining or hard/lumpy stools) divided by the total number of participants in the treatment group. Treatment success rate was calculated for each dose group along with 95% confidence intervals (CI) based on exact binomial statistics. Treatment success rates were compared between each pair of treatments using an exact 2-sided test (Fisher's).||0.459|0.191|1.0000
72393348|NCT03975790|144294188|SUPERIORITY|||||||0.8327|||||||Chi-squared|||Genitourinary symptoms/ill-defined conditions||||0.8327
72393349|NCT03975790|144294188|SUPERIORITY|||||||0.342|||||||Chi-squared|||Genitourinary symptoms/ill-defined conditions||||0.3420
72393350|NCT03975790|144294189|SUPERIORITY|||||||0.059|||||||Chi-squared|||Rheumatoid arthritis/related disease||||0.0590
72393351|NCT03975790|144294189|SUPERIORITY|||||||0.7055|||||||Chi-squared|||Rheumatoid arthritis/related disease||||0.7055
72393352|NCT03975790|144294189|SUPERIORITY|||||||0.3088|||||||Chi-squared|||Rheumatoid arthritis/related disease||||0.3088
72393353|NCT03975790|144294189|SUPERIORITY|||||||0.0036|||||||Chi-squared|||Other aftercare||||0.0036
72393354|NCT03975790|144294189|SUPERIORITY|||||||0.3772|||||||Chi-squared|||Other aftercare||||0.3772
72393355|NCT03975790|144294189|SUPERIORITY|||||||0.3|||||||Chi-squared|||Other aftercare||||0.3000
72393356|NCT03975790|144294189|SUPERIORITY|||||||0.7354|||||||Chi-squared|||Other connective tissue disease||||0.7354
72393357|NCT03975790|144294189|SUPERIORITY|||||||0.1435|||||||Chi-squared|||Other connective tissue disease||||0.1435
72563816|NCT04100096|144659007|SUPERIORITY||Mean Difference (Final Values)|0.12||||0.1874|TWO_SIDED|95.0|-0.06|0.29||Analysis of covariance (ANCOVA) model, with treatment as main effect and baseline value as covariate, is used for change from baseline of case comparisons.|ANCOVA|||Week 12||0.29|-0.06|0.1874
72563817|NCT04100096|144659008|SUPERIORITY||Mean Difference (Final Values)|-0.12||||0.0974|TWO_SIDED|95.0|-0.25|0.02||ANCOVA model, with treatment as main effect and baseline value as covariate, is used for change from baseline of case comparisons|ANCOVA|||Week 6||0.02|-0.25|0.0974
72393358|NCT03975790|144294189|SUPERIORITY|||||||0.2876|||||||Chi-squared|||Other connective tissue disease||||0.2876
72393359|NCT03975790|144294189|SUPERIORITY|||||||0.2848|||||||Chi-squared|||Other non-traumatic joint disorders||||0.2848
72393360|NCT03975790|144294189|SUPERIORITY|||||||0.183|||||||Chi-squared|||Other non-traumatic joint disorders||||0.1830
72393361|NCT03975790|144294189|SUPERIORITY|||||||0.6453|||||||Chi-squared|||Other non-traumatic joint disorders||||0.6453
72393362|NCT03975790|144294189|SUPERIORITY|||||||0.8717|||||||Chi-squared|||Medical examination/evaluation||||0.8717
72393363|NCT03975790|144294189|SUPERIORITY|||||||0.8717|||||||Chi-squared|||Medical examination/evaluation||||0.8717
72393364|NCT03975790|144294189|SUPERIORITY|||||||0.3422|||||||Chi-squared|||Medical examination/evaluation||||0.3422
72393365|NCT03975790|144294189|SUPERIORITY|||||||0.3465|||||||Chi-squared|||Other suspected conditions||||0.3465
72393366|NCT03975790|144294189|SUPERIORITY|||||||0.4953|||||||Chi-squared|||Other suspected conditions||||0.4953
72393367|NCT03975790|144294189|SUPERIORITY|||||||0.9796|||||||Chi-squared|||Other suspected conditions||||0.9796
72393368|NCT03975790|144294189|SUPERIORITY|||||||0.4187|||||||Chi-squared|||Immunizations/screening for infectious disease||||0.4187
72393369|NCT03975790|144294189|SUPERIORITY|||||||0.151|||||||Chi-squared|||Immunizations/screening for infectious disease||||0.1510
72393370|NCT03975790|144294189|SUPERIORITY|||||||0.0751|||||||Chi-squared|||Immunizations/screening for infectious disease||||0.0751
72393371|NCT03975790|144294189|SUPERIORITY|||||||0.7577|||||||Chi-squared|||Osteoarthritis||||0.7577
72463254|NCT00139659|144448850|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.535|STANDARD_ERROR_OF_MEAN|0.694||||90.0|-1.677|0.608|||Mixed Models Analysis|||Week 6; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model): includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||0.608|-1.677|
72463255|NCT00139659|144448850|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.905|STANDARD_ERROR_OF_MEAN|0.674||||90.0|-2.014|0.203|||Mixed Models Analysis|||Week 12; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model): includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||0.203|-2.014|
72563818|NCT04100096|144659008|SUPERIORITY||Mean Difference (Final Values)|-0.06||||0.391|TWO_SIDED|95.0|-0.2|0.08||ANCOVA model, with treatment as main effect and baseline value as covariate, is used for change from baseline of case comparisons|ANCOVA|||Week 12||0.08|-0.20|0.3910
72563819|NCT04100096|144659009|SUPERIORITY||Mean Difference (Final Values)|0.15||||0.0063|TWO_SIDED|9.0|0.04|0.26||ANCOVA model, with treatment as main effect and baseline value as covariate, is used for change from baseline of case comparisons.|ANCOVA|||Week 6||0.26|0.04|0.0063
72393372|NCT03975790|144294189|SUPERIORITY|||||||0.802|||||||Chi-squared|||Osteoarthritis||||0.8020
72393373|NCT03975790|144294189|SUPERIORITY|||||||0.9879|||||||Chi-squared|||Osteoarthritis||||0.9879
72393374|NCT03975790|144294189|SUPERIORITY|||||||0.1717|||||||Chi-squared|||Essential hypertension||||0.1717
72393375|NCT03975790|144294189|SUPERIORITY|||||||0.3065|||||||Chi-squared|||Essential hypertension||||0.3065
72393376|NCT03975790|144294189|SUPERIORITY|||||||0.992|||||||Chi-squared|||Essential hypertension||||0.9920
72393377|NCT03975790|144294189|SUPERIORITY|||||||0.4626|||||||Chi-squared|||Residual codes; unclassified||||0.4626
72393378|NCT03975790|144294189|SUPERIORITY|||||||0.8922|||||||Chi-squared|||Residual codes; unclassified||||0.8922
72393379|NCT03975790|144294189|SUPERIORITY|||||||0.7143|||||||Chi-squared|||Residual codes; unclassified||||0.7143
72393380|NCT03975790|144294189|SUPERIORITY|||||||0.8212|||||||Chi-squared|||Disorders of lipid metabolism||||0.8212
72393381|NCT03975790|144294189|SUPERIORITY|||||||0.5732|||||||Chi-squared|||Disorders of lipid metabolism||||0.5732
72393382|NCT03975790|144294189|SUPERIORITY|||||||0.7319|||||||Chi-squared|||Disorders of lipid metabolism||||0.7319
72393383|NCT03975790|144294189|SUPERIORITY|||||||0.9272|||||||Chi-squared|||Back problems||||0.9272
72393384|NCT03975790|144294189|SUPERIORITY|||||||0.1441|||||||Chi-squared|||Back problems||||0.1441
72393385|NCT03975790|144294189|SUPERIORITY|||||||0.1859|||||||Chi-squared|||Back problems||||0.1859
72393386|NCT03975790|144294189|SUPERIORITY|||||||0.3109|||||||Chi-squared|||Other upper respiratory infections||||0.3109
72393387|NCT03975790|144294189|SUPERIORITY|||||||0.3313|||||||Chi-squared|||Other upper respiratory infections||||0.3313
72393388|NCT03975790|144294189|SUPERIORITY|||||||0.1279|||||||Chi-squared|||Other upper respiratory infections||||0.1279
72393389|NCT03975790|144294189|SUPERIORITY|||||||0.7575|||||||Chi-squared|||Other lower respiratory disease||||0.7575
72393390|NCT03975790|144294189|SUPERIORITY|||||||0.1583|||||||Chi-squared|||Other lower respiratory disease||||0.1583
72393391|NCT03975790|144294189|SUPERIORITY|||||||0.1569|||||||Chi-squared|||Other lower respiratory disease||||0.1569
72393392|NCT03975790|144294189|SUPERIORITY|||||||0.0745|||||||Chi-squared|||Other nervous system disorders||||0.0745
72393393|NCT03975790|144294189|SUPERIORITY|||||||0.0933|||||||Chi-squared|||Other nervous system disorders||||0.0933
72393394|NCT03975790|144294189|SUPERIORITY|||||||0.791|||||||Chi-squared|||Other nervous system disorders||||0.7910
72393395|NCT03975790|144294189|SUPERIORITY|||||||0.6755|||||||Chi-squared|||Other skin disorders||||0.6755
72393396|NCT03975790|144294189|SUPERIORITY|||||||0.4183|||||||Chi-squared|||Other skin disorders||||0.4183
72393397|NCT03975790|144294189|SUPERIORITY|||||||0.6749|||||||Chi-squared|||Other skin disorders||||0.6749
72393398|NCT03975790|144294189|SUPERIORITY|||||||0.6626|||||||Chi-squared|||Thyroid disorders||||0.6626
72393399|NCT03975790|144294189|SUPERIORITY|||||||0.5766|||||||Chi-squared|||Thyroid disorders||||0.5766
72393400|NCT03975790|144294189|SUPERIORITY|||||||0.8376|||||||Chi-squared|||Thyroid disorders||||0.8376
72463256|NCT00139659|144448850|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.212|STANDARD_ERROR_OF_MEAN|0.675||||90.0|-0.899|1.323|||Mixed Models Analysis|||Week 18; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model): includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||1.323|-0.899|
72463257|NCT00139659|144448850|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.044|STANDARD_ERROR_OF_MEAN|0.683||||90.0|-1.08|1.169|||Mixed Models Analysis|||Week 26; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model): includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||1.169|-1.080|
72463258|NCT00139659|144448850|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.24|STANDARD_ERROR_OF_MEAN|0.694||||90.0|-1.382|0.902|||Mixed Models Analysis|||Week 39; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model): includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||0.902|-1.382|
72463259|NCT00139659|144448850|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.503|STANDARD_ERROR_OF_MEAN|0.711||||90.0|-1.673|0.668|||Mixed Models Analysis|||Week 52; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model): includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||0.668|-1.673|
72463260|NCT00139659|144448864|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.503|STANDARD_ERROR_OF_MEAN|0.216||||90.0|-0.858|-0.148|||Longitudinal data analysis model|Confidence interval of least squares (LS) mean difference (INH - SC) between annual rates of change for the two treatment groups.|Primary analysis model includes terms of Treatment, Time, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on day of randomization.|Treatment group difference (Exubera minus subcutaneous insulin): annualized rate of change over time. Longitudinal data analysis methods with random effects were used to model the pulmonary function test (PFT) measurements. Random effects included the intercept and slope with respect to time (visit); all remaining effects were fixed. The estimated rate of change over time for each treatment group was derived from this model.||-0.148|-0.858|
72463261|NCT00139659|144448868|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.11|STANDARD_ERROR_OF_MEAN|0.1||||90.0|-0.06|0.28|||Mixed Models Analysis|||Week 6; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of treatment, Week, Baseline HbA1c, Center, and Type of Diabetes.||0.28|-0.06|
72463262|NCT00139659|144448868|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.21|STANDARD_ERROR_OF_MEAN|0.1||||90.0|0.04|0.38|||Mixed Models Analysis|||Week 12; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of treatment, Week, Baseline HbA1c, Center, and Type of Diabetes.||0.38|0.04|
72393401|NCT03975790|144294189|SUPERIORITY|||||||0.2857|||||||Chi-squared|||Other bone disease/musculoskeletal deformities||||0.2857
72463263|NCT00139659|144448868|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.17|STANDARD_ERROR_OF_MEAN|0.11||||90.0|-0.01|0.34|||Mixed Models Analysis|||Week 26; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of treatment, Week, Baseline HbA1c, Center, and Type of Diabetes.||0.34|-0.01|
72463264|NCT00139659|144448868|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.14|STANDARD_ERROR_OF_MEAN|0.11||||90.0|-0.03|0.32|||Mixed Models Analysis|||Week 39; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of treatment, Week, Baseline HbA1c, Center, and Type of Diabetes.||0.32|-0.03|
72463265|NCT00139659|144448868|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.06|STANDARD_ERROR_OF_MEAN|0.11||||90.0|-0.12|0.24|||Mixed Models Analysis|||Week 52; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of treatment, Week, Baseline HbA1c, Center, and Type of Diabetes.||0.24|-0.12|
72463266|NCT00139659|144448868|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.12||||90.0|-0.19|0.22|||Mixed Models Analysis|||Week 52 (LOCF); Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of treatment, Week, Baseline HbA1c, Center, and Type of Diabetes.||0.22|-0.19|
72463267|NCT00139659|144448869|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.615|STANDARD_ERROR_OF_MEAN|7.874||||90.0|-2.351|23.581|||Mixed Models Analysis|Confidence interval for the LS mean of that particular treatment.||Week 6; Analysis of change from Baseline in fasting plasma glucose: Inhaled Insulin - Subcutaneouas Insulin. Adjusted (Primary Analysis Model): includes terms of Treatment, Week, Baseline, Fasting Plasma Glucose, Center, and Type of Diabetes.||23.581|-2.351|
72393402|NCT03975790|144294189|SUPERIORITY|||||||0.956|||||||Chi-squared|||Other bone disease/musculoskeletal deformities||||0.9560
72463268|NCT00139659|144448869|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.942|STANDARD_ERROR_OF_MEAN|7.804||||90.0|-19.79|5.909|||Mixed Models Analysis|||Week 12; Analysis of change from Baseline in fasting plasma glucose: Inhaled Insulin - Subcutaneouas Insulin. Adjusted (Primary Analysis Model): includes terms of Treatment, Week, Baseline, Fasting Plasma Glucose, Center, and Type of Diabetes.||5.909|-19.79|
72463269|NCT00139659|144448869|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.622|STANDARD_ERROR_OF_MEAN|7.897||||90.0|-17.63|8.382|||Mixed Models Analysis|||Week 26; Analysis of change from Baseline in fasting plasma glucose: Inhaled Insulin - Subcutaneouas Insulin. Adjusted (Primary Analysis Model): includes terms of Treatment, Week, Baseline, Fasting Plasma Glucose, Center, and Type of Diabetes.||8.382|-17.63|
72463270|NCT00139659|144448869|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.828|STANDARD_ERROR_OF_MEAN|7.888||||90.0|-11.16|14.817|||Mixed Models Analysis|||Week 39; Analysis of change from Baseline in fasting plasma glucose: Inhaled Insulin - Subcutaneouas Insulin. Adjusted (Primary Analysis Model): includes terms of Treatment, Week, Baseline, Fasting Plasma Glucose, Center, and Type of Diabetes.||14.817|-11.16|
72463271|NCT00139659|144448869|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.149|STANDARD_ERROR_OF_MEAN|7.991||||90.0|-12.01|14.307|||Mixed Models Analysis|||Week 52; Analysis of change from Baseline in fasting plasma glucose: Inhaled Insulin - Subcutaneouas Insulin. Adjusted (Primary Analysis Model): includes terms of Treatment, Week, Baseline, Fasting Plasma Glucose, Center, and Type of Diabetes.||14.307|-12.01|
72563820|NCT04100096|144659009|SUPERIORITY||Mean Difference (Final Values)|0.09||||0.067|TWO_SIDED|95.0|-0.01|0.19||ANCOVA model, with treatment as main effect and baseline value as covariate, is used for change from baseline of case comparisons.|ANCOVA|||Week 12||0.19|-0.01|0.0670
72393403|NCT03975790|144294189|SUPERIORITY|||||||0.4384|||||||Chi-squared|||Other bone disease/musculoskeletal deformities||||0.4384
72393404|NCT03975790|144294189|SUPERIORITY|||||||0.6082|||||||Chi-squared|||Malaise/fatigue||||0.6082
72393405|NCT03975790|144294189|SUPERIORITY|||||||0.3374|||||||Chi-squared|||Malaise/fatigue||||0.3374
72393406|NCT03975790|144294189|SUPERIORITY|||||||0.5984|||||||Chi-squared|||Malaise/fatigue||||0.5984
72393407|NCT03975790|144294189|SUPERIORITY|||||||0.8568|||||||Chi-squared|||Esophageal disorders||||0.8568
72393408|NCT03975790|144294189|SUPERIORITY|||||||0.7698|||||||Chi-squared|||Esophageal disorders||||0.7698
72393409|NCT03975790|144294189|SUPERIORITY|||||||0.7089|||||||Chi-squared|||Esophageal disorders||||0.7089
72393410|NCT03975790|144294189|SUPERIORITY|||||||0.3446|||||||Chi-squared|||Nutritional deficiencies||||0.3446
72393411|NCT03975790|144294189|SUPERIORITY|||||||0.0815|||||||Chi-squared|||Nutritional deficiencies||||0.0815
72393412|NCT03975790|144294189|SUPERIORITY|||||||0.402|||||||Chi-squared|||Nutritional deficiencies||||0.4020
72393413|NCT03975790|144294189|SUPERIORITY|||||||0.4246|||||||Chi-squared|||Other nutritional: endocrine/metabolic disorders||||0.4246
72393414|NCT03975790|144294189|SUPERIORITY|||||||0.8118|||||||Chi-squared|||Other nutritional: endocrine/metabolic disorders||||0.8118
72393415|NCT03975790|144294189|SUPERIORITY|||||||0.7454|||||||Chi-squared|||Other nutritional: endocrine/metabolic disorders||||0.7454
72393416|NCT03975790|144294189|SUPERIORITY|||||||0.3559|||||||Chi-squared|||Diabetes mellitus without complication||||0.3559
72393417|NCT03975790|144294189|SUPERIORITY|||||||0.7698|||||||Chi-squared|||Diabetes mellitus without complication||||0.7698
72463272|NCT00139659|144448869|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.247|STANDARD_ERROR_OF_MEAN|7.816||||90.0|-8.664|17.157|||Mixed Models Analysis|||Week 52 (LOCF); Analysis of change from Baseline in fasting plasma glucose: Inhaled Insulin - Subcutaneouas Insulin. Adjusted (Primary Analysis Model): includes terms of Treatment, Week, Baseline, Fasting Plasma Glucose, Center, and Type of Diabetes.||17.157|-8.664|
72463273|NCT00139659|144448870|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.08|STANDARD_ERROR_OF_MEAN|0.455||||90.0|-1.829|-0.331|||Mixed Models Analysis|||Week 1; adjusted mean difference between inhaled insulin and subcutaneous insulin groups. Primary analysis model includes terms of Treatment, Week, Baseline Body Weight, Center, and Type of Diabetes.||-0.331|-1.829|
72463274|NCT00139659|144448870|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.475|STANDARD_ERROR_OF_MEAN|0.461||||90.0|-1.233|0.284|||Mixed Models Analysis|||Week 2; adjusted mean difference between inhaled insulin and subcutaneous insulin groups. Primary analysis model includes terms of Treatment, Week, Baseline Body Weight, Center, and Type of Diabetes.||0.284|-1.233|
72463275|NCT00139659|144448870|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.185|STANDARD_ERROR_OF_MEAN|0.454||||90.0|-0.931|0.562|||Mixed Models Analysis|||Week 3; adjusted mean difference between inhaled insulin and subcutaneous insulin groups. Primary analysis model includes terms of Treatment, Week, Baseline Body Weight, Center, and Type of Diabetes.||0.562|-0.931|
72463276|NCT00139659|144448870|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.189|STANDARD_ERROR_OF_MEAN|0.449||||90.0|-0.929|0.55|||Mixed Models Analysis|||Week 4; adjusted mean difference between inhaled insulin and subcutaneous insulin groups. Primary analysis model includes terms of Treatment, Week, Baseline Body Weight, Center, and Type of Diabetes.||0.550|-0.929|
72463277|NCT00139659|144448870|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.558|STANDARD_ERROR_OF_MEAN|0.447||||90.0|-1.294|0.178|||Mixed Models Analysis|||Week 6; adjusted mean difference between inhaled insulin and subcutaneous insulin groups. Primary analysis model includes terms of Treatment, Week, Baseline Body Weight, Center, and Type of Diabetes.||0.178|-1.294|
72463278|NCT00139659|144448870|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.748|STANDARD_ERROR_OF_MEAN|0.467||||90.0|-1.517|0.022|||Mixed Models Analysis|||Week 9; adjusted mean difference between inhaled insulin and subcutaneous insulin groups. Primary analysis model includes terms of Treatment, Week, Baseline Body Weight, Center, and Type of Diabetes.||0.022|-1.517|
72463279|NCT00139659|144448870|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.053|STANDARD_ERROR_OF_MEAN|0.886||||90.0|-2.51|0.405|||Mixed Models Analysis|||Week 11; adjusted mean difference between inhaled insulin and subcutaneous insulin groups. Primary analysis model includes terms of Treatment, Week, Baseline Body Weight, Center, and Type of Diabetes.||0.405|-2.510|
72463280|NCT00139659|144448870|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.891|STANDARD_ERROR_OF_MEAN|0.451||||90.0|-1.634|-0.149|||Mixed Models Analysis|||Week 12; adjusted mean difference between inhaled insulin and subcutaneous insulin groups. Primary analysis model includes terms of Treatment, Week, Baseline Body Weight, Center, and Type of Diabetes.||-0.149|-1.634|
72463281|NCT00139659|144448870|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.98|STANDARD_ERROR_OF_MEAN|0.453||||90.0|-1.725|-0.234|||Mixed Models Analysis|||Week 18; adjusted mean difference between inhaled insulin and subcutaneous insulin groups. Primary analysis model includes terms of Treatment, Week, Baseline Body Weight, Center, and Type of Diabetes.||-0.234|-1.725|
72463282|NCT00139659|144448870|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.663|STANDARD_ERROR_OF_MEAN|0.448||||90.0|-1.4|0.075|||Mixed Models Analysis|||Week 26; adjusted mean difference between inhaled insulin and subcutaneous insulin groups. Primary analysis model includes terms of Treatment, Week, Baseline Body Weight, Center, and Type of Diabetes.||0.075|-1.400|
72393418|NCT03975790|144294189|SUPERIORITY|||||||0.7323|||||||Chi-squared|||Diabetes mellitus without complication||||0.7323
72393419|NCT03975790|144294189|SUPERIORITY|||||||0.5935|||||||Chi-squared|||Other/unspecified benign neoplasm||||0.5935
72393420|NCT03975790|144294189|SUPERIORITY|||||||0.3928|||||||Chi-squared|||Other/unspecified benign neoplasm||||0.3928
72393421|NCT03975790|144294189|SUPERIORITY|||||||0.7089|||||||Chi-squared|||Other/unspecified benign neoplasm||||0.7089
72393422|NCT03975790|144294189|SUPERIORITY|||||||0.8746|||||||Chi-squared|||Other upper respiratory disease||||0.8746
72393423|NCT03975790|144294189|SUPERIORITY|||||||0.3835|||||||Chi-squared|||Other upper respiratory disease||||0.3835
72393424|NCT03975790|144294189|SUPERIORITY|||||||0.4992|||||||Chi-squared|||Other upper respiratory disease||||0.4992
72393425|NCT03975790|144294190|SUPERIORITY|||||||0.2336|||||||t-test|||||||0.2336
72563821|NCT02322788|144659016|SUPERIORITY_OR_OTHER||Estimated mean ratio|1.87|||<|0.001|TWO_SIDED|95.0|1.52|2.29|||Mixed Models Analysis|||A linear mixed effect model based on restricted maximum likelihood analysis is used to estimate the treatment effect. PC20 in natural log scale is the response variable, treatment and period are the fixed effects, and patient within sequence is a random effect.||2.29|1.52|<0.001
72563822|NCT02322788|144659016|SUPERIORITY_OR_OTHER||Estimated mean ratio|1.79|||<|0.001|TWO_SIDED|95.0|1.46|2.2|||Mixed Models Analysis|||A linear mixed effect model based on restricted maximum likelihood analysis is used to estimate the treatment effect. PC20 in natural log scale is the response variable, treatment and period are the fixed effects, and patient within sequence is a random effect.||2.20|1.46|<0.001
72393426|NCT03975790|144294190|SUPERIORITY|||||||0.2109|||||||t-test|||||||0.2109
72393427|NCT03975790|144294190|SUPERIORITY|||||||0.0691|||||||t-test|||||||0.0691
72393428|NCT03975790|144294191|SUPERIORITY|||||||0.9758|||||||Chi-squared|||MTX Sodium||||0.9758
72393429|NCT03975790|144294191|SUPERIORITY|||||||0.9978|||||||Chi-squared|||MTX Sodium||||0.9978
72393430|NCT03975790|144294191|SUPERIORITY|||||||0.9861|||||||Chi-squared|||MTX Sodium||||0.9861
72393431|NCT03975790|144294191|SUPERIORITY|||||||0.5744|||||||Chi-squared|||Folic Acid||||0.5744
72393432|NCT03975790|144294191|SUPERIORITY|||||||0.8542|||||||Chi-squared|||Folic Acid||||0.8542
72393433|NCT03975790|144294191|SUPERIORITY|||||||0.8363|||||||Chi-squared|||Folic Acid||||0.8363
72393434|NCT03975790|144294191|SUPERIORITY|||||||0.0473|||||||Chi-squared|||Prednisone||||0.0473
72393435|NCT03975790|144294191|SUPERIORITY|||||||0.0327|||||||Chi-squared|||Prednisone||||0.0327
72393436|NCT03975790|144294191|SUPERIORITY|||||||0.5348|||||||Chi-squared|||Prednisone||||0.5348
72393437|NCT03975790|144294191|SUPERIORITY|||||||0.6934|||||||Chi-squared|||Acetaminophen/Hydrocodone Bitartrate||||0.6934
72393438|NCT03975790|144294191|SUPERIORITY|||||||0.6017|||||||Chi-squared|||Acetaminophen/Hydrocodone Bitartrate||||0.6017
72393439|NCT03975790|144294191|SUPERIORITY|||||||0.4768|||||||Chi-squared|||Acetaminophen/Hydrocodone Bitartrate||||0.4768
72393440|NCT03975790|144294191|SUPERIORITY|||||||0.2315|||||||Chi-squared|||Azithromycin||||0.2315
72393441|NCT03975790|144294191|SUPERIORITY|||||||0.2588|||||||Chi-squared|||Azithromycin||||0.2588
72393442|NCT03975790|144294191|SUPERIORITY|||||||0.8576|||||||Chi-squared|||Azithromycin||||0.8576
72393443|NCT03975790|144294191|SUPERIORITY|||||||0.5909|||||||Chi-squared|||Adalimumab||||0.5909
72393444|NCT03975790|144294191|SUPERIORITY|||||||0.057|||||||Chi-squared|||Adalimumab||||0.0570
72393445|NCT03975790|144294191|SUPERIORITY|||||||0.0408|||||||Chi-squared|||Adalimumab||||0.0408
72393446|NCT03975790|144294191|SUPERIORITY|||||||0.6465|||||||Chi-squared|||Hydroxychloroquine Sulfate||||0.6465
72393447|NCT03975790|144294191|SUPERIORITY|||||||0.5654|||||||Chi-squared|||Hydroxychloroquine Sulfate||||0.5654
72393448|NCT03975790|144294191|SUPERIORITY|||||||0.8371|||||||Chi-squared|||Hydroxychloroquine Sulfate||||0.8371
72393449|NCT03975790|144294191|SUPERIORITY|||||||0.9654|||||||Chi-squared|||Etanercept||||0.9654
72393450|NCT03975790|144294191|SUPERIORITY|||||||0.1013|||||||Chi-squared|||Etanercept||||0.1013
72393451|NCT03975790|144294191|SUPERIORITY|||||||0.158|||||||Chi-squared|||Etanercept||||0.1580
72393452|NCT03975790|144294191|SUPERIORITY|||||||0.1663|||||||Chi-squared|||Levothyroxine Sodium||||0.1663
72393453|NCT03975790|144294191|SUPERIORITY|||||||0.6563|||||||Chi-squared|||Levothyroxine Sodium||||0.6563
72393454|NCT03975790|144294191|SUPERIORITY|||||||0.5785|||||||Chi-squared|||Levothyroxine Sodium||||0.5785
72393455|NCT03975790|144294191|SUPERIORITY|||||||0.4166|||||||Chi-squared|||Methylprednisolone||||0.4166
72393456|NCT03975790|144294191|SUPERIORITY|||||||0.0636|||||||Chi-squared|||Methylprednisolone||||0.0636
72393457|NCT03975790|144294191|SUPERIORITY|||||||0.3137|||||||Chi-squared|||Methylprednisolone||||0.3137
72393458|NCT03975790|144294191|SUPERIORITY|||||||0.4568|||||||Chi-squared|||Omeprazole||||0.4568
72393459|NCT03975790|144294191|SUPERIORITY|||||||0.5785|||||||Chi-squared|||Omeprazole||||0.5785
72393460|NCT03975790|144294191|SUPERIORITY|||||||0.9541|||||||Chi-squared|||Omeprazole||||0.9541
72393461|NCT03975790|144294191|SUPERIORITY|||||||0.1956|||||||Chi-squared|||Tramadol Hydrochloride||||0.1956
72393462|NCT03975790|144294191|SUPERIORITY|||||||0.3633|||||||Chi-squared|||Tramadol Hydrochloride||||0.3633
72393463|NCT03975790|144294191|SUPERIORITY|||||||0.9481|||||||Chi-squared|||Tramadol Hydrochloride||||0.9481
72393464|NCT03975790|144294191|SUPERIORITY|||||||0.3653|||||||Chi-squared|||Meloxicam||||0.3653
72393465|NCT03975790|144294191|SUPERIORITY|||||||0.9255|||||||Chi-squared|||Meloxicam||||0.9255
72393466|NCT03975790|144294191|SUPERIORITY|||||||0.5137|||||||Chi-squared|||Meloxicam||||0.5137
72393467|NCT03975790|144294191|SUPERIORITY|||||||0.6338|||||||Chi-squared|||Amoxicillin||||0.6338
72393468|NCT03975790|144294191|SUPERIORITY|||||||0.6329|||||||Chi-squared|||Amoxicillin||||0.6329
72393469|NCT03975790|144294191|SUPERIORITY|||||||0.9228|||||||Chi-squared|||Amoxicillin||||0.9228
72393470|NCT03975790|144294191|SUPERIORITY|||||||0.8433|||||||Chi-squared|||Albuterol Sulfate||||0.8433
72393471|NCT03975790|144294191|SUPERIORITY|||||||0.1175|||||||Chi-squared|||Albuterol Sulfate||||0.1175
72393472|NCT03975790|144294191|SUPERIORITY|||||||0.1215|||||||Chi-squared|||Albuterol Sulfate||||0.1215
72393473|NCT03975790|144294191|SUPERIORITY|||||||0.9007|||||||Chi-squared|||Gabapentin||||0.9007
72393474|NCT03975790|144294191|SUPERIORITY|||||||0.8789|||||||Chi-squared|||Gabapentin||||0.8789
72393475|NCT03975790|144294191|SUPERIORITY|||||||0.8305|||||||Chi-squared|||Gabapentin||||0.8305
72393476|NCT03975790|144294191|SUPERIORITY|||||||0.0694|||||||Chi-squared|||Acetaminophen/Oxycodone Hydrochloride||||0.0694
72393477|NCT03975790|144294191|SUPERIORITY|||||||0.8606|||||||Chi-squared|||Acetaminophen/Oxycodone Hydrochloride||||0.8606
72393478|NCT03975790|144294191|SUPERIORITY|||||||0.3363|||||||Chi-squared|||Acetaminophen/Oxycodone Hydrochloride||||0.3363
72393479|NCT03975790|144294191|SUPERIORITY|||||||0.3319|||||||Chi-squared|||Amoxicillin/Clavulanate Potassium||||0.3319
72393480|NCT03975790|144294191|SUPERIORITY|||||||0.5615|||||||Chi-squared|||Amoxicillin/Clavulanate Potassium||||0.5615
72393481|NCT03975790|144294191|SUPERIORITY|||||||0.8898|||||||Chi-squared|||Amoxicillin/Clavulanate Potassium||||0.8898
72393482|NCT03975790|144294191|SUPERIORITY|||||||0.367|||||||Chi-squared|||Cyclobenzaprine Hydrochloride||||0.3670
72393483|NCT03975790|144294191|SUPERIORITY|||||||0.8155|||||||Chi-squared|||Cyclobenzaprine Hydrochloride||||0.8155
72463283|NCT00139659|144448870|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.537|STANDARD_ERROR_OF_MEAN|0.451||||90.0|-1.279|0.205|||Mixed Models Analysis|||Week 39; adjusted mean difference between inhaled insulin and subcutaneous insulin groups. Primary analysis model includes terms of Treatment, Week, Baseline Body Weight, Center, and Type of Diabetes.||0.205|-1.279|
72393484|NCT03975790|144294191|SUPERIORITY|||||||0.7091|||||||Chi-squared|||Cyclobenzaprine Hydrochloride||||0.7091
72463284|NCT00139659|144448870|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.322|STANDARD_ERROR_OF_MEAN|1.027||||90.0|-3.012|0.369|||Mixed Models Analysis|||Week 50; adjusted mean difference between inhaled insulin and subcutaneous insulin groups. Primary analysis model includes terms of Treatment, Week, Baseline Body Weight, Center, and Type of Diabetes.||0.369|-3.012|
72463285|NCT00139659|144448870|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.063|STANDARD_ERROR_OF_MEAN|0.552||||90.0|-0.847|0.972|||Mixed Models Analysis|||Week 51; adjusted mean difference between inhaled insulin and subcutaneous insulin groups. Primary analysis model includes terms of Treatment, Week, Baseline Body Weight, Center, and Type of Diabetes.||0.972|-0.847|
72463286|NCT00139659|144448870|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.193|STANDARD_ERROR_OF_MEAN|0.469||||90.0|-0.964|0.579|||Mixed Models Analysis|||Week 52; adjusted mean difference between inhaled insulin and subcutaneous insulin groups. Primary analysis model includes terms of Treatment, Week, Baseline Body Weight, Center, and Type of Diabetes.||0.579|-0.964|
72463287|NCT00139659|144448870|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.43|STANDARD_ERROR_OF_MEAN|0.526||||90.0|-1.298|0.438|||Mixed Models Analysis|||Week 52 (LOCF); adjusted mean difference between inhaled insulin and subcutaneous insulin groups. Primary analysis model includes terms of Treatment, Week, Baseline Body Weight, Center, and Type of Diabetes.||0.438|-1.298|
72463288|NCT00139659|144448878|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.039|STANDARD_ERROR_OF_MEAN|0.024||||90.0|-0.079|0.0|||Mixed Models Analysis|||Week 1; Inhaled Insulin - Subcutaneous Insulin. Adjusted (primary analysis model) includes terms of Treatment, Week, Baseline pulmonary function test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||-0.000|-0.079|
72463289|NCT00139659|144448878|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.029|STANDARD_ERROR_OF_MEAN|0.024||||90.0|-0.068|0.01|||Mixed Models Analysis|||Week 2; Inhaled Insulin - Subcutaneous Insulin. Adjusted (primary analysis model) includes terms of Treatment, Week, Baseline pulmonary function test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||0.010|-0.068|
72463290|NCT00139659|144448878|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.045|STANDARD_ERROR_OF_MEAN|0.024||||90.0|-0.084|-0.006|||Mixed Models Analysis|||Week 3; Inhaled Insulin - Subcutaneous Insulin. Adjusted (primary analysis model) includes terms of Treatment, Week, Baseline pulmonary function test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||-0.006|-0.084|
72463291|NCT00139659|144448878|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.046|STANDARD_ERROR_OF_MEAN|0.024||||90.0|-0.085|-0.007|||Mixed Models Analysis|||Week 4; Inhaled Insulin - Subcutaneous Insulin. Adjusted (primary analysis model) includes terms of Treatment, Week, Baseline pulmonary function test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||-0.007|-0.085|
72463292|NCT00139659|144448878|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.046|STANDARD_ERROR_OF_MEAN|0.024||||90.0|-0.085|-0.007|||Mixed Models Analysis|||Week 6; Inhaled Insulin - Subcutaneous Insulin. Adjusted (primary analysis model) includes terms of Treatment, Week, Baseline pulmonary function test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||-0.007|-0.085|
72463293|NCT00139659|144448878|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.023|STANDARD_ERROR_OF_MEAN|0.024||||90.0|-0.063|0.017|||Mixed Models Analysis|||Week 12; Inhaled Insulin - Subcutaneous Insulin. Adjusted (primary analysis model) includes terms of Treatment, Week, Baseline pulmonary function test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||0.017|-0.063|
72463294|NCT00139659|144448878|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.021|STANDARD_ERROR_OF_MEAN|0.025||||90.0|-0.062|0.02|||Mixed Models Analysis|||Week 18; Inhaled Insulin - Subcutaneous Insulin. Adjusted (primary analysis model) includes terms of Treatment, Week, Baseline pulmonary function test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||0.020|-0.062|
72463295|NCT00139659|144448878|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.014|STANDARD_ERROR_OF_MEAN|0.025||||90.0|-0.055|0.027|||Mixed Models Analysis|||Week 26; Inhaled Insulin - Subcutaneous Insulin. Adjusted (primary analysis model) includes terms of Treatment, Week, Baseline pulmonary function test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||0.027|-0.055|
72463296|NCT00139659|144448878|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.042|STANDARD_ERROR_OF_MEAN|0.026||||90.0|-0.085|0.0|||Mixed Models Analysis|||Week 39; Inhaled Insulin - Subcutaneous Insulin. Adjusted (primary analysis model) includes terms of Treatment, Week, Baseline pulmonary function test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||0.000|-0.085|
72463297|NCT00139659|144448878|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.065|STANDARD_ERROR_OF_MEAN|0.027||||90.0|-0.109|-0.022|||Mixed Models Analysis|||Week 52; Inhaled Insulin - Subcutaneous Insulin. Adjusted (primary analysis model) includes terms of Treatment, Week, Baseline pulmonary function test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||-0.022|-0.109|
72621159|NCT02732145|144773181|SUPERIORITY|Question: Is there a difference in the incidence of vulvar stinging versus aching in the patients with vulvodynia?||||||0.0005|||||||t-test proportion|||Parameter: The difference in the incidence of vulvar stinging versus aching in patients with vulvodynia.||||0.0005
72621160|NCT02732145|144773181|SUPERIORITY|Question: Is there a difference in the incidence of vulvar itching versus burning in the patients with vulvodynia?||||||0|||||||t-test proportion|||Parameter: The difference in the incidence of vulvar itching versus burning in patients with vulvodynia.||||0.0000
72393485|NCT03975790|144294191|SUPERIORITY|||||||0.9769|||||||Chi-squared|||Fluticasone Propionate||||0.9769
72393486|NCT03975790|144294191|SUPERIORITY|||||||0.5032|||||||Chi-squared|||Fluticasone Propionate||||0.5032
72393487|NCT03975790|144294191|SUPERIORITY|||||||0.5631|||||||Chi-squared|||Fluticasone Propionate||||0.5631
72393488|NCT03975790|144294191|SUPERIORITY|||||||0.4426|||||||Chi-squared|||Ciprofloxacin Hydrochloride||||0.4426
72393489|NCT03975790|144294191|SUPERIORITY|||||||0.5734|||||||Chi-squared|||Ciprofloxacin Hydrochloride||||0.5734
72393490|NCT03975790|144294191|SUPERIORITY|||||||0.3071|||||||Chi-squared|||Ciprofloxacin Hydrochloride||||0.3071
72393491|NCT03975790|144294191|SUPERIORITY|||||||0.1608|||||||Chi-squared|||Duloxetine Hydrochloride||||0.1608
72563823|NCT02322788|144659016|NON_INFERIORITY_OR_EQUIVALENCE|The details of the sample size calculation is document at Section 8.2 the study protocol.|Estimated mean ratio|0.92|||||TWO_SIDED|95.0|0.75|1.13|||Mixed Models Analysis|||A linear mixed effect model based on restricted maximum likelihood analysis is used to estimate the treatment effect. PC20 in natural log scale is the response variable, treatment and period are the fixed effects, and patient within sequence is a random effect.||1.13|0.75|
72563824|NCT02322788|144659016|NON_INFERIORITY_OR_EQUIVALENCE|The details of the sample size calculation is document at Section 8.2 the study protocol.|Estimated mean ratio|0.88|||||TWO_SIDED|95.0|0.72|1.08|||Mixed Models Analysis|||A linear mixed effect model based on restricted maximum likelihood analysis is used to estimate the treatment effect. PC20 in natural log scale is the response variable, treatment and period are the fixed effects, and patient within sequence is a random effect.||1.08|0.72|
72393492|NCT03975790|144294191|SUPERIORITY|||||||0.4092|||||||Chi-squared|||Duloxetine Hydrochloride||||0.4092
72463298|NCT00139659|144448878|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.028||||90.0|-0.097|-0.003|||Mixed Models Analysis|||Week 52 Last Observation Carried Forward (LOCF; Inhaled Insulin - Subcutaneous Insulin. Adjusted (primary analysis model) includes terms of Treatment, Week, Baseline pulmonary function test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||-0.003|-0.097|
72463299|NCT00139659|144448879|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.279|STANDARD_ERROR_OF_MEAN|0.199||||90.0|-0.606|0.048|||Mixed Models Analysis|||Week 1; Inhaled Insulin - Subcutaneous Insulin. Adjusted (primary analysis model) includes terms of Treatment, Week, Baseline pulmonary function test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||0.048|-0.606|
72463300|NCT00139659|144448879|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.336|STANDARD_ERROR_OF_MEAN|0.198||||90.0|-0.661|-0.011|||Mixed Models Analysis|||Week 2; Inhaled Insulin - Subcutaneous Insulin. Adjusted (primary analysis model) includes terms of Treatment, Week, Baseline pulmonary function test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||-0.011|-0.661|
72463301|NCT00139659|144448879|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.384|STANDARD_ERROR_OF_MEAN|0.196||||90.0|-0.707|-0.061|||Mixed Models Analysis|||Week 3; Inhaled Insulin - Subcutaneous Insulin. Adjusted (primary analysis model) includes terms of Treatment, Week, Baseline pulmonary function test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||-0.061|-0.707|
72502078|NCT01212445|144534207|SUPERIORITY_OR_OTHER||Treatment Success Rate|0.196||||0.2558|TWO_SIDED|95.0|0.098|0.331|||Fisher Exact|||The treatment success rate was calculated as the number of participants in a treatment group with treatment successes (BM with no straining or hard/lumpy stools) divided by the total number of participants in the treatment group. Treatment success rate was calculated for each dose group along with 95% confidence intervals (CI) based on exact binomial statistics. Treatment success rates were compared between each pair of treatments using an exact 2-sided test (Fisher's).||0.331|0.098|0.2558
72502079|NCT01212445|144534207|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.92|||||TWO_SIDED|95.0|0.774|4.763|||Regression, Logistic|||"Logistic regression analysis was performed with treatment success as the dichotomous dependent variable and dose (13.125g, 26.25g, or 39.375 g) as the independent variable. The main effects for the model were tested for significance at the 5% level.~The odds of response for the 26.25 g dose level versus the 13.125 g dose level were presented together with the associated 95% confidence interval. There were no multiplicity adjustments."||4.763|0.774|
72563825|NCT02760264|144659020|OTHER|Treatment levels were not compared.|||||||||||||||||"Safety Population was used for this analysis. Safety Population includes all subjects who receive at least one dose of vamorolone study medication.~Treatment levels were not compared."|||
72393493|NCT03975790|144294191|SUPERIORITY|||||||0.1215|||||||Chi-squared|||Duloxetine Hydrochloride||||0.1215
72393494|NCT03975790|144294191|SUPERIORITY|||||||0.7279|||||||Chi-squared|||Atorvastatin Calcium||||0.7279
72393495|NCT03975790|144294191|SUPERIORITY|||||||0.7703|||||||Chi-squared|||Atorvastatin Calcium||||0.7703
72393496|NCT03975790|144294191|SUPERIORITY|||||||0.6254|||||||Chi-squared|||Atorvastatin Calcium||||0.6254
72502080|NCT01212445|144534207|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.024|||||TWO_SIDED|95.0|0.386|2.72|||Regression, Logistic|||"Logistic regression analysis was performed with treatment success as the dichotomous dependent variable and dose (13.125g, 26.25g, or 39.375 g) as the independent variable. The main effects for the model were tested for significance at the 5% level.~The odds of response for the 39.375 g dose level versus the 13.125 g dose level were presented together with the associated 95% confidence intervals. There were no multiplicity adjustments."||2.720|0.386|
72502081|NCT01212445|144534209|SUPERIORITY_OR_OTHER||Treatment Success Rate|0.077||||0.235|TWO_SIDED|95.0|0.021|0.185|||Fisher Exact|||The treatment success rate was calculated as the number of participants in a treatment group with treatment successes (BM with no straining or hard/lumpy stools) divided by the total number of participants in the treatment group. Treatment success rate was calculated for each dose group along with 95% confidence intervals (CI) based on exact binomial statistics. Treatment success rates were compared between each pair of treatments using an exact 2-sided test (Fisher's).||0.185|0.021|0.2350
72393497|NCT03975790|144294191|SUPERIORITY|||||||0.1615|||||||Chi-squared|||Diclofenac Sodium||||0.1615
72393498|NCT03975790|144294191|SUPERIORITY|||||||0.505|||||||Chi-squared|||Diclofenac Sodium||||0.5050
72393499|NCT03975790|144294191|SUPERIORITY|||||||0.1592|||||||Chi-squared|||Diclofenac Sodium||||0.1592
72393500|NCT03975790|144294191|SUPERIORITY|||||||0.6088|||||||Chi-squared|||Levofloxacin||||0.6088
72393501|NCT03975790|144294191|SUPERIORITY|||||||0.4713|||||||Chi-squared|||Levofloxacin||||0.4713
72393502|NCT03975790|144294191|SUPERIORITY|||||||0.3399|||||||Chi-squared|||Levofloxacin||||0.3399
72463302|NCT00139659|144448879|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.516|STANDARD_ERROR_OF_MEAN|0.198||||90.0|-0.842|-0.191|||Mixed Models Analysis|||Week 4; Inhaled Insulin - Subcutaneous Insulin. Adjusted (primary analysis model) includes terms of Treatment, Week, Baseline pulmonary function test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||-0.191|-0.842|
72463303|NCT00139659|144448879|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.474|STANDARD_ERROR_OF_MEAN|0.196||||90.0|-0.797|-0.152|||Mixed Models Analysis|||Week 6; Inhaled Insulin - Subcutaneous Insulin. Adjusted (primary analysis model) includes terms of Treatment, Week, Baseline pulmonary function test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||-0.152|-0.797|
72463304|NCT00139659|144448879|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.533|STANDARD_ERROR_OF_MEAN|0.202||||90.0|-0.866|-0.2|||Mixed Models Analysis|||Week 12; Inhaled Insulin - Subcutaneous Insulin. Adjusted (primary analysis model) includes terms of Treatment, Week, Baseline pulmonary function test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||-0.200|-0.866|
72463305|NCT00139659|144448879|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.509|STANDARD_ERROR_OF_MEAN|0.204||||90.0|-0.845|-0.174|||Mixed Models Analysis|||Week 18; Inhaled Insulin - Subcutaneous Insulin. Adjusted (primary analysis model) includes terms of Treatment, Week, Baseline pulmonary function test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||-0.174|-0.845|
72463306|NCT00139659|144448879|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.412|STANDARD_ERROR_OF_MEAN|0.204||||90.0|-0.749|-0.076|||Mixed Models Analysis|||Week 26; Inhaled Insulin - Subcutaneous Insulin. Adjusted (primary analysis model) includes terms of Treatment, Week, Baseline pulmonary function test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||-0.076|-0.749|
72463307|NCT00139659|144448879|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.707|STANDARD_ERROR_OF_MEAN|0.212||||90.0|-1.056|-0.358|||Mixed Models Analysis|||Week 39; Inhaled Insulin - Subcutaneous Insulin. Adjusted (primary analysis model) includes terms of Treatment, Week, Baseline pulmonary function test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||-0.358|-1.056|
72463308|NCT00139659|144448879|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.68|STANDARD_ERROR_OF_MEAN|0.219||||90.0|-1.04|-0.32|||Mixed Models Analysis|||Week 52; Inhaled Insulin - Subcutaneous Insulin. Adjusted (primary analysis model) includes terms of Treatment, Week, Baseline pulmonary function test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||-0.320|-1.040|
72463309|NCT00139659|144448879|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.765|STANDARD_ERROR_OF_MEAN|0.212||||90.0|-1.116|-0.415|||Mixed Models Analysis|||Week 52 Last Observation Carried Forward (LOCF); Inhaled Insulin - Subcutaneous Insulin. Adjusted (primary analysis model) includes terms of Treatment, Week, Baseline pulmonary function test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||-0.415|-1.116|
72463310|NCT02391116|144448888|OTHER||Percentage Difference|2.2|||||TWO_SIDED|90.0|-28.7|32.9|||Exact confidence intervals (CI)||ORR difference in FAS (N=54): ORR in CD79b mutant subgroup minus ORR in CD79b wild-type subgroup|||32.9|-28.7|
72463311|NCT02391116|144448888|OTHER||Percentage Difference|0.0|||||TWO_SIDED|90.0|-33.5|33.5|||Exact confidence intervals (CI)||ORR difference in PPS (N=40): ORR in CD79b mutant subgroup minus ORR in CD79b wild-type subgroup|||33.5|-33.5|
72502082|NCT01212445|144534209|SUPERIORITY_OR_OTHER||Treatment Success Rate|0.157||||0.5256|TWO_SIDED|95.0|0.07|0.286|||Fisher Exact|||The treatment success rate was calculated as the number of participants in a treatment group with treatment successes (BM with no straining or hard/lumpy stools) divided by the total number of participants in the treatment group. Treatment success rate was calculated for each dose group along with 95% confidence intervals (CI) based on exact binomial statistics. Treatment success rates were compared between each pair of treatments using an exact 2-sided test (Fisher's).||0.286|0.070|0.5256
72463312|NCT02391116|144448889|OTHER||Percentage Difference|16.4|||||TWO_SIDED|90.0|-7.2|39.1|||Exact confidence intervals (CI)||ORR difference in FAS (N=52): ORR in ABC subgroup minus ORR in non-ABC group (i.e. combined GCB subgroup and Unclassifiable subgroup)|||39.1|-7.2|
72463313|NCT02391116|144448889|OTHER||Percentage Difference|20.8|||||TWO_SIDED|90.0|-6.8|46.2|||Exact confidence intervals (CI)||ORR difference in PPS (N=40): ORR in ABC subgroup minus ORR in non-ABC group (i.e. combined GCB subgroup and Unclassifiable subgroup)|||46.2|-6.8|
72463314|NCT02391116|144448889|OTHER||Percentage Difference|-18.5|||||TWO_SIDED|90.0|-40.1|4.6|||Exact confidence intervals (CI)||ORR difference in FAS (N=52): ORR in GCB subgroup minus ORR in non-GCB subgroup (i.e. combined ABC subgroup and Unclassifiable subgroup)|||4.6|-40.1|
72463315|NCT02391116|144448889|OTHER||Percentage Difference|-25.3|||||TWO_SIDED|90.0|-49.1|1.1|||Exact confidence intervals (CI)||ORR difference in PPS (N=40): ORR in GCB subgroup minus ORR in non-GCB subgroup (i.e. combined ABC subgroup and Unclassifiable subgroup)|||1.1|-49.1|
72463316|NCT02391116|144448889|OTHER||Percentage Difference|12.9|||||TWO_SIDED|90.0|-42.4|63.2|||Exact confidence intervals (CI)||ORR difference in FAS (N=52): ORR in Unclassifiable subgroup minus ORR in ABC / GCB subgroup (i.e. combined ABC subgroup and GCB subgroup)|||63.2|-42.4|
72502083|NCT01212445|144534209|SUPERIORITY_OR_OTHER||Treatment Success Rate|0.118||||0.7746|TWO_SIDED|95.0|0.044|0.239|||Fisher Exact|||The treatment success rate was calculated as the number of participants in a treatment group with treatment successes (BM with no straining or hard/lumpy stools) divided by the total number of participants in the treatment group. Treatment success rate was calculated for each dose group along with 95% confidence intervals (CI) based on exact binomial statistics. Treatment success rates were compared between each pair of treatments using an exact 2-sided test (Fisher's).||0.239|0.044|0.7746
72463317|NCT02391116|144448889|OTHER||Percentage Difference|26.3|||||TWO_SIDED|90.0|-44.3|77.6|||Exact confidence intervals (CI)||ORR difference in PPS (N=40): ORR in Unclassifiable subgroup minus ORR in ABC / GCB subgroup (i.e. combined ABC subgroup and GCB subgroup)|||77.6|-44.3|
72463318|NCT01747629|144448917|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.92|STANDARD_ERROR_OF_MEAN|0.163|<|0.0001|TWO_SIDED|95.0|0.59|1.24||Significance at the 0.05 level.|mixed-model repeated-measures (MMRM)|Fixed effects- pooled center, treatment group, study day, and study day by drug interaction, with baseline measured at each study day as covariate.||||1.24|0.59|<0.0001
72463319|NCT01747629|144448918|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.05|STANDARD_ERROR_OF_MEAN|0.249|<|0.0001|TWO_SIDED|95.0|0.56|1.55||To adjust for multiplicity, so that the overall alpha level for all tests was controlled at the 0.05 level, tests were done sequentially \[day 1, then day 8, then day 85\] and terminated if individual results were not significant at the 0.05 level.|mixed model repeated measures (MMRM)|Fixed effects- pooled center, treatment group, study day, and study day by drug interaction, with baseline measured at each study day as covariate.||||1.55|0.56|<0.0001
72502084|NCT01212445|144534209|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.233|||||TWO_SIDED|95.0|0.628|7.94|||Regression, Logistic|||"Logistic regression analysis was performed with treatment success as the dichotomous dependent variable and dose (13.125g, 26.25g, or 39.375 g) as the independent variable. The main effects for the model were tested for significance at the 5% level.~The odds of response for the 26.25 g dose level versus the 13.125 g dose level were presented together with the associated 95% confidence intervals. There were no multiplicity adjustments."||7.940|0.628|
72563826|NCT02760264|144659022|OTHER|Treatment levels were not compared.|||||||||||||||||"Safety Population was used for this analysis. Safety Population includes all subjects who receive at least one dose of vamorolone study medication.~Treatment levels were not compared."|||
72393503|NCT03975790|144294192|SUPERIORITY|||||||0.2349|||||||Chi-squared|||MTX Sodium||||0.2349
72393504|NCT03975790|144294192|SUPERIORITY|||||||0.3956|||||||Chi-squared|||MTX Sodium||||0.3956
72393505|NCT03975790|144294192|SUPERIORITY|||||||0.55|||||||Chi-squared|||Folic Acid||||0.5500
72393506|NCT03975790|144294192|SUPERIORITY|||||||0.7131|||||||Chi-squared|||Folic Acid||||0.7131
72393507|NCT03975790|144294192|SUPERIORITY|||||||0.942|||||||Chi-squared|||Folic Acid||||0.9420
72393508|NCT03975790|144294192|SUPERIORITY|||||||0.0571|||||||Chi-squared|||Prednisone||||0.0571
72393509|NCT03975790|144294192|SUPERIORITY|||||||0.049|||||||Chi-squared|||Prednisone||||0.0490
72393510|NCT03975790|144294192|SUPERIORITY|||||||0.5631|||||||Chi-squared|||Prednisone||||0.5631
72393511|NCT03975790|144294192|SUPERIORITY|||||||0.2198|||||||Chi-squared|||Acetaminophen/Hydrocodone Bitartrate||||0.2198
72393512|NCT03975790|144294192|SUPERIORITY|||||||0.385|||||||Chi-squared|||Acetaminophen/Hydrocodone Bitartrate||||0.3850
72393513|NCT03975790|144294192|SUPERIORITY|||||||0.1165|||||||Chi-squared|||Acetaminophen/Hydrocodone Bitartrate||||0.1165
72393514|NCT03975790|144294192|SUPERIORITY|||||||0.4291|||||||Chi-squared|||Azithromycin||||0.4291
72393515|NCT03975790|144294192|SUPERIORITY|||||||0.385|||||||Chi-squared|||Azithromycin||||0.3850
72393516|NCT03975790|144294192|SUPERIORITY|||||||0.8143|||||||Chi-squared|||Azithromycin||||0.8143
72393517|NCT03975790|144294192|SUPERIORITY|||||||0.7272|||||||Chi-squared|||Adalimumab||||0.7272
72393518|NCT03975790|144294192|SUPERIORITY|||||||0.0501|||||||Chi-squared|||Adalimumab||||0.0501
72393519|NCT03975790|144294192|SUPERIORITY|||||||0.05|||||||Chi-squared|||Adalimumab||||0.0500
72563827|NCT02760264|144659024|OTHER|Treatment levels were not compared.|||||||||||||||||"Safety Population was used for this analysis. Safety Population includes all subjects who receive at least one dose of vamorolone study medication.~Treatment levels were not compared."|||
72563828|NCT02760264|144659025|OTHER|Treatment levels were not compared.|||||||||||||||||"Safety Population was used for this analysis. Safety Population includes all subjects who receive at least one dose of vamorolone study medication.~Treatment levels were not compared."|||
72393520|NCT03975790|144294192|SUPERIORITY|||||||0.3116|||||||Chi-squared|||Hydroxychloroquine Sulfate||||0.3116
72393521|NCT03975790|144294192|SUPERIORITY|||||||0.4882|||||||Chi-squared|||Hydroxychloroquine Sulfate||||0.4882
72393522|NCT03975790|144294192|SUPERIORITY|||||||0.9505|||||||Chi-squared|||Hydroxychloroquine Sulfate||||0.9505
72393523|NCT03975790|144294192|SUPERIORITY|||||||0.408|||||||Chi-squared|||Etanercept||||0.4080
72393524|NCT03975790|144294192|SUPERIORITY|||||||0.7644|||||||Chi-squared|||Etanercept||||0.7644
72393525|NCT03975790|144294192|SUPERIORITY|||||||0.4146|||||||Chi-squared|||Etanercept||||0.4146
72393526|NCT03975790|144294192|SUPERIORITY|||||||0.1348|||||||Chi-squared|||Levothyroxine Sodium||||0.1348
72393527|NCT03975790|144294192|SUPERIORITY|||||||0.5948|||||||Chi-squared|||Levothyroxine Sodium||||0.5948
72393528|NCT03975790|144294192|SUPERIORITY|||||||0.5785|||||||Chi-squared|||Levothyroxine Sodium||||0.5785
72393529|NCT03975790|144294192|SUPERIORITY|||||||0.1033|||||||Chi-squared|||Methylprednisolone||||0.1033
72393530|NCT03975790|144294192|SUPERIORITY|||||||0.2117|||||||Chi-squared|||Methylprednisolone||||0.2117
72393531|NCT03975790|144294192|SUPERIORITY|||||||0.992|||||||Chi-squared|||Methylprednisolone||||0.9920
72393532|NCT03975790|144294192|SUPERIORITY|||||||0.9212|||||||Chi-squared|||Omeprazole||||0.9212
72393533|NCT03975790|144294192|SUPERIORITY|||||||0.9212|||||||Chi-squared|||Omeprazole||||0.9212
72393534|NCT03975790|144294192|SUPERIORITY|||||||0.4384|||||||Chi-squared|||Omeprazole||||0.4384
72393535|NCT03975790|144294192|SUPERIORITY|||||||0.0162|||||||Chi-squared|||Tramadol Hydrochloride||||0.0162
72393536|NCT03975790|144294192|SUPERIORITY|||||||0.3239|||||||Chi-squared|||Tramadol Hydrochloride||||0.3239
72393537|NCT03975790|144294192|SUPERIORITY|||||||0.4837|||||||Chi-squared|||Tramadol Hydrochloride||||0.4837
72393538|NCT03975790|144294192|SUPERIORITY|||||||0.7183|||||||Chi-squared|||Meloxicam||||0.7183
72393539|NCT03975790|144294192|SUPERIORITY|||||||0.2667|||||||Chi-squared|||Meloxicam||||0.2667
72393540|NCT03975790|144294192|SUPERIORITY|||||||0.451|||||||Chi-squared|||Meloxicam||||0.4510
72393541|NCT03975790|144294192|SUPERIORITY|||||||0.7993|||||||Chi-squared|||Amoxicillin||||0.7993
72393542|NCT03975790|144294192|SUPERIORITY|||||||0.9896|||||||Chi-squared|||Amoxicillin||||0.9896
72393543|NCT03975790|144294192|SUPERIORITY|||||||0.8576|||||||Chi-squared|||Amoxicillin||||0.8576
72393544|NCT03975790|144294192|SUPERIORITY|||||||0.9373|||||||Chi-squared|||Albuterol Sulfate||||0.9373
72393545|NCT03975790|144294192|SUPERIORITY|||||||0.1253|||||||Chi-squared|||Albuterol Sulfate||||0.1253
72393546|NCT03975790|144294192|SUPERIORITY|||||||0.1851|||||||Chi-squared|||Albuterol Sulfate||||0.1851
72393547|NCT03975790|144294192|SUPERIORITY|||||||0.8697|||||||Chi-squared|||Gabapentin||||0.8697
72393548|NCT03975790|144294192|SUPERIORITY|||||||0.9719|||||||Chi-squared|||Gabapentin||||0.9719
72393549|NCT03975790|144294192|SUPERIORITY|||||||0.938|||||||Chi-squared|||Gabapentin||||0.9380
72393550|NCT03975790|144294192|SUPERIORITY|||||||0.1079|||||||Chi-squared|||Acetaminophen/Oxycodone Hydrochloride||||0.1079
72393551|NCT03975790|144294192|SUPERIORITY|||||||0.2588|||||||Chi-squared|||Acetaminophen/Oxycodone Hydrochloride||||0.2588
72393552|NCT03975790|144294192|SUPERIORITY|||||||0.9358|||||||Chi-squared|||Acetaminophen/Oxycodone Hydrochloride||||0.9358
72393553|NCT03975790|144294192|SUPERIORITY|||||||0.1984|||||||Chi-squared|||Amoxicillin/Clavulanate Potassium||||0.1984
72393554|NCT03975790|144294192|SUPERIORITY|||||||0.8542|||||||Chi-squared|||Amoxicillin/Clavulanate Potassium||||0.8542
72393555|NCT03975790|144294192|SUPERIORITY|||||||0.2973|||||||Chi-squared|||Amoxicillin/Clavulanate Potassium||||0.2973
72502085|NCT01212445|144534209|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.6|||||TWO_SIDED|95.0|0.424|6.043|||Regression, Logistic|||"Logistic regression analysis was performed with treatment success as the dichotomous dependent variable and dose (13.125g, 26.25g, or 39.375 g) as the independent variable. The main effects for the model were tested for significance at the 5% level.~The odds of response for the 39.375 g dose level versus the 13.125 g dose level were presented together with the associated 95% confidence intervals. There were no multiplicity adjustments."||6.043|0.424|
72393556|NCT03975790|144294192|SUPERIORITY|||||||0.1046|||||||Chi-squared|||Cyclobenzaprine Hydrochloride||||0.1046
72393557|NCT03975790|144294192|SUPERIORITY|||||||0.7961|||||||Chi-squared|||Cyclobenzaprine Hydrochloride||||0.7961
72393558|NCT03975790|144294192|SUPERIORITY|||||||0.214|||||||Chi-squared|||Cyclobenzaprine Hydrochloride||||0.2140
72393559|NCT03975790|144294192|SUPERIORITY|||||||0.8578|||||||Chi-squared|||Fluticasone Propionate||||0.8578
72393560|NCT03975790|144294192|SUPERIORITY|||||||0.7131|||||||Chi-squared|||Fluticasone Propionate||||0.7131
72393561|NCT03975790|144294192|SUPERIORITY|||||||0.8421|||||||Chi-squared|||Fluticasone Propionate||||0.8421
72393562|NCT03975790|144294192|SUPERIORITY|||||||0.7637|||||||Chi-squared|||Ciprofloxacin Hydrochloride||||0.7637
72393563|NCT03975790|144294192|SUPERIORITY|||||||0.6355|||||||Chi-squared|||Ciprofloxacin Hydrochloride||||0.6355
72393564|NCT03975790|144294192|SUPERIORITY|||||||0.5425|||||||Chi-squared|||Ciprofloxacin Hydrochloride||||0.5425
72393565|NCT03975790|144294192|SUPERIORITY|||||||0.041|||||||Chi-squared|||Duloxetine Hydrochloride||||0.0410
72393566|NCT03975790|144294192|SUPERIORITY|||||||0.8251|||||||Chi-squared|||Duloxetine Hydrochloride||||0.8251
72393567|NCT03975790|144294192|SUPERIORITY|||||||0.2871|||||||Chi-squared|||Duloxetine Hydrochloride||||0.2871
72393568|NCT03975790|144294192|SUPERIORITY|||||||0.1174|||||||Chi-squared|||Diclofenac Sodium||||0.1174
72393569|NCT03975790|144294192|SUPERIORITY|||||||0.9702|||||||Chi-squared|||Diclofenac Sodium||||0.9702
72393570|NCT03975790|144294192|SUPERIORITY|||||||0.3109|||||||Chi-squared|||Diclofenac Sodium||||0.3109
72393571|NCT03975790|144294192|SUPERIORITY|||||||0.6744|||||||Chi-squared|||Levofloxacin||||0.6744
72393572|NCT03975790|144294192|SUPERIORITY|||||||0.8121|||||||Chi-squared|||Levofloxacin||||0.8121
72393573|NCT03975790|144294192|SUPERIORITY|||||||0.9451|||||||Chi-squared|||Levofloxacin||||0.9451
72393574|NCT03975790|144294192|SUPERIORITY|||||||0.166|||||||Chi-squared|||Cephalexin||||0.1660
72393575|NCT03975790|144294192|SUPERIORITY|||||||0.9549|||||||Chi-squared|||Cephalexin||||0.9549
72393576|NCT03975790|144294192|SUPERIORITY|||||||0.3104|||||||Chi-squared|||Cephalexin||||0.3104
72393577|NCT03975790|144294192|SUPERIORITY|||||||0.0489|||||||Chi-squared|||Ibuprofen||||0.0489
72393578|NCT03975790|144294192|SUPERIORITY|||||||0.1515|||||||Chi-squared|||Ibuprofen||||0.1515
72393579|NCT03975790|144294192|SUPERIORITY|||||||0.9481|||||||Chi-squared|||Ibuprofen||||0.9481
72393580|NCT03975790|144294193|SUPERIORITY|||||||0.2178|||||||Chi-squared|||||||0.2178
72393581|NCT03975790|144294193|SUPERIORITY|||||||0.5237|||||||Chi-squared|||||||0.5237
72393582|NCT03975790|144294193|SUPERIORITY|||||||0.7964|||||||Chi-squared|||||||0.7964
72393583|NCT03975790|144294194|SUPERIORITY|||||||0.9085|||||||Chi-squared|||||||0.9085
72393584|NCT03975790|144294194|SUPERIORITY|||||||0.6283|||||||Chi-squared|||||||0.6283
72393585|NCT03975790|144294194|SUPERIORITY|||||||0.7293|||||||Chi-squared|||||||0.7293
72393586|NCT03975790|144294195|SUPERIORITY|||||||0.9392|||||||Chi-squared|||||||0.9392
72393587|NCT03975790|144294195|SUPERIORITY|||||||0.3063|||||||Chi-squared|||||||0.3063
72393588|NCT03975790|144294195|SUPERIORITY|||||||0.3467|||||||Chi-squared|||||||0.3467
72393589|NCT03975790|144294196|SUPERIORITY|||||||0.7977|||||||Chi-squared|||||||0.7977
72393590|NCT03975790|144294196|SUPERIORITY|||||||0.5241|||||||Chi-squared|||||||0.5241
72393591|NCT03975790|144294196|SUPERIORITY|||||||0.4702|||||||Chi-squared|||||||0.4702
72393592|NCT03975790|144294197|SUPERIORITY|||||||0.1461|||||||t-test|||||||0.1461
72502086|NCT01212445|144534210|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.752||||0.1876|TWO_SIDED|95.0|-3.834|19.338|||ANCOVA|||||19.338|-3.834|0.1876
72502087|NCT01212445|144534210|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.706||||0.768|TWO_SIDED|95.0|-9.729|13.141|||ANCOVA|||||13.141|-9.729|0.7680
72502088|NCT01212445|144534210|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.046||||0.2941|TWO_SIDED|95.0|-17.412|5.32|||ANCOVA|||||5.320|-17.412|0.2941
72502089|NCT01212445|144534211|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.302||||0.8109|TWO_SIDED|95.0|-12.059|9.454|||ANCOVA|||||9.454|-12.059|0.8109
72393593|NCT03975790|144294197|SUPERIORITY|||||||0.1411|||||||t-test|||||||0.1411
72393594|NCT03975790|144294197|SUPERIORITY|||||||0.4201|||||||t-test|||||||0.4201
72393595|NCT03975790|144294198|SUPERIORITY|||||||0.3955|||||||t-test|||||||0.3955
72393596|NCT03975790|144294198|SUPERIORITY|||||||0.6356|||||||t-test|||||||0.6356
72393597|NCT03975790|144294198|SUPERIORITY|||||||0.3833|||||||t-test|||||||0.3833
72393598|NCT03975790|144294199|SUPERIORITY|||||||0.3292|||||||t-test|||||||0.3292
72393599|NCT03975790|144294199|SUPERIORITY|||||||0.2959|||||||t-test|||||||0.2959
72393600|NCT03975790|144294199|SUPERIORITY|||||||0.6962|||||||t-test|||||||0.6962
72393601|NCT03975790|144294200|SUPERIORITY|||||||0.8138|||||||t-test|||||||0.8138
72393602|NCT03975790|144294200|SUPERIORITY|||||||0.007|||||||t-test|||||||0.0070
72393603|NCT03975790|144294200|SUPERIORITY|||||||0.0358|||||||t-test|||||||0.0358
72393604|NCT03975790|144294201|SUPERIORITY|||||||0.8453|||||||t-test|||||||0.8453
72393605|NCT03975790|144294201|SUPERIORITY|||||||0.4806|||||||t-test|||||||0.4806
72393606|NCT03975790|144294201|SUPERIORITY|||||||0.4809|||||||t-test|||||||0.4809
72393607|NCT03975790|144294202|SUPERIORITY|||||||0.3076|||||||t-test|||||||0.3076
72393608|NCT03975790|144294202|SUPERIORITY|||||||0.2509|||||||t-test|||||||0.2509
72393609|NCT03975790|144294202|SUPERIORITY|||||||0.7827|||||||t-test|||||||0.7827
72393610|NCT03975790|144294203|SUPERIORITY|||||||0.4261|||||||Chi-squared|||During Persistency||||0.4261
72393611|NCT03975790|144294203|SUPERIORITY|||||||0.5247|||||||Chi-squared|||During Persistency||||0.5247
72393612|NCT03975790|144294203|SUPERIORITY|||||||0.2809|||||||Chi-squared|||During Persistency||||0.2809
72393613|NCT03975790|144294203|SUPERIORITY|||||||0.1153|||||||Chi-squared|||Post Persistency||||0.1153
72393614|NCT03975790|144294203|SUPERIORITY|||||||0.1344|||||||Chi-squared|||Post Persistency||||0.1344
72463320|NCT01747629|144448919|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.77|STANDARD_ERROR_OF_MEAN|0.212||0.0004|TWO_SIDED|95.0|0.35|1.19||To adjust for multiplicity, so that the overall alpha level for all tests was controlled at the 0.05 level, tests were done sequentially \[day 1, then day 8, then day 85\] and terminated if individual results were not significant at the 0.05 level.|mixed model repeated measures (MMRM)|Fixed effects- pooled center, treatment group, study day, and study day by drug interaction, with baseline measured at each study day as covariate.||||1.19|0.35|0.0004
72463321|NCT01747629|144448920|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.93|STANDARD_ERROR_OF_MEAN|0.18|<|0.0001|TWO_SIDED|95.0|0.57|1.28||To adjust for multiplicity, so that the overall alpha level for all tests was controlled at the 0.05 level, tests were done sequentially \[day 1, then day 8, then day 85\] and terminated if individual results were not significant at the 0.05 level.|mixed model repeated measures (MMRM)|Fixed effects- pooled center, treatment group, study day, and study day by drug interaction, with baseline measured at each study day as covariate.||||1.28|0.57|<0.0001
72621161|NCT02732145|144773181|SUPERIORITY|Question: Is there a difference in the incidence of vulvar itching versus soreness in the patients with vulvodynia?||||||0.1201|||||||t-test proportion|||Parameter: The difference in the incidence of vulvar itching versus soreness in patients with vulvodynia.||||0.1201
72463322|NCT04414397|144448931|SUPERIORITY||Rate Difference|66.9|||<|0.0001|TWO_SIDED|95.0|54.9|78.8||Analysis was performed using the SAS procedure MIANALYZE with normal approximation to generate an associated p-value for the comparison of responder rates between groups.|Multiple imputation regression|||JUVÉDERM® VOLUMA® XC Treatment vs No-treatment control||78.8|54.9|<0.0001
72463323|NCT04414397|144448935|OTHER||||||<|0.0001||||||P-value is based on a 2-sided paired t-test at the 5% level to demonstrate that the mean satisfaction score at Month 3 visit is statistically greater than at Baseline for the treatment group.|t-test, 2 sided|||||||<0.0001
72463324|NCT04414397|144448936|OTHER||||||<|0.0001||||||P-value is based on a 2-sided paired t-test at the 5% level to demonstrate that the mean satisfaction score at Month 3 is statistically greater than at Baseline for the treatment group.|t-test, 2 sided|||||||<0.0001
72463325|NCT04754594|144448981|OTHER||Geometric mean ratio|0.67|||||TWO_SIDED|95.0|0.5|0.9||||||GMRs and 2-sided 95% CIs was calculated by exponentiating the mean difference of the logarithms of the assay and the corresponding CIs.||0.90|0.50|
72463326|NCT04754594|144448982|OTHER||Geometric mean ratio|1.27|||||TWO_SIDED|95.0|0.91|1.77||||||GMRs and 2-sided 95% CIs was calculated by exponentiating the mean difference of the logarithms of the assay and the corresponding CIs.||1.77|0.91|
72463327|NCT04754594|144448982|OTHER||Geometric mean ratio|0.95|||||TWO_SIDED|95.0|0.69|1.3||||||GMRs and 2-sided 95% CIs was calculated by exponentiating the mean difference of the logarithms of the assay and the corresponding CIs.||1.30|0.69|
72463328|NCT04754594|144448983|OTHER|Vaccine efficacy was estimated by 100\*(1 - illness rate ratio \[IRR\]), where IRR=calculated ratio of confirmed COVID-19 illness per 1000 person-years of blinded follow-up in the active vaccine group to the corresponding illness rate in the placebo group.|Vaccine efficacy|3.8|||||TWO_SIDED|95.0|-1227.8|93.0||||||||93.0|-1227.8|
72393615|NCT03975790|144294203|SUPERIORITY|||||||0.8229|||||||Chi-squared|||Post Persistency||||0.8229
72393616|NCT03975790|144294204|SUPERIORITY|||||||0.7816|||||||Chi-squared|||During Persistency||||0.7816
72393617|NCT03975790|144294204|SUPERIORITY|||||||0.7124|||||||Chi-squared|||During Persistency||||0.7124
72463329|NCT04754594|144448984|OTHER|Vaccine efficacy was estimated by 100\*(1 - IRR), where IRR=calculated ratio of confirmed COVID-19 illness per 1000 person-years of blinded follow-up in the active vaccine group to the corresponding illness rate in the placebo group.|Vaccine efficacy|35.1|||||TWO_SIDED|95.0|-466.5|94.6||||||||94.6|-466.5|
72463330|NCT04754594|144448985|OTHER|Vaccine efficacy was estimated by 100\*(1 - IRR), where IRR=calculated ratio of confirmed COVID-19 illness per 1000 person-years of blinded follow-up in the active vaccine group to the corresponding illness rate in the placebo group.|Vaccine efficacy|40.9|||||TWO_SIDED|95.0|-104.9|86.5||||||||86.5|-104.9|
72463331|NCT02799745|144449042|SUPERIORITY||Hazard Ratio (HR)|0.542||||0.016|TWO_SIDED|95.0|0.33|0.892||P-value was from a 2-sided stratified log-rank test.|Log Rank||HR, 95% CI for HR:based on a Cox regression model assuming proportional hazards with treatment, prostate cancer risk,type of biopsy,baseline variables(as age, race), time since prostate cancer diagnosis as fixed effects and random effect of site.|||0.892|0.330|0.016
72463332|NCT02799745|144449044|SUPERIORITY||Odds Ratio (OR)|3.5||||0|TWO_SIDED|95.0|1.76|6.92||P-value: Based on the exact binomial distribution from the logistic regression model.|Regression, Logistic||OR: from logistic regression model where fixed covariates=treatment group, prostate cancer risk, type of biopsy, age, race and time since prostate cancer diagnosis; random effects: site and subject. 95% CI: based on exact binomial distribution.|At the end of month 12||6.92|1.76|0.00
72463333|NCT02799745|144449044|SUPERIORITY||Odds Ratio (OR)|1.6||||0.289|TWO_SIDED|95.0|0.66|4.0||P-value: Based on the exact binomial distribution from the logistic regression model.|Regression, Logistic||OR: from logistic regression model where fixed covariates=treatment group, prostate cancer risk, type of biopsy, age, race and time since prostate cancer diagnosis; random effects: site and subject. 95% CI: based on exact binomial distribution.|At the end of month 24||4.00|0.66|0.289
72502090|NCT01212445|144534211|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.075||||0.6995|TWO_SIDED|95.0|-12.693|8.544|||ANCOVA|||||8.544|-12.693|0.6995
72502091|NCT01212445|144534211|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.772||||0.885|TWO_SIDED|95.0|-11.329|9.784|||ANCOVA|||||9.784|-11.329|0.8850
72502092|NCT01212445|144534212|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.886||||0.0486|TWO_SIDED|95.0|0.078|25.695|||ANCOVA|||||25.695|0.078|0.0486
72502093|NCT01212445|144534212|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.245||||0.8465|TWO_SIDED|95.0|-11.471|13.962|||ANCOVA|||||13.962|-11.471|0.8465
72502094|NCT01212445|144534212|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.641||||0.0744|TWO_SIDED|95.0|-24.449|1.167|||ANCOVA|||||1.167|-24.449|0.0744
72502095|NCT01212445|144534213|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.69||||0.4591|TWO_SIDED|95.0|-6.153|13.534|||ANCOVA|||||13.534|-6.153|0.4591
72502096|NCT01212445|144534213|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.887||||0.5546|TWO_SIDED|95.0|-6.765|12.539|||ANCOVA|||||12.539|-6.765|0.5546
72502097|NCT01212445|144534213|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.803||||0.8685|TWO_SIDED|95.0|-10.397|8.79|||ANCOVA|||||8.790|-10.397|0.8685
72393618|NCT03975790|144294204|SUPERIORITY|||||||0.6148|||||||Chi-squared|||During Persistency||||0.6148
72393619|NCT03975790|144294204|SUPERIORITY|||||||0.4876|||||||Chi-squared|||Post Persistency||||0.4876
72393620|NCT03975790|144294204|SUPERIORITY|||||||0.7826|||||||Chi-squared|||Post Persistency||||0.7826
72393621|NCT03975790|144294204|SUPERIORITY|||||||0.8337|||||||Chi-squared|||Post Persistency||||0.8337
72393622|NCT03975790|144294205|SUPERIORITY|||||||0.1344|||||||Chi-squared|||||||0.1344
72393623|NCT03975790|144294205|SUPERIORITY|||||||0.0095|||||||Chi-squared|||||||0.0095
72502098|NCT01212445|144534214|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.311||||0.1865|TWO_SIDED|95.0|-0.774|0.152|||ANCOVA|||||0.152|-0.774|0.1865
72393624|NCT03975790|144294205|SUPERIORITY|||||||0.1406|||||||Chi-squared|||||||0.1406
72393625|NCT03975790|144294206|SUPERIORITY|||||||0.9379|||||||Chi-squared|||||||0.9379
72502099|NCT01212445|144534214|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.139||||0.553|TWO_SIDED|95.0|-0.602|0.323|||ANCOVA|||||0.323|-0.602|0.5530
72393626|NCT03975790|144294206|SUPERIORITY|||||||0.3025|||||||Chi-squared|||||||0.3025
72393627|NCT03975790|144294206|SUPERIORITY|||||||0.3388|||||||Chi-squared|||||||0.3388
72393628|NCT03975790|144294207|SUPERIORITY|||||||0.8205|||||||t-test|||||||0.8205
72393629|NCT03975790|144294207|SUPERIORITY|||||||0.0467|||||||t-test|||||||0.0467
72393630|NCT03975790|144294207|SUPERIORITY|||||||0.1083|||||||t-test|||||||0.1083
72393631|NCT03975790|144294208|SUPERIORITY|||||||0.8899|||||||t-test|||||||0.8899
72393632|NCT03975790|144294208|SUPERIORITY|||||||0.6183|||||||t-test|||||||0.6183
72502100|NCT01212445|144534214|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.172||||0.467|TWO_SIDED|95.0|-0.293|0.637|||ANCOVA|||||0.637|-0.293|0.4670
72502101|NCT03972488|144534218|SUPERIORITY||Hazard Ratio (HR)|0.276|||<|0.0001|TWO_SIDED|95.0|0.182|0.418|||Log Rank|Stratified one-sided P-value||||0.418|0.182|<0.0001
72502102|NCT03972488|144534219|SUPERIORITY||Stratified Odds Ratio|7.81|||<|0.0001|TWO_SIDED|95.0|3.32|18.4|||Stratified One-sided p-value|||||18.40|3.32|<0.0001
72502103|NCT03972488|144534220|SUPERIORITY||Hazard Ratio (HR)|0.856||||0.2222|TWO_SIDED|95.0|0.57|1.283|||Log Rank|Stratified one-sided P-value||Global Health Status||1.283|0.570|0.2222
72502104|NCT02770807|144534227|SUPERIORITY||Least squares mean difference|-1.37||||0.0847|TWO_SIDED|95.0|-2.932|0.19|||Mixed model for repeated measures|||Least squares means, and p-values are derived from a mixed model repeated measures analysis with baseline modified ICARS value as covariate and the fixed effects of treatment, age, sex, region and visit and the interaction term treatment-by-visit.||0.190|-2.932|0.0847
72563829|NCT02760264|144659027|OTHER|Treatment levels were not compared.|||||||||||||||||"Safety Population was used for this analysis. Safety Population includes all subjects who receive at least one dose of vamorolone study medication.~Treatment levels were not compared."|||
72393633|NCT03975790|144294208|SUPERIORITY|||||||0.6496|||||||t-test|||||||0.6496
72393634|NCT03975790|144294209|SUPERIORITY|||||||0.5027|||||||t-test|||||||0.5027
72393635|NCT03975790|144294209|SUPERIORITY|||||||0.2375|||||||t-test|||||||0.2375
72393636|NCT03975790|144294209|SUPERIORITY|||||||0.5577|||||||t-test|||||||0.5577
72393637|NCT03975790|144294210|SUPERIORITY|||||||0.6908|||||||t-test|||||||0.6908
72393638|NCT03975790|144294210|SUPERIORITY|||||||0.0859|||||||t-test|||||||0.0859
72393639|NCT03975790|144294210|SUPERIORITY|||||||0.2764|||||||t-test|||||||0.2764
72393640|NCT03975790|144294211|SUPERIORITY|||||||0.1906|||||||t-test|||||||0.1906
72393641|NCT03975790|144294211|SUPERIORITY|||||||0.8744|||||||t-test|||||||0.8744
72393642|NCT03975790|144294211|SUPERIORITY|||||||0.3295|||||||t-test|||||||0.3295
72393643|NCT03975790|144294212|SUPERIORITY|||||||0.0056|||||||t-test|||All cause||||0.0056
72393644|NCT03975790|144294212|SUPERIORITY|||||||0.4222|||||||t-test|||All cause||||0.4222
72393645|NCT03975790|144294212|SUPERIORITY|||||||0.0041|||||||t-test|||All cause||||0.0041
72393646|NCT03975790|144294212|SUPERIORITY|||||||0.2277|||||||t-test|||RA related||||0.2277
72393647|NCT03975790|144294212|SUPERIORITY|||||||0.2812|||||||t-test|||RA related||||0.2812
72393648|NCT03975790|144294212|SUPERIORITY|||||||0.0772|||||||t-test|||RA related||||0.0772
72393649|NCT03975790|144294213|SUPERIORITY|||||||0.293|||||||t-test|||All cause||||0.2930
72393650|NCT03975790|144294213|SUPERIORITY|||||||0.439|||||||t-test|||All cause||||0.4390
72393651|NCT03975790|144294213|SUPERIORITY|||||||0.153|||||||t-test|||All cause||||0.1530
72393652|NCT03975790|144294213|SUPERIORITY|||||||0.9439|||||||t-test|||RA related||||0.9439
72393653|NCT03975790|144294213|SUPERIORITY|||||||0.4477|||||||t-test|||RA related||||0.4477
72393654|NCT03975790|144294213|SUPERIORITY|||||||0.4519|||||||t-test|||RA related||||0.4519
72393655|NCT03975790|144294214|SUPERIORITY|||||||0.9829|||||||Chi-squared|||Cardiovascular Disease||||0.9829
72393656|NCT03975790|144294214|SUPERIORITY|||||||0.8021|||||||Chi-squared|||Cardiovascular Disease||||0.8021
72393657|NCT03975790|144294214|SUPERIORITY|||||||0.8376|||||||Chi-squared|||Cardiovascular Disease||||0.8376
72393658|NCT03975790|144294214|SUPERIORITY|||||||0.5927|||||||Chi-squared|||COPD||||0.5927
72393659|NCT03975790|144294214|SUPERIORITY|||||||0.5202|||||||Chi-squared|||COPD||||0.5202
72393660|NCT03975790|144294214|SUPERIORITY|||||||0.8517|||||||Chi-squared|||COPD||||0.8517
72393661|NCT03975790|144294214|SUPERIORITY|||||||8.33|||||||Chi-squared|||Asthma||||8.33
72393662|NCT03975790|144294214|SUPERIORITY|||||||0.7483|||||||Chi-squared|||Asthma||||0.7483
72393663|NCT03975790|144294214|SUPERIORITY|||||||0.9713|||||||Chi-squared|||Asthma||||0.9713
72393664|NCT03975790|144294214|SUPERIORITY|||||||0.9148|||||||Chi-squared|||Kidney disease||||0.9148
72393665|NCT03975790|144294214|SUPERIORITY|||||||0.7248|||||||Chi-squared|||Kidney disease||||0.7248
72393666|NCT03975790|144294214|SUPERIORITY|||||||0.82|||||||Chi-squared|||Kidney disease||||0.8200
72393667|NCT03975790|144294214|SUPERIORITY|||||||0.9657|||||||Chi-squared|||Diabetes||||0.9657
72393668|NCT03975790|144294214|SUPERIORITY|||||||0.9255|||||||Chi-squared|||Diabetes||||0.9255
72393669|NCT03975790|144294214|SUPERIORITY|||||||0.9575|||||||Chi-squared|||Diabetes||||0.9575
72393670|NCT03975790|144294214|SUPERIORITY|||||||0.941|||||||Chi-squared|||Depression||||0.9410
72393671|NCT03975790|144294214|SUPERIORITY|||||||0.9146|||||||Chi-squared|||Depression||||0.9146
72393672|NCT03975790|144294214|SUPERIORITY|||||||0.9641|||||||Chi-squared|||Depression||||0.9641
72393673|NCT03975790|144294214|SUPERIORITY|||||||0.2596|||||||Chi-squared|||Anxiety||||0.2596
72621162|NCT02732145|144773181|SUPERIORITY|Question: Is there a difference in the incidence of vulvar itching versus irritation in the patients with vulvodynia?||||||0.0123|||||||t-test proportion|||Parameter: The difference in the incidence of vulvar itching versus irritation in patients with vulvodynia.||||0.0123
72463334|NCT02799745|144449045|SUPERIORITY||LS mean difference|-10.07|STANDARD_ERROR_OF_MEAN|2.398|<|0.001|TWO_SIDED|95.0|-14.79|-5.34||P-values: from differences of least squares means.Bonferroni-Holm was used in the primary hypothesis testing to adjust for multiplicity.|Mixed Models Analysis|Compound symmetry was used as the covariance structure. Covariance parameters:estimated using Restricted Maximum likelihood.|Mixed model repeated measure(MMRM) with treatment group, prostate cancer risk(low/intermediate), type of biopsy(mpMRI-targeted/non-mpMRI-targeted), visit, visit-by-treatment, baseline scores as fixed factors, site and participants as random factors.|Change at month 12||-5.34|-14.79|<0.001
72463335|NCT02799745|144449045|SUPERIORITY||LS mean difference|-5.15|STANDARD_ERROR_OF_MEAN|3.174||0.1063|TWO_SIDED|95.0|-11.4|1.11||P-values: from differences of least squares means.Bonferroni-Holm was used in the primary hypothesis testing to adjust for multiplicity.|Mixed Models Analysis|Compound symmetry was used as the covariance structure. Covariance parameters:estimated using Restricted Maximum likelihood.|MMRM with treatment group, prostate cancer risk (low vs. intermediate), type of biopsy (mpMRI targeted vs. non mpMRI targeted), visit, visit-by-treatment and baseline scores were the fixed factors, and site and participants were the random factors.|Change at month 24||1.11|-11.40|0.1063
72463336|NCT02799745|144449046|SUPERIORITY||Hazard Ratio (HR)|0.714||||0.032|TWO_SIDED|95.0|0.525|0.972||P-value: from a 2-sided, stratified log-rank test.|Log Rank||HR and 95% CI for HR:based on Cox regression model assuming proportional hazards with treatment, prostate cancer risk, type of biopsy, baseline variables(as age, race), time since prostate cancer diagnosis as fixed effects and random effect of site.|||0.972|0.525|0.032
72463337|NCT02799745|144449047|SUPERIORITY||Odds Ratio (OR)|0.1||||0|TWO_SIDED|95.0|0.08|0.26||P-value:based on the exact binomial distribution from the logistic regression model.|Regression, Logistic||OR:from logistic regression model where treatment group, prostate cancer risk, type of biopsy, age, race and time since prostate cancer diagnosis were fixed covariates, site and participant were random effects. 95% CI:based on binomial distribution.|At the end of month 12||0.26|0.08|0.000
72463338|NCT02799745|144449047|SUPERIORITY||Odds Ratio (OR)|1.1||||0.807|TWO_SIDED|95.0|0.37|3.53||P-value: based on the exact binomial distribution from the logistic regression model.|Regression, Logistic||OR: from logistic regression model where treatment group, prostate cancer risk, type of biopsy, age, race and time since prostate cancer diagnosis were fixed covariates, site and participant were random effects. 95% CI:based on binomial distribution.|At the end of month 24||3.53|0.37|0.807
72463339|NCT02799745|144449047|SUPERIORITY||Odds Ratio (OR)|1.0||||0.931|TWO_SIDED|95.0|0.5|2.15||P-value:based on the exact binomial distribution from the logistic regression model.|Regression, Logistic||OR: from logistic regression model where treatment group, prostate cancer risk, type of biopsy, age, race and time since prostate cancer diagnosis were fixed covariates, site and participant were random effects. 95% CI:based on binomial distribution.|At the end of study||2.15|0.50|0.931
72463340|NCT00088452|144449080|SUPERIORITY||Odds Ratio (OR)|2.66|||<|0.001|TWO_SIDED|95.0|1.65|4.28|||Chi-squared||odds ratio with ethosuximide vs. lamotrigine|Calculations of sample size were based on the ability to detect a 20% difference in freedom-from failure rates (three pairwise comparisons) at 16 weeks with 80% power at a two-sided P value of 0.017 and one interim analysis. Sample size of 398 was increased to 446 subjects to account for two stratification factors and a 5% dropout rate; this sample size allowed the detection of a difference of 0.5 SD in the Confidence Index on the Conners' Continuous Performance Test with a power exceeding 80%.||4.28|1.65|<0.001
72463341|NCT00088452|144449080|SUPERIORITY||Odds Ratio (OR)|3.34|||<|0.001|TWO_SIDED|95.0|2.06|5.42|||Chi-squared||odds ratio with valproic acid vs. lamotrigine|Calculations of sample size were based on the ability to detect a 20% difference in freedom-from failure rates (three pairwise comparisons) at 16 weeks with 80% power at a two-sided P value of 0.017 and one interim analysis. Sample size of 398 was increased to 446 subjects to account for two stratification factors and a 5% dropout rate; this sample size allowed the detection of a difference of 0.5 SD in the Confidence Index on the Conners' Continuous Performance Test with a power exceeding 80%.||5.42|2.06|<0.001
72463342|NCT00088452|144449081|SUPERIORITY||Odds Ratio (OR)|1.95||||0.03|TWO_SIDED|95.0|1.12|3.41|||Chi-squared||Percentage of subjects with a Confidence Index score of 0.60 or higher in the valproic acid group than in the ethosuximide group|||3.41|1.12|0.03
72463343|NCT00088452|144449081|SUPERIORITY||Odds Ratio (OR)|3.04|||<|0.001|TWO_SIDED|95.0|1.69|5.49|||Chi-squared||Percentage of subjects with a Confidence Index score of 0.60 or higher in the valproic acid group than in the lamotrigine group|||5.49|1.69|<0.001
72463344|NCT00088452|144449082|SUPERIORITY||Odds Ratio (OR)|3.08|||<|0.001|TWO_SIDED|95.0|1.81|5.33|||Fisher Exact||Odds ratio for FFF for ethosuximide versus lamotrigine|||5.33|1.81|<0.001
72463345|NCT00088452|144449082|SUPERIORITY||Odds Ratio (OR)|2.88|||<|0.001|TWO_SIDED|95.0|1.68|5.02|||Fisher Exact||odds ratio for FFF for valproic acid versus lamotrigine|||5.02|1.68|<0.001
72621163|NCT02732145|144773181|SUPERIORITY|Question: Is there a difference in the incidence of vulvar itching versus the feeling of inflammation in the patients with vulvodynia?||||||0.0188|||||||t-test proportion|||Parameter: The difference in the incidence of vulvar itching versus the feeling of inflammation in patients with vulvodynia.||||0.0188
72621164|NCT02732145|144773181|SUPERIORITY|Question: Is there a difference in the incidence of vulvar itching versus aching in the patients with vulvodynia?||||||0.003|||||||t-test proportion|||Parameter: The difference in the incidence of vulvar itching versus aching in patients with vulvodynia.||||0.0030
72463346|NCT02329223|144449083|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.7|STANDARD_ERROR_OF_MEAN|0.815|<|0.001|TWO_SIDED|95.0|-5.31|-2.098|||Mixed Model with repeated measures(MMRM)|||||-2.098|-5.310|<0.001
72463347|NCT02329223|144449083|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.29|STANDARD_ERROR_OF_MEAN|0.828||0.006|TWO_SIDED|95.0|-3.921|-0.654|||Mixed Model with repeated measures(MMRM)|||||-0.654|-3.921|0.006
72621165|NCT02732145|144773181|SUPERIORITY|Question: Is there a difference in the incidence of vulvar aching versus burning in the patients with vulvodynia?||||||0.2155|||||||t-test proportion|||Parameter: The difference in the incidence of vulvar aching versus burning in patients with vulvodynia.||||0.2155
72463348|NCT01231464|144449098|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-1.498|||<|0.0001|TWO_SIDED|95.0|-1.897|-1.009|||ANCOVA||Besides treatment, the ANCOVA analysis also adjusted for baseline, center, gender, age, and classification of AR (Intermittent Allergic Rhinitis \[IAR\] or Persistent Allergic Rhinitis \[PER\]).|||-1.009|-1.897|<0.0001
72463349|NCT03935932|144449125|OTHER|||||||0.11|||||||Wilcoxon signed-rank|||||||0.11
72463350|NCT03935932|144449126|OTHER|||||||0.11|||||||Wilcoxon (Mann-Whitney)|||||||0.11
72463351|NCT03935932|144449127|OTHER|||||||0.35|||||||Wilcoxon signed-rank|||||||0.35
72463352|NCT00382408|144449144|SUPERIORITY_OR_OTHER||vaccine efficacy (VE)|99.31|||||TWO_SIDED|95.0|96.02|99.88||||||The vaccine efficacy (VE) was defined as: VE = 1 - R, where R = P(vaccine)/P(placebo) was the relative risk of ARD attack in subjects who received vaccines compared to placebos (Blackwelder 1993). The 95% confidence interval of the VE was obtained by inverting the Chi Square method proposed by Koopman for the ratio of two binomial proportions (Koopman 1984). The goal of the analysis of efficacy was to demonstrate a VE of at least 80% with a lower 95% confidence bound at least 60%.||99.88|96.02|
72463353|NCT00382408|144449149|SUPERIORITY_OR_OTHER||vaccine efficacy (VE)|98.46|||||TWO_SIDED|95.0|95.39|99.49||||||The vaccine efficacy (VE) was defined as: VE = 1 - R, where R = P(vaccine)/P(placebo) was the relative risk of ARD attack in subjects who received vaccines compared to placebos (Blackwelder 1993). The 95% confidence interval of the VE was obtained by inverting the Chi Square method proposed by Koopman for the ratio of two binomial proportions (Koopman 1984). The goal of the analysis of efficacy was to demonstrate a VE of at least 80% with a lower 95% confidence bound at least 60%.||99.49|95.39|
72463354|NCT00405912|144449154|SUPERIORITY_OR_OTHER|||||||0.51||95.0|||||Fisher Exact|1-sided test||Data were compared between treatment groups using Fisher's exact test for binary outcomes.||||0.51
72463355|NCT00405912|144449154|SUPERIORITY_OR_OTHER|||||||0.25||95.0|||||Fisher Exact|1-sided test||Data were compared between treatment groups using Fisher's exact test for binary outcomes.||||0.25
72463356|NCT00405912|144449155|SUPERIORITY_OR_OTHER|||||||0.52||95.0|||||Fisher Exact|1 sided test||Data were compared between treatment groups using Fisher's exact test for binary outcomes.||||0.52
72463357|NCT00405912|144449155|SUPERIORITY_OR_OTHER|||||||0.73||95.0|||||Fisher Exact|1-sided test||Data were compared between treatment groups using Fisher's exact test for binary outcomes.||||0.73
72463358|NCT03730662|144449156|NON_INFERIORITY|"Although the primary objective is to establish noninferiority, sample size selection is guided by the objective of establishing superiority. The chosen sample size and randomization ratio also provides \>90% power to establish superiority of 10 mg LY3298176 and 15 mg LY3298176 doses to insulin glargine in absence of confounding effects of rescue therapy for persistent severe hyperglycemia (efficacy estimand)."|Mean Difference (Net)|-0.99|||<|0.001|TWO_SIDED|97.5|-1.13|-0.86|||Mixed Models Analysis|||||-0.86|-1.13|<0.001
72463359|NCT03730662|144449156|NON_INFERIORITY|"Although the primary objective is to establish noninferiority, sample size selection is guided by the objective of establishing superiority. The chosen sample size and randomization ratio also provides \>90% power to establish superiority of 10 mg LY3298176 and 15 mg LY3298176 doses to insulin glargine in absence of confounding effects of rescue therapy for persistent severe hyperglycemia (efficacy estimand)."|Mean Difference (Net)|-1.14|||<|0.001|TWO_SIDED|97.5|-1.28|-1.0|||Mixed Models Analysis|||||-1.00|-1.28|<0.001
72463360|NCT03730662|144449157|NON_INFERIORITY|"Although the primary objective is to establish noninferiority, sample size selection is guided by the objective of establishing superiority. The chosen sample size and randomization ratio also provides \>90% power to establish superiority of 10 mg LY3298176 and 15 mg LY3298176 doses to insulin glargine in absence of confounding effects of rescue therapy for persistent severe hyperglycemia (efficacy estimand)."|Mean Difference (Net)|-0.8|||<|0.001|TWO_SIDED|97.5|-0.93|-0.66|||Mixed Models Analysis|||||-0.66|-0.93|<0.001
72463361|NCT03730662|144449158|SUPERIORITY||Mean Difference (Net)|-9.0|||<|0.001|TWO_SIDED|95.0|-9.8|-8.3|||Mixed Models Analysis|||||-8.3|-9.8|<0.001
72463362|NCT03730662|144449158|SUPERIORITY||Mean Difference (Net)|-11.4|||<|0.001|TWO_SIDED|95.0|-12.1|-10.6|||Mixed Models Analysis|||||-10.6|-12.1|<0.001
72463363|NCT03730662|144449158|SUPERIORITY||Mean Difference (Net)|-13.5|||<|0.001|TWO_SIDED|95.0|-14.3|-12.8|||Mixed Models Analysis|||||-12.8|-14.3|<0.001
72463364|NCT03730662|144449159|SUPERIORITY||Odds Ratio (OR)|4.78|||<|0.001|TWO_SIDED|95.0|3.47|6.58|||Regression, Logistic|||||6.58|3.47|<0.001
72463365|NCT03730662|144449159|SUPERIORITY||Odds Ratio (OR)|9.23|||<|0.001|TWO_SIDED|95.0|6.31|13.49|||Regression, Logistic|||||13.49|6.31|<0.001
72463366|NCT03730662|144449159|SUPERIORITY||Odds Ratio (OR)|11.87|||<|0.001|TWO_SIDED|95.0|7.88|17.89|||Regression, Logistic|||||17.89|7.88|<0.001
72463367|NCT03730662|144449160|SUPERIORITY||Mean Difference (Net)|1.0||||0.672|TWO_SIDED|95.0|-3.7|5.7|||Mixed Models Analysis|||||5.7|-3.7|0.672
72463368|NCT03730662|144449160|SUPERIORITY||Mean Difference (Net)|-3.6||||0.134|TWO_SIDED|95.0|-8.2|1.1|||Mixed Models Analysis|||||1.1|-8.2|0.134
72463369|NCT03730662|144449160|SUPERIORITY||Mean Difference (Net)|-8.0|||<|0.001|TWO_SIDED|95.0|-12.6|-3.4|||Mixed Models Analysis|||||-3.4|-12.6|<0.001
72463370|NCT01309243|144449164|NON_INFERIORITY_OR_EQUIVALENCE|"Null hypothesis: The FTC/RPV/TDF group was at least 12% worse than the EFV/FTC/TDF group with respect to the percentage of subjects achieving HIV-1 RNA \< 50 copies/mL (response rate, as defined by the snapshot analysis algorithm) at Week 48.~Alternative hypothesis: The FTC/RPV/TDF group was less than 12% worse than the EFV/FTC/TDF group with respect to the percentage of subjects achieving HIV-1 RNA \< 50 copies/mL at Week 48."|Difference in the response rates|4.1|||||TWO_SIDED|95.0|-1.1|9.2|||||The baseline stratum-weighted (HIV-1 RNA ≤ 100,000 and \> 100,000 copies/mL) difference in virologic success rates and its 95% CI were from baseline HIV-1 RNA adjusted Mantel-Haenszel proportions.|"The analysis was to assess the noninferiority of FTC/RPV/TDF versus EFV/FTC/TDF using a 95% confidence interval (CI) approach, with a noninferiority margin of 12% (lower bound of CI \> -12%).~700 subjects allocated 1:1 to either treatment arm was predicted to give \> 95% power when the proportion of responders in both treatment groups for the primary endpoint is 80% at Week 48."||9.2|-1.1|
72463371|NCT01309243|144449165|SUPERIORITY_OR_OTHER||Difference in the response rates|5.5|||||TWO_SIDED|95.0|-0.6|11.5|||||The baseline stratum-weighted (HIV-1 RNA ≤ 100,000 and \> 100,000 copies/mL) difference in virologic success rates and its 95% CI were from baseline HIV-1 RNA adjusted Mantel-Haenszel proportions.|||11.5|-0.6|
72563830|NCT02760264|144659029|OTHER|Treatment levels were not compared.|||||||||||||||||"Safety Population was used for this analysis. Safety Population includes all subjects who receive at least one dose of vamorolone study medication.~Treatment levels were not compared."|||
72463372|NCT01309243|144449166|SUPERIORITY_OR_OTHER||Difference in LSM|11.0||||0.34|TWO_SIDED|95.0|-11.0|32.0||The p-value, and difference in least square means (LSM) and its 95% CI are from analysis of variance (ANOVA) with treatment and baseline HIV-1 RNA levels (≤ 100,000, \> 100,000 copies/mL) as fixed effect.|ANOVA|||||32|-11|0.34
72463373|NCT01309243|144449167|SUPERIORITY_OR_OTHER||Difference in LSM|20.0||||0.17|TWO_SIDED|95.0|-9.0|49.0||The p-value, and difference in LSM and its 95% CI are from ANOVA with treatment and baseline HIV-1 RNA levels (≤ 100,000, \> 100,000 copies/mL) as fixed effect.|ANOVA|||||49|-9|0.17
72463374|NCT01309243|144449168|SUPERIORITY_OR_OTHER||||||<|0.001||||||P-value for the difference in change from baseline at Week 48 is from ANOVA with treatment as fixed effect.|ANOVA|||||||< 0.001
72463375|NCT01309243|144449169|SUPERIORITY_OR_OTHER||||||<|0.001||||||P-value for the difference in change from baseline at Week 48 is from ANOVA with treatment as fixed effect.|ANOVA|||||||< 0.001
72463376|NCT01309243|144449170|SUPERIORITY_OR_OTHER||||||<|0.001||||||P-value for the difference in change from baseline at Week 48 is from ANOVA with treatment as fixed effect.|ANOVA|||||||< 0.001
72463377|NCT01309243|144449171|SUPERIORITY_OR_OTHER||||||<|0.001||||||P-value for the difference in change from baseline at Week 48 is from ANOVA with treatment as fixed effect.|ANOVA|||||||< 0.001
72463378|NCT03930238|144449174|SUPERIORITY||Group effect from Bayesian linear mixed|1646.0|||||TWO_SIDED|||||We did perform a Bayesian analysis which provided a posterior probability of 99.76% that the daily mean steps in the intervention group exceeded the daily mean steps in the comparison group.|Bayesian linear mixed effects regression||Posterior standard deviation = 578. We have 95% credible intervals - the interval that contains 95% of the posterior probability distribution of the parameter of interest - which ranges from 511 to 2781.|||||
72463379|NCT03930238|144449175|OTHER||Percentage|53.3|||||TWO_SIDED|||||||||||||
72463380|NCT00632931|144449177|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.0||||||90.0|-0.28|6.28||||||||6.28|-0.28|
72463381|NCT00632931|144449178|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.45||||||90.0|-1.38|4.72||||||||4.72|-1.38|
72463382|NCT00632931|144449179|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.07||||||90.0|-0.17|6.31||||||||6.31|-0.17|
72463383|NCT00632931|144449180|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.84||||||90.0|-0.4|6.08||||||||6.08|-0.40|
72463384|NCT00632931|144449181|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.44||||||90.0|3.21|9.68||||||||9.68|3.21|
72463385|NCT00632931|144449182|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.33||||||90.0|1.05|7.6||||||||7.60|1.05|
72502105|NCT02770807|144534227|SUPERIORITY||Least squares mean difference|-1.4||||0.0765|TWO_SIDED|95.0|-2.957|0.152|||Mixed model for repeated measures|||Least squares means, and p-values are derived from a mixed model repeated measures analysis with baseline modified ICARS value as covariate and the fixed effects of treatment, age, sex, region and visit and the interaction term treatment-by-visit.||0.152|-2.957|0.0765
72502106|NCT02770807|144534228|SUPERIORITY||Odds Ratio (OR)|0.946||||0.8919|TWO_SIDED|95.0|0.426|2.099|||Regression, Logistic|||Logistic regression modeling (0/1), where 0 = No change or worsening and 1= improvement, with age (at 2 levels: \<10 years, ≥10 years), sex, treatment, region as fixed effects.||2.099|0.426|0.8919
72621166|NCT02732145|144773181|SUPERIORITY|Question: Is there a difference in the incidence of vulvar aching versus soreness in the patients with vulvodynia?||||||0.1508|||||||t-test proportion|||Parameter: The difference in the incidence of vulvar aching versus soreness in patients with vulvodynia.||||0.1508
72621167|NCT02732145|144773181|SUPERIORITY|Question: Is there a difference in the incidence of vulvar aching versus irritation in the patients with vulvodynia?||||||0.6364|||||||t-test proportion|||Parameter: The difference in the incidence of vulvar aching versus irritation in patients with vulvodynia.||||0.6364
72502107|NCT02770807|144534228|SUPERIORITY||Odds Ratio (OR)|1.848||||0.1255|TWO_SIDED|95.0|0.842|4.053|||Regression, Logistic|||"Logistic regression modeling (0/1), where 0 = No change or worsening and 1= improvement, with age (at 2 levels:~\<10 years, ≥10 years), sex, treatment, region as fixed effects."||4.053|0.842|0.1255
72502108|NCT02770807|144534229|SUPERIORITY||Odds Ratio (OR)|1.369||||0.4583|TWO_SIDED|95.0|0.597|3.144|||Ordinal Logistic Regression Analysis|||Odds ratio, confidence limits, and p-value derived using a proportional odds ordinal logistic regression analysis, with age (at 2 levels: \<10 years, ≥10 years), sex, treatment, region, visit, baseline CGI-S score, and treatment-by- visit interaction as fixed effects.||3.144|0.597|0.4583
72393674|NCT03975790|144294214|SUPERIORITY|||||||0.2228|||||||Chi-squared|||Anxiety||||0.2228
72463386|NCT00632931|144449183|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.66||||||90.0|-0.7|6.02||||||||6.02|-0.70|
72463387|NCT00632931|144449184|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.51||||||90.0|3.19|9.82||||||||9.82|3.19|
72463388|NCT03009019|144449185|SUPERIORITY||Odds Ratio (OR)|1.4||||0.075|TWO_SIDED|95.0|0.97|2.03|||Fisher Exact|||Last Observation Carried Forward (LOCF)||2.03|0.97|0.075
72463389|NCT03009019|144449185|SUPERIORITY||Odds Ratio (OR)|1.47||||0.055|TWO_SIDED|95.0|1.0|2.14|||Fisher Exact|||Observed cases (OC)||2.14|1.00|0.055
72463390|NCT03009019|144449186|SUPERIORITY||Odds Ratio (OR)|1.75||||0.003|TWO_SIDED|95.0|1.22|2.52|||Regression, Logistic|||||2.52|1.22|0.003
72463391|NCT03009019|144449186|SUPERIORITY||Odds Ratio (OR)|1.76||||0.003|TWO_SIDED|95.0|1.22|2.55|||Regression, Logistic|||||2.55|1.22|0.003
72463392|NCT03341312|144449210|SUPERIORITY||ratio of LS Means|0.75|||||TWO_SIDED|95.0|0.42|1.16||||||||1.16|0.42|
72463393|NCT03341312|144449210|SUPERIORITY||ratio of LS Means|0.74|||||TWO_SIDED|95.0|0.49|1.01||||||||1.01|0.49|
72463394|NCT01812707|144449213|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Threshold for significance ≤0.05|ANCOVA|||"Each treatment group was compared to placebo using ANCOVA-derived contrasts.~A hierarchical testing procedure was applied to ensure strong control of overall Type-I error rate at 0.05 level. Order was following:~1. Alirocumab 150 mg Q2W versus placebo~2. Alirocumab 75 mg Q2W versus placebo~3. Alirocumab 50 mg Q2W versus placebo~Testing continued only when high-order test was statistically significant at 5% level."||||<0.0001
72463395|NCT01812707|144449213|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Threshold for significance ≤0.05|ANCOVA|||||||<0.0001
72463396|NCT01812707|144449213|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Threshold for significance ≤0.05|ANCOVA|||||||<0.0001
72463397|NCT01697592|144449240|SUPERIORITY_OR_OTHER||Difference in the least squares means|-0.93|||<|0.001|TWO_SIDED|95.0|-1.1|-0.75|||Constrained longitudinal data analysis|Constrained longitudinal data analysis with terms for treatment, basal AHA medication, prior AHA therapy status except for basal medication, and time.||||-0.75|-1.10|<0.001
72463398|NCT01697592|144449240|SUPERIORITY_OR_OTHER||Difference in the least squares means|-0.98|||<|0.001|TWO_SIDED|95.0|-1.37|-0.6|||Constrained longitudinal data analysis|Constrained longitudinal data analysis with terms for treatment, basal AHA medication, prior AHA therapy status except for basal medication, and time.||||-0.60|-1.37|<0.001
72463399|NCT01697592|144449240|SUPERIORITY_OR_OTHER||Difference in the least squares means|-0.92|||<|0.001|TWO_SIDED|95.0|-1.29|-0.56|||Constrained longitudinal data analysis|Constrained longitudinal data analysis with terms for treatment, basal AHA medication, prior AHA therapy status except for basal medication, and time.||||-0.56|-1.29|<0.001
72463400|NCT01697592|144449240|SUPERIORITY_OR_OTHER||Difference in the least squares means|-1.16|||<|0.001|TWO_SIDED|95.0|-1.45|-0.88|||Constrained longitudinal data analysis|Constrained longitudinal data analysis with terms for treatment, basal AHA medication, prior AHA therapy status except for basal medication, and time.||||-0.88|-1.45|<0.001
72463401|NCT01697592|144449240|SUPERIORITY_OR_OTHER||Difference in the least squares means|-0.8|||<|0.001|TWO_SIDED|95.0|-1.06|-0.54|||Constrained longitudinal data analysis|Constrained longitudinal data analysis with terms for treatment, basal AHA medication, prior AHA therapy status except for basal medication, and time.||||-0.54|-1.06|<0.001
72463402|NCT00265096|144449268|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The positive test is concluded if there is a significant difference between combined golimumab and placebo groups and at least one of the pair-wise conparisons at 0.05 level.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) with stratification (stratified by baseline MTX usage).||Null Hypothesis: No difference in ACR 20 response comparing Groups I vs II and Groups I vs III. Sample size (n=396; 110 placebo, 286 combined golimumab) provided \>98% power to detect a significant difference (alpha=0.05) in ACR 20 response between treatment groups, assuming equal proportions of subjects receiving methotrexate (MTX) at baseline and the difference in ACR 20 response of 27% in subjects without MTX and 17-27% in subjects with MTX, between placebo and combined golimumab groups.||||<0.001
72463403|NCT00265096|144449268|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) with stratification (stratified by baseline MTX usage).||||||<0.001
72463404|NCT00265096|144449268|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) with stratification (stratified by baseline MTX usage).||||||<0.001
72463405|NCT00265096|144449269|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) with stratification (stratified by baseline MTX usage)||||||<0.001
72463406|NCT00265096|144449269|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) with stratification (stratified by baseline MTX usage)||||||<0.001
72463407|NCT00265096|144449269|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) with stratification (stratified by baseline MTX usage)||||||<0.001
72502109|NCT02770807|144534229|SUPERIORITY||Odds Ratio (OR)|1.371||||0.4585|TWO_SIDED|95.0|0.595|3.16|||Ordinal Logistic Regression Analysis|||Odds ratio, confidence limits, and p-value derived using a proportional odds ordinal logistic regression analysis, with age (at 2 levels: \<10 years, ≥10 years), sex, treatment, region, visit, baseline CGI-S score, and treatment-by- visit interaction as fixed effects.||3.160|0.595|0.4585
72502110|NCT02770807|144534230|SUPERIORITY||Least squares means difference|-13.33||||0.7029|TWO_SIDED|95.0|-82.261|55.601|||ANCOVA|||Least squares means difference, associated statistics, and p-values derived using ANCOVA, with age (at 2 levels: \<10 years, \>=10 years), sex, treatment, region, and baseline VABS score as fixed effects.||55.601|-82.261|0.7029
72502111|NCT02770807|144534230|SUPERIORITY||Least squares means difference|-77.31||||0.0328|TWO_SIDED|95.0|-148.201|-6.421|||ANCOVA|||Least squares means difference, associated statistics, and p-values derived using ANCOVA, with age (at 2 levels: \<10 years, \>=10 years), sex, treatment, region, and baseline VABS score as fixed effects.||-6.421|-148.201|0.0328
72463408|NCT00265096|144449270|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA on van der Waerden normal scores|With 2 factors (treatment group and subject's baseline Methotrexate (MTX) usage)||||||<0.001
72463409|NCT00265096|144449270|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA on van der Waerden normal scores|With 2 factors (treatment group and subject's baseline MTX usage)||||||<0.001
72502112|NCT02799381|144534303|SUPERIORITY|The likelihood-based mixed-effects model repeated measures (MMRM) analysis of the change from baseline to Week 12 used all observed data. The model included fixed, categorical effects for treatment, country, visit, and treatment-by-visit interaction, with continuous fixed covariates for baseline score and the baseline score-by-visit interaction.|LS Mean Difference|-15.05|||<|0.0001|TWO_SIDED|95.0|-21.47|-8.63||Two-sided p-value|Mixed-effects model repeated measures||Levodopa-Carbidopa Intestinal Gel (LCIG) - Optimized Medical Treatment (OMT) at Week 12|||-8.63|-21.47|<0.0001
72502113|NCT02799381|144534304|SUPERIORITY|The likelihood-based mixed-effects model repeated measures (MMRM) analysis of the change from baseline to Week 12 used all observed data. The model included fixed, categorical effects for treatment, country, visit, and treatment-by-visit interaction, with continuous fixed covariates for baseline score and the baseline score-by-visit interaction.|LS Mean Difference|3.27|||<|0.0001|TWO_SIDED|95.0|1.71|4.83||Two-sided p-value|Mixed-effects model repeated measures||Levodopa-Carbidopa Intestinal Gel (LCIG) - Optimized Medical Treatment (OMT) at Week 12|If the primary efficacy variable was statistically significant, each of the secondary variables were to be tested using a fixed sequence as a gatekeeping procedure and at α level of 0.050. Testing was to cease at the point that a secondary variable failed to demonstrate statistical significance.||4.83|1.71|<0.0001
72393675|NCT03975790|144294214|SUPERIORITY|||||||0.7824|||||||Chi-squared|||Anxiety||||0.7824
72463410|NCT00265096|144449270|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA on van der Waerden normal scores|With 2 factors (treatment group and subject's baseline MTX usage)||||||<0.001
72463411|NCT00265096|144449271|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA on van der Waerden normal scores|With 2 factors (treatment and subject's baseline Methotrexate (MTX) usage)||||||<0.001
72463412|NCT00265096|144449271|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA on van der Waerden normal scores|With 2 factors (with treatment and subject's baseline MTX usage)||||||<0.001
72463413|NCT00265096|144449271|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA on van der Waerden normal scores|With 2 factors (treatment and subject's baseline MTX usage)||||||<0.001
72463414|NCT00265096|144449272|SUPERIORITY_OR_OTHER|||||||0.015||||||The test was not to be performed if the test of ACR 20 at Week 24 was not significant.|ANOVA|Analysis of Variance (ANOVA) on van der Waerden scores with 2 factors: treatment group and participant's baseline methotrexate (MTX) usage||Null Hypothesis: There is no difference in change from baseline among 3 treatment groups. Sample size (n=396, 110 placebo, 286 combined golimumab) provided \>93% power to detect a significant difference (alpha=0.05) in change from baseline between treatment groups, assuming 50% of subjects received MTX at baseline, and mean change from baseline for combined golimumab of 0, and a mean increase for placebo of 0.1 in subjects who received MTX at baseline and 0.6 in subjects who did not receive MTX||||0.015
72463415|NCT00265096|144449272|SUPERIORITY_OR_OTHER|||||||0.011||||||The test was not to be performed if the test of ACR 20 at Week 24 was not significant|ANOVA|ANOVA on van der Waerden scores with 2 factors: treatment group and participant's baseline Methotrexate (MTX) usage||||||0.011
72463416|NCT00265096|144449272|SUPERIORITY_OR_OTHER|||||||0.086||||||The test was not to be performed if the test of ACR 20 at Week 24 was not significant|ANOVA|ANOVA on van der Waerden scores with 2 factors: treatment group and participant's baseline Methotrexate (MTX) usage||||||0.086
72463417|NCT00265096|144449273|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) with stratification (stratified by baseline Methotrexate (MTX) usage)||||||<0.001
72463418|NCT00265096|144449273|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) with stratification (stratified by baseline MTX usage)||||||<0.001
72463419|NCT00265096|144449273|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) with stratification (stratified by baseline MTX usage)||||||<0.001
72463420|NCT03897049|144449276|SUPERIORITY||Odds Ratio (OR)|0.961||||0.914|TWO_SIDED|95.0|0.463|1.994|||Regression, Logistic|||||1.994|0.463|0.914
72463421|NCT03897049|144449277|SUPERIORITY||Odds Ratio (OR)|0.979||||0.99|TWO_SIDED|95.0|0.473|2.074|||Regression, Logistic|||||2.074|0.473|0.990
72463422|NCT03897049|144449278|SUPERIORITY||Odds Ratio (OR)|1.434||||0.167|TWO_SIDED|95.0|0.861|2.39|||Regression, Logistic|||||2.390|0.861|0.167
72463423|NCT03897049|144449279|SUPERIORITY||Odds Ratio (OR)|1.492||||0.118|TWO_SIDED|95.0|0.903|2.466|||Regression, Logistic|||||2.466|0.903|0.118
72463424|NCT03897049|144449280|SUPERIORITY||Odds Ratio (OR)|1.335||||0.265|TWO_SIDED|95.0|0.803|2.221|||Regression, Logistic|||||2.221|0.803|0.265
72463425|NCT03897049|144449281|SUPERIORITY||Odds Ratio (OR)|0.99||||0.971|TWO_SIDED|95.0|0.593|1.654|||Regression, Logistic|||||1.654|0.593|0.971
72463426|NCT03897049|144449282|SUPERIORITY||Mean Difference (Net)|-0.27||||0.942|TWO_SIDED||||||Regression, Linear|||||||0.942
72463427|NCT03897049|144449283|SUPERIORITY||Mean Difference (Net)|0.02||||0.741|TWO_SIDED||||||Regression, Linear|||||||0.741
72621168|NCT02732145|144773181|SUPERIORITY|Question: Is there a difference in the incidence of vulvar aching versus the feeling of inflammation in the patients with vulvodynia?||||||0.5277|||||||t-test proportion|||Parameter: The difference in the incidence of vulvar aching versus the feeling of inflammation in patients with vulvodynia.||||0.5277
72463428|NCT03897049|144449284|SUPERIORITY||Mean Difference (Net)|0.07||||0.494|TWO_SIDED||||||Regression, Linear|||||||0.494
72463429|NCT03897049|144449285|SUPERIORITY||Mean Difference (Net)|0.15||||0.651|TWO_SIDED||||||Regression, Linear|||||||0.651
72463430|NCT03897049|144449286|SUPERIORITY||Mean Difference (Net)|0.3||||0.022|TWO_SIDED||||||Regression, Linear|||||||0.022
72463431|NCT03897049|144449287|SUPERIORITY||Mean Difference (Net)|2.85||||0.189|TWO_SIDED||||||Regression, Linear|||||||0.189
72463432|NCT03897049|144449288|SUPERIORITY||Mean Difference (Final Values)|3.07||||0.218|TWO_SIDED||||||Regression, Linear|||||||0.218
72463433|NCT03897049|144449289|SUPERIORITY||Odds Ratio (OR)|0.479||||0.149|TWO_SIDED|95.0|0.173|1.305|||Regression, Logistic|||||1.305|0.173|0.149
72463434|NCT03897049|144449290|SUPERIORITY||Odds Ratio (OR)|1.111||||0.839|TWO_SIDED|95.0|0.403|3.063|||Regression, Logistic|||||3.063|0.403|0.839
72463435|NCT03897049|144449291|SUPERIORITY||Odds Ratio (OR)|3.302||||0.063|TWO_SIDED|95.0|0.937|11.641|||Regression, Logistic|||||11.641|0.937|0.063
72463436|NCT03897049|144449292|SUPERIORITY||Mean Difference (Net)|-0.08||||0.65|TWO_SIDED||||||Regression, Linear|||||||0.650
72463437|NCT03897049|144449293|SUPERIORITY||Mean Difference (Net)|0.09||||0.531|TWO_SIDED||||||Regression, Linear|||||||0.531
72463438|NCT03897049|144449294|SUPERIORITY||Mean Difference (Net)|-0.03||||0.761|TWO_SIDED||||||Regression, Linear|||||||0.761
72463439|NCT03897049|144449295|SUPERIORITY||Mean Difference (Net)|0.11||||0.503|TWO_SIDED||||||Regression, Linear|||||||0.503
72463440|NCT03897049|144449296|SUPERIORITY||Mean Difference (Net)|0.01||||0.541|TWO_SIDED||||||Regression, Linear|||||||0.541
72463441|NCT03897049|144449297|SUPERIORITY||Mean Difference (Net)|-0.02||||0.537|TWO_SIDED||||||Regression, Linear|||||||0.537
72463442|NCT03897049|144449298|SUPERIORITY||Mean Difference (Net)|0.19||||0.057|TWO_SIDED||||||Regression, Linear|||||||0.057
72463443|NCT03897049|144449299|SUPERIORITY||Mean Difference (Net)|0.1||||0.402|TWO_SIDED||||||Regression, Linear|||||||0.402
72463444|NCT03897049|144449300|SUPERIORITY||Mean Difference (Net)|0.15||||0.308|TWO_SIDED||||||Regression, Linear|||||||0.308
72463445|NCT03897049|144449301|SUPERIORITY||Mean Difference (Net)|0.48||||0.001|TWO_SIDED||||||Regression, Linear|||||||0.001
72463446|NCT00666835|144449302|EQUIVALENCE|Therapeutic equivalence was defined as the two-sided 95 % confidence interval of the difference between the two treatment groups lying entirely in the interval -0.5 to 0.5 g/dL. The confidence interval of the difference was calculated based on the least square means (LSMEANS) from an analysis of co-variance model including factors treatment, center, mean baseline Hb level (\<11.5 and T11.5 g/dL) as factors and change of the mean weekly dose as a covariate.|Point estimate of difference (ANCOVA)|0.084|||||TWO_SIDED|95.0|-0.17|0.338||||||||0.338|-0.170|
72463447|NCT00666835|144449303|EQUIVALENCE|Therapeutic equivalence was defined as the two-sided 95 % confidence interval of the difference between the two treatment groups lying entirely in the interval -0.5 to 0.5 g/dL. The confidence interval of the difference was calculated based on the least square means (LSMEANS) from an analysis of co-variance model including factors treatment, center, mean baseline Hb level (\<11.5 and T11.5 g/dL) as factors and change of the mean weekly dose as a covariate.|Difference LSM of Epo Hexal & Erypo|0.189|||||TWO_SIDED|95.0|-0.039|0.418||||||||0.418|-0.039|
72463448|NCT03319719|144449308|SUPERIORITY||Mean Difference (Net)|-2.88|||<|0.0001|TWO_SIDED|95.0|-3.42|-2.33||p-value from paired two-sided t-tests of no difference between test and control groups.|t-test, 2 sided|||||-2.33|-3.42|<0.0001
72393676|NCT03975790|144294214|SUPERIORITY|||||||0.4184|||||||Chi-squared|||Liver disease||||0.4184
72393677|NCT03975790|144294214|SUPERIORITY|||||||0.4371|||||||Chi-squared|||Liver disease||||0.4371
72563831|NCT05918822|144659037|OTHER|A mixed-effects model was applied to log (ln)-transformed plasma maribavir Cmax with treatment, period, and sequence as fixed effects, and participant within sequence as random effect. Point estimates and their associated 90% confidence intervals (CIs) were constructed for differences between Treatment B (test) versus Treatment A (reference). Point estimate and their associated 90% CIs were then back transformed to provide point estimates and 90% CIs for ratios of Treatment B versus Treatment A.|Geometric Mean Ratio (GMR) (%)|82.19|||||TWO_SIDED|90.0|74.31|90.91|||||GMR (%) was calculated as 100\*(Test/Reference).|Comparison of Cmax of Maribavir: Part 1: Treatment B (Test) versus Treatment A (Reference)||90.91|74.31|
72563832|NCT05918822|144659037|OTHER|A mixed-effects model was applied to ln-transformed plasma maribavir Cmax with treatment, period, and sequence as fixed effects, and participant within sequence as a random effect. Point estimates and their associated 90 percent (%) CIs were constructed for differences between Treatment C (test) versus Treatment B (reference). Point estimates and their associated 90% CIs were then back transformed to provide point estimates and 90% CIs for ratios of Treatment C versus Treatment B.|Geometric Mean Ratio (GMR) (%)|57.72|||||TWO_SIDED|90.0|52.18|63.84|||||GMR (%) was calculated as 100\*(Test/Reference).|Comparison of Cmax of Maribavir: Part 1: Treatment C (Test) versus Treatment B (Reference)||63.84|52.18|
72563833|NCT05918822|144659037|OTHER|A mixed-effects model was applied to ln-transformed plasma maribavir Cmax with treatment as a fixed effect, and participant as a random effect. Point estimates and their associated 90% CIs were constructed for the differences between Treatment E (test) versus Treatment D (reference). The point estimates and their associated 90% CIs were then back transformed to provide point estimates and 90% CIs for the ratios of Treatment E versus Treatment D.|Geometric Mean Ratio (GMR) (%)|49.03|||||TWO_SIDED|90.0|40.07|60.0|||||GMR (%) was calculated as 100\*(Test/Reference).|Comparison of Cmax of Maribavir: Part 2: Treatment E (Test) versus Treatment D (Reference)||60.00|40.07|
72563834|NCT05918822|144659038|OTHER|A mixed-effects model was applied to ln-transformed plasma maribavir AUClast with treatment, period, and sequence as fixed effects, and participant within sequence as a random effect. Point estimates and their associated 90% CIs were constructed for differences between Treatment B (test) versus Treatment A (reference). Point estimates and their associated 90% CIs were then back transformed to provide point estimates and 90% CIs for ratios of Treatment B versus Treatment A.|Geometric Mean Ratio (GMR) (%)|97.59|||||TWO_SIDED|90.0|91.39|104.2|||||GMR (%) was calculated as 100\*(Test/Reference).|Comparison of AUClast of Maribavir: Part 1: Treatment B (Test) versus Treatment A (Reference)||104.20|91.39|
72563835|NCT05918822|144659038|OTHER|A mixed-effects model was applied to ln-transformed plasma maribavir AUClast with treatment, period, and sequence as fixed effects, and participant within sequence as a random effect. Point estimates and their associated 90% CIs were constructed for differences between Treatment C (test) versus Treatment B (reference). Point estimates and their associated 90% CIs were then back transformed to provide point estimates and 90% CIs for ratios of Treatment C versus Treatment B.|Geometric Mean Ratio (GMR) (%)|82.05|||||TWO_SIDED|90.0|76.84|87.61|||||GMR (%) was calculated as 100\*(Test/Reference).|Comparison of AUClast of Maribavir: Part 1: Treatment C (Test) versus Treatment B (Reference)||87.61|76.84|
72563836|NCT05918822|144659038|OTHER|A mixed-effects model was applied to ln-transformed plasma maribavir AUClast with treatment as a fixed effect, and participant as a random effect. Point estimates and their associated 90% CIs were constructed for the differences between Treatment E (test) versus Treatment D (reference). The point estimates and their associated 90% CIs were then back transformed to provide point estimates and 90% CIs for the ratios of Treatment E versus Treatment D.|Geometric Mean Ratio (GMR) (%)|70.0|||||TWO_SIDED|90.0|60.11|81.51|||||GMR (%) was calculated as 100\*(Test/Reference).|Comparison of AUClast of Maribavir: Part 2: Treatment E (Test) versus Treatment D (Reference)||81.51|60.11|
72621169|NCT02732145|144773181|SUPERIORITY|Question: Is there a difference in the incidence of vulvar sticking versus knife-like pain in the patients with vulvodynia who had sharp vulvar pain?||||||0.2041|||||||t-test proportion|||Parameter: The difference in the incidence of vulvar sticking versus knife-like pain in patients with vulvodynia who had sharp vulvar pain.||||0.2041
72621170|NCT02732145|144773181|SUPERIORITY|Question: Is there a difference in the incidence of vulvar sticking versus paper-cuts pain in the patients with vulvodynia who had sharp vulvar pain?||||||0.0412|||||||t-test proportion|||Parameter: The difference in the incidence of vulvar sticking versus paper-cuts pain in patients with vulvodynia who had sharp vulvar pain.||||0.0412
72621171|NCT02732145|144773181|SUPERIORITY|Question: Is there a difference in the incidence of vulvar sticking versus stabbing in the patients with vulvodynia who had sharp vulvar pain?||||||0.7978|||||||t-test proportion|||Parameter: The difference in the incidence of vulvar sticking versus stabbing in patients with vulvodynia who had sharp vulvar pain.||||0.7978
72621172|NCT02732145|144773181|SUPERIORITY|Question: Is there a difference in the incidence of vulvar stabbing versus knife-like pain in the patients with vulvodynia who had sharp vulvar pain?||||||0.3094|||||||t-test proportion|||Parameter: The difference in the incidence of vulvar stabbing versus knife-like pain in patients with vulvodynia who had sharp vulvar pain.||||0.3094
72393678|NCT03975790|144294214|SUPERIORITY|||||||0.2074|||||||Chi-squared|||Liver disease||||0.2074
72463449|NCT01212952|144449342|OTHER||Maximum Tolerated Dose (MTD) (mg/m^2)|1.3|||||TWO_SIDED||||||||Maximum Tolerated Dose Level is Dose Level 2 (1.3 mg/m\^2 Bortezomib).|||||
72393679|NCT03975790|144294214|SUPERIORITY|||||||0.785|||||||Chi-squared|||Sleep disorders||||0.7850
72393680|NCT03975790|144294214|SUPERIORITY|||||||0.1288|||||||Chi-squared|||Sleep disorders||||0.1288
72393681|NCT03975790|144294214|SUPERIORITY|||||||0.2839|||||||Chi-squared|||Sleep disorders||||0.2839
72393682|NCT03975790|144294215|SUPERIORITY|||||||0.2242|||||||Chi-squared|||||||0.2242
72393683|NCT03975790|144294215|SUPERIORITY|||||||0.0014|||||||Chi-squared|||||||0.0014
72393684|NCT03975790|144294215|SUPERIORITY|||||||0.0557|||||||Chi-squared|||||||0.0557
72393685|NCT03975790|144294216|SUPERIORITY|||||||0.5944|||||||Chi-squared|||Switch immediately||||0.5944
72393686|NCT03975790|144294216|SUPERIORITY|||||||0.9255|||||||Chi-squared|||Switch immediately||||0.9255
72393687|NCT03975790|144294216|SUPERIORITY|||||||0.7824|||||||Chi-squared|||Switch immediately||||0.7824
72463450|NCT02236598|144449353|SUPERIORITY|||||||0.5582|||||||ANCOVA|||||||0.5582
72621173|NCT02732145|144773181|SUPERIORITY|Question: Is there a difference in the incidence of vulvar stabbing versus paper-cuts pain in the patients with vulvodynia who had sharp vulvar pain?||||||0.073|||||||t-test proportion|||Parameter: The difference in the incidence of vulvar stabbing versus paper-cuts pain in patients with vulvodynia who had sharp vulvar pain.||||0.0730
72463451|NCT02236598|144449354|SUPERIORITY|Change in Fasting Glucose||||||0.0963|||||||ANCOVA|||||||0.0963
72621174|NCT02732145|144773181|EQUIVALENCE|Question: Is there a difference in the duration of vulvar complaints for more than 24 months among patients with vulvar dermatosis and vulvodynia?||||||0.4038|||||||Chi-squared|||Parameter: The difference in the duration of vulvar complaints for more than 24 months among patients with vulvar dermatosis or vulvodynia.||||0.4038
72621175|NCT02732145|144773181|EQUIVALENCE|Question: Is there a difference in the duration of vulvar complaints for more than 12 months among patients with vulvar dermatosis and vulvodynia?||||||0.7299|||||||Chi-squared|||Parameter: The difference in the duration of vulvar complaints for more than 12 months among patients with vulvar dermatosis or vulvodynia.||||0.7299
72621176|NCT02732145|144773181|EQUIVALENCE|Question: Is there a difference in the duration of vulvar complaints for more than six months among patients with vulvar dermatosis and vulvodynia?||||||0.7241|||||||Chi-squared|||Parameter: The difference in the duration of vulvar complaints for more than six months among patients with vulvar dermatosis or vulvodynia.||||0.7241
72621177|NCT02732145|144773182|EQUIVALENCE|Question: Is there a difference in the sexual activity among patients from different groups?||||||0|||||||Chi-squared|||Parameter: The difference in the sexual activity among patients from different groups.||||0.0000
72621178|NCT02732145|144773182|EQUIVALENCE|Question: Is there a difference in the frequency of dyspareunia as a cause of sexual inactivity among patients from different groups?||||||0.0006|||||||Chi-squared|||Parameter: The difference in the frequency of dyspareunia as a cause of sexual inactivity among patients from different groups.||||0.0006
72621179|NCT02732145|144773182|EQUIVALENCE|Question: Is there a difference in the frequency of sexual inactivity due to dyspareunia and lack of a sexual partner among patients from different groups?||||||0|||||||Chi-squared|||Parameter: The difference in the frequency of sexual inactivity due to dyspareunia and lack of a sexual partner among patients from different groups.||||0.0000
72621180|NCT02732145|144773183|EQUIVALENCE|Question: Is there a difference in the frequency of dyspareunia among patients from different groups?||||||0|||||||Chi-squared|||Parameter: The difference in the frequency of dyspareunia among patients from different groups.||||0.0000
72621181|NCT02732145|144773183|EQUIVALENCE|Parameter: The difference in the degree of dyspareunia (Marinoff Index) among sexually active patients with vulvodynia or vulvar dermatosis who had dyspareunia.||||||0.2999|||||||Chi-squared|||Parameter: The difference in the degree of dyspareunia (Marinoff Index) among sexually active patients with vulvodynia or vulvar dermatosis who had dyspareunia.||||0.2999
72621182|NCT02732145|144773184|EQUIVALENCE|Question: Is there a difference in the incidence of the frequency of vulvar discomfort provoked through the intercourse in patients with vulvodynia and vulvar dermatosis?||||||0|||||||Chi-squared|||Parameter: The difference in the frequency of vulvar discomfort provoked through the intercourse in patients with vulvodynia and vulvar dermatosis.||||0.0000
72621183|NCT02732145|144773184|EQUIVALENCE|Question: Is there a difference in the frequency of vulvar discomfort provoked through the penetration in patients with vulvodynia and vulvar dermatosis?||||||0.0347|||||||Chi-squared|||Parameter: The difference in the frequency of vulvar discomfort provoked through the penetration in patients with vulvodynia and vulvar dermatosis.||||0.0347
72621184|NCT02732145|144773184|EQUIVALENCE|Question: Is there a difference in the frequency of vulvar discomfort aggravated through sexual intercourse in patients with vulvodynia and vulvar dermatosis?||||||0.7068|||||||Chi-squared|||Parameter: The difference in the frequency of vulvar discomfort aggravated through sexual intercourse in patients with vulvodynia and vulvar dermatosis.||||0.7068
72621185|NCT02732145|144773184|EQUIVALENCE|Question: Is there a difference in the frequency of vulvar discomfort aggravated after sexual intercourse in patients with vulvodynia and vulvar dermatosis?||||||0.0025|||||||Chi-squared|||Parameter: The difference in the frequency of vulvar discomfort aggravated after sexual intercourse in patients with vulvodynia and vulvar dermatosis.||||0.0025
72621186|NCT02732145|144773185|SUPERIORITY|Question: Is there a difference in the frequency of use of vaginal tampon among patients with vulvodynia and vulvar dermatosis?||||||0|||||||Chi-squared|||Parameter: The difference in the frequency of use of vaginal tampon among patients with vulvodynia and vulvar dermatosis.||||0.0000
72621187|NCT02732145|144773185|SUPERIORITY|Question: Is there a difference in the frequency of worsening of vulvar discomfort due to the use of vaginal tampon in symptomatic patients, who use vaginal tampons?||||||0.6552|||||||Chi-squared|||Parameter: The difference in the frequency of worsening of vulvar discomfort due to the use of vaginal tampon in symptomatic patients, who use vaginal tampons.||||0.6552
72463452|NCT02236598|144449354|SUPERIORITY|Change in 1-hour Glucose||||||0.6671|||||||ANCOVA|||||||0.6671
72621188|NCT02732145|144773185|SUPERIORITY|Question: Is there a difference in the frequency of cycling among patients with vulvodynia and vulvar dermatosis?||||||0.0002|||||||Chi-squared|||Parameter: The difference in the frequency of cycling among patients with vulvodynia and vulvar dermatosis.||||0.0002
72621189|NCT02732145|144773185|SUPERIORITY|Question: Is there a difference in the frequency of worsening of vulvar discomfort due to the cycling in symptomatic patients, who ride a bicycle?||||||0.2877|||||||Chi-squared|||Parameter: The difference in the frequency of worsening of vulvar discomfort due to the cycling in symptomatic patients, who ride a bicycle.||||0.2877
72621190|NCT02732145|144773185|SUPERIORITY|Question: Is there a difference in the frequency of wearing tight clothes among patients with vulvar dermatosis and vulvodynia?||||||0.0001|||||||Chi-squared|||Parameter: The difference in the frequency of wearing tight clothes among patients with vulvar dermatosis and vulvodynia.||||0.0001
72463453|NCT02236598|144449354|SUPERIORITY|Change in 2-hour Glucose||||||0.7913|||||||ANCOVA|||||||0.7913
72463454|NCT02236598|144449355|SUPERIORITY|||||||0.5294|||||||ANCOVA|||||||0.5294
72463455|NCT02236598|144449356|SUPERIORITY|||||||0.1604|||||||ANCOVA|||||||0.1604
72463456|NCT01061775|144449368|SUPERIORITY_OR_OTHER_LEGACY|||||||0.05|TWO_SIDED|95.0|||||t-test, 2 sided|||||||.05
72463457|NCT01061775|144449369|SUPERIORITY_OR_OTHER_LEGACY|||||||0.05|TWO_SIDED||||||t-test, 2 sided|||||||0.05
72463458|NCT01061775|144449370|SUPERIORITY_OR_OTHER_LEGACY|||||||0.05|TWO_SIDED||||||t-test, 2 sided|||||||0.05
72463459|NCT01061775|144449371|SUPERIORITY_OR_OTHER_LEGACY|||||||0.05|TWO_SIDED||||||t-test, 2 sided|||||||0.05
72463460|NCT04089332|144449404|OTHER||Slope|-0.4465||||0.162|TWO_SIDED||||||Regression, Linear|||WASI II (Verbal IQ) vs HOMA-IR|Adjusted R-squared = 0.117|||0.162
72463461|NCT04089332|144449404|OTHER||Slope|0.6704||||0.082|TWO_SIDED||||||Regression, Linear|||WASI II (Performance IQ) vs HOMA-IR|Adjusted R-squared = 0.221|||0.082
72463462|NCT04089332|144449404|OTHER||Slope|-0.8486||||0.286|TWO_SIDED||||||Regression, Linear|||NIH Toolbox (Flanker Inhibitory Control and Attention) vs HOMA-IR|Adjusted R-squared = 0.0503|||0.286
72463463|NCT04089332|144449404|OTHER||Slope|-0.0266||||0.635|TWO_SIDED||||||Regression, Linear|||NIH Toolbox (Pattern Comparison) vs HOMA-IR|Adjusted R-squared = 0|||0.635
72463464|NCT04089332|144449404|OTHER||Slope|-0.1588||||0.061|TWO_SIDED||||||Regression, Linear|||NIH Toolbox (Picture Sequence) vs HOMA-IR|Adjusted R-squared = 0.381|||0.061
72463465|NCT04089332|144449404|OTHER||Slope|0.099||||0.479|TWO_SIDED||||||Regression, Linear|||WRAML (Picture Memory) vs. HOMA-IR|Adjusted R-squared = 0|||0.479
72463466|NCT04089332|144449404|OTHER||Slope|0.0676||||0.965|TWO_SIDED||||||Regression, Linear|||D-KEFS (Color-Word Interference) vs. HOMA-IR|Adjusted R-squared = 0|||0.965
72463467|NCT04089332|144449404|OTHER||Slope|-0.0091||||0.039|TWO_SIDED||||||Regression, Linear|||D-KEFS (Trail Making Test) vs. HOMA-IR|Adjusted R-squared = 0.324|||0.039
72463468|NCT04089332|144449404|OTHER||Slope|-4.2085||||0.018|TWO_SIDED||||||Regression, Linear|||PedsQL (Child 8-12 / Teen 13-18) vs. HOMA-IR|Adjusted R-squared = 0.0423|||0.018
72463469|NCT04089332|144449405|OTHER||Slope|-1.1138||||0.558|TWO_SIDED||||||Regression, Linear|||Change in Gray Matter Perfusion vs. HOMA-IR|Adjusted R-square = 0|||0.558
72463470|NCT04089332|144449405|OTHER||Slope|-5.8089||||0.057|TWO_SIDED||||||Regression, Linear|||Baseline Gray Matter vs. HOMA-IR|Adjusted R-squared = 0.18|||0.057
72463471|NCT04089332|144449406|OTHER||Slope|-0.4465||||0.377|TWO_SIDED||||||Regression, Linear|||WASI II (Verbal IQ) vs. Cerebral Blood Flow|Adjusted R-squared = 0|||0.377
72621191|NCT02732145|144773185|SUPERIORITY|Question: Is there a difference in the frequency of worsening of vulvar discomfort due to wearing of tight clothes in symptomatic patients, who wear tight clothes?||||||0.4754|||||||Chi-squared|||Parameter: The difference in the frequency of worsening of vulvar discomfort due to wearing of tight clothes in symptomatic patients, who wear tight clothes.||||0.4754
72393688|NCT03975790|144294216|SUPERIORITY|||||||0.3975|||||||Chi-squared|||Discontinue then switch||||0.3975
72463472|NCT04089332|144449406|OTHER||Slope|0.6704||||0.402|TWO_SIDED||||||Regression, Linear|||WASI II (Performance IQ) vs. Cerebral Blood Flow|Adjusted R-squared = 0|||0.402
72463473|NCT04089332|144449406|OTHER||Slope|-0.8486||||0.203|TWO_SIDED||||||Regression, Linear|||NIH Toolbox (Flanker Inhibitory Control and Attention) vs. Cerebral Blood Flow|Adjusted R-squared = 0.207|||0.203
72463474|NCT04089332|144449406|OTHER||Slope|-0.0266||||0.967|TWO_SIDED||||||Regression, Linear|||NIH Toolbox (Pattern Comparison) vs. Cerebral Blood Flow|Adjusted R-squared = 0|||0.967
72463475|NCT04089332|144449406|OTHER||Slope|-0.1588||||0.616|TWO_SIDED||||||Regression, Linear|||NIH Toolbox (Picture Sequence) vs. Cerebral Blood Flow|Adjusted R-squared = 0|||0.616
72463476|NCT04089332|144449406|OTHER||Slope|0.099||||0.287|TWO_SIDED||||||Regression, Linear|||WRAML (Picture Memory) vs. Cerebral Blood Flow|Adjusted R-squared = 0.0497|||0.287
72463477|NCT04089332|144449406|OTHER||Slope|0.0676||||0.225|TWO_SIDED||||||Regression, Linear|||D-KEFS (Color-Word Interference) vs. Cerebral Blood Flow|Adjusted R-squared = 0.106|||0.225
72393689|NCT03975790|144294216|SUPERIORITY|||||||0.0552|||||||Chi-squared|||Discontinue then switch||||0.0552
72463478|NCT04089332|144449406|OTHER||Slope|-0.0091||||0.872|TWO_SIDED||||||Regression, Linear|||D-KEFS (Trail Making Test) vs. Cerebral Blood Flow|Adjusted R-squared = 0|||0.872
72463479|NCT04089332|144449406|OTHER||Slope|-4.2085||||0.66|TWO_SIDED||||||Regression, Linear|||PedsQL (Child 8-12 / Teen 13-18) vs. Cerebral Blood Flow|Adjusted R-squared = 0|||0.66
72463480|NCT00581009|144449427|EQUIVALENCE|repeated measure ANOVA|t-value|3.34|||<|0.05|TWO_SIDED||||||ANOVA|||||||<0.05
72463481|NCT02256488|144449428|NON_INFERIORITY_OR_EQUIVALENCE|"The lot-to-lot consistency was claimed if the 2-sided 95% CIs of all the three pairwise comparisons was within the equivalence ranges, that is:~(μlot A - μlot B) \> -0.176 and (μlot A - μlot B) \< 0.176 and (μlot A - μlot C) \> -0.176 and (μlot A - μlot C) \< 0.176 and (μlot B - μlot C) \> -0.176 and (μlot B - μlot C) \< 0.176"|Ratio of GMTs|0.9|||||TWO_SIDED|95.0|0.667|1.5|||ANCOVA|||To demonstrate immunologic equivalence of three consecutive TIVc production lots as evaluated by HI antibody responses after vaccination for all 3 influenza strains at day 22.||1.5|0.667|
72463482|NCT02256488|144449428|NON_INFERIORITY_OR_EQUIVALENCE|"The lot-to-lot consistency was claimed if the 2-sided 95% CIs of all the three pairwise comparisons was within the equivalence ranges, that is:~(μlot A - μlot B) \> -0.176 and (μlot A - μlot B) \< 0.176 and (μlot A - μlot C) \> -0.176 and (μlot A - μlot C) \< 0.176 and (μlot B - μlot C) \> -0.176 and (μlot B - μlot C) \< 0.176"|Ratio of GMTs|1.02|||||TWO_SIDED|95.0|0.667|1.5|||ANCOVA|||To demonstrate immunologic equivalence of three consecutive TIVc production lots as evaluated by HI antibody responses after vaccination for for all 3 influenza strains at day 22||1.5|0.667|
72463483|NCT02256488|144449428|NON_INFERIORITY_OR_EQUIVALENCE|"The lot-to-lot consistency was claimed if the 2-sided 95% CIs of all the three pairwise comparisons was within the equivalence ranges, that is:~(μlot A - μlot B) \> -0.176 and (μlot A - μlot B) \< 0.176 and (μlot A - μlot C) \> -0.176 and (μlot A - μlot C) \< 0.176 and (μlot B - μlot C) \> -0.176 and (μlot B - μlot C) \< 0.176"|Ratio of GMTs|1.12|||||TWO_SIDED|95.0|0.667|1.5|||ANCOVA|||To demonstrate immunologic equivalence of three consecutive TIVc production lots as evaluated by HI antibody responses after vaccination for all 3 influenza strains at day 22||1.5|0.667|
72393690|NCT03975790|144294216|SUPERIORITY|||||||0.3914|||||||Chi-squared|||Discontinue then switch||||0.3914
72393691|NCT03975790|144294216|SUPERIORITY|||||||0.2036|||||||Chi-squared|||Discontinue then restart||||0.2036
72463484|NCT02963922|144449675|SUPERIORITY|The treatment policy estimand evaluated the treatment effect (liraglutide 3.0 mg vs placebo) at week 56 for all randomised participants regardless of premature discontinuation of trial product.|Treatment difference|-4.32|STANDARD_ERROR_OF_MEAN|0.59|<|0.0001|TWO_SIDED|95.0|-5.48|-3.16|||ANCOVA||Liraglutide 3.0 mg - placebo|Analysis of in-trial data with missing observations imputed from the placebo arm based on a jump to reference multiple (x100) imputation approach. Week 56 responses were analysed using an analysis of covariance model with treatment, body mass index (BMI) groups and sex as factors and baseline body weight as covariate.||-3.16|-5.48|< .0001
72563837|NCT05918822|144659039|OTHER|A mixed-effects model was applied to ln-transformed plasma maribavir AUC0-infinity with treatment, period, and sequence as fixed effects, and participant within sequence as a random effect. Point estimates and their associated 90% CIs were constructed for differences between Treatment B (test) versus Treatment A (reference). Point estimates and their associated 90% CIs were then back transformed to provide point estimates and 90% CIs for ratios of Treatment B versus Treatment A.|Geometric Mean Ratio (GMR) (%)|99.94|||||TWO_SIDED|90.0|94.12|106.11|||||GMR (%) was calculated as 100\*(Test/Reference).|Comparison of AUC0-infinity of Maribavir: Part 1: Treatment B (Test) versus Treatment A (Reference)||106.11|94.12|
72621192|NCT02732145|144773185|SUPERIORITY|Question: Is there a difference in the frequency of worsening of vulvar discomfort depending on the menstrual cycle in symptomatic patients of reproductive age?||||||0.1082|||||||Chi-squared|||Parameter: The difference in the frequency of worsening of vulvar discomfort depending on the menstrual cycle in symptomatic patients of reproductive age.||||0.1082
72621193|NCT02732145|144773185|SUPERIORITY|Question: Is there a difference in the frequency of worsening of vulvar discomfort before starting menstrual bleeding in symptomatic patients of reproductive age?||||||0.0179|||||||Chi-squared|||Parameter: The difference in the frequency of worsening of vulvar discomfort before starting menstrual bleeding in symptomatic patients of reproductive age.||||0.0179
72463485|NCT02963922|144449675|SUPERIORITY|The hypothetical estimand evaluated the treatment effect (liraglutide 3.0 mg vs placebo) for all randomised participants assuming that all participants remained on trial product (on-treatment principle).|Treatment difference|-5.1|STANDARD_ERROR_OF_MEAN|0.61|<|0.0001|TWO_SIDED|95.0|-6.3|-3.91|||MMRM||Liraglutide 3.0 mg - placebo|Analysis of on-drug before first drug discontinuation date using a mixed model for repeated measurements with treatment, BMI groups and sex as factors and baseline body weight as covariate, all nested within visit.||-3.91|-6.30|< .0001
72463486|NCT02963922|144449676|SUPERIORITY||Odds Ratio (OR)|3.41|||<|0.0001|TWO_SIDED|95.0|2.19|5.31|||Regression, Logistic||Liraglutide 3.0 mg/Placebo|Analysis of in-trial data with missing observations imputed from the placebo arm based on a jump to reference multiple (x100) imputation approach. Week 56 responses were analysed using a logistic regression model with treatment, BMI groups and sex as factors and baseline body weight as covariate.||5.31|2.19|<.0001
72463487|NCT02963922|144449676|SUPERIORITY||Odds Ratio (OR)|4.73|||<|0.0001|TWO_SIDED|95.0|3.04|7.36|||Mixed model for repeated measurements||Liraglutide 3.0 mg/Placebo|Analysis of on-drug before first drug discontinuation date using a mixed model for repeated measurements with treatment, BMI groups and sex as factors and baseline body weight as covariate, all nested within visit. The MMRM was used to classify responders and analysed with a logistic regression with treatment as the only factor.||7.36|3.04|<.0001
72463488|NCT03740919|144449740|NON_INFERIORITY|Noninferiority margin \[NIM\]=0.4% for HbA1c|Least Squares (LS) Mean Difference|-0.02||||0.783|TWO_SIDED|95.0|-0.17|0.13|||Mixed Models Analysis|||||0.13|-0.17|0.783
72463489|NCT03740919|144449741|NON_INFERIORITY|NIM of 0.4%|LS Mean Difference|-0.02||||0.867|TWO_SIDED|95.0|-0.2|0.17|||Mixed Models Analysis|||||0.17|-0.20|0.867
72463490|NCT03740919|144449742|SUPERIORITY||Odds Ratio (OR)|1.61||||0.008|TWO_SIDED|95.0|1.13|2.3|||Regression, Logistic|||\< 54 mg/dL 1 hour post-dose||2.30|1.13|0.008
72463491|NCT03740919|144449742|SUPERIORITY||Odds Ratio (OR)|1.17||||0.487|TWO_SIDED|95.0|0.75|1.83|||Regression, Logistic|||\< 54 mg/dL 1 hour post-dose||1.83|0.75|0.487
72463492|NCT03740919|144449742|SUPERIORITY||Odds Ratio (OR)|0.73||||0.153|TWO_SIDED|95.0|0.47|1.13|||Regression, Logistic|||\< 54 mg/dL 1 hour post-dose||1.13|0.47|0.153
72463493|NCT03740919|144449742|SUPERIORITY||Odds Ratio (OR)|1.49||||0.02|TWO_SIDED|95.0|1.06|2.08|||Regression, Logistic|||\< 54 mg/dL 2 hour post-dose||2.08|1.06|0.020
72463494|NCT03740919|144449742|SUPERIORITY||Odds Ratio (OR)|1.17||||0.455|TWO_SIDED|95.0|0.78|1.76|||Regression, Logistic|||\< 54 mg/dL 2 hour post-dose||1.76|0.78|0.455
72463495|NCT03740919|144449742|SUPERIORITY||Odds Ratio (OR)|0.79||||0.259|TWO_SIDED|95.0|0.52|1.19|||Regression, Logistic|||\< 54 mg/dL 2 hour post-dose||1.19|0.52|0.259
72463496|NCT03740919|144449742|SUPERIORITY||Odds Ratio (OR)|1.79|||<|0.001|TWO_SIDED|95.0|1.29|2.51|||Regression, Logistic|||≤ 70 mg/dL 1 hour post-dose||2.51|1.29|<0.001
72463497|NCT03740919|144449742|SUPERIORITY||Odds Ratio (OR)|0.95||||0.822|TWO_SIDED|95.0|0.64|1.43|||Regression, Logistic|||≤ 70 mg/dL 1 hour post-dose||1.43|0.64|0.822
72463498|NCT03740919|144449742|SUPERIORITY||Odds Ratio (OR)|0.53||||0.003|TWO_SIDED|95.0|0.35|0.8|||Regression, Logistic|||≤ 70 mg/dL 1 hour post-dose||0.80|0.35|0.003
72463499|NCT03740919|144449742|SUPERIORITY||Odds Ratio (OR)|1.42||||0.092|TWO_SIDED|95.0|0.94|2.14|||Regression, Logistic|||≤ 70 mg/dL 2 hour post-dose||2.14|0.94|0.092
72463500|NCT03740919|144449742|SUPERIORITY||Odds Ratio (OR)|0.71||||0.133|TWO_SIDED|95.0|0.45|1.11|||Regression, Logistic|||≤ 70 mg/dL 2 hour post-dose||1.11|0.45|0.133
72393692|NCT03975790|144294216|SUPERIORITY|||||||0.1336|||||||Chi-squared|||Discontinue then restart||||0.1336
72463501|NCT03740919|144449742|SUPERIORITY||Odds Ratio (OR)|0.5||||0.004|TWO_SIDED|95.0|0.31|0.8|||Regression, Logistic|||≤ 70 mg/dL 2 hour post-dose||0.80|0.31|0.004
72463502|NCT03740919|144449743|SUPERIORITY|||||||0.22|||||||Negative binomial regression|Treatment and age group as covariates, log (exposure/365.25 days) as the offset in the model.||\< 54 mg/dL 1 hour post-dose||||0.220
72463503|NCT03740919|144449743|SUPERIORITY|||||||0.599|||||||Negative binomial regression|Treatment and age group as covariates, log (exposure/365.25 days) as the offset in the model.||\< 54 mg/dL 1 hour post-dose||||0.599
72463504|NCT03740919|144449743|SUPERIORITY|||||||0.112|||||||Negative binomial regression|Treatment and age group as covariates, log (exposure/365.25 days) as the offset in the model.||\< 54 mg/dL 1 hour post-dose||||0.112
72463505|NCT03740919|144449743|SUPERIORITY|||||||0.034|||||||Negative binomial regression|Treatment and age group as covariates, log (exposure/365.25 days) as the offset in the model.||\< 54 mg/dL 2 hour post-dose||||0.034
72463506|NCT03740919|144449743|SUPERIORITY|||||||0.055|||||||Negative binomial regression|Treatment and age group as covariates, log (exposure/365.25 days) as the offset in the model.||\< 54 mg/dL 2 hour post-dose||||0.055
72463507|NCT03740919|144449743|SUPERIORITY|||||||0.814|||||||Negative binomial regression|Treatment and age group as covariates, log (exposure/365.25 days) as the offset in the model.||\< 54 mg/dL 2 hour post-dose||||0.814
72463508|NCT03740919|144449743|SUPERIORITY|||||||0.194|||||||Negative binomial regression|||≤70 mg/dL 1 hour post-dose||||0.194
72463509|NCT03740919|144449743|SUPERIORITY|||||||0.428|||||||Negative binomial regression|Treatment and age group as covariates, log (exposure/365.25 days) as the offset in the model.||≤70 mg/dL 1 hour post-dose||||0.428
72393693|NCT03975790|144294216|SUPERIORITY|||||||0.7095|||||||Chi-squared|||Discontinue then restart||||0.7095
72393694|NCT03975790|144294216|SUPERIORITY|||||||0.2241|||||||Chi-squared|||Discontinue without switch or restart||||0.2241
72393695|NCT03975790|144294216|SUPERIORITY|||||||0.0024|||||||Chi-squared|||Discontinue without switch or restart||||0.0024
72463510|NCT03740919|144449743|SUPERIORITY|||||||0.057|||||||Negative binomial regression|Treatment and age group as covariates, log (exposure/365.25 days) as the offset in the model.||≤70 mg/dL 1 hour post-dose||||0.057
72463511|NCT03740919|144449743|SUPERIORITY|||||||0.056|||||||Negative binomial regression|Treatment and age group as covariates, log (exposure/365.25 days) as the offset in the model||≤70 mg/dL 2 hour post-dose||||0.056
72463512|NCT03740919|144449743|SUPERIORITY|||||||0.435|||||||Negative binomial regression|Treatment and age group as covariates, log (exposure/365.25 days) as the offset in the model.||≤70 mg/dL 2 hour post-dose||||0.435
72463513|NCT03740919|144449743|SUPERIORITY|||||||0.404|||||||Negative binomial regression|Treatment and age group as covariates, log (exposure/365.25 days) as the offset in the model.||≤70 mg/dL 2 hour post-dose||||0.404
72463514|NCT03740919|144449744|SUPERIORITY||Odds Ratio (OR)|1.04||||0.864|TWO_SIDED|95.0|0.68|1.57|||Regression, Logistic|||\<54 mg/dL||1.57|0.68|0.864
72463515|NCT03740919|144449744|SUPERIORITY||Odds Ratio (OR)|0.69||||0.132|TWO_SIDED|95.0|0.43|1.12|||Regression, Logistic|||\<54 mg/dL||1.12|0.43|0.132
72463516|NCT03740919|144449744|SUPERIORITY||Odds Ratio (OR)|0.67||||0.104|TWO_SIDED|95.0|0.41|1.09|||Regression, Logistic|||||1.09|0.41|0.104
72463517|NCT03740919|144449744|SUPERIORITY||Odds Ratio (OR)|0.8||||0.489|TWO_SIDED|95.0|0.42|1.52|||Regression, Logistic|||≤70 mg/dL||1.52|0.42|0.489
72621194|NCT02732145|144773185|SUPERIORITY|Question: Is there a difference in the frequency of worsening of vulvar discomfort during menstrual bleeding in symptomatic patients of reproductive age?||||||0.5722|||||||Chi-squared|||Parameter: The difference in the frequency of worsening of vulvar discomfort during menstrual bleeding in symptomatic patients of reproductive age.||||0.5722
72621195|NCT02732145|144773185|SUPERIORITY|Question: Is there a difference in the frequency of worsening of vulvar discomfort after menstrual bleeding in symptomatic patients of reproductive age?||||||0.6148|||||||Chi-squared|||Parameter: The difference in the frequency of worsening of vulvar discomfort after menstrual bleeding in symptomatic patients of reproductive age.||||0.6148
72393696|NCT03975790|144294216|SUPERIORITY|||||||0.1204|||||||Chi-squared|||Discontinue without switch or restart||||0.1204
72393697|NCT03975790|144294217|SUPERIORITY|||||||0.8424|||||||Chi-squared|||||||0.8424
72393698|NCT03975790|144294217|SUPERIORITY|||||||0.3278|||||||Chi-squared|||||||0.3278
72393699|NCT03975790|144294217|SUPERIORITY|||||||0.3336|||||||Chi-squared|||||||0.3336
72393700|NCT03975790|144294218|SUPERIORITY|||||||0.2036|||||||Chi-squared|||||||0.2036
72393701|NCT03975790|144294218|SUPERIORITY|||||||0.1336|||||||Chi-squared|||||||0.1336
72393702|NCT03975790|144294218|SUPERIORITY|||||||0.7095|||||||Chi-squared|||||||0.7095
72393703|NCT03975790|144294220|SUPERIORITY||||||<|0.0001|||||||t-test|||||||<0.0001
72393704|NCT03975790|144294220|SUPERIORITY||||||<|0.0001|||||||t-test|||||||<.0001
72393705|NCT03975790|144294220|SUPERIORITY||||||<|0.0001|||||||t-test|||||||<.0001
72393706|NCT03975790|144294221|SUPERIORITY|||||||0.0309|||||||Chi-squared|||Leflunomide||||0.0309
72393707|NCT03975790|144294221|SUPERIORITY|||||||0.9978|||||||Chi-squared|||Leflunomide||||0.9978
72393708|NCT03975790|144294221|SUPERIORITY|||||||0.2629|||||||Chi-squared|||Leflunomide||||0.2629
72393709|NCT03975790|144294221|SUPERIORITY|||||||0.0225|||||||Chi-squared|||Sulfasalazine||||0.0225
72393710|NCT03975790|144294221|SUPERIORITY|||||||0.4456|||||||Chi-squared|||Sulfasalazine||||0.4456
72393711|NCT03975790|144294221|SUPERIORITY|||||||0.5065|||||||Chi-squared|||Sulfasalazine||||0.5065
72393712|NCT03975790|144294221|SUPERIORITY|||||||0.6617|||||||Chi-squared|||Hydroxychloroquine||||0.6617
72393713|NCT03975790|144294221|SUPERIORITY|||||||0.7309|||||||Chi-squared|||Hydroxychloroquine||||0.7309
72393714|NCT03975790|144294221|SUPERIORITY|||||||0.9861|||||||Chi-squared|||Hydroxychloroquine||||0.9861
72463518|NCT03740919|144449744|SUPERIORITY||Odds Ratio (OR)|0.45||||0.025|TWO_SIDED|95.0|0.23|0.9|||Regression, Logistic|||≤70 mg/dL||0.90|0.23|0.025
72463519|NCT03740919|144449744|SUPERIORITY||Odds Ratio (OR)|0.57||||0.099|TWO_SIDED|95.0|0.29|1.11|||Regression, Logistic|||≤70 mg/dL||1.11|0.29|0.099
72463520|NCT03740919|144449745|SUPERIORITY|||||||0.732|||||||Negative binomial regression|||\< 54 mg/dL||||0.732
72463521|NCT03740919|144449745|SUPERIORITY|||||||0.638|||||||Negative binomial regression|||\< 54 mg/dL||||0.638
72463522|NCT03740919|144449745|SUPERIORITY|||||||0.462|||||||Negative binomial regression|||\<54 mg/dL||||0.462
72463523|NCT03740919|144449745|SUPERIORITY|||||||0.632|||||||Negative binomial regression|||≤ 70 mg/dL||||0.632
72463524|NCT03740919|144449745|SUPERIORITY|||||||0.8|||||||Negative binomial regression|||≤ 70 mg/dL||||0.800
72463525|NCT03740919|144449745|SUPERIORITY|||||||0.889|||||||Negative binomial regression|||≤ 70 mg/dL||||0.889
72463526|NCT03740919|144449747|SUPERIORITY||LS Mean Difference|0.6||||0.13|TWO_SIDED|95.0|-0.2|1.4|||Mixed Models Analysis|||Total Daily Basal Insulin||1.4|-0.2|0.130
72463527|NCT03740919|144449747|SUPERIORITY||LS Mean Difference|0.4||||0.404|TWO_SIDED|95.0|-0.5|1.4|||Mixed Models Analysis|||Total Daily Basal Insulin||1.4|-0.5|0.404
72463528|NCT03740919|144449747|SUPERIORITY||LS Mean Difference|-0.2||||0.693|TWO_SIDED|95.0|-1.2|0.8|||Mixed Models Analysis|||Total Daily Basal Insulin||0.8|-1.2|0.693
72463529|NCT03740919|144449747|SUPERIORITY||LS Mean Difference|0.5||||0.625|TWO_SIDED|95.0|-1.4|2.3|||Mixed Models Analysis|||Total Daily Insulin Dose||2.3|-1.4|0.625
72463530|NCT03740919|144449747|SUPERIORITY||LS Mean Difference|-0.4||||0.758|TWO_SIDED|95.0|-2.6|1.9|||Mixed Models Analysis|||Total Daily Insulin Dose||1.9|-2.6|0.758
72463531|NCT03740919|144449747|SUPERIORITY||Mean Difference (Final Values)|-0.8||||0.485|TWO_SIDED|95.0|-3.1|1.5|||Mixed Models Analysis|||Total Daily Insulin Dose||1.5|-3.1|0.485
72463532|NCT03740919|144449748|SUPERIORITY||Odds Ratio (OR)|1.23||||0.396|TWO_SIDED|95.0|0.76|2.0|||Regression, Logistic|||HbA1c \< 7%||2.00|0.76|0.396
72463533|NCT03740919|144449748|SUPERIORITY||Odds Ratio (OR)|0.93||||0.814|TWO_SIDED|95.0|0.49|1.75|||Regression, Logistic|||HbA1c \< 7%||1.75|0.49|0.814
72563838|NCT05918822|144659039|OTHER|A mixed-effects model was applied to ln-transformed plasma maribavir AUC0-infinity with treatment, period, and sequence as fixed effects, and participant within sequence as a random effect. Point estimates and their associated 90% CIs were constructed for differences between Treatment C (test) versus Treatment B (reference). Point estimates and their associated 90% CIs were then back transformed to provide point estimates and 90% CIs for ratios of Treatment C versus Treatment B.|Geometric Mean Ratio (GMR) (%)|81.68|||||TWO_SIDED|90.0|76.93|86.73||||||Comparison of AUC0-infinity of Maribavir: Part 1: Treatment C (Test) versus Treatment B (Reference)||86.73|76.93|
72463534|NCT03740919|144449748|SUPERIORITY||Odds Ratio (OR)|0.75||||0.384|TWO_SIDED|95.0|0.39|1.43|||Regression, Logistic|||HbA1c \< 7%||1.43|0.39|0.384
72463535|NCT03740919|144449748|SUPERIORITY||Odds Ratio (OR)|0.84||||0.4|TWO_SIDED|95.0|0.55|1.27|||Regression, Logistic|||HbA1c \< 7.5%||1.27|0.55|0.400
72463536|NCT03740919|144449748|SUPERIORITY||Odds Ratio (OR)|0.62||||0.094|TWO_SIDED|95.0|0.36|1.08|||Regression, Logistic|||HbA1c \< 7.5%||1.08|0.36|0.094
72463537|NCT03740919|144449748|SUPERIORITY||Odds Ratio (OR)|0.75||||0.306|TWO_SIDED|95.0|0.43|1.31|||Regression, Logistic|||HbA1c \< 7.5%||1.31|0.43|0.306
72463538|NCT03873038|144449762|OTHER|Geometric mean ratio (GMR) was derived using the geometric mean (GM) for participants with ESRD and the GM from historical data obtained from a study of MK-2060 in healthy participants (PN001).|GMR|0.8|||||TWO_SIDED|90.0|0.54|1.18|||||GMR=GM ESRD/GM Healthy|||1.18|0.54|
72463539|NCT03873038|144449762|OTHER|GMR was derived using GM for participants with ESRD and the GM from historical data obtained from a study of MK-2060 in healthy participants (PN001).|GMR|0.53|||||TWO_SIDED|90.0|0.37|0.76|||||GMR=GM ESRD/GM Healthy|||0.76|0.37|
72463540|NCT03873038|144449762|OTHER||GMR|0.82|||||TWO_SIDED|90.0|0.55|1.21|||||GMR=GM ESRD/GM Healthy|GMR was derived using GM for participants with ESRD and the GM from historical data obtained from a study of MK-2060 in healthy participants (PN001).||1.21|0.55|
72463541|NCT03873038|144449763|OTHER||GMR|1.41|||||TWO_SIDED|90.0|1.07|1.85|||||GMR=GM ESRD/GM Healthy|GMR was derived using GM for participants with ESRD and the GM from historical data obtained from a study of MK-2060 in healthy participants (PN001).||1.85|1.07|
72463542|NCT03873038|144449763|OTHER||GMR|0.86|||||TWO_SIDED|90.0|0.67|1.11|||||GMR=GM ESRD/GM Healthy|GMR was derived using GM for participants with ESRD and the GM from historical data obtained from a study of MK-2060 in healthy participants (PN001)||1.11|0.67|
72463543|NCT03873038|144449763|OTHER||GMR|0.82|||||TWO_SIDED|90.0|0.62|1.08|||||GMR=GM ESRD/GM Healthy|GMR was derived using GM for participants with ESRD and the GM from historical data obtained from a study of MK-2060 in healthy participants (PN001).||1.08|0.62|
72463544|NCT03873038|144449764|OTHER||GMR|1.11|||||TWO_SIDED|90.0|0.84|1.46|||||GMR=GM ESRD/GM Healthy|GMR was derived using GM for participants with ESRD and the GM from historical data obtained from a study of MK-2060 in healthy participants (PN001).||1.46|0.84|
72502114|NCT02799381|144534305|SUPERIORITY|The likelihood-based mixed-effects model repeated measures (MMRM) analysis of the change from baseline to Week 12 used all observed data. The model included fixed, categorical effects for treatment, country, visit, and treatment-by-visit interaction, with continuous fixed covariates for baseline score and the baseline score-by-visit interaction.|LS Mean Difference|-16.66|||<|0.0001|TWO_SIDED|95.0|-24.48|-8.85||Two-sided p-value|Mixed-effects model repeated measures||Levodopa-Carbidopa Intestinal Gel (LCIG) - Optimized Medical Treatment (OMT) at Week 12|If the primary efficacy variable was statistically significant, each of the secondary variables were to be tested using a fixed sequence as a gatekeeping procedure and at α level of 0.050. Testing was to cease at the point that a secondary variable failed to demonstrate statistical significance.||-8.85|-24.48|<0.0001
72621196|NCT02732145|144773185|SUPERIORITY|Question: Is there a difference in the frequency of worsening of vulvar discomfort between two menstrual bleeding in symptomatic patients of reproductive age?||||||0.5307|||||||Chi-squared|||Parameter: The difference in the frequency of worsening of vulvar discomfort between two menstrual bleeding in symptomatic patients of reproductive age.||||0.5307
72621197|NCT02732145|144773185|SUPERIORITY|Question: Is there a difference in the frequency of worsening of vulvar discomfort during urination?||||||0.1546|||||||Chi-squared|||Parameter: The difference in the frequency of worsening of vulvar discomfort during urination.||||0.1546
72463545|NCT03873038|144449764|OTHER||GMR|0.68|||||TWO_SIDED|90.0|0.52|0.87|||||GMR=GM ESRD/GM Healthy|GMR was derived using GM for participants with ESRD and the GM from historical data obtained from a study of MK-2060 in healthy participants (PN001).||0.87|0.52|
72463546|NCT03873038|144449764|OTHER||GMR|0.78|||||TWO_SIDED|90.0|0.6|1.03|||||GMR=GM ESRD/GM Healthy|GMR was derived using GM for participants with ESRD and the GM from historical data obtained from a study of MK-2060 in healthy participants (PN001).||1.03|0.60|
72463547|NCT03873038|144449765|OTHER||GMR|1.5|||||TWO_SIDED|90.0|1.05|2.14|||||GMR=GM ESRD/GM Healthy|GMR was derived using GM for participants with ESRD and the GM from historical data obtained from a study of MK-2060 in healthy participants (PN001).||2.14|1.05|
72463548|NCT03873038|144449765|OTHER||GMR|0.91|||||TWO_SIDED|90.0|0.67|1.25|||||GMR=GM ESRD/GM Healthy|GMR was derived using GM for participants with ESRD and the GM from historical data obtained from a study of MK-2060 in healthy participants (PN001).||1.25|0.67|
72463549|NCT03873038|144449765|OTHER||GMR|0.86|||||TWO_SIDED|90.0|0.62|1.2|||||GMR=GM ESRD/GM Healthy|GMR was derived using GM for participants with ESRD and the GM from historical data obtained from a study of MK-2060 in healthy participants (PN001).||1.20|0.62|
72463550|NCT00595764|144449780|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.16|STANDARD_ERROR_OF_MEAN|1.4||0.91|TWO_SIDED|95.0|||||ANOVA|||With an effect size of 0.46, a sample size of 140 will provide a power of \>.84 with p\<.05 to detect overall differences between the two treatments on the primary outcome measures.||||.91
72463551|NCT00595764|144449782|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.4|STANDARD_ERROR_OF_MEAN|1.32||0.29|TWO_SIDED|95.0|||||t-test, 2 sided|||||||.29
72463552|NCT00595764|144449783|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.04|STANDARD_ERROR_OF_MEAN|0.029||0.58|TWO_SIDED|95.0|||||Mixed Models Analysis|Mixed Model Analysis to evaluate interaction of group by time.||||||.58
72463553|NCT00595764|144449784|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.38|STANDARD_ERROR_OF_MEAN|3.63||0.24|TWO_SIDED|95.0|||||Mixed Models Analysis|Mixed Model Analysis to evaluate interaction of group by time.||||||.24
72463554|NCT01332318|144449785|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.15|STANDARD_ERROR_OF_MEAN|0.06||||95.0|0.08|0.42|||||An Analysis of Covariance (ANCOVA) model, including terms for treatment, pooled study site, visit, and treatment by visit interaction, was used to calculate the adjusted mean difference and confidence interval. Arm 2 minus Arm 1.|||0.42|0.08|
72463555|NCT01332318|144449785|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.15|STANDARD_ERROR_OF_MEAN|0.06||||95.0|0.09|0.41|||||An Analysis of Covariance (ANCOVA) model, including terms for treatment, pooled study site, visit, and treatment by visit interaction, was used to calculate the adjusted mean difference and confidence interval. Arm 3 minus Arm 1.|||0.41|0.09|
72463556|NCT01332318|144449785|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.16|STANDARD_ERROR_OF_MEAN|0.06||||95.0|0.09|0.42|||||An Analysis of Covariance (ANCOVA) model, including terms for treatment, pooled study site, visit, and treatment by visit interaction, was used to calculate the adjusted mean difference and confidence interval. Arm 4 minus Arm 1.|||0.42|0.09|
72463557|NCT02820298|144449815|EQUIVALENCE|The acceptance range for bioequivalence is 80.0 - 125.00%.|Ratio of Geometric LSM|131.41|||||TWO_SIDED|90.0|117.03|147.56|||||Ratio of Geometric LSM is the ratio of exponentiated mean difference of log-transformed PK parameter. Confidence interval from ANOVA (linear mixed-effects model) with treatment, period, and sequence as fixed effects, and subject as a random effect.|||147.56|117.03|
72463558|NCT02820298|144449817|EQUIVALENCE|The acceptance range for bioequivalence is 80.0 - 125.00%.|Ratio of Geometric LSM|110.29|||||TWO_SIDED|90.0|103.91|117.06|||||Ratio of Geometric LSM is the ratio of exponentiated mean difference of log-transformed PK parameter. Confidence interval from ANOVA (linear mixed-effects model) with treatment, period, and sequence as fixed effects, and subject as a random effect.|||117.06|103.91|
72463559|NCT02820298|144449818|EQUIVALENCE|The acceptance range for bioequivalence is 80.0 - 125.00%.|Ratio of Geometric LSM|108.34|||||TWO_SIDED|90.0|102.48|114.54|||||Ratio of Geometric LSM is the ratio of exponentiated mean difference of log-transformed PK parameter. Confidence interval from ANOVA (linear mixed-effects model) with treatment, period, and sequence as fixed effects, and subject as a random effect.|||114.54|102.48|
72463560|NCT01894256|144449820|SUPERIORITY_OR_OTHER||Geometric least squares means ratio|1.15|||||TWO_SIDED|90.0|1.04|1.27|||||GLS mean for Mild Renal Impairment group vs GLS mean for Normal Renal Function|Null hypothesis: There are no clinically significant differences in the PK of olaparib when administered to patients with moderate or mild renal impairment compared to patients with normal renal function.||1.27|1.04|
72463561|NCT01894256|144449820|SUPERIORITY_OR_OTHER||Geometric least squares means ratio|1.26|||||TWO_SIDED|90.0|1.06|1.48|||||GLS mean for Moderate Renal Impairment group vs GLS mean for Normal Renal Function|Null hypothesis: There are no clinically significant differences in the PK of olaparib when administered to patients with moderate or mild renal impairment compared to patients with normal renal function.||1.48|1.06|
72463562|NCT01894256|144449821|SUPERIORITY_OR_OTHER||Geometric least squares means ratio|1.24|||||TWO_SIDED|90.0|1.06|1.47|||||GLS mean for Mild Renal Impairment group vs GLS mean for Normal Renal Function|Null hypothesis: There are no clinically significant differences in the PK of olaparib when administered to patients with moderate or mild renal impairment compared to patients with normal renal function.||1.47|1.06|
72463563|NCT01894256|144449821|SUPERIORITY_OR_OTHER||Geometric least squares means ratio|1.44|||||TWO_SIDED|90.0|1.1|1.89|||||GLS mean for Moderate Renal Impairment group vs GLS mean for Normal Renal Function|Null hypothesis: There are no clinically significant differences in the PK of olaparib when administered to patients with moderate or mild renal impairment compared to patients with normal renal function.||1.89|1.10|
72463564|NCT01780584|144449832|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.0|STANDARD_ERROR_OF_MEAN|0.8|<|0.05|TWO_SIDED|95.0|1.0|3.0||Repeated Anova was used to determine whether there was difference of FT3 levels between groups|ANOVA|||Null hypothesis: no difference of free T3 (FT3) levels will be found between placebo, low dose and high dose group. We anticipated a difference of 2 pg/ml in FT3 with a standard deviation of 0.8 pg/ml between groups. For a statistical power of 80% to identify a treatment effect and at a level significance of 0.05 (2-sided).||3|1|<0.05
72502115|NCT02799381|144534306|SUPERIORITY|The likelihood-based mixed-effects model repeated measures (MMRM) analysis of the change from baseline to Week 12 used all observed data. The model included fixed, categorical effects for treatment, country, visit, and treatment-by-visit interaction, with continuous fixed covariates for baseline score and the baseline score-by-visit interaction.|LS Mean Difference|-2.11|||<|0.0001|TWO_SIDED|95.0|-2.78|-1.44||Two-sided p-value|Mixed-effects model repeated measures||Levodopa-Carbidopa Intestinal Gel (LCIG) - Optimized Medical Treatment (OMT) at Week 12|If the primary efficacy variable was statistically significant, each of the secondary variables were to be tested using a fixed sequence as a gatekeeping procedure and at α level of 0.050. Testing was to cease at the point that a secondary variable failed to demonstrate statistical significance.||-1.44|-2.78|<0.0001
72463565|NCT01780584|144449834|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|5.0||||0.31||95.0|3.0|10.0||Kruskal Wallis test was used to determine any difference of time of extubation between groups.|Kruskal-Wallis|||Null hypothesis: no difference of time to extubation between group. Statistical power 80% and level of significance 0.05||10|3|0.31
72504816|NCT03114969|144540517|SUPERIORITY||Odds Ratio (OR)|1.591||||0.33|TWO_SIDED|95.0|0.625|4.05||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.|||4.050|0.625|0.330
72621198|NCT02732145|144773185|SUPERIORITY|Question: Is there a difference in the frequency of worsening of vulvar complaints during urination after sexual intercourse in symptomatic patients, who are sexually active?||||||0.1019|||||||Chi-squared|||Parameter: The difference in the frequency of worsening of vulvar complaints during urination after sexual intercourse in symptomatic patients, who are sexually active.||||0.1019
72621199|NCT02732145|144773186|EQUIVALENCE|Question: Is there a difference in the incidence of problems associated with urination and defecation between patients from different groups?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of problems associated with urination and defecation between patients from different groups.||||0.0000
72621200|NCT02732145|144773186|EQUIVALENCE|Question: Is there a difference in the incidence of dysuria between patients from different groups?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of dysuria between patients from different groups.||||0.0000
72463566|NCT01780584|144449835|SUPERIORITY_OR_OTHER||Median Difference (Net)|50.0||||0.4||95.0|40.0|60.0|||Kruskal-Wallis|||Null hypothesis: there is no difference of length of stay in Intensive Care Unit. Statistical power 80% and level of significance 0.05.||60|40|0.4
72463567|NCT01780584|144449836|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|10.0||||0.06||95.0|5.0|15.0|||Kruskal-Wallis|||Null hypothesis: there is no difference of postoperative hospital length of stay between groups. Statistical power 80% and level of significance 0.05.||15|5|0.06
72463568|NCT04783519|144449837|SUPERIORITY|Regression model with TIME × CONDITION Interactions, with AOC as reference category was run using sample of N=150.|beta coefficient|-0.39||||0.004|TWO_SIDED|95.0|-0.65|-0.127|||Regression, Linear|Models control for age, sex, race, and ethnicity.||Changes from Baseline to Post Assessment for BASICS+SLEEP vs. AOC reported in this section.||-0.127|-0.650|.004
72463569|NCT04783519|144449837|SUPERIORITY|Regression model with TIME × CONDITION Interactions, with AOC as reference category was run using sample of N=150.|beta coefficient|-0.21||||0.118|TWO_SIDED|95.0|-0.482|0.054|||Regression, Linear|Models control for age, sex, race, and ethnicity.||Changes from Baseline to Post Assessment for BASICS vs. AOC reported in this section.||.054|-.482|.118
72463570|NCT04783519|144449837|SUPERIORITY|Regression model with TIME × CONDITION Interactions, with AOC as reference category was run using sample of N=150.|beta coefficient|-0.41||||0.003|TWO_SIDED|95.0|-0.674|-0.142|||Regression, Linear|Models control for age, sex, race, and ethnicity.||Changes from Baseline to 3 Month Follow-up for BASICS+SLEEP vs. AOC reported in this section.||-0.142|-0.674|.003
72463571|NCT04783519|144449837|SUPERIORITY||beta coefficient|-0.16||||0.24|TWO_SIDED|95.0|-0.428|0.107|||Regression, Linear|Models control for age, sex, race, and ethnicity.||Changes from Baseline to 3 Month Follow-up for BASICS vs. AOC reported in this section.||0.107|-0.428|.240
72463572|NCT04783519|144449838|SUPERIORITY|Regression model with TIME × CONDITION Interactions, with AOC as reference category was run using sample of N=150.|beta coefficient|-4.88||||0.003|TWO_SIDED|95.0|-8.1|-1.65|||Regression, Linear|Models control for age, sex, race, and ethnicity.||Changes from Baseline to Post Assessment for BASICS+SLEEP vs. AOC reported in this section.||-1.65|-8.10|.003
72463573|NCT04783519|144449838|SUPERIORITY|Regression model with TIME × CONDITION Interactions, with AOC as reference category was run using sample of N=150.|beta coefficient|-1.71||||0.308|TWO_SIDED|95.0|-4.98|1.57|||Regression, Linear|Models control for age, sex, race, and ethnicity.||"Changes from Baseline to Post Assessment for BASICS vs. AOC reported in this section.~Score on measure (T-score method https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3261577/)"||1.57|-4.98|.308
72463574|NCT04783519|144449838|SUPERIORITY|Regression model with TIME × CONDITION Interactions, with AOC as reference category was run using sample of N=150.|beta coefficient|-4.52||||0.007|TWO_SIDED|95.0|-7.8|-1.25|||Regression, Linear|Models control for age, sex, race, and ethnicity.||"Changes from Baseline to 3 Month for BASICS+SLEEP vs. AOC reported in this section.~Score on measure (T-score method https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3261577/)"||-1.25|-7.8|.007
72463575|NCT04783519|144449838|SUPERIORITY|Regression model with TIME × CONDITION Interactions, with AOC as reference category was run using sample of N=150.|beta coefficient|-0.83||||0.621|TWO_SIDED|95.0|-4.12|2.46|||Regression, Linear|Models control for age, sex, race, and ethnicity.||Changes from Baseline to 3 Month for BASICS vs. AOC reported in this section. Score on measure (T-score method https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3261577/ )||2.46|-4.12|.621
72463576|NCT04783519|144449839|SUPERIORITY|Regression model with TIME × CONDITION Interactions, with AOC as reference category was run using sample of N=150.|count/rate ratio|0.802||||0.054|TWO_SIDED|95.0|0.641|1.003|||Mixed Models Analysis|Models control for age, sex, race, and ethnicity. Negative binomial model to address overdispersion.||Changes from Baseline to Post Assessment for BASICS+SLEEP vs. AOC reported in this section.||1.003|0.641|.054
72463577|NCT04783519|144449839|SUPERIORITY|Regression model with TIME × CONDITION Interactions, with AOC as reference category was run using sample of N=150.|count/rate ratio|0.75||||0.015|TWO_SIDED|95.0|0.6|0.946|||Generalized linear mixed model|Models control for age, sex, race, and ethnicity. Negative binomial model to address overdispersion.||Changes from Baseline to Post Assessment for BASICS vs. AOC reported in this section.||0.946|0.600|.015
72463578|NCT04783519|144449839|SUPERIORITY|Regression model with TIME × CONDITION Interactions, with AOC as reference category was run using sample of N=150.|count/rate ratio|0.736||||0.013|TWO_SIDED|95.0|0.578|0.937|||Generalized linear mixed model|Models control for age, sex, race, and ethnicity. Negative binomial model to address overdispersion.||Changes from Baseline to 3 Month Follow-up for BASICS+SLEEP vs. AOC reported in this section.||0.937|0.578|.013
72463579|NCT04783519|144449839|SUPERIORITY|Regression model with TIME × CONDITION Interactions, with AOC as reference category was run using sample of N=150.|count/rate ratio|0.658||||0.001|TWO_SIDED|95.0|0.513|0.844|||Generalized linear mixed model|Models control for age, sex, race, and ethnicity. Negative binomial model to address overdispersion.||Changes from Baseline to 3 Month Follow-up for BASICS vs. AOC reported in this section.||0.844|0.513|.001
72563839|NCT05918822|144659039|OTHER|A mixed-effects model was applied to ln-transformed plasma maribavir AUC0-infinity with treatment as a fixed effect, and participant as a random effect. Point estimates and their associated 90% CIs were constructed for the differences between Treatment E (test) versus Treatment D (reference). The point estimates and their associated 90% CIs were then back transformed to provide point estimates and 90% CIs for the ratios of Treatment E versus Treatment D.|Geometric Mean Ratio (GMR) (%)|88.92|||||TWO_SIDED|90.0|76.94|102.78|||||GMR (%) was calculated as 100\*(Test/Reference).|Comparison of AUC0-infinity of Maribavir: Part 2: Treatment E (Test) versus Treatment D (Reference)||102.78|76.94|
72621201|NCT02732145|144773186|EQUIVALENCE|Question: Is there a difference in the incidence of intermittent dysuria between patients from different groups?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of intermittent dysuria between patients from different groups.||||0.0000
72621202|NCT02732145|144773186|EQUIVALENCE|Question: Is there a difference in the incidence of frequent dysuria between patients from different groups?||||||0.0003|||||||Chi-squared|||Parameter: The difference in the incidence of frequent dysuria between patients from different groups.||||0.0003
72621203|NCT02732145|144773186|EQUIVALENCE|Question: Is there a difference in the incidence of urinary incontinence between patients from different groups?||||||0.001|||||||Chi-squared|||Parameter: The difference in the incidence of urinary incontinence between patients from different groups.||||0.0010
72393715|NCT03975790|144294222|SUPERIORITY|||||||0.088|||||||Chi-squared|||||||0.0880
72463580|NCT04783519|144449840|SUPERIORITY|Regression model with TIME × CONDITION Interactions, with AOC as reference category was run using sample of N=150.|count/rate ratio|0.992||||0.96|TWO_SIDED|95.0|0.716|1.374|||Generalized linear mixed model|Models control for age, sex, race, and ethnicity. Poisson model to address overdispersion (Negative binomial would not converge).||Changes from Baseline to Post Assessment for BASICS+SLEEP vs. AOC reported in this section.||1.374|0.716|.960
72463581|NCT04783519|144449840|SUPERIORITY|Regression model with TIME × CONDITION Interactions, with AOC as reference category was run using sample of N=150.|count/rate ratio|0.782||||0.152|TWO_SIDED|95.0|0.506|1.094|||Generalized linear mixed model|Models control for age, sex, race, and ethnicity. Poisson model to address overdispersion (Negative binomial would not converge).||Changes from Baseline to Post Assessment for BASICS vs. AOC reported in this section.||1.094|0.506|.152
72463582|NCT04783519|144449840|SUPERIORITY|Regression model with TIME × CONDITION Interactions, with AOC as reference category was run using sample of N=150.|count/rate ratio|0.887||||0.482|TWO_SIDED|95.0|0.634|1.24|||Generalized linear mixed model|Models control for age, sex, race, and ethnicity. Poisson model to address overdispersion (Negative binomial would not converge).||Changes from Baseline to 3 Month Follow-up for BASICS+SLEEP vs. AOC reported in this section.||1.240|0.634|.482
72463583|NCT04783519|144449840|SUPERIORITY|Regression model with TIME × CONDITION Interactions, with AOC as reference category was run using sample of N=150.|count/rate ratio|0.67||||0.02|TWO_SIDED|95.0|0.634|1.24|||Generalized linear mixed model|Models control for age, sex, race, and ethnicity. Poisson model to address overdispersion (Negative binomial would not converge).||Changes from Baseline to 3 Month Follow-up for BASICS vs. AOC reported in this section.||1.240|0.634|.020
72563840|NCT01796964|144659043|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority at week 12 is concluded at one-sided alpha level of 0.10 if the lower limit of the corresponding two-sided 80% confidence interval for the treatment difference (ESBA 1008 - EYLEA) is greater than -5 letters.|Treatment difference (ESBA - Eylea)|-1.13|||||TWO_SIDED|80.0|-4.19|1.93|||||Treatment differences were based on least squares estimates.|An analysis of variance (ANOVA) model with treatment and baseline BCVA categories (\< 55 and ≥ 55 letters) as class variables was used to estimate the treatment group differences (ESBA1008 - EYLEA) in the primary efficacy endpoint, BCVA Change from baseline to Week 12.||1.93|-4.19|
72463584|NCT04783519|144449841|SUPERIORITY|Regression model with TIME × CONDITION Interactions, with AOC as reference category was run using sample of N=150.|count/rate ratio|0.724||||0.032|TWO_SIDED|95.0|0.54|0.973|||Generalized linear mixed model|Models control for age, sex, race, and ethnicity. Negative binomial model to address overdispersion.||Changes from Baseline to 3 Month Follow-up for BASICS+SLEEP vs. AOC reported in this section.||0.973|0.540|.032
72463585|NCT04783519|144449841|SUPERIORITY|Regression model with TIME × CONDITION Interactions, with AOC as reference category was run using sample of N=150.|count/rate ratio|0.588|||<|0.001|TWO_SIDED|95.0|0.432|0.8|||Generalized linear mixed model|Models control for age, sex, race, and ethnicity. Negative binomial model to address overdispersion.||Changes from Baseline to 3 Month Follow-up for BASICS vs. AOC reported in this section.||0.800|0.432|<.001
72463586|NCT04783519|144449842|SUPERIORITY|Regression model with TIME × CONDITION Interactions, with AOC as reference category was run using sample of N=150.|count/rate ratio|0.699||||0.009|TWO_SIDED|95.0|0.535|0.914|||Generalized linear mixed model|Models control for age, sex, race, and ethnicity. Poisson model to address overdispersion (Negative binomial would not converge).||Changes from Baseline to Post Assessment for BASICS+SLEEP vs. AOC reported in this section.||0.914|0.535|.009
72463587|NCT04783519|144449842|SUPERIORITY|Regression model with TIME × CONDITION Interactions, with AOC as reference category was run using sample of N=150.|count/rate ratio|0.675||||0.005|TWO_SIDED|95.0|0.512|0.888|||Generalized linear mixed model|Models control for age, sex, race, and ethnicity. Poisson model to address overdispersion (Negative binomial would not converge).||Changes from Baseline to Post Assessment for BASICS vs. AOC reported in this section.||0.888|0.512|.005
72463588|NCT04783519|144449842|SUPERIORITY|Regression model with TIME × CONDITION Interactions, with AOC as reference category was run using sample of N=150.|count/rate ratio|0.698||||0.013|TWO_SIDED|95.0|0.526|0.928|||Generalized linear mixed model|Models control for age, sex, race, and ethnicity. Poisson model to address overdispersion (Negative binomial would not converge).||Changes from Baseline to 3 Month Follow-up for BASICS+SLEEP vs. AOC reported in this section.||0.928|0.526|.013
72463589|NCT04783519|144449842|SUPERIORITY|Regression model with TIME × CONDITION Interactions, with AOC as reference category was run using sample of N=150.|count/rate ratio|0.525|||<|0.001|TWO_SIDED|95.0|0.385|0.715|||Generalized linear mixed model|Models control for age, sex, race, and ethnicity. Poisson model to address overdispersion (Negative binomial would not converge).||Changes from Baseline to 3 Month Follow-up for BASICS vs. AOC reported in this section.||0.715|0.385|<.001
72463590|NCT04783519|144449843|SUPERIORITY|Regression model with TIME × CONDITION Interactions, with AOC as reference category was run using sample of N=150.|count/rate ratio|0.598||||0.01|TWO_SIDED|95.0|0.404|0.885|||Generalized linear mixed model|Models control for age, sex, race, and ethnicity. Poisson model to address overdispersion (Negative binomial would not converge).||Changes from Baseline to Post Assessment for BASICS+SLEEP vs. AOC reported in this section.||0.885|0.404|.010
72463591|NCT04783519|144449843|SUPERIORITY|Regression model with TIME × CONDITION Interactions, with AOC as reference category was run using sample of N=150.|count/rate ratio|0.502||||0.001|TWO_SIDED|95.0|0.331|0.76|||Generalized linear mixed model|Models control for age, sex, race, and ethnicity. Poisson model to address overdispersion (Negative binomial would not converge).||Changes from Baseline to Post Assessment for BASICS vs. AOC reported in this section.||0.760|0.331|.001
72463592|NCT04783519|144449843|SUPERIORITY|Regression model with TIME × CONDITION Interactions, with AOC as reference category was run using sample of N=150.|count/rate ratio|0.516||||0.002|TWO_SIDED|95.0|0.337|0.79|||Generalized linear mixed model|Models control for age, sex, race, and ethnicity. Poisson model to address overdispersion (Negative binomial would not converge).||Changes from Baseline to 3 Month Follow-up for BASICS+SLEEP vs. AOC reported in this section.||0.790|0.337|.002
72463593|NCT04783519|144449843|SUPERIORITY|Regression model with TIME × CONDITION Interactions, with AOC as reference category was run using sample of N=150.|count/rate ratio|0.506||||0.002|TWO_SIDED|95.0|0.33|0.774|||Generalized linear mixed model|Models control for age, sex, race, and ethnicity. Poisson model to address overdispersion (Negative binomial would not converge).||Changes from Baseline to 3 Month Follow-up for BASICS vs. AOC reported in this section.||0.774|0.330|.002
72463594|NCT04783519|144449844|SUPERIORITY|Regression model with TIME × CONDITION Interactions, with AOC as reference category.|count/rate ratio|0.628||||0.003|TWO_SIDED|95.0|0.462|0.853|||Generalized linear mixed model|Models control for age, sex, race, and ethnicity. Negative binomial model to address overdispersion.||Changes from Baseline to Post Assessment for BASICS+SLEEP vs. AOC reported in this section.||0.853|0.462|.003
72463595|NCT04783519|144449844|SUPERIORITY|Regression model with TIME × CONDITION Interactions, with AOC as reference category.|count/rate ratio|0.744||||0.073|TWO_SIDED|95.0|0.538|1.028|||Generalized linear mixed model|Models control for age, sex, race, and ethnicity. Negative binomial model to address overdispersion.||Changes from Baseline to Post Assessment for BASICS vs. AOC reported in this section.||1.028|0.538|.073
72463596|NCT04783519|144449844|SUPERIORITY|Regression model with TIME × CONDITION Interactions, with AOC as reference category.|count/rate ratio|0.764||||0.09|TWO_SIDED|95.0|0.559|1.043|||Generalized linear mixed model|Models control for age, sex, race, and ethnicity. Negative binomial model to address overdispersion.||Changes from Baseline to Post Assessment for BASICS+SLEEP vs. AOC reported in this section.||1.043|0.559|.090
72463597|NCT04783519|144449844|SUPERIORITY|Regression model with TIME × CONDITION Interactions, with AOC as reference category.|count/rate ratio|0.656||||0.013|TWO_SIDED|95.0|0.469|0.916|||Generalized linear mixed model|Models control for age, sex, race, and ethnicity. Negative binomial model to address overdispersion.||Changes from Baseline to Post Assessment for BASICS vs. AOC reported in this section.||0.916|0.469|.013
72463598|NCT04783519|144449845|SUPERIORITY|Regression model with TIME × CONDITION Interactions, with AOC as reference category was run using sample of N=150.|count/rate ratio|0.753||||0.087|TWO_SIDED|95.0|0.546|1.041|||Generalized linear mixed model|Model controls for age, sex, race, and ethnicity. Negative binomial model to address overdispersion.||Changes from Baseline to Post Assessment for BASICS+SLEEP vs. AOC reported in this section.||1.041|0.546|.087
72463599|NCT04783519|144449845|SUPERIORITY|Regression model with TIME × CONDITION Interactions, with AOC as reference category was run using sample of N=150.|count/rate ratio|0.739||||0.078|TWO_SIDED|95.0|0.528|1.034|||Generalized linear mixed model|Model controls for age, sex, race, and ethnicity. Negative binomial model to address overdispersion.||Changes from Baseline to Post Assessment for BASICS vs. AOC reported in this section.||1.034|0.528|.078
72463600|NCT04783519|144449845|SUPERIORITY|Regression model with TIME × CONDITION Interactions, with AOC as reference category was run using sample of N=150.|count/rate ratio|0.773||||0.099|TWO_SIDED|95.0|0.569|1.05|||Generalized linear mixed model|Models control for age, sex, race, and ethnicity. Negative binomial model to address overdispersion.||Changes from Baseline to 3 Month Follow-up for BASICS+SLEEP vs. AOC reported in this section.||1.050|0.569|.099
72463601|NCT04783519|144449845|SUPERIORITY|Regression model with TIME × CONDITION Interactions, with AOC as reference category was run using sample of N=150.|count/rate ratio|0.704||||0.031|TWO_SIDED|95.0|0.512|0.969|||Generalized linear mixed model|Model controls for age, sex, race, and ethnicity. Negative binomial model to address overdispersion.||Changes from Baseline to 3 Month Follow-up for BASICS vs. AOC reported in this section.||0.969|0.512|.031
72463602|NCT00645099|144449859|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon (Mann-Whitney)|This test was interpreted at the 5% significance level (2-tailed).||Based on available data it was estimated that in the paliperidone ER group the TG:HDL ratio would decrease with 0.15 and that the TG:HDL ratio would increase with 0.25 in the olanzapine group. The common SD of the change was estimated to be 1.4. A sample size of 205 patients in each treatment arm had 80% power to detect a difference of 0.4 in change of TG:HDL ratio after 6 months of treatment in favor of paliperidone ER treatment (Wilcoxon two-sample test with 0.05 two-sided significance level).||||< 0.0001
72463603|NCT00645099|144449859|SUPERIORITY_OR_OTHER|||||||0.4718||95.0|||||Wilcoxon signed rank test|This test was interpreted at the 5% significance level (2-tailed).||Within-group comparison of the change from baseline at end point.||||0.4718
72463604|NCT00645099|144449859|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon signed rank test|This test was interpreted at the 5% significance level (2-tailed).||Within-group change from baseline at end point.||||< 0.0001
72463605|NCT00645099|144449860|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon (Mann-Whitney)|This test was interpreted at the 5% significance level (2-tailed).||||||<0.0001
72463606|NCT00645099|144449860|SUPERIORITY_OR_OTHER|||||||0.9143||95.0|||||Wilcoxon signed rank test|This test was interpreted at the 5% significance level (2-tailed).||Within-group change from baseline to end point.||||0.9143
72393716|NCT03975790|144294222|SUPERIORITY||||||<|0.0001|||||||Chi-squared|||||||<0.0001
72463607|NCT00645099|144449860|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon signed rank test|This test was interpreted at the 5% significance level (2-tailed).||Within-group change from baseline to end point.||||<0.0001
72463608|NCT00645099|144449861|SUPERIORITY_OR_OTHER|||||||0.005||95.0|||||Wilcoxon (Mann-Whitney)|This test was interpreted at the 5% significance level (2-tailed).||||||0.0050
72463609|NCT00645099|144449861|SUPERIORITY_OR_OTHER|||||||0.4454||95.0|||||Wilcoxon signed rank test|This test was interpreted at the 5% significance level (2-tailed).||Within-group change from baseline to end point.||||0.4454
72463610|NCT00645099|144449861|SUPERIORITY_OR_OTHER|||||||0.0018||95.0|||||Wilcoxon signed rank test|This test was interpreted at the 5% significance level (2-tailed).||Within-group change from baseline to end point.||||0.0018
72463611|NCT00645099|144449862|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon (Mann-Whitney)|This test was interpreted at the 5% significance level (2-tailed).||||||<0.0001
72463612|NCT00645099|144449863|SUPERIORITY_OR_OTHER|||||||0.0004||95.0|||||Wilcoxon (Mann-Whitney)|This test was interpreted at the 5% significance level (2-tailed).||||||0.0004
72463613|NCT00645099|144449864|SUPERIORITY_OR_OTHER|||||||0.0272||95.0|||||Wilcoxon (Mann-Whitney)|This test was interpreted at the 5% significance level (2-tailed).||||||0.0272
72463614|NCT00645099|144449865|SUPERIORITY_OR_OTHER|||||||0.1892||95.0|||||Wilcoxon (Mann-Whitney)|This test was interpreted at the 5% significance level (2-tailed).||||||0.1892
72463615|NCT00645099|144449866|SUPERIORITY_OR_OTHER|||||||0.0325||95.0|||||Wilcoxon (Mann-Whitney)|This test was interpreted at the 5% significance level (2-tailed).||||||0.0325
72463616|NCT00645099|144449867|SUPERIORITY_OR_OTHER|||||||0.1117||95.0|||||Wilcoxon (Mann-Whitney)|This test was interpreted at the 5% significance level (2-tailed).||||||0.1117
72463617|NCT00645099|144449868|SUPERIORITY_OR_OTHER|||||||0.6346||95.0|||||Fisher Exact|This test was interpreted at the 5% significance level (2-tailed).||||||0.6346
72463618|NCT00645099|144449869|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|This test was interpreted at the 5% significance level (2-tailed).||||||1.0000
72563841|NCT01796964|144659044|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority at week 16 is concluded at one-sided alpha level of 0.10 if the lower limit of the corresponding two-sided 80% confidence interval for the treatment difference (ESBA 1008 - EYLEA) is greater than -5 letters.|Treatment difference (ESBA - Eylea)|-0.58|||||TWO_SIDED|80.0|-3.72|2.56|||||Treatment differences were based on least squares estimates.|An analysis of variance (ANOVA) model with treatment and baseline BCVA categories (\< 55 and ≥ 55 letters) as class variables was used to estimate the treatment group differences (ESBA1008 - EYLEA) in the primary efficacy endpoint, BCVA Change from baseline to Week 16.||2.56|-3.72|
72463619|NCT00645099|144449870|SUPERIORITY_OR_OTHER|||||||0.677||95.0|||||Fisher Exact|This test was interpreted at the 5% significance level (2-tailed).||||||0.6770
72463620|NCT00645099|144449871|SUPERIORITY_OR_OTHER|||||||0.1308||95.0|||||Wilcoxon (Mann-Whitney)|This test was interpreted at the 5% significance level (2-tailed).||||||0.1308
72463621|NCT00645099|144449872|SUPERIORITY_OR_OTHER|||||||0.3358||95.0|||||Wilcoxon (Mann-Whitney)|This test was interpreted at the 5% significance level (2-tailed).||||||0.3358
72463622|NCT00645099|144449873|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon (Mann-Whitney)|This test was interpreted at the 5% significance level (2-tailed).||||||<0.0001
72463623|NCT00645099|144449873|SUPERIORITY_OR_OTHER|||||||0.0001||95.0|||||Wilcoxon signed rank test|This test was interpreted at the 5% significance level (2-tailed).||Within-group change from baseline to end point.||||0.0001
72621204|NCT02732145|144773186|EQUIVALENCE|Question: Is there a difference in the incidence of intermittent urinary incontinence between patients from different groups?||||||0.1859|||||||Chi-squared|||Parameter: The difference in the incidence of intermittent urinary incontinence between patients from different groups.||||0.1859
72463624|NCT00645099|144449873|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon signed rank test|This test was interpreted at the 5% significance level (2-tailed).||Within-group change from baseline to end point.||||< 0.0001
72463625|NCT00645099|144449874|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon (Mann-Whitney)|This test was interpreted at the 5% significance level (2-tailed).||||||<0.0001
72463626|NCT00645099|144449875|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon (Mann-Whitney)|This test was interpreted at the 5% significance level (2-tailed).||||||<0.0001
72393717|NCT03975790|144294222|SUPERIORITY|||||||0.0065|||||||Chi-squared|||||||0.0065
72393718|NCT03975790|144294223|SUPERIORITY|||||||0.5157|||||||Chi-squared|||||||0.5157
72463627|NCT00645099|144449876|SUPERIORITY_OR_OTHER|||||||0.023||95.0|||||Fisher Exact|This test was interpreted at the 5% significance level (2-tailed).||||||0.0230
72463628|NCT00645099|144449877|NON_INFERIORITY_OR_EQUIVALENCE|Testing non-inferiority of the paliperidone ER treatment group compared to the olanzapine treatment group, with regard to change versus baseline at end point of the total PANSS was done by means of Schuirmann's test. A difference of 6 points in change versus baseline on the total PANSS was considered to be a minimum clinically relevant difference.The null hypothesis is that there is no difference between paliperidone and olanzapine in change in TG:HDL ratio from baseline to endpoint.||||||0.0242||95.0|||||Schuirmann|The null hypothesis of non-equivalence was rejected and equivalence to within the specified equivalence bounds could be claimed.||||||0.0242
72463629|NCT00645099|144449877|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon signed rank test|This test was interpreted at the 5% significance level (2-tailed).||Within-group change from baseline to end point.||||<0.0001
72463630|NCT00645099|144449877|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon signed rank test|This test was interpreted at the 5% significance level (2-tailed).||Within-group change from baseline to end point.||||<0.0001
72463631|NCT01201915|144449878|SUPERIORITY_OR_OTHER|||||||0.8463|||||||1-sided exact binomial test|||The null hypothesis was that percentage of participants with complete histologic clearance was 50% or less.||||0.8463
72463632|NCT01201915|144449878|SUPERIORITY_OR_OTHER|||||||0.9668|||||||1-sided exact binomial test|||The null hypothesis was that percentage of participants with complete histologic clearance was 30% or less.||||0.9668
72463633|NCT01201915|144449878|SUPERIORITY_OR_OTHER|||||||0.7878|||||||1-sided exact binomial test|||The null hypothesis was that percentage of participants with complete histologic clearance was 50% or less.||||0.7878
72463634|NCT00663923|144449892|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.05|STANDARD_DEVIATION|0.1|<|0.05|TWO_SIDED|95.0|-0.62|-0.001||two - tailed p value \<0.05 were considered statistically significant.|t-test, 2 sided|in this study degrees of freedom is sample size - 1||||-.001|-.62|<0.05
72463635|NCT04380688|144449912|OTHER|No formal hypothesis testing for this endpoint.|Hazard Ratio (HR)|0.553|||||TWO_SIDED|90.0|0.145|1.952||P-value not generated.|Regression, Cox|Adjusting for age (\<65 vs \>=65 years) and comorbidities (present vs absent). Ties handled by Efron approach. HR CI using profile likelihood approach.||||1.952|0.145|
72463636|NCT04380688|144449920|OTHER|No formal hypothesis testing for this endpoint.|Hazard Ratio (HR)|1.314|||||TWO_SIDED|90.0|0.794|2.183||P-value not generated.|Regression, Cox|Adjusting for age (\<65 vs \>=65 years) and comorbidities (present vs absent). Ties handled by Efron approach. HR CI using profile likelihood approach.||||2.183|0.794|
72463637|NCT01967719|144449955|SUPERIORITY_OR_OTHER_LEGACY||Geometric LS Mean Ratio|56.57|||||TWO_SIDED|95.0|44.21|72.39|||ANOVA|The model included terms for sequence, subject nested within sequence, period, and product as fixed effect factors.|LS mean ratio (mTHS 2.2 - Group 1:mCC - Group 1)|The objective of this study was to determine the point estimate and precision of the nicotine bioavailability (ratio of mTHS 2.2:mCC) for Cmax, therefore, there was no statistical hypothesis to be tested for this objective.||72.39|44.21|
72463638|NCT01967719|144449956|SUPERIORITY_OR_OTHER_LEGACY||Geometric LS Mean Ratio|55.64|||||TWO_SIDED|95.0|43.3|71.5|||ANOVA|The model included terms for sequence, subject nested within sequence, period, and product as fixed effect factors.|LS mean ratio (mTHS 2.2 - Group 1:mCC - Group 1)|The objective of this study was to determine the point estimate and precision of the nicotine bioavailability (ratio of mTHS 2.2:mCC) for AUC(0-last), therefore, there was no statistical hypothesis to be tested for this objective.||71.50|43.30|
72393719|NCT03975790|144294223|SUPERIORITY|||||||0.1231|||||||Chi-squared|||||||0.1231
72393720|NCT03975790|144294223|SUPERIORITY|||||||0.2109|||||||Chi-squared|||||||0.2109
72393721|NCT03975790|144294224|SUPERIORITY|||||||0.8424|||||||Chi-squared|||||||0.8424
72393722|NCT03975790|144294224|SUPERIORITY|||||||0.3278|||||||Chi-squared|||||||0.3278
72393723|NCT03975790|144294224|SUPERIORITY|||||||0.3336|||||||Chi-squared|||||||0.3336
72463639|NCT00796614|144449957|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.38||||0.5388|TWO_SIDED|95.0|0.5|3.8|||Regression, Logistic|||Logistic regression model was used with treatment variable and three covariates: age group, concomitant use of anti-cholinergic medication and geographic region. The first two covariates were used in the stratification of the randomisation. On treatment (OT) analyses approach was used.||3.80|0.50|0.5388
72463640|NCT00796614|144449957|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.59||||0.343|TWO_SIDED|95.0|0.2|1.76|||Regression, Logistic|||Logistic regression model was used with treatment variable and three covariates: age group, concomitant use of anti-cholinergic medication and geographic region. The first two covariates were used in the stratification of the randomisation. On treatment (OT) analyses approach was used.||1.76|0.20|0.3430
72463641|NCT00796614|144449957|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.41||||0.5209|TWO_SIDED|95.0|0.5|3.97|||Regression, Logistic|||Logistic regression model was used with treatment variable and three covariates: age group, concomitant use of anti-cholinergic medication and geographic region. The first two covariates were used in the stratification of the randomisation. On treatment (OT) analyses approach was used.||3.97|0.50|0.5209
72393724|NCT03975790|144294225|SUPERIORITY|||||||0.0654|||||||Chi-squared|||||||0.0654
72463642|NCT00796614|144449957|SUPERIORITY_OR_OTHER|||||||0.9436|||||||Cochran-Armitage trend test|||A test of trend across the four treatment groups was performed as a secondary analysis in the proportion of responders across the dose levels using Cochran-Armitage trend test.||||0.9436
72463643|NCT00796614|144449958|SUPERIORITY_OR_OTHER|||||||0.3097|||||||ANCOVA|||ANCOVA model was used with covariates of age group, anti-cholinergic use at baseline and geographic region. On treatment (OT) analyses approach was used.||||0.3097
72393725|NCT03975790|144294225|SUPERIORITY|||||||0.7315|||||||Chi-squared|||||||0.7315
72393726|NCT03975790|144294225|SUPERIORITY|||||||0.1897|||||||Chi-squared|||||||0.1897
72393727|NCT03975790|144294226|SUPERIORITY|||||||0.5146|||||||Chi-squared|||||||0.5146
72393728|NCT03975790|144294226|SUPERIORITY|||||||0.7121|||||||Chi-squared|||||||0.7121
72393729|NCT03975790|144294226|SUPERIORITY|||||||0.4434|||||||Chi-squared|||||||0.4434
72393730|NCT03975790|144294227|SUPERIORITY|||||||0.8966|||||||Chi-squared|||||||0.8966
72393731|NCT03975790|144294227|SUPERIORITY|||||||0.2105|||||||Chi-squared|||||||0.2105
72393732|NCT03975790|144294227|SUPERIORITY|||||||0.3336|||||||Chi-squared|||||||0.3336
72393733|NCT03975790|144294229|SUPERIORITY|||||||0.361|||||||Chi-squared|||||||0.3610
72393734|NCT03975790|144294229|SUPERIORITY|||||||0.4519|||||||Chi-squared|||||||0.4519
72393735|NCT03975790|144294229|SUPERIORITY|||||||0.9612|||||||Chi-squared|||||||0.9612
72393736|NCT03975790|144294230|SUPERIORITY|||||||0.8135|||||||Chi-squared|||||||0.8135
72393737|NCT03975790|144294230|SUPERIORITY|||||||0.591|||||||Chi-squared|||||||0.5910
72393738|NCT03975790|144294230|SUPERIORITY|||||||0.7635|||||||Chi-squared|||||||0.7635
72393739|NCT03975790|144294231|SUPERIORITY|||||||0.597|||||||Chi-squared|||||||0.5970
72393740|NCT03975790|144294231|SUPERIORITY|||||||0.7055|||||||Chi-squared|||||||0.7055
72393741|NCT03975790|144294232|SUPERIORITY|||||||0.5435|||||||Chi-squared|||||||0.5435
72393742|NCT03975790|144294232|SUPERIORITY|||||||0.679|||||||Chi-squared|||||||0.6790
72393743|NCT03975790|144294232|SUPERIORITY|||||||0.9676|||||||Chi-squared|||||||0.9676
72393744|NCT03975790|144294233|SUPERIORITY|||||||0.8035|||||||Chi-squared|||||||0.8035
72393745|NCT03975790|144294233|SUPERIORITY|||||||0.4184|||||||Chi-squared|||||||0.4184
72393746|NCT03975790|144294233|SUPERIORITY|||||||0.395|||||||Chi-squared|||||||0.3950
72393747|NCT03975790|144294235|SUPERIORITY|||||||0.7871|||||||Chi-squared|||||||0.7871
72393748|NCT03975790|144294235|SUPERIORITY|||||||0.0722|||||||Chi-squared|||||||0.0722
72393749|NCT03975790|144294235|SUPERIORITY|||||||0.181|||||||Chi-squared|||||||0.1810
72393750|NCT03975790|144294236|SUPERIORITY|||||||0.1984|||||||Chi-squared|||||||0.1984
72393751|NCT03975790|144294236|SUPERIORITY|||||||0.2043|||||||Chi-squared|||||||0.2043
72393752|NCT03975790|144294236|SUPERIORITY|||||||0.0439|||||||Chi-squared|||||||0.0439
72393753|NCT03975790|144294237|SUPERIORITY|||||||0.1702|||||||Chi-squared|||||||0.1702
72393754|NCT03975790|144294237|SUPERIORITY|||||||0.5926|||||||Chi-squared|||||||0.5926
72393755|NCT03975790|144294237|SUPERIORITY|||||||0.3088|||||||Chi-squared|||||||0.3088
72393756|NCT03975790|144294238|SUPERIORITY|||||||0.9141|||||||Chi-squared|||||||0.9141
72393757|NCT03975790|144294238|SUPERIORITY|||||||0.7623|||||||Chi-squared|||||||0.7623
72393758|NCT03975790|144294238|SUPERIORITY|||||||0.8517|||||||Chi-squared|||||||0.8517
72393759|NCT03975790|144294239|SUPERIORITY|||||||0.1208|||||||Chi-squared|||||||0.1208
72393760|NCT03975790|144294239|SUPERIORITY|||||||0.0425|||||||Chi-squared|||||||0.0425
72393761|NCT03975790|144294239|SUPERIORITY|||||||0.0046|||||||Chi-squared|||||||0.0046
72393762|NCT03975790|144294240|SUPERIORITY|||||||0.8698|||||||t-test|||||||0.8698
72393763|NCT03975790|144294240|SUPERIORITY|||||||0.7391|||||||t-test|||||||0.7391
72393764|NCT03975790|144294240|SUPERIORITY|||||||0.7043|||||||t-test|||||||0.7043
72393765|NCT03975790|144294241|SUPERIORITY|||||||0.0536|||||||t-test|||||||0.0536
72393766|NCT03975790|144294241|SUPERIORITY|||||||0.9313|||||||t-test|||||||0.9313
72393767|NCT03975790|144294241|SUPERIORITY|||||||0.374|||||||t-test|||||||0.3740
72393768|NCT03975790|144294242|SUPERIORITY|||||||0.6963|||||||t-test|||||||0.6963
72393769|NCT03975790|144294242|SUPERIORITY|||||||0.9816|||||||t-test|||||||0.9816
72393770|NCT03975790|144294242|SUPERIORITY|||||||0.8349|||||||t-test|||||||0.8349
72463644|NCT00796614|144449958|SUPERIORITY_OR_OTHER|||||||0.2676|||||||ANCOVA|||ANCOVA model was used with covariates of age group, anti-cholinergic use at baseline and geographic region. On treatment (OT) analyses approach was used.||||0.2676
72463645|NCT00796614|144449958|SUPERIORITY_OR_OTHER|||||||0.6265|||||||ANCOVA|||ANCOVA model was used with covariates of age group, anti-cholinergic use at baseline and geographic region. On treatment (OT) analyses approach was used.||||0.6265
72463646|NCT00796614|144449959|SUPERIORITY_OR_OTHER|||||||0.4359|||||||ANCOVA|||ANCOVA model was used with covariates of age group, anti-cholinergic use at baseline and geographic region. On treatment (OT) analyses approach was used.||||0.4359
72463647|NCT00796614|144449959|SUPERIORITY_OR_OTHER|||||||0.0658|||||||ANCOVA|||ANCOVA model was used with covariates of age group, anti-cholinergic use at baseline and geographic region. On treatment (OT) analyses approach was used.||||0.0658
72463648|NCT00796614|144449959|SUPERIORITY_OR_OTHER|||||||0.6709|||||||ANCOVA|||ANCOVA model was used with covariates of age group, anti-cholinergic use at baseline and geographic region. On treatment (OT) analyses approach was used.||||0.6709
72463649|NCT00796614|144449960|SUPERIORITY_OR_OTHER|||||||0.5672|||||||Regression, Logistic|||Patient responded to tamsulosin-low dose (Left Kidney) was compared to placebo. Logistic regression model was used with age group, anti-cholinergic use, and geographic region as covariates. On treatment (OT) analyses approach was used.||||0.5672
72463650|NCT00796614|144449960|SUPERIORITY_OR_OTHER|||||||0.8724|||||||Regression, Logistic|||Patient responded to tamsulosin-medium dose (Left Kidney) was compared to placebo. Logistic regression model was used with age group, anti-cholinergic use, and geographic region as covariates. On treatment (OT) analyses approach was used.||||0.8724
72463651|NCT00796614|144449960|SUPERIORITY_OR_OTHER|||||||0.7674|||||||Regression, Logistic|||Patient responded to tamsulosin-high dose (Left Kidney) was compared to placebo. Logistic regression model was used with age group, anti-cholinergic use, and geographic region as covariates. On treatment (OT) analyses approach was used.||||0.7674
72463652|NCT00796614|144449960|SUPERIORITY_OR_OTHER|||||||0.5545|||||||Regression, Logistic|||Patient responded to tamsulosin-low dose (Right Kidney) was compared to placebo. Logistic regression model was used with age group, anti-cholinergic use, and geographic region as covariates. On treatment (OT) analyses approach was used.||||0.5545
72463653|NCT00796614|144449960|SUPERIORITY_OR_OTHER|||||||0.4774|||||||Regression, Logistic|||Patient responded to tamsulosin-Medium dose (Right Kidney) was compared to placebo. Logistic regression model was used with age group, anti-cholinergic use, and geographic region as covariates. On treatment (OT) analyses approach was used.||||0.4774
72463654|NCT00796614|144449960|SUPERIORITY_OR_OTHER|||||||0.8626|||||||Regression, Logistic|||Patient responded to tamsulosin-High dose (Right Kidney) was compared to placebo. Logistic regression model was used with age group, anti-cholinergic use,and geographic region as covariates. On treatment (OT) analyses approach was used.||||0.8626
72463655|NCT00796614|144449961|SUPERIORITY_OR_OTHER|||||||0.9669|||||||Regression, Logistic|||Patient responded to tamsulosin-low dose (Left Kidney) was compared to placebo. Logistic regression model was used with age group, anti-cholinergic use, and geographic region as covariates. On treatment (OT) analyses approach was used.||||0.9669
72463656|NCT00796614|144449961|SUPERIORITY_OR_OTHER|||||||0.9231|||||||Regression, Logistic|||Patient responded to tamsulosin-medium dose (Left Kidney) was compared to placebo. Logistic regression model was used with age group, anti-cholinergic use, and geographic region as covariates. On treatment (OT) analyses approach was used.||||0.9231
72463657|NCT00796614|144449961|SUPERIORITY_OR_OTHER|||||||0.636|||||||Regression, Logistic|||Patient responded to tamsulosin-high dose (Left Kidney) was compared to placebo. Logistic regression model was used with age group, anti-cholinergic use, and geographic region as covariates. On treatment (OT) analyses approach was used.||||0.6360
72463658|NCT00796614|144449961|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||Patient responded to tamsulosin-low dose (Right Kidney) was compared to placebo. Fisher's exact test was used for this analysis.||||1.0000
72463659|NCT00796614|144449961|SUPERIORITY_OR_OTHER|||||||0.4925|||||||Fisher Exact|||Patient responded to tamsulosin-medium dose (Right Kidney) was compared to placebo. Fisher's exact test was used for this analysis.||||0.4925
72463660|NCT00796614|144449961|SUPERIORITY_OR_OTHER|||||||0.4977|||||||Fisher Exact|||Patient responded to tamsulosin-high dose (Right Kidney) was compared to placebo. Fisher's exact test was used for this analysis.||||0.4977
72463661|NCT00796614|144449962|SUPERIORITY_OR_OTHER|||||||0.1373|||||||ANCOVA|||ANCOVA model was used with age group, anti-cholinergic use, and geographic region as covariates. On treatment (OT) analyses approach was used.||||0.1373
72463662|NCT00796614|144449962|SUPERIORITY_OR_OTHER|||||||0.744|||||||ANCOVA|||ANCOVA model was used with age group, anti-cholinergic use, and geographic region as covariates. On treatment (OT) analyses approach was used.||||0.7440
72463663|NCT00796614|144449962|SUPERIORITY_OR_OTHER|||||||0.7703|||||||ANCOVA|||ANCOVA model was used with age group, anti-cholinergic use, and geographic region as covariates. On treatment (OT) analyses approach was used.||||0.7703
72463664|NCT00796614|144449963|SUPERIORITY_OR_OTHER|||||||0.0808|||||||ANCOVA|||ANCOVA model was used with age group, anti-cholinergic use, and geographic region as covariates. On treatment (OT) analyses approach was used.||||0.0808
72463665|NCT00796614|144449963|SUPERIORITY_OR_OTHER|||||||0.8244|||||||ANCOVA|||ANCOVA model was used with age group, anti-cholinergic use, and geographic region as covariates. On treatment (OT) analyses approach was used.||||0.8244
72463666|NCT00796614|144449963|SUPERIORITY_OR_OTHER|||||||0.5045|||||||ANCOVA|||ANCOVA model was used with age group, anti-cholinergic use, and geographic region as covariates. On treatment (OT) analyses approach was used.||||0.5045
72463667|NCT03449134|144449968|OTHER||Estimated Percent Change Difference|-18.45||||0.041|TWO_SIDED|95.0|-32.92|-0.86||Comparison based on a longitudinal ANCOVA model that included treatment, visit, treatment-by-visit interaction, gender, region, log-transformed baseline value, and log-transformed baseline value-by-visit as covariates.|ANCOVA|||Estimated relative reduction (ERR) relative to Placebo (i.e. estimated percent change difference) was calculated by 100 (e\*\*DIFF -1), where e = exponent of difference; and DIFF= treatment difference in change from baseline at Week 12 based on log transformed data.||-0.86|-32.92|0.041
72463668|NCT03449134|144449968|OTHER||Estimated Percent Change Difference|1.56||||0.874|TWO_SIDED|95.0|-16.13|22.99||Comparison based on a longitudinal ANCOVA model that included treatment, visit, treatment-by-visit interaction, gender, region, log-transformed baseline value, and log-transformed baseline value-by-visit as covariates.|ANCOVA|||Estimated relative reduction (ERR) relative to Placebo (i.e. estimated percent change difference) was calculated by 100 (e\*\*DIFF -1), where e = exponent of difference; and DIFF= treatment difference in change from baseline at Week 12 based on log transformed data.||22.99|-16.13|0.874
72621205|NCT02732145|144773186|EQUIVALENCE|Question: Is there a difference in the incidence of frequent urinary incontinence between patients from different groups?||||||0.0003|||||||Chi-squared|||Parameter: The difference in the incidence of frequent urinary incontinence between patients from different groups.||||0.0003
72393771|NCT03975790|144294243|SUPERIORITY|||||||0.0003|||||||t-test|||||||0.0003
72393772|NCT03975790|144294243|SUPERIORITY|||||||0.9431|||||||t-test|||||||0.9431
72393773|NCT03975790|144294243|SUPERIORITY|||||||0.2964|||||||t-test|||||||0.2964
72393774|NCT03975790|144294244|SUPERIORITY|||||||0.2614|||||||t-test|||||||0.2614
72393775|NCT03975790|144294244|SUPERIORITY|||||||0.0014|||||||t-test|||||||0.0014
72393776|NCT03975790|144294244|SUPERIORITY|||||||0.0535|||||||t-test|||||||0.0535
72393777|NCT03975790|144294245|SUPERIORITY|||||||0.0051|||||||t-test|||1 months before index date||||0.0051
72393778|NCT03975790|144294245|SUPERIORITY|||||||0.3041|||||||t-test|||1 months before index date||||0.3041
72393779|NCT03975790|144294245|SUPERIORITY|||||||0.4432|||||||t-test|||1 months before index date||||0.4432
72393780|NCT03975790|144294245|SUPERIORITY|||||||0.8641|||||||t-test|||2 months before index date||||0.8641
72393781|NCT03975790|144294245|SUPERIORITY|||||||0.0435|||||||t-test|||2 months before index date||||0.0435
72393782|NCT03975790|144294245|SUPERIORITY|||||||0.153|||||||t-test|||2 months before index date||||0.1530
72393783|NCT03975790|144294245|SUPERIORITY|||||||0.1188|||||||t-test|||3 months before index date||||0.1188
72393784|NCT03975790|144294245|SUPERIORITY|||||||0.6807|||||||t-test|||3 months before index date||||0.6807
72393785|NCT03975790|144294245|SUPERIORITY|||||||0.1772|||||||t-test|||3 months before index date||||0.1772
72393786|NCT03975790|144294245|SUPERIORITY|||||||0.6104|||||||t-test|||4 months before index date||||0.6104
72393787|NCT03975790|144294245|SUPERIORITY|||||||0.9564|||||||t-test|||4 months before index date||||0.9564
72393788|NCT03975790|144294245|SUPERIORITY|||||||0.7688|||||||t-test|||4 months before index date||||0.7688
72393789|NCT03975790|144294245|SUPERIORITY|||||||0.5685|||||||t-test|||5 months before index date||||0.5685
72393790|NCT03975790|144294245|SUPERIORITY|||||||0.5122|||||||t-test|||5 months before index date||||0.5122
72393791|NCT03975790|144294245|SUPERIORITY|||||||0.4321|||||||t-test|||5 months before index date||||0.4321
72393792|NCT03975790|144294245|SUPERIORITY|||||||0.7892|||||||t-test|||6 months before index date||||0.7892
72393793|NCT03975790|144294245|SUPERIORITY|||||||0.2874|||||||t-test|||6 months before index date||||0.2874
72393794|NCT03975790|144294245|SUPERIORITY|||||||0.2662|||||||t-test|||6 months before index date||||0.2662
72393795|NCT03975790|144294245|SUPERIORITY|||||||0.3091|||||||t-test|||7 months before index date||||0.3091
72393796|NCT03975790|144294245|SUPERIORITY|||||||0.5783|||||||t-test|||7 months before index date||||0.5783
72393797|NCT03975790|144294245|SUPERIORITY|||||||0.4021|||||||t-test|||7 months before index date||||0.4021
72393798|NCT03975790|144294245|SUPERIORITY|||||||0.767|||||||t-test|||8 months before index date||||0.7670
72393799|NCT03975790|144294245|SUPERIORITY|||||||0.6978|||||||t-test|||8 months before index date||||0.6978
72393800|NCT03975790|144294245|SUPERIORITY|||||||0.6328|||||||t-test|||8 months before index date||||0.6328
72393801|NCT03975790|144294245|SUPERIORITY|||||||0.0541|||||||t-test|||9 months before index date||||0.0541
72393802|NCT03975790|144294245|SUPERIORITY|||||||0.6999|||||||t-test|||9 months before index date||||0.6999
72393803|NCT03975790|144294245|SUPERIORITY|||||||0.359|||||||t-test|||9 months before index date||||0.3590
72393804|NCT03975790|144294245|SUPERIORITY|||||||0.936|||||||t-test|||10 months before index date||||0.9360
72393805|NCT03975790|144294245|SUPERIORITY|||||||0.626|||||||t-test|||10 months before index date||||0.6260
72393806|NCT03975790|144294245|SUPERIORITY|||||||0.7797|||||||t-test|||10 months before index date||||0.7797
72393807|NCT03975790|144294245|SUPERIORITY|||||||0.0934|||||||t-test|||11 months before index date||||0.0934
72393808|NCT03975790|144294245|SUPERIORITY|||||||0.396|||||||t-test|||11 months before index date||||0.3960
72393809|NCT03975790|144294245|SUPERIORITY|||||||0.4292|||||||t-test|||11 months before index date||||0.4292
72393810|NCT03975790|144294245|SUPERIORITY|||||||0.854|||||||t-test|||12 months before index date||||0.8540
72393811|NCT03975790|144294245|SUPERIORITY|||||||0.96|||||||t-test|||12 months before index date||||0.9600
72393812|NCT03975790|144294245|SUPERIORITY|||||||0.9374|||||||t-test|||12 months before index date||||0.9374
72393813|NCT03975790|144294245|SUPERIORITY|||||||0.6674|||||||t-test|||1 month after index date||||0.6674
72393814|NCT03975790|144294245|SUPERIORITY|||||||0.0776|||||||t-test|||1 month after index date||||0.0776
72393815|NCT03975790|144294245|SUPERIORITY|||||||0.335|||||||t-test|||1 month after index date||||0.3350
72393816|NCT03975790|144294245|SUPERIORITY|||||||0.8461|||||||t-test|||2 month after index date||||0.8461
72393817|NCT03975790|144294245|SUPERIORITY|||||||0.8111|||||||t-test|||2 month after index date||||0.8111
72393818|NCT03975790|144294245|SUPERIORITY|||||||0.7267|||||||t-test|||2 month after index date||||0.7267
72393819|NCT03975790|144294245|SUPERIORITY|||||||0.2453|||||||t-test|||3 month after index date||||0.2453
72393820|NCT03975790|144294245|SUPERIORITY|||||||0.5889|||||||t-test|||3 month after index date||||0.5889
72393821|NCT03975790|144294245|SUPERIORITY|||||||0.4162|||||||t-test|||3 month after index date||||0.4162
72393822|NCT03975790|144294245|SUPERIORITY|||||||0.0307|||||||t-test|||4 month after index date||||0.0307
72393823|NCT03975790|144294245|SUPERIORITY|||||||0.1147|||||||t-test|||4 month after index date||||0.1147
72393824|NCT03975790|144294245|SUPERIORITY|||||||0.9481|||||||t-test|||4 month after index date||||0.9481
72393825|NCT03975790|144294245|SUPERIORITY|||||||0.4455|||||||t-test|||5 month after index date||||0.4455
72393826|NCT03975790|144294245|SUPERIORITY|||||||0.9445|||||||t-test|||5 month after index date||||0.9445
72393827|NCT03975790|144294245|SUPERIORITY|||||||0.6191|||||||t-test|||5 month after index date||||0.6191
72393828|NCT03975790|144294245|SUPERIORITY|||||||0.0805|||||||t-test|||6 month after index date||||0.0805
72463669|NCT03449134|144449971|OTHER||Estimated Percent Change Difference|-17.68||||0.056|TWO_SIDED|95.0|-32.57|0.5||Comparison based on a longitudinal ANCOVA model that included treatment, visit, treatment-by-visit interaction, gender, region, log-transformed baseline value, and log-transformed baseline value-by-visit as covariates.|ANCOVA|||Estimated relative reduction (ERR) relative to Placebo (i.e. estimated percent change difference) was calculated by 100 (e\*\*DIFF -1), where e = exponent of difference; and DIFF= treatment difference in change from baseline at Week 12 based on log transformed data.||0.50|-32.57|0.056
72463670|NCT03449134|144449971|OTHER||Estimated Percent Change Difference|2.95||||0.77|TWO_SIDED|95.0|-15.33|25.19||Comparison based on a longitudinal ANCOVA model that included treatment, visit, treatment-by-visit interaction, gender, region, log-transformed baseline value, and log-transformed baseline value-by-visit as covariates.|ANCOVA|||Estimated relative reduction (ERR) relative to Placebo (i.e. estimated percent change difference) was calculated by 100 (e\*\*DIFF -1), where e = exponent of difference; and DIFF= treatment difference in change from baseline at Week 12 based on log transformed data.||25.19|-15.33|0.770
72463671|NCT03449134|144449972|OTHER||Odds Ratio (OR)|1.2||||0.416|TWO_SIDED|95.0|0.77|1.86|||Regression, Logistic|||Comparison based on a logistic regression model that included treatment, visit, treatment-by-visit interaction, gender, region, baseline, and the interaction of baseline (underlying continuous response) by visit as covariates.||1.86|0.77|0.416
72502116|NCT02799381|144534307|SUPERIORITY|The likelihood-based mixed-effects model repeated measures (MMRM) analysis of the change from baseline to Week 12 used all observed data. The model included fixed, categorical effects for treatment, country, visit, and treatment-by-visit interaction, with continuous fixed covariates for baseline score and the baseline score-by-visit interaction.|LS Mean Difference|-5.54|||=|0.0006|TWO_SIDED|95.0|-8.59|-2.49||Two-sided p-value|Mixed-effects model repeated measures||Levodopa-Carbidopa Intestinal Gel (LCIG) - Optimized Medical Treatment (OMT) at Week 12|If the primary efficacy variable was statistically significant, each of the secondary variables were to be tested using a fixed sequence as a gatekeeping procedure and at α level of 0.050. Testing was to cease at the point that a secondary variable failed to demonstrate statistical significance.||-2.49|-8.59|=0.0006
72502117|NCT02799381|144534308|SUPERIORITY|The likelihood-based mixed-effects model repeated measures (MMRM) analysis of the change from baseline to Week 12 used all observed data. The model included fixed, categorical effects for treatment, country, visit, and treatment-by-visit interaction, with continuous fixed covariates for baseline score and the baseline score-by-visit interaction.|LS Mean Difference|-2.35|||=|0.0002|TWO_SIDED|95.0|-3.51|-1.19||Two-sided p-value|Mixed-effects model repeated measures||Levodopa-Carbidopa Intestinal Gel (LCIG) - Optimized Medical Treatment (OMT) at Week 12|If the primary efficacy variable was statistically significant, each of the secondary variables were to be tested using a fixed sequence as a gatekeeping procedure and at α level of 0.050. Testing was to cease at the point that a secondary variable failed to demonstrate statistical significance.||-1.19|-3.51|=0.0002
72502118|NCT02799381|144534309|SUPERIORITY|The likelihood-based mixed-effects model repeated measures (MMRM) analysis of the change from baseline to Week 12 used all observed data. The model included fixed, categorical effects for treatment, country, visit, and treatment-by-visit interaction, with continuous fixed covariates for baseline score and the baseline score-by-visit interaction.|LS Mean Difference|-4.05|||=|0.0762|TWO_SIDED|95.0|-8.55|0.44||Two-sided p-value|Mixed-effects model repeated measures||Levodopa-Carbidopa Intestinal Gel (LCIG) - Optimized Medical Treatment (OMT) at Week 12|If the primary efficacy variable was statistically significant, each of the secondary variables were to be tested using a fixed sequence as a gatekeeping procedure and at α level of 0.050. Testing was to cease at the point that a secondary variable failed to demonstrate statistical significance.||0.44|-8.55|=0.0762
72502119|NCT04425850|144534310|OTHER||||||<|0.0001|||||||Chi-squared|||Chi-squared test on the percentage of subjects who contracted COVID-19 in each arm||||< 0.0001
72502120|NCT03090191|144534330|SUPERIORITY|Lower bound of confidence interval greater than 20% demonstrate vaccine efficacy.|Vaccine efficacy|31.0|||||TWO_SIDED|96.4|-38.7|66.6|||||Vaccine efficacy(VE)=100\*(1-infection rate ratio\[IRR\]),IRR=calculated ratio of first primary CDI incidence between Clostridium difficile vaccine group and placebo group. 96.4% CI was estimated using Clopper-Pearson-Method.|||66.6|-38.7|
72563842|NCT04025684|144659052|SUPERIORITY||Adjusted Mean Change|-0.1|STANDARD_ERROR_OF_MEAN|0.01|<|0.0001|TWO_SIDED|95.0|-0.11|-0.08||Analysis was performed using ANCOVA Model with product group as a fixed effect and the baseline mean RPI overall value as a covariate.|ANCOVA|||Statistical analysis was performed with comparison in pre-treatment and post-treatment within the treatment group.||-0.08|-0.11|<.0001
72621206|NCT02732145|144773186|EQUIVALENCE|Question: Is there a difference in the incidence of difficulties at starting urination between patients from different groups?||||||0.0015|||||||Chi-squared|||Parameter: The difference in the incidence of difficulties at starting urination between patients from different groups.||||0.0015
72621207|NCT02732145|144773186|EQUIVALENCE|Question: Is there a difference in the incidence of intermittent difficulties at starting urination between patients from different groups?||||||0.0013|||||||Chi-squared|||Parameter: The difference in the incidence of intermittent difficulties at starting urination between patients from different groups.||||0.0013
72393829|NCT03975790|144294245|SUPERIORITY|||||||0.7037|||||||t-test|||6 month after index date||||0.7037
72502121|NCT03090191|144534331|SUPERIORITY|Lower bound of confidence interval greater than 20% demonstrate vaccine efficacy.|Vaccine efficacy|28.6|||||TWO_SIDED|96.4|-28.4|61.0|||||Vaccine efficacy(VE)=100\*(1-infection rate ratio\[IRR\]),IRR=calculated ratio of first primary CDI incidence between Clostridium difficile vaccine group and placebo group. 96.4% CI was estimated using Clopper-Pearson-Method.|||61.0|-28.4|
72502122|NCT03090191|144534340|SUPERIORITY||Vaccine efficacy|11.1|||||TWO_SIDED|98.2|-110.7|62.5|||||VE = 100\*(1 - Hazard Ratio). 98.2% CI was estimated using Proportional Means Model.|||62.5|-110.7|
72502123|NCT03090191|144534341|SUPERIORITY|||||||0.0172|||||||Wilcoxon Rank Sum Test (2-sided)|||||||0.0172
72502124|NCT03090191|144534342|SUPERIORITY||Ratio of proportions|0.0|||||TWO_SIDED|98.2|0.0|0.81||||||||0.81|0.00|
72563843|NCT04025684|144659052|SUPERIORITY||Adjusted Mean Change|-0.12|STANDARD_ERROR_OF_MEAN|0.01|<|0.0001|TWO_SIDED|95.0|-0.14|-0.1||Analysis was performed using ANCOVA model with product group as a fixed effect and the baseline mean RPI overall value as a covariate.|ANCOVA|||Statistical analysis was performed with comparison in pre-treatment and post-treatment within the treatment group.||-0.10|-0.14|<0.0001
72393830|NCT03975790|144294245|SUPERIORITY|||||||0.4288|||||||t-test|||6 month after index date||||0.4288
72393831|NCT03975790|144294245|SUPERIORITY|||||||0.3731|||||||t-test|||7 month after index date||||0.3731
72463672|NCT03449134|144449972|OTHER||Odds Ratio (OR)|1.01||||0.948|TWO_SIDED|95.0|0.66|1.55|||Regression, Logistic|||Comparison based on a logistic regression model that included treatment, visit, treatment-by-visit interaction, gender, region, baseline, and the interaction of baseline (underlying continuous response) by visit as covariates.||1.55|0.66|0.948
72463673|NCT03449134|144449973|OTHER||Odds Ratio (OR)|1.39|||||TWO_SIDED|95.0|0.94|2.05||||||Comparison based on a logistic regression model that included treatment, visit, treatment-by-visit interaction, gender, region, baseline CSD score, and the interaction of baseline (underlying continuous response) by visit as covariates.||2.05|0.94|
72463674|NCT03449134|144449973|OTHER||Odds Ratio (OR)|1.48|||||TWO_SIDED|95.0|1.01|2.18||||||Comparison based on a logistic regression model that included treatment, visit, treatment-by-visit interaction, gender, region, baseline CSD score, and the interaction of baseline (underlying continuous response) by visit as covariates.||2.18|1.01|
72463675|NCT03449134|144449974|OTHER||Odds Ratio (OR)|1.68|||||TWO_SIDED|95.0|1.11|2.54||||||Comparison based on a logistic regression model that included treatment, visit, treatment-by-visit interaction, gender, region, baseline CSD score, and the interaction of baseline (underlying continuous response) by visit as covariates.||2.54|1.11|
72463676|NCT03449134|144449974|OTHER||Odds Ratio (OR)|1.53|||||TWO_SIDED|95.0|1.01|2.3||||||Comparison based on a logistic regression model that included treatment, visit, treatment-by-visit interaction, gender, region, baseline CSD score, and the interaction of baseline (underlying continuous response) by visit as covariates.||2.30|1.01|
72393832|NCT03975790|144294245|SUPERIORITY|||||||0.4803|||||||t-test|||7 month after index date||||0.4803
72393833|NCT03975790|144294245|SUPERIORITY|||||||0.5831|||||||t-test|||7 month after index date||||0.5831
72393834|NCT03975790|144294245|SUPERIORITY|||||||0.0944|||||||t-test|||8 month after index date||||0.0944
72463677|NCT03449134|144449975|OTHER||Odds Ratio (OR)|1.54|||||TWO_SIDED|95.0|1.03|2.3||||||Comparison based on a logistic regression model that included treatment, visit, treatment-by-visit interaction, gender, region, baseline VAS score, and the interaction of baseline (underlying continuous response) by visit as covariates.||2.30|1.03|
72463678|NCT03449134|144449975|OTHER||Odds Ratio (OR)|1.27|||||TWO_SIDED|95.0|0.86|1.89||||||Comparison based on a logistic regression model that included treatment, visit, treatment-by-visit interaction, gender, region, baseline VAS score, and the interaction of baseline (underlying continuous response) by visit as covariates.||1.89|0.86|
72502125|NCT03090191|144534343|SUPERIORITY||Vaccine efficacy|-69.3|||||TWO_SIDED|98.2|-1533.1|75.6|||||Vaccine efficacy(VE)=100\*(1-infection rate ratio\[IRR\]),IRR=calculated ratio of recurrent CDI incidence between Clostridium difficile vaccine group and placebo group. 98.2% CI was estimated using Clopper-Pearson-Method.|||75.6|-1533.1|
72502126|NCT03090191|144534344|SUPERIORITY||Vaccine efficacy|14.9|||||TWO_SIDED|98.2|-74.6|58.5|||||VE = 100\*(1 - Hazard Ratio). 98.2% CI was estimated using Proportional Means Model|||58.5|-74.6|
72502127|NCT03090191|144534345|SUPERIORITY||Vaccine efficacy|-102.4|||||TWO_SIDED|98.2|-1770.1|67.2|||||VE = 100\*(1 - IRR), where IRR= the calculated ratio of recurrent CDI incidence between the Clostridium difficile vaccine group and the placebo group. 98.2% CI was estimated using Clopper-Pearson-Method.|||67.2|-1770.1|
72502128|NCT03090191|144534346|SUPERIORITY||Vaccine efficacy|12.0|||||TWO_SIDED|98.2|-246.7|78.5|||||Vaccine efficacy(VE)=100\*(1-infection rate ratio\[IRR\]),IRR=calculated ratio of first primary CDI incidence between Clostridium difficile vaccine group and placebo group. 98.2% CI was estimated using Clopper-Pearson-Method.|||78.5|-246.7|
72502129|NCT02432807|144534358|SUPERIORITY|||||||0.2219|||||||Chi-squared|||||||0.2219
72502130|NCT02432807|144534359|SUPERIORITY|||||||0.1817|||||||Chi-squared|||||||0.1817
72502131|NCT04419506|144534360|OTHER||Posterior difference|88.4|||||TWO_SIDED|95.0|29.5|154.2|||||Difference calculated as BI 1015550 - Placebo|Adjusted means in the placebo group were combined with the meta-analytic predictive priors derived based on the clinical trials in the nintedanib clinical development program in IPF. In order to evaluate the treatment effects, the posterior distribution for the treatment difference of BI 1015550 versus placebo with respect to the primary endpoint was used. The median of the posterior distribution for the treatment difference (and 95% credible intervals) was calculated.||154.2|29.5|
72502132|NCT04419506|144534360|OTHER||Posterior difference|62.4|||||TWO_SIDED|95.0|6.3|125.5|||||Difference calculated as BI 1015550 - Placebo|Adjusted means in the placebo group were combined with the meta-analytic predictive priors derived based on the clinical trials in the nintedanib clinical development program in IPF. In order to evaluate the treatment effects, the posterior distribution for the treatment difference of BI 1015550 versus placebo with respect to the primary endpoint was used. The median of the posterior distribution for the treatment difference (and 95% credible intervals) was calculated.||125.5|6.3|
72393835|NCT03975790|144294245|SUPERIORITY|||||||0.88|||||||t-test|||8 month after index date||||0.8800
72393836|NCT03975790|144294245|SUPERIORITY|||||||0.4949|||||||t-test|||8 month after index date||||0.4949
72393837|NCT03975790|144294245|SUPERIORITY|||||||0.6373|||||||t-test|||9 month after index date||||0.6373
72393838|NCT03975790|144294245|SUPERIORITY|||||||0.0497|||||||t-test|||9 month after index date||||0.0497
72393839|NCT03975790|144294245|SUPERIORITY|||||||0.1695|||||||t-test|||9 month after index date||||0.1695
72393840|NCT03975790|144294245|SUPERIORITY|||||||0.6373|||||||t-test|||10 month after index date||||0.6373
72393841|NCT03975790|144294245|SUPERIORITY|||||||0.7866|||||||t-test|||10 month after index date||||0.7866
72393842|NCT03975790|144294245|SUPERIORITY|||||||0.7643|||||||t-test|||10 months after index date||||0.7643
72393843|NCT03975790|144294245|SUPERIORITY|||||||0.2307|||||||t-test|||11 month after index date||||0.2307
72463679|NCT03449134|144449976|OTHER||Odds Ratio (OR)|1.3|||||TWO_SIDED|95.0|0.85|1.98||||||Comparison based on a logistic regression model that included visit, treatment-by-visit interaction, gender, region, baseline LCQ score, and the interaction of baseline (underlying continuous response) by visit as covariates.||1.98|0.85|
72463680|NCT03449134|144449976|OTHER||Odds Ratio (OR)|1.39|||||TWO_SIDED|95.0|0.92|2.12||||||Comparison based on a logistic regression model that included visit, treatment-by-visit interaction, gender, region, baseline LCQ score, and the interaction of baseline (underlying continuous response) by visit as covariates.||2.12|0.92|
72463681|NCT00993798|144449977|SUPERIORITY||LS Mean Difference|-1.27|STANDARD_DEVIATION|0.5||0.012|TWO_SIDED|95.0|-2.25|-0.28|||t-test in ANOVA model|||Exploratory comparison between SABER-Bupivacaine and Bupivacaine HCl not analyzed inferentially||-0.28|-2.25|0.012
72393844|NCT03975790|144294245|SUPERIORITY|||||||0.6712|||||||t-test|||11 month after index date||||0.6712
72393845|NCT03975790|144294245|SUPERIORITY|||||||0.6953|||||||t-test|||11 months after index date||||0.6953
72393846|NCT03975790|144294245|SUPERIORITY|||||||0.3675|||||||t-test|||12 month after index date||||0.3675
72393847|NCT03975790|144294245|SUPERIORITY|||||||0.8027|||||||t-test|||12 month after index date||||0.8027
72393848|NCT03975790|144294245|SUPERIORITY|||||||0.4817|||||||t-test|||12 month after index date||||0.4817
72393849|NCT03975790|144294246|SUPERIORITY|||||||0.0063|||||||t-test|||1 month before index date||||0.0063
72393850|NCT03975790|144294246|SUPERIORITY|||||||0.0162|||||||t-test|||1 month before index date||||0.0162
72463682|NCT00993798|144449978|SUPERIORITY||Median Difference (Final Values)|-8.0||||0.01|TWO_SIDED|95.0|-12.0|0.0|||Wilcoxon (Mann-Whitney)|||Exploratory comparison between SABER-Bupivacaine and Bupivacaine HCl not analyzed inferentially||0.0|-12.0|0.010
72463683|NCT00993798|144449979|SUPERIORITY|||||||0.014|||||||Log Rank|||Exploratory comparison between SABER-Bupivacaine and Bupivacaine HCl not analyzed inferentially||||0.014
72393851|NCT03975790|144294246|SUPERIORITY|||||||0.8715|||||||t-test|||1 month before index date||||0.8715
72393852|NCT03975790|144294246|SUPERIORITY|||||||0.2799|||||||t-test|||2 months before index date||||0.2799
72463684|NCT00993798|144449980|SUPERIORITY||Mean Difference (Final Values)|-0.02|STANDARD_DEVIATION|0.08||0.773|TWO_SIDED|95.0|-0.18|0.14|||ANOVA|||Exploratory comparison between SABER-Bupivacaine and Bupivacaine HCl not analyzed inferentially||0.14|-0.18|0.773
72502133|NCT02513940|144534371|SUPERIORITY|||||||0.09|||||||Mixed Models Analysis|||||||0.09
72393853|NCT03975790|144294246|SUPERIORITY|||||||0.0126|||||||t-test|||2 months before index date||||0.0126
72393854|NCT03975790|144294246|SUPERIORITY|||||||0.2126|||||||t-test|||2 months before index date||||0.2126
72393855|NCT03975790|144294246|SUPERIORITY|||||||0.7004|||||||t-test|||3 months before index date||||0.7004
72393856|NCT03975790|144294246|SUPERIORITY|||||||0.1476|||||||t-test|||3 months before index date||||0.1476
72393857|NCT03975790|144294246|SUPERIORITY|||||||0.2057|||||||t-test|||3 months before index date||||0.2057
72393858|NCT03975790|144294246|SUPERIORITY|||||||0.2905|||||||t-test|||4 months before index date||||0.2905
72393859|NCT03975790|144294246|SUPERIORITY|||||||0.8273|||||||t-test|||4 months before index date||||0.8273
72393860|NCT03975790|144294246|SUPERIORITY|||||||0.627|||||||t-test|||4 months before index date||||0.6270
72393861|NCT03975790|144294246|SUPERIORITY|||||||0.3256|||||||t-test|||5 months before index date||||0.3256
72393862|NCT03975790|144294246|SUPERIORITY|||||||0.5631|||||||t-test|||5 months before index date||||0.5631
72393863|NCT03975790|144294246|SUPERIORITY|||||||0.4491|||||||t-test|||5 months before index date||||0.4491
72393864|NCT03975790|144294246|SUPERIORITY|||||||0.2009|||||||t-test|||6 months before index date||||0.2009
72393865|NCT03975790|144294246|SUPERIORITY|||||||0.3011|||||||t-test|||6 months before index date||||0.3011
72393866|NCT03975790|144294246|SUPERIORITY|||||||0.2065|||||||t-test|||6 months before index date||||0.2065
72393867|NCT03975790|144294246|SUPERIORITY|||||||0.6098|||||||t-test|||7 months before index date||||0.6098
72393868|NCT03975790|144294246|SUPERIORITY|||||||0.2586|||||||t-test|||7 months before index date||||0.2586
72393869|NCT03975790|144294246|SUPERIORITY|||||||0.4074|||||||t-test|||7 months before index date||||0.4074
72393870|NCT03975790|144294246|SUPERIORITY|||||||0.0345|||||||t-test|||8 months before index date||||0.0345
72393871|NCT03975790|144294246|SUPERIORITY|||||||0.4377|||||||t-test|||8 months before index date||||0.4377
72393872|NCT03975790|144294246|SUPERIORITY|||||||0.7191|||||||t-test|||8 months before index date||||0.7191
72393873|NCT03975790|144294246|SUPERIORITY|||||||0.0199|||||||t-test|||9 months before index date||||0.0199
72393874|NCT03975790|144294246|SUPERIORITY|||||||0.1032|||||||t-test|||9 months before index date||||0.1032
72393875|NCT03975790|144294246|SUPERIORITY|||||||0.904|||||||t-test|||9 months before index date||||0.9040
72393876|NCT03975790|144294246|SUPERIORITY|||||||0.0316|||||||t-test|||10 months before index date||||0.0316
72393877|NCT03975790|144294246|SUPERIORITY|||||||0.6748|||||||t-test|||10 months before index date||||0.6748
72393878|NCT03975790|144294246|SUPERIORITY|||||||0.2679|||||||t-test|||10 months before index date||||0.2679
72393879|NCT03975790|144294246|SUPERIORITY|||||||0.501|||||||t-test|||11 months before index date||||0.5010
72393880|NCT03975790|144294246|SUPERIORITY|||||||0.3228|||||||t-test|||11 months before index date||||0.3228
72393881|NCT03975790|144294246|SUPERIORITY|||||||0.7881|||||||t-test|||11 months before index date||||0.7881
72393882|NCT03975790|144294246|SUPERIORITY|||||||0.0876|||||||t-test|||12 months before index date||||0.0876
72393883|NCT03975790|144294246|SUPERIORITY|||||||0.1226|||||||t-test|||12 months before index date||||0.1226
72393884|NCT03975790|144294246|SUPERIORITY|||||||0.9753|||||||t-test|||12 months before index date||||0.9753
72393885|NCT03975790|144294246|SUPERIORITY|||||||0.0336|||||||t-test|||1 month after index date||||0.0336
72393886|NCT03975790|144294246|SUPERIORITY|||||||0.2551|||||||t-test|||1 month after index date||||0.2551
72393887|NCT03975790|144294246|SUPERIORITY|||||||0.6189|||||||t-test|||1 month after index date||||0.6189
72393888|NCT03975790|144294246|SUPERIORITY|||||||0.7051|||||||t-test|||2 months after index date||||0.7051
72393889|NCT03975790|144294246|SUPERIORITY|||||||0.9775|||||||t-test|||2 months after index date||||0.9775
72463685|NCT01960348|144450005|SUPERIORITY||Least Squares Mean Difference|-33.99|STANDARD_ERROR_OF_MEAN|2.974|<|1e-07|TWO_SIDED|95.0|-39.86|-28.13||P=9.262E-24|Mixed-effect Model Repeated Measures|||In the mixed-effect model repeated measures (MMRM) model, the outcome variable is change from baseline in mNIS+7. The model includes baseline mNIS+7 score as covariate and fixed effect terms including treatment group, visit, treatment-by-visit interaction, genotype, age at hATTR symptom onset, previous tetramer stabilizer use and region.||-28.13|-39.86|<0.0000001
72502134|NCT02513940|144534372|SUPERIORITY|||||||0.001||||||"Pairwise comparisons:~Testosterone vs placebo: p=0.008 Progesterone vs placebo: p=0.73 Testosterone vs progesterone: p=0.0008"|Mixed Models Analysis|||||||0.001
72502135|NCT02513940|144534373|SUPERIORITY|||||||0.6|||||||Mixed Models Analysis|Repeated measures ANOVA||||||0.60
72502136|NCT02513940|144534374|SUPERIORITY|||||||0.0003||||||"Pairwise comparisons:~Testosterone vs placebo: p = 0.0001 Progesterone vs placebo: p = 0.25 Testosterone vs progesterone: p = 0.002"|Mixed Models Analysis|Repeated measures ANOVA||||||0.0003
72393890|NCT03975790|144294246|SUPERIORITY|||||||0.7643|||||||t-test|||2 months after index date||||0.7643
72393891|NCT03975790|144294246|SUPERIORITY|||||||0.2953|||||||t-test|||3 months after index date||||0.2953
72393892|NCT03975790|144294246|SUPERIORITY|||||||0.6257|||||||t-test|||3 months after index date||||0.6257
72393893|NCT03975790|144294246|SUPERIORITY|||||||0.4753|||||||t-test|||3 months after index date||||0.4753
72463686|NCT01960348|144450006|SUPERIORITY||Least Squares Mean Difference|-21.1|STANDARD_ERROR_OF_MEAN|3.1|<|1e-07|TWO_SIDED|95.0|-27.2|-15.0||P=1.103E-10|Mixed-effect Model Repeated Measures|||In the mixed-effect model repeated measures (MMRM) model, the outcome variable is change from baseline in Norfolk QOL-DN total score. The model includes baseline Norfolk QOL-DN score as covariate and fixed effect terms including treatment group, visit, treatment-by-visit interaction, baseline NIS, genotype, age at hATTR symptom onset, previous tetramer stabilizer use and region.||-15.0|-27.2|<0.0000001
72463687|NCT01960348|144450007|SUPERIORITY||Least Squares Mean Difference|-17.87|STANDARD_ERROR_OF_MEAN|2.254|<|1e-07|TWO_SIDED|95.0|-22.32|-13.43||P=1.404E-13|Mixed-effect Model Repeated Measures|||In the mixed-effect model repeated measures (MMRM) model, the outcome variable is change from baseline in NIS-W. The model includes baseline NIS-W score as covariate and fixed effect terms including treatment group, visit, treatment-by-visit interaction, genotype, age at hATTR symptom onset, previous tetramer stabilizer use and region.||-13.43|-22.32|<0.0000001
72621208|NCT02732145|144773186|EQUIVALENCE|Question: Is there a difference in the incidence of frequent difficulties at starting urination between patients from different groups?||||||0.5673|||||||Chi-squared|||Parameter: The difference in the incidence of frequent difficulties at starting urination between patients from different groups.||||0.5673
72393894|NCT03975790|144294246|SUPERIORITY|||||||0.0926|||||||t-test|||4 months after index date||||0.0926
72393895|NCT03975790|144294246|SUPERIORITY|||||||0.0013|||||||t-test|||4 months after index date||||0.0013
72463688|NCT01960348|144450008|SUPERIORITY||Least Squares Mean Difference|9.0|STANDARD_ERROR_OF_MEAN|1.01|<|1e-07|TWO_SIDED|95.0|7.0|10.9||P=4.066E-16|Mixed-effect Model Repeated Measures|||In the mixed-effect model repeated measures (MMRM) model, the outcome variable is change from baseline in R-ODS value. The model includes baseline R-ODS score as covariate and fixed effect terms including treatment group, visit, treatment-by-visit interaction, baseline NIS, genotype, age at hATTR symptom onset, previous tetramer stabilizer use and region.||10.9|7.0|<0.0000001
72393896|NCT03975790|144294246|SUPERIORITY|||||||0.0065|||||||t-test|||4 months after index date||||0.0065
72393897|NCT03975790|144294246|SUPERIORITY|||||||0.2212|||||||t-test|||5 months after index date||||0.2212
72393898|NCT03975790|144294246|SUPERIORITY|||||||0.9688|||||||t-test|||5 months after index date||||0.9688
72393899|NCT03975790|144294246|SUPERIORITY|||||||0.5647|||||||t-test|||5 months after index date||||0.5647
72393900|NCT03975790|144294246|SUPERIORITY|||||||0.0023|||||||t-test|||6 months after index date||||0.0023
72393901|NCT03975790|144294246|SUPERIORITY|||||||0.1142|||||||t-test|||6 months after index date||||0.1142
72393902|NCT03975790|144294246|SUPERIORITY|||||||0.3842|||||||t-test|||6 months after index date||||0.3842
72393903|NCT03975790|144294246|SUPERIORITY|||||||0.9097|||||||t-test|||7 months after index date||||0.9097
72393904|NCT03975790|144294246|SUPERIORITY|||||||0.3885|||||||t-test|||7 months after index date||||0.3885
72393905|NCT03975790|144294246|SUPERIORITY|||||||0.3834|||||||t-test|||7 months after index date||||0.3834
72393906|NCT03975790|144294246|SUPERIORITY|||||||0.3075|||||||t-test|||8 months after index date||||0.3075
72393907|NCT03975790|144294246|SUPERIORITY|||||||0.9075|||||||t-test|||8 months after index date||||0.9075
72393908|NCT03975790|144294246|SUPERIORITY|||||||0.5993|||||||t-test|||8 months after index date||||0.5993
72393909|NCT03975790|144294246|SUPERIORITY|||||||0.0775|||||||t-test|||9 months after index date||||0.0775
72393910|NCT03975790|144294246|SUPERIORITY|||||||0.1536|||||||t-test|||9 months after index date||||0.1536
72393911|NCT03975790|144294246|SUPERIORITY|||||||0.8553|||||||t-test|||9 months after index date||||0.8553
72393912|NCT03975790|144294246|SUPERIORITY|||||||0.6295|||||||t-test|||10 months after index date||||0.6295
72393913|NCT03975790|144294246|SUPERIORITY|||||||0.0551|||||||t-test|||10 months after index date||||0.0551
72393914|NCT03975790|144294246|SUPERIORITY|||||||0.2215|||||||t-test|||10 months after index date||||0.2215
72393915|NCT03975790|144294246|SUPERIORITY|||||||0.1948|||||||t-test|||11 months after index date||||0.1948
72393916|NCT03975790|144294246|SUPERIORITY|||||||0.6621|||||||t-test|||11 months after index date||||0.6621
72393917|NCT03975790|144294246|SUPERIORITY|||||||0.6629|||||||t-test|||11 months after index date||||0.6629
72393918|NCT03975790|144294246|SUPERIORITY|||||||0.5699|||||||t-test|||12 months after index date||||0.5699
72393919|NCT03975790|144294246|SUPERIORITY|||||||0.7105|||||||t-test|||12 months after index date||||0.7105
72393920|NCT03975790|144294246|SUPERIORITY|||||||0.5965|||||||t-test|||12 months after index date||||0.5965
72502137|NCT02513940|144534375|SUPERIORITY||||||>|0.99|||||||Fisher Exact|||Fatigue||||>0.99
72502138|NCT02513940|144534375|SUPERIORITY||||||>|0.99|||||||Fisher Exact|||Rash at gel application site||||>0.99
72502139|NCT02966314|144534406|SUPERIORITY||Odds Ratio (OR)|18.7||||0.003|TWO_SIDED|95.0|2.77|126.47|||Regression, Logistic|Accounting for repeated measures||||126.47|2.77|0.003
72502140|NCT02966314|144534408|SUPERIORITY||Mean Difference (Final Values)|9.43||||0.03|TWO_SIDED|95.0|1.24|17.63|||Regression, Linear|||||17.63|1.24|0.03
72502141|NCT02966314|144534410|SUPERIORITY||Odds Ratio (OR)|32.8||||0.03|TWO_SIDED|95.0|1.49|720.54|||Regression, Logistic|Accounting for repeated measures||||720.54|1.49|0.03
72502142|NCT02966314|144534412|SUPERIORITY||Risk Ratio (RR)|6.9||||0.005|TWO_SIDED|95.0|1.9|25.3|||Regression, Linear|Accounting for multiple measures, using poisson distribution with natural log link||||25.3|1.9|0.005
72502143|NCT01075087|144534437|SUPERIORITY_OR_OTHER||Median Difference (Net)|-5.5||||0.05|TWO_SIDED|90.0|-26.0|3.0|||Wilcoxon (Mann-Whitney)|||||3|-26|.05
72502144|NCT00811252|144534441|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.32|STANDARD_ERROR_OF_MEAN|1.01||0.0011|TWO_SIDED|95.0|-5.31|-1.34||Since p-value \<0.05, hierarchically testing continued|ANCOVA||A statistical testing strategy was defined a priori for a single dose of vortioxetine that was tested versus placebo in the primary and key secondary efficacy analyses.|As soon as an endpoint was non-significant at the 0.05 level of significance, the testing procedure was stopped for all subsequent endpoints.||-1.34|-5.31|0.0011
72463689|NCT01960348|144450009|SUPERIORITY||Least Squares Mean Difference|0.311|STANDARD_ERROR_OF_MEAN|0.0415|<|1e-07|TWO_SIDED|95.0|0.23|0.393||P=1.875E-12|Mixed-effect Model Repeated Measures|||In the mixed-effect model repeated measures (MMRM) model, the outcome variable is change from baseline in 10-meter walk test result. The model includes baseline 10-meter walk test result as covariate and fixed effect terms including treatment group, visit, treatment-by-visit interaction, baseline NIS, genotype, age at hATTR symptom onset, previous tetramer stabilizer use and region.||0.393|0.230|<0.0000001
72463690|NCT01960348|144450010|SUPERIORITY||Least Squares Mean Difference|115.7|STANDARD_ERROR_OF_MEAN|16.91|<|1e-07|TWO_SIDED|95.0|82.4|149.0||P=8.832E-11|Mixed-effect Model Repeated Measures|||In the mixed-effect model repeated measures (MMRM) model, the outcome variable is change from baseline in mBMI. The model includes baseline mBMI as covariate and fixed effect terms including treatment group, visit, treatment-by-visit interaction, baseline NIS, genotype, age at hATTR symptom onset, previous tetramer stabilizer use and region.||149.0|82.4|<0.0000001
72463691|NCT01960348|144450011|SUPERIORITY||Least Squares Mean Difference|-7.53|STANDARD_ERROR_OF_MEAN|2.213||0.0008|TWO_SIDED|95.0|-11.89|-3.16|||Mixed-effect Model Repeated Measures|||In the mixed-effect model repeated measures (MMRM) model, the outcome variable is change from baseline in COMPASS-31 total score. The model includes baseline COMPASS-31 score as covariate and fixed effect terms including treatment group, visit, treatment-by-visit interaction, baseline NIS, genotype, age at hATTR symptom onset, previous tetramer stabilizer use and region.||-3.16|-11.89|0.0008
72463692|NCT01580995|144450012|SUPERIORITY_OR_OTHER|||||||0.05|||||||Fisher Exact|||||||0.05
72463693|NCT00275301|144450015|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0|||||Regression, Linear|||Examination of relationship between Borderline Personality Disorder symptoms and brain metabolism at baseline.||||<0.05
72463694|NCT02097849|144450016|SUPERIORITY_OR_OTHER||Difference in proportion|-0.04||||0.692|TWO_SIDED|95.0|-0.27|0.19|||Clopper-Pearson Exact|||||0.19|-0.27|0.692
72463695|NCT02097849|144450017|SUPERIORITY_OR_OTHER||Difference in proportion|-0.19||||0.12|TWO_SIDED|95.0|-0.41|0.05|||Clopper-Pearson Exact|||Responders at Day 28||0.05|-0.41|0.120
72463696|NCT02097849|144450018|SUPERIORITY_OR_OTHER||Difference in proportions|-0.13||||0.225|TWO_SIDED|95.0|-0.35|0.1|||Clopper-Pearson Exact|||||0.10|-0.35|0.225
72463697|NCT02097849|144450019|SUPERIORITY_OR_OTHER||Difference in proportions|-0.22||||0.057|TWO_SIDED|95.0|-0.44|0.01|||Clopper-Pearson Exact|||||0.01|-0.44|0.057
72463698|NCT02097849|144450020|SUPERIORITY_OR_OTHER||Difference in proportions|0.07||||0.3|TWO_SIDED|95.0|-0.16|0.3|||Clopper-Pearson Exact|||||0.30|-0.16|0.300
72463699|NCT02097849|144450021|SUPERIORITY_OR_OTHER||Difference in proportions|-0.03||||0.714|TWO_SIDED|95.0|-0.26|0.2|||Clopper-Pearson Exact|||||0.20|-0.26|0.714
72463700|NCT02097849|144450022|SUPERIORITY_OR_OTHER||Difference in proportions|0.0||||0.967|TWO_SIDED|95.0|-0.24|0.23|||Clopper-Pearson Exact|||||0.23|-0.24|0.967
72463701|NCT02097849|144450023|SUPERIORITY_OR_OTHER||Difference in proportions|-0.01||||0.955|TWO_SIDED|95.0|-0.24|0.22|||Clopper-Pearson Exact|||||0.22|-0.24|0.955
72463702|NCT01540162|144450032|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.23||||0.05|TWO_SIDED|95.0|0.05|0.73|||Chi-squared|||||0.73|0.05|0.05
72463703|NCT02561078|144450038|NON_INFERIORITY|The test for the primary objective of noninferiority was performed at the 0.05 significance level using the LS Mean estimate of the difference in change in HbA1c between the 2 treatments at Week 26. Noninferiority was established if the upper limit of a 2-sided 95% confidence interval (CI) for the difference (U 500R CSII minus U 500R MDI) was below the noninferiority margin (NIM) of 0.4%.|Mean Difference (Net)|-0.42|||<|0.001|TWO_SIDED|95.0|-0.62|-0.22|||Mixed Models Analysis|||||-0.22|-0.62|<0.001
72463704|NCT02561078|144450039|SUPERIORITY||Mean Difference (Net)|-35.6|||<|0.001|TWO_SIDED|95.0|-49.4|-21.7|||Mixed Models Analysis|||||-21.7|-49.4|<0.001
72463705|NCT02561078|144450040|SUPERIORITY||Odds Ratio (OR)|1.97||||0.015|TWO_SIDED|95.0|1.14|3.39|||Regression, Logistic|||||3.39|1.14|0.015
72463706|NCT02561078|144450041|SUPERIORITY||Odds Ratio (OR)|1.94||||0.005|TWO_SIDED|95.0|1.23|3.07|||Regression, Logistic|||||3.07|1.23|0.005
72463707|NCT02561078|144450042|SUPERIORITY||Mean Difference (Net)|-22.5|||<|0.001|TWO_SIDED|95.0|-32.1|-12.8|||Mixed Models Analysis|||Pre Morning Meal||-12.8|-32.1|<0.001
72463708|NCT02561078|144450042|SUPERIORITY||Mean Difference (Net)|-17.2||||0.008|TWO_SIDED|95.0|-29.9|-4.6|||Mixed Models Analysis|||2 Hours Post Morning Meal||-4.6|-29.9|0.008
72463709|NCT02561078|144450042|SUPERIORITY||Mean Difference (Net)|-8.9||||0.138|TWO_SIDED|95.0|-20.6|2.9|||Mixed Models Analysis|||Pre Mid-Day Meal||2.9|-20.6|0.138
72463710|NCT02561078|144450042|SUPERIORITY||Mean Difference (Net)|8.3||||0.16|TWO_SIDED|95.0|-3.3|19.8|||Mixed Models Analysis|||2 Hours Post Mid-Day Meal||19.8|-3.3|0.160
72463711|NCT02561078|144450042|SUPERIORITY||Mean Difference (Net)|9.1||||0.113|TWO_SIDED|95.0|-2.2|20.4|||Mixed Models Analysis|||Pre Evening Meal||20.4|-2.2|0.113
72463712|NCT02561078|144450042|SUPERIORITY||Mean Difference (Net)|16.7||||0.004|TWO_SIDED|95.0|5.3|28.2|||Mixed Models Analysis|||2 Hours Post Evening Meal||28.2|5.3|0.004
72463713|NCT02561078|144450042|SUPERIORITY||Mean Difference (Net)|0.6||||0.905|TWO_SIDED|95.0|-9.5|10.8|||Mixed Models Analysis|||Overnight (3:00 AM)||10.8|-9.5|0.905
72463714|NCT02561078|144450043|SUPERIORITY||Mean Difference (Net)|-48.4|||<|0.001|TWO_SIDED|95.0|-74.1|-22.8|||Mixed Models Analysis|||||-22.8|-74.1|<0.001
72463715|NCT02561078|144450044|SUPERIORITY||Odds Ratio (OR)|1.05||||0.919|TWO_SIDED|95.0|0.39|2.86|||Regression, Logistic|||||2.86|0.39|0.919
72463716|NCT02561078|144450045|SUPERIORITY||Relative Rate|1.21||||0.025|TWO_SIDED|95.0|1.02|1.42|||Negative binomial regression|||||1.42|1.02|0.025
72463717|NCT02561078|144450046|SUPERIORITY||Mean Difference (Net)|0.8||||0.1|TWO_SIDED|95.0|-0.2|1.8|||Mixed Models Analysis|||||1.8|-0.2|0.100
72463718|NCT00821119|144450095|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.7|STANDARD_ERROR_OF_MEAN|0.16|<|0.05|TWO_SIDED|95.0|0.48|1.14|||risk ratio (RR)|||"Based on previous data from our NICU, 40 - 45% of our preterm infants administered early NCPAP for RDS needed intubation and mechanical ventilation within the first 72h of life. We estimated a 20% absolute reduction in the need of using ETT ventilation with the early use of NIPPV. A sample size of 100 infants per group was calculated with a power of 80% and an alpha error of 5%.~The analysis was performed according to the intention-to-treat principle."||1.14|0.48|<0.05
72502145|NCT00811252|144534441|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.48|STANDARD_ERROR_OF_MEAN|1.03|<|0.0001|TWO_SIDED|95.0|-7.5|-3.46||This treatment arm was not in the testing sequence. A nominal p-value is provided.|ANCOVA|||||-3.46|-7.50|<0.0001
72463719|NCT00821119|144450096|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.7|STANDARD_ERROR_OF_MEAN|0.16||0.05|TWO_SIDED|95.0|0.48|1.14|||risk ratio (RR)|||Based on previous data from our NICU, 40 - 45% of our preterm infants administered early NCPAP for RDS needed intubation and mechanical ventilation within the first 72h of life. We estimated a 20% absolute reduction in the need of using ETT ventilation with the early use of NIPPV. A sample size of 100 infants per group was calculated with a power of 80% and an alpha error of 5%.||1.14|0.48|0.05
72463720|NCT00821119|144450097|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.06|STANDARD_ERROR_OF_MEAN|0.18|<|0.05|TWO_SIDED|95.0|0.62|1.78|||risk ratio (RR)|||The study was not powered for this outcome. However this analysis was done with this limitation||1.78|0.62|< 0.05
72463721|NCT01490359|144450098|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.32||||0.008|TWO_SIDED|95.0|1.03|1.71||The GEE model included baseline measure of consistent condom use, intervention condition, time (6- vs. 12-mo follow-up), and type of partner (steady vs casual partners) with robust standard errors and an independent working correlation matrix.|generalized estimating equations (GEE)||Estimate is odds ratio (intervention vs. health control).|Assuming alpha = 0.05, a 2-tailed test, ICC = 0.01, 15% attrition at 12-month follow-up, and N = 1,152 men in the trial from 44 neighborhoods with an average of 26 men in each neighborhood, the trial was estimated to have 81% power to detect a 10% increase in consistent condom use from 32% to 42% in the HIV/STI intervention group.||1.71|1.03|.008
72463722|NCT05109117|144450125|SUPERIORITY||Adjusted Mean Difference|2.8|||<|0.0001|TWO_SIDED|95.0|1.7|3.9|||ANCOVA|Analysis of Covariance (ANCOVA) model with treatment, timepoint, treatment\*timepoint (interaction) and subject as terms; Baseline value as covariate.||Pairwise comparison between Treated and Untreated sites 2 hours post-treatment||3.9|1.7|<0.0001
72463723|NCT05109117|144450125|SUPERIORITY||Adjusted Mean Difference|1.5||||0.0077|TWO_SIDED|95.0|0.4|2.7|||ANCOVA|ANCOVA model with treatment, timepoint, treatment\*timepoint (interaction) and subject as terms; Baseline value as covariate.||Pairwise comparison between Treated and Untreated sites 4 hours post-treatment||2.7|0.4|0.0077
72463724|NCT05109117|144450125|SUPERIORITY||Adjusted Mean Difference|1.8||||0.0019|TWO_SIDED|95.0|0.7|2.9|||ANCOVA|ANCOVA model with treatment, timepoint, treatment\*timepoint (interaction) and subject as terms; Baseline value as covariate.||Pairwise comparison between Treated and Untreated sites 6 hours post-treatment||2.9|0.7|0.0019
72463725|NCT05109117|144450125|SUPERIORITY||Adjusted Mean Difference|1.0||||0.0707|TWO_SIDED|95.0|-0.1|2.2|||ANCOVA|ANCOVA model with treatment, timepoint, treatment\*timepoint (interaction) and subject as terms; Baseline value as covariate.||Pairwise comparison between Treated and Untreated sites 8 hours post-treatment||2.2|-0.1|0.0707
72463726|NCT02253147|144450186|NON_INFERIORITY|"A WSRS change of 1 grade is considered to be clinically significant. A difference of ≤0.5 grade between the two treatment groups (i.e., half of the clinically significant difference) = non-inferiority margin.~The primary efficacy endpoint uses a paired-design and is analyzed by calculating two-sided confidence intervals of the mean difference between TEOSYAL® RHA UD and the control device, between the V1 enrollment visit (baseline) and V7 (24 weeks after baseline)."|Mean Difference (Final Values)|-0.22|||||TWO_SIDED|95.0|-0.34|-0.11|||||The decision is based on the upper limit of the 2-sided confidence interval for the difference for the change from baseline, between test and comparator treatment. For achieving non-inferiority, the upper confidence limit of a 95.0% CI must be ≤0.5|"Efficacy of TEOSYAL® RHA Ultra Deep versus control is analyzed in a non-inferiority statistical model using the 5-grade Wrinkle Severity Rating Scale (WSRS) as rated by the Blinded Live Evaluator at 24 weeks after baseline.~The primary endpoint is the aesthetic improvement from pre-injection of the NLF at the side of the face treated with TEOSYAL® RHA Ultra Deep compared to the one at the side of the face treated with the control device, as assessed by the BLE at 24 weeks after baseline."||-0.11|-0.34|
72463727|NCT02959177|144450212|SUPERIORITY||LSMean Difference|-3.01|||<|0.001|TWO_SIDED|95.0|-3.8|-2.22|||Mixed Models Analysis|||||-2.22|-3.80|<0.001
72502146|NCT00811252|144534442|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.13|STANDARD_ERROR_OF_MEAN|0.94||0.024|TWO_SIDED|95.0|-3.98|-0.28||Since p-value \<0.05, hierarchically testing continued|ANCOVA||A statistical testing strategy was defined a priori for a single dose of vortioxetine that was tested versus placebo in the primary and key secondary efficacy analyses.|As soon as an endpoint was non-significant at the 0.05 level of significance, the testing procedure was stopped for all subsequent endpoints.||-0.28|-3.98|0.0240
72502147|NCT00811252|144534442|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.22|STANDARD_ERROR_OF_MEAN|0.96|<|0.0001|TWO_SIDED|95.0|-6.1|-2.34||This treatment arm was not in the testing sequence. A nominal p-value is provided.|ANCOVA|||||-2.34|-6.10|<0.0001
72621209|NCT02732145|144773186|EQUIVALENCE|Question: Is there a difference in the incidence of urgency between patients from different groups?||||||0.0065|||||||Chi-squared|||Parameter: The difference in the incidence of urgency between patients from different groups.||||0.0065
72621210|NCT02732145|144773186|EQUIVALENCE|Question: Is there a difference in the incidence of intermittent urgency between patients from different groups?||||||0.083|||||||Chi-squared|||Parameter: The difference in the incidence of intermittent urgency between patients from different groups.||||0.0830
72463728|NCT02959177|144450212|SUPERIORITY||Mean Difference (Final Values)|-2.7|||<|0.001|TWO_SIDED|95.0|-3.53|-1.94|||Mixed Models Analysis|||||-1.94|-3.53|<0.001
72463729|NCT02959177|144450213|SUPERIORITY||Odds Ratio (OR)|3.89|||||TWO_SIDED|95.0|2.71|5.57||||||||5.57|2.71|
72463730|NCT02959177|144450213|SUPERIORITY||Odds Ratio (OR)|3.664|||||TWO_SIDED|95.0|2.54|5.23||||||||5.23|2.54|
72463731|NCT02959177|144450214|SUPERIORITY||Odds Ratio (OR)|3.24|||||TWO_SIDED|95.0|2.14|4.89||||||||4.89|2.14|
72463732|NCT02959177|144450214|SUPERIORITY||Odds Ratio (OR)|3.16|||||TWO_SIDED|95.0|2.08|4.8||||||||4.80|2.08|
72502148|NCT00811252|144534443|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.06|STANDARD_ERROR_OF_MEAN|0.85||0.2134|TWO_SIDED|95.0|-2.72|0.61||Since p-value \>0.05, hierarchically testing stopped here.|ANCOVA|||||0.61|-2.72|0.2134
72502149|NCT00811252|144534443|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.3|STANDARD_ERROR_OF_MEAN|0.86||0.0002|TWO_SIDED|95.0|-4.99|-1.6||This treatment arm was not in the testing sequence. A nominal p-value is provided.|ANCOVA|||||-1.60|-4.99|0.0002
72621211|NCT02732145|144773186|EQUIVALENCE|Question: Is there a difference in the incidence of frequent urgency between patients from different groups?||||||0.0001|||||||Chi-squared|||Parameter: The difference in the incidence of frequent urgency between patients from different groups.||||0.0001
72502150|NCT00811252|144534444|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.28|STANDARD_ERROR_OF_MEAN|0.7||0.6879|TWO_SIDED|95.0|-1.67|1.1||A nominal p-value is provided.|ANCOVA|||||1.10|-1.67|0.6879
72502151|NCT00811252|144534444|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.25|STANDARD_ERROR_OF_MEAN|0.72||0.0827|TWO_SIDED|95.0|-2.65|0.16||A nominal p-value is provided.|ANCOVA|||||0.16|-2.65|0.0827
72502152|NCT00811252|144534445|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.42|STANDARD_ERROR_OF_MEAN|0.55||0.4482|TWO_SIDED|95.0|-1.49|0.66||A nominal p-value is provided.|ANCOVA|||||0.66|-1.49|0.4482
72502153|NCT00811252|144534445|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.14|STANDARD_ERROR_OF_MEAN|0.56||0.7971|TWO_SIDED|95.0|-0.95|1.24||A nominal p-value is provided.|ANCOVA|||||1.24|-0.95|0.7971
72621212|NCT02732145|144773186|EQUIVALENCE|Question: Is there a difference in the incidence of nocturia between patients from different groups?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of nocturia between patients from different groups.||||0.0000
72621213|NCT02732145|144773186|EQUIVALENCE|Question: Is there a difference in the incidence of intermittent nocturia between patients from different groups?||||||0.2315|||||||Chi-squared|||Parameter: The difference in the incidence of intermittent nocturia between patients from different groups.||||0.2315
72621214|NCT02732145|144773186|EQUIVALENCE|Question: Is there a difference in the incidence of frequent nocturia between patients from different groups?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of frequent nocturia between patients from different groups.||||0.0000
72621215|NCT02732145|144773186|EQUIVALENCE|Question: Is there a difference in the incidence of recurrent cystitis between patients from different groups?||||||0.0539|||||||Chi-squared|||Parameter: The difference in the incidence of recurrent cystitis between patients from different groups.||||0.0539
72463733|NCT02959177|144450215|SUPERIORITY||Odds Ratio (OR)|3.47|||||TWO_SIDED|95.0|2.03|5.93||||||||5.93|2.03|
72463734|NCT02959177|144450215|SUPERIORITY||Odds Ratio (OR)|3.13|||||TWO_SIDED|95.0|1.79|5.44||||||||5.44|1.79|
72463735|NCT02959177|144450216|SUPERIORITY||LSMean difference|7.0|||<|0.001|TWO_SIDED|95.0|4.54|9.46|||Mixed Models Analysis|||||9.46|4.54|<0.001
72463736|NCT02959177|144450216|SUPERIORITY||Mean Difference (Final Values)|5.79|||<|0.01|TWO_SIDED|95.0|3.33|8.24|||Mixed Models Analysis|||||8.24|3.33|<0.01
72463737|NCT02959177|144450217|SUPERIORITY||LSMean difference|-2.9|||<|0.001|TWO_SIDED|95.0|-3.61|-2.19|||Mixed Models Analysis|||||-2.19|-3.61|<0.001
72463738|NCT02959177|144450217|SUPERIORITY||LSMean difference|-2.7|||<|0.001|TWO_SIDED|95.0|-3.41|-1.99|||Mixed Models Analysis|||||-1.99|-3.41|<0.001
72463739|NCT02959177|144450219|SUPERIORITY||LSMean Difference|-11.82|||<|0.001|TWO_SIDED|95.0|-16.14|-7.51|||Mixed Models Analysis|||||-7.51|-16.14|<0.001
72463740|NCT02959177|144450219|SUPERIORITY||LSMean difference|-13.73|||<|0.001|TWO_SIDED|95.0|-18.05|-9.4|||Mixed Models Analysis|||||-9.40|-18.05|<0.001
72463741|NCT02959177|144450220|SUPERIORITY||LSMean Difference|-4.9|||<|0.001|TWO_SIDED|95.0|-8.06|-1.73|||Mixed Models Analysis|||||-1.73|-8.06|<0.001
72463742|NCT02959177|144450220|SUPERIORITY||LSMean Difference|-2.97|||<|0.001|TWO_SIDED|95.0|-6.08|0.14|||Mixed Models Analysis|||||0.14|-6.08|<.001
72463743|NCT01947153|144450230|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence test|Geometric mean ratio|102.92|STANDARD_ERROR_OF_MEAN|1.027|<|0.0001|TWO_SIDED|90.0|98.37|107.688||The p-value relates to the null hypothesis of non-equivalence.|ANOVA||The geometric mean ratio is calculated as the geometric mean of 'Fixed dose combination' divided by the geometric mean of 'Free combination '.|||107.688|98.370|<0.0001
72463744|NCT01947153|144450231|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence test|Geometric mean ratio|105.14|STANDARD_ERROR_OF_MEAN|1.032|<|0.0001|TWO_SIDED|90.0|99.645|110.941||The p-value relates to the null hypothesis of non-equivalence.|ANOVA||The geometric mean ratio is calculated as the geometric mean of 'Fixed dose combination' divided by the geometric mean of 'Free combination '.|||110.941|99.645|<0.0001
72463745|NCT01947153|144450232|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence test|Geometric mean ratio|109.05|STANDARD_ERROR_OF_MEAN|1.063||0.0014|TWO_SIDED|90.0|98.299|120.968||The p-value relates to the null hypothesis of non-equivalence.|ANOVA||The geometric mean ratio is calculated as the geometric mean of 'Fixed dose combination' divided by the geometric mean of 'Free combination '.|||120.968|98.299|0.0014
72463746|NCT01947153|144450233|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence test|Geometric mean ratio|105.81|STANDARD_ERROR_OF_MEAN|1.043|<|0.0001|TWO_SIDED|90.0|98.471|113.692||The p-value relates to the null hypothesis of non-equivalence.|ANOVA||The geometric mean ratio is calculated as the geometric mean of 'Fixed dose combination' divided by the geometric mean of 'Free combination '.|||113.692|98.471|<0.0001
72463747|NCT01947153|144450234|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence test|Geometric mean ratio|98.48|STANDARD_ERROR_OF_MEAN|1.04|<|0.0001|TWO_SIDED|90.0|92.177|105.208||The p-value relates to the null hypothesis of non-equivalence.|ANOVA||The geometric mean ratio is calculated as the geometric mean of 'Fixed dose combination' divided by the geometric mean of 'Free combination '.|||105.208|92.177|<0.0001
72463748|NCT01947153|144450235|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence test|Geometric mean ratio|104.62|STANDARD_ERROR_OF_MEAN|1.031|<|0.0001|TWO_SIDED|90.0|99.274|110.254||The p-value relates to the null hypothesis of non-equivalence.|ANOVA||The geometric mean ratio is calculated as the geometric mean of 'Fixed dose combination' divided by the geometric mean of 'Free combination '.|||110.254|99.274|<0.0001
72463749|NCT01947153|144450236|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence test|Geometric mean ratio|102.92|STANDARD_ERROR_OF_MEAN|1.027|<|0.0001|TWO_SIDED|90.0|98.37|107.688||The p-value relates to the null hypothesis of non-equivalence.|ANOVA||The geometric mean ratio is calculated as the geometric mean of 'Fixed dose combination' divided by the geometric mean of 'Free combination '.|||107.688|98.370|<0.0001
72463750|NCT03303521|144450244|SUPERIORITY||Odds Ratio (OR)|68.77|||<|0.001|TWO_SIDED|95.0|10.85|2810.85|||Fisher Exact|||||2810.85|10.85|<0.001
72463751|NCT03303521|144450246|SUPERIORITY||Odds Ratio (OR)|35.51|||<|0.001|TWO_SIDED|95.0|8.53|309.48|||Fisher Exact|||||309.48|8.53|<0.001
72463752|NCT02642159|144450257|SUPERIORITY||LS Mean Difference|-32.5|||<|0.0001|TWO_SIDED|97.5|-38.1|-27.0||Threshold for significance \<=0.025.|Mixed Models Analysis||Alirocumab vs. usual care|Alirocumab group was compared to usual care group using an appropriate contrast statement.||-27.0|-38.1|<0.0001
72393921|NCT01059825|144294275|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.45||||0.002|TWO_SIDED|80.0|-0.65|-0.25||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||The null hypothesis is that there is no difference between ertugliflozin and placebo on the primary endpoint.||-0.25|-0.65|0.002
72393922|NCT01059825|144294275|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.69||||0|TWO_SIDED|80.0|-0.89|-0.49||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p \<0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||The null hypothesis is that there is no difference between ertugliflozin and placebo on the primary endpoint.||-0.49|-0.89|0.000
72393923|NCT01059825|144294275|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.62||||0|TWO_SIDED|80.0|-0.82|-0.42||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p \<0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||The null hypothesis is that there is no difference between ertugliflozin and placebo on the primary endpoint.||-0.42|-0.82|0.000
72393924|NCT01059825|144294275|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.72||||0|TWO_SIDED|80.0|-0.93|-0.52||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p \<0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||The null hypothesis is that there is no difference between ertugliflozin and placebo on the primary endpoint.||-0.52|-0.93|0.000
72393925|NCT01059825|144294275|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.76||||0|TWO_SIDED|80.0|-0.97|-0.56||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p \<0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-0.56|-0.97|0.000
72393926|NCT01059825|144294276|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.13||||0.049|TWO_SIDED|80.0|-0.24|-0.03||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-0.03|-0.24|0.049
72393927|NCT01059825|144294276|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.29||||0|TWO_SIDED|80.0|-0.39|-0.18||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p \<0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-0.18|-0.39|0.000
72393928|NCT01059825|144294276|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.22||||0.004|TWO_SIDED|80.0|-0.32|-0.11||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-0.11|-0.32|0.004
72393929|NCT01059825|144294276|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.17||||0.02|TWO_SIDED|80.0|-0.27|-0.06||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-0.06|-0.27|0.020
72393930|NCT01059825|144294276|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.25||||0.001|TWO_SIDED|80.0|-0.36|-0.15||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-0.15|-0.36|0.001
72502154|NCT00811252|144534446|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.29|STANDARD_ERROR_OF_MEAN|1.03|<|0.0001|TWO_SIDED|95.0|-6.32|-2.26||A nominal p-value is provided. No correction for multiplicity was made.|ANCOVA|||||-2.26|-6.32|<0.0001
72502155|NCT00811252|144534447|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.35|STANDARD_ERROR_OF_MEAN|0.74||0.0015|TWO_SIDED|95.0|-3.8|-0.91||A nominal p-value is provided. No correction for multiplicity was made.|ANCOVA|||||-0.91|-3.80|0.0015
72502156|NCT00811252|144534448|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-0.88|-0.32||A nominal p-value is provided. No correction for multiplicity was made.|ANCOVA|||||-0.32|-0.88|<0.0001
72502157|NCT00811252|144534449|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.56|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-0.82|-0.31||A nominal p-value is provided. No correction for multiplicity was made.|ANCOVA|||||-0.31|-0.82|<0.0001
72502158|NCT00811252|144534450|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.44|STANDARD_ERROR_OF_MEAN|0.23||0.0552|TWO_SIDED|95.0|-0.88|0.01||A nominal p-value is provided. No correction for multiplicity was made.|ANCOVA|||||0.01|-0.88|0.0552
72393931|NCT01059825|144294277|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.37||||0|TWO_SIDED|80.0|-0.5|-0.23||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p \<0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-0.23|-0.50|0.000
72502159|NCT00811252|144534451|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.43||||0.0008|TWO_SIDED|95.0|0.26|0.7||A nominal p-value is provided. No correction for multiplicity was made.|Regression, Logistic|||||0.70|0.26|0.0008
72502160|NCT00811252|144534452|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.47||||0.009|TWO_SIDED|95.0|0.27|0.83||A nominal p-value is provided. No correction for multiplicity was made.|Regression, Logistic|||||0.83|0.27|0.0090
72502161|NCT01486264|144534454|NON_INFERIORITY|Analysis of covariance (ANCOVA) model adjusted for the baseline TWSTRS Severity subscale score, was used to test the non-inferiority of Short Flex versus Long Flex treatment. Non-inferiority margin delta equal to (=) 2 points.|Least Square (LS) Mean difference|-1.4|STANDARD_ERROR_OF_MEAN|0.75|||TWO_SIDED|95.0|-2.9|0.1||||||||0.1|-2.9|
72502162|NCT04871815|144534517|SUPERIORITY|||||||0.2|||||||Wilcoxon (Mann-Whitney)|||Body Aches||||0.200
72502163|NCT04871815|144534517|SUPERIORITY|||||||0.0326|||||||Wilcoxon (Mann-Whitney)|||Headaches||||0.0326
72502164|NCT04871815|144534517|SUPERIORITY|||||||0.0043|||||||Wilcoxon (Mann-Whitney)|||Coughing/Sneezing||||0.0043
72502165|NCT04871815|144534517|SUPERIORITY|||||||0.0003|||||||Wilcoxon (Mann-Whitney)|||Trouble Breathing||||0.0003
72502166|NCT04871815|144534517|SUPERIORITY|||||||0.3714|||||||Wilcoxon (Mann-Whitney)|||Congestion||||0.3714
72502167|NCT04871815|144534517|SUPERIORITY|||||||0.3|||||||Wilcoxon (Mann-Whitney)|||Fatigue||||0.300
72502168|NCT04871815|144534517|SUPERIORITY|||||||0.2286|||||||Wilcoxon (Mann-Whitney)|||Loss of Smell/Taste||||0.2286
72393932|NCT01059825|144294277|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.45||||0|TWO_SIDED|80.0|-0.59|-0.32||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p \<0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-0.32|-0.59|0.000
72463753|NCT02642159|144450258|SUPERIORITY||LS Mean Difference|-33.3|||<|0.0001|TWO_SIDED|97.5|-46.6|-19.9||Threshold for significance \<=0.025.|Mixed Models Analysis||Alirocumab (intent to prescribe fenofibrate) vs. usual care (intent to prescribe fenofibrate)|Alirocumab group was compared to usual care group for the intent to prescribe fenofibrate using an appropriate contrast statement.||-19.9|-46.6|<0.0001
72463754|NCT02642159|144450259|SUPERIORITY||LS Mean Difference|-43.0|||<|0.0001|TWO_SIDED|97.5|-49.7|-36.3||Threshold for significance \<=0.025.|Mixed Models Analysis||Alirocumab vs. usual care|A hierarchical testing procedure was used to control type I error and handle multiple secondary endpoint analyses for overall ITT analysis. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when previous endpoint was statistically significant at 0.025 level.||-36.3|-49.7|<0.0001
72463755|NCT02642159|144450260|SUPERIORITY||LS Mean Difference|-55.7|||<|0.0001|TWO_SIDED|97.5|-71.8|-39.6||Threshold for significance \<=0.025.|Mixed Models Analysis||Alirocumab (intent to prescribe fenofibrate) vs. usual care (intent to prescribe fenofibrate)|A separate hierarchical testing procedure was used to control type I error and handle multiple secondary endpoint analyses for ITT-intent to prescribe fenofibrate stratum. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when previous endpoint was statistically significant at 0.025 level.||-39.6|-71.8|<0.0001
72463756|NCT02642159|144450261|SUPERIORITY||LS Mean Difference|-26.1|||<|0.0001|TWO_SIDED|97.5|-31.5|-20.7||Threshold for significance \<=0.025.|Mixed Models Analysis||Alirocumab vs. usual care|Testing according to the hierarchical testing procedure (only performed if the previous endpoint of overall ITT analysis was statistically significant).||-20.7|-31.5|<0.0001
72463757|NCT02642159|144450262|SUPERIORITY||LS Mean Difference|-27.4|||<|0.0001|TWO_SIDED|97.5|-40.0|-14.8||Threshold for significance \<=0.025.|Mixed Models Analysis||Alirocumab (intent to prescribe fenofibrate) vs. usual care (intent to prescribe fenofibrate)|Testing according to the hierarchical testing procedure (only performed if the previous endpoint of ITT-intent to prescribe fenofibrate stratum was statistically significant).||-14.8|-40.0|<0.0001
72502169|NCT04871815|144534517|SUPERIORITY|||||||0.999|||||||Wilcoxon (Mann-Whitney)|||Anxiety||||0.999
72502170|NCT04871815|144534518|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
72502171|NCT04871815|144534519|SUPERIORITY|||||||0.1963|||||||ANOVA|||||||0.1963
72393933|NCT01059825|144294277|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.44||||0|TWO_SIDED|80.0|-0.57|-0.3||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p \<0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-0.30|-0.57|0.000
72463758|NCT02642159|144450263|SUPERIORITY||LS Mean Difference|-34.7|||<|0.0001|TWO_SIDED|97.5|-40.8|-28.6||Threshold for significance \<=0.025.|Mixed Models Analysis||Alirocumab vs. usual care|Testing according to the hierarchical testing procedure (only performed if the previous endpoint of overall ITT analysis was statistically significant).||-28.6|-40.8|<0.0001
72463759|NCT02642159|144450264|SUPERIORITY||LS Mean Difference|-49.7|||<|0.0001|TWO_SIDED|97.5|-63.7|-35.8||Threshold for significance \<=0.025.|Mixed Models Analysis||Alirocumab (intent to prescribe fenofibrate) vs. usual care (intent to prescribe fenofibrate)|Testing according to the hierarchical testing procedure (only performed if the previous endpoint of ITT-intent to prescribe fenofibrate stratum was statistically significant).||-35.8|-63.7|<0.0001
72463760|NCT02642159|144450265|SUPERIORITY||LS Mean Difference|-32.3|||<|0.0001|TWO_SIDED|97.5|-37.3|-27.2||Threshold for significance \<=0.025.|Mixed Models Analysis||Alirocumab vs. usual care|Testing according to the hierarchical testing procedure (only performed if the previous endpoint of overall ITT analysis was statistically significant).||-27.2|-37.3|<0.0001
72502172|NCT04871815|144534520|SUPERIORITY||||||<|0.0001|||||||ANOVA|||||||<0.0001
72502173|NCT04871815|144534520|SUPERIORITY|||||||0.0008||||||Tukey's Multiple comparison test (p-value is adjusted for multiple comparisons)|Tukey's HSD|||Day 1 baseline (day 1 of study) vs Day 1 treatment (day 7 of study).||||0.0008
72502174|NCT04871815|144534520|SUPERIORITY||||||<|0.0001||||||Tukey's Multiple comparison test (p-value is adjusted for multiple comparisons)|Tukey's HSD|||Day 1 baseline (day 1 of study) vs Day 7 treatment (day 14 of study).||||<0.0001
72502175|NCT04871815|144534520|SUPERIORITY|||||||0.0114||||||Tukey's Multiple comparison test (p-value is adjusted for multiple comparisons)|Tukey's HSD|||Day 7 baseline (day 7 of study) vs Day 1 treatment (day 7 of study).||||0.0114
72502176|NCT04871815|144534520|SUPERIORITY||||||<|0.0001||||||Tukey's Multiple comparison test (p-value is adjusted for multiple comparisons)|Tukey's HSD|||Day7 baseline (day 7 of study) vs Day 7 treatment (day 14 of study)||||<0.0001
72502177|NCT02120417|144534521|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.932||||0.762|TWO_SIDED|80.0|0.694|1.252|||Log Rank|The P-value was analyzed by Log-Rank Test stratified by Hormone Receptor Status.||||1.252|0.694|0.762
72502178|NCT00594399|144534530|SUPERIORITY_OR_OTHER|||||||0.43|TWO_SIDED|||||Omnibus test of difference between groups over time with Bonferroni correction and adjustment for baseline value of insulin|Mixed Models Analysis|||||||0.43
72502179|NCT00594399|144534533|SUPERIORITY_OR_OTHER|||||||0.91|TWO_SIDED|||||Omnibus test of difference between groups over time with Bonferroni correction and adjustment for baseline value of glucose|Mixed Models Analysis|||||||0.91
72502180|NCT00594399|144534536|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Omnibus test of difference between groups over time with adjustment for baseline value of physical activity|Mixed Models Analysis|||||||<0.001
72393934|NCT01059825|144294277|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.36||||0|TWO_SIDED|80.0|-0.49|-0.22||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p \<0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-0.22|-0.49|0.000
72463761|NCT02642159|144450266|SUPERIORITY||LS Mean Difference|-35.2|||<|0.0001|TWO_SIDED|97.5|-47.4|-22.9||Threshold for significance \<=0.025.|Mixed Models Analysis||Alirocumab (intent to prescribe fenofibrate) vs. usual care (intent to prescribe fenofibrate)|Testing according to the hierarchical testing procedure (only performed if the previous endpoint of ITT- intent to prescribe fenofibrate stratum was statistically significant).||-22.9|-47.4|<0.0001
72463762|NCT02642159|144450267|SUPERIORITY||LS Mean Difference|-24.6|||<|0.0001|TWO_SIDED|97.5|-28.8|-20.3||Threshold for significance \<=0.025.|Mixed Models Analysis||Alirocumab vs. usual care|Testing according to the hierarchical testing procedure (only performed if the previous endpoint of overall ITT analysis was statistically significant).||-20.3|-28.8|<0.0001
72463763|NCT02642159|144450268|SUPERIORITY||LS Mean Difference|-25.3|||<|0.0001|TWO_SIDED|97.5|-35.4|-15.1||Threshold for significance \<=0.025.|Mixed Models Analysis||Alirocumab (intent to prescribe fenofibrate) vs. usual care (intent to prescribe fenofibrate)|Testing according to the hierarchical testing procedure (only performed if the previous endpoint of ITT- intent to prescribe fenofibrate stratum was statistically significant).||-15.1|-35.4|<0.0001
72463764|NCT02642159|144450269|SUPERIORITY||Adjusted Mean Difference|-27.4|||<|0.0001|TWO_SIDED|97.5|-34.6|-20.1||Threshold for significance \<=0.025.|Regression, Robust|Multiple imputation approach followed by robust regression model.|Alirocumab vs. usual care|Testing according to the hierarchical testing procedure (only performed if the previous endpoint of overall ITT analysis was statistically significant).||-20.1|-34.6|<0.0001
72463765|NCT02642159|144450270|SUPERIORITY||Adjusted Mean Difference|-22.8||||0.004|TWO_SIDED|97.5|-40.6|-5.0||Threshold for significance \<=0.025.|Regression, Robust|Multiple imputation approach followed by robust regression model.|Alirocumab (intent to prescribe fenofibrate) vs. usual care (intent to prescribe fenofibrate)|Testing according to the hierarchical testing procedure (only performed if the previous endpoint of ITT- intent to prescribe fenofibrate stratum was statistically significant).||-5.0|-40.6|0.0040
72463766|NCT02642159|144450271|SUPERIORITY||Adjusted Mean Difference|-4.2||||0.2191|TWO_SIDED|97.5|-11.8|3.4||Threshold for significance \<=0.025.|Regression, Robust|Multiple imputation approach followed by robust regression.|Alirocumab vs. usual care|Testing according to the hierarchical testing procedure (only performed if the previous endpoint of overall ITT analysis was statistically significant).||3.4|-11.8|0.2191
72463767|NCT02642159|144450272|SUPERIORITY||Adjusted Mean Difference|9.0||||0.2651|TWO_SIDED|97.5|-9.1|27.1||Threshold for significance \<=0.025.|Regression, Robust|Multiple imputation approach followed by robust regression.||Testing according to the hierarchical testing procedure (only performed if the previous endpoint of ITT- intent to prescribe fenofibrate stratum was statistically significant).|Alirocumab (intent to prescribe fenofibrate) vs. usual care (intent to prescribe fenofibrate)|27.1|-9.1|0.2651
72463768|NCT01350388|144450313|SUPERIORITY_OR_OTHER|||||||0.84|||||||ANCOVA|||||||0.84
72463769|NCT01350388|144450314|SUPERIORITY_OR_OTHER|||||||0.73|||||||ANCOVA|||||||0.73
72563844|NCT04025684|144659052|SUPERIORITY||Adjusted Mean Change|-0.1|STANDARD_ERROR_OF_MEAN|0.01|<|0.0001|TWO_SIDED|95.0|-0.12|-0.08||Analysis was performed using ANCOVA model with product group as a fixed effect and the baseline mean RPI overall value as a covariate.|ANCOVA|||Statistical analysis was performed with comparison in pre-treatment and post-treatment within the treatment group.||-0.08|-0.12|<0.0001
72463770|NCT01350388|144450315|SUPERIORITY_OR_OTHER|||||||0.23|||||||ANCOVA|||||||0.23
72463771|NCT01350388|144450316|SUPERIORITY_OR_OTHER|||||||0.88|||||||ANCOVA|||||||0.88
72463772|NCT01350388|144450317|SUPERIORITY_OR_OTHER|||||||0.13|||||||ANCOVA|||||||0.13
72463773|NCT01350388|144450318|SUPERIORITY_OR_OTHER|||||||0.35|||||||ANCOVA|||||||0.35
72393935|NCT01059825|144294277|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.44||||0|TWO_SIDED|80.0|-0.57|-0.3||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p \<0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-0.30|-0.57|0.000
72393936|NCT01059825|144294278|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.47||||0|TWO_SIDED|80.0|-0.64|-0.3||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p \<0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-0.30|-0.64|0.000
72463774|NCT03640754|144450320|SUPERIORITY||||||<|0.001|||||||t-test, 1 sided|||||||<0.001
72463775|NCT03640754|144450320|SUPERIORITY||||||<|0.001|||||||t-test, 1 sided|||||||<0.001
72463776|NCT03640754|144450321|SUPERIORITY||||||<|0.001|||||||t-test, 1 sided|||||||<0.001
72463777|NCT03640754|144450321|SUPERIORITY||||||<|0.001|||||||t-test, 1 sided|||||||<0.001
72463778|NCT03640754|144450322|SUPERIORITY||||||<|0.001|||||||t-test, 1 sided|||||||<0.001
72463779|NCT03640754|144450322|SUPERIORITY||||||<|0.001|||||||t-test, 1 sided|||||||<0.001
72463780|NCT03640754|144450323|SUPERIORITY|||||||0.199|||||||t-test, 1 sided|||||||0.199
72463781|NCT03640754|144450323|SUPERIORITY|||||||0.189|||||||t-test, 1 sided|||||||0.189
72463782|NCT03640754|144450324|SUPERIORITY|Least squares means (LS Means) from a mixed effects repeated measures model with baseline M+S score, current smoking status, bmi, and parity as covariates||||||0.398|||||||Mixed Models Analysis|||||||0.398
72563845|NCT04025684|144659052|SUPERIORITY||Adjusted Mean Change|-0.1|STANDARD_ERROR_OF_MEAN|0.01|<|0.0001|TWO_SIDED|95.0|-0.12|-0.08||Analysis was performed using ANCOVA model with product group as a fixed effect and the baseline mean RPI overall value as a covariate.|ANCOVA|||Statistical analysis was performed with comparison in pre-treatment and post-treatment within the treatment group.||-0.08|-0.12|<0.0001
72463783|NCT03640754|144450324|SUPERIORITY|Least squares means (LS Means) from a mixed effects repeated measures model with baseline M+S score, current smoking status, bmi, and parity as covariates||||||0.391|||||||Mixed Models Analysis|||||||0.391
72463784|NCT03640754|144450325|SUPERIORITY|||||||0.232|||||||Mixed Models Analysis|||Least squares means (LS Means) from a mixed effects repeated measures model with baseline M+S score, current smoking status, bmi, and parity as covariates||||0.232
72463785|NCT03640754|144450325|SUPERIORITY|||||||0.085|||||||Mixed Models Analysis|||Least squares means (LS Means) from a mixed effects repeated measures model with baseline M+S score, current smoking status, bmi, and parity as covariates||||0.085
72463786|NCT03640754|144450326|SUPERIORITY|||||||0.501|||||||Mixed Models Analysis|||||||0.501
72463787|NCT03640754|144450326|SUPERIORITY|||||||0.37|||||||Mixed Models Analysis|||||||0.370
72463788|NCT03640754|144450327|SUPERIORITY|||||||0.333|||||||Mixed Models Analysis|||||||0.333
72463789|NCT03640754|144450327|SUPERIORITY|||||||0.014|||||||Mixed Models Analysis|||||||0.014
72463790|NCT03640754|144450328|SUPERIORITY|||||||0.124|||||||Mixed Models Analysis|||||||0.124
72463791|NCT03640754|144450328|SUPERIORITY|||||||0.175|||||||Mixed Models Analysis|||||||0.175
72463792|NCT03640754|144450329|SUPERIORITY|||||||0.032|||||||Mixed Models Analysis|||||||0.032
72463793|NCT03640754|144450329|SUPERIORITY|||||||0.077|||||||Mixed Models Analysis|||||||0.077
72463794|NCT03640754|144450333|SUPERIORITY|||||||0.047|||||||t-test, 1 sided|||||||0.047
72463795|NCT03640754|144450333|SUPERIORITY|||||||0.139|||||||t-test, 1 sided|||||||0.139
72502181|NCT00613626|144534692|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|3.0|STANDARD_ERROR_OF_MEAN|22.718||0.1|ONE_SIDED|90.0|||||Log Rank|||A one-sided log rank test with an overall sample size of 68 subjects (of which 34 are in arm A and 34 are in arm B) achieves 80% power at a 0.10 significance level to detect a difference of 3 months in PFS between 4 month median PFS and 7 month median PFS.||||0.10
72502182|NCT00613626|144534692|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9518|TWO_SIDED|||||P-Value (2-tailed) is calculated based on the unstratified log-rank test.|Log Rank|Degrees of freedom=1||||||0.9518
72463796|NCT03640754|144450333|SUPERIORITY|||||||0.395|||||||t-test, 1 sided|||||||0.395
72463797|NCT03640754|144450334|SUPERIORITY|||||||0.147|||||||t-test, 1 sided|||||||0.147
72463798|NCT03640754|144450334|SUPERIORITY|||||||0.16|||||||t-test, 1 sided|||||||0.160
72463799|NCT03640754|144450334|SUPERIORITY|||||||0.152|||||||t-test, 1 sided|||||||0.152
72463800|NCT03640754|144450335|SUPERIORITY|||||||0.286|||||||t-test, 1 sided|||||||0.286
72463801|NCT03640754|144450335|SUPERIORITY|||||||0.107|||||||t-test, 1 sided|||||||0.107
72621216|NCT02732145|144773186|EQUIVALENCE|Question: Is there a difference in the incidence of constipation between patients from different groups?||||||0.0379|||||||Chi-squared|||Parameter: The difference in the incidence of constipation between patients from different groups.||||0.0379
72463802|NCT03640754|144450336|SUPERIORITY|||||||0.289|||||||t-test, 1 sided|||||||0.289
72463803|NCT03640754|144450336|SUPERIORITY|||||||0.338|||||||t-test, 1 sided|||||||0.338
72463804|NCT03640754|144450337|SUPERIORITY|||||||0.393|||||||t-test, 1 sided|||||||0.393
72463805|NCT03640754|144450337|SUPERIORITY|||||||0.365|||||||t-test, 1 sided|||||||0.365
72463806|NCT03640754|144450338|SUPERIORITY|||||||0.406|||||||t-test, 1 sided|||||||0.406
72463807|NCT03640754|144450338|SUPERIORITY|||||||0.494|||||||t-test, 1 sided|||||||0.494
72463808|NCT05329402|144450339|NON_INFERIORITY|"The non-inferiority hypothesis is tenable if the lower limit of 95% confidence interval of the difference in the primary effectiveness evaluation indicator device cutting and anastomosis success rate between the test group and the control group is greater than the non-inferiority critical value (-10%)."|Mean Difference (Final Values)|0.0||||0.9727|TWO_SIDED|95.0|-0.0285|0.0273|||Wald|||||0.0273|-0.0285|0.9727
72463809|NCT01679613|144450343|SUPERIORITY_OR_OTHER||Geometric Mean Ratio in percentage|160.48|STANDARD_DEVIATION|17.9||1|TWO_SIDED|90.0|148.245|173.736||p-value for ratio outside interval 0.8 - 1.25|ANOVA|The model includes fixed effects for sequence, period, and treatment. Subjects within sequences is included as random effect.|"Ratio calculated as nintedanib+ketoconazole divided by nintedanib (in %).~The standard deviation is actually the geometric coefficient of variation (gCV)."|||173.736|148.245|1.0000
72463810|NCT01679613|144450344|SUPERIORITY_OR_OTHER||Geometric Mean Ratio in percentage|179.62|STANDARD_DEVIATION|29.9||1|TWO_SIDED|90.0|157.557|204.779||p-value for ratio outside interval 0.8 - 1.25|ANOVA|The model includes fixed effects for sequence, period, and treatment. Subjects within sequences is included as random effect.|"The standard deviation is actually the gCV (in %).~Ratio calculated as nintedanib+ketoconazole divided by nintedanib"|||204.779|157.557|1.0000
72463811|NCT01679613|144450345|SUPERIORITY_OR_OTHER||Geometric Mean Ratio in percentage|168.09|STANDARD_DEVIATION|17.9||1|TWO_SIDED|90.0|155.252|181.981||p-value for ratio outside interval 0.8 to 1.25|ANOVA|The model includes fixed effects for sequence, period, and treatment. Subjects within sequences is included as random effect.|"The standard deviation is actually the gCV.~Ratio calculated as nintedanib+ketoconazole divided by nintedanib (in %)."|||181.981|155.252|1.000
72502183|NCT00613626|144534694|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2533|TWO_SIDED||||||Difference in Rates|P-value (two-tailed) is calculated based on an unadjusted, normal-distribution approximation for the difference in rates.||||||0.2533
72502184|NCT00613626|144534695|SUPERIORITY_OR_OTHER_LEGACY|||||||0.872|TWO_SIDED||||||Difference in Rates|||||||0.8720
72502185|NCT00613626|144534696|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4577|TWO_SIDED||||||Log Rank|||||||0.4577
72502186|NCT00613626|144534697|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|0.05|||||TWO_SIDED|95.0|||||||Survival analysis of VEGF variants using cox proportional hazard analysis in arm A and arm B.|Data was not collected for safety lead-in participants and these participants were not included in the analysis.||||
72502187|NCT00613626|144534697|SUPERIORITY_OR_OTHER_LEGACY||Logistic Regression Analysis|0.05|||||TWO_SIDED|95.0|||||||Objective Response Analysis of VEGF variants using Logistic Regression Analysis in arm A and arm B|||||
72502188|NCT03040154|144534706|SUPERIORITY||Odds Ratio (OR)|2.67||||0.006|TWO_SIDED|95.0|1.33|5.35|||Regression, Logistic|||||5.35|1.33|0.006
72621217|NCT02732145|144773186|EQUIVALENCE|Question: Is there a difference in the incidence of intermittent constipation between patients from different groups?||||||0.1485|||||||Chi-squared|||Parameter: The difference in the incidence of intermittent constipation between patients from different groups.||||0.1485
72463812|NCT00230971|144450393|NON_INFERIORITY_OR_EQUIVALENCE|A 2-sided 95% CI (corrected for continuity) was calculated for the true difference between the cure rates. Non-inferiority will be concluded if the lower limit of the 2-sided CI is greater than -15%.|Risk Difference (RD)|1.6||||||95.0|-6.4|9.6|||t-test, 1 sided||Estimates of the difference, CI and hypothesis tests are weighted by using minimum risk weights.|||9.6|-6.4|
72463813|NCT00230971|144450394|NON_INFERIORITY_OR_EQUIVALENCE|A 2-sided 95% CI (corrected for continuity) was calculated for the true difference between the cure rates. Non-inferiority will be concluded if the lower limit of the 2-sided CI is greater than -15%.|Risk Difference (RD)|1.8||||0.001||95.0|-8.8|12.5|||t-test, 1 sided||Estimates of the difference, CI and hypothesis tests are weighted by using minimum risk weights.|||12.5|-8.8|0.001
72463814|NCT00230971|144450395|NON_INFERIORITY_OR_EQUIVALENCE|A 2-sided 95% CI (corrected for continuity) was calculated for the true difference between the cure rates. Non-inferiority will be concluded if the lower limit of the 2-sided CI is greater than -15%.|Risk Difference (RD)|2.7||||||95.0|-7.9|13.3|||t-test, 1 sided||Estimates of the difference, CI and hypothesis tests are weighted by using minimum risk weights.|Group comparison of eradication + presumed eradication||13.3|-7.9|
72463815|NCT00230971|144450396|SUPERIORITY_OR_OTHER|||||||0.75|||||||ANOVA|Treatment as a factor||Overall inpatient hospitalization||||0.750
72463816|NCT00230971|144450396|SUPERIORITY_OR_OTHER|||||||0.655|||||||ANOVA|Treatment as a factor||Primary inpatient hospitalization||||0.655
72463817|NCT00230971|144450396|SUPERIORITY_OR_OTHER|||||||0.191|||||||ANOVA|Treatment as a factor||ICU treatment||||0.191
72463818|NCT00230971|144450396|SUPERIORITY_OR_OTHER|||||||0.717|||||||ANOVA|Treatment as a factor||Inpatient hospitalization, non-ICU||||0.717
72502189|NCT03542682|144534709|SUPERIORITY||Mean Difference (Final Values)|-55.67|||||TWO_SIDED|95.0|-124.63|13.3|||Mixed Models Analysis|The model adjusted for order of the clamps and accounting for within subject correlation.||||13.30|-124.63|
72502190|NCT03542682|144534711|SUPERIORITY||Mean Difference (Final Values)|0.96|||||TWO_SIDED|95.0|-1.1|3.02|||Mixed Models Analysis|The model adjusted for order of the clamps and accounting for within subject correlation.||||3.02|-1.10|
72502191|NCT03542682|144534712|SUPERIORITY||Mean Difference (Final Values)|131.85|||||TWO_SIDED|95.0|-246.7|510.41|||Mixed Models Analysis|The model adjusted for order of the clamps and accounting for within subject correlation.||||510.41|-246.70|
72463819|NCT01699698|144450421|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<0.001
72463820|NCT02151643|144450433|OTHER|The primary analysis was a linear model which attempted to explain change from Baseline (Visit 7) to Day 29 (Visit 11) in serum phosphate concentration based on log-transformed dose level (assuming that placebo was equally spaced below the lowest dose level), and stratified by pre-randomisation serum phosphate level (\< 7.5 mg/dL or ≥ 7.5 mg/dL). Missing assessments were imputed using the subject's last observed phosphate concentration value (Last Observation Carried Forward \[LOCF\] imputation).||||||0.784|||||||F-test|||"ITT population - statistical analysis of linear model fit using an F-test at the 0.05 level.~It was determined that 150 subjects randomised at a ratio of 8:8:8:13:13 (low dose to high dose, placebo) would have \>90% power to detect either a statistically significant slope for the dose-response relationship, or, if the relationship was not linear, a statistically significant difference between the highest-dose group and the placebo group, using a two-sided 0.05 significance level."||||0.784
72502192|NCT03232073|144534721|SUPERIORITY||Treatment Effect (Rate Ratio)|0.779||||||95.0|0.629|0.965||||||||0.965|0.629|
72502193|NCT01672892|144534778|SUPERIORITY|||||||0.0476|||||||t-test, 1 sided|||Since there is no prior data using this tool in this patient population, an effect size of 0.4 was chosen to calculate sample size. Based on a two-sample t-test with one interim look and a two-sided alpha=0.05, a sample size of 225 is needed to achieve 85% statistical power. Assuming an attrition rate of 10% and noncompliance of 10%, 281 patients were required in order to ensure 225 evaluable patients for the primary endpoint analysis.||||0.0476
72502194|NCT01672892|144534779|SUPERIORITY|||||||0.4338|||||||Binomial test of proportions|2-sided significance level = 0.05||||||0.4338
72502195|NCT01672892|144534780|SUPERIORITY|||||||0.04|||||||t-test, 2 sided|2-sided significance level of 0.05||Week 3 of RT||||0.04
72502196|NCT01672892|144534780|SUPERIORITY|||||||0.03|||||||t-test, 2 sided|2-sided significance level of 0.05||Week 5 of RT||||0.03
72502197|NCT01672892|144534780|SUPERIORITY|||||||0.41|||||||t-test, 2 sided|2-sided significance level of 0.05||4-6 weeks post-RT||||0.41
72502198|NCT01672892|144534781|SUPERIORITY|||||||0.54|||||||t-test, 2 sided|2-sided significance level = 0.05||FACT-G total score - 5 weeks||||0.54
72502199|NCT01672892|144534781|SUPERIORITY|||||||0.72|||||||t-test, 2 sided|FACT-G total score - 4-6 weeks post RT||FACT-G total score - 4-6 weeks post RT||||0.72
72502200|NCT01672892|144534781|SUPERIORITY|||||||0.01|||||||t-test, 2 sided|2-sided significance level = 0.05||FACT-Cx subscale score - 5 weeks||||0.01
72502201|NCT01672892|144534781|SUPERIORITY|||||||0.45|||||||t-test, 2 sided|2-sided significance level = 0.05||FACT-Cx subscale score - 4-6 weeks post RT||||0.45
72502202|NCT01672892|144534781|SUPERIORITY|||||||0.03|||||||t-test, 2 sided|2-sided significance level = 0.0125||Physical subscale score - 5 weeks||||0.03
72502203|NCT01672892|144534781|SUPERIORITY|||||||0.9|||||||t-test, 2 sided|2-sided significance level = 0.0125||Physical subscale score - 4-6 weeks post RT||||0.9
72502204|NCT01672892|144534781|SUPERIORITY|||||||0.55|||||||t-test, 2 sided|2-sided significance level = 0.0125||Functional subscale score - 5 weeks||||0.55
72502205|NCT01672892|144534781|SUPERIORITY|||||||0.35|||||||t-test, 2 sided|2-sided significance level = 0.0125||Functional subscale score - 4-6 weeks post RT||||0.35
72502206|NCT01672892|144534781|SUPERIORITY|||||||0.66|||||||t-test, 2 sided|2-sided significance level = 0.0125||Emotional subscale score - 5 weeks||||0.66
72502207|NCT01672892|144534781|SUPERIORITY|||||||0.09|||||||t-test, 2 sided|2-sided significance level = 0.0125||Emotional subscale score - 4-6 weeks post RT||||0.09
72502208|NCT01672892|144534781|SUPERIORITY|||||||0.66|||||||t-test, 2 sided|2-sided significance level = 0.0125||Social subscale score - 5 weeks||||0.66
72502209|NCT01672892|144534781|SUPERIORITY|||||||0.35|||||||t-test, 2 sided|2-sided significance level = 0.0125||Social subscale score - 4-6 weeks post RT||||0.35
72502210|NCT01672892|144534782|SUPERIORITY|||||||0.61|||||||t-test, 2 sided|2-sided significance level = 0.05||5 weeks||||0.61
72502211|NCT01672892|144534782|SUPERIORITY|||||||0.67|||||||t-test, 2 sided|2-sided significance level = 0.05||4-6 weeks post-RT||||0.67
72502212|NCT01672892|144534783|SUPERIORITY|||||||0.81|||||||Gray's test|Two-sided significance level = 0.05||||||0.81
72463821|NCT02151643|144450433|OTHER|Sensitivity analysis of ITT primary analysis using baseline observation carried forward (BOCF) for any missing Day 29 (Visit 11) serum phosphate values.||||||0.905|||||||F-test|||"ITT population sensitivity analysis using baseline observation carried forward (BOCF) to assess statistical analysis of linear model fit using an F-test at the 0.05 level."||||0.905
72463822|NCT02151643|144450433|OTHER|Sensitivity analysis of ITT primary analysis using multiple imputation (MI) for any missing Day 29 (Visit 11) serum phosphate values.||||||0.976|||||||F-test|||"ITT population sensitivity analysis using multiple imputation (MI) to assess statistical analysis of linear model fit using an F-test at the 0.05 level."||||0.976
72463823|NCT02151643|144450433|OTHER|Sensitivity analysis of the primary ITT analysis using the Per Protocol (PP) population.||||||0.914|||||||F-test|||"Per protocol (PP) population sensitivity analysis to assess statistical analysis of linear model fit using an F-test at the 0.05 level."||||0.914
72463824|NCT02151643|144450433|OTHER|The primary analysis was a linear model which attempted to explain change from Baseline (Visit 7) to Day 29 (Visit 11) in serum phosphate concentration based on log-transformed dose level (assuming that placebo was equally spaced below the lowest dose level), and stratified by pre-randomisation serum phosphate level (\< 7.5 mg/dL or ≥ 7.5 mg/dL). Missing assessments were imputed using the subject's last observed phosphate concentration value (Last Observation Carried Forward \[LOCF\] imputation).|Slope|-0.329|||<|0.001|TWO_SIDED||||||linear model - log (dose) - response|||ITT population - statistical analysis of the linear model log(PT20 dose)-response relationship to examine whether the linear trend of the change in phosphate level as a function of the log-transformed dose was statistically significant.||||<0.001
72463825|NCT02151643|144450433|OTHER||||||<|0.001|||||||Mixed Models Analysis|||ITT population supportive analysis - Type 3 tests of fixed effects - treatment group||||<0.001
72463826|NCT02151643|144450433|OTHER|||||||0.436|||||||Mixed Models Analysis|||ITT population supportive analysis - Type 3 tests of fixed effects - visit||||0.436
72463827|NCT02151643|144450433|OTHER|||||||0.959|||||||Mixed Models Analysis|||ITT population supportive analysis - Type 3 tests of fixed effects - treatment group versus Visit interaction||||0.959
72502213|NCT01672892|144534784|SUPERIORITY||Hazard Ratio (HR)|1.39||||0.21|TWO_SIDED|95.0|0.82|2.35|||Log Rank|Two-side significance level = 0.05|Reference level = Intensity-Modulated Radiation Therapy|||2.35|0.82|0.21
72502214|NCT01672892|144534785|SUPERIORITY||Hazard Ratio (HR)|0.76||||0.53|TWO_SIDED|95.0|0.32|1.79|||Log Rank|Two-sided significance level = 0.05|Reference level = Intensity-Modulated Radiation Therapy|||1.79|0.32|0.53
72502215|NCT01672892|144534788|OTHER||||||<|0.0001|||||||nonparametric one-sample t-test|||Baseline||||<0.0001
72563846|NCT04025684|144659053|SUPERIORITY||Adjusted Mean Change|-0.5|STANDARD_ERROR_OF_MEAN|0.065|<|0.0001|TWO_SIDED|95.0|-0.62|-0.37||Analysis was performed using ANCOVA model with product group as a fixed effect, and the baseline mean TPI overall value and RPI stratification level as covariates.|ANCOVA|||Statistical analysis was performed with comparison in pre-treatment and post-treatment within the treatment group.||-0.37|-0.62|<0.0001
72563847|NCT04025684|144659053|SUPERIORITY||Adjusted Mean Change|-0.62|STANDARD_ERROR_OF_MEAN|0.066|<|0.0001|TWO_SIDED|95.0|-0.75|-0.49||Analysis was performed using ANCOVA model with product group as a fixed effect, and the baseline mean TPI overall value and RPI stratification level as covariates.|ANCOVA|||Statistical analysis was performed with comparison in pre-treatment and post-treatment within the treatment group.||-0.49|-0.75|<0.0001
72563848|NCT04025684|144659053|SUPERIORITY||Adjusted Mean Change|-0.55|STANDARD_ERROR_OF_MEAN|0.066|<|0.0001|TWO_SIDED|95.0|-0.68|-0.42||Analysis was performed using ANCOVA model with product group as a fixed effect, and the baseline mean TPI overall value and RPI stratification level as covariates.|ANCOVA|||Statistical analysis was performed with comparison in pre-treatment and post-treatment within the treatment group.||-0.42|-0.68|<0.0001
72621218|NCT02732145|144773186|EQUIVALENCE|Question: Is there a difference in the incidence of frequent constipation between patients from different groups?||||||0.4155|||||||Chi-squared|||Parameter: The difference in the incidence of frequent constipation between patients from different groups.||||0.4155
72621219|NCT02732145|144773186|EQUIVALENCE|Question: Is there a difference in the incidence of diarrhea between patients from different groups?||||||0.0092|||||||Chi-squared|||Parameter: The difference in the incidence of diarrhea between patients from different groups.||||0.0092
72463828|NCT02151643|144450433|OTHER||||||<|0.001|||||||Mixed Models Analysis|||ITT population supportive analysis - Type 3 tests of fixed effects - baseline serum phosphate concentration||||<0.001
72463829|NCT02151643|144450433|OTHER|||||||0.144|||||||Mixed Models Analysis|||ITT population supportive analysis - Type 3 tests of fixed effects - baseline serum phosphate concentration versus Visit interaction||||0.144
72463830|NCT02151643|144450433|OTHER||Mean Difference (Final Values)|0.117|STANDARD_ERROR_OF_MEAN|0.2847|||ONE_SIDED|97.5||0.761||||||ITT population supportive analysis - mixed model repeated measures for change in serum phosphate concentration||0.761||
72502216|NCT01672892|144534788|OTHER||||||<|0.0001|||||||nonparametric one-sample t-test|||Week 5||||<0.0001
72502217|NCT01672892|144534789|OTHER||||||<|0.0001|||||||One-sample t-test|||Bowel domain at baseline||||<0.0001
72502218|NCT01672892|144534789|OTHER||||||<|0.0001|||||||One-sample t-test|||Bowel domain at week 5||||<0.0001
72502219|NCT01672892|144534789|OTHER||||||<|0.0001|||||||One-sample t-test|||Urinary domain at baseline||||<0.0001
72502220|NCT01672892|144534789|OTHER||||||<|0.0001|||||||One-sample t-test|||Urinary domain at week 5||||<0.0001
72502221|NCT01672892|144534790|OTHER||||||<|0.0001|||||||Paired t-test|||Bowel domain||||<0.0001
72502222|NCT01672892|144534790|OTHER||||||<|0.0001|||||||Paired t-test|||Urinary domain||||<0.0001
72502223|NCT00914628|144534832|SUPERIORITY|||||||0.8974|||||||Log Rank|||||||0.8974
72502224|NCT00914628|144534832|SUPERIORITY|||||||0.7612|||||||Wilcoxon (Mann-Whitney)|||DFS- Intention-To-Treat population- from baseline to day 21||||0.7612
72502225|NCT00914628|144534832|SUPERIORITY|||||||0.5995|||||||Log Rank|||||||0.5995
72502226|NCT00914628|144534832|SUPERIORITY|||||||0.4078|||||||Wilcoxon (Mann-Whitney)|||DFS- Intention-To-Treat population - day 21 after transplant||||0.4078
72502227|NCT00914628|144534832|SUPERIORITY|||||||0.3351|||||||Log Rank|||DFS- Per-Protocol Set||||0.3351
72502228|NCT00914628|144534832|SUPERIORITY|||||||0.1233|||||||Wilcoxon (Mann-Whitney)|||DFS- Per-Protocol Set||||0.1233
72502229|NCT00914628|144534832|EQUIVALENCE|||||||0.5995|||||||Log Rank|||DFS- Per-Protocol Set DFS-day 21 after transplant||||0.5995
72502230|NCT00914628|144534832|SUPERIORITY|||||||0.4078|||||||Wilcoxon (Mann-Whitney)|||DFS- Per-Protocol Set DFS-day 21 after transplant||||0.4078
72463831|NCT02151643|144450433|OTHER||Mean Difference (Final Values)|0.007|STANDARD_ERROR_OF_MEAN|0.2881|||ONE_SIDED|97.5||0.659||||||ITT population supportive analysis - mixed model repeated measures for change in serum phosphate concentration||0.659||
72463832|NCT02151643|144450433|OTHER||Mean Difference (Final Values)|-0.705|STANDARD_ERROR_OF_MEAN|0.2891|||ONE_SIDED|97.5||-0.05||||||ITT population supportive analysis - mixed model repeated measures for change in serum phosphate concentration||-0.05||
72463833|NCT02151643|144450433|OTHER||Mean Difference (Final Values)|-1.195|STANDARD_ERROR_OF_MEAN|0.255|||ONE_SIDED|97.5||-0.618||||||ITT population supportive analysis - mixed model repeated measures for change in serum phosphate concentration||-0.618||
72463834|NCT02151643|144450434|OTHER|||||||0.497|||||||ANCOVA|||Repeated measures ANCOVA for change in haemoglobin concentration from Baseline by PT20 dose group.||||0.497
72463835|NCT02151643|144450434|OTHER||||||<|0.001|||||||ANCOVA|||Repeated measures ANCOVA for change in haemoglobin concentration from Baseline by baseline hemoglobin.||||<0.001
72463836|NCT02151643|144450435|OTHER|||||||0.243|||||||ANCOVA|||Repeated measures ANCOVA for change in serum ferritin concentration from Baseline by PT20 dose group.||||0.243
72463837|NCT02151643|144450435|OTHER|||||||0.867|||||||ANCOVA|||Repeated measures ANCOVA for change in serum ferritin concentration from Baseline by Visit.||||0.867
72463838|NCT02151643|144450435|OTHER|||||||0.186|||||||ANCOVA|||Repeated measures ANCOVA for change in serum ferritin concentration from Baseline by baseline serum ferritin concentration||||0.186
72463839|NCT02151643|144450436|OTHER|||||||0.068|||||||ANCOVA|||Repeated measures ANCOVA for change in transferrin saturation from Baseline by PT20 dose group.||||0.068
72463840|NCT02151643|144450436|OTHER|||||||0.013|||||||ANCOVA|||Repeated measures ANCOVA for change in transferrin saturation from Baseline by Visit.||||0.013
72463841|NCT02151643|144450436|OTHER||||||<|0.001|||||||ANCOVA|||Repeated measures ANCOVA for change in transferrin saturation from Baseline by Baseline Transferrin Saturation.||||<0.001
72502231|NCT00914628|144534833|SUPERIORITY|||||||0.766|||||||Log Rank|Statistical analysis was performed on Intention-To-Treat population.||||||0.7660
72563849|NCT04025684|144659053|SUPERIORITY||Adjusted Mean Change|-0.57|STANDARD_ERROR_OF_MEAN|0.066|<|0.0001|TWO_SIDED|95.0|-0.7|-0.44||Analysis was performed using ANCOVA model with product group as a fixed effect, and the baseline mean TPI overall value and RPI stratification level as covariates.|ANCOVA|||Statistical analysis was performed with comparison in pre-treatment and post-treatment within the treatment group.||-0.44|-0.70|<0.0001
72463842|NCT02151643|144450437|OTHER|||||||0.004|||||||ANCOVA|||Repeated measures ANCOVA for change in Calcium x Phosphate Product from Baseline by PT20 dose group.||||0.004
72463843|NCT02151643|144450437|OTHER||||||<|0.001|||||||ANCOVA|||Repeated measures ANCOVA for change in transferrin saturation from Baseline by Baseline Calcium x Phosphate Product.||||<0.001
72463844|NCT02151643|144450438|OTHER|||||||0.292|||||||paired z-test|||||||0.292
72563850|NCT02070757|144659069|NON_INFERIORITY|Meropenem minus ceftolozane/tazobactam. For ceftolozane/tazobactam to be non-inferior to meropenem the lower bound of a 2-sided 95% confidence interval (CI) for the difference between treatment groups had to be ≥ -10%.|Difference in Percentage of Participants|1.1|||||TWO_SIDED|95.0|-5.13|7.39|||||The % difference between groups is the weighted proportion difference using MRc stratum weights for diagnosis and age categories. The 95% CI was stratified Wilson intervals for group percentages and a stratified Newcombe interval for the difference.|||7.39|-5.13|
72621220|NCT02732145|144773186|EQUIVALENCE|Question: Is there a difference in the incidence of intermittent diarrhea between patients from different groups?||||||0.0192|||||||Chi-squared|||Parameter: The difference in the incidence of intermittent diarrhea between patients from different groups.||||0.0192
72463845|NCT02151643|144450438|OTHER|||||||0.047|||||||paired z-test|||||||0.047
72463846|NCT02151643|144450438|OTHER|||||||0.872|||||||paired z-test|||||||0.872
72463847|NCT02151643|144450438|OTHER|||||||0.288|||||||paired z-test|||||||0.288
72463848|NCT03619889|144450439|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
72463849|NCT03619889|144450439|OTHER||Mean Difference (Net)|-1.2|||<|0.001|TWO_SIDED||||||t-test, 2 sided|||||||<0.001
72463850|NCT03619889|144450446|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
72463851|NCT03619889|144450446|OTHER||Mean Difference (Net)|-0.65|||<|0.001|TWO_SIDED||||||t-test, 2 sided|||||||<0.001
72463852|NCT01084239|144450472|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Fisher Exact|Result for index hospitalization||||||<0.001
72463853|NCT02679079|144450476|SUPERIORITY||Mean Difference (Net)|-0.3|STANDARD_ERROR_OF_MEAN|2.1||0.89|TWO_SIDED|95.0|-4.4|3.8||Nominal p-value is considered statistically significant if less than 0.05. To control for multiplicity, comparisons were tested sequentially.|Mixed Models Analysis|||||3.8|-4.4|0.89
72463854|NCT02679079|144450476|SUPERIORITY||Mean Difference (Net)|1.5|STANDARD_ERROR_OF_MEAN|2.1||0.47|TWO_SIDED|95.0|-2.6|5.6||To control for multiplicity, comparisons were tested sequentially. Nominal p-value was not evaluated for statistical significance since first comparison was not statistically significant.|Mixed Models Analysis|||||5.6|-2.6|0.47
72463855|NCT02679079|144450477|SUPERIORITY||Mean Difference (Net)|-0.4|STANDARD_ERROR_OF_MEAN|0.3||0.21|TWO_SIDED|95.0|-1.0|0.2||To control for multiplicity, comparisons were tested sequentially. Nominal p-value was not evaluated for statistical significance since first comparison was not statistically significant.|Mixed Models Analysis|||||0.2|-1.0|0.21
72463856|NCT02679079|144450477|SUPERIORITY||Mean Difference (Net)|0.1|STANDARD_ERROR_OF_MEAN|0.3||0.67|TWO_SIDED|95.0|-0.5|0.8||To control for multiplicity, comparisons were tested sequentially. Nominal p-value was not evaluated for statistical significance since first comparison was not statistically significant.|Mixed Models Analysis|||||0.8|-0.5|0.67
72463857|NCT02679079|144450478|SUPERIORITY||Risk Difference (RD)|13.9||||0.24|TWO_SIDED|||||Comparison was not included in multiplicity adjustment procedure.|Cochran-Mantel-Haenszel|Stratified by age group (6 to 11 years, 12 to 17 years)|Risk difference expressed as percentage.|||||0.24
72502232|NCT00914628|144534833|SUPERIORITY|||||||0.6706|||||||Wilcoxon (Mann-Whitney)|||Statistical analysis has been performed for Intention-To-Treat population.||||0.6706
72502233|NCT00914628|144534833|SUPERIORITY|||||||0.7332|||||||Log Rank|||Statistical analysis has been performed for Per-Protocol Set)||||0.7332
72502234|NCT00914628|144534833|SUPERIORITY|||||||0.6439|||||||Wilcoxon (Mann-Whitney)|||Statistical analysis has been performed for Per-Protocol Set)||||0.6439
72502235|NCT00914628|144534834|SUPERIORITY|||||||0.1735|||||||Chi-squared|||This Statistical analysis refers to Immune reconstitution and was performed by Gray's Test for Equality of Cumulative Incidence Functions for intention-To-Treat population||||0.1735
72463858|NCT02679079|144450478|SUPERIORITY||Risk Difference (RD)|-4.5||||0.71|TWO_SIDED|||||Comparison was not included in multiplicity adjustment procedure.|Cochran-Mantel-Haenszel|Stratified by age group (6 to 11 years, 12 to 17 years).|Risk difference expressed as a percentage.|||||0.71
72463859|NCT02679079|144450479|SUPERIORITY||Mean Difference (Net)|-1.9|STANDARD_ERROR_OF_MEAN|2.9||0.52|TWO_SIDED|95.0|-7.7|3.9||Comparison was not included in multiplicity adjustment procedure.|Mixed Models Analysis|||||3.9|-7.7|0.52
72463860|NCT02679079|144450479|SUPERIORITY||Mean Difference (Net)|1.4|STANDARD_ERROR_OF_MEAN|2.9||0.64|TWO_SIDED|95.0|-4.5|7.2||Comparison was not included in multiplicity adjustment procedure.|Mixed Models Analysis|||||7.2|-4.5|0.64
72463861|NCT02679079|144450480|SUPERIORITY||Mean Difference (Net)|-2.3|STANDARD_ERROR_OF_MEAN|4.5||0.6|TWO_SIDED|95.0|-11.2|6.5||Comparison was not included in multiplicity adjustment procedure.|Mixed Models Analysis|||||6.5|-11.2|0.60
72463862|NCT02679079|144450480|SUPERIORITY||Mean Difference (Net)|2.8|STANDARD_ERROR_OF_MEAN|4.5||0.54|TWO_SIDED|95.0|-6.1|11.7||Comparison was not included in multiplicity adjustment procedure.|Mixed Models Analysis|||||11.7|-6.1|0.54
72463863|NCT02679079|144450481|SUPERIORITY||Mean Difference (Net)|-0.5|STANDARD_ERROR_OF_MEAN|1.1||0.64|TWO_SIDED|95.0|-2.6|1.6||Comparison was not included in multiplicity adjustment procedure.|ANCOVA|||||1.6|-2.6|0.64
72463864|NCT02679079|144450481|SUPERIORITY||Mean Difference (Net)|-0.3|STANDARD_ERROR_OF_MEAN|1.1||0.77|TWO_SIDED|95.0|-2.5|1.9||Comparison was not included in multiplicity adjustment procedure.|ANCOVA|||||1.9|-2.5|0.77
72463865|NCT02679079|144450482|SUPERIORITY||Mean Difference (Net)|0.9|STANDARD_ERROR_OF_MEAN|1.2||0.45|TWO_SIDED|95.0|-1.4|3.2||Comparison was not included in multiplicity adjustment procedure.|Mixed Models Analysis|||||3.2|-1.4|0.45
72463866|NCT02679079|144450482|SUPERIORITY||Mean Difference (Net)|-0.4|STANDARD_ERROR_OF_MEAN|1.2||0.72|TWO_SIDED|95.0|-2.7|1.9||Comparison was not included in multiplicity adjustment procedure.|Mixed Models Analysis|||||1.9|-2.7|0.72
72463867|NCT02679079|144450483|SUPERIORITY||Mean Difference (Net)|0.2|STANDARD_ERROR_OF_MEAN|0.2||0.41|TWO_SIDED|95.0|-0.3|0.7||Comparison was not included in multiplicity adjustment procedure.|Mixed Models Analysis|||||0.7|-0.3|0.41
72502236|NCT00914628|144534834|SUPERIORITY|||||||0.5958|||||||Chi-squared|||This Statistical analysis refers to deaths without previous immune reconstitution, relapse or progression and was performed by Gray's Test for Equality of Cumulative Incidence Functions for intention-To-Treat population||||0.5958
72502237|NCT00914628|144534834|SUPERIORITY|||||||0.2889|||||||Chi-squared|||This Statistical Analysis refers to patients with relapse or progression without previous immune reconstitution and was performed Gray's Test for Equality of Cumulative Incidence Functions||||0.2889
72463868|NCT02679079|144450483|SUPERIORITY||Mean Difference (Net)|0.6|STANDARD_ERROR_OF_MEAN|0.2||0.01|TWO_SIDED|95.0|0.2|1.1||Comparison was not included in multiplicity adjustment procedure.|Mixed Models Analysis|||||1.1|0.2|0.01
72463869|NCT02679079|144450484|SUPERIORITY||Risk Difference (RD)|14.8||||0.18|TWO_SIDED|||||Comparison was not included in multiplicity adjustment procedure.|Cochran-Mantel-Haenszel|Stratified by age group (6 to 11 years, 12 to 17 years).|Risk difference expressed as a percentage.|||||0.18
72463870|NCT02679079|144450484|SUPERIORITY||Risk Difference (RD)|-0.7||||0.95|TWO_SIDED|||||Comparison was not included in multiplicity adjustment procedure.|Cochran-Mantel-Haenszel|Stratified by age group (6 to 11 years, 12 to 17 years).|Risk difference expressed as a percentage.|||||0.95
72463871|NCT03924947|144450485|NON_INFERIORITY|The pre-specified non-inferiority margin of upper bound of the two-sided 99% confidence interval for the treatment difference was 12%.|Least Squares (LS) Mean of Difference|0.94|STANDARD_ERROR_OF_MEAN|1.176|||TWO_SIDED|99.0|-2.37|4.259|||||LS mean (standard error \[SE\]) and LS mean confidence interval (CI) are based on a mixed effects model including sequence, period and regimen as fixed effects and participants within sequence as a random effect.|Double Blind Creon - Double Blind Creon MP||4.259|-2.370|
72463872|NCT03924947|144450486|OTHER|Descriptive|LS Mean of Difference|-0.03|STANDARD_ERROR_OF_MEAN|1.169|||TWO_SIDED|95.0|-2.456|2.392|||||LS mean (SE) and LS mean CI are based on a mixed effects model including sequence, period and regimen as fixed effects and participants within sequence as a random effect.|Creon - Creon MP||2.392|-2.456|
72463873|NCT03924947|144450486|OTHER|Descriptive|LS Mean of Difference|-0.83|STANDARD_ERROR_OF_MEAN|1.035|||TWO_SIDED|95.0|-3.005|1.345|||||LS mean (SE) and LS mean CI are based on a mixed effects model including sequence, period and regimen as fixed effects and participants within sequence as a random effect.|Creon - Creon AAPIS||1.345|-3.005|
72463874|NCT03924947|144450487|OTHER|Descriptive|LS Mean of Difference|-3.36|STANDARD_ERROR_OF_MEAN|3.541|||TWO_SIDED|95.0|-10.699|3.987|||||LS mean (SE) and LS mean CI are based on a mixed effects model including sequence, period and regimen as fixed effects and participants within sequence as a random effect.|Creon - Creon MP||3.987|-10.699|
72463875|NCT03924947|144450487|OTHER|Descriptive|LS Mean of Difference|3.27|STANDARD_ERROR_OF_MEAN|4.016|||TWO_SIDED|95.0|-5.172|11.702|||||LS mean (SE) and LS mean CI are based on a mixed effects model including sequence, period and regimen as fixed effects and participants within sequence as a random effect.|DB Creon - DB Creon AAPIS||11.702|-5.172|
72463876|NCT03924947|144450488|OTHER|Descriptive|LS Mean of Difference|34.68|STANDARD_ERROR_OF_MEAN|62.253|||TWO_SIDED|95.0|-94.424|163.786|||||LS mean (SE) and LS mean CI are based on a mixed effects model including sequence, period and regimen as fixed effects and participants within sequence as a random effect.|Creon - Creon MP||163.786|-94.424|
72502238|NCT00914628|144534834|SUPERIORITY|||||||0.1642|||||||Chi-squared|||This Statistical analysis refers to Immune reconstitution and was performed by Gray's Test for Equality of Cumulative Incidence Functions for Per-Protocol Set.||||0.1642
72502239|NCT00914628|144534834|SUPERIORITY|||||||0.8739|||||||Log Rank|||This Statistical analysis refers to deaths without previous immune reconstitution, relapse or progression and was performed by Gray's Test for Equality of Cumulative Incidence Functions for intention-To-Treat population||||0.8739
72502240|NCT00914628|144534834|SUPERIORITY|||||||0.2304|||||||Chi-squared|||This Statistical Analysis refers to patients with relapse or progression without previous immune reconstitution and was performed Gray's Test for Equality of Cumulative Incidence Functions||||0.2304
72502241|NCT00914628|144534839|SUPERIORITY|||||||0.3526|||||||Chi-squared|||This Statistical Analysis refers to ITT Patients with relapse or progression and was performed with Gray's Test for Equality of Cumulative Incidence Functions||||0.3526
72621221|NCT02732145|144773186|EQUIVALENCE|Question: Is there a difference in the incidence of frequent diarrhea between patients from different groups?||||||0.5253|||||||Chi-squared|||Parameter: The difference in the incidence of frequent diarrhea between patients from different groups.||||0.5253
72463877|NCT03924947|144450488|OTHER|Descriptive|LS Mean of Difference|-16.56|STANDARD_ERROR_OF_MEAN|60.858|||TWO_SIDED|95.0|-144.418|111.298|||||LS mean (SE) and LS mean CI are based on a mixed effects model including sequence, period and regimen as fixed effects and participants within sequence as a random effect.|DB Creon - DB Creon AAPIS||111.298|-144.418|
72463878|NCT03924947|144450489|NON_INFERIORITY|The pre-specified non-inferiority margin of upper bound of the two-sided 99% confidence interval for the treatment difference was 12%.|LS Mean of Difference|-1.15|STANDARD_ERROR_OF_MEAN|1.302|||TWO_SIDED|99.0|-4.892|2.602|||||LS mean (SE) and LS mean CI are based on a mixed effects model including sequence, period and regimen as fixed effects and participants within sequence as a random effect.|Double Blind Creon - Double Blind Creon AAPIS||2.602|-4.892|
72463879|NCT04150341|144450490|SUPERIORITY||Mean Difference (Final Values)|-0.01||||0.881|TWO_SIDED|95.0|-0.14|0.12|||Mixed Models Analysis|||||0.12|-0.14|0.881
72463880|NCT04150341|144450490|SUPERIORITY||Mean Difference (Final Values)|-0.04||||0.575|TWO_SIDED|95.0|-0.17|0.1|||Mixed Models Analysis|||||0.1|-0.17|0.575
72463881|NCT00843115|144450512|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Binomial test of proportions|Holms multiplicity adjustment (Stepdown Bonferroni) for statistical significance of each p-value, while controlling experiment wise error rate at 0.05||null hypothesis: the proportion of subjects who improved or stabilized, among those who had the symptom at baseline, is less than or equal to 0.5; the alternative hypothesis: this proportion is greater than 0.5.||||<0.0001
72463882|NCT00843115|144450513|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Binomial test of proportions|Holms multiplicity adjustment Stepdown Bonferroni) for statistical significance of each p-value, while controlling experiment wise error rate at 0.05||null hypothesis: the proportion of subjects who improved or stabilized, among those who had the symptom at baseline, is less than or equal to 0.5; the alternative hypothesis: this proportion is greater than 0.5.||||<0.0001
72463883|NCT00843115|144450514|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Binomial test of proportions|Holms multiplicity adjustment (Stepdown Bonferroni) for statistical significance of each p-value, while controlling experiment wise error rate at 0.05||null hypothesis: the proportion of subjects who improved or stabilized, among those who had the symptom at baseline, is less than or equal to 0.5; the alternative hypothesis: this proportion is greater than 0.5||||<0.0001
72621222|NCT02732145|144773186|EQUIVALENCE|Question: Is there a difference in the incidence of the irritable colon between patients from different groups?||||||0.006|||||||Chi-squared|||Parameter: The difference in the incidence of the irritable colon between patients from different groups.||||0.0060
72463884|NCT00843115|144450515|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Binomial test of proportions|Holms multiplicity adjustment (Stepdown Bonferroni) for statistical significance of each p-value, while controlling experiment wise error rate at 0.05||null hypothesis: the proportion of subjects who improved or stabilized, among those who had the symptom at baseline, is less than or equal to 0.5; the alternative hypothesis: this proportion is greater than 0.5||||<0.0001
72463885|NCT00843115|144450516|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Binomial test of proportions|Holms multiplicity adjustment (Stepdown Bonferroni) for statistical significance of each p-value, while controlling experiment wise error rate at 0.05||null hypothesis: the proportion of subjects who improved or stabilized, among those who had the symptom at baseline, is less than or equal to 0.5; the alternative hypothesis: this proportion is greater than 0.5||||<0.0001
72463886|NCT00843115|144450517|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Binomial test of proportions|Holms multiplicity adjustment (Stepdown Bonferroni) for statistical significance of each p-value, while controlling experiment wise error rate at 0.05||null hypothesis: the proportion of subjects who improved or stabilized, among those who had the symptom at baseline, is less than or equal to 0.5; the alternative hypothesis: this proportion is greater than 0.5||||<0.0001
72463887|NCT00843115|144450518|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Binomial test of proportions|Holms multiplicity adjustment (Stepdown Bonferroni) for statistical significance of each p-value, while controlling experiment wise error rate at 0.05||null hypothesis: the proportion of subjects who improved or stabilized, among those who had the symptom at baseline, is less than or equal to 0.5; the alternative hypothesis: this proportion is greater than 0.5||||<0.0001
72463888|NCT00843115|144450519|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Binomial test of proportions|Holms multiplicity adjustment (Stepdown Bonferroni) for statistical significance of each p-value, while controlling experiment wise error rate at 0.05||null hypothesis: the proportion of subjects who improved or stabilized, among those who had the symptom at baseline, is less than or equal to 0.5; the alternative hypothesis: this proportion is greater than 0.5||||<0.0001
72463889|NCT00843115|144450520|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Binomial test of proportions|Holms multiplicity adjustment (Stepdown Bonferroni) for statistical significance of each p-value, while controlling experiment wise error rate at 0.05||null hypothesis: the proportion of subjects who improved or stabilized, among those who had the symptom at baseline, is less than or equal to 0.5; the alternative hypothesis: this proportion is greater than 0.5||||<0.0001
72502242|NCT00914628|144534839|SUPERIORITY|||||||0.4035|||||||Chi-squared|||this Gray's Statistical Analysis refers to ITT Deaths patients without previous relapse or progression and was performed with Test for Equality of Cumulative Incidence Functions||||0.4035
72502243|NCT00914628|144534839|SUPERIORITY|||||||0.2607|||||||Chi-squared|||this Gray's Statistical Analysis refers to PPS patients with relapse or progression and was performed with Test for Equality of Cumulative Incidence Functions||||0.2607
72502244|NCT00914628|144534839|SUPERIORITY|||||||0.5929|||||||Chi-squared|||this Gray's Statistical Analysis refers to PPS Deaths patients without previous relapse or progression and was performed with Test for Equality of Cumulative Incidence Function||||0.5929
72502245|NCT00914628|144534843|SUPERIORITY|||||||0.4035|||||||Chi-squared|||This Statistical Analysis refers to ITT Deaths without previous relapse or progression and was performed with Gray's Test for Equality of Cumulative Incidence Functions||||0.4035
72502246|NCT00914628|144534843|SUPERIORITY|||||||0.3526|||||||Chi-squared|||This statistical test refers to Patients with relapse or progression and was performed to Gray's Test for Equality of Cumulative Incidence Functions.||||0.3526
72563851|NCT02070757|144659070|NON_INFERIORITY|Clinical Response difference is calculated as ceftolozane/tazobactam minus meropenem. For ceftolozane/tazobactam to be non-inferior to meropenem the lower bound of a 2-sided 95% confidence interval (CI) for the difference between treatment groups had to be ≥ -12.5%.|Difference in percentage of participants|1.1|||||TWO_SIDED|95.0|-6.17|8.29|||||The % difference between groups is the weighted proportion difference using MRc stratum weights for diagnosis and age categories. The 95% CI was stratified Wilson intervals for group percentages and a stratified Newcombe interval for the difference.|||8.29|-6.17|
72563852|NCT02070757|144659071|OTHER|The % difference is the weighted proportion difference using Mehrotra-Railkar continuity-corrected-minimum risk (MRc) stratum weights for strata of diagnosis (VABP, ventilated HABP) and age (\<65, \>=65) categories.|Difference in Percentage of Participants|4.4|||||TWO_SIDED|95.0|-2.83|11.75|||||The 95% confidence interval (CI) were stratified Wilson intervals for the treatment group percentages and a stratified Newcombe interval for the treatment difference, constructed using the MRc stratum weights.|Difference in Percentage of Participants||11.75|-2.83|
72563853|NCT02070757|144659072|OTHER|The % difference is the weighted proportion difference using Mehrotra-Railkar continuity-corrected-minimum risk (MRc) stratum weights for strata of diagnosis (VABP, ventilated HABP) and age (\<65, \>=65) categories.|Difference in Percentage of Participants|-1.3|||||TWO_SIDED|95.0|-10.21|7.67|||||The 95% confidence interval (CI) were stratified Wilson intervals for the treatment group percentages and a stratified Newcombe interval for the treatment difference, constructed using the MRc stratum weights.|Difference in Percentage of Participants||7.67|-10.21|
72563854|NCT02070757|144659073|OTHER|The % difference is the weighted proportion difference using Mehrotra-Railkar continuity-corrected-minimum risk (MRc) stratum weights for strata of diagnosis (VABP, ventilated HABP) and age (\<65, \>=65) categories.|Difference in Percentage of Participants|7.0||||||95.0|-5.11|18.93|||||The 95% confidence interval (CI) were stratified Wilson intervals for the treatment group percentages and a stratified Newcombe interval for the treatment difference, constructed using the MRc stratum weights.|Difference in Percentage of Participants||18.93|-5.11|
72563855|NCT02070757|144659075|OTHER|The % difference is the weighted proportion difference using Mehrotra-Railkar continuity-corrected-minimum risk (MRc) stratum weights for strata of diagnosis (VABP, ventilated HABP) and age (\<65, \>=65) categories.|Difference in Percentage of Participants|-1.4|||||TWO_SIDED|95.0|-6.41|3.57|||||The 95% confidence interval (CI) were stratified Wilson intervals for the treatment group percentages and a stratified Newcombe interval for the treatment difference, constructed using the MRc stratum weights.|Difference in Percentage of Participants||3.57|-6.41|
72563856|NCT02070757|144659076|OTHER|The % difference is the weighted proportion difference using Mehrotra-Railkar continuity-corrected-minimum risk (MRc) stratum weights for strata of diagnosis (VABP, ventilated HABP) and age (\<65, \>=65) categories.|Difference in Percentage of Participants|-0.8|||||TWO_SIDED|95.0|-7.67|6.04|||||The 95% confidence interval (CI) were stratified Wilson intervals for the treatment group percentages and a stratified Newcombe interval for the treatment difference, constructed using the MRc stratum weights.|Difference in Percentage of Participants||6.04|-7.67|
72563857|NCT02070757|144659077|OTHER|The % difference is the weighted proportion difference using Mehrotra-Railkar continuity-corrected-minimum risk (MRc) stratum weights for strata of diagnosis (VABP, ventilated HABP) and age (\<65, \>=65) categories.|Difference in Percentage of Participants|1.6|||||TWO_SIDED|95.0|-8.91|12.02|||||The 95% confidence interval (CI) were stratified Wilson intervals for the treatment group percentages and a stratified Newcombe interval for the treatment difference, constructed using the MRc stratum weights.|Difference in Percentage of Participants||12.02|-8.91|
72563858|NCT02070757|144659078|OTHER|The % difference is the weighted proportion difference using Mehrotra-Railkar continuity-corrected-minimum risk (MRc) stratum weights for strata of diagnosis (VABP, ventilated HABP) and age (\<65, \>=65) categories.|Difference in Percentage of Participants|3.3|||||TWO_SIDED|95.0|-3.38|10.44|||||The 95% confidence interval (CI) were stratified Wilson intervals for the treatment group percentages and a stratified Newcombe interval for the treatment difference, constructed using the MRc stratum weights.|Difference in Percentage of Participants||10.44|-3.38|
72563859|NCT01546922|144659082|SUPERIORITY_OR_OTHER|||||||0.861||||||A Bonferroni correction for multiple comparisons was applied, resulting in a significance level of 0.001.|Wilcoxon (Mann-Whitney)|||Rivermead Behavioural Memory Test (RBMT) - Immediate memory||||0.861
72563860|NCT01546922|144659082|SUPERIORITY_OR_OTHER|||||||0.668||||||A Bonferroni correction for multiple comparisons was applied, resulting in a significance level of 0.001.|Wilcoxon (Mann-Whitney)|||RBMT - Delayed memory||||0.668
72563861|NCT01546922|144659082|SUPERIORITY_OR_OTHER|||||||0.713||||||A Bonferroni correction for multiple comparisons was applied, resulting in a significance level of 0.001.|Wilcoxon (Mann-Whitney)|||RBMT-Delayed corrected for immediate memory||||0.713
72563862|NCT01546922|144659082|SUPERIORITY_OR_OTHER|||||||0.028||||||A Bonferroni correction for multiple comparisons was applied, resulting in a significance level of 0.001.|Wilcoxon (Mann-Whitney)|||15 Words Test - Short-term memory||||0.028
72563863|NCT01546922|144659082|SUPERIORITY_OR_OTHER|||||||0.227||||||A Bonferroni correction for multiple comparisons was applied, resulting in a significance level of 0.001.|Wilcoxon (Mann-Whitney)|||15 Words Test - Total immediate memory||||0.227
72563864|NCT01546922|144659082|SUPERIORITY_OR_OTHER|||||||0.13||||||A Bonferroni correction for multiple comparisons was applied, resulting in a significance level of 0.001.|Wilcoxon (Mann-Whitney)|||15 Words Test - Learning Score||||0.130
72563865|NCT01546922|144659082|SUPERIORITY_OR_OTHER|||||||0.106||||||A Bonferroni correction for multiple comparisons was applied, resulting in a significance level of 0.001.|Wilcoxon (Mann-Whitney)|||15 Words Test- Delayed memory||||0.106
72563866|NCT01546922|144659082|SUPERIORITY_OR_OTHER|||||||0.35||||||A Bonferroni correction for multiple comparisons was applied, resulting in a significance level of 0.001.|Wilcoxon (Mann-Whitney)|||15 Words Test - Delayed corrected for total memory||||0.350
72563867|NCT01546922|144659082|SUPERIORITY_OR_OTHER|||||||0.093||||||A Bonferroni correction for multiple comparisons was applied, resulting in a significance level of 0.001.|Wilcoxon (Mann-Whitney)|||15 Words Test - Recognition||||0.093
72563868|NCT01546922|144659082|SUPERIORITY_OR_OTHER|||||||0.614||||||A Bonferroni correction for multiple comparisons was applied, resulting in a significance level of 0.001.|Wilcoxon (Mann-Whitney)|||Digit Span forward - Short-term memory||||0.614
72463890|NCT00843115|144450521|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Binomial test of proportions|Holms multiplicity adjustment (Stepdown Bonferroni) for statistical significance of each p-value, while controlling experiment wise error rate at 0.05||null hypothesis: the proportion of subjects who improved or stabilized, among those who had the symptom at baseline, is less than or equal to 0.5; the alternative hypothesis: this proportion is greater than 0.5||||<0.0001
72463891|NCT00843115|144450522|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Binomial test of proportions|Holms multiplicity adjustment (Stepdown Bonferroni) for statistical significance of each p-value, while controlling experiment wise error rate at 0.05||null hypothesis: the proportion of subjects who improved or stabilized, among those who had the symptom at baseline, is less than or equal to 0.5; the alternative hypothesis: this proportion is greater than 0.5||||<0.0001
72463892|NCT00843115|144450523|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Binomial test of proportions|Holms multiplicity adjustment (Stepdown Bonferroni) for statistical significance of each p-value, while controlling experiment wise error rate at 0.05||null hypothesis: the proportion of subjects who improved or stabilized, among those who had the symptom at baseline, is less than or equal to 0.5; the alternative hypothesis: this proportion is greater than 0.5||||<0.0001
72463893|NCT00843115|144450524|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Binomial test of proportions|Holms multiplicity adjustment (Stepdown Bonferroni) for statistical significance of each p-value, while controlling experiment wise error rate at 0.05||null hypothesis: the proportion of subjects who improved or stabilized, among those who had the symptom at baseline, is less than or equal to 0.5; the alternative hypothesis: this proportion is greater than 0.5||||<0.0001
72463894|NCT00843115|144450525|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Binomial test of proportions|Holms multiplicity adjustment (Stepdown Bonferroni) for statistical significance of each p-value, while controlling experiment wise error rate at 0.05||null hypothesis: the proportion of subjects who improved or stabilized, among those who had the symptom at baseline, is less than or equal to 0.5; the alternative hypothesis: this proportion is greater than 0.5||||<0.0001
72463895|NCT00843115|144450526|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Binomial test of proportions|Holms multiplicity adjustment (Stepdown Bonferroni) for statistical significance of each p-value, while controlling experiment wise error rate at 0.05||null hypothesis: the proportion of subjects who improved or stabilized, among those who had the symptom at baseline, is less than or equal to 0.5; the alternative hypothesis: this proportion is greater than 0.5||||<0.0001
72463896|NCT00843115|144450527|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Binomial test of proportions|Holms multiplicity adjustment (Stepdown Bonferroni) for statistical significance of each p-value, while controlling experiment wise error rate at 0.05||null hypothesis: the proportion of subjects who improved or stabilized, among those who had the symptom at baseline, is less than or equal to 0.5; the alternative hypothesis: this proportion is greater than 0.5||||<0.0001
72463897|NCT00843115|144450528|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Binomial test of proportions|Holms multiplicity adjustment (Stepdown Bonferroni) for statistical significance of each p-value, while controlling experiment wise error rate at 0.05||null hypothesis: the proportion of subjects who improved or stabilized, among those who had the symptom at baseline, is less than or equal to 0.5; the alternative hypothesis: this proportion is greater than 0.5||||<0.0001
72463898|NCT00843115|144450529|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Binomial test of proportions|Holms multiplicity adjustment (Stepdown Bonferroni) for statistical significance of each p-value, while controlling experiment wise error rate at 0.05||null hypothesis: the proportion of subjects who improved or stabilized, among those who had the symptom at baseline, is less than or equal to 0.5; the alternative hypothesis: this proportion is greater than 0.5||||<0.0001
72502247|NCT00914628|144534843|SUPERIORITY|||||||0.5929|||||||Chi-squared|||This Statistical Analysis refers to PPS Deaths without previous relapse or progression and was performed with Gray's Test for Equality of Cumulative Incidence Functions||||0.5929
72563869|NCT01546922|144659082|SUPERIORITY_OR_OTHER|||||||0.111||||||A Bonferroni correction for multiple comparisons was applied, resulting in a significance level of 0.001.|Wilcoxon (Mann-Whitney)|||Rey Complex Figure - Immediate memory||||0.111
72463899|NCT00843115|144450530|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Binomial test of proportions|Holms multiplicity adjustment (Stepdown Bonferroni) for statistical significance of each p-value, while controlling experiment wise error rate @ 0.05||null hypothesis: the proportion of subjects who improved or stabilized, among those who had the symptom at baseline, is less than or equal to 0.5; the alternative hypothesis: this proportion is greater than 0.5||||<0.0001
72463900|NCT00843115|144450531|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Binomial test of proportions|Holms multiplicity adjustment (Stepdown Bonferroni) for statistical significance of each p-value, while controlling experiment wise error rate at 0.05||null hypothesis: the proportion of subjects who improved or stabilized, among those who had the symptom at baseline, is less than or equal to 0.5; the alternative hypothesis: this proportion is greater than 0.5||||<0.0001
72463901|NCT00843115|144450532|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Binomial test of proportions|Holms multiplicity adjustment (Stepdown Bonferroni) for statistical significance of each p-value, while controlling experiment wise error rate at 0.05||null hypothesis: the proportion of subjects who improved or stabilized, among those who had the symptom at baseline, is less than or equal to 0.5; the alternative hypothesis: this proportion is greater than 0.5||||<0.0001
72502248|NCT00914628|144534843|SUPERIORITY|||||||0.2607|||||||Chi-squared|||This statistical test refers to Patients with relapse or progression and was performed to Gray's Test for Equality of Cumulative Incidence Functions.||||0.2607
72502249|NCT00469079|144534857|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002|TWO_SIDED|95.0|||||Mixed Models Analysis|||||||0.002
72502250|NCT00469079|144534858|SUPERIORITY_OR_OTHER_LEGACY|||||||0.05|||||||Mixed Models Analysis|||Product use is by self-report and daily diaries.||||0.05
72563870|NCT01546922|144659082|SUPERIORITY_OR_OTHER|||||||0.451||||||A Bonferroni correction for multiple comparisons was applied, resulting in a significance level of 0.001.|Wilcoxon (Mann-Whitney)|||Rey Complex Figure - Delayed memory||||0.451
72563871|NCT01546922|144659082|SUPERIORITY_OR_OTHER|||||||0.905||||||A Bonferroni correction for multiple comparisons was applied, resulting in a significance level of 0.001.|Wilcoxon (Mann-Whitney)|||Divided attention-Reaction time auditory response||||0.905
72463902|NCT00843115|144450533|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|One sample t-test, testing whether mean change from baseline is significantly different from zero.||Change from baseline in total score at Week 12||||<0.0001
72463903|NCT00843115|144450534|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|One sample t-test, testing whether mean change from baseline is significantly different from zero||Change from baseline in total score at Week 12 Last Observation Carried Forward||||<0.0001
72463904|NCT00843115|144450535|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||correlation coefficient|P value tests whether Pearson Product Correlation Coefficient is significantly different from zero||||||<0.0001
72463905|NCT00843115|144450536|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||correlation coefficient|p-value tests whether Pearson Product Correlation Coefficient is significantly different from zero||||||<0.0001
72463906|NCT00843115|144450537|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|One sample t-test, testing whether mean change from baseline is significantly different from zero.||||||<0.0001
72463907|NCT00843115|144450538|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|One sample t-test, testing whether mean change from baseline is significantly different from zero||||||<0.0001
72463908|NCT00843115|144450539|SUPERIORITY_OR_OTHER|||||||0.0713|||||||correlation coefficient|||||||0.0713
72502251|NCT00469079|144534859|SUPERIORITY_OR_OTHER_LEGACY||Other|0.0|||<|0.05|TWO_SIDED|95.0|||||Mixed Models Analysis|A generalized linear mixed model was used for outcomes that had been repeatedly measured from baseline through the end of the treatment period.||This study was not powered to detect differences in smoking cessation rates between groups; however, smoking status was collected to obtain preliminary data. Point prevalence (no smoking during the previous 7 days) cigarette abstinence rates were calculated at the week-4 visit and at each of the 2 follow-up visits. Continuous abstinence rates were calculated for the 4 week period between the week 1 and week 4 visits. Abstinence at all visits was assessed by self-report and confirmed by CO.||||<0.05
72563872|NCT01546922|144659082|SUPERIORITY_OR_OTHER|||||||0.502||||||A Bonferroni correction for multiple comparisons was applied, resulting in a significance level of 0.001.|Wilcoxon (Mann-Whitney)|||Divided attention-Reaction time visual response||||0.502
72563873|NCT01546922|144659082|SUPERIORITY_OR_OTHER|||||||0.531||||||A Bonferroni correction for multiple comparisons was applied, resulting in a significance level of 0.001.|Wilcoxon (Mann-Whitney)|||Divided attention-Number of omission errors||||0.531
72502252|NCT00469079|144534860|SUPERIORITY_OR_OTHER_LEGACY||Mean difference between 3 groups|0.0|||>|0.1|TWO_SIDED|95.0|||||Mixed Models Analysis|||A generalized linear mixed model was used for outcomes that had been repeatedly measured from baseline through the end of the treatment period. Each repeated-measures model included the treatment effect, a visit effect, the interaction between treatment and visit, the interaction between subject error and within-subject error terms.||||> 0.10
72393937|NCT01059825|144294278|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.66||||0|TWO_SIDED|80.0|-0.83|-0.49||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p \<0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-0.49|-0.83|0.000
72463909|NCT00843115|144450540|SUPERIORITY_OR_OTHER|||||||0.0225|||||||Correlation coefficient|||||||0.0225
72463910|NCT00843115|144450541|SUPERIORITY_OR_OTHER|||||||0.0152|||||||t-test, 2 sided|One sample t-test, testing whether mean change from baseline is significantly different from zero.||||||0.0152
72463911|NCT00843115|144450542|SUPERIORITY_OR_OTHER|||||||0.0229|||||||t-test, 2 sided|One sample t-test, testing whether mean change from baseline is significantly different from zero||||||0.0229
72463912|NCT00843115|144450543|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|One sample t-test, testing whether mean change from baseline is significantly different from zero.||||||<0.0001
72463913|NCT00843115|144450544|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|One sample t-test, testing whether mean change from baseline is significantly different from zero.||||||<0.0001
72463914|NCT00843115|144450545|SUPERIORITY_OR_OTHER|||||||0.7963|||||||McNemar|"McNemar's Test for paired proportions tested the difference between the proportion of subjects with Any problem at baseline versus Week 12."||||||0.7963
72463915|NCT00843115|144450546|SUPERIORITY_OR_OTHER|||||||1|||||||McNemar|"McNemar's Test for paired proportions tested the difference between the proportion of subjects with Any problem at baseline versus Week 12 LOCF."||||||1.0000
72463916|NCT00843115|144450547|SUPERIORITY_OR_OTHER|||||||0.0719|||||||McNemar|"McNemar's Test for paired proportions tested the difference between the proportion of subjects with Any problem at baseline versus Week 12"||||||0.0719
72463917|NCT00843115|144450548|SUPERIORITY_OR_OTHER|||||||0.1779|||||||McNemar|"McNemar's Test for paired proportions tested the difference between the proportion of subjects with Any problem at baseline versus Week 12 LOCF."||||||0.1779
72463918|NCT00843115|144450549|SUPERIORITY_OR_OTHER|||||||1|||||||McNemar|"McNemar's Test for paired proportions tested the difference between the proportion of subjects with Any problem at baseline versus Week 12"||||||1.0000
72463919|NCT00843115|144450550|SUPERIORITY_OR_OTHER|||||||0.8575|||||||McNemar|"McNemar's Test for paired proportions tested the difference between the proportion of subjects with Any problem at baseline versus Week 12 LOCF"||||||0.8575
72563874|NCT01546922|144659082|SUPERIORITY_OR_OTHER|||||||0.681||||||A Bonferroni correction for multiple comparisons was applied, resulting in a significance level of 0.001.|Wilcoxon (Mann-Whitney)|||Divided attention-Number of commission errors||||0.681
72563875|NCT01546922|144659082|SUPERIORITY_OR_OTHER|||||||0.713||||||A Bonferroni correction for multiple comparisons was applied, resulting in a significance level of 0.001.|Wilcoxon (Mann-Whitney)|||Visual scanning - Reaction time for target stimuli||||0.713
72463920|NCT00843115|144450551|SUPERIORITY_OR_OTHER|||||||1|||||||McNemar|"McNemar's Test for paired proportions tested the difference between the proportion of subjects with Any problem at baseline versus Week 12"||||||1.0000
72463921|NCT00843115|144450552|SUPERIORITY_OR_OTHER|||||||1|||||||McNemar|"McNemar's Test for paired proportions tested the difference between the proportion of subjects with Any problem at baseline versus Week 12 LOCF"||||||1.0000
72502253|NCT01756157|144534873|SUPERIORITY_OR_OTHER_LEGACY||Mean difference|-0.61||||0.0523|TWO_SIDED|95.0|-1.23|0.01|||Paired t-test, 2 sided|||||0.01|-1.23|0.0523
72502254|NCT02698410|144534881|OTHER|||||||0.2968||||||One-sided p-value estimated using an exact binomial proportion test for one-way tables comparing DCR to 30%.|Binomial proportion test|||Comparison of DCR to 30% clinically relevant threshold.||||0.2968
72621223|NCT02732145|144773187|EQUIVALENCE|Question: Is there a difference in the incidence of any associated symptom or disease among patients from different groups?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of any associated symptom or disease among patients from different groups.||||0.0000
72621224|NCT02732145|144773187|EQUIVALENCE|Question: Is there a difference in the incidence of a frequent headache among patients from different groups?||||||0.3957|||||||Chi-squared|||Parameter: The difference in the incidence of a frequent headache among patients from different groups.||||0.3957
72621225|NCT02732145|144773187|EQUIVALENCE|Question: Is there a difference in the incidence of chronic fatigue among patients from different groups?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of chronic fatigue among patients from different groups.||||0.0000
72463922|NCT00843115|144450553|SUPERIORITY_OR_OTHER|||||||0.0131|||||||McNemar|"McNemar's Test for paired proportions tested the difference between the proportion of subjects with Any problem at baseline versus Week 12"||||||0.0131
72621226|NCT02732145|144773187|EQUIVALENCE|Question: Is there a difference in the incidence of lumbar pain among patients from different groups?||||||0.0001|||||||Chi-squared|||Parameter: The difference in the incidence of lumbar pain among patients from different groups.||||0.0001
72463923|NCT00843115|144450554|SUPERIORITY_OR_OTHER|||||||0.0078|||||||McNemar|"McNemar's Test for paired proportions tested the difference between the proportion of subjects with Any problem at baseline versus Week 12 LOCF"||||||0.0078
72463924|NCT02621047|144450555|SUPERIORITY_OR_OTHER||Geometric Mean Ratio Percentage (%)|128.0|||||TWO_SIDED|90.0|86.5|188.0||||||||188|86.5|
72463925|NCT02621047|144450555|SUPERIORITY_OR_OTHER||Geometric Mean Ratio %|100.0|||||TWO_SIDED|90.0|55.1|183.0||||||||183|55.1|
72463926|NCT02621047|144450556|SUPERIORITY_OR_OTHER||Geometric Mean Ratio %|148.0|||||TWO_SIDED|90.0|106.0|208.0||||||||208|106|
72463927|NCT02621047|144450556|SUPERIORITY_OR_OTHER||Geometric Mean Ratio %|130.0|||||TWO_SIDED|90.0|75.4|225.0||||||||225|75.4|
72502255|NCT02698410|144534881|OTHER||||||<|0.0001||||||One-sided p-value estimated using an exact binomial proportion test for one-way tables comparing DCR to 10%.|Binomial proportion test|||Comparison of DCR to 10% clinically relevant threshold.||||<0.0001
72463928|NCT02621047|144450557|SUPERIORITY_OR_OTHER||Geometric Mean Ratio %|160.0||||||90.0|105.0|243.0||||||||243|105|
72463929|NCT02621047|144450557|SUPERIORITY_OR_OTHER||Geometric Mean Ratio %|220.0||||||90.0|131.0|369.0||||||||369|131|
72463930|NCT02621047|144450558|SUPERIORITY_OR_OTHER||Geometric Mean Ratio %|186.0||||||90.0|122.0|281.0||||||||281|122|
72463931|NCT02621047|144450558|SUPERIORITY_OR_OTHER||Geometric Mean Ratio %|285.0||||||90.0|175.0|466.0||||||||466|175|
72463932|NCT02621047|144450559|SUPERIORITY_OR_OTHER||Geometric Mean Ratio %|162.0|||||TWO_SIDED|90.0|104.0|254.0||||||||254|104|
72463933|NCT02621047|144450559|SUPERIORITY_OR_OTHER||Geometric Mean Ratio %|228.0||||||90.0|129.0|403.0||||||||403|129|
72463934|NCT02621047|144450560|SUPERIORITY_OR_OTHER||Geometric Mean Ratio %|189.0||||||90.0|121.0|293.0||||||||293|121|
72463935|NCT02621047|144450560|SUPERIORITY_OR_OTHER||Geometric Mean Ratio %|296.0|||||TWO_SIDED|90.0|174.0|506.0||||||||506|174|
72463936|NCT02621047|144450561|SUPERIORITY_OR_OTHER||Geometric Mean Ratio %|64.6||||||90.0|36.2|115.0||||||||115|36.2|
72463937|NCT02621047|144450561|SUPERIORITY_OR_OTHER||Geometric Mean Ratio %|60.8|||||TWO_SIDED|90.0|26.6|139.0||||||||139|26.6|
72463938|NCT02621047|144450562|SUPERIORITY_OR_OTHER||Geometric Mean Ratio %|85.1||||||90.0|55.5|130.0||||||||130|55.5|
72463939|NCT02621047|144450562|SUPERIORITY_OR_OTHER||Geometric Mean Ratio %|59.0||||||90.0|34.2|102.0||||||||102|34.2|
72463940|NCT02621047|144450563|SUPERIORITY_OR_OTHER||Geometric Mean Ratio %|116.0||||||90.0|78.6|172.0||||||||172|78.6|
72463941|NCT02621047|144450563|SUPERIORITY_OR_OTHER||Geometric Mean Ratio %|98.1||||||90.0|51.7|186.0||||||||186|51.7|
72463942|NCT02621047|144450564|SUPERIORITY_OR_OTHER||Geometric Mean Ratio %|115.0|||||TWO_SIDED|90.0|85.2|154.0||||||||154|85.2|
72463943|NCT02621047|144450564|SUPERIORITY_OR_OTHER||Geometric Mean Ratio %|96.6|||||TWO_SIDED|90.0|55.6|168.0||||||||168|55.6|
72463944|NCT02621047|144450565|SUPERIORITY_OR_OTHER||Geometric Mean Ratio %|80.6||||||90.0|50.2|130.0||||||||130|50.2|
72463945|NCT02621047|144450565|SUPERIORITY_OR_OTHER||Geometric Mean Ratio %|65.6|||||TWO_SIDED|90.0|26.9|160.0||||||||160|26.9|
72463946|NCT02621047|144450566|SUPERIORITY_OR_OTHER||Geometric Mean Ratio %|104.0||||||90.0|76.8|141.0||||||||141|76.8|
72463947|NCT02621047|144450566|SUPERIORITY_OR_OTHER||Geometric Mean Ratio %|63.7|||||TWO_SIDED|90.0|34.0|119.0||||||||119|34.0|
72463948|NCT02621047|144450567|SUPERIORITY_OR_OTHER||Geometric Mean Ratio %|136.0|||||TWO_SIDED|90.0|94.7|196.0||||||||196|94.7|
72463949|NCT02621047|144450567|SUPERIORITY_OR_OTHER||Geometric Mean Ratio %|176.0||||||90.0|98.4|315.0||||||||315|98.4|
72502256|NCT02698410|144534881|OTHER|||||||0.0534||||||One-sided p-value estimated using an exact binomial proportion test for one-way tables comparing DCR to 30%.|Binomial proportion test|||Sensitivity Analyisis-1: Comparison of DCR to 30% clinically relevant threshold.||||0.0534
72502257|NCT02698410|144534881|OTHER||||||<|0.0001||||||One-sided p-value estimated using an exact binomial proportion test for one-way tables comparing DCR to 10%.|Binomial proportion test|||Sensitivity Analyisis-1: Comparison of DCR to 10% clinically relevant threshold.||||<0.0001
72621227|NCT02732145|144773187|EQUIVALENCE|Question: Is there a difference in the incidence of fibromyalgia among patients from different groups?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of fibromyalgia among patients from different groups.||||0.0000
72621228|NCT02732145|144773187|EQUIVALENCE|Question: Is there a difference in the incidence of energy loss among patients from different groups?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of energy loss among patients from different groups.||||0.0000
72621229|NCT02732145|144773187|EQUIVALENCE|Question: Is there a difference in the incidence of sleep disorders among patients from different groups?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of sleep disorders among patients from different groups.||||0.0000
72621230|NCT02732145|144773187|EQUIVALENCE|Question: Is there a difference in the incidence of pelvic pain among patients from different groups?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of pelvic pain among patients from different groups.||||0.0000
72463950|NCT02621047|144450568|SUPERIORITY_OR_OTHER||Geometric Mean Ratio %|134.0||||||90.0|99.6|181.0||||||||181|99.6|
72463951|NCT02621047|144450568|SUPERIORITY_OR_OTHER||Geometric Mean Ratio %|157.0|||||TWO_SIDED|90.0|91.8|268.0||||||||268|91.8|
72463952|NCT02621047|144450569|SUPERIORITY_OR_OTHER||Geometric Mean Ratio %|73.3|||||TWO_SIDED|90.0|46.2|116.0||||||||116|46.2|
72463953|NCT02621047|144450569|SUPERIORITY_OR_OTHER||Geometric Mean Ratio %|57.5|||||TWO_SIDED|90.0|20.0|165.0||||||||165|20.0|
72463954|NCT02621047|144450570|SUPERIORITY_OR_OTHER||Geometric Mean Ratio %|96.6||||||90.0|69.9|134.0||||||||134|69.9|
72463955|NCT02621047|144450570|SUPERIORITY_OR_OTHER||Geometric Mean Ratio %|55.8||||||90.0|26.0|120.0||||||||120|26.0|
72463956|NCT02621047|144450571|SUPERIORITY_OR_OTHER||Geometric Mean Ratio %|139.0|||||TWO_SIDED|90.0|94.8|203.0||||||||203|94.8|
72463957|NCT02621047|144450571|SUPERIORITY_OR_OTHER||Geometric Mean Ratio %|180.0||||||90.0|97.2|334.0||||||||334|97.2|
72463958|NCT02621047|144450572|SUPERIORITY_OR_OTHER||Geometric Mean Ratio %|137.0|||||TWO_SIDED|90.0|100.0|186.0||||||||186|100|
72463959|NCT02621047|144450572|SUPERIORITY_OR_OTHER||Geometric Mean Ratio %|158.0|||||TWO_SIDED|90.0|91.2|274.0||||||||274|91.2|
72502258|NCT02698410|144534881|OTHER|||||||0.032||||||One-sided p-value estimated using an exact binomial proportion test for one-way tables comparing DCR to 30%.|Binomial proportion test|||Sensitivity Analyisis-2: Comparison of DCR to 30% clinically relevant threshold.||||0.032
72463960|NCT02853305|144450645|SUPERIORITY||Hazard Ratio (HR)|0.78||||0.0033|TWO_SIDED|95.0|0.65|0.93|||Stratified Log-Rank|The treatment difference in PFS was assessed by the stratified log-rank test.||PFS in all participants of the pembro combo arm was compared to PFS in all participants of the chemo arm to address the first primary hypothesis (superiority to chemo). The hazard ratio (HR) and its 95% confidence interval (CI) were estimated using a stratified Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by investigator's choice of chemotherapy (cisplatin or carboplatin) and PD-L1 status (CPS\<10 vs. CPS≥10) at baseline.||0.93|0.65|0.0033
72463961|NCT02853305|144450646|SUPERIORITY||Hazard Ratio (HR)|0.86||||0.0407|TWO_SIDED|95.0|0.72|1.02|||Stratified Log-Rank|The treatment difference in OS was assessed by the stratified log-rank test.||OS in all participants of the pembro combo arm was compared to OS in all participants of the chemo arm to address the second primary hypothesis (superiority to chemo). The HR and its 95% CI were estimated using a stratified Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by investigator's choice of chemotherapy (cisplatin or carboplatin) and PD-L1 status (CPS\<10 vs. CPS≥10) at baseline.||1.02|0.72|0.0407
72463962|NCT02853305|144450647|OTHER||Hazard Ratio (HR)|1.01|||||TWO_SIDED|95.0|0.77|1.32||No formal hypothesis testing was performed.||||OS in CPS≥10 participants of the pembro arm was compared to OS in CPS≥10 participants of the chemo arm. The comparison was based on a Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by investigator's choice of chemotherapy (cisplatin or carboplatin) at baseline.||1.32|0.77|
72463963|NCT02853305|144450648|OTHER||Hazard Ratio (HR)|0.92|||||TWO_SIDED|95.0|0.77|1.11||No formal hypothesis testing was performed.||||OS in all participants of the pembro arm was compared to OS in all participants of the chemo arm. The comparison was based on a Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by investigator's choice of chemotherapy (cisplatin or carboplatin) and PD-L1 status (CPS\<10 vs. CPS≥10) at baseline.||1.11|0.77|
72463964|NCT02853305|144450649|OTHER||Hazard Ratio (HR)|1.32|||||TWO_SIDED|95.0|1.09|1.58||No formal hypothesis testing was performed.||||PFS in all participants of the pembro arm was compared to PFS in all participants of the chemo arm. The comparison was based on a Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by investigator's choice of chemotherapy (cisplatin or carboplatin) and PD-L1 status (CPS\<10 vs. CPS≥10) at baseline.||1.58|1.09|
72463965|NCT02853305|144450652|OTHER||Difference in Percentage|9.8|||||TWO_SIDED|95.0|2.4|17.1||No formal hypothesis testing was performed.||||ORR in participants of the pembro combo arm was compared to ORR in participants of the chemo arm. The comparison was based on the Miettinen \& Nurminen method stratified by investigator's choice of chemotherapy (cisplatin or carboplatin) and PD-L1 status (CPS\<10 vs. CPS≥10) at baseline.||17.1|2.4|
72463966|NCT02853305|144450654|OTHER||Difference in Percentage|4.5|||||TWO_SIDED|95.0|-1.6|10.6||No formal hypothesis testing was performed.||||DCR in participants of the pembro combo arm was compared to DCR in participants of the chemo arm based on the Miettinen \& Nurminen method stratified by investigator's choice of chemotherapy (cisplatin or carboplatin) and PD-L1 status (CPS\<10 vs. CPS≥10) at baseline.||10.6|-1.6|
72463967|NCT02853305|144450655|SUPERIORITY||Difference in Percentage|-14.8|||||TWO_SIDED|95.0|-22.0|-7.4||No formal hypothesis testing was performed.||||ORR in participants of the pembro arm was compared to ORR in participants of the chemo arm. The comparison was based on the Miettinen \& Nurminen method stratified by investigator's choice of chemotherapy (cisplatin or carboplatin) and PD-L1 status (CPS\<10 vs. CPS≥10) at baseline.||-7.4|-22.0|
72463968|NCT02853305|144450657|OTHER||Difference in Percentage|-28.9|||||TWO_SIDED|95.0|-35.9|-21.6||No formal hypothesis testing was performed.||||DCR in participants of the pembro arm was compared to DCR in participants of the chemo arm based on the Miettinen \& Nurminen method stratified by investigator's choice of chemotherapy (cisplatin or carboplatin) and PD-L1 status (CPS\<10 vs. CPS≥10) at baseline.||-21.6|-35.9|
72463969|NCT02853305|144450661|OTHER||Difference in LS Means|2.68|||||TWO_SIDED|95.0|-0.76|6.12||No formal hypothesis testing was performed.||||Change from baseline to Week 18 in EORTC-QLQ-C30 GHS/QoL combined score was compared between all participants of the pembro combo arm and the chemo arm. Comparison based on constrained longitudinal data analysis (cLDA) model with GHS/QoL score as response variable, and with treatment by study visit interactions and stratification factors (investigator's choice of chemotherapy \[cisplatin or carboplatin\] and PD-L1 status \[CPS\<10 vs. CPS≥10\]) at baseline as covariates.||6.12|-0.76|
72502259|NCT02698410|144534881|OTHER||||||<|0.0001||||||One-sided p-value estimated using an exact binomial proportion test for one-way tables comparing DCR to 10%.|Binomial proportion test|||Sensitivity Analyisis-2: Comparison of DCR to 10% clinically relevant threshold.||||<0.0001
72502260|NCT01584024|144534897|SUPERIORITY||||||=|0.003|||||||McNemar|||||||=0.003
72502261|NCT01584024|144534898|SUPERIORITY||||||=|0.17|||||||McNemar|||||||=0.17
72502262|NCT04893265|144534921|SUPERIORITY||Mean Difference (Net)|0.0854|STANDARD_ERROR_OF_MEAN|0.1122||0.4471|TWO_SIDED|95.0|-0.1352|0.306|||Mixed Models Analysis|||||0.3060|-0.1352|0.4471
72502263|NCT04893265|144534922|SUPERIORITY||Odds Ratio (OR)|0.8378|||<|0.05|TWO_SIDED|95.0|0.4284|1.6385|||Mixed Models Analysis|Adjusted for Demographics, COVID-19 Cases Per 100K , Test Access, Social Network, Knowledge, Test Value with random intercepts for participation mode|Adjusted odds ratio|||1.6385|0.4284|<0.05
72502264|NCT04893265|144534923|SUPERIORITY||Odds Ratio (OR)|1.4306|||<|0.05|TWO_SIDED|95.0|0.6166|3.3192|||Mixed Models Analysis|Adjusted for Demographics, COVID-19 Cases Per 100K , Test Access, Social Network, Knowledge, Test Value with random intercepts for participation mode|Adjusted odds ratio|||3.3192|0.6166|<0.05
72502265|NCT04893265|144534924|SUPERIORITY||Mean Difference (Final Values)|0.08661|STANDARD_ERROR_OF_MEAN|0.08125|||TWO_SIDED|95.0|-0.07311|0.2463|||||Adjusted for Demographics, COVID Cases Per 100,000 Population, Test Access, Social Network, Knowledge, and Test Value with random intercepts for Dyad and Individual|||0.2463|-0.07311|
72502266|NCT00893789|144534929|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8336||95.0||||The analyses performed were not done in accordance to the study protocol as the study was terminated early and therefore the analyses done were underpowered, no adjustments for multiple comparisons (or step-down analysis rules) were applied.|ANCOVA|||"P-value for Change from Baseline at Endpoint."||||0.8336
72502267|NCT00893789|144534929|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0514||95.0||||The analyses performed were not done in accordance to the study protocol as the study was terminated early and therefore the analyses done were underpowered, no adjustments for multiple comparisons (or step-down analysis rules) were applied.|ANCOVA|||"P-value for Change from Baseline at Endpoint."||||0.0514
72502268|NCT00893789|144534929|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001||95.0||||The analyses performed were not done in accordance to the study protocol as the study was terminated early and therefore the analyses done were underpowered, no adjustments for multiple comparisons (or step-down analysis rules) were applied.|ANCOVA|||"P-value for Change from Baseline at Endpoint."||||0.0010
72502269|NCT00893789|144534930|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7884||95.0|||||Pearson's chi-squared|||||||0.7884
72502270|NCT00893789|144534930|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2359||95.0|||||Pearson's chi-squared|||||||0.2359
72502271|NCT00893789|144534930|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4401||95.0|||||Pearson's chi-squared|||||||0.4401
72502272|NCT03818815|144534956|SUPERIORITY|||||||0.62||||||The p-value was calculated using multiple imputation with number of imputations equal to percentage of missing data.|Regression, Logistic|||The summary statistics are based on subjects with non-missing data only.||||0.62
72502273|NCT03818815|144534957|SUPERIORITY|||||||0.07||||||The p-value was calculated using multiple imputation with number of imputations equal to percentage of missing data.|Regression, Logistic|||The summary statistics are based on subjects with non-missing data only.||||0.07
72563876|NCT01546922|144659082|SUPERIORITY_OR_OTHER|||||||0.229||||||A Bonferroni correction for multiple comparisons was applied, resulting in a significance level of 0.001.|Wilcoxon (Mann-Whitney)|||Visual scanning - Number of omission errors||||0.229
72563877|NCT01546922|144659082|SUPERIORITY_OR_OTHER|||||||0.329||||||A Bonferroni correction for multiple comparisons was applied, resulting in a significance level of 0.001.|Wilcoxon (Mann-Whitney)|||Visual scanning - Number of commission errors||||0.329
72563878|NCT01546922|144659082|SUPERIORITY_OR_OTHER|||||||0.192||||||A Bonferroni correction for multiple comparisons was applied, resulting in a significance level of 0.001.|Wilcoxon (Mann-Whitney)|||Alertness - Reaction time tonic alertness||||0.192
72563879|NCT01546922|144659082|SUPERIORITY_OR_OTHER|||||||0.164||||||A Bonferroni correction for multiple comparisons was applied, resulting in a significance level of 0.001.|Wilcoxon (Mann-Whitney)|||Alertness - Reaction time phasic alertness||||0.164
72563880|NCT01546922|144659082|SUPERIORITY_OR_OTHER|||||||0.536||||||A Bonferroni correction for multiple comparisons was applied, resulting in a significance level of 0.001.|Wilcoxon (Mann-Whitney)|||Semantic fluency||||0.536
72563881|NCT01546922|144659082|SUPERIORITY_OR_OTHER|||||||0.572||||||A Bonferroni correction for multiple comparisons was applied, resulting in a significance level of 0.001.|Wilcoxon (Mann-Whitney)|||Phonemic fluency||||0.572
72502274|NCT01021007|144534980|SUPERIORITY_OR_OTHER|||||||0.005||95.0|||||ANCOVA|ANCOVA method using treatment as the factor and the baseline score as a covariate||The null hypothesis states that there is no difference between groups.||||0.005
72502275|NCT01021007|144534981|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|ANCOVA method using treatment as the factor and the baseline score as a covariate||The null hypothesis states that there is no difference between groups.||||0.05
72502276|NCT01021007|144534982|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|ANCOVA method using treatment as the factor and the baseline score as a covariate||The null hypothesis states that there is no difference between groups.||||0.05
72502277|NCT00087438|144534983|SUPERIORITY_OR_OTHER|||||||0.013||||||Test statistic = \[ln(estimated hazard rate) - ln(hypothesized hazard rates)\] / \[1/square root (number of patients with local progression by two years\]. Reject null hypothesis at an alpha level of 0.05 if test statistics is less than -1.645.|z-test, one-sided|||Null hypothesis = 60% two-year local control (0.02128/mo. hazard rate); alternative = 80% (0.0093/mo.) assuming at least approximately exponential distribution of time to local progression. Using the asymptotic properties of the ratio of the logarithms of hazard rates, less than 18 cases of local progression were required for a Type I error rate of 0.05 with 80% power to detect a difference in local control rates at least this large. Hazard rate estimated using life table two-year estimates.||||0.013
72502278|NCT03133767|144535051|SUPERIORITY|||||||0.608|||||||Wilcoxon (Mann-Whitney)|||||||0.608
72502279|NCT03133767|144535052|SUPERIORITY|||||||0.027|||||||Wilcoxon (Mann-Whitney)|||||||0.027
72502280|NCT03133767|144535053|SUPERIORITY|||||||0.202|||||||Chi-squared|||||||0.202
72502281|NCT03133767|144535054|SUPERIORITY|||||||0.361|||||||Chi-squared|||||||0.361
72502282|NCT03133767|144535055|SUPERIORITY|||||||0.509|||||||Chi-squared|||||||0.509
72502283|NCT03664726|144535056|SUPERIORITY|||||||0.0034||||||Comparison of differences by group|ANOVA|||||||0.0034
72502284|NCT03664726|144535057|SUPERIORITY|||||||0.76|||||||ANOVA|||||||0.76
72502285|NCT03664726|144535058|SUPERIORITY|||||||0.77|||||||ANOVA|||||||0.77
72502286|NCT05480514|144535067|SUPERIORITY|A superiority margin of 0.90 was used. Superiority was concluded if the lower bound of the 95% central posterior credible interval was above 0.90.|Mean Posterior Proportion|0.9741|STANDARD_DEVIATION|0.01244|||TWO_SIDED|95.0|0.9445|0.9926|||Bayesian beta-binomial model|||||0.9926|0.9445|
72502287|NCT00457639|144535068|SUPERIORITY||Mean Difference (Net)|13.8||||0.42|TWO_SIDED|95.0|-19.7|61.1|||Mixed Models Analysis|||||61.1|-19.7|0.42
72463970|NCT02853305|144450662|OTHER||Hazard Ratio (HR)|0.78|||||TWO_SIDED|95.0|0.62|1.0||No formal hypothesis testing was performed.||||TTD in GHS/QoL combined score was compared between all participants of the pembro combo arm and the chemo arm. Comparison based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by investigator's choice of chemotherapy (cisplatin or carboplatin) and PD-L1 status (CPS\<10 vs. CPS≥10) at baseline.||1.00|0.62|
72502288|NCT00457639|144535069|SUPERIORITY||Mean Difference (Final Values)|11.4||||0.45|TWO_SIDED|95.0|-17.7|50.8|||Mixed Models Analysis|||||50.8|-17.7|0.45
72502289|NCT02559505|144535094|OTHER|||||||0.005||||||p-value for H3 reactivity, difference of Acute Infected vs. Vaccinated.|ANCOVA|||||||0.005
72502290|NCT02559505|144535094|OTHER|||||||0.024||||||p-value for NP reactivity, difference of Acute Infected vs. Vaccinated.|ANCOVA|||||||0.024
72502291|NCT02559505|144535095|OTHER|||||||0.408||||||p-value for H3 reactivity, difference of Acute Infected vs. Vaccinated.|ANCOVA|||||||0.408
72502292|NCT02559505|144535095|OTHER|||||||0.004||||||p-value for NP reactivity, difference of Acute Infected vs. Vaccinated.|ANCOVA|||||||0.004
72502293|NCT02559505|144535096|OTHER|||||||0.991||||||p-value for H3 reactivity, difference of Acute Infected vs. Vaccinated.|ANCOVA|||||||0.991
72463971|NCT02853305|144450663|OTHER||Difference in LS Means|-0.94|||||TWO_SIDED|95.0|-5.06|3.18||No formal hypothesis testing was performed.||||Change from baseline to Week 18 in EORTC-QLQ-C30 GHS/QoL combined score was compared between all participants of the pembro arm and the chemo arm. Comparison based on cLDA model with GHS/QoL score as response variable, and with treatment by study visit interactions and stratification factors (investigator's choice of chemotherapy \[cisplatin or carboplatin\] and PD-L1 status \[CPS\<10 vs. CPS≥10\]) at baseline as covariates.||3.18|-5.06|
72463972|NCT02853305|144450664|OTHER||Hazard Ratio (HR)|1.18|||||TWO_SIDED|95.0|0.93|1.49||No formal hypothesis testing was performed.||||TTD in GHS/QoL combined score was compared between all participants of the pembro arm and the chemo arm. Comparison based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by investigator's choice of chemotherapy (cisplatin or carboplatin) and PD-L1 status (CPS\<10 vs. CPS≥10) at baseline.||1.49|0.93|
72502294|NCT02559505|144535096|OTHER|||||||0.334||||||p-value for NP reactivity, difference of Acute Infected vs. Vaccinated.|ANCOVA|||||||0.334
72563882|NCT01546922|144659082|SUPERIORITY_OR_OTHER|||||||0.632||||||A Bonferroni correction for multiple comparisons was applied, resulting in a significance level of 0.001.|Wilcoxon (Mann-Whitney)|||Digit span backward - Working memory||||0.632
72502295|NCT02559505|144535097|OTHER|||||||0.226||||||p-value for H3 reactivity, difference of Acute Infected vs. Vaccinated.|ANCOVA|||||||0.226
72502296|NCT02559505|144535097|OTHER|||||||0.036||||||p-value for NP reactivity, difference of Acute Infected vs. Vaccinated.|ANCOVA|||||||0.036
72502297|NCT02559505|144535098|OTHER|||||||0.68||||||p-value for H3 reactivity, difference of Acute Infected vs. Vaccinated.|ANCOVA|||||||0.680
72502298|NCT02559505|144535098|OTHER|||||||0.002||||||p-value for H3 reactivity, difference of Acute Infected vs. Vaccinated.|ANCOVA|||||||0.002
72502299|NCT04331899|144535115|OTHER||Cox Proportional Hazard|0.81||||0.29|TWO_SIDED|95.0|0.56|1.19||Tests were conducted at the 0.05 level of significance.|Regression, Cox||Cox proportional hazards model covariate-adjusted for age 50+ and sex.|||1.19|0.56|0.29
72502300|NCT04331899|144535116|OTHER||Cox Proportional Hazard|-0.06||||0.91|TWO_SIDED|95.0|-1.23|1.11||Tests were conducted at the 0.05 level of significance.|Regression, Linear||Log change at Day 14. Cox proportional hazards model covariate-adjusted for age 50+ and sex.|||1.11|-1.23|0.91
72563883|NCT01546922|144659082|SUPERIORITY_OR_OTHER|||||||0.512||||||A Bonferroni correction for multiple comparisons was applied, resulting in a significance level of 0.001.|Wilcoxon (Mann-Whitney)|||Trail Making Test - Time condition A||||0.512
72463973|NCT02381652|144450666|OTHER|Statistical test to see if there is a difference||||||0.3108|||||||Fisher Exact|||||||0.3108
72502301|NCT04331899|144535117|OTHER||Cox Proportional Hazard|1.01||||0.95|TWO_SIDED|95.0|0.85|1.16||Tests were conducted at the 0.05 level of significance.|Regression, Linear||Cox proportional hazards model covariate-adjusted for age 50+ and sex.|||1.16|0.85|0.95
72502302|NCT04331899|144535118|OTHER||Cox Proportional Hazard|0.94||||0.76|TWO_SIDED|95.0|0.6|1.41||Tests were conducted at the 0.05 level of significance.|Regression, Cox||Cox proportional hazards model covariate-adjusted for age 50+ and sex.|||1.41|0.60|0.76
72502303|NCT00101361|144535120|NON_INFERIORITY_OR_EQUIVALENCE|the required sample size of 400 participants provided 85% power to detect an increase in healing from 25% in the placebo group to 40% in the oxandrolone group, as assuming a 0.05 (2-sided) type I error, 13% rate of loss to follow up, and a test of proportions by using an arcsine transformation.|Mean Difference (Final Values)|-5.7|||<|0.05|TWO_SIDED|95.0|-17.5|6.8|||Cochran-Mantel-Haenszel|||For spinal cord injury patients with a Stage III or IV pressure ulcer of the pelvic region who receive 24 weeks or less of optimized clinical care (i.e., guideline-driven care with nutritional support) compared with optimized clinical care and an oral anabolic steroid agent (oxandrolone) there will be no difference in the percent of healed pressure ulcers.||6.8|-17.5|<0.05
72502304|NCT02424539|144535121|OTHER||Mean Difference (Final Values)|-1.23|||<|0.001|TWO_SIDED|95.0|-1.68|-0.78|||ANCOVA||Least square (LS) mean difference between placebo and FF 55 µg QD has been presented using analysis of co-variance (ANCOVA) model adjusted for treatment, Baseline value, gender, age and type of Allergic Rhinitis.|||-0.78|-1.68|<0.001
72563884|NCT01546922|144659082|SUPERIORITY_OR_OTHER|||||||0.861||||||A Bonferroni correction for multiple comparisons was applied, resulting in a significance level of 0.001.|Wilcoxon (Mann-Whitney)|||Trail Making Test - Time condition B||||0.861
72502305|NCT02424539|144535121|OTHER||Mean Difference (Final Values)|-1.32|||<|0.001|TWO_SIDED|95.0|-1.77|-0.87|||ANCOVA||LS mean difference between placebo and FF 110 µg QD has been presented using ANCOVA model adjusted for treatment, Baseline value, gender, age and type of Allergic Rhinitis.|||-0.87|-1.77|<0.001
72502306|NCT02424539|144535122|OTHER||Odds Ratio (OR)|0.24|||<|0.001|TWO_SIDED|95.0|0.14|0.39|||Regression, Logistic||Odds ratio for FF 55 µg QD versus placebo has been presented using a logistic regression model with Wald's test with treatment, gender, age and type of Allergic Rhinitis as factors.|||0.39|0.14|<0.001
72502307|NCT02424539|144535122|OTHER||Odds Ratio (OR)|0.2|||<|0.001|TWO_SIDED|95.0|0.12|0.33|||Regression, Logistic||Odds ratio for FF 110 µg QD versus placebo has been presented using a logistic regression model with Wald's test with treatment, gender, age and type of Allergic Rhinitis as factors.|||0.33|0.12|<0.001
72463974|NCT01340300|144450667|SUPERIORITY||||||<|0.0001||||||One-sided un-adjusted p-values to test if the decrease in treatment arm is greater than the control arm. Holm's method was performed for multiple comparisons to provide an overall significance level of 5%. Only significant p-values were reported.|Mixed Models Analysis|An intention-to-treat analysis, with a mixed model that was adjusted for baseline outcome value, BMI (\< 30 or \> 30), gender, cancer, and study site.||Null hypothesis: decrease of insulin in treatment arm is greater than the control arm.||||<0.0001
72463975|NCT01340300|144450667|SUPERIORITY|||||||0.003||||||One-sided un-adjusted p-values to test if the decrease in treatment arm is greater than the control arm. Holm's method was performed for multiple comparisons to provide an overall significance level of 5%. Only significant p-values were reported.|Mixed Models Analysis|An intention-to-treat analysis, with a mixed model that was adjusted for baseline outcome value, BMI (\< 30 or \> 30), gender, cancer, and study site.||Null hypothesis: decrease of insulin in treatment arm is greater than the control arm.||||0.003
72463976|NCT01340300|144450667|SUPERIORITY|||||||0.01||||||One-sided un-adjusted p-values to test if the decrease in treatment arm is greater than the control arm. Holm's method was performed for multiple comparisons to provide an overall significance level of 5%. Only significant p-values were reported.|Mixed Models Analysis|An intention-to-treat analysis, with a mixed model that was adjusted for baseline outcome value, BMI (\< 30 or \> 30), gender, cancer, and study site.||Null hypothesis: decrease of insulin in treatment arm is greater than the control arm.||||0.01
72463977|NCT01340300|144450667|SUPERIORITY|||||||0.03||||||One-sided un-adjusted p-values to test if the decrease in treatment arm is greater than the control arm. Holm's method was performed for multiple comparisons to provide an overall significance level of 5%. Only significant p-values were reported.|Mixed Models Analysis|An intention-to-treat analysis, with a mixed model that was adjusted for baseline outcome value, BMI (\< 30 or \> 30), gender, cancer, and study site.||Null hypothesis: decrease of Insulin in combined arm is greater than the exercise-only or metformin-only arm.||||0.03
72463978|NCT01340300|144450668|SUPERIORITY|||||||0.0002||||||One-sided un-adjusted p-values to test if the decrease in treatment arm is greater than the control arm. Holm's method was performed for multiple comparisons to provide an overall significance level of 5%. Only significant p-values were reported.|Mixed Models Analysis|An intention-to-treat analysis, with a mixed model that was adjusted for baseline outcome value, BMI (\< 30 or \> 30), gender, cancer, and study site.||Null hypothesis: decrease of leptin in treatment arm is greater than the control arm.||||0.0002
72463979|NCT01340300|144450668|SUPERIORITY|||||||0.002||||||One-sided un-adjusted p-values to test if the decrease in treatment arm is greater than the control arm. Holm's method was performed for multiple comparisons to provide an overall significance level of 5%. Only significant p-values were reported.|Mixed Models Analysis|An intention-to-treat analysis, with a mixed model that was adjusted for baseline outcome value, BMI (\< 30 or \> 30), gender, cancer, and study site.||Null hypothesis: decrease of IGFBP\_1 in treatment arm is greater than the control arm.||||0.002
72463980|NCT01340300|144450668|SUPERIORITY|||||||0.02||||||One-sided un-adjusted p-values to test if the decrease in treatment arm is greater than the control arm. Holm's method was performed for multiple comparisons to provide an overall significance level of 5%. Only significant p-values were reported.|Mixed Models Analysis|An intention-to-treat analysis, with a mixed model that was adjusted for baseline outcome value, BMI (\< 30 or \> 30), gender, cancer, and study site.||Null hypothesis: decrease of IGFBP\_1 in treatment arm is greater than the control arm.||||0.02
72502308|NCT02424539|144535123|OTHER||Mean Difference (Final Values)|-2.15|||<|0.001|TWO_SIDED|95.0|-2.84|-1.46|||ANCOVA||LS mean difference between placebo and FF 55 µg QD has been presented using ANCOVA model adjusted for treatment, Baseline value, gender, age and type of Allergic Rhinitis.|||-1.46|-2.84|<0.001
72502309|NCT02424539|144535123|OTHER||Mean Difference (Final Values)|-1.98|||<|0.001|TWO_SIDED|95.0|-2.66|-1.29|||ANCOVA||LS mean difference between placebo and FF 110 µg QD has been presented using ANCOVA model adjusted for treatment, Baseline value, gender, age and type of Allergic Rhinitis.|||-1.29|-2.66|<0.001
72502310|NCT02424539|144535124|OTHER||Mean Difference (Final Values)|-0.1||||0.503|TWO_SIDED|95.0|-0.38|0.18|||ANCOVA||LS mean difference between placebo and FF 55 µg QD has been presented using ANCOVA model adjusted for treatment, Baseline value, gender, age and type of Allergic Rhinitis.|||0.18|-0.38|0.503
72502311|NCT02424539|144535124|OTHER||Mean Difference (Final Values)|-0.25||||0.078|TWO_SIDED|95.0|-0.53|0.03|||ANCOVA||LS mean difference between placebo and FF 110 µg QD has been presented using ANCOVA model adjusted for treatment, Baseline value, gender, age and type of Allergic Rhinitis.|||0.03|-0.53|0.078
72502312|NCT02424539|144535125|OTHER||Mean Difference (Final Values)|0.51||||0.048|TWO_SIDED|95.0|0.01|1.02|||ANCOVA||LS mean difference between placebo and FF 55 µg QD has been presented using ANCOVA model adjusted for treatment, Baseline value, gender, age and type of Allergic Rhinitis.|||1.02|0.01|0.048
72502313|NCT02424539|144535125|OTHER||Mean Difference (Final Values)|0.66||||0.011|TWO_SIDED|95.0|0.16|1.17|||ANCOVA||LS mean difference between placebo and FF 110 µg QD has been presented using ANCOVA model adjusted for treatment, Baseline value, gender, age and type of Allergic Rhinitis.|||1.17|0.16|0.011
72502314|NCT02424539|144535126|OTHER||Mean Difference (Final Values)|-1.36|||<|0.001|TWO_SIDED|95.0|-1.83|-0.9|||ANCOVA||LS mean difference between placebo and FF 55 µg QD has been presented using ANCOVA model adjusted for treatment, Baseline value, gender, age and type of Allergic Rhinitis.|||-0.90|-1.83|<0.001
72563885|NCT01546922|144659082|SUPERIORITY_OR_OTHER|||||||0.958||||||A Bonferroni correction for multiple comparisons was applied, resulting in a significance level of 0.001.|Wilcoxon (Mann-Whitney)|||Trail Making Test - Condition B/A||||0.958
72563886|NCT01546922|144659082|SUPERIORITY_OR_OTHER|||||||0.819||||||A Bonferroni correction for multiple comparisons was applied, resulting in a significance level of 0.001.|Wilcoxon (Mann-Whitney)|||Social cognition||||0.819
72563887|NCT02285634|144659111|SUPERIORITY|||||||0.42|||||||Fisher Exact|||||||0.42
72502315|NCT02424539|144535126|OTHER||Mean Difference (Final Values)|-1.46|||<|0.001|TWO_SIDED|95.0|-1.92|-0.99|||ANCOVA||LS mean difference between placebo and FF 110 µg QD has been presented using ANCOVA model adjusted for treatment, Baseline value, gender, age and type of Allergic Rhinitis.|||-0.99|-1.92|<0.001
72502316|NCT02424539|144535127|OTHER||Odds Ratio (OR)|0.2|||<|0.001|TWO_SIDED|95.0|0.12|0.34|||Regression, Logistic||Odds ratio for FF 55 µg QD versus placebo has been presented using a logistic regression model with Wald's test with treatment, gender, age and type of Allergic Rhinitis as factors.|||0.34|0.12|<0.001
72563888|NCT02285634|144659111|SUPERIORITY|||||||0.52|||||||Fisher Exact|||||||0.52
72463981|NCT01340300|144450668|SUPERIORITY|||||||0.0002||||||One-sided un-adjusted p-values to test if the decrease in treatment arm is greater than the control arm. Holm's method was performed for multiple comparisons to provide an overall significance level of 5%. Only significant p-values were reported.|Mixed Models Analysis|An intention-to-treat analysis, with a mixed model that was adjusted for baseline outcome value, BMI (\< 30 or \> 30), gender, cancer, and study site.||Null hypothesis: decrease of Leptin in combined arm is greater than the exercise-only or metformin-only arm.||||0.0002
72463982|NCT01340300|144450668|SUPERIORITY|||||||0.02||||||One-sided un-adjusted p-values to test if the decrease in treatment arm is greater than the control arm. Holm's method was performed for multiple comparisons to provide an overall significance level of 5%. Only significant p-values were reported.|Mixed Models Analysis|An intention-to-treat analysis, with a mixed model that was adjusted for baseline outcome value, BMI (\< 30 or \> 30), gender, cancer, and study site.||Null hypothesis: decrease of Leptin in combined arm is greater than the exercise-only or metformin-only arm.||||0.02
72463983|NCT01340300|144450669|SUPERIORITY|||||||0.0004||||||One-sided un-adjusted p-values to test if the decrease in treatment arm is greater than the control arm. Holm's method was performed for multiple comparisons to provide an overall significance level of 5%. Only significant p-values were reported.|Mixed Models Analysis|An intention-to-treat analysis, with a mixed model that was adjusted for baseline outcome value, BMI (\< 30 or \> 30), gender, cancer, and study site.||Null hypothesis: decrease of Glucose in treatment arm is greater than the control arm.||||0.0004
72463984|NCT01340300|144450669|SUPERIORITY|||||||0.007||||||One-sided un-adjusted p-values to test if the decrease in treatment arm is greater than the control arm. Holm's method was performed for multiple comparisons to provide an overall significance level of 5%. Only significant p-values were reported.|Mixed Models Analysis|An intention-to-treat analysis, with a mixed model that was adjusted for baseline outcome value, BMI (\< 30 or \> 30), gender, cancer, and study site.||Null hypothesis: decrease of Glucose in treatment arm is greater than the control arm.||||0.007
72463985|NCT01340300|144450670|SUPERIORITY||||||<|0.0001||||||One-sided un-adjusted p-values to test if the decrease in treatment arm is greater than the control arm. Holm's method was performed for multiple comparisons to provide an overall significance level of 5%. Only significant p-values were reported.|Mixed Models Analysis|An intention-to-treat analysis, with a mixed model that was adjusted for baseline outcome value, BMI (\< 30 or \> 30), gender, cancer, and study site.||Null hypothesis: decrease of Weight in treatment arm is greater than the control arm.||||<0.0001
72463986|NCT01340300|144450670|SUPERIORITY||||||<|0.0001||||||One-sided un-adjusted p-values to test if the decrease in treatment arm is greater than the control arm. Holm's method was performed for multiple comparisons to provide an overall significance level of 5%. Only significant p-values were reported.|Mixed Models Analysis|An intention-to-treat analysis, with a mixed model that was adjusted for baseline outcome value, BMI (\< 30 or \> 30), gender, cancer, and study site.||Null hypothesis: decrease of Weight in treatment arm is greater than the control arm.||||<0.0001
72463987|NCT01340300|144450670|SUPERIORITY|||||||0.01||||||One-sided un-adjusted p-values to test if the decrease in treatment arm is greater than the control arm. Holm's method was performed for multiple comparisons to provide an overall significance level of 5%. Only significant p-values were reported.|Mixed Models Analysis|An intention-to-treat analysis, with a mixed model that was adjusted for baseline outcome value, BMI (\< 30 or \> 30), gender, cancer, and study site.||Null hypothesis: decrease of Weight in treatment arm is greater than the control arm.||||0.01
72463988|NCT01340300|144450671|SUPERIORITY||||||<|0.0001||||||One-sided un-adjusted p-values to test if the decrease in treatment arm is greater than the control arm. Holm's method was performed for multiple comparisons to provide an overall significance level of 5%. Only significant p-values were reported.|Mixed Models Analysis|An intention-to-treat analysis, with a mixed model that was adjusted for baseline outcome value, BMI (\< 30 or \> 30), gender, cancer, and study site.||Null hypothesis: decrease of BMI in treatment arm is greater than the control arm.||||<0.0001
72463989|NCT01340300|144450671|SUPERIORITY||||||<|0.0001||||||One-sided un-adjusted p-values to test if the decrease in treatment arm is greater than the control arm. Holm's method was performed for multiple comparisons to provide an overall significance level of 5%. Only significant p-values were reported.|Mixed Models Analysis|An intention-to-treat analysis, with a mixed model that was adjusted for baseline outcome value, BMI (\< 30 or \> 30), gender, cancer, and study site.||Null hypothesis: decrease of BMI in treatment arm is greater than the control arm.||||<0.0001
72502317|NCT02424539|144535127|OTHER||Odds Ratio (OR)|0.17|||<|0.001|TWO_SIDED|95.0|0.1|0.29|||Regression, Logistic||Odds ratio for FF 110 µg QD versus placebo has been presented using a logistic regression model with Wald's test with treatment, gender, age and type of Allergic Rhinitis as factors.|||0.29|0.10|<0.001
72502318|NCT02424539|144535128|OTHER||Mean Difference (Final Values)|-2.48|||<|0.001|TWO_SIDED|95.0|-3.23|-1.73|||ANCOVA||LS mean difference between placebo and FF 55 µg QD has been presented using ANCOVA model adjusted for treatment, Baseline value, gender, age and type of Allergic Rhinitis.|||-1.73|-3.23|<0.001
72502319|NCT02424539|144535128|OTHER||Mean Difference (Final Values)|-2.27|||<|0.001|TWO_SIDED|95.0|-3.03|-1.52|||ANCOVA||LS mean difference between placebo and FF 110 µg QD has been presented using ANCOVA model adjusted for treatment, Baseline value, gender, age and type of Allergic Rhinitis.|||-1.52|-3.03|<0.001
72502320|NCT02424539|144535129|OTHER||Mean Difference (Final Values)|-0.11||||0.442|TWO_SIDED|95.0|-0.38|0.17|||ANCOVA||LS mean difference between placebo and FF 55 µg QD has been presented using ANCOVA model adjusted for treatment, Baseline value, gender, age and type of Allergic Rhinitis.|||0.17|-0.38|0.442
72502321|NCT02424539|144535129|OTHER||Mean Difference (Final Values)|-0.3||||0.035|TWO_SIDED|95.0|-0.57|-0.02|||ANCOVA||LS mean difference between placebo and FF 110 µg QD has been presented using ANCOVA model adjusted for treatment, Baseline value, gender, age and type of Allergic Rhinitis.|||-0.02|-0.57|0.035
72502322|NCT02424539|144535130|OTHER||Mean Difference (Final Values)|1.88||||0.004|TWO_SIDED|95.0|0.6|3.16|||ANCOVA||LS mean difference between placebo and FF 55 µg QD has been presented using ANCOVA model adjusted for treatment, Baseline value, gender, age and type of Allergic Rhinitis.|||3.16|0.60|0.004
72502323|NCT02424539|144535130|OTHER||Mean Difference (Final Values)|2.67|||<|0.001|TWO_SIDED|95.0|1.38|3.95|||ANCOVA||LS mean difference between placebo and FF 110 µg QD has been presented using ANCOVA model adjusted for treatment, Baseline value, gender, age and type of Allergic Rhinitis.|||3.95|1.38|<0.001
72563889|NCT02285634|144659111|SUPERIORITY|||||||0.93|||||||Fisher Exact|||||||0.93
72563890|NCT02285634|144659112|SUPERIORITY|||||||0.06|||||||Fisher Exact|||||||0.06
72463990|NCT01340300|144450671|SUPERIORITY|||||||0.02||||||One-sided un-adjusted p-values to test if the decrease in treatment arm is greater than the control arm. Holm's method was performed for multiple comparisons to provide an overall significance level of 5%. Only significant p-values were reported.|Mixed Models Analysis|An intention-to-treat analysis, with a mixed model that was adjusted for baseline outcome value, BMI (\< 30 or \> 30), gender, cancer, and study site.||Null hypothesis: decrease of BMI in treatment arm is greater than the control arm.||||0.02
72463991|NCT01340300|144450672|SUPERIORITY|||||||0.01||||||One-sided un-adjusted p-values to test if the decrease in treatment arm is greater than the control arm. Holm's method was performed for multiple comparisons to provide an overall significance level of 5%. Only significant p-values were reported.|Mixed Models Analysis|An intention-to-treat analysis, with a mixed model that was adjusted for baseline outcome value, BMI (\< 30 or \> 30), gender, cancer, and study site.||Null hypothesis: decrease of Waist to Hip Ratio in treatment arm is greater than the control arm.||||0.01
72502324|NCT01475955|144535169|SUPERIORITY_OR_OTHER|||||||0.0041||95.0|||||Chi-squared|||Pearson chi-square||||0.0041
72502325|NCT03047005|144535259|SUPERIORITY|Analyses used all available data. Analyses to compare treatments were all intent-to-treat.||||||0.07|||||||Mixed Models Analysis|Analyses were performed for all randomized patients who attended the first treatment session. Model adjusted for stage 1 treatment condition.||||||.07
72502326|NCT03047005|144535260|SUPERIORITY|Analyses used all available data. Analyses to compare treatments were all intent-to-treat.||||||0.01|||||||Mixed Models Analysis|Analyses were performed for all randomized patients who attended the first treatment session. Model adjusted for stage 1 treatment condition.||||||.01
72502327|NCT01929083|144535271|SUPERIORITY_OR_OTHER|||||||0.04|TWO_SIDED||||||t-test, 2 sided|Paired t-test||||||0.04
72502328|NCT01929083|144535272|SUPERIORITY_OR_OTHER|||||||0.003|TWO_SIDED||||||t-test, 2 sided|Paired t-test||||||0.003
72502329|NCT01929083|144535273|SUPERIORITY_OR_OTHER|||||||0.04|TWO_SIDED|||||P value for incidence of fatigue/malaise|Fisher Exact|||||||0.04
72502330|NCT01929083|144535273|SUPERIORITY_OR_OTHER|||||||0.6|TWO_SIDED|||||p values for incidence of headache|Fisher Exact|||||||0.60
72502331|NCT01929083|144535273|SUPERIORITY_OR_OTHER|||||||0.23|TWO_SIDED|||||p value for incidence of mood changes|Fisher Exact|||||||0.23
72502332|NCT01929083|144535273|SUPERIORITY_OR_OTHER|||||||0.23|TWO_SIDED|||||p value for incidence of breast tenderness|Fisher Exact|||||||0.23
72502333|NCT01929083|144535273|SUPERIORITY_OR_OTHER|||||||0.48|TWO_SIDED|||||p value for incidence of hypotension|Fisher Exact|||||||0.48
72502334|NCT01929083|144535273|SUPERIORITY_OR_OTHER|||||||0.48|TWO_SIDED|||||p value for incidence of vertigo requiring discontinuation of therapy|Fisher Exact|||||||0.48
72502335|NCT01929083|144535274|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED||||||t-test, 2 sided|Paired t-test||||||0.02
72502336|NCT01929083|144535275|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED||||||t-test, 2 sided|Paired t-test||||||0.002
72502337|NCT01929083|144535276|SUPERIORITY_OR_OTHER|||||||0.65|TWO_SIDED|||||p value for bradycardia|Fisher Exact|||||||0.65
72502338|NCT01929083|144535276|SUPERIORITY_OR_OTHER||||||>|0.99|TWO_SIDED|||||p value for burning at infusion site|Fisher Exact|||||||>0.99
72502339|NCT01929083|144535276|SUPERIORITY_OR_OTHER||||||>|0.99|TWO_SIDED|||||p value for transient QTc interval \> 500 ms|Fisher Exact|||||||> 0.99
72502340|NCT01929083|144535277|SUPERIORITY_OR_OTHER|||||||0.43|TWO_SIDED||||||t-test, 2 sided|Paired t-test||||||0.43
72502341|NCT01929083|144535278|SUPERIORITY_OR_OTHER|||||||0.36|TWO_SIDED||||||t-test, 2 sided|Paired t-test||||||0.36
72502342|NCT01929083|144535279|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||t-test, 2 sided|Paired t-test||||||<0.0001
72502343|NCT01929083|144535280|SUPERIORITY_OR_OTHER|||||||0.0001|TWO_SIDED||||||t-test, 2 sided|Paired t-test||||||0.0001
72502344|NCT02586805|144535292|OTHER||% change in mean rate (vs placebo)|-75.609|||<|0.001|TWO_SIDED|95.0|-84.65|-61.243||p-values are adjusted for multiple testing.|Chi-squared||% change in mean rate corresponds to 100% \* (estimated mean rate ratio - 1).||Results from Poisson regression model with fixed effects for treatment group (categorical) and normalized baseline attack rate (continuous), and logarithm of time in days each participant was observed during treatment period as offset variable in model. Pearson chi-square scaling of standards errors was employed to account for potential overdispersion. Mean estimates are Least Squares (LS) means.|-61.243|-84.650|<0.001
72502345|NCT02586805|144535292|OTHER||% change in mean rate (vs placebo)|-73.271|||<|0.001|TWO_SIDED|95.0|-82.379|-59.456||p-values are adjusted for multiple testing.|Chi-squared||% change in mean rate corresponds to 100% \* (estimated mean rate ratio - 1)||Results from Poisson regression model with fixed effects for treatment group (categorical) and normalized baseline attack rate (continuous), and logarithm of time in days each participant was observed during treatment period as offset variable in model. Pearson chi-square scaling of standards errors was employed to account for potential overdispersion. Mean estimates are Least Squares (LS) means.|-59.456|-82.379|<0.001
72502346|NCT02586805|144535292|OTHER||% change in mean rate (vs placebo)|-86.921|||<|0.001|TWO_SIDED|95.0|-92.828|-76.15||p-values are adjusted for multiple testing.|Chi-squared||% change in mean rate corresponds to 100% \* (estimated mean rate ratio - 1)||Results from Poisson regression model with fixed effects for treatment group (categorical) and normalized baseline attack rate (continuous), and logarithm of time in days each participant was observed during treatment period as offset variable in model. Pearson chi-square scaling of standards errors was employed to account for potential overdispersion. Mean estimates are Least Squares (LS) means.|-76.150|-92.828|<0.001
72502347|NCT02586805|144535293|OTHER||% change in mean rate (vs placebo)|-80.842|||<|0.001|TWO_SIDED|95.0|-89.169|-66.114||p-values are adjusted for multiple testing.|Chi-squared||% change in mean rate corresponds to 100% \* (estimated mean rate ratio - 1).||Results from Poisson regression model with fixed effects for treatment group (categorical) and normalized baseline attack rate (continuous), and logarithm of time in days each participant was observed during treatment period as offset variable in model. Pearson chi-square scaling of standards errors was employed to account for potential overdispersion. Mean estimates are Least Squares (LS) means.|-66.114|-89.169|<0.001
72504817|NCT03114969|144540518|SUPERIORITY||Odds Ratio (OR)|1.738||||0.189|TWO_SIDED|95.0|0.761|3.968||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta+\[Relvar Ellipta+LAMA\] as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.|||3.968|0.761|0.189
72502348|NCT02586805|144535293|OTHER||% change in mean rate (vs placebo)|-74.169|||<|0.001|TWO_SIDED|95.0|-83.733|-58.983||p-values are adjusted for multiple testing.|Chi-squared||% change in mean rate corresponds to 100% \* (estimated mean rate ratio - 1)||Results from Poisson regression model with fixed effects for treatment group (categorical) and normalized baseline attack rate (continuous), and logarithm of time in days each participant was observed during treatment period as offset variable in model. Pearson chi-square scaling of standards errors was employed to account for potential overdispersion. Mean estimates are Least Squares (LS) means.|-58.983|-83.733|<0.001
72502349|NCT02586805|144535293|OTHER||% change in mean rate (vs placebo)|-87.299|||<|0.001|TWO_SIDED|95.0|-93.494|-75.204||p-values are adjusted for multiple testing.|Chi-squared||% change in mean rate corresponds to 100% \* (estimated mean rate ratio - 1)||Results from Poisson regression model with fixed effects for treatment group (categorical) and normalized baseline attack rate (continuous), and logarithm of time in days each participant was observed during treatment period as offset variable in model. Pearson chi-square scaling of standards errors was employed to account for potential overdispersion. Mean estimates are Least Squares (LS) means.|-75.204|-93.494|<0.001
72502350|NCT02586805|144535294|OTHER||% change in mean rate (vs placebo)|-70.497|||<|0.001|TWO_SIDED|95.0|-82.696|-49.699||p-values are adjusted for multiple testing.|Chi-squared||% change in mean rate corresponds to 100% \* (estimated mean rate ratio - 1)||Results from Poisson regression model with fixed effects for treatment group (categorical) and normalized baseline attack rate (continuous), and logarithm of time in days each participant was observed during treatment period as offset variable in model. Pearson chi-square scaling of standards errors was employed to account for potential overdispersion. Mean estimates are Least Squares (LS) means.|-49.699|-82.696|<0.001
72502351|NCT02586805|144535294|OTHER||% change in mean rate (vs placebo)|-73.285|||<|0.001|TWO_SIDED|95.0|-84.316|-54.496||p-values are adjusted for multiple testing.|Chi-squared||% change in mean rate corresponds to 100% \* (estimated mean rate ratio - 1)||Results from Poisson regression model with fixed effects for treatment group (categorical) and normalized baseline attack rate (continuous), and logarithm of time in days each participant was observed during treatment period as offset variable in model. Pearson chi-square scaling of standards errors was employed to account for potential overdispersion. Mean estimates are Least Squares (LS) means.|-54.496|-84.316|<0.001
72502352|NCT02586805|144535294|OTHER||% change in mean rate (vs placebo)|-83.394|||<|0.001|TWO_SIDED|95.0|-91.618|-67.099||p-values are adjusted for multiple testing.|Chi-squared||% change in mean rate corresponds to 100% \* (estimated mean rate ratio - 1)||Results from Poisson regression model with fixed effects for treatment group (categorical) and normalized baseline attack rate (continuous), and logarithm of time in days each participant was observed during treatment period as offset variable in model. Pearson chi-square scaling of standards errors was employed to account for potential overdispersion. Mean estimates are Least Squares (LS) means.|-67.099|-91.618|<0.001
72502353|NCT02586805|144535295|OTHER||% change in mean rate (vs placebo)|-77.622|||<|0.001|TWO_SIDED|95.0|-86.253|-63.572||p-values are adjusted for multiple testing.|Chi-squared||% change in mean rate corresponds to 100% \* (estimated mean rate ratio - 1).||Results from Poisson regression model with fixed effects for treatment group (categorical) and normalized baseline attack rate (continuous), and logarithm of time in days each participant was observed during treatment period as offset variable in model. Pearson chi-square scaling of standards errors was employed to account for potential overdispersion. Mean estimates are Least Squares (LS) means.|-63.572|-86.253|<0.001
72502354|NCT02586805|144535295|OTHER||% change in mean rate (vs placebo)|-75.377|||<|0.001|TWO_SIDED|95.0|-84.115|-61.833||p-values are adjusted for multiple testing.|Chi-squared||% change in mean rate corresponds to 100% \* (estimated mean rate ratio - 1).||Results from Poisson regression model with fixed effects for treatment group (categorical) and normalized baseline attack rate (continuous), and logarithm of time in days each participant was observed during treatment period as offset variable in model. Pearson chi-square scaling of standards errors was employed to account for potential overdispersion. Mean estimates are Least Squares (LS) means.|-61.833|-84.115|<0.001
72502355|NCT02586805|144535295|OTHER||% change in mean rate (vs placebo)|-89.008|||<|0.001|TWO_SIDED|95.0|-94.325|-78.707||p-values are adjusted for multiple testing.|Chi-squared||% change in mean rate corresponds to 100% \* (estimated mean rate ratio - 1).||Results from Poisson regression model with fixed effects for treatment group (categorical) and normalized baseline attack rate (continuous), and logarithm of time in days each participant was observed during treatment period as offset variable in model. Pearson chi-square scaling of standards errors was employed to account for potential overdispersion. Mean estimates are Least Squares (LS) means.|-78.707|-94.325|<0.001
72502356|NCT00500071|144535347|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||t-test, 1 sided|||Week 1||||< 0.0001
72502357|NCT00500071|144535347|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||t-test, 1 sided|||Week 2||||< 0.0001
72502358|NCT00500071|144535347|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||t-test, 1 sided|||Week 3||||< 0.0001
72502359|NCT00500071|144535347|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||t-test, 1 sided|||Week 4||||< 0.0001
72502360|NCT00500071|144535347|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||t-test, 1 sided|||Week 5||||< 0.0001
72502361|NCT00500071|144535347|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||t-test, 1 sided|||Week 6||||< 0.0001
72502362|NCT00500071|144535347|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||t-test, 1 sided|||Week 7||||< 0.0001
72502363|NCT00500071|144535348|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||t-test, 1 sided|||||||< 0.0001
72502364|NCT00500071|144535351|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||t-test, 1 sided|||||||< 0.0001
72502365|NCT00500071|144535352|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||t-test, 1 sided|||Global Executive Composite||||< 0.0001
72502366|NCT00500071|144535352|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||t-test, 1 sided|||Behavioral Recognition Index||||< 0.0001
72502367|NCT00500071|144535352|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||t-test, 1 sided|||Metacognition Index||||< 0.0001
72502368|NCT03182738|144535391|SUPERIORITY|"Linear mixed models to test difference in mean neuropathy score from period 1 to period 2 between the two arms."|Difference in Change|-0.32||||0.02|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in neuropathy score from period 1 to period 2 between the two arms.~Negative estimation parameter value indicates intervention arm better than control arm."|"The null hypothesis is that there is no difference in change in mean neuropathy score from period 1 to period 2 between the two arms"||||0.02
72463992|NCT03544229|144450673|SUPERIORITY||Least Square Mean Difference|0.08|STANDARD_ERROR_OF_MEAN|0.25|=|0.618|TWO_SIDED|90.0|-0.34|0.49||1-sided p-values were obtained using MMRM Model. It was based on the one-sided alternative hypothesis testing that the treatment difference (TAK-906 - Placebo) in ANMS GCSI-DD composite score was \<0.|MMRM||MMRM included week, treatment, participant disease population (DG/IG), treatment-by-week interaction as fixed effects, baseline and baseline score-by-week interaction as covariates, with an unstructured working covariance matrix as default.|||0.49|-0.34|=0.618
72463993|NCT03544229|144450673|SUPERIORITY||Least Square Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.17|=|0.533|TWO_SIDED|90.0|-0.27|0.29||1-sided p-values were obtained using MMRM Model. It was based on the one-sided alternative hypothesis testing that the treatment difference (TAK-906 - Placebo) in ANMS GCSI-DD composite score was \<0.|MMRM||MMRM model included week, treatment, participant disease population (DG/IG), treatment-by-week interaction as fixed effects, baseline and baseline score-by-week interaction as covariates, with an unstructured working covariance matrix as default.|||0.29|-0.27|=0.533
72463994|NCT03544229|144450673|SUPERIORITY||Least Square Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.167|=|0.447|TWO_SIDED|90.0|-0.3|0.25||1-sided p-values were obtained using MMRM Model. It was based on the one-sided alternative hypothesis testing that the treatment difference (TAK-906 - Placebo) in ANMS GCSI-DD composite score was \<0.|MMRM||MMRM model included week, treatment, participant disease population (DG/IG), treatment-by-week interaction as fixed effects, baseline and baseline score-by-week interaction as covariates, with an unstructured working covariance matrix as default.|||0.25|-0.30|=0.447
72463995|NCT03544229|144450674|SUPERIORITY||Odds Ratio (OR)|0.87|||=|0.607|TWO_SIDED|90.0|0.39|1.96|||Logistic Regression||Comparisons of TAK-906 to Placebo was based on logistic regression with at least 50% reduction of participants from baseline in weekly composite score with baseline composite score, disease population at randomization, and treatment as covariates.|||1.96|0.39|=0.607
72463996|NCT03544229|144450674|SUPERIORITY||Odds Ratio (OR)|1.21|||=|0.283|TWO_SIDED|90.0|0.7|2.1|||Logistic Regression||Comparisons of TAK-906 to Placebo was based on logistic regression with at least 50% reduction of participants from baseline in weekly composite score with baseline composite score, disease population at randomization, and treatment as covariates.|||2.10|0.70|=0.283
72463997|NCT03544229|144450674|SUPERIORITY||Odds Ratio (OR)|0.98|||=|0.527|TWO_SIDED|90.0|0.56|1.69|||Logistic Regression||Comparisons of TAK-906 to Placebo was based on logistic regression with at least 50% reduction of participants from baseline in weekly composite score with baseline composite score, disease population at randomization, and treatment as covariates.|||1.69|0.56|=0.527
72502369|NCT03182738|144535391|SUPERIORITY|"Linear mixed models to test difference in mean problems maintaining an erection score from period 1 to period 2 between the two arms."|Difference in Change|-0.29||||0.11|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in problems maintaining an erection score from period 1 to period 2 between the two arms.~Negative estimation parameter value indicates intervention arm better than control arm."|"The null hypothesis is that there is no difference in change in mean problems maintaining an erection score from period 1 to period 2 between the two arms"||||0.11
72502370|NCT03182738|144535391|SUPERIORITY|"Linear mixed models to test difference in mean dry mouth score from period 1 to period 2 between the two arms."|Difference in Change|-0.29||||0.02|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in dry mouth score from period 1 to period 2 between the two arms.~Negative estimation parameter value indicates intervention arm better than control arm."|"The null hypothesis is that there is no difference in change in mean dry mouth score from period 1 to period 2 between the two arms"||||0.02
72502371|NCT03182738|144535391|SUPERIORITY|"Linear mixed models to test difference in mean ringing in ear score from period 1 to period 2 between the two arms."|Difference in Change|-0.29||||0.01|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in ringing in ear score from period 1 to period 2 between the two arms.~Negative estimation parameter value indicates intervention arm better than control arm."|"The null hypothesis is that there is no difference in change in mean ringing in ear score from period 1 to period 2 between the two arms"||||0.01
72502372|NCT03182738|144535391|SUPERIORITY|"Linear mixed models to test difference in mean vomit score from period 1 to period 2 between the two arms."|Difference in Change|-0.28||||0.01|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in vomit score from period 1 to period 2 between the two arms.~Negative estimation parameter value indicates intervention arm better than control arm."|"The null hypothesis is that there is no difference in change in mean vomit score from period 1 to period 2 between the two arms"||||0.01
72502373|NCT03182738|144535391|SUPERIORITY|"Linear mixed models to test difference in mean dry eyes score from period 1 to period 2 between the two arms."|Difference in Change|-0.24||||0.02|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in dry eyes score from period 1 to period 2 between the two arms.~Negative estimation parameter value indicates intervention arm better than control arm."|"The null hypothesis is that there is no difference in change in mean dry eyes score from period 1 to period 2 between the two arms"||||0.02
72563891|NCT02285634|144659112|SUPERIORITY|||||||0.61|||||||Fisher Exact|||||||0.61
72563892|NCT02285634|144659112|SUPERIORITY|||||||0.78|||||||Fisher Exact|||||||0.78
72563893|NCT02285634|144659113|SUPERIORITY|||||||0.27|||||||Fisher Exact|||||||0.27
72563894|NCT02285634|144659113|SUPERIORITY|||||||0.17|||||||Fisher Exact|||||||0.17
72563895|NCT02285634|144659113|SUPERIORITY|||||||0.56|||||||Fisher Exact|||||||0.56
72563896|NCT02285634|144659114|SUPERIORITY|||||||0.78|||||||Fisher Exact|||||||0.78
72563897|NCT02285634|144659114|SUPERIORITY|||||||0.1|||||||Fisher Exact|||||||0.10
72563898|NCT02285634|144659114|SUPERIORITY|||||||0.47|||||||Fisher Exact|||||||0.47
72463998|NCT03544229|144450675|SUPERIORITY||Least-Squares Mean Difference|0.06|STANDARD_ERROR_OF_MEAN|0.279|=|0.584|TWO_SIDED|90.0|-0.4|0.52||1-sided p-values were obtained using MMRM Model. It was based on the one-sided alternative hypothesis testing that the treatment difference (TAK-906 - Placebo) in ANMS GCSI-DD nausea symptom score was \<0.|MMRM||MMRM model included week, treatment, participant disease population (DG/IG), treatment-by-week interaction as fixed effects, baseline and baseline score-by-week interaction as covariates, with an unstructured working covariance matrix as default.|||0.52|-0.40|=0.584
72463999|NCT03544229|144450675|SUPERIORITY||Least-Squares Mean Difference|0.06|STANDARD_ERROR_OF_MEAN|0.189|=|0.625|TWO_SIDED|90.0|-0.25|0.37||1-sided p-values were obtained using MMRM Model. It was based on the one-sided alternative hypothesis testing that the treatment difference (TAK-906 - Placebo) in ANMS GCSI-DD nausea symptom score was \<0.|MMRM||MMRM model included week, treatment, participant disease population (DG/IG), treatment-by-week interaction as fixed effects, baseline and baseline score-by-week interaction as covariates, with an unstructured working covariance matrix as default.|||0.37|-0.25|=0.625
72464000|NCT03544229|144450675|SUPERIORITY||Least-Squares Mean Difference|0.02|STANDARD_ERROR_OF_MEAN|0.187|=|0.54|TWO_SIDED|90.0|-0.29|0.33||1-sided p-values were obtained using MMRM Model. It was based on the one-sided alternative hypothesis testing that the treatment difference (TAK-906 - Placebo) in ANMS GCSI-DD nausea symptom score was \<0.|MMRM||MMRM model included week, treatment, participant disease population (DG/IG), treatment-by-week interaction as fixed effects, baseline and baseline score-by-week interaction as covariates, with an unstructured working covariance matrix as default.|||0.33|-0.29|=0.540
72464001|NCT03544229|144450676|SUPERIORITY||Least-Squares Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.283|=|0.51|TWO_SIDED|90.0|-0.46|0.47||1-sided p-values were obtained using MMRM Model. It was based on the one-sided alternative hypothesis testing that the treatment difference (TAK-906 - Placebo) in ANMS GCSI-DD early satiety symptom score was \<0.|MMRM||MMRM model included week, treatment, participant disease population (DG/IG), treatment-by-week interaction as fixed effects, baseline and baseline score-by-week interaction as covariates, with an unstructured working covariance matrix as default.|||0.47|-0.46|=0.510
72464002|NCT03544229|144450676|SUPERIORITY||Least-Squares Mean Difference|0.09|STANDARD_ERROR_OF_MEAN|0.192|=|0.674|TWO_SIDED|90.0|-0.23|0.4||1-sided p-values were obtained using MMRM Model. It was based on the one-sided alternative hypothesis testing that the treatment difference (TAK-906 - Placebo) in ANMS GCSI-DD early satiety symptom score was \<0.|MMRM||MMRM model included week, treatment, participant disease population (DG/IG), treatment-by-week interaction as fixed effects, baseline and baseline score-by-week interaction as covariates, with an unstructured working covariance matrix as default.|||0.40|-0.23|=0.674
72464003|NCT03544229|144450676|SUPERIORITY||Least-Squares Mean Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.189|=|0.367|TWO_SIDED|90.0|-0.38|0.25||1-sided p-values were obtained using MMRM Model. It was based on the one-sided alternative hypothesis testing that the treatment difference (TAK-906 - Placebo) in ANMS GCSI-DD early satiety symptom score was \<0.|MMRM||MMRM model included week, treatment, participant disease population (DG/IG), treatment-by-week interaction as fixed effects, baseline and baseline score-by-week interaction as covariates, with an unstructured working covariance matrix as default.|||0.25|-0.38|=0.367
72464004|NCT03544229|144450677|SUPERIORITY||Least-Squares Mean Difference|0.06|STANDARD_ERROR_OF_MEAN|0.289|=|0.587|TWO_SIDED|90.0|-0.41|0.54||1-sided p-values were obtained using MMRM Model. It was based on the one-sided alternative hypothesis testing that the treatment difference (TAK-906 - Placebo) in ANMS GCSI-DD postprandial fullness symptom score was \<0.|MMRM||MMRM model included week, treatment, participant disease population (DG/IG), treatment-by-week interaction as fixed effects, baseline and baseline score-by-week interaction as covariates, with an unstructured working covariance matrix as default.|||0.54|-0.41|=0.587
72464005|NCT03544229|144450677|SUPERIORITY||Least-Squares Mean Difference|0.05|STANDARD_ERROR_OF_MEAN|0.196|=|0.6|TWO_SIDED|90.0|-0.27|0.37||1-sided p-values were obtained using MMRM Model. It was based on the one-sided alternative hypothesis testing that the treatment difference (TAK-906 - Placebo) in ANMS GCSI-DD postprandial fullness symptom score was \<0.|MMRM||MMRM model included week, treatment, participant disease population (DG/IG), treatment-by-week interaction as fixed effects, baseline and baseline score-by-week interaction as covariates, with an unstructured working covariance matrix as default.|||0.37|-0.27|=0.600
72464006|NCT03544229|144450677|SUPERIORITY||Least-Squares Mean Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.193|=|0.446|TWO_SIDED|90.0|-0.34|0.29||1-sided p-values were obtained using MMRM Model. It was based on the one-sided alternative hypothesis testing that the treatment difference (TAK-906 - Placebo) in ANMS GCSI-DD postprandial fullness symptom score was \<0.|MMRM||MMRM model included week, treatment, participant disease population (DG/IG), treatment-by-week interaction as fixed effects, baseline and baseline score-by-week interaction as covariates, with an unstructured working covariance matrix as default.|||0.29|-0.34|=0.446
72464007|NCT03544229|144450678|SUPERIORITY||Least-Squares Mean Difference|0.04|STANDARD_ERROR_OF_MEAN|0.245|=|0.562|TWO_SIDED|90.0|-0.37|0.44||1-sided p-values were obtained using MMRM Model. It was based on the one-sided alternative hypothesis testing that the treatment difference (TAK-906 - Placebo) in ANMS GCSI-DD upper abdominal pain symptom score was \<0.|MMRM||MMRM model included week, treatment, participant disease population (DG/IG), treatment-by-week interaction as fixed effects, baseline and baseline score-by-week interaction as covariates, with an unstructured working covariance matrix as default.|||0.44|-0.37|=0.562
72563899|NCT00880087|144659125|SUPERIORITY||Risk Difference (RD)|-2.6||||0.63|TWO_SIDED|95.0|-14.5|9.2|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test was used adjusting for age category at time of randomization (\<2 years, 2 to \<12 years, or \>=12 years)||||9.2|-14.5|0.63
72464008|NCT03544229|144450678|SUPERIORITY||Least-Squares Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.166|=|0.138|TWO_SIDED|90.0|-0.46|0.09||1-sided p-values were obtained using MMRM Model. It was based on the one-sided alternative hypothesis testing that the treatment difference (TAK-906 - Placebo) in ANMS GCSI-DD upper abdominal pain symptom score was \<0.|MMRM||MMRM model included week, treatment, participant disease population (DG/IG), treatment-by-week interaction as fixed effects, baseline and baseline score-by-week interaction as covariates, with an unstructured working covariance matrix as default.|||0.09|-0.46|=0.138
72563900|NCT00880087|144659126|SUPERIORITY||Risk Difference (RD)|2.8||||0.56|TWO_SIDED|95.0|-8.0|13.7|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test was used adjusting for age category at time of randomization (\<2 years, 2 to \<12 years, or \>=12 years)||||13.7|-8.0|0.56
72464009|NCT03544229|144450678|SUPERIORITY||Least-Squares Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.164|=|0.394|TWO_SIDED|90.0|-0.32|0.23||1-sided p-values were obtained using MMRM Model. It was based on the one-sided alternative hypothesis testing that the treatment difference (TAK-906 - Placebo) in ANMS GCSI-DD upper abdominal pain symptom score was \<0.|MMRM||MMRM model included week, treatment, participant disease population (DG/IG), treatment-by-week interaction as fixed effects, baseline and baseline score-by-week interaction as covariates, with an unstructured working covariance matrix as default.|||0.23|-0.32|=0.394
72464010|NCT03544229|144450679|SUPERIORITY||Least-Squares Mean Difference|0.27|STANDARD_ERROR_OF_MEAN|0.484|=|0.709|TWO_SIDED|90.0|-0.53|1.07||1-sided p-values were obtained using MMRM Model. It was based on the one-sided alternative hypothesis testing that the treatment difference (TAK-906 - Placebo) in ANMS GCSI-DD recorded vomiting frequency was \<0.|MMRM||MMRM model included week, treatment, participant disease population (DG/IG), treatment-by-week interaction as fixed effects, baseline and baseline score-by-week interaction as covariates, with an unstructured working covariance matrix as default.|||1.07|-0.53|=0.709
72464011|NCT03544229|144450679|SUPERIORITY||Least-Squares Mean Difference|0.24|STANDARD_ERROR_OF_MEAN|0.332|=|0.76|TWO_SIDED|90.0|-0.31|0.78||1-sided p-values were obtained using MMRM Model. It was based on the one-sided alternative hypothesis testing that the treatment difference (TAK-906 - Placebo) in ANMS GCSI-DD recorded vomiting frequency was \<0.|MMRM||MMRM model included week, treatment, participant disease population (DG/IG), treatment-by-week interaction as fixed effects, baseline and baseline score-by-week interaction as covariates, with an unstructured working covariance matrix as default.|||0.78|-0.31|=0.760
72464012|NCT03544229|144450679|SUPERIORITY||Least-Squares Mean Difference|0.08|STANDARD_ERROR_OF_MEAN|0.33|=|0.591|TWO_SIDED|90.0|-0.47|0.62||1-sided p-values were obtained using MMRM Model. It was based on the one-sided alternative hypothesis testing that the treatment difference (TAK-906 - Placebo) in ANMS GCSI-DD recorded vomiting frequency was \<0.|MMRM||MMRM model included week, treatment, participant disease population (DG/IG), treatment-by-week interaction as fixed effects, baseline and baseline score-by-week interaction as covariates, with an unstructured working covariance matrix as default.|||0.62|-0.47|=0.591
72464013|NCT03544229|144450680|SUPERIORITY||Least-Squares Mean Difference|0.18|STANDARD_ERROR_OF_MEAN|0.27|=|0.742|TWO_SIDED|90.0|-0.27|0.62||1-sided p-values were obtained using MMRM Model. It was based on the one-sided alternative hypothesis testing that the treatment difference (TAK-906 - Placebo) in ANMS GCSI-DD overall severity of gastroparesis symptoms score was \<0.|MMRM||MMRM model included week, treatment, participant disease population (DG/IG), treatment-by-week interaction as fixed effects, baseline and baseline score-by-week interaction as covariates, with an unstructured working covariance matrix as default.|||0.62|-0.27|=0.742
72464014|NCT03544229|144450680|SUPERIORITY||Least-Squares Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.183|=|0.461|TWO_SIDED|90.0|-0.32|0.28||1-sided p-values were obtained using MMRM Model. It was based on the one-sided alternative hypothesis testing that the treatment difference (TAK-906 - Placebo) in ANMS GCSI-DD overall severity of gastroparesis symptoms score was \<0.|MMRM||MMRM model included week, treatment, participant disease population (DG/IG), treatment-by-week interaction as fixed effects, baseline and baseline score-by-week interaction as covariates, with an unstructured working covariance matrix as default.|||0.28|-0.32|=0.461
72504818|NCT03114969|144540518|SUPERIORITY||Odds Ratio (OR)|2.079||||0.086|TWO_SIDED|95.0|0.901|4.799||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta+\[Relvar Ellipta+LAMA\] as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.|||4.799|0.901|0.086
72621231|NCT02732145|144773187|EQUIVALENCE|Question: Is there a difference in the incidence of unintended weight loss among patients from different groups?||||||0.1764|||||||Chi-squared|||Parameter: The difference in the incidence of unintended weight loss among patients from different groups.||||0.1764
72621232|NCT02732145|144773187|EQUIVALENCE|Question: Is there a difference in the incidence of endometriosis among patients from different groups?||||||0.3127|||||||Chi-squared|||Parameter: The difference in the incidence of endometriosis among patients from different groups.||||0.3127
72621233|NCT02732145|144773187|EQUIVALENCE|"Question: Is there a difference in the incidence of D-D-D Triad among patients from different groups?"||||||0.0028|||||||Chi-squared|||"Parameter: The difference in the difference in the incidence of D-D-D Triad (Dysmenorrhoea-Dyspareunia-Dysuria) among patients from different groups."||||0.0028
72393938|NCT01059825|144294278|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.63||||0|TWO_SIDED|80.0|-0.8|-0.45||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p \<0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-0.45|-0.80|0.000
72504819|NCT03114969|144540518|SUPERIORITY||Odds Ratio (OR)|1.95||||0.082|TWO_SIDED|95.0|0.918|4.142||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta+\[Relvar Ellipta+LAMA\] as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.|||4.142|0.918|0.082
72504820|NCT03114969|144540518|SUPERIORITY||Odds Ratio (OR)|2.415||||0.018|TWO_SIDED|95.0|1.161|5.024||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta+\[Relvar Ellipta+LAMA\] as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.|||5.024|1.161|0.018
72464015|NCT03544229|144450680|SUPERIORITY||Least-Squares Mean Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.181|=|0.376|TWO_SIDED|90.0|-0.36|0.24||1-sided p-values were obtained using MMRM Model. It was based on the one-sided alternative hypothesis testing that the treatment difference (TAK-906 - Placebo) in ANMS GCSI-DD overall severity of gastroparesis symptoms score was \<0.|MMRM||MMRM model included week, treatment, participant disease population (DG/IG), treatment-by-week interaction as fixed effects, baseline and baseline score-by-week interaction as covariates, with an unstructured working covariance matrix as default.|||0.24|-0.36|=0.376
72464016|NCT03544229|144450681|SUPERIORITY||Least-Squares Mean Difference|0.07|STANDARD_ERROR_OF_MEAN|0.286|=|0.591|TWO_SIDED|90.0|-0.41|0.54||1-sided p-values were obtained using MMRM Model. It was based on the one-sided alternative hypothesis testing that the treatment difference (TAK-906 - Placebo) in ANMS GCSI-DD bloating severity scale score was \<0.|MMRM||MMRM model included week, treatment, participant disease population (DG/IG), treatment-by-week interaction as fixed effects, baseline and baseline score-by-week interaction as covariates, with an unstructured working covariance matrix as default.|||0.54|-0.41|=0.591
72464017|NCT03544229|144450681|SUPERIORITY||Least-Squares mean Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.193|=|0.291|TWO_SIDED|90.0|-0.43|0.21||1-sided p-values were obtained using MMRM Model. It was based on the one-sided alternative hypothesis testing that the treatment difference (TAK-906 - Placebo) in ANMS GCSI-DD bloating severity scale score was \<0.|MMRM||MMRM model included week, treatment, participant disease population (DG/IG), treatment-by-week interaction as fixed effects, baseline and baseline score-by-week interaction as covariates, with an unstructured working covariance matrix as default.|||0.21|-0.43|=0.291
72464018|NCT03544229|144450681|SUPERIORITY||Least-Squares Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.191|=|0.476|TWO_SIDED|90.0|-0.33|0.3||1-sided p-values were obtained using MMRM Model. It was based on the one-sided alternative hypothesis testing that the treatment difference (TAK-906 - Placebo) in ANMS GCSI-DD bloating severity scale score was \<0.|MMRM||MMRM model included week, treatment, participant disease population (DG/IG), treatment-by-week interaction as fixed effects, baseline and baseline score-by-week interaction as covariates, with an unstructured working covariance matrix as default.|||0.30|-0.33|=0.476
72464019|NCT03544229|144450682|SUPERIORITY||Least-Squares Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.224|=|0.675|TWO_SIDED|90.0|-0.27|0.47||1-sided p-values were obtained using MMRM Model. It was based on the one-sided alternative hypothesis testing that the treatment difference (TAK-906 - Placebo) in ANMS GCSI-DD total score was \<0.|MMRM||MMRM model included week, treatment, participant disease population (DG/IG), treatment-by-week interaction as fixed effects, baseline and baseline score-by-week interaction as covariates, with an unstructured working covariance matrix as default.|||0.47|-0.27|=0.675
72464020|NCT03544229|144450682|SUPERIORITY||Least-Squares Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.152|=|0.531|TWO_SIDED|90.0|-0.24|0.26||1-sided p-values were obtained using MMRM Model. It was based on the one-sided alternative hypothesis testing that the treatment difference (TAK-906 - Placebo) in ANMS GCSI-DD total score was \<0.|MMRM||MMRM model included week, treatment, participant disease population (DG/IG), treatment-by-week interaction as fixed effects, baseline and baseline score-by-week interaction as covariates, with an unstructured working covariance matrix as default.|||0.26|-0.24|=0.531
72464021|NCT03544229|144450682|SUPERIORITY||Least-Squares Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.15|=|0.473|TWO_SIDED|90.0|-0.26|0.24||1-sided p-values were obtained using MMRM Model. It was based on the one-sided alternative hypothesis testing that the treatment difference (TAK-906 - Placebo) in ANMS GCSI-DD total score was \<0.|MMRM||MMRM model included week, treatment, participant disease population (DG/IG), treatment-by-week interaction as fixed effects, baseline and baseline score-by-week interaction as covariates, with an unstructured working covariance matrix as default.|||0.24|-0.26|=0.473
72464022|NCT03544229|144450683|SUPERIORITY||Least-Squares Mean Difference|-8.47|STANDARD_ERROR_OF_MEAN|9.71|=|0.192|TWO_SIDED|90.0|-24.5|7.57||The 1-sided p-value was based on the one-sided alternative hypothesis testing that the treatment difference (TAK-906 -Placebo) in symptomatic weeks was \<0.|ANOVA|||||7.57|-24.50|=0.192
72464023|NCT03544229|144450683|SUPERIORITY||Least-Squares Mean Difference|-4.85|STANDARD_ERROR_OF_MEAN|6.736|=|0.236|TWO_SIDED|90.0|-15.98|6.27||The 1-sided p-value was based on the one-sided alternative hypothesis testing that the treatment difference (TAK-906 - Placebo) in symptomatic weeks was \<0.|ANOVA|||||6.27|-15.98|=0.236
72464024|NCT03544229|144450683|SUPERIORITY||Least-Squares Mean Difference|-3.58|STANDARD_ERROR_OF_MEAN|6.689|=|0.297|TWO_SIDED|90.0|-14.62|7.47||The 1-sided p-value was based on the one-sided alternative hypothesis testing that the treatment difference (TAK-906 - Placebo) in symptomatic weeks was \<0.|ANOVA|||||7.47|-14.62|=0.297
72464025|NCT03544229|144450684|SUPERIORITY||Least-Squares Mean Difference|0.08|STANDARD_ERROR_OF_MEAN|0.3|=|0.601|TWO_SIDED|90.0|-0.42|0.57||1-sided p-values were obtained using MMRM of PAGI-SYM total score. It was based on the one-sided alternative hypothesis testing that the treatment difference (TAK-906 - Placebo) in PAGI-SYM total score was \<0.|MMRM||MMRM model included week, treatment, participant disease population (DG/IG), treatment-by-week interaction as fixed effects, baseline and baseline score-by-week interaction as covariates, with an unstructured working covariance matrix as default.|||0.57|-0.42|=0.601
72563901|NCT00880087|144659127|SUPERIORITY|||||||0.7|||||||Stratified Mann-Whitney Test|Test stratified by age category (\<2 years, 2 to \<12 years, or \>=12 years), for continuous (NOT categorized as reported above) 1-year change in VABS-II|||As the (nonparametric) comparison treated 1-year deaths as worst possible outcomes and worst possible 1-year VABS-II as next worst possible outcomes, using change in VABS-II for other participants alive at 1 year, no relevant estimation of effect size is possible for this secondary outcome.|||0.70
72563902|NCT00880087|144659128|SUPERIORITY|||||||0.46|||||||Wilcoxon (Mann-Whitney)|"Test used the continuous (NOT categorized as reported above) neuropsychological scores, with Lowest Possible Score treated as lowest possible value."||||||0.46
72464026|NCT03544229|144450684|SUPERIORITY||Least-Squares Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.2|=|0.181|TWO_SIDED|90.0|-0.51|0.15||1-sided p-values were obtained using MMRM of PAGI-SYM total score. It was based on the one-sided alternative hypothesis testing that the treatment difference (TAK-906 - Placebo) in PAGI-SYM total score was \<0.|MMRM||MMRM model includes week, treatment, participant disease population (DG/IG), treatment-by-week interaction as fixed effects, baseline and baseline score-by-week interaction as covariates, with an unstructured working covariance matrix as default.|||0.15|-0.51|=0.181
72464027|NCT03544229|144450684|SUPERIORITY||Least-Squares Mean Diferrence|-0.24|STANDARD_ERROR_OF_MEAN|0.196|=|0.114|TWO_SIDED|90.0|-0.56|0.09||1-sided p-values were obtained using MMRM of PAGI-SYM total score. It was based on the one-sided alternative hypothesis testing that the treatment difference (TAK-906 - Placebo) in PAGI-SYM total score was \<0.|MMRM||MMRM model includes week, treatment, participant disease population (DG/IG), treatment-by-week interaction as fixed effects, baseline and baseline score-by-week interaction as covariates, with an unstructured working covariance matrix as default.|||0.09|-0.56|=0.114
72502374|NCT03182738|144535391|SUPERIORITY|"Linear mixed models to test difference in mean heartburn score from period 1 to period 2 between the two arms."|Difference in Change|-0.19||||0.11|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in heartburn score from period 1 to period 2 between the two arms.~Negative estimation parameter value indicates intervention arm better than control arm."|"The null hypothesis is that there is no difference in change in mean heartburn score from period 1 to period 2 between the two arms"||||0.11
72502375|NCT03182738|144535391|SUPERIORITY|"Linear mixed models to test difference in mean diarrhea score from period 1 to period 2 between the two arms."|Difference in Change|-0.16||||0.21|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in diarrhea score from period 1 to period 2 between the two arms.~Negative estimation parameter value indicates intervention arm better than control arm."|"The null hypothesis is that there is no difference in change in mean diarrhea score from period 1 to period 2 between the two arms"||||0.21
72502376|NCT03182738|144535391|SUPERIORITY|"Linear mixed models to test difference in mean constipation score from period 1 to period 2 between the two arms."|Difference in Change|-0.14||||0.33|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in constipation score from period 1 to period 2 between the two arms.~Negative estimation parameter value indicates intervention arm better than control arm."|"The null hypothesis is that there is no difference in change in mean constipation score from period 1 to period 2 between the two arms"||||0.33
72563903|NCT02973321|144659134|OTHER|The overall Type 1 error for multiple comparisons of the HbA1c and body weight was controlled by a Hierarchical testing procedure. Testing was performed in following sequence: 1. 1st trend test for HbA1c, 2. 1st trend test for body weight, 3. 2nd trend test for HbA1c, 4. 2nd trend test for body weight, 5. 3rd trend test for HbA1c, 6. 3rd trend test for body weight.|||||<|0.0001||||||Hierarchical testing procedure continued only, if the previous comparison was statistically significant. Threshold for significance at 0.05 level.|ANCOVA|1st trend test||Analysis was performed using analysis of covariance (ANCOVA) model with treatment groups, randomization strata of screening HbA1c value (\<8, \>=8 %), randomization strata of Visit 4 (Day 1) BMI (\<35.0 kg/m\^2, \>=35.0 kg/m\^2), and country as fixed effects and baseline HbA1c as a covariate. Overall 1st trend test based on a contrast with coefficients of +3, +1, -1, -3 and 0 for SAR425899 0.20 mg, 0.16 mg, 0.12 mg, placebo and liraglutide. Here it is test 1 of testing order.||||< 0.0001
72464028|NCT01951261|144450685|NON_INFERIORITY|sample size calculation was made, considering it appropriate to set a limit of non-inferiority with respect to the main variable of 1.2 months (36 days), the study being lower if it will have exacerbation before this period of time, with a follow-up of 6 months, It was required to include a sample of 58 patients per group for a potency of 80% and a significance level of 5%.|||||<|0.05||||||The reported p-value was calculated.Statistical analysis of the main variable was performed using the Kaplan-Meier method and log-rank test|Log Rank|||||||<0.05
72464029|NCT01954771|144450697|SUPERIORITY_OR_OTHER||Correlation coefficient|0.726|||<|0.001|TWO_SIDED||||||Correlation analysis|||The correlation study between HbA1c and MBG (mean blood glucose) from SMBG measurements.||||<0.001
72464030|NCT01954771|144450697|SUPERIORITY_OR_OTHER||Correlation coefficient|0.522||||0.004|TWO_SIDED||||||Correlation analysis|||The correlation study between HbA1c and MBG (mean blood glucose) from SMBG measurements.||||0.004
72464031|NCT01954771|144450697|SUPERIORITY_OR_OTHER||Correlation Coefficient|0.784|||<|0.001|TWO_SIDED||||||Correlation analysis|||The correlation study between HbA1c and MBG (mean blood glucose) from SMBG measurements.||||<0.001
72464032|NCT01954771|144450697|SUPERIORITY_OR_OTHER||Correlation Coefficient|0.533||||0.011|TWO_SIDED||||||Correlation analysis|||The correlation study between HbA1c and MBG (mean blood glucose) from CGMS measurements.||||0.011
72621234|NCT02732145|144773187|EQUIVALENCE|Question: Is there a difference in the incidence of hypertension among patients from different groups?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of hypertension among patients from different groups.||||0.0000
72621235|NCT02732145|144773187|EQUIVALENCE|Question: Is there a difference in the incidence of genital herpes among patients from different groups?||||||0.9323|||||||Chi-squared|||Parameter: The difference in the incidence of genital herpes among patients from different groups.||||0.9323
72464033|NCT01954771|144450697|SUPERIORITY_OR_OTHER||Correlation Coefficient|0.479||||0.009|TWO_SIDED||||||Correlation analysis|||The correlation study between HbA1c and MBG (mean blood glucose) from CGMS measurements.||||0.009
72464034|NCT01954771|144450697|SUPERIORITY_OR_OTHER||Correlation Coefficient|0.801|||<|0.001|TWO_SIDED||||||Correlation analysis|||The correlation study between HbA1c and MBG (mean blood glucose) from CGMS measurements.||||<0.001
72464035|NCT04098497|144450728|OTHER|||||||0.09|||||||t-test, 2 sided|t = 1.74, df = 28||baseline to day 42 comparison||||0.09
72464036|NCT04098497|144450729|OTHER|||||||0.09|||||||t-test, 2 sided|t = 1.75, df = 28||baseline to day 42||||0.09
72464037|NCT04098497|144450730|SUPERIORITY|||||||0.13|||||||Regression, Linear|β = 0.14, z = 1.51||Mean difference between receiving the intervention and not receiving the intervention at each time point.||||0.13
72464038|NCT04098497|144450731|SUPERIORITY|||||||0.007|||||||Regression, Linear|β = 0.38, z = 2.71||Mean difference between receiving the intervention and not receiving the intervention at each time point.||||0.007
72464039|NCT04098497|144450732|SUPERIORITY|||||||0.57|||||||Regression, Linear|β = 0.03, z = 0.58||Mean difference between receiving the intervention and not receiving the intervention at each time point.||||0.57
72464040|NCT04098497|144450733|SUPERIORITY|||||||0.25|||||||Regression, Linear|β = 0.06, z = 1.15||Mean difference between receiving the intervention and not receiving the intervention at each time point.||||0.25
72563904|NCT02973321|144659134|OTHER|Hierarchical testing procedure continued only, if the previous comparison was statistically significant.|LS Mean difference|-0.956|STANDARD_ERROR_OF_MEAN|0.206|<|0.0001|TWO_SIDED|95.0|-1.359|-0.552||Threshold for significance at 0.05 level.|ANCOVA|2nd Trend test||Analysis was performed using ANCOVA model with treatment groups, randomization strata of screening HbA1c value (\<8, \>=8 %), randomization strata of Visit 4 (Day 1) BMI (\<35.0 kg/m\^2, \>=35.0 kg/m\^2), and country as fixed effects and baseline HbA1c as a covariate. Second Trend test based on a contrast with coefficients of 0, +1, 0, -1 and 0 for SAR425899 0.20 mg, 0.16 mg, 0.12 mg, placebo and liraglutide, respectively. Here, it is test no. 3 of hierarchical testing sequence.||-0.552|-1.359|< 0.0001
72563905|NCT02973321|144659134|OTHER|Hierarchical testing procedure continued only, if the previous comparison was statistically significant.|LS Mean difference|-0.854|STANDARD_ERROR_OF_MEAN|0.209|<|0.0001|TWO_SIDED|95.0|-1.264|-0.444||Threshold for significance at 0.05 level.|ANCOVA|3rd Trend test||Analysis was performed using ANCOVA model with treatment groups, randomization strata of screening HbA1c value (\<8, \>=8 %), randomization strata of Visit 4 (Day 1) BMI (\<35.0 kg/m\^2, \>=35.0 kg/m\^2), and country as fixed effects and baseline HbA1c as a covariate. Third Trend test based on a contrast with coefficients of 0, 0, +1, -1 and 0 for SAR425899 0.20 mg, 0.16 mg, 0.12 mg, placebo and liraglutide, respectively. Here, it is test no. 5 of hierarchical testing sequence.||-0.444|-1.264|< 0.0001
72563906|NCT02973321|144659135|OTHER|Hierarchical testing procedure continued only, if the previous comparison was statistically significant.||||||0.0012||||||Threshold for significance at 0.05 level.|ANCOVA|1st Trend test||Placebo, SAR425899 0.12,0.16,0.20 mg: Analysis was performed using ANCOVA model with treatment groups, randomization strata of screening HbA1c value (\<8, \>=8 %), randomization strata of Day 1 BMI (\<35.0 kg/m\^2, \>=35.0 kg/m\^2), and country as fixed effects and baseline body weight as a covariate. Here, it is test no. 2 of hierarchical testing sequence.||||0.0012
72563907|NCT02973321|144659135|OTHER|Hierarchical testing procedure continued only, if the previous comparison was statistically significant|LS Mean difference|-3.57|STANDARD_ERROR_OF_MEAN|0.887|<|0.0001|TWO_SIDED|95.0|-5.309|-1.832||Threshold for significance at 0.05 level.|ANCOVA|2nd Trend test||SAR425899 0.16 mg vs Placebo: Analysis was performed using ANCOVA model with treatment groups, randomization strata of screening HbA1c value (\<8, \>=8 %), randomization strata of Day 1 BMI (\<35.0 kg/m\^2, \>=35.0 kg/m\^2), and country as fixed effects and baseline body weight as a covariate. Here, it is test no. 4 of hierarchical testing sequence.||-1.832|-5.309|< 0.0001
72621236|NCT02732145|144773187|EQUIVALENCE|Question: Is there a difference in the incidence of thyroid disease among patients from different groups?||||||0.0011|||||||Chi-squared|||Parameter: The difference in the incidence of thyroid disease among patients from different groups.||||0.0011
72464041|NCT00297778|144450734|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.9||||0.0103||95.0|-3.4|-0.5|||ANCOVA|||||-0.5|-3.4|0.0103
72502377|NCT03182738|144535391|SUPERIORITY|"Linear mixed models to test difference in mean appetite change score from period 1 to period 2 between the two arms."|Difference in Change|-0.1||||0.46|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in appetite change score from period 1 to period 2 between the two arms.~Negative estimation parameter value indicates intervention arm better than control arm."|"The null hypothesis is that there is no difference in change in mean appetite change score from period 1 to period 2 between the two arms"||||0.46
72502378|NCT03182738|144535391|SUPERIORITY|"Linear mixed models to test difference in mean difficulty remembering score from period 1 to period 2 between the two arms."|Difference in Change|-0.1||||0.46|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in difficulty remembering score from period 1 to period 2 between the two arms.~Negative estimation parameter value indicates intervention arm better than control arm."|"The null hypothesis is that there is no difference in change in mean difficulty remembering score from period 1 to period 2 between the two arms"||||0.46
72621237|NCT02732145|144773187|EQUIVALENCE|Question: Is there a difference in the incidence of drug allergy among patients from different groups?||||||0.2756|||||||Chi-squared|||Parameter: The difference in the incidence of drug allergy among patients from different groups.||||0.2756
72464042|NCT00297778|144450735|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.758||||0.0535||95.0|0.992|3.115|||Regression, Logistic|||||3.115|0.992|0.0535
72464043|NCT00297778|144450736|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.8||||0.0346||95.0|-1.5|-0.1|||ANCOVA|||||-0.1|-1.5|0.0346
72464044|NCT00297778|144450737|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0||||0.5244||95.0|-1.0|0.0|||Wilcoxon (Mann-Whitney)|||||0|-1|0.5244
72464045|NCT00297778|144450738|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.0||||0.141||95.0|0.0|0.0|||van Elteren (country stratification)|||||0|0|0.141
72464046|NCT00297778|144450739|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.2||||0.003||95.0|-1.9|-0.4|||ANCOVA|||||-0.4|-1.9|0.003
72464047|NCT00297778|144450740|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.2||||0.0034||95.0|-3.7|-0.7|||ANCOVA|||||-0.7|-3.7|0.0034
72464048|NCT00297778|144450741|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.4||||0.0007||95.0|-5.4|-1.5|||ANCOVA|||||-1.5|-5.4|0.0007
72464049|NCT00297778|144450742|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.821||||0.006||95.0|1.187|2.794|||Regression, Logistic|||||2.794|1.187|0.006
72464050|NCT00297778|144450743|SUPERIORITY_OR_OTHER||Median Difference (Net)|-1.3||||0.1925||95.0|-3.3|0.8|||van Elteren (country stratification)|||||0.8|-3.3|0.1925
72464051|NCT00297778|144450744|SUPERIORITY_OR_OTHER||Hodges-Lehmann est of diff in medians|0.04||||0.0337||95.0|0.0|0.09|||Wilcoxon rank sum (Van Elteren's test)|||||0.09|0|0.0337
72464052|NCT00297778|144450745|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.5||||0.8471||95.0|-5.6|4.6|||ANCOVA|||||4.6|-5.6|0.8471
72464053|NCT00297778|144450746|SUPERIORITY_OR_OTHER||Hodges-Lehmann est of diff in medians|0.0||||0.141|TWO_SIDED|95.0|0.0|0.0|||Wilcoxon rank sum (Van Elteren's test)||95% Confidence interval is Distribution-free Confidence Interval (Moses).|N's exclude patients from the analysis set with incomplete data||0.0|0.0|0.1410
72464054|NCT00297778|144450747|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1|STANDARD_ERROR_OF_MEAN|0.2||0.5231|TWO_SIDED|95.0|-0.5|0.2|||ANCOVA|||N's exclude patients from the analysis set with incomplete data||0.2|-0.5|0.5231
72464055|NCT03280108|144450750|NON_INFERIORITY|Non-inferiority based on the observed 95% Upper Confidence Limit of the difference in Least Squares Means (LSM) between the 2 groups (TFNT00 - SN60AT). Non-inferiority margin = 0.10 logMAR.|Least Squares Mean Difference|0.024|STANDARD_ERROR_OF_MEAN|0.0103|||ONE_SIDED|95.0||0.041||||||||0.041||
72464056|NCT03280108|144450751|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
72563908|NCT02973321|144659135|OTHER|Hierarchical testing procedure continued only, if the previous comparison was statistically significant.|LS Mean difference|-2.517|STANDARD_ERROR_OF_MEAN|0.891||0.0047|TWO_SIDED|95.0|-4.264|-0.77||Threshold for significance at 0.05 level.|ANCOVA|3rd Trend test||3rd Trend Test: SAR425899 0.12 mg vs Placebo: Analysis was performed using ANCOVA model with treatment groups, randomization strata of screening HbA1c value (\<8, \>=8 %), randomization strata of Day 1 BMI (\<35.0 kg/m\^2, \>=35.0 kg/m\^2), and country as fixed effects and baseline body weight as a covariate. Here, it is test no. 6 of hierarchical testing sequence.||-0.77|-4.264|0.0047
72563909|NCT00983476|144659238|SUPERIORITY_OR_OTHER||Slope|2.2||||0.11|TWO_SIDED||||||Mixed Models Analysis||Reference group is Web-based MOVE SMI: In-person MOVE SMI visit x group Beta estimate is .27 (p=.08); Reference group is Web-based MOVE SMI: Usual care plus handouts visit x group Beta estimate is .29 (p=.06).|Difference in Body Mass Index (BMI) by study arm at 6 months after controlling for BMI 6 months prior to baseline using a repeated measures mixed model with arm, time, and the interaction of arm by time||||0.11
72621238|NCT02732145|144773187|EQUIVALENCE|Question: Is there a difference in the incidence of recurrent attacks of sinusitis among patients from different groups?||||||0.0105|||||||Chi-squared|||Parameter: The difference in the incidence of recurrent attacks of sinusitis among patients from different groups.||||0.0105
72621239|NCT02732145|144773187|EQUIVALENCE|Question: Is there a difference in the incidence of HPV infection among patients from different groups, who were tested for HPV?||||||0.2128|||||||Chi-squared|||Parameter: The difference in the incidence of HPV infection among patients from different groups, who were tested for HPV.||||0.2128
72464057|NCT03280108|144450757|SUPERIORITY||Least Squares Mean Difference|-0.257|STANDARD_ERROR_OF_MEAN|0.0153|<|0.001|TWO_SIDED|95.0|-0.287|-0.227|||Mixed Models Analysis|||||-0.227|-0.287|<0.001
72464058|NCT03280108|144450758|SUPERIORITY||Mantel-Haenszel common difference|71.2|||||TWO_SIDED|95.0|61.87|80.46||||||||80.46|61.87|
72464059|NCT02109107|144450789|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||t-test, 2 sided|t=21.33; df=53||||||<.0001
72502379|NCT03182738|144535391|SUPERIORITY|"Linear mixed models to test difference in mean fatigue score from period 1 to period 2 between the two arms."|Difference in Change|-0.07||||0.58|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in fatigue score from period 1 to period 2 between the two arms.~Negative estimation parameter value indicates intervention arm better than control arm."|"The null hypothesis is that there is no difference in change in mean fatigue score from period 1 to period 2 between the two arms"||||0.58
72502380|NCT03182738|144535391|SUPERIORITY|"Linear mixed models to test difference in mean cough score from period 1 to period 2 between the two arms."|Difference in Change|0.01||||0.92|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in cough score from period 1 to period 2 between the two arms."|"The null hypothesis is that there is no difference in change in mean cough score from period 1 to period 2 between the two arms"||||0.92
72502381|NCT03182738|144535391|SUPERIORITY|"Linear mixed models to test difference in mean urination score from period 1 to period 2 between the two arms."|Difference in Change|0.02||||0.84|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in urination score from period 1 to period 2 between the two arms."|"The null hypothesis is that there is no difference in change in mean urination score from period 1 to period 2 between the two arms"||||0.84
72563910|NCT00983476|144659239|SUPERIORITY_OR_OTHER||Slope|4.02||||0.02|TWO_SIDED||||||Mixed Models Analysis||Reference group is Web-based MOVE SMI: In-person MOVE SMI visit x group Beta estimate is .40 (p=.02); Reference group is Web-based MOVE SMI: Usual care plus handouts visit x group Beta estimate is .44 (p=.01).|In the obese sample, difference in Body Mass Index (BMI) by study arm at 6 months after controlling for BMI 6 months prior to baseline using a repeated measures mixed model with arm, time, and the interaction of arm by time||||0.02
72464060|NCT02109107|144450790|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||t-test, 2 sided|t=2.95; df=53||||||<0.05
72464061|NCT02109107|144450791|SUPERIORITY_OR_OTHER||||||<|0.005|TWO_SIDED||||||t-test, 2 sided|t+3.34; df=53||||||<0.005
72464062|NCT00607789|144450800|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.3|STANDARD_DEVIATION|1.7|<|0.05|TWO_SIDED|95.0|||||t-test, 2 sided|||The primary efficacy analysis was a longitudinal analysis comparing the rate of change of binge day frequency during the treatment period between groups. The same analysis was applied to binge episode frequency, weight, BMI, and scores on the CGI-Severity, YBOCS-BE, and IDS scales. The difference in rate of change was estimated by random regression methods||||<0.05
72464063|NCT05401149|144450827|OTHER|Odds Ratio (OR) (95% CI) and P values for this outcome were derived from the conditional logistic regression models with stratification by matching pairs and adjustment for prior modified Rankin Scale (mRS) score (≤ 1 or not), baseline National Institutes of Health Stroke Scale (NIHSS) score, and time from symptom onset to hospital admission.|Odds Ratio (OR)|1.87|||<|0.001|TWO_SIDED|95.0|1.35|2.59|||Regression, Logistic||IV rt-PA cohort/Non-reperfusion cohort|||2.59|1.35|<0.001
72464064|NCT05401149|144450828|OTHER|OR (95% CI) and P values were derived from the conditional logistic regression models with stratification by matching pairs and adjustment for prior mRS score (≤ 1 or not), baseline NIHSS score, and time from symptom onset to hospital admission.|Odds Ratio (OR)|1.43||||0.054|TWO_SIDED|95.0|0.99|2.06|||Regression, Logistic||IV rt-PA cohort/Non-reperfusion cohort|||2.06|0.99|0.054
72464065|NCT05401149|144450829|OTHER|OR (95% CI) and P values were derived from the conditional logistic regression models with stratification by matching pairs and adjustment for prior mRS score (≤ 1 or not), baseline NIHSS score, and time from symptom onset to hospital admission.|Odds Ratio (OR)|2.07||||0.097|TWO_SIDED|95.0|0.88|4.86|||Regression, Logistic||IV rt-PA cohort/Non-reperfusion cohort|||4.86|0.88|0.097
72502382|NCT03182738|144535391|SUPERIORITY|"Linear mixed models to test difference in mean clumsy score from period 1 to period 2 between the two arms."|Difference in Change|0.03||||0.83|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in clumsy score from period 1 to period 2 between the two arms."|"The null hypothesis is that there is no difference in change in mean clumsy score from period 1 to period 2 between the two arms"||||0.83
72502383|NCT03182738|144535391|SUPERIORITY|"Linear mixed models to test difference in mean fever score from period 1 to period 2 between the two arms."|Difference in Change|0.04||||0.72|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in fever score from period 1 to period 2 between the two arms."|"The null hypothesis is that there is no difference in change in mean fever score from period 1 to period 2 between the two arms"||||0.72
72393939|NCT01059825|144294278|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.65||||0|TWO_SIDED|80.0|-0.82|-0.47||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p \<0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-0.47|-0.82|0.000
72464066|NCT05401149|144450830|OTHER|Odds Ratio (OR) (95% CI) and P values for this outcome were derived from the conditional logistic regression models with stratification by matching pairs and adjustment for prior modified Rankin Scale (mRS) score (≤ 1 or not), baseline National Institutes of Health Stroke Scale (NIHSS) score, and time from symptom onset to hospital admission.|Odds Ratio (OR)|2.02|||<|0.001|TWO_SIDED|95.0|1.48|2.75|||Regression, Logistic||IV rt-PA cohort/Non-reperfusion cohort|||2.75|1.48|<0.001
72464067|NCT05401149|144450831|OTHER|Odds Ratio (OR) (95% CI) and P values for this outcome were derived from the ordinal logistic regression models with adjustment for prior modified Rankin Scale (mRS) score (≤ 1 or not), baseline National Institutes of Health Stroke Scale (NIHSS) score, and time from symptom onset to hospital admission.|Odds Ratio (OR)|0.77||||0.007|TWO_SIDED|95.0|0.64|0.93|||Regression, Logistic||IV rt-PA cohort/Non-reperfusion cohort|||0.93|0.64|0.007
72464068|NCT05401149|144450832|OTHER|Hazard ratio (HR) (95% Confidence Interval) and P values were derived from the cox proportional hazards models with stratification by matching pairs and adjustment for prior mRS score (≤ 1 or not), baseline NIHSS score, and time from symptom onset to hospital admission.|Hazard Ratio (HR)|1.26||||0.077|TWO_SIDED|95.0|0.98|1.64|||Regression, Cox||IV rt-PA cohort/Non-reperfusion cohort|||1.64|0.98|0.077
72464069|NCT02264353|144450851|SUPERIORITY|||||||0.576|||||||t-test, 2 sided|||||||0.576
72464070|NCT02264353|144450852|OTHER|||||||0.394|||||||Wilcoxon (Mann-Whitney)|||||||0.394
72464071|NCT02264353|144450853|SUPERIORITY|||||||0.089|||||||t-test, 2 sided|||||||0.089
72464072|NCT02864147|144450857|SUPERIORITY|||||||0.043||||||Control is used as the referent using one-sided Fisher's exact tests with a multiple comparison-adjusted p\<0.025 significance level.|Fisher Exact|||||||0.043
72464073|NCT02864147|144450857|SUPERIORITY|||||||0.384||||||Control is used as the referent using one-sided Fisher's exact tests with a multiple comparison-adjusted p\<0.025 significance level.|Fisher Exact|||||||0.384
72563911|NCT00983476|144659240|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.14||||0.32|TWO_SIDED||||||ANOVA||No comparison between groups was conducted because overall model test was not statistically significant.|||||0.32
72563912|NCT00983476|144659241|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.23||||0.11|TWO_SIDED||||||ANOVA||No comparison between groups was conducted because overall model test was NS.|||||0.11
72563913|NCT00983476|144659242|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.75||||0.47|TWO_SIDED||||||ANOVA||No comparison between groups was conducted because overall model test was NS.|||||0.47
72393940|NCT01059825|144294278|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.67||||0|TWO_SIDED|80.0|-0.84|-0.5||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p \<0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-0.50|-0.84|0.000
72464074|NCT02864147|144450858|SUPERIORITY|||||||0.177||||||Control is used as the referent using one-sided Fisher's exact tests with a multiple comparison-adjusted p\<0.025 significance level.|Fisher Exact|||||||0.177
72464075|NCT02864147|144450858|SUPERIORITY|||||||0.592||||||Control is used as the referent using one-sided Fisher's exact tests with a multiple comparison-adjusted p\<0.025 significance level.|Fisher Exact|||||||0.592
72464076|NCT02269917|144450859|NON_INFERIORITY|4|Difference in percentage|0.4|||<|0.001|TWO_SIDED|95.0|-1.5|2.2|||Stratum-adjusted Mantel-Haenszel (MH)|||||2.2|-1.5|<0.001
72464077|NCT02269917|144450864|OTHER||Least Square (LS) Mean Difference|0.34|STANDARD_ERROR_OF_MEAN|0.623|=|0.58|TWO_SIDED|95.0|-0.88|1.57|||ANCOVA|||Change at Week 24||1.57|-0.88|=0.580
72464078|NCT02269917|144450864|OTHER||Least Square (LS) Mean Difference|0.62|STANDARD_ERROR_OF_MEAN|0.646|=|0.34|TWO_SIDED|95.0|-0.65|1.88|||ANCOVA|||Change at Week 48||1.88|-0.65|=0.340
72464079|NCT02269917|144450865|OTHER||LS Mean Difference|-0.58|STANDARD_ERROR_OF_MEAN|0.874|=|0.506|TWO_SIDED|95.0|-2.3|1.13|||ANCOVA|||Change at Week 24||1.13|-2.30|=0.506
72464080|NCT02269917|144450865|OTHER||LS Mean Difference|-0.74|STANDARD_ERROR_OF_MEAN|0.862|=|0.392|TWO_SIDED|95.0|-2.43|0.95|||ANCOVA|||Change Week 48||0.95|-2.43|=0.392
72464081|NCT02269917|144450866|OTHER||LS Mean Difference|-0.92|STANDARD_ERROR_OF_MEAN|0.624|=|0.143|TWO_SIDED|95.0|-2.14|0.31|||ANCOVA|||Change at Week 24||0.31|-2.14|=0.143
72464082|NCT02269917|144450866|OTHER||LS Mean Difference|-1.09|STANDARD_ERROR_OF_MEAN|0.646|=|0.092|TWO_SIDED|95.0|-2.36|0.18|||ANCOVA|||Change at Week 48||0.18|-2.36|=0.092
72464083|NCT02269917|144450867|OTHER||LS Mean Difference|1.14|STANDARD_ERROR_OF_MEAN|0.59|=|0.054|TWO_SIDED|95.0|-0.02|2.29|||ANCOVA|||Change at Week 24||2.29|-0.02|=0.054
72464084|NCT02269917|144450867|OTHER||LS Mean Difference|1.34|STANDARD_ERROR_OF_MEAN|0.63|=|0.034|TWO_SIDED|95.0|0.1|2.57|||ANCOVA|||Change at Week 48||2.57|0.10|=0.034
72464085|NCT02269917|144450868|OTHER||||||<|0.001|||||||Van Elteren Test|||UACR - Change at Week 24||||<0.001
72464086|NCT02269917|144450868|OTHER||||||<|0.001|||||||Van Elteren Test|||UACR - Change at Week 48||||<0.001
72464087|NCT02269917|144450868|OTHER||||||<|0.001|||||||Van Elteren Test|||UPCR - Change at Week 24||||<0.001
72464088|NCT02269917|144450868|OTHER||||||<|0.001|||||||Van Elteren Test|||UPCR - Change at Week 48||||<0.001
72464089|NCT02269917|144450869|OTHER||||||<|0.001|||||||Van Elteren Test|||URBPCR: Change at Week 24||||<0.001
72464090|NCT02269917|144450869|OTHER||||||<|0.001|||||||Van Elteren Test|||URBPCR: Change at Week 48||||<0.001
72464091|NCT02269917|144450869|OTHER||||||<|0.001|||||||Van Elteren Test|||UB2MGCR: Change at Week 24||||<0.001
72464092|NCT02269917|144450869|OTHER||||||<|0.001|||||||Van Elteren Test|||UB2MGCR: Change at Week 48||||<0.001
72464093|NCT02269917|144450870|OTHER||||||=|0.288|||||||Van Elteren Test|||FEPO4 - Change at Week 24||||=0.288
72464094|NCT02269917|144450870|OTHER||||||=|0.148|||||||Van Elteren Test|||FEPO4 - Change at Week 48||||=0.148
72464095|NCT02269917|144450881|OTHER||LS Mean Difference|1.37|STANDARD_ERROR_OF_MEAN|0.34|<|0.001|TWO_SIDED|95.0|0.697|2.037|||ANCOVA|||Spine BMD: Percent change at Week 24||2.037|0.697|<0.001
72464096|NCT02269917|144450881|OTHER||LS Mean Difference|2.05|STANDARD_ERROR_OF_MEAN|0.39|<|0.001|TWO_SIDED|95.0|1.277|2.814|||ANCOVA|||Spine BMD: Percent change at Week 48||2.814|1.277|<0.001
72464097|NCT02269917|144450881|OTHER||LS Mean Difference|0.9|STANDARD_ERROR_OF_MEAN|0.272|=|0.001|TWO_SIDED|95.0|0.366|1.436|||ANCOVA|||Hip BMD: Percent change at Week 24||1.436|0.366|=0.001
72464098|NCT02269917|144450881|OTHER||LS Mean Difference|1.7|STANDARD_ERROR_OF_MEAN|0.28|<|0.001|TWO_SIDED|95.0|1.144|2.248|||ANCOVA|||Hip BMD: Percent change at Week 48||2.248|1.144|<0.001
72464099|NCT01772147|144450929|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.127|||<|0.001|TWO_SIDED|95.0|0.089|0.164|||Mixed Models Analysis|||||0.164|0.089|<0.001
72464100|NCT01772147|144450929|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.148|||<|0.001|TWO_SIDED|95.0|0.111|0.185|||Mixed Models Analysis|||||0.185|0.111|<0.001
72464101|NCT04572997|144450942|OTHER||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|Wilcoxon Signed-rank test||||||< 0.0001
72464102|NCT04572997|144450947|OTHER||||||<|0.001|||||||Wilcoxon Signed-rank test|||||||< 0.001
72464103|NCT03443063|144450983|OTHER||Percent (%) ratio of geometric means|104.83|||||TWO_SIDED|90.0|77.41|141.97|||||"Percent ratio was calculated by dividing the geometric mean of reporting arm Lemborexant: Severe Renal Impairment by geometric mean of reporting arm Lemborexant: Normal Renal Function, then multiplying the value by 100."|||141.97|77.41|
72464104|NCT03443063|144450984|OTHER||Percent (%) ratio of geometric means|133.03|||||TWO_SIDED|90.0|107.3|164.93|||||"Percent ratio was calculated by dividing the geometric mean of reporting arm Lemborexant: Severe Renal Impairment by geometric mean of reporting arm Lemborexant: Normal Renal Function, then multiplying the value by 100."|||164.93|107.30|
72464105|NCT03443063|144450985|OTHER||Percent (%) ratio of geometric means|150.53|||||TWO_SIDED|90.0|113.16|200.26|||||"Percent ratio was calculated by dividing the geometric mean of reporting arm Lemborexant: Severe Renal Impairment by geometric mean of reporting arm Lemborexant: Normal Renal Function, then multiplying the value by 100."|||200.26|113.16|
72464106|NCT03443063|144450986|OTHER||Percent (%) ratio of geometric means|149.84|||||TWO_SIDED|90.0|113.06|198.58|||||"Percent ratio was calculated by dividing the geometric mean of reporting arm Lemborexant: Severe Renal Impairment by geometric mean of reporting arm Lemborexant: Normal Renal Function, then multiplying the value by 100."|||198.58|113.06|
72464107|NCT03443063|144450987|OTHER||Percent (%) ratio of geometric means|80.09|||||TWO_SIDED|90.0|56.07|114.4|||||"Percent ratio was calculated by dividing the geometric mean of reporting arm Lemborexant: Severe Renal Impairment by geometric mean of reporting arm Lemborexant: Normal Renal Function, then multiplying the value by 100."|Metabolite M4||114.40|56.07|
72464108|NCT03443063|144450987|OTHER||Percent (%) ratio of geometric means|79.51|||||TWO_SIDED|90.0|54.48|116.03|||||"Percent ratio was calculated by dividing the geometric mean of reporting arm Lemborexant: Severe Renal Impairment by geometric mean of reporting arm Lemborexant: Normal Renal Function, then multiplying the value by 100."|Metabolite M9||116.03|54.48|
72464109|NCT03443063|144450987|OTHER||Percent (%) ratio of geometric means|72.49|||||TWO_SIDED|90.0|48.08|109.29|||||"Percent ratio was calculated by dividing the geometric mean of reporting arm Lemborexant: Severe Renal Impairment by geometric mean of reporting arm Lemborexant: Normal Renal Function, then multiplying the value by 100."|Metabolite M10||109.29|48.08|
72464110|NCT03443063|144450989|OTHER||Percent (%) ratio of geometric mean|111.25|||||TWO_SIDED|90.0|91.69|134.99|||||"Percent ratio was calculated by dividing the geometric mean of reporting arm Lemborexant: Severe Renal Impairment by geometric mean of reporting arm Lemborexant: Normal Renal Function, then multiplying the value by 100."|Lemborexant||134.99|91.69|
72563914|NCT00983476|144659243|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.67||||0.51|TWO_SIDED||||||ANOVA||No comparison between groups was conducted because overall model test was NS.|||||0.51
72563915|NCT00983476|144659244|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.19||||0.83|TWO_SIDED||||||ANOVA||No comparison between groups was conducted because overall model test was NS.|||||0.83
72563916|NCT01175473|144659247|SUPERIORITY_OR_OTHER||Least squares (LS) Mean Difference|-154.42|||<|0.0001|TWO_SIDED|95.0|-180.3|-128.54||Linear fixed effects model with fixed terms for treatment, study site and GLU-AUC(0:30-4:30h) at baseline as covariate was used (using Statistical Analysis System \[SAS®\] PROC MIXED procedure).|Linear fixed effects model|No alpha adjustment was performed.||To detect a difference of 100 or 150 h\*mg/dL in change from baseline to Day 28 in GLU-AUC(0:30-4:30h) between lixisenatide and liraglutide, 60 patients per group would provide a power of 90% assuming common standard deviation of 170 or 250 h\*mg/dL, respectively, with a 2-sided test at 5% significance level.||-128.54|-180.30|<0.0001
72563917|NCT00588731|144659278|SUPERIORITY_OR_OTHER|||||||0.9|||||||ANOVA|||||||0.90
72563918|NCT00588731|144659279|SUPERIORITY_OR_OTHER|||||||0.76|||||||ANOVA|||||||0.76
72563919|NCT00346164|144659285|OTHER||||||<|0.0001|||||||Regression, Cox|||The Cox proportional hazards model was used to evaluate prognostic impact of disease extent (non-metastatic; metastatic) after accounting for the effects of site of the primary tumor (body wall; extremity; head/neck; visceral), tumor size (\<=5cm; \>5cm), tumor depth (deep; superficial), tumor invasiveness (invasive; non-invasive), extent of resection of the primary tumor (less than total resection; margin -; margin +), and histologic (POG) grade.||||<0.0001
72563920|NCT00346164|144659286|OTHER|||||||0.0049|||||||Regression, Cox|||The Cox proportional hazards model was used to evaluate prognostic impact of histologic (POG) grade after accounting for the effects of disease extent (non-metastatic; metastatic), site of the primary tumor (body wall; extremity; head/neck; visceral), tumor size (\<=5cm; \>5cm), tumor depth (deep; superficial), tumor invasiveness (invasive; non-invasive), and extent of resection of the primary tumor (less than total resection; margin -; margin +) .||||0.0049
72464111|NCT03443063|144450989|OTHER||Percent (%) ratio of geometric means|80.28|||||TWO_SIDED|90.0|56.81|113.46|||||"Percent ratio was calculated by dividing the geometric mean of reporting arm Lemborexant: Severe Renal Impairment by geometric mean of reporting arm Lemborexant: Normal Renal Function, then multiplying the value by 100."|Metabolite M4||113.46|56.81|
72464112|NCT03443063|144450989|OTHER||Percent (%) ratio of geometric means|86.71|||||TWO_SIDED|90.0|64.92|115.81|||||"Percent ratio was calculated by dividing the geometric mean of reporting arm Lemborexant: Severe Renal Impairment by geometric mean of reporting arm Lemborexant: Normal Renal Function, then multiplying the value by 100."|Metabolite M9||115.81|64.92|
72464113|NCT03443063|144450989|OTHER||Percent (%) ratio of geometric means|65.38|||||TWO_SIDED|90.0|41.08|104.04|||||"Percent ratio was calculated by dividing the geometric mean of reporting arm Lemborexant: Severe Renal Impairment by geometric mean of reporting arm Lemborexant: Normal Renal Function, then multiplying the value by 100."|Metabolite M10||104.04|41.08|
72464114|NCT03443063|144450990|OTHER||Percent (%) ratio of geometric means|114.69|||||TWO_SIDED|90.0|94.45|139.28|||||"Percent ratio was calculated by dividing the geometric mean of reporting arm Lemborexant: Severe Renal Impairment by geometric mean of reporting arm Lemborexant: Normal Renal Function, then multiplying the value by 100."|Metabolite M4||139.28|94.45|
72464115|NCT03443063|144450990|OTHER||Percent (%) ratio of geometric means|124.94|||||TWO_SIDED|90.0|100.27|155.67|||||"Percent ratio was calculated by dividing the geometric mean of reporting arm Lemborexant: Severe Renal Impairment by geometric mean of reporting arm Lemborexant: Normal Renal Function, then multiplying the value by 100."|Metabolite M9||155.67|100.27|
72464116|NCT03443063|144450990|OTHER||Percent (%) ratio of geometric means|92.05|||||TWO_SIDED|90.0|66.87|126.71|||||"Percent ratio was calculated by dividing the geometric mean of reporting arm Lemborexant: Severe Renal Impairment by geometric mean of reporting arm Lemborexant: Normal Renal Function, then multiplying the value by 100."|Metabolite M10||126.71|66.87|
72464117|NCT03443063|144450991|OTHER||Percent (%) ratio of geometric means|136.28|||||TWO_SIDED|90.0|105.62|175.85|||||"Percent ratio was calculated by dividing the geometric mean of reporting arm Lemborexant: Severe Renal Impairment by geometric mean of reporting arm Lemborexant: Normal Renal Function, then multiplying the value by 100."|Metabolite M4||175.85|105.62|
72464118|NCT03443063|144450991|OTHER||Percent (%) ratio of geometric means|154.29|||||TWO_SIDED|90.0|117.53|202.57|||||"Percent ratio was calculated by dividing the geometric mean of reporting arm Lemborexant: Severe Renal Impairment by geometric mean of reporting arm Lemborexant: Normal Renal Function, then multiplying the value by 100."|Metabolite M9||202.57|117.53|
72464119|NCT03443063|144450991|OTHER||Percent (%) ratio of geometric means|118.54|||||TWO_SIDED|90.0|87.84|159.97|||||"Percent ratio was calculated by dividing the geometric mean of reporting arm Lemborexant: Severe Renal Impairment by geometric mean of reporting arm Lemborexant: Normal Renal Function, then multiplying the value by 100."|Metabolite M10||159.97|87.84|
72464120|NCT03443063|144450992|OTHER||Percent (%) ratio of geometric means|138.62|||||TWO_SIDED|90.0|109.1|176.14|||||"Percent ratio was calculated by dividing the geometric mean of reporting arm Lemborexant: Severe Renal Impairment by geometric mean of reporting arm Lemborexant: Normal Renal Function, then multiplying the value by 100."|Metabolite M4||176.14|109.10|
72464121|NCT03443063|144450992|OTHER||Percent (%) ratio of geometric means|147.03|||||TWO_SIDED|90.0|109.06|198.22|||||"Percent ratio was calculated by dividing the geometric mean of reporting arm Lemborexant: Severe Renal Impairment by geometric mean of reporting arm Lemborexant: Normal Renal Function, then multiplying the value by 100."|Metabolite M9||198.22|109.06|
72464122|NCT03443063|144450992|OTHER||Percent (%) ratio of geometric means|136.42|||||TWO_SIDED|90.0|98.19|189.54|||||"Percent ratio was calculated by dividing the geometric mean of reporting arm Lemborexant: Severe Renal Impairment by geometric mean of reporting arm Lemborexant: Normal Renal Function, then multiplying the value by 100."|Metabolite M10||189.54|98.19|
72464123|NCT03443063|144450993|OTHER||Percent (%) ratio of geometric means|141.07|||||TWO_SIDED|90.0|103.79|191.73|||||"Percent ratio was calculated by dividing the geometric mean of reporting arm Lemborexant: Severe Renal Impairment by geometric mean of reporting arm Lemborexant: Normal Renal Function, then multiplying the value by 100."|Lemborexant||191.73|103.79|
72464124|NCT03443063|144450993|OTHER||Percent (%) ratio of geometric means|124.48|||||TWO_SIDED|90.0|100.58|154.06|||||"Percent ratio was calculated by dividing the geometric mean of reporting arm Lemborexant: Severe Renal Impairment by geometric mean of reporting arm Lemborexant: Normal Renal Function, then multiplying the value by 100."|Metabolite M4||154.06|100.58|
72464125|NCT03443063|144450993|OTHER||Percent (%) ratio of geometric means|143.31|||||TWO_SIDED|90.0|107.72|190.65|||||"Percent ratio was calculated by dividing the geometric mean of reporting arm Lemborexant: Severe Renal Impairment by geometric mean of reporting arm Lemborexant: Normal Renal Function, then multiplying the value by 100."|Metabolite M9||190.65|107.72|
72464126|NCT03443063|144450993|OTHER||Percent (%) ratio of geometric means|140.2|||||TWO_SIDED|90.0|98.11|200.35|||||"Percent ratio was calculated by dividing the geometric mean of reporting arm Lemborexant: Severe Renal Impairment by geometric mean of reporting arm Lemborexant: Normal Renal Function, then multiplying the value by 100."|Metabolite M10||200.35|98.11|
72464127|NCT00197106|144451031|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is considered to be shown if the upper limit of the one-sided 95% confidence interval of the difference uflixotide-useretide does not exceed +15% (uflixotide-useretide represent the mean percentages of asthma symptom-free days of the two respective treatment groups).|Adjusted difference|2.6||||0.63||95.0|-8.1|13.4|||Repeated Measurements Anal. of Variance|Anal. = Analysis||||13.4|-8.1|0.63
72464128|NCT01990313|144451053|SUPERIORITY|||||||0.038|||||||Mixed Models Analysis|||||||0.038
72563921|NCT00346164|144659287|OTHER||||||<|0.0001|||||||Regression, Cox|||The Cox proportional hazards model was used to evaluate prognostic impact of disease extent (non-metastatic; metastatic) after accounting for the effects of site of the primary tumor (body wall; extremity; head/neck; visceral), tumor size (\<=5cm; \>5cm), tumor depth (deep; superficial), tumor invasiveness (invasive; non-invasive), extent of resection of the primary tumor (less than total resection; margin -; margin +), and histologic (POG) grade.||||<0.0001
72563922|NCT00346164|144659288|OTHER|||||||0.0096|||||||Regression, Cox|||The Cox proportional hazards model was used to evaluate prognostic impact of the resection extent of the primary tumor (less than total resection; margin -; margin +) after accounting for the effects of site of the primary tumor (body wall; extremity; head/neck; visceral), disease extent (non-metastatic; metastatic), tumor size (\<=5cm; \>5cm), tumor depth (deep; superficial), tumor invasiveness (invasive; non-invasive), and histologic (POG) grade.||||0.0096
72563923|NCT00346164|144659289|OTHER||||||<|0.0001|||||||Regression, Logistic|Firth logistic regression is used to overcome the issue of quasi-complete separation of data points.||The logistic regression model was used to evaluate prognostic impact of disease extent (non-metastatic; metastatic) after accounting for the effects of site of the primary tumor (body wall; extremity; head/neck; visceral), tumor size (\<=5cm; \>5cm), tumor depth (deep; superficial), tumor invasiveness (invasive; non-invasive), extent of resection of the primary tumor (less than total resection; margin -; margin +), and histologic (POG) grade.||||<0.0001
72563924|NCT00346164|144659290|OTHER|||||||0.0228|||||||Regression, Logistic|Firth logistic regression is used to overcome the issue of quasi-complete separation of data points.||The logistic regression model was used to evaluate prognostic impact of histologic (POG) grade after accounting for the effects of disease extent (non-metastatic; metastatic), site of the primary tumor (body wall; extremity; head/neck; visceral), tumor size (\<=5cm; \>5cm), tumor depth (deep; superficial), tumor invasiveness (invasive; non-invasive), and extent of resection of the primary tumor (less than total resection; margin -; margin +) .||||0.0228
72563925|NCT00346164|144659292|OTHER||Kappa statistic|0.82|||||TWO_SIDED|95.0|0.76|0.88||||||Kappa statistic and its 95% confidence interval are used to assess agreement beyond random.||0.88|0.76|
72563926|NCT00346164|144659293|OTHER||Kappa statistic|0.42|||||TWO_SIDED|95.0|0.36|0.48||||||Kappa statistic and its 95% confidence interval are used to assess agreement beyond random.||0.48|0.36|
72563927|NCT01998243|144659305|SUPERIORITY||Risk Ratio (RR)|1.2||||0.689|TWO_SIDED|95.0|0.53|2.6|||Chi-squared||risk ratio (RR)|||2.60|0.53|0.689
72563928|NCT01998243|144659306|SUPERIORITY||Risk Ratio (RR)|1.59||||0.144|TWO_SIDED|95.0|0.84|3.01|||Chi-squared||all in all balloon and postsurgical morbidity in group A vs. group B.|||3.01|0.84|0.144
72621240|NCT02732145|144773187|EQUIVALENCE|Question: Is there a difference in the incidence of abnormal PAP smear among patients from different groups?||||||0.0018|||||||Chi-squared|||Parameter: The difference in the incidence of abnormal PAP smear among patients from different groups.||||0.0018
72621241|NCT02732145|144773187|EQUIVALENCE|Question: Is there a difference in the incidence of genital warts among patients from different groups?||||||0.2524|||||||Chi-squared|||Parameter: The difference in the incidence of genital warts among patients from different groups.||||0.2524
72621242|NCT02732145|144773187|EQUIVALENCE|Question: Is there a difference in the incidence of conization or LETZ among patients from different groups?||||||0.2452|||||||Chi-squared|||Parameter: The difference in the incidence of conization or LETZ among patients from different groups.||||0.2452
72621243|NCT02732145|144773188|SUPERIORITY|Question: Is there a difference in the frequency of any previous treatment between patients with vulvar dermatosis and vulvodynia?||||||0.1583|||||||Chi-squared|||Parameter: The difference in the frequency of any previous treatment between patients with vulvar dermatosis and vulvodynia.||||0.1583
72621244|NCT02732145|144773188|SUPERIORITY|Question: Is there a difference in the frequency of previous local treatment with antifungals between the patients with vulvar dermatosis and vulvodynia?||||||0.038|||||||Chi-squared|||Parameter: The difference in the frequency of previous local treatment with antifungals among patients with vulvar dermatosis and vulvodynia.||||0.0380
72621245|NCT02732145|144773188|SUPERIORITY|Question: Is there a difference in the frequency of previous systemic treatment with antifungals between the patients with vulvar dermatosis and vulvodynia?||||||0.6468|||||||Chi-squared|||Parameter: The difference in the frequency of previous systemic treatment with antifungals among patients with vulvar dermatosis and vulvodynia.||||0.6468
72621246|NCT02732145|144773188|SUPERIORITY|Question: Is there a difference in the frequency of previous local treatment with antibiotics between the patients with vulvar dermatosis and vulvodynia?||||||0.467|||||||Chi-squared|||Parameter: The difference in the frequency of previous local treatment with antibiotics among patients with vulvar dermatosis and vulvodynia.||||0.4670
72563929|NCT01998243|144659307|SUPERIORITY|||||||0.937|||||||Wilcoxon (Mann-Whitney)|||||||0.937
72563930|NCT01998243|144659308|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1
72563931|NCT01998243|144659309|SUPERIORITY|||||||0.673|||||||Fisher Exact|||||||0.673
72563932|NCT04569786|144659317|SUPERIORITY|A conclusion of superiority is based on the lower limit of the 90% CI for the estimated GMT ratio (V590/Placebo) being \>1.0 (one-sided p-value \<0.05).|GMT Ratio|0.92||||0.649|TWO_SIDED|90.0|0.63|1.34||1-sided|Longitudinal data analysis (LDA) method|GMT ratios and 90% CIs, and p-values are estimated from an LDA model and are provided in accordance with the statistical analysis plan.||||1.34|0.63|0.649
72563933|NCT04569786|144659317|SUPERIORITY|A conclusion of superiority is based on the lower limit of the 90% CI for the estimated GMT ratio (V590/Placebo) being \>1.0 (one-sided p-value \<0.05).|GMT Ratio|1.0||||0.495||90.0|0.68|1.48||1-sided|LDA model|GMT ratios and 90% CIs, and p-values are estimated from an LDA model and are provided in accordance with the statistical analysis plan.||||1.48|0.68|0.495
72563934|NCT04569786|144659317|SUPERIORITY|A conclusion of superiority is based on the lower limit of the 90% CI for the estimated GMT ratio (V590/Placebo) being \>1.0 (one-sided p-value \<0.05).|GMT Ratio|1.1||||0.339|TWO_SIDED|90.0|0.75|1.6||1-sided|LDA Model|GMT ratios and 90% CIs, and p-values are estimated from an LDA model and are provided in accordance with the statistical analysis plan.||||1.60|0.75|0.339
72563935|NCT04569786|144659317|SUPERIORITY|A conclusion of superiority is based on the lower limit of the 90% CI for the estimated GMT ratio (V590/Placebo) being \>1.0 (one-sided p-value \<0.05).|GMT Ratio|2.26|||<|0.001|TWO_SIDED|90.0|1.56|3.28||1-sided|LDA Model|GMT ratios and 90% CIs, and p-values are estimated from an LDA model and are provided in accordance with the statistical analysis plan.||||3.28|1.56|<0.001
72464129|NCT01907113|144451223|NON_INFERIORITY_OR_EQUIVALENCE|Ratio calculated as mild renal function divided by normal renal function|Geometric mean ratio|118.24|STANDARD_DEVIATION|25.6|||TWO_SIDED|90.0|96.17|145.38|||ANOVA|Based on ANOVA with fixed effect for treatment (corresponding to renal impairment status).|Standard deviation is actually the geometric Coefficient of Variation \[%\].|No formal testing, investigation of relative bioavailability||145.38|96.17|
72464130|NCT01907113|144451223|NON_INFERIORITY_OR_EQUIVALENCE|Ratio calculated as moderate renal function divided by normal renal function|Geometric mean ratio|119.94|STANDARD_DEVIATION|25.6|||TWO_SIDED|90.0|96.25|149.47|||ANOVA|Based on ANOVA with fixed effect for treatment (corresponding to renal impairment status).|Standard deviation is actually the geometric Coefficient of Variation \[%\].|No formal testing, investigation of relative bioavailability||149.47|96.25|
72464131|NCT01907113|144451223|NON_INFERIORITY_OR_EQUIVALENCE|Ratio calculated as severe renal function divided by normal renal function|Geometric mean ratio|166.29|STANDARD_DEVIATION|25.6|||TWO_SIDED|90.0|134.44|205.68|||ANOVA|Based on ANOVA with fixed effect for treatment (corresponding to renal impairment status).|Standard deviation is actually the geometric Coefficient of Variation \[%\].|No formal testing, investigation of relative bioavailability||205.68|134.44|
72464132|NCT01907113|144451223|NON_INFERIORITY_OR_EQUIVALENCE|Ratio calculated as kidney failure divided by normal renal function|Geometric mean ratio|148.29|STANDARD_DEVIATION|25.6|||TWO_SIDED|90.0|119.89|183.42|||ANOVA|Based on ANOVA with fixed effect for treatment (corresponding to renal impairment status).|Standard deviation is actually the geometric Coefficient of Variation \[%\].|No formal testing, investigation of relative bioavailability||183.42|119.89|
72464133|NCT01907113|144451224|NON_INFERIORITY_OR_EQUIVALENCE|Ratio calculated as mild renal function divided by normal renal function|Geometric mean ratio|118.83|STANDARD_DEVIATION|29.7|||TWO_SIDED|90.0|93.62|150.84|||ANOVA|Based on ANOVA with fixed effect for treatment (corresponding to renal impairment status).|Standard deviation is actually the geometric Coefficient of Variation \[%\].|No formal testing, investigation of relative bioavailability||150.84|93.62|
72464134|NCT01907113|144451224|NON_INFERIORITY_OR_EQUIVALENCE|Ratio calculated as moderate renal function divided by normal renal function|Geometric mean ratio|102.27|STANDARD_DEVIATION|29.7|||TWO_SIDED|90.0|79.33|131.85|||ANOVA|Based on ANOVA with fixed effect for treatment (corresponding to renal impairment status).|Standard deviation is actually the geometric Coefficient of Variation \[%\].|No formal testing, investigation of relative bioavailability||131.85|79.33|
72464135|NCT01907113|144451224|NON_INFERIORITY_OR_EQUIVALENCE|Ratio calculated as severe renal function divided by normal renal function|Geometric mean ratio|120.68|STANDARD_DEVIATION|29.7|||TWO_SIDED|90.0|94.42|154.25|||ANOVA|Based on ANOVA with fixed effect for treatment (corresponding to renal impairment status).|Standard deviation is actually the geometric Coefficient of Variation \[%\].|No formal testing, investigation of relative bioavailability||154.25|94.42|
72502384|NCT03182738|144535391|SUPERIORITY|"Linear mixed models to test difference in mean pain during sex score from period 1 to period 2 between the two arms."|Difference in Change|0.06||||0.48|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in pain during sex score from period 1 to period 2 between the two arms."|"The null hypothesis is that there is no difference in change in mean pain during sex score from period 1 to period 2 between the two arms"||||0.48
72502385|NCT03182738|144535391|SUPERIORITY|"Linear mixed models to test difference in mean dizziness score from period 1 to period 2 between the two arms."|Difference in Change|0.08||||0.54|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in dizziness score from period 1 to period 2 between the two arms."|"The null hypothesis is that there is no difference in change in mean dizziness score from period 1 to period 2 between the two arms"||||0.54
72563936|NCT00810888|144659331|SUPERIORITY|||||||1||||||not adjusted for multiple comparisons as a prior hypothesis critical value \<0.05|Fisher Exact|||Fisher's exact test||||1.00
72563937|NCT00810888|144659332|SUPERIORITY|||||||0.66|||||||Fisher Exact|||Only the randomized subjects will be compared||||0.66
72563938|NCT00810888|144659333|SUPERIORITY||Sensitivity|38.5||||0.004|TWO_SIDED|95.0|17.6|64.6|||Fisher Exact|||||64.6|17.6|0.004
72464136|NCT01907113|144451224|NON_INFERIORITY_OR_EQUIVALENCE|Ratio calculated as kidney failure divided by normal renal function|Geometric mean ratio|103.75|STANDARD_DEVIATION|29.7|||TWO_SIDED|95.0|81.18|132.61|||ANOVA|Based on ANOVA with fixed effect for treatment (corresponding to renal impairment status).|Standard deviation is actually the geometric Coefficient of Variation \[%\].|No formal testing, investigation of relative bioavailability||132.61|81.18|
72464137|NCT00833898|144451239|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED||||||Mixed Models Analysis|||||||0.020
72464138|NCT00833898|144451240|SUPERIORITY_OR_OTHER|||||||0.15|TWO_SIDED||||||Mixed Models Analysis|||||||0.15
72464139|NCT00833898|144451241|SUPERIORITY_OR_OTHER|||||||0.029|TWO_SIDED||||||Mixed Models Analysis|||||||0.029
72464140|NCT00833898|144451242|SUPERIORITY_OR_OTHER|||||||0.003|TWO_SIDED||||||Mixed Models Analysis|||||||0.003
72464141|NCT00833898|144451243|SUPERIORITY_OR_OTHER|||||||0.012|TWO_SIDED||||||Mixed Models Analysis|||||||0.012
72464142|NCT00833898|144451244|SUPERIORITY_OR_OTHER|||||||0.4|TWO_SIDED||||||Mixed Models Analysis|||||||0.40
72464143|NCT00833898|144451245|SUPERIORITY_OR_OTHER|||||||0.44|TWO_SIDED||||||Mixed Models Analysis|||||||0.44
72464144|NCT00833898|144451246|SUPERIORITY_OR_OTHER|||||||0.75|TWO_SIDED||||||Mixed Models Analysis|||||||0.75
72464145|NCT00833898|144451247|SUPERIORITY_OR_OTHER|||||||0.17|TWO_SIDED||||||Mixed Models Analysis|||||||0.17
72563939|NCT00810888|144659334|SUPERIORITY||Specificity|94.2||||0.004|TWO_SIDED|95.0|85.6|98.1|||Fisher Exact|||||98.1|85.6|0.004
72563940|NCT00810888|144659335|SUPERIORITY|||||||0.47|||||||Fisher Exact|||||||0.47
72563941|NCT00810888|144659336|SUPERIORITY|||||||0.58|||||||Fisher Exact|||||||0.58
72563942|NCT00810888|144659337|OTHER|A Kappa test of overall agreement was used|Kappa|0.77|||||TWO_SIDED|95.0|0.61|0.93|||||A kappa of \>0.75 is considered excellent agreement|||0.93|0.61|
72563943|NCT00810888|144659338|SUPERIORITY|||||||0.25|||||||Kruskal-Wallis|||Groups 1 and 2 only the spot positive subjects randomized to interventional drug or placebo||||0.25
72621247|NCT02732145|144773188|SUPERIORITY|Question: Is there a difference in the frequency of previous systemic treatment with antibiotics between the patients with vulvar dermatosis and vulvodynia?||||||0.2131|||||||Chi-squared|||Parameter: The difference in the frequency of previous systemic treatment with antibiotics among patients with vulvar dermatosis and vulvodynia.||||0.2131
72621248|NCT02732145|144773188|SUPERIORITY|Question: Is there a difference in the frequency of previous local treatment with corticosteroids between the patients with vulvar dermatosis and vulvodynia?||||||0|||||||Chi-squared|||Parameter: The difference in the frequency of previous local treatment with corticoids among patients with vulvar dermatosis and vulvodynia.||||0.0000
72621249|NCT02732145|144773188|SUPERIORITY|Question: Is there a difference in the frequency of previous systemic treatment with antidepressant between the patients with vulvar dermatosis and vulvodynia?||||||0.0962|||||||Chi-squared|||Parameter: The difference in the frequency of previous systemic treatment with antidepressant among patients with vulvar dermatosis and vulvodynia.||||0.0962
72621250|NCT02732145|144773189|EQUIVALENCE|Question: Is there a difference in the incidence of a positive Cotton-Swab test of the vulva among patients from different groups?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of a positive Cotton-Swab test of the vulva among patients from different groups.||||0.0000
72621251|NCT02732145|144773189|EQUIVALENCE|Question: Is there a difference in the incidence of a positive Cotton-Swab test at the point marked as 2h among patients from different groups?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of a positive Cotton-Swab test at the point marked as 2h among patients from different groups.||||0.0000
72621252|NCT02732145|144773189|EQUIVALENCE|Question: Is there a difference in the incidence of a positive Cotton-Swab test at the point marked as 4h among patients from different groups?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of a positive Cotton-Swab test at the point marked as 4h among patients from different groups.||||0.0000
72464146|NCT00833898|144451248|SUPERIORITY_OR_OTHER|||||||0.97|TWO_SIDED||||||Mixed Models Analysis|||||||0.97
72464147|NCT00833898|144451249|SUPERIORITY_OR_OTHER|||||||0.55|TWO_SIDED||||||Mixed Models Analysis|||||||0.55
72464148|NCT00833898|144451250|SUPERIORITY_OR_OTHER|||||||0.3|TWO_SIDED||||||Mixed Models Analysis|||||||0.30
72464149|NCT00833898|144451251|SUPERIORITY_OR_OTHER|||||||0.67|TWO_SIDED||||||Mixed Models Analysis|||||||0.67
72464150|NCT00833898|144451252|SUPERIORITY_OR_OTHER|||||||0.013|TWO_SIDED||||||Mixed Models Analysis|||||||0.013
72464151|NCT00833898|144451253|SUPERIORITY_OR_OTHER|||||||0.8|TWO_SIDED||||||Mixed Models Analysis|||||||0.80
72464152|NCT00833898|144451254|SUPERIORITY_OR_OTHER|||||||0.26|TWO_SIDED||||||Mixed Models Analysis|||||||0.26
72464153|NCT00833898|144451255|SUPERIORITY_OR_OTHER|||||||0.58|TWO_SIDED|||||P-values represent separate wilcoxon paired sample signed rank test.|Wilcoxon (Mann-Whitney)|||||||.58
72464154|NCT00833898|144451255|SUPERIORITY_OR_OTHER|||||||0.33|TWO_SIDED|||||P-values represent separate wilcoxon paired sample signed rank test.|Wilcoxon (Mann-Whitney)|||||||.33
72464155|NCT00833898|144451256|SUPERIORITY_OR_OTHER|||||||0.53|TWO_SIDED||||||Mixed Models Analysis|||||||0.53
72464156|NCT00833898|144451257|SUPERIORITY_OR_OTHER|||||||0.18|TWO_SIDED|||||P-values represent separate wilcoxon paired sample signed rank test.|Wilcoxon (Mann-Whitney)|||||||.18
72464157|NCT00833898|144451257|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED|||||P-values represent separate wilcoxon paired sample signed rank test.|Wilcoxon (Mann-Whitney)|||||||1.00
72464158|NCT00833898|144451258|SUPERIORITY_OR_OTHER|||||||0.43|TWO_SIDED|||||P-values represent separate wilcoxon paired sample signed rank test.|Wilcoxon (Mann-Whitney)|||||||.43
72464159|NCT00833898|144451258|SUPERIORITY_OR_OTHER|||||||0.72|TWO_SIDED|||||P-values represent separate wilcoxon paired sample signed rank test.|Wilcoxon (Mann-Whitney)|||||||.72
72464160|NCT00833898|144451259|SUPERIORITY_OR_OTHER|||||||0.43|TWO_SIDED|||||P-values represent separate wilcoxon paired sample signed rank test.|Wilcoxon (Mann-Whitney)|||||||.43
72464161|NCT00833898|144451259|SUPERIORITY_OR_OTHER|||||||0.72|TWO_SIDED|||||P-values represent separate wilcoxon paired sample signed rank test.|Wilcoxon (Mann-Whitney)|||||||.72
72464162|NCT01057888|144451271|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.3|||<|0.05|TWO_SIDED|95.0|1.0|1.7|||Regression, Cox|It is a robust, clustered stratified Cox regression model|The control group serves as the denominator. The telephone reminder group serves as the numerator.|The null hypothesis is that there is no difference in total immunization status between the control group and the group receiving telephone (autodialer) reminders. This was analyzed using a clustered, stratified Cox model.||1.7|1.0|<0.05
72464163|NCT01057888|144451271|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.6|||<|0.01|TWO_SIDED|95.0|1.3|2.1|||Regression, Cox|We used a robust, clustered, stratified Cox regression model.|The control group represents the denominator. The letter reminder group represents the numerator.|||2.1|1.3|<0.01
72464164|NCT01057888|144451271|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.2||||0.075|TWO_SIDED|95.0|1.0|1.6|||Regression, Cox||The mail reminder arm represents the numerator and the telephone reminder arm represents the denominator.|The null hypothesis was that there is no difference in the percentage of fully vaccinated adolescents between the mailed reminder versus the telephone reminder arms||1.6|1.0|0.075
72464165|NCT01057888|144451272|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.2|||<|0.01|TWO_SIDED|95.0|1.1|1.3|||Regression, Cox||The control group represents the denominator and the mailed reminder group represents the numerator.|The null hypothesis was that a difference in well child care rates among adolescents whose families received a mailed reminder compared to the control group||1.3|1.1|<0.01
72464166|NCT01057888|144451272|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.1|||<|0.05|TWO_SIDED|95.0|1.0|1.3|||Regression, Cox||The control group represents the denominator and the telephone reminder group represents the numerator|The null hypothesis is the the well child care rates of adolescents in the telephone reminder group would not differ from those of the control group||1.3|1.0|<0.05
72464167|NCT01057888|144451272|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.1||||0.234|TWO_SIDED|95.0|1.0|1.2|||Regression, Cox||The mail reminder arm represents the numerator and the telephone reminder arm represents the denominator|The null hypothesis was that there would be no difference in the well child care rate among adolescents in the mailed reminder arm versus adolescents in the telephone reminder arm of the intervention||1.2|1.0|0.234
72621253|NCT02732145|144773189|EQUIVALENCE|Question: Is there a difference in the incidence of a positive Cotton-Swab test at the point marked as 6h among patients from different groups?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of a positive Cotton-Swab test at the point marked as 6h among patients from different groups.||||0.0000
72464168|NCT03972137|144451324|OTHER|A paired-samples t-test was conducted to compare changes in cigarettes smoked per day from Baseline (BL) to Quit Day.|Mean Difference (Final Values)|11.42|STANDARD_DEVIATION|6.08||0.003|TWO_SIDED|95.0|5.79|17.05||The threshold for statistical significance was p \< 0.05.|t-test, 2 sided||Mean difference represents the difference of mean cigarettes smoked per day at Baseline and Quit Date (Mean CPD at Baseline - Mean CPD at Quit Date).|||17.05|5.79|.003
72464169|NCT03972137|144451324|OTHER|A paired-samples t-test was used to evaluate smoking reduction in participants from baseline (BL) to 3-month follow-up session (3MFU).|Mean Difference (Final Values)|11.9|STANDARD_DEVIATION|8.45||0.067|TWO_SIDED|95.0|-1.55|25.35||The threshold for statistical significance was p \< 0.05.|t-test, 2 sided||Mean difference represents the difference of mean cigarettes smoked per day at Baseline and 3-month follow-up. Estimated value reported is reflective of the n=4 participants that attended the 3-month follow-up session.|||25.35|-1.55|.067
72502386|NCT03182738|144535391|SUPERIORITY|"Linear mixed models to test difference in mean muscle aches score from period 1 to period 2 between the two arms."|Difference in Change|0.09||||0.56|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in muscle aches score from period 1 to period 2 between the two arms."|"The null hypothesis is that there is no difference in change in mean muscle aches score from period 1 to period 2 between the two arms"||||0.56
72502387|NCT03182738|144535391|SUPERIORITY|"Linear mixed models to test difference in mean speech difficulties score from period 1 to period 2 between the two arms."|Difference in Change|0.1||||0.22|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in speech difficulties score from period 1 to period 2 between the two arms."|"The null hypothesis is that there is no difference in change in mean speech difficulties score from period 1 to period 2 between the two arms"||||0.22
72621254|NCT02732145|144773189|EQUIVALENCE|Question: Is there a difference in the incidence of a positive Cotton-Swab test at the point marked as 8h among patients from different groups?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of a positive Cotton-Swab test at the point marked as 8h among patients from different groups.||||0.0000
72502388|NCT03182738|144535391|SUPERIORITY|"Linear mixed models to test difference in mean decreased sex drive score from period 1 to period 2 between the two arms."|Difference in Change|0.11||||0.4|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in decreased sex drive score from period 1 to period 2 between the two arms."|"The null hypothesis is that there is no difference in change in mean decreased sex drive score from period 1 to period 2 between the two arms"||||0.40
72502389|NCT03182738|144535391|SUPERIORITY|"Linear mixed models to test difference in mean anxiety score from period 1 to period 2 between the two arms."|Difference in Change|0.13||||0.35|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in anxiety score from period 1 to period 2 between the two arms."|"The null hypothesis is that there is no difference in change in mean anxiety score from period 1 to period 2 between the two arms"||||0.35
72502390|NCT03182738|144535391|SUPERIORITY|"Linear mixed models to test difference in mean difficulty concentrating score from period 1 to period 2 between the two arms."|Difference in Change|0.17||||0.11|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in difficulty concentrating score from period 1 to period 2 between the two arms."|"The null hypothesis is that there is no difference in change in mean difficulty concentrating score from period 1 to period 2 between the two arms"||||0.11
72502391|NCT03182738|144535391|SUPERIORITY|"Linear mixed models to test difference in mean shortness of breath score from period 1 to period 2 between the two arms."|Difference in Change|0.2||||0.11|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in shortness of breath score from period 1 to period 2 between the two arms."|"The null hypothesis is that there is no difference in change in mean shortness of breath score from period 1 to period 2 between the two arms"||||0.11
72502392|NCT03182738|144535391|SUPERIORITY|"Linear mixed models to test difference in mean difficulty falling asleep score from period 1 to period 2 between the two arms."|Difference in Change|0.2||||0.15|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in difficulty falling asleep score from period 1 to period 2 between the two arms."|"The null hypothesis is that there is no difference in change in mean difficulty falling asleep score from period 1 to period 2 between the two arms"||||0.15
72504821|NCT03114969|144540519|SUPERIORITY||Odds Ratio (OR)|1.51||||0.472|TWO_SIDED|95.0|0.492|4.633||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.|||4.633|0.492|0.472
72621255|NCT02732145|144773189|EQUIVALENCE|Question: Is there a difference in the incidence of a positive Cotton-Swab test at the point marked as 10h among patients from different groups?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of a positive Cotton-Swab test at the point marked as 10h among patients from different groups.||||0.0000
72621256|NCT02732145|144773189|EQUIVALENCE|Question: Is there a difference in the incidence of a positive Cotton-Swab test at the point marked as 12h among patients from different groups?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of a positive Cotton-Swab test at the point marked as 12h among patients from different groups.||||0.0000
72621257|NCT02732145|144773189|SUPERIORITY|Question: Is there a difference in the incidence of a positive Cotton-Swab test of the vulva in patients with vulvar dermatosis versus normal vulva?||||||0.0009|||||||Chi-squared|||Parameter: The difference in the incidence of a positive Cotton-Swab test of the vulva in patients with vulvar dermatosis versus normal vulva.||||0.0009
72464170|NCT03972137|144451325|OTHER|A paired-samples t-test was conducted to examine the difference in the DASS-21 total score from baseline (BL) to 2-weeks post-quit (2W).|Mean Difference (Final Values)|19.67|STANDARD_DEVIATION|11.91||0.01|TWO_SIDED|95.0|7.17|32.17||The threshold for statistical significance was p \< 0.05.|t-test, 2 sided||Mean difference represents the difference of mean DASS-21 total scores at Baseline and 2-weeks post-quit. Estimated value reported is reflective of the n=6 participants that attended the 2-weeks post quit session.|||32.17|7.17|.010
72464171|NCT03972137|144451325|OTHER|A paired-samples t-test was conducted to examine the difference in DASS-21 Total scores from baseline (BL) to 1-month post-quit (1M).|Mean Difference (Final Values)|31.2|STANDARD_DEVIATION|20.4||0.027|TWO_SIDED|95.0|5.88|56.52||The threshold for statistical significance was p \< 0.05.|t-test, 2 sided||Mean difference represents the difference of mean DASS-21 total scores at Baseline and 1-month post-quit. Estimated value reported is reflective of the n=5 participants that attended the 1-month post-quit session.|||56.52|5.88|.027
72464172|NCT03972137|144451325|OTHER|A paired-samples t-test was conducted to evaluate the difference in DASS-21 total scores from baseline (BL) to 3-month follow up (3MFU).|Mean Difference (Final Values)|25.75|STANDARD_DEVIATION|15.5||0.045|TWO_SIDED|95.0|1.09|50.41||The threshold for statistical significance was p \< 0.05.|t-test, 2 sided||Mean difference represents the difference of mean DASS-21 total scores at Baseline and 3-month follow-up. Estimated value reported is reflective of the n=4 participants that attended the 3-month follow-up session.|||50.41|1.09|.045
72464173|NCT01797822|144451339|OTHER|Statistical comparison between groups was made with t-test. A sample size of 20 subjects was calculates to have 90% power of detecting a statistical difference (P\<0.05) in change in corneal staining pre and post low humidity challenge.|||||<|0.05|||||||t-test, 1 sided|||||||<0.05
72464174|NCT01960114|144451359|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|25.241|STANDARD_ERROR_OF_MEAN|2.8344|<|0.001|TWO_SIDED|95.0|19.669|30.813||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||30.813|19.669|<0.001
72464175|NCT01960114|144451360|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||The significance threshold level was 0.05 (two-sided). p-Values are based on the Wilcoxon test from PROC LIFETEST that compared survival curves.|Wilcoxon test, from SAS PROC LIFETEST|||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
72464176|NCT01960114|144451361|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||The significance threshold level was 0.05 (two-sided). p-Values are based on the Wilcoxon test from PROC LIFETEST that compared survival curves.|Wilcoxon test, from SAS PROC LIFETEST|||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
72464177|NCT01960114|144451362|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||The significance threshold level was 0.05 (two-sided). p-Values are based on the log-rank test from PROC LIFETEST that compared survival curves.|Log Rank|||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. Subjects who withdrew from the study before 12 hours, but did not use rescue therapy, were censored at the time of withdrawal. Subjects not rescuing during the 12-hour study period had their time to rescue set to 12 hours and were censored.||||<0.001
72464178|NCT01960114|144451363|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED|||||The significance threshold level was 0.05 (two-sided).|Cochran-Mantel-Haenszel|Used row-mean scores based on Cochran-Mantel-Haenszel test was stratified by baseline categorical pain score.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||0.001
72464179|NCT02469077|144451364|SUPERIORITY|||||||0.12|||||||ANCOVA|||Statistical analysis applies to change after 6 week intervention period||||0.12
72464180|NCT02469077|144451365|SUPERIORITY|||||||0.04|||||||ANCOVA|||Statistical analysis applies to change after 6 week intervention period||||.04
72464181|NCT02469077|144451366|SUPERIORITY|||||||0.03|||||||ANCOVA|||Statistical analysis applies to change after 6 week intervention period||||.03
72464182|NCT02469077|144451367|SUPERIORITY|||||||0.17|||||||ANCOVA|||Statistical analysis applies to change after 6 week intervention period||||0.17
72464183|NCT02469077|144451368|SUPERIORITY|||||||0.13|||||||ANCOVA|||Statistical analysis applies to change after 6 week intervention period||||0.13
72464184|NCT02469077|144451369|SUPERIORITY|||||||0.98|||||||ANCOVA|||Statistical analysis applies to change after 6 week intervention period||||.98
72464185|NCT02469077|144451370|SUPERIORITY|||||||0.52|||||||ANCOVA|||Statistical analysis applies to change after 6 week intervention period||||0.52
72464186|NCT02469077|144451371|SUPERIORITY|||||||0.65|||||||ANCOVA|||Statistical analysis applies to change after 6 week intervention period||||0.65
72464187|NCT02469077|144451372|SUPERIORITY|||||||0.1|||||||ANCOVA|||Statistical analysis applies to change after 6 week intervention period||||0.1
72464188|NCT02469077|144451373|SUPERIORITY|||||||0.046|||||||ANCOVA|||Statistical analysis applies to change after 6 week intervention period||||.046
72464189|NCT02469077|144451374|SUPERIORITY|||||||0.61|||||||ANCOVA|||Statistical analysis applies to change after 6 week intervention period||||0.61
72464190|NCT02469077|144451375|SUPERIORITY|||||||0.4|||||||ANCOVA|||Statistical analysis applies to change after 6 week intervention period||||0.4
72464191|NCT02469077|144451376|SUPERIORITY|||||||0.57|||||||ANCOVA|||Statistical analysis applies to change after 6 week intervention period||||0.57
72464192|NCT01040403|144451377|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.054|STANDARD_ERROR_OF_MEAN|0.019|||TWO_SIDED|95.0|0.016|0.092|||Mixed Models Analysis||Difference calculated as T+O 1.25/5 minus Olo 5|||0.092|0.016|
72464193|NCT01040403|144451377|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.065|STANDARD_ERROR_OF_MEAN|0.019|||TWO_SIDED|95.0|0.027|0.103|||Mixed Models Analysis||Difference calculated as T+O 2.5/5 minus Olo 5|||0.103|0.027|
72464194|NCT01040403|144451377|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.084|STANDARD_ERROR_OF_MEAN|0.02|||TWO_SIDED|95.0|0.046|0.122|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus Olo 5|||0.122|0.046|
72464195|NCT01040403|144451377|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.011|STANDARD_ERROR_OF_MEAN|0.019|||TWO_SIDED|95.0|-0.027|0.049|||Mixed Models Analysis||Difference calculated as T+O 2.5/5 minus T+O 1.25/5|||0.049|-0.027|
72464196|NCT01040403|144451377|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.03|STANDARD_ERROR_OF_MEAN|0.02|||TWO_SIDED|95.0|-0.008|0.069|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus T+O 1.25/5|||0.069|-0.008|
72464197|NCT01040403|144451377|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.019|STANDARD_ERROR_OF_MEAN|0.019|||TWO_SIDED|95.0|-0.019|0.058|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus T+O 2.5/5|||0.058|-0.019|
72464198|NCT01040403|144451377|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.051|STANDARD_ERROR_OF_MEAN|0.019|||TWO_SIDED|95.0|0.013|0.089|||Mixed Models Analysis||Difference calculated as T+O 1.25/10 minus Olo 10|||0.089|0.013|
72464199|NCT01040403|144451377|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.083|STANDARD_ERROR_OF_MEAN|0.019|||TWO_SIDED|95.0|0.045|0.122|||Mixed Models Analysis||Difference calculated as T+O 2.5/10 minus Olo 10|||0.122|0.045|
72464200|NCT01040403|144451377|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.08|STANDARD_ERROR_OF_MEAN|0.02|||TWO_SIDED|95.0|0.042|0.119|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus Olo 10|||0.119|0.042|
72464201|NCT01040403|144451377|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.033|STANDARD_ERROR_OF_MEAN|0.02|||TWO_SIDED|95.0|-0.006|0.071|||Mixed Models Analysis||Difference calculated as T+O 2.5/10 minus T+O 1.25/10|||0.071|-0.006|
72502393|NCT03182738|144535391|SUPERIORITY|"Linear mixed models to test difference in mean unplanned changes in weight score from period 1 to period 2 between the two arms."|Difference in Change|0.22||||0.08|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in unplanned changes in weight score from period 1 to period 2 between the two arms."|"The null hypothesis is that there is no difference in change in mean unplanned changes in weight score from period 1 to period 2 between the two arms"||||0.08
72621258|NCT02732145|144773189|SUPERIORITY|Question: Is there a difference in the incidence of a positive Cotton-Swab test at the point marked as 2h in patients with vulvar dermatosis versus normal vulva?||||||0.0289|||||||Chi-squared|||Parameter: The difference in the incidence of a positive Cotton-Swab test at the point marked as 2h in patients with vulvar dermatosis versus normal vulva.||||0.0289
72464202|NCT01040403|144451377|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.03|STANDARD_ERROR_OF_MEAN|0.019|||TWO_SIDED|95.0|-0.009|0.068|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus T+O 1.25/10|||0.068|-0.009|
72464203|NCT01040403|144451377|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.003|STANDARD_ERROR_OF_MEAN|0.019|||TWO_SIDED|95.0|-0.041|0.035|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus T+O 2.5/10|||0.035|-0.041|
72464204|NCT01040403|144451378|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.099|STANDARD_ERROR_OF_MEAN|0.03|||TWO_SIDED|95.0|0.04|0.159|||Mixed Models Analysis||Difference calculated as T+O 1.25/5 minus Olo 5|||0.159|0.040|
72464205|NCT01040403|144451378|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.12|STANDARD_ERROR_OF_MEAN|0.03|||TWO_SIDED|95.0|0.061|0.179|||Mixed Models Analysis||Difference calculated as T+O 2.5/5 minus Olo 5|||0.179|0.061|
72464206|NCT01040403|144451378|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.03|||TWO_SIDED|95.0|0.041|0.16|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus Olo 5|||0.160|0.041|
72464207|NCT01040403|144451378|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.03|||TWO_SIDED|95.0|-0.039|0.079|||Mixed Models Analysis||Difference calculated as T+O 2.5/5 minus T+O 1.25/5|||0.079|-0.039|
72464208|NCT01040403|144451378|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.001|STANDARD_ERROR_OF_MEAN|0.031|||TWO_SIDED|95.0|-0.059|0.061|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus T+O 1.25/5|||0.061|-0.059|
72464209|NCT01040403|144451378|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.019|STANDARD_ERROR_OF_MEAN|0.03|||TWO_SIDED|95.0|-0.079|0.04|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus T+O 2.5/5|||0.040|-0.079|
72464210|NCT01040403|144451378|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.131|STANDARD_ERROR_OF_MEAN|0.03|||TWO_SIDED|95.0|0.071|0.19|||Mixed Models Analysis||Difference calculated as T+O 1.25/10 minus Olo 10|||0.190|0.071|
72464211|NCT01040403|144451378|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.131|STANDARD_ERROR_OF_MEAN|0.03|||TWO_SIDED|95.0|0.072|0.191|||Mixed Models Analysis||Difference calculated as T+O 2.5/10 minus Olo 10|||0.191|0.072|
72464212|NCT01040403|144451378|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.127|STANDARD_ERROR_OF_MEAN|0.03|||TWO_SIDED|95.0|0.067|0.187|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus Olo 10|||0.187|0.067|
72464213|NCT01040403|144451378|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.001|STANDARD_ERROR_OF_MEAN|0.031|||TWO_SIDED|95.0|-0.059|0.061|||Mixed Models Analysis||Difference calculated as T+O 2.5/10 minus T+O 1.25/10|||0.061|-0.059|
72464214|NCT01040403|144451378|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.004|STANDARD_ERROR_OF_MEAN|0.03|||TWO_SIDED|95.0|-0.063|0.056|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus T+O 1.25/10|||0.056|-0.063|
72464215|NCT01040403|144451378|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.004|STANDARD_ERROR_OF_MEAN|0.03|||TWO_SIDED|95.0|-0.064|0.055|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus T+O 2.5/10|||0.055|-0.064|
72464216|NCT01040403|144451379|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.075|STANDARD_ERROR_OF_MEAN|0.02|||TWO_SIDED|95.0|0.035|0.114|||Mixed Models Analysis||Difference calculated as T+O 1.25/5 minus Olo 5|AUC 0-3h||0.114|0.035|
72464217|NCT01040403|144451379|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.097|STANDARD_ERROR_OF_MEAN|0.02|||TWO_SIDED|95.0|0.057|0.137|||Mixed Models Analysis||Difference calculated as T+O 2.5/5 minus Olo 5|AUC 0-3h||0.137|0.057|
72464218|NCT01040403|144451379|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.119|STANDARD_ERROR_OF_MEAN|0.02|||TWO_SIDED|95.0|0.079|0.159|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus Olo 5|AUC 0-3h||0.159|0.079|
72464219|NCT01040403|144451379|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.022|STANDARD_ERROR_OF_MEAN|0.02|||TWO_SIDED|95.0|-0.017|0.062|||Mixed Models Analysis||Difference calculated as T+O 2.5/5 minus T+O 1.25/5|AUC 0-3h||0.062|-0.017|
72464220|NCT01040403|144451379|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.045|STANDARD_ERROR_OF_MEAN|0.021|||TWO_SIDED|95.0|0.004|0.085|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus T+O 1.25/5|AUC 0-3h||0.085|0.004|
72464221|NCT01040403|144451379|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.022|STANDARD_ERROR_OF_MEAN|0.02|||TWO_SIDED|95.0|-0.018|0.062|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus T+O 2.5/5|AUC 0-3h||0.062|-0.018|
72464222|NCT01040403|144451379|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.097|STANDARD_ERROR_OF_MEAN|0.02|||TWO_SIDED|95.0|0.057|0.137|||Mixed Models Analysis||Difference calculated as T+O 1.25/10 minus Olo 10|AUC 0-3h||0.137|0.057|
72464223|NCT01040403|144451379|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.128|STANDARD_ERROR_OF_MEAN|0.02|||TWO_SIDED|95.0|0.088|0.168|||Mixed Models Analysis||Difference calculated as T+O 2.5/10 minus Olo 10|AUC 0-3h||0.168|0.088|
72464224|NCT01040403|144451379|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.143|STANDARD_ERROR_OF_MEAN|0.02|||TWO_SIDED|95.0|0.103|0.183|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus Olo 10|AUC 0-3h||0.183|0.103|
72464225|NCT01040403|144451379|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.031|STANDARD_ERROR_OF_MEAN|0.02|||TWO_SIDED|95.0|-0.009|0.071|||Mixed Models Analysis||Difference calculated as T+O 2.5/10 minus T+O 1.25/10|AUC 0-3h||0.071|-0.009|
72464226|NCT01040403|144451379|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.046|STANDARD_ERROR_OF_MEAN|0.02|||TWO_SIDED|95.0|0.006|0.086|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus T+O 1.25/10|AUC 0-3h||0.086|0.006|
72464227|NCT01040403|144451379|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.015|STANDARD_ERROR_OF_MEAN|0.02|||TWO_SIDED|95.0|-0.025|0.055|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus T+O 2.5/10|AUC 0-3h||0.055|-0.025|
72502394|NCT03182738|144535391|SUPERIORITY|"Linear mixed models to test difference in mean depression score from period 1 to period 2 between the two arms."|Difference in Change|0.34||||0.02|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in depression score from period 1 to period 2 between the two arms."|"The null hypothesis is that there is no difference in change in mean depression score from period 1 to period 2 between the two arms"||||0.02
72621259|NCT02732145|144773189|SUPERIORITY|Question: Is there a difference in the incidence of a positive Cotton-Swab test at the point marked as 4h in patients with vulvar dermatosis versus normal vulva?||||||0.0134|||||||Chi-squared|||Parameter: The difference in the incidence of a positive Cotton-Swab test at the point marked as 4h in patients with vulvar dermatosis and normal vulva.||||0.0134
72464228|NCT01040403|144451379|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.078|STANDARD_ERROR_OF_MEAN|0.02|||TWO_SIDED|95.0|0.04|0.117|||Mixed Models Analysis||Difference calculated as T+O 1.25/5 minus Olo 5|AUC 0-6h||0.117|0.040|
72464229|NCT01040403|144451379|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.099|STANDARD_ERROR_OF_MEAN|0.019|||TWO_SIDED|95.0|0.06|0.137|||Mixed Models Analysis||difference calculated as T+O 2.5/5 minus Olo 5|AUC 0-6h||0.137|0.060|
72464230|NCT01040403|144451379|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.118|STANDARD_ERROR_OF_MEAN|0.02|||TWO_SIDED|95.0|0.08|0.157|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus Olo 5|AUC 0-6h||0.157|0.080|
72464231|NCT01040403|144451379|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.019|||TWO_SIDED|95.0|-0.018|0.058|||Mixed Models Analysis||Difference calculated as T+O 2.5/5 minus T+O 1.25/5|AUC 0-6h||0.058|-0.018|
72464232|NCT01040403|144451379|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.04|STANDARD_ERROR_OF_MEAN|0.02|||TWO_SIDED|95.0|0.001|0.079|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus T+O 1.25/5|AUC 0-6h||0.079|0.001|
72464233|NCT01040403|144451379|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.02|||TWO_SIDED|95.0|-0.019|0.058|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus T+O 2.5/5|AUC 0-6h||0.058|-0.019|
72464234|NCT01040403|144451379|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.098|STANDARD_ERROR_OF_MEAN|0.02|||TWO_SIDED|95.0|0.06|0.136|||Mixed Models Analysis||Difference calculated as T+O 1.25/10 minus Olo 10|AUC 0-6h||0.136|0.060|
72464235|NCT01040403|144451379|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.121|STANDARD_ERROR_OF_MEAN|0.02|||TWO_SIDED|95.0|0.083|0.159|||Mixed Models Analysis||Difference calculated as T+O 2.5/10 minus Olo 10|AUC 0-6h||0.159|0.083|
72464236|NCT01040403|144451379|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.144|STANDARD_ERROR_OF_MEAN|0.02|||TWO_SIDED|95.0|0.105|0.182|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus Olo 10|AUC 0-6h||0.182|0.105|
72464237|NCT01040403|144451379|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.023|STANDARD_ERROR_OF_MEAN|0.02|||TWO_SIDED|95.0|-0.016|0.062|||Mixed Models Analysis||Difference calculated as T+O 2.5/10 minus T+O 1.25/10|AUC 0-6h||0.062|-0.016|
72464238|NCT01040403|144451379|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.046|STANDARD_ERROR_OF_MEAN|0.019|||TWO_SIDED|95.0|0.007|0.084|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus T+O 1.25/10|AUC 0-6h||0.084|0.007|
72464239|NCT01040403|144451379|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.023|STANDARD_ERROR_OF_MEAN|0.02|||TWO_SIDED|95.0|-0.016|0.061|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus T+O 2.5/10|AUC 0-6h||0.061|-0.016|
72464240|NCT01040403|144451380|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.023|STANDARD_ERROR_OF_MEAN|0.018|||TWO_SIDED|95.0|-0.058|0.012|||Mixed Models Analysis||Difference calculated as T+O 1.25/5 minus Olo 5|||0.012|-0.058|
72464241|NCT01040403|144451380|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.005|STANDARD_ERROR_OF_MEAN|0.018|||TWO_SIDED|95.0|-0.029|0.04|||Mixed Models Analysis||Difference calculated as T+O 2.5/5 minus Olo 5|||0.040|-0.029|
72464242|NCT01040403|144451380|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.001|STANDARD_ERROR_OF_MEAN|0.018|||TWO_SIDED|95.0|-0.034|0.036|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus Olo 5|||0.036|-0.034|
72621260|NCT02732145|144773189|SUPERIORITY|Question: Is there a difference in the incidence of a positive Cotton-Swab test at the point marked as 6h in patients with vulvar dermatosis versus normal vulva?||||||0.0037|||||||Chi-squared|||Parameter: The difference in the incidence of a positive Cotton-Swab test at the point marked as 6h in patients with vulvar dermatosis and normal vulva.||||0.0037
72393941|NCT01059825|144294280|SUPERIORITY_OR_OTHER||Difference in least squares means|-1.15||||0.007|TWO_SIDED|80.0|-1.75|-0.55||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-0.55|-1.75|0.007
72464243|NCT01040403|144451380|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.028|STANDARD_ERROR_OF_MEAN|0.018|||TWO_SIDED|95.0|-0.006|0.063|||Mixed Models Analysis||Difference calculated as T+O 2.5/5 minus T+O 1.25/5|||0.063|-0.006|
72563944|NCT02260258|144659439|EQUIVALENCE|Time variable log transformed and compared using linear regression controlling for shock stratification and site. Effect estimate represents geometric mean difference. Values above 1.0 favor longer duration in the NMB arm.|Geometric mean difference|1.0||||0.82|TWO_SIDED|95.0|0.7|1.4||A priori threshold for significance 0.05|Regression, Linear|||||1.4|0.7|0.82
72464244|NCT01040403|144451380|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.024|STANDARD_ERROR_OF_MEAN|0.018|||TWO_SIDED|95.0|-0.011|0.059|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus T+O 1.25/5|||0.059|-0.011|
72464245|NCT01040403|144451380|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.004|STANDARD_ERROR_OF_MEAN|0.018|||TWO_SIDED|95.0|-0.039|0.031|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus T+O 2.5/5|||0.031|-0.039|
72464246|NCT01040403|144451380|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.039|STANDARD_ERROR_OF_MEAN|0.018|||TWO_SIDED|95.0|0.004|0.073|||Mixed Models Analysis||Difference calculated as T+O 1.25/10 minus Olo 10|||0.073|0.004|
72464247|NCT01040403|144451380|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.031|STANDARD_ERROR_OF_MEAN|0.018|||TWO_SIDED|95.0|-0.004|0.066|||Mixed Models Analysis||Difference calculated as T+O 2.5/10 minus Olo 10|||0.066|-0.004|
72464248|NCT01040403|144451380|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.041|STANDARD_ERROR_OF_MEAN|0.018|||TWO_SIDED|95.0|0.006|0.076|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus Olo 10|||0.076|0.006|
72393942|NCT01059825|144294280|SUPERIORITY_OR_OTHER||Difference in least squares means|-1.75||||0|TWO_SIDED|80.0|-2.35|-1.14||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p \<0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-1.14|-2.35|0.000
72464249|NCT01040403|144451380|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.008|STANDARD_ERROR_OF_MEAN|0.018|||TWO_SIDED|95.0|-0.043|0.027|||Mixed Models Analysis||Difference calculated as T+O 2.5/10 minus T+O 1.25/10|||0.027|-0.043|
72464250|NCT01040403|144451380|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.003|STANDARD_ERROR_OF_MEAN|0.018|||TWO_SIDED|95.0|-0.032|0.037|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus T+O 1.25/10|||0.037|-0.032|
72464251|NCT01040403|144451380|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.018|||TWO_SIDED|95.0|-0.025|0.045|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus T+O 2.5/10|||0.045|-0.025|
72464252|NCT01040403|144451381|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.089|STANDARD_ERROR_OF_MEAN|0.025|||TWO_SIDED|95.0|0.041|0.138|||Mixed Models Analysis||Difference calculated as T+O 1.25/5 minus Olo 5|||0.138|0.041|
72464253|NCT01040403|144451381|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.091|STANDARD_ERROR_OF_MEAN|0.024|||TWO_SIDED|95.0|0.043|0.139|||Mixed Models Analysis||Difference calculated as T+O 2.5/5 minus Olo 5|||0.139|0.043|
72464254|NCT01040403|144451381|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.115|STANDARD_ERROR_OF_MEAN|0.025|||TWO_SIDED|95.0|0.066|0.164|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus Olo 5|||0.164|0.066|
72464255|NCT01040403|144451381|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.002|STANDARD_ERROR_OF_MEAN|0.025|||TWO_SIDED|95.0|-0.046|0.05|||Mixed Models Analysis||Difference calculated as T+O 2.5/5 minus T+O 1.25/5|||0.050|-0.046|
72464256|NCT01040403|144451381|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.026|STANDARD_ERROR_OF_MEAN|0.025|||TWO_SIDED|95.0|-0.023|0.074|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus T+O 1.25/5|||0.074|-0.023|
72464257|NCT01040403|144451381|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.024|STANDARD_ERROR_OF_MEAN|0.025|||TWO_SIDED|95.0|-0.025|0.072|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus T+O 2.5/5|||0.072|-0.025|
72464258|NCT01040403|144451381|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.107|STANDARD_ERROR_OF_MEAN|0.025|||TWO_SIDED|95.0|0.059|0.156|||Mixed Models Analysis||Difference calculated as T+O 1.25/10 minus Olo 10|||0.156|0.059|
72464259|NCT01040403|144451381|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.132|STANDARD_ERROR_OF_MEAN|0.025|||TWO_SIDED|95.0|0.084|0.181|||Mixed Models Analysis||Difference calculated as T+O 2.5/10 minus Olo 10|||0.181|0.084|
72464260|NCT01040403|144451381|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.145|STANDARD_ERROR_OF_MEAN|0.025|||TWO_SIDED|95.0|0.096|0.193|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus Olo 10|||0.193|0.096|
72464261|NCT01040403|144451381|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.025|STANDARD_ERROR_OF_MEAN|0.025|||TWO_SIDED|95.0|-0.024|0.074|||Mixed Models Analysis||Difference calculated as T+O 2.5/10 minus T+O 1.25/10|||0.074|-0.024|
72464262|NCT01040403|144451381|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.038|STANDARD_ERROR_OF_MEAN|0.025|||TWO_SIDED|95.0|-0.01|0.086|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus T+O 1.25/10|||0.086|-0.010|
72464263|NCT01040403|144451381|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.013|STANDARD_ERROR_OF_MEAN|0.025|||TWO_SIDED|95.0|-0.036|0.061|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus T+O 2.5/10|||0.061|-0.036|
72464264|NCT01040403|144451382|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.019|STANDARD_ERROR_OF_MEAN|0.02|||TWO_SIDED|95.0|-0.059|0.02|||Mixed Models Analysis||Difference calculated as T+O 1.25/5 minus Olo 5|||0.020|-0.059|
72563945|NCT02260258|144659440|EQUIVALENCE|LOS truncated at 28 days and compared using negative binomial regression controlling for stratification and site. Effect estimates represent incidence rate ratios. The parameter estimate, p value and CI provided below are from the negative binomial regression carried out all patients (N = 37 in NMB and 43 in Usual Care)|Incidence rate ratio|1.4||||0.09|TWO_SIDED|95.0|1.0|1.9|||Negative binomial regression|||All patients analyzed (N = 37 in NMB and 43 in Usual Care)||1.9|1.0|0.09
72563946|NCT02260258|144659440|EQUIVALENCE|LOS truncated at 28 days and compared using negative binomial regression controlling for stratification and site. Effect estimates represent incidence rate ratios. The parameter estimate, p value and CI provided below are from the negative binomial regression carried out on ICU survivors alone (n = 14 in NMB and 14 in Control)|Incidence rate ratio|1.3||||0.35|TWO_SIDED|95.0|0.8|2.0|||Negative binomial regression|||ICU survivors alone analyzed (n = 14 in each arm)||2.0|0.8|0.35
72464265|NCT01040403|144451382|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.014|STANDARD_ERROR_OF_MEAN|0.02|||TWO_SIDED|95.0|-0.026|0.053|||Mixed Models Analysis||Difference calculated as T+O 2.5/5 minus Olo 5|||0.053|-0.026|
72464266|NCT01040403|144451382|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.012|STANDARD_ERROR_OF_MEAN|0.02|||TWO_SIDED|95.0|-0.028|0.051|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus Olo 5|||0.051|-0.028|
72464267|NCT01040403|144451382|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.033|STANDARD_ERROR_OF_MEAN|0.02|||TWO_SIDED|95.0|-0.006|0.072|||Mixed Models Analysis||Difference calculated as T+O 2.5/5 minus T+O 1.25/5|||0.072|-0.006|
72464268|NCT01040403|144451382|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.031|STANDARD_ERROR_OF_MEAN|0.02|||TWO_SIDED|95.0|-0.009|0.071|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus T+O 1.25/5|||0.071|-0.009|
72464269|NCT01040403|144451382|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.002|STANDARD_ERROR_OF_MEAN|0.02|||TWO_SIDED|95.0|-0.041|0.037|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus T+O 2.5/5|||0.037|-0.041|
72464270|NCT01040403|144451382|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.054|STANDARD_ERROR_OF_MEAN|0.02|||TWO_SIDED|95.0|0.015|0.093|||Mixed Models Analysis||Difference calculated as T+O 1.25/10 minus Olo 10|||0.093|0.015|
72464271|NCT01040403|144451382|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.045|STANDARD_ERROR_OF_MEAN|0.02|||TWO_SIDED|95.0|0.006|0.084|||Mixed Models Analysis||Difference calculated as T+O 2.5/10 minus Olo 10|||0.084|0.006|
72464272|NCT01040403|144451382|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.047|STANDARD_ERROR_OF_MEAN|0.02|||TWO_SIDED|95.0|0.008|0.087|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus Olo 10|||0.087|0.008|
72464273|NCT01040403|144451382|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.009|STANDARD_ERROR_OF_MEAN|0.02|||TWO_SIDED|95.0|-0.049|0.031|||Mixed Models Analysis||Difference calculated as T+O 2.5/10 minus T+O 1.25/10|||0.031|-0.049|
72464274|NCT01040403|144451382|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.007|STANDARD_ERROR_OF_MEAN|0.02|||TWO_SIDED|95.0|-0.046|0.033|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus T+O 1.25/10|||0.033|-0.046|
72502395|NCT03182738|144535391|SUPERIORITY|"Linear mixed models to test difference in mean difficulty staying asleep score from period 1 to period 2 between the two arms."|Difference in Change|0.36||||0.01|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in difficulty staying asleep score from period 1 to period 2 between the two arms."|"The null hypothesis is that there is no difference in change in mean difficulty staying asleep score from period 1 to period 2 between the two arms"||||0.01
72621261|NCT02732145|144773189|SUPERIORITY|Question: Is there a difference in the incidence of a positive Cotton-Swab test at the point marked as 8h in patients with vulvar dermatosis and normal vulva?||||||0.008|||||||Chi-squared|||Parameter: The difference in the incidence of a positive Cotton-Swab test at the point marked as 8h in patients with vulvar dermatosis and normal vulva.||||0.0080
72464275|NCT01040403|144451382|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.002|STANDARD_ERROR_OF_MEAN|0.02|||TWO_SIDED|95.0|-0.037|0.042|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus T+O 2.5/10|||0.042|-0.037|
72464276|NCT01040403|144451383|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.143|STANDARD_ERROR_OF_MEAN|0.03|||TWO_SIDED|95.0|0.084|0.202|||Mixed Models Analysis||Difference calculated as T+O 1.25/5 minus Olo 5|AUC 0-3h||0.202|0.084|
72464277|NCT01040403|144451383|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.151|STANDARD_ERROR_OF_MEAN|0.03|||TWO_SIDED|95.0|0.092|0.21|||Mixed Models Analysis||Difference calculated as T+O 2.5/5 minus Olo 5|AUC 0-3h||0.210|0.092|
72464278|NCT01040403|144451383|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.131|STANDARD_ERROR_OF_MEAN|0.03|||TWO_SIDED|95.0|0.072|0.191|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus Olo 5|AUC 0-3h||0.191|0.072|
72464279|NCT01040403|144451383|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.008|STANDARD_ERROR_OF_MEAN|0.03|||TWO_SIDED|95.0|-0.051|0.066|||Mixed Models Analysis||Difference calculated as T+O 2.5/5 minus T+O 1.25/5|AUC 0-3h||0.066|-0.051|
72464280|NCT01040403|144451383|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.012|STANDARD_ERROR_OF_MEAN|0.03|||TWO_SIDED|95.0|-0.071|0.048|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus T+O 1.25/5|AUC 0-3h||0.048|-0.071|
72464281|NCT01040403|144451383|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.03|||TWO_SIDED|95.0|-0.079|0.039|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus T+O 2.5/5|AUC 0-3h||0.039|-0.079|
72464282|NCT01040403|144451383|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.175|STANDARD_ERROR_OF_MEAN|0.03|||TWO_SIDED|95.0|0.116|0.234|||Mixed Models Analysis||Difference calculated as T+O 1.25/10 minus Olo 10|AUC 0-3h||0.234|0.116|
72464283|NCT01040403|144451383|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.175|STANDARD_ERROR_OF_MEAN|0.03|||TWO_SIDED|95.0|0.116|0.234|||Mixed Models Analysis||Difference calculated as T+O 2.5/10 minus Olo 10|AUC 0-3h||0.234|0.116|
72464284|NCT01040403|144451383|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|0.03|||TWO_SIDED|95.0|0.14|0.259|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus Olo 10|AUC 0-3h||0.259|0.140|
72464285|NCT01040403|144451383|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.03|||TWO_SIDED|95.0|-0.06|0.059|||Mixed Models Analysis||Difference calculated as T+O 2.5/10 minus T+O 1.25/10|AUC 0-3h||0.059|-0.060|
72464286|NCT01040403|144451383|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.024|STANDARD_ERROR_OF_MEAN|0.03|||TWO_SIDED|95.0|-0.035|0.083|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus T+O 1.25/10|AUC 0-3h||0.083|-0.035|
72464287|NCT01040403|144451383|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.024|STANDARD_ERROR_OF_MEAN|0.03|||TWO_SIDED|95.0|-0.035|0.083|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus T+O 2.5/10|AUC 0-3h||0.083|-0.035|
72464288|NCT01040403|144451383|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.139|STANDARD_ERROR_OF_MEAN|0.029|||TWO_SIDED|95.0|0.081|0.197|||Mixed Models Analysis||Difference calculated as T+O 1.25/5 minus Olo 5|AUC 0-6h||0.197|0.081|
72464289|NCT01040403|144451383|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.15|STANDARD_ERROR_OF_MEAN|0.029|||TWO_SIDED|95.0|0.092|0.207|||Mixed Models Analysis||Difference calculated as T+O 2.5/5 minus Olo 5|AUC 0-6h||0.207|0.092|
72621262|NCT02732145|144773189|SUPERIORITY|Question: Is there a difference in the incidence of a positive Cotton-Swab test at the point marked as 10h in patients with vulvar dermatosis versus normal vulva?||||||0.0579|||||||Chi-squared|||Parameter: The difference in the incidence of a positive Cotton-Swab test at the point marked as 10h in patients with vulvar dermatosis and normal vulva.||||0.0579
72621263|NCT02732145|144773189|SUPERIORITY|Question: Is there a difference in the incidence of a positive Cotton-Swab test at the point marked as 12h in patients with vulvar dermatosis versus normal vulva?||||||0.072|||||||Chi-squared|||Parameter: The difference in the incidence of a positive Cotton-Swab test at the point marked as 12h in patients with vulvar dermatosis and normal vulva.||||0.0720
72563947|NCT02260258|144659441|EQUIVALENCE|Duration log transformed and compared using linear regression controlling for shock stratification and site. Includes all patients (n=37 in NMB and n = 43 in control). Effect estimates represent geometric mean difference. Values above 1.0 favor longer duration in the NMB arm.|Geometric mean difference|1.3||||0.18|TWO_SIDED|95.0|0.9|1.9|||Regression, Linear|Duration log transformed and so parameter estimate represents geometric mean difference.||Anaysis for the full data (n= 37 in NMB and 43 in Control)||1.9|0.9|0.18
72563948|NCT02260258|144659441|EQUIVALENCE|Duration log transformed and compared using linear regression controlling for shock stratification and site. Includes patients surviving to discontinuation of mechanical ventilation (n=14 in each group). Two patients discharged from the hospital on mechanical ventilation have duration truncated at time of discharge and are considered survivors to extubation. Effect estimates represent geometric mean difference. Values above 1.0 favor longer duration in the NMB arm.|Geometric mean difference|1.4||||0.32|TWO_SIDED|95.0|0.7|2.9|||Regression, Linear|Duration log transformed and so parameter estimate represents geometric mean difference.||Anaysis for the patients surviving to extubation (n= 14 in both groups)||2.9|0.7|0.32
72621264|NCT02732145|144773190|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of the Outer Vulvar Ring between patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of non-specific lesions of the Outer Vulvar Ring in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of vulvodynia."||||0.0000
72621265|NCT02732145|144773190|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of the Middle Vulvar Ring between patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of non-specific lesions of the Middle Vulvar Ring in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of vulvodynia."||||0.0000
72464290|NCT01040403|144451383|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.131|STANDARD_ERROR_OF_MEAN|0.029|||TWO_SIDED|95.0|0.073|0.189|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus Olo 5|AUC 0-6h||0.189|0.073|
72464291|NCT01040403|144451383|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.011|STANDARD_ERROR_OF_MEAN|0.029|||TWO_SIDED|95.0|-0.047|0.068|||Mixed Models Analysis||Difference calculated as T+O 2.5/5 minus T+O 1.25/5|AUC 0-6h||0.068|-0.047|
72464292|NCT01040403|144451383|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.008|STANDARD_ERROR_OF_MEAN|0.03|||TWO_SIDED|95.0|-0.066|0.051|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus T+O 1.25/5|AUC 0-6h||0.051|-0.066|
72464293|NCT01040403|144451383|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.018|STANDARD_ERROR_OF_MEAN|0.029|||TWO_SIDED|95.0|-0.076|0.039|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus T+O 2.5/5|AUC 0-6h||0.039|-0.076|
72464294|NCT01040403|144451383|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.189|STANDARD_ERROR_OF_MEAN|0.029|||TWO_SIDED|95.0|0.131|0.247|||Mixed Models Analysis||Difference calculated as T+O 1.25/10 minus Olo 10|AUC 0-6h||0.247|0.131|
72464295|NCT01040403|144451383|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.179|STANDARD_ERROR_OF_MEAN|0.029|||TWO_SIDED|95.0|0.121|0.236|||Mixed Models Analysis||Difference calculated as T+O 2.5/10 minus Olo 10|AUC 0-6h||0.236|0.121|
72464296|NCT01040403|144451383|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.213|STANDARD_ERROR_OF_MEAN|0.029|||TWO_SIDED|95.0|0.155|0.271|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus Olo 10|AUC 0-6h||0.271|0.155|
72464297|NCT01040403|144451383|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.03|||TWO_SIDED|95.0|-0.069|0.048|||Mixed Models Analysis||Difference calculated as T+O 2.5/10 minus T+O 1.25/10|AUC 0-6h||0.048|-0.069|
72464298|NCT01040403|144451383|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.024|STANDARD_ERROR_OF_MEAN|0.029|||TWO_SIDED|95.0|-0.033|0.082|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus T+O 1.25/10|AUC 0-6h||0.082|-0.033|
72563949|NCT02260258|144659442|EQUIVALENCE|Comparison made using logistic regression controlling for shock stratification and site. Effect estimates represent odds ratios|Odds Ratio (OR)|1.3||||0.63|TWO_SIDED|95.0|0.5|3.3|||Regression, Logistic|||||3.3|0.5|0.63
72464299|NCT01040403|144451383|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.035|STANDARD_ERROR_OF_MEAN|0.029|||TWO_SIDED|95.0|-0.023|0.092|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus T+O 2.5/10|AUC 0-6h||0.092|-0.023|
72464300|NCT01040403|144451384|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.048|STANDARD_ERROR_OF_MEAN|0.029|||TWO_SIDED|95.0|-0.106|0.01|||Mixed Models Analysis||Difference calculated as T+O 1.25/5 minus Olo 5|||0.010|-0.106|
72464301|NCT01040403|144451384|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.007|STANDARD_ERROR_OF_MEAN|0.029|||TWO_SIDED|95.0|-0.065|0.051|||Mixed Models Analysis||Difference calculated as T+O 2.5/5 minus Olo 5|||0.051|-0.065|
72464302|NCT01040403|144451384|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.014|STANDARD_ERROR_OF_MEAN|0.03|||TWO_SIDED|95.0|-0.072|0.044|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus Olo 5|||0.044|-0.072|
72464303|NCT01040403|144451384|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.041|STANDARD_ERROR_OF_MEAN|0.029|||TWO_SIDED|95.0|-0.017|0.099|||Mixed Models Analysis||Difference calculated as T+O 2.5/5 minus T+O 1.25/5|||0.099|-0.017|
72464304|NCT01040403|144451384|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.034|STANDARD_ERROR_OF_MEAN|0.03|||TWO_SIDED|95.0|-0.024|0.093|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus T+O 1.25/5|||0.093|-0.024|
72563950|NCT02260258|144659443|EQUIVALENCE|Comparison made using logistic regression controlling for shock stratification and site. Effect estimates represent odds ratios|Odds Ratio (OR)|1.7||||0.35|TWO_SIDED|95.0|0.6|4.7|||Regression, Logistic|||||4.7|0.6|0.35
72563951|NCT02563769|144659451|SUPERIORITY|||||||0.69|||||||Wilcoxon (Mann-Whitney)|||||||0.69
72563952|NCT02563769|144659451|SUPERIORITY|||||||0.46|||||||Wilcoxon (Mann-Whitney)|||||||0.46
72464305|NCT01040403|144451384|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.007|STANDARD_ERROR_OF_MEAN|0.03|||TWO_SIDED|95.0|-0.065|0.051|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus T+O 2.5/5|||0.051|-0.065|
72464306|NCT01040403|144451384|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.09|STANDARD_ERROR_OF_MEAN|0.03|||TWO_SIDED|95.0|0.032|0.148|||Mixed Models Analysis||Difference calculated as T+O 1.25/10 minus Olo 10|||0.148|0.032|
72464307|NCT01040403|144451384|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.059|STANDARD_ERROR_OF_MEAN|0.03|||TWO_SIDED|95.0|0.001|0.118|||Mixed Models Analysis||Difference calculated as T+O 2.5/10 minus Olo 10|||0.118|0.001|
72464308|NCT01040403|144451384|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.056|STANDARD_ERROR_OF_MEAN|0.03|||TWO_SIDED|95.0|-0.002|0.114|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus Olo 10|||0.114|-0.002|
72464309|NCT01040403|144451384|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.031|STANDARD_ERROR_OF_MEAN|0.03|||TWO_SIDED|95.0|-0.089|0.028|||Mixed Models Analysis||Difference calculated as T+O 2.5/10 minus T+O 1.25/10|||0.028|-0.089|
72464310|NCT01040403|144451384|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.034|STANDARD_ERROR_OF_MEAN|0.03|||TWO_SIDED|95.0|-0.092|0.024|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus T+O 1.25/10|||0.024|-0.092|
72464311|NCT01040403|144451384|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.003|STANDARD_ERROR_OF_MEAN|0.03|||TWO_SIDED|95.0|-0.062|0.055|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus T+O 2.5/10|||0.055|-0.062|
72464312|NCT01040403|144451385|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.155|STANDARD_ERROR_OF_MEAN|0.035|||TWO_SIDED|95.0|0.087|0.223|||Mixed Models Analysis||Difference calculated as T+O 1.25/5 minus Olo 5|||0.223|0.087|
72464313|NCT01040403|144451385|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.147|STANDARD_ERROR_OF_MEAN|0.035|||TWO_SIDED|95.0|0.079|0.215|||Mixed Models Analysis||Difference calculated as T+O 2.5/5 minus Olo 5|||0.215|0.079|
72464314|NCT01040403|144451385|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.127|STANDARD_ERROR_OF_MEAN|0.035|||TWO_SIDED|95.0|0.058|0.195|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus Olo 5|||0.195|0.058|
72464315|NCT01040403|144451385|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.008|STANDARD_ERROR_OF_MEAN|0.035|||TWO_SIDED|95.0|-0.075|0.06|||Mixed Models Analysis||Difference calculated as T+O 2.5/5 minus T+O 1.25/5|||0.060|-0.075|
72464316|NCT01040403|144451385|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.028|STANDARD_ERROR_OF_MEAN|0.035|||TWO_SIDED|95.0|-0.097|0.041|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus T+O 1.25/5|||0.041|-0.097|
72464317|NCT01040403|144451385|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.035|||TWO_SIDED|95.0|-0.089|0.048|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus T+O 2.5/5|||0.048|-0.089|
72464318|NCT01040403|144451385|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.174|STANDARD_ERROR_OF_MEAN|0.035|||TWO_SIDED|95.0|0.106|0.242|||Mixed Models Analysis||Difference calculated as T+O 1.25/10 minus Olo 10|||0.242|0.106|
72464319|NCT01040403|144451385|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.182|STANDARD_ERROR_OF_MEAN|0.035|||TWO_SIDED|95.0|0.113|0.25|||Mixed Models Analysis||Difference calculated as T+O 2.5/10 minus Olo 10|||0.250|0.113|
72464320|NCT01040403|144451385|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.204|STANDARD_ERROR_OF_MEAN|0.035|||TWO_SIDED|95.0|0.135|0.272|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus Olo 10|||0.272|0.135|
72464321|NCT01040403|144451385|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.008|STANDARD_ERROR_OF_MEAN|0.035|||TWO_SIDED|95.0|-0.061|0.076|||Mixed Models Analysis||Difference calculated as T+O 2.5/10 minus T+O 1.25/10|||0.076|-0.061|
72464322|NCT01040403|144451385|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.03|STANDARD_ERROR_OF_MEAN|0.035|||TWO_SIDED|95.0|-0.038|0.098|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus T+O 1.25/10|||0.098|-0.038|
72464323|NCT01040403|144451385|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.022|STANDARD_ERROR_OF_MEAN|0.035|||TWO_SIDED|95.0|-0.046|0.09|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus T+O 2.5/10|||0.090|-0.046|
72464324|NCT01040403|144451386|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.051|STANDARD_ERROR_OF_MEAN|0.032|||TWO_SIDED|95.0|-0.114|0.013|||Mixed Models Analysis||Difference calculated as T+O 1.25/5 minus Olo 5|||0.013|-0.114|
72464325|NCT01040403|144451386|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.008|STANDARD_ERROR_OF_MEAN|0.032|||TWO_SIDED|95.0|-0.055|0.071|||Mixed Models Analysis||Difference calculated as T+O 2.5/5 minus Olo 5|||0.071|-0.055|
72464326|NCT01040403|144451386|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.011|STANDARD_ERROR_OF_MEAN|0.032|||TWO_SIDED|95.0|-0.074|0.053|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus Olo 5|||0.053|-0.074|
72464327|NCT01040403|144451386|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.059|STANDARD_ERROR_OF_MEAN|0.032|||TWO_SIDED|95.0|-0.004|0.122|||Mixed Models Analysis||Difference calculated as T+O 2.5/5 minus T+O 1.25/5|||0.122|-0.004|
72464328|NCT01040403|144451386|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.04|STANDARD_ERROR_OF_MEAN|0.033|||TWO_SIDED|95.0|-0.024|0.104|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus T+O 1.25/5|||0.104|-0.024|
72464329|NCT01040403|144451386|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.019|STANDARD_ERROR_OF_MEAN|0.032|||TWO_SIDED|95.0|-0.082|0.045|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus +O 2.5/5|||0.045|-0.082|
72464330|NCT01040403|144451386|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.111|STANDARD_ERROR_OF_MEAN|0.032|||TWO_SIDED|95.0|0.047|0.174|||Mixed Models Analysis||Difference calculated as T+O 1.25/10 minus Olo 10|||0.174|0.047|
72464331|NCT01040403|144451386|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.081|STANDARD_ERROR_OF_MEAN|0.032|||TWO_SIDED|95.0|0.017|0.144|||Mixed Models Analysis||Difference calculated as T+O 2.5/10 minus Olo 10|||0.144|0.017|
72464332|NCT01040403|144451386|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.069|STANDARD_ERROR_OF_MEAN|0.032|||TWO_SIDED|95.0|0.005|0.132|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus Olo 10|||0.132|0.005|
72464333|NCT01040403|144451386|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.03|STANDARD_ERROR_OF_MEAN|0.033|||TWO_SIDED|95.0|-0.094|0.034|||Mixed Models Analysis||Difference calculated as T+O 2.5/10 minus T+O 1.25/10|||0.034|-0.094|
72563953|NCT01610063|144659468|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||Comparison for QIDS-C16||||<0.0001
72563954|NCT01610063|144659469|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||t-test, 2 sided|||Comparison between groups for HAMD-17||||<0.0001
72563955|NCT01610063|144659470|OTHER|||||||0.002|||||||t-test, 2 sided|||Comparison for PHQ-9||||0.002
72563956|NCT03234608|144659541|SUPERIORITY||Slope|0.18|STANDARD_ERROR_OF_MEAN|0.32||0.56|TWO_SIDED|95.0|-0.44|0.81||The threshold for statistical significance was p\<0.05.|Regression, Linear|||||0.81|-0.44|0.56
72464334|NCT01040403|144451386|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.042|STANDARD_ERROR_OF_MEAN|0.032|||TWO_SIDED|95.0|-0.105|0.021|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus T+O 1.25/10|||0.021|-0.105|
72464335|NCT01040403|144451386|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.012|STANDARD_ERROR_OF_MEAN|0.032|||TWO_SIDED|95.0|-0.075|0.052|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus T+O 2.5/10|||0.052|-0.075|
72464336|NCT01040403|144451387|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|18.759|STANDARD_ERROR_OF_MEAN|4.189|||TWO_SIDED|95.0|10.533|26.985|||Mixed Models Analysis||Difference calculated as T+O 1.25/5 minus Olo 5|AUC 0-3h||26.985|10.533|
72464337|NCT01040403|144451387|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|25.157|STANDARD_ERROR_OF_MEAN|4.173|||TWO_SIDED|95.0|16.962|33.351|||Mixed Models Analysis||Difference calculated as T+O 2.5/5 minus Olo 5|AUC 0-3h||33.351|16.962|
72464338|NCT01040403|144451387|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|29.804|STANDARD_ERROR_OF_MEAN|4.216|||TWO_SIDED|95.0|21.526|38.082|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus Olo 5|AUC 0-3h||38.082|21.526|
72464339|NCT01040403|144451387|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.398|STANDARD_ERROR_OF_MEAN|4.173|||TWO_SIDED|95.0|-1.796|14.592|||Mixed Models Analysis||Difference calculated as T+O 2.5/5 minus T+O 1.25/5|AUC 0-3h||14.592|-1.796|
72464340|NCT01040403|144451387|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.046|STANDARD_ERROR_OF_MEAN|4.239|||TWO_SIDED|95.0|2.721|19.37|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus T+O 1.25/5|AUC 0-3h||19.370|2.721|
72502396|NCT03182738|144535391|SUPERIORITY|"Linear mixed models to test difference in mean dry mouth score from period 1 to period 3 between the two arms."|Difference in Change|-0.27||||0.08|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in dry mouth score from period 1 to period 3 between the two arms.~Negative estimation parameter value indicates intervention arm better than control arm."|"The null hypothesis is that there is no difference in change in mean dry mouth score from period 1 to period 3 between the two arms"||||0.08
72502397|NCT03182738|144535391|SUPERIORITY|"Linear mixed models to test difference in mean ringing in ear score from period 1 to period 3 between the two arms."|Difference in Change|-0.24||||0.08|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in ringing in ear score from period 1 to period 3 between the two arms.~Negative estimation parameter value indicates intervention arm better than control arm."|"The null hypothesis is that there is no difference in change in mean ringing in ear score from period 1 to period 3 between the two arms"||||0.08
72502398|NCT03182738|144535391|SUPERIORITY|"Linear mixed models to test difference in mean dry eyes score from period 1 to period 3 between the two arms."|Difference in Change|-0.24||||0.08|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in dry eyes score from period 1 to period 3 between the two arms.~Negative estimation parameter value indicates intervention arm better than control arm."|"The null hypothesis is that there is no difference in change in mean dry eyes score from period 1 to period 3 between the two arms"||||0.08
72502399|NCT03182738|144535391|SUPERIORITY|"Linear mixed models to test difference in mean maintaining an erection score from period 1 to period 3 between the two arms."|Difference in Change|-0.13||||0.71|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in maintaining an erection score from period 1 to period 3 between the two arms.~Negative estimation parameter value indicates intervention arm better than control arm."|"The null hypothesis is that there is no difference in change in mean maintaining an erection score from period 1 to period 3 between the two arms"||||0.71
72393943|NCT01059825|144294280|SUPERIORITY_OR_OTHER||Difference in least squares means|-2.15||||0|TWO_SIDED|80.0|-2.76|-1.54||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p \<0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-1.54|-2.76|0.000
72464341|NCT01040403|144451387|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.648|STANDARD_ERROR_OF_MEAN|4.204|||TWO_SIDED|95.0|-3.608|12.903|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus T+O 2.5/5|AUC 0-3h||12.903|-3.608|
72464342|NCT01040403|144451387|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|18.318|STANDARD_ERROR_OF_MEAN|4.201|||TWO_SIDED|95.0|10.068|26.568|||Mixed Models Analysis||Difference calculated as T+O 1.25/10 minus Olo 10|AUC 0-3h||26.568|10.068|
72464343|NCT01040403|144451387|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|23.511|STANDARD_ERROR_OF_MEAN|4.197|||TWO_SIDED|95.0|15.27|31.752|||Mixed Models Analysis||Difference calculated as T+O 2.5/10 minus Olo 10|AUC 0-3h||31.752|15.270|
72464344|NCT01040403|144451387|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|22.817|STANDARD_ERROR_OF_MEAN|4.214|||TWO_SIDED|95.0|14.543|31.092|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus Olo 10|AUC 0-3h||31.092|14.543|
72464345|NCT01040403|144451387|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.193|STANDARD_ERROR_OF_MEAN|4.23|||TWO_SIDED|95.0|-3.115|13.5|||Mixed Models Analysis||Difference calculated as T+O 2.5/10 minus T+O 1.25/10|AUC 0-3h||13.500|-3.115|
72464346|NCT01040403|144451387|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.499|STANDARD_ERROR_OF_MEAN|4.185|||TWO_SIDED|95.0|-3.719|12.717|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus T+O 1.25/10|AUC 0-3h||12.717|-3.719|
72464347|NCT01040403|144451387|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.694|STANDARD_ERROR_OF_MEAN|4.2|||TWO_SIDED|95.0|-8.941|7.554|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus T+O 2.5/10|AUC 0-3h||7.554|-8.941|
72464348|NCT01040403|144451387|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|18.751|STANDARD_ERROR_OF_MEAN|4.013|||TWO_SIDED|95.0|10.87|26.632|||Mixed Models Analysis||Difference calculated as T+O 1.25/5 minus Olo 5|AUC 0-6h||26.632|10.870|
72464349|NCT01040403|144451387|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|26.009|STANDARD_ERROR_OF_MEAN|3.998|||TWO_SIDED|95.0|18.158|33.86|||Mixed Models Analysis||Difference calculated as T+O 2.5/5 minus Olo 5|AUC 0-6h||33.860|18.158|
72464350|NCT01040403|144451387|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|29.347|STANDARD_ERROR_OF_MEAN|4.039|||TWO_SIDED|95.0|21.416|37.278|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus Olo 5|AUC 0-6h||37.278|21.416|
72464351|NCT01040403|144451387|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.259|STANDARD_ERROR_OF_MEAN|3.998|||TWO_SIDED|95.0|-0.592|15.109|||Mixed Models Analysis||Difference calculated as T+O 2.5/5 minus T+O 1.25/5|AUC 0-6h||15.109|-0.592|
72464352|NCT01040403|144451387|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.596|STANDARD_ERROR_OF_MEAN|4.061|||TWO_SIDED|95.0|2.621|18.571|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus T+O 1.25/5|AUC 0-6h||18.571|2.621|
72464353|NCT01040403|144451387|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.337|STANDARD_ERROR_OF_MEAN|4.028|||TWO_SIDED|95.0|-4.572|11.247|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus T+O 2.5/5|AUC 0-6h||11.247|-4.572|
72464354|NCT01040403|144451387|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|19.654|STANDARD_ERROR_OF_MEAN|4.025|||TWO_SIDED|95.0|11.75|27.558|||Mixed Models Analysis||Difference calculated as T+O 1.25/10 minus Olo 10|AUC 0-6h||27.558|11.750|
72464355|NCT01040403|144451387|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|22.762|STANDARD_ERROR_OF_MEAN|4.021|||TWO_SIDED|95.0|14.866|30.659|||Mixed Models Analysis||Difference calculated as T+O 2.5/10 minus Olo 10|AUC 0-6h||30.659|14.866|
72464356|NCT01040403|144451387|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|25.536|STANDARD_ERROR_OF_MEAN|4.038|||TWO_SIDED|95.0|17.607|33.464|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus Olo 10|AUC 0-6h||33.464|17.607|
72464357|NCT01040403|144451387|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.108|STANDARD_ERROR_OF_MEAN|4.053|||TWO_SIDED|95.0|-4.852|11.067|||Mixed Models Analysis||Difference calculated as T+O 2.5/10 minus T+O 1.25/10|AUC 0-6h||11.067|-4.852|
72464358|NCT01040403|144451387|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.881|STANDARD_ERROR_OF_MEAN|4.009|||TWO_SIDED|95.0|-1.991|13.754|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus T+O 1.25/10|AUC 0-6h||13.754|-1.991|
72502400|NCT03182738|144535391|SUPERIORITY|"Linear mixed models to test difference in mean vomit score from period 1 to period 3 between the two arms."|Difference in Change|-0.11||||0.41|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in vomit score from period 1 to period 3 between the two arms.~Negative estimation parameter value indicates intervention arm better than control arm."|"The null hypothesis is that there is no difference in change in mean vomit score from period 1 to period 3 between the two arms"||||0.41
72563957|NCT03234608|144659542|SUPERIORITY||Slope|0.28|STANDARD_ERROR_OF_MEAN|0.79||0.73|TWO_SIDED|95.0|-1.28|1.84||The threshold for statistical significance was p\<0.05.|Regression, Linear|||||1.84|-1.28|0.73
72464359|NCT01040403|144451387|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.773|STANDARD_ERROR_OF_MEAN|4.024|||TWO_SIDED|95.0|-5.129|10.675|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus T+O 2.5/10|AUC 0-6h||10.675|-5.129|
72464360|NCT01040403|144451388|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.316|STANDARD_ERROR_OF_MEAN|4.371|||TWO_SIDED|95.0|-6.268|10.9|||Mixed Models Analysis||Difference calculated as T+O 1.25/5 minus Olo 5|||10.900|-6.268|
72464361|NCT01040403|144451388|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.478|STANDARD_ERROR_OF_MEAN|4.362|||TWO_SIDED|95.0|-4.088|13.044|||Mixed Models Analysis||Difference calculated as T+O 2.5/5 minus Olo 5|||13.044|-4.088|
72464362|NCT01040403|144451388|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.668|STANDARD_ERROR_OF_MEAN|4.403|||TWO_SIDED|95.0|-3.978|13.314|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus Olo 5|||13.314|-3.978|
72464363|NCT01040403|144451388|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.162|STANDARD_ERROR_OF_MEAN|4.349|||TWO_SIDED|95.0|-6.379|10.702|||Mixed Models Analysis||Difference calculated as T+O 2.5/5 minus T+O 1.25/5|||10.702|-6.379|
72464364|NCT01040403|144451388|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.352|STANDARD_ERROR_OF_MEAN|4.419|||TWO_SIDED|95.0|-6.326|11.029|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus T+O 1.25/5|||11.029|-6.326|
72464365|NCT01040403|144451388|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.19|STANDARD_ERROR_OF_MEAN|4.39|||TWO_SIDED|95.0|-8.43|8.81|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus T+O 2.5/5|||8.810|-8.430|
72464366|NCT01040403|144451388|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.488|STANDARD_ERROR_OF_MEAN|4.392|||TWO_SIDED|95.0|-7.136|10.113|||Mixed Models Analysis||Difference calculated as T+O 1.25/10 minus Olo 10|||10.113|-7.136|
72464367|NCT01040403|144451388|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.262|STANDARD_ERROR_OF_MEAN|4.386|||TWO_SIDED|95.0|-5.35|11.875|||Mixed Models Analysis||Difference calculated as T+O 2.5/10 minus Olo 10|||11.875|-5.350|
72464368|NCT01040403|144451388|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.121|STANDARD_ERROR_OF_MEAN|4.408|||TWO_SIDED|95.0|-1.535|15.778|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus Olo 10|||15.778|-1.535|
72464369|NCT01040403|144451388|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.774|STANDARD_ERROR_OF_MEAN|4.423|||TWO_SIDED|95.0|-6.91|10.458|||Mixed Models Analysis||Difference calculated as T+O 2.5/10 minus T+O 1.25/10|||10.458|-6.910|
72464370|NCT01040403|144451388|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.663|STANDARD_ERROR_OF_MEAN|4.381|||TWO_SIDED|95.0|-2.97|14.236|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus T+O 1.25/10|||14.236|-2.970|
72563958|NCT03234608|144659543|SUPERIORITY||Slope|-0.01|STANDARD_ERROR_OF_MEAN|0.17||0.94|TWO_SIDED|95.0|-0.35|0.33||The threshold for statistical significance was p\<0.05.|Regression, Linear|||Statistical analysis for Individual Level Healthcare Self-Efficacy Sub-scale.||0.33|-0.35|0.94
72563959|NCT03234608|144659543|SUPERIORITY||Slope|0.1|STANDARD_ERROR_OF_MEAN|0.21||0.65|TWO_SIDED|95.0|-0.33|0.52|||Regression, Linear|||Statistical analysis for Relationship-Dependent Healthcare Self-Efficacy Sub-scale||0.52|-0.33|0.65
72563960|NCT03234608|144659544|SUPERIORITY||Slope|-0.23|STANDARD_ERROR_OF_MEAN|0.52||0.66|TWO_SIDED|95.0|-1.25|0.79||The threshold for statistical significance was p\<0.05.|Regression, Linear|||||0.79|-1.25|0.66
72563961|NCT03234608|144659545|SUPERIORITY||Slope|0.15|STANDARD_ERROR_OF_MEAN|0.78||0.85|TWO_SIDED|95.0|-1.4|1.69||The threshold for statistical significance was p\<0.05.|Regression, Linear|||||1.69|-1.40|0.85
72563962|NCT02105701|144659549|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||One-sided Exact Test|||The hypothesis was that at least 1 treatment arm would have a SVR12 rate \>58%.||||<0.001
72621266|NCT02732145|144773190|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of the Inner Vulvar Ring between patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of non-specific lesions of the Inner Vulvar Ring in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of vulvodynia."||||0.0000
72621267|NCT02732145|144773190|SUPERIORITY|Question: Is there a difference in the incidence of erythema of the Outer Vulvar Ring between patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of erythema of the Outer Vulvar Ring in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of vulvodynia."||||0.0000
72621268|NCT02732145|144773190|SUPERIORITY|Question: Is there a difference in the incidence of erythema of the Middle Vulvar Ring between patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of erythema of the Middle Vulvar Ring in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of vulvodynia."||||0.0000
72621269|NCT02732145|144773190|SUPERIORITY|Question: Is there a difference in the incidence of erythema of the Inner Vulvar Ring between patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of erythema of the Inner Vulvar Ring in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of vulvodynia."||||0.0000
72621270|NCT02732145|144773190|SUPERIORITY|Question: Is there a difference in the incidence of excoriations of the Outer Vulvar Ring between patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of excoriations of the Outer Vulvar Ring in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of vulvodynia."||||0.0000
72621271|NCT02732145|144773190|SUPERIORITY|Question: Is there a difference in the incidence of fissures the Middle Vulvar Ring between patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of fissures of the Middle Vulvar Ring in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of vulvodynia."||||0.0000
72621272|NCT02732145|144773190|SUPERIORITY|Question: Is there a difference in the incidence of rhagades of the Outer Vulvar Ring between patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of rhagades of the Outer Vulvar Ring in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of vulvodynia."||||0.0000
72621273|NCT02732145|144773190|SUPERIORITY|Question: Is there a difference in the frequency of smoothness of the Middle Vulvar Ring between patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of smoothness of the Middle Vulvar Ring in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of vulvodynia."||||0.0000
72621274|NCT02732145|144773190|SUPERIORITY|Question: Is there a difference in the incidence of smoothness of the Inner Vulvar Ring between patients within different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of smoothness of the Inner Vulvar Ring in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of vulvodynia."||||0.0000
72621275|NCT02732145|144773190|SUPERIORITY|Question: Is there a difference in the incidence of ischemia of the Middle Vulvar Ring between patients from different groups?||||||0.0632|||||||Chi-squared|||"Parameter: The incidence of ischemia of the Middle Vulvar Ring in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of vulvodynia."||||0.0632
72621276|NCT02732145|144773190|SUPERIORITY|Question: Is there a difference in the incidence of ischemia of the Inner Vulvar Ring between patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of ischemia of the Inner Vulvar Ring in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of vulvodynia."||||0.0000
72621277|NCT02732145|144773190|SUPERIORITY|Question: Is there a difference in the incidence of punctuation of the Middle Vulvar Ring between patients within different groups?||||||0.0043|||||||Chi-squared|||"Parameter: The incidence of punctuation of the Middle Vulvar Ring in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of vulvodynia."||||0.0043
72393944|NCT01059825|144294280|SUPERIORITY_OR_OTHER||Difference in least squares means|-1.91||||0|TWO_SIDED|80.0|-2.52|-1.3||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p \<0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-1.30|-2.52|0.000
72464371|NCT01040403|144451388|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.859|STANDARD_ERROR_OF_MEAN|4.403|||TWO_SIDED|95.0|-4.786|12.504|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus T+O 2.5/10|||12.504|-4.786|
72464372|NCT01040403|144451389|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|18.682|STANDARD_ERROR_OF_MEAN|4.849|||TWO_SIDED|95.0|9.161|28.204|||Mixed Models Analysis||Difference calculated as T+O 1.25/5 minus Olo 5|||28.204|9.161|
72464373|NCT01040403|144451389|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|23.599|STANDARD_ERROR_OF_MEAN|4.83|||TWO_SIDED|95.0|14.116|33.083|||Mixed Models Analysis||Difference calculated as T+O 2.5/5 minus Olo 5|||33.083|14.116|
72464374|NCT01040403|144451389|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|30.097|STANDARD_ERROR_OF_MEAN|4.879|||TWO_SIDED|95.0|20.517|39.677|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus Olo 5|||39.677|20.517|
72464375|NCT01040403|144451389|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.917|STANDARD_ERROR_OF_MEAN|4.83|||TWO_SIDED|95.0|-4.568|14.402|||Mixed Models Analysis||Difference calculated as T+O 2.5/5 minus T+O 1.25/5|||14.402|-4.568|
72464376|NCT01040403|144451389|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.415|STANDARD_ERROR_OF_MEAN|4.907|||TWO_SIDED|95.0|1.78|21.05|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus T+O 1.25/5|||21.050|1.780|
72502401|NCT03182738|144535391|SUPERIORITY|"Linear mixed models to test difference in mean neuropathy score from period 1 to period 3 between the two arms."|Difference in Change|-0.08||||0.84|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in neuropathy score from period 1 to period 3 between the two arms.~Negative estimation parameter value indicates intervention arm better than control arm."|"The null hypothesis is that there is no difference in change in mean neuropathy score from period 1 to period 3 between the two arms"||||0.84
72502402|NCT03182738|144535391|SUPERIORITY|"Linear mixed models to test difference in mean urination score from period 1 to period 3 between the two arms."|Difference in Change|-0.07||||0.71|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in urination score from period 1 to period 3 between the two arms.~Negative estimation parameter value indicates intervention arm better than control arm."|"The null hypothesis is that there is no difference in change in mean urination score from period 1 to period 3 between the two arms"||||0.71
72502403|NCT03182738|144535391|SUPERIORITY|"Linear mixed models to test difference in mean appetite change score from period 1 to period 3 between the two arms."|Difference in Change|-0.05||||0.88|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in appetite change score from period 1 to period 3 between the two arms.~Negative estimation parameter value indicates intervention arm better than control arm."|"The null hypothesis is that there is no difference in change in mean appetite change score from period 1 to period 3 between the two arms"||||0.88
72502404|NCT03182738|144535391|SUPERIORITY|"Linear mixed models to test difference in mean shortness of breath score from period 1 to period 3 between the two arms."|Difference in Change|-0.03||||0.93|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in shortness of breath score from period 1 to period 3 between the two arms.~Negative estimation parameter value indicates intervention arm better than control arm."|"The null hypothesis is that there is no difference in change in mean shortness of breath score from period 1 to period 3 between the two arms"||||0.93
72502405|NCT03182738|144535391|SUPERIORITY|"Linear mixed models to test difference in mean difficulty remembering score from period 1 to period 3 between the two arms."|Difference in Change|-0.03||||0.93|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in difficulty remembering score from period 1 to period 3 between the two arms.~Negative estimation parameter value indicates intervention arm better than control arm."|"The null hypothesis is that there is no difference in change in mean difficulty remembering score from period 1 to period 3 between the two arms"||||0.93
72563963|NCT02105701|144659549|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||One-sided Exact Test|||The hypothesis was that at least 1 treatment arm would have a SVR12 rate \>58%.||||<0.001
72464377|NCT01040403|144451389|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.498|STANDARD_ERROR_OF_MEAN|4.866|||TWO_SIDED|95.0|-3.057|16.053|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus T+O 2.5/5|||16.053|-3.057|
72464378|NCT01040403|144451389|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|17.742|STANDARD_ERROR_OF_MEAN|4.862|||TWO_SIDED|95.0|8.194|27.29|||Mixed Models Analysis||Difference calculated as T+O 1.25/10 minus Olo 10|||27.290|8.194|
72464379|NCT01040403|144451389|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|24.115|STANDARD_ERROR_OF_MEAN|4.856|||TWO_SIDED|95.0|14.58|33.651|||Mixed Models Analysis||Difference calculated as T+O 2.5/10 minus Olo 10|||33.651|14.580|
72464380|NCT01040403|144451389|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|25.095|STANDARD_ERROR_OF_MEAN|4.876|||TWO_SIDED|95.0|15.52|34.67|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus Olo 10|||34.670|15.520|
72464381|NCT01040403|144451389|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.373|STANDARD_ERROR_OF_MEAN|4.896|||TWO_SIDED|95.0|-3.24|15.986|||Mixed Models Analysis||Difference calculated as T+O 2.5/10 minus T+O 1.25/10|||15.986|-3.240|
72464382|NCT01040403|144451389|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.353|STANDARD_ERROR_OF_MEAN|4.845|||TWO_SIDED|95.0|-2.161|16.866|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus T+O 1.25/10|||16.866|-2.161|
72464383|NCT01040403|144451389|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.98|STANDARD_ERROR_OF_MEAN|4.861|||TWO_SIDED|95.0|-8.566|10.525|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus T+O 2.5/10|||10.525|-8.566|
72464384|NCT01040403|144451390|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.17|STANDARD_ERROR_OF_MEAN|4.853|||TWO_SIDED|95.0|-8.36|10.699|||Mixed Models Analysis||Difference calculated as T+O 1.25/5 minus Olo 5|||10.699|-8.360|
72563964|NCT02105701|144659549|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||One-sided Exact Test|||The hypothesis was that at least 1 treatment arm would have a SVR12 rate \>58%.||||<0.001
72464385|NCT01040403|144451390|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.436|STANDARD_ERROR_OF_MEAN|4.843|||TWO_SIDED|95.0|-5.073|13.945|||Mixed Models Analysis||Difference calculated as T+O 2.5/5 minus Olo 5|||13.945|-5.073|
72464386|NCT01040403|144451390|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.189|STANDARD_ERROR_OF_MEAN|4.887|||TWO_SIDED|95.0|-4.407|14.785|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus Olo 5|||14.785|-4.407|
72464387|NCT01040403|144451390|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.267|STANDARD_ERROR_OF_MEAN|4.828|||TWO_SIDED|95.0|-6.214|12.747|||Mixed Models Analysis||Difference calculated as T+O 2.5/5 minus T+O 1.25/5|||12.747|-6.214|
72464388|NCT01040403|144451390|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.02|STANDARD_ERROR_OF_MEAN|4.904|||TWO_SIDED|95.0|-5.61|13.65|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus T+O 1.25/5|||13.650|-5.610|
72464389|NCT01040403|144451390|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.753|STANDARD_ERROR_OF_MEAN|4.873|||TWO_SIDED|95.0|-8.816|10.322|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus T+O 2.5/5|||10.322|-8.816|
72464390|NCT01040403|144451390|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.986|STANDARD_ERROR_OF_MEAN|4.876|||TWO_SIDED|95.0|-6.589|12.561|||Mixed Models Analysis||Difference calculated as T+O 1.25/10 minus Olo 10|||12.561|-6.589|
72464391|NCT01040403|144451390|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.916|STANDARD_ERROR_OF_MEAN|4.868|||TWO_SIDED|95.0|-4.643|14.475|||Mixed Models Analysis||Difference calculated as T+O 2.5/10 minus Olo 10|||14.475|-4.643|
72464392|NCT01040403|144451390|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.432|STANDARD_ERROR_OF_MEAN|4.882|||TWO_SIDED|95.0|-2.154|17.019|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus Olo 10|||17.019|-2.154|
72464393|NCT01040403|144451390|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.93|STANDARD_ERROR_OF_MEAN|4.909|||TWO_SIDED|95.0|-7.708|11.568|||Mixed Models Analysis||Difference calculated as T+O 2.5/10 minus T+O 1.25/10|||11.568|-7.708|
72464394|NCT01040403|144451390|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.446|STANDARD_ERROR_OF_MEAN|4.854|||TWO_SIDED|95.0|-5.085|13.978|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus T+O 1.25/10|||13.978|-5.085|
72464395|NCT01040403|144451390|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.517|STANDARD_ERROR_OF_MEAN|4.87|||TWO_SIDED|95.0|-7.046|12.079|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus T+O 2.5/10|||12.079|-7.046|
72464396|NCT01040403|144451394|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.212|STANDARD_ERROR_OF_MEAN|0.158|||TWO_SIDED|95.0|-0.523|0.099|||Mixed Models Analysis||Difference calculated as T+O 1.25/5 minus Olo 5|Week 1||0.099|-0.523|
72464397|NCT01040403|144451394|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.319|STANDARD_ERROR_OF_MEAN|0.16|||TWO_SIDED|95.0|-0.634|-0.004|||Mixed Models Analysis||Difference calculated as T+O 2.5/5 minus Olo 5|Week 1||-0.004|-0.634|
72464398|NCT01040403|144451394|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.065|STANDARD_ERROR_OF_MEAN|0.16|||TWO_SIDED|95.0|-0.379|0.249|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus Olo 5|Week 1||0.249|-0.379|
72464399|NCT01040403|144451394|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.107|STANDARD_ERROR_OF_MEAN|0.159|||TWO_SIDED|95.0|-0.42|0.206|||Mixed Models Analysis||Difference calculated as T+O 2.5/5 minus T+O 1.25/5|Week 1||0.206|-0.420|
72464400|NCT01040403|144451394|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.147|STANDARD_ERROR_OF_MEAN|0.16|||TWO_SIDED|95.0|-0.168|0.462|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus T+O 1.25/5|Week 1||0.462|-0.168|
72464401|NCT01040403|144451394|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.255|STANDARD_ERROR_OF_MEAN|0.161|||TWO_SIDED|95.0|-0.062|0.571|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus T+O 2.5/5|Week 1||0.571|-0.062|
72464402|NCT01040403|144451394|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.042|STANDARD_ERROR_OF_MEAN|0.16|||TWO_SIDED|95.0|-0.271|0.355|||Mixed Models Analysis||Difference calculated as T+O 1.25/10 minus Olo 10|Week 1||0.355|-0.271|
72464403|NCT01040403|144451394|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.251|STANDARD_ERROR_OF_MEAN|0.159|||TWO_SIDED|95.0|-0.564|0.062|||Mixed Models Analysis||Difference calculated as T+O 2.5/10 minus Olo 10|Week 1||0.062|-0.564|
72464404|NCT01040403|144451394|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.178|STANDARD_ERROR_OF_MEAN|0.16|||TWO_SIDED|95.0|-0.492|0.135|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus Olo 10|Week 1||0.135|-0.492|
72464405|NCT01040403|144451394|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.293|STANDARD_ERROR_OF_MEAN|0.162|||TWO_SIDED|95.0|-0.611|0.024|||Mixed Models Analysis||Difference calculated as T+O 2.5/10 minus T+O 1.25/10|Week 1||0.024|-0.611|
72464406|NCT01040403|144451394|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.221|STANDARD_ERROR_OF_MEAN|0.159|||TWO_SIDED|95.0|-0.533|0.092|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus T+O 1.25/10|Week 1||0.092|-0.533|
72464407|NCT01040403|144451394|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.073|STANDARD_ERROR_OF_MEAN|0.16|||TWO_SIDED|95.0|-0.242|0.388|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus T+O 2.5/10|Week 1||0.388|-0.242|
72464408|NCT01040403|144451394|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.11|STANDARD_ERROR_OF_MEAN|0.179|||TWO_SIDED|95.0|-0.241|0.462|||Mixed Models Analysis||Difference calculated as T+O 1.25/5 minus Olo 5|Week 4||0.462|-0.241|
72464409|NCT01040403|144451394|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.092|STANDARD_ERROR_OF_MEAN|0.18|||TWO_SIDED|95.0|-0.445|0.261|||Mixed Models Analysis||Difference calculated as T+O 2.5/5 minus Olo 5|Week 4||0.261|-0.445|
72464410|NCT01040403|144451394|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.052|STANDARD_ERROR_OF_MEAN|0.18|||TWO_SIDED|95.0|-0.301|0.406|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus Olo 5|Week 4||0.406|-0.301|
72464411|NCT01040403|144451394|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.202|STANDARD_ERROR_OF_MEAN|0.179|||TWO_SIDED|95.0|-0.555|0.15|||Mixed Models Analysis||Difference calculated as T+O 2.5/5 minus T+O 1.25/5|Week 4||0.150|-0.555|
72464412|NCT01040403|144451394|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.058|STANDARD_ERROR_OF_MEAN|0.18|||TWO_SIDED|95.0|-0.411|0.296|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus T+O 1.25/5|Week 4||0.296|-0.411|
72563965|NCT02105701|144659549|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||One-sided Exact Test|||The hypothesis was that at least 1 treatment arm would have a SVR12 rate \>58%.||||<0.001
72563966|NCT02105701|144659552|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||One-sided Exact Test|||The hypothesis was that at least 1 treatment arm would have a SVR24 rate \>58%.||||<0.001
72563967|NCT02105701|144659552|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||One-sided Exact Test|||The hypothesis was that at least 1 treatment arm would have a SVR24 rate \>58%.||||<0.001
72464413|NCT01040403|144451394|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.144|STANDARD_ERROR_OF_MEAN|0.179|||TWO_SIDED|95.0|-0.208|0.496|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus T+O 2.5/5|Week 4||0.496|-0.208|
72502406|NCT03182738|144535391|SUPERIORITY|"Linear mixed models to test difference in mean muscle aches score from period 1 to period 3 between the two arms."|Difference in Change|-0.03||||0.94|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in muscle aches score from period 1 to period 3 between the two arms.~Negative estimation parameter value indicates intervention arm better than control arm."|"The null hypothesis is that there is no difference in change in mean muscle aches score from period 1 to period 3 between the two arms"||||0.94
72502407|NCT03182738|144535391|SUPERIORITY|"Linear mixed models to test difference in mean diarrhea score from period 1 to period 3 between the two arms."|Difference in Change|0.004||||0.97|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in diarrhea score from period 1 to period 3 between the two arms."|"The null hypothesis is that there is no difference in change in mean diarrhea score from period 1 to period 3 between the two arms"||||0.97
72563968|NCT02105701|144659552|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||One-sided Exact Test|||The hypothesis was that at least 1 treatment arm would have a SVR24 rate \>58%.||||<0.001
72563969|NCT02105701|144659552|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||One-sided Exact Test|||The hypothesis was that at least 1 treatment arm would have a SVR24 rate \>58%.||||<0.001
72563970|NCT00739973|144659553|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-9.97|STANDARD_ERROR_OF_MEAN|1.45|<|0.001|TWO_SIDED|95.0|-12.81|-7.12|||ANCOVA|A two-way analysis of covariance model with treatment and region as two factors, and the baseline as a covariate.||||-7.12|-12.81|<0.001
72563971|NCT00739973|144659554|SUPERIORITY_OR_OTHER||Least Square mean Difference|-4.82|STANDARD_ERROR_OF_MEAN|1.47||0.001|TWO_SIDED|95.0|-7.7|-1.94|||ANCOVA|A two-way analysis of covariance model with treatment and region as two factors, and the baseline as a covariate.||||-1.94|-7.70|0.001
72621278|NCT02732145|144773190|SUPERIORITY|Question: Is there a difference in the incidence of punctuation of the Inner Vulvar Ring between patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of punctuation of the Inner Vulvar Ring in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Typ), evaluated with Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of vulvodynia."||||0.0000
72621279|NCT02732145|144773190|SUPERIORITY|Question: Is there a difference in the incidence of papillae of the Inner Vulvar Ring between patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of papillae of the Inner Vulvar Ring in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of vulvodynia."||||0.0000
72393945|NCT01059825|144294280|SUPERIORITY_OR_OTHER||Difference in least squares means|0.45||||0.833|TWO_SIDED|80.0|-0.15|1.06||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||1.06|-0.15|0.833
72464414|NCT01040403|144451394|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.217|STANDARD_ERROR_OF_MEAN|0.179|||TWO_SIDED|95.0|-0.568|0.135|||Mixed Models Analysis||Difference calculated as T+O 1.25/10 minus Olo 10|Week 4||0.135|-0.568|
72563972|NCT00739973|144659555|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-13.85|STANDARD_ERROR_OF_MEAN|1.44|<|0.001|TWO_SIDED|95.0|-16.68|-11.0|||ANCOVA|A two-way analysis of covariance model with treatment and region as two factors, and the baseline as a covariate.||||-11.0|-16.68|<0.001
72464415|NCT01040403|144451394|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.363|STANDARD_ERROR_OF_MEAN|0.179|||TWO_SIDED|95.0|-0.714|-0.012|||Mixed Models Analysis||Difference calculated as T+O 2.5/10 minus Olo 10|Week 4||-0.012|-0.714|
72563973|NCT00739973|144659556|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-13.2|STANDARD_ERROR_OF_MEAN|1.45|<|0.001|TWO_SIDED|95.0|-16.04|-10.4|||ANCOVA|A two-way analysis of covariance model with treatment and region as two factors, and the baseline as a covariate.||||-10.4|-16.04|<0.001
72563974|NCT00739973|144659557|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-6.0|STANDARD_ERROR_OF_MEAN|0.9|<|0.001|TWO_SIDED|95.0|-7.77|-4.22|||ANCOVA|A two-way analysis of covariance model with treatment and region as two factors, and the baseline as a covariate.||||-4.22|-7.77|<0.001
72563975|NCT00739973|144659558|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-2.98|STANDARD_ERROR_OF_MEAN|0.91||0.001|TWO_SIDED|95.0|-4.77|-1.19|||ANCOVA|A two-way analysis of covariance model with treatment and region as two factors, and the baseline as a covariate.||||-1.19|-4.77|0.001
72563976|NCT00739973|144659559|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-8.63|STANDARD_ERROR_OF_MEAN|0.9|<|0.001|TWO_SIDED|95.0|-10.39|-6.87|||ANCOVA|A two-way analysis of covariance model with treatment and region as two factors, and the baseline as a covariate.||||-6.87|-10.39|<0.001
72563977|NCT00739973|144659560|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-8.17|STANDARD_ERROR_OF_MEAN|0.9|<|0.001|TWO_SIDED|95.0|-9.94|-6.4|||ANCOVA|A two-way analysis of covariance model with treatment and region as two factors, and the baseline as a covariate.||||-6.40|-9.94|<0.001
72563978|NCT00739973|144659561|SUPERIORITY_OR_OTHER||Least Sqaure Mean Difference|-2.33|STANDARD_ERROR_OF_MEAN|0.92||0.011|TWO_SIDED|95.0|-4.14|-0.53|||ANCOVA|A two-way analysis of covariance model with treatment and region as two factors, and the baseline as a covariate.||||-0.53|-4.14|0.011
72464416|NCT01040403|144451394|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.246|STANDARD_ERROR_OF_MEAN|0.179|||TWO_SIDED|95.0|-0.598|0.106|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus Olo 10|Week 4||0.106|-0.598|
72464417|NCT01040403|144451394|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.146|STANDARD_ERROR_OF_MEAN|0.182|||TWO_SIDED|95.0|-0.503|0.21|||Mixed Models Analysis||Difference calculated as T+O 2.5/10 minus T+O 1.25/10|Week 4||0.210|-0.503|
72563979|NCT00739973|144659562|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-10.81|STANDARD_ERROR_OF_MEAN|0.9|<|0.001|TWO_SIDED|95.0|-12.57|-9.05|||ANCOVA|A two-way analysis of covariance model with treatment and region as two factors, and the baseline as a covariate.||||-9.05|-12.57|<0.001
72464418|NCT01040403|144451394|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.029|STANDARD_ERROR_OF_MEAN|0.178|||TWO_SIDED|95.0|-0.379|0.321|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus T+O 1.25/10|Week 4||0.321|-0.379|
72464419|NCT01040403|144451394|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.117|STANDARD_ERROR_OF_MEAN|0.18|||TWO_SIDED|95.0|-0.235|0.47|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus T+O 2.5/10|Week 4||0.470|-0.235|
72464420|NCT01040403|144451395|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.014|STANDARD_ERROR_OF_MEAN|0.121|||TWO_SIDED|95.0|-0.223|0.25|||Mixed Models Analysis||Difference calculated as T+O 1.25/5 minus Olo 5|Day 1||0.250|-0.223|
72464421|NCT01040403|144451395|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.133|STANDARD_ERROR_OF_MEAN|0.121|||TWO_SIDED|95.0|-0.37|0.104|||Mixed Models Analysis||Difference calculated as T+O 2.5/5 minus Olo 5|Day 1||0.104|-0.370|
72464422|NCT01040403|144451395|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.039|STANDARD_ERROR_OF_MEAN|0.122|||TWO_SIDED|95.0|-0.278|0.199|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus Olo 5|Day 1||0.199|-0.278|
72464423|NCT01040403|144451395|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.147|STANDARD_ERROR_OF_MEAN|0.12|||TWO_SIDED|95.0|-0.382|0.088|||Mixed Models Analysis||Difference calculated as T+O 2.5/5 minus T+O 1.25/5|Day 1||0.088|-0.382|
72464424|NCT01040403|144451395|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.053|STANDARD_ERROR_OF_MEAN|0.121|||TWO_SIDED|95.0|-0.291|0.186|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus T+O 1.25/5|Day 1||0.186|-0.291|
72464425|NCT01040403|144451395|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.094|STANDARD_ERROR_OF_MEAN|0.121|||TWO_SIDED|95.0|-0.144|0.332|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus T+O 2.5/5|Day 1||0.332|-0.144|
72464426|NCT01040403|144451395|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.282|STANDARD_ERROR_OF_MEAN|0.121|||TWO_SIDED|95.0|-0.519|-0.045|||Mixed Models Analysis||Difference calculated as T+O 1.25/10 minus Olo 10|Day 1||-0.045|-0.519|
72464427|NCT01040403|144451395|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.113|STANDARD_ERROR_OF_MEAN|0.121|||TWO_SIDED|95.0|-0.35|0.124|||Mixed Models Analysis||Difference calculated as T+O 2.5/10 minus Olo 10|Day 1||0.124|-0.350|
72464428|NCT01040403|144451395|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.056|STANDARD_ERROR_OF_MEAN|0.12|||TWO_SIDED|95.0|-0.293|0.18|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus Olo 10|Day 1||0.180|-0.293|
72464429|NCT01040403|144451395|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.169|STANDARD_ERROR_OF_MEAN|0.121|||TWO_SIDED|95.0|-0.069|0.408|||Mixed Models Analysis||Difference calculated as T+O 2.5/10 minus T+O 1.25/10|Day 1||0.408|-0.069|
72464430|NCT01040403|144451395|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.226|STANDARD_ERROR_OF_MEAN|0.12|||TWO_SIDED|95.0|-0.01|0.461|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus T+O 1.25/10|Day 1||0.461|-0.010|
72464431|NCT01040403|144451395|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.057|STANDARD_ERROR_OF_MEAN|0.12|||TWO_SIDED|95.0|-0.18|0.293|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus T+O 2.5/10|Day 1||0.293|-0.180|
72563980|NCT00739973|144659563|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-4.79|STANDARD_ERROR_OF_MEAN|0.9|<|0.001|TWO_SIDED|95.0|-6.56|-3.03|||ANCOVA|A two-way analysis of covariance model with treatment and region as two factors, and the baseline as a covariate.||||-3.03|-6.56|<0.001
72464432|NCT01040403|144451395|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.16|STANDARD_ERROR_OF_MEAN|0.116|||TWO_SIDED|95.0|-0.067|0.387|||Mixed Models Analysis||Difference calculated as T+O 1.25/ minus Olo 5|Day 29||0.387|-0.067|
72464433|NCT01040403|144451395|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.262|STANDARD_ERROR_OF_MEAN|0.116|||TWO_SIDED|95.0|0.034|0.491|||Mixed Models Analysis||Difference calculated as T+O 2.5/5 minus Olo 5|Day 29||0.491|0.034|
72464434|NCT01040403|144451395|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.084|STANDARD_ERROR_OF_MEAN|0.118|||TWO_SIDED|95.0|-0.148|0.316|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus Olo 5|Day 29||0.316|-0.148|
72464435|NCT01040403|144451395|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.102|STANDARD_ERROR_OF_MEAN|0.115|||TWO_SIDED|95.0|-0.124|0.328|||Mixed Models Analysis||Difference calculated as T+O 2.5/5 minus T+O 1.25/5|Day 29||0.328|-0.124|
72464436|NCT01040403|144451395|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.076|STANDARD_ERROR_OF_MEAN|0.117|||TWO_SIDED|95.0|-0.306|0.154|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus T+O 1.25/5|Day 29||0.154|-0.306|
72464437|NCT01040403|144451395|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.178|STANDARD_ERROR_OF_MEAN|0.117|||TWO_SIDED|95.0|-0.408|0.052|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus T+O 2.5/5|Day 29||0.052|-0.408|
72464438|NCT01040403|144451395|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.172|STANDARD_ERROR_OF_MEAN|0.116|||TWO_SIDED|95.0|-0.056|0.4|||Mixed Models Analysis||Difference calculated as T+O 1.25/10 minus Olo 10|Day 29||0.400|-0.056|
72464439|NCT01040403|144451395|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.057|STANDARD_ERROR_OF_MEAN|0.116|||TWO_SIDED|95.0|-0.171|0.285|||Mixed Models Analysis||Difference calculated as T+O 2.5/10 minus Olo 10|Day 29||0.285|-0.171|
72464440|NCT01040403|144451395|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.118|STANDARD_ERROR_OF_MEAN|0.116|||TWO_SIDED|95.0|-0.11|0.346|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus Olo 10|Day 29||0.346|-0.110|
72464441|NCT01040403|144451395|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.115|STANDARD_ERROR_OF_MEAN|0.117|||TWO_SIDED|95.0|-0.345|0.115|||Mixed Models Analysis||Difference calculated as T+O 2.5/10 minus T+O 1.25/10|Day 29||0.115|-0.345|
72464442|NCT01040403|144451395|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.054|STANDARD_ERROR_OF_MEAN|0.116|||TWO_SIDED|95.0|-0.281|0.173|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus T+O 1.25/10|Day 29||0.173|-0.281|
72464443|NCT01040403|144451395|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.061|STANDARD_ERROR_OF_MEAN|0.116|||TWO_SIDED|95.0|-0.166|0.289|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus T+O 2.5/10|Day 29||0.289|-0.166|
72464444|NCT01040403|144451396|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.222|STANDARD_ERROR_OF_MEAN|0.132|||TWO_SIDED|95.0|-0.481|0.037|||Mixed Models Analysis||Difference calculated as T+O 1.25/5 minus Olo 5|||0.037|-0.481|
72464445|NCT01040403|144451396|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.441|STANDARD_ERROR_OF_MEAN|0.132|||TWO_SIDED|95.0|-0.7|-0.182|||Mixed Models Analysis||Difference calculated as T+O 2.5/5 minus Olo 5|||-0.182|-0.700|
72464446|NCT01040403|144451396|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.149|STANDARD_ERROR_OF_MEAN|0.133|||TWO_SIDED|95.0|-0.409|0.111|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus Olo 5|||0.111|-0.409|
72464447|NCT01040403|144451396|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.219|STANDARD_ERROR_OF_MEAN|0.132|||TWO_SIDED|95.0|-0.478|0.04|||Mixed Models Analysis||Difference calculated as T+O 2.5/5 minus T+O 1.25/5|||0.040|-0.478|
72464448|NCT01040403|144451396|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.073|STANDARD_ERROR_OF_MEAN|0.133|||TWO_SIDED|95.0|-0.189|0.335|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus T+O 1.25/5|||0.335|-0.189|
72464449|NCT01040403|144451396|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.292|STANDARD_ERROR_OF_MEAN|0.133|||TWO_SIDED|95.0|0.031|0.553|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus T+O 2.5/5|||0.553|0.031|
72464450|NCT01040403|144451396|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.382|STANDARD_ERROR_OF_MEAN|0.132|||TWO_SIDED|95.0|-0.641|-0.123|||Mixed Models Analysis||Difference calculated as T+O 1.25/10 minus Olo 10|||-0.123|-0.641|
72464451|NCT01040403|144451396|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.132|STANDARD_ERROR_OF_MEAN|0.132|||TWO_SIDED|95.0|-0.39|0.127|||Mixed Models Analysis||Difference calculated as T+O 2.5/10 minus Olo 10|||0.127|-0.390|
72464452|NCT01040403|144451396|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.326|STANDARD_ERROR_OF_MEAN|0.132|||TWO_SIDED|95.0|-0.585|-0.067|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus Olo 10|||-0.067|-0.585|
72464453|NCT01040403|144451396|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.25|STANDARD_ERROR_OF_MEAN|0.133|||TWO_SIDED|95.0|-0.01|0.511|||Mixed Models Analysis||Difference calculated as T+O 2.5/10 minus T+O 1.25/10|||0.511|-0.010|
72464454|NCT01040403|144451396|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.056|STANDARD_ERROR_OF_MEAN|0.132|||TWO_SIDED|95.0|-0.202|0.314|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus T+O 1.25/10|||0.314|-0.202|
72464455|NCT01040403|144451396|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.194|STANDARD_ERROR_OF_MEAN|0.132|||TWO_SIDED|95.0|-0.453|0.065|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus T+O 2.5/10|||0.065|-0.453|
72464456|NCT03036150|144451402|SUPERIORITY||Hazard Ratio (HR)|0.61|||<|0.0001||95.0|0.51|0.72|||Regression, Cox|Stratified by randomization stratification of Type 2 Diabetes and urine albumin creatinine ratio and adjusting for baseline eGFR.||||0.72|0.51|< 0.0001
72464457|NCT03036150|144451403|SUPERIORITY||Hazard Ratio (HR)|0.56|||<|0.0001||95.0|0.45|0.68|||Regression, Cox|Stratified by randomization stratification of Type 2 Diabetes and urine albumin creatinine ratio and adjusting for baseline eGFR.||||0.68|0.45|< 0.0001
72464458|NCT03036150|144451404|SUPERIORITY||Hazard Ratio (HR)|0.71||||0.0089||95.0|0.55|0.92|||Regression, Cox|Stratified by randomization stratification of Type 2 Diabetes and urine albumin creatinine ratio and adjusting for baseline eGFR.||||0.92|0.55|0.0089
72464459|NCT03036150|144451405|SUPERIORITY||Hazard Ratio (HR)|0.69||||0.0035||95.0|0.53|0.88|||Regression, Cox|Stratified by randomization stratification of Type 2 Diabetes and urine albumin creatinine ratio and adjusting for baseline eGFR.||||0.88|0.53|0.0035
72464460|NCT02845375|144451407|SUPERIORITY|||||||0.299|||||||ANCOVA|||||||0.299
72464461|NCT01037413|144451408|SUPERIORITY||Mean Difference (Final Values)|-14.7|||<|0.001|TWO_SIDED|95.0|-21.3|-8.1|||t-test, 2 sided|||Comparison within the participant between EXC 001 and placebo.||-8.1|-21.3|<0.001
72464462|NCT01037413|144451409|SUPERIORITY||Mean Difference (Final Values)|-14.8|||<|0.001|TWO_SIDED|95.0|-21.2|-8.3|||t-test, 2 sided|||Week 8: Comparison within the participant between EXC 001 and placebo.||-8.3|-21.2|<0.001
72464463|NCT01037413|144451409|SUPERIORITY||Mean Difference (Final Values)|-26.0|||<|0.001|TWO_SIDED|95.0|-34.3|-17.7|||t-test, 2 sided|||Week 24: Comparison within the participant between EXC 001 and placebo.||-17.7|-34.3|<0.001
72464464|NCT01037413|144451410|SUPERIORITY||Mean Difference (Final Values)|-1.2||||0.033|TWO_SIDED|95.0|-2.3|-0.1|||t-test, 2 sided|||Week 12, Vascularity: Comparison within the participant between EXC 001 and placebo.||-0.1|-2.3|0.033
72464465|NCT01037413|144451410|SUPERIORITY||Mean Difference (Final Values)|-1.1||||0.003|TWO_SIDED|95.0|-1.9|-0.4|||t-test, 2 sided|||Week 12, Pigmentation: Comparison within the participant between EXC 001 and placebo.||-0.4|-1.9|0.003
72464466|NCT01037413|144451410|SUPERIORITY||Mean Difference (Final Values)|-1.7|||<|0.001|TWO_SIDED|95.0|-2.5|-0.8|||t-test, 2 sided|||Week 12, Thickness: Comparison within the participant between EXC 001 and placebo.||-0.8|-2.5|<0.001
72464467|NCT01037413|144451410|SUPERIORITY||Mean Difference (Final Values)|-1.8|||<|0.001|TWO_SIDED|95.0|-2.7|-1.0|||t-test, 2 sided|||Week 12, Relief: Comparison within the participant between EXC 001 and placebo.||-1.0|-2.7|<0.001
72464468|NCT01037413|144451410|SUPERIORITY||Mean Difference (Final Values)|-1.1||||0.012|TWO_SIDED|95.0|-1.9|-0.3|||t-test, 2 sided|||Week 12, Pliability: Comparison within the participant between EXC 001 and placebo.||-0.3|-1.9|0.012
72464469|NCT01037413|144451410|SUPERIORITY||Mean Difference (Final Values)|-1.5||||0.003|TWO_SIDED|95.0|-2.4|-0.5|||t-test, 2 sided|||Week 12, Surface Area: Comparison within the participant between EXC 001 and placebo.||-0.5|-2.4|0.003
72464470|NCT01037413|144451410|SUPERIORITY||Mean Difference (Final Values)|-1.9|||<|0.001|TWO_SIDED|95.0|-2.6|-1.1|||t-test, 2 sided|||Week 12, Overall Opinion: Comparison within the participant between EXC 001 and placebo.||-1.1|-2.6|<0.001
72464471|NCT01037413|144451410|SUPERIORITY||Mean Difference (Final Values)|-8.4|||<|0.001|TWO_SIDED|95.0|-12.7|-4.0|||t-test, 2 sided|||Week 12, Composite Score: Comparison within the participant between EXC 001 and placebo.||-4.0|-12.7|<0.001
72464472|NCT01037413|144451410|SUPERIORITY||Mean Difference (Final Values)|-2.3|||<|0.001|TWO_SIDED|95.0|-3.2|-1.4|||t-test, 2 sided|||Week 24, Vascularity: Comparison within the participant between EXC 001 and placebo.||-1.4|-3.2|<0.001
72464473|NCT01037413|144451410|SUPERIORITY||Mean Difference (Final Values)|-1.9|||<|0.001|TWO_SIDED|95.0|-2.9|-0.9|||t-test, 2 sided|||Week 24, Pigmentation: Comparison within the participant between EXC 001 and placebo.||-0.9|-2.9|<0.001
72464474|NCT01037413|144451410|SUPERIORITY||Mean Difference (Final Values)|-1.8||||0.001|TWO_SIDED|95.0|-2.8|-0.8|||t-test, 2 sided|||Week 24, Thickness: Comparison within the participant between EXC 001 and placebo.||-0.8|-2.8|0.001
72464475|NCT01037413|144451410|SUPERIORITY||Mean Difference (Final Values)|-2.4|||<|0.001|TWO_SIDED|95.0|-3.6|-1.3|||t-test, 2 sided|||Week 24, Relief: Comparison within the participant between EXC 001 and placebo.||-1.3|-3.6|<0.001
72464476|NCT01037413|144451410|SUPERIORITY||Mean Difference (Final Values)|-2.0||||0.005|TWO_SIDED|95.0|-3.2|-0.7|||t-test, 2 sided|||Week 24, Pliability: Comparison within the participant between EXC 001 and placebo.||-0.7|-3.2|0.005
72464477|NCT01037413|144451410|SUPERIORITY||Mean Difference (Final Values)|-2.2|||<|0.001|TWO_SIDED|95.0|-3.1|-1.2|||t-test, 2 sided|||Week 24, Surface Area: Comparison within the participant between EXC 001 and placebo.||-1.2|-3.1|<0.001
72464478|NCT01037413|144451410|SUPERIORITY||Mean Difference (Final Values)|-2.4|||<|0.001|TWO_SIDED|95.0|-3.3|-1.5|||t-test, 2 sided|||Week 24, Overall Opinion: Comparison within the participant between EXC 001 and placebo.||-1.5|-3.3|<0.001
72464479|NCT01037413|144451410|SUPERIORITY||Mean Difference (Final Values)|-12.6|||<|0.001|TWO_SIDED|95.0|-17.7|-7.4|||t-test, 2 sided|||Week 24, Composite Score: Comparison within the participant between EXC 001 and placebo.||-7.4|-17.7|<0.001
72464480|NCT01037413|144451411|SUPERIORITY||Mean Difference (Final Values)|-0.6||||0.067|TWO_SIDED|95.0|-1.3|0.0|||t-test, 2 sided|||Week 12 Pain: Comparison within the participant between EXC 001 and placebo.||0.0|-1.3|0.067
72464481|NCT01037413|144451411|SUPERIORITY||Mean Difference (Final Values)|-0.3||||0.413|TWO_SIDED|95.0|-1.2|0.5|||t-test, 2 sided|||Week 12, Itching: Comparison within the participant between EXC 001 and placebo.||0.5|-1.2|0.413
72464482|NCT01037413|144451411|SUPERIORITY||Mean Difference (Final Values)|-0.5||||0.401|TWO_SIDED|95.0|-1.6|0.7|||t-test, 2 sided|||Week 12, Color: Comparison within the participant between EXC 001 and placebo.||0.7|-1.6|0.401
72464483|NCT01037413|144451411|SUPERIORITY||Mean Difference (Final Values)|-1.1||||0.083|TWO_SIDED|95.0|-2.4|0.2|||t-test, 2 sided|||Week 12, Stiffness: Comparison within the participant between EXC 001 and placebo.||0.2|-2.4|0.083
72464484|NCT01037413|144451411|SUPERIORITY||Mean Difference (Final Values)|-1.1||||0.052|TWO_SIDED|95.0|-2.3|0.0|||t-test, 2 sided|||Week 12, Thickness: Comparison within the participant between EXC 001 and placebo.||0.0|-2.3|0.052
72464485|NCT01037413|144451411|SUPERIORITY||Mean Difference (Final Values)|-1.2||||0.036|TWO_SIDED|95.0|-2.3|-0.1|||t-test, 2 sided|||Week 12, Irregular: Comparison within the participant between EXC 001 and placebo.||-0.1|-2.3|0.036
72464486|NCT01037413|144451411|SUPERIORITY||Mean Difference (Final Values)|-1.0||||0.045|TWO_SIDED|95.0|-2.1|0.0|||t-test, 2 sided|||Week 12, Overall Opinion: Comparison within the participant between EXC 001 and placebo.||-0.0|-2.1|0.045
72464487|NCT01037413|144451411|SUPERIORITY||Mean Difference (Final Values)|-4.9||||0.054|TWO_SIDED|95.0|-9.9|0.1|||t-test, 2 sided|||Week 12, Composite Score: Comparison within the participant between EXC 001 and placebo.||0.1|-9.9|0.054
72563981|NCT00739973|144659564|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-3.98|STANDARD_ERROR_OF_MEAN|0.92|<|0.001|TWO_SIDED|95.0|-5.78|-2.18|||ANCOVA|A two-way analysis of covariance model with treatment and region as two factors, and the baseline as a covariate.||||-2.18|-5.78|<0.001
72464488|NCT01037413|144451411|SUPERIORITY||Mean Difference (Final Values)|-4.0||||0.065|TWO_SIDED|95.0|-8.2|0.3|||t-test, 2 sided|||Week 12, Scar Appearance Composite Score: Comparison within the participant between EXC 001 and placebo.||0.3|-8.2|0.065
72464489|NCT01037413|144451411|SUPERIORITY||Mean Difference (Final Values)|-1.0||||0.079|TWO_SIDED|95.0|-2.0|0.1|||t-test, 2 sided|||Week 24, Pain: Comparison within the participant between EXC 001 and placebo.||0.1|-2.0|0.079
72464490|NCT01037413|144451411|SUPERIORITY||Mean Difference (Final Values)|-0.6||||0.158|TWO_SIDED|95.0|-1.5|0.3|||t-test, 2 sided|||Week 24, Itching: Comparison within the participant between EXC 001 and placebo.||0.3|-1.5|0.158
72464491|NCT01037413|144451411|SUPERIORITY||Mean Difference (Final Values)|-1.8||||0.01|TWO_SIDED|95.0|-3.0|-0.5|||t-test, 2 sided|||Week 24, Color: Comparison within the participant between EXC 001 and placebo.||-0.5|-3.0|0.010
72464492|NCT01037413|144451411|SUPERIORITY||Mean Difference (Final Values)|-2.1||||0.003|TWO_SIDED|95.0|-3.5|-0.8|||t-test, 2 sided|||Week 24, Stiffness: Comparison within the participant between EXC 001 and placebo.||-0.8|-3.5|0.003
72464493|NCT01037413|144451411|SUPERIORITY||Mean Difference (Final Values)|-2.4||||0.005|TWO_SIDED|95.0|-4.0|-0.8|||t-test, 2 sided|||Week 24, Thickness: Comparison within the participant between EXC 001 and placebo.||-0.8|-4.0|0.005
72464494|NCT01037413|144451411|SUPERIORITY||Mean Difference (Final Values)|-1.9||||0.032|TWO_SIDED|95.0|-3.5|-0.2|||t-test, 2 sided|||Week 24, Irregular: Comparison within the participant between EXC 001 and placebo.||-0.2|-3.5|0.032
72464495|NCT01037413|144451411|SUPERIORITY||Mean Difference (Final Values)|-2.3||||0.003|TWO_SIDED|95.0|-3.8|-0.9|||t-test, 2 sided|||Week 24, Overall Opinion: Comparison within the participant between EXC 001 and placebo.||-0.9|-3.8|0.003
72464496|NCT01037413|144451411|SUPERIORITY||Mean Difference (Final Values)|-9.8||||0.006|TWO_SIDED|95.0|-16.4|-3.1|||t-test, 2 sided|||Week 24, Composite Score: Comparison within the participant between EXC 001 and placebo.||-3.1|-16.4|0.006
72464497|NCT01037413|144451411|SUPERIORITY||Mean Difference (Final Values)|-8.2||||0.004|TWO_SIDED|95.0|-13.4|-3.0|||t-test, 2 sided|||Week 24, Scar Appearance Composite Score: Comparison within the participant between EXC 001 and placebo.||-3.0|-13.4|0.004
72464498|NCT05215418|144451418|OTHER|If the upper bound of the two-sided 95% confidence interval for the between-treatment group difference (VI-0521 minus placebo or phentermine) in change from baseline in 24-hr mean SBP was less than 3 mmHg, success for a non-inferiority test was claimed and the null hypothesis was rejected. If the upper bound of the two-sided 95% confidence interval was less than 0 mmHg, superiority was claimed.|||||<|0.001|||||||ANCOVA|||||||< 0.001
72464499|NCT05215418|144451418|OTHER|If the upper bound of the two-sided 95% confidence interval for the between-treatment group difference (VI-0521 minus placebo or phentermine) in change from baseline in 24-hr mean SBP was less than 3 mmHg, success for a non-inferiority test was claimed and the null hypothesis was rejected. If the upper bound of the two-sided 95% confidence interval was less than 0 mmHg, superiority was claimed.||||||0.0059|||||||ANCOVA|||||||0.0059
72464500|NCT05215418|144451418|OTHER|If the upper bound of the two-sided 95% confidence interval for the between-treatment group difference (VI-0521 minus placebo or phentermine) in change from baseline in 24-hr mean SBP was less than 3 mmHg, success for a non-inferiority test was claimed and the null hypothesis was rejected. If the upper bound of the two-sided 95% confidence interval was less than 0 mmHg, superiority was claimed.||||||0.1867|||||||ANCOVA|||||||0.1867
72563982|NCT00739973|144659565|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-9.64|STANDARD_ERROR_OF_MEAN|0.9|<|0.001|TWO_SIDED|95.0|-11.41|-7.87|||ANCOVA|A two-way analysis of covariance model with treatment and region as two factors, and the baseline as a covariate.||||-7.87|-11.41|<0.001
72563983|NCT00739973|144659566|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-6.26|STANDARD_ERROR_OF_MEAN|0.89|<|0.001|TWO_SIDED|95.0|-8.0|-4.51|||ANCOVA|A two-way analysis of covariance model with treatment and region as two factors, and the baseline as a covariate.||||-4.51|-8.00|<0.001
72393946|NCT01059825|144294281|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.42||||0.043|TWO_SIDED|80.0|-0.73|-0.11||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-0.11|-0.73|0.043
72464501|NCT05215418|144451419|OTHER|If the upper bound of the two-sided 95% confidence interval for the between-treatment group difference (VI-0521 minus placebo or phentermine) in change from baseline in 24-hr mean DBP was less than 3 mmHg, success for a non-inferiority test was claimed and the null hypothesis was rejected. If the upper bound of the two-sided 95% confidence interval was less than 0 mmHg, superiority was claimed.||||||0.0277|||||||ANCOVA|||||||0.0277
72464502|NCT05215418|144451419|OTHER|If the upper bound of the two-sided 95% confidence interval for the between-treatment group difference (VI-0521 minus placebo or phentermine) in change from baseline in 24-hr mean DBP was less than 3 mmHg, success for a non-inferiority test was claimed and the null hypothesis was rejected. If the upper bound of the two-sided 95% confidence interval was less than 0 mmHg, superiority was claimed.||||||0.0852|||||||ANCOVA|||||||0.0852
72464503|NCT05215418|144451419|OTHER|If the upper bound of the two-sided 95% confidence interval for the between-treatment group difference (VI-0521 minus placebo or phentermine) in change from baseline in 24-hr mean DBP was less than 3 mmHg, success for a non-inferiority test was claimed and the null hypothesis was rejected. If the upper bound of the two-sided 95% confidence interval was less than 0 mmHg, superiority was claimed.|||||<|0.0001|||||||ANCOVA|||||||<.0001
72464504|NCT05215418|144451420|OTHER|If the upper bound of the two-sided 95% confidence interval for the between-treatment group difference (VI-0521 minus placebo or phentermine) in change from baseline in 24-hr mean SBP was less than 3 mmHg, success for a non-inferiority test was claimed and the null hypothesis was rejected. If the upper bound of the two-sided 95% confidence interval was less than 0 mmHg, superiority was claimed.||||||0.0109|||||||ANCOVA|||In-clinic systolic blood pressure||||0.0109
72464505|NCT05215418|144451420|OTHER|If the upper bound of the two-sided 95% confidence interval for the between-treatment group difference (VI-0521 minus placebo or phentermine) in change from baseline in 24-hr mean SBP was less than 3 mmHg, success for a non-inferiority test was claimed and the null hypothesis was rejected. If the upper bound of the two-sided 95% confidence interval was less than 0 mmHg, superiority was claimed.||||||0.0339|||||||ANCOVA|||In-clinic systolic blood pressure||||0.0339
72464506|NCT05215418|144451420|OTHER|If the upper bound of the two-sided 95% confidence interval for the between-treatment group difference (VI-0521 minus placebo or phentermine) in change from baseline in 24-hr mean SBP was less than 3 mmHg, success for a non-inferiority test was claimed and the null hypothesis was rejected. If the upper bound of the two-sided 95% confidence interval was less than 0 mmHg, superiority was claimed.||||||0.6769|||||||ANCOVA|||In-clinic systolic blood pressure||||0.6769
72464507|NCT05215418|144451420|OTHER|If the upper bound of the two-sided 95% confidence interval for the between-treatment group difference (VI-0521 minus placebo or phentermine) in change from baseline in 24-hr mean DBP was less than 3 mmHg, success for a non-inferiority test was claimed and the null hypothesis was rejected. If the upper bound of the two-sided 95% confidence interval was less than 0 mmHg, superiority was claimed.||||||0.0082|||||||ANCOVA|||In-clinic diastolic blood pressure||||0.0082
72464508|NCT05215418|144451420|OTHER|If the upper bound of the two-sided 95% confidence interval for the between-treatment group difference (VI-0521 minus placebo or phentermine) in change from baseline in 24-hr mean DBP was less than 3 mmHg, success for a non-inferiority test was claimed and the null hypothesis was rejected. If the upper bound of the two-sided 95% confidence interval was less than 0 mmHg, superiority was claimed.||||||0.8131|||||||ANCOVA|||In-clinic diastolic blood pressure||||0.8131
72464509|NCT05215418|144451420|OTHER|If the upper bound of the two-sided 95% confidence interval for the between-treatment group difference (VI-0521 minus placebo or phentermine) in change from baseline in 24-hr mean DBP was less than 3 mmHg, success for a non-inferiority test was claimed and the null hypothesis was rejected. If the upper bound of the two-sided 95% confidence interval was less than 0 mmHg, superiority was claimed.||||||0.015|||||||ANCOVA|||In-clinic diastolic blood pressure||||0.0150
72464510|NCT00619983|144451421|SUPERIORITY|||||||0.69|||||||ANOVA|Repeated measures ANOVA||Due to failure of daily electronic diaries and exhaustion of funds, we were only able to recruit \< 30% of the number of subjects required in our power analysis.||||0.69
72464511|NCT01177137|144451422|SUPERIORITY||Slope|-2.35|STANDARD_ERROR_OF_MEAN|3.27||0.47|TWO_SIDED|95.0|-8.77|4.07||The a priori threshold for statistical significance was \<0.025 to account for two comparisons: (1) TRT versus the Standard of Care and (2) Partial TRT versus the Standard of Care.|repeated measures GEE model||Adjusted for baseline TQ value, clinic, visit, age, gender, baseline Positive and Negative Affect Schedule and State Trait Anxiety Inventory scores, with multiple imputation|||4.07|-8.77|0.47
72464512|NCT01177137|144451422|SUPERIORITY||Slope|-2.8|STANDARD_ERROR_OF_MEAN|2.78||0.31|TWO_SIDED|95.0|-8.27|2.65||The a priori threshold for statistical significance was \<0.025 to account for two comparisons: (1) TRT versus the Standard of Care and (2) Partial TRT versus the Standard of Care.|repeated measures GEE model||Adjusted for baseline TQ value, clinic, visit, age, gender, baseline Positive and Negative Affect Schedule and State Trait Anxiety Inventory scores, with multiple imputation|||2.65|-8.27|0.31
72464513|NCT01177137|144451423|SUPERIORITY||Slope|-0.14|STANDARD_ERROR_OF_MEAN|2.63||0.96|TWO_SIDED|95.0|-5.3|5.02||The a priori threshold for statistical significance was \<0.025 to account for two comparisons: (1) TRT versus the Standard of Care and (2) Partial TRT versus the Standard of Ca|repeated measures GEE model||Adjusted for baseline TFI value, clinic, visit, age, gender, baseline Positive and Negative Affect Schedule and State Trait Anxiety Inventory scores, with multiple imputation|||5.02|-5.30|0.96
72464514|NCT01177137|144451423|SUPERIORITY||Slope|2.74|STANDARD_ERROR_OF_MEAN|2.53||0.28|TWO_SIDED|95.0|-2.21|7.7||The a priori threshold for statistical significance was \<0.025 to adjust for two comparisons: (1) TRT versus the Standard of Care and (2) Partial TRT versus the Standard of Ca|repeated measures GEE model||Adjusted for baseline TFI value, clinic, visit, age, gender, baseline Positive and Negative Affect Schedule and State Trait Anxiety Inventory scores, with multiple imputation|||7.70|-2.21|0.28
72464515|NCT01177137|144451424|SUPERIORITY||Slope|0.61|STANDARD_ERROR_OF_MEAN|0.59||0.3|TWO_SIDED|95.0|-0.55|1.77||The a priori threshold for statistical significance was \<0.025 to account for two comparisons: (1) TRT versus the Standard of Care and (2) Partial TRT versus the Standard of Care.|repeated measures GEE model||Adjusted for baseline THI value, clinic, visit, age, gender, baseline Positive and Negative Affect Schedule and State Trait Anxiety Inventory scores, with multiple imputation|||1.77|-0.55|0.30
72464516|NCT01177137|144451424|SUPERIORITY||Slope|-0.62|STANDARD_ERROR_OF_MEAN|0.58||0.29|TWO_SIDED|95.0|-1.75|0.52||The a priori threshold for statistical significance was \<0.025 to account for two comparisons: (1) TRT versus the Standard of Care and (2) Partial TRT versus the Standard of Ca|repeated measures GEE model||Adjusted for baseline THI value, clinic, visit, age, gender, baseline Positive and Negative Affect Schedule and State Trait Anxiety Inventory scores, with multiple imputation|||0.52|-1.75|0.29
72464517|NCT01177137|144451426|SUPERIORITY||Slope|-0.39|STANDARD_ERROR_OF_MEAN|1.37||0.77|TWO_SIDED|95.0|-3.08|2.29||The a priori threshold for statistical significance was \<0.025 to account for two comparisons (1) TRT versus the Standard of Care and (2) Partial TRT versus the Standard of Care.|repeated measures GEE model||Adjusted for baseline TQ value, clinic, visit, age, gender, baseline Positive and Negative Affect Schedule and State Trait Anxiety Inventory scores, with multiple imputation|||2.29|-3.08|0.77
72464518|NCT01177137|144451426|SUPERIORITY||Slope|-0.6|STANDARD_ERROR_OF_MEAN|1.3||0.65|TWO_SIDED|95.0|-3.16|1.96||The a priori threshold for statistical significance was \<0.025 to account for two comparisons (1) TRT versus the Standard of Care and (2) Partial TRT versus the Standard of Care.|repeated measures GEE model||Adjusted for baseline TQ value, clinic, visit, age, gender, baseline Positive and Negative Affect Schedule and State Trait Anxiety Inventory scores, with multiple imputation|||1.96|-3.16|0.65
72464519|NCT01177137|144451427|SUPERIORITY||Slope|-0.36|STANDARD_ERROR_OF_MEAN|0.52||0.5|TWO_SIDED|95.0|-1.38|0.67||The a priori threshold for statistical significance was set at \<0.025 to account for two comparisons (1) TRT versus the Standard of Care and (2) Partial TRT versus the Standard of Care.|repeated measures GEE model||Adjusted for baseline TQ value, clinic, visit, age, gender, baseline Positive and Negative Affect Schedule and State Trait Anxiety Inventory scores, with multiple imputation|||0.67|-1.38|0.50
72464520|NCT01177137|144451427|SUPERIORITY||Slope|-0.12|STANDARD_ERROR_OF_MEAN|0.52||0.82|TWO_SIDED|95.0|-1.14|0.9||The a priori threshold for statistical significance was \<0.025 to account for two comparisons (1) TRT versus the Standard of Care and (2) Partial TRT versus the Standard of Care.|repeated measures GEE model||Adjusted for baseline TQ value, clinic, visit, age, gender, baseline Positive and Negative Affect Schedule and State Trait Anxiety Inventory scores, with multiple imputation|||0.90|-1.14|0.82
72464521|NCT01177137|144451428|SUPERIORITY||Slope|-0.38|STANDARD_ERROR_OF_MEAN|0.51||0.46|TWO_SIDED|95.0|-1.37|0.62||The a priori threshold for statistical significance was \<0.025 to account for two comparisons (1) TRT versus the Standard of Care and (2) Partial TRT versus the Standard of Care.|repeated measures GEE model||Adjusted for baseline TQ value, clinic, visit, age, gender, baseline Positive and Negative Affect Schedule and State Trait Anxiety Inventory scores, with multiple imputation.|||0.62|-1.37|0.46
72464522|NCT01177137|144451428|SUPERIORITY|The a priori threshold for statistical significance was \<0.025 to account for two comparisons (1) TRT versus the Standard of Care and (2) Partial TRT versus the Standard of Care.|Slope|-0.36|STANDARD_ERROR_OF_MEAN|0.51||0.48|TWO_SIDED|95.0|-1.35|0.64|||repeated measures GEE model||Adjusted for baseline TQ value, clinic, visit, age, gender, baseline Positive and Negative Affect Schedule and State Trait Anxiety Inventory scores, with multiple imputation|||0.64|-1.35|0.48
72464523|NCT01177137|144451429|SUPERIORITY||Slope|-0.1|STANDARD_ERROR_OF_MEAN|0.32||0.75|TWO_SIDED|95.0|-0.74|0.53||The a priori threshold for statistical significance was \<0.025 to account for two comparisons (1) TRT versus the Standard of Care and (2) Partial TRT versus the Standard of Care.|repeated measures GEE model||Adjusted for baseline TQ value, clinic, visit, age, gender, baseline Positive and Negative Affect Schedule and State Trait Anxiety Inventory scores, with multiple imputation|||0.53|-0.74|0.75
72464524|NCT01177137|144451429|SUPERIORITY||Slope|-0.87|STANDARD_ERROR_OF_MEAN|0.35||0.015|TWO_SIDED|95.0|-1.56|-0.17||The a priori threshold for statistical significance was \< 0.025 to account for two comparisons (1) TRT versus the Standard of Care and (2) Partial TRT versus the Standard of Care.|repeated measures GEE model||Adjusted for baseline TQ value, clinic, visit, age, gender, baseline Positive and Negative Affect Schedule and State Trait Anxiety Inventory scores, with multiple imputation|||-0.17|-1.56|0.015
72464525|NCT01177137|144451430|SUPERIORITY||Slope|-0.07|STANDARD_ERROR_OF_MEAN|0.39||0.85|TWO_SIDED|95.0|-0.83|0.69||The a priori threshold for statistical significance was \<0.025 to account for two comparisons (1) TRT versus the Standard of Care and (2) Partial TRT versus the Standard of Care.|repeated measures GEE model||Adjusted for baseline TQ value, clinic, visit, age, gender, baseline Positive and Negative Affect Schedule and State Trait Anxiety Inventory scores, with multiple imputation|||0.69|-0.83|0.85
72464526|NCT01177137|144451430|SUPERIORITY||Slope|-0.2|STANDARD_ERROR_OF_MEAN|0.34||0.55|TWO_SIDED|95.0|-0.86|0.46||The a priori threshold for statistical significance was \<0.025 to account for two comparisons (1) TRT versus the Standard of Care and (2) Partial TRT versus the Standard of Care.|repeated measures GEE model||Adjusted for baseline TQ value, clinic, visit, age, gender, baseline Positive and Negative Affect Schedule and State Trait Anxiety Inventory scores, with multiple imputation|||0.46|-0.86|0.55
72464527|NCT01177137|144451431|SUPERIORITY||Slope|-3.19|STANDARD_ERROR_OF_MEAN|3.1||0.3|TWO_SIDED|95.0|-9.27|2.88||The a priori threshold for statistical significance was \<0.025 to account for two comparisons (1) TRT versus the Standard of Care and (2) Partial TRT versus the Standard of Care|repeated measures GEE model||Adjusted for baseline TFI value, clinic, visit, age, gender, baseline Positive and Negative Affect Schedule and State Trait Anxiety Inventory scores, with multiple imputation|||2.88|-9.27|0.30
72464528|NCT01177137|144451431|SUPERIORITY||Slope|-0.91|STANDARD_ERROR_OF_MEAN|2.98||0.76|TWO_SIDED|95.0|-6.75|4.93||The a priori threshold for statistical significance was \<0.025 to account for two comparisons (1) TRT versus the Standard of Care and (2) Partial TRT versus the Standard of Care|repeated measures GEE model||Adjusted for baseline TFI value, clinic, visit, age, gender, baseline Positive and Negative Affect Schedule and State Trait Anxiety Inventory scores, with multiple imputation|||4.93|-6.75|0.76
72464529|NCT01177137|144451432|SUPERIORITY||Slope|3.12|STANDARD_ERROR_OF_MEAN|3.34||0.35|TWO_SIDED|95.0|-3.44|9.68||The a priori threshold for statistical significance was \<0.025 to account for two comparisons (1) TRT versus the Standard of Care and (2) Partial TRT versus the Standard of Care|repeated measures GEE model||Adjusted for baseline TFI value, clinic, visit, age, gender, baseline Positive and Negative Affect Schedule and State Trait Anxiety Inventory scores, with multiple imputation|||9.68|-3.44|0.35
72563984|NCT00739973|144659567|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-2.63|STANDARD_ERROR_OF_MEAN|0.92||0.004|TWO_SIDED|95.0|-4.42|-0.83|||ANCOVA|A two-way analysis of covariance model with treatment and region as two factors, and the baseline as a covariate.||||-0.83|-4.42|0.004
72464530|NCT01177137|144451432|SUPERIORITY||Slope|3.29|STANDARD_ERROR_OF_MEAN|3.19||0.3|TWO_SIDED|95.0|-2.96|9.54||The a priori threshold for statistical significance was \<0.025 to account for two comparisons (1) TRT versus the Standard of Care and (2) Partial TRT versus the Standard of Care.|repeated measures GEE model||Adjusted for baseline TFI value, clinic, visit, age, gender, baseline Positive and Negative Affect Schedule and State Trait Anxiety Inventory scores, with multiple imputation|||9.54|-2.96|0.30
72464531|NCT01177137|144451433|SUPERIORITY||Slope|1.41|STANDARD_ERROR_OF_MEAN|3.37||0.68|TWO_SIDED|95.0|-5.2|8.02||The a priori threshold for statistical significance was \<0.025 to account for two comparisons (1) TRT versus the Standard of Care and (2) Partial TRT versus the Standard of Care|repeated measures GEE model||Adjusted for baseline TFI value, clinic, visit, age, gender, baseline Positive and Negative Affect Schedule and State Trait Anxiety Inventory scores, with multiple imputation|||8.02|-5.20|0.68
72464532|NCT01177137|144451433|SUPERIORITY||Slope|0.94|STANDARD_ERROR_OF_MEAN|3.26||0.77|TWO_SIDED|95.0|-5.44|7.33||The a priori threshold for statistical significance was \<0.025 to account for two comparisons (1) TRT versus the Standard of Care and (2) Partial TRT versus the Standard of Care.|repeated measures GEE model||Adjusted for baseline TFI value, clinic, visit, age, gender, baseline Positive and Negative Affect Schedule and State Trait Anxiety Inventory scores, with multiple imputation|||7.33|-5.44|0.77
72464533|NCT01177137|144451434|SUPERIORITY||Slope|-3.53|STANDARD_ERROR_OF_MEAN|4.47||0.43|TWO_SIDED|95.0|-12.3|5.23||The a priori threshold for statistical significance was \<0.025 to account for two comparisons (1) TRT versus the Standard of Care and (2) Partial TRT versus the Standard of Care.|repeated measures GEE model||Adjusted for baseline TFI value, clinic, visit, age, gender, baseline Positive and Negative Affect Schedule and State Trait Anxiety Inventory scores, with multiple imputation|||5.23|-12.30|0.43
72464534|NCT01177137|144451434|SUPERIORITY||Slope|-13.7|STANDARD_ERROR_OF_MEAN|4.24||0.001|TWO_SIDED|95.0|-22.02|-5.38||The a priori threshold for statistical significance was \<0.025 to account for two comparisons (1) TRT versus the Standard of Care and (2) Partial TRT versus the Standard of Care.|repeated measures GEE model||Adjusted for baseline TFI value, clinic, visit, age, gender, baseline Positive and Negative Affect Schedule and State Trait Anxiety Inventory scores, with multiple imputation|||-5.38|-22.02|0.001
72502408|NCT03182738|144535391|SUPERIORITY|"Linear mixed models to test difference in mean fatigue score from period 1 to period 3 between the two arms."|Difference in Change|0.01||||0.95|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in fatigue score from period 1 to period 3 between the two arms."|"The null hypothesis is that there is no difference in change in mean fatigue score from period 1 to period 3 between the two arms"||||0.95
72502409|NCT03182738|144535391|SUPERIORITY|"Linear mixed models to test difference in mean anxiety score from period 1 to period 3 between the two arms."|Difference in Change|0.01||||0.95|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in anxiety score from period 1 to period 3 between the two arms."|"The null hypothesis is that there is no difference in change in mean anxiety score from period 1 to period 3 between the two arms"||||0.95
72502410|NCT03182738|144535391|SUPERIORITY|"Linear mixed models to test difference in mean constipation score from period 1 to period 3 between the two arms."|Difference in Change|0.03||||0.93|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in constipation score from period 1 to period 3 between the two arms."|"The null hypothesis is that there is no difference in change in mean constipation score from period 1 to period 3 between the two arms"||||0.93
72502411|NCT03182738|144535391|SUPERIORITY|"Linear mixed models to test difference in mean fever score from period 1 to period 3 between the two arms."|Difference in Change|0.06||||0.84|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in fever score from period 1 to period 3 between the two arms."|"The null hypothesis is that there is no difference in change in mean fever score from period 1 to period 3 between the two arms"||||0.84
72502412|NCT03182738|144535391|SUPERIORITY|"Linear mixed models to test difference in mean cough score from period 1 to period 3 between the two arms."|Difference in Change|0.07||||0.84|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in cough score from period 1 to period 3 between the two arms."|"The null hypothesis is that there is no difference in change in mean cough score from period 1 to period 3 between the two arms"||||0.84
72502413|NCT03182738|144535391|SUPERIORITY|"Linear mixed models to test difference in mean heartburn score from period 1 to period 3 between the two arms."|Difference in Change|0.11||||0.54|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in heartburn score from period 1 to period 3 between the two arms."|"The null hypothesis is that there is no difference in change in mean heartburn score from period 1 to period 3 between the two arms"||||0.54
72563985|NCT00739973|144659568|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-11.1|STANDARD_ERROR_OF_MEAN|0.89|<|0.001|TWO_SIDED|95.0|-12.85|-9.35|||ANCOVA|A two-way analysis of covariance model with treatment and region as two factors, and the baseline as a covariate.||||-9.35|-12.85|<0.001
72563986|NCT00739973|144659569|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-2.83|STANDARD_ERROR_OF_MEAN|1.48||0.056|TWO_SIDED|95.0|-5.73|-0.07|||ANCOVA|A two-way analysis of covariance model with treatment and region as two factors, and the baseline as a covariate.||||-0.07|-5.73|0.056
72563987|NCT00739973|144659570|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-17.08|STANDARD_ERROR_OF_MEAN|1.44|<|0.001||95.0|-19.91|-14.3|||ANCOVA|A two-way analysis of covariance model with treatment and region as two factors, and the baseline as a covariate.||||-14.3|-19.91|<0.001
72563988|NCT00739973|144659571|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-6.45|STANDARD_ERROR_OF_MEAN|1.45|<|0.001|TWO_SIDED|95.0|-9.29|-3.62|||ANCOVA|A two-way analysis of covariance model with treatment and region as two factors, and the baseline as a covariate.||||-3.62|-9.29|<0.001
72621280|NCT02732145|144773190|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of the Outer versus non-specific lesions of the Middle Vulvar Ring in patients with vulvar dermatosis?||||||0.0697|||||||t-test proportion|||Parameter: The difference in the incidence of non-specific lesions of the Outer versus non-specific lesions of the Middle Vulvar Ring in patients with vulvar dermatosis.||||0.0697
72393947|NCT01059825|144294281|SUPERIORITY_OR_OTHER||Difference in least squares means|-1.13||||0|TWO_SIDED|80.0|-1.44|-0.81||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p \<0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-0.81|-1.44|0.000
72393948|NCT01059825|144294281|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.9||||0|TWO_SIDED|80.0|-1.22|-0.59||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p \<0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-0.59|-1.22|0.000
72502414|NCT03182738|144535391|SUPERIORITY|"Linear mixed models to test difference in mean pain during sex score from period 1 to period 3 between the two arms."|Difference in Change|0.14||||0.13|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in pain during sex score from period 1 to period 3 between the two arms."|"The null hypothesis is that there is no difference in change in mean pain during sex score from period 1 to period 3 between the two arms"||||0.13
72393949|NCT01059825|144294281|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.87||||0|TWO_SIDED|80.0|-1.18|-0.55||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p \<0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-0.55|-1.18|0.000
72502415|NCT03182738|144535391|SUPERIORITY|"Linear mixed models to test difference in mean clumsy score from period 1 to period 3 between the two arms."|Difference in Change|0.18||||0.18|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in clumsy score from period 1 to period 3 between the two arms."|"The null hypothesis is that there is no difference in change in mean clumsy score from period 1 to period 3 between the two arms"||||0.18
72502416|NCT03182738|144535391|SUPERIORITY|"Linear mixed models to test difference in mean difficulty falling asleep score from period 1 to period 3 between the two arms."|Difference in Change|0.19||||0.29|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in difficulty falling asleep score from period 1 to period 3 between the two arms."|"The null hypothesis is that there is no difference in change in mean difficulty falling asleep score from period 1 to period 3 between the two arms"||||0.29
72502417|NCT03182738|144535391|SUPERIORITY|"Linear mixed models to test difference in mean difficulty concentrating score from period 1 to period 3 between the two arms."|Difference in Change|0.2||||0.12|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in difficulty concentrating score from period 1 to period 3 between the two arms."|"The null hypothesis is that there is no difference in change in mean difficulty concentrating score from period 1 to period 3 between the two arms"||||0.12
72502418|NCT03182738|144535391|SUPERIORITY|"Linear mixed models to test difference in mean decreased sex drive score from period 1 to period 3 between the two arms."|Difference in Change|0.24||||0.1|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in decreased sex drive score from period 1 to period 3 between the two arms."|"The null hypothesis is that there is no difference in change in mean decreased sex drive score from period 1 to period 3 between the two arms"||||0.10
72502419|NCT03182738|144535391|SUPERIORITY|"Linear mixed models to test difference in mean speech difficulties score from period 1 to period 3 between the two arms."|Difference in Change|0.25||||0.01|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in speech difficulties score from period 1 to period 3 between the two arms."|"The null hypothesis is that there is no difference in change in mean speech difficulties score from period 1 to period 3 between the two arms"||||0.01
72502420|NCT03182738|144535391|SUPERIORITY|"Linear mixed models to test difference in mean unplanned changes in weight score from period 1 to period 3 between the two arms."|Difference in Change|0.26||||0.08|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in unplanned changes in weight score from period 1 to period 3 between the two arms."|"The null hypothesis is that there is no difference in change in mean unplanned changes in weight score from period 1 to period 3 between the two arms"||||0.08
72563989|NCT00739973|144659572|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-6.0|STANDARD_ERROR_OF_MEAN|1.48|<|0.001|TWO_SIDED|95.0|-8.9|-3.11|||ANCOVA|A two-way analysis of covariance model with treatment and region asntwo factors, and the baseline as a covariate.||||-3.11|-8.90|<0.001
72563990|NCT00739973|144659573|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-15.03|STANDARD_ERROR_OF_MEAN|1.45|<|0.001|TWO_SIDED|95.0|-17.88|-12.2|||ANCOVA|||||-12.2|-17.88|<0.001
72563991|NCT00739973|144659574|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-7.82|STANDARD_ERROR_OF_MEAN|1.43|<|0.001|TWO_SIDED|95.0|-10.63|-5.02|||ANCOVA|A two-way analysis of covariance model with treatment and region as two factors, and the baseline as a covariate.||||-5.02|-10.63|<0.001
72563992|NCT00739973|144659575|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-2.16|STANDARD_ERROR_OF_MEAN|1.47||0.143|TWO_SIDED|95.0|-5.04|0.73|||ANCOVA|A two-way analysis of covariance model with treatment and region as two factors, and the baseline as a covariate.||||0.73|-5.04|0.143
72621281|NCT02732145|144773190|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of the Outer versus non-specific lesions of the Inner Vulvar Ring in patients with vulvar dermatosis?||||||0.0319|||||||t-test proportion|||Parameter: The difference in the incidence of non-specific lesions of the Outer versus non-specific lesions of the Inner Vulvar Ring in patients with vulvar dermatosis.||||0.0319
72464535|NCT01177137|144451435|SUPERIORITY||Slope|3.71|STANDARD_ERROR_OF_MEAN|3.91||0.34|TWO_SIDED|95.0|-3.96|11.38||The a priori threshold for statistical significance was \<0.025 to account for two comparisons (1) TRT versus the Standard of Care and (2) Partial TRT versus the Standard of Care.|repeated measures GEE model||Adjusted for baseline TFI value, clinic, visit, age, gender, baseline Positive and Negative Affect Schedule and State Trait Anxiety Inventory scores, with multiple imputation|||11.38|-3.96|0.34
72464536|NCT01177137|144451435|SUPERIORITY||Slope|-0.23|STANDARD_ERROR_OF_MEAN|3.82||0.95|TWO_SIDED|95.0|-7.72|7.26||The a priori threshold for statistical significance was \<0.025 to account for two comparisons (1) TRT versus the Standard of Care and (2) Partial TRT versus the Standard of Care.|repeated measures GEE model||Adjusted for baseline TFI value, clinic, visit, age, gender, baseline Positive and Negative Affect Schedule and State Trait Anxiety Inventory scores, with multiple imputation|||7.26|-7.72|0.95
72502421|NCT03182738|144535391|SUPERIORITY|"Linear mixed models to test difference in mean dizziness score from period 1 to period 3 between the two arms."|Difference in Change|0.27||||0.08|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in dizziness score from period 1 to period 3 between the two arms."|"The null hypothesis is that there is no difference in change in mean dizziness score from period 1 to period 3 between the two arms"||||0.08
72464537|NCT01177137|144451436|SUPERIORITY||Slope|-1.85|STANDARD_ERROR_OF_MEAN|3.69||0.62|TWO_SIDED|95.0|-9.07|5.38||The a priori threshold for statistical significance was \< 0.025 to account for two comparisons (1) TRT versus the Standard of Care and (2) Partial TRT versus the Standard of Care|repeated measures GEE model||Adjusted for baseline TFI value, clinic, visit, age, gender, baseline Positive and Negative Affect Schedule and State Trait Anxiety Inventory scores, with multiple imputation|||5.38|-9.07|0.62
72464538|NCT01177137|144451436|SUPERIORITY||Slope|-4.46|STANDARD_ERROR_OF_MEAN|3.58||0.21|TWO_SIDED|95.0|-11.48|2.55||The a priori threshold for statistical significance was \<0.025 to account for two comparisons (1) TRT versus the Standard of Care and (2) Partial TRT versus the Standard of Care|repeated measures GEE model||Adjusted for baseline TFI value, clinic, visit, age, gender, baseline Positive and Negative Affect Schedule and State Trait Anxiety Inventory scores, with multiple imputation|||2.55|-11.48|0.21
72464539|NCT01177137|144451437|SUPERIORITY||Slope|-0.13|STANDARD_ERROR_OF_MEAN|3.39||0.97|TWO_SIDED|95.0|-6.78|6.52||The a priori threshold for statistical significance was \<0.025 to account for two comparisons (1) TRT versus the Standard of Care and (2) Partial TRT versus the Standard of Care.|repeated measures GEE model||Adjusted for baseline TFI value, clinic, visit, age, gender, baseline Positive and Negative Affect Schedule and State Trait Anxiety Inventory scores, with multiple imputation|||6.52|-6.78|0.97
72464540|NCT01177137|144451437|SUPERIORITY||Slope|-3.02|STANDARD_ERROR_OF_MEAN|3.27||0.36|TWO_SIDED|95.0|-9.43|3.4||The a priori threshold for statistical significance was \<0.025 to account for two comparisons (1) TRT versus the Standard of Care and (2) Partial TRT versus the Standard of Care|repeated measures GEE model||Adjusted for baseline TFI value, clinic, visit, age, gender, baseline Positive and Negative Affect Schedule and State Trait Anxiety Inventory scores, with multiple imputation|||3.40|-9.43|0.36
72464541|NCT01177137|144451438|SUPERIORITY||Slope|1.24|STANDARD_ERROR_OF_MEAN|3.01||0.68|TWO_SIDED|95.0|-4.67|7.14||The a priori threshold for statistical significance was \<0.025 to account for two comparisons (1) TRT versus the Standard of Care and (2) Partial TRT versus the Standard of Care|repeated measures GEE model||Adjusted for baseline TFI value, clinic, visit, age, gender, baseline Positive and Negative Affect Schedule and State Trait Anxiety Inventory scores, with multiple imputation|||7.14|-4.67|0.68
72502422|NCT03182738|144535391|SUPERIORITY|"Linear mixed models to test difference in mean difficulty staying asleep score from period 1 to period 3 between the two arms."|Difference in Change|0.27||||0.09|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in difficulty staying asleep score from period 1 to period 3 between the two arms."|"The null hypothesis is that there is no difference in change in mean difficulty staying asleep score from period 1 to period 3 between the two arms"||||0.09
72502423|NCT03182738|144535391|SUPERIORITY|"Linear mixed models to test difference in mean depression score from period 1 to period 3 between the two arms."|Difference in Change|0.38||||0.05|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in depression score from period 1 to period 3 between the two arms."|"The null hypothesis is that there is no difference in change in mean depression score from period 1 to period 3 between the two arms"||||0.05
72502424|NCT03182738|144535392|SUPERIORITY|Linear mixed models to test difference in mean score of Fatigue PROMIS T-score from baseline to 3 months between two arms.|Difference in Change|-2.09||||0.83|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||The parameter was estimated using a difference in change in Fatigue PROMIS T-score from baseline to 3 months between two arms|The null hypothesis is that there is no difference in change in Fatigue PROMIS T-score from baseline to 3 months between two arms||||0.83
72502425|NCT03182738|144535392|SUPERIORITY|Linear mixed models to test difference in mean score of Anxiety PROMIS T-score from baseline to 3 months between two arms.|Difference in Change|-0.94||||0.83|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||The parameter was estimated using a difference in change in Anxiety PROMIS T-score from baseline to 3 months between two arms|The null hypothesis is that there is no difference in change in Anxiety PROMIS T-score from baseline to 3 months between two arms||||0.83
72563993|NCT00739973|144659576|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-16.4|STANDARD_ERROR_OF_MEAN|1.43|<|0.001|TWO_SIDED|95.0|-19.21|-13.6|||ANCOVA|A two-way analysis of covariance model with treatment and region as two factors, and the baseline as a covariate.||||-13.6|-19.21|<0.001
72464542|NCT01177137|144451438|SUPERIORITY||Slope|-3.52|STANDARD_ERROR_OF_MEAN|2.93||0.23|TWO_SIDED|95.0|-9.26|2.23||The a priori threshold for statistical significance was \<0.025 to account for two comparisons (1) TRT versus the Standard of Care and (2) Partial TRT versus the Standard of Care|repeated measures GEE model||Adjusted for baseline TFI value, clinic, visit, age, gender, baseline Positive and Negative Affect Schedule and State Trait Anxiety Inventory scores, with multiple imputation|||2.23|-9.26|0.23
72464543|NCT01177137|144451439|SUPERIORITY||Slope|-0.82|STANDARD_ERROR_OF_MEAN|1.27||0.52|TWO_SIDED|95.0|-3.3|1.66||The a priori threshold for statistical significance was \<0.025 to account for two comparisons (1) TRT versus the Standard of Care and (2) Partial TRT versus the Standard of Care.|repeated measures GEE model||Adjusted for baseline THI value, clinic, visit, age, gender, baseline Positive and Negative Affect Schedule and State Trait Anxiety Inventory scores, with multiple imputation|||1.66|-3.30|0.52
72464544|NCT01177137|144451439|SUPERIORITY||Slope|-2.81|STANDARD_ERROR_OF_MEAN|1.22||0.022|TWO_SIDED|95.0|-5.21|-0.41||The a priori threshold for statistical significance was \<0.025 to account for two comparisons (1) TRT versus the Standard of Care and (2) Partial TRT versus the Standard of Care|repeated measures GEE model||Adjusted for baseline THI value, clinic, visit, age, gender, baseline Positive and Negative Affect Schedule and State Trait Anxiety Inventory scores, with multiple imputation|||-0.41|-5.21|0.022
72464545|NCT01177137|144451440|SUPERIORITY||Slope|0.34|STANDARD_ERROR_OF_MEAN|0.96||0.72|TWO_SIDED|95.0|-1.54|2.23||The a priori threshold for statistical significance was \<0.025 to account for two comparisons (1) TRT versus the Standard of Care and (2) Partial TRT versus the Standard of Care|repeated measures GEE model||Adjusted for baseline THI value, clinic, visit, age, gender, baseline Positive and Negative Affect Schedule and State Trait Anxiety Inventory scores, with multiple imputation|||2.23|-1.54|0.72
72464546|NCT01177137|144451440|SUPERIORITY||Slope|-1.04|STANDARD_ERROR_OF_MEAN|0.91||0.26|TWO_SIDED|95.0|-2.83|0.75||The a priori threshold for statistical significance was \<0.025 to account for two comparisons (1) TRT versus the Standard of Care and (2) Partial TRT versus the Standard of Care|repeated measures GEE model||Adjusted for baseline THI value, clinic, visit, age, gender, baseline Positive and Negative Affect Schedule and State Trait Anxiety Inventory scores, with multiple imputation|||0.75|-2.83|0.26
72464547|NCT01177137|144451441|SUPERIORITY||Slope|0.61|STANDARD_ERROR_OF_MEAN|0.59||0.3|TWO_SIDED|95.0|0.55|1.78||The a priori threshold for statistical significance was \<0.025 to account for two comparisons (1) TRT versus the Standard of Care and (2) Partial TRT versus the Standard of Care|repeated measures GEE model||Adjusted for baseline THI value, clinic, visit, age, gender, baseline Positive and Negative Affect Schedule and State Trait Anxiety Inventory scores, with multiple imputation|||1.78|0.55|0.30
72621282|NCT02732145|144773190|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of Middle versus non-specific lesions of the Inner Vulvar Ring in patients with vulvar dermatosis?||||||0.7273|||||||t-test proportion|||Parameter: The difference in the incidence of non-specific lesions of Middle versus non-specific lesions of the Inner Vulvar Ring in patients with vulvar dermatosis.||||0.7273
72621283|NCT02732145|144773190|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of the Outer versus non-specific lesions of the Middle Vulvar Ring in patients with vulvodynia?||||||0|||||||t-test proportion|||"Parameter: The difference in the incidence of non-specific lesions of the Outer versus non-specific lesions of the Middle Vulvar Ring in patients with vulvodynia.~The diagnosis of vulvodynia was based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection, Q-Tip) following Friedrich's criteria. Vulvoscopic lesions were not relevant to the diagnosis of vulvodynia."||||0.0000
72621284|NCT02732145|144773190|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of the Outer versus non-specific lesions of the Middle Vulvar Ring in patients with vulvodynia?||||||0|||||||t-test proportion|||"Parameter: The difference in the incidence of non-specific lesions of the Outer versus non-specific lesions of the Inner Vulvar Ring in patients with vulvodynia.~The diagnosis of vulvodynia was based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection, Q-Tip) following Friedrich's criteria. Vulvoscopic lesions were not relevant to the diagnosis of vulvodynia."||||0.0000
72621285|NCT02732145|144773190|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of the Middle versus non-specific lesions of the Inner Vulvar Ring in patients with vulvodynia?||||||0.2203|||||||t-test proportion|||"Parameter: The difference in the incidence of non-specific lesions of the Middle versus non-specific lesions of the Inner Vulvar Ring in patients with vulvodynia.~The diagnosis of vulvodynia was based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection, Q-Tip) following Friedrich's criteria. Vulvoscopic lesions were not relevant to the diagnosis of vulvodynia."||||0.2203
72621286|NCT02732145|144773190|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of Outer versus non-specific lesions of the Middle Vulvar Ring in patients with impaired vulvar skin?||||||0|||||||t-test proportion|||Parameter: The difference in the incidence of non-specific lesions of the Outer versus non-specific lesions of the Middle Vulvar Ring in patients with impaired vulvar skin.||||0.0000
72464548|NCT01177137|144451441|SUPERIORITY||Slope|-0.62|STANDARD_ERROR_OF_MEAN|0.58||0.29|TWO_SIDED|95.0|-1.75|0.52||The a priori threshold for statistical significance was \<0.025 to account for two comparisons (1) TRT versus the Standard of Care and (2) Partial TRT versus the Standard of Care|repeated measures GEE model||Adjusted for baseline THI value, clinic, visit, age, gender, baseline Positive and Negative Affect Schedule and State Trait Anxiety Inventory scores, with multiple imputation|||0.52|-1.75|0.29
72621287|NCT02732145|144773190|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of Outer versus non-specific lesions of the Inner Vulvar Ring in patients with impaired vulvar skin?||||||0|||||||t-test proportion|||Parameter: The difference in the incidence of non-specific lesions of the Outer versus non-specific lesions of the Inner Vulvar Ring in patients with impaired vulvar skin.||||0.0000
72621288|NCT02732145|144773190|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of the Middle versus non-specific lesions of the Inner Vulvar Ring in patients with impaired vulvar skin?||||||0.1456|||||||t-test proportion|||Parameter: The incidence of non-specific lesions of the Middle versus non-specific lesions of the Inner Vulvar Ring in patients with impaired vulvar skin.||||0.1456
72502426|NCT03182738|144535392|SUPERIORITY|Linear mixed models to test difference in mean score of Depression PROMIS T-score from baseline to 3 months between two arms.|Difference in Change|-0.79||||0.83|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||The parameter was estimated using a difference in change in Depression PROMIS T-score from baseline to 3 months between two arms|The null hypothesis is that there is no difference in change in Depression PROMIS T-score from baseline to 3 months between two arms||||0.83
72464549|NCT02460562|144451460|SUPERIORITY||||||<|0.05||||||Mean salivary fluoride concentrations (part per million) between groups were assessed at different time points using repeated measures analysis of variance. Saliva fluoride concentration from each groups were compared with baseline using a t-test.|ANOVA|||Mean saliva fluoride concentration (part per million) collected at different time points was compared in order to assess the change in capacity for fluoride release and recharge from the resin denture base and to assess differences between the control and the intervention group.||||<0.05
72464550|NCT02460562|144451461|SUPERIORITY||Odds Ratio (OR)|0.45|||<|0.05|TWO_SIDED|95.0|||||Chi-squared|||Caries assessments were performed to examine the difference in mean number of surface caries (DMFS) ± standard deviation between the control and the intervention groups at baseline and at 1.5 years.The transition (∆Q) of developed new caries surfaces (ICDAS score 1-3) from baseline to 1.5 years of follow-up for the two groups was analyzed with respect to arrest or progress rates. Numbers of new caries surfaces were compared by independent t-test, Pearson chi-square and correlation coefficient.||||<0.05
72464551|NCT00187135|144451479|SUPERIORITY_OR_OTHER|||||||0.5||95.0||||To adjust for multiple comparisons, p-values less than 0.0167 are considered statistically significant.|McNemar|||The study was designed to achieve statistical power of 80% for this comparison. Due to the early termination of the study, the sample size needed to ensure adequate statistical power for this comparison was not obtained.||||0.5
72464552|NCT00187135|144451479|SUPERIORITY_OR_OTHER|||||||0.5||95.0||||To adjust for multiple comparisons, p-values less than 0.0167 are considered statistically significant.|McNemar|||The study was designed to achieve statistical power of 80% for this comparison. The sample size needed to ensure adequate statistical power for this comparison was obtained.||||0.5
72464553|NCT00187135|144451480|SUPERIORITY_OR_OTHER|||||||0.5||95.0||||To adjust for multiple comparisons, p-values less than 0.0167 are considered statistically significant.|McNemar|||The study was designed to achieve statistical power of 80% for this comparison. Due to the early termination of the study, the sample size needed to ensure adequate statistical power for this comparison was not obtained.||||0.5
72464554|NCT00187135|144451481|SUPERIORITY_OR_OTHER|||||||0.87||95.0|||||GEE Model|||The generalized estimation equation (GEE) approach by Liang and Zeger was used to model the effects of 20% change in heart rate (HR) on pain (Y/N) while controlling for treatment.||||0.87
72464555|NCT00187135|144451482|SUPERIORITY_OR_OTHER|||||||0.67||95.0|||||GEE Model|||The generalized estimation equation (GEE) approach by Liang and Zeger was used to model the effects of 20% change in respiratory rate (RR) on pain (Y/N) while controlling for treatment.||||0.67
72464556|NCT00187135|144451483|SUPERIORITY_OR_OTHER|||||||0.52||95.0|||||GEE Model|||The generalized estimation equation (GEE) approach by Liang and Zeger was used to model the effects of 20% change in blood presure (BP) on pain (Y/N) while controlling for treatment.||||0.52
72464557|NCT00187135|144451484|SUPERIORITY_OR_OTHER|||||||0.99||95.0|||||GEE Model|||The generalized estimation equation (GEE) approach by Liang and Zeger was used to model the effects of motion (Y/N)on pain (Y/N) while controlling for treatment.||||0.99
72464558|NCT01287416|144451485|SUPERIORITY_OR_OTHER|||||||0.61||95.0||||The a priori threshold for statistical significance was set at p\<.05. Effect size determined by partial eta-squared to be 0.01.|Mixed Models Analysis|Model was adjusted for differences in educational attainment at baseline.||The null hypothesis was that the groups would not differ in terms of SIRI scores across the three time points. We used linear mixed models to determine whether scores were different between the two groups over time.||||0.61
72464559|NCT01287416|144451486|SUPERIORITY_OR_OTHER|||||||0.95||95.0||||The a priori threshold for statistical significance was set at p\<.05. Effect size determined by partial eta-squared to be 0.02.|Mixed Models Analysis|Model was adjusted for differences in educational attainment at baseline.||The null hypothesis was that the groups would not differ in terms of level of knowledge across the three time points.||||0.95
72464560|NCT01287416|144451487|SUPERIORITY_OR_OTHER|||||||0.33||95.0||||The a priori threshold for statistical significance was set at p\<.05. Effect size determined by partial eta-squared to be 0.02.|Mixed Models Analysis|Model was adjusted for differences in educational attainment at baseline.||The null hypothesis was that the two groups would not differ in terms of self-reported skill level across the three time points.||||0.33
72464561|NCT01287416|144451488|SUPERIORITY_OR_OTHER|||||||0.03||95.0||||The a priori threshold for statistical significance was set at p\<.05. Effect size determined by partial eta-squared to be 0.05.|Mixed Models Analysis|Model adjusted for differences in educational attainment at baseline.||The null hypothesis was that the groups would not differ in terms of level of knowledge across the three time points.||||0.03
72464562|NCT01287416|144451489|SUPERIORITY_OR_OTHER|||||||0.63||95.0||||The a priori threshold for statistical significance was set at p\<.05. Effect size determined by partial eta-squared to be 0.01.|Mixed Models Analysis|Model was adjusted for differences in educational attainment at baseline.||The null hypothesis was that the two groups would not differ on level of self-reported preparedness to help a suicidal person.||||0.63
72464563|NCT01287416|144451490|SUPERIORITY_OR_OTHER|||||||0.21||95.0||||A priori threshold for significance set to p\<.05.|ANCOVA|Model adjusted for differences in educational attainment at baseline.||The null hypothesis was that the groups would not differ on their level of distress across the two time points.||||0.21
72464564|NCT01287416|144451491|SUPERIORITY_OR_OTHER|||||||0.46||95.0||||A priori threshold for significance set at p\<.05.|ANCOVA|Model was adjusted for differences in educational attainment at baseline.||Null hypothesis was that the groups would not differ in terms of alcohol use across the two time points.||||0.46
72464565|NCT01287416|144451492|SUPERIORITY_OR_OTHER|||||||0.28||95.0||||The a priori threshold for statistical significance was set at p\<.05.|ANCOVA|Model is adjusted for differences in educational attainment at baseline.||The null hypothesis was that the two groups would not differ in resiliency scores across the follow-up period.||||0.28
72464566|NCT01287416|144451493|SUPERIORITY_OR_OTHER|||||||0.33||95.0||||A priori threshold for significance set at p\<.05.|Chi-squared|||||||0.33
72464567|NCT01287416|144451494|SUPERIORITY_OR_OTHER|||||||0.62||95.0||||A priori threshold for significance set at p\<.05.|Chi-squared|||||||0.62
72464568|NCT01287416|144451495|SUPERIORITY_OR_OTHER|||||||1||95.0||||A priori threshold for significance set to p\<.05.|Fisher Exact|||||||1.00
72464569|NCT01287416|144451496|SUPERIORITY_OR_OTHER|||||||1||95.0||||A priori threshold for significance set to p\<.05.|Fisher Exact|||||||1.00
72464570|NCT01287416|144451497|SUPERIORITY_OR_OTHER|||||||0.064||95.0||||A priori threshold for significance set to p\<.05.|Fisher Exact|||||||0.064
72464571|NCT01287416|144451499|SUPERIORITY_OR_OTHER|||||||0.14||95.0||||a priori threshold for significance set a p\<.05.|Fisher Exact|unadjusted model||Null hypothesis was that the groups would not differ in terms of their gatekeeper behaviours||||0.14
72464572|NCT01287416|144451500|SUPERIORITY_OR_OTHER|||||||0.41||95.0||||A priori threshold for significance set at p\<.05.|Chi-squared|Unadjusted model||Null hypothesis was that the groups would not differ on gatekeeper behaviours.||||0.41
72464573|NCT01196741|144451534|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.89||||0.57|TWO_SIDED|95.0|0.65|1.23|||Regression, Cox|||||1.23|0.65|0.57
72464574|NCT01196741|144451535|SUPERIORITY_OR_OTHER|||||||0.81|||||||Regression, Cox|||||||0.81
72621289|NCT02732145|144773190|SUPERIORITY|Question: Is there a difference in the incidence of specific lesions of the Outer versus specific lesions of the Middle Vulvar Ring in patients with vulvar dermatosis?||||||0.1133|||||||t-test proportion|||Parameter: The difference in the incidence of specific lesions of the Outer versus specific lesions of the Middle Vulvar Ring in patients with vulvar dermatosis.||||0.1133
72621290|NCT02732145|144773190|SUPERIORITY|Question: Is there a difference in the incidence of specific lesions of the Outer versus specific lesions of the Inner Vulvar Ring in patients with vulvar dermatosis?||||||0|||||||t-test proportion|||Parameter: The difference in the incidence of specific lesions of the Outer versus specific lesions of the Inner Vulvar Ring in patients with vulvar dermatosis.||||0.0000
72464575|NCT01196741|144451538|SUPERIORITY_OR_OTHER|||||||0.0476|||||||Mixed Models Analysis|||||||0.0476
72464576|NCT01196741|144451540|SUPERIORITY_OR_OTHER|||||||0.99|||||||Regression, Cox|||||||0.99
72464577|NCT02825849|144451551|SUPERIORITY|||||||0.824|||||||Chi-squared|||||||.824
72464578|NCT02273180|144451555|NON_INFERIORITY|Non-inferiority of SAR342434 over Humalog was demonstrated if upper bound of 2-sided 95% confidence interval(CI) of difference between SAR342434 \& Humalog was \<0.3%.Inverse non-inferiority of Humalog over SAR342434 was tested using hierarchical step-down testing procedure:if non-inferiority of SAR342434 over Humalog was demonstrated,then inverse non-inferiority of Humalog over SAR342434 was tested, demonstrated if lower bound of 2-sided 95%CI of difference between SAR342434 \& Humalog was \>-0.3%.|Least Square (LS) Mean Difference|0.06|STANDARD_ERROR_OF_MEAN|0.071|||TWO_SIDED|95.0|-0.084|0.197|||||SAR342434 vs. Humalog|Analysis was performed using a MMRM approach with treatment groups, randomization strata, visits and treatment-by-visit interaction as fixed categorical effects, and baseline HbA1c value and baseline HbA1c value-by-visit interaction as continuous fixed covariates. An unstructured correlation matrix was used to model within-participant errors.||0.197|-0.084|
72464579|NCT05294328|144451611|SUPERIORITY||Odds Ratio (OR)|34.262|||<|0.0001|TWO_SIDED||||||Generalized Estimating Equation (GEE)|||||||<0.0001
72464580|NCT05294328|144451611|SUPERIORITY||Odds Ratio (OR)|73.443|||<|0.0001|TWO_SIDED||||||Generalized Estimating Equation (GEE)|||||||<0.0001
72464581|NCT02056873|144451612|SUPERIORITY||Mean Difference (Final Values)|0.3||||0.05|ONE_SIDED||||||Wilcoxon (Mann-Whitney)|||"At 6 months post-surgery the YGTSS scores of each subjects is statistically tested against their baseline scores.~A decrease in this tic severity scale means that the severity of the tics have reduced.~Hence, we performed a superiority test, which statistically verifies if the reduction in the tic severity scale was meaningful."||||0.05
72464582|NCT00552513|144451614|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.85||||0.15|TWO_SIDED|95.0|0.68|1.06|||Regression, Logistic|||||1.06|0.68|0.15
72464583|NCT00552513|144451615|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.72||||0.003|TWO_SIDED|95.0|0.58|0.89|||Regression, Logistic|||||0.89|0.58|0.003
72464584|NCT00552513|144451616|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.84||||0.04|TWO_SIDED|95.0|0.71|0.99|||Regression, Logistic|||||0.99|0.71|0.04
72464585|NCT03712449|144451626|OTHER|The data was analyzed using Paired t-test. If normality was not met, then the Wilcoxon signed-rank test was used.||||||0.0009|||||||Paired t-test/Wilcoxon Signed Rank Test|||||||0.0009
72464586|NCT03712449|144451626|OTHER|The data was analyzed using Paired t-test. If normality was not met, then the Wilcoxon signed-rank test was used.|||||<|0.0001|||||||Paired t-test/Wilcoxon Signed Rank Test|||||||<0.0001
72464587|NCT03712449|144451627|OTHER|The data was analyzed using Paired t-test. If normality was not met, then the Wilcoxon signed-rank test was used.||||||0.7878|||||||Paired t-test/Wilcoxon Signed Rank Test|||||||0.7878
72464588|NCT03712449|144451627|OTHER|The data was analyzed using Paired t-test. If normality was not met, then the Wilcoxon signed-rank test was used.||||||0.0349|||||||Paired t-test/Wilcoxon Signed Rank Test|||||||0.0349
72464589|NCT03712449|144451628|OTHER|The data was analyzed using Paired t-test. If normality was not met, then the Wilcoxon signed-rank test was used.||||||0.0043|||||||Paired t-test/Wilcoxon Signed Rank Test|||||||0.0043
72464590|NCT03712449|144451628|OTHER|The data was analyzed using Paired t-test. If normality was not met, then the Wilcoxon signed-rank test was used.|||||<|0.0001|||||||Paired t-test/Wilcoxon Signed Rank Test|||||||<0.0001
72464591|NCT03712449|144451629|OTHER|The data was analyzed using Paired t-test. If normality was not met, then the Wilcoxon signed-rank test was used.||||||0.0017|||||||Paired t-test/Wilcoxon Signed Rank Test|||||||0.0017
72464592|NCT03712449|144451629|OTHER|The data was analyzed using Paired t-test. If normality was not met, then the Wilcoxon signed-rank test was used.|||||<|0.0001|||||||Paired t-test/Wilcoxon Signed Rank Test|||||||<0.0001
72464593|NCT03712449|144451630|OTHER|The data was analyzed using Paired t-test. If normality was not met, then the Wilcoxon signed-rank test was used.||||||0.0105|||||||Paired t-test/Wilcoxon Signed Rank Test|||||||0.0105
72464594|NCT03712449|144451630|OTHER|The data was analyzed using Paired t-test. If normality was not met, then the Wilcoxon signed-rank test was used.|||||<|0.0001|||||||Paired t-test/Wilcoxon Signed Rank Test|||||||<0.0001
72464595|NCT03712449|144451631|OTHER|The data was analyzed using Paired t-test. If normality was not met, then the Wilcoxon signed-rank test was used.||||||0.0004|||||||Paired t-test/Wilcoxon Signed Rank Test|||||||0.0004
72464596|NCT03712449|144451631|OTHER|The data was analyzed using Paired t-test. If normality was not met, then the Wilcoxon signed-rank test was used.|||||<|0.0001|||||||Paired t-test/Wilcoxon Signed Rank Test|||||||<.0001
72464597|NCT03712449|144451636|OTHER|The data was analyzed using Paired t-test. If normality was not met, then the Wilcoxon signed-rank test was used.||||||0.0005|||||||Paired t-test/Wilcoxon Signed Rank Test|||||||0.0005
72464598|NCT03712449|144451636|OTHER|The data was analyzed using Paired t-test. If normality was not met, then the Wilcoxon signed-rank test was used.|||||<|0.0001|||||||Paired t-test/Wilcoxon Signed Rank Test|||||||<0.0001
72464599|NCT02747121|144451660|OTHER|The intervention was external inspections. This is an organizational level intervention and it does not replace any existing intervention.|Odds Ratio (OR)|1.25||||0.24|TWO_SIDED|95.0|0.86|1.8||We used calculated P-values, however only confidence intervals were reported in the published article.|Mixed Models Analysis|||||1.80|0.86|0.24
72502427|NCT03182738|144535392|SUPERIORITY|Linear mixed models to test difference in mean score of Pain Interference PROMIS T-score from baseline to 3 months between two arms.|Difference in Change|-0.78||||0.83|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||The parameter was estimated using a difference in change in Pain Interference PROMIS T-score from baseline to 3 months between two arms|The null hypothesis is that there is no difference in change in Pain Interference PROMIS T-score from baseline to 3 months between two arms||||0.83
72502428|NCT03182738|144535392|SUPERIORITY|Linear mixed models to test difference in mean score of Satisfaction with Social Role PROMIS T-score from baseline to 3 months between two arms.|Difference in Change|0.04||||0.98|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in Satisfaction with Social Role PROMIS T-score from baseline to 3 months between two arms.~Positive estimation parameter value indicates intervention arm better than control arm"|The null hypothesis is that there is no difference in change in Satisfaction with Social Role PROMIS T-score from baseline to 3 months between two arms||||0.98
72563994|NCT03078478|144659580|SUPERIORITY||Treatment rate ratio|0.88||||0.1715|TWO_SIDED|95.0|0.73|1.06|||Regression, Cox|||The number of episodes is analysed using a negative binomial regression model (log link) with the logarithm of the time period in which a hypoglycaemic episode was considered treatment emergent as offset. The model includes treatment, number of OADs, region, sex and dosing time as fixed factors, and age as a covariate. Missing values are imputed through multiple imputation by treatment arm, based on a Poisson model.||1.06|0.73|0.1715
72621291|NCT02732145|144773190|SUPERIORITY|Question: Is there a difference in the incidence of specific lesions of the Middle versus specific lesions of the Inner Vulvar Ring in patients with vulvar dermatosis?||||||0.0058|||||||t-test proportion|||Parameter: The difference in the incidence of specific lesions of the Middle versus specific lesions of the Inner Vulvar Ring in patients with vulvar dermatosis.||||0.0058
72464600|NCT03029234|144451664|OTHER|The prespecified threshold that the primary endpoint would be met was if the lower limit of the 95% confidence interval (CI) was greater than 18%.|Overall response rate|35.8|||||TWO_SIDED|95.0|27.3|44.9||||||||44.9|27.3|
72464601|NCT02166047|144451686|SUPERIORITY||Least Squares (LS) Mean Difference|0.023||||0.59|TWO_SIDED|95.0|-0.061|0.108||P-value between vesatolimod and placebo was not adjusted for multiplicity due to exploratory nature of the study.|MMRM|||||0.108|-0.061|0.590
72464602|NCT02166047|144451686|SUPERIORITY||LS Mean Difference|0.068||||0.12|TWO_SIDED|95.0|-0.018|0.154||P-value between vesatolimod and placebo was not adjusted for multiplicity due to exploratory nature of the study.|MMRM|||||0.154|-0.018|0.120
72464603|NCT02166047|144451686|SUPERIORITY||LS Mean Difference|0.017||||0.701|TWO_SIDED|95.0|-0.069|0.102||P-value between vesatolimod and placebo was not adjusted for multiplicity due to exploratory nature of the study.|MMRM|||||0.102|-0.069|0.701
72563995|NCT02339090|144659599|NON_INFERIORITY|Threshold for significance: annualized height velocity between somavaratan and daily rhGH ≤ -2.0 cm/year|LS Mean Difference|-1.28|||||TWO_SIDED|95.0|-2.32|-0.24||||||An ANCOVA model will be used to determine the adjusted (least squares) means and standard error (SE) to determine the confidence interval (CI) of the difference. ANCOVA model included treatment group, region, and gender as fixed effects; with baseline age and baseline IGF-I SDS as covariates.||-0.24|-2.32|
72621292|NCT02732145|144773191|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of Mons Pubis among patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of non-specific lesions of Mons pubis in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant for the diagnosis of the vulvodynia."||||0.0000
72464604|NCT02166047|144451686|SUPERIORITY||LS Mean Difference|0.082||||0.21|TWO_SIDED|95.0|-0.046|0.21||P-value between vesatolimod and placebo was not adjusted for multiplicity due to exploratory nature of the study.|MMRM|||||0.210|-0.046|0.210
72464605|NCT02166047|144451686|SUPERIORITY||LS Mean Difference|0.082||||0.207|TWO_SIDED|95.0|-0.046|0.21||P-value between vesatolimod and placebo was not adjusted for multiplicity due to exploratory nature of the study.|MMRM|||||0.210|-0.046|0.207
72464606|NCT02166047|144451686|SUPERIORITY||LS Mean Difference|0.081||||0.216|TWO_SIDED|95.0|-0.048|0.21||P-value between vesatolimod and placebo was not adjusted for multiplicity due to exploratory nature of the study.|MMRM|||||0.210|-0.048|0.216
72464607|NCT02166047|144451686|SUPERIORITY||LS Mean Difference|-0.015||||0.652|TWO_SIDED|95.0|-0.081|0.051||P-value between vesatolimod and placebo was not adjusted for multiplicity due to exploratory nature of the study.|MMRM|||||0.051|-0.081|0.652
72464608|NCT02166047|144451686|SUPERIORITY||LS Mean Difference|0.0||||0.994|TWO_SIDED|95.0|-0.066|0.065||P-value between vesatolimod and placebo was not adjusted for multiplicity due to exploratory nature of the study.|MMRM|||||0.065|-0.066|0.994
72464609|NCT02166047|144451686|SUPERIORITY||LS Mean Difference|0.0||||0.996|TWO_SIDED|95.0|-0.069|0.069||P-value between vesatolimod and placebo was not adjusted for multiplicity due to exploratory nature of the study.|MMRM|||||0.069|-0.069|0.996
72464610|NCT01649297|144451695|NON_INFERIORITY_OR_EQUIVALENCE|"Null hypotheses for non-inferiority:~H10: Mean change from baseline in HbA1c (%) after 16 weeks of treatment with empagliflozin 5 mg twice daily ≥ mean change from baseline in HbA1c (%) after 16 weeks of treatment with empagliflozin 10 mg once daily + 0.35%~H20: Mean change from baseline in HbA1c (%) after 16 weeks of treatment with empagliflozin 12.5 mg twice daily ≥ mean change from baseline in HbA1c (%) after 16 weeks of treatment with empagliflozin 25 mg once daily + 0. 35%"|Adjusted mean difference|-0.02|STANDARD_ERROR_OF_MEAN|0.07|<|0.0001||95.0|-0.16|0.13||The two non-inferiority hypotheses H10 and H20 were tested using the Hochberg procedure in order to control the family-wise type I error at 0.025 (one-sided).|ANCOVA|ANCOVA: Treatment, geographical region, renal function (screening eGFR \[MDRD\] value)- fixed effects and baseline HbA1c- linear covariate.||The primary objective was to test the non-inferiority of empagliflozin 5 mg BID versus empagliflozin 10 mg QD, and non-inferiority of empagliflozin 12.5 mg BID versus empagliflozin 25 mg QD, assuming a non-inferiority margin of 0.35%||0.13|-0.16|<0.0001
72502429|NCT03182738|144535392|SUPERIORITY|Linear mixed models to test difference in mean score of Physical Function PROMIS T-score from baseline to 3 months between two arms.|Difference in Change|0.55||||0.83|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in Physical Function PROMIS T-score from baseline to 3 months between two arms.~Positive estimation parameter value indicates intervention arm better than control arm."|The null hypothesis is that there is no difference in change in Physical Function PROMIS T-score from baseline to 3 months between two arms.||||0.83
72502430|NCT03182738|144535392|SUPERIORITY|Linear mixed models to test difference in mean score of Sleep Disturbance PROMIS T-score from baseline to 3 months between two arms.|Difference in Change|0.84||||0.83|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in Sleep Disturbance PROMIS T-score from baseline to 3 months between two arms.~Positive estimation parameter value indicates intervention arm better than control arm."|The null hypothesis is that there is no difference in change in Sleep Disturbance PROMIS T-score from baseline to 3 months between two arms.||||0.83
72502431|NCT03182738|144535392|SUPERIORITY|Linear mixed models to test difference in mean score of Physical Function PROMIS T-score from baseline to 6 months between two arms.|Difference in Change|-0.43||||0.96|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||The parameter was estimated using a difference in change in Physical Function PROMIS T-score from baseline to 6 months between two arms.|The null hypothesis is that there is no difference in change in Physical Function PROMIS T-score from baseline to 6 months between two arms.||||0.96
72504822|NCT03114969|144540519|SUPERIORITY||Odds Ratio (OR)|1.402||||0.553|TWO_SIDED|95.0|0.459|4.283||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.|||4.283|0.459|0.553
72504823|NCT03114969|144540520|SUPERIORITY||Odds Ratio (OR)|2.523||||0.052|TWO_SIDED|95.0|0.993|6.407||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.|||6.407|0.993|0.052
72504824|NCT03114969|144540520|SUPERIORITY||Odds Ratio (OR)|2.757||||0.029|TWO_SIDED|95.0|1.107|6.862||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.|||6.862|1.107|0.029
72393950|NCT01059825|144294281|SUPERIORITY_OR_OTHER||Difference in least squares means|0.45||||0.967|TWO_SIDED|80.0|0.14|0.76||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||0.76|0.14|0.967
72393951|NCT01059825|144294282|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.76||||0.008|TWO_SIDED|80.0|-1.17|-0.36||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-0.36|-1.17|0.008
72393952|NCT01059825|144294282|SUPERIORITY_OR_OTHER||Difference in least squares means|-1.32||||0|TWO_SIDED|80.0|-1.73|-0.91||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p \<0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-0.91|-1.73|0.000
72393953|NCT01059825|144294282|SUPERIORITY_OR_OTHER||Difference in least squares means|-1.24||||0|TWO_SIDED|80.0|-1.65|-0.83||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p \<0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-0.83|-1.65|0.000
72393954|NCT01059825|144294282|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|-1.08||||0|TWO_SIDED|80.0|-1.49|-0.67||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p \<0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward..||||-0.67|-1.49|0.000
72504825|NCT03114969|144540521|SUPERIORITY||Odds Ratio (OR)|2.434||||0.024|TWO_SIDED|95.0|1.123|5.276||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta+\[Relvar Ellipta+LAMA\] as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.|||5.276|1.123|0.024
72393955|NCT01059825|144294282|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.45||||0.922|TWO_SIDED|80.0|0.04|0.86||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||0.86|0.04|0.922
72504826|NCT03114969|144540521|SUPERIORITY||Odds Ratio (OR)|2.389||||0.035|TWO_SIDED|95.0|1.061|5.376||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta+\[Relvar Ellipta+LAMA\] as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.|||5.376|1.061|0.035
72504827|NCT03114969|144540521|SUPERIORITY||Odds Ratio (OR)|2.889||||0.003|TWO_SIDED|95.0|1.434|5.819||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta+\[Relvar Ellipta+LAMA\] as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.|||5.819|1.434|0.003
72464611|NCT01649297|144451695|NON_INFERIORITY_OR_EQUIVALENCE|"Null hypotheses for non-inferiority:~H10: Mean change from baseline in HbA1c (%) after 16 weeks of treatment with empagliflozin 5 mg twice daily ≥ mean change from baseline in HbA1c (%) after 16 weeks of treatment with empagliflozin 10 mg once daily + 0.35%~H20: Mean change from baseline in HbA1c (%) after 16 weeks of treatment with empagliflozin 12.5 mg twice daily ≥ mean change from baseline in HbA1c (%) after 16 weeks of treatment with empagliflozin 25 mg once daily + 0. 35%"|Adjusted mean difference|-0.11|STANDARD_ERROR_OF_MEAN|0.07|<|0.0001||95.0|-0.26|0.03||The two non-inferiority hypotheses H10 and H20 were tested using the Hochberg procedure in order to control the family-wise type I error at 0.025 (one-sided).|ANCOVA|ANCOVA: Treatment, geographical region, renal function (screening eGFR \[MDRD\] value)- fixed effects and baseline HbA1c- linear covariate.||The primary objective was to test the non-inferiority of empagliflozin 5 mg BID versus empagliflozin 10 mg QD, and non-inferiority of empagliflozin 12.5 mg BID versus empagliflozin 25 mg QD, assuming a non-inferiority margin of 0.35%||0.03|-0.26|<0.0001
72464612|NCT01649297|144451695|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.61|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001||95.0|-0.79|-0.44|||ANCOVA|ANCOVA: Treatment, geographical region, renal function (screening eGFR \[MDRD\] value)- fixed effects and baseline HbA1c- linear covariate.||Superiority of once daily dose of empagliflozin (10 mg and 25 mg) versus placebo and superiority of twice daily dose of empagliflozin (5 mg and 12.5 mg) versus placebo in reducing HbA1c after 16 weeks of treatment was tested in an exploratory manner, to demonstrate assay sensitivity against placebo at 0.05 level (two-sided).||-0.44|-0.79|<0.0001
72464613|NCT01649297|144451695|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001||95.0|-0.68|-0.32|||ANCOVA|ANCOVA: Treatment, geographical region, renal function (screening eGFR \[MDRD\] value)- fixed effects and baseline HbA1c- linear covariate.||Superiority of once daily dose of empagliflozin (10 mg and 25 mg) versus placebo and superiority of twice daily dose of empagliflozin (5 mg and 12.5 mg) versus placebo in reducing HbA1c after 16 weeks of treatment was tested in an exploratory manner, to demonstrate assay sensitivity against placebo at 0.05 level (two-sided).||-0.32|-0.68|<0.0001
72464614|NCT01649297|144451695|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.44|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001||95.0|-0.62|-0.27|||ANCOVA|ANCOVA: Treatment, geographical region, renal function (screening eGFR \[MDRD\] value)- fixed effects and baseline HbA1c- linear covariate.||Superiority of once daily dose of empagliflozin (10 mg and 25 mg) versus placebo and superiority of twice daily dose of empagliflozin (5 mg and 12.5 mg) versus placebo in reducing HbA1c after 16 weeks of treatment was tested in an exploratory manner, to demonstrate assay sensitivity against placebo at 0.05 level (two-sided).||-0.27|-0.62|<0.0001
72464615|NCT01649297|144451695|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.42|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001||95.0|-0.6|-0.25|||ANCOVA|ANCOVA: Treatment, geographical region, renal function (screening eGFR \[MDRD\] value)- fixed effects and baseline HbA1c- linear covariate.||Superiority of once daily dose of empagliflozin (10 mg and 25 mg) versus placebo and superiority of twice daily dose of empagliflozin (5 mg and 12.5 mg) versus placebo in reducing HbA1c after 16 weeks of treatment was tested in an exploratory manner, to demonstrate assay sensitivity against placebo at 0.05 level (two-sided).||-0.25|-0.60|<0.0001
72502432|NCT03182738|144535392|SUPERIORITY|Linear mixed models to test difference in mean score of Depression PROMIS T-score from baseline to 6 months between two arms.|Difference in Change|0.07||||0.96|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in Depression PROMIS T-score from baseline to 6 months between two arms.~Positive estimation parameter value indicates intervention arm better than control arm."|The null hypothesis is that there is no difference in change in Depression PROMIS T-score from baseline to 6 months between two arms.||||0.96
72502433|NCT03182738|144535392|SUPERIORITY|Linear mixed models to test difference in mean score of Satisfaction with Social Role PROMIS T-score from baseline to 6 months between two arms.|Difference in Change|0.23||||0.96|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model|||The null hypothesis is that there is no difference in change in Satisfaction with Social Role PROMIS T-score from baseline to 6 months between two arms.|"The parameter was estimated using a difference in change in Satisfaction with Social Role PROMIS T-score from baseline to 6 months between two arms.~Positive estimation parameter value indicates intervention arm better than control arm."|||0.96
72502434|NCT03182738|144535392|SUPERIORITY|Linear mixed models to test difference in mean score of Anxiety PROMIS T-score from baseline to 6 months between two arms.|Difference in Change|0.77||||0.96|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in Anxiety PROMIS T-score from baseline to 6 months between two arms.~Positive estimation parameter value indicates intervention arm better than control arm."|The null hypothesis is that there is no difference in change in Anxiety PROMIS T-score from baseline to 6 months between two arms.||||0.96
72563996|NCT00749411|144659626|NON_INFERIORITY|GSK233705/GW642444 were declared non-inferior to placebo for heart rate if the upper limit of the 95% confidence interval for the estimated treatment difference for weighted mean heart rate was less than +10bpm.|Mean Difference (Net)|-1.0|||||TWO_SIDED|95.0|-5.5|3.5|||||Analysis performed using a Repeated Measures Model with covariates of baseline pulse rate, sex, age, smoking status, treatment and Day and Day by treatment and Day by baseline interactions.|||3.5|-5.5|
72563997|NCT04052698|144659631|NON_INFERIORITY|1-sided test where the mean ratio is less than 0.5 utilizing a negative binomial counting regression model. One-sided alpha level of 2.5%.|Mean Difference (Final Values)|0.1645|||<|0.0001|TWO_SIDED|95.0|0.10194|0.26558|||Regression, Linear|||||0.26558|0.10194|<0.0001
72621293|NCT02732145|144773191|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of Labia Majora among patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of non-specific lesions of Labia Majora in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant for the diagnosis of the vulvodynia."||||0.0000
72464616|NCT01649297|144451696|SUPERIORITY_OR_OTHER||Adjusted mean difference|-3.6|STANDARD_ERROR_OF_MEAN|2.8||||95.0|-9.0|1.8|||ANCOVA|ANCOVA: Treatment, geographical region, renal function (screening (eGFR)\[MDRD\]value)-fixed effects and baseline HbA1c,baseline FPG-linear covariates||||1.8|-9.0|
72563998|NCT04052698|144659633|NON_INFERIORITY|1-sided test where the mean ratio is less than 0.5 utilizing a negative binomial counting regression model. One-sided alpha level of 2.5%.|Mean Difference (Final Values)|0.1389|||<|0.0001|TWO_SIDED|95.0|0.07664|0.25187|||Regression, Linear|||||0.25187|0.07664|<0.0001
72464617|NCT01649297|144451696|SUPERIORITY_OR_OTHER||Adjusted mean difference|-5.0|STANDARD_ERROR_OF_MEAN|2.8||||95.0|-10.4|0.5||The two non-inferiority hypotheses H10 and H20 were tested using the Hochberg procedure in order to control the family-wise type I error at 0.025 (one-sided).|ANCOVA|ANCOVA: Treatment, geographical region, renal function (screening (eGFR)\[MDRD\]value)-fixed effects and baseline HbA1c,baseline FPG-linear covariates||||0.5|-10.4|
72464618|NCT01649297|144451696|SUPERIORITY_OR_OTHER||Adjusted mean difference|-27.5|STANDARD_ERROR_OF_MEAN|3.4|<|0.0001||95.0|-34.2|-20.9|||ANCOVA|ANCOVA:'Treatment','geographical region','renal function'(screening(eGFR)\[MDRD\]value)-fixed effects and 'baseline HbA1c',baseline FPG-linear covariate||Superiority of once daily dose of empagliflozin (10 mg and 25 mg) versus placebo and superiority of twice daily dose of empagliflozin (5 mg and 12.5 mg) versus placebo in reducing FPG after 16 weeks of treatment was tested in an exploratory manner, to demonstrate assay sensitivity against placebo at 0.05 level (two-sided)||-20.9|-34.2|<0.0001
72464619|NCT01649297|144451696|SUPERIORITY_OR_OTHER||Adjusted mean difference|-22.5|STANDARD_ERROR_OF_MEAN|3.4|<|0.0001||95.0|-29.2|-15.9|||ANCOVA|ANCOVA:'Treatment','geographical region','renal function'(screening(eGFR)\[MDRD\]value)-fixed effects and 'baseline HbA1c',baseline FPG-linear covariate||Superiority of once daily dose of empagliflozin (10 mg and 25 mg) versus placebo and superiority of twice daily dose of empagliflozin (5 mg and 12.5 mg) versus placebo in reducing FPG after 16 weeks of treatment was tested in an exploratory manner, to demonstrate assay sensitivity against placebo at 0.05 level (two-sided)||-15.9|-29.2|<0.0001
72464620|NCT01649297|144451696|SUPERIORITY_OR_OTHER||Adjusted mean difference|-21.1|STANDARD_ERROR_OF_MEAN|3.4|<|0.0001||95.0|-27.7|-14.4|||ANCOVA|ANCOVA:'Treatment','geographical region','renal function'(screening(eGFR)\[MDRD\]value)-fixed effects and 'baseline HbA1c',baseline FPG-linear covariate||Superiority of once daily dose of empagliflozin (10 mg and 25 mg) versus placebo and superiority of twice daily dose of empagliflozin (5 mg and 12.5 mg) versus placebo in reducing FPG after 16 weeks of treatment was tested in an exploratory manner, to demonstrate assay sensitivity against placebo at 0.05 level (two-sided)||-14.4|-27.7|<0.0001
72464621|NCT01649297|144451696|SUPERIORITY_OR_OTHER||Adjusted mean difference|-17.5|STANDARD_ERROR_OF_MEAN|3.4|<|0.0001||95.0|-24.1|-10.8|||ANCOVA|ANCOVA:'Treatment','geographical region','renal function'(screening(eGFR)\[MDRD\]value)-fixed effects and 'baseline HbA1c',baseline FPG-linear covariate||Superiority of once daily dose of empagliflozin (10 mg and 25 mg) versus placebo and superiority of twice daily dose of empagliflozin (5 mg and 12.5 mg) versus placebo in reducing FPG after 16 weeks of treatment was tested in an exploratory manner, to demonstrate assay sensitivity against placebo at 0.05 level (two-sided)||-10.8|-24.1|<0.0001
72563999|NCT02756637|144659645|OTHER||Hazard Ratio (HR)|1.04|||||TWO_SIDED|95.0|0.98|1.11||||||The Hazard Ration is the ratio of survival rates between patients with high NLR and low NLR.||1.11|0.98|
72464622|NCT01685047|144451697|OTHER|There were no formal pre-specified statistical hypotheses for the endpoints of the study due to the exploratory nature of this study. Datasets (Device info at Baseline versus 15 minutes prior to the event) were compared using a 2-sided t-test.|||||<|0.05||||||All events with p \<0.05 were visually inspected to confirm they were evaluable; additional criteria for exclusion from further analysis included inappropriate therapy, aberrant conduction, and occurrence of VT/VF within 24h prior to the event.|t-test, 2 sided|||There were no formal pre-specified statistical hypotheses for the endpoints of the study due to the exploratory nature of this study. Some data was excluded from the primary analysis. All device detections resulting in therapy have been reviewed for appropriateness of the therapy. VT/VF therapy delivered from the device as a result of a non-ventricular arrhythmia or as a result of oversensing by the device has not been included in the primary data analysis.||||<0.05
72464623|NCT00451555|144451712|SUPERIORITY|||||||0.6238|||||||Fisher Exact|||||||0.6238
72464624|NCT00451555|144451712|SUPERIORITY|||||||0.6282|||||||Fisher Exact|||||||0.6282
72464625|NCT00451555|144451712|SUPERIORITY|||||||0.6242|||||||Fisher Exact|||||||0.6242
72464626|NCT00451555|144451713|SUPERIORITY|||||||0.639|||||||Fisher Exact|||||||0.6390
72464627|NCT00451555|144451713|SUPERIORITY|||||||0.6721|||||||Fisher Exact|||||||0.6721
72464628|NCT00451555|144451713|SUPERIORITY|||||||0.6349|||||||Fisher Exact|||||||0.6349
72464629|NCT00451555|144451714|SUPERIORITY|||||||0.8582|||||||Log Rank|||||||0.8582
72464630|NCT00451555|144451714|SUPERIORITY|||||||0.7307|||||||Log Rank|||||||0.7307
72464631|NCT00451555|144451714|SUPERIORITY|||||||0.9798|||||||Log Rank|||||||0.9798
72464632|NCT00451555|144451715|SUPERIORITY|||||||0.5887|||||||Log Rank|||||||0.5887
72464633|NCT00451555|144451715|SUPERIORITY|||||||0.4516|||||||Log Rank|||||||0.4516
72464634|NCT00451555|144451715|SUPERIORITY|||||||0.7965|||||||Log Rank|||||||0.7965
72464635|NCT00922441|144451720|OTHER|Efficacy, Safety|||||<|0.05|||||||ANOVA|comparison between the groups||||||<0.05
72464636|NCT02973477|144451725|OTHER|Mixed effects model|Coefficient|0.28||||0.28|TWO_SIDED|95.0|-0.24|0.8||Adjusted analysis used a linear mixed effects model with unstructured covariance matrix controlled for possible period and sequence (carryover) effects for the outcome.|Mixed Models Analysis||The outcome was logged in the model. The outcome was the natural log of that variable and the coefficient and CI are for the relationship with the log of the outcome.|This is the adjusted mixed models analysis for both periods, both arms, comparing each treatment's change.||0.8|-0.24|0.28
72464637|NCT02973477|144451726|OTHER||Coefficient|-0.003||||0.97|TWO_SIDED|95.0|-0.16|0.15||Adjusted analysis used a linear mixed effects model with unstructured covariance matrix controlled for possible period and sequence (carryover) effects for the outcome.|Mixed Models Analysis||The outcome was logged in the model. The outcome was the natural log of that variable and the coefficient and CI are for the relationship with the log of the outcome.|This is the adjusted analysis to compare the difference between the values from baseline to 12 weeks between each intervention for SDNN.||0.15|-0.16|0.97
72564000|NCT02756637|144659645|OTHER||Hazard Ratio (HR)|1.01|||||TWO_SIDED|95.0|0.9|1.14||||||The Hazard Ration is the ratio of survival rates between patients with high NLR and low NLR.||1.14|0.90|
72393956|NCT01059825|144294283|SUPERIORITY_OR_OTHER||Difference in least squares means|-1.03||||0.003|TWO_SIDED|80.0|-1.51|-0.56||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-0.56|-1.51|0.003
72393957|NCT01059825|144294283|SUPERIORITY_OR_OTHER||Difference in least squares means|-1.57||||0|TWO_SIDED|80.0|-2.04|-1.09||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p \<0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-1.09|-2.04|0.000
72464638|NCT02973477|144451726|OTHER||Coefficient|-0.02||||0.79|TWO_SIDED|95.0|-0.21|0.16||Adjusted analysis used a linear mixed effects model with unstructured covariance matrix controlled for possible period and sequence (carryover) effects for the outcome.|Mixed Models Analysis||The outcome was logged in the model. The outcome was the natural log of that variable and the coefficient and CI are for the relationship with the log of the outcome.|This is the adjusted analysis to compare the difference between the values from baseline to 12 weeks between each intervention for rmsSD.||0.16|-0.21|0.79
72464639|NCT02973477|144451727|OTHER||Coefficient|0.01||||0.58|TWO_SIDED|95.0|-0.02|0.04||Adjusted analysis used a linear mixed effects model with unstructured covariance matrix controlled for possible period and sequence (carryover) effects for the outcome.|Mixed Models Analysis|||This is the adjusted analysis for both periods, both arms, comparing each treatment's change of EI ratio.||0.04|-0.02|0.58
72464640|NCT02973477|144451727|OTHER||Coefficient|0.02||||0.58|TWO_SIDED|95.0|-0.05|0.09||Adjusted analysis used a linear mixed effects model with unstructured covariance matrix controlled for possible period and sequence (carryover) effects for the outcome. Coefficient provided for Valsalva ratio.|Mixed Models Analysis||The outcome was logged in the model. The outcome was the natural log of that variable and the coefficient and CI are for the relationship with the log of the outcome.|This is the adjusted analysis for both periods, both arms, comparing each treatment's change of Valsalva ratio.||0.09|-0.05|0.58
72502435|NCT03182738|144535392|SUPERIORITY|Linear mixed models to test difference in mean score of Pain Interference PROMIS T-score from baseline to 6 months between two arms.|Difference in Change|1.05||||0.96|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in Pain Interference PROMIS T-score from baseline to 6 months between two arms.~Positive estimation parameter value indicates intervention arm better than control arm."|The null hypothesis is that there is no difference in change in Pain Interference PROMIS T-score from baseline to 6 months between two arms.||||0.96
72502436|NCT03182738|144535392|SUPERIORITY|Linear mixed models to test difference in mean score of Fatigue PROMIS T-score from baseline to 6 months between two arms.|Difference in Change|1.5||||0.96|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in Fatigue PROMIS T-score from baseline to 6 months between two arms.~Positive estimation parameter value indicates intervention arm better than control arm."|The null hypothesis is that there is no difference in change in Fatigue PROMIS T-score from baseline to 6 months between two arms.||||0.96
72502437|NCT03182738|144535392|SUPERIORITY|Linear mixed models to test difference in mean score of Sleep Disturbance PROMIS T-score from baseline to 6 months between two arms.|Difference in Change|2.04||||0.64|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in Sleep Disturbance PROMIS T-score from baseline to 6 months between two arms.~Positive estimation parameter value indicates intervention arm better than control arm."|The null hypothesis is that there is no difference in change in Sleep Disturbance PROMIS T-score from baseline to 6 months between two arms.||||0.64
72502438|NCT00728416|144535409|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.31|||<|0.001|TWO_SIDED|95.0|-0.43|-0.19|||ANCOVA|||The change from Baseline in average AM/PM PRIOR nasal congestion score over 15 days: MFNS 200 mcg daily vs placebo. The difference in LS means (MFNS - Placebo) was calculated from an ANCOVA model with treatment, site and baseline AM/PM PRIOR Nasal Congestion Score as covariates.||-0.19|-0.43|<0.001
72502439|NCT00728416|144535410|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-1.27|||<|0.001|TWO_SIDED|95.0|-1.72|-0.83|||ANCOVA|||The change from Baseline in average AM/PM PRIOR TNSS over 15 days: MFNS 200 mcg daily vs placebo. The difference in LS means (MFNS - Placebo) was calculated from an ANCOVA model with treatment, site and baseline AM/PM TNSS as covariates.||-0.83|-1.72|<0.001
72564001|NCT02449473|144659665|SUPERIORITY|The model included treatment group as fixed effect and baseline log-transformed airway submucosal eosinophils as a continuous covariate. No interaction terms were included in the model. The analysis was performed using log-transformed data. All group comparisons from analysis of covariance (ANCOVA) model were based on Type III sums of squares.|Least square (LS) geometric mean ratio|1.43||||0.3862|TWO_SIDED|95.0|0.63|3.27|||ANCOVA|||Comparison of change from baseline, expressed as a ratio, in airway submucosal eosinophils; Tralo 300 mg Q2W vs placebo. The null hypothesis was that the change in airway submucosal eosinophils at Week 12 on tralokinumab was equal to the corresponding change on placebo.||3.27|0.63|0.3862
72393958|NCT01059825|144294283|SUPERIORITY_OR_OTHER||Difference in least squares means|-1.68||||0|TWO_SIDED|80.0|-2.16|-1.21||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p \<0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-1.21|-2.16|0.000
72393959|NCT01059825|144294283|SUPERIORITY_OR_OTHER||Difference in least squares means|-1.78||||0|TWO_SIDED|80.0|-2.26|-1.3||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p \<0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-1.30|-2.26|0.000
72393960|NCT01059825|144294283|SUPERIORITY_OR_OTHER||Difference in least squares means|0.24||||0.741|TWO_SIDED|80.0|-0.24|0.71||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||0.71|-0.24|0.741
72502440|NCT01244737|144535421|OTHER||Pearson correlation co-efficient|0.8|||<|0.001|TWO_SIDED|||||The a priori threshold for statistical significance was \< 0.05.|Regression, Linear|||This is a diagnostic test of FLT uptake (SUV max) as a predictor of cellular proliferation (MIB) and is performed as an analysis of correlation using each evaluable participant enrolled in either Arm 1 (New Diagnosis) or Arm 2 (Possible recurrent tumor). The groups (Arm 1 and Arm 2) provide pathways for enrollment. Correlation between the two measures of outcome (SUV max and MIB) is evaluated.||||< 0.001
72502441|NCT01244737|144535424|OTHER|Paired T-test to assess change in FLT uptake (SUV max) with chemotherapy.||||||0.04||||||The a priori threshold for statistical significance was \< 0.05.|t-test, 2 sided|||||||0.04
72464641|NCT02973477|144451727|OTHER||Coefficient|-0.01||||0.56|TWO_SIDED|95.0|-0.05|0.03||Adjusted analysis used a linear mixed effects model with unstructured covariance matrix controlled for possible period and sequence (carryover) effects for the outcome. Coefficient provided for 30:15 ratio.|Mixed Models Analysis|||This is the adjusted analysis for both periods, both arms, comparing each treatment's change of 30:15 ratio.||0.03|-0.05|0.56
72464642|NCT02973477|144451728|OTHER||Coefficient|0.01||||0.92|TWO_SIDED|95.0|-0.23|0.25||Adjusted analysis used a linear mixed effects model with unstructured covariance matrix controlled for possible period and sequence (carryover) effects for the outcome.|Mixed Models Analysis|||This is the adjusted analysis for both periods, both arms, comparing each treatment's change of BNP.||0.25|-0.23|0.92
72502442|NCT00356915|144535429|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|This was stratified by analysis center.||P-Value from a Cochran-Mantel-Haenszel test, . The superiority analysis was restricted to the itraconazole 200-mg tablets and placebo tablets dosing groups.||||<0.001
72393961|NCT01059825|144294285|SUPERIORITY_OR_OTHER||Difference in least squares means|-2.13||||0.163|TWO_SIDED|80.0|-4.92|0.65||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||0.65|-4.92|0.163
72464643|NCT00991029|144451730|SUPERIORITY||Hazard Ratio (HR)|0.75||||0.02|TWO_SIDED|95.0|0.59|0.95|||Log Rank|||||0.95|0.59|0.02
72464644|NCT00991029|144451731|SUPERIORITY||Hazard Ratio (HR)|2.32||||0.02|TWO_SIDED|95.0|1.1|4.87|||Log Rank|||||4.87|1.10|0.02
72464645|NCT00991029|144451732|SUPERIORITY||Hazard Ratio (HR)|0.72||||0.01|TWO_SIDED|95.0|0.56|0.92|||Log Rank|||||0.92|0.56|0.01
72464646|NCT00991029|144451733|SUPERIORITY||Hazard Ratio (HR)|1.44||||0.46|TWO_SIDED|95.0|0.55|3.78|||Log Rank|||||3.78|0.55|0.46
72464647|NCT00991029|144451734|SUPERIORITY||Hazard Ratio (HR)|1.51||||0.52|TWO_SIDED|95.0|0.43|5.35|||Log Rank|||||5.35|0.43|0.52
72464648|NCT00991029|144451735|SUPERIORITY||Hazard Ratio (HR)|0.74||||0.01|TWO_SIDED|95.0|0.58|0.94|||Log Rank|||||0.94|0.58|0.01
72464649|NCT00991029|144451736|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.13|TWO_SIDED|95.0|0.67|1.05|||Log Rank|||||1.05|0.67|0.13
72464650|NCT00991029|144451737|SUPERIORITY||Hazard Ratio (HR)|1.68||||0.47|TWO_SIDED|95.0|0.4|7.03|||Log Rank|||||7.03|0.4|0.47
72464651|NCT00991029|144451738|SUPERIORITY||Hazard Ratio (HR)|1.01||||0.99|TWO_SIDED|95.0|0.14|7.14|||Log Rank|||||7.14|0.14|0.99
72464652|NCT00991029|144451739|SUPERIORITY|||||||0.16|||||||Log Rank|||||||0.16
72464653|NCT00991029|144451740|SUPERIORITY||Hazard Ratio (HR)|2.45||||0.04|TWO_SIDED|95.0|1.01|5.9|||Log Rank|||||5.9|1.01|0.04
72464654|NCT00991029|144451741|SUPERIORITY||Hazard Ratio (HR)|3.12|||<|0.001|TWO_SIDED|95.0|1.67|5.83|||Log Rank|||||5.83|1.67|<0.001
72464655|NCT00991029|144451742|SUPERIORITY||Hazard Ratio (HR)|1.51||||0.27|TWO_SIDED|95.0|0.73|3.13|||Log Rank|||||3.13|0.73|0.27
72464656|NCT01318538|144451743|SUPERIORITY_OR_OTHER|||||||0.821|TWO_SIDED|95.0|||||loglinear (negative binomial) regression|Analyzed using loglinear (negative binomial) regression models with estimation via generalized estimating equations (relative changes i.e. % change)||The models included the effects of treatment group, phase (3 levels), and the treatment group by phase interaction.The study was powered for the primary analysis concerning treatment group differences in the degree of improvement in the number of days of any substance use and in the Addiction Severity Index (ASI) composite scores. With a total of 100 women, the study was adequately powered to detect a minimum 5 day benefit in the # of days of any substance use (power = 83%).||||0.821
72464657|NCT01318538|144451744|SUPERIORITY_OR_OTHER|||||||0.519|||||||loglinear (negative binomial) regression|We used loglinear (negative binomial) regression models with estimation via generalized estimating equations (GEE).||The models included the effects of treatment group, phase (3 levels), and the treatment group by phase interaction. Note: Women in both WRG and GDC groups had significant (p\<0.0001 reductions in mean # of alcohol use days during treatment (9.9 and 12.4 day reductions for WRG and GDC respectively) and at 6 months post-treatment (8.3 and 12.2 day reductions).||||0.519
72464658|NCT01318538|144451745|SUPERIORITY_OR_OTHER|||||||0.253|TWO_SIDED|95.0|||||Linear mixed effect models|This measure was analyzed using using linear mixed effect models with estimation via restricted maximum likelihood (absolute changes in the mean).||The models included the effects of treatment group, phase (3 levels), and the treatment group by phase interaction. The study was powered for the primary analysis concerning treatment group differences in the degree of improvement in the number of days of any substance use and in the Addiction Severity Index (ASI) composite scores.With 100 women (50 in each treatment group), the study was adequately powered to detect a 0.2 benefit in the ASI drug and alcohol composite scores (power = 94%).||||0.253
72464659|NCT01318538|144451746|SUPERIORITY_OR_OTHER|||||||0.667|TWO_SIDED|95.0|||||Linear mixed effect models|This measure was analyzed using using linear mixed effect models with estimation via restricted maximum likelihood (absolute changes in the mean).||The models included the effects of treatment group, phase (3 levels), and the treatment group by phase interaction. The study was powered for the primary analysis concerning treatment group differences in the degree of improvement in the number of days of any substance use and in the Addiction Severity Index (ASI) composite scores.With 100 women (50 in each treatment group), the study was adequately powered to detect a 0.2 benefit in the ASI drug and alcohol composite scores (power = 94%).||||0.667
72464660|NCT01318538|144451748|SUPERIORITY_OR_OTHER||||||>|0.05|||||||t-test, 2 sided|||||||>0.05
72464661|NCT01318538|144451749|SUPERIORITY_OR_OTHER||||||>|0.05|||||||t-test, 2 sided|||||||>0.05
72464662|NCT01318538|144451750|SUPERIORITY_OR_OTHER|||||||0.464|||||||loglinear (negative binomial) regression|We used loglinear (negative binomial) regression models with estimation via generalized estimating equations (GEE).||The models included the effects of treatment group, phase (3 levels), and the treatment group by phase interaction. Note: Women in both WRG and GDC groups had significant (p\<0.05) reductions in mean number of drug use days during treatment (3.0 and 1.5 day reductions for WRG and GDC respectively); however at 6 months post-treatment, the reductions were significant for WRG (2.8 day reduction; p\<0.05) but not for GDC (1.5 day reduction; p\>0.01).||||0.464
72464663|NCT01318538|144451751|SUPERIORITY_OR_OTHER|||||||0.904|||||||loglinear (negative binomial) regression|We used loglinear (negative binomial) regression models with estimation via generalized estimating equations (GEE).||The models included the effects of treatment group, phase (3 levels), and the treatment group by phase interaction. Note: Women in both WRG and GDC groups had significant (p\<0.0001) reductions in mean number of heavy drinking days during treatment (8.6 and 12.1 days reduction for WRG and GDC, respectively) and at 6 months post-treatment (8.0 and 11.8 day reductions).||||0.904
72502443|NCT00356915|144535430|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority was established if the lower limit of the one-sided, 97.5% CI in the observed difference between the proportions of subjects by study drug with Complete Cure at week 52 (itraconazole 200-mg tablets minus itraconazole 100-mg capsules) was greater than -10%. No p-value was calculated for this endpoint.|Wald's CI|0.56|||||ONE_SIDED|97.5|-4.3||||Wald's CI|The statistical analysis used Wald's CI with Yates' continuity correction.||Comparison between the 2 itraconazole groups was based on lower bound of the 97.5% confidence interval for the difference. The non-inferiority analysis was restricted to the active dosing groups.|||-4.3|
72502444|NCT00356915|144535431|NON_INFERIORITY_OR_EQUIVALENCE|The assumption was that the Complete Cure rate at week 52 was 35% for the active dosing groups, a sample size of 552 ITT subjects per active group would have had a 93% power for testing the proportion of subjects with Complete Cure. These computations assumed a non inferiority margin of 10% and a one-sided significance level of 0.025. Power computations were performed using nQuery Advisor, Version 5.0.|Mean Difference (Final Values)|10.0|||<|0.001|ONE_SIDED|97.5|-1.1||||Wald's CI|The statistical analysis used Wald's CI with Yates' continuity correction.||The test for demonstrating non-inferiority was based on a margin of 10%. Thus, non-inferiority was established if the lower limit of the one-sided, 97.5% CI in the observed difference between the proportions of subjects by study drug with Complete Cure at week 52 (itraconazole 200-mg tablets minus itraconazole 100-mg capsules) was greater than -10%. The non-inferiority analysis was restricted to the active dosing groups.|||-1.1|< 0.001
72502445|NCT00356915|144535432|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|This was stratified by analysis center.||The superiority analysis was restricted to the itraconazole 200-mg tablets and placebo tablets dosing groups.||||<0.001
72502446|NCT00509106|144535439|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% Confidence Interval (CI) for the observed difference in the primary outcome measure (clinical cure rate) between the ceftaroline group and the ceftriaxone group was calculated based on the MITTE Population at the TOC visit. Noninferiority was concluded if the lower limit of the 95% CI was higher than -10% for the MITTE populations.|Risk Difference (RD)|5.9|||||TWO_SIDED|95.0|-1.0|12.7|||||Risk difference corresponds to Ceftaroline clinical cure rate minus Ceftriaxone clinical cure rate. The confidence interval was calculated using the Miettinen and Nurminen method without adjustment.|The primary objective of this study was to determine the noninferiority in the clinical cure rate for ceftaroline compared with that for ceftriaxone at TOC in the MITTE Population in adult subjects with CABP.||12.7|-1.0|
72502447|NCT00488631|144535448|SUPERIORITY_OR_OTHER|||||||0.01||||||A fixed sequence testing procedure was employed to control the overall Type I error rate at the 0.05 level (i.e., testing golimumab 100 mg vs. placebo first, then, if positive, testing 50 mg vs. placebo).|Cochran-Mantel-Haenszel|||Statistical analysis for number of participants in clinical response through Week 54 were summarized using the Cochran-Mantel-Haenszel (CMH) test stratified by clinical remission status at Week 0 and the induction dose factor.||||0.010
72502448|NCT00488631|144535448|SUPERIORITY_OR_OTHER||||||<|0.001||||||A fixed sequence testing procedure was employed to control the overall Type I error rate at the 0.05 level (i.e., testing golimumab 100 mg vs. placebo first, then, if positive, testing 50 mg vs. placebo).|Cochran-Mantel-Haenszel|||Statistical analysis for number of participants in clinical response through Week 54 were summarized using the Cochran-Mantel-Haenszel (CMH) test stratified by clinical remission status at Week 0 and the induction dose factor.||||<0.001
72564002|NCT02449473|144659666|SUPERIORITY|The repeated measures analysis included treatment group, baseline log-transformed eosinophils and visit as fixed effects. Treatment-by-visit interaction was also included. The analysis was performed using log-transformed data. A restricted maximum likelihood (REML) approach was used. An unstructured variance-covariance matrix was used to model the within-subject errors.|LS geometric mean ratio|1.21||||0.0546|TWO_SIDED|95.0|1.0|1.48|||Repeated measures analysis|||Comparison of change from baseline, expressed as a ratio, in blood eosinophil count; Tralo 300 mg Q2W vs placebo.||1.48|1.00|0.0546
72564003|NCT02449473|144659667|SUPERIORITY|The repeated measures analysis included treatment group, baseline log-transformed differential sputum eosinophils and visit as fixed effects. Treatment-by-visit interaction was also included. The analysis was performed using log-transformed data. A REML approach was used. An unstructured variance-covariance matrix was used to model the within-subject errors.|LS geometric mean ratio|0.57||||0.6334|TWO_SIDED|95.0|0.06|6.0|||Repeated measures analysis|||Comparison of change from baseline, expressed as a ratio, in differential sputum eosinophils; Tralo 300 mg Q2W vs placebo.||6.00|0.06|0.6334
72564004|NCT02449473|144659668|SUPERIORITY|The repeated measures analysis included treatment group, baseline log-transformed blood free ECP and visit as fixed effects. Treatment-by-visit interaction was also included. The analysis was performed using log-transformed data. A REML approach was used. An unstructured variance-covariance matrix was used to model the within-subject errors.|LS geometric mean ratio|1.11||||0.3769|TWO_SIDED|95.0|0.88|1.4|||Repeated measures analysis|||Comparison of change from baseline, expressed as a ratio, in blood free ECP concentration; Tralo 300 mg Q2W vs placebo.||1.40|0.88|0.3769
72621294|NCT02732145|144773191|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of the Perineum among patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of non-specific lesions of the Perineum in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant for the diagnosis of the vulvodynia."||||0.0000
72564005|NCT02449473|144659669|SUPERIORITY|The repeated measures analysis included treatment group, baseline log-transformed sputum free ECP and visit as fixed effects. Treatment-by-visit interaction was also included. The analysis was performed using log-transformed data. A REML approach was used. An unstructured variance-covariance matrix was used to model the within-subject errors.|LS geometric mean ratio|0.49||||0.1126|TWO_SIDED|95.0|0.2|1.2|||Repeated measures analysis|||Comparison of change from baseline, expressed as a ratio, in sputum free ECP concentration; Tralo 300 mg Q2W vs placebo.||1.20|0.20|0.1126
72464664|NCT01318538|144451752|SUPERIORITY_OR_OTHER|||||||0.799|||||||linear mixed effect model|This measure was analyzed using using linear mixed effect models with estimation via restricted maximum likelihood (absolute changes in the mean).||The models included the effects of treatment group, phase (3 levels), and the treatment by phase interaction. Note: Women in both the WRG and GDC groups had significant (p\<0.05) reductions in mean number of drinks per drinking day only during the in treatment phase (2.0 and 2.9 reductions for WRG and GDC, respectively).||||0.799
72464665|NCT02487251|144451763|EQUIVALENCE|Phase 1 sought to determine effect sizes. For Phase 2, sample size was set at 125 per arm which, with 20% attrition, would enable detection of small to medium effect sizes of d = 0.40SD for continuous outcomes and 38% relative risk reduction for binary outcomes with a power of 80% and α = .05.|Mean Difference (Final Values)|-0.15||||0.34|TWO_SIDED|||||p \< .05 reflects the threshold for statistical significance. The calculated p value for change in BMIz is p = .34.|Mixed Models Analysis||The reported estimation parameter is the effect size (cohen's d) for the change in BMIz (particularly in the Phase 2 sample)|We tested change in BMIz for each of the four study arms/groups.||||.34
72464666|NCT02487251|144451764|EQUIVALENCE|Sample size was set at 125 per arm which, with 20% attrition, would enable detection of small to medium effect sizes of d = 0.40SD for continuous outcomes and 38% relative risk reduction for binary outcomes with a power of 80% and α = .05. Phase 2 analyses included mixed modeling. Negative mean change values reflect a decrease in intake; positive values reflect an increase.|Mean Difference (Final Values)|-0.07||||0.62|TWO_SIDED|||||p \< .05 reflects the threshold for statistical significance. The calculated p value for change in observed fruit intake is p = .62.|Mixed Models Analysis||The reported estimation parameter is a standardized mean difference between the groups, specifically cohen's d.|We tested change in observed fruit intake for each of the two study arms/groups in Phase 2 and compared change between the usual care and intervention groups.||||.62
72464667|NCT02487251|144451765|EQUIVALENCE|Sample size was set at 125 per arm which, with 20% attrition, would enable detection of small to medium effect sizes of d = 0.40SD for continuous outcomes and 38% relative risk reduction for binary outcomes with a power of 80% and α = .05.|Mean Difference (Final Values)|0.4||||0.009|TWO_SIDED|||||p \< .05 reflects the threshold for statistical significance. The calculated p value for change in observed vegetable intake is p = .009.|Mixed Models Analysis|||We tested pre to post change in observed vegetable intake for each of the two study arms/groups in Phase 2 and compared change between the usual care and intervention groups. Positive Observed dietary quality data was not collected in Phase 1.||||.009
72464668|NCT02487251|144451766|EQUIVALENCE|Phase 1 sought to determine effect sizes. For Phase 2, sample size was set at 125 per arm which, with 20% attrition, enabled detection of small-medium effect sizes, d = 0.40SD for continuous outcomes and 38% relative risk reduction for binary outcomes, power of 80%, α = .05. Phase 1 analyses included paired t-tests \& examination of pre-post effect size change. Phase 2 analyses included mixed modeling. Negative mean change values reflect a decrease in intake; positive values reflect an increase.|Mean Difference (Final Values)|0.15||||0.21|TWO_SIDED|||||p \< .05 reflects the threshold for statistical significance. The calculated p value for change in parent reported fruit is p = .21.|Mixed Models Analysis||The reported estimation parameter is a standardized mean difference between the groups, specifically cohen's d.|We tested pre to post change in parent reported child fruit intake for each of the four study arms/groups.||||.21
72464669|NCT02487251|144451767|EQUIVALENCE|Phase 1 sought to determine effect sizes. For Phase 2, sample size was set at 125 per arm which, with 20% attrition, enabled detection of small-medium effect sizes, d = 0.40SD for continuous outcomes and 38% relative risk reduction for binary outcomes, power of 80%, α = .05. Phase 1 analyses included paired t-tests \& examination of pre-post effect size change. Phase 2 analyses included mixed modeling. Negative mean change values reflect a decrease in intake; positive values reflect an increase.|Mean Difference (Final Values)|0.07||||0.55|TWO_SIDED|||||p \< .05 reflects the threshold for statistical significance. The calculated p value for change in parent reported vegetables is p = .55.|Mixed Models Analysis||The reported estimation parameter is a standardized mean difference between the groups, specifically cohen's d.|We tested change in vegetable intake for each of the four study arms/groups.||||.55
72464670|NCT02487251|144451768|EQUIVALENCE|Phase 1 sought to determine effect sizes. For Phase 2, sample size was set at 125 per arm which, with 20% attrition, would enable detection of small to medium effect sizes of d = 0.40SD for continuous outcomes and 38% relative risk reduction for binary outcomes with a power of 80% and α = .05.|Mean Difference (Final Values)|-0.02||||0.84|TWO_SIDED|||||p \< .05 reflects the threshold for statistical significance. The calculated p value for change in mealtime frequency is p = .84.|Mixed Models Analysis|||We tested change in frequency of family mealtimes for each of the four study arms/groups.||||.84
72564006|NCT04034355|144659670|SUPERIORITY||Risk Ratio (RR)|1.521||||0.028|TWO_SIDED|95.0|1.0462|2.2113|||Cochran-Mantel-Haenszel|||||2.2113|1.0462|0.0280
72564007|NCT02190279|144659682|OTHER|||||||0.0033|||||||ANOVA|||At 1 hour post injection.||||0.0033
72564008|NCT02190279|144659682|OTHER|||||||0.012|||||||ANOVA|||At 2 hour post injection.||||0.012
72564009|NCT02190279|144659683|EQUIVALENCE|One way analysis variance.|||||<|0.05|||||||variance|||||||<0.05
72564010|NCT00546910|144659686|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.69|||<|0.001|TWO_SIDED|95.0|0.52|0.87||P-value is for Time Active overall for morning, noon and evening. Primary tests were performed hierarchically to adjust for multiplicity. Time Active was tested at rank 8.|Mixed Models Analysis|Positive values for the mean difference are in favor of the atomoxetine arm.||||0.87|0.52|<0.001
72621295|NCT02732145|144773191|SUPERIORITY|Question: Is there a difference in the incidence of erythema of Mons Pubis among patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of erythema of Mons Pubis in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant for the diagnosis of the vulvodynia."||||0.0000
72464671|NCT00570921|144451795|SUPERIORITY_OR_OTHER||Median Time to Progression|7.4|||||TWO_SIDED|95.0|1.9|12.1||||||We hypothesized that median time to progression (TTP) in our trial will increase from 3.7 months for the historical fulvestrant-only control to 7.0 months on the combination of fulvestrant and everolimus in the current trial. A sample of 40 evaluable patients was calculated to show the increase in TTP with 80% power and 5% significance level based on a two sided test of differences in survival times between historical controls and treated group.||12.1|1.9|
72464672|NCT00570921|144451796|SUPERIORITY_OR_OTHER||Response Rate Percentage|12.9|||||TWO_SIDED|95.0|3.63|29.83|||||Percentage of Patients with a complete or partial response with 95% exact binomial proportion confidence interval|||29.83|3.63|
72464673|NCT00570921|144451797|SUPERIORITY_OR_OTHER||Percentage with clinical benefit|48.39|||||TWO_SIDED|95.0|30.15|66.94|||||Percentage of patients that had a complete response, partial response, or stable disease for 24 weeks or more as defined by RECIST v1.0.|||66.94|30.15|
72464674|NCT00784277|144451803|SUPERIORITY_OR_OTHER||Difference in Least-Squares Means|55.1|STANDARD_ERROR_OF_MEAN|20.37||0.007||95.0|15.11|95.13||P-value is adjusted for multiplicity for comparison against placebo using Hochberg's test.|ANCOVA|The model includes treatment and pooled center as factors and baseline pain intensity score as covariate.|The 95% confidence interval is unadjusted for multiplicity.|||95.13|15.11|0.007
72464675|NCT00784277|144451803|SUPERIORITY_OR_OTHER||Difference in Least-Squares Means|63.4|STANDARD_ERROR_OF_MEAN|20.23||0.004||95.0|23.67|103.13||P-value is adjusted for multiplicity for comparison against placebo using Hochberg's test.|ANCOVA|The model includes treatment and pooled center as factors and baseline pain intensity score as covariate.|The 95% confidence interval is unadjusted for multiplicity.|||103.13|23.67|0.004
72464676|NCT00784277|144451804|SUPERIORITY_OR_OTHER||Difference in Least-Squares Means|3.1|STANDARD_ERROR_OF_MEAN|0.46|<|0.001||95.0|2.22|4.01||P-value is adjusted for multiplicity for comparison against Oxycodone using Hochberg's test.|ANCOVA|The model includes treatment and pooled center as factors and baseline value as covariate.|The 95% confidence interval is unadjusted for multiplicity.|||4.01|2.22|<0.001
72464677|NCT00784277|144451804|SUPERIORITY_OR_OTHER||Difference in Least-Squares Means|2.2|STANDARD_ERROR_OF_MEAN|0.45|<|0.001||95.0|1.34|3.12||P-value is adjusted for multiplicity for comparison against Oxycodone using Hochberg's test.|ANCOVA|The model includes treatment and pooled center as factors and baseline value as covariate.|The 95% confidence interval is unadjusted for multiplicity.|||3.12|1.34|<0.001
72464678|NCT00784277|144451804|SUPERIORITY_OR_OTHER||Difference in Least-Squares Means|1.6|STANDARD_ERROR_OF_MEAN|0.45|<|0.001||95.0|0.72|2.5||P-value is adjusted for multiplicity for comparison against Oxycodone using Hochberg's test.|ANCOVA|The model includes treatment and pooled center as factors and baseline value as covariate.|The 95% confidence interval is unadjusted for multiplicity.|||2.50|0.72|<0.001
72464679|NCT00999141|144451813|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||two-sided paired t-test|alpha = 5%||||||<0.0001
72464680|NCT00999141|144451816|SUPERIORITY_OR_OTHER||Difference in Proportions|0.04||||0.257||95.0|-0.039|0.125|||McNemar|alpha = 5%|Difference in Proportions = (SoC) - (FS VH S/D 4 s-apr)|||0.125|-0.039|0.257
72464681|NCT00999141|144451817|SUPERIORITY_OR_OTHER||Difference in proportions|-0.373|||<|0.001||95.0|-0.524|-0.193|||McNemar|alpha = 5%|Difference in proportions = SoC - FS VH S/D 4 s-apr|||-0.193|-0.524|<0.001
72464682|NCT00999141|144451818|SUPERIORITY_OR_OTHER||Difference in proportions|-0.387|||<|0.001||95.0|-0.538|-0.205|||McNemar||Difference in Proportions = SoC - FS VH S/D 4 s-apr|||-0.205|-0.538|<0.001
72464683|NCT00999141|144451819|SUPERIORITY_OR_OTHER||Difference in proportions|-0.356||||0.001||95.0|-0.521|-0.161|||McNemar|alpha = 5%|Difference in proportions = SoC - FS VH S/D 4 s-apr|||-0.161|-0.521|0.001
72464684|NCT00999141|144451820|SUPERIORITY_OR_OTHER||Difference in proportions|-0.189||||0.027||95.0|-0.342|-0.023|||McNemar|alpha = 5%|Difference in proportions = SoC - FS VH S/D 4 s-apr|||-0.023|-0.342|0.027
72464685|NCT00999141|144451823|SUPERIORITY_OR_OTHER||Difference in Proportions|-0.413||||||95.0|-0.577|-0.213|||||Difference in Proportions = (SoC) - (FS VH S/D 4 s-apr)|||-0.213|-0.577|
72464686|NCT00999141|144451824|SUPERIORITY_OR_OTHER||Difference in Proportions|-0.227||||||95.0|-0.413|-0.02|||||Difference in Proportions = (SoC) - (FS VH S/D 4 s-apr)|||-0.020|-0.413|
72464687|NCT00999141|144451825|SUPERIORITY_OR_OTHER||Difference in Proportions|-0.347||||||95.0|-0.518|-0.145|||||Difference in Proportions = (SoC) - (FS VH S/D 4 s-apr)|||-0.145|-0.518|
72464688|NCT00999141|144451826|SUPERIORITY_OR_OTHER||Difference in Proportions|-0.365||||||95.0|-0.528|-0.171|||||Difference in Proportions = (SoC) - (FS VH S/D 4 s-apr)|||-0.171|-0.528|
72464689|NCT03569475|144451859|SUPERIORITY||Least Square Mean Difference|-1.7|STANDARD_ERROR_OF_MEAN|1.41||0.2215|TWO_SIDED|95.0|-4.49|1.04|||Mixed Model for Repeated Measures||Estimates and p-values are based on MMRM with treatment group, pooled study center, visit, and treatment group-by-visit interaction as fixed effects, and Baseline and Baseline-by-visit as covariates using an unstructured covariance matrix.|||1.04|-4.49|0.2215
72464690|NCT03569475|144451859|SUPERIORITY||Least Square Mean Difference|-1.8|STANDARD_ERROR_OF_MEAN|1.41||0.1964|TWO_SIDED|95.0|-4.59|0.95|||Mixed Model for Repeated Measures||Estimates and p-values are based on MMRM with treatment group, pooled study center, visit, and treatment group-by-visit interaction as fixed effects, and Baseline and Baseline-by-visit as covariates using an unstructured covariance matrix.|||0.95|-4.59|0.1964
72464691|NCT03569475|144451860|SUPERIORITY||Least Square Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.13||0.6789|TWO_SIDED|95.0|-0.32|0.21|||Mixed Model for Repeated Measures||Estimates and p-values are based on MMRM with treatment group, pooled study center, visit, and treatment group-by-visit interaction as fixed effects, and Baseline and Baseline-by-visit as covariates using an unstructured covariance matrix.|||0.21|-0.32|0.6789
72464692|NCT03569475|144451860|SUPERIORITY||Least Square Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.13||0.1126|TWO_SIDED|95.0|-0.48|0.05|||Mixed Model for Repeated Measures|||||0.05|-0.48|0.1126
72464693|NCT03638258|144451866|SUPERIORITY|Missing data imputed using linear interpolation and last observation carried forward (LOCF) where linear interpolation was not computationally possible.|||||<|0.001|||||||Regression, Logistic|Logistic regression with a factor of treatment group and a covariate of baseline IGA score.||||||<0.001
72502449|NCT00488631|144535449|SUPERIORITY_OR_OTHER|||||||0.122||||||Fixed sequence testing; 100 mg group was tested if it was positive for preceding endpoint, regardless whether 50 mg group was positive;50 mg group was tested if 100 mg group positive for same endpoint and 50 mg group positive for preceding endpoint.|Cochran-Mantel-Haenszel|||Statistical analysis for number of participants with clinical remission at both Week 30 and Week 54 were summarized using the CMH test stratified by clinical remission status at Week 0 and the induction dose factor.||||0.122
72502450|NCT00488631|144535449|SUPERIORITY_OR_OTHER|||||||0.004||||||Fixed sequence testing; 100 mg group was tested if it was positive for preceding endpoint, regardless whether 50 mg group was positive;50 mg group was tested if 100 mg group positive for same endpoint and 50 mg group positive for preceding endpoint.|Cochran-Mantel-Haenszel|||Statistical analysis for number of participants with clinical remission at both Week 30 and Week 54 were summarized using the CMH test stratified by clinical remission status at Week 0 and the induction dose factor.||||0.004
72502451|NCT00488631|144535450|SUPERIORITY_OR_OTHER|||||||0.011||||||Fixed sequence testing; 100 mg group was tested if it was positive for preceding endpoint, regardless whether 50 mg group was positive;50 mg group was tested if 100 mg group positive for same endpoint and 50 mg group positive for preceding endpoint.|Cochran-Mantel-Haenszel|||Statistical analysis for number of participants with mucosal healing at both Week 30 and Week 54 were summarized using CMH test stratified by clinical remission status at Week 0 and the induction dose factor.||||0.011
72502452|NCT00488631|144535450|SUPERIORITY_OR_OTHER|||||||0.002||||||Fixed sequence testing; 100 mg group was tested if it was positive for preceding endpoint, regardless whether 50 mg group was positive;50 mg group was tested if 100 mg group positive for same endpoint and 50 mg group positive for preceding endpoint.|Cochran-Mantel-Haenszel|||Statistical analysis for number of participants with mucosal healing at both Week 30 and Week 54 were summarized using CMH test stratified by clinical remission status at Week 0 and the induction dose factor.||||0.002
72502453|NCT00488631|144535451|SUPERIORITY_OR_OTHER|||||||0.365||||||Fixed sequence testing; 100 mg group was tested if it was positive for preceding endpoint, regardless whether 50 mg group was positive;50 mg group was tested if 100 mg group positive for same endpoint and 50 mg group positive for preceding endpoint.|Cochran-Mantel-Haenszel|||Statistical analysis for number of participants with clinical remission at both Week 30 and 54 among participants with clinical remission at Week 0 of maintenance study were summarized using CMH test stratified by the induction dose factor.||||0.365
72502454|NCT00488631|144535451|SUPERIORITY_OR_OTHER|||||||0.098||||||Fixed sequence testing; 100 mg group was tested if it was positive for preceding endpoint, regardless whether 50 mg group was positive;50 mg group was tested if 100 mg group positive for same endpoint and 50 mg group positive for preceding endpoint.|Cochran-Mantel-Haenszel|||Statistical analysis for number of participants with clinical remission at both Week 30 and 54 among participants with clinical remission at Week 0 of maintenance study were summarized using CMH test stratified by the induction dose factor.||||0.098
72502455|NCT00488631|144535452|SUPERIORITY_OR_OTHER|||||||0.279||||||Fixed sequence testing; 100 mg group was tested if it was positive for preceding endpoint, regardless whether 50 mg group was positive;50 mg group was tested if 100 mg group positive for same endpoint and 50 mg group positive for preceding endpoint.|Cochran-Mantel-Haenszel|||Statistical analysis for number of participants with clinical remission at Week 54 and not receiving concomitant corticosteroids among participants on corticosteroids at Week 0 of maintenance study were summarized using the CMH test stratified by clinical remission status at Week 0 and the induction dose factor.||||0.279
72502456|NCT00488631|144535452|SUPERIORITY_OR_OTHER|||||||0.423||||||Fixed sequence testing; 100 mg group was tested if it was positive for preceding endpoint, regardless whether 50 mg group was positive;50 mg group was tested if 100 mg group positive for same endpoint and 50 mg group positive for preceding endpoint.|Cochran-Mantel-Haenszel|||Statistical analysis for number of participants with clinical remission at Week 54 and not receiving concomitant corticosteroids among participants on corticosteroids at Week 0 of maintenance study were summarized using the CMH test stratified by clinical remission status at Week 0 and the induction dose factor.||||0.423
72502457|NCT01873950|144535453|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|||||For each ECG biomarker and treatment, the null hypothesis is that there is no difference in the biomarker change from baseline between the treatment and placebo.|Mixed Models Analysis|For each ECG biomarker and treatment, the placebo-corrected change from baseline was computed using linear mixed effect model.||||||<0.05
72502458|NCT01873950|144535454|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|||||For each ECG biomarker and treatment, the null hypothesis is that there is no difference in the biomarker change from baseline between the treatment and placebo.|Mixed Models Analysis|For each ECG biomarker and treatment, the placebo-corrected change from baseline was computed using linear mixed effect model.||||||<0.05
72564011|NCT00546910|144659686|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.27|||<|0.001|TWO_SIDED|95.0|0.98|1.57||P-value is for Distance overall for morning, noon and evening. Primary tests were performed hierarchically to adjust for multiplicity. Distance was tested at rank 5.|Mixed Models Analysis|Positive values for the mean difference are in favor of the atomoxetine arm.||||1.57|0.98|<0.001
72564012|NCT00546910|144659686|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.08|||<|0.001|TWO_SIDED|95.0|0.81|1.35||P-value is for Area overall for morning, noon and evening. Primary tests were performed hierarchically to adjust for multiplicity. Area was tested at rank 6.|Mixed Models Analysis|Positive values for the mean difference are in favor of the atomoxetine arm.||||1.35|0.81|<0.001
72564013|NCT00546910|144659686|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.0|||<|0.001|TWO_SIDED|95.0|0.78|1.22||P-value is for Microevents overall for morning, noon and evening. Primary tests were performed hierarchically to adjust for multiplicity. Microevents was tested at rank 3.|Mixed Models Analysis|Positive values for the mean difference are in favor of the atomoxetine arm.||||1.22|0.78|<0.001
72564014|NCT00546910|144659686|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.38|||<|0.001|TWO_SIDED|95.0|0.18|0.58||P-value is for Motion Simplicity overall for morning, noon and evening. Primary tests were performed hierarchically to adjust for multiplicity. Motion Simplicity was tested at rank 9.|Mixed Models Analysis|Positive values for the mean difference are in favor of the atomoxetine arm.||||0.58|0.18|<0.001
72564015|NCT00546910|144659687|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.6|||<|0.001|TWO_SIDED|95.0|8.2|14.99||P-value for ADHD-RS Total Score|Mixed Models Analysis|Positive values for the mean difference are in favor of the atomoxetine arm.||Comparison of atomoxetine vs. placebo at Visit 7 (Week 8)||14.99|8.20|<0.001
72564016|NCT00546910|144659688|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.11|||<|0.001|TWO_SIDED|95.0|0.76|1.46||P-value for CGI-S ADHD score|Mixed Models Analysis|Positive values for the mean difference are in favor of the atomoxetine arm.||Comparison of atomoxetine vs. placebo at Visit 7 (Week 8)||1.46|0.76|<0.001
72564017|NCT00546910|144659689|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.74|||<|0.001|TWO_SIDED|95.0|3.55|7.92||P-value for Total Score|Mixed Models Analysis|Positive values for the mean difference are in favor of the atomoxetine arm.||||7.92|3.55|<0.001
72564018|NCT00546910|144659689|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.96||||0.001|TWO_SIDED|95.0|2.49|5.44||P-value for Evening subscore|Mixed Models Analysis|Positive values for the mean difference are in favor of the atomoxetine arm.||||5.44|2.49|0.001
72621296|NCT02732145|144773191|SUPERIORITY|Question: Is there a difference in the incidence of erythema of Labia Majora among patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of erythema of Labia Majora in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant for the diagnosis of the vulvodynia."||||0.0000
72621297|NCT02732145|144773191|SUPERIORITY|Question: Is there a difference in the incidence of erythema of the Perineum among patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of erythema of the Perineum in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant for the diagnosis of the vulvodynia."||||0.0000
72621298|NCT02732145|144773191|SUPERIORITY|Question: Is there a difference in the incidence of excoriations of Mons Pubis among patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of excoriations of Mons Pubis in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant for the diagnosis of the vulvodynia."||||0.0000
72621299|NCT02732145|144773191|SUPERIORITY|Question: Is there a difference in the incidence of excoriations of Labia Majora among patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of excoriations of Labia Majora in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant for the diagnosis of the vulvodynia."||||0.0000
72621300|NCT02732145|144773191|SUPERIORITY|Question: Is there a difference in the incidence of excoriations of the Perineum among patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of excoriations of the Perineum in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant for the diagnosis of the vulvodynia."||||0.0000
72621301|NCT02732145|144773191|SUPERIORITY|Question: Is there a difference in the incidence of rhagades of Mons Pubis among patients from different groups?||||||0.0016|||||||Chi-squared|||"Parameter: The incidence of rhagades of Mons Pubis in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant for the diagnosis of the vulvodynia."||||0.0016
72621302|NCT02732145|144773191|SUPERIORITY|Question: Is there a difference in the incidence of rhagades of Labia Majora among patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of rhagades of Labia Majora in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant for the diagnosis of the vulvodynia."||||0.0000
72464694|NCT03638258|144451866|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpolation was not computationally possible.||||||0.004|||||||Regression, Logistic|Logistic regression with a factor of treatment group and a covariate of baseline IGA score.||||||0.004
72464695|NCT03638258|144451867|SUPERIORITY|Missing data imputed using linear interpolation and last observation carried forward where linear interpolation was not computationally possible.||||||0.015|||||||Regression, Logistic|Logistic regression with a factor of treatment group and a covariate of baseline IGA score.||Difference from vehicle cream at Week 4||||0.015
72464696|NCT03638258|144451867|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.||||||0.174|||||||Regression, Logistic|Logistic regression with a factor of treatment group and a covariate of baseline IGA score.||Difference from placebo at Week 4||||0.174
72564019|NCT00546910|144659689|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.18|||<|0.002|TWO_SIDED|95.0|0.42|1.93||P-value for Morning subscore|Mixed Models Analysis|Positive values for the mean difference are in favor of the atomoxetine arm.||||1.93|0.42|<0.002
72564020|NCT00546910|144659689|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.62|||<|0.001|TWO_SIDED|95.0|0.31|0.93||P-value for Item 11 (difficulty falling asleep).|Mixed Models Analysis|Positive values for the mean difference are in favor of the atomoxetine arm.||||0.93|0.31|<0.001
72564021|NCT00546910|144659690|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.01|||<|0.001|TWO_SIDED|95.0|0.66|1.35||P-value is for Reaction Time Variation overall for morning, noon and evening. Primary tests were performed hierarchically to adjust for multiplicity. Reaction time variation was tested at rank 1.|Mixed Models Analysis|Positive values for the mean difference are in favor of the atomoxetine arm.||||1.35|0.66|<0.001
72621303|NCT02732145|144773191|SUPERIORITY|Question: Is there a difference in the incidence of rhagades of the Perineum among patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of rhagades of the Perineum in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant for the diagnosis of the vulvodynia."||||0.0000
72393962|NCT01059825|144294285|SUPERIORITY_OR_OTHER||Difference in least squares means|-3.48||||0.056|TWO_SIDED|80.0|-6.28|-0.68||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-0.68|-6.28|0.056
72393963|NCT01059825|144294285|SUPERIORITY_OR_OTHER||Difference in least squares means|-2.88||||0.096|TWO_SIDED|80.0|-5.7|-0.05||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-0.05|-5.70|0.096
72393964|NCT01059825|144294285|SUPERIORITY_OR_OTHER||Difference in least squares means|-3.37||||0.064|TWO_SIDED|80.0|-6.21|-0.53||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-0.53|-6.21|0.064
72393965|NCT01059825|144294285|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.54||||0.403|TWO_SIDED|80.0|-3.33|2.26||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||2.26|-3.33|0.403
72393966|NCT01059825|144294286|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.37||||0.425|TWO_SIDED|80.0|-2.91|2.17||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||2.17|-2.91|0.425
72464697|NCT03638258|144451867|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.|||||<|0.001|||||||Regression, Logistic|Logistic regression with a factor of treatment group and a covariate of baseline IGA score.||Difference from vehicle cream at Week 8||||<0.001
72464698|NCT03638258|144451867|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.||||||0.001|||||||Regression, Logistic|Logistic regression with a factor of treatment group and a covariate of baseline IGA score.||Difference from vehicle cream at Week 8||||0.001
72464699|NCT03638258|144451867|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.|||||<|0.001|||||||Regression, Logistic|Logistic regression with a factor of treatment group and a covariate of baseline IGA score.||Difference from vehicle cream at Week 12||||<0.001
72564022|NCT00546910|144659690|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.7|||<|0.001|TWO_SIDED|95.0|0.46|0.93||P-value is for Omission Error overall for morning, noon and evening. Primary tests were performed hierarchically to adjust for multiplicity. Omission error was tested at rank 7.|Mixed Models Analysis|Positive values for the mean difference are in favor of the atomoxetine arm.||||0.93|0.46|<0.001
72393967|NCT01059825|144294286|SUPERIORITY_OR_OTHER||Difference in least squares means|-2.81||||0.082|TWO_SIDED|80.0|-5.38|-0.23||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-0.23|-5.38|0.082
72393968|NCT01059825|144294286|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.35||||0.43|TWO_SIDED|80.0|-2.92|2.21||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||2.21|-2.92|0.430
72393969|NCT01059825|144294286|SUPERIORITY_OR_OTHER||Difference in least squares means|-3.47||||0.043|TWO_SIDED|80.0|-6.05|-0.89||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-0.89|-6.05|0.043
72393970|NCT01059825|144294286|SUPERIORITY_OR_OTHER||Difference in least squares means|1.01||||0.694|TWO_SIDED|80.0|-1.55|3.58||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||3.58|-1.55|0.694
72393971|NCT01059825|144294287|SUPERIORITY_OR_OTHER||Difference in least squares means|-1.38||||0.234|TWO_SIDED|80.0|-3.81|1.05||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||1.05|-3.81|0.234
72464700|NCT03638258|144451867|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.||||||0.008|||||||Regression, Logistic|Logistic regression with a factor of treatment group and a covariate of baseline IGA score.||Difference from vehicle cream at Week 12||||0.008
72464701|NCT03638258|144451868|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.|||||<|0.001|||||||ANCOVA|ANCOVA with a factor of treatment group and a covariate of baseline mPASI score.||Difference from vehicle cream at Week 4||||<0.001
72464702|NCT03638258|144451868|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.|||||<|0.001|||||||ANCOVA|ANCOVA with a factor of treatment group and a covariate of baseline mPASI score.||Difference from vehicle cream at Week 4||||<0.001
72564023|NCT00546910|144659690|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.41|||<|0.001|TWO_SIDED|95.0|0.17|0.65||P-value is for Mean Reaction Time overall for morning, noon and evening. Primary tests were performed hierarchically to adjust for multiplicity. Mean reaction time was tested at rank 2.|Mixed Models Analysis|Positive values for the mean difference are in favor of the atomoxetine arm.||||0.65|0.17|<0.001
72393972|NCT01059825|144294287|SUPERIORITY_OR_OTHER||Difference in least squares means|-2.59||||0.087|TWO_SIDED|80.0|-5.03|-0.14||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-0.14|-5.03|0.087
72393973|NCT01059825|144294287|SUPERIORITY_OR_OTHER||Difference in least squares means|-2.86||||0.068|TWO_SIDED|80.0|-5.33|-0.4||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-0.40|-5.33|0.068
72393974|NCT01059825|144294287|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.77||||0.346|TWO_SIDED|80.0|-3.25|1.71||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||1.71|-3.25|0.346
72393975|NCT01059825|144294287|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.76||||0.346|TWO_SIDED|80.0|-3.21|1.7||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||1.70|-3.21|0.346
72393976|NCT01059825|144294288|SUPERIORITY_OR_OTHER||Difference in least squares means|-1.1||||0.306|TWO_SIDED|80.0|-3.87|1.67||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||1.67|-3.87|0.306
72393977|NCT01059825|144294288|SUPERIORITY_OR_OTHER||Difference in least squares means|-2.41||||0.133|TWO_SIDED|80.0|-5.19|0.37||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||0.37|-5.19|0.133
72464703|NCT03638258|144451868|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.|||||<|0.001|||||||ANCOVA|ANCOVA with a factor of treatment group and a covariate of baseline mPASI score.||Difference from vehicle cream at Week 6||||<0.001
72464704|NCT03638258|144451868|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.|||||<|0.001|||||||ANCOVA|ANCOVA with a factor of treatment group and a covariate of baseline mPASI score.||Difference from vehicle cream at Week 6||||<0.001
72464705|NCT03638258|144451868|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.x|||||<|0.001|||||||ANCOVA|ANCOVA with a factor of treatment group and a covariate of baseline mPASI score.||Difference from vehicle cream at Week 8||||<0.001
72464706|NCT03638258|144451868|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.|||||<|0.001|||||||ANOVA|ANCOVA with a factor of treatment group and a covariate of baseline mPASI score.||Difference from vehicle cream at Week 8||||<0.001
72464707|NCT03638258|144451868|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.|||||<|0.001|||||||Regression, Logistic|ANCOVA with a factor of treatment group and a covariate of baseline mPASI score.||Difference from vehicle cream at Week 12||||<0.001
72464708|NCT03638258|144451868|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.|||||<|0.001|||||||ANCOVA|ANCOVA with a factor of treatment group and a covariate of baseline mPASI score.||Difference from vehicle cream at Week 12||||<0.001
72464709|NCT03638258|144451869|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.|||||<|0.001|||||||Regression, Logistic|ANCOVA with a factor of treatment group and a covariate of baseline BSA score.||Difference from vehicle cream on Week 4||||<0.001
72393978|NCT01059825|144294288|SUPERIORITY_OR_OTHER||Difference in least squares means|-2.61||||0.117|TWO_SIDED|80.0|-5.42|0.2||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||0.20|-5.42|0.117
72464710|NCT03638258|144451869|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.|||||<|0.001|||||||Regression, Logistic|ANCOVA with a factor of treatment group and a covariate of baseline BSA score.||Difference from vehicle cream at Week 4||||<0.001
72464711|NCT03638258|144451869|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.|||||<|0.001|||||||ANCOVA|ANCOVA with a factor of treatment group and a covariate of baseline BSA score.||Difference from vehicle cream at Week 6||||<0.001
72464712|NCT03638258|144451869|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.|||||<|0.001|||||||ANCOVA|ANCOVA with a factor of treatment group and a covariate of baseline BSA score.||Difference from vehicle cream at Week 6||||<0.001
72464713|NCT03638258|144451869|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.|||||<|0.001|||||||ANCOVA|ANCOVA with a factor of treatment group and a covariate of baseline BSA score.||Difference from vehicle at Week 8||||<0.001
72464714|NCT03638258|144451869|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.|||||<|0.001|||||||ANCOVA|ANCOVA with a factor of treatment group and a covariate of baseline BSA score.||Difference from vehicle cream at Week 8||||<0.001
72464715|NCT03638258|144451869|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.|||||<|0.001|||||||ANCOVA|ANCOVA with a factor of treatment group and a covariate of baseline BSA score.||Difference from vehicle at Week 12||||<0.001
72464716|NCT03638258|144451869|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.|||||<|0.001|||||||ANCOVA|ANCOVA with a factor of treatment group and a covariate of baseline BSA score.||Difference from vehicle cream at Week 12||||<0.001
72464717|NCT03638258|144451870|SUPERIORITY|Missing data imputed using linear interpolation and last observation carried forward where linear interpolation was not computationally possible.||||||0.116|||||||Regression, Logistic|Logistic regression with a factor of treatment group and a covariate of baseline IGA score.||Difference from vehicle cream at Week 4||||0.116
72464718|NCT03638258|144451870|SUPERIORITY|Missing data imputed using linear interpolation and last observation carried forward where linear interpolation was not computationally possible.||||||0.423|||||||Regression, Logistic|Logistic regression with a factor of treatment group and a covariate of baseline IGA score.||Difference from vehicle cream at Week 4||||0.423
72464719|NCT03638258|144451870|SUPERIORITY|Missing data imputed using linear interpolation and last observation carried forward where linear interpolation was not computationally possible.||||||0.002|||||||Regression, Logistic|Logistic regression with a factor of treatment group and a covariate of baseline IGA score.||Difference from vehicle cream at Week 6||||0.002
72464720|NCT03638258|144451870|SUPERIORITY|Missing data imputed using linear interpolation and last observation carried forward where linear interpolation was not computationally possible.||||||0.038|||||||Regression, Logistic|Logistic regression with a factor of treatment group and a covariate of baseline IGA score.||Difference from vehicle cream at Week 6||||0.038
72564024|NCT00546910|144659690|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.5|||<|0.001|TWO_SIDED|95.0|0.26|0.73||P-value is for Normalized Variation of Reaction Time overall for morning, noon and evening. Primary tests were performed hierarchically to adjust for multiplicity. Normalized Variation of Reaction Time was tested at rank 10.|Mixed Models Analysis|Positive values for the mean difference are in favor of the atomoxetine arm.||||0.73|0.26|<0.001
72464721|NCT03638258|144451870|SUPERIORITY|Missing data imputed using linear interpolation and last observation carried forward where linear interpolation was not computationally possible.|||||<|0.001|||||||Regression, Logistic|Logistic regression with a factor of treatment group and a covariate of baseline IGA score.||Difference from vehicle cream at Week 8||||<0.001
72464722|NCT03638258|144451870|SUPERIORITY|Missing data imputed using linear interpolation and last observation carried forward where linear interpolation was not computationally possible.||||||0.005|||||||Regression, Logistic|Logistic regression with a factor of treatment group and a covariate of baseline IGA score.||Difference from vehicle cream at Week 8||||0.005
72464723|NCT03638258|144451870|SUPERIORITY|Missing data imputed using linear interpolation and last observation carried forward where linear interpolation was not computationally possible.||||||0.002|||||||Regression, Logistic|Logistic regression with a factor of treatment group and a covariate of baseline IGA score.||Difference from vehicle cream at Week 12||||0.002
72464724|NCT03638258|144451870|SUPERIORITY|Missing data imputed using linear interpolation and last observation carried forward where linear interpolation was not computationally possible.||||||0.013|||||||Regression, Logistic|Logistic regression with a factor of treatment group and a covariate of baseline IGA score.||Difference from vehicle cream at Week 12||||0.013
72464725|NCT03638258|144451871|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.||||||0.086|||||||Regression, Logistic|Logistic regression with a factor of treatment group and a covariate of baseline I-IGA score.||Difference form vehicle cream at Week 4||||0.086
72464726|NCT03638258|144451871|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.||||||0.123|||||||Regression, Logistic|Logistic regression with a factor of treatment group and a covariate of baseline I-IGA score.||Difference from vehicle cream at Week 4||||0.123
72464727|NCT03638258|144451871|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.||||||0.017|||||||Regression, Logistic|Logistic regression with a factor of treatment group and a covariate of baseline I-IGA score.||Difference from vehicle cream at Week 6||||0.017
72464728|NCT03638258|144451871|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.||||||0.415|||||||Regression, Logistic|Logistic regression with a factor of treatment group and a covariate of baseline I-IGA score.||Difference from vehicle cream at Week 6||||0.415
72502459|NCT01873950|144535455|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|||||For each ECG biomarker and treatment, the null hypothesis is that there is no difference in the biomarker change from baseline between the treatment and placebo.|Mixed Models Analysis|For each ECG biomarker and treatment, the placebo-corrected change from baseline was computed using linear mixed effect model.||||||<0.05
72502460|NCT02039947|144535475|SUPERIORITY||Response rate|59.0|||<|0.0001|TWO_SIDED|95.0|47.3|70.4|||percent||Percent|||70.4|47.3|<.0001
72502461|NCT01772134|144535483|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.147|||<|0.001|TWO_SIDED|95.0|0.107|0.187|||Mixed Models Analysis|||||0.187|0.107|<0.001
72564025|NCT00546910|144659691|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.5|||<|0.001|TWO_SIDED|95.0|0.31|0.68||P-value is for Commission Error overall for morning, noon and evening. Primary tests were performed hierarchically to adjust for multiplicity. Commission Error was tested at rank 4.|Mixed Models Analysis|Positive values for the mean difference are in favor of the atomoxetine arm.||||0.68|0.31|<0.001
72564026|NCT00546910|144659691|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.17||||0.022|TWO_SIDED|95.0|0.02|0.31||P-value is for Anticipatory Response overall for morning, noon and evening. Anticipatory Response was not tested in the primary analysis but is a secondary endpoint.|Mixed Models Analysis|Positive values for the mean difference are in favor of the atomoxetine arm.||||0.31|0.02|0.022
72564027|NCT00546910|144659692|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.94|||<|0.001|TWO_SIDED|95.0|0.69|1.18||P-value is for Error Rate overall for morning, noon and evening. Error Rate was not tested in the primary analysis but is a secondary endpoint.|Mixed Models Analysis|Positive values for the mean difference are in favor of the atomoxetine arm.||||1.18|0.69|<0.001
72502462|NCT01772134|144535483|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.138|||<|0.001|TWO_SIDED|95.0|0.097|0.178|||Mixed Models Analysis|||||0.178|0.097|<0.001
72464729|NCT03638258|144451871|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.||||||0.007|||||||Regression, Logistic|Logistic regression with a factor of treatment group and a covariate of baseline I-IGA score.||Difference from vehicle cream at Week 8||||0.007
72464730|NCT03638258|144451871|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.||||||0.175|||||||Regression, Linear|Logistic regression with a factor of treatment group and a covariate of baseline I-IGA score.||Difference from vehicle cream at Week 8||||0.175
72464731|NCT03638258|144451871|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.||||||0.001|||||||Regression, Logistic|Logistic regression with a factor of treatment group and a covariate of baseline I-IGA score.||Difference from vehicle at Week 12||||0.001
72464732|NCT03638258|144451871|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.||||||0.619|||||||Regression, Logistic|Logistic regression with a factor of treatment group and a covariate of baseline I-IGA score.||Difference from vehicle cream at Week 12||||0.619
72464733|NCT03638258|144451872|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.|||||<|0.001|||||||ANCOVA|ANCOVA with a factor of treatment group and a covariate of baseline WI-NRS score.||Difference from vehicle cream at Week 4||||<0.001
72464734|NCT03638258|144451872|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.||||||0.002|||||||ANCOVA|ANCOVA with a factor of treatment group and a covariate of baseline WI-NRS score.||Difference from vehicle cream at Week 4||||0.002
72502463|NCT01740362|144535487|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|137.26|||||TWO_SIDED|90.0|96.77|194.69||||||1 way Analysis of Variance (ANOVA) on natural log-transformed AUC(0-∞) analyzed using linear model with degrees of renal impairment(creatinine clearance\[CLcr, discrete\]) evaluated using blood samples collected at screening as fixed effect. Statistical Analysis System (SAS) mixed procedure (PROC MIXED) was used. Anti-log of adjusted mean difference (CP-690,550\[mild renal insufficiency\] - CP-690,550\[normal renal function\]), 90% confidence interval (CI) were taken to estimate mean ratio and 90% CI.||194.69|96.77|
72502464|NCT01740362|144535487|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|142.59|||||TWO_SIDED|90.0|100.53|202.24||||||One way ANOVA on natural log-transformed AUC (0 - ∞) were analyzed using linear model containing degrees of renal impairment (CLcr, discrete) calculated using blood samples collected at screening as fixed effects. SAS procedure PROC MIXED was used for analysis. Anti-log of the adjusted mean difference (CP-690,550 \[moderate renal insufficiency\] - CP-690,550 \[normal renal function\]) and its corresponding 90% CI were taken to estimate the mean ratio and corresponding 90% CI.||202.24|100.53|
72564028|NCT00546910|144659692|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.12||||0.178|TWO_SIDED|95.0|0.05|0.28||P-value is for Multi Response overall for morning, noon and evening. Multi Response was not tested in the primary analysis but is a secondary endpoint.|Mixed Models Analysis|Positive values for the mean difference are in favor of the atomoxetine arm.||||0.28|0.05|0.178
72564029|NCT01115855|144659693|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.85|||||TWO_SIDED|95.0|0.53|1.36||||||Cox Proportional Hazard Model with baseline New York Heart Association (NYHA) cohort (II, III/IV) and baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) covariates.||1.36|0.53|
72464735|NCT03638258|144451872|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.|||||<|0.001|||||||ANCOVA|ANCOVA with a factor of treatment group and a covariate of baseline WI-NRS score.||Difference from vehicle cream at Week 6||||<0.001
72464736|NCT03638258|144451872|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.|||||<|0.001|||||||ANCOVA|ANCOVA with a factor of treatment group and a covariate of baseline WI-NRS score.||Difference from vehicle cream at Week 6||||<0.001
72464737|NCT03638258|144451872|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.|||||<|0.001|||||||ANCOVA|ANCOVA with a factor of treatment group and a covariate of baseline WI-NRS score.||Difference from vehicle cream at Week 8||||<0.001
72464738|NCT03638258|144451872|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.|||||<|0.001|||||||ANCOVA|ANCOVA with a factor of treatment group and a covariate of baseline WI-NRS score.||Difference from vehicle cream at Week 8||||<0.001
72464739|NCT03638258|144451872|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.|||||<|0.001|||||||ANCOVA|ANCOVA with a factor of treatment group and a covariate of baseline WI-NRS score.||Difference from vehicle cream at Week 12||||<0.001
72464740|NCT03638258|144451872|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.|||||<|0.001|||||||ANCOVA|ANCOVA with a factor of treatment group and a covariate of baseline WI-NRS score.||Difference from vehicle cream at Week 12||||<0.001
72464741|NCT03638258|144451873|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.||||||0.002|||||||Regression, Logistic|Logistic regression with a factor of treatment group and a covariate of baseline WI-NRS score.||Difference from vehicle cream at Week 4||||0.002
72464742|NCT03638258|144451873|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.||||||0.203|||||||ANCOVA|ANCOVA with a factor of treatment group and a covariate of baseline WI-NRS score.||Difference from vehicle cream at Week 4||||0.203
72464743|NCT03638258|144451873|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.||||||0.034|||||||Regression, Logistic|Logistic regression with a factor of treatment group and a covariate of baseline WI-NRS score.||Difference from vehicle cream at Week 6||||0.034
72464744|NCT03638258|144451873|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.||||||0.012|||||||Regression, Logistic|Logistic regression with a factor of treatment group and a covariate of baseline WI-NRS score.||Difference from vehicle cream at Week 6||||0.012
72564030|NCT01115855|144659694|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.86|||||TWO_SIDED|95.0|0.56|1.31||||||Cox Proportional Hazard Model with baseline NYHA cohort (II, III/IV) and baseline eGFR (30--\<50 ml/min/1.73 m\^2, \>-=50 ml/min/1.73 m\^2) covariates.||1.31|0.56|
72464745|NCT03638258|144451873|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.||||||0.01|||||||Regression, Logistic|Logistic regression with a factor of treatment group and a covariate of baseline WI-NRS score.||Difference from vehicle cream at Week 8||||0.010
72464746|NCT03638258|144451873|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.||||||0.075|||||||Regression, Logistic|Logistic regression with a factor of treatment group and a covariate of baseline WI-NRS score.||Difference from vehicle cream at Week 8||||0.075
72464747|NCT03638258|144451873|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.|||||<|0.001|||||||Regression, Logistic|Logistic regression with a factor of treatment group and a covariate of baseline WI-NRS score.||Difference from vehicle cream at Week 12||||<0.001
72464748|NCT03638258|144451873|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.|||||<|0.001|||||||Regression, Logistic|Logistic regression with a factor of treatment group and a covariate of baseline WI-NRS score.||Difference from vehicle cream at Week 12||||<0.001
72464749|NCT03638258|144451874|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.||||||0.527|||||||Regression, Logistic|Logistic regression (Firth's penalized likelihood) with a factor of treatment group and a covariate of baseline PASI score.||Difference from vehicle cream at Week 4||||0.527
72564031|NCT01115855|144659695|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.77|||||TWO_SIDED|95.0|0.81|3.87||||||Cox Proportional Hazard Model with baseline NYHA cohort (II, III/IV) and baseline eGFR (30--\<50 ml/min/1.73 m\^2, \>-=50 ml/min/1.73 m\^2) covariates.||3.87|0.81|
72564032|NCT01115855|144659696|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|2.4|||||TWO_SIDED|95.0|0.92|6.24||||||Cox Proportional Hazard Model with baseline NYHA cohort (II, III/IV) and baseline eGFR (30--\<50 ml/min/1.73 m\^2, \>-=50 ml/min/1.73 m\^2) covariates.||6.24|0.92|
72564033|NCT01115855|144659697|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.65|||||TWO_SIDED|95.0|0.44|0.97||||||Cox Proportional Hazard Model with baseline NYHA cohort (II, III/IV) and baseline eGFR (30--\<50 ml/min/1.73 m\^2, \>-=50 ml/min/1.73 m\^2) covariates.||0.97|0.44|
72464750|NCT03638258|144451874|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.||||||0.444|||||||Regression, Logistic|Logistic regression (Firth's penalized likelihood) with a factor of treatment group and a covariate of baseline PASI score.||Difference from vehicle cream at Week 4||||0.444
72464751|NCT03638258|144451874|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.||||||0.006|||||||Regression, Logistic|Logistic regression (Firth's penalized likelihood) with a factor of treatment group and a covariate of baseline PASI score.||Difference from vehicle cream at Week 6||||0.006
72464752|NCT03638258|144451874|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.||||||0.013|||||||Regression, Logistic|Logistic regression (Firth's penalized likelihood) with a factor of treatment group and a covariate of baseline PASI score.||Difference from vehicle cream at Week 6||||0.013
72464753|NCT03638258|144451874|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.||||||0.002|||||||Regression, Logistic|Logistic regression (Firth's penalized likelihood) with a factor of treatment group and a covariate of baseline PASI score.||Difference from vehicle cream at Week 8||||0.002
72464754|NCT03638258|144451874|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.||||||0.064|||||||Regression, Logistic|Logistic regression (Firth's penalized likelihood) with a factor of treatment group and a covariate of baseline PASI score.||Difference from vehicle cream at Week 8||||0.064
72464755|NCT03638258|144451874|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.||||||0.002|||||||Regression, Logistic|Logistic regression (Firth's penalized likelihood) with a factor of treatment group and a covariate of baseline PASI score.||Difference from vehicle cream at Week 12||||0.002
72464756|NCT03638258|144451874|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.||||||0.009|||||||Regression, Logistic|Logistic regression (Firth's penalized likelihood) with a factor of treatment group and a covariate of baseline PASI score.||Difference from vehicle cream at Week 12||||0.009
72464757|NCT03638258|144451875|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.||||||0.188|||||||Regression, Logistic|Logistic regression (Firth's penalized likelihood) with a factor of treatment group and a covariate of baseline PASI score.||Difference from vehicle cream at Week 4||||0.188
72464758|NCT03638258|144451875|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.||||||0.577|||||||Regression, Logistic|Logistic regression (Firth's penalized likelihood) with a factor of treatment group and a covariate of baseline PASI score.||Difference from vehicle cream at Week 4||||0.577
72464759|NCT03638258|144451875|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.||||||0.008|||||||Regression, Logistic|Logistic regression (Firth's penalized likelihood) with a factor of treatment group and a covariate of baseline PASI score.||Difference from vehicle cream at Week 6||||0.008
72464760|NCT03638258|144451875|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.||||||0.664|||||||Regression, Logistic|Logistic regression (Firth's penalized likelihood) with a factor of treatment group and a covariate of baseline PASI score.||Difference from vehicle cream at Week 6||||0.664
72464761|NCT03638258|144451875|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.||||||0.015|||||||Regression, Logistic|Logistic regression (Firth's penalized likelihood) with a factor of treatment group and a covariate of baseline PASI score.||Difference from vehicle cream at Week 8||||0.015
72464762|NCT03638258|144451875|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.||||||0.666|||||||Regression, Logistic|Logistic regression (Firth's penalized likelihood) with a factor of treatment group and a covariate of baseline PASI score.||Difference from vehicle cream at Week 8||||0.666
72464763|NCT03638258|144451875|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.||||||0.009|||||||Regression, Logistic|Logistic regression (Firth's penalized likelihood) with a factor of treatment group and a covariate of baseline PASI score.||Difference from vehicle cream at Week 12||||0.009
72464764|NCT03638258|144451875|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.||||||0.163|||||||Regression, Logistic|Logistic regression (Firth's penalized likelihood) with a factor of treatment group and a covariate of baseline PASI score.||Difference from vehicle cream at Week 12||||0.163
72464765|NCT03638258|144451876|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible. ANCOVA with a factor of treatment group and a covariate of baseline PSD score.||||||0.002|||||||ANOVA|ANCOVA with a factor of treatment group and a covariate of baseline PSD score.||Difference from vehicle cream on Week 4||||0.002
72464766|NCT03638258|144451876|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.||||||0.002|||||||ANCOVA|ANCOVA with a factor of treatment group and a covariate of baseline PSD score.||Difference from vehicle cream at Week 4||||0.002
72464767|NCT03638258|144451876|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.|||||<|0.001|||||||ANCOVA|ANCOVA with a factor of treatment group and a covariate of baseline PSD score.||Difference from vehicle cream at Week 6||||<0.001
72464768|NCT03638258|144451876|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.|||||<|0.001|||||||ANCOVA|ANCOVA with a factor of treatment group and a covariate of baseline PSD score.||Difference from placebo at Week 6||||<0.001
72464769|NCT03638258|144451876|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.|||||<|0.001|||||||ANCOVA|ANCOVA with a factor of treatment group and a covariate of baseline PSD score.||Difference from placebo at Week 8||||<0.001
72464770|NCT03638258|144451876|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.|||||<|0.001|||||||ANCOVA|ANCOVA with a factor of treatment group and a covariate of baseline PSD score.||Difference from vehicle cream at Week 8||||<0.001
72464771|NCT03638258|144451876|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.|||||<|0.001|||||||ANCOVA|ANCOVA with a factor of treatment group and a covariate of baseline PSD score.||Difference from vehicle cream at Week 12||||<0.001
72564034|NCT01115855|144659698|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.75|||||TWO_SIDED|95.0|0.45|1.25||||||Cox Proportional Hazard Model with baseline NYHA cohort (II, III/IV) and baseline eGFR (30--\<50 ml/min/1.73 m\^2, \>-=50 ml/min/1.73 m\^2) covariates.||1.25|0.45|
72564035|NCT01115855|144659699|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.66|||||TWO_SIDED|95.0|0.45|0.97||||||Cox Proportional Hazard Model with baseline NYHA cohort (II, III/IV) and baseline eGFR (30--\<50 ml/min/1.73 m\^2, \>-=50 ml/min/1.73 m\^2) covariates.||0.97|0.45|
72464772|NCT03638258|144451876|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.|||||<|0.001|||||||ANCOVA|ANCOVA with a factor of treatment group and a covariate of baseline PSD score.||Difference from vehicle cream at Week 12||||<0.001
72464773|NCT03638258|144451877|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.||||||0.184|||||||ANCOVA|ANCOVA with a factor of treatment group and a covariate of baseline Itch-Related Sleep Loss score.||Difference from vehicle cream at Week 4||||0.184
72464774|NCT03638258|144451877|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.||||||0.207|||||||ANCOVA|ANCOVA with a factor of treatment group and a covariate of baseline Itch-Related Sleep Loss NRS score.||Difference from placebo at Week 4||||0.207
72464775|NCT03638258|144451877|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.||||||0.004|||||||ANCOVA|ANCOVA with a factor of treatment group and a covariate of baseline Itch-Related Sleep Loss NRS score.||Difference from vehicle cream at Week 6||||0.004
72464776|NCT03638258|144451877|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.||||||0.022|||||||ANCOVA|ANCOVA with a factor of treatment group and a covariate of baseline Itch-Related Sleep Loss NRS score.||Difference from vehicle cream at Week 6||||0.022
72621304|NCT02732145|144773191|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of Mons Pubis versus non-specific lesions of Labia Majora in patients with vulvar dermatosis?||||||0.0014|||||||t-test proportion|||Parameter: The difference in the incidence of non-specific lesions of Mons Pubis versus non-specific lesions of Labia Majora in patients with vulvar dermatosis.||||0.0014
72464777|NCT03638258|144451877|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.||||||0.003|||||||ANCOVA|ANCOVA with a factor of treatment group and a covariate of baseline Itch-Related Sleep Loss NRS score.||Difference from vehicle cream at Week 8||||0.003
72464778|NCT03638258|144451877|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.|||||<|0.001|||||||ANCOVA|ANCOVA with a factor of treatment group and a covariate of baseline Itch-Related Sleep Loss NRS score.||Difference from vehicle cream at Week 8||||<0.001
72464779|NCT03638258|144451877|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible. ANCOVA with a factor of treatment group and a covariate of baseline Itch-Related Sleep Loss NRS score.||||||0.003|||||||ANCOVA|ANCOVA with a factor of treatment group and a covariate of baseline Itch-Related Sleep Loss NRS score.||Difference from vehicle cream at Week 12||||0.003
72464780|NCT03638258|144451877|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.||||||0.01||||||ANCOVA with a factor of treatment group and a covariate of baseline Itch-Related Sleep Loss NRS score.|ANCOVA|||Difference from vehicle cream at Week 12||||0.01
72464781|NCT03638258|144451878|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.||||||0.255|||||||ANCOVA|ANCOVA with a factor of treatment group and a covariate of baseline DLQI score.||Difference from vehicle cream at Week 4||||0.255
72464782|NCT03638258|144451878|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.||||||0.687|||||||ANCOVA|ANCOVA with a factor of treatment group and a covariate of baseline DLQI score.||Difference from vehicle cream on Week 4||||0.687
72464783|NCT03638258|144451878|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.||||||0.045|||||||ANCOVA|ANCOVA with a factor of treatment group and a covariate of baseline DLQI score.||Difference from vehicle cream at Week 6||||0.045
72464784|NCT03638258|144451878|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.||||||0.059|||||||ANCOVA|ANCOVA with a factor of treatment group and a covariate of baseline DLQI score.||Difference from vehicle cream at Week 6||||0.059
72464785|NCT03638258|144451878|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.||||||0.051|||||||ANCOVA|ANCOVA with a factor of treatment group and a covariate of baseline DLQI score.||Difference from vehicle cream at Week 8||||0.051
72464786|NCT03638258|144451878|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.||||||0.013|||||||ANCOVA|ANCOVA with a factor of treatment group and a covariate of baseline DLQI score.||Difference from vehicle cream at Week 8||||0.013
72464787|NCT03638258|144451878|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.||||||0.036|||||||ANCOVA|ANCOVA with a factor of treatment group and a covariate of baseline DLQI score.||Difference from vehicle cream at Week 12||||0.036
72502465|NCT01740362|144535487|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|222.71|||||TWO_SIDED|90.0|157.02|315.89||||||One way ANOVA on natural log-transformed AUC (0 - ∞) were analyzed using linear model containing degrees of renal impairment (CLcr, discrete) calculated using blood samples collected at screening as fixed effects. SAS procedure PROC MIXED was used for analysis. Anti-log of the adjusted mean difference (CP-690,550 \[severe renal insufficiency\] - CP-690,550 \[normal renal function\]) and its corresponding 90% CI were taken to estimate the mean ratio and corresponding 90% CI.||315.89|157.02|
72464788|NCT03638258|144451878|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.||||||0.001|||||||ANCOVA|ANCOVA with a factor of treatment group and a covariate of baseline DLQI score.||Difference from vehicle cream at Week 12||||0.001
72621305|NCT02732145|144773191|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of Mons Pubis versus non-specific lesions of the Perineum in patients with vulvar dermatosis?||||||0|||||||t-test proportion|||Parameter: The difference in the incidence of non-specific lesions of Mons Pubis versus non-specific lesions of the Perineum in patients with vulvar dermatosis.||||0.0000
72464789|NCT02630706|144451880|SUPERIORITY|Constrained longitudinal data analysis (cLDA)|Difference in the LSM vs. placebo|-0.69|||<|0.001|TWO_SIDED|95.0|-0.85|-0.52||cLDA model with fixed effects for treatment, time, anti-AHA status at Screening (metformin alone, metformin + another AHA), country (China, other), baseline eGFR (continuous) and the interaction of time by treatment.|cLDA|Least squares means = LSM||The primary hypothesis of the study was the mean change from baseline in HbA1c for 15 mg ertugliflozin is greater than that for placebo.||-0.52|-0.85|<0.001
72621306|NCT02732145|144773191|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of Labia Majora versus non-specific lesions of the Perineum in patients with vulvar dermatosis?||||||0.0414|||||||t-test proportion|||Parameter: The difference in the incidence of non-specific lesion of Labia Majora versus non-specific lesions of the Perineum in patients with vulvar dermatosis.||||0.0414
72621307|NCT02732145|144773191|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of Mons Pubis versus non-specific lesions of Labia Majora in patients with vulvodynia?||||||0.0898|||||||t-test proportion|||"Parameter: The difference in the incidence of non-specific lesions of Mons Pubis versus non-specific lesions of Labia Majora in patients with vulvodynia.~The diagnosis of vulvodynia was based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection, Q-Tip) following Friedrich's criteria. Vulvoscopic lesions were not relevant to the diagnosis of vulvodynia."||||0.0898
72621308|NCT02732145|144773191|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of Mons Pubis versus non-specific lesions of the Perineum in patients with vulvodynia?||||||0.0008|||||||t-test proportion|||"Parameter: The difference in the incidence of non-specific lesions of Mons Pubis versus non-specific lesions of the Perineum in patients with vulvodynia.~The diagnosis of vulvodynia was based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection, Q-Tip) following Friedrich's criteria. Vulvoscopic lesions were not relevant to the diagnosis of vulvodynia."||||0.0008
72621309|NCT02732145|144773191|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of Labia Majora versus non-specific lesions of the Perineum in patients with vulvodynia?||||||0.0587|||||||t-test proportion|||"Parameter: The difference in the incidence of non-specific lesions of Labia Majora versus non-specific lesions of the Perineum in patients with vulvodynia.~The diagnosis of vulvodynia was based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection, Q-Tip) following Friedrich's criteria. Vulvoscopic lesions were not relevant to the diagnosis of vulvodynia."||||0.0587
72621310|NCT02732145|144773191|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of Mons Pubis versus non-specific lesions of Labia Majora in patients with impaired vulvar skin?||||||1|||||||t-test proportion|||Parameter: The difference in the incidence of non-specific lesions of Mons Pubis versus non-specific lesions of Labia Majora in patients with impaired vulvar skin.||||1.0000
72621311|NCT02732145|144773191|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of Mons Pubis versus non-specific lesions of the Perineum in patients with impaired vulvar skin?||||||0.1352|||||||t-test proportion|||Parameter: The difference in the incidence of non-specific lesions of Mons Pubis versus non-specific lesions of the Perineum in patients with impaired vulvar skin.||||0.1352
72393979|NCT01059825|144294288|SUPERIORITY_OR_OTHER||Difference in least squares means|-2.87||||0.097|TWO_SIDED|80.0|-5.69|-0.04||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-0.04|-5.69|0.097
72393980|NCT01059825|144294288|SUPERIORITY_OR_OTHER||Difference in least squares means|-2.0||||0.179|TWO_SIDED|80.0|-4.78|0.79||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||0.79|-4.78|0.179
72393981|NCT01059825|144294290|SUPERIORITY_OR_OTHER||Difference in least squares means|-1.93||||0.072|TWO_SIDED|80.0|-3.62|-0.24||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-0.24|-3.62|0.072
72464790|NCT02630706|144451880|SUPERIORITY|cLDA model with fixed effects for treatment, time, anti-AHA status at Screening (metformin alone, metformin + another AHA), country (China, other), baseline eGFR (continuous) and the interaction of time by treatment.|Difference in the LS Means vs. Placebo|-0.8|||<|0.001|TWO_SIDED|95.0|-0.97|-0.63|||cLDA|||The primary hypothesis of the study was the mean change from baseline in HbA1c for 5 mg ertugliflozin is greater than that for placebo.||-0.63|-0.97|<0.001
72393982|NCT01059825|144294290|SUPERIORITY_OR_OTHER||Difference in least squares means|-1.81||||0.086|TWO_SIDED|80.0|-3.51|-0.11||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-0.11|-3.51|0.086
72464791|NCT02630706|144451881|SUPERIORITY||Difference in the LSM vs. placebo|-0.68|||<|0.001|TWO_SIDED|95.0|-0.86|-0.5||cLDA model with fixed effects for treatment, time, anti-AHA status at Screening (metformin alone, metformin + another AHA), baseline eGFR (continuous) and the interaction of time by treatment.|cLDA|||||-0.50|-0.86|<0.001
72464792|NCT02630706|144451881|SUPERIORITY|cLDA model with fixed effects for treatment, time, anti-AHA status at Screening (metformin alone, metformin + another AHA), baseline eGFR (continuous) and the interaction of time by treatment.|Difference in the LS Means vs. Placebo|-0.76|||<|0.001|TWO_SIDED|95.0|-0.95|-0.58|||cLDA|||||-0.58|-0.95|<0.001
72464793|NCT02630706|144451882|OTHER||Difference in % vs. Placebo|-6.0|||||TWO_SIDED|95.0|-16.5|4.6|||||||Miettinen-Nurminen method|4.6|-16.5|
72464794|NCT02630706|144451882|OTHER||Difference in % vs. Placebo|-2.8|||||TWO_SIDED|95.0|-13.3|7.7|||||||Miettinen-Nurminen method|7.7|-13.3|
72464795|NCT02630706|144451883|OTHER||Difference in % vs. Placebo|-8.9|||||TWO_SIDED|95.0|-20.5|3.0|||||||Miettinen-Nurminen method|3.0|-20.5|
72621312|NCT02732145|144773191|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of Labia Majora versus non-specific lesions of the Perineum in patients with impaired vulvar skin?||||||0.1352|||||||t-test proportion|||Parameter: The difference in the incidence of non-specific lesion of Labia Majora versus non-specific lesions of the Perineum in patients with impaired vulvar skin.||||0.1352
72621313|NCT02732145|144773191|SUPERIORITY|Question: Is there a difference in the incidence of specific lesions of Mons Pubis versus specific lesions of Labia Majora in patients with vulvar dermatosis?||||||0.0002|||||||t-test proportion|||Parameter: The difference in the incidence of specific lesions of Mons Pubis versus specific lesions of Labia Majora in patients with vulvar dermatosis.||||0.0002
72464796|NCT02630706|144451883|OTHER||Difference in % vs. Placebo|-4.8|||||TWO_SIDED|95.0|-16.5|6.9|||||||Miettinen-Nurminen method|6.9|-16.5|
72464797|NCT02630706|144451886|SUPERIORITY|cLDA model with fixed effects for treatment, time, anti-hyperglycemic medication status at Screening (metformin alone, metformin + another AHA), Country (China, other), baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.|Difference in LS Means vs. Placebo|-27.78|||<|0.001|TWO_SIDED|95.0|-33.85|-21.7|||cLDA|||||-21.70|-33.85|<0.001
72464798|NCT02630706|144451886|SUPERIORITY|cLDA model with fixed effects for treatment, time, anti-hyperglycemic medication status at Screening (metformin alone, metformin + another AHA), Country (China, other), baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.|Difference in LS Means vs. Placebo|-30.4|||<|0.001|TWO_SIDED|95.0|-36.45|-24.35|||cLDA|||||-24.35|-36.45|<0.001
72464799|NCT02630706|144451887|SUPERIORITY|cLDA model with fixed effects for treatment, time, anti-hyperglycemic medication status at Screening (metformin alone, metformin + another AHA), baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.|Difference in LS Means vs. Placebo|-26.21|||<|0.001|TWO_SIDED|95.0|-32.41|-20.01|||cLDA|||||-20.01|-32.41|<0.001
72464800|NCT02630706|144451887|SUPERIORITY|cLDA model with fixed effects for treatment, time, anti-hyperglycemic medication status at Screening (metformin alone, metformin + another AHA), baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.|Difference in LS Means vs. Placebo|-28.55|||<|0.001|TWO_SIDED|95.0|-34.67|-22.43|||cLDA|||||-22.43|-34.67|<0.001
72464801|NCT02630706|144451888|SUPERIORITY|cLDA model with fixed effects for treatment, time, anti-hyperglycemic medication status at Screening (metformin alone, metformin + another AHA), Country (China, other), baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.|Difference in LS Means vs. Placebo|-2.0|||<|0.001|TWO_SIDED|95.0|-2.51|-1.5|||cLDA|||||-1.50|-2.51|<0.001
72464802|NCT02630706|144451888|SUPERIORITY|cLDA model with fixed effects for treatment, time, anti-hyperglycemic medication status at Screening (metformin alone, metformin + another AHA), Country (China, other), baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.|Difference in the LS Means vs. Placebo|-1.78|||<|0.001|TWO_SIDED|95.0|-2.28|-1.28|||cLDA|||||-1.28|-2.28|<0.001
72621314|NCT02732145|144773191|SUPERIORITY|Question: Is there a difference in the incidence of specific lesions of Mons Pubis versus specific lesions of the Perineum in patients with vulvar dermatosis?||||||0|||||||t-test proportion|||Parameter: The difference in the incidence of specific lesions of Mons Pubis versus specific lesions of the Perineum in patients with vulvar dermatosis.||||0.0000
72464803|NCT02630706|144451889|SUPERIORITY|cLDA model with fixed effects for treatment, time, anti-hyperglycemic medication status at Screening (metformin alone, metformin + another AHA), baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.|Difference in LS Means vs. Placebo|-2.05|||<|0.001|TWO_SIDED|95.0|-2.63|-1.21|||cLDA|||||-1.21|-2.63|<0.001
72464804|NCT02630706|144451889|SUPERIORITY|cLDA model with fixed effects for treatment, time, anti-hyperglycemic medication status at Screening (metformin alone, metformin + another AHA), baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.|Difference in the LS Means vs. Placebo|-1.79|||<|0.001|TWO_SIDED|95.0|-2.36|-1.21|||cLDA|||||-1.21|-2.36|<0.001
72464805|NCT02630706|144451890|SUPERIORITY|Adjusted odds ratio based on a logistic regression model fitted with fixed effects for treatment anti-hyperglycemic medication status at screening (metformin alone, metformin + another AHA), Country (China, other), baseline eGFR (continuous) and baseline A1C (continuous). Missing data imputed using the cLDA model fitted with fixed effects as in the primary analysis.|Adjusted Odds Ratio relative to placebo|4.56|||<|0.001|TWO_SIDED|95.0|2.49|8.35|||Logistic regression model|||||8.35|2.49|<0.001
72464806|NCT02630706|144451890|SUPERIORITY|Adjusted odds ratio based on a logistic regression model fitted with fixed effects for treatment anti-hyperglycemic medication status at screening (metformin alone, metformin + another AHA), Country (China, other), baseline eGFR (continuous) and baseline A1C (continuous). Missing data imputed using the cLDA model fitted with fixed effects as in the primary analysis.|Adjusted Odds Ratio relative to placebo|4.59|||<|0.001|TWO_SIDED|95.0|2.52|8.36|||Logistic regression model|||||8.36|2.52|<0.001
72464807|NCT02630706|144451891|SUPERIORITY|Adjusted odds ratio based on a logistic regression model fitted with fixed effects for treatment anti-hyperglycemic medication status at screening (metformin alone, metformin + another AHA), baseline eGFR (continuous) and baseline A1C (continuous). Missing data imputed using the cLDA model fitted with fixed effects as in the primary analysis.|Adjusted Odds Ratio relative to placebo|4.49|||<|0.001|TWO_SIDED|95.0|2.32|8.68|||Logistic regression model|||||8.68|2.32|<0.001
72464808|NCT02630706|144451891|SUPERIORITY|Adjusted odds ratio based on a logistic regression model fitted with fixed effects for treatment anti-hyperglycemic medication status at screening (metformin alone, metformin + another AHA), baseline eGFR (continuous) and baseline A1C (continuous). Missing data imputed using the cLDA model fitted with fixed effects as in the primary analysis.|Adjusted Odds Ratio relative to placebo|3.47|||<|0.001|TWO_SIDED|95.0|1.77|6.8|||Logistic regression model|||||6.80|1.77|<0.001
72464809|NCT02630706|144451892|SUPERIORITY|cLDA model with fixed effects for treatment, time, anti-hyperglycemic medication status at Screening (metformin alone, metformin + another AHA), Country (China, other), baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.|Difference in the LS Means vs. Placebo|-4.09|||<|0.001|TWO_SIDED|95.0|-6.48|-1.69|||cLDA|||||-1.69|-6.48|<0.001
72464810|NCT02630706|144451892|SUPERIORITY|cLDA model with fixed effects for treatment, time, anti-hyperglycemic medication status at Screening (metformin alone, metformin + another AHA), Country (China, other), baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.|Difference in the LS Means vs. Placebo|-5.3|||<|0.001|TWO_SIDED|95.0|-7.68|-2.92|||cLDA|||||-2.92|-7.68|<0.001
72464811|NCT02630706|144451893|SUPERIORITY|cLDA model with fixed effects for treatment, time, anti-hyperglycemic medication status at Screening (metformin alone, metformin + another AHA), baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.|Difference in the LS Means vs. Placebo|-2.64||||0.058|TWO_SIDED|95.0|-5.36|0.09|||cLDA|||||0.09|-5.36|0.058
72464812|NCT02630706|144451893|SUPERIORITY|cLDA model with fixed effects for treatment, time, anti-hyperglycemic medication status at Screening (metformin alone, metformin + another AHA), baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.|Difference in the LS Means vs. Placebo|-4.08||||0.003|TWO_SIDED|95.0|-6.78|-1.39|||cLDA|||||-1.39|-6.78|0.003
72393983|NCT01059825|144294290|SUPERIORITY_OR_OTHER||Difference in least squares means|-3.99||||0.002|TWO_SIDED|80.0|-5.71|-2.27||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-2.27|-5.71|0.002
72464813|NCT02630706|144451894|SUPERIORITY|cLDA model with fixed effects for treatment, time, anti-hyperglycemic medication status at Screening (metformin alone, metformin + another AHA), Country (China, other), baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.|Difference in the LS Means vs. Placebo|-1.4||||0.086|TWO_SIDED|95.0|-3.0|0.2|||cLDA|||||0.20|-3.00|0.086
72464814|NCT02630706|144451894|SUPERIORITY|cLDA model with fixed effects for treatment, time, anti-hyperglycemic medication status at Screening (metformin alone, metformin + another AHA), Country (China, other), baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.|Difference in the LS Means vs. Placebo|-1.42||||0.081|TWO_SIDED|95.0|-3.01|0.17|||cLDA|||||0.17|-3.01|0.081
72464815|NCT02630706|144451895|SUPERIORITY|cLDA model with fixed effects for treatment, time, anti-hyperglycemic medication status at Screening (metformin alone, metformin + another AHA), baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.|Difference in the LS Means vs. Placebo|-0.95||||0.315|TWO_SIDED|95.0|-2.8|0.9|||cLDA|||||0.90|-2.80|0.315
72464816|NCT02630706|144451895|SUPERIORITY|cLDA model with fixed effects for treatment, time, anti-hyperglycemic medication status at Screening (metformin alone, metformin + another AHA), baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.|Difference in the LS Means vs. Placebo|-1.0||||0.282|TWO_SIDED|95.0|-2.83|0.83|||cLDA|||||0.83|-2.83|0.282
72464817|NCT02630706|144451896|SUPERIORITY|Adjusted odds ratio based on a logistic regression model fitted with fixed effects for treatment anti-hyperglycemic medication status at screening (metformin alone, metformin + another AHA), Country (China, other), baseline eGFR (continuous) and baseline A1C (continuous). Missing data imputed using the cLDA model fitted with fixed effects as in the primary analysis.|Adjusted Odds Ratio relative to placebo|8.9||||0.001|TWO_SIDED|95.0|2.46|32.22||Nominal p-values were provided.|Logistic regression model|||||32.22|2.46|0.001
72464818|NCT02630706|144451896|SUPERIORITY|Adjusted odds ratio based on a logistic regression model fitted with fixed effects for treatment anti-hyperglycemic medication status at screening (metformin alone, metformin + another AHA), Country (China, other), baseline eGFR (continuous) and baseline A1C (continuous). Missing data imputed using the cLDA model fitted with fixed effects as in the primary analysis.|Adjusted Odds Ratio relative to placebo|10.69|||<|0.001|TWO_SIDED|95.0|2.95|38.71||Nominal p-values were provided.|Logistic regression model|||||38.71|2.95|<0.001
72464819|NCT02630706|144451897|SUPERIORITY|Adjusted Odds Ratio based on a logistic regression model fitted with fixed effects for treatment anti-hyperglycemic medication status at screening (metformin alone, metformin + another AHA), Country (China, other), baseline eGFR (continuous) and baseline A1C (continuous). Missing data imputed using the cLDA model fitted with fixed effects as in the primary analysis.|Adjusted Odds Ratio relative to placebo|8.34|||<|0.001|TWO_SIDED|95.0|2.52|27.6||Nominal p-values were provided.|Logistic regression model|||||27.60|2.52|<0.001
72464820|NCT02630706|144451897|SUPERIORITY|Adjusted odds ratio based on a logistic regression model fitted with fixed effects for treatment, anti-hyperglycemic medication status at screening (metformin alone, metformin + another AHA), baseline eGFR (continuous) and baseline A1C (continuous). Missing data imputed using the cLDA model fitted with fixed effects as in the primary analysis.|Adjusted Odds Ratio relative to placebo|8.29|||<|0.001|TWO_SIDED|95.0|2.44|28.11||Nominal p-values were provided.|Logistic regression model|||||28.11|2.44|<0.001
72464821|NCT02630706|144451898|OTHER||Difference in % (Ert. 15 mg. - placebo)|-9.0|||<|0.001||95.0|-14.5|-5.0|||Miettinen & Nurminen method|Miettinen \& Nurminen method stratified by country ('China' or 'other') for the overall population.||||-5.0|-14.5|<0.001
72464822|NCT02630706|144451898|OTHER||Difference in % (Ert. 5 mg. - placebo)|-8.4|||<|0.001|TWO_SIDED|95.0|-14.0|-4.4|||Miettinen & Nurminen method|Miettinen \& Nurminen method stratified by country ('China' or 'other') for the overall population.||||-4.4|-14.0|<0.001
72464823|NCT02630706|144451899|OTHER||Difference in % (Ert. 15 mg. - placebo)|-8.9||||0.001||95.0|-15.1|-4.2|||Miettinen & Nurminen method|||||-4.2|-15.1|0.001
72464824|NCT02630706|144451899|OTHER||Difference in % (Ert. 5 mg. - placebo)|-9.6|||<|0.001|TWO_SIDED|95.0|-15.8|-5.7|||Miettinen & Nurminen method|||||-5.7|-15.8|<0.001
72464825|NCT03790878|144451960|OTHER|||||||0.018|||||||ANCOVA|||||||0.018
72464826|NCT03790878|144451961|OTHER|||||||0.396|||||||Multilevel modeling|||||||0.396
72464827|NCT03790878|144451962|OTHER|||||||0.002|||||||Multilevel modeling|||||||0.002
72464828|NCT01180790|144452022|SUPERIORITY_OR_OTHER_LEGACY|||||||0.003||||||To control for multiplicity, the proportion in each treatment group achieving RVR4 is analyzed using a Cochran-Armitage test for trend among the ordered groups: placebo (considered zero dose), 200 mg, 400 mg, and 800 mg ACH-0141625.|exact Cochran-Armitage test|Only if overall test for trend is significant are pairwise comparisons evaluated using p-values for the difference in proportions (placebo - active).||The null hypothesis is no difference between proportions of participants in each treatment group achieving RVR4 at Week 4 of the study, while the alternative hypothesis is that the proportion of participants achieving RVR4 at Week 4 increases with increasing doses of ACH-0141625.||||0.003
72464829|NCT01180790|144452022|SUPERIORITY_OR_OTHER_LEGACY|||||||0.004|||||||Fisher Exact|||To control for multiplicity, the proportion in each treatment group achieving RVR4 is analyzed using a Cochran-Armitage test for trend among the ordered groups: placebo (considered zero dose), 200 mg ACH-0141625, 400 mg ACH-0141625, and 800 mg ACH-0141625. Only if overall test for trend is significant are pairwise comparisons evaluated using p-values for the difference in proportions (placebo - active).||||0.004
72464830|NCT01180790|144452022|SUPERIORITY_OR_OTHER_LEGACY|||||||0.004|||||||Fisher Exact|||To control for multiplicity, the proportion in each treatment group achieving RVR4 is analyzed using a Cochran-Armitage test for trend among the ordered groups: placebo (considered zero dose), 200 mg ACH-0141625, 400 mg ACH-0141625, and 800 mg ACH-0141625. Only if overall test for trend is significant are pairwise comparisons evaluated using p-values for the difference in proportions (placebo - active).||||0.004
72621315|NCT02732145|144773191|SUPERIORITY|Question: Is there a difference in the incidence of specific lesions of Labia Majora versus specific lesions of the Perineum in patients with vulvar dermatosis?||||||0.0854|||||||t-test proportion|||Parameter: The difference in the incidence of specific lesions of Labia Majora versus specific lesions of the Perineum in patients with vulvar dermatosis.||||0.0854
72464831|NCT01180790|144452022|SUPERIORITY_OR_OTHER_LEGACY|||||||0.004|||||||Fisher Exact|||To control for multiplicity, the proportion in each treatment group achieving RVR4 is analyzed using a Cochran-Armitage test for trend among the ordered groups: placebo (considered zero dose), 200 mg ACH-0141625, 400 mg ACH-0141625, and 800 mg ACH-0141625. Only if overall test for trend is significant are pairwise comparisons evaluated using p-values for the difference in proportions (placebo - active).||||0.004
72502466|NCT01740362|144535488|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric mean|93.15|||||TWO_SIDED|90.0|67.22|129.06||||||One way ANOVA on natural log-transformed Cmax were analyzed using linear model containing degrees of renal impairment (CLcr, discrete) calculated using blood samples collected at screening as fixed effects. SAS procedure PROC MIXED was used for analysis. Anti-log of the adjusted mean difference (CP-690,550 \[mild renal insufficiency\] - CP-690,550 \[normal renal function\]) and its corresponding 90% CI were taken to estimate the mean ratio and corresponding 90% CI.||129.06|67.22|
72464832|NCT01180790|144452024|SUPERIORITY_OR_OTHER_LEGACY|||||||0.34||||||To control for multiplicity, the proportion of participants in each treatment group achieving cEVR is analyzed using a Cochran-Armitage test for trend among the ordered treatment groups: 200 mg ACH-0141625, 400 mg ACH-0141625, and 800 mg ACH-0141625.|Exact Cochran-Armitage test|Only if overall test for trend is significant are pairwise comparisons evaluated using p-values for the difference in proportions (placebo - active).||The null hypothesis is no difference between proportions of participants in each treatment group achieving cEVR at Week 12 of the study, while the alternative hypothesis is that the proportion of participants achieving cEVR at Week 12 increases with increasing doses of ACH-0141625.||||0.34
72464833|NCT01064856|144452036|SUPERIORITY_OR_OTHER_LEGACY|||||||0.006|||||||Pearson's chi-square|||||||0.006
72464834|NCT01064856|144452038|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||ANCOVA|The P-value was based on an ANCOVA model adjusting for baseline with treatment as a factor.||||||<0.001
72464835|NCT01064856|144452039|SUPERIORITY_OR_OTHER_LEGACY|||||||0.003|||||||ANCOVA|The P-value was based on an ANCOVA model adjusting for baseline with treatment as a factor.||||||0.003
72464836|NCT01064856|144452040|SUPERIORITY_OR_OTHER_LEGACY|||||||0.051|||||||ANCOVA|The P-value was based on an ANCOVA model adjusting for baseline with treatment as a factor.||||||0.051
72464837|NCT03302559|144452069|OTHER|Testing hypothesis is that the mean change from baseline is zero.|||||<|0.001||||||Statistical significance is defined as a p-value ≤0.05.|Paired t-test|||Change from Baseline at Week 12||||<0.001
72464838|NCT03302559|144452070|OTHER|Testing hypothesis is that the mean change from baseline is zero.||||||0.005||||||Statistical significance is defined as a p-value ≤0.05.|Paired t-test|||Change from Baseline at Week 12 (Forehead)||||0.005
72464839|NCT03302559|144452070|OTHER|Testing hypothesis is that the mean change from baseline is zero.||||||0.02||||||Statistical significance is defined as a p-value ≤0.05.|Paired t-test|||Change from Baseline at Week 12 (Periocular)||||0.02
72464840|NCT03302559|144452070|OTHER|Testing hypothesis is that the mean change from baseline is zero.||||||0.0006||||||Statistical significance is defined as a p-value ≤0.05.|Paired t-test|||Change from Baseline at Week 12 (Cheeks)||||0.0006
72464841|NCT03302559|144452070|OTHER|Testing hypothesis is that the mean change from baseline is zero||||||0.001||||||Statistical significance is defined as a p-value ≤0.05.|Paired t-test|||Change from Baseline at Week 12 (Perioral)||||0.001
72464842|NCT03302559|144452071|OTHER|Testing hypothesis is that the mean change from baseline is zero.||||||0.02||||||Statistical significance is defined as a p-value ≤0.05.|Paired t-test|||Change from Baseline at Week 12 (Forehead)||||0.02
72464843|NCT03302559|144452071|OTHER|Testing hypothesis is that the mean change from baseline is zero.||||||0.006||||||Statistical significance is defined as a p-value ≤0.05.|Paired t-test|||Change from Baseline at Week 12 (Periocular)||||0.006
72464844|NCT03302559|144452071|OTHER|Testing hypothesis is that the mean change from baseline is zero.|||||<|0.001||||||Statistical significance is defined as a p-value ≤0.05.|Paired t-test|||Change from Baseline at Week 12 (Cheeks)||||<0.001
72464845|NCT03302559|144452071|OTHER|Testing hypothesis is that the mean change from baseline is zero.||||||0.5||||||Statistical significance is defined as a p-value ≤0.05.|Paired t-test|||Change from Baseline at Week 12 (Perioral)||||0.5
72464846|NCT03302559|144452072|OTHER|Testing hypothesis is that the mean change from baseline is zero.||||||0.002||||||Statistical significance is defined as a p-value ≤0.05.|Paired t-test|||Change from Baseline at Week 12||||0.002
72464847|NCT03302559|144452073|OTHER|Testing hypothesis is that the mean change from baseline is zero.||||||0.0008||||||Statistical significance is defined as a p-value ≤0.05.|Paired t-test|||Change from Baseline at Week 12||||0.0008
72464848|NCT03302559|144452074|OTHER|Testing hypothesis is that the mean change from baseline is zero.||||||0.02||||||Statistical significance is defined as a p-value ≤0.05.|Paired t-test|||Change from Baseline at Week 12||||0.02
72464849|NCT03302559|144452079|OTHER|Testing hypothesis is that the mean change from baseline is zero.||||||0.3||||||Statistical significance is defined as a p-value ≤0.05.|Paired t-test|||Change from Baseline at Week 12 (Normal Skin)||||0.3
72464850|NCT03302559|144452079|OTHER|Testing hypothesis is that the mean change from baseline is zero.||||||0.4||||||Statistical significance is defined as a p-value ≤0.05.|Paired t-test|||Change from Baseline at Week 12 (Target Lesion)||||0.4
72464851|NCT00113269|144452084|SUPERIORITY_OR_OTHER||differences in event rates|-3.3||||0.4889|TWO_SIDED|95.305|-12.7|6.1|||Normal approximation|Analysis based on normal approximation using Greenwood's formula for standard error.|95.305% Confidence Interval is reported, as adjusted for interim analysis based on normal approximation using Greenwood's formula for standard error.|||6.1|-12.7|0.4889
72464852|NCT00113269|144452084|SUPERIORITY_OR_OTHER||differences in event rates|-15.7|||<|0.0001|TWO_SIDED|95.305|-21.9|-9.4|||normal approximation|Analysis based on normal approximation using Greenwood's formula for standard error.|95.305% Confidence Interval is reported, as adjusted for interim analysis based on normal approximation using Greenwood's formula for standard error.|||-9.4|-21.9|<0.0001
72464853|NCT00113269|144452085|SUPERIORITY_OR_OTHER||differences in event rates|2.7||||0.6533|TWO_SIDED|95.0|-9.0|14.3|||normal approximation|||||14.3|-9.0|0.6533
72464854|NCT00113269|144452085|SUPERIORITY_OR_OTHER||differences in event rates|-11.9||||0.0024|TWO_SIDED|95.0|-19.5|-4.2|||normal approximation|||||-4.2|-19.5|0.0024
72464855|NCT00113269|144452086|SUPERIORITY_OR_OTHER||differences in event rates|-6.1||||0.4087|TWO_SIDED|95.0|-20.7|8.4|||normal approximation|||||8.4|-20.7|0.4087
72464856|NCT00113269|144452086|SUPERIORITY_OR_OTHER||differences in event rates|-8.7||||0.0456|TWO_SIDED|95.0|-17.2|-0.2|||normal approximation|||||-0.2|-17.2|0.0456
72464857|NCT00113269|144452087|SUPERIORITY_OR_OTHER||differences in event rates|1.1||||0.8742|TWO_SIDED|95.0|-12.7|15.0|||normal approximation|||||15.0|-12.7|0.8742
72464858|NCT00113269|144452087|SUPERIORITY_OR_OTHER||differences in event rates|-14.1||||0.001|TWO_SIDED|95.0|-22.5|-5.7|||normal approximation|||||-5.7|-22.5|0.0010
72464859|NCT00113269|144452089|SUPERIORITY_OR_OTHER||differences in event rates|3.5||||0.4134|TWO_SIDED|95.0|-4.8|11.7|||normal approximation|Analysis based on normal approximation using Greenwood's formula for standard error.||||11.7|-4.8|0.4134
72464860|NCT00113269|144452089|SUPERIORITY_OR_OTHER||differences in event rates|2.4||||0.2459|TWO_SIDED|95.0|-1.7|6.5|||normal approximation|Analysis based on normal approximation using Greenwood's formula for standard error.||||6.5|-1.7|0.2459
72464861|NCT00113269|144452090|SUPERIORITY_OR_OTHER||differences in event rates|6.0||||0.3155|TWO_SIDED|95.0|-5.7|17.6|||normal approximation|||||17.6|-5.7|0.3155
72464862|NCT00113269|144452090|SUPERIORITY_OR_OTHER||differences in event rates|-0.4||||0.9045|TWO_SIDED|95.0|-6.5|5.7|||normal approximation|||||5.7|-6.5|0.9045
72464863|NCT00113269|144452091|SUPERIORITY_OR_OTHER||differences in event rates|1.6||||0.5265|TWO_SIDED|95.0|-3.4|6.7|||normal approximation|Analysis based on normal approximation using Greenwood's formula for standard error.||||6.7|-3.4|0.5265
72464864|NCT00113269|144452091|SUPERIORITY_OR_OTHER||differences in event rates|-0.6||||0.682|TWO_SIDED|95.0|-3.4|2.2|||normal approximation|Analysis based on normal approximation using Greenwood's formula for standard error.||||2.2|-3.4|0.6820
72464865|NCT00113269|144452092|SUPERIORITY_OR_OTHER||differences in event rates|5.9||||0.1797|TWO_SIDED|95.0|-2.7|14.4|||normal approximation|||||14.4|-2.7|0.1797
72464866|NCT00113269|144452092|SUPERIORITY_OR_OTHER||differences in event rates|-1.4||||0.5655|TWO_SIDED|95.0|-6.3|3.4|||normal approximation|||||3.4|-6.3|0.5655
72464867|NCT00113269|144452093|SUPERIORITY_OR_OTHER|||||||0.4735||95.0|||||ANCOVA|Analysis tests the difference between treatment groups for the mean change from month 1 with the month 1 value as covariate.||P-Value applies to 'Change from Month 1'||||0.4735
72464868|NCT00113269|144452093|SUPERIORITY_OR_OTHER|||||||0.1186||95.0|||||ANCOVA|Analysis tests the difference between treatment groups for the mean change from month 1 with the month 1 value as covariate.||P-Value applies to 'Change from Month 1'||||0.1186
72464869|NCT00113269|144452094|SUPERIORITY_OR_OTHER|||||||0.5231||95.0|||||ANCOVA|Analysis tests the difference between treatment groups for the mean change from month 1 with the month 1 value as covariate.||P-Value applies to 'Change from Month 1'||||0.5231
72464870|NCT00113269|144452094|SUPERIORITY_OR_OTHER|||||||0.122||95.0|||||ANCOVA|Analysis tests the difference between treatment groups for the mean change from month 1 with the month 1 value as covariate.||P-Value applies to 'Change from Month 1'||||0.1220
72464871|NCT03511378|144452134|NON_INFERIORITY|Non-inferiority was assessed using a margin of -0.10|Difference in proportions|-0.0296||||0.007|ONE_SIDED|95.0|-0.076||||Difference in proportion|Binomial proportion used to present difference in proportion in treatments||Analysis population : ITT|||-0.076|0.007
72464872|NCT03511378|144452135|NON_INFERIORITY|Noninferiority is assessed using a margin of 10 percentage points.|Difference in proportions|0.0145|||<|0.001|ONE_SIDED|95.0|-0.0092||||Difference in proportion||Difference of proportion analysed with one sided 95% confidence interval|Analysis population: ITT|||-0.0092|<0.001
72464873|NCT00510198|144452147|SUPERIORITY_OR_OTHER|||||||0.23|TWO_SIDED|95.0||||The log-rank test was conducted at an alpha level of 0.05. The study was terminated early due to enrollment significantly below protocol expectation. Due to the low sample size and consequently low statistical power, no conclusion can be drawn.|Log Rank|||This is a log-rank test, which uses the time from randomization to first composite endpoint event to compare the risk of event between Access and Control arms.||||0.23
72464874|NCT00510198|144452148|NON_INFERIORITY_OR_EQUIVALENCE|Pre-specified non-inferiority margin was 7.5%|Risk Difference (RD)|4.7||||0.36|TWO_SIDED|95.0|-10.9|20.3||The study was terminated early due to enrollment significantly below protocol expectation. Due to the low sample size and consequently low statistical power, no conclusion can be drawn.|Two-sample test of proportions||The risk difference estimate is the difference between the Access Arm and Control arm.|||20.3|-10.9|0.36
72464875|NCT00637247|144452151|SUPERIORITY_OR_OTHER|||||||0.2|||||||Log Rank|||The hypothesis that survival curves were equal in the two treatment groups was tested with a one-sided logrank test at the alpha-0.2 level, one sided. The power of this test is 80% for detecting the hypothesized increase in median survival of 2.4 months for subjects in the experimental arm.||||0.2
72464876|NCT02847637|144452196|SUPERIORITY||ABR Ratio|0.04|||<|0.0001|TWO_SIDED|95.0|0.02|0.075||Statistical significance is controlled at the 2-sided, 0.05 alpha level. The p-value was obtained via a global model with a 3-level categorical effect for treatment (emicizumab 1.5 mg/kg/week, emicizumab 3 mg/kg/2 weeks, or no prophylaxis).|Stratified Wald test||Arm A is the numerator and Arm C is the denominator for this ABR Ratio.|H0 (null hypothesis): ABR Ratio for Arm A versus Arm C = 1. H1 (alternative hypothesis): ABR Ratio for Arm A versus Arm C ≠ 1.||0.075|0.020|<0.0001
72464877|NCT02847637|144452196|SUPERIORITY||ABR Ratio|0.03|||<|0.0001|TWO_SIDED|95.0|0.017|0.066||Statistical significance is controlled at the 2-sided, 0.05 alpha level. The p-value was obtained via a global model with a 3-level categorical effect for treatment (emicizumab 1.5 mg/kg/week, emicizumab 3 mg/kg/2 weeks, or no prophylaxis).|Stratified Wald test||Arm B is the numerator and Arm C is the denominator for this ABR Ratio.|H0 (null hypothesis): ABR Ratio for Arm B versus Arm C = 1. H1 (alternative hypothesis): ABR Ratio for Arm B versus Arm C ≠ 1.||0.066|0.017|<0.0001
72464878|NCT02847637|144452197|SUPERIORITY||ABR Ratio|0.05|||<|0.0001|TWO_SIDED|95.0|0.028|0.099||Statistical significance is controlled at the 2-sided, 0.05 alpha level. The p-value was obtained via a global model with a 3-level categorical effect for treatment (emicizumab 1.5 mg/kg/week, emicizumab 3 mg/kg/2 weeks, or no prophylaxis).|Stratified Wald test||Arm A is the numerator and Arm C is the denominator for this ABR Ratio.|H0 (null hypothesis): ABR Ratio for Arm A versus Arm C = 1. H1 (alternative hypothesis): ABR Ratio for Arm A versus Arm C ≠ 1.||0.099|0.028|<0.0001
72564036|NCT01115855|144659700|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.81|||||TWO_SIDED|95.0|0.49|1.33||||||Cox Proportional Hazard Model with baseline NYHA cohort (II, III/IV) and baseline eGFR (30--\<50 ml/min/1.73 m\^2, \>=-50 ml/min/1.73 m\^2) covariates.||1.33|0.49|
72464879|NCT02847637|144452197|SUPERIORITY||ABR Ratio|0.06|||<|0.0001|TWO_SIDED|95.0|0.03|0.103||Statistical significance is controlled at the 2-sided, 0.05 alpha level. The p-value was obtained via a global model with a 3-level categorical effect for treatment (emicizumab 1.5 mg/kg/week, emicizumab 3 mg/kg/2 weeks, or no prophylaxis).|Stratified Wald test||Arm B is the numerator and Arm C is the denominator for this ABR Ratio.|H0 (null hypothesis): ABR Ratio for Arm B versus Arm C = 1. H1 (alternative hypothesis): ABR Ratio for Arm B versus Arm C ≠ 1.||0.103|0.030|<0.0001
72464880|NCT02847637|144452198|SUPERIORITY||ABR Ratio|0.04|||<|0.0001|TWO_SIDED|95.0|0.019|0.085||Statistical significance is controlled at the 2-sided, 0.05 alpha level. The p-value is obtained via a global model with a 3-level categorical effect for treatment (emicizumab 1.5 mg/kg/week, emicizumab 3 mg/kg/2 weeks, or no prophylaxis).|Stratified Wald test||Arm A is the numerator and Arm C is the denominator for this ABR Ratio.|H0 (null hypothesis): ABR Ratio for Arm A versus Arm C = 1. H1 (alternative hypothesis): ABR Ratio for Arm A versus Arm C ≠ 1.||0.085|0.019|<0.0001
72464881|NCT02847637|144452198|SUPERIORITY||ABR Ratio|0.03|||<|0.0001|TWO_SIDED|95.0|0.015|0.07||Statistical significance is controlled at the 2-sided, 0.05 alpha level. The p-value is obtained via a global model with a 3-level categorical effect for treatment (emicizumab 1.5 mg/kg/week, emicizumab 3 mg/kg/2 weeks, or no prophylaxis).|Stratified Wald test||Arm B is the numerator and Arm C is the denominator for this ABR Ratio.|H0 (null hypothesis): ABR Ratio for Arm B versus Arm C = 1. H1 (alternative hypothesis): ABR Ratio for Arm B versus Arm C ≠ 1.||0.070|0.015|<0.0001
72464882|NCT02847637|144452199|SUPERIORITY||ABR Ratio|0.06|||<|0.0001|TWO_SIDED|95.0|0.025|0.151||Statistical significance is controlled at the 2-sided, 0.05 alpha level. The p-value is obtained via a global model with a 3-level categorical effect for treatment (emicizumab 1.5 mg/kg/week, emicizumab 3 mg/kg/2 weeks, or no prophylaxis).|Stratified Wald test||Arm A is the numerator and Arm C is the denominator for this ABR Ratio.|H0 (null hypothesis): ABR Ratio for Arm A versus Arm C = 1. H1 (alternative hypothesis): ABR Ratio for Arm A versus Arm C ≠ 1.||0.151|0.025|<0.0001
72464883|NCT02847637|144452199|SUPERIORITY||ABR Ratio|0.02|||<|0.0001|TWO_SIDED|95.0|0.006|0.056||Statistical significance is controlled at the 2-sided, 0.05 alpha level. The p-value is obtained via a global model with a 3-level categorical effect for treatment (emicizumab 1.5 mg/kg/week, emicizumab 3 mg/kg/2 weeks, or no prophylaxis).|Stratified Wald test||Arm B is the numerator and Arm C is the denominator for this ABR Ratio.|H0 (null hypothesis): ABR Ratio for Arm B versus Arm C = 1. H1 (alternative hypothesis): ABR Ratio for Arm B versus Arm C ≠ 1.||0.056|0.006|<0.0001
72464884|NCT02847637|144452200|SUPERIORITY||ABR Ratio|0.05|||<|0.0001|TWO_SIDED|95.0|0.016|0.143||Not controlled for type I error|Stratified Wald test||Arm A is the numerator and Arm C is the denominator for this ABR Ratio.|H0 (null hypothesis): ABR Ratio for Arm A versus Arm C = 1. H1 (alternative hypothesis): ABR Ratio for Arm A versus Arm C ≠ 1.||0.143|0.016|<0.0001
72464885|NCT02847637|144452200|SUPERIORITY||ABR Ratio|0.05|||<|0.0001|TWO_SIDED|95.0|0.018|0.147||Not controlled for type I error|Stratified Wald test||Arm B is the numerator and Arm C is the denominator for this ABR Ratio.|H0 (null hypothesis): ABR Ratio for Arm B versus Arm C = 1. H1 (alternative hypothesis): ABR Ratio for Arm B versus Arm C ≠ 1.||0.147|0.018|<0.0001
72464886|NCT02847637|144452201|SUPERIORITY||ABR Ratio|0.32|||<|0.0001|TWO_SIDED|95.0|0.195|0.514||Statistical significance is controlled at the 2-sided, 0.05 alpha level.|Non-stratified Wald test||Dnisp: Emicizumab Prophylaxis is the numerator and Dnisp: Pre-Study FVIII Prophylaxis is the denominator for this ABR ratio.|H0 (null hypothesis): ABR Ratio = 1. H1 (alternative hypothesis): ABR Ratio ≠ 1.||0.514|0.195|<0.0001
72464887|NCT02847637|144452202|SUPERIORITY||ABR Ratio|0.37||||0.0002|TWO_SIDED|95.0|0.22|0.626||Statistical significance is controlled at the 2-sided, 0.05 alpha level.|Non-stratified Wald test||Dnisp: Emicizumab Prophylaxis is the numerator and Dnisp: Pre-Study FVIII Prophylaxis is the denominator for this ABR ratio.|H0 (null hypothesis): ABR Ratio = 1. H1 (alternative hypothesis): ABR Ratio ≠ 1.||0.626|0.220|0.0002
72464888|NCT02847637|144452203|SUPERIORITY||ABR Ratio|0.03|||<|0.0001|TWO_SIDED|95.0|0.014|0.067||Not controlled for type I error|Non-stratified Wald test||Arm A+Bnise: Emicizumab Prophylaxis is the numerator and Arm A+Bnise: Pre-Study Episodic FVIII is the denominator for this ABR Ratio.|H0 (null hypothesis): ABR Ratio = 1. H1 (alternative hypothesis): ABR Ratio ≠ 1.||0.067|0.014|<0.0001
72464889|NCT02847637|144452204|SUPERIORITY||ABR Ratio|0.04|||<|0.0001|TWO_SIDED|95.0|0.023|0.068||Not controlled for type I error|Non-stratified Wald test||Arm A+Bnise: Emicizumab Prophylaxis is the numerator and Arm A+Bnise: Pre-Study Episodic FVIII is the denominator for this ABR Ratio.|H0 (null hypothesis): ABR Ratio = 1. H1 (alternative hypothesis): ABR Ratio ≠ 1.||0.068|0.023|<0.0001
72464890|NCT02847637|144452205|SUPERIORITY||Mean Difference (Final Values)|12.51||||0.0891|TWO_SIDED|95.0|-1.96|26.98||Statistical significance is controlled at the 2-sided, 0.05 alpha level.|ANCOVA||The difference in adjusted means was analyzed as Arm C minus Arm A.|||26.98|-1.96|0.0891
72464891|NCT02847637|144452205|SUPERIORITY||Mean Difference (Final Values)|15.97||||0.0349|TWO_SIDED|95.0|1.16|30.78||Not controlled for type I error|ANCOVA||The difference in adjusted means was analyzed as Arm C minus Arm B.|||30.78|1.16|0.0349
72464892|NCT02847637|144452206|SUPERIORITY||Mean Difference (Final Values)|5.91||||0.1269|TWO_SIDED|95.0|-1.72|13.55||Not controlled for type I error|ANCOVA||The difference in adjusted means was analyzed as Arm C minus Arm A.|||13.55|-1.72|0.1269
72464893|NCT02847637|144452206|SUPERIORITY||Mean Difference (Final Values)|8.56||||0.0317|TWO_SIDED|95.0|0.77|16.35||Not controlled for type I error|ANCOVA||The difference in adjusted means was analyzed as Arm C minus Arm B.|||16.35|0.77|0.0317
72464894|NCT02847637|144452207|SUPERIORITY||Mean Difference (Final Values)|-4.04||||0.3402|TWO_SIDED|95.0|-12.43|4.35||Not controlled for type I error|ANCOVA||The difference in adjusted means was analyzed as Arm C minus Arm A.|||4.35|-12.43|0.3402
72464895|NCT02847637|144452207|SUPERIORITY||Mean Difference (Final Values)|-9.15||||0.0373|TWO_SIDED|95.0|-17.74|-0.55||Not controlled for type I error|ANCOVA||The difference in adjusted means was analyzed as Arm C minus Arm B.|||-0.55|-17.74|0.0373
72464896|NCT02847637|144452208|SUPERIORITY||Mean Difference (Final Values)|-0.13||||0.006|TWO_SIDED|95.0|-0.22|-0.04||Not controlled for type I error|ANCOVA||The difference in adjusted means was analyzed as Arm C minus Arm A.|||-0.04|-0.22|0.0060
72464897|NCT02847637|144452208|SUPERIORITY||Mean Difference (Final Values)|-0.13||||0.0059|TWO_SIDED|95.0|-0.23|-0.04||Not controlled for type I error|ANCOVA||The difference in adjusted means was analyzed as Arm C minus Arm B.|||-0.04|-0.23|0.0059
72464898|NCT00413634|144452253|SUPERIORITY_OR_OTHER_LEGACY|||||||0.092||95.0|||||ANOVA|||||||0.092
72464899|NCT00413634|144452256|SUPERIORITY_OR_OTHER_LEGACY|||||||0.857||95.0|||||ANOVA|||||||0.857
72502467|NCT01740362|144535488|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric mean|104.17|||||TWO_SIDED|90.0|75.18|144.34||||||One way ANOVA on natural log-transformed Cmax were analyzed using linear model containing degrees of renal impairment (CLcr, discrete) calculated using blood samples collected at screening as fixed effects. SAS procedure PROC MIXED was used for analysis. Anti-log of the adjusted mean difference (CP-690,550 \[moderate renal insufficiency\] - CP-690,550 \[normal renal function\]) and its corresponding 90% CI were taken to estimate the mean ratio and corresponding 90% CI.||144.34|75.18|
72464900|NCT00413634|144452257|SUPERIORITY_OR_OTHER_LEGACY|||||||0.013||95.0|||||ANOVA|||||||0.013
72464901|NCT00413634|144452258|SUPERIORITY_OR_OTHER_LEGACY|||||||0.378||95.0|||||ANOVA|||||||0.378
72464902|NCT00413634|144452259|SUPERIORITY_OR_OTHER_LEGACY|||||||0.013||95.0|||||ANOVA|||||||0.013
72464903|NCT00413634|144452260|SUPERIORITY_OR_OTHER_LEGACY|||||||0.035||95.0|||||ANOVA|||||||0.035
72464904|NCT00413634|144452261|SUPERIORITY_OR_OTHER_LEGACY|||||||0.023||95.0|||||ANOVA|||||||0.023
72464905|NCT00413634|144452262|SUPERIORITY_OR_OTHER_LEGACY|||||||0.557||95.0|||||ANOVA|||||||0.557
72464906|NCT00413634|144452263|SUPERIORITY_OR_OTHER_LEGACY|||||||0.027||95.0|||||ANOVA|||||||0.027
72464907|NCT00413634|144452264|SUPERIORITY_OR_OTHER_LEGACY|||||||0.007||95.0|||||ANOVA|||||||0.007
72502468|NCT01740362|144535488|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric mean|117.65|||||TWO_SIDED|95.0|84.91|163.02||||||One way ANOVA on natural log-transformed Cmax were analyzed using linear model containing degrees of renal impairment (CLcr, discrete) calculated using blood samples collected at screening as fixed effects. SAS procedure PROC MIXED was used for analysis. Anti-log of the adjusted mean difference (CP-690,550 \[severe renal insufficiency\] - CP-690,550 \[normal renal function\]) and its corresponding 90% CI were taken to estimate the mean ratio and corresponding 90% CI.||163.02|84.91|
72502469|NCT02698189|144535563|OTHER|80% Bayesian credible interval based on a prior distribution of Beta (1, 1).|||||||||||||||||80% 2-sided Bayesian credible interval: lower = 0.000; upper = 0.415|||
72502470|NCT02698189|144535563|OTHER|80% Bayesian credible interval based on a prior distribution of Beta (1, 1).|||||||||||||||||80% 2-sided Bayesian credible interval: lower = 0.040; upper = 0.391|||
72502471|NCT03119649|144535585|SUPERIORITY||Difference in LS Means|-3.3|STANDARD_ERROR_OF_MEAN|4.15||0.4291|TWO_SIDED|95.0|-11.6|5.0||P-value obtained from the Mixed Effects Model for Repeated Measures (MMRM) analysis with treatment as factor and baseline as covariate. Pairwise comparisons were not corrected for multiplicity.|ANCOVA|||Day 29: GLPG2222 50 mg QD vs. Pooled Placebo||5.0|-11.6|0.4291
72564037|NCT01115855|144659701|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.7|||||TWO_SIDED|95.0|0.45|1.1||||||Cox Proportional Hazard Model with baseline NYHA cohort (II, III/IV) and baseline eGFR (30--\<50 ml/min/1.73 m\^2, \>-=50 ml/min/1.73 m\^2) covariates.||1.10|0.45|
72564038|NCT01115855|144659702|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.83|||||TWO_SIDED|95.0|0.53|1.28||||||Cox Proportional Hazard Model with baseline NYHA cohort (II, III/IV) and baseline eGFR (30--\<50 ml/min/1.73 m\^2, \>-=50 ml/min/1.73 m\^2) covariates.||1.28|0.53|
72564039|NCT01115855|144659703|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.79|||||TWO_SIDED|95.0|0.18|3.53||||||Cox Proportional Hazard Model with baseline NYHA cohort (II, III/IV) and baseline eGFR (30--\<50 ml/min/1.73 m\^2, \>-=50 ml/min/1.73 m\^2) covariates.||3.53|0.18|
72564040|NCT01115855|144659704|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.11|||||TWO_SIDED|95.0|0.07|17.85||||||Cox Proportional Hazard Model with baseline NYHA cohort (II, III/IV) and baseline eGFR (30--\<50 ml/min/1.73 m\^2, \>-=50 ml/min/1.73 m\^2) covariates.||17.85|0.07|
72564041|NCT01115855|144659705|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|2.11|||||TWO_SIDED|95.0|0.39|11.56||||||Cox Proportional Hazard Model with baseline NYHA cohort (II, III/IV) and baseline eGFR (30--\<50 ml/min/1.73 m\^2, \>-=50 ml/min/1.73 m\^2) covariates.||11.56|0.39|
72564042|NCT01115855|144659706|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.51|||||TWO_SIDED|95.0|0.05|5.66||||||Cox Proportional Hazard Model with baseline NYHA cohort (II, III/IV) and baseline eGFR (30--\<50 ml/min/1.73 m\^2, \>-=50 ml/min/1.73 m\^2) covariates.||5.66|0.05|
72464908|NCT00413634|144452265|SUPERIORITY_OR_OTHER_LEGACY|||||||0.027||95.0|||||ANOVA|||||||0.027
72464909|NCT00413634|144452266|SUPERIORITY_OR_OTHER_LEGACY|||||||0.011||95.0|||||ANOVA|||||||0.011
72464910|NCT01187407|144452300|SUPERIORITY_OR_OTHER|||||||0.997||||||Primary comparison.|Mixed Models Analysis|||||||0.997
72464911|NCT01187407|144452300|SUPERIORITY_OR_OTHER|||||||0.769||||||Secondary comparison.|Mixed Models Analysis|||||||0.769
72464912|NCT02101268|144452332|SUPERIORITY||Proportion Difference - Stratified CMH|0.01||||0.9|TWO_SIDED|95.0|-0.09|0.1|||Cochran-Mantel-Haenszel|||||0.10|-0.09|0.90
72464913|NCT02101268|144452333|SUPERIORITY||Proportion Difference - Stratified CMH|0.2|||<|0.001|TWO_SIDED|95.0|0.09|0.32|||Cochran-Mantel-Haenszel|||||0.32|0.09|< 0.001
72464914|NCT02101268|144452334|SUPERIORITY||Rate ratio|0.8||||0.38|TWO_SIDED|95.0|0.49|1.31|||Negative Binomial Model, Adjusted||A smaller ratio represents larger benefit.|||1.31|0.49|0.38
72464915|NCT02101268|144452335|SUPERIORITY||Proportion Difference - Stratified CMH|0.23||||0.001|TWO_SIDED|95.0|0.09|0.37|||Cochran-Mantel-Haenszel||A larger proportion represents larger benefit.|||0.37|0.09|0.001
72464916|NCT02101268|144452336|SUPERIORITY||Proportion Difference - Stratified CMH|-0.13||||0.1|TWO_SIDED|95.0|-0.29|0.03|||Cochran-Mantel-Haenszel||A smaller proportion represents larger benefit.|||0.03|-0.29|0.10
72564043|NCT01115855|144659707|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.13|||||TWO_SIDED|95.0|0.16|8.04||||||Cox Proportional Hazard Model with baseline NYHA cohort (II, III/IV) and baseline eGFR (30--\<50 ml/min/1.73 m\^2, \>-=50 ml/min/1.73 m\^2) covariates.||8.04|0.16|
72564044|NCT01115855|144659709|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-102.93|STANDARD_ERROR_OF_MEAN|47.13|||TWO_SIDED|95.0|-195.92|-9.94||||||Change from baseline at Month 5 : Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||-9.94|-195.92|
72564045|NCT01115855|144659709|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-95.77|STANDARD_ERROR_OF_MEAN|44.54|||TWO_SIDED|95.0|-184.51|-7.04||||||Change from baseline at Month 9 :Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||-7.04|-184.51|
72564046|NCT01115855|144659709|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-125.09|STANDARD_ERROR_OF_MEAN|35.15|||TWO_SIDED|95.0|-195.5|-54.68||||||Change from baseline at Month 13 : Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||-54.68|-195.50|
72564047|NCT01115855|144659709|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-31.94|STANDARD_ERROR_OF_MEAN|51.12|||TWO_SIDED|95.0|-232.77|-31.11||||||Change from baseline at Month 17 :Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||-31.11|-232.77|
72564048|NCT01115855|144659709|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-132.39|STANDARD_ERROR_OF_MEAN|52.77|||TWO_SIDED|95.0|-240.94|-23.84||||||Change from baseline at Month 21 : Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||-23.84|-240.94|
72564049|NCT01115855|144659709|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-117.18|STANDARD_ERROR_OF_MEAN|51.76|||TWO_SIDED|95.0|-221.49|-12.87||||||Change from baseline at Month 25 :Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||-12.87|-221.49|
72564050|NCT01115855|144659709|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-101.5|STANDARD_ERROR_OF_MEAN|61.05|||TWO_SIDED|95.0|-267.36|64.36||||||Change from baseline at Month 29 :Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||64.36|-267.36|
72564051|NCT01115855|144659709|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-110.78|STANDARD_ERROR_OF_MEAN|92.42|||TWO_SIDED|95.0|-307.49|85.93||||||Change from baseline at Month 33 : Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||85.93|-307.49|
72464917|NCT00740870|144452337|SUPERIORITY||Kaplan-Meier Rate|74.2|||<|0.0001|ONE_SIDED|95.0|67.1||||Z test||||||67.1|<0.0001
72464918|NCT02831998|144452353|NON_INFERIORITY|Investigational product upper bounds must be less than 0.5.|Median Difference (Final Values)|0.0|||||TWO_SIDED|95.0|-0.188|0.083||||||Groin 10 minutes Average Treatment Effect, calculated using a linear regression model for each body site, was used for primary analysis. In the model, the response was the post-treatment log10 CFU/cm\^2 bacterial counts and the predictors were the treatment effect as a fixed effect and the pre-treatment log10 CFU/cm\^2 bacterial counts as a covariate.||0.083|-0.188|
72464919|NCT02831998|144452353|SUPERIORITY|Investigational product lower bounds must be greater than 1.2.|Median Difference (Final Values)|2.627|||||TWO_SIDED|95.0|2.396|2.858||||||Groin 10 minutes Average Treatment Effect, calculated using a linear regression model for each body site, was used for primary analysis. In the model, the response was the post-treatment log10 CFU/cm\^2 bacterial counts and predictors were the treatment effect as a fixed effect and the pre-treatment log10 CFU/cm\^2 bacterial counts as a covariate.||2.858|2.396|
72464920|NCT02831998|144452354|NON_INFERIORITY|Investigational product average treatment effect upper bounds cannot be more than 0.5.|Mean Difference (Final Values)|-0.018|||||TWO_SIDED|95.0|-0.102|0.065||||||Abdomen 10 minutes Average Treatment Effect, calculated using a linear regression model for each body site, was used for primary analysis. In the model, the response was the post-treatment log10 CFU/cm\^2 bacterial counts and predictors were the treatment effect as a fixed effect and the pre-treatment log10 CFU/cm\^2 bacterial counts as a covariate.||0.065|-0.102|
72464921|NCT02831998|144452354|SUPERIORITY|Investigational product lower bounds must be greater than 1.2.|Mean Difference (Final Values)|1.909|||||TWO_SIDED|95.0|1.766|2.053||||||Abdomen 10 minutes Average Treatment Effect, calculated using a linear regression model for each body site, was used for primary analysis. In the model, the response was the post-treatment log10 CFU/cm\^2 bacterial counts and predictors were the treatment effect as a fixed effect and the pre-treatment log10 CFU/cm\^2 bacterial counts as a covariate.||2.053|1.766|
72464922|NCT05324007|144452355|EQUIVALENCE|Estimated effect size was based on Liberman et al. (2017) that found a partial eta squared of .478 for the interaction between different-language and same-language conditions. Using G\*power using an alpha of .05, our target sample size of 30 per condition should provide 99.73% power to detect the main effect in the White-White and Black-Black condition and 99.99% power to detect the main effect in the Black-White condition.|partial eta squared|0.062|||<|0.05|TWO_SIDED||||||ANOVA|||We will examine whether looking time at affiliation will be greater when looking at Black-White interactions than at White-White or Black-Black interactions. That is, we will test if infants will be more surprised (look longer) by affiliation between different-race people interacting than same race people interacting. We will conduct a mixed ANOVA with conditions (Black-White, White-White, Black-Black) as a between-subject and test type (affiliation vs. disengagement) as within-subject factors.||||<.05
72464923|NCT00839332|144452357|SUPERIORITY_OR_OTHER||Bayesian Posterior Probability|0.333|||||TWO_SIDED||||||||Inference about survival was made using a Bayesian posterior probability. The combination treatment would have been considered superior to gemcitabine alone if the posterior probability of superiority exceeded 0.8.|||||
72464924|NCT00776984|144452384|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.154|STANDARD_ERROR_OF_MEAN|0.032|<|0.0001||95.0|0.091|0.217||Step-wise testing for co-primary endpoints, confirmatory only if previous hypotheses had been successful, significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment\*visit and baseline\*visit.|||0.217|0.091|<0.0001
72464925|NCT00776984|144452385|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.111|STANDARD_ERROR_OF_MEAN|0.03||0.0002||95.0|0.053|0.169||Step-wise testing for co-primary endpoints, confirmatory only if previous hypotheses had been successful, significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment\*visit and baseline\*visit.|||0.169|0.053|0.0002
72464926|NCT00776984|144452386|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.79||||0.0343||||||Confirmatory only if previous hypotheses for each of the 2 twin studies had been successful, significance level of alpha=0.05 (2-sided). A pre-specified interim analysis was performed. Cui et al (Biometrics,1999) was used to calculate the p-value.|Regression, Cox|Parameter estimates of Cox proportional hazard model regression regarding. Only treatment was fitted as an effect in the model.|If HR is below 1 then favours tiotropium.|||||0.0343
72464927|NCT00776984|144452387|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.094|STANDARD_ERROR_OF_MEAN|0.042||0.0275||95.0|0.01|0.177||Significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment\*visit and baseline\*visit.|||0.177|0.010|0.0275
72464928|NCT00776984|144452388|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.106|STANDARD_ERROR_OF_MEAN|0.041||0.0099||95.0|0.025|0.186||Significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment\*visit and baseline\*visit.|||0.186|0.025|0.0099
72464929|NCT00776984|144452389|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.143|STANDARD_ERROR_OF_MEAN|0.03|<|0.0001||95.0|0.084|0.202||Significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment\*visit and baseline\*visit.|||0.202|0.084|<0.0001
72464930|NCT00776984|144452390|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.109|STANDARD_ERROR_OF_MEAN|0.04||0.0063||95.0|0.031|0.187||Significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment\*visit and baseline\*visit.|||0.187|0.031|0.0063
72464931|NCT00776984|144452391|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.152|STANDARD_ERROR_OF_MEAN|0.033|<|0.0001||95.0|0.087|0.217||Significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment\*visit and baseline\*visit.|||0.217|0.087|<0.0001
72464932|NCT00776984|144452392|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.092|STANDARD_ERROR_OF_MEAN|0.03||0.0026||95.0|0.032|0.151||Significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment\*visit and baseline\*visit.|||0.151|0.032|0.0026
72464933|NCT00776984|144452393|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.138|STANDARD_ERROR_OF_MEAN|0.031|<|0.0001||95.0|0.078|0.199||Significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment\*visit and baseline\*visit.|||0.199|0.078|<0.0001
72464934|NCT00776984|144452394|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.114|STANDARD_ERROR_OF_MEAN|0.044||0.0088||95.0|0.029|0.2||Significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment\*visit and baseline\*visit.|||0.200|0.029|0.0088
72464935|NCT00776984|144452395|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.071|STANDARD_ERROR_OF_MEAN|0.042||0.0933||95.0|-0.012|0.153||Significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment\*visit and baseline\*visit.|||0.153|-0.012|0.0933
72464936|NCT00776984|144452396|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.109|STANDARD_ERROR_OF_MEAN|0.041||0.0074||95.0|0.029|0.189||Significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment\*visit and baseline\*visit.|||0.189|0.029|0.0074
72464937|NCT00776984|144452397|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|20.654|STANDARD_ERROR_OF_MEAN|4.807|<|0.0001||95.0|11.199|30.108||Significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment\*visit and baseline\*visit.|||30.108|11.199|<0.0001
72464938|NCT00776984|144452398|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|32.453|STANDARD_ERROR_OF_MEAN|5.044|<|0.0001||95.0|22.532|42.374||Significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment\*visit and baseline\*visit.|||42.374|22.532|<0.0001
72464939|NCT00776984|144452399|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.09|STANDARD_ERROR_OF_MEAN|0.03||0.0027||95.0|0.031|0.149||Significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment\*visit and baseline\*visit.|||0.149|0.031|0.0027
72464940|NCT00776984|144452400|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.137|STANDARD_ERROR_OF_MEAN|0.032|<|0.0001||95.0|0.074|0.2||Significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment\*visit and baseline\*visit.|||0.200|0.074|<0.0001
72464941|NCT00776984|144452401|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.197|STANDARD_ERROR_OF_MEAN|0.741||0.1073||95.0|-0.261|2.655||Significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment\*visit and baseline\*visit.|||2.655|-0.261|0.1073
72564052|NCT01115855|144659709|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-119.62|STANDARD_ERROR_OF_MEAN|158.84|||TWO_SIDED|95.0|-2137.82|1898.59||||||Change from baseline at Month 37 : Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||1898.59|-2137.82|
72464942|NCT00776984|144452402|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.89||||0.4788||95.0|0.65|1.23||Significance level of alpha=0.05 (two-sided).|Regression, Cox|Parameter estimates of Cox proportional hazard model regarding. Only treatment was fitted as an effect in the model.|If HR is below 1 then favours tiotropium.|||1.23|0.65|0.4788
72464943|NCT00776984|144452403|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.8|STANDARD_ERROR_OF_MEAN|0.11||0.1007||95.0|0.61|1.04||Significance level of alpha=0.05 (two-sided).|Poisson Regression|Parameter estimates of Poisson regression model. Log exposure was used as offset and adjusted for overdispersion.|Tio R5 - Placebo|||1.04|0.61|0.1007
72464944|NCT00776984|144452404|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.96|STANDARD_ERROR_OF_MEAN|0.15||0.7906||95.0|0.71|1.3||Significance level of alpha=0.05 (two-sided).|Poisson Regression|Parameter estimates of Poisson regression model. Log exposure was used as offset and adjusted for overdispersion.|Tio R5 - Placebo|||1.30|0.71|0.7906
72393984|NCT01059825|144294290|SUPERIORITY_OR_OTHER||Difference in least squares means|-2.64||||0.025|TWO_SIDED|80.0|-4.37|-0.92||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-0.92|-4.37|0.025
72464945|NCT00776984|144452405|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.57||||0.004||95.0|0.38|0.84||Significance level of alpha=0.05 (two-sided).|Fisher Exact|Exact 95 percent confidence interval by Clopper and Pearson.|Tio R5 vs Placebo|||0.84|0.38|0.0040
72464946|NCT00776984|144452406|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.88||||0.5481||95.0|0.58|1.32||Significance level of alpha=0.05 (two-sided).|Fisher Exact|Exact 95 percent confidence interval by Clopper and Pearson.|Tio R5 vs Placebo|||1.32|0.58|0.5481
72464947|NCT00776984|144452407|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.84||||0.7188||95.0|0.33|2.14||Significance level of alpha=0.05 (two-sided).|Regression, Cox|Parameter estimates of Cox proportional hazard model regarding. Only treatment was fitted as an effect in the model.|If HR is below 1 then favours tiotropium.|||2.14|0.33|0.7188
72464948|NCT00776984|144452408|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.95|STANDARD_ERROR_OF_MEAN|0.23||0.8503||95.0|0.59|1.54||Significance level of alpha=0.05 (two-sided).|Poisson Regression|Parameter estimates of Poisson regression model. Log exposure was used as offset and adjusted for overdispersion.|Tio R5 - Placebo.|||1.54|0.59|0.8503
72564053|NCT01115855|144659709|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-144.6|STANDARD_ERROR_OF_MEAN|200.56|||TWO_SIDED|90.0|-2692.95|2403.76||||||Change from baseline at Month 42 : Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||2403.76|-2692.95|
72564054|NCT01115855|144659709|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-77.26|STANDARD_ERROR_OF_MEAN|966.09|||TWO_SIDED|95.0|-2131.88|1977.37||||||Change from baseline at Month 48 :Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||1977.37|-2131.88|
72464949|NCT00776984|144452409|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.85||||0.8129||95.0|0.29|2.46||Significance level of alpha=0.05 (two-sided).|Fisher Exact|Exact 95 percent confidence interval by Clopper and Pearson.|Tio R5 vs Placebo|||2.46|0.29|0.8129
72464950|NCT00776984|144452410|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.178|STANDARD_ERROR_OF_MEAN|0.078||0.0225||95.0|0.025|0.331||Significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment\*visit and baseline\*visit.|||0.331|0.025|0.0225
72464951|NCT00776984|144452411|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.14|STANDARD_ERROR_OF_MEAN|0.08||0.0803||95.0|-0.017|0.296||Significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment\*visit and baseline\*visit.|||0.296|-0.017|0.0803
72464952|NCT00776984|144452412|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.199|STANDARD_ERROR_OF_MEAN|0.067||0.003||95.0|-0.33|-0.068||Significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment\*visit and baseline\*visit.|||-0.068|-0.330|0.0030
72464953|NCT00776984|144452413|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.133|STANDARD_ERROR_OF_MEAN|0.069||0.0533||95.0|-0.267|0.002||Significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment\*visit and baseline\*visit.|||0.002|-0.267|0.0533
72464954|NCT00776984|144452414|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.012|STANDARD_ERROR_OF_MEAN|0.028||0.6632||95.0|-0.043|0.067||Significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment\*visit and baseline\*visit.|||0.067|-0.043|0.6632
72464955|NCT00776984|144452415|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.263|STANDARD_ERROR_OF_MEAN|0.189||0.1664||95.0|-0.635|0.11||Significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment\*visit and baseline\*visit.|||0.110|-0.635|0.1664
72464956|NCT00776984|144452416|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.32||||0.0427|TWO_SIDED|95.0|1.01|1.73||Calculated as 2\*one-sided-p-value in the direction corresponding to testing the null hypothesis|Fisher Exact||Tio R5 / Placebo|Comparison at 24 weeks||1.73|1.01|0.0427
72464957|NCT00776984|144452416|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.68||||0.0001|TWO_SIDED|95.0|1.28|2.21||Calculated as 2\*one-sided-p-value in the direction corresponding to testing the null hypothesis|Fisher Exact||Tio R5 / Placebo|Comparison at 48 weeks||2.21|1.28|0.0001
72464958|NCT02573883|144452421|SUPERIORITY|||||||0.007|||||||t-test, 2 sided|||||||0.007
72464959|NCT02573883|144452422|SUPERIORITY|||||||0.014|||||||t-test, 2 sided|||||||0.014
72464960|NCT02573883|144452424|SUPERIORITY|||||||0.011|||||||Chi-squared|||||||0.011
72464961|NCT02573883|144452426|SUPERIORITY|||||||0.46|||||||t-test, 2 sided|||||||0.46
72464962|NCT00118703|144452454|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.094||||0.604|TWO_SIDED|95.0|-0.26|0.45|||ANCOVA|The analysis method was adjusted for Baseline rTNSS, country, age, and gender, in addition to treatment effect.||||0.45|-0.26|0.604
72464963|NCT00118703|144452455|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.061||||0.729|TWO_SIDED|95.0|-0.29|0.41|||ANCOVA|The analysis method was adjusted for Baseline iTNSS, country, age, and gender, in addition to treatment effect.||||0.41|-0.29|0.729
72464964|NCT00118703|144452456|SUPERIORITY_OR_OTHER|||||||0.064|||||||Regression, Logistic|Overall evaluation of response to therapy was illustrated and analyzed using logistic regression adjusting for age, gender, investigator, and treatmen||||||0.064
72464965|NCT02725008|144452477|SUPERIORITY||Odds Ratio (OR)|2.32||||0.3|TWO_SIDED|95.0|0.54|10.07|||Chi-squared|||||10.07|0.54|0.3
72502472|NCT03119649|144535585|SUPERIORITY||Difference in LS Means|-4.1|STANDARD_ERROR_OF_MEAN|4.32||0.3477|TWO_SIDED|95.0|-12.8|4.6||P-value obtained from the MMRM analysis with treatment as factor and baseline as covariate. Pairwise comparisons were not corrected for multiplicity.|ANCOVA|||Day 29: GLPG2222 100 mg QD vs. Pooled Placebo||4.6|-12.8|0.3477
72502473|NCT03119649|144535585|SUPERIORITY||Difference in LS Means|-15.8|STANDARD_ERROR_OF_MEAN|3.72|<|0.0001|TWO_SIDED|95.0|-23.2|-8.3||P-value obtained from the MMRM analysis with treatment as factor and baseline as covariate. Pairwise comparisons were not corrected for multiplicity.|ANCOVA|||Day 29: GLPG2222 200 mg QD vs. Pooled Placebo||-8.3|-23.2|<0.0001
72502474|NCT03119649|144535585|SUPERIORITY||Difference in LS Means|-6.3|STANDARD_ERROR_OF_MEAN|3.76||0.0995|TWO_SIDED|95.0|-13.9|1.2||P-value obtained from the MMRM analysis with treatment as factor and baseline as covariate. Pairwise comparisons were not corrected for multiplicity.|ANCOVA|||Day 29: GLPG2222 400 mg QD vs. Pooled Placebo||1.2|-13.9|0.0995
72502475|NCT03119649|144535586|SUPERIORITY||Difference in LS Means|1.1|STANDARD_ERROR_OF_MEAN|2.11||0.594|TWO_SIDED|95.0|-3.1|5.4||P-value obtained from the MMRM analysis with treatment as factor and baseline as covariate. Pairwise comparisons were not corrected for multiplicity.|ANCOVA|||Day 29: GLPG2222 50 mg QD vs. Pooled Placebo||5.4|-3.1|0.5940
72502476|NCT03119649|144535586|SUPERIORITY||Difference in LS Means|0.6|STANDARD_ERROR_OF_MEAN|2.06||0.7553|TWO_SIDED|95.0|-3.5|4.8||P-value obtained from the MMRM analysis with treatment as factor and baseline as covariate. Pairwise comparisons were not corrected for multiplicity.|ANCOVA|||Day 29: GLPG2222 100 mg QD vs. Pooled Placebo||4.8|-3.5|0.7553
72502477|NCT03119649|144535586|SUPERIORITY||Difference in LS Means|1.0|STANDARD_ERROR_OF_MEAN|1.94||0.5958|TWO_SIDED|95.0|-2.9|4.9||P-value obtained from the MMRM analysis with treatment as factor and baseline as covariate. Pairwise comparisons were not corrected for multiplicity.|ANCOVA|||Day 29: GLPG2222 200 mg QD vs. Pooled Placebo||4.9|-2.9|0.5958
72502478|NCT03119649|144535586|SUPERIORITY||Difference in LS Means|2.3|STANDARD_ERROR_OF_MEAN|1.94||0.2403|TWO_SIDED|95.0|-1.6|6.2||P-value obtained from the MMRM analysis with treatment as factor and baseline as covariate. Pairwise comparisons were not corrected for multiplicity.|ANCOVA|||Day 29: GLPG2222 400 mg QD vs. Pooled Placebo||6.2|-1.6|0.2403
72502479|NCT03119649|144535587|SUPERIORITY||Difference in LS Means|2.7|STANDARD_ERROR_OF_MEAN|4.81||0.5749|TWO_SIDED|95.0|-6.9|12.4||P-value obtained from the MMRM analysis with treatment as factor and baseline as covariate. Pairwise comparisons were not corrected for multiplicity.|ANCOVA|||Day 29: GLPG2222 50 mg QD vs. Pooled Placebo||12.4|-6.9|0.5749
72502480|NCT03119649|144535587|SUPERIORITY||Difference in LS Means|1.6|STANDARD_ERROR_OF_MEAN|4.83||0.7381|TWO_SIDED|95.0|-8.1|11.3||P-value obtained from the MMRM analysis with treatment as factor and baseline as covariate. Pairwise comparisons were not corrected for multiplicity.|ANCOVA|||Day 29: GLPG2222 100 mg QD vs. Pooled Placebo||11.3|-8.1|0.7381
72502481|NCT03119649|144535587|SUPERIORITY||Difference in LS Means|6.8|STANDARD_ERROR_OF_MEAN|4.43||0.1282|TWO_SIDED|95.0|-2.0|15.7||P-value obtained from the MMRM analysis with treatment as factor and baseline as covariate. Pairwise comparisons were not corrected for multiplicity.|ANCOVA|||Day 29: GLPG2222 200 mg QD vs. Pooled Placebo||15.7|-2.0|0.1282
72502482|NCT03119649|144535587|SUPERIORITY||Difference in LS Means|1.6|STANDARD_ERROR_OF_MEAN|4.43||0.7212|TWO_SIDED|95.0|-7.3|10.5||P-value obtained from the MMRM analysis with treatment as factor and baseline as covariate. Pairwise comparisons were not corrected for multiplicity.|ANCOVA|||Day 29: GLPG2222 400 mg QD vs. Pooled Placebo||10.5|-7.3|0.7212
72502483|NCT02333227|144535592|SUPERIORITY||||||<|0.05|||||||Mixed Models Analysis||||We employed generalized linear mixed methods (GLMM) with binomial distribution to examine the association between study primary outcomes of baby's birth weight (\<2500) and gestational age at delivery (\<37 weeks including up to 36 and 6/7 weeks) and assignment to the study intervention group. To account for clustering of outcomes by cluster (sites), we used random slope/random intercept GLMM models with a cluster as a random effect (level 2) and treatment as a fixed effect (level 1), since random effect modeling is an individual-level analyses that accounts for within-cluster dependence by maximum likelihood estimation. A separate model was fit to each study outcome and corresponding relative risk with 95% confidence intervals (CI) estimated. Full information maximum likelihood estimation (FIML) allows for analyses to be performed with the full sample, under conditions of Missing Completely at Random (MCAR) and Missing at Random (MAR), and with missing data rates up to 50%.|||<0.05
72502484|NCT02333227|144535593|SUPERIORITY||||||<|0.05|||||||Mixed Models Analysis|||Co-primary outcomes|We employed generalized linear mixed methods (GLMM) with binomial distribution to examine the association between study primary outcomes of baby's birth weight (\<2500) and gestational age at delivery (\<37 weeks including up to 36 and 6/7 weeks) and assignment to the study intervention group. To account for clustering of outcomes by cluster (sites), we used random slope/random intercept GLMM models with a cluster as a random effect (level 2) and treatment as a fixed effect (level 1), since random effect modeling is an individual-level analyses that accounts for within-cluster dependence by maximum likelihood estimation. A separate model was fit to each study outcome and corresponding relative risk with 95% confidence intervals (CI) estimated. Full information maximum likelihood estimation (FIML) allows for analyses to be performed with the full sample, under conditions of Missing Completely at Random (MCAR) and Missing at Random (MAR), and with missing data rates up to 50%.|||<0.05
72502485|NCT02333227|144535594|SUPERIORITY||||||<|0.05|||||||Mixed Models Analysis|||||||<0.05
72564055|NCT01115855|144659709|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-102.3|STANDARD_ERROR_OF_MEAN|35.67|||TWO_SIDED|95.0|-172.61|-32.0||||||Change from baseline at Month 13 : ANCOVA with treatment effect and covariates of the NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||-32.00|-172.61|
72464966|NCT02725008|144452478|SUPERIORITY|||||||0.95|||||||t-test, 2 sided|||||||0.95
72464967|NCT00519285|144452479|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.942||||0.3802|TWO_SIDED|95.6|0.822|1.08||A priori threshold for statistical significance was set to 0.044 using the O'Brien-Fleming alpha spending function to account for two interim analyses.|Log Rank|Log rank test stratified on ECOG Performance Status|Hazard ratio (HR) aflibercept versus placebo estimated from a Cox proportional hazard model stratified on ECOG Performance Status|"Null hypothesis: No difference between aflibercept and placebo~The study was designed to provide 90% power to detect a 1.25-fold increase in median survival with aflibercept compared to placebo at a overall one-sided significance level of 0.025 with 873 deaths."||1.08|0.822|0.3802
72464968|NCT00513461|144452492|SUPERIORITY||Mean Difference (Net)|7.78||||0.16|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.160
72464969|NCT00513461|144452505|SUPERIORITY||Mean Difference (Net)|0.43||||0.878|TWO_SIDED||||||Two-Group t-test|||||||0.878
72464970|NCT00513461|144452506|SUPERIORITY||Mean Difference (Net)|-3.66||||0.212|TWO_SIDED||||||Two-Group t-test|||||||0.212
72393985|NCT01059825|144294290|SUPERIORITY_OR_OTHER||Difference in least squares means|0.88||||0.746|TWO_SIDED|80.0|-0.82|2.58||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||2.58|-0.82|0.746
72502486|NCT02333227|144535595|SUPERIORITY||||||<|0.05|||||||Mixed Models Analysis||||Specifically, the composite of periodontal disease was also created; this composite was positive if any of the following were detected: gingival bleeding, pockets of 4 mm or greater, or loss of attachment of 4 mm or greater. A scaled periodontal disease score was also created which was the sum of scores for gingival bleeding (+1 if bleeding was present, per tooth), gingival pockets (+1 for pockets of 4-5 mm and +2 for 6 mm or deeper, per tooth), and loss of attachment (+1 for 4-5 mm loss, +2 for 6-8 mm, +3 for 9-11 mm, and +4 for 12 mm or more, per tooth with values recorded for index teeth) divided by the number of teeth present.|||<0.05
72502487|NCT02333227|144535596|SUPERIORITY||||||<|0.05|||||||Mixed Models Analysis|||||||<0.05
72502488|NCT01624194|144535600|OTHER|||||||0.0275|||||||General Linear Model (GLM)|||||||0.0275
72502489|NCT01624194|144535601|OTHER||||||>|0.05||||||Fisher's Exact Test was used to test for differences in adverse events between oxytocin-treated and placebo-treated individuals. A p-value of ≤0.05 would have been statistically significant.|Fisher Exact|||||||>0.05
72502490|NCT01624194|144535602|OTHER||||||>|0.05|||||||Mixed Models Analysis|A mixed-models analysis was used to compare between groups, and between baseline and Week 4.||||||>0.05
72502491|NCT01624194|144535605|OTHER|||||||0.3395|||||||General Linear Model (GLM)|||||||0.3395
72502492|NCT01624194|144535613|OTHER|||||||0.9757|||||||General Linear Model (GLM)|||||||0.9757
72502493|NCT01624194|144535614|OTHER||||||>|0.05|||||||Mixed Models Analysis|A mixed-models analysis was used to compare between groups, and between baseline and Week 4.||||||>0.05
72502494|NCT01624194|144535615|OTHER||||||>|0.05|||||||Mixed Models Analysis|||||||>0.05
72502495|NCT01624194|144535616|OTHER||||||>|0.05||||||For all blood pressure analyses.|Mixed Models Analysis|||||||>0.05
72464971|NCT00562484|144452550|SUPERIORITY_OR_OTHER||Vaccine Efficacy|42.0|||||TWO_SIDED|95.0|30.0|52.0||||||Vaccine efficacy = 100 x (1 - ratio of incidence rate)||52|30|
72502496|NCT03528681|144535699|OTHER||Back-transformed mean difference|0.93|||<|0.001|TWO_SIDED|95.0|0.902|0.959|||Mixed Models Analysis|||Results are derived from a longitudinal model applied to log-transformed S-K measurements adjusted for treatment, visit, treatment-by-visit interaction and baseline covariates. The back-transformation is to the original scale of the S-K measurement||0.959|0.902|<0.001
72502497|NCT03528681|144535699|OTHER||Back-transformed mean difference|0.85|||<|0.001|TWO_SIDED|95.0|0.825|0.876|||Mixed Models Analysis|||Results are derived from a longitudinal model applied to log-transformed S-K measurements adjusted for treatment, visit, treatment-by-visit interaction and baseline covariates. The back-transformation is to the original scale of the S-K measurement||0.876|0.825|<0.001
72502498|NCT03528681|144535704|OTHER|The analysis uses a generalized mixed model which includes a random intercept and logit link. The model includes all S-K data values collected at the scheduled visits between Days 8-29, dichotomized as normal and abnormal, as response variables, and baseline covariates. Placebo is the reference group.|Odds Ratio (OR)|3.8|||<|0.001|TWO_SIDED|95.0|2.17|6.67|||Mixed Models Analysis|||||6.67|2.17|<0.001
72502499|NCT03528681|144535704|OTHER||Odds Ratio (OR)|11.63|||<|0.001|TWO_SIDED|95.0|6.45|21.0|||Mixed Models Analysis|||The analysis uses a generalized mixed model which includes a random intercept and logit link. The model includes all S-K data values collected at the scheduled visits between Days 8-29, dichotomized as normal and abnormal, as response variables, and baseline covariates. Placebo is the reference group.||21.00|6.45|<0.001
72502500|NCT03528681|144535705|OTHER|The model included normokalaemia status (yes, no) on Day 29 as binary response variables, and baseline covariates. Placebo is the reference group.|Odds Ratio (OR)|2.54||||0.035|TWO_SIDED|95.0|1.07|6.05|||Regression, Logistic|||||6.05|1.07|0.035
72502501|NCT03528681|144535705|OTHER||Odds Ratio (OR)|6.25|||<|0.001|TWO_SIDED|95.0|2.56|15.27|||Regression, Logistic|||The model included normokalaemia status (yes, no) on Day 29 as binary response variables, and baseline covariates. Placebo is the reference group.||15.27|2.56|<0.001
72464972|NCT00562484|144452551|SUPERIORITY_OR_OTHER||Vaccine efficacy|60.0|||||TWO_SIDED|95.0|44.0|72.0||||||Vaccine efficacy = 100 x (1 - ratio of incidence rate)||72|44|
72464973|NCT02811302|144452563|OTHER|A simple count and percentage of the population were calculated based on the number of patients adjudicated as having Respiratory Depression.|||||||||||||||||To determine the risk assessment score, first the number of patients with Respiratory Depression (RD) had to be identified. Per the rules established for the Clinical Endpoint Committee, 655 (43.6%) patients were identified as having RD.|||
72502502|NCT03528681|144535706|OTHER||Median Difference (Final Values)|5.72|||<|0.001|TWO_SIDED|95.0|3.13|8.31|||Regression, Linear|||Results derived from a linear regression model with the following covariates: treatment group; baseline S-K values (Open-label phase and Randomized treatment phase); baseline eGFR; age category; country; baseline RAAS inhibitor, chronic kidney disease, heart failure, and diabetes mellitus statuses.||8.31|3.13|<0.001
72502503|NCT03528681|144535706|OTHER||Mean Difference (Final Values)|11.14|||<|0.001|TWO_SIDED|95.0|8.57|13.71|||Regression, Linear|||Results derived from a linear regression model with the following covariates: treatment group; baseline S-K values (Open-label phase and Randomized treatment phase); baseline eGFR; age category; country; baseline RAAS inhibitor, chronic kidney disease, heart failure, and diabetes mellitus statuses.||13.71|8.57|<0.001
72502504|NCT03528681|144535709|OTHER||Mean Difference (Final Values)|-105.248|||<|0.001|TWO_SIDED|95.0|-161.293|-49.203|||Mixed Models Analysis|||S-Aldo Results derived from a longitudinal mixed model adjusted for treatment, visit, treatment-by-visit interaction and baseline covariates||-49.203|-161.293|<0.001
72502505|NCT03528681|144535709|OTHER||Median Difference (Final Values)|-137.267|||<|0.001|TWO_SIDED|95.0|-192.596|-81.937|||Mixed Models Analysis|||S-Aldo Results derived from a longitudinal mixed model adjusted for treatment, visit, treatment-by-visit interaction and baseline covariates||-81.937|-192.596|<0.001
72393986|NCT01059825|144294291|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.69||||0.289|TWO_SIDED|80.0|-2.27|0.9||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||0.90|-2.27|0.289
72502506|NCT03528681|144535709|OTHER||Mean Difference (Final Values)|0.014||||0.839|TWO_SIDED|95.0|-0.12|0.147|||Mixed Models Analysis|||P-Renin Results derived from a longitudinal mixed model adjusted for treatment, visit, treatment-by-visit interaction and baseline covariates||0.147|-0.120|0.839
72502507|NCT03528681|144535709|OTHER||Mean Difference (Final Values)|-0.062||||0.355|TWO_SIDED|95.0|-0.195|0.07|||Mixed Models Analysis|||P-Renin Results derived from a longitudinal mixed model adjusted for treatment, visit, treatment-by-visit interaction and baseline covariates||0.070|-0.195|0.355
72502508|NCT03528681|144535711|OTHER||Hazard Ratio (HR)|0.39|||<|0.001|TWO_SIDED|95.0|0.27|0.57|||Regression, Cox|||The model included time to reoccurrence of hyperkalaemia as response variable (event: hyperkalaemia or discontinue treatment in RTP due to high S-K levels), baseline eGFR, OLP and RTP baseline S-K values as well as age (\< 55, 55-64, \> 64 years) and baseline binary indicators for RAASi, chronic kidney disease, heart failure, and diabetes mellitus as covariates. Placebo is the reference group||0.57|0.27|<0.001
72502509|NCT03528681|144535711|OTHER||Hazard Ratio (HR)|0.16|||<|0.001|TWO_SIDED|95.0|0.1|0.25|||Regression, Cox|||The model included time to reoccurrence of hyperkalaemia as response variable (event: hyperkalaemia or discontinue treatment in RTP due to high S-K levels), baseline eGFR, OLP and RTP baseline S-K values as well as age (\< 55, 55-64, \> 64 years) and baseline binary indicators for RAASi, chronic kidney disease, heart failure, and diabetes mellitus as covariates. Placebo is the reference group||0.25|0.10|<0.001
72502510|NCT00955110|144535712|SUPERIORITY_OR_OTHER||Least Square Means Difference|-28.8|||<|0.001|TWO_SIDED|95.0|-41.6|-16.0||A mixed-effect model for a crossover study was used, including treatment, period, treatment sequence and first-order carryover effect as fixed effects, pre-dose measurement as covariate, and subjects nested within treatment sequence as random effect.|ANCOVA|||||-16.0|-41.6|<0.001
72502511|NCT00955110|144535712|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-50.5|||<|0.001|TWO_SIDED|95.0|-63.4|-37.5||A mixed-effect model for a crossover study was used, including treatment, period, treatment sequence and first-order carryover effect as fixed effects, pre-dose measurement as covariate, and subjects nested within treatment sequence as random effect.|ANCOVA|||||-37.5|-63.4|<0.001
72502512|NCT00955110|144535712|SUPERIORITY_OR_OTHER||Least Square Mean Difference|5.5||||0.395|TWO_SIDED|95.0|-7.3|18.3||A mixed-effect model for a crossover study was used, including treatment, period, treatment sequence and first-order carryover effect as fixed effects, pre-dose measurement as covariate, and subjects nested within treatment sequence as random effect.|ANCOVA|||||18.3|-7.3|0.395
72502513|NCT00955110|144535712|SUPERIORITY_OR_OTHER||Least Square Mean Difference|38.0|||<|0.001|TWO_SIDED|95.0|25.2|50.8||A mixed-effect model for a crossover study was used, including treatment, period, treatment sequence and first-order carryover effect as fixed effects, pre-dose measurement as covariate, and subjects nested within treatment sequence as random effect.|ANCOVA|||||50.8|25.2|<0.001
72502514|NCT00955110|144535712|SUPERIORITY_OR_OTHER||Least Square Mean Difference|56.0|||<|0.001|TWO_SIDED|95.0|43.1|68.9||A mixed-effect model for a crossover study was used, including treatment, period, treatment sequence and first-order carryover effect as fixed effects, pre-dose measurement as covariate, and subjects nested within treatment sequence as random effect.|ANCOVA|||||68.9|43.1|<0.001
72502515|NCT00955110|144535712|SUPERIORITY_OR_OTHER||Least Square Mean Difference|66.8|||<|0.001|TWO_SIDED|95.0|53.9|79.7||A mixed-effect model for a crossover study was used, including treatment, period, treatment sequence and first-order carryover effect as fixed effects, pre-dose measurement as covariate, and subjects nested within treatment sequence as random effect.|ANCOVA|||||79.7|53.9|<0.001
72502516|NCT02907944|144535749|SUPERIORITY||Odds Ratio (OR)|1.09||||0.55|TWO_SIDED|95.0|0.82|1.45|||Generalized Estimating Equation|||||1.45|0.82|0.55
72502517|NCT02907944|144535749|SUPERIORITY||Odds Ratio (OR)|1.76||||0.09|TWO_SIDED|95.0|0.92|3.37|||Generalized Estimating Equation|||||3.37|0.92|0.09
72502518|NCT02907944|144535749|SUPERIORITY||Odds Ratio (OR)|1.4||||0.001|TWO_SIDED|95.0|1.14|1.71|||Generalized Estimating Equation|||||1.71|1.14|0.001
72502519|NCT02907944|144535750|SUPERIORITY||Odds Ratio (OR)|1.08||||0.59|TWO_SIDED|95.0|0.81|1.45|||Generalized Estimating Equation|||||1.45|0.81|0.59
72502520|NCT02907944|144535750|SUPERIORITY||Odds Ratio (OR)|1.77||||0.11|TWO_SIDED|95.0|0.88|3.55|||Generalized Estimating Equation|||||3.55|0.88|0.11
72564056|NCT01115855|144659710|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-364.65|STANDARD_ERROR_OF_MEAN|763.83|||TWO_SIDED|95.0|-1863.06|1133.76||||||Change from baseline at Month 5 :Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||1133.76|-1863.06|
72393987|NCT01059825|144294291|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.7||||0.288|TWO_SIDED|80.0|-2.31|0.91||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||0.91|-2.31|0.288
72502521|NCT02907944|144535750|SUPERIORITY||Odds Ratio (OR)|1.35||||0.005|TWO_SIDED|95.0|1.09|1.66|||Generalized Estimating Equation|||||1.66|1.09|0.005
72502522|NCT03715465|144535764|SUPERIORITY|||||||0.51|||||||t-test, 2 sided|||||||0.510
72502523|NCT03715465|144535765|SUPERIORITY|||||||0.411|||||||t-test, 2 sided|||Per diary||||0.411
72502524|NCT03715465|144535765|SUPERIORITY|||||||0.92|||||||t-test, 2 sided|||Per wrist actigraphy||||0.920
72502525|NCT03715465|144535766|SUPERIORITY|||||||0.787|||||||t-test, 2 sided|||Per diary||||0.787
72502526|NCT03715465|144535766|SUPERIORITY|||||||0.916|||||||t-test, 2 sided|||Per wrist actigraphy||||0.916
72502527|NCT03715465|144535767|SUPERIORITY|||||||0.27|||||||t-test, 2 sided|||Per diary||||0.270
72502528|NCT03715465|144535767|SUPERIORITY|||||||0.406|||||||t-test, 2 sided|||Per wrist actigraphy||||0.406
72502529|NCT03715465|144535768|SUPERIORITY|||||||0.635|||||||t-test, 2 sided|||Per diary||||0.635
72502530|NCT03715465|144535768|SUPERIORITY|||||||0.383|||||||t-test, 2 sided|||Per wrist actigraphy||||0.383
72393988|NCT01059825|144294291|SUPERIORITY_OR_OTHER||Difference in least squares means|-1.41||||0.13|TWO_SIDED|80.0|-3.01|0.19||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||0.19|-3.01|0.130
72393989|NCT01059825|144294291|SUPERIORITY_OR_OTHER||Difference in least squares means|-2.44||||0.026|TWO_SIDED|80.0|-4.05|-0.84||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-0.84|-4.05|0.026
72393990|NCT01059825|144294291|SUPERIORITY_OR_OTHER||Difference in least squares means|1.49||||0.883|TWO_SIDED|80.0|-0.11|3.08||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||3.08|-0.11|0.883
72393991|NCT01059825|144294292|SUPERIORITY_OR_OTHER||Difference in least squares means|-1.67||||0.063|TWO_SIDED|80.0|-3.07|-0.27||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-0.27|-3.07|0.063
72393992|NCT01059825|144294292|SUPERIORITY_OR_OTHER||Difference in least squares means|-2.29||||0.019|TWO_SIDED|80.0|-3.69|-0.88||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-0.88|-3.69|0.019
72393993|NCT01059825|144294292|SUPERIORITY_OR_OTHER||Difference in least squares means|-2.01||||0.035|TWO_SIDED|80.0|-3.43|-0.59||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-0.59|-3.43|0.035
72393994|NCT01059825|144294292|SUPERIORITY_OR_OTHER||Difference in least squares means|-1.3||||0.121|TWO_SIDED|80.0|-2.73|0.12||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||0.12|-2.73|0.121
72502531|NCT03715465|144535769|SUPERIORITY|||||||0.456|||||||t-test, 2 sided|||||||0.456
72502532|NCT03715465|144535770|SUPERIORITY|||||||0.402|||||||t-test, 2 sided|||||||0.402
72502533|NCT03715465|144535771|SUPERIORITY|||||||0.047|||||||t-test, 2 sided|||||||0.047
72502534|NCT03715465|144535772|SUPERIORITY|||||||0.525|||||||t-test, 2 sided|||||||0.525
72502535|NCT03715465|144535773|SUPERIORITY|||||||0.106|||||||t-test, 2 sided|||||||0.106
72502536|NCT03715465|144535774|SUPERIORITY|||||||0.059|||||||t-test, 2 sided|||||||0.059
72502537|NCT03715465|144535775|SUPERIORITY|||||||0.007|||||||t-test, 2 sided|||||||0.007
72502538|NCT03715465|144535776|SUPERIORITY|||||||0.246|||||||t-test, 2 sided|||||||0.246
72502539|NCT03715465|144535777|SUPERIORITY|||||||0.333|||||||t-test, 2 sided|||||||0.333
72502540|NCT04902885|144535779|SUPERIORITY|||||||0.0003|||||||non-parametric ANCOVA|||70 subjects (35 per group) provided approximately 95% power at the test level of α = 0.05 (2-sided) .Assuming a dropout rate of approximately 12%, the sample size for Part II was 80 subjects (40 per group)||||0.0003
72564057|NCT01115855|144659710|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-247.14|STANDARD_ERROR_OF_MEAN|711.26|||TWO_SIDED|95.0|-1642.43|1148.14||||||Change from baseline at Month 9 : Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||1148.14|-1642.43|
72564058|NCT01115855|144659710|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-370.14|STANDARD_ERROR_OF_MEAN|699.58|||TWO_SIDED|95.0|-1742.51|1002.22||||||Change from baseline at Month 13 : Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||1002.22|-1742.51|
72564059|NCT01115855|144659710|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-664.09|STANDARD_ERROR_OF_MEAN|11059.62|||TWO_SIDED|95.0|-141189.93|139861.75||||||Change from baseline at Month 17 : Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||139861.75|-141189.93|
72502541|NCT00756002|144535796|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values are from t-tests of the ANCOVA model for the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|Least Squares (LS) means from ANCOVA model with effects for treatment and pooled center, with Baseline as a covariate.||One subject did not have postsleep questionnaire data on day 2; however, had polysomnography data recorded. Analysis was based on LOCF data.||||<0.001
72502542|NCT00756002|144535797|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values are from t-tests of the ANCOVA model for the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from ANCOVA model with effects for treatment and pooled center, with Baseline as a covariate.||||||<0.001
72502543|NCT00756002|144535798|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values are from t-tests of the ANCOVA model for the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from ANCOVA model with effects for treatment and pooled center, with Baseline as a covariate.||||||<0.001
72502544|NCT00756002|144535799|SUPERIORITY_OR_OTHER|||||||0.003||95.0||||P-values are from t-tests of the ANCOVA model for the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from ANCOVA model with effects for treatment and pooled center, with Baseline as a covariate.||One subject did not have postsleep questionnaire data on day 2; however, had polysomnography data recorded. Analysis was based on LOCF data.||||0.003
72502545|NCT00756002|144535800|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values are from t-tests of the ANCOVA model for the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from ANCOVA model with effects for treatment and pooled center, with Baseline as a covariate.||||||<0.001
72502546|NCT00756002|144535801|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values are from t-tests of the ANCOVA model for the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from ANCOVA model with effects for treatment and pooled center, with Baseline as a covariate.||||||<0.001
72464974|NCT02811302|144452564|OTHER|Multivariable model for (Multivariate logistic regression) Respiratory Depression, followed by validation with Harrell's Optimism using a bootstrap sampling method.|Area Under the Curve|0.76|||||TWO_SIDED|95.0|0.73|0.79|||||The model was performed using stepwise selection including all potential predictors and interactions terms (medical history and baseline characteristics).|A modified Full Analysis Dataset (1335) was used to derive and validate the risk assessment tool. Subjects were excluded if they had major deviations or consent withdrawals. Subjects that did not have any monitoring data were also excluded. Finally, 69 subjects were further excluded from the model, as they were missing parameters to calculate their risk score.|The model derived from the logistic regression was assessed by the Hosmer-Lemshow goodness of fit test (P = 0.831). The derived model was validated by Harrell's Optimism using a Bootstrap sampling method (500 samples from the modified dataset, 1335) with replacement. The logistic regression model with stepwise selection was performed for each bootstrap sample, and AUC calculated. The optimism calculated by Harrell's algorithm was 0.02. The model was then checked for the quartiles of the effective monitoring and for geography used as a random effect. The performance measurement of the final model was adjusted according the Harrell's Optimism for a final adjusted AUC of 0.74.|0.79|0.73|
72464975|NCT00942188|144452573|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.854|||||TWO_SIDED|95.0|-1.94|0.23|||ANCOVA|||||0.23|-1.94|
72464976|NCT00942188|144452573|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.252|||||TWO_SIDED|95.0|-2.48|-0.03|||ANCOVA|||||-0.03|-2.48|
72464977|NCT00942188|144452573|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.61|||||TWO_SIDED|95.0|-1.76|0.54|||ANCOVA|||||0.54|-1.76|
72564060|NCT01115855|144659710|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-414.99|STANDARD_ERROR_OF_MEAN|3071.77|||TWO_SIDED|95.0|-39445.52|38615.54||||||Change from baseline at Month 21 :Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||38615.54|-39445.52|
72564061|NCT01115855|144659710|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|23.86|STANDARD_ERROR_OF_MEAN|10794.85|||TWO_SIDED|95.0|-21649.89|21697.6||||||Change from baseline at Month 25 : Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||21697.60|-21649.89|
72564062|NCT01115855|144659710|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-245.23|STANDARD_ERROR_OF_MEAN|6698.57|||TWO_SIDED|95.0|-85358.69|84868.22||||||Change from baseline at Month 29 : Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||84868.22|-85358.69|
72564063|NCT01115855|144659710|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|170.49|STANDARD_ERROR_OF_MEAN|10730.38|||TWO_SIDED|95.0|-21375.69|21716.66||||||Change from baseline at Month 33 : Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||21716.66|-21375.69|
72564064|NCT01115855|144659710|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-58.77|STANDARD_ERROR_OF_MEAN|12765.3|||TWO_SIDED|95.0|-30160.25|30042.7||||||Change from baseline at Month 37 : Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||30042.70|-30160.25|
72564065|NCT01115855|144659710|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-212.25|STANDARD_ERROR_OF_MEAN|11073.11|||TWO_SIDED|90.0|-22723.82|22299.33||||||Change from baseline at Month 42 : Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||22299.33|-22723.82|
72564066|NCT01115855|144659710|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-80.16|STANDARD_ERROR_OF_MEAN|11486.21|||TWO_SIDED|95.0|-146026.28|145865.96||||||Change from baseline at Month 48 : Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||145865.96|-146026.28|
72564067|NCT01115855|144659710|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-187.72|STANDARD_ERROR_OF_MEAN|240.96|||TWO_SIDED|95.0|-662.67|287.23||||||Change from baseline at Month 13 : ANCOVA with treatment effect and covariates of the NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||287.23|-662.67|
72564068|NCT01115855|144659711|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|1.71|STANDARD_ERROR_OF_MEAN|1.14|||TWO_SIDED|95.0|-0.55|3.96||||||Change from baseline at Month 5 : Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||3.96|-0.55|
72464978|NCT00942188|144452574|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-2.995|||||TWO_SIDED|95.0|-9.82|3.83|||ANCOVA|||||3.83|-9.82|
72464979|NCT00942188|144452574|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-2.324|||||TWO_SIDED|95.0|-10.21|5.56|||ANCOVA|||||5.56|-10.21|
72464980|NCT00942188|144452574|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.635|||||TWO_SIDED|95.0|-9.16|5.89|||ANCOVA|||||5.89|-9.16|
72464981|NCT00942188|144452576|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.27|||||TWO_SIDED|95.0|-0.59|0.05||This is the estimated value for week 10 HbA1c.|ANCOVA|||||0.05|-0.59|
72464982|NCT00942188|144452576|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.369|||||TWO_SIDED|95.0|-0.74|0.0||This is the estimated value for HbA1c at Week 10.|ANCOVA|||||0.00|-0.74|
72464983|NCT00942188|144452576|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.227|||||TWO_SIDED|95.0|-0.59|0.13||This is the estimated value for HbA1c at Week 10.|ANCOVA|||||0.13|-0.59|
72464984|NCT00942188|144452576|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.267|||||TWO_SIDED|95.0|-0.61|0.08||This is the estimated value for HbA1c at week 12.|ANCOVA|||||0.08|-0.61|
72464985|NCT00942188|144452576|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.396|||||TWO_SIDED|95.0|-0.79|0.0||This is the estimated value for HbA1c at Week 12.|ANCOVA|||||0.00|-0.79|
72464986|NCT00942188|144452576|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.221|||||TWO_SIDED|95.0|-0.59|0.15||This is the estimated value for HbA1c at week 12.|ANCOVA|||||0.15|-0.59|
72464987|NCT01568112|144452635|SUPERIORITY_OR_OTHER||Difference in percentage|-9.0|||||TWO_SIDED|95.0|-30.8|12.9|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Overall flushing events||12.9|-30.8|
72464988|NCT01568112|144452635|SUPERIORITY_OR_OTHER||Difference in percentage|7.0|||||TWO_SIDED|95.0|-14.1|27.8|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Overall flushing events||27.8|-14.1|
72464989|NCT01568112|144452635|SUPERIORITY_OR_OTHER||Difference in percentage|-9.0|||||TWO_SIDED|95.0|-30.8|12.9|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Overall redness events||12.9|-30.8|
72464990|NCT01568112|144452635|SUPERIORITY_OR_OTHER||Difference in percentage|4.0|||||TWO_SIDED|95.0|-16.4|25.5|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Overall redness events||25.5|-16.4|
72464991|NCT01568112|144452635|SUPERIORITY_OR_OTHER||Difference in percentage|-21.0|||||TWO_SIDED|95.0|-41.7|1.3|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Overall tingling events||1.3|-41.7|
72464992|NCT01568112|144452635|SUPERIORITY_OR_OTHER||Difference in percentage|-3.0|||||TWO_SIDED|95.0|-23.3|18.7|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Overall tingling events||18.7|-23.3|
72502547|NCT00756002|144535802|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values are from t-tests of the ANCOVA model for the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from ANCOVA model with effects for treatment and pooled center, with Baseline as a covariate.||||||<0.001
72502548|NCT00756002|144535803|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values are from t-tests of the ANCOVA model for the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from ANCOVA model with effects for treatment and pooled center, with Baseline as a covariate.||||||<0.001
72464993|NCT01568112|144452635|SUPERIORITY_OR_OTHER||Difference in percentage|-14.0|||||TWO_SIDED|95.0|-35.2|8.3|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Overall itching events||8.3|-35.2|
72502549|NCT00756002|144535804|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values are from t-tests of the ANCOVA model for the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from ANCOVA model with effects for treatment and pooled center, with Baseline as a covariate.||||||<0.001
72464994|NCT01568112|144452635|SUPERIORITY_OR_OTHER||Difference in percentage|12.0|||||TWO_SIDED|95.0|-9.5|32.2|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Overall itching events||32.2|-9.5|
72464995|NCT01568112|144452635|SUPERIORITY_OR_OTHER||Difference in percentage|-9.0|||||TWO_SIDED|95.0|-30.8|12.9|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Overall warmth events||12.9|-30.8|
72502550|NCT00756002|144535805|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values are from t-tests of the ANCOVA model for the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from ANCOVA model with effects for treatment and pooled center, with Baseline as a covariate.||||||<0.001
72464996|NCT01568112|144452635|SUPERIORITY_OR_OTHER||Difference in percentage|5.0|||||TWO_SIDED|95.0|-16.4|25.5|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Overall warmth events||25.5|-16.4|
72464997|NCT01568112|144452636|SUPERIORITY_OR_OTHER||Difference in percentage|-14.0|||||TWO_SIDED|95.0|-35.2|8.3|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Overall flushing events||8.3|-35.2|
72464998|NCT01568112|144452636|SUPERIORITY_OR_OTHER||Difference in percentage|12.0|||||TWO_SIDED|95.0|-9.5|32.2|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Overall flushing events||32.2|-9.5|
72464999|NCT01568112|144452636|SUPERIORITY_OR_OTHER||Difference in percentage|-19.0|||||TWO_SIDED|95.0|-39.6|3.7|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Redness events||3.7|-39.6|
72465000|NCT01568112|144452636|SUPERIORITY_OR_OTHER||Difference in percentage|7.0|||||TWO_SIDED|95.0|-14.1|27.8|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Redness events||27.8|-14.1|
72465001|NCT01568112|144452636|SUPERIORITY_OR_OTHER||Difference in percentage|-21.0|||||TWO_SIDED|95.0|-41.7|1.3|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Warmth events||1.3|-41.7|
72465002|NCT01568112|144452636|SUPERIORITY_OR_OTHER||Difference in percentage|7.0|||||TWO_SIDED|95.0|-14.1|27.8|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Warmth events||27.8|-14.1|
72465003|NCT01568112|144452636|SUPERIORITY_OR_OTHER||Difference in percentage|-33.0|||||TWO_SIDED|95.0|-52.2|-10.6|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Tingling events||-10.6|-52.2|
72465004|NCT01568112|144452636|SUPERIORITY_OR_OTHER||Difference in percentage|0.0|||||TWO_SIDED|95.0|-21.0|21.0|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Tingling events||21.0|-21.0|
72465005|NCT01568112|144452636|SUPERIORITY_OR_OTHER||Difference in percentage|-21.0|||||TWO_SIDED|95.0|-41.7|1.3|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Itching events||1.3|-41.7|
72465006|NCT01568112|144452636|SUPERIORITY_OR_OTHER||Difference in percentage|18.0|||||TWO_SIDED|95.0|-2.4|38.8|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Itching events||38.8|-2.4|
72465007|NCT01568112|144452637|SUPERIORITY_OR_OTHER||Difference in percentage|-14.0|||||TWO_SIDED|95.0|-35.6|9.2|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Overall flushing events||9.2|-35.6|
72502551|NCT00756002|144535806|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values are from t-tests of the ANCOVA model for the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from ANCOVA model with effects for treatment and pooled center, with Baseline as a covariate.||||||<0.001
72564069|NCT01115855|144659711|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|2.74|STANDARD_ERROR_OF_MEAN|1.36|||TWO_SIDED|95.0|0.07|5.42||||||Change from baseline at Month 9 : Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||5.42|0.07|
72465008|NCT01568112|144452637|SUPERIORITY_OR_OTHER||Difference in percentage|-2.0|||||TWO_SIDED|95.0|-24.7|21.7|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Overall flushing events||21.7|-24.7|
72465009|NCT01568112|144452637|SUPERIORITY_OR_OTHER||Difference in percentage|-14.0|||||TWO_SIDED|95.0|-35.6|9.2|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Redness events||9.2|-35.6|
72502552|NCT00756002|144535807|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values are from t-tests of the ANCOVA model for the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from ANCOVA model with effects for treatment and pooled center, with Baseline as a covariate.||||||<0.001
72502553|NCT00756002|144535808|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||LS means from ANCOVA model with effects for treatment \& pooled center, with Baseline as a covariate. P-values from t-tests of the ANCOVA model for the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|||||||<0.001
72502554|NCT00756002|144535809|SUPERIORITY_OR_OTHER|||||||0.043||95.0||||LS means from ANCOVA model with effects for treatment \& pooled center, with Baseline as a covariate. P-values from t-tests of the ANCOVA model for the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|||||||0.043
72502555|NCT00756002|144535810|SUPERIORITY_OR_OTHER|||||||0.005||95.0||||P-values for differences are obtained using t-tests from the ANCOVA model of the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from an ANCOVA model with effects for treatment and pooled center, with Baseline as a covariate.||||||0.005
72502556|NCT00756002|144535811|SUPERIORITY_OR_OTHER|||||||0.01||95.0||||P-values for differences are obtained using t-tests from the ANCOVA model of the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from an ANCOVA model with effects for treatment and pooled center, with Baseline as a covariate.||||||0.010
72502557|NCT00756002|144535812|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||P-values for differences are obtained using t-tests from the ANCOVA model of the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from an ANCOVA model with effects for treatment and pooled center, with Baseline as a covariate.||||||0.002
72502558|NCT00756002|144535813|SUPERIORITY_OR_OTHER|||||||0.006||95.0||||P-values for differences are obtained using t-tests from the ANCOVA model of the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from an ANCOVA model with effects for treatment and pooled center, with Baseline as a covariate.||||||0.006
72502559|NCT00756002|144535814|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values for differences are obtained using t-tests from the ANCOVA model of the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from an ANCOVA model with effects for treatment and pooled center, with the Baseline value as a covariate.||||||<0.001
72564070|NCT01115855|144659711|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|3.86|STANDARD_ERROR_OF_MEAN|1.39|||TWO_SIDED|95.0|1.11|6.6||||||Change from baseline at Month 13 : Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||6.60|1.11|
72564071|NCT01115855|144659711|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|4.86|STANDARD_ERROR_OF_MEAN|1.54|||TWO_SIDED|95.0|1.81|7.9||||||Change from baseline at Month 17 : Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||7.90|1.81|
72564072|NCT01115855|144659711|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|5.65|STANDARD_ERROR_OF_MEAN|1.67|||TWO_SIDED|95.0|2.36|8.94||||||Change from baseline at Month 21 : Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||8.94|2.36|
72465010|NCT01568112|144452637|SUPERIORITY_OR_OTHER||Difference in percentage|0.0|||||TWO_SIDED|95.0|-22.9|23.7|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Redness events||23.7|-22.9|
72465011|NCT01568112|144452637|SUPERIORITY_OR_OTHER||Difference in percentage|-11.0|||||TWO_SIDED|95.0|-33.0|11.9|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Warmth events||11.9|-33.0|
72502560|NCT00756002|144535815|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values for differences are obtained using t-tests from the ANCOVA model of the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from an ANCOVA model with effects for treatment and pooled center, with the Baseline value as a covariate.||||||<0.001
72502561|NCT00756002|144535816|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values for differences are obtained using t-tests from the ANCOVA model of the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from an ANCOVA model with effects for treatment and pooled center, with the Baseline value as a covariate.||||||<0.001
72502562|NCT00756002|144535817|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values for differences are obtained using t-tests from the ANCOVA model of the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from an ANCOVA model with effects for treatment and pooled center, with Baseline as a covariate.||||||<0.001
72502563|NCT00756002|144535818|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values for differences are obtained using t-tests from the ANCOVA model of the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from an ANCOVA model with effects for treatment and pooled center, with Baseline as a covariate.||||||<0.001
72502564|NCT00756002|144535819|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values for differences are obtained using t-tests from the ANCOVA model of the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from an ANCOVA model with effects for treatment and pooled center, with Baseline as a covariate.||||||<0.001
72465012|NCT01568112|144452637|SUPERIORITY_OR_OTHER||Difference in percentage|-5.0|||||TWO_SIDED|95.0|-27.5|18.8|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Warmth events||18.8|-27.5|
72465013|NCT01568112|144452637|SUPERIORITY_OR_OTHER||Difference in percentage|-17.0|||||TWO_SIDED|95.0|-38.1|6.5|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Tingling events||6.5|-38.1|
72465014|NCT01568112|144452637|SUPERIORITY_OR_OTHER||Difference in percentage|-11.0|||||TWO_SIDED|95.0|-34.2|12.2|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Tingling events||12.2|-34.2|
72465015|NCT01568112|144452637|SUPERIORITY_OR_OTHER||Difference in percentage|-20.0|||||TWO_SIDED|95.0|-40.6|3.8|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Itching events||3.8|-40.6|
72465016|NCT01568112|144452637|SUPERIORITY_OR_OTHER||Difference in percentage|-18.0|||||TWO_SIDED|95.0|-40.2|5.5|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Itching events||5.5|-40.2|
72465017|NCT01568112|144452638|SUPERIORITY_OR_OTHER||Mean difference|-1.9|STANDARD_ERROR_OF_MEAN|0.53|||TWO_SIDED|95.0|-3.0|-0.9|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Overall flushing events||-0.9|-3.0|
72465018|NCT01568112|144452638|SUPERIORITY_OR_OTHER||Mean difference|1.2|STANDARD_ERROR_OF_MEAN|0.54|||TWO_SIDED|95.0|0.2|2.3|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Overall flushing events||2.3|0.2|
72502565|NCT00756002|144535820|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values for differences are obtained using t-tests from the ANCOVA model of the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from an ANCOVA model with effects for treatment and pooled center, with Baseline as a covariate.||||||<0.001
72502566|NCT00756002|144535821|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values for differences are obtained using t-tests from the ANCOVA model of the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from an ANCOVA model with effects for treatment and pooled center, with Baseline as a covariate.||||||<0.001
72502567|NCT00756002|144535822|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values for differences are obtained using t-tests from the ANCOVA model of the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from an ANCOVA model with effects for treatment and pooled center, with Baseline as a covariate.||||||<0.001
72502568|NCT00756002|144535823|SUPERIORITY_OR_OTHER|||||||0.785||95.0||||P-values for differences are obtained using t-tests from the ANCOVA model of the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from an ANCOVA model with effects for treatment and pooled center, with Baseline as a covariate.||||||0.785
72564073|NCT01115855|144659711|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|3.44|STANDARD_ERROR_OF_MEAN|1.68|||TWO_SIDED|95.0|0.12|6.75||||||Change from baseline at Month 25 :Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||6.75|0.12|
72564074|NCT01115855|144659711|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|3.6|STANDARD_ERROR_OF_MEAN|1.85|||TWO_SIDED|95.0|-0.06|7.25||||||Change from baseline at Month 29 : Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||7.25|-0.06|
72564075|NCT01115855|144659711|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|4.65|STANDARD_ERROR_OF_MEAN|1.92|||TWO_SIDED|95.0|0.86|8.44||||||Change from baseline at Month 33 :Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||8.44|0.86|
72465019|NCT01568112|144452638|SUPERIORITY_OR_OTHER||Mean difference|-2.2|STANDARD_ERROR_OF_MEAN|0.5|||TWO_SIDED|95.0|-3.2|-1.2|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Redness events||-1.2|-3.2|
72465020|NCT01568112|144452638|SUPERIORITY_OR_OTHER||Mean difference|1.3|STANDARD_ERROR_OF_MEAN|0.62|||TWO_SIDED|95.0|0.1|2.5|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Redness events||2.5|0.1|
72465021|NCT01568112|144452638|SUPERIORITY_OR_OTHER||Mean difference|-1.7|STANDARD_ERROR_OF_MEAN|0.51|||TWO_SIDED|95.0|-2.8|-0.7|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Warmth events||-0.7|-2.8|
72465022|NCT01568112|144452638|SUPERIORITY_OR_OTHER||Mean difference|1.2|STANDARD_ERROR_OF_MEAN|0.53|||TWO_SIDED|95.0|0.1|2.3|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Warmth events||2.3|0.1|
72465023|NCT01568112|144452638|SUPERIORITY_OR_OTHER||Mean difference|-1.8|STANDARD_ERROR_OF_MEAN|0.47|||TWO_SIDED|95.0|-2.7|-0.9|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Tingling events||-0.9|-2.7|
72465024|NCT01568112|144452638|SUPERIORITY_OR_OTHER||Mean difference|0.6|STANDARD_ERROR_OF_MEAN|0.52|||TWO_SIDED|95.0|-0.4|1.6|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Tingling events||1.6|-0.4|
72502569|NCT00756002|144535824|SUPERIORITY_OR_OTHER|||||||0.422||95.0||||P-values for differences are obtained using t-tests from the ANCOVA model of the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from an ANCOVA model with effects for treatment and pooled center, with Baseline as a covariate.||||||0.422
72502570|NCT00756002|144535825|SUPERIORITY_OR_OTHER|||||||0.665||95.0||||P-values for differences are obtained using t-tests from the ANCOVA model of the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from an ANCOVA model with effects for treatment and pooled center, with Baseline as a covariate.||||||0.665
72502571|NCT00756002|144535826|SUPERIORITY_OR_OTHER|||||||0.228||95.0||||P-values for differences are obtained using t-tests from the ANCOVA model of the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from an ANCOVA model with effects for treatment and pooled center, with Baseline as a covariate.||||||0.228
72502572|NCT00756002|144535827|SUPERIORITY_OR_OTHER|||||||0.099||95.0||||P-values for differences are obtained using t-tests from the ANCOVA model of the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from an ANCOVA model with effects for treatment and pooled center, with Baseline as a covariate.||||||0.099
72465025|NCT01568112|144452638|SUPERIORITY_OR_OTHER||Mean difference|-1.9|STANDARD_ERROR_OF_MEAN|0.46|||TWO_SIDED|95.0|-2.8|-1.0|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Itching events||-1.0|-2.8|
72465026|NCT01568112|144452638|SUPERIORITY_OR_OTHER||Mean difference|1.2|STANDARD_ERROR_OF_MEAN|0.5|||TWO_SIDED|95.0|0.2|2.2|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Itching events||2.2|0.2|
72465027|NCT01568112|144452639|SUPERIORITY_OR_OTHER||Mean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.62|||TWO_SIDED|95.0|-1.7|0.8|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Overall flushing events||0.8|-1.7|
72465028|NCT01568112|144452639|SUPERIORITY_OR_OTHER||Mean difference|-0.7|STANDARD_ERROR_OF_MEAN|0.57|||TWO_SIDED|95.0|-1.8|0.4|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Overall flushing events||0.4|-1.8|
72465029|NCT01568112|144452639|SUPERIORITY_OR_OTHER||Mean difference|-0.7|STANDARD_ERROR_OF_MEAN|0.63|||TWO_SIDED|95.0|-2.0|0.6|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Redness events||0.6|-2.0|
72465030|NCT01568112|144452639|SUPERIORITY_OR_OTHER||Mean difference|-0.7|STANDARD_ERROR_OF_MEAN|0.61|||TWO_SIDED|95.0|-1.9|0.5|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Redness events||0.5|-1.9|
72465031|NCT01568112|144452639|SUPERIORITY_OR_OTHER||Mean difference|-0.8|STANDARD_ERROR_OF_MEAN|0.59|||TWO_SIDED|95.0|-2.0|0.4|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Warmth events||0.4|-2.0|
72465032|NCT01568112|144452639|SUPERIORITY_OR_OTHER||Mean difference|-0.9|STANDARD_ERROR_OF_MEAN|0.56|||TWO_SIDED|95.0|-2.1|0.2|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Warmth events||0.2|-2.1|
72502573|NCT00756002|144535828|SUPERIORITY_OR_OTHER|||||||0.005||95.0||||P-values for differences are obtained using t-tests from the ANCOVA model of the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from an ANCOVA model with effects for treatment and pooled center, with Baseline as a covariate.||||||0.005
72502574|NCT00756002|144535829|SUPERIORITY_OR_OTHER|||||||0.004||95.0||||P-values for differences are obtained using t-tests from the ANCOVA model of the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from an ANCOVA model with effects for treatment and pooled center, with Baseline as a covariate.||||||0.004
72502575|NCT00756002|144535830|SUPERIORITY_OR_OTHER|||||||0.001||95.0||||P-values for differences are obtained using t-tests from the ANCOVA model of the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from an ANCOVA model with effects for treatment and pooled center, with Baseline as a covariate.||||||0.001
72502576|NCT00756002|144535831|SUPERIORITY_OR_OTHER|||||||0.004||95.0||||P-values for differences are obtained using t-tests from the ANCOVA model of the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from an ANCOVA model with effects for treatment and pooled center, with Baseline as a covariate.||||||0.004
72465033|NCT01568112|144452639|SUPERIORITY_OR_OTHER||Mean difference|-1.0|STANDARD_ERROR_OF_MEAN|0.57|||TWO_SIDED|95.0|-2.2|0.1|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Tingling events||0.1|-2.2|
72465034|NCT01568112|144452639|SUPERIORITY_OR_OTHER||Mean difference|-1.1|STANDARD_ERROR_OF_MEAN|0.54|||TWO_SIDED|95.0|-2.2|0.0|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Tingling events||-0.0|-2.2|
72465035|NCT01568112|144452639|SUPERIORITY_OR_OTHER||Mean difference|-0.8|STANDARD_ERROR_OF_MEAN|0.61|||TWO_SIDED|95.0|-2.1|0.4|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Itching events||0.4|-2.1|
72465036|NCT01568112|144452639|SUPERIORITY_OR_OTHER||Mean difference|-1.3|STANDARD_ERROR_OF_MEAN|0.58|||TWO_SIDED|95.0|-2.4|-0.1|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Itching events||-0.1|-2.4|
72465037|NCT01568112|144452640|SUPERIORITY_OR_OTHER||Difference in percentage|-12.0|||||TWO_SIDED|95.0|-32.2|9.5|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Overall flushing events||9.5|-32.2|
72465038|NCT01568112|144452640|SUPERIORITY_OR_OTHER||Difference in percentage|7.0|||||TWO_SIDED|95.0|-14.1|27.8|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Overall flushing events||27.8|-14.1|
72465039|NCT01568112|144452641|SUPERIORITY_OR_OTHER||Difference in percentage|-22.0|||||TWO_SIDED|95.0|-41.0|0.1|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|||0.1|-41.0|
72465040|NCT01568112|144452641|SUPERIORITY_OR_OTHER||Difference in percentage|7.0|||||TWO_SIDED|95.0|-14.1|27.8|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|||27.8|-14.1|
72465041|NCT01568112|144452642|SUPERIORITY_OR_OTHER||Difference in percentage|-20.0|||||TWO_SIDED|95.0|-40.6|3.8|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|||3.8|-40.6|
72465042|NCT01568112|144452642|SUPERIORITY_OR_OTHER||Difference in percentage|-2.0|||||TWO_SIDED|95.0|-24.7|21.7|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|||21.7|-24.7|
72465043|NCT01568112|144452643|SUPERIORITY_OR_OTHER||Difference in percentage|0.0|||||TWO_SIDED|95.0|-22.0|22.0|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|||22.0|-22.0|
72465044|NCT01568112|144452643|SUPERIORITY_OR_OTHER||Difference in percentage|4.0|||||TWO_SIDED|95.0|-16.4|25.5|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|||25.5|-16.4|
72465045|NCT01568112|144452644|SUPERIORITY_OR_OTHER||Difference in percentage|-2.0|||||TWO_SIDED|95.0|-24.2|19.7|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|||19.7|-24.2|
72465046|NCT01568112|144452644|SUPERIORITY_OR_OTHER||Difference in percentage|-3.0|||||TWO_SIDED|95.0|-23.3|18.7|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|||18.7|-23.3|
72502577|NCT00756002|144535832|SUPERIORITY_OR_OTHER|||||||0.04||95.0||||P-values for differences are obtained using t-tests from the ANCOVA model of the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from an ANCOVA model with effects for treatment and pooled center, with Baseline as a covariate.||||||0.040
72502578|NCT00756002|144535833|SUPERIORITY_OR_OTHER|||||||0.814||95.0||||P-values for differences are obtained using t-tests from the ANCOVA model of the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from an ANCOVA model with effects for treatment and pooled center, with Baseline as a covariate.||||||0.814
72502579|NCT00756002|144535834|SUPERIORITY_OR_OTHER|||||||0.929||95.0||||P-values for differences are obtained using t-tests from the ANCOVA model of the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from an ANCOVA model with effects for treatment and pooled center, with Baseline as a covariate.||||||0.929
72502580|NCT00756002|144535835|SUPERIORITY_OR_OTHER|||||||0.591||95.0||||P-values for differences are obtained using t-tests from the ANCOVA model of the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from an ANCOVA model with effects for treatment and pooled center, with Baseline as a covariate.||||||0.591
72465047|NCT01568112|144452645|SUPERIORITY_OR_OTHER||Difference in percentage|-7.0|||||TWO_SIDED|95.0|-29.4|17.1|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|||17.1|-29.4|
72502581|NCT00756002|144535836|SUPERIORITY_OR_OTHER|||||||0.015||95.0||||P-values for differences are obtained using t-tests from the ANCOVA model of the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from an ANCOVA model with effects for treatment and pooled center, with Baseline as a covariate.||||||0.015
72502582|NCT00756002|144535837|SUPERIORITY_OR_OTHER|||||||0.097||95.0||||P-values for differences are obtained using t-tests from the ANCOVA model of the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from an ANCOVA model with effects for treatment and pooled center, with Baseline as a covariate.||||||0.097
72502583|NCT00756002|144535838|SUPERIORITY_OR_OTHER|||||||0.028||95.0||||P-values for differences are obtained using t-tests from the ANCOVA model of the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from an ANCOVA model with effects for treatment and pooled center, with Baseline as a covariate.||||||0.028
72465048|NCT01568112|144452645|SUPERIORITY_OR_OTHER||Difference in percentage|1.0|||||TWO_SIDED|95.0|-22.1|24.5|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|||24.5|-22.1|
72465049|NCT01568112|144452646|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.53|||TWO_SIDED|95.0|-1.1|1.1|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Nausea||1.1|-1.1|
72465050|NCT01568112|144452646|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.49|||TWO_SIDED|95.0|-1.1|0.9|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Nausea||0.9|-1.1|
72465051|NCT01568112|144452646|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.57|||TWO_SIDED|95.0|-1.4|0.8|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Diarrhea||0.8|-1.4|
72465052|NCT01568112|144452646|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8|STANDARD_ERROR_OF_MEAN|0.46|||TWO_SIDED|95.0|-1.7|0.1|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Diarrhea||0.1|-1.7|
72502584|NCT00756002|144535839|SUPERIORITY_OR_OTHER|||||||0.003||95.0||||P-values for differences are obtained using t-tests from the ANCOVA model of the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from an ANCOVA model with effects for treatment and pooled center, with Baseline as a covariate.||||||0.003
72502585|NCT00756002|144535840|SUPERIORITY_OR_OTHER|||||||0.111||95.0||||P-values for differences are obtained using t-tests from the ANCOVA model of the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from an ANCOVA model with effects for treatment and pooled center, with Baseline as a covariate.||||||0.111
72502586|NCT04899271|144535867|SUPERIORITY|||||||0.807|||||||Chi-squared|||||||0.807
72502587|NCT04899271|144535868|SUPERIORITY|||||||0.746|||||||Chi-squared|||Comparison at month 6||||0.746
72502588|NCT04899271|144535868|SUPERIORITY|||||||0.201|||||||Chi-squared|||Comparison at month 18||||0.201
72502589|NCT04899271|144535869|SUPERIORITY|||||||0.867|||||||Chi-squared|||Comparison at month 6||||0.867
72502590|NCT04899271|144535869|SUPERIORITY|||||||0.769|||||||Chi-squared|||Comparison at month 12||||0.769
72465053|NCT01568112|144452646|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.6|STANDARD_ERROR_OF_MEAN|0.53|||TWO_SIDED|95.0|-0.5|1.6|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Upper abdominal pain||1.6|-0.5|
72465054|NCT01568112|144452646|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.3|STANDARD_ERROR_OF_MEAN|0.5|||TWO_SIDED|95.0|-0.7|1.3|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Upper abdominal pain||1.3|-0.7|
72465055|NCT01568112|144452646|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.48|||TWO_SIDED|95.0|-1.0|0.9|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Lower abdominal pain||0.9|-1.0|
72465056|NCT01568112|144452646|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.46|||TWO_SIDED|95.0|-1.1|0.8|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Lower abdominal pain||0.8|-1.1|
72502591|NCT04899271|144535869|SUPERIORITY|||||||0.776|||||||Chi-squared|||Comparison at month 18||||0.776
72502592|NCT04899271|144535870|SUPERIORITY|||||||0.521||||||Assumption of normality was confirmed by Kolmogorov-Smirnov test; the comparison between treatment arms was performed by means of two-sample t-test.|t-test, 2 sided|||Comparison at month 6 for change from baseline||||0.521
72502593|NCT04899271|144535870|SUPERIORITY|||||||0.959||||||Assumption of normality was confirmed by Kolmogorov-Smirnov test; the comparison between treatment arms was performed by means of two-sample t-test.|t-test, 2 sided|||Comparison at month 12 for change from baseline||||0.959
72502594|NCT04899271|144535870|SUPERIORITY|||||||0.773||||||Assumption of normality was confirmed by Kolmogorov-Smirnov test; the comparison between treatment arms was performed by means of two-sample t-test.|t-test, 2 sided|||Comparison at month 18 for change from baseline||||0.773
72502595|NCT04899271|144535871|SUPERIORITY|||||||0.691|||||||t-test, 2 sided|Assumption of normality is confirmed by Kolmogorov-Smirnov test; comparison between treatment arms is performed by means of two-sample t-test.||Comparison at month 6 for change from baseline||||0.691
72502596|NCT04899271|144535871|SUPERIORITY|||||||0.685||||||Assumption of normality is confirmed by Kolmogorov-Smirnov test; comparison between treatment arms is performed by means of two-sample t-test.|t-test, 2 sided|||Comparison at month 12 for change from baseline||||0.685
72465057|NCT01568112|144452646|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.32|||TWO_SIDED|95.0|-0.6|0.7|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Vomiting||0.7|-0.6|
72465058|NCT01568112|144452646|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.26|||TWO_SIDED|95.0|-0.6|0.5|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Vomiting||0.5|-0.6|
72465059|NCT01568112|144452646|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.34|||TWO_SIDED|95.0|-1.0|0.3|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Indigestion||0.3|-1.0|
72465060|NCT01568112|144452646|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.41|||TWO_SIDED|95.0|-0.8|0.8|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Indigestion||0.8|-0.8|
72564076|NCT01115855|144659711|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|3.85|STANDARD_ERROR_OF_MEAN|1.94|||TWO_SIDED|95.0|0.02|7.68||||||Change from baseline at Month 37 : Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||7.68|0.02|
72465061|NCT01568112|144452646|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.41|||TWO_SIDED|95.0|-1.0|0.6|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Constipation||0.6|-1.0|
72465062|NCT01568112|144452646|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.44|||TWO_SIDED|95.0|-0.8|0.9|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Constipation||0.9|-0.8|
72465063|NCT01568112|144452646|SUPERIORITY_OR_OTHER||Difference in percentage|0.2|STANDARD_ERROR_OF_MEAN|0.4|||TWO_SIDED|95.0|-0.7|1.1||||||Bloating||1.1|-0.7|
72465064|NCT01568112|144452646|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.42|||TWO_SIDED|95.0|-0.9|0.7|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Bloating||0.7|-0.9|
72465065|NCT01568112|144452646|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.41|||TWO_SIDED|95.0|-0.8|0.9|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Flatulence||0.9|-0.8|
72465066|NCT01568112|144452646|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.2|STANDARD_ERROR_OF_MEAN|0.46|||TWO_SIDED|95.0|-0.7|1.1|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Flatulence||1.1|-0.7|
72465067|NCT01568112|144452647|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.44|||TWO_SIDED|95.0|-1.0|0.8|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Nausea||0.8|-1.0|
72465068|NCT01568112|144452647|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.41|||TWO_SIDED|95.0|-0.8|0.8|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Nausea||0.8|-0.8|
72564077|NCT01115855|144659711|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|4.67|STANDARD_ERROR_OF_MEAN|2.31|||TWO_SIDED|90.0|0.08|9.25||||||Change from baseline at Month 42 : Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||9.25|0.08|
72564078|NCT01115855|144659711|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|4.13|STANDARD_ERROR_OF_MEAN|2.98|||TWO_SIDED|95.0|-1.82|10.07||||||Change from baseline at Month 48 : Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||10.07|-1.82|
72465069|NCT01568112|144452647|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|0.52|||TWO_SIDED|95.0|-1.7|0.4|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Diarrhea||0.4|-1.7|
72465070|NCT01568112|144452647|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|0.46|||TWO_SIDED|95.0|-1.7|0.2|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Diarrhea||0.2|-1.7|
72465071|NCT01568112|144452647|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.32|||TWO_SIDED|95.0|-0.7|0.6|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Upper abdominal pain||0.6|-0.7|
72465072|NCT01568112|144452647|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.1|STANDARD_ERROR_OF_MEAN|0.37|||TWO_SIDED|95.0|-0.7|0.8|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Upper abdominal pain||0.8|-0.7|
72465073|NCT01568112|144452647|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.33|||TWO_SIDED|95.0|-0.6|0.7|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Lower abdominal pain||0.7|-0.6|
72465074|NCT01568112|144452647|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.5|STANDARD_ERROR_OF_MEAN|0.38|||TWO_SIDED|95.0|-0.2|1.3|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Lower abdominal pain||1.3|-0.2|
72465075|NCT01568112|144452647|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.19|||TWO_SIDED|95.0|-0.4|0.4|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Vomiting||0.4|-0.4|
72465076|NCT01568112|144452647|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|-0.4|0.2|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Vomiting||0.2|-0.4|
72465077|NCT01568112|144452647|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.32|||TWO_SIDED|95.0|-0.6|0.6|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Indigestion||0.6|-0.6|
72465078|NCT01568112|144452647|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.29|||TWO_SIDED|95.0|-0.7|0.5|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Indigestion||0.5|-0.7|
72465079|NCT01568112|144452647|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.4|STANDARD_ERROR_OF_MEAN|0.28|||TWO_SIDED|95.0|-0.1|1.0|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Constipation||1.0|-0.1|
72465080|NCT01568112|144452647|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|0.2|||TWO_SIDED|95.0|-0.2|0.6|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Constipation||0.6|-0.2|
72465081|NCT01568112|144452647|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.37|||TWO_SIDED|95.0|-0.8|0.7|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Bloating||0.7|-0.8|
72465082|NCT01568112|144452647|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|0.38|||TWO_SIDED|95.0|-0.7|0.8|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Bloating||0.8|-0.7|
72465083|NCT01568112|144452647|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8|STANDARD_ERROR_OF_MEAN|0.38|||TWO_SIDED|95.0|-1.6|0.0|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Flatulence||-0.0|-1.6|
72465084|NCT01568112|144452647|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.44|||TWO_SIDED|95.0|-1.2|0.5|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Flatulence||0.5|-1.2|
72465085|NCT01568112|144452648|SUPERIORITY_OR_OTHER||Difference in percentage|9.0|||||TWO_SIDED|95.0|-11.8|30.0|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|||30.0|-11.8|
72465086|NCT01568112|144452648|SUPERIORITY_OR_OTHER||Difference in percentage|9.0|||||TWO_SIDED|95.0|-11.8|30.0|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|||30.0|-11.8|
72502597|NCT04899271|144535871|SUPERIORITY|||||||0.64||||||Assumption of normality is not confirmed by Kolmogorov-Smirnov test; comparison between treatment arms is performed by means of two-sample Mann-Whitney U test|Wilcoxon (Mann-Whitney)|||Comparison at month 18 for change from baseline||||0.640
72465087|NCT01568112|144452649|SUPERIORITY_OR_OTHER||Difference in percentage|2.0|||||TWO_SIDED|95.0|-18.8|23.3|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|||23.3|-18.8|
72465088|NCT01568112|144452649|SUPERIORITY_OR_OTHER||Difference in percentage|6.0|||||TWO_SIDED|95.0|-14.1|27.8|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|||27.8|-14.1|
72465089|NCT01568112|144452650|SUPERIORITY_OR_OTHER||Difference in percentage|-9.0|||||TWO_SIDED|95.0|-32.1|14.3|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|||14.3|-32.1|
72502598|NCT04899271|144535872|SUPERIORITY|||||||0.867||||||Comparison between treatment arms is performed by means of a Chi-squared test|Chi-squared|||Comparison at month 6||||0.867
72564079|NCT01115855|144659711|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|3.18|STANDARD_ERROR_OF_MEAN|1.33|||TWO_SIDED|95.0|0.56|5.8||||||Change from baseline at Month 13 : ANCOVA with treatment effect and covariates of the NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||5.80|0.56|
72564080|NCT01115855|144659712|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-61.53|STANDARD_ERROR_OF_MEAN|59.75|||TWO_SIDED|95.0|-186.44|63.37||||||Change from baseline at Month 5: Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||63.37|-186.44|
72564081|NCT01115855|144659712|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-24.94|STANDARD_ERROR_OF_MEAN|54.2|||TWO_SIDED|95.0|-131.27|81.39||||||Change from baseline at Month 9 : Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||81.39|-131.27|
72465090|NCT01568112|144452650|SUPERIORITY_OR_OTHER||Difference in percentage|-2.0|||||TWO_SIDED|95.0|-25.0|21.7|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|||21.7|-25.0|
72465091|NCT01568112|144452657|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.6|STANDARD_ERROR_OF_MEAN|13.79|||TWO_SIDED|95.0|-20.9|34.1|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|||34.1|-20.9|
72502599|NCT04899271|144535872|SUPERIORITY|||||||0.769||||||Comparison between treatment arms is performed by means of a Chi-squared test|Chi-squared|Comparison between treatment arms is performed by means of a Chi-squared and Fisher's Exact test separated with a /.||Comparison at month 12||||0.769
72502600|NCT04899271|144535872|SUPERIORITY|||||||0.577|||||||Chi-squared|Comparison between treatment arms is performed by means of a Chi-squared test.||Comparison at month 18||||0.577
72465092|NCT01568112|144452657|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.8|STANDARD_ERROR_OF_MEAN|10.03|||TWO_SIDED|95.0|-14.2|25.7|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|||25.7|-14.2|
72465093|NCT01568112|144452658|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|22.2|STANDARD_ERROR_OF_MEAN|24.4|||TWO_SIDED|95.0|-26.5|70.9|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|||70.9|-26.5|
72502601|NCT04899271|144535873|SUPERIORITY|The effect of treatment on the cumulative number of severe hypoglycemic events was evaluated by means of a Cox proportional hazards model. The Andersen-Gill intensity model with model-based variance was utilized.|Hazard Ratio (HR)|1.271||||0.554|TWO_SIDED|95.0|0.573|2.819|||Cox proportional hazards model|Analysis is based on Cox proportional hazards model.||||2.819|0.573|0.554
72465094|NCT01568112|144452658|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.6|STANDARD_ERROR_OF_MEAN|11.08|||TWO_SIDED|95.0|-20.5|23.6|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|||23.6|-20.5|
72465095|NCT01568112|144452659|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|17.5|STANDARD_ERROR_OF_MEAN|13.32|||TWO_SIDED|95.0|-9.2|44.2|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|||44.2|-9.2|
72465096|NCT01568112|144452659|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.4|STANDARD_ERROR_OF_MEAN|8.8|||TWO_SIDED|95.0|-17.2|18.0|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|||18.0|-17.2|
72465097|NCT01568112|144452660|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.96|STANDARD_ERROR_OF_MEAN|4.601|||TWO_SIDED|95.0|-6.34|12.26|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Nausea||12.26|-6.34|
72465098|NCT01568112|144452660|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.07|STANDARD_ERROR_OF_MEAN|2.347|||TWO_SIDED|95.0|-8.81|0.67|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Nausea||0.67|-8.81|
72465099|NCT01568112|144452660|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.74|STANDARD_ERROR_OF_MEAN|7.335|||TWO_SIDED|95.0|-3.15|26.63|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Diarrhea||26.63|-3.15|
72502602|NCT04899271|144535875|SUPERIORITY|||||||0.32||||||Assumption of normality is not confirmed by Kolmogorov-Smirnov test; comparison between treatment arms is performed by means of two-sample Mann-Whitney U test.|Wilcoxon (Mann-Whitney)|||Comparison at month 6 for change from baseline||||0.320
72502603|NCT04899271|144535875|SUPERIORITY|||||||0.398||||||Assumption of normality is not confirmed by Kolmogorov-Smirnov test; comparison between treatment arms is performed by means of two-sample Mann-Whitney U test.|Wilcoxon (Mann-Whitney)|||Comparison at month 12 for change from baseline||||0.398
72465100|NCT01568112|144452660|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.05|STANDARD_ERROR_OF_MEAN|2.321|||TWO_SIDED|95.0|-2.67|6.77|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Diarrhea||6.77|-2.67|
72465101|NCT01568112|144452660|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.21|STANDARD_ERROR_OF_MEAN|7.812|||TWO_SIDED|95.0|-6.72|25.14|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Upper abdominal pain||25.14|-6.72|
72465102|NCT01568112|144452660|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.84|STANDARD_ERROR_OF_MEAN|4.152|||TWO_SIDED|95.0|-11.31|5.63|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Upper abdominal pain||5.63|-11.31|
72465103|NCT01568112|144452660|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.09|STANDARD_ERROR_OF_MEAN|7.516|||TWO_SIDED|95.0|-18.36|12.19|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Lower abdominal pain||12.19|-18.36|
72465104|NCT01568112|144452660|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.18|STANDARD_ERROR_OF_MEAN|7.141|||TWO_SIDED|95.0|-20.71|8.35|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Lower abdominal pain||8.35|-20.71|
72465105|NCT01568112|144452660|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.21|STANDARD_ERROR_OF_MEAN|5.292|||TWO_SIDED|95.0|-22.9|6.49|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Vomiting||6.49|-22.90|
72465106|NCT01568112|144452660|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.33|STANDARD_ERROR_OF_MEAN|6.536|||TWO_SIDED|95.0|-30.13|11.47|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Vomiting||11.47|-30.13|
72465107|NCT01568112|144452660|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.69|STANDARD_ERROR_OF_MEAN|8.376|||TWO_SIDED|95.0|-30.02|4.63|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Indigestion||4.63|-30.02|
72465108|NCT01568112|144452660|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.58|STANDARD_ERROR_OF_MEAN|8.654|||TWO_SIDED|95.0|-29.48|6.32|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Indigestion||6.32|-29.48|
72465109|NCT01568112|144452660|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.93|STANDARD_ERROR_OF_MEAN|10.274|||TWO_SIDED|95.0|-35.44|7.57|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Constipation||7.57|-35.44|
72465110|NCT01568112|144452660|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.29|STANDARD_ERROR_OF_MEAN|12.369|||TWO_SIDED|95.0|-33.39|18.81|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Constipation||18.81|-33.39|
72465111|NCT01568112|144452660|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.24|STANDARD_ERROR_OF_MEAN|6.472|||TWO_SIDED|95.0|-20.4|5.93|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Bloating||5.93|-20.40|
72465112|NCT01568112|144452660|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|60.33|STANDARD_ERROR_OF_MEAN|34.455|||TWO_SIDED|95.0|-10.78|131.4|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Bloating||131.4|-10.78|
72465113|NCT01568112|144452660|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|59.87|STANDARD_ERROR_OF_MEAN|65.007|||TWO_SIDED|95.0|-71.51|191.2|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Flatulence||191.2|-71.51|
72465114|NCT01568112|144452660|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|54.78|STANDARD_ERROR_OF_MEAN|40.44|||TWO_SIDED|95.0|-27.09|136.6|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Flatulence||136.6|-27.09|
72465115|NCT01568112|144452661|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.95|STANDARD_ERROR_OF_MEAN|5.281|||TWO_SIDED|95.0|-6.79|14.68|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Nausea||14.68|-6.79|
72465116|NCT01568112|144452661|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.37|STANDARD_ERROR_OF_MEAN|2.563|||TWO_SIDED|95.0|-9.57|0.83|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Nausea||0.83|-9.57|
72465117|NCT01568112|144452661|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.51|STANDARD_ERROR_OF_MEAN|8.024|||TWO_SIDED|95.0|-2.84|29.86|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Diarrhea||29.86|-2.84|
72465118|NCT01568112|144452661|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.44|STANDARD_ERROR_OF_MEAN|2.379|||TWO_SIDED|95.0|-2.41|7.29|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Diarrhea||7.29|-2.41|
72465119|NCT01568112|144452661|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.84|STANDARD_ERROR_OF_MEAN|8.143|||TWO_SIDED|95.0|-5.81|27.5|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Upper abdominal pain||27.50|-5.81|
72465120|NCT01568112|144452661|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.5|STANDARD_ERROR_OF_MEAN|4.671|||TWO_SIDED|95.0|-12.08|7.09|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Upper abdominal pain||7.09|-12.08|
72465121|NCT01568112|144452661|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.69|STANDARD_ERROR_OF_MEAN|8.488|||TWO_SIDED|95.0|-19.03|15.64|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Lower abdominal pain||15.64|-19.03|
72465122|NCT01568112|144452661|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.91|STANDARD_ERROR_OF_MEAN|7.832|||TWO_SIDED|95.0|-23.93|8.11|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Lower abdominal pain||8.11|-23.93|
72465123|NCT01568112|144452661|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.1|STANDARD_ERROR_OF_MEAN|4.811|||TWO_SIDED|95.0|-23.8|17.6|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Vomiting||17.60|-23.80|
72465124|NCT01568112|144452661|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.88|STANDARD_ERROR_OF_MEAN|4.155|||TWO_SIDED|95.0|-22.75|13.0|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Vomiting||13.00|-22.75|
72465125|NCT01568112|144452661|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-25.08|STANDARD_ERROR_OF_MEAN|16.243|||TWO_SIDED|95.0|-59.2|9.05|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Indigestion||9.05|-59.20|
72465126|NCT01568112|144452661|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-23.95|STANDARD_ERROR_OF_MEAN|14.83|||TWO_SIDED|95.0|-54.89|6.98|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Indigestion||6.98|-54.89|
72465127|NCT01568112|144452661|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.49|STANDARD_ERROR_OF_MEAN|10.847|||TWO_SIDED|95.0|-35.38|10.39|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Constipation||10.39|-35.38|
72465128|NCT01568112|144452661|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.33|STANDARD_ERROR_OF_MEAN|12.542|||TWO_SIDED|95.0|-32.79|20.13|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Constipation||20.13|-32.79|
72465129|NCT01568112|144452661|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.73|STANDARD_ERROR_OF_MEAN|6.442|||TWO_SIDED|95.0|-15.87|10.41|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Bloating||10.41|-15.87|
72465130|NCT01568112|144452661|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|81.89|STANDARD_ERROR_OF_MEAN|50.239|||TWO_SIDED|95.0|-22.04|185.8|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Bloating||185.8|-22.04|
72465131|NCT01568112|144452661|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|26.52|STANDARD_ERROR_OF_MEAN|32.896|||TWO_SIDED|95.0|-40.13|93.18|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Flatulence||93.18|-40.13|
72465132|NCT01568112|144452661|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|51.78|STANDARD_ERROR_OF_MEAN|41.055|||TWO_SIDED|95.0|-31.65|135.2|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Flatulence||135.2|-31.65|
72465133|NCT01568112|144452662|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.68|STANDARD_ERROR_OF_MEAN|2.626|||TWO_SIDED|95.0|-7.35|3.99|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Nausea||3.99|-7.35|
72465134|NCT01568112|144452662|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.0|STANDARD_ERROR_OF_MEAN|2.18|||TWO_SIDED|95.0|-6.62|2.62|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Nausea||2.62|-6.62|
72465135|NCT01568112|144452662|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.43|STANDARD_ERROR_OF_MEAN|5.717|||TWO_SIDED|95.0|-11.64|12.49|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Diarrhea||12.49|-11.64|
72465136|NCT01568112|144452662|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.48|STANDARD_ERROR_OF_MEAN|4.597|||TWO_SIDED|95.0|-14.11|5.14||||||Diarrhea||5.14|-14.11|
72465137|NCT01568112|144452662|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.74|STANDARD_ERROR_OF_MEAN|0.794|||TWO_SIDED|95.0|-1.1|2.57|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Upper abdominal pain||2.57|-1.10|
72465138|NCT01568112|144452662|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.61|STANDARD_ERROR_OF_MEAN|0.775|||TWO_SIDED|95.0|-1.17|2.4|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Upper abdominal pain||2.40|-1.17|
72465139|NCT01568112|144452662|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.14|STANDARD_ERROR_OF_MEAN|1.705|||TWO_SIDED|95.0|-5.08|2.79|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Lower abdominal pain||2.79|-5.08|
72465140|NCT01568112|144452662|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|18.56|STANDARD_ERROR_OF_MEAN|27.886|||TWO_SIDED|95.0|-42.19|79.32|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Lower abdominal pain||79.32|-42.19|
72465141|NCT01568112|144452662|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.46|STANDARD_ERROR_OF_MEAN|2.801|||TWO_SIDED|95.0|-3.65|8.56|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Indigestion||8.56|-3.65|
72465142|NCT01568112|144452662|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.94|STANDARD_ERROR_OF_MEAN|1.242|||TWO_SIDED|95.0|-3.71|1.83|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Indigestion||1.83|-3.71|
72465143|NCT01568112|144452662|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.83|STANDARD_ERROR_OF_MEAN|19.649|||TWO_SIDED|95.0|-48.73|60.38|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Constipation||60.38|-48.73|
72465144|NCT01568112|144452662|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.76|STANDARD_ERROR_OF_MEAN|11.219|||TWO_SIDED|95.0|-28.38|33.91|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Constipation||33.91|-28.38|
72465145|NCT01568112|144452662|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.36|STANDARD_ERROR_OF_MEAN|9.811|||TWO_SIDED|95.0|-35.56|6.83|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Bloating||6.83|-35.56|
72465146|NCT01568112|144452662|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|67.12|STANDARD_ERROR_OF_MEAN|41.961|||TWO_SIDED|95.0|-22.88|157.1|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Bloating||157.1|-22.88|
72465147|NCT01568112|144452662|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|98.65|STANDARD_ERROR_OF_MEAN|74.566|||TWO_SIDED|95.0|-58.01|255.3|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Flatulence||255.3|-58.01|
72465148|NCT01568112|144452662|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.27|STANDARD_ERROR_OF_MEAN|7.928|||TWO_SIDED|95.0|-5.22|27.76|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Flatulence||27.76|-5.22|
72465149|NCT01644188|144452720|SUPERIORITY_OR_OTHER||LS Mean Difference|-29.8|||<|0.0001|TWO_SIDED|95.0|-34.4|-25.3||Threshold for significance ≤0.05.|Mixed Models Analysis||Alirocumab vs. ezetimibe|Alirocumab group was compared to ezetimibe group using an appropriate contrast statement.||-25.3|-34.4|<0.0001
72465150|NCT01644188|144452721|SUPERIORITY_OR_OTHER||LS Mean Difference|-30.6|||<|0.0001|TWO_SIDED|95.0|-34.9|-26.2||Threshold for significance ≤0.05|Mixed Models Analysis||Alirocumab vs. ezetimibe|A hierarchical testing procedure was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when previous endpoint was statistically significant at 0.05 level.||-26.2|-34.9|<0.0001
72465151|NCT01644188|144452722|SUPERIORITY_OR_OTHER||LS Mean Difference|-29.4|||<|0.0001|TWO_SIDED|95.0|-33.7|-25.1||Threshold for significance ≤0.05.|Mixed Models Analysis||Alirocumab vs. ezetimibe|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-25.1|-33.7|<0.0001
72465152|NCT01644188|144452723|SUPERIORITY_OR_OTHER||LS Mean Difference|-29.7|||<|0.0001|TWO_SIDED|95.0|-33.8|-25.6||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. ezetimibe|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-25.6|-33.8|<0.0001
72564082|NCT01115855|144659712|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-12.57|STANDARD_ERROR_OF_MEAN|43.18|||TWO_SIDED|95.0|-97.28|72.13||||||Change from baseline at Month 13 :Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||72.13|-97.28|
72564083|NCT01115855|144659712|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-78.47|STANDARD_ERROR_OF_MEAN|72.78|||TWO_SIDED|95.0|-221.25|64.31||||||Change from baseline at Month 17 :Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||64.31|-221.25|
72564084|NCT01115855|144659712|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-79.63|STANDARD_ERROR_OF_MEAN|67.42|||TWO_SIDED|95.0|-211.88|52.63||||||Change from baseline at Month 21 : Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||52.63|-211.88|
72465153|NCT01644188|144452724|SUPERIORITY_OR_OTHER||LS Mean Difference|-22.4|||<|0.0001|TWO_SIDED|95.0|-26.0|-18.8||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. ezetimibe|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-18.8|-26|<0.0001
72465154|NCT01644188|144452725|SUPERIORITY_OR_OTHER||LS Mean Difference|-23.0|||<|0.0001|TWO_SIDED|95.0|-26.5|-19.6||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. ezetimibe|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-19.6|-26.5|<0.0001
72465155|NCT01644188|144452726|SUPERIORITY_OR_OTHER||LS Mean Difference|-22.9|||<|0.0001|TWO_SIDED|95.0|-26.9|-18.9||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. ezetimibe|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-18.9|-26.9|<0.0001
72465156|NCT01644188|144452727|SUPERIORITY_OR_OTHER||LS Mean Difference|-23.5|||<|0.0001|TWO_SIDED|95.0|-27.2|-19.7||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. ezetimibe|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-19.7|-27.2|<0.0001
72465157|NCT01644188|144452728|SUPERIORITY_OR_OTHER||LS Mean Difference|-14.7|||<|0.0001|TWO_SIDED|95.0|-17.7|-11.7||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. ezetimibe|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-11.7|-17.7|<0.0001
72465158|NCT01644188|144452729|SUPERIORITY_OR_OTHER||LS Mean Difference|-22.5|||<|0.0001|TWO_SIDED|95.0|-25.7|-19.2||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. ezetimibe|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-19.2|-25.7|<0.0001
72465159|NCT01644188|144452730|SUPERIORITY_OR_OTHER||LS Mean Difference|-22.0|||<|0.0001|TWO_SIDED|95.0|-25.6|-18.3||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. ezetimibe|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-18.3|-25.6|<0.0001
72465160|NCT01644188|144452731|SUPERIORITY_OR_OTHER||LS Mean Difference|-14.3|||<|0.0001|TWO_SIDED|95.0|-17.1|-11.6||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. ezetimibe|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-11.6|-17.1|<0.0001
72465161|NCT01644188|144452732|SUPERIORITY_OR_OTHER||LS Mean Difference|-31.2|||<|0.0001|TWO_SIDED|95.0|-36.3|-26.1||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. ezetimibe|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-26.1|-36.3|<0.0001
72465162|NCT01644188|144452733|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.4|||<|0.0001|TWO_SIDED|95.0|3.7|7.9||Threshold for significance ≤ 0.05.|Regression, Logistic|Multiple imputation approach followed by Logistic regression model.|Alirocumab vs. ezetimibe|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||7.9|3.7|<0.0001
72465163|NCT01644188|144452734|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.9|||<|0.0001|TWO_SIDED|95.0|3.9|8.8||Threshold for significance ≤ 0.05.|Regression, Logistic|Multiple imputation approach followed by logistic regression model|Alirocumab vs. ezetimibe|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||8.8|3.9|<0.0001
72465164|NCT01644188|144452735|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-21.7|||<|0.0001|TWO_SIDED|95.0|-26.4|-17.0||Threshold for significance ≤ 0.05.|Regression, Robust|Multiple imputation approach followed by robust regression model.|Alirocumab vs. ezetimibe|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-17|-26.4|<0.0001
72465165|NCT01644188|144452736|SUPERIORITY_OR_OTHER||LS Mean Difference|8.1|||<|0.0001|TWO_SIDED|95.0|5.4|10.7||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. ezetimibe|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||10.7|5.4|<0.0001
72465166|NCT01644188|144452737|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.3||||0.9117|TWO_SIDED|95.0|-5.1|4.6||Threshold for significance ≤ 0.05.|Regression, Robust|Multiple imputation approach followed by robust regression.|Alirocumab vs. ezetimibe|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||4.6|-5.1|0.9117
72465167|NCT03119688|144452746|NON_INFERIORITY|The non-Inferiority margin is set at 0.25. The upper limit of the 90% CI is less than this and hence NI is met.|Mean Difference (Net)|-0.077||||0.1769|TWO_SIDED|90.0|-0.1707|0.0169||No adjustment for multiple comparisons was made.|ANOVA|ANOVA model with change from baseline in examiner assessment on dryness as response and treatment, site as fixed effects; participant as random effect|Difference is first named treatment minus second named treatment such that a negative difference favors first named treatment.|The null hypothesis (non-inferiority setting) is that the population mean dryness for Test minus Baxter Sterile Water (negative control) is at least 0.25.||0.0169|-0.1707|0.1769
72465168|NCT03119688|144452746|SUPERIORITY|This is a superiority test setting.|Mean Difference (Net)|0.35|||<|0.0001|TWO_SIDED|90.0|0.2565|0.4441||No adjustment for multiple comparisons was made.|ANOVA|ANOVA model with change from baseline in examiner assessment on dryness as response and treatment, site as fixed effects;participant as random effect|Difference is first named treatment minus second named treatment such that a negative difference favors first named treatment.|The null hypothesis is that the difference in population mean dryness is zero.||0.4441|0.2565|<.0001
72465169|NCT03119688|144452746|SUPERIORITY|This is a superiority test setting.|Mean Difference (Net)|0.427|||<|0.0001|TWO_SIDED|90.0|0.3333|0.5211||No adjustment for multiple comparisons was made.|ANOVA|ANOVA model with change from baseline in examiner assessment on dryness as response and treatment, site as fixed effects; participant as random effect|Difference is first named treatment minus second named treatment such that a negative difference favors first named treatment.|The null hypothesis is that the difference in population mean dryness is zero.||0.5211|0.3333|<.0001
72465170|NCT03119688|144452746|SUPERIORITY|This is a superiority test setting.|Mean Difference (Net)|0.065||||0.2518|TWO_SIDED|90.0|-0.0287|0.1592||No adjustment for multiple comparisons was made.|ANOVA|ANOVA model with change from baseline in examiner assessment on dryness as response and treatment, site as fixed effects;participant as random effect|Difference is first named treatment minus second named treatment such that a negative difference favors first named treatment.|The null hypothesis is that the difference in population mean dryness is zero.||0.1592|-0.0287|0.2518
72465171|NCT03226106|144452752|SUPERIORITY||Mean Difference (Final Values)|930.51||||0.024|TWO_SIDED|95.0|41.65|1819.36||The value corresponds to the interaction between time and group assignment.|Mixed Models Analysis|We used a linear mixed model with a random intercept for subject and fixed effects for age, time, and interaction between intervention arm and time.|The difference is the estimated mean between the intervention and control arms.|||1819.36|41.65|0.024
72465172|NCT03226106|144452753|SUPERIORITY||Mean Difference (Final Values)|0.7||||0.584|TWO_SIDED|95.0|-0.67|2.07||The value corresponds to the interaction between time and group assignment.|Mixed Models Analysis|We used a linear mixed model with a random intercept for subject and fixed effects for age, time, and interaction between intervention arm and time.|The difference is the estimated mean between the intervention and control arms.|||2.07|-0.67|0.584
72465173|NCT03226106|144452754|SUPERIORITY||Mean Difference (Final Values)|-0.04||||0.724|TWO_SIDED|95.0|-1.4|1.32||The value corresponds to the interaction between time and group assignment.|Mixed Models Analysis|We used a linear mixed model with a random intercept for subject and fixed effects for age, time, and interaction between intervention arm and time.|The difference is the estimated mean between the intervention and control arms.|||1.32|-1.40|0.724
72465174|NCT03226106|144452755|SUPERIORITY||Mean Difference (Final Values)|7.49||||0.547|TWO_SIDED|95.0|-18.9|33.89||The value corresponds to the interaction between time and group assignment.|Mixed Models Analysis|We used a linear mixed model with a random intercept for subject and fixed effects for age, time, and interaction between intervention arm and time.|The difference is the estimated mean between the intervention and control arms.|||33.89|-18.90|0.547
72465175|NCT03226106|144452756|SUPERIORITY||Mean Difference (Final Values)|4.93||||0.716|TWO_SIDED|95.0|-21.67|31.54||The value corresponds to the interaction between time and group assignment.|Mixed Models Analysis|We used a linear mixed model with a random intercept for subject and fixed effects for age, time, and interaction between intervention arm and time.|The difference is the estimated mean between the intervention and control arms.|||31.54|-21.67|0.716
72465176|NCT03226106|144452757|SUPERIORITY||Mean Difference (Final Values)|-0.03||||0.946|TWO_SIDED|95.0|-0.88|0.82||The value corresponds to the interaction between time and group assignment.|Mixed Models Analysis|We used a linear mixed model with a random intercept for subject and fixed effects for age, time, and interaction between intervention arm and time.|The difference is the estimated mean between the intervention and control arms.|||0.82|-0.88|0.946
72465177|NCT03226106|144452758|SUPERIORITY||Mean Difference (Final Values)|-0.28||||0.906|TWO_SIDED|95.0|-1.08|0.52||The value corresponds to the interaction between time and group assignment.|Mixed Models Analysis|We used a linear mixed model with a random intercept for subject and fixed effects for age, time, and interaction between intervention arm and time.|The difference is the estimated mean between the intervention and control arms.|||0.52|-1.08|0.906
72465178|NCT03226106|144452759|SUPERIORITY||Mean Difference (Final Values)|-1.55||||0.873|TWO_SIDED|95.0|-7.59|4.49||The value corresponds to the interaction between time and group assignment.|Mixed Models Analysis|We used a linear mixed model with a random intercept for subject and fixed effects for age, time, and interaction between intervention arm and time.|The difference is the estimated mean between the intervention and control arms.|||4.49|-7.59|0.873
72465179|NCT03226106|144452760|SUPERIORITY||Mean Difference (Final Values)|-6.26||||0.241|TWO_SIDED|95.0|-12.48|-0.04||The value corresponds to the interaction between time and group assignment.|Mixed Models Analysis|We used a linear mixed model with a random intercept for subject and fixed effects for age, time, and interaction between intervention arm and time.|The difference is the estimated mean between the intervention and control arms.|||-0.04|-12.48|0.241
72465180|NCT03226106|144452761|SUPERIORITY||Mean Difference (Final Values)|2.86||||0.223|TWO_SIDED|95.0|-0.39|6.12||The value corresponds to the interaction between time and group assignment.|Mixed Models Analysis|We used a linear mixed model with a random intercept for subject and fixed effects for age, time, and interaction between intervention arm and time.|The difference is the estimated mean between the intervention and control arms.|||6.12|-0.39|0.223
72465181|NCT03226106|144452762|SUPERIORITY||Mean Difference (Final Values)|1.17||||0.388|TWO_SIDED|95.0|-2.19|4.53||The value corresponds to the interaction between time and group assignment.|Mixed Models Analysis|We used a linear mixed model with a random intercept for subject and fixed effects for age, time, and interaction between intervention arm and time.|The difference is the estimated mean between the intervention and control arms.|||4.53|-2.19|0.388
72564085|NCT01115855|144659712|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|19.35|STANDARD_ERROR_OF_MEAN|88.95|||TWO_SIDED|95.0|-230.01|268.71||||||Change from baseline at Month 25 : Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||268.71|-230.01|
72465182|NCT03226106|144452763|SUPERIORITY||Mean Difference (Final Values)|-0.7||||0.88|TWO_SIDED|95.0|-4.08|2.68||The value corresponds to the interaction between time and group assignment.|Mixed Models Analysis|We used a linear mixed model with a random intercept for subject and fixed effects for age, time, and interaction between intervention arm and time.|The difference is the estimated mean between the intervention and control arms.|||2.68|-4.08|0.88
72465183|NCT03226106|144452764|SUPERIORITY||Mean Difference (Final Values)|0.77||||0.85|TWO_SIDED|95.0|-2.63|4.17||The value corresponds to the interaction between time and group assignment.|Mixed Models Analysis|We used a linear mixed model with a random intercept for subject and fixed effects for age, time, and interaction between intervention arm and time.|The difference is the estimated mean between the intervention and control arms.|||4.17|-2.63|0.85
72465184|NCT03226106|144452765|SUPERIORITY||Mean Difference (Final Values)|559.81||||0.101|TWO_SIDED|95.0|-405.01|1524.62||The value corresponds to the interaction between time and group assignment.|Mixed Models Analysis|We used a linear mixed model with a random intercept for subject and fixed effects for age, time, and interaction between intervention arm and time.|The difference is the estimated mean between the intervention and control arms.|||1524.62|-405.01|0.101
72465185|NCT01772823|144452807|OTHER|||||||0.7513||||||"The chi-squared test of homogeneity is used to assess whether the proportions of the independent variable (participant feelings on the Size of the Pill) differ between intervention arms."|Chi-squared|||||||0.7513
72465186|NCT01772823|144452808|OTHER|||||||0.8281||||||"The chi-squared test of homogeneity is used to assess whether the proportions of the independent variable (participant feelings on the Taste of the Pill) differ between intervention arms."|Chi-squared|Pearson Chi-Square||||||0.8281
72465187|NCT01772823|144452809|OTHER|||||||0.3761||||||"The chi-squared test of homogeneity is used to assess whether the proportions of the independent variable (participant feelings on the Color of the Pill) differ between intervention arms."|Chi-squared|||||||0.3761
72465188|NCT01772823|144452810|OTHER|||||||0.4359||||||"The chi-squared test of homogeneity is used to assess whether the proportions of the independent variable (participant feelings on Taking the pill every day) differ between intervention arms."|Chi-squared|||||||0.4359
72465189|NCT01772823|144452811|OTHER|||||||0.3801||||||"The chi-squared test of homogeneity is used to assess whether the proportions of the independent variable (participant feelings on Taking part in the study) differ between intervention arms."|Chi-squared|||||||0.3801
72465190|NCT01772823|144452812|OTHER|||||||0.1968||||||"The chi-squared test of homogeneity is used to assess whether the proportions of the independent variable (participant feelings on HIV test at every visit) differ between intervention arms."|Chi-squared|||||||0.1968
72465191|NCT01772823|144452813|OTHER|||||||0.1226||||||"The chi-squared test of homogeneity is used to assess whether the proportions of the independent variable (participant feelings on Risk Reduction counseling at every visit) differ between intervention arms."|Chi-squared|||||||0.1226
72465192|NCT01772823|144452814|OTHER|||||||0.0994||||||"The chi-squared test of homogeneity is used to assess whether the proportions of the independent variable (participant feelings on Questions about sexual behavior) differ between intervention arms."|Chi-squared|||||||0.0994
72465193|NCT01772823|144452815|OTHER|||||||0.5285||||||"The chi-squared test of homogeneity is used to assess whether the proportions of the independent variable (participant feelings on the Physician exam) differ between intervention arms."|Chi-squared|||||||0.5285
72465194|NCT01772823|144452819|OTHER|||||||0.0001||||||The chi-squared test of homogeneity is used to assess whether the proportions of the independent variable (participant responses to the session evaluation question) differ between intervention arms.|Chi-squared|||||||0.0001
72564086|NCT01115855|144659712|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-21.05|STANDARD_ERROR_OF_MEAN|88.27|||TWO_SIDED|95.0|-194.21|152.11||||||Change from baseline at Month 29: Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||152.11|-194.21|
72465195|NCT01772823|144452820|OTHER|||||||0.0098||||||The chi-squared test of homogeneity is used to assess whether the proportions of the independent variable (participant responses to the session evaluation question) differ between intervention arms.|Chi-squared|||||||0.0098
72465196|NCT01772823|144452821|OTHER|||||||0.0766||||||The chi-squared test of homogeneity is used to assess whether the proportions of the independent variable (participant responses to the session evaluation question) differ between intervention arms.|Chi-squared|||||||0.0766
72465197|NCT01772823|144452822|OTHER|||||||0.1581||||||The chi-squared test of homogeneity is used to assess whether the proportions of the independent variable (participant responses to the session evaluation question) differ between intervention arms.|Chi-squared|||||||0.1581
72465198|NCT01772823|144452823|OTHER|||||||0.43||||||The chi-squared test of homogeneity is used to assess whether the proportions of the independent variable (participant responses to the session evaluation question) differ between intervention arms.|Chi-squared|||||||0.4300
72465199|NCT01772823|144452824|OTHER|||||||0.1201||||||The chi-squared test of homogeneity is used to assess whether the proportions of the independent variable (participant responses to the session evaluation question) differ between intervention arms.|Chi-squared|||||||0.1201
72465200|NCT01772823|144452825|OTHER|||||||0.1682||||||The chi-squared test of homogeneity is used to assess whether the proportions of the independent variable (participant responses to the session evaluation question) differ between intervention arms.|Chi-squared|||||||0.1682
72465201|NCT01772823|144452826|OTHER|||||||0.2747||||||The chi-squared test of homogeneity is used to assess whether the proportions of the independent variable (participant responses to the session evaluation question) differ between intervention arms.|Chi-squared|||||||0.2747
72465202|NCT01772823|144452827|OTHER|||||||0.0046||||||The chi-squared test of homogeneity is used to assess whether the proportions of the independent variable (participant responses to the session evaluation question) differ between intervention arms.|Chi-squared|||||||0.0046
72465203|NCT01772823|144452828|OTHER|||||||0.029||||||The chi-squared test of homogeneity is used to assess whether the proportions of the independent variable (participant responses to the session evaluation question) differ between intervention arms.|Chi-squared|||||||0.0290
72465204|NCT01772823|144452829|OTHER|||||||0.107|||||||Kruskal-Wallis|||||||0.1070
72465205|NCT01772823|144452831|OTHER|||||||0.2991||||||The chi-squared test of homogeneity is used to assess whether the proportions of the independent variable (participant self-identified race) differ between groups (On PrEP vs. Off PrEP).|Fisher Exact|||||||0.2991
72465206|NCT01772823|144452832|OTHER|||||||0.0298||||||The chi-squared test of homogeneity is used to assess whether the proportions of the independent variable (participant self-identified race) differ between groups (On PrEP vs. Off PrEP).|Fisher Exact|||||||0.0298
72465207|NCT01772823|144452833|OTHER|||||||0.8643||||||The chi-squared test of homogeneity is used to assess whether the proportions of the independent variable (participant self-identified ethnicity) differ between groups (On PrEP vs. Off PrEP).|Fisher Exact|||||||0.8643
72465208|NCT01772823|144452834|OTHER|||||||0.9037||||||The chi-squared test of homogeneity is used to assess whether the proportions of the independent variable (participant BMI) differ between groups (On PrEP vs. Off PrEP).|Fisher Exact|||||||0.9037
72465209|NCT01772823|144452835|OTHER|||||||0.5279|||||||Kruskal-Wallis|||||||0.5279
72465210|NCT01772823|144452836|OTHER|||||||0.5369||||||The chi-squared test of homogeneity is used to assess whether the proportions of the independent variable (participation in high-risk sex acts) differ between groups (On PrEP vs. Off PrEP).|Fisher Exact|||||||0.5369
72465211|NCT01772823|144452839|OTHER|||||||0.2193||||||The chi-squared test of homogeneity is used to assess whether the proportions of the independent variable (participant responses to this question) differ between intervention arms.|Chi-squared|||||||0.2193
72465212|NCT01772823|144452840|OTHER|||||||0.1255||||||The chi-squared test of homogeneity is used to assess whether the proportions of the independent variable (participant responses to this question) differ between intervention arms.|Chi-squared|||||||0.1255
72465213|NCT01772823|144452841|OTHER|||||||0.0706||||||The chi-squared test of homogeneity is used to assess whether the proportions of the independent variable (participant responses to this question) differ between intervention arms.|Chi-squared|||||||0.0706
72465214|NCT01772823|144452842|OTHER|||||||0.0088||||||The chi-squared test of homogeneity is used to assess whether the proportions of the independent variable (participant responses to this question) differ between intervention arms.|Chi-squared|||||||0.0088
72502604|NCT04899271|144535875|SUPERIORITY|||||||1||||||Assumption of normality is not confirmed by Kolmogorov-Smirnov test; comparison between treatment arms is performed by means of two-sample Mann-Whitney U test.|Wilcoxon (Mann-Whitney)|||Comparison at month 18 for change from baseline||||1.000
72502605|NCT04899271|144535876|SUPERIORITY|||||||0.892||||||Assumption of normality is confirmed by Kolmogorov-Smirnov test; comparison between treatment arms is performed by means of two-sample t-test.|t-test, 2 sided|||Comparison at month 6 for change from baseline||||0.892
72502606|NCT04899271|144535876|SUPERIORITY|||||||0.412||||||Assumption of normality is confirmed by Kolmogorov-Smirnov test; comparison between treatment arms is performed by means of two-sample t-test.|t-test, 2 sided|||Comparison at month 12 for change from baseline||||0.412
72502607|NCT04899271|144535876|SUPERIORITY|||||||0.371||||||Assumption of normality is not confirmed by Kolmogorov-Smirnov test; comparison between treatment arms is performed by means of two-sample Mann-Whitney U test.|Wilcoxon (Mann-Whitney)|||Comparison at month 18 for change from baseline||||0.371
72564087|NCT01115855|144659712|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-40.79|STANDARD_ERROR_OF_MEAN|79.91|||TWO_SIDED|95.0|-197.55|115.97||||||Change from baseline at Month 33: Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||115.97|-197.55|
72564088|NCT01115855|144659712|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-44.48|STANDARD_ERROR_OF_MEAN|103.29|||TWO_SIDED|95.0|-247.11|158.15||||||Change from baseline at Month 37 : Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||158.15|-247.11|
72465215|NCT01772823|144452843|OTHER|||||||0.2482||||||The chi-squared test of homogeneity is used to assess whether the proportions of the independent variable (participant responses to this question) differ between intervention arms.|Chi-squared|||||||0.2482
72465216|NCT01772823|144452844|OTHER|||||||0.1647||||||The chi-squared test of homogeneity is used to assess whether the proportions of the independent variable (participant responses to this question) differ between intervention arms.|Chi-squared|||||||0.1647
72465217|NCT01772823|144452845|OTHER|||||||0.688||||||The chi-squared test of homogeneity is used to assess whether the proportions of the independent variable (participant responses to this question) differ between intervention arms.|Chi-squared|||||||0.6880
72502608|NCT00644592|144535881|SUPERIORITY_OR_OTHER||Ratio of mean effects|1.27|STANDARD_ERROR_OF_MEAN|0.16||0.015|TWO_SIDED|95.0|1.06|1.52|||t-test, 2 sided||The estimated mean log difference (SE) between the period 2 and period 1 effects and SE was estimated. This estimates twice the effect size\[since (B-A)-(A-B)=2B-2A\] so the actual estimate was based upon the antilog of half of this difference.|This is a crossover analysis. To convert to a ratio effect, the mean difference must be divided by two and antilogs take. The outcome represents a relative effect.||1.52|1.06|0.015
72502609|NCT02750410|144535913|SUPERIORITY||LS mean percent difference|-1.5|||<|0.001|TWO_SIDED|95.0|-1.73|-1.28|||Mixed Models Analysis|||||-1.28|-1.73|<0.001
72502610|NCT02750410|144535914|SUPERIORITY||Odds Ratio (OR)|0.117||||0.003|TWO_SIDED|95.0|0.028|0.479|||Regression, Logistic|||analysis was based on repeated measures logistic regression||0.479|0.028|0.003
72502611|NCT02750410|144535915|SUPERIORITY||LS mean difference|-30.14|||<|0.001|TWO_SIDED|95.0|-41.37|-18.91|||Mixed Models Analysis|||||-18.91|-41.37|<0.001
72502612|NCT02750410|144535916|SUPERIORITY||LS mean difference|-26.59|||<|0.001|TWO_SIDED|95.0|-36.39|-16.78|||t-test, 2 sided|||Prebreakfast BG||-16.78|-36.39|<0.001
72502613|NCT02750410|144535916|SUPERIORITY||LS mean difference|-45.38|||<|0.001|TWO_SIDED|95.0|-61.77|-29.0|||t-test, 2 sided|||Breakfast 2-hour PPBG||-29.00|-61.77|<0.001
72502614|NCT02750410|144535916|SUPERIORITY||LS mean difference|-36.82|||<|0.001|TWO_SIDED|95.0|-49.2|-24.45|||t-test, 2 sided|||Prelunch BG||-24.45|-49.20|<0.001
72502615|NCT02750410|144535916|SUPERIORITY||LS mean difference|-50.16|||<|0.001|TWO_SIDED|95.0|-67.85|-32.46|||t-test, 2 sided|||Lunch 2-hour PPBG||-32.46|-67.85|<0.001
72502616|NCT02750410|144535916|SUPERIORITY||LS mean difference|-31.27|||<|0.001|TWO_SIDED|95.0|-44.05|-18.48|||t-test, 2 sided|||Predinner BG||-18.48|-44.05|<0.001
72502617|NCT02750410|144535916|SUPERIORITY||LS mean difference|-34.97|||<|0.001|TWO_SIDED|95.0|-52.55|-17.38|||t-test, 2 sided|||Dinner 2-hour PPBG||-17.38|-52.55|<0.001
72465218|NCT01772823|144452846|OTHER|||||||0.2881||||||The chi-squared test of homogeneity is used to assess whether the proportions of the independent variable (participant responses to this question) differ between intervention arms.|Chi-squared|||||||0.2881
72502618|NCT02750410|144535916|SUPERIORITY||LS mean difference|-41.45|||<|0.001|TWO_SIDED|95.0|-58.81|-24.09|||t-test, 2 sided|||Bedtime BG||-24.09|-58.81|<0.001
72502619|NCT02750410|144535917|SUPERIORITY||LS mean difference|0.1||||0.776|TWO_SIDED|95.0|-0.59|0.78|||Mixed Models Analysis|||||0.78|-0.59|0.776
72502620|NCT04112914|144535940|SUPERIORITY||Mean Difference (Final Values)|0.27||||0.021|TWO_SIDED||||||Regression, Linear|||||||0.021
72502621|NCT04112914|144535941|SUPERIORITY||Mean Difference (Final Values)|0.06||||0.638|TWO_SIDED||||||Regression, Linear|||||||0.638
72502622|NCT04112914|144535942|SUPERIORITY||Odds Ratio (OR)|1.77||||0.338|TWO_SIDED|95.0|0.55|5.72|||Regression, Logistic|||||5.72|0.55|0.338
72502623|NCT04112914|144535943|SUPERIORITY||Mean Difference (Final Values)|0.13||||0.606|TWO_SIDED||||||Regression, Linear|||||||0.606
72465219|NCT01772823|144452847|OTHER|||||||0.2223||||||The chi-squared test of homogeneity is used to assess whether the proportions of the independent variable (participant responses to this question) differ between intervention arms.|Chi-squared|||||||0.2223
72465220|NCT01772823|144452848|OTHER|||||||0.0617||||||The chi-squared test of homogeneity is used to assess whether the proportions of the independent variable (participant responses to this question) differ between intervention arms.|Chi-squared|||||||0.0617
72502624|NCT04112914|144535944|SUPERIORITY||Mean Difference (Final Values)|0.12||||0.508|TWO_SIDED||||||Regression, Linear|||||||0.508
72465221|NCT01772823|144452849|OTHER|||||||0.0868||||||The chi-squared test of homogeneity is used to assess whether the proportions of the independent variable (participant responses to this question) differ between intervention arms.|Chi-squared|||||||0.0868
72502625|NCT04112914|144535945|SUPERIORITY||Mean Difference (Final Values)|0.45||||0.042|TWO_SIDED||||||Regression, Linear|||||||0.042
72502626|NCT04112914|144535946|SUPERIORITY||Mean Difference (Final Values)|0.16||||0.128|TWO_SIDED||||||Regression, Linear|||||||0.128
72502627|NCT02580058|144536006|SUPERIORITY||Hazard Ratio (HR)|1.14||||0.8253|TWO_SIDED|95.0|0.867|1.497|||Log Rank|1-sided||||1.497|0.867|0.8253
72502628|NCT02580058|144536006|SUPERIORITY||Hazard Ratio (HR)|0.89||||0.2082|TWO_SIDED|95.0|0.672|1.179|||Log Rank|1-sided||||1.179|0.672|0.2082
72502629|NCT02580058|144536007|SUPERIORITY||Hazard Ratio (HR)|1.68|||>|0.9999|TWO_SIDED|95.0|1.31|2.16|||Log Rank|1-sided||||2.160|1.310|>0.9999
72502630|NCT02580058|144536007|SUPERIORITY||Hazard Ratio (HR)|0.78||||0.0301|TWO_SIDED|95.0|0.607|1.011|||Log Rank|1-sided||||1.011|0.607|0.0301
72502631|NCT02580058|144536026|OTHER||Geometric Mean Ratio (Test/Reference, %)|110.0|||||TWO_SIDED|90.0|95.4|126.7||||||Avelumab was the Reference treatment and Avelumab + PLD was the Test treatment||126.7|95.4|
72502632|NCT02580058|144536027|OTHER||Geometric Mean Ratio (Test/Reference, %)|90.0|||||TWO_SIDED|90.0|79.5|101.5||||||Avelumab was the Reference treatment and Avelumab + PLD was the Test treatment||101.5|79.5|
72502633|NCT02580058|144536028|OTHER||Geometric Mean Ratio (Test/Reference, %)|96.0|||||TWO_SIDED|90.0|87.0|106.0||||||PLD was the Reference treatment and Avelumab + PLD was the Test treatment.||106|87|
72502634|NCT02580058|144536029|OTHER||Geometric Mean Ratio (Test/Reference, %)|95.0|||||TWO_SIDED|90.0|88.0|104.0||||||PLD was the Reference treatment and Avelumab + PLD was the Test treatment.||104|88|
72502635|NCT02580058|144536030|OTHER||Geometric Mean Ratio (Test/Reference, %)|90.0|||||TWO_SIDED|90.0|76.0|107.0||||||PLD was the Reference treatment and Avelumab + PLD was the Test treatment.||107|76|
72502636|NCT02580058|144536031|OTHER||Geometric Mean Ratio (Test/Reference, %)|100.0|||||TWO_SIDED|90.0|60.0|168.0||||||PLD was the Reference treatment and Avelumab + PLD was the Test treatment.||168|60|
72502637|NCT01193335|144536035|SUPERIORITY_OR_OTHER||Percent difference|-2.0|||||TWO_SIDED|95.0|-7.65|2.88||||||Serotype 4: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.||2.88|-7.65|
72502638|NCT01193335|144536035|SUPERIORITY_OR_OTHER||Percent difference|-14.9|||||TWO_SIDED|95.0|-26.4|-3.21||||||Serotype 6B: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.||-3.21|-26.40|
72502639|NCT01193335|144536035|SUPERIORITY_OR_OTHER||Percent difference|0.06|||||TWO_SIDED|95.0|-5.84|6.05||||||Serotype 9V: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.||6.05|-5.84|
72502640|NCT01193335|144536035|SUPERIORITY_OR_OTHER||Percent difference|2.06|||||TWO_SIDED|95.0|-1.71|7.25||||||Serotype 14: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.||7.25|-1.71|
72502641|NCT01193335|144536035|SUPERIORITY_OR_OTHER||Percent difference|2.12|||||TWO_SIDED|95.0|-4.09|8.89||||||Serotype 18C: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.||8.89|-4.09|
72502642|NCT01193335|144536035|SUPERIORITY_OR_OTHER||Percent difference|0.02|||||TWO_SIDED|95.0|-4.54|4.68||||||Serotype 19F: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.||4.68|-4.54|
72502643|NCT01193335|144536035|SUPERIORITY_OR_OTHER||Percent difference|-6.92|||||TWO_SIDED|95.0|-16.19|1.89||||||Serotype 23F: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.||1.89|-16.19|
72502644|NCT01193335|144536035|SUPERIORITY_OR_OTHER||Percent difference|-1.94|||||TWO_SIDED|95.0|-9.07|4.86||||||Serotype 1: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.||4.86|-9.07|
72502645|NCT01193335|144536035|SUPERIORITY_OR_OTHER||Percent difference|-4.86|||||TWO_SIDED|95.0|-14.4|4.39||||||Serotype 3: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.||4.39|-14.40|
72502646|NCT01193335|144536035|SUPERIORITY_OR_OTHER||Percent difference|-19.0|||||TWO_SIDED|95.0|-30.1|-7.16||||||Serotype 5: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.||-7.16|-30.10|
72502647|NCT01193335|144536035|SUPERIORITY_OR_OTHER||Percent difference|-12.19|||||TWO_SIDED|95.0|-21.66|-3.26||||||Serotype 6A: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.||-3.26|-21.66|
72465222|NCT01772823|144452850|OTHER|||||||0.1847||||||The chi-squared test of homogeneity is used to assess whether the proportions of the independent variable (participant responses to this question) differ between intervention arms.|Chi-squared|||||||0.1847
72465223|NCT01772823|144452851|OTHER|||||||0.0226||||||The chi-squared test of homogeneity is used to assess whether the proportions of the independent variable (participant responses to this question) differ between intervention arms.|Chi-squared|||||||0.0226
72465224|NCT00510146|144453116|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.15||||0.018|TWO_SIDED|95.0|-3.93|-0.36||p-value represents a comparison of the olanzapine and placebo groups in change from baseline to endpoint in MADRS total score from the following ANCOVA model: Change=Treatment+Baseline+Geographic Region.|ANCOVA|||||-0.36|-3.93|0.018
72465225|NCT00510146|144453117|SUPERIORITY_OR_OTHER|||||||0.05||95.0||||p-value represents a comparison of the olanzapine and placebo groups in percentage of participants with symptomatic response at endpoint from a Cochran-Mantel-Haenszel test using geographic region as strata.|Cochran-Mantel-Haenszel|||||||0.050
72465226|NCT00510146|144453118|SUPERIORITY_OR_OTHER|||||||0.367||95.0||||p-value represents a comparison of the olanzapine and placebo groups in percentage of participants with symptomatic remission at any time from a Cochran-Mantel-Haenszel test using region as strata.|Cochran-Mantel-Haenszel|||||||0.367
72465227|NCT00510146|144453119|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.11||||0.008|TWO_SIDED|95.0|-0.2|-0.03||p-value represents a comparison of the olanzapine and placebo groups in change from baseline to endpoint in CGI-BP Mania score from the following ANCOVA model: Change=Treatment+Baseline+Geographic Region.|ANCOVA|||||-0.03|-0.20|0.008
72465228|NCT00510146|144453119|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.24||||0.037|TWO_SIDED|95.0|-0.47|-0.01||p-value represents a comparison of the olanzapine and placebo groups in change from baseline to endpoint in CGI-BP Depression score from the following ANCOVA model: Change=Treatment+Baseline+Geographic Region.|ANCOVA|||||-0.01|-0.47|0.037
72465229|NCT00510146|144453119|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.3||||0.008|TWO_SIDED|95.0|-0.53|-0.08||p-value represents a comparison of the olanzapine and placebo groups in change from baseline to endpoint in CGI-BP Overall score from the following ANCOVA model: Change=Treatment+Baseline+Geographic Region.|ANCOVA|||||-0.08|-0.53|0.008
72465230|NCT00510146|144453120|SUPERIORITY_OR_OTHER|||||||0.156||95.0||||p-value represents a comparison of the olanzapine and placebo groups in percentage of participants with recovery from a Cochran-Mantel-Haenszel test using region as strata.|Cochran-Mantel-Haenszel|||||||0.156
72502648|NCT01193335|144536035|SUPERIORITY_OR_OTHER||Percent difference|0.02|||||TWO_SIDED|95.0|-4.54|4.68||||||Serotype 7F: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.||4.68|-4.54|
72564089|NCT01115855|144659712|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-27.69|STANDARD_ERROR_OF_MEAN|107.06|||TWO_SIDED|90.0|-238.31|182.93||||||Change from baseline at Month 42 : Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||182.93|-238.31|
72564090|NCT01115855|144659712|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-31.46|STANDARD_ERROR_OF_MEAN|96.48|||TWO_SIDED|95.0|-221.17|158.24||||||Change from baseline at Month 48: Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||158.24|-221.17|
72465231|NCT00510146|144453121|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.99|||<|0.001|TWO_SIDED|95.0|-1.56|-0.43||p-value represents a comparison of the olanzapine and placebo groups in change from baseline to endpoint from the following ANCOVA model: Change=Treatment+Baseline+Geographic Region.|ANCOVA|||||-0.43|-1.56|<0.001
72621316|NCT02732145|144773192|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of the Anterior Commissure among patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of non-specific lesions of the Anterior Commissure in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of vulvodynia."||||0.0000
72465232|NCT00510146|144453122|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.21||||0.002|TWO_SIDED|95.0|-3.61|-0.81||p-value represents a comparison of the olanzapine and placebo groups in change from baseline to endpoint from the following ANCOVA model: Change=Treatment+Baseline+Geographic Region.|ANCOVA|||||-0.81|-3.61|0.002
72465233|NCT00510146|144453123|SUPERIORITY_OR_OTHER|||||||0.297||95.0||||p-value represents a comparison of the olanzapine and placebo groups in percentage of participants with major depressive episode from a Cochran-Mantel-Haenszel test using geographic region as strata.|Cochran-Mantel-Haenszel|||||||0.297
72465234|NCT00510146|144453123|SUPERIORITY_OR_OTHER|||||||0.264||95.0||||p-value represents a comparison of the olanzapine and placebo groups in percentage of participants with major depressive episode with melancholic features from a Cochran-Mantel-Haenszel test using geographic region as strata.|Cochran-Mantel-Haenszel|||||||0.264
72465235|NCT00510146|144453124|SUPERIORITY_OR_OTHER|||||||0.195||95.0||||p-value represents a comparison of the olanzapine and placebo groups in percentage of participants with current hypomanic episode from a Cochran-Mantel-Haenszel test using geographic region as strata.|Cochran-Mantel-Haenszel|||||||0.195
72465236|NCT00510146|144453125|SUPERIORITY_OR_OTHER|||||||0.163||95.0||||p-value represents a comparison of the olanzapine and placebo groups in percentage of participants with current psychotic disorders from a Cochran-Mantel-Haenszel test using geographic region as strata.|Cochran-Mantel-Haenszel|||||||0.163
72502649|NCT01193335|144536035|SUPERIORITY_OR_OTHER||Percent difference|0.02|||||TWO_SIDED|95.0|-4.54|4.68||||||Serotype 19A: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.||4.68|-4.54|
72502650|NCT01193335|144536036|SUPERIORITY_OR_OTHER||GMC ratio|0.8|||||TWO_SIDED|95.0|0.62|1.02||||||Serotype 4: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||1.02|0.62|
72465237|NCT00510146|144453125|SUPERIORITY_OR_OTHER|||||||0.442||95.0||||p-value represents a comparison of the olanzapine and placebo groups in percentage of participants with current mood disorders with psychotic features from a Cochran-Mantel-Haenszel test using geographic region as strata.|Cochran-Mantel-Haenszel|||||||0.442
72465238|NCT00510146|144453126|SUPERIORITY_OR_OTHER|||||||1||95.0||||p-value represents a comparison of the olanzapine and placebo groups in percentage of participants with current alcohol dependence from a Cochran-Mantel-Haenszel test using geographic region as strata.|Cochran-Mantel-Haenszel|||||||1.00
72465239|NCT00510146|144453126|SUPERIORITY_OR_OTHER|||||||0.324||95.0||||p-value represents a comparison of the olanzapine and placebo groups in percentage of participants with current alcohol abuse from a Cochran-Mantel-Haenszel test using geographic region as strata.|Cochran-Mantel-Haenszel|||||||0.324
72465240|NCT00510146|144453128|SUPERIORITY_OR_OTHER|||||||0.031||95.0||||p-value represents a comparison of the olanzapine and placebo groups in percentage of participants with emergence of mania at endpoint from a Cochran-Mantel-Haenszel test using geographic region as strata.|Cochran-Mantel-Haenszel|||||||0.031
72465241|NCT00510146|144453129|SUPERIORITY_OR_OTHER|||||||0.269||95.0||||p-value represents a comparison of the olanzapine and placebo groups in percentage of participants with EPS symptoms (akathisia) at endpoint from a Cochran-Mantel-Haenszel test using geographic region as strata.|Cochran-Mantel-Haenszel|||||||0.269
72465242|NCT00510146|144453129|SUPERIORITY_OR_OTHER|||||||0.736||95.0||||p-value represents a comparison of the olanzapine and placebo groups in percentage of participants with EPS symptoms (parkinsonism) at endpoint from a Cochran-Mantel-Haenszel test using geographic region as strata.|Cochran-Mantel-Haenszel|||||||0.736
72465243|NCT00510146|144453130|SUPERIORITY_OR_OTHER|||||||0.146||95.0||||p-value represents a comparison of the olanzapine and placebo groups in change from baseline to endpoint-standing systolic blood pressure from the following ANCOVA model: Change=Treatment+Baseline+Geographic Region.|ANCOVA|||||||0.146
72465244|NCT00510146|144453130|SUPERIORITY_OR_OTHER|||||||0.249||95.0||||p-value represents a comparison of the olanzapine and placebo groups in change from baseline to endpoint-sitting systolic blood pressure from the following ANCOVA model: Change=Treatment+Baseline+Geographic Region.|ANCOVA|||||||0.249
72465245|NCT00510146|144453130|SUPERIORITY_OR_OTHER|||||||0.146||95.0||||p-value represents a comparison of the olanzapine and placebo groups in change from baseline to endpoint-standing diastolic blood pressure from the following ANCOVA model: Change=Treatment+Baseline+Geographic Region.|ANCOVA|||||||0.146
72465246|NCT00510146|144453130|SUPERIORITY_OR_OTHER|||||||0.271||95.0||||p-value represents a comparison of the olanzapine and placebo groups in change from baseline to endpoint-sitting diastolic blood pressure from the following ANCOVA model: Change=Treatment+Baseline+Geographic Region.|ANCOVA|||||||0.271
72465247|NCT00510146|144453130|SUPERIORITY_OR_OTHER|||||||0.284||95.0||||p-value represents a comparison of the olanzapine and placebo groups in change from baseline to endpoint-orthostatic change in systolic blood pressure from the following ANCOVA model: Change=Treatment+Baseline+Geographic Region.|ANCOVA|||||||0.284
72465248|NCT00510146|144453130|SUPERIORITY_OR_OTHER|||||||0.067||95.0||||p-value represents a comparison of the olanzapine and placebo groups in change from baseline to endpoint-orthostatic change in diastolic blood pressure from the following ANCOVA model: Change=Treatment+Baseline+Geographic Region.|ANCOVA|||||||0.067
72465249|NCT00510146|144453131|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value represents a comparison of the olanzapine and placebo groups in change from baseline to endpoint-in weight from the following ANCOVA model: Change=Treatment+Baseline+Geographic Region.|ANCOVA|||||||<0.001
72465250|NCT00510146|144453132|SUPERIORITY_OR_OTHER|||||||0.179||95.0||||p-value represents a comparison of the olanzapine and placebo groups in change from baseline to endpoint-in fasting glucose from the following ANCOVA model: Change=Treatment+Baseline+Geographic Region.|ANCOVA|||||||0.179
72465251|NCT00510146|144453132|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value represents a comparison of the olanzapine and placebo groups in change from baseline to endpoint-in cholesterol from the following ANCOVA model: Change=Treatment+Baseline+Geographic Region.|ANCOVA|||||||<0.001
72564091|NCT01115855|144659712|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-2.04|STANDARD_ERROR_OF_MEAN|28.85|||TWO_SIDED|95.0|-58.91|54.83||||||Change from baseline at Month 13 :ANCOVA with treatment effect and covariates of the NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||54.83|-58.91|
72564092|NCT01115855|144659714|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|0.08|STANDARD_ERROR_OF_MEAN|0.15|||TWO_SIDED|95.0|-0.21|0.37||||||Change from baseline at Month 5 : Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||0.37|-0.21|
72564093|NCT01115855|144659714|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.16|||TWO_SIDED|95.0|-0.34|0.3||||||Change from baseline at Month 9 :Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||0.30|-0.34|
72564094|NCT01115855|144659714|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|0.06|STANDARD_ERROR_OF_MEAN|0.17|||TWO_SIDED|95.0|-0.27|0.39||||||Change from baseline at Month 13: Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||0.39|-0.27|
72465252|NCT00510146|144453132|SUPERIORITY_OR_OTHER|||||||0.003||95.0||||p-value represents a comparison of the olanzapine and placebo groups in change from baseline to endpoint-in triglycerides from the following ANCOVA model: Change=Treatment+Baseline+Geographic Region.|ANCOVA|||||||0.003
72465253|NCT00510146|144453132|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value represents a comparison of the olanzapine and placebo groups in change from baseline to endpoint-in LDL cholesterol from the following ANCOVA model: Change=Treatment+Baseline+Geographic Region.|ANCOVA|||||||<0.001
72465254|NCT00510146|144453132|SUPERIORITY_OR_OTHER|||||||0.095||95.0||||p-value represents a comparison of the olanzapine and placebo groups in change from baseline to endpoint-in HDL cholesterol from the following ANCOVA model: Change=Treatment+Baseline+Geographic Region.|ANCOVA|||||||0.095
72465255|NCT00510146|144453133|SUPERIORITY_OR_OTHER|||||||0.001||95.0||||p-value represents a comparison of the olanzapine and placebo groups in change from baseline to endpoint in albumin from Wilcoxon's rank-sum test.|Wilcoxon (Mann-Whitney)|||||||0.001
72502651|NCT01193335|144536036|SUPERIORITY_OR_OTHER||GMC ratio|0.56|||||TWO_SIDED|95.0|0.38|0.82||||||Serotype 6B: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||0.82|0.38|
72502652|NCT01193335|144536036|SUPERIORITY_OR_OTHER||GMC ratio|0.74|||||TWO_SIDED|95.0|0.59|0.93||||||Serotype 9V: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||0.93|0.59|
72502653|NCT01193335|144536036|SUPERIORITY_OR_OTHER||GMC ratio|1.23|||||TWO_SIDED|95.0|0.92|1.65||||||Serotype 14: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||1.65|0.92|
72621317|NCT02732145|144773192|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of Interlabial Sulci among patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of non-specific lesions of Interlabial Sulci in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of vulvodynia."||||0.0000
72465256|NCT00510146|144453134|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value represents a comparison of the olanzapine and placebo groups in change from baseline to endpoint in ALT/SGPT from Wilcoxon's rank-sum test.|Wilcoxon (Mann-Whitney)|||||||<0.001
72465257|NCT00510146|144453134|SUPERIORITY_OR_OTHER|||||||0.001||95.0||||p-value represents a comparison of the olanzapine and placebo groups in change from baseline to endpoint in AST/SGOT from Wilcoxon's rank-sum test.|Wilcoxon (Mann-Whitney)|||||||0.001
72465258|NCT00510146|144453134|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value represents a comparison of the olanzapine and placebo groups in change from baseline to endpoint in GGT from Wilcoxon's rank-sum test.|Wilcoxon (Mann-Whitney)|||||||<0.001
72465259|NCT00510146|144453135|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value represents a comparison of the olanzapine and placebo groups in change from baseline to endpoint in direct bilirubin from Wilcoxon's rank-sum test.|Wilcoxon (Mann-Whitney)|||||||<0.001
72465260|NCT00510146|144453135|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value represents a comparison of the olanzapine and placebo groups in change from baseline to endpoint in total bilirubin from Wilcoxon's rank-sum test.|Wilcoxon (Mann-Whitney)|||||||<0.001
72465261|NCT00510146|144453135|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value represents a comparison of the olanzapine and placebo groups in change from baseline to endpoint in uric acid from Wilcoxon's rank-sum test.|Wilcoxon (Mann-Whitney)|||||||<0.001
72465262|NCT00510146|144453136|SUPERIORITY_OR_OTHER|||||||0.003||95.0||||p-value represents a comparison of the olanzapine and placebo groups in change from baseline to endpoint in erythrocyte count from Wilcoxon's rank-sum test.|Wilcoxon (Mann-Whitney)|||||||0.003
72465263|NCT00510146|144453137|SUPERIORITY_OR_OTHER|||||||0.001||95.0||||p-value represents a comparison of the olanzapine and placebo groups in change from baseline to endpoint in hematocrit from Wilcoxon's rank-sum test.|Wilcoxon (Mann-Whitney)|||||||0.001
72465264|NCT00510146|144453138|SUPERIORITY_OR_OTHER|||||||0.009||95.0||||p-value represents a comparison of the olanzapine and placebo groups in change from baseline to endpoint in hemoglobin A1c from Wilcoxon's rank-sum test.|Wilcoxon (Mann-Whitney)|||||||0.009
72465265|NCT00510146|144453139|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value represents a comparison of the olanzapine and placebo groups in change from baseline to endpoint in hemoglobin from Wilcoxon's rank-sum test.|Wilcoxon (Mann-Whitney)|||||||<0.001
72465266|NCT00510146|144453140|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value represents a comparison of the olanzapine and placebo groups in change from baseline to endpoint in prolactin from Wilcoxon's rank-sum test.|Wilcoxon (Mann-Whitney)|||||||<0.001
72465267|NCT00510146|144453141|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value represents a comparison of the olanzapine and placebo groups in change from baseline to endpoint in urinalysis-specific gravity from Wilcoxon's rank-sum test.|Wilcoxon (Mann-Whitney)|||||||<0.001
72465268|NCT00510146|144453142|SUPERIORITY_OR_OTHER|||||||0.104||95.0||||p-value represents a comparison of the olanzapine and placebo groups in change from baseline to endpoint in QTcF interval from the following ANCOVA model: Change=Treatment+Baseline+Geographic Region.|ANCOVA|||||||0.104
72465269|NCT00510146|144453142|SUPERIORITY_OR_OTHER|||||||0.006||95.0||||p-value represents a comparison of the olanzapine and placebo groups in change from baseline to endpoint in QTcB interval from the following ANCOVA model: Change=Treatment+Baseline+Geographic Region.|ANCOVA|||||||0.006
72465270|NCT00510146|144453143|SUPERIORITY_OR_OTHER|||||||0.035||95.0||||p-value represents a comparison of the olanzapine and placebo groups in change from baseline to endpoint in heart rate from the following ANCOVA model: Change=Treatment+Baseline+Geographic Region.|ANCOVA|||||||0.035
72465271|NCT00510146|144453144|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.02||||0.943|TWO_SIDED|95.0|-0.59|0.64||p-value represents a comparison of the olanzapine and placebo groups in change from baseline to endpoint for MINI Suicidality Total Score from the following ANCOVA model: Change=Treatment+Baseline+Geographic Region.|ANCOVA|||||0.64|-0.59|0.943
72465272|NCT00510146|144453152|SUPERIORITY_OR_OTHER|||||||0.736||95.0||||p-value represents change from baseline to endpoint-standing diastolic blood pressure from t-tests on change.|t-test, 2 sided|||||||0.736
72465273|NCT00510146|144453152|SUPERIORITY_OR_OTHER|||||||0.944||95.0||||p-value represents change from baseline to endpoint-sitting diastolic blood pressure from t-tests on change.|t-test, 2 sided|||||||0.944
72465274|NCT00510146|144453152|SUPERIORITY_OR_OTHER|||||||0.08||95.0||||p-value represents change from baseline to endpoint-standing systolic blood pressure from t-tests on change.|t-test, 2 sided|||||||0.080
72465275|NCT00510146|144453152|SUPERIORITY_OR_OTHER|||||||0.612||95.0||||p-value represents change from baseline to endpoint-sitting systolic blood pressure from t-tests on change.|t-test, 2 sided|||||||0.612
72465276|NCT00510146|144453152|SUPERIORITY_OR_OTHER|||||||0.64||95.0||||p-value represents change from baseline to endpoint-orthostatic change in diastolic blood pressure from t-tests on change.|t-test, 2 sided|||||||0.640
72502654|NCT01193335|144536036|SUPERIORITY_OR_OTHER||GMC ratio|1.0|||||TWO_SIDED|95.0|0.8|1.25||||||Serotype 18C: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||1.25|0.80|
72502655|NCT01193335|144536036|SUPERIORITY_OR_OTHER||GMC ratio|0.72|||||TWO_SIDED|95.0|0.58|0.9||||||Serotype 19F: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||0.90|0.58|
72502656|NCT01193335|144536036|SUPERIORITY_OR_OTHER||GMC ratio|0.64|||||TWO_SIDED|95.0|0.47|0.86||||||Serotype 23F: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||0.86|0.47|
72502657|NCT01193335|144536036|SUPERIORITY_OR_OTHER||GMC ratio|0.7|||||TWO_SIDED|95.0|0.55|0.89||||||Serotype 1: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||0.89|0.55|
72502658|NCT01193335|144536036|SUPERIORITY_OR_OTHER||GMC ratio|0.96|||||TWO_SIDED|95.0|0.77|1.19||||||Serotype 3: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||1.19|0.77|
72502659|NCT01193335|144536036|SUPERIORITY_OR_OTHER||GMC ratio|0.54|||||TWO_SIDED|95.0|0.4|0.72||||||Serotype 5: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||0.72|0.40|
72502660|NCT01193335|144536036|SUPERIORITY_OR_OTHER||GMC ratio|0.61|||||TWO_SIDED|95.0|0.45|0.82||||||Serotype 6A: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||0.82|0.45|
72502661|NCT01193335|144536036|SUPERIORITY_OR_OTHER||GMC ratio|0.71|||||TWO_SIDED|95.0|0.57|0.88||||||Serotype 7F: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||0.88|0.57|
72564095|NCT01115855|144659714|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|0.02|STANDARD_ERROR_OF_MEAN|0.22|||TWO_SIDED|95.0|-0.41|0.45||||||Change from baseline at Month 17 : Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||0.45|-0.41|
72564096|NCT01115855|144659714|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.2|||TWO_SIDED|95.0|-0.56|0.24||||||Change from baseline at Month 21 : Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||0.24|-0.56|
72502662|NCT01193335|144536036|SUPERIORITY_OR_OTHER||GMC ratio|0.85|||||TWO_SIDED|95.0|0.68|1.07||||||Serotype 19: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||1.07|0.68|
72502663|NCT01193335|144536045|SUPERIORITY_OR_OTHER|||||||0.668|TWO_SIDED||||||Fisher Exact|||AEs: Two sided Fisher exact test, was used to calculate difference between vaccine groups.||||0.668
72502664|NCT01193335|144536045|SUPERIORITY_OR_OTHER|||||||0.051|TWO_SIDED||||||Fisher Exact|||SAEs: Two sided Fisher exact test, was used to calculate difference between vaccine groups.||||0.051
72502665|NCT01193335|144536046|SUPERIORITY_OR_OTHER|||||||0.704|TWO_SIDED||||||Fisher Exact|||AEs: Two sided Fisher exact test, was used to calculate difference between vaccine groups.||||0.704
72502666|NCT01193335|144536046|SUPERIORITY_OR_OTHER||||||>|0.99|TWO_SIDED||||||Fisher Exact|||SAEs: Two sided Fisher exact test, was used to calculate difference between vaccine groups.||||>0.99
72502667|NCT01193335|144536047|SUPERIORITY_OR_OTHER|||||||0.531|TWO_SIDED||||||Fisher Exact|||AEs: Two sided Fisher exact test, was used to calculate difference between vaccine groups.||||0.531
72502668|NCT01193335|144536047|SUPERIORITY_OR_OTHER||||||>|0.99|TWO_SIDED||||||Fisher Exact|||SAEs: Two sided Fisher exact test, was used to calculate difference between vaccine groups.||||>0.99
72502669|NCT01193335|144536048|SUPERIORITY_OR_OTHER|||||||0.183|TWO_SIDED||||||Fisher Exact|||AEs: Two sided Fisher exact test, was used to calculate difference between vaccine groups.||||0.183
72502670|NCT01193335|144536048|SUPERIORITY_OR_OTHER|||||||0.357|TWO_SIDED||||||Fisher Exact|||SAEs: Two sided Fisher exact test, was used to calculate difference between vaccine groups.||||0.357
72502671|NCT01193335|144536049|SUPERIORITY_OR_OTHER|||||||0.794|TWO_SIDED||||||Fisher Exact|||AEs: Two sided Fisher exact test, was used to calculate difference between vaccine groups.||||0.794
72502672|NCT01193335|144536049|SUPERIORITY_OR_OTHER|||||||0.782|TWO_SIDED||||||Fisher Exact|||SAEs: Two sided Fisher exact test, was used to calculate difference between vaccine groups.||||0.782
72502673|NCT01193335|144536050|SUPERIORITY_OR_OTHER||GMFR Ratio|0.85|||||TWO_SIDED|95.0|0.63|1.14||||||Serotype 4: GMFR ratio was calculated by back transforming the GMFR difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on Student t distribution for the ratio difference of logarithms of the measures (Group 1 - Group 2).||1.14|0.63|
72502674|NCT01193335|144536050|SUPERIORITY_OR_OTHER||GMFR ratio|1.24|||||TWO_SIDED|95.0|0.95|1.62||||||Serotype 6B: GMFR ratio was calculated by back transforming the GMFR difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on Student t distribution for the ratio difference of logarithms of the measures (Group 1 - Group 2).||1.62|0.95|
72502675|NCT01193335|144536050|SUPERIORITY_OR_OTHER||GMFR ratio|1.19|||||TWO_SIDED|95.0|0.96|1.47||||||Serotype 9V: GMFR ratio was calculated by back transforming the GMFR difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on Student t distribution for the ratio difference of logarithms of the measures (Group 1 - Group 2).||1.47|0.96|
72502676|NCT01193335|144536050|SUPERIORITY_OR_OTHER||GMFR ratio|0.97|||||TWO_SIDED|95.0|0.74|1.26||||||Serotype 14: GMFR ratio was calculated by back transforming the GMFR difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on Student t distribution for the ratio difference of logarithms of the measures (Group 1 - Group 2).||1.26|0.74|
72502677|NCT01193335|144536050|SUPERIORITY_OR_OTHER||GMFR ratio|0.8|||||TWO_SIDED|95.0|0.63|1.02||||||Serotype 18C: GMFR ratio was calculated by back transforming the GMFR difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on Student t distribution for the ratio difference of logarithms of the measures (Group 1 - Group 2).||1.02|0.63|
72502678|NCT01193335|144536050|SUPERIORITY_OR_OTHER||GMFR ratio|0.88|||||TWO_SIDED|95.0|0.65|1.19||||||Serotype 19F: GMFR ratio was calculated by back transforming the GMFR difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on Student t distribution for the ratio difference of logarithms of the measures (Group 1 - Group 2).||1.19|0.65|
72502679|NCT01193335|144536050|SUPERIORITY_OR_OTHER||GMFR ratio|1.0|||||TWO_SIDED|95.0|0.74|1.33||||||Serotype 23F: GMFR ratio was calculated by back transforming the GMFR difference between the groups on the logarithmic scale.||1.33|0.74|
72564097|NCT01115855|144659714|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.2|||TWO_SIDED|95.0|-0.55|0.25||||||Change from baseline at Month 25 : Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||0.25|-0.55|
72465277|NCT00510146|144453152|SUPERIORITY_OR_OTHER|||||||0.122||95.0||||p-value represents change from baseline to endpoint-orthostatic change in systolic blood pressure from t-tests on change.|t-test, 2 sided|||||||0.122
72465278|NCT00510146|144453153|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value represents change from baseline to endpoint for weight from t-tests on change.|t-test, 2 sided|||||||<0.001
72564098|NCT01115855|144659714|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.2|||TWO_SIDED|95.0|-0.49|0.31||||||Change from baseline at Month 29 : Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||0.31|-0.49|
72564099|NCT01115855|144659714|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.26|||TWO_SIDED|95.0|-0.57|0.44||||||Change from baseline at Month 33 : Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||0.44|-0.57|
72465279|NCT00510146|144453154|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value represents change from baseline to endpoint for albumin from Wilcoxon's signed-rank test.|Wilcoxon (Mann-Whitney)|||||||<0.001
72502680|NCT01193335|144536050|SUPERIORITY_OR_OTHER||GMFR ratio|0.84|||||TWO_SIDED|95.0|0.64|1.11||||||Serotype 1: GMFR ratio was calculated by back transforming the GMFR difference between the groups on the logarithmic scale.||1.11|0.64|
72502681|NCT01193335|144536050|SUPERIORITY_OR_OTHER||GMFR ratio|1.46|||||TWO_SIDED|95.0|1.03|2.05||||||Serotype 3: GMFR ratio was calculated by back transforming the GMFR difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on Student t distribution for the ratio difference of logarithms of the measures (Group 1 - Group 2).||2.05|1.03|
72465280|NCT00510146|144453154|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||p-value represents change from baseline to endpoint for total protein from Wilcoxon's signed-rank test.|Wilcoxon (Mann-Whitney)|||||||0.002
72465281|NCT00510146|144453155|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||p-value represents change from baseline to endpoint for alkaline phosphatase from Wilcoxon's signed-rank test.|Wilcoxon (Mann-Whitney)|||||||0.002
72502682|NCT01193335|144536050|SUPERIORITY_OR_OTHER||GMFR ratio|1.0|||||TWO_SIDED|95.0|0.81|1.24||||||Serotype 5: GMFR ratio was calculated by back transforming the GMFR difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on Student t distribution for the ratio difference of logarithms of the measures (Group 1 - Group 2).||1.24|0.81|
72502683|NCT01193335|144536050|SUPERIORITY_OR_OTHER||GMFR ratio|1.36|||||TWO_SIDED|95.0|1.02|1.82||||||Serotype 6A: GMFR ratio was calculated by back transforming the GMFR difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on Student t distribution for the ratio difference of logarithms of the measures (Group 1 - Group 2).||1.82|1.02|
72502684|NCT01193335|144536050|SUPERIORITY_OR_OTHER||GMFR ratio|0.96|||||TWO_SIDED|95.0|0.78|1.18||||||Serotype 7F: GMFR ratio was calculated by back transforming the GMFR difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on Student t distribution for the ratio difference of logarithms of the measures (Group 1 - Group 2).||1.18|0.78|
72502685|NCT01193335|144536050|SUPERIORITY_OR_OTHER||GMFR ratio|1.15|||||TWO_SIDED|95.0|0.88|1.52||||||Serotype 19A: GMFR ratio was calculated by back transforming the GMFR difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on Student t distribution for the ratio difference of logarithms of the measures (Group 1 - Group 2).||1.52|0.88|
72502686|NCT01193335|144536052|SUPERIORITY_OR_OTHER||Percent difference|0.0|||||TWO_SIDED|95.0|-4.25|4.31||||||Serotype 4: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.||4.31|-4.25|
72502687|NCT01193335|144536052|SUPERIORITY_OR_OTHER||Percent difference|-2.33|||||TWO_SIDED|95.0|-8.15|1.96||||||Serotype 6B: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.||1.96|-8.15|
72502688|NCT01193335|144536052|SUPERIORITY_OR_OTHER||Percent difference|0.0|||||TWO_SIDED|95.0|-4.25|4.31||||||Serotype 9V: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.||4.31|-4.25|
72465282|NCT00510146|144453155|SUPERIORITY_OR_OTHER|||||||0.01||95.0||||p-value represents change from baseline to endpoint for CPK from Wilcoxon's signed-rank test.|Wilcoxon (Mann-Whitney)|||||||0.010
72465283|NCT00510146|144453155|SUPERIORITY_OR_OTHER|||||||0.354||95.0||||p-value represents change from baseline to endpoint for GGT from Wilcoxon's signed-rank test.|Wilcoxon (Mann-Whitney)|||||||0.354
72465284|NCT00510146|144453156|SUPERIORITY_OR_OTHER|||||||0.01||95.0||||p-value represents change from baseline to endpoint for chlorine from Wilcoxon's signed-rank test.|Wilcoxon (Mann-Whitney)|||||||0.010
72465285|NCT00510146|144453157|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value represents change from baseline to endpoint for creatinine from Wilcoxon's signed-rank test.|Wilcoxon (Mann-Whitney)|||||||<0.001
72465286|NCT00510146|144453158|SUPERIORITY_OR_OTHER|||||||0.021||95.0||||p-value represents change from baseline to endpoint for erythrocyte count from Wilcoxon's signed-rank test.|Wilcoxon (Mann-Whitney)|||||||0.021
72465287|NCT00510146|144453159|SUPERIORITY_OR_OTHER|||||||0.035||95.0||||p-value represents change from baseline to endpoint for hemoglobin from Wilcoxon's signed-rank test.|Wilcoxon (Mann-Whitney)|||||||0.035
72465288|NCT00510146|144453160|SUPERIORITY_OR_OTHER|||||||0.024||95.0||||p-value represents change from baseline to endpoint for platelet count from Wilcoxon's signed-rank test.|Wilcoxon (Mann-Whitney)|||||||0.024
72465289|NCT00510146|144453161|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value represents change from baseline to endpoint for prolactin from Wilcoxon's signed-rank test.|Wilcoxon (Mann-Whitney)|||||||<0.001
72465290|NCT00510146|144453162|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value represents change from baseline to endpoint for uric acid from Wilcoxon's signed-rank test.|Wilcoxon (Mann-Whitney)|||||||<0.001
72465291|NCT00510146|144453163|SUPERIORITY_OR_OTHER|||||||0.047||95.0||||p-value represents change from baseline to endpoint for fasting glucose from t-tests on change.|t-test, 2 sided|||||||0.047
72465292|NCT00510146|144453163|SUPERIORITY_OR_OTHER|||||||0.13||95.0||||p-value represents change from baseline to endpoint for cholesterol from t-tests on change.|t-test, 2 sided|||||||0.130
72465293|NCT00510146|144453163|SUPERIORITY_OR_OTHER|||||||0.055||95.0||||p-value represents change from baseline to endpoint for triglycerides from t-tests on change.|t-test, 2 sided|||||||0.055
72465294|NCT00510146|144453163|SUPERIORITY_OR_OTHER|||||||0.049||95.0||||p-value represents change from baseline to endpoint for LDL cholesterol from t-tests on change.|t-test, 2 sided|||||||0.049
72465295|NCT00510146|144453163|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value represents change from baseline to endpoint for HDL cholesterol from t-tests on change.|t-test, 2 sided|||||||<0.001
72465296|NCT00510146|144453164|SUPERIORITY_OR_OTHER|||||||0.023||95.0||||p-value represents change from baseline to endpoint for QTcF from t-test.|t-test, 2 sided|||||||0.023
72465297|NCT00510146|144453164|SUPERIORITY_OR_OTHER|||||||0.044||95.0||||p-value represents change from baseline to endpoint for QTcB from t-test.|t-test, 2 sided|||||||0.044
72465298|NCT00510146|144453165|SUPERIORITY_OR_OTHER|||||||0.919||95.0||||p-value represents change from baseline to endpoint for heart rate from t-test.|t-test, 2 sided|||||||0.919
72564100|NCT01115855|144659714|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|0.02|STANDARD_ERROR_OF_MEAN|0.26|||TWO_SIDED|95.0|-0.5|0.54||||||Change from baseline at Month 37 :Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||0.54|-0.50|
72465299|NCT02864342|144453176|OTHER||||||<|0.001|||||||Satterthwaite t-test|||The effect of medication reminders on Symbicort adherence was evaluated using a t-test. The equality of variances was also tested and as the variances were not equal, the Satterthwaite-t test was reported.||||<0.001
72465300|NCT01149876|144453213|SUPERIORITY_OR_OTHER|||||||0.05|||||||t-test, 2 sided|||||||0.05
72465301|NCT01149876|144453213|SUPERIORITY_OR_OTHER|||||||0.25|||||||t-test, 2 sided|||||||.25
72465302|NCT01149876|144453213|SUPERIORITY_OR_OTHER|||||||0.48|||||||t-test, 2 sided|||||||.48
72465303|NCT00702273|144453240|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority margin of -8%|Risk Difference (RD)|2.4|||||TWO_SIDED|95.0|-2.6|7.4||||||Treatment groups were compared with a generalized linear model including covariates treatment group, age class and region.||7.4|-2.6|
72465304|NCT02920021|144453261|SUPERIORITY||Least Squares (LS) Mean Difference|60.046|STANDARD_ERROR_OF_MEAN|79.918||0.463|TWO_SIDED|95.0|-108.566|228.657|||ANCOVA|Analysis of covariance (ANCOVA) model with treatment as fixed effect and baseline value as covariate.|Treatment Difference = Etokimab - Placebo|||228.657|-108.566|0.463
72465305|NCT02920021|144453262|SUPERIORITY||LS Mean Difference|0.001|STANDARD_ERROR_OF_MEAN|0.016||0.962|TWO_SIDED|95.0|-0.031|0.032|||ANCOVA|ANCOVA model with treatment as fixed effect and baseline value as covariate.|Treatment Difference = Etokimab - Placebo|||0.032|-0.031|0.962
72465306|NCT04522778|144453272|OTHER|||||||0.029|||||||t-test, 1 sided|||A ratio of events per month was calculated for each participant. Participants were compared to themselves prior to intervention (i.e. event ratios pre intervention were compared to event ratios following intervention.)||||.029
72465307|NCT04522778|144453273|SUPERIORITY|||||||0.35|||||||t-test, 1 sided|||A ratio of events per month was calculated for each participant. Participants were compared to themselves prior to intervention (i.e. event ratios pre intervention were compared to event ratios following intervention.)||||.35
72465308|NCT04522778|144453274|SUPERIORITY|||||||0.334|||||||t-test, 1 sided|||||||.334
72465309|NCT04522778|144453275|SUPERIORITY||Odds Ratio (OR)|38.26|STANDARD_ERROR_OF_MEAN|50.195||0.005|TWO_SIDED|95.0|2.926154|500.4402|||Chi-squared|||||500.4402|2.926154|.005
72465310|NCT04522778|144453276|SUPERIORITY||Odds Ratio (OR)|30.975|STANDARD_ERROR_OF_MEAN|35.73483||0.003|TWO_SIDED|95.0|3.22|297.17|||Chi-squared|||||297.17|3.22|.003
72465311|NCT04522778|144453277|SUPERIORITY||Odds Ratio (OR)|27.36|STANDARD_ERROR_OF_MEAN|31.72||0.004|TWO_SIDED|95.0|2.82|265.45|||Chi-squared|||||265.45|2.82|.004
72465312|NCT04522778|144453278|SUPERIORITY||Odds Ratio (OR)|10.93|STANDARD_ERROR_OF_MEAN|10.345||0.011|TWO_SIDED|95.0|1.71|69.82|||Chi-squared|||||69.82|1.71|.011
72465313|NCT04522778|144453279|SUPERIORITY||Odds Ratio (OR)|0.298|STANDARD_ERROR_OF_MEAN|0.2189||0.099|TWO_SIDED|95.0|0.0706|1.258|||Chi-squared|||||1.258|.0706|.099
72465314|NCT04522778|144453280|SUPERIORITY||Odds Ratio (OR)|1.201|STANDARD_ERROR_OF_MEAN|1.201||0.312|TWO_SIDED|95.0|0.549|6.562|||Chi-squared|||||6.562|.549|.312
72465315|NCT04522778|144453281|SUPERIORITY||Odds Ratio (OR)|1.519|STANDARD_ERROR_OF_MEAN|2.022||0.753|TWO_SIDED|95.0|0.112|20.623|||Chi-squared|||||20.623|.112|.753
72465316|NCT04522778|144453282|SUPERIORITY||Odds Ratio (OR)|0.321|STANDARD_ERROR_OF_MEAN|0.257||0.156|TWO_SIDED|95.0|0.067|1.541|||Chi-squared|||||1.541|.067|.156
72465317|NCT04522778|144453283|SUPERIORITY||Odds Ratio (OR)|0.458|STANDARD_ERROR_OF_MEAN|0.358||0.318|TWO_SIDED|95.0|0.099|2.122|||Chi-squared|||||2.122|.099|.318
72465318|NCT04522778|144453284|SUPERIORITY||Odds Ratio (OR)|0.449|STANDARD_ERROR_OF_MEAN|0.882||0.684|TWO_SIDED|95.0|0.009|21.003|||Chi-squared|||||21.003|.009|.684
72465319|NCT04522778|144453285|SUPERIORITY||Odds Ratio (OR)|2.335|STANDARD_ERROR_OF_MEAN|2.683||0.46|TWO_SIDED|95.0|0.246|22.194|||Chi-squared|||||22.194|.246|.460
72465320|NCT04522778|144453286|SUPERIORITY||Odds Ratio (OR)|2.299|STANDARD_ERROR_OF_MEAN|2.47293||0.439|TWO_SIDED|95.0|0.279|18.927|||Chi-squared|||||18.927|.279|.439
72465321|NCT04522778|144453287|SUPERIORITY||Odds Ratio (OR)|1.634|STANDARD_ERROR_OF_MEAN|2.187||0.714|TWO_SIDED|95.0|0.119|22.514|||Chi-squared|||||22.514|.119|.714
72465322|NCT04522778|144453288|SUPERIORITY||Odds Ratio (OR)|0.379|STANDARD_ERROR_OF_MEAN|0.448||0.412|TWO_SIDED|95.0|0.037|3.842|||Chi-squared|||||3.842|.037|.412
72465323|NCT04522778|144453289|SUPERIORITY||Odds Ratio (OR)|0.579|STANDARD_ERROR_OF_MEAN|0.539||0.558|TWO_SIDED|95.0|0.094|3.582|||Chi-squared|||||3.582|.094|.558
72465324|NCT04522778|144453290|SUPERIORITY||Odds Ratio (OR)|0.688|STANDARD_ERROR_OF_MEAN|0.609||0.673|TWO_SIDED|95.0|0.121|3.9|||Chi-squared|||||3.90|.121|.673
72465325|NCT04522778|144453291|SUPERIORITY||Odds Ratio (OR)|0.674|STANDARD_ERROR_OF_MEAN|0.438||0.544|TWO_SIDED|95.0|0.189|2.406|||Chi-squared|||||2.406|.189|.544
72502689|NCT01193335|144536052|SUPERIORITY_OR_OTHER||Percent difference|0.0|||||TWO_SIDED|95.0|-4.25|4.31||||||Serotype 14: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.||4.31|-4.25|
72502690|NCT01193335|144536052|SUPERIORITY_OR_OTHER||Percent difference|1.15|||||TWO_SIDED|95.0|-3.13|6.24||||||Serotype 18C: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.||6.24|-3.13|
72465326|NCT04522778|144453292|SUPERIORITY||Odds Ratio (OR)|1.88|STANDARD_ERROR_OF_MEAN|1.631||0.464|TWO_SIDED|95.0|0.345|10.278|||Chi-squared|||||10.278|.345|.464
72465327|NCT04522778|144453293|SUPERIORITY||Odds Ratio (OR)|5.595|STANDARD_ERROR_OF_MEAN|5.675||0.09|TWO_SIDED|95.0|0.766|40.854|||Chi-squared|||||40.854|.766|.090
72465328|NCT04522778|144453294|SUPERIORITY||Odds Ratio (OR)|0.987|STANDARD_ERROR_OF_MEAN|1.119||0.991|TWO_SIDED|95.0|0.107|9.114|||Chi-squared|||||9.114|.107|.991
72465329|NCT04522778|144453295|SUPERIORITY||Odds Ratio (OR)|4.239|STANDARD_ERROR_OF_MEAN|5.027||0.223|TWO_SIDED|95.0|0.415|43.326|||Chi-squared|||||43.326|.415|.223
72465330|NCT04522778|144453296|SUPERIORITY||Odds Ratio (OR)|2.199|STANDARD_ERROR_OF_MEAN|2.496||0.488|TWO_SIDED|95.0|0.238|20.348|||Chi-squared|||||20.348|.238|.488
72465331|NCT04522778|144453297|SUPERIORITY||Odds Ratio (OR)|0.177|STANDARD_ERROR_OF_MEAN|0.129||0.018|TWO_SIDED|95.0|0.0424|0.743|||Chi-squared|||||.743|.0424|.018
72465332|NCT04522778|144453298|SUPERIORITY||Odds Ratio (OR)|3.688|STANDARD_ERROR_OF_MEAN|4.358||0.269|TWO_SIDED|95.0|0.364|37.379|||Chi-squared|||||37.379|.364|.269
72502691|NCT01193335|144536052|SUPERIORITY_OR_OTHER||Percent difference|0.0|||||TWO_SIDED|95.0|-4.25|4.31||||||Serotype 19F: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.||4.31|-4.25|
72502692|NCT01193335|144536052|SUPERIORITY_OR_OTHER||Percent difference|-1.16|||||TWO_SIDED|95.0|-6.32|3.1||||||Serotype 23F: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.||3.10|-6.32|
72502693|NCT01193335|144536052|SUPERIORITY_OR_OTHER||Percent difference|0.0|||||TWO_SIDED|95.0|-4.25|4.31||||||Serotype 1: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.||4.31|-4.25|
72502694|NCT01193335|144536052|SUPERIORITY_OR_OTHER||Percent difference|-8.72|||||TWO_SIDED|95.0|-21.93|4.42||||||Serotype 3: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.||4.42|-21.93|
72465333|NCT04522778|144453299|SUPERIORITY||Odds Ratio (OR)|4.251|STANDARD_ERROR_OF_MEAN|3.829||0.108|TWO_SIDED|95.0|0.728|24.84|||Chi-squared|||||24.84|.728|.108
72465334|NCT04522778|144453300|SUPERIORITY||Odds Ratio (OR)|3.658|STANDARD_ERROR_OF_MEAN|2.99||0.113|TWO_SIDED|95.0|0.737|18.157|||Chi-squared|||||18.157|.737|.113
72465335|NCT04522778|144453301|SUPERIORITY||Odds Ratio (OR)|2.495|STANDARD_ERROR_OF_MEAN|1.156||0.049|TWO_SIDED|95.0|1.004|6.202|||Chi-squared|||||6.202|1.004|.049
72465336|NCT05400226|144453302|OTHER|Summary statistics of quantitative data, one-sided exact binomial test for null hypothesis, Clopper-Pearson method for 95% exact confidence intervals|Proportion|0.425|||<|0.0001|TWO_SIDED|95.0|0.27|0.591|||Exact Binomial Test||The Parameter Dispersion Value is the asymptotic standard error of the proportion.|Single arm open-label||0.591|0.270|< .0001
72465337|NCT05400226|144453303|OTHER||Proportion|0.85|||||TWO_SIDED|95.0|0.675|0.939||||||||0.939|0.675|
72465338|NCT05400226|144453304|OTHER||Proportion|0.455|||||TWO_SIDED|95.0|0.202|0.733||||||||0.733|0.202|
72465339|NCT05400226|144453305|OTHER||Proportion|0.333|||||TWO_SIDED|95.0|0.126|0.633||||||||0.633|0.126|
72465340|NCT05400226|144453306|OTHER||Proportion|0.773|||||TWO_SIDED|95.0|0.65|0.862||||||||0.862|0.650|
72465341|NCT02551692|144453320|OTHER||Partial sum of squares|855.65||||0.534|TWO_SIDED||||||ANOVA|||||||0.534
72465342|NCT02551692|144453321|OTHER||Partial sum of squares|29602.69||||0.26|TWO_SIDED||||||ANOVA|||||||0.26
72465343|NCT02551692|144453322|OTHER||Partial sum of squares|101.69||||0.318|TWO_SIDED||||||ANCOVA|||||||0.318
72465344|NCT04167085|144453348|SUPERIORITY|||||||0.16||||||Threshold p\<0.0167 - Because 3 primary outcomes were prespecified, the familywise error rate was adjusted for 3 endpoints: 0.05/3|Wilcoxon (Mann-Whitney)|||||||0.16
72465345|NCT04167085|144453349|SUPERIORITY|||||||0.05||||||Threshold p\<0.0167 - Because 3 primary outcomes were prespecified, the familywise error rate was adjusted for 3 endpoints: 0.05/3|Wilcoxon (Mann-Whitney)|||||||0.05
72502695|NCT01193335|144536052|SUPERIORITY_OR_OTHER||Percent difference|0.0|||||TWO_SIDED|95.0|-4.25|4.31||||||Serotype 5: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.||4.31|-4.25|
72465346|NCT04167085|144453350|SUPERIORITY|||||||0.19||||||Threshold p\<0.0167 - Because 3 primary outcomes were prespecified, the familywise error rate was adjusted for 3 endpoints: 0.05/3|Wilcoxon (Mann-Whitney)|||||||0.19
72465347|NCT04167085|144453351|SUPERIORITY|||||||0.24||||||Threshold p=0.05|Wilcoxon (Mann-Whitney)|||SF-12 Physical||||0.24
72465348|NCT04167085|144453351|SUPERIORITY|||||||0.35||||||Threshold p=0.05|Wilcoxon (Mann-Whitney)|||SF-12 Mental||||0.35
72465349|NCT04167085|144453352|SUPERIORITY|||||||0.5||||||Threshold p=0.05|Wilcoxon (Mann-Whitney)|||||||0.50
72465350|NCT04167085|144453353|SUPERIORITY|||||||0.3||||||Threshold p=0.05|Wilcoxon (Mann-Whitney)|||||||0.30
72465351|NCT04167085|144453354|SUPERIORITY|||||||1||||||Threshold p=0.05|Wilcoxon (Mann-Whitney)|||||||1.00
72465352|NCT00006436|144453369|SUPERIORITY|||||||0.1|||||||Two-tailed log rank test||||Compared the PFS of interim PET positive participants to the PFS of interim PET negative.|||0.10
72465353|NCT00276016|144453390|SUPERIORITY_OR_OTHER_LEGACY|||||||0.561||95.0|||||ANOVA|||For endpoint||||0.561
72465354|NCT00276016|144453391|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||ANOVA|||For endpoint||||<.001
72465355|NCT00835510|144453407|SUPERIORITY_OR_OTHER|||||||0.0127||95.0|||||Fisher Exact|two-sided||||||0.0127
72465356|NCT00835510|144453407|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Fisher Exact|two-sided||||||<0.0001
72465357|NCT00835510|144453412|NON_INFERIORITY_OR_EQUIVALENCE|The criteria for equivalence is that the 90% confidence interval for the difference in cure rate had to be between -20% to +20%.|Cure rate difference|-19.78||||||90.0|-30.27|-9.29||||||||-9.29|-30.27|
72465358|NCT03713281|144453425|SUPERIORITY||Least-square mean|-0.131|STANDARD_ERROR_OF_MEAN|0.0278|||TWO_SIDED|95.0|-0.208|-0.054|||Linear Mixed Model|Kenward and Roger modethod for the demoninator degrees of freedom.||Statistically superiority will be concluded if the upper confidence limit will be less than 0.10 logMAR.||-0.054|-0.208|
72465359|NCT03713281|144453426|SUPERIORITY||Least-square means|0.06|STANDARD_ERROR_OF_MEAN|0.0278|||TWO_SIDED|95.0|-0.017|0.137|||Linear Mixed Model|Kenward and Roger method for the demoninator degrees of freedom.||Statistically superiority will be concluded if the upper confidence limit will be less than 0.17 logMAR for near distance logMAR visual acuity.||0.137|-0.017|
72465360|NCT02705625|144453461|SUPERIORITY|"For the primary endpoint, the Type I error for the tests of the two doses was protected by performing a fixed-sequence multiple-testing procedure in the following order:~Step 1: 200 mg versus placebo Step 2: 100 mg versus placebo The second step was only considered as confirmatory provided the previous step was significant at a one-sided 5%-level (p\<0.05).~If the previous step was not significant, the analysis of the following step was considered descriptive."|Mean Difference (Final Values)|-0.0761||||0.4055|TWO_SIDED|95.0|-0.703|0.55||The p-values reported is from Step 1 (comparing 200 mg versus placebo). The corresponding p-value from Step 2 (comparing 100 mg versus placebo) was 0.1458.|Mixed Models Analysis|||A linear mixed model based on the mITT population was used. The model included fixed factors for treatment, time (measured in weeks), the interaction for treatment by time, baseline analgesic user (Yes/No), and random effect for clinical site. Baseline NRS was included as a covariate for adjustment. An unstructured covariance matrix was used to model the covariance pattern in the mixed effects model.||0.55|-0.703|0.4055
72465361|NCT02705625|144453462|SUPERIORITY|One model is fit for all comparison groups (MIV-711 200 mg, MIV-711 100 mg and placebo). This analysis reports the contrast that compares 200 mg versus placebo with respect to mean change from baseline in knee joint MRI bone area at Week 26.|Mean Difference (Final Values)|-14.7||||0.0036|TWO_SIDED|95.0|-25.3|-4.02||p-values reported are unadjusted p-values for tests of significance for the upper one-tailed alternative hypothesis Ha: bone area increase is lower in the active treatment arm compared to placebo.|Mixed Models Analysis|||"A linear mixed model based on the mITT population was used. The model included fixed factors for treatment, time (measured in weeks), the interaction for treatment-by-time, baseline analgesic user (Yes/No), and random effect for clinical site. Baseline knee joint MRI bone area was included as a covariate for adjustment.~An unstructured covariance matrix was used to model the covariance pattern in the mixed effects model."||-4.02|-25.3|0.0036
72465362|NCT02705625|144453462|SUPERIORITY|One model is fit for all comparison groups (MIV-711 200 mg, MIV-711 100 mg and placebo). This analysis reports the contrast that compares 100 mg versus placebo with respect to mean change from baseline in knee joint MRI bone area at Week 26.|Mean Difference (Final Values)|-15.4||||0.0023|TWO_SIDED|95.0|-26.0|-4.83||p-values reported are unadjusted p-values for tests of significance for the upper one-tailed alternative hypothesis Ha: bone area increase is lower in the active treatment arm compared to placebo.|Mixed Models Analysis|||"A linear mixed model based on the mITT population was used. The model included fixed factors for treatment, time (measured in weeks), the interaction for treatment-by-time, baseline analgesic user (Yes/No), and random effect for clinical site. Baseline knee joint MRI bone area was included as a covariate for adjustment.~An unstructured covariance matrix was used to model the covariance pattern in the mixed effects model."||-4.83|-26|0.0023
72465363|NCT02705625|144453463|SUPERIORITY|One model is fit for all comparison groups (MIV-711 200 mg, MIV-711 100 mg and placebo). This analysis reports the contrast that compares 200 mg versus placebo with respect to mean change from baseline in MRI of cartilage thickness (Femur Region) at Week 26.|Mean Difference (Final Values)|0.0436||||0.1253|TWO_SIDED|95.0|-0.031|0.118||p-values reported are unadjusted p-values for tests of significance for the upper one-tailed alternative hypothesis Ha: MRI of cartilage thinning (Femur Region) is lower in the active treatment arm compared to placebo.|Mixed Models Analysis|||"A linear mixed model based on the mITT population was used. The model included fixed factors for treatment, time (measured in weeks), the interaction for treatment-by-time, baseline analgesic user (Yes/No), and random effect for clinical site. Baseline MRI of cartilage thickness was included as a covariate for adjustment.~An unstructured covariance matrix was used to model the covariance pattern in the mixed effects model."||0.118|-0.031|0.1253
72502696|NCT01193335|144536052|SUPERIORITY_OR_OTHER||Percent difference|0.0|||||TWO_SIDED|95.0|-4.25|4.31||||||Serotype 6A: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.||4.31|-4.25|
72502697|NCT01193335|144536052|SUPERIORITY_OR_OTHER||Percent difference|0.0|||||TWO_SIDED|95.0|-4.25|4.31||||||Serotype 7F: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.||4.31|-4.25|
72564101|NCT01115855|144659714|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|0.32|||TWO_SIDED|90.0|-0.44|0.83||||||Change from baseline at Month 42 :Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||0.83|-0.44|
72564102|NCT01115855|144659714|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|0.13|STANDARD_ERROR_OF_MEAN|0.38|||TWO_SIDED|95.0|-0.63|0.89||||||Change from baseline at Month 48 : Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||0.89|-0.63|
72564103|NCT01115855|144659714|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.12|||TWO_SIDED|95.0|-0.36|0.11||||||Change from baseline at Week 4 : Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||0.11|-0.36|
72465364|NCT02705625|144453463|SUPERIORITY|One model is fit for all comparison groups (MIV-711 200 mg, MIV-711 100 mg and placebo). This analysis reports the contrast that compares 100 mg versus placebo with respect to mean change from baseline in MRI of cartilage thickness (Femur Region) at Week 26.|Mean Difference (Final Values)|0.0761||||0.0225|TWO_SIDED|95.0|0.00173|0.15||p-values reported are unadjusted p-values for tests of significance for the upper one-tailed alternative hypothesis Ha: MRI of cartilage thinning (Femur Region) is lower in the active treatment arm compared to placebo.|Mixed Models Analysis|||"A linear mixed model based on the mITT population was used. The model included fixed factors for treatment, time (measured in weeks), the interaction for treatment-by-time, baseline analgesic user (Yes/No), and random effect for clinical site. Baseline MRI of cartilage thickness was included as a covariate for adjustment.~An unstructured covariance matrix was used to model the covariance pattern in the mixed effects model."||0.15|0.00173|0.0225
72465365|NCT02705625|144453464|SUPERIORITY|One model is fit for all comparison groups (MIV-711 200 mg, MIV-711 100 mg and placebo). This analysis reports the contrast that compares 200 mg versus placebo with respect to mean change from baseline in WOMAC Pain score at Week 26.|Mean Difference (Final Values)|-1.77||||0.2887|TWO_SIDED|95.0|-8.02|4.48||p-values reported are unadjusted p-values for tests of significance for the lower one-tailed alternative hypothesis Ha: Reduction in WOMAC Pain score is higher in the active treatment arm compared to placebo.|Mixed Models Analysis|||"A linear mixed model based on the mITT population was used. The model included fixed factors for treatment, time (measured in weeks), the interaction for treatment-by-time,baseline analgesic user (Yes/No), and random effect for clinical site. Baseline WOMAC Pain score was included as a covariate for adjustment.~An unstructured covariance matrix was used to model the covariance pattern in the mixed effects model."||4.48|-8.02|0.2887
72465366|NCT02705625|144453464|SUPERIORITY|One model is fit for all comparison groups (MIV-711 200 mg, MIV-711 100 mg and placebo). This analysis reports the contrast that compares 100 mg versus placebo with respect to mean change from baseline in WOMAC Pain score at Week 26.|Mean Difference (Final Values)|-4.55||||0.0753|TWO_SIDED|95.0|-10.8|1.67||p-values reported are unadjusted p-values for tests of significance for the lower one-tailed alternative hypothesis Ha: Reduction in WOMAC Pain score is higher in the active treatment arm compared to placebo.|Mixed Models Analysis|||"A linear mixed model based on the mITT population was used. The model included fixed factors for treatment, time (measured in weeks), the interaction for treatment-by-time, baseline analgesic (Yes/No) and random effect for clinical site. Baseline WOMAC Pain score was included as a covariate for adjustment.~An unstructured covariance matrix was used to model the covariance pattern in the mixed effects model."||1.67|-10.8|0.0753
72465367|NCT02705625|144453465|SUPERIORITY|One model is fit for all comparison groups (MIV-711 200 mg, MIV-711 100 mg and placebo). This analysis reports the contrast that compares 200 mg versus placebo with respect to mean change from baseline in WOMAC difficulty score at Week 26.|Mean Difference (Final Values)|-1.84||||0.2898|TWO_SIDED|95.0|-8.38|4.7||p-values reported are unadjusted p-values for tests of significance for the lower one-tailed alternative hypothesis Ha: Reduction in WOMAC Difficulty score is higher in the active treatment arm compared to placebo.|Mixed Models Analysis|||"A linear mixed model based on the mITT population was used. The model included fixed factors for treatment, time (measured in weeks), the interaction for treatment-by-time, baseline analgesic (Yes/No) and random effect for clinical site. Baseline WOMAC Difficulty score was included as a covariate for adjustment.~An unstructured covariance matrix was used to model the covariance pattern in the mixed effects model."||4.7|-8.38|0.2898
72465368|NCT02705625|144453465|SUPERIORITY|One model is fit for all comparison groups (MIV-711 200 mg, MIV-711 100 mg and placebo). This analysis reports the contrast that compares 100 mg versus placebo with respect to mean change from baseline in WOMAC difficulty score at Week 26.|Mean Difference (Final Values)|-3.78||||0.1262|TWO_SIDED|95.0|-10.3|2.72||p-values reported are unadjusted p-values for tests of significance for the lower one-tailed alternative hypothesis Ha: Reduction in WOMAC Difficulty score is higher in the active treatment arm compared to placebo.|Mixed Models Analysis|||"A linear mixed model based on the mITT population was used. The model included fixed factors for treatment, time (measured in weeks), the interaction for treatment-by-time, baseline analgesic (Yes/No) and random effect for clinical site. Baseline WOMAC difficulty score was included as a covariate for adjustment.~An unstructured covariance matrix was used to model the covariance pattern in the mixed effects model."||2.72|-10.3|0.1262
72564104|NCT02960438|144659739|SUPERIORITY||Difference of arms|2.2||||0.374|TWO_SIDED|95.0|-19.96|24.46|||Regression, Logistic||Estimate was calculated based on the normal approximation to the binomial distribution.|||24.46|-19.96|0.374
72564105|NCT02960438|144659739|SUPERIORITY||Difference of arms|11.1||||0.102|TWO_SIDED|95.0|-7.42|29.64|||Regression, Logistic||Estimate was calculated based on the normal approximation to the binomial distribution.|||29.64|-7.42|0.102
72564106|NCT02960438|144659739|SUPERIORITY||Difference of arms|9.3||||0.188|TWO_SIDED|95.0|-9.25|27.77|||Regression, Logistic||Estimate was calculated based on the normal approximation to the binomial distribution.|||27.77|-9.25|0.188
72393995|NCT01059825|144294292|SUPERIORITY_OR_OTHER||Difference in least squares means|0.29||||0.602|TWO_SIDED|80.0|-1.13|1.7||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||1.70|-1.13|0.602
72465369|NCT02705625|144453466|SUPERIORITY|One model is fit for all comparison groups (MIV-711 200 mg, MIV-711 100 mg and placebo). This analysis reports the contrast that compares 200 mg versus placebo with respect to mean change from baseline in WOMAC stiffness score at Week 26.|Mean Difference (Final Values)|-3.07||||0.2|TWO_SIDED|95.0|-10.2|4.1||p-values reported are unadjusted p-values for tests of significance for the lower one-tailed alternative hypothesis Ha: Reduction in WOMAC Stiffness score is higher in the active treatment arm compared to placebo.|Mixed Models Analysis|||"A linear mixed model based on the mITT population was used. The model included fixed factors for treatment, time (measured in weeks), the interaction for treatment-by-time, baseline analgesic (Yes/No) and random effect for clinical site. Baseline WOMAC Stiffness score was included as a covariate for adjustment.~An unstructured covariance matrix was used to model the covariance pattern in the mixed effects model."||4.1|-10.2|0.2
72465370|NCT02705625|144453466|SUPERIORITY|One model is fit for all comparison groups (MIV-711 200 mg, MIV-711 100 mg and placebo). This analysis reports the contrast that compares 100 mg versus placebo with respect to mean change from baseline in WOMAC stiffness score at Week 26.|Mean Difference (Final Values)|-4.95||||0.0861|TWO_SIDED|95.0|-12.1|2.17||p-values reported are unadjusted p-values for tests of significance for the lower one-tailed alternative hypothesis Ha: Reduction in WOMAC Stiffness score is higher in the active treatment arm compared to placebo.|Mixed Models Analysis|||"A linear mixed model based on the mITT population was used. The model included fixed factors for treatment, time (measured in weeks), the interaction for treatment-by-time, baseline analgesic user (Yes/No), and random effect for clinical site. Baseline WOMAC stiffness score was included as a covariate for adjustment.~An unstructured covariance matrix was used to model the covariance pattern in the mixed effects model."||2.17|-12.1|0.0861
72465371|NCT02705625|144453467|SUPERIORITY|One model is fit for all comparison groups (MIV-711 200 mg, MIV-711 100 mg and placebo). This analysis reports the contrast that compares 200 mg versus placebo with respect to mean change from baseline in CTX-I score at Week 26.|Mean Difference (Final Values)|-0.254|||<|0.0001|TWO_SIDED|95.0|-0.302|-0.206||p-values reported are unadjusted p-values for tests of significance for the upper one-tailed alternative hypothesis Ha: CTX-I score is lower in the active treatment arm compared to placebo.|Mixed Models Analysis|||"A linear mixed model based on the mITT population was used. The model included fixed factors for treatment, time (measured in weeks), the interaction for treatment-by-time, baseline analgesic user (Yes/No), and random effect for clinical site. Baseline CTX-I score was included as a covariate for adjustment.~An unstructured covariance matrix was used to model the covariance pattern in the mixed effects model."||-0.206|-0.302|<0.0001
72465372|NCT02705625|144453467|SUPERIORITY|One model is fit for all comparison groups (MIV-711 200 mg, MIV-711 100 mg and placebo). This analysis reports the contrast that compares 100 mg versus placebo with respect to mean change from baseline in CTX-I score at Week 26.|Mean Difference (Final Values)|-0.145|||<|0.0001|TWO_SIDED|95.0|-0.193|-0.0983||p-values reported are unadjusted p-values for tests of significance for the upper one-tailed alternative hypothesis Ha: CTX-I score is lower in the active treatment arm compared to placebo.|Mixed Models Analysis|||"A linear mixed model based on the mITT population was used. The model included fixed factors for treatment, time (measured in weeks), the interaction for treatment-by-time, baseline analgesic user (Yes/No), and random effect for clinical site. Baseline CTX-I score was included as a covariate for adjustment.~An unstructured covariance matrix was used to model the covariance pattern in the mixed effects model."||-0.0983|-0.193|<0.0001
72465373|NCT02705625|144453468|SUPERIORITY|One model is fit for all comparison groups (MIV-711 200 mg, MIV-711 100 mg and placebo). This analysis reports the contrast that compares 200 mg versus placebo with respect to mean change from baseline in CTX-II score at Week 26.|Mean Difference (Final Values)|-270.0|||<|0.0001|TWO_SIDED|95.0|-339.0|-201.0||p-values reported are unadjusted p-values for tests of significance for the upper one-tailed alternative hypothesis Ha: CTX-II score is lower in the active treatment arm compared to placebo.|Mixed Models Analysis|||"A linear mixed model based on the mITT population was used. The model included fixed factors for treatment, time (measured in weeks), the interaction for treatment-by-time, baseline analgesic user (Yes/No), and random effect for clinical site. Baseline CTX-II score was included as a covariate for adjustment.~An unstructured covariance matrix was used to model the covariance pattern in the mixed effects model."||-201|-339|<0.0001
72502698|NCT01193335|144536052|SUPERIORITY_OR_OTHER||Percent difference|0.0|||||TWO_SIDED|95.0|-4.25|4.31||||||Serotype 19A: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.||4.31|-4.25|
72502699|NCT01193335|144536054|SUPERIORITY_OR_OTHER||GMC Ratio|0.76|||||TWO_SIDED|95.0|0.6|0.97||||||Serotype 4: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the ratio difference of the logarithms of the measures.||0.97|0.60|
72502700|NCT01193335|144536054|SUPERIORITY_OR_OTHER||GMC Ratio|0.51|||||TWO_SIDED|95.0|0.39|0.66||||||Serotype 6B: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||0.66|0.39|
72564107|NCT01316419|144659778|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Mean SBP change from baseline at the last visit will be analyzed by paired t-test|Paired t test|||||||<0.0001
72564108|NCT01316419|144659781|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Mean DBP change from baseline at the last visit will be analyzed by paired t-test|Paired t test|||||||<0.0001
72564109|NCT01316419|144659783|SUPERIORITY_OR_OTHER|||||||0.1099|TWO_SIDED|||||The change of QOL data collected using the WHOQOL-BREF is analyzed by paired t-test|Paired t test|||||||0.1099
72393996|NCT01059825|144294293|SUPERIORITY_OR_OTHER||Difference in least squares means|-2.2||||0.045|TWO_SIDED|80.0|-3.86|-0.54||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-0.54|-3.86|0.045
72621318|NCT02732145|144773192|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of Labia Minora among patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of non-specific lesions of Labia Minora in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of vulvodynia."||||0.0000
72465374|NCT02705625|144453468|SUPERIORITY|One model is fit for all comparison groups (MIV-711 200 mg, MIV-711 100 mg and placebo). This analysis reports the contrast that compares 100 mg versus placebo with respect to mean change from baseline in CTX-II score at Week 26.|Mean Difference (Final Values)|-193.0|||<|0.0001|TWO_SIDED|95.0|-262.0|-124.0||p-values reported are unadjusted p-values for tests of significance for the upper one-tailed alternative hypothesis Ha: CTX-II score is lower in the active treatment arm compared to placebo.|Mixed Models Analysis|||"A linear mixed model based on the mITT population was used. The model included fixed factors for treatment, time (measured in weeks), the interaction for treatment-by- time, baseline analgesic user (Yes/No), and random effect for clinical site. Baseline CTX-II score was included as a covariate for adjustment.~An unstructured covariance matrix was used to model the covariance pattern in the mixed effects model."||-124|-262|<0.0001
72465375|NCT00225277|144453501|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.886||||0.002||95.0|-1.448|-0.325|||ANCOVA||Mean Difference = Pioglitazone - Glimepiride|2 Way analysis of covariance (ANCOVA), treatment and center effects with baseline value as covariate. Least Squares (LS) mean change and LS mean of the treatment difference reported.||-0.3250|-1.4480|0.002
72465376|NCT00225277|144453502|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.048||||0.064||95.0|-8.3336|0.2374|||ANCOVA||Mean Difference = Pioglitazone - Glimepiride|2 Way ANCOVA, treatment and center effects with baseline value as covariate. LS mean of the treatment difference reported.||0.2374|-8.3336|0.064
72465377|NCT00225277|144453503|SUPERIORITY_OR_OTHER|||||||0.744||||||Kaplan-Meier methodology was used to estimate the time to event for each composite endpoint. The p-value was based on a log-rank test.|Log Rank|||||||0.744
72465378|NCT00225277|144453504|SUPERIORITY_OR_OTHER|||||||0.883||95.0||||Kaplan-Meier methodology was used to estimate the time to event for each composite endpoint. The p-value was based on a log-rank test.|Log Rank|||||||0.883
72465379|NCT00225277|144453505|SUPERIORITY_OR_OTHER|||||||0.663||95.0||||Kaplan-Meier methodology was used to estimate the time to event for each composite endpoint. The p-value was based on a log-rank test.|Log Rank|||||||0.663
72465380|NCT01182103|144453608|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||t-test, 2 sided|||||||<0.05
72465381|NCT01182103|144453609|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||t-test, 2 sided|||||||<0.05
72465382|NCT01182103|144453610|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||t-test, 2 sided|||||||<0.05
72465383|NCT01670188|144453611|SUPERIORITY|||||||0.02|||||||t-test, 2 sided|||||||0.02
72465384|NCT03455218|144453620|SUPERIORITY|||||||0.55|||||||t-test, 2 sided|||||||0.55
72465385|NCT03455218|144453622|SUPERIORITY|||||||0.3|||||||Wilcoxon (Mann-Whitney)|||||||0.30
72465386|NCT03455218|144453623|SUPERIORITY|||||||0.11|||||||t-test, 2 sided|||||||0.11
72465387|NCT03455218|144453624|SUPERIORITY|||||||0.002|||||||t-test, 2 sided|||||||0.002
72465388|NCT03455218|144453625|SUPERIORITY|||||||0.05|||||||t-test, 2 sided|||||||0.05
72465389|NCT03455218|144453626|SUPERIORITY|||||||0.27|||||||Wilcoxon (Mann-Whitney)|||||||0.27
72465390|NCT03455218|144453627|SUPERIORITY|||||||0.57|||||||Wilcoxon (Mann-Whitney)|||||||0.57
72465391|NCT03455218|144453629|SUPERIORITY|||||||0.48|||||||Wilcoxon (Mann-Whitney)|||||||0.48
72465392|NCT03455218|144453630|SUPERIORITY|||||||0.96|||||||Wilcoxon (Mann-Whitney)|||||||0.96
72465393|NCT03455218|144453631|SUPERIORITY|||||||0.71|||||||t-test, 2 sided|||||||0.71
72465394|NCT03455218|144453632|SUPERIORITY|||||||0.97|||||||Wilcoxon (Mann-Whitney)|||||||0.97
72465395|NCT03455218|144453633|SUPERIORITY|||||||0.53|||||||Wilcoxon (Mann-Whitney)|||||||0.53
72465396|NCT03455218|144453634|SUPERIORITY|||||||1|||||||Chi-squared|||||||1.0
72465397|NCT03455218|144453635|SUPERIORITY|||||||0.46|||||||Wilcoxon (Mann-Whitney)|||||||0.46
72465398|NCT00527514|144453643|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||No multiplicity adjustments|one-sample t-test|||The sample size of this study was not based on the statistical power consideration and was considered as sufficient for the evaluation of the efficacy and safety of the proposed olmesartan medoxomil-based treatment regimen.||||<0.0001
72502701|NCT01193335|144536054|SUPERIORITY_OR_OTHER||GMC Ratio|0.64|||||TWO_SIDED|95.0|0.51|0.8||||||Serotype 9V: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||0.80|0.51|
72502702|NCT01193335|144536054|SUPERIORITY_OR_OTHER||GMC Ratio|0.86|||||TWO_SIDED|95.0|0.66|1.12||||||Serotype 14: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the ratio difference of the logarithms of the measures.||1.12|0.66|
72502703|NCT01193335|144536054|SUPERIORITY_OR_OTHER||GMC Ratio|1.06|||||TWO_SIDED|95.0|0.85|1.32||||||Serotype 18C: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the ratio difference of the logarithms of the measures.||1.32|0.85|
72502704|NCT01193335|144536054|SUPERIORITY_OR_OTHER||GMC Ratio|0.73|||||TWO_SIDED|95.0|0.58|0.92||||||Serotype 19F: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the ratio difference of the logarithms of the measures.||0.92|0.58|
72502705|NCT01193335|144536054|SUPERIORITY_OR_OTHER||GMC Ratio|0.6|||||TWO_SIDED|95.0|0.43|0.83||||||Serotype 23F: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||0.83|0.43|
72502706|NCT01193335|144536054|SUPERIORITY_OR_OTHER||GMC Ratio|0.96|||||TWO_SIDED|95.0|0.77|1.2||||||Serotype 1: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||1.20|0.77|
72502707|NCT01193335|144536054|SUPERIORITY_OR_OTHER||GMC Ratio|0.6|||||TWO_SIDED|95.0|0.41|0.87||||||Serotype 3: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||0.87|0.41|
72502708|NCT01193335|144536054|SUPERIORITY_OR_OTHER||GMC Ratio|0.7|||||TWO_SIDED|95.0|0.56|0.88||||||Serotype 5: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||0.88|0.56|
72502709|NCT01193335|144536054|SUPERIORITY_OR_OTHER||GMC Ratio|0.54|||||TWO_SIDED|95.0|0.41|0.7||||||Serotype 6A: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||0.70|0.41|
72502710|NCT01193335|144536054|SUPERIORITY_OR_OTHER||GMC Ratio|0.86|||||TWO_SIDED|95.0|0.71|1.03||||||Serotype 7F: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||1.03|0.71|
72502711|NCT01193335|144536054|SUPERIORITY_OR_OTHER||GMC Ratio|0.55|||||TWO_SIDED|95.0|0.42|0.72||||||Serotype 19A: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||0.72|0.42|
72564110|NCT01316419|144659784|SUPERIORITY_OR_OTHER|||||||0.0197|TWO_SIDED|||||The change of QOL data collected using the WHOQOL-BREF is analyzed by paired t-test|Paired t test|||||||0.0197
72564111|NCT01316419|144659785|SUPERIORITY_OR_OTHER|||||||0.4543|TWO_SIDED|||||The change of QOL data collected using the WHOQOL-BREF is analyzed by paired t-test|Paired t test|||||||0.4543
72564112|NCT01316419|144659786|SUPERIORITY_OR_OTHER|||||||0.0152|TWO_SIDED|||||The change of QOL data collected using the WHOQOL-BREF is analyzed by paired t-test|Paired t test|||||||0.0152
72564113|NCT01316419|144659787|SUPERIORITY_OR_OTHER|||||||0.0013|TWO_SIDED|||||The change of QOL data collected using the WHOQOL-BREF is analyzed by paired t-test|Paired t test|||||||0.0013
72564114|NCT01316419|144659788|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||The change of QOL data collected using the EQ VAS is analyzed by paired t-test|Paired t test|||||||<0.0001
72564115|NCT01316419|144659790|SUPERIORITY_OR_OTHER|||||||0.0006|TWO_SIDED|||||Mean LDL-C change from baseline at the last visit will be analyzed by paired t-test|Paired t test|||||||0.0006
72564116|NCT01316419|144659791|SUPERIORITY_OR_OTHER|||||||0.4248|TWO_SIDED|||||Mean HDL-C change from baseline at the last visit will be analyzed by paired t-test|Paired t test|||||||0.4248
72564117|NCT01316419|144659792|SUPERIORITY_OR_OTHER|||||||0.5579|TWO_SIDED|||||Mean Triglyceride change from baseline at the last visit will be analyzed by paired t-test|Paired t test|||||||0.5579
72502712|NCT01193335|144536055|SUPERIORITY_OR_OTHER||GMC Ratio|0.65|||||TWO_SIDED|95.0|0.51|0.82||||||Serotype 4: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||0.82|0.51|
72502713|NCT01193335|144536055|SUPERIORITY_OR_OTHER||GMC Ratio|0.61|||||TWO_SIDED|95.0|0.47|0.79||||||Serotype 6B: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||0.79|0.47|
72502714|NCT01193335|144536055|SUPERIORITY_OR_OTHER||GMC Ratio|0.75|||||TWO_SIDED|95.0|0.61|0.93||||||Serotype 9V: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||0.93|0.61|
72502715|NCT01193335|144536055|SUPERIORITY_OR_OTHER||GMC Ratio|0.84|||||TWO_SIDED|95.0|0.66|1.07||||||Serotype 14: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||1.07|0.66|
72502716|NCT01193335|144536055|SUPERIORITY_OR_OTHER||GMC Ratio|0.84|||||TWO_SIDED|95.0|0.66|1.08||||||Serotype 18C: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||1.08|0.66|
72502717|NCT01193335|144536055|SUPERIORITY_OR_OTHER||GMC Ratio|0.63|||||TWO_SIDED|95.0|0.48|0.83||||||Serotype 19F: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||0.83|0.48|
72502718|NCT01193335|144536055|SUPERIORITY_OR_OTHER||GMC Ratio|0.61|||||TWO_SIDED|95.0|0.46|0.79||||||Serotype 23F: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||0.79|0.46|
72502719|NCT01193335|144536055|SUPERIORITY_OR_OTHER||GMC Ratio|0.81|||||TWO_SIDED|95.0|0.64|1.03||||||Serotype 1: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||1.03|0.64|
72564118|NCT01316419|144659793|SUPERIORITY_OR_OTHER|||||||0.0006|TWO_SIDED|||||Mean total cholesterol change from baseline at the last visit will be analyzed by paired t-test|Paired t-test|||||||0.0006
72502720|NCT01193335|144536055|SUPERIORITY_OR_OTHER||GMC Ratio|0.92|||||TWO_SIDED|95.0|0.73|1.15||||||Serotype 3: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||1.15|0.73|
72502721|NCT01193335|144536055|SUPERIORITY_OR_OTHER||GMC Ratio|0.71|||||TWO_SIDED|95.0|0.58|0.87||||||Serotype 5: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||0.87|0.58|
72502722|NCT01193335|144536055|SUPERIORITY_OR_OTHER||GMC Ratio|0.72|||||TWO_SIDED|95.0|0.57|0.9||||||Serotype 6A: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||0.90|0.57|
72502723|NCT01193335|144536055|SUPERIORITY_OR_OTHER||GMC Ratio|0.83|||||TWO_SIDED|95.0|0.69|1.0||||||Serotype 7F: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||1.00|0.69|
72465399|NCT00527514|144453644|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||No multiplicity adjustments|One-sample t-test|||Statistical analysis parameters apply to both the daytime and nighttime rows.||||<0.0001
72465400|NCT00527514|144453645|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||No multiplicity adjustments|One-sample t-test|||||||<0.0001
72465401|NCT00527514|144453646|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||No multiplicity adjustments|one-sample t-test|||||||<0.0001
72465402|NCT00527514|144453647|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||No multiplicity adjustments|One-sample t-test|||||||<0.0001
72502724|NCT01193335|144536055|SUPERIORITY_OR_OTHER||GMC Ratio|0.63|||||TWO_SIDED|95.0|0.49|0.81||||||Serotype 19A: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||0.81|0.49|
72564119|NCT00455962|144659808|SUPERIORITY|||||||0.69|||||||t-test, 2 sided|||Using previously collected data from a group of 18 predominantly Caucasian women undergoing a similar infusion we determined that 22 women would be necessary to identify a 30% difference in peak LH levels, the primary outcome measure, between AAW and CW with 80% power at a significance level of 0.05.||||0.69
72564120|NCT04039919|144659817|OTHER||Geometric LS Mean ratio|0.785|||||TWO_SIDED|90.0|0.6513|0.9461||||||The log-transformed PK parameters was analyzed by a mixed analysis of variance (ANOVA) with period and treatment as fixed effects and study participant as the random effect. The estimates and confidence intervals are back-transformed after the analysis.||0.9461|0.6513|
72465403|NCT00527514|144453648|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||No multiplicity adjustments|one-sample t-test|||||||<0.0001
72502725|NCT01193335|144536056|SUPERIORITY_OR_OTHER||GMC Ratio|0.81|||||TWO_SIDED|95.0|0.63|1.04||||||Serotype 4: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||1.04|0.63|
72502726|NCT01193335|144536056|SUPERIORITY_OR_OTHER||GMC Ratio|0.63|||||TWO_SIDED|95.0|0.48|0.83||||||Serotype 6B: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||0.83|0.48|
72502727|NCT01193335|144536056|SUPERIORITY_OR_OTHER||GMC Ratio|0.62|||||TWO_SIDED|95.0|0.46|0.84||||||Serotype 9V: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||0.84|0.46|
72502728|NCT01193335|144536056|SUPERIORITY_OR_OTHER||GMC Ratio|0.83|||||TWO_SIDED|95.0|0.61|1.12||||||Serotype 14: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||1.12|0.61|
72465404|NCT00812838|144453649|SUPERIORITY|||||||0.5154||||||This will be a pilot study; it was assessed that 10 subjects in each arm, for a total of 20 subjects, will allow us to determine if the therapy is effective. To allow for screen failures, 45 subjects are planned for screening.|t-test, 2 sided|||||||0.5154
72465405|NCT00812838|144453650|SUPERIORITY|||||||0.3009||||||This applies to 100 units of Botulinum Toxin Type A arm vs the Normal saline arm|t-test, 2 sided|||"This will be a pilot study; it was assessed that 10 subjects in each arm, for a total of 20 subjects, will allow us to determine if the therapy is effective. To allow for screen failures, 45 subjects are planned for screening.~This analysis pertains to both categories"||||0.3009
72465406|NCT00812838|144453651|SUPERIORITY|||||||0.0166||||||This applies to 100 units of Botulinum Toxin Type A arm vs the Normal saline arm|t-test, 2 sided|||This will be a pilot study; it was assessed that 10 subjects in each arm, for a total of 20 subjects, will allow us to determine if the therapy is effective. To allow for screen failures, 45 subjects are planned for screening.||||0.0166
72465407|NCT00812838|144453652|SUPERIORITY|||||||0.8566||||||Threshold for statistical significance was \<0.05|t-test, 2 sided|||This will be a pilot study; it was assessed that 10 subjects in each arm, for a total of 20 subjects, will allow us to determine if the therapy is effective. To allow for screen failures, 45 subjects are planned for screening.||||.8566
72502729|NCT01193335|144536056|SUPERIORITY_OR_OTHER||GMC Ratio|0.5|||||TWO_SIDED|95.0|0.37|0.67||||||Serotype 18C: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||0.67|0.37|
72502730|NCT01193335|144536056|SUPERIORITY_OR_OTHER||GMC Ratio|0.54|||||TWO_SIDED|95.0|0.4|0.72||||||Serotype 19F: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||0.72|0.40|
72393997|NCT01059825|144294293|SUPERIORITY_OR_OTHER||Difference in least squares means|-1.49||||0.126|TWO_SIDED|80.0|-3.16|0.18||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||0.18|-3.16|0.126
72393998|NCT01059825|144294293|SUPERIORITY_OR_OTHER||Difference in least squares means|-3.03||||0.011|TWO_SIDED|80.0|-4.72|-1.34||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-1.34|-4.72|0.011
72465408|NCT00812838|144453653|SUPERIORITY|||||||0.0286||||||Threshold for statistical significance is \<0.05|t-test, 2 sided|||This will be a pilot study; it was assessed that 10 subjects in each arm, for a total of 20 subjects, will allow us to determine if the therapy is effective. To allow for screen failures, 45 subjects are planned for screening.||||0.0286
72465409|NCT04148521|144453654|SUPERIORITY||Odds Ratio (OR)|1.15||||0.27|TWO_SIDED|95.0|0.9|1.47|||Mixed Models Analysis|||||1.47|0.90|0.27
72465410|NCT04148521|144453655|SUPERIORITY||Odds Ratio (OR)|1.04||||0.83|TWO_SIDED|95.0|0.75|1.43|||Mixed Models Analysis|||||1.43|0.75|0.83
72465411|NCT04148521|144453656|SUPERIORITY||Odds Ratio (OR)|1.43||||0.12|TWO_SIDED|95.0|0.91|2.26|||Mixed Models Analysis|||||2.26|0.91|0.12
72502731|NCT01193335|144536056|SUPERIORITY_OR_OTHER||GMC Ratio|0.47|||||TWO_SIDED|95.0|0.35|0.64||||||Serotype 23F: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||0.64|0.35|
72502732|NCT01193335|144536056|SUPERIORITY_OR_OTHER||GMC Ratio|0.76|||||TWO_SIDED|95.0|0.61|0.94||||||Serotype 1: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||0.94|0.61|
72502733|NCT01193335|144536056|SUPERIORITY_OR_OTHER||GMC Ratio|0.59|||||TWO_SIDED|95.0|0.39|0.9||||||Serotype 3: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||0.90|0.39|
72564121|NCT04039919|144659818|OTHER||Geometric LS Mean Ratio|0.8342|||||TWO_SIDED|90.0|0.6999|0.9942||||||The log-transformed PK parameters was analyzed by a mixed ANOVA with period and treatment as fixed effects and study participant as the random effect. The estimates and confidence intervals are back-transformed after the analysis.||0.9942|0.6999|
72465412|NCT04148521|144453657|SUPERIORITY||Odds Ratio (OR)|1.17||||0.51|TWO_SIDED|95.0|0.73|1.86|||Mixed Models Analysis|||||1.86|0.73|0.51
72465413|NCT01723514|144453678|SUPERIORITY||LS Geometric Mean Ratio|-79.33|||<|0.001|TWO_SIDED|95.0|-87.54|-65.73|||Repeated Measures ANCOVA|||Day 8: A repeated measures ANCOVA was performed for the ratio of blood flow measures at 30 minutes post capsaicin challenge to pre capsaicin challenge. The model included treatment, day, and the treatment by day interaction as independent variables, and both the 0 minute pre-capsaicin blood flow measure as well as the day 0, 30-minute post-capsaicin blood flow measures on day -1 .||-65.73|-87.54|< 0.001
72465414|NCT01723514|144453678|SUPERIORITY||LS Geometric Mean Ratio|-71.16|||<|0.001|TWO_SIDED|95.0|-82.67|-52.0|||Repeated Measures ANCOVA|||Day 8: A repeated measures ANCOVA was performed for the ratio of blood flow measures at 30 minutes post capsaicin challenge to pre capsaicin challenge. The model included treatment, day, and the treatment by day interaction as independent variables, and both the 0 minute pre-capsaicin blood flow measure as well as the day 0, 30-minute post-capsaicin blood flow measures on day -1 .||-52.00|-82.67|< 0.001
72502734|NCT01193335|144536056|SUPERIORITY_OR_OTHER||GMC Ratio|0.67|||||TWO_SIDED|95.0|0.52|0.87||||||Serotype 5: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||0.87|0.52|
72502735|NCT01193335|144536056|SUPERIORITY_OR_OTHER||GMC Ratio|0.68|||||TWO_SIDED|95.0|0.52|0.88||||||Serotype 6A: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||0.88|0.52|
72502736|NCT01193335|144536056|SUPERIORITY_OR_OTHER||GMC Ratio|0.82|||||TWO_SIDED|95.0|0.67|1.02||||||Serotype 7F: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||1.02|0.67|
72393999|NCT01059825|144294293|SUPERIORITY_OR_OTHER||Difference in least squares means|-1.99||||0.066|TWO_SIDED|80.0|-3.69|-0.3||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-0.30|-3.69|0.066
72394000|NCT01059825|144294293|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.48||||0.357|TWO_SIDED|80.0|-2.15|1.19||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||1.19|-2.15|0.357
72394001|NCT01059825|144294295|SUPERIORITY_OR_OTHER||Difference in least squares means|-20.99||||0|TWO_SIDED|80.0|-28.29|-13.69||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p \<0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-13.69|-28.29|0.000
72465415|NCT01723514|144453678|SUPERIORITY||LS Geometric Mean Ratio|-79.52|||<|0.001|TWO_SIDED|95.0|-88.29|-64.17|||Repeated Measures ANCOVA|||Day 8: A repeated measures ANCOVA was performed for the ratio of blood flow measures at 30 minutes post capsaicin challenge to pre capsaicin challenge. The model included treatment, day, and the treatment by day interaction as independent variables, and both the 0 minute pre-capsaicin blood flow measure as well as the day 0, 30-minute post-capsaicin blood flow measures on day -1 .||-64.17|-88.29|< 0.001
72502737|NCT01193335|144536056|SUPERIORITY_OR_OTHER||GMC Ratio|0.51|||||TWO_SIDED|95.0|0.36|0.72||||||Serotype 19A: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||0.72|0.36|
72465416|NCT01723514|144453678|SUPERIORITY||LS Geometric Mean Ratio|-72.34|||<|0.001|TWO_SIDED|95.0|-83.32|-54.13|||Repeated Measures ANCOVA|||Day 57: A repeated measures ANCOVA was performed for the ratio of blood flow measures at 30 minutes post capsaicin challenge to pre capsaicin challenge. The model included treatment, day, and the treatment by day interaction as independent variables, and both the 0 minute pre-capsaicin blood flow measure as well as the day 0, 30-minute post-capsaicin blood flow measures on day -1 .||-54.13|-83.32|< 0.001
72465417|NCT01723514|144453678|SUPERIORITY||LS Geometric Mean Ratio|-73.03|||<|0.001|TWO_SIDED|95.0|-83.79|-55.11|||Repeated Measures ANCOVA|||Day 57: A repeated measures ANCOVA was performed for the ratio of blood flow measures at 30 minutes post capsaicin challenge to pre capsaicin challenge. The model included treatment, day, and the treatment by day interaction as independent variables, and both the 0 minute pre-capsaicin blood flow measure as well as the day 0, 30-minute post-capsaicin blood flow measures on day -1 .||-55.11|-83.79|< 0.001
72502738|NCT01193335|144536057|SUPERIORITY_OR_OTHER||GMC Ratio|0.8|||||TWO_SIDED|95.0|0.61|1.03||||||Serotype 4: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||1.03|0.61|
72502739|NCT01193335|144536057|SUPERIORITY_OR_OTHER||GMC Ratio|0.53|||||TWO_SIDED|95.0|0.38|0.76||||||Serotype 6B: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||0.76|0.38|
72502740|NCT01193335|144536057|SUPERIORITY_OR_OTHER||GMC Ratio|0.74|||||TWO_SIDED|95.0|0.54|1.03||||||Serotype 9V: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||1.03|0.54|
72564122|NCT01197417|144659846|SUPERIORITY_OR_OTHER|||||||0.24|TWO_SIDED||||||Van Elteren test|Randomization strata were defined by enrollment site, age group and hydroxyurea use within the last three months prior to enrollment||Null hypothesis of equal distributions of primary length of stay between treatment arms within all randomization strata||||0.24
72564123|NCT01197417|144659847|SUPERIORITY_OR_OTHER|||||||0.12|TWO_SIDED||||||Van Elteren test|Randomization strata were defined by enrollment site, age group and hydroxyurea use within the last three months prior to enrollment.||||||0.12
72564124|NCT01197417|144659848|SUPERIORITY_OR_OTHER|||||||0.39|TWO_SIDED||||||Mantel Haenszel|Randomization strata were defined by enrollment site, age group and hydroxyurea use within the last three months prior to enrollment.||||||0.39
72564125|NCT01197417|144659849|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||Mantel Haenszel|Randomization strata were defined by enrollment site, age group and hydroxyurea use within the last three months prior to enrollment.||||||<0.01
72564126|NCT01197417|144659850|SUPERIORITY_OR_OTHER|||||||0.11|TWO_SIDED||||||Mantel Haenszel|Randomization strata were defined by enrollment site, age group and hydroxyurea use within the last three months prior to enrollment.||||||0.11
72564127|NCT01197417|144659851|SUPERIORITY_OR_OTHER|||||||0.78|TWO_SIDED||||||Van Elteren test|Randomization strata were defined by enrollment site, age group and hydroxyurea use within the last three months prior to enrollment.||||||0.78
72564128|NCT01197417|144659852|SUPERIORITY_OR_OTHER|||||||0.46|TWO_SIDED||||||Van Elteren test|Randomization strata were defined by enrollment site, age group and hydroxyurea use within the last three months prior to enrollment.||||||0.46
72621319|NCT02732145|144773192|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of the Posterior Commissure among patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of non-specific lesions of the Posterior Commissure in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy.. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of vulvodynia."||||0.0000
72465418|NCT01723514|144453678|SUPERIORITY||LS Geometric Mean Ratio|-71.88|||<|0.001|TWO_SIDED|95.0|-83.93|-50.82|||Repeated Measures ANCOVA|||Day 57: A repeated measures ANCOVA was performed for the ratio of blood flow measures at 30 minutes post capsaicin challenge to pre capsaicin challenge. The model included treatment, day, and the treatment by day interaction as independent variables, and both the 0 minute pre-capsaicin blood flow measure as well as the day 0, 30-minute post-capsaicin blood flow measures on day -1 .||-50.82|-83.93|< 0.001
72502741|NCT01193335|144536057|SUPERIORITY_OR_OTHER||GMC Ratio|0.77|||||TWO_SIDED|95.0|0.51|1.17||||||Serotype 14: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||1.17|0.51|
72502742|NCT01193335|144536057|SUPERIORITY_OR_OTHER||GMC Ratio|0.56|||||TWO_SIDED|95.0|0.4|0.78||||||Serotype 18C: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||0.78|0.40|
72502743|NCT01193335|144536057|SUPERIORITY_OR_OTHER||GMC Ratio|0.45|||||TWO_SIDED|95.0|0.29|0.71||||||Serotype 19F: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||0.71|0.29|
72502744|NCT01193335|144536057|SUPERIORITY_OR_OTHER||GMC Ratio|0.56|||||TWO_SIDED|95.0|0.38|0.83||||||Serotype 23F: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||0.83|0.38|
72502745|NCT01193335|144536057|SUPERIORITY_OR_OTHER||GMC Ratio|0.82|||||TWO_SIDED|95.0|0.63|1.07||||||Serotype 1: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||1.07|0.63|
72465419|NCT01723514|144453678|SUPERIORITY||LS Geometric Mean Ratio|-68.51|||<|0.001|TWO_SIDED|95.0|-81.01|-47.78|||Repeated Measures ANCOVA|||Day 85: A repeated measures ANCOVA was performed for the ratio of blood flow measures at 30 minutes post capsaicin challenge to pre capsaicin challenge. The model included treatment, day, and the treatment by day interaction as independent variables, and both the 0 minute pre-capsaicin blood flow measure as well as the day 0, 30-minute post-capsaicin blood flow measures on day -1 .||-47.78|-81.01|< 0.001
72465420|NCT01723514|144453678|SUPERIORITY||LS Geometric Mean Ratio|-81.06|||<|0.001|TWO_SIDED|95.0|-88.62|-68.49|||Repeated Measures ANCOVA|||Day 85: A repeated measures ANCOVA was performed for the ratio of blood flow measures at 30 minutes post capsaicin challenge to pre capsaicin challenge. The model included treatment, day, and the treatment by day interaction as independent variables, and both the 0 minute pre-capsaicin blood flow measure as well as the day 0, 30-minute post-capsaicin blood flow measures on day -1 .||-68.49|-88.62|< 0.001
72465421|NCT01723514|144453678|SUPERIORITY||LS Geometric Mean Ratio|-79.04|||<|0.001|TWO_SIDED|95.0|-88.02|-63.34|||Repeated Measures ANCOVA|||Day 85: A repeated measures ANCOVA was performed for the ratio of blood flow measures at 30 minutes post capsaicin challenge to pre capsaicin challenge. The model included treatment, day, and the treatment by day interaction as independent variables, and both the 0 minute pre-capsaicin blood flow measure as well as the day 0, 30-minute post-capsaicin blood flow measures on day -1 .||-63.34|-88.02|< 0.001
72465422|NCT01723514|144453678|SUPERIORITY||LS Geometric Mean Ratio|-32.7||||0.25|TWO_SIDED|95.0|-65.71|32.1|||Repeated Measures ANCOVA|||Day 113: A repeated measures ANCOVA was performed for the ratio of blood flow measures at 30 minutes post capsaicin challenge to pre capsaicin challenge. The model included treatment, day, and the treatment by day interaction as independent variables, and both the 0 minute pre-capsaicin blood flow measure as well as the day 0, 30-minute post-capsaicin blood flow measures on day -1 .||32.10|-65.71|0.25
72465423|NCT01723514|144453678|SUPERIORITY||LS Geometric Mean Ratio|3.44||||0.9|TWO_SIDED|95.0|-40.78|80.66|||Repeated Measures ANCOVA|||Day 169: A repeated measures ANCOVA was performed for the ratio of blood flow measures at 30 minutes post capsaicin challenge to pre capsaicin challenge. The model included treatment, day, and the treatment by day interaction as independent variables, and both the 0 minute pre-capsaicin blood flow measure as well as the day 0, 30-minute post-capsaicin blood flow measures on day -1 .||80.66|-40.78|0.90
72465424|NCT01723514|144453678|SUPERIORITY||LS Geometric Mean Ratio|-40.53||||0.091|TWO_SIDED|95.0|-67.5|8.82|||Repeated Measures ANCOVA|||Day 169: A repeated measures ANCOVA was performed for the ratio of blood flow measures at 30 minutes post capsaicin challenge to pre capsaicin challenge. The model included treatment, day, and the treatment by day interaction as independent variables, and both the 0 minute pre-capsaicin blood flow measure as well as the day 0, 30-minute post-capsaicin blood flow measures on day -1 .||8.82|-67.50|0.091
72465425|NCT01723514|144453678|SUPERIORITY||LS Geometric Mean Ratio|13.33||||0.73|TWO_SIDED|95.0|-44.39|130.94|||Repeated Measures ANCOVA|||Day 197: A repeated measures ANCOVA was performed for the ratio of blood flow measures at 30 minutes post capsaicin challenge to pre capsaicin challenge. The model included treatment, day, and the treatment by day interaction as independent variables, and both the 0 minute pre-capsaicin blood flow measure as well as the day 0, 30-minute post-capsaicin blood flow measures on day -1 .||130.94|-44.39|0.73
72465426|NCT01723514|144453678|SUPERIORITY||LS Geometric Mean Ratio|-80.02||||0.001|TWO_SIDED|95.0|-91.53|-52.87|||Repeated Measures ANCOVA|||Day 8: A repeated measures ANCOVA was performed for the ratio of blood flow measures at 30 minutes post capsaicin challenge to pre capsaicin challenge. The model included treatment, day, and the treatment by day interaction as independent variables, and both the 0 minute pre-capsaicin blood flow measure as well as the day 0, 30-minute post-capsaicin blood flow measures on day -1 .||-52.87|-91.53|0.001
72465427|NCT01723514|144453678|SUPERIORITY||LS Geometric Mean Ratio|-87.6|||<|0.001|TWO_SIDED|95.0|-94.53|-71.88|||Repeated Measures ANCOVA|||Day 8: A repeated measures ANCOVA was performed for the ratio of blood flow measures at 30 minutes post capsaicin challenge to pre capsaicin challenge. The model included treatment, day, and the treatment by day interaction as independent variables, and both the 0 minute pre-capsaicin blood flow measure as well as the day 0, 30-minute post-capsaicin blood flow measures on day -1 .||-71.88|-94.53|< 0.001
72465428|NCT01723514|144453678|SUPERIORITY||LS Geometric Mean Rratio|-79.81||||0.001|TWO_SIDED|95.0|-91.44|-52.37|||Repeated Measures ANCOVA|||Day 57: A repeated measures ANCOVA was performed for the ratio of blood flow measures at 30 minutes post capsaicin challenge to pre capsaicin challenge. The model included treatment, day, and the treatment by day interaction as independent variables, and both the 0 minute pre-capsaicin blood flow measure as well as the day 0, 30-minute post-capsaicin blood flow measures on day -1 .||-52.37|-91.44|0.001
72564129|NCT01311557|144659892|NON_INFERIORITY_OR_EQUIVALENCE|"A two-sided 95% confidence interval (CI) was constructed around each of the ratios: Pertussis toxoid (PT) GMT Group 1 / GMT Group 2.~The GMT hypothesis was supported by the data if the lower bound of the calculated 95% CI was \> 0.67. This was the equivalent of testing the null hypothesis using a one-sided type I error rate of 0.025."|GMT Ratio|0.94|||||TWO_SIDED|95.0|0.843|1.05||||||||1.05|0.843|
72564130|NCT01311557|144659892|NON_INFERIORITY_OR_EQUIVALENCE|"A two-sided 95% CI was constructed around each of the ratios: anti-Filamentous hemagglutinin (FHA) GMT Group 1 / GMT Group 2.~The GMT hypothesis was supported by the data if the lower bound of the calculated 95% CI was \> 0.67. This was the equivalent of testing the null hypothesis using a one-sided type I error rate of 0.025."|GMT Ratio|1.03|||||TWO_SIDED|95.0|0.944|1.13||||||||1.13|0.944|
72465429|NCT01723514|144453678|SUPERIORITY||LS Geometric Mean Ratio|-83.66|||<|0.001|TWO_SIDED|95.0|-92.79|-62.95|||Repeated Measures ANCOVA|||Day 57: A repeated measures ANCOVA was performed for the ratio of blood flow measures at 30 minutes post capsaicin challenge to pre capsaicin challenge. The model included treatment, day, and the treatment by day interaction as independent variables, and both the 0 minute pre-capsaicin blood flow measure as well as the day 0, 30-minute post-capsaicin blood flow measures on day -1 .||-62.95|-92.79|< 0.001
72564131|NCT01311557|144659892|NON_INFERIORITY_OR_EQUIVALENCE|"A two-sided 95% CI was constructed around each of the ratios: Anti-Pertactin (PRN) GMT Group 1 / GMT Group 2.~The GMT hypothesis was supported by the data if the lower bound of the calculated 95% CI was \> 0.67. This was the equivalent of testing the null hypothesis using a one-sided type I error rate of 0.025."|GMT Ratio|1.05|||||TWO_SIDED|95.0|0.928|1.18||||||||1.18|0.928|
72465430|NCT01723514|144453678|SUPERIORITY||LS Geometric Mean Ratio|-81.97|||<|0.001|TWO_SIDED|95.0|-92.35|-57.46|||Repeated Measures ANCOVA|||Day 85: A repeated measures ANCOVA was performed for the ratio of blood flow measures at 30 minutes post capsaicin challenge to pre capsaicin challenge. The model included treatment, day, and the treatment by day interaction as independent variables, and both the 0 minute pre-capsaicin blood flow measure as well as the day 0, 30-minute post-capsaicin blood flow measures on day -1 .||-57.46|-92.35|< 0.001
72465431|NCT01723514|144453678|SUPERIORITY||LS Geometric Mean Ratio|-84.39|||<|0.001|TWO_SIDED|95.0|-93.12|-64.6|||Repeated Measures ANCOVA|||Day 85: A repeated measures ANCOVA was performed for the ratio of blood flow measures at 30 minutes post capsaicin challenge to pre capsaicin challenge. The model included treatment, day, and the treatment by day interaction as independent variables, and both the 0 minute pre-capsaicin blood flow measure as well as the day 0, 30-minute post-capsaicin blood flow measures on day -1 .||-64.60|-93.12|< 0.001
72465432|NCT01723514|144453678|SUPERIORITY||LS Geometric Mean Ratio|43.1||||0.47|TWO_SIDED|95.0|-47.06|286.83|||Repeated Measures ANCOVA|||Day 113: A repeated measures ANCOVA was performed for the ratio of blood flow measures at 30 minutes post capsaicin challenge to pre capsaicin challenge. The model included treatment, day, and the treatment by day interaction as independent variables, and both the 0 minute pre-capsaicin blood flow measure as well as the day 0, 30-minute post-capsaicin blood flow measures on day -1 .||286.83|-47.06|0.47
72465433|NCT01723514|144453678|SUPERIORITY||LS Geometric Mean Ratio|-68.58||||0.02|TWO_SIDED|95.0|-88.02|-17.63|||Repeated Measures ANCOVA|||Day 169: A repeated measures ANCOVA was performed for the ratio of blood flow measures at 30 minutes post capsaicin challenge to pre capsaicin challenge. The model included treatment, day, and the treatment by day interaction as independent variables, and both the 0 minute pre-capsaicin blood flow measure as well as the day 0, 30-minute post-capsaicin blood flow measures on day -1 .||-17.63|-88.02|0.020
72465434|NCT01723514|144453678|SUPERIORITY||LS Geometric Mean Ratio|-54.32||||0.11|TWO_SIDED|95.0|-82.58|19.75|||Repeated Measures ANCOVA|||Day 197: A repeated measures ANCOVA was performed for the ratio of blood flow measures at 30 minutes post capsaicin challenge to pre capsaicin challenge. The model included treatment, day, and the treatment by day interaction as independent variables, and both the 0 minute pre-capsaicin blood flow measure as well as the day 0, 30-minute post-capsaicin blood flow measures on day -1 .||19.75|-82.58|0.11
72465435|NCT00014222|144453679|SUPERIORITY|||||||0.0007|||||||Log Rank|||||||0.0007
72465436|NCT00014222|144453680|SUPERIORITY|||||||0.084|||||||Log Rank|||||||0.084
72465437|NCT02970305|144453753|SUPERIORITY||Difference in MMRM LSMs|-1.9|STANDARD_ERROR_OF_MEAN|0.95||0.0434|TWO_SIDED|95.0|-3.8|-0.1|||Mixed-effects model for repeated measure|||||-0.1|-3.8|0.0434
72502746|NCT01193335|144536057|SUPERIORITY_OR_OTHER||GMC Ratio|0.66|||||TWO_SIDED|95.0|0.39|1.11||||||Serotype 3: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||1.11|0.39|
72502747|NCT01193335|144536057|SUPERIORITY_OR_OTHER||GMC Ratio|0.68|||||TWO_SIDED|95.0|0.5|0.92||||||Serotype 5: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||0.92|0.50|
72502748|NCT01193335|144536057|SUPERIORITY_OR_OTHER||GMC Ratio|0.67|||||TWO_SIDED|95.0|0.47|0.95||||||Serotype 6A: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||0.95|0.47|
72502749|NCT01193335|144536057|SUPERIORITY_OR_OTHER||GMC Ratio|0.89|||||TWO_SIDED|95.0|0.7|1.13||||||Serotype 7F: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||1.13|0.70|
72502750|NCT01193335|144536057|SUPERIORITY_OR_OTHER||GMC Ratio|0.53|||||TWO_SIDED|95.0|0.37|0.78||||||Serotype 19A: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||0.78|0.37|
72502751|NCT01193335|144536063|SUPERIORITY_OR_OTHER||GMT Ratio|1.3|||||TWO_SIDED|95.0|0.99|1.81||||||Serotype 4: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||1.81|0.99|
72502752|NCT01193335|144536063|SUPERIORITY_OR_OTHER||GMT Ratio|1.1|||||TWO_SIDED|95.0|0.59|2.2||||||Serotype 6B: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||2.20|0.59|
72564132|NCT01311557|144659892|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI was constructed around each of the ratios: anti-Fimbriae types 2 and 3 (FIM) GMT Group 1 / GMT Group 2. The GMT hypothesis was supported by the data if the lower bound of the calculated 95% CI was \> 0.67. This was the equivalent of testing the null hypothesis using a one-sided type I error rate of 0.025.|GMT Ratio|0.882|||||TWO_SIDED|95.0|0.731|1.06||||||||1.06|0.731|
72564133|NCT00572039|144659898|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.079||||0.47|TWO_SIDED|95.0|-0.14|0.29|||ANCOVA|||To test the efficacy of PST to improve TVF functional reserve measures at 3 months, we used an analysis of covariance in which group differences (PST vs ST) in 3-month average TVF scores were examined, adjusting for baseline TVF score and the vision severity stratification variable. To approximate an interval scale and compensate for ceiling and floor effects, we linearized TVF scores using a logit transform. 106 PST and 112 ST participants provided data at 3 months.||0.29|-0.14|.47
72564134|NCT00572039|144659899|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.4||||0.7|TWO_SIDED|95.0|-1.96|2.77|||ANCOVA|||To test the efficacy of PST to improve NE-VFQ scores at 3 months, we used an analysis of covariance in which group differences (PST vs ST) in 3-month average NEI-VFQ scores were examined, adjusting for baseline score and the vision severity stratification variable.||2.77|-1.96|.7
72465438|NCT00983892|144453766|SUPERIORITY_OR_OTHER||Slope|-1.56||||0.03|TWO_SIDED|95.0|-2.97|-0.15|||GEE|Adjusting for baseline symptom severity, caregiver type, week number, and cancer site.||||-0.15|-2.97|0.030
72465439|NCT01268098|144453800|SUPERIORITY_OR_OTHER_LEGACY||Treatment difference|5.0|||>|0.999|TWO_SIDED|95.0|-20.6|30.7||All hypothesis testings in this study were based on type I error of 0.05. Adjustment for multiplicity was not applied.|Fisher Exact|The 2-sided Fisher's Exact test was utilized to test for difference between the two dose arms.|The 2-sided asymptotic 95% confidence interval is based on normal approximation.|The null hypothesis corresponding to the primary efficacy endpoint is that the percentages of subjects who meet the endpoint criteria are the same for both dose arms. This sample size for this study was not based on the statistical considerations.||30.7|-20.6|>0.999
72465440|NCT01268098|144453801|SUPERIORITY_OR_OTHER_LEGACY|||||||0.258|TWO_SIDED||||||Fisher Exact|The 2-sided Fisher's Exact test was utilized to test for difference betweenthe two dose arms.||The null hypothesis corresponding to this endpoint is that the percentages of subjects who meet the endpoint criteria are the same for both dose arms.||||0.258
72465441|NCT01929876|144453806|SUPERIORITY_OR_OTHER||Ratio of least squares means|316.6|||||TWO_SIDED|90.0|268.1|374.0|||||LS means from analysis of variance (ANOVA), calculated by transforming the natural log means back to the linear scale (that is, geometric LS mean).|Ratio of Least squares (LS) means (Cobimetinib with Itraconazole/Cobimetinib alone) of natural log-transformed parameter (expressed as a percent).||374.0|268.1|
72465442|NCT01929876|144453807|SUPERIORITY_OR_OTHER||Ratio of LS means|672.3|||||TWO_SIDED|90.0|563.7|801.9|||||Ratio of LS means (Cobimetinib with Itraconazole/Cobimetinib alone) of natural log-transformed parameter (expressed as a percent). LS means from ANOVA, calculated by transforming the natural log means back to the linear scale.|Only participants with PK parameter data from both Period 1 Day 1 and Period 2 Day 4 (n=11) were included for statistical analyses.||801.9|563.7|
72465443|NCT01929876|144453809|SUPERIORITY_OR_OTHER||Ratio of LS means|583.9|||||TWO_SIDED|90.0|488.2|698.2|||||Ratio of LS means (Cobimetinib with Itraconazole/Cobimetinib alone) of natural log-transformed parameter (expressed as a percent). LS means from ANOVA, calculated by transforming the natural log means back to the linear scale.|||698.2|488.2|
72465444|NCT01222533|144453842|NON_INFERIORITY_OR_EQUIVALENCE|The standard bioequivalence range of 80 to 125% was pre-specified for Cmax,ss in order to assess the relative systemic exposure following inhalation of Tio R5 compared to Tio HH18. Bioequivalence was not used as a surrogate for efficacy.|Geometric mean ratio (percentage)|80.66|STANDARD_DEVIATION|43.4||0.4423||90.0|73.49|88.52||Maximum of two one-sided p-values for geometric mean ratio being outside interval 80 percent to 125 percent.|ANOVA||Standard deviation is actually the geometric coefficient of variation.|||88.52|73.49|0.4423
72465445|NCT01222533|144453843|NON_INFERIORITY_OR_EQUIVALENCE|The standard bioequivalence range of 80 to 125% was pre-specified for AUC0-6,ss in order to assess the relative systemic exposure following inhalation of Tio R5 compared to Tio HH18. Bioequivalence was not used as a surrogate for efficacy.|Geometric mean ratio (percentage)|75.99|STANDARD_DEVIATION|34.1||0.8683||90.0|70.44|81.98||Maximum of two one-sided p-values for geometric mean ratio being outside interval 80 percent to 125 percent.|ANOVA||Standard deviation is actually the geometric coefficient of variation.|||81.98|70.44|0.8683
72465446|NCT01222533|144453844|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.087|STANDARD_ERROR_OF_MEAN|0.014||||95.0|0.06|0.114|||||Tio R1.25-Placebo|||0.114|0.060|
72465447|NCT01222533|144453844|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.101|STANDARD_ERROR_OF_MEAN|0.014|<|0.0001||95.0|0.074|0.128|||ANOVA|Adjusted for sequence, patients within sequences, period and treatment.|Tio R2.5-Placebo|||0.128|0.074|<0.0001
72465448|NCT01222533|144453844|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.121|STANDARD_ERROR_OF_MEAN|0.014|<|0.0001||95.0|0.094|0.148|||ANOVA|Adjusted for sequence, patients within sequences, period and treatment.|Tio R5-Placebo|||0.148|0.094|<0.0001
72465449|NCT01222533|144453845|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.165|STANDARD_ERROR_OF_MEAN|0.012||||95.0|0.141|0.189|||||Tio R1.25-Placebo.|||0.189|0.141|
72465450|NCT01222533|144453845|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.185|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001||95.0|0.161|0.209|||ANOVA|Adjusted for sequence, patients within sequences, period and treatment.|Tio R2.5-Placebo|||0.209|0.161|<0.0001
72465451|NCT01222533|144453845|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.191|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001||95.0|0.167|0.216|||ANOVA|Adjusted for sequence, patients within sequences, period and treatment.|Tio R5-Placebo|||0.216|0.167|<0.0001
72502753|NCT01193335|144536063|SUPERIORITY_OR_OTHER||GMT Ratio|0.7|||||TWO_SIDED|95.0|0.26|1.93||||||Serotype 9V: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||1.93|0.26|
72465452|NCT01222533|144453846|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.155|STANDARD_ERROR_OF_MEAN|0.013||||95.0|0.13|0.18|||||Tio R1.25-Placebo|||0.180|0.130|
72465453|NCT01222533|144453846|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.18|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001||95.0|0.155|0.205|||ANOVA|Adjusted for sequence, patients within sequences, period and treatment.|Tio R2.5-Placebo|||0.205|0.155|<0.0001
72465454|NCT01222533|144453846|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.187|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001||95.0|0.162|0.211|||ANOVA|Adjusted for sequence, patients within sequences, period and treatment.|Tio R5-Placebo|||0.211|0.162|<0.0001
72465455|NCT01222533|144453847|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.138|STANDARD_ERROR_OF_MEAN|0.028||||95.0|0.083|0.194|||||Tio R1.25-Placebo|||0.194|0.083|
72465456|NCT01222533|144453847|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.188|STANDARD_ERROR_OF_MEAN|0.028|<|0.0001||95.0|0.133|0.244|||ANOVA|Adjusted for sequence, patients within sequences, period and treatment.|Tio R2.5-Placebo|||0.244|0.133|<0.0001
72465457|NCT01222533|144453847|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.236|STANDARD_ERROR_OF_MEAN|0.028|<|0.0001||95.0|0.18|0.292|||ANOVA|Adjusted for sequence, patients within sequences, period and treatment.|Tio R5-Placebo|||0.292|0.180|<0.0001
72465458|NCT01222533|144453848|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.283|STANDARD_ERROR_OF_MEAN|0.022||||95.0|0.241|0.326|||||Tio R1.25-Placebo|||0.326|0.241|
72502754|NCT01193335|144536063|SUPERIORITY_OR_OTHER||GMT Ratio|1.3|||||TWO_SIDED|95.0|0.8|1.98||||||Serotype 14: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||1.98|0.80|
72394002|NCT01059825|144294295|SUPERIORITY_OR_OTHER||Difference in least squares means|-25.82||||0|TWO_SIDED|80.0|-33.17|-18.47||P-value is one-sided.P-value is rounded to 3 decimals; therefore, p \<0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-18.47|-33.17|0.000
72465459|NCT01222533|144453848|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.319|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001||95.0|0.276|0.362|||ANOVA|Adjusted for sequence, patients within sequences, period and treatment.|Tio R2.5-Placebo|||0.362|0.276|<0.0001
72465460|NCT01222533|144453848|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.335|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001||95.0|0.292|0.378|||ANOVA|Adjusted for sequence, patients within sequences, period and treatment.|Tio R5-Placebo|||0.378|0.292|<0.0001
72465461|NCT01222533|144453849|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.281|STANDARD_ERROR_OF_MEAN|0.023||||95.0|0.236|0.325|||||Tio R1.25-Placebo|||0.325|0.236|
72465462|NCT01222533|144453849|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.324|STANDARD_ERROR_OF_MEAN|0.023|<|0.0001||95.0|0.279|0.369|||ANOVA|Adjusted for sequence, patients within sequences, period and treatment.|Tio R2.5-Placebo|||0.369|0.279|<0.0001
72465463|NCT01222533|144453849|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.339|STANDARD_ERROR_OF_MEAN|0.023|<|0.0001||95.0|0.294|0.384|||ANOVA|Adjusted for sequence, patients within sequences, period and treatment.|Tio R5-Placebo|||0.384|0.294|<0.0001
72465464|NCT00526097|144453876|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.3|STANDARD_ERROR_OF_MEAN|0.36|<|0.0001||95.0|2.6|4.0||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate||4.0|2.6|<0.0001
72465465|NCT00526097|144453877|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.3|STANDARD_ERROR_OF_MEAN|0.42|<|0.0001||95.0|3.5|5.2||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs)|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate||5.2|3.5|<0.0001
72465466|NCT00526097|144453878|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.5|STANDARD_ERROR_OF_MEAN|0.43|<|0.0001||95.0|2.7|4.3||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate||4.3|2.7|<0.0001
72502755|NCT01193335|144536063|SUPERIORITY_OR_OTHER||GMT Ratio|1.4|||||TWO_SIDED|95.0|1.01|2.0||||||Serotype 18C: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||2.00|1.01|
72465467|NCT00526097|144453879|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.8|STANDARD_ERROR_OF_MEAN|0.39|<|0.0001||95.0|2.0|3.6||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate||3.6|2.0|<0.0001
72465468|NCT00526097|144453880|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.6|STANDARD_ERROR_OF_MEAN|0.43|<|0.0001||95.0|1.8|3.4||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate||3.4|1.8|<0.0001
72465469|NCT00526097|144453881|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.9|STANDARD_ERROR_OF_MEAN|0.43|<|0.0001||95.0|4.1|5.8||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate||5.8|4.1|<0.0001
72502756|NCT01193335|144536063|SUPERIORITY_OR_OTHER||GMT Ratio|1.2|||||TWO_SIDED|95.0|0.82|1.89||||||Serotype 19F: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||1.89|0.82|
72502757|NCT01193335|144536063|SUPERIORITY_OR_OTHER||GMT Ratio|1.3|||||TWO_SIDED|95.0|0.8|1.99||||||Serotype 23F: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||1.99|0.80|
72502758|NCT01193335|144536063|SUPERIORITY_OR_OTHER||GMT Ratio|0.8|||||TWO_SIDED|95.0|0.56|1.15||||||Serotype 1: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||1.15|0.56|
72502759|NCT01193335|144536063|SUPERIORITY_OR_OTHER||GMT Ratio|1.1|||||TWO_SIDED|95.0|0.83|1.41||||||Serotype 3: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||1.41|0.83|
72502760|NCT01193335|144536063|SUPERIORITY_OR_OTHER||GMT Ratio|0.6|||||TWO_SIDED|95.0|0.36|0.94||||||Serotype 5: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||0.94|0.36|
72394003|NCT01059825|144294295|SUPERIORITY_OR_OTHER||Difference in least squares means|-34.23||||0|TWO_SIDED|80.0|-41.64|-26.83||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p \<0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-26.83|-41.64|0.000
72465470|NCT00526097|144453882|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.7|STANDARD_ERROR_OF_MEAN|0.49|<|0.0001||95.0|5.8|7.7||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate||7.7|5.8|<0.0001
72502761|NCT01193335|144536063|SUPERIORITY_OR_OTHER||GMT Ratio|1.2|||||TWO_SIDED|95.0|0.88|1.68||||||Serotype 6A: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||1.68|0.88|
72502762|NCT01193335|144536063|SUPERIORITY_OR_OTHER||GMT Ratio|1.0|||||TWO_SIDED|95.0|0.78|1.39||||||Serotype 7F: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||1.39|0.78|
72502763|NCT01193335|144536063|SUPERIORITY_OR_OTHER||GMT Ratio|1.2|||||TWO_SIDED|95.0|0.89|1.51||||||Serotype 19A: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||1.51|0.89|
72502764|NCT01193335|144536064|SUPERIORITY_OR_OTHER||GMT Ratio|0.7|||||TWO_SIDED|95.0|0.37|1.44||||||Serotype 4: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||1.44|0.37|
72564135|NCT03852524|144659902|SUPERIORITY||Median Difference (Net)|11.0||||0.81|TWO_SIDED||||||Log Rank|||The sample size (41 patients per study group; 82 patients total) for this superiority trial was calculated with a power of 90% (alpha = 0.05) and based on the assumption that 50% of subjects in the placebo group would experience a bowel movement by postoperative day 3, as compared to 85% in the treatment group. Additionally, a 10% lost-to-follow up rate was assumed.||||0.81
72564136|NCT03478865|144659906|SUPERIORITY||Mean Difference (Final Values)|-2.54||||0.259|TWO_SIDED|95.0|-7.91|2.83||Result of statistical analyses were considered significant if the p-value from the two-sided test was \<0.05. No adjustments for multiplicity were made.|Student's paired t-test||The estimate was the difference in mean change in RIT between baseline and the treatment completion visit.|"Analysis: Student's paired t-test on study eyes alone at a two-sided Type I error rate of 5%.~Null hypothesis: the mean RIT at Baseline = the mean RIT at the treatment completion visit (Month 2 for Cohort 1)."||2.83|-7.91|0.259
72564137|NCT03478865|144659906|SUPERIORITY||Mean Difference (Final Values)|-0.27||||0.818|TWO_SIDED|95.0|-4.66|4.12||Result of statistical analyses were considered significant if the p-value from the two-sided test was \<0.05. No adjustments for multiplicity were made.|Student's paired t-test||The estimate was the difference in mean change in RIT between baseline and the treatment completion visit.|"Analysis: Student's paired t-test on study eyes alone at a two-sided Type I error rate of 5%.~Null hypothesis: the mean RIT at Baseline = the mean RIT at the treatment completion visit (Month 1 for Cohort 2)."||4.12|-4.66|0.818
72564138|NCT03478865|144659907|SUPERIORITY||Mean Difference (Final Values)|-3.56||||0.365|TWO_SIDED|95.0|-13.24|6.12||Result of statistical analyses were considered significant if the p-value from the two-sided test was \<0.05. No adjustments for multiplicity were made.|Student's paired t-test||The estimate was the difference in mean change in RIT between baseline and the post-treatment follow-up visit.|"Analysis: Student's paired t-test on study eyes alone at a two-sided Type I error rate of 5%.~Null hypothesis: the mean RIT at Baseline = the mean RIT at the post-treatment follow-up visit (Month 3 for Cohort 1)."||6.12|-13.24|0.365
72564139|NCT03478865|144659907|SUPERIORITY||Mean Difference (Final Values)|3.23||||0.48|TWO_SIDED|95.0|-12.94|19.41||Result of statistical analyses were considered significant if the p-value from the two-sided test was \<0.05. No adjustments for multiplicity were made.|Student's paired t-test||The estimate was the difference in mean change in RIT between baseline and the post-treatment follow-up visit.|"Analysis: Student's paired t-test on study eyes alone at a two-sided Type I error rate of 5%.~Null hypothesis: the mean RIT at Baseline = the mean RIT at the post-treatment follow-up visit (Month 2 for Cohort 2)."||19.41|-12.94|0.480
72564140|NCT02418455|144659916|SUPERIORITY||LS Mean|-61.0|STANDARD_ERROR_OF_MEAN|6.409|<|0.0001|TWO_SIDED|95.0|-73.56|-48.44||P-values are from generalized estimating equation (GEE) model including baseline value and visit as a categorical variable. The covariance structure within subjects is assumed to be exchangeable.|GEE model|||||-48.44|-73.56|< 0.0001
72564141|NCT02418455|144659924|SUPERIORITY|||||||0.2655|||||||t-test|||||||0.2655
72502765|NCT01193335|144536064|SUPERIORITY_OR_OTHER||GMT Ratio|0.8|||||TWO_SIDED|95.0|0.37|1.71||||||Serotype 6B: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||1.71|0.37|
72502766|NCT01193335|144536064|SUPERIORITY_OR_OTHER||GMT Ratio|1.5|||||TWO_SIDED|95.0|0.76|3.12||||||Serotype 9V: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||3.12|0.76|
72502767|NCT01193335|144536064|SUPERIORITY_OR_OTHER||GMT Ratio|0.6|||||TWO_SIDED|95.0|0.33|1.17||||||Serotype 14: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||1.17|0.33|
72502768|NCT01193335|144536064|SUPERIORITY_OR_OTHER||GMT Ratio|0.6|||||TWO_SIDED|95.0|0.24|1.55||||||Serotype 18C: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||1.55|0.24|
72465471|NCT00526097|144453883|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.7|STANDARD_ERROR_OF_MEAN|0.46|<|0.0001||95.0|3.8|5.6||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate||5.6|3.8|<0.0001
72502769|NCT01193335|144536064|SUPERIORITY_OR_OTHER||GMT Ratio|1.3|||||TWO_SIDED|95.0|0.97|1.77||||||Serotype 19F: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||1.77|0.97|
72502770|NCT01193335|144536064|SUPERIORITY_OR_OTHER||GMT Ratio|0.7|||||TWO_SIDED|95.0|0.35|1.46||||||Serotype 23F: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||1.46|0.35|
72502771|NCT01193335|144536064|SUPERIORITY_OR_OTHER||GMT Ratio|1.3|||||TWO_SIDED|95.0|1.0|1.6||||||Serotype 1: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||1.60|1.00|
72465472|NCT00526097|144453884|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.8|STANDARD_ERROR_OF_MEAN|0.45|<|0.0001||95.0|2.9|4.7||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate||4.7|2.9|<0.0001
72465473|NCT00526097|144453885|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.7|STANDARD_ERROR_OF_MEAN|0.43|<|0.0001||95.0|2.9|4.6||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate||4.6|2.9|<0.0001
72465474|NCT00526097|144453886|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Log Rank|||The log-rank test was used to calculate the p-value and to test for differences between the treatment groups.||||<0.0001
72564142|NCT02418455|144659925|SUPERIORITY||LS Mean|-0.99|STANDARD_ERROR_OF_MEAN|0.396||0.0122|TWO_SIDED|95.0|-1.77|-0.22||From generalized estimating equation model including baseline value and visit as a categorical variable. Change from baseline in Liver Ultrasound (cm) as a dependent variable. Covariance structure within subjects is assumed to be exchangeable.|generalized estimating equation|||Change at Week 12||-0.22|-1.77|0.0122
72564143|NCT02418455|144659925|SUPERIORITY||LS Mean|-1.21|STANDARD_ERROR_OF_MEAN|0.461||0.0086|TWO_SIDED|95.0|-2.12|-0.31||From generalized estimating equation model including baseline value and visit as a categorical variable. Change from baseline in Liver Ultrasound (cm) as a dependent variable. Covariance structure within subjects is assumed to be exchangeable.|generalized estimating equation|||Change at Week 24||-0.31|-2.12|0.0086
72564144|NCT02418455|144659925|SUPERIORITY||LS Mean|-0.98|STANDARD_ERROR_OF_MEAN|0.31||0.0016|TWO_SIDED|95.0|-1.58|-0.37||From generalized estimating equation model including baseline value and visit as a categorical variable. Change from baseline in Liver Ultrasound (cm) as a dependent variable. Covariance structure within subjects is assumed to be exchangeable.|generalized estimating equation|||Change at Week 48||-0.37|-1.58|0.0016
72564145|NCT02418455|144659925|SUPERIORITY||LS Mean|-0.57|STANDARD_ERROR_OF_MEAN|0.428||0.1792|TWO_SIDED|95.0|-1.41|0.26||From generalized estimating equation model including baseline value and visit as a categorical variable. Change from baseline in Liver Ultrasound (cm) as a dependent variable. Covariance structure within subjects is assumed to be exchangeable.|generalized estimating equation|||Change at Week 96||0.26|-1.41|0.1792
72465475|NCT00526097|144453887|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.04|||<|0.0001||95.0|1.62|2.57|||Fisher Exact||OR: Bisacodyl / Placebo; The exact 95% confidence interval (CI) by Clopper and Pearson is presented|||2.57|1.62|<0.0001
72465476|NCT00526097|144453888|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.75|||<|0.0001||95.0|1.44|2.13|||Fisher Exact||OR: Bisacodyl / Placebo; The exact 95% confidence interval (CI) by Clopper and Pearson is presented|||2.13|1.44|<0.0001
72465477|NCT00526097|144453889|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.08|||<|0.0001||95.0|1.62|2.66|||Fisher Exact||OR: Bisacodyl / Placebo; The exact 95% confidence interval (CI) by Clopper and Pearson is presented|||2.66|1.62|<0.0001
72465478|NCT00526097|144453890|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.7|||<|0.0001||95.0|1.37|2.11|||Fisher Exact||OR: Bisacodyl / Placebo; The exact 95% confidence interval (CI) by Clopper and Pearson is presented|||2.11|1.37|<0.0001
72465479|NCT00526097|144453891|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.52|||<|0.0001||95.0|1.24|1.88|||Fisher Exact||OR: Bisacodyl / Placebo; The exact 95% confidence interval (CI) by Clopper and Pearson is presented|||1.88|1.24|<0.0001
72465480|NCT00526097|144453892|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|17.13|||<|0.0001||95.0|4.28|68.66|||Fisher Exact||OR: Bisacodyl / Placebo; The exact 95% confidence interval (CI) by Clopper and Pearson is presented|||68.66|4.28|<0.0001
72502772|NCT01193335|144536064|SUPERIORITY_OR_OTHER||GMT Ratio|1.0|||||TWO_SIDED|95.0|0.68|1.33||||||Serotype 3: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||1.33|0.68|
72502773|NCT01193335|144536064|SUPERIORITY_OR_OTHER||GMT Ratio|1.0|||||TWO_SIDED|95.0|0.82|1.31||||||Serotype 5: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||1.31|0.82|
72502774|NCT01193335|144536064|SUPERIORITY_OR_OTHER||GMT Ratio|0.5|||||TWO_SIDED|95.0|0.24|1.04||||||Serotype 6A: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||1.04|0.24|
72465481|NCT00526097|144453893|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.46|||<|0.0001||95.0|1.81|3.35|||Fisher Exact||OR: Bisacodyl / Placebo; The exact 95% confidence interval (CI) by Clopper and Pearson is presented|||3.35|1.81|<0.0001
72564146|NCT02418455|144659925|SUPERIORITY||LS Mean|-0.35|STANDARD_ERROR_OF_MEAN|0.255||0.1731|TWO_SIDED|95.0|-0.85|0.15||From generalized estimating equation model including baseline value and visit as a categorical variable. Change from baseline in Liver Ultrasound (cm) as a dependent variable. Covariance structure within subjects is assumed to be exchangeable.|generalized estimating equation|||Change at Week 144||0.15|-0.85|0.1731
72564147|NCT02418455|144659926|SUPERIORITY||LS Mean|-0.37|STANDARD_ERROR_OF_MEAN|0.213||0.0843|TWO_SIDED|95.0|-0.78|0.05||From generalized estimating equation model including baseline value and visit as a categorical variable. Change from baseline in Liver Ultrasound (cm) as a dependent variable. Covariance structure within subjects is assumed to be exchangeable.|generalized estimating equation|||Change at Week 12||0.05|-0.78|0.0843
72465482|NCT00526097|144453894|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.5||||0.0025||95.0|1.32|4.74|||Fisher Exact||OR: Bisacodyl / Placebo; The exact 95% confidence interval (CI) by Clopper and Pearson is presented|||4.74|1.32|0.0025
72465483|NCT00526097|144453895|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.08||||0.0105||95.0|1.26|13.24|||Fisher Exact||OR: Bisacodyl / Placebo; The exact 95% confidence interval (CI) by Clopper and Pearson is presented|||13.24|1.26|0.0105
72465484|NCT00526097|144453896|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.84||||0.4002||95.0|0.52|6.47|||Fisher Exact||OR: Bisacodyl / Placebo; The exact 95% confidence interval (CI) by Clopper and Pearson is presented|||6.47|0.52|0.4002
72465485|NCT00526097|144453897|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.19||||1||95.0|0.37|3.77|||Fisher Exact||OR: Bisacodyl / Placebo; The exact 95% confidence interval (CI) by Clopper and Pearson is presented|||3.77|0.37|1.0000
72465486|NCT00526097|144453898|SUPERIORITY_OR_OTHER|||||||0.0951|||||||Fisher Exact|||||||0.0951
72465487|NCT00526097|144453899|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.19|||<|0.0001||95.0|0.09|0.41|||Fisher Exact||OR: Bisacodyl / Placebo; The exact 95% confidence interval (CI) by Clopper and Pearson is presented|||0.41|0.09|<0.0001
72465488|NCT00526097|144453900|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.24||||0.2524||95.0|0.02|2.67|||Fisher Exact||OR: Bisacodyl / Placebo; The exact 95% confidence interval (CI) by Clopper and Pearson is presented|||2.67|0.02|0.2524
72465489|NCT00526097|144453901|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.2||||0.0035||95.0|0.06|0.63|||Fisher Exact||OR: Bisacodyl / Placebo; The exact 95% confidence interval (CI) by Clopper and Pearson is presented|||0.63|0.06|0.0035
72465490|NCT00526097|144453902|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.06||||0.0004||95.0|0.01|0.46|||Fisher Exact||OR: Bisacodyl / Placebo; The exact 95% confidence interval (CI) by Clopper and Pearson is presented|||0.46|0.01|0.0004
72465491|NCT00526097|144453903|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.27||||0.0086||95.0|0.1|0.69|||Fisher Exact||OR: Bisacodyl / Placebo; The exact 95% confidence interval (CI) by Clopper and Pearson is presented|||0.69|0.10|0.0086
72465492|NCT00526097|144453904|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0|STANDARD_ERROR_OF_MEAN|0.08|<|0.0001||95.0|-1.2|-0.9||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate||-0.9|-1.2|<0.0001
72465493|NCT00526097|144453905|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001||95.0|-1.2|-0.8||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate||-0.8|-1.2|<0.0001
72465494|NCT00526097|144453906|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001||95.0|-1.1|-0.8||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate||-0.8|-1.1|<0.0001
72465495|NCT00526097|144453907|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001||95.0|-0.9|-0.5||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate||-0.5|-0.9|<0.0001
72465496|NCT00526097|144453908|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.6|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001||95.0|2.4|2.9||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate||2.9|2.4|<0.0001
72465497|NCT00526097|144453909|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.4|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001||95.0|2.1|2.7||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate||2.7|2.1|<0.0001
72465498|NCT00526097|144453910|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.3|STANDARD_ERROR_OF_MEAN|0.15|<|0.0001||95.0|2.0|2.5||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate||2.5|2.0|<0.0001
72465499|NCT00526097|144453911|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.0|STANDARD_ERROR_OF_MEAN|0.16|<|0.0001||95.0|1.7|2.3||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate||2.3|1.7|<0.0001
72564148|NCT02418455|144659926|SUPERIORITY||LS Mean|-0.02|STANDARD_ERROR_OF_MEAN|0.513||0.9618|TWO_SIDED|95.0|-1.03|0.98||From generalized estimating equation model including baseline value and visit as a categorical variable. Change from baseline in Liver Ultrasound (cm) as a dependent variable. Covariance structure within subjects is assumed to be exchangeable.|generalized estimating equation|||Change at Week 24||0.98|-1.03|0.9618
72564149|NCT02418455|144659926|SUPERIORITY||LS Mean|-0.15|STANDARD_ERROR_OF_MEAN|0.391||0.6954|TWO_SIDED|95.0|-0.92|0.61||From generalized estimating equation model including baseline value and visit as a categorical variable. Change from baseline in Liver Ultrasound (cm) as a dependent variable. Covariance structure within subjects is assumed to be exchangeable.|GEE model|||Change at Week 48||0.61|-0.92|0.6954
72564150|NCT02418455|144659926|SUPERIORITY||LS Mean|0.22|STANDARD_ERROR_OF_MEAN|0.364||0.5492|TWO_SIDED|95.0|-0.5|0.93||From generalized estimating equation model including baseline value and visit as a categorical variable. Change from baseline in Liver Ultrasound (cm) as a dependent variable. Covariance structure within subjects is assumed to be exchangeable.|generalized estimating equation|||Change at Week 96||0.93|-0.50|0.5492
72465500|NCT00526097|144453912|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.05||0.0002||95.0|-0.3|-0.1||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate||-0.1|-0.3|0.0002
72465501|NCT00526097|144453913|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.05||0.0003||95.0|-0.3|-0.1||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate||-0.1|-0.3|0.0003
72465502|NCT00526097|144453914|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.06||0.0127||95.0|-0.2|0.0||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate||-0.0|-0.2|0.0127
72465503|NCT00526097|144453915|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.06||0.0064||95.0|-0.3|0.0||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate||-0.0|-0.3|0.0064
72465504|NCT00526097|144453916|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|0.08|<|0.0001||95.0|-0.9|-0.6||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate||-0.6|-0.9|<0.0001
72465505|NCT00526097|144453917|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001||95.0|-1.0|-0.6||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate||-0.6|-1.0|<0.0001
72465506|NCT00526097|144453918|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001||95.0|-0.9|-0.5||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate||-0.5|-0.9|<0.0001
72465507|NCT00526097|144453919|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001||95.0|-0.8|-0.5||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate||-0.5|-0.8|<0.0001
72465508|NCT00526097|144453920|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.03|<|0.0001||95.0|-0.2|-0.1||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate||-0.1|-0.2|<0.0001
72465509|NCT00526097|144453921|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.04|<|0.0001||95.0|-0.3|-0.1||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate||-0.1|-0.3|<0.0001
72465510|NCT00526097|144453922|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.04|<|0.0001||95.0|-0.2|-0.1||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate||-0.1|-0.2|<0.0001
72465511|NCT00526097|144453923|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.04||0.0018||95.0|-0.2|0.0||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate||-0.0|-0.2|0.0018
72465512|NCT00526097|144453924|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for baseline||||||<0.0001
72465513|NCT00526097|144453925|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for baseline||||||<0.0001
72465514|NCT00526097|144453926|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for baseline||||||<0.0001
72465515|NCT00526097|144453927|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for baseline||||||<0.0001
72465516|NCT00526097|144453928|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for baseline||||||<0.0001
72465517|NCT00526097|144453929|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for baseline||||||<0.0001
72465518|NCT00526097|144453930|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for baseline||||||<0.0001
72465519|NCT00526097|144453931|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for baseline||||||<0.0001
72465520|NCT00526097|144453932|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for baseline||||||<0.0001
72465521|NCT00526097|144453933|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for baseline||||||<0.0001
72465522|NCT00526097|144453934|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for baseline||||||<0.0001
72465523|NCT00526097|144453935|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for baseline||||||<0.0001
72465524|NCT00526097|144453936|SUPERIORITY_OR_OTHER|||||||0.6773|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for baseline||||||0.6773
72465525|NCT00526097|144453937|SUPERIORITY_OR_OTHER|||||||0.0002|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for baseline||||||0.0002
72465526|NCT00526097|144453938|SUPERIORITY_OR_OTHER|||||||0.0001|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for baseline||||||0.0001
72465527|NCT00526097|144453939|SUPERIORITY_OR_OTHER|||||||0.0005|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for baseline||||||0.0005
72465528|NCT00526097|144453940|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Exact p-value|Wilcoxon rank sum test|||||||<0.0001
72465529|NCT00526097|144453941|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Exact p-value|Wilcoxon rank sum test|||||||<0.0001
72465530|NCT00526097|144453942|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Exact p-value|Wilcoxon rank sum test|||||||<0.0001
72465531|NCT00526097|144453943|SUPERIORITY_OR_OTHER|||||||0.0058||||||Exact p-value|Wilcoxon rank sum test|||||||0.0058
72465532|NCT00526097|144453944|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.5|STANDARD_ERROR_OF_MEAN|2.01||0.798||95.0|-3.4|4.5||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate||4.5|-3.4|0.7980
72502775|NCT01193335|144536064|SUPERIORITY_OR_OTHER||GMT Ratio|1.2|||||TWO_SIDED|95.0|0.58|2.53||||||Serotype 7F: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||2.53|0.58|
72502776|NCT01193335|144536064|SUPERIORITY_OR_OTHER||GMT Ratio|0.8|||||TWO_SIDED|95.0|0.52|1.37||||||Serotype 19A: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||1.37|0.52|
72502777|NCT01193335|144536065|SUPERIORITY_OR_OTHER||GMT Ratio|0.7|||||TWO_SIDED|95.0|0.45|0.97||||||Serotype 4: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||0.97|0.45|
72502778|NCT01193335|144536065|SUPERIORITY_OR_OTHER||GMT Ratio|0.9|||||TWO_SIDED|95.0|0.54|1.4||||||Serotype 6B: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||1.40|0.54|
72465533|NCT00526097|144453945|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.0|STANDARD_ERROR_OF_MEAN|2.05||0.6129||95.0|-3.0|5.1||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate||5.1|-3.0|0.6129
72465534|NCT00526097|144453946|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.1|STANDARD_ERROR_OF_MEAN|2.31||0.3567||95.0|-2.4|6.7||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate||6.7|-2.4|0.3567
72465535|NCT00526097|144453947|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.0|STANDARD_ERROR_OF_MEAN|1.34||0.1407||95.0|-0.7|4.6||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate||4.6|-0.7|0.1407
72465536|NCT00526097|144453948|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.3|STANDARD_ERROR_OF_MEAN|1.74||0.013||95.0|0.9|7.7||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate||7.7|0.9|0.0130
72465537|NCT00526097|144453949|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.2|STANDARD_ERROR_OF_MEAN|2.14||0.5849||95.0|-3.0|5.3||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate||5.3|-3.0|0.5849
72502779|NCT01193335|144536065|SUPERIORITY_OR_OTHER||GMT Ratio|0.7|||||TWO_SIDED|95.0|0.41|1.31||||||Serotype 9V: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||1.31|0.41|
72502780|NCT01193335|144536065|SUPERIORITY_OR_OTHER||GMT Ratio|0.8|||||TWO_SIDED|95.0|0.54|1.14||||||Serotype 14: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||1.14|0.54|
72502781|NCT01193335|144536065|SUPERIORITY_OR_OTHER||GMT Ratio|0.5|||||TWO_SIDED|95.0|0.34|0.87||||||Serotype 18C: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||0.87|0.34|
72502782|NCT01193335|144536065|SUPERIORITY_OR_OTHER||GMT Ratio|0.6|||||TWO_SIDED|95.0|0.31|1.1||||||Serotype 19F: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||1.10|0.31|
72621320|NCT02732145|144773192|SUPERIORITY|Question: Is there a difference in the incidence of erythema of the Anterior Commissure among patients from different groups?||||||0.0199|||||||Chi-squared|||"Parameter: The incidence of erythema of the Anterior Commissure in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q- Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of vulvodynia."||||0.0199
72621321|NCT02732145|144773192|SUPERIORITY|Question: Is there a difference in the incidence of erythema of Interlabial Sulci among patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of erythema of Interlabial Sulci in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q- Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of vulvodynia."||||0.0000
72502783|NCT01193335|144536065|SUPERIORITY_OR_OTHER||GMT Ratio|0.6|||||TWO_SIDED|95.0|0.4|1.01||||||Serotype 23F: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||1.01|0.40|
72502784|NCT01193335|144536065|SUPERIORITY_OR_OTHER||GMT Ratio|0.5|||||TWO_SIDED|95.0|0.38|0.81||||||Serotype 1: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||0.81|0.38|
72502785|NCT01193335|144536065|SUPERIORITY_OR_OTHER||GMT Ratio|0.9|||||TWO_SIDED|95.0|0.76|1.17||||||Serotype 3: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||1.17|0.76|
72502786|NCT01193335|144536065|SUPERIORITY_OR_OTHER||GMT Ratio|0.6|||||TWO_SIDED|95.0|0.45|0.91||||||Serotype 5: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||0.91|0.45|
72621322|NCT02732145|144773192|SUPERIORITY|Question: Is there a difference in the incidence of erythema of Labia Minora among patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of erythema of Labia Minora in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q- Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of vulvodynia."||||0.0000
72502787|NCT01193335|144536065|SUPERIORITY_OR_OTHER||GMT Ratio|0.6|||||TWO_SIDED|95.0|0.47|0.85||||||Serotype 6A: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||0.85|0.47|
72502788|NCT01193335|144536065|SUPERIORITY_OR_OTHER||GMT Ratio|0.9|||||TWO_SIDED|95.0|0.74|1.15||||||Serotype 7F: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||1.15|0.74|
72502789|NCT01193335|144536065|SUPERIORITY_OR_OTHER||GMT Ratio|0.7|||||TWO_SIDED|95.0|0.52|0.88||||||Serotype 19A: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||0.88|0.52|
72502790|NCT01193335|144536066|SUPERIORITY_OR_OTHER||GMT Ratio|0.8|||||TWO_SIDED|95.0|0.35|2.05||||||Serotype 4: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||2.05|0.35|
72502791|NCT01193335|144536066|SUPERIORITY_OR_OTHER||GMT Ratio|1.0|||||TWO_SIDED|95.0|0.41|2.63||||||Serotype 6B: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||2.63|0.41|
72502792|NCT01193335|144536066|SUPERIORITY_OR_OTHER||GMT Ratio|0.6|||||TWO_SIDED|95.0|0.22|1.53||||||Serotype 9V: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||1.53|0.22|
72465538|NCT00526097|144453950|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.6|STANDARD_ERROR_OF_MEAN|1.94||0.7543||95.0|-3.2|4.4||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate||4.4|-3.2|0.7543
72465539|NCT00526097|144453951|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.5|STANDARD_ERROR_OF_MEAN|1.58||0.0273||95.0|0.4|6.6||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate||6.6|0.4|0.0273
72465540|NCT00526097|144453952|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.3|STANDARD_ERROR_OF_MEAN|0.87||0.129||95.0|-0.4|3.0||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate||3.0|-0.4|0.1290
72465541|NCT00526097|144453953|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.6|STANDARD_ERROR_OF_MEAN|0.7||0.378||95.0|-0.8|2.0||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate||2.0|-0.8|0.3780
72465542|NCT00526097|144453954|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|0.08|<|0.0001||95.0|-0.6|-0.3||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate||-0.3|-0.6|<0.0001
72465543|NCT00526097|144453955|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001||95.0|-1.0|-0.7||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate||-0.7|-1.0|<0.0001
72465544|NCT00526097|144453956|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.07||0.007||95.0|-0.3|-0.1||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate||-0.1|-0.3|0.0070
72465545|NCT00526097|144453957|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.2|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001||95.0|-1.5|-1.0||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate||-1.0|-1.5|<0.0001
72465546|NCT00526097|144453958|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|0.08|<|0.0001||95.0|-0.8|-0.5||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate||-0.5|-0.8|<0.0001
72564151|NCT02418455|144659926|SUPERIORITY||LS Mean|-0.56|STANDARD_ERROR_OF_MEAN|0.503||0.2618|TWO_SIDED|95.0|-1.55|0.42||From generalized estimating equation model including baseline value and visit as a categorical variable. Change from baseline in Liver Ultrasound (cm) as a dependent variable. Covariance structure within subjects is assumed to be exchangeable.|generalized estimating equation|||Change at Week 144||0.42|-1.55|0.2618
72564152|NCT01557920|144659961|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED|||||pathological swallows under anesthesia vs. wakefulness: 25.9% vs. 4.9%|Mixed Models Analysis|||||||0.001
72564153|NCT01557920|144659961|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Mixed Models Analysis|||Comparison of pathological swallow-rate increase by carbon-dioxide during anesthesia and wakefulness||||<0.001
72564154|NCT01557920|144659966|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||The number of swallows per hour: 1.7±3.3 during anesthesia vs. 28.0±22.3 during wakefulness|Mixed Models Analysis|||||||<0.001
72564155|NCT04458467|144660014|SUPERIORITY|||||||0.033|||||||t-test, 2 sided|||||||0.033
72564156|NCT04458467|144660015|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
72465547|NCT00460564|144453962|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-6.83|||<|0.001||95.0|-10.567|-3.093|||t-test, 2 sided|||||-3.093|-10.567|<0.001
72465548|NCT02412111|144454004|SUPERIORITY||Least Square (LS) mean difference|0.3|||=|0.5846|TWO_SIDED|95.0|-0.8|1.4|||Mixed Model for Repeated Measures (MMRM)|||||1.4|-0.8|= 0.5846
72465549|NCT02412111|144454005|SUPERIORITY||Least square mean difference|0.8|||=|0.386|TWO_SIDED|95.0|-1.0|2.6|||Mixed models Repeated Measures (MMRM)|||||2.6|-1.0|= 0.3860
72465550|NCT02412111|144454006|SUPERIORITY||Least square mean difference|2.8|||=|0.1236|TWO_SIDED|95.0|-0.8|6.4|||Mixed models Repeated Measures (MMRM)|||||6.4|-0.8|= 0.1236
72465551|NCT02412111|144454007|SUPERIORITY||Least square mean difference|-5.8|||=|0.0216|TWO_SIDED|95.0|-10.7|-0.9|||Mixed models Repeated Measures (MMRM)|||||-0.9|-10.7|= 0.0216
72564157|NCT01040793|144660089|SUPERIORITY_OR_OTHER||Ratio to placebo|1.118|STANDARD_ERROR_OF_MEAN|0.04||0.0018||95.0|1.043|1.199|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline endurance time and period as fixed and patient as random effect. Means, CI back-transformed.|Olo 5 mcg divided by Placebo|||1.199|1.043|0.0018
72564158|NCT01040793|144660089|SUPERIORITY_OR_OTHER||Ratio to placebo|1.105|STANDARD_ERROR_OF_MEAN|0.039||0.0052||95.0|1.03|1.184|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline endurance time and period as fixed and patient as random effect. Means, CI back-transformed.|Olo 10 mcg divided by Placebo|||1.184|1.030|0.0052
72465552|NCT04349644|144454012|OTHER|A series of Analysis of Covariance (ANCOVA) models were used to test the between-group differences on each dependent variable at the immediate posttest and at the follow-up periods separately using the pretest values as a covariate. Independent samples t-tests were used to identify statistically significant differences on all pretest dependent vari- ables.||||||0.016|||||||ANCOVA|Posttest ANCOVA controlling for pretest values.||||||0.016
72465553|NCT04349644|144454012|OTHER|"A series of Analysis of Covariance (ANCOVA) models were used to test the between-group differences on each depen- dent variable at the immediate posttest and at the follow-up periods separately using the pretest values as a covariate.~Independent samples t-tests were used to identify statistically significant differences on all pretest dependent variables."||||||0.288|||||||ANCOVA|Follow-up ANCOVA while controlling Pretest.||||||0.288
72465554|NCT04349644|144454013|OTHER|A series of Analysis of Covariance (ANCOVA) models were used to test the between-group differences on each dependent variable at the immediate posttest and at the follow-up periods separately using the pretest values as a covariate. Independent samples t-tests were used to identify statistically significant differences on all pretest dependent variables.||||||0.932|||||||ANCOVA|Posttest ANCOVA controlling pretest value for CASS Vocal Expressiveness.||||||0.932
72465555|NCT04349644|144454013|OTHER|A series of Analysis of Covariance (ANCOVA) models were used to test the between-group differences on each dependent variable at the immediate posttest and at the follow-up periods separately using the pretest values as a covariate. Independent samples t-tests were used to identify statistically significant differences on all pretest dependent variables.||||||0.221|||||||ANCOVA|Posttest ANCOVA controlling for pretest for CASS Quality of Rapport.||||||0.221
72465556|NCT04349644|144454013|OTHER|A series of Analysis of Covariance (ANCOVA) models were used to test the between-group differences on each dependent variable at the immediate posttest and at the follow-up periods separately using the pretest values as a covariate. Independent samples t-tests were used to identify statistically significant differences on all pretest dependent variables.||||||0.873|||||||ANCOVA|Follow-up ANCOVA controlling for pretest Vocal Expressiveness.||||||0.873
72465557|NCT04349644|144454013|OTHER|A series of Analysis of Covariance (ANCOVA) models were used to test the between-group differences on each dependent variable at the immediate posttest and at the follow-up periods separately using the pretest values as a covariate. Independent samples t-tests were used to identify statistically significant differences on all pretest dependent variables.||||||0.512|||||||ANCOVA|Follow-up ANCOVA controlling for pretest Quality of Rapport.||||||0.512
72564159|NCT01040793|144660090|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.084|STANDARD_ERROR_OF_MEAN|0.035||0.0155||95.0|0.016|0.152|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 5 mcg minus Placebo|||0.152|0.016|0.0155
72564160|NCT01040793|144660090|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.166|STANDARD_ERROR_OF_MEAN|0.034|<|0.0001||95.0|0.098|0.234|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 10 mcg minus Placebo|||0.234|0.098|<0.0001
72564161|NCT01040793|144660091|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.366|STANDARD_ERROR_OF_MEAN|0.214||0.1176||95.0|-0.757|0.085|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 5 mcg minus Placebo|||0.085|-0.757|0.1176
72465558|NCT04349644|144454014|OTHER|A series of Analysis of Covariance (ANCOVA) models were used to test the between-group differences on each dependent variable at the immediate posttest and at the follow-up periods separately using the pretest values as a covariate. Independent samples t-tests were used to identify statistically significant differences on all pretest dependent variables.||||||0.05|||||||ANCOVA|Posttest ANCOVA controlling for Pretest.||||||0.05
72465559|NCT04349644|144454014|OTHER|A series of Analysis of Covariance (ANCOVA) models were used to test the between-group differences on each dependent variable at the immediate posttest and at the follow-up periods separately using the pretest values as a covariate. Independent samples t-tests were used to identify statistically significant differences on all pretest dependent variables.||||||0.393|||||||ANCOVA|Follow-up ANCOVA controlling for Pretest.||||||0.393
72465560|NCT04349644|144454015|OTHER|A series of Analysis of Covariance (ANCOVA) models were used to test the between-group differences on each dependent variable at the immediate posttest and at the follow-up periods separately using the pretest values as a covariate. Independent samples t-tests were used to identify statistically significant differences on all pretest dependent variables||||||0.917|||||||ANCOVA|Posttest ANCOVA controlling for pretest values.||||||0.917
72465561|NCT04349644|144454015|OTHER|A series of Analysis of Covariance (ANCOVA) models were used to test the between-group differences on each dependent variable at the immediate posttest and at the follow-up periods separately using the pretest values as a covariate. Independent samples t-tests were used to identify statistically significant differences on all pretest dependent variables||||||0.963|||||||ANCOVA|Follow-up ANCOVA while controlling for pretest.||||||0.963
72465562|NCT01114139|144454027|SUPERIORITY|The 95% confidence interval was calculated using the large sample assumption.|Treatment Difference|75.59|||<|0.0001|TWO_SIDED|95.0|71.15|80.02|||Cochran-Mantel-Haenszel|The p-value is the result of the Cochran-Mantel-Haenszel test, adjusted for Baseline hemoglobin level and underlying condition.|The treatment difference (ferumoxytol - placebo) was expressed as a percentage.|Participants who achieved a ≥2.0 g/dL increase in hemoglobin from Baseline up to Week 5 were analyzed. Statistical comparison was performed for data up to Week 5 only. Baseline was defined as the Day 1 value (prior to injection of study drug). The screening or most recent value prior to Day 1 was used for any participant with missing Day 1 information.||80.02|71.15|<0.0001
72465563|NCT03677245|144454063|OTHER|Wilcoxon signed ranks test used to compared pre-intervention to post-intervention means of the Pediatric Balance Scale. No power calculation performed or utilized.|Mean Difference (Final Values)|1.0|||<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<0.05
72564162|NCT01040793|144660091|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.066|STANDARD_ERROR_OF_MEAN|0.214||0.7591||95.0|-0.486|0.355|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 10 mcg minus Placebo|||0.355|-0.486|0.7591
72465564|NCT01049984|144454088|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.4||||0.012|TWO_SIDED|95.0|-4.3|-0.5||All analyses were performed at the 2-sided 0.05 significance level. P values were not adjusted.|ANCOVA|Repeated measures model with baseline score as a covariate and factors Treatment, Week in Study, Pooled Center and Week by Treatment interaction.||||-0.5|-4.3|0.012
72465565|NCT01049984|144454089|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4||||0.301|TWO_SIDED|95.0|-1.1|0.3||All analyses were performed at the 2-sided 0.05 significance level. P values were not adjusted.|ANCOVA|Repeated measures model with baseline score as a covariate and factors Treatment, Week in Study, Pooled Center and Week by Treatment interaction.||||0.3|-1.1|0.301
72465566|NCT01049984|144454090|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.8||||0.007|TWO_SIDED|95.0|-3.1|-0.5||All analyses were performed at the 2-sided 0.05 significance level. P values were not adjusted.|ANCOVA|Repeated measures model with baseline score as a covariate and factors Treatment, Week in Study, Pooled Center and Week by Treatment interaction.||||-0.5|-3.1|0.007
72465567|NCT01049984|144454091|SUPERIORITY_OR_OTHER|||||||0.255||||||All analyses were performed at the 2-sided 0.05 significance level. P values were not adjusted. Only participants with assessment (\>0) are included in the CMH test.|Cochran-Mantel-Haenszel|CMH used the proportion of participants in each category between the two treatment arms, with treatment and pooled center as strata.||||||0.255
72465568|NCT01049984|144454092|SUPERIORITY_OR_OTHER|||||||0.996||||||All analyses were performed at the 2-sided 0.05 significance level. P values were not adjusted. Only participants with assessment (\>0) are included in the CMH test.|Cochran-Mantel-Haenszel|CMH used the proportion of participants in each category between the two treatment arms, with treatment and pooled center as strata.||||||0.996
72465569|NCT01049984|144454093|SUPERIORITY_OR_OTHER|||||||0.967||||||All analyses were performed at the 2-sided 0.05 significance level. P values were not adjusted. Only participants with assessment (\>0) are included in the CMH test.|Cochran-Mantel-Haenszel|CMH used the proportion of participants in each category between the two treatment arms, with treatment, pooled center, and baseline value as strata.||||||0.967
72465570|NCT02287883|144454109|OTHER|Clustered two-sample t-test||||||0.8|||||||t-test, 2 sided|||||||0.80
72465571|NCT02287883|144454110|OTHER|Clustered two-sample t-test||||||0.48|||||||t-test, 2 sided|||||||0.48
72465572|NCT02287883|144454111|OTHER|Clustered two-sample t-test||||||0.05|||||||t-test, 2 sided|||||||0.05
72465573|NCT00802438|144454112|OTHER||||||<|0.0001||||||A two-sided p-value\<0.05 was considered significant. Analyses were conducted using SAS version 9.4 (SAS Institute, Cary, NC.).|t-test, 2 sided|||Summaries of log-transformed data were back-transformed to the original scale and reported as geometric mean with 95% confidence interval or median within 1st and 3rd quartiles. Outcomes are summarized using least squares means with 95% confidence intervals or median with 1st and 3rd quartiles.||||<0.0001
72465574|NCT00802438|144454113|OTHER|Summaries of log-transformed data were back-transformed to the original scale and reported as geometric mean with 95% confidence interval or median within 1st and 3rd quartiles. Outcomes are summarized using least squares means with 95% confidence intervals or median with 1st and 3rd quartiles.||||||0.01|||||||t-test, 2 sided|||||||0.01
72465575|NCT02341599|144454170|OTHER|LS mean ratio of Group B/Group A|LS mean ratio|1.29|||||TWO_SIDED|90.0|1.06|1.58|||||LS mean ratio was calculated from analysis of variance (ANOVA) model.|||1.58|1.06|
72465576|NCT02341599|144454170|OTHER|LS mean ratio of Group C/Group A|LS mean ratio|1.08|||||TWO_SIDED|90.0|0.889|1.32|||||LS mean ratio was calculated from ANOVA model.|||1.32|0.889|
72465577|NCT02341599|144454170|OTHER|LS mean ratio of Group D/Group A|LS mean ratio|2.51|||||TWO_SIDED|90.0|2.06|3.06|||||LS mean ratio was calculated from ANOVA model.|||3.06|2.06|
72465578|NCT02341599|144454170|OTHER|LS mean ratio of Group E: Period 1/Group A|LS mean ratio|0.989|||||TWO_SIDED|90.0|0.806|1.21|||||LS mean ratio was calculated from ANOVA model.|||1.21|0.806|
72465579|NCT02341599|144454170|OTHER|LS mean ratio of Group E: Period 2/Group A|LS mean ratio|3.27|||||TWO_SIDED|90.0|2.67|4.02|||||LS mean ratio was calculated from ANOVA model.|||4.02|2.67|
72564163|NCT01040793|144660092|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.164|STANDARD_ERROR_OF_MEAN|0.036|<|0.0001||95.0|0.094|0.234|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 5 mcg minus Placebo|||0.234|0.094|<0.0001
72465580|NCT02341599|144454170|OTHER|LS mean ratio of Group E: Period 1/Group E: Period 2|LS mean ratio|0.299|||||TWO_SIDED|90.0|0.236|0.378|||||LS mean ratio was calculated from ANOVA model.|||0.378|0.236|
72465581|NCT02341599|144454171|OTHER|LS mean ratio of Group B/Group A|LS mean ratio|1.04|||||TWO_SIDED|90.0|0.846|1.27|||||LS mean ratio was calculated from ANOVA model.|||1.27|0.846|
72465582|NCT02341599|144454171|OTHER|LS mean ratio of Group C/Group A|LS mean ratio|0.524|||||TWO_SIDED|90.0|0.428|0.641|||||LS mean ratio was calculated from ANOVA model.|||0.641|0.428|
72465583|NCT02341599|144454171|OTHER|LS mean ratio of Group D/Group A|LS mean ratio|0.678|||||TWO_SIDED|90.0|0.554|0.831|||||LS mean ratio was calculated from ANOVA model.|||0.831|0.554|
72465584|NCT02341599|144454171|OTHER|LS mean ratio of Group E: Period 1/Group A|LS mean ratio|0.273|||||TWO_SIDED|90.0|0.221|0.336|||||LS mean ratio was calculated from ANOVA model.|||0.336|0.221|
72465585|NCT02341599|144454171|OTHER|LS mean ratio of Group E: Period 2/Group A|LS mean ratio|0.326|||||TWO_SIDED|90.0|0.265|0.402|||||LS mean ratio was calculated from ANOVA model.|||0.402|0.265|
72465586|NCT02341599|144454171|OTHER|LS mean ratio of Group E: Period 2/Group E: Period 1|LS mean ratio|0.808|||||TWO_SIDED|90.0|0.65|1.0|||||LS mean ratio was calculated from ANOVA model.|||1.00|0.650|
72502793|NCT01193335|144536066|SUPERIORITY_OR_OTHER||GMT Ratio|0.7|||||TWO_SIDED|95.0|0.38|1.44||||||Serotype 14: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||1.44|0.38|
72502794|NCT01193335|144536066|SUPERIORITY_OR_OTHER||GMT Ratio|0.3|||||TWO_SIDED|95.0|0.1|0.76||||||Serotype 18C: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||0.76|0.10|
72502795|NCT01193335|144536066|SUPERIORITY_OR_OTHER||GMT Ratio|0.6|||||TWO_SIDED|95.0|0.25|1.3||||||Serotype 19F: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||1.30|0.25|
72465587|NCT00988117|144454208|SUPERIORITY_OR_OTHER||Tscore|5.19|||<|0.01||95.0||||t-tests were statistically thresholded using the joint probability distribution method to correct for multiple comparisons, p \< 0.01 for voxel height and p \< 0.05 for cluster extent|t-test, 2 sided|A mask included only those regions where the patients showed abnormally low fALFF at either timepoint relative to a sample of 15 age-matched controls.||"Each voxel's BOLD signal time series was detrended and transformed to the frequency domain. We divided the sum of the square roots across the 0.01-0.08 Hz range by that across the entire frequency range (0-0.25 Hz).~fALFF group comparisons were evaluated using t-tests corrected for multiple comparisons. To determine if there were treatment-associated changes in brain activity, we compared voxel-wise fALFF in the patients at baseline to post-treatment."||||<0.01
72465588|NCT00988117|144454209|SUPERIORITY_OR_OTHER||pearson's r correlation coefficient|-0.82|||<|0.01||95.0||||This p-value was not adjusted for multiple comparisons.|Regression, Linear|||correlation with left inferior frontal gyrus / premotor falff change||||<.01
72465589|NCT00988117|144454209|SUPERIORITY_OR_OTHER||pearson's correlation coefficient|-0.35||||0.36||95.0||||This p-value was not adjusted for multiple comparisons.|Regression, Linear|||correlation with left supplementary motor area falff change||||.36
72465590|NCT00988117|144454210|SUPERIORITY_OR_OTHER||pearson's r correlation|0.18||||0.58||95.0|||||Regression, Linear|||correlation with left premotor / inferior frontal gyri falff change||||.58
72465591|NCT00988117|144454210|SUPERIORITY_OR_OTHER||pearson's correlation coefficient|0.26||||0.41||95.0||||This p-value was not adjusted for multiple comparisons.|Regression, Linear|||correlation with left supplementary motor area falff change||||.41
72465592|NCT00312845|144454211|SUPERIORITY_OR_OTHER|||||||0.039||95.0|||||Log Rank|||||||0.039
72465593|NCT00312845|144454212|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel|||||||<0.001
72465594|NCT01355471|144454242|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||GEE: Logit link function|Generalized Estimation Equation (GEE) methods with Logit link function and marginal expectation model.||||||<0.001
72465595|NCT00496834|144454294|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|non-inferiority margin= -1.5m/s|Mean Difference (Final Values)|-0.41|STANDARD_DEVIATION|1.43|||TWO_SIDED|95.0|-0.83|0.01|||||The lower limit of ≥-1.5m/s was judged to prove the non-inferiority of the test group to the control group.|Participants for analysis was modified intention to treat (Number of patients: Losartan group was 88, Carvedilol group was 94).||0.01|-0.83|
72465596|NCT00496834|144454295|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|non-inferiority margin=-1.5m/s|Mean Difference (Final Values)|-0.36|STANDARD_DEVIATION|1.4|||TWO_SIDED|95.0|-0.86|0.15|||||The lower limit of ≥-1.5m/s was judged to prove the non-inferiority of the test group to the control group.|Participants for analysis was per protocol (Number of patients: Losartan group was 54, Carvedilol group was 67). For the primary efficacy endpoints, Per protocol analysis approach was supplementary used.||0.15|-0.86|
72564164|NCT01040793|144660092|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.195|STANDARD_ERROR_OF_MEAN|0.036|<|0.0001||95.0|0.125|0.265|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 10 mcg minus Placebo|||0.265|0.125|<0.0001
72564165|NCT01040793|144660093|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.078|STANDARD_ERROR_OF_MEAN|0.034||0.0245||95.0|0.01|0.146|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 5 mcg minus Placebo|||0.146|0.010|0.0245
72465597|NCT00496834|144454296|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9032||95.0||||Significance level=0.05|t-test, 2 sided|The secondary efficacy analysis was performed in the modified intention to treat population using t-test.||||||0.9032
72465598|NCT00496834|144454297|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6574||95.0||||Significance level=0.05|t-test, 2 sided|The secondary efficacy analysis was performed in the modified intention to treat population using t-test||||||0.6574
72465599|NCT01227928|144454298|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.984|||||TWO_SIDED|95.0|0.595|1.626|||||The Hazard Ratio (HR) is estimated using a Pike estimator. The HR was adjusted for the stratification factor of first-line treatment outcome.|||1.626|0.595|
72564166|NCT01040793|144660093|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.172|STANDARD_ERROR_OF_MEAN|0.034|<|0.0001||95.0|0.105|0.24|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 10 mcg minus Placebo|||0.240|0.105|<0.0001
72564167|NCT01040793|144660094|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.074|STANDARD_ERROR_OF_MEAN|0.07||0.2897||95.0|-0.211|0.063|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 5 mcg minus Placebo|||0.063|-0.211|0.2897
72465600|NCT01227928|144454299|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.811||||0.5901|TWO_SIDED|95.0|0.376|1.751|||Log Rank||The Hazard Ratio (HR) is estimated using a Pike estimator. The HR was adjusted for the three stratification factors.|||1.751|0.376|0.5901
72465601|NCT01042145|144454313|SUPERIORITY_OR_OTHER|||||||0.34|||||||Fisher Exact|||||||0.34
72465602|NCT01042145|144454314|SUPERIORITY_OR_OTHER|||||||0.63||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.63
72465603|NCT01042145|144454316|SUPERIORITY_OR_OTHER|||||||0.51||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.51
72465604|NCT01042145|144454317|SUPERIORITY_OR_OTHER|||||||0.24||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.24
72465605|NCT01042145|144454318|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|||||||1.0
72465606|NCT01494298|144454319|SUPERIORITY_OR_OTHER||||||=|0.002||95.0||||The control group average age was 6 years lower(P=0.001). Results were adjusted via a logistic regression and presented as age-adjusted means and SE. The unadjusted differences had similar results.|t-test, 2 sided|||Hypothesis - There will be differences in ApoB between AA with T2DM and those without. To achieve a power of 80%, 48 subjects in each group were needed to detect 15 mg/dL difference in ApoB levels, assuming a standard deviation of 26 mg/dL if alpha was set at 0.05. Continuous data were compared using a Students t-test and categorical data were compared using test.||||=0.002
72465607|NCT01494298|144454321|SUPERIORITY_OR_OTHER|||||||0.84||95.0|||||t-test, 2 sided|||||||0.84
72465608|NCT04159805|144454323|SUPERIORITY||Difference in Least Square (LS) Mean|0.29|||=|0.772|TWO_SIDED|95.0|-1.72|2.3||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 4||2.30|-1.72|=0.772
72465609|NCT04159805|144454323|SUPERIORITY||Difference in LS Mean|1.01|||=|0.299|TWO_SIDED|95.0|-0.94|2.97||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 4||2.97|-0.94|=0.299
72465610|NCT04159805|144454323|SUPERIORITY||Difference in LS Mean|-0.11|||=|0.924|TWO_SIDED|95.0|-2.34|2.13||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 6||2.13|-2.34|=0.924
72465611|NCT04159805|144454323|SUPERIORITY||Difference in LS Mean|1.86|||=|0.091|TWO_SIDED|95.0|-0.32|4.04||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 6||4.04|-0.32|=0.091
72465612|NCT04159805|144454323|SUPERIORITY||Difference in LS Mean|-0.18|||=|0.887|TWO_SIDED|95.0|-2.82|2.45||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 8||2.45|-2.82|=0.887
72502796|NCT01193335|144536066|SUPERIORITY_OR_OTHER||GMT Ratio|0.3|||||TWO_SIDED|95.0|0.11|0.65||||||Serotype 23F: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||0.65|0.11|
72502797|NCT01193335|144536066|SUPERIORITY_OR_OTHER||GMT Ratio|1.0|||||TWO_SIDED|95.0|0.81|1.32||||||Serotype 1: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||1.32|0.81|
72502798|NCT01193335|144536066|SUPERIORITY_OR_OTHER||GMT Ratio|0.9|||||TWO_SIDED|95.0|0.56|1.37||||||Serotype 3: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||1.37|0.56|
72502799|NCT01193335|144536066|SUPERIORITY_OR_OTHER||GMT Ratio|0.8|||||TWO_SIDED|95.0|0.51|1.23||||||Serotype 5: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||1.23|0.51|
72564168|NCT01040793|144660094|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.025|STANDARD_ERROR_OF_MEAN|0.069||0.7199||95.0|-0.162|0.112|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 10 mcg minus Placebo|||0.112|-0.162|0.7199
72564169|NCT01040793|144660095|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.091|STANDARD_ERROR_OF_MEAN|0.146||0.5313||95.0|-0.196|0.379|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 5 mcg minus Placebo|||0.379|-0.196|0.5313
72564170|NCT01040793|144660095|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.341|STANDARD_ERROR_OF_MEAN|0.146||0.0198||95.0|0.055|0.628|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 10 mcg minus Placebo|||0.628|0.055|0.0198
72564171|NCT01040793|144660096|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.086|STANDARD_ERROR_OF_MEAN|0.053||0.1048||95.0|-0.19|0.018|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 5 mcg minus Placebo|||0.018|-0.190|0.1048
72564172|NCT01040793|144660096|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.12|STANDARD_ERROR_OF_MEAN|0.053||0.0246||95.0|-0.224|-0.015|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 10 mcg minus Placebo|||-0.015|-0.224|0.0246
72465613|NCT04159805|144454323|SUPERIORITY||Difference in LS Mean|1.8|||=|0.162|TWO_SIDED|95.0|-0.76|4.36||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 8||4.36|-0.76|=0.162
72465614|NCT04159805|144454323|SUPERIORITY||Difference in LS Mean|-0.36|||=|0.784|TWO_SIDED|95.0|-3.01|2.29||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 10||2.29|-3.01|=0.784
72502800|NCT01193335|144536066|SUPERIORITY_OR_OTHER||GMT Ratio|0.4|||||TWO_SIDED|95.0|0.17|0.86||||||Serotype 6A: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||0.86|0.17|
72502801|NCT01193335|144536066|SUPERIORITY_OR_OTHER||GMT Ratio|1.1|||||TWO_SIDED|95.0|0.64|1.97||||||Serotype 7F: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||1.97|0.64|
72502802|NCT01193335|144536066|SUPERIORITY_OR_OTHER||GMT Ratio|0.5|||||TWO_SIDED|95.0|0.27|0.97||||||Serotype 19A: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||0.97|0.27|
72502803|NCT01193335|144536067|SUPERIORITY_OR_OTHER||GMT Ratio|0.9|||||TWO_SIDED|95.0|0.33|2.37||||||Serotype 4: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||2.37|0.33|
72564173|NCT01040793|144660097|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.213|STANDARD_ERROR_OF_MEAN|0.053|<|0.0001||95.0|-0.318|-0.108|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 5 mcg minus Placebo|||-0.108|-0.318|<0.0001
72465615|NCT04159805|144454323|SUPERIORITY||Difference in LS Mean|1.79|||=|0.166|TWO_SIDED|95.0|-0.79|4.37||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 10||4.37|-0.79|=0.166
72465616|NCT04159805|144454323|SUPERIORITY||Difference in LS Mean|0.42|||=|0.724|TWO_SIDED|95.0|-1.98|2.82||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 12||2.82|-1.98|=0.724
72465617|NCT04159805|144454323|SUPERIORITY||Difference in LS Mean|1.81|||=|0.124|TWO_SIDED|95.0|-0.52|4.14||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 12||4.14|-0.52|=0.124
72465618|NCT04159805|144454323|SUPERIORITY||Difference in LS Mean|0.29|||=|0.856|TWO_SIDED|95.0|-2.91|3.48||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 14||3.48|-2.91|=0.856
72465619|NCT04159805|144454323|SUPERIORITY||Difference in LS Mean|1.64|||=|0.292|TWO_SIDED|95.0|-1.48|4.76||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 14||4.76|-1.48|=0.292
72465620|NCT04159805|144454323|SUPERIORITY||Difference in LS Mean|0.11|||=|0.944|TWO_SIDED|95.0|-3.14|3.37||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 16||3.37|-3.14|=0.944
72465621|NCT04159805|144454323|SUPERIORITY||Difference in LS Mean|0.85|||=|0.589|TWO_SIDED|95.0|-2.33|4.02||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 16||4.02|-2.33|=0.589
72465622|NCT04159805|144454324|SUPERIORITY||Difference in LS Mean|-0.93|||=|0.406|TWO_SIDED|95.0|-3.17|1.31||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 4||1.31|-3.17|=0.406
72465623|NCT04159805|144454324|SUPERIORITY||Difference in LS Mean|0.9|||=|0.418|TWO_SIDED|95.0|-1.34|3.14||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 4||3.14|-1.34|=0.418
72465624|NCT04159805|144454324|SUPERIORITY||Difference in LS Mean|-0.94|||=|0.463|TWO_SIDED|95.0|-3.53|1.65||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 6||1.65|-3.53|=0.463
72465625|NCT04159805|144454324|SUPERIORITY||Difference in LS Mean|-0.1|||=|0.936|TWO_SIDED|95.0|-2.7|2.49||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 6||2.49|-2.70|=0.936
72465626|NCT04159805|144454324|SUPERIORITY||Difference in LS Mean|-1.8|||=|0.17|TWO_SIDED|95.0|-4.41|0.82||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 8||0.82|-4.41|=0.170
72465627|NCT04159805|144454324|SUPERIORITY||Difference in LS Mean|0.52|||=|0.687|TWO_SIDED|95.0|-2.1|3.13||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 8||3.13|-2.10|=0.687
72465628|NCT04159805|144454324|SUPERIORITY||Difference in LS Mean|-1.24|||=|0.374|TWO_SIDED|95.0|-4.05|1.57||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 10||1.57|-4.05|=0.374
72465629|NCT04159805|144454324|SUPERIORITY||Difference in LS Mean|0.99|||=|0.478|TWO_SIDED|95.0|-1.82|3.8||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 10||3.80|-1.82|=0.478
72465630|NCT04159805|144454324|SUPERIORITY||Difference in LS Mean|-0.51|||=|0.69|TWO_SIDED|95.0|-3.12|2.09||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 12||2.09|-3.12|=0.690
72465631|NCT04159805|144454324|SUPERIORITY||Difference in LS Mean|2.12|||=|0.106|TWO_SIDED|95.0|-0.48|4.71||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 12||4.71|-0.48|=0.106
72465632|NCT04159805|144454324|SUPERIORITY||Difference in LS Mean|-0.89|||=|0.547|TWO_SIDED|95.0|-3.89|2.12||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 14||2.12|-3.89|=0.547
72465633|NCT04159805|144454324|SUPERIORITY||Difference in LS Mean|2.19|||=|0.144|TWO_SIDED|95.0|-0.81|5.18||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 14||5.18|-0.81|=0.144
72465634|NCT04159805|144454324|SUPERIORITY||Difference in LS Mean|-1.37|||=|0.431|TWO_SIDED|95.0|-4.91|2.17||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 16||2.17|-4.91|=0.431
72465635|NCT04159805|144454324|SUPERIORITY||Difference in LS Mean|1.2|||=|0.488|TWO_SIDED|95.0|-2.34|4.74|||MMRM|||Change From Baseline at Week 16||4.74|-2.34|=0.488
72465636|NCT04159805|144454325|SUPERIORITY||Difference in LS Mean|-0.34|||=|0.855|TWO_SIDED|95.0|-4.14|3.45||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 4||3.45|-4.14|=0.855
72465637|NCT04159805|144454325|SUPERIORITY||Difference in LS Mean|3.19|||=|0.093|TWO_SIDED|95.0|-0.56|6.95||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 4||6.95|-0.56|=0.093
72465638|NCT04159805|144454325|SUPERIORITY||Difference in LS Mean|1.8|||=|0.41|TWO_SIDED|95.0|-2.61|6.2||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 6||6.20|-2.61|=0.410
72465639|NCT04159805|144454325|SUPERIORITY||Difference in LS Mean|3.13|||=|0.154|TWO_SIDED|95.0|-1.25|7.5||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 6||7.50|-1.25|=0.154
72465640|NCT04159805|144454325|SUPERIORITY||Difference in LS Mean|-0.94|||=|0.662|TWO_SIDED|95.0|-5.29|3.41||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 8||3.41|-5.29|=0.662
72465641|NCT04159805|144454325|SUPERIORITY||Difference in LS Mean|3.26|||=|0.13|TWO_SIDED|95.0|-1.02|7.54||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 8||7.54|-1.02|=0.130
72465642|NCT04159805|144454325|SUPERIORITY||Difference in LS Mean|1.27|||=|0.586|TWO_SIDED|95.0|-3.44|5.98||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 10||5.98|-3.44|=0.586
72465643|NCT04159805|144454325|SUPERIORITY||Difference in LS Mean|4.93|||=|0.039|TWO_SIDED|95.0|0.26|9.6||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 10||9.60|0.26|=0.039
72465644|NCT04159805|144454325|SUPERIORITY||Difference in LS Mean|-0.22|||=|0.909|TWO_SIDED|95.0|-4.03|3.6||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 12||3.60|-4.03|=0.909
72465645|NCT04159805|144454325|SUPERIORITY||Difference in LS Mean|2.65|||=|0.158|TWO_SIDED|95.0|-1.09|6.4||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 12||6.40|-1.09|=0.158
72564174|NCT01040793|144660097|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.187|STANDARD_ERROR_OF_MEAN|0.054||0.0005||95.0|-0.293|-0.082|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 10 mcg minus Placebo|||-0.082|-0.293|0.0005
72564175|NCT01040793|144660098|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.15|STANDARD_ERROR_OF_MEAN|0.04||0.0002||95.0|0.071|0.228|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 5 mcg minus Placebo|||0.228|0.071|0.0002
72564176|NCT01040793|144660098|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.154|STANDARD_ERROR_OF_MEAN|0.04||0.0001||95.0|0.076|0.233|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 10 mcg minus Placebo|||0.233|0.076|0.0001
72564177|NCT01040793|144660099|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.232|STANDARD_ERROR_OF_MEAN|0.036|<|0.0001||95.0|0.162|0.303|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 5 mcg minus Placebo|||0.303|0.162|<0.0001
72564178|NCT01040793|144660099|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.203|STANDARD_ERROR_OF_MEAN|0.036|<|0.0001||95.0|0.133|0.273|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 10 mcg minus Placebo|||0.273|0.133|<0.0001
72564179|NCT01040793|144660100|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.057|STANDARD_ERROR_OF_MEAN|0.056||0.3109||95.0|-0.053|0.166|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 5 mcg minus Placebo|||0.166|-0.053|0.3109
72564180|NCT01040793|144660100|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.029|STANDARD_ERROR_OF_MEAN|0.056||0.608||95.0|-0.081|0.138|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 10 mcg minus Placebo|||0.138|-0.081|0.6080
72394004|NCT01059825|144294295|SUPERIORITY_OR_OTHER||Difference in least squares means|-32.02||||0|TWO_SIDED|80.0|-39.49|-24.56||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p \<0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-24.56|-39.49|0.000
72394005|NCT01059825|144294295|SUPERIORITY_OR_OTHER||Difference in least squares means|-20.05||||0|TWO_SIDED|80.0|-27.39|-12.72||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p \<0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-12.72|-27.39|0.000
72394006|NCT01059825|144294296|SUPERIORITY_OR_OTHER||Difference in least squares means|-20.96||||0|TWO_SIDED|80.0|-28.58|-13.34||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p \<0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-13.34|-28.58|0.000
72394007|NCT01059825|144294296|SUPERIORITY_OR_OTHER||Difference in least squares means|-21.57||||0|TWO_SIDED|80.0|-29.27|-13.86||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p \<0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-13.86|-29.27|0.000
72394008|NCT01059825|144294296|SUPERIORITY_OR_OTHER||Difference in least squares means|-32.54||||0|TWO_SIDED|80.0|-40.2|-24.88||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p \<0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-24.88|-40.20|0.000
72394009|NCT01059825|144294296|SUPERIORITY_OR_OTHER||Difference in least squares means|-22.33||||0|TWO_SIDED|80.0|-30.05|-14.61||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p \<0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-14.61|-30.05|0.000
72465646|NCT04159805|144454325|SUPERIORITY||Difference in LS Mean|-0.88|||=|0.764|TWO_SIDED|95.0|-6.8|5.05||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 14||5.05|-6.80|=0.764
72465647|NCT04159805|144454325|SUPERIORITY||Difference in LS Mean|5.2|||=|0.08|TWO_SIDED|95.0|-0.67|11.06||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 14||11.06|-0.67|=0.080
72465648|NCT04159805|144454325|SUPERIORITY||Difference in LS Mean|-1.01|||=|0.677|TWO_SIDED|95.0|-5.98|3.95||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 16||3.95|-5.98|=0.677
72394010|NCT01059825|144294296|SUPERIORITY_OR_OTHER||Difference in least squares means|-20.57||||0|TWO_SIDED|80.0|-28.19|-12.96||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p \<0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-12.96|-28.19|0.000
72465649|NCT04159805|144454325|SUPERIORITY||Difference in LS Mean|4.81|||=|0.055|TWO_SIDED|95.0|-0.1|9.73||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 16||9.73|-0.10|=0.055
72564181|NCT01040793|144660101|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.023|STANDARD_ERROR_OF_MEAN|0.056||0.6809||95.0|-0.087|0.133|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 5 mcg minus Placebo|||0.133|-0.087|0.6809
72564182|NCT01040793|144660101|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.056||0.858||95.0|-0.1|0.12|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 10 mcg minus Placebo|||0.120|-0.100|0.8580
72394011|NCT01059825|144294297|SUPERIORITY_OR_OTHER||Difference in least squares means|-22.09||||0|TWO_SIDED|80.0|-29.16|-15.01||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p \<0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-15.01|-29.16|0.000
72394012|NCT01059825|144294297|SUPERIORITY_OR_OTHER||Difference in least squares means|-27.94||||0|TWO_SIDED|80.0|-35.06|-20.83||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p \<0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-20.83|-35.06|0.000
72394013|NCT01059825|144294297|SUPERIORITY_OR_OTHER||Difference in least squares means|-33.12||||0|TWO_SIDED|80.0|-40.29|-25.95||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p \<0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-25.95|-40.29|0.000
72394014|NCT01059825|144294297|SUPERIORITY_OR_OTHER||Difference in least squares means|-31.79||||0|TWO_SIDED|80.0|-39.02|-24.56||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p \<0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-24.56|-39.02|0.000
72394015|NCT01059825|144294297|SUPERIORITY_OR_OTHER||Difference in least squares means|-23.17||||0|TWO_SIDED|80.0|-30.28|-16.07||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p \<0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-16.07|-30.28|0.000
72394016|NCT01059825|144294298|SUPERIORITY_OR_OTHER||Difference in least squares means|-22.07||||0|TWO_SIDED|80.0|-28.87|-15.27||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p \<0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-15.27|-28.87|0.000
72394017|NCT01059825|144294298|SUPERIORITY_OR_OTHER||Difference in least squares means|-28.51||||0|TWO_SIDED|80.0|-35.35|-21.67||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p \<0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-21.67|-35.35|0.000
72564183|NCT01040793|144660102|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.11|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.073|0.148|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 5 mcg minus Placebo|||0.148|0.073|<0.0001
72465650|NCT04159805|144454326|SUPERIORITY||Difference in LS Mean|0.52|||=|0.78|TWO_SIDED|95.0|-3.23|4.27||From a MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 4||4.27|-3.23|=0.780
72465651|NCT04159805|144454326|SUPERIORITY||Difference in LS Mean|0.5|||=|0.771|TWO_SIDED|95.0|-2.99|3.99||From a MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 4||3.99|-2.99|=0.771
72465652|NCT04159805|144454326|SUPERIORITY||Difference in LS Mean|-0.04|||=|0.984|TWO_SIDED|95.0|-4.22|4.14||From a MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 6||4.14|-4.22|=0.984
72465653|NCT04159805|144454326|SUPERIORITY||Difference in LS Mean|2.44|||=|0.213|TWO_SIDED|95.0|-1.47|6.35||From a MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 6||6.35|-1.47|=0.213
72465654|NCT04159805|144454326|SUPERIORITY||Difference in LS Mean|-1.97|||=|0.371|TWO_SIDED|95.0|-6.4|2.45||From a MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 8||2.45|-6.40|=0.371
72465655|NCT04159805|144454326|SUPERIORITY||Difference in LS Mean|0.11|||=|0.956|TWO_SIDED|95.0|-4.01|4.23||From a MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 8||4.23|-4.01|=0.956
72465656|NCT04159805|144454326|SUPERIORITY||Difference in LS Mean|-1.06|||=|0.641|TWO_SIDED|95.0|-5.65|3.53||From a MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 10||3.53|-5.65|=0.641
72465657|NCT04159805|144454326|SUPERIORITY||Difference in LS Mean|-0.33|||=|0.876|TWO_SIDED|95.0|-4.61|3.95||From a MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 10||3.95|-4.61|=0.876
72465658|NCT04159805|144454326|SUPERIORITY||Difference in LS Mean|-1.86|||=|0.458|TWO_SIDED|95.0|-6.91|3.18||From a MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 12||3.18|-6.91|=0.458
72465659|NCT04159805|144454326|SUPERIORITY||Difference in LS Mean|-0.68|||=|0.769|TWO_SIDED|95.0|-5.37|4.0||From a MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 12||4.00|-5.37|=0.769
72465660|NCT04159805|144454326|SUPERIORITY||Difference in LS Mean|-1.14|||=|0.699|TWO_SIDED|95.0|-7.07|4.8||From a MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 14||4.80|-7.07|=0.699
72465661|NCT04159805|144454326|SUPERIORITY||Difference in LS Mean|1.1|||=|0.687|TWO_SIDED|95.0|-4.41|6.62||From a MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 14||6.62|-4.41|=0.687
72465662|NCT04159805|144454326|SUPERIORITY||Difference in LS Mean|0.2|||=|0.944|TWO_SIDED|95.0|-5.55|5.95||From a MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 16||5.95|-5.55|=0.944
72465663|NCT04159805|144454326|SUPERIORITY||Difference in LS Mean|2.48|||=|0.351|TWO_SIDED|95.0|-2.87|7.83||From a MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 16||7.83|-2.87|=0.351
72465664|NCT04159805|144454327|SUPERIORITY||Difference in LS Mean|-27.9|||=|0.09|TWO_SIDED|95.0|-60.18|4.38||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 2||4.38|-60.18|=0.090
72564184|NCT01040793|144660102|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.11|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.073|0.148|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 10 mcg minus Placebo|||0.148|0.073|<0.0001
72564185|NCT01040793|144660103|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.192|STANDARD_ERROR_OF_MEAN|0.021|<|0.0001||95.0|0.151|0.233|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 5 mcg minus Placebo|||0.233|0.151|<0.0001
72564186|NCT01040793|144660103|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.195|STANDARD_ERROR_OF_MEAN|0.021|<|0.0001||95.0|0.153|0.236|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 10 mcg minus Placebo|||0.236|0.153|<0.0001
72465665|NCT04159805|144454327|SUPERIORITY||Difference in LS Mean|-15.77|||=|0.328|TWO_SIDED|95.0|-47.5|15.96||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 2||15.96|-47.50|=0.328
72465666|NCT04159805|144454327|SUPERIORITY||Difference in LS Mean|-12.65|||=|0.441|TWO_SIDED|95.0|-44.94|19.63||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 3||19.63|-44.94|=0.441
72502804|NCT01193335|144536067|SUPERIORITY_OR_OTHER||GMT Ratio|1.1|||||TWO_SIDED|95.0|0.37|3.07||||||Serotype 6B: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||3.07|0.37|
72502805|NCT01193335|144536067|SUPERIORITY_OR_OTHER||GMT Ratio|1.7|||||TWO_SIDED|95.0|0.57|5.36||||||Serotype 9V: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||5.36|0.57|
72502806|NCT01193335|144536067|SUPERIORITY_OR_OTHER||GMT Ratio|0.9|||||TWO_SIDED|95.0|0.38|2.07||||||Serotype 14: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||2.07|0.38|
72502807|NCT01193335|144536067|SUPERIORITY_OR_OTHER||GMT Ratio|0.5|||||TWO_SIDED|95.0|0.18|1.21||||||Serotype 18C: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||1.21|0.18|
72502808|NCT01193335|144536067|SUPERIORITY_OR_OTHER||GMT Ratio|0.6|||||TWO_SIDED|95.0|0.27|1.53||||||Serotype 19F: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||1.53|0.27|
72502809|NCT01193335|144536067|SUPERIORITY_OR_OTHER||GMT Ratio|0.4|||||TWO_SIDED|95.0|0.17|1.15||||||Serotype 23F: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||1.15|0.17|
72502810|NCT01193335|144536067|SUPERIORITY_OR_OTHER||GMT Ratio|1.1|||||TWO_SIDED|95.0|0.96|1.31||||||Serotype 1: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||1.31|0.96|
72502811|NCT01193335|144536067|SUPERIORITY_OR_OTHER||GMT Ratio|0.7|||||TWO_SIDED|95.0|0.41|1.14||||||Serotype 3: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||1.14|0.41|
72564187|NCT01040793|144660104|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.119|STANDARD_ERROR_OF_MEAN|0.036||0.0013||95.0|0.047|0.191|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 5 mcg minus Placebo|||0.191|0.047|0.0013
72502812|NCT01193335|144536067|SUPERIORITY_OR_OTHER||GMT Ratio|0.7|||||TWO_SIDED|95.0|0.49|0.92||||||Serotype 5: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||0.92|0.49|
72502813|NCT01193335|144536067|SUPERIORITY_OR_OTHER||GMT Ratio|0.4|||||TWO_SIDED|95.0|0.16|1.03||||||Serotype 6A: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||1.03|0.16|
72502814|NCT01193335|144536067|SUPERIORITY_OR_OTHER||GMT Ratio|0.6|||||TWO_SIDED|95.0|0.27|1.48||||||Serotype 7F: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||1.48|0.27|
72502815|NCT01193335|144536067|SUPERIORITY_OR_OTHER||GMT Ratio|0.5|||||TWO_SIDED|95.0|0.22|0.91||||||Serotype 19A: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||0.91|0.22|
72502816|NCT01193335|144536068|SUPERIORITY_OR_OTHER||Percent Difference|0.0|||||TWO_SIDED|95.0|-6.33|5.99||||||Serotype 4: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||5.99|-6.33|
72502817|NCT01193335|144536068|SUPERIORITY_OR_OTHER||Percent Difference|-4.89|||||TWO_SIDED|95.0|-16.87|5.39||||||Serotype 6B: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||5.39|-16.87|
72502818|NCT01193335|144536068|SUPERIORITY_OR_OTHER||Percent Difference|-6.85|||||TWO_SIDED|95.0|-24.28|10.67||||||Serotype 9V: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||10.67|-24.28|
72502819|NCT01193335|144536068|SUPERIORITY_OR_OTHER||Percent Difference|3.03|||||TWO_SIDED|95.0|-3.68|10.57||||||Serotype 14: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||10.57|-3.68|
72502820|NCT01193335|144536068|SUPERIORITY_OR_OTHER||Percent Difference|0.0|||||TWO_SIDED|95.0|-6.57|5.88||||||Serotype 18C: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||5.88|-6.57|
72394018|NCT01059825|144294298|SUPERIORITY_OR_OTHER||Difference in least squares means|-35.4||||0|TWO_SIDED|80.0|-42.3|-28.51||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p \<0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-28.51|-42.30|0.000
72394019|NCT01059825|144294298|SUPERIORITY_OR_OTHER||Difference in least squares means|-34.81||||0|TWO_SIDED|80.0|-41.76|-27.86||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p \<0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-27.86|-41.76|0.000
72394020|NCT01059825|144294298|SUPERIORITY_OR_OTHER||Difference in least squares means|-22.75||||0|TWO_SIDED|80.0|-29.58|-15.92||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p \<0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-15.92|-29.58|0.000
72394021|NCT01425281|144294304|SUPERIORITY|||||||0.49|||||||t-test, 2 sided|"Null and alternative hypotheses for superiority testing.~H0: EndpointABSORB BVS = EndpointXIENCE H1: EndpointABSORB BVS ≠ EndpointXIENCE"||Angiographic vasomotion reactivity following nitrate administration, the test was analyzable for 388 paired lesions (Absorb arm \[258 lesions\] vs Xience arm \[130 lesions\]).||||0.49
72394022|NCT01425281|144294305|NON_INFERIORITY|Using t-test with non-inferiority margin of 0.140mm||||||0.78|||||||t-test, 2 sided|"Null and alternative hypotheses for superiority testing.~H0: EndpointABSORB BVS = EndpointXIENCE H1: EndpointABSORB BVS ≠ EndpointXIENCE"||Follow-up angiographic analysis was available for 298 lesions in the Absorb arm and 151 lesions in the Xience arm.||||0.78
72394023|NCT03250845|144294410|SUPERIORITY||||||<|0.0001|||||||t-test, 1 sided|||H0: No difference between Multigam 5% and Multigam 10% infusion time Ha: Multigam 10% infusion time is significantly shorter than Multigam 5%||||<0.0001
72394024|NCT03250845|144294411|SUPERIORITY||||||<|0.0005|||||||t-test, 1 sided|||H0: No difference in hospitalisation time between Multigam 5% and Multigam 10% infusion Ha: Hospitalisation time with Multigam 10% infusion is significantly shorter than with Multigam 5%||||<0.0005
72394025|NCT03250845|144294413|SUPERIORITY|||||||0.03|||||||t-test, 1 sided|||H0: No difference in number of nursing actions per patient between Multigam 5% and Multigam 10% infusion Ha: Number of nursing actions per patient is smaller with Multigam 10% infusion||||0.03
72465667|NCT04159805|144454327|SUPERIORITY||Difference in LS Mean|1.39|||=|0.931|TWO_SIDED|95.0|-30.33|33.12||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 3||33.12|-30.33|=0.931
72465668|NCT04159805|144454327|SUPERIORITY||Difference in LS Mean|-28.18|||=|0.087|TWO_SIDED|95.0|-60.46|4.11||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 4||4.11|-60.46|=0.087
72394026|NCT03167411|144294416|EQUIVALENCE|The ratio of the least squares (LS) geometric means of Cmax when bexagliflozin is dosed in combination with exenatide versus when dosed alone, with 80-125% defined as the lack of interaction boundaries. 90% confidence intervals was constructed.|Point Estimate (%)|125.27|||||TWO_SIDED|90.0|104.45|150.24|||||Estimated ratio (%) of exponentiated mean difference of log-transformed PK parameter from ANOVA (linear mixed-effects model), with treatment, period, and sequence as fixed effects, and subject as a random effect.|||150.24|104.45|
72394027|NCT03167411|144294419|EQUIVALENCE|The ratio of the least squares (LS) geometric means of AUC0-inf when bexagliflozin is dosed in combination with exenatide versus when dosed alone, with 80-125% defined as the lack of interaction boundaries. 90% confidence intervals was constructed.|Point Estimate (%)|137.56|||||TWO_SIDED|90.0|122.28|154.75|||||Estimated ratio (%) of exponentiated mean difference of log-transformed PK parameter from ANOVA (linear mixed-effects model), with treatment, period, and sequence as fixed effects, and subject as a random effect.|||154.75|122.28|
72394028|NCT00357968|144294476|SUPERIORITY_OR_OTHER||Mean Difference (Net)|43.21|||<|0.0001|TWO_SIDED|95.0|38.04|48.38|||ANCOVA|||||48.38|38.04|<0.0001
72394029|NCT00357968|144294477|SUPERIORITY_OR_OTHER||LS Mean difference|14.93|||<|0.0001|TWO_SIDED|95.0|10.6|19.26|||Mixed Models Analysis|||||19.26|10.6|<0.0001
72394030|NCT00357968|144294478|SUPERIORITY_OR_OTHER||Mean Difference (Net)|44.75|||<|0.0001|TWO_SIDED|95.0|38.35|51.15|||ANCOVA|||||51.15|38.35|<0.0001
72394031|NCT00357968|144294483|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Chi-squared|||||||<0.0001
72394032|NCT00357968|144294484|SUPERIORITY_OR_OTHER|||||||0.0629||95.0|||||Fisher Exact|||||||0.0629
72394033|NCT00357968|144294485|SUPERIORITY_OR_OTHER|||||||0.1827||95.0|||||Fisher Exact|||||||0.1827
72394034|NCT00357968|144294486|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-54.3|||<|0.0001|TWO_SIDED|95.0|-61.2|-47.4|||ANCOVA|||||-47.4|-61.2|<0.0001
72394035|NCT00357968|144294487|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-60.5|||<|0.0001|TWO_SIDED|95.0|-67.1|-54.0|||ANCOVA|||||-54.0|-67.1|<0.0001
72394036|NCT00357968|144294488|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-56.2|||<|0.0001|TWO_SIDED|95.0|-63.2|-49.2|||ANCOVA|||||-49.2|-63.2|<0.0001
72394037|NCT00357968|144294489|SUPERIORITY_OR_OTHER||LS Mean difference|-20.1|||<|0.0001|TWO_SIDED|95.0|-25.7|-14.5|||Mixed Models Analysis|||||-14.5|-25.7|<0.0001
72394038|NCT00357968|144294490|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.47||||0.7058|TWO_SIDED|95.0|-2.95|2.0|||ANCOVA|||||2.00|-2.95|0.7058
72394039|NCT00357968|144294491|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.33||||0.4029|TWO_SIDED|95.0|-4.48|1.82|||ANCOVA|||||1.82|-4.48|0.4029
72465669|NCT04159805|144454327|SUPERIORITY||Difference in LS Mean|4.44|||=|0.783|TWO_SIDED|95.0|-27.29|36.16||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 4||36.16|-27.29|=0.783
72621323|NCT02732145|144773192|SUPERIORITY|Question: Is there a difference in the incidence of erythema of the Posterior Commissure among patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of erythema of the Posterior Commissure in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q- Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of vulvodynia."||||0.0000
72621324|NCT02732145|144773192|SUPERIORITY|Question: Is there a difference in the incidence of fissures of Interlabial Sulci among patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of fissures of Interlabial Sulci in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q- Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of vulvodynia."||||0.0000
72621325|NCT02732145|144773192|SUPERIORITY|Question: Is there a difference in the incidence of fissures of the Posterior Commissure among patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of fissures of the Posterior Commissure in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q- Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of vulvodynia."||||0.0000
72621326|NCT02732145|144773192|SUPERIORITY|Question: Is there a difference in the incidence of smoothness of the Anterior Commissure among patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of smoothness of the Anterior Commissure in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of vulvodynia."||||0.0000
72621327|NCT02732145|144773192|SUPERIORITY|Question: Is there a difference in the incidence of smoothness of Interlabial Sulci among patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of smoothness of Interlabial Sulci in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q- Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of vulvodynia."||||0.0000
72621328|NCT02732145|144773192|SUPERIORITY|Question: Is there a difference in the frequency of smoothness of Labia Minora among patients from different groups?||||||0.0024|||||||Chi-squared|||"Parameter: The frequency of smoothness of Labia Minora in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q- Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of vulvodynia."||||0.0024
72370587|NCT00488683|144251633|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.08||||0.69||95.0|||||Non-parametric correlation||Values from Group 2 and 3 were combined for the analysis.|Spearman correlation coefficient between memory B cells one month after primary vaccination and rise from pre-booster levels in serogroup specific IgG concentration one month after booster vaccination for the serogroup W-135||||0.69
72370588|NCT00488683|144251633|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|-0.13||||0.6||95.0|||||Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccination and rise from pre-booster levels in serogroup specific IgG concentration one month after booster vaccination for the serogroup Y||||0.60
72370589|NCT00488683|144251633|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|-0.01||||0.95||95.0|||||Non-parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Spearman correlation coefficient between memory B cells one month after primary vaccination and rise from pre-booster levels in serogroup specific IgG concentration one month after booster vaccination for the serogroup Y||||0.95
72370590|NCT00488683|144251633|SUPERIORITY_OR_OTHER||R-square|0.0015||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and rise from pre-booster levels in serogroup specific IgG concentration one month after booster vaccination for the serogroup A||||
72370591|NCT00488683|144251633|SUPERIORITY_OR_OTHER||R-square|0.0057||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between memory B cells one month after primary vaccination and rise from pre-booster levels in serogroup specific IgG concentration one month after booster vaccination for the serogroup A||||
72370592|NCT00488683|144251633|SUPERIORITY_OR_OTHER||R-square|0.01||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and rise from pre-booster levels in serogroup specific IgG concentration one month after booster vaccination for the serogroup C||||
72370593|NCT00488683|144251633|SUPERIORITY_OR_OTHER||R-square|0.02||||||95.0|||||Regression, Linear||Values from Groups 2 and 3 were combined for this analysis.|Linear regression coefficient between memory B cells one month after primary vaccination and rise from pre-booster levels in serogroup specific IgG concentration one month after booster vaccination for the serogroup C||||
72370594|NCT00488683|144251633|SUPERIORITY_OR_OTHER||R-square|0.0048||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and rise from pre-booster levels in serogroup specific IgG concentration one month after booster vaccination for the serogroup W-135||||
72370595|NCT00488683|144251633|SUPERIORITY_OR_OTHER||R-square|0.0018||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between memory B cells one month after primary vaccination and rise from pre-booster levels in serogroup specific IgG concentration one month after booster vaccination for the serogroup W-135||||
72370596|NCT00488683|144251633|SUPERIORITY_OR_OTHER||R-square|0.01||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and rise from pre-booster levels in serogroup specific IgG concentration one month after booster vaccination for the serogroup Y||||
72394040|NCT00357968|144294492|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.01||||0.7893|TWO_SIDED|95.0|-0.06|0.08|||ANCOVA|||||0.08|-0.06|0.7893
72394041|NCT00357968|144294493|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.04||||0.4528|TWO_SIDED|95.0|-0.25|0.07|||ANCOVA|||||0.07|-0.25|0.4528
72394042|NCT02846779|144294521|SUPERIORITY||Risk Ratio (RR)|0.88|||||TWO_SIDED|95.0|0.75|1.03||||||||1.03|0.75|
72394043|NCT02846779|144294521|SUPERIORITY||Risk Ratio (RR)|0.91|||||TWO_SIDED|95.0|0.77|1.06||||||||1.06|0.77|
72394044|NCT02846779|144294522|SUPERIORITY||Risk Difference (RD)|-0.15|||||TWO_SIDED|95.0|-0.34|0.05||||||||0.05|-0.34|
72394045|NCT02846779|144294522|SUPERIORITY||Risk Difference (RD)|-0.25|||||TWO_SIDED|95.0|-0.43|-0.06||||||||-0.06|-0.43|
72394046|NCT02846779|144294523|SUPERIORITY||Risk Ratio (RR)|1.03|||||TWO_SIDED|95.0|0.95|1.11||||||||1.11|0.95|
72394047|NCT02846779|144294523|SUPERIORITY||Risk Ratio (RR)|0.99|||||TWO_SIDED|95.0|0.92|1.06||||||||1.06|0.92|
72394048|NCT02846779|144294524|SUPERIORITY||Risk Ratio (RR)|1.0|||||TWO_SIDED|95.0|0.97|1.02||||||||1.02|0.97|
72394049|NCT02846779|144294524|SUPERIORITY||Risk Ratio (RR)|0.98|||||TWO_SIDED|95.0|0.96|1.0||||||||1.00|0.96|
72394050|NCT02846779|144294525|SUPERIORITY||Risk Ratio (RR)|1.38|||||TWO_SIDED|95.0|1.24|1.53||||||||1.53|1.24|
72394051|NCT02846779|144294525|SUPERIORITY||Risk Ratio (RR)|0.96|||||TWO_SIDED|95.0|0.85|1.07||||||||1.07|0.85|
72394052|NCT02846779|144294526|SUPERIORITY||Risk Ratio (RR)|1.22|||||TWO_SIDED|95.0|1.06|1.41||||||||1.41|1.06|
72394053|NCT02846779|144294526|SUPERIORITY||Risk Ratio (RR)|1.14|||||TWO_SIDED|95.0|0.99|1.32||||||||1.32|0.99|
72394054|NCT01325584|144294535|SUPERIORITY|||||||0.07|||||||Wilcoxon (Mann-Whitney)|||||||.07
72394055|NCT01325584|144294537|SUPERIORITY|||||||0.53|||||||Wilcoxon (Mann-Whitney)|||||||.53
72394056|NCT01325584|144294538|SUPERIORITY|||||||0.48|||||||Wilcoxon (Mann-Whitney)|||||||.48
72394057|NCT00887978|144294539|SUPERIORITY_OR_OTHER||Hodges-Lehmann (H-L)|10.0||||0.089|TWO_SIDED|95.0|-2.0|22.0|||non-parametric ANCOVA|||Using an allocation ratio of 1:1 between UT-15C SR and placebo, a fixed sample size of approximately 266 subjects would provide at least 90% power at a significance level of 0.05 (two-sided hypothesis) to detect a 30 meter between-treatment difference in the change from Baseline in distance traversed during the 6-Minute Walk, assuming a standard deviation of 75 meters. A total sample size of approximately 300 subjects was determined to account for discontinuations during the enrollment period.||22.0|-2.0|0.089
72394058|NCT00887978|144294540|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|||||||1.00
72394059|NCT00887978|144294541|SUPERIORITY_OR_OTHER||Hodges-Lehmann (H-L) Estimate|0.0||||0.22|TWO_SIDED|95.0|-1.0|0.0|||Wilcoxon rank sum test|||||0.0|-1.0|0.22
72394060|NCT00887978|144294542|SUPERIORITY_OR_OTHER||Hodges-Lehmann (H-L) estimate|0.0||||0.43|TWO_SIDED|95.0|0.0|0.0||Imputation strategies were implemented for the 26 UT-15C subjects and 17 placebo subjects without values reported at Week 16.|Wilcoxon rank sum test|||||0.0|0.0|0.43
72394061|NCT00887978|144294544|SUPERIORITY_OR_OTHER||Hodges-Lehmann (H-L) estimate|0.0||||0.3|TWO_SIDED|95.0|0.0|1.0|||Wilcoxon rank sum test|||||1.0|0.0|0.30
72394062|NCT00887978|144294547|SUPERIORITY_OR_OTHER||Hodges-Lehman Estimate|14.0||||0.058|TWO_SIDED|95.0|0.0|28.0|||ANCOVA|||||28.0|0.0|0.058
72394063|NCT00887978|144294548|SUPERIORITY_OR_OTHER||Hodges-Lehmann Estimate|15.0||||0.054|TWO_SIDED|95.0|-1.0|29.0|||ANCOVA|||||29.0|-1.0|0.054
72394064|NCT00887978|144294550|SUPERIORITY_OR_OTHER||Hodges-Lehman Estimate|4.0||||0.674|TWO_SIDED|95.0|-16.0|24.0|||ANCOVA|||||24.0|-16.0|0.674
72394065|NCT00887978|144294551|SUPERIORITY_OR_OTHER||Hodges-Lehmann Estimate|28.0||||0.059|TWO_SIDED|95.0|1.0|59.0|||ANCOVA|||||59.0|1.0|0.059
72394066|NCT00887978|144294552|SUPERIORITY_OR_OTHER||Hodges-Lehmann Estimate|10.0||||0.22|TWO_SIDED|95.0|-10.0|31.0|||ANCOVA|||||31.0|-10.0|0.22
72394067|NCT00887978|144294553|SUPERIORITY_OR_OTHER||Hodges-Lehmann Estimate|3.0||||0.99|TWO_SIDED|95.0|-23.0|28.0|||ANCOVA|||||28.0|-23.0|0.99
72394068|NCT00887978|144294554|SUPERIORITY_OR_OTHER||Hodges-Lehmann Estimate|-2.0||||0.84||95.0|-25.0|22.0|||ANCOVA|||||22.0|-25.0|0.84
72394069|NCT04216329|144294562|OTHER|||||||0.02|||||||Students t-test|||||||0.02
72394070|NCT04216329|144294562|OTHER|||||||0.07||||||P-value 0.07 represents the difference between baseline depression scores and completion of treatment scores.|Students t-test|||||||0.07
72394071|NCT04216329|144294562|OTHER|||||||0.02|||||||Students t-test|||||||0.02
72394072|NCT04216329|144294562|OTHER|||||||0.07||||||P-value 0.07 represents the difference between baseline depression scores and completion of treatment scores.|Students t-test|||||||0.07
72394073|NCT04216329|144294562|OTHER|||||||0.02|||||||Students t-test|||||||0.02
72502821|NCT01193335|144536068|SUPERIORITY_OR_OTHER||Percent Difference|3.45|||||TWO_SIDED|95.0|-3.32|11.91||||||Serotype 19F: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||11.91|-3.32|
72394074|NCT04216329|144294562|OTHER|||||||0.07||||||P-value 0.07 represents the difference between baseline depression scores and completion of treatment scores.|Students t-test|||||||0.07
72394075|NCT04216329|144294564|OTHER|||||||0.09|||||||Students t-test|||||||0.09
72394076|NCT04216329|144294564|OTHER|||||||0.09|||||||Students t-test|||||||0.09
72394077|NCT04216329|144294564|OTHER|||||||0.09|||||||Students t-test|||||||0.09
72394078|NCT04600921|144294575|SUPERIORITY|The parameters required to calculate sample size were the expected rate of VT/VF episodes/year in the placebo group, the minimal VT/VF rate ratio to be detected in the ertugliflozin group compared with the placebo group, the average follow-up of treatment duration, the negative binomial dispersion parameter, type 1 error probability, and the desired power.|Rate Ratio|0.16|||<|0.001|TWO_SIDED|95.0|0.04|0.61||The yearly rate ratio was adjusted for baseline number of sVT/VF episodes.|Negative binomial regression model|A prespecified sensitivity analysis was done to mitigate the effect of outliers by using the robust estimation approaches for negative binomial model.|Ertugliflozin is the numerator and the placebo is the denominator.|We compared the rate of sVT/VF episodes between experimental arms after 52 weeks.The initial sample calculation was based on the mathematical formula provided by Zhu and Lakkis for comparing event rates of two negative binomial distributiuons. To detect a 30% reduction in VT/VF episode rates in the ertugliflozin group compared to placebo group, with 80% power and an alpha level of 0.05, accounting for 5% drop out in each group, a total sample size of 402 was estimated to be required.||0.61|0.04|<0.001
72394079|NCT04600921|144294576|SUPERIORITY||Rate Ratio|0.34|||||TWO_SIDED|95.0|0.12|0.97||||||The number of incident nsVT episodes were analyzed using a beta binomial model.||0.97|0.12|
72394080|NCT04600921|144294577|SUPERIORITY||Rate Ratio|0.47|||||TWO_SIDED|95.0|0.13|1.81||||||The number of appropriate ICD therapies were analyzed by using beta binomial model.||1.81|0.13|
72465670|NCT04159805|144454327|SUPERIORITY||Difference in LS Mean|-29.08|||=|0.077|TWO_SIDED|95.0|-61.36|3.21||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 5||3.21|-61.36|=0.077
72621329|NCT02732145|144773192|SUPERIORITY|Question: Is there a difference in the incidence of smoothness of the Posterior Commissure among patients from different groups?||||||0.0205|||||||Chi-squared|||"Parameter: The incidence of smoothness of the Posterior Commissure in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q- Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of vulvodynia."||||0.0205
72621330|NCT02732145|144773192|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of the Anterior Commissure versus non-specific lesions of Interlabial Sulci in patients with vulvar dermatosis?||||||0.0158|||||||t-test proportion|||Parameter: The difference in the incidence of non-specific lesions of the Anterior Commissure versus non-specific lesions of Interlabial Sulci in patients with vulvar dermatosis.||||0.0158
72394081|NCT04600921|144294578|SUPERIORITY||Difference in mean change|0.17|||>|0.05|TWO_SIDED|95.0|-0.35|0.69|||Regression, Linear|||The change in NTproBNP levels was analyzed by using a multiple linear regression model.||0.69|-0.35|>0.05
72394082|NCT04600921|144294579|SUPERIORITY||Mean Difference (Final Values)|0.72|||||TWO_SIDED|95.0|-1.69|3.13||||||The change in HbA1c levels from baseline to week 52 was analyzed by multiple linear regression model.||3.13|-1.69|
72394083|NCT04600921|144294580|SUPERIORITY||Rate Ratio|0.6|||||TWO_SIDED|95.0|0.2|1.7||||||||1.7|0.2|
72465671|NCT04159805|144454327|SUPERIORITY||Difference in LS Mean|-15.72|||=|0.33|TWO_SIDED|95.0|-47.45|16.0||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 5||16.00|-47.45|=0.330
72465672|NCT04159805|144454327|SUPERIORITY||Difference in LS Mean|-14.14|||=|0.4|TWO_SIDED|95.0|-47.19|18.91||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 6||18.91|-47.19|=0.400
72465673|NCT04159805|144454327|SUPERIORITY||Difference in LS Mean|0.0|||=|1|TWO_SIDED|95.0|-32.18|32.19||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 6||32.19|-32.18|=1.000
72465674|NCT04159805|144454327|SUPERIORITY||Difference in LS Mean|-26.47|||=|0.117|TWO_SIDED|95.0|-59.64|6.69||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 7||6.69|-59.64|=0.117
72465675|NCT04159805|144454327|SUPERIORITY||Difference in LS Mean|-12.75|||=|0.436|TWO_SIDED|95.0|-44.94|19.44||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 7||19.44|-44.94|=0.436
72621331|NCT02732145|144773192|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of the Anterior Commissure versus non-specific lesions of the Posterior Commissure in patients with vulvar dermatosis?||||||0.0001|||||||t-test proportion|||Parameter: The difference in the incidence of non-specific lesions of the Anterior Commissure versus non-specific lesions of the Posterior Commissure in patients with vulvar dermatosis.||||0.0001
72621332|NCT02732145|144773192|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of Labia Minora versus non-specific lesions of the Posterior Commissure in patients with vulvar dermatosis?||||||0.028|||||||t-test proportion|||Parameter: The difference in the incidence of non-specific lesions of Labia Minora versus non-specific lesions of the Posterior Commissure in patients with vulvar dermatosis.||||0.0280
72621333|NCT02732145|144773192|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of the Anterior Commissure versus non-specific lesions of Interlabial Sulci in patients with vulvodynia?||||||0|||||||t-test proportion|||"Parameter: The difference in the incidence of non-specific lesions of the Anterior Commissure versus non-specific lesions of Interlabial Sulci in patients with vulvodynia.~The diagnosis of vulvodynia was based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection, Q-Tip) following Friedrich's criteria. Vulvoscopic lesions were not relevant to the diagnosis of vulvodynia."||||0.0000
72621334|NCT02732145|144773192|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of the Anterior Commissure versus non-specific lesions of Labia Minora in patients with vulvodynia?||||||0|||||||t-test proportion|||"Parameter: The difference in the incidence of non-specific lesions of the Anterior Commissure versus non-specific lesions of Labia Minora in patients with vulvodynia.~The diagnosis of vulvodynia was based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection, Q-Tip) following Friedrich's criteria. Vulvoscopic lesions were not relevant to the diagnosis of vulvodynia."||||0.0000
72621335|NCT02732145|144773192|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of the Anterior Commissure versus non-specific lesions of the Posterior Commissure in patients with vulvodynia?||||||0|||||||t-test proportion|||"Parameter: The difference in the incidence of non-specific lesions of the Anterior Commissure versus non-specific lesions of the Posterior Commissure in patients with vulvodynia.~The diagnosis of vulvodynia was based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection, Q-Tip) following Friedrich's criteria. Vulvoscopic lesions were not relevant to the diagnosis of vulvodynia."||||0.0000
72394084|NCT03758274|144294609|SUPERIORITY|||||||0.746|||||||Based on simple path model in Mplus.|||||||0.746
72394085|NCT03758274|144294610|SUPERIORITY|||||||0.247|||||||Based on simple path model in Mplus.|||||||0.247
72394086|NCT03758274|144294611|SUPERIORITY|||||||0.689|||||||Chi-squared|||||||0.689
72394087|NCT00842712|144294657|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.718||||0.0845|TWO_SIDED|95.0|0.492|1.048|||Log Rank|||PFS Time: Independent read||1.048|0.492|0.0845
72394088|NCT00842712|144294658|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.909||||0.5912|TWO_SIDED|95.0|0.642|1.286|||Log Rank|||||1.286|0.642|0.5912
72394089|NCT00842712|144294659|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.813||||0.2648|TWO_SIDED|95.0|0.564|1.171|||Log Rank|||||1.171|0.564|0.2648
72465676|NCT04159805|144454327|SUPERIORITY|From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|Difference in LS Mean|-47.91|||=|0.005|TWO_SIDED|95.0|-81.54|-14.29||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 8||-14.29|-81.54|=0.005
72394090|NCT00875212|144294667|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|5.5|STANDARD_DEVIATION|0.25||0.001||95.0|||||ANOVA|repeated measure anova|The median value of each parameter (pH baseline, minimal pH) was obtained and these values were compared between each group|The study was based on the use of dentifrices for daily oral hygiene in a crossover design. The null hyphothesis was no difference between pH values of the groups. The statistical analysis was by repeated measurements ANOVA.||||0.001
72394091|NCT00875212|144294667|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|5.5|STANDARD_DEVIATION|0.1||0.001||95.0|||||ANOVA|repeated-measurements ANOVA||The comparison was based on mean and median values of plaque pH in different moments of cariogenic challenge. The null hypothesis was that no diference between the groups wil be found. The test hypothesis was that the experimental dentifrice of CaGP-F would provide a better control of plaque pH after 14 days of use.||||0.001
72394092|NCT00875212|144294668|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.5|STANDARD_DEVIATION|0.25||0.01||95.0|||||ANOVA|repeated measurements ANOVA|The difference of pH values between groups was above 1.0 unit.|The groups were compared by repeated measurements anova. There was no power calculation, but a pilot study to check the minimal number necessary of subjects in order to find a signifcant difference between interventions.||||0.01
72394093|NCT04180488|144294700|SUPERIORITY|A hierarchical testing procedure was used to control the overall type I error.|LS Mean Difference|-4.23||||0.0005|TWO_SIDED|95.0|-6.63|-1.84||Threshold for significance at 2-sided 0.05 level.|ANCOVA|||Analyzed by fitting an analysis of covariance (ANCOVA) model with the corresponding baseline value, intervention group, presence of angioedema at baseline, and regions as covariates.||-1.84|-6.63|0.0005
72394094|NCT04180488|144294700|SUPERIORITY|A hierarchical testing procedure was used to control the overall type I error.|LS Mean Difference|-2.87||||0.0449|TWO_SIDED|95.0|-5.68|-0.07||Threshold for significance at 2-sided 0.043 level.|ANCOVA|||Analyzed by fitting an ANCOVA model with the corresponding baseline value, intervention group, presence of angioedema at baseline, and regions as covariates.||-0.07|-5.68|0.0449
72394095|NCT04180488|144294700|SUPERIORITY|A hierarchical testing procedure was used to control the overall type I error.|LS Mean Difference|-2.54||||0.0184|TWO_SIDED|95.0|-4.65|-0.43||Threshold for significance at 2-sided 0.05 level.|ANCOVA|||Analyzed by fitting an ANCOVA model with the corresponding baseline value, intervention group, presence of angioedema at baseline, and regions as covariates.||-0.43|-4.65|0.0184
72465677|NCT04159805|144454327|SUPERIORITY||Difference in LS Mean|-20.48|||=|0.215|TWO_SIDED|95.0|-52.92|11.95||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 8||11.95|-52.92|=0.215
72502822|NCT01193335|144536068|SUPERIORITY_OR_OTHER||Percent Difference|1.52|||||TWO_SIDED|95.0|-6.73|9.94||||||Serotype 23F: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||9.94|-6.73|
72394096|NCT04180488|144294701|SUPERIORITY|A hierarchical testing procedure was used to control the overall type I error.|LS Mean Difference|-8.53||||0.0003|TWO_SIDED|95.0|-13.16|-3.9||Threshold for significance at 2-sided 0.05 level.|ANCOVA|||Analyzed by fitting an ANCOVA model with the corresponding baseline value, intervention group, presence of angioedema at baseline, and regions as covariates.||-3.90|-13.16|0.0003
72394097|NCT04180488|144294701|SUPERIORITY|A hierarchical testing procedure was used to control the overall type I error.|LS Mean Difference|-4.65||||0.0226|TWO_SIDED|95.0|-8.65|-0.65||Threshold for significance at 2-sided 0.05 level.|ANCOVA|||Analyzed by fitting an ANCOVA model with the corresponding baseline value, intervention group, presence of angioedema at baseline, and regions as covariates.||-0.65|-8.65|0.0226
72394098|NCT04180488|144294702|SUPERIORITY|A hierarchical testing procedure was used to control the overall type I error.|LS Mean Difference|-4.38||||0.0003|TWO_SIDED|95.0|-6.78|-1.98||Threshold for significance at 2-sided 0.05 level.|ANCOVA|||Analyzed by fitting an ANCOVA model with the corresponding baseline value, intervention group, presence of angioedema at baseline, and regions as covariates.||-1.98|-6.78|0.0003
72394099|NCT04180488|144294702|SUPERIORITY|A hierarchical testing procedure was used to control the overall type I error.|LS Mean Difference|-2.17||||0.0316|TWO_SIDED|95.0|-4.15|-0.19||Threshold for significance at 2-sided 0.05 level.|ANCOVA|||Analyzed by fitting an ANCOVA model with the corresponding baseline value, intervention group, presence of angioedema at baseline, and regions as covariates.||-0.19|-4.15|0.0316
72394100|NCT04180488|144294703|SUPERIORITY|A hierarchical testing procedure was used to control the overall type I error.|Odds Ratio (OR)|3.413||||0.0014|TWO_SIDED|95.0|1.596|7.299||Threshold for significance at 2-sided 0.05 level.|Cochran-Mantel-Haenszel|||Cochran-Mantel-Haenszel (CMH) test was performed on association between responder status and intervention group, adjusted by baseline disease severity (UAS7\<28,\>=28), presence of angioedema at baseline and region.||7.299|1.596|0.0014
72502823|NCT01193335|144536068|SUPERIORITY_OR_OTHER||Perecent Difference|-10.82|||||TWO_SIDED|95.0|-25.51|4.34||||||Serotype 1: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||4.34|-25.51|
72394101|NCT04180488|144294703|SUPERIORITY|A hierarchical testing procedure was used to control the overall type I error.|Odds Ratio (OR)|2.507||||0.0109|TWO_SIDED|95.0|1.231|5.107||Threshold for significance at 2-sided 0.05 level.|Cochran-Mantel-Haenszel|||CMH test was performed on the association between the responder status and intervention group, adjusted by baseline disease severity (UAS7 \<28, \>=28), presence of angioedema at baseline, and region.||5.107|1.231|0.0109
72621336|NCT02732145|144773192|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of Interlabial Sulci versus non-specific lesions of the Posterior Commissure in patients with vulvodynia?||||||0|||||||t-test proportion|||"Parameter: The difference in the incidence of non-specific lesions of Interlabial Sulci versus non-specific lesions of the Posterior Commissure in patients with vulvodynia.~The diagnosis of vulvodynia was based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection, Q-Tip) following Friedrich's criteria. Vulvoscopic lesions were not relevant to the diagnosis of vulvodynia."||||0.0000
72621337|NCT02732145|144773192|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of Labia Minora versus non-specific lesions of the Posterior Commissure in patients with vulvodynia?||||||0|||||||t-test proportion|||"Parameter: The difference in the incidence of non-specific lesions of Labia Minora versus non-specific lesions of the Posterior Commissure in patients with vulvodynia.~The diagnosis of vulvodynia was based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection, Q-Tip) following Friedrich's criteria. Vulvoscopic lesions were not relevant to the diagnosis of vulvodynia."||||0.0000
72621338|NCT02732145|144773192|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of the Anterior Commissure versus non-specific lesions of Interlabial Sulci in patients with impaired vulvar skin?||||||0|||||||t-test proportion|||Parameter: The difference in the incidence of non-specific lesions of the Anterior Commissure versus non-specific lesions of Interlabial Sulci in patients with impaired vulvar skin.||||0.0000
72394102|NCT04180488|144294704|SUPERIORITY|A hierarchical testing procedure was used to control the overall type I error.|Odds Ratio (OR)|2.848||||0.0075|TWO_SIDED|95.0|1.301|6.234||Threshold for significance at 2-sided 0.05 level.|Cochran-Mantel-Haenszel|||CMH test was performed on the association between the responder status and intervention group, adjusted by baseline disease severity (UAS7 \<28, \>=28), presence of angioedema at baseline, and region.||6.234|1.301|0.0075
72621339|NCT02732145|144773192|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of the Anterior Commissure versus non-specific lesions of Labia Minora in patients with impaired vulvar skin?||||||0.0006|||||||t-test proportion|||Parameter: The difference in the incidence of non-specific lesions of the Anterior Commissure versus non-specific lesions of Labia Minora in patients with impaired vulvar skin.||||0.0006
72621340|NCT02732145|144773192|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of the Anterior Commissure versus non-specific lesions of the Posterior Commissure in patients with impaired vulvar skin?||||||0|||||||t-test proportion|||Parameter: The difference in the incidence of non-specific lesions of the Anterior Commissure versus non-specific lesions of the Posterior Commissure in patients with impaired vulvar skin.||||0.0000
72621341|NCT02732145|144773192|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of Interlabial Sulci versus non-specific lesions of the Posterior Commissure in patients with impaired vulvar skin?||||||0.0003|||||||t-test proportion|||Parameter: The difference in the incidence of non-specific lesions of Interlabial Sulci versus non-specific lesions of the Posterior Commissure in patients with impaired vulvar skin.||||0.0003
72621342|NCT02732145|144773192|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of Labia Minora versus non-specific lesions of the Posterior Commissure in patients with impaired vulvar skin?||||||0|||||||t-test proportion|||Parameter: The difference in the incidence of non-specific lesions of Labia Minora versus non-specific lesions of the Posterior Commissure in patients with impaired vulvar skin.||||0.0000
72502824|NCT01193335|144536068|SUPERIORITY_OR_OTHER||Percent Difference|4.65|||||TWO_SIDED|95.0|0.04|11.48||||||Serotype 3: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||11.48|0.04|
72502825|NCT01193335|144536068|SUPERIORITY_OR_OTHER||Percent Difference|-16.06|||||TWO_SIDED|95.0|-29.15|-2.6||||||Serotype 5: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||-2.60|-29.15|
72502826|NCT01193335|144536068|SUPERIORITY_OR_OTHER||Percent Difference|2.27|||||TWO_SIDED|95.0|-1.96|7.97||||||Serotype 6A: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||7.97|-1.96|
72502827|NCT01193335|144536068|SUPERIORITY_OR_OTHER||Percent Difference|-2.15|||||TWO_SIDED|95.0|-7.55|2.1||||||Serotype 7F: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||2.10|-7.55|
72502828|NCT01193335|144536068|SUPERIORITY_OR_OTHER||Percent Difference|-1.09|||||TWO_SIDED|95.0|-5.96|3.18||||||Serotype 19A: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||3.18|-5.96|
72502829|NCT01193335|144536069|SUPERIORITY_OR_OTHER||Percent Difference|-9.08|||||TWO_SIDED|95.0|-25.11|7.49||||||Serotype 4: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||7.49|-25.11|
72621343|NCT02732145|144773192|SUPERIORITY|Question: Is there a difference in the incidence of specific lesion of the Anterior Commissure versus specific lesions of Interlabial Sulci in patients with vulvar dermatosis?||||||0.3053|||||||t-test proportion|||Parameter: The difference in the incidence of specific lesions of the Anterior Commissure versus specific lesions of Interlabial Sulci in patients with vulvar dermatosis.||||0.3053
72621344|NCT02732145|144773192|SUPERIORITY|Question: Is there a difference in the incidence of specific lesion of the Anterior Commissure versus specific lesions of Labia Minora in patients with vulvar dermatosis?||||||0.7758|||||||t-test proportion|||Parameter: The difference in the incidence of specific lesions of the Anterior Commissure versus specific lesions of Labia Minora in patients with vulvar dermatosis.||||0.7758
72502830|NCT01193335|144536069|SUPERIORITY_OR_OTHER||Percent Difference|-5.39|||||TWO_SIDED|95.0|-21.03|10.4||||||Serotype 6B: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||10.40|-21.03|
72394103|NCT04180488|144294704|SUPERIORITY|A hierarchical testing procedure was used to control the overall type I error.|Odds Ratio (OR)|3.137||||0.0045|TWO_SIDED|95.0|1.371|7.176||Threshold for significance at 2-sided 0.05 level.|Cochran-Mantel-Haenszel|||CMH test was performed on the association between the responder status and intervention group, adjusted by baseline disease severity (UAS7 \<28, \>=28), presence of angioedema at baseline, and region.||7.176|1.371|0.0045
72394104|NCT04180488|144294705|SUPERIORITY|A hierarchical testing procedure was used to control the overall type I error.|Odds Ratio (OR)|2.908||||0.0199|TWO_SIDED|95.0|1.173|7.209||Threshold for significance at 2-sided 0.05 level.|Cochran-Mantel-Haenszel|||CMH test was performed on the association between the responder status and intervention group, adjusted by baseline disease severity (UAS7 \<28, \>=28), presence of angioedema at baseline, and region.||7.209|1.173|0.0199
72394105|NCT04180488|144294705|SUPERIORITY|A hierarchical testing procedure was used to control the overall type I error.|Odds Ratio (OR)|2.677||||0.0187|TWO_SIDED|95.0|1.127|6.359||Threshold for significance at 2-sided 0.05 level.|Cochran-Mantel-Haenszel|||CMH test was performed on the association between the responder status and intervention group, adjusted by baseline disease severity (UAS7 \<28, \>=28), presence of angioedema at baseline, and region.||6.359|1.127|0.0187
72394106|NCT04180488|144294706|SUPERIORITY|A hierarchical testing procedure was used to control the overall type I error.|LS Mean Difference|0.93||||0.194|TWO_SIDED|95.0|-0.48|2.34||Threshold for significance at 2-sided 0.05 level.|ANCOVA|||Analyzed by fitting an ANCOVA model with the corresponding baseline value, intervention group, presence of angioedema at baseline, and regions as covariates.||2.34|-0.48|0.1940
72394107|NCT04180488|144294707|SUPERIORITY|A hierarchical testing procedure was used to control the overall type I error.|LS Mean Difference|-2.37||||0.0377|TWO_SIDED|95.0|-4.6|-0.13||Threshold for significance at 2-sided 0.05 level.|ANCOVA|||Analyzed by fitting an ANCOVA model with the corresponding baseline value, intervention group, presence of angioedema at baseline, and regions as covariates.||-0.13|-4.60|0.0377
72564188|NCT01040793|144660104|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.119|STANDARD_ERROR_OF_MEAN|0.037||0.0013||95.0|0.047|0.191|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 10 mcg minus Placebo|||0.191|0.047|0.0013
72394108|NCT04180488|144294708|SUPERIORITY|A hierarchical testing procedure was used to control the overall type I error.|LS Mean Difference|-5.02||||0.0223|TWO_SIDED|95.0|-9.32|-0.72||Threshold for significance at 2-sided 0.05 level.|ANCOVA|||Analyzed by fitting an ANCOVA model with the corresponding baseline value, intervention group, presence of angioedema at baseline, and regions as covariates.||-0.72|-9.32|0.0223
72394109|NCT04180488|144294709|SUPERIORITY|A hierarchical testing procedure was used to control the overall type I error.|Odds Ratio (OR)|2.645||||0.0215|TWO_SIDED|95.0|1.154|6.061||Threshold for significance at 2-sided 0.05 level.|Cochran-Mantel-Haenszel|||CMH test was performed on the association between the responder status and intervention group, adjusted by baseline disease severity (UAS7 \<28, \>=28), presence of angioedema at baseline, and region.||6.061|1.154|0.0215
72394110|NCT04180488|144294710|SUPERIORITY|A hierarchical testing procedure was used to control the overall type I error.|Odds Ratio (OR)|1.872||||0.0971|TWO_SIDED|95.0|0.893|3.923||Threshold for significance at 2-sided 0.05 level.|Cochran-Mantel-Haenszel|||CMH test was performed on the association between the responder status and intervention group, adjusted by baseline disease severity (UAS7 \<28, \>=28), presence of angioedema at baseline, and region.||3.923|0.893|0.0971
72394111|NCT01104493|144294768|NON_INFERIORITY_OR_EQUIVALENCE|H0 (null): Rate difference ≥ 5 percentage points This corresponded to a null hypothesis of: HA (alternative): rate difference \< 5 percentage points.|rate difference|0.4|||||TWO_SIDED|95.0|-5.2|2.6|||score statistic|||Comparison of the rate of fever between the 2 treatment groups was based on the upper limit of the two-sided 95% exact confidence intervals (CIs) for the rate increase (Monovalent vaccine minus Placebo) evaluated against the prespecified equivalence criterion of 5 percentage points.||2.6|-5.2|
72394112|NCT04677374|144294780|OTHER|||||||0.044|||||||Test of proportions|||||||0.044
72394113|NCT04677374|144294780|OTHER|||||||0.259|||||||Test of proportions|||||||0.259
72394114|NCT04677374|144294780|OTHER|||||||0.044|||||||Test of proportions|||||||0.044
72394115|NCT04677374|144294781|OTHER||Hazard Ratio (HR)|2.23|||||TWO_SIDED|95.0|1.01|4.93||||||||4.93|1.01|
72394116|NCT04677374|144294781|OTHER||Hazard Ratio (HR)|1.66|||||TWO_SIDED|95.0|0.69|4.0||||||||4.00|0.69|
72394117|NCT04677374|144294781|OTHER||Hazard Ratio (HR)|2.31|||||TWO_SIDED|95.0|1.0|5.36||||||||5.36|1.00|
72465678|NCT04159805|144454327|SUPERIORITY||Difference in LS Mean|-3.97|||=|0.815|TWO_SIDED|95.0|-37.34|29.4||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 10||29.40|-37.34|=0.815
72465679|NCT04159805|144454327|SUPERIORITY||Difference in LS Mean|-4.31|||=|0.794|TWO_SIDED|95.0|-36.84|28.22||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 10||28.22|-36.84|=0.794
72394118|NCT05620563|144294818|SUPERIORITY||Posterior Mean Difference|0.3|||||TWO_SIDED|95.0|-0.28|0.87|||||Posterior mean difference with 95% credible interval is reported.|||0.87|-0.28|
72394119|NCT05620563|144294819|SUPERIORITY||Posterior Mean Difference|-0.15|||||TWO_SIDED|95.0|-1.13|0.82|||||Posterior mean difference with 95% credible interval is reported.|||0.82|-1.13|
72394120|NCT05620563|144294820|SUPERIORITY||Posterior Mean Difference|-0.47|||||TWO_SIDED|95.0|-0.99|0.05|||||Posterior mean difference with 95% credible interval is reported.|||0.05|-0.99|
72394121|NCT05620563|144294821|SUPERIORITY||Posterior Mean Difference|-0.55|||||TWO_SIDED|95.0|-3.82|2.69|||||Posterior mean difference with 95% credible interval is reported.|||2.69|-3.82|
72394122|NCT05620563|144294822|SUPERIORITY||Posterior Mean Difference|0.09|||||TWO_SIDED|95.0|-0.33|0.51|||||Posterior mean difference with 95% credible interval is reported.|||0.51|-0.33|
72394123|NCT05620563|144294823|SUPERIORITY||Posterior Mean Difference|0.3|||||TWO_SIDED|95.0|-0.35|0.95|||||Posterior mean difference with 95% credible interval is reported.|||0.95|-0.35|
72394124|NCT05620563|144294824|SUPERIORITY||Posterior Mean Difference|2.2|||||TWO_SIDED|95.0|-5.7|9.99|||||Posterior mean difference with 95% credible interval is reported.|||9.99|-5.70|
72465680|NCT04159805|144454327|SUPERIORITY||Difference in LS Mean|-36.78|||=|0.033|TWO_SIDED|95.0|-70.48|-3.08||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 12||-3.08|-70.48|=0.033
72465681|NCT04159805|144454327|SUPERIORITY||Difference in LS Mean|-10.79|||=|0.513|TWO_SIDED|95.0|-43.26|21.67||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Week 12||21.67|-43.26|=0.513
72465682|NCT04159805|144454327|SUPERIORITY||Difference in LS Mean|-56.21|||=|0.002|TWO_SIDED|95.0|-91.69|-20.73||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Week 14||-20.73|-91.69|=0.002
72465683|NCT04159805|144454327|SUPERIORITY||Difference in LS Mean|-36.94|||=|0.036|TWO_SIDED|95.0|-71.39|-2.48||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Week 14||-2.48|-71.39|=0.036
72465684|NCT04159805|144454327|SUPERIORITY||Difference in LS Mean|-62.98|||=|0.001|TWO_SIDED|95.0|-100.64|-25.31||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Week 16||-25.31|-100.64|=0.001
72465685|NCT04159805|144454327|SUPERIORITY||Difference in LS Mean|-28.81|||=|0.13|TWO_SIDED|95.0|-66.12|8.51||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Week 16||8.51|-66.12|=0.130
72465686|NCT01393613|144454332|SUPERIORITY_OR_OTHER|||||||0.0093|||||||Mixed Models Analysis|MMRM analysis fixed effect of treatment, trial site, visit, treatment visit interaction, Baseline value, Baseline visit interaction as covariates.||Statistical analysis to compare the average effect analysis for brexpiprazole 2 mg/day and 4 mg/day and placebo combined treatment groups at Week 6. The primary analysis was performed by fitting a Mixed Model Repeated Measures (MMRM) with an unstructured variance covariance structure. The model included fixed class effect terms for treatment, trial site, visit week, baseline, baseline and visit interaction and an interaction term of treatment by visit week.||||0.0093
72465687|NCT01393613|144454332|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.47||||0.0022|TWO_SIDED|95.0|-10.6|-2.35|||Mixed Models Analysis|MMRM analysis fixed effect of treatment, trial site, visit, treatment visit interaction, Baseline value, Baseline visit interaction as covariates.||Statistical analysis to compare brexpiprazole 4mg/day and placebo was performed at Week 6.||-2.35|-10.6|0.0022
72465688|NCT01393613|144454332|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.08||||0.1448|TWO_SIDED|95.0|-7.23|1.07|||Mixed Models Analysis|MMRM analysis fixed effect of treatment, trial site, visit, treatment visit interaction, Baseline value, Baseline visit interaction as covariates.||Statistical analysis to compare brexpiprazole 2mg/day and placebo was performed at Week 6.||1.07|-7.23|0.1448
72465689|NCT01393613|144454332|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.37||||0.1588|TWO_SIDED|95.0|-8.06|1.32|||Mixed Models Analysis|MMRM analysis fixed effect of treatment, trial site, visit, treatment visit interaction, Baseline value, Baseline visit interaction as covariates.||Statistical analysis to compare brexpiprazole 1mg/day and placebo was performed at Week 6. MMRM analysis fixed effect of treatment, clinical visit, trial site, treatment visit interaction, Baseline value, and Baseline visit interaction as covariates.||1.32|-8.06|0.1588
72502831|NCT01193335|144536069|SUPERIORITY_OR_OTHER||Percent Difference|6.53|||||TWO_SIDED|95.0|-7.16|21.16||||||Serotype 9V: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||21.16|-7.16|
72394125|NCT05620563|144294825|SUPERIORITY||Posterior Mean Difference|-0.07|||||TWO_SIDED|95.0|-0.39|0.24|||||Posterior mean difference with 95% credible interval is reported.|||0.24|-0.39|
72394126|NCT05620563|144294826|SUPERIORITY||Posterior Mean Difference|24.16|||||TWO_SIDED|95.0|-115.48|166.06|||||Posterior mean difference with 95% credible interval is reported.|||166.06|-115.48|
72502832|NCT01193335|144536069|SUPERIORITY_OR_OTHER||Percent Difference|-7.88|||||TWO_SIDED|95.0|-20.28|3.35||||||Serotype 14: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||3.35|-20.28|
72502833|NCT01193335|144536069|SUPERIORITY_OR_OTHER||Percent Difference|-10.73|||||TWO_SIDED|95.0|-29.01|8.11||||||Serotype 18C: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||8.11|-29.01|
72502834|NCT01193335|144536069|SUPERIORITY_OR_OTHER||Percent Difference|7.11|||||TWO_SIDED|95.0|-1.52|17.65||||||Serotype 19F: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||17.65|-1.52|
72502835|NCT01193335|144536069|SUPERIORITY_OR_OTHER||Percent Difference|-13.37|||||TWO_SIDED|95.0|-29.57|3.31||||||Serotype 23F: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||3.31|-29.57|
72502836|NCT01193335|144536069|SUPERIORITY_OR_OTHER||Percent Difference|8.09|||||TWO_SIDED|95.0|-0.52|17.81||||||Serotype 1: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||17.81|-0.52|
72502837|NCT01193335|144536069|SUPERIORITY_OR_OTHER||Percent Difference|-7.38|||||TWO_SIDED|95.0|-22.86|8.29||||||Serotype 3: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||8.29|-22.86|
72502838|NCT01193335|144536069|SUPERIORITY_OR_OTHER||Percent Difference|0.51|||||TWO_SIDED|95.0|-8.82|10.08||||||Serotype 5: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||10.08|-8.82|
72502839|NCT01193335|144536069|SUPERIORITY_OR_OTHER||Percent Difference|-20.19|||||TWO_SIDED|95.0|-35.45|-3.95||||||Serotype 6A: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||-3.95|-35.45|
72502840|NCT01193335|144536069|SUPERIORITY_OR_OTHER||Percent Difference|5.25|||||TWO_SIDED|95.0|-8.5|19.06||||||Serotype 7F: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||19.06|-8.50|
72465690|NCT01393613|144454333|SUPERIORITY_OR_OTHER|||||||0.0069|||||||Mixed Models Analysis|MMRM analysis fixed effect of treatment, trial site, visit, treatment visit interaction, Baseline value, Baseline visit interaction as covariates.||Statistical analysis to compare the average effect analysis for brexpiprazole 2 mg/day and 4 mg/day and placebo combined treatment groups at Week 6.||||0.0069
72370597|NCT00488683|144251633|SUPERIORITY_OR_OTHER||R-square|0.0||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between memory B cells one month after primary vaccination and rise from pre-booster levels in serogroup specific IgG concentration one month after booster vaccination for the serogroup Y||||
72370598|NCT00488683|144251634|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|-0.14||||0.68||95.0|||||Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccination and serogroup specific plasma cells one week after booster vaccination for the serogroup A||||0.68
72370599|NCT00488683|144251634|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|0.44||||0.09||95.0|||||Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccination and serogroup specific plasma cells one week after booster vaccination for the serogroup C||||0.09
72370600|NCT00488683|144251634|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|0.11||||0.69||95.0|||||Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccination and serogroup specific plasma cells one week after booster vaccination for the serogroup W-135||||0.69
72370601|NCT00488683|144251634|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|0.38||||0.2||95.0|||||Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccination and serogroup specific plasma cells one week after booster vaccination for the serogroup Y||||0.20
72370602|NCT00488683|144251634|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|-0.05||||0.88||95.0|||||Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccination and serogroup specific plasma cells one week after booster vaccination for the serogroup A||||0.88
72370603|NCT00488683|144251634|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.41||||0.12||95.0|||||Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccination and serogroup specific plasma cells one week after booster vaccination for the serogroup C||||0.12
72370604|NCT00488683|144251634|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.25||||0.37||95.0|||||Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccination and serogroup specific plasma cells one week after booster vaccination for the serogroup W-135||||0.37
72370605|NCT00488683|144251634|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.28||||0.36||95.0|||||Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccination and serogroup specific plasma cells one week after booster vaccination for the serogroup Y||||0.36
72370606|NCT00488683|144251634|SUPERIORITY_OR_OTHER||R-square|0.02||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and serogroup specific plasma cells one week after booster vaccination for the serogroup A||||
72370607|NCT00488683|144251634|SUPERIORITY_OR_OTHER||R-square|0.2||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and serogroup specific plasma cells one week after booster vaccination for the serogroup C||||
72370608|NCT00488683|144251634|SUPERIORITY_OR_OTHER||R-square|0.01||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and serogroup specific plasma cells one week after booster vaccination for the serogroup W-135||||
72370609|NCT00488683|144251634|SUPERIORITY_OR_OTHER||R-square|0.15||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and serogroup specific plasma cells one week after booster vaccination for the serogroup Y||||
72370610|NCT00488683|144251634|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|1.0||||||95.0|||||Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccination and memory B cells one week after booster vaccination for the serogroup C||||
72370611|NCT00488683|144251634|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|1.0||||||95.0|||||Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccination and memory B cells one week after booster vaccination for the serogroup C||||
72370612|NCT00488683|144251634|SUPERIORITY_OR_OTHER||R-square|1.0||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and memory B cells one week after booster vaccination for the serogroup C||||
72370613|NCT00488683|144251634|SUPERIORITY_OR_OTHER||R-square|0.0||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and memory B cells one week after booster vaccination for the serogroup W-135||||
72370614|NCT00488683|144251634|SUPERIORITY_OR_OTHER||R-square|0.0||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and memory B cells one week after booster vaccination for the serogroup Y||||
72370615|NCT00488683|144251634|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|-0.08||||0.79||95.0|||||Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccination and hSBA titers one week after booster vaccination for the serogroup A||||0.79
72370616|NCT00488683|144251634|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|0.35||||0.16||95.0|||||Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccination and hSBA titers one week after booster vaccination for the serogroup C||||0.16
72370617|NCT00488683|144251634|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|0.48||||0.1||95.0|||||Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccination and hSBA titers one week after booster vaccination for the serogroup W-135||||0.10
72370618|NCT00488683|144251634|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|0.98||||0.003||95.0|||||Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccination and hSBA titers one week after booster vaccination for the serogroup Y||||0.003
72370619|NCT00488683|144251634|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|-0.03||||0.91||95.0|||||Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccination and hSBA titers one week after booster vaccination for the serogroup A||||0.91
72370620|NCT00488683|144251634|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.57||||0.01||95.0|||||Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccination and hSBA titers one week after booster vaccination for the serogroup C||||0.01
72394127|NCT05620563|144294827|SUPERIORITY||Posterior Mean Difference|-0.01|||||TWO_SIDED|95.0|-0.09|0.08|||||Posterior mean difference with 95% credible interval is reported.|||0.08|-0.09|
72465691|NCT01393613|144454333|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.38||||0.0015|TWO_SIDED|95.0|-0.62|-0.15|||Mixed Models Analysis|MMRM analysis fixed effect of treatment, trial site, visit, treatment visit interaction, Baseline value, Baseline visit interaction as covariates.||Statistical analysis to compare brexpiprazole 4mg/day and placebo was performed at Week 6. The analysis of this key secondary endpoint was conducted if both comparisons of brexpiprazole 4 mg/day vs placebo and brexpiprazole 2 mg/day vs placebo of the primary endpoint were significant. Because only the comparison of brexpiprazole 4 mg/day vs placebo met the threshold in the primary analysis, the following analysis is not part of the formal statistical testing and is descriptive only.||-0.15|-0.62|0.0015
72465692|NCT01393613|144454333|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.19||||0.1269|TWO_SIDED|95.0|-0.42|-0.05|||Mixed Models Analysis|MMRM analysis fixed effect of treatment, trial site, visit, treatment visit interaction, Baseline value, Baseline visit interaction as covariates.||Statistical analysis to compare brexpiprazole 2mg/day and placebo was performed at Week 6.||-0.05|-0.42|0.1269
72465693|NCT01393613|144454333|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.4449|TWO_SIDED|95.0|-0.37|0.16|||Mixed Models Analysis|MMRM analysis fixed effect of treatment, trial site, visit, treatment visit interaction, Baseline value, Baseline visit interaction as covariates.||Statistical analysis to compare brexpiprazole 1mg/day and placebo was performed at Week 6.||0.16|-0.37|0.4449
72465694|NCT01393613|144454334|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.59||||0.0005|TWO_SIDED|95.0|2.02|7.17|||Mixed Models Analysis|MMRM analysis fixed effect of treatment, trial site, visit, treatment visit interaction, Baseline value, Baseline visit interaction as covariates.||Statistical analysis to compare brexpiprazole 4mg/day and placebo was performed at Week 6.||7.17|2.02|0.0005
72465695|NCT01393613|144454334|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.0||||0.1286|TWO_SIDED|95.0|-0.58|4.59|||Mixed Models Analysis|MMRM analysis fixed effect of treatment, trial site, visit, treatment visit interaction, Baseline value, Baseline visit interaction as covariates.||Statistical analysis to compare brexpiprazole 2mg/day and placebo was performed at Week 6.||4.59|-0.58|0.1286
72465696|NCT01393613|144454334|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.21||||0.0332|TWO_SIDED|95.0|0.26|6.16|||Mixed Models Analysis|MMRM analysis fixed effect of treatment, trial site, visit, treatment visit interaction, Baseline value, Baseline visit interaction as covariates.||Statistical analysis to compare brexpiprazole 1mg/day and placebo was performed at Week 6.||6.16|0.26|0.0332
72465697|NCT01393613|144454335|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.7||||0.0166|TWO_SIDED|95.0|-3.08|-0.31|||Mixed Models Analysis|MMRM analysis fixed effect of treatment, trial site, visit, treatment visit interaction, Baseline value, Baseline visit interaction as covariates.||Statistical analysis to compare brexpiprazole 4mg/day and placebo was performed at Week 6.||-0.31|-3.08|0.0166
72502841|NCT01193335|144536069|SUPERIORITY_OR_OTHER||Percent Difference|-3.14|||||TWO_SIDED|95.0|-17.51|11.13||||||Serotype 19A: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||11.13|-17.51|
72502842|NCT01193335|144536070|SUPERIORITY_OR_OTHER||Percent Difference|0.0|||||TWO_SIDED|95.0|-5.59|5.89||||||Serotype 4: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||5.89|-5.59|
72564189|NCT01040793|144660105|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.265|STANDARD_ERROR_OF_MEAN|0.035|<|0.0001||95.0|0.196|0.333|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 5 mcg minus Placebo|||0.333|0.196|<0.0001
72564190|NCT01040793|144660105|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.281|STANDARD_ERROR_OF_MEAN|0.035|<|0.0001||95.0|0.212|0.35|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 10 mcg minus Placebo|||0.350|0.212|<0.0001
72465698|NCT01393613|144454335|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.47||||0.5101|TWO_SIDED|95.0|-1.86|0.93|||Mixed Models Analysis|MMRM analysis fixed effect of treatment, trial site, visit, treatment visit interaction, Baseline value, Baseline visit interaction as covariates.||Statistical analysis to compare brexpiprazole 2mg/day and placebo was performed at Week 6.||0.93|-1.86|0.5101
72564191|NCT01040793|144660106|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.281|STANDARD_ERROR_OF_MEAN|0.063|<|0.0001||95.0|0.156|0.405|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 5 mcg minus Placebo|||0.405|0.156|<0.0001
72564192|NCT01040793|144660106|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.291|STANDARD_ERROR_OF_MEAN|0.063|<|0.0001||95.0|0.166|0.416|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 10 mcg minus Placebo|||0.416|0.166|<0.0001
72564193|NCT01040793|144660107|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.58|STANDARD_ERROR_OF_MEAN|0.07|<|0.0001||95.0|0.441|0.719|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 5 mcg minus Placebo|||0.719|0.441|<0.0001
72564194|NCT01040793|144660107|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.552|STANDARD_ERROR_OF_MEAN|0.071|<|0.0001||95.0|0.412|0.691|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 10 mcg minus Placebo|||0.691|0.412|<0.0001
72370621|NCT00488683|144251634|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.39||||0.19||95.0|||||Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccination and hSBA titers one week after booster vaccination for the serogroup W-135||||0.19
72370622|NCT00488683|144251634|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.89||||0.04||95.0|||||Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccination and hSBA titers one week after booster vaccination for the serogroup Y||||0.04
72502843|NCT01193335|144536070|SUPERIORITY_OR_OTHER||Percent Difference|0.08|||||TWO_SIDED|95.0|-6.81|7.37||||||Serotype 6B: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||7.37|-6.81|
72394128|NCT00869206|144294828|NON_INFERIORITY_OR_EQUIVALENCE|Based on the published data on the effect of a standard of dosing schedule of \> zoledronic acid compared to placebo, we choose ∆= 7%, πT= 42%, and πS= 35%. With a total of 1230 eligible patients (615 per arm), the probability of rejecting the null hypothesis using a one-sided test is at most 0.05 (Type I error α) when θ≥ 7% and the probability of rejecting the null hypothesis (the power) is at least 82% when θ≤0|||||<=|0.05|||||||Cochran-Mantel-Haenszel|||||||<=.05
72394129|NCT00869206|144294829|SUPERIORITY_OR_OTHER||Slope|-0.00394|STANDARD_ERROR_OF_MEAN|0.00962||0.68|TWO_SIDED||||||Mixed Models Analysis|Model is adjusted for tumor type, baseline creatinine, prior SREs, prior bisphosphonates, age, gender, race, BSA, and baseline performance status||||||0.68
72394130|NCT00869206|144294830|SUPERIORITY_OR_OTHER||Slope|0.0016|STANDARD_ERROR_OF_MEAN|0.0034||0.64|TWO_SIDED||||||Mixed Models Analysis|Adjusted for tumor type, baseline creatinine, prior SRE, prior bisphosphonates, age, gender, BSA, race, and baseline performance status||||||0.64
72394131|NCT00869206|144294832|SUPERIORITY||Mean Difference (Final Values)|0.7||||0.1|TWO_SIDED|95.0|-0.3|1.7|||Cochran-Mantel-Haenszel|||||1.7|-0.3|0.10
72394132|NCT00411645|144294850|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.902||||0.789|TWO_SIDED|95.0|0.424|1.92||The p-value is from the Cochran-Mantel-Haenszel test, adjusting for recipient CMV serostatus (R+ or R-) and transplant type (myeloablative or non-myeloablative/reduced intensity).|Cochran-Mantel-Haenszel||Mantel-Haenszel odds ratio for maribavir versus placebo|||1.920|0.424|0.789
72394133|NCT00411645|144294851|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.721||||0.056|TWO_SIDED|95.0|0.515|1.008||The p-value is from the Cochran-Mantel-Haenszel test, adjusting for recipient CMV serostatus (R+ or R-) and transplant type (myeloablative or non-myeloablative/reduced intensity).|Cochran-Mantel-Haenszel||Mantel-Haenszel odds ratio for maribavir versus placebo|Analysis of pp65 antigenemia assay||1.008|0.515|0.056
72394134|NCT00411645|144294851|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.979||||0.904|TWO_SIDED|95.0|0.697|1.375||The p-value is from the Cochran-Mantel-Haenszel test, adjusting for recipient CMV serostatus (R+ or R-) and transplant type (myeloablative or non-myeloablative/reduced intensity).|Cochran-Mantel-Haenszel||Mantel-Haenszel odds ratio for maribavir versus placebo|Analysis of CMV DNA PCR assay||1.375|0.697|0.904
72394135|NCT00411645|144294851|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.838||||0.289|TWO_SIDED|95.0|0.606|1.161||The p-value is from the Cochran-Mantel-Haenszel test, adjusting for recipient CMV serostatus (R+ or R-) and transplant type (myeloablative or non-myeloablative/reduced intensity).|Cochran-Mantel-Haenszel||Mantel-Haenszel odds ratio for maribavir versus placebo|Analysis of pp65 antigenemia or CMV DNA PCR assay||1.161|0.606|0.289
72502844|NCT01193335|144536070|SUPERIORITY_OR_OTHER||Percent Difference|-1.55|||||TWO_SIDED|95.0|-10.87|7.44||||||Serotype 9V: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||7.44|-10.87|
72621345|NCT02732145|144773192|SUPERIORITY|Question: Is there a difference in the incidence of specific lesion of the Anterior Commissure versus specific lesions of the Posterior Commissure in patients with vulvar dermatosis?||||||0.6676|||||||t-test proportion|||Parameter: The difference in the incidence of specific lesions of the Anterior Commissure versus specific lesions of the Posterior Commissure in patients with vulvar dermatosis.||||0.6676
72621346|NCT02732145|144773192|SUPERIORITY|Question: Is there a difference in the incidence of specific lesion of Interlabial Sulci versus specific lesions of Labia Minora in patients with vulvar dermatosis?||||||0.4577|||||||t-test proportion|||Parameter: The difference in the incidence of specific lesions of Interlabial Sulci versus specific lesions of Labia Minora in patients with vulvar dermatosis.||||0.4577
72394136|NCT00411645|144294851|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.891||||0.493|TWO_SIDED|95.0|0.64|1.239||The p-value is from the Cochran-Mantel-Haenszel test, adjusting for recipient CMV serostatus (R+ or R-) and transplant type (myeloablative or non-myeloablative/reduced intensity).|Cochran-Mantel-Haenszel||Mantel-Haenszel odds ratio for maribavir versus placebo|Analysis of initiation of anti-CMV therapy||1.239|0.640|0.493
72394137|NCT00411645|144294852|SUPERIORITY_OR_OTHER_LEGACY|||||||0.129|TWO_SIDED||||||Log Rank|||||||0.129
72394138|NCT00411645|144294852|SUPERIORITY_OR_OTHER_LEGACY||Adjusted hazard ratio|0.83||||0.13|TWO_SIDED|95.0|0.65|1.06||The p-value from Wald Chi-Square test for treatment effect.|Wald Chi-squared||Maribavir versus placebo; based on Cox's proportional hazards regression model: time = recipient CMV serostatus (R+ or R-) + transplant type (myeloablative or non-myeloablative/reduced intensity) + treatment.|||1.06|0.65|0.130
72394139|NCT00411645|144294853|SUPERIORITY_OR_OTHER_LEGACY|||||||0.542|TWO_SIDED|||||The p-value is from the Cochran-Mantel-Haenszel test, adjusting for recipient CMV serostatus (R+ or R-) and transplant type (myeloablative or non-myeloablative/reduced intensity).|Cochran-Mantel-Haenszel|||Analysis of 100 days post-transplant||||0.542
72502845|NCT01193335|144536070|SUPERIORITY_OR_OTHER||Percent Difference|0.0|||||TWO_SIDED|95.0|-5.94|5.94||||||Serotype 14: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||5.94|-5.94|
72502846|NCT01193335|144536070|SUPERIORITY_OR_OTHER||Percent Difference|-1.61|||||TWO_SIDED|95.0|-8.66|4.25||||||Serotype 18C: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||4.25|-8.66|
72502847|NCT01193335|144536070|SUPERIORITY_OR_OTHER||Percent Difference|-6.64|||||TWO_SIDED|95.0|-17.93|3.56||||||Serotype 19F: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||3.56|-17.93|
72502848|NCT01193335|144536070|SUPERIORITY_OR_OTHER||Percent Difference|0.05|||||TWO_SIDED|95.0|-6.74|7.04||||||Serotype 23F: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||7.04|-6.74|
72502849|NCT01193335|144536070|SUPERIORITY_OR_OTHER||Percent Difference|-6.48|||||TWO_SIDED|95.0|-16.37|2.75||||||Serotype 1: CI Parameter was percent difference between the groups. Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||2.75|-16.37|
72502850|NCT01193335|144536070|SUPERIORITY_OR_OTHER||Percent Difference|1.27|||||TWO_SIDED|95.0|-3.37|6.85||||||Serotype 3: CI Parameter was percent difference between the groups. Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||6.85|-3.37|
72394140|NCT00411645|144294853|SUPERIORITY_OR_OTHER_LEGACY|||||||0.637|TWO_SIDED|||||The p-value is from the Cochran-Mantel-Haenszel test, adjusting for recipient CMV serostatus (R+ or R-) and transplant type (myeloablative or non-myeloablative/reduced intensity).|Cochran-Mantel-Haenszel|||Analysis of 6 months post-transplant||||0.637
72394141|NCT00411645|144294853|SUPERIORITY_OR_OTHER_LEGACY|||||||0.825|TWO_SIDED|||||The p-value is from the Cochran-Mantel-Haenszel test, adjusting for recipient CMV serostatus (R+ or R-) and transplant type (myeloablative or non-myeloablative/reduced intensity).|Cochran-Mantel-Haenszel|||Analysis of 12 months post-transplant||||0.825
72394142|NCT00411645|144294854|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.669||||0.022|TWO_SIDED|95.0|0.474|0.946||The p-value is from the Cochran-Mantel-Haenszel test, adjusting for recipient CMV serostatus (R+ or R-) and transplant type (myeloablative or non-myeloablative/reduced intensity).|Cochran-Mantel-Haenszel||Mantel-Haenszel odds ratio for maribavir versus placebo|Analysis of pp65 antigenemia assay||0.946|0.474|0.022
72394143|NCT00411645|144294854|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.878||||0.468|TWO_SIDED|95.0|0.617|1.247||The p-value is from the Cochran-Mantel-Haenszel test, adjusting for recipient CMV serostatus (R+ or R-) and transplant type (myeloablative or non-myeloablative/reduced intensity).|Cochran-Mantel-Haenszel||Mantel-Haenszel odds ratio for maribavir versus placebo|Analysis of CMV DNA PCR assay||1.247|0.617|0.468
72394144|NCT00411645|144294854|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.772||||0.125|TWO_SIDED|95.0|0.555|1.075||The p-value is from the Cochran-Mantel-Haenszel test, adjusting for recipient CMV serostatus (R+ or R-) and transplant type (myeloablative or non-myeloablative/reduced intensity).|Cochran-Mantel-Haenszel||Mantel-Haenszel odds ratio for maribavir versus placebo|Analysis of pp65 antigenemia assay or CMV DNA PCR assay||1.075|0.555|0.125
72394145|NCT00411645|144294854|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.731||||0.069|TWO_SIDED|95.0|0.521|1.026||The p-value is from the Cochran-Mantel-Haenszel test, adjusting for recipient CMV serostatus (R+ or R-) and transplant type (myeloablative or non-myeloablative/reduced intensity).|Cochran-Mantel-Haenszel||Mantel-Haenszel odds ratio for maribavir versus placebo|Analysis of initiation of anti-CMV therapy||1.026|0.521|0.069
72394146|NCT00411645|144294854|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.913||||0.86|TWO_SIDED|95.0|0.332|2.508||The p-value is from the Cochran-Mantel-Haenszel test, adjusting for recipient CMV serostatus (R+ or R-) and transplant type (myeloablative or non-myeloablative/reduced intensity).|Cochran-Mantel-Haenszel||Mantel-Haenszel odds ratio for maribavir versus placebo|Analysis of EC-confirmed disease||2.508|0.332|0.860
72394147|NCT00411645|144294855|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.835||||0.617|TWO_SIDED|95.0|0.411|1.693||The p-value is from the Cochran-Mantel-Haenszel test, adjusting for recipient CMV serostatus (R+ or R-) and transplant type (myeloablative or non-myeloablative/reduced intensity).|Cochran-Mantel-Haenszel||Mantel-Haenszel odds ratio for maribavir versus placebo|Analysis of 12 months post-transplant||1.693|0.411|0.617
72502851|NCT01193335|144536070|SUPERIORITY_OR_OTHER||Percent Difference|-1.34|||||TWO_SIDED|95.0|-8.36|5.14||||||Serotype 5: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||5.14|-8.36|
72394148|NCT00411645|144294856|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.048||||0.7808|TWO_SIDED|95.0|0.754|1.457||The p-value is from the Cochran-Mantel-Haenszel test, adjusting for recipient CMV serostatus (R+ or R -) and transplant type (myeloablative or non-myeloablative/reduced intensity).|Cochran-Mantel-Haenszel||Mantel-Haenszel odds ratio for maribavir versus placebo|Analysis of 100 days post-transplant||1.457|0.754|0.7808
72394149|NCT00411645|144294856|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.068||||0.6946|TWO_SIDED|95.0|0.771|1.479||The p-value is from the Cochran-Mantel-Haenszel test, adjusting for recipient CMV serostatus (R+ or R -) and transplant type (myeloablative or non-myeloablative/reduced intensity).|Cochran-Mantel-Haenszel||Mantel-Haenszel odds ratio for maribavir versus placebo|Analysis of 6 months post-transplant||1.479|0.771|0.6946
72465699|NCT01393613|144454335|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.68||||0.3938|TWO_SIDED|95.0|-2.26|0.89|||Mixed Models Analysis|MMRM analysis fixed effect of treatment, trial site, visit, treatment visit interaction, Baseline value, Baseline visit interaction as covariates.||Statistical analysis to compare brexpiprazole 1mg/day and placebo was performed at Week 6.||0.89|-2.26|0.3938
72465700|NCT01393613|144454336|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.22||||0.0231|TWO_SIDED|95.0|-2.28|-0.17|||Mixed Models Analysis|MMRM analysis fixed effect of treatment, trial site, visit, treatment visit interaction, Baseline value, Baseline visit interaction as covariates.||Statistical analysis to compare brexpiprazole 4mg/day and placebo was performed at Week 6.||-0.17|-2.28|0.0231
72465701|NCT01393613|144454336|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.77||||0.1547|TWO_SIDED|95.0|-1.83|0.29|||Mixed Models Analysis|MMRM analysis fixed effect of treatment, trial site, visit, treatment visit interaction, Baseline value, Baseline visit interaction as covariates.||Statistical analysis to compare brexpiprazole 2mg/day and placebo was performed at Week 6.||0.29|-1.83|0.1547
72502852|NCT01193335|144536070|SUPERIORITY_OR_OTHER||Percent Difference|0.0|||||TWO_SIDED|95.0|-4.73|5.04||||||Serotype 6A: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||5.04|-4.73|
72394150|NCT00411645|144294857|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.186||||0.6304|TWO_SIDED|95.0|0.592|2.375||The p-value is from the Cochran-Mantel-Haenszel test, adjusting for recipient CMV serostatus (R+ or R -) and transplant type (myeloablative or non-myeloablative/reduced intensity).|Cochran-Mantel-Haenszel||Mantel-Haenszel odds ratio for maribavir versus placebo|Analysis of 100 days post-transplant||2.375|0.592|0.6304
72465702|NCT01393613|144454336|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.78||||0.2004|TWO_SIDED|95.0|-1.98|0.42|||Mixed Models Analysis|MMRM analysis fixed effect of treatment, trial site, visit, treatment visit interaction, Baseline value, Baseline visit interaction as covariates.||Statistical analysis to compare brexpiprazole 1mg/day and placebo was performed at Week 6.||0.42|-1.98|0.2004
72502853|NCT01193335|144536070|SUPERIORITY_OR_OTHER||Percent Difference|0.0|||||TWO_SIDED|95.0|-4.48|4.55||||||Serotype 7F: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||4.55|-4.48|
72502854|NCT01193335|144536070|SUPERIORITY_OR_OTHER||Percent Difference|0.0|||||TWO_SIDED|95.0|-4.48|4.55||||||Serotype 19A: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||4.55|-4.48|
72502855|NCT01193335|144536071|SUPERIORITY_OR_OTHER||Percent Difference|-7.5|||||TWO_SIDED|95.0|-24.5|9.9||||||Serotype 4: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||9.9|-24.5|
72394151|NCT00411645|144294857|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.726||||0.1019|TWO_SIDED|95.0|0.495|1.066||The p-value is from the Cochran-Mantel-Haenszel test, adjusting for recipient CMV serostatus (R+ or R -) and transplant type (myeloablative or non-myeloablative/reduced intensity).|Cochran-Mantel-Haenszel||Mantel-Haenszel odds ratio for maribavir versus placebo|Analysis of 6 months post-transplant||1.066|0.495|0.1019
72394152|NCT03143894|144294861|SUPERIORITY||Mean Difference (Final Values)|0.47||||0.47|TWO_SIDED||||||t-test, 2 sided|||||||0.47
72394153|NCT03143894|144294862|SUPERIORITY||Mean Difference (Net)|0.69||||0.69|TWO_SIDED||||||t-test, 2 sided|||||||0.69
72394154|NCT03143894|144294863|SUPERIORITY||Mean Difference (Final Values)|0.36||||0.36|TWO_SIDED||||||t-test, 2 sided|||||||0.36
72394155|NCT04626297|144294864|OTHER||Risk Difference (RD)|0.3|||||TWO_SIDED|90.0|-10.2|11.2||||||||11.2|-10.2|
72394156|NCT04626297|144294865|OTHER||Risk Difference (RD)|12.2|||||TWO_SIDED|90.0|2.5|22.0||||||||22.0|2.5|
72394157|NCT04626297|144294866|OTHER||Risk Difference (RD)|21.7|||<|0.001|TWO_SIDED|95.0|10.3|33.2|||Cochran-Mantel-Haenszel|||||33.2|10.3|<0.001
72394158|NCT04626297|144294867|OTHER||Risk Difference (RD)|25.3|||<|0.001|TWO_SIDED|95.0|12.6|38.0|||Cochran-Mantel-Haenszel|||||38|12.6|<0.001
72394159|NCT04626297|144294868|OTHER||Risk Difference (RD)|20.3|||<|0.001|TWO_SIDED|95.0|9.0|31.6|||Cochran-Mantel-Haenszel|||||31.6|9.0|<0.001
72394160|NCT04626297|144294869|OTHER||Risk Difference (RD)|11.9||||0.138|TWO_SIDED|95.0|-3.8|27.5|||Cochran-Mantel-Haenszel|||||27.5|-3.8|0.138
72394161|NCT04626297|144294870|OTHER||LS Mean Difference|-8.21|STANDARD_ERROR_OF_MEAN|2.447|<|0.001|TWO_SIDED|95.0|-13.04|-3.39|||Mixed Models Analysis||The mixed model repeated measures (MMRM) included treatment, baseline value, visit, the interaction of the baseline value-by-visit, the interaction of treatment by-visit, geographic region, age group, baseline IGA score as fixed factors.|||-3.39|-13.04|<0.001
72394162|NCT04626297|144294871|OTHER||LS Mean Difference|-0.48|STANDARD_ERROR_OF_MEAN|0.152||0.001658|TWO_SIDED|95.0|-0.8|-0.2|||ANCOVA|||||-0.2|-0.8|0.001658
72394163|NCT02442869|144294880|SUPERIORITY||Net difference in proportion|1.73||||0.19|TWO_SIDED|95.0|-2.41|15.35|||Chi-squared|Df (1)|NNT = 5.59|Due to the large number of zeroes in the Suicidal Ideation (SI)-Current Subscale of the SSI at post (over a third of the participants reported no SI at the end of treatment), a zero-altered model was utilized which divided the outcome into (1) the probability of any SI and (2) the intensity of SI when non-zero, as done in other studies. This analysis tested the difference between the CAMS and TAU arms based on number of participants reporting no SI post Stage 1 treatment.||15.35|-2.41|0.19
72394164|NCT02442869|144294881|SUPERIORITY||Net difference in proportion|1.3||||0.25|TWO_SIDED||||||Regression, Logistic|||||||0.25
72621347|NCT02732145|144773192|SUPERIORITY|Question: Is there a difference in the incidence of specific lesion of Interlabial Sulci versus specific lesions of the Posterior Commissure in patients with vulvar dermatosis?||||||0.1681|||||||t-test proportion|||Parameter: The difference in the incidence of specific lesions of Interlabial Sulci versus specific lesions of the Posterior Commissure in patients with vulvar dermatosis.||||0.1681
72394165|NCT02442869|144294882|SUPERIORITY|Power analyses. We determined that with a sample size of 62 clients, the outcome analyses had at least 80% power to detect an effect size of 0.80 (Ahn etal., 2001)|Mean Difference (Net)|0.55||||0.035|TWO_SIDED|95.0|0.04|1.05|||t-test, 2 sided|t(60) = 2.15||||1.05|0.04|0.035
72394166|NCT05048784|144294883|OTHER|Statistical analysis was conducted to investigate the bioequivalence of treatment A (test 1) to treatment B (reference) for Cmax.|Ratio of geometric least squares means|1.009|||||TWO_SIDED|90.0|0.98|1.04|||||The geometric least squares mean ratios and confidence intervals (Cls) were obtained by taking the exponential of the corresponding differences and Cls on the natural-log (In) scale.|||1.040|0.980|
72394167|NCT05048784|144294884|OTHER|Statistical analysis was conducted to investigate the bioequivalence of treatment A (test 1) to treatment B (reference) for AUClast.|Ratio of geometric least squares means|1.01|||||TWO_SIDED|90.0|0.967|1.055|||||The geometric least squares mean ratios and Cls were obtained by taking the exponential of the corresponding differences and Cls on the In scale.|||1.055|0.967|
72394168|NCT05048784|144294885|OTHER|Statistical analysis was conducted to investigate the bioequivalence of treatment A (test 1) to treatment B (reference) for AUCinf.|Ratio of geometric least squares means|1.02|||||TWO_SIDED|90.0|0.977|1.065|||||The geometric least squares mean ratios and Cls were obtained by taking the exponential of the corresponding differences and Cls on the In scale.|||1.065|0.977|
72394169|NCT05048784|144294887|OTHER|Statistical analysis was conducted to investigate the food effect of treatment C (test 2) to treatment A (test 1) for Cmax.|Ratio of geometric least squares means|1.001|||||TWO_SIDED|90.0|0.836|1.199|||||The geometric least squares mean ratios and Cls were obtained by taking the exponential of the corresponding differences and Cls on the In scale.|||1.199|0.836|
72394170|NCT05048784|144294888|OTHER|Statistical analysis was conducted to investigate the food effect of treatment C (test 2) to treatment A (test 1) for AUClast.|Ratio of geometric least squares means|1.447|||||TWO_SIDED|90.0|1.2|1.745|||||The geometric least squares mean ratios and Cls were obtained by taking the exponential of the corresponding differences and Cls on the In scale.|||1.745|1.200|
72394171|NCT05048784|144294889|OTHER|Statistical analysis was conducted to investigate the food effect of treatment C (test 2) to treatment A (test 1) for AUCinf.|Ratio of geometric least squares means|1.484|||||TWO_SIDED|90.0|1.236|1.783|||||The geometric least squares mean ratios and Cls were obtained by taking the exponential of the corresponding differences and Cls on the In scale.|||1.783|1.236|
72394172|NCT03521934|144294890|SUPERIORITY||Hazard Ratio (HR)|0.67|||<|0.001|TWO_SIDED|95.0|0.52|0.85|||Cox proportional hazards model|||The estimates of the hazard ratio (HR) and corresponding 2-sided 95% confidence interval (CI) was to be provided by a marginal Cox proportional hazard model stratified by region and ejection fraction, with non-cardiovascular (non-CV) death treated as a competing event.||0.85|0.52|< 0.001
72394173|NCT03521934|144294891|SUPERIORITY||Hazard Ratio (HR)|0.64|||<|0.001|TWO_SIDED|95.0|0.49|0.83|||Cox proportional hazards model|||The estimates of the HR and corresponding 2-sided 95% CI was to be provided by a marginal Cox proportional hazard model stratified by region and ejection fraction, with non-CV death treated as a competing event.||0.83|0.49|< 0.001
72394174|NCT03521934|144294892|SUPERIORITY||Hazard Ratio (HR)|0.84|||=|0.36|TWO_SIDED|95.0|0.58|1.22|||Cox proportional hazards model|||The estimates of the HR and corresponding 2-sided 95% CI was to be provided by a marginal Cox proportional hazard model stratified by region and ejection fraction, with non-CV death treated as a competing event.||1.22|0.58|= 0.36
72394175|NCT03521934|144294893|SUPERIORITY||Hazard Ratio (HR)|0.72|||||TWO_SIDED|95.0|0.56|0.92||||||The estimates of the HR and corresponding 2-sided 95% CI was to be provided by a marginal Cox proportional hazard model stratified by region and ejection fraction, with non-CV death treated as a competing event.||0.92|0.56|
72394176|NCT03521934|144294894|SUPERIORITY||Hazard Ratio (HR)|0.68|||||TWO_SIDED|95.0|0.54|0.86||||||The estimates of the HR and corresponding 2-sided 95% CI was to be provided by a marginal Cox proportional hazard model stratified by region and ejection fraction, with non-CV death treated as a competing event.||0.86|0.54|
72394177|NCT03521934|144294895|SUPERIORITY||Hazard Ratio (HR)|0.82|||||TWO_SIDED|95.0|0.59|1.14||||||The estimates of the HR and corresponding 2-sided 95% CI was to be provided by a marginal Cox proportional hazard model stratified by region and ejection fraction.||1.14|0.59|
72394178|NCT03521934|144294896|SUPERIORITY||Hazard Ratio (HR)|4.1|||||TWO_SIDED|95.0|1.3|7.0||||||The change from baseline to Month 4 was analyzed using an ANCOVA model with treatment groups as factor and baseline KCCQ-12 score and randomization stratification factors as covariates.||7|1.3|
72394179|NCT03521934|144294897|SUPERIORITY||Difference in Least Squares Means|-0.16|||||TWO_SIDED|95.0|-1.3|0.98||||||Rate of decline in eGFR observed over time was analyzed by MMRM with absolute change in eGFR from baseline as the outcome, a random effect for intercept, and fixed effects for treatment, baseline value, and time.||0.98|-1.3|
72394180|NCT01750242|144294975|SUPERIORITY_OR_OTHER_LEGACY||% of leads|86.5|||||ONE_SIDED|95.0|73.7|||||||A 95% lower confidence bound was calculated on the percentage of leads where an overlap existed. A subject may have 1 or 2 leads included in the analysis.|||73.7|
72394181|NCT01750242|144294976|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-22.5|STANDARD_DEVIATION|8.7|||TWO_SIDED|95.0|-26.5|-18.4||||||Summary statistics on the UPDRS III score. A higher score is more motor dysfunction.||-18.4|-26.5|
72394182|NCT04380116|144295045|SUPERIORITY|||||||0.366|||||||ANOVA|||||||.366
72394183|NCT02602496|144295049|EQUIVALENCE|Value at week 8 minus value at week 0||||||0.9942||||||Corrected for baseline concentrations, age, gender, and body mass index|ANOVA|||||||0.9942
72394184|NCT02602496|144295049|EQUIVALENCE|Value at week 8 minus value at week 0||||||0.0062|||||||ANOVA|Corrected for baseline concentrations, age, gender, and body mass index||||||0.0062
72394185|NCT02602496|144295049|EQUIVALENCE|Value at week 8 minus value at week 0||||||0.6843|||||||ANOVA|Corrected for baseline concentrations, age, gender, and body mass index||||||0.6843
72394186|NCT02602496|144295050|EQUIVALENCE|Value at week 8 minus value at week 0||||||0.5096||||||Corrected for baseline concentrations, age, gender, and body mass index|ANOVA|||||||0.5096
72394187|NCT02602496|144295050|EQUIVALENCE|Value at week 8 minus value at week 0||||||0.2276|||||||ANOVA|Corrected for baseline concentrations, age, gender, and body mass index||||||0.2276
72394188|NCT02602496|144295050|EQUIVALENCE|Value at week 8 minus value at week 0||||||0.0006|||||||ANOVA|Corrected for baseline concentrations, age, gender, and body mass index||||||0.0006
72394189|NCT02602496|144295051|EQUIVALENCE|Value at week 8 minus value at week 0||||||0.9708||||||Corrected for baseline concentrations, age, gender, and body mass index|ANOVA|||||||0.9708
72394190|NCT02602496|144295051|EQUIVALENCE|Value at week 8 minus value at week 0||||||0.1642|||||||ANOVA|Corrected for baseline concentrations, age, gender, and body mass index||||||0.1642
72394191|NCT02602496|144295051|EQUIVALENCE|Value at week 8 minus value at week 0||||||0.6043|||||||ANOVA|Corrected for baseline concentrations, age, gender, and body mass index||||||0.6043
72394192|NCT02602496|144295052|EQUIVALENCE|Value at week 8 minus value at week 0||||||0.0868||||||Corrected for baseline concentrations, age, gender, and body mass index|ANOVA|||||||0.0868
72394193|NCT02602496|144295052|EQUIVALENCE|Value at week 8 minus value at week 0||||||0.0083|||||||ANOVA|Corrected for baseline concentrations, age, gender, and body mass index||||||0.0083
72394194|NCT02602496|144295052|EQUIVALENCE|Value at week 8 minus value at week 0||||||0.0151|||||||ANOVA|Corrected for baseline concentrations, age, gender, and body mass index||||||0.0151
72394195|NCT02602496|144295053|EQUIVALENCE|Value at week 8 minus value at week 0||||||0.9255||||||Corrected for baseline concentrations, age, gender, and body mass index|ANOVA|||||||0.9255
72394196|NCT02602496|144295053|EQUIVALENCE|Value at week 8 minus value at week 0||||||0.0454|||||||ANOVA|Corrected for baseline concentrations, age, gender, and body mass index||||||0.0454
72394197|NCT02602496|144295053|EQUIVALENCE|Value at week 8 minus value at week 0||||||0.292|||||||ANOVA|Corrected for baseline concentrations, age, gender, and body mass index||||||0.2920
72394198|NCT02602496|144295054|EQUIVALENCE|Value at week 8 minus value at week 0||||||0.2252||||||Corrected for baseline concentrations, age, gender, and body mass index|ANOVA|||||||0.2252
72394199|NCT02602496|144295054|EQUIVALENCE|Value at week 8 minus value at week 0||||||0.4715|||||||ANOVA|Corrected for baseline concentrations, age, gender, and body mass index||||||0.4715
72394200|NCT02602496|144295054|EQUIVALENCE|Value at week 8 minus value at week 0||||||0.7157|||||||ANOVA|Corrected for baseline concentrations, age, gender, and body mass index||||||0.7157
72394201|NCT02602496|144295055|EQUIVALENCE|Value at week 8 minus value at week 0||||||0.8323||||||Corrected for baseline concentrations, age, gender, and body mass index|ANOVA|||||||0.8323
72394202|NCT02602496|144295055|EQUIVALENCE|Value at week 8 minus value at week 0||||||0.8927|||||||ANOVA|Corrected for baseline concentrations, age, gender, and body mass index||||||0.8927
72394203|NCT02602496|144295055|EQUIVALENCE|Value at week 8 minus value at week 0||||||0.3173|||||||ANOVA|Corrected for baseline concentrations, age, gender, and body mass index||||||0.3173
72394204|NCT02602496|144295056|EQUIVALENCE|Value at week 8 minus value at week 0||||||0.27||||||Corrected for baseline concentrations, age and gender|ANOVA|||||||0.27
72394205|NCT05025241|144295060|OTHER||||||<|0.0001|||||||Wilcoxon Signed rank|||Efficacy endpoints were analyzed using a Wilcoxon signed rank test on the paired participant data from baseline to EOT (Visit 16), when applicable. Baseline values were based on the average non-missing values of visits 1, 2, and 3 for assessments collected at more than one visit during the Screening/Baseline period. Descriptive statistics were used to summarize the data. For total scores, waterfall plots, and histograms were created at the EOT visit with plots for all participants||||<0.0001
72465703|NCT01393613|144454337|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.49||||0.0009|TWO_SIDED|95.0|-0.78|-0.2|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenzel (CMH) row mean scores differ test controlling for study center.||Statistical analysis to compare brexpiprazole 4mg/day and placebo was performed at Week 6.||-0.20|-0.78|0.0009
72394206|NCT05025241|144295061|OTHER|||||||0.0003|||||||Wilcoxon Signed rank|||Efficacy endpoints were analyzed using a Wilcoxon signed rank test on the paired participant data from baseline to EOT (Visit 16), when applicable. Baseline values were based on the average non-missing values of visits 1, 2, and 3 for assessments collected at more than one visit during the Screening/Baseline period. Descriptive statistics were used to summarize the data. For total scores, waterfall plots, and histograms were created at the EOT visit with plots for all participants||||0.0003
72394207|NCT05025241|144295062|OTHER|Change from baseline||||||0.0156|||||||Wilcoxon Signed rank|||Efficacy endpoints were analyzed using a Wilcoxon signed rank test on the paired participant data from baseline to EOT (Visit 16), when applicable. Baseline values were based on the average non-missing values of visits 1, 2, and 3 for assessments collected at more than one visit during the Screening/Baseline period. Descriptive statistics were used to summarize the data. For total scores, waterfall plots, and histograms were created at the EOT visit with plots for all participants||||0.0156
72394208|NCT05025241|144295063|OTHER|Change from baseline||||||0.0005|||||||Wilcoxon Signed rank|||Efficacy endpoints were analyzed using a Wilcoxon signed rank test on the paired participant data from baseline to EOT (Visit 16), when applicable. Baseline values were based on the average non-missing values of visits 1, 2, and 3 for assessments collected at more than one visit during the Screening/Baseline period. Descriptive statistics were used to summarize the data. For total scores, waterfall plots, and histograms were created at the EOT visit with plots for all participants||||0.0005
72394209|NCT05025241|144295064|OTHER|||||||0.0647|||||||Wilcoxon Signed rank|||Efficacy endpoints were analyzed using a Wilcoxon signed rank test on the paired participant data from baseline to EOT (Visit 16), when applicable. Baseline values were based on the average non-missing values of visits 1, 2, and 3 for assessments collected at more than one visit during the Screening/Baseline period. Descriptive statistics were used to summarize the data. For total scores, waterfall plots, and histograms were created at the EOT visit with plots for all participants.||||0.0647
72394210|NCT05025241|144295065|OTHER|Change from baseline||||||0.0984|||||||Wilcoxon Signed rank|||Efficacy endpoints were analyzed using a Wilcoxon signed rank test on the paired participant data from baseline to EOT (Visit 16), when applicable. Baseline values were based on the average non-missing values of visits 1, 2, and 3 for assessments collected at more than one visit during the Screening/Baseline period. Descriptive statistics were used to summarize the data. For total scores, waterfall plots, and histograms were created at the EOT visit with plots for all participants||||0.0984
72394211|NCT05025241|144295066|OTHER|Change from baseline||||||0.0013|||||||Wilcoxon Signed rank|||Efficacy endpoints were analyzed using a Wilcoxon signed rank test on the paired participant data from baseline to EOT (Visit 16), when applicable. Baseline values were based on the average non-missing values of visits 1, 2, and 3 for assessments collected at more than one visit during the Screening/Baseline period. Descriptive statistics were used to summarize the data. For total scores, waterfall plots, and histograms were created at the EOT visit with plots for all participants||||0.0013
72394212|NCT05025241|144295067|OTHER|Change from baseline||||||0.0191|||||||Wilcoxon Signed rank|||Efficacy endpoints were analyzed using a Wilcoxon signed rank test on the paired participant data from baseline to EOT (Visit 16), when applicable. Baseline values were based on the average non-missing values of visits 1, 2, and 3 for assessments collected at more than one visit during the Screening/Baseline period. Descriptive statistics were used to summarize the data. For total scores, waterfall plots, and histograms were created at the EOT visit with plots for all participants||||0.0191
72394213|NCT05025241|144295068|OTHER|change from baseline||||||0.0013|||||||Wilcoxon Signed rank|||Efficacy endpoints were analyzed using a Wilcoxon signed rank test on the paired participant data from baseline to EOT (Visit 16), when applicable. Baseline values were based on the average non-missing values of visits 1, 2, and 3 for assessments collected at more than one visit during the Screening/Baseline period. Descriptive statistics were used to summarize the data. For total scores, waterfall plots, and histograms were created at the EOT visit with plots for all participants||||0.0013
72394214|NCT05025241|144295069|OTHER|change from baseline||||||0.171|||||||Wilcoxon Signed rank|||Efficacy endpoints were analyzed using a Wilcoxon signed rank test on the paired participant data from baseline to EOT (Visit 16), when applicable. Baseline values were based on the average non-missing values of visits 1, 2, and 3 for assessments collected at more than one visit during the Screening/Baseline period. Descriptive statistics were used to summarize the data. For total scores, waterfall plots, and histograms were created at the EOT visit with plots for all participants||||0.1710
72394215|NCT05025241|144295070|OTHER|change from baseline||||||0.0066|||||||Wilcoxon Signed rank|||Efficacy endpoints were analyzed using a Wilcoxon signed rank test on the paired participant data from baseline to EOT (Visit 16), when applicable. Baseline values were based on the average non-missing values of visits 1, 2, and 3 for assessments collected at more than one visit during the Screening/Baseline period. Descriptive statistics were used to summarize the data. For total scores, waterfall plots, and histograms were created at the EOT visit with plots for all participants||||0.0066
72394216|NCT05025241|144295071|OTHER|change form baseline||||||0.1094|||||||Wilcoxon Signed rank|||Efficacy endpoints were analyzed using a Wilcoxon signed rank test on the paired participant data from baseline to EOT (Visit 16), when applicable. Baseline values were based on the average non-missing values of visits 1, 2, and 3 for assessments collected at more than one visit during the Screening/Baseline period. Descriptive statistics were used to summarize the data. For total scores, waterfall plots, and histograms were created at the EOT visit with plots for all participants||||0.1094
72465704|NCT01393613|144454337|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3||||0.0422|TWO_SIDED|95.0|-0.6|-0.01|||Cochran-Mantel-Haenszel|CMH row mean scores differ test controlling for study center.||Statistical analysis to compare brexpiprazole 2mg/day and placebo was performed at Week 6.||-0.01|-0.60|0.0422
72465705|NCT01393613|144454337|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.24||||0.1358|TWO_SIDED|95.0|-0.56|0.08|||Cochran-Mantel-Haenszel|CMH row mean scores differ test controlling for study center.||Statistical analysis to compare brexpiprazole 1mg/day and placebo was performed at Week 6.||0.08|-0.56|0.1358
72564195|NCT02598895|144660165|OTHER|||||||||||||||||The primary efficacy endpoint was percent patients achieving PSA decline of 50% or more from baseline (PSA50), assessed in the time prior to disease progression, unacceptable toxicity or 1 year after the last study medication. The historical comparison was PSA50 of 26%. The target response rate was 60%. The study followed an optimal two-stage Simon design (Simon, 1989) where the null hypothesis that the true PSA response rate PSA50 was 0.26 was tested against a one-sided alternative.|See above|||
72564196|NCT00104247|144660166|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||||||<0.001
72394217|NCT05025241|144295072|OTHER|change from baseline||||||0.0156|||||||Wilcoxon Signed rank|||Efficacy endpoints were analyzed using a Wilcoxon signed rank test on the paired participant data from baseline to EOT (Visit 16), when applicable. Baseline values were based on the average non-missing values of visits 1, 2, and 3 for assessments collected at more than one visit during the Screening/Baseline period. Descriptive statistics were used to summarize the data. For total scores, waterfall plots, and histograms were created at the EOT visit with plots for all participants||||0.0156
72394218|NCT05025241|144295073|OTHER|change from baseline||||||0.0326|||||||Wilcoxon Signed rank|||Efficacy endpoints were analyzed using a Wilcoxon signed rank test on the paired participant data from baseline to EOT (Visit 16), when applicable. Baseline values were based on the average non-missing values of visits 1, 2, and 3 for assessments collected at more than one visit during the Screening/Baseline period. Descriptive statistics were used to summarize the data. For total scores, waterfall plots, and histograms were created at the EOT visit with plots for all participants||||0.0326
72465706|NCT01393613|144454338|SUPERIORITY_OR_OTHER||Relative Risk|1.54||||0.0006|TWO_SIDED|95.0|1.2|2.0|||Cochran-Mantel-Haenszel|CMH general association test||Statistical analysis to compare brexpiprazole 4mg/day and placebo was performed at Week 6.||2.00|1.20|0.0006
72465707|NCT01393613|144454338|SUPERIORITY_OR_OTHER||Relative Risk|1.22||||0.168|TWO_SIDED|95.0|0.92|1.62|||Cochran-Mantel-Haenszel|CMH general association test||Statistical analysis to compare brexpiprazole 2mg/day and placebo was performed at Week 6.||1.62|0.92|0.1680
72502856|NCT01193335|144536071|SUPERIORITY_OR_OTHER||Percent Difference|-5.9|||||TWO_SIDED|95.0|-23.6|11.8||||||Serotype 6B: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||11.8|-23.6|
72502857|NCT01193335|144536071|SUPERIORITY_OR_OTHER||Percent Difference|-10.7|||||TWO_SIDED|95.0|-27.6|6.0||||||Serotype 9V: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||6.0|-27.6|
72502858|NCT01193335|144536071|SUPERIORITY_OR_OTHER||Percent Difference|-4.3|||||TWO_SIDED|95.0|-17.0|8.4||||||Serotype 14: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||8.4|-17.0|
72502859|NCT01193335|144536071|SUPERIORITY_OR_OTHER||Percent Difference|-23.0|||||TWO_SIDED|95.0|-40.0|-4.9||||||Serotype 18C: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||-4.9|-40.0|
72502860|NCT01193335|144536071|SUPERIORITY_OR_OTHER||Percent Difference|-11.9|||||TWO_SIDED|95.0|-27.4|3.4||||||Serotype 19F: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||3.4|-27.4|
72502861|NCT01193335|144536071|SUPERIORITY_OR_OTHER||Percent Difference|-28.2|||||TWO_SIDED|95.0|-43.9|-11.0||||||Serotype 23F: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||-11.0|-43.9|
72502862|NCT01193335|144536071|SUPERIORITY_OR_OTHER||Percent Difference|-0.3|||||TWO_SIDED|95.0|-10.9|10.3||||||Serotype 1: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||10.3|-10.9|
72564197|NCT01886937|144660174|SUPERIORITY|||||||0.26|||||||t-test, 2 sided|||||||0.26
72564198|NCT01917968|144660181|SUPERIORITY||Adjusted difference in percentages|6.5||||0.056|TWO_SIDED|90.0|-0.2|13.2||Statistical significance is considered at 0.05 level.|Z statistics|P-value is calculated using a Z statistics from the propensity score adjusted estimates. Missing values are handled using multiple imputation.||||13.2|-0.2|0.056
72564199|NCT01917968|144660182|NON_INFERIORITY|With type I error of 0.05 and type II error of 0.20 (power 80%), 298 subjects (149 subjects per arm) are needed to detect non-inferiority with a margin of 10%.|Adjusted difference in percentages|-0.4|||||TWO_SIDED|90.0|-2.7|1.9|||||The propensity score adjusted difference in SAE rate of Uphold LITE transvaginal mesh (TVM) vs. NTR was estimated.|||1.9|-2.7|
72394219|NCT04294472|144295090|SUPERIORITY|Cohort 1 vs Placebo||||||0.1866|||||||Log Rank|||||||0.1866
72394220|NCT04294472|144295090|SUPERIORITY|Cohort 2 vs Placebo||||||0.2627|||||||Log Rank|||||||0.2627
72502863|NCT01193335|144536071|SUPERIORITY_OR_OTHER||Percent Difference|-1.2|||||TWO_SIDED|95.0|-17.5|15.1||||||Serotype 3: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||15.1|-17.5|
72502864|NCT01193335|144536071|SUPERIORITY_OR_OTHER||Percent Difference|-10.6|||||TWO_SIDED|95.0|-25.3|4.5||||||Serotype 5: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||4.5|-25.3|
72502865|NCT01193335|144536071|SUPERIORITY_OR_OTHER||Percent Difference|-18.6|||||TWO_SIDED|95.0|-33.3|-3.0||||||Serotype 6A: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||-3.0|-33.3|
72502866|NCT01193335|144536071|SUPERIORITY_OR_OTHER||Percent Difference|2.8|||||TWO_SIDED|95.0|-7.1|13.1||||||Serotype 7F: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||13.1|-7.1|
72465708|NCT01393613|144454338|SUPERIORITY_OR_OTHER||Relative Risk|1.35||||0.0433|TWO_SIDED|95.0|1.02|1.79|||Cochran-Mantel-Haenszel|CMH general association test||Statistical analysis to compare brexpiprazole 1mg/day and placebo was performed at Week 6.||1.79|1.02|0.0433
72502867|NCT01193335|144536071|SUPERIORITY_OR_OTHER||Percent Difference|-18.5|||||TWO_SIDED|95.0|-33.7|-2.8||||||Serotype 19A: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||-2.8|-33.7|
72502868|NCT01193335|144536072|SUPERIORITY_OR_OTHER||Percent Difference|-7.9|||||TWO_SIDED|95.0|-25.2|9.9||||||Serotype 4: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||9.9|-25.2|
72502869|NCT01193335|144536072|SUPERIORITY_OR_OTHER||Percent Difference|0.3|||||TWO_SIDED|95.0|-18.5|19.0||||||Serotype 6B: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||19.0|-18.5|
72502870|NCT01193335|144536072|SUPERIORITY_OR_OTHER||Percent Difference|7.3|||||TWO_SIDED|95.0|-12.0|26.2||||||Serotype 9V: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||26.2|-12.0|
72465709|NCT01393613|144454339|SUPERIORITY_OR_OTHER||Relative Risk|0.82||||0.5202|TWO_SIDED|95.0|0.44|1.51|||Cochran-Mantel-Haenszel|CMH general association test||Statistical analysis to compare brexpiprazole 4mg/day and placebo was performed at Week 6.||1.51|0.44|0.5202
72465710|NCT01393613|144454339|SUPERIORITY_OR_OTHER||Relative Risk|1.0||||0.9894|TWO_SIDED|95.0|0.55|1.85|||Cochran-Mantel-Haenszel|CMH general association test||Statistical analysis to compare brexpiprazole 2mg/day and placebo was performed at Week 6.||1.85|0.55|0.9894
72564200|NCT02148445|144660206|SUPERIORITY|Based on prior studies using precessation NRT, we estimate a 2-fold increase in cessation outcomes in the GMT group compared to the SC group. Given our recruitment of patients at all levels of readiness to quit, we estimate a 12 month cessation rate of 10%. With 199 participants, in each arm, we will have an 80% power to detect a 2-fold difference or greater with a Type I error rate of 5%.||||||0.88|||||||Chi-squared|||||||0.88
72564201|NCT02148445|144660207|SUPERIORITY|Based on prior studies using precessation NRT, we estimate a 2-fold increase in cessation outcomes in the GMT group compared to the SC group. Given our recruitment of patients at all levels of readiness to quit, we estimate a 12 month cessation rate of 10%. With 199 participants, in each arm, we will have an 80% power to detect a 2-fold difference or greater with a Type I error rate of 5%. This sample size will provide comparable power for looking at 6 month sustained cessation.||||||0.55|||||||Chi-squared|||||||0.55
72465711|NCT01393613|144454339|SUPERIORITY_OR_OTHER||Relative Risk|0.76||||0.4586|TWO_SIDED|95.0|0.36|1.59|||Cochran-Mantel-Haenszel|CMH general association test||Statistical analysis to compare brexpiprazole 1mg/day and placebo was performed at Week 6.||1.59|0.36|0.4586
72465712|NCT01393613|144454340|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.39||||0.0029|TWO_SIDED|95.0|-2.3|-0.48|||Mixed Models Analysis|MMRM analysis fixed effect of treatment, trial site, visit, treatment visit interaction, Baseline value, Baseline visit interaction as covariates.||Statistical analysis to compare brexpiprazole 4mg/day and placebo was performed at Week 6.||-0.48|-2.30|0.0029
72465713|NCT01393613|144454340|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.43||||0.3559|TWO_SIDED|95.0|-1.34|0.48|||Mixed Models Analysis|MMRM analysis fixed effect of treatment, trial site, visit, treatment visit interaction, Baseline value, Baseline visit interaction as covariates.||Statistical analysis to compare brexpiprazole 2mg/day and placebo was performed at Week 6.||0.48|-1.34|0.3559
72465714|NCT01393613|144454340|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.48||||0.3646|TWO_SIDED|95.0|-1.51|0.56|||Mixed Models Analysis|MMRM analysis fixed effect of treatment, trial site, visit, treatment visit interaction, Baseline value, Baseline visit interaction as covariates.||Statistical analysis to compare brexpiprazole 1mg/day and placebo was performed at Week 6.||0.56|-1.51|0.3646
72465715|NCT01393613|144454341|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.14||||0.1273|TWO_SIDED|95.0|-2.61|0.33|||Mixed Models Analysis|MMRM analysis fixed effect of treatment, trial site, visit, treatment visit interaction, Baseline value, Baseline visit interaction as covariates.||Statistical analysis to compare brexpiprazole 4mg/day and placebo was performed at Week 6.||0.33|-2.61|0.1273
72465716|NCT01393613|144454341|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.35||||0.64|TWO_SIDED|95.0|-1.83|1.12|||Mixed Models Analysis|MMRM analysis fixed effect of treatment, trial site, visit, treatment visit interaction, Baseline value, Baseline visit interaction as covariates.||Statistical analysis to compare brexpiprazole 2mg/day and placebo was performed at Week 6.||1.12|-1.83|0.6400
72465717|NCT01393613|144454341|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.65||||0.4423|TWO_SIDED|95.0|-2.32|1.01|||Mixed Models Analysis|MMRM analysis fixed effect of treatment, trial site, visit, treatment visit interaction, Baseline value, Baseline visit interaction as covariates.||Statistical analysis to compare brexpiprazole 1mg/day and placebo was performed at Week 6.||1.01|-2.32|0.4423
72564202|NCT02148445|144660208|SUPERIORITY|||||||0.4|||||||Mixed Models Analysis|||||||0.40
72564203|NCT02148445|144660209|SUPERIORITY|||||||0.05|||||||Mixed Models Analysis|||||||0.05
72394221|NCT04294472|144295091|SUPERIORITY|Cohort 1 vs Placebo||||||0.0639|||||||Log Rank|||||||0.0639
72394222|NCT04294472|144295091|SUPERIORITY|Cohort 2 vs Placebo||||||0.0508|||||||Log Rank|||||||0.0508
72465718|NCT01393613|144454342|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.28||||0.0194|TWO_SIDED|95.0|-2.36|-0.21|||Mixed Models Analysis|MMRM analysis fixed effect of treatment, trial site, visit, treatment visit interaction, Baseline value, Baseline visit interaction as covariates.||Statistical analysis to compare brexpiprazole 4mg/day and placebo was performed at Week 6.||-0.21|-2.36|0.0194
72465719|NCT01393613|144454342|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.98||||0.0754|TWO_SIDED|95.0|-2.06|0.1|||Mixed Models Analysis|MMRM analysis fixed effect of treatment, trial site, visit, treatment visit interaction, Baseline value, Baseline visit interaction as covariates.||Statistical analysis to compare brexpiprazole 2mg/day and placebo was performed at Week 6.||0.10|-2.06|0.0754
72564204|NCT02148445|144660210|SUPERIORITY|||||||0.05|||||||Mixed Models Analysis|||||||0.05
72394223|NCT01482884|144295167|SUPERIORITY_OR_OTHER||Risk Difference (RD)|4.8||||0.4062|TWO_SIDED|95.0|-13.0|22.5||Glucocorticosteroid-refractory status as stratification factor|Cochran-Mantel-Haenszel|||The null hypothesis is that the proportion of participants responding on tralokinumab is less than or equal to the proportion of participants responding on placebo.||22.5|-13.0|0.4062
72394224|NCT01482884|144295168|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.49|STANDARD_ERROR_OF_MEAN|0.57||0.3937|TWO_SIDED|95.0|-1.63|0.65|||ANCOVA|Mayo score at baseline as a covariate, and treatment and glucocorticosteroid-refractory status as factors in the model.||||0.65|-1.63|0.3937
72394225|NCT01482884|144295169|SUPERIORITY_OR_OTHER||Risk Difference (RD)|12.1||||0.1043|TWO_SIDED|95.0|-4.0|28.3||Glucocorticosteroid-refractory status as stratification factor|Cochran-Mantel-Haenszel|||||28.3|-4.0|0.1043
72394226|NCT01482884|144295170|SUPERIORITY_OR_OTHER||Risk Difference (RD)|12.4||||0.0326|TWO_SIDED|95.0|0.7|24.1||Glucocorticosteroid-refractory status as stratification factor|Cochran-Mantel-Haenszel|||||24.1|0.7|0.0326
72394227|NCT01482884|144295172|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.25|STANDARD_ERROR_OF_MEAN|0.33||0.449|TWO_SIDED|95.0|-0.41|0.91|||ANCOVA|Modified Riley score at baseline as a covariate, and treatment as factors in the model.||||0.91|-0.41|0.4490
72394228|NCT00580606|144295178|SUPERIORITY_OR_OTHER||Risk Difference (RD)|55.0|||<|0.001|TWO_SIDED|95.0|22.2|77.6||No adjustments were made to the p-value.|Barnard's Statistic|The a priori threshold for statistical significance is 0.05.||Number of participants who successfully consumed 5,000 mg of peanut powder or at least a 10-fold increase in the amount of peanut powder compared to their baseline OFC was compared using Barnard's Statistic with the null hypothesis that there was no difference between treatment groups.||77.6|22.2|<0.001
72394229|NCT05353985|144295195|SUPERIORITY||LS Mean Difference|0.017|||=|0.847|TWO_SIDED|95.0|-0.162|0.197||P-value was based on a MMRM analysis with treatment group, week, treatment-by-week interaction, \& the randomization stratification factors as fixed effects \& baseline CDSD GI symptom severity scores as covariates, and participant as a random effect.|MMRM|||||0.197|-0.162|=0.847
72394230|NCT05353985|144295196|SUPERIORITY||LS Mean Difference|-0.331|||<|0.001|TWO_SIDED|95.0|-0.481|-0.181||P-value was based on a ANCOVA model with treatment group and randomization stratification factors as fixed effects and baseline Vh:Cd as covariates.|ANCOVA|||||-0.181|-0.481|<0.001
72394231|NCT04493281|144295203|EQUIVALENCE|The analysis was performed by analysis of variance (ANOVA), which included factors accounting for the following sources of variation: sequence, subjects nested in sequences, period, and treatment. For bioequivalence, the 90% CIs of the geometric mean ratio of AUC0-t for oral suspension and intravenous formulation were required to be within the range of 0.80 to 1.25.|Ratio (PO/IV)|0.97|||||TWO_SIDED|90.0|0.91|1.04||||||||1.04|0.91|
72465720|NCT01393613|144454342|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0||||0.108|TWO_SIDED|95.0|-2.22|0.22|||Mixed Models Analysis|MMRM analysis fixed effect of treatment, trial site, visit, treatment visit interaction, Baseline value, Baseline visit interaction as covariates.||Statistical analysis to compare brexpiprazole 1mg/day and placebo was performed at Week 6.||0.22|-2.22|0.1080
72465721|NCT01393613|144454343|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.39||||0.0045|TWO_SIDED|95.0|-2.34|-0.43|||Mixed Models Analysis|MMRM analysis fixed effect of treatment, trial site, visit, treatment visit interaction, Baseline value, Baseline visit interaction as covariates.||Statistical analysis to compare brexpiprazole 4mg/day and placebo was performed at Week 6. Because only the comparison of brexpiprazole 4 mg/day versus placebo met the threshold in the primary analysis, the following analysis is not part for the formal statistical testing and is descriptive only.||-0.43|-2.34|0.0045
72465722|NCT01393613|144454343|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.35||||0.4753|TWO_SIDED|95.0|-1.31|0.61|||Mixed Models Analysis|MMRM analysis fixed effect of treatment, trial site, visit, treatment visit interaction, Baseline value, Baseline visit interaction as covariates.||Statistical analysis to compare brexpiprazole 2mg/day and placebo was performed at Week 6.||0.61|-1.31|0.4753
72465723|NCT01393613|144454343|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.87||||0.115|TWO_SIDED|95.0|-1.96|0.21|||Mixed Models Analysis|MMRM analysis fixed effect of treatment, trial site, visit, treatment visit interaction, Baseline value, Baseline visit interaction as covariates.||Statistical analysis to compare brexpiprazole 1mg/day and placebo was performed at Week 6.||0.21|-1.96|0.1150
72621348|NCT02732145|144773192|SUPERIORITY|Question: Is there a difference in the incidence of specific lesion of Labia Minora versus specific lesions of the Posterior Commissure in patients with vulvar dermatosis?||||||0.8848|||||||t-test proportion|||Parameter: The difference in the incidence of specific lesions of Labia Minora versus specific lesions of the Posterior Commissure in patients with vulvar dermatosis.||||0.8848
72394232|NCT04493281|144295204|EQUIVALENCE|The analysis was performed by analysis of variance (ANOVA), which included factors accounting for the following sources of variation: sequence, subjects nested in sequences, period, and treatment. For bioequivalence, the 90% CIs of the geometric mean ratio of AUC0-inf for oral suspension and intravenous formulation were required to be within the range of 0.80 to 1.25.|Ratio (PO/IV)|0.98|||||TWO_SIDED|90.0|0.92|1.04||||||||1.04|0.92|
72394233|NCT04493281|144295205|EQUIVALENCE|The analysis was performed by analysis of variance (ANOVA), which included factors accounting for the following sources of variation: sequence, subjects nested in sequences, period, and treatment. For bioequivalence, the 90% CIs of the geometric mean ratio of Cmax for oral suspension and intravenous formulation were required to be within the range of 0.80 to 1.25.|Ratio (PO/IV)|1.22|||||TWO_SIDED|90.0|1.09|1.36||||||||1.36|1.09|
72394234|NCT02692703|144295268|NON_INFERIORITY|The noninferiority of the rate of sustained virologic response at 12 weeks after treatment as compared with the historical rate for the current standard of care regimens (SOF/LDV + RBV or SOF + DCV + RBV) was analyzed; the lower confidence bound of the 2-sided 95% confidence interval (95% CI) for the percentage of participants with sustained virologic response at 12 weeks after treatment must exceed 86% to achieve noninferiority.|Percentage of Participants|98.0|||||TWO_SIDED|95.0|95.3|100.0||||||Based on a 2-sided significance level of 0.05 and an underlying rate of ≥96%, 90 participants provides \>90% power to demonstrate noninferiority of the regimen to the historical rate for current standard of care regimens (SOF/LDV + RBV OR SOF + DCV + RBV) (94%) (based on the normal approximation of a single binomial proportion in a one-sample test for superiority).||100.0|95.3|
72564205|NCT02148445|144660211|SUPERIORITY|||||||0.39|||||||Mixed Models Analysis|||||||0.39
72564206|NCT02148445|144660212|SUPERIORITY|||||||0.42|||||||t-test, 1 sided|||||||0.42
72564207|NCT02148445|144660213|SUPERIORITY|||||||0.27|||||||Mixed Models Analysis|||||||0.27
72564208|NCT02148445|144660214|SUPERIORITY|||||||0.06|||||||Mixed Models Analysis|||||||0.06
72564209|NCT02148445|144660216|SUPERIORITY|||||||0.08|||||||Chi-squared|||Month 3 self-reported abstinence||||0.08
72564210|NCT02148445|144660216|SUPERIORITY|||||||0.06|||||||Chi-squared|||Month 3 biochemically verified abstinence||||0.06
72564211|NCT02148445|144660216|SUPERIORITY|||||||0.22|||||||Chi-squared|||Month 6, self-reported abstinence||||0.22
72564212|NCT02148445|144660216|SUPERIORITY|||||||0.34|||||||Chi-squared|||Month 6, biochemically verified abstinence||||0.34
72621349|NCT02732145|144773193|EQUIVALENCE|Question: Is there a difference in the incidence of non-specific lesions of the Clitoris among patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of non-specific lesions of the Clitoris in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant for the diagnosis of the vulvodynia."||||0.0000
72621350|NCT02732145|144773193|EQUIVALENCE|Question: Is there a difference in the incidence of non-specific lesions of Hart's Line among patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of non-specific lesions of Hart's Line in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant for the diagnosis of the vulvodynia."||||0.0000
72621351|NCT02732145|144773193|EQUIVALENCE|Question: Is there a difference in the incidence of non-specific lesions of the Urethral Sulcus among patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of non-specific lesions of the Urethral Sulcus in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of the vulvodynia."||||0.0000
72621352|NCT02732145|144773193|EQUIVALENCE|Question: Is there a difference in the incidence of non-specific lesions of the Urethral Meatus among patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of non-specific lesions of the Urethral meatus in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of the vulvodynia."||||0.0000
72621353|NCT02732145|144773193|EQUIVALENCE|Question: Is there a difference in the incidence of non-specific lesions of Hymenal Remnants among patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of non-specific lesions of Hymenal Remnants in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of the vulvodynia."||||0.0000
72621354|NCT02732145|144773193|EQUIVALENCE|Question: Is there a difference in the incidence of non-specific lesions of Bartholin's Gland Opening among the patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of non-specific lesions of Bartholin's Gland Opening in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of the vulvodynia."||||0.0000
72621355|NCT02732145|144773193|EQUIVALENCE|Question: Is there a difference in the incidence of non-specific lesions of the Vestibule among patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of non-specific lesions of the Vestibule in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of the vulvodynia."||||0.0000
72621356|NCT02732145|144773193|EQUIVALENCE|Question: Is there a difference in the incidence of erythema of the Clitoris among patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of erythema of the Clitoris in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of the vulvodynia."||||0.0000
72370623|NCT00488683|144251634|SUPERIORITY_OR_OTHER||R-square|0.01||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and hSBA titers one week after booster vaccination for the serogroup A||||
72564213|NCT02148445|144660216|SUPERIORITY|||||||0.66|||||||Chi-squared|||Month 12, self-reported abstinence||||0.66
72564214|NCT02148445|144660217|SUPERIORITY|||||||0.0149|||||||Mixed Models Analysis|||||||0.0149
72564215|NCT02148445|144660218|SUPERIORITY|||||||0.05|||||||Mixed Models Analysis|||||||0.05
72564216|NCT02148445|144660219|SUPERIORITY|||||||0.08|||||||Mixed Models Analysis|||||||0.08
72564217|NCT02148445|144660220|SUPERIORITY|||||||0.77|||||||Mixed Models Analysis|||||||0.77
72564218|NCT02148445|144660221|SUPERIORITY|||||||0.0918|||||||Mixed Models Analysis|||||||0.0918
72564219|NCT03450629|144660222|EQUIVALENCE|8 AM +/- 30 min||||||0.0006|||||||t-test, 2 sided|||||||0.0006
72564220|NCT03450629|144660222|EQUIVALENCE|10 AM +/- 30 min||||||0.0291|||||||t-test, 2 sided|||||||0.0291
72564221|NCT03450629|144660222|EQUIVALENCE|4 PM +/- 30 min||||||0.0002|||||||t-test, 2 sided|||||||0.0002
72564222|NCT04230876|144660223|SUPERIORITY||partial eta squared|0.047|||=|0.269|TWO_SIDED|||||Within the 28 participants, changes in the COSI scores after four weeks using the Amptify were compared to the changes after four weeks watching 20 minutes of CC TV (F(1,26)=1.28).|ANOVA|||||||=0.269
72564223|NCT04230876|144660224|SUPERIORITY||partial eta squared|0.031|||=|0.401|TWO_SIDED|||||Changes in the IOI-HA scores measured after four weeks using the Amptify were compared to the changes seen after four weeks of CC TV every day (F(1,23)=.733).|ANOVA|||||||=0.401
72394235|NCT02509156|144295386|SUPERIORITY||Mean Difference (Final Values)|0.8|STANDARD_ERROR_OF_MEAN|2.57||0.746|TWO_SIDED|95.0|-4.52|6.11|||ANCOVA|The change in LVEF was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t-test|||6.11|-4.52|0.746
72394236|NCT02509156|144295387|SUPERIORITY||slope of time|1.53|STANDARD_ERROR_OF_MEAN|0.63||0.024|TWO_SIDED|||||No adjustments for multiplicity were made in this Phase I trial|Repeated Measures Linear Regression||"Standard error of the mean is the standard error of the estimate of the slope of time."|Repeated-measures linear regression models were used to address trajectories (upward or downward trends) over time within each of the treatment groups. If there was no significant interaction, only one trajectory (slope) was reported.||||0.024
72465724|NCT01393613|144454344|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.26||||0.0021|TWO_SIDED|95.0|-2.05|-0.46|||Mixed Models Analysis|MMRM analysis fixed effect of treatment, trial site, visit, treatment visit interaction, Baseline value, Baseline visit interaction as covariates.||Statistical analysis to compare brexpiprazole 4mg/day and placebo was performed at Week 6.||-0.46|-2.05|0.0021
72465725|NCT01393613|144454344|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.17||||0.6792|TWO_SIDED|95.0|-0.97|0.63|||Mixed Models Analysis|MMRM analysis fixed effect of treatment, trial site, visit, treatment visit interaction, Baseline value, Baseline visit interaction as covariates.||Statistical analysis to compare brexpiprazole 2mg/day and placebo was performed at Week 6.||0.63|-0.97|0.6792
72465726|NCT01393613|144454344|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.26||||0.5752|TWO_SIDED|95.0|-1.16|0.65|||Mixed Models Analysis|MMRM analysis fixed effect of treatment, trial site, visit, treatment visit interaction, Baseline value, Baseline visit interaction as covariates.||Statistical analysis to compare brexpiprazole 1mg/day and placebo was performed at Week 6.||0.65|-1.16|0.5752
72502871|NCT01193335|144536072|SUPERIORITY_OR_OTHER||Percent Difference|-2.8|||||TWO_SIDED|95.0|-19.1|13.3||||||Serotype 14: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||13.3|-19.1|
72502872|NCT01193335|144536072|SUPERIORITY_OR_OTHER||Percent Difference|-17.9|||||TWO_SIDED|95.0|-34.6|-0.3||||||Serotype 18C: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||-0.3|-34.6|
72465727|NCT01393613|144454345|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.86||||0.0104|TWO_SIDED|95.0|-1.51|-0.2|||Mixed Models Analysis|MMRM analysis fixed effect of treatment, trial site, visit, treatment visit interaction, Baseline value, Baseline visit interaction as covariates.||Statistical analysis to compare brexpiprazole 4mg/day and placebo was performed at Week 6.||-0.20|-1.51|0.0104
72465728|NCT01393613|144454345|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7||||0.0373|TWO_SIDED|95.0|-1.35|-0.04|||Mixed Models Analysis|MMRM analysis fixed effect of treatment, trial site, visit, treatment visit interaction, Baseline value, Baseline visit interaction as covariates.||Statistical analysis to compare brexpiprazole 2mg/day and placebo was performed at Week 6.||-0.04|-1.35|0.0373
72465729|NCT01393613|144454345|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.64||||0.089|TWO_SIDED|95.0|-1.39|0.1|||Mixed Models Analysis|MMRM analysis fixed effect of treatment, trial site, visit, treatment visit interaction, Baseline value, Baseline visit interaction as covariates.||Statistical analysis to compare brexpiprazole 1mg/day and placebo was performed at Week 6.||0.10|-1.39|0.0890
72465730|NCT02598934|144454421|SUPERIORITY_OR_OTHER||Difference in percentage of participants|16.9||||0.002|TWO_SIDED|95.0|6.1|27.7||P-value between Consult group and Non-consult group for the item in the BCS: ibandronate was effective in treating osteoporosis|Chi-squared, Corrected|||||27.7|6.1|0.002
72502873|NCT01193335|144536072|SUPERIORITY_OR_OTHER||Percent Difference|-4.3|||||TWO_SIDED|95.0|-20.6|12.1||||||Serotype 19F: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||12.1|-20.6|
72502874|NCT01193335|144536072|SUPERIORITY_OR_OTHER||Percent Difference|-21.1|||||TWO_SIDED|95.0|-37.8|-3.2||||||Serotype 23F: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||-3.2|-37.8|
72502875|NCT01193335|144536072|SUPERIORITY_OR_OTHER||Percent Difference|5.6|||||TWO_SIDED|95.0|-2.7|15.2||||||Serotype 1: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||15.2|-2.7|
72502876|NCT01193335|144536072|SUPERIORITY_OR_OTHER||Percent Difference|-5.1|||||TWO_SIDED|95.0|-22.0|12.0||||||Serotype 3: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||12.0|-22.0|
72564224|NCT04230876|144660225|SUPERIORITY||partial eta squared|0.0|||=|0.968|TWO_SIDED|||||Changes in the APHAB benefit scores after four weeks using the Amptify were compared to the improvements seen after four weeks of CC TV every day (F(1,25)=.002).|ANOVA|||||||=0.968
72564225|NCT04230876|144660226|SUPERIORITY||partial eta squared|0.028|||=|0.392|TWO_SIDED|||||Changes in the SSQ-12 scores after four weeks using the Amptify were compared to the improvements seen after four weeks watching 20 minutes of CC TV (F(1,26)=.756).|ANOVA|||||||=0.392
72394237|NCT02509156|144295388|SUPERIORITY||Mean Difference (Final Values)|-0.71|STANDARD_ERROR_OF_MEAN|0.94||0.328|TWO_SIDED|95.0|-2.68|1.26|||ANCOVA||Confidence intervals based on t-test|The change in global strain was compared using ANCOVA analyses adjusting for baseline values.||1.26|-2.68|0.328
72502877|NCT01193335|144536072|SUPERIORITY_OR_OTHER||Percent Difference|-14.4|||||TWO_SIDED|95.0|-26.7|-2.4||||||Serotype 5: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||-2.4|-26.7|
72502878|NCT01193335|144536072|SUPERIORITY_OR_OTHER||Percent Difference|-20.4|||||TWO_SIDED|95.0|-36.8|-3.0||||||Serotype 6A: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||-3.0|-36.8|
72502879|NCT01193335|144536072|SUPERIORITY_OR_OTHER||Percent Difference|-11.3|||||TWO_SIDED|95.0|-26.4|4.1||||||Serotype 7F: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||4.1|-26.4|
72502880|NCT01193335|144536072|SUPERIORITY_OR_OTHER||Percent difference|-21.6|||||TWO_SIDED|95.0|-37.7|-4.6||||||Serotype 19A: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||-4.6|-37.7|
72502881|NCT01733329|144536076|SUPERIORITY_OR_OTHER||||||<|0.01|||||||Fisher Exact|||||||<0.01
72502882|NCT01733329|144536077|SUPERIORITY_OR_OTHER|||||||0.026|||||||Fisher Exact|||||||0.026
72621357|NCT02732145|144773193|EQUIVALENCE|Question: Is there a difference in the incidence of erythema of Hart's Line among patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of erythema of Hart's Line in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of the vulvodynia."||||0.0000
72621358|NCT02732145|144773193|EQUIVALENCE|Question: Is there a difference in the incidence of erythema of the Urethral Sulcus among patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of erythema of the Urethral Sulcus in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of the vulvodynia."||||0.0000
72621359|NCT02732145|144773193|EQUIVALENCE|Question: Is there a difference in the incidence of erythema of the Urethral Meatus among patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of erythema of the Urethral Meatus in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of the vulvodynia."||||0.0000
72621360|NCT02732145|144773193|EQUIVALENCE|Question: Is there a difference in the incidence of erythema of Hymenal Remnants among patients from different groups?||||||0.0001|||||||Chi-squared|||"Parameter: The incidence of erythema of Hymenal Remnants in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of the vulvodynia."||||0.0001
72621361|NCT02732145|144773193|EQUIVALENCE|Question: Is there a difference in the incidence of erythema of Bartholin's Gland Opening among patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of erythema of Bartholin's Gland Opening in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of the vulvodynia."||||0.0000
72621362|NCT02732145|144773193|EQUIVALENCE|Question: Is there a difference in the incidence of erythema of the Vestibule among patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of erythema of the Vestibule in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of the vulvodynia."||||0.0000
72621363|NCT02732145|144773193|EQUIVALENCE|Question: Is there a difference in the incidence of smoothness of the Clitoris among patients from different groups?||||||0.0023|||||||Chi-squared|||"Parameter: The incidence of smoothness of the Clitoris in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of the vulvodynia."||||0.0023
72621364|NCT02732145|144773193|EQUIVALENCE|Question: Is there a difference in the incidence of smoothness of the Urethral Sulcus among patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of smoothness of the Urethral Sulcus in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of the vulvodynia."||||0.0000
72621365|NCT02732145|144773193|EQUIVALENCE|Question: Is there a difference in the incidence of smoothness of the Urethral Meatus among patients from different groups?||||||0.0235|||||||Chi-squared|||"Parameter: The incidence of smoothness of Urethral Meatus in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of the vulvodynia."||||0.0235
72621366|NCT02732145|144773193|EQUIVALENCE|Question: Is there a difference in the incidence of ischemia of the Clitoris among patients from different groups?||||||0.0021|||||||Chi-squared|||"Parameter: The incidence of ischemia of the Clitoris in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of the vulvodynia."||||0.0021
72621367|NCT02732145|144773193|EQUIVALENCE|Question: Is there a difference in the incidence of ischemia of the Urethral Sulcus among patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of ischemia of the Urethral Sulcus in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of the vulvodynia."||||0.0000
72621368|NCT02732145|144773193|EQUIVALENCE|Question: Is there a difference in the incidence of ischemia of the Urethral Meatus among patients from different groups?||||||0.0038|||||||Chi-squared|||"Parameter: The incidence of ischemia of the Urethral Meatus in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of the vulvodynia."||||0.0038
72621369|NCT02732145|144773193|EQUIVALENCE|Question: Is there a difference in the incidence of ischemia of the Vestibule among patients from different groups?||||||0.0019|||||||Chi-squared|||"Parameter: The incidence of ischemia of the Vestibule in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of the vulvodynia."||||0.0019
72621370|NCT02732145|144773193|EQUIVALENCE|Question: Is there a difference in the incidence of punctuation of Hart's Line among patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of punctuation of Hart's Line in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of the vulvodynia."||||0.0000
72394238|NCT02509156|144295389|SUPERIORITY||slope of time|-0.26|STANDARD_ERROR_OF_MEAN|0.23||0.261|TWO_SIDED|||||No adjustments for multiplicity were made in this Phase I trial.|Repeated Measures Linear Regression||"Standard error of the mean is the standard error of the estimate over time of the slope"|Repeated-measures linear regression models were used to address trajectories (upward or downward trends) over time within each of the treatment groups. If there was no significant interaction, only one trajectory (slope) was reported.||||0.261
72394239|NCT02509156|144295390|SUPERIORITY||Mean Difference (Final Values)|-1.58|STANDARD_ERROR_OF_MEAN|1.41||0.071|TWO_SIDED|95.0|-4.51|1.35|||ANCOVA||Confidence intervals based on t-test|The change in regional strain was compared using ANCOVA analyses adjusting for baseline values.||1.35|-4.51|0.071
72394240|NCT02509156|144295391|SUPERIORITY||slope of time|-0.14|STANDARD_ERROR_OF_MEAN|0.35||0.689|TWO_SIDED|||||No adjustments for multiplicity were made in this Phase I trial.|Repeated Measures Linear Regression||"Standard error of the mean is the standard error of the estimate over time of the slope"|Repeated-measures linear regression models were used to address trajectories (upward or downward trends) over time within each of the treatment groups. If there was no significant interaction, only one trajectory (slope) was reported.||||0.689
72394241|NCT02509156|144295392|SUPERIORITY||Mean Difference (Final Values)|1.06|STANDARD_ERROR_OF_MEAN|6.46||0.935|TWO_SIDED|95.0|-12.33|14.45|||ANCOVA||Confidence intervals based on t-test|The change in LVEDVI was compared using ANCOVA analyses adjusting for baseline values.||14.45|-12.33|0.935
72394242|NCT02509156|144295393|SUPERIORITY||slope of time|-1.56|STANDARD_ERROR_OF_MEAN|1.55||0.325|TWO_SIDED|||||No adjustments for multiplicity were made in this Phase I trial.|Repeated Measures Linear Regression||"Standard error of the mean is the standard error of the estimate over time of the slope"|Repeated-measures linear regression models were used to address trajectories (upward or downward trends) over time within each of the treatment groups. If there was no significant interaction, only one trajectory (slope) was reported.||||0.325
72394243|NCT02509156|144295394|SUPERIORITY||Mean Difference (Final Values)|0.66|STANDARD_ERROR_OF_MEAN|5.99||0.919|TWO_SIDED|95.0|-11.75|13.08|||ANCOVA||Confidence intervals based on t-test|The change in LVESVI was compared using ANCOVA analyses adjusting for baseline values.||13.08|-11.75|0.919
72394244|NCT02509156|144295395|SUPERIORITY||slope of time|-1.99|STANDARD_ERROR_OF_MEAN|1.45||0.183|TWO_SIDED|||||No adjustments for multiplicity were made in this Phase I trial.|Repeated Measures Linear Regression||"Standard error of the mean is the standard error of the estimate over time of the slope."|Repeated-measures linear regression models were used to address trajectories (upward or downward trends) over time within each of the treatment groups. If there was no significant interaction, only one trajectory (slope) was reported.||||0.183
72394245|NCT02509156|144295396|SUPERIORITY||Mean Difference (Final Values)|0.077|STANDARD_ERROR_OF_MEAN|0.035||0.124|TWO_SIDED|95.0|0.003|0.15|||ANCOVA||Confidence intervals based on t-test|The change in LV sphericity index was compared using ANCOVA analyses adjusting for baseline values.||0.15|0.003|0.124
72394246|NCT02509156|144295397|SUPERIORITY|||||||||||||||||Repeated-measures linear regression models were used to address trajectories (upward or downward trends) over time within each of the treatment groups. A time by treatment interaction was assessed.|There was a significant treatment and time interaction (p=0.024), so we report a slope for each treatment arm.|||
72394247|NCT02509156|144295398|SUPERIORITY||Mean Difference (Final Values)|-0.66|STANDARD_ERROR_OF_MEAN|1.14||0.993|TWO_SIDED|95.0|-3.05|1.74|||ANCOVA||Confidence intervals based on t-test|The change in scar percent was compared using ANCOVA analyses adjusting for baseline values.||1.74|-3.05|0.993
72394248|NCT02509156|144295399|SUPERIORITY||slope of time|-0.44|STANDARD_ERROR_OF_MEAN|0.29||0.151|TWO_SIDED|||||No adjustments for multiplicity were made in this Phase I trial.|Repeated Measures Linear Regression||"Standard error of the mean is the standard error of the estimate over time of the slope"|Repeated-measures linear regression models were used to address trajectories (upward or downward trends) over time within each of the treatment groups. If there was no significant interaction, only one trajectory (slope) was reported.||||0.151
72394249|NCT02509156|144295400|SUPERIORITY||Mean Difference (Final Values)|38.03|STANDARD_ERROR_OF_MEAN|20.96||0.056|TWO_SIDED|95.0|-5.84|81.89|||ANCOVA||Confidence intervals based on t-test|The change in distance walked was compared using ANCOVA analyses adjusting for baseline values.||81.89|-5.84|0.056
72465731|NCT02598934|144454421|SUPERIORITY_OR_OTHER||Difference in percentage of participants|14.9||||0.009|TWO_SIDED|95.0|4.0|25.8||P-value between Consult group and Non-consult group for the item in the BCS: ibandronate reduces risk of breaking bone.|Chi-squared, Corrected|||||25.8|4.0|0.009
72465732|NCT02598934|144454421|SUPERIORITY_OR_OTHER||Difference in percentage of participants|16.9||||0.001|TWO_SIDED|95.0|6.3|27.5|||Chi-squared, Corrected|P-value between Consult group and Non-consult group for items in BCS: ibandronate effective in treating osteoporosis or reduces risk of breaking bone.||||27.5|6.3|0.001
72465733|NCT02598934|144454421|SUPERIORITY_OR_OTHER||Difference in percentage of participants|14.9||||0.01|TWO_SIDED|95.0|3.9|25.9||P-value between Consult group and Non-consult group for items in BCS: ibandronate effective in treating osteoporosis and reduces risk of breaking bone.|Chi-squared, Corrected|||||25.9|3.9|0.010
72394250|NCT02509156|144295401|SUPERIORITY||slope of time|2.82|STANDARD_ERROR_OF_MEAN|5.06||0.583|TWO_SIDED|||||No adjustments for multiplicity were made in this Phase I trial.|Repeated Measures Linear Regression||"Standard error of the mean is the standard error of the estimate over time of the slope"|Repeated-measures linear regression models were used to address trajectories (upward or downward trends) over time within each of the treatment groups. If there was no significant interaction, only one trajectory (slope) was reported.||||0.583
72394251|NCT02509156|144295402|SUPERIORITY||Mean Difference (Final Values)|-12.82|STANDARD_ERROR_OF_MEAN|8.37||0.048|TWO_SIDED|95.0|-30.49|4.84|||ANCOVA||Confidence intervals based on t-test|The change in MLHFQ summary score was compared using ANCOVA analyses adjusting for baseline values.||4.84|-30.49|0.048
72502883|NCT01733329|144536078|SUPERIORITY_OR_OTHER|||||||0.058|||||||Fisher Exact|||||||0.058
72502884|NCT01733329|144536079|SUPERIORITY_OR_OTHER|||||||0.007|||||||Kruskal-Wallis|||||||0.007
72621371|NCT02732145|144773193|EQUIVALENCE|Question: Is there a difference in the incidence of punctuation of the Vestibule among patients from different groups?||||||0.0198|||||||Chi-squared|||"Parameter: The incidence of punctuation of the Vestibule in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy.. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of the vulvodynia."||||0.0198
72502885|NCT04246047|144536097|SUPERIORITY||Hazard Ratio (HR)|0.41|||<|1e-05||95.0|0.31|0.53|||one-sided stratified log-rank||Hazard ratio was estimated using a Cox Proportional Hazards model stratified by the number of lines of prior therapy, prior bortezomib and revised international staging system (R-ISS) at screening, with a covariate of treatment.|||0.53|0.31|<0.00001
72502886|NCT05139030|144536144|SUPERIORITY|A one-sided hypothesis test was performed at alpha=0.025 level of significance comparing EXPAREL admix and bupivacaine HCI|Mean Difference (Final Values)|-65.8|STANDARD_ERROR_OF_MEAN|26.97||0.0074|TWO_SIDED|95.0|-118.7|-12.9|||ANCOVA|Main effect of treatment, categorical covariate of pooled Investigator site, and continuous covariates of age||The superiority of EXPAREL admixed to bupivacaine HCI was evaluated using the Efficacy Analysis Set.||-12.9|-118.7|0.0074
72621372|NCT02732145|144773193|EQUIVALENCE|Question: Is there a difference in the incidence of papillae of Hart's Line among patients from different groups?||||||0.0004|||||||Chi-squared|||"Parameter: The incidence of papillae of Hart's Line in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of the vulvodynia."||||0.0004
72621373|NCT02732145|144773193|EQUIVALENCE|Question: Is there a difference in the incidence of papillae of the Vestibule among patients from different groups?||||||0.0053|||||||Chi-squared|||"Parameter: The incidence of papillae of the Vestibule in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of the vulvodynia."||||0.0053
72621374|NCT02732145|144773193|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of the Clitoris versus non-specific lesions of Hart's Line in patients with vulvar dermatosis?||||||0.001|||||||t-test proportion|||Parameter: The difference in the incidence of non-specific lesions of the Clitoris versus non-specific lesions of Hart's Line in patients with vulvar dermatosis.||||0.0010
72621375|NCT02732145|144773193|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of the Clitoris versus non-specific lesions of the Urethral Sulcus in patients with vulvar dermatosis?||||||0.001|||||||t-test proportion|||Parameter: The difference in the incidence of non-specific lesions of the Clitoris versus non-specific lesions of the Urethral Sulcus in patients with vulvar dermatosis.||||0.0010
72621376|NCT02732145|144773193|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of the Clitoris versus non-specific lesions of the Vestibule in patients with vulvar dermatosis?||||||0|||||||t-test proportion|||Parameter: The difference in the incidence of non-specific lesions of the Clitoris versus non-specific lesions of the Vestibule in patients with vulvar dermatosis.||||0.0000
72621377|NCT02732145|144773193|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of Hart's Line versus non-specific lesions of Hymenal Remnants in patients with vulvar dermatosis?||||||0.0208|||||||t-test proportion|||Parameter: The difference in the incidence of non-specific lesions of Hart's Line versus non-specific lesions of Hymenal Remnants in patients with vulvar dermatosis.||||0.0208
72621378|NCT02732145|144773193|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of Hart's Line versus non-specific lesions of Bartholin's Gland Opening in patients with vulvar dermatosis?||||||0.0007|||||||t-test proportion|||Parameter: The difference in the incidence of non-specific lesions of Hart's Line versus non-specific lesions of Bartholin's Gland Opening in patients with vulvar dermatosis.||||0.0007
72621379|NCT02732145|144773193|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of the Urethral Sulcus versus non-specific lesions of Hymenal Remnants in patients with vulvar dermatosis?||||||0.0208|||||||t-test proportion|||Parameter: The difference in the incidence of non-specific lesions of the Urethral Sulcus versus non-specific lesions of Hymenal Remnants in patients with vulvar dermatosis.||||0.0208
72621380|NCT02732145|144773193|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of the Urethral Sulcus versus non-specific lesions of Bartholin's Gland Opening in patients with vulvar dermatosis?||||||0.0007|||||||t-test proportion|||Parameter: The difference in the incidence of non-specific lesions of the Urethral Sulcus versus non-specific lesions of Bartholin's Gland Opening in patients with vulvar dermatosis.||||0.0007
72502887|NCT05139030|144536145|SUPERIORITY|A one-sided hypothesis test was performed at alpha=0.025 level of significance comparing EXPAREL admix and bupivacaine HCI|Mean Ratio|0.77||||0.0018|TWO_SIDED|95.0|0.64|0.92|||ANCOVA|Total opioid consumption was transformed to log scale. Main effect of treatment, covariates: pooled Investigator site (categorical); age (continuous)||The superiority of EXPAREL admixed to bupivacaine HCI was evaluated using the Efficacy Analysis Set.||0.92|0.64|0.0018
72502888|NCT05139030|144536146|SUPERIORITY||Hazard Ratio (HR)|0.7||||0.0127|TWO_SIDED|95.0|0.51|0.96|||Cox proportional hazards model|Cox proportional hazard model: treatment as main effect, pooled Investigator site as categorical, and age and height as continuous covariates||||0.96|0.51|0.0127
72621381|NCT02732145|144773193|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of the Urethral Meatus versus non-specific lesions of the Vestibule in patients with vulvar dermatosis?||||||0.004|||||||t-test proportion|||Parameter: The difference in the incidence of non-specific lesions of the Urethral Meatus versus non-specific lesions of the Vestibule in patients with vulvar dermatosis.||||0.0040
72621382|NCT02732145|144773193|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of Hymenal Remnants versus non-specific lesions of the Vestibule in patients with vulvar dermatosis?||||||0.0012|||||||t-test proportion|||Parameter: The difference in the incidence of non-specific lesions of Hymenal Remnants versus non-specific lesions of the Vestibule in patients with vulvar dermatosis.||||0.0012
72370624|NCT00488683|144251634|SUPERIORITY_OR_OTHER||R-square|0.12||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and hSBA titers one week after booster vaccination for the serogroup C||||
72370625|NCT00488683|144251634|SUPERIORITY_OR_OTHER||R-square|0.23||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and hSBA titers one week after booster vaccination for the serogroup W-135||||
72394252|NCT02509156|144295403|SUPERIORITY||slope of time|-8.07|STANDARD_ERROR_OF_MEAN|1.86||0.0002|TWO_SIDED|||||No adjustments for multiplicity were made in this Phase I trial.|Repeated Measures Linear Regression||"Standard error of the mean is the standard error of the estimate over time of the slope."|Repeated-measures linear regression models were used to address trajectories (upward or downward trends) over time within each of the treatment groups. If there was no significant interaction, only one trajectory (slope) was reported.||||0.0002
72394253|NCT02509156|144295404|SUPERIORITY||Mean Difference (Final Values)|-315.8|STANDARD_ERROR_OF_MEAN|295.0||0.199|TWO_SIDED|95.0|-947.5|315.8|||ANCOVA||Confidence intervals based on t-test|The change in NT-proBNP was compared using ANCOVA analyses adjusting for baseline values. Data log transformed. p-values were obtained from transformed data.||315.80|-947.50|0.199
72394254|NCT02509156|144295405|SUPERIORITY||slope of time|-23.391|STANDARD_ERROR_OF_MEAN|202.08||0.229|TWO_SIDED|||||No adjustments for multiplicity were made in this Phase I trial.|Repeated Measures Linear Regression||"Standard error of the mean is the standard error of the estimate over time of the slope"|Repeated-measures linear regression models were used to address trajectories (upward or downward trends) over time within each of the treatment groups. If there was no significant interaction, only one trajectory (slope) was reported. Log transformation used for the regression. p-values were obtained from transformed data.||||0.229
72394255|NCT01606436|144295441|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.62|||||TWO_SIDED|90.0|-1.2|2.44||||||Comparison at 0.5 hours postdose.||2.44|-1.20|
72394256|NCT01606436|144295441|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|2.89|||||TWO_SIDED|90.0|1.05|4.73||||||Comparison at 2.0 hours postdose.||4.73|1.05|
72465734|NCT02672514|144454422|SUPERIORITY_OR_OTHER|||||||0.377|||||||Wilcoxon (Mann-Whitney)|||The early diagnosis of AKI currently depends on the detection of reduced kidney function by the rise of serum Creatinine concentration. We test the null hypothesis that serum Creatinine was the same in both groups. The first blood samples from both groups were collected before cardiopulmonary bypass.||||0.377
72502889|NCT05139030|144536147|SUPERIORITY||Least square mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.26||0.3674|TWO_SIDED|95.0|-0.6|0.4||Worst pain 0-24 hours|ANCOVA|Main effect of treatment, categorical covariate of pooled Investigator site, and continuous covariates of age||||0.4|-0.6|0.3674
72394257|NCT01606436|144295441|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|2.11|||||TWO_SIDED|90.0|0.28|3.95||||||Comparison at 3.0 hours postdose.||3.95|0.28|
72394258|NCT01606436|144295441|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|1.48|||||TWO_SIDED|90.0|-0.36|3.32||||||Comparison at 4.0 hours postdose.||3.32|-0.36|
72394259|NCT01606436|144295441|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|1.48|||||TWO_SIDED|90.0|-0.36|3.32||||||Comparison at 5.0 hours postdose.||3.32|-0.36|
72465735|NCT02672514|144454422|SUPERIORITY_OR_OTHER|||||||0.051|||||||Wilcoxon (Mann-Whitney)|||The early diagnosis of AKI currently depends on the detection of reduced kidney function by the rise of serum Creatinine concentration. We test the null hypothesis that serum Creatinine was the same in both groups. The blood samples were collected from both groups on arrival of intensive care unit.||||0.051
72465736|NCT02672514|144454422|SUPERIORITY_OR_OTHER|||||||0.282|||||||Wilcoxon (Mann-Whitney)|||The early diagnosis of AKI currently depends on the detection of reduced kidney function by the rise of serum Creatinine concentration. We test the null hypothesis that serum Creatinine was the same in both groups. The blood samples from both groups were collected 24 hours after Operation.||||0.282
72465737|NCT02672514|144454422|SUPERIORITY_OR_OTHER|||||||0.277|||||||Wilcoxon (Mann-Whitney)|||The early diagnosis of AKI currently depends on the detection of reduced kidney function by the rise of serum Creatinine concentration. We test the null hypothesis that serum Creatinine was the same in both groups. These blood samples were collected 48 hours after cardiopulmonary Bypass.||||0.277
72502890|NCT05139030|144536147|SUPERIORITY||Least square mean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.29||0.1016|TWO_SIDED|95.0|-0.9|0.2||Worst pain 24-48 hours|ANCOVA|Main effect of treatment, categorical covariate of pooled Investigator site, and continuous covariates of age||||0.2|-0.9|0.1016
72564226|NCT04230876|144660227|SUPERIORITY||partial eta squared|0.005|||=|0.72|TWO_SIDED|||||Among the 28 participants, changes in the hours per day of hearing aid usage seen after four weeks using the Amptify were compared to the changes seen after four weeks of CC TV every day (F(1,26)=.131).|ANOVA|||||||=0.720
72564227|NCT04230876|144660228|SUPERIORITY||partial eta squared|0.052|||=|0.242|TWO_SIDED|||||Changes in the NU-6 seen after four weeks using the Amptify were compared to the changes seen after four weeks watching 20 minutes of CC TV (F(1,26)=1.43).|ANOVA|||||||=0.242
72394260|NCT01606436|144295441|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|3.48|||||TWO_SIDED|90.0|1.64|5.32||||||Comparison at 6.0 hours postdose.||5.32|1.64|
72394261|NCT01606436|144295441|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|2.12|||||TWO_SIDED|90.0|0.27|3.97||||||Comparison at 8.0 hours postdose.||3.97|0.27|
72394262|NCT01606436|144295441|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|1.67|||||TWO_SIDED|90.0|-0.17|3.51||||||Comparison at 12.0 hours postdose.||3.51|-0.17|
72502891|NCT05139030|144536147|SUPERIORITY||Least square mean difference|-0.7|STANDARD_ERROR_OF_MEAN|0.34||0.0215|TWO_SIDED|95.0|-1.4|0.0||Worst pain 48-72 hours|ANCOVA|Main effect of treatment, categorical covariate of pooled Investigator site, and continuous covariates of age||||-0.0|-1.4|0.0215
72564228|NCT03581188|144660270|SUPERIORITY||Odds Ratio (OR)|3.5|||||TWO_SIDED|95.0|0.9|14.0||||||Odds ratios report differences between groups at follow-up.||14|0.9|
72394263|NCT01606436|144295441|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|1.01|||||TWO_SIDED|90.0|-1.57|3.59||||||Comparison at 0.5 hours postdose.||3.59|-1.57|
72394264|NCT01606436|144295441|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|4.99|||||TWO_SIDED|90.0|2.4|7.57||||||Comparison at 2.0 hours postdose.||7.57|2.40|
72394265|NCT01606436|144295441|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|6.28|||||TWO_SIDED|90.0|3.71|8.86||||||Comparison at 3.0 hours postdose.||8.86|3.71|
72394266|NCT01606436|144295441|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|6.35|||||TWO_SIDED|90.0|3.78|8.93||||||Comparison at 4.0 hours postdose.||8.93|3.78|
72502892|NCT05139030|144536147|SUPERIORITY||Least square mean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.34||0.0794|TWO_SIDED|95.0|-1.2|0.2||Worst pain 72-96 hours|ANCOVA|Main effect of treatment, categorical covariate of pooled Investigator site, and continuous covariates of age||||0.2|-1.2|0.0794
72564229|NCT03581188|144660271|SUPERIORITY||Odds Ratio (OR)|2.2|||||TWO_SIDED|95.0|0.8|5.7||||||||5.7|0.8|
72564230|NCT03581188|144660273|SUPERIORITY||Risk Ratio (RR)|1.5|||||TWO_SIDED|95.0|1.1|2.1||||||||2.1|1.1|
72564231|NCT03581188|144660274|SUPERIORITY||Risk Ratio (RR)|1.1|||||TWO_SIDED|95.0|0.6|2.0||||||||2|0.6|
72621383|NCT02732145|144773193|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of Bartholin's Gland Opening versus non-specific lesions of the Vestibule in patients with vulvar dermatosis?||||||0|||||||t-test proportion|||Parameter: The difference in the incidence of non-specific lesions of Bartholin's Gland Opening versus non-specific lesions of the Vestibule in patients with vulvar dermatosis.||||0.0000
72465738|NCT02672514|144454422|SUPERIORITY_OR_OTHER|||||||0.308|||||||Wilcoxon (Mann-Whitney)|||The early diagnosis of AKI currently depends on the detection of reduced kidney function by the rise of serum Creatinine concentration. We test the null hypothesis that serum Creatinine was the same in both groups. The blood samples were collected from both groups 72 hours after cardiopulmonary bypass.||||0.308
72465739|NCT02672514|144454422|SUPERIORITY_OR_OTHER|||||||0.211|||||||Wilcoxon (Mann-Whitney)|||The early diagnosis of AKI currently depends on the detection of reduced kidney function by the rise of serum Cystatin C concentration. We test the null hypothesis that serum Cystatin C was the same in both groups. The first blood samples were collected before cardiopulmonary bypass.||||0.211
72465740|NCT02672514|144454422|SUPERIORITY_OR_OTHER|||||||0.004|||||||Wilcoxon (Mann-Whitney)|||The early diagnosis of AKI currently depends on the detection of reduced kidney function by the rise of serum Cystatin C concentration. We test the null hypothesis that serum Cystatin C was the same in both groups. The blood samples were collected on arrival of intensive care unit.||||0.004
72465741|NCT02672514|144454422|SUPERIORITY_OR_OTHER|||||||0.221|||||||Wilcoxon (Mann-Whitney)|||The early diagnosis of AKI currently depends on the detection of reduced kidney function by the rise of serum Cystatin C concentration. We test the null hypothesis that serum Cystatin C was the same in both groups. The blood samples were collected 24 hours after operation.||||0.221
72465742|NCT02672514|144454422|SUPERIORITY_OR_OTHER|||||||0.796|||||||Wilcoxon (Mann-Whitney)|||The early diagnosis of AKI currently depends on the detection of reduced kidney function by the rise of serum Cystatin C concentration. We test the null hypothesis that serum Cystatin C was the same in both groups. The blood samples were collected 48 hours after operation.||||0.796
72502893|NCT05139030|144536147|SUPERIORITY||Least square mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.29||0.3606|TWO_SIDED|95.0|-0.7|0.5||Average pain 0-24 hours|ANCOVA|Main effect of treatment, categorical covariate of pooled Investigator site, and continuous covariates of age||||0.5|-0.7|0.3606
72621384|NCT02732145|144773193|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of Hart's Line versus non-specific lesions of the Urethral Meatus in patients with vulvodynia?||||||0.0048|||||||t-test proportion|||"Parameter: The difference in the incidence of non-specific lesions of Hart's Line versus non-specific lesions of the Urethral Meatus in patients with vulvodynia.~The diagnosis of vulvodynia was based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection, Q-Tip) following Friedrich's criteria. Vulvoscopic lesions were not relevant to the diagnosis of vulvodynia."||||0.0048
72370626|NCT00488683|144251634|SUPERIORITY_OR_OTHER||R-square|0.96||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and hSBA titers one week after booster vaccination for the serogroup Y||||
72370627|NCT00488683|144251634|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|0.18||||0.46||95.0|||||Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one week after booster vaccination for the serogroup A||||0.46
72370628|NCT00488683|144251634|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|-0.03||||0.9||95.0|||||Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one week after booster vaccination for the serogroup C||||0.90
72370629|NCT00488683|144251634|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|0.51||||0.008||95.0|||||Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one week after booster vaccination for the serogroup W-135||||0.008
72370630|NCT00488683|144251634|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|0.42||||0.08||95.0|||||Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one week after booster vaccination for the serogroup Y||||0.08
72370631|NCT00488683|144251634|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.15||||0.52||95.0|||||Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one week after booster vaccination for the serogroup A||||0.52
72370632|NCT00488683|144251634|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.27||||0.18||95.0|||||Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one week after booster vaccination for the serogroup C||||0.18
72370633|NCT00488683|144251634|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.37||||0.07||95.0|||||Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one week after booster vaccination for the serogroup W-135||||0.07
72370634|NCT00488683|144251634|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.14||||0.55||95.0|||||Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one week after booster vaccination for the serogroup Y||||0.55
72370635|NCT00488683|144251634|SUPERIORITY_OR_OTHER||R-square|0.03||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one week after booster vaccination for the serogroup A||||
72370636|NCT00488683|144251634|SUPERIORITY_OR_OTHER||R-square|0.0007||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one week after booster vaccination for the serogroup C||||
72370637|NCT00488683|144251634|SUPERIORITY_OR_OTHER||R-square|0.27||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one week after booster vaccination for the serogroup W-135||||
72370638|NCT00488683|144251634|SUPERIORITY_OR_OTHER||R-square|0.17||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one week after booster vaccination for the serogroup Y||||
72621385|NCT02732145|144773193|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of Hart's Line versus non-specific lesions of Hymenal Remnants in patients with vulvodynia?||||||0.0007|||||||t-test proportion|||"Parameter: The difference in the incidence of non-specific lesions of Hart's Line versus non-specific lesions of Hymenal Remnants in patients with vulvodynia.~The diagnosis of vulvodynia was based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection, Q-Tip) following Friedrich's criteria. Vulvoscopic lesions were not relevant to the diagnosis of vulvodynia."||||0.0007
72621386|NCT02732145|144773193|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of the Urethral Sulcus versus non-specific lesions of the Urethral Meatus in patients with vulvodynia?||||||0.0048|||||||t-test proportion|||"Parameter: The difference in the incidence of non-specific lesions of the Urethral Sulcus versus non-specific lesions of the Urethral Meatus in patients with vulvodynia.~The diagnosis of vulvodynia was based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection, Q-Tip) following Friedrich's criteria. Vulvoscopic lesions were not relevant to the diagnosis of vulvodynia."||||0.0048
72621387|NCT02732145|144773193|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of the Urethral Sulcus versus non-specific lesions of Hymenal Remnants in patients with vulvodynia?||||||0.0007|||||||t-test proportion|||"Parameter: The difference in the incidence of non-specific lesions of the Urethral Sulcus versus non-specific lesions of Hymenal Remnants in patients with vulvodynia.~The diagnosis of vulvodynia was based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection, Q-Tip) following Friedrich's criteria. Vulvoscopic lesions were not relevant to the diagnosis of vulvodynia."||||0.0007
72621388|NCT02732145|144773193|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of the Urethral Meatus versus non-specific lesions of the Vestibule in patients with vulvodynia?||||||0.0131|||||||t-test proportion|||"Parameter: The difference in the incidence of non-specific lesions of the Urethral Meatus versus non-specific lesions of the Vestibule in patients with vulvodynia.~The diagnosis of vulvodynia was based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection, Q-Tip) following Friedrich's criteria. Vulvoscopic lesions were not relevant to the diagnosis of vulvodynia."||||0.0131
72370639|NCT00488683|144251635|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|0.45||||0.0006||95.0|||||Parametric correlation||Values from Group 1, 2 and 3 were combined for this analysis.|Pearson correlation coefficient between CRM197 specific memory B cells one month after primary vaccination and CRM197 specific memory B cells at 12 months of age||||0.0006
72370640|NCT00488683|144251635|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.41||||0.0021||95.0|||||Non-parametric correlation||Values from Group 1, 2 and 3 were combined for this analysis.|Spearman correlation coefficient between CRM197 specific memory B cells one month after primary vaccination and CRM197 specific memory B cells at 12 months of age||||0.0021
72564232|NCT03581188|144660275|SUPERIORITY||Risk Difference (RD)|10.0|||||TWO_SIDED|95.0|-2.0|23.0||||||For new melanoma diagnoses, we calculated the difference in proportions and confidence intervals using the χ2 method without continuity correction. We included baseline measurement of the outcome in the models as a covariate to estimate between group difference in change from baseline.||23|-2|
72564233|NCT03581188|144660276|SUPERIORITY||Risk Difference (RD)|10.0|||||TWO_SIDED|95.0|2.0|19.0||||||New melanoma diagnoses prompted at unscheduled visit||19|2|
72564234|NCT03581188|144660276|SUPERIORITY||Risk Ratio (RR)|0.0|||||TWO_SIDED|95.0|-9.0|10.0||||||New melanoma diagnoses prompted at scheduled visit||10|-9|
72564235|NCT03581188|144660277|SUPERIORITY||Mean Difference (Net)|-1.4|||||TWO_SIDED|95.0|-5.8|3.0||||||||3|-5.8|
72564236|NCT03064438|144660278|SUPERIORITY||Difference of Least Squares (LS) Mean|1.8|STANDARD_ERROR_OF_MEAN|1.95||0.366|TWO_SIDED|95.0|-2.162|5.727|||t-test, 2 sided|||||5.727|-2.162|0.366
72564237|NCT03064438|144660279|SUPERIORITY|||||||0.1099|||||||Van Elteren test|||Percent change from baseline at Week 2||||0.1099
72621389|NCT02732145|144773193|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of Hymenal Remnants versus non-specific lesions of Bartholin's Gland Opening in patients with vulvodynia?||||||0.0423|||||||t-test proportion|||"Parameter: The difference in the incidence of non-specific lesions of Hymenal Remnants versus non-specific lesions of Bartholin's Gland Opening in patients with vulvodynia.~The diagnosis of vulvodynia was based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection, Q-Tip) following Friedrich's criteria. Vulvoscopic lesions were not relevant to the diagnosis of vulvodynia."||||0.0423
72621390|NCT02732145|144773193|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of Hymenal Remnants versus non-specific lesions of the Vestibule in patients with vulvodynia?||||||0.0021|||||||t-test proportion|||"Parameter: The difference in the incidence of non-specific lesions of Hymenal Remnants versus non-specific lesions of the Vestibule in patients with vulvodynia.~The diagnosis of vulvodynia was based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection, Q-Tip) following Friedrich's criteria. Vulvoscopic lesions were not relevant to the diagnosis of vulvodynia."||||0.0021
72621391|NCT02732145|144773193|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of the Clitoris versus non-specific lesions of Hart's Line in patients with impaired vulvar skin?||||||0|||||||t-test proportion|||Parameter: The difference in the incidence of non-specific lesions of the Clitoris versus non-specific lesions of Hart's Line in patients with impaired vulvar skin.||||0.0000
72465743|NCT02672514|144454422|SUPERIORITY_OR_OTHER|||||||0.463|||||||Wilcoxon (Mann-Whitney)|||The early diagnosis of AKI currently depends on the detection of reduced kidney function by the rise of serum Cystatin C concentration. We test the null hypothesis that serum Cystatin C was the same in both groups. The blood samples were collected 72 hours after operation.||||0.463
72564238|NCT03064438|144660279|SUPERIORITY|||||||0.1653|||||||Van Elteren test|||Percent change from baseline at Week 4||||0.1653
72564239|NCT03064438|144660279|SUPERIORITY|||||||0.8437|||||||Van Elteren test|||Percent change from baseline at Week 8||||0.8437
72564240|NCT03064438|144660279|SUPERIORITY|||||||0.4644|||||||Van Elteren test|||Percent change from baseline at Week 12||||0.4644
72564241|NCT03064438|144660280|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.0
72564242|NCT03064438|144660281|SUPERIORITY||Difference of LS Mean|1.3|STANDARD_ERROR_OF_MEAN|1.91||0.495|TWO_SIDED|95.0|-2.571|5.211|||t-test, 2 sided|||Change from baseline at Week 2||5.211|-2.571|0.495
72621392|NCT02732145|144773193|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of the Clitoris versus non-specific lesions of the Urethral Sulcus in patients with impaired vulvar skin?||||||0|||||||t-test proportion|||Parameter: The difference in the incidence of non-specific lesions of the Clitoris versus non-specific lesions of the Urethral Sulcus in patients with impaired vulvar skin.||||0.0000
72621393|NCT02732145|144773193|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of the Clitoris versus non-specific lesions of the Vestibule in patients with impaired vulvar skin?||||||0.0091|||||||t-test proportion|||Parameter: The difference in the incidence of non-specific lesions of the Clitoris versus non-specific lesions of the Vestibule in patients with impaired vulvar skin.||||0.0091
72621394|NCT02732145|144773193|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of Hart's Line versus non-specific lesions of the Urethral Meatus in patients with impaired vulvar skin?||||||0.0002|||||||t-test proportion|||Parameter: The difference in the incidence of non-specific lesions of Hart's Line versus non-specific lesions of the Urethral Meatus in patients with impaired vulvar skin.||||0.0002
72621395|NCT02732145|144773193|EQUIVALENCE|Question: Is there a difference in the incidence of non-specific lesions of Hart's Line versus non-specific lesions of Hymenal Remnants in patients with impaired vulvar skin?||||||0|||||||t-test proportion|||Parameter: The difference in the incidence of non-specific lesions of Hart's Line versus non-specific lesions of Hymenal Remnants in patients with impaired vulvar skin.||||0.0000
72564243|NCT03064438|144660281|SUPERIORITY||Difference of LS Mean|-1.5|STANDARD_ERROR_OF_MEAN|1.74||0.399|TWO_SIDED|95.0|-5.014|2.045|||t-test, 2 sided|||Change from baseline at Week 4||2.045|-5.014|0.399
72564244|NCT03064438|144660281|SUPERIORITY||Difference of LS Mean|2.2|STANDARD_ERROR_OF_MEAN|2.07||0.29|TWO_SIDED|95.0|-1.965|6.407|||t-test, 2 sided|||Change from baseline at Week 8||6.407|-1.965|0.290
72564245|NCT03064438|144660281|SUPERIORITY||Difference of LS Mean|1.8|STANDARD_ERROR_OF_MEAN|1.83||0.343|TWO_SIDED|95.0|-1.953|5.469|||t-test, 2 sided|||Change from baseline at Week 12||5.469|-1.953|0.343
72564246|NCT03064438|144660282|SUPERIORITY||Difference of LS Mean|0.6|STANDARD_ERROR_OF_MEAN|0.75||0.407|TWO_SIDED|95.0|-0.894|2.155|||t-test, 2 sided|||Change from baseline at Week 2||2.155|-0.894|0.407
72564247|NCT03064438|144660282|SUPERIORITY||Difference of LS Mean|0.4|STANDARD_ERROR_OF_MEAN|0.36||0.291|TWO_SIDED|95.0|-0.342|1.109|||t-test, 2 sided|||Change from baseline at Week 4||1.109|-0.342|0.291
72564248|NCT03064438|144660282|SUPERIORITY||Difference of LS Mean|0.2|STANDARD_ERROR_OF_MEAN|0.45||0.734|TWO_SIDED|95.0|-0.763|1.073|||t-test, 2 sided|||Change from baseline at Week 8||1.073|-0.763|0.734
72564249|NCT03064438|144660282|SUPERIORITY||Difference of LS Mean|0.0|STANDARD_ERROR_OF_MEAN|0.57||0.952|TWO_SIDED|95.0|-1.128|1.197|||t-test, 2 sided|||Change from baseline in pustule lesions at Week 12||1.197|-1.128|0.952
72564250|NCT03064438|144660283|SUPERIORITY||Difference of LS Mean|-0.1|STANDARD_ERROR_OF_MEAN|0.07||0.313|TWO_SIDED|95.0|-0.215|0.069|||t-test, 2 sided|||Change from baseline at Week 2||0.069|-0.215|0.313
72564251|NCT03064438|144660283|SUPERIORITY||Difference of LS Mean|0.0|STANDARD_ERROR_OF_MEAN|0.07||0.942|TWO_SIDED|95.0|-0.141|0.152|||t-test, 2 sided|||Change from baseline at Week 4||0.152|-0.141|0.942
72564252|NCT03064438|144660283|SUPERIORITY||Difference of LS Mean|0.1|STANDARD_ERROR_OF_MEAN|0.07||0.284|TWO_SIDED|95.0|-0.067|0.226|||t-test, 2 sided|||Change from baseline in nodule lesions at Week 8||0.226|-0.067|0.284
72564253|NCT03064438|144660283|SUPERIORITY||Difference of LS Mean|0.0|STANDARD_ERROR_OF_MEAN|0.08||0.542|TWO_SIDED|95.0|-0.198|0.105|||t-test, 2 sided|||Change from baseline at Week 12||0.105|-0.198|0.542
72564254|NCT03064438|144660284|SUPERIORITY||Difference of LS Mean|2.0|STANDARD_ERROR_OF_MEAN|2.04||0.333|TWO_SIDED|95.0|-2.135|6.139|||t-test, 2 sided|||Change from baseline at Week 2||6.139|-2.135|0.333
72564255|NCT03064438|144660284|SUPERIORITY||Difference of LS Mean|-1.0|STANDARD_ERROR_OF_MEAN|1.9||0.591|TWO_SIDED|95.0|-4.882|2.822|||t-test, 2 sided|||Change from baseline at Week 4||2.822|-4.882|0.591
72564256|NCT03064438|144660284|SUPERIORITY||Difference of LS Mean|2.5|STANDARD_ERROR_OF_MEAN|2.12||0.254|TWO_SIDED|95.0|-1.84|6.758|||t-test, 2 sided|||Change from baseline at Week 8||6.758|-1.840|0.254
72564257|NCT03064438|144660284|SUPERIORITY||Difference of LS Mean|1.8|STANDARD_ERROR_OF_MEAN|1.95||0.356|TWO_SIDED|95.0|-2.131|5.779|||t-test, 2 sided|||Change from baseline at Week 12||5.779|-2.131|0.356
72564258|NCT03407612|144660316|EQUIVALENCE|p \< 0.05 required for groups to have non-equivalent results.||||||0.67|||||||t-test, 2 sided|||This analysis considers the baseline HOS-ADL measures.||||0.67
72564259|NCT03407612|144660316|EQUIVALENCE|p \< 0.05 required for groups to have non-equivalent results.||||||0.73|||||||t-test, 2 sided|||This analysis considers the 6 week postoperative HOS-ADL measures.||||0.73
72564260|NCT03407612|144660316|EQUIVALENCE|p \< 0.05 required for groups to have non-equivalent results.||||||0.87|||||||t-test, 2 sided|||This analysis considers the 12 week postoperative HOS-ADL measures.||||0.87
72564261|NCT03407612|144660316|EQUIVALENCE|p \< 0.05 required for groups to have non-equivalent results.||||||0.78|||||||t-test, 2 sided|||This analysis considers the 6 month postoperative HOS-ADL measures.||||0.78
72564262|NCT03407612|144660317|EQUIVALENCE|p \< 0.05 required for groups to have non-equivalent results.||||||0.25|||||||t-test, 2 sided|||||||0.25
72564263|NCT03407612|144660318|EQUIVALENCE|p \< 0.05 required for groups to have non-equivalent results.||||||0.04|||||||t-test, 2 sided|||||||0.04
72564264|NCT02065713|144660331|SUPERIORITY||||||=|0.026|||||||Wilcoxon (Mann-Whitney)|||||||=0.026
72564265|NCT03614494|144660332|SUPERIORITY||Risk Difference (RD)|31.4|||<|0.0001|TWO_SIDED|95.0|26.2|36.4|||Chi-squared|||||36.4|26.2|<0.0001
72564266|NCT03614494|144660333|SUPERIORITY||Odds Ratio (OR)|0.197||||0.036|TWO_SIDED|95.0|0.021|0.906|||Logistic regression, Firth's bias reduct|||||0.906|0.021|0.036
72564267|NCT01652729|144660334|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.72|STANDARD_ERROR_OF_MEAN|0.2167||0.001|TWO_SIDED|95.0|-1.15|-0.3|||mixed model for repeated measure|MMRM includes treatment, baseline HbA1c (\<9% or ≥9%), week of visit and treatment by visit interaction as fixed factors, and subject random effect.||||-0.30|-1.15|0.0010
72564268|NCT01652729|144660334|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.38|STANDARD_ERROR_OF_MEAN|0.1638||0.0209|TWO_SIDED|95.0|-0.7|-0.06|||mixed model for repeated measure|MMRM includes treatment, baseline HbA1c (\<9% or ≥9%), week of visit and treatment by visit interaction as fixed factors, and subject random effect.||||-0.06|-0.70|0.0209
72564269|NCT01652729|144660334|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.34|STANDARD_ERROR_OF_MEAN|0.2278||0.1347|TWO_SIDED|95.0|-0.79|0.11|||mixed model for repeated measure|MMRM includes treatment, baseline HbA1c (\<9% or ≥9%), week of visit and treatment by visit interaction as fixed factors, and subject random effect.||||0.11|-0.79|0.1347
72564270|NCT01652729|144660335|SUPERIORITY_OR_OTHER|||||||0.0489|||||||Cochran-Mantel-Haenszel|||Percentage of Subjects Achieving HbA1c \<7% at Week 28.||||0.0489
72564271|NCT01652729|144660335|SUPERIORITY_OR_OTHER|||||||0.0103|||||||Cochran-Mantel-Haenszel|||Percentage of Subjects Achieving HbA1c \<7% at Week 28.||||0.0103
72564272|NCT01652729|144660336|SUPERIORITY_OR_OTHER||LS Mean Difference|-10.1|STANDARD_ERROR_OF_MEAN|5.96||0.0924|TWO_SIDED|95.0|-21.8|1.7|||mixed model for repeated measure|MMRM includes treatment, baseline HbA1c (\<9% or ≥9%), week of visit and treatment by visit interaction as fixed factors, and subject random effect.||||1.7|-21.8|0.0924
72621396|NCT02732145|144773193|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of Hart's Line versus non-specific lesions of Bartholin's Gland Opening in patients with impaired vulvar skin?||||||0.0013|||||||t-test proportion|||Parameter: The difference in the incidence of non-specific lesions of Hart's Line versus non-specific lesions of Bartholin's Gland Opening in patients with impaired vulvar skin.||||0.0013
72564273|NCT01652729|144660336|SUPERIORITY_OR_OTHER||LS Mean Difference|-30.9|STANDARD_ERROR_OF_MEAN|8.037||0.0001|TWO_SIDED|95.0|-46.7|-15.1|||mixed model for repeated measure|MMRM includes treatment, baseline HbA1c (\<9% or ≥9%), week of visit and treatment by visit interaction as fixed factors, and subject random effect.||||-15.1|-46.7|0.0001
72564274|NCT01652729|144660337|SUPERIORITY_OR_OTHER||LS Mean Difference|0.07|STANDARD_ERROR_OF_MEAN|0.4058||0.8625|TWO_SIDED|95.0|-0.73|0.87||Nominal p-value|mixed model for repeated measure|MMRM includes treatment, baseline HbA1c (\<9% or ≥9%), week of visit and treatment by visit interaction as fixed factors, and subject random effect.||||0.87|-0.73|0.8625
72564275|NCT01652729|144660337|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.27|STANDARD_ERROR_OF_MEAN|0.5419||0.0198|TWO_SIDED|95.0|-2.34|-0.2||Nominal p-value|mixed model for repeated measure|MMRM includes treatment, baseline HbA1c (\<9% or ≥9%), week of visit and treatment by visit interaction as fixed factors, and subject random effect.||||-0.20|-2.34|0.0198
72564276|NCT01652729|144660338|SUPERIORITY_OR_OTHER||LS Mean Difference|-35.96|STANDARD_ERROR_OF_MEAN|15.71||0.0248|TWO_SIDED|95.0|-67.23|-4.68||Nominal p-value|general linear model|Includes treatment and baseline HbA1c (\< 9% or ≥ 9%) as fixed factors, and baseline 2-hour postprandial plasma glucose concentrations as a covariate.||||-4.68|-67.23|0.0248
72564277|NCT01652729|144660338|SUPERIORITY_OR_OTHER||LS Mean Difference|-20.89|STANDARD_ERROR_OF_MEAN|19.66||0.2914|TWO_SIDED|95.0|-60.02|18.25||Nominal p-value|general linear model|Includes treatment and baseline HbA1c (\< 9% or ≥ 9%) as fixed factors, and baseline 2-hour postprandial plasma glucose concentrations as a covariate.||||18.25|-60.02|0.2914
72564278|NCT00483548|144660339|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|-0.36|STANDARD_ERROR_OF_MEAN|1.37||0.7921||95.0|-3.07|2.34||Due to planned interim analysis of primary endpoint, to control type I error at 2-sided alpha=0.05, a nominal 2-sided p-value ≤0.0476 needed at final analysis to reject the null hypothesis of no treatment effect.|ANCOVA Mixed-effects repeated-measures|No other adjustment made for multiple comparisons since all comparisons, except for single primary comparison, are considered secondary.|Mixed-effects repeated-measures (MMRM) analysis of covariance model: fixed categorical effects of treatment, country, mood stabilizer type, visit, treatment-by-visit interaction, fixed continuous effect of baseline value and subject as random effect.|N=141 per arm (282 total) needed for 85% power for 2-sided alpha=0.05 based on true mean difference=4.0 and standard deviation (SD)=11.0 for primary endpoint. Interim Analysis (IA) planned when 60% of subjects had completed study or discontinued prematurely to assess efficacy (nominal 2-sided p-value less than or equal to \[≤\] 0.0076) or futility (nominal 2-sided p-value greater than or equal to \[≥\] 0.5099).||2.34|-3.07|0.7921
72564279|NCT00483548|144660340|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|0.06|STANDARD_ERROR_OF_MEAN|0.16||0.7223||95.0|-0.25|0.36|||ANCOVA Mixed-effects repeated-measures|||Week 6; MMRM analysis of covariance model with fixed categorical effects of treatment, country, type of mood stabilizer, visit, treatment-by-visit interaction, fixed continuous effect of baseline value and subject as random effect.||0.36|-0.25|0.7223
72564280|NCT00483548|144660341|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.846||||0.5029||95.0|0.52|1.38|||Regression, Logistic||Odds ratio measures the odds of achieving remission (MADRS total score ≤ 12) from ziprasidone treated subjects versus placebo; a value \> 1 favors ziprasidone.|Week 6; LOCF; Logistic regression model with treatment, country, and type of mood stabilizer.||1.38|0.52|0.5029
72564281|NCT00483548|144660342|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.949||||0.8266||95.0|0.59|1.52|||Regression, Logistic||Odds ratio measures the odds of achieving response (≥ 50 % reduction in MADRS total score) from ziprasidone treated subjects versus placebo; a value \> 1 favors ziprasidone.|Week 6; LOCF; Logistic regression model with treatment, country, and type of mood stabilizer.||1.52|0.59|0.8266
72564282|NCT00483548|144660343|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.939||||0.7924||95.0|0.59|1.5||Logistic regression model with treatment, country, and type of mood stabilizer.|Regression, Logistic|||Week 6; LOCF; Logistic regression model with treatment, country, and type of mood stabilizer.||1.50|0.59|0.7924
72564283|NCT00483548|144660344|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|-1.68|STANDARD_ERROR_OF_MEAN|0.89||0.0594||95.0|-3.42|0.07|||ANCOVA|||Week 1; LOCF; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.||0.07|-3.42|0.0594
72394267|NCT01606436|144295441|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|4.71|||||TWO_SIDED|90.0|2.11|7.31||||||Comparison at 12.0 hours postdose.||7.31|2.11|
72394268|NCT01025752|144295449|NON_INFERIORITY|A 20% (1.4) reduction in NRS for pain intensity from baseline was considered minimally clinically important the non-inferiority margin was set at one NRS unit. The required sample size was 230 participants. Because enrollment was slower than expected and the standard deviation in the primary outcome was less than the initial power calculation (1.6 vs. 2.45) we conducted a sample size recalculation, based on observed data to determine that we would need 42 completers per arm for 80% power.|Mean Difference (Final Values)|0.07||||0.007|TWO_SIDED|95.0|-0.67|0.8||Non-inferiority margin of 1|Mixed Models Analysis|The models includes treatment arm, time, treatment-by-time interaction, baseline NRS, stratification variables (distance from VA \& back pain cause)|The upper limit (0.80) fell below the non-inferiority margin of 1.|post-treatment (12 weeks) time point||0.80|-0.67|0.007
72564284|NCT00483548|144660344|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|-1.25|STANDARD_ERROR_OF_MEAN|1.03||0.223||95.0|-3.27|0.77|||ANCOVA|||Week 2; LOCF; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.||0.77|-3.27|0.2230
72621397|NCT02732145|144773193|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of the Urethral Sulcus versus non-specific lesions of the Urethral Meatus in patients with impaired vulvar skin?||||||0.0001|||||||t-test proportion|||Parameter: The difference in the incidence of non-specific lesions of the Urethral Sulcus versus non-specific lesions of the Urethral Meatus in patients with impaired vulvar skin.||||0.0001
72621398|NCT02732145|144773193|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of the Urethral Sulcus versus non-specific lesions of Hymenal Remnants in patients with impaired vulvar skin?||||||0|||||||t-test proportion|||Parameter: The difference in the incidence of non-specific lesions of the Urethral Sulcus versus non-specific lesions of Hymenal Remnants in patients with impaired vulvar skin.||||0.0000
72621399|NCT02732145|144773193|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of the Urethral Sulcus versus non-specific lesions of Bartholin's Gland Opening in patients with impaired vulvar skin?||||||0.0008|||||||t-test proportion|||Parameter: The difference in the incidence of non-specific lesions of the Urethral Sulcus versus non-specific lesions of Bartholin's Gland Opening in patients with impaired vulvar skin.||||0.0008
72564285|NCT00483548|144660344|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|-0.43|STANDARD_ERROR_OF_MEAN|1.09||0.6971||95.0|-2.57|1.72|||ANCOVA|||Week 3; LOCF; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.||1.72|-2.57|0.6971
72564286|NCT00483548|144660344|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|-0.68|STANDARD_ERROR_OF_MEAN|1.12||0.5485||95.0|-2.89|1.54|||ANCOVA|||Week 4; LOCF; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.||1.54|-2.89|0.5485
72564287|NCT00483548|144660344|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|-0.25|STANDARD_ERROR_OF_MEAN|1.19||0.8322||95.0|-2.6|2.1|||ANCOVA|||Week 5; LOCF; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.||2.10|-2.60|0.8322
72465744|NCT02672514|144454422|SUPERIORITY_OR_OTHER|||||||0.118|||||||Wilcoxon (Mann-Whitney)|||The early diagnosis of AKI currently depends on the detection of reduced kidney function by the rise of the postoperative NGAL levels in plasma. We test the null hypothesis that the NGAL level was the same in both groups. The first blood samples were collected before cardiopulmonary bypass.||||0.118
72465745|NCT02672514|144454422|SUPERIORITY_OR_OTHER|||||||0.0001|||||||Wilcoxon (Mann-Whitney)|||The early diagnosis of AKI currently depends on the detection of reduced kidney function by the rise of the postoperative NGAL levels in plasma. We test the null hypothesis that the NGAL level was the same in both groups. The blood samples were collected on arrival of intensive care unit.||||0.0001
72465746|NCT02672514|144454422|SUPERIORITY_OR_OTHER|||||||0.0001|||||||Wilcoxon (Mann-Whitney)|||The early diagnosis of AKI currently depends on the detection of reduced kidney function by the rise of the postoperative NGAL levels in plasma. We test the null hypothesis that the NGAL level was the same in both groups. The blood samples were collected one hour after cardiopulmonary bypass.||||0.0001
72465747|NCT02672514|144454422|SUPERIORITY_OR_OTHER|||||||0.0001|||||||Wilcoxon (Mann-Whitney)|||The early diagnosis of AKI currently depends on the detection of reduced kidney function by the rise of the postoperative NGAL levels in plasma. We test the null hypothesis that the NGAL level was the same in both groups. The blood samples were collected four hours after cardiopulmonary bypass.||||0.0001
72465748|NCT02672514|144454422|SUPERIORITY_OR_OTHER|||||||0.171|||||||Wilcoxon (Mann-Whitney)|||The early diagnosis of AKI currently depends on the detection of reduced kidney function by the rise of the postoperative NGAL levels in plasma. We test the null hypothesis that the NGAL level was the same in both groups. The blood samples were collected 48 hours after cardiopulmonary bypass.||||0.171
72465749|NCT02154347|144454424|SUPERIORITY||Mean Difference (Final Values)|-0.66|||<|0.001|TWO_SIDED|95.0|-0.95|-0.37|||t-test, 2 sided|||||-0.37|-0.95|<0.001
72465750|NCT02188784|144454425|SUPERIORITY_OR_OTHER||Mean Difference (Net)|21.03||||0.457|TWO_SIDED|95.0|-34.38|76.43|||Regression, Linear|||||76.43|-34.38|0.4570
72465751|NCT02188784|144454426|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.77||||0.9487|TWO_SIDED|95.0|-24.12|22.59|||Regression, Linear|||Change from Baseline to Week 8||22.59|-24.12|0.9487
72564288|NCT00483548|144660345|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|-0.12|STANDARD_ERROR_OF_MEAN|0.09||0.1771||95.0|-0.29|0.05|||ANCOVA|||Week 1; LOCF; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.||0.05|-0.29|0.1771
72564289|NCT00483548|144660345|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|-0.15|STANDARD_ERROR_OF_MEAN|0.11||0.1765||95.0|-0.37|0.07|||ANCOVA|||Week 2; LOCF; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.||0.07|-0.37|0.1765
72564290|NCT00483548|144660345|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|-0.05|STANDARD_ERROR_OF_MEAN|0.11||0.6765||95.0|-0.27|0.18|||ANCOVA|||Week 3; LOCF; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.||0.18|-0.27|0.6765
72564291|NCT00483548|144660345|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|0.0|STANDARD_ERROR_OF_MEAN|0.12||0.977||95.0|-0.24|0.25|||ANCOVA|||Week 4; LOCF; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.||0.25|-0.24|0.9770
72564292|NCT00483548|144660345|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|-0.04|STANDARD_ERROR_OF_MEAN|0.13||0.7907||95.0|-0.3|0.23|||ANCOVA|||Week 5; LOCF; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.||0.23|-0.30|0.7907
72564293|NCT00483548|144660346|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|-0.22|STANDARD_ERROR_OF_MEAN|0.11||0.0392||95.0|-0.43|-0.01|||ANOVA|||Week 1; LOCF; Analysis of variance model with treatment, country, type of mood stabilizer as fixed effects.||-0.01|-0.43|0.0392
72564294|NCT00483548|144660346|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|-0.14|STANDARD_ERROR_OF_MEAN|0.13||0.2803||95.0|-0.38|0.11|||ANOVA|||Week 2; LOCF; Analysis of variance model with treatment, country, type of mood stabilizer as fixed effects.||0.11|-0.38|0.2803
72564295|NCT00483548|144660346|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|0.0|STANDARD_ERROR_OF_MEAN|0.13||0.9835||95.0|-0.26|0.26|||ANOVA|||Week 3; LOCF; Analysis of variance model with treatment, country, type of mood stabilizer as fixed effects.||0.26|-0.26|0.9835
72465752|NCT02188784|144454426|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-12.67||||0.1921|TWO_SIDED|95.0|-31.71|6.37|||Regression, Linear|||Change from Baseline to Week 16||6.37|-31.71|0.1921
72465753|NCT02188784|144454427|SUPERIORITY_OR_OTHER||Mean Difference (Net)|182.43||||0.4296|TWO_SIDED|95.0|-272.14|637.0|||Regression, Linear|||||637.0|-272.14|0.4296
72465754|NCT02188784|144454428|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.6||||0.0722|TWO_SIDED|95.0|-0.33|7.52|||Regression, Linear|||Change from baseline to week 8||7.52|-0.33|0.0722
72465755|NCT02188784|144454428|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.71||||0.6927|TWO_SIDED|95.0|-2.83|4.24|||Regression, Linear|||Change from baseline to week 16||4.24|-2.83|0.6927
72465756|NCT02188784|144454429|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.56||||0.0643|TWO_SIDED|95.0|-0.21|7.33|||Regression, Linear|||||7.33|-0.21|0.0643
72465757|NCT02188784|144454430|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.77||||0.4006|TWO_SIDED|95.0|-1.04|2.58|||Regression, Linear|||||2.58|-1.04|0.4006
72465758|NCT01171183|144454462|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|3.52|STANDARD_DEVIATION|37.64||0.05|TWO_SIDED||||||t-test, 2 sided|||||||0.05
72465759|NCT01171183|144454463|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.73|STANDARD_DEVIATION|4.54||0.05|TWO_SIDED||||||t-test, 2 sided|||||||0.05
72465760|NCT04333732|144454493|SUPERIORITY||Risk Difference (RD)|0.3||||0.52|TWO_SIDED|95.0|-0.5|1.1|||Regression, Logistic|||The primary endpoint was analysed using a Bayesian logistic regression, including as covariates the treatment arm, age (\<50 vs. ≥50), and a random effect for site||1.1|-0.5|0.52
72465761|NCT04333732|144454494|SUPERIORITY||Risk Difference (RD)|0.04||||0.95|TWO_SIDED|95.0|-1.4|1.3|||Regression, Logistic|difference, 0·04%, 95% CI, -1·4% to 1·3%, p=0·95).||The endpoint was analysed using a Bayesian logistic regression, including as covariates the treatment arm, age (\<50 vs. ≥50), and a random effect for site||1.3|-1.4|0.95
72465762|NCT04190225|144454511|SUPERIORITY||Median Difference (Final Values)|18.4||||0.04|TWO_SIDED|95.0|4.67|37.28|||quantile regression||Median difference is not the difference in the two medians, but is the median of differences between groups (why it is 18.4 and not 23)|||37.28|4.67|0.04
72465763|NCT04190225|144454512|SUPERIORITY||Median Difference (Final Values)|23.5||||0.03|TWO_SIDED|95.0|8.35|32.76|||quantile regression|||||32.76|8.35|0.03
72394269|NCT01025752|144295449|NON_INFERIORITY|A 20% (1.4) reduction in NRS for pain intensity from baseline was considered minimally clinically important the non-inferiority margin was set at one NRS unit. The required sample size was 230 participants. Because enrollment was slower than expected and the standard deviation in the primary outcome was less than the initial power calculation (1.6 vs. 2.45) we conducted a sample size recalculation, based on observed data to determine that we would need 42 completers per arm for 80% power.|Mean Difference (Final Values)|-0.23|||<|0.0001|TWO_SIDED|95.0|-0.94|0.49||Non-inferiority margin of 1|Mixed Models Analysis|The models includes treatment arm, time, treatment-by-time interaction, baseline NRS, stratification variables (distance from VA \& back pain cause)|The upper limit (0.49) fell below the non-inferiority margin of 1.|3 month post-baseline time point||0.49|-0.94|<0.0001
72394270|NCT01025752|144295449|NON_INFERIORITY|A 20% (1.4) reduction in NRS for pain intensity from baseline was considered minimally clinically important the non-inferiority margin was set at one NRS unit. The required sample size was 230 participants. Because enrollment was slower than expected and the standard deviation in the primary outcome was less than the initial power calculation (1.6 vs. 2.45) we conducted a sample size recalculation, based on observed data to determine that we would need 42 completers per arm for 80% power.|Mean Difference (Final Values)|-0.08||||0.004|TWO_SIDED|95.0|-0.86|0.71||The non-inferiority margin is 1.|Mixed Models Analysis|The models includes treatment arm, time, treatment-by-time interaction, baseline NRS, stratification variables (distance from VA \& back pain cause)|The upper limit (0.71) fell below the non-inferiority margin of 1.|6 month post- baseline time point.||0.71|-0.86|0.004
72394271|NCT01025752|144295450|OTHER||Mean Difference (Final Values)|-0.33||||0.12|TWO_SIDED|95.0|-0.74|0.09|||Mixed Models Analysis|||Post-treatment (12 weeks) time point. (Mean difference of IVR CBT- F2F CBT)||0.09|-0.74|0.12
72394272|NCT01025752|144295450|OTHER||Mean Difference (Final Values)|-0.34||||0.2|TWO_SIDED|95.0|-0.87|0.18|||Mixed Models Analysis|||3 months post-baseline time point. (Mean difference of IVR CBT- F2F CBT)||0.18|-0.87|0.20
72394273|NCT01025752|144295450|OTHER||Mean Difference (Final Values)|-0.02||||0.93|TWO_SIDED|95.0|-0.57|0.52|||Mixed Models Analysis|||6 months post baseline time point. (Mean difference of IVR CBT- F2F CBT)||0.52|-0.57|0.93
72394274|NCT01025752|144295451|OTHER||Mean Difference (Final Values)|-0.5||||0.58|TWO_SIDED|95.0|-2.29|1.29|||Mixed Models Analysis|||post-treatment (12 weeks) time point||1.29|-2.29|0.58
72394275|NCT01025752|144295451|OTHER||Mean Difference (Final Values)|-1.53||||0.12|TWO_SIDED|95.0|-3.46|0.41|||Mixed Models Analysis|||3 months post-baseline time point||0.41|-3.46|0.12
72394276|NCT01025752|144295451|OTHER||Mean Difference (Final Values)|-0.61||||0.51|TWO_SIDED|95.0|-2.42|1.2|||Mixed Models Analysis|||6 months post-baseline time point||1.20|-2.42|0.51
72394277|NCT01025752|144295452|OTHER||Mean Difference (Final Values)|0.29||||0.83|TWO_SIDED|95.0|-2.3|2.87|||Mixed Models Analysis|||post-treatment (12 weeks) time point. (Mean difference of IVR CBT- F2F CBT)||2.87|-2.30|0.83
72394278|NCT01025752|144295452|OTHER||Mean Difference (Final Values)|1.15||||0.42|TWO_SIDED|95.0|-1.68|3.98|||Mixed Models Analysis|||3 months post-baseline time point. (Mean difference of IVR CBT- F2F CBT)||3.98|-1.68|0.42
72394279|NCT01025752|144295452|OTHER||Mean Difference (Final Values)|-0.58||||0.68|TWO_SIDED|95.0|-3.4|2.24|||Mixed Models Analysis|||6 months post-baseline time point. (Mean difference of IVR CBT- F2F CBT)||2.24|-3.40|0.68
72394280|NCT01025752|144295453|OTHER||Mean Difference (Final Values)|1.25||||0.4|TWO_SIDED|95.0|-1.66|4.16|||Mixed Models Analysis|||post-treatment (12 weeks) time point. (Mean difference of IVR CBT- F2F CBT)||4.16|-1.66|0.40
72394281|NCT01025752|144295453|OTHER||Mean Difference (Final Values)|0.38||||0.81|TWO_SIDED|95.0|-2.82|3.58|||Mixed Models Analysis|||3 months post-baseline. (Mean difference of IVR CBT- F2F CBT)||3.58|-2.82|0.81
72465764|NCT00477464|144454544|SUPERIORITY_OR_OTHER||percentage of participants|59.0|||||TWO_SIDED|95.0|44.2|72.4|||||The estimated value represents the percentage of participants who achieved a best overall response of complete response, partial response, or stable disease.|||72.4|44.2|
72394282|NCT01025752|144295453|OTHER||Mean Difference (Final Values)|2.43||||0.16|TWO_SIDED|95.0|-0.96|5.82|||Mixed Models Analysis|||6 months post-baseline time point. (Mean difference of IVR CBT- F2F CBT)||5.82|-0.96|0.16
72394283|NCT01025752|144295454|OTHER||Mean Difference (Final Values)|0.24||||0.85|TWO_SIDED|95.0|-2.32|2.8|||Mixed Models Analysis|||post-treatment (12 weeks time point). (Mean difference of IVR CBT- F2F CBT)||2.80|-2.32|0.85
72394284|NCT01025752|144295454|OTHER||Mean Difference (Final Values)|-1.27||||0.4|TWO_SIDED|95.0|-4.27|1.73|||Mixed Models Analysis|||3 months post-baseline time point. (Mean difference of IVR CBT- F2F CBT)||1.73|-4.27|0.40
72394285|NCT01025752|144295454|OTHER||Mean Difference (Final Values)|-0.74||||0.68|TWO_SIDED|95.0|-4.3|2.83|||Mixed Models Analysis|||6 months post-baseline time point. (Mean difference of IVR CBT- F2F CBT)||2.83|-4.30|0.68
72394286|NCT01025752|144295455|OTHER||Mean Difference (Final Values)|-0.94||||0.17|TWO_SIDED|95.0|-2.28|0.4|||Mixed Models Analysis|||post-treatment (12 weeks) time point. (Mean difference of IVR CBT- F2F CBT)||0.40|-2.28|0.17
72394287|NCT01025752|144295455|OTHER||Mean Difference (Final Values)|-0.12||||0.86|TWO_SIDED|95.0|-1.39|1.16|||Mixed Models Analysis|||3 months post-baseline time point. (Mean difference of IVR CBT- F2F CBT)||1.16|-1.39|0.86
72394288|NCT01025752|144295455|OTHER||Mean Difference (Final Values)|0.37||||0.64|TWO_SIDED|95.0|-1.22|1.97|||Mixed Models Analysis|||6 months post-baseline time point. (Mean difference of IVR CBT- F2F CBT)||1.97|-1.22|0.64
72465765|NCT00863798|144454566|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.86||||0.175|TWO_SIDED|95.0|-0.38|2.1||A Hochberg step-up procedure was used to control for the multiplicity associated with multiple active dose arms.|ANCOVA|||An analysis of covariance (ANCOVA) model with treatment and as a factor and the baseline HAM-D17 total score as a covariate was used to compare DVS SR 10 mg to placebo. The comparison was performed at the 0.05 level overall.||2.10|-0.38|0.175
72465766|NCT00863798|144454566|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.51||||0.421|TWO_SIDED|95.0|-0.73|1.75||A Hochberg step-up procedure was used to control for the multiplicity associated with multiple active dose arms.|ANCOVA|||An analysis of covariance (ANCOVA) model with treatment and as a factor and the baseline HAM-D17 total score as a covariate was used to compare DVS SR 10 mg to placebo. The comparison was performed at the 0.05 level overall.||1.75|-0.73|0.421
72502894|NCT05139030|144536147|SUPERIORITY||Least square mean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.28||0.0184|TWO_SIDED|95.0|-1.1|0.0||Average pain 24-48 hours|ANCOVA|Main effect of treatment, categorical covariate of pooled Investigator site, and continuous covariates of age||||-0.0|-1.1|0.0184
72502895|NCT05139030|144536147|SUPERIORITY||Least square mean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.31||0.0476|TWO_SIDED|95.0|-1.1|0.1||Average pain 48-72 hours|ANCOVA|Main effect of treatment, categorical covariate of pooled Investigator site, and continuous covariates of age||||0.1|-1.1|0.0476
72502896|NCT05139030|144536147|SUPERIORITY||Least square mean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.31||0.0529|TWO_SIDED|95.0|-1.1|0.1||Average pain 72-96 hours|ANCOVA|Main effect of treatment, categorical covariate of pooled Investigator site, and continuous covariates of age||||0.1|-1.1|0.0529
72564296|NCT00483548|144660346|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|-0.06|STANDARD_ERROR_OF_MEAN|0.15||0.7062||95.0|-0.34|0.23|||ANOVA|||Week 4; LOCF; Analysis of variance model with treatment, country, type of mood stabilizer as fixed effects.||0.23|-0.34|0.7062
72564297|NCT00483548|144660346|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|-0.01|STANDARD_ERROR_OF_MEAN|0.15||0.9518||95.0|-0.31|0.29|||ANOVA|||Week 5; LOCF; Analysis of variance model with treatment, country, type of mood stabilizer as fixed effects.||0.29|-0.31|0.9518
72564298|NCT00483548|144660346|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|0.11|STANDARD_ERROR_OF_MEAN|0.16||0.4757||95.0|-0.2|0.42||Analysis of variance model with treatment, country, type of mood stabilizer as fixed effects.|ANOVA|||Week 6; LOCF||0.42|-0.20|0.4757
72564299|NCT00483548|144660347|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|0.35|STANDARD_ERROR_OF_MEAN|0.75||0.6362||95.0|-1.12|1.82|||ANCOVA|||Week 2; LOCF; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.||1.82|-1.12|0.6362
72564300|NCT00483548|144660347|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|0.59|STANDARD_ERROR_OF_MEAN|0.8||0.4565||95.0|-0.98|2.17|||ANCOVA|||Week 4; LOCF; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.||2.17|-0.98|0.4565
72564301|NCT00483548|144660347|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|0.61|STANDARD_ERROR_OF_MEAN|0.86||0.477||95.0|-1.08|2.3|||ANCOVA|||Week 6; LOCF; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.||2.30|-1.08|0.4770
72564302|NCT00483548|144660348|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|0.7|STANDARD_ERROR_OF_MEAN|0.46||0.1277||95.0|-0.2|1.6|||ANCOVA|||Week 1; LOCF; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.||1.60|-0.20|0.1277
72564303|NCT00483548|144660348|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|0.64|STANDARD_ERROR_OF_MEAN|0.53||0.2345||95.0|-0.41|1.68|||ANCOVA|||Week 2; LOCF; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.||1.68|-0.41|0.2345
72564304|NCT00483548|144660348|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|0.13|STANDARD_ERROR_OF_MEAN|0.6||0.8337||95.0|-1.05|1.3|||ANCOVA|||Week 3; LOCF; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.||1.30|-1.05|0.8337
72370641|NCT00488683|144251635|SUPERIORITY_OR_OTHER||R-square|0.21||||||95.0|||||Regression, Linear||Values from Group 1, 2 and 3 were combined for this analysis.|Linear regression coefficient between CRM197 specific memory B cells one month after primary vaccination and CRM197 specific memory B cells at 12 months of age||||
72370642|NCT00488683|144251635|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|-0.15||||0.53||95.0|||||Parametric correlation|||Pearson correlation coefficient between CRM197 specific memory B cells one month after primary vaccination and CRM197 specific memory B cells 1 month after booster vaccination||||0.53
72370643|NCT00488683|144251635|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|0.21||||0.26||95.0|||||Parametric correlation||Values from Groups 1, 2 and 3 were combined for this analysis.|Pearson correlation coefficient between CRM197 specific memory B cells one month after primary vaccination and CRM197 specific memory B cells one month after booster vaccination||||0.26
72370644|NCT00488683|144251635|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|-0.05||||0.84||95.0|||||Non-parametric correlation|||Spearman correlation coefficient between CRM197 specific memory B cells one month after primary vaccination and CRM197 specific memory B cells one month after booster vaccination||||0.84
72370645|NCT00488683|144251635|SUPERIORITY_OR_OTHER||Spearman Correlation Coefficient|0.22||||0.26||95.0|||||Non-parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Spearman correlation coefficient between CRM197 specific memory B cells one month after primary vaccination and CRM197 specific memory B cells one month after booster vaccination||||0.26
72370646|NCT00488683|144251635|SUPERIORITY_OR_OTHER||R-square|0.02||||||95.0|||||Regression, Linear|||Linear regression coefficient between CRM197 specific memory B cells one month after primary vaccination and CRM197 specific memory B cells one month after booster vaccination||||
72370647|NCT00488683|144251635|SUPERIORITY_OR_OTHER||R-square|0.05||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between CRM197 specific memory B cells one month after primary vaccination and CRM197 specific memory B cells one month after booster vaccination||||
72370648|NCT00488683|144251635|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|0.33|||<|0.001||95.0|||||Parametric correlation||Values from Group 1, 2 and 3 were combined for this analysis.|Pearson correlation coefficient between CRM197 specific memory B cells one month after primary vaccination and CRM197 specific IgG concentration at 12 months of age||||<0.001
72370649|NCT00488683|144251635|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.46|||<|0.001||95.0|||||Non-parametric correlation||Values from Group 1, 2 and 3 were combined for this analysis.|Spearman correlation coefficient between CRM197 specific memory B cells one month after primary vaccination and CRM197 specific IgG concentration at 12 months of age||||<0.001
72370650|NCT00488683|144251635|SUPERIORITY_OR_OTHER||R-square|0.11|||<|0.001||95.0|||||Regression, Linear||Values from Group 1, 2 and 3 were combined for this analysis.|Linear regression coefficient between CRM197 specific memory B cells one month after primary vaccination and CRM197 specific IgG concentration at 12 months of age||||<0.001
72621400|NCT02732145|144773193|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of the Urethral Meatus versus non-specific lesions of the Vestibule in patients with impaired vulvar skin?||||||0.0251|||||||t-test proportion|||Parameter: The difference in the incidence of non-specific lesions of the Urethral Meatus versus non-specific lesions of the Vestibule in patients with impaired vulvar skin.||||0.0251
72394289|NCT02850965|144295537|EQUIVALENCE|Protocol defined margins are: \[-18.0%, +18.0%\] for Week 16, 95% confidence interval. Between-imputation variance is zero. Confidence interval is based on one imputed set.|Difference in PASI 75 Response Rate|-2.2|||||TWO_SIDED|95.0|-14.4|8.7|||Regression, Logistic||Difference in PASI 75 Response Rate = (BI 695501 - US-licensed Humira, %).|The week 16 confidence interval for the estimated difference in percentage are produced using the cumulative distribution function method of Reeve.|The statistical model: Logit (response to treatment at Week 16)=Treatment+Baseline PASI+Prior exposure to a biologic agent+random error. Model included fixed, categorical effects of treatment (BI 695501 vs US-licensed Humira) and prior exposure to a biologic agent (yes/no), continuous effect of baseline PASI. The random error was assumed to be binomially distributed.|8.7|-14.4|
72394290|NCT02850965|144295538|OTHER|Missing PASI 75 at Week 24 data were imputed using a combination of non-responder imputation (NRI) and last observed carried forward (LOCF).|Difference in PASI 75 Response Rate|2.9|||||TWO_SIDED|95.0|-8.5|12.6|||Regression, Logistic||Difference in PASI 75 Response Rate = (BI 695501 - US-licensed Humira, %).|The week 24 confidence interval for the estimated difference in percentage are produced using the cumulative distribution function method of Reeve.|The statistical model: Logit (response to treatment at Week 24)=Treatment+Baseline PASI+Prior exposure to a biologic agent+random error. Model included fixed, categorical effects of treatment (BI 695501 vs US-licensed Humira) and prior exposure to a biologic agent (yes/no), continuous effect of baseline PASI. The random error was assumed to be binomially distributed.|12.6|-8.5|
72394291|NCT02850965|144295539|OTHER||Difference of Least Squares Means|1.7|||||TWO_SIDED|95.0|-2.7|6.0|||ANCOVA|Analysis of covariance (ANCOVA)|Difference of Least Squares Means (LSM)= LSM of (BI 695501 - Humira)|Analysis of covariance (ANCOVA) was performed based on the following model: PASI percentage improvement from baseline at Week 16= Treatment + Baseline PASI +Prior exposure to a biologic agent + random error.||6.0|-2.7|
72394292|NCT02850965|144295540|OTHER|Missing sPGA at Week 16 data were imputed using a combination of non-responder imputation (NRI) and last observed carried forward (LOCF).|Difference in sPGA <= 1 Response Rate|7.5|||||TWO_SIDED|95.0|-4.8|19.1|||Regression, Logistic||Difference in sPGA \<= 1 Response Rate = (BI 695501 - US-licensed Humira, %)|The week 16 confidence interval for the estimated difference in percentage are produced using the cumulative distribution function method of Reeve.|The statistical model: Logit (response to treatment at Week 16)=Treatment+Baseline PASI+Prior exposure to a biologic agent+random error. Model included fixed, categorical effects of treatment (BI 695501 vs US-licensed Humira) and prior exposure to a biologic agent (yes/no), continuous effect of baseline PASI.|19.1|-4.8|
72504828|NCT03114969|144540521|SUPERIORITY||Odds Ratio (OR)|2.974||||0.003|TWO_SIDED|95.0|1.461|6.055||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta+\[Relvar Ellipta+LAMA\] as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.|||6.055|1.461|0.003
72394293|NCT02850965|144295541|OTHER|Missing DLQI at Week 16 data were imputed using a combination of non-responder imputation (NRI) and last observed carried forward (LOCF).|Difference in DLQI Response Rate|0.4|||||TWO_SIDED|95.0|-11.7|11.3|||Regression, Logistic||Difference in DLQI (0, 1) Response Rate = (BI 695501 - US-licensed Humira, %)|The week 16 confidence interval for the estimated difference in percentage are produced using the cumulative distribution function method of Reeve.|The statistical model: Logit (response to treatment at Week 16)=Treatment+Baseline PASI+Prior exposure to a biologic agent+random error. Model included fixed, categorical effects of treatment (BI 695501 vs US-licensed Humira) and prior exposure to a biologic agent (yes/no), continuous effect of baseline PASI.|11.3|-11.7|
72394294|NCT02289417|144295543|SUPERIORITY||Stratified Difference|19.2||||0.0142|TWO_SIDED|95.0|3.4|33.6|||Cochran-Mantel-Haenszel|Stratification was based on baseline use of oral (PO) corticosteroids and previously used immunosuppressants (yes/no).|Stratified difference in percentages is the weighted average of the treatment differences across the strata with the CMH weights, with 2-sided 95% CI based on the stratified Newcombe method.|||33.6|3.4|0.0142
72394295|NCT02289417|144295543|SUPERIORITY||Stratified Difference|7.7||||0.2689|TWO_SIDED|95.0|-6.9|22.0|||Cochran-Mantel-Haenszel|Stratification was based on baseline use of PO corticosteroids and previously used immunosuppressants (yes/no).|Stratified difference in percentages is the weighted average of the treatment differences across the strata with the CMH weights, with 2-sided 95% CI based on the stratified Newcombe method|||22.0|-6.9|0.2689
72394296|NCT02289417|144295544|SUPERIORITY||Stratified Difference|14.6||||0.1224|TWO_SIDED|95.0|-3.6|31.5|||Cochran-Mantel-Haenszel|Stratification was based on baseline use of PO corticosteroids and previously used immunosuppressants (yes/no).|Stratified difference in percentages is the weighted average of the treatment differences across the strata with the CMH weights, with 2-sided 95% CI based on the stratified Newcombe method.|||31.5|-3.6|0.1224
72394297|NCT02289417|144295544|SUPERIORITY||Stratified Difference|19.4||||0.0401|TWO_SIDED|95.0|1.1|36.0|||Cochran-Mantel-Haenszel|Stratification was based on baseline use of PO corticosteroids and previously used immunosuppressants (yes/no).|Stratified difference in percentages is the weighted average of the treatment differences across the strata with the CMH weights, with 2-sided 95% CI based on the stratified Newcombe method.|||36.0|1.1|0.0401
72621401|NCT02732145|144773193|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of Hymenal Remnants versus non-specific lesions of the Vestibule in patients with impaired vulvar skin?||||||0.0006|||||||t-test proportion|||Parameter: The difference in the incidence of non-specific lesions of Hymenal Remnants versus non-specific lesions of the Vestibule in patients with impaired vulvar skin.||||0.0006
72621402|NCT02732145|144773193|SUPERIORITY|Question: Is there a difference in the incidence of specific lesions of the Clitoris versus specific lesions of Hart's Line in patients with vulvar dermatosis?||||||0.0211|||||||t-test proportion|||Parameter: The difference in the incidence of specific lesions of the Clitoris versus specific lesions of Hart's Line in patients with vulvar dermatosis.||||0.0211
72465767|NCT00863798|144454567|SUPERIORITY_OR_OTHER|||||||0.076|TWO_SIDED|||||In this case, multiplicity arising from testing key secondary hypotheses in both doses was controlled by a Hochberg step-up procedure. p-Value obtained for the alternative hypothesis of 'Row mean scores differences'.|Cochran-Mantel-Haenszel|||Each DVS SR dose was separately compared to placebo. To control the study-wise type I error rate across the primary and the key secondary endpoints, as well as across the 2 active dose arms, testing of the key secondary hypothesis occurred only when both active doses were superior to placebo on the primary endpoint.||||0.076
72502897|NCT03772327|144536161|SUPERIORITY||Mean Difference (Net)|0.333||||0.07|TWO_SIDED|95.0|-0.028|0.694|||t-test, 2 sided|A ratio of Week 12 to baseline TFV-DP levels was used rather than a raw difference as a ratio was normally distributed.|The mean difference is mean ratio (Week 12 TFV-DP level over the Week 0 TFV-DP level) in the Routine counseling + AdhereTech bottle arm less the mean ratio in the Routine counseling arm.|The power calculation was based on a null hypothesis of no difference in mean tenofovir-diphosphate (TFV-DP) concentrations between baseline versus week 12. Expected baseline mean (SD): 900 (404) fmol/punch. 12 week mean (SD): 1332 (597) fmol/punch in the AdhereTech bottle arm vs. 900 (404) fmol/punch in control arm. Type 1 error = 0.05, power = 80%, a sample size of 32 per arm (64 total) based on a two-sided t-test with equal variance.||0.694|-0.028|0.070
72370651|NCT00488683|144251635|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|0.24||||0.06||95.0|||||Parametric correlation|||Pearson correlation coefficient between CRM197 specific memory B cells one month after primary vaccination and CRM197 specific IgG concentration one month after booster vaccination||||0.06
72370652|NCT00488683|144251635|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|0.5|||<|0.001||95.0|||||Parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Pearson correlation coefficient between CRM197 specific memory B cells one month after primary vaccination and CRM197 specific IgG concentration one month after booster vaccination||||<0.001
72502898|NCT03772327|144536162|EQUIVALENCE|Equivalence defined if a two-sided 2 sample proportion test accepts the null hypothesis with p \> 0.05.|Difference in proportions|0.045||||0.89|TWO_SIDED|95.0|-0.179|0.27|||Chi-squared, Corrected|degrees of freedom = 1|This is the proportion of those completing a week 12 visit less those completing a week 0 visit.|The null hypothesis is that the proportion of randomized participants that complete a week 12 visit is not lower in the AdhereTech bottle arm.||0.270|-0.179|0.89
72502899|NCT03772327|144536163|SUPERIORITY||Median Difference (Net)|-0.07||||0.328|TWO_SIDED||||||Kruskal-Wallis|Log transformation of viral load|Difference of log viral load at Week 12 less the log viral load at baseline|Null hypothesis: Mean HIV viral load is not significantly different in the AdhereTech bottle group compared to the routine counseling only group.||||0.328
72502900|NCT03772327|144536164|SUPERIORITY||Odds Ratio (OR)|0.395||||0.294|TWO_SIDED|95.0|0.058|2.044|||Fisher Exact||Odds ratio for change from HIV RNA ≥ 20 copies/mL at baseline to HIV RNA \< 20 copies/mL at week 12 due to the intervention (AdhereTech bottle).|Null hypothesis: There is no difference in proportion of participants that go from HIV RNA ≥ 20 copies/mL to HIV RNA \< 20 copies/mL between baseline to Week 12 in the AdhereTech bottle group compared the routine counseling group.||2.044|0.058|0.294
72502901|NCT03772327|144536166|SUPERIORITY||Difference in proportions|0.019||||1|TWO_SIDED|95.0|-0.237|0.276|||Chi-squared, Corrected|||Null hypothesis: Adherence in the AdhereTech bottle arm is not better than the control arm at Week 12.||0.276|-0.237|1
72502902|NCT04233424|144536167|SUPERIORITY||Risk Ratio (RR)|-2.8||||0.152|TWO_SIDED|95.0|-6.7|1.0|||Cochran-Mantel-Haenszel|||||1.0|-6.7|0.152
72502903|NCT04233424|144536168|SUPERIORITY||Risk Ratio (RR)|-0.8||||0.6219|TWO_SIDED|95.0|-3.9|2.3|||Cochran-Mantel-Haenszel|||||2.3|-3.9|0.6219
72502904|NCT04233424|144536169|SUPERIORITY||Risk Ratio (RR)|-0.8||||0.4373|TWO_SIDED|95.0|-2.8|1.2|||Kaplan-Meier Analysis|||||1.2|-2.8|0.4373
72502905|NCT01254344|144536172|NON_INFERIORITY_OR_EQUIVALENCE|"Assuming a 70% rate (i.e., proportion of participants with success of prophylaxis) for both groups and a significance level of 0.025, at least 200 evaluable participants per group were needed to have 90% probability that the lower limit of the 95% (two-sided) confidence interval for the difference in the response rates between the 2 groups was greater than -15 percentage points."|Difference in percentage of prophylaxis|0.1|||||TWO_SIDED|95.0|-5.2|5.5|||Miettinen and Nurminen|||||5.5|-5.2|
72370653|NCT00488683|144251635|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.31||||0.01||95.0|||||Non-parametric correlation|||Spearman correlation coefficient between CRM197 specific memory B cells one month after primary vaccination and CRM197 specific IgG concentration one month after booster vaccination||||0.01
72502906|NCT01254344|144536173|SUPERIORITY_OR_OTHER||Difference in percentage of prophylaxis|1.3|||||TWO_SIDED|95.0|-2.2|5.1|||Miettinen and Nurminen|||||5.1|-2.2|
72370654|NCT00488683|144251635|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.2||||0.1||95.0|||||Non-parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Spearman correlation coefficient between CRM197 specific memory B cells one month after primary vaccination and CRM197 specific IgG concentration one month after booster vaccination||||0.10
72370655|NCT00488683|144251635|SUPERIORITY_OR_OTHER||R-square|0.06||||||95.0|||||Regression, Linear|||Linear regression coefficient between CRM197 specific memory B cells one month after primary vaccination and CRM197 specific IgG concentration one month after booster vaccination||||
72370656|NCT00488683|144251635|SUPERIORITY_OR_OTHER||R-square|0.25||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between CRM197 specific memory B cells one month after primary vaccination and CRM197 specific IgG concentration one month after booster vaccination||||
72370657|NCT00488683|144251641|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|0.04||||0.7||95.0|||||Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration at day 1 in the serum of mother for the serogroup A||||0.70
72621403|NCT02732145|144773193|SUPERIORITY|Question: Is there a difference in the incidence of specific lesions of the Clitoris versus specific lesions of the Urethral Sulcus in patients with vulvar dermatosis?||||||0.3067|||||||t-test proportion|||Parameter: The difference in the incidence of specific lesions of the Clitoris versus specific lesions of the Urethral Sulcus in patients with vulvar dermatosis.||||0.3067
72621404|NCT02732145|144773193|SUPERIORITY|Question: Is there a difference in the incidence of specific lesions of the Clitoris versus specific lesions of the Urethral Meatus in patients with vulvar dermatosis?||||||0.0295|||||||t-test proportion|||Parameter: The difference in the incidence of specific lesions of the Clitoris versus specific lesions of the Urethral Meatus in patients with vulvar dermatosis.||||0.0295
72621405|NCT02732145|144773193|SUPERIORITY|Question: Is there a difference in the incidence of specific lesions of the Clitoris versus specific lesions of Hymenal Remnants in patients with vulvar dermatosis?||||||0.0149|||||||t-test proportion|||Parameter: The difference in the incidence of specific lesions of the Clitoris versus specific lesions of Hymenal Remnants in patients with vulvar dermatosis.||||0.0149
72621406|NCT02732145|144773193|SUPERIORITY|Question: Is there a difference in the incidence of specific lesions of the Clitoris versus specific lesions of Bartholin's Gland Opening in patients with vulvar dermatosis?||||||0.0007|||||||t-test proportion|||Parameter: The difference in the incidence of specific lesions of the Clitoris versus specific lesions of Bartholin's Gland Opening in patients with vulvar dermatosis.||||0.0007
72621407|NCT02732145|144773193|SUPERIORITY|Question: Is there a difference in the incidence of specific lesions of the Clitoris versus specific lesions of the Vestibule in patients with vulvar dermatosis?||||||0.0295|||||||t-test proportion|||Parameter: The difference in the incidence of specific lesions of the Clitoris versus specific lesions of the Vestibule in patients with vulvar dermatosis.||||0.0295
72621408|NCT02732145|144773194|EQUIVALENCE|Question: Is there a difference in the incidence of aceto-whitening between patients from different groups, with positive AWR?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of aceto-whitening between patients from different groups, with positive AWR.||||0.0000
72502907|NCT01982630|144536187|OTHER||Difference of Least Squares Means|-0.23|||||TWO_SIDED|90.0|-4.59|4.13|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline TWA0-24hr of heart rate as a covariate||||4.13|-4.59|
72502908|NCT01982630|144536187|OTHER||Difference of Least Squares Means|-6.25|||||TWO_SIDED|90.0|-10.48|-2.01|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline TWA0-24hr of heart rate as a covariate||||-2.01|-10.48|
72621409|NCT02732145|144773194|EQUIVALENCE|Question: Is there a difference in the incidence of coarse AWR between patients from different groups and positive AWR?||||||0.0071|||||||Chi-squared|||Parameter: The difference in the incidence of coarse AWR between patients from different groups and positive AWR.||||0.0071
72621410|NCT02732145|144773194|EQUIVALENCE|Question: Is there a difference in the incidence of slow AWR between patients from different groups and positive AWR?||||||0.001|||||||Chi-squared|||Parameter: The difference in the incidence of slow AWR occurrence between patients from different groups and positive AWR.||||0.0010
72621411|NCT02732145|144773194|EQUIVALENCE|Question: Is there a difference in the incidence of provoked erythema among patients from different groups and positive AWR?||||||0.0036|||||||Chi-squared|||Parameter: The difference in the incidence of provoked erythema among patients from different groups and positive AWR.||||0.0036
72621412|NCT02732145|144773194|EQUIVALENCE|Question: Is there a difference in the incidence of sharply bordered AWR between patients from different groups and positive AWR?||||||0.0032|||||||Chi-squared|||Parameter: The difference in the incidence of sharply bordered AWR between patients from different groups and positive AWR.||||0.0032
72621413|NCT02732145|144773194|EQUIVALENCE|Question: Is there a difference in the incidence of aceto-whitening of Outer Vulvar Ring between the patients from different groups and positive AWR?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of aceto-whitening of Outer Vulvar Ring between the patients from different groups and positive AWR.||||0.0000
72370658|NCT00488683|144251641|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|-0.04||||0.63||95.0|||||Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration at day 1 in the serum of mother for the serogroup C||||0.63
72370659|NCT00488683|144251641|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|-0.03||||0.74||95.0|||||Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration at day 1 in the serum of mother for the serogroup W-135||||0.74
72502909|NCT01982630|144536187|OTHER||Difference of Least Squares Means|6.02|||||TWO_SIDED|90.0|1.81|10.22|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline TWA0-24hr of heart rate as a covariate||||10.22|1.81|
72502910|NCT01982630|144536187|OTHER||Difference of Least Squares Means|1.5|||||TWO_SIDED|90.0|-2.65|5.64|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline TWA0-24hr of heart rate as a covariate||||5.64|-2.65|
72502911|NCT01982630|144536187|OTHER||Difference of Least Squares Means|-4.52|||||TWO_SIDED|90.0|-8.52|-0.52|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline TWA0-24hr of heart rate as a covariate||||-0.52|-8.52|
72502912|NCT01982630|144536187|OTHER||Difference of Least Squares Means|1.73|||||TWO_SIDED|90.0|-2.38|5.83|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline TWA0-24hr of heart rate as a covariate||||5.83|-2.38|
72502913|NCT01982630|144536188|OTHER||Difference of Least Squares Means|-2.11|||||TWO_SIDED|90.0|-4.55|0.32|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline TWA0-24hr of heart rate as a covariate||||0.32|-4.55|
72502914|NCT01982630|144536188|OTHER||Difference of Least Squares Means|2.53|||||TWO_SIDED|90.0|-0.61|5.66|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline TWA0-24hr of heart rate as a covariate||||5.66|-0.61|
72502915|NCT01982630|144536188|OTHER||Difference of Least Squares Means|4.64|||||TWO_SIDED|90.0|1.35|7.93|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline TWA0-24hr of heart rate as a covariate||||7.93|1.35|
72465768|NCT00863798|144454567|SUPERIORITY_OR_OTHER|||||||0.204|TWO_SIDED|||||In this case, multiplicity arising from testing key secondary hypotheses in both doses was controlled by a Hochberg step-up procedure. p-Value obtained for the alternative hypothesis of 'Row mean scores differences'.|Cochran-Mantel-Haenszel|||Each DVS SR dose was separately compared to placebo. To control the study-wise type I error rate across the primary and the key secondary endpoints, as well as across the 2 active dose arms, testing of the key secondary hypothesis occurred only when both active doses were superior to placebo on the primary endpoint.||||0.204
72465769|NCT00863798|144454568|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.15||||0.13|TWO_SIDED|95.0|-0.04|0.35|||ANCOVA|||Analysis was conducted using ANCOVA on the change from baseline with treatment as a factor and corresponding baseline value as a covariate.||0.35|-0.04|0.130
72502916|NCT01982630|144536189|OTHER||Difference of Least Squares Means|-0.65|||||TWO_SIDED|90.0|-5.01|3.71|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline TWA0-24hr of heart rate as a covariate||||3.71|-5.01|
72502917|NCT01982630|144536189|OTHER||Difference of Least Squares Means|-6.42|||||TWO_SIDED|90.0|-10.66|-2.19|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline TWA0-24hr of heart rate as a covariate||||-2.19|-10.66|
72394298|NCT02289417|144295545|SUPERIORITY||Stratified Difference|5.2||||0.2472|TWO_SIDED|95.0|-5.7|16.7|||Cochran-Mantel-Haenszel|Stratification was based on baseline use of PO corticosteroids and previously used immunosuppressants (yes/no).|Stratified difference in percentages is the weighted average of the treatment differences across the strata with the CMH weights, with 2-sided 95% CI based on the stratified Newcombe method.|||16.7|-5.7|0.2472
72465770|NCT00863798|144454568|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.03||||0.757|TWO_SIDED|95.0|-0.16|0.23|||ANCOVA|||Analysis was conducted using ANCOVA on the change from baseline with treatment as a factor and corresponding baseline value as a covariate.||0.23|-0.16|0.757
72465771|NCT00863798|144454569|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|1.41||||0.114|TWO_SIDED|95.0|-0.34|3.16|||ANCOVA|||Analysis was conducted using ANCOVA on the change from baseline with treatment as a factor and corresponding baseline value as a covariate.||3.16|-0.34|0.114
72502918|NCT01982630|144536189|OTHER||Difference of Least Squares Means|5.77|||||TWO_SIDED|90.0|1.57|9.97|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline TWA0-24hr of heart rate as a covariate||||9.97|1.57|
72621414|NCT02732145|144773194|EQUIVALENCE|Question: Is there a difference in the incidence of aceto-whitening of Middle Vulvar Ring between the patients from different groups and positive AWR?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of aceto-whitening of Middle Vulvar Ring between the patients from different groups and positive AWR.||||0.0000
72621415|NCT02732145|144773194|EQUIVALENCE|Question: Is there a difference in the incidence of aceto-whitening of Inner Vulvar Ring between the patients from different groups and positive AWR?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of aceto-whitening of Inner Vulvar Ring between the patients from different groups and positive AWR.||||0.0000
72465772|NCT00863798|144454569|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.89||||0.316|TWO_SIDED|95.0|-0.85|2.64|||ANCOVA|||Analysis was conducted using ANCOVA on the change from baseline with treatment as a factor and corresponding baseline value as a covariate.||2.64|-0.85|0.316
72465773|NCT00863798|144454570|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.74||||0.054|TWO_SIDED|95.0|-0.01|1.5|||ANCOVA|||Analysis was conducted using ANCOVA on the change from baseline with treatment as a factor and corresponding baseline value as a covariate.||1.50|-0.01|0.054
72465774|NCT00863798|144454570|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.44||||0.253|TWO_SIDED|95.0|-0.32|1.2|||ANCOVA|||Analysis was conducted using ANCOVA on the change from baseline with treatment as a factor and corresponding baseline value as a covariate.||1.20|-0.32|0.253
72465775|NCT00863798|144454571|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.254||||0.2415|TWO_SIDED|95.0|0.86|1.83|||Regression, Logistic|||Analysis was conducted using a logistic regression model with treatment as a factor and baseline HAM-D17 score as a covariate.||1.83|0.86|0.2415
72465776|NCT00863798|144454571|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.102||||0.6169|TWO_SIDED|95.0|0.75|1.61|||Regression, Logistic|||Analysis was conducted using a logistic regression model with treatment as a factor and baseline HAM-D17 score as a covariate.||1.61|0.75|0.6169
72465777|NCT00863798|144454572|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.236||||0.3667|TWO_SIDED|95.0|0.78|1.96|||Regression, Logistic|||Analysis was conducted using a logistic regression model with treatment as a factor and baseline HAM-D17 score as a covariate.||1.96|0.78|0.3667
72394299|NCT02289417|144295545|SUPERIORITY||Stratified Difference|3.1||||0.4628|TWO_SIDED|95.0|-7.5|14.6|||Cochran-Mantel-Haenszel|Stratification was based on baseline use of PO corticosteroids and previously used immunosuppressants (yes/no).|Stratified difference in percentages is the weighted average of the treatment differences across the strata with the CMH weights, with 2-sided 95% CI based on the stratified Newcombe method.|||14.6|-7.5|0.4628
72394300|NCT02289417|144295546|SUPERIORITY||Stratified Difference|32.0||||0.0005|TWO_SIDED|95.0|13.8|47.4|||Cochran-Mantel-Haenszel|Stratification was based on baseline use of PO corticosteroids and previously used immunosuppressants (yes/no).|Stratified difference in percentages is the weighted average of the treatment differences across the strata with the CMH weights, with 2-sided 95% CI based on the stratified Newcombe method.|||47.4|13.8|0.0005
72394301|NCT02289417|144295546|SUPERIORITY||Stratified Difference|3.7||||0.6878|TWO_SIDED|95.0|-14.4|21.5|||Cochran-Mantel-Haenszel|Stratification was based on baseline use of PO corticosteroids and previously used immunosuppressants (yes/no).|Stratified difference in percentages is the weighted average of the treatment differences across the strata with the CMH weights, with 2-sided 95% CI based on the stratified Newcombe method.|||21.5|-14.4|0.6878
72394302|NCT02289417|144295547|SUPERIORITY||Stratified Difference|11.5||||0.1388|TWO_SIDED|95.0|-4.1|26.1|||Cochran-Mantel-Haenszel|Stratification was based on baseline use of PO corticosteroids and previously used immunosuppressants (yes/no).|Stratified difference in percentages is the weighted average of the treatment differences across the strata with the CMH weights, with 2-sided 95% CI based on the stratified Newcombe method.|||26.1|-4.1|0.1388
72394303|NCT02289417|144295547|SUPERIORITY||Stratified Difference|13.5||||0.0788|TWO_SIDED|95.0|-1.6|27.7||Stratification was based on baseline use of PO corticosteroids and previously used immunosuppressants (yes/no).|Cochran-Mantel-Haenszel||Stratified difference in percentages is the weighted average of the treatment differences across the strata with the CMH weights, with 2-sided 95% CI based on the stratified Newcombe method.|||27.7|-1.6|0.0788
72394304|NCT02289417|144295548|SUPERIORITY||Stratified Difference|24.8||||0.0046|TWO_SIDED|95.0|7.5|40.1|||Cochran-Mantel-Haenszel|Stratification was based on baseline use of PO corticosteroids and previously used immunosuppressants (yes/no).|Stratified difference in percentages is the weighted average of the treatment differences across the strata with the CMH weights, with 2-sided 95% CI based on the stratified Newcombe method.|||40.1|7.5|0.0046
72394305|NCT02289417|144295548|SUPERIORITY||Stratified Difference|6.0||||0.4476||95.0|-9.8|21.6|||Cochran-Mantel-Haenszel|Stratification was based on baseline use of PO corticosteroids and previously used immunosuppressants (yes/no).|Stratified difference in percentages is the weighted average of the treatment differences across the strata with the CMH weights, with 2-sided 95% CI based on the stratified Newcombe method.|||21.6|-9.8|0.4476
72394306|NCT02289417|144295549|SUPERIORITY||Stratified Difference|16.7||||0.0755|TWO_SIDED|95.0|-1.4|33.5|||Cochran-Mantel-Haenszel|Stratification was based on baseline use of PO corticosteroids and previously used immunosuppressants (yes/no).|Stratified difference in percentages is the weighted average of the treatment differences across the strata with the CMH weights, with 2-sided 95% CI based on the stratified Newcombe method.|||33.5|-1.4|0.0755
72394307|NCT02289417|144295549|SUPERIORITY||Stratified Difference|19.8||||0.037|TWO_SIDED|95.0|1.5|36.4|||Cochran-Mantel-Haenszel|Stratification was based on baseline use of PO corticosteroids and previously used immunosuppressants (yes/no).|Stratified difference in percentages is the weighted average of the treatment differences across the strata with the CMH weights, with 2-sided 95% CI based on the stratified Newcombe method.|||36.4|1.5|0.0370
72394308|NCT02289417|144295550|SUPERIORITY||Stratified Difference|14.6||||0.1167|TWO_SIDED|95.0|-3.3|31.4|||Cochran-Mantel-Haenszel|Stratification was based on baseline use of PO corticosteroids and previously used immunosuppressants (yes/no).|Stratified difference in percentages is the weighted average of the treatment differences across the strata with the CMH weights, with 2-sided 95% CI based on the stratified Newcombe method.|||31.4|-3.3|0.1167
72394309|NCT02289417|144295550|SUPERIORITY||Stratified Difference|18.1||||0.0534|TWO_SIDED|95.0|-0.3|34.9|||Cochran-Mantel-Haenszel|Stratification was based on baseline use of PO corticosteroids and previously used immunosuppressants (yes/no).|Stratified difference in percentages is the weighted average of the treatment differences across the strata with the CMH weights, with 2-sided 95% CI based on the stratified Newcombe method.|||34.9|-0.3|0.0534
72394310|NCT02289417|144295551|SUPERIORITY||Stratified Difference|16.6||||0.0758|TWO_SIDED|95.0|-1.5|33.3|||Cochran-Mantel-Haenszel|Stratification was based on baseline use of PO corticosteroids and previously used immunosuppressants (yes/no).|Stratified difference in percentages is the weighted average of the treatment differences across the strata with the CMH weights, with 2-sided 95% CI based on the stratified Newcombe method.|||33.3|-1.5|0.0758
72394311|NCT02289417|144295551|SUPERIORITY||Stratified Difference|32.5||||0.0004|TWO_SIDED|95.0|14.9|47.5|||Cochran-Mantel-Haenszel|Stratification was based on baseline use of PO corticosteroids and previously used immunosuppressants (yes/no).|Stratified difference in percentages is the weighted average of the treatment differences across the strata with the CMH weights, with 2-sided 95% CI based on the stratified Newcombe method.|||47.5|14.9|0.0004
72394312|NCT04786990|144295558|OTHER||||||<|0.0001||||||The p-value generated from the statistical test for this efficacy measure is considered nominal. An adjustment for multiplicity was not performed, and as a result, there is no control of Type 1 error in the statistical analysis of these data.|t-test, 2 sided|||Week 4||||<0.0001
72465778|NCT00863798|144454572|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.894||||0.6509|TWO_SIDED|95.0|0.55|1.45|||Regression, Logistic|||Analysis was conducted using a logistic regression model with treatment as a factor and baseline HAM-D17 score as a covariate.||1.45|0.55|0.6509
72465779|NCT00863798|144454573|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.182||||0.3893|TWO_SIDED|95.0|0.81|1.73|||Regression, Logistic|||Analysis would be conducted with a logistic regression model with treatment as a factor and baseline MADRS score as a covariate.||1.73|0.81|0.3893
72465780|NCT00863798|144454573|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.123||||0.551|TWO_SIDED|95.0|0.77|1.65|||Regression, Logistic|||Analysis would be conducted with a logistic regression model with treatment as a factor and baseline MADRS score as a covariate.||1.65|0.77|0.5510
72564305|NCT00483548|144660348|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|0.43|STANDARD_ERROR_OF_MEAN|0.59||0.4646||95.0|-0.73|1.59|||ANCOVA|||Week 4; LOCF; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.||1.59|-0.73|0.4646
72564306|NCT00483548|144660348|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|0.5|STANDARD_ERROR_OF_MEAN|0.59||0.3993||95.0|-0.67|1.67|||ANCOVA|||Week 5; LOCF; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.||1.67|-0.67|0.3993
72564307|NCT00483548|144660348|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|0.19|STANDARD_ERROR_OF_MEAN|0.65||0.7647||95.0|-1.08|1.46|||ANCOVA|||Week 6; LOCF; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.||1.46|-1.08|0.7647
72564308|NCT00483548|144660349|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|4.24|STANDARD_ERROR_OF_MEAN|1.65||0.0108||95.0|0.99|7.5|||ANCOVA|||Week 6; Observed cases; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.||7.50|0.99|0.0108
72564309|NCT00483548|144660350|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|-4.56|STANDARD_ERROR_OF_MEAN|1.35||0.001||95.0|-7.24|-1.87|||ANCOVA|||Total SDS: Week 6; Observed cases; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.||-1.87|-7.24|0.0010
72564310|NCT00483548|144660351|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|-0.44|STANDARD_ERROR_OF_MEAN|0.28||0.123|TWO_SIDED|95.0|-1.0|0.12|||ANCOVA|||Days Lost: Week 6; Observed cases; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.||0.12|-1.00|0.1230
72564311|NCT00483548|144660351|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|-0.17|STANDARD_ERROR_OF_MEAN|0.34||0.6232|TWO_SIDED|95.0|-0.84|0.5|||ANCOVA|||Days Unproductive: Week 6; Observed cases; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.||0.50|-0.84|0.6232
72564312|NCT00483548|144660352|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|0.17|STANDARD_ERROR_OF_MEAN|0.07||0.0096||95.0|0.04|0.31|||ANCOVA|||Week 2; Observed cases; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.||0.31|0.04|0.0096
72564313|NCT00483548|144660352|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|0.02|STANDARD_ERROR_OF_MEAN|0.07||0.8134||95.0|-0.13|0.16|||ANCOVA|||Week 4; Observed cases; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.||0.16|-0.13|0.8134
72564314|NCT00483548|144660352|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|0.16|STANDARD_ERROR_OF_MEAN|0.07||0.0226||95.0|0.02|0.29|||ANCOVA|||Week 6; Observed cases; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.||0.29|0.02|0.0226
72564315|NCT00483548|144660353|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|0.12|STANDARD_ERROR_OF_MEAN|0.05||0.0193||95.0|0.02|0.23|||ANCOVA|||Week 2; Observed cases; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.||0.23|0.02|0.0193
72564316|NCT00483548|144660353|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|0.04|STANDARD_ERROR_OF_MEAN|0.06||0.4745||0.16|-0.07|0.16|||ANCOVA|||Week 4; Observed cases; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.||0.16|-0.07|0.4745
72564317|NCT00483548|144660353|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|0.07|STANDARD_ERROR_OF_MEAN|0.06||0.2613||95.0|-0.05|0.19|||ANCOVA|||Week 6; Observed cases; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.||0.19|-0.05|0.2613
72564318|NCT00483548|144660354|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|0.11|STANDARD_ERROR_OF_MEAN|0.05||0.0271||95.0|0.01|0.21|||ANCOVA|||Total score: Week 2; Observed cases; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.||0.21|0.01|0.0271
72564319|NCT00483548|144660354|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|-0.01|STANDARD_ERROR_OF_MEAN|0.03||0.7462||95.0|-0.07|0.05|||ANCOVA|||Total score: Week 4; Observed cases; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.||0.05|-0.07|0.7462
72564320|NCT00483548|144660354|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|0.0|STANDARD_ERROR_OF_MEAN|0.04||0.9574||95.0|-0.08|0.08|||ANCOVA|||Total score: Week 6; Observed cases; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.||0.08|-0.08|0.9574
72564321|NCT00483548|144660354|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|0.05|STANDARD_ERROR_OF_MEAN|0.03||0.0844||95.0|-0.01|0.1|||ANCOVA|||Global severity score: Week 2; Observed cases; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.||0.10|-0.01|0.0844
72564322|NCT00483548|144660354|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|0.01|STANDARD_ERROR_OF_MEAN|0.02||0.5779||95.0|-0.04|0.06|||ANCOVA|||Global severity score: Week 4; Observed cases; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.||0.06|-0.04|0.5779
72465781|NCT00863798|144454574|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.442||||0.0536|TWO_SIDED|95.0|0.99|2.09|||Regression, Logistic|||Analysis would be conducted with a logistic regression model with treatment as a factor.||2.09|0.99|0.0536
72465782|NCT00863798|144454574|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.085||||0.6679|TWO_SIDED|95.0|0.75|1.57|||Regression, Logistic|||Analysis would be conducted with a logistic regression model with treatment as a factor.||1.57|0.75|0.6679
72465783|NCT00863798|144454576|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.46||||0.033|TWO_SIDED|95.0|0.12|2.79|||ANCOVA|||"Analysis was conducted using ANCOVA on the change from baseline with treatment as a factor and corresponding baseline value as a covariate for total score."||2.79|0.12|0.033
72465784|NCT00863798|144454576|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.15||||0.096|TWO_SIDED|95.0|-0.2|2.49|||ANCOVA|||"Analysis was conducted using ANCOVA on the change from baseline with treatment as a factor and corresponding baseline value as a covariate for total score."||2.49|-0.20|0.096
72465785|NCT00863798|144454576|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.48||||0.043|TWO_SIDED|95.0|0.02|0.95|||ANCOVA|||"Analysis was conducted using ANCOVA on the change from baseline with treatment as a factor and corresponding baseline value as a covariate for work/studies component score."||0.95|0.02|0.043
72502919|NCT01982630|144536189|OTHER||Difference of Least Squares Means|-0.15|||||TWO_SIDED|90.0|-4.29|4.0|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline TWA0-24hr of heart rate as a covariate||||4.00|-4.29|
72502920|NCT01982630|144536189|OTHER||Difference of Least Squares Means|-5.91|||||TWO_SIDED|90.0|-9.91|-1.92|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline TWA0-24hr of heart rate as a covariate||||-1.92|-9.91|
72502921|NCT01982630|144536189|OTHER||Difference of Least Squares Means|0.51|||||TWO_SIDED|90.0|-3.6|4.62|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline TWA0-24hr of heart rate as a covariate||||4.62|-3.60|
72502922|NCT01982630|144536190|OTHER||Difference of Least Squares Means|-0.89|||||TWO_SIDED|90.0|-3.8|2.02|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline TWA0-24hr of heart rate as a covariate||||2.02|-3.80|
72502923|NCT01982630|144536190|OTHER||Difference of Least Squares Means|5.24|||||TWO_SIDED|90.0|1.34|9.15|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline TWA0-24hr of heart rate as a covariate||||9.15|1.34|
72502924|NCT01982630|144536190|OTHER||Difference of Least Squares Means|6.13|||||TWO_SIDED|90.0|2.05|10.22|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline TWA0-24hr of heart rate as a covariate||||10.22|2.05|
72502925|NCT01982630|144536191|OTHER||Difference of Least Squares Means|-0.57|||||TWO_SIDED|90.0|-3.71|2.57|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline TWA0-24hr of heart rate as a covariate||||2.57|-3.71|
72502926|NCT01982630|144536191|OTHER||Difference of Least Squares Means|7.77|||||TWO_SIDED|90.0|3.5|12.03|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline TWA0-24hr of heart rate as a covariate||||12.03|3.50|
72502927|NCT01982630|144536191|OTHER||Difference of Least Squares Means|8.34|||||TWO_SIDED|90.0|3.89|12.79|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline TWA0-24hr of heart rate as a covariate||||12.79|3.89|
72502928|NCT01982630|144536192|OTHER||Difference of Least Squares Means|1.35|||||TWO_SIDED|90.0|-2.4|5.09|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline TWA0-24hr of heart rate as a covariate||||5.09|-2.40|
72502929|NCT01982630|144536192|OTHER||Difference of Least Squares Means|8.29|||||TWO_SIDED|90.0|3.29|13.3|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline TWA0-24hr of heart rate as a covariate||||13.30|3.29|
72502930|NCT01982630|144536192|OTHER||Difference of Least Squares Means|6.95|||||TWO_SIDED|90.0|1.69|12.2|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline TWA0-24hr of heart rate as a covariate||||12.20|1.69|
72502931|NCT01982630|144536193|OTHER||Difference of Least Squares Means|2.46|||||TWO_SIDED|90.0|-1.42|6.34|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline TWA0-24hr of heart rate as a covariate||||6.34|-1.42|
72370660|NCT00488683|144251641|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|-0.03||||0.74||95.0|||||Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration at day 1 in the serum of mother for the serogroup Y||||0.74
72370661|NCT00488683|144251641|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.18||||0.05||95.0|||||Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration at day 1 in the serum of mother for the serogroup A||||0.05
72370662|NCT00488683|144251641|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|-0.07||||0.36||95.0|||||Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration at day 1 in the serum of mother for the serogroup C||||0.36
72370663|NCT00488683|144251641|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|-0.11||||0.18||95.0|||||Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration at day 1 in the serum of mother for the serogroup W-135||||0.18
72370664|NCT00488683|144251641|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.02||||0.82||95.0|||||Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration at day 1 in the serum of mother for the serogroup Y||||0.82
72370665|NCT00488683|144251641|SUPERIORITY_OR_OTHER||R-square|0.0013||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration at day 1 in the serum of mother for the serogroup A||||
72370666|NCT00488683|144251641|SUPERIORITY_OR_OTHER||R-square|0.0014||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration at day 1 in the serum of mother for the serogroup C||||
72370667|NCT00488683|144251641|SUPERIORITY_OR_OTHER||R-square|0.0008||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration at day 1 in the serum of mother for the serogroup W-135||||
72621416|NCT02732145|144773194|EQUIVALENCE|"Question: Is there a difference in the incidence of Ring sign between the patients from different groups and positive AWR?"||||||0|||||||Chi-squared|||"Parameter: The difference in the incidence of Ring sign, aceto-whitening of all structures of the Inner Vulvar Ring, between the patients from different groups and positive AWR."||||0.0000
72621417|NCT02732145|144773194|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Outer versus Middle Vulvar Ring in patients with vulvar dermatosis and positive AWR?||||||0.0856|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Outer versus Middle Vulvar Ring in patients with vulvar dermatosis and positive AWR.||||0.0856
72621418|NCT02732145|144773194|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Outer versus Inner Vulvar Ring in patients with vulvar dermatosis and positive AWR?||||||0.429|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Outer versus Inner Vulvar Ring in patients with vulvar dermatosis and positive AWR.||||0.4290
72621419|NCT02732145|144773194|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Middle versus Inner Vulvar Ring in patients with vulvar dermatosis and positive AWR?||||||0.0124|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Middle versus Inner Vulvar Ring in patients with vulvar dermatosis and positive AWR.||||0.0124
72621420|NCT02732145|144773194|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Outer versus Middle Vulvar Ring in patients with vulvodynia and positive AWR?||||||0|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Outer versus Middle Vulvar Ring in patients with vulvodynia and positive AWR.||||0.0000
72621421|NCT02732145|144773194|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Outer versus Inner Vulvar Ring in patients with vulvodynia and positive AWR?||||||0|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Outer versus Inner Vulvar Ring in patients with vulvodynia and positive AWR.||||0.0000
72621422|NCT02732145|144773194|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Middle versus Inner Vulvar Ring in patients with vulvodynia and positive AWR?||||||0.1918|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Middle versus Inner Vulvar Ring in patients with vulvodynia and positive AWR.||||0.1918
72621423|NCT02732145|144773194|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Outer versus Middle Vulvar Ring in patients with impaired vulvar skin and positive AWR?||||||0|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Outer versus Middle Vulvar Ring in patients with impaired vulvar skin and positive AWR.||||0.0000
72621424|NCT02732145|144773194|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Outer versus Inner Vulvar Ring in patients with impaired vulvar skin and positive AWR?||||||0|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Outer versus Inner Vulvar Ring in patients with impaired vulvar skin and positive AWR.||||0.0000
72621425|NCT02732145|144773194|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Middle versus Inner Vulvar Ring in patients with impaired vulvar skin and positive AWR?||||||0.5822|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Middle versus Inner Vulvar Ring in patients with impaired vulvar skin and positive AWR.||||0.5822
72621426|NCT02732145|144773194|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Outer versus Middle Vulvar Ring in patients with normal vulva and positive AWR?||||||0|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Outer versus Middle Vulvar Ring in patients with normal vulva and positive AWR.||||0.0000
72621427|NCT02732145|144773194|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Outer versus Inner Vulvar Ring in patients with normal vulva and positive AWR?||||||0|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Outer versus Inner Vulvar Ring in patients with normal vulva and positive AWR.||||0.0000
72621428|NCT02732145|144773194|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Middle versus Inner Vulvar Ring in patients with normal vulva and positive AWR?||||||0.4975|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Middle versus Inner Vulvar Ring in patients with normal vulva and positive AWR.||||0.4975
72621429|NCT02732145|144773195|EQUIVALENCE|Question: Is there a difference in the velocity of the aceto-whitening occurrence among patients from different groups, in which the AWR was positive?||||||0.0003|||||||ANOVA|||Parameter: The difference in the velocity of the aceto-whitening occurrence (positive AWR) among patients from different groups, in which the AWR was positive.||||0.0003
72621430|NCT02732145|144773196|EQUIVALENCE|Question: Is there a difference in the velocity of the aceto-whitening occurrence among patients with positive AWR from different groups?||||||0.0004|||||||Kruskal-Wallis|||Parameter: The difference in the velocity of the aceto-whitening occurrence among patients with positive AWR from different groups.||||0.0004
72621431|NCT02732145|144773196|SUPERIORITY|Question: Is there a difference in the velocity of the aceto-whitening occurrence between patients with vulvar dermatosis and vulvodynia, with positive AWR?||||||0.0231|||||||Wilcoxon (Mann-Whitney)|||Parameter: The difference in the velocity of the aceto-whitening occurrence between patients with vulvar dermatosis and vulvodynia, with positive AWR.||||0.0231
72621432|NCT02732145|144773196|SUPERIORITY|Question: Is there a difference in the velocity of the aceto-whitening occurrence between the patients with normal vulva and impaired vulvar skin, with positive AWR?||||||0.0006|||||||Wilcoxon (Mann-Whitney)|||Parameter: The difference in the velocity of the aceto-whitening occurrence between the patients with normal vulva and impaired vulvar skin, with positive AWR.||||0.0006
72621433|NCT02732145|144773196|SUPERIORITY|Question: Is there a difference in the velocity of the aceto-whitening occurrence between patients with normal vulva and vulvodynia, with positive AWR?||||||0|||||||Wilcoxon (Mann-Whitney)|||Parameter: The difference in the velocity of the aceto-whitening occurrence between patients with normal vulva and vulvodynia, with positive AWR.||||0.0000
72621434|NCT02732145|144773197|EQUIVALENCE|Question: Is there a difference in the incidence of aceto-whitening of Mons Pubis among patients from different groups, with positive AWR?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of aceto-whitening of Mons Pubis among patients from different groups, with positive AWR.||||0.0000
72394313|NCT04786990|144295558|OTHER||||||<|0.0001||||||The p-value generated from the statistical test for this efficacy measure is considered nominal. An adjustment for multiplicity was not performed, and as a result, there is no control of Type 1 error in the statistical analysis of these data.|t-test, 2 sided|||Week 8||||<0.0001
72394314|NCT04786990|144295559|OTHER||||||<|0.0001||||||The p-value generated from the statistical test for this efficacy measure is considered nominal. An adjustment for multiplicity was not performed, and as a result, there is no control of Type 1 error in the statistical analysis of these data.|t-test, 2 sided|||Week 4||||<0.0001
72394315|NCT04786990|144295559|OTHER||||||<|0.0001||||||The p-value generated from the statistical test for this efficacy measure is considered nominal. An adjustment for multiplicity was not performed, and as a result, there is no control of Type 1 error in the statistical analysis of these data.|t-test, 2 sided|||Week 8||||<0.0001
72394316|NCT04786990|144295561|OTHER||||||<|0.0001||||||The p-value generated from the statistical test for this efficacy measure is considered nominal. An adjustment for multiplicity was not performed, and as a result, there is no control of Type 1 error in the statistical analysis of these data.|t-test, 2 sided|||Week 4||||<0.0001
72394317|NCT04786990|144295561|OTHER|||||||0.0002||||||The p-value generated from the statistical test for this efficacy measure is considered nominal. An adjustment for multiplicity was not performed, and as a result, there is no control of Type 1 error in the statistical analysis of these data.|t-test, 2 sided|||Week 8||||0.0002
72394318|NCT04786990|144295562|OTHER||||||<|0.0001||||||The p-value generated from the statistical test for this efficacy measure is considered nominal. An adjustment for multiplicity was not performed, and as a result, there is no control of Type 1 error in the statistical analysis of these data.|t-test, 2 sided|||Week 4||||<0.0001
72394319|NCT04786990|144295562|OTHER||||||<|0.0001||||||The p-value generated for the comparison between time points for this efficacy measure is considered nominal. An adjustment for multiplicity was not performed. There is no control of Type 1 error in the statistical analysis of these data.|t-test, 2 sided|||Week 8||||<0.0001
72394320|NCT04786990|144295563|OTHER|||||||0.0685||||||The p-value generated from the statistical test for this efficacy measure is considered nominal. An adjustment for multiplicity was not performed, and as a result, there is no control of Type 1 error in the statistical analysis of these data.|t-test, 2 sided|||Week 4||||0.0685
72502932|NCT01982630|144536193|OTHER||Difference of Least Squares Means|9.61|||||TWO_SIDED|90.0|4.42|14.81|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline TWA0-24hr of heart rate as a covariate||||14.81|4.42|
72502933|NCT01982630|144536193|OTHER||Difference of Least Squares Means|7.15|||||TWO_SIDED|90.0|1.7|12.6|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline TWA0-24hr of heart rate as a covariate||||12.60|1.70|
72564323|NCT00483548|144660354|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|0.01|STANDARD_ERROR_OF_MEAN|0.03||0.7455||95.0|-0.05|0.06|||ANCOVA|||Global severity score: Week 6; Observed cases; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.||0.06|-0.05|0.7455
72394321|NCT04786990|144295563|OTHER|||||||0.2575||||||The p-value generated from the statistical test for this efficacy measure is considered nominal. An adjustment for multiplicity was not performed, and as a result, there is no control of Type 1 error in the statistical analysis of these data|t-test, 2 sided|||Week 8||||0.2575
72394322|NCT04786990|144295564|OTHER|||||||0.0832||||||The p-value generated from the statistical test for this efficacy measure is considered nominal. An adjustment for multiplicity was not performed, and as a result, there is no control of Type 1 error in the statistical analysis of these data.|t-test, 2 sided|||Week 4||||0.0832
72394323|NCT04786990|144295564|OTHER|||||||0.3715||||||The p-value generated from the statistical test for this efficacy measure is considered nominal. An adjustment for multiplicity was not performed, and as a result, there is no control of Type 1 error in the statistical analysis of these data.|t-test, 2 sided|||Week 8||||0.3715
72394324|NCT04786990|144295565|OTHER|||||||0.0042||||||The p-value generated from the statistical test for this efficacy measure is considered nominal. An adjustment for multiplicity was not performed, and as a result, there is no control of Type 1 error in the statistical analysis of these data|t-test, 2 sided|||Week 4||||0.0042
72394325|NCT04786990|144295565|OTHER|||||||0.0019||||||The p-value generated from the statistical test for this efficacy measure is considered nominal. An adjustment for multiplicity was not performed, and as a result, there is no control of Type 1 error in the statistical analysis of these data.|t-test, 2 sided|||Week 8||||0.0019
72502934|NCT01982630|144536194|OTHER||Difference of Least Squares Means|-3.97|||||TWO_SIDED|90.0|-6.8|-1.14|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline peak heart rate as a covariate||||-1.14|-6.80|
72564324|NCT00483548|144660354|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|0.02|STANDARD_ERROR_OF_MEAN|0.02||0.3278||95.0|-0.02|0.05|||ANCOVA|||Incapacitation score: Week 2; Observed cases; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.||0.05|-0.02|0.3278
72621435|NCT02732145|144773197|EQUIVALENCE|Question: Is there a difference in the incidence of aceto-whitening of Labia Majora among patients from different groups, with positive AWR?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of aceto-whitening of Labia Majora among patients from different groups, with positive AWR.||||0.0000
72394326|NCT04786990|144295566|OTHER||||||<|0.0001||||||The p-value generated from the statistical test for this efficacy measure is considered nominal. An adjustment for multiplicity was not performed, and as a result, there is no control of Type 1 error in the statistical analysis of these data|t-test, 2 sided|||Week 4||||<0.0001
72394327|NCT04786990|144295566|OTHER|||||||0.0025||||||The p-value generated from the statistical test for this efficacy measure is considered nominal. An adjustment for multiplicity was not performed, and as a result, there is no control of Type 1 error in the statistical analysis of these data|t-test, 2 sided|||Week 8||||0.0025
72621436|NCT02732145|144773197|EQUIVALENCE|Question: Is there a difference in the incidence of aceto-whitening of the Perineum among patients from different groups, with positive AWR?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of aceto-whitening of the Perineum among patients from different groups, with positive AWR.||||0.0000
72465786|NCT00863798|144454576|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.53||||0.027|TWO_SIDED|95.0|0.06|1.0|||ANCOVA|||"Analysis was conducted using ANCOVA on the change from baseline with treatment as a factor and corresponding baseline value as a covariate for work/studies component score."||1.00|0.06|0.027
72465787|NCT00863798|144454576|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.5||||0.045|TWO_SIDED|95.0|0.01|0.98|||ANCOVA|||"Analysis was conducted using ANCOVA on the change from baseline with treatment as a factor and corresponding baseline value as a covariate for social life and leisure activities component score."||0.98|0.01|0.045
72465788|NCT00863798|144454576|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.27||||0.277|TWO_SIDED|95.0|-0.22|0.76|||ANCOVA|||"Analysis was conducted using ANCOVA on the change from baseline with treatment as a factor and corresponding baseline value as a covariate for social life and leisure activities component score."||0.76|-0.22|0.277
72502935|NCT01982630|144536194|OTHER||Difference of Least Squares Means|-0.7|||||TWO_SIDED|90.0|-4.33|2.93|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline peak heart rate as a covariate||||2.93|-4.33|
72502936|NCT01982630|144536194|OTHER||Difference of Least Squares Means|3.26|||||TWO_SIDED|90.0|-0.54|7.06|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline peak heart rate as a covariate||||7.06|-0.54|
72502937|NCT01982630|144536195|OTHER||Difference of Least Squares Means|-1.58|||||TWO_SIDED|90.0|-5.31|2.15|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline peak heart rate as a covariate||||2.15|-5.31|
72502938|NCT01982630|144536195|OTHER||Difference of Least Squares Means|2.52|||||TWO_SIDED|90.0|-2.32|7.35|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline peak heart rate as a covariate||||7.35|-2.32|
72502939|NCT01982630|144536195|OTHER||Difference of Least Squares Means|4.1|||||TWO_SIDED|90.0|-0.96|9.16|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline peak heart rate as a covariate||||9.16|-0.96|
72502940|NCT01982630|144536196|OTHER||Difference of Least Squares Means|-3.48|||||TWO_SIDED|90.0|-7.31|0.34|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline peak heart rate as a covariate||||0.34|-7.31|
72502941|NCT01982630|144536196|OTHER||Difference of Least Squares Means|3.96|||||TWO_SIDED|90.0|-1.11|9.03|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline peak heart rate as a covariate||||9.03|-1.11|
72502942|NCT01982630|144536196|OTHER||Difference of Least Squares Means|7.44|||||TWO_SIDED|90.0|2.16|12.73|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline peak heart rate as a covariate||||12.73|2.16|
72502943|NCT01982630|144536197|OTHER||Difference of Least Squares Means|0.03|||||TWO_SIDED|90.0|-4.51|4.57|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline peak heart rate as a covariate||||4.57|-4.51|
72502944|NCT01982630|144536197|OTHER||Difference of Least Squares Means|4.7|||||TWO_SIDED|90.0|-1.33|10.73|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline peak heart rate as a covariate||||10.73|-1.33|
72502945|NCT01982630|144536197|OTHER||Difference of Least Squares Means|4.66|||||TWO_SIDED|90.0|-1.67|11.0|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline peak heart rate as a covariate||||11.00|-1.67|
72465789|NCT00863798|144454576|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.45||||0.056|TWO_SIDED|95.0|-0.01|0.91|||ANCOVA|||"Analysis was conducted using ANCOVA on the change from baseline with treatment as a factor and corresponding baseline value as a covariate for family life/home responsibilities component score."||0.91|-0.01|0.056
72502946|NCT01982630|144536198|OTHER||Difference of Least Squares Means|3.34|||||TWO_SIDED|90.0|-0.7|7.39|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline peak heart rate as a covariate||||7.39|-0.70|
72502947|NCT01982630|144536198|OTHER||Difference of Least Squares Means|8.88|||||TWO_SIDED|90.0|3.53|14.23|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline peak heart rate as a covariate||||14.23|3.53|
72502948|NCT01982630|144536198|OTHER||Difference of Least Squares Means|5.54|||||TWO_SIDED|90.0|-0.08|11.15|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline peak heart rate as a covariate||||11.15|-0.08|
72502949|NCT01982630|144536199|OTHER||Difference of Least Squares Means|-3.55|||||TWO_SIDED|90.0|-6.98|-0.12|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline RMHR as a covariate||||-0.12|-6.98|
72502950|NCT01982630|144536199|OTHER||Difference of Least Squares Means|1.05|||||TWO_SIDED|90.0|-3.38|5.49|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline RMHR as a covariate||||5.49|-3.38|
72502951|NCT01982630|144536199|OTHER||Difference of Least Squares Means|4.61|||||TWO_SIDED|90.0|-0.02|9.23|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline RMHR as a covariate||||9.23|-0.02|
72465790|NCT00863798|144454576|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.22||||0.355|TWO_SIDED|95.0|-0.24|0.68|||ANCOVA|||"Analysis was conducted using ANCOVA on the change from baseline with treatment as a factor and corresponding baseline value as a covariate for family life/home responsibilities component score."||0.68|-0.24|0.355
72465791|NCT00863798|144454577|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.54||||0.002|TWO_SIDED|95.0|-2.53|-0.56|||ANCOVA|||Analysis was conducted using ANCOVA on the change from baseline with treatment as a factor and corresponding baseline value as a covariate.||-0.56|-2.53|0.002
72465792|NCT00863798|144454577|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.77||||0.129|TWO_SIDED|95.0|-1.75|0.22|||ANCOVA|||Analysis was conducted using ANCOVA on the change from baseline with treatment as a factor and corresponding baseline value as a covariate.||0.22|-1.75|0.129
72465793|NCT00863798|144454578|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.8||||0.3097|TWO_SIDED|95.0|0.52|1.23|||Regression, Linear|||Analysis was conducted using a logistic regression model with treatment and gender as factors and baseline sexual dysfunction status as a covariate.||1.23|0.52|0.3097
72465794|NCT00863798|144454578|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.272||||0.2794|TWO_SIDED|95.0|0.82|1.97|||Regression, Logistic|||Analysis was conducted using a logistic regression model with treatment and gender as factors and baseline sexual dysfunction status as a covariate.||1.97|0.82|0.2794
72465795|NCT00863798|144454580|SUPERIORITY_OR_OTHER|||||||0.805|TWO_SIDED||||||t-test, 2 sided|||To address the multiplicity effect inherent in these comparisons, adjusted p-values based on the false discovery rate was used at Week 8.||||0.805
72465796|NCT00863798|144454580|SUPERIORITY_OR_OTHER|||||||0.805|TWO_SIDED||||||t-test, 2 sided|||To address the multiplicity effect inherent in these comparisons, adjusted p-values based on the false discovery rate was used at Week 9.||||0.805
72465797|NCT00863798|144454580|SUPERIORITY_OR_OTHER|||||||0.978|TWO_SIDED||||||t-test, 2 sided|||To address the multiplicity effect inherent in these comparisons, adjusted p-values based on the false discovery rate was used at Week 10.||||0.978
72465798|NCT00863798|144454580|SUPERIORITY_OR_OTHER|||||||0.805|TWO_SIDED||||||Regression, Logistic|||To address the multiplicity effect inherent in these comparisons, adjusted p-values based on the false discovery rate was used at Week 8.||||0.805
72465799|NCT00863798|144454580|SUPERIORITY_OR_OTHER|||||||0.154|TWO_SIDED||||||t-test, 2 sided|||To address the multiplicity effect inherent in these comparisons, adjusted p-values based on the false discovery rate was used at Week 9.||||0.154
72465800|NCT00863798|144454580|SUPERIORITY_OR_OTHER|||||||0.805|TWO_SIDED||||||t-test, 2 sided|||To address the multiplicity effect inherent in these comparisons, adjusted p-values based on the false discovery rate was used at Week 10.||||0.805
72465801|NCT01917006|144454627|SUPERIORITY||Least square mean difference|0.11||||0.393||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from analysis of covariance (ANCOVA) Model with treatment as fixed effect and baseline geometric mean IELT as covariate.|ANCOVA|||||||0.393
72465802|NCT01917006|144454627|SUPERIORITY||Least Square Mean Difference|0.25||||0.263||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.|ANCOVA|||||||0.263
72465803|NCT01917006|144454627|SUPERIORITY||Least square mean difference|-0.39||||0.861||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.|ANCOVA|||||||0.861
72465804|NCT01917006|144454627|SUPERIORITY||Least square mean difference|-0.14||||0.647||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.|ANCOVA|||||||0.647
72621437|NCT02732145|144773197|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Mons Pubis versus Labia Majora in patients with vulvar dermatosis and positive AWR?||||||0.0128|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Mons Pubis versus Labia Majora in patients with vulvar dermatosis and positive AWR.||||0.0128
72465805|NCT01917006|144454627|SUPERIORITY||Least square mean difference|-0.13||||0.645||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.|ANCOVA|||||||0.645
72465806|NCT01917006|144454627|SUPERIORITY||Least square mean difference|0.15||||0.343||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.|ANCOVA|||||||0.343
72465807|NCT01917006|144454628|SUPERIORITY||Least square mean difference|55.33||||0.184||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 1 versus (vs) Placebo at Week 2||||0.184
72465808|NCT01917006|144454628|SUPERIORITY||Least square mean difference|170.21||||0.002||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 2 vs Placebo at Week 2||||0.002
72370668|NCT00488683|144251641|SUPERIORITY_OR_OTHER||R-square|0.0009||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration at day 1 in the serum of mother for the serogroup Y||||
72465809|NCT01917006|144454628|SUPERIORITY||Least square mean difference|12.73||||0.404||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 3 vs Placebo at Week 2||||0.404
72465810|NCT01917006|144454628|SUPERIORITY||Least square mean difference|24.23||||0.328||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 4 vs Placebo at Week 2||||0.328
72465811|NCT01917006|144454628|SUPERIORITY||Least square mean difference|18.48||||0.362||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 5 vs Placebo at Week 2||||0.362
72502952|NCT01982630|144536200|OTHER||Difference of Least Squares Means|-1.16|||||TWO_SIDED|90.0|-4.59|2.28|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline RMHR as a covariate||||2.28|-4.59|
72621438|NCT02732145|144773197|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Mons Pubis versus Perineum in patients with vulvar dermatosis and positive AWR?||||||0|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Mons Pubis versus Perineum in patients with vulvar dermatosis and positive AWR.||||0.0000
72465812|NCT01917006|144454628|SUPERIORITY||Least square mean difference|45.42||||0.203||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 6 vs Placebo at Week 2||||0.203
72465813|NCT01917006|144454628|SUPERIORITY||Least square mean difference|33.05||||0.322||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 1 vs Placebo at Week 4||||0.322
72465814|NCT01917006|144454628|SUPERIORITY||Least square mean difference|148.86||||0.015||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 2 vs Placebo at Week 4||||0.015
72465815|NCT01917006|144454628|SUPERIORITY||Least square mean difference|-6.2||||0.541||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 3 vs Placebo at Week 4||||0.541
72465816|NCT01917006|144454628|SUPERIORITY||Least square mean difference|6.47||||0.459||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 4 vs Placebo at Week 4||||0.459
72465817|NCT01917006|144454628|SUPERIORITY||Least square mean difference|1.32||||0.491||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 5 vs Placebo at Week 4||||0.491
72465818|NCT01917006|144454628|SUPERIORITY||Least square mean difference|36.8||||0.281||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 6 vs Placebo at Week 4||||0.281
72465819|NCT01917006|144454628|SUPERIORITY||Least square mean difference|14.12||||0.424||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 1 vs Placebo at Week 6||||0.424
72465820|NCT01917006|144454628|SUPERIORITY||Least square mean difference|136.96||||0.026||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 2 vs Placebo at Week 6||||0.026
72465821|NCT01917006|144454628|SUPERIORITY||Least square mean difference|-27.62||||0.67||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 3 vs Placebo at Week 6||||0.670
72465822|NCT01917006|144454628|SUPERIORITY||Least square mean difference|-10.06||||0.561||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 4 vs Placebo at Week 6||||0.561
72465823|NCT01917006|144454628|SUPERIORITY||Least square mean difference|-16.58||||0.604||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 5 vs Placebo at Week 6||||0.604
72465824|NCT01917006|144454628|SUPERIORITY||Least square mean difference|17.76||||0.394||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 6 vs Placebo at Week 6||||0.394
72465825|NCT01917006|144454628|SUPERIORITY||Least square mean difference|-5.94||||0.532||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 1 vs Placebo at Week 8||||0.532
72465826|NCT01917006|144454628|SUPERIORITY||Least square mean difference|111.27||||0.058||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 2 vs Placebo at Week 8||||0.058
72465827|NCT01917006|144454628|SUPERIORITY||Least square mean difference|-48.65||||0.778||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 3 vs Placebo at Week 8||||0.778
72502953|NCT01982630|144536200|OTHER||Difference of Least Squares Means|8.65|||||TWO_SIDED|90.0|3.99|13.31|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline RMHR as a covariate||||13.31|3.99|
72465828|NCT01917006|144454628|SUPERIORITY||Least square mean difference|-27.74||||0.662||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 4 vs Placebo at Week 8||||0.662
72465829|NCT01917006|144454628|SUPERIORITY||Least square mean difference|-35.72||||0.712||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 5 vs Placebo at Week 8||||0.712
72465830|NCT01917006|144454628|SUPERIORITY||Least square mean difference|-0.18||||0.501||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 6 vs Placebo at Week 8||||0.501
72394328|NCT04786990|144295567|OTHER|||||||0.0161||||||The p-value generated from the statistical test for this efficacy measure is considered nominal. An adjustment for multiplicity was not performed, and as a result, there is no control of Type 1 error in the statistical analysis of these data.|t-test, 2 sided|||Week 4||||0.0161
72394329|NCT04786990|144295567|OTHER|||||||0.0122||||||The p-value generated from the statistical test for this efficacy measure is considered nominal. An adjustment for multiplicity was not performed, and as a result, there is no control of Type 1 error in the statistical analysis of these data.|t-test, 2 sided|||Week 8||||0.0122
72394330|NCT04786990|144295568|OTHER||||||<|0.0001||||||The p-value generated from the statistical test for this efficacy measure is considered nominal. An adjustment for multiplicity was not performed, and as a result, there is no control of Type 1 error in the statistical analysis of these data.|t-test, 2 sided|||Week 4||||<0.0001
72394331|NCT04786990|144295568|OTHER||||||<|0.0001||||||The p-value generated from the statistical test for this efficacy measure is considered nominal. An adjustment for multiplicity was not performed, and as a result, there is no control of Type 1 error in the statistical analysis of these data.|t-test, 2 sided|||Week 8||||<0.0001
72394332|NCT04786990|144295569|OTHER|||||||0.0002||||||The p-value generated from the statistical test for this efficacy measure is considered nominal. An adjustment for multiplicity was not performed, and as a result, there is no control of Type 1 error in the statistical analysis of these data.|t-test, 2 sided|||Week 4||||0.0002
72394333|NCT04786990|144295569|OTHER||||||<|0.0001||||||The p-value generated from the statistical test for this efficacy measure is considered nominal. An adjustment for multiplicity was not performed, and as a result, there is no control of Type 1 error in the statistical analysis of these data.|t-test, 2 sided|||Week 8||||<0.0001
72394334|NCT04786990|144295570|OTHER||||||<|0.0001||||||The p-value generated from the statistical test for this efficacy measure is considered nominal. An adjustment for multiplicity was not performed, and as a result, there is no control of Type 1 error in the statistical analysis of these data.|t-test, 2 sided|||Week 4||||<0.0001
72394335|NCT04786990|144295570|OTHER||||||<|0.0001||||||The p-value generated from the statistical test for this efficacy measure is considered nominal. An adjustment for multiplicity was not performed, and as a result, there is no control of Type 1 error in the statistical analysis of these data.|t-test, 2 sided|||Week 8||||<0.0001
72465831|NCT01917006|144454628|SUPERIORITY||Least square mean difference|-12.14||||0.565||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 1 vs Placebo at Week 10||||0.565
72465832|NCT01917006|144454628|SUPERIORITY||Least square mean difference|102.44||||0.071||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 2 vs Placebo at Week 10||||0.071
72502954|NCT01982630|144536200|OTHER||Difference of Least Squares Means|9.8|||||TWO_SIDED|90.0|4.96|14.65|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline RMHR as a covariate||||14.65|4.96|
72502955|NCT01982630|144536201|OTHER||Difference of Least Squares Means|-4.04|||||TWO_SIDED|90.0|-7.52|-0.56|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline RMHR as a covariate||||-0.56|-7.52|
72394336|NCT04786990|144295571|OTHER|||||||0.0005||||||The p-value generated from the statistical test for this efficacy measure is considered nominal. An adjustment for multiplicity was not performed, and as a result, there is no control of Type 1 error in the statistical analysis of these data.|t-test, 2 sided|||Week 4 versus Week 8||||0.0005
72394337|NCT04786990|144295572|OTHER|||||||0.0005||||||The p-value generated from the statistical test for this efficacy measure is considered nominal. An adjustment for multiplicity was not performed, and as a result, there is no control of Type 1 error in the statistical analysis of these data.|t-test, 2 sided|||Week 4 versus Week 8||||0.0005
72394338|NCT04786990|144295573|OTHER|||||||0.0016||||||The p-value generated from the statistical test for this efficacy measure is considered nominal. An adjustment for multiplicity was not performed, and as a result, there is no control of Type 1 error in the statistical analysis of these data.|t-test, 2 sided|||Week 4 versus Week 8||||0.0016
72465833|NCT01917006|144454628|SUPERIORITY||Least square mean difference|-52.81||||0.799||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 3 vs Placebo at Week 10||||0.799
72502956|NCT01982630|144536201|OTHER||Difference of Least Squares Means|10.23|||||TWO_SIDED|90.0|5.57|14.89|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline RMHR as a covariate||||14.89|5.57|
72394339|NCT04786990|144295574|OTHER|||||||0.89||||||The p-value generated from the statistical test for this efficacy measure is considered nominal. An adjustment for multiplicity was not performed, and as a result, there is no control of Type 1 error in the statistical analysis of these data.|t-test, 2 sided|||Week 4 versus Week 8||||0.8900
72394340|NCT04786990|144295575|OTHER|||||||0.3269||||||The p-value generated from the statistical test for this efficacy measure is considered nominal. An adjustment for multiplicity was not performed, and as a result, there is no control of Type 1 error in the statistical analysis of these data.|t-test, 2 sided|||Week 4 versus Week 8||||0.3269
72394341|NCT04786990|144295576|OTHER|||||||0.5085||||||The p-value generated from the statistical test for this efficacy measure is considered nominal. An adjustment for multiplicity was not performed, and as a result, there is no control of Type 1 error in the statistical analysis of these data.|t-test, 2 sided|||Week 4 versus Week 8||||0.5085
72394342|NCT04786990|144295577|OTHER|||||||0.3484||||||The p-value generated from the statistical test for this efficacy measure is considered nominal. An adjustment for multiplicity was not performed, and as a result, there is no control of Type 1 error in the statistical analysis of these data.|t-test, 2 sided|||Week 4 versus Week 8||||0.3484
72502957|NCT01982630|144536201|OTHER||Difference of Least Squares Means|14.27|||||TWO_SIDED|90.0|9.38|19.15|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline RMHR as a covariate||||19.15|9.38|
72465834|NCT01917006|144454628|SUPERIORITY||Least square mean difference|-30.81||||0.681||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 4 vs Placebo at Week 10||||0.681
72465835|NCT01917006|144454628|SUPERIORITY||Least square mean difference|-40.68||||0.741||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 5 vs Placebo at Week 10||||0.741
72465836|NCT01917006|144454628|SUPERIORITY||Least square mean difference|-4.33||||0.526||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 6 vs Placebo at Week 10||||0.526
72502958|NCT01982630|144536202|OTHER||Difference of Least Squares Means|-2.12|||||TWO_SIDED|90.0|-5.7|1.47|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline RMHR as a covariate||||1.47|-5.70|
72465837|NCT01917006|144454628|SUPERIORITY||Least square mean difference|-14.76||||0.584||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 1 vs Placebo at Week 12||||0.584
72502959|NCT01982630|144536202|OTHER||Difference of Least Squares Means|13.34|||||TWO_SIDED|90.0|8.64|18.03|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline RMHR as a covariate||||18.03|8.64|
72502960|NCT01982630|144536202|OTHER||Difference of Least Squares Means|15.45|||||TWO_SIDED|90.0|10.53|20.38|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline RMHR as a covariate||||20.38|10.53|
72502961|NCT01982630|144536203|OTHER||Difference of Least Squares Means|2.11|||||TWO_SIDED|90.0|-1.47|5.7|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline RMHR as a covariate||||5.70|-1.47|
72465838|NCT01917006|144454628|SUPERIORITY||Least square mean difference|84.09||||0.101||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 2 vs Placebo at Week 12||||0.101
72502962|NCT01982630|144536203|OTHER||Difference of Least Squares Means|10.43|||||TWO_SIDED|90.0|5.73|15.13|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline RMHR as a covariate||||15.13|5.73|
72502963|NCT01982630|144536203|OTHER||Difference of Least Squares Means|8.32|||||TWO_SIDED|90.0|3.4|13.24|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline RMHR as a covariate||||13.24|3.40|
72394343|NCT04786990|144295578|OTHER|||||||0.4385||||||The p-value generated from the statistical test for this efficacy measure is considered nominal. An adjustment for multiplicity was not performed, and as a result, there is no control of Type 1 error in the statistical analysis of these data.|t-test, 2 sided|||Week 4 versus Week 8||||0.4385
72465839|NCT01917006|144454628|SUPERIORITY||Least square mean difference|-55.14||||0.823||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 3 vs Placebo at Week 12||||0.823
72621439|NCT02732145|144773197|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Labia Majora versus Perineum in patients with vulvar dermatosis and positive AWR?||||||0.0635|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Labia Majora versus Perineum in patients with vulvar dermatosis and positive AWR.||||0.0635
72394344|NCT04786990|144295579|OTHER|||||||0.5073||||||The p-value generated from the statistical test for this efficacy measure is considered nominal. An adjustment for multiplicity was not performed, and as a result, there is no control of Type 1 error in the statistical analysis of these data.|t-test, 2 sided|||Week 4 versus Week 8||||0.5073
72465840|NCT01917006|144454628|SUPERIORITY||Least square mean difference|-40.18||||0.741||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 4 vs Placebo at Week 12||||0.741
72621440|NCT02732145|144773197|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Mons Pubis versus Labia Majora in patients with vulvodynia and positive AWR?||||||0.0429|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Mons Pubis versus Labia Majora in patients with vulvodynia and positive AWR.||||0.0429
72621441|NCT02732145|144773197|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Mons Pubis versus Perineum in patients with vulvodynia and positive AWR?||||||0.0011|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Mons Pubis versus Perineum in patients with vulvodynia and positive AWR.||||0.0011
72621442|NCT02732145|144773197|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Labia Majora versus Perineum in patients with vulvodynia and positive AWR?||||||0.0936|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Labia Majora versus Perineum in patients with vulvodynia and positive AWR.||||0.0936
72621443|NCT02732145|144773197|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Mons Pubis versus Labia Majora in patients with impaired vulvar skin and positive AWR?||||||1|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Mons Pubis versus Labia Majora in patients with impaired vulvar skin and positive AWR.||||1.0000
72621444|NCT02732145|144773197|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Mons Pubis versus Perineum in patients with impaired vulvar skin and positive AWR?||||||0.0429|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Mons Pubis versus Perineum in patients with impaired vulvar skin and positive AWR.||||0.0429
72621445|NCT02732145|144773197|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Labia Majora versus Perineum in patients with impaired vulvar skin and positive AWR?||||||0.0429|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Labia Majora versus Perineum in patients with impaired vulvar skin and positive AWR.||||0.0429
72621446|NCT02732145|144773198|EQUIVALENCE|Question: Is there a difference in the incidence of aceto-whitening of the Anterior Commissure among patients from different groups, with positive AWR?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of aceto-whitening of the Anterior Commissure among patients from different groups, with positive AWR.||||0.0000
72621447|NCT02732145|144773198|EQUIVALENCE|Question: Is there a difference in the incidence of aceto-whitening of the Interlabial Sulci among patients from different groups, with positive AWR?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of aceto-whitening of the Interlabial Sulci among patients from different groups, with positive AWR.||||0.0000
72621448|NCT02732145|144773198|EQUIVALENCE|Question: Is there a difference in the incidence of aceto-whitening of the Labia Minora among patients from different groups, with positive AWR?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of aceto-whitening of the Labia Minora among patients from different groups, with positive AWR.||||0.0000
72621449|NCT02732145|144773198|EQUIVALENCE|Question: Is there a difference in the incidence of aceto-whitening of the Posterior Commissure among patients from different groups, with positive AWR?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of aceto-whitening of the Posterior Commissure among patients from different groups, with positive AWR.||||0.0000
72621450|NCT02732145|144773198|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of the Anterior Commissure versus Interlabial Sulci in patients with vulvar dermatosis and positive AWR?||||||0.0318|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Anterior Commissure versus Interlabial Sulci in patients with vulvar dermatosis and positive AWR.||||0.0318
72621451|NCT02732145|144773198|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of the Anterior Commissure versus Labia Minora in patients with vulvar dermatosis and positive AWR?||||||0.0318|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Anterior Commissure versus Labia Minora in patients with vulvar dermatosis and positive AWR.||||0.0318
72621452|NCT02732145|144773198|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of the Anterior Commissure versus Posterior Commissure in patients with vulvar dermatosis and positive AWR?||||||0|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Anterior Commissure versus Posterior Commissure in patients with vulvar dermatosis and positive AWR.||||0.0000
72621453|NCT02732145|144773198|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of the Interlabial Sulci versus Labia Minora in patients with vulvar dermatosis and positive AWR?||||||1|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Interlabial Sulci versus Labia Minora in patients with vulvar dermatosis and positive AWR.||||1.0000
72621454|NCT02732145|144773198|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of the Interlabial Sulci versus Posterior Commissure in patients with vulvar dermatosis and positive AWR?||||||0.0389|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Interlabial Sulci versus Posterior Commissure in patients with vulvar dermatosis and positive AWR.||||0.0389
72465841|NCT01917006|144454628|SUPERIORITY||Least square mean difference|-41.31||||0.756||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 5 vs Placebo at Week 12||||0.756
72465842|NCT01917006|144454628|SUPERIORITY||Least square mean difference|-2.57||||0.517||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 6 vs Placebo at Week 12||||0.517
72465843|NCT01917006|144454629|SUPERIORITY||Least square mean difference|0.59||||0.079||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 1 vs Placebo at Week 2||||0.079
72502964|NCT01982630|144536219|OTHER||Difference of Least Squares Means|29.56|||||TWO_SIDED|90.0|4.34|54.77|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline 24-hour WMG as a covariate||||54.77|4.34|
72502965|NCT01982630|144536219|OTHER||Difference of Least Squares Means|26.1|||||TWO_SIDED|90.0|2.02|50.19|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline 24-hour WMG as a covariate||||50.19|2.02|
72502966|NCT01982630|144536219|OTHER||Difference of Least Squares Means|3.45|||||TWO_SIDED|90.0|-20.23|27.14|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline 24-hour WMG as a covariate||||27.14|-20.23|
72621455|NCT02732145|144773198|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of the Labia Minora versus Posterior Commissure in patients with vulvar dermatosis and positive AWR?||||||0.0389|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Labia Minora versus Posterior Commissure in patients with vulvar dermatosis and positive AWR.||||0.0389
72465844|NCT01917006|144454629|SUPERIORITY||Least square mean difference|0.77||||0.025||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 2 vs Placebo at Week 2||||0.025
72465845|NCT01917006|144454629|SUPERIORITY||Least square mean difference|0.07||||0.417||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 3 vs Placebo at Week 2||||0.417
72465846|NCT01917006|144454629|SUPERIORITY||Least square mean difference|0.16||||0.33||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 4 vs Placebo at Week 2||||0.330
72465847|NCT01917006|144454629|SUPERIORITY||Least square mean difference|0.3||||0.199||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 5 vs Placebo at Week 2||||0.199
72465848|NCT01917006|144454629|SUPERIORITY||Least square mean difference|0.45||||0.113||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 6 vs Placebo at Week 2||||0.113
72465849|NCT01917006|144454629|SUPERIORITY||Least square mean difference|0.5||||0.127||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 1 vs Placebo at Week 4||||0.127
72465850|NCT01917006|144454629|SUPERIORITY||Least square mean difference|0.56||||0.087||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 2 vs Placebo at Week 4||||0.087
72502967|NCT01982630|144536219|OTHER||Difference of Least Squares Means|-26.45|||||TWO_SIDED|90.0|-49.96|-2.93|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline 24-hour WMG as a covariate||||-2.93|-49.96|
72502968|NCT01982630|144536219|OTHER||Difference of Least Squares Means|-29.9|||||TWO_SIDED|90.0|-52.04|-7.77|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline 24-hour WMG as a covariate||||-7.77|-52.04|
72370669|NCT00488683|144251642|SUPERIORITY_OR_OTHER||R-square|0.34||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and hSBA titers at 12 months of age for the serogroup A||||
72370670|NCT00488683|144251642|SUPERIORITY_OR_OTHER||R-square|0.14||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between memory B cells one month after primary vaccination and hSBA titers at 12 months of age for the serogroup A||||
72370671|NCT00488683|144251642|SUPERIORITY_OR_OTHER||R-square|0.09||||||95.0|||||Regression, Linear|||Linear regression coefficient between demographic factors, memory B cells at 5 months of age and hSBA titers at 12 months of age after a 2, 4-month course of MenACWY-CRM vaccination for the serogroup C||||
72370672|NCT00488683|144251642|SUPERIORITY_OR_OTHER||R-square|0.16||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between memory B cells one month after primary vaccination and hSBA titers at 12 months of age for the serogroup C||||
72370673|NCT00488683|144251642|SUPERIORITY_OR_OTHER||R-square|0.22||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and hSBA titers at 12 months of age for the serogroup W-135||||
72370674|NCT00488683|144251642|SUPERIORITY_OR_OTHER||R-square|0.33||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between memory B cells one month after primary vaccination and hSBA titers at 12 months of age for the serogroup W-135||||
72394345|NCT04786990|144295580|OTHER|||||||0.9119||||||The p-value generated from the statistical test for this efficacy measure is considered nominal. An adjustment for multiplicity was not performed, and as a result, there is no control of Type 1 error in the statistical analysis of these data.|t-test, 2 sided|||Week 4 versus Week 8||||0.9119
72394346|NCT04786990|144295581|OTHER|||||||0.014||||||The p-value generated from the statistical test for this efficacy measure is considered nominal. An adjustment for multiplicity was not performed, and as a result, there is no control of Type 1 error in the statistical analysis of these data.|t-test, 2 sided|||Week 4 versus Week 8||||0.0140
72394347|NCT04786990|144295582|OTHER|||||||0.1542||||||The p-value generated from the statistical test for this efficacy measure is considered nominal. An adjustment for multiplicity was not performed, and as a result, there is no control of Type 1 error in the statistical analysis of these data.|t-test, 2 sided|||Week 4 versus Week 8||||0.1542
72394348|NCT04786990|144295583|OTHER|||||||0.0086||||||The p-value generated from the statistical test for this efficacy measure is considered nominal. An adjustment for multiplicity was not performed, and as a result, there is no control of Type 1 error in the statistical analysis of these data.|t-test, 2 sided|||Week 4 versus Week 8||||0.0086
72394349|NCT04786990|144295584|OTHER||||||<|0.0001||||||The p-value generated from the statistical test for this efficacy measure is considered nominal. An adjustment for multiplicity was not performed, and as a result, there is no control of Type 1 error in the statistical analysis of these data.|t-test, 2 sided|||Week 4||||<0.0001
72465851|NCT01917006|144454629|SUPERIORITY||Least square mean difference|-0.04||||0.543||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 3 vs Placebo at Week 4||||0.543
72465852|NCT01917006|144454629|SUPERIORITY||Least square mean difference|0.12||||0.377||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 4 vs Placebo at Week 4||||0.377
72465853|NCT01917006|144454629|SUPERIORITY||Least square mean difference|0.17||||0.321||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 5 vs Placebo at Week 4||||0.321
72502969|NCT01982630|144536219|OTHER||Difference of Least Squares Means|-56.0|||||TWO_SIDED|90.0|-79.53|-32.48|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline 24-hour WMG as a covariate||||-32.48|-79.53|
72465854|NCT01917006|144454629|SUPERIORITY||Least square mean difference|0.4||||0.149||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 6 vs Placebo at Week 4||||0.149
72465855|NCT01917006|144454629|SUPERIORITY||Least square mean difference|0.35||||0.215||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 1 vs Placebo at Week 6||||0.215
72394350|NCT04786990|144295584|OTHER||||||<|0.0001||||||The p-value generated from the statistical test for this efficacy measure is considered nominal. An adjustment for multiplicity was not performed, and as a result, there is no control of Type 1 error in the statistical analysis of these data.|t-test, 2 sided|||Week 8||||<0.0001
72394351|NCT04786990|144295585|OTHER||||||<|0.0001||||||The p-value generated from the statistical test for this efficacy measure is considered nominal. An adjustment for multiplicity was not performed, and as a result, there is no control of Type 1 error in the statistical analysis of these data.|t-test, 2 sided|||Week 4||||<0.0001
72394352|NCT04786990|144295585|OTHER||||||<|0.0001||||||The p-value generated from the statistical test for this efficacy measure is considered nominal. An adjustment for multiplicity was not performed, and as a result, there is no control of Type 1 error in the statistical analysis of these data.|t-test, 2 sided|||Week 8||||<0.0001
72394353|NCT04786990|144295586|OTHER|||||||0.5582||||||The p-value generated from the statistical test for this efficacy measure is considered nominal. An adjustment for multiplicity was not performed, and as a result, there is no control of Type 1 error in the statistical analysis of these data.|t-test, 2 sided|||"Week 4; Morning PR-ADHD-RS-5 Total score versus Evening PR-ADHD-RS-5 Total score"||||0.5582
72394354|NCT04786990|144295587|OTHER|||||||0.5061||||||The p-value generated from the statistical test for this efficacy measure is considered nominal. An adjustment for multiplicity was not performed, and as a result, there is no control of Type 1 error in the statistical analysis of these data.|t-test, 2 sided|||"Week 8; Morning PR-ADHD-RS-5 Total score versus Evening PR-ADHD-RS-5 Total score"||||0.5061
72394355|NCT01782222|144295588|SUPERIORITY_OR_OTHER||Least Square Mean|0.04|STANDARD_ERROR_OF_MEAN|1.24||0.977|TWO_SIDED|95.0|-2.42|2.5|||ANCOVA|ANCOVA model for the change from Baseline to End of Maintenance containing treatment and disease stage as factors, and Baseline value as covariate.||||2.50|-2.42|0.977
72502970|NCT01982630|144536220|OTHER||Difference of Least Squares Means|14.96|||||TWO_SIDED|90.0|-10.25|40.18|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline 24-hour WMG as a covariate||||40.18|-10.25|
72502971|NCT01982630|144536220|OTHER||Difference of Least Squares Means|6.57|||||TWO_SIDED|90.0|-17.52|30.65|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline 24-hour WMG as a covariate||||30.65|-17.52|
72502972|NCT01982630|144536220|OTHER||Difference of Least Squares Means|8.4|||||TWO_SIDED|90.0|-15.29|32.08|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline 24-hour WMG as a covariate||||32.08|-15.29|
72502973|NCT01982630|144536220|OTHER||Difference of Least Squares Means|-35.23|||||TWO_SIDED|90.0|-58.75|-11.72|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline 24-hour WMG as a covariate||||-11.72|-58.75|
72502974|NCT01982630|144536220|OTHER||Difference of Least Squares Means|-43.63|||||TWO_SIDED|90.0|-65.77|-21.5|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline 24-hour WMG as a covariate||||-21.50|-65.77|
72465856|NCT01917006|144454629|SUPERIORITY||Least square mean difference|0.47||||0.126||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 2 vs Placebo at Week 6||||0.126
72465857|NCT01917006|144454629|SUPERIORITY||Least square mean difference|-0.28||||0.774||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 3 vs Placebo at Week 6||||0.774
72502975|NCT01982630|144536220|OTHER||Difference of Least Squares Means|-50.2|||||TWO_SIDED|90.0|-73.72|-26.68|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline 24-hour WMG as a covariate||||-26.68|-73.72|
72502976|NCT01982630|144536221|OTHER||Difference of Least Squares Means|-31.2|||||TWO_SIDED|90.0|-56.59|-5.81|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline FPG as a covariate||||-5.81|-56.59|
72502977|NCT01982630|144536221|OTHER||Difference of Least Squares Means|-25.12|||||TWO_SIDED|90.0|-50.25|0.01|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline FPG as a covariate||||0.01|-50.25|
72621456|NCT02732145|144773198|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of the Anterior Commissure versus Interlabial Sulci in patients with vulvodynia and positive AWR?||||||1e-05|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Anterior Commissure versus Interlabial Sulci in patients with vulvodynia and positive AWR.||||0.00001
72621457|NCT02732145|144773198|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of the Anterior Commissure versus Labia Minora in patients with vulvodynia and positive AWR?||||||0|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Anterior Commissure versus Labia Minora in patients with vulvodynia and positive AWR.||||0.0000
72465858|NCT01917006|144454629|SUPERIORITY||Least square mean difference|0.01||||0.495||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 4 vs Placebo at Week 6||||0.495
72465859|NCT01917006|144454629|SUPERIORITY||Least square mean difference|0.0||||0.495||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 5 vs Placebo at Week 6||||0.495
72465860|NCT01917006|144454629|SUPERIORITY||Least square mean difference|0.23||||0.274||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 6 vs Placebo at Week 6||||0.274
72465861|NCT01917006|144454629|SUPERIORITY||Least square mean difference|0.22||||0.308||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 1 vs Placebo at Week 8||||0.308
72465862|NCT01917006|144454629|SUPERIORITY||Least square mean difference|0.34||||0.205||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 2 vs Placebo at Week 8||||0.205
72465863|NCT01917006|144454629|SUPERIORITY||Least square mean difference|-0.39||||0.849||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 3 vs Placebo at Week 8||||0.849
72465864|NCT01917006|144454629|SUPERIORITY||Least square mean difference|-0.07||||0.571||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 4 vs Placebo at Week 8||||0.571
72465865|NCT01917006|144454629|SUPERIORITY||Least square mean difference|-0.09||||0.592||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 5 vs Placebo at Week 8||||0.592
72465866|NCT01917006|144454629|SUPERIORITY||Least square mean difference|0.16||||0.34||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 6 vs Placebo at Week 8||||0.340
72465867|NCT01917006|144454629|SUPERIORITY||Least square mean difference|0.16||||0.36||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 1 vs Placebo at Week 10||||0.360
72502978|NCT01982630|144536221|OTHER||Difference of Least Squares Means|-6.08|||||TWO_SIDED|90.0|-17.31|5.14|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline FPG as a covariate||||5.14|-17.31|
72502979|NCT01982630|144536222|OTHER||Difference of Least Squares Means|-27.48|||||TWO_SIDED|90.0|-52.87|-2.09|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline FPG as a covariate||||-2.09|-52.87|
72502980|NCT01982630|144536222|OTHER||Difference of Least Squares Means|-30.59|||||TWO_SIDED|90.0|-55.72|-5.46|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline FPG as a covariate||||-5.46|-55.72|
72502981|NCT01982630|144536222|OTHER||Difference of Least Squares Means|3.11|||||TWO_SIDED|90.0|-8.11|14.34|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline FPG as a covariate||||14.34|-8.11|
72465868|NCT01917006|144454629|SUPERIORITY||Least square mean difference|0.35||||0.192||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 2 vs Placebo at Week 10||||0.192
72465869|NCT01917006|144454629|SUPERIORITY||Least square mean difference|-0.37||||0.843||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 3 vs Placebo at Week 10||||0.843
72502982|NCT01982630|144536223|OTHER||Difference of Least Squares Means|4.59|||||TWO_SIDED|90.0|-20.88|30.06|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline FPG as a covariate||||30.06|-20.88|
72502983|NCT01982630|144536223|OTHER||Difference of Least Squares Means|-5.42|||||TWO_SIDED|90.0|-30.68|19.85|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline FPG as a covariate||||19.85|-30.68|
72502984|NCT01982630|144536223|OTHER||Difference of Least Squares Means|10.01|||||TWO_SIDED|90.0|-1.77|21.78|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline FPG as a covariate||||21.78|-1.77|
72502985|NCT01982630|144536224|OTHER||Difference of Least Squares Means|-14.98|||||TWO_SIDED|90.0|-40.53|10.57|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline FPG as a covariate||||10.57|-40.53|
72502986|NCT01982630|144536224|OTHER||Difference of Least Squares Means|-14.5|||||TWO_SIDED|90.0|-39.77|10.76|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline FPG as a covariate||||10.76|-39.77|
72502987|NCT01982630|144536224|OTHER||Difference of Least Squares Means|-0.48|||||TWO_SIDED|90.0|-12.47|11.52|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline FPG as a covariate||||11.52|-12.47|
72502988|NCT01982630|144536225|OTHER||Difference of Least Squares Means|-43.68|||||TWO_SIDED|90.0|-65.81|-21.55|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline 24-hour WMG as a covariate||||-21.55|-65.81|
72502989|NCT01982630|144536225|OTHER||Difference of Least Squares Means|-47.4|||||TWO_SIDED|90.0|-69.35|-25.45|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline 24-hour WMG as a covariate||||-25.45|-69.35|
72502990|NCT01982630|144536225|OTHER||Difference of Least Squares Means|3.72|||||TWO_SIDED|90.0|-5.76|13.19|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline 24-hour WMG as a covariate||||13.19|-5.76|
72502991|NCT01982630|144536226|OTHER||Difference of Least Squares Means|-34.01|||||TWO_SIDED|90.0|-56.14|-11.88|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline 24-hour WMG as a covariate||||-11.88|-56.14|
72621458|NCT02732145|144773198|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of the Anterior Commissure versus Posterior Commissure in patients with vulvodynia and positive AWR?||||||0|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Anterior Commissure versus Posterior Commissure in patients with vulvodynia and positive AWR.||||0.0000
72394356|NCT01782222|144295588|SUPERIORITY_OR_OTHER||Least Square Mean|-0.22|STANDARD_ERROR_OF_MEAN|1.21||0.859|TWO_SIDED|95.0|-2.61|2.18|||ANCOVA|ANCOVA model for the change from Baseline to End of Maintenance containing treatment and disease stage as factors, and Baseline value as covariate.||||2.18|-2.61|0.859
72502992|NCT01982630|144536226|OTHER||Difference of Least Squares Means|-39.2|||||TWO_SIDED|90.0|-61.15|-17.26|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline 24-hour WMG as a covariate||||-17.26|-61.15|
72502993|NCT01982630|144536226|OTHER||Difference of Least Squares Means|5.2|||||TWO_SIDED|90.0|-4.28|14.67|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline 24-hour WMG as a covariate||||14.67|-4.28|
72502994|NCT01982630|144536227|OTHER||Difference of Least Squares Means|-23.73|||||TWO_SIDED|90.0|-45.89|-1.56|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline 24-hour WMG as a covariate||||-1.56|-45.89|
72394357|NCT01782222|144295589|SUPERIORITY_OR_OTHER||Least Square Mean|-7.29|STANDARD_ERROR_OF_MEAN|2.53||0.005|TWO_SIDED|95.0|-12.3|-2.28|||ANCOVA|ANCOVA model for the change from Baseline to End of Maintenance containing treatment and disease stage as factors, and Baseline value as covariate.||||-2.28|-12.30|0.005
72465870|NCT01917006|144454629|SUPERIORITY||Least square mean difference|-0.07||||0.572||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 4 vs Placebo at Week 10||||0.572
72502995|NCT01982630|144536227|OTHER||Difference of Least Squares Means|-33.95|||||TWO_SIDED|90.0|-55.93|-11.98|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline 24-hour WMG as a covariate||||-11.98|-55.93|
72502996|NCT01982630|144536227|OTHER||Difference of Least Squares Means|10.23|||||TWO_SIDED|90.0|0.56|19.89|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline 24-hour WMG as a covariate||||19.89|0.56|
72502997|NCT01982630|144536228|OTHER||Difference of Least Squares Means|-23.49|||||TWO_SIDED|90.0|-45.65|-1.32|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline 24-hour WMG as a covariate||||-1.32|-45.65|
72502998|NCT01982630|144536228|OTHER||Difference of Least Squares Means|-29.76|||||TWO_SIDED|90.0|-51.74|-7.79|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline 24-hour WMG as a covariate||||-7.79|-51.74|
72502999|NCT01982630|144536228|OTHER||Difference of Least Squares Means|6.27|||||TWO_SIDED|90.0|-3.39|15.93|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline 24-hour WMG as a covariate||||15.93|-3.39|
72504829|NCT00069121|144540545|SUPERIORITY||Hazard Ratio (HR)|0.8||||0.0038|TWO_SIDED|95.0|0.69|0.93||This test used a two-sided significance level of 5%.|Log Rank||The hazard ratio was calculated as XELOX versus 5-FU/LV arms.|||0.93|0.69|0.0038
72465871|NCT01917006|144454629|SUPERIORITY||Least square mean difference|-0.12||||0.628||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 5 vs Placebo at Week 10||||0.628
72465872|NCT01917006|144454629|SUPERIORITY||Least square mean difference|0.12||||0.38||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 6 vs Placebo at Week 10||||0.380
72465873|NCT02509312|144454649|SUPERIORITY|||||||0.34|||||||Wilcoxon (Mann-Whitney)|||||||0.34
72465874|NCT02509312|144454650|SUPERIORITY|||||||0.257|||||||Chi-squared|||||||.257
72465875|NCT02509312|144454651|SUPERIORITY|||||||0.085|||||||t-test, 2 sided|||||||0.085
72465876|NCT02509312|144454652|SUPERIORITY|||||||0.164|||||||Wilcoxon (Mann-Whitney)|||||||0.164
72394358|NCT01782222|144295589|SUPERIORITY_OR_OTHER||Least Square Mean|-6.06|STANDARD_ERROR_OF_MEAN|2.45||0.015|TWO_SIDED|95.0|-10.9|-1.21|||ANCOVA|ANCOVA model for the change from Baseline to End of Maintenance containing treatment and disease stage as factors, and Baseline value as covariate.||||-1.21|-10.90|0.015
72394359|NCT01782222|144295590|SUPERIORITY_OR_OTHER||Least Square Mean|-3.2|STANDARD_ERROR_OF_MEAN|2.46||0.2|TWO_SIDED|95.0|-8.17|1.76|||ANCOVA|ANCOVA model for the change from Baseline to End of Maintenance containing treatment and disease stage as factors, and Baseline value as covariate.||||1.76|-8.17|0.200
72465877|NCT02509312|144454653|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||||||1.000
72465878|NCT02509312|144454654|SUPERIORITY||Risk Difference (RD)|-0.27||||0.0367|TWO_SIDED|95.0|-0.52|-0.03|||Chi-squared|||||-0.03|-0.52|0.0367
72465879|NCT02509312|144454655|SUPERIORITY|||||||0.0231|||||||Wilcoxon (Mann-Whitney)|||||||0.0231
72465880|NCT02509312|144454656|SUPERIORITY|||||||0.467|||||||Wilcoxon (Mann-Whitney)|||||||0.467
72465881|NCT02509312|144454657|SUPERIORITY|||||||0.273|||||||Wilcoxon (Mann-Whitney)|||||||0.273
72465882|NCT02509312|144454658|SUPERIORITY|||||||0.0162||||||p-value for 12 hours post-op between-group comparison.|t-test, 2 sided|||||||0.0162
72465883|NCT02509312|144454660|SUPERIORITY|||||||0.048||||||p-value for 6 hours post-op between-group comparison.|Wilcoxon (Mann-Whitney)|||||||0.048
72465884|NCT01751165|144454701|NON_INFERIORITY_OR_EQUIVALENCE|Non-nferiority criteria: The upper limit (UL) of the 97.5% confidence interval (CI) for the anti-gE ELISA geometric mean concentration (GMC) ratio (0,2-month schedule over 0,6-month schedule) at one month post-dose 2 had to be below 1.5.|Adjusted GMC ratio|1.16|||||TWO_SIDED|97.5|0.98|1.39|||ANCOVA|||To demonstrate the non-inferiority in terms of anti-gE humoral immune response one month post-dose 2 given according to a 0,6-month schedule compared to a 0,2-month schedule.||1.39|0.98|
72465885|NCT01751165|144454701|NON_INFERIORITY_OR_EQUIVALENCE|Non-nferiority criteria: The upper limit (UL) of the 97.5% confidence interval (CI) for the anti-gE ELISA geometric mean concentration (GMC) ratio (0,2-month schedule over 0,6-month schedule) at one month post-dose 2 had to be below 1.5.|Adjusted GMC ratio|1.19|||||TWO_SIDED|97.5|0.93|1.53|||ANCOVA|||To demonstrate the non-inferiority in terms of anti-gE humoral immune response one month post-dose 2 given according to a 0,12-month schedule compared to a 0,2-month schedule.||1.53|0.93|
72465886|NCT00943722|144454759|NON_INFERIORITY|non-inferiority requires that the lower bound of two-sided 95% confidence interval (CI) of GMT ratio be greater than 0.67.|GMT ratio|1.9|||<|0.001|TWO_SIDED|95.0|1.7|2.14||one-sided tests of non-inferiority conducted at the alpha=0.025 level; model with a response of log individual titers and a fixed effect for comparison group|ANOVA|model with a response of log individual titers and a fixed effect for comparison group|GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 1) divided by GMT for 16- to 26-Year-Old Females (Lot 1)|Anti-HPV 6||2.14|1.70|< 0.001
72465887|NCT00943722|144454759|NON_INFERIORITY|Non-inferiority requires that the lower bound of two-sided 95% CI of GMT ratio be greater than 0.67|GMT ratio|1.83|||<|0.001|TWO_SIDED|95.0|1.63|2.06||one-sided tests of non-inferiority conducted at the alpha=0.025 level; model with a response of log individual titers and a fixed effect for comparison group|ANOVA|model with a response of log individual titers and a fixed effect for comparison group|GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 1) divided by GMT for 16- to 26-Year-Old Females (Lot 1)|Anti-HPV 11||2.06|1.63|< 0.001
72465888|NCT00943722|144454759|NON_INFERIORITY|Non-inferiority requires that the lower bound of two-sided 95% CI of GMT ratio be greater than 0.67|GMT ratio|1.98|||<|0.001|TWO_SIDED|95.0|1.77|2.22||one-sided tests of non-inferiority conducted at the alpha=0.025 level; model with a response of log individual titers and a fixed effect for comparison group|ANOVA|model with a response of log individual titers and a fixed effect for comparison group|GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 1) divided by GMT for 16- to 26-Year-Old Females (Lot 1)|Anti-HPV 16||2.22|1.77|< 0.001
72465889|NCT00943722|144454759|NON_INFERIORITY|non-inferiority requires that the lower bound of two-sided 95% CI of GMT ratio be greater than 0.67|GMT ratio|2.44|||<|0.001|TWO_SIDED|95.0|2.13|2.8||one-sided tests of non-inferiority conducted at the alpha=0.025 level; model with a response of log individual titers and a fixed effect for comparison group|ANOVA|model with a response of log individual titers and a fixed effect for comparison group|GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 1) divided by GMT for 16- to 26-Year-Old Females (Lot 1)|Anti-HPV 18||2.80|2.13|< 0.001
72504830|NCT00069121|144540546|OTHER|Descriptive analysis only.|Hazard Ratio (HR)|0.78||||0.0015|TWO_SIDED|95.0|0.67|0.91|||Log Rank||The hazard ratio was calculated as XELOX versus 5-FU/LV arms.|||0.91|0.67|0.0015
72465890|NCT00943722|144454759|NON_INFERIORITY|non-inferiority requires that the lower bound of two-sided 95% CI of GMT ratio be greater than 0.67|GMT ratio|2.51|||<|0.001|TWO_SIDED|95.0|2.21|2.85||one-sided tests of non-inferiority conducted at the alpha=0.025 level; model with a response of log individual titers and a fixed effect for comparison group|ANOVA|model with a response of log individual titers and a fixed effect for comparison group|GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 1) divided by GMT for 16- to 26-Year-Old Females (Lot 1)|Anti-HPV 31||2.85|2.21|< 0.001
72503000|NCT01273818|144536286|SUPERIORITY_OR_OTHER||Fscher exact test|||||0.198|TWO_SIDED||||||Fisher Exact||we did not need an estimation parameter such as odds or relative risk because of our experimental design and hypothesis of this study.|"Comparison Group Selection: our primary outcome is infection positive or negativeso, we compared the frequencies of being positive infections for these three groups. Our null hypothesis is  positive infection frequencies are same for three groups. We calculated post-hoc power for this design and found 0.99 for the percentages which shows positive infections respectively for Topical Gentamicin, cefazoline iv and topical gentamicin and iv cefazolin; 2.3%, 3.1% and 0%."||||0.198
72503001|NCT03815175|144536287|NON_INFERIORITY|"H0: Death/(MI\[1m-DAPT\]) - Death/(MI \[XIENCE V USA\]) ≥ δ HA: Death/MI(\[1m-DAPT\]) - Death/(MI \[XIENCE V USA: NCT00676520\]) \< δ~Where δ is the non-inferiority margin. The test will be carried out with a one-sided significance level of 0.025 and a non-inferiority margin (δ) of 2.5%."||||||0.0005|||||||Farrington-Manning method|||||||0.0005
72503002|NCT03815175|144536290|SUPERIORITY|"H0: B (1m-DAPT) - B (XIENCE V USA) ≥ 0 HA: B (1m-DAPT) - B (XIENCE V USA: NCT00676520) \< 0~B 1m-DAPT and B XIENCE V USA are bleeding rates (BARC type 2-5) between 1-month and 6-month follow-up for the pooled 1-month DAPT arm and XIENCE V USA historical control, respectively."||||||0.1888|||||||Farrington and Manning method|||||||0.1888
72621459|NCT02732145|144773198|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Interlabial Sulci versus Labia Minora in patients with vulvodynia and positive AWR?||||||0.0008|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Interlabial Sulci versus Labia Minora in patients with vulvodynia and positive AWR.||||0.0008
72621460|NCT02732145|144773198|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Interlabial Sulci versus Posterior Commissure in patients with vulvodynia and positive AWR?||||||0|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Interlabial Sulci versus Posterior Commissure in patients with vulvodynia and positive AWR.||||0.0000
72394360|NCT01782222|144295590|SUPERIORITY_OR_OTHER||Least Square Mean|-3.04|STANDARD_ERROR_OF_MEAN|2.55||0.239|TWO_SIDED|95.0|-8.19|2.1|||ANCOVA|ANCOVA model for the change from Baseline to End of Maintenance containing treatment and disease stage as factors, and Baseline value as covariate.||||2.10|-8.19|0.239
72394361|NCT01782222|144295591|SUPERIORITY_OR_OTHER||Least Square Mean|-2.09|STANDARD_ERROR_OF_MEAN|3.23||0.519|TWO_SIDED|95.0|-8.48|4.31|||ANCOVA|ANCOVA model for the change from Baseline to End of Maintenance containing treatment and disease stage as factors, and Baseline value as covariate.||||4.31|-8.48|0.519
72503003|NCT02513446|144536365|SUPERIORITY_OR_OTHER||Adjusted gMean T/R ratio|176.1|||||TWO_SIDED|90.0|160.5|193.2|||ANOVA|Analysis of variance (ANOVA) on the logarithmic scale; Fixed effects: sequence, period and treatment; Random effects: subjects within sequences|Ratio of the treatment adjusted geometric means (gMean) of (T) versus (R).|||193.2|160.5|
72503004|NCT02513446|144536366|SUPERIORITY_OR_OTHER||Adjusted gMean T/R ratio|136.5|||||TWO_SIDED|90.0|109.9|169.4|||ANOVA|Analysis of variance (ANOVA) on the logarithmic scale; Fixed effects: sequence, period and treatment; Random effects: subjects within sequences|Ratio of the treatment adjusted geometric means (gMean) of (T) versus (R).|||169.4|109.9|
72394362|NCT01782222|144295591|SUPERIORITY_OR_OTHER||Least Square Mean|-5.06|STANDARD_ERROR_OF_MEAN|3.15||0.111|TWO_SIDED|95.0|-11.29|1.17|||ANCOVA|ANCOVA model for the change from Baseline to End of Maintenance containing treatment and disease stage as factors, and Baseline value as covariate.||||1.17|-11.29|0.111
72504831|NCT00069121|144540548|OTHER|Descriptive analysis only.|Hazard Ratio (HR)|0.83||||0.0367|TWO_SIDED|95.0|0.7|0.99|||Log Rank||The hazard ratio was calculated as XELOX versus 5-FU/LV arms.|||0.99|0.70|0.0367
72465891|NCT00943722|144454759|NON_INFERIORITY|non-inferiority requires that the lower bound of two-sided 95% CI of GMT ratio be greater than 0.67|GMT ratio|2.1|||<|0.001|TWO_SIDED|95.0|1.87|2.36||one-sided tests of non-inferiority conducted at the alpha=0.025 level; model with a response of log individual titers and a fixed effect for comparison group|ANOVA|model with a response of log individual titers and a fixed effect for comparison group|GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 1) divided by GMT for 16- to 26-Year-Old Females (Lot 1)|Anti-HPV 33||2.36|1.87|< 0.001
72465892|NCT00943722|144454759|NON_INFERIORITY|non-inferiority requires that the lower bound of two-sided 95% CI of GMT ratio be greater than 0.67|GMT ratio|2.62|||<|0.001|TWO_SIDED|95.0|2.27|3.03||one-sided tests of non-inferiority conducted at the alpha=0.025 level; model with a response of log individual titers and a fixed effect for comparison group|ANOVA|model with a response of log individual titers and a fixed effect for comparison group|GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 1) divided by GMT for 16- to 26-Year-Old Females (Lot 1)|Anti-HPV 45||3.03|2.27|< 0.001
72465893|NCT00943722|144454759|NON_INFERIORITY|non-inferiority requires that the lower bound of two-sided 95% CI of GMT ratio be greater than 0.67|GMT ratio|2.22|||<|0.001|TWO_SIDED|95.0|1.97|2.51||one-sided tests of non-inferiority conducted at the alpha=0.025 level; model with a response of log individual titers and a fixed effect for comparison group|ANOVA|model with a response of log individual titers and a fixed effect for comparison group|GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 1) divided by GMT for 16- to 26-Year-Old Females (Lot 1)|Anti-HPV 52||2.51|1.97|< 0.001
72465894|NCT00943722|144454759|NON_INFERIORITY|non-inferiority requires that the lower bound of two-sided 95% CI of GMT ratio be greater than 0.67|GMT ratio|2.18|||<|0.001|TWO_SIDED|95.0|1.93|2.45||one-sided tests of non-inferiority conducted at the alpha=0.025 level; model with a response of log individual titers and a fixed effect for comparison group|ANOVA|model with a response of log individual titers and a fixed effect for comparison group|GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 1) divided by GMT for 16- to 26-Year-Old Females (Lot 1)|Anti-HPV 58||2.45|1.93|< 0.001
72465895|NCT00943722|144454760|NON_INFERIORITY|non-inferiority requires that the lower bound of two-sided 95% CI of GMT ratio be greater than 0.67|GMT ratio|2.31|||<|0.001|TWO_SIDED|95.0|2.07|2.59||one-sided tests of non-inferiority conducted at the alpha=0.025 level; model with a response of log individual titers and a fixed effect for comparison group|ANOVA|model with a response of log individual titers and a fixed effect for comparison group|GMT ratio = GMT for 9- to 15-Year-Old males (Lot 1) divided by GMT for 16- to 26-Year-Old Females (Lot 1)|Anti-HPV 6||2.59|2.07|< 0.001
72465896|NCT00943722|144454760|NON_INFERIORITY|non-inferiority requires that the lower bound of two-sided 95% CI of GMT ratio be greater than 0.67|GMT ratio|2.1|||<|0.001|TWO_SIDED|95.0|1.88|2.36||one-sided tests of non-inferiority conducted at the alpha=0.025 level; model with a response of log individual titers and a fixed effect for comparison group|ANOVA|model with a response of log individual titers and a fixed effect for comparison group|GMT ratio = GMT for 9- to 15-Year-Old Males (Lot 1) divided by GMT for 16- to 26-Year-Old Females (Lot 1)|Anti-HPV 11||2.36|1.88|< 0.001
72465897|NCT00943722|144454760|NON_INFERIORITY|non-inferiority requires that the lower bound of two-sided 95% CI of GMT ratio be greater than 0.67|GMT ratio|2.45|||<|0.001|TWO_SIDED|95.0|2.19|2.74||one-sided tests of non-inferiority conducted at the alpha=0.025 level; model with a response of log individual titers and a fixed effect for comparison group|ANOVA|model with a response of log individual titers and a fixed effect for comparison group|GMT ratio = GMT for 9- to 15-Year-Old Males (Lot 1) divided by GMT for 16- to 26-Year-Old Females (Lot 1)|Anti-HPV 16||2.74|2.19|< 0.001
72503005|NCT02513446|144536367|SUPERIORITY_OR_OTHER||Adjusted gMean T/R ratio|174.8|||||TWO_SIDED|90.0|159.1|192.0|||ANOVA|Analysis of variance (ANOVA) on the logarithmic scale; Fixed effects: sequence, period and treatment; Random effects: subjects within sequences|Ratio of the treatment adjusted geometric means (gMean) of (T) versus (R).|||192.0|159.1|
72503006|NCT00002850|144536422|SUPERIORITY_OR_OTHER|||||||0.218|||||||Fisher Exact|Target accrual=70 patients per arm to provide 92% power to detect a difference of 0.31 vs. 0.08 in the proportion of patients with serious infection.||"H0: There is no significant difference in the incidence of severe bacterial infections among all three arms during the first 2 months of treatment at the two-sided 0.05 significance level.~Ha: There is a significant difference in the incidence of severe bacterial infections among all three arms during the first 2 months of treatment at the two-sided 0.05 significance level."||||0.218
72621461|NCT02732145|144773198|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Labia Minora versus Posterior Commissure in patients with vulvodynia and positive AWR?||||||0|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Labia Minora versus Posterior Commissure in patients with vulvodynia and positive AWR.||||0.0000
72503007|NCT01200433|144536423|NON_INFERIORITY_OR_EQUIVALENCE|"We tested a joint hypothesis that dexmedetomidine was noninferior to propofol both in terms of cerebral blood flow velocity and brain oxygenation during DBS surgery.~A total of 44 patients provided a 90% power at the 0.05 significance level to detect noninferiority of dexmedetomidine to propofol using a noninferiority ratio of geometric means of 0.80, assuming a coefficient of variation of 25% for each of the 2 primary outcomes. Both outcomes were expected to follow a log-normal distribution."|Ratio of Geometric Means|0.94||||0.011|TWO_SIDED|90.0|0.84|1.05|||t-test, 1 sided||Dexmedetomidine vs. propofol|||1.05|0.84|0.011
72621462|NCT02732145|144773198|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of the Anterior Commissure versus Interlabial Sulci in patients with impaired vulvar skin and positive AWR?||||||0.0005|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Anterior Commissure versus Interlabial Sulci in patients with impaired vulvar skin and positive AWR.||||0.0005
72394363|NCT01782222|144295592|SUPERIORITY_OR_OTHER||Least Square Mean|-3.62|STANDARD_ERROR_OF_MEAN|1.9||0.06|TWO_SIDED|95.0|-7.39|0.15|||ANCOVA|ANCOVA model for the change from Baseline to End of Treatment containing treatment and disease stage as factors, and Baseline value as covariate.||||0.15|-7.39|0.060
72465898|NCT00943722|144454760|NON_INFERIORITY|non-inferiority requires that the lower bound of two-sided 95% CI of GMT ratio be greater than 0.67|GMT ratio|3.2|||<|0.001|TWO_SIDED|95.0|2.8|3.65||one-sided tests of non-inferiority conducted at the alpha=0.025 level; model with a response of log individual titers and a fixed effect for comparison group|ANOVA|model with a response of log individual titers and a fixed effect for comparison group|GMT ratio = GMT for 9- to 15-Year-Old Males (Lot 1) divided by GMT for 16- to 26-Year-Old Females (Lot 1)|Anti-HPV 18||3.65|2.80|< 0.001
72465899|NCT00943722|144454760|NON_INFERIORITY|non-inferiority requires that the lower bound of two-sided 95% CI of GMT ratio be greater than 0.67|GMT ratio|2.95|||<|0.001|TWO_SIDED|95.0|2.6|3.34||one-sided tests of non-inferiority conducted at the alpha=0.025 level; model with a response of log individual titers and a fixed effect for comparison group|ANOVA|model with a response of log individual titers and a fixed effect for comparison group|GMT ratio = GMT for 9- to 15-Year-Old Males (Lot 1) divided by GMT for 16- to 26-Year-Old Females (Lot 1)|Anti-HPV 31||3.34|2.60|< 0.001
72465900|NCT00943722|144454760|NON_INFERIORITY|non-inferiority requires that the lower bound of two-sided 95% CI of GMT ratio be greater than 0.67|GMT ratio|2.57|||<|0.001|TWO_SIDED|95.0|2.29|2.88||one-sided tests of non-inferiority conducted at the alpha=0.025 level; model with a response of log individual titers and a fixed effect for comparison group|ANOVA|model with a response of log individual titers and a fixed effect for comparison group|GMT ratio = GMT for 9- to 15-Year-Old Males (Lot 1) divided by GMT for 16- to 26-Year-Old Females (Lot 1)|Anti-HPV 33||2.88|2.29|< 0.001
72465901|NCT00943722|144454760|NON_INFERIORITY|non-inferiority requires that the lower bound of two-sided 95% CI of GMT ratio be greater than 0.67|GMT ratio|3.33|||<|0.001|TWO_SIDED|95.0|2.89|3.84||one-sided tests of non-inferiority conducted at the alpha=0.025 level; model with a response of log individual titers and a fixed effect for comparison group|ANOVA|model with a response of log individual titers and a fixed effect for comparison group|GMT ratio = GMT for 9- to 15-Year-Old Males (Lot 1) divided by GMT for 16- to 26-Year-Old Females (Lot 1)|Anti-HPV 45||3.84|2.89|< 0.001
72465902|NCT00943722|144454760|NON_INFERIORITY|non-inferiority requires that the lower bound of two-sided 95% CI of GMT ratio be greater than 0.67|GMT ratio|2.47|||<|0.001|TWO_SIDED|95.0|2.19|2.79||one-sided tests of non-inferiority conducted at the alpha=0.025 level; model with a response of log individual titers and a fixed effect for comparison group|ANOVA|model with a response of log individual titers and a fixed effect for comparison group|GMT ratio = GMT for 9- to 15-Year-Old Males (Lot 1) divided by GMT for 16- to 26-Year-Old Females (Lot 1)|Anti-HPV 52||2.79|2.19|< 0.001
72465903|NCT00943722|144454760|NON_INFERIORITY|non-inferiority requires that the lower bound of two-sided 95% CI of GMT ratio be greater than 0.67|GMT ratio|2.66|||<|0.001|TWO_SIDED|95.0|2.37|2.98||one-sided tests of non-inferiority conducted at the alpha=0.025 level; model with a response of log individual titers and a fixed effect for comparison group|ANOVA|model with a response of log individual titers and a fixed effect for comparison group|GMT ratio = GMT for 9- to 15-Year-Old Males (Lot 1) divided by GMT for 16- to 26-Year-Old Females (Lot 1)|Anti-HPV 58||2.98|2.37|< 0.001
72465904|NCT00943722|144454761|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the ratio of the GMTs be entirely contained within the interval (0.5, 2.0)|GMT ratio|0.97|||||TWO_SIDED|95.0|0.88|1.08|||||GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 1) divided by GMT for 9- to 15-Year-Old Females (Lot 2)|Anti-HPV 6||1.08|0.88|
72465905|NCT00943722|144454761|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the ratio of the GMTs be entirely contained within the interval (0.5, 2.0).|GMT ratio|1.03|||||TWO_SIDED|95.0|0.93|1.16|||||GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 1) divided by GMT for 9- to 15-Year-Old Females (Lot 3)|Anti-HPV 6||1.16|0.93|
72465906|NCT00943722|144454761|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the ratio of the GMTs be entirely contained within the interval (0.5, 2.0).|GMT ratio|1.06|||||TWO_SIDED|95.0|0.95|1.19|||||GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 2) divided by GMT for 9- to 15-Year-Old Females (Lot 3)|Anti-HPV 6||1.19|0.95|
72503008|NCT01200433|144536424|NON_INFERIORITY_OR_EQUIVALENCE|"We tested a joint hypothesis that dexmedetomidine was noninferior to propofol both in terms of cerebral blood flow velocity and brain oxygenation during DBS surgery.~A total of 44 patients provided a 90% power at the 0.05 significance level to detect noninferiority of dexmedetomidine to propofol using a noninferiority ratio of geometric means of 0.80, assuming a coefficient of variation of 25% for each of the 2 primary outcomes. Both outcomes were expected to follow a log-normal distribution."|Ratio of Geometric Means|0.99|||<|0.001|TWO_SIDED|90.0|0.96|1.02|||t-test, 1 sided||Dexmedetomidine vs. propofol|||1.02|0.96|< 0.001
72503009|NCT01200433|144536426|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|1.0|||<|0.001|TWO_SIDED|99.0|0.0|2.0|||Wilcoxon (Mann-Whitney)|||||2|0|<0.001
72394364|NCT01782222|144295592|SUPERIORITY_OR_OTHER||Least Square Mean|-3.88|STANDARD_ERROR_OF_MEAN|1.8||0.034|TWO_SIDED|95.0|-7.46|-0.3|||ANCOVA|ANCOVA model for the change from Baseline to End of Treatment containing treatment and disease stage as factors, and Baseline value as covariate.||||-0.30|-7.46|0.034
72465907|NCT00943722|144454761|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the ratio of the GMTs be entirely contained within the interval (0.5, 2.0).|GMT ratio|1.0|||||TWO_SIDED|95.0|0.9|1.11|||||GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 1) divided by GMT for 9- to 15-Year-Old Females (Lot 2)|Anti-HPV 11||1.11|0.90|
72465908|NCT00943722|144454761|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the ratio of the GMTs be entirely contained within the interval (0.5, 2.0).|GMT ratio|1.07|||||TWO_SIDED|95.0|0.95|1.2|||||GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 1) divided by GMT for 9- to 15-Year-Old Females (Lot 3)|Anti-HPV 11||1.20|0.95|
72465909|NCT00943722|144454761|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the ratio of the GMTs be entirely contained within the interval (0.5, 2.0).|GMT ratio|1.07|||||TWO_SIDED|95.0|0.95|1.2|||||GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 2) divided by GMT for 9- to 15-Year-Old Females (Lot 3)|Anti-HPV 11||1.20|0.95|
72465910|NCT00943722|144454761|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the ratio of the GMTs be entirely contained within the interval (0.5, 2.0).|GMT ratio|0.96|||||TWO_SIDED|95.0|0.86|1.06|||||GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 1) divided by GMT for 9- to 15-Year-Old Females (Lot 2)|Anti-HPV 16||1.06|0.86|
72465911|NCT00943722|144454761|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the ratio of the GMTs be entirely contained within the interval (0.5, 2.0)|GMT ratio|1.0|||||TWO_SIDED|95.0|0.9|1.12|||||GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 1) divided by GMT for 9- to 15-Year-Old Females (Lot 3)|Anti-HPV 16||1.12|0.90|
72465912|NCT00943722|144454761|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the ratio of the GMTs be entirely contained within the interval (0.5, 2.0)|GMT ratio|1.05|||||TWO_SIDED|95.0|0.94|1.17|||||GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 2) divided by GMT for 9- to 15-Year-Old Females (Lot 3)|Anti-HPV 16||1.17|0.94|
72465913|NCT00943722|144454761|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the ratio of the GMTs be entirely contained within the interval (0.5, 2.0)|GMT ratio|1.0|||||TWO_SIDED|95.0|0.89|1.14|||||GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 1) divided by GMT for 9- to 15-Year-Old Females (Lot 2)|Anti-HPV 18||1.14|0.89|
72503010|NCT01200433|144536427|SUPERIORITY_OR_OTHER||Ratio of Geometric Means|1.0||||0.91|TWO_SIDED|99.0|0.86|1.18|||Wilcoxon (Mann-Whitney)|||||1.18|0.86|0.91
72503011|NCT01200433|144536429|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-1.9||||0.02|TWO_SIDED|99.0|-4.1|0.2|||Wilcoxon (Mann-Whitney)|||||0.2|-4.1|0.02
72503012|NCT01200433|144536430|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0|||>|0.99|TWO_SIDED|99.0|0.0|0.0|||Wilcoxon (Mann-Whitney)|||||0|0|>0.99
72503013|NCT01416181|144536432|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.86||||0.2866|TWO_SIDED|95.0|0.66|1.13|||Regression, Logistic|Based on logistic regression, adjusted for Baseline EDSS (\<=5.5 or \>=6) and/or T25FW and/or 9HPT (either hand).|active/placebo|Confirmed progressors on ≥ 1 of EDSS, T25FW, or 9HPT at 2 years||1.13|0.66|0.2866
72503014|NCT01416181|144536432|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.06||||0.753|TWO_SIDED|95.0|0.74|1.53|||Regression, Logistic|Based on logistic regression, adjusted for Baseline EDSS (\<=5.5 or \>=6) and/or T25FW and/or 9HPT (either hand).|active/placebo|Confirmed progressors on EDSS||1.53|0.74|0.7530
72503015|NCT01416181|144536432|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.98||||0.9137|TWO_SIDED|95.0|0.74|1.3|||Regression, Logistic|Based on logistic regression, adjusted for Baseline EDSS (\<=5.5 or \>=6) and/or T25FW and/or 9HPT (either hand).|active/placebo|Confirmed progressors on T25FW||1.30|0.74|0.9137
72503016|NCT01416181|144536432|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.56||||0.0012|TWO_SIDED|95.0|0.4|0.8|||Regression, Logistic|Based on logistic regression, adjusted for Baseline EDSS (\<=5.5 or \>=6) and/or T25FW and/or 9HPT (either hand).||Confirmed progressors on 9HPT (either hand)||0.80|0.40|0.0012
72503017|NCT01416181|144536432|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.72||||0.1251|TWO_SIDED|95.0|0.48|1.09|||Regression, Logistic|Based on logistic regression, adjusted for Baseline EDSS (\<=5.5 or \>=6) and/or T25FW and/or 9HPT (either hand).||Confirmed progressors on 9HPT (dominant hand)||1.09|0.48|0.1251
72503018|NCT01416181|144536432|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.58||||0.0091|TWO_SIDED|95.0|0.39|0.87|||Regression, Logistic|Based on logistic regression, adjusted for Baseline EDSS (\<=5.5 or \>=6) and/or T25FW and/or 9HPT (either hand).||Confirmed progressors on 9HPT (non-dominant hand)||0.87|0.39|0.0091
72503019|NCT01416181|144536434|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.16||||0.4369|TWO_SIDED|95.0|0.8|1.7|||Regression, Logistic|Based on logistic regression, adjusted for baseline EDSS (\<=5.5 or \>=6) and T25FW.|active/placebo|||1.70|0.80|0.4369
72503020|NCT01416181|144536435|SUPERIORITY_OR_OTHER|||||||0.5409|||||||ANCOVA|p-value for comparison between the active and placebo groups at Week 96 is based on ANCOVA model, adjusted for BL EDSS (\<=5.5 or \>=6) and BL MSWS-12.||||||0.5409
72503021|NCT01416181|144536436|SUPERIORITY_OR_OTHER|||||||0.2586|||||||ANCOVA|p-value for comparison between active and placebo groups at Week 96 is based on ANCOVA model, adjusted for BL EDSS (\<=5.5 or \>=6) and BL ABILHAND.||||||0.2586
72503022|NCT01416181|144536437|SUPERIORITY_OR_OTHER|||||||0.1529|||||||ANCOVA|p-value for comparison between active \& placebo groups at Wk 96 based on ANCOVA model, adjusted for BL EDSS (≤5.5 or ≥6) \& BL MSIS-29 physical score.||||||0.1529
72503023|NCT01416181|144536438|SUPERIORITY_OR_OTHER|||||||0.2424||||||natalizumab participants had a baseline after 6 months of treatment and the placebo-to-natalizumab group had a baseline of initiation of treatment|ANCOVA|p-value for comparison between active and placebo groups at Week 96 is based on ANCOVA model, adjusted for BL EDSS (\<=5.5 or \>=6) and BL brain volume.||Only participants with BL brain volume are included in the p-value calculation.||||0.2424
72503024|NCT01416181|144536439|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.78||||0.1052|TWO_SIDED|95.0|0.58|1.05|||Regression, Logistic|Based on logistic regression, adjusted for baseline EDSS (\<=5.5 or \>=6).||||1.05|0.58|0.1052
72503025|NCT01416181|144536440|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.67||||0.0205|TWO_SIDED|95.0|0.47|0.94|||Regression, Logistic|Based on logistic regression, adjusted for Baseline EDSS (\<=5.5 or \>=6) and/or T25FW and/or 9HPT (either hand).|active/placebo|Confirmed progressors on ≥ 1 of EDSS, T25FW, or 9HPT at 156 weeks||0.94|0.47|0.0205
72503026|NCT01416181|144536440|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.73||||0.1305|TWO_SIDED|95.0|0.48|1.1|||Regression, Logistic|Based on logistic regression, adjusted for Baseline EDSS (\<=5.5 or \>=6) and/or T25FW and/or 9HPT (either hand).|active/placebo|Confirmed progressors on EDSS at 156 weeks||1.10|0.48|0.1305
72564325|NCT00483548|144660354|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|0.0|STANDARD_ERROR_OF_MEAN|0.01||0.9097||95.0|-0.03|0.03|||ANCOVA|||Incapacitation score: Week 4; Observed cases; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.||0.03|-0.03|0.9097
72394365|NCT01782222|144295593|SUPERIORITY_OR_OTHER||Least Square Mean|-0.38|STANDARD_ERROR_OF_MEAN|0.39||0.334|TWO_SIDED|95.0|-1.16|0.4|||ANCOVA|ANCOVA model for the change from Baseline to End of Maintenance containing treatment and disease stage as factors, and Baseline value as covariate.||||0.40|-1.16|0.334
72503027|NCT01416181|144536440|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.8||||0.1988|TWO_SIDED|95.0|0.57|1.12|||Regression, Logistic|Based on logistic regression, adjusted for Baseline EDSS (\<=5.5 or \>=6) and/or T25FW and/or 9HPT (either hand).|active/placebo|Confirmed progressors on T25FW at 156 weeks||1.12|0.57|0.1988
72503028|NCT01416181|144536440|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.59||||0.0093|TWO_SIDED|95.0|0.39|0.88|||Regression, Logistic|Based on logistic regression, adjusted for Baseline EDSS (\<=5.5 or \>=6) and/or T25FW and/or 9HPT (either hand).|active/placebo|Confirmed progressors on 9HPT (either hand) at 156 weeks||0.88|0.39|0.0093
72503029|NCT01416181|144536440|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.63||||0.054|TWO_SIDED|95.0|0.39|1.01|||Regression, Logistic|Based on logistic regression, adjusted for Baseline EDSS (\<=5.5 or \>=6) and/or T25FW and/or 9HPT (either hand).|active/placebo|Confirmed progressors onm 9HPT (dominant hand) at 156 weeks||1.01|0.39|0.0540
72564326|NCT00483548|144660354|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|0.0|STANDARD_ERROR_OF_MEAN|0.02||0.9864||95.0|-0.04|0.04|||ANCOVA|||Incapacitation score: Week 6; Observed cases; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.||0.04|-0.04|0.9864
72564327|NCT00483548|144660355|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|1.52|STANDARD_ERROR_OF_MEAN|2.54||0.5519||95.0|-3.5|6.53|||ANCOVA|||Total Q-LES-Q: Week 6; Observed cases; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.||6.53|-3.50|0.5519
72564328|NCT00483548|144660355|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|-0.09|STANDARD_ERROR_OF_MEAN|0.13||0.5238||95.0|-0.35|0.18|||ANCOVA|||Medications: Week 6; Observed cases; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.||0.18|-0.35|0.5238
72465914|NCT00943722|144454761|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the ratio of the GMTs be entirely contained within the interval (0.5, 2.0)|GMT ratio|1.11|||||TWO_SIDED|95.0|0.98|1.26|||||GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 1) divided by GMT for 9- to 15-Year-Old Females (Lot 3)|Anti-HPV 18||1.26|0.98|
72465915|NCT00943722|144454761|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the ratio of the GMTs be entirely contained within the interval (0.5, 2.0)|GMT ratio|1.11|||||TWO_SIDED|95.0|0.97|1.26|||||GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 2) divided by GMT for 9- to 15-Year-Old Females (Lot 3)|Anti-HPV 18||1.26|0.97|
72465916|NCT00943722|144454761|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the ratio of the GMTs be entirely contained within the interval (0.5, 2.0)|GMT ratio|1.0|||||TWO_SIDED|95.0|0.89|1.13|||||GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 1) divided by GMT for 9- to 15-Year-Old Females (Lot 2)|Anti-HPV 31||1.13|0.89|
72465917|NCT00943722|144454761|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the ratio of the GMTs be entirely contained within the interval (0.5, 2.0)|GMT ratio|1.02|||||TWO_SIDED|95.0|0.91|1.16|||||GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 1) divided by GMT for 9- to 15-Year-Old Females (Lot 3)|Anti-HPV 31||1.16|0.91|
72465918|NCT00943722|144454761|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the ratio of the GMTs be entirely contained within the interval (0.5, 2.0)|GMT ratio|1.02|||||TWO_SIDED|95.0|0.9|1.15|||||GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 2) divided by GMT for 9- to 15-Year-Old Females (Lot 3)|Anti-HPV 31||1.15|0.90|
72465919|NCT00943722|144454761|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the ratio of the GMTs be entirely contained within the interval (0.5, 2.0)|GMT ratio|1.05|||||TWO_SIDED|95.0|0.94|1.16|||||GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 1) divided by GMT for 9- to 15-Year-Old Females (Lot 2)|Anti-HPV 33||1.16|0.94|
72465920|NCT00943722|144454761|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the ratio of the GMTs be entirely contained within the interval (0.5, 2.0)|GMT ratio|1.05|||||TWO_SIDED|95.0|0.94|1.17|||||GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 1) divided by GMT for 9- to 15-Year-Old Females (Lot 3)|Anti-HPV 33||1.17|0.94|
72465921|NCT00943722|144454761|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the ratio of the GMTs be entirely contained within the interval (0.5, 2.0)|GMT ratio|1.01|||||TWO_SIDED|95.0|0.9|1.12|||||GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 2) divided by GMT for 9- to 15-Year-Old Females (Lot 3)|Anti-HPV 33||1.12|0.90|
72503030|NCT01416181|144536440|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.7||||0.141|TWO_SIDED|95.0|0.44|1.12|||Regression, Logistic|Based on logistic regression, adjusted for Baseline EDSS (\<=5.5 or \>=6) and/or T25FW and/or 9HPT (either hand).|active/placebo|Confirmed progressors on 9HPT (non-dominant hand) at 156 weeks||1.12|0.44|0.1410
72503031|NCT01416181|144536441|SUPERIORITY_OR_OTHER|||||||0.0273|||||||ANCOVA|p-value for comparison between active and placebo at Week 156 based on ANCOVA model, adjusted for BL EDSS (\<=5.5 or\>=6) and BL T25FW.||Week 156||||0.0273
72503032|NCT01416181|144536441|SUPERIORITY_OR_OTHER|||||||0.1974|||||||ANCOVA|p-value for comparison between active and placebo at Week 156 based on ANCOVA model, adjusted for BL EDSS (\<=5.5 or\>=6) and BL T25FW.||CP Group: Week 156||||0.1974
72503033|NCT01416181|144536441|SUPERIORITY_OR_OTHER|||||||0.2506|||||||ANCOVA|p-value for comparison between active and placebo at Week 156 based on ANCOVA model, adjusted for BL EDSS (\<=5.5 or\>=6) and BL T25FW.||NP Group: Week 156||||0.2506
72621463|NCT02732145|144773198|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of the Anterior Commissure versus Labia Minora in patients with impaired vulvar skin and positive AWR?||||||0|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Anterior Commissure versus Labia Minora in patients with impaired vulvar skin and positive AWR.||||0.0000
72465922|NCT00943722|144454761|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the ratio of the GMTs be entirely contained within the interval (0.5, 2.0)|GMT ratio|0.84|||||TWO_SIDED|95.0|0.73|0.95|||||GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 1) divided by GMT for 9- to 15-Year-Old Females (Lot 2)|Anti-HPV 45||0.95|0.73|
72465923|NCT00943722|144454761|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the ratio of the GMTs be entirely contained within the interval (0.5, 2.0)|GMT ratio|1.04|||||TWO_SIDED|95.0|0.91|1.18|||||GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 1) divided by GMT for 9- to 15-Year-Old Females (Lot 3)|Anti-HPV 45||1.18|0.91|
72465924|NCT00943722|144454761|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the ratio of the GMTs be entirely contained within the interval (0.5, 2.0)|GMT ratio|1.24|||||TWO_SIDED|95.0|1.08|1.42|||||GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 2) divided by GMT for 9- to 15-Year-Old Females (Lot 3)|Anti-HPV 45||1.42|1.08|
72465925|NCT00943722|144454761|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the ratio of the GMTs be entirely contained within the interval (0.5, 2.0)|GMT ratio|0.92|||||TWO_SIDED|95.0|0.83|1.03|||||GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 1) divided by GMT for 9- to 15-Year-Old Females (Lot 2)|Anti-HPV 52||1.03|0.83|
72465926|NCT00943722|144454761|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the ratio of the GMTs be entirely contained within the interval (0.5, 2.0)|GMT ratio|0.95|||||TWO_SIDED|95.0|0.85|1.07|||||GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 1) divided by GMT for 9- to 15-Year-Old Females (Lot 3)|Anti-HPV 52||1.07|0.85|
72465927|NCT00943722|144454761|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the ratio of the GMTs be entirely contained within the interval (0.5, 2.0)|GMT ratio|1.03|||||TWO_SIDED|95.0|0.92|1.16|||||GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 2) divided by GMT for 9- to 15-Year-Old Females (Lot 3)|Anti-HPV 52||1.16|0.92|
72465928|NCT00943722|144454761|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the ratio of the GMTs be entirely contained within the interval (0.5, 2.0)|GMT ratio|0.95|||||TWO_SIDED|95.0|0.86|1.06|||||GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 1) divided by GMT for 9- to 15-Year-Old Females (Lot 2)|Anti-HPV 58||1.06|0.86|
72465929|NCT00943722|144454761|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the ratio of the GMTs be entirely contained within the interval (0.5, 2.0)|GMT ratio|1.07|||||TWO_SIDED|95.0|0.96|1.2|||||GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 1) divided by GMT for 9- to 15-Year-Old Females (Lot 3)|Anti-HPV 58||1.20|0.96|
72503034|NCT01416181|144536442|SUPERIORITY_OR_OTHER|||||||0.096|||||||ANCOVA|p-value for comparison between active and placebo at Week 156 based on ANCOVA model, adjusted for BL EDSS (\<=5.5 or\>=6) and BL T25FW.||Overall: Week 156||||0.0960
72621464|NCT02732145|144773198|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of the Anterior Commissure versus Posterior Commissure in patients with impaired vulvar skin and positive AWR?||||||0|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Anterior Commissure versus Posterior Commissure in patients with impaired vulvar skin and positive AWR.||||0.0000
72621465|NCT02732145|144773198|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of the Interlabial Sulci versus Labia Minora in patients with impaired vulvar skin and positive AWR?||||||0.4505|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Interlabial Sulci versus Labia Minora in patients with impaired vulvar skin and positive AWR.||||0.4505
72465930|NCT00943722|144454761|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the ratio of the GMTs be entirely contained within the interval (0.5, 2.0)|GMT ratio|1.12|||||TWO_SIDED|95.0|1.0|1.26|||||GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 2) divided by GMT for 9- to 15-Year-Old Females (Lot 3)|Anti-HPV 58||1.26|1.00|
72465931|NCT00943722|144454765|NON_INFERIORITY|Noninferiority is demonstrated if the lower limit of the 95% CI for the percentage point difference is greater than -5.|Percentage Point Difference|0.1|||<|0.001|TWO_SIDED|95.0|-0.8|1.5|||Miettinen and Nurminen||Percentage Point Difference = 9- to 15-Year-Old Females (Lot 1) minus 16- to 26-Year-Old Females (Lot 1)|Anti-HPV 6||1.5|-0.8|< 0.001
72465932|NCT00943722|144454765|NON_INFERIORITY|Noninferiority is demonstrated if the lower limit of the 95% CI for the percentage point difference is greater than -5.|Percentage Point Difference|0.0|||<|0.001|TWO_SIDED|95.0|-0.7|1.2|||Miettinen and Nurminen||Percentage Point Difference = 9- to 15-Year-Old Females (Lot 1) minus 16- to 26-Year-Old Females (Lot 1)|Anti-HPV 11||1.2|-0.7|< 0.001
72503035|NCT01416181|144536442|SUPERIORITY_OR_OTHER|||||||0.4957|||||||ANCOVA|p-value for comparison between active and placebo at Week 156 based on ANCOVA model, adjusted for BL EDSS (\<=5.5 or\>=6) and BL T25FW.||CP Group: Week 156||||0.4957
72503036|NCT01416181|144536442|SUPERIORITY_OR_OTHER|||||||0.2916|||||||ANCOVA|p-value for comparison between active and placebo at Week 156 based on ANCOVA model, adjusted for BL EDSS (\<=5.5 or\>=6) and BL T25FW.||NP Group: Week 156||||0.2916
72503037|NCT01416181|144536443|SUPERIORITY_OR_OTHER|||||||0.1119|||||||ANCOVA|p-value for comparison between active \& placebo groups at Week 156 based on ANCOVA model, adjusted for BL EDSS (≤5.5 or ≥6) \& BL 9HPT (dominant hand).||Overall, Week 156||||0.1119
72503038|NCT01416181|144536443|SUPERIORITY_OR_OTHER|||||||0.1129|||||||ANCOVA|p-value for comparison between active \& placebo groups at Week 156 based on ANCOVA model, adjusted for BL EDSS (≤5.5 or ≥6) \& BL 9HPT (dominant hand).||CP Group: Week 156||||0.1129
72503039|NCT01416181|144536443|SUPERIORITY_OR_OTHER|||||||0.2351|||||||ANCOVA|p-value for comparison between active \& placebo groups at Week 156 based on ANCOVA model, adjusted for BL EDSS (≤5.5 or ≥6) \& BL 9HPT (dominant hand).||NP Group: Week 156||||0.2351
72503040|NCT01416181|144536444|SUPERIORITY_OR_OTHER|||||||0.0261|||||||ANCOVA|p-value for comparison between active \& placebo groups at Week 156 based on ANCOVA model, adjusted for BL EDSS (≤5.5 or ≥6) \& BL 9HPT (dominant hand).||Overall: Week 156||||0.0261
72503041|NCT01416181|144536444|SUPERIORITY_OR_OTHER|||||||0.0585|||||||ANCOVA|p-value for comparison between active \& placebo groups at Week 156 based on ANCOVA model, adjusted for BL EDSS (≤5.5 or ≥6) \& BL 9HPT (dominant hand).||CP Group: Week 156||||0.0585
72503042|NCT01416181|144536444|SUPERIORITY_OR_OTHER|||||||0.6095|||||||ANCOVA|p-value for comparison between active \& placebo groups at Week 156 based on ANCOVA model, adjusted for BL EDSS (≤5.5 or ≥6) \& BL 9HPT (dominant hand).||NP Group: Week 156||||0.6095
72503043|NCT01416181|144536445|SUPERIORITY_OR_OTHER|||||||0.723|||||||ANCOVA|p-value for comparison between active \& placebo groups at Week 156 based on ANCOVA, adjusted for BL EDSS (≤5.5 or ≥6) \& BL 9HPT (non-dominant hand).||Overall: Week 156||||0.7230
72394366|NCT01782222|144295593|SUPERIORITY_OR_OTHER||Least Square Mean|0.02|STANDARD_ERROR_OF_MEAN|0.38||0.968|TWO_SIDED|95.0|-0.74|0.77|||ANCOVA|ANCOVA model for the change from Baseline to End of Maintenance containing treatment and disease stage as factors, and Baseline value as covariate.||||0.77|-0.74|0.968
72465933|NCT00943722|144454765|NON_INFERIORITY|Noninferiority is demonstrated if the lower limit of the 95% CI for the percentage point difference is greater than -5.|Percentage Point Difference|0.0|||<|0.001|TWO_SIDED|95.0|-0.7|1.2|||Miettinen and Nurminen||Percentage Point Difference = 9- to 15-Year-Old Females (Lot 1) minus 16- to 26-Year-Old Females (Lot 1)|Anti-HPV 16||1.2|-0.7|< 0.001
72465934|NCT00943722|144454765|NON_INFERIORITY|Noninferiority is demonstrated if the lower limit of the 95% CI for the percentage point difference is greater than -5.|Percentage Point Difference|0.1|||<|0.001|TWO_SIDED|95.0|-0.8|1.5|||Miettinen and Nurminen||Percentage Point Difference = 9- to 15-Year-Old Females (Lot 1) minus 16- to 26-Year-Old Females (Lot 1)|Anti-HPV 18||1.5|-0.8|< 0.001
72503044|NCT01416181|144536445|SUPERIORITY_OR_OTHER|||||||0.8781|||||||ANCOVA|p-value for comparison between active \& placebo groups at Week 156 based on ANCOVA, adjusted for BL EDSS (≤5.5 or ≥6) \& BL 9HPT (non-dominant hand).||CP Group: Week 156||||0.8781
72503045|NCT01416181|144536445|SUPERIORITY_OR_OTHER|||||||0.2751|||||||ANCOVA|p-value for comparison between active \& placebo groups at Week 156 based on ANCOVA, adjusted for BL EDSS (≤5.5 or ≥6) \& BL 9HPT (non-dominant hand).||NP Group: Week 156||||0.2751
72503046|NCT01416181|144536446|SUPERIORITY_OR_OTHER|||||||0.5051|||||||ANCOVA|p-value for comparison between active \& placebo groups at Week 156 based on ANCOVA, adjusted for BL EDSS (≤5.5 or ≥6) \& BL 9HPT (non-dominant hand).||Overall: Week 156||||0.5051
72503047|NCT01416181|144536446|SUPERIORITY_OR_OTHER|||||||0.7283|||||||ANCOVA|p-value for comparison between active \& placebo groups at Week 156 based on ANCOVA, adjusted for BL EDSS (≤5.5 or ≥6) \& BL 9HPT (non-dominant hand).||CP Group: Week 156||||0.7283
72503048|NCT01416181|144536446|SUPERIORITY_OR_OTHER|||||||0.1666|||||||ANCOVA|p-value for comparison between active \& placebo groups at Week 156 based on ANCOVA, adjusted for BL EDSS (≤5.5 or ≥6) \& BL 9HPT (non-dominant hand).||NP Group: Week 156||||0.1666
72503049|NCT01416181|144536447|SUPERIORITY_OR_OTHER|||||||0.433|||||||ANCOVA|p-value for comparison between active \& placebo groups at Week 156 based on ANCOVA, adjusted for BL EDSS (≤5.5 or ≥6).||Overall: Week 156||||0.4330
72503050|NCT01416181|144536447|SUPERIORITY_OR_OTHER|||||||0.7122|||||||ANCOVA|p-value for comparison between active \& placebo groups at Week 156 based on ANCOVA, adjusted for BL EDSS (≤5.5 or ≥6).||CP Group: Week 156||||0.7122
72503051|NCT01416181|144536447|SUPERIORITY_OR_OTHER|||||||0.3861|||||||ANCOVA|p-value for comparison between active \& placebo groups at Week 156 based on ANCOVA, adjusted for BL EDSS (≤5.5 or ≥6).||NP Group: Week 156||||0.3861
72465935|NCT00943722|144454765|NON_INFERIORITY|Noninferiority is demonstrated if the lower limit of the 95% CI for the percentage point difference is greater than -5.|Percentage Point Difference|0.3|||<|0.001|TWO_SIDED|95.0|-0.4|1.7|||Miettinen and Nurminen||Percentage Point Difference = 9- to 15-Year-Old Females (Lot 1) minus 16- to 26-Year-Old Females (Lot 1)|Anti-HPV 31||1.7|-0.4|< 0.001
72503052|NCT01416181|144536448|SUPERIORITY_OR_OTHER|||||||0.7225|||||||ANCOVA|p-value for comparison between active \& placebo groups at Week 156 based on ANCOVA, adjusted for BL EDSS (≤5.5 or ≥6).||Overall: Week 156||||0.7225
72503053|NCT01416181|144536448|SUPERIORITY_OR_OTHER|||||||0.9121|||||||ANCOVA|p-value for comparison between active \& placebo groups at Week 156 based on ANCOVA, adjusted for BL EDSS (≤5.5 or ≥6).||CP Group: Week 156||||0.9121
72503054|NCT01416181|144536448|SUPERIORITY_OR_OTHER|||||||0.2594|||||||ANCOVA|p-value for comparison between active \& placebo groups at Week 156 based on ANCOVA, adjusted for BL EDSS (≤5.5 or ≥6).||NP Group: Week 156||||0.2594
72503055|NCT01416181|144536449|SUPERIORITY_OR_OTHER|||||||0.8066|||||||ANCOVA|p-value for comparison between active \& placebo groups at Week 156 based on ANCOVA model, adjusted for BL EDSS (≤5.5 or ≥6) \& BL 6MWT.||Week 156||||0.8066
72503056|NCT01416181|144536451|SUPERIORITY_OR_OTHER|||||||0.7084|||||||ANCOVA|p-value for comparison between active \& placebo at Week 156 based on ANCOVA model, adjusted for BL EDSS (≤5.5 or ≥6) \& BL MSIS-29 physical score.||||||0.7084
72503057|NCT01416181|144536453|SUPERIORITY_OR_OTHER|||||||0.3465|||||||ANCOVA|p-value for comparison between active and placebo at Week 156 based on ANCOVA model, adjusted for BL EDSS (\<=5.5 or\>=6) and BL SDMT.||Week 156||||0.3465
72503058|NCT01416181|144536457|SUPERIORITY_OR_OTHER|||||||0.007||||||natalizumab participants had a baseline after 6 months of treatment and the placebo-to-natalizumab group had a baseline of initiation of treatment|ANCOVA|p-value for comparison between active \& placebo at Week 156 based on ANCOVA model, adjusted for BL EDSS (≤5.5 or ≥6) \& BL normalized brain volume.||Percentage change from Week 24 to Week 156||||0.0070
72503059|NCT01416181|144536458|SUPERIORITY_OR_OTHER|||||||0.5034||||||natalizumab participants had a baseline after 6 months of treatment and the placebo-to-natalizumab group had a baseline of initiation of treatment|ANCOVA|p-value for comparison between active \& placebo at Week 156 based on ANCOVA model, adjusted for BL EDSS (≤5.5 or ≥6) \& BL WGM brain volume||Percentage hange from Baseline to Week 156||||0.5034
72503060|NCT01416181|144536459|SUPERIORITY_OR_OTHER||||||<|0.0001||||||p-value for comparison between the active and placebo groups at Week 156 compared to Week 108 is based on negative binomial regression model, adjusted for baseline EDSS (\<=5.5 or \>=6) and baseline volume of T2 lesions.|negative binomial regression model|natalizumab participants had a baseline after 6 months of treatment and the placebo-to-natalizumab group had a baseline of initiation of treatment||Week 156||||< 0.0001
72564329|NCT00483548|144660355|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|0.09|STANDARD_ERROR_OF_MEAN|0.14||0.536||95.0|-0.19|0.36|||ANCOVA|||Overall life satisfaction: Week 6; Observed cases; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.||0.36|-0.19|0.5360
72564330|NCT00868296|144660395|SUPERIORITY_OR_OTHER|||||||0.857||||||Analysis with treatment as factor; baseline as covariate|ANCOVA|||Between group comparison for change from baseline in length z-score.||||0.857
72621466|NCT02732145|144773198|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Interlabial Sulci versus Posterior Commissure in patients with impaired vulvar skin and positive AWR?||||||0|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Interlabial Sulci versus Posterior Commissure in patients with impaired vulvar skin and positive AWR.||||0.0000
72621467|NCT02732145|144773198|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of the Labia Minora versus Posterior Commissure in patients with impaired vulvar skin and positive AWR?||||||0|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Labia Minora versus Posterior Commissure in patients with impaired vulvar skin and positive AWR.||||0.0000
72621468|NCT02732145|144773198|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of the Anterior Commissure versus Interlabial Sulci in patients with normal vulva and positive AWR?||||||1|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Anterior Commissure versus Interlabial Sulci in patients with normal vulva and positive AWR.||||1.0000
72465936|NCT00943722|144454765|NON_INFERIORITY|Noninferiority is demonstrated if the lower limit of the 95% CI for the percentage point difference is greater than -5.|Percentage Point Difference|0.3|||<|0.001|TWO_SIDED|95.0|-0.4|1.6|||Miettinen and Nurminen||Percentage Point Difference = 9- to 15-Year-Old Females (Lot 1) minus 16- to 26-Year-Old Females (Lot 1)|Anti-HPV 33||1.6|-0.4|< 0.001
72564331|NCT00868296|144660395|SUPERIORITY_OR_OTHER|||||||0.901||||||Analysis with treatment as factor; baseline as covariate|ANCOVA|||Between group comparison for change from baseline in weight z-score.||||0.901
72564332|NCT00868296|144660395|SUPERIORITY_OR_OTHER|||||||0.807||||||Analysis with treatment as factor; baseline as covariate|ANCOVA|||Between group comparison for change from baseline in head circumference z-score.||||0.807
72564333|NCT00868296|144660395|SUPERIORITY_OR_OTHER|||||||0.595|||||||t-test, 2 sided|paired||Final evaluation compared to baseline within group comparison for length z-score.||||0.595
72564334|NCT00868296|144660395|SUPERIORITY_OR_OTHER|||||||0.016|||||||t-test, 2 sided|paired||Final evaluation compared to baseline within group comparison for length z-score.||||0.016
72564335|NCT00868296|144660395|SUPERIORITY_OR_OTHER|||||||0.347|||||||t-test, 2 sided|paired||Final evaluation compared to baseline within group comparison for weight z-score.||||0.347
72564336|NCT00868296|144660395|SUPERIORITY_OR_OTHER|||||||0.04|||||||t-test, 2 sided|paired||Final evaluation compared to baseline within group comparison for weight z-score.||||0.040
72564337|NCT00868296|144660395|SUPERIORITY_OR_OTHER|||||||0.892|||||||t-test, 2 sided|paired||Final evaluation compared to baseline within group comparison for head circumference z-score.||||0.892
72564338|NCT00868296|144660395|SUPERIORITY_OR_OTHER|||||||0.006|||||||t-test, 2 sided|paired||Final evaluation compared to baseline within group comparison for head circumference z-score.||||0.006
72564339|NCT02075606|144660409|OTHER||Odds Ratio (OR)|0.17|||=|0.126|TWO_SIDED|95.0|0.02|1.65|||Regression, Logistic|||Clinical symptomatic response as dependent variable and CTC presence at baseline as explanatory variable was used to perform the logistic regression analysis.||1.65|0.02|=0.126
72465937|NCT00943722|144454765|NON_INFERIORITY|Noninferiority is demonstrated if the lower limit of the 95% CI for the percentage point difference is greater than -5.|Percentage Point Difference|0.4|||<|0.001|TWO_SIDED|95.0|-0.6|1.8|||Miettinen and Nurminen||Percentage Point Difference = 9- to 15-Year-Old Females (Lot 1) minus 16- to 26-Year-Old Females (Lot 1)|Anti-HPV 45||1.8|-0.6|< 0.001
72465938|NCT00943722|144454765|NON_INFERIORITY|Noninferiority is demonstrated if the lower limit of the 95% CI for the percentage point difference is greater than -5.|Percentage Point Difference|0.3|||<|0.001|TWO_SIDED|95.0|-0.4|1.7|||Miettinen and Nurminen||Percentage Point Difference = 9- to 15-Year-Old Females (Lot 1) minus 16- to 26-Year-Old Females (Lot 1)|Anti-HPV 52||1.7|-0.4|< 0.001
72465939|NCT00943722|144454765|NON_INFERIORITY|Noninferiority is demonstrated if the lower limit of the 95% CI for the percentage point difference is greater than -5.|Percentage Point Difference|0.0|||<|0.001|TWO_SIDED|95.0|-0.7|1.2|||Miettinen and Nurminen||Percentage Point Difference = 9- to 15-Year-Old Females (Lot 1) minus 16- to 26-Year-Old Females (Lot 1)|Anti-HPV 58||1.2|-0.7|< 0.001
72465940|NCT00943722|144454766|NON_INFERIORITY|Noninferiority is demonstrated if the lower limit of the 95% CI for the percentage point difference is greater than -5.|Percentage Point Difference|0.1|||<|0.001|TWO_SIDED|95.0|-0.7|1.5|||Miettinen and Nurminen||Percentage Point Difference = 9- to 15-Year-Old Males (Lot 1) minus 16- to 26-Year-Old Females (Lot 1)|Anti-HPV 6||1.5|-0.7|< 0.001
72465941|NCT00943722|144454766|NON_INFERIORITY|Noninferiority is demonstrated if the lower limit of the 95% CI for the percentage point difference is greater than -5.|Percentage Point Difference|0.0|||<|0.001|TWO_SIDED|95.0|-0.7|1.2|||Miettinen and Nurminen||Percentage Point Difference = 9- to 15-Year-Old Males (Lot 1) minus 16- to 26-Year-Old Females (Lot 1)|Anti-HPV 11||1.2|-0.7|< 0.001
72465942|NCT00943722|144454766|NON_INFERIORITY|Noninferiority is demonstrated if the lower limit of the 95% CI for the percentage point difference is greater than -5.|Percentage Point Difference|0.0|||<|0.001|TWO_SIDED|95.0|-0.7|1.2|||Miettinen and Nurminen||Percentage Point Difference = 9- to 15-Year-Old Males (Lot 1) minus 16- to 26-Year-Old Females (Lot 1)|Anti-HPV 16||1.2|-0.7|< 0.001
72465943|NCT00943722|144454766|NON_INFERIORITY|Noninferiority is demonstrated if the lower limit of the 95% CI for the percentage point difference is greater than -5.|Percentage Point Difference|0.3|||<|0.001|TWO_SIDED|95.0|-0.4|1.6|||Miettinen and Nurminen||Percentage Point Difference = 9- to 15-Year-Old Males (Lot 1) minus 16- to 26-Year-Old Females (Lot 1)|Anti-HPV 18||1.6|-0.4|< 0.001
72465944|NCT00943722|144454766|NON_INFERIORITY|Noninferiority is demonstrated if the lower limit of the 95% CI for the percentage point difference is greater than -5.|Percentage Point Difference|0.3|||<|0.001|TWO_SIDED|95.0|-0.4|1.7|||Miettinen and Nurminen||Percentage Point Difference = 9- to 15-Year-Old Males (Lot 1) minus 16- to 26-Year-Old Females (Lot 1)|Anti-HPV 31||1.7|-0.4|< 0.001
72465945|NCT00943722|144454766|NON_INFERIORITY|Noninferiority is demonstrated if the lower limit of the 95% CI for the percentage point difference is greater than -5.|Percentage Point Difference|0.3|||<|0.001|TWO_SIDED|95.0|-0.4|1.6|||Miettinen and Nurminen||Percentage Point Difference = 9- to 15-Year-Old Males (Lot 1) minus 16- to 26-Year-Old Females (Lot 1)|Anti-HPV 33||1.6|-0.4|< 0.001
72465946|NCT00943722|144454766|NON_INFERIORITY|Noninferiority is demonstrated if the lower limit of the 95% CI for the percentage point difference is greater than -5.|Percentage Point Difference|0.5|||<|0.001|TWO_SIDED|95.0|-0.1|2.0|||Miettinen and Nurminen||Percentage Point Difference = 9- to 15-Year-Old Males (Lot 1) minus 16- to 26-Year-Old Females (Lot 1)|Anti-HPV 45||2.0|-0.1|< 0.001
72465947|NCT00943722|144454766|NON_INFERIORITY|Noninferiority is demonstrated if the lower limit of the 95% CI for the percentage point difference is greater than -5.|Percentage Point Difference|0.3|||<|0.001|TWO_SIDED|95.0|-0.4|1.7|||Miettinen and Nurminen||Percentage Point Difference = 9- to 15-Year-Old Males (Lot 1) minus 16- to 26-Year-Old Females (Lot 1)|Anti-HPV 52||1.7|-0.4|< 0.001
72465948|NCT00943722|144454766|NON_INFERIORITY|Noninferiority is demonstrated if the lower limit of the 95% CI for the percentage point difference is greater than -5.|Percentage Point Difference|0.0|||<|0.001|TWO_SIDED|95.0|-0.7|1.2|||Miettinen and Nurminen||Percentage Point Difference = 9- to 15-Year-Old Males (Lot 1) minus 16- to 26-Year-Old Females (Lot 1)|Anti-HPV 58||1.2|-0.7|< 0.001
72465949|NCT00943722|144454767|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the difference in percentages between lots be entirely contained within the interval (-5, 5).|Percentage Point Difference|0.0|||||TWO_SIDED|95.0|-0.9|0.9|||||Percentage Point Difference = 9- to 15-Year-Old Females (Lot 1) minus 9- to 15-Year-Old Females (Lot 2)|Anti-HPV 6||0.9|-0.9|
72465950|NCT00943722|144454767|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the difference in percentages between lots be entirely contained within the interval (-5, 5).|Percentage Point Difference|0.5|||||TWO_SIDED|95.0|-0.4|1.7|||||Percentage Point Difference = 9- to 15-Year-Old Females (Lot 1) minus 9- to 15-Year-Old Females (Lot 3)|Anti-HPV 6||1.7|-0.4|
72465951|NCT00943722|144454767|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the difference in percentages between lots be entirely contained within the interval (-5, 5).|Percentage Point Difference|0.6|||||TWO_SIDED|95.0|-0.4|1.7|||||Percentage Point Difference = 9- to 15-Year-Old Females (Lot 2) minus 9- to 15-Year-Old Females (Lot 3)|Anti-HPV 6||1.7|-0.4|
72465952|NCT00943722|144454767|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the difference in percentages between lots be entirely contained within the interval (-5, 5).|Percentage Point Difference|0.0|||||TWO_SIDED|95.0|-0.7|0.7|||||Percentage Point Difference = 9- to 15-Year-Old Females (Lot 1) minus 9- to 15-Year-Old Females (Lot 2)|Anti-HPV 11||0.7|-0.7|
72465953|NCT00943722|144454767|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the difference in percentages between lots be entirely contained within the interval (-5, 5).|Percentage Point Difference|0.4|||||TWO_SIDED|95.0|-0.4|1.3|||||Percentage Point Difference = 9- to 15-Year-Old Females (Lot 1) minus 9- to 15-Year-Old Females (Lot 3)|Anti-HPV 11||1.3|-0.4|
72465954|NCT00943722|144454767|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the difference in percentages between lots be entirely contained within the interval (-5, 5).|Percentage Point Difference|0.4|||||TWO_SIDED|95.0|-0.4|1.3|||||Percentage Point Difference = 9- to 15-Year-Old Females (Lot 2) minus 9- to 15-Year-Old Females (Lot 3)|Anti-HPV 11||1.3|-0.4|
72465955|NCT00943722|144454767|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the difference in percentages between lots be entirely contained within the interval (-5, 5).|Percentage Point Difference|0.0|||||TWO_SIDED|95.0|-0.7|0.7|||||Percentage Point Difference = 9- to 15-Year-Old Females (Lot 1) minus 9- to 15-Year-Old Females (Lot 2)|Anti-HPV 16||0.7|-0.7|
72465956|NCT00943722|144454767|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the difference in percentages between lots be entirely contained within the interval (-5, 5).|Percentage Point Difference|0.4|||||TWO_SIDED|95.0|-0.4|1.3|||||Percentage Point Difference = 9- to 15-Year-Old Females (Lot 1) minus 9- to 15-Year-Old Females (Lot 3)|Anti-HPV 16||1.3|-0.4|
72503061|NCT00698516|144536464|SUPERIORITY_OR_OTHER||Greenwood variance|65.0|STANDARD_ERROR_OF_MEAN|7.07||0.017|TWO_SIDED|95.0|49.3|76.9||Historical data in target population showed 3-month PFS rates of \<=50%. Oral topotecan with IV bevacizumab would provide clinically meaningful improvement in 3-month PFS if it could demonstrate a 40% improvement relative to the historical data.|Z statistic|Z statistic was used to reject the null hypothesis provided Z\>=1.65, where Z = (KM estimate at 3 months - null hypothesis value \[50%\])/Greenwood SE.||||76.9|49.3|0.017
72503062|NCT01142323|144536522|SUPERIORITY_OR_OTHER|||||||0.008|TWO_SIDED|95.0|||||Matched pairs|||||||0.008
72503063|NCT01142323|144536523|SUPERIORITY|||||||0.46|||||||Wilcoxon (Mann-Whitney)|||||||0.46
72503064|NCT02158533|144536527|SUPERIORITY||Least squares mean difference|-1.8|STANDARD_ERROR_OF_MEAN|1.14||0.109|TWO_SIDED|95.0|-4.1|0.4||Hypothesis tests were two-sided with an alpha of 0.05. Control of type 1 error inflation due to multiplicity was achieved by pre-specifying a fixed sequence for statistical tests.|Mixed Models Analysis|ALKS 5461 was compared to pbo using stage-specific MMRM for MADRS-10 Change from Baseline. Model-derived estimates were combined using equal weights.|Estimates below zero favor ALKS 5461.|Analysis was conducted for each stage separately and overall efficacy was based on combined stage analysis where stage-specific estimates were combined using pre-specified equal weights. Within each stage ALKS 5461 2mg/2mg was compared to placebo (i.e., ALKS 5461 2mg/2mg S1 vs Placebo S1; and ALKS 5461 2mg/2mg S2 vs Placebo S2. The pre-specified order of hypothesis tests was ALKS 5461 2/2 compared to placebo followed by ALKS 5461 0.5mg/0.5mg compared to placebo.||0.4|-4.1|0.109
72503065|NCT02158533|144536527|SUPERIORITY||Least squares mean difference|0.0|STANDARD_ERROR_OF_MEAN|1.17||0.975|TWO_SIDED|95.0|-2.3|2.3||Hypothesis tests were two-sided with an alpha of 0.05. Control of type 1 error inflation due to multiplicity was achieved by pre-specifying a fixed sequence for statistical tests.|Mixed Models Analysis|ALKS 5461 was compared to pbo using stage-specific MMRM for MADRS-10 Change from Baseline. Model-derived estimates were combined using equal weights.|Estimates below zero favor ALKS 5461.|Analysis was conducted for each stage separately and overall efficacy was based on combined stage analysis where stage-specific estimates were combined using pre-specified equal weights. Within each stage ALKS 5461 0.5mg/0.5mg was compared to placebo (i.e., ALKS 5461 0.5mg/0.5mg S1 vs Placebo S1; and ALKS 5461 0.5mg/0.5mg S2 vs Placebo S2). The pre-specified order of hypothesis tests was ALKS 5461 2/2 compared to placebo followed by ALKS 5461 0.5/0.5 compared to placebo.||2.3|-2.3|0.975
72503066|NCT00917384|144536542|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.776||||0.0473||95.0|0.603|0.998|||Stratified Log-Rank Test|Stratified Log-Rank Test and HR stratified by randomization strata (weight loss over the prior 3 months, primary tumor site and geographical region).||||0.998|0.603|0.0473
72503067|NCT00917384|144536543|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.483|||<|0.0001|TWO_SIDED|95.0|0.376|0.62|||Stratified Log-Rank Test|Stratified Log-Rank Test and HR stratified by randomization strata (weight loss over the prior 3 months, primary tumor site and geographical region).||||0.620|0.376|<0.0001
72503068|NCT00917384|144536544|SUPERIORITY_OR_OTHER_LEGACY||Difference Between Arms|24.2|||<|0.0001|TWO_SIDED|95.0|14.9|33.6|||Normal Approximation|||||33.6|14.9|<0.0001
72503069|NCT00149214|144536553|SUPERIORITY_OR_OTHER||Percentage of Participants|16.5||||||95.0|10.5|24.2||||||Confidence Interval for pathological complete response in the Pemetrexed treatment arm.||24.2|10.5|
72621469|NCT02732145|144773198|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of the Anterior Commissure versus Labia Minora in patients with normal vulva and positive AWR?||||||0.0534|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Anterior Commissure versus Labia Minora in patients with normal vulva and positive AWR.||||0.0534
72621470|NCT02732145|144773198|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of the Anterior Commissure versus Posterior Commissure in patients with normal vulva and positive AWR?||||||0|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Anterior Commissure versus Posterior Commissure in patients with normal vulva and positive AWR.||||0.0000
72465957|NCT00943722|144454767|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the difference in percentages between lots be entirely contained within the interval (-5, 5).|Percentage Point Difference|0.4|||||TWO_SIDED|95.0|-0.4|1.3|||||Percentage Point Difference = 9- to 15-Year-Old Females (Lot 2) minus 9- to 15-Year-Old Females (Lot 3)|Anti-HPV 16||1.3|-0.4|
72503070|NCT00149214|144536553|SUPERIORITY_OR_OTHER||Percentage of Participants|20.2||||||95.0|13.4|28.5||||||Confidence Interval for pathological complete response in the Cyclophosphamide treatment group.||28.5|13.4|
72503071|NCT03230097|144536615|OTHER||Hazard Ratio (HR)|0.849||||0.7873|TWO_SIDED|95.0|0.258|2.795|||Regression, Cox|Stratified (by baseline use of antipsychotic medication) Cox proportional hazards model was used. Treatment effect and NAPLS risk score as covariates.|Ratio = BI 409306/placebo.|||2.795|0.258|0.7873
72503072|NCT03230097|144536617|OTHER||Adjusted mean difference|1.77||||0.5212|TWO_SIDED|95.0|-3.773|7.315|||Mixed Models Analysis|||BI 409306 vs. placebo of change from baseline at week 24. Restricted maximum likelihood (REML) mixed effects model with repeated measurements (MMRM) including fixed, categorical effects of treatment, visit, treatment by visit interaction, baseline North American Prodromal Longitudinal Study (NAPLS) risk score, baseline use of antipsychotic medication and continuous fixed covariates of baseline score and baseline-by-visit interaction.||7.315|-3.773|0.5212
72503073|NCT03230097|144536617|OTHER||Adjusted mean difference|3.18||||0.3127|TWO_SIDED|95.0|-3.071|9.425|||Mixed Models Analysis||Restricted maximum likelihood (REML) mixed effects model with repeated measurements (MMRM), see endpoint description for details.|BI 409306 vs. placebo of change from baseline at week 52. Restricted maximum likelihood (REML) mixed effects model with repeated measurements (MMRM) including fixed, categorical effects of treatment, visit, treatment by visit interaction, baseline North American Prodromal Longitudinal Study (NAPLS) risk score, baseline use of antipsychotic medication and continuous fixed covariates of baseline score and baseline-by-visit interaction.||9.425|-3.071|0.3127
72394367|NCT01782222|144295594|SUPERIORITY_OR_OTHER||Least Square Mean|0.16|STANDARD_ERROR_OF_MEAN|1.26||0.899|TWO_SIDED|95.0|-2.34|2.66|||ANCOVA|ANCOVA model for the change from Baseline to End of Maintenance containing treatment and disease stage as factors, and Baseline value as covariate.||||2.66|-2.34|0.899
72394368|NCT01782222|144295594|SUPERIORITY_OR_OTHER||Least Square Mean|-0.33|STANDARD_ERROR_OF_MEAN|1.19||0.785|TWO_SIDED|95.0|-2.68|2.03|||ANCOVA|ANCOVA model for the change from Baseline to End of Treatment containing treatment and disease stage as factors, and Baseline value as covariate.||||2.03|-2.68|0.785
72394369|NCT01782222|144295595|SUPERIORITY_OR_OTHER||Least Square Mean|-4.96|STANDARD_ERROR_OF_MEAN|1.99||0.014|TWO_SIDED|95.0|-8.91|-1.01|||ANCOVA|ANCOVA model for the change from Baseline to End of Maintenance containing treatment and disease stage as factors, and Baseline value as covariate.||||-1.01|-8.91|0.014
72394370|NCT01782222|144295595|SUPERIORITY_OR_OTHER||Least Square Mean|-4.83|STANDARD_ERROR_OF_MEAN|1.92||0.013|TWO_SIDED|95.0|-8.63|-1.03|||ANCOVA|ANCOVA model for the change from Baseline to End of Maintenance containing treatment and disease stage as factors, and Baseline value as covariate.||||-1.03|-8.63|0.013
72394371|NCT01897402|144295676|NON_INFERIORITY_OR_EQUIVALENCE|The assumptions for the sample size calculations were: 1) Seroconversion for the control vaccine (Menactra) is 40-80% and 2) the true treatments are theoretically equal and 3) the power of detecting non-inferiority is 90%.|Percentage Difference|0.6|||||TWO_SIDED|95.0|-7.9|9.1|||||Serogroup A|The hypothesis was that the test vaccine is comparable to the licensed active control vaccine. Differences between treatment groups were described using exact two-sided 95% confidence intervals on differences in % seroconversion between the two treatment groups (test vaccine minus reference vaccine) for each serogroup. If the lower bound of the difference is ≥ -15%, then the test vaccine meets the preliminary criterion for non-inferiority.||9.1|-7.9|
72394372|NCT01897402|144295676|NON_INFERIORITY_OR_EQUIVALENCE|The assumptions for the sample size calculations were: 1) Seroconversion for the control vaccine (Menactra) is 40-80% and 2) the true treatments are theoretically equal and 3) the power of detecting non-inferiority is 90%.|Percentage Difference|-6.0|||||TWO_SIDED|95.0|-14.6|2.6|||||Serogroup C|The hypothesis was that the test vaccine is comparable to the licensed active control vaccine. Differences between treatment groups were described using exact two-sided 95% confidence intervals on differences in % seroconversion between the two treatment groups (test vaccine minus reference vaccine) for each serogroup. If the lower bound of the difference is ≥ -15%, then the test vaccine meets the preliminary criterion for non-inferiority.||2.6|-14.6|
72394373|NCT01897402|144295676|NON_INFERIORITY_OR_EQUIVALENCE|The assumptions for the sample size calculations were: 1) Seroconversion for the control vaccine (Menactra) is 40-80% and 2) the true treatments are theoretically equal and 3) the power of detecting non-inferiority is 90%.|Percentage Difference|-1.0|||||TWO_SIDED|95.0|-9.9|7.9|||||Serogroup Y|The hypothesis was that the test vaccine is comparable to the licensed active control vaccine. Differences between treatment groups were described using exact two-sided 95% confidence intervals on differences in % seroconversion between the two treatment groups (test vaccine minus reference vaccine) for each serogroup. If the lower bound of the difference is ≥ -15%, then the test vaccine meets the preliminary criterion for non-inferiority.||7.9|-9.9|
72465958|NCT00943722|144454767|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the difference in percentages between lots be entirely contained within the interval (-5, 5).|Percentage Point Difference|-0.2|||||TWO_SIDED|95.0|-1.1|0.5|||||Percentage Point Difference = 9- to 15-Year-Old Females (Lot 1) minus 9- to 15-Year-Old Females (Lot 2)|Anti-HPV 18||0.5|-1.1|
72465959|NCT00943722|144454767|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the difference in percentages between lots be entirely contained within the interval (-5, 5).|Percentage Point Difference|0.2|||||TWO_SIDED|95.0|-0.7|1.1|||||Percentage Point Difference = 9- to 15-Year-Old Females (Lot 1) minus 9- to 15-Year-Old Females (Lot 3)|Anti-HPV 18||1.1|-0.7|
72503074|NCT03230097|144536618|OTHER||Adjusted mean difference|-4.99||||0.1602|TWO_SIDED|95.0|-12.033|2.057|||Mixed Models Analysis|||BI 409306 vs. placebo of change from baseline at week 52. Restricted maximum likelihood (REML) mixed effects model with repeated measurements (MMRM) including fixed, categorical effects of treatment, visit, treatment by visit interaction, baseline North American Prodromal Longitudinal Study (NAPLS) risk score, baseline use of antipsychotic medication and continuous fixed covariates of baseline score and baseline-by-visit interaction.||2.057|-12.033|0.1602
72394374|NCT01897402|144295676|NON_INFERIORITY_OR_EQUIVALENCE|The assumptions for the sample size calculations were: 1) Seroconversion for the control vaccine (Menactra) is 40-80% and 2) the true treatments are theoretically equal and 3) the power of detecting non-inferiority is 90%.|Percentage Difference|0.3|||||TWO_SIDED|95.0|-8.5|9.1|||||Serogroup W-135|The hypothesis was that the test vaccine is comparable to the licensed active control vaccine. Differences between treatment groups were described using exact two-sided 95% confidence intervals on differences in % seroconversion between the two treatment groups (test vaccine minus reference vaccine) for each serogroup. If the lower bound of the difference is ≥ -15%, then the test vaccine meets the preliminary criterion for non-inferiority.||9.1|-8.5|
72394375|NCT01209260|144295685|SUPERIORITY_OR_OTHER|||||||0.005||||||Statistical tests were 2-sided and considered significant if they yielded a p\<0.05|t-test, 2 sided|||Sample size of 72 was targeted to achieve 80% power to detect a 5-minute reduction in transseptal access procedure time (assuming a standard deviation of 7.5 minutes), using a 2-sided alpha of 0.05, with the primary analysis done on an intention-to-treat basis.||||0.005
72394376|NCT01209260|144295687|SUPERIORITY_OR_OTHER||||||<|0.001||||||Statistical tests were 2-sided and considered significant if they yielded a p\<0.05|Chi-squared|||||||<0.001
72394377|NCT01209260|144295688|SUPERIORITY_OR_OTHER||||||<|0.001||||||Statistical tests were 2-sided and considered significant if they yielded a p\<0.05.|Chi-squared|||||||<0.001
72465960|NCT00943722|144454767|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the difference in percentages between lots be entirely contained within the interval (-5, 5).|Percentage Point Difference|0.4|||||TWO_SIDED|95.0|-0.4|1.3|||||Percentage Point Difference = 9- to 15-Year-Old Females (Lot 2) minus 9- to 15-Year-Old Females (Lot 3)|Anti-HPV 18||1.3|-0.4|
72465961|NCT00943722|144454767|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the difference in percentages between lots be entirely contained within the interval (-5, 5).|Percentage Point Difference|0.0|||||TWO_SIDED|95.0|-0.7|0.7|||||Percentage Point Difference = 9- to 15-Year-Old Females (Lot 1) minus 9- to 15-Year-Old Females (Lot 2)|Anti-HPV 31||0.7|-0.7|
72621471|NCT02732145|144773198|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of the Interlabial Sulci versus Labia Minora in patients with normal vulva and positive AWR?||||||0.0534|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Interlabial Sulci versus Labia Minora in patients with normal vulva and positive AWR.||||0.0534
72621472|NCT02732145|144773198|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of the Interlabial Sulci versus Posterior Commissure in patients with normal vulva and positive AWR?||||||0|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Interlabial Sulci versus Posterior Commissure in patients with normal vulva and positive AWR.||||0.0000
72621473|NCT02732145|144773198|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of the Labia Minora versus Posterior Commissure in patients with normal vulva and positive AWR?||||||0.0005|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Labia Minora versus Posterior Commissure in patients with normal vulva and positive AWR.||||0.0005
72465962|NCT00943722|144454767|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the difference in percentages between lots be entirely contained within the interval (-5, 5).|Percentage Point Difference|0.2|||||TWO_SIDED|95.0|-0.6|1.0|||||Percentage Point Difference = 9- to 15-Year-Old Females (Lot 1) minus 9- to 15-Year-Old Females (Lot 3)|Anti-HPV 31||1.0|-0.6|
72465963|NCT00943722|144454767|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the difference in percentages between lots be entirely contained within the interval (-5, 5).|Percentage Point Difference|0.2|||||TWO_SIDED|95.0|-0.5|1.0|||||Percentage Point Difference = 9- to 15-Year-Old Females (Lot 2) minus 9- to 15-Year-Old Females (Lot 3)|Anti-HPV 31||1.0|-0.5|
72503075|NCT03230097|144536619|OTHER||Adjusted mean difference|-0.8||||0.5858|TWO_SIDED|95.0|-3.749|2.153|||Mixed Models Analysis|||BI 409306 vs. placebo of change from baseline at week 52, positive items score. Restricted maximum likelihood (REML) mixed effects model with repeated measurements (MMRM) including fixed, categorical effects of treatment, visit, treatment by visit interaction, baseline North American Prodromal Longitudinal Study (NAPLS) risk score, baseline use of antipsychotic medication and continuous fixed covariates of baseline score and baseline-by-visit interaction.||2.153|-3.749|0.5858
72503076|NCT03230097|144536619|OTHER||Adjusted mean difference|1.43||||0.3445|TWO_SIDED|95.0|-1.604|4.462|||Mixed Models Analysis|||BI 409306 vs. placebo of change from baseline at week 52, negative items score. Restricted maximum likelihood (REML) mixed effects model with repeated measurements (MMRM) including fixed, categorical effects of treatment, visit, treatment by visit interaction, baseline North American Prodromal Longitudinal Study (NAPLS) risk score, baseline use of antipsychotic medication and continuous fixed covariates of baseline score and baseline-by-visit interaction.||4.462|-1.604|0.3445
72503077|NCT03230097|144536619|OTHER||Adjusted mean difference|1.71||||0.7154|TWO_SIDED|95.0|-7.772|11.196|||Mixed Models Analysis|||BI 409306 vs. placebo of change from baseline at week 52, total score. Restricted maximum likelihood (REML) mixed effects model with repeated measurements (MMRM) including fixed, categorical effects of treatment, visit, treatment by visit interaction, baseline North American Prodromal Longitudinal Study (NAPLS) risk score, baseline use of antipsychotic medication and continuous fixed covariates of baseline score and baseline-by-visit interaction.||11.196|-7.772|0.7154
72503078|NCT00749606|144536624|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||Mixed Models Analysis|Mixed linear models analyzed within-subject variation in repeated measures over time. Intention to treat analysis used 5 imputations for missing data.||||||<0.01
72503079|NCT01121406|144536631|SUPERIORITY_OR_OTHER||Difference in Kaplan-Meier DC rates|-12.5|||||TWO_SIDED|95.0|-31.1|6.0|||||"95% CI using Greenwood´s variance estimate.~Volasertib (BI 6727) minus Cytotoxic."|Kaplan Meier estimates and confidence intervals (CI) were calculated using Greenwood's variance estimate within each treatment arm and the asymptotic CI for the difference in the rates found. The time was censored in those cases where there was no death or progression until the last trial visit||6.0|-31.1|
72503080|NCT01121406|144536632|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.01|||||TWO_SIDED|95.0|0.66|1.53|||||"Cox proportional-hazards regression model, stratified by disease status at baseline (measurable vs. non measurable disease) and platinum resistant vs platinum refractory disease at baseline.~HR calculated as Volasertib (BI 6727) /Cytotoxic"|||1.53|0.66|
72503081|NCT01121406|144536633|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.94|||||TWO_SIDED|95.0|0.63|1.42|||||"Cox proportional-hazards regression model, stratified by disease status at baseline (measurable vs. non measurable disease) and platinum resistant vs platinum refractory disease at baseline.~HR calculated as Volasertib (BI 6727) /Cytotoxic"|||1.42|0.63|
72503082|NCT01121406|144536636|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.12|||||TWO_SIDED|95.0|0.73|1.7|||||"Cox proportional-hazards regression model, stratified by disease status at baseline (measurable vs. non measurable disease) and platinum resistant vs platinum refractory disease at baseline.~HR calculated as Volasertib (BI 6727)/ Cytotoxic"|||1.70|0.73|
72503083|NCT01121406|144536637|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.8|||||TWO_SIDED|95.0|0.4|1.61|||||"Cox proportional-hazards regression model, stratified by disease status at baseline (measurable vs. non measurable disease) and platinum resistant vs platinum refractory disease at baseline.~HR calculated as Volasertib (BI 6727)/ Cytotoxic"|||1.61|0.40|
72503084|NCT01121406|144536638|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.78|||||TWO_SIDED|95.0|0.37|1.65|||||"Cox proportional-hazards regression model, stratified by disease status at baseline (measurable vs. non measurable disease) and platinum resistant vs platinum refractory disease at baseline.~HR calculated as Volasertib (BI 6727)/ Cytotoxic"|||1.65|0.37|
72503085|NCT01121406|144536639|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.86|||||TWO_SIDED|95.0|0.39|1.93|||||"Cox proportional-hazards regression model, stratified by disease status at baseline (measurable vs. non measurable disease) and platinum resistant vs platinum refractory disease at baseline.~HR calculated as Volasertib (BI 6727)/ Cytotoxic"|||1.93|0.39|
72621474|NCT02732145|144773199|EQUIVALENCE|Question: Is there a difference in the incidence of aceto-whitening of the Clitoris among patients from different groups, with positive AWR?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of aceto-whitening of the Clitoris among patients from different groups, with positive AWR.||||0.0000
72465964|NCT00943722|144454767|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the difference in percentages between lots be entirely contained within the interval (-5, 5).|Percentage Point Difference|0.0|||||TWO_SIDED|95.0|-0.7|0.7|||||Percentage Point Difference = 9- to 15-Year-Old Females (Lot 1) minus 9- to 15-Year-Old Females (Lot 2)|Anti-HPV 33||0.7|-0.7|
72465965|NCT00943722|144454767|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the difference in percentages between lots be entirely contained within the interval (-5, 5).|Percentage Point Difference|0.4|||||TWO_SIDED|95.0|-0.4|1.3|||||Percentage Point Difference = 9- to 15-Year-Old Females (Lot 1) minus 9- to 15-Year-Old Females (Lot 3)|Anti-HPV 33||1.3|-0.4|
72465966|NCT00943722|144454767|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the difference in percentages between lots be entirely contained within the interval (-5, 5).|Percentage Point Difference|0.4|||||TWO_SIDED|95.0|-0.4|1.3|||||Percentage Point Difference = 9- to 15-Year-Old Females (Lot 2) minus 9- to 15-Year-Old Females (Lot 3)|Anti-HPV 33||1.3|-0.4|
72465967|NCT00943722|144454767|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the difference in percentages between lots be entirely contained within the interval (-5, 5).|Percentage Point Difference|-0.2|||||TWO_SIDED|95.0|-1.1|0.5|||||Percentage Point Difference = 9- to 15-Year-Old Females (Lot 1) minus 9- to 15-Year-Old Females (Lot 2)|Anti-HPV 45||0.5|-1.1|
72503086|NCT01121406|144536640|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.69|||||TWO_SIDED|95.0|0.33|1.47|||||"Cox proportional-hazards regression model, stratified by disease status at baseline (measurable vs. non measurable disease) and platinum resistant vs platinum refractory disease at baseline.~HR calculated as Volasertib (BI 6727)/ Cytotoxic"|||1.47|0.33|
72503087|NCT01121406|144536641|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.27|||||TWO_SIDED|95.0|0.09|0.77|||||"Cox proportional-hazards regression model, stratified by disease status at baseline (measurable vs. non measurable disease) and platinum resistant vs platinum refractory disease at baseline.~HR calculated as Volasertib (BI 6727)/ Cytotoxic"|||0.77|0.09|
72503088|NCT01078753|144536660|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|1.813||||0.009|TWO_SIDED|95.0|0.462|3.163||Desmopressin was considered to be superior to Placebo if the p-value for the comparison was \< 0.05 and the reduction from Baseline in number of wet nights was larger in the FE992026 group than in the Placebo group.|ANCOVA|Factors in the analysis were Gender (male, female), age (6≤x≤9, 10≤x≤15), number of wet nights at Baseline (10≤x≤13, x=14), and treatment group.||||3.163|0.462|0.009
72503089|NCT01078753|144536661|SUPERIORITY_OR_OTHER||Least Squares mean Difference|1.629||||0.018|TWO_SIDED|95.0|0.287|2.972|||ANCOVA|Factors in the analysis were Gender (male, female), age (6≤x≤9, 10≤x≤15), number of wet nights at Baseline (10≤x≤13, x=14), and treatment group.||||2.972|0.287|0.018
72503090|NCT01078753|144536662|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.183||||0.752|TWO_SIDED|95.0|-0.968|1.335|||ANCOVA|Factors in the analysis included Gender (male, female), age (6≤x≤9, 10≤x≤15), number of wet nights at Baseline (10≤x≤13, x=14), and treatment group.||||1.335|-0.968|0.752
72503091|NCT03826914|144536680|SUPERIORITY||Median Difference (Net)|-0.43||||0.042|TWO_SIDED|95.0|-0.846|-0.015||The threshold of significance was P=0.05|Anaylsis of Covariance||Placebo - Cardioflex|The primary analysis was conducted using the post-treatment biomarker value, comparing the two groups, and controlling for their baseline values by using analysis of covariance. In this study, the dependent variable was the biomarkers being tested, the controlled independent variable was the treatment given and the uncontrolled variables were the baseline differences between participants.||-0.015|-0.846|0.042
72503092|NCT03826914|144536681|SUPERIORITY||Mean Difference (Final Values)|-6.772||||0.04|TWO_SIDED|95.0|-11.2|-2.24||The threshold of significance was P=0.05|Anaylsis of Covariance|||The primary analysis was conducted using the post-treatment biomarker value, comparing the two groups, and controlling for their baseline values by using analysis of covariance. In this study, the dependent variable was the biomarkers being tested, the controlled independent variable was the treatment given and the uncontrolled variables were the baseline differences between participants.||-2.24|-11.2|0.04
72503093|NCT04334148|144536682|OTHER|||||||0.2|||||||Fisher Exact|||||||0.200
72503094|NCT04334148|144536683|OTHER|||||||1|||||||Regression, Linear|||||||1.0
72503095|NCT04334148|144536684|SUPERIORITY|||||||0.802|||||||Chi-squared|||||||0.802
72621475|NCT02732145|144773199|EQUIVALENCE|Question: Is there a difference in the incidence of aceto-whitening of Hart's Line among patients from different groups, with positive AWR?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of aceto-whitening of Hart's Line among patients from different groups, with positive AWR.||||0.0000
72621476|NCT02732145|144773199|EQUIVALENCE|Question: Is there a difference in the incidence of aceto-whitening of the Urethral Sulcus among patients from different groups, with positive AWR?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of aceto-whitening of the Urethral Sulcus among patients from different groups, with positive AWR.||||0.0000
72503096|NCT00397150|144536720|SUPERIORITY_OR_OTHER||Prevalence ratio|2.29|||||TWO_SIDED|95.0|1.33|3.92||||||||3.92|1.33|
72503097|NCT00397150|144536725|SUPERIORITY_OR_OTHER||Prevalence ratio|1.89|||||TWO_SIDED|95.0|1.7|2.11||||||||2.11|1.70|
72503098|NCT00397150|144536726|SUPERIORITY_OR_OTHER||Prevalence ratio|1.72|||||TWO_SIDED|95.0|1.12|2.63||||||||2.63|1.12|
72503099|NCT00195351|144536731|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-4.0||||0.009||95.0|-13.1|5.1|||t-test, 2 sided|||||5.1|-13.1|0.009
72465968|NCT00943722|144454767|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the difference in percentages between lots be entirely contained within the interval (-5, 5).|Percentage Point Difference|0.2|||||TWO_SIDED|95.0|-0.7|1.1|||||Percentage Point Difference = 9- to 15-Year-Old Females (Lot 1) minus 9- to 15-Year-Old Females (Lot 3)|Anti-HPV 45||1.1|-0.7|
72503100|NCT00195351|144536732|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-3.4||||0.02||95.0|-14.5|7.8|||t-test, 2 sided|||||7.8|-14.5|0.020
72465969|NCT00943722|144454767|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the difference in percentages between lots be entirely contained within the interval (-5, 5).|Percentage Point Difference|0.4|||||TWO_SIDED|95.0|-0.4|1.3|||||Percentage Point Difference = 9- to 15-Year-Old Females (Lot 2) minus 9- to 15-Year-Old Females (Lot 3)|Anti-HPV 45||1.3|-0.4|
72465970|NCT00943722|144454767|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the difference in percentages between lots be entirely contained within the interval (-5, 5).|Percentage Point Difference|0.0|||||TWO_SIDED|95.0|-0.7|0.7|||||Percentage Point Difference = 9- to 15-Year-Old Females (Lot 1) minus 9- to 15-Year-Old Females (Lot 2)|Anti-HPV 52||0.7|-0.7|
72503101|NCT00195351|144536733|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-2.9||||0.015||95.0|-13.9|8.1|||Method of Mehrotra and Railkar|||||8.1|-13.9|0.015
72621477|NCT02732145|144773199|EQUIVALENCE|Question: Is there a difference in the incidence of aceto-whitening of the Urethral Meatus among patients from different groups, with positive AWR?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of aceto-whitening of the Urethral Meatus among patients from different groups, with positive AWR.||||0.0000
72465971|NCT00943722|144454767|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the difference in percentages between lots be entirely contained within the interval (-5, 5).|Percentage Point Difference|0.3|||||TWO_SIDED|95.0|-0.4|1.3|||||Percentage Point Difference = 9- to 15-Year-Old Females (Lot 1) minus 9- to 15-Year-Old Females (Lot 3)|Anti-HPV 52||1.3|-0.4|
72465972|NCT00943722|144454767|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the difference in percentages between lots be entirely contained within the interval (-5, 5).|Percentage Point Difference|0.4|||||TWO_SIDED|95.0|-0.4|1.3|||||Percentage Point Difference = 9- to 15-Year-Old Females (Lot 2) minus 9- to 15-Year-Old Females (Lot 3)|Anti-HPV 52||1.3|-0.4|
72465973|NCT00943722|144454767|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the difference in percentages between lots be entirely contained within the interval (-5, 5).|Percentage Point Difference|0.0|||||TWO_SIDED|95.0|-0.7|0.7|||||Percentage Point Difference = 9- to 15-Year-Old Females (Lot 1) minus 9- to 15-Year-Old Females (Lot 2)|Anti-HPV 58||0.7|-0.7|
72465974|NCT00943722|144454767|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the difference in percentages between lots be entirely contained within the interval (-5, 5).|Percentage Point Difference|0.4|||||TWO_SIDED|95.0|-0.4|1.3|||||Percentage Point Difference = 9- to 15-Year-Old Females (Lot 1) minus 9- to 15-Year-Old Females (Lot 3)|Anti-HPV 58||1.3|-0.4|
72465975|NCT00943722|144454767|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the difference in percentages between lots be entirely contained within the interval (-5, 5).|Percentage Point Difference|0.4|||||TWO_SIDED|95.0|-0.4|1.3|||||Percentage Point Difference = 9- to 15-Year-Old Females (Lot 2) minus 9- to 15-Year-Old Females (Lot 3)|Anti-HPV 58||1.3|-0.4|
72465976|NCT01036165|144454779|SUPERIORITY_OR_OTHER||Mean positive response|0.78|||||TWO_SIDED|95.0|0.7|0.86|||||Confidence Interval calculated from normal approximation to the binomial. The primary objective was met if the lower limit of the 95% confidence interval was \>0.50.|||0.86|0.70|
72503102|NCT05300087|144536738|EQUIVALENCE|Bioequivalence would be demonstrated if the 90% confidence interval for the ratio of geometric means for Cmax between the test and reference products were completely contained within the FDA defined acceptance range of 80.00%-125.00%.|Ratio of geometric least square mean|1.014|||<|0.0001|TWO_SIDED|90.0|0.947|1.085|||ANOVA|||||1.085|0.947|<0.0001
72503103|NCT05300087|144536739|EQUIVALENCE|Bioequivalence would be demonstrated if the 90% confidence interval for the ratio of geometric means for AUC(0-t) between the test and reference products were completely contained within the FDA defined acceptance range of 80.00%-125.00%.|Ratio of geometric least square mean|1.022|||<|0.0001|TWO_SIDED|90.0|0.993|1.051|||ANOVA|||||1.051|0.993|<0.0001
72503104|NCT05300087|144536740|EQUIVALENCE|Bioequivalence would be demonstrated if the 90% confidence interval for the ratio of geometric means for AUC(0-inf) between the test and reference products were completely contained within the FDA defined acceptance range of 80.00%-125.00%.|Ratio of geometric least square mean|1.021|||<|0.0001|TWO_SIDED|90.0|0.994|1.048|||ANOVA|||||1.048|0.994|<0.0001
72621478|NCT02732145|144773199|EQUIVALENCE|Question: Is there a difference in the incidence of aceto-whitening of Hymenal Remnants among patients from different groups, with positive AWR?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of aceto-whitening of Hymenal Remnants among patients from different groups, with positive AWR.||||0.0000
72621479|NCT02732145|144773199|EQUIVALENCE|Question: Is there a difference in the incidence of aceto-whitening of Bartholin's Gland Opening among patients from different groups, with positive AWR?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of aceto-whitening of Bartholin's Gland Opening among patients from different groups, with positive AWR.||||0.0000
72465977|NCT01387815|144454791|OTHER||||||<|0.001|||||||Chi-squared|||Comparison does not include missing.||||<0.001
72465978|NCT01387815|144454792|OTHER||||||<|0.001|||||||Log Rank|||||||<0.001
72465979|NCT01387815|144454793|OTHER||||||<|0.001|||||||Chi-squared|||||||<0.001
72465980|NCT01387815|144454794|OTHER||||||<|0.001|||||||Chi-squared|||||||<0.001
72465981|NCT01387815|144454795|OTHER||||||<|0.001|||||||Chi-squared|||||||<0.001
72465982|NCT01387815|144454796|OTHER||||||<|0.001|||||||Chi-squared|||||||<0.001
72465983|NCT01387815|144454797|OTHER|||||||0.003|||||||t-test, 2 sided|||||||0.003
72465984|NCT01387815|144454798|OTHER|||||||0.016|||||||t-test, 2 sided|||||||0.016
72465985|NCT01387815|144454799|OTHER|||||||0.06|||||||t-test, 2 sided|||||||0.060
72465986|NCT01387815|144454800|OTHER|||||||0.056|||||||t-test, 2 sided|||||||0.056
72465987|NCT01387815|144454801|OTHER|||||||0.755|||||||t-test, 2 sided|||||||0.755
72465988|NCT01387815|144454802|OTHER|||||||0.091|||||||t-test, 2 sided|||||||0.091
72465989|NCT01387815|144454803|OTHER|||||||0.106|||||||t-test, 2 sided|||||||0.106
72465990|NCT01387815|144454804|OTHER|||||||0.003|||||||t-test, 2 sided|||||||0.003
72465991|NCT01387815|144454805|OTHER|||||||0.008|||||||t-test, 2 sided|||||||0.008
72465992|NCT01387815|144454806|OTHER|||||||0.083|||||||t-test, 2 sided|||||||0.083
72465993|NCT01387815|144454807|OTHER|||||||0.495|||||||t-test, 2 sided|||||||0.495
72465994|NCT01387815|144454808|OTHER|||||||0.097|||||||t-test, 2 sided|||||||0.097
72465995|NCT01387815|144454809|OTHER|||||||0.006|||||||t-test, 2 sided|||||||0.006
72465996|NCT01387815|144454810|OTHER|||||||0.037|||||||t-test, 2 sided|||||||0.037
72465997|NCT01387815|144454811|OTHER|||||||0.084|||||||t-test, 2 sided|||||||0.084
72465998|NCT01387815|144454812|OTHER|||||||0.09|||||||t-test, 2 sided|||||||0.090
72465999|NCT01387815|144454813|OTHER|||||||0.059|||||||t-test, 2 sided|||||||0.059
72466000|NCT01387815|144454814|OTHER|||||||0.004|||||||t-test, 2 sided|||||||0.004
72466001|NCT01387815|144454815|OTHER|||||||0.115|||||||t-test, 2 sided|||||||0.115
72466002|NCT01387815|144454816|OTHER|||||||0.002|||||||Log Rank|||||||0.002
72466003|NCT01387815|144454817|OTHER|||||||0.002|||||||Chi-squared|||"Comparison does not include the Missing category."||||0.002
72466004|NCT01387815|144454818|OTHER|"Comparison does not include the Missing category."||||||0.017|||||||Chi-squared|||||||0.017
72466005|NCT01387815|144454819|OTHER|||||||0.01||||||"Comparison does not include the Missing category."|Chi-squared|||||||0.010
72466006|NCT01387815|144454820|OTHER|||||||0.015|||||||Chi-squared|||"Comparison does not include the Missing category."||||0.015
72503105|NCT03248128|144536745|SUPERIORITY||Least Square Mean Difference|0.083|||<|0.001|TWO_SIDED|95.0|0.037|0.129|||ANCOVA|Analysis was performed using ANCOVA with covariates of baseline, region, sex, age and treatment.||||0.129|0.037|<0.001
72466007|NCT01387815|144454821|OTHER|||||||0.06|||||||Chi-squared|||"Comparison does not include the Missing category."||||0.060
72466008|NCT01387815|144454822|OTHER|||||||0.501|||||||t-test, 2 sided|||||||0.501
72466009|NCT01387815|144454823|OTHER|||||||0.807|||||||t-test, 2 sided|||||||0.807
72466010|NCT01387815|144454824|OTHER|||||||0.479|||||||t-test, 2 sided|||||||0.479
72466011|NCT01387815|144454825|OTHER|||||||0.918|||||||t-test, 2 sided|||||||0.918
72466012|NCT01387815|144454826|OTHER|||||||0.609|||||||t-test, 2 sided|||||||0.609
72466013|NCT01387815|144454827|OTHER|||||||0.367|||||||t-test, 2 sided|||||||0.367
72503106|NCT03248128|144536746|SUPERIORITY||Least Square Mean Difference|3.2||||0.228|TWO_SIDED|95.0|-2.0|8.4|||ANCOVA|Analysis was performed using analysis of covariance (ANCOVA) with covariates of baseline, region, sex, age and treatment.||||8.4|-2.0|0.228
72503107|NCT03248128|144536747|SUPERIORITY||Least Square Mean Difference|6.2||||0.011|TWO_SIDED|95.0|1.4|10.9|||ANCOVA|Analysis was performed using ANCOVA with covariates of baseline, region, sex, age and treatment.||||10.9|1.4|0.011
72503108|NCT03248128|144536748|SUPERIORITY||Least Square Mean Difference|0.073||||0.002|TWO_SIDED|95.0|0.028|0.118|||ANCOVA|Analysis was performed using ANCOVA with covariates of baseline, region, sex, age and treatment.||||0.118|0.028|0.002
72621480|NCT02732145|144773199|EQUIVALENCE|Question: Is there a difference in the incidence of aceto-whitening of the Vestibule among patients from different groups, with positive AWR?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of aceto-whitening of the Vestibule among patients from different groups, with positive AWR.||||0.0000
72370675|NCT00488683|144251642|SUPERIORITY_OR_OTHER||R-square|0.74||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and hSBA titers at 12 months of age for the serogroup Y||||
72370676|NCT00488683|144251642|SUPERIORITY_OR_OTHER||R-square|0.53||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between memory B cells one month after primary vaccination and hSBA titers at 12 months of age for the serogroup Y||||
72466014|NCT01387815|144454828|OTHER|||||||0.521|||||||t-test, 2 sided|||||||0.521
72466015|NCT01387815|144454829|OTHER|||||||0.793|||||||t-test, 2 sided|||||||0.793
72466016|NCT01387815|144454830|OTHER|||||||0.442|||||||t-test, 2 sided|||||||0.442
72466017|NCT01387815|144454831|OTHER|||||||0.434|||||||t-test, 2 sided|||||||0.434
72466018|NCT01387815|144454832|OTHER|||||||0.752|||||||t-test, 2 sided|||||||0.752
72466019|NCT01387815|144454833|OTHER|||||||0.469|||||||t-test, 2 sided|||||||0.469
72466020|NCT01387815|144454834|OTHER|||||||0.419|||||||t-test, 2 sided|||||||0.419
72466021|NCT01387815|144454835|OTHER|||||||0.695|||||||t-test, 2 sided|||||||0.695
72466022|NCT01387815|144454836|OTHER|||||||0.452|||||||t-test, 2 sided|||||||0.452
72466023|NCT01387815|144454837|OTHER|||||||0.008|||||||t-test, 2 sided|||||||0.008
72466024|NCT01387815|144454838|OTHER|||||||0.181|||||||t-test, 2 sided|||||||0.181
72466025|NCT01387815|144454839|OTHER|||||||0.252|||||||t-test, 2 sided|||||||0.252
72466026|NCT01387815|144454843|OTHER|||||||0.143|||||||Chi-squared|||||||0.143
72466027|NCT01387815|144454844|OTHER|||||||0.415|||||||Chi-squared|||||||0.415
72466028|NCT01387815|144454845|OTHER|||||||0.604|||||||Chi-squared|||||||0.604
72466029|NCT01387815|144454846|OTHER|||||||0.504|||||||Fisher Exact|||||||0.504
72466030|NCT01387815|144454847|OTHER|||||||0.92|||||||Chi-squared|||||||0.920
72466031|NCT01387815|144454848|OTHER||||||>|0.999|||||||Fisher Exact|||||||>0.999
72466032|NCT01387815|144454849|OTHER|||||||0.575|||||||Chi-squared|||||||0.575
72466033|NCT01387815|144454852|OTHER|||||||0.856|||||||Chi-squared|||||||0.856
72466034|NCT01387815|144454853|OTHER|||||||0.623|||||||Chi-squared|||||||0.623
72466035|NCT01387815|144454854|OTHER|||||||0.732|||||||Chi-squared|||||||0.732
72466036|NCT01387815|144454855|OTHER|||||||0.896|||||||t-test, 2 sided|||||||0.896
72466037|NCT01387815|144454856|OTHER|||||||0.879|||||||t-test, 2 sided|||||||0.879
72466038|NCT01387815|144454857|OTHER|||||||0.763|||||||t-test, 2 sided|||||||0.763
72466039|NCT01387815|144454858|OTHER|||||||0.657|||||||Chi-squared|||||||0.657
72466040|NCT01387815|144454859|OTHER|||||||0.987|||||||Chi-squared|||||||0.987
72466041|NCT01387815|144454860|OTHER|||||||0.011|||||||Fisher Exact|||||||0.011
72466042|NCT01387815|144454861|OTHER|||||||0.351|||||||t-test, 2 sided|||||||0.351
72466043|NCT01387815|144454862|OTHER|||||||0.835|||||||t-test, 2 sided|||||||0.835
72466044|NCT01387815|144454864|OTHER|||||||0.714|||||||Fisher Exact|||||||0.714
72466045|NCT01387815|144454865|OTHER|||||||0.737|||||||Fisher Exact|||||||0.737
72466046|NCT01387815|144454866|OTHER||||||>|0.999|||||||Fisher Exact|||||||>0.999
72466047|NCT01387815|144454870|OTHER||||||>|0.999|||||||Fisher Exact|||||||>0.999
72466048|NCT01387815|144454871|OTHER||||||>|0.999|||||||Fisher Exact|||||||>0.999
72466049|NCT01387815|144454873|OTHER|||||||0.714|||||||Fisher Exact|||||||0.714
72466050|NCT01387815|144454874|OTHER|||||||0.747|||||||Fisher Exact|||||||0.747
72466051|NCT01387815|144454875|OTHER|||||||0.495|||||||Fisher Exact|||||||0.495
72466052|NCT01387815|144454879|OTHER|||||||0.364|||||||Fisher Exact|||||||0.364
72466053|NCT01387815|144454880|OTHER||||||>|0.999|||||||Fisher Exact|||||||>0.999
72466054|NCT01387815|144454881|OTHER|||||||0.723|||||||Fisher Exact|||||||0.723
72466055|NCT01387815|144454888|OTHER|||||||0.006|||||||t-test, 2 sided|||||||0.006
72466056|NCT01387815|144454889|OTHER|||||||0.672|||||||t-test, 2 sided|||||||0.672
72466057|NCT01387815|144454890|OTHER|||||||0.482|||||||t-test, 2 sided|||||||0.482
72503109|NCT03248128|144536749|SUPERIORITY||Least Square Mean Difference|-0.3||||0.87|TWO_SIDED|95.0|-4.5|3.8|||ANCOVA|Analysis was performed using ANCOVA with covariates of baseline, region, sex, age and treatment.||||3.8|-4.5|0.870
72503110|NCT03248128|144536750|SUPERIORITY||Least Square Mean Difference|0.0||||0.988|TWO_SIDED|95.0|-4.2|4.1|||ANCOVA|Analysis was performed using ANCOVA with covariates of baseline, region, sex, age and treatment.||||4.1|-4.2|0.988
72503111|NCT03248128|144536751|SUPERIORITY||Least Square Mean Difference|0.035||||0.124|TWO_SIDED|0.95|-0.01|0.08|||Repeated measures analysis|||Analysis was performed using a repeated measures analysis adjusted for baseline, region, sex, age, treatment, visit, visit by baseline interaction and visit by treatment group interaction.||0.080|-0.010|0.124
72394378|NCT01179568|144295700|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.21|||<|0.05|TWO_SIDED|95.0|0.82|1.81|||Regression, Logistic|Logistic regression with inverse probability weighting controlled for randomization stratification variables (site and baseline MDD) \& race/ethnicity||Our prespecified primary analysis was cross-sectional, comparing treatment response rates for CIT vs PLA at week 12 (aim 1), based on the intention-to-treat principle including all randomized participants. With 10% of 440 target enrollment lost to follow-up we had a power of 76-83% to detect predicted between-group difference in response (CGT with PLA, 40%; CGT with CIT, 60%; CIT 40%; and PLA 20%)||1.81|0.82|<0.05
72394379|NCT01179568|144295700|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.01|||<|0.05|TWO_SIDED|95.0|0.88|1.17|||Regression, Logistic|Logistic regression with inverse probability weighting controlled for randomization stratification variables (site and baseline MDD) \& race/ethnicity||Our prespecified primary analysis was cross-sectional, comparing treatment response rates for CIT with CGT vs PLA with CGT at week 20 (aim 2) based on the intention-to-treat principle including all randomized participants.||1.17|0.88|<0.05
72394380|NCT01179568|144295700|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.21|||<|0.05|TWO_SIDED|95.0|1.0|1.46|||Regression, Logistic|Logistic regression with inverse probability weighting controlled for randomization stratification variables (site and baseline MDD) \& race/ethnicity||Our prespecified primary analysis was cross-sectional, comparing treatment response rates for CIT with CGT vs CIT at week 20 (aim 3) based on the intention-to-treat principle including all randomized participants.||1.46|1|<0.05
72394381|NCT01179568|144295701|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.67|STANDARD_ERROR_OF_MEAN|2.04||0.74|TWO_SIDED|||||Pre-specified secondary analyses compared changes in ICG scores using a weighted linear regression, controlling for site, baseline MDD, \& race/ethnicity, and with inverse probability weighting to adjust for missing assessments.|Regression, Linear|||||||0.74
72394382|NCT01179568|144295702|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.26|STANDARD_ERROR_OF_MEAN|1.98||0.53|TWO_SIDED|||||Pre-specified secondary analyses compared changes in ICG scores using a weighted linear regression, controlling for site, baseline MDD, \& race/ethnicity, and with inverse probability weighting to adjust for missing assessments.|Regression, Linear|||||||.53
72394383|NCT01179568|144295702|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.37|STANDARD_ERROR_OF_MEAN|2.08|<|0.001|TWO_SIDED|||||Pre-specified secondary analyses compared changes in ICG scores using a weighted linear regression, controlling for site, baseline MDD, \& race/ethnicity, and with inverse probability weighting to adjust for missing assessments.|Regression, Linear|||||||<.001
72394384|NCT01179568|144295703|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.84|STANDARD_ERROR_OF_MEAN|1.57||0.59|TWO_SIDED|||||Pre-specified secondary analyses compared changes in WSAS scores using a weighted linear regression, controlling for site, baseline MDD, \& race/ethnicity, and with inverse probability weighting to adjust for missing assessments.|Regression, Linear|||||||.59
72394385|NCT01179568|144295704|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.2|STANDARD_ERROR_OF_MEAN|1.44||0.4|TWO_SIDED||||||Regression, Linear|||Pre-specified secondary analyses compared changes in WSAS scores using a weighted linear regression, controlling for site, baseline MDD, \& race/ethnicity, and with inverse probability weighting to adjust for missing assessments.||||.40
72394386|NCT01179568|144295704|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.13|STANDARD_ERROR_OF_MEAN|1.46||0.005|TWO_SIDED||||||Regression, Linear|||Pre-specified secondary analyses compared changes in WSAS scores using a weighted linear regression, controlling for site, baseline MDD, \& race/ethnicity, and with inverse probability weighting to adjust for missing assessments.||||.005
72394387|NCT00646776|144295707|SUPERIORITY_OR_OTHER||Point Estimate|1.477|||||TWO_SIDED|90.0|1.188|1.835|||ANOVA||Point estimates and 90% confidence intervals of treatment differences on the log scale were exponentiated to obtain estimates on the original scale.|||1.835|1.188|
72466058|NCT01387815|144454891|OTHER|||||||0.938|||||||t-test, 2 sided|||||||0.938
72466059|NCT01387815|144454892|OTHER|||||||0.144|||||||t-test, 2 sided|||||||0.144
72466060|NCT01387815|144454893|OTHER|||||||0.36|||||||t-test, 2 sided|||||||0.360
72466061|NCT01387815|144454894|OTHER|||||||0.808|||||||t-test, 2 sided|||||||0.808
72466062|NCT01387815|144454895|OTHER|||||||0.208|||||||t-test, 2 sided|||||||0.208
72466063|NCT01387815|144454896|OTHER|||||||0.184|||||||t-test, 2 sided|||||||0.184
72466064|NCT01387815|144454897|OTHER|||||||0.305|||||||t-test, 2 sided|||||||0.305
72466065|NCT01387815|144454899|OTHER|||||||0.757|||||||t-test, 2 sided|||||||0.757
72466066|NCT01387815|144454900|OTHER|||||||0.321|||||||t-test, 2 sided|||||||0.321
72466067|NCT01387815|144454901|OTHER|||||||0.181|||||||t-test, 2 sided|||||||0.181
72466068|NCT01387815|144454902|OTHER|||||||0.395|||||||t-test, 2 sided|||||||0.395
72466069|NCT01387815|144454904|OTHER|||||||0.739|||||||t-test, 2 sided|||||||0.739
72466070|NCT01387815|144454905|OTHER|||||||0.291|||||||t-test, 2 sided|||||||0.291
72466071|NCT00307164|144454938|SUPERIORITY_OR_OTHER_LEGACY|||||||0.64||95.0|||||Stratified Wilcoxon rank-sum test|Treatment groups were compared for change in limb fat using a two-sided stratified Wilcoxon rank-sum test (stratified by ARV used)||||||0.64
72466072|NCT00307164|144454939|SUPERIORITY_OR_OTHER_LEGACY|||||||0.17||95.0|||||Log Rank|||||||0.17
72466073|NCT00307164|144454941|SUPERIORITY_OR_OTHER_LEGACY|||||||0.25||95.0|||||Stratified Wilcoxon rank-sum test|||||||0.25
72466074|NCT00307164|144454943|SUPERIORITY_OR_OTHER_LEGACY|||||||0.88||95.0|||||Stratified Wilcoxon rank-sum test|||||||0.88
72466075|NCT00307164|144454944|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6||95.0|||||Stratified Wilcoxon rank-sum test|||||||0.60
72466076|NCT00307164|144454945|SUPERIORITY_OR_OTHER_LEGACY|||||||0.13||95.0|||||Stratified Wilcoxon rank-sum test|||||||0.13
72466077|NCT00307164|144454946|SUPERIORITY_OR_OTHER_LEGACY|||||||0.17||95.0|||||Stratified Wilcoxon rank-sum test|||||||0.17
72466078|NCT00307164|144454947|SUPERIORITY_OR_OTHER_LEGACY|||||||0.034||95.0|||||Stratified Wilcoxon rank-sum test|||||||0.034
72466079|NCT00307164|144454948|SUPERIORITY_OR_OTHER_LEGACY|||||||0.76||95.0|||||Stratified Wilcoxon rank-sum test|||||||0.76
72466080|NCT00307164|144454949|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1||95.0|||||Stratified Wilcoxon rank-sum test|||||||0.10
72466081|NCT00307164|144454950|SUPERIORITY_OR_OTHER_LEGACY|||||||0.43||95.0|||||Stratified Wilcoxon rank-sum test|||||||0.43
72466082|NCT00307164|144454951|SUPERIORITY_OR_OTHER_LEGACY|||||||0.17||95.0|||||Stratified Wilcoxon rank-sum test|||||||0.17
72466083|NCT00307164|144454952|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8||95.0|||||Stratified Wilcoxon rank-sum test|||||||0.80
72466084|NCT00307164|144454953|SUPERIORITY_OR_OTHER_LEGACY|||||||0.42||95.0|||||Stratified Wilcoxon rank-sum test|||||||0.42
72466085|NCT01193218|144455120|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.72|STANDARD_ERROR_OF_MEAN|0.08|<|0.0001|TWO_SIDED|95.0|-0.87|-0.57||the analyses were made sequentially compared with placebo from high dose of empagliflozin and the full significant level (5%) was maintained by the hierarchical procedure.|ANCOVA|'treatment', 'renal function', and 'number of previous antidiabetic medication' as a fixed effect and baseline HbA1c as a covariate||Difference calculated as empa 5mg minus placebo||-0.57|-0.87|<0.0001
72466086|NCT01193218|144455120|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|0.08|<|0.0001|TWO_SIDED|95.0|-0.85|-0.55||the analyses were made sequentially compared with placebo from high dose of empagliflozin and the full significant level (5%) was maintained by the hierarchical procedure.|ANCOVA|'treatment', 'renal function', and 'number of previous antidiabetic medication' as a fixed effect and baseline HbA1c as a covariate||Difference calculated as empa 10mg minus placebo||-0.55|-0.85|<0.0001
72466087|NCT01193218|144455120|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.95|STANDARD_ERROR_OF_MEAN|0.08|<|0.0001|TWO_SIDED|95.0|-1.1|-0.8||the analyses were made sequentially compared with placebo from high dose of empagliflozin and the full significant level (5%) was maintained by the hierarchical procedure.|ANCOVA|'treatment', 'renal function', and 'number of previous antidiabetic medication' as a fixed effect and baseline HbA1c as a covariate||Difference calculated as empa 25mg minus placebo||-0.80|-1.10|<0.0001
72466088|NCT01193218|144455120|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.91|STANDARD_ERROR_OF_MEAN|0.08|<|0.0001|TWO_SIDED|95.0|-1.06|-0.76||the analyses were made sequentially compared with placebo from high dose of empagliflozin and the full significant level (5%) was maintained by the hierarchical procedure.|ANCOVA|'treatment', 'renal function', and 'number of previous antidiabetic medication' as a fixed effect and baseline HbA1c as a covariate||Difference calculated as empa 50mg minus placebo||-0.76|-1.06|<0.0001
72466089|NCT01193218|144455121|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|19.367|||<|0.0001|TWO_SIDED|95.0|5.34|70.236|||Regression, Logistic|The model includes 'treatment', 'renal function', 'number of previous antidiabetic medications' and 'continuous baseline HbA1c'.||Odds ratio calculated as the odds of Empa 5mg divided by the odds of placebo||70.236|5.340|<0.0001
72466090|NCT01193218|144455121|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|10.889||||0.0003|TWO_SIDED|95.0|2.942|40.301|||Regression, Logistic|The model includes 'treatment', 'renal function', 'number of previous antidiabetic medications' and 'continuous baseline HbA1c'.||Odds ratio calculated as the odds of Empa 10mg divided by the odds of placebo||40.301|2.942|0.0003
72466091|NCT01193218|144455121|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|27.624|||<|0.0001|TWO_SIDED|95.0|7.601|99.99|||Regression, Logistic|The model includes 'treatment', 'renal function', 'number of previous antidiabetic medications' and 'continuous baseline HbA1c'.|The upper limit of confidence interval is actually \>99.99|Odds ratio calculated as the odds of Empa 25mg divided by the odds of placebo||99.99|7.601|<0.0001
72466092|NCT01193218|144455121|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|44.906|||<|0.0001|TWO_SIDED|95.0|12.12|99.99|||Regression, Logistic|The model includes 'treatment', 'renal function', 'number of previous antidiabetic medications' and 'continuous baseline HbA1c'.|The upper limit of confidence interval is actually \>99.99|Odds ratio calculated as the odds of Empa 50mg divided by the odds of placebo||99.99|12.120|<0.0001
72466093|NCT01193218|144455122|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-26.7|STANDARD_ERROR_OF_MEAN|2.5|<|0.0001|TWO_SIDED|95.0|-31.61|-21.8|||ANCOVA|treatment, renal function, number of previous antidiabetic medication as fixed effects, baseline fasting plasma glucose, baseline HbA1c as covariates||Difference calculated as empa 5mg minus placebo||-21.80|-31.61|<0.0001
72466094|NCT01193218|144455122|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-29.34|STANDARD_ERROR_OF_MEAN|2.5|<|0.0001|TWO_SIDED|95.0|-34.25|-24.42|||ANCOVA|treatment, renal function, number of previous antidiabetic medication as fixed effects, baseline fasting plasma glucose, baseline HbA1c as covariates||Difference calculated as empa 10mg minus placebo||-24.42|-34.25|<0.0001
72621481|NCT02732145|144773199|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of the Clitoris versus Hart's line in patients with vulvar dermatosis and positive AWR?||||||0.8545|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Clitoris versus Hart's line in patients with vulvar dermatosis and positive AWR.||||0.8545
72621482|NCT02732145|144773199|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of the Clitoris versus Urethral Sulcus in patients with vulvar dermatosis and positive AWR?||||||0.8569|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Clitoris versus Urethral Sulcus in patients with vulvar dermatosis and positive AWR.||||0.8569
72621483|NCT02732145|144773199|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of the Clitoris versus Urethral Meatus in patients with vulvar dermatosis and positive AWR?||||||0.2478|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Clitoris versus Urethral Meatus in patients with vulvar dermatosis and positive AWR.||||0.2478
72621484|NCT02732145|144773199|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of the Clitoris versus Hymenal Remnants in patients with vulvar dermatosis and positive AWR?||||||0.2478|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Clitoris versus Hymenal Remnants in patients with vulvar dermatosis and positive AWR.||||0.2478
72621485|NCT02732145|144773199|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of the Clitoris versus Bartholin's Gland Opening in patients with vulvar dermatosis and positive AWR?||||||0.1627|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Clitoris versus Bartholin's Gland Opening in patients with vulvar dermatosis and positive AWR.||||0.1627
72621486|NCT02732145|144773199|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of the Clitoris versus Vestibule in patients with vulvar dermatosis and positive AWR?||||||0.5943|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Clitoris versus Vestibule in patients with vulvar dermatosis and positive AWR.||||0.5943
72621487|NCT02732145|144773199|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Hart's Line versus Urethral Sulcus in patients with vulvar dermatosis and positive AWR?||||||0.7161|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Hart's Line versus Urethral Sulcus in patients with vulvar dermatosis and positive AWR.||||0.7161
72621488|NCT02732145|144773199|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Hart's Line versus Urethral Meatus in patients with vulvar dermatosis and positive AWR?||||||0.3301|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Hart's Line versus Urethral Meatus in patients with vulvar dermatosis and positive AWR.||||0.3301
72621489|NCT02732145|144773199|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Hart's Line versus Hymenal Remnants in patients with vulvar dermatosis and positive AWR?||||||0.3301|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Hart's Line versus Hymenal Remnants in patients with vulvar dermatosis and positive AWR.||||0.3301
72621490|NCT02732145|144773199|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Hart's Line versus Bartholin's Gland Opening in patients with vulvar dermatosis and positive AWR?||||||0.1627|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Hart's Line versus Bartholin's Gland Opening in patients with vulvar dermatosis and positive AWR.||||0.1627
72621491|NCT02732145|144773199|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Hart's Line versus Vestibule in patients with vulvar dermatosis and positive AWR?||||||0.4742|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Hart's Line versus Vestibule in patients with vulvar dermatosis and positive AWR.||||0.4742
72621492|NCT02732145|144773199|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Urethral Sulcus versus Urethral Meatus in patients with vulvar dermatosis and positive AWR?||||||0.1822|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Urethral Sulcus versus Urethral Meatus in patients with vulvar dermatosis and positive AWR.||||0.1822
72466095|NCT01193218|144455122|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-37.75|STANDARD_ERROR_OF_MEAN|2.5|<|0.0001|TWO_SIDED|95.0|-42.66|-32.84|||ANCOVA|treatment, renal function, number of previous antidiabetic medication as fixed effects, baseline fasting plasma glucose, baseline HbA1c as covariates||Difference calculated as empa 25mg minus placebo||-32.84|-42.66|<0.0001
72466096|NCT01193218|144455122|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-36.6|STANDARD_ERROR_OF_MEAN|2.5|<|0.0001|TWO_SIDED|95.0|-41.51|-31.69|||ANCOVA|treatment, renal function, number of previous antidiabetic medication as fixed effects, baseline fasting plasma glucose, baseline HbA1c as covariates||Difference calculated as empa 50mg minus placebo||-31.69|-41.51|<0.0001
72466097|NCT01424189|144455177|NON_INFERIORITY_OR_EQUIVALENCE|With 300 subjects in the ReSTOR Toric IOL test group and 150 subjects in the ReSTOR IOL control group, there was over 99% power to demonstrate that the upper 95% confidence limit for the observed difference in UCDVA between IOL groups was less than the clinical performance target of 0.1 logMAR units at Month 12, assuming the true difference between groups is zero. This was based on an assumed standard deviation for UCDVA of 0.16 logMAR units and a 1-sided, α=0.05 test.|Mean Difference (Final Values)|0.001|STANDARD_ERROR_OF_MEAN|0.013|||ONE_SIDED|95.0||0.03||||||||0.030||
72621493|NCT02732145|144773199|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Urethral Sulcus versus Hymenal Remnants in patients with vulvar dermatosis and positive AWR?||||||0.1822|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Urethral Sulcus versus Hymenal Remnants in patients with vulvar dermatosis and positive AWR.||||0.1822
72466098|NCT01424189|144455178|NON_INFERIORITY_OR_EQUIVALENCE|With 300 subjects in the ReSTOR Toric IOL test group and 150 subjects in the ReSTOR IOL control group, there was over 99% power to demonstrate that the upper 95% confidence limit for the observed difference in UCNVA between IOL groups was less than the clinical performance target of 0.1 logMAR units at Month 12, assuming the true difference between groups is zero. This estimate was based on an assumed standard deviation for UCNVA of 0.16 logMAR units and a 1-sided, α=0.05 test.|Mean Difference (Final Values)|-0.044|STANDARD_ERROR_OF_MEAN|0.015|||ONE_SIDED|95.0||-0.017||||||||-0.017||
72466099|NCT01077622|144455240|SUPERIORITY_OR_OTHER||percentage of participants|70.0|||||TWO_SIDED|95.0|34.8|93.3|||||SERC assessment|||93.3|34.8|
72621494|NCT02732145|144773199|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Hymenal Remnants versus Vestibule in patients with vulvar dermatosis and positive AWR?||||||0.0927|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Hymenal Remnants versus Vestibule in patients with vulvar dermatosis and positive AWR.||||0.0927
72621495|NCT02732145|144773199|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Bartholin's Gland Opening versus Vestibule in patients with vulvar dermatosis and positive AWR?||||||0.036|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Bartholin's Gland Opening versus Vestibule in patients with vulvar dermatosis and positive AWR.||||0.0360
72621496|NCT02732145|144773199|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of the Clitoris versus Hart's Line in patients with vulvodynia and positive AWR?||||||0.072|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Clitoris versus Hart's Line in patients with vulvodynia and positive AWR.||||0.0720
72621497|NCT02732145|144773199|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of the Clitoris versus Urethral Sulcus in patients with vulvodynia and positive AWR?||||||1|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Clitoris versus Urethral Sulcus in patients with vulvodynia and positive AWR.||||1.0000
72621498|NCT02732145|144773199|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of the Clitoris versus Urethral Meatus in patients with vulvodynia and positive AWR?||||||0.4833|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Clitoris versus Urethral Meatus in patients with vulvodynia and positive AWR.||||0.4833
72621499|NCT02732145|144773199|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of the Clitoris versus Hymenal Remnants in patients with vulvodynia and positive AWR?||||||0.3594|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Clitoris versus Hymenal Remnants in patients with vulvodynia and positive AWR.||||0.3594
72621500|NCT02732145|144773199|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of the Clitoris versus Bartholin's Gland Opening in patients with vulvodynia and positive AWR?||||||0.5987|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Clitoris versus Bartholin's Gland Opening in patients with vulvodynia and positive AWR.||||0.5987
72621501|NCT02732145|144773199|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of the Clitoris versus Vestibule in patients with vulvodynia and positive AWR?||||||0.4164|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Clitoris versus Vestibule in patients with vulvodynia and positive AWR.||||0.4164
72621502|NCT02732145|144773199|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Hart's Line versus Urethral Sulcus in patients with vulvodynia and positive AWR?||||||0.072|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Hart's Line versus Urethral Sulcus in patients with vulvodynia and positive AWR.||||0.0720
72621503|NCT02732145|144773199|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Hart's Line versus Urethral Meatus in patients with vulvodynia and positive AWR?||||||0.0148|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Hart's Line versus Urethral Meatus in patients with vulvodynia and positive AWR.||||0.0148
72621504|NCT02732145|144773199|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Hart's Line versus Hymenal Remnants in patients with vulvodynia and positive AWR?||||||0.0085|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Hart's Line versus Hymenal Remnants in patients with vulvodynia and positive AWR.||||0.0085
72621505|NCT02732145|144773199|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Hart's Line versus Bartholin's Gland Opening in patients with vulvodynia and positive AWR?||||||0.1918|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Hart's Line versus Bartholin's Gland Opening in patients with vulvodynia and positive AWR.||||0.1918
72621506|NCT02732145|144773199|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Hart's line versus Vestibule in patients with vulvodynia and positive AWR?||||||0.3037|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Hart's line versus Vestibule in patients with vulvodynia and positive AWR.||||0.3037
72621507|NCT02732145|144773199|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of the Urethral Sulcus versus Urethral Meatus in patients with vulvodynia and positive AWR?||||||0.4833|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Urethral Sulcus versus Urethral Meatus in patients with vulvodynia and positive AWR.||||0.4833
72370677|NCT00488683|144251642|SUPERIORITY_OR_OTHER||R-square|0.37||||||95.0|||||Regression, Linear|||Linear regression coefficient between demographic factors, memory B cells one month after primary vaccination and hSBA titers at 12 months of age for the serogroup A||||
72370678|NCT00488683|144251642|SUPERIORITY_OR_OTHER||R-square|0.14||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between demographic factors, memory B cells one month after primary vaccination and hSBA titers at 12 months of age for the serogroup A||||
72370679|NCT00488683|144251642|SUPERIORITY_OR_OTHER||R-square|0.13||||||95.0|||||Regression, Linear|||Linear regression coefficient between demographic factors, memory B cells one month after primary vaccination and hSBA titers at 12 months of age for the serogroup C||||
72370680|NCT00488683|144251642|SUPERIORITY_OR_OTHER||R-square|0.17||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between demographic factors, memory B cells one month after primary vaccination and hSBA titers at 12 months of age for the serogroup C||||
72370681|NCT00488683|144251642|SUPERIORITY_OR_OTHER||R-square|0.9||||||95.0|||||Regression, Linear|||Linear regression coefficient between demographic factors, memory B cells one month after primary vaccination and hSBA titers at 12 months of age for the serogroup W-135||||
72370682|NCT00488683|144251642|SUPERIORITY_OR_OTHER||R-square|0.78||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between demographic factors, memory B cells one month after primary vaccination and hSBA titers at 12 months of age for the serogroup W-135||||
72394388|NCT00646776|144295708|SUPERIORITY_OR_OTHER||Point Estimate|2.489|||||TWO_SIDED|90.0|2.025|3.06|||ANOVA||Point estimates and 90% confidence intervals of treatment differences on the log scale were exponentiated to obtain estimates on the original scale.|||3.060|2.025|
72394389|NCT00646776|144295709|SUPERIORITY_OR_OTHER||Point Estimate|1.402|||||TWO_SIDED|90.0|1.052|1.867|||ANOVA||Point estimates and 90% confidence intervals of treatment differences on the log scale were exponentiated to obtain estimates on the original scale.|||1.867|1.052|
72394390|NCT00646776|144295710|SUPERIORITY_OR_OTHER||Point Estimate|0.947|||||TWO_SIDED|90.0|0.817|1.098|||ANOVA|||||1.098|0.817|
72394391|NCT00646776|144295711|SUPERIORITY_OR_OTHER||Point Estimate|0.745||||0.0963|TWO_SIDED|90.0|0.5569|0.9967|||ANOVA|||||0.9967|0.5569|0.0963
72394392|NCT00646776|144295712|SUPERIORITY_OR_OTHER||Point Estimate|0.857|||||TWO_SIDED|90.0|0.723|1.015|||ANOVA|||||1.015|0.723|
72394393|NCT00646776|144295715|SUPERIORITY_OR_OTHER||Point Estimate|0.66|||||TWO_SIDED|90.0|0.538|0.809|||ANOVA|||||0.809|0.538|
72466100|NCT01077622|144455240|SUPERIORITY_OR_OTHER||percentage of participants|70.0|||||TWO_SIDED|95.0|34.8|93.3|||||Investigator assessment|||93.3|34.8|
72466101|NCT00424177|144455291|SUPERIORITY_OR_OTHER||Proportion of subjects in Cycle 2 or 3|0.87||||||95.0|0.74|0.94||||||||0.94|0.74|
72466102|NCT01123512|144455298|NON_INFERIORITY_OR_EQUIVALENCE|"Pr( Pt - Pc \> -12.5% \| data), calculated using Bayesian multiple imputation for missing 12-month values, as specified in the protocol. The Kiva System is declared non-inferior to control if Pr( Pt - Pc \> -12.5% \| data)\> 96.6%."|% Probability of Equivalence = 99.92|99.92|||||TWO_SIDED|||||"Pr( Pt - Pc \> -12.5% \| data), calculated using Bayesian multiple imputation for missing 12-month values, as specified in the protocol. The Kiva System is declared non-inferior to control if Pr( Pt - Pc \> -12.5% \| data)\> 96.6%."|Bayesian test of proportions|||||||
72466103|NCT00691678|144455306|SUPERIORITY||Mean Difference (Final Values)|-13.3||||0.004|TWO_SIDED||||||t-test, 2 sided|||This statistical analysis measures whether there is a statistically significant change, at the 5% significance level, between the mean WOMAC score among study participants at baseline and at week 24.||||0.004
72503112|NCT03248128|144536752|SUPERIORITY||Least Square Mean Difference|-0.01||||0.91|TWO_SIDED|95.0|-0.1|0.09|||Repeated measures analysis|||Analysis was performed using a repeated measures analysis adjusted for baseline, region, sex, age, treatment, visit, visit by baseline interaction and visit by treatment group interaction.||0.09|-0.10|0.910
72621508|NCT02732145|144773199|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of the Urethral Sulcus versus Hymenal Remnants in patients with vulvodynia and positive AWR?||||||0.3594|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Urethral Sulcus versus Hymenal Remnants in patients with vulvodynia and positive AWR.||||0.3594
72394394|NCT00646776|144295716|SUPERIORITY_OR_OTHER||Point Estimate|0.651|||||TWO_SIDED|90.0|0.43|0.986|||ANOVA|||||0.986|0.430|
72394395|NCT00646776|144295717|SUPERIORITY_OR_OTHER||Point Estimate|0.696|||||TWO_SIDED|90.0|0.563|0.862|||ANOVA|||||0.862|0.563|
72394396|NCT00646776|144295723|SUPERIORITY_OR_OTHER||Point Estimate|10.902|||||TWO_SIDED|90.0|8.135|14.61|||ANOVA|||||14.610|8.135|
72394397|NCT00646776|144295724|SUPERIORITY_OR_OTHER||Point Estimate|7.766|||||TWO_SIDED|90.0|6.133|9.833|||ANCOVA|||||9.833|6.133|
72394398|NCT00646776|144295725|SUPERIORITY_OR_OTHER||Point Estimate|11.451|||||TWO_SIDED|90.0|8.147|16.095|||ANOVA|||||16.095|8.147|
72394399|NCT00646776|144295726|SUPERIORITY_OR_OTHER||Point Estimate|2.19|||||TWO_SIDED|90.0|1.783|2.691|||ANOVA||Point estimates and 90% confidence intervals of treatment differences on the log scale were exponentiated to obtain estimates on the original scale.|||2.691|1.783|
72394400|NCT01753856|144295743|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|Analysis of covariance (ANCOVA) model with treatment group as the main effect and baseline MS/BS as a covariate.||||||<0.001
72394401|NCT01753856|144295744|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||DL and SL, in CC.|Fisher Exact|||||||<0.001
72394402|NCT01753856|144295744|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED|||||SL Only, in CC.|Fisher Exact|||||||0.002
72394403|NCT01753856|144295744|SUPERIORITY_OR_OTHER|||||||0.494|TWO_SIDED|||||No Label, in CC.|Fisher Exact|||||||0.494
72394404|NCT01753856|144295744|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED|||||DL and SL, in EC.|Fisher Exact|||||||0.001
72394405|NCT01753856|144295744|SUPERIORITY_OR_OTHER|||||||0.027|TWO_SIDED|||||SL Only, in EC.|Fisher Exact|||||||0.027
72394406|NCT01753856|144295744|SUPERIORITY_OR_OTHER|||||||0.118|TWO_SIDED|||||No Label, in EC.|Fisher Exact|||||||0.118
72394407|NCT01753856|144295744|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||DL and SL, in IC.|Fisher Exact|||||||<0.001
72394408|NCT01753856|144295744|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED|||||SL Only, in IC.|Fisher Exact|||||||0.001
72394409|NCT01753856|144295744|SUPERIORITY_OR_OTHER||||||>|0.999|TWO_SIDED|||||No Label, in IC.|Fisher Exact|||||||>0.999
72394410|NCT01753856|144295744|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED|||||DL and SL, in PC.|Fisher Exact|||||||0.002
72394411|NCT01753856|144295744|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||SL Only, in PC.|Fisher Exact|||||||<0.001
72394412|NCT01753856|144295744|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||No Label, in PC.|Fisher Exact|||||||<0.001
72466104|NCT02930837|144455307|SUPERIORITY||Percentage of patients|63.3|||<|0.0001|TWO_SIDED|95.0|54.42|71.42|||One-sample test||Percentage of patients with Favourable outcome|A null hypothesis of p ≤40% versus the alternative hypothesis of p \>40% was tested using a one sample test at two-sided significance level of 0.05, where p denoted the response rate in Chinese patients who were treated within 3-4.5 h after stroke onset.||71.42|54.42|<0.0001
72466105|NCT01502371|144455320|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|3.87||||0.019|TWO_SIDED|95.0|0.64|7.09||Constrained longitudinal data analysis (cLDA) model method proposed by Liang \& Zeger includes terms for treatment, time in weeks, age strata (age 5-6, 7-11), treatment by time interaction \& region (North America, Latin America \& the European Union)|cLDA model|||Change from Baseline in percent predicted FEV1 at Week 12: MF MDI 50 mcg BID vs. Placebo||7.09|0.64|0.019
72466106|NCT01502371|144455320|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|6.29|||<|0.001|TWO_SIDED|95.0|3.05|9.53||cLDA model method proposed by Liang \& Zeger includes terms for treatment, time in weeks, age strata (age 5-6, 7-11), treatment by time interaction \& region (North America, Latin America \& the European Union)|cLDA|||Change from Baseline in percent predicted FEV1 at Week 12: MF MDI 100 mcg BID vs. Placebo||9.53|3.05|<0.001
72503113|NCT03248128|144536753|SUPERIORITY||Least Square Mean Difference|1.3||||0.614|TWO_SIDED|95.0|-3.6|6.2|||ANCOVA|Analysis performed using ANCOVA with covariates of baseline, region, sex, age and treatment.||||6.2|-3.6|0.614
72394413|NCT01753856|144295745|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||EC.|ANCOVA|ANCOVA model with treatment group as the main effect and baseline MS/BS as a covariate.||||||<0.001
72466107|NCT01502371|144455320|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|5.34||||0.001|TWO_SIDED|95.0|2.07|8.61||cLDA model method proposed by Liang \& Zeger includes terms for treatment, time in weeks, age strata (age 5-6, 7-11), treatment by time interaction \& region (North America, Latin America \& the European Union)|cLDA|||Change from Baseline in percent predicted FEV1 at Week 12: MF MDI 200 mcg BID vs. Placebo||8.61|2.07|0.001
72394414|NCT01753856|144295745|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||IC.|ANCOVA|ANCOVA model with treatment group as the main effect and baseline MS/BS as a covariate.||||||<0.001
72394415|NCT01753856|144295745|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||PC.|ANCOVA|ANCOVA model with treatment group as the main effect and baseline MS/BS as a covariate.||||||<0.001
72394416|NCT01753856|144295746|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||CC.|Wilcoxon (Mann-Whitney)|||||||<0.001
72394417|NCT01753856|144295746|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||EC.|Wilcoxon (Mann-Whitney)|||||||<0.001
72394418|NCT01753856|144295746|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||IC.|Wilcoxon (Mann-Whitney)|||||||<0.001
72466108|NCT01502371|144455321|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|19.15||||0.045|TWO_SIDED|95.0|0.43|37.87||cLDA model method proposed by Liang \& Zeger includes terms for treatment, time in weeks, age strata (age 5-6, 7-11), treatment by time interaction \& region (North America, Latin America \& the European Union)|cLDA|||Change from Baseline in AM PEF: MF MDI 50 mcg BID vs. Placebo. Only participants who received MF MDI or Placebo were included in the statistical analysis.||37.87|0.43|0.045
72621509|NCT02732145|144773199|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of the Hymenal Remnants versus Vestibule in patients with vulvodynia and positive AWR?||||||0.0877|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Hymenal Remnants versus Vestibule in patients with vulvodynia and positive AWR.||||0.0877
72621510|NCT02732145|144773199|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Bartholin's Gland Opening versus Vestibule in patients with vulvodynia and positive AWR?||||||0.7726|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Bartholin's Gland Opening versus Vestibule in patients with vulvodynia and positive AWR.||||0.7726
72621511|NCT02732145|144773199|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of the Clitoris versus Hart's Line in patients with impaired vulvar skin and positive AWR?||||||0.0191|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Clitoris versus Hart's Line in patients with impaired vulvar skin and positive AWR.||||0.0191
72621512|NCT02732145|144773199|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of the Clitoris versus Urethral Sulcus in patients with impaired vulvar skin and positive AWR?||||||0.0287|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Clitoris versus Urethral Sulcus in patients with impaired vulvar skin and positive AWR.||||0.0287
72621513|NCT02732145|144773199|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of the Clitoris versus Urethral Meatus in patients with impaired vulvar skin and positive AWR?||||||0.6374|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Clitoris versus Urethral Meatus in patients with impaired vulvar skin and positive AWR.||||0.6374
72621514|NCT02732145|144773199|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of the Clitoris versus Hymenal Remnants in patients with impaired vulvar skin and positive AWR?||||||0.7512|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Clitoris versus Hymenal Remnants in patients with impaired vulvar skin and positive AWR.||||0.7512
72621515|NCT02732145|144773199|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of the Clitoris versus Bartholin's Gland Opening in patients with impaired vulvar skin and positive AWR?||||||0.2734|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Clitoris versus Bartholin's Gland Opening in patients with impaired vulvar skin and positive AWR.||||0.2734
72621516|NCT02732145|144773199|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of the Clitoris versus Vestibule in patients with impaired vulvar skin and positive AWR?||||||0.0287|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Clitoris versus Vestibule in patients with impaired vulvar skin and positive AWR.||||0.0287
72621517|NCT02732145|144773199|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Hart's Line versus Urethral Sulcus in patients with impaired vulvar skin and positive AWR?||||||0.8732|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Hart's Line versus Urethral Sulcus in patients with impaired vulvar skin and positive AWR.||||0.8732
72621518|NCT02732145|144773199|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Hart's Line versus Urethral Meatus in patients with impaired vulvar skin and positive AWR?||||||0.0602|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Hart's Line versus Urethral Meatus in patients with impaired vulvar skin and positive AWR.||||0.0602
72621519|NCT02732145|144773199|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Hart's Line versus Hymenal Remnants in patients with impaired vulvar skin and positive AWR?||||||0.0079|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Hart's Line versus Hymenal Remnants in patients with impaired vulvar skin and positive AWR.||||0.0079
72621520|NCT02732145|144773199|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Hart's Line versus Bartholin's Gland Opening in patients with impaired vulvar skin and positive AWR?||||||0.2081|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Hart's Line versus Bartholin's Gland Opening in patients with impaired vulvar skin and positive AWR.||||0.2081
72394419|NCT01753856|144295746|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||PC.|Wilcoxon (Mann-Whitney)|||||||<0.001
72394420|NCT01753856|144295747|SUPERIORITY_OR_OTHER|||||||0.74|TWO_SIDED|||||Remodeling-Based Bone Formation in the CC.|Wilcoxon (Mann-Whitney)|||||||0.740
72394421|NCT01753856|144295747|SUPERIORITY_OR_OTHER|||||||0.74|TWO_SIDED|||||Modeling-Based Bone Formation in the CC.|Wilcoxon (Mann-Whitney)|||||||0.740
72503114|NCT03248128|144536754|SUPERIORITY||Least Square Mean Difference|1.3||||0.594|TWO_SIDED|95.0|-3.6|6.3|||ANCOVA|Analysis was performed using ANCOVA with covariates of baseline, region, sex, age and treatment.||||6.3|-3.6|0.594
72503115|NCT03248128|144536755|SUPERIORITY||Least Square Mean Difference|0.028||||0.226|TWO_SIDED|95.0|-0.017|0.073|||Repeated measures analysis|||Analysis was performed using a repeated measures analysis adjusted for baseline, region, sex, age, treatment, visit, visit by baseline interaction and visit by treatment group interaction.||0.073|-0.017|0.226
72503116|NCT03248128|144536756|SUPERIORITY||Least Square Mean Difference|-0.02||||0.663|TWO_SIDED|95.0|-0.13|0.09|||Repeated measures analysis|||Analysis was performed using a repeated measures analysis adjusted for baseline, region, sex, age, treatment, visit, visit by baseline interaction and visit by treatment group interaction.||0.09|-0.13|0.663
72503117|NCT03875235|144536791|SUPERIORITY||Hazard Ratio (HR)|0.8||||0.021|TWO_SIDED|97.0|0.64|0.99||The analysis was performed using a stratified log-rank test adjusting for disease status (initially unresectable versus recurrent) and primary tumor location (IHCC versus EHCC versus GBC), and tested at 0.03 significance level.|Log Rank||The HR and CI were estimated from a stratified Cox proportional hazard model adjusting for disease status and primary tumor location.|The 2-sided significance level for OS at the second interim analysis was 3%.|95% CI 0.66 to 0.97|0.99|0.64|0.021
72503118|NCT03875235|144536794|SUPERIORITY||Hazard Ratio (HR)|0.75||||0.001|TWO_SIDED|95.19|0.63|0.89||The p-value is based on a stratified log-rank test adjusting for disease status (initially unresectable versus recurrent) and primary tumor location (IHCC versus EHCC versus GBC), and tested at 0.0481 significance level.|Log Rank||The HR and CI were estimated from a stratified Cox proportional hazard model adjusting for disease status and primary tumor location.|The 2-sided significance level for PFS at the second interim analysis was 4.81%.|95% CI 0.63 to 0.89|0.89|0.63|0.001
72503119|NCT03875235|144536797|SUPERIORITY||Odds Ratio (OR)|1.6||||0.011|TWO_SIDED|95.0|1.11|2.31|||Cochran-Mantel-Haenszel||OR and CI were estimated from a stratified CMH test adjusting for disease status and primary tumor location.|||2.31|1.11|0.011
72503120|NCT02625402|144536806|EQUIVALENCE|Knowledge scores within 10% points|Mean Difference (Final Values)|6.4|STANDARD_ERROR_OF_MEAN|7.6|<|0.05|TWO_SIDED|95.0|-8.8|21.5|||t-test, 2 sided|||||21.5|-8.8|<0.05
72503121|NCT01877655|144536809|SUPERIORITY||Odds Ratio (OR)|1.27||||0.205|TWO_SIDED|95.0|0.87|1.85||P-value based on CMH general association test stratified by donor-recipient relatedness and donor CMV serostatus.|Cochran-Mantel-Haenszel||Odds ratio (ASP0113 vs placebo) and 95% CI was based on CMH general association test stratified by donor-recipient relatedness \& donor CMV serostatus.|Analysis of all-cause mortality and adjudicated CMV EOD. Analysis was completed using the Cochran-Mantel-Haenszel (CMH) test at the 1-sided 5% level stratified by use of antithymocyte globulin (ATG) and by receipt of a kidney from a living or deceased donor.||1.85|0.87|0.205
72503122|NCT01877655|144536810|SUPERIORITY||Hazard Ratio (HR)|0.96||||0.748|TWO_SIDED|95.0|0.76|1.22||P-value based on cox proportional hazards model parameter estimate for the treatment effect.|Cox Proportional Hazard Model|Parameter estimate from cox proportional hazard model (ASP0113 v placebo) with treatment \& randomization strata adjusted for death as a competing risk||Analysis of CMV viremia through 1 year posttransplant. CMV viremia was defined by the protocol as CMV plasma viral load ≥ 1000 IU/mL as assessed by the central laboratory. The 95% CI was based on cumulative incidence function CMV viremia rate at 1 year.||1.22|0.76|0.748
72621521|NCT02732145|144773199|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Hart's Line versus Vestibule in patients with impaired vulvar skin and positive AWR?||||||0.8732|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Hart's Line versus Vestibule in patients with impaired vulvar skin and positive AWR.||||0.8732
72621522|NCT02732145|144773199|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of the Urethral Sulcus versus Urethral Meatus in patients with impaired vulvar skin and positive AWR?||||||0.0852|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Urethral Sulcus versus Urethral Meatus in patients with impaired vulvar skin and positive AWR.||||0.0852
72394422|NCT01753856|144295747|SUPERIORITY_OR_OTHER|||||||0.008|TWO_SIDED|||||Remodeling-Based Bone Formation in the EC.|Wilcoxon (Mann-Whitney)|||||||0.008
72621523|NCT02732145|144773199|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of the Urethral Sulcus versus Hymenal Remnants in patients with impaired vulvar skin and positive AWR?||||||0.0125|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Urethral Sulcus versus Hymenal Remnants in patients with impaired vulvar skin and positive AWR.||||0.0125
72621524|NCT02732145|144773199|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Hymenal Remnants versus Vestibule in patients with impaired vulvar skin and positive AWR?||||||0.0125|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Hymenal Remnants versus Vestibule in patients with impaired vulvar skin and positive AWR.||||0.0125
72621525|NCT02732145|144773199|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Bartholin's Gland Opening versus Vestibule in patients with impaired vulvar skin and positive AWR?||||||0.2714|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Bartholin's Gland Opening versus Vestibule in patients with impaired vulvar skin and positive AWR.||||0.2714
72621526|NCT02732145|144773199|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of the Clitoris versus Hart's Line in patients with normal vulva and positive AWR?||||||0.1692|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Clitoris versus Hart's Line in patients with normal vulva and positive AWR.||||0.1692
72621527|NCT02732145|144773199|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of the Clitoris versus Urethral Sulcus in patients with normal vulva and positive AWR?||||||0.0772|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Clitoris versus Urethral Sulcus in patients with normal vulva and positive AWR.||||0.0772
72503123|NCT01877655|144536811|SUPERIORITY||Hazard Ratio (HR)|1.02||||0.888|TWO_SIDED|95.0|0.8|1.29||P-value based on cox proportional hazards model parameter estimate for the treatment effect.|Cox Proportional Hazard Model|Parameter estimate from cox proportional hazard model (ASP0113 v placebo) with treatment \& randomization strata adjusted for death as a competing risk||Analysis of CMV-specific antiviral therapy (AVT) through 1 year. Time to first adjudicated CMV-specific therapy was defined as time to the start of AVT for CMV viremia. CMV-specific AVT was determined by the adjudication committee. Rate was based on cumulative incidence function estimate at 1 year.||1.29|0.80|0.888
72466109|NCT01502371|144455321|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|27.35||||0.004|TWO_SIDED|95.0|8.63|46.08||cLDA model method proposed by Liang \& Zeger includes terms for treatment, time in weeks, age strata (age 5-6, 7-11), treatment by time interaction \& region (North America, Latin America \& the European Union)|cLDA|||Change from Baseline in AM PEF: MF MDI 100 mcg BID vs. Placebo. Only participants who received MF MDI or Placebo were included in the statistical analysis.||46.08|8.63|0.004
72466110|NCT01502371|144455321|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|18.01||||0.057|TWO_SIDED|95.0|-0.51|36.53||cLDA model method proposed by Liang \& Zeger includes terms for treatment, time in weeks, age strata (age 5-6, 7-11), treatment by time interaction \& region (North America, Latin America \& the European Union)|cLDA|||Change from Baseline in AM PEF: MF MDI 200 mcg BID vs. Placebo. Only participants who received MF MDI or Placebo were included in the statistical analysis.||36.53|-0.51|0.057
72466111|NCT01502371|144455322|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.1||||0.28|TWO_SIDED|95.0|-0.08|0.27||cLDA model method proposed by Liang \& Zeger includes terms for treatment, time in weeks, age strata (age 5-6, 7-11), treatment by time interaction \& region (North America, Latin America \& the European Union)|cLDA|||Change from Baseline in PAQLQ(S) Total Score: MF MDI 50 mcg BID vs. Placebo. Only participants who received MF MDI or Placebo were included in the statistical analysis.||0.27|-0.08|0.280
72466112|NCT01502371|144455322|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.12||||0.178|TWO_SIDED|95.0|-0.06|0.3||cLDA model method proposed by Liang \& Zeger includes terms for treatment, time in weeks, age strata (age 5-6, 7-11), treatment by time interaction \& region (North America, Latin America \& the European Union)|cLDA|||Change from Baseline in PAQLQ(S) Total Score: MF MDI 100 mcg BID vs. Placebo. Only participants who received MF MDI or Placebo were included in the statistical analysis.||0.30|-0.06|0.178
72394423|NCT01753856|144295747|SUPERIORITY_OR_OTHER|||||||0.008|TWO_SIDED|||||Modeling-Based Bone Formation in the EC.|Wilcoxon (Mann-Whitney)|||||||0.008
72466113|NCT01502371|144455322|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.18||||0.045|TWO_SIDED|95.0|0.0|0.36||cLDA model method proposed by Liang \& Zeger includes terms for treatment, time in weeks, age strata (age 5-6, 7-11), treatment by time interaction \& region (North America, Latin America \& the European Union)|cLDA|||Change from Baseline in PAQLQ(S) Total Score: MF MDI 200 mcg BID vs. Placebo. Only participants who received MF MDI or Placebo were included in the statistical analysis.||0.36|0.00|0.045
72394424|NCT01753856|144295747|SUPERIORITY_OR_OTHER|||||||0.661|TWO_SIDED|||||Remodeling-Based Bone Formation in the PC.|Wilcoxon (Mann-Whitney)|||||||0.661
72394425|NCT01753856|144295747|SUPERIORITY_OR_OTHER|||||||0.661|TWO_SIDED|||||Modeling-Based Bone Formation in the PC.|Wilcoxon (Mann-Whitney)|||||||0.661
72394426|NCT01753856|144295749|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||CC.|Wilcoxon (Mann-Whitney)|||||||<0.001
72394427|NCT01753856|144295749|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||EC.|Wilcoxon (Mann-Whitney)|||||||<0.001
72466114|NCT01502371|144455323|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|1.39||||0.368|TWO_SIDED|95.0|-1.65|4.44||cLDA model method proposed by Liang \& Zeger includes terms for treatment, time in weeks, age strata (age 5-6, 7-11), treatment by time interaction \& region (North America, Latin America \& the European Union)|cLDA model|||Change from Baseline in percent predicted FEV1 at Week 12: MF MDI 50 mcg BID vs. MF DPI 100 mcg QD. Only participants who received MF MDI 50 mcg BID or MF DPI 100 mcg QD were included in the statistical analysis.||4.44|-1.65|0.368
72621528|NCT02732145|144773199|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of the Clitoris versus Urethral Meatus in patients with normal vulva and positive AWR?||||||0.5762|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Clitoris versus Urethral Meatus in patients with normal vulva and positive AWR.||||0.5762
72621529|NCT02732145|144773199|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of the Clitoris versus Hymenal Remnants in patients with normal vulva and positive AWR?||||||0.5762|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Clitoris versus Hymenal Remnants in patients with normal vulva and positive AWR.||||0.5762
72621530|NCT02732145|144773199|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of the Clitoris versus Bartholin's Gland Opening in patients with normal vulva and positive AWR?||||||1|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Clitoris versus Bartholin's Gland Opening in patients with normal vulva and positive AWR.||||1.0000
72621531|NCT02732145|144773199|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of the Clitoris versus Vestibule in patients with normal vulva and positive AWR?||||||0.0078|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Clitoris versus Vestibule in patients with normal vulva and positive AWR.||||0.0078
72621532|NCT02732145|144773199|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Hart's Line versus Urethral Sulcus in patients with normal vulva and positive AWR?||||||0.6862|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Hart's Line versus Urethral Sulcus in patients with normal vulva and positive AWR.||||0.6862
72621533|NCT02732145|144773199|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Hart's Line versus Urethral Meatus in patients with normal vulva and positive AWR?||||||0.0563|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Hart's Line versus Urethral Meatus in patients with normal vulva and positive AWR.||||0.0563
72621534|NCT02732145|144773199|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Hart's Line versus Hymenal Remnants in patients with normal vulva and positive AWR?||||||0.0563|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Hart's Line versus Hymenal Remnants in patients with normal vulva and positive AWR.||||0.0563
72621535|NCT02732145|144773199|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Hart's Line versus Bartholin's Gland Opening in patients with normal vulva and positive AWR?||||||0.1692|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Hart's Line versus Bartholin's Gland Opening in patients with normal vulva and positive AWR.||||0.1692
72621536|NCT02732145|144773199|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Hart's Line versus Vestibule in patients with normal vulva and positive AWR?||||||0.1822|||||||t|||Parameter: The difference in the incidence of aceto-whitening of Hart's Line versus Vestibule in patients with normal vulva and positive AWR.||||0.1822
72621537|NCT02732145|144773199|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Urethral Sulcus versus Urethral Meatus in patients with normal vulva and positive AWR?||||||0.022|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Urethral Sulcus versus Urethral Meatus in patients with normal vulva and positive AWR.||||0.0220
72621538|NCT02732145|144773199|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Urethral Sulcus versus Hymenal Remnants in patients with normal vulva and positive AWR?||||||0.022|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Urethral Sulcus versus Hymenal Remnants in patients with normal vulva and positive AWR.||||0.0220
72394428|NCT01753856|144295749|SUPERIORITY_OR_OTHER|||||||0.74|TWO_SIDED|||||PC.|Wilcoxon (Mann-Whitney)|||||||0.740
72394429|NCT01753856|144295750|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||CC.|ANCOVA|ANCOVA model with treatment group as the main effect and baseline as a covariate.||||||<0.001
72394430|NCT01753856|144295750|SUPERIORITY_OR_OTHER|||||||0.004|TWO_SIDED|||||EC.|ANCOVA|ANCOVA model with treatment group as the main effect and baseline as a covariate.||||||0.004
72466115|NCT00511836|144455345|SUPERIORITY_OR_OTHER||||||<|2e-05|||||||t-test, 1 sided|||Null hypothesis: mean treatment difference=0.||||<0.00002
72466116|NCT00511836|144455348|SUPERIORITY_OR_OTHER||||||<|0.013|||||||t-test, 1 sided|||Null hypothesis: mean treatment difference=0||||<0.013
72466117|NCT00511836|144455349|SUPERIORITY_OR_OTHER|||||||0.245|||||||t-test, 1 sided|||Null hypothesis: mean treatment difference=0||||0.245
72466118|NCT01936324|144455350|OTHER|||||||0.0003|||||||ANCOVA|ANCOVA model with terms of treatment, baseline lesion count, and center.||||||0.0003
72466119|NCT01936324|144455351|OTHER|||||||0.0032|||||||ANCOVA|ANCOVA model with terms of treatment, baseline lesion count, and center||||||0.0032
72466120|NCT01936324|144455352|OTHER|||||||0.007|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by study center||||||0.0070
72466121|NCT00702650|144455353|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||One-Sample Binomial (Wald) test, 2-sided|||||||<0.001
72466122|NCT00702650|144455358|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||P-value is for Sexual Desire based on a two-sided, paired t-test comparing the Baseline and the Day 120 scores.|t-test, 2 sided|||||||<0.0001
72466123|NCT00702650|144455358|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||P-value is for Overall Sexual Activity Score based on a two-sided, paired t-test comparing the Baseline and the Day 120 scores.|t-test, 2 sided|||||||<0.0001
72564340|NCT02462486|144660431|NON_INFERIORITY|For hypothesis testing, if the lower limit of the 95.1% confidence interval for the difference between an abicipar group and ranibizumab is greater than or equal to -10%, non-inferiority of abicipar group is established.|Percentage Difference|-1.2|||||TWO_SIDED|95.0|-5.0|2.4|||||The 95.1% CI for the weighted difference were calculated based on the Newcombe method using the Cochran-Mantel-Haenszel weights and baseline BCVA (≤55 vs \>55 letters) as stratification factor.|||2.4|-5.0|
72564341|NCT02462486|144660431|NON_INFERIORITY|For hypothesis testing, if the lower limit of the 95.1% confidence interval for the difference between an abicipar group and ranibizumab is greater than or equal to -10%, non-inferiority of abicipar group is established.|Percentage Difference|-4.6|||||TWO_SIDED|95.0|-9.0|-0.5|||||The 95.1% CI for the weighted difference were calculated based on the Newcombe method using the Cochran-Mantel-Haenszel weights and baseline BCVA (≤55 vs \>55 letters) as stratification factor.|||-0.5|-9.0|
72564342|NCT02462486|144660432|NON_INFERIORITY|For hypothesis testing, non-inferiority of abicipar is established if the lower limit of the CI is \> - 5.0 letters.|Least Squares Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|1.1|||TWO_SIDED|95.1|-2.4|2.0|||||MMRM included treatment, region, BL BCVA, BL CRT ≤400 or \>400, choroidal neovascularization lesion type, visit, visit-by-BL BCVA interaction, and treatment-by-visit interaction term as covariates using an unstructured covariance matrix.|||2.0|-2.4|
72564343|NCT02462486|144660432|NON_INFERIORITY|For hypothesis testing, non-inferiority of abicipar is established if the lower limit of the CI is \> - 5.0 letters.|Least Squares Mean Difference|-1.6|STANDARD_ERROR_OF_MEAN|1.1|||TWO_SIDED|95.1|-3.8|0.6|||||MMRM included treatment, region, BL BCVA, BL CRT ≤400 or \>400, choroidal neovascularization lesion type, visit, visit-by-BL BCVA interaction, and treatment-by-visit interaction term as covariates using an unstructured covariance matrix.|||0.6|-3.8|
72564344|NCT02462486|144660433|SUPERIORITY|Superiority of abicipar was demonstrated if the lower limit of CI for the treatment difference was greater than zero.|Least Squares Mean Difference|3.5|STANDARD_ERROR_OF_MEAN|5.4|||TWO_SIDED|95.1|-7.1|14.0|||||MMRM included treatment, region, BL BCVA, BL CRT, choroidal neovascularization lesion type, visit, visit-by-baseline CRT interaction, and treatment-by-visit interaction term as covariates using an unstructured covariance matrix.|||14.0|-7.1|
72564345|NCT02462486|144660433|SUPERIORITY|Superiority of abicipar was demonstrated if the lower limit of CI for the treatment difference was greater than zero.|Least Squares Mean Difference|5.9|STANDARD_ERROR_OF_MEAN|5.4|||TWO_SIDED|95.1|-4.7|16.5|||||MMRM included treatment, region, BL BCVA, BL CRT, choroidal neovascularization lesion type, visit, visit-by-baseline CRT interaction, and treatment-by-visit interaction term as covariates using an unstructured covariance matrix.|||16.5|-4.7|
72564346|NCT02462486|144660434|SUPERIORITY||Percentage Difference|1.4|||||TWO_SIDED|95.0|-5.5|8.4|||||The 95.1% CI for the weighted difference were calculated based on the Newcombe method using the Cochran-Mantel-Haenszel weights and baseline BCVA (≤55 vs \>55 letters) as the stratification factor.|||8.4|-5.5|
72564347|NCT02462486|144660434|SUPERIORITY||Percentage Difference|-2.3|||||TWO_SIDED|95.0|-9.1|4.5|||||The 95.1% CI for the weighted difference were calculated based on the Newcombe method using the Cochran-Mantel-Haenszel weights and baseline BCVA (≤55 vs \>55 letters) as the stratification factor.|||4.5|-9.1|
72370683|NCT00488683|144251642|SUPERIORITY_OR_OTHER||R-square|0.94||||||95.0|||||Regression, Linear|||Linear regression coefficient between demographic factors, memory B cells one month after primary vaccination and hSBA titers at 12 months of age for the serogroup Y||||
72394431|NCT01753856|144295750|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||IC.|ANCOVA|ANCOVA model with treatment group as the main effect and baseline as a covariate.||||||<0.001
72564348|NCT02462486|144660435|SUPERIORITY|Superiority of abicipar was demonstrated if the lower limit of CI for the treatment difference was greater than zero.|Least Squares Mean Difference|-1.6|STANDARD_ERROR_OF_MEAN|1.0|||TWO_SIDED|95.1|-3.5|0.3|||||MMRM included treatment group, region, baseline BCVA in the study eye, baseline VFQ score, visit, and treatment by visit interaction as fixed covariates using an unstructured covariance matrix.|||0.3|-3.5|
72564349|NCT02462486|144660435|SUPERIORITY|Superiority of abicipar was demonstrated if the lower limit of CI for the treatment difference was greater than zero.|Least Squares Mean Difference|-2.0|STANDARD_ERROR_OF_MEAN|1.0|||TWO_SIDED|95.1|-3.9|-0.1|||||MMRM included treatment group, region, baseline BCVA in the study eye, baseline VFQ score, visit, and treatment by visit interaction as fixed covariates using an unstructured covariance matrix.|||-0.1|-3.9|
72564350|NCT01439724|144660445|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.158||||0.05|TWO_SIDED|95.0|0.05|0.498|||Chi-squared|||The primary end point of the study was the incidence of grade 3-4 oral mucositis (OM) according to the WHO scale. Assuming an α =0.05 and a β = 0.20, with the estimates of proportion being 0.40 for placebo (P0) and 0.15 for LLLT (P1) a total of 94 patients were evaluated. One-sided test error was the basis for the sample size determination and all the reported P-values were derived from two-sided statistical tests. P-values less than or equal to 0.05 were considered statistically significant.||0.498|0.050|0.05
72564351|NCT02310763|144660465|SUPERIORITY||Mean Difference (Net)|1.293|STANDARD_ERROR_OF_MEAN|1.022||0.2088|TWO_SIDED|95.0|-0.7343|3.32||The significance level is 0.05.|ANCOVA||Least square mean difference was calculated by placebo minus domagrozumab.|||3.3200|-0.7343|0.2088
72564352|NCT02310763|144660469|SUPERIORITY||Mean Difference (Net)|-0.0845||||0.9191|TWO_SIDED|95.0|-1.7354|1.5663||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Week 17||1.5663|-1.7354|0.9191
72564353|NCT02310763|144660469|SUPERIORITY||Mean Difference (Net)|0.5837||||0.7642|TWO_SIDED|95.0|-3.2978|4.4652||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Week 33||4.4652|-3.2978|0.7642
72466124|NCT00702650|144455358|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||P-value is for Erection Maintained for Satisfactory Duration based on a two-sided, paired t-test comparing the Baseline and the Day 120 scores.|t-test, 2 sided|||||||<0.0001
72466125|NCT00702650|144455358|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||P-value is for Positive Mood based on a two-sided, paired t-test comparing the Baseline and the Day 120 scores.|t-test, 2 sided|||||||<0.0001
72503124|NCT01877655|144536812|SUPERIORITY||Odds Ratio (OR)|1.05||||0.802|TWO_SIDED|95.0|0.73|1.51||P value based on CMH general association test stratified by donor-recipient relatedness and donor CMV serostatus.|Cochran-Mantel-Haenszel||Odds ratio (ASP0113 vs placebo) and 95% CI based on CMH general association test stratified by donor recipient relatedness and donor CMV serostatus.|Analysis of composite of CMV viremia and adjudicated CMV-AVT. The CMV viremia was defined by the protocol as CMV plasma viral load ≥ 1000 IU/mL as assessed by the central laboratory. CMV-specific AVT was determined by the adjudication committee. Participants with no posttransplant viral load data were excluded from the analysis.||1.51|0.73|0.802
72503125|NCT01877655|144536813|SUPERIORITY||Hazard Ratio (HR)|1.01||||0.928|TWO_SIDED|95.0|0.8|1.28||P value based on cox proportional hazards model parameter estimate for the treatment effect.|Cox Proportional Hazards Model|Parameter estimate from cox proportional hazard model (ASP0113 v placebo) with treatment \& randomization strata adjusted for death as a competing risk||Analysis of rate of adjudicated CMV AVT or CMV EOD. Time to first CMV-specific AVT was defined as time to the start of AVT for CMV viremia or CMV EOD. CMV-specific AVT and EOD and were determined by the adjudication committee. Rate based on cumulative incidence function estimate at 1 year.||1.28|0.80|0.928
72503126|NCT01877655|144536814|SUPERIORITY||Odds Ratio (OR)|1.18||||0.393|TWO_SIDED|95.0|0.81|1.73||P value based on cox proportional hazards model parameter estimate for the treatment effect.|Cox Proportional Hazards Model||Odds ratio (ASP0113 vs placebo) and 95% CI based on CMH general association test stratified by donor-recipient relatedness and donor CMV serostatus.|Analysis of all-cause mortality at 1 year. Participants with unknown survival status at 1 year were considered dead for this analysis.||1.73|0.81|0.393
72564354|NCT02310763|144660469|SUPERIORITY||Mean Difference (Net)|0.2712||||0.9423|TWO_SIDED|95.0|-7.3799|7.9223||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Week 49||7.9223|-7.3799|0.9423
72564355|NCT02310763|144660470|SUPERIORITY||Mean Difference (Net)|0.0||||0.9993|TWO_SIDED|95.0|-0.0693|0.0693||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Week 17||0.0693|-0.0693|0.9993
72564356|NCT02310763|144660470|SUPERIORITY||Mean Difference (Net)|-0.0259||||0.5464|TWO_SIDED|95.0|-0.1107|0.0589||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Week 33||0.0589|-0.1107|0.5464
72564357|NCT02310763|144660470|SUPERIORITY||Mean Difference (Net)|-0.042||||0.3041|TWO_SIDED|95.0|-0.1227|0.0386||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Week 49||0.0386|-0.1227|0.3041
72564358|NCT02310763|144660471|SUPERIORITY||Mean Difference (Net)|0.8||||0.3522|TWO_SIDED|95.0|-0.9|2.5||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Week 17||2.5|-0.9|0.3522
72564359|NCT02310763|144660471|SUPERIORITY||Mean Difference (Net)|2.5||||0.0061|TWO_SIDED|95.0|0.7|4.2||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Week 33||4.2|0.7|0.0061
72564360|NCT02310763|144660471|SUPERIORITY|Week 49|Mean Difference (Net)|1.6||||0.1268|TWO_SIDED|95.0|-0.5|3.8||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|||3.8|-0.5|0.1268
72621539|NCT02732145|144773199|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Hymenal Remnants versus Vestibule in patients with normal vulva and positive AWR?||||||0.022|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Hymenal Remnants versus Vestibule in patients with normal vulva and positive AWR.||||0.0220
72564361|NCT02310763|144660472|SUPERIORITY||Mean Difference (Net)|-0.4||||0.7337|TWO_SIDED|95.0|-2.9|2.1||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Left ankle, Week 17||2.1|-2.9|0.7337
72564362|NCT02310763|144660472|SUPERIORITY||Mean Difference (Net)|0.2||||0.8893|TWO_SIDED|95.0|-2.4|2.7||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Left ankle, Week 33||2.7|-2.4|0.8893
72564363|NCT02310763|144660472|SUPERIORITY||Mean Difference (Net)|-1.5||||0.2939|TWO_SIDED|95.0|-4.3|1.3||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Left ankle, Week 49||1.3|-4.3|0.2939
72564364|NCT02310763|144660472|SUPERIORITY||Mean Difference (Net)|0.8||||0.5995|TWO_SIDED|95.0|-2.1|3.6||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Right ankle, Week 17||3.6|-2.1|0.5995
72564365|NCT02310763|144660472|SUPERIORITY||Mean Difference (Net)|2.9||||0.0385|TWO_SIDED|95.0|0.2|5.6||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Right ankle, Week 33||5.6|0.2|0.0385
72564366|NCT02310763|144660472|SUPERIORITY||Mean Difference (Net)|0.0||||0.9927|TWO_SIDED|95.0|-3.3|3.2||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Right ankle, Week 49||3.2|-3.3|0.9927
72564367|NCT02310763|144660473|SUPERIORITY||Mean Difference (Net)|-0.3||||0.6049|TWO_SIDED|95.0|-1.7|1.0||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Week 17||1.0|-1.7|0.6049
72621540|NCT02732145|144773199|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Bartholin's Gland Opening versus Vestibule in patients with normal vulva and positive AWR?||||||0.0078|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Bartholin's Gland Opening versus Vestibule in patients with normal vulva and positive AWR.||||0.0078
72621541|NCT02732145|144773200|EQUIVALENCE|Question: Is there a difference in the incidence of hyperkeratosis in vulvar specimens of patients from different groups?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of the histopathological finding of hyperkeratosis in vulvar specimens of patients from different groups.||||0.0000
72564368|NCT02310763|144660473|SUPERIORITY||Mean Difference (Net)|1.7||||0.2065|TWO_SIDED|95.0|-1.0|4.4||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Week 33||4.4|-1.0|0.2065
72564369|NCT02310763|144660473|SUPERIORITY||Mean Difference (Net)|0.0||||0.9391|TWO_SIDED|95.0|-1.3|1.2||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Week 49||1.2|-1.3|0.9391
72503127|NCT02332915|144536815|SUPERIORITY|||||||0.0128|||||||t-test, 2 sided|dependent t-test||Null hypothesis is that there is no difference in mean effect size values for 2-week follow-up values for treated items for SPT-Intense and SPT-Traditional. The test was performed with a significance level of 0.05 (two-sided).||||.0128
72503128|NCT02332915|144536816|SUPERIORITY|||||||0.942|||||||t-test, 2 sided|dependent t-test||Null hypothesis is that there is no difference in mean effect size values for 2-week follow-up values for untreated (generalization) items for SPT-Intense and SPT-Traditional. The test was performed with a significance level of 0.05 (two-sided).||||.942
72503129|NCT02332915|144536817|OTHER||||||<|0.001|||||||t-test, 2 sided|||Null Hypothesis: No difference in pre-treatment and post-treatment intelligibility scores||||<.001
72503130|NCT05635838|144536836|SUPERIORITY|Response Variable = Treatment + Baseline AN Count Category (≥3 to 4, ≥5 to 10) + Visit + Treatment\*Visit|least squares mean difference|-1.2|STANDARD_ERROR_OF_MEAN|0.506||0.0215|TWO_SIDED|95.0|-2.21|-0.18|||ANCOVA|||||-0.18|-2.21|0.0215
72503131|NCT05635838|144536838|SUPERIORITY|Response Variable = Treatment + Baseline AN Count Category (≥3 to 4, ≥5 to 10) + Visit + Treatment\*Visit|least squares mean difference|-0.68|STANDARD_ERROR_OF_MEAN|0.485||0.1671|TWO_SIDED|95.0|-1.65|0.29|||ANCOVA|||||0.29|-1.65|0.1671
72503132|NCT05635838|144536839|SUPERIORITY|Response Variable = Treatment + Baseline AN Count Category (≥3 to 4, ≥5 to 10) + Visit + Treatment\*Visit|least squares mean difference|0.19|STANDARD_ERROR_OF_MEAN|0.728||0.7982|TWO_SIDED|95.0|-1.27|1.64|||ANCOVA|||||1.64|-1.27|0.7982
72503133|NCT05635838|144536840|SUPERIORITY|Response Variable = Treatment + Baseline AN Count Category (≥3 to 4, ≥5 to 10) + Visit + Treatment\*Visit|least squares mean difference|0.94|STANDARD_ERROR_OF_MEAN|0.73||0.2031|TWO_SIDED|95.0|-0.52|2.4|||ANCOVA|||||2.40|-0.52|0.2031
72503134|NCT05635838|144536842|SUPERIORITY|Response Variable = Treatment + Baseline AN Count Category (≥3 to 4, ≥5 to 10) + Visit + Treatment\*Visit|least squares mean difference|-0.82|STANDARD_ERROR_OF_MEAN|0.683||0.2387|TWO_SIDED|95.0|-2.2|0.56|||ANCOVA|||||0.56|-2.20|0.2387
72503135|NCT02128490|144536876|SUPERIORITY_OR_OTHER||Difference in Proportions|35.9|||<|0.001|TWO_SIDED|95.0|20.8|51.0|||Fisher Exact|||||51.0|20.8|<0.001
72503136|NCT02128490|144536876|SUPERIORITY_OR_OTHER||Difference in Proportions|44.7|||<|0.001|TWO_SIDED|95.0|28.9|60.5|||Fisher Exact|||||60.5|28.9|<0.001
72621542|NCT02732145|144773200|EQUIVALENCE|Question: Is there a difference in the incidence of parakeratosis in vulvar specimens of patients from different groups?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of the histopathological finding of parakeratosis in vulvar specimens of patients from different groups.||||0.0000
72503137|NCT02128490|144536876|SUPERIORITY_OR_OTHER||Difference in Proportions|22.4||||0.034|TWO_SIDED|95.0|3.7|41.0|||Fisher Exact|||||41.0|3.7|0.034
72503138|NCT02128490|144536876|SUPERIORITY_OR_OTHER||Difference in Proportions|4.2||||0.817|TWO_SIDED|95.0|-18.2|26.6|||Fisher Exact|||||26.6|-18.2|0.817
72503139|NCT02128490|144536877|SUPERIORITY_OR_OTHER||Difference in Proportions|12.6||||0.224|TWO_SIDED|95.0|-3.9|29.0|||Fisher Exact|||||29.0|-3.9|0.224
72503140|NCT02128490|144536877|SUPERIORITY_OR_OTHER||Difference in Proportions|31.6||||0.004|TWO_SIDED|95.0|13.1|50.1|||Fisher Exact|||||50.1|13.1|0.004
72621543|NCT02732145|144773200|EQUIVALENCE|Question: Is there a difference in the incidence of acanthosis in vulvar specimens of patients from different groups?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of the histopathological finding of acanthosis in vulvar specimens of patients from different groups.||||0.0000
72621544|NCT02732145|144773200|EQUIVALENCE|Question: Is there a difference in the incidence of epidermal atrophy in vulvar specimens of patients from different groups?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of the histopathological finding of epidermal atrophy in vulvar specimens of patients from different groups.||||0.0000
72621545|NCT02732145|144773200|EQUIVALENCE|Question: Is there a difference in the incidence of inflammatory infiltrates in vulvar specimens of patients from different groups?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of the histopathological finding of inflammatory infiltrates in vulvar specimens of patients from different groups.||||0.0000
72621546|NCT02732145|144773200|EQUIVALENCE|Question: Is there a difference in the incidence of mononuclear inflammatory infiltrates in vulvar specimens of patients from different groups?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of the histopathological finding of mononuclear inflammatory infiltrates in vulvar specimens of patients from different groups.||||0.0000
72621547|NCT02732145|144773200|EQUIVALENCE|Question: Is there a difference in the incidence of lymphocytes in vulvar specimens of patients from different groups?||||||0.0105|||||||Chi-squared|||Parameter: The difference in the incidence of the histopathological finding of lymphocytes (infiltrates) in vulvar specimens of patients from different groups.||||0.0105
72621548|NCT02732145|144773200|EQUIVALENCE|Question: Is there a difference in the incidence of mastocytes in vulvar specimens of patients from different groups?||||||0.0064|||||||Chi-squared|||Parameter: The difference in the incidence of the histopathological finding of mastocytes in vulvar specimens of patients from different groups.||||0.0064
72621549|NCT02732145|144773200|EQUIVALENCE|Question: Is there a difference in the incidence of collagen fibers in vulvar specimens of patients from different groups?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of the histopathological finding of collagen fibers in vulvar specimens of patients from different groups.||||0.0000
72621550|NCT02732145|144773200|EQUIVALENCE|Question: Is there a difference in the incidence of hyalinization in vulvar specimens of patients from different groups?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of the histopathological finding of hyalinization in vulvar specimens of patients from different groups.||||0.0000
72621551|NCT02732145|144773200|EQUIVALENCE|Question: Is there a difference in the incidence of hyperpigmentation in vulvar specimens of patients from different groups?||||||0.0342|||||||Chi-squared|||Parameter: The difference in the incidence of the histopathological finding of hyperpigmentation in vulvar specimens of patients from different groups.||||0.0342
72621552|NCT02732145|144773200|EQUIVALENCE|Question: Is there a difference in the incidence of elongated dermal papillae in vulvar specimens of patients from different groups?||||||0.0148|||||||Chi-squared|||Parameter: The difference in the incidence of the histopathological finding of elongated dermal papillae in vulvar specimens of patients from different groups.||||0.0148
72564370|NCT02310763|144660474|SUPERIORITY||Mean Difference (Net)|1.8||||0.8499|TWO_SIDED|95.0|-16.7|20.3||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Week 17||20.3|-16.7|0.8499
72564371|NCT02310763|144660474|SUPERIORITY||Mean Difference (Net)|8.9||||0.4008|TWO_SIDED|95.0|-12.0|29.8||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Week 33||29.8|-12.0|0.4008
72564372|NCT02310763|144660474|SUPERIORITY||Mean Difference (Net)|-1.5||||0.916|TWO_SIDED|95.0|-30.0|27.0||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Week 49||27.0|-30.0|0.9160
72564373|NCT02310763|144660475|SUPERIORITY||Mean Difference (Net)|0.115||||0.5726|TWO_SIDED|95.0|-0.287|0.517||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Left elbow extension, Week 17||0.517|-0.287|0.5726
72564374|NCT02310763|144660475|SUPERIORITY||Mean Difference (Net)|-0.163||||0.4334|TWO_SIDED|95.0|-0.574|0.248||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Left elbow extension, Week 33||0.248|-0.574|0.4334
72564375|NCT02310763|144660475|SUPERIORITY||Mean Difference (Net)|-0.126||||0.5767|TWO_SIDED|95.0|-0.573|0.321||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Left elbow extension, Week 49||0.321|-0.573|0.5767
72564376|NCT02310763|144660475|SUPERIORITY||Mean Difference (Net)|-0.022||||0.9274|TWO_SIDED|95.0|-0.489|0.446||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Right elbow extension, Week 17||0.446|-0.489|0.9274
72564377|NCT02310763|144660475|SUPERIORITY||Mean Difference (Net)|-0.439||||0.0469|TWO_SIDED|95.0|-0.872|-0.006||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Right elbow extension, Week 33||-0.006|-0.872|0.0469
72564378|NCT02310763|144660475|SUPERIORITY||Mean Difference (Net)|-0.166||||0.4362|TWO_SIDED|95.0|-0.587|0.255||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Right elbow extension, Week 49||0.255|-0.587|0.4362
72564379|NCT02310763|144660476|SUPERIORITY||Mean Difference (Net)|-0.156||||0.5557|TWO_SIDED|95.0|-0.679|0.367||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Left elbow flexion, Week 17||0.367|-0.679|0.5557
72564380|NCT02310763|144660476|SUPERIORITY||Mean Difference (Net)|-0.303||||0.2669|TWO_SIDED|95.0|-0.841|0.235||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Left elbow flexion, Week 33||0.235|-0.841|0.2669
72564381|NCT02310763|144660476|SUPERIORITY||Mean Difference (Net)|-0.161||||0.4665|TWO_SIDED|95.0|-0.598|0.276||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Left elbow flexion, Week 49||0.276|-0.598|0.4665
72564382|NCT02310763|144660476|SUPERIORITY||Mean Difference (Net)|-0.083||||0.7335|TWO_SIDED|95.0|-0.564|0.399||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Right elbow flexion, Week 17||0.399|-0.564|0.7335
72564383|NCT02310763|144660476|SUPERIORITY||Mean Difference (Net)|-0.361||||0.1695|TWO_SIDED|95.0|-0.877|0.156||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Right elbow flexion, Week 33||0.156|-0.877|0.1695
72564384|NCT02310763|144660476|SUPERIORITY||Mean Difference (Net)|-0.189||||0.3783|TWO_SIDED|95.0|-0.612|0.234||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Right elbow flexion, Week 49||0.234|-0.612|0.3783
72564385|NCT02310763|144660477|SUPERIORITY||Mean Difference (Net)|-0.586||||0.1078|TWO_SIDED|95.0|-1.303|0.13||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Left hip abduction, Week 17||0.130|-1.303|0.1078
72564386|NCT02310763|144660477|SUPERIORITY||Mean Difference (Net)|0.046||||0.8967|TWO_SIDED|95.0|-0.654|0.746||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Left hip abduction, Week 33||0.746|-0.654|0.8967
72564387|NCT02310763|144660477|SUPERIORITY||Mean Difference (Net)|-0.378||||0.3196|TWO_SIDED|95.0|-1.128|0.371||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Left hip abduction, Week 49||0.371|-1.128|0.3196
72564388|NCT02310763|144660477|SUPERIORITY||Mean Difference (Net)|-0.689||||0.0526|TWO_SIDED|95.0|-1.386|0.008||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Right hip abduction, Week 17||0.008|-1.386|0.0526
72564389|NCT02310763|144660477|SUPERIORITY||Mean Difference (Net)|-0.336||||0.3739|TWO_SIDED|95.0|-1.082|0.41||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Right hip abduction, Week 33||0.410|-1.082|0.3739
72564390|NCT02310763|144660477|SUPERIORITY||Mean Difference (Net)|-0.322||||0.4019|TWO_SIDED|95.0|-1.079|0.436||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Right hip abduction, Week 49||0.436|-1.079|0.4019
72564391|NCT02310763|144660478|SUPERIORITY||Mean Difference (Net)|-0.107||||0.7676|TWO_SIDED|95.0|-0.825|0.61||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Left knee extension, Week 17||0.610|-0.825|0.7676
72564392|NCT02310763|144660478|SUPERIORITY||Mean Difference (Net)|-0.322||||0.4127|TWO_SIDED|95.0|-1.098|0.454||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Left knee extension, Week 33||0.454|-1.098|0.4127
72564393|NCT02310763|144660478|SUPERIORITY||Mean Difference (Net)|0.113||||0.7815|TWO_SIDED|95.0|-0.693|0.919||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Left knee extension, Week 49||0.919|-0.693|0.7815
72503141|NCT02128490|144536877|SUPERIORITY_OR_OTHER||Difference in Proportions|-17.5||||0.139|TWO_SIDED|95.0|-38.1|3.2|||Fisher Exact|||||3.2|-38.1|0.139
72503142|NCT02128490|144536877|SUPERIORITY_OR_OTHER||Difference in Proportions|4.3||||0.815|TWO_SIDED|95.0|-17.9|26.4|||Fisher Exact|||||26.4|-17.9|0.815
72503143|NCT02128490|144536878|SUPERIORITY_OR_OTHER||Difference in Proportions|53.8|||<|0.001|TWO_SIDED|95.0|38.2|69.5|||Fisher Exact|||||69.5|38.2|<0.001
72503144|NCT02128490|144536878|SUPERIORITY_OR_OTHER||Difference in Proportions|55.3|||<|0.001|TWO_SIDED|95.0|39.5|71.1|||Fisher Exact|||||71.1|39.5|<0.001
72503145|NCT02128490|144536878|SUPERIORITY_OR_OTHER||Difference in Proportions|21.4||||0.069|TWO_SIDED|95.0|-0.3|43.1|||Fisher Exact|||||43.1|-0.3|0.069
72503146|NCT02128490|144536878|SUPERIORITY_OR_OTHER||Difference in Proportions|-4.2||||0.817|TWO_SIDED|95.0|-26.6|18.2|||Fisher Exact|||||18.2|-26.6|0.817
72503147|NCT02243176|144536879|NON_INFERIORITY_OR_EQUIVALENCE|With a total sample size of 480 patients randomized and an expected drop-out rate of 20%, the trial will be powered at 90% to establish non-inferiority for the primary endpoint, at a one-sided alpha level of 0.025, with the non-inferiority margin of 0.4%, assuming the true effects are the same between treatments. The calculation is also based on the assumption that the standard deviation for the change in HbA1c is 1.2%.|Mean Difference (Final Values)|-0.04|STANDARD_ERROR_OF_MEAN|0.09||0.6236|TWO_SIDED|95.0|-0.22|0.13||This p value is for the hypothesis of superiority|Mixed Model Repeated Measures||Mean difference=Saxagliptin - Acarbose|"H01: μS-μA≥ 0.4% vs Ha1: μS-μA\< 0.4%. Null hypothesis will be rejected if the upper limit of 2-sided 95% CI is below 0.4%.If the null hypothesis above (H01) is rejected, the following hypothesis will be tested to further establish superiority:~H02: μS-μA≥ 0 vs Ha2: μS-μA\< 0. This null hypothesis (H02) will be rejected if the upper limit of 2-sided 95% CI is below 0."||0.13|-0.22|0.6236
72564394|NCT02310763|144660478|SUPERIORITY||Mean Difference (Net)|-0.236||||0.4975|TWO_SIDED|95.0|-0.924|0.451||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Right knee extension, Week 17||0.451|-0.924|0.4975
72394432|NCT01753856|144295750|SUPERIORITY_OR_OTHER|||||||0.85|TWO_SIDED|||||PC.|ANCOVA|ANCOVA model with treatment group as the main effect and baseline as a covariate.||||||0.850
72564395|NCT02310763|144660478|SUPERIORITY||Mean Difference (Net)|-0.467||||0.2646|TWO_SIDED|95.0|-1.294|0.359||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Right knee extension, Week 33||0.359|-1.294|0.2646
72564396|NCT02310763|144660478|SUPERIORITY||Mean Difference (Net)|-0.149||||0.732|TWO_SIDED|95.0|-1.008|0.71||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Right knee extension, Week 49||0.710|-1.008|0.7320
72503148|NCT02243176|144536880|NON_INFERIORITY_OR_EQUIVALENCE|With a total sample size of 480 patients randomized and an expected drop-out rate of 20%, the trial will be powered at 90% to establish non-inferiority for the primary endpoint, at a one-sided alpha level of 0.025, with the non-inferiority margin of 0.4%, assuming the true effects are the same between treatments. The calculation is also based on the assumption that the standard deviation for the change in HbA1c is 1.2%.|Mean Difference (Final Values)|-0.03|STANDARD_ERROR_OF_MEAN|0.09||0.7809|TWO_SIDED|95.0|-0.21|0.15||This p value is for the hypothesis of superiority|Mixed Model Repeated Measures||Mean difference=Saxagliptin - Acarbose|"H01: μS-μA≥ 0.4% vs Ha1: μS-μA\< 0.4%. Null hypothesis will be rejected if the upper limit of 2-sided 95% CI is below 0.4%.If the null hypothesis above (H01) is rejected, the following hypothesis will be tested to further establish superiority:~H02: μS-μA≥ 0 vs Ha2: μS-μA\< 0. This null hypothesis (H02) will be rejected if the upper limit of 2-sided 95% CI is below 0."||0.15|-0.21|0.7809
72564397|NCT02310763|144660479|SUPERIORITY||Mean Difference (Net)|-0.044||||0.8569|TWO_SIDED|95.0|-0.525|0.437||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Left shoulder abduction, Week 17||0.437|-0.525|0.8569
72564398|NCT02310763|144660479|SUPERIORITY||Mean Difference (Net)|-0.154||||0.5495|TWO_SIDED|95.0|-0.663|0.355||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Left shoulder abduction, Week 33||0.355|-0.663|0.5495
72564399|NCT02310763|144660479|SUPERIORITY||Mean Difference (Net)|-0.023||||0.934|TWO_SIDED|95.0|-0.566|0.521||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Left shoulder abduction, Week 49||0.521|-0.566|0.9340
72621553|NCT02732145|144773200|EQUIVALENCE|Question: Is there a difference in the incidence of blood vessels in vulvar specimens of patients from different groups?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of the histopathological finding of blood vessels in vulvar specimens of patients from different groups.||||0.0000
72621554|NCT02732145|144773200|EQUIVALENCE|Question: Is there a difference in the incidence of sebaceous glands in vulvar specimens of patients from different groups?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of the histopathological finding of sebaceous glands in vulvar specimens of patients from different groups.||||0.0000
72621555|NCT02732145|144773200|EQUIVALENCE|Question: Is there a difference in the incidence of nerve fibers in vulvar specimens of patients from different groups?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of the histopathological finding of nerve fibers in vulvar specimens of patients from different groups.||||0.0000
72503149|NCT02243176|144536881|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.22|||<|0.0001|TWO_SIDED|95.0|0.12|0.39|||Cochran-Mantel-Haenszel|Stratefied by the baseline disease severity (HbA1c \< 8.0% and ≥ 8.0%)|RR = Saxagliptin/Acarbose|||0.39|0.12|<0.0001
72503150|NCT02243176|144536882|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.92||||0.5044|TWO_SIDED|95.0|0.74|1.15|||Cochran-Mantel-Haenszel|stratefied by baseline disease severity (HbA1c\<8%, \>=8%)||||1.15|0.74|0.5044
72564400|NCT02310763|144660479|SUPERIORITY||Mean Difference (Net)|-0.236||||0.3279|TWO_SIDED|95.0|-0.711|0.239||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Right shoulder abduction, Week 17||0.239|-0.711|0.3279
72564401|NCT02310763|144660479|SUPERIORITY||Mean Difference (Net)|-0.757||||0.0086|TWO_SIDED|95.0|-1.318|-0.196||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Right shoulder abduction, Week 33||-0.196|-1.318|0.0086
72394433|NCT01753856|144295751|SUPERIORITY_OR_OTHER|||||||0.004|TWO_SIDED|||||DL Only, in CC.|ANCOVA|ANCOVA model with treatment group as the main effect and baseline as a covariate.||||||0.004
72394434|NCT01753856|144295751|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||DL and Imputed SL, in the CC.|ANCOVA|ANCOVA model with treatment group as the main effect and baseline as a covariate.||||||<0.001
72394435|NCT01753856|144295751|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||DL Only, in EC.|ANCOVA|ANCOVA model with treatment group as the main effect and baseline as a covariate.||||||<0.001
72621556|NCT02732145|144773201|SUPERIORITY|Question: Is there a difference in the incidence of vulvar complaints depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvar dermatosis?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of vulvar complaints depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvar dermatosis.||||0.0000
72621557|NCT02732145|144773201|SUPERIORITY|Question: Is there a difference in the incidence of symptoms of the dull pain of the vulva on the histopathology of the epidermis (normal versus abnormal) in patients with vulvar dermatosis?||||||1|||||||Chi-squared|||Parameter: The difference in the incidence of symptoms of the dull (slow) pain of the vulva (burning, stinging, soreness, irritation, itching, inflammation, aching) depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvar dermatosis.||||1.0000
72621558|NCT02732145|144773201|SUPERIORITY|Question: Is there a difference in the incidence of vulvar burning depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvar dermatosis?||||||0.3533|||||||Chi-squared|||Parameter: The incidence of vulvar burning depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvar dermatosis.||||0.3533
72564402|NCT02310763|144660479|SUPERIORITY||Mean Difference (Net)|-0.439||||0.2328|TWO_SIDED|95.0|-1.165|0.286||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Right shoulder abduction, Week 49||0.286|-1.165|0.2328
72394436|NCT01753856|144295751|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||DL and Imputed SL, in EC.|ANCOVA|ANCOVA model with treatment group as the main effect and baseline as a covariate.||||||<0.001
72564403|NCT02310763|144660480|EQUIVALENCE|The comparator was the natural history control group. The significance level is 0.05.|Mean Difference (Net)|0.211||||0.8908|TWO_SIDED|95.0|-2.8353|3.2573|||Mixed Models Analysis||Mean difference was calculated by Sequence 3 minus natural history control group.|||3.2573|-2.8353|0.8908
72621559|NCT02732145|144773201|SUPERIORITY|Question: Is there a difference in the incidence of vulvar stinging depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvar dermatosis?||||||0.5641|||||||Chi-squared|||Parameter: The incidence of vulvar stinging depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvar dermatosis.||||0.5641
72621560|NCT02732145|144773201|SUPERIORITY|Question: Is there a difference in the incidence of vulvar soreness depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvar dermatosis?||||||0.9684|||||||Chi-squared|||Parameter: The incidence of vulvar soreness depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvar dermatosis.||||0.9684
72621561|NCT02732145|144773201|SUPERIORITY|Question: Is there a difference in the incidence of vulvar irritation depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvar dermatosis?||||||0.8599|||||||Chi-squared|||Parameter: The incidence of vulvar irritation depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvar dermatosis.||||0.8599
72621562|NCT02732145|144773201|SUPERIORITY|Question: Is there a difference in the incidence of vulvar itching depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvar dermatosis?||||||0.9402|||||||Chi-squared|||Parameter: The incidence of vulvar itching depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvar dermatosis.||||0.9402
72621563|NCT02732145|144773201|SUPERIORITY|Question: Is there a difference in the incidence of the feeling of vulvar inflammation depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvar dermatosis?||||||0.8389|||||||Chi-squared|||Parameter: The incidence of the feeling of vulvar inflammation depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvar dermatosis.||||0.8389
72621564|NCT02732145|144773201|SUPERIORITY|Question: Is there a difference in the incidence of vulvar aching depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvar dermatosis?||||||0.7617|||||||Chi-squared|||Parameter: The incidence of vulvar aching depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvar dermatosis.||||0.7617
72621565|NCT02732145|144773201|SUPERIORITY|Question: Is there a difference in the incidence of the sharp pain of the vulva depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvar dermatosis?||||||0.4613|||||||Chi-squared|||Parameter: The difference in the incidence of the sharp (fast) pain of the vulva (knife-like pain, paper-cuts pain, stabbing, sticking) depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvar dermatosis.||||0.4613
72621566|NCT02732145|144773201|SUPERIORITY|Question: Is there a difference in the incidence of vulvar knife-like pain depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvar dermatosis?||||||0.0331|||||||Chi-squared, Corrected|||Parameter: The incidence of the vulvar knife-like pain depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvar dermatosis.||||0.0331
72621567|NCT02732145|144773201|SUPERIORITY|Question: Is there a difference in the incidence of vulvar paper-cuts pain depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvar dermatosis?||||||0.9402|||||||Chi-squared|||Parameter: The incidence of the vulvar paper-cuts pain depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvar dermatosis.||||0.9402
72621568|NCT02732145|144773201|SUPERIORITY|Question: Is there a difference in the incidence of vulvar pain like stabbing depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvar dermatosis?||||||0.9139|||||||Chi-squared|||Parameter: The incidence of vulvar pain like stabbing depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvar dermatosis.||||0.9139
72621569|NCT02732145|144773201|SUPERIORITY|Question: Is there a difference in the incidence of vulvar pain like sticking depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvar dermatosis?||||||0.8925|||||||Chi-squared|||Parameter: The incidence of the vulvar pain like sticking depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvar dermatosis.||||0.8925
72621570|NCT02732145|144773202|SUPERIORITY|Question: Is there a difference in the incidence of vulvar complaints depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvodynia?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of vulvar complaints depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvodynia.||||0.0000
72621571|NCT02732145|144773202|SUPERIORITY|Question: Is there a difference in the incidence of symptoms of the dull pain depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvodynia?||||||0.6921|||||||Chi-squared|||Parameter: The difference in the incidence of symptoms of the dull (slow) pain depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvodynia.||||0.6921
72621572|NCT02732145|144773202|SUPERIORITY|Question: Is there a difference in the incidence of vulvar burning on the histopathology of the epidermis (normal versus abnormal) in patients with vulvodynia?||||||0.1848|||||||Chi-squared|||Parameter: The incidence of vulvar burning depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvodynia.||||0.1848
72564404|NCT02310763|144660481|SUPERIORITY|The comparator was the natural history control group. The significance level is 0.05.|Mean Difference (Net)|0.819||||0.4748|TWO_SIDED|95.0|-1.4514|3.0895|||Mixed Models Analysis||Mean difference was calculated by Sequence 1 minus natural history control group.|||3.0895|-1.4514|0.4748
72621573|NCT02732145|144773202|SUPERIORITY|Question: Is there a difference in the incidence of vulvar stinging depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvodynia?||||||0.9048|||||||Chi-squared|||Parameter: The incidence of vulvar stinging depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvodynia.||||0.9048
72564405|NCT02310763|144660482|EQUIVALENCE|The comparator was the natural history control group. The significance level is 0.05.|Mean Difference (Net)|0.0097||||0.807|TWO_SIDED|95.0|-0.0692|0.0887|||Mixed Models Analysis||Mean difference was calculated by Sequence 3 minus natural history control group.|||0.0887|-0.0692|0.8070
72564406|NCT02310763|144660483|SUPERIORITY|The comparator was the natural history control group. The significance level is 0.05.|Mean Difference (Net)|0.0506||||0.3643|TWO_SIDED|95.0|-0.0594|0.1607|||Mixed Models Analysis||Mean difference was calculated by Sequence 1 minus natural history control group.|||0.1607|-0.0594|0.3643
72564407|NCT02310763|144660484|EQUIVALENCE|The comparator was the natural history control group. The significance level is 0.05.|Mean Difference (Net)|-2.9||||0.0483|TWO_SIDED|95.0|-5.7|0.0|||Mixed Models Analysis||Mean difference was calculated by Sequence 3 minus natural history control group.|||0|-5.7|0.0483
72564408|NCT02310763|144660485|SUPERIORITY|The comparator was the natural history control group. The significance level is 0.05.|Mean Difference (Net)|-3.9||||0.0146|TWO_SIDED|95.0|-7.0|-0.8|||Mixed Models Analysis||Mean difference was calculated by Sequence 1 minus natural history control group.|||-0.8|-7.0|0.0146
72564409|NCT02310763|144660486|EQUIVALENCE|The comparator was the natural history control group. The significance level is 0.05.|Mean Difference (Net)|-31.6||||0.1669|TWO_SIDED|95.0|-76.9|13.6|||Mixed Models Analysis||Mean difference was calculated by Sequence 3 minus natural history control group.|||13.6|-76.9|0.1669
72370684|NCT00488683|144251642|SUPERIORITY_OR_OTHER||R-square|0.85||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between demographic factors, memory B cells one month after primary vaccination and hSBA titers at 12 months of age for the serogroup Y||||
72466126|NCT00702650|144455358|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||P-value is for Negative Mood based on a two-sided, paired t-test comparing the Baseline and the Day 120 scores.|t-test, 2 sided|||||||<0.0001
72466127|NCT00702650|144455359|SUPERIORITY_OR_OTHER|||||||0.0254||95.0||||p-value for Physical Component Score based on a one-sample t-test comparing Day 120 and Baseline values.|t-test, 2 sided|||||||0.0254
72466128|NCT00702650|144455359|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||p-value for Mental Component Score based on a one-sample t-test comparing Day 120 and Baseline values.|t-test, 2 sided|||||||<0.0001
72466129|NCT03954223|144455368|SUPERIORITY|||||||0.4|TWO_SIDED|95.0|||||ANOVA|||||||0.4
72466130|NCT03954223|144455369|SUPERIORITY||Median Difference (Final Values)|-7.0||||0.2|TWO_SIDED|95.0|||||Regression, Linear|Mixed-effects generalized linear model of the glycemic profile change extracted from CGM data.||||||0.2
72466131|NCT01850823|144455370|EQUIVALENCE|Equivalence based on Test/Reference Ratio and 90% confidence interval (as per OGD guidance)|Ratio Test/Reference LS Mean|114.723|||||TWO_SIDED|90.0|99.077|134.286||||||Conducted on Per Protocol Population||134.286|99.077|
72564410|NCT02310763|144660487|SUPERIORITY|The comparator was the natural history control group. The significance level is 0.05.|Mean Difference (Net)|-66.3||||0.0267|TWO_SIDED|95.0|-124.5|-8.1|||Mixed Models Analysis||Mean difference was calculated by Sequence 1 minus natural history control group.|||-8.1|-124.5|0.0267
72564411|NCT02310763|144660488|SUPERIORITY||Mean Difference (Net)|-0.0692||||0.7033|TWO_SIDED|95.0|-0.4345|0.2961||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC\<3.5 seconds||0.2961|-0.4345|0.7033
72466132|NCT01850823|144455371|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||The superiority of treatment over the placebo will be concluded if the treatment's mean change from baseline is statistically significantly greater (p\<0.05, 2-sided) than that of the placebo in the ANCOVA based on the treatment and placebo results. The superiority of Test and Reference treatments over the placebo will be evaluated identically in a separate ANCOVA.||||<0.0001
72466133|NCT01850823|144455371|SUPERIORITY|||||||0.0002|||||||ANCOVA|||The superiority of treatment over the placebo will be concluded if the treatment's mean change from baseline is statistically significantly greater (p\<0.05, 2-sided) than that of the placebo in the ANCOVA based on the treatment and placebo results. The superiority of Test and Reference treatments over the placebo will be evaluated identically in a separate ANCOVA.||||0.0002
72394437|NCT01753856|144295751|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||DL Only, in IC.|ANCOVA|ANCOVA model with treatment group as the main effect and baseline as a covariate.||||||<0.001
72394438|NCT01753856|144295751|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||DL and Imputed SL, in IC.|ANCOVA|ANCOVA model with treatment group as the main effect and baseline as a covariate.||||||<0.001
72394439|NCT01753856|144295751|SUPERIORITY_OR_OTHER|||||||0.931|TWO_SIDED|||||DL Only, in PC.|ANCOVA|ANCOVA model with treatment group as the main effect and baseline as a covariate.||||||0.931
72394440|NCT01753856|144295751|SUPERIORITY_OR_OTHER|||||||0.549|TWO_SIDED|||||DL and Imputed SL, in PC.|ANCOVA|ANCOVA model with treatment group as the main effect and baseline as a covariate.||||||0.549
72394441|NCT01753856|144295752|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||DL Only, in CC.|ANCOVA|ANCOVA model with treatment group as the main effect and baseline as a covariate.||||||<0.001
72394442|NCT01753856|144295752|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||DL and Imputed SL, in CC.|ANCOVA|ANCOVA model with treatment group as the main effect and baseline as a covariate.||||||<0.001
72394443|NCT01753856|144295752|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||DL Only, in EC.|ANCOVA|ANCOVA model with treatment group as the main effect and baseline as a covariate.||||||<0.001
72394444|NCT01753856|144295752|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||DL and Imputed SL, in EC.|ANCOVA|ANCOVA model with treatment group as the main effect and baseline as a covariate.||||||<0.001
72394445|NCT01753856|144295752|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||DL Only, in IC.|ANCOVA|ANCOVA model with treatment group as the main effect and baseline as a covariate.||||||<0.001
72394446|NCT01753856|144295752|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||DL and Imputed SL, in IC.|ANCOVA|ANCOVA model with treatment group as the main effect and baseline as a covariate.||||||<0.001
72394447|NCT01753856|144295752|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||DL Only, in PC.|ANCOVA|ANCOVA model with treatment group as the main effect and baseline as a covariate.||||||<0.001
72394448|NCT01753856|144295752|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||DL and Imputed SL, in PC.|ANCOVA|ANCOVA model with treatment group as the main effect and baseline as a covariate.||||||<0.001
72394449|NCT01753856|144295753|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||sLS/BS, in CC.|ANCOVA|ANCOVA model with treatment group as the main effect and baseline as a covariate.||||||<0.001
72394450|NCT01753856|144295753|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||dLS/BS, in CC.|ANCOVA|ANCOVA model with treatment group as the main effect and baseline as a covariate.||||||<0.001
72564412|NCT02310763|144660488|SUPERIORITY||Mean Difference (Net)|0.2114||||0.6893|TWO_SIDED|95.0|-0.8472|1.27||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC\>=3.5 and \<= 8 seconds||1.27|-0.8472|0.6893
72394451|NCT01753856|144295753|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||sLS/BS, in EC.|ANCOVA|ANCOVA model with treatment group as the main effect and baseline as a covariate.||||||<0.001
72394452|NCT01753856|144295753|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||dLS/BS, in EC.|ANCOVA|ANCOVA model with treatment group as the main effect and baseline as a covariate.||||||<0.001
72394453|NCT01753856|144295753|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||sLS/BS, in IC.|ANCOVA|ANCOVA model with treatment group as the main effect and baseline as a covariate.||||||<0.001
72394454|NCT01753856|144295753|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||dLS/BS, in IC.|ANCOVA|ANCOVA model with treatment group as the main effect and baseline as a covariate.||||||<0.001
72394455|NCT01753856|144295753|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||sLS/BS, in PC.|ANCOVA|ANCOVA model with treatment group as the main effect and baseline as a covariate.||||||<0.001
72394456|NCT01753856|144295753|SUPERIORITY_OR_OTHER|||||||0.028|TWO_SIDED|||||dLS/BS, in PC.|ANCOVA|ANCOVA model with treatment group as the main effect and baseline as a covariate.||||||0.028
72394457|NCT01753856|144295754|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||1 month.|Wilcoxon (Mann-Whitney)|||||||<0.001
72394458|NCT01753856|144295754|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||3 months.|Wilcoxon (Mann-Whitney)|||||||<0.001
72394459|NCT01753856|144295754|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||6 months.|Wilcoxon (Mann-Whitney)|||||||<0.001
72394460|NCT01753856|144295755|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||1 month.|Wilcoxon (Mann-Whitney)|||||||<0.001
72394461|NCT01753856|144295755|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||3 months.|Wilcoxon (Mann-Whitney)|||||||<0.001
72394462|NCT01753856|144295755|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||6 months.|Wilcoxon (Mann-Whitney)|||||||<0.001
72394463|NCT01753856|144295756|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||1 month.|Wilcoxon (Mann-Whitney)|||||||<0.001
72394464|NCT01753856|144295756|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||3 months.|Wilcoxon (Mann-Whitney)|||||||<0.001
72394465|NCT01753856|144295756|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||6 months.|Wilcoxon (Mann-Whitney)|||||||<0.001
72394466|NCT01753856|144295757|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||1 month.|Wilcoxon (Mann-Whitney)|||||||<0.001
72394467|NCT01753856|144295757|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||3 months.|Wilcoxon (Mann-Whitney)|||||||<0.001
72394468|NCT01753856|144295757|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||6 months.|Wilcoxon (Mann-Whitney)|||||||<0.001
72394469|NCT01753856|144295758|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||DL Only, in CC.|Wilcoxon (Mann-Whitney)|||||||<0.001
72394470|NCT01753856|144295758|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||DL and Imputed SL, in CC.|Wilcoxon (Mann-Whitney)|||||||<0.001
72394471|NCT01753856|144295758|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||DL Only, in EC.|Wilcoxon (Mann-Whitney)|||||||<0.001
72394472|NCT01753856|144295758|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||DL and Imputed SL, in EC.|Wilcoxon (Mann-Whitney)|||||||<0.001
72394473|NCT01753856|144295758|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||DL Only, in IC.|Wilcoxon (Mann-Whitney)|||||||<0.001
72394474|NCT01753856|144295758|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||DL and Imputed SL, in IC.|Wilcoxon (Mann-Whitney)|||||||<0.001
72394475|NCT01753856|144295759|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED|||||DL Only, in CC.|Wilcoxon (Mann-Whitney)|||||||0.002
72394476|NCT01753856|144295759|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||DL and Imputed SL, in CC.|Wilcoxon (Mann-Whitney)|||||||<0.001
72394477|NCT01753856|144295759|SUPERIORITY_OR_OTHER|||||||0.214|TWO_SIDED|||||DL Only, in EC.|Wilcoxon (Mann-Whitney)|||||||0.214
72370685|NCT00488683|144251642|SUPERIORITY_OR_OTHER||R-square|0.03||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration at 12 months of age for the serogroup A||||
72466134|NCT01844726|144455385|SUPERIORITY||Mean Difference (Net)|0.05||||0.1|TWO_SIDED||||||t-test, 2 sided|||Change in BOLD signal activation across task derived learning circuit were compared between GLYX-13 and placebo groups using an independent group t-test.||||.10
72466135|NCT01844726|144455386|SUPERIORITY|||||||0.57|||||||t-test, 2 sided|||||||.57
72503151|NCT02243176|144536883|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.28||||0.0518|TWO_SIDED|95.0|0.98|1.67|||Cochran-Mantel-Haenszel|Stratefied by the baseline disease severity (HbA1c \< 8.0% and ≥ 8.0%)|RR = Saxagliptin/Acarbose|||1.67|0.98|0.0518
72564413|NCT02310763|144660488|SUPERIORITY||Mean Difference (Net)|-2.6439||||0.6469|TWO_SIDED|95.0|-14.4292|9.1414||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC\>8 seconds||9.1414|-14.4292|0.6469
72370686|NCT00488683|144251642|SUPERIORITY_OR_OTHER||R-square|0.02||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration at 12 months of age for the serogroup A||||
72370687|NCT00488683|144251642|SUPERIORITY_OR_OTHER||R-square|0.007||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration at 12 months of age for the serogroup C||||
72370688|NCT00488683|144251642|SUPERIORITY_OR_OTHER||R-square|0.04||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration at 12 months of age for the serogroup C||||
72503152|NCT02243176|144536884|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.18||0.8915|TWO_SIDED|95.0|-0.33|0.38|||Mixed Model Repeated Measures||Mean difference=Saxagliptin - Acarbose|||0.38|-0.33|0.8915
72503153|NCT02243176|144536885|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3|STANDARD_ERROR_OF_MEAN|0.249||0.2248|TWO_SIDED|95.0|-0.186|0.791|||ANCOVA||Mean difference=Saxagliptin - Acarbose|||0.791|-0.186|0.2248
72503154|NCT02243176|144536886|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.48|STANDARD_ERROR_OF_MEAN|8.407||0.3739|TWO_SIDED|95.0|-9.039|24.005|||ANCOVA||Mean difference=Saxagliptin - Acarbose|||24.005|-9.039|0.3739
72503155|NCT02243176|144536887|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.69|STANDARD_ERROR_OF_MEAN|0.26||0.0078|TWO_SIDED|95.0|0.18|1.19|||Mixed Model Repeated Measures||Mean difference=Saxagliptin - Acarbose|||1.19|0.18|0.0078
72504832|NCT01832961|144540550|OTHER||||||<|0.05|||||||Friedman's Test|Friedman's test followed by Dunn's multiple comparison||The statistical analysis compared the results: immediately after to baseline values, after 20 minutes of rest to baseline values and after 20 minutes of rest to values immediately after using Friedman's Test followed by Dunn's multiple comparison test|The effect of size used to calculate responsiveness and classified as small (0.2), moderate (0.5) and large (0.8).|||<0.05
72504833|NCT01832961|144540551|OTHER||||||<|0.05|||||||Friedman's Test|||The statistical analysis compared the results: immediately after to baseline values, after 20 minutes of rest to baseline values and after 20 minutes of rest to values immediately after using Friedman's Test followed by Dunn's multiple comparison test|The effect size was used to calculate responsiveness and classifed as small (0.2), moderate (0.5) and large (0.8)|||<0.05
72504834|NCT01832961|144540552|OTHER||||||<|0.05|||||||Friedman's Test|||The statistical analysis compared the results: immediately after to baseline values, after 20 minutes of rest to baseline values and after 20 minutes of rest to values immediately after using Friedman's Test followed by Dunn's multiple comparison test|The effect size was used to calculate responsiveness and classifed as small (0.2), moderate (0.5) and large (0.8)|||<0.05
72504835|NCT01832961|144540553|OTHER||||||<|0.05|||||||T-test|T-test was used to comparisons before and after FeNO results||||||<0.05
72504836|NCT01832961|144540554|OTHER||||||<|0.05|||||||T-test|||||||<0.05
72504837|NCT01274897|144540596|SUPERIORITY_OR_OTHER||Lower limit of the two-sided 95% CI|71.0|||||TWO_SIDED|95.0|71.0|81.0||The immune response considered sufficient if for serogroup A the lower limit of the two-sided 95% Clopper-Pearson confidence interval (CI) of the percentage of subjects with hSBA seroresponse is ≥50%.|Clopper and Pearson||For serogroup A.|The null hypothesis associated with the primary immunogenicity objective is that for at least one of the four serogroups, the percentage of subjects with hSBA seroresponse at 29 days postvaccination is \< 50%.||81|71|
72504838|NCT01274897|144540596|SUPERIORITY_OR_OTHER||Lower limit of the two-sided 95% CI|82.0|||||TWO_SIDED|95.0|82.0|90.0||The immune response was considered sufficient if for serogroup C, the lower limit of the two-sided 95% CI of the percentage of subjects with hSBA seroresponse was ≥50%.|Clopper and Pearson||For the serogroup C|The null hypothesis associated with the primary immunogenicity objective is that for at least one of the four serogroups, the percentage of subjects with hSBA seroresponse at 29 days postvaccination is \< 50%.||90|82|
72504839|NCT01274897|144540596|SUPERIORITY_OR_OTHER||Lower limit of the two-sided 95% CI|23.0|||||TWO_SIDED|95.0|23.0|33.0||The immune response was considered sufficient if for serogroup W, the lower limit of the two-sided 95% CI of the percentage of subjects with hSBA seroresponse was ≥50%.|Clopper and Pearson||For the serogroup W|The null hypothesis associated with the primary immunogenicity objective is that for at least one of the four serogroups, the percentage of subjects with hSBA seroresponse at 29 days postvaccination is \< 50%.||33|23|
72504840|NCT01274897|144540596|SUPERIORITY_OR_OTHER||Lower limit of the two-sided 95% CI|63.0|||||TWO_SIDED|95.0|63.0|74.0||The immune response was considered sufficient if for serogroup Y, the lower limit of the two-sided 95% CI of the percentage of subjects with hSBA seroresponse was ≥50%.|Clopper and Pearson||For serogroup Y|The null hypothesis associated with the primary immunogenicity objective is that for at least one of the four serogroups, the percentage of subjects with hSBA seroresponse at 29 days postvaccination is \< 50%.||74|63|
72504841|NCT00035815|144540601|SUPERIORITY_OR_OTHER|||||||0.529||95.0|||||Wilcoxon (Mann-Whitney)|||Analysis of MMT was calculated as a ratio of change from baseline to last follow-up to time to duration until last follow-up. For the patients that died during the study period, the last follow-up time was considered as the time of death with a zero score for MMT measurement. Analysis was performed using intention to treat approach. Comparison of rate of change in MMT scores between the placebo and IGF-1 group was made using two sample t-test or Wilcoxon rank sum test as appropriate.||||0.529
72394478|NCT01753856|144295759|SUPERIORITY_OR_OTHER|||||||0.031|TWO_SIDED|||||DL and Imputed SL, in EC.|Wilcoxon (Mann-Whitney)|||||||0.031
72503156|NCT03063385|144536890|OTHER|\[Not specified\]|Slope|0.0153|STANDARD_ERROR_OF_MEAN|0.0067||0.0229|TWO_SIDED|95.0|0.0022|0.0285||Statistical significance taken at the 0.05 level|GEE modeling|P-value \& estimate rely on group x time interaction effect on primary outcome when controlling for self-efficacy. Used modified Baron \& Kenny method|\[Not specified\]|The intervention effect of sexual risk communication (primary outcome in parents) controlling for self-efficacy as a mediator from baseline through 12 months was examined using longitudinal general estimating equations (GEE) modeling, with the Health promotion control condition as the reference category and adjusting for baseline sexual risk communication and average monthly income.||0.0285|0.0022|.0229
72394479|NCT01753856|144295759|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||DL Only, in IC.|Wilcoxon (Mann-Whitney)|||||||<0.001
72503157|NCT03063385|144536890|OTHER|\[Not specified\]|Slope|0.0151|STANDARD_ERROR_OF_MEAN|0.0067||0.0249|TWO_SIDED|95.0|0.0019|0.0282||Statistical significance taken at the 0.05 level|GEE modeling|P-value and estimate rely on group x time interaction effect on primary outcome when controlling for sexual communication attitudes. Same method B\&K|\[Not specified\]|The intervention effect of sexual risk communication (primary outcome in parents) controlling for sexual communication attitudes as a mediator from baseline through 12 months was examined using longitudinal general estimating equations (GEE) modeling, with the Health promotion control condition as the reference category and adjusting for baseline sexual risk communication and average monthly income.||0.0282|0.0019|0.0249
72370689|NCT00488683|144251642|SUPERIORITY_OR_OTHER||R-square|0.02||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration at 12 months of age for the serogroup W-135||||
72564414|NCT02310763|144660489|SUPERIORITY||Mean Difference (Net)|-0.3289||||0.1353|TWO_SIDED|95.0|-0.7649|0.1072||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC\<3.5 seconds||0.1072|-0.7649|0.1353
72564415|NCT02310763|144660489|SUPERIORITY||Mean Difference (Net)|0.3457||||0.7648|TWO_SIDED|95.0|-1.9614|2.6528||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC\>=3.5 and \<=8 seconds||2.6528|-1.9614|0.7648
72621574|NCT02732145|144773202|SUPERIORITY|Question: Is there a difference in the incidence of vulvar soreness depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvodynia?||||||0.3953|||||||Chi-squared|||Parameter: The incidence of vulvar soreness depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvodynia.||||0.3953
72466136|NCT01475461|144455392|SUPERIORITY_OR_OTHER||Least squares (LS) Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.172||0.5206|TWO_SIDED|80.0|-0.21|0.23||p-value was 1-sided.|t-test, 1 sided|No adjustments were made for multiple comparisons among treatment groups.||Week 12: Treatment difference and 80 percent(%) confidence interval (CI) were based on least squares (LS) mean. A mixed model repeated measure (MMRM) analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant. Null hypothesis stated there was no difference between PF 04937319 and placebo, alternative hypothesis stated PF 04937319 was superior to placebo.||0.23|-0.21|0.5206
72466137|NCT01475461|144455392|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.178||0.1645|TWO_SIDED|80.0|-0.4|0.05||p-value was 1-sided.|t-test, 1 sided|No adjustments were made for multiple comparisons among treatment groups.||Week 12: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant. Null hypothesis stated there was no difference between PF 04937319 and placebo, alternative hypothesis stated PF 04937319 was superior to placebo||0.05|-0.40|0.1645
72466138|NCT01475461|144455392|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.172||0.1592|TWO_SIDED|80.0|-0.39|0.05||p-value was 1-sided.|t-test, 1 sided|No adjustments were made for multiple comparisons among treatment groups.||Week 12: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant. Null hypothesis stated there was no difference between PF 04937319 and placebo, alternative hypothesis stated PF 04937319 was superior to placebo.||0.05|-0.39|0.1592
72466139|NCT01475461|144455392|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.45|STANDARD_ERROR_OF_MEAN|0.174||0.0049|TWO_SIDED|80.0|-0.68|-0.23||p-value was 1-sided.|t-test, 1 sided|||Week 12: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant. Null hypothesis stated there was no difference between PF 04937319 and placebo, alternative hypothesis stated PF 04937319 was superior to placebo.||-0.23|-0.68|0.0049
72466140|NCT01475461|144455392|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.43|STANDARD_ERROR_OF_MEAN|0.173||0.0068|TWO_SIDED|80.0|-0.65|-0.21||p-value was 1-sided.|t-test, 1 sided|||Week 12: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant. Null hypothesis stated there was no difference between PF 04937319 and placebo, alternative hypothesis stated PF 04937319 was superior to placebo.||-0.21|-0.65|0.0068
72466141|NCT01475461|144455393|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.097||0.3434|TWO_SIDED|80.0|-0.16|0.09||p-value was 1-sided.|t-test, 1 sided|||Week 4: Treatment difference and 80 percent(%) confidence interval (CI) were based on least squares (LS) mean. A mixed model repeated measure (MMRM) analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.09|-0.16|0.3434
72466142|NCT01475461|144455393|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.101||0.0892|TWO_SIDED|80.0|-0.27|-0.01||p-value was 1-sided.|t-test, 1 sided|||Week 4: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, as the covariates, time was repeated for participant.||-0.01|-0.27|0.0892
72466143|NCT01475461|144455393|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.097||0.0826|TWO_SIDED|80.0|-0.26|-0.01||p-value was 1-sided.|t-test, 1 sided|||Week 4: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, as the covariates, time was repeated for participant.||-0.01|-0.26|0.0826
72394480|NCT01753856|144295759|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||DL and Imputed SL, in IC.|Wilcoxon (Mann-Whitney)|||||||<0.001
72394481|NCT01753856|144295760|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<0.001
72466144|NCT01475461|144455393|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.27|STANDARD_ERROR_OF_MEAN|0.098||0.0031|TWO_SIDED|80.0|-0.4|-0.15||p-value was 1-sided.|t-test, 1 sided|||Week 4: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, as the covariates, time was repeated for participant.||-0.15|-0.40|0.0031
72466145|NCT01475461|144455393|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.33|STANDARD_ERROR_OF_MEAN|0.098||0.0005|TWO_SIDED|80.0|-0.45|-0.2||p-value was 1-sided.|t-test, 1 sided|||Week 4: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||-0.20|-0.45|0.0005
72466146|NCT01475461|144455393|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.144||0.5133|TWO_SIDED|80.0|-0.18|0.19||p-value was 1-sided.|t-test, 1 sided|||Week 8: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.19|-0.18|0.5133
72564416|NCT02310763|144660489|SUPERIORITY||Mean Difference (Net)|8.2893||||0.3562|TWO_SIDED|95.0|-9.6409|26.2194||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC\>8 seconds||26.2194|-9.6409|0.3562
72564417|NCT02310763|144660490|SUPERIORITY||Mean Difference (Net)|-0.5582||||0.1163||95.0|-1.2615|0.1451||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC\<3.5 seconds||0.1451|-1.2615|0.1163
72394482|NCT01753856|144295761|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||CC.|Wilcoxon (Mann-Whitney)|||||||<0.001
72394483|NCT01753856|144295761|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||EC.|Wilcoxon (Mann-Whitney)|||||||<0.001
72394484|NCT01753856|144295761|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||IC.|Wilcoxon (Mann-Whitney)|||||||<0.001
72394485|NCT01753856|144295762|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||CC.|Wilcoxon (Mann-Whitney)|||||||<0.001
72394486|NCT01753856|144295762|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||EC.|Wilcoxon (Mann-Whitney)|||||||<0.001
72394487|NCT01753856|144295762|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||IC.|Wilcoxon (Mann-Whitney)|||||||<0.001
72564418|NCT02310763|144660490|SUPERIORITY||Mean Difference (Net)|0.0944||||0.9503|TWO_SIDED|95.0|-3.0798|3.2686||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC\>=3.5 and \<=8 seconds||3.2686|-3.0798|0.9503
72564419|NCT02310763|144660490|SUPERIORITY||Mean Difference (Net)|-11.2881||||0.2947|TWO_SIDED|95.0|-32.8328|10.2566||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC\>8 seconds||10.2566|-32.8328|0.2947
72564420|NCT02310763|144660491|SUPERIORITY||Mean Difference (Net)|0.0159||||0.8229|TWO_SIDED|95.0|-0.127|0.1588||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC\<3.5 seconds||0.1588|-0.1270|0.8229
72621575|NCT02732145|144773202|SUPERIORITY|Question: Is there a difference in the incidence of vulvar irritation depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvodynia?||||||0.0921|||||||Chi-squared|||Parameter: The incidence of vulvar irritation depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvodynia.||||0.0921
72621576|NCT02732145|144773202|SUPERIORITY|Question: Is there a difference in the incidence of vulvar itching depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvodynia?||||||0.6734|||||||Chi-squared|||Parameter: The incidence of vulvar itching depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvodynia.||||0.6734
72621577|NCT02732145|144773202|SUPERIORITY|Question: Is there a difference in the incidence of the feeling of vulvar inflammation depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvodynia?||||||0.3458|||||||Chi-squared|||Parameter: The incidence of the feeling of vulvar inflammation depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvodynia.||||0.3458
72621578|NCT02732145|144773202|SUPERIORITY|Question: Is there a difference in the incidence of vulvar aching depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvodynia?||||||0.5304|||||||Chi-squared|||Parameter: The incidence of vulvar aching depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvodynia.||||0.5304
72621579|NCT02732145|144773202|SUPERIORITY|Question: Is there a difference in the incidence of symptoms of the sharp pain depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvodynia?||||||0.0012|||||||Chi-squared|||Parameter: The difference in the incidence of symptoms of the sharp (fast) pain depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvodynia.||||0.0012
72394488|NCT01753856|144295763|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Average length of DLs in the CC|ANCOVA|ANCOVA model with treatment group as the main effect and baseline MS/BS as a covariate.||||||<0.001
72394489|NCT01753856|144295763|SUPERIORITY_OR_OTHER|||||||0.004|TWO_SIDED|||||Average length of double labels in EC|ANCOVA|ANCOVA model with treatment group as the main effect and baseline MS/BS as a covariate.||||||0.004
72394490|NCT01753856|144295763|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Average length of double labels in IC|ANCOVA|ANCOVA model with treatment group as the main effect and baseline MS/BS as a covariate.||||||<0.001
72394491|NCT01753856|144295763|SUPERIORITY_OR_OTHER|||||||0.85|TWO_SIDED|||||Average length of double labels in the PC|ANCOVA|ANCOVA model with treatment group as the main effect and baseline MS/BS as a covariate.||||||0.850
72394492|NCT01753856|144295764|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||CC.|Wilcoxon (Mann-Whitney)|||||||<0.001
72394493|NCT01753856|144295764|SUPERIORITY_OR_OTHER|||||||0.042|TWO_SIDED|||||EC.|Wilcoxon (Mann-Whitney)|||||||0.042
72394494|NCT01753856|144295764|SUPERIORITY_OR_OTHER|||||||0.678|TWO_SIDED|||||IC.|Wilcoxon (Mann-Whitney)|||||||0.678
72394495|NCT01753856|144295765|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||CC|Wilcoxon (Mann-Whitney)|||||||<0.001
72394496|NCT01753856|144295765|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||EC|Wilcoxon (Mann-Whitney)|||||||<0.001
72394497|NCT01753856|144295765|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||IC|Wilcoxon (Mann-Whitney)|||||||<0.001
72394498|NCT00064844|144295769|SUPERIORITY_OR_OTHER_LEGACY||chi square|7.25|||<|0.01||95.0|||||Chi-squared|df = 1, N = 96||||||<0.01
72394499|NCT04847557|144295774|SUPERIORITY||Median Difference (Net)|6.9|||<|0.001|TWO_SIDED|95.0|3.3|10.6|||Stratified Wilcoxon|Stratified Wilcoxon test used to control for stratification factors of HF decompensation within 12 months of screening,diagnosed T2DM \& baseline BMI|The Hodges-Lehmann estimate for the median difference and 95% CIs was reported.|||10.6|3.3|<0.001
72564421|NCT02310763|144660491|SUPERIORITY||Mean Difference (Net)|-0.0132||||0.7709|TWO_SIDED|95.0|-0.1036|0.0772||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC\>=3.5 and \<=8 seconds||0.0772|-0.1036|0.7709
72564422|NCT02310763|144660491|SUPERIORITY||Mean Difference (Net)|0.0889||||0.3746|TWO_SIDED|95.0|-0.1219|0.2996||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC\>8 seconds||0.2996|-0.1219|0.3746
72564423|NCT02310763|144660492|SUPERIORITY||Mean Difference (Net)|-0.0934||||0.2294|TWO_SIDED|95.0|-0.2481|0.0613||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC\<3.5 seconds||0.0613|-0.2481|0.2294
72564424|NCT02310763|144660492|SUPERIORITY||Mean Difference (Net)|-0.0117||||0.8485|TWO_SIDED|95.0|-0.1339|0.1105||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC\>=3.5 and \<= 8 seconds||0.1105|-0.1339|0.8485
72564425|NCT02310763|144660492|SUPERIORITY||Mean Difference (Net)|0.0562||||0.6645|TWO_SIDED|95.0|-0.2187|0.3312||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC\>8 seconds||0.3312|-0.2187|0.6645
72394500|NCT04847557|144295775|SUPERIORITY||Hazard Ratio (HR)|0.62||||0.026|TWO_SIDED|95.0|0.41|0.95|||Regression, Cox|||Heart Failure Outcomes||0.95|0.41|0.026
72503158|NCT03063385|144536890|OTHER|\[Not specified\]|Slope|0.0158|STANDARD_ERROR_OF_MEAN|0.0068||0.0204|TWO_SIDED|95.0|0.0025|0.0292||Statistical significance taken at the 0.05 level|GEE modeling|Reported P-value and estimate rely on the group x time interaction effect on primary outcome when controlling for subjective norms. Same method B\&K|\[Not specified\]|The intervention effect of sexual risk communication (primary outcome in parents) controlling for subjective norms as a mediator from baseline through 12 months was examined using longitudinal general estimating equations (GEE) modeling, with the Health promotion control condition as the reference category and adjusting for baseline sexual risk communication and average monthly income.||0.0292|0.0025|0.0204
72503159|NCT03704051|144536906|EQUIVALENCE|A priori power analysis based on pilot testing with 12 dyads indicated that a sample size of at least 40 dyads would provide 80% power to detect significant within-subjects (condition, i.e., breastfeeding directly from the breast vs. bottle-feeding expressed breast milk) effects at an α = 0.05 Type I error level.||||||0.634|||||||Mixed Models Analysis|All models adjusted for order of conditions, time since last feeding and infant age.||||||0.634
72503160|NCT03704051|144536907|EQUIVALENCE|A priori power analysis based on pilot testing with 12 dyads indicated that a sample size of at least 40 dyads would provide 80% power to detect significant within-subjects (condition, i.e., breastfeeding directly from the breast vs. bottle-feeding expressed breast milk) effects at an α = 0.05 Type I error level.||||||0.115|||||||Mixed Models Analysis|All models adjusted for order of conditions, time since last feeding and infant age.||||||0.115
72503161|NCT01943539|144536910|SUPERIORITY||Effect Size|0.62||||0.008|TWO_SIDED||||||t-test, 2 sided|||||||0.008
72394501|NCT04847557|144295776|SUPERIORITY||Median Difference (Net)|18.3|||<|0.001|TWO_SIDED|95.0|9.9|26.7|||Stratified Wilcoxon|Stratified Wilcoxon test used to control for stratification factors of HF decompensation within 12 months of screening,diagnosed T2DM \& baseline BMI|The Hodges-Lehmann estimate for the median difference and 95% CIs was reported.|||26.7|9.9|<0.001
72394502|NCT04847557|144295777|SUPERIORITY||LS Mean Difference|-11.62|||<|0.001|TWO_SIDED|95.0|-12.85|-10.38|||ANCOVA|||||-10.38|-12.85|<0.001
72394503|NCT04847557|144295778|SUPERIORITY||LS Mean Difference|-34.91|||<|0.001|TWO_SIDED|95.0|-45.6|-22.17|||ANCOVA|||||-22.17|-45.60|<0.001
72503162|NCT00345605|144536916|SUPERIORITY_OR_OTHER||Slope|0.5|||||TWO_SIDED||||||||Assuming r=0.5 between two measurements from the same subject, 12 subjects would provide a power of 0.8 to detect a 10% reduction in primary endpoints at an alpha value of 0.05.|For sample size calculation, we used the means and standard deviation for PT, PTT. Assuming r=0.5 between two measurements from the same subject, 12 subjects would provide a power of 0.8 to detect a 10% reduction in primary endpoints at an alpha value of 0.05.||||
72503163|NCT01335971|144536923|SUPERIORITY_OR_OTHER|||||||0.45|||||||Kruskal-Wallis|||Applies to gene expression of NAD(P)H Quinone Dehydrogenase 1 (NQ01) in alveolar macrophages||||0.45
72503164|NCT01335971|144536923|SUPERIORITY_OR_OTHER|||||||0.4|||||||Kruskal-Wallis|||Applies to gene expression of Heme Oxygenase 1 (HO1) in alveolar macrophages||||0.40
72503165|NCT01335971|144536923|SUPERIORITY_OR_OTHER|||||||0.75|||||||Kruskal-Wallis|||Applies to gene expression of Aldo-Keto Reductase Family 1 Member C1 (AKR1C1) in alveolar macrophages||||0.75
72503166|NCT01335971|144536923|SUPERIORITY_OR_OTHER|||||||0.49|||||||Kruskal-Wallis|||Applies to gene expression of Aldo-Keto Reductase Family 1 Member C3 (AKR1C3) in alveolar macrophages||||0.49
72503167|NCT01335971|144536923|SUPERIORITY_OR_OTHER|||||||0.88|||||||Kruskal-Wallis|||Applies to gene expression of nuclear factor erythroid 2 like 2 (Nrf2) in alveolar macrophages||||0.88
72503168|NCT01335971|144536923|SUPERIORITY_OR_OTHER|||||||0.71|||||||Kruskal-Wallis|||Applies to gene expression of Kelch Like ECH Associated Protein 1 (Keap1) in alveolar macrophages||||0.71
72503169|NCT01335971|144536924|SUPERIORITY_OR_OTHER|||||||0.68|||||||Kruskal-Wallis|||Applies to gene expression of Nrf2 in bronchial epithelial cells||||0.68
72503170|NCT01335971|144536925|SUPERIORITY_OR_OTHER|||||||0.69|||||||Kruskal-Wallis|||Applies to gene expression of NAD(P)H Quinone Dehydrogenase 1 (NQ01) in bronchial epithelial cells||||0.69
72503171|NCT01335971|144536925|SUPERIORITY_OR_OTHER||||||<|0.01|||||||Kruskal-Wallis|||Applies to gene expression of Kelch Like ECH Associated Protein 1 (Keap1) in bronchial epithelial cells||||<0.01
72503172|NCT01335971|144536926|SUPERIORITY_OR_OTHER|||||||0.53|||||||Kruskal-Wallis|||Applies to gene expression of Heme Oxygenase 1 (HO1) in bronchial epithelial cells||||0.53
72503173|NCT01335971|144536927|SUPERIORITY_OR_OTHER||||||<|0.01|||||||Kruskal-Wallis|||Applies to gene expression of Aldo-Keto Reductase Family 1 Member C1 (AKR1C1) in bronchial epithelial cells.||||<0.01
72466147|NCT01475461|144455393|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.15||0.1873|TWO_SIDED|80.0|-0.33|0.06||p-value was 1-sided.|t-test, 1 sided|||Week 8: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.06|-0.33|0.1873
72564426|NCT02310763|144660493|SUPERIORITY||Mean Difference (Net)|-0.1013||||0.2101|TWO_SIDED|95.0|-0.2622|0.0597||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC\<3.5 seconds||0.0597|-0.2622|0.2101
72466148|NCT01475461|144455393|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.145||0.212|TWO_SIDED|80.0|-0.3|0.07||p-value was 1-sided.|t-test, 1 sided|||Week 8: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.07|-0.30|0.2120
72564427|NCT02310763|144660493|SUPERIORITY||Mean Difference (Net)|-0.0359||||0.4603|TWO_SIDED|95.0|-0.1326|0.0608||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC\>=3.5 and \<= 8 seconds||0.0608|-0.1326|0.4603
72466149|NCT01475461|144455393|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.54|STANDARD_ERROR_OF_MEAN|0.146||0.0001|TWO_SIDED|80.0|-0.73|-0.35||p-value was 1-sided.|t-test, 1 sided|||Week 8: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, as the covariates, time was repeated for participant.||-0.35|-0.73|0.0001
72564428|NCT02310763|144660493|SUPERIORITY||Mean Difference (Net)|0.1039||||0.3739|TWO_SIDED|95.0|-0.1386|0.3463||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC\>8 seconds||0.3463|-0.1386|0.3739
72466150|NCT01475461|144455393|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.42|STANDARD_ERROR_OF_MEAN|0.146||0.0021|TWO_SIDED|80.0|-0.61|-0.23||p-value was 1-sided.|t-test, 1 sided|||Week 8: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||-0.23|-0.61|0.0021
72466151|NCT01475461|144455394|SUPERIORITY_OR_OTHER||LS Mean Difference|2.87|STANDARD_ERROR_OF_MEAN|4.823||0.724|TWO_SIDED|80.0|-3.32|9.07||p-value was 1-sided.|t-test, 1 sided|||Week 2: Treatment difference and 80 percent(%) confidence interval (CI) were based on least squares (LS) mean. A mixed model repeated measure (MMRM) analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||9.07|-3.32|0.7240
72466152|NCT01475461|144455394|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.77|STANDARD_ERROR_OF_MEAN|4.952||0.3608|TWO_SIDED|80.0|-8.13|4.59||p-value was 1-sided.|t-test, 1 sided|||Week 2: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||4.59|-8.13|0.3608
72466153|NCT01475461|144455394|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.24|STANDARD_ERROR_OF_MEAN|4.816||0.2511|TWO_SIDED|80.0|-9.42|2.95||p-value was 1-sided.|t-test, 1 sided|||Week 2: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||2.95|-9.42|0.2511
72564429|NCT02310763|144660494|SUPERIORITY||Mean Difference (Net)|-0.3||||0.8925|TWO_SIDED|95.0|-4.5|3.9||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC\<3.5 seconds||3.9|-4.5|0.8925
72564430|NCT02310763|144660494|SUPERIORITY||Mean Difference (Net)|1.2||||0.2107|TWO_SIDED|95.0|-0.7|3.2||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC\>=3.5 and \<=8 seconds||3.2|-0.7|0.2107
72621580|NCT02732145|144773202|SUPERIORITY|Question: Is there a difference in the incidence of vulvar knife-like pain depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvodynia?||||||0.0002|||||||Chi-squared|||Parameter: The incidence of vulvar knife-like pain depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvodynia.||||0.0002
72621581|NCT02732145|144773202|SUPERIORITY|Question: Is there a difference in the incidence of vulvar paper-cuts pain depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvodynia?||||||0.0218|||||||Chi-squared, Corrected|||Parameter: The incidence of vulvar paper-cuts pain depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvodynia.||||0.0218
72621582|NCT02732145|144773202|SUPERIORITY|Question: Is there a difference in the incidence of vulvar pain like stabbing depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvodynia?||||||0.0297|||||||Chi-squared|||Parameter: The incidence of vulvar pain like stabbing depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvodynia.||||0.0297
72621583|NCT02732145|144773202|SUPERIORITY|Question: Is there a difference in the incidence of vulvar pain like sticking depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvodynia?||||||0.6468|||||||Chi-squared|||Parameter: The incidence of vulvar pain like sticking depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvodynia.||||0.6468
72621584|NCT02732145|144773203|SUPERIORITY|Question: Is there a difference in the incidence of the finding of inflammatory infiltrates in vulvar specimens from patients with vulvar dermatosis depending on the duration of vulvar discomfort for less or more than 24 months?||||||0.2045|||||||Chi-squared|||Parameter: The difference in the incidence of the histopathological finding of inflammatory infiltrates in vulvar specimens from patients with vulvar dermatosis depending on the duration of vulvar discomfort.||||0.2045
72621585|NCT02732145|144773203|SUPERIORITY|Question: Is there a difference in the incidence of the finding of mononuclear inflammatory infiltrates in vulvar specimens from patients with vulvar dermatosis depending on the duration of vulvar discomfort for less or more than 24 months?||||||0.7469|||||||Chi-squared|||Parameter: The difference in the incidence of the histopathological finding of mononuclear inflammatory infiltrates in vulvar specimens from patients with vulvar dermatosis depending on the duration of vulvar discomfort.||||0.7469
72621586|NCT02732145|144773203|SUPERIORITY|Question: Is there a difference in the incidence of the finding of lymphocytes in vulvar specimens from patients with vulvar dermatosis depending on the duration of vulvar discomfort for less or more than 24 months?||||||0.4271|||||||Chi-squared|||Parameter: The difference in the incidence of the histopathological finding of lymphocytes in vulvar specimens from patients with vulvar dermatosis depending on the duration of vulvar discomfort.||||0.4271
72621587|NCT02732145|144773203|SUPERIORITY|Question: Is there a difference in the incidence of the finding of collagen fibers in vulvar specimens from patients with vulvar dermatosis depending on the duration of vulvar discomfort for less or more than 24 months?||||||0.3607|||||||Chi-squared|||Parameter: The difference in the incidence of the histopathological finding of collagen fibers in vulvar specimens from patients with vulvar dermatosis depending on the duration of vulvar discomfort.||||0.3607
72621588|NCT02732145|144773203|SUPERIORITY|Question: Is there a difference in the incidence of the finding of hyalinization in vulvar specimens from patients with vulvar dermatosis depending on the duration of vulvar discomfort for less or more than 24 months?||||||0.8672|||||||Chi-squared|||Parameter: The difference in the incidence of the histopathological finding of hyalinization in vulvar specimens from patients with vulvar dermatosis depending on the duration of vulvar discomfort.||||0.8672
72503174|NCT01335971|144536928|SUPERIORITY_OR_OTHER|||||||0.06|||||||Kruskal-Wallis|||Applies to gene expression of Aldo-Keto Reductase Family 1 Member C3 (AKR1C3) in bronchial epithelial cells.||||0.06
72503175|NCT01335971|144536929|SUPERIORITY_OR_OTHER|||||||0.2|||||||Kruskal-Wallis|||||||0.20
72503176|NCT01335971|144536930|SUPERIORITY_OR_OTHER|||||||0.41|||||||Kruskal-Wallis|||Applies to C-reactive protein concentration||||0.41
72503177|NCT01335971|144536930|SUPERIORITY_OR_OTHER|||||||0.07|||||||Kruskal-Wallis|||Applies to Interleukin-6 concentration||||0.07
72503178|NCT01335971|144536930|SUPERIORITY_OR_OTHER|||||||0.65|||||||Kruskal-Wallis|||Applies to Interleukin-8 concentration||||0.65
72466154|NCT01475461|144455394|SUPERIORITY_OR_OTHER||LS Mean Difference|-7.28|STANDARD_ERROR_OF_MEAN|4.851||0.0673|TWO_SIDED|80.0|-13.51|-1.05||p-value was 1-sided.|t-test, 1 sided|||Week 2: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||-1.05|-13.51|0.0673
72466155|NCT01475461|144455394|SUPERIORITY_OR_OTHER||LS Mean Difference|-11.22|STANDARD_ERROR_OF_MEAN|4.843||0.0106|TWO_SIDED|80.0|-17.44|-5.0||p-value was 1-sided.|t-test, 1 sided|||Week 2: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||-5.00|-17.44|0.0106
72466156|NCT01475461|144455394|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.13|STANDARD_ERROR_OF_MEAN|5.138||0.4127|TWO_SIDED|80.0|-7.73|5.47||p-value was 1-sided.|t-test, 1 sided|||Week 4: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||5.47|-7.73|0.4127
72466157|NCT01475461|144455394|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.88|STANDARD_ERROR_OF_MEAN|5.261||0.3604|TWO_SIDED|80.0|-8.64|4.87||p-value was 1-sided.|t-test, 1 sided|||Week 4: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||4.87|-8.64|0.3604
72466158|NCT01475461|144455394|SUPERIORITY_OR_OTHER||LS Mean Difference|-7.35|STANDARD_ERROR_OF_MEAN|5.147||0.077|TWO_SIDED|80.0|-13.96|-0.74||p-value was 1-sided.|t-test, 1 sided|||Week 4: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||-0.74|-13.96|0.0770
72466159|NCT01475461|144455394|SUPERIORITY_OR_OTHER||LS Mean Difference|-8.79|STANDARD_ERROR_OF_MEAN|5.171||0.0451|TWO_SIDED|80.0|-15.43|-2.15||p-value was 1-sided.|t-test, 1 sided|||Week 4: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||-2.15|-15.43|0.0451
72466160|NCT01475461|144455394|SUPERIORITY_OR_OTHER||LS Mean Difference|-19.9|STANDARD_ERROR_OF_MEAN|5.191||0.0001|TWO_SIDED|80.0|-26.57|-13.23||p-value was 1-sided.|t-test, 1 sided|||Week 4: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||-13.23|-26.57|0.0001
72466161|NCT01475461|144455394|SUPERIORITY_OR_OTHER||LS Mean Difference|1.11|STANDARD_ERROR_OF_MEAN|5.599||0.5783|TWO_SIDED|80.0|-6.08|8.3||p-value was 1-sided.|t-test, 1 sided|||Week 8: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||8.30|-6.08|0.5783
72466162|NCT01475461|144455394|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.07|STANDARD_ERROR_OF_MEAN|5.785||0.3604|TWO_SIDED|80.0|-9.5|5.36||p-value was 1-sided.|t-test, 1 sided|||Week 8: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||5.36|-9.50|0.3604
72466163|NCT01475461|144455394|SUPERIORITY_OR_OTHER||LS Mean Difference|-12.12|STANDARD_ERROR_OF_MEAN|5.636||0.0161|TWO_SIDED|80.0|-19.36|-4.88||p-value was 1-sided.|t-test, 1 sided|||Week 8: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||-4.88|-19.36|0.0161
72621589|NCT02732145|144773204|SUPERIORITY|Question: Is there a difference in the incidence of the finding of inflammatory infiltrates in vulvar specimens from patients with vulvodynia depending on the duration of vulvar discomfort for less or more than 24 months?||||||0.0045|||||||Chi-squared|||Parameter: The difference in the incidence of the histopathological finding of inflammatory infiltrates in vulvar specimens from patients with vulvodynia depending on the duration of vulvar discomfort.||||0.0045
72466164|NCT01475461|144455394|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.41|STANDARD_ERROR_OF_MEAN|5.663||0.2185|TWO_SIDED|80.0|-11.68|2.87||p-value was 1-sided.|t-test, 1 sided|||Week 8: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||2.87|-11.68|0.2185
72503179|NCT01335971|144536931|SUPERIORITY_OR_OTHER|||||||0.71|||||||Kruskal-Wallis|||Applies to interleukin-8 results||||0.71
72503180|NCT01335971|144536931|SUPERIORITY_OR_OTHER|||||||0.33|||||||Kruskal-Wallis|||Applies to secretory leukoprotease inhibitor results||||0.33
72503181|NCT01335971|144536932|SUPERIORITY_OR_OTHER|||||||0.8|||||||Kruskal-Wallis|||Applies to isoprostane results.||||0.80
72503182|NCT01335971|144536932|SUPERIORITY_OR_OTHER|||||||0.35|||||||Kruskal-Wallis|||Applies to thiobarbituric acid reactive substances results.||||0.35
72503183|NCT01335971|144536932|SUPERIORITY_OR_OTHER|||||||0.53|||||||Kruskal-Wallis|||Applies to total antioxidants results.||||0.53
72503184|NCT03351244|144536979|OTHER||Hazard Ratio (HR)|1.097||||0.7735|TWO_SIDED|95.0|0.585|2.056|||Regression, Cox|The model included the treatment effect as the only covariate and was stratified by country.||||2.056|0.585|0.7735
72503185|NCT03351244|144536979|OTHER||Hazard Ratio (HR)|0.91||||0.7809|TWO_SIDED|95.0|0.468|1.77|||Regression, Cox|The model included the treatment effect as the only covariate and was stratified by country.||||1.770|0.468|0.7809
72503186|NCT03351244|144536979|OTHER||Hazard Ratio (HR)|1.005||||0.9862|TWO_SIDED|95.0|0.576|1.753|||Regression, Cox|The model included the treatment effect as the only covariate and was stratified by country.||||1.753|0.576|0.9862
72503187|NCT03351244|144536980|OTHER|A restricted maximum likelihood-based approach using a mixed model with repeated measurements was applied.|Placebo-corrected adjusted mean|0.38||||0.5289|TWO_SIDED|95.0|-0.809|1.57|||Mixed model with repeated measurements|The analysis included the fixed, categorical effects of treatment at each visit, and the fixed continuous effects of baseline at each visit.||||1.570|-0.809|0.5289
72503188|NCT03351244|144536980|OTHER|A restricted maximum likelihood-based approach using a mixed model with repeated measurements was applied.|Placebo-corrected adjusted mean|0.21||||0.744|TWO_SIDED|95.0|-1.055|1.475|||Mixed model with repeated measurements|The analysis included the fixed, categorical effects of treatment at each visit, and the fixed continuous effects of baseline at each visit.||||1.475|-1.055|0.7440
72503189|NCT03351244|144536980|OTHER|A restricted maximum likelihood-based approach using a mixed model with repeated measurements was applied.|Placebo-corrected adjusted mean|0.31||||0.5659|TWO_SIDED|95.0|-0.745|1.358|||Mixed model with repeated measurements|The analysis included the fixed, categorical effects of treatment at each visit, and the fixed continuous effects of baseline at each visit.||||1.358|-0.745|0.5659
72466165|NCT01475461|144455394|SUPERIORITY_OR_OTHER||LS Mean Difference|-15.41|STANDARD_ERROR_OF_MEAN|5.649||0.0034|TWO_SIDED|80.0|-22.67|-8.16||p-value was 1-sided.|t-test, 1 sided|||Week 8: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||-8.16|-22.67|0.0034
72466166|NCT01475461|144455394|SUPERIORITY_OR_OTHER||LS Mean Difference|1.17|STANDARD_ERROR_OF_MEAN|6.387||0.5727|TWO_SIDED|80.0|-7.03|9.37||p-value was 1-sided.|t-test, 1 sided|||Week 12: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||9.37|-7.03|0.5727
72466167|NCT01475461|144455394|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.06|STANDARD_ERROR_OF_MEAN|6.578||0.4961|TWO_SIDED|80.0|-8.51|8.38||p-value was 1-sided.|t-test, 1 sided|||Week 12: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||8.38|-8.51|0.4961
72466168|NCT01475461|144455394|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.1|STANDARD_ERROR_OF_MEAN|6.411||0.2616|TWO_SIDED|80.0|-12.33|4.14||p-value was 1-sided.|t-test, 1 sided|||Week 12: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||4.14|-12.33|0.2616
72466169|NCT01475461|144455394|SUPERIORITY_OR_OTHER||LS Mean Difference|9.06|STANDARD_ERROR_OF_MEAN|6.441||0.9197|TWO_SIDED|80.0|0.79|17.34||p-value was 1-sided.|t-test, 1 sided|||Week 12: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||17.34|0.79|0.9197
72466170|NCT01475461|144455394|SUPERIORITY_OR_OTHER||LS Mean Difference|-8.76|STANDARD_ERROR_OF_MEAN|6.398||0.086|TWO_SIDED|80.0|-16.98|-0.54||p-value was 1-sided.|t-test, 1 sided|||Week 12: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||-0.54|-16.98|0.0860
72466171|NCT01475461|144455394|SUPERIORITY_OR_OTHER||LS Mean Difference|0.22|STANDARD_ERROR_OF_MEAN|6.476||0.5132|TWO_SIDED|80.0|-8.1|8.53||p-value was 1-sided.|t-test, 1 sided|||Week 14: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||8.53|-8.10|0.5132
72466172|NCT01475461|144455394|SUPERIORITY_OR_OTHER||LS Mean Difference|2.68|STANDARD_ERROR_OF_MEAN|6.676||0.656|TWO_SIDED|80.0|-5.89|11.26||p-value was 1-sided.|t-test, 1 sided|||Week 14: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||11.26|-5.89|0.6560
72503190|NCT03351244|144536983|OTHER||Hazard Ratio (HR)|1.006||||0.9938|TWO_SIDED|95.0|0.203|4.989|||Regression, Cox|The model included the treatment effect as the only covariate and was stratified by country.||||4.989|0.203|0.9938
72394504|NCT04847557|144295779|SUPERIORITY||Win Ratio|1.63|||||TWO_SIDED|95.0|1.17|2.28|||||The win ratio was reported as the measure of treatment effect based on the principle that each participant is compared with every other participant within each stratum in a pair-wise manner that proceeds in a hierarchical fashion.|||2.28|1.17|
72394505|NCT04847557|144295780|SUPERIORITY||Odds Ratio (OR)|2.28|||||TWO_SIDED|95.0|1.53|3.4||||||||3.40|1.53|
72466173|NCT01475461|144455394|SUPERIORITY_OR_OTHER||LS Mean Difference|6.17|STANDARD_ERROR_OF_MEAN|6.496||0.8285|TWO_SIDED|80.0|-2.17|14.52||p-value was 1-sided.|t-test, 1 sided|||Week 14: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||14.52|-2.17|0.8285
72564431|NCT02310763|144660494|SUPERIORITY||Mean Difference (Net)|1.3||||0.2298|TWO_SIDED|95.0|-0.9|3.5||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC\>8 seconds||3.5|-0.9|0.2298
72370690|NCT00488683|144251642|SUPERIORITY_OR_OTHER||R-square|0.08||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration at 12 months of age for the serogroup W-135||||
72466174|NCT01475461|144455394|SUPERIORITY_OR_OTHER||LS Mean Difference|15.98|STANDARD_ERROR_OF_MEAN|6.527||0.9925|TWO_SIDED|80.0|7.59|24.36||p-value was 1-sided.|t-test, 1 sided|||Week 14: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||24.36|7.59|0.9925
72466175|NCT01475461|144455394|SUPERIORITY_OR_OTHER||LS Mean Difference|1.66|STANDARD_ERROR_OF_MEAN|6.487||0.601|TWO_SIDED|80.0|-6.67|10.0||p-value was 1-sided.|t-test, 1 sided|||Week 14: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||10.00|-6.67|0.6010
72466176|NCT01475461|144455401|SUPERIORITY_OR_OTHER||LS Mean Difference|0.76|STANDARD_ERROR_OF_MEAN|0.449||0.0913|TWO_SIDED|80.0|0.18|1.34||P-value was 2-sided.|t-test, 2 sided|||Week 2: Treatment difference and 80 percent (%) confidence interval (CI) were based on least squares (LS) mean. A mixed model repeated measure (MMRM) analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||1.34|0.18|0.0913
72466177|NCT01475461|144455401|SUPERIORITY_OR_OTHER||LS Mean Difference|0.29|STANDARD_ERROR_OF_MEAN|0.461||0.5236|TWO_SIDED|80.0|-0.3|0.89||P-value was 2-sided.|t-test, 2 sided|||Week 2: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.89|-0.30|0.5236
72466178|NCT01475461|144455401|SUPERIORITY_OR_OTHER||LS Mean Difference|0.04|STANDARD_ERROR_OF_MEAN|0.447||0.9244|TWO_SIDED|80.0|-0.53|0.62||P-value was 2-sided.|t-test, 2 sided|||Week 2: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.62|-0.53|0.9244
72466179|NCT01475461|144455401|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|0.452||0.5066|TWO_SIDED|80.0|-0.28|0.88||P-value was 2-sided.|t-test, 2 sided|||Week 2: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.88|-0.28|0.5066
72466180|NCT01475461|144455401|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.449||0.8947|TWO_SIDED|80.0|-0.64|0.52||P-value was 2-sided.|t-test, 2 sided|||Week 2: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.52|-0.64|0.8947
72466181|NCT01475461|144455401|SUPERIORITY_OR_OTHER||LS Mean Difference|0.91|STANDARD_ERROR_OF_MEAN|0.478||0.0577|TWO_SIDED|80.0|0.3|1.52||P-value was 2-sided.|t-test, 2 sided|||Week 4: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||1.52|0.30|0.0577
72466182|NCT01475461|144455401|SUPERIORITY_OR_OTHER||LS Mean Difference|0.51|STANDARD_ERROR_OF_MEAN|0.49||0.3012|TWO_SIDED|80.0|-0.12|1.14||P-value was 2-sided.|t-test, 2 sided|||Week 4: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||1.14|-0.12|0.3012
72466183|NCT01475461|144455401|SUPERIORITY_OR_OTHER||LS Mean Difference|0.48|STANDARD_ERROR_OF_MEAN|0.476||0.3165|TWO_SIDED|80.0|-0.13|1.09||P-value was 2-sided.|t-test, 2 sided|||Week 4: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||1.09|-0.13|0.3165
72564432|NCT02310763|144660495|SUPERIORITY||Mean Difference (Net)|3.5||||0.0554|TWO_SIDED|95.0|-0.1|7.1||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC\<3.5 seconds||7.1|-0.1|0.0554
72564433|NCT02310763|144660495|SUPERIORITY||Mean Difference (Net)|1.6||||0.2027|TWO_SIDED|95.0|-0.9|4.0||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC\>=3.5 and \<= 8 seconds||4.0|-0.9|0.2027
72369834|NCT04881942|144250145|EQUIVALENCE|"Null Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is equal to 0.~Alternate Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is not equal to 0."|Mean Difference (Net)|89.44||||0.0184|TWO_SIDED|95.0|15.77|163.11|||ANCOVA||Mean value is sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham)|"Null Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is equal to 0.~Alternate Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is not equal to 0."||163.11|15.77|0.0184
72394506|NCT04847557|144295781|SUPERIORITY||Hazard Ratio (HR)|1.245|||||TWO_SIDED|95.0|0.633|2.452||||||||2.452|0.633|
72394507|NCT04847557|144295782|SUPERIORITY||Hazard Ratio (HR)|0.539|||||TWO_SIDED|95.0|0.342|0.85||||||||0.850|0.342|
72394508|NCT04847557|144295783|SUPERIORITY||Rate Ratio|0.72|||||TWO_SIDED|95.0|0.46|1.14||||||||1.14|0.46|
72503191|NCT03351244|144536983|OTHER||Hazard Ratio (HR)|1.116||||0.893|TWO_SIDED|95.0|0.225|5.531|||Regression, Cox|The model included the treatment effect as the only covariate and was stratified by country.||||5.531|0.225|0.8930
72394509|NCT04847557|144295784|SUPERIORITY||Rate Ratio|0.62|||||TWO_SIDED|95.0|0.37|1.05||||||||1.05|0.37|
72503192|NCT03351244|144536983|OTHER||Hazard Ratio (HR)|1.058||||0.936|TWO_SIDED|95.0|0.265|4.233|||Regression, Cox|The model included the treatment effect as the only covariate and was stratified by country.||||4.233|0.265|0.9360
72466184|NCT01475461|144455401|SUPERIORITY_OR_OTHER||LS Mean Difference|0.31|STANDARD_ERROR_OF_MEAN|0.481||0.5191|TWO_SIDED|80.0|-0.31|0.93||P-value was 2-sided.|t-test, 2 sided|||Week 4: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.93|-0.31|0.5191
72466185|NCT01475461|144455401|SUPERIORITY_OR_OTHER||LS Mean Difference|0.32|STANDARD_ERROR_OF_MEAN|0.479||0.5107|TWO_SIDED|80.0|-0.3|0.93||P-value was 2-sided.|t-test, 2 sided|||Week 4: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.93|-0.30|0.5107
72466186|NCT01475461|144455401|SUPERIORITY_OR_OTHER||LS Mean Difference|0.79|STANDARD_ERROR_OF_MEAN|0.488||0.1054|TWO_SIDED|80.0|0.17|1.42||P-value was 2-sided.|t-test, 2 sided|||Week 8: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||1.42|0.17|0.1054
72466187|NCT01475461|144455401|SUPERIORITY_OR_OTHER||LS Mean Difference|0.31|STANDARD_ERROR_OF_MEAN|0.502||0.5341|TWO_SIDED|80.0|-0.33|0.96||P-value was 2-sided.|t-test, 2 sided|||Week 8: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.96|-0.33|0.5341
72564434|NCT02310763|144660495|SUPERIORITY||Mean Difference (Net)|2.9||||0.0926|TWO_SIDED|95.0|-0.5|6.3||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC\>8 seconds||6.3|-0.5|0.0926
72564435|NCT02310763|144660496|SUPERIORITY||Mean Difference (Net)|2.0||||0.3597|TWO_SIDED|95.0|-2.4|6.3||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC\<3.5 seconds||6.3|-2.4|0.3597
72564436|NCT02310763|144660496|SUPERIORITY||Mean Difference (Net)|0.5||||0.7345|TWO_SIDED|95.0|-2.3|3.3||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC\>=3.5 and \<=8 seconds||3.3|-2.3|0.7345
72564437|NCT02310763|144660496|SUPERIORITY||Mean Difference (Net)|4.0||||0.032|TWO_SIDED|95.0|0.4|7.7||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC\>8 seconds||7.7|0.4|0.0320
72564438|NCT02310763|144660497|SUPERIORITY||Mean Difference (Net)|1.2||||0.3345|TWO_SIDED|95.0|-1.3|3.8||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC\<3.5 seconds||3.8|-1.3|0.3345
72564439|NCT02310763|144660497|SUPERIORITY||Mean Difference (Net)|-1.2||||0.14|TWO_SIDED|95.0|-2.9|0.4||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC\>=3.5 and \<= 8 seconds||0.4|-2.9|0.1400
72564440|NCT02310763|144660497|SUPERIORITY||Mean Difference (Net)|-0.9||||0.6764|TWO_SIDED|95.0|-5.4|3.6||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC\>8 seconds||3.6|-5.4|0.6764
72564441|NCT02310763|144660498|SUPERIORITY||Mean Difference (Net)|6.5||||0.097|TWO_SIDED|95.0|-1.2|14.2||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC\<3.5 seconds||14.2|-1.2|0.0970
72564442|NCT02310763|144660498|SUPERIORITY||Mean Difference (Net)|-0.3||||0.6919|TWO_SIDED|95.0|-1.9|1.3||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC\>=3.5 and \<=8 seconds||1.3|-1.9|0.6919
72564443|NCT02310763|144660498|SUPERIORITY||Mean Difference (Net)|-1.0||||0.6736|TWO_SIDED|95.0|-5.8|3.9||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC\>8 seconds||3.9|-5.8|0.6736
72564444|NCT02310763|144660499|SUPERIORITY||Mean Difference (Net)|0.0||||0.9582|TWO_SIDED|95.0|-1.5|1.5||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC\<3.5 seconds||1.5|-1.5|0.9582
72564445|NCT02310763|144660499|SUPERIORITY||Mean Difference (Net)|-0.1||||0.8629|TWO_SIDED|95.0|-1.8|1.5||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC\>=3.5 and \<= 8 seconds||1.5|-1.8|0.8629
72564446|NCT02310763|144660499|SUPERIORITY||Mean Difference (Net)|-0.9||||0.6746|TWO_SIDED|95.0|-5.5|3.7||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC\>8 seconds||3.7|-5.5|0.6746
72564447|NCT02310763|144660500|SUPERIORITY||Mean Difference (Net)|-5.8||||0.7483|TWO_SIDED|95.0|-42.4|30.7||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC\<3.5 seconds||30.7|-42.4|0.7483
72564448|NCT02310763|144660500|SUPERIORITY||Mean Difference (Net)|-1.3||||0.9053|TWO_SIDED|95.0|-23.9|21.2||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC\>=3.5 and \<=8 seconds||21.2|-23.9|0.9053
72564449|NCT02310763|144660500|SUPERIORITY||Mean Difference (Net)|13.1||||0.6896|TWO_SIDED|95.0|-53.4|79.7||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC\>8 seconds||79.7|-53.4|0.6896
72564450|NCT02310763|144660501|SUPERIORITY||Mean Difference (Net)|-3.7||||0.8117|TWO_SIDED|95.0|-34.8|27.5||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC\<3.5 seconds||27.5|-34.8|0.8117
72564451|NCT02310763|144660501|SUPERIORITY||Mean Difference (Net)|7.3||||0.6018|TWO_SIDED|95.0|-20.6|35.2||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC\>=3.5 and \<=8 seconds||35.2|-20.6|0.6018
72503193|NCT03351244|144536985|OTHER||Hazard Ratio (HR)|0.788||||0.6362|TWO_SIDED|95.0|0.293|2.118|||Regression, Cox|The model included the treatment effect as the only covariate and was stratified by country.||||2.118|0.293|0.6362
72503194|NCT03351244|144536985|OTHER||Hazard Ratio (HR)|0.612||||0.3782|TWO_SIDED|95.0|0.205|1.826|||Regression, Cox|The model included the treatment effect as the only covariate and was stratified by country.||||1.826|0.205|0.3782
72503195|NCT03351244|144536985|OTHER||Hazard Ratio (HR)|0.703||||0.4253|TWO_SIDED|95.0|0.296|1.671|||Regression, Cox|The model included the treatment effect as the only covariate and was stratified by country.||||1.671|0.296|0.4253
72503196|NCT00892437|144536986|NON_INFERIORITY_OR_EQUIVALENCE|Null hypothesis: the response rate in the ATV+COBI+FTC/TDF group was at least 12% worse than in the ATV+RTV+FTC/TDF group; alternative hypothesis: the response rate in the ATV+COBI+FTC/TDF group was less than 12% worse than that in the ATV+RTV+FTC/TDF group. ATV+COBI+FTC/TDF was noninferior if the lower bound of the 2-sided 95% confidence interval (CI) of the baseline HIV-1 RNA stratum-weighted difference (COBI group - RTV group) in the response rate at Week 24 was greater than -12%.|Difference in percentages|-7.4|||||TWO_SIDED|95.0|-24.6|9.9|||||Difference in percentages of success and its 95% confidence interval (CI) were calculated based on baseline HIV-1 RNA stratum-adjusted Mantel-Haenszel (MH) proportion.|A total planned sample size of 75 subjects had 26% power to evaluate noninferiority with respect to the response rate of HIV-1 RNA \< 50 copies/mL at Week 24 if a response rate of 84% for both arms and a noninferiority margin of 0.12 were assumed.||9.9|-24.6|
72503197|NCT00892437|144536987|NON_INFERIORITY_OR_EQUIVALENCE|The null hypothesis was that the response rate in the ATV+COBI+FTC/TDF group was at least 12% worse than the response rate in ATV+RTV+FTC/TDF group; the alternative hypothesis was that the response rate in the ATV+COBI+FTC/TDF group was less than 12% worse than that in the ATV+RTV+FTC/TDF group.|Difference in percentages|-8.3|||||TWO_SIDED|95.0|-25.9|9.4|||||Difference in percentages of success and its 95% CI were calculated based on baseline HIV-1 RNA stratum-adjusted MH proportion.|||9.4|-25.9|
72503198|NCT00892437|144536988|SUPERIORITY_OR_OTHER||Difference in least squares mean (LSM)|-0.02||||0.87|TWO_SIDED|95.0|-0.25|0.22||P-values were obtained from an ANOVA model including baseline HIV-1 RNA category in the model.|ANOVA||The difference in least squares mean (LSM) and its 95% CI were computed using ANOVA model, including baseline HIV-1 RNA category in the model.|||0.22|-0.25|0.87
72503199|NCT00892437|144536989|SUPERIORITY_OR_OTHER||Difference in LSM|-0.03||||0.82|TWO_SIDED|95.0|-0.3|0.23||P-values were obtained from an ANOVA model including baseline HIV-1 RNA category in the model.|ANOVA||The difference in LSM and its 95% CI were computed using ANOVA model, including baseline HIV-1 RNA category in the model.|||0.23|-0.30|0.82
72503200|NCT00892437|144536990|SUPERIORITY_OR_OTHER||Difference in LSM|10.0||||0.78|TWO_SIDED|95.0|-63.0|84.0||P-values were obtained from an ANOVA model including baseline HIV-1 RNA category in the model.|ANOVA||The difference in LSM and its 95% CI were computed using ANOVA model, including baseline HIV-1 RNA category in the model.|||84|-63|0.78
72503201|NCT00892437|144536991|SUPERIORITY_OR_OTHER||Difference in LSM|47.0||||0.29|TWO_SIDED|95.0|-41.0|134.0||P-values were obtained from an ANOVA model including baseline HIV-1 RNA category in the model.|ANOVA||The difference in LSM and its 95% CI were computed using ANOVA model, including baseline HIV-1 RNA category in the model.|||134|-41|0.29
72503202|NCT03215277|144537007|SUPERIORITY||Mean Posterior Difference|0.23|||||TWO_SIDED|95.0|-0.14|0.6|||Regression, Linear|||Results were based on a complete case (ie, data as observed) Bayesian linear model with the change from Baseline in ASDAS as the independent variable. Treatment was included as a predictor in the model and Baseline ASDAS as a covariate. The mean posterior difference and 95% credible interval were presented for the BKZ vs CZP comparison.||0.60|-0.14|
72564452|NCT02310763|144660501|SUPERIORITY||Mean Difference (Net)|16.3||||0.7152|TWO_SIDED|95.0|-73.4|106.0||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC\>8 seconds||106.0|-73.4|0.7152
72564453|NCT02310763|144660502|SUPERIORITY||Mean Difference (Net)|7.0||||0.719|TWO_SIDED|95.0|-32.1|46.1||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC\<3.5 seconds||46.1|-32.1|0.7190
72503203|NCT03215277|144537007|SUPERIORITY||PR[Diff > 0%](%)|88.4|||||TWO_SIDED||||||Regression, Linear|||Results were based on a complete case (ie, data as observed) Bayesian linear model with the change from Baseline in ASDAS as the independent variable. Treatment was included as a predictor in the model and Baseline ASDAS as a covariate. Pr\[Diff\>0%\](%) refers to the probability that the mean change from Baseline in ASDAS in the BKZ group was greater than the mean change from Baseline in ASDAS in the CZP group.||||
72564454|NCT02310763|144660502|SUPERIORITY||Mean Difference (Net)|-15.8||||0.4634|TWO_SIDED|95.0|-58.9|27.3||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC\>=3.5 and \<=8 seconds||27.3|-58.9|0.4634
72370691|NCT00488683|144251642|SUPERIORITY_OR_OTHER||R-square|0.13||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration at 12 months of age for the serogroup Y||||
72503204|NCT01882725|144537019|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||t-test, 1 sided|||||||<0.05
72503205|NCT01882725|144537020|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||t-test, 2 sided|||||||<0.01
72503206|NCT01238120|144537023|SUPERIORITY|||||||0.9168|||||||ANCOVA|||||||0.9168
72503207|NCT01238120|144537024|SUPERIORITY|||||||0.6536|||||||ANCOVA|||||||0.6536
72503208|NCT02498652|144537062|NON_INFERIORITY_OR_EQUIVALENCE|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|103.0|||||TWO_SIDED|90.0|90.7|117.0|||Mixed Models Analysis|Fixed effect for treatment and random effects for subjects.||||117|90.7|
72564455|NCT02310763|144660502|SUPERIORITY||Mean Difference (Net)|3.9||||0.94|TWO_SIDED|95.0|-100.7|108.5||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC\>8 seconds||108.5|-100.7|0.9400
72564456|NCT02310763|144660506|SUPERIORITY||Mean Difference (Net)|2.945||||0.0087|TWO_SIDED|95.0|0.7597|5.1309||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Week 17||5.1309|0.7597|0.0087
72564457|NCT02310763|144660506|SUPERIORITY||Mean Difference (Net)|2.918||||0.0536|TWO_SIDED|95.0|-0.0461|5.8811||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Week 33||5.8811|-0.0461|0.0536
72503209|NCT02498652|144537062|NON_INFERIORITY_OR_EQUIVALENCE|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|92.6|||||TWO_SIDED|90.0|78.1|110.0|||Mixed Models Analysis|Fixed effect for treatment and random effects for subjects.||||110|78.1|
72503210|NCT02498652|144537062|NON_INFERIORITY_OR_EQUIVALENCE|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|102.0|||||TWO_SIDED|90.0|85.7|120.0|||Mixed Models Analysis|Fixed effect for treatment and random effects for subjects. GLMSRs are back-transformed to the original scale.||||120|85.7|
72503211|NCT02498652|144537062|NON_INFERIORITY_OR_EQUIVALENCE|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|88.9|||||TWO_SIDED|90.0|78.4|101.0|||Mixed Models Analysis|Fixed effect for treatment and random effects for subjects. GLMSRs are back-transformed to the original scale.||||101|78.4|
72503212|NCT02498652|144537062|NON_INFERIORITY_OR_EQUIVALENCE|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|100.0|||||TWO_SIDED|90.0|87.7|114.0|||Mixed Models Analysis|Fixed effect for treatment and random effects for subjects. GLMSRs are back-transformed to the original scale||||114|87.7|
72503213|NCT02498652|144537062|NON_INFERIORITY_OR_EQUIVALENCE|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|101.0|||||TWO_SIDED|90.0|85.5|119.0|||Mixed Models Analysis|Fixed effect for treatment and random effects for subjects. GLMSRs are back-transformed to the original scale.||||119|85.5|
72503214|NCT02498652|144537065|NON_INFERIORITY_OR_EQUIVALENCE|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|100.0|||||TWO_SIDED|90.0|94.3|107.0|||Mixed Models Analysis|Fixed effect for treatment and random effects for subjects. GLMSRs are back-transformed to the original scale.||||107|94.3|
72503215|NCT02498652|144537065|NON_INFERIORITY_OR_EQUIVALENCE|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|98.0|||||TWO_SIDED|90.0|90.4|106.0|||Mixed Models Analysis|Fixed effect for treatment and random effects for subjects. GLMSRs are back-transformed to the original scale.||||106|90.4|
72503216|NCT02498652|144537065|NON_INFERIORITY_OR_EQUIVALENCE|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|104.0|||||TWO_SIDED|90.0|94.5|114.0|||Mixed Models Analysis|Fixed effect for treatment and random effects for subjects. GLMSRs are back-transformed to the original scale.||||114|94.5|
72621590|NCT02732145|144773204|SUPERIORITY|Question: Is there a difference in the incidence of the finding of mononuclear inflammatory infiltrates in vulvar specimens from patients with vulvodynia depending on the duration of vulvar discomfort for less or more than 24 months?||||||0.0032|||||||Chi-squared|||Parameter: The difference in the incidence of the histopathological finding of mononuclear inflammatory infiltrates in vulvar specimens from patients with vulvodynia depending on the duration of vulvar discomfort.||||0.0032
72621591|NCT02732145|144773204|SUPERIORITY|Question: Is there a difference in the incidence of the finding of collagen fibers in vulvar specimens from patients with vulvodynia depending on the duration of vulvar discomfort for less or more than 24 months?||||||0.1067|||||||Chi-squared|||Parameter: The difference in the incidence of the histopathological finding of collagen fibers in vulvar specimens from patients with vulvodynia depending on the duration of vulvar discomfort.||||0.1067
72621592|NCT02732145|144773204|SUPERIORITY|Question: Is there a difference in the incidence of inflammatory cells in vulvar specimens from patients with vulvodynia depending on the duration of vulvar discomfort for less or more than 24 months?||||||0.8672|||||||Chi-squared|||Parameter: The difference in the incidence of the histopathological finding of hyalinization in vulvar specimens from patients with vulvodynia depending on the duration of vulvar discomfort.||||0.8672
72621593|NCT02732145|144773204|SUPERIORITY|Question: Is there a difference in the incidence of blood vessels in vulvar specimens from patients with vulvodynia depending on the duration of vulvar discomfort for less or more than 24 months?||||||0.0219|||||||Chi-squared|||Parameter: The difference in the incidence of the histopathological finding of blood vessels in vulvar specimens from patients with vulvodynia depending on the duration of vulvar discomfort.||||0.0219
72621594|NCT02732145|144773204|SUPERIORITY|Question: Is there a difference in the incidence of sebaceous glands in vulvar specimens from patients with vulvodynia depending on the duration of vulvar discomfort for less or more than 24 months?||||||0.8213|||||||Chi-squared|||Parameter: The difference in the incidence of the histopathological finding of sebaceous glands in vulvar specimens from patients with vulvodynia depending on the duration of vulvar discomfort.||||0.8213
72621595|NCT02732145|144773204|SUPERIORITY|Question: Is there a difference in the incidence of the finding of nerve fibers in vulvar specimens from patients with vulvodynia depending on the duration of vulvar discomfort for less or more than 24 months?||||||0.0613|||||||Chi-squared|||Parameter: The difference in the incidence of the histopathological finding of nerve fibers in vulvar specimens from patients with vulvodynia depending on the duration of vulvar discomfort.||||0.0613
72621596|NCT01837550|144773207|NON_INFERIORITY_OR_EQUIVALENCE|To ensure a between-group effect of 80% at the 5% significance level it was estimated that 60 participants need to be included in the study. An effect size of Cohen's d=0.80 was expected. The expected standardized mean difference on the HHIE formed the basis for the obtained power.||||||0.685|||||||Mixed Models Analysis|||||||0.685
72503217|NCT02498652|144537065|NON_INFERIORITY_OR_EQUIVALENCE|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|92.0|||||TWO_SIDED|90.0|86.7|97.7|||Mixed Models Analysis|Fixed effect for treatment and random effects for subjects. GLMSRs are back-transformed to the original scale.||||97.7|86.7|
72503218|NCT02498652|144537065|NON_INFERIORITY|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|98.9|||||TWO_SIDED|90.0|91.0|107.0|||Mixed Models Analysis|Fixed effect for treatment and random effects for subjects. GLMSRs are back-transformed to the original scale.||||107|91.0|
72503219|NCT02498652|144537065|NON_INFERIORITY_OR_EQUIVALENCE|Informal BE assessment using the conventional BE limits of 80% to 125%|Geometric Least Squares Mean Ratio (%)|97.5|||||TWO_SIDED|90.0|92.8|102.0|||Mixed Models Analysis|Fixed effect for treatment and random effects for subjects. GLMSRs are back-transformed to the original scale.||||102|92.8|
72503220|NCT04207710|144537071|SUPERIORITY|||||||0.317||||||A priori threshold for significance was p\<0.05.|Friedman|||Comparison of incidence of positive growth in samples obtained following application of ChloraPrep vs. ChloraPrep followed by Gebauer's Ethyl Chloride.||||0.317
72503221|NCT04207710|144537071|SUPERIORITY|||||||0.317||||||A priori threshold was p\<0.05|Friedman|||Comparison of incidence of positive growth in samples obtained following application of ChloraPrep vs. ChloraPrep followed by Gebauer's Ethyl Chloride.||||0.317
72394510|NCT02310568|144295786|SUPERIORITY_OR_OTHER||Least Square (LS) Mean Difference|0.6|STANDARD_ERROR_OF_MEAN|2.01||0.784|TWO_SIDED|90.0|-2.8|3.9|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - Placebo). Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1.||3.9|-2.8|0.784
72466188|NCT01475461|144455401|SUPERIORITY_OR_OTHER||LS Mean Difference|0.53|STANDARD_ERROR_OF_MEAN|0.487||0.2782|TWO_SIDED|80.0|-0.1|1.15||P-value was 2-sided.|t-test, 2 sided|||Week 8: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||1.15|-0.10|0.2782
72564458|NCT02310763|144660506|SUPERIORITY||Mean Difference (Net)|4.087||||0.0298|TWO_SIDED|95.0|0.4069|7.7677||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Week 49||7.7677|0.4069|0.0298
72466189|NCT01475461|144455401|SUPERIORITY_OR_OTHER||LS Mean Difference|0.31|STANDARD_ERROR_OF_MEAN|0.492||0.5331|TWO_SIDED|80.0|-0.32|0.94||P-value was 2-sided.|t-test, 2 sided|||Week 8: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.94|-0.32|0.5331
72466190|NCT01475461|144455401|SUPERIORITY_OR_OTHER||LS Mean Difference|0.06|STANDARD_ERROR_OF_MEAN|0.489||0.907|TWO_SIDED|80.0|-0.57|0.68||P-value was 2-sided.|t-test, 2 sided|||Week 8: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.68|-0.57|0.9070
72564459|NCT02310763|144660507|SUPERIORITY||Mean Difference (Net)|1.575||||0.0684|TWO_SIDED|95.0|-0.1213|3.2715||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Week 17||3.2715|-0.1213|0.0684
72564460|NCT02310763|144660507|SUPERIORITY||Mean Difference (Net)|2.612||||0.0376|TWO_SIDED|95.0|0.1521|5.0711||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Week 33||5.0711|0.1521|0.0376
72621597|NCT04191733|144773217|NON_INFERIORITY|The non-inferiority analysis was demonstrated when the 1-sided upper 95% confidence interval (CI) limit was less than 1.25.|||||<|0.0001||||||one-sided p-value|t-test, 1 sided|||||||<0.0001
72621598|NCT04191733|144773218|NON_INFERIORITY|1-sided test with 5% alpha was used to demonstrate non-inferiority with greater than 99% power. The non-inferiority margin was 3.75 minutes.||||||0.1004|||||||t-test, 1 sided|||A gatekeeping strategy was used to control family-wise type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially in the order the endpoints are reported. The testing sequence continued only when previous endpoint was statistically significant with a 1-sided alpha of 0.05.||||0.1004
72394511|NCT02310568|144295786|SUPERIORITY_OR_OTHER||LS Mean Difference|2.6|STANDARD_ERROR_OF_MEAN|1.94||0.184|TWO_SIDED|90.0|-0.6|5.8|||Mixed-Effects Model Repeated Measure|||(PF-06372865 2.5 mg - Placebo). Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1.||5.8|-0.6|0.184
72466191|NCT01475461|144455401|SUPERIORITY_OR_OTHER||LS Mean Difference|0.69|STANDARD_ERROR_OF_MEAN|0.512||0.1757|TWO_SIDED|80.0|0.04|1.35||P-value was 2-sided.|t-test, 2 sided|||Week 12: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||1.35|0.04|0.1757
72466192|NCT01475461|144455401|SUPERIORITY_OR_OTHER||LS Mean Difference|0.44|STANDARD_ERROR_OF_MEAN|0.527||0.4083|TWO_SIDED|80.0|-0.24|1.11||P-value was 2-sided.|t-test, 2 sided|||Week 12: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||1.11|-0.24|0.4083
72503222|NCT04207710|144537071|SUPERIORITY|||||||0.317||||||A priori threshold was p\<0.05|Friedman|||Comparison of incidence of positive growth in samples obtained following application of ChloraPrep vs. ChloraPrep followed by Gebauer's Pain Ease.||||0.317
72503223|NCT04207710|144537071|SUPERIORITY|||||||0.317||||||A priori threshold was p\<0.05|Friedman|||Comparison of incidence of positive growth in samples obtained following application of ChloraPrep vs. ChloraPrep followed by Gebauer's Pain Ease.||||0.317
72503224|NCT00095303|144537081|SUPERIORITY_OR_OTHER||slope of linear trajectory of drug use|0.05||||0.27|TWO_SIDED|95.0|-0.04|0.14|||Mixed Models Analysis||The parameter estimated is the regression coefficient on the interaction of the BSFT treatment assignment and the linear time trend.|Null Hypothesis: BSFT will be significantly more effective than TAU in reducing adolescent drug abuse, defined as the percentage of drug use days in 28-day periods. The outcome variable is the percentage of days of drug use within a 28-day period. This variable constructed from the Timeline-Follow-back instrument and measured as the sum of the number of days with positive use in 28-day increments. Hypothesis tested using hierarchical linear models.||.14|-.04|.27
72503225|NCT00095303|144537083|SUPERIORITY_OR_OTHER||Slope|-0.1||||0.26|TWO_SIDED|95.0|-0.28|0.08|||Mixed Models Analysis||The parameter estimated is the regression coefficient on the interaction of BSFT treatment assignment and the linear time trend.|Null hypothesis: It is hypothesized that BSFT will be significantly more effective than TAU in decreasing adolescent externalizing problem behaviors||0.08|-0.28|.26
72564461|NCT02310763|144660507|SUPERIORITY||Mean Difference (Net)|3.208||||0.0411|TWO_SIDED|95.0|0.1318|6.2844||The significance level is 0.05|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Week 49||6.2844|0.1318|0.0411
72564462|NCT03877926|144660525|EQUIVALENCE|The 95% CIs for the Day 64 TNA NF50 GMT ratios between AV7909 Lot 1 and Lot 2 had to be within 0.5 to 2.0 equivalence margin.|Ratio|1.01|||||TWO_SIDED|95.0|0.93|1.1||||||||1.10|0.93|
72564463|NCT03877926|144660525|EQUIVALENCE|The 95% CIs for the Day 64 TNA NF50 GMT ratios between AV7909 Lot 1 and Lot 3 had to be within 0.5 to 2.0 equivalence margin.|Ratio|1.05|||||TWO_SIDED|95.0|0.96|1.14||||||||1.14|0.96|
72564464|NCT03877926|144660525|EQUIVALENCE|The 95% CIs for the Day 64 TNA NF50 GMT ratios between AV7909 Lot 2 and Lot 3 had to be within 0.5 to 2.0 equivalence margin.|Ratio|1.04|||||TWO_SIDED|95.0|0.95|1.13||||||||1.13|0.95|
72621599|NCT02349477|144773237|SUPERIORITY||Odds Ratio (OR)|3.9||||0.028|TWO_SIDED||||||Regression, Logistic|This is the p-value output from the logistic regression model where medication group predicted the discrete variable for no heavy drinking days.||This analysis compares between Gabapentin and Placebo, the number of individuals who reported no heavy drinking days throughout the entire trial, corrected for %dCDT.||||.028
72621600|NCT02349477|144773238|SUPERIORITY||Odds Ratio (OR)|4.9||||0.053|TWO_SIDED||||||Regression, Logistic|This is the p-value output from the logistic regression model where medication group predicted the discrete variable for abstinence.||This analysis compares between Gabapentin and Placebo, the number of individuals who reported no drinking days (abstinence) throughout the entire trial, corrected for %dCDT.||||.053
72621601|NCT02349477|144773239|SUPERIORITY|||||||0.001|||||||Chi-squared|||For the High AWS group, a chi squared analysis compares the number of individuals with no heavy drinking days between medication groups.||||.001
72621602|NCT02349477|144773239|SUPERIORITY|||||||0.67|||||||Chi-squared|||For the Low AWS group, a chi squared analysis compares the number of individuals with no heavy drinking days between medication groups.||||.67
72621603|NCT01714063|144773240|OTHER|We used a paired T-test for statistical analysis to compare the filter dose. Using the 1% significance level and assuming a between-subject standard deviation of 60 lg (27%) for the difference between coordinated and doses, 32 subjects are sufficient to detect a 45 lg (20%) difference with 95% confidence.uncoordinated filter|||||<|0.001|||||||paired t-test|||||||<0.001
72621604|NCT02633527|144773255|SUPERIORITY||Mean Difference (Final Values)|-6.2||||0.0899|TWO_SIDED|95.0|-13.4|1.0|||ANOVA|||||1.0|-13.4|0.0899
72621605|NCT02633527|144773255|SUPERIORITY||Mean Difference (Final Values)|-7.9||||0.031|TWO_SIDED|95.0|-15.1|-0.7|||ANOVA|||||-0.7|-15.1|0.0310
72621606|NCT02633527|144773255|SUPERIORITY||Mean Difference (Final Values)|-8.1||||0.0268|TWO_SIDED|95.0|-15.3|-0.9|||ANOVA|||||-0.9|-15.3|0.0268
72621607|NCT02633527|144773255|SUPERIORITY||Mean Difference (Final Values)|-8.5||||0.0209|TWO_SIDED|95.0|-15.8|-1.3|||ANOVA|||||-1.3|-15.8|0.0209
72621608|NCT02633527|144773256|SUPERIORITY||Mean Difference (Final Values)|-0.4||||0.1305|TWO_SIDED|95.0|-1.0|0.1|||ANOVA|||||0.1|-1.0|0.1305
72621609|NCT02633527|144773256|SUPERIORITY||Mean Difference (Final Values)|-0.4||||0.1376|TWO_SIDED|95.0|-1.0|0.1|||ANOVA|||||0.1|-1.0|0.1376
72621610|NCT02633527|144773256|SUPERIORITY||Mean Difference (Final Values)|-0.8||||0.009|TWO_SIDED|95.0|-1.3|-0.2|||ANOVA|||||-0.2|-1.3|0.0090
72621611|NCT02633527|144773256|SUPERIORITY||Mean Difference (Final Values)|-0.6||||0.0546|TWO_SIDED|95.0|-1.1|0.0|||ANOVA|||||0.0|-1.1|0.0546
72621612|NCT02633527|144773257|SUPERIORITY||Mean Difference (Final Values)|-0.6||||0.0708|TWO_SIDED|95.0|-1.3|0.1|||ANCOVA|||||0.1|-1.3|0.0708
72621613|NCT02633527|144773257|SUPERIORITY||Mean Difference (Final Values)|-0.8||||0.0309|TWO_SIDED|95.0|-1.4|-0.1|||ANCOVA|||||-0.1|-1.4|0.0309
72621614|NCT02633527|144773257|SUPERIORITY||Mean Difference (Final Values)|-0.8||||0.0148|TWO_SIDED|95.0|-1.5|-0.2|||ANCOVA|||||-0.2|-1.5|0.0148
72621615|NCT02633527|144773257|SUPERIORITY||Mean Difference (Final Values)|-0.9||||0.0136|TWO_SIDED|95.0|-1.6|-0.2|||ANCOVA|||||-0.2|-1.6|0.0136
72621616|NCT04135443|144773282|SUPERIORITY||Odds Ratio (OR)|1.027||||0.94|TWO_SIDED|95.0|0.511|2.063|||Regression, Logistic|||||2.063|0.511|0.94
72621617|NCT04135443|144773284|SUPERIORITY||Slope|0.064||||0.455|TWO_SIDED|||||Threshold set to p\<0.05.|Regression, Linear|See analysis plan for covariates screened into model.||||||0.455
72621618|NCT04135443|144773285|SUPERIORITY||Slope|0.026||||0.702|TWO_SIDED|||||Threshold set to p\<0.05.|Regression, Linear|See analysis plan for covariates screened into model.||||||0.702
72621619|NCT04135443|144773286|SUPERIORITY||Slope|0.049||||0.375|TWO_SIDED|||||Threshold set to p\<0.05.|Regression, Linear|See analysis plan for covariates screened into model.||||||0.375
72621620|NCT04135443|144773287|SUPERIORITY||Slope|0.076||||0.313|TWO_SIDED|||||Threshold set to p\<0.05.|Regression, Linear|See analysis plan for covariates screened into model.||||||0.313
72621621|NCT04135443|144773288|SUPERIORITY||Slope|-0.01||||0.89|TWO_SIDED|||||Threshold set to p\<0.05.|Regression, Linear|See analysis plan for covariates screened into model.||||||0.890
72621622|NCT03856177|144773308|OTHER|||||||0.071|||||||t-test, 2 sided|||||||.071
72621623|NCT03460704|144773311|SUPERIORITY||LS Mean rate ratio|1.004||||0.97889|TWO_SIDED|95.0|0.747|1.349|||negative binomial model|||The number of NCFB pulmonary exacerbations was compared between treatment groups using a negative binomial model including treatment, country, and baseline use of stable concomitant therapy with oral macrolides as fixed effects and log-exposure time on treatment as an offset.||1.349|0.747|0.97889
72621624|NCT01767857|144773329|SUPERIORITY|||||||0.613|||||||Log Rank|||||||0.613
72621625|NCT01767857|144773330|SUPERIORITY|||||||0.011|||||||ANCOVA|||||||0.011
72621626|NCT01767857|144773331|SUPERIORITY|||||||0.541|||||||ANCOVA|||Statistical Analysis for Global Health Status/Qol||||0.541
72621627|NCT01767857|144773331|SUPERIORITY|||||||0.56|||||||ANCOVA|||Statistical Analysis for Pain||||0.560
72621628|NCT01767857|144773331|SUPERIORITY|||||||0.603|||||||ANCOVA|||Statistical Analysis for Fatigue||||0.603
72621629|NCT01767857|144773331|SUPERIORITY|||||||0.485|||||||ANCOVA|||Statistical Analysis for Appetite Loss||||0.485
72621630|NCT01767857|144773332|SUPERIORITY|||||||0.21|||||||ANCOVA|||||||0.210
72621631|NCT01767857|144773333|SUPERIORITY|||||||0.768|||||||Log Rank|||||||0.768
72621632|NCT03657407|144773359|SUPERIORITY||Mean Difference (Final Values)|-0.65||||0.17|TWO_SIDED|95.0|-0.71|2.0|||t-test, 1 sided|||Null hypothesis that Belladonna \& Opium not superior to Placebo||2.0|-0.71|0.17
72621633|NCT03657407|144773360|SUPERIORITY||Mean Difference (Final Values)|-2.02||||0.29|TWO_SIDED|95.0|-5.4|9.5|||t-test, 1 sided|||Null hypothesis that Belladonna \& Opium not superior to Placebo||9.5|-5.4|0.29
72621634|NCT03657407|144773361|SUPERIORITY||Median Difference (Final Values)|-19.31||||0.05|TWO_SIDED|95.0|-43.1|4.5|||t-test, 1 sided|||Null hypothesis that Belladonna \& Opium not superior to Placebo||4.5|-43.1|0.05
72621635|NCT03657407|144773362|SUPERIORITY||Mean Difference (Final Values)|0.85||||0.42|TWO_SIDED|95.0|0.42|1.7|||t-test, 1 sided|||Null hypothesis that Belladonna \& Opium not superior to Placebo||1.7|0.42|0.42
72621636|NCT02628145|144773363|OTHER||Mean Difference (Final Values)|-0.01||||0.91|TWO_SIDED||||||Mixed Models Analysis|||||||0.91
72621637|NCT02628145|144773364|SUPERIORITY|||||||0.88|||||||Chi-squared|||||||0.88
72621638|NCT02628145|144773365|SUPERIORITY|||||||0.068|||||||Fisher Exact|||||||0.068
72621639|NCT02628145|144773366|SUPERIORITY|||||||0.48|||||||Mixed Models Analysis|||||||0.48
72503226|NCT00095303|144537099|SUPERIORITY_OR_OTHER||Rate Ratio|0.94||||0.21|TWO_SIDED|95.0|0.82|1.09|||GEE|||Null Hypothesis: BSFT will be significantly more effective than TAU in the rates of drug use, defined as the percentage of drug use days in last 90 days. The primary hypothesis will be evaluated in terms of % of days of drug use in the last 90 days, assessed by the timeline follow-back. The general analytic approach will use generalized estimating equation (GEE) with negative binomial distribution comparing the BSFT and TAU participants||1.09|.82|.21
72503227|NCT00095303|144537101|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.42|||<|0.006|TWO_SIDED|95.0|-0.71|-0.12|||GEE|||Null hypothesis: It is hypothesized that BSFT will be significantly more effective than TAU in the level of externalizing problem behaviors||-.12|-.71|<.006
72504842|NCT00035815|144540602|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.04||||0.415|TWO_SIDED|95.0|0.77|1.4|||Regression, Cox|||Patients who elected to proceed to tracheostomy were assessed on the day of their procedure. Subjects who continuously utilized NIPPV for greater than 10 days were assessed as being ventilator-dependent on the first day they began continuous NIPPV. Survival between groups was compared using the Cox-proportional Hazards model.||1.4|0.77|0.415
72621640|NCT02628145|144773367|SUPERIORITY|||||||0.52|||||||Mixed Models Analysis|||||||0.52
72621641|NCT02628145|144773368|SUPERIORITY||||||>|0.05|||||||Mixed Models Analysis|||||||>0.05
72621642|NCT02628145|144773369|SUPERIORITY||||||>|0.05|||||||Mixed Models Analysis|||||||>0.05
72621643|NCT02628145|144773370|SUPERIORITY||||||>|0.05|||||||Mixed Models Analysis|||||||>0.05
72621644|NCT02628145|144773371|SUPERIORITY||||||>|0.05|||||||Mixed Models Analysis|||||||>0.05
72621645|NCT02628145|144773373|SUPERIORITY|||||||0.04|||||||Mixed Models Analysis|||||||0.04
72621646|NCT00420056|144773379|SUPERIORITY_OR_OTHER|||||||0.4854|TWO_SIDED||||||Regression, Linear|||||||0.4854
72621647|NCT00420056|144773380|SUPERIORITY_OR_OTHER|||||||0.709|TWO_SIDED||||||Regression, Linear|||||||0.7090
72621648|NCT00420056|144773383|SUPERIORITY_OR_OTHER||Kappa|0.0638|||||TWO_SIDED|95.0|-0.0449|0.1726||||||FLT-PET response versus Objective response||0.1726|-0.0449|
72621649|NCT00420056|144773383|SUPERIORITY_OR_OTHER||Kappa|0.1864|||||TWO_SIDED|95.0|-0.2316|0.6045||||||FDG-PET response versus Objective response||0.6045|-0.2316|
72621650|NCT00420056|144773397|SUPERIORITY_OR_OTHER|||||||0.5954|TWO_SIDED||||||Regression, Linear|||Concentration versus Ki-67||||0.5954
72621651|NCT00420056|144773397|SUPERIORITY_OR_OTHER|||||||0.1286|TWO_SIDED||||||Regression, Linear|||Concentration versus Cyclin D1||||0.1286
72621652|NCT00420056|144773397|SUPERIORITY_OR_OTHER|||||||0.0956|TWO_SIDED||||||Regression, Linear|||Concentration versus phospho-Rb||||0.0956
72621653|NCT00420056|144773397|SUPERIORITY_OR_OTHER|||||||0.28|TWO_SIDED||||||Regression, Linear|||Concentration versus FLT-PET SUVmax||||0.2800
72621654|NCT00420056|144773397|SUPERIORITY_OR_OTHER|||||||0.4921|TWO_SIDED||||||Regression, Linear|||Concentration versus FDG-PET SUVmax||||0.4921
72621655|NCT00907088|144773406|SUPERIORITY_OR_OTHER|||||||0.42|||||||Chi-squared|||||||0.42
72621656|NCT02301793|144773409|OTHER||Odds Ratio (OR)|1.0||||0.05|TWO_SIDED|95.0||||The reported p-values were calculated by reiterating the multiple outputation procedure 1000 times, we estimated the odds ratios (ORs) and their 95% confidence intervals conditional on the floor and nurse.|Regression, Logistic|||The hypothesis comparing the different educational arms was evaluated using an intention-to-treat approach (i.e. all nurses were included regardless of training completion) accounting for clustering in the data and comparing rates of VTE prophylaxis dose non-administration at baseline and during the Post-Education period. Two per-protocol sensitivity analyses were performed. They compared the Baseline vs. Post-Education periods for nurses who received training and nurses who completed training.||||0.05
72621657|NCT02301793|144773413|OTHER||Odds Ratio (OR)|1.0||||0.05|TWO_SIDED|95.0||||The reported p-values were calculated by reiterating the multiple outputation procedure 1000 times, we estimated the odds ratios (ORs) and their 95% confidence intervals conditional on the floor and nurse.|Regression, Logistic|||The hypothesis comparing the different educational arms was evaluated using an intention-to-treat approach (i.e. all nurses were included regardless of training completion) accounting for clustering in the data and comparing rates of VTE prophylaxis dose non-administration at baseline and during the Post-Education period. Two per-protocol sensitivity analyses were performed. They compared the Baseline vs. Post-Education periods for nurses who received training and nurses who completed training.||||0.05
72621658|NCT01500135|144773445|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.62|STANDARD_ERROR_OF_MEAN|0.72||0.276|TWO_SIDED|95.0|0.68|3.88||Logistic regression model with treatment, type of surgery (Peripheral Arterial Disease, Arterio Venous Graft) and current use of Clopidogrel or other similar anti-platelet drugs (yes/no) as covariates.|Regression, Logistic|||||3.88|0.68|0.276
72621659|NCT01500135|144773446|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.85|STANDARD_ERROR_OF_MEAN|0.33||0.684|TWO_SIDED|95.0|0.4|1.82||Logistic regression model with treatment, type of surgery (Peripheral Arterial Disease, Arterio Venous Graft) and current use of Clopidogrel or other similar anti-platelet drugs (yes/no) as covariates.|Regression, Logistic|||||1.82|0.40|0.684
72621660|NCT01500135|144773447|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.14|STANDARD_ERROR_OF_MEAN|0.24||0.684|TWO_SIDED|95.0|0.7|1.8||P-value was adjusted using Hochberg's adjustment for multiplicity.|Proportional Hazard Model|||||1.8|0.7|0.684
72621661|NCT00830336|144773567|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The pharmacokinetic parameters were evaluated statistically by an analysis of variance (ANOVA) appropriate for the experimental design of this study.|Geometric Test/Ref Ratio x 100|103.08||||||90.0|95.41|111.37|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||111.37|95.41|
72621662|NCT00830336|144773568|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The pharmacokinetic parameters were evaluated statistically by an analysis of variance (ANOVA) appropriate for the experimental design of this study.|Geometric Test/Ref Ratio x 100|105.84||||||90.0|99.33|112.77|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||112.77|99.33|
72621663|NCT00830336|144773569|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The pharmacokinetic parameters were evaluated statistically by an analysis of variance (ANOVA) appropriate for the experimental design of this study.|Geometric Test/Ref Ratio x 100|107.04||||||90.0|99.96|114.62|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||114.62|99.96|
72370692|NCT00488683|144251642|SUPERIORITY_OR_OTHER||R-square|0.28||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration at 12 months of age for the serogroup Y||||
72466193|NCT01475461|144455401|SUPERIORITY_OR_OTHER||LS Mean Difference|0.51|STANDARD_ERROR_OF_MEAN|0.511||0.315|TWO_SIDED|80.0|-0.14|1.17||P-value was 2-sided.|t-test, 2 sided|||Week 12: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||1.17|-0.14|0.3150
72466194|NCT01475461|144455401|SUPERIORITY_OR_OTHER||LS Mean Difference|0.23|STANDARD_ERROR_OF_MEAN|0.516||0.6631|TWO_SIDED|80.0|-0.44|0.89||P-value was 2-sided.|t-test, 2 sided|||Week 12: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.89|-0.44|0.6631
72466195|NCT01475461|144455401|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.512||0.8694|TWO_SIDED|80.0|-0.74|0.57||P-value was 2-sided.|t-test, 2 sided|||Week 12: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.57|-0.74|0.8694
72466196|NCT01475461|144455401|SUPERIORITY_OR_OTHER||LS Mean Difference|0.7|STANDARD_ERROR_OF_MEAN|0.545||0.2031|TWO_SIDED|80.0|0.0|1.4||P-value was 2-sided.|t-test, 2 sided|||Week 14: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||1.40|0.00|0.2031
72466197|NCT01475461|144455401|SUPERIORITY_OR_OTHER||LS Mean Difference|0.21|STANDARD_ERROR_OF_MEAN|0.563||0.7137|TWO_SIDED|80.0|-0.52|0.93||P-value was 2-sided.|t-test, 2 sided|||Week 14: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.93|-0.52|0.7137
72466198|NCT01475461|144455401|SUPERIORITY_OR_OTHER||LS Mean Difference|0.22|STANDARD_ERROR_OF_MEAN|0.545||0.681|TWO_SIDED|80.0|-0.48|0.92||P-value was 2-sided.|t-test, 2 sided|||Week 14: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.92|-0.48|0.6810
72466199|NCT01475461|144455401|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.55||0.6921|TWO_SIDED|80.0|-0.92|0.49||P-value was 2-sided.|t-test, 2 sided|||Week 14: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.49|-0.92|0.6921
72466200|NCT01475461|144455401|SUPERIORITY_OR_OTHER||LS Mean difference|-0.49|STANDARD_ERROR_OF_MEAN|0.545||0.3702|TWO_SIDED|80.0|-1.19|0.21||P-value was 2-sided.|t-test, 2 sided|||Week 14 (Follow-up): Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.21|-1.19|0.3702
72466201|NCT03214250|144455426|SUPERIORITY|One-sided|probability|0.577||||0.006|ONE_SIDED|95.0|0.417|||one-sided p-value|z-test|One-sided, one-sample z-test of the Kaplan-Meier estimate of the 1-year OS rate (and its standard error) against the historical rate of 35%||Each treatment arm was analyzed independently and compared to a historical 1-year OS reference rate of 35%.|||0.417|0.006
72466202|NCT03214250|144455426|SUPERIORITY|One-sided|probability|0.481||||0.062|ONE_SIDED|95.0|0.337|||one-sided p-value|z-test|One-sided, one-sample z-test of the Kaplan-Meier estimate of the 1-year OS rate (and its standard error) against the historical rate of 35%||Each treatment arm was analyzed independently and compared to a historical 1-year OS reference rate of 35%.|||0.337|0.062
72466203|NCT03214250|144455426|SUPERIORITY|One-sided|probability|0.413||||0.233|ONE_SIDED|95.0|0.27|||one-sided p-value|z-test|One-sided, one-sample z-test of the Kaplan-Meier estimate of the 1-year OS rate (and its standard error) against the historical rate of 35%||Each treatment arm was analyzed independently and compared to a historical 1-year OS reference rate of 35%.|||0.270|0.233
72466204|NCT00594178|144455438|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-250.8||||0.318|TWO_SIDED|95.0|-778.87|277.21|||t-test, 2 sided|||Paired samples T-test was used to assess the statisical changes between baseline and post-exercise lean muscle mass.||277.21|-778.87|.318
72370693|NCT00488683|144251642|SUPERIORITY_OR_OTHER||R-square|0.3||||||95.0|||||Regression, Linear|||Linear regression coefficient between demographic factors memory B cells one month after primary vaccination and serogroup specific IgG concentration at 12 months of age for the serogroup A||||
72466205|NCT00594178|144455439|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0645||||0.011|TWO_SIDED|95.0|0.01827|0.11073|||t-test, 2 sided|||Paired samples T-test was used to assess the statisical changes between baseline and post-exercise bone density.||.11073|.01827|.011
72466206|NCT00496626|144455440|SUPERIORITY_OR_OTHER||GMT ratio|101.6|||<=|0.05|TWO_SIDED|95.0|88.1|117.2||The ANCOVA models showed the lower bounds of two-sided 95% CI on the GMT ratio \[GARDASIL™/placebo\] were greater than 1 for each HPV type, so the null hypothesis was rejected. The CI reported is for HPV18, the type with the smallest CI lower bound.|ANCOVA||Superiority of GARDASIL™ to placebo was claimed if, for each of the four HPV types, the lower bound of the two-sided 95% CI on the GMT ratio \[GARDASIL™/placebo\] being \>1, or equivalently, the two-sided p-value \<0.05.|An Analysis of Covariance (ANCOVA) model was used for each HPV type, based on the pooled data from all age groups and genders. The natural-log-transformed titer was the response variable, and vaccination group, gender and age group were covariates. The null hypothesis was that the GMT ratio (Gardasil/Placebo) was equal to 1.||117.2|88.1|<=0.05
72466207|NCT00496626|144455441|SUPERIORITY_OR_OTHER||Seroconversion Rate|96.65|||<=|0.05||95.0|93.74|98.46||The lower bound of the 95% CI for the seroconversion rate was greater than 90% for each type so the null hypothesis was rejected. The CI reported is for HPV6, the type with the smallest lower bound.|Exact Binomial CI|||The null hypothesis was that the seroconversion rate in the Gardasil® Group was less than 90% for each HPV type.||98.46|93.74|<=0.05
72370694|NCT00488683|144251642|SUPERIORITY_OR_OTHER||R-square|0.1||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between demographic factors memory B cells one month after primary vaccination and serogroup specific IgG concentration at 12 months of age for the serogroup A||||
72370695|NCT00488683|144251642|SUPERIORITY_OR_OTHER||R-square|0.11||||||95.0|||||Regression, Linear|||Linear regression coefficient between demographic factors memory B cells one month after primary vaccination and serogroup specific IgG concentration at 12 months of age for the serogroup C||||
72394512|NCT02310568|144295786|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.0|STANDARD_ERROR_OF_MEAN|2.22||0.36|TWO_SIDED|90.0|-5.7|1.6|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1.||1.6|-5.7|0.360
72470170|NCT00609947|144464566|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|49.2|STANDARD_DEVIATION|21.8|<|0.001|ONE_SIDED|95.0||||"The null and alternative hypotheses were:~H0: µSVS ≥µM H1: µSVS \< µM where µSVS was the mean in-segment 8-month percent diameter stenosis for the SVS study and µM was the mean in-segment 6-month percent diameter stenosis for Micro-Driver."|t-test, 2 sided|The sample size was not reduced below 158 evaluable subjects in order to support the analysis of the primary safety endpoint.||The 8-month in-segment percent diameter stenosis from Endeavor SVS subjects was compared to the 6-month in-segment percent diameter stenosis from Micro Driver subjects. This study assessed the superiority of SVS against the Micro-Driver regarding in-segment percent diameter stenosis at 8 months post procedure.||||<0.001
72503228|NCT00095303|144537102|SUPERIORITY_OR_OTHER||Slope|0.12||||0.015|TWO_SIDED|95.0|0.03|0.22|||Mixed Models Analysis|||Null hypothesis: BSFT will be significantly more effective than TAU in improving family functioning.The four components of the 'Parenting Practices Inventory' will be used to create a composite for use in this analysis. The four component scales from the Parenting Practices Inventory are 'Positive Parenting', 'Discipline Effectiveness,' 'Avoidance of Discipline' and 'Monitoring' scales from the Pittsburgh Youth Survey. Hypothesis will be analyzed as using hierarchical linear models.||.22|.03|.015
72503229|NCT00095303|144537106|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.68||||0.12|TWO_SIDED|95.0|-0.18|1.54|||GEE|||||1.54|-.18|.12
72503230|NCT00095303|144537107|SUPERIORITY_OR_OTHER||Slope|0.33||||0.12|TWO_SIDED|95.0|-0.09|0.76|||GEE||The parameter estimated is the regression coefficient on the interaction of BSFT treatment assignment and the linear time trend.|Null hypothesis: BSFT will be significantly more effective than TAU in decreasing sexually risky behaviors. The total score of the 'HIV/Sex Risk Behaviors' measure will be used as the outcome.Hypothesis analyzed using the hierarchical linear model.||.76|-.09|.12
72503231|NCT00095303|144537111|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.14||||0.23|TWO_SIDED|95.0|-0.09|0.37|||GEE|||||.37|-.09|.23
72503232|NCT01364467|144537112|OTHER|||||||0.013|||||||t-test, 2 sided|||||||0.013
72503233|NCT01364467|144537113|SUPERIORITY|||||||0.98|||||||t-test, 2 sided|||||||0.98
72503234|NCT01364467|144537113|SUPERIORITY|||||||0.65|||||||t-test, 2 sided|||||||0.65
72503235|NCT01499576|144537115|SUPERIORITY_OR_OTHER||percent agreement|89.2|||||TWO_SIDED|||||||||||||
72503236|NCT01499576|144537116|SUPERIORITY_OR_OTHER||Kappa index of agreement|0.808|||<|0.01|TWO_SIDED||||||Kappa index of agreement|||||||<0.01
72503237|NCT01499576|144537117|SUPERIORITY_OR_OTHER||persent of adverse event|10.48|||||TWO_SIDED|||||||||||||
72503238|NCT03842137|144537129|SUPERIORITY||Slope|-0.53|STANDARD_ERROR_OF_MEAN|0.19||0.008|TWO_SIDED|95.0|-0.91|-0.15|||Regression, Linear|Utilizing a regression model, baseline craving scores, group condition, and their interaction are regressed on 2-week craving scores.||||-.15|-.91|.008
72370696|NCT00488683|144251642|SUPERIORITY_OR_OTHER||R-square|0.06||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between demographic factors memory B cells one month after primary vaccination and serogroup specific IgG concentration at 12 months of age for the serogroup C||||
72503239|NCT03842137|144537130|SUPERIORITY|An ancova model was conducted comparing differences between tDCS and sham on post-stimulation theta burst rate, while controlling for pre-stimulation theta burst rate||||||0.005|||||||ANCOVA|||||||.005
72503240|NCT03959189|144537138|SUPERIORITY||mixed effects model|-0.0796|STANDARD_ERROR_OF_MEAN|0.2768||0.7746|TWO_SIDED|95.0|-0.6|0.5|||Mixed Models Analysis|||A mixed effects model will be used to compare SSS effects following ERX-963 versus placebo. In the primary analysis of SSS, the cohort 1 and cohort 2 data were combined for ERX-963 and placebo treatments.||0.5|-0.6|0.7746
72503241|NCT03959189|144537138|SUPERIORITY||mixed effects model|-0.2608|STANDARD_ERROR_OF_MEAN|0.3589||0.47|TWO_SIDED|95.0|-1.0|0.5|||Mixed Models Analysis|||A mixed effects model will be used to compare SSS effects following 1 mg ERX-963 versus placebo. In this analysis of SSS, the effect of 1 mg ERX-963 treatment was compared to the effect of placebo treatment.||0.5|-1.0|0.4700
72503242|NCT03959189|144537138|SUPERIORITY||mixed effects model|0.1016|STANDARD_ERROR_OF_MEAN|0.4272||0.8127|TWO_SIDED|95.0|-0.8|1.0|||Mixed Models Analysis|||A mixed effects model will be used to compare SSS effects following 2 mg ERX-963 versus placebo. In this analysis of SSS, the effect of 2 mg ERX-963 treatment was compared to the effect of placebo treatment.||1.0|-0.8|0.8127
72503243|NCT03322657|144537166|SUPERIORITY||Hazard Ratio (HR)|3.8|||<|0.001|TWO_SIDED|95.0|2.2|6.5|||Cox proportional hazard model|||||6.5|2.2|<0.001
72503244|NCT03322657|144537167|SUPERIORITY||Median Difference (Final Values)|6.3||||0.13|TWO_SIDED|95.0|-2.0|14.0|||Wilcoxon (Mann-Whitney)|||||14|-2.0|0.13
72503245|NCT03322657|144537168|SUPERIORITY||Hazard Ratio (HR)|0.75||||0.3|TWO_SIDED|95.0|0.43|1.34|||Cox proportional hazard model|||||1.34|0.43|0.30
72503246|NCT03322657|144537169|SUPERIORITY||Mean Difference (Final Values)|0.33||||0.21|TWO_SIDED|95.0|-0.35|1.0|||t-test, 2 sided|||||1.00|-0.35|0.21
72503247|NCT03322657|144537170|SUPERIORITY||Mean Difference (Final Values)|0.82||||0.04|TWO_SIDED|95.0|-0.18|1.81|||t-test, 2 sided|||||1.81|-0.18|0.04
72503248|NCT00843180|144537192|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6|STANDARD_DEVIATION|0.0||0.8|TWO_SIDED|95.0|-5.4|4.2||unadjusted|t-test, 2 sided||this was a feasibility pilot study CI is descriptor of dispersion|comparison between groups by t-test||4.2|-5.4|0.80
72503249|NCT00843180|144537193|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.38|STANDARD_DEVIATION|0.0||0.29|TWO_SIDED|95.0|-6.9|2.1||unadjusted|t-test, 2 sided||CI serves as dispersion measure|||2.1|-6.9|0.29
72503250|NCT00843180|144537194|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-3.8|STANDARD_DEVIATION|0.0||0.78|TWO_SIDED|95.0|-31.9|24.3|||t-test, 2 sided||95% CI is dispersion parameter|||24.3|-31.9|0.78
72503251|NCT00843180|144537195|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.8|STANDARD_DEVIATION|0.0||0.7|TWO_SIDED|95.0|-9.5|13.2|||t-test, 2 sided|unadjusted|95%CI is dispersion measure|||13.2|-9.5|0.70
72503252|NCT01477450|144537207|SUPERIORITY_OR_OTHER|||||||0.3|||||||Chi-squared|||||||0.3
72503253|NCT01477450|144537207|SUPERIORITY_OR_OTHER|||||||0.47|||||||Chi-squared|||||||0.47
72503254|NCT01477450|144537207|SUPERIORITY_OR_OTHER|||||||1|||||||Chi-squared|||||||1.00
72503255|NCT02234622|144537220|SUPERIORITY||Mean Difference (Final Values)|-5.0|STANDARD_ERROR_OF_MEAN|1.6||0.002|TWO_SIDED|95.0|-8.2|-1.8|||Mixed Models Analysis|||||-1.8|-8.2|0.002
72503256|NCT02234622|144537221|SUPERIORITY||Mean Difference (Net)|-6.1|STANDARD_ERROR_OF_MEAN|2.2||0.005|TWO_SIDED|95.0|-10.3|-1.8|||Mixed Models Analysis|||||-1.8|-10.3|0.005
72503257|NCT02234622|144537222|SUPERIORITY||Mean Difference (Final Values)|-6.7|STANDARD_ERROR_OF_MEAN|2.6||0.042|TWO_SIDED|95.0|-11.9|-1.6|||Mixed Models Analysis|||||-1.6|-11.9|0.042
72503258|NCT02234622|144537223|SUPERIORITY||Mean Difference (Final Values)|-1.5|STANDARD_ERROR_OF_MEAN|1.4||0.482|TWO_SIDED|95.0|-4.2|1.1|||Mixed Models Analysis|||||1.1|-4.2|0.482
72503259|NCT02234622|144537224|SUPERIORITY||Mean Difference (Final Values)|-1.4|STANDARD_ERROR_OF_MEAN|1.7||0.635|TWO_SIDED|95.0|-4.7|1.9|||Mixed Models Analysis|||||1.9|-4.7|0.635
72503260|NCT02234622|144537225|SUPERIORITY||Mean Difference (Final Values)|-2.4|STANDARD_ERROR_OF_MEAN|1.8||0.367|TWO_SIDED|95.0|-6.0|1.1|||Mixed Models Analysis|||||1.1|-6.0|0.367
72466208|NCT02005393|144455449|NON_INFERIORITY_OR_EQUIVALENCE|Image settings were considered non-inferior if scores overlapped within 1 SD of mean.||||||||||||||||All 20 subjects enrolled in the study, including Subject 219 that was dropped from the Reader assessments due to corrupted images, were all rated as having similar white light images between the FICE and NBI procedures for each location used in the concurrence study. This assessment was intended to assure that no procedural sequence or visualization bias was introduced into the image acquisition process. The overall Reader mean (SD) for both FICE and NBI were equal to or greater than 3.0 (0.8).|The results reported utilized the average Likert scores for each of the 3 readers, for each of the FICE settings (0-9), as compared to FICE. The overall Reader mean (SD) for both FICE and NBI were equal to or greater than 3.0 (0.8).The overall mean scores were comparable between FICE and NBI to provide acceptable diagnostic image visualization quality.|||
72470171|NCT00609947|144464567|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|13.5|STANDARD_ERROR_OF_MEAN|6.5||0.0041|ONE_SIDED|95.0||20.0|||t-test, 1 sided|||"The null and alternative hypotheses of interest are:~H0: xSVS \>= 20% vs. H1: xSVS \< 20%, where x is the true SVS 12-month MACE rate.~The assessment of the null hypothesis will be carried out at the one-sided 0.05 level of significance. Rejection of the null hypothesis indicates the SVS 12-month MACE rate is significantly below 20%."||20||0.0041
72470172|NCT01304498|144464573|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority required that the lower bound of the two-sided confidence interval (CI) of the GMT ratio was \>0.67|GMT Ratio|0.97|||<|0.001|TWO_SIDED|95.0|0.85|1.11|||ANOVA||GMT ratio = GMT (V503) / GMT (Gardasil)|HPV Type 16||1.11|0.85|<0.001
72503261|NCT02234622|144537226|SUPERIORITY||Mean Difference (Final Values)|0.3|STANDARD_ERROR_OF_MEAN|0.4||0.668|TWO_SIDED|95.0|-0.5|1.0|||Mixed Models Analysis|||||1.0|-0.5|0.668
72470173|NCT01304498|144464573|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority required that the lower bound of the two-sided confidence interval (CI) of the GMT ratio was \>0.67|GMT Ratio|1.08|||<|0.001|TWO_SIDED|95.0|0.91|1.29|||ANOVA||GMT ratio = GMT (V503) / GMT (Gardasil)|HPV Type 18||1.29|0.91|<0.001
72466209|NCT02971228|144455456|OTHER|A paired t-test was used for the parametric method to compare patients receiving both treatments. A patient was required to have data for both periods to be included in the pre-specified analysis for a given endpoint. Thus, the 2 patients who withdrew from the trial after the Lilly Glucagon treatment before receiving ZP4207 were not included in the analysis.|Mean Difference (Final Values)|-6.9||||0.2518|TWO_SIDED|95.0|-19.63|5.84|||t-test, 2 sided||The estimated mean difference is based on the difference between the mean values for 10 patients in the ZP4207 group (12.78) and the matching 10 patients in the Lilly glucagon group (19.67)|A paired t-test or the Wilcoxon signed rank test for comparison of means with normally or non normally distributed residuals, respectively, was used. The Shapiro-Wilk test was used to determine the normality of the residuals for each comparison. The residuals were obtained from an analysis of variance (ANOVA) model with treatment group as the fixed effect. If the p-value of the test was \<0.001, the non-parametric method was utilized to analyze the endpoint parameter.||5.84|-19.63|0.2518
72564465|NCT03877926|144660527|OTHER||Percentage of participants|66.3|||||TWO_SIDED|95.0|64.5|68.1||||||||68.1|64.5|
72394513|NCT02310568|144295788|SUPERIORITY_OR_OTHER||LS Mean Difference|0.9|STANDARD_ERROR_OF_MEAN|2.36||0.708|TWO_SIDED|90.0|-3.2|5.0|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - Placebo). Week 5: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 2 was Week 4 (Day 28).||5.0|-3.2|0.708
72621664|NCT04526158|144773621|SUPERIORITY||Mean Difference (Final Values)|0.3||||0.031|TWO_SIDED|95.0|0.0|0.6||significance threshold = 0.0167 due to multiple comparisons|Mixed Models Analysis|Linear mixed model adjusted for baseline values of BPI interference, Pain Self-Efficacy, and design factors|estimates were generated from multiple imputed data|||0.6|0.0|0.031
72621665|NCT04526158|144773621|SUPERIORITY||Mean Difference (Final Values)|-0.4||||0.002|TWO_SIDED|95.0|-0.7|-0.2||significance threshold = 0.0167 due to multiple comparisons|Mixed Models Analysis|Linear mixed model adjusted for baseline values of BPI interference, Pain Self-Efficacy, and design factors|estimates were generated from multiple imputed data|||-0.2|-0.7|0.002
72564466|NCT03877926|144660528|NON_INFERIORITY|A non-inferiority margin of -15% was used for the difference in percentage of AV7909 participants (pooled from three AV7909 study groups \[Lot 1, 2, and 3\]) vs. BioThrax participants who achieved TNA NF50 ≥0.29 at Day 64. The success criterion was defined as the lower bound of 95% confidence interval of the difference in the percentage of AV7909 vs. BioThrax participants being greater than -15%.|Difference in percentage|24.5|||||TWO_SIDED|95.0|20.0|29.2||||||||29.2|20.0|
72621666|NCT04526158|144773621|SUPERIORITY||Mean Difference (Final Values)|-0.7|||<|0.001|TWO_SIDED|95.0|-1.0|-0.4||significance threshold = 0.0167 due to multiple comparisons|Mixed Models Analysis|Linear mixed model adjusted for baseline values of BPI interference, Pain Self-Efficacy, and design factors|estimates were generated from multiple imputed data|||-0.4|-1.0|<0.001
72394514|NCT02310568|144295788|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|2.36||0.646|TWO_SIDED|90.0|-5.2|3.0|||Mixed-Effects Model Repeated Measure|||(PF-06372865 2.5 mg - Placebo). Week 5: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 2 was Week 4 (Day 28).||3.0|-5.2|0.646
72564467|NCT03877926|144660529|OTHER|Relative risk of serious adverse events incidence between AV7909 (combined from all three AV7909 lots) and BioThrax.|Relative risk (AV7909/BioThrax)|2.5|||||TWO_SIDED|95.0|0.9|6.5|||||The 95% CI of the relative risk was derived using the Farrington-Manning relative risk score statistic.|||6.5|0.9|
72564468|NCT03877926|144660530|OTHER|Success criteria was defined as the lower bound for the 95% CI for the proportion of participants pooled from all three AV7909 study groups with TNA NF50 ≥0.15 to be ≥67%.|Percentage of participants|97.8|||||TWO_SIDED|95.0|97.2|98.3||||||||98.3|97.2|
72564469|NCT03877926|144660532|OTHER|Relative risk of adverse events of special interest (events of autoimmune etiology) incidence between AV7909 (combined from all three AV7909 lots) and BioThrax.|Relative risk (AV7909/BioThrax)|1.3|||||TWO_SIDED|95.0|0.3|5.0|||||The 95% CI of the relative risk was derived using the Farrington-Manning relative risk score statistic.|||5.0|0.3|
72564470|NCT02240186|144660538|SUPERIORITY|||||||0.01|||||||ANOVA|||||||0.01
72564471|NCT02240186|144660539|SUPERIORITY|||||||0.01|||||||ANOVA|||||||0.01
72564472|NCT02240186|144660540|SUPERIORITY|||||||0.01|||||||ANOVA|||||||0.01
72564473|NCT01352182|144660555|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||||||1.0
72564474|NCT01352182|144660556|SUPERIORITY|||||||1||||||threshold for significance p\<0.05|Wilcoxon (Mann-Whitney)|||||||1.0
72564475|NCT01352182|144660557|SUPERIORITY|||||||0.154||||||threshold for significance p\<0.05|Wilcoxon (Mann-Whitney)|||||||0.154
72564476|NCT01352182|144660558|SUPERIORITY|||||||0.683||||||significance threshold p\<0.05|Wilcoxon (Mann-Whitney)|||||||0.683
72564477|NCT01352182|144660559|SUPERIORITY|||||||0.08||||||significance threshold p\<0.05|t-test, 2 sided|||||||0.08
72564478|NCT01352182|144660560|OTHER|linear regression|Slope|-1.44|STANDARD_ERROR_OF_MEAN|0.3741||0.003|TWO_SIDED||||||Regression, Linear|||||||0.003
72564479|NCT03297294|144660564|SUPERIORITY|at week 12|least squares mean|-0.6|STANDARD_ERROR_OF_MEAN|0.39||0.101|TWO_SIDED|95.0|-1.4|0.1|||ANCOVA|||||0.1|-1.4|0.101
72564480|NCT03297294|144660565|SUPERIORITY||LS mean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.38||0.168|TWO_SIDED|95.0|-1.3|0.2|||ANCOVA|||At week 12||0.2|-1.3|0.168
72564481|NCT03297294|144660569|SUPERIORITY||Odds Ratio (OR)|1.6||||0.255|TWO_SIDED|95.0|0.7|3.9|||Regression, Logistic|||Week 12||3.9|0.7|0.255
72564482|NCT03297294|144660570|SUPERIORITY||Odds Ratio (OR)|2.8||||0.1|TWO_SIDED|95.0|0.8|9.6|||Regression, Logistic|||||9.6|0.8|0.100
72564483|NCT02776553|144660596|SUPERIORITY|||||||0.49|||||||ANCOVA|||||||0.49
72564484|NCT02776553|144660597|SUPERIORITY|||||||0.03|||||||ANCOVA|||||||0.03
72564485|NCT02776553|144660598|SUPERIORITY|||||||0.37|||||||ANCOVA|||||||0.37
72564486|NCT01056640|144660606|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.31|STANDARD_ERROR_OF_MEAN|0.2865||0.05|TWO_SIDED|95.0|0.747|2.297|||Wilcoxon (Mann-Whitney)|Wilcoxon Rank Sum test, 2-sample t-test and Chi-square analysis were all used.||All analyses were performed using an intent-to-treat method. Wilcoxon rank sum test, 2-sample t test, or Chi-Square analysis was used to compare baseline characteristics. The primary end points of combined and individual percentages of hospitalizations and ED visits were compared using Chi-Square test. Statistical adjustment was planned only if there were statistical differences in clinical variables between the groups. All tests for significance used a 2-sided P value of .05.||2.297|0.747|0.05
72503262|NCT03478683|144537267|NON_INFERIORITY|Non-inferiority was to be demonstrated, if the lower bound of the two-sided 95 percentage (%) confidence interval around the (FF/UMEC/VI versus BUD/FOR+TIO) treatment difference was above -50 milliliter.|Mean Difference (Net)|0.015|STANDARD_ERROR_OF_MEAN|0.0143|||TWO_SIDED|95.0|-0.013|0.043|||||The primary treatment effect estimated (hypothetical effect) excluded data following intercurrent events: discontinuation of treatment, taking wrong treatment, taking prohibited medication, unblinding, noncompliance, COPD exacerbation or pneumonia.|||0.043|-0.013|
72503263|NCT03478683|144537268|SUPERIORITY||Mean Difference (Net)|-0.01|STANDARD_ERROR_OF_MEAN|0.0139||0.481|TWO_SIDED|95.0|-0.037|0.018||Only if superiority is achieved on the primary study endpoint, then inferences can be made on change from Baseline in trough FEV1 on Day 2 using p-values.|Mixed model repeated measures||Day 2|||0.018|-0.037|0.481
72503264|NCT03478683|144537268|SUPERIORITY||Mean Difference (Net)|0.061|STANDARD_ERROR_OF_MEAN|0.0124|<|0.001|TWO_SIDED|95.0|0.037|0.086||Only if superiority is achieved on the primary study endpoint, then inferences can be made on change from Baseline in trough FEV1 on Day 28 using p-values.|Mixed model repeated measures||Day 28|||0.086|0.037|<0.001
72503265|NCT03478683|144537268|SUPERIORITY||Mean Difference (Net)|0.058|STANDARD_ERROR_OF_MEAN|0.0133|<|0.001|TWO_SIDED|95.0|0.032|0.084||Only if superiority is achieved on the primary study endpoint, then inferences can be made on change from Baseline in trough FEV1 on Day 84 using p-values.|Mixed model repeated measures||Day 84|||0.084|0.032|<0.001
72503266|NCT03478683|144537268|SUPERIORITY||Mean Difference (Net)|0.038|STANDARD_ERROR_OF_MEAN|0.014||0.007|TWO_SIDED|95.0|0.01|0.066||Only if superiority is achieved on the primary study endpoint, then inferences can be made on change from Baseline in trough FEV1 on Day 85 using p-values.|Mixed model repeated measures||Day 85|||0.066|0.010|0.007
72503267|NCT03478683|144537269|SUPERIORITY||Mean Difference (Net)|-0.009|STANDARD_ERROR_OF_MEAN|0.011||0.415|TWO_SIDED|95.0|-0.03|0.013||Only if superiority is achieved on the primary study endpoint, then inferences can be made on weighted mean change from Baseline in FEV1 over 0-24 hours on Day 1 using p-values.|Mixed model repeated measures||The treatment effect to be estimated was hypothetical effect if all participants stayed on their randomized study treatment. Only on treatment data was included in analysis.|||0.013|-0.030|0.415
72503268|NCT03478683|144537270|SUPERIORITY||Mean Difference (Net)|0.013|STANDARD_ERROR_OF_MEAN|0.0138||0.335|TWO_SIDED|95.0|-0.014|0.04||The analysis was performed using mixed model repeated measures analysis, which included covariates of Baseline FEV1, geographical region, treatment, visit, visit by treatment and visit by Baseline interaction.|Mixed model repeated measures||The treatment effect to be estimated was hypothetical effect if all participants stayed on their randomized study treatment. Only on treatment data was included in analysis.|||0.040|-0.014|0.335
72503269|NCT05175170|144537271|OTHER||Mean Difference (Final Values)|-33.902|||<|0.001|TWO_SIDED||||||t-test, 1 sided|||The hypothesis of this analysis was that using the AFFRMED would increase fertility-related knowledge. This paired-samples t-test compares participants' pre- and post-test knowledge scores.||||<.001
72503270|NCT05175170|144537271|OTHER||Mean Difference (Final Values)|-26.098|||<|0.001|TWO_SIDED||||||t-test, 1 sided|||The hypothesis of this analysis was that using the AFFRMED would increase fertility-related knowledge. This paired-samples t-test compares participants' pre- and post-test knowledge scores.||||<.001
72503271|NCT05175170|144537272|OTHER||Mean Difference (Final Values)|-20.202||||0.002|TWO_SIDED||||||t-test, 1 sided|||The hypothesis of this analysis was that using the AFFRMED would increase fertility-related decision self-efficacy. This paired-samples t-test compares participants' pre- and post-test decision self-efficacy scores.||||0.002
72503272|NCT05175170|144537272|OTHER||Mean Difference (Final Values)|-8.081||||0.051|TWO_SIDED||||||t-test, 1 sided|||The hypothesis of this analysis was that using the AFFRMED would increase fertility-related decision self-efficacy. This paired-samples t-test compares participants' pre- and post-test decision self-efficacy scores.||||0.051
72503273|NCT04090164|144537276|OTHER||Odds Ratio (OR)|2.406||||0.0027|TWO_SIDED|95.0|1.341|4.316|||Fisher Exact|||Fisher exact test was used for testing of association of Breast Cancer diagnosis with anti-HCV test status.||4.316|1.341|0.0027
72503274|NCT04090164|144537276|OTHER||Odds Ratio (OR)|7.032||||0.0034|TWO_SIDED|95.0|1.582|31.25|||Fisher Exact|||Fisher exact test was used to test the association of Breast Cancer diagnosis with anti-HCV test result in women younger than 45 years.||31.25|1.582|0.0034
72503275|NCT01650805|144537278|SUPERIORITY_OR_OTHER|||||||0.074|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified Analysis by Sokal score||||||0.074
72503276|NCT01650805|144537280|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified Analysis by Sokal score||||||<0.001
72503277|NCT01650805|144537281|SUPERIORITY_OR_OTHER|||||||0.317|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified Analysis by Sokal score||||||0.317
72503278|NCT00770861|144537289|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|Between-treatment comparison of efficacy was performed by ANCOVA, with treatment, baseline BMI, center as factors \& baseline value as a covariate.||H0 - There was no difference in BP reduction between Neb and Placebo. The efficacy analyses were based on the ITT population for the double-blind treatment phase. The LOCF was used to impute missing postbaseline values. Sensitivity analyses were based on observed cases for all efficacy parameters. All statistical tests were two-sided hypothesis tests performed at the 5% level of significance for main effects. All confidence intervals were two-sided 95% confidence intervals.||||<0.0001
72503279|NCT00770861|144537290|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||ANCOVA|||||||0.001
72564487|NCT00925301|144660629|SUPERIORITY||Difference|12.5||||0.2996|TWO_SIDED|95.0|-13.4|37.3|||Cochran-Mantel-Haenszel|p-value from Cochran-Mantel-Haenszel test stratified by sex|The difference between the percentage of successes between migalastat and placebo treatment groups|||37.3|-13.4|0.2996
72370697|NCT00488683|144251642|SUPERIORITY_OR_OTHER||R-square|0.17||||||95.0|||||Regression, Linear|||Linear regression coefficient between demographic factors memory B cells one month after primary vaccination and serogroup specific IgG concentration at 12 months of age for the serogroup W-135||||
72503280|NCT00630032|144537297|SUPERIORITY||Hazard Ratio (HR)|0.8||||0.175|TWO_SIDED|95.0|0.59|1.1|||Log Rank|||||1.10|0.59|0.175
72503281|NCT00630032|144537298|SUPERIORITY||Hazard Ratio (HR)|0.77||||0.1687|TWO_SIDED|95.0|0.53|1.11|||Log Rank|||||1.11|0.53|0.1687
72503282|NCT00630032|144537299|SUPERIORITY||Hazard Ratio (HR)|0.86||||0.6502|TWO_SIDED|95.0|0.45|1.63|||Log Rank|||||1.63|0.45|0.6502
72503283|NCT00630032|144537300|SUPERIORITY||Hazard Ratio (HR)|0.71||||0.0665|TWO_SIDED|95.0|0.49|1.02|||Log Rank|||||1.02|0.49|0.0665
72503284|NCT00630032|144537301|SUPERIORITY||Hazard Ratio (HR)|0.8||||0.148|TWO_SIDED|95.0|0.59|1.08|||Log Rank|||||1.08|0.59|0.148
72503285|NCT00630032|144537302|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.8968|TWO_SIDED|95.0|0.67|1.42|||Log Rank|||||1.42|0.67|0.8968
72503286|NCT03191786|144537330|SUPERIORITY||Hazard Ratio (HR)|0.78||||0.025|TWO_SIDED|95.0|0.63|0.97|||Log Rank|||Stratified analysis. Histologic subtype, PD-L1 IHC status and brain metastases (Yes/No) were added as stratification factors.||0.97|0.63|0.025
72503287|NCT03191786|144537331|SUPERIORITY||Difference in OS Rates|6.5|||||TWO_SIDED|95.0|-3.3|16.3||||||OS Rate at 6 Months||16.3|-3.3|
72503288|NCT03191786|144537331|SUPERIORITY||Difference in OS Rates|5.1|||||TWO_SIDED|95.0|-4.9|15.0||||||OS Rate at 12 Months||15.0|-4.9|
72503289|NCT03191786|144537331|SUPERIORITY||Difference in OS Rates|7.4|||||TWO_SIDED|95.0|-1.6|16.5||||||OS Rate at 18 Months||16.5|-1.6|
72503290|NCT03191786|144537331|SUPERIORITY||Difference in OS Rates|11.9|||||TWO_SIDED|95.0|4.4|19.5||||||OS Rate at 24 Months||19.5|4.4|
72503291|NCT03191786|144537333|SUPERIORITY||Hazard Ratio (HR)|0.87||||0.182|TWO_SIDED|95.0|0.7|1.07|||Log Rank|||Stratified analysis. Histologic subtype, PD-L1 IHC status and brain metastases (Yes/No) were added as stratification factors.||1.07|0.70|0.182
72503292|NCT03191786|144537338|SUPERIORITY|Stratified analysis. Histologic subtype, PD-L1 IHC status and brain metastases (Yes/No) were added as stratification factors.|Hazard Ratio (HR)|1.01||||0.975||95.0|0.57|1.78|||Log Rank|||Time to deterioration for Dyspnoea (single item QLQ-C30)||1.78|0.57|0.975
72503293|NCT03191786|144537338|SUPERIORITY|Stratified analysis. Histologic subtype, PD-L1 IHC status and brain metastases (Yes/No) were added as stratification factors.|Hazard Ratio (HR)|0.89||||0.62|TWO_SIDED|95.0|0.55|1.42|||Log Rank|||Time to deterioration for Fatigue (multi items QLQ-C30)||1.42|0.55|0.620
72503294|NCT03191786|144537339|SUPERIORITY|Stratified analysis. Histologic subtype, PD-L1 IHC status and brain metastases (Yes/No) were added as stratification factors.|Hazard Ratio (HR)|1.16||||0.653|TWO_SIDED|95.0|0.6|2.26|||Log Rank|||Time to deterioration for Cough (single item QLQ-LC13)||2.26|0.60|0.653
72503295|NCT03191786|144537339|SUPERIORITY|Stratified analysis. Histologic subtype, PD-L1 IHC status and brain metastases (Yes/No) were added as stratification factors.|Hazard Ratio (HR)|0.51||||0.036|TWO_SIDED|95.0|0.27|0.97|||Log Rank|||Time to deterioration for Chest pain (single item QLQ-LC13)||0.97|0.27|0.036
72503296|NCT03191786|144537339|SUPERIORITY|Stratified analysis. Histologic subtype, PD-L1 IHC status and brain metastases (Yes/No) were added as stratification factors.|Hazard Ratio (HR)|0.7||||0.125|TWO_SIDED|95.0|0.45|1.11|||Log Rank|||Time to deterioration for Dyspnoea (multiple items QLQ-LC13)||1.11|0.45|0.125
72564488|NCT00925301|144660632|OTHER|Mixed effects model for repeated measures (MMRM) approach with fixed effects of treatment, time (Month 6 and Month 12), mutation type (amenable or non-amenable), time by treatment interaction, time by mutation type interaction, and the baseline value as a covariate. An unstructured covariance matrix to account for repeated measures within a participant was assumed.||||||0.014||||||Significant at the 0.050 level|MMRM|||||||0.014
72564489|NCT00925301|144660633|OTHER||Difference LSMeans|-0.3||||0.0078|TWO_SIDED|95.0|-0.6|-0.1||Significant at the 0.010 level|ANCOVA|||The change from Baseline in the average number of kidney ICs was analyzed using an ANCOVA model with covariate adjustment for the baseline value and factors for treatment group and the treatment by baseline interaction.||-0.1|-0.6|0.0078
72503297|NCT03191786|144537339|SUPERIORITY|Stratified analysis. Histologic subtype, PD-L1 IHC status and brain metastases (Yes/No) were added as stratification factors.|Hazard Ratio (HR)|0.75||||0.362|TWO_SIDED|95.0|0.41|1.39|||Log Rank|||Time to deterioration for Arm and/or shoulder pain (single item QLQ-LC13)||1.39|0.41|0.362
72503298|NCT03191786|144537339|SUPERIORITY|Stratified analysis. Histologic subtype, PD-L1 IHC status and brain metastases (Yes/No) were added as stratification factors.|Hazard Ratio (HR)|0.68||||0.041|TWO_SIDED|95.0|0.46|0.99|||Log Rank|||Time to Confirmed Deterioration for the Composite of the 3 following symptoms: cough, dyspnoea (multi-items QLQ-LC13) and chest pain||0.99|0.46|0.041
72503299|NCT03191786|144537340|SUPERIORITY|Stratified analysis. Histologic subtype, PD-L1 IHC status and brain metastases (Yes/No) were added as stratification factors.|Hazard Ratio (HR)|0.84||||0.272|TWO_SIDED|95.0|0.61|1.15|||Log Rank|||SP263 TC\>=1%||1.15|0.61|0.272
72503300|NCT03191786|144537341|SUPERIORITY|Stratified analysis. Histologic subtype, PD-L1 IHC status and brain metastases (Yes/No) were added as stratification factors.|Hazard Ratio (HR)|0.87||||0.366|TWO_SIDED|95.0|0.64|1.18|||Log Rank|||SP263 TC\>=1%||1.18|0.64|0.366
72503301|NCT03518840|144537350|SUPERIORITY||Mean Difference (Final Values)|-1.9615|STANDARD_ERROR_OF_MEAN|0.3329|<|0.001|TWO_SIDED|95.0|-2.6299|-1.2932|||paired t-test, 2 sided|||The null hypothesis is that there is no change in the baseline ASLR score following four weeks of SIJ belt therapy.||-1.2932|-2.6299|<.001
72503302|NCT03518840|144537351|SUPERIORITY||Median Difference (Final Values)|-1.9474|STANDARD_ERROR_OF_MEAN|0.3353|<|0.001|TWO_SIDED|95.0|-2.619|-1.2757|||paired t-test, 2 sided|||The null hypothesis is that there is no change in the baseline NRS score following four weeks of SIJ belt therapy.||-1.2757|-2.6190|<.001
72503303|NCT05652660|144537352|OTHER|Mixed Model|Ratio (%) of Adjusted Geometric Means|120.5|||||TWO_SIDED|90.0|104.77|138.59|||||The ratios (and 90% CIs) are expressed as percentages.|Rosuvastatin administered alone as the Reference and ARV-471 coadministered with rosuvastatin as the Test. Natural log transformed Cmax was analyzed using a mixed effect model with treatment as fixed effects and participant as a random effect. Estimates of the adjusted mean differences (Test-Reference) and corresponding 90% CIs were obtained from the model and were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||138.59|104.77|
72503304|NCT05652660|144537353|OTHER|Mixed Model|Ratio (%) of Adjusted Geometric Means|110.56|||||TWO_SIDED|90.0|103.53|118.06|||||The ratios (and 90% CIs) are expressed as percentages.|Rosuvastatin administered alone as the Reference and ARV-471 coadministered with rosuvastatin as the Test. Natural log transformed AUClast was analyzed using a mixed effect model with treatment as fixed effects and participant as a random effect. Estimates of the adjusted mean differences (Test-Reference) and corresponding 90% CIs were obtained from the model and were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||118.06|103.53|
72503305|NCT03440112|144537407|SUPERIORITY||Chi-Squared|3.0039||||0.391|TWO_SIDED||||||Mixed Models Analysis|||A pair of random-intercept mixed linear models was fitted, a visit model and an interaction model. Visit model included fixed effect of visit and a random intercept by participant. Interaction model adds an interaction by treatment term on top of the visit model. Null hypothesis is that visit by treatment interaction does not explain significant additional variance in clinical outcome scores. Likelihood ratio test comparing the interaction model to the visit model was used to derive a p-value.||||0.391
72503306|NCT03440112|144537408|SUPERIORITY||Chi-Squared|9.4836||||0.02351|TWO_SIDED||||||Mixed Models Analysis|||A pair of random-intercept mixed linear models was fitted, a visit model and an interaction model. Visit model included fixed effect of visit and a random intercept by participant. Interaction model adds an interaction by treatment term on top of the visit model. Null hypothesis is that visit by treatment interaction does not explain significant additional variance in clinical outcome scores. Likelihood ratio test comparing the interaction model to the visit model was used to derive a p-value.||||0.02351
72503307|NCT03199911|144537409|SUPERIORITY||Risk Ratio (RR)|0.0||||0.025|TWO_SIDED||||||Fisher Exact|||||||0.025
72503308|NCT03199911|144537411|SUPERIORITY||Risk Ratio (RR)|1.3||||0.77|TWO_SIDED|95.0|0.42|4.03|||Fisher Exact|||||4.03|0.42|0.77
72503309|NCT03199911|144537412|SUPERIORITY||Risk Ratio (RR)|0.93||||1|TWO_SIDED|95.0|0.06|14.77|||Fisher Exact|||||14.77|0.06|1.00
72503310|NCT01009463|144537413|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.87||||0.181|TWO_SIDED|95.0|0.72|1.06|||Generalized Linear Model|Assuming Negative Binomial distribution with logarithm of time on treatment as an offset variable.||||1.06|0.72|0.181
72503311|NCT01009463|144537413|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.66|||<|0.001|TWO_SIDED|95.0|0.54|0.81||Nominal p-value|Generalized Linear Model|Assuming Negative Binomial distribution with logarithm of time on treatment as an offset variable.||||0.81|0.54|<0.001
72564490|NCT01117766|144660643|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.19|STANDARD_ERROR_OF_MEAN|0.537||0.7319|TWO_SIDED|95.0|-1.29|0.92|||ANCOVA|||Week 3 (Visits 3 and 6)||0.92|-1.29|0.7319
72394515|NCT02310568|144295788|SUPERIORITY_OR_OTHER||LS Mean Difference|2.0|STANDARD_ERROR_OF_MEAN|2.09||0.352|TWO_SIDED|90.0|-1.6|5.6|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 5: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 2 was Week 4 (Day 28).||5.6|-1.6|0.352
72394516|NCT02310568|144295788|SUPERIORITY_OR_OTHER||LS Mean Difference|2.1|STANDARD_ERROR_OF_MEAN|2.99||0.495|TWO_SIDED|90.0|-3.1|7.3|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - Placebo). Week 6: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 2 was Week 4 (Day 28).||7.3|-3.1|0.495
72466210|NCT02971228|144455456|OTHER||Median Difference (Final Values)|-8.02||||0.25|TWO_SIDED|95.0|-25.85|10.68|||Wilcoxon (Mann-Whitney)|||Non-parametric method p-value was from a Wilcoxon signed rank text. The normality of the residuals was assessed using the Shapiro-Wilk test, where the residuals were obtained from an ANOVA model with treatment group as the fixed effect. A patient was required to have data for both periods to be included in the pre-specified analysis for a given endpoint.||10.68|-25.85|0.2500
72466211|NCT02971228|144455457|OTHER|A paired t-test was used for the parametric method to compare patients receiving both treatments. A patient was required to have data for both periods to be included in the pre-specified analysis for a given endpoint. Thus, the 2 patients who withdrew from the trial after the Lilly Glucagon treatment before receiving ZP4207 were not included in the analysis.|Mean Difference (Final Values)|-0.28||||0.8508|TWO_SIDED|95.0|-3.55|2.99|||t-test, 2 sided|||A paired t-test or the Wilcoxon signed rank test for comparison of means with normally or non normally distributed residuals, respectively, was used. The Shapiro-Wilk test was used to determine the normality of the residuals for each comparison. The residuals were obtained from an analysis of variance (ANOVA) model with treatment group as the fixed effect. If the p-value of the test was \<0.001, the non-parametric method was utilized to analyze the endpoint parameter.||2.99|-3.55|0.8508
72394517|NCT02310568|144295788|SUPERIORITY_OR_OTHER||LS Mean Difference|2.5|STANDARD_ERROR_OF_MEAN|2.99||0.422|TWO_SIDED|90.0|-2.7|7.6|||Mixed-Effects Model Repeated Measure|||(PF-06372865 2.5 mg - Placebo). Week 6: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 2 was Week 4 (Day 28).||7.6|-2.7|0.422
72394518|NCT02310568|144295788|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|2.65||0.889|TWO_SIDED|90.0|-5.0|4.2|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 6: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 2 was Week 4 (Day 28).||4.2|-5.0|0.889
72394519|NCT02310568|144295788|SUPERIORITY_OR_OTHER||LS Mean Difference|2.7|STANDARD_ERROR_OF_MEAN|2.71||0.324||90.0|-2.0|7.4|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - Placebo). Week 7: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 2 was Week 4 (Day 28).||7.4|-2.0|0.324
72394520|NCT02310568|144295788|SUPERIORITY_OR_OTHER||LS Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|2.69||0.939|TWO_SIDED|90.0|-4.5|4.9|||Mixed-Effects Model Repeated Measure|||(PF-06372865 2.5 mg - Placebo). Week 7: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 2 was Week 4 (Day 28).||4.9|-4.5|0.939
72394521|NCT02310568|144295788|SUPERIORITY_OR_OTHER||LS Mean Difference|2.5|STANDARD_ERROR_OF_MEAN|2.42||0.308|TWO_SIDED|90.0|-1.7|6.7|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 7: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 2 was Week 4 (Day 28).||6.7|-1.7|0.308
72466212|NCT02971228|144455457|OTHER||Median Difference (Final Values)|0.03|||>|0.9999|TWO_SIDED|95.0|-4.12|3.13|||Wilcoxon (Mann-Whitney)|||Non-parametric method p-value was from a Wilcoxon signed rank text. The normality of the residuals was assessed using the Shapiro-Wilk test, where the residuals were obtained from an ANOVA model with treatment group as the fixed effect. A patient was required to have data for both periods to be included in the pre-specified analysis for a given endpoint.||3.13|-4.12|>0.9999
72466213|NCT02971228|144455458|OTHER|A paired t-test was used for the parametric method to compare patients receiving both treatments. A patient was required to have data for both periods to be included in the pre-specified analysis for a given endpoint. Thus, the 2 patients who withdrew from the trial after the Lilly Glucagon treatment before receiving ZP4207 were not included in the analysis.|Mean Difference (Final Values)|0.63||||0.1847|TWO_SIDED|95.0|-0.36|1.62|||t-test, 2 sided|||A paired t-test or the Wilcoxon signed rank test for comparison of means with normally or non normally distributed residuals, respectively, was used. The Shapiro-Wilk test was used to determine the normality of the residuals for each comparison. The residuals were obtained from an analysis of variance (ANOVA) model with treatment group as the fixed effect. If the p-value of the test was \<0.001, the non-parametric method was utilized to analyze the endpoint parameter.||1.62|-0.36|0.1847
72466214|NCT02971228|144455458|OTHER||Median Difference (Final Values)|0.02||||0.0781|TWO_SIDED|95.0|-0.01|3.09|||Wilcoxon (Mann-Whitney)|||Non-parametric method p-value was from a Wilcoxon signed rank text. The normality of the residuals was assessed using the Shapiro-Wilk test, where the residuals were obtained from an ANOVA model with treatment group as the fixed effect. A patient was required to have data for both periods to be included in the pre-specified analysis for a given endpoint.||3.09|-0.01|0.0781
72503312|NCT01009463|144537413|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.85||||0.109|TWO_SIDED|95.0|0.7|1.04|||Generalized Linear Model|Assuming Negative Binomial distribution with logarithm of time on treatment as an offset variable.||||1.04|0.70|0.109
72503313|NCT01009463|144537414|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.92||||0.43|TWO_SIDED|95.0|0.76|1.13|||Regression, Cox|||||1.13|0.76|0.430
72503314|NCT01009463|144537414|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.72||||0.002|TWO_SIDED|95.0|0.59|0.89||Nominal p-value|Regression, Cox|||||0.89|0.59|0.002
72503315|NCT01009463|144537414|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.85||||0.114|TWO_SIDED|95.0|0.69|1.04|||Regression, Cox|||||1.04|0.69|0.114
72503316|NCT01009463|144537415|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.84||||0.125|TWO_SIDED|95.0|0.67|1.05|||Generalized Linear Model|Assuming Negative Binomial distribution with logarithm of time on treatment as an offset variable.||||1.05|0.67|0.125
72503317|NCT01009463|144537415|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.62|||<|0.001|TWO_SIDED|95.0|0.49|0.78||Nominal p-value|Generalized Linear Model|Assuming Negative Binomial distribution with logarithm of time on treatment as an offset variable||||0.78|0.49|<0.001
72503318|NCT01009463|144537415|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.81||||0.064|TWO_SIDED|95.0|0.64|1.01|||Generalized Linear Model|Assuming Negative Binomial distribution with logarithm of time on treatment as an offset variable||||1.01|0.64|0.064
72503319|NCT01009463|144537416|SUPERIORITY_OR_OTHER||Least squares mean difference|0.041||||0.011|TWO_SIDED|95.0|0.009|0.072||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).||||0.072|0.009|0.011
72394522|NCT02310568|144295788|SUPERIORITY_OR_OTHER||LS Mean Difference|0.8|STANDARD_ERROR_OF_MEAN|3.92||0.846|TWO_SIDED|90.0|-6.0|7.6|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - Placebo). Week 8: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 2 was Week 4 (Day 28).||7.6|-6.0|0.846
72394523|NCT02310568|144295788|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.0|STANDARD_ERROR_OF_MEAN|3.89||0.449|TWO_SIDED|90.0|-9.8|3.7|||Mixed-Effects Model Repeated Measure|||(PF-06372865 2.5 mg - Placebo). Week 8: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 2 was Week 4 (Day 28).||3.7|-9.8|0.449
72394524|NCT02310568|144295788|SUPERIORITY_OR_OTHER||LS Mean Difference|3.8|STANDARD_ERROR_OF_MEAN|3.51||0.295|TWO_SIDED|90.0|-2.3|9.9|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 8: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 2 was Week 4 (Day 28).||9.9|-2.3|0.295
72503320|NCT01009463|144537416|SUPERIORITY_OR_OTHER||Least squares mean difference|0.058|||<|0.001|TWO_SIDED|95.0|0.027|0.09||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).||||0.090|0.027|<0.001
72564491|NCT01117766|144660643|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.52|STANDARD_ERROR_OF_MEAN|0.536||0.3404|TWO_SIDED|95.0|-1.61|0.57|||ANCOVA|||Week 4 (Visits 4 and 7)||0.57|-1.61|0.3404
72564492|NCT01117766|144660644|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-12.32|STANDARD_ERROR_OF_MEAN|26.872||0.6539|TWO_SIDED|95.0|-70.2|45.56|||ANCOVA|||Week 3 (Visits 3 and 6)||45.56|-70.20|0.6539
72564493|NCT01117766|144660644|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-23.91|STANDARD_ERROR_OF_MEAN|25.807||0.3678|TWO_SIDED|95.0|-78.54|30.72|||ANCOVA|||Week 4 (Visits 4 and 7)||30.72|-78.54|0.3678
72564494|NCT01117766|144660645|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.09|STANDARD_ERROR_OF_MEAN|0.342||0.0071|TWO_SIDED|95.0|-1.84|-0.35|||ANCOVA|Statistical analysis was based on the average pain score across all levels of stimuli.||Week 3 (Visits 3 and 6)||-0.35|-1.84|0.0071
72564495|NCT01117766|144660645|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.59|STANDARD_ERROR_OF_MEAN|0.37||0.1294|TWO_SIDED|95.0|-1.36|0.19|||ANCOVA|Statistical analysis was based on the average pain score across all levels of stimuli.||Week 4 (Visits 4 and 7)||0.19|-1.36|0.1294
72564496|NCT01117766|144660646|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-61.54|STANDARD_ERROR_OF_MEAN|25.298||0.03|TWO_SIDED|95.0|-116.12|-6.96|||ANCOVA|||Week 3 (Visits 3 and 6)||-6.96|-116.12|0.0300
72564497|NCT01117766|144660646|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-49.06|STANDARD_ERROR_OF_MEAN|26.501||0.0844|TWO_SIDED|95.0|-105.67|7.55|||ANCOVA|||Week 4 (Visits 4 and 7)||7.55|-105.67|0.0844
72564498|NCT01117766|144660647|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.15|STANDARD_ERROR_OF_MEAN|0.478||0.7506|TWO_SIDED|95.0|-0.83|1.14|||ANCOVA|Statistical analysis was based on the average pain score across all levels of stimuli.||Week 3 (Visits 3 and 6)||1.14|-0.83|0.7506
72564499|NCT01117766|144660647|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.01|STANDARD_ERROR_OF_MEAN|0.299||0.9673|TWO_SIDED|95.0|-0.61|0.64|||ANCOVA|Statistical analysis was based on the average pain score across all levels of stimuli.||Week 4 (Visits 4 and 7)||0.64|-0.61|0.9673
72621667|NCT04526158|144773622|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.736|TWO_SIDED|95.0|-0.2|0.3|||Mixed Models Analysis|Linear mixed model adjusted for baseline values of BPI intensity, Pain Self-Efficacy, and design factors|estimates were generated from multiple imputed data|||0.3|-0.2|0.736
72503321|NCT01009463|144537416|SUPERIORITY_OR_OTHER||Least squares mean difference|0.064|||<|0.001|TWO_SIDED|95.0|0.033|0.096||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).||||0.096|0.033|<0.001
72503322|NCT02413255|144537425|EQUIVALENCE|Dose proportionality is declared when the 90% confidence interval of the slope lies entirely within the critical region (0.9679, 1.0321) for the dose range of 0.1 mg to 105 mg.|Slope|1.0195||||0.465|TWO_SIDED|90.0|0.9752|1.0637|||Power Model|||||1.0637|0.9752|0.465
72503323|NCT02413255|144537426|EQUIVALENCE|Dose proportionality is declared when the 90% confidence interval of the slope lies entirely within the critical region (0.9679, 1.0321) for the dose range of 0.1 mg to 105 mg.|Slope|1.1124||||0.126|TWO_SIDED|90.0|0.9913|1.2336|||Power Model|||Day 1||1.2336|0.9913|0.126
72564500|NCT01117766|144660648|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.39|STANDARD_ERROR_OF_MEAN|0.642||0.5502|TWO_SIDED|95.0|-0.99|1.78|||ANCOVA|Statistical analysis was based on the average pain score across all levels of stimuli.||Week 3 (Visits 3 and 6)||1.78|-0.99|0.5502
72564501|NCT01117766|144660648|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.09|STANDARD_ERROR_OF_MEAN|0.5||0.8536|TWO_SIDED|95.0|-1.15|0.96|||ANCOVA|Statistical analysis was based on the average pain score across all levels of stimuli.||Week 4 (Visits 4 and 7)||0.96|-1.15|0.8536
72564502|NCT01117766|144660649|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.54|STANDARD_ERROR_OF_MEAN|0.586||0.0132|TWO_SIDED|95.0|-2.73|-0.34|||ANCOVA||In statistical analyses, scores were further grouped to 1-3 'improved', 4 'no change' and 5-7 'worsened'.|Week 3 (Visits 3 and 6)||-0.34|-2.73|0.0132
72564503|NCT01117766|144660649|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.0|STANDARD_ERROR_OF_MEAN|0.467||0.0403|TWO_SIDED|95.0|-1.95|-0.05|||ANCOVA||In statistical analyses, scores were further grouped to 1-3 'improved', 4 'no change' and 5-7 'worsened'.|Week 4 (Visits 4 and 7)||-0.05|-1.95|0.0403
72564504|NCT01117766|144660650|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.19|STANDARD_ERROR_OF_MEAN|0.433||0.6631|TWO_SIDED|95.0|-1.12|0.74|||ANCOVA|||Week 3 (Visits 3 and 6)||0.74|-1.12|0.6631
72564505|NCT01117766|144660650|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.54|STANDARD_ERROR_OF_MEAN|0.465||0.0022|TWO_SIDED|95.0|-2.48|-0.59|||ANCOVA|||Week 4 (Visits 4 and 7)||-0.59|-2.48|0.0022
72564506|NCT01117766|144660651|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.04|STANDARD_ERROR_OF_MEAN|0.722||0.1753|TWO_SIDED|95.0|-2.6|0.53|||ANCOVA|||Week 3 (Visits 3 and 6)||0.53|-2.60|0.1753
72564507|NCT01117766|144660651|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.51|STANDARD_ERROR_OF_MEAN|0.588||0.0198|TWO_SIDED|95.0|-2.75|-0.27|||ANCOVA|||Week 4 (Visits 4 and 7)||-0.27|-2.75|0.0198
72564508|NCT01117766|144660652|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.29|STANDARD_ERROR_OF_MEAN|6.292||0.4999|TWO_SIDED|95.0|-17.13|8.54|||ANCOVA|||||8.54|-17.13|0.4999
72564509|NCT00438659|144660653|SUPERIORITY_OR_OTHER|||||||0.18|||||||t-test, 2 sided|||||||0.18
72564510|NCT03069417|144660662|SUPERIORITY|Conducted at post-treatment time point.||||||0.11|||||||Mixed Models Analysis|||||||0.11
72564511|NCT03069417|144660662|SUPERIORITY|Conducted at 3-month follow-up time point.||||||0.56|||||||Mixed Models Analysis|||||||0.56
72564512|NCT03069417|144660663|SUPERIORITY|Main effect for time calculated at 3-month follow-up time point.|Fixed effects coefficient (β)|-12.7|||<|0.05|TWO_SIDED|95.0|-22.29|-3.15||The threshold for statistical significance was p = 0.05.|Mixed Models Analysis|||||-3.15|-22.29|< 0.05
72564513|NCT03069417|144660664|SUPERIORITY|Interaction evaluated at post-treatment time point.|Fixed effects coefficient (β)|-11.1|||<|0.005|TWO_SIDED|95.0|-18.41|-3.83||The threshold for statistical significance was p = 0.05.|Mixed Models Analysis|||||-3.83|-18.41|< 0.005
72564514|NCT03069417|144660664|SUPERIORITY|Main effect for time at 3-month follow-up time point.|Fixed effects coefficient (β)|-13.8|||<|0.005|TWO_SIDED|95.0|-22.5|-5.17||The threshold for statistical significance was p = 0.05.|Mixed Models Analysis|||||-5.17|-22.50|< 0.005
72621668|NCT04526158|144773622|SUPERIORITY||Mean Difference (Final Values)|-0.4|||<|0.001|TWO_SIDED|95.0|-0.6|-0.2|||Mixed Models Analysis|Linear mixed model adjusted for baseline values of BPI intensity, Pain Self-Efficacy, and design factors|estimates were generated from multiple imputed data|||-0.2|-0.6|<0.001
72394525|NCT02310568|144295790|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|1.72||0.514|TWO_SIDED|90.0|-4.0|1.7|||ANCOVA|||(PF-06372865 7.5 mg - Placebo). Total Score (Week 4): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.||1.7|-4.0|0.514
72466215|NCT00241969|144455494|SUPERIORITY|Some data were missing for energy intake (n=3 baseline, n=13 post-treatment), thus the PROC MIXED procedure (SAS) with maximum likelihood estimation was used to analyze this outcome with time as a repeated measure factor.|maximum likelihood estimation|431.0|||<|0.001|TWO_SIDED|95.0|282.0|581.0|||ANCOVA||||All analyses were performed on the full intention-to-treat sample (defined a priori as attending the first treatment session). Some data were missing for energy intake (N = 3 baseline; 13 post treatment), and thus the PROC MIXED procedure (SAS) with maximum likelihood estimation was used to analyze this outcome with time as a repeated measures factor, no group main effect at baseline for energy intake, and sex, baseline Pseudomonas aeruginosa status, and treatment modality as covariates in the statistical model. This model is similar to an analysis of covariance model with baseline energy intake included as an additional covariate, but the PROC MIXED model employs maximum likelihood estimation and consequently allows for data to be missing at random. The test of the time by group interaction within this PROC MIXED model indicated whether the behavioral and nutrition treatment was efficacious relative to our control treatment.|581|282|<0.001
72466216|NCT00241969|144455495|SUPERIORITY|All analyses were performed on the full intention-to-treat sample (defined a priori as attending the first treatment session). Analyses of WAZ change scores were carried out within the PROC GLM procedure (SAS Institute Inc.) using an analysis of covariance model with sex, Pseudomonas aeruginosa status at baseline, treatment modality, and baseline value of the corresponding outcome variable as covariates.|maximum likelihood|0.09||||0.25|TWO_SIDED|95.0|-0.06|0.24|||ANCOVA||||All analyses were performed on the full intention-to-treat sample (defined a priori as attending the first treatment session). Analyses of WAZ change scores were carried out within the PROC GLM procedure (SAS Institute Inc.) using an analysis of covariance model with sex, Pseudomonas aeruginosa status at baseline, treatment modality, and baseline value of the corresponding outcome variable as covariates. Group main effects on these change scores in the presence of covariates were examined to determine the efficacy of the behavioral and nutrition treatment.|0.24|-0.06|0.25
72394526|NCT02310568|144295790|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.7|STANDARD_ERROR_OF_MEAN|1.65||0.302|TWO_SIDED|90.0|-4.5|1.0|||ANCOVA|||(PF-06372865 2.5 mg - Placebo). Total Score (Week 4): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.||1.0|-4.5|0.302
72466217|NCT00241969|144455496|SUPERIORITY|All analyses were performed on the full intention-to-treat sample (defined a priori as attending the first treatment session). Analyses of HAZ change scores were carried out within the PROC GLM procedure (SAS Institute Inc.) using an analysis of covariance model with sex, Pseudomonas aeruginosa status at baseline, treatment modality, and baseline value of the corresponding outcome variable as covariates.|maximum likelihood|0.14||||0.049|TWO_SIDED|95.0|0.001|0.27|||ANCOVA||||All analyses were performed on the full intention-to-treat sample (defined a priori as attending the first treatment session). Analyses of WAZ and HAZ change scores were carried out within the PROC GLM procedure (SAS Institute Inc.) using an analysis of covariance model with sex, Pseudomonas aeruginosa status at baseline, treatment modality, and baseline value of the corresponding outcome variable as covariates. Group main effects on these change scores in the presence of covariates were examined to determine the efficacy of the behavioral and nutrition treatment.|0.27|0.001|0.049
72466218|NCT01013740|144455507|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.84||||||95.0|0.53|1.35|||||The Pike estimator of the treatment HR was based on the log rank test.|||1.35|0.53|
72466219|NCT01013740|144455512|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.5|||||TWO_SIDED|95.0|0.63|3.58||||||||3.58|0.63|
72466220|NCT00338949|144455516|SUPERIORITY_OR_OTHER_LEGACY|||||||0.228|||||||t-test, 2 sided|||||||0.228
72466221|NCT00338949|144455517|SUPERIORITY_OR_OTHER_LEGACY|||||||0.958|||||||t-test, 2 sided|||||||0.958
72466222|NCT00582114|144455527|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.36||||0.001|TWO_SIDED|95.0|1.36|4.23|||Mixed Models Analysis|||Cardiovascular events were counted by subject and included the following: myocardial infarction, stroke, hospitalization for congestive heart failure, hospitalized angina, arrhythmias, cardiac arrest, coronary revascularization and heart valve replacement. The duration of participation in the study per subject, which according to the trial design could be up to 12 months, was determined. Incidence rate ratio (IRR) by treatment was then determined along with the 95%confidence intervals (95% CIs).||4.23|1.36|0.001
72466223|NCT00582114|144455527|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.29||||0.02|TWO_SIDED|95.0|1.07|5.21|||Mixed Models Analysis|||As a post hoc analysis, we determined the narrower definition of cardiovascular events per group that included myocardial infarction, stroke, congestive heart failure or cardiovascular death. The duration of participation in the study per subject, which according to the trial design could be up to 12 months, was determined. Incidence rate ratio (IRR) by treatment was then determined along with the 95%confidence intervals (95% CIs).||5.21|1.07|0.02
72466224|NCT00582114|144455527|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|3.13||||0.02|TWO_SIDED|95.0|1.08|10.99|||Mixed Models Analysis|||Hospitalization for congestive heart failure between groups was analyzed. The duration of participation in the study per subject, which according to the trial design could be up to 12 months, was determined. Incidence rate ratio (IRR) by treatment was then determined along with the 95%confidence intervals.||10.99|1.08|0.02
72564515|NCT03069417|144660666|SUPERIORITY|Main effect for condition.|Fixed effects coefficient (β)|-10.1|||<|0.05|TWO_SIDED|95.0|-19.58|-0.67||The threshold for statistical significance was p = 0.05.|Mixed Models Analysis|||||-0.67|-19.58|< 0.05
72564516|NCT03069417|144660666|SUPERIORITY|Main effect for time at post-treatment time point.|Fixed effects coefficient (β)|-12.8|||<|0.01|TWO_SIDED|95.0|-22.14|-3.37||The threshold for statistical significance was p = 0.05.|Mixed Models Analysis|||||-3.37|-22.14|< 0.01
72564517|NCT03069417|144660667|SUPERIORITY|Main effect for condition.|Fixed effects coefficient (β)|6.2|||<|0.05|TWO_SIDED|95.0|0.5|11.88||The threshold for statistical significance was p = 0.05.|Mixed Models Analysis|||||11.88|0.50|< 0.05
72466225|NCT00582114|144455527|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.61||||0.002|TWO_SIDED|95.0|1.18|2.19|||Mixed Models Analysis|||All-cause hospitalizations between groups were analyzed. The duration of participation in the study per subject, which according to the trial design could be up to 12 months, was determined. Incidence rate ratio (IRR) by treatment was then determined along with the 95%confidence intervals.||2.19|1.18|0.002
72466226|NCT02604342|144455528|SUPERIORITY||Hazard Ratio (HR)|0.2|||<|0.001|TWO_SIDED|95.0|0.12|0.33|||Stratified log-rank test||Estimated hazard ratio obtained from stratified Cox model with treatment group as covariate.|||0.33|0.12|<0.001
72466227|NCT02604342|144455529|SUPERIORITY||Difference in C-ORR|0.667|||<|0.001|TWO_SIDED|95.0|0.39|0.86|||Chi-squared|||95% confidence interval of the difference (alectinib - chemotherapy) computed using Hauck-Anderson approach.||0.86|0.39|<0.001
72466228|NCT00130728|144455552|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.97||||0.7583||95.0|0.799|1.177||relative to placebo arm|Log Rank||Stratified analysis; Hazard ratio is relative to placebo arm.|||1.177|0.799|0.7583
72466229|NCT00130728|144455553|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.623|||<|0.0001||95.0|0.519|0.748||relative to placebo arm|Log Rank||Stratified analysis; hazard ratio is relative to placebo arm.|||0.748|0.519|<.0001
72466230|NCT00130728|144455554|SUPERIORITY_OR_OTHER_LEGACY||Percentage difference|6.4||||0.0068||95.0|1.8|11.3||Relative to placebo arm|Mantel Haenszel||Difference in objective response rates relative to placebo arm|||11.3|1.8|0.0068
72503324|NCT02413255|144537426|EQUIVALENCE|Dose proportionality is declared when the 90% confidence interval of the slope lies entirely within the critical region (0.9679, 1.0321) for the dose range of 0.1 mg to 105 mg.|Slope|1.09||||0.114|TWO_SIDED|90.0|0.9962|1.1838|||Power Model|||Day 9||1.1838|0.9962|0.114
72503325|NCT02413255|144537427|SUPERIORITY|||||||0.5402|||||||ANOVA|Statistical analysis results were obtained using Analysis of Variance (ANOVA) with dose level as a fixed effect.||||||0.5402
72503326|NCT02413255|144537428|SUPERIORITY|||||||0.7824|||||||ANOVA|Statistical analysis results were obtained using ANOVA with dose level as a fixed effect.||Day 1||||0.7824
72503327|NCT02413255|144537428|SUPERIORITY|||||||0.4056|||||||ANOVA|Statistical analysis results were obtained using ANOVA with dose level as a fixed effect.||Day 9||||0.4056
72503328|NCT02413255|144537429|EQUIVALENCE|Dose proportionality is declared when the 90% confidence interval of the slope lies entirely within the critical region (0.9679, 1.0321) for the dose range of 0.1 mg to 105 mg.|Slope|1.0606||||0.019|TWO_SIDED|90.0|1.0187|1.1026|||Power Model|||||1.1026|1.0187|0.019
72503329|NCT02413255|144537430|EQUIVALENCE|Dose proportionality is declared when the 90% confidence interval of the slope lies entirely within the critical region (0.9679, 1.0321) for the dose range of 0.1 mg to 105 mg.|Slope|1.0789||||0.258|TWO_SIDED|90.0|0.9628|1.195|||Power Model|||Day 1||1.1950|0.9628|0.258
72503330|NCT02413255|144537430|EQUIVALENCE|Dose proportionality is declared when the 90% confidence interval of the slope lies entirely within the critical region (0.9679, 1.0321) for the dose range of 0.1 mg to 105 mg.|Slope|1.0929||||0.144|TWO_SIDED|90.0|0.9878|1.198|||Power Model|||Day 9||1.1980|0.9878|0.144
72503331|NCT02413255|144537433|EQUIVALENCE|Dose proportionality is declared when the 90% confidence interval of the slope lies entirely within the critical region (0.9679, 1.0321) for the dose range of 0.1 mg to 105 mg.|Slope|1.0799||||0.003|TWO_SIDED|90.0|1.0371|1.1227|||Power Model|||||1.1227|1.0371|0.003
72621669|NCT04526158|144773622|SUPERIORITY||Mean Difference (Final Values)|-0.4|||<|0.001|TWO_SIDED|95.0|-0.7|-0.2|||Mixed Models Analysis|Linear mixed model adjusted for baseline values of BPI intensity, Pain Self-Efficacy, and design factors|estimates were generated from multiple imputed data|||-0.2|-0.7|<0.001
72466231|NCT00746356|144455563|NON_INFERIORITY_OR_EQUIVALENCE|Sample size was calculated for an 80% power to reject the null hypothesis at 1.67% significance level.|Mean Difference (Final Values)|0.0066|STANDARD_DEVIATION|0.3103|<|0.0001|ONE_SIDED|95.0|-0.25|||P-value was adjusted for multiple efficacy endpoints. If all three primary effectiveness endpoints were met a value of 5% was used, if two were met a value of 2.5% was used, and if one was met a value of 1.67% was used.|t-test, 1 sided|If the data is not normally distributed, then the Wilcoxon signed rank test will be used to perform the two one-sided testing.||The null hypothesis was rejected at significance level 1.67% if the mean difference between the automatic test and the manual test was \<0.25 volts.|||-0.25|<0.0001
72503332|NCT02413255|144537434|EQUIVALENCE|Dose proportionality is declared when the 90% confidence interval of the slope lies entirely within the critical region (0.9679, 1.0321) for the dose range of 0.1 mg to 105 mg.|Slope|1.0897||||0.201|TWO_SIDED|90.0|0.9735|1.206|||Power Model|||||1.2060|0.9735|0.201
72503333|NCT02413255|144537435|EQUIVALENCE|Dose proportionality is declared when the 90% confidence interval of the slope lies entirely within the critical region (0.9679, 1.0321) for the dose range of 0.1 mg to 105 mg.|Slope|1.0188||||0.49|TWO_SIDED|90.0|0.9734|1.0642|||Power Model|||||1.0642|0.9734|0.490
72503334|NCT02413255|144537436|EQUIVALENCE|Dose proportionality is declared when the 90% confidence interval of the slope lies entirely within the critical region (0.9679, 1.0321) for the dose range of 0.1 mg to 105 mg.|Slope|1.0846||||0.224|TWO_SIDED|90.0|0.969|1.2002|||Power Model|||||1.2002|0.9690|0.224
72503335|NCT02413255|144537443|SUPERIORITY||||||<|0.0001|||||||ANOVA|Statistical analysis results were obtained using ANOVA with dose level as a fixed effect.||||||<.0001
72503336|NCT02413255|144537459|OTHER||Estimated Ratio|1.121|||||TWO_SIDED|90.0|0.772|1.628||||||||1.628|0.772|
72503337|NCT02413255|144537459|OTHER||Estimated Ratio|1.156|||||TWO_SIDED|90.0|0.796|1.678||||||||1.678|0.796|
72503338|NCT02413255|144537459|OTHER||Estimated Ratio|0.982|||||TWO_SIDED|90.0|0.676|1.425||||||||1.425|0.676|
72503339|NCT02413255|144537459|OTHER||Estimated Ratio|1.055|||||TWO_SIDED|90.0|0.701|1.587||||||||1.587|0.701|
72503340|NCT02413255|144537459|OTHER||Estimated Ratio|1.105|||||TWO_SIDED|90.0|0.761|1.604||||||||1.604|0.761|
72503341|NCT02413255|144537459|OTHER||Estimated Ratio|1.225|||||TWO_SIDED|90.0|0.844|1.778||||||||1.778|0.844|
72503342|NCT02333331|144537460|SUPERIORITY||Mean Difference (Final Values)|0.28||||0.274|TWO_SIDED|95.0|-0.64|1.21|||Mixed Models Analysis|||||1.21|-0.64|0.274
72503343|NCT02333331|144537460|SUPERIORITY||Mean Difference (Final Values)|0.26||||0.32|TWO_SIDED|95.0|-0.83|1.35|||Mixed Models Analysis|||||1.35|-0.83|0.320
72621670|NCT04526158|144773623|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.829|TWO_SIDED|95.0|-0.4|0.4|||Mixed Models Analysis|Linear mixed model adjusted for baseline values of PROMIS Physical function, Pain Self-Efficacy, and design factors|estimates were generated from multiple imputed data|||0.4|-0.4|0.829
72466232|NCT00746356|144455564|NON_INFERIORITY_OR_EQUIVALENCE|Sample size was calculated for an 80% power to reject the null hypothesis at 1.67% significance level.|Mean Difference (Final Values)|-0.0625|STANDARD_DEVIATION|0.0948||0.0001|ONE_SIDED|95.0|-0.25|||P-value was adjusted for multiple efficacy endpoints. If all three primary effectiveness endpoints were met a value of 5% was used, if two were met a value of 2.5% was used and if one was met a value of 1.67% was used.|t-test, 1 sided|If the data is not normally distributed, then the Wilcoxon signed rank test will be used to perform the two one-sided testing.||The null hypothesis was rejected at significance level 1.67% if the mean difference between the automatic test and the manual test was \<0.25 volts.|||-0.25|0.0001
72466233|NCT00746356|144455565|NON_INFERIORITY_OR_EQUIVALENCE|Sample size was calculated for an 80% power to reject the null hypothesis at 1.67% significance level.|Mean Difference (Final Values)|-0.0556|STANDARD_DEVIATION|0.0824||0.0001|ONE_SIDED|95.0|-0.25|||P-value was adjusted for multiple efficacy endpoints. If all three primary effectiveness endpoints were met a value of 5% was used, if two were met, a value of 2.5% were used and if one was met a value of 1.67% was used.|t-test, 1 sided|If the data is not normally distributed, then the Wilcoxon signed rank test will be used to perform the two one-sided testing.||The null hypothesis was rejected at significance level 1.67% if the mean difference between the automatic test and the manual test was \<0.25 volts.|||-0.25|0.0001
72503344|NCT02333331|144537460|SUPERIORITY||Mean Difference (Final Values)|0.31||||0.134|TWO_SIDED|95.0|-0.24|0.87|||Mixed Models Analysis|||||0.87|-0.24|0.134
72621671|NCT04526158|144773623|SUPERIORITY||Mean Difference (Final Values)|0.5||||0.005|TWO_SIDED|95.0|0.2|0.9|||Mixed Models Analysis|Linear mixed model adjusted for baseline values of PROMIS Physical function, Pain Self-Efficacy, and design factors|estimates were generated from multiple imputed data|||0.9|0.2|0.005
72503345|NCT02333331|144537461|SUPERIORITY||Mean Difference (Final Values)|-3.32||||0.576|TWO_SIDED|95.0|-37.6|30.95|||Mixed Models Analysis|||||30.95|-37.6|0.576
72503346|NCT02333331|144537461|SUPERIORITY||Mean Difference (Final Values)|19.6||||0.178|TWO_SIDED|95.0|-22.2|61.41|||Mixed Models Analysis|||||61.41|-22.2|0.178
72503347|NCT02333331|144537461|SUPERIORITY||Mean Difference (Final Values)|10.31||||0.163|TWO_SIDED|95.0|-10.4|30.98|||Mixed Models Analysis|||||30.98|-10.4|0.163
72503348|NCT02333331|144537462|SUPERIORITY||Mean Difference (Net)|0.0||||0.488|TWO_SIDED|95.0|-0.1|0.1|||Mixed Models Analysis|||||0.10|-0.10|0.488
72621672|NCT04526158|144773623|SUPERIORITY||Mean Difference (Final Values)|0.6||||0.004|TWO_SIDED|95.0|0.2|1.0|||Mixed Models Analysis|Linear mixed model adjusted for baseline values of PROMIS Physical function, Pain Self-Efficacy, and design factors|estimates were generated from multiple imputed data|||1.0|0.2|0.004
72621673|NCT04526158|144773624|SUPERIORITY||Mean Difference (Final Values)|0.4||||0.079|TWO_SIDED|95.0|0.0|0.8|||Mixed Models Analysis|Linear mixed model adjusted for baseline values of PROMIS Anxiety, Pain Self-Efficacy, and design factors|estimates were generated from multiple imputed data|||0.8|0.0|0.079
72621674|NCT04526158|144773624|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.296|TWO_SIDED|95.0|-0.6|0.2|||Mixed Models Analysis|Linear mixed model adjusted for baseline values of PROMIS Anxiety, Pain Self-Efficacy, and design factors|estimates were generated from multiple imputed data|||0.2|-0.6|0.296
72621675|NCT04526158|144773624|SUPERIORITY||Mean Difference (Final Values)|-0.6||||0.005|TWO_SIDED|95.0|-1.0|-0.2|||Mixed Models Analysis|Linear mixed model adjusted for baseline values of PROMIS Anxiety, Pain Self-Efficacy, and design factors|estimates were generated from multiple imputed data|||-0.2|-1.0|0.005
72621676|NCT04526158|144773625|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.464|TWO_SIDED|95.0|-0.3|0.7|||Mixed Models Analysis|Linear mixed model adjusted for baseline values of PROMIS fatigue, Pain Self-Efficacy, and design factors|estimates were generated from multiple imputed data|||0.7|-0.3|0.464
72621677|NCT04526158|144773625|SUPERIORITY||Mean Difference (Final Values)|-0.6||||0.019|TWO_SIDED|95.0|-1.1|-0.1|||Mixed Models Analysis|Linear mixed model adjusted for baseline values of PROMIS fatigue, Pain Self-Efficacy, and design factors|estimates were generated from multiple imputed data|||-0.1|-1.1|0.019
72621678|NCT04526158|144773625|SUPERIORITY||Mean Difference (Final Values)|-0.8||||0.002|TWO_SIDED|95.0|-1.3|-0.3|||Mixed Models Analysis|Linear mixed model adjusted for baseline values of PROMIS fatigue, Pain Self-Efficacy, and design factors|estimates were generated from multiple imputed data|||-0.3|-1.3|0.002
72621679|NCT04526158|144773626|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.889|TWO_SIDED|95.0|-0.5|0.4|||Mixed Models Analysis|Linear mixed model adjusted for baseline values of PROMIS sleep disturbance, Pain Self-Efficacy, and design factors|estimates were generated from multiple imputed data|||0.4|-0.5|0.889
72503349|NCT02333331|144537462|SUPERIORITY||Mean Difference (Net)|0.1||||0.055|TWO_SIDED|95.0|-0.02|0.22|||Mixed Models Analysis|||||0.22|-0.02|0.055
72621680|NCT04526158|144773626|SUPERIORITY||Mean Difference (Final Values)|-0.7||||0.004|TWO_SIDED|95.0|-1.1|-0.2|||Mixed Models Analysis|Linear mixed model adjusted for baseline values of PROMIS sleep disturbance, Pain Self-Efficacy, and design factors|estimates were generated from multiple imputed data|||-0.2|-1.1|0.004
72621681|NCT04526158|144773626|SUPERIORITY||Mean Difference (Final Values)|-0.6||||0.006|TWO_SIDED|95.0|-1.1|-0.2|||Mixed Models Analysis|Linear mixed model adjusted for baseline values of PROMIS sleep disturbance, Pain Self-Efficacy, and design factors|estimates were generated from multiple imputed data|||-0.2|-1.1|0.006
72621682|NCT04526158|144773627|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.76|TWO_SIDED|95.0|-0.4|0.5|||Mixed Models Analysis|Linear mixed model adjusted for baseline values of PROMIS social roles and activities, Pain Self-Efficacy, and design factors|estimates were generated from multiple imputed data|||0.5|-0.4|0.76
72621683|NCT04526158|144773627|SUPERIORITY||Mean Difference (Final Values)|1.0|||<|0.001|TWO_SIDED|95.0|0.6|1.4|||Mixed Models Analysis|Linear mixed model adjusted for baseline values of PROMIS social roles and activities, Pain Self-Efficacy, and design factors|estimates were generated from multiple imputed data|||1.4|0.6|<0.001
72621684|NCT04526158|144773627|SUPERIORITY||Mean Difference (Final Values)|0.9|||<|0.001|TWO_SIDED|95.0|0.5|1.3|||Mixed Models Analysis|Linear mixed model adjusted for baseline values of PROMIS social roles and activities, Pain Self-Efficacy, and design factors|estimates were generated from multiple imputed data|||1.3|0.5|<0.001
72621685|NCT04526158|144773628|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.89|TWO_SIDED|95.0|-0.7|0.6|||Mixed Models Analysis|Linear mixed model adjusted for baseline values of PHQ8, Pain Self-Efficacy, and design factors|estimates were generated from multiple imputed data|||0.6|-0.7|0.89
72466234|NCT00746356|144455566|NON_INFERIORITY_OR_EQUIVALENCE|Sample size was calculated for an 80% power to reject the null hypothesis at 1.67% significance level.|Mean Difference (Final Values)|0.0028|STANDARD_DEVIATION|0.2852||0.0001|ONE_SIDED|95.0|-0.25|||P-value was adjusted for multiple efficacy endpoints. If three primary effectiveness endpoints were met a value of 5% was used, if two were met a value of 2.5% was used and if one was met a value of 1.67% was used.|t-test, 1 sided|If the data is not normally distributed, then the Wilcoxon signed rank test will be used to perform the two one-sided testing.||The null hypothesis was rejected at significance level 1.67% if the mean difference between the automatic test and the manual test was \<0.25 volts.|||-0.25|0.0001
72503350|NCT02333331|144537462|SUPERIORITY||Mean Difference (Net)|0.03||||0.161|TWO_SIDED|95.0|-0.03|0.09|||Mixed Models Analysis|||||0.09|-0.03|0.161
72503351|NCT02333331|144537463|SUPERIORITY||Mean Difference (Net)|1.01||||0.213|TWO_SIDED|95.0|0.99|1.03|||Mixed Models Analysis|||||1.03|0.99|0.213
72503352|NCT02333331|144537463|SUPERIORITY||Mean Difference (Net)|1.06|||<|0.001|TWO_SIDED|95.0|1.03|1.09|||Mixed Models Analysis|||||1.09|1.03|<0.001
72564518|NCT04117945|144660672|SUPERIORITY|||||||0.8874|||||||One-sided unstratified log-rank|||||||0.8874
72503353|NCT02333331|144537463|SUPERIORITY||Mean Difference (Net)|1.06|||<|0.001|TWO_SIDED|95.0|1.05|1.08|||Mixed Models Analysis|||||1.08|1.05|<0.001
72503354|NCT02333331|144537464|SUPERIORITY||Mean Difference (Net)|1.0||||0.458|TWO_SIDED|95.0|0.98|1.02|||Mixed Models Analysis|||||1.02|0.98|0.458
72503355|NCT02333331|144537464|SUPERIORITY||Mean Difference (Net)|1.05|||<|0.001|TWO_SIDED|95.0|1.03|1.08|||Mixed Models Analysis|||||1.08|1.03|<0.001
72503356|NCT02333331|144537464|SUPERIORITY||Mean Difference (Net)|1.06|||<|0.001|TWO_SIDED|95.0|1.04|1.07|||Mixed Models Analysis|||||1.07|1.04|<0.001
72503357|NCT01494038|144537465|NON_INFERIORITY|Calculate the difference between the immediate arm incidence rate and the deferred arm incidence rate; if the upper bound of the 95% confidence interval is lower than a 5% difference in incidence rates, non-inferiority will be considered to be proven.|Incidence rate difference|0.1|||||TWO_SIDED|95.0|-4.77|4.98||||||||4.98|-4.77|
72503358|NCT01494038|144537466|SUPERIORITY|||||||0.093|||||||Fisher Exact|mid-P adjustment||||||0.093
72564519|NCT04117945|144660673|SUPERIORITY|||||||0.9683|||||||One-sided unstratified log-rank|||||||0.9683
72370698|NCT00488683|144251642|SUPERIORITY_OR_OTHER||R-square|0.21||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between demographic factors memory B cells one month after primary vaccination and serogroup specific IgG concentration at 12 months of age for the serogroup W-135||||
72370699|NCT00488683|144251642|SUPERIORITY_OR_OTHER||R-square|0.39||||||95.0|||||Regression, Linear|||Linear regression coefficient between demographic factors memory B cells one month after primary vaccination and serogroup specific IgG concentration at 12 months of age for the serogroup Y||||
72370700|NCT00488683|144251642|SUPERIORITY_OR_OTHER||R-square|0.33||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between demographic factors memory B cells one month after primary vaccination and serogroup specific IgG concentration at 12 months of age for the serogroup Y||||
72503359|NCT01494038|144537468|SUPERIORITY|||||||0.288|||||||Fisher Exact|mid-P adjustment||||||0.288
72503360|NCT01494038|144537469|SUPERIORITY|||||||0.073|||||||Fisher Exact|mid-P adjustment||||||0.073
72503361|NCT01494038|144537470|SUPERIORITY|||||||0.264|||||||Fisher Exact|mid-P adjustment||||||0.264
72503362|NCT01494038|144537471|SUPERIORITY|||||||0.012|||||||Fisher Exact|Mid-P adjustment||||||0.012
72503363|NCT01494038|144537474|SUPERIORITY|||||||0.279|||||||Fisher Exact|mid-P adjustment||||||0.279
72503364|NCT01494038|144537475|SUPERIORITY|||||||0.893|||||||Fisher Exact|mid-P adjustment||||||.893
72503365|NCT01494038|144537476|SUPERIORITY||Incidence rate difference|0.01|||||TWO_SIDED|95.0|-0.94|0.96||||||||0.96|-0.94|
72503366|NCT01494038|144537477|SUPERIORITY||Incidence rate difference|0.02|||||TWO_SIDED|95.0|-1.02|1.07||||||||1.07|-1.02|
72503367|NCT01494038|144537478|SUPERIORITY||Incidence rate difference|-1.43|||||TWO_SIDED|95.0|-4.17|1.32||||||||1.32|-4.17|
72503368|NCT01494038|144537479|SUPERIORITY||Incidence rate difference|-0.39|||||TWO_SIDED|95.0|-1.33|0.56||||||||0.56|-1.33|
72503369|NCT01494038|144537480|SUPERIORITY||Incidence rate difference|-0.38|||||TWO_SIDED|95.0|-1.72|0.97||||||||0.97|-1.72|
72503370|NCT01494038|144537481|SUPERIORITY||Incidence rate difference|-1.69|||||TWO_SIDED|95.0|-4.48|1.1||||||||1.1|-4.48|
72503371|NCT01494038|144537482|SUPERIORITY||Incidence rate difference|-1.3|||||TWO_SIDED|95.0|-3.86|1.25||||||||1.25|-3.86|
72503372|NCT01494038|144537483|SUPERIORITY||Incidence rate difference|2.14|||||TWO_SIDED|95.0|-7.86|12.13||||||||12.13|-7.86|
72503373|NCT01494038|144537484|SUPERIORITY||Incidence rate difference|6.89|||||TWO_SIDED|95.0|-0.08|13.86||||||||13.86|-0.08|
72503374|NCT01494038|144537485|SUPERIORITY||Incidence rate difference|5.49|||||TWO_SIDED|95.0|-13.7|24.68||||||||24.68|-13.7|
72503375|NCT01494038|144537486|SUPERIORITY||Incidence rate difference|15.88|||||TWO_SIDED|95.0|2.11|29.65||||||||29.65|2.11|
72503376|NCT01494038|144537487|SUPERIORITY||Incidence rate difference|-0.82|||||TWO_SIDED|95.0|-4.63|3.0||||||||3|-4.63|
72503377|NCT01494038|144537488|SUPERIORITY||Incidence rate difference|3.38|||||TWO_SIDED|95.0|-1.31|8.07||||||||8.07|-1.31|
72564520|NCT04117945|144660674|SUPERIORITY|||||||0.0448|||||||One-sided unstratified log-rank|||||||0.0448
72564521|NCT04117945|144660675|SUPERIORITY|||||||0.9007|||||||One-sided unstratified log-rank|||||||0.9007
72564522|NCT03535857|144660685|SUPERIORITY||Mean Difference (Final Values)|5.7||||0.546|TWO_SIDED|95.0|||||Pairwise t- test|||||||0.546
72564523|NCT01730040|144660694|SUPERIORITY_OR_OTHER||LS Mean Difference|-39.1|||<|0.0001|TWO_SIDED|99.0|-55.9|-22.2|||Mixed Models Analysis|Threshold for significance ≤ 0.01.||Alirocumab group was compared to the corresponding active control group using an appropriate contrast statement.||-22.2|-55.9|< 0.0001
72564524|NCT01730040|144660694|SUPERIORITY_OR_OTHER||LS Mean Difference|-23.6|||=|0.0004|TWO_SIDED|99.0|-40.7|-6.5||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||As described in statistical analysis 1 of the endpoint.||-6.5|-40.7|= 0.0004
72621686|NCT04526158|144773628|SUPERIORITY||Mean Difference (Final Values)|-0.9||||0.003|TWO_SIDED|95.0|-1.5|-0.3|||Mixed Models Analysis|Linear mixed model adjusted for baseline values of PHQ8, Pain Self-Efficacy, and design factors|estimates were generated from multiple imputed data|||-0.3|-1.5|0.003
72621687|NCT04526158|144773628|SUPERIORITY||Mean Difference (Final Values)|-0.9||||0.007|TWO_SIDED|95.0|-1.5|-0.2|||Mixed Models Analysis|Linear mixed model adjusted for baseline values of PHQ8, Pain Self-Efficacy, and design factors|estimates were generated from multiple imputed data|||-0.2|-1.5|0.007
72621688|NCT04526158|144773629|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.886|TWO_SIDED|95.0|-1.6|1.9|||Mixed Models Analysis|Linear mixed model adjusted for baseline values of PCL5, Pain Self-Efficacy, and design factors|estimates were generated from multiple imputed data|||1.9|-1.6|0.886
72621689|NCT04526158|144773629|SUPERIORITY||Mean Difference (Final Values)|-2.0||||0.017|TWO_SIDED|95.0|-3.7|-0.4|||Mixed Models Analysis|Linear mixed model adjusted for baseline values of PCL5, Pain Self-Efficacy, and design factors|estimates were generated from multiple imputed data|||-0.4|-3.7|0.017
72621690|NCT04526158|144773629|SUPERIORITY||Mean Difference (Final Values)|-2.2||||0.013|TWO_SIDED|95.0|-3.9|-0.5|||Mixed Models Analysis|Linear mixed model adjusted for baseline values of PCL5, Pain Self-Efficacy, and design factors|estimates were generated from multiple imputed data|||-0.5|-3.9|0.013
72621691|NCT04526158|144773630|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.437|TWO_SIDED|95.0|-0.1|0.3|||Mixed Models Analysis|Linear mixed model adjusted for baseline Pain Self-Efficacy, and design factors|estimates were generated from multiple imputed data|||0.3|-0.1|0.437
72466235|NCT01125566|144455579|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.1||||0.4224||95.0|0.87|1.41||Two sided p-value was derived from a log rank test stratified by the setting of prior Trastuzumab failure, hormone receptors status and region of the investigational site.|Regression, Cox||Hazard ratio is derived from Cox proportional hazard model stratified by prior Trastuzumab failure, hormone receptors status and region of the investigational site.|||1.41|0.87|0.4224
72466236|NCT01125566|144455580|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.3||||0.024|TWO_SIDED|95.0|1.03|1.63||Two sided p-value from a log rank test stratified by the setting of prior Trastuzumab failure, hormone receptors status and region of the investigational site.|Regression, Cox||Hazard ratio is derived from Cox proportional hazard model stratified by prior Trastuzumab failure, hormone receptors status and region of the investigational site.|Results of presented analyses are to be seen as exploratory (no confirmatory testing was performed)||1.63|1.03|0.0240
72466237|NCT01125566|144455581|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.09||||0.6431||95.0|0.756|1.572|||Regression, Logistic|Logistic regression stratified by prior Trastuzumab failure, hormone receptors status and region of the investigational site.|The odds ratio for the comparison afatinib + vinorelbine vs. trastuzumab + vinorelbine below 1 favours Afatinib.|Results of presented analyses are to be seen as exploratory (no confirmatory testing was performed)||1.572|0.756|0.6431
72466238|NCT01125566|144455582|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.029||||0.8829||95.0|0.707|1.496|||Regression, Logistic|Logistic regression stratified by prior Trastuzumab failure, hormone receptors status and region of the investigational site.|The odds ratio for the comparison afatinib + vinorelbine vs. trastuzumab + vinorelbine below 1 favours AV.|Results of presented analyses are to be seen as exploratory (no confirmatory testing was performed)||1.496|0.707|0.8829
72621692|NCT04526158|144773630|SUPERIORITY||Mean Difference (Final Values)|-0.7|||<|0.001|TWO_SIDED|95.0|-0.9|-0.5|||Mixed Models Analysis|Linear mixed model adjusted for baseline Pain Self-Efficacy, and design factors|estimates were generated from multiple imputed data|||-0.5|-0.9|<0.001
72621693|NCT04526158|144773630|SUPERIORITY||Mean Difference (Final Values)|-0.8|||<|0.001|TWO_SIDED|95.0|-1.0|-0.6|||Mixed Models Analysis|Linear mixed model adjusted for baseline Pain Self-Efficacy, and design factors|estimates were generated from multiple imputed data|||-0.6|-1.0|<0.001
72621694|NCT04526158|144773631|SUPERIORITY||Mean Difference (Final Values)|-7.5|||||TWO_SIDED|95.0|-13.9|-1.2||Used confidence interval to determine significance.|Mixed Models Analysis|Logistic mixed model adjusted for baseline values of BPI interference, Pain Self-Efficacy, and design factors|estimates were generated from multiple imputed data|||-1.2|-13.9|
72621695|NCT04526158|144773631|SUPERIORITY||Mean Difference (Final Values)|12.0|||||TWO_SIDED|95.0|6.4|17.6||Used confidence interval to determine significance.|Mixed Models Analysis|Logistic mixed model adjusted for baseline values of BPI interference, Pain Self-Efficacy, and design factors|estimates were generated from multiple imputed data|||17.6|6.4|
72621696|NCT04526158|144773631|SUPERIORITY||Mean Difference (Final Values)|19.5|||||TWO_SIDED|95.0|13.6|25.4||Used confidence interval to determine significance.|Mixed Models Analysis|Logistic mixed model adjusted for baseline values of BPI interference, Pain Self-Efficacy, and design factors|estimates were generated from multiple imputed data|||25.4|13.6|
72621697|NCT03533491|144773632|EQUIVALENCE|A test of the null hypothesis that the proportion of participants from pretest to posttest change is equal to zero.|Proportion Difference|0.07|STANDARD_ERROR_OF_MEAN|0.044||0.044|TWO_SIDED||||||t-test, 2 sided||A paired t-test that evaluates whether significant pretest to posttest change in the proportion of users is different from zero.|||||.044
72621698|NCT03533491|144773633|EQUIVALENCE|A test of the null hypothesis that the proportion who use from pretest to posttest is equal to zero.|Proportion Difference|0.035|STANDARD_ERROR_OF_MEAN|0.056||0.532|TWO_SIDED||||||t-test, 2 sided|A paired t-test that evaluates whether the proportion who use from pretest to posttest change is different from zero.||||||.532
72466239|NCT03181282|144455591|SUPERIORITY||Slope|0.0529|STANDARD_ERROR_OF_MEAN|0.0194||0.0194|TWO_SIDED|95.0|0.0132|0.0925|||Mixed Models Analysis|Mixed model analysis with repeated measures.||This analysis is for the On Medication / On Stimulation condition. Age was controlled for in the analysis given the baseline difference in age between groups.||0.0925|0.0132|0.0194
72466240|NCT03181282|144455591|SUPERIORITY||Slope|0.0718|STANDARD_ERROR_OF_MEAN|0.0231||0.004625|TWO_SIDED|95.0|0.0242|0.1194|||Mixed Models Analysis|Mixed models analysis with repeated measures.||This analysis is for the Off Medication / Off Stimulation Condition. Age was controlled for in the analysis given the baseline difference in age between groups.||0.1194|0.0242|0.004625
72466241|NCT03181282|144455592|SUPERIORITY||Slope|10.5248|STANDARD_ERROR_OF_MEAN|4.8439||0.038389|TWO_SIDED|95.0|0.6038|20.4459|||Mixed Models Analysis|Mixed models analysis with repeated measures.||This analysis is for the On Medication / On Stimulation condition. Age was controlled for in the analysis given the baseline difference in age between groups.||20.4459|0.6038|0.038389
72466242|NCT03181282|144455592|SUPERIORITY||Slope|7.7233|STANDARD_ERROR_OF_MEAN|4.668||0.109873|TWO_SIDED|95.0|-1.8652|17.3117|||Mixed Models Analysis|Mixed models analysis with repeated measures.||This analysis is for the Off Medication / Off Stimulation condition. Age was controlled for in the analysis given the baseline difference in age between groups.||17.3117|-1.8652|0.109873
72466243|NCT02484547|144455612|SUPERIORITY||Difference|-0.26||||0.0901|TWO_SIDED|95.0|-0.569|0.041|||MMRM|||Adjusted mean for each treatment group (Placebo, BIIB037 Low Dose, BIIB037 High Dose), difference with Placebo, 95% confidence interval and p-value at each time point were based on an MMRM model, with change from baseline in CDR-SB as dependent variable and with fixed effects of treatment group, categorical visit, treatment-by-visit interaction, baseline CDR-SB, baseline CDR-SB by visit interaction, baseline MMSE, AD symptomatic medication use at baseline, region, and laboratory ApoE status.||0.041|-0.569|0.0901
72466244|NCT02484547|144455612|SUPERIORITY||Difference|-0.39||||0.012|TWO_SIDED|95.0|-0.694|-0.086|||MMRM|||Adjusted mean for each treatment group (Placebo, BIIB037 Low Dose, BIIB037 High Dose), difference with Placebo, 95% confidence interval and p-value at each time point were based on an MMRM model, with change from baseline in CDR-SB as dependent variable and with fixed effects of treatment group, categorical visit, treatment-by-visit interaction, baseline CDR-SB, baseline CDR-SB by visit.||-0.086|-0.694|0.0120
72466245|NCT02484547|144455613|SUPERIORITY||Difference|-0.1||||0.7578|TWO_SIDED|95.0|-0.65|0.48|||MMRM|||Adjusted mean for each treatment group (Placebo, BIIB037 Low Dose, BIIB037 High Dose), difference from Placebo, 95% confidence interval and p-value at each time point were based on an MMRM model, with change from baseline in MMSE as dependent variable and with fixed effects of treatment group, categorical visit, treatment-by-visit interaction, baseline MMSE, baseline MMSE by visit interaction, AD symptomatic medication use at baseline, region, and laboratory ApoE status.||0.48|-0.65|0.7578
72466246|NCT02484547|144455613|SUPERIORITY||Difference|0.6||||0.0493|TWO_SIDED|95.0|0.0|1.13|||MMRM|||Adjusted mean for each treatment group (Placebo, BIIB037 Low Dose, BIIB037 High Dose), difference from Placebo, 95% confidence interval and p-value at each time point were based on an MMRM model, with change from baseline in MMSE as dependent variable and with fixed effects of treatment group, categorical visit, treatment-by-visit interaction, baseline MMSE, baseline MMSE by visit interaction, AD symptomatic medication use at baseline, region, and laboratory ApoE status.||1.13|0.00|0.0493
72466247|NCT02484547|144455614|SUPERIORITY||Difference|-0.701||||0.1962|TWO_SIDED|95.0|-1.7649|0.3627|||MMRM|||Adjusted mean for each treatment group(Placebo,BIIB037 Low Dose,BIIB037 High Dose),difference from Placebo, 95% confidence interval and p-value at each time point were based on an MMRM model, with change from baseline in ADASCog 13 as dependent variable and with fixed effects of treatment group,categorical visit,treatment-by-visit interaction,baseline ADAS-Cog 13,baseline ADAS-Cog 13 by visit interaction,baseline MMSE,AD symptomatic medication use at baseline,region, and laboratory ApoE status.||0.3627|-1.7649|0.1962
72503378|NCT01494038|144537489|SUPERIORITY||Incidence rate difference|-0.82|||||TWO_SIDED|95.0|-4.63|3.0||||||||3|-4.63|
72503379|NCT01494038|144537490|SUPERIORITY||Incidence rate difference|3.39|||||TWO_SIDED|95.0|-1.46|8.25||||||||8.25|-1.46|
72503380|NCT01494038|144537491|SUPERIORITY||Incidence rate difference|-0.82|||||TWO_SIDED|95.0|-4.63|3.0||||||||3|-4.63|
72503381|NCT01494038|144537492|SUPERIORITY||Incidence rate difference|3.38|||||TWO_SIDED|95.0|-1.31|8.07||||||||8.07|-1.31|
72503382|NCT01494038|144537493|SUPERIORITY||Incidence rate difference|-0.82|||||TWO_SIDED|95.0|-4.63|3.0||||||||3|-4.63|
72503383|NCT01494038|144537494|SUPERIORITY||Incidence rate difference|3.39|||||TWO_SIDED|95.0|-1.46|8.25||||||||8.25|-1.46|
72503384|NCT01494038|144537499|OTHER|Measuring agreement between the tests|||||<|0.0001|||||||Chi-squared|McNemars test||||||< 0.0001
72503385|NCT01494038|144537499|OTHER|Agreement between tests|Kappa coefficient|0.42|||||TWO_SIDED|95.0|0.35|0.5||||||||0.50|0.35|
72503386|NCT01494038|144537500|OTHER|Agreement between tests||||||0.22|||||||Chi-squared|McNemar's test||||||0.22
72503387|NCT01494038|144537500|OTHER|Agreement between tests|Kappa coefficient|0.11|||||TWO_SIDED|95.0|0.001|0.21||||||||0.21|0.001|
72503388|NCT01494038|144537501|OTHER|Agreement between tests|||||<|0.0001|||||||Chi-squared|McNemar's test||||||< 0.0001
72394527|NCT02310568|144295790|SUPERIORITY_OR_OTHER||LS Mean Difference|0.6|STANDARD_ERROR_OF_MEAN|1.94||0.736|TWO_SIDED|90.0|-2.6|3.8|||ANCOVA|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Total Score (Week 4): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.||3.8|-2.6|0.736
72394528|NCT02310568|144295790|SUPERIORITY_OR_OTHER||LS Mean Difference|1.1|STANDARD_ERROR_OF_MEAN|3.85||0.775|TWO_SIDED|90.0|-5.6|7.8|||ANCOVA|||(PF-06372865 7.5 mg - Placebo). Total Score (Week 8): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.||7.8|-5.6|0.775
72394529|NCT02310568|144295790|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.4|STANDARD_ERROR_OF_MEAN|4.0||0.553|TWO_SIDED|90.0|-9.4|4.5|||ANCOVA|||(PF-06372865 2.5 mg - Placebo). Total Score (Week 8): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.||4.5|-9.4|0.553
72394530|NCT02310568|144295790|SUPERIORITY_OR_OTHER||LS Mean Difference|3.5|STANDARD_ERROR_OF_MEAN|3.3||0.299|TWO_SIDED|90.0|-2.2|9.3|||ANCOVA|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Total Score ( Week 8): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.||9.3|-2.2|0.299
72466248|NCT02484547|144455614|SUPERIORITY||Difference|-1.4||||0.0097|TWO_SIDED|95.0|-2.4596|-0.3396|||MMRM|||Adjusted mean for each treatment group(Placebo,BIIB037 Low Dose,BIIB037 High Dose),difference from Placebo, 95% confidence interval and p-value at each time point were based on an MMRM model, with change from baseline in ADASCog 13 as dependent variable and with fixed effects of treatment group,categorical visit,treatment-by-visit interaction,baseline ADAS-Cog 13,baseline ADAS-Cog 13 by visit interaction,baseline MMSE,AD symptomatic medication use at baseline,region, and laboratory ApoE status.||-0.3396|-2.4596|0.0097
72466249|NCT02484547|144455615|SUPERIORITY||Difference|0.7||||0.1515|TWO_SIDED|95.0|-0.27|1.73|||MMRM|||Adjusted mean for each treatment group (Placebo, BIIB037 Low dose and BIIB037 High Dose), difference from Placebo,95% CI and p-value at each time point were based on an MMRM model, with change from baseline in ADCSADL-MCI as dependent variable and with fixed effects of treatment group, categorical visit, treatment-by-visit interaction, baseline ADCS-ADL-MCI, baseline ADCS-ADL-MCI by visit interaction, baseline MMSE, AD symptomatic medication use at baseline, region, and laboratory ApoE status.||1.73|-0.27|0.1515
72466250|NCT02484547|144455615|SUPERIORITY||Difference|1.7||||0.0006|TWO_SIDED|95.0|0.75|2.74|||MMRM|||Adjusted mean for each treatment group (Placebo, BIIB037 Low dose and BIIB037 High Dose), difference from Placebo,95% CI and p-value at each time point were based on an MMRM model, with change from baseline in ADCSADL-MCI as dependent variable and with fixed effects of treatment group, categorical visit, treatment-by-visit interaction, baseline ADCS-ADL-MCI, baseline ADCS-ADL-MCI by visit interaction, baseline MMSE, AD symptomatic medication use at baseline, region, and laboratory ApoE status.||2.74|0.75|0.0006
72466251|NCT00953199|144455664|SUPERIORITY_OR_OTHER|||||||0.45||||||.05 was set as level of significance|Chi-squared|||We calculated the sample size to be 570 in each arm, providing 80% power, allocation 1:1, two-sided, alpha 0.05, withdrawal rate of 3% and a reduction in pancreatitis from 8% to 4%. Randomization is performed with permuted blocks of 20. Analysis is based on intention to treat.||||.45
72466252|NCT03151551|144455688|SUPERIORITY||Rate Difference|8.1||||0.036|TWO_SIDED|95.0|0.5|15.8|||Regression, Logistic|||After data lock and initial analysis run, a medical inconsistency in baseline PASI data was identified (PASI=0 but BSA≥3%). The scenario was not anticipated or described in protocol or SAP. The inconsistency was resolved using medical judgment. The impacted participants had met baseline criteria for active psoriasis. Therefore, in the primary analysis, participants with baseline PASI=0 \& BSA≥3% were considered PASI100 responders if, and only if, PASI=0 \& BSA=0 achieved at week 24.||15.8|0.5|0.036
72466253|NCT03151551|144455689|NON_INFERIORITY|If the lower bound of the 2-sided 95% confidence Interval (CI) for the difference in proportions of responders on IXE minus ADA is greater than the pre-specified margin -12%, IXE will be deemed non-inferior to ADA.|Rate Difference|3.9|||||TWO_SIDED|95.0|-4.3|12.1||||||||12.1|-4.3|
72466254|NCT03151551|144455690|SUPERIORITY||Rate Difference|13.4||||0.001|TWO_SIDED|95.0|5.3|21.6|||Regression, Logistic|||After data lock and initial analysis run, a medical inconsistency in baseline PASI data was identified (PASI=0 but BSA≥3%). The scenario was not anticipated or described in protocol or SAP. The inconsistency was resolved using medical judgment. The impacted participants had met baseline criteria for active psoriasis. Therefore, in the primary analysis, participants with baseline PASI=0 \& BSA≥3% were considered PASI100 responders if, and only if, PASI=0 \& BSA=0 achieved at week 24.||21.6|5.3|0.001
72466255|NCT03151551|144455691|SUPERIORITY||Mean Difference (Final Values)|-1.03|STANDARD_ERROR_OF_MEAN|0.725||0.155|TWO_SIDED|95.0|-2.46|0.39|||Mixed Models Analysis|||||0.39|-2.46|0.155
72466256|NCT03151551|144455692|SUPERIORITY||Mean Difference (Final Values)|-0.06|STANDARD_ERROR_OF_MEAN|0.249||0.823|TWO_SIDED|95.0|-0.54|0.43|||Mixed Models Analysis|||||0.43|-0.54|0.823
72466257|NCT03151551|144455693|SUPERIORITY||Mean Difference (Final Values)|-0.67|STANDARD_ERROR_OF_MEAN|2.104||0.752|TWO_SIDED|95.0|-4.8|3.47|||Mixed Models Analysis|||||3.47|-4.80|0.752
72466258|NCT03151551|144455694|SUPERIORITY||Mean Difference (Final Values)|-2.79|STANDARD_ERROR_OF_MEAN|2.06||0.177|TWO_SIDED|95.0|-6.83|1.26|||Mixed Models Analysis|||||1.26|-6.83|0.177
72394531|NCT02310568|144295790|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.65||0.994|TWO_SIDED|90.0|-1.1|1.1|||ANCOVA|||(PF-06372865 7.5 mg - Placebo). Social Sub-Scale Score (Week 4): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.||1.1|-1.1|0.994
72466259|NCT03151551|144455695|SUPERIORITY||Mean Difference (Final Values)|-1.35|STANDARD_ERROR_OF_MEAN|1.391||0.332|TWO_SIDED|95.0|-4.08|1.38|||Mixed Models Analysis|||||1.38|-4.08|0.332
72466260|NCT03151551|144455696|SUPERIORITY||Mean Difference (Final Values)|0.32|STANDARD_ERROR_OF_MEAN|0.599||0.592|TWO_SIDED|95.0|-0.86|1.5|||Mixed Models Analysis|||||1.50|-0.86|0.592
72466261|NCT03151551|144455697|SUPERIORITY||Mean Difference (Final Values)|-0.06|STANDARD_ERROR_OF_MEAN|0.045||0.176|TWO_SIDED|95.0|-0.15|0.03|||Mixed Models Analysis|||||0.03|-0.15|0.176
72503389|NCT01494038|144537501|OTHER|Agreement between tests|Kappa coefficient|0.46|||||TWO_SIDED|95.0|0.39|0.53||||||||0.53|0.39|
72503390|NCT03815292|144537530|SUPERIORITY|||||||0.02|||||||Fisher Exact|||||||0.02
72466262|NCT03151551|144455698|SUPERIORITY||Rate Difference|13.1|||<|0.001|TWO_SIDED|95.0|5.4|20.7|||Regression, Logistic|||After data lock and initial analysis run, a medical inconsistency in baseline PASI data was identified (PASI=0 but BSA≥3%). The scenario was not anticipated or described in protocol or SAP. The inconsistency was resolved using medical judgment. The impacted participants had met baseline criteria for active psoriasis. Therefore, in the primary analysis, participants with baseline PASI=0 \& BSA≥3% were considered PASI100 responders if, and only if, PASI=0 \& BSA=0 achieved at week 52.||20.7|5.4|<0.001
72503391|NCT03815292|144537531|SUPERIORITY|||||||0.0445|||||||Wilcoxon (Mann-Whitney)|||This analysis applies to ∆ between baseline and after 24 weeks total scores row.||||0.0445
72466263|NCT03151551|144455699|SUPERIORITY||Mean Difference (Final Values)|-0.08|STANDARD_ERROR_OF_MEAN|0.091||0.368|TWO_SIDED|95.0|-0.26|0.1|||Mixed Models Analysis|||||0.10|-0.26|0.368
72466264|NCT03151551|144455700|SUPERIORITY||Rate Difference|6.4||||0.108|TWO_SIDED|95.0|-1.8|14.5|||Regression, Logistic|||MDA-18 Entheseal Points||14.5|-1.8|0.108
72466265|NCT03151551|144455700|SUPERIORITY||Rate Difference|5.3||||0.179|TWO_SIDED|95.0|-2.9|13.5|||Regression, Logistic|||MDA-6 Entheseal Points||13.5|-2.9|0.179
72466266|NCT03151551|144455701|SUPERIORITY||Rate Difference|-1.1||||0.846|TWO_SIDED|95.0|-8.9|6.7|||Regression, Logistic|||||6.7|-8.9|0.846
72466267|NCT03151551|144455702|SUPERIORITY||Mean Difference (Final Values)|-0.49|STANDARD_ERROR_OF_MEAN|0.17||0.004|TWO_SIDED|95.0|-0.83|-0.16|||Mixed Models Analysis|||||-0.16|-0.83|0.004
72466268|NCT03151551|144455703|SUPERIORITY||Mean Difference (Final Values)|0.12|STANDARD_ERROR_OF_MEAN|0.305||0.687|TWO_SIDED|95.0|-0.48|0.72|||Mixed Models Analysis|||||0.72|-0.48|0.687
72466269|NCT03151551|144455704|SUPERIORITY||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.144||0.507|TWO_SIDED|95.0|-0.19|0.38|||Mixed Models Analysis|||||0.38|-0.19|0.507
72466270|NCT03151551|144455705|SUPERIORITY||Mean Difference (Final Values)|-3.4|STANDARD_ERROR_OF_MEAN|14.951||0.82|TWO_SIDED|95.0|-32.78|25.99|||Mixed Models Analysis|||||25.99|-32.78|0.820
72466271|NCT03151551|144455706|SUPERIORITY||Mean Difference (Final Values)|-1.54|STANDARD_ERROR_OF_MEAN|0.79||0.052|TWO_SIDED|95.0|-3.09|0.02|||Mixed Models Analysis|||||0.02|-3.09|0.052
72466272|NCT03151551|144455707|SUPERIORITY||Mean Difference (Final Values)|-2.7|STANDARD_ERROR_OF_MEAN|0.949||0.005|TWO_SIDED|95.0|-4.57|-0.84|||Mixed Models Analysis|||||-0.84|-4.57|0.005
72466273|NCT03151551|144455708|SUPERIORITY||Mean Difference (Final Values)|-0.29|STANDARD_ERROR_OF_MEAN|0.202||0.158|TWO_SIDED|95.0|-0.68|0.11|||Mixed Models Analysis|||||0.11|-0.68|0.158
72466274|NCT03151551|144455709|SUPERIORITY||Mean Difference (Final Values)|-0.08|STANDARD_ERROR_OF_MEAN|0.21||0.711|TWO_SIDED|95.0|-0.49|0.33|||Mixed Models Analysis|||||0.33|-0.49|0.711
72466275|NCT03151551|144455710|SUPERIORITY||Mean Difference (Final Values)|0.52|STANDARD_ERROR_OF_MEAN|0.674||0.439|TWO_SIDED|95.0|-0.8|1.85|||Mixed Models Analysis|||||1.85|-0.80|0.439
72466276|NCT03151551|144455711|SUPERIORITY||Mean Difference (Final Values)|0.46|STANDARD_ERROR_OF_MEAN|0.86||0.594|TWO_SIDED|95.0|-1.23|2.15|||Mixed Models Analysis|||||2.15|-1.23|0.594
72466277|NCT03151551|144455712|SUPERIORITY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.017||0.979|TWO_SIDED|95.0|-0.03|0.03|||Mixed Models Analysis|||||0.03|-0.03|0.979
72503392|NCT03815292|144537532|SUPERIORITY|||||||0.0345|||||||Fisher Exact|||||||0.0345
72503393|NCT03815292|144537533|SUPERIORITY|||||||0.04|||||||Wilcoxon (Mann-Whitney)|||This analysis applies to ∆ between baseline and after 24 weeks total scores row.||||0.04
72503394|NCT03815292|144537534|SUPERIORITY|||||||0.0016|||||||t-test, 2 sided|||This analysis applies to ∆ between baseline and after 24 weeks total scores row.||||0.0016
72466278|NCT03151551|144455713|SUPERIORITY||Mean Difference (Final Values)|4.78|STANDARD_ERROR_OF_MEAN|1.782||0.008|TWO_SIDED|95.0|1.28|8.28|||Mixed Models Analysis|||||8.28|1.28|0.008
72466279|NCT03151551|144455714|SUPERIORITY||Mean Difference (Final Values)|-1.12|STANDARD_ERROR_OF_MEAN|0.335|<|0.001|TWO_SIDED|95.0|-1.78|-0.46|||Mixed Models Analysis|||||-0.46|-1.78|<0.001
72466280|NCT03151551|144455715|SUPERIORITY||Rate Difference|5.7||||0.165|TWO_SIDED|95.0|-2.4|13.7|||Regression, Logistic|||Effectiveness of Medication||13.7|-2.4|0.165
72466281|NCT03151551|144455715|SUPERIORITY||Rate Difference|6.7||||0.098|TWO_SIDED|95.0|-1.4|14.8|||Regression, Logistic|||Effectiveness over Time of Medication||14.8|-1.4|0.098
72466282|NCT03151551|144455715|SUPERIORITY||Rate Difference|4.6||||0.241|TWO_SIDED|95.0|-3.4|12.6|||Regression, Logistic|||Long Term Safety of Medication||12.6|-3.4|0.241
72466283|NCT03151551|144455715|SUPERIORITY||Rate Difference|4.9||||0.215|TWO_SIDED|95.0|-3.1|13.0|||Regression, Logistic|||Overall Satisfaction with Medication||13.0|-3.1|0.215
72466284|NCT03151551|144455715|SUPERIORITY||Rate Difference|2.1||||0.561|TWO_SIDED|95.0|-5.5|9.7|||Regression, Logistic|||Mostly Satisfied to any Questions||9.7|-5.5|0.561
72503395|NCT03815292|144537535|SUPERIORITY|||||||0.0054|||||||Wilcoxon (Mann-Whitney)|||This analysis applies to Therapeutic effect row.||||0.0054
72503396|NCT03815292|144537535|SUPERIORITY|||||||0.78|||||||Wilcoxon (Mann-Whitney)|||This analysis applies to Side effects row.||||0.78
72503397|NCT03815292|144537535|SUPERIORITY|||||||0.0042|||||||Wilcoxon (Mann-Whitney)|||This analysis applies to Efficiency index row.||||0.0042
72503398|NCT03815292|144537536|SUPERIORITY|||||||0.77|||||||Wilcoxon (Mann-Whitney)|||This analysis applies to ∆ between 24 and 28 weeks total scores row.||||0.77
72466285|NCT02979613|144455725|NON_INFERIORITY|Non-inferiority was assessed using a 95% confidence interval (CI) approach, with a non-inferiority margin of 4%.|Difference in the Percentages|0.0|||||TWO_SIDED|95.0|-1.9|2.0|||||Difference in the percentages of participants between treatment groups and its 95% CI were calculated based on the stratum-adjusted Mantel-Haenszel (MH) percentage, adjusted by baseline age groups (\< 50, ≥ 50 years) and baseline HBeAg status strata.|The null hypothesis was that the TAF group is at least 4% worse than the TDF group with respect to the percentage of participants with HBV DNA ≥ 20 IU/mL at Week 48. The alternative hypothesis was that the TAF group is less than 4% worse than the TDF group with respect to the percentage of participants with HBV DNA ≥ 20 IU/mL at Week 48.||2.0|-1.9|
72466286|NCT02979613|144455726|NON_INFERIORITY|Non-inferiority was assessed using a 95% confidence interval (CI) approach, with a non-inferiority margin of 4%.|Difference in the Percentages|0.0|||||TWO_SIDED|95.0|-1.9|1.9|||||Difference in the percentage of participants between treatment groups and its 95% CI were calculated based on the stratum-adjusted MH percentage, adjusted by baseline age groups (\< 50, ≥ 50 years) and baseline HBeAg status strata.|||1.9|-1.9|
72466287|NCT02979613|144455726|SUPERIORITY|||||||0.9953||||||P-value for the superiority tests compared the percentage of each HBV DNA outcome was from CMH tests stratified by baseline age groups and baseline HBeAg status strata.|Cochran-Mantel-Haenszel|||||||0.9953
72466288|NCT02979613|144455727|NON_INFERIORITY|Non-inferiority was assessed using a 95% CI approach, with a non-inferiority margin of 4%.|Difference in the Percentages|0.0|||||TWO_SIDED|95.0|-3.7|3.7|||||Difference in the percentage of participants between treatment groups and its 95% CI were calculated based on the stratum-adjusted MH percentage, adjusted by baseline age groups (\< 50, ≥ 50 years) and baseline HBeAg status strata.|||3.7|-3.7|
72466289|NCT02979613|144455727|SUPERIORITY|||||||0.98||||||P-value for the superiority tests compared the percentage of each HBV DNA outcome was from CMH tests stratified by baseline age groups and baseline HBeAg status strata.|Cochran-Mantel-Haenszel|||||||0.98
72503399|NCT03815292|144537537|SUPERIORITY|||||||0.0118|||||||Wilcoxon (Mann-Whitney)|||This analysis applies to ∆ between 24 and 28 weeks total scores row.||||0.0118
72503400|NCT03815292|144537538|SUPERIORITY|||||||0.058|||||||Wilcoxon (Mann-Whitney)|||This analysis applies to ∆ between 24 and 28 weeks total scores row.||||0.058
72503401|NCT00430781|144537540|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.05||||0.535||90.0|0.65|1.7||Stratified log-rank test with one-sided p-value. p\<=0.0037 required for significance, and p\>0.4956 indicated futility.|Log Rank||The estimated value is the hazard ratio comparing combination to lapatinib monotherapy|||1.7|0.65|0.535
72503402|NCT00430781|144537543|SUPERIORITY_OR_OTHER|||||||0.237||95.0||||One-sided p-value.|Fisher Exact|||||||0.237
72503403|NCT00430781|144537547|SUPERIORITY_OR_OTHER||Hazard Ratio, log|0.66||||0.013||90.0|0.48|0.91||Stratified log-rank test with one-sided p-value.|Log Rank|||||0.91|0.48|0.013
72503404|NCT04243369|144537551|OTHER|Only descriptive statistics was provided. The rate and the exact 95% CI of the rate using the Clopper-Pearson Exact method is calculated.|Rate|100.0|||||TWO_SIDED|95.0|88.4|100.0||||||||100|88.4|
72503405|NCT01521845|144537587|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.001
72370701|NCT00488683|144251643|SUPERIORITY_OR_OTHER||R-square|0.24||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and rise in hSBA after booster vaccination age for the serogroup A||||
72503406|NCT01521845|144537588|SUPERIORITY_OR_OTHER|||||||0.03||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.03
72503407|NCT01521845|144537589|SUPERIORITY_OR_OTHER|||||||1||95.0|||||not comparable|||||||1
72503408|NCT01532453|144537594|SUPERIORITY_OR_OTHER|||||||0.0278|TWO_SIDED|||||Rank ANCOVA With treatment, center, gender, transplanted organ as factors and age of organ transplant as a covariable.|ANCOVA|||||||0.0278
72503409|NCT01532453|144537595|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.579|||<|0.05|TWO_SIDED|95.0|0.2703|1.2405|||ANCOVA|||||1.2405|0.2703|<0.05
72370702|NCT00488683|144251643|SUPERIORITY_OR_OTHER||R-square|0.19||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between memory B cells one month after primary vaccination and rise in hSBA after booster vaccination age for the serogroup A||||
72370703|NCT00488683|144251643|SUPERIORITY_OR_OTHER||R-square|0.52||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and rise in hSBA after booster vaccination age for the serogroup C||||
72370704|NCT00488683|144251643|SUPERIORITY_OR_OTHER||R-square|0.07||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between memory B cells one month after primary vaccination and rise in hSBA after booster vaccination age for the serogroup C||||
72370705|NCT00488683|144251643|SUPERIORITY_OR_OTHER||R-square|1.0||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and rise in hSBA after booster vaccination age for the serogroup W-135||||
72370706|NCT00488683|144251643|SUPERIORITY_OR_OTHER||R-square|0.29||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between memory B cells one month after primary vaccination and rise in hSBA after booster vaccination age for the serogroup W-135||||
72370707|NCT00488683|144251643|SUPERIORITY_OR_OTHER||R-square|0.19||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and rise in hSBA after booster vaccination age for the serogroup Y||||
72370708|NCT00488683|144251643|SUPERIORITY_OR_OTHER||R-square|0.05||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between memory B cells one month after primary vaccination and rise in hSBA after booster vaccination age for the serogroup Y||||
72370709|NCT00488683|144251643|SUPERIORITY_OR_OTHER||R-square|0.7||||||95.0|||||Regression, Linear|||Linear regression coefficient between demographic factors, memory B cells one month after primary vaccination and rise in hSBA after booster vaccination age for the serogroup A||||
72370710|NCT00488683|144251643|SUPERIORITY_OR_OTHER||R-square|0.21||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between demographic factors, memory B cells one month after primary vaccination and rise in hSBA after booster vaccination age for the serogroup A||||
72370711|NCT00488683|144251643|SUPERIORITY_OR_OTHER||R-square|0.5||||||95.0|||||Regression, Linear|||Linear regression coefficient between demographic factors, memory B cells one month after primary vaccination and rise in hSBA after booster vaccination age for the serogroup C||||
72466290|NCT02979613|144455729|NON_INFERIORITY|Non-inferiority was assessed using a 95% confidence interval (CI) approach, with a non-inferiority margin of 4%.|Difference in the Percentages|0.9|||||TWO_SIDED|95.0|-3.5|5.2|||||Difference in the percentages of participants between treatment groups and its 95% CI were calculated based on the stratum-adjusted MH percentage, adjusted by baseline age groups (\< 50, ≥ 50 years) and baseline HBeAg status strata.|||5.2|-3.5|
72466291|NCT02979613|144455729|SUPERIORITY|||||||0.6863||||||P-value for the superiority tests compared the percentage of each HBV DNA outcome was from CMH tests stratified by baseline age groups and baseline HBeAg status strata.|Cochran-Mantel-Haenszel|||||||0.6863
72466292|NCT02979613|144455731|SUPERIORITY||Difference in the Percentages|1.4||||0.7258|TWO_SIDED|95.0|-7.2|10.1||P-value was from the CMH test, stratified by baseline age groups (\< 50, ≥ 50 years).|Cochran-Mantel-Haenszel||Difference in the percentage of participants between the treatment groups and its 95% CI were calculated based on the stratum-adjusted MH percentage, adjusted by baseline age groups.|||10.1|-7.2|0.7258
72466293|NCT02979613|144455732|SUPERIORITY||Difference in the Percentages|2.7||||0.1348|TWO_SIDED|95.0|-2.3|7.7||P-value was from the CMH test, stratified by baseline age groups (\< 50, ≥ 50 years).|Cochran-Mantel-Haenszel||Difference in the percentage of participants between the treatment groups and its 95% CI were calculated based on the stratum-adjusted MH percentage, adjusted by baseline age groups.|||7.7|-2.3|0.1348
72503410|NCT01458340|144537596|SUPERIORITY||LS Mean Difference|0.4|STANDARD_ERROR_OF_MEAN|1.69||0.6026|ONE_SIDED|95.0||3.2||α=0.05 significance level.|Mixed Model for Repeated Measures (MMRM)|One-sided p-values were obtained from the pairwise comparisons between TD-9855 group and placebo group based on the final model.||||3.2||0.6026
72503411|NCT01458340|144537596|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|1.69||0.4844|ONE_SIDED|95.0||2.7||α=0.05 significance level.|MMRM|One-sided p-values were obtained from the pairwise comparisons between TD-9855 group and placebo group based on the final model.||||2.7||0.4844
72503412|NCT01458340|144537597|SUPERIORITY||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|2.17||0.5269|ONE_SIDED|95.0||3.7||α=0.05 significance level.|MMRM|One-sided p-values were obtained from the pairwise comparisons between TD-9855 group and placebo group based on the final model.||||3.7||0.5269
72503413|NCT01458340|144537597|SUPERIORITY||LS Mean Difference|-1.7|STANDARD_ERROR_OF_MEAN|2.16||0.2092|ONE_SIDED|95.0||1.8||α=0.05 significance level.|MMRM|One-sided p-values were obtained from the pairwise comparisons between TD-9855 group and placebo group based on the final model.||||1.8||0.2092
72503414|NCT00091793|144537620|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.0|||<|0.0001||95.0|6.2|7.8|||ANCOVA|||||7.8|6.2|<0.0001
72503415|NCT01165229|144537634|OTHER|The efficacy of Herpes Zoster subunit (HZ/su) vaccine against herpes zoster disease was demonstrated if the lower limit (LL) of the two-sided 95% Confidence Interval (CI) of VE was above 10%.|Vaccine efficacy|90.02|||<|0.0001|TWO_SIDED|95.0|83.54|94.32|||Poisson exact test|||Comparison of vaccine efficacy in prevention of Herpes Zoster (HZ) disease between Zoster-022 GSK1437173A 70-79 YOA group and Zoster-022 Placebo 70-79 YOA group.||94.32|83.54|<0.0001
72564525|NCT01730040|144660694|SUPERIORITY_OR_OTHER||LS Mean Difference|-49.2|||<|0.0001|TWO_SIDED|99.0|-65.0|-33.5||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-33.5|-65|< 0.0001
72466294|NCT02979613|144455733|SUPERIORITY||Difference in the Percentages|9.0||||0.1005|TWO_SIDED|95.0|-2.0|20.1||P-value was from CMH tests stratified by baseline age groups (\< 50, ≥ 50 years).|Cochran-Mantel-Haenszel||Difference in the percentages of participants between treatment groups and its 95% CI were calculated based on the stratum-adjusted MH percentage, adjusted by baseline age groups.|||20.1|-2.0|0.1005
72466295|NCT02979613|144455734|SUPERIORITY||Difference in the Percentages|2.5||||0.4154|TWO_SIDED|95.0|-4.5|9.5||P-value was from CMH tests stratified by baseline age groups (\< 50, ≥ 50 years).|Cochran-Mantel-Haenszel||Difference in the percentages of participants between treatment groups and its 95% CI were calculated based on the stratum-adjusted MH percentage, adjusted by baseline age groups.|||9.5|-4.5|0.4154
72503416|NCT01165229|144537634|OTHER|The efficacy of HZ/su vaccine against herpes zoster disease was demonstrated if the lower limit of the of the 2-sided 95% CI of VE was above 10%|Vaccine efficacy|89.08|||<|0.0001|TWO_SIDED|95.0|74.65|96.16|||Poisson exact method|||Comparison of vaccine efficacy in prevention of Herpes Zoster (HZ) disease between Zoster-022 GSK1437173A \>=80YOA Group and Zoster-022 Placebo Zoster-022 Placebo \>=80YOA Group||96.16|74.65|<0.0001
72503417|NCT01165229|144537634|OTHER|The efficacy of HZ/su vaccine against herpes zoster disease was demonstrated if the lower limit of the of the 2-sided 95% CI of VE was above 10%|Vaccine efficacy|89.79|||<|0.0001|TWO_SIDED|95.0|84.29|93.66|||Poisson exact test|||Comparison of vaccine efficacy in prevention of Herpes Zoster (HZ) disease between Zoster-022 GSK1437173A \>=70YOA Group and Zoster-022 Placebo \>=70YOA Group||93.66|84.29|<0.0001
72503418|NCT01165229|144537635|OTHER|The efficacy of HZ/su vaccine against PHN was demonstrated if the lower limit of the of the 2-sided 95% CI of VE was above 0%|Vaccine efficacy|93.04|||<|0.0001|TWO_SIDED|95.0|72.47|99.19|||Poisson exact test|||Comparison of vaccine efficacy in prevention of Post-Herpetic Neuralgia (PHN) between Zoster-022/006 Pooled GSK1437173A 70-79YOA Group and Zoster-022/006 Pooled Placebo 70-79YOA Group||99.19|72.47|<0.0001
72503419|NCT01165229|144537635|OTHER|The efficacy of HZ/su vaccine against PHN was demonstrated if the lower limit of the of the 2-sided 95% CI of VE was above 0%|Vaccine efficacy|71.16||||0.1844|TWO_SIDED|95.0|-51.51|97.08|||Poisson exact test|||Comparison of vaccine efficacy in prevention of PHN between Zoster-022/006 Pooled GSK1437173A \>=80YOA Group and Zoster-022/006 Pooled Placebo \>=80YOA Group||97.08|-51.51|0.1844
72564526|NCT01730040|144660694|SUPERIORITY_OR_OTHER||LS Mean Difference|-32.6|||<|0.0001|TWO_SIDED|99.0|-48.4|-16.9||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-16.9|-48.4|< 0.0001
72564527|NCT01730040|144660694|SUPERIORITY_OR_OTHER||LS Mean Difference|-31.4|||<|0.0001|TWO_SIDED|99.0|-47.4|-15.4||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-15.4|-47.4|<0.0001
72564528|NCT01730040|144660695|SUPERIORITY_OR_OTHER||LS Mean Difference|-42.5|||<|0.0001|TWO_SIDED|99.0|-59.2|-25.7||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||A hierarchical testing procedure was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when previous endpoint was statistically significant at 1% level.||-25.7|-59.2|< 0.0001
72564529|NCT01730040|144660695|SUPERIORITY_OR_OTHER||LS Mean Difference|-24.9|||=|0.0002|TWO_SIDED|99.0|-41.9|-7.8||Threshold for significance≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-7.8|-41.9|= 0.0002
72564530|NCT01730040|144660695|SUPERIORITY_OR_OTHER||LS Mean Difference|-52.8|||<|0.0001|TWO_SIDED|99.0|-69.2|-36.5||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-36.5|-69.2|< 0.0001
72564531|NCT01730040|144660695|SUPERIORITY_OR_OTHER||LS Mean Difference|-35.0|||<|0.0001|TWO_SIDED|99.0|-51.3|-18.6|||Mixed Models Analysis|Threshold for significance ≤ 0.01.||Analysis description as per the statistical analysis 1 of this endpoint.||-18.6|-51.3|< 0.0001
72564532|NCT01730040|144660695|SUPERIORITY_OR_OTHER||LS Mean Difference|-33.4|||<|0.0001|TWO_SIDED|99.0|-50.0|-16.8||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-16.8|-50.0|< 0.0001
72564533|NCT01730040|144660696|SUPERIORITY_OR_OTHER||LS Mean Difference|-39.8|||<|0.0001|TWO_SIDED|99.0|-54.0|-25.6||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).||-25.6|-54|<0.0001
72564534|NCT01730040|144660696|SUPERIORITY_OR_OTHER||LS Mean Difference|-25.8|||<|0.0001|TWO_SIDED|99.0|-40.0|-11.6||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-11.6|-40.0|<0.0001
72564535|NCT01730040|144660696|SUPERIORITY_OR_OTHER||LS Mean Difference|-36.0|||<|0.0001|TWO_SIDED|99.0|-47.7|-24.3||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-24.3|-47.7|<0.0001
72466296|NCT02979613|144455735|SUPERIORITY||Difference in the Percentages|-2.0||||0.0281|TWO_SIDED|95.0|-4.4|0.3||P-value was from the CMH test, stratified by baseline age groups (\< 50, ≥ 50 years) and baseline HBeAg status strata.|Cochran-Mantel-Haenszel||Difference in the percentage of participants between the treatment groups and its 95% CI were calculated based on the stratum-adjusted MH percentage, adjusted by baseline age groups (\< 50, ≥ 50 years) and baseline HBeAg status strata.|||0.3|-4.4|0.0281
72466297|NCT02979613|144455737|SUPERIORITY||Difference in the Percentages|-0.8||||0.5373|TWO_SIDED|95.0|-3.7|2.1||P-value was from CMH tests stratified by baseline age groups (\< 50, ≥ 50 years) and baseline HBeAg status strata.|Cochran-Mantel-Haenszel||Difference in the percentages of participants between treatment groups and its 95% CI were calculated based on the stratum-adjusted MH percentage, adjusted by baseline age groups (\< 50, ≥ 50 years) and baseline HBeAg status strata.|||2.1|-3.7|0.5373
72466298|NCT02979613|144455738|SUPERIORITY||Difference in the Percentages|0.4||||0.5845|TWO_SIDED|95.0|-1.7|2.5||P-value was from CMH tests stratified by baseline age groups (\< 50, ≥ 50 years) and baseline HBeAg status strata.|Cochran-Mantel-Haenszel||Difference in the percentages of participants between treatment groups and its 95% CI were calculated based on the stratum-adjusted MH percentage, adjusted by baseline age groups (\< 50, ≥ 50 years) and baseline HBeAg status strata.|||2.5|-1.7|0.5845
72466299|NCT02979613|144455739|SUPERIORITY||Difference in the Percentages|4.5||||0.1405|TWO_SIDED|95.0|-1.6|10.6||P-value was from the CMH test, stratified by baseline age groups (\< 50, ≥ 50 years) and baseline HBeAg status strata.|Cochran-Mantel-Haenszel||Difference in the percentage of participants between the treatment groups and its 95% CI were calculated based on the stratum-adjusted MH percentage, adjusted by baseline age groups (\< 50, ≥ 50 years) and baseline HBeAg status strata.|Central Laboratory Criteria||10.6|-1.6|0.1405
72564536|NCT01730040|144660696|SUPERIORITY_OR_OTHER||LS Mean Difference|-27.3|||<|0.0001|TWO_SIDED|99.0|-39.2|-15.4||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-15.4|-39.2|<0.0001
72564537|NCT01730040|144660696|SUPERIORITY_OR_OTHER||LS Mean Difference|-20.9|||<|0.0001|TWO_SIDED|99.0|-32.8|-8.9||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-8.9|-32.8|<0.0001
72466300|NCT02979613|144455739|SUPERIORITY||Difference in the Percentages|3.8||||0.3133|TWO_SIDED|95.0|-3.7|11.4||P-value was from the CMH test, stratified by baseline age groups (\< 50, ≥ 50 years) and baseline HBeAg status strata.|Cochran-Mantel-Haenszel||Difference in the percentage of participants between the treatment groups and its 95% CI were calculated based on the stratum-adjusted MH percentage, adjusted by baseline age groups (\< 50, ≥ 50 years) and baseline HBeAg status strata.|AASLD Criteria||11.4|-3.7|0.3133
72466301|NCT02979613|144455740|SUPERIORITY||Difference in the Percentages|14.1||||0.3381|TWO_SIDED|95.0|-16.4|44.6||P-value was from the CMH test, stratified by baseline age groups (\< 50, ≥ 50 years) and baseline HBeAg status strata.|Cochran-Mantel-Haenszel||Difference in the percentage of participants between the treatment groups and its 95% CI were calculated based on the stratum-adjusted MH percentage, adjusted by baseline age groups (\< 50, ≥ 50 years) and baseline HBeAg status strata.|Central Laboratory criteria||44.6|-16.4|0.3381
72564538|NCT01730040|144660697|SUPERIORITY_OR_OTHER||LS Mean Difference|-44.5|||<|0.0001|TWO_SIDED|99.0|-55.8|-33.1||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).||-33.1|-55.8|<0.0001
72564539|NCT01730040|144660697|SUPERIORITY_OR_OTHER||LS Mean Difference|-26.6|||<|0.0001|TWO_SIDED|99.0|-38.0|-15.2||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-15.2|-38.0|<0.0001
72564540|NCT01730040|144660697|SUPERIORITY_OR_OTHER||LS Mean Difference|-36.3|||<|0.0001|TWO_SIDED|99.0|-48.1|-24.5||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-24.5|-48.1|<0.0001
72564541|NCT01730040|144660697|SUPERIORITY_OR_OTHER||LS Mean Difference|-27.7|||<|0.0001|TWO_SIDED|99.0|-39.6|-15.8||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-15.8|-39.6|<0.0001
72564542|NCT01730040|144660697|SUPERIORITY_OR_OTHER||LS Mean Difference|-20.2|||<|0.0001|TWO_SIDED|99.0|-32.2|-8.2||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-8.2|-32.2|<0.0001
72564543|NCT01730040|144660698|SUPERIORITY_OR_OTHER||LS Mean Difference|-29.3|||<|0.0001|TWO_SIDED|99.0|-42.0|-16.6||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).||-16.6|-42.0|<0.0001
72564544|NCT01730040|144660698|SUPERIORITY_OR_OTHER||LS Mean Difference|-23.6|||<|0.0001|TWO_SIDED|99.0|-36.6|-10.7||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-10.7|-36.6|<0.0001
72564545|NCT01730040|144660698|SUPERIORITY_OR_OTHER||LS Mean Difference|-38.4|||<|0.0001|TWO_SIDED|99.0|-50.8|-26.0||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-26.0|-50.8|<0.0001
72564546|NCT01730040|144660698|SUPERIORITY_OR_OTHER||LS Mean Difference|-30.9|||<|0.0001|TWO_SIDED|99.0|-43.2|-18.6||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-18.6|-43.2|<0.0001
72564547|NCT01730040|144660698|SUPERIORITY_OR_OTHER||LS Mean Difference|-27.6|||<|0.0001|TWO_SIDED|99.0|-40.1|-15.1||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-15.1|-40.1|<0.0001
72564548|NCT01730040|144660699|SUPERIORITY_OR_OTHER||LS Mean Difference|-32.6|||<|0.0001|TWO_SIDED|99.0|-44.6|-20.6||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).||-20.6|-44.6|<0.0001
72564549|NCT01730040|144660699|SUPERIORITY_OR_OTHER||LS Mean Difference|-25.1|||<|0.0001|TWO_SIDED|99.0|-37.3|-12.8||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-12.8|-37.3|<0.0001
72564550|NCT01730040|144660699|SUPERIORITY_OR_OTHER||LS Mean Difference|-38.3|||<|0.0001|TWO_SIDED|99.0|-51.2|-25.4||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-25.4|-51.2|<0.0001
72564551|NCT01730040|144660699|SUPERIORITY_OR_OTHER||LS Mean Difference|-29.8|||<|0.0001|TWO_SIDED|99.0|-42.6|-17.1||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-17.1|-42.6|<0.0001
72564552|NCT01730040|144660699|SUPERIORITY_OR_OTHER||LS Mean Difference|-26.4|||<|0.0001|TWO_SIDED|99.0|-39.4|-13.4||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-13.4|-39.4|<0.0001
72564553|NCT01730040|144660700|SUPERIORITY_OR_OTHER||LS Mean Difference|-30.4|||<|0.0001|TWO_SIDED|99.0|-44.7|-16.1||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).||-16.1|-44.7|<0.0001
72564554|NCT01730040|144660700|SUPERIORITY_OR_OTHER||LS Mean Difference|-21.6|||=|0.0002|TWO_SIDED|99.0|-36.1|-7.1||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-7.1|-36.1|=0.0002
72564555|NCT01730040|144660700|SUPERIORITY_OR_OTHER||LS Mean Difference|-41.1|||<|0.0001|TWO_SIDED|99.0|-54.7|-27.5||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-27.5|-54.7|<0.0001
72564556|NCT01730040|144660700|SUPERIORITY_OR_OTHER||LS Mean Difference|-30.2|||<|0.0001|TWO_SIDED|99.0|-43.7|-16.6||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-16.6|-43.7|<0.0001
72564557|NCT01730040|144660700|SUPERIORITY_OR_OTHER||LS Mean Difference|-26.6|||<|0.0001|TWO_SIDED|99.0|-40.3|-12.8||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-12.8|-40.3|<0.0001
72564558|NCT01730040|144660701|SUPERIORITY_OR_OTHER||LS Mean Difference|-33.0|||<|0.0001|TWO_SIDED|99.0|-47.0|-19.0||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).||-19.0|-47.0|<0.0001
72564559|NCT01730040|144660701|SUPERIORITY_OR_OTHER||LS Mean Difference|-22.4|||<|0.0001|TWO_SIDED|99.0|-36.6|-8.1||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-8.1|-36.6|<0.0001
72564560|NCT01730040|144660701|SUPERIORITY_OR_OTHER||LS Mean Difference|-43.6|||<|0.0001|TWO_SIDED|99.0|-57.4|-29.7||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-29.7|-57.4|<0.0001
72564561|NCT01730040|144660701|SUPERIORITY_OR_OTHER||LS Mean Difference|-32.1|||<|0.0001|TWO_SIDED|99.0|-46.0|-18.3||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-18.3|-46.0|<0.0001
72564562|NCT01730040|144660701|SUPERIORITY_OR_OTHER||LS Mean Difference|-27.3|||<|0.0001|TWO_SIDED|99.0|-41.4|-13.2||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-13.2|-41.4|<0.0001
72564563|NCT01730040|144660702|SUPERIORITY_OR_OTHER||LS Mean Difference|-23.1|||<|0.0001|TWO_SIDED|99.0|-32.9|-13.2||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).||-13.2|-32.9|<0.0001
72564564|NCT01730040|144660702|SUPERIORITY_OR_OTHER||LS Mean Difference|-15.8|||<|0.0001|TWO_SIDED|99.0|-25.8|-5.8||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-5.8|-25.8|<0.0001
72564565|NCT01730040|144660702|SUPERIORITY_OR_OTHER||LS Mean Difference|-28.9|||<|0.0001|TWO_SIDED|99.0|-39.4|-18.4||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-18.4|-39.4|<0.0001
72394532|NCT02310568|144295790|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.62||0.87|TWO_SIDED|90.0|-0.9|1.1|||ANCOVA|||(PF-06372865 2.5 mg - Placebo). Social Sub-Scale Score (Week 4): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.||1.1|-0.9|0.870
72564566|NCT01730040|144660702|SUPERIORITY_OR_OTHER||LS Mean Difference|-21.9|||<|0.0001|TWO_SIDED|99.0|-32.4|-11.4||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-11.4|-32.4|<0.0001
72394533|NCT02310568|144295790|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.74||0.885|TWO_SIDED|90.0|-1.3|1.1|||ANCOVA|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Social Sub-Scale Score (Week 4): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.||1.1|-1.3|0.885
72394534|NCT02310568|144295790|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|1.78||0.834|TWO_SIDED|90.0|-3.5|2.7|||ANCOVA|||(PF-06372865 7.5 mg - Placebo). Social Sub-Scale Score (Week 8): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.||2.7|-3.5|0.834
72394535|NCT02310568|144295790|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.0|STANDARD_ERROR_OF_MEAN|1.8||0.281|TWO_SIDED|90.0|-5.1|1.1|||ANCOVA|||(PF-06372865 2.5 mg - Placebo). Social Sub-Scale Score (Week 8): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.||1.1|-5.1|0.281
72394536|NCT02310568|144295790|SUPERIORITY_OR_OTHER||LS Mean Difference|1.6|STANDARD_ERROR_OF_MEAN|1.43||0.272|TWO_SIDED|90.0|-0.9|4.1|||ANCOVA|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Social Sub-Scale Score (Week 8): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.||4.1|-0.9|0.272
72394537|NCT02310568|144295790|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.73||0.249|TWO_SIDED|90.0|-2.1|0.4|||ANCOVA|||(PF-06372865 7.5 mg - Placebo). Work Sub-Scale Score (Week 4): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.||0.4|-2.1|0.249
72394538|NCT02310568|144295790|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.7|STANDARD_ERROR_OF_MEAN|0.7||0.016|TWO_SIDED|90.0|-2.9|-0.6|||ANCOVA|||(PF-06372865 2.5 mg - Placebo). Work Sub-Scale Score (Week 4): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.||-0.6|-2.9|0.016
72394539|NCT02310568|144295790|SUPERIORITY_OR_OTHER||LS Mean Difference|0.9|STANDARD_ERROR_OF_MEAN|0.82||0.285|TWO_SIDED|0.285|-0.5|2.3|||ANCOVA|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Work Sub-Scale Score (Week 4): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.||2.3|-0.5|0.285
72394540|NCT02310568|144295790|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|1.38||0.635|TWO_SIDED|90.0|-3.1|1.8|||ANCOVA|||(PF-06372865 7.5 mg - Placebo). Work Sub-Scale Score ( Week 8): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.||1.8|-3.1|0.635
72394541|NCT02310568|144295790|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.9|STANDARD_ERROR_OF_MEAN|1.43||0.217|TWO_SIDED|90.0|-4.4|0.7|||ANCOVA|||(PF-06372865 2.5 mg - Placebo). Work Sub-Scale Score (Week 8): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.||0.7|-4.4|0.217
72466302|NCT02979613|144455740|SUPERIORITY||Difference in the Percentages|23.8||||0.0136|TWO_SIDED|95.0|5.3|42.3||P-value was from the CMH test, stratified by baseline age groups (\< 50, ≥ 50 years) and baseline HBeAg status strata.|Cochran-Mantel-Haenszel||Difference in the percentage of participants between the treatment groups and its 95% CI were calculated based on the stratum-adjusted MH percentage, adjusted by baseline age groups (\< 50, ≥ 50 years) and baseline HBeAg status strata.|AASLD Criteria||42.3|5.3|0.0136
72564567|NCT01730040|144660702|SUPERIORITY_OR_OTHER||LS Mean Difference|-18.4|||<|0.0001|TWO_SIDED|99.0|-29.1|-7.7||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-7.7|-29.1|<0.0001
72466303|NCT02979613|144455741|SUPERIORITY||Difference in the Percentages|-2.9||||0.2803|TWO_SIDED|95.0|-8.4|2.6||P-value was from CMH tests stratified by baseline age groups (\< 50, ≥ 50 years) and baseline HBeAg status strata.|Cochran-Mantel-Haenszel||Difference in the percentages of participants between treatment groups and its 95% CI were calculated based on the stratum-adjusted MH percentage, adjusted by baseline age groups (\< 50, ≥ 50 years) and baseline HBeAg status strata.|Central Laboratory Criteria||2.6|-8.4|0.2803
72466304|NCT02979613|144455741|SUPERIORITY||Difference in the Percentages|-5.9||||0.0788|TWO_SIDED|95.0|-12.6|0.7||P-value was from CMH tests stratified by baseline age groups (\< 50, ≥ 50 years) and baseline HBeAg status strata.|Cochran-Mantel-Haenszel||Difference in the percentages of participants between treatment groups and its 95% CI were calculated based on the stratum-adjusted MH percentage, adjusted by baseline age groups (\< 50, ≥ 50 years) and baseline HBeAg status strata.|AASLD Criteria||0.7|-12.6|0.0788
72466305|NCT02979613|144455742|SUPERIORITY||Difference in the Percentages|-23.9||||0.088|TWO_SIDED|95.0|-51.2|3.4||P-value was from CMH tests stratified by baseline age groups (\< 50, ≥ 50 years) and baseline HBeAg status strata.|Cochran-Mantel-Haenszel||Difference in the percentages of participants between treatment groups and its 95% CI were calculated based on the stratum-adjusted MH percentage, adjusted by baseline age groups (\< 50, ≥ 50 years) and baseline HBeAg status strata.|Central Laboratory Criteria||3.4|-51.2|0.0880
72466306|NCT02979613|144455742|SUPERIORITY||Difference in the Percentages|-18.6||||0.051|TWO_SIDED|95.0|-37.4|0.2||P-value was from CMH tests stratified by baseline age groups (\< 50, ≥ 50 years) and baseline HBeAg status strata.|Cochran-Mantel-Haenszel||Difference in the percentages of participants between treatment groups and its 95% CI were calculated based on the stratum-adjusted MH percentage, adjusted by baseline age groups (\< 50, ≥ 50 years) and baseline HBeAg status strata.|AASLD Criteria||0.2|-37.4|0.0510
72466307|NCT02979613|144455743|SUPERIORITY||Difference in LSM|-0.02||||0.0186|TWO_SIDED|95.0|-0.03|0.0|||ANOVA|||P-value, difference in least squares mean (LSM), and its 95% CI were derived from analysis of variance (ANOVA) model with baseline age groups (\< 50, ≥ 50 years), baseline HBeAg status, and treatment group as fixed effects in the model.||0.00|-0.03|0.0186
72466308|NCT02979613|144455744|SUPERIORITY||Difference in LSM|0.0||||0.6956|TWO_SIDED|95.0|-0.02|0.01|||ANOVA|||P-value, difference in LSM, and its 95% CI were from ANOVA with baseline age groups (\<50, ≥ 50 years), baseline HBeAg status, and treatment group as fixed effects in the model.||0.01|-0.02|0.6956
72466309|NCT02979613|144455745|SUPERIORITY||Difference in LSM|1.167|||<|0.0001|TWO_SIDED|95.0|0.797|1.536|||ANOVA|||P-value, difference in LSM, and its 95% CI were from ANOVA with baseline age groups (\<50, ≥ 50 years), baseline HBeAg status, and treatment group as fixed effects in the model.||1.536|0.797|< 0.0001
72466310|NCT02979613|144455746|SUPERIORITY||Difference in LSM|0.977||||0.0002|TWO_SIDED|95.0|0.465|1.49|||ANOVA|||P-value, difference in LSM, and its 95% CI were from ANOVA with baseline age groups (\<50, ≥ 50 years), baseline HBeAg status, and treatment group as fixed effects in the model.||1.490|0.465|0.0002
72466311|NCT02979613|144455747|SUPERIORITY||Difference in LSM|1.881|||<|0.0001|TWO_SIDED|95.0|1.275|2.486|||ANOVA|||P-value, difference in LSM, and its 95% CI were from ANOVA with baseline age groups (\<50, ≥ 50 years), baseline HBeAg status, and treatment group as fixed effects in the model.||2.486|1.275|< 0.0001
72466312|NCT02979613|144455748|SUPERIORITY||Difference in LSM|0.604||||0.097|TWO_SIDED|95.0|-0.11|1.317|||ANOVA|||P-value, difference in LSM, and its 95% CI were from ANOVA with baseline age groups (\<50, ≥ 50 years), baseline HBeAg status, and treatment group as fixed effects in the model.||1.317|-0.110|0.0970
72466313|NCT02979613|144455749|SUPERIORITY||||||<|0.0001||||||P-values were from the 2-sided Wilcoxon rank sum test to compare the 2 treatment groups.|Wilcoxon rank sum test|||||||< 0.0001
72466314|NCT02979613|144455750|SUPERIORITY|||||||0.7535||||||P-values were from the 2-sided Wilcoxon rank sum test to compare the 2 treatment groups.|Wilcoxon rank sum test|||||||0.7535
72466315|NCT03282799|144455760|OTHER||||||<|0.001|||||||Fisher Exact|||||||<.001
72466316|NCT03282799|144455761|OTHER||||||<|0.001|||||||Fisher Exact|||||||<.001
72466317|NCT03282799|144455762|OTHER||||||<|0.001|||||||Fisher Exact|||||||<.001
72466318|NCT03282799|144455763|OTHER||||||>|0.99|||||||Fisher Exact|||||||>.99
72466319|NCT03282799|144455764|OTHER|||||||0.685|||||||Wilcoxon (Mann-Whitney)|||||||.685
72466320|NCT03282799|144455765|OTHER|||||||0.784|||||||Wilcoxon (Mann-Whitney)|||||||.784
72466321|NCT03282799|144455766|OTHER|||||||0.587|||||||Wilcoxon (Mann-Whitney)|||||||.587
72466322|NCT03282799|144455767|OTHER|||||||0.394|||||||Wilcoxon (Mann-Whitney)|||||||.394
72466323|NCT03282799|144455768|OTHER|||||||0.66|||||||Wilcoxon (Mann-Whitney)|||||||.660
72466324|NCT03282799|144455769|OTHER|||||||0.29|||||||Wilcoxon (Mann-Whitney)|||||||.290
72466325|NCT00143598|144455806|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.13||||0.58|TWO_SIDED|95.0|0.73|1.76|||Regression, Cox|Adjusted for centre||||1.76|.73|.58
72466326|NCT04260464|144455814|OTHER||Test/Reference Ratio|110.15|||||TWO_SIDED|95.0|83.76|144.86||||||Analysis of variance (ANOVA) was used to compare the natural log transformed Cmax for PF-06700841 between the normal renal function group (Reference) and the severe impaired renal function group (Test). Estimates of the adjusted mean differences (Test-Reference) and corresponding 90% confidence intervals (CIs) were obtained from the model.||144.86|83.76|
72466327|NCT04260464|144455814|OTHER||Test/Reference Ratio|94.58|||||TWO_SIDED|90.0|55.84|160.19||||||ANOVA was used to compare the natural log transformed Cmax for PF-06700841 between the normal renal function group (Reference) and the mild impaired renal function group (Test). Estimates of the adjusted mean differences (Test-Reference) and corresponding 90% confidence intervals (CIs) were obtained from the model.||160.19|55.84|
72466328|NCT04260464|144455814|OTHER||Test/Reference Ratio|124.2|||||TWO_SIDED|90.0|100.24|153.89||||||ANOVA was used to compare the natural log transformed Cmax for PF-06700841 between the normal renal function group (Reference) and the moderate impaired renal function group (Test). Estimates of the adjusted mean differences (Test-Reference) and corresponding 90% confidence intervals (CIs) were obtained from the model.||153.89|100.24|
72564568|NCT01730040|144660703|SUPERIORITY_OR_OTHER||LS Mean Difference|-31.5|||<|0.0001|TWO_SIDED|99.0|-41.6|-21.3||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).||-21.3|-41.6|<0.0001
72564569|NCT01730040|144660703|SUPERIORITY_OR_OTHER||LS Mean Difference|-25.3|||<|0.0001|TWO_SIDED|99.0|-35.4|-15.2||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-15.2|-35.4|<0.0001
72564570|NCT01730040|144660703|SUPERIORITY_OR_OTHER||LS Mean Difference|-26.7|||<|0.0001|TWO_SIDED|99.0|-35.9|-17.5||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-17.5|-35.9|<0.0001
72564571|NCT01730040|144660703|SUPERIORITY_OR_OTHER||LS Mean Difference|-22.2|||<|0.0001|TWO_SIDED|99.0|-31.5|-12.9||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-12.9|-31.5|<0.0001
72564572|NCT01730040|144660703|SUPERIORITY_OR_OTHER||LS Mean Difference|-15.9|||<|0.0001|TWO_SIDED|99.0|-25.2|-6.6||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-6.6|-25.2|<0.0001
72564573|NCT01730040|144660704|SUPERIORITY_OR_OTHER||LS Mean Difference|-33.5|||<|0.0001|TWO_SIDED|99.0|-45.3|-21.6||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).||-21.6|-45.3|<0.0001
72564574|NCT01730040|144660704|SUPERIORITY_OR_OTHER||LS Mean Difference|-23.4|||<|0.0001|TWO_SIDED|99.0|-35.2|-11.6||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-11.6|-35.2|<0.0001
72564575|NCT01730040|144660704|SUPERIORITY_OR_OTHER||LS Mean Difference|-29.3|||<|0.0001|TWO_SIDED|99.0|-39.0|-19.6||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-19.6|-39.0|<0.0001
72621699|NCT03533491|144773634|EQUIVALENCE|A test of the null hypothesis that the proportion of participants who use from pretest to posttest is equal to zero.|Proportion Difference|-0.053|STANDARD_ERROR_OF_MEAN|0.058||0.37|TWO_SIDED||||||t-test, 2 sided|A paired t-test that evaluates whether significant pretest to posttest change is different from zero.||||||.370
72621700|NCT03533491|144773635|EQUIVALENCE|A test of the null hypothesis that the proportion of participants that use from pretest to posttest is equal to zero.|Proportion Difference|0.14|STANDARD_ERROR_OF_MEAN|0.06||0.02|TWO_SIDED||||||t-test, 2 sided|A paired t-test that evaluates whether proportion who use from pretest to posttest is different from zero.||||||.020
72621701|NCT03533491|144773636|EQUIVALENCE|A test of the null hypothesis that the pretest to posttest change is equal to zero.|Mean Difference (Final Values)|0.031|STANDARD_ERROR_OF_MEAN|0.108||0.773|TWO_SIDED||||||t-test, 2 sided|A paired t-test that evaluates whether significant pretest to posttest change is different from zero.||||||.773
72621702|NCT03533491|144773637|EQUIVALENCE|A test of the null hypothesis that the pretest to posttest change is equal to zero.|Mean Difference (Final Values)|0.002|STANDARD_ERROR_OF_MEAN|0.08||0.978|TWO_SIDED||||||t-test, 2 sided|A paired t-test that evaluates whether significant pretest to posttest change is different from zero.||||||.978
72621703|NCT03533491|144773638|EQUIVALENCE|A test of the null hypothesis that the pretest to posttest change is equal to zero.|Mean Difference (Final Values)|0.029|STANDARD_ERROR_OF_MEAN|0.089||0.745|TWO_SIDED||||||t-test, 2 sided|A paired t-test that evaluates whether significant pretest to posttest change is different from zero.||||||.745
72564576|NCT01730040|144660704|SUPERIORITY_OR_OTHER||LS Mean Difference|-22.5|||<|0.0001|TWO_SIDED|99.0|-32.3|-12.7||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-12.7|-32.3|<0.0001
72564577|NCT01730040|144660704|SUPERIORITY_OR_OTHER||LS Mean Difference|-14.8|||<|0.0001|TWO_SIDED|99.0|-24.7|-4.9||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-4.9|-24.7|<0.0001
72564578|NCT01730040|144660705|SUPERIORITY_OR_OTHER||LS Mean Difference|-22.6|||<|0.0001|TWO_SIDED|99.0|-31.4|-13.8||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).||-13.8|-31.4|<0.0001
72564579|NCT01730040|144660705|SUPERIORITY_OR_OTHER||LS Mean Difference|-15.8|||<|0.0001|TWO_SIDED|99.0|-24.6|-7.0||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-7.0|-24.6|<0.0001
72564580|NCT01730040|144660705|SUPERIORITY_OR_OTHER||LS Mean Difference|-19.1|||<|0.0001|TWO_SIDED|99.0|-26.9|-11.4||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-11.4|-26.9|<0.0001
72564581|NCT01730040|144660705|SUPERIORITY_OR_OTHER||LS Mean Difference|-15.4|||<|0.0001|TWO_SIDED|99.0|-23.3|-7.6||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-7.6|-23.3|<0.0001
72564582|NCT01730040|144660705|SUPERIORITY_OR_OTHER||LS Mean Difference|-9.8|||=|0.0015|TWO_SIDED|99.0|-17.7|-1.9||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-1.9|-17.7|=0.0015
72564583|NCT01730040|144660706|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|16.7|||<|0.0001|TWO_SIDED|99.0|3.9|71.7||Threshold for significance ≤ 0.01.|Regression, Logistic|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant). Statistical analysis used a multiple imputation approach followed by a Logistic regression model.||71.7|3.9|<0.0001
72564584|NCT01730040|144660706|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.4|||=|0.0284|TWO_SIDED|99.0|0.8|14.6||Threshold for significance ≤ 0.01.|Regression, Logistic|||Analysis description as per the statistical analysis 1 of this endpoint.||14.6|0.8|=0.0284
72564585|NCT01730040|144660706|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|83.2|||<|0.0001|TWO_SIDED|99.0|11.6|596.8||Threshold for significance ≤ 0.01.|Regression, Logistic|||Analysis description as per the statistical analysis 1 of this endpoint.||596.8|11.6|<0.0001
72564586|NCT01730040|144660706|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|7.2|||=|0.0025|TWO_SIDED|99.0|1.3|38.3||Threshold for significance ≤ 0.01.|Regression, Logistic|||Analysis description as per the statistical analysis 1 of this endpoint.||38.3|1.3|=0.0025
72466329|NCT04260464|144455815|OTHER||Test/Reference Ratio|112.08|||||TWO_SIDED|95.0|60.85|206.45||||||ANOVA was used to compare the natural log transformed AUCinf for PF-06700841 between normal renal function group (Reference) and the severe impaired renal function group (Test). Estimates of the adjusted mean differences (Test-Reference) and corresponding 90% CIs were obtained from the model.||206.45|60.85|
72466330|NCT04260464|144455815|OTHER||Test/Reference Ratio|70.97|||||TWO_SIDED|90.0|27.6|182.49||||||ANOVA was used to compare the natural log transformed AUCinf for PF-06700841 between normal renal function group (Reference) and the mild impaired renal function group (Test). Estimates of the adjusted mean differences (Test-Reference) and corresponding 90% CIs were obtained from the model.||182.49|27.60|
72564587|NCT01730040|144660706|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|9.1|||=|0.0011|TWO_SIDED|99.0|1.6|52.2||Threshold for significance ≤ 0.01.|Regression, Logistic|||Analysis description as per the statistical analysis 1 of this endpoint.||52.2|1.6|=0.0011
72564588|NCT01730040|144660707|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|128.4|||<|0.0001|TWO_SIDED|99.0|14.2|1157.0||Threshold for significance ≤ 0.01.|Regression, Logistic|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant) for atorvastatin 40 mg baseline stratification). Statistical analysis used a multiple imputation approach followed by a Logistic regression model.||1157|14.2|<0.0001
72466331|NCT04260464|144455815|OTHER||Test/Reference Ratio|147.7|||||TWO_SIDED|90.0|75.17|290.21||||||ANOVA was used to compare the natural log transformed AUCinf for PF-06700841 between normal renal function group (Reference) and the moderate impaired renal function group (Test). Estimates of the adjusted mean differences (Test-Reference) and corresponding 90% CIs were obtained from the model.||290.21|75.17|
72466332|NCT04260464|144455816|OTHER||Test/Reference Ratio|177.53|||||TWO_SIDED|95.0|135.82|232.04||||||ANOVA was used to compare the natural log transformed Cmax for M1 between normal renal function group (Reference) and the severe impaired renal function group (Test). Estimates of the adjusted mean differences (Test-Reference) and corresponding 90% CIs were obtained from the model.||232.04|135.82|
72466333|NCT04260464|144455816|OTHER||Test/Reference Ratio|132.69|||||TWO_SIDED|90.0|95.08|185.17||||||ANOVA was used to compare the natural log transformed Cmax for M1 between normal renal function group (Reference) and the mild impaired renal function group (Test). Estimates of the adjusted mean differences (Test-Reference) and corresponding 90% CIs were obtained from the model.||185.17|95.08|
72466334|NCT04260464|144455816|OTHER||Test/Reference Ratio|122.04|||||TWO_SIDED|90.0|84.47|176.3||||||ANOVA was used to compare the natural log transformed Cmax for M1 between normal renal function group (Reference) and the moderate impaired renal function group (Test). Estimates of the adjusted mean differences (Test-Reference) and corresponding 90% CIs were obtained from the model.||176.30|84.47|
72466335|NCT04260464|144455817|OTHER||Test/Reference Ratio|445.99|||||TWO_SIDED|95.0|326.55|609.13||||||ANOVA was used to compare the natural log transformed AUCinf for M1 between normal renal function group (Reference) and the severe impaired renal function group (Test). Estimates of the adjusted mean differences (Test-Reference) and corresponding 90% CIs were obtained from the model.||609.13|326.55|
72466336|NCT04260464|144455817|OTHER||Test/Reference Ratio|144.63|||||TWO_SIDED|90.0|112.76|185.5||||||ANOVA was used to compare the natural log transformed AUCinf for M1 between normal renal function group (Reference) and the mild impaired renal function group (Test). Estimates of the adjusted mean differences (Test-Reference) and corresponding 90% CIs were obtained from the model.||185.50|112.76|
72466337|NCT04260464|144455817|OTHER||Test/Reference Ratio|229.12|||||TWO_SIDED|90.0|189.97|276.35||||||ANOVA was used to compare the natural log transformed AUCinf for M1 between normal renal function group (Reference) and the moderate impaired renal function group (Test). Estimates of the adjusted mean differences (Test-Reference) and corresponding 90% CIs were obtained from the model.||276.35|189.97|
72466338|NCT03469492|144455823|SUPERIORITY|||||||0.006|||||||Regression, Linear|||||||0.006
72564589|NCT01730040|144660707|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|10.9|||=|0.0015|TWO_SIDED|99.0|1.6|75.4||Threshold for significance ≤ 0.01.|Regression, Logistic|||Analysis description as per the statistical analysis 1 of this endpoint.||75.4|1.6|=0.0015
72503420|NCT01165229|144537635|OTHER|The efficacy of HZ/su vaccine against PHN was demonstrated if the lower limit of the of the 2-sided 95% CI of VE was above 0%|Vaccine efficacy|88.78|||<|0.0001|TWO_SIDED|95.0|68.7|97.1|||Poisson exact test|||Comparison of vaccine efficacy in prevention of PHN between Zoster-022/006 Pooled GSK1437173A \>=70YOA Group and Zoster-022/006 Pooled Placebo \>=70YOA Group||97.10|68.70|<0.0001
72503421|NCT01165229|144537636|OTHER|The efficacy of HZ/su vaccine against herpes zoster disease was demonstrated if the lower limit of the of the 2-sided 95% CI of VE was above 10%|Vaccine efficacy|91.27|||<|0.0001|TWO_SIDED|95.0|86.04|94.85|||Poisson exact test|||Comparison of vaccine efficacy in prevention of herpes zoster disease between Zoster-022/006 Pooled GSK1437173A 70-79YOA Group and Zoster-022/006 Pooled Placebo 70-79YOA Group||94.85|86.04|<0.0001
72564590|NCT01730040|144660707|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|13.7|||=|0.0008|TWO_SIDED|99.0|1.8|101.1||Threshold for significance ≤ 0.01.|Regression, Logistic|||Analysis description as per the statistical analysis 1 of this endpoint.||101.1|1.8|=0.0008
72621704|NCT03533491|144773639|EQUIVALENCE|A test of the null hypothesis that the pretest to posttest change is equal to zero.|Mean Difference (Final Values)|-0.154|STANDARD_ERROR_OF_MEAN|0.101||0.132|TWO_SIDED||||||t-test, 2 sided|A paired t-test that evaluates whether significant pretest to posttest change is different from zero.||||||.132
72466339|NCT03469492|144455827|SUPERIORITY|||||||0.266|||||||Mixed Models Analysis|||||||0.266
72466340|NCT03469492|144455830|SUPERIORITY|||||||0.2|||||||Mixed Models Analysis|||||||0.20
72466341|NCT03469492|144455831|SUPERIORITY|||||||0.25|||||||Mixed Models Analysis|||||||0.25
72466342|NCT01726049|144455833|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.4|||||TWO_SIDED|95.0|-4.5|-0.3||||||||-0.3|-4.5|
72466343|NCT01726049|144455833|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.7|||||TWO_SIDED|95.0|-7.1|-2.3||||||||-2.3|-7.1|
72466344|NCT01726049|144455834|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2|||||TWO_SIDED|95.0|-0.9|1.4||||||||1.4|-0.9|
72466345|NCT01726049|144455834|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.7|||||TWO_SIDED|95.0|-0.3|1.6||||||||1.6|-0.3|
72466346|NCT01726049|144455835|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|||||TWO_SIDED|95.0|-0.9|0.1||||||||0.1|-0.9|
72466347|NCT01726049|144455835|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|||||TWO_SIDED|95.0|-0.5|0.1||||||||0.1|-0.5|
72466348|NCT01726049|144455836|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5|||||TWO_SIDED|95.0|-1.9|1.0||||||||1.0|-1.9|
72394542|NCT02310568|144295790|SUPERIORITY_OR_OTHER||LS Mean Difference|1.2|STANDARD_ERROR_OF_MEAN|1.36||0.399|TWO_SIDED|90.0|-1.2|3.6|||ANCOVA|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Work Sub-Scale Score (Week 8): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.||3.6|-1.2|0.399
72394543|NCT02310568|144295790|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.62||0.429|TWO_SIDED|90.0|-1.5|0.5|||ANCOVA|||(PF-06372865 7.5 mg - Placebo). Family Sub-Scale Score (Week 4): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.||0.5|-1.5|0.429
72394544|NCT02310568|144295790|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.6||0.26|TWO_SIDED|90.0|-1.7|0.3|||ANCOVA|||(PF-06372865 2.5 mg - Placebo). Family Sub-Scale Score (Week 4): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.||0.3|-1.7|0.260
72394545|NCT02310568|144295790|SUPERIORITY_OR_OTHER||LS Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|0.7||0.799|TWO_SIDED|90.0|-1.0|1.3|||ANCOVA|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Family Sub-Scale Score (Week 4): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.||1.3|-1.0|0.799
72394546|NCT02310568|144295790|SUPERIORITY_OR_OTHER||LS Mean Difference|0.4|STANDARD_ERROR_OF_MEAN|1.22||0.738|TWO_SIDED|90.0|-1.7|2.5|||ANCOVA|||(PF-06372865 7.5 mg - Placebo). Family Sub-Scale Score (Week 8): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.||2.5|-1.7|0.738
72394547|NCT02310568|144295790|SUPERIORITY_OR_OTHER||LS Mean Difference|1.26|STANDARD_ERROR_OF_MEAN|-0.5||0.691|TWO_SIDED|90.0|-2.7|1.7|||ANCOVA|||(PF-06372865 2.5 mg - Placebo). Family Sub-Scale Score (Week 8): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.||1.7|-2.7|0.691
72394548|NCT02310568|144295790|SUPERIORITY_OR_OTHER||LS Mean Difference|0.9|STANDARD_ERROR_OF_MEAN|1.11||0.417|TWO_SIDED|90.0|-1.0|2.9|||ANCOVA|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Family Sub-Scale Score (Week 8): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.||2.9|-1.0|0.417
72394549|NCT02310568|144295790|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|2.11||0.998|TWO_SIDED|90.0|-3.7|3.7|||ANCOVA|||(PF-06372865 7.5 mg - Placebo). Total Score (Combined Stage 1 and Stage 2): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.||3.7|-3.7|0.998
72466349|NCT01726049|144455836|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.5|||||TWO_SIDED|95.0|-5.2|-1.8||||||||-1.8|-5.2|
72466350|NCT02806505|144455841|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.22||||0.6746|TWO_SIDED|95.0|0.49|3.06||Assessed by Cochran-Mantel-Haenszel test stratified by country (Brazil, France, Other) and HCV genotype (1 vs. non-1).|Cochran-Mantel-Haenszel|||The odds ratio is the ratio of the odds of a response in the Peginterferon alfa-2a 135 mcg group with the odds of a response in the Peginterferon alfa-2a 90 mcg group.||3.06|0.49|0.6746
72466351|NCT02806505|144455842|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.51||||0.3923|TWO_SIDED|95.0|0.6|3.76||Assessed by Cochran-Mantel-Haenszel test stratified by country (Brazil, France, Other) and HCV genotype (1 vs. non-1).|Cochran-Mantel-Haenszel|||The odds ratio is the ratio of the odds of a response in the Peginterferon alfa-2a 135 mcg group with the odds of a response in the Peginterferon alfa-2a 90 mcg group.||3.76|0.60|0.3923
72503422|NCT01165229|144537636|OTHER|The efficacy of HZ/su vaccine against herpes zoster disease was demonstrated if the lower limit of the of the 2-sided 95% CI of VE was above 10%|Vaccine efficacy|91.37|||<|0.0001|TWO_SIDED|95.0|80.22|96.94|||Poisson exact test|||Comparison of vaccine efficacy in prevention of herpes zoster disease between Zoster-022/006 Pooled GSK1437173A \>=80YOA Group and Zoster-022/006 Pooled Placebo \>=80YOA Group||96.94|80.22|<0.0001
72503423|NCT01165229|144537636|OTHER|The efficacy of HZ/su vaccine against herpes zoster disease was demonstrated if the lower limit of the of the 2-sided 95% CI of VE was above 10%|Vaccine efficacy|91.3|||<|0.0001|TWO_SIDED|95.0|86.88|94.46|||Poisson exact test|||Comparison of vaccine efficacy in prevention of herpes zoster disease between Zoster-022/006 pooled GSK1437173A \>=70 YOA Group and Zoster-022/006 Pooled Placebo \>=70YOA Group||94.46|86.88|<0.0001
72564591|NCT01730040|144660708|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|116.8|||<|0.0001|TWO_SIDED|99.0|14.7|927.5||Threshold for significance ≤ 0.01.|Regression, Logistic|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant) for atorvastatin 40 mg baseline stratification). Statistical analysis used a multiple imputation approach followed by a Logistic regression model.||927.5|14.7|<0.0001
72564592|NCT01730040|144660708|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|13.2|||<|0.0001|TWO_SIDED|99.0|2.5|68.8||Threshold for significance ≤ 0.01.|Regression, Logistic|||Analysis description as per the statistical analysis 1 of this endpoint.||68.8|2.5|<0.0001
72466352|NCT02806505|144455843|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.07||||0.8843|TWO_SIDED|95.0|0.43|2.68||Assessed by Cochran-Mantel-Haenszel test stratified by country (Brazil, France, Other) and HCV genotype (1 vs. non-1).|Cochran-Mantel-Haenszel|||Week 12: The odds ratio is the ratio of the odds of a response in the Peginterferon alfa-2a 135 mcg group with the odds of a response in the Peginterferon alfa-2a 90 mcg group.||2.68|0.43|0.8843
72466353|NCT02806505|144455843|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.75||||0.5866|TWO_SIDED|95.0|0.28|2.04||Assessed by Cochran-Mantel-Haenszel test stratified by country (Brazil, France, Other) and HCV genotype (1 vs. non-1).|Cochran-Mantel-Haenszel|||Week 24: The odds ratio is the ratio of the odds of a response in the Peginterferon alfa-2a 135 mcg group with the odds of a response in the Peginterferon alfa-2a 90 mcg group.||2.04|0.28|0.5866
72503424|NCT01165229|144537637|OTHER|The efficacy of HZ/su vaccine against PHN was demonstrated if the LL of the two-sided 95% CI of VE was above 0%.|Vaccine efficacy|90.8|||<|0.0001|TWO_SIDED|95.0|62.57|98.95|||Poisson exact test|||Comparison of of Vaccine Efficacy (VE) in prevention of PHN between Zoster-022 GSK1437173A 70-79YOA Group and Zoster-022 placebo 70-79YOA Group||98.95|62.57|<0.0001
72503425|NCT01165229|144537637|OTHER|The efficacy of HZ/su vaccine against PHN was demonstrated if the lower limit of the of the 2-sided 95% CI of VE was above 0%|Vaccine efficacy|65.76||||0.3072|TWO_SIDED|95.0|-91.58|96.62|||Poisson exact test|||Comparison of vaccine efficacy in prevention of PHN between Zoster-022 GSK1437173A \>=80YOA Group and Zoster-022 Placebo \>=80YOA Group||96.62|-91.58|0.3072
72564593|NCT01730040|144660708|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|9.9|||=|0.0004|TWO_SIDED|99.0|1.9|51.9||Threshold for significance ≤ 0.01.|Regression, Logistic|||Analysis description as per the statistical analysis 1 of this endpoint.||51.9|1.9|=0.0004
72466354|NCT02416713|144455846|SUPERIORITY||relative change from baseline|0.66||||0.12|TWO_SIDED|95.0|-0.18|1.51|||Mixed Models Analysis|||||1.51|-0.18|0.12
72466355|NCT02416713|144455846|SUPERIORITY||relative change from baseline|-0.3||||0.49|TWO_SIDED|95.0|-1.17|0.57|||Mixed Models Analysis|||||0.57|-1.17|0.49
72466356|NCT02416713|144455846|SUPERIORITY||Slope|-0.16||||0.7|TWO_SIDED|95.0|-1.0|0.69|||Mixed Models Analysis|||||0.69|-1.00|0.70
72503426|NCT01165229|144537637|OTHER|The efficacy of HZ/su vaccine against PHN was demonstrated if the lower limit of the of the 2-sided 95% CI of VE was above 0%|Vaccine efficacy|85.49|||<|0.0001|TWO_SIDED|95.0|58.52|96.3|||Poisson exact test|||Comparison of vaccine efficacy in prevention of PHN between Zoster-022 GSK1437173A \>=70YOA Group and Zoster-022 Placebo \>=70YOA Group||96.30|58.52|<0.0001
72466357|NCT03927690|144455972|SUPERIORITY||Difference (Test vs Reference)|-2.6||||0.887|TWO_SIDED|90.0|-6.2|1.0|||Mixed model repeated measures analysis||Comparison of model-based mean estimates.|Day 2||1.0|-6.2|0.887
72466358|NCT03927690|144455972|SUPERIORITY||Difference (Test vs Reference)|0.3||||0.431|TWO_SIDED|90.0|-2.6|3.2|||Mixed model repeated measures analysis||Comparison of model-based mean estimates.|Day 2||3.2|-2.6|0.431
72466359|NCT03927690|144455972|SUPERIORITY||Difference (Test vs Reference)|-1.0||||0.647|TWO_SIDED|90.0|-5.4|3.4|||Mixed model repeated measures analysis||Comparison of model-based mean estimates.|Day 8||3.4|-5.4|0.647
72466360|NCT03927690|144455972|SUPERIORITY||Difference (Test vs Reference)|2.4||||0.13|TWO_SIDED|90.0|-1.1|6.0|||Mixed model repeated measures analysis||Comparison of model-based mean estimates.|Day 8||6.0|-1.1|0.130
72466361|NCT03927690|144455972|SUPERIORITY||Difference (Test vs Reference)|-2.5||||0.818|TWO_SIDED|90.0|-6.9|2.0|||Mixed model repeated measures analysis||Comparison of model-based mean estimates|Day 15||2.0|-6.9|0.818
72466362|NCT03927690|144455972|SUPERIORITY||Difference (Test vs Reference)|0.3||||0.457|TWO_SIDED|90.0|-3.6|4.1|||Mixed model repeated measures analysis||Comparison of model-based mean estimates.|Day 15||4.1|-3.6|0.457
72466363|NCT03927690|144455972|SUPERIORITY||Difference (Test vs Reference)|-3.1||||0.906|TWO_SIDED|90.0|-6.9|0.8|||Mixed model repeated measures analysis||Comparison of model-based mean estimates.|Day 29||0.8|-6.9|0.906
72466364|NCT03927690|144455972|SUPERIORITY||Difference (Test vs Reference)|-0.4||||0.566|TWO_SIDED|90.0|-4.1|3.3|||Mixed model repeated measures analysis||Comparison of model-based mean estimates.|Day 29||3.3|-4.1|0.566
72466365|NCT03927690|144455972|SUPERIORITY||Difference (Test vs Reference)|-1.3||||0.686|TWO_SIDED|90.0|-5.6|3.1|||Mixed model repeated measures analysis||Comparison of model-based mean estimates.|Day 43||3.1|-5.6|0.686
72466366|NCT03927690|144455972|SUPERIORITY||Difference (Test vs Reference)|1.4||||0.28|TWO_SIDED|90.0|-2.5|5.2|||Mixed model repeated measures analysis||Comparison of model-based mean estimates.|Day 43||5.2|-2.5|0.280
72503427|NCT01165229|144537638|OTHER|The efficacy of HZ/su vaccine against duration of severe worst HZ associated pain was demonstrated if the LL of the two-sided 95% CI of VE derived from the Hazard ratio was above 0%.|Vaccine efficacy|21.7||||0.3749|TWO_SIDED|95.0|-34.4|54.39|||Poisson exact test|||Comparison of VE in reduction of duration of severe worst HZ associated pain between Zoster-022 GSK1437173A 70-79YOA Group and Zoster-022 Placebo 70-79YOA Group||54.39|-34.40|0.3749
72564594|NCT01730040|144660709|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|162.1|||<|0.0001|TWO_SIDED|99.0|17.3|1520.5||Threshold for significance ≤ 0.01.|Regression, Logistic|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant) for atorvastatin 40 mg baseline stratification). Statistical analysis used a multiple imputation approach followed by a Logistic regression model.||1520.5|17.3|<0.0001
72466367|NCT03927690|144455972|SUPERIORITY||Difference (Test vs Reference)|-2.4||||0.849|TWO_SIDED|90.0|-6.3|1.4|||Mixed model repeated measures analysis||Comparison of model-based mean estimates.|Day 57||1.4|-6.3|0.849
72466368|NCT03927690|144455972|SUPERIORITY||Difference (Test vs Reference)|1.5||||0.254|TWO_SIDED|90.0|-2.2|5.2|||Mixed model repeated measures analysis||Comparison of model-based mean estimates.|Day 57||5.2|-2.2|0.254
72466369|NCT03927690|144455972|SUPERIORITY||Difference (Test vs Reference)|-2.7||||0.866|TWO_SIDED|90.0|-6.6|1.3|||Mixed model repeated measures analysis||Comparison of model-based mean estimates.|Day 85||1.3|-6.6|0.866
72466370|NCT03927690|144455972|SUPERIORITY||Difference (Test vs Reference)|2.0||||0.198|TWO_SIDED|90.0|-1.9|5.8|||Mixed model repeated measures analysis||Comparison of model-based mean estimates.|Day 85||5.8|-1.9|0.198
72466371|NCT03927690|144455978|SUPERIORITY||Ratio (Test vs Reference)|1.2||||0.998|TWO_SIDED|90.0|1.08|1.33|||Mixed model repeated measures analysis||Comparison of model-based mean estimates.|Day 8||1.33|1.08|0.998
72466372|NCT03927690|144455978|SUPERIORITY||Ratio (Test vs Reference)|1.0||||0.527|TWO_SIDED|90.0|0.92|1.09|||Mixed model repeated measures analysis||Comparison of model-based mean estimates.|Day 8||1.09|0.92|0.527
72466373|NCT03927690|144455978|SUPERIORITY||Ratio (Test vs Reference)|1.21||||0.999|TWO_SIDED|90.0|1.1|1.33|||Mixed model repeated measures analysis||Comparison of model-based mean estimates|Day 15||1.33|1.10|0.999
72466374|NCT03927690|144455978|SUPERIORITY||Ratio (Test vs Reference)|1.03||||0.716|TWO_SIDED|90.0|0.95|1.12|||Mixed model repeated measures analysis||Comparison of model-based mean estimates.|Day 15||1.12|0.95|0.716
72466375|NCT03927690|144455978|SUPERIORITY||Ratio (Test vs Reference)|1.21||||1|TWO_SIDED|90.0|1.13|1.31|||Mixed model repeated measures analysis||Comparison of model-based mean estimates.|Day 29||1.31|1.13|1.000
72466376|NCT03927690|144455978|SUPERIORITY||Ratio (Test vs Reference)|0.98||||0.281|TWO_SIDED|90.0|0.91|1.05|||Mixed model repeated measures analysis||Comparison of model-based mean estimates.|Day 29||1.05|0.91|0.281
72466377|NCT03927690|144455978|SUPERIORITY||Ratio (Test vs Reference)|1.32||||1|TWO_SIDED|90.0|1.2|1.46|||Mixed model repeated measures analysis||Comparison of model-based mean estimates.|Day 43||1.46|1.20|1.000
72466378|NCT03927690|144455978|SUPERIORITY||Ratio (Test vs Reference)|0.96||||0.2|TWO_SIDED|90.0|0.88|1.04|||Mixed model repeated measures analysis||Comparison of model-based mean estimates.|Day 43||1.04|0.88|0.200
72466379|NCT03927690|144455978|SUPERIORITY||Ratio (Test vs Reference)|1.18||||1|TWO_SIDED|90.0|1.09|1.28|||Mixed model repeated measures analysis||Comparison of model-based mean estimates.|Day 57||1.28|1.09|1.000
72466380|NCT03927690|144455978|SUPERIORITY||Ratio (Test vs Reference)|0.94||||0.083|TWO_SIDED|90.0|0.87|1.01|||Mixed model repeated measures analysis||Comparison of model-based mean estimates.|Day 57||1.01|0.87|0.083
72466381|NCT03927690|144455978|SUPERIORITY||Ratio(Test vs Reference)|1.26||||1|TWO_SIDED|90.0|1.14|1.38|||Mixed model repeated measures analysis||Comparison of model-based mean estimates.|Day 85||1.38|1.14|1.000
72466382|NCT03927690|144455978|SUPERIORITY||Ratio(Test vs Reference)|0.96||||0.254|TWO_SIDED|90.0|0.88|1.06|||Mixed model repeated measures analysis||Comparison of model-based mean estimates.|Day 85||1.06|0.88|0.254
72466383|NCT00337285|144456005|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||||||< 0.0001
72503428|NCT01165229|144537638|OTHER|The efficacy of HZ/su vaccine against duration of severe worst HZ associated pain was demonstrated if the LL of the two-sided 95% CI of VE derived from the Hazard ratio was above 0%.|Vaccine efficacy|51.76||||0.2466|TWO_SIDED|95.0|-65.55|85.95|||Poisson exact test|||Comparison of VE in reduction of duration of severe worst HZ associated pain between Zoster-022 GSK1437173A \>=80YOA Group and Zoster-022 Placebo\>=80YOA Group||85.95|-65.55|0.2466
72466384|NCT00337285|144456007|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||||||< 0.0001
72466385|NCT01376050|144456015|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Fisher Exact|||||||>0.05
72466386|NCT01376050|144456016|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||t-test, 2 sided|||||||>0.05
72466387|NCT03463577|144456029|NON_INFERIORITY|The objective was to rule out a two-fold increase (non-inferiority testing) in the incidence rate of each of the maternal and infant adverse events, among vaccinated women with Boostrix and their infants as compared to the incidence in a matched cohort of unvaccinated women and their infants. The null hypothesis Ho: RR ≥ 2 was rejected if upper limit of the 98.75% CI for the adjusted RR was below 2.|Risk Ratio (RR)|1.38|||||TWO_SIDED|98.75|1.21|1.58|||||Adjusted relative risk with 98.75% CI was estimated by Poisson regression model|Demonstration of adjusted relative risk (RR) for pre-eclampsia and eclampsia in Exposed women cohort (on or after 1st day of 27th week of pregnancy) compared to Unexposed historical women cohort was less than 2 (non-inferiority testing).||1.58|1.21|
72466388|NCT03463577|144456029|NON_INFERIORITY|The objective was to rule out a two-fold increase (non-inferiority testing) in the incidence rate of each of the maternal and infant adverse events, among vaccinated women with Boostrix and their infants as compared to the incidence in a matched cohort of unvaccinated women and their infants. The null hypothesis Ho: RR ≥ 2 was rejected if upper limit of the 98.75% CI for the adjusted RR was below 2.|Risk Ratio (RR)|1.28|||||TWO_SIDED|98.75|1.12|1.47|||||Adjusted relative risk with 98.75% CI was estimated by Poisson regression model|Demonstration of adjusted RR for intra-uterine infections (chorioamnionitis and endometritis) in Exposed women cohort (on or after 1st day of 27th week of pregnancy) compared to Unexposed historical women cohort was less than 2 (non-inferiority testing).||1.47|1.12|
72466389|NCT03463577|144456030|NON_INFERIORITY|The objective was to rule out a two-fold increase (non-inferiority testing) in the incidence rate of each of the maternal and infant adverse events, among vaccinated women with Boostrix and their infants as compared to the incidence in a matched cohort of unvaccinated women and their infants. The null hypothesis Ho: RR ≥ 2 was rejected if upper limit of the 98.75% CI for the adjusted RR was below 2.|Risk Ratio (RR)|0.71|||||TWO_SIDED|98.75|0.64|0.78|||||Adjusted relative risk with 98.75% CI was estimated by Poisson regression model|Demonstration of adjusted RR for preterm delivery in Exposed women cohort (on or after 1st day of 27th week of pregnancy) compared to Unexposed historical women cohort was less than 2 (non-inferiority testing).||0.78|0.64|
72466390|NCT03463577|144456031|NON_INFERIORITY|The objective was to rule out a two-fold increase (non-inferiority testing) in the incidence rate of each of the maternal and infant adverse events, among vaccinated women with Boostrix and their infants as compared to the incidence in a matched cohort of unvaccinated women and their infants. The null hypothesis Ho: RR ≥ 2 was rejected if upper limit of the 98.75% CI for the adjusted RR was below 2.|Risk Ratio (RR)|1.04|||||TWO_SIDED|98.75|0.94|1.16|||||Adjusted RR with 98.75% CI-Poisson regression model|Demonstration of adjusted RR for small for gestational age in Exposed infants cohort (on or after 1st day of 27th week of pregnancy) compared to Unexposed historical infants cohort was less than 2 (non-inferiority testing).||1.16|0.94|
72466391|NCT03463577|144456032|SUPERIORITY|The objective was to explore differences (superiority testing) in the incidence rate of each of the maternal and infant adverse events, among vaccinated women with Boostrix and their infants as compared to the incidence in a matched cohort of unvaccinated women and their infants. Superiority to be concluded if lower limit of the 95% CI for the adjusted RR is above 1.|Risk Ratio (RR)|0.83|||||TWO_SIDED|95.0|0.7|0.98|||||Adjusted RR with 95% CI -Poisson regression model|Assessment of adjusted RR for poor fetal growth in the Exposed pregnant women cohort (on or after 1st day of 27th week of pregnancy) compared to the Unexposed historical women cohort was 1 or differed from 1 (superiority testing).||0.98|0.70|
72466392|NCT03463577|144456032|SUPERIORITY|The objective was to explore differences (superiority testing) in the incidence rate of each of the maternal and infant adverse events, among vaccinated women with Boostrix and their infants as compared to the incidence in a matched cohort of unvaccinated women and their infants. Superiority to be concluded if lower limit of the 95% CI for the adjusted RR is above 1.|Risk Ratio (RR)|1.31|||||TWO_SIDED|95.0|0.99|1.72|||||Adjusted RR with 95% CI - Poisson regression model|Assessment of adjusted RR for placental abortion in Exposed women cohort (on or after 1st day of 27th week of pregnancy) compared to Unexposed historical women cohort was 1 or differed from 1 (superiority testing).||1.72|0.99|
72466393|NCT03463577|144456032|SUPERIORITY|The objective was to explore differences (superiority testing) in the incidence rate of each of the maternal and infant adverse events, among vaccinated women with Boostrix and their infants as compared to the incidence in a matched cohort of unvaccinated women and their infants. Superiority to be concluded if lower limit of the 95% CI for the adjusted RR is above 1.|Risk Ratio (RR)|0.76|||||TWO_SIDED|95.0|0.64|0.91|||||Adjusted RR with 95% CI-Poisson regression model|Assessment of adjusted RR for preterm pre-labor rupture of membranes in Exposed women cohort (on or after 1st day of 27th week of pregnancy) compared to Unexposed historical women cohort was 1 or differed from 1 (superiority testing).||0.91|0.64|
72503429|NCT01165229|144537638|OTHER|The efficacy of HZ/su vaccine against duration of severe worst HZ associated pain was demonstrated if the LL of the two-sided 95% CI of VE derived from the Hazard ratio was above 0%.|Vaccine efficacy|28.4||||0.1877|TWO_SIDED|95.0|-17.69|56.44|||Poisson exact test|||Comparison of VE in reduction of duration of severe worst HZ associated pain between Zoster-022 GSK1437173A \>=70YOA Group and Zoster-022 Placebo\>=70YOA Group||56.44|-17.69|0.1877
72503430|NCT01165229|144537641|OTHER|Efficacy of the HZ/su vaccine against overall and HZ related hospitalizations was demonstrated if the LL of the two-sided 95% CI of VE was above 0%.|Vaccine efficacy|100.0||||0.2533|TWO_SIDED|95.0|-144.13|100.0|||Poisson exact test|||Comparison of VE in reduction of overall and HZ related hospitalizations between Zoster-022 GSK1437173A 70-79YOA Group and Zoster-022 Placebo 70-79YOA Group||100.00|-144.13|0.2533
72564595|NCT01730040|144660709|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|19.8|||<|0.0001|TWO_SIDED|99.0|3.1|126.3||Threshold for significance ≤ 0.01.|Regression, Logistic|||Analysis description as per the statistical analysis 1 of this endpoint.||126.3|3.1|<0.0001
72564596|NCT01730040|144660709|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|13.9|||=|0.0002|TWO_SIDED|99.0|2.2|88.1||Threshold for significance ≤ 0.01.|Regression, Logistic|||Analysis description as per the statistical analysis 1 of this endpoint.||88.1|2.2|=0.0002
72621705|NCT03533491|144773640|EQUIVALENCE|A test of the null hypothesis that the pretest to posttest change is equal to zero.|Mean Difference (Final Values)|0.066|STANDARD_ERROR_OF_MEAN|0.111||0.551|TWO_SIDED||||||t-test, 2 sided|A paired t-test that evaluates whether significant pretest to posttest change is different from zero.||||||.551
72466394|NCT03463577|144456033|SUPERIORITY|The objective was to explore differences (superiority testing) in the incidence rate of each of the maternal and infant adverse events, among vaccinated women with Boostrix and their infants as compared to the incidence in a matched cohort of unvaccinated women and their infants. The null hypothesis H0 RR =1 was rejected if lower limit of 95% CI for adjusted RR was above 1.|Risk Ratio (RR)|0.38|||||TWO_SIDED|95.0|0.22|0.67|||||Adjusted RR with 95% CI-Poisson regression model|Assessment of adjusted RR for stillbirth/fetal death in Exposed women cohort (on or after 1st day of 27th week of pregnancy) compared to Unexposed historical women cohort was 1 or differed from 1 (superiority testing).||0.67|0.22|
72466395|NCT03463577|144456033|SUPERIORITY|The objective was to explore differences (superiority testing) in the incidence rate of each of the maternal and infant adverse events, among vaccinated women with Boostrix and their infants as compared to the incidence in a matched cohort of unvaccinated women and their infants. The null hypothesis H0 RR=1 was rejected if lower limit of 95% CI for adjusted RR was above 1.|Risk Ratio (RR)|1.07|||||TWO_SIDED|95.0|0.86|1.33|||||Adjusted RR with 95% CI-Poisson regression model|Assessment of adjusted RR for transfusion during delivery hospitalization in Exposed women cohort (on or after 1st day of 27th week of pregnancy) compared to Unexposed historical women cohort was 1 or differed from 1 (superiority testing).||1.33|0.86|
72466396|NCT03463577|144456034|SUPERIORITY|The objective was to explore differences (superiority testing) in the incidence rate of each of the maternal and infant adverse events, among vaccinated women with Boostrix and their infants as compared to the incidence in a matched cohort of unvaccinated women and their infants. The null hypothesis H0 RR=1 was rejected if lower limit of 95% CI for adjusted RR was above 1.|Risk Ratio (RR)|0.81|||||TWO_SIDED|95.0|0.38|1.73|||||Adjusted RR with 95% CI-Poisson regression model|Assessment of adjusted RR for neonatal death in Exposed infants cohort (on or after 1st day of 27th week of pregnancy) compared to Unexposed historical infants cohort was 1 or differed from 1 (superiority testing).||1.73|0.38|
72466397|NCT03463577|144456034|SUPERIORITY|The objective was to explore differences (superiority testing) in the incidence rate of each of the maternal and infant adverse events, among vaccinated women with Boostrix and their infants as compared to the incidence in a matched cohort of unvaccinated women and their infants. The null hypothesis H0 RR=1 was rejected if lower limit of 95% CI for adjusted RR was above 1.|Risk Ratio (RR)|1.35|||||TWO_SIDED|95.0|0.81|2.24|||||Adjusted RR with 95% CI-Poisson regression model|Assessment of adjusted RR for congenital anomalies of nervous system in Exposed infants cohort (on or after 1st day of 27th week of pregnancy) compared to Unexposed historical infants cohort was 1 or differed from 1 (superiority testing).||2.24|0.81|
72466398|NCT03463577|144456034|SUPERIORITY|The objective was to explore differences (superiority testing) in the incidence rate of each of the maternal and infant adverse events, among vaccinated women with Boostrix and their infants as compared to the incidence in a matched cohort of unvaccinated women and their infants. The null hypothesis H0 RR=1 was rejected if lower limit of 95% CI for adjusted RR was above 1.|Risk Ratio (RR)|1.17|||||TWO_SIDED|95.0|1.06|1.29|||||Adjusted RR with 95% CI-Poisson regression model|Assessment of adjusted RR for congenital anomalies of eye in Exposed infants cohort (on or after 1st day of 27th week of pregnancy) compared to Unexposed historical infants cohort was 1 or differed from 1 (superiority testing).||1.29|1.06|
72466399|NCT03463577|144456034|SUPERIORITY|The objective was to explore differences (superiority testing) in the incidence rate of each of the maternal and infant adverse events, among vaccinated women with Boostrix and their infants as compared to the incidence in a matched cohort of unvaccinated women and their infants. The null hypothesis H0 RR=1 was rejected if lower limit of 95% CI for adjusted RR was above 1.|Risk Ratio (RR)|2.02|||||TWO_SIDED|95.0|1.59|2.55|||||Adjusted RR with 95% CI-Poisson regression model|Assessment of adjusted RR for congenital anomalies of ear, face or neck in Exposed infants cohort (on or after 1st day of 27th week of pregnancy) compared to Unexposed historical infants cohort was 1 or differed from 1 (superiority testing.||2.55|1.59|
72503431|NCT01165229|144537641|OTHER|Efficacy of the HZ/su vaccine against overall and HZ related hospitalizations was demonstrated if the LL of the two-sided 95% CI of VE was above 0%.|Vaccine efficacy|100.0||||0.5024|TWO_SIDED|95.0|-435.14|100.0|||Poisson exact test|||Comparison of VE in reduction of overall and HZ related hospitalizations between Zoster-022 GSK1437173A \>=80YOA Group and Zoster-022 Placebo \>=80YOA Group||100.00|-435.14|0.5024
72503432|NCT01165229|144537641|OTHER|Efficacy of the HZ/su vaccine against overall and HZ related hospitalizations was demonstrated if the LL of the two-sided 95% CI of VE was above 0%.|Vaccine efficacy|100.0||||0.0636|TWO_SIDED|95.0|-9.92|100.0|||Poisson exact test|||Comparison of VE in reduction of overall and HZ related hospitalizations between Zoster-022 GSK1437173A \>=70YOA Group and Zoster-022 Placebo \>=70YOA Group||100.00|-9.92|0.0636
72503433|NCT01165229|144537642|OTHER|Efficacy of the HZ/su vaccine against HZ related complications was demonstrated if the LL of the VE was above 0%.|Vaccine efficacy|-65.69||||0.4947|TWO_SIDED|95.0|-827.06|73.62|||Poisson exact test|||Comparison of VE in reduction of HZ related complications between Zoster-022 GSK1437173A 70-79YOA Group and Zoster-022 Placebo 70-79YOA Group||73.62|-827.06|0.4947
72564597|NCT01730040|144660710|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-21.1|||=|0.0004|TWO_SIDED|99.0|-36.3|-5.9||Threshold for significance ≤ 0.01.|Regression, Robust|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant) for atorvastatin 40 mg baseline stratification). Statistical analysis used a multiple imputation approach followed by a robust regression model.||-5.9|-36.3|=0.0004
72564598|NCT01730040|144660710|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-25.9|||<|0.0001|TWO_SIDED|99.0|-40.2|-11.6||Threshold for significance ≤ 0.01.|Regression, Robust|||Analysis description as per the statistical analysis 1 of this endpoint.||-11.6|-40.2|<0.0001
72564599|NCT01730040|144660710|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-31.0|||<|0.0001|TWO_SIDED|99.0|-45.6|-16.4||Threshold for significance ≤ 0.01.|Regression, Robust|||Analysis description as per the statistical analysis 1 of this endpoint.||-16.4|-45.6|<0.0001
72370712|NCT00488683|144251643|SUPERIORITY_OR_OTHER||R-square|0.16||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between demographic factors, memory B cells one month after primary vaccination and rise in hSBA after booster vaccination age for the serogroup C||||
72370713|NCT00488683|144251643|SUPERIORITY_OR_OTHER||R-square|1.0||||||95.0|||||Regression, Linear|||Linear regression coefficient between demographic factors, memory B cells one month after primary vaccination and rise in hSBA after booster vaccination age for the serogroup W-135||||
72466400|NCT03463577|144456034|SUPERIORITY|The objective was to explore differences (superiority testing) in the incidence rate of each of the maternal and infant adverse events, among vaccinated women with Boostrix and their infants as compared to the incidence in a matched cohort of unvaccinated women and their infants. The null hypothesis H0 RR=1 was rejected if lower limit of 95% CI for adjusted RR was above 1.|Risk Ratio (RR)|1.12|||||TWO_SIDED|95.0|0.96|1.31|||||Adjusted RR with 95% CI-Poisson regression model|Assessment of adjusted RR for congenital anomalies of cardiovascular system in Exposed infants cohort (on or after 1st day of 27th week of pregnancy) compared to Unexposed historical infant cohort was 1 or differed from 1 (superiority testing).||1.31|0.96|
72466401|NCT03463577|144456034|SUPERIORITY|The objective was to explore differences (superiority testing) in the incidence rate of each of the maternal and infant adverse events, among vaccinated women with Boostrix and their infants as compared to the incidence in a matched cohort of unvaccinated women and their infants. The null hypothesis H0 RR=1 was rejected if lower limit of 95% CI for adjusted RR was above 1.|Risk Ratio (RR)|1.34|||||TWO_SIDED|95.0|1.07|1.68|||||Adjusted RR with 95% CI-Poisson regression model|Assessment of adjusted RR for congenital anomalies of respiratory system in Exposed infants cohort (on or after 1st day of 27th week of pregnancy) compared to Unexposed historical infants cohort was1 or differed from 1 (superiority testing).||1.68|1.07|
72466402|NCT03463577|144456034|SUPERIORITY|The objective was to explore differences (superiority testing) in the incidence rate of each of the maternal and infant adverse events, among vaccinated women with Boostrix and their infants as compared to the incidence in a matched cohort of unvaccinated women and their infants. The null hypothesis H0 RR=1 was rejected if lower limit of 95% CI for adjusted RR was above 1.|Risk Ratio (RR)|1.41||||||95.0|0.78|2.57|||||Adjusted RR with 95% CI-Poisson regression model|Assessment of adjusted RR for clefts in Exposed infants cohort (on or after 1st day of 27th week of pregnancy) compared to Unexposed historical infants cohort was 1 or differed from 1 (superiority testing).||2.57|0.78|
72466403|NCT03463577|144456034|SUPERIORITY|The objective was to explore differences (superiority testing) in the incidence rate of each of the maternal and infant adverse events, among vaccinated women with Boostrix and their infants as compared to the incidence in a matched cohort of unvaccinated women and their infants. The null hypothesis H0 RR=1 was rejected if lower limit of 95% CI for adjusted RR was above 1.|Risk Ratio (RR)|1.75|||||TWO_SIDED|95.0|1.57|1.95|||||Adjusted RR with 95% CI-Poisson regression model|Assessment of adjusted RR for congenital anomalies of upper gastrointestinal system in Exposed infants cohort (on or after 1st day of 27th week of pregnancy) compared to Unexposed historical infants cohort was 1 or differed from 1 (superiority testing).||1.95|1.57|
72466404|NCT03463577|144456034|SUPERIORITY|The objective was to explore differences (superiority testing) in the incidence rate of each of the maternal and infant adverse events, among vaccinated women with Boostrix and their infants as compared to the incidence in a matched cohort of unvaccinated women and their infants. The null hypothesis H0 RR=1 was rejected if lower limit of 95% CI for adjusted RR was above 1.|Risk Ratio (RR)|0.63|||||TWO_SIDED|95.0|0.36|1.12|||||Adjusted RR with 95% CI-Poisson regression model|Assessment of adjusted RR for congenital anomalies of lower gastrointestinal system in Exposed infants cohort (on or after 1st day of 27th week of pregnancy) compared to Unexposed historical infants cohort was 1 or differed from 1 (superiority testing).||1.12|0.36|
72466405|NCT03463577|144456034|SUPERIORITY|The objective was to explore differences (superiority testing) in the incidence rate of each of the maternal and infant adverse events, among vaccinated women with Boostrix and their infants as compared to the incidence in a matched cohort of unvaccinated women and their infants. The null hypothesis H0 RR=1 was rejected if lower limit of 95% CI for adjusted RR was above 1.|Risk Ratio (RR)|1.19|||||TWO_SIDED|95.0|1.01|1.42|||||Adjusted RR with 95% CI-Poisson regression model|Assessment of adjusted RR for congenital anomalies of genital organs in Exposed infants cohort (on or after 1st day of 27th week of pregnancy) compared to Unexposed historical infants cohort was 1 or differed from 1 (superiority testing).||1.42|1.01|
72466406|NCT03463577|144456034|SUPERIORITY|The objective was to explore differences (superiority testing) in the incidence rate of each of the maternal and infant adverse events, among vaccinated women with Boostrix and their infants as compared to the incidence in a matched cohort of unvaccinated women and their infants. The null hypothesis H0 RR=1 was rejected if lower limit of 95% CI for adjusted RR was above 1.|Risk Ratio (RR)|1.4|||||TWO_SIDED|95.0|1.04|1.88|||||Adjusted RR with 95% CI-Poisson regression model|Assessment of adjusted RR for congenital anomalies of renal system in Exposed infants cohort (on or after 1st day of 27th week of pregnancy) compared to Unexposed historical infants cohort was 1 or differed from 1 (superiority testing.||1.88|1.04|
72503434|NCT01165229|144537642|OTHER|Efficacy of the HZ/su vaccine against HZ related complications was demonstrated if the LL of the VE was above 0%|Vaccine efficacy|100.0||||1|TWO_SIDED|95.0|-558.05|100.0|||Poisson exact test|||Comparison of VE in reduction of HZ related complications between Zoster-022 GSK1437173A \>=80YOA Group and Zoster-022 Placebo \>=80YOA Group||100.00|-558.05|1.0000
72503435|NCT01165229|144537642|OTHER|Efficacy of the HZ/su vaccine against HZ related complications was demonstrated if the LL of the VE was above 0%|Vaccine efficacy|0.97||||1|TWO_SIDED|95.0|-433.32|83.16|||Poisson exact test|||Comparison of VE in reduction of HZ related complications between Zoster-022 GSK1437173A \>=70YOA Group and Zoster-022 Placebo \>=70YOA Group||83.16|-433.32|1.0000
72503436|NCT01165229|144537643|OTHER|Efficacy of the HZ/su vaccine against use of pain medications was demonstrated if the LL of the two-sided 95% CI of VE was above 0%.|Vaccine efficacy|43.42||||0.0112|TWO_SIDED|95.0|10.77|70.53|||Poisson exact test|||Comparison of VE in reduction in use of pain medication between Zoster-022 GSK1437173A 70-79YOA Group and Zoster-022 Placebo 70-79YOA Group||70.53|10.77|0.0112
72564600|NCT01730040|144660711|SUPERIORITY_OR_OTHER||LS Mean Difference|2.9|||=|0.4456|TWO_SIDED|99.0|-7.0|12.9||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant) for atorvastatin 40 mg baseline stratification).||12.9|-7.0|=0.4456
72564601|NCT01552369|144660778|SUPERIORITY|||||||0.0396|||||||Mantel Haenszel|||||||0.0396
72564602|NCT01552369|144660778|SUPERIORITY||Hazard Ratio (HR)|2.22||||0.048|TWO_SIDED|95.0|1.01|7.3|||Competing risk regression|Death was considered a competing risk.|The risk of CMV disease is 2.2x higher in the prophylaxis group when compared to the preemptive group|||7.3|1.01|0.048
72564603|NCT01552369|144660779|SUPERIORITY|log-rank test for equality of survivor functions||||||0.19|||||||Log Rank|||||||0.19
72564604|NCT01552369|144660780|SUPERIORITY||Odds Ratio (OR)|0.85||||0.6|TWO_SIDED|95.0|0.45|1.58|||Mantel Haenszel||The odds of rejection in prophylaxis group compared to preemptive group|||1.58|0.45|0.60
72466407|NCT03463577|144456034|SUPERIORITY|The objective was to explore differences (superiority testing) in the incidence rate of each of the maternal and infant adverse events, among vaccinated women with Boostrix and their infants as compared to the incidence in a matched cohort of unvaccinated women and their infants. The null hypothesis H0 RR=1 was rejected if lower limit of 95% CI for adjusted RR was above 1.|Risk Ratio (RR)|1.5||||||95.0|1.21|1.86|||||Adjusted RR with 95% CI-Poisson regression model|Assessment of adjusted RR for congenital anomalies of musculoskeletal system in Exposed infants cohort (on or after 1st day of 27th week of pregnancy) compared to Unexposed historical infants cohort was 1 or differed from 1 (superiority testing).||1.86|1.21|
72466408|NCT03463577|144456034|SUPERIORITY|The objective was to explore differences (superiority testing) in the incidence rate of each of the maternal and infant adverse events, among vaccinated women with Boostrix and their infants as compared to the incidence in a matched cohort of unvaccinated women and their infants. The null hypothesis H0 RR=1 was rejected if lower limit of 95% CI for adjusted RR was above 1.|Risk Ratio (RR)|1.13|||||TWO_SIDED|95.0|0.85|1.52|||||Adjusted RR with 95% CI-Poisson regression model|Assessment of adjusted RR for congenital anomalies of limb in Exposed infants cohort (on or after 1st day of 27th week of pregnancy) compared to Unexposed historical infants cohort was 1 or differed from 1 (superiority testing).||1.52|0.85|
72466409|NCT03463577|144456034|SUPERIORITY|The objective was to explore differences (superiority testing) in the incidence rate of each of the maternal and infant adverse events, among vaccinated women with Boostrix and their infants as compared to the incidence in a matched cohort of unvaccinated women and their infants. The null hypothesis H0 RR=1 was rejected if lower limit of 95% CI for adjusted RR was above 1.|Risk Ratio (RR)|1.98|||||TWO_SIDED|95.0|1.76|2.23|||||Adjusted RR with 95% CI-Poisson regression model|Assessment of adjusted RR for congenital anomalies of integument in Exposed infants cohort (on or after 1st day of 27th week of pregnancy) compared to Unexposed historical infants cohort was 1 or differed from 1 (superiority testing).||2.23|1.76|
72466410|NCT03463577|144456034|SUPERIORITY|The objective was to explore differences (superiority testing) in the incidence rate of each of the maternal and infant adverse events, among vaccinated women with Boostrix and their infants as compared to the incidence in a matched cohort of unvaccinated women and their infants. The null hypothesis H0 RR=1 was rejected if lower limit of 95% CI for adjusted RR was above 1.|Risk Ratio (RR)|1.09|||||TWO_SIDED|95.0|0.64|1.85|||||Adjusted RR with 95% CI-Poisson regression model|Assessment of adjusted RR for other and unspecified congenital anomalies in Exposed infants cohort (on or after 1st day of 27th week of pregnancy) compared to Unexposed historical infants cohort was 1 or differed from 1 (superiority testing).||1.85|0.64|
72466411|NCT05694533|144456038|OTHER|Descriptive only.|Geometric Mean Ratio|0.84|||||TWO_SIDED|90.0|0.76|0.92||||A random effects model was used to calculate the confidence interval.|Day 15/Day 1|The comparison is between Midazolam on Day 15 and Midazolam on Day 1.||0.92|0.76|
72466412|NCT05694533|144456038|OTHER|Descriptive only.|Geometric Mean Ratio|0.8|||||TWO_SIDED|90.0|0.69|0.93||||A random effects model was used to calculate the confidence interval.|Day 15/Day 1|The comparison is between 1-hydroxymidazolam on Day 15 and 1-hydroxymidazolam on Day 1.||0.93|0.69|
72466413|NCT05694533|144456039|OTHER|Descriptive only.|Geometric Mean Ratio|0.85|||||TWO_SIDED|90.0|0.78|0.92||||A random effects model was used to calculate the confidence interval.|Day 15/Day 1|The comparison is between Midazolam on Day 15 and Midazolam on Day 1.||0.92|0.78|
72466414|NCT05694533|144456039|OTHER|Descriptive only.|Geometric Mean Ratio|0.81|||||TWO_SIDED|90.0|0.74|0.89||||A random effects model was used to calculate the confidence interval.|Day 15/Day 1|The comparison is between 1-hydroxymidazolam on Day 15 and 1-hydroxymidazolam on Day 1.||0.89|0.74|
72466415|NCT05694533|144456040|OTHER|Descriptive only.|Geometric Mean Ratio|0.85|||||TWO_SIDED|90.0|0.78|0.91||||A random effects model was used to calculate the confidence interval.|Day 15/Day 1|The comparison is between Midazolam on Day 15 and Midazolam on Day 1.||0.91|0.78|
72503437|NCT01165229|144537643|OTHER|Efficacy of the HZ/su vaccine against use of pain medications was demonstrated if the LL of the two-sided 95% CI of the VE was above 0%|Vaccine efficacy|27.03||||0.3903|TWO_SIDED|95.0|-26.43|73.2|||Poisson exact test|||Comparison of VE in reduction in use of pain medication between Zoster-022 GSK1437173A \>=80YOA Group and Zoster-022 Placebo \>=80YOA Group||73.20|-26.43|0.3903
72503438|NCT01165229|144537643|OTHER|Efficacy of the HZ/su vaccine against use of pain medications was demonstrated if the LL of the two-sided 95% CI of VE was above 0%.|Vaccine efficacy|39.6||||0.0083|TWO_SIDED|95.0|10.79|64.75|||Poisson exact test|||Comparison of VE in reduction in use of pain medication between Zoster-022 GSK1437173A \>=70YOA group and Zoster-022 Placebo \>=70YOA Group||64.75|10.79|0.0083
72466416|NCT05694533|144456040|OTHER|Descriptive only.|Geometric Mean Ratio|0.87|||||TWO_SIDED|90.0|0.78|0.97||||A random effects model was used to calculate the confidence interval.|Day 15/Day 1|The comparison is between 1-hydroxymidazolam on Day 15 and 1-hydroxymidazolam on Day 1.||0.97|0.78|
72466417|NCT01101997|144456042|SUPERIORITY||sucess proportion|0.853|||<|0.001|TWO_SIDED|95.0|0.773|0.91|||Chi-squared|||H0: p= 0.6 and Ha: p ≠ 0.6||.910|.773|<0.001
72466418|NCT01101997|144456043|OTHER||Mean Difference (Net)|-1.9|STANDARD_DEVIATION|2.49|||TWO_SIDED|||||||||||||
72466419|NCT00107978|144456071|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin of 10% was specified based on historical regulatory precedent.|Risk Difference (RD)|2.5||||||95.0|-2.9|7.9||p-values were not calculated in deference to confidence intervals.|2-sided 95% confidence interval|2-sided 95% confidence interval calculated on the difference in cure rates between treatment groups.||||7.9|-2.9|
72466420|NCT00704171|144456085|SUPERIORITY_OR_OTHER|||||||0.257|||||||Fisher Exact|||Primary objective was to demonstrate superiority of PleuraSeal as an adjunct compared to standard of care alone. Tissue closure rates for the treatment and control groups were assumed to be 0.40 and 0.15, respectively. To achieve 80 percent power (alpha=0.05, 2-tailed, Fisher's Exact Test) required 112 completed subjects. To account for potential subject withdrawals, an additional 8 subjects were to be enrolled for a total of 120 randomized subjects (approx. 60 per treatment group).||||0.257
72466421|NCT00704171|144456086|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Fisher Exact|two-sided||||||<0.001
72503439|NCT01165229|144537644|OTHER|Efficacy of the HZ/su vaccine against duration of pain medication associated with HZ was demonstrated if the LL of the two-sided 95% CI of VE derived from the hazard ratio was above 0%.|Vaccine efficacy|58.94||||0.0232|TWO_SIDED|95.0|11.45|80.96|||Poisson exact test|||Comparison of VE in reduction in duration of pain medication associated with HZ between Zoster-022 GSK1437173A 70-79YOA Group and Zoster-022 Placebo 70-79YOA Group||80.96|11.45|0.0232
72394550|NCT02310568|144295790|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.1|STANDARD_ERROR_OF_MEAN|2.16||0.353|TWO_SIDED|90.0|-5.8|1.7|||ANCOVA|||(PF-06372865 2.5 mg - Placebo). Total Score (Combined Stage 1 and Stage 2): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.||1.7|-5.8|0.353
72394551|NCT02310568|144295790|SUPERIORITY_OR_OTHER||LS Mean Difference|2.1|STANDARD_ERROR_OF_MEAN|1.92||0.296|TWO_SIDED|90.0|-1.3|5.4|||ANCOVA|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Total Score (Combined Stage 1 and Stage 2): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.||5.4|-1.3|0.296
72394552|NCT02310568|144295790|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.95||0.841|TWO_SIDED|90.0|-1.8|1.5|||ANCOVA|||(PF-06372865 7.5 mg - Placebo). Social Sub-Scale Score (Combined Stage 1 and Stage 2): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.||1.5|-1.8|0.841
72394553|NCT02310568|144295790|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.95||0.332|TWO_SIDED|90.0|-2.6|0.7|||ANCOVA|||(PF-06372865 2.5 mg - Placebo). Social Sub-Scale Score (Combined Stage 1 and Stage 2): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.||0.7|-2.6|0.332
72394554|NCT02310568|144295790|SUPERIORITY_OR_OTHER||LS Mean Difference|0.8|STANDARD_ERROR_OF_MEAN|0.81||0.359|TWO_SIDED|90.0|-0.6|2.2|||ANCOVA|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Social Sub-Scale Score (Combined Stage 1 and Stage 2): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.||2.2|-0.6|0.359
72394555|NCT02310568|144295790|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.78||0.347|TWO_SIDED|90.0|-2.1|0.6|||ANCOVA|||(PF-06372865 7.5 mg - Placebo). Work Sub-Scale Score (Combined Stage 1 and Stage 2): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.||0.6|-2.1|0.347
72394556|NCT02310568|144295790|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.8|STANDARD_ERROR_OF_MEAN|0.8||0.041|TWO_SIDED|90.0|-3.2|-0.4|||ANCOVA|||(PF-06372865 2.5 mg - Placebo). Work Sub-Scale Score (Combined Stage 1 and Stage 2): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.||-0.4|-3.2|0.041
72394557|NCT02310568|144295790|SUPERIORITY_OR_OTHER||LS Mean Difference|1.0|STANDARD_ERROR_OF_MEAN|0.79||0.212|TWO_SIDED|90.0|-0.4|2.4|||ANCOVA|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Work Sub-Scale Score (Combined Stage 1 and Stage 2): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.||2.4|-0.4|0.212
72394558|NCT02310568|144295790|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.69||0.954|TWO_SIDED|90.0|-1.2|1.2|||ANCOVA|||(PF-06372865 7.5 mg - Placebo). Family Sub-Scale Score (Combined Stage 1 and Stage 2): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.||1.2|-1.2|0.954
72466422|NCT00704171|144456087|SUPERIORITY_OR_OTHER|||||||0.79|||||||Kaplan-Meier|Kaplan-Meier method was used to obtain estimated median times for each treatment group and the log-rank test was used to compare the two treatments.||||||0.790
72466423|NCT00704171|144456088|SUPERIORITY_OR_OTHER|||||||0.559|||||||2-sample t-test|||||||0.559
72466424|NCT00704171|144456089|SUPERIORITY_OR_OTHER|||||||0.292|||||||2-sample t-test|||||||0.292
72564605|NCT01552369|144660781|SUPERIORITY||Odds Ratio (OR)|0.95||||0.96|TWO_SIDED|95.0|0.13|6.92|||Mantel Haenszel||The odds of graft loss in prophylaxis group compared to preemptive group|||6.92|0.13|0.96
72466425|NCT00704171|144456090|SUPERIORITY_OR_OTHER|||||||0.53||||||For subgroup with pre-randomization air leak grade of 1|Fisher Exact|||||||0.53
72466426|NCT00704171|144456090|SUPERIORITY_OR_OTHER|||||||0.013||95.0||||For subgroup with pre-randomization air leak grade of 2 or 3|Fisher Exact|||||||.013
72466427|NCT04269434|144456112|NON_INFERIORITY|"The No Screening Arm is considered non-inferior if the upper limit of the 95% Confidence Interval is less than 1.25"|Incidence rate ratio|1.318|||||TWO_SIDED|95.0|1.068|1.627||||||Compared to screening group||1.627|1.068|
72466428|NCT04269434|144456113|NON_INFERIORITY|No prespecified margin|Incidence rate ratio|0.788|||||TWO_SIDED|95.0|0.719|0.863||||||For Azithromycin. Compared to screening group||0.863|0.719|
72466429|NCT04269434|144456113|NON_INFERIORITY|No prespecified margin|Incidence rate ratio|0.561|||||TWO_SIDED|95.0|0.426|0.739||||||For Ceftriaxone. Compared to screening group||0.739|0.426|
72466430|NCT04269434|144456113|NON_INFERIORITY|No prespecified margin|Incidence rate ratio|0.55|||||TWO_SIDED|95.0|0.515|0.588||||||For Doxycycline. Compared to screening group||0.588|0.515|
72466431|NCT04269434|144456114|NON_INFERIORITY|No prespecified margin.|Incidence rate ratio|1.373|||||TWO_SIDED|95.0|0.963|1.956||||||Compared to screening group||1.956|0.963|
72394559|NCT02310568|144295790|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.7||0.407|TWO_SIDED|90.0|-1.8|0.6|||ANCOVA|||(PF-06372865 2.5 mg - Placebo). Family Sub-Scale Score (Combined Stage 1 and Stage 2): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.||0.6|-1.8|0.407
72466432|NCT04269434|144456115|NON_INFERIORITY|No prespecified margin.|Incidence rate ratio|1.471|||||TWO_SIDED|95.0|0.943|2.299||||||Compared to screening group||2.299|0.943|
72466433|NCT04962698|144456116|SUPERIORITY||||||>|0.00238||||||The threshold for statistical significance was 0.00238, which was adjusted from the original 0.05 as described below.|Wilcoxon (Mann-Whitney)|The alpha value for p-value comparison was adjusted for 21 pair-wise comparisons (0.05/21 = 0.00238) across seven tasks.||||||>0.00238
72503440|NCT01165229|144537644|OTHER|Efficacy of the HZ/su vaccine against duration of pain medication associated with HZ was demonstrated if the LL of the two-sided 95% CI of VE derived from the hazard ratio was above 0%.|Vaccine efficacy|-14.56||||0.8324|TWO_SIDED|95.0|-303.3|67.46|||Poisson exact test|||Comparison of VE in reduction in duration of pain medication associated with HZ between Zoster-022 GSK1437173A \>=80YOA Group and Zoster-022 Placebo \>=80YOA Group||67.46|-303.30|0.8324
72503441|NCT01165229|144537644|OTHER|Efficacy of the HZ/su vaccine against duration of pain medication associated with HZ was demonstrated if the LL of the two-sided 95% CI of VE derived from the hazard ratio was above 0%.|Vaccine efficacy|49.25||||0.0404|TWO_SIDED|95.0|2.92|73.47|||Poisson exact test|||Comparison of VE in reduction in duration of pain medication associated with HZ between Zoster-022 GSK1437173A \>=70YOA Group and Zoster-022 Placebo \>=70YOA Group||73.47|2.92|0.0404
72503442|NCT01165229|144537653|OTHER|The efficacy of HZ/su vaccine against PHN was demonstrated if the lower limit of the of the 2-sided 95% CI of VE was above 0%|Vaccine efficacy|100.0||||0.0081|TWO_SIDED|95.0|40.88|100.0|||Poisson exact test|||Comparison of vaccine efficacy in prevention of PHN between Zoster-022/006 Pooled GSK1437173A 50-59YOA Group and Zoster-022/006 Pooled Placebo 50-59YOA Group.Comparison of vaccine efficacy for groups 70-79 and above 80 YOA are presented in outcome measure 2.||100.00|40.88|0.0081
72503443|NCT01165229|144537653|OTHER|The efficacy of HZ/su vaccine against PHN was demonstrated if the lower limit of the of the 2-sided 95% CI of VE was above 0%|Vaccine efficacy|100.0||||0.5097|TWO_SIDED|95.0|-442.83|100.0|||Poisson exact test|||Comparison of vaccine efficacy in prevention of PHN between Zoster-022/006 Pooled GSK1437173A 60-69YOA Group and Zoster-022/006 Pooled Placebo 60-69YOA Group||100.00|-442.83|0.5097
72503444|NCT01165229|144537654|OTHER|The efficacy of HZ/su vaccine in reduction of PHN in subjects with confirmed HZ episodes was demonstrated if the LL of the two-sided 95% CI of VE was above 0%|Vaccine efficacy|100.0||||1|TWO_SIDED|95.0|-649.86|100.0|||Poisson exact test|||Comparison of Vaccine efficacy in reduction of PHN incidence in subjects with confirmed HZ episode in Zoster-022/006 Pooled GSK1437173A 50-59 YOA Group versus Zoster-022/006 Pooled Placebo 50-59 YOA Group||100.00|-649.86|1.0000
72503445|NCT01165229|144537654|OTHER|The efficacy of HZ/su vaccine in reduction of PHN in subjects with confirmed HZ episodes was demonstrated if the LL of the two-sided 95% CI of VE was above 0%|Vaccine efficacy|100.0||||1|TWO_SIDED|95.0|-3938.7|100.0|||Poisson exact test|||Comparison of Vaccine efficacy in reduction of PHN incidence in subjects with confirmed HZ episode in Zoster-022/006 Pooled GSK1437173A 60-69 YOA Group versus Zoster-022/006 Pooled Placebo 60-69 YOA Group||100.00|-3938.70|1.0000
72466434|NCT04962698|144456117|SUPERIORITY||||||<|0.001||||||The threshold for statistical significance was 0.05.|ANOVA|||||||<0.001
72564606|NCT01552369|144660782|SUPERIORITY||Odds Ratio (OR)|3.24||||0.014|TWO_SIDED|95.0|1.21|8.69|||Mantel Haenszel||Odds of late disease in prophylaxis group compared to preemptive|||8.69|1.21|0.014
72466435|NCT04962698|144456118|SUPERIORITY|||||||0.028||||||The threshold for statistical significance was 0.05.|ANOVA|||||||0.028
72466436|NCT04962698|144456119|SUPERIORITY||||||<|0.00231||||||The threshold for statistical significance was 0.00238, which was adjusted from the original 0.05 as described below.|Wilcoxon (Mann-Whitney)|The alpha value for p-value comparison was adjusted for 21 pair-wise comparisons (0.05/21 = 0.00238) across seven tasks.||||||<0.00231
72503446|NCT01165229|144537654|OTHER|The efficacy of HZ/su vaccine in reduction of PHN in subjects with confirmed HZ episodes was demonstrated if the LL of the two-sided 95% CI of VE was above 0%|Vaccine efficacy|21.6||||1|TWO_SIDED|95.0|-149.41|78.91|||Poisson exact test|||Comparison of Vaccine efficacy in reduction of PHN incidence in subjects with confirmed HZ episode in Zoster-022/006 Pooled GSK1437173A 70-79 YOA Group versus Zoster-022/006 Pooled Placebo 70-79 YOA Group||78.91|-149.41|1.0000
72503447|NCT01165229|144537654|OTHER|The efficacy of HZ/su vaccine in reduction of PHN in subjects with confirmed HZ episodes was demonstrated if the LL of the two-sided 95% CI of VE was above 0%|Vaccine efficacy|-223.81||||0.1528|TWO_SIDED|95.0|-883.05|18.84|||Poisson exact test|||Comparison of Vaccine efficacy in reduction of PHN incidence in subjects with confirmed HZ episode in Zoster-022/006 Pooled GSK1437173A \>=80 YOA Group versus Zoster-022/006 Pooled Placebo\>=80 YOA Group||18.84|-883.05|0.1528
72503448|NCT01165229|144537654|OTHER|The efficacy of HZ/su vaccine in reduction of PHN in subjects with confirmed HZ episodes was demonstrated if the LL of the two-sided 95% CI of VE was above 0%|Vaccine efficacy|0.29||||0.5417|TWO_SIDED|95.0|-161.53|65.57|||Poisson exact test|||Comparison of Vaccine efficacy in reduction of PHN incidence in subjects with confirmed HZ episode in Zoster-022/006 Pooled GSK1437173A \>=50 YOA Group versus Zoster-022/006 Pooled Placebo \>=50 YOA Group||65.57|-161.53|0.5417
72466437|NCT04962698|144456120|SUPERIORITY||||||<|0.002||||||The threshold for statistical significance was 0.00238, which was adjusted from the original 0.05 as described below.|Wilcoxon (Mann-Whitney)|The alpha value for p-value comparison was adjusted for 21 pair-wise comparisons (0.05/21 = 0.00238) across seven tasks.||||||<0.0020
72466438|NCT01664923|144456184|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.24|||<|0.0001|TWO_SIDED|95.0|0.181|0.32||P-value based on log-rank test stratified by disease stage at study entry as reported on the case report form (CRF).|Log Rank||Hazard ratio is based on a Cox regression model (with treatment as the only covariate) stratified by disease stage at study entry and is relative to bicalutamide with \< 1 favoring enzalutamide.|||0.320|0.181|<0.0001
72466439|NCT01664923|144456185|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.19|||<|0.0001|TWO_SIDED|95.0|0.137|0.264||P-value based on log-rank test stratified by disease stage at study entry as reported on the CRF.|Log Rank||Hazard ratio is based on a Cox regression model (with treatment as the only covariate) stratified by disease stage at study entry and is relative to bicalutamide with \< 1 favoring enzalutamide.|||0.264|0.137|<0.0001
72466440|NCT01664923|144456186|SUPERIORITY_OR_OTHER||Difference in rates|50.0|||<|0.0001|TWO_SIDED|95.0|41.4|58.5|||Cochran-Mantel-Haenszel|Comparison of the 2 treatment groups using the Cochran-Mantel-Haenszel mean score test stratified by disease stage at study entry.|Enzalutamide response rate minus bicalutamide response rate.|||58.5|41.4|<0.0001
72466441|NCT01664923|144456187|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.324|||<|0.0001|TWO_SIDED|95.0|0.211|0.497|||Log Rank|P-value is based on an unstratified log-rank test.|Hazard ratio is based on an unstratified Cox-regression model (with treatment as the only covariate) and is relative to bicalutamide with \< 1 favoring enzalutamide.|||0.497|0.211|<0.0001
72466442|NCT01664923|144456188|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.91||||0.4945|TWO_SIDED|95.0|0.695|1.192||This secondary endpoint was not adjusted for multiple comparisons.|Log Rank|P-value is based on a log-rank test stratified by disease stage at study entry.|Hazard ratio is based on a Cox regression model (with treatment as the only covariate) stratified by disease stage at study entry and is relative to bicalutamide with \< 1 favoring enzalutamide.|||1.192|0.695|0.4945
72466443|NCT01664923|144456189|SUPERIORITY_OR_OTHER||Difference in objective response rate|46.05|||<|0.0001|TWO_SIDED|95.0|26.79|65.3||This secondary endpoint was not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Based on unstratified Cochran-Mantel-Haenszel mean score test.||||65.30|26.79|<0.0001
72466444|NCT03231969|144456192|SUPERIORITY||Mean Difference (Final Values)|-0.791||||0.0002|TWO_SIDED|95.0|-1.203|-0.378|||ANCOVA|||Treatment difference (95%CI): Bilastine 0.2% arm minus Bilastine 0% (Vehicle) arm at Visit 4b (including all time points).||-0.378|-1.203|0.0002
72466445|NCT03231969|144456192|SUPERIORITY||Mean Difference (Final Values)|-0.851|||<|0.0001|TWO_SIDED|95.0|-1.263|-0.439|||ANCOVA|||Treatment difference (95%CI): Bilastine 0.4% arm minus Bilastine 0% (Vehicle) arm at Visit 4b (including all time points).||-0.439|-1.263|<.0001
72564607|NCT01552369|144660783|SUPERIORITY||Odds Ratio (OR)|1.17||||0.64|TWO_SIDED|95.0|0.61|2.23|||Mantel Haenszel||Odds of bacterial infection in prophylaxis subjects compared to preemptive|||2.23|0.61|0.64
72564608|NCT01552369|144660784|SUPERIORITY||Odds Ratio (OR)|2.25||||0.18|TWO_SIDED|95.0|0.66|7.62|||Mantel Haenszel||Odds of fungal disease in prophylaxis group compared to preemptive|||7.62|0.66|0.18
72466446|NCT03231969|144456192|SUPERIORITY||Mean Difference (Final Values)|-1.545|||<|0.0001|TWO_SIDED|95.0|-1.954|-1.135|||ANCOVA|||Treatment difference (95%CI): Bilastine 0.6% arm minus Bilastine 0% (Vehicle) arm at Visit 4b (including all time points).||-1.135|-1.954|<.0001
72466447|NCT03231969|144456192|SUPERIORITY||Mean Difference (Final Values)|-1.208|||<|0.0001|TWO_SIDED|95.0|-1.639|-0.778|||ANCOVA|||Treatment difference (95%CI): Bilastine 0.2% arm minus Bilastine 0% (Vehicle) arm at Visit 5b (including all time points).||-0.778|-1.639|<.0001
72466448|NCT03231969|144456192|SUPERIORITY||Mean Difference (Final Values)|-1.245|||<|0.0001|TWO_SIDED|95.0|-1.679|-0.811|||ANCOVA|||Treatment difference (95%CI): Bilastine 0.4% arm minus Bilastine 0% (Vehicle) arm at Visit 5b (including all time points).||-0.811|-1.679|<.0001
72564609|NCT01552369|144660785|SUPERIORITY|||||||0.24|||||||Fisher Exact|||||||0.24
72564610|NCT01552369|144660786|SUPERIORITY|||||||0.69|||||||Chi-squared|||||||0.69
72466449|NCT03231969|144456192|SUPERIORITY||Mean Difference (Final Values)|-1.846|||<|0.0001|TWO_SIDED|95.0|-2.273|-1.418|||ANCOVA|||Treatment difference (95%CI): Bilastine 0.6% arm minus Bilastine 0% (Vehicle) arm at Visit 5b (including all time points).||-1.418|-2.273|<.0001
72466450|NCT03231969|144456192|SUPERIORITY||Mean Difference (Final Values)|-1.696|||<|0.0001|TWO_SIDED|95.0|-2.08|-1.312|||ANCOVA|||Treatment difference (95%CI): Bilastine 0.2% arm minus Bilastine 0% (Vehicle) arm at Visit 6 (including all time points).||-1.312|-2.080|<.0001
72466451|NCT03231969|144456192|SUPERIORITY||Mean Difference (Final Values)|-1.617|||<|0.0001|TWO_SIDED|95.0|-2.001|-1.232|||ANCOVA|||Treatment difference (95%CI): Bilastine 0.4% arm minus Bilastine 0% (Vehicle) arm at Visit 6 (including all time points).||-1.232|-2.001|<.0001
72466452|NCT03231969|144456192|SUPERIORITY||Mean Difference (Final Values)|-2.009|||<|0.0001|TWO_SIDED|95.0|-2.387|-1.63|||ANCOVA|||Treatment difference (95%CI): Bilastine 0.6% arm minus Bilastine 0% (Vehicle) arm at Visit 6 (including all time points).||-1.630|-2.387|<.0001
72466453|NCT03247738|144456193|SUPERIORITY|The primary end point of our study was the comparison of platelet reactivity measured by VerifyNow PRU between cangrelor and placebo at 30 minutes after drugs were administered at the start of PCI. Assuming a common standard deviation of 70 PRU, a sample size of 20 patients per group would allow detection of a 70 PRU difference between groups with 85% power and a two-sided α = 0.05. Considering the 2 arms and a possible 25% rate of invalid PD results we planned to randomize up to 50 patients.|Mean Difference (Net)|152.0|||<|0.001|TWO_SIDED|95.0|108.0|195.0|||ANCOVA|the baseline value of platelet reactivity used as a covariate||||195|108|<0.001
72466454|NCT00129649|144456200|SUPERIORITY|||||||0.004|||||||Chi-squared|||||||0.004
72466455|NCT02561806|144456217|NON_INFERIORITY|Non-inferiority margin was -12.6% for 97.5% confidence interval|Risk Difference (RD)|0.321|||<|0.001|TWO_SIDED|97.5|0.198|0.445|||Regression, Logistic|||||0.445|0.198|<0.001
72466456|NCT02561806|144456218|SUPERIORITY||Risk Ratio (RR)|1.285|||<|0.001|TWO_SIDED|95.0|1.13|1.439|||Regression, Logistic|||||1.439|1.130|<0.001
72466457|NCT02561806|144456219|SUPERIORITY||Risk Ratio (RR)|2.699||||0.009|TWO_SIDED|95.0|1.423|3.975|||Regression, Logistic|||||3.975|1.423|0.009
72466458|NCT02561806|144456220|SUPERIORITY||Risk Ratio (RR)|1.469|||<|0.001|TWO_SIDED|95.0|1.244|1.695|||Regression, Logistic|||||1.695|1.244|<0.001
72564611|NCT01552369|144660787|SUPERIORITY|||||||0.57|||||||Chi-squared|||||||0.57
72564612|NCT01552369|144660788|SUPERIORITY|||||||0.61|||||||Chi-squared|||||||0.61
72466459|NCT02561806|144456221|SUPERIORITY||Risk Ratio (RR)|3.421||||0.021|TWO_SIDED|95.0|1.353|5.488|||Regression, Logistic|||||5.488|1.353|0.021
72466460|NCT02561806|144456228|SUPERIORITY||Risk Ratio (RR)|1.391||||0.012|TWO_SIDED|95.0|1.085|1.698|||Regression, Logistic|||||1.698|1.085|0.012
72466461|NCT02547441|144456241|SUPERIORITY|||||||0.043|||||||ANCOVA|||||||0.043
72466462|NCT02547441|144456242|SUPERIORITY|||||||0.019|||||||Cochran-Mantel-Haenszel|||||||0.019
72466463|NCT01322009|144456251|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|Analysis run over study period but data entered only for the 6 h time point||||||>0.05
72466464|NCT00511797|144456273|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.92|STANDARD_ERROR_OF_MEAN|0.29|<|0.001|TWO_SIDED|95.0|-1.49|-0.34||Pre-defined sequential tests were applied to protect alpha inflation by multiplicity.|t-test, 1 sided|||Three null hypotheses were sequentially tested. H01: DRSP 3 mg \>= Placebo (Active is equal or less in decrease of score) vs H11: DRSP 3 mg \< Placebo (Active is greater in decrease of score), H02: DRSP 2 mg \>= Placebo vs H12: DRSP 2 mg \< Placebo, H03: DRSP 1 mg \>= Placebo vs H13: DRSP 1 mg \< Placebo.||-0.34|-1.49|<0.001
72466465|NCT00511797|144456273|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-1.1|STANDARD_ERROR_OF_MEAN|0.277|<|0.001||95.0|-1.64|-0.55|||t-test, 1 sided|||Second null hypothesis was tested. H02: DRSP 2 mg \>= Placebo vs H12: DRSP 2 mg \< Placebo.||-0.55|-1.64|<0.001
72466466|NCT00511797|144456273|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-1.44|STANDARD_ERROR_OF_MEAN|0.28|<|0.001||95.0|-2.0|-0.89|||t-test, 1 sided|||Third null hypotheses was tested. H03: DRSP 1 mg \>= Placebo vs H13: DRSP 1 mg \< Placebo.||-0.89|-2.00|<0.001
72466467|NCT00511797|144456274|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.1|STANDARD_ERROR_OF_MEAN|0.322|<|0.001|TWO_SIDED|95.0|-1.74|-0.46|||t-test, 1 sided|||Test results of 3 mg DRSP and placebo at Cycle 4 are shown. 2-sided 95% confidence intervals were calculated. To keep consistency with 2-sided 95% confidence intervals, 2.5% 1-sided significance levels were used for the statistical tests.||-0.46|-1.74|<0.001
72466468|NCT00511797|144456274|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.34|STANDARD_ERROR_OF_MEAN|0.306|<|0.001||95.0|-1.95|-0.73|||t-test, 1 sided|||||-0.73|-1.95|<0.001
72564613|NCT02631837|144660797|NON_INFERIORITY|Our hypothesis was that women would accept a higher conversion rate of 15% for vNOTESbased on a telephone interview of 10 women treated by total vaginal NOTES hysterectomy. Women were asked to choose among ﬁve cut-off rates (5, 10, 15, 20 or 25%). Most women indicated 15%. We would conclude non-inferiority when the upper limit of the one-sided 95% conﬁdence interval for the difference in the proportions of women between both comparisons would be below 15%.||||||0.0221||||||The Farrington-Manning test for non-inferiority was performed with 5% significance level and yielded P = 0.0221 in a sensitivity analysis assuming one conversion in the vNOTES and 0 conversions in the laparoscopy group.|Farrington-Manning|||||||0.0221
72466469|NCT00511797|144456274|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.53|STANDARD_ERROR_OF_MEAN|0.317|<|0.001||95.0|-2.16|-0.9|||t-test, 1 sided|||||-0.90|-2.16|<0.001
72466470|NCT03974100|144456297|EQUIVALENCE|Equivalence criteria (analysis set PPS): 95% CI for difference in means contained in \[-1.45%, 1.45%\]|Mean Difference (Final Values)|-0.145|STANDARD_ERROR_OF_MEAN|0.3325|||TWO_SIDED|95.0|-0.798|0.509|||Mixed-model repeated measures (MMRM)|MMRM included treatment, prior bisphosphonate use, DXA machine type, visit, visit-treatment interaction, and baseline LS-BMD as a continuous covariate|Difference GP2411 (Test) - EU-Prolia (Reference)|||0.509|-0.798|
72466471|NCT03974100|144456298|EQUIVALENCE|Equivalence criteria (analysis set TP1 FAS): 95% CI for difference in means contained in \[-1.45%, 1.45%\] (criteria 1) or in \[-2.00%, 2.00%\] (criteria 2)|Mean Difference (Final Values)|-0.177|STANDARD_ERROR_OF_MEAN|0.3321|||TWO_SIDED|95.0|-0.83|0.475|||Mixed-model repeated measures (MMRM)|MMRM included treatment, prior bisphosphonate use, DXA machine type, visit, visit-treatment interaction, and baseline LS-BMD as a continuous covariate|Difference GP2411 (Test) - EU-Prolia (Reference)|||0.475|-0.830|
72466472|NCT03974100|144456299|EQUIVALENCE|Equivalence criteria (analysis set PDS): 95% CI for ratio of geometric means contained in \[0.80, 1.25%\]|Geometric mean ratio|1.0|||||TWO_SIDED|95.0|0.98|1.01|||ANCOVA|ANCOVA was performed on log-transformed AUEC including treatment and log baseline CTX value as a continuous covariate|Geometric mean ratio of GP2411 (Test) to EU-Prolia (Reference)|||1.01|0.98|
72466473|NCT03974100|144456299|EQUIVALENCE|Equivalence criteria (analysis set PDS): 90% CI for ratio of geometric means contained in \[0.80, 1.25%\]|Geometric mean ratio|1.0|||||TWO_SIDED|90.0|0.98|1.01|||ANCOVA|ANCOVA was performed on log-transformed AUEC including treatment and log baseline CTX value as a continuous covariate|Geometric mean ratio of GP2411 (Test) to EU-Prolia (Reference)|||1.01|0.98|
72466474|NCT03974100|144456300|EQUIVALENCE|Equivalence criteria (analysis set PKS): 90% CI for ratio of geometric means contained in \[0.80, 1.25%\]|Geometric mean ratio|0.97|||||TWO_SIDED|90.0|0.92|1.03|||ANCOVA|ANCOVA was performed on log-transformed Cmax including treatment and weight as a continuous covariate|Geometric mean ratio of GP2411 (Test) to EU-Prolia (Reference)|||1.03|0.92|
72466475|NCT03974100|144456301|EQUIVALENCE|Equivalence criteria (analysis set PKS): 90% CI for ratio of geometric means contained in \[0.80, 1.25%\]|Geometric mean ratio|0.99|||||TWO_SIDED|90.0|0.93|1.05|||ANCOVA|ANCOVA was performed on log-transformed AUCinf including treatment and weight as a continuous covariate|Geometric mean ratio of GP2411 (Test) to EU-Prolia (Reference)|||1.05|0.93|
72466476|NCT02024750|144456344|OTHER||Mean Difference (Net)|0.005||||0.72|TWO_SIDED|95.0|-0.021|0.03||The a priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|Adjustments were made for study stratification variables and covariates that were imbalanced between study arms at baseline.|Negative values indicate a clinical benefit.|During the intervention period, the treatment effect on A1c. Results reflect the difference in A1c trend between usual care and intervention arms.||0.030|-0.021|0.72
72466477|NCT02024750|144456344|OTHER||Mean Difference (Net)|-0.01||||0.38|TWO_SIDED|95.0|-0.034|0.013||The a priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|Adjustments were made for study stratification variables and covariates that were imbalanced between study arms at baseline.|Negative values indicate a clinical benefit.|During the post-intervention period, the treatment effect on A1c. Results reflect the difference in A1c trend between usual care and intervention arms.||0.013|-0.034|0.38
72466478|NCT02024750|144456345|OTHER||Mean Difference (Net)|0.023||||0.87|TWO_SIDED|95.0|-0.249|0.295||The a priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|Adjustments were made for study stratification variables and covariates that were imbalanced between study arms at baseline.|Positive values indicate a clinical benefit.|During the intervention period, the treatment effect on child quality of life. Results reflect the difference in QOL trend between usual care and intervention arms.||0.295|-0.249|0.87
72466479|NCT02024750|144456345|OTHER||Mean Difference (Net)|-0.074||||0.74|TWO_SIDED|95.0|-0.517|0.369||The a priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|Adjustments were made for study stratification variables and covariates that were imbalanced between study arms at baseline.|Positive values indicate a clinical benefit.|During the post-intervention period, the treatment effect on child quality of life. Results reflect the difference in QOL trend between usual care and intervention arms.||0.369|-0.517|0.74
72466480|NCT02024750|144456346|OTHER||Mean Difference (Net)|-0.037||||0.79|TWO_SIDED|95.0|-0.312|0.237||The a priori threshold for statistical significance was p\<0.05|Mixed Models Analysis|Adjustments were made for study stratification variables and covariates that were imbalanced between study arms at baseline.|Positive values indicate a clinical benefit.|During the intervention period, the treatment effect on parent quality of life. Results reflect the difference in QOL trend between usual care and intervention arms.||0.237|-0.312|0.79
72466481|NCT02024750|144456346|OTHER||Mean Difference (Net)|-0.009||||0.97|TWO_SIDED|95.0|-0.467|0.448||The a priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|Adjustments were made for study stratification variables and covariates that were imbalanced between study arms at baseline.|Positive values indicate a clinical benefit.|During the post-intervention period, the treatment effect on parent quality of life. Results reflect the difference in QOL trend between usual care and intervention arms.||0.448|-0.467|0.97
72466482|NCT02024750|144456347|OTHER||Mean Difference (Net)|0.134||||0.3|TWO_SIDED|95.0|-0.121|0.388||The a priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|Adjustments were made for study stratification variables and covariates that were imbalanced between study arms at baseline.|Positive values indicate a clinical benefit.|During the intervention period, the treatment effect on parent fear of hypoglycemia. Results reflect the difference in FOH trend between usual care and intervention arms.||0.388|-0.121|0.30
72503449|NCT01165229|144537655|OTHER|The VE of HZ/su against duration of severe worst pain in subjects with confirmed HZ was demonstrated if the LL of the two-sided 95% CI of VE derived from the Hazard ratio was above 0%.|Vaccine efficacy|23.75||||0.2885|TWO_SIDED|95.0|-25.8|53.78|||Poisson exact test|||Comparison of VE in reduction of duration of severe worst HZ associated pain between Zoster-022/006 pooled GSK1437173A 70-79YOA Group and Zoster-022/006 pooled Placebo 70-79YOA Group||53.78|-25.80|0.2885
72503450|NCT01165229|144537655|OTHER|The VE of HZ/su against duration of severe worst pain in subjects with confirmed HZ was demonstrated if the LL of the two-sided 95% CI of VE derived from the Hazard ratio was above 0%.|Vaccine efficacy|54.93||||0.194|TWO_SIDED|95.0|-50.03|86.46|||Poisson exact test|||Comparison of VE in reduction of duration of severe worst HZ associated pain between Zoster-022/006 pooled GSK1437173A \>=80 YOA Group and Zoster-022/006 pooled Placebo \>=80 YOA Group||86.46|-50.03|0.1940
72503451|NCT01165229|144537655|OTHER|The VE of HZ/su against duration of severe worst pain in subjects with confirmed HZ was demonstrated if the LL of the two-sided 95% CI of VE derived from the Hazard ratio was above 0%.|Vaccine efficacy|30.48||||0.1243|TWO_SIDED|95.0|-10.52|56.27|||Poisson exact test|||Comparison of VE in reduction of duration of severe worst HZ associated pain between Zoster-022/006 pooled GSK1437173A \>=70 YOA Group and Zoster-022/006 pooled Placebo\>=70 YOA Group||56.27|-10.52|0.1243
72503452|NCT00780403|144537681|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0||||Statistical tests were performed at the significance level of 5%, without multiplicity adjustment.|Mainland-Gart Test|The p-value was derived from Mainland-Gart Test applied to a 2 (treatment sequence) by 2 (preferred period) contingency table.||The Mainland-Gart test was applied to the preference rates in the subjects who showed a preference, to assess the difference in preference rates between RediTab and Zyrtec.||||<0.0001
72503453|NCT04322708|144537682|SUPERIORITY||Percent Difference from Placebo|81.6|||<|0.0001|TWO_SIDED|95.0|71.5|89.0|||Fisher Exact|||||89.0|71.5|<0.0001
72503454|NCT04322708|144537682|SUPERIORITY||Percent Difference from Placebo|77.0|||<|0.0001|TWO_SIDED|95.0|66.1|85.4|||Fisher Exact|||||85.4|66.1|<0.0001
72503455|NCT04322708|144537683|SUPERIORITY||LSM Difference from Placebo|2.7||||0.247|TWO_SIDED|95.0|-1.9|7.3|||ANCOVA|||||7.3|-1.9|0.2470
72503456|NCT04322708|144537683|SUPERIORITY||LSM Difference from Placebo|-2.8||||0.2372|TWO_SIDED|95.0|-7.3|1.8|||ANCOVA|||||1.8|-7.3|0.2372
72503457|NCT04322708|144537684|SUPERIORITY||LSM Difference from Placebo|-95.7|||<|0.0001|TWO_SIDED|95.0|-109.0|-82.4|||ANCOVA|||||-82.4|-109|<0.0001
72503458|NCT04322708|144537684|SUPERIORITY||LSM Difference from Placebo|-96.2|||<|0.0001|TWO_SIDED|95.0|-110.0|-82.5|||ANCOVA|||||-82.5|-110|<0.0001
72503459|NCT04322708|144537685|SUPERIORITY||Percent Difference from Placebo|83.8|||<|0.0001|TWO_SIDED|95.0|74.4|90.8|||Fisher Exact|||||90.8|74.4|<0.0001
72466483|NCT02024750|144456347|OTHER||Mean Difference (Net)|-0.006||||0.98|TWO_SIDED|95.0|-0.384|0.373||The a priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|Adjustments were made for study stratification variables and covariates that were imbalanced between study arms at baseline.|Positive values indicate a clinical benefit.|During the post-intervention period, the treatment effect on parent fear of hypoglycemia. Results reflect the difference in FOH trend between usual care and intervention arms.||0.373|-0.384|0.98
72503460|NCT04322708|144537685|SUPERIORITY||Percent Difference from Placebo|80.3|||<|0.0001|TWO_SIDED|95.0|69.8|87.9|||Fisher Exact|||||87.9|69.8|<0.0001
72503461|NCT04322708|144537686|SUPERIORITY||Percent Difference from Placebo|77.3|||<|0.0001|TWO_SIDED|95.0|66.4|85.5|||Fisher Exact|||||85.5|66.4|<0.0001
72503462|NCT04322708|144537686|SUPERIORITY||Percent Difference from Placebo|72.7|||<|0.0001|TWO_SIDED|95.0|61.3|81.9|||Fisher Exact|||||81.9|61.3|<0.0001
72503463|NCT04322708|144537687|SUPERIORITY||Percent Difference from Placebo|36.5|||<|0.0001|TWO_SIDED|95.0|22.9|49.5|||Fisher Exact|||||49.5|22.9|<0.0001
72503464|NCT04322708|144537687|SUPERIORITY||Percent Difference from Placebo|49.5|||<|0.0001|TWO_SIDED|95.0|35.9|61.0|||Fisher Exact|||||61.0|35.9|<0.0001
72503465|NCT04322708|144537688|SUPERIORITY||Percent Difference from Placebo|-4.8||||0.5561|TWO_SIDED|95.0|-19.2|10.0|||Fisher Exact|||||10.0|-19.2|0.5561
72503466|NCT04322708|144537688|SUPERIORITY||Percent Difference from Placebo|4.9||||0.5554|TWO_SIDED|95.0|-9.9|19.6|||Fisher Exact|||||19.6|-9.9|0.5554
72503467|NCT04322708|144537689|SUPERIORITY||LSM Difference from Placebo|-0.6||||0.9506|TWO_SIDED|95.0|-18.1|17.0|||ANCOVA|||||17.0|-18.1|0.9506
72503468|NCT04322708|144537689|SUPERIORITY||LSM Difference from Placebo|-17.6||||0.0511|TWO_SIDED|95.0|-35.4|0.1|||ANCOVA|||||0.1|-35.4|0.0511
72564614|NCT02631837|144660798|SUPERIORITY||Risk Difference (RD)|-0.34||||0.007|TWO_SIDED|95.0|-0.56|-0.13|||Fisher Exact|||||-0.13|-0.56|0.007
72466484|NCT00702546|144456348|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|-9.4|||||TWO_SIDED|95.0|-19.5|0.7||||||Treatment groups were compared with a generalized linear model for the cumulative ongoing pregnancy rate including covariates treatment group, age class (\< 32 yrs vs. ≥ 32 yrs), planned IVF treatment (IVF vs. ICSI) and region (Europe vs. Asia).||0.7|-19.5|
72466485|NCT00092521|144456379|SUPERIORITY_OR_OTHER||Percent relative risk reduction|100.0||||||95.0|95.1|100.0|||||Confidence Interval (CI) based on binomial tail probabilities and not from a dispersion parameter|||100|95.1|
72466486|NCT00092521|144456380|SUPERIORITY_OR_OTHER||Percent relative risk reduction|100.0||||||95.0|94.9|100.0|||||CI based on binomial tail probabilities and not from a dispersion parameter|||100|94.9|
72466487|NCT02161406|144456391|SUPERIORITY|||||||0.28|||||||Mixed Models Analysis|||||||0.28
72466488|NCT02161406|144456392|SUPERIORITY|||||||0.73|||||||Mixed Models Analysis|||||||0.73
72466489|NCT02161406|144456393|SUPERIORITY|||||||0.03|||||||Mixed Models Analysis|||||||0.03
72466490|NCT02161406|144456394|SUPERIORITY|||||||0.11|||||||Mixed Models Analysis|||||||0.11
72503469|NCT04322708|144537690|SUPERIORITY||LSM Difference from Placebo|2.6||||0.2007|TWO_SIDED|95.0|-1.4|6.7|||Mixed Models Analysis|||Weeks 23-24 Change from Baseline||6.7|-1.4|0.2007
72503470|NCT04322708|144537690|SUPERIORITY||LSM Difference from Placebo|-2.7||||0.1889|TWO_SIDED|95.0|-6.8|1.3|||Mixed Models Analysis|||Weeks 23-24 Change from Baseline||1.3|-6.8|0.1889
72503471|NCT04322708|144537691|SUPERIORITY||LSM Difference from Placebo|-0.3||||0.498|TWO_SIDED|95.0|-1.3|0.6|||ANCOVA|||||0.6|-1.3|0.4980
72564615|NCT02631837|144660798|SUPERIORITY|||||||0.007|||||||Fisher Exact|||||||0.007
72564616|NCT02631837|144660800|SUPERIORITY||Mean Difference (Final Values)|-5.9||||0.006|TWO_SIDED|95.0|-10.0|-1.8|||Mann-Whitney U test|Two-sided test||||-1.8|-10|0.006
72466491|NCT02161406|144456395|SUPERIORITY|||||||0.19|||||||Mixed Models Analysis|||||||0.19
72466492|NCT02161406|144456396|SUPERIORITY|||||||0.005|||||||Mixed Models Analysis|||||||0.005
72466493|NCT02161406|144456397|SUPERIORITY|||||||0.19|||||||Mixed Models Analysis|||||||0.19
72466494|NCT02161406|144456398|SUPERIORITY|||||||0.34|||||||Mixed Models Analysis|||||||0.34
72466495|NCT02161406|144456399|SUPERIORITY|||||||0.25|||||||Mixed Models Analysis|||||||0.25
72466496|NCT02161406|144456400|SUPERIORITY|||||||0.12|||||||Mixed Models Analysis|||||||0.12
72466497|NCT02161406|144456401|SUPERIORITY|||||||0.82|||||||Mixed Models Analysis|||||||0.82
72466498|NCT02161406|144456402|SUPERIORITY|||||||0.37|||||||Mixed Models Analysis|||||||0.37
72466499|NCT02161406|144456403|SUPERIORITY|||||||0.55|||||||Mixed Models Analysis|||||||0.55
72466500|NCT02161406|144456404|SUPERIORITY|||||||0.15|||||||Mixed Models Analysis|||||||0.15
72466501|NCT02161406|144456405|SUPERIORITY|||||||0.21|||||||Mixed Models Analysis|||||||0.21
72466502|NCT02161406|144456406|SUPERIORITY|||||||0.81|||||||Mixed Models Analysis|||||||0.81
72466503|NCT02161406|144456407|SUPERIORITY|||||||0.86|||||||Mixed Models Analysis|||||||0.86
72466504|NCT02161406|144456408|SUPERIORITY|||||||0.91|||||||Mixed Models Analysis|||||||0.91
72466505|NCT02161406|144456409|SUPERIORITY|||||||0.13|||||||Mixed Models Analysis|||||||0.13
72466506|NCT02161406|144456410|SUPERIORITY|||||||0.92|||||||Mixed Models Analysis|||||||0.92
72466507|NCT02161406|144456411|SUPERIORITY|||||||0.24|||||||Mixed Models Analysis|||||||0.24
72466508|NCT02161406|144456412|SUPERIORITY|||||||0.07|||||||Mixed Models Analysis|||||||0.07
72466509|NCT02161406|144456413|SUPERIORITY|||||||0.03|||||||van Elteren test|The van Elteren test adjusted for duration of dcSSc. Multiple imputation was used to address missing follow-up data in 5 components of CRISS.||||||0.03
72466510|NCT02161406|144456414|SUPERIORITY|||||||0.1769|||||||Mixed Models Analysis|||||||0.1769
72466511|NCT02161406|144456415|SUPERIORITY|||||||0.9075|||||||Mixed Models Analysis|||||||0.9075
72466512|NCT02161406|144456416|SUPERIORITY|||||||0.5831|||||||Mixed Models Analysis|||||||0.5831
72466513|NCT02161406|144456417|SUPERIORITY|||||||0.0193|||||||Mixed Models Analysis|||||||0.0193
72466514|NCT02161406|144456418|SUPERIORITY|||||||0.0097|||||||Mixed Models Analysis|||||||0.0097
72466515|NCT02161406|144456419|SUPERIORITY|||||||0.0751|||||||Mixed Models Analysis|||||||0.0751
72466516|NCT02161406|144456420|SUPERIORITY|||||||0.4927|||||||Mixed Models Analysis|||||||0.4927
72466517|NCT02161406|144456421|SUPERIORITY|||||||0.1604|||||||Mixed Models Analysis|||||||0.1604
72466518|NCT02161406|144456422|SUPERIORITY|||||||0.7281|||||||Mixed Models Analysis|||||||0.7281
72466519|NCT02161406|144456423|SUPERIORITY|||||||0.1679|||||||Mixed Models Analysis|||||||0.1679
72466520|NCT02161406|144456424|SUPERIORITY|||||||0.2906|||||||Mixed Models Analysis|||||||0.2906
72466521|NCT01343251|144456443|SUPERIORITY_OR_OTHER|||||||0.48|TWO_SIDED||||||Chi-squared|||||||0.48
72466522|NCT01343251|144456444|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED||||||Chi-squared|||||||0.02
72503472|NCT04322708|144537691|SUPERIORITY||LSM Difference from Placebo|0.2||||0.639|TWO_SIDED|95.0|-0.7|1.2|||ANCOVA|||||1.2|-0.7|0.6390
72503473|NCT03240081|144537721|NON_INFERIORITY|We set 2 points (20%) as the margin of difference when defining and evaluating non-inferiority in comparing the 2 arms at 4 weeks.|Median Difference (Final Values)|2.0||||0.08|TWO_SIDED|||||Threshold for significance \< 0.05|Wilcoxon (Mann-Whitney)|||||||0.08
72503474|NCT03240081|144537722|NON_INFERIORITY|We set 2 points (20%) as the margin of difference when evaluating non-inferiority in comparing the 2 arms at 4 weeks.|Median Difference (Final Values)|2.0||||0.95|ONE_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.95
72564617|NCT02631837|144660801|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.00
72564618|NCT02631837|144660802|SUPERIORITY||||||>|0.05|||||||Fisher Exact|||||||> 0.05
72564619|NCT02631837|144660803|SUPERIORITY||Risk Difference (RD)|-0.29||||0.009|TWO_SIDED|95.0|-0.47|-0.1|||Fisher Exact|||||-0.10|-0.47|0.009
72564620|NCT02631837|144660804|SUPERIORITY|||||||0.106|||||||Fisher Exact|||||||0.106
72564621|NCT02631837|144660805|SUPERIORITY||Median Difference (Final Values)|-34.0|||<|0.01|TWO_SIDED|95.0|-46.0|-22.0|||Mann-Whitney U test|||||-22|-46|< 0.01
72564622|NCT02631837|144660806|SUPERIORITY|||||||0.7604||||||We tested a treatment arm by time interaction to study changes in differences for the outcomes during the follow-up period. In absence of such an interaction (p\>0.05 for the interaction term), the main effect of treatment was tested.|Arm by time interaction|||||||0.7604
72503475|NCT01480180|144537759|OTHER||Poisson estimate|3.7|||<|0.001|TWO_SIDED|95.0|2.94|4.66||P-values are from the 1-sided test of the null hypothesis that the ABR is at least 8.5 evaluated at the 2.5% level.|Poisson regression|||The analysis is based on a Poisson regression model allowing for over-dispersion. For participants withdrawing prematurely, the log planned treatment duration is used as offset; for completers, the log actual treatment duration is used.||4.66|2.94|<0.001
72503476|NCT01480180|144537761|OTHER||Poisson estimate|3.27|||<|0.001|TWO_SIDED|95.0|2.59|4.11||P-values are from the 1-sided test of the null hypothesis that the ABR is at least 8.5 evaluated at the 2.5% level.|Poisson regression|||The analysis is based on a Poisson regression model allowing for over-dispersion. For participants withdrawing prematurely, the log planned treatment duration is used as offset; for completers, the log actual treatment duration is used.||4.11|2.59|<0.001
72503477|NCT01480180|144537763|OTHER||Poisson estimate|2.35|||<|0.001|TWO_SIDED|95.0|1.87|2.95||P-values are from the 1-sided test of the null hypothesis that the ABR is at least 8.5 evaluated at the 2.5% level.|Poisson regression|||The analysis is based on a Poisson regression model allowing for over-dispersion. For participants withdrawing prematurely, the log planned treatment duration is used as offset; for completers, the log actual treatment duration is used.||2.95|1.87|<0.001
72466523|NCT01343251|144456445|SUPERIORITY_OR_OTHER|||||||0.49|TWO_SIDED|||||SF-36 Test 1 Total Score|t-test, 2 sided|||||||0.49
72466524|NCT01343251|144456445|SUPERIORITY_OR_OTHER|||||||0.91|TWO_SIDED|||||SF-36 Test 2 Total Score|t-test, 2 sided|||||||0.91
72466525|NCT01343251|144456445|SUPERIORITY_OR_OTHER|||||||0.67|TWO_SIDED|||||SF-36 Test 3 Total Score|t-test, 2 sided|||||||0.67
72466526|NCT01343251|144456445|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||SF-36 Test 4 Total Score|t-test, 2 sided|||||||<0.001
72466527|NCT01343251|144456446|SUPERIORITY_OR_OTHER|||||||0.04|TWO_SIDED||||||Chi-squared|||||||0.04
72466528|NCT01343251|144456447|SUPERIORITY_OR_OTHER|||||||0.9|TWO_SIDED||||||Chi-squared|||||||0.90
72503478|NCT01480180|144537763|OTHER||Poisson estimate|4.39|||<|0.001|TWO_SIDED|95.0|3.09|6.24||P-values are from the 1-sided test of the null hypothesis that the ABR is at least 8.5 evaluated at the 2.5% level.|Poisson regression|||The analysis is based on a Poisson regression model allowing for over-dispersion. For participants withdrawing prematurely, the log planned treatment duration is used as offset; for completers, the log actual treatment duration is used.||6.24|3.09|<0.001
72503479|NCT03429075|144537851|EQUIVALENCE|ANCOVA||||||0.17|||||||ANCOVA|||||||0.17
72564623|NCT02631837|144660807|SUPERIORITY|||||||0.3071||||||We tested a treatment arm by time interaction to study changes in differences for the outcomes during the follow-up period. In absence of such an interaction (p\>0.05 for the interaction term), the main effect of treatment was tested.|Arm by time interaction|||||||0.3071
72564624|NCT02631837|144660808|SUPERIORITY|||||||0.4541||||||We tested a treatment arm by time interaction to study changes in differences for the outcomes during the follow-up period. In absence of such an interaction (p\>0.05 for the interaction term), the main effect of treatment was tested.|Arm by time interaction|||||||0.4541
72564625|NCT02631837|144660809|SUPERIORITY|||||||0.4514||||||We tested a treatment arm by time interaction to study changes in differences for the outcomes during the follow-up period. In absence of such an interaction (p\>0.05 for the interaction term), the main effect of treatment was tested.|Arm by time interaction|||||||0.4514
72466529|NCT00362375|144456448|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.4|||<|0.05|TWO_SIDED|95.0|1.28|4.5|||Generalized Estimating Equation|||GEE cluster-adjusted odds ratio||4.50|1.28|<0.05
72466530|NCT00362375|144456449|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.48|||<|0.05|TWO_SIDED|95.0|0.2|1.16|||GEE|||||1.16|0.20|<0.05
72466531|NCT00362375|144456450|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.39|||<|0.05|TWO_SIDED|95.0|0.99|1.95|||GEE|||||1.95|0.99|<0.05
72466532|NCT00362375|144456451|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.07|||<|0.05|TWO_SIDED|95.0|0.8|1.44|||GEE|GEE incident rate ratio||||1.44|0.80|<0.05
72466533|NCT00362375|144456452|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.44|||<|0.05|TWO_SIDED|95.0|0.76|2.71|||GEE|||||2.71|0.76|<0.05
72466534|NCT01983553|144456506|OTHER|Relative risk analysis of the event rate per 100 participants during Year 1 to Year 4 for Any of the 4 Serotypes between the CYD Dengue vaccine group and the Control group.|Relative Risk|0.93|||||TWO_SIDED|95.0|0.64|1.36|||||The 95% confidence interval of the relative risk was calculated using the Exact method described by Breslow and Day.|Relative risk; Any of the 4 Serotypes||1.36|0.64|
72466535|NCT01983553|144456506|OTHER|Relative risk analysis of the event rate per 100 participants during Year 1 to Year 4 for Serotype 1 between the CYD Dengue vaccine group and the Control group.|Relative Risk|0.96|||||TWO_SIDED|95.0|0.44|2.21|||||The 95% confidence interval of the relative risk was calculated using the Exact method described by Breslow and Day.|Relative risk; Serotype 1||2.21|0.44|
72466536|NCT01983553|144456506|OTHER|Relative risk analysis of the event rate per 100 participants during Year 1 to Year 4 for Serotype 2 between the CYD Dengue vaccine group and the Control group.|Relative Risk|1.326|||||TWO_SIDED|95.0|0.64|2.94|||||The 95% confidence interval of the relative risk was calculated using the Exact method described by Breslow and Day.|Relative risk; Serotype 2||2.94|0.64|
72466537|NCT01983553|144456506|OTHER|Relative risk analysis of the event rate per 100 participants during Year 1 to Year 4 for Serotype 3 between the CYD Dengue vaccine group and the Control group.|Relative Risk|1.056|||||TWO_SIDED|95.0|0.48|2.51|||||The 95% confidence interval of the relative risk was calculated using the Exact method described by Breslow and Day.|Relative risk; Serotype 3||2.51|0.48|
72466538|NCT01983553|144456506|OTHER|Relative risk analysis of the event rate per 100 participants during Year 1 to Year 4 for Serotype 4 between the CYD Dengue vaccine group and the Control group.|Relative Risk|0.629|||||TWO_SIDED|95.0|0.27|1.47|||||The 95% confidence interval of the relative risk was calculated using the Exact method described by Breslow and Day.|Relative risk; Serotype 4||1.47|0.27|
72466539|NCT01983553|144456506|OTHER|Relative risk analysis of the event rate per 100 participants during Year 1 to Year 4 for Unserotyped between the CYD Dengue vaccine group and the Control group.|Relative Risk|0.0|||||TWO_SIDED|95.0|0.0|1.22|||||The 95% confidence interval of the relative risk was calculated using the Exact method described by Breslow and Day.|Relative risk; Unserotyped||1.22|0.00|
72503480|NCT01476787|144537916|SUPERIORITY|||||||0.128|||||||Cochran-Mantel-Haenszel|||||||0.128
72564626|NCT02631837|144660810|SUPERIORITY|||||||0.3473||||||We tested a treatment arm by time interaction to study changes in differences for the outcomes during the follow-up period. In absence of such an interaction (p\>0.05 for the interaction term), the main effect of treatment was tested.|Arm by time interaction|||||||0.3473
72466540|NCT01983553|144456509|OTHER|Relative risk analysis of the event rate per 100 participants during Year 1 to Year 4 for Any of the 4 Serotypes (4 to 5 years) between the CYD Dengue vaccine group and the Control group. Total number of participants analyzed were 585 instead of 3203.|Relative Risk|1.411|||||TWO_SIDED|95.0|0.64|3.42|||||The 95% confidence interval of the relative risk was calculated using the Exact method described by Breslow and Day.|Relative Risk; 4 to 5 years; Any Serotype||3.42|0.64|
72466541|NCT01983553|144456509|OTHER|Relative risk analysis of the event rate per 100 participants during Year 1 to Year 4 for Any of the 4 Serotypes (6 to 11 years) between the CYD Dengue vaccine group and the Control group. Total number of participants analyzed were 2618 instead of 3203.|Relative Risk|0.807|||||TWO_SIDED|95.0|0.53|1.25|||||The 95% confidence interval of the relative risk was calculated using the Exact method described by Breslow and Day.|Relative Risk; 6 to 11 years; Any Serotype||1.25|0.53|
72466542|NCT01983553|144456509|OTHER|Relative risk analysis of the event rate per 100 participants during Year 1 to Year 4 for Serotype 1 (4 to 5 years) between the CYD Dengue vaccine group and the Control group. Total number of participants analyzed were 585 instead of 3203.|Relative Risk|4.885|||||TWO_SIDED|95.0|0.7|212.02|||||The 95% confidence interval of the relative risk was calculated using the Exact method described by Breslow and Day.|Relative Risk; 4 to 5 years; Serotype 1||212.02|0.70|
72466543|NCT01983553|144456509|OTHER|Relative risk analysis of the event rate per 100 participants during Year 1 to Year 4 for Serotype 1 (6 to 11 years) between the CYD Dengue vaccine group and the Control group. Total number of participants analyzed were 2618 instead of 3203.|Relative Risk|0.557|||||TWO_SIDED|95.0|0.21|1.46|||||The 95% confidence interval of the relative risk was calculated using the Exact method described by Breslow and Day.|Relative Risk; 6 to 11 years; Serotype 1||1.46|0.21|
72466544|NCT01983553|144456509|OTHER|Relative risk analysis of the event rate per 100 participants during Year 1 to Year 4 for Serotype 2 (4 to 5 years) between the CYD Dengue vaccine group and the Control group. Total number of participants analyzed were 585 instead of 3203.|Relative Risk|2.931|||||TWO_SIDED|95.0|0.36|134.83|||||The 95% confidence interval of the relative risk was calculated using the Exact method described by Breslow and Day.|Relative Risk; 4 to 5 years; Serotype 2||134.83|0.36|
72466545|NCT01983553|144456509|OTHER|Relative risk analysis of the event rate per 100 participants during Year 1 to Year 4 for Serotype 2 (6 to 11 years) between the CYD Dengue vaccine group and the Control group. Total number of participants analyzed were 2618 instead of 3203.|Relative Risk|1.165|||||TWO_SIDED|95.0|0.53|2.74|||||The 95% confidence interval of the relative risk was calculated using the Exact method described by Breslow and Day.|Relative Risk; 6 to 11 years; Serotype 2||2.74|0.53|
72466546|NCT01983553|144456509|OTHER|Relative risk analysis of the event rate per 100 participants at Year 1 for Serotype 3 (4 to 5 year) between the CYD Dengue vaccine group and the Control group. Total number of participants analyzed were 585 instead of 3203.|Relative Risk|1.221|||||TWO_SIDED|95.0|0.2|12.83|||||The 95% confidence interval of the relative risk was calculated using the Exact method described by Breslow and Day.|Relative Risk; 4 to 5 years; Serotype 3||12.83|0.20|
72466547|NCT01983553|144456509|OTHER|Relative risk analysis of the event rate per 100 participants during Year 1 to Year 4 for Serotype 3 (6 to 11 years) between the CYD Dengue vaccine group and the Control group. Total number of participants analyzed were 2618 instead of 3203.|Relative Risk|1.013|||||TWO_SIDED|95.0|0.41|2.73|||||The 95% confidence interval of the relative risk was calculated using the Exact method described by Breslow and Day.|Relative Risk; 6 to 11 years; Serotype 3||2.73|0.41|
72466548|NCT01983553|144456509|OTHER|Relative risk analysis of the event rate per 100 participants during Year 1 to Year 4 for Serotype 4 (4 to 5 years) between the CYD Dengue vaccine group and the Control group. Total number of participants analyzed were 585 instead of 3203.|Relative Risk|0.977|||||TWO_SIDED|95.0|0.21|6.04|||||The 95% confidence interval of the relative risk was calculated using the Exact method described by Breslow and Day.|Relative Risk; 4 to 5 years; Serotype 4||6.04|0.21|
72466549|NCT01983553|144456509|OTHER|Relative risk analysis of the event rate per 100 participants during Year 1 to Year 4 for Serotype 4 (6 to 11 years) between the CYD Dengue vaccine group and the Control group. Total number of participants analyzed were 2618 instead of 3203.|Relative Risk|0.506|||||TWO_SIDED|95.0|0.18|1.44|||||The 95% confidence interval of the relative risk was calculated using the Exact method described by Breslow and Day.|Relative Risk; 6 to 11 years; Serotype 4||1.44|0.18|
72466550|NCT01983553|144456509|OTHER|Relative risk analysis of the event rate per 100 participants during Year 1 to Year 4 for Unserotyped (4 to 5 years) between the CYD Dengue vaccine group and the Control group. Total number of participants analyzed were 585 instead of 3203.|Relative Risk|0.0|||||TWO_SIDED|95.0|0.0|2.6|||||The 95% confidence interval of the relative risk was calculated using the Exact method described by Breslow and Day.|Relative Risk; 4 to 5 years; Unserotyped||2.60|0.00|
72466551|NCT01983553|144456509|OTHER|Relative risk analysis of the event rate per 100 participants during Year 1 to Year 4 for Unserotyped (6 to 11 years) between the CYD Dengue vaccine group and the Control group. Total number of participants analyzed were 2618 instead of 3203.|Relative Risk|0.0|||||TWO_SIDED|95.0|0.0|19.75|||||The 95% confidence interval of the relative risk was calculated using the Exact method described by Breslow and Day.|Relative Risk; 6 to 11 years; Unserotyped||19.75|0.00|
72466552|NCT01983553|144456517|OTHER|Relative risk analysis of the event rate per 100 participants during Year 1 to Year 4 for Any of the 4 Serotypes; Any grade between the CYD Dengue vaccine group and the Control group.|Relative Risk|1.174|||||TWO_SIDED|95.0|0.27|7.03|||||The 95% confidence interval of the relative risk was calculated using the Exact method described by Breslow and Day.|Relative Risk; Any serotype; Any grade||7.03|0.27|
72466553|NCT01983553|144456517|OTHER|Relative risk analysis of the event rate per 100 participants during Year 1 to Year 4 for Any of the 4 Serotypes; Grade I between the CYD Dengue vaccine group and the Control group.|Relative Risk|0.252|||||TWO_SIDED|95.0|0.0|4.83|||||The 95% confidence interval of the relative risk was calculated using the Exact method described by Breslow and Day.|Relative Risk; Any serotype; Grade I||4.83|0.00|
72503481|NCT01476787|144537917|SUPERIORITY||Hazard Ratio (HR)|0.92||||0.406|TWO_SIDED|95.0|0.756|1.12|||Log Rank|||||1.120|0.756|0.406
72503482|NCT01476787|144537919|SUPERIORITY||Hazard Ratio (HR)|1.038|||||TWO_SIDED|95.0|0.854|1.261||||||||1.261|0.854|
72503483|NCT01476787|144537920|SUPERIORITY||Hazard Ratio (HR)|1.04|||||TWO_SIDED|95.0|0.775|1.395||||||||1.395|0.775|
72503484|NCT01476787|144537921|SUPERIORITY||Hazard Ratio (HR)|0.809|||||TWO_SIDED|95.0|0.651|1.006|||Regression, Cox|||||1.006|0.651|
72466554|NCT01983553|144456517|OTHER|Relative risk analysis of the event rate per 100 participants during Year 1 to Year 4 for Any of the 4 Serotypes Grade II between the CYD Dengue vaccine group and the Control group.|Relative Risk|2.012|||||TWO_SIDED|95.0|0.2|99.1|||||The 95% confidence interval of the relative risk was calculated using the Exact method described by Breslow and Day.|Relative Risk; Any serotype; Grade II||99.10|0.20|
72466555|NCT01983553|144456517|OTHER|Relative risk analysis of the event rate per 100 participants during Year 1 to Year 4 for Serotype 2 Any grade between the CYD Dengue vaccine group and the Control group.|Relative Risk|0.503|||||TWO_SIDED|95.0|0.01|39.49|||||The 95% confidence interval of the relative risk was calculated using the Exact method described by Breslow and Day.|Relative Risk; Serotype 2; Any grade||39.49|0.01|
72466556|NCT01983553|144456517|OTHER|Relative risk analysis of the event rate per 100 participants during Year 1 to Year 4 for Serotype 2 Grade I between the CYD Dengue vaccine group and the Control group.|Relative Risk|0.503|||||TWO_SIDED|95.0|0.01|39.49|||||The 95% confidence interval of the relative risk was calculated using the Exact method described by Breslow and Day.|Relative Risk; Serotype 2; Grade I||39.49|0.01|
72466557|NCT01983553|144456517|OTHER|Relative risk analysis of the event rate per 100 participants during Year 1 to Year 4 for Serotype 4 Any grade between the CYD Dengue vaccine group and the Control group.|Relative Risk|0.252|||||TWO_SIDED|95.0|0.0|4.83|||||The 95% confidence interval of the relative risk was calculated using the Exact method described by Breslow and Day.|Relative Risk; Serotype 4; Any grade||4.83|0.00|
72466558|NCT01983553|144456517|OTHER|Relative risk analysis of the event rate per 100 participants during Year 1 to Year 4 for Serotype 4 Grade I between the CYD Dengue vaccine group and the Control group.|Relative Risk|0.0|||||TWO_SIDED|95.0|0.0|19.62|||||The 95% confidence interval of the relative risk was calculated using the Exact method described by Breslow and Day.|Relative Risk; Serotype 4; Grade I||19.62|0.00|
72466559|NCT01983553|144456517|OTHER|Relative risk analysis of the event rate per 100 participants during Year 1 to Year 4 for Serotype 4 Grade II between the CYD Dengue vaccine group and the Control group.|Relative Risk|0.503|||||TWO_SIDED|95.0|0.01|39.49|||||The 95% confidence interval of the relative risk was calculated using the Exact method described by Breslow and Day.|Relative Risk; Serotype 4; Grade II||39.49|0.01|
72466560|NCT00469456|144456527|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.3||||0.07||95.0|-0.1|2.8|||ANCOVA|||The primary efficacy parameter was change from Baseline to Week 12 in FLCI total score. Missing FLCI total scores at Week 12 were imputed using the last-observation-carried-forward (LOCF) approach.||2.8|-0.1|0.070
72466561|NCT00469456|144456528|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.9||||0.022||95.0|0.9|10.9|||ANCOVA|||The secondary efficacy parameter was change from Baseline at Week 12 in the total score of the Social Communication subscale and Communication of Basic Needs subscale of the ASHA FACS. Missing scores at week 12 were imputed using the last-observation-carried-forward (LOCF) approach.||10.9|0.9|0.022
72466562|NCT03634839|144456529|SUPERIORITY||Mean Difference (Final Values)|-5.184||||0.053|TWO_SIDED||||||t-test, 2 sided|||||||0.053
72503485|NCT01450137|144537922|SUPERIORITY||Risk Difference (RD)|0.45||||0.0301|TWO_SIDED|95.0|0.11|0.79|||Fisher Exact|||||0.79|0.11|0.0301
72370714|NCT00488683|144251643|SUPERIORITY_OR_OTHER||R-square|0.3||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between demographic factors, memory B cells one month after primary vaccination and rise in hSBA after booster vaccination age for the serogroup W-135||||
72466563|NCT03634839|144456530|SUPERIORITY||Mean Difference (Final Values)|-1.881||||0.187|TWO_SIDED||||||t-test, 2 sided|||Outcome analyses will be intent-to-treat and using mixed-effects models with flavor as a within-subject factor. A significant main effect of flavor with greater liking of sweet plus cooling flavor than sweet minus cooling flavor will be considered supportive of our hypotheses.||||0.187
72466564|NCT03634839|144456531|SUPERIORITY||Mean Difference (Final Values)|-0.286||||0.135|TWO_SIDED||||||t-test, 2 sided|||||||0.135
72466565|NCT03634839|144456532|SUPERIORITY||Mean Difference (Final Values)|1.942||||0.21|TWO_SIDED||||||t-test, 2 sided|||||||0.210
72466566|NCT04198948|144456533|EQUIVALENCE|Sample size calculation was performed using SAS Proc Power procedure for equivalence test in 2x2 crossover design. For an equivalence range of 80-125%, the within-subject coefficient of variation for the AUC values for gliclazide of 7.8% based on previous PK studies, and expected test/reference geometric mean ratios between 87-115%, 14 volunteers (7 individuals per sequence) are required to show the lack of interaction with 85% power.|Geometric least square mean ratio|1.13|||||TWO_SIDED|90.0|0.86|1.48|||||The TOST (two one-sided test) test of equivalence showed that the geometric mean ratio and 90% CI for gliclazide AUC(0-24) between omeprazole and placebo phase was 1.13 (0.86-1.48), with upper confidence limit above the usual 1.25 boundary.|The main evaluated outcome was systemic exposure to gliclazide, expressed as AUC(0-t). The geometric mean was calculated for gliclazide AUC(0-24). The ratio of the geometric means with 90% CIs was assessed by linear mixed models between the two treatment assignments: gliclazide and omeprazole co-administration to that of gliclazide and placebo. The obtained 90% CI was compared with the equivalence 0.8-1.25 range.||1.48|0.86|
72466567|NCT04198948|144456534|SUPERIORITY|||||||0.636|||||||t-test, 2 sided|||||||0.636
72466568|NCT04198948|144456535|SUPERIORITY|||||||0.055|||||||t-test, 2 sided|||||||0.055
72466569|NCT02447432|144456536|NON_INFERIORITY|GMCs ratio and its 95 % CI were obtained using an ANOVA model on the logarithm-10 transformed concentrations-pooled variance.|GMCs ratio|1.09|||||TWO_SIDED|95.0|0.89|1.33||||||(Synflorix/10Pn\_4d) antibody GMCs ratio for ANTI-1 serotype: to demonstrate non-inferiority of 10Pn-PD-DiT vaccine (4-dose presentation) as compared to 10Pn-PD-DiT vaccine (1-dose presentation) in terms of immune response, 1 month after dose 3. Criterion: the upper limit (UL) of the 2-sided 95% confidence interval (CI) of the geometric mean antibody concentration (GMC) ratios (Synflorix/10Pn\_4d) should be below a limit of 2-fold for each of the 10 serotypes.||1.33|0.89|
72503486|NCT01450137|144537923|SUPERIORITY||Risk Difference (RD)|0.65||||0.001|TWO_SIDED|95.0|0.36|0.94|||Fisher Exact|||||0.94|0.36|0.0010
72503487|NCT01450137|144537924|SUPERIORITY|||||||0.0005|||||||Wilcoxon (Mann-Whitney)|||||||0.0005
72503488|NCT01450137|144537925|SUPERIORITY||Mean Difference (Final Values)|25.0||||0.0005|TWO_SIDED|95.0|11.0|39.0|||z-test||Difference between restricted mean survival time at 12 months|||39|11|0.0005
72503489|NCT01662999|144537956|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric mean|0.943|||||TWO_SIDED|90.0|0.867|1.026|||Mixed Models Analysis|||The statistical model includes treatment and period as fixed effects and measurements within each participant as repeated measurements. The adjusted geometric means are from the mixed model.||1.026|0.867|
72466570|NCT02447432|144456536|NON_INFERIORITY|GMCs ratio and its 95 % CI were obtained using an ANOVA model on the logarithm-10 transformed concentrations-pooled variance.|GMCs ratio|0.92|||||TWO_SIDED|95.0|0.75|1.12||||||(Synflorix/10Pn\_4d) antibody GMCs ratio for ANTI-4 serotype: to demonstrate non-inferiority of 10Pn-PD-DiT vaccine (4-dose presentation) as compared to 10Pn-PD-DiT vaccine (1-dose presentation) in terms of immune response, 1 month after dose 3. Criterion: the upper limit (UL) of the 2-sided 95% confidence interval (CI) of the geometric mean antibody concentration (GMC) ratios (Synflorix/10Pn\_4d) should be below a limit of 2-fold for each of the 10 serotypes.||1.12|0.75|
72466571|NCT02447432|144456536|NON_INFERIORITY|GMCs ratio and its 95 % CI were obtained using an ANOVA model on the logarithm-10 transformed concentrations-pooled variance.|GMCs ratio|1.03|||||TWO_SIDED|95.0|0.85|1.26||||||(Synflorix/10Pn\_4d) antibody GMCs ratio for ANTI-5 serotype: to demonstrate non-inferiority of 10Pn-PD-DiT vaccine (4-dose presentation) as compared to 10Pn-PD-DiT vaccine (1-dose presentation) in terms of immune response, 1 month after dose 3. Criterion: the upper limit (UL) of the 2-sided 95% confidence interval (CI) of the geometric mean antibody concentration (GMC) ratios (Synflorix/10Pn\_4d) should be below a limit of 2-fold for each of the 10 serotypes.||1.26|0.85|
72466572|NCT02447432|144456536|NON_INFERIORITY|GMCs ratio and its 95 % CI were obtained using an ANOVA model on the logarithm-10 transformed concentrations-pooled variance.|GMCs ratio|1.12|||||TWO_SIDED|95.0|0.78|1.61||||||(Synflorix/10Pn\_4d) antibody GMCs ratio for ANTI-6B serotype: to demonstrate non-inferiority of 10Pn-PD-DiT vaccine (4-dose presentation) as compared to 10Pn-PD-DiT vaccine (1-dose presentation) in terms of immune response, 1 month after dose 3. Criterion: the upper limit (UL) of the 2-sided 95% confidence interval (CI) of the geometric mean antibody concentration (GMC) ratios (Synflorix/10Pn\_4d) should be below a limit of 2-fold for each of the 10 serotypes.||1.61|0.78|
72466573|NCT02447432|144456536|NON_INFERIORITY|GMCs ratio and its 95 % CI were obtained using an ANOVA model on the logarithm-10 transformed concentrations-pooled variance.|GMCs ratio|1.05|||||TWO_SIDED|95.0|0.88|1.25||||||(Synflorix/10Pn\_4d) antibody GMCs ratio for ANTI-7F serotype: to demonstrate non-inferiority of 10Pn-PD-DiT vaccine (4-dose presentation) as compared to 10Pn-PD-DiT vaccine (1-dose presentation) in terms of immune response, 1 month after dose 3. Criterion: the upper limit (UL) of the 2-sided 95% confidence interval (CI) of the geometric mean antibody concentration (GMC) ratios (Synflorix/10Pn\_4d) should be below a limit of 2-fold for each of the 10 serotypes.||1.25|0.88|
72466574|NCT02447432|144456536|NON_INFERIORITY|GMCs ratio and its 95 % CI were obtained using an ANOVA model on the logarithm-10 transformed concentrations-pooled variance.|GMCs ratio|0.88|||||TWO_SIDED|95.0|0.69|1.13||||||(Synflorix/10Pn\_4d) antibody GMCs ratio for ANTI-9V serotype: to demonstrate non-inferiority of 10Pn-PD-DiT vaccine (4-dose presentation) as compared to 10Pn-PD-DiT vaccine (1-dose presentation) in terms of immune response, 1 month after dose 3. Criterion: the upper limit (UL) of the 2-sided 95% confidence interval (CI) of the geometric mean antibody concentration (GMC) ratios (Synflorix/10Pn\_4d) should be below a limit of 2-fold for each of the 10 serotypes.||1.13|0.69|
72466575|NCT02447432|144456536|NON_INFERIORITY|GMCs ratio and its 95 % CI were obtained using an ANOVA model on the logarithm-10 transformed concentrations-pooled variance.|GMCs ratio|0.98|||||TWO_SIDED|95.0|0.73|1.31||||||(Synflorix/10Pn\_4d) antibody GMCs ratio for ANTI-14 serotype: to demonstrate non-inferiority of 10Pn-PD-DiT vaccine (4-dose presentation) as compared to 10Pn-PD-DiT vaccine (1-dose presentation) in terms of immune response, 1 month after dose 3. Criterion: the upper limit (UL) of the 2-sided 95% confidence interval (CI) of the geometric mean antibody concentration (GMC) ratios (Synflorix/10Pn\_4d) should be below a limit of 2-fold for each of the 10 serotypes.||1.31|0.73|
72466576|NCT02447432|144456536|NON_INFERIORITY|GMCs ratio and its 95 % CI were obtained using an ANOVA model on the logarithm-10 transformed concentrations-pooled variance.|GMCs ratio|1.08|||||TWO_SIDED|95.0|0.86|1.37||||||(Synflorix/10Pn\_4d) antibody GMCs ratio for ANTI-18C serotype: to demonstrate non-inferiority of 10Pn-PD-DiT vaccine (4-dose presentation) as compared to 10Pn-PD-DiT vaccine (1-dose presentation) in terms of immune response, 1 month after dose 3. Criterion: the upper limit (UL) of the 2-sided 95% confidence interval (CI) of the geometric mean antibody concentration (GMC) ratios (Synflorix/10Pn\_4d) should be below a limit of 2-fold for each of the 10 serotypes.||1.37|0.86|
72466577|NCT02447432|144456536|NON_INFERIORITY|GMCs ratio and its 95 % CI were obtained using an ANOVA model on the logarithm-10 transformed concentrations-pooled variance.|GMCs ratio|0.99|||||TWO_SIDED|95.0|0.78|1.25||||||(Synflorix/10Pn\_4d) antibody GMCs ratio for ANTI-19F serotype: to demonstrate non-inferiority of 10Pn-PD-DiT vaccine (4-dose presentation) as compared to 10Pn-PD-DiT vaccine (1-dose presentation) in terms of immune response, 1 month after dose 3. Criterion: the upper limit (UL) of the 2-sided 95% confidence interval (CI) of the geometric mean antibody concentration (GMC) ratios (Synflorix/10Pn\_4d) should be below a limit of 2-fold for each of the 10 serotypes.||1.25|0.78|
72466578|NCT02447432|144456536|NON_INFERIORITY|GMCs ratio and its 95 % CI were obtained using an ANOVA model on the logarithm-10 transformed concentrations-pooled variance.|GMCs ratio|1.28|||||TWO_SIDED|95.0|0.92|1.8||||||(Synflorix/10Pn\_4d) antibody GMCs ratio for ANTI-23F serotype: to demonstrate non-inferiority of 10Pn-PD-DiT vaccine (4-dose presentation) as compared to 10Pn-PD-DiT vaccine (1-dose presentation) in terms of immune response, 1 month after dose 3. Criterion: the upper limit (UL) of the 2-sided 95% confidence interval (CI) of the geometric mean antibody concentration (GMC) ratios (Synflorix/10Pn\_4d) should be below a limit of 2-fold for each of the 10 serotypes.||1.80|0.92|
72466579|NCT00913068|144456550|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0012||95.0|||||Chi-squared|||||||0.0012
72466580|NCT00726713|144456558|SUPERIORITY_OR_OTHER||||||=|0.013|||||||Mixed Models Analysis|Generalized linear mixed models were used to assess baseline for continuous and discrete outcomes||Change from Baseline, Week 16||||=0.013
72503490|NCT01662999|144537957|SUPERIORITY_OR_OTHER||Ration of adjusted geometric mean|0.984|||||TWO_SIDED|90.0|0.961|1.008|||Mixed Models Analysis|||Treatment B versus C in AUC(INF). The statistical model includes treatment and period as fixed effects and measurements within each participant as repeated measurements. The adjusted geometric means are from the mixed model.||1.008|0.961|
72621706|NCT03533491|144773641|EQUIVALENCE|A test of the null hypothesis that the pretest to posttest change is equal to zero.|Mean Difference (Final Values)|-0.158|STANDARD_ERROR_OF_MEAN|0.255||0.255|TWO_SIDED||||||t-test, 2 sided|A paired t-test that evaluates whether significant pretest to posttest change is different from zero.||||||.255
72503491|NCT01662999|144537959|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric mean|0.99|||||TWO_SIDED|90.0|0.966|1.014|||Mixed Models Analysis|||Treatment B versus C in AUC(0-T). The statistical model includes treatment and period as fixed effects and measurements within each participant as repeated measurements. The adjusted geometric means are from the mixed model.||1.014|0.966|
72466581|NCT00726713|144456558|SUPERIORITY_OR_OTHER||||||=|0.033|||||||Mixed Models Analysis|Generalized linear mixed models were used to assess baseline for continuous and discrete outcomes||Change from Baseline, Week 24||||=0.033
72466582|NCT00726713|144456559|SUPERIORITY_OR_OTHER||||||=|0.027|||||||Mixed Models Analysis|Generalized linear mixed models were used to assess baseline for continuous and discrete outcomes||Change from Baseline, Week 16||||=0.027
72466583|NCT00726713|144456560|SUPERIORITY_OR_OTHER||||||=|0.0001||||||Generalized linear mixed models were used to assess baseline for continuous and discrete outcomes|Mixed Models Analysis|||Total Folate, Change from BL, Week 16||||=0.0001
72466584|NCT00726713|144456560|SUPERIORITY_OR_OTHER||||||=|0.0001||||||Generalized linear mixed models were used to assess baseline for continuous and discrete outcomes|Mixed Models Analysis|||Total Folate, Change from BL, Week 24||||=0.0001
72466585|NCT00726713|144456560|SUPERIORITY_OR_OTHER||||||=|0.0001|||||||Mixed Models Analysis|Generalized linear mixed models were used to assess baseline for continuous and discrete outcomes||Total MMA, Change from Baseline Week 16||||=0.0001
72466586|NCT00726713|144456560|SUPERIORITY_OR_OTHER||||||=|0.0008|||||||Mixed Models Analysis|Generalized linear mixed models were used to assess baseline for continuous and discrete outcomes||Total MMA, Change from BL, Week 24||||=0.0008
72466587|NCT00726713|144456560|SUPERIORITY_OR_OTHER||||||=|0.0001||||||Generalized linear mixed models were used to assess baseline for continuous and discrete outcomes|Mixed Models Analysis|||Total Homocysteine, Change from BL, Week 16||||=0.0001
72466588|NCT00726713|144456560|SUPERIORITY_OR_OTHER||||||=|0.0001|||||||Mixed Models Analysis|Generalized linear mixed models were used to assess baseline for continuous and discrete outcomes||Total Homocysteine, Change from BL, Week 24||||=0.0001
72466589|NCT00726713|144456561|SUPERIORITY_OR_OTHER||||||=|0.0306||||||Generalized linear mixed models were used to assess baseline for continuous and discrete outcomes|Mixed Models Analysis|||SF-36 MCS, Change from BL, Week 24||||=0.0306
72466590|NCT00726713|144456564|SUPERIORITY_OR_OTHER||||||=|0.054|||||||Mixed Models Analysis|Generalized linear mixed models were used to assess baseline for continuous and discrete outcomes||HADS Depression, Change from BL, Week 24||||=0.054
72466591|NCT02367105|144456568|SUPERIORITY||Mean Difference (Final Values)|-0.3||||0.58|TWO_SIDED||||||Mixed Models Analysis|Baseline values as covariate||||||0.58
72621707|NCT03533491|144773642|EQUIVALENCE|A test of the null hypothesis that the pretest to posttest change is equal to zero.|Mean Difference (Final Values)|0.139|STANDARD_ERROR_OF_MEAN|0.142|||TWO_SIDED|||||||A paired t-test that evaluates whether significant pretest to posttest change is different from zero.||||||
72466592|NCT02367105|144456569|SUPERIORITY||Mean Difference (Final Values)|-1.2||||0.03|TWO_SIDED||||||Mixed Models Analysis|Baseline value adjusted||||||0.03
72466593|NCT02367105|144456570|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.97|TWO_SIDED||||||Mixed Models Analysis|Baseline value adjusted||||||.97
72466594|NCT02367105|144456571|SUPERIORITY||Mean Difference (Final Values)|-0.7||||0.56|TWO_SIDED||||||Mixed Models Analysis|Baseline value adjusted||||||0.56
72466595|NCT02367105|144456572|SUPERIORITY||Mean Difference (Final Values)|-1.2||||0.01|TWO_SIDED||||||Mixed Models Analysis|||||||0.01
72466596|NCT02367105|144456573|SUPERIORITY||Mean Difference (Final Values)|-1.1||||0.91|TWO_SIDED||||||Mixed Models Analysis|||||||0.91
72466597|NCT02367105|144456574|SUPERIORITY||Mean Difference (Final Values)|-42.0||||0.04|TWO_SIDED||||||Mixed Models Analysis|Baseline value adjusted||||||0.04
72466598|NCT02367105|144456575|SUPERIORITY||Mean Difference (Final Values)|-29.0||||0.67|TWO_SIDED||||||Mixed Models Analysis|Baseline values as covariates||||||.67
72466599|NCT02367105|144456576|SUPERIORITY||Mean Difference (Final Values)|-0.019||||0.003|TWO_SIDED||||||Mixed Models Analysis|Baseline valued adjusted||||||0.003
72466600|NCT02367105|144456577|SUPERIORITY||Mean Difference (Final Values)|-0.003||||0.69|TWO_SIDED||||||Mixed Models Analysis|Baseline value adjusted||||||0.69
72466601|NCT02367105|144456578|SUPERIORITY||Mean Difference (Final Values)|7.0||||0.94|TWO_SIDED||||||Mixed Models Analysis|Baseline value adjusted||||||0.94
72466602|NCT02367105|144456579|SUPERIORITY||Mean Difference (Final Values)|-0.5||||0.41|TWO_SIDED||||||Mixed Models Analysis|Baseline value adjusted||||||0.41
72466603|NCT02367105|144456580|SUPERIORITY||Mean Difference (Final Values)|0.5||||0.46|TWO_SIDED||||||Mixed Models Analysis|Baseline values as covariates||||||0.46
72466604|NCT02367105|144456581|SUPERIORITY|Baseline value adjusted|Mean Difference (Final Values)|0.6||||0.96|TWO_SIDED||||||Mixed Models Analysis|||||||0.96
72466605|NCT02367105|144456582|SUPERIORITY||Mean Difference (Final Values)|-0.284||||0.003|TWO_SIDED||||||Mixed Models Analysis|||||||.003
72466606|NCT02367105|144456583|SUPERIORITY||Mean Difference (Final Values)|-0.9||||0.16|TWO_SIDED||||||Mixed Models Analysis|Baseline value and years of education as covariates||||||.16
72466607|NCT02367105|144456584|SUPERIORITY||Mean Difference (Final Values)|-1.8||||0.21|TWO_SIDED||||||Mixed Models Analysis|Baseline values and years of education as covariates||||||0.21
72466608|NCT02367105|144456585|SUPERIORITY||Mean Difference (Final Values)|-0.8||||0.41|TWO_SIDED||||||Mixed Models Analysis|Baseline values and years of education as covariates||||||0.41
72466609|NCT02367105|144456586|SUPERIORITY||Mean Difference (Final Values)|-4.0||||0.03|TWO_SIDED||||||Mixed Models Analysis|Baseline value and years if education as covariates||||||.03
72466610|NCT02367105|144456587|SUPERIORITY||Mean Difference (Final Values)|6.6||||0.03|TWO_SIDED||||||Mixed Models Analysis|Baseline values and years of education as covariates||||||.03
72466611|NCT02367105|144456588|SUPERIORITY||Mean Difference (Final Values)|7.8||||0.18|TWO_SIDED||||||Mixed Models Analysis|Baseline values and years of education as covariates||||||.18
72466612|NCT02367105|144456589|SUPERIORITY||Mean Difference (Final Values)|-1.7||||0.1|TWO_SIDED||||||Mixed Models Analysis|Baseline values and years of education as covariates||||||0.10
72466613|NCT02367105|144456590|SUPERIORITY||Mean Difference (Final Values)|0.01||||0.65|TWO_SIDED||||||Mixed Models Analysis|Baseline values as covariates||||||.65
72466614|NCT02367105|144456591|SUPERIORITY||Mean Difference (Final Values)|0.553||||0.03|TWO_SIDED||||||Mixed Models Analysis|Baseline value adjusted||||||0.03
72621708|NCT03533491|144773643|EQUIVALENCE|A test of the null hypothesis that the pretest to posttest change is equal to zero.|Mean Difference (Final Values)|-0.119|STANDARD_ERROR_OF_MEAN|0.091||0.198|TWO_SIDED||||||t-test, 2 sided|||||||.198
72621709|NCT03533491|144773644|EQUIVALENCE|A test of the null hypothesis that the pretest to posttest change is equal to zero.|Mean Difference (Final Values)|-0.035|STANDARD_ERROR_OF_MEAN|0.121||0.77|TWO_SIDED||||||t-test, 2 sided|A paired t-test that evaluates whether significant pretest to posttest change is different from zero.||||||.770
72466615|NCT02367105|144456592|SUPERIORITY||Mean Difference (Final Values)|-6.5||||0.04|TWO_SIDED||||||Mixed Models Analysis|Baseline value adjusted||||||0.04
72466616|NCT02367105|144456593|SUPERIORITY||Mean Difference (Final Values)|5.5||||0.35|TWO_SIDED|||||Baseline value adjusted|Mixed Models Analysis|||||||0.35
72466617|NCT02367105|144456594|SUPERIORITY||Median Difference (Final Values)|0.01||||0.65|TWO_SIDED||||||Mixed Models Analysis|Baseline value adjusted||||||0.65
72466618|NCT02367105|144456595|SUPERIORITY||Mean Difference (Final Values)|-2.4||||0.27|TWO_SIDED|||||Baseline value adjusted|Mixed Models Analysis|||||||0.27
72466619|NCT02367105|144456596|SUPERIORITY||Mean Difference (Final Values)|-3.6||||0.39|TWO_SIDED|||||Baseline value adjusted|Mixed Models Analysis|||||||0.39
72466620|NCT02367105|144456597|SUPERIORITY||Mean Difference (Final Values)|0.01||||0.58|TWO_SIDED||||||Mixed Models Analysis|||||||0.58
72466621|NCT02367105|144456598|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.9|TWO_SIDED||||||Mixed Models Analysis|Baseline value adjusted||||||0.90
72466622|NCT02367105|144456599|SUPERIORITY||Mean Difference (Final Values)|-252.0|||<|0.001|TWO_SIDED||||||Mixed Models Analysis|Baseline value adjusted||||||<0.001
72503492|NCT01662999|144537961|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric mean|0.927|||||TWO_SIDED|90.0|0.883|0.972|||Mixed Models Analysis|||This analysis assesses the effect of concomitant administration of dapagliflozin on the Pharmacokinetics of saxagliptin. The statistical model includes treatment and period as fixed effects and measurements within each participant as repeated measurements. The adjusted geometric means are from the mixed model.||0.972|0.883|
72503493|NCT01662999|144537963|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric mean|1.055|||||TWO_SIDED|90.0|1.004|1.109|||Mixed Models Analysis|||This analysis assesses the effect of concomitant administration of dapagliflozin on the Pharmacokinetics of 5-OH saxagliptin (metabolite of saxagliptin). The statistical model includes treatment and period as fixed effects and measurements within each participant as repeated measurements. The adjusted geometric means are from the mixed model.||1.109|1.004|
72503494|NCT01662999|144537964|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric mean|0.991|||||TWO_SIDED|90.0|0.96|1.022|||Mixed Models Analysis|||This analysis assesses the effect of concomitant administration of dapagliflozin on the Pharmacokinetics of saxagliptin. The statistical model includes treatment and period as fixed effects and measurements within each participant as repeated measurements. The adjusted geometric means are from the mixed model.||1.022|0.960|
72503495|NCT01662999|144537965|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric mean|0.991|||||TWO_SIDED|90.0|0.961|1.022|||Mixed Models Analysis|||This analysis assesses the effect of concomitant administration of dapagliflozin on the Pharmacokinetics of saxagliptin. The statistical model includes treatment and period as fixed effects and measurements within each participant as repeated measurements. The adjusted geometric means are from the mixed model.||1.022|0.961|
72503496|NCT01662999|144537966|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric mean|1.085|||||TWO_SIDED|90.0|1.058|1.113|||Mixed Models Analysis|||This analysis assesses the effect of concomitant administration of dapagliflozin on the Pharmacokinetics of 5-OH saxagliptin (metabolite). The statistical model includes treatment and period as fixed effects and measurements within each participant as repeated measurements. The adjusted geometric means are from the mixed model.||1.113|1.058|
72466623|NCT02367105|144456600|SUPERIORITY||Mean Difference (Final Values)|-24.9|||<|0.001|TWO_SIDED||||||Mixed Models Analysis|Baseline value as covariates||||||<0.001
72621710|NCT03533491|144773645|EQUIVALENCE|A test of the null hypothesis that the pretest to posttest change is equal to zero.|Mean Difference (Final Values)|-0.029|STANDARD_ERROR_OF_MEAN|0.137||0.834|TWO_SIDED||||||t-test, 2 sided|A paired t-test that evaluates whether significant pretest to posttest change is different from zero.||||||.834
72466624|NCT02367105|144456601|SUPERIORITY||Mean Difference (Final Values)|-2.7|||<|0.001|TWO_SIDED||||||Mixed Models Analysis|Baseline values as covariates||||||<0.001
72466625|NCT02367105|144456602|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.31|TWO_SIDED||||||Mixed Models Analysis|Baseline value adjusted||||||0.31
72466626|NCT02367105|144456603|SUPERIORITY||Mean Difference (Final Values)|-1.2||||0.42|TWO_SIDED|||||Baseline values as covariates|Mixed Models Analysis|||||||0.42
72466627|NCT02367105|144456604|SUPERIORITY||Mean Difference (Final Values)|-0.4||||0.69|TWO_SIDED||||||Mixed Models Analysis|Baseline value adjusted||||||0.69
72466628|NCT02367105|144456605|SUPERIORITY||Mean Difference (Final Values)|-13.1||||0.23|TWO_SIDED||||||Mixed Models Analysis|Baseline value adjusted||||||0.23
72466629|NCT02367105|144456606|SUPERIORITY||Mean Difference (Final Values)|5.3||||0.01|TWO_SIDED||||||Mixed Models Analysis|||||||0.01
72466630|NCT02367105|144456607|SUPERIORITY||Mean Difference (Net)|-1.0||||0.36|TWO_SIDED||||||Mixed Models Analysis|Baseline values as covariates||||||0.36
72466631|NCT02367105|144456608|SUPERIORITY||Mean Difference (Final Values)|-8.6||||0.23|TWO_SIDED||||||Mixed Models Analysis|Baseline values as covariates||||||0.23
72466632|NCT02367105|144456609|SUPERIORITY||Mean Difference (Final Values)|-0.31||||0.69|TWO_SIDED||||||Mixed Models Analysis|Baseline values adjusted||||||0.69
72466633|NCT02367105|144456610|SUPERIORITY||Number of participants|0.0|||>|0.05|TWO_SIDED|||||A priori threshold = voxel p\<.001, cluster p\<.05, false discovery rate (FDR) whole brain correction. There is no correction for multiple seeds given small sample sizes and pre-post design.|t-test, 2 sided|||||||>.05
72466634|NCT02367105|144456611|SUPERIORITY||Mean Difference (Net)|0.23|STANDARD_ERROR_OF_MEAN|0.05||0.37|TWO_SIDED|||||Using DESeq2 R package. P values were adjusted using the Benjamini and Hochberg's approach for controlling the false discovery rate.|t-test, 2 sided|||6 months vs Baseline||||0.37
72466635|NCT02367105|144456611|SUPERIORITY||Mean Difference (Net)|0.58|STANDARD_ERROR_OF_MEAN|0.12||0.02|TWO_SIDED|||||Using DESeq2 R package. P values were adjusted using the Benjamini and Hochberg's approach for controlling the false discovery rate|t-test, 2 sided|||6 months vs Baseline||||.02
72466636|NCT02367105|144456612|SUPERIORITY||Mean Difference (Net)|-0.3|STANDARD_ERROR_OF_MEAN|1.3||0.05|TWO_SIDED||||||Mixed Models Analysis|Final vs baseline||||||.05
72466637|NCT02367105|144456612|SUPERIORITY||Mean Difference (Net)|-0.3|STANDARD_ERROR_OF_MEAN|1.3||0.3|TWO_SIDED||||||Mixed Models Analysis|Final vs baseline||||||0.3
72503497|NCT01662999|144537967|SUPERIORITY_OR_OTHER||ratio of adjusted geometric mean|1.085|||||TWO_SIDED|90.0|1.058|1.113|||Mixed Models Analysis|||This analysis assesses the effect of concomitant administration of dapagliflozin on the Pharmacokinetics of 5-OH saxagliptin (metabolite). The statistical model includes treatment and period as fixed effects and measurements within each participant as repeated measurements. The adjusted geometric means are from the mixed model.||1.113|1.058|
72466638|NCT01657877|144456617|NON_INFERIORITY_OR_EQUIVALENCE|The success criterion for this study was to observe the upper bound of the 2-sided 95% confidence interval for difference in % change in SMHR to be \<= 6 units SMHR i.e. 1500 ppm fluoride as SMFP + 5% CSP is no more than 6 units inferior to the 1500 ppm fluoride as SMFP + 0 % CSP dentifrice.|Adjusted mean difference|-2.23||||0.2601|TWO_SIDED|95.0|-6.11|1.66|||ANOVA|Based on the mixed effects ANOVA considering treatment and study period as factors, and subject as random effect|Difference is 1500 ppm fluoride as SMFP and 0 % CSP minus 1500 ppm fluoride as SMFP and 5 % CSP such that a positive difference favors 1500 ppm fluoride as SMFP and 0 % CSP|The null hypothesis states that the population mean for the 1500 ppm fluoride as SMFP + 0% CSP minus the population mean for the 1500 ppm fluoride as SMFP and 5% CSP dentifrice is more than 6 %.||1.66|-6.11|0.2601
72466639|NCT03398421|144456690|SUPERIORITY||Ratio of adjusted geometric mean|2.005|||||TWO_SIDED|90.0|1.807|2.224||||||||2.224|1.807|
72466640|NCT03398421|144456697|SUPERIORITY||Ratio of adjusted geometric mean|0.802|||||TWO_SIDED|90.0|0.69|0.933||||||||0.933|0.690|
72466641|NCT03269695|144456752|SUPERIORITY||Treatment difference|1.8||||1|TWO_SIDED|95.0|-41.0|47.2|||Chan and Zhang (1999)|||||47.2|-41.0|1.0000
72466642|NCT03269695|144456753|SUPERIORITY||Treatment difference|0.0||||1|TWO_SIDED|95.0|-37.0|37.0|||Chan and Zhang (1999)|||||37.0|-37.0|1.0000
72466643|NCT03269695|144456754|SUPERIORITY||Treatment difference|14.3||||0.47|TWO_SIDED|95.0|-23.8|57.9|||Chan and Zhang (1999)|||||57.9|-23.8|0.4700
72466644|NCT03269695|144456755|SUPERIORITY||Treatment difference|10.0||||0.5221|TWO_SIDED|95.0|-20.7|45.6|||Chan and Zhang (1999)|||||45.6|-20.7|0.5221
72466645|NCT03269695|144456756|SUPERIORITY||Treatment difference|32.1||||0.3166|TWO_SIDED|95.0|-23.7|74.1|||Chan and Zhang (1999)|||||74.1|-23.7|0.3166
72466646|NCT03269695|144456757|SUPERIORITY||Treatment difference|20.0||||0.5234|TWO_SIDED|95.0|-22.9|58.5|||Chan and Zhang (1999)|||||58.5|-22.9|0.5234
72466647|NCT03269695|144456758|SUPERIORITY||Treatment difference|-25.0||||0.7393|TWO_SIDED|95.0|-69.6|29.1|||Chan and Zhang (1999)|||||29.1|-69.6|0.7393
72503498|NCT01662999|144537968|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric mean|0.994|||||TWO_SIDED|90.0|0.96|1.03|||Mixed Models Analysis|||This analysis assesses the effect of concomitant administration of dapagliflozin on the Pharmacokinetics of saxagliptin total active moiety. The statistical model includes treatment and period as fixed effects and measurements within each participant as repeated measurements. The adjusted geometric means are from the mixed model.||1.030|0.960|
72503499|NCT01662999|144537969|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric mean|1.046|||||TWO_SIDED|90.0|1.029|1.064|||Mixed Models Analysis|||This analysis assesses the effect of concomitant administration of dapagliflozin on the AUC(0-T) of saxagliptin total active moiety. The statistical model includes treatment and period as fixed effects and measurements within each participant as repeated measurements. The adjusted geometric means are from the mixed model.||1.064|1.029|
72503500|NCT03851510|144537988|OTHER|95% confidence of prevalence measure.|prevalence|46.3|||||TWO_SIDED|95.0|32.6|60.4||||||All participants that were consented, eligible, and completed the Vector EFL screening (supine).||60.4|32.6|
72621711|NCT03533491|144773646|EQUIVALENCE|A test of the null hypothesis that the pretest to posttest change is equal to zero.|Mean Difference (Final Values)|-0.096|STANDARD_ERROR_OF_MEAN|0.07||0.175|TWO_SIDED||||||t-test, 2 sided|A paired t-test that evaluates whether significant pretest to posttest change is different from zero.||||||.175
72466648|NCT03269695|144456759|SUPERIORITY||Least squares mean difference|5.8||||0.2705|TWO_SIDED|95.0|-5.08|16.67|||ANCOVA|||||16.67|-5.08|0.2705
72466649|NCT03269695|144456760|SUPERIORITY||Treatment difference|48.2||||0.0732|TWO_SIDED|95.0|-4.4|84.7|||Chan and Zhang (1999)|||||84.7|-4.4|0.0732
72466650|NCT03269695|144456761|SUPERIORITY||Treatment difference|30.0||||0.2633|TWO_SIDED|95.0|-18.4|69.2|||Chan and Zhang (1999)|||||69.2|-18.4|0.2633
72466651|NCT03269695|144456762|SUPERIORITY||Odds Ratio (OR)|1.0||||1|TWO_SIDED|95.0|0.15|6.54|||Generalized Linear Mixed Model|||At Week 2||6.54|0.15|1.0000
72466652|NCT03269695|144456762|SUPERIORITY||Odds Ratio (OR)|1.5||||0.6691|TWO_SIDED|95.0|0.23|10.0|||Generalized Linear Mixed Model|||At Week 4||10.00|0.23|0.6691
72466653|NCT03269695|144456762|SUPERIORITY||Odds Ratio (OR)|0.62||||0.6248|TWO_SIDED|95.0|0.09|4.4|||Generalized Linear Mixed Model|||At Week 8||4.40|0.09|0.6248
72466654|NCT03269695|144456762|SUPERIORITY||Odds Ratio (OR)|1.0||||0.9965|TWO_SIDED|95.0|0.12|8.3|||Generalized Linear Mixed Model|||At Week 12||8.30|0.12|0.9965
72466655|NCT01313624|144456789|SUPERIORITY_OR_OTHER||Difference in least squares mean|0.8||||0.68|TWO_SIDED|95.0|-3.1|4.7||P-value was based on T-test from mixed-effect model repeated measures (MMRM).|MMRM|||||4.7|-3.1|0.68
72466656|NCT01313624|144456790|SUPERIORITY_OR_OTHER||Difference in least squares mean|1.3||||0.56|TWO_SIDED|95.0|-3.0|5.6||P-value was based on T-test from mixed-effect model repeated measures (MMRM).|MMRM|||||5.6|-3.0|0.56
72466657|NCT00846768|144456794|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.015|STANDARD_ERROR_OF_MEAN|0.015||0.3011||95.0|-0.014|0.044|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 10 mcg qd minus Olo 5 mcg bid|||0.044|-0.014|0.3011
72466658|NCT00846768|144456794|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.021|STANDARD_ERROR_OF_MEAN|0.015||0.1582||95.0|-0.008|0.05|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 5 mcg qd minus Olo 5 mcg bid|||0.050|-0.008|0.1582
72466659|NCT00846768|144456794|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.054|STANDARD_ERROR_OF_MEAN|0.015||0.0003||95.0|0.025|0.083|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 5 mcg qd minus Olo 2 mcg bid|||0.083|0.025|0.0003
72466660|NCT00846768|144456794|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.006|STANDARD_ERROR_OF_MEAN|0.015||0.7046||95.0|-0.034|0.023|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 10 mcg qd minus Olo 5 mcg qd|||0.023|-0.034|0.7046
72466661|NCT00846768|144456794|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.033|STANDARD_ERROR_OF_MEAN|0.015||0.0248||95.0|0.004|0.063|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 5 mcg bid minus Olo 2 mcg bid|||0.063|0.004|0.0248
72466662|NCT00846768|144456795|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.052|STANDARD_ERROR_OF_MEAN|0.015||0.0006||95.0|-0.081|-0.023|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 10 mcg qd minus Olo 5 mcg bid|||-0.023|-0.081|0.0006
72466663|NCT00846768|144456795|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.047|STANDARD_ERROR_OF_MEAN|0.015||0.0019||95.0|-0.076|-0.017|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 5 mcg qd minus Olo 5 mcg bid|||-0.017|-0.076|0.0019
72466664|NCT00846768|144456795|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.012|STANDARD_ERROR_OF_MEAN|0.015||0.4111||95.0|-0.041|0.017|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 5 mcg qd minus Olo 2 mcg bid|||0.017|-0.041|0.4111
72466665|NCT00846768|144456795|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.006|STANDARD_ERROR_OF_MEAN|0.015||0.709||95.0|-0.035|0.024|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 10 mcg qd minus Olo 5 mcg qd|||0.024|-0.035|0.7090
72466666|NCT00846768|144456795|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.035|STANDARD_ERROR_OF_MEAN|0.015||0.0211||95.0|0.005|0.064|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 5 mcg bid minus Olo 2 mcg bid|||0.064|0.005|0.0211
72466667|NCT00846768|144456796|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.019|STANDARD_ERROR_OF_MEAN|0.014||0.1753||95.0|-0.045|0.008|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 10 mcg qd minus Olo 5 mcg bid|||0.008|-0.045|0.1753
72466668|NCT00846768|144456796|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.013|STANDARD_ERROR_OF_MEAN|0.014||0.3444||95.0|-0.04|0.014|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 5 mcg qd minus Olo 5 mcg bid|||0.014|-0.040|0.3444
72466669|NCT00846768|144456796|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.022|STANDARD_ERROR_OF_MEAN|0.014||0.1161||95.0|-0.005|0.049|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 5 mcg qd minus Olo 2 mcg bid|||0.049|-0.005|0.1161
72503501|NCT01151137|144537993|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.294||||0.0019|TWO_SIDED|95.0|1.337|3.936||A priori threshold for statistical significance: 0.05|Log Rank|2-sided Log-rank's asymptotic test|"Hazard ratio (HR) of Dronedarone versus placebo for stroke, systemic arterial embolism, myocardial infarction or cardiovascular death~HR and confidence interval were estimated using Cox regression model with treatment group as the only factor."|As a consequence of the early termination of the study, the analysis was performed for information only without any adjustment.||3.936|1.337|0.0019
72503502|NCT01151137|144537994|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.947|||<|0.0001|TWO_SIDED|95.0|1.448|2.617||A priori threshold for statistical significance: 0.05|Log Rank|2-sided Log-rank's asymptotic test|"Hazard ratio (HR) of Dronedarone versus placebo for unscheduled cardiovascular hospitalization or death from any cause~HR and confidence interval were estimated using Cox regression model with treatment group as the only factor."|As a consequence of the early termination of the study, the analysis was performed for information only without any adjustment.||2.617|1.448|<0.0001
72503503|NCT01151137|144537996|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.115||||0.046|TWO_SIDED|95.0|0.996|4.49||A priori threshold for statistical significance: 0.05|Log Rank|2-sided Log-rank's asymptotic test|"Hazard ratio (HR) of Dronedarone versus placebo for cardiovascular death~HR and confidence interval were estimated using Cox regression model with treatment group as the only factor."|As a consequence of the early termination of the study, the analysis was performed for information only without any adjustment.||4.490|0.996|0.0460
72503504|NCT00538642|144537999|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||ANOVA|||||||<0.05
72503505|NCT03439345|144538017|SUPERIORITY|For the time-to-event analyses, survival analytic methods will be used to evaluate the time to the first event during the entire study period. Cox proportional hazards regression analyses, adjusted for baseline covariates used in minimised randomisation, will be used to estimate the hazard ratios, 95% confidence intervals and corresponding p-values, comparing all participants allocated active fenofibrate with all those allocated placebo.|Hazard Ratio (HR)|0.73||||0.006|TWO_SIDED|95.0|0.58|0.91|||Regression, Cox|Adjusted for baseline covariates used in minimised randomisation.||||0.91|0.58|0.006
72466670|NCT00846768|144456796|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.006|STANDARD_ERROR_OF_MEAN|0.014||0.6789||95.0|-0.033|0.021|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 10 mcg qd minus Olo 5 mcg qd|||0.021|-0.033|0.6789
72466671|NCT00846768|144456796|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.035|STANDARD_ERROR_OF_MEAN|0.014||0.0129||95.0|0.007|0.062|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 5 mcg bid minus Olo 2 mcg bid|||0.062|0.007|0.0129
72466672|NCT00846768|144456797|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.012|STANDARD_ERROR_OF_MEAN|0.017||0.4931||95.0|-0.023|0.047|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 10 mcg qd minus Olo 5 mcg bid|||0.047|-0.023|0.4931
72466673|NCT00846768|144456797|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.017||0.2597||95.0|-0.015|0.054|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 5 mcg qd minus Olo 5 mcg bid|||0.054|-0.015|0.2597
72466674|NCT00846768|144456797|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.062|STANDARD_ERROR_OF_MEAN|0.018||0.0006||95.0|0.027|0.097|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 5 mcg qd minus Olo 2 mcg bid|||0.097|0.027|0.0006
72466675|NCT00846768|144456797|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.008|STANDARD_ERROR_OF_MEAN|0.017||0.6578||95.0|-0.042|0.027|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 10 mcg qd minus Olo 5 mcg qd|||0.027|-0.042|0.6578
72466676|NCT00846768|144456797|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.042|STANDARD_ERROR_OF_MEAN|0.018||0.0175||95.0|0.008|0.077|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 5 mcg bid minus Olo 2 mcg bid|||0.077|0.008|0.0175
72466677|NCT00846768|144456798|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.042|STANDARD_ERROR_OF_MEAN|0.02||0.0353||95.0|-0.081|-0.003|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 10 mcg qd minus Olo 5 mcg bid|||-0.003|-0.081|0.0353
72466678|NCT00846768|144456798|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.021|STANDARD_ERROR_OF_MEAN|0.02||0.2875||95.0|-0.06|0.018|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 5 mcg qd minus Olo 5 mcg bid|||0.018|-0.060|0.2875
72466679|NCT00846768|144456798|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.015|STANDARD_ERROR_OF_MEAN|0.02||0.4553||95.0|-0.024|0.054|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 5 mcg qd minus Olo 2 mcg bid|||0.054|-0.024|0.4553
72466680|NCT00846768|144456798|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.021|STANDARD_ERROR_OF_MEAN|0.02||0.2902||95.0|-0.06|0.018|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 10 mcg qd minus Olo 5 mcg qd|||0.018|-0.060|0.2902
72466681|NCT00846768|144456798|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.036|STANDARD_ERROR_OF_MEAN|0.02||0.0731||95.0|-0.003|0.075|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 5 mcg bid minus Olo 2 mcg bid|||0.075|-0.003|0.0731
72503506|NCT03439345|144538018|SUPERIORITY|Adjusted for baseline covariates used in minimised randomisation.|Hazard Ratio (HR)|0.72||||0.005|TWO_SIDED|95.0|0.57|0.91|||Regression, Cox|||Cox proportional hazards regression analyses were used to estimate the hazard ratio and 95% confidence intervals, comparing all participants allocated active fenofibrate with all those allocated placebo.||0.91|0.57|0.005
72370715|NCT00488683|144251643|SUPERIORITY_OR_OTHER||R-square|0.21||||||95.0|||||Regression, Linear|||Linear regression coefficient between demographic factors, memory B cells one month after primary vaccination and rise in hSBA after booster vaccination age for the serogroup Y||||
72503507|NCT03439345|144538019|SUPERIORITY|Adjusted for baseline covariates used in minimised randomisation.|Hazard Ratio (HR)|0.58||||0.08|TWO_SIDED|95.0|0.31|1.06|||Regression, Cox|||Cox proportional hazards regression analyses were used to estimate the hazard ratio and 95% confidence intervals, comparing all participants allocated active fenofibrate with all those allocated placebo.||1.06|0.31|0.08
72503508|NCT03439345|144538020|SUPERIORITY|Adjusted for baseline covariates used in minimised randomisation.|Hazard Ratio (HR)|0.74||||0.003|TWO_SIDED|95.0|0.61|0.9|||Regression, Cox|||Cox proportional hazards regression analyses were used to estimate the hazard ratio and 95% confidence intervals, comparing all participants allocated active fenofibrate with all those allocated placebo.||0.90|0.61|0.003
72621712|NCT01725282|144773651|SUPERIORITY_OR_OTHER_LEGACY||Adjusted mean difference|0.2|STANDARD_ERROR_OF_MEAN|1.7|||TWO_SIDED|95.0|-3.1|3.6|||||An analysis of covariance model with the baseline as a covariate and treatment group as a fixed effect.|||3.6|-3.1|
72621713|NCT01725282|144773651|SUPERIORITY_OR_OTHER_LEGACY||Adjusted mean difference|-0.6|STANDARD_ERROR_OF_MEAN|1.7|||TWO_SIDED|95.0|-4.0|2.8|||||An analysis of covariance model with the baseline as a covariate and treatment group as a fixed effect.|||2.8|-4.0|
72621714|NCT01725282|144773651|SUPERIORITY_OR_OTHER_LEGACY||Adjusted mean difference|1.3|STANDARD_ERROR_OF_MEAN|1.7|||TWO_SIDED|95.0|-2.1|4.6|||||An analysis of covariance model with the baseline as a covariate and treatment group as a fixed effect.|||4.6|-2.1|
72621715|NCT05263791|144773660|NON_INFERIORITY|The primary objective to prove the non-inferiority in between the Airmod and reference device is determined by the difference between AirRR and ManCRR.|||||<|0.001|||||||Paired t Test|||Hypothesis: airRR-mancRR ≦ -3, In the target of p\<0.05 indicates significance.||||<0.001
72621716|NCT05263791|144773661|NON_INFERIORITY|The hypothesis tested is demonstrated airRR non-inferior to acoRR when the capnostream is less sensitive.|||||<|0.001|||||||Paired t Test|||"In this study, a non-inferiority test was conducted during periods of reduced sensitivity in capnography to compare respiratory rate measurements using the Airmod device (airRR) versus manually scored auscultation sounds (referred to as acoRR, implying manARR in the statistical analysis plan). The research physician identified periods of reduced sensitivity in capnography."||||<0.001
72466682|NCT00846768|144456799|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.046|STANDARD_ERROR_OF_MEAN|0.027||0.0917||95.0|-0.008|0.099|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 10 mcg qd minus Olo 5 mcg bid|||0.099|-0.008|0.0917
72466683|NCT00846768|144456799|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.041|STANDARD_ERROR_OF_MEAN|0.027||0.1273||95.0|-0.012|0.095|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 5 mcg qd minus Olo 5 mcg bid|||0.095|-0.012|0.1273
72466684|NCT00846768|144456799|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.073|STANDARD_ERROR_OF_MEAN|0.027||0.008||95.0|0.019|0.127|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 5 mcg qd minus Olo 2 mcg bid|||0.127|0.019|0.0080
72466685|NCT00846768|144456799|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.004|STANDARD_ERROR_OF_MEAN|0.027||0.8683||95.0|-0.049|0.058|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 10 mcg qd minus Olo 5 mcg qd|||0.058|-0.049|0.8683
72503509|NCT03439345|144538021|SUPERIORITY|Adjusted for baseline covariates used in minimised randomisation.|Hazard Ratio (HR)|0.66||||0.001|TWO_SIDED|95.0|0.52|0.85|||Regression, Cox|||Cox proportional hazards regression analyses were used to estimate the hazard ratio and 95% confidence intervals, comparing all participants allocated active fenofibrate with all those allocated placebo.||0.85|0.52|0.001
72503510|NCT03439345|144538022|SUPERIORITY|Adjusted for baseline covariates used in minimised randomisation.|Hazard Ratio (HR)|0.5||||0.008|TWO_SIDED|95.0|0.3|0.84|||Regression, Cox|||Cox proportional hazards regression analyses were used to estimate the hazard ratio and 95% confidence intervals, comparing all participants allocated active fenofibrate with all those allocated placebo.||0.84|0.30|0.008
72466686|NCT00846768|144456799|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.032|STANDARD_ERROR_OF_MEAN|0.027||0.2444||95.0|-0.022|0.086|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 5 mcg bid minus Olo 2 mcg bid|||0.086|-0.022|0.2444
72503511|NCT03439345|144538023|SUPERIORITY|Adjusted for baseline covariates used in minimised randomisation and for the baseline visual acuity.|Mean Difference (Final Values)|0.0||||0.36|TWO_SIDED|95.0|-0.01|0.01|||Regression, Cox|||The estimates were derived from linear mixed model repeated measures.||0.01|-0.01|0.36
72503512|NCT03439345|144538024|SUPERIORITY|Adjusted for baseline covariates used in minimised randomisation and for baseline VFQ-25 composite score.|Mean Difference (Final Values)|0.0||||0.58|TWO_SIDED|95.0|-1.0|1.0|||Regression, Cox|||The estimates were derived from linear mixed model repeated measures.||1|-1|0.58
72503513|NCT03439345|144538025|SUPERIORITY|Adjusted for baseline covariates used in minimised randomisation and for baseline EQ-5D Index Score.|Mean Difference (Final Values)|0.0||||0.93|TWO_SIDED|95.0|-0.02|0.02|||Regression, Cox|||The estimates were derived from linear mixed model repeated measures.||0.02|-0.02|0.93
72503514|NCT03439345|144538026|SUPERIORITY|Adjusted for baseline covariates used in minimised randomisation and for baseline EQ-5D Visual Analogue Score.|Mean Difference (Final Values)|-1.0||||0.43|TWO_SIDED|95.0|-2.0|1.0|||Regression, Cox|||The estimates were derived from a linear mixed model repeated measures||1|-2|0.43
72503515|NCT03439345|144538027|OTHER||Mean Difference (Final Values)|-254.0|||||TWO_SIDED|95.0|-1062.0|624.0||||||||624|-1062|
72503516|NCT03439345|144538028|OTHER||Incremental cost-effectiveness ratio|614.0|||||TWO_SIDED||||||||£614 cost per QALY gained based on probabilistic analysis|||||
72503517|NCT03439345|144538029|SUPERIORITY|Adjusted for baseline covariates used in minimised randomisation.|Hazard Ratio (HR)|0.76|||||TWO_SIDED|95.0|0.58|0.99||||||Cox proportional hazards regression analyses were used to estimate the hazard ratio and 95% confidence intervals, comparing all participants allocated active fenofibrate with all those allocated placebo.||0.99|0.58|
72503518|NCT03439345|144538030|SUPERIORITY|Adjusted for baseline covariates used in minimised randomisation.|Hazard Ratio (HR)|0.64|||||TWO_SIDED|95.0|0.4|1.0||||||Cox proportional hazards regression analyses were used to estimate the hazard ratio and 95% confidence intervals, comparing all participants allocated active fenofibrate with all those allocated placebo.||1.00|0.40|
72503519|NCT03439345|144538031|SUPERIORITY|Adjusted for baseline covariates used in minimised randomisation.|Hazard Ratio (HR)|0.71|||||TWO_SIDED|95.0|0.52|0.97||||||Cox proportional hazards regression analyses were used to estimate the hazard ratio and 95% confidence intervals, comparing all participants allocated active fenofibrate with all those allocated placebo.||0.97|0.52|
72503520|NCT03439345|144538032|SUPERIORITY|Adjusted for baseline covariates used in minimised randomisation.|Hazard Ratio (HR)|0.77|||||TWO_SIDED|95.0|0.55|1.07||||||Cox proportional hazards regression analyses were used to estimate the hazard ratio and 95% confidence intervals, comparing all participants allocated active fenofibrate with all those allocated placebo.||1.07|0.55|
72370716|NCT00488683|144251643|SUPERIORITY_OR_OTHER||R-square|0.12||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between demographic factors, memory B cells one month after primary vaccination and rise in hSBA after booster vaccination age for the serogroup Y||||
72466687|NCT00846768|144456800|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.099|STANDARD_ERROR_OF_MEAN|0.032||0.0023||95.0|-0.162|-0.036|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 10 mcg qd minus Olo 5 mcg bid|||-0.036|-0.162|0.0023
72466688|NCT00846768|144456800|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.103|STANDARD_ERROR_OF_MEAN|0.032||0.0015||95.0|-0.165|-0.04|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 5 mcg qd minus Olo 5 mcg bid|||-0.040|-0.165|0.0015
72621717|NCT05263791|144773663|SUPERIORITY|This analysis were examined to assess the responsiveness of Airmod and Capnography.|||||<|0.001|||||||Paired t Test|||The hypothesis tested whether the response times obtained with the Airmod device were equal to those recorded with Capnography.||||<0.001
72466689|NCT00846768|144456800|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.024|STANDARD_ERROR_OF_MEAN|0.032||0.4508||95.0|-0.087|0.039|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 5 mcg qd minus Olo 2 mcg bid|||0.039|-0.087|0.4508
72466690|NCT00846768|144456800|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.004|STANDARD_ERROR_OF_MEAN|0.032||0.9087||95.0|-0.059|0.066|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 10 mcg qd minus Olo 5 mcg qd|||0.066|-0.059|0.9087
72466691|NCT00846768|144456800|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.079|STANDARD_ERROR_OF_MEAN|0.032||0.0146||95.0|0.016|0.142|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 5 mcg bid minus Olo 2 mcg bid|||0.142|0.016|0.0146
72503521|NCT03439345|144538033|SUPERIORITY|Adjusted for baseline covariates used in minimised randomisation.|Hazard Ratio (HR)|0.78|||||TWO_SIDED|95.0|0.51|1.21||||||Cox proportional hazards regression analyses were used to estimate the hazard ratio and 95% confidence intervals, comparing all participants allocated active fenofibrate with all those allocated placebo.||1.21|0.51|
72503522|NCT03439345|144538034|SUPERIORITY|Adjusted for baseline covariates used in minimised randomisation.|Hazard Ratio (HR)|0.71|||||TWO_SIDED|95.0|0.54|0.93||||||Cox proportional hazards regression analyses were used to estimate the hazard ratio and 95% confidence intervals, comparing all participants allocated active fenofibrate with all those allocated placebo.||0.93|0.54|
72503523|NCT03439345|144538035|SUPERIORITY|Adjusted for baseline covariates used in minimised randomisation.|Hazard Ratio (HR)|0.51|||||TWO_SIDED|95.0|0.28|0.93||||||Cox proportional hazards regression analyses were used to estimate the hazard ratio and 95% confidence intervals, comparing all participants allocated active fenofibrate with all those allocated placebo.||0.93|0.28|
72503524|NCT03439345|144538036|SUPERIORITY|Adjusted for baseline covariates used in minimised randomisation.|Hazard Ratio (HR)|0.77|||||TWO_SIDED|95.0|0.6|0.99||||||Cox proportional hazards regression analyses were used to estimate the hazard ratio and 95% confidence intervals, comparing all participants allocated active fenofibrate with all those allocated placebo.||0.99|0.60|
72564627|NCT02631837|144660811|SUPERIORITY|We tested a treatment arm by time interaction to study changes in differences for the outcomes during the follow-up period. In absence of such an interaction (p\>0.05 for the interaction term), the main effect of treatment was tested.||||||0.3473||||||We tested a treatment arm by time interaction to study changes in differences for the outcomes during the follow-up period. In absence of such an interaction (p\>0.05 for the interaction term), the main effect of treatment was tested.|Arm by time interaction|||||||0.3473
72564628|NCT02631837|144660813|SUPERIORITY||Mean Difference (Final Values)|-555.8||||0.11|TWO_SIDED|95.0||36.0|||Mann-Whitney U test|||||36|-1,044|0.110
72564629|NCT03346070|144660814|SUPERIORITY||Hazard Ratio (HR)|1.92||||0.0075|TWO_SIDED|95.0|1.18|3.1|||Log Rank||Cox regression model|||3.10|1.18|0.0075
72564630|NCT03346070|144660814|SUPERIORITY||Hazard Ratio (HR)|25.9|||<|0.0001|TWO_SIDED|95.0|9.72|69.03|||Log Rank||Cox regression model|||69.03|9.72|<0.0001
72564631|NCT03346070|144660814|SUPERIORITY||Hazard Ratio (HR)|61.4|||<|0.0001|TWO_SIDED|95.0|14.13|266.77|||Log Rank||Cox regression model|||266.77|14.13|<0.0001
72564632|NCT03346070|144660814|SUPERIORITY||Hazard Ratio (HR)|2.38||||0.0005|TWO_SIDED|95.0|1.44|3.93|||Log Rank||Cox regression model|||3.93|1.44|0.0005
72564633|NCT03346070|144660814|SUPERIORITY||Hazard Ratio (HR)|2.13|||<|0.0001|TWO_SIDED|95.0|1.5|3.01|||Log Rank||Cox regression model|||3.01|1.50|<0.0001
72564634|NCT03346070|144660815|SUPERIORITY||Difference in percentage|2.3||||0.602|TWO_SIDED|95.0|-9.6|15.0|||Miettinen & Nurminen method|||||15.0|-9.6|0.602
72564635|NCT03346070|144660815|SUPERIORITY||Difference in percentage|0.2||||0.969|TWO_SIDED|95.0|-13.4|13.5|||Miettinen & Nurminen method|||||13.5|-13.4|0.969
72564636|NCT03346070|144660815|SUPERIORITY||Difference in percentage|2.6||||0.567|TWO_SIDED|95.0|-8.7|15.0|||Miettinen & Nurminen method|||||15.0|-8.7|0.567
72564637|NCT03346070|144660815|SUPERIORITY||Difference in percentage|2.6||||0.571|TWO_SIDED|95.0|-8.8|15.0|||Miettinen & Nurminen method|||||15.0|-8.8|0.571
72503525|NCT03439345|144538037|SUPERIORITY|Adjusted for baseline covariates used in minimised randomisation.|Hazard Ratio (HR)|0.68|||||TWO_SIDED|95.0|0.49|0.95||||||Cox proportional hazards regression analyses were used to estimate the hazard ratio and 95% confidence intervals, comparing all participants allocated active fenofibrate with all those allocated placebo.||0.95|0.49|
72564638|NCT03346070|144660815|SUPERIORITY||Difference in percentage|-0.2||||0.95|TWO_SIDED|95.0|-11.6|10.9|||Miettinen & Nurminen method|||||10.9|-11.6|0.950
72564639|NCT03346070|144660815|SUPERIORITY||Difference in percentage|2.9||||0.528|TWO_SIDED|95.0|-8.4|15.9|||Miettinen & Nurminen method|||||15.9|-8.4|0.528
72564640|NCT03346070|144660815|SUPERIORITY||Difference in percentage|1.3||||0.709|TWO_SIDED|95.0|-6.8|9.6|||Miettinen & Nurminen method|||||9.6|-6.8|0.709
72564641|NCT03346070|144660816|SUPERIORITY||Difference in percentage|2.2||||0.738|TWO_SIDED|95.0|-12.3|17.4|||Miettinen & Nurminen method|||||17.4|-12.3|0.738
72564642|NCT03346070|144660816|SUPERIORITY||Difference in percentage|11.1||||0.077|TWO_SIDED|95.0|-1.7|26.3|||Miettinen & Nurminen method|||||26.3|-1.7|0.077
72564643|NCT03346070|144660816|SUPERIORITY||Difference in percentage|2.4||||0.717|TWO_SIDED|95.0|-12.0|16.4|||Miettinen & Nurminen method|||||16.4|-12.0|0.717
72564644|NCT03346070|144660816|SUPERIORITY||Difference in percentage|5.0||||0.486|TWO_SIDED|95.0|-9.9|19.7|||Miettinen & Nurminen method|||||19.7|-9.9|0.486
72564645|NCT03346070|144660816|SUPERIORITY||Difference in percentage|-1.2||||0.849|TWO_SIDED|95.0|-16.2|12.4|||Miettinen & Nurminen method|||||12.4|-16.2|0.849
72564646|NCT03346070|144660816|SUPERIORITY||Difference in percentage|-4.9||||0.339|TWO_SIDED|95.0|-18.2|6.7|||Miettinen & Nurminen method|||||6.7|-18.2|0.339
72564647|NCT03346070|144660816|SUPERIORITY||Difference in percentage|6.6||||0.149|TWO_SIDED|95.0|-2.6|16.8|||Miettinen & Nurminen method|||||16.8|-2.6|0.149
72621718|NCT05263791|144773664|NON_INFERIORITY|The objective to prove the non-inferiority in between the Airmod and reference device is determined by the difference between AirRR and ManCRR by subjects.|||||<|0.05|||||||Paired t Test|||Hypothesis: airRR-mancRR ≦ -2, In the target of p\<0.05 indicates significance.||||<0.05
72621719|NCT04576481|144773668|SUPERIORITY||F-Statistic|1.18||||0.32|TWO_SIDED||||||ANOVA|||Analysis of Variance statistical testing.||||0.32
72621720|NCT04576481|144773669|SUPERIORITY||F-Statistic|0.25||||0.78|TWO_SIDED||||||ANOVA|||||||0.78
72621721|NCT04576481|144773670|SUPERIORITY|||||||0.19|||||||ANOVA|||||||0.19
72621722|NCT04576481|144773671|SUPERIORITY|||||||0.46|||||||ANOVA|||||||0.46
72621723|NCT04576481|144773672|SUPERIORITY|||||||0.3|||||||ANOVA|||||||0.30
72621724|NCT04204902|144773702|EQUIVALENCE|Analysis was performed with Equivalence Acceptance Range for 90 percentage Confidence Interval (CI) as 80.00 percentage - 125.00 percentage|Ratio of Geometric Least Square Mean|91.15|||||TWO_SIDED|90.0|83.21|99.84||||||||99.84|83.21|
72621725|NCT04204902|144773703|EQUIVALENCE|Analysis was performed with Equivalence Acceptance Range for 90 percentage Confidence Interval (CI) as 80.00 percentage - 125.00 percentage|Ratio of Geometric Least square Mean|90.92|||||TWO_SIDED|90.0|82.99|99.61||||||||99.61|82.99|
72621726|NCT04204902|144773704|EQUIVALENCE|Analysis was performed with Equivalence Acceptance Range for 90 percentage Confidence Interval (CI) as 80.00 percentage - 125.00 percentage|Ratio of Geometric Least Square Mean|104.62|||||TWO_SIDED|90.0|95.17|115.0||||||||115.00|95.17|
72621727|NCT00928720|144773715|SUPERIORITY||Mean Difference (Final Values)|0.05||||0.045|TWO_SIDED||||||Mixed Models Analysis|||||||0.045
72621728|NCT02034565|144773724|SUPERIORITY_OR_OTHER||Ratio of Adjusted Geometric Means|0.977|||||TWO_SIDED|90.0|0.756|1.261||||||||1.261|0.756|
72621729|NCT02034565|144773725|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|1.05|||||TWO_SIDED|90.0|0.938|1.176||||||||1.176|0.938|
72621730|NCT02034565|144773726|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|1.043|||||TWO_SIDED|90.0|0.933|1.167||||||||1.167|0.933|
72394560|NCT02310568|144295790|SUPERIORITY_OR_OTHER||LS Mean Difference|0.6|STANDARD_ERROR_OF_MEAN|0.66||0.412|TWO_SIDED|90.0|-0.6|1.7|||ANCOVA|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Family Sub-Scale Score (Combined Stage 1 and Stage 2): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.||1.7|-0.6|0.412
72466692|NCT00846768|144456801|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.027|STANDARD_ERROR_OF_MEAN|0.027||0.3291||95.0|-0.08|0.027|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 10 mcg qd minus Olo 5 mcg bid|||0.027|-0.080|0.3291
72466693|NCT00846768|144456801|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.03|STANDARD_ERROR_OF_MEAN|0.027||0.2638||95.0|-0.084|0.023|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 5 mcg qd minus Olo 5 mcg bid|||0.023|-0.084|0.2638
72466694|NCT00846768|144456801|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.026|STANDARD_ERROR_OF_MEAN|0.027||0.3386||95.0|-0.028|0.08|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 5 mcg qd minus Olo 2 mcg bid|||0.080|-0.028|0.3386
72466695|NCT00846768|144456801|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.004|STANDARD_ERROR_OF_MEAN|0.027||0.8877||95.0|-0.05|0.057|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 10 mcg qd minus Olo 5 mcg qd|||0.057|-0.050|0.8877
72466696|NCT00846768|144456801|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.057|STANDARD_ERROR_OF_MEAN|0.027||0.0402||95.0|0.003|0.111|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 5 mcg bid minus Olo 2 mcg bid|||0.111|0.003|0.0402
72466697|NCT00846768|144456802|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.084|STANDARD_ERROR_OF_MEAN|0.034||0.0133||95.0|0.018|0.151|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 10 mcg qd minus Olo 5 mcg bid|||0.151|0.018|0.0133
72503526|NCT03439345|144538038|SUPERIORITY|Adjusted for baseline covariates used in minimised randomisation.|Hazard Ratio (HR)|0.75|||||TWO_SIDED|95.0|0.53|1.06||||||Cox proportional hazards regression analyses were used to estimate the hazard ratio and 95% confidence intervals, comparing all participants allocated active fenofibrate with all those allocated placebo.||1.06|0.53|
72503527|NCT03439345|144538039|SUPERIORITY|Adjusted for baseline covariates used in minimised randomisation.|Hazard Ratio (HR)|1.4|||||TWO_SIDED|95.0|0.55|3.57||||||Cox proportional hazards regression analyses were used to estimate the hazard ratio and 95% confidence intervals, comparing all participants allocated active fenofibrate with all those allocated placebo.||3.57|0.55|
72503528|NCT03439345|144538040|SUPERIORITY|Adjusted for baseline covariates used in minimised randomisation.|Hazard Ratio (HR)|0.7|||||TWO_SIDED|95.0|0.48|1.03||||||Cox proportional hazards regression analyses were used to estimate the hazard ratio and 95% confidence intervals, comparing all participants allocated active fenofibrate with all those allocated placebo.||1.03|0.48|
72503529|NCT03439345|144538041|SUPERIORITY|Adjusted for baseline covariates used in minimised randomisation.|Hazard Ratio (HR)|0.74|||||TWO_SIDED|95.0|0.56|0.99||||||Cox proportional hazards regression analyses were used to estimate the hazard ratio and 95% confidence intervals, comparing all participants allocated active fenofibrate with all those allocated placebo.||0.99|0.56|
72503530|NCT03439345|144538042|SUPERIORITY|Adjusted for baseline covariates used in minimised randomisation and for the baseline UACR.|Hazard Ratio (HR)|-12.4|||||TWO_SIDED|95.0|-25.8|3.5|||||Estimates are in %.|Linear mixed model repeated measures analyses were conducted to estimate the trial-averaged percentage difference in geometric mean UACR between the randomised treatment groups. UACR data at baseline was available for 312 participants allocated fenofibrate and 310 participants allocated placebo.||3.5|-25.8|
72503531|NCT03439345|144538043|SUPERIORITY|"Adjusted for baseline covariates used in minimised randomisation.~."|Hazard Ratio (HR)|1.05|||||TWO_SIDED|95.0|0.69|1.6||||||Cox proportional hazards regression analyses were used to estimate the hazard ratio and 95% confidence intervals, comparing all participants allocated active fenofibrate with all those allocated placebo.||1.60|0.69|
72503532|NCT03439345|144538044|SUPERIORITY|Adjusted for baseline covariates used in minimised randomisation.|Hazard Ratio (HR)|0.35|||||TWO_SIDED|95.0|0.11|1.12||||||Cox proportional hazards regression analyses were used to estimate the hazard ratio and 95% confidence intervals, comparing all participants allocated active fenofibrate with all those allocated placebo.||1.12|0.11|
72503533|NCT05165394|144538047|SUPERIORITY||Least-Squares Mean Treatment Difference|-3.9|STANDARD_ERROR_OF_MEAN|3.5||0.8663|ONE_SIDED|90.0|-8.4|||Significance level = 0.1|ANCOVA||Confidence interval and p-value are one-sided for test of null hypothesis that the LS mean difference between NBI-1065846 and placebo in DARS total score at Day 57 is greater than or equal to zero.||||-8.4|0.8663
72503534|NCT05165394|144538048|SUPERIORITY||Least-Squares Mean Treatment Difference|-1.1|STANDARD_ERROR_OF_MEAN|3.0||0.7008|TWO_SIDED|95.0|-7.1|4.8|||ANCOVA||NBI-1065846 - Placebo|||4.8|-7.1|0.7008
72503535|NCT05165394|144538049|SUPERIORITY|||||||0.9051|||||||Cochran-Mantel-Haenszel Chi-square test|||CGI-S scores at Day 57 for NBI-1065846 compared to placebo.||||0.9051
72466698|NCT00846768|144456802|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.068|STANDARD_ERROR_OF_MEAN|0.034||0.045||95.0|0.002|0.135|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 5 mcg qd minus Olo 5 mcg bid|||0.135|0.002|0.0450
72466699|NCT00846768|144456802|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.092|STANDARD_ERROR_OF_MEAN|0.034||0.0078||95.0|0.025|0.159|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 5 mcg qd minus Olo 2 mcg bid|||0.159|0.025|0.0078
72466700|NCT00846768|144456802|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.016|STANDARD_ERROR_OF_MEAN|0.034||0.6268||95.0|-0.05|0.083|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 10 mcg qd minus Olo 5 mcg qd|||0.083|-0.050|0.6268
72466701|NCT00846768|144456802|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.024|STANDARD_ERROR_OF_MEAN|0.034||0.4891||95.0|-0.044|0.091|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 5 mcg bid minus Olo 2 mcg bid|||0.091|-0.044|0.4891
72503536|NCT01332435|144538050|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||||||<0.001
72466702|NCT00846768|144456803|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.019|STANDARD_ERROR_OF_MEAN|0.04||0.6259||95.0|-0.097|0.059|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 10 mcg qd minus Olo 5 mcg bid|||0.059|-0.097|0.6259
72466703|NCT00846768|144456803|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.004|STANDARD_ERROR_OF_MEAN|0.039||0.919||95.0|-0.082|0.074|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 5 mcg qd minus Olo 5 mcg bid|||0.074|-0.082|0.9190
72466704|NCT00846768|144456803|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.066|STANDARD_ERROR_OF_MEAN|0.04||0.0985||95.0|-0.012|0.145|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 5 mcg qd minus Olo 2 mcg bid|||0.145|-0.012|0.0985
72466705|NCT00846768|144456803|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.015|STANDARD_ERROR_OF_MEAN|0.039||0.6991||95.0|-0.093|0.063|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 10 mcg qd minus Olo 5 mcg qd|||0.063|-0.093|0.6991
72466706|NCT00846768|144456803|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.07|STANDARD_ERROR_OF_MEAN|0.04||0.0802||95.0|-0.009|0.149|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 5 mcg bid minus Olo 2 mcg bid|||0.149|-0.009|0.0802
72466707|NCT03121612|144456820|SUPERIORITY|Power calculated based on 40 infants in each arm, permitting detection of a difference of 0.67 SD between the groups with power of 80% and alpha=0.05. Study recruitment was below anticipated (51/80) despite extending the planned period of recruitment.||||||0.65||||||Threshold for superiority p\<0.05; primary outcome, so not adjusted for multiple comparisons.|van Elteren's extension to Wilcoxon|van Elteren's extension used to control for stratification by gestation||"Analysis restricted to change at 6 hours, as least affected by missing data.~Distribution non-normal, so non-parametric test (Wilcoxon) used."||||0.65
72503537|NCT01332435|144538050|SUPERIORITY_OR_OTHER|||||||0.0002||95.0|||||Chi-squared|||||||0.0002
72503538|NCT01332435|144538051|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||||||<0.001
72503539|NCT01332435|144538051|SUPERIORITY_OR_OTHER|||||||0.0006||95.0|||||Chi-squared|||||||0.0006
72503540|NCT01332435|144538052|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||||||<0.001
72564648|NCT03346070|144660817|SUPERIORITY||Difference in percentage|-2.7||||0.299|TWO_SIDED|95.0|-13.9|6.7|||Miettinen & Nurminen method|||||6.7|-13.9|0.299
72503541|NCT01332435|144538052|SUPERIORITY_OR_OTHER|||||||0.0699||95.0|||||Chi-squared|||||||0.0699
72370717|NCT00488683|144251643|SUPERIORITY_OR_OTHER||R-square|0.0015||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and rise in serogroup specific IgG concentration after booster vaccination age for the serogroup A||||
72503542|NCT01332435|144538053|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Regression, Linear|||||||<0.001
72503543|NCT01332435|144538053|SUPERIORITY_OR_OTHER|||||||0.8645||95.0|||||Regression, Linear|||||||0.8645
72564649|NCT03346070|144660817|SUPERIORITY||Difference in percentage|0.0|||>|0.999|TWO_SIDED|95.0|-9.9|9.4|||Miettinen & Nurminen method|||||9.4|-9.9|>0.999
72466708|NCT03121612|144456820|SUPERIORITY|||||||0.64|||||||Wilcoxon (Mann-Whitney)|||Planned sub-group analysis for infants born at 28-33 gestational weeks (n=41). No adjustment for multiple comparisons.||||0.64
72466709|NCT03121612|144456820|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Planned sub-group analysis for infants born at 34-36 gestational weeks (n=10). No adjustment for multiple comparisons.||||1.0
72466710|NCT03121612|144456821|SUPERIORITY|Power calculated based on 40 infants in each arm, permitting detection of a difference of 0.67 SD between the groups with power of 80% and alpha=0.05. Study recruitment was below anticipated (51/80) despite extending the planned period of recruitment.||||||0.8||||||Threshold for superiority p\<0.05; not adjusted for multiple comparisons|van Elteren's extension to Wilcoxon|van Elteren's extension used to control for stratification by gestation.||"Analysis restricted to change at 6 hours, as least affected by missing data.~Distribution not normal by visual examination, so non-parametric test (Wilcoxon) used."||||0.80
72503544|NCT01332435|144538054|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Regression, Linear|||||||<0.001
72503545|NCT01332435|144538054|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Regression, Linear|||||||<0.001
72503546|NCT00492622|144538056|EQUIVALENCE|Primary study objective was to compare the pharmacokinetics of omeprazole between IR and DR omeprazole in patients with GERD associated with gastroparesis.|||||<|0.01||||||\<0.01 is used for determining the level of significance.|paired t-tests|||||||< 0.01
72503547|NCT00492622|144538057|EQUIVALENCE|Primary study objective was to compare the pharmacokinetics of omeprazole between IR and DR omeprazole in patients with GERD associated with gastroparesis.|||||||||||||||||P\<0.05 was used as the level of significance with ANOVA for this endpoint.|||
72503548|NCT00492622|144538058|EQUIVALENCE|Primary study objective was to compare the pharmacokinetics of omeprazole between IR and DR omeprazole in patients with GERD associated with gastroparesis.||||||0.95||||||An analysis of variance model was used to compare AUC between IR and DR omeprazole using the natural logarithmic transformation. The model included the following factors: treatment, period, sequence and patient nested within the sequence.|ANOVA|||||||0.95
72564650|NCT03346070|144660817|SUPERIORITY||Difference in percentage|-2.6||||0.326|TWO_SIDED|95.0|-13.7|7.0|||Miettinen & Nurminen method|||||7.0|-13.7|0.326
72621731|NCT00967486|144773786|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Fisher Exact|||||||<0.05
72621732|NCT00489476|144773830|SUPERIORITY|||||||0.0212|||||||Fisher Exact|||||||0.0212
72621733|NCT00489476|144773830|SUPERIORITY|||||||0.0106|||||||Fisher Exact|||||||0.0106
72621734|NCT00489476|144773831|SUPERIORITY|||||||0.0123|||||||Fisher Exact|||||||0.0123
72621735|NCT00489476|144773831|SUPERIORITY|||||||0.0228|||||||Fisher Exact|||||||0.0228
72621736|NCT00489476|144773832|SUPERIORITY|||||||0.0409|||||||Fisher Exact|||||||0.0409
72466711|NCT03121612|144456822|SUPERIORITY|Power calculated based on 40 infants in each arm, permitting detection of a difference of 0.67 SD between the groups with power of 80% and alpha=0.05. Study recruitment was below anticipated (51/80) despite extending the planned period of recruitment.||||||0.86||||||Threshold for superiority p\<0.05; not adjusted for multiple comparisons.|van Elteren's extension to Wilcoxon|van Elteren's extension used to control for stratification by gestation.||"Analysis restricted to change at 6 hours, as least affected by missing data.~Distribution non-normal, so non-parametric test (Wilcoxon) used."||||0.86
72621737|NCT04105725|144773841|SUPERIORITY||||||<|0.05|||||||negative binomial regression|||||||<0.05
72621738|NCT00480025|144773848|SUPERIORITY|RMF included: 1) Number of chemotherapy cycles received (1, 2 vs. 3, 4), if any; 2) Pathological stage of the disease (IB vs. II vs. IIIA); 3) Type of lymph-node sampling (minimal lymph-node sampling vs. systematic radical mediastinal lymphadenectomy); 4) ECOG performance status randomization (0, 1 vs. 2); 5) Smoking status ( 100 cigarettes a lifetime vs. \> 100 cigarettes and current smoker vs. \>100 cigarettes and past smoker).|Treatment Efficacy|1.024||||0.7379|TWO_SIDED|95.0|0.891|1.177||2-sided p-value of Likelihood Ratio test from RMF-adjusted Cox regression, Efron method used to handle ties.|Regression, Cox|Overall population objective reached if p-value \< 2.56%/4% in absence/presence of statistically significant effect in the No-CT population.||Analysis compared DFS PYAR between groups for period from 1st treatment dose to DLP. A Cox model was used to evaluate treatment efficacy (TE). TE was calculated as PYAR in GSK1572932 Group (PYAR1) divided by PYAR in Placebo Group (PYAR2), and weighed for adjustment factors. This comparison in all patients (overall population) also included taking into account stratification by previous CT vs. No-CT treatment and weighing using randomization-minimization factors (RMF) as regressors.||1.177|0.891|0.7379
72621739|NCT00480025|144773849|SUPERIORITY|RMF taken into account included: 1) Number of chemotherapy cycles received (1, 2 vs. 3, 4), if any; 2) Pathological stage of the disease (IB vs. II vs. IIIA); 3) Type of lymph-node sampling (minimal lymph-node sampling vs. systematic radical mediastinal lymphadenectomy); 4) ECOG performance status randomization (0, 1 vs. 2); 5) Smoking status ( 100 cigarettes a lifetime vs. \> 100 cigarettes and current smoker vs. \> 100 cigarettes and past smoker).|Treatment Efficacy|0.97||||0.7572|TWO_SIDED|95.0|0.797|1.179||2-sided p-value of Likelihood Ratio test from RMF-adjusted Cox regression, Efron method used to handle ties.|Regression, Cox|No-CT population objective reached if p-value \< 2.56%/4% in absence/presence of statistically significant effect in the No-CT population.||Analysis compared DFS PYAR between groups for the period from 1st treatment dose to DLP. A Cox model was used to evaluate treatment efficacy (TE). TE was calculated as PYAR in GSK1572932 No-CT Group (PYAR1) divided by PYAR in Placebo No-CT Group (PYAR2) and weighed for adjustment factors. This comparison in all patients (overall population) also included taking into account weighing using randomization-minimization factors (RMF) as regressors.||1.179|0.797|0.7572
72621740|NCT03726879|144773885|SUPERIORITY||Odds Ratio (OR)|0.67||||0.1846|TWO_SIDED|95.0|0.37|1.21||The threshold for statistical significance was a p-value =0.048|Cochran-Mantel-Haenszel|||||1.21|0.37|0.1846
72621741|NCT03726879|144773886|SUPERIORITY||Odds Ratio (OR)|0.99||||0.9551|TWO_SIDED|95.0|0.67|1.46||The threshold for statistical significance was a p-value =0.002|Cochran-Mantel-Haenszel|||||1.46|0.67|0.9551
72621742|NCT03726879|144773889|SUPERIORITY||Hazard Ratio (HR)|0.9|||||TWO_SIDED|95.0|0.5|1.59|||Log Rank|||All Participants||1.59|0.50|
72621743|NCT03726879|144773889|SUPERIORITY||Hazard Ratio (HR)|1.67|||||TWO_SIDED|95.0|0.65|4.32|||Log Rank|||PD-L1 IC1/2/3||4.32|0.65|
72621744|NCT03726879|144773889|SUPERIORITY||Hazard Ratio (HR)|0.58|||||TWO_SIDED|95.0|0.27|1.22|||Log Rank|||PD-L1 IC0 Participants||1.22|0.27|
72621745|NCT03726879|144773889|SUPERIORITY||Hazard Ratio (HR)|1.28|||||TWO_SIDED|95.0|0.58|2.82|||Log Rank|||ER/PgR Negative Participants||2.82|0.58|
72621746|NCT03726879|144773889|SUPERIORITY||Hazard Ratio (HR)|0.57|||||TWO_SIDED|95.0|0.24|1.36|||Log Rank|||ER/PgR Positive Participants||1.36|0.24|
72621747|NCT03726879|144773890|SUPERIORITY||Hazard Ratio (HR)|0.71|||||TWO_SIDED|95.0|0.38|1.32|||Log Rank|||All Participants||1.32|0.38|
72621748|NCT03726879|144773890|SUPERIORITY||Hazard Ratio (HR)|1.38|||||TWO_SIDED|95.0|0.51|3.69|||Log Rank|||PD-L1 IC1/2/3||3.69|0.51|
72621749|NCT03726879|144773890|SUPERIORITY||Hazard Ratio (HR)|0.44|||||TWO_SIDED|95.0|0.19|1.02|||Log Rank|||PD-L1 IC0||1.02|0.19|
72621750|NCT03726879|144773891|SUPERIORITY||Hazard Ratio (HR)|0.89|||||TWO_SIDED|95.0|0.4|2.0|||Log Rank|||All Participants||2.00|0.40|
72621751|NCT03726879|144773891|SUPERIORITY||Hazard Ratio (HR)|1.75|||||TWO_SIDED|95.0|0.42|7.33|||Log Rank|||PD-L1 IC1/2/3||7.33|0.42|
72621752|NCT03726879|144773891|SUPERIORITY||Hazard Ratio (HR)|0.58|||||TWO_SIDED|95.0|0.21|1.59|||Log Rank|||PD-L1 IC0||1.59|0.21|
72621753|NCT03726879|144773905|SUPERIORITY||Hazard Ratio (HR)|2.38|||||TWO_SIDED|95.0|0.22|26.42|||Regression, Cox|||PIK3CA-Missing||26.42|0.22|
72621754|NCT03726879|144773905|SUPERIORITY||Hazard Ratio (HR)|0.66|||||TWO_SIDED|95.0|0.23|1.9|||Regression, Cox|||PIK3CA-Mutated||1.90|0.23|
72621755|NCT03726879|144773905|SUPERIORITY||Hazard Ratio (HR)|0.91|||||TWO_SIDED|95.0|0.45|1.87|||Regression, Cox|||PIK3CA-Wildtype||1.87|0.45|
72621756|NCT03726879|144773906|SUPERIORITY||Hazard Ratio (HR)|1.17|||||TWO_SIDED|95.0|0.07|18.91|||Regression, Cox|||PIK3CA-Missing||18.91|0.07|
72621757|NCT03726879|144773906|SUPERIORITY||Hazard Ratio (HR)|0.61|||||TWO_SIDED|95.0|0.19|1.92||||||PIK3CA-Mutated||1.92|0.19|
72621758|NCT03726879|144773906|SUPERIORITY||Hazard Ratio (HR)|0.72|||||TWO_SIDED|95.0|0.33|1.55|||Regression, Cox|||PIK3CA-Wildtype||1.55|0.33|
72621759|NCT03726879|144773907|SUPERIORITY||Hazard Ratio (HR)|999.99|||||TWO_SIDED|95.0|0.0||Upper limit of the CI was not evaluable due to low number of events||Regression, Cox||The estimated value is \>999.99|PIK3CA-Missing|||0.00|
72621760|NCT03726879|144773907|SUPERIORITY||Hazard Ratio (HR)|0.59|||||TWO_SIDED|95.0|0.1|3.53|||Regression, Cox|||PIK3CA-Mutated||3.53|0.10|
72621761|NCT03726879|144773907|SUPERIORITY||Hazard Ratio (HR)|0.82|||||TWO_SIDED|95.0|0.33|2.09|||Regression, Cox|||PIK3CA-Wildtype||2.09|0.33|
72466712|NCT03121612|144456826|SUPERIORITY|||||||1||||||Not adjusted for multiple comparisons.|Fisher Exact|No failures in older stratum, so stratification by gestational age-group not controlled for in analysis.||||||1.0
72466713|NCT03121612|144456827|SUPERIORITY|||||||0.33||||||Not adjusted for multiple comparisons|Cochran-Mantel-Haenszel|Controlling for stratification by gestational group.||||||0.33
72466714|NCT03121612|144456828|SUPERIORITY|||||||0.31||||||Not adjusted for multiple comparisons|Cochran-Mantel-Haenszel|Controlling for stratification by gestational age-group.||||||0.31
72466715|NCT03121612|144456829|SUPERIORITY|||||||0.81||||||Not adjusted for multiple comparisons.|van Elteren's extension to Wilcoxon|van Elteren's extension used to control for stratification by gestation||||||0.81
72466716|NCT03121612|144456830|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.0
72466717|NCT03121612|144456836|SUPERIORITY|||||||1||||||No adjustment for multiple comparisons.|Fisher Exact|No failures in older stratum, so stratification by gestational age-group not controlled for in analysis.||||||1.0
72466718|NCT03121612|144456838|SUPERIORITY|||||||1|||||||Fisher Exact|No adjustment for multiple comparisons||||||1.0
72466719|NCT01841112|144456850|SUPERIORITY_OR_OTHER_LEGACY||Slope|1.3712|||||TWO_SIDED|95.0|0.7272|2.0151|||||The standard error of slope estimate = 0.3038.|Dose proportionality was assessed in Chinese subjects. For the power model perfect dose proportionality would correspond to a slope of 1.||2.0151|0.7272|
72466720|NCT01841112|144456850|SUPERIORITY_OR_OTHER_LEGACY||Slope|1.3652|||||TWO_SIDED|95.0|1.0421|1.6883|||||The standard error of slope estimate = 0.1516.|Dose proportionality was assessed in Japanese subjects. For the power model perfect dose proportionality would correspond to a slope of 1.||1.6883|1.0421|
72466721|NCT01841112|144456851|SUPERIORITY_OR_OTHER_LEGACY||Slope|1.1998|||||TWO_SIDED|95.0|0.4794|1.9202|||||The standard error of slope estimate = 0.3380.|Dose proportionality was assessed in Chinese subjects. For the power model perfect dose proportionality would correspond to a slope of 1.||1.9202|0.4794|
72466722|NCT01841112|144456851|SUPERIORITY_OR_OTHER_LEGACY||Slope|1.0299|||||TWO_SIDED|95.0|0.7131|1.3466|||||The standard error of slope estimate = 0.1486.|Dose proportionality was assessed in Japanese subjects. For the power model perfect dose proportionality would correspond to a slope of 1.||1.3466|0.7131|
72466723|NCT01841112|144456852|SUPERIORITY_OR_OTHER_LEGACY||Slope|1.2015|||||TWO_SIDED|95.0|0.5078|1.8952|||||The standard error of slope estimate = 0.3272.|Dose proportionality was assessed in Chinese subjects. For the power model perfect dose proportionality would correspond to a slope of 1.||1.8952|0.5078|
72466724|NCT01841112|144456852|SUPERIORITY_OR_OTHER_LEGACY||Slope|1.0301|||||TWO_SIDED|95.0|0.7133|1.3469|||||The standard error of slope estimate = 0.1486.|Dose proportionality was assessed in Japanese subjects. For the power model perfect dose proportionality would correspond to a slope of 1.||1.3469|0.7133|
72466725|NCT00878553|144456859|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-8.606|STANDARD_ERROR_OF_MEAN|2.42||0.0118|TWO_SIDED|95.0|-15.284|-1.927||Change from baseline in mean WASO3-7 compared values for the 20-mg dose vs. placebo. If that comparison demonstrated superiority of the 20-mg dose, then results for the 15-mg dose vs. placebo were compared; if significant, then 10-mg vs. placebo|Mixed Models Analysis|This hierarchical, 2-sided testing procedure maintained the overall level of significance at approximately 0.05|Adjusted mean differences were analyzed via general linear model that used change from baseline as response variable and included effects for patient, period, sequence, and treatment. A negative mean change from baseline indicates an improvement.|Literature-based estimates of WASO (Wake After Sleep Onset) SD (Standard Deviation) range from 39 to 45 minutes. Null hypothesis: difference between mean WASO3-7 values for placebo and the 15-mg SKP-1041 dose level equals 0. By using a 2-sided, 1-sample t test at the 5% level of significance of this null hypothesis and an assumed SD of 45 minutes, a sample size of 54 completed patients was calculated to provide 90% power to detect a mean treatment difference of 20 minutes||-1.927|-15.284|0.0118
72466726|NCT00878553|144456859|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-9.98|STANDARD_ERROR_OF_MEAN|2.421||0.0037|TWO_SIDED|95.0|-16.685|-3.275||Change from baseline in mean WASO3-7 compared values for the 20-mg dose vs. placebo. If that comparison demonstrated superiority of the 20-mg dose, then results for the 15-mg dose vs. placebo were compared; if significant, then 10-mg vs. placebo|Mixed Models Analysis|This hierarchical, 2-sided testing procedure maintained the overall level of significance at approximately 0.05|Adjusted mean differences were analyzed via general linear model that used change from baseline as response variable and included effects for patient, period, sequence, and treatment. A negative mean change from baseline indicates an improvement|Literature-based estimates of WASO SD range from 39 to 45 minutes. Null hypothesis: difference between mean WASO3-7 values for placebo and the 15-mg SKP-1041 dose level equals 0. By using a 2-sided, 1-sample t test at the 5% level of significance of this null hypothesis and an assumed SD of 45 minutes, a sample size of 54 completed patients was calculated to provide 90% power to detect a mean treatment difference of 20 minutes||-3.275|-16.685|0.0037
72621762|NCT03708770|144773926|OTHER|No power calculation was performed for this study.||||||||||||||||"This was not a hypothesis-driven study. Therefore, there were no primary effectiveness or safety endpoints.~The Secondary Patency endpoint was calculated using a Kaplan-Meier analysis."|The Secondary Patency rate was determined via Kaplan-Meier methods.|||
72466727|NCT00878553|144456859|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-9.153|STANDARD_ERROR_OF_MEAN|2.422||0.0077|TWO_SIDED|95.0|-15.857|-2.448||Change from baseline in mean WASO3-7 compared values for the 20-mg dose vs. placebo. If that comparison demonstrated superiority of the 20-mg dose, then results for the 15-mg dose vs. placebo were compared; if significant, then 10-mg vs. placebo.|Mixed Models Analysis|This hierarchical, 2-sided testing procedure maintained the overall level of significance at approximately 0.05.|Adjusted mean differences were analyzed via general linear model that used change from baseline as response variable and included effects for patient, period, sequence, and treatment. A negative mean change from baseline indicates an improvement|Literature-based estimates of WASO SD range from 39 to 45 minutes. Null hypothesis: difference between mean WASO3-7 values for placebo and the 20-mg SKP-1041 dose level equals 0. By using a 2-sided, 1-sample t test at the 5% level of significance of this null hypothesis and an assumed SD of 45 minutes, a sample size of 54 completed patients was calculated to provide 90% power to detect a mean treatment difference of 20 minutes.||-2.448|-15.857|0.0077
72466728|NCT00878553|144456860|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.604|STANDARD_ERROR_OF_MEAN|2.755||0.1476|TWO_SIDED|95.0|-13.208|2.0||Adjusted mean differences were analyzed via general linear model that used change from baseline as response variable and included effects for patient, period, sequence, and treatment.|Mixed Models Analysis|No adjustment for multiple testing was made for secondary efficacy endpoints.|A negative mean change from baseline indicates an improvement.|Literature-based estimates of WASO (Wake After Sleep Onset) SD (Standard Deviation) range from 39 to 45 minutes. Null hypothesis: difference between mean WASO3-7 values for placebo and the 15-mg SKP-1041 dose level equals 0. By using a 2-sided, 1-sample t test at the 5% level of significance of this null hypothesis and an assumed SD of 45 minutes, a sample size of 54 completed patients was calculated to provide 90% power to detect a mean treatment difference of 20 minutes.||2.000|-13.208|0.1476
72466729|NCT00878553|144456860|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-6.912|STANDARD_ERROR_OF_MEAN|2.757||0.0757|TWO_SIDED|95.0|-14.546|0.722||Adjusted mean differences were analyzed via general linear model that used change from baseline as response variable and included effects for patient, period, sequence, and treatment.|Mixed Models Analysis|No adjustment for multiple testing was made for secondary efficacy endpoints.|A negative mean change from baseline indicates an improvement.|Literature-based estimates of WASO (Wake After Sleep Onset) SD (Standard Deviation) range from 39 to 45 minutes. Null hypothesis: difference between mean WASO3-7 values for placebo and the 15-mg SKP-1041 dose level equals 0. By using a 2-sided, 1-sample t test at the 5% level of significance of this null hypothesis and an assumed SD of 45 minutes, a sample size of 54 completed patients was calculated to provide 90% power to detect a mean treatment difference of 20 minutes.||0.722|-14.546|0.0757
72466730|NCT00878553|144456860|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.521|STANDARD_ERROR_OF_MEAN|2.757||0.1553|TWO_SIDED|95.0|-13.154|2.113||Adjusted mean differences were analyzed via general linear model that used change from baseline as response variable and included effects for patient, period, sequence, and treatment.|Mixed Models Analysis|No adjustment for multiple testing was made for secondary efficacy endpoints.|A negative mean change from baseline indicates an improvement.|Literature-based estimates of WASO (Wake After Sleep Onset) SD (Standard Deviation) range from 39 to 45 minutes. Null hypothesis: difference between mean WASO3-7 values for placebo and the 15-mg SKP-1041 dose level equals 0. By using a 2-sided, 1-sample t test at the 5% level of significance of this null hypothesis and an assumed SD of 45 minutes, a sample size of 54 completed patients was calculated to provide 90% power to detect a mean treatment difference of 20 minutes.||2.113|-13.154|0.1553
72466731|NCT00878553|144456861|SUPERIORITY_OR_OTHER||Mean Difference (Net)|8.831|STANDARD_ERROR_OF_MEAN|2.4||0.0092|TWO_SIDED|95.0|2.208|15.454||All aspects of the study's primary endpoint were statistically significant, and no adjustment for multiple testing was made for secondary efficacy endpoints.|Mixed Models Analysis||A positive mean difference from baseline indicates an improvement.|The adjusted mean differences were analyzed by using a general linear model that used change from baseline as the response variable and included effects for patient, period, sequence, and treatment.||15.454|2.208|0.0092
72503549|NCT02517515|144538059|SUPERIORITY|The superiority of the rate of sustained virologic response at 12 weeks after treatment (SVR12) for the treatment-naïve participants in the Double-blind 3-DAA group as compared with the historical rate for treatment-naïve patients treated with TVR + pegIFN + RBV was analyzed; the lower confidence bound of the 2-sided 95% confidence interval (95% CI) for the percentage of participants with SVR12 must exceed 84% to achieve superiority.|percentage of participants|99.5|||||TWO_SIDED|95.0|97.0|99.9||||||Based on a 2-sided significance level of 0.05 and an underlying rate of 96% for the Double-blind 3-DAA treatment-naïve group, the sample size 180 treatment-naïve participants provided \>90% power to demonstrate superiority of the regimen to the historical rate for treatment-naïve patients treated with TVR + pegIFN + RBV (80%) (based on one-sample chi-square test of a single binomial proportion for superiority).||99.9|97.0|
72503550|NCT02517515|144538059|SUPERIORITY|The superiority of the rate of sustained virologic response at 12 weeks after treatment for the treatment-experienced participants in the Double-blind 3-DAA group as compared with the historical rate for treatment-experienced patients treated with TVR + pegIFN + RBV was analyzed; the lower confidence bound of the 2-sided 95% CI for the percentage of participants with sustained virologic response at 12 weeks after treatment must exceed 75% to achieve superiority.|percentage of participants|100.0|||||TWO_SIDED|95.0|97.4|100.0||||||Based on a 2-sided significance level of 0.05 and an underlying rate of 96% for the Double-blind 3-DAA treatment-experienced group, the sample size 180 treatment-experienced participants provided \>90% power to demonstrate superiority of the regimen to the historical rate for treatment-experienced patients treated with TVR + pegIFN + RBV (80%) (based on one-sample chi-square test of a single binomial proportion for superiority).||100.0|97.4|
72466732|NCT00878553|144456861|SUPERIORITY_OR_OTHER||Mean Difference (Net)|10.425|STANDARD_ERROR_OF_MEAN|2.402||0.0023|TWO_SIDED|95.0|3.775|17.075||All aspects of the study's primary endpoint were statistically significant, and no adjustment for multiple testing was made for secondary efficacy endpoints.|Mixed Models Analysis||A positive mean difference from baseline indicates an improvement.|The adjusted mean differences were analyzed by using a general linear model that used change from baseline as the response variable and included effects for patient, period, sequence, and treatment.||17.075|3.775|0.0023
72466733|NCT00878553|144456861|SUPERIORITY_OR_OTHER||Mean Difference (Net)|10.147|STANDARD_ERROR_OF_MEAN|2.402||0.003|TWO_SIDED|95.0|3.498|16.796||All aspects of the study's primary endpoint were statistically significant, and no adjustment for multiple testing was made for secondary efficacy endpoints.|Mixed Models Analysis||A positive mean difference from baseline indicates an improvement.|The adjusted mean differences were analyzed by using a general linear model that used change from baseline as the response variable and included effects for patient, period, sequence, and treatment.||16.796|3.498|0.0030
72466734|NCT00878553|144456862|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.562|STANDARD_ERROR_OF_MEAN|0.244||0.1005|TWO_SIDED|95.0|-1.235|0.11||Adjusted mean differences were analyzed with a general linear model that used change from baseline as the response variable and included effects for patient, period,sequence, and treatment.|Mixed Models Analysis|No adjustment for multiple testing was made for secondary efficacy endpoints.|A negative mean change from baseline indicates an improvement.|This endpoint summarizes the number of times during Hours 3 7, after onset of persistent sleep, that there was a wake entry of at least 2 epochs duration. To be counted, each entry must have been separated by a sleep stage of 2, 3 4, or rapid eye movement.||0.110|-1.235|0.1005
72504843|NCT00035815|144540603|SUPERIORITY_OR_OTHER|||||||0.321||95.0|||||Wilcoxon (Mann-Whitney)|||The final secondary outcome measure was the rate of change in the ALSFRS-r score. The ALSFRS-r was completed at each visit (randomization and then at 3, 6, 12, 18 and 24 months post-randomization). As with the MMT scores a score of 0 was imputed on the day of death. Analysis of the ALSFRS-r scores as a secondary outcome was performed in similar manner as MMT score.||||0.321
72564651|NCT03346070|144660817|SUPERIORITY||Difference in percentage|-2.5||||0.335|TWO_SIDED|95.0|-13.6|7.1|||Miettinen & Nurminen method|||||7.1|-13.6|0.335
72564652|NCT03346070|144660817|SUPERIORITY||Difference in percentage|0.3||||0.935|TWO_SIDED|95.0|-11.1|11.9|||Miettinen & Nurminen method|||||11.9|-11.1|0.935
72564653|NCT03346070|144660817|SUPERIORITY||Difference in percentage|-2.7||||0.326|TWO_SIDED|95.0|-13.8|7.3|||Miettinen & Nurminen method|||||7.3|-13.8|0.326
72466735|NCT00878553|144456862|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.037|STANDARD_ERROR_OF_MEAN|0.244||0.0028|TWO_SIDED|95.0|-1.712|-0.362||Adjusted mean differences were analyzed with a general linear model that used change from baseline as the response variable and included effects for patient, period,sequence, and treatment.|Mixed Models Analysis|No adjustment for multiple testing was made for secondary endpoints.|A negative mean change from baseline indicates an improvement.|This endpoint summarizes the number of times during Hours 3 7, after onset of persistent sleep, that there was a wake entry of at least 2 epochs duration. To be counted, each entry must have been separated by a sleep stage of 2, 3 4, or rapid eye movement.||-0.362|-1.712|0.0028
72466736|NCT00878553|144456862|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.793|STANDARD_ERROR_OF_MEAN|0.244||0.0216|TWO_SIDED|95.0|-1.467|-0.118||Adjusted mean differences were analyzed with a general linear model that used change from baseline as the response variable and included effects for patient, period,sequence, and treatment.|Mixed Models Analysis|No adjustments for multiple testing were made for secondary efficacy endpoints.|A negative mean change from baseline indicates an improvement.|This endpoint summarizes the number of times during Hours 3 7, after onset of persistent sleep, that there was a wake entry of at least 2 epochs duration. To be counted, each entry must have been separated by a sleep stage of 2, 3 4, or rapid eye movement.||-0.118|-1.467|0.0216
72466737|NCT00878553|144456863|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-8.452|STANDARD_ERROR_OF_MEAN|0.219||0.219|TWO_SIDED|95.0|-21.98|5.077||Mean (SEM) = adjusted mean change from baseline in each group (and standard error of the mean) and P value = P value for the comparison of the SEM of the active group with that of the placebo group.|Mixed Models Analysis|No adjustment for multiple testing was made for secondary efficacy endpoints.|A negative mean change from baseline indicates an improvement.|Study was powered on the primary endpoint. Data for sWASO were sourced from Question 5 of the Morning Sleep Questionnaire. Its analysis follows a general linear model change from baseline as response variable including effects for patient, period, sequence, and treatment.||5.077|-21.980|0.2190
72466738|NCT00878553|144456863|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.365|STANDARD_ERROR_OF_MEAN|4.937||0.8441|TWO_SIDED|95.0|-12.327|15.056||Mean (SEM) = adjusted mean change from baseline in each group (and standard error of the mean) and P value = P value for the comparison of the SEM of the active group with that of the placebo group.|Mixed Models Analysis|No adjustment for multiple testing was made for secondary efficacy endpoints.|A positive mean change from baseline indicates a worsening.|Study was powered on the primary endpoint. Data for sWASO were sourced from Question 5 of the Morning Sleep Questionnaire. Its analysis follows a general linear model change from baseline as response variable including effects for patient, period, sequence, and treatment.||15.056|-12.327|0.8441
72466739|NCT00878553|144456863|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-11.84|STANDARD_ERROR_OF_MEAN|4.936||0.0894|TWO_SIDED|95.0|-25.522|1.842||Mean (SEM) = adjusted mean change from baseline in each group (and standard error of the mean) and P value = P value for the comparison of the SEM of the active group with that of the placebo group.|Mixed Models Analysis|No adjustment for multiple testing was made for secondary efficacy endpoints.|A negative mean change from baseline indicates an improvement.|Study was powered on the primary endpoint. Data for sWASO were sourced from Question 5 of the Morning Sleep Questionnaire. Its analysis follows a general linear model change from baseline as response variable including effects for patient, period, sequence, and treatment.||1.842|-25.522|0.0894
72503551|NCT02517515|144538060|SUPERIORITY|The superiority of the rate of sustained virologic response at 24 weeks after treatment (SVR24) for the treatment-naïve participants in the Double-blind 3-DAA group as compared with the historical rate for treatment-naïve patients treated with TVR + pegIFN + RBV was analyzed; the lower confidence bound of the 2-sided 95% confidence interval (95% CI) for the percentage of participants with SVR24 must exceed 84% to achieve superiority.|percentage of participants|99.5|||||TWO_SIDED|95.0|97.0|99.9||||||Based on a 2-sided significance level of 0.05 and an underlying rate of 96% for the Double-blind 3-DAA treatment-experienced group, the sample size 180 treatment-experienced participants provided \>90% power to demonstrate superiority of the regimen to the historical rate for treatment-experienced patients treated with TVR + pegIFN + RBV (80%) (based on one-sample chi-square test of a single binomial proportion for superiority).||99.9|97.0|
72503552|NCT02517515|144538060|SUPERIORITY|The superiority of the rate of sustained virologic response at 24 weeks after treatment (SVR24) for the treatment-experienced participants in the double-blind 3-DAA group as compared with the historical rate for treatment-experienced patients treated with TVR + pegIFN + RBV was analyzed; the lower confidence bound of the 2-sided 95% CI for the percentage of participants with SVR24 must exceed 75% to achieve superiority.|percentage of participants|100.0|||||TWO_SIDED|95.0|97.4|100.0||||||Based on a 2-sided significance level of 0.05 and an underlying rate of 96% for the Double-blind 3-DAA treatment-experienced group, the sample size 180 treatment-experienced participants provided \>90% power to demonstrate superiority of the regimen to the historical rate for treatment-experienced patients treated with TVR + pegIFN + RBV (80%) (based on one-sample chi-square test of a single binomial proportion for superiority).||100.0|97.4|
72503553|NCT02786537|144538068|SUPERIORITY|Superiority test derived by comparing whether the 95% CI includes zero.|Mean Difference (Net)|-1.7|||||TWO_SIDED|95.0|-3.6|0.3|||||CI for mean derived from PROC TTEST, difference in mean and its 95%CI was calculated by Satterthwaite method.|PROD vs. SOF/LDV based regimens as reported in PRO (ALL PATIENTS WHO STARTED TREATMENT BY ARM AS TREATED), population limited to as randomization date of the last PrOD patient start date - RBV FREE REGIMENS||0.3|-3.6|
72503554|NCT02786537|144538068|SUPERIORITY||Mean Difference (Net)|1.4|||||TWO_SIDED|95.0|-0.4|3.1|||||CI for mean derived from PROC TTEST, difference in mean and its 95%CI was calculated by Satterthwaite method. CI for median derived from PROC QUANTREG.|RBV free EBR/GZR regimen compared to PrOD in consideration that RBV usage was determined by provider and not study randomization.||3.1|-0.4|
72621763|NCT03708770|144773927|OTHER|No power calculation was performed for this study.||||||||||||||||"This was not a hypothesis-driven study. Therefore, there were no primary effectiveness or safety endpoints.~The Primary Patency endpoint was calculated using a Kaplan-Meier analysis."|The primary patency rate was determined via Kaplan-Meier methods.|||
72621764|NCT01197300|144773941|SUPERIORITY|Difference in least squares mean = LS mean for the Core treatment Zoledronic acid group - LS mean for the Core treatment Placebo group.|Difference in LS mean|3.7||||0.8505|TWO_SIDED|95.0|-37.242|44.642||An analysis of covariance (ANCOVA) model was performed with Core treatment, pooled centers, underlying condition treated with GCs and Core baseline lumbar spine BMD Z-score as explanatory variables and pooled centers as random effect.|ANCOVA|||Lumbar Spine BMD Z-score Change at Month 18||44.642|-37.242|0.8505
72503555|NCT02786537|144538069|SUPERIORITY|Superiority test completed by comparing whether the 95% CI includes zero.|Mean Difference (Net)|0.2|||||TWO_SIDED|95.0|-0.6|1.0|||||CI for mean derived from PROC TTEST, difference in mean and its 95%CI was calculated by Satterthwaite method.|Analysis based on RBV free EBR/GZR regimen vs SOF/LDV (all patients who started treatment by arm as treated)||1.0|-0.6|
72503556|NCT02786537|144538071|SUPERIORITY|Superiority test comparison based on whether the 95% CI includes zero|Mean Difference (Net)|0.5|||||TWO_SIDED|95.0|0.0|1.0|||||The comparisons between regimens can be viewed as superiority test, by comparing whether the 95% CI includes zero|Analysis of EBR/GZR vs. SOF/LDV irrespective of RBV usage in consideration that RBV usage was determined by provider and not study randomization.||1.0|0.0|
72503557|NCT02786537|144538072|SUPERIORITY|Superiority test comparison based on whether the 95% CI includes zero|Mean Difference (Net)|1.4|||||TWO_SIDED|95.0|-4.2|7.0|||||CI for mean derived from PROC TTEST, difference in mean and its 95%CI was calculated by Satterthwaite method|Analysis based on RBV free SOF/LDV vs. PrOD in consideration that RBV usage was determined by provider and not study randomization and limited RBV sample size.||7.0|-4.2|
72503558|NCT02786537|144538072|SUPERIORITY|Superiority test comparison based on whether the 95% CI includes zero.|Mean Difference (Net)|1.4|||||TWO_SIDED|95.0|-4.2|7.0|||||CI for mean derived from PROC TTEST, difference in mean and its 95%CI was calculated by Satterthwaite method.|RBV free PrOD vs. SOF/LDV regimens (all patients who started treatment by arm as treated, population is limited to as randomization date of the last PrOD patient start date)||7.0|-4.2|
72503559|NCT02786537|144538073|SUPERIORITY|Superiority test comparison based on whether the 95% CI includes zero|Mean Difference (Net)|-0.2|||||TWO_SIDED|95.0|-1.6|1.3|||||CI for mean derived from PROC TTEST, difference in mean and its 95%CI was calculated by Satterthwaite method.|RBV free EBR/GZR vs. SOF/LDV (all patients who started treatment by arm as treated)||1.3|-1.6|
72564654|NCT03346070|144660817|SUPERIORITY||Difference in percentage|-1.4||||0.299|TWO_SIDED|95.0|-7.5|3.5|||Miettinen & Nurminen method|||||3.5|-7.5|0.299
72466740|NCT00878553|144456864|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.56|STANDARD_ERROR_OF_MEAN|1.469||0.6433|TWO_SIDED|95.0|-1.823|2.943||Analysis included effects for patient, period, sequence and treatment.|Mixed Models Analysis||A positive mean difference from baseline indicates improvement.|Adjusted mean differences were analyzed by using a general linear model that used change from baseline as the response variable.||2.943|-1.823|0.6433
72466741|NCT00878553|144456864|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.912|STANDARD_ERROR_OF_MEAN|1.523||0.1167|TWO_SIDED|95.0|-4.304|0.481||Analysis included effects for patient, period, sequence and treatment|Mixed Models Analysis||A negative mean difference from baseline indicates a worsening.|Adjusted mean differences were analyzed by using a general linear model that used change from baseline as the response variable.||0.481|-4.304|0.1167
72466742|NCT00878553|144456864|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.434|STANDARD_ERROR_OF_MEAN|1.626||0.2385|TWO_SIDED|95.0|-0.958|3.826||Analysis included effects for patient, period, sequence and treatment.|Mixed Models Analysis||A positive mean difference from baseline indicates improvement.|Adjusted mean differences were analyzed by using a general linear model that used change from baseline as the response variable.||3.826|-0.958|0.2385
72466743|NCT00878553|144456865|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.45|STANDARD_ERROR_OF_MEAN|0.256||0.0914|TWO_SIDED|95.0|-0.073|0.972|||Mixed Models Analysis||A positive mean change from baseline indicates an improvement.|The adjusted mean differences were analyzed with a general linear model that used change from baseline as the response variable and included effects for patient, period, sequence and treatment.||0.972|-0.073|0.0914
72466744|NCT00878553|144456865|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.165|STANDARD_ERROR_OF_MEAN|0.259||0.536|TWO_SIDED|95.0|-0.36|0.69|||Mixed Models Analysis||A positive mean change from baseline indicates an improvement.|The adjusted mean differences were analyzed with a general linear model that used change from baseline as the response variable and included effects for patient, period, sequence and treatment.||0.690|-0.360|0.5360
72466745|NCT00878553|144456865|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.262|STANDARD_ERROR_OF_MEAN|0.237||0.3254|TWO_SIDED|95.0|-0.787|0.263|||Mixed Models Analysis||A negative mean change from baseline indicates a worsening.|The adjusted mean differences were analyzed with a general linear model that used change from baseline as the response variable and included effects for patient, period, sequence and treatment.||0.263|-0.787|0.3254
72503560|NCT02786537|144538076|SUPERIORITY|Superiority test based on whether the 95% CI includes zero|Mean Difference (Net)|1.8|||||TWO_SIDED|95.0|-1.9|5.5|||||CI for mean derived from PROC TTEST, difference in mean and its 95%CI was calculated by Satterthwaite method.|RBV free EBR/GZR vs. PrOD regimens as reported in PRO (all patients who started treatment by arm as treated, population is limited to as randomization date of the last PrOD patient start date). Analysis limited to RBV free regimen in consideration RBV usage determined by provider and not study randomization.||5.5|-1.9|
72503561|NCT02786537|144538076|SUPERIORITY|Superiority test based on whether the 95% CI includes zero|Mean Difference (Net)|-1.0|||||TWO_SIDED|95.0|-4.6|2.7|||||CI for mean derived from PROC TTEST, difference in mean and its 95%CI was calculated by Satterthwaite method.|RBV free SOF/LDV vs. PrOD regimens as reported in PRO (all patients who started treatment by arm as treated, population is limited to as randomization date of the last PrOD patient start date)||2.7|-4.6|
72564655|NCT03346070|144660818|SUPERIORITY||Difference in percentage|0.1|||||TWO_SIDED|95.0|-12.7|13.1|||||Miettinen and Nurminen method|||13.1|-12.7|
72564656|NCT03346070|144660818|SUPERIORITY||Difference in percentage|-3.6|||||TWO_SIDED|95.0|-19.6|12.2|||||Miettinen and Nurminen method|||12.2|-19.6|
72564657|NCT03346070|144660818|SUPERIORITY||Difference in percentage|5.1|||||TWO_SIDED|95.0|-8.1|19.7|||||Miettinen and Nurminen method|||19.7|-8.1|
72564658|NCT03346070|144660818|SUPERIORITY||Difference in percentage|-2.6|||||TWO_SIDED|95.0|-18.0|13.1|||||Miettinen and Nurminen method|||13.1|-18.0|
72466746|NCT00878553|144456866|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.71|STANDARD_ERROR_OF_MEAN|1.818||0.719|TWO_SIDED|95.0|-3.175|4.595||Adjusted mean differences were analyzed in a general linear model that used change from baseline as the response variable.|Mixed Models Analysis|The Model included effects for patient, period, sequence and treatment.|A positive mean change from baseline indicates improvement.|||4.595|-3.175|0.7190
72564659|NCT03346070|144660818|SUPERIORITY||Difference in percentage|4.4|||||TWO_SIDED|95.0|-9.6|19.2|||||Miettinen and Nurminen method|||19.2|-9.6|
72564660|NCT03346070|144660818|SUPERIORITY||Difference in percentage|2.2|||||TWO_SIDED|95.0|-12.5|17.0|||||Miettinen and Nurminen method|||17.0|-12.5|
72564661|NCT03346070|144660818|SUPERIORITY||Difference in percentage|-1.8|||||TWO_SIDED|95.0|-11.4|7.8|||||Miettinen and Nurminen method|||7.8|-11.4|
72503562|NCT02786537|144538077|SUPERIORITY|Superiority test comparison based on presence of zero in 95% CI.|Mean Difference (Net)|0.1|||||TWO_SIDED|95.0|-1.4|1.6|||||CI for mean derived from PROC TTEST, difference in mean and its 95%CI was calculated by Satterthwaite method|Analysis limited to RBV free regimens in consideration that RBV usage determined by provider and not study randomization. All patients who started treatment by arm as treated.||1.6|-1.4|
72503563|NCT02786537|144538080|SUPERIORITY|Superiority test determined by comparing presence of zero in CI.|Mean Difference (Net)|-4.3|||||TWO_SIDED|95.0|-9.9|1.3|||||CI for mean derived from PROC TTEST, difference in mean and its 95%CI was calculated by Satterthwaite method|Analysis based on RBV free regimens -all patients who started treatment by arm as treated, population is limited to as randomization date of the last PrOD patient start date.||1.3|-9.9|
72503564|NCT02786537|144538080|SUPERIORITY|Superiority comparison by viewing presence of zero in CI.|Mean Difference (Net)|3.0|||||TWO_SIDED|95.0|-3.4|9.4||||||RBV free regimens as reported in PRO (all patients who started treatment by arm as treated, population limited to as randomization date of the last PrOD patient start date)||9.4|-3.4|
72503565|NCT02786537|144538082|SUPERIORITY||Mean Difference (Net)|-0.7|||||TWO_SIDED|95.0|-3.6|2.1|||||CI for mean derived from PROC TTEST, difference in mean and its 95%CI was calculated by Satterthwaite method.|Analysis based on RBV free regimens in consideration that RBV usage was determined by provider and not study randomization. Population includes patients who started treatment by arm as treated.||2.1|-3.6|
72503566|NCT02786537|144538091|EQUIVALENCE|Pre-specified equivalence range +/-5%|Mean Difference (Net)|-2.3|||||TWO_SIDED|95.0|-15.3|11.3||||||||11.3|-15.3|
72503567|NCT00443560|144538097|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.3|||<|0.01||95.0|2.3|4.5|||Chi-squared, Corrected|||||4.5|2.3|<0.01
72503568|NCT00443560|144538098|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|12.2|||<|0.01||95.0|9.9|15.0|||Chi-squared, Corrected|||||15.0|9.9|<0.01
72503569|NCT00443560|144538099|SUPERIORITY_OR_OTHER||||||<|0.01||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.01
72503570|NCT05099991|144538100|NON_INFERIORITY|Non-inferiority would be demonstrated with a mean increase in procedure of 5 minutes.|Mean Difference (Final Values)|0.2|||||TWO_SIDED|95.0|-7.8|8.2||||||||8.2|-7.8|
72503571|NCT05099991|144538101|OTHER|||||||0.07|||||||Fisher Exact|||||||0.07
72503572|NCT01389128|144538103|OTHER||||||<|0.01|||||||Chi-squared|||||||<0.01
72564662|NCT03346070|144660819|SUPERIORITY||Difference in percentage|-2.6|||||TWO_SIDED|95.0|-15.2|9.1|||||Miettinen and Nurminen method|||9.1|-15.2|
72564663|NCT03346070|144660819|SUPERIORITY||Difference in percentage|-8.5|||||TWO_SIDED|95.0|-22.3|1.3|||||Miettinen and Nurminen method|||1.3|-22.3|
72503573|NCT01389128|144538106|OTHER|||||||0.68|||||||Chi-squared|||||||0.68
72503574|NCT00315302|144538131|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3|STANDARD_DEVIATION|0.24||0.21||95.0|-0.2|0.8|||ANCOVA||The difference was calculated as atropine plus plano group minus atropine group|"The primary analysis was a treatment group comparison of logMAR visual acuity scores in the amblyopic eye obtained 18 weeks after randomization, adjusted for baseline acuity scores in an analysis of covariance (ANCOVA) model.~The primary analysis included only patients with visual acuity of 20/40 to 20/100; sample size was based upon a two-sided alpha of 0.05, with 90% power to detect a difference if the true difference in change from baseline between groups was 0.075 logMAR at 18 weeks."||0.8|-0.2|0.21
72503575|NCT00315302|144538132|SUPERIORITY_OR_OTHER|||||||0.03||95.0|||||Regression, Logistic|proportion 20/25 as a function of treatment group controlling for baseline acuity||"Null hypothesis: proportion 20/25 or better at 18wks in atropine group = proportion 20/25 or better at 18wks in atropine plus plano group~Alternative hypothesis: proportion 20/25 or better at 18wks in atropine group NOT equal to proportion 20/25 or better at 18wks in atropine plus plano group"||||.03
72503576|NCT00315302|144538133|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.5|STANDARD_DEVIATION|3.1|||TWO_SIDED|95.0|3.2|5.8||||||95% confidence interval calculated within treatment group on the amount of change from baseline||5.8|3.2|
72503577|NCT00315302|144538133|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.1|STANDARD_DEVIATION|3.7|||TWO_SIDED|95.0|3.7|6.4||||||95% confidence interval calculated within treatment group on the amount of change from baseline||6.4|3.7|
72503578|NCT00315302|144538134|SUPERIORITY_OR_OTHER|||||||0.39||95.0|||||Regression, Logistic|proportion 20/25 as a function of treatment group controlling for baseline acuity||"Null hypothesis: proportion 3 or more lines better at 18wks in atropine group = proportion 3 or more lines better at 18wks in atropine plus plano group~Alternative hypothesis: proportion 3 or more lines better at 18wks in atropine group NOT equal to proportion 3 or more lines better at 18wks in atropine plus plano group"||||0.39
72503579|NCT00315302|144538135|SUPERIORITY_OR_OTHER|||||||0.39||95.0|||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test to evaluate difference in change from baseline in stereoacuity by treatment group||All patients without respect to cause of amblyopia.||||0.39
72503580|NCT00315302|144538136|SUPERIORITY_OR_OTHER|||||||0.9||95.0|||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test to evaluate difference in change from baseline in stereoacuity by treatment group||Among anisometropic patients only||||0.90
72564664|NCT03346070|144660819|SUPERIORITY||Difference in percentage|-5.3|||||TWO_SIDED|95.0|-18.8|6.8|||||Miettinen and Nurminen method|||6.8|-18.8|
72564665|NCT03346070|144660819|SUPERIORITY||Difference in percentage|-8.0|||||TWO_SIDED|95.0|-21.2|1.8|||||Miettinen and Nurminen method|||1.8|-21.2|
72564666|NCT03346070|144660819|SUPERIORITY||Difference in percentage|-2.9|||||TWO_SIDED|95.0|-17.0|10.5|||||Miettinen and Nurminen method|||10.5|-17.0|
72564667|NCT03346070|144660819|SUPERIORITY||Difference in percentage|0.5|||||TWO_SIDED|95.0|-14.0|15.5|||||Miettinen and Nurminen method|||15.5|-14.0|
72564668|NCT03346070|144660819|SUPERIORITY||Difference in percentage|-5.5|||||TWO_SIDED|95.0|-13.9|1.2|||||Miettinen and Nurminen method|||1.2|-13.9|
72564669|NCT03346070|144660820|SUPERIORITY||Difference in percentage|-2.4|||||TWO_SIDED|95.0|-13.4|7.3|||||Miettinen and Nurminen method|||7.3|-13.4|
72564670|NCT03346070|144660820|SUPERIORITY||Difference in percentage|-0.4|||||TWO_SIDED|95.0|-12.3|10.8|||||Miettinen and Nurminen method|||10.8|-12.3|
72466747|NCT00878553|144456866|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.821|STANDARD_ERROR_OF_MEAN|2.422||0.6784|TWO_SIDED|95.0|-3.08|4.722||Adjusted mean differences were analyzed in a general linear model that used change from baseline as the response variable.|Mixed Models Analysis|The Model included effects for patient, period, sequence and treatment.|A positive mean change from baseline indicates an improvement.|||4.722|-3.080|0.6784
72466748|NCT00878553|144456866|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.314|STANDARD_ERROR_OF_MEAN|2.058||0.2433|TWO_SIDED|95.0|-1.586|6.214||Adjusted mean differences were analyzed in a general linear model that used change from baseline as the response variable.|Mixed Models Analysis|The Model included effects for patient, period, sequence and treatment.|A positive mean change from baseline indicates an improvement.|||6.214|-1.586|0.2433
72466749|NCT00878553|144456867|SUPERIORITY_OR_OTHER||Mean Difference (Net)|8.39||||0.0009|TWO_SIDED||||||ANOVA|F-test 2 degrees of freedom||Cmax(ng/mL) \[Maximum plasma zaleplon concentration\]||||0.0009
72466750|NCT00878553|144456868|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.09||||0.9142||95.0|||||ANOVA|F-test two degrees of freedom||Cmax normalized per dose||||0.9142
72466751|NCT00878553|144456869|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.24||||0.1193||95.0|||||ANOVA|F-test 2 degrees of freedom||Time (hour)post-dose of maximum plasma zaleplon concentration||||0.1193
72466752|NCT00878553|144456870|SUPERIORITY_OR_OTHER||Mean Difference (Net)|9.85||||0.0003||95.0|||||ANOVA|F-test 2 degrees of freedom||AUC ng\*h/mL)||||0.0003
72466753|NCT00878553|144456871|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.28||||0.2281||95.0|||||ANOVA|F-test 2 degrees of freedom||AUC/Dose (ng\*h/mL/mg)||||0.2281
72503581|NCT00315302|144538138|SUPERIORITY_OR_OTHER|||||||0.003||95.0|||||Fisher Exact|||"Null hypothesis: proportion 1 or more lines worse and worse than 20/20 at 18wks same in both groups;~Alternate: proportion 1 or more lines worse and worse than 20/20 at 18wks same in both groups"||||0.003
72466754|NCT00878553|144456872|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.74||||0.4835||95.0|||||ANOVA|2 degrees of freedom F-test||Half-Life (t1/2 in hours) of plasma zaleplon from each of 3 doses of SKP-1041||||0.4835
72466755|NCT00461123|144456886|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.93||||0.5248||95.0|-4.18|8.05|||ANCOVA|Analysis of covariance (ANCOVA), baseline as covariate, treatment as fixed factor|Difference of least squares (LS) means (Placebo minus Vardenafil)|null hypothesis: mean of Vardenafil group equals mean of Placebo group at day +90||8.05|-4.18|0.5248
72466756|NCT00461123|144456887|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.27||||0.87||95.0|-3.58|3.04|||ANCOVA|Analysis of covariance (ANCOVA), baseline as covariate, treatment as fixed factor|Difference of LS means (Placebo minus Vardenafil)|null hypothesis: mean of Vardenafil group equals mean of Placebo group at day +90||3.04|-3.58|0.8700
72466757|NCT00461123|144456888|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.57||||0.4162||95.0|-8.21|19.35|||ANCOVA|Analysis of covariance (ANCOVA), baseline as covariate, treatment as fixed factor|Difference of LS means (Placebo minus Vardenafil)|null hypothesis: mean of Vardenafil group equals mean of Placebo group at day +90||19.35|-8.21|0.4162
72466758|NCT00461123|144456889|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.5||||0.0588||95.0|-13.25|0.26|||ANCOVA|Analysis of covariance (ANCOVA), baseline as covariate, treatment as fixed factor|Difference of LS means (Placebo minus Vardenafil)|null hypothesis: mean of Vardenafil group equals mean of Placebo group at day +90||0.26|-13.25|0.0588
72466759|NCT00461123|144456890|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.61||||0.7878||95.0|-22.03|16.82|||ANCOVA|Analysis of variance (ANOVA), treatment as fixed factor|Difference of LS means (Placebo minus Vardenafil)|null hypothesis: mean of Vardenafil group equals mean of Placebo group||16.82|-22.03|0.7878
72466760|NCT03029819|144456897|SUPERIORITY|||||||0.52|||||||Chi-squared|||||||.52
72466761|NCT03605368|144456920|EQUIVALENCE|Simple linear models ('lm' in R) were conducted. Statistical significance was set at p\<.05.|Mean Difference (Final Values)|0.16|STANDARD_ERROR_OF_MEAN|0.13||0.23|TWO_SIDED||||||Regression, Linear|||Overall Behavior. Change-from-baseline analyses were conducted (post-intervention assessment ratings minus pre-intervention assessment ratings) and compared between intervention groups (Floreo and BeSAFE).||||.23
72466762|NCT03605368|144456920|EQUIVALENCE|Simple linear models ('lm' in R) were conducted. Statistical significance was set at p\<.05.|Mean Difference (Final Values)|0.17|STANDARD_ERROR_OF_MEAN|0.09||0.07|TWO_SIDED||||||Regression, Linear|||Appropriate Response. Change-from-baseline analyses were conducted (post-intervention assessment ratings minus pre-intervention assessment ratings) and compared between intervention groups (Floreo and BeSAFE).||||.07
72503582|NCT00440401|144538146|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Cochran-Mantel-Haenszel|Normal approximation to the binominal distribution is used to construct the asymptotic confidence intervals||||||<0.0001
72466763|NCT03605368|144456920|EQUIVALENCE|Simple linear models ('lm' in R) were conducted. Statistical significance was set at p\<.05.|Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.17||0.99|TWO_SIDED||||||Regression, Linear|||Orienting. Change-from-baseline analyses were conducted (post-intervention assessment ratings minus pre-intervention assessment ratings) and compared between intervention groups (Floreo and BeSAFE).||||.99
72466764|NCT03605368|144456920|EQUIVALENCE|Simple linear models ('lm' in R) were conducted. Statistical significance was set at p\<.05.|Mean Difference (Final Values)|0.47|STANDARD_ERROR_OF_MEAN|0.16||0.005|TWO_SIDED||||||Regression, Linear|||Fidget. Change-from-baseline analyses were conducted (post-intervention assessment ratings minus pre-intervention assessment ratings) and compared between intervention groups (Floreo and BeSAFE).||||.005
72466765|NCT03605368|144456920|EQUIVALENCE|Simple linear models ('lm' in R) were conducted. Statistical significance was set at p\<.05.|Mean Difference (Final Values)|0.3|STANDARD_ERROR_OF_MEAN|0.11||0.01|TWO_SIDED||||||Regression, Linear|||Overall Behavior. Change-from-baseline analyses were conducted (post-intervention assessment ratings minus pre-intervention assessment ratings) and compared between intervention groups (Floreo and TAU).||||.01
72503583|NCT00440401|144538147|SUPERIORITY_OR_OTHER||||||<|0.0006||95.0|||||Cochran-Mantel-Haenszel|Normal approximation to the binominal distribution is used to construct the asymptotic confidence intervals||||||<0.0006
72564671|NCT03346070|144660820|SUPERIORITY||Difference in percentage|-2.6|||||TWO_SIDED|95.0|-13.7|7.0|||||Miettinen and Nurminen method|||7.0|-13.7|
72564672|NCT03346070|144660820|SUPERIORITY||Difference in percentage|0.2|||||TWO_SIDED|95.0|-11.2|11.7|||||Miettinen and Nurminen method|||11.7|-11.2|
72564673|NCT03346070|144660820|SUPERIORITY||Difference in percentage|-0.2|||||TWO_SIDED|95.0|-11.5|11.0|||||Miettinen and Nurminen method|||11.0|-11.5|
72564674|NCT03346070|144660820|SUPERIORITY||Difference in percentage|0.2|||||TWO_SIDED|95.0|-11.0|12.0|||||Miettinen and Nurminen method|||12.0|-11.0|
72564675|NCT03346070|144660821|SUPERIORITY||Difference in percentage|3.0|||||TWO_SIDED|95.0|-10.8|16.9|||||Miettinen and Nurminen method|||16.9|-10.8|
72564676|NCT03346070|144660821|SUPERIORITY||Difference in percentage|-76.1|||||TWO_SIDED|95.0|-87.2|-57.6|||||Miettinen and Nurminen method|||-57.6|-87.2|
72564677|NCT03346070|144660821|SUPERIORITY||Difference in percentage|-78.7|||||TWO_SIDED|95.0|-88.8|-61.1|||||Miettinen and Nurminen method|||-61.1|-88.8|
72564678|NCT03346070|144660821|SUPERIORITY||Difference in percentage|2.8|||||TWO_SIDED|95.0|-7.2|14.2|||||Miettinen and Nurminen method|||14.2|-7.2|
72564679|NCT03346070|144660821|SUPERIORITY||Difference in percentage|2.9|||||TWO_SIDED|95.0|-4.8|11.0|||||Miettinen and Nurminen method|||11.0|-4.8|
72564680|NCT03346070|144660822|SUPERIORITY||Ratio of geometric means|0.64|||||TWO_SIDED|95.0|0.48|0.86|||||Log transformation and t-distribution|||0.86|0.48|
72564681|NCT03346070|144660822|SUPERIORITY||Ratio of geometric means|0.09|||||TWO_SIDED|95.0|0.06|0.12|||||Log transformation and t-distribution|||0.12|0.06|
72564682|NCT03346070|144660822|SUPERIORITY||Ratio of geometric means|0.14|||||TWO_SIDED|95.0|0.1|0.19|||||Log transformation and t-distribution|||0.19|0.10|
72621765|NCT01197300|144773941|SUPERIORITY|Difference in least squares mean = LS mean for the Core treatment Zoledronic acid group - LS mean for the Core treatment Placebo group.|Difference in LS mean|21.752||||0.218|TWO_SIDED|95.0|-14.126|57.63||An analysis of covariance (ANCOVA) model was performed with Core treatment, pooled centers, underlying condition treated with GCs and Core baseline lumbar spine BMD Z-score as explanatory variables and pooled centers as random effect.|ANCOVA|||Lumbar Spine BMD Z-score Change at Month 24||57.630|-14.126|0.2180
72564683|NCT03346070|144660822|SUPERIORITY||Ratio of geometric means|0.54|||||TWO_SIDED|95.0|0.4|0.71|||||Log transformation and t-distribution|||0.71|0.40|
72564684|NCT03346070|144660822|SUPERIORITY||Ratio of geometric means|0.59|||||TWO_SIDED|95.0|0.48|0.72|||||Log transformation and t-distribution|||0.72|0.48|
72564685|NCT03346070|144660823|SUPERIORITY||Ratio of geometric means|0.63|||||TWO_SIDED|95.0|0.5|0.8|||||Log transformation and t-distribution|||0.80|0.50|
72564686|NCT03346070|144660823|SUPERIORITY||Ratio of geometric means|0.09|||||TWO_SIDED|95.0|0.07|0.13|||||Log transformation and t-distribution|||0.13|0.07|
72564687|NCT03346070|144660823|SUPERIORITY||Ratio of geometric means|0.15|||||TWO_SIDED|95.0|0.11|0.2|||||Log transformation and t-distribution|||0.20|0.11|
72564688|NCT03346070|144660823|SUPERIORITY||Ratio of geometric means|0.56|||||TWO_SIDED|95.0|0.44|0.72|||||Log transformation and t-distribution|||0.72|0.44|
72564689|NCT03346070|144660823|SUPERIORITY||Ratio of geometric means|0.6|||||TWO_SIDED|95.0|0.51|0.7|||||Log transformation and t-distribution|||0.70|0.51|
72564690|NCT03346070|144660824|SUPERIORITY||Ratio of geometric means|0.66|||||TWO_SIDED|95.0|0.54|0.81|||||Log transformation and t-distribution|||0.81|0.54|
72564691|NCT03346070|144660824|SUPERIORITY||Ratio of geometric means|0.13|||||TWO_SIDED|95.0|0.09|0.17|||||Log transformation and t-distribution|||0.17|0.09|
72564692|NCT03346070|144660824|SUPERIORITY||Ratio of geometric means|0.19|||||TWO_SIDED|95.0|0.14|0.27|||||Log transformation and t-distribution|||0.27|0.14|
72564693|NCT03346070|144660824|SUPERIORITY||Ratio of geometric means|0.66|||||TWO_SIDED|95.0|0.52|0.83|||||Log transformation and t-distribution|||0.83|0.52|
72564694|NCT03346070|144660824|SUPERIORITY||Ratio of geometric means|0.66|||||TWO_SIDED|95.0|0.57|0.77|||||Log transformation and t-distribution|||0.77|0.57|
72564695|NCT02551679|144660832|SUPERIORITY||Cox Proportional Hazard|2.046||||0.258|TWO_SIDED|95.0|0.577|7.255|||ANCOVA|||The primary hypothesis of this study is that ACP-01 is superior to placebo in terms of the earlier time from treatment with Investigational Medicinal Product (IMP) to either de-novo gangrene, or doubling of wound size, or major amputation, or death.||7.255|0.577|0.258
72564696|NCT03919448|144660851|EQUIVALENCE|The comparable bioavailability was achieved if 90 % confidence intervals (CIs) for the test-to-reference ratios of the geometric means of Cmax, Area Under the Serum Concentration-time Curve of Bevacizumab (ABC0-t) fell within the 80.00-125.00 % acceptance criteria.|Hazard Ratio (HR)|101.55||||0.9766|TWO_SIDED|90.0|90.19|114.34||Power of ANOVA: 0,93|ANOVA|||The null hypothesis (H0) of ANOVA is that there is no difference among group means. The alternate hypothesis (H1) is that at least one group differs significantly from the overall mean of the dependent variable.||114.34|90.19|0.9766
72564697|NCT03919448|144660851|EQUIVALENCE|The comparable bioavailability was achieved if 90 % confidence intervals (CIs) for the test-to-reference ratios of the geometric means of Cmax, Area Under the Serum Concentration-time Curve of Bevacizumab (ABC0-t) fell within the 80.00-125.00 % acceptance criteria.|Hazard Ratio (HR)|100.95||||0.9766|TWO_SIDED|90.0|89.75|113.55||Power of ANOVA: 0,93|ANOVA|||The null hypothesis (H0) of ANOVA is that there is no difference among group means. The alternate hypothesis (H1) is that at least one group differs significantly from the overall mean of the dependent variable.||113.55|89.75|0.9766
72564698|NCT03919448|144660851|EQUIVALENCE|As supplementary information, Test Product 1 vs. Test Product 2 shall also be compared. The comparable bioavailability was achieved if 90 % confidence intervals (CIs) for the test1-to-test2 ratios of the geometric means of Cmax, Area Under the Serum Concentration-time Curve of Bevacizumab (ABC0-t) fell within the 80.00-125.00 % acceptance criteria.|Hazard Ratio (HR)|100.59||||0.9766|TWO_SIDED|90.0|88.16|114.77|||ANOVA|||The null hypothesis (H0) of ANOVA is that there is no difference among group means. The alternate hypothesis (H1) is that at least one group differs significantly from the overall mean of the dependent variable.||114.77|88.16|0.9766
72503584|NCT05370157|144538157|SUPERIORITY||Mean Difference (Net)|4.25|STANDARD_ERROR_OF_MEAN|0.85||0.03|TWO_SIDED|95.0|0.76|7.74|||Regression, Linear|Satterthwaite Approximation||Intent-to-treat analyses tested changes in knowledge from baseline to follow-up using linear mixed models. Mixed models analyses were conducted in R using the lme4 package and restricted maximum likelihood estimation (REML). Models included fixed effects of time (baseline vs. follow-up), intervention condition, and their interaction as well as random effects for person and team. We used the clubSandwich package to calculate cluster robust standard errors.||7.74|0.76|.03
72503585|NCT05370157|144538158|SUPERIORITY||Mean Difference (Net)|-0.1|STANDARD_ERROR_OF_MEAN|0.08||0.3|TWO_SIDED|95.0|-0.4|0.2|||Regression, Linear|Satterthwaite Approximation||Intent-to-treat analyses tested changes in skill use from baseline to follow-up using linear mixed models. Mixed models analyses were conducted in R using the lme4 package and restricted maximum likelihood estimation (REML). Models included fixed effects of time (baseline vs. follow-up), intervention condition, and their interaction as well as random effects for person and team. We used the clubSandwich package to calculate cluster robust standard errors.||0.20|-0.40|.30
72503586|NCT05370157|144538162|SUPERIORITY||Mean Difference (Net)|-0.23|STANDARD_ERROR_OF_MEAN|0.25||0.45|TWO_SIDED|95.0|-1.25|0.79|||Regression, Linear|||Intent-to-treat analyses tested changes in psychological safety from baseline to follow-up using linear mixed models. Mixed models analyses were conducted in R using the lme4 package and restricted maximum likelihood estimation (REML). Models included fixed effects of time (baseline vs. follow-up), intervention condition, and their interaction as well as random effects for person and team. We used the clubSandwich package to calculate cluster robust standard errors.||0.79|-1.25|.45
72503587|NCT05370157|144538163|SUPERIORITY||Mean Difference (Net)|-0.02|STANDARD_ERROR_OF_MEAN|0.1||0.89|TWO_SIDED|95.0|-0.44|0.4|||Regression, Linear|||Intent-to-treat analyses tested changes in learning behavior from baseline to follow-up using linear mixed models. Mixed models analyses were conducted in R using the lme4 package and restricted maximum likelihood estimation (REML). Models included fixed effects of time (baseline vs. follow-up), intervention condition, and their interaction as well as random effects for person and team. We used the clubSandwich package to calculate cluster robust standard errors.||0.40|-0.44|.89
72564699|NCT03919448|144660852|EQUIVALENCE|The comparable bioavailability was achieved if 90% confidence intervals (CIs) for the test to reference ratios of the geometric means of Cmax, Area under the serum concentration-time curve of bevacizumab (ABC0-t) fell within the 80.00-125.00% acceptance criteria.|Hazard Ratio (HR)|90.82||||0.3617|TWO_SIDED|90.0|81.21|101.57||Power of ANOVA: 0,95|ANOVA|||The null hypothesis (H0) of ANOVA is that there is no difference among group means. The alternate hypothesis (H1) is that at least one group differs significantly from the overall mean of the dependent variable.||101.57|81.21|0.3617
72466766|NCT03605368|144456920|EQUIVALENCE|Simple linear models ('lm' in R) were conducted. Statistical significance was set at p\<.05.|Mean Difference (Final Values)|0.19|STANDARD_ERROR_OF_MEAN|0.09||0.04|TWO_SIDED||||||Regression, Linear|||Appropriate Response. Change-from-baseline analyses were conducted (post-intervention assessment ratings minus pre-intervention assessment ratings) and compared between intervention groups (Floreo and TAU).||||.04
72466767|NCT03605368|144456920|EQUIVALENCE|Simple linear models ('lm' in R) were conducted. Statistical significance was set at p\<.05.|Mean Difference (Final Values)|0.34|STANDARD_ERROR_OF_MEAN|0.17||0.06|TWO_SIDED||||||Regression, Linear|||Appropriate Response. Change-from-baseline analyses were conducted (post-intervention assessment ratings minus pre-intervention assessment ratings) and compared between intervention groups (Floreo and TAU).||||.06
72466768|NCT03605368|144456920|EQUIVALENCE|Simple linear models ('lm' in R) were conducted. Statistical significance was set at p\<.05.|Mean Difference (Final Values)|0.24|STANDARD_ERROR_OF_MEAN|0.14||0.09|TWO_SIDED||||||Regression, Linear|||||||.09
72564700|NCT03919448|144660852|EQUIVALENCE|The comparable bioavailability was achieved if 90% confidence intervals (CIs) for the test to reference ratios of the geometric means of Cmax, Area under the serum concentration-time curve of bevacizumab (ABC0-t) fell within the 80.00-125.00% acceptance criteria.|Hazard Ratio (HR)|94.87||||0.3617|TWO_SIDED|90.0|84.91|105.99||Power of ANOVA: 0.95|ANOVA|||The null hypothesis (H0) of ANOVA is that there is no difference among group means. The alternate hypothesis (H1) is that at least one group differs significantly from the overall mean of the dependent variable.||105.99|84.91|0.3617
72370718|NCT00488683|144251643|SUPERIORITY_OR_OTHER||R-square|0.0057||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between memory B cells one month after primary vaccination and rise in serogroup specific IgG concentration after booster vaccination age for the serogroup A||||
72466769|NCT03605368|144456921|EQUIVALENCE|A linear regression compared change in Police Interaction Knowledge scores by group (Floreo vs. TAU) from pre- to post-intervention. Significance was set at p\<.05.|Mean Difference (Final Values)|1.62|STANDARD_ERROR_OF_MEAN|2.67||0.55|TWO_SIDED||||||Regression, Linear|||||||.55
72466770|NCT03605368|144456921|EQUIVALENCE|A linear regression compared change in Police Interaction Knowledge scores by group (Floreo vs. TAU) from pre- to post-intervention. Significance was set at p\<.05.|Mean Difference (Final Values)|5.42|STANDARD_ERROR_OF_MEAN|2.73||0.05|TWO_SIDED||||||Regression, Linear|||||||.05
72466771|NCT03559829|144456925|OTHER|||||||0.025|||||||paired t-test|||||||0.025
72466772|NCT03559829|144456926|OTHER|||||||0.01|||||||paired t-test|||||||0.01
72466773|NCT03559829|144456927|OTHER|||||||0.3|||||||paired t-test|||||||0.3
72466774|NCT03559829|144456928|OTHER|||||||0.098|||||||paired t-test|||||||0.098
72466775|NCT03559829|144456929|OTHER|||||||0.2|||||||paired t-test|||||||0.2
72466776|NCT03559829|144456930|OTHER|||||||0.07|||||||paired t-test|||||||0.07
72466777|NCT04088136|144456946|EQUIVALENCE|A one-tailed independent samples t-test was conducted. A p-value of .05 was used to determine statistical significance.|Mean Difference (Final Values)|-0.09|STANDARD_ERROR_OF_MEAN|0.17||0.67|TWO_SIDED|95.0|-0.42|0.55|||t-test, 2 sided|Use of pooled error term, df = 60.|Negative number reflects fewer errors in EMMI group, as predicted.|||0.55|-0.42|.67
72466778|NCT04088136|144456947|SUPERIORITY|Everyday Metacognitive Memory group predicted to have superior scores to Memory Strategy Control|Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.28|<|0.47|TWO_SIDED||||||t-test, 1 sided||pooled error term, equal variance assumption, df = 60|||||<.47
72466779|NCT04088136|144456948|SUPERIORITY||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|2.0|<|0.13|TWO_SIDED|95.0|-3.7|7.6|||t-test, 1 sided|||||7.6|-3.7|< .13
72466780|NCT04088136|144456949|EQUIVALENCE|Directional hypothesis of fewer errors in Everyday Metacognitive Memory group|Mean Difference (Final Values)|-1.1|STANDARD_ERROR_OF_MEAN|1.8||0.57|TWO_SIDED|95.0|-4.8|2.6||A p-value of .05 was used to determine statistical significance.|t-test, 2 sided|Pooled error term, df = 51||||2.6|-4.8|.57
72466781|NCT04088136|144456950|EQUIVALENCE|Two-tailed test of hypothesis of fewer errors in EMMI group|Mean Difference (Final Values)|0.8|STANDARD_ERROR_OF_MEAN|2.3||0.72|TWO_SIDED|95.0|-3.8|5.5||A p-value of .05 was used to determine statistical significance|t-test, 2 sided|Pooled error term, df = 49||||5.5|-3.8|.72
72466782|NCT04088136|144456951|OTHER|Test of Group X Time interaction|||||<|0.69|||||||Mixed Models Analysis|pooled df = 59||"We ran a 2 X 2 (Group X Time) mixed model analysis with repeated measures on Time (pretest, posttest).~Hypothesis was that Memory Strategy Control group would show greater improvements from pretest to posttest in recall scores"||||< .69
72466783|NCT04088136|144456952|OTHER|One-tailed test of Group X Time interaction|||||<|0.037|||||||Mixed Models Analysis|||"We ran a 2 X 2 (Group X Time) mixed effect model with repeated measures on Time (pretest-posttest).~Predicted hypothesis was greater pretest-posttest improvement in the Memory Strategy Contol group"||||< .037
72466784|NCT04088136|144456953|OTHER||Mean Difference (Final Values)|1.0|STANDARD_ERROR_OF_MEAN|9.9||0.69|TWO_SIDED|95.0|-4.0|8.4|||t-test, 2 sided||one instance of missing data due to computer failure during testing. Pooled error term resulting in df = 59|||8.4|-4.0|.69
72466785|NCT04088136|144456954|EQUIVALENCE|Directional hypothesis of shorter time in Everyday Metacognitive Memory group|Mean Difference (Final Values)|-50.0|STANDARD_ERROR_OF_MEAN|103.3||0.63|TWO_SIDED|95.0|-257.4|157.4||A p-value of .05 was used to determine statistical significance|t-test, 2 sided|Use of pooled error term, DF = 51||||157.4|-257.4|.63
72466786|NCT04088136|144456955|EQUIVALENCE|Two-tailed test of hypothesis of shorter time in Everyday Metacognitive Memory group|Mean Difference (Final Values)|10.6|STANDARD_ERROR_OF_MEAN|43.8||0.81|TWO_SIDED|95.0|-77.4|98.5||A p-value of .05 was used to determine statistical significance|t-test, 2 sided|Use of pooled error term, df = 49||||98.5|-77.4|.81
72466787|NCT04088136|144456956|OTHER||||||<|0.14|||||||Mixed Models Analysis|mixed procedure with unrestricted error covariance matrix. Pooled df for MSWithin = 60||We conducted a 2 X 2 (Group X Time) mixed effects model with repeated measures on Time (pretest, posttest). Hypothesis was greater reduction in memory complaints from pretest to posttest in EMMI group||||< .14
72466788|NCT04088136|144456957|OTHER|||||||0.037|||||||Mixed Models Analysis|||We ran a 2 X 2 (Group X Time) mixed effect model with repeated measures on Time (pretest-posttest)||||.037
72466789|NCT04088136|144456958|OTHER|Hypothesis was greater increase in memory self-efficacy for Everyday Metacognitive Memory group|||||<|0.33|||||||Mixed Models Analysis|mixed model specified unrestricted residual (error) covariance matrix. Pooled df in MS Error = 60||We ran a 2 X 2 (Group X Time) mixed effects model with repeated measures on Time (pretest, posttest).||||< .33
72466790|NCT04088136|144456959|OTHER||||||<|0.2|||||||Mixed Models Analysis|||We ran a 2 X 2 (Group X Time) mixed effects model with repeated measures on Time (pretest, posttest). Hypothesis was greater increase in memory control in EMMI group||||< .20
72564701|NCT03919448|144660852|EQUIVALENCE|As supplementary information, Test Product 1 vs. Test Product 2 shall also be compared. The comparable bioavailability was achieved if 90 % confidence intervals (CIs) for the test1-to-test2 ratios of the geometric means of Cmax, Area under the serum concentration-time curve of bevacizumab (ABC0-t) fell within the 80.00-125.00 % acceptance criteria.|Hazard Ratio (HR)|95.73||||0.3617|TWO_SIDED|90.0|84.82|108.05|||ANOVA|||The null hypothesis (H0) of ANOVA is that there is no difference among group means. The alternate hypothesis (H1) is that at least one group differs significantly from the overall mean of the dependent variable.||108.05|84.82|0.3617
72466791|NCT04088136|144456960|OTHER|Hypothesis was greater increase in use of external mnemonics in EMMI group|||||<|0.2|||||||Mixed Models Analysis|||||||< .20
72466792|NCT02250183|144456968|SUPERIORITY||Odds Ratio (OR)|1.0||||1|TWO_SIDED|||||A priori threshold for statistical significance was p\<0.05. Each case (participant) serves as its own control because they received both treatment modalities simultaneously.|McNemar|McNemar test was used because participants received both treatments, so this variable was non-independent in our single group sample.|2-sided|Each participant received both treatment modalities - MEDIHONEY® and SANTYL - and thus had two wound cultures performed, one for each treatment modality. This was a single group study; however, wound culture results were contrasted with each other across participants. Thus, independent variable was treatment modality, while dependent variable was the wound culture result (positive for presence of bacteria versus negative for absence of bacteria).||||1.00
72466793|NCT02250183|144456969|SUPERIORITY||Mean Difference (Final Values)|3.615|STANDARD_ERROR_OF_MEAN|0.79||0.003|TWO_SIDED|95.0|1.149|4.565||The null hypothesis was that the two mean scores would not differ significantly at p\<.05 level.|t-test, 2 sided|df = 13||A paired samples, 2-tailed, t-test was used to compare means within participants for ratings of MEDIHONEY and SANTYL satisfaction total scores. The null hypothesis was that the two mean scores would not differ significantly at p\<.05 level.||4.565|1.149|.003
72466794|NCT05896696|144456971|OTHER||Mean Difference (Final Values)|-1.87|||<|0.0001|TWO_SIDED|95.0|-2.49|-1.26|||Paired sample t-test|||||-1.26|-2.49|<0.0001
72466795|NCT05896696|144456972|OTHER||Mean Difference (Final Values)|-1.22|||<|0.0001|TWO_SIDED|95.0|-1.7|-0.73|||paired sample t-test|||||-0.73|-1.70|<0.0001
72466796|NCT01878383|144456977|OTHER|Sensitivity is the percent of non-pregnant women positive for shedding HSV by culture method in which GeneXpert test results is positive. Units equals percent non-pregnant women positive.|Sensitivity|100.0|||||TWO_SIDED|95.0|90.8|100.0|||||95% Clopper-Pearson Exact Confidence Interval|||100|90.8|
72466797|NCT01878383|144456978|OTHER|Positive percent agreement is the percent of pregnant women with positive routine PCR results in which GeneXpert test results is positive. Units equal percent of pregnant women positive.|Positive percent agreement|80.0|||||TWO_SIDED|95.0|73.7|86.3|||||95% large sample confidence interval|||86.3|73.7|
72466798|NCT01878383|144456979|OTHER|Negative percent agreement is the percent of pregnant women with negative routine PCR results in which GeneXpert test results is negative. Units equal percent of pregnant women negative.|Negative percent agreement|99.2|||||TWO_SIDED|95.0|99.0|99.5|||||95% large sample confidence interval|||99.5|99|
72466799|NCT00760513|144457046|SUPERIORITY||Mean Difference (Net)|-1.7||||0.48|TWO_SIDED|95.0|-6.3|3.0||The a priori threshold for statistical significance = P\</=0.05|Regression, Linear|Adjusted for baseline value of liver fat percentage||We estimated that a 20% decrease in liver fat with Omacor treatment, assuming a sigma of 0.3, and an alpha of 0.05; with 91 participants completing our trial, we had 86% power to detect a 20% change in liver fat (two tailed test) (see HEPATOLOGY 2014;60:1211-1221).||3.0|-6.3|0.48
72564702|NCT03919448|144660853|EQUIVALENCE|80.00-125.00% acceptance criteria.|Hazard Ratio (HR)|90.46||||0.3529|TWO_SIDED|90.0|80.64|101.47||Power of ANOVA: 0.94|ANOVA|||The null hypothesis (H0) of ANOVA is that there is no difference among group means. The alternate hypothesis (H1) is that at least one group differs significantly from the overall mean of the dependent variable.||101.47|80.64|0.3529
72564703|NCT03919448|144660853|EQUIVALENCE|80.00-125.00% acceptance criteria.|Hazard Ratio (HR)|95.02||||0.3529|TWO_SIDED|90.0|84.8|106.49||Power of ANOVA: 0.94|ANOVA|||||106.49|84.80|0.3529
72621766|NCT01197300|144773942|SUPERIORITY|Difference in least squares mean = LS mean for the Core treatment Zoledronic acid group - LS mean for the Core treatment Placebo group.|Difference in LS mean|2.36||||0.3544|TWO_SIDED|95.0|-2.886|7.606||An analysis of covariance (ANCOVA) model was performed with Core treatment, pooled centers, underlying condition treated with GCs and Core baseline lumbar spine BMD Z-score as explanatory variables and pooled centers as random effect.|ANCOVA|||Lumbar Spine BMC Change at Month 18||7.606|-2.886|0.3544
72466800|NCT00760513|144457047|SUPERIORITY||Mean Difference (Net)|-0.001||||1|TWO_SIDED|95.0|-0.3|0.3||A priori p value threshold \</=0.5|Regression, Linear|Adjusted for baseline||Based on the available evidence at the time, we assumed that a 0.6-1.0 unit change in fibrosis score might be clinically significant (Hepatology 2008 Feb;47(2):455-460). Consequently, to detect a minimum 0.6 unit change in score (e.g. 9.0 at baseline and 8.4 at the end of the study) with an SD of 1.0, 100 participants would provide \>80% power at the 5% significance level, and with a 15% drop out of participants there would also be \>80% power to detect this effect.||0.3|-0.3|1.0
72466801|NCT00760513|144457048|SUPERIORITY||Mean Difference (Net)|-0.03||||0.9|TWO_SIDED|95.0|-0.4|0.3||A priori threshold for statistical significance p \</=0.05|Regression, Linear|Adjusted for baseline measurement.||There was no power calculation for this end point.||0.3|-0.4|0.9
72466802|NCT01468077|144457051|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.0164|||||TWO_SIDED|95.0|-0.2685|0.2988|||||The CI (confidence interval) is calculated by Exact method based on binomial distribution.|||0.2988|-0.2685|
72466803|NCT03491215|144457075|OTHER|Comparison|GMR|0.801|||||TWO_SIDED|90.0|0.49|1.311||||||Group 3 vs Group 2||1.311|0.490|
72466804|NCT03491215|144457075|OTHER|Comparison|GMR|0.991|||||TWO_SIDED|90.0|0.532|1.846||||||Group 3 vs. Group 1||1.846|0.532|
72466805|NCT03491215|144457075|OTHER|Comparison|GMR|1.237|||||TWO_SIDED|90.0|0.639|2.394||||||Group 2 vs. Group 1||2.394|0.639|
72466806|NCT03491215|144457076|OTHER|Comparison|GMR|0.709|||||TWO_SIDED|90.0|0.425|1.184||||||Group 3 vs. Group 2||1.184|0.425|
72466807|NCT03491215|144457076|OTHER|Comparison|GMR|0.968|||||TWO_SIDED|90.0|0.506|1.851||||||Group 3 vs. Group 1||1.851|0.506|
72466808|NCT03491215|144457076|OTHER|Comparison|GMR|1.365|||||TWO_SIDED|90.0|0.686|2.714||||||Group 2 vs. Group 1||2.714|0.686|
72466809|NCT03491215|144457078|OTHER|Comparison|GMR|0.759|||||TWO_SIDED|90.0|0.245|2.352||||||Group 3 vs. Group 2||2.352|0.245|
72466810|NCT03491215|144457078|OTHER|Comparison|GMR|0.516|||||TWO_SIDED|90.0|0.15|1.784||||||Group 3 vs. Group 1||1.784|0.150|
72466811|NCT03491215|144457078|OTHER|Comparison|GMR|0.681|||||TWO_SIDED|90.0|0.178|2.597||||||Group 2 vs. Group 1||2.597|0.178|
72466812|NCT03491215|144457086|SUPERIORITY||Odds Ratio (OR)|0.976|||||TWO_SIDED|95.0|0.858|1.109||||||||1.109|0.858|
72466813|NCT03491215|144457086|SUPERIORITY||Odds Ratio (OR)|0.951|||||TWO_SIDED|95.0|0.735|1.232||||||||1.232|0.735|
72466814|NCT03491215|144457087|SUPERIORITY||Hazard Ratio (HR)|1.014|||||TWO_SIDED|95.0|0.921|1.115||||||||1.115|0.921|
72466815|NCT03491215|144457087|SUPERIORITY||Hazard Ratio (HR)|1.029|||||TWO_SIDED|95.0|0.841|1.258||||||||1.258|0.841|
72466816|NCT03491215|144457088|SUPERIORITY||Hazard Ratio (HR)|1.063|||||TWO_SIDED|95.0|1.012|1.117||||||||1.117|1.012|
72466817|NCT03491215|144457088|SUPERIORITY||Hazard Ratio (HR)|1.132|||||TWO_SIDED|95.0|1.025|1.25||||||||1.25|1.025|
72466818|NCT00553605|144457111|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower bound of the 2-sided 95% CI of the treatment difference (parecoxib - ketoprofen) was greater than -10 mm.|Least-squares (LS) mean difference|-1.12|STANDARD_ERROR_OF_MEAN|2.75|||TWO_SIDED|95.0|-6.53|4.3||||||LS mean difference and 95 percent (%) confidence interval (CI) were based on analysis of covariance (ANCOVA) model with terms for treatment group and country, and baseline as covariates.||4.30|-6.53|
72466819|NCT00553605|144457112|SUPERIORITY_OR_OTHER||LS mean difference|-0.09|STANDARD_ERROR_OF_MEAN|2.52||0.972|TWO_SIDED|95.0|-5.04|4.86|||ANCOVA|||p-value, LS mean difference and 95% CI were based on ANCOVA model with terms for treatment group and country, and baseline as covariates.||4.86|-5.04|0.972
72466820|NCT00553605|144457114|SUPERIORITY_OR_OTHER||LS mean difference|0.75|STANDARD_ERROR_OF_MEAN|2.56||0.768|TWO_SIDED|95.0|-4.28|5.79|||ANCOVA|||Minute 15: p-value, LS mean difference and 95% CI were based on ANCOVA model with terms for treatment group and country, and baseline as covariates.||5.79|-4.28|0.768
72466821|NCT00553605|144457114|SUPERIORITY_OR_OTHER||LS mean difference|-0.49|STANDARD_ERROR_OF_MEAN|2.91||0.866|TWO_SIDED|95.0|-6.22|5.24|||ANCOVA|||Minute 30: p-value, LS mean difference and 95% CI were based on ANCOVA model with terms for treatment group and country, and baseline as covariates.||5.24|-6.22|0.866
72466822|NCT00553605|144457114|SUPERIORITY_OR_OTHER||LS mean difference|0.94|STANDARD_ERROR_OF_MEAN|2.7||0.729|TWO_SIDED|95.0|-4.38|6.26|||ANCOVA|||Minute 45: p-value, LS mean difference and 95% CI were based on ANCOVA model with terms for treatment group and country, and baseline as covariates.||6.26|-4.38|0.729
72466823|NCT00553605|144457114|SUPERIORITY_OR_OTHER||LS mean difference|2.62|STANDARD_ERROR_OF_MEAN|2.47||0.29|TWO_SIDED|95.0|-2.24|7.48|||ANCOVA|||Minute 60: p-value, LS mean difference and 95% CI were based on ANCOVA model with terms for treatment group and country, and baseline as covariates.||7.48|-2.24|0.290
72466824|NCT00553605|144457114|SUPERIORITY_OR_OTHER||LS mean difference|2.16|STANDARD_ERROR_OF_MEAN|2.14||0.314|TWO_SIDED|95.0|-2.05|6.37|||ANCOVA|||Minute 90: p-value, LS mean difference and 95% CI were based on ANCOVA model with terms for treatment group and country, and baseline as covariates.||6.37|-2.05|0.314
72466825|NCT00553605|144457114|SUPERIORITY_OR_OTHER||LS mean difference|0.16|STANDARD_ERROR_OF_MEAN|1.72||0.926|TWO_SIDED|95.0|-3.23|3.55|||ANCOVA|||Minute 120: p-value, LS mean difference and 95% CI were based on ANCOVA model with terms for treatment group and country, and baseline as covariates.||3.55|-3.23|0.926
72466826|NCT00553605|144457115|SUPERIORITY_OR_OTHER||LS mean difference|10.13|STANDARD_ERROR_OF_MEAN|13.43||0.451|TWO_SIDED|95.0|-16.3|36.54|||ANCOVA|||p-value, LS mean difference and 95% CI were based on ANCOVA model with terms for treatment group and country as covariates.||36.54|-16.3|0.451
72466827|NCT00553605|144457116|SUPERIORITY_OR_OTHER|||||||0.3982|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Minute 30: p-value was calculated using Cochran-Mantel-Haenszel (CMH) model and using modified ridit scores, testing for non-zero correlation and controlling for country.||||0.3982
72503588|NCT05370157|144538164|SUPERIORITY||Mean Difference (Net)|-0.08|STANDARD_ERROR_OF_MEAN|0.36||0.85|TWO_SIDED|95.0|-1.51|1.36|||Regression, Linear|||Intent-to-treat analyses tested changes in team performance from baseline to follow-up using linear mixed models. Mixed models analyses were conducted in R using the lme4 package and restricted maximum likelihood estimation (REML). Models included fixed effects of time (baseline vs. follow-up), intervention condition, and their interaction as well as random effects for person and team. We used the clubSandwich package to calculate cluster robust standard errors.||1.36|-1.51|.85
72564704|NCT03919448|144660853|EQUIVALENCE|As supplementary information, Test Product 1 vs. Test Product 2 shall also be compared. The comparable bioavailability was achieved if 90 % confidence intervals (CIs) for the test1-to-test2 ratios of the geometric means of Cmax, Area under the serum concentration-time curve of bevacizumab (ABC0-t) fell within the 80.00-125.00 % acceptance criteria.|Hazard Ratio (HR)|95.19||||0.3529|TWO_SIDED|90.0|84.17|107.67|||ANOVA|||The null hypothesis (H0) of ANOVA is that there is no difference among group means. The alternate hypothesis (H1) is that at least one group differs significantly from the overall mean of the dependent variable.||107.67|84.17|0.3529
72564705|NCT01002794|144660863|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05|TWO_SIDED|95.0|||||Mixed Models Analysis|||Power calculation: The sample size calculation was based on the change in KOOS4 from baseline to two year follow-up. To detect a 10 point difference with a standard deviation of 15, with a level of power of 90%, level of significance of 0.05, and an estimated 15% dropout rate at two years, we determined that we would need 56 participants in each group. To allow for a 20% crossover rate, we randomised 140 participants.||||<0.05
72466828|NCT00553605|144457116|SUPERIORITY_OR_OTHER|||||||0.5552|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Minute 120: p-value was calculated using Cochran-Mantel-Haenszel (CMH) model and using modified ridit scores, testing for non-zero correlation and controlling for country.||||0.5552
72466829|NCT00553605|144457117|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.007||||0.9785|TWO_SIDED|95.0|0.6|1.69|||Regression, Logistic|||p-value was based on logistic regression model with terms for treatment group and baseline as covariates.||1.69|0.60|0.9785
72564706|NCT03662308|144660899|SUPERIORITY||Mean Difference (Final Values)|0.6|||<|0.05|TWO_SIDED||||||ANOVA|||||||<0.05
72466830|NCT00553605|144457118|SUPERIORITY_OR_OTHER|||||||0.2482|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Minute 30: p-value was calculated using Cochran-Mantel-Haenszel (CMH) model and using modified ridit scores, testing for non-zero correlation and controlling for country.||||0.2482
72466831|NCT00553605|144457118|SUPERIORITY_OR_OTHER|||||||0.7659|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Minute 120: p-value was calculated using CMH model and using modified ridit scores, testing for non-zero correlation and controlling for country.||||0.7659
72466832|NCT00553605|144457119|SUPERIORITY_OR_OTHER|||||||0.9783|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Minute 30: p-value was calculated using CMH model and using modified ridit scores, testing for non-zero correlation and controlling for country.||||0.9783
72503589|NCT01144637|144538191|EQUIVALENCE|The equivalence margins to show that the 3 vaccine lots are equivalent in terms of PRNT GMTs at Week 6 was predefined as \[0.5; 2\] for the GMT ratios (pairwise)|GMT ratio (Group 1 / Group 2)|1.1012|||||TWO_SIDED|95.0|0.9992|1.2136||||||||1.2136|0.9992|
72466833|NCT00553605|144457119|SUPERIORITY_OR_OTHER|||||||0.6847|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Minute 120: p-value was calculated using CMH model and using modified ridit scores, testing for non-zero correlation and controlling for country.||||0.6847
72466834|NCT00553605|144457120|SUPERIORITY_OR_OTHER|||||||0.9645|TWO_SIDED||||||Log Rank|||||||0.9645
72466835|NCT02669407|144457127|OTHER|Single group|||||<|0.001|||||||Tukey's method|||||||<0.001
72466836|NCT02669407|144457128|OTHER|Single group||||||0.001|||||||Tukey's method|||Baseline, 30 minutes||||0.001
72466837|NCT02669407|144457129|OTHER|Single group||||||0.007|||||||Tukey's method|||baseline, 30 minutes||||0.007
72466838|NCT02669407|144457133|OTHER|Single group||||||0.237|||||||t-test, 2 sided|||Change in left ventricular end diastolic dimension||||0.237
72466839|NCT02669407|144457133|OTHER|Single group||||||0.586|||||||t-test, 2 sided|||Change in left ventricular end systolic dimension||||0.586
72466840|NCT02669407|144457134|OTHER|Single group||||||0.175|||||||t-test, 2 sided|||||||0.175
72466841|NCT02669407|144457136|OTHER|Single group||||||0.061|||||||t-test, 2 sided|||||||0.061
72466842|NCT02669407|144457137|OTHER|Single group||||||0.787|||||||t-test, 2 sided|||||||0.787
72466843|NCT02669407|144457139|OTHER|Single group||||||0.606|||||||t-test, 2 sided|||Baseline, 90 minutes||||0.606
72466844|NCT02669407|144457139|OTHER|Single group||||||0.045|||||||t-test, 2 sided|||Baseline, 24 hours||||0.045
72466845|NCT01006616|144457291|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.031||||0.325|TWO_SIDED|95.0|-0.03|0.091|||Constrained Longitudinal Data Analysis|Model with treatment, time, treatment by time interaction, and baseline smoking status (yes/no) and inhaled corticosteroid (ICS) use (yes/no)||||0.091|-0.030|0.325
72503590|NCT01144637|144538191|EQUIVALENCE|The equivalence margins to show that the 3 vaccine lots are equivalent in terms of PRNT GMTs at Week 6 was predefined as \[0.5; 2\] for the GMT ratios (pairwise)|GMT ratio (Group 1 / Group 3)|0.9444|||||TWO_SIDED|95.0|0.8554|1.0427||||||||1.0427|0.8554|
72503591|NCT01144637|144538191|EQUIVALENCE|The equivalence margins to show that the 3 vaccine lots are equivalent in terms of PRNT GMTs at Week 6 was predefined as \[0.5; 2\] for the GMT ratios (pairwise)|GMT ratio (Group 2 / Group 3)|0.8577|||||TWO_SIDED|95.0|0.7753|0.9488||||||||0.9488|0.7753|
72503592|NCT05593432|144538210|SUPERIORITY||Response Rate Difference|29.4|STANDARD_ERROR_OF_MEAN|11.17||0.0129|TWO_SIDED|95.0|7.55|51.33||stratified by Baseline Investigator's Global Assessment (IGA) score (3 or 4)|Cochran-Mantel-Haenszel||stratified by Baseline IGA score (3 or 4)|||51.33|7.55|0.0129
72503593|NCT05593432|144538210|SUPERIORITY||Odds Ratio (OR)|4.04|||||TWO_SIDED|95.0|1.32|12.38|||||stratified by Baseline IGA score (3 or 4)|||12.38|1.32|
72466846|NCT01006616|144457291|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.029||||0.37|TWO_SIDED|95.0|-0.091|0.034|||Constrained Longitudinal Data Analysis|Model with treatment, time, treatment by time interaction, and baseline smoking status (yes/no) and ICS use (yes/no)||||0.034|-0.091|0.370
72466847|NCT01006616|144457291|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.067||||0.037|TWO_SIDED|95.0|0.004|0.131|||Constrained Longitudinal Data Analysis|Model with treatment, time, treatment by time interaction, and baseline smoking status (yes/no) and ICS use (yes/no)||||0.131|0.004|0.037
72466848|NCT01006616|144457292|SUPERIORITY_OR_OTHER||Difference in percentages|2.6||||0.096|TWO_SIDED|95.0|-0.6|6.9|||Miettinen and Nurminen||Analysis of Week 26 data|||6.9|-0.6|0.096
72466849|NCT01006616|144457292|SUPERIORITY_OR_OTHER||Difference in percentages|12.2|||<|0.001|TWO_SIDED|95.0|7.4|18.4|||Miettinen and Nurminen||Analysis of Week 26 data|||18.4|7.4|<0.001
72466850|NCT01006616|144457292|SUPERIORITY_OR_OTHER||Difference in percentages|19.7|||<|0.001|TWO_SIDED|95.0|13.8|26.9|||Miettinen and Nurminen||Analysis of Week 26 data|||26.9|13.8|<0.001
72466851|NCT03672175|144457323|SUPERIORITY||Least Square (LS) Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.85||0.6638|TWO_SIDED|95.0|-2.0|1.3||MMRM was used for analysis with change from BL in HAM-D total score as dependent variable; treatment, BL HAM-D total score, antidepressant use, assessment time point, time point-by-treatment interaction as explanatory variables and fixed effects.|MMRM|||Mixed effect model for repeated measures (MMRM)||1.3|-2.0|0.6638
72503594|NCT05593432|144538211|EQUIVALENCE|A Cochran-Mantel-Haenszel test stratified by Baseline IGA score (3 or 4) at a 2-sided α = 0.05 level was used for the comparison between ruxolitinib 1.5% cream BID and vehicle cream BID at Week 16.|Response Rate Difference|30.6|STANDARD_ERROR_OF_MEAN|11.68||0.0141|TWO_SIDED|95.0|7.71|53.51|||Cochran-Mantel-Haenszel|stratified by Baseline IGA score (3 or 4)||||53.51|7.71|0.0141
72466852|NCT03672175|144457323|SUPERIORITY||LS Mean Difference|-1.4|STANDARD_ERROR_OF_MEAN|0.89||0.1158|TWO_SIDED|95.0|-3.1|0.3||MMRM was used for analysis with change from BL in HAM-D total score as dependent variable; treatment, BL HAM-D total score, antidepressant use, assessment time point, time point-by-treatment interaction as explanatory variables and fixed effects.|MMRM|||||0.3|-3.1|0.1158
72466853|NCT03672175|144457324|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.15||0.6905|TWO_SIDED|95.0|-0.4|0.2||MMRM was used for the analysis. Treatment, BL CGI-S score, BL antidepressant use, assessment time point, and time point-by-treatment interaction were included in the model and were treated as fixed effects.|MMRM|||||0.2|-0.4|0.6905
72466854|NCT03672175|144457324|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.15||0.1082|TWO_SIDED|95.0|-0.5|0.1||MMRM was used for the analysis. Treatment, BL CGI-S score, BL antidepressant use, assessment time point, and time point-by-treatment interaction were included in the model and were treated as fixed effects.|MMRM|||||0.1|-0.5|0.1082
72466855|NCT03672175|144457325|SUPERIORITY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.65||0.5725|TWO_SIDED|95.0|-1.7|0.9||MMRM was used for analysis with change from BL in HAM-D total score as dependent variable; treatment, BL HAM-D total score, antidepressant use, assessment time point, time point-by-treatment interaction as explanatory variables and fixed effects.|MMRM|||Day 3||0.9|-1.7|0.5725
72466856|NCT03672175|144457325|SUPERIORITY||LS Mean Difference|-1.5|STANDARD_ERROR_OF_MEAN|0.64||0.016|TWO_SIDED|95.0|-2.8|-0.3||MMRM was used for analysis with change from BL in HAM-D total score as dependent variable; treatment, BL HAM-D total score, antidepressant use, assessment time point, time point-by-treatment interaction as explanatory variables and fixed effects.|MMRM|||Day 3||-0.3|-2.8|0.0160
72503595|NCT05593432|144538211|EQUIVALENCE|A Cochran-Mantel-Haenszel test stratified by Baseline IGA score (3 or 4) at a 2-sided α = 0.05 level was used for the comparison between ruxolitinib 1.5% cream BID and vehicle cream BID at Week 16.|Odds Ratio (OR)|4.16|||||TWO_SIDED|95.0|1.31|13.17|||||stratified by Baseline IGA score (3 or 4)|||13.17|1.31|
72564707|NCT03476317|144660913|EQUIVALENCE|Median difference in calprotectin for controls from day 12 to baseline||||||1|||||||Wilcoxon (Mann-Whitney)|||||||1.0
72394561|NCT02310568|144295791|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|1.45||0.856|TWO_SIDED|90.0|-2.2|2.7|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - Placebo). Week 1: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1.||2.7|-2.2|0.856
72466857|NCT03672175|144457325|SUPERIORITY||LS Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.75||0.445|TWO_SIDED|95.0|-2.1|0.9||MMRM was used for analysis with change from BL in HAM-D total score as dependent variable; treatment, BL HAM-D total score, antidepressant use, assessment time point, time point-by-treatment interaction as explanatory variables and fixed effects.|MMRM|||Day 8||0.9|-2.1|0.4450
72466858|NCT03672175|144457325|SUPERIORITY||LS Mean Difference|-2.1|STANDARD_ERROR_OF_MEAN|0.79||0.0081|TWO_SIDED|95.0|-3.6|-0.5||MMRM was used for analysis with change from BL in HAM-D total score as dependent variable; treatment, BL HAM-D total score, antidepressant use, assessment time point, time point-by-treatment interaction as explanatory variables and fixed effects.|MMRM|||Day 8||-0.5|-3.6|0.0081
72503596|NCT05593432|144538213|EQUIVALENCE|A Cochran-Mantel-Haenszel test stratified by Baseline IGA score (3 or 4) at a 2-sided α = 0.05 level was used for the comparison between ruxolitinib 1.5% cream BID and vehicle cream BID at Week 16.|Response Rate Difference|40.3|STANDARD_ERROR_OF_MEAN|12.09||0.0027|TWO_SIDED|95.0|16.61|64.0|||Cochran-Mantel-Haenszel|stratified by Baseline IGA score (3 or 4)||||64.00|16.61|0.0027
72503597|NCT05593432|144538213|EQUIVALENCE|A Cochran-Mantel-Haenszel test stratified by Baseline IGA score (3 or 4) at a 2-sided α = 0.05 level was used for the comparison between ruxolitinib 1.5% cream BID and vehicle cream BID at Week 16.|Odds Ratio (OR)|6.67|||||TWO_SIDED|95.0|1.85|24.02|||||stratified by Baseline IGA score (3 or 4)|||24.02|1.85|
72466859|NCT03672175|144457325|SUPERIORITY||LS Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|0.95||0.8219|TWO_SIDED|95.0|-1.6|2.1||MMRM was used for analysis with change from BL in HAM-D total score as dependent variable; treatment, BL HAM-D total score, antidepressant use, assessment time point, time point-by-treatment interaction as explanatory variables and fixed effects.|MMRM|||Day 42||2.1|-1.6|0.8219
72466860|NCT03672175|144457325|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.92||0.8166|TWO_SIDED|95.0|-2.0|1.6||MMRM was used for analysis with change from BL in HAM-D total score as dependent variable; treatment, BL HAM-D total score, antidepressant use, assessment time point, time point-by-treatment interaction as explanatory variables and fixed effects.|MMRM|||Day 42||1.6|-2.0|0.8166
72466861|NCT03672175|144457325|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|1.11||0.9|TWO_SIDED|95.0|-2.3|2.0||MMRM was used for analysis with change from BL in HAM-D total score as dependent variable; treatment, BL HAM-D total score, antidepressant use, assessment time point, time point-by-treatment interaction as explanatory variables and fixed effects.|MMRM|||Day 182||2.0|-2.3|0.9000
72466862|NCT03672175|144457325|SUPERIORITY||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|1.03||0.5004|TWO_SIDED|95.0|-2.7|1.3||MMRM was used for analysis with change from BL in HAM-D total score as dependent variable; treatment, BL HAM-D total score, antidepressant use, assessment time point, time point-by-treatment interaction as explanatory variables and fixed effects.|MMRM|||Day 182||1.3|-2.7|0.5004
72466863|NCT03672175|144457326|SUPERIORITY||Odds Ratio (OR)|1.03||||0.8903|TWO_SIDED|95.0|0.65|1.63||GEE for binary response model, with factors for treatment, BL HAM-D total score, stratification factor (anti-depressant use at BL), assessment time point, and time point-by-treatment interaction were used for analysis.|GEE|||Day 15: Generalized estimating equation (GEE)||1.63|0.65|0.8903
72466864|NCT03672175|144457326|SUPERIORITY||Odds Ratio (OR)|1.43||||0.1207|TWO_SIDED|95.0|0.91|2.25||GEE for binary response model, with factors for treatment, BL HAM-D total score, stratification factor (anti-depressant use at BL), assessment time point, and time point-by-treatment interaction were used for analysis.|GEE|||Day 15||2.25|0.91|0.1207
72466865|NCT03672175|144457326|SUPERIORITY||Odds Ratio (OR)|1.07||||0.7897|TWO_SIDED|95.0|0.67|1.7||GEE for binary response model, with factors for treatment, BL HAM-D total score, stratification factor (anti-depressant use at BL), assessment time point, and time point-by-treatment interaction were used for analysis.|GEE|||Day 42||1.70|0.67|0.7897
72466866|NCT03672175|144457326|SUPERIORITY||Odds Ratio (OR)|1.1||||0.6837|TWO_SIDED|95.0|0.69|1.76||GEE for binary response model, with factors for treatment, BL HAM-D total score, stratification factor (anti-depressant use at BL), assessment time point, and time point-by-treatment interaction were used for analysis.|GEE|||Day 42||1.76|0.69|0.6837
72503598|NCT05593432|144538215|EQUIVALENCE|A log-rank test stratified by randomization stratification factor, Baseline IGA score (3 or 4), was used for between-treatment group comparisons. The hazard ratio and its 95% confidence interval was estimated based on the stratified Cox regression model. using Efron's method accounting for ties.|Hazard Ratio (HR)|2.85||||0.0008|TWO_SIDED|95.0|1.51|5.381|||Log Rank|stratified by Baseline IGA score (3 or 4) between ruxolitinib 1.5% cream and vehicle cream|Cox regression model stratified by Baseline IGA score (3 or 4) was conducted to compare the difference in hazard rate between ruxolitinib 1.5% cream and vehicle cream|||5.381|1.510|0.0008
72564708|NCT04019054|144660975|SUPERIORITY|Repeated-measure MANOVA was utilized to compare control and active group.||||||0.518|||||||ANOVA|||||||0.518
72466867|NCT03672175|144457326|SUPERIORITY||Odds Ratio (OR)|0.88||||0.6602|TWO_SIDED|95.0|0.51|1.53||GEE for binary response model, with factors for treatment, BL HAM-D total score, stratification factor (anti-depressant use at BL), assessment time point, and time point-by-treatment interaction were used for analysis.|GEE|||Day 182||1.53|0.51|0.6602
72466868|NCT03672175|144457326|SUPERIORITY||Odds Ratio (OR)|0.97||||0.9268|TWO_SIDED|95.0|0.56|1.69||GEE for binary response model, with factors for treatment, BL HAM-D total score, stratification factor (anti-depressant use at BL), assessment time point, and time point-by-treatment interaction were used for analysis.|GEE|||Day 182||1.69|0.56|0.9268
72564709|NCT04019054|144660976|SUPERIORITY|Repeated-measure MANOVA was utilized to compare control and active group. This allowed for examination between and within each group. Analysis described here is within-group differences.||||||0.008||||||a priori threshold for significance of p=0.05. Observed power η2=0.39.|ANOVA|||||||0.008
72394562|NCT02310568|144295791|SUPERIORITY_OR_OTHER||LS Mean Difference|0.6|STANDARD_ERROR_OF_MEAN|1.38||0.647|TWO_SIDED|90.0|-1.7|2.9|||Mixed-Effects Model Repeated Measure|||(PF-06372865 2.5 mg - Placebo). Week 1: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1.||2.9|-1.7|0.647
72466869|NCT03672175|144457327|SUPERIORITY||Odds Ratio (OR)|1.06||||0.8245|TWO_SIDED|95.0|0.62|1.83||GEE for binary response model, with factors for treatment, BL HAM-D total score, stratification factor (anti-depressant use at BL), assessment time point, and time point-by-treatment interaction were used for analysis.|GEE|||Day 15||1.83|0.62|0.8245
72466870|NCT03672175|144457327|SUPERIORITY||Odds Ratio (OR)|1.59||||0.0756|TWO_SIDED|95.0|0.95|2.67||GEE for binary response model, with factors for treatment, BL HAM-D total score, stratification factor (anti-depressant use at BL), assessment time point, and time point-by-treatment interaction were used for analysis.|GEE|||Day 15||2.67|0.95|0.0756
72466871|NCT03672175|144457327|SUPERIORITY||Odds Ratio (OR)|1.18||||0.5309|TWO_SIDED|95.0|0.7|2.01||GEE for binary response model, with factors for treatment, BL HAM-D total score, stratification factor (anti-depressant use at BL), assessment time point, and time point-by-treatment interaction were used for analysis.|GEE|||Day 42||2.01|0.70|0.5309
72466872|NCT03672175|144457327|SUPERIORITY||Odds Ratio (OR)|0.97||||0.9085|TWO_SIDED|95.0|0.56|1.66||GEE for binary response model, with factors for treatment, BL HAM-D total score, stratification factor (anti-depressant use at BL), assessment time point, and time point-by-treatment interaction were used for analysis.|GEE|||Day 42||1.66|0.56|0.9085
72466873|NCT03672175|144457327|SUPERIORITY||Odds Ratio (OR)|1.34||||0.3476|TWO_SIDED|95.0|0.73|2.44||GEE for binary response model, with factors for treatment, BL HAM-D total score, stratification factor (anti-depressant use at BL), assessment time point, and time point-by-treatment interaction were used for analysis.|GEE|||Day 182||2.44|0.73|0.3476
72466874|NCT03672175|144457327|SUPERIORITY||Odds Ratio (OR)|1.45||||0.206|TWO_SIDED|95.0|0.82|2.57||GEE for binary response model, with factors for treatment, BL HAM-D total score, stratification factor (anti-depressant use at BL), assessment time point, and time point-by-treatment interaction were used for analysis.|GEE|||Day 182||2.57|0.82|0.2060
72466875|NCT03672175|144457328|SUPERIORITY||Odds Ratio (OR)|1.05||||0.8303|TWO_SIDED|95.0|0.67|1.65||GEE for binary response model, with factors for treatment, CGI-S BL score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction were used for analysis.|GEE|||||1.65|0.67|0.8303
72466876|NCT03672175|144457328|SUPERIORITY||Odds Ratio (OR)|1.43||||0.1199|TWO_SIDED|95.0|0.91|2.24||GEE for binary response model, with factors for treatment, CGI-S BL score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction were used for analysis.|GEE|||||2.24|0.91|0.1199
72503599|NCT03476850|144538222|SUPERIORITY||Mean Difference (Final Values)|0.08||||0.883|TWO_SIDED||||||Mixed Models Analysis|||An a priori sample size calculation found 24 subjects per group (48 total) provided \>80% power to detect a 2 unit difference in patient reported pain based on a 2-sided test and significance level a = 0.05 assuming at least 3 measures per subject and a within subject covariance having a compound symmetric structure with a standard deviation in pain score of 3 units and within subject correlation of 0.5.||||.883
72503600|NCT03476850|144538223|SUPERIORITY||Median Difference (Final Values)|0.25||||0.977|TWO_SIDED||||||ANOVA|||||||.977
72503601|NCT03476850|144538224|SUPERIORITY||Odds Ratio (OR)|4.9||||0.009|TWO_SIDED||||||Chi-squared|||||||.009
72503602|NCT03476850|144538226|SUPERIORITY||Median Difference (Final Values)|18.0||||0.11|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.110
72564710|NCT04019054|144660976|SUPERIORITY|Repeated-measure MANOVA was utilized to compare control and active group. This allowed for examination between and within each group. Analysis described here is between-group differences.|||||>|0.05||||||a priori threshold for significance of p=0.05.|ANOVA|||||||>0.05
72466877|NCT03672175|144457329|SUPERIORITY||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.71||0.5021|TWO_SIDED|95.0|-1.9|0.9||MMRM with treatment, BL HAM-A total score, anti-depressant use at BL (Yes or No), assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||||0.9|-1.9|0.5021
72466878|NCT03672175|144457329|SUPERIORITY||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.7||0.2868|TWO_SIDED|95.0|-2.1|0.6||MMRM with treatment, BL HAM-A total score, anti-depressant use at BL (Yes or No), assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||||0.6|-2.1|0.2868
72466879|NCT03672175|144457330|SUPERIORITY||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|1.35||0.5987|TWO_SIDED|95.0|-3.4|1.9||MMRM with treatment, BL MADRS total score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||||1.9|-3.4|0.5987
72466880|NCT03672175|144457330|SUPERIORITY||LS Mean Difference|-2.0|STANDARD_ERROR_OF_MEAN|1.36||0.1443|TWO_SIDED|95.0|-4.7|0.7||MMRM with treatment, BL MADRS total score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||||0.7|-4.7|0.1443
72564711|NCT04019054|144660977|SUPERIORITY|Repeated-measure MANOVA was utilized to compare control and active group. This allowed for examination between and within each group. Result described here is within-group difference over time.||||||0.004||||||a priori threshold for significance p=0.05. Result above describes within group testing over time. Observed power η2=0.43.|ANOVA|||||||0.004
72564712|NCT04019054|144660977|SUPERIORITY|Repeated-measure MANOVA was utilized to compare control and active group. This allowed for examination between and within each group. Result described here is the between-group comparison|||||>|0.05||||||a priori threshold for significance p=0.05|ANOVA|||||||>0.05
72466881|NCT03672175|144457331|SUPERIORITY||LS Mean Difference|0.4|STANDARD_ERROR_OF_MEAN|1.87||0.8499|TWO_SIDED|95.0|-3.3|4.0||MMRM with treatment, BL HAM-D core subscale score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15||4.0|-3.3|0.8499
72503603|NCT03476850|144538227|SUPERIORITY||Median Difference (Final Values)|0.26||||0.719|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.719
72503604|NCT02912364|144538240|OTHER||Mean Difference (Final Values)|0.23|||<|0.001|TWO_SIDED|95.0|0.13|0.34|||t-test, 2 sided|degrees of freedom = 22||||.34|.13|< .001
72503605|NCT02912364|144538241|OTHER||Mean Difference (Final Values)|0.54|||<|0.001|TWO_SIDED|95.0|0.3|0.79|||t-test, 2 sided|Degrees of freedom = 22.||||.79|.30|< .001
72503606|NCT04800315|144538248|SUPERIORITY||Mean Difference (Final Values)|-21.76||||0.003|TWO_SIDED|95.0|-35.81|-7.7|||ANCOVA|||||-7.70|-35.81|0.003
72503607|NCT04800315|144538248|SUPERIORITY||Mean Difference (Final Values)|-13.38||||0.057|TWO_SIDED|95.0|-27.19|0.43|||ANCOVA|||||0.43|-27.19|0.057
72503608|NCT04800315|144538248|SUPERIORITY||Mean Difference (Final Values)|-16.28||||0.029|TWO_SIDED|95.0|-30.88|-1.68|||ANCOVA|||||-1.68|-30.88|0.029
72503609|NCT04800315|144538249|OTHER|Risk Difference|Risk Difference VS Placebo|24.0||||0.004|TWO_SIDED|95.0|8.8|39.2|||Cochran-Mantel-Haenszel|||||39.2|8.8|0.004
72466882|NCT03672175|144457331|SUPERIORITY||LS Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|1.88||0.6265|TWO_SIDED|95.0|-4.6|2.8||MMRM with treatment, BL HAM-D core subscale score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15||2.8|-4.6|0.6265
72466883|NCT03672175|144457331|SUPERIORITY||LS Mean Difference|0.7|STANDARD_ERROR_OF_MEAN|1.97||0.7418|TWO_SIDED|95.0|-3.2|4.5||MMRM with treatment, BL HAM-D core subscale score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 42||4.5|-3.2|0.7418
72466884|NCT03672175|144457331|SUPERIORITY||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|1.94||0.7837|TWO_SIDED|95.0|-4.3|3.3||MMRM with treatment, BL HAM-D core subscale score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 42||3.3|-4.3|0.7837
72466885|NCT03672175|144457332|SUPERIORITY||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|1.74||0.6848|TWO_SIDED|95.0|-4.1|2.7||MMRM with treatment, BL HAM-D anxiety subscale score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15||2.7|-4.1|0.6848
72466886|NCT03672175|144457332|SUPERIORITY||LS Mean Difference|-2.7|STANDARD_ERROR_OF_MEAN|1.72||0.11|TWO_SIDED|95.0|-6.1|0.6||MMRM with treatment, BL HAM-D anxiety subscale score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15||0.6|-6.1|0.1100
72466887|NCT03672175|144457332|SUPERIORITY||LS Mean Difference|1.2|STANDARD_ERROR_OF_MEAN|1.86||0.509|TWO_SIDED|95.0|-2.4|4.9||MMRM with treatment, BL HAM-D anxiety subscale score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 42||4.9|-2.4|0.5090
72466888|NCT03672175|144457332|SUPERIORITY||LS Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|1.77||0.8948|TWO_SIDED|95.0|-3.2|3.7||MMRM with treatment, BL HAM-D anxiety subscale score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 42||3.7|-3.2|0.8948
72466889|NCT03672175|144457333|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|2.25||0.9591|TWO_SIDED|95.0|-4.5|4.3||MMRM with treatment, BL HAM-D Bech-6 subscale score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15||4.3|-4.5|0.9591
72466890|NCT03672175|144457333|SUPERIORITY||LS Mean Difference|-2.5|STANDARD_ERROR_OF_MEAN|2.28||0.2713|TWO_SIDED|95.0|-7.0|2.0||MMRM with treatment, BL HAM-D Bech-6 subscale score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15||2.0|-7.0|0.2713
72466891|NCT03672175|144457333|SUPERIORITY||LS Mean Difference|0.6|STANDARD_ERROR_OF_MEAN|2.43||0.8048|TWO_SIDED|95.0|-4.2|5.4||MMRM with treatment, BL HAM-D Bech-6 subscale score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 42||5.4|-4.2|0.8048
72466892|NCT03672175|144457333|SUPERIORITY||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|2.35||0.7665|TWO_SIDED|95.0|-5.3|3.9||MMRM with treatment, BL HAM-D Bech-6 subscale score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 42||3.9|-5.3|0.7665
72466893|NCT03672175|144457334|SUPERIORITY||LS Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|1.91||0.8575|TWO_SIDED|95.0|-3.4|4.1||MMRM with treatment, BL HAM-D Maier subscale score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15||4.1|-3.4|0.8575
72466894|NCT03672175|144457334|SUPERIORITY||LS Mean Difference|-2.5|STANDARD_ERROR_OF_MEAN|1.94||0.1978|TWO_SIDED|95.0|-6.3|1.3||MMRM with treatment, BL HAM-D Maier subscale score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15||1.3|-6.3|0.1978
72503610|NCT04800315|144538249|OTHER|Risk Difference|Risk Difference VS Placebo|15.3||||0.061|TWO_SIDED|95.0|0.8|29.8|||Cochran-Mantel-Haenszel|||||29.8|0.8|0.061
72466895|NCT03672175|144457334|SUPERIORITY||LS Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|2.08||0.9298|TWO_SIDED|95.0|-3.9|4.3||MMRM with treatment, BL HAM-D Maier subscale score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 42||4.3|-3.9|0.9298
72466896|NCT03672175|144457334|SUPERIORITY||LS Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|2.03||0.5487|TWO_SIDED|95.0|-5.2|2.8||MMRM with treatment, BL HAM-D Maier subscale score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 42||2.8|-5.2|0.5487
72466897|NCT03672175|144457335|SUPERIORITY||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.14||0.627|TWO_SIDED|95.0|-0.2|0.3||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15: Depressed Mood||0.3|-0.2|0.6270
72466898|NCT03672175|144457335|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.14||0.5463|TWO_SIDED|95.0|-0.4|0.2||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15: Depressed Mood||0.2|-0.4|0.5463
72466899|NCT03672175|144457335|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.15||0.8716|TWO_SIDED|95.0|-0.3|0.3||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 42: Depressed Mood||0.3|-0.3|0.8716
72466900|NCT03672175|144457335|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.14||0.4383|TWO_SIDED|95.0|-0.4|0.2||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 42: Depressed Mood||0.2|-0.4|0.4383
72503611|NCT04800315|144538249|OTHER|Risk Difference|Risk Difference VS Placebo|28.9|||<|0.001|TWO_SIDED|95.0|13.6|44.2|||Cochran-Mantel-Haenszel|||||44.2|13.6|<0.001
72503612|NCT04800315|144538250|OTHER|Risk Difference|Difference VS Placebo|23.7||||0.018|TWO_SIDED|95.0|6.2|41.2|||Cochran-Mantel-Haenszel|||||41.2|6.2|0.018
72503613|NCT04800315|144538250|OTHER|Risk Difference|Difference VS Placebo|21.8||||0.033|TWO_SIDED|95.0|4.3|39.3|||Cochran-Mantel-Haenszel|||||39.3|4.3|0.033
72466901|NCT03672175|144457335|SUPERIORITY||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.1||0.4794|TWO_SIDED|95.0|-0.1|0.3||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15: Feelings of Guilt||0.3|-0.1|0.4794
72564713|NCT04019054|144660978|OTHER|This was a goodness of fit test of a multi-level model, fit was tested using a wald chi-square test.|||||<|0.01||||||Threshold for significance was p=0.05.|Chi-squared|This was specifically a wald chi-square test, performed in Stata for the purpose of assessing goodness-of-fit of a mixed effects model||Goodness of fit test of a two-variable negative binomial multi-level model of skin conductance level (SCL) as a function of step and timepoint. This multi-level model was generated using the menbreg function in Stata 16||||<0.01
72394563|NCT02310568|144295791|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|1.6||0.817|TWO_SIDED|90.0|-3.0|2.3|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 1: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1.||2.3|-3.0|0.817
72466902|NCT03672175|144457335|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.1||0.9717|TWO_SIDED|95.0|-0.2|0.2||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15: Feelings of Guilt||0.2|-0.2|0.9717
72466903|NCT03672175|144457335|SUPERIORITY||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.11||0.3701|TWO_SIDED|95.0|-0.1|0.3||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 42: Feelings of Guilt||0.3|-0.1|0.3701
72466904|NCT03672175|144457335|SUPERIORITY||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.11||0.3972|TWO_SIDED|95.0|-0.1|0.3||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 42: Feelings of Guilt||0.3|-0.1|0.3972
72466905|NCT03672175|144457335|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.06||0.5761|TWO_SIDED|95.0|-0.1|0.1||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15: Suicide||0.1|-0.1|0.5761
72466906|NCT03672175|144457335|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.05||0.4379|TWO_SIDED|95.0|-0.1|0.1||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15: Suicide||0.1|-0.1|0.4379
72466907|NCT03672175|144457335|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.06||0.6087|TWO_SIDED|95.0|-0.1|0.1||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 42: Suicide||0.1|-0.1|0.6087
72466908|NCT03672175|144457335|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.05||0.9791|TWO_SIDED|95.0|-0.1|0.1||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 42: Suicide||0.1|-0.1|0.9791
72466909|NCT03672175|144457335|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.1||0.2093|TWO_SIDED|95.0|-0.3|0.1||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15: Insomnia Early - Early Night||0.1|-0.3|0.2093
72466910|NCT03672175|144457335|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.1||0.5189|TWO_SIDED|95.0|-0.3|0.1||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15: Insomnia Early - Early Night||0.1|-0.3|0.5189
72466911|NCT03672175|144457335|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.1||0.6617|TWO_SIDED|95.0|-0.2|0.2||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 42: Insomnia Early - Early Night||0.2|-0.2|0.6617
72466912|NCT03672175|144457335|SUPERIORITY||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.1||0.2632|TWO_SIDED|95.0|-0.1|0.3||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 42: Insomnia Early - Early Night||0.3|-0.1|0.2632
72466913|NCT03672175|144457335|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.09||0.274|TWO_SIDED|95.0|-0.3|0.1||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15: Insomnia Middle - Middle Night||0.1|-0.3|0.2740
72466914|NCT03672175|144457335|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.09||0.1185|TWO_SIDED|95.0|-0.3|0.0||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15: Insomnia Middle - Middle Night||0.0|-0.3|0.1185
72466915|NCT03672175|144457335|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.1||0.945|TWO_SIDED|95.0|-0.2|0.2||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 42: Insomnia Middle - Middle Night||0.2|-0.2|0.9450
72466916|NCT03672175|144457335|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.09||0.6343|TWO_SIDED|95.0|-0.2|0.1||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 42: Insomnia Middle - Middle Night||0.1|-0.2|0.6343
72394564|NCT02310568|144295791|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|1.81||0.67|TWO_SIDED|90.0|-3.8|2.2|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - Placebo). Week 2: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1.||2.2|-3.8|0.670
72466917|NCT03672175|144457335|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.09||0.3169|TWO_SIDED|95.0|-0.3|0.1||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15: Insomnia Early Hours - Morning||0.1|-0.3|0.3169
72466918|NCT03672175|144457335|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.09||0.0178|TWO_SIDED|95.0|-0.4|0.0||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15: Insomnia Early Hours - Morning||0.0|-0.4|0.0178
72466919|NCT03672175|144457335|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.1||0.8504|TWO_SIDED|95.0|-0.2|0.2||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 42: Insomnia Early Hours - Morning||0.2|-0.2|0.8504
72466920|NCT03672175|144457335|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.1||0.5647|TWO_SIDED|95.0|-0.2|0.1||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 42: Insomnia Early Hours - Morning||0.1|-0.2|0.5647
72466921|NCT03672175|144457335|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.14||0.5914|TWO_SIDED|95.0|-0.3|0.2||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15: Work and Activities||0.2|-0.3|0.5914
72466922|NCT03672175|144457335|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.14||0.4603|TWO_SIDED|95.0|-0.4|0.2||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15: Work and Activities||0.2|-0.4|0.4603
72466923|NCT03672175|144457335|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.15||0.5637|TWO_SIDED|95.0|-0.4|0.2||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 42: Work and Activities||0.2|-0.4|0.5637
72466924|NCT03672175|144457335|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.14||0.4638|TWO_SIDED|95.0|-0.4|0.2||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 42: Work and Activities||0.2|-0.4|0.4638
72466925|NCT03672175|144457335|SUPERIORITY||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.07||0.1846|TWO_SIDED|95.0|0.0|0.2||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15: Retardation||0.2|0.0|0.1846
72466926|NCT03672175|144457335|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.06||0.4837|TWO_SIDED|95.0|-0.1|0.2||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15: Retardation||0.2|-0.1|0.4837
72466927|NCT03672175|144457335|SUPERIORITY||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.07||0.1178|TWO_SIDED|95.0|0.0|0.2||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 42: Retardation||0.2|0.0|0.1178
72466928|NCT03672175|144457335|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.06||0.7888|TWO_SIDED|95.0|-0.1|0.1||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 42: Retardation||0.1|-0.1|0.7888
72466929|NCT03672175|144457335|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.07||0.9496|TWO_SIDED|95.0|-0.1|0.1||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15: Agitation||0.1|-0.1|0.9496
72466930|NCT03672175|144457335|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.07||0.0497|TWO_SIDED|95.0|-0.3|0.0||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15: Agitation||0.0|-0.3|0.0497
72466931|NCT03672175|144457335|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.08||0.4189|TWO_SIDED|95.0|-0.2|0.1||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 42: Agitation||0.1|-0.2|0.4189
72466932|NCT03672175|144457335|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.08||0.1342|TWO_SIDED|95.0|-0.3|0.0||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 42: Agitation||0.0|-0.3|0.1342
72503614|NCT04800315|144538250|OTHER|Risk Difference|Difference VS Placebo|26.7||||0.006|TWO_SIDED|95.0|9.3|44.0|||Cochran-Mantel-Haenszel|||||44.0|9.3|0.006
72503615|NCT04800315|144538251|OTHER|Risk Difference|Risk Difference|18.1|||||TWO_SIDED|95.0|2.3|33.9|||Cochran-Mantel-Haenszel|||||33.9|2.3|
72503616|NCT04800315|144538251|OTHER|Risk Difference|Risk Difference|10.5|||||TWO_SIDED|95.0|-4.6|25.7|||Cochran-Mantel-Haenszel|||||25.7|-4.6|
72503617|NCT04800315|144538251|SUPERIORITY||Risk Difference|15.9|||||TWO_SIDED|95.0|0.4|31.4|||Cochran-Mantel-Haenszel|||||31.4|0.4|
72503618|NCT04800315|144538252|SUPERIORITY||Mean Difference (Final Values)|-28.16|||||TWO_SIDED|95.0|-41.89|-14.44|||ANCOVA|||||-14.44|-41.89|
72503619|NCT04800315|144538252|SUPERIORITY||Mean Difference (Final Values)|-14.36|||||TWO_SIDED|95.0|-27.26|-1.46|||ANCOVA|||||-1.46|-27.26|
72466933|NCT03672175|144457335|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.12||0.9202|TWO_SIDED|95.0|-0.3|0.2||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15: Anxiety Psychic||0.2|-0.3|0.9202
72466934|NCT03672175|144457335|SUPERIORITY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.12||0.026|TWO_SIDED|95.0|-0.5|0.0||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15: Anxiety Psychic||0.0|-0.5|0.0260
72466935|NCT03672175|144457335|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.13||0.937|TWO_SIDED|95.0|-0.3|0.2||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 42: Anxiety Psychic||0.2|-0.3|0.9370
72466936|NCT03672175|144457335|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.13||0.844|TWO_SIDED|95.0|-0.3|0.2||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 42: Anxiety Psychic||0.2|-0.3|0.8440
72466937|NCT03672175|144457335|SUPERIORITY||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.09||0.448|TWO_SIDED|95.0|-0.1|0.3||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15: Anxiety Somatic||0.3|-0.1|0.4480
72466938|NCT03672175|144457335|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.09||0.6345|TWO_SIDED|95.0|-0.1|0.2||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15: Anxiety Somatic||0.2|-0.1|0.6345
72466939|NCT03672175|144457335|SUPERIORITY||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.1||0.4123|TWO_SIDED|95.0|-0.1|0.3||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 42: Anxiety Somatic||0.3|-0.1|0.4123
72466940|NCT03672175|144457335|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.1||0.7523|TWO_SIDED|95.0|-0.2|0.2||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 42: Anxiety Somatic||0.2|-0.2|0.7523
72466941|NCT03672175|144457335|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.09||0.6505|TWO_SIDED|95.0|-0.2|0.1||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15: Somatic Symptoms Gastrointestinal||0.1|-0.2|0.6505
72394565|NCT02310568|144295791|SUPERIORITY_OR_OTHER||LS Mean Difference|0.6|STANDARD_ERROR_OF_MEAN|1.74||0.736|TWO_SIDED|90.0|-2.3|3.5|||Mixed-Effects Model Repeated Measure|||(PF-06372865 2.5 mg - Placebo). Week 2: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1.||3.5|-2.3|0.736
72394566|NCT02310568|144295791|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.4|STANDARD_ERROR_OF_MEAN|1.99||0.496|TWO_SIDED|90.0|-4.7|2.0|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 2: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1.||2.0|-4.7|0.496
72466942|NCT03672175|144457335|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.09||0.3674|TWO_SIDED|95.0|-0.3|0.1||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15: Somatic Symptoms Gastrointestinal||0.1|-0.3|0.3674
72466943|NCT03672175|144457335|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.09||0.836|TWO_SIDED|95.0|-0.2|0.2||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 42: Somatic Symptoms Gastrointestinal||0.2|-0.2|0.8360
72466944|NCT03672175|144457335|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.09||0.687|TWO_SIDED|95.0|-0.2|0.1||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 42: Somatic Symptoms Gastrointestinal||0.1|-0.2|0.6870
72466945|NCT03672175|144457335|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.08||0.1364|TWO_SIDED|95.0|-0.3|0.0||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15: General Somatic Symptoms||0.0|-0.3|0.1364
72466946|NCT03672175|144457335|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.09||0.1578|TWO_SIDED|95.0|-0.3|0.0||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15: General Somatic Symptoms||0.0|-0.3|0.1578
72466947|NCT03672175|144457335|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.09||0.9062|TWO_SIDED|95.0|-0.2|0.2||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 42: General Somatic Symptoms||0.2|-0.2|0.9062
72466948|NCT03672175|144457335|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.09||0.8596|TWO_SIDED|95.0|-0.2|0.2||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 42: General Somatic Symptoms||0.2|-0.2|0.8596
72466949|NCT03672175|144457335|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.09||0.9488|TWO_SIDED|95.0|-0.2|0.2||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15: Genital Symptoms||0.2|-0.2|0.9488
72466950|NCT03672175|144457335|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.09||0.1514|TWO_SIDED|95.0|-0.3|0.0||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15: Genital Symptoms||0.0|-0.3|0.1514
72466951|NCT03672175|144457335|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.09||0.5796|TWO_SIDED|95.0|-0.2|0.1||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 42: Genital Symptoms||0.1|-0.2|0.5796
72466952|NCT03672175|144457335|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.1||0.4739|TWO_SIDED|95.0|-0.3|0.1||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 42: Genital Symptoms||0.1|-0.3|0.4739
72466953|NCT03672175|144457335|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.07||0.9439|TWO_SIDED|95.0|-0.1|0.1||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15: Hypochondriasis||0.1|-0.1|0.9439
72466954|NCT03672175|144457335|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.07||0.3891|TWO_SIDED|95.0|-0.2|0.1||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15: Hypochondriasis||0.1|-0.2|0.3891
72466955|NCT03672175|144457335|SUPERIORITY||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.07||0.0308|TWO_SIDED|95.0|0.0|0.3||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 42: Hypochondriasis||0.3|0.0|0.0308
72466956|NCT03672175|144457335|SUPERIORITY||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.07||0.062|TWO_SIDED|95.0|0.0|0.3||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 42: Hypochondriasis||0.3|0.0|0.0620
72466957|NCT03672175|144457335|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.07||0.7744|TWO_SIDED|95.0|-0.2|0.1||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15: Loss of Weight||0.1|-0.2|0.7744
72466958|NCT03672175|144457335|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.08||0.9312|TWO_SIDED|95.0|-0.1|0.2||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15: Loss of Weight||0.2|-0.1|0.9312
72564714|NCT04019054|144660978|SUPERIORITY|||||||0.029||||||a priori threshold for significance of 0.05|Mixed Models Analysis|||The second statistical analysis involved testing of the step-by-timepoint interaction in the two-variable negative binomial model of skin conductance level (SCL) (as a function of step and timepoint).||||0.029
72466959|NCT03672175|144457335|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.08||0.3105|TWO_SIDED|95.0|-0.2|0.1||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 42: Loss of Weight||0.1|-0.2|0.3105
72466960|NCT03672175|144457335|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.08||0.8406|TWO_SIDED|95.0|-0.1|0.2||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 42: Loss of Weight||0.2|-0.1|0.8406
72466961|NCT03672175|144457335|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.03||0.4834|TWO_SIDED|95.0|-0.1|0.0||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15: Insight||0.0|-0.1|0.4834
72466962|NCT03672175|144457335|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.02||0.0961|TWO_SIDED|95.0|-0.1|0.0||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15: Insight||0.0|-0.1|0.0961
72466963|NCT03672175|144457335|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.02||0.829|TWO_SIDED|95.0|0.0|0.0||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 42: Insight||0.0|0.0|0.8290
72466964|NCT03672175|144457335|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.02||0.9546|TWO_SIDED|95.0|0.0|0.0||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 42: Insight||0.0|0.0|0.9546
72466965|NCT03672175|144457336|SUPERIORITY||LS Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|0.78||0.1308|TWO_SIDED|95.0|-2.7|0.4||MMRM with treatment, BL ISI total score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15||0.4|-2.7|0.1308
72466966|NCT03672175|144457336|SUPERIORITY||LS Mean Difference|-2.0|STANDARD_ERROR_OF_MEAN|0.77||0.0096|TWO_SIDED|95.0|-3.5|-0.5||MMRM with treatment, BL ISI total score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15||-0.5|-3.5|0.0096
72466967|NCT03672175|144457336|SUPERIORITY||LS Mean Difference|1.0|STANDARD_ERROR_OF_MEAN|0.86||0.2674|TWO_SIDED|95.0|-0.7|2.7||MMRM with treatment, BL ISI total score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 42||2.7|-0.7|0.2674
72466968|NCT03672175|144457336|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.87||0.9771|TWO_SIDED|95.0|-1.7|1.7||MMRM with treatment, BL ISI total score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 42||1.7|-1.7|0.9771
72564715|NCT04019054|144660979|OTHER|This was a goodness of fit test of a multi-level model, fit was tested using a wald chi-square test.|||||<|0.001||||||a priori threshold for significance was p=0.05.|Chi-squared|This was specifically a wald chi-square test, performed in Stata for the purpose of assessing goodness-of-fit of a mixed effects model||Goodness of fit test of a two-variable negative binomial multi-level model of anticipatory distress as a function of step and timepoint. This multi-level model was generated using the menbreg function in Stata 16||||<0.001
72564716|NCT04019054|144660979|SUPERIORITY|||||||0.63||||||a priori threshold for significance of 0.05|Mixed Models Analysis|||This statistical analysis involved testing of the step-by-timepoint interaction in the two-variable negative binomial model of anticipatory distress as a function of step and timepoint.||||0.63
72466969|NCT03672175|144457337|SUPERIORITY||LS Mean Difference|-2.2|STANDARD_ERROR_OF_MEAN|4.42||0.611|TWO_SIDED|95.0|-10.9|6.4||MMRM with treatment, BL sSL score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15: sSL||6.4|-10.9|0.6110
72503620|NCT04800315|144538252|SUPERIORITY||Mean Difference (Final Values)|-19.07|||||TWO_SIDED|95.0|-33.53|-4.62|||ANCOVA|||||-4.62|-33.53|
72503621|NCT04800315|144538253|OTHER|Adjusted Mean Difference VS Placebo|Adjusted Mean Difference VS Placebo|-22.5|||||TWO_SIDED|95.0|-41.46|-3.54|||ANCOVA|||||-3.54|-41.46|
72503622|NCT04800315|144538253|OTHER|Adjusted Mean Difference VS Placebo|Adjusted Mean Difference VS Placebo|-13.17|||||TWO_SIDED|95.0|-30.67|4.33|||ANCOVA|||||4.33|-30.67|
72503623|NCT04800315|144538253|OTHER|Adjusted Mean Difference VS Placebo|Adjusted Mean Difference VS Placebo|-16.32|||||TWO_SIDED|95.0|-36.4|3.75|||ANCOVA|||||3.75|-36.40|
72503624|NCT04800315|144538254|OTHER|Risk Difference VS Placebo|Risk Difference VS Placebo|18.5||||0.042|TWO_SIDED|95.0|2.7|34.3|||Cochran-Mantel-Haenszel|||||34.3|2.7|0.042
72503625|NCT04800315|144538254|OTHER|Risk Difference VS Placebo|Risk Difference VS Placebo|19.9||||0.029|TWO_SIDED|95.0|4.1|35.7|||Cochran-Mantel-Haenszel|||||35.7|4.1|0.029
72503626|NCT04800315|144538254|OTHER|Risk Difference VS Placebo|Risk Difference VS Placebo|18.0||||0.052|TWO_SIDED|95.0|2.3|33.6|||Cochran-Mantel-Haenszel|||||33.6|2.3|0.052
72503627|NCT04800315|144538256|OTHER|Adjusted mean difference VS Placebo|Adjusted mean difference VS Placebo|-23.12|||||TWO_SIDED|95.0|-41.48|-4.76|||ANCOVA|||||-4.76|-41.48|
72503628|NCT04800315|144538256|OTHER|Adjusted mean difference VS Placebo|Adjusted mean difference VS Placebo|-8.28|||||TWO_SIDED|95.0|-25.16|8.59|||ANCOVA|||||8.59|-25.16|
72503629|NCT04800315|144538256|OTHER|Adjusted mean difference VS Placebo|Adjusted mean difference VS Placebo|-10.87|||||TWO_SIDED|95.0|-29.39|7.66|||ANCOVA|||||7.66|-29.39|
72466970|NCT03672175|144457337|SUPERIORITY||LS Mean Difference|-8.0|STANDARD_ERROR_OF_MEAN|4.19||0.0581|TWO_SIDED|95.0|-16.2|0.3||MMRM with treatment, BL sSL score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15: sSL||0.3|-16.2|0.0581
72466971|NCT03672175|144457337|SUPERIORITY||LS Mean Difference|-4.3|STANDARD_ERROR_OF_MEAN|5.68||0.4493|TWO_SIDED|95.0|-15.5|6.9||MMRM with treatment, BL sSL score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 28: sSL||6.9|-15.5|0.4493
72466972|NCT03672175|144457337|SUPERIORITY||LS Mean Difference|-3.7|STANDARD_ERROR_OF_MEAN|6.25||0.5587|TWO_SIDED|95.0|-16.0|8.6||MMRM with treatment, BL sSL score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 28: sSL||8.6|-16.0|0.5587
72503630|NCT00524303|144538307|SUPERIORITY_OR_OTHER||Percent difference|-9.0|||||TWO_SIDED|95.0|-38.1|17.9|||||Approximate 95% confidence interval for the difference in response rates between the trastuzumab arm and the lapatinib arm was calculated.|||17.9|-38.1|
72503631|NCT00524303|144538307|SUPERIORITY_OR_OTHER||Percent difference|20.0|||||TWO_SIDED|95.0|-8.0|49.4|||||Approximate 95% confidence interval for the difference in response rates between the transtuzumab arm and the transtuzumab + lapatinib arm was calculated.|||49.4|-8.0|
72503632|NCT00524303|144538308|SUPERIORITY_OR_OTHER||Percent Difference|7.0||||0.627|TWO_SIDED|95.0|-17.8|32.5|||Fisher Exact||Approximate 95% confidence interval for the difference in response rates between the transtuzumab arm and the lapatinib arm was calculated.|||32.5|-17.8|0.627
72503633|NCT00524303|144538308|SUPERIORITY_OR_OTHER||Percent Difference|0.0||||1|TWO_SIDED|95.0|-25.1|25.1|||Fisher Exact||Approximate 95% confidence interval for the difference in response rates between the transtuzumab arm and the transtuzumab + lapatinib arm was calculated.|||25.1|-25.1|1.000
72503634|NCT01676116|144538372|SUPERIORITY_OR_OTHER||Treatment contrast|-0.94|||<|0.001|TWO_SIDED|95.0|-1.11|-0.78|||ANCOVA|||||-0.78|-1.11|<0.001
72503635|NCT01287117|144538381|SUPERIORITY_OR_OTHER||Least squares mean difference|-2.96||||0.001|TWO_SIDED|95.0|-4.71|-1.21||A multiplicity type I error control plan was employed to adjust for the comparison of multiple omalizumab groups to the placebo group in order to maintain an overall type I error rate of 0.05 (2-sided).|ANCOVA|Covariates included in the analysis were baseline weekly itch severity score (\< 13 vs ≥ 13) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis was that there was no difference between the placebo and the omalizumab 75 mg groups.||-1.21|-4.71|0.0010
72503636|NCT01287117|144538381|SUPERIORITY_OR_OTHER||Least squares mean difference|-2.95||||0.0012|TWO_SIDED|95.0|-4.72|-1.18||A multiplicity type I error control plan was employed to adjust for the comparison of multiple omalizumab groups to the placebo group in order to maintain an overall type I error rate of 0.05 (2-sided).|ANCOVA|Covariates included in the analysis were baseline weekly itch severity score (\< 13 vs ≥ 13) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis was that there was no difference between the placebo and the omalizumab 150 mg groups.||-1.18|-4.72|0.0012
72503637|NCT01287117|144538381|SUPERIORITY_OR_OTHER||Least squares mean difference|-5.8|||<|0.0001|TWO_SIDED|95.0|-7.49|-4.1||A multiplicity type I error control plan was employed to adjust for the comparison of multiple omalizumab groups to the placebo group in order to maintain an overall type I error rate of 0.05 (2-sided).|ANCOVA|Covariates included in the analysis were baseline weekly itch severity score (\< 13 vs ≥ 13) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis was that there was no difference between the placebo and the omalizumab 300 mg groups.||-4.10|-7.49|<0.0001
72621767|NCT01197300|144773942|SUPERIORITY|Difference in least squares mean = LS mean for the Core treatment Zoledronic acid group - LS mean for the Core treatment Placebo group.|Difference in LS mean|1.179||||0.705|TWO_SIDED|95.0|-5.281|7.639||An analysis of covariance (ANCOVA) model was performed with Core treatment, pooled centers, underlying condition treated with GCs and Core baseline lumbar spine BMD Z-score as explanatory variables and pooled centers as random effect.|ANCOVA|||Lumbar Spine BMC Change at Month 24||7.639|-5.281|0.7050
72621768|NCT01197300|144773943|SUPERIORITY|Difference in least squares mean = LS mean for the Core treatment Zoledronic acid group - LS mean for the Core treatment Placebo group.|Difference in LS mean|121.129||||0.531|TWO_SIDED|95.0|-291.0|533.258||An analysis of covariance (ANCOVA) model was performed with Core treatment, pooled centers, underlying condition treated with GCs and Core baseline lumbar spine BMD Z-score as explanatory variables and pooled centers as random effect.|ANCOVA|||Total body BMC Change at Month 18||533.258|-291.000|0.5310
72466973|NCT03672175|144457337|SUPERIORITY||LS Mean Difference|-2.1|STANDARD_ERROR_OF_MEAN|4.06||0.5976|TWO_SIDED|95.0|-10.1|5.8||MMRM with treatment, BL sWASO score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15: sWASO||5.8|-10.1|0.5976
72466974|NCT03672175|144457337|SUPERIORITY||LS Mean Difference|0.4|STANDARD_ERROR_OF_MEAN|5.05||0.9421|TWO_SIDED|95.0|-9.6|10.3||MMRM with treatment, BL sWASO score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15: sWASO||10.3|-9.6|0.9421
72466975|NCT03672175|144457337|SUPERIORITY||LS Mean Difference|2.9|STANDARD_ERROR_OF_MEAN|4.86||0.5581|TWO_SIDED|95.0|-6.7|12.4||MMRM with treatment, BL sWASO score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 28: sWASO||12.4|-6.7|0.5581
72466976|NCT03672175|144457337|SUPERIORITY||LS Mean Difference|3.9|STANDARD_ERROR_OF_MEAN|5.82||0.4997|TWO_SIDED|95.0|-7.5|15.4||MMRM with treatment, BL sWASO score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 28: sWASO||15.4|-7.5|0.4997
72466977|NCT03672175|144457337|SUPERIORITY||LS Mean Difference|24.0|STANDARD_ERROR_OF_MEAN|10.5||0.0224|TWO_SIDED|95.0|3.4|44.7||MMRM with treatment, BL sTST score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15: sTST||44.7|3.4|0.0224
72466978|NCT03672175|144457337|SUPERIORITY||LS Mean Difference|17.4|STANDARD_ERROR_OF_MEAN|10.93||0.1117|TWO_SIDED|95.0|-4.1|38.9||MMRM with treatment, BL sTST score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15: sTST||38.9|-4.1|0.1117
72503638|NCT01287117|144538382|SUPERIORITY_OR_OTHER||Least squares mean difference|-5.75||||0.0035|TWO_SIDED|95.0|-9.59|-1.92||A pre-specified hierarchical order of testing was employed to adjust for the comparison of multiple omalizumab groups to the placebo group in order to maintain an overall type I error rate of 0.05 (2-sided) within each dose.|ANCOVA|Covariates included in the analysis were baseline UAS7 (\< median vs ≥ median) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis was that there was no difference between the placebo and the omalizumab 75 mg groups.||-1.92|-9.59|0.0035
72503639|NCT01287117|144538382|SUPERIORITY_OR_OTHER||Least squares mean difference|-6.54||||0.0008|TWO_SIDED|95.0|-10.33|-2.75||A pre-specified hierarchical order of testing was employed to adjust for the comparison of multiple omalizumab groups to the placebo group in order to maintain an overall type I error rate of 0.05 (2-sided) within each dose.|ANCOVA|Covariates included in the analysis were baseline UAS7 (\< median vs ≥ median) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis was that there was no difference between the placebo and the omalizumab 150 mg groups.||-2.75|-10.33|0.0008
72504844|NCT03551522|144540604|OTHER|The LS Means, confidence intervals, and p-values come from an ANCOVA model with relative (percent) change from baseline as the dependent variable and treatment and stratification groups (diabetic status and fibrosis stage) as factors and baseline as a covariate.|LS Mean of Difference|11.02||||0.0874|TWO_SIDED|95.0|-1.63|23.67|||ANCOVA|||||23.67|-1.63|0.0874
72466979|NCT03672175|144457337|SUPERIORITY||LS Mean Difference|14.1|STANDARD_ERROR_OF_MEAN|14.18||0.3208|TWO_SIDED|95.0|-13.8|42.0||MMRM with treatment, BL sTST score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 28: sTST||42.0|-13.8|0.3208
72466980|NCT03672175|144457337|SUPERIORITY||LS Mean Difference|10.3|STANDARD_ERROR_OF_MEAN|13.4||0.444|TWO_SIDED|95.0|-16.1|36.6||MMRM with treatment, BL sTST score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 28: sTST||36.6|-16.1|0.4440
72466981|NCT03672175|144457338|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.1||0.4737|TWO_SIDED|95.0|-0.3|0.1||MMRM with treatment, BL sNAW score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15||0.1|-0.3|0.4737
72466982|NCT03672175|144457338|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.1||0.0138|TWO_SIDED|95.0|-0.4|0.0||MMRM with treatment, BL sNAW score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15||0.0|-0.4|0.0138
72466983|NCT03672175|144457338|SUPERIORITY||LS Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|0.12||0.1098|TWO_SIDED|95.0|0.0|0.4||MMRM with treatment, BL sNAW score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 28||0.4|0.0|0.1098
72466984|NCT03672175|144457338|SUPERIORITY||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.11||0.6234|TWO_SIDED|95.0|-0.2|0.3||MMRM with treatment, BL sNAW score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 28||0.3|-0.2|0.6234
72466985|NCT03672175|144457339|SUPERIORITY||Odds Ratio (OR)|0.89||||0.6741|TWO_SIDED|95.0|0.52|1.53||GEE for binary response model, with factors for treatment, BL sleep quality response, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction were used for analysis.|GEE|||Day 15||1.53|0.52|0.6741
72466986|NCT03672175|144457339|SUPERIORITY||Odds Ratio (OR)|0.79||||0.3924|TWO_SIDED|95.0|0.46|1.36||GEE for binary response model, with factors for treatment, BL sleep quality response, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction were used for analysis.|GEE|||Day 15||1.36|0.46|0.3924
72466987|NCT03672175|144457339|SUPERIORITY||Odds Ratio (OR)|0.9||||0.7307|TWO_SIDED|95.0|0.51|1.6||GEE for binary response model, with factors for treatment, BL sleep quality response, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction were used for analysis.|GEE|||Day 28||1.60|0.51|0.7307
72466988|NCT03672175|144457339|SUPERIORITY||Odds Ratio (OR)|0.94||||0.8358|TWO_SIDED|95.0|0.52|1.7||GEE for binary response model, with factors for treatment, BL sleep quality response, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction were used for analysis.|GEE|||Day 28||1.70|0.52|0.8358
72466989|NCT03672175|144457340|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.72||0.7375|TWO_SIDED|95.0|-1.6|1.2||MMRM with treatment, BL SF-36v2 physical component score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15: PCS Score||1.2|-1.6|0.7375
72466990|NCT03672175|144457340|SUPERIORITY||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.74||0.5144|TWO_SIDED|95.0|-1.9|1.0||MMRM with treatment, BL SF-36v2 physical component score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15: PCS Score||1.0|-1.9|0.5144
72466991|NCT03672175|144457340|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.79||0.8343|TWO_SIDED|95.0|-1.7|1.4||MMRM with treatment, BL SF-36v2 physical component score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 42: PCS Score||1.4|-1.7|0.8343
72466992|NCT03672175|144457340|SUPERIORITY||LS Mean Difference|0.6|STANDARD_ERROR_OF_MEAN|0.85||0.4569|TWO_SIDED|95.0|-1.0|2.3||MMRM with treatment, BL SF-36v2 physical component score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 42: PCS Score||2.3|-1.0|0.4569
72466993|NCT03672175|144457340|SUPERIORITY||LS Mean Difference|1.2|STANDARD_ERROR_OF_MEAN|1.63||0.4663|TWO_SIDED|95.0|-2.0|4.4||MMRM with treatment, BL SF-36v2 mental component score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15: MCS Score||4.4|-2.0|0.4663
72466994|NCT03672175|144457340|SUPERIORITY||LS Mean Difference|2.7|STANDARD_ERROR_OF_MEAN|1.68||0.1138|TWO_SIDED|95.0|-0.6|6.0||MMRM with treatment, BL SF-36v2 mental component score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15: MCS Score||6.0|-0.6|0.1138
72466995|NCT03672175|144457340|SUPERIORITY||LS Mean Difference|0.5|STANDARD_ERROR_OF_MEAN|1.74||0.7901|TWO_SIDED|95.0|-3.0|3.9||MMRM with treatment, BL SF-36v2 mental component score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 42: MCS Score||3.9|-3.0|0.7901
72466996|NCT03672175|144457340|SUPERIORITY||LS Mean Difference|1.5|STANDARD_ERROR_OF_MEAN|1.71||0.3955|TWO_SIDED|95.0|-1.9|4.8||MMRM with treatment, BL SF-36v2 mental component score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 42: MCS Score||4.8|-1.9|0.3955
72466997|NCT03672175|144457341|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.83||0.8821|TWO_SIDED|95.0|-1.8|1.5||MMRM with treatment, BL PHQ-9 total score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction were used for analysis.|MMRM|||Day 15||1.5|-1.8|0.8821
72466998|NCT03672175|144457341|SUPERIORITY||LS Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|0.83||0.151|TWO_SIDED|95.0|-2.8|0.4||MMRM with treatment, BL PHQ-9 total score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction were used for analysis.|MMRM|||Day 15||0.4|-2.8|0.1510
72503640|NCT01287117|144538382|SUPERIORITY_OR_OTHER||Least squares mean difference|-12.8|||<|0.0001|TWO_SIDED|95.0|-16.44|-9.16||A pre-specified hierarchical order of testing was employed to adjust for the comparison of multiple omalizumab groups to the placebo group in order to maintain an overall type I error rate of 0.05 (2-sided) within each dose.|ANCOVA|Covariates included in the analysis were baseline UAS7 (\< median vs ≥ median) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis was that there was no difference between the placebo and the omalizumab 300 mg groups.||-9.16|-16.44|<0.0001
72466999|NCT03672175|144457341|SUPERIORITY||LS Mean Difference|0.9|STANDARD_ERROR_OF_MEAN|0.84||0.2926|TWO_SIDED|95.0|-0.8|2.5||MMRM with treatment, BL PHQ-9 total score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction were used for analysis.|MMRM|||Day 42||2.5|-0.8|0.2926
72467000|NCT03672175|144457341|SUPERIORITY||LS Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.83||0.4785|TWO_SIDED|95.0|-2.2|1.0||MMRM with treatment, BL PHQ-9 total score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction were used for analysis.|MMRM|||Day 42||1.0|-2.2|0.4785
72467001|NCT01163955|144457363|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.8|STANDARD_DEVIATION|1.92|<|0.0005|TWO_SIDED|95.0|0.0|9.0|||t-test, 2 sided|DF=50||Start total score at 0 minutes is being compared to the end total score at 5 minutes while sitting in the floor.||9|0|<.0005
72467002|NCT01163955|144457363|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.7|STANDARD_DEVIATION|1.99|<|0.0005|TWO_SIDED|95.0|0.0|9.0|||t-test, 2 sided|DF=50||Start total score at 0 minutes is being compared to the end total score at 5 minutes while sitting in a chair.||9|0|<.0005
72467003|NCT02586415|144457406|SUPERIORITY||Odds Ratio (OR)|2.77|||<|0.001|TWO_SIDED|95.0|1.63|4.7||Criteria to assess superiority was a two-sided P value of \<0.05. The study was terminated early because the pre-specified stopping boundary of P \<0.0025 was crossed at the first interim analysis (N=182)|Cochran-Mantel-Haenszel|||||4.70|1.63|<0.001
72467004|NCT01898442|144457441|SUPERIORITY_OR_OTHER|||||||0.017|TWO_SIDED||||||ANCOVA|||||||0.017
72467005|NCT05178979|144457447|SUPERIORITY||Wald Chi-Square|1.94||||0.38|TWO_SIDED|||||Models control for clinic, gender, lifetime experience of intimate partner violence (IPV) and are adjusted for multiple time points. Models run using generalized estimating equations (GEE) to account for dependence in repeated, clustered data.|Regression, Linear||Wald Chi-Square tests the overall arm\*time intervention effect across the timepoints|||||0.38
72621769|NCT01197300|144773943|SUPERIORITY|Difference in least squares mean = LS mean for the Core treatment Zoledronic acid group - LS mean for the Core treatment Placebo group.|Difference in LS mean|65.674||||0.7347|TWO_SIDED|95.0|-344.067|475.415||An analysis of covariance (ANCOVA) model was performed with Core treatment, pooled centers, underlying condition treated with GCs and Core baseline lumbar spine BMD Z-score as explanatory variables and pooled centers as random effect.|ANCOVA|||Total body BMC Change at Month 24||475.415|-344.067|0.7347
72467006|NCT05178979|144457447|SUPERIORITY||unstandardized beta|0.93|STANDARD_ERROR_OF_MEAN|4.63||0.84|TWO_SIDED|||||P-value is adjusted for multiple comparisons; this value is for the 6-month follow-up|Regression, Linear|Models control for clinic, gender, lifetime experience of intimate partner violence (IPV) and are adjusted for multiple time points.||Models run using generalized estimating equations (GEE) to account for dependence in repeated, clustered data.||||0.84
72467007|NCT05178979|144457447|SUPERIORITY||unstandardized beta|-2.62|STANDARD_ERROR_OF_MEAN|3.87||0.5|TWO_SIDED|||||P-value is adjusted for multiple comparisons; this value is for the 12-month follow-up|Regression, Linear|Models control for clinic, gender, lifetime experience of intimate partner violence (IPV) and are adjusted for multiple time points.||Models run using generalized estimating equations (GEE) to account for dependence in repeated, clustered data.||||0.50
72467008|NCT05178979|144457448|SUPERIORITY||Wald Chi-square|2.0||||0.37|TWO_SIDED|||||Models control for clinic and are adjusted for multiple time points. Models run using generalized estimating equations (GEE) to account for dependence in repeated, clustered data.|Regression, Linear||Wald Chi-Square tests the overall arm\*time intervention effect across the timepoints|||||0.37
72467009|NCT05178979|144457448|SUPERIORITY||unstandardized beta|-0.02|STANDARD_ERROR_OF_MEAN|0.01||0.18|TWO_SIDED|||||P-value is adjusted for clinic; this value is the 6-month follow-up|Regression, Linear|Model controls for clinic||Models run using generalized estimating equations (GEE) to account for dependence in repeated, clustered data.||||0.18
72467010|NCT05178979|144457448|SUPERIORITY||unstandardized beta|-0.03|STANDARD_ERROR_OF_MEAN|0.02||0.19|TWO_SIDED|||||P-value is adjusted for clinic; this value is the 12-month follow-up|Regression, Linear|Model controls for clinic|Wald Chi-Square tests the overall arm\*time intervention effect across the timepoints|Models run using generalized estimating equations (GEE) to account for dependence in repeated, clustered data.||||0.19
72467011|NCT05178979|144457449|SUPERIORITY||Wald Chi-square|10.84||||0.004|TWO_SIDED|||||Models control for clinic, cadre, and gender and are adjusted for multiple time points. Models run using generalized estimating equations (GEE) to account for dependence in repeated, clustered data.|Regression, Linear||Wald Chi-Square tests the overall arm\*time intervention effect across the timepoints|||||0.004
72467012|NCT05178979|144457449|SUPERIORITY||unstandardized beta|0.24|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|||||P-value is adjusted for multiple comparisons; this value is for the 6-month follow-up|Regression, Linear|Models control for clinic, cadre, and gender and are adjusted for multiple time points.||||||<0.001
72467013|NCT05178979|144457449|SUPERIORITY||unstandardized beta|-0.02|STANDARD_ERROR_OF_MEAN|0.09||0.86|TWO_SIDED|||||P-value is adjusted for multiple comparisons; this value is for the 12-month follow-up|Regression, Linear|Models control for clinic, cadre, and gender and are adjusted for multiple time points.||||||0.86
72467014|NCT05178979|144457450|SUPERIORITY||Wald Chi-square|21.42|||<|0.001|TWO_SIDED|||||Models control for clinic, cadre, and gender and are adjusted for multiple time points. Models run using generalized estimating equations (GEE) to account for dependence in repeated, clustered data.|Regression, Logistic||Wald Chi-Square tests the overall arm\*time intervention effect across the timepoints|||||<0.001
72467015|NCT05178979|144457450|SUPERIORITY||unstandardized beta|0.04|STANDARD_ERROR_OF_MEAN|0.14||0.81|TWO_SIDED|||||P-value is adjusted for multiple comparisons; this value is for the 6-month follow-up.|Regression, Linear|Models control for clinic, cadre, and gender and are adjusted for multiple time points.||update||||0.81
72467016|NCT05178979|144457450|SUPERIORITY||unstandardized beta|-0.22|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|||||P-value is adjusted for multiple comparisons; this value is for the 12-month follow-up.|Regression, Linear|Models control for clinic, cadre, and gender and are adjusted for multiple time points.||update||||<0.001
72467017|NCT05178979|144457451|SUPERIORITY||Wald Chi-square|150.43|||<|0.001|TWO_SIDED|||||Models control for clinic, cadre, and gender and are adjusted for multiple time points. Models run using generalized estimating equations (GEE) to account for dependence in repeated, clustered data.|Regression, Linear||Wald Chi-Square tests the overall arm\*time intervention effect across the timepoints|||||<0.001
72467018|NCT05178979|144457451|SUPERIORITY||unstandardized beta|0.17|STANDARD_ERROR_OF_MEAN|0.05||0.002|TWO_SIDED|||||P-value is adjusted for multiple comparisons; this value is for the 6-month follow-up|Regression, Linear|||||||0.002
72503641|NCT01287117|144538383|SUPERIORITY_OR_OTHER||Least squares mean difference|-2.75||||0.0149|TWO_SIDED|95.0|-4.95|-0.54||A pre-specified hierarchical order of testing was employed to adjust for the comparison of multiple omalizumab groups to the placebo group in order to maintain an overall type I error rate of 0.05 (2-sided) within each dose.|ANCOVA|Covariates included in the analysis were baseline weekly number of hives score (\< median vs ≥ median) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis was that there was no difference between the placebo and the omalizumab 75 mg groups.||-0.54|-4.95|0.0149
72503642|NCT01287117|144538383|SUPERIORITY_OR_OTHER||Least squares mean difference|-3.44||||0.0017|TWO_SIDED|95.0|-5.57|-1.32||A pre-specified hierarchical order of testing was employed to adjust for the comparison of multiple omalizumab groups to the placebo group in order to maintain an overall type I error rate of 0.05 (2-sided) within each dose.|ANCOVA|Covariates included in the analysis were baseline weekly number of hives score (\< median vs ≥ median) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis was that there was no difference between the placebo and the omalizumab 150 mg groups.||-1.32|-5.57|0.0017
72503643|NCT01287117|144538383|SUPERIORITY_OR_OTHER||Least squares mean difference|-6.93|||<|0.0001|TWO_SIDED|95.0|-9.1|-4.76||A pre-specified hierarchical order of testing was employed to adjust for the comparison of multiple omalizumab groups to the placebo group in order to maintain an overall type I error rate of 0.05 (2-sided) within each dose.|ANCOVA|Covariates included in the analysis were baseline weekly number of hives score (\< median vs ≥ median) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis was that there was no difference between the placebo and the omalizumab 300 mg groups.||-4.76|-9.10|<0.0001
72467019|NCT05178979|144457451|SUPERIORITY||unstandardized beta|0.13|STANDARD_ERROR_OF_MEAN|0.06||0.03|TWO_SIDED|||||P-value is adjusted for multiple comparisons; this value is for the 12-month follow-up|Regression, Linear|||||||0.03
72467020|NCT05178979|144457452|SUPERIORITY||Wald Chi-square|8.72||||0.01|TWO_SIDED|||||Models control for clinic, cadre, and gender and are adjusted for multiple time points. Models run using generalized estimating equations (GEE) to account for dependence in repeated, clustered data.|Regression, Linear||Wald Chi-Square tests the overall arm\*time intervention effect across the timepoints|||||0.01
72467021|NCT05178979|144457452|SUPERIORITY||unstandardized beta|0.42|STANDARD_ERROR_OF_MEAN|0.29||0.15|TWO_SIDED|||||P-value is adjusted for multiple comparisons; this value is for the 6-month follow-up.|Regression, Linear|Models control for clinic, cadre, and gender and are adjusted for multiple time points.||||||0.15
72467022|NCT05178979|144457452|SUPERIORITY||unstandardized beta|0.32|STANDARD_ERROR_OF_MEAN|0.12||0.008|TWO_SIDED|||||P-value is adjusted for multiple comparisons; this value is for the 12-month follow-up.|Regression, Linear|Models control for clinic, cadre, and gender and are adjusted for multiple time points.||||||0.008
72467023|NCT05178979|144457453|SUPERIORITY||Wald Chi-square|172.52|||<|0.001|TWO_SIDED|||||Models control for clinic and income and are adjusted for multiple time points. Models run using generalized estimating equations (GEE) to account for dependence in repeated, clustered data.|Regression, Linear||Wald Chi-Square tests the overall arm\*time intervention effect across the timepoints|||||<0.001
72467024|NCT05178979|144457453|SUPERIORITY||unstandardized beta|0.14|STANDARD_ERROR_OF_MEAN|0.34||0.68|TWO_SIDED|||||P-value is adjusted for multiple comparisons; this value is the 6-month follow-up|Regression, Linear|Models control for clinic and income and are adjusted for multiple time points.||||||0.68
72467025|NCT05178979|144457453|SUPERIORITY||unstandardized beta|-0.83|STANDARD_ERROR_OF_MEAN|0.24|<|0.001|TWO_SIDED|||||P-value is adjusted for multiple comparisons; this value is for the 12-month follow-up.|Regression, Linear|Models control for clinic and income and are adjusted for multiple time points.||||||<0.001
72467026|NCT05178979|144457454|SUPERIORITY|Models control for clinic, income, years living with HIV and are adjusted for multiple time points. Models run using generalized estimating equations (GEE) to account for dependence in repeated, clustered data.|Wald Chi-square|25.27|||<|0.001|TWO_SIDED||||||Regression, Linear||Wald Chi-Square tests the overall arm\*time intervention effect across the timepoints|||||<0.001
72467027|NCT05178979|144457454|SUPERIORITY||unstandardized beta|-0.26|STANDARD_ERROR_OF_MEAN|0.16||0.1|TWO_SIDED|||||P-value is adjusted for multiple comparisons; this value is the 6-month follow-up.|Regression, Linear|Models control for clinic, income, years living with HIV and are adjusted for multiple time points.||||||0.10
72467028|NCT05178979|144457454|SUPERIORITY||unstandardized beta|0.08|STANDARD_ERROR_OF_MEAN|0.14||0.54|TWO_SIDED|||||P-value is adjusted for multiple comparisons; this value is the 12-month follow-up.|Regression, Linear|Models control for clinic, income, years living with HIV and are adjusted for multiple time points||||||0.54
72467029|NCT05178979|144457455|SUPERIORITY|Models control for clinic, gender, AUDIT score and are adjusted for multiple time points. Models run using generalized estimating equations (GEE) to account for dependence in repeated, clustered data.|Wald Chi-square|36.04|||<|0.001|TWO_SIDED|||||Models control for clinic, gender, AUDIT score and are adjusted for multiple time points.|Regression, Linear||Wald Chi-Square tests the overall arm\*time intervention effect across the timepoints|||||<0.001
72467030|NCT05178979|144457455|SUPERIORITY||unstandardized beta|0.0|STANDARD_ERROR_OF_MEAN|0.06||0.97|TWO_SIDED|||||P-value is adjusted for multiple comparisons; this value is for the 6-month follow-up.|Regression, Linear|Models control for clinic, gender, AUDIT score and are adjusted for multiple time points.||||||0.97
72467031|NCT05178979|144457455|SUPERIORITY||unstandardized beta|-0.29|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|||||P-value is adjusted for multiple comparisons; this value is for the 12-month follow-up.|Regression, Linear|Models control for clinic, gender, AUDIT score and are adjusted for multiple time points.||||||<0.001
72467032|NCT05178979|144457456|SUPERIORITY||Wald Chi-square|9.46||||0.01|TWO_SIDED|||||Models control for clinic, gender, years living with HIV, AUDIT score and are adjusted for multiple time points. Models run using generalized estimating equations (GEE) to account for dependence in repeated, clustered data.|Regression, Linear||Wald Chi-Square tests the overall arm\*time intervention effect across the timepoints|||||0.01
72467033|NCT05178979|144457456|SUPERIORITY||unstandardized beta|0.03|STANDARD_ERROR_OF_MEAN|0.12||0.81|TWO_SIDED|||||P-value is adjusted for multiple comparisons; this value is for the 6-month follow-up.|Regression, Linear|Models control for clinic, gender, years living with HIV, AUDIT score and are adjusted for multiple time points.||||||0.81
72467034|NCT05178979|144457456|SUPERIORITY||unstandardized beta|-0.25|STANDARD_ERROR_OF_MEAN|0.13||0.04|TWO_SIDED|||||P-value is adjusted for multiple comparisons; this value is for the 12-month follow-up.|Regression, Linear|Models control for clinic, gender, years living with HIV, AUDIT score and are adjusted for multiple time points.||||||0.04
72467035|NCT05178979|144457457|SUPERIORITY||Wald Chi-square|14.77|||<|0.001|TWO_SIDED|||||Models control for clinic, gender, years living with HIV and are adjusted for multiple time points. Models run using generalized estimating equations (GEE) to account for dependence in repeated, clustered data.|Regression, Linear||Wald Chi-Square tests the overall arm\*time intervention effect across the timepoints|||||<0.001
72467036|NCT05178979|144457457|SUPERIORITY||unstandardized beta|0.12|STANDARD_ERROR_OF_MEAN|0.16||0.45|TWO_SIDED|||||P-value is adjusted for multiple comparisons; this value is for the 6-month follow-up.|Regression, Linear|Models control for clinic, gender, years living with HIV and are adjusted for multiple time points.||||||0.45
72467037|NCT05178979|144457457|SUPERIORITY||unstandardized beta|-0.43|STANDARD_ERROR_OF_MEAN|0.18||0.02|TWO_SIDED|||||P-value is adjusted for multiple comparisons; this value is for the 12-month follow-up.|Regression, Linear|Models control for clinic, gender, years living with HIV and are adjusted for multiple time points.||||||0.02
72467038|NCT05178979|144457458|SUPERIORITY||Wald Chi-square|11.06||||0.004|TWO_SIDED|||||Models control for clinic, AUDIT score, food insecurity and are adjusted for multiple time points. Models run using generalized estimating equations (GEE) to account for dependence in repeated, clustered data.|Regression, Linear||Wald Chi-Square tests the overall arm\*time intervention effect across the timepoints|||||0.004
72467039|NCT05178979|144457458|SUPERIORITY||unstandardized beta|-0.06|STANDARD_ERROR_OF_MEAN|0.06||0.35|TWO_SIDED|||||P-value is adjusted for multiple comparisons; this value is for the 6-month follow-up.|Regression, Linear|Models control for clinic, AUDIT score, food insecurity and are adjusted for multiple time points.||||||0.35
72621770|NCT01197300|144773944|OTHER|Difference in least squares mean = LS mean for the Core treatment Zoledronic acid group - LS mean for the Core treatment Placebo group.|Difference in LS mean|-147.68||||0.4143|TWO_SIDED|95.0|-394.41|99.049||An analysis of covariance (ANCOVA) model was performed on the transformed data with Core treatment, pooled centers, underlying condition treated with glucocorticoids and loge as explanatory variables and pooled centers as random effect.|ANCOVA|The transformed data was calculated by dividing the post-baseline value by the baseline value and then applying the loge transformation||Serum P1NP Change at Month 18||99.049|-394.410|0.4143
72621771|NCT01197300|144773944|OTHER|Difference in least squares mean = LS mean for the Core treatment Zoledronic acid group - LS mean for the Core treatment Placebo group.|Difference in LS mean|-132.437||||0.1266|TWO_SIDED|95.0|-286.452|21.579||An analysis of covariance (ANCOVA) model was performed on the transformed data with Core treatment, pooled centers, underlying condition treated with glucocorticoids and loge as explanatory variables and pooled centers as random effect.|ANCOVA|The transformed data was calculated by dividing the post-baseline value by the baseline value and then applying the loge transformation||Serum P1NP Change at Month 24||21.579|-286.452|0.1266
72621772|NCT01197300|144773945|OTHER|Difference in least squares mean = LS mean for the Core treatment Zoledronic acid group - LS mean for the Core treatment Placebo group.|Difference in LS mean|-17.691||||0.2123|TWO_SIDED|95.0|-41.925|6.543||An analysis of covariance (ANCOVA) model was performed on the transformed data with Core treatment, pooled centers, underlying condition treated with glucocorticoids and loge as explanatory variables and pooled centers as random effect.|ANCOVA|The transformed data was calculated by dividing the post-baseline value by the baseline value and then applying the loge transformation||BSAP Change at Month 18||6.543|-41.925|0.2123
72621773|NCT01197300|144773945|OTHER|Difference in least squares mean = LS mean for the Core treatment Zoledronic acid group - LS mean for the Core treatment Placebo group.|Difference in LS mean|-3.662||||0.4852|TWO_SIDED|95.0|-21.479|14.155||An analysis of covariance (ANCOVA) model was performed on the transformed data with Core treatment, pooled centers, underlying condition treated with glucocorticoids and loge as explanatory variables and pooled centers as random effect.|ANCOVA|The transformed data was calculated by dividing the post-baseline value by the baseline value and then applying the loge transformation||BSAP Change at Month 24||14.155|-21.479|0.4852
72621774|NCT01197300|144773946|OTHER|Difference in least squares mean = LS mean for the Core treatment Zoledronic acid group - LS mean for the Core treatment Placebo group.|Difference in LS mean|-4.661||||0.9009|TWO_SIDED|95.0|-16.647|7.325||An analysis of covariance (ANCOVA) model was performed on the transformed data with Core treatment, pooled centers, underlying condition treated with glucocorticoids and loge as explanatory variables and pooled centers as random effect.|ANCOVA|The transformed data was calculated by dividing the post-baseline value by the baseline value and then applying the loge transformation||Serum NTX Change at Month 18||7.325|-16.647|0.9009
72621775|NCT01197300|144773946|OTHER|Difference in least squares mean = LS mean for the Core treatment Zoledronic acid group - LS mean for the Core treatment Placebo group.|Difference in LS mean|-2.558||||0.9472|TWO_SIDED|95.0|-8.864|3.747||An analysis of covariance (ANCOVA) model was performed on the transformed data with Core treatment, pooled centers, underlying condition treated with glucocorticoids and loge as explanatory variables and pooled centers as random effect.|ANCOVA|The transformed data was calculated by dividing the post-baseline value by the baseline value and then applying the loge transformation||Serum NTX Change at Month 24||3.747|-8.864|0.9472
72621776|NCT01197300|144773947|OTHER|Difference in least squares mean = LS mean for the Core treatment Zoledronic acid group - LS mean for the Core treatment Placebo group.|Difference in LS mean|-1.482||||0.46|TWO_SIDED|95.0|-3.805|0.841||An analysis of covariance (ANCOVA) model was performed on the transformed data with Core treatment, pooled centers, underlying condition treated with glucocorticoids and loge as explanatory variables and pooled centers as random effect.|ANCOVA|The transformed data was calculated by dividing the post-baseline value by the baseline value and then applying the loge transformation||Serum TRAP-5b Change at Month 18||0.841|-3.805|0.4600
72467040|NCT05178979|144457458|SUPERIORITY||unstandardized beta|-0.13|STANDARD_ERROR_OF_MEAN|0.06||0.04|TWO_SIDED|||||P-value is adjusted for multiple comparisons; this value is for the 12-month follow-up.|Regression, Linear|Models control for clinic, AUDIT score, food insecurity and are adjusted for multiple time points.||||||0.04
72503644|NCT01287117|144538384|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.39||||0.0879|TWO_SIDED|95.0|0.95|2.03||A pre-specified hierarchical order of testing was employed to adjust for the comparison of multiple omalizumab groups to the placebo group in order to maintain an overall type I error rate of 0.05 (2-sided) within each dose.|Cox proportional hazards model|Covariates included in the analysis were baseline weekly itch severity score (\< 13 vs ≥ 13) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis was that there was no difference between the placebo and the omalizumab 75 mg groups.||2.03|0.95|0.0879
72621777|NCT01197300|144773947|OTHER|Difference in least squares mean = LS mean for the Core treatment Zoledronic acid group - LS mean for the Core treatment Placebo group.|Difference in LS mean|-0.41||||0.9236|TWO_SIDED|95.0|-2.423|1.603||An analysis of covariance (ANCOVA) model was performed on the transformed data with Core treatment, pooled centers, underlying condition treated with glucocorticoids and loge as explanatory variables and pooled centers as random effect.|ANCOVA|The transformed data was calculated by dividing the post-baseline value by the baseline value and then applying the loge transformation||Serum TRAP-5b Change at Month 24||1.603|-2.423|0.9236
72467041|NCT05178979|144457459|SUPERIORITY||Wald Chi-square|2.84||||0.24|TWO_SIDED|||||Models control for clinic, gender, years living with HIV, travel time to clinic and are adjusted for multiple time points. Models run using generalized estimating equations (GEE) to account for dependence in repeated, clustered data.|Regression, Linear||Wald Chi-Square tests the overall arm\*time intervention effect across the timepoints|||||0.24
72467042|NCT05178979|144457459|SUPERIORITY||unstandardized beta|0.02|STANDARD_ERROR_OF_MEAN|0.17||0.92|TWO_SIDED|||||P-value is adjusted for multiple comparisons; this value is for the 6-month follow-up.|Regression, Linear|Models control for clinic, gender, years living with HIV, travel time to clinic and are adjusted for multiple time points.||||||0.92
72621778|NCT01197300|144773948|OTHER|The number and percentage of patients with new vertebral fractures during the 12 month Extension period was presented by Core treatment group. Between-treatment differences were evaluated using Fisher's exact test.||||||1|||||||Fisher Exact|||New vertebral fractures at Month 12 Extension||||1.0000
72467043|NCT05178979|144457459|SUPERIORITY||unstandardized beta|-0.21|STANDARD_ERROR_OF_MEAN|0.16||0.21|TWO_SIDED|||||P-value is adjusted for multiple comparisons; this value is for the 12-month follow-up.|Regression, Linear|Models control for clinic, gender, years living with HIV, travel time to clinic and are adjusted for multiple time points.||||||0.21
72467044|NCT03124550|144457460|OTHER|||||||0.0008|||||||Multilevel Modeling|||Multilevel modeling with the LMER package in R was used to determine whether participants changed in weekly average steps over the 6-week intervention.||||.0008
72467045|NCT03124550|144457461|SUPERIORITY|||||||0.01|||||||t-test, 2 sided|||Pre-test and post-test comparison||||.01
72467046|NCT03124550|144457462|SUPERIORITY|||||||0.94|||||||t-test, 2 sided|||Pre-test and post-test comparison||||.94
72467047|NCT03124550|144457463|OTHER|||||||0.0007|||||||Multilevel Modeling|||Multilevel modeling with the LMER package in R was used to determine whether participants changed in weekly number of social contact over the 6-week intervention.||||.0007
72467048|NCT00909532|144457494|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.6|STANDARD_ERROR_OF_MEAN|1.0|<|0.0001|TWO_SIDED|95.0|8.6|12.6||The primary and key secondary endpoints were analyzed using Hochberg's step-up procedure: test 1, primary (α=0.05); test 2, CFQ-R resp domain (Wk24) and sweat chloride (Wk24)(α=0.05).|Mixed Models Analysis|Denominator degrees of freedom were estimated using the Kenward-Roger approximation.||The primary analysis for the primary efficacy variable was based on a Mixed-Effects Model for Repeated Measures (MMRM). The model included absolute change from baseline in percent predicted forced expiratory volume in 1 second (FEV1) as the dependent variable, treatment (ivacaftor versus placebo) and visit (Day 15, Week 8, Week 16, and Week 24) as fixed effects, and subject as a random effect, with adjustment for the continuous baseline values of age and percent predicted FEV1.||12.6|8.6|<0.0001
72467049|NCT00909532|144457495|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.5|STANDARD_ERROR_OF_MEAN|1.0|<|0.0001|TWO_SIDED|95.0|8.5|12.5||There was no adjustment for multiple comparisons.|Mixed Models Analysis|Denominator degrees of freedom were estimated using the Kenward-Roger approximation. No imputation of missing data was done.||Analysis of this variable was similar to that of the primary analysis of the primary efficacy endpoint. Estimates were obtained from Mixed-Effects Model for Repeated Measures (MMRM) with dependent variable absolute change from baseline, fixed effects for categorical visit and treatment group, and adjustment for the continuous baseline values of age and percent predicted forced expiratory volume in 1 second (FEV1),using unstructured covariance matrix.||12.5|8.5|<0.0001
72467050|NCT00909532|144457496|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.1|STANDARD_ERROR_OF_MEAN|1.7|<|0.0001|TWO_SIDED|95.0|4.7|11.4||Analyzed in sequence: test 1, primary (α=0.05); test 2, using Hochberg's step-up procedure on CFQ-R resp domain(Wk 24) and sweat chloride (Wk 24) (α=0.05).|Mixed Models Analysis|||Through Week 24: Analysis for the respiratory domain score endpoint was similar to that of the primary analysis of the primary efficacy endpoint. Estimates were from Mixed-Effects Model for Repeated Measures (MMRM) with dependent variable absolute change from baseline, fixed effects for categorical visit and treatment group, and adjustment for continuous baseline value for age, domain score, and percent predicted FEV1, using unstructured covariance matrix.||11.4|4.7|<0.0001
72467051|NCT00909532|144457496|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.6|STANDARD_ERROR_OF_MEAN|1.7|<|0.0001|TWO_SIDED|95.0|5.3|11.9||There was no adjustment for multiple comparisons.|Mixed Models Analysis|||Through Week 48: Analysis for the CFQ-R respiratory domain score endpoint was similar to that of the primary analysis of the primary efficacy endpoint. Estimates were from MMRM with dependent variable absolute change from baseline, fixed effects for categorical visit and treatment group, and adjustment for continuous baseline value for age,sweat chloride, and percent predicted FEV1,using unstructured covariance matrix.||11.9|5.3|<0.0001
72467052|NCT00909532|144457497|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-47.9|STANDARD_ERROR_OF_MEAN|1.7|<|0.0001|TWO_SIDED|95.0|-51.3|-44.5||Analyzed in sequence: test 1, primary (α=0.05); test 2, using Hochberg's step-up procedure on CFQ-R resp domain(Wk 24) and sweat chloride (Wk 24) (α=0.05); test 3 using Hochberg's on time to pulmonary exacerbation (Wk 48) and weight (Wk 48).|Mixed Models Analysis|||Through Week 24: Analysis for this variable was similar to that of the primary analysis of the primary efficacy endpoint. Estimates were from Mixed-Effects Model for Repeated Measures (MMRM) with dependent variable absolute change from baseline, fixed effects for categorical visit and treatment group, and adjustment for continuous baseline value for age, sweat chloride, and percent predicted FEV1, using unstructured covariance matrix.||-44.5|-51.3|<0.0001
72467053|NCT00909532|144457497|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-48.1|STANDARD_ERROR_OF_MEAN|1.7|<|0.0001|TWO_SIDED|95.0|-51.5|-44.7||There was no adjustment for multiple comparisons.|Mixed Models Analysis|||Through Week 48: Analysis for this variable was similar to that of the primary analysis of the primary efficacy endpoint. Estimates were from Mixed-Effects Model for Repeated Measures (MMRM) with dependent variable absolute change from baseline, fixed effects for categorical visit and treatment group, and adjustment for continuous baseline value for age, sweat chloride, and percent predicted FEV1, using unstructured covariance matrix.||-44.7|-51.5|<0.0001
72467054|NCT00909532|144457498|SUPERIORITY_OR_OTHER||Cox Proportional Hazard at Week 24|0.4||||0.0016|TWO_SIDED|95.0|0.23|0.71||There was no adjustment for multiple comparisons.|Regression, Cox|||Time to first pulmonary exacerbation through Week 24 was analyzed using Cox regression. The model included a covariate for treatment and adjustments for the age group and percent predicted forced expiratory volume in 1 second (FEV1) severity at baseline.||0.71|0.23|0.0016
72621779|NCT01197300|144773949|OTHER|The number and percentage of patients with new morphometric vertebral fractures during the 12 month extension period was presented by core treatment group. Between-treatment differences will be evaluated using Fisher's exact test.||||||1|||||||Fisher Exact|||New morphometric vertebral fractures at Month 12 Extension||||1.0000
72621780|NCT01197300|144773950|OTHER||Odds Ratio (OR)|4.73||||0.3971|TWO_SIDED|95.0|0.13|173.07||Presented by treatment group and evaluated using a logistic regression model with Core treatment, pooled centers, underlying condition treated with glucocorticoids and Core baseline pain score as explanatory variables.|Regression, Logistic|||Reduction in Pain at Month 15||173.07|0.13|0.3971
72467055|NCT00909532|144457498|SUPERIORITY_OR_OTHER||Cox Proportional Hazard at 48 Weeks|0.46||||0.0012|TWO_SIDED|95.0|0.28|0.73||Analyzed in sequence: test 1, primary (α=0.05); test 2, using Hochberg's step-up procedure on CFQ-R resp domain(Wk 24) and sweat chloride (Wk 24) (α=0.05); test 3 using Hochberg's on time to pulmonary exacerbation (Wk 48) and weight (Wk 48).|Regression, Cox|||Time to first pulmonary exacerbation through Week 48 was analyzed using Cox regression. The model included a covariate for treatment and adjustments for the age group and percent predicted forced expiratory volume in 1 second (FEV1) severity at baseline.||0.73|0.28|0.0012
72467056|NCT00909532|144457499|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.8|STANDARD_ERROR_OF_MEAN|0.5|<|0.0001|TWO_SIDED|95.0|1.8|3.7|||Mixed Models Analysis|There was no adjustment for multiple comparisons.||At Week 24: Analysis for this variable was based on a linear mixed effects (LME) model with treatment as a fixed effect, and intercept, visit (days on study) and treatment by visit interaction as random effects, with adjustment for age group and baseline percent predicted forced expiratory volume in 1 second (FEV1) severity.||3.7|1.8|<0.0001
72467057|NCT00909532|144457499|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.7|STANDARD_ERROR_OF_MEAN|0.7||0.0001|TWO_SIDED|95.0|1.3|4.1||Analyzed in sequence: test 1, primary (α=0.05); test 2, using Hochberg's step-up procedure on CFQ-R resp domain(Wk 24) and sweat chloride (Wk 24) (α=0.05).|Mixed Models Analysis|||At Week 48: Analysis for this variable was based on a linear mixed effects (LME) model with treatment as a fixed effect and visit (days on study) and treatment by visit interaction as random effects, with adjustment for age group and baseline percent predicted forced expiratory volume in 1 second (FEV1) severity.||4.1|1.3|0.0001
72467058|NCT01536197|144457500|SUPERIORITY_OR_OTHER|||||||0.19|||||||ANOVA|Two-way ANOVAs with group (gastric bypass and lap banding) as the between-subjects factor and time (before after surgery).||||||0.19
72467059|NCT01024036|144457633|SUPERIORITY_OR_OTHER||difference in the response rate|34.0||||0.0012|TWO_SIDED|95.0|11.1|54.8|||Cochran-Mantel-Haenszel|Adjusted for the stratification factor: corticosteroid use||Null hypothesis: there is no difference in the durable tumor and symptomatic response rate between the 2 treatment arms||54.8|11.1|0.0012
72467060|NCT01024036|144457633|SUPERIORITY_OR_OTHER||difference in the response rate|34.0||||0.0004|TWO_SIDED|95.0|11.1|54.8|||Fisher Exact|Without adjusting for the stratification factor: corticosteroid use||Null hypothesis: there is no difference in the durable tumor and symptomatic response rate between the 2 treatment arms||54.8|11.1|0.0004
72467061|NCT01024036|144457635|SUPERIORITY_OR_OTHER||Difference in overall response rates|33.9||||0.0022|TWO_SIDED|95.0|11.1|54.8|||Cochran-Mantel-Haenszel|||||54.8|11.1|0.0022
72467062|NCT01024036|144457637|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.418||||0.0084|TWO_SIDED|95.0|0.214|0.815|||Log Rank||Hazard ratio and 95% CI from a Cox proportional hazards model|||0.815|0.214|0.0084
72467063|NCT01024036|144457638|SUPERIORITY_OR_OTHER||Difference of hemoglobin response rates|61.3||||0.0002|TWO_SIDED|95.0|28.3|85.1|||Cochran-Mantel-Haenszel||Difference in hemoglobin response rates is equal to hemoglobin response rate for siltuximab+best supportive care \[BSC\] arm minus hemoglobin response rate for Placebo+BSC arm.|||85.1|28.3|0.0002
72467064|NCT01024036|144457639|SUPERIORITY_OR_OTHER||Difference of hemoglobin response rates|41.9||||0.0195|TWO_SIDED|95.0|7.8|70.7|||Cochran-Mantel-Haenszel||Difference in hemoglobin response rates is equal to hemoglobin response rate for siltuximab+best supportive care \[BSC\] arm minus hemoglobin response rate for Placebo+BSC arm.|||70.7|7.8|0.0195
72467065|NCT03459612|144457645|NON_INFERIORITY|Non-inferiority p-value tests null hypothesis that difference in LS means ≥ 4.4 versus alternative hypothesis that difference in Least Square (LS) means \< 4.4.|Difference in LS Means|0.98|||<|0.0001|TWO_SIDED|95.0|-0.43|2.39|||Mixed Models Analysis|||||2.39|-0.43|<0.0001
72467066|NCT03459612|144457645|NON_INFERIORITY|Non-inferiority p-value tests null hypothesis that difference in LS means ≥ 4.4 versus alternative hypothesis that difference in LS means \< 4.4.|LS Means|1.76|||<|0.0001|TWO_SIDED|95.0|0.32|3.2|||Mixed Models Analysis|||||3.20|0.32|<0.0001
72467067|NCT03459612|144457645|NON_INFERIORITY|Non-inferiority p-value tests null hypothesis that difference in LS means ≥ 4.4 versus alternative hypothesis that difference in LS means \< 4.4.|LS Means|4.98|||<|0.0001|TWO_SIDED|95.0|3.58|6.38|||Mixed Models Analysis|||||6.38|3.58|<0.0001
72467068|NCT03459612|144457646|NON_INFERIORITY|Non-inferiority p-value tests null hypothesis that difference in LS means ≥ 4.4 versus alternative hypothesis that difference in LS means \< 4.4.|Difference in LS Means|-0.12|||<|0.0001|TWO_SIDED|95.0|-1.28|1.04|||Mixed Models Analysis|||||1.04|-1.28|<0.0001
72467069|NCT03459612|144457646|NON_INFERIORITY|Non-inferiority p-value tests null hypothesis that difference in LS means ≥ 4.4 versus alternative hypothesis that difference in LS means \< 4.4.|Difference in LS Means|-0.32|||<|0.0001|TWO_SIDED|95.0|-1.51|0.88|||Mixed Models Analysis|||||0.88|-1.51|<0.0001
72467070|NCT03459612|144457646|NON_INFERIORITY|Non-inferiority p-value tests null hypothesis that difference in LS means ≥ 4.4 versus alternative hypothesis that difference in LS means \< 4.4.|Difference in LS Means|4.31|||<|0.0001|TWO_SIDED|95.0|3.17|5.45|||Mixed Models Analysis|||||5.45|3.17|<0.0001
72621781|NCT01197300|144773950|OTHER||Odds Ratio (OR)|0.01||||0.6046|TWO_SIDED|95.0|0.01|999.99||Presented by treatment group and evaluated using a logistic regression model with Core treatment, pooled centers, underlying condition treated with glucocorticoids and Core baseline pain score as explanatory variables.|Regression, Logistic|||Reduction in Pain at Month 18||999.99|0.01|0.6046
72467071|NCT03459612|144457647|NON_INFERIORITY|Non-inferiority p-value tests null hypothesis that difference in LS means ≥ 4.4 versus alternative hypothesis that difference in LS means \< 4.4.|Differnce in LS Means|-0.97|||<|0.0001|TWO_SIDED|95.0|-2.3|0.36|||Mixed Models Analysis|||||0.36|-2.30|<0.0001
72467072|NCT03459612|144457647|NON_INFERIORITY|Non-inferiority p-value tests null hypothesis that difference in LS means ≥ 4.4 versus alternative hypothesis that difference in LS means \< 4.4.|Difference in LS Means|-1.04|||<|0.0001|TWO_SIDED|95.0|-2.4|0.32|||Mixed Models Analysis|||||0.32|-2.40|<0.0001
72467073|NCT03459612|144457647|NON_INFERIORITY|Non-inferiority p-value tests null hypothesis that difference in LS means ≥ 4.4 versus alternative hypothesis that difference in LS means \< 4.4.|Difference in LS Means|4.05|||<|0.0001|TWO_SIDED|95.0|2.73|5.38|||Mixed Models Analysis|||||5.38|2.73|<0.0001
72467074|NCT03459612|144457648|SUPERIORITY||Differences of Least Square Mean|0.28|||||TWO_SIDED|95.0|-0.15|0.7||||||||0.70|-0.15|
72467075|NCT03459612|144457648|SUPERIORITY||Difference of Least Square Means|0.66|||||TWO_SIDED|95.0|0.22|1.1||||||||1.10|0.22|
72467076|NCT03459612|144457648|SUPERIORITY||Difference of Least Square Means|0.81|||||TWO_SIDED|95.0|0.39|1.24||||||||1.24|0.39|
72467077|NCT03459612|144457649|SUPERIORITY||Difference of Least Square Means|0.48|||||TWO_SIDED|95.0|0.0|0.96||||||||0.96|0.00|
72467078|NCT03459612|144457649|SUPERIORITY||Differnce of Least Square Means|0.34|||||TWO_SIDED|95.0|-0.14|0.82||||||||0.82|-0.14|
72564717|NCT04019054|144660979|OTHER|This was a goodness of fit test of a multi-level model, fit was tested using a wald chi-square test.|||||<|0.001||||||a priori threshold for significance of p=0.05|Chi-squared|This was specifically a wald chi-square test, performed in Stata for the purpose of assessing goodness-of-fit of a mixed effects model||Goodness of fit test of a two-variable negative binomial multi-level model of anticipatory distress as a function of treatment group and timepoint. This multi-level model was generated using the menbreg function in Stata 16||||<.001
72564718|NCT04019054|144660979|SUPERIORITY||||||<|0.001||||||a priori threshold for significance of 0.05|Mixed Models Analysis|||This statistical analysis involved testing of the step-by-timepoint interaction in the two-variable negative binomial model of anticipatory distress as a function of group and timepoint.||||<0.001
72564719|NCT04019054|144660979|OTHER|This was a goodness of fit test of a multi-level model, fit was tested using a wald chi-square test.|||||<|0.001||||||a priori threshold for significance was p=0.05.|Chi-squared|This was specifically a wald chi-square test, performed in Stata for the purpose of assessing goodness-of-fit of a mixed effects model||Goodness of fit test of a two-variable negative binomial multi-level model of anticipatory distress as a function of step and group. This multi-level model was generated using the menbreg function in Stata 16||||<0.001
72564720|NCT04019054|144660979|SUPERIORITY|||||||0.047||||||a priori threshold for significance of 0.05|Mixed Models Analysis|||This statistical analysis involved testing of the step-by-timepoint interaction in the two-variable negative binomial model of anticipatory distress as a function of step and group.||||0.047
72564721|NCT04019054|144660980|SUPERIORITY||Mann Whitney U statistic|13.5|STANDARD_ERROR_OF_MEAN|9.58||0.027|TWO_SIDED|||||a priori threshold for significance of p=0.05|Wilcoxon (Mann-Whitney)|||2-sided Mann-Whitney U Test (nonparametric) utilized to compare the ability of the groups to tolerate treatment intensity.||||0.027
72564722|NCT04019054|144660982|OTHER|A pair of chi-square analyses were performed to validate blinding of the study (based on questionnaires completed by subjects and raters). Given the small sample size, Fisher's exact method was utilized. The number of correct and incorrect guesses for each group were examined once for the subject guesses and once for the rater's guesses.|||||>|0.05|||||||Fisher Exact|For the subjects, p=0.64 using Fisher's exact method. For the raters, p=1 using Fisher's exact method.||||||>.05
72621782|NCT01197300|144773950|OTHER||Odds Ratio (OR)|0.01||||0.6046|TWO_SIDED|95.0|0.01|999.99||Presented by treatment group and evaluated using a logistic regression model with Core treatment, pooled centers, underlying condition treated with glucocorticoids and Core baseline pain score as explanatory variables.|Regression, Logistic|||Reduction in Pain at Month 21||999.99|0.01|0.6046
72621783|NCT01197300|144773950|OTHER||Odds Ratio (OR)|1.31||||0.875|TWO_SIDED|95.0|0.05|38.04||Presented by treatment group and evaluated using a logistic regression model with Core treatment, pooled centers, underlying condition treated with glucocorticoids and Core baseline pain score as explanatory variables.|Regression, Logistic|||Reduction in Pain at Month 24||38.04|0.05|0.8750
72621784|NCT01197300|144773951|OTHER|Difference in least squares mean = LS mean for the Core treatment Zoledronic acid group - LS mean for the Core treatment Placebo group.|Difference in LS mean|-0.01||||0.9231|TWO_SIDED|95.0|-0.18|0.17||An analysis of covariance (ANCOVA) model was performed with Core treatment, pooled centers, underlying condition treated with GCs and Core baseline bone age as explanatory variables and pooled centers as random effect.|ANCOVA|||2nd metacarpal cortical width chge from BL1 at Month 24||0.17|-0.18|0.9231
72621785|NCT01197300|144773951|OTHER|Difference in least squares mean = LS mean for the Core treatment Zoledronic acid group - LS mean for the Core treatment Placebo group.|Difference in LS mean|-0.11||||0.2694|TWO_SIDED|95.0|-0.32|0.1||An analysis of covariance (ANCOVA) model was performed with Core treatment, pooled centers, underlying condition treated with GCs and Extension baseline bone age as explanatory variables and pooled centers as random effect.|ANCOVA|||2nd metacarpal cortical width chge from BL2 at Month 24||0.10|-0.32|0.2694
72503645|NCT01287117|144538384|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.49||||0.0301|TWO_SIDED|95.0|1.04|2.14||A pre-specified hierarchical order of testing was employed to adjust for the comparison of multiple omalizumab groups to the placebo group in order to maintain an overall type I error rate of 0.05 (2-sided) within each dose.|Cox proportional hazards model|Covariates included in the analysis were baseline weekly itch severity score (\< 13 vs ≥ 13) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis was that there was no difference between the placebo and the omalizumab 150 mg groups.||2.14|1.04|0.0301
72503646|NCT01287117|144538384|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.34|||<|0.0001|TWO_SIDED|95.0|1.63|3.36||A pre-specified hierarchical order of testing was employed to adjust for the comparison of multiple omalizumab groups to the placebo group in order to maintain an overall type I error rate of 0.05 (2-sided) within each dose.|Cox proportional hazards model|Covariates included in the analysis were baseline weekly itch severity score (\< 13 vs ≥ 13) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis was that there was no difference between the placebo and the omalizumab 300 mg groups.||3.36|1.63|<0.0001
72467079|NCT03459612|144457649|SUPERIORITY||Difference of Least Square Means|1.29|||||TWO_SIDED|95.0|0.81|1.78||||||||1.78|0.81|
72467080|NCT03459612|144457650|SUPERIORITY||Difference of Least Square Means|-0.58|||||TWO_SIDED|95.0|-1.1|-0.06||||||||-0.06|-1.10|
72467081|NCT03459612|144457650|SUPERIORITY||Difference of Least Square Means|-0.4|||||TWO_SIDED|95.0|-0.89|0.09||||||||0.09|-0.89|
72467082|NCT03459612|144457650|SUPERIORITY||Difference of Least Square Means|0.44|||||TWO_SIDED|95.0|-0.09|0.96||||||||0.96|-0.09|
72467083|NCT03459612|144457651|SUPERIORITY||Difference in Least Square Means|0.0|||||TWO_SIDED|95.0|-1.61|1.62||||||||1.62|-1.61|
72467084|NCT03459612|144457651|SUPERIORITY||Difference in Lease Square Means|-0.74|||||TWO_SIDED|95.0|-2.49|1.01||||||||1.01|-2.49|
72467085|NCT03459612|144457651|SUPERIORITY||Difference in Least Square Means|-0.72|||||TWO_SIDED|95.0|-2.32|0.89||||||||0.89|-2.32|
72467086|NCT03459612|144457652|SUPERIORITY||Difference of Least Square Means|-1.79|||||TWO_SIDED|95.0|-3.52|-0.06||||||||-0.06|-3.52|
72503647|NCT01287117|144538385|SUPERIORITY_OR_OTHER|||||||0.0148||95.0||||A pre-specified hierarchical order of testing was employed to adjust for the comparison of multiple omalizumab groups to the placebo group in order to maintain an overall type I error rate of 0.05 (2-sided) within each dose.|Cochran-Mantel-Haenszel|Covariates included in the analysis were baseline UAS7 (\< median vs ≥ median) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis was that there was no difference between the placebo and the omalizumab 75 mg groups. The p-value was not evaluated for statistical significance in accordance with the type I error rate control plan.||||0.0148
72564723|NCT04019054|144660983|OTHER|This was a goodness of fit test of a multi-level model, fit was tested using a wald chi-square test.|||||<|0.001||||||a priori threshold for significance was p=0.05.|Chi-squared|This was specifically a wald chi-square test, performed in Stata for the purpose of assessing goodness-of-fit of a mixed effects model||Goodness of fit test of a two-variable negative binomial multi-level model of maximum distress as a function of step and timepoint. This multi-level model was generated using the menbreg function in Stata 16||||<.001
72564724|NCT04019054|144660983|SUPERIORITY||||||>|0.05||||||a priori threshold for significance of 0.05|Mixed Models Analysis|||This statistical analysis involved testing of the step-by-timepoint interaction in the two-variable negative binomial model of maximum distress as a function of step and timepoint.||||>.05
72467087|NCT03459612|144457652|SUPERIORITY||Difference in Least Square Means|-0.29|||||TWO_SIDED|95.0|-2.0|1.42||||||||1.42|-2.00|
72467088|NCT03459612|144457652|SUPERIORITY||Difference in Least Square Means|-3.81|||||TWO_SIDED|95.0|-5.53|-2.08||||||||-2.08|-5.53|
72467089|NCT03459612|144457653|SUPERIORITY||Difference of Least Square Means|-0.28|||||TWO_SIDED|95.0|-1.71|1.15||||||||1.15|-1.71|
72467090|NCT03459612|144457653|SUPERIORITY||Difference of Least Square Means|-0.31|||||TWO_SIDED|95.0|-1.71|1.08||||||||1.08|-1.71|
72467091|NCT03459612|144457653|SUPERIORITY||Difference of Least Square Means|-2.7|||||TWO_SIDED|95.0|-4.13|-1.27||||||||-1.27|-4.13|
72467092|NCT03459612|144457654|SUPERIORITY||Mean Difference (Final Values)|-0.03|STANDARD_DEVIATION|0.3||0.6875|TWO_SIDED||||||Wilcoxon Signed Rank test|||||||0.6875
72467093|NCT03459612|144457654|SUPERIORITY||Mean Difference (Final Values)|-0.04|STANDARD_DEVIATION|0.27||0.375|TWO_SIDED||||||Wilcoxon Signed Rank test|||||||0.3750
72564725|NCT04019054|144660983|OTHER|This was a goodness of fit test of a multi-level model, fit was tested using a wald chi-square test.|||||<|0.001||||||a priori threshold for significance of p=0.05|Chi-squared|This was specifically a wald chi-square test, performed in Stata for the purpose of assessing goodness-of-fit of a mixed effects model||Goodness of fit test of a two-variable negative binomial multi-level model of maximum distress as a function of treatment group and timepoint. This multi-level model was generated using the menbreg function in Stata 16||||<.001
72621786|NCT00581100|144773960|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Mixed Models Analysis|Adjusted change calculated from mixed-model. Model for change = \[Group visit Group\*visit baseline baseline\*visit\].||||||<0.0001
72621787|NCT00581100|144773960|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Adjusted change calculated from mixed-model. Model for change = \[Group visit Group\*visit baseline baseline\*visit\].|Mixed Models Analysis|||||||<0.0001
72467094|NCT03459612|144457654|SUPERIORITY||Mean Difference (Final Values)|0.3|STANDARD_DEVIATION|1.0||0.0115|TWO_SIDED||||||Wilcoxon Signed Rank test|||||||0.0115
72467095|NCT03459612|144457655|SUPERIORITY||Mean Difference (Final Values)|-0.09|STANDARD_DEVIATION|0.42||0.1563|TWO_SIDED||||||Wilcoxon Signed Rank test|||||||0.1563
72467096|NCT03459612|144457655|SUPERIORITY||Mean Difference (Final Values)|-0.04|STANDARD_DEVIATION|0.44||0.5938|TWO_SIDED||||||Wilcoxon Signed Rank test|||||||0.5938
72467097|NCT03459612|144457655|SUPERIORITY||Mean Difference (Final Values)|0.12|STANDARD_DEVIATION|0.54||0.0938|TWO_SIDED||||||Wilcoxon Signed Rank test|||||||0.0938
72467098|NCT03459612|144457656|SUPERIORITY||Mean Difference (Final Values)|-0.12|STANDARD_DEVIATION|0.56||0.125|TWO_SIDED||||||Wilcoxon Signed Rank test|||||||0.1250
72467099|NCT03459612|144457656|SUPERIORITY||Mean Difference (Final Values)|0.03|STANDARD_DEVIATION|0.94||0.959|TWO_SIDED||||||Wilcoxon Signed Rank test|||||||0.9590
72621788|NCT00581100|144773961|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Mixed Models Analysis|Adjusted change calculated from mixed-model. Model for change = \[Group visit Group\*visit baseline baseline\*visit\].||||||<0.0001
72621789|NCT00581100|144773961|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Adjusted change calculated from mixed-model. Model for change = \[Group visit Group\*visit baseline baseline\*visit\].|Mixed Models Analysis|||||||<0.0001
72467100|NCT03459612|144457656|SUPERIORITY||Mean Difference (Final Values)|0.46|STANDARD_DEVIATION|1.76||0.0097|TWO_SIDED||||||Wilcoxon Signed Rank test|||||||0.0097
72467101|NCT01817712|144457667|SUPERIORITY||Odds Ratio (OR)|2.14|||<|0.001|TWO_SIDED|95.0|1.46|3.14|||Regression, Logistic|||||3.14|1.46|<0.001
72467102|NCT01817712|144457668|SUPERIORITY|||||||0.004|||||||Kruskal-Wallis|Site used as strata||||||0.004
72467103|NCT01817712|144457669|OTHER|Longitudinal analysis of PCL-5 (change from baseline)|Mean Difference (Net)|-1.9||||0.07|TWO_SIDED|95.0|-3.91|0.12|||Mixed Models Analysis|||||0.12|-3.91|0.07
72467104|NCT02080403|144457726|SUPERIORITY||Mean Difference (Final Values)|-0.18||||0.1159|TWO_SIDED|95.0|-0.4|0.04|||Mixed Models Analysis|||||0.04|-0.40|0.1159
72467105|NCT02034162|144457825|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||< 0.001
72467106|NCT02034162|144457826|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||< 0.001
72467107|NCT02034162|144457828|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANCOVA|||||||< 0.001
72467108|NCT02034162|144457829|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANCOVA|||||||< 0.001
72467109|NCT03024996|144457842|SUPERIORITY||Hazard Ratio (HR)|0.93||||0.495|TWO_SIDED|95.0|0.75|1.15|||Log Rank|||||1.15|0.75|0.4950
72467110|NCT03024996|144457843|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.8868||95.0|0.67|1.42|||Log Rank|||||1.42|0.67|0.8868
72467111|NCT03024996|144457844|SUPERIORITY||Hazard Ratio (HR)|0.83||||0.201|TWO_SIDED|95.0|0.63|1.1|||Log Rank|||||1.10|0.63|0.2010
72467112|NCT03024996|144457845|SUPERIORITY||Hazard Ratio (HR)|0.87||||0.2811|TWO_SIDED|95.0|0.69|1.12|||Log Rank|||||1.12|0.69|0.2811
72467113|NCT03024996|144457846|SUPERIORITY||Hazard Ratio (HR)|0.75||||0.0735|TWO_SIDED|95.0|0.55|1.03|||Log Rank|||||1.03|0.55|0.0735
72564726|NCT04019054|144660983|SUPERIORITY||||||<|0.001||||||a priori threshold for significance of p=0.05|Mixed Models Analysis|||This statistical analysis involved testing of the step-by-timepoint interaction in the two-variable negative binomial model of maximum distress as a function of group and timepoint.||||<.001
72467114|NCT03024996|144457847|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.1396|TWO_SIDED|95.0|0.67|1.06|||Log Rank|||||1.06|0.67|0.1396
72467115|NCT03024996|144457848|SUPERIORITY||Hazard Ratio (HR)|0.85||||0.4762|TWO_SIDED|95.0|0.55|1.33|||Log Rank|||||1.33|0.55|0.4762
72467116|NCT03024996|144457849|SUPERIORITY||Hazard Ratio (HR)|0.93||||0.5111|TWO_SIDED|95.0|0.74|1.16|||Log Rank|||||1.16|0.74|0.5111
72467117|NCT02106195|144457869|SUPERIORITY|Change from Baseline to Day 28|Mean Difference (Final Values)|-1.1|STANDARD_DEVIATION|3.04||0.324|TWO_SIDED|95.0|-3.7|1.4|||t-test, 2 sided|||||1.4|-3.7|0.324
72467118|NCT04469465|144457875|SUPERIORITY|||||||0.0007|||||||Re-randomization Test|||Interim Efficacy Analysis||||0.0007
72467119|NCT04469465|144457875|SUPERIORITY|||||||0.0007|||||||Re-randomization Test|||Full Analysis||||0.0007
72503648|NCT01287117|144538385|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||A pre-specified hierarchical order of testing was employed to adjust for the comparison of multiple omalizumab groups to the placebo group in order to maintain an overall type I error rate of 0.05 (2-sided) within each dose.|Cochran-Mantel-Haenszel|Covariates included in the analysis were baseline UAS7 (\< median vs ≥ median) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis was that there was no difference between the placebo and the omalizumab 150 mg groups.||||<0.0001
72503649|NCT01287117|144538385|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||A pre-specified hierarchical order of testing was employed to adjust for the comparison of multiple omalizumab groups to the placebo group in order to maintain an overall type I error rate of 0.05 (2-sided) within each dose.|Cochran-Mantel-Haenszel|Covariates included in the analysis were baseline UAS7 (\< median vs ≥ median) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis was that there was no difference between the placebo and the omalizumab 300 mg groups.||||<0.0001
72503650|NCT01287117|144538386|SUPERIORITY_OR_OTHER|||||||0.0118||95.0||||A pre-specified hierarchical order of testing was employed to adjust for the comparison of multiple omalizumab groups to the placebo group in order to maintain an overall type I error rate of 0.05 (2-sided) within each dose.|Cochran-Mantel-Haenszel|Covariates included in the analysis were baseline weekly itch severity score (\< 13 vs ≥ 13) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis was that there was no difference between the placebo and the omalizumab 75 mg groups. The p-value was not evaluated for statistical significance in accordance with the type I error rate control plan.||||0.0118
72503651|NCT01287117|144538386|SUPERIORITY_OR_OTHER|||||||0.0226||95.0||||A pre-specified hierarchical order of testing was employed to adjust for the comparison of multiple omalizumab groups to the placebo group in order to maintain an overall type I error rate of 0.05 (2-sided) within each dose.|Cochran-Mantel-Haenszel|Covariates included in the analysis were baseline weekly itch severity score (\< 13 vs ≥ 13) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis was that there was no difference between the placebo and the omalizumab 150 mg groups.||||0.0226
72503652|NCT01287117|144538386|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||A pre-specified hierarchical order of testing was employed to adjust for the comparison of multiple omalizumab groups to the placebo group in order to maintain an overall type I error rate of 0.05 (2-sided) within each dose.|Cochran-Mantel-Haenszel|Covariates included in the analysis were baseline weekly itch severity score (\< 13 vs ≥ 13) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis was that there was no difference between the placebo and the omalizumab 300 mg groups.||||<0.0001
72504845|NCT03551522|144540604|OTHER|The LS Means, confidence intervals, and p-values come from an ANCOVA model with relative (percent) change from baseline as the dependent variable and treatment and stratification groups (diabetic status and fibrosis stage) as factors and baseline as a covariate.|LS Mean of Difference|6.54||||0.3151|TWO_SIDED|95.0|-6.28|19.37|||ANCOVA|||||19.37|-6.28|0.3151
72467120|NCT04469465|144457875|SUPERIORITY||LS Mean Difference|24.44|STANDARD_ERROR_OF_MEAN|3.751|<|0.0001|TWO_SIDED|95.0|16.9|31.99|||Mixed Models Analysis|||Interim Efficacy Analysis||31.99|16.90|<0.0001
72467121|NCT04469465|144457875|SUPERIORITY||Difference|23.46|STANDARD_ERROR_OF_MEAN|3.585|<|0.0001|TWO_SIDED|95.0|16.31|30.61|||Mixed Models Analysis|||Full Analysis||30.61|16.31|<0.0001
72467122|NCT03568812|144457894|SUPERIORITY||Mean Difference (Net)|111.8||||0.02|TWO_SIDED|95.0|40.9|182.7||The threshold for statistical significance was p = 0.05 The variable was adjusted to duration of ARV regimen and baseline CD4 level|ANCOVA||Treatment difference = Probiotics - Placebo|The statistical analysis of unadjusted CD4 level||182.7|40.9|0.02
72467123|NCT03568812|144457894|SUPERIORITY||Mean Difference (Net)|73.4||||0.03|TWO_SIDED|95.0|5.9|140.8||The threshold for statistical significance was p = 0.05 The variable was adjusted to duration of ARV regimen and baseline CD4 level|ANCOVA||Treatment difference = Probiotics - Placebo|The statistical analysis of adjusted CD4 level||140.8|5.9|0.03
72467124|NCT03568812|144457895|SUPERIORITY||Mean Difference (Net)|0.3||||0.55|TWO_SIDED|95.0|-0.5|1.0||The threshold for statistical significance was p = 0.05 The variable was adjusted to duration of ARV regimen and baseline CD4 level|ANCOVA||There is no difference between probiotics - placebo|The statistical analysis of unadjusted Th17 change after intervention||1.0|-0.5|0.55
72467125|NCT03568812|144457895|SUPERIORITY||Mean Difference (Net)|0.1||||0.79|TWO_SIDED|95.0|-0.7|0.9||The threshold for statistical significance was p = 0.05 The variable was adjusted to duration of ARV regimen and baseline CD4 level|ANCOVA||There is no difference between probiotics - placebo|The statistical analysis of adjusted Th17 change after intervention||0.9|-0.7|0.79
72467126|NCT03568812|144457897|SUPERIORITY||Mean Difference (Net)|-12.7||||0.03|TWO_SIDED|95.0|-23.9|-1.5||The threshold for statistical significance was p = 0.05 The variable was adjusted to duration of ARV regimen and baseline CD4 level|ANCOVA||Treatment difference = Probiotics - Placebo|The statistical analysis of unadjusted Fecal Calprotectin Level change after intervention||-1.5|-23.9|0.03
72467127|NCT03568812|144457897|SUPERIORITY||Mean Difference (Net)|-15.6||||0.01|TWO_SIDED|95.0|-27.6|-3.6||The threshold for statistical significance was p = 0.05 The variable was adjusted to duration of ARV regimen and baseline CD4 level|ANCOVA||Treatment difference = Probiotics - Placebo|The statistical analysis of adjusted Fecal Calprotectin Level change after intervention||-3.6|-27.6|0.01
72467128|NCT03568812|144457899|SUPERIORITY|||||||0.551||||||The threshold for statistical significance was p = 0.05|Chi-squared|||The statistical analysis of food frequency change after intervention (12 weeks)||||0.551
72467129|NCT00464945|144457918|SUPERIORITY_OR_OTHER||Difference|0.7||||||95.0|-3.9|5.6||||||For serotype 4 the difference in percentages between the two groups (13vPnC Manufacturing - 13vPnC Pilot) was calculated||5.6|-3.9|
72394567|NCT02310568|144295791|SUPERIORITY_OR_OTHER||LS Mean Difference|1.0|STANDARD_ERROR_OF_MEAN|1.72||0.575|TWO_SIDED|90.0|-1.9|3.8|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - Placebo). Week 3: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1.||3.8|-1.9|0.575
72394568|NCT02310568|144295791|SUPERIORITY_OR_OTHER||LS Mean Difference|1.5|STANDARD_ERROR_OF_MEAN|1.67||0.362|TWO_SIDED|90.0|-1.2|4.3|||Mixed-Effects Model Repeated Measure|||(PF-06372865 2.5 mg - Placebo). Week 3: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1.||4.3|-1.2|0.362
72467130|NCT00464945|144457918|SUPERIORITY_OR_OTHER||Difference|3.3||||||95.0|-7.3|13.8||||||For serotype 6B the difference in percentages between the two groups (13vPnC Manufacturing - 13vPnC Pilot) was calculated||13.8|-7.3|
72467131|NCT00464945|144457918|SUPERIORITY_OR_OTHER||Difference|2.3||||||95.0|-2.1|7.3||||||For serotype 9V the difference in percentages between the two groups (13vPnC Manufacturing - 13vPnC Pilot) was calculated||7.3|-2.1|
72467132|NCT00464945|144457918|SUPERIORITY_OR_OTHER||Difference|-1.6||||||95.0|-8.2|4.7||||||For serotype 14 the difference in percentages between the two groups (13vPnC Manufacturing - 13vPnC Pilot) was calculated||4.7|-8.2|
72467133|NCT00464945|144457918|SUPERIORITY_OR_OTHER||Difference|3.0||||||95.0|-2.8|9.2||||||For serotype 18C the difference in percentages between the two groups (13vPnC Manufacturing - 13vPnC Pilot) was calculated||9.2|-2.8|
72467134|NCT00464945|144457918|SUPERIORITY_OR_OTHER||Difference|0.7||||||95.0|-3.5|5.1||||||For serotype 19F the difference in percentages between the two groups (13vPnC Manufacturing - 13vPnC Pilot) was calculated||5.1|-3.5|
72467135|NCT00464945|144457918|SUPERIORITY_OR_OTHER||Difference|1.1||||||95.0|-8.4|10.6||||||For serotype 23F the difference in percentages between the two groups (13vPnC Manufacturing - 13vPnC Pilot) was calculated||10.6|-8.4|
72467136|NCT00464945|144457918|SUPERIORITY_OR_OTHER||Difference|2.1||||||95.0|-4.8|9.2||||||For serotype 1 the difference in percentages between the two groups (13vPnC Manufacturing - 13vPnC Pilot) was calculated||9.2|-4.8|
72467137|NCT00464945|144457918|SUPERIORITY_OR_OTHER||Difference|-1.7||||||95.0|-7.9|4.2||||||For serotype 3 the difference in percentages between the two groups (13vPnC Manufacturing - 13vPnC Pilot) was calculated||4.2|-7.9|
72467138|NCT00464945|144457918|SUPERIORITY_OR_OTHER||Difference|2.1||||||95.0|-5.6|9.9||||||For serotype 5 the difference in percentages between the two groups (13vPnC Manufacturing - 13vPnC Pilot) was calculated||9.9|-5.6|
72467139|NCT00464945|144457918|SUPERIORITY_OR_OTHER||Difference|-1.1||||||95.0|-9.9|7.6||||||For serotype 6A the difference in percentages between the two groups (13vPnC Manufacturing - 13vPnC Pilot) was calculated||7.6|-9.9|
72467140|NCT00464945|144457918|SUPERIORITY_OR_OTHER||Difference|0.0||||||95.0|-3.0|2.8||||||For serotype 7F the difference in percentages between the two groups (13vPnC Manufacturing - 13vPnC Pilot) was calculated||2.8|-3.0|
72503653|NCT01287117|144538387|SUPERIORITY_OR_OTHER||Least squares mean difference|-2.34||||0.0124|TWO_SIDED|95.0|-4.17|-0.51||A pre-specified hierarchical order of testing was employed to adjust for the comparison of multiple omalizumab groups to the placebo group in order to maintain an overall type I error rate of 0.05 (2-sided) within each dose.|ANCOVA|Covariates included in the analysis were baseline weekly size of largest hive score (\< median vs ≥ median) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis was that there was no difference between the placebo and the omalizumab 75 mg groups. The p-value was not evaluated for statistical significance in accordance with the type I error rate control plan.||-0.51|-4.17|0.0124
72503654|NCT01287117|144538387|SUPERIORITY_OR_OTHER||Least squares mean difference|-3.16||||0.0012|TWO_SIDED|95.0|-5.05|-1.27||A pre-specified hierarchical order of testing was employed to adjust for the comparison of multiple omalizumab groups to the placebo group in order to maintain an overall type I error rate of 0.05 (2-sided) within each dose.|ANCOVA|Covariates included in the analysis were baseline weekly size of largest hive score (\< median vs ≥ median) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis was that there was no difference between the placebo and the omalizumab 150 mg groups.||-1.27|-5.05|0.0012
72467141|NCT00464945|144457918|SUPERIORITY_OR_OTHER||Difference|0.0||||||95.0|-3.6|3.5||||||For serotype 19A the difference in percentages between the two groups (13vPnC Manufacturing - 13vPnC Pilot) was calculated||3.5|-3.6|
72467142|NCT00464945|144457922|SUPERIORITY_OR_OTHER||Ratio|1.35||||||95.0|1.1|1.65||||||For serotype 4 the GMC ratio was calculated||1.65|1.10|
72467143|NCT00464945|144457922|SUPERIORITY_OR_OTHER||Ratio|0.96||||||95.0|0.7|1.31||||||For serotype 6B the GMC ratio was calculated||1.31|0.70|
72467144|NCT00464945|144457922|SUPERIORITY_OR_OTHER||Ratio|1.05||||||95.0|0.89|1.24||||||For serotype 9V the GMC ratio was calculated||1.24|0.89|
72467145|NCT00464945|144457922|SUPERIORITY_OR_OTHER||Ratio|0.93||||||95.0|0.71|1.22||||||For serotype 14 the GMC ratio was calculated||1.22|0.71|
72467146|NCT00464945|144457922|SUPERIORITY_OR_OTHER||Ratio|1.06||||||95.0|0.86|1.3||||||For serotype 18C the GMC ratio was calculated||1.30|0.86|
72467147|NCT00464945|144457922|SUPERIORITY_OR_OTHER||Ratio|0.98||||||95.0|0.81|1.17||||||For serotype 19F the GMC ratio was calculated||1.17|0.81|
72467148|NCT00464945|144457922|SUPERIORITY_OR_OTHER||Ratio|0.9||||||95.0|0.7|1.15||||||For serotype 23F the GMC ratio was calculated||1.15|0.70|
72467149|NCT00464945|144457922|SUPERIORITY_OR_OTHER||Ratio|1.1||||||95.0|0.88|1.37||||||For serotype 1 the GMC ratio was calculated||1.37|0.88|
72467150|NCT00464945|144457922|SUPERIORITY_OR_OTHER||Ratio|1.0||||||95.0|0.83|1.2||||||For serotype 3 the GMC ratio was calculated||1.20|0.83|
72467151|NCT00464945|144457922|SUPERIORITY_OR_OTHER||Ratio|0.95||||||95.0|0.79|1.16||||||For serotype 5 the GMC ratio was calculated||1.16|0.79|
72467152|NCT00464945|144457922|SUPERIORITY_OR_OTHER||Ratio|0.83||||||95.0|0.66|1.05||||||For serotype 6A the GMC ratio was calculated||1.05|0.66|
72467153|NCT00464945|144457922|SUPERIORITY_OR_OTHER||Ratio|0.93||||||95.0|0.79|1.11||||||For serotype 7F the GMC ratio was calculated||1.11|0.79|
72467154|NCT00464945|144457922|SUPERIORITY_OR_OTHER||Ratio|0.95||||||95.0|0.79|1.13||||||For serotype 19A the GMC ratio was calculated||1.13|0.79|
72467155|NCT03831854|144457923|SUPERIORITY||Median Difference (Final Values)|0.0||||0.08|TWO_SIDED|95.0|0.0|0.0|||Wilcoxon (Mann-Whitney)|||||0|0|0.08
72467156|NCT03831854|144457924|SUPERIORITY|||||||0.11|||||||Fisher Exact|The relative risk could not be assessed due to zero incidence in the treatment group||||||0.11
72467157|NCT03831854|144457925|SUPERIORITY||Median Difference (Final Values)|-2.3||||0.63|TWO_SIDED|98.5|-9.5|5.0|||Wilcoxon (Mann-Whitney)|||||5.0|-9.5|0.63
72467158|NCT03831854|144457926|SUPERIORITY||Mean Difference (Final Values)|0.5||||0.58|TWO_SIDED|98.3|-1.7|2.6|||t-test, 2 sided|||||2.6|-1.7|0.58
72467159|NCT03831854|144457927|SUPERIORITY||Risk Ratio (RR)|1.0||||1|TWO_SIDED|98.3|0.3|3.8|||Chi-squared|||||3.8|0.3|1.0
72467160|NCT03305809|144457932|SUPERIORITY||Posterior Mean Difference|-0.89|||||TWO_SIDED|95.0|-2.776|0.969|||||Analyses were conducted using a bayesian mixed-model repeated measures (MMRM), and posterior mean change difference is reported.|||0.969|-2.776|
72467161|NCT03305809|144457932|SUPERIORITY||Posterior Mean Difference|-0.08|||||TWO_SIDED|95.0|-1.996|1.879|||||Analyses were conducted using a bayesian MMRM, and posterior mean change difference is reported.|||1.879|-1.996|
72467162|NCT03305809|144457932|SUPERIORITY||Posterior Mean Difference|-0.78|||||TWO_SIDED|95.0|-2.873|1.277|||||Analyses were conducted using a bayesian MMRM, and posterior mean change difference is reported.|||1.277|-2.873|
72467163|NCT03305809|144457933|SUPERIORITY||Mean Difference (Net)|-0.2||||0.273|TWO_SIDED|95.0|-0.54|0.15|||Mixed Models Analysis|||||0.15|-0.54|0.273
72467164|NCT03305809|144457933|SUPERIORITY||Mean Difference (Net)|-0.7|||<|0.001|TWO_SIDED|95.0|-1.02|-0.3|||Mixed Models Analysis|||||-0.30|-1.02|<0.001
72467165|NCT03305809|144457933|SUPERIORITY||Mean Difference (Net)|-0.9|||<|0.001|TWO_SIDED|95.0|-1.29|-0.53|||Mixed Models Analysis|||||-0.53|-1.29|< 0.001
72467166|NCT03305809|144457934|SUPERIORITY||Mean Difference (Net)|-70.71|STANDARD_ERROR_OF_MEAN|68.495||0.303|TWO_SIDED|95.0|-205.53|64.11|||Mixed Models Analysis|||||64.11|-205.53|0.303
72467167|NCT03305809|144457934|SUPERIORITY||Median Difference (Net)|-107.02|STANDARD_ERROR_OF_MEAN|69.647||0.125|TWO_SIDED|95.0|-244.09|30.06|||Mixed Models Analysis|||||30.06|-244.09|0.125
72467168|NCT03305809|144457934|SUPERIORITY||Mean Difference (Net)|-123.72|STANDARD_ERROR_OF_MEAN|72.892||0.091|TWO_SIDED|95.0|-267.18|19.74|||Mixed Models Analysis|||||19.74|-267.18|0.091
72467169|NCT03305809|144457935|SUPERIORITY||Mean Difference (Net)|-0.4|STANDARD_ERROR_OF_MEAN|0.985||0.686|TWO_SIDED|95.0|-2.34|1.54|||Mixed Models Analysis|||||1.54|-2.34|0.686
72467170|NCT03305809|144457935|SUPERIORITY||Mean Difference (Net)|-0.71|STANDARD_ERROR_OF_MEAN|1.011||0.485|TWO_SIDED|95.0|-2.7|1.28|||Mixed Models Analysis|||||1.28|-2.70|0.485
72467171|NCT03305809|144457935|SUPERIORITY||Mean Difference (Net)|-0.89|STANDARD_ERROR_OF_MEAN|1.064||0.406|TWO_SIDED|95.0|-2.98|1.21|||Mixed Models Analysis|||||1.21|-2.98|0.406
72467172|NCT03305809|144457936|SUPERIORITY||Mean Difference (Net)|0.44|STANDARD_ERROR_OF_MEAN|0.603||0.464|TWO_SIDED|95.0|-0.74|1.63|||Mixed Models Analysis|||||1.63|-0.74|0.464
72467173|NCT03305809|144457936|SUPERIORITY||Mean Difference (Net)|0.22|STANDARD_ERROR_OF_MEAN|0.623||0.72|TWO_SIDED|95.0|-1.0|1.45|||Mixed Models Analysis|||||1.45|-1.00|0.720
72467174|NCT03305809|144457936|SUPERIORITY||Mean Difference (Net)|0.95|STANDARD_ERROR_OF_MEAN|0.655||0.149|TWO_SIDED|95.0|-0.34|2.24|||Mixed Models Analysis|||||2.24|-0.34|0.149
72467175|NCT03305809|144457937|SUPERIORITY||Mean Difference (Net)|-0.62|STANDARD_ERROR_OF_MEAN|1.213||0.607|TWO_SIDED|95.0|-3.01|1.76|||Mixed Models Analysis|||Total Score||1.76|-3.01|0.607
72467176|NCT03305809|144457937|SUPERIORITY||Mean Difference (Net)|-1.7|STANDARD_ERROR_OF_MEAN|1.265||0.18|TWO_SIDED|95.0|-4.19|0.79|||Mixed Models Analysis|||Total Score||0.79|-4.19|0.180
72467177|NCT03305809|144457937|SUPERIORITY||Mean Difference (Net)|-0.75|STANDARD_ERROR_OF_MEAN|1.325||0.572|TWO_SIDED|95.0|-3.36|1.86|||Mixed Models Analysis|||Total Score||1.86|-3.36|0.572
72467178|NCT03305809|144457937|SUPERIORITY||Mean Difference (Net)|-0.17|STANDARD_ERROR_OF_MEAN|0.173||0.32|TWO_SIDED|95.0|-0.51|0.17|||Mixed Models Analysis|||Delusions||0.17|-0.51|0.320
72467179|NCT03305809|144457937|SUPERIORITY||Mean Difference (Net)|-0.38|STANDARD_ERROR_OF_MEAN|0.18||0.037|TWO_SIDED|95.0|-0.73|-0.02|||Mixed Models Analysis|||Delusions||-0.02|-0.73|0.037
72467180|NCT03305809|144457937|SUPERIORITY||Mean Difference (Net)|-0.11|STANDARD_ERROR_OF_MEAN|0.19||0.558|TWO_SIDED|95.0|-0.49|0.26|||Mixed Models Analysis|||Delusions||0.26|-0.49|0.558
72467181|NCT03305809|144457937|SUPERIORITY||Mean Difference (Net)|-0.02|STANDARD_ERROR_OF_MEAN|0.182||0.924|TWO_SIDED|95.0|-0.38|0.34|||Mixed Models Analysis|||Hallucinations||0.34|-0.38|0.924
72467182|NCT03305809|144457937|SUPERIORITY||Mean Difference (Net)|-0.36|STANDARD_ERROR_OF_MEAN|0.189||0.061|TWO_SIDED|95.0|-0.73|0.02|||Mixed Models Analysis|||Hallucinations||0.02|-0.73|0.061
72467183|NCT03305809|144457937|SUPERIORITY||Mean Difference (Net)|-0.29|STANDARD_ERROR_OF_MEAN|0.199||0.148|TWO_SIDED|95.0|-0.68|0.1|||Mixed Models Analysis|||Hallucinations||0.10|-0.68|0.148
72467184|NCT03305809|144457937|SUPERIORITY||Mean Difference (Net)|-0.11|STANDARD_ERROR_OF_MEAN|0.18||0.552|TWO_SIDED|95.0|-0.46|0.25|||Mixed Models Analysis|||Agitation/Aggression||0.25|-0.46|0.552
72467185|NCT03305809|144457937|SUPERIORITY||Mean Difference (Net)|-0.06|STANDARD_ERROR_OF_MEAN|0.188||0.735|TWO_SIDED|95.0|-0.43|0.31|||Mixed Models Analysis|||Agitation/Aggression||0.31|-0.43|0.735
72467186|NCT03305809|144457937|SUPERIORITY||Mean Difference (Net)|-0.24|STANDARD_ERROR_OF_MEAN|0.197||0.224|TWO_SIDED|95.0|-0.63|0.15|||Mixed Models Analysis|||Agitation/Aggression||0.15|-0.63|0.224
72467187|NCT03305809|144457937|SUPERIORITY||Mean Difference (Net)|0.06|STANDARD_ERROR_OF_MEAN|0.216||0.783|TWO_SIDED|95.0|-0.37|0.48|||Mixed Models Analysis|||Depression/Dysphoria||0.48|-0.37|0.783
72467188|NCT03305809|144457937|SUPERIORITY||Mean Difference (Net)|-0.11|STANDARD_ERROR_OF_MEAN|0.226||0.64|TWO_SIDED|95.0|-0.55|0.34|||Mixed Models Analysis|||Depression/Dysphoria||0.34|-0.55|0.640
72467189|NCT03305809|144457937|SUPERIORITY||Mean Difference (Net)|-0.13|STANDARD_ERROR_OF_MEAN|0.236||0.592|TWO_SIDED|95.0|-0.59|0.34|||Mixed Models Analysis|||Depression/Dysphoria||0.34|-0.59|0.592
72467190|NCT03305809|144457937|SUPERIORITY||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|0.197||0.993|TWO_SIDED|95.0|-0.39|0.39|||Mixed Models Analysis|||Anxiety||0.39|-0.39|0.993
72503655|NCT01287117|144538387|SUPERIORITY_OR_OTHER||Least squares mean difference|-5.73|||<|0.0001|TWO_SIDED|95.0|-7.59|-3.87||A pre-specified hierarchical order of testing was employed to adjust for the comparison of multiple omalizumab groups to the placebo group in order to maintain an overall type I error rate of 0.05 (2-sided) within each dose.|ANCOVA|Covariates included in the analysis were baseline weekly size of largest hive score (\< median vs ≥ median) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis was that there was no difference between the placebo and the omalizumab 300 mg groups.||-3.87|-7.59|<0.0001
72503656|NCT01287117|144538388|SUPERIORITY_OR_OTHER||Least squares mean difference|0.26||||0.7956|TWO_SIDED|95.0|-1.76|2.28||A pre-specified hierarchical order of testing was employed to adjust for the comparison of multiple omalizumab groups to the placebo group in order to maintain an overall type I error rate of 0.05 (2-sided) within each dose.|ANCOVA|Covariates included in the analysis were baseline overall DLQI score (\< median vs ≥ median) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis was that there was no difference between the placebo and the omalizumab 75 mg groups. The p-value was not evaluated for statistical significance in accordance with the type I error rate control plan.||2.28|-1.76|0.7956
72564727|NCT04019054|144660983|OTHER|This was a goodness of fit test of a multi-level model, fit was tested using a wald chi-square test.|||||<|0.001||||||a priori threshold for significance was p=0.05.|Chi-squared|This was specifically a wald chi-square test, performed in Stata for the purpose of assessing goodness-of-fit of a mixed effects model||Goodness of fit test of a two-variable negative binomial multi-level model of maximum distress as a function of step and group. This multi-level model was generated using the menbreg function in Stata 16||||<0.001
72564728|NCT04019054|144660983|SUPERIORITY|||||||0.024||||||a priori threshold for significance of p=0.05|Mixed Models Analysis|||This statistical analysis involved testing of the step-by-timepoint interaction in the two-variable negative binomial model of maximum distress as a function of step and group.||||0.024
72564729|NCT04625062|144660985|SUPERIORITY||Mean Difference (Final Values)|0.49||||0.72|TWO_SIDED||||||paired t-test, two-tailed|df = 6|Traditional treatment condition - biofeedback treatment condition|||||.72
72467191|NCT03305809|144457937|SUPERIORITY||Mean Difference (Net)|0.22|STANDARD_ERROR_OF_MEAN|0.205||0.29|TWO_SIDED|95.0|-0.19|0.62|||Mixed Models Analysis|||Anxiety||0.62|-0.19|0.290
72467192|NCT03305809|144457937|SUPERIORITY||Mean Difference (Net)|-0.08|STANDARD_ERROR_OF_MEAN|0.215||0.722|TWO_SIDED|95.0|-0.5|0.35|||Mixed Models Analysis|||Anxiety||0.35|-0.50|0.722
72564730|NCT01682148|144660986|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Based on a responder rate (π) of 63% in the reference group, a clinically relevant delta (Δ) of 17%, α=2.5% (one sided) and power=80%, the sample size estimate yielded 122 valid subjects per group. Including a 10% addition for premature withdrawals, 136 subjects per group were necessary to be randomised in the study (i.e., a total of 272 subjects).|Treatment difference|-0.1673||||0.0986|TWO_SIDED|95.0|-0.363|0.0284||Based on a generalised linear model including factors for treatment.|Generalised linear model||Difference of the two clinical success rates (NMJ Targeted minus Current Clinical Practice).|A responder was defined as a subject with at least one level decrease on the MAS scale.||0.0284|-0.3630|0.0986
72564731|NCT01682148|144660986|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Based on a π of 63% in the reference group, a clinically relevant Δ of 17%, α=2.5% (one sided) and power=80%, the sample size estimate yielded 122 valid subjects per group. Including a 10% addition for premature withdrawals, 136 subjects per group were necessary to be randomised in the study (i.e., a total of 272 subjects).|Treatment difference|-0.1673||||0.5682|TWO_SIDED|95.0|-0.363|0.0284||Based on a generalised linear model including factors for spasticity pattern.|Generalised linear model||Difference of the two clinical success rates (NMJ Targeted minus Current Clinical Practice).|A responder was defined as a subject with at least one level decrease on the MAS scale.||0.0284|-0.3630|0.5682
72467193|NCT03305809|144457937|SUPERIORITY||Mean Difference (Net)|-0.11|STANDARD_ERROR_OF_MEAN|0.097||0.246|TWO_SIDED|95.0|-0.3|0.08|||Mixed Models Analysis|||Elation/Euphoria||0.08|-0.30|0.246
72503657|NCT01287117|144538388|SUPERIORITY_OR_OTHER||Least squares mean difference|-1.31||||0.2286|TWO_SIDED|95.0|-3.46|0.84||A pre-specified hierarchical order of testing was employed to adjust for the comparison of multiple omalizumab groups to the placebo group in order to maintain an overall type I error rate of 0.05 (2-sided) within each dose.|ANCOVA|Covariates included in the analysis were baseline overall DLQI score (\< median vs ≥ median) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis was that there was no difference between the placebo and the omalizumab 150 mg groups.||0.84|-3.46|0.2286
72621790|NCT00581100|144773962|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value from generalized linear models for correlated data using Generalized Estimating Equations (GEE), with treatment and visits as fixed factors. Model for proportion = \[Group visit Group\*visit\].|GEE model|||Week 12||||<0.001
72467194|NCT03305809|144457937|SUPERIORITY||Mean Difference (Net)|-0.14|STANDARD_ERROR_OF_MEAN|0.101||0.175|TWO_SIDED|95.0|-0.34|0.06|||Mixed Models Analysis|||Elation/Euphoria||0.06|-0.34|0.175
72467195|NCT03305809|144457937|SUPERIORITY||Mean Difference (Net)|-0.07|STANDARD_ERROR_OF_MEAN|0.106||0.482|TWO_SIDED|95.0|-0.28|0.13|||Mixed Models Analysis|||Elation/Euphoria||0.13|-0.28|0.482
72467196|NCT03305809|144457937|SUPERIORITY||Mean Difference (Net)|-0.45|STANDARD_ERROR_OF_MEAN|0.266||0.091|TWO_SIDED|95.0|-0.97|0.07|||Mixed Models Analysis|||Apathy/Indifference||0.07|-0.97|0.091
72467197|NCT03305809|144457937|SUPERIORITY||Mean Difference (Net)|-0.32|STANDARD_ERROR_OF_MEAN|0.278||0.248|TWO_SIDED|95.0|-0.87|0.23|||Mixed Models Analysis|||Apathy/Indifference||0.23|-0.87|0.248
72467198|NCT03305809|144457937|SUPERIORITY||Mean Difference (Net)|-0.19|STANDARD_ERROR_OF_MEAN|0.29||0.516|TWO_SIDED|95.0|-0.76|0.38|||Mixed Models Analysis|||Apathy/Indifference||0.38|-0.76|0.516
72467199|NCT03305809|144457937|SUPERIORITY||Mean Difference (Net)|0.02|STANDARD_ERROR_OF_MEAN|0.114||0.875|TWO_SIDED|95.0|-0.21|0.24|||Mixed Models Analysis|||Disinhibition||0.24|-0.21|0.875
72467200|NCT03305809|144457937|SUPERIORITY||Mean Difference (Net)|0.34|STANDARD_ERROR_OF_MEAN|0.119||0.005|TWO_SIDED|95.0|0.1|0.57|||Mixed Models Analysis|||Disinhibition||0.57|0.10|0.005
72467201|NCT03305809|144457937|SUPERIORITY||Mean Difference (Net)|0.04|STANDARD_ERROR_OF_MEAN|0.125||0.761|TWO_SIDED|95.0|-0.21|0.28|||Mixed Models Analysis|||Disinhibition||0.28|-0.21|0.761
72467202|NCT03305809|144457937|SUPERIORITY||Mean Difference (Net)|-0.24|STANDARD_ERROR_OF_MEAN|0.181||0.183|TWO_SIDED|95.0|-0.6|0.12|||Mixed Models Analysis|||Irritability/Lability||0.12|-0.60|0.183
72394569|NCT02310568|144295791|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|1.9||0.771|TWO_SIDED|90.0|-3.7|2.6|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 3: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1.||2.6|-3.7|0.771
72394570|NCT02310568|144295792|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.75|||||TWO_SIDED|90.0|0.45|1.26|||Regression, Logistic|||(PF-06372865 7.5 mg - Placebo). Stage 1: Logistic regression model included treatment as fixed effect, and the baseline as covariate. Baseline for Stage 1 is Day 1 and for Stage 2 is Day 28.||1.26|0.45|
72394571|NCT02310568|144295792|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.6|||||TWO_SIDED|90.0|0.23|1.54|||Regression, Logistic|||(PF-06372865 2.5 mg - Placebo). Stage 1: Logistic regression model included treatment as fixed effect, and the baseline as covariate. Baseline for Stage 1 is Day 1 and for Stage 2 is Day 28.||1.54|0.23|
72467203|NCT03305809|144457937|SUPERIORITY||Mean Difference (Net)|-0.06|STANDARD_ERROR_OF_MEAN|0.189||0.765|TWO_SIDED|95.0|-0.43|0.31|||Mixed Models Analysis|||Irritability/Lability||0.31|-0.43|0.765
72467204|NCT03305809|144457937|SUPERIORITY||Mean Difference (Net)|0.21|STANDARD_ERROR_OF_MEAN|0.198||0.279|TWO_SIDED|95.0|-0.18|0.61|||Mixed Models Analysis|||Irritability/Lability||0.61|-0.18|0.279
72467205|NCT03305809|144457937|SUPERIORITY||Mean Difference (Net)|0.17|STANDARD_ERROR_OF_MEAN|0.147||0.252|TWO_SIDED|95.0|-0.12|0.46|||Mixed Models Analysis|||Aberrant Motor Behavior||0.46|-0.12|0.252
72467206|NCT03305809|144457937|SUPERIORITY||Mean Difference (Net)|-0.1|STANDARD_ERROR_OF_MEAN|0.154||0.526|TWO_SIDED|95.0|-0.4|0.2|||Mixed Models Analysis|||Aberrant Motor Behavior||0.20|-0.40|0.526
72467207|NCT03305809|144457937|SUPERIORITY||Mean Difference (Net)|0.04|STANDARD_ERROR_OF_MEAN|0.161||0.8|TWO_SIDED|95.0|-0.28|0.36|||Mixed Models Analysis|||Aberrant Motor Behavior||0.36|-0.28|0.800
72467208|NCT03305809|144457937|SUPERIORITY||Mean Difference (Net)|0.2|STANDARD_ERROR_OF_MEAN|0.4||0.623|TWO_SIDED|95.0|-0.59|0.98|||Mixed Models Analysis|||Sleep/Nighttime Behavior Disorders||0.98|-0.59|0.623
72467209|NCT03305809|144457937|SUPERIORITY||Mean Difference (Net)|-0.39|STANDARD_ERROR_OF_MEAN|0.418||0.354|TWO_SIDED|95.0|-1.21|0.44|||Mixed Models Analysis|||Sleep/Nighttime Behavior Disorders||0.44|-1.21|0.354
72467210|NCT03305809|144457937|SUPERIORITY||Mean Difference (Net)|-0.11|STANDARD_ERROR_OF_MEAN|0.437||0.809|TWO_SIDED|95.0|-0.97|0.75|||Mixed Models Analysis|||Sleep/Nighttime Behavior Disorders||0.75|-0.97|0.809
72467211|NCT03305809|144457937|SUPERIORITY||Mean Difference (Net)|-0.1|STANDARD_ERROR_OF_MEAN|0.376||0.79|TWO_SIDED|95.0|-0.84|0.64|||Mixed Models Analysis|||Appetite/Eating Disorders||0.64|-0.84|0.790
72467212|NCT03305809|144457937|SUPERIORITY||Mean Difference (Net)|-0.42|STANDARD_ERROR_OF_MEAN|0.392||0.28|TWO_SIDED|95.0|-1.2|0.35|||Mixed Models Analysis|||Appetite/Eating Disorders||0.35|-1.20|0.280
72621791|NCT00581100|144773962|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value from generalized linear models for correlated data using Generalized Estimating Equations (GEE), with treatment and visits as fixed factors. Model for proportion = \[Group visit Group\*visit\].|GEE model|||Week 12||||<0.001
72467213|NCT03305809|144457937|SUPERIORITY||Mean Difference (Net)|0.11|STANDARD_ERROR_OF_MEAN|0.412||0.797|TWO_SIDED|95.0|-0.7|0.92|||Mixed Models Analysis|||Appetite/Eating Disorders||0.92|-0.70|0.797
72467214|NCT03305809|144457938|SUPERIORITY||Mean Difference (Net)|-0.71|STANDARD_ERROR_OF_MEAN|0.61||0.247|TWO_SIDED|95.0|-1.91|0.49|||Mixed Models Analysis|||||0.49|-1.91|0.247
72621792|NCT00581100|144773962|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value from generalized linear models for correlated data using Generalized Estimating Equations (GEE), with treatment and visits as fixed factors. Model for proportion = \[Group visit Group\*visit\].|GEE model|||Week 24||||<0.001
72394572|NCT02310568|144295792|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.26|||||TWO_SIDED|90.0|0.69|2.32|||Regression, Logistic|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Stage 1: Logistic regression model included treatment as fixed effect, and the baseline as covariate. Baseline for Stage 1 is Day 1 and for Stage 2 is Day 28.||2.32|0.69|
72467215|NCT03305809|144457938|SUPERIORITY||Mean Difference (Net)|-0.88|STANDARD_ERROR_OF_MEAN|0.631||0.164|TWO_SIDED|95.0|-2.12|0.36|||Mixed Models Analysis|||||0.36|-2.12|0.164
72467216|NCT03305809|144457938|SUPERIORITY||Mean Difference (Net)|-1.59|STANDARD_ERROR_OF_MEAN|0.663||0.017|TWO_SIDED|95.0|-2.9|-0.29|||Mixed Models Analysis|||||-0.29|-2.90|0.017
72467217|NCT03305809|144457939|SUPERIORITY||Mean Difference (Net)|-6.41|STANDARD_ERROR_OF_MEAN|2.86||0.026|TWO_SIDED|95.0|-12.04|-0.77|||Mixed Models Analysis|||||-0.77|-12.04|0.026
72467218|NCT03305809|144457939|SUPERIORITY||Mean Difference (Net)|-7.39|STANDARD_ERROR_OF_MEAN|2.969||0.014|TWO_SIDED|95.0|-13.24|-1.53|||Mixed Models Analysis|||||-1.53|-13.24|0.014
72467219|NCT03305809|144457939|SUPERIORITY||Mean Difference (Net)|-10.6|STANDARD_ERROR_OF_MEAN|3.104|<|0.001|TWO_SIDED|95.0|-16.72|-4.48|||Mixed Models Analysis|||||-4.48|-16.72|<0.001
72467220|NCT03305809|144457940|SUPERIORITY||Mean Difference (Net)|0.56|STANDARD_ERROR_OF_MEAN|1.362||0.683|TWO_SIDED|95.0|-2.13|3.24|||Mixed Models Analysis|||||3.24|-2.13|0.683
72467221|NCT03305809|144457940|SUPERIORITY||Mean Difference (Net)|2.41|STANDARD_ERROR_OF_MEAN|1.413||0.089|TWO_SIDED|95.0|-0.37|5.19|||Mixed Models Analysis|||||5.19|-0.37|0.089
72467222|NCT03305809|144457940|SUPERIORITY||Mean Difference (Net)|1.56|STANDARD_ERROR_OF_MEAN|1.489||0.294|TWO_SIDED|95.0|-1.37|4.49|||Mixed Models Analysis|||||4.49|-1.37|0.294
72467223|NCT03305809|144457941|SUPERIORITY||Mean Difference (Net)|0.63|STANDARD_ERROR_OF_MEAN|0.389||0.105|TWO_SIDED|95.0|-0.13|1.4|||Mixed Models Analysis|||||1.40|-0.13|0.105
72467224|NCT03305809|144457941|SUPERIORITY||Mean Difference (Net)|1.07|STANDARD_ERROR_OF_MEAN|0.406||0.009|TWO_SIDED|95.0|0.27|1.87|||Mixed Models Analysis|||||1.87|0.27|0.009
72467225|NCT03305809|144457941|SUPERIORITY||Mean Difference (Net)|0.49|STANDARD_ERROR_OF_MEAN|0.428||0.253|TWO_SIDED|95.0|-0.35|1.33|||Mixed Models Analysis|||||1.33|-0.35|0.253
72467226|NCT03305809|144457942|SUPERIORITY||Mean Difference (Net)|-1.74|STANDARD_ERROR_OF_MEAN|0.923||0.061|TWO_SIDED|95.0|-3.56|0.08|||Mixed Models Analysis|||Motor Experiences of Daily Living||0.08|-3.56|0.061
72467227|NCT03305809|144457942|SUPERIORITY||Mean Difference (Net)|-2.37|STANDARD_ERROR_OF_MEAN|0.96||0.014|TWO_SIDED|95.0|-4.26|-0.47|||Mixed Models Analysis|||Motor Experiences of Daily Living||-0.47|-4.26|0.014
72467228|NCT03305809|144457942|SUPERIORITY||Mean Difference (Net)|-3.5|STANDARD_ERROR_OF_MEAN|1.013|<|0.001|TWO_SIDED|95.0|-5.5|-1.51|||Mixed Models Analysis|||Motor Experiences of Daily Living||-1.51|-5.50|<0.001
72503658|NCT01287117|144538388|SUPERIORITY_OR_OTHER||Least squares mean difference|-4.08|||<|0.0001|TWO_SIDED|95.0|-5.96|-2.2||A pre-specified hierarchical order of testing was employed to adjust for the comparison of multiple omalizumab groups to the placebo group in order to maintain an overall type I error rate of 0.05 (2-sided) within each dose.|ANCOVA|Covariates included in the analysis were baseline overall DLQI score (\< median vs ≥ median) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis was that there was no difference between the placebo and the omalizumab 300 mg groups.||-2.20|-5.96|<0.0001
72503659|NCT01287117|144538389|SUPERIORITY_OR_OTHER|||||||0.4867||95.0||||A pre-specified hierarchical order of testing was employed to adjust for the comparison of multiple omalizumab groups to the placebo group in order to maintain an overall type I error rate of 0.05 (2-sided) within each dose.|Stratified Wilcoxon|Stratification variables included in the analysis were presence of angioedema at baseline (yes vs no) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis was that there was no difference between the placebo and the omalizumab 75 mg groups. The p-value was not evaluated for statistical significance in accordance with the type I error rate control plan.||||0.4867
72503660|NCT01287117|144538389|SUPERIORITY_OR_OTHER|||||||0.1747||95.0||||A pre-specified hierarchical order of testing was employed to adjust for the comparison of multiple omalizumab groups to the placebo group in order to maintain an overall type I error rate of 0.05 (2-sided) within each dose.|Stratified Wilcoxon|Stratification variables included in the analysis were presence of angioedema at baseline (yes vs no) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis was that there was no difference between the placebo and the omalizumab 150 mg groups. The p-value was not evaluated for statistical significance in accordance with the type I error rate control plan.||||0.1747
72503661|NCT01287117|144538389|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||A pre-specified hierarchical order of testing was employed to adjust for the comparison of multiple omalizumab groups to the placebo group in order to maintain an overall type I error rate of 0.05 (2-sided) within each dose.|Stratified Wilcoxon|Stratification variables included in the analysis were presence of angioedema at baseline (yes vs no) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis was that there was no difference between the placebo and the omalizumab 300 mg groups.||||<0.0001
72503662|NCT01287117|144538390|SUPERIORITY_OR_OTHER|||||||0.458||95.0||||A pre-specified hierarchical order of testing was employed to adjust for the comparison of multiple omalizumab groups to the placebo group in order to maintain an overall type I error rate of 0.05 (2-sided) within each dose.|Cochran-Mantel-Haenszel|Covariates included in the analysis were baseline UAS7 (\< median vs ≥ median) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis was that there was no difference between the placebo and the omalizumab 75 mg groups. The p-value was not evaluated for statistical significance in accordance with the type I error rate control plan.||||0.4580
72503663|NCT01287117|144538390|SUPERIORITY_OR_OTHER|||||||0.2087||95.0||||A pre-specified hierarchical order of testing was employed to adjust for the comparison of multiple omalizumab groups to the placebo group in order to maintain an overall type I error rate of 0.05 (2-sided) within each dose.|Cochran-Mantel-Haenszel|Covariates included in the analysis were baseline UAS7 (\< median vs ≥ median) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis was that there was no difference between the placebo and the omalizumab 150 mg groups. The p-value was not evaluated for statistical significance in accordance with the type I error rate control plan.||||0.2087
72503664|NCT01287117|144538390|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||A pre-specified hierarchical order of testing was employed to adjust for the comparison of multiple omalizumab groups to the placebo group in order to maintain an overall type I error rate of 0.05 (2-sided) within each dose.|Cochran-Mantel-Haenszel|Covariates included in the analysis were baseline UAS7 (\< median vs ≥ median) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis was that there was no difference between the placebo and the omalizumab 300 mg groups.||||<0.0001
72503665|NCT02680301|144538409|EQUIVALENCE|Wilcoxon sign- rank test values with ranks from change in cream efficacy ratings minus change in ointment efficacy ratings.||||||0.22|||||||Wilcoxon (Mann-Whitney)|||||||0.22
72504846|NCT03551522|144540604|OTHER|The LS Means, confidence intervals, and p-values come from an ANCOVA model with relative (percent) change from baseline as the dependent variable and treatment and stratification groups (diabetic status and fibrosis stage) as factors and baseline as a covariate.|LS Mean of Difference|7.78||||0.2313|TWO_SIDED|95.0|-5.01|20.58|||ANCOVA|||||20.58|-5.01|0.2313
72467229|NCT03305809|144457942|SUPERIORITY||Mean Difference (Net)|-3.27|STANDARD_ERROR_OF_MEAN|1.822||0.074|TWO_SIDED|95.0|-6.86|0.32|||Mixed Models Analysis|||Motor Exam||0.32|-6.86|0.074
72467230|NCT03305809|144457942|SUPERIORITY||Mean Difference (Net)|-3.27|STANDARD_ERROR_OF_MEAN|1.891||0.085|TWO_SIDED|95.0|-7.0|0.45|||Mixed Models Analysis|||Motor Exam||0.45|-7.00|0.085
72467231|NCT03305809|144457942|SUPERIORITY||Mean Difference (Net)|-4.23|STANDARD_ERROR_OF_MEAN|1.959||0.032|TWO_SIDED|95.0|-8.09|-0.37|||Mixed Models Analysis|||Motor Exam||-0.37|-8.09|0.032
72467232|NCT03305809|144457944|SUPERIORITY||Mean Difference (Net)|0.3||||0.898|TWO_SIDED|95.0|-4.92|5.61|||Mixed Models Analysis|||Sitting Systolic Blood Pressure||5.61|-4.92|0.898
72467233|NCT03305809|144457944|SUPERIORITY||Mean Difference (Net)|0.6||||0.821|TWO_SIDED|95.0|-4.71|5.94|||Mixed Models Analysis|||Sitting Systolic Blood Pressure||5.94|-4.71|0.821
72467234|NCT03305809|144457944|SUPERIORITY||Mean Difference (Net)|9.4|||<|0.001|TWO_SIDED|95.0|4.11|14.61|||Mixed Models Analysis|||Sitting Systolic Blood Pressure||14.61|4.11|<0.001
72467235|NCT03305809|144457944|SUPERIORITY||Mean Difference (Net)|0.3||||0.805|TWO_SIDED|95.0|-2.4|3.08|||Mixed Models Analysis|||Sitting Diastolic Blood Pressure||3.08|-2.40|0.805
72467236|NCT03305809|144457944|SUPERIORITY||Mean Difference (Net)|0.9||||0.513|TWO_SIDED|95.0|-1.85|3.69|||Mixed Models Analysis|||Sitting Diastolic Blood Pressure||3.69|-1.85|0.513
72467237|NCT03305809|144457944|SUPERIORITY||Mean Difference (Net)|3.6||||0.011|TWO_SIDED|95.0|0.83|6.28|||Mixed Models Analysis|||Sitting Diastolic Blood Pressure||6.28|0.83|0.011
72467238|NCT03305809|144457945|SUPERIORITY||Mean Difference (Net)|2.5||||0.065|TWO_SIDED|95.0|-0.16|5.08|||Mixed Models Analysis|||||5.08|-0.16|0.065
72467239|NCT03305809|144457945|SUPERIORITY||Mean Difference (Net)|3.6||||0.008|TWO_SIDED|95.0|0.93|6.21|||Mixed Models Analysis|||||6.21|0.93|0.008
72467240|NCT03305809|144457945|SUPERIORITY||Mean Difference (Net)|8.7|||<|0.001|TWO_SIDED|95.0|6.06|11.27|||Mixed Models Analysis|||||11.27|6.06|<0.001
72564732|NCT01682148|144660986|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Based on a π of 63% in the reference group, a clinically relevant Δ of 17%, α=2.5% (one sided) and power=80%, the sample size estimate yielded 122 valid subjects per group. Including a 10% addition for premature withdrawals, 136 subjects per group were necessary to be randomised in the study (i.e., a total of 272 subjects).|Treatment difference|-0.1673||||0.8543|TWO_SIDED|5.0|-0.363|0.0284||Based on a generalised linear model including factors for country.|Generalised linear model||Difference of the two clinical success rates (NMJ Targeted minus Current Clinical Practice).|A responder was defined as a subject with at least one level decrease on the MAS scale.||0.0284|-0.3630|0.8543
72621793|NCT00581100|144773962|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value from generalized linear models for correlated data using Generalized Estimating Equations (GEE), with treatment and visits as fixed factors. Model for proportion = \[Group visit Group\*visit\].|GEE model|||Week 24||||<0.001
72621794|NCT00581100|144773963|SUPERIORITY_OR_OTHER|||||||0.007||95.0||||P-value from generalized linear models for correlated data using Generalized Estimating Equations (GEE) with treatment and visits as fixed factors. Model for proportion=\[Group visit Group\*visit\].|GEE model|||Week 12||||0.007
72621795|NCT00581100|144773963|SUPERIORITY_OR_OTHER|||||||0.006||95.0||||P-value from generalized linear models for correlated data using Generalized Estimating Equations (GEE) with treatment and visits as fixed factors. Model for proportion=\[Group visit Group\*visit\].|GEE model|||Week 12||||0.006
72394573|NCT02310568|144295792|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.24|||||TWO_SIDED|90.0|0.27|5.78|||Regression, Logistic|||(PF-06372865 7.5 mg - Placebo). Stage 2: Logistic regression model included treatment as fixed effect, and the baseline as covariate. Baseline for Stage 1 is Day 1 and for Stage 2 is Day 28.||5.78|0.27|
72467241|NCT03305809|144457946|SUPERIORITY||Mean Difference (Net)|1.6||||0.339|TWO_SIDED|95.0|-1.72|4.99|||Mixed Models Analysis|||Sitting Systolic Blood Pressure||4.99|-1.72|0.339
72467242|NCT03305809|144457946|SUPERIORITY||Mean Difference (Net)|1.2||||0.486|TWO_SIDED|95.0|-2.26|4.73|||Mixed Models Analysis|||Sitting Systolic Blood Pressure||4.73|-2.26|0.486
72467243|NCT03305809|144457946|SUPERIORITY||Mean Difference (Net)|4.2||||0.024|TWO_SIDED|95.0|0.56|7.81|||Mixed Models Analysis|||Sitting Systolic Blood Pressure||7.81|0.56|0.024
72467244|NCT03305809|144457946|SUPERIORITY||Mean Difference (Net)|-0.1||||0.935|TWO_SIDED|95.0|-2.04|1.88|||Mixed Models Analysis|||Sitting Diastolic Blood Pressure||1.88|-2.04|0.935
72503666|NCT00095121|144538415|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||End of double-blind treatment|Fisher Exact|||After unblinding the results, due to the small number of responders in the placebo group, it was determined that a statistical exact test would be more appropriate in the evaluation of treatment group differences than the originally planned 95% confidence intervals of the difference between the groups. Therefore, the results were analyzed by study visit, and a Fisher exact test was used to evaluate treatment differences between the adefovir dipivoxil and placebo groups.||||<0.001
72503667|NCT00095121|144538431|SUPERIORITY_OR_OTHER|||||||0.051||||||Comparison of HBeAg Loss|Fisher Exact|||||||0.051
72467245|NCT03305809|144457946|SUPERIORITY||Mean Difference (Net)|0.7||||0.505|TWO_SIDED|95.0|-1.34|2.72|||Mixed Models Analysis|||Sitting Diastolic Blood Pressure||2.72|-1.34|0.505
72467246|NCT03305809|144457946|SUPERIORITY||Mean Difference (Net)|1.22||||0.266|TWO_SIDED|95.0|-0.91|3.3|||Mixed Models Analysis|||Sitting Diastolic Blood Pressure||3.30|-0.91|0.266
72467247|NCT03305809|144457947|SUPERIORITY||Mean Difference (Net)|0.6||||0.55|TWO_SIDED|95.0|-1.28|2.41|||Mixed Models Analysis|||||2.41|-1.28|0.550
72503668|NCT00095121|144538431|SUPERIORITY_OR_OTHER|||||||0.051||||||Comparison of HBeAg Seroconversion|Fisher Exact|||||||0.051
72503669|NCT02975349|144538454|SUPERIORITY||Lesion rate ratio|1.45||||0.2947|TWO_SIDED|95.0|0.72|2.91|||Negative Binomial model|||||2.91|0.72|0.2947
72503670|NCT02975349|144538454|SUPERIORITY||Lesion rate ratio|0.3||||0.0015|TWO_SIDED|95.0|0.14|0.63|||Negative Binomial model|||||0.63|0.14|0.0015
72503671|NCT02975349|144538454|SUPERIORITY||Lesion rate ratio|0.44||||0.0313|TWO_SIDED|95.0|0.21|0.93|||Negative Binomial model|||||0.93|0.21|0.0313
72503672|NCT02975349|144538455|SUPERIORITY||Qualified relapse rate ratio|1.66||||0.2692|TWO_SIDED|95.0|0.67|4.09|||Negative Binomial model|||||4.09|0.67|0.2692
72467248|NCT03305809|144457947|SUPERIORITY||Mean Difference (Net)|1.8||||0.069|TWO_SIDED|95.0|-0.14|3.68|||Mixed Models Analysis|||||3.68|-0.14|0.069
72467249|NCT03305809|144457947|SUPERIORITY||Mean Difference (Net)|2.9||||0.005|TWO_SIDED|95.0|0.89|4.83|||Mixed Models Analysis|||||4.83|0.89|0.005
72467250|NCT03305809|144457948|SUPERIORITY||Mean Difference (Net)|-7.0||||0.045|TWO_SIDED|95.0|-13.92|-0.15|||Mixed Models Analysis|||Sitting Systolic Blood Pressure||-0.15|-13.92|0.045
72467251|NCT03305809|144457948|SUPERIORITY||Mean Difference (Net)|3.1||||0.39|TWO_SIDED|95.0|-4.05|10.32|||Mixed Models Analysis|||Sitting Systolic Blood Pressure||10.32|-4.05|0.390
72467252|NCT03305809|144457948|SUPERIORITY||Mean Difference (Net)|-1.1||||0.768|TWO_SIDED|95.0|-8.32|6.16|||Mixed Models Analysis|||Sitting Systolic Blood Pressure||6.16|-8.32|0.768
72467253|NCT03305809|144457948|SUPERIORITY||Mean Difference (Net)|-4.3||||0.041|TWO_SIDED|95.0|-8.48|-0.17|||Mixed Models Analysis|||Sitting Diastolic Blood Pressure||-0.17|-8.48|0.041
72467254|NCT03305809|144457948|SUPERIORITY||Mean Difference (Net)|-0.5||||0.802|TWO_SIDED|95.0|-4.81|3.72|||Mixed Models Analysis|||Sitting Diastolic Blood Pressure||3.72|-4.81|0.802
72467255|NCT03305809|144457948|SUPERIORITY||Mean Difference (Net)|-2.4||||0.284|TWO_SIDED|95.0|-6.67|1.97|||Mixed Models Analysis|||Sitting Diastolic Blood Pressure||1.97|-6.67|0.284
72467256|NCT03305809|144457949|SUPERIORITY||Mean Difference (Net)|0.0||||0.996|TWO_SIDED|95.0|-4.17|4.19|||Mixed Models Analysis|||||4.19|-4.17|0.996
72467257|NCT03305809|144457949|SUPERIORITY||Mean Difference (Net)|-0.7||||0.767|TWO_SIDED|95.0|-4.99|3.69|||Mixed Models Analysis|||||3.69|-4.99|0.767
72467258|NCT03305809|144457949|SUPERIORITY||Mean Difference (Net)|-0.6||||0.791|TWO_SIDED|95.0|-4.96|3.79|||Mixed Models Analysis|||||3.79|-4.96|0.791
72467259|NCT03305809|144457950|SUPERIORITY||Mean Difference (Net)|0.98||||0.312|TWO_SIDED|95.0|-0.93|2.88|||ANCOVA|||Week 12||2.88|-0.93|0.312
72467260|NCT03305809|144457950|SUPERIORITY||Mean Difference (Net)|1.03||||0.289|TWO_SIDED|95.0|-0.89|2.95|||ANCOVA|||Week 12||2.95|-0.89|0.289
72503673|NCT02975349|144538455|SUPERIORITY||Qualified relapse rate ratio|0.31||||0.0896|TWO_SIDED|95.0|0.08|1.2|||Negative Binomial model|||||1.20|0.08|0.0896
72394574|NCT02310568|144295792|SUPERIORITY_OR_OTHER||Odds Ratio, log|2.13|||||TWO_SIDED|90.0|0.19|24.51|||Regression, Logistic|||(PF-06372865 2.5 mg - Placebo). Stage 2: Logistic regression model included treatment as fixed effect, and the baseline as covariate. Baseline for Stage 1 is Day 1 and for Stage 2 is Day 28.||24.51|0.19|
72467261|NCT03305809|144457950|SUPERIORITY||Mean Difference (Net)|1.56||||0.141|TWO_SIDED|95.0|-0.53|3.65|||ANCOVA|||Week 12||3.65|-0.53|0.141
72467262|NCT03305809|144457950|SUPERIORITY||Mean Difference (Net)|0.06||||0.954|TWO_SIDED|95.0|-1.89|2.01|||ANCOVA|||Week 12||2.01|-1.89|0.954
72467263|NCT03305809|144457950|SUPERIORITY||Mean Difference (Net)|0.59||||0.584|TWO_SIDED|95.0|-1.53|2.7|||ANCOVA|||||2.70|-1.53|0.584
72467264|NCT03305809|144457950|SUPERIORITY||Mean Difference (Net)|0.53||||0.623|TWO_SIDED|95.0|-1.59|2.65|||ANCOVA|||Week 12||2.65|-1.59|0.623
72467265|NCT03305809|144457950|SUPERIORITY||Mean Difference (Net)|1.39||||0.256|TWO_SIDED|95.0|-1.02|3.79|||ANCOVA|||Follow-up||3.79|-1.02|0.256
72467266|NCT03305809|144457950|SUPERIORITY||Mean Difference (Net)|1.41||||0.258|TWO_SIDED|95.0|-1.04|3.86|||ANCOVA|||Follow-up||3.86|-1.04|0.258
72467267|NCT03305809|144457950|SUPERIORITY||Mean Difference (Net)|4.59|||<|0.001|TWO_SIDED|95.0|1.93|7.25|||ANCOVA|||Follow-up||7.25|1.93|<0.001
72467268|NCT03305809|144457950|SUPERIORITY||Mean Difference (Net)|0.02||||0.988|TWO_SIDED|95.0|-2.47|2.51|||ANCOVA|||Follow-up||2.51|-2.47|0.988
72467269|NCT03305809|144457950|SUPERIORITY||Mean Difference (Net)|3.2||||0.02|TWO_SIDED|95.0|0.51|5.9|||ANCOVA|||Follow-up||5.90|0.51|0.020
72503674|NCT02975349|144538455|SUPERIORITY||Qualified relapse rate ratio|0.23||||0.0633|TWO_SIDED|95.0|0.05|1.09|||Negative Binomial model|||||1.09|0.05|0.0633
72503675|NCT02975349|144538456|SUPERIORITY||Odds Ratio (OR)|0.75||||0.5609|TWO_SIDED|95.0|0.29|1.95|||Logistic model|||||1.95|0.29|0.5609
72503676|NCT02975349|144538456|SUPERIORITY||Odds Ratio (OR)|2.79||||0.0689|TWO_SIDED|95.0|0.92|8.41|||Logistic model|||||8.41|0.92|0.0689
72503677|NCT02975349|144538456|SUPERIORITY||Odds Ratio (OR)|2.08||||0.1767|TWO_SIDED|95.0|0.72|5.99|||Logistic model|||||5.99|0.72|0.1767
72503678|NCT02975349|144538457|SUPERIORITY||Hodges-Lehmann estimate|0.0||||0.407|TWO_SIDED|95.0|0.0|0.0|||Wilcoxon rank-sum test|||||0.00|0.00|0.4070
72503679|NCT02975349|144538457|SUPERIORITY||Hodges-Lehmann estimate|0.0||||0.5829|TWO_SIDED|95.0|0.0|0.0|||Wilcoxon rank-sum test|||||0.00|0.00|0.5829
72503680|NCT02975349|144538457|SUPERIORITY||Hodges-Lehmann estimate|0.0||||0.2732|TWO_SIDED|95.0|0.0|0.0|||Wilcoxon rank-sum test|||||0.00|0.00|0.2732
72503681|NCT02975349|144538469|SUPERIORITY||Lesion rate ratio|1.36||||0.3676|TWO_SIDED|95.0|0.7|2.65|||Negative Binomial|||||2.65|0.70|0.3676
72503682|NCT02975349|144538469|SUPERIORITY||Lesion rate ratio|0.27||||0.0005|TWO_SIDED|95.0|0.13|0.57|||Negative Binomial|||||0.57|0.13|0.0005
72503683|NCT02975349|144538469|SUPERIORITY||Lesion rate ratio|0.41||||0.0157|TWO_SIDED|95.0|0.2|0.85|||Negative Binomial|||||0.85|0.20|0.0157
72467270|NCT03305809|144457950|SUPERIORITY||Mean Difference (Net)|3.18||||0.022|TWO_SIDED|95.0|0.46|5.91|||ANCOVA|||Follow-up||5.91|0.46|0.022
72467271|NCT01660256|144457981|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.3|||<|0.001|TWO_SIDED||||||t-test, 2 sided|||||||<0.001
72467272|NCT01660256|144457982|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.5|||<|0.001|TWO_SIDED||||||t-test, 2 sided|||||||<0.001
72467273|NCT00551135|144457993|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0668|TWO_SIDED|||||Hochberg's adjustment applied to p-value; Hochberg's adjusted p-value was the primary analysis.|ANOVA|||LS Means from ANOVA model with terms of treatment, pooled center and baseline worst pain (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0668
72467274|NCT00551135|144457993|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0334|TWO_SIDED|||||Unadjusted (raw) p-value.|ANOVA|||LS (least squares) means from ANOVA model with terms of treatment, pooled center and baseline worst pain (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0334
72467275|NCT00551135|144457993|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8003|TWO_SIDED|||||Hochberg's adjustment applied to p-value; Hochberg's adjusted p-value was the primary analysis.|ANOVA|||LS Means from ANOVA model with terms of treatment, pooled center and baseline worst pain (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.8003
72467276|NCT00551135|144457993|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8003|TWO_SIDED|||||Unadjusted (raw) p-value.|ANOVA|||LS Means from ANOVA model with terms of treatment, pooled center and baseline worst pain (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.8003
72467277|NCT00551135|144457993|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6932|TWO_SIDED|||||Unadjusted (raw) p-value.|ANOVA|||LS Means from ANOVA model with terms of treatment, pooled center and baseline worst pain (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.6932
72467278|NCT00551135|144457994|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4471|TWO_SIDED||||||ANOVA|||Baseline; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from sitting (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.4471
72467279|NCT00551135|144457994|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7248|TWO_SIDED||||||ANOVA|||Baseline; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from sitting (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.7248
72503684|NCT02975349|144538470|SUPERIORITY||Hodges-Lehmann estimate|0.0||||0.9731|TWO_SIDED|95.0|-0.25|0.25|||Wilcoxon rank-sum test|||||0.25|-0.25|0.9731
72503685|NCT02975349|144538470|SUPERIORITY||Hodges-Lehmann estimate|-0.25||||0.0017|TWO_SIDED|95.0|-0.5|0.0|||Wilcoxon rank-sum test|||||0.00|-0.50|0.0017
72503686|NCT02975349|144538470|SUPERIORITY||Hodges-Lehmann estimate|-0.5|||<|0.0001|TWO_SIDED|95.0|-0.75|-0.25|||Wilcoxon rank-sum test|||||-0.25|-0.75|< 0.0001
72503687|NCT02975349|144538471|SUPERIORITY||Lesion Rate ratio|1.29||||0.4807|TWO_SIDED|95.0|0.63|2.65|||Negative Binomial|||||2.65|0.63|0.4807
72503688|NCT02975349|144538471|SUPERIORITY||Lesion Rate ratio|0.5||||0.062|TWO_SIDED|95.0|0.24|1.04|||Negative Binomial|||||1.04|0.24|0.0620
72503689|NCT02975349|144538471|SUPERIORITY||Lesion Rate ratio|0.42||||0.0189|TWO_SIDED|95.0|0.2|0.87|||Negative Binomial|||||0.87|0.20|0.0189
72503690|NCT02975349|144538472|SUPERIORITY||Difference in least squares means|0.02||||0.8776|TWO_SIDED|95.0|-0.24|0.28|||Mixed Effect Model for Repeat Measures||Difference in least squares means of change from baseline in cube root of volume measured in centimeter.|||0.28|-0.24|0.8776
72503691|NCT02975349|144538472|SUPERIORITY||Difference in least squares means|-0.41||||0.0019|TWO_SIDED|95.0|-0.66|-0.15|||Mixed Effect Model for Repeat Measures||Difference in least squares means of change from baseline in cube root of volume measured in centimeter.|||-0.15|-0.66|0.0019
72503692|NCT02975349|144538472|SUPERIORITY||Difference in least squares means|-0.36||||0.0063|TWO_SIDED|95.0|-0.62|-0.1|||Mixed Effect Model for Repeat Measures||Difference in least squares means of change from baseline in cube root of volume measured in centimeter.|||-0.10|-0.62|0.0063
72503693|NCT02975349|144538473|SUPERIORITY||Hodges-Lehmann estimate|0.0||||0.9315|TWO_SIDED|95.0|-0.004|0.009|||Wilcoxon rank-sum test|||||0.009|-0.004|0.9315
72503694|NCT02975349|144538473|SUPERIORITY||Hodges-Lehmann estimate|-0.014||||0.0008|TWO_SIDED|95.0|-0.05|0.0|||Wilcoxon rank-sum test|||||0.000|-0.050|0.0008
72503695|NCT02975349|144538473|SUPERIORITY||Hodges-Lehmann estimate|-0.018||||0.0014|TWO_SIDED|95.0|-0.042|0.0|||Wilcoxon rank-sum test|||||0.000|-0.042|0.0014
72503696|NCT03167619|144538526|SUPERIORITY||MLE assuming exponential distribution|0.18||||0.0023|TWO_SIDED|95.0|0.11|0.27|||Chi-squared|Comparison to mean of historical control|Presence of patients with long PFS may have violated exponential assumption.|Assumed median PFS = 2.0 months as historical control, transformed to rate of 0.35/month||0.27|0.11|0.0023
72503697|NCT03167619|144538527|SUPERIORITY||MLE assuming exponential distribution|0.11|||<|0.0001|TWO_SIDED|95.0|0.07|0.19|||Chi-squared|Comparison to mean of historical control|Presence of patients with long PFS may have violated exponential assumption.|Assumed median PFS = 2.0 months as historical control, transformed to rate of 0.35/month||0.19|0.07|<0.0001
72503698|NCT02082184|144538548|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.03|STANDARD_ERROR_OF_MEAN|0.114||0.8222|TWO_SIDED||||||ANCOVA|||||||0.8222
72503699|NCT02082184|144538549|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|0.58||0.7925|TWO_SIDED||||||ANCOVA|||||||0.7925
72503700|NCT02082184|144538550|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.47|STANDARD_ERROR_OF_MEAN|0.134|<|0.001|TWO_SIDED||||||ANCOVA|||Statistical analysis of time spent \<70 mg/dL||||<0.001
72503701|NCT02082184|144538550|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.22|STANDARD_ERROR_OF_MEAN|0.068||0.0014|TWO_SIDED||||||ANCOVA|||Statistical analysis of time spent \<55 mg/dL||||0.0014
72503702|NCT02082184|144538551|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.16|STANDARD_ERROR_OF_MEAN|0.065||0.0164|TWO_SIDED||||||ANCOVA|||Statistical analysis of frequency of episodes \<70 mg/dL||||0.0164
72503703|NCT02082184|144538551|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.12|STANDARD_ERROR_OF_MEAN|0.037||0.0017|TWO_SIDED||||||ANCOVA|||Statistical analysis of frequency of episodes \<55 mg/dL||||0.0017
72503704|NCT02082184|144538552|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3|STANDARD_ERROR_OF_MEAN|0.63||0.597|TWO_SIDED||||||ANCOVA|||Statistical analysis of time spent \>180 mg/dL||||0.5970
72503705|NCT02082184|144538552|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.46||0.8729|TWO_SIDED||||||ANCOVA|||Statistical analysis of time spent \>240 mg/dL||||0.8729
72503706|NCT02082184|144538555|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.31||0.6075|TWO_SIDED||||||ANCOVA|||Perceived frequency of hyperglycaemia||||0.6075
72503707|NCT02082184|144538555|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.26||0.2295|TWO_SIDED||||||ANCOVA|||Perceived frequency of hypoglycaemia||||0.2295
72503708|NCT02082184|144538555|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.1|STANDARD_ERROR_OF_MEAN|0.8|<|0.001|TWO_SIDED||||||ANCOVA|||Total treatment satisfaction score||||<0.001
72503709|NCT01466751|144538559|SUPERIORITY_OR_OTHER||Type III Tests of Fixed Effects|8.687||||0.004|TWO_SIDED|||||A-priori threshold for statistical significance: p \< 0.05. No correction for multiple comparisons. The omnibus effect from the linear mixed model for the Treatment Arm x Time Interaction was utilized to establish significance of the effect.|Mixed Models Analysis|Numerator degrees of freedom=1, Denominator degrees of freedom = 168||A linear mixed model was utilized to test the null hypothesis that the intervention groups would show equivalent performance change on the outcome measure from baseline to the 3 month time points.||||0.004
72503710|NCT01466751|144538560|SUPERIORITY_OR_OTHER||Type III Tests of Fixed Effects|2.032||||0.156|TWO_SIDED|||||No adjustment for multiple comparisons. The a priori threshold was: p \< 0.05.|Mixed Models Analysis|Numerator degrees of freedom: 1, Denominator degrees of freedom: 168||A linear mixed model was used to test the null hypothesis that the two treatment groups would display no differential changes in amygdala BOLD signal from baseline to 3 months as a main effect or in interaction with facial affect type (fear or happy) or by brain hemisphere (left or right).||||0.156
72503711|NCT02413398|144538565|SUPERIORITY||Mean Difference (Final Values)|-0.34|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.53|-0.15|||Mixed Models Analysis|||Difference in adjusted mean change from baseline (MMRM model)||-0.15|-0.53|<0.001
72503712|NCT02413398|144538566|SUPERIORITY||Mean Difference (Final Values)|-1.43|STANDARD_ERROR_OF_MEAN|0.37|<|0.001|TWO_SIDED|95.0|-2.15|-0.69|||Mixed Models Analysis|||Difference in adjusted mean percent change from baseline (MMRM)||-0.69|-2.15|<0.001
72503713|NCT02413398|144538567|SUPERIORITY||Mean Difference (Final Values)|-16.59|STANDARD_ERROR_OF_MEAN|5.15||0.001|TWO_SIDED|95.0|-26.73|-6.45|||Mixed Models Analysis|||Difference in adjusted mean change from baseline versus placebo (MMRM)||-6.45|-26.73|0.001
72503714|NCT02413398|144538568|SUPERIORITY||Mean Difference (Final Values)|-3.1|STANDARD_ERROR_OF_MEAN|1.6|<|0.05|TWO_SIDED|95.0|-6.3|0.0|||Mixed Models Analysis|||Difference in adjusted mean change from baseline vs. placebo (MMRM)||0.0|-6.3|<0.050
72503715|NCT02874794|144538589|SUPERIORITY||Median Difference (Final Values)|-2.2||||0.7827|TWO_SIDED|95.0|-17.6|13.2|||ANCOVA|||||13.2|-17.6|0.7827
72503716|NCT02874794|144538592|SUPERIORITY||Ratio of Geometric Means|0.6667|||<|0.0001|TWO_SIDED|95.0|0.5858|0.7589|||ANCOVA|||||0.7589|0.5858|<.0001
72503717|NCT02874794|144538593|SUPERIORITY||Mean Difference (Final Values)|-0.13||||0.5792|TWO_SIDED|95.0|-0.58|0.33|||ANCOVA|||||0.33|-0.58|0.5792
72503718|NCT02874794|144538594|SUPERIORITY||Mean Difference (Final Values)|-2.8|||<|0.0001|TWO_SIDED|95.0|-4.02|-1.59|||ANCOVA|||||-1.59|-4.02|<.0001
72621796|NCT00581100|144773963|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value from generalized linear models for correlated data using Generalized Estimating Equations (GEE) with treatment and visits as fixed factors. Model for proportion=\[Group visit Group\*visit\].|GEE model|||Week 24||||<0.001
72467280|NCT00551135|144457994|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7556|TWO_SIDED||||||ANOVA|||Baseline; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from sitting (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.7556
72467281|NCT00551135|144457994|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0571|TWO_SIDED||||||ANOVA|||2 h BS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from sitting (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0571
72503719|NCT02874794|144538595|SUPERIORITY||Median Difference (Final Values)|-0.03||||0.8617|TWO_SIDED|95.0|-0.33|0.27|||ANCOVA|||||0.27|-0.33|0.8617
72621797|NCT00581100|144773963|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value from generalized linear models for correlated data using Generalized Estimating Equations (GEE) with treatment and visits as fixed factors. Model for proportion=\[Group visit Group\*visit\].|GEE model|||Week 24||||<0.001
72467282|NCT00551135|144457994|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0197|TWO_SIDED||||||ANOVA|||2 h BS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from sitting (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0197
72467283|NCT00551135|144457994|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2398|TWO_SIDED||||||ANOVA|||2 h BS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from sitting (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.2398
72467284|NCT00551135|144457994|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0709|TWO_SIDED||||||ANOVA|||1 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from sitting (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0709
72467285|NCT00551135|144457994|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9902|TWO_SIDED||||||ANOVA|||1 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from sitting (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.9902
72467286|NCT00551135|144457994|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0018|TWO_SIDED||||||ANOVA|||1 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from sitting (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0018
72467287|NCT00551135|144457994|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4639|TWO_SIDED||||||ANOVA|||2 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from sitting (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.4639
72467288|NCT00551135|144457994|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4845|TWO_SIDED||||||ANOVA|||2 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from sitting (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.4845
72467289|NCT00551135|144457994|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1641|TWO_SIDED||||||ANOVA|||2 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from sitting (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.1641
72467290|NCT00551135|144457994|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1025|TWO_SIDED||||||ANOVA|||3 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from sitting (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.1025
72467291|NCT00551135|144457994|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5615|TWO_SIDED||||||ANOVA|||3 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from sitting (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.5615
72467292|NCT00551135|144457994|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2904|TWO_SIDED||||||ANOVA|||3 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from sitting (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.2904
72467293|NCT00551135|144457994|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6017|TWO_SIDED||||||ANOVA|||Day 2 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from sitting (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.6017
72467294|NCT00551135|144457994|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8549|TWO_SIDED||||||ANOVA|||Day 2 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from sitting (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.8549
72467295|NCT00551135|144457994|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3386|TWO_SIDED||||||ANOVA|||Day 2 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from sitting (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.3386
72503720|NCT02874794|144538596|SUPERIORITY||Median Difference (Final Values)|-1.75||||0.0007|TWO_SIDED|95.0|-2.76|-0.75|||ANCOVA|||vs Enalapril||-0.75|-2.76|0.0007
72621798|NCT00581100|144773964|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value from generalized linear models for correlated data using Generalized Estimating Equations (GEE), with treatment and visits as fixed factors. Model for proportion =\[Group visit Group\*visit\].|GEE model|||Week 12||||<0.001
72467296|NCT00551135|144457994|SUPERIORITY_OR_OTHER_LEGACY|||||||0.707|TWO_SIDED||||||ANOVA|||Day 3 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from sitting (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.7070
72467297|NCT00551135|144457994|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5244|TWO_SIDED||||||ANOVA|||Day 3 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from sitting (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.5244
72467298|NCT00551135|144457994|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4245|TWO_SIDED||||||ANOVA|||Day 3 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from sitting (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.4245
72467299|NCT00551135|144457994|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8624|TWO_SIDED||||||ANOVA|||Day 4 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from sitting (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.8624
72467300|NCT00551135|144457994|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7552|TWO_SIDED||||||ANOVA|||Day 4 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from sitting (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.7552
72467301|NCT00551135|144457994|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7329|TWO_SIDED||||||ANOVA|||Day 4 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from sitting (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.7329
72467302|NCT00551135|144457994|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3053|TWO_SIDED||||||ANOVA|||Day 5 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from sitting (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.3053
72467303|NCT00551135|144457994|SUPERIORITY_OR_OTHER_LEGACY|||||||0.529|TWO_SIDED||||||ANOVA|||Day 5 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from sitting (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.5290
72467304|NCT00551135|144457994|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7951|TWO_SIDED||||||ANOVA|||Day 5 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from sitting (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.7951
72467305|NCT00551135|144457994|SUPERIORITY_OR_OTHER_LEGACY|||||||0.715|TWO_SIDED||||||ANOVA|||Day 6 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from sitting (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.7150
72467306|NCT00551135|144457994|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4566|TWO_SIDED||||||ANOVA|||Day 6 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from sitting (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.4566
72467307|NCT00551135|144457994|SUPERIORITY_OR_OTHER_LEGACY|||||||0.775|TWO_SIDED||||||ANOVA|||Day 6 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from sitting (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.7750
72467308|NCT00551135|144457994|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9241|TWO_SIDED||||||ANOVA|||Day 7 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from sitting (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.9241
72467309|NCT00551135|144457994|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8994|TWO_SIDED||||||ANOVA|||Day 7 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from sitting (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.8994
72467310|NCT00551135|144457994|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2088|TWO_SIDED||||||ANOVA|||Day 7 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from sitting (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.2088
72503721|NCT02874794|144538597|SUPERIORITY||Median Difference (Final Values)|0.63||||0.2354|TWO_SIDED|95.0|-0.41|1.68|||ANCOVA|||||1.68|-0.41|0.2354
72503722|NCT02874794|144538598|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.8215|TWO_SIDED|95.0|-0.05|0.04|||ANCOVA|||||0.04|-0.05|0.8215
72503723|NCT02874794|144538599|SUPERIORITY||Median Difference (Final Values)|-1.58||||0.0452|TWO_SIDED|95.0|-3.13|-0.03|||ANCOVA|||||-0.03|-3.13|0.0452
72503724|NCT02874794|144538600|SUPERIORITY||Mean Difference (Final Values)|-1.97||||0.0242|TWO_SIDED|95.0|-3.68|-0.26|||ANCOVA|||||-0.26|-3.68|0.0242
72503725|NCT00537940|144538601|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|0.0||||0.8708|TWO_SIDED|95.0|-6.0|7.0|||Ranked ANCOVA|||Rank analysis of covariance (ANCOVA) model was used to derive p-value with treatment as main effect and cluster as cofactor, percent change in 28-day seizure counts between Baseline and treatment periods as dependent variable. Median differences and 95% confidence interval (CI) were based on Hodges-Lehmann estimation.||7.0|-6.0|0.8708
72503726|NCT00537940|144538602|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.92||||0.662|TWO_SIDED|95.0|0.635|1.335|||Regression, Logistic|||The odds ratio and its 95% CI are calculated by exponentiating the log odds ratio and 95% CI that correspond to the treatment contrast in the logistic regression model with treatment as fixed effect and Baseline term and country as covariate. All statistical tests for secondary efficacy parameters were two sided and performed at significance level of α = 0.05. The above statistical analysis applies to All Partial Seizures - FAS Population.||1.335|0.635|0.662
72467311|NCT00551135|144457994|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2152|TWO_SIDED||||||ANOVA|||EOT; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from sitting (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.2152
72503727|NCT00537940|144538603|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9232|TWO_SIDED|||||All partial seizure: p-value was calculated from the 2-sided Fisher's exact test.|Fisher Exact|||||||0.9232
72503728|NCT00537940|144538603|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6361|TWO_SIDED|||||Simple Partial: p-value was calculated from the 2-sided Fisher's exact test.|Fisher Exact|||||||0.6361
72503729|NCT00537940|144538603|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9075|TWO_SIDED|||||Complex partial: p-value was calculated from the 2-sided Fisher's exact test.|Fisher Exact|||||||0.9075
72503730|NCT00537940|144538603|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4203|TWO_SIDED|||||SGTC seizure: p-value was calculated from the 2-sided Fisher's exact test.|Fisher Exact|||||||0.4203
72503731|NCT00537940|144538604|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5069|TWO_SIDED|||||All partial seizure: p-value was calculated from the 2-sided Fisher's exact test.|Fisher Exact|||||||0.5069
72503732|NCT00537940|144538604|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4721|TWO_SIDED|||||Simple partial seizure: p-value was calculated from the 2-sided Fisher's exact test.|Fisher Exact|||||||0.4721
72503733|NCT00537940|144538604|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6054|TWO_SIDED|||||Complex partial seizure: p-value was calculated from the 2-sided Fisher's exact test.|Fisher Exact|||||||0.6054
72503734|NCT00537940|144538604|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6603|TWO_SIDED|||||SGTC seizure: p-value was calculated from the 2-sided Fisher's exact test.|Fisher Exact|||||||0.6603
72503735|NCT00537940|144538606|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1881|TWO_SIDED|||||p-value is calculated using Fisher Exact Test.|Fisher Exact|||||||0.1881
72503736|NCT00537940|144538607|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference (Final Values)|0.22|STANDARD_ERROR_OF_MEAN|0.38||0.5643|TWO_SIDED|95.0|-0.53|0.97|||ANCOVA|||Baseline, HADS-A: ANCOVA model was used to calculate least square (LS) mean estimates of the treatment difference along with 95% CI, with main effects of treatment and and country as covariates.||0.97|-0.53|0.5643
72503737|NCT00537940|144538607|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference (Final Values)|0.09|STANDARD_ERROR_OF_MEAN|0.32||0.7712|TWO_SIDED|95.0|-0.73|0.54|||ANCOVA|||Change at Week 21 / ET , HADS-A: ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and country as covariates.||0.54|-0.73|0.7712
72503738|NCT00537940|144538607|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference (Final Values)|0.28|STANDARD_ERROR_OF_MEAN|0.35||0.4236|TWO_SIDED|95.0|-0.41|0.97|||Ranked ANCOVA|||Baseline, HADS-D: ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and combined center, and for post-baseline assessments baseline was included as a covariate.||0.97|-0.41|0.4236
72564733|NCT01682148|144660986|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Based on a π of 63% in the reference group, a clinically relevant Δ of 17%, α=2.5% (one sided) and power=80%, the sample size estimate yielded 122 valid subjects per group. Including a 10% addition for premature withdrawals, 136 subjects per group were necessary to be randomised in the study (i.e., a total of 272 subjects).|Treatment difference|-0.1673||||0.9167|TWO_SIDED|95.0|-0.363|0.0284||Based on a generalised linear model including factors for MAS at Baseline.|Generalised linear model||Difference of the two clinical success rates (NMJ Targeted minus Current Clinical Practice).|A responder was defined as a subject with at least one level decrease on the MAS scale.||0.0284|-0.3630|0.9167
72564734|NCT01682148|144660986|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Based on a π of 63% in the reference group, a clinically relevant Δ of 17%, α=2.5% (one sided) and power=80%, the sample size estimate yielded 122 valid subjects per group. Including a 10% addition for premature withdrawals, 136 subjects per group were necessary to be randomised in the study (i.e., a total of 272 subjects).|Treatment difference|0.0707||||0.6052|TWO_SIDED|95.0|-0.1948|0.3362||Based on a generalised linear model including factors for treatment.|Generalised linear model||Difference of the two clinical success rates (NMJ Targeted minus Current Clinical Practice).|A responder was defined as a subject with at least one level decrease on the MAS scale.||0.3362|-0.1948|0.6052
72564735|NCT01682148|144660986|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Based on a π of 63% in the reference group, a clinically relevant Δ of 17%, α=2.5% (one sided) and power=80%, the sample size estimate yielded 122 valid subjects per group. Including a 10% addition for premature withdrawals, 136 subjects per group were necessary to be randomised in the study (i.e., a total of 272 subjects).|Treatment difference|0.0707||||0.5369|TWO_SIDED|95.0|-0.1948|0.3362||Based on a generalised linear model including factors for spasticity pattern.|Generalised linear model||Difference of the two clinical success rates (NMJ Targeted minus Current Clinical Practice).|A responder was defined as a subject with at least one level decrease on the MAS scale.||0.3362|-0.1948|0.5369
72621799|NCT00581100|144773964|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value from generalized linear models for correlated data using Generalized Estimating Equations (GEE), with treatment and visits as fixed factors. Model for proportion =\[Group visit Group\*visit\].|GEE model|||Week 12||||<0.001
72370719|NCT00488683|144251643|SUPERIORITY_OR_OTHER||R-square|0.01||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and rise in serogroup specific IgG concentration after booster vaccination age for the serogroup C||||
72503739|NCT00537940|144538607|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference (Final Values)|-0.17|STANDARD_ERROR_OF_MEAN|0.29||0.5492|TWO_SIDED|95.0|-0.75|0.4|||Ranked ANCOVA|||Change at Week 21/ET, HADS-D: ANCOVA model was used to calculate LS mean estimates of the treatment1difference along with 95% CI, with main effects of treatment and combined center, and for post-baseline assessments baseline was included as a covariate.||0.40|-0.75|0.5492
72503740|NCT00537940|144538608|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference (Final Values)|3.25|STANDARD_ERROR_OF_MEAN|2.07||0.116|TWO_SIDED|95.0|-0.81|7.31|||ANCOVA|||Baseline Sleep disturbance: ANCOVA model was used to calculate least square (LS) mean estimates of the treatment difference along with 95% CI, with main effects of treatment and country; for post-baseline, baseline was included as a covariate.||7.31|-0.81|0.1160
72503741|NCT00537940|144538608|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference (Final Values)|-0.32|STANDARD_ERROR_OF_MEAN|1.68||0.849|TWO_SIDED|95.0|-3.62|2.98|||ANCOVA|||Week 21 Sleep disturbance: ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and country; for post-baseline, baseline was included as a covariate.||2.98|-3.62|0.8490
72503742|NCT00537940|144538608|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference (Final Values)|1.19|STANDARD_ERROR_OF_MEAN|2.82||0.6728|TWO_SIDED|95.0|-4.34|6.73|||ANCOVA|||Baseline snoring: ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and country; for post-baseline, baseline was included as a covariate.||6.73|-4.34|0.6728
72394575|NCT02310568|144295792|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.58|||||TWO_SIDED|90.0|0.16|2.09|||Regression, Logistic|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Stage 2: Logistic regression model included treatment as fixed effect, and the baseline as covariate. Baseline for Stage 1 is Day 1 and for Stage 2 is Day 28.||2.09|0.16|
72467312|NCT00551135|144457994|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7662|TWO_SIDED||||||ANOVA|||EOT; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from sitting (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.7662
72467313|NCT00551135|144457994|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7579|TWO_SIDED||||||ANOVA|||EOT; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from sitting (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.7579
72467314|NCT00551135|144457995|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6896|TWO_SIDED||||||ANOVA|||Baseline; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from walking (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.6896
72467315|NCT00551135|144457995|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1934|TWO_SIDED||||||ANOVA|||Baseline; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from walking (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.1934
72467316|NCT00551135|144457995|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6034|TWO_SIDED||||||ANOVA|||Baseline; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from walking (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.6034
72467317|NCT00551135|144457995|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7992|TWO_SIDED||||||ANOVA|||2 h BS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from walking (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.7992
72394576|NCT02310568|144295793|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.21||0.801|TWO_SIDED|90.0|-0.4|0.3|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - Placebo). Week 1: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||0.3|-0.4|0.801
72467318|NCT00551135|144457995|SUPERIORITY_OR_OTHER_LEGACY|||||||0.477|TWO_SIDED||||||ANOVA|||2 h BS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from walking (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.4770
72467319|NCT00551135|144457995|SUPERIORITY_OR_OTHER_LEGACY|||||||0.873|TWO_SIDED||||||ANOVA|||2 h BS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from walking (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.8730
72467320|NCT00551135|144457995|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2|TWO_SIDED||||||ANOVA|||1 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from walking (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.2000
72467321|NCT00551135|144457995|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5059|TWO_SIDED||||||ANOVA|||1 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from walking (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.5059
72467322|NCT00551135|144457995|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0348|TWO_SIDED||||||ANOVA|||1 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from walking (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0348
72503743|NCT00537940|144538608|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference (Final Values)|1.96|STANDARD_ERROR_OF_MEAN|2.3||0.3954|TWO_SIDED|95.0|-2.56|6.47|||ANCOVA|||Week 21 snoring: ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and country; for post-baseline, baseline was included as a covariate.||6.47|-2.56|0.3954
72621800|NCT00581100|144773964|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value from generalized linear models for correlated data using Generalized Estimating Equations (GEE), with treatment and visits as fixed factors. Model for proportion =\[Group visit Group\*visit\].|GEE model|||Week 24||||<0.001
72467323|NCT00551135|144457995|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3815|TWO_SIDED||||||ANOVA|||2 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from walking (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.3815
72467324|NCT00551135|144457995|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4716|TWO_SIDED||||||ANOVA|||2 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from walking (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.4716
72467325|NCT00551135|144457995|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1063|TWO_SIDED||||||ANOVA|||2 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from walking (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.1063
72467326|NCT00551135|144457995|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3884|TWO_SIDED||||||ANOVA|||3 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from walking (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.3884
72503744|NCT00537940|144538608|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference (Final Values)|4.03|STANDARD_ERROR_OF_MEAN|2.52||0.1106|TWO_SIDED|95.0|-0.92|8.98|||ANCOVA|||Baseline Awaken Short of Breath: ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and country; for post-baseline, baseline was included as a covariate.||8.98|-0.92|0.1106
72467327|NCT00551135|144457995|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3787|TWO_SIDED||||||ANOVA|||3 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from walking (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.3787
72467328|NCT00551135|144457995|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2537|TWO_SIDED||||||ANOVA|||3 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from walking (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.2537
72503745|NCT00537940|144538608|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference (Final Values)|-1.93|STANDARD_ERROR_OF_MEAN|2.11||0.3603|TWO_SIDED|95.0|-6.09|2.22|||ANCOVA|||Week 21 Awaken Short of Breath: ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and country; for post-baseline, baseline was included as a covariate.||2.22|-6.09|0.3603
72503746|NCT00537940|144538608|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference (Final Values)|-0.03|STANDARD_ERROR_OF_MEAN|0.14||0.8312|TWO_SIDED|95.0|-0.3|0.24|||ANCOVA|||Baseline Quantity of Sleep: ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and country; for post-baseline, baseline was included as a covariate.||0.24|-0.30|0.8312
72503747|NCT00537940|144538608|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.2||0.9101|TWO_SIDED|95.0|-0.38|0.42|||ANCOVA|||Week 21 Quantity of Sleep: ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and country; for post-baseline, baseline was included as a covariate.||0.42|-0.38|0.9101
72503748|NCT00537940|144538608|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference (Final Values)|-2.37|STANDARD_ERROR_OF_MEAN|2.45||0.3346|TWO_SIDED|95.0|-7.19|2.45|||ANCOVA|||Baseline Adequacy of Sleep: ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and country; for post-baseline, baseline was included as a covariate.||2.45|-7.19|0.3346
72503749|NCT00537940|144538608|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference (Final Values)|-0.66|STANDARD_ERROR_OF_MEAN|2.05||0.7491|TWO_SIDED|95.0|-4.69|3.37|||ANCOVA|||Week 21 Adequacy of Sleep: ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and country; for post-baseline, baseline was included as a covariate.||3.37|-4.69|0.7491
72503750|NCT00537940|144538608|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference (Final Values)|2.98|STANDARD_ERROR_OF_MEAN|1.9||0.1162|TWO_SIDED|95.0|-0.74|6.71|||ANCOVA|||Baseline Somnolence: ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and country; for post-baseline, baseline was included as a covariate.||6.71|-0.74|0.1162
72503751|NCT00537940|144538608|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference (Final Values)|2.06|STANDARD_ERROR_OF_MEAN|1.66||0.2163|TWO_SIDED|95.0|-1.21|5.32|||ANCOVA|||Week 21 Somnolence: ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and country; for post-baseline, baseline was included as a covariate.||5.32|-1.21|0.2163
72503752|NCT00537940|144538608|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference (Final Values)|3.45|STANDARD_ERROR_OF_MEAN|1.61||0.0321|TWO_SIDED|95.0|0.3|6.61|||ANCOVA|||Baseline Sleep Problem Index (9): ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and country; for post-baseline, baseline was included as a covariate.||6.61|0.30|0.0321
72503753|NCT00537940|144538608|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference (Final Values)|0.34|STANDARD_ERROR_OF_MEAN|1.28||0.7889|TWO_SIDED|95.0|-2.17|2.85|||ANCOVA|||Week 21 Sleep Problem Index (9): ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and country; for post-baseline, baseline was included as a covariate.||2.85|-2.17|0.7889
72503754|NCT00537940|144538609|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.653||||0.0252|TWO_SIDED|95.0|0.449|0.948|||Regression, Logistic|||Baseline: Logistic regression model was used to estimate odds ratio and corresponding 95% CI of treatment difference, with treatment as fixed effect and for post-baseline assessments baseline was included as a covariate.||0.948|0.449|0.0252
72503755|NCT00537940|144538609|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.811||||0.3459|TWO_SIDED|95.0|0.524|1.254|||Regression, Logistic|||Week 21: Logistic regression model was used to estimate odds ratio and corresponding 95% CI of treatment difference, with treatment as fixed effect and for post-baseline assessments baseline was included as a covariate.||1.254|0.524|0.3459
72467329|NCT00551135|144457995|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0952|TWO_SIDED||||||ANOVA|||Day 2 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from walking (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0952
72467330|NCT00551135|144457995|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7725|TWO_SIDED||||||ANOVA|||Day 2 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from walking (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.7725
72467331|NCT00551135|144457995|SUPERIORITY_OR_OTHER_LEGACY|||||||0.066|TWO_SIDED||||||ANOVA|||Day 2 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from walking (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0660
72503756|NCT01062399|144538610|OTHER||||||||||||||||||A dose level for RAD001 will be considered acceptable if no patient of the first 3patients or no more than 2 patients of the first 6 patients experience a DLT. If the current level is considered acceptable, then dose escalation will occur and the protocol will be reopened. Otherwise, the preceding acceptable dose level will be declared the MTD.|||
72504847|NCT01894516|144540613|SUPERIORITY||Difference in percentage rates|37.5|||<|0.0001|TWO_SIDED|95.0|22.4|52.6||P-value has been corrected for multiplicity according to Hommel's closed-testing method.|Regression, Logistic|||Pairwise comparisons of each group vs. the placebo group using a logistic regression model with factors treatment group, geographical region, and prior use of biologics.||52.6|22.4|< 0.0001
72504848|NCT01894516|144540613|SUPERIORITY||Difference in percentage rates|36.5|||<|0.0001|TWO_SIDED|95.0|21.3|51.8||P-value has been corrected for multiplicity according to Hommel's closed-testing method.|Regression, Logistic|||Pairwise comparisons of each group vs. the placebo group using a logistic regression model with factors treatment group, geographical region, and prior use of biologics.||51.8|21.3|< 0.0001
72467332|NCT00551135|144457995|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3657|TWO_SIDED||||||ANOVA|||Day 3 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from walking (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.3657
72467333|NCT00551135|144457995|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7717|TWO_SIDED||||||ANOVA|||Day 3 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from walking (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.7717
72467334|NCT00551135|144457995|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5849|TWO_SIDED||||||ANOVA|||Day 3 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from walking (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.5849
72503757|NCT01062399|144538611|SUPERIORITY||Hazard Ratio (HR)|1.15||||0.79|TWO_SIDED|95.0|0.82|1.6|||Log Rank||Reference arm = RT + TMZ|Assuming exponential distribution with median PFS (mPFS) time for control of 6.7 mos. for the control arm, tt was hypothesized that there would be a 43% improvement in mPFS time, corresponding to a mPFS time of 9.6. This is equivalent to a hazard ratio of 0.7 for the experimental arm vs. control arm. With a 1-sided significance level = 0.15 and 85% power, a total of 134 PFS events out of 180 eligible patients were required to detect the projected effect size.||1.60|0.82|0.79
72503758|NCT01062399|144538612|SUPERIORITY||Hazard Ratio (HR)|1.67||||0.008|TWO_SIDED|95.0|1.14|2.45|||Log Rank|2-sided significance level = 0.05|Reference level = RT + TMZ|||2.45|1.14|0.008
72503759|NCT00634543|144538618|NON_INFERIORITY_OR_EQUIVALENCE|Non inferiority was demonstrated if lower confidence limit of 2-sided 95% CI was less than the non-inferiority margin of 1.39.|Mean Difference (Net)|0.39||||0.2143|TWO_SIDED|95.0|-0.23|1.01|||t-test, 2 sided|P-value was calculated for change from baseline in pain intensity score at Day 43.||||1.01|-0.23|0.2143
72503760|NCT00634543|144538619|SUPERIORITY_OR_OTHER|||||||0.7539|||||||Chi-squared|P-value was evaluated for pain relief in tramadol hydrochloride/ acetaminophen versus gabapentin groups at Day 15.||||||0.7539
72503761|NCT00634543|144538619|SUPERIORITY_OR_OTHER|||||||0.5905|||||||Chi-squared|P-value was evaluated for pain relief in tramadol hydrochloride/ acetaminophen versus gabapentin groups at Day 29.||||||0.5905
72503762|NCT00634543|144538619|SUPERIORITY_OR_OTHER|||||||0.7407|||||||Chi-squared|P-value was evaluated for pain relief in tramadol hydrochloride/ acetaminophen versus gabapentin groups at Day 43.||||||0.7407
72503763|NCT00634543|144538620|SUPERIORITY_OR_OTHER|||||||0.3504|||||||Chi-squared|P-value was evaluated for all categories (bad, no change, good and very good).||||||0.3504
72503764|NCT00634543|144538621|SUPERIORITY_OR_OTHER|||||||0.569|||||||Chi-squared|P-value was evaluated for all categories (bad, no change, good and very good).||||||0.5690
72564736|NCT01682148|144660986|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Based on a π of 63% in the reference group, a clinically relevant Δ of 17%, α=2.5% (one sided) and power=80%, the sample size estimate yielded 122 valid subjects per group. Including a 10% addition for premature withdrawals, 136 subjects per group were necessary to be randomised in the study (i.e., a total of 272 subjects).|Treatment difference|0.0707||||0.7732|TWO_SIDED|95.0|-0.1948|0.3362||Based on a generalised linear model including factors for country.|Generalised linear model||Difference of the two clinical success rates (NMJ Targeted minus Current Clinical Practice).|A responder was defined as a subject with at least one level decrease on the MAS scale.||0.3362|-0.1948|0.7732
72564737|NCT01682148|144660986|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Based on a π of 63% in the reference group, a clinically relevant Δ of 17%, α=2.5% (one sided) and power=80%, the sample size estimate yielded 122 valid subjects per group. Including a 10% addition for premature withdrawals, 136 subjects per group were necessary to be randomised in the study (i.e., a total of 272 subjects).|Treatment difference|0.0707||||0.1758|TWO_SIDED|95.0|-0.1948|0.3362||Based on a generalised linear model including factors for MAS at Baseline.|Generalised linear model||Difference of the two clinical success rates (NMJ Targeted minus Current Clinical Practice).|A responder was defined as a subject with at least one level decrease on the MAS scale.||0.3362|-0.1948|0.1758
72467335|NCT00551135|144457995|SUPERIORITY_OR_OTHER_LEGACY|||||||0.958|TWO_SIDED||||||ANOVA|||Day 4 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from walking (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.9580
72467336|NCT00551135|144457995|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9884|TWO_SIDED||||||ANOVA|||Day 4 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from walking (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.9884
72467337|NCT00551135|144457995|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6743|TWO_SIDED||||||ANOVA|||Day 4 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from walking (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.6743
72467338|NCT00551135|144457995|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2689|TWO_SIDED||||||ANOVA|||Day 5 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from walking (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.2689
72467339|NCT00551135|144457995|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6907|TWO_SIDED||||||ANOVA|||Day 5 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from walking (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.6907
72503765|NCT05299892|144538636|OTHER||Mean Difference (Final Values)|6.46153||||0.005|TWO_SIDED|95.0|1.79|12.99|||ANOVA|||An ANOVA was conducted for the three SE conditions (off, moderate, strong) at 50 dBA .Post -hoc comparisons were done using Bonferroni's correction. Below result is the mean comparison between SE of and SE moderate. Analysis of age effects was not completed.||12.99|1.79|.005
72503766|NCT05299892|144538636|OTHER||Mean Difference (Final Values)|9.00961|||<|0.001|TWO_SIDED|95.0|3.91|15.11|||ANOVA|||An ANOVA was conducted for the three SE conditions (off, moderate, strong) at 50 dBA . Post -hoc comparisons were done using Bonferroni's correction. Below result is the mean comparison between SE of and SE strong. An analysis of age effects was not completed.||15.11|3.91|<.001
72503767|NCT05299892|144538636|OTHER||||||<|0.001|||||||t-test, 2 sided|||Null hypothesis: There will be no significant differences between the mean unaided CNC score at 50 dBA and the mean aided CNC score with SE off.||||<0.001
72503768|NCT05483127|144538663|NON_INFERIORITY|Noninferiority in distance VA was declared if upper confidence limit was less than 0.05.|Least squares mean difference|-0.01|STANDARD_ERROR_OF_MEAN|0.003|||ONE_SIDED|95.0||0.0||Since a noninferiority hypothesis is being tested, a p-value is not applicable. Confidence limit is being reported and compared to the noninferiority margin.|||LSM results based on mixed effects repeated measures model with both fixed (lens, visit, lens by visit interaction, period, sequence) and random (subject) effects. Difference=P1fA - MDT. Sign (negative or positive) is retained with the rounded value.|||-0.00||
72503769|NCT00258154|144538696|NON_INFERIORITY_OR_EQUIVALENCE|non-inferiority criterion is that the lower limit of the 2-sided 95% confidence interval of the proportion difference (Rotateq+INFANRIX hexa group minus Placebo+INFANRIX hexa group) for subjects who achieve serum antibody levels of ≥ 10 mIU/mL greater than -10%|Percentage point difference|0.0|||<|0.001||95.0|-3.7|3.6|||Miettinen and Nurminen's|Comparing percentage difference with the non-inferiority margin of 10 percentage point with Miettinen and Nurminen's method|Percentage point difference (RotaTeq - Placebo)|||3.6|-3.7|<0.001
72564738|NCT01682148|144660988|SUPERIORITY_OR_OTHER_LEGACY||Treatment difference|-0.1324||||0.24|TWO_SIDED|95.0|-0.3531|0.0884||Based on a generalised linear model including factors for treatment, spasticity pattern, country and MAS baseline score.|Generalised linear model||Difference of the two clinical success rates (NMJ Targeted minus Current Clinical Practice).|A responder was defined as a subject with at least one level decrease on the MAS scale.||0.0884|-0.3531|0.2400
72467340|NCT00551135|144457995|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4798|TWO_SIDED||||||ANOVA|||Day 5 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from walking (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.4798
72467341|NCT00551135|144457995|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5609|TWO_SIDED||||||ANOVA|||Day 6 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from walking (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.5609
72467342|NCT00551135|144457995|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9834|TWO_SIDED||||||ANOVA|||Day 6 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from walking (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.9834
72467343|NCT00551135|144457995|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8339|TWO_SIDED||||||ANOVA|||Day 6 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from walking (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.8339
72503770|NCT00258154|144538698|NON_INFERIORITY_OR_EQUIVALENCE|non-inferiority criterion is that the lower limit of the 2-sided 95% confidence interval of the proportion difference (Rotateq+INFANRIX hexa group minus Placebo+INFANRIX hexa group) for subjects who achieve serum antibody levels of ≥ 0.15 μg/mL greater than -10%.|Percentage point difference|-3.7||||0.015||95.0|-9.3|1.3|||Miettinen and Nurminen's|Comparing percentage difference with the non-inferiority margin of 10 percentage point with Miettinen and Nurminen's method|Percentage point difference (RotaTeq - Placebo)|||1.3|-9.3|0.015
72564739|NCT01682148|144660989|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9448|TWO_SIDED|95.0|||||ANOVA|Analysis of variance (ANOVA) included factors for treatment, spasticity pattern and country, and Baseline VAS as a covariate.||Mean change in VAS from Baseline to Week 4.||||0.9448
72564740|NCT01682148|144660989|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5458|||||||ANOVA|ANOVA included factors for treatment, spasticity pattern and country, and Baseline VAS as a covariate.||Mean change in VAS from Baseline to Week 12.||||0.5458
72564741|NCT01682148|144660990|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4006|||||||ANOVA|ANOVA included factors for treatment, spasticity pattern and country.||||||0.4006
72467344|NCT00551135|144457995|SUPERIORITY_OR_OTHER_LEGACY|||||||0.873|TWO_SIDED||||||ANOVA|||Day 7 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from walking (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.8730
72467345|NCT00551135|144457995|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6327|TWO_SIDED||||||ANOVA|||Day 7 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from walking (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.6327
72467346|NCT00551135|144457995|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3986|TWO_SIDED||||||ANOVA|||Day 7 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from walking (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.3986
72564742|NCT01682148|144660991|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5747|||||||Mann-Whitney U-test|||||||0.5747
72564743|NCT01682148|144660992|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1802|||||||Mann-Whitney U-test|||||||0.1802
72467347|NCT00551135|144457995|SUPERIORITY_OR_OTHER_LEGACY|||||||0.637|TWO_SIDED||||||ANOVA|||EOT; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from walking (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.6370
72467348|NCT00551135|144457995|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9869|TWO_SIDED||||||ANOVA|||EOT; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from walking (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.9869
72564744|NCT03827018|144660996|SUPERIORITY||Hazard Ratio (HR)|0.38||||0.0263|TWO_SIDED|95.0|0.15|0.92||Comparison of KPL-301 and placebo with respect to time to flare calculated by using a log-rank test stratified by randomization strata.|Log Rank||95% confidence interval was calculated based on a Cox proportional-hazards model with treatment as covariate and stratified by randomization strata.|||0.92|0.15|0.0263
72467349|NCT00551135|144457995|SUPERIORITY_OR_OTHER_LEGACY|||||||0.755|TWO_SIDED||||||ANOVA|||EOT; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from walking (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.7550
72394577|NCT02310568|144295793|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.2||0.416|TWO_SIDED|90.0|-0.5|0.2|||Mixed-Effects Model Repeated Measure|||(PF-06372865 2.5 mg - Placebo). Week 1: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||0.2|-0.5|0.416
72394578|NCT02310568|144295793|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.23||0.634|TWO_SIDED|90.0|-0.3|0.5|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 1: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||0.5|-0.3|0.634
72467350|NCT00551135|144457996|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2912|TWO_SIDED||||||ANOVA|||Baseline; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from coughing (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.2912
72503771|NCT00847613|144538728|SUPERIORITY_OR_OTHER_LEGACY||Percent difference|36.48|||<|0.0001|TWO_SIDED|95.0|27.73|45.23||A step-down procedure was used to control for multiple comparisons. In order for the comparison to 5 mg to be statistically significant, the comparison to 10 mg had to be statistically significant.|Normal approximation|||Normal approximation for the difference in binomial proportions was used to test the superiority of each dose of CP-690,550 to placebo.||45.23|27.73|<0.0001
72467351|NCT00551135|144457996|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3723|TWO_SIDED||||||ANOVA|||Baseline; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from coughing (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.3723
72467352|NCT00551135|144457996|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6116|TWO_SIDED||||||ANOVA|||Baseline; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from coughing (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.6116
72467353|NCT00551135|144457996|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0835|TWO_SIDED||||||ANOVA|||2 h BS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from coughing (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0835
72394579|NCT02310568|144295793|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.24||0.47|TWO_SIDED|90.0|-0.6|0.2|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - Placebo). Week 2: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||0.2|-0.6|0.470
72394580|NCT02310568|144295793|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.24||0.683|TWO_SIDED|90.0|-0.5|0.3|||Mixed-Effects Model Repeated Measure|||(PF-06372865 2.5 mg - Placebo). Week 2: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||0.3|-0.5|0.683
72467354|NCT00551135|144457996|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1497|TWO_SIDED||||||ANOVA|||2 h BS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from coughing (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.1497
72467355|NCT00551135|144457996|SUPERIORITY_OR_OTHER_LEGACY|||||||0.395|TWO_SIDED||||||ANOVA|||2 h BS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from coughing (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.3950
72467356|NCT00551135|144457996|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5892|TWO_SIDED||||||ANOVA|||1 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from coughing (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.5892
72467357|NCT00551135|144457996|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6143|TWO_SIDED||||||ANOVA|||1 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from coughing (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.6143
72467358|NCT00551135|144457996|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0104|TWO_SIDED||||||ANOVA|||1 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from coughing (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0104
72467359|NCT00551135|144457996|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5666|TWO_SIDED||||||ANOVA|||2 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from coughing (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.5666
72467360|NCT00551135|144457996|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9008|TWO_SIDED||||||ANOVA|||2 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from coughing (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.9008
72467361|NCT00551135|144457996|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0967|TWO_SIDED||||||ANOVA|||2 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from coughing (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0967
72467362|NCT00551135|144457996|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8353|TWO_SIDED||||||ANOVA|||3 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from coughing (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.8353
72503772|NCT00847613|144538728|SUPERIORITY_OR_OTHER_LEGACY||Percent difference|26.13|||<|0.0001|TWO_SIDED|95.0|17.28|34.97||A step-down procedure was used to control for multiple comparisons. In order for the comparison to 5 mg to be statistically significant, the comparison to 10 mg had to be statistically significant.|Normal approximation|||Normal approximation for the difference in binomial proportions was used to test the superiority of each dose of CP-690,550 to placebo.||34.97|17.28|<0.0001
72394581|NCT02310568|144295793|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.27||0.775|TWO_SIDED|90.0|-0.5|0.4|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 2: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||0.4|-0.5|0.775
72394582|NCT02310568|144295793|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.24||0.848|TWO_SIDED|90.0|-0.4|0.3|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - Placebo). Week 3: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||0.3|-0.4|0.848
72394583|NCT02310568|144295793|SUPERIORITY_OR_OTHER||LS Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|0.23||0.49|TWO_SIDED|90.0|-0.2|0.6|||Mixed-Effects Model Repeated Measure|||(PF-06372865 2.5 mg - Placebo). Week 3: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||0.6|-0.2|0.490
72467363|NCT00551135|144457996|SUPERIORITY_OR_OTHER_LEGACY|||||||0.453|TWO_SIDED||||||ANOVA|||3 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from coughing (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.4530
72467364|NCT00551135|144457996|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7297|TWO_SIDED||||||ANOVA|||3 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from coughing (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.7297
72467365|NCT00551135|144457996|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0692|TWO_SIDED||||||ANOVA|||Day 2 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from coughing (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0692
72467366|NCT00551135|144457996|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6333|TWO_SIDED||||||ANOVA|||Day 2 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from coughing (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.6333
72394584|NCT02310568|144295793|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.27||0.433|TWO_SIDED|90.0|-0.7|0.2|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 3: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||0.2|-0.7|0.433
72467367|NCT00551135|144457996|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0325|TWO_SIDED||||||ANOVA|||Day 2 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from coughing (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0325
72467368|NCT00551135|144457996|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5788|TWO_SIDED||||||ANOVA|||Day 3 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from coughing (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.5788
72467369|NCT00551135|144457996|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9224|TWO_SIDED||||||ANOVA|||Day 3 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from coughing (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.9224
72467370|NCT00551135|144457996|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5527|TWO_SIDED||||||ANOVA|||Day 3 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from coughing (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.5527
72467371|NCT00551135|144457996|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2624|TWO_SIDED||||||ANOVA|||Day 4 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from coughing (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.2624
72467372|NCT00551135|144457996|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3263|TWO_SIDED||||||ANOVA|||Day 4 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from coughing (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.3263
72467373|NCT00551135|144457996|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3746|TWO_SIDED||||||ANOVA|||Day 4 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from coughing (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.3746
72467374|NCT00551135|144457996|SUPERIORITY_OR_OTHER_LEGACY|||||||0.005|TWO_SIDED||||||ANOVA|||Day 5 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from coughing (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0050
72467375|NCT00551135|144457996|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0493|TWO_SIDED||||||ANOVA|||Day 5 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from coughing (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0493
72467376|NCT00551135|144457996|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0773|TWO_SIDED||||||ANOVA|||Day 5 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from coughing (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0773
72467377|NCT00551135|144457996|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0547|TWO_SIDED||||||ANOVA|||Day 6 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from coughing (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0547
72467378|NCT00551135|144457996|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1976|TWO_SIDED||||||ANOVA|||Day 6 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from coughing (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.1976
72467379|NCT00551135|144457996|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3832|TWO_SIDED||||||ANOVA|||Day 6 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from coughing (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.3832
72467380|NCT00551135|144457996|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4216|TWO_SIDED||||||ANOVA|||Day 7 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from coughing (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.4216
72503773|NCT00847613|144538729|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.19||0.0376|TWO_SIDED|95.0|-0.79|-0.02||A step-down procedure was used to control for multiple comparisons. For comparison of 10 mg to placebo to be statistically significant in this measure, comparison of 10 mg to placebo in ACR20 had to be significant.|Mixed Models Analysis|||Change at Month 6: Linear mixed model with treatment effect and site location as fixed effects and baseline value as covariate was used for the analysis.||-0.02|-0.79|0.0376
72503774|NCT00847613|144538729|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.34|STANDARD_ERROR_OF_MEAN|0.2||0.0792|TWO_SIDED|95.0|-0.73|0.04||A step-down procedure was used to control for multiple comparisons. For comparison of 5 mg to placebo to be statistically significant, comparison of 10 mg to placebo and comparison of 5 mg to placebo in ACR20 had to be statistically significant.|Mixed Models Analysis|||Change at Month 6: Linear mixed model with treatment effect and site location as fixed effects and baseline value as covariate was used for the analysis.||0.04|-0.73|0.0792
72503775|NCT00847613|144538730|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.05|<|0.0001|TWO_SIDED|95.0|-0.49|-0.31||A step-down procedure was used to control for multiple comparisons. For comparison of 10 mg to placebo to be statistically significant in this measure, comparison of 10 mg to placebo in mTSS had to be significant.|Mixed Models Analysis|||Change at Month 3: Least squares mean difference and corresponding 95% confidence interval (CI) was calculated using a mixed-effect repeated measure model with treatment, visit and treatment-by-visit interaction as fixed effect and participant as random effect.||-0.31|-0.49|<0.0001
72503776|NCT00847613|144538730|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.25|STANDARD_ERROR_OF_MEAN|0.05||0.0002|TWO_SIDED|95.0|-0.34|-0.16||A step-down procedure was used to control for multiple comparisons. For comparison of 5 mg to placebo to be statistically significant, comparison of 10 mg to placebo and comparison of 5 mg to placebo in mTSS had to be statistically significant.|Mixed Models Analysis|||Change at Month 3: Least squares mean difference and corresponding 95% CI was calculated using a mixed-effect repeated measure model with treatment, visit and treatment-by-visit interaction as fixed effect and participant as random effect.||-0.16|-0.34|0.0002
72503777|NCT00847613|144538731|SUPERIORITY_OR_OTHER_LEGACY||Percent difference|14.4|||<|0.0001|TWO_SIDED|95.0|9.44|19.36||A step-down procedure was used to control for multiple comparisons. For comparison of 10 mg to placebo to be statistically significant in this measure, comparison of 10 mg to placebo in HAQ-DI had to be significant.|Normal approximation|||Normal approximation to the binomial distribution was used to test the superiority of CP-690,550 10 mg to placebo and two-sided 95% CI was evaluated for the difference in percentages.||19.36|9.44|<0.0001
72503778|NCT00847613|144538731|SUPERIORITY_OR_OTHER_LEGACY||Percent difference|5.61||||0.0034|TWO_SIDED|95.0|1.85|9.38||A step-down procedure was used to control for multiple comparisons. For comparison of 5 mg to placebo to be statistically significant, comparison of 10 mg to placebo and comparison of 5 mg to placebo in HAQ-DI had to be statistically significant.|Normal approximation|||Normal approximation to the binomial distribution was used to test the superiority of CP-690,550 10 mg to placebo and two-sided 95% CI was evaluated for the difference in percentages.||9.38|1.85|0.0034
72621801|NCT00581100|144773964|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value from generalized linear models for correlated data using Generalized Estimating Equations (GEE), with treatment and visits as fixed factors. Model for proportion =\[Group visit Group\*visit\].|GEE model|||Week 24||||<0.001
72621802|NCT00581100|144773965|SUPERIORITY_OR_OTHER|||||||0.069||95.0||||P-value from generalized linear models for correlated data using Generalized Estimating Equations (GEE) with treatment and visits as fixed factors. Model for proportion=\[Group visit Group\*visit\].|GEE model|||Week 12||||0.069
72467381|NCT00551135|144457996|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5852|TWO_SIDED||||||ANOVA|||Day 7 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from coughing (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.5852
72467382|NCT00551135|144457996|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7336|TWO_SIDED||||||ANOVA|||Day 7 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from coughing (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.7336
72467383|NCT00551135|144457996|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1647|TWO_SIDED||||||ANOVA|||EOT; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from coughing (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.1647
72467384|NCT00551135|144457996|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2813|TWO_SIDED||||||ANOVA|||EOT; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from coughing (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.2813
72467385|NCT00551135|144457996|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8423|TWO_SIDED||||||ANOVA|||EOT; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from coughing (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.8423
72621803|NCT00581100|144773965|SUPERIORITY_OR_OTHER|||||||0.006||95.0||||P-value from generalized linear models for correlated data using Generalized Estimating Equations (GEE) with treatment and visits as fixed factors. Model for proportion=\[Group visit Group\*visit\].|GEE model|||Week 12||||0.006
72467386|NCT00551135|144457997|SUPERIORITY_OR_OTHER_LEGACY|||||||0.397|TWO_SIDED||||||ANOVA|||"Sitting; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain caused by sitting. Centers with fewer than 8 treated subjects were combined into pooled centers.~Last observation carried forward algorithm or first non-missing observation carried backward algorithm applied to missing scores 1-3 h PS and independently to missing scores 24-48 h PS, before applying trapezoidal rule to compute AUC. AUC=missing if all scores 1-3 or 24-48 h PS missing."||||0.3970
72467387|NCT00551135|144457997|SUPERIORITY_OR_OTHER_LEGACY|||||||0.764|TWO_SIDED||||||ANOVA|||"Sitting; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain caused by sitting. Centers with fewer than 8 treated subjects were combined into pooled centers.~Last observation carried forward algorithm or first non-missing observation carried backward algorithm applied to missing scores 1-3 h PS and independently to missing scores 24-48 h PS, before applying trapezoidal rule to compute AUC. AUC=missing if all scores 1-3 or 24-48 h PS missing."||||0.7640
72467388|NCT00551135|144457997|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5064|TWO_SIDED||||||ANOVA|||"Sitting; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain caused by sitting. Centers with fewer than 8 treated subjects were combined into pooled centers.~Last observation carried forward algorithm or first non-missing observation carried backward algorithm applied to missing scores 1-3 h PS and independently to missing scores 24-48 h PS, before applying trapezoidal rule to compute AUC. AUC=missing if all scores 1-3 or 24-48 h PS missing."||||0.5064
72467389|NCT00551135|144457997|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1318|TWO_SIDED||||||ANOVA|||"Walking; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain caused by walking. Centers with fewer than 8 treated subjects were combined into pooled centers.~Last observation carried forward algorithm or first non-missing observation carried backward algorithm applied to missing scores 1-3 h PS and independently to missing scores 24-48 h PS, before applying trapezoidal rule to compute AUC. AUC=missing if all scores 1-3 or 24-48 h PS missing."||||0.1318
72467390|NCT00551135|144457997|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9367|TWO_SIDED||||||ANOVA|||"Walking; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain caused by walking. Centers with fewer than 8 treated subjects were combined into pooled centers.~Last observation carried forward algorithm or first non-missing observation carried backward algorithm applied to missing scores 1-3 h PS and independently to missing scores 24-48 h PS, before applying trapezoidal rule to compute AUC. AUC=missing if all scores 1-3 or 24-48 h PS missing."||||0.9367
72503779|NCT00754390|144538794|SUPERIORITY_OR_OTHER|||||||0.17||95.0|||||Mixed Models Analysis|||Two-way mixed model analysis of variance was used to test for main effect of dietary calcium and phytate and their interaction. Null Hypothesis: Dietary calcium does not affect zinc absorption||||0.17
72503780|NCT00754390|144538794|SUPERIORITY_OR_OTHER|||||||0.0002||95.0|||||Mixed Models Analysis|||Two-way mixed model analysis of variance was used to test for main effect of dietary calcium and phytate and their interaction. Null Hypothesis: Dietary Phytate does not affect zinc absorption||||0.0002
72503781|NCT00754390|144538794|SUPERIORITY_OR_OTHER|||||||0.09||95.0|||||Mixed Models Analysis|||Two-way mixed model analysis of variance was used to test for main effect of dietary calcium and phytate and their interaction. Null Hypothesis: Dietary calcium and dietary phytate do not affect zinc absorption. Eight women were required to detect a difference in zinc absorption of 7 percentage points with a power of 90%, alpha level of 0.05.||||0.09
72503782|NCT00624338|144538847|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.16||||0.518|TWO_SIDED|95.0|0.74|1.82||Odds ratios were calculated from a logistic regression model adjusted for race and disease severity reported at screening.|Regression, Logistic|||||1.82|0.74|0.518
72621804|NCT00581100|144773965|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value from generalized linear models for correlated data using Generalized Estimating Equations (GEE) with treatment and visits as fixed factors. Model for proportion=\[Group visit Group\*visit\].|GEE model|||Week 24||||<0.001
72467391|NCT00551135|144457997|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1259|TWO_SIDED||||||ANOVA|||"Walking; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain caused by walking. Centers with fewer than 8 treated subjects were combined into pooled centers.~Last observation carried forward algorithm or first non-missing observation carried backward algorithm applied to missing scores 1-3 h PS and independently to missing scores 24-48 h PS, before applying trapezoidal rule to compute AUC. AUC=missing if all scores 1-3 or 24-48 h PS missing."||||0.1259
72467392|NCT00551135|144457997|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1812|TWO_SIDED||||||ANOVA|||"Coughing; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain caused by coughing. Centers with fewer than 8 treated subjects were combined into pooled centers.~Last observation carried forward algorithm or first non-missing observation carried backward algorithm applied to missing scores 1-3 h PS and independently to missing scores 24-48 h PS, before applying trapezoidal rule to compute AUC. AUC=missing if all scores 1-3 or 24-48 h PS missing."||||0.1812
72467393|NCT00551135|144457997|SUPERIORITY_OR_OTHER_LEGACY|||||||0.96|TWO_SIDED||||||ANOVA|||"Coughing; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain caused by coughing. Centers with fewer than 8 treated subjects were combined into pooled centers.~Last observation carried forward algorithm or first non-missing observation carried backward algorithm applied to missing scores 1-3 h PS and independently to missing scores 24-48 h PS, before applying trapezoidal rule to compute AUC. AUC=missing if all scores 1-3 or 24-48 h PS missing."||||0.9600
72467394|NCT00551135|144457997|SUPERIORITY_OR_OTHER_LEGACY|||||||0.105|TWO_SIDED||||||ANOVA|||"Coughing; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain caused by coughing. Centers with fewer than 8 treated subjects were combined into pooled centers.~Last observation carried forward algorithm or first non-missing observation carried backward algorithm applied to missing scores 1-3 h PS and independently to missing scores 24-48 h PS, before applying trapezoidal rule to compute AUC. AUC=missing if all scores 1-3 or 24-48 h PS missing."||||0.1050
72503783|NCT00624338|144538847|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.49||||0.003|TWO_SIDED|95.0|0.31|0.78||Odds ratios were calculated from a logistic regression model adjusted for race and disease severity reported at screening.|Regression, Logistic|Atacicept 150 mg arm was discontinued prematurely. The analysis of 150 mg was considered post-hoc.||||0.78|0.31|0.003
72503784|NCT00624338|144538848|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.984||||0.929|TWO_SIDED|95.0|0.69|1.4||Cox proportional hazards model was performed to calculate hazard ratios and adjusted for race and disease severity at time of screening.|Regression, Cox|||||1.40|0.69|0.929
72394585|NCT02310568|144295793|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.25||0.796|TWO_SIDED|90.0|-0.4|0.5|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - Placebo). Week 4: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||0.5|-0.4|0.796
72621805|NCT00581100|144773965|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value from generalized linear models for correlated data using Generalized Estimating Equations (GEE) with treatment and visits as fixed factors. Model for proportion=\[Group visit Group\*visit\].|GEE model|||Week 24||||<0.001
72621806|NCT00581100|144773966|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Adjusted change calculated from mixed model. Model for change=\[Group visit group\*visit baseline baseline\*visit\].|Mixed Models Analysis|||||||<0.0001
72394586|NCT02310568|144295793|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.25||0.624|TWO_SIDED|90.0|-0.3|0.5|||Mixed-Effects Model Repeated Measure|||(PF-06372865 2.5 mg - Placebo). Week 4: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||0.5|-0.3|0.624
72467395|NCT00551135|144457998|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2818|TWO_SIDED||||||ANOVA|||2 h BS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.2818
72467396|NCT00551135|144457998|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8631|TWO_SIDED||||||ANOVA|||2 h BS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.8631
72503785|NCT00624338|144538848|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.562||||0.009|TWO_SIDED|95.0|0.36|0.87||Cox proportional hazards model was performed to calculate hazard ratios and adjusted for race and disease severity at time of screening.|Regression, Cox|Atacicept 150 mg arm was discontinued prematurely. The analysis of 150 mg was considered post-hoc.||||0.87|0.36|0.009
72621807|NCT00581100|144773966|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Adjusted change calculated from mixed model. Model for change=\[Group visit group\*visit baseline baseline\*visit\].|Mixed Models Analysis|||||||<0.0001
72467397|NCT00551135|144457998|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5074|TWO_SIDED||||||ANOVA|||2 h BS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.5074
72467398|NCT00551135|144457998|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0401|TWO_SIDED||||||ANOVA|||1 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0401
72467399|NCT00551135|144457998|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5509|TWO_SIDED||||||ANOVA|||1 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.5509
72467400|NCT00551135|144457998|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0004|TWO_SIDED||||||ANOVA|||1 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0004
72467401|NCT00551135|144457998|SUPERIORITY_OR_OTHER_LEGACY|||||||0.707|TWO_SIDED||||||ANOVA|||2 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.7070
72467402|NCT00551135|144457998|SUPERIORITY_OR_OTHER_LEGACY|||||||0.384|TWO_SIDED||||||ANOVA|||2 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.3840
72467403|NCT00551135|144457998|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2732|TWO_SIDED||||||ANOVA|||2 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.2732
72503786|NCT00624338|144538849|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.215||||0.412|TWO_SIDED|95.0|0.76|1.94||Odds ratios were calculated from a logistic regression model, adjusted for race and disease severity reported at screening.|Regression, Logistic|||||1.94|0.76|0.412
72503787|NCT00624338|144538849|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.722||||0.198|TWO_SIDED|95.0|0.44|1.19||Odds ratios were calculated from a logistic regression model, adjusted for race and disease severity reported at screening.|Regression, Logistic|Atacicept 150 mg arm was discontinued prematurely. The analysis of 150 mg was considered post-hoc.||||1.19|0.44|0.198
72503788|NCT00144300|144538889|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.07||||||95.0|0.71|1.6||||||||1.60|0.71|
72503789|NCT01933672|144538910|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-31.24|||||TWO_SIDED|80.0|-36.35|-26.12||||||Change from baseline||-26.12|-36.35|
72503790|NCT01933672|144538910|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-31.33|||||TWO_SIDED|80.0|-37.29|-25.37||||||Change from baseline||-25.37|-37.29|
72503791|NCT01933672|144538910|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.24|||||TWO_SIDED|80.0|-24.99|-13.5||||||Change from baseline||-13.50|-24.99|
72503792|NCT01933672|144538910|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.99|||||TWO_SIDED|80.0|-19.81|-4.17||||||There was no hypothesis to be tested. Difference in change from baseline in WMDG between the 2 treatment groups was calculated based on the mixed effects repeated measures model.||-4.17|-19.81|
72503793|NCT01933672|144538910|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.09|||||TWO_SIDED|80.0|-19.81|-4.17||||||There was no hypothesis to be tested. Difference in change from baseline in WMDG between the 2 treatment groups was calculated based on the mixed effects repeated measures model.||-4.17|-19.81|
72503794|NCT01933672|144538911|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-21.92|||||TWO_SIDED|80.0|-27.0|-16.85||||||Compared with Baseline||-16.85|-27.00|
72503795|NCT01933672|144538911|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-20.7|||||TWO_SIDED|80.0|-26.3|-15.1||||||Compared with Baseline||-15.10|-26.30|
72503796|NCT01933672|144538911|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.51|||||TWO_SIDED|80.0|-22.24|-10.78||||||Compared with Baseline||-10.78|-22.24|
72621808|NCT00581100|144773967|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value from generalized linear models for correlated data using Generalized Estimating Equations (GEE) with treatment and visits as fixed factors. Model for proportion=\[Group visit Group\*visit\].|GEE model|||Week 12||||<0.001
72467404|NCT00551135|144457998|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4418|TWO_SIDED||||||ANOVA|||3 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.4418
72467405|NCT00551135|144457998|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8379|TWO_SIDED||||||ANOVA|||3 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.8379
72467406|NCT00551135|144457998|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5944|TWO_SIDED||||||ANOVA|||3 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.5944
72467407|NCT00551135|144457998|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8139|TWO_SIDED||||||ANOVA|||Day 2 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.8139
72467408|NCT00551135|144457998|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9709|TWO_SIDED||||||ANOVA|||Day 2 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.9709
72467409|NCT00551135|144457998|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9666|TWO_SIDED||||||ANOVA|||Day 2 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.9666
72467410|NCT00551135|144457998|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3204|TWO_SIDED||||||ANOVA|||Day 3 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.3204
72467411|NCT00551135|144457998|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0869|TWO_SIDED||||||ANOVA|||Day 3 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0869
72467412|NCT00551135|144457998|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9386|TWO_SIDED||||||ANOVA|||Day 3 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.9386
72467413|NCT00551135|144457998|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4352|TWO_SIDED||||||ANOVA|||Day 4 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.4352
72467414|NCT00551135|144457998|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4522|TWO_SIDED||||||ANOVA|||Day 4 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.4522
72467415|NCT00551135|144457998|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6606|TWO_SIDED||||||ANOVA|||Day 4 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.6606
72467416|NCT00551135|144457998|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1733|TWO_SIDED||||||ANOVA|||Day 5 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.1733
72467417|NCT00551135|144457998|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8788|TWO_SIDED||||||ANOVA|||Day 5 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.8788
72467418|NCT00551135|144457998|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8474|TWO_SIDED||||||ANOVA|||Day 5 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.8474
72467419|NCT00551135|144457998|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2938|TWO_SIDED||||||ANOVA|||Day 6 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.2938
72503797|NCT01933672|144538911|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-5.41|||||TWO_SIDED|80.0|-11.74|0.92||||||Change from baseline in FPG was analyzed in a mixed model analysis of covariance (ANCOVA) with regimen, period, sequence, treatment × period, and carryover as fixed effects. Subjects within sequences were modelled as random effects, with each subject's period-specific baseline response included, as fixed covariates.||0.92|-11.74|
72503798|NCT01933672|144538911|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.19|||||TWO_SIDED|80.0|-10.86|2.49||||||Change from baseline in FPG was analyzed in a mixed model analysis of covariance (ANCOVA) with regimen, period, sequence, treatment × period, and carryover as fixed effects. Subjects within sequences were modelled as random effects, with each subject's period-specific baseline response included, as fixed covariates.||2.49|-10.86|
72503799|NCT01933672|144538912|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.06|||||TWO_SIDED|80.0|-0.19|0.07||||||Compared with Baseline （Pre-breakfast）||0.07|-0.19|
72503800|NCT01933672|144538912|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.06|||||TWO_SIDED|80.0|-0.09|0.21||||||Compared with Baseline (Pre-breakfast)||0.21|-0.09|
72503801|NCT01933672|144538912|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3|||||TWO_SIDED|80.0|0.16|0.45||||||Compared with Baseline (Pre-breakfast)||0.45|0.16|
72503802|NCT01933672|144538912|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.36|||||TWO_SIDED|80.0|-0.56|-0.36||||||Pre-breakfast; Time-matched change from baseline in pre-meal C-peptide on Day 14 was analyzed using a mixed effects model with sequence, period, treatment, the treatment by-time interaction, period-specific baseline and carryover as fixed effects. Subjects within sequences were modeled as random effects.||-0.36|-0.56|
72503803|NCT01933672|144538912|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.24|||||TWO_SIDED|80.0|-0.45|-0.03||||||Pre-breakfast; Time-matched change from baseline in pre-meal C-peptide on Day 14 was analyzed using a mixed effects model with sequence, period, treatment, the treatment by-time interaction, period-specific baseline and carryover as fixed effects. Subjects within sequences were modeled as random effects.||-0.03|-0.45|
72503804|NCT01933672|144538912|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2|||||TWO_SIDED|80.0|-0.08|0.48||||||Compared with Baseline (Pre-lunch)||0.48|-0.08|
72503805|NCT01933672|144538912|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.7|||||TWO_SIDED|80.0|0.38|1.03||||||Compared with Baseline (Pre-lunch)||1.03|0.38|
72503806|NCT01933672|144538912|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.06|||||TWO_SIDED|80.0|-0.26|0.37||||||Compared with Baseline (Pre-lunch)||0.37|-0.26|
72503807|NCT01933672|144538912|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.14||||||80.0|-0.28|0.57||||||Pre-lunch; Time-matched change from baseline in pre-meal C-peptide on Day 14 was analyzed using a mixed effects model with sequence, period, treatment, the treatment by-time interaction, period-specific baseline and carryover as fixed effects. Subjects within sequences were modeled as random effects.||0.57|-0.28|
72503808|NCT01933672|144538912|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.65|||||TWO_SIDED|80.0|0.19|1.11||||||Pre-lunch; Time-matched change from baseline in pre-meal C-peptide on Day 14 was analyzed using a mixed effects model with sequence, period, treatment, the treatment by-time interaction, period-specific baseline and carryover as fixed effects. Subjects within sequences were modeled as random effects.||1.11|0.19|
72503809|NCT01933672|144538912|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.36|||||TWO_SIDED|80.0|0.03|0.68||||||Compared with Baseline (Pre-dinner)||0.68|0.03|
72503810|NCT01933672|144538912|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3|||||TWO_SIDED|80.0|-0.08|0.67||||||Compared with Baseline (Pre-dinner)||0.67|-0.08|
72503811|NCT01933672|144538912|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.32|||||TWO_SIDED|80.0|-0.05|0.68||||||Compared with Baseline (Pre-dinner)||0.68|-0.05|
72503812|NCT01933672|144538912|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.04|||||TWO_SIDED|80.0|-0.45|0.53||||||Pre-dinner; Time-matched change from baseline in pre-meal C-peptide on Day 14 was analyzed using a mixed effects model with sequence, period, treatment, the treatment by-time interaction, period-specific baseline and carryover as fixed effects. Subjects within sequences were modeled as random effects.||0.53|-0.45|
72503813|NCT01933672|144538912|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02|||||TWO_SIDED|80.0|-0.55|0.51||||||Pre-dinner; Time-matched change from baseline in pre-meal C-peptide on Day 14 was analyzed using a mixed effects model with sequence, period, treatment, the treatment by-time interaction, period-specific baseline and carryover as fixed effects. Subjects within sequences were modeled as random effects.||0.51|-0.55|
72503814|NCT01933672|144538913|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.16|||||TWO_SIDED|80.0|-0.75|1.07||||||Compared with Baseline （Pre-breakfast）||1.07|-0.75|
72503815|NCT01933672|144538913|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.46|||||TWO_SIDED|80.0|-0.58|1.51||||||Compared with Baseline (Pre-breakfast)||1.51|-0.58|
72503816|NCT01933672|144538913|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.6|||||TWO_SIDED|80.0|0.58|2.63||||||Compared with Baseline (Pre-breakfast)||2.63|0.58|
72503817|NCT01933672|144538913|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.45|||||TWO_SIDED|80.0|-2.84|-0.05||||||Pre-breakfast; Time-matched change from baseline in pre-meal insulin on Day 14 was analyzed using a mixed effects model with sequence, period, treatment, the treatment by-time interaction, period-specific baseline and carryover as fixed effects. Subjects within sequences were modeled as random effects.||-0.05|-2.84|
72503818|NCT01933672|144538913|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-1.14|||||TWO_SIDED|80.0|-2.63|0.35||||||Pre-breakfast; Time-matched change from baseline in pre-meal insulin on Day 14 was analyzed using a mixed effects model with sequence, period, treatment, the treatment by-time interaction, period-specific baseline and carryover as fixed effects. Subjects within sequences were modeled as random effects.||0.35|-2.63|
72503819|NCT01933672|144538913|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.69|||||TWO_SIDED|80.0|-0.5|3.88||||||Compared with Baseline (Pre-lunch)||3.88|-0.50|
72503820|NCT01933672|144538913|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.07|||||TWO_SIDED|80.0|1.56|6.58||||||Compared with Baseline (Pre-lunch)||6.58|1.56|
72503821|NCT01933672|144538913|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01|||||TWO_SIDED|80.0|-2.42|2.4||||||Compared with Baseline (Pre-lunch)||2.40|-2.42|
72503822|NCT01933672|144538913|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.7|||||TWO_SIDED|80.0|-1.62|5.01||||||Pre-lunch; Time-matched change from baseline in pre-meal insulin on Day 14 was analyzed using a mixed effects model with sequence, period, treatment, the treatment by-time interaction, period-specific baseline and carryover as fixed effects. Subjects within sequences were modeled as random effects.||5.01|-1.62|
72503823|NCT01933672|144538913|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.08|||||TWO_SIDED|80.0|0.54|7.62||||||Pre-lunch; Time-matched change from baseline in pre-meal insulin on Day 14 was analyzed using a mixed effects model with sequence, period, treatment, the treatment by-time interaction, period-specific baseline and carryover as fixed effects. Subjects within sequences were modeled as random effects.||7.62|0.54|
72503824|NCT01933672|144538913|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7|||||TWO_SIDED|80.0|-3.66|2.27||||||Compared with Baseline (Pre-dinner)||2.27|-3.66|
72503825|NCT01933672|144538913|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.06|||||TWO_SIDED|80.0|1.7|8.43||||||Compared with Baseline (Pre-dinner)||8.43|1.70|
72503826|NCT01933672|144538913|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.42|||||TWO_SIDED|80.0|-0.1|6.94||||||Compared with Baseline (Pre-dinner)||6.94|-0.10|
72503827|NCT01933672|144538913|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.12|||||TWO_SIDED|80.0|-8.42|0.18||||||Pre-dinner; Time-matched change from baseline in pre-meal insulin on Day 14 was analyzed using a mixed effects model with sequence, period, treatment, the treatment by-time interaction, period-specific baseline and carryover as fixed effects. Subjects within sequences were modeled as random effects.||0.18|-8.42|
72564745|NCT03827018|144660997|SUPERIORITY||Difference in proportions|33.3||||0.0038|TWO_SIDED|95.0|10.7|55.8||Two-sided p-value and 95% CI for the difference in sustained remission between two arms using normal approximation. Placebo arm is the reference.|normal approximation|||Secondary endpoints were analyzed in hierarchical order.||55.8|10.7|0.0038
72564746|NCT03827018|144660998|SUPERIORITY||Hazard Ratio (HR)|0.51||||0.0277|TWO_SIDED|95.0|0.27|0.95||Calculated by using a log-rank test stratified by randomization strata.|Log Rank||Calculated based on a Cox proportional-hazards model with treatment as covariate, and stratified by randomization strata.|Secondary endpoints were analyzed in hierarchical order.||0.95|0.27|0.0277
72621809|NCT00581100|144773967|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value from generalized linear models for correlated data using Generalized Estimating Equations (GEE) with treatment and visits as fixed factors. Model for proportion=\[Group visit Group\*visit\].|GEE model|||Week 12||||<0.001
72503828|NCT01933672|144538913|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.64|||||TWO_SIDED|80.0|-2.6|5.89||||||Pre-dinner; Time-matched change from baseline in pre-meal insulin on Day 14 was analyzed using a mixed effects model with sequence, period, treatment, the treatment by-time interaction, period-specific baseline and carryover as fixed effects. Subjects within sequences were modeled as random effects.||5.89|-2.60|
72503829|NCT01933672|144538916|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.8|||||TWO_SIDED|80.0|0.21|1.39||||||Compared with baseline||1.39|0.21|
72503830|NCT01933672|144538916|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.25|||||TWO_SIDED|80.0|-0.43|0.93||||||Compared with baseline||0.93|-0.43|
72503831|NCT01933672|144538916|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.26|||||TWO_SIDED|80.0|-0.92|0.4||||||Compared with baseline||0.40|-0.92|
72503832|NCT01933672|144538916|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.06|||||TWO_SIDED|80.0|0.17|1.95||||||||1.95|0.17|
72503833|NCT01933672|144538916|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.51|||||TWO_SIDED|80.0|-0.45|1.47||||||||1.47|-0.45|
72503834|NCT01225068|144538973|SUPERIORITY_OR_OTHER||effect size|0.22||||||||||no p value for effect size calculations ES is dimensionless; ES (Cohen's d) is a well described statistical construct and is calculated from the difference between the means (here at baseline and 6 weeks) divided by the pooled standard deviation.|effect size is endpoint and not comparis|no p value for effect size calculations||effect size is endpoint and not comparison||||
72503835|NCT02031146|144539007|OTHER|||||||0.29|||||||Two sample test of proportion in Stata|||||||0.29
72503836|NCT02031146|144539008|OTHER|||||||0.69|||||||Log Rank|||||||0.69
72503837|NCT02031146|144539009|OTHER|||||||0.04|||||||Log Rank|||||||0.04
72503838|NCT02839746|144539035|OTHER||||||<|0.0001|||||||non-parametric Wilcoxon signed-rank|||Within group comparison of Baseline convenience with that of Visit 2.||||<0.0001
72503839|NCT02839746|144539035|OTHER||||||<|0.0001|||||||non-parametric Wilcoxon signed-rank|||Within group comparison of Baseline satisfaction with that of Visit 2.||||<0.0001
72621810|NCT00581100|144773967|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value from generalized linear models for correlated data using Generalized Estimating Equations (GEE) with treatment and visits as fixed factors. Model for proportion=\[Group visit Group\*visit\].|GEE model|||Week 24||||<0.001
72621811|NCT00581100|144773967|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value from generalized linear models for correlated data using Generalized Estimating Equations (GEE) with treatment and visits as fixed factors. Model for proportion=\[Group visit Group\*visit\].|GEE model|||Week 24||||<0.001
72621812|NCT00581100|144773968|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value from generalized linear models for correlated data using Generalized Estimating Equations (GEE) with treatment and visits as fixed factors. Model for proportion=\[Group visit Group\*visit\].|GEE model|||Week 12||||<0.001
72503840|NCT02839746|144539036|OTHER||||||<|0.0001|||||||non-parametric Wilcoxon signed-rank|||Within group comparison of Baseline convenience with that of Visit 3.||||<0.0001
72503841|NCT02839746|144539036|OTHER|Within group comparison of Baseline satisfaction with that of Visit 3.|||||<|0.0001|||||||non-parametric Wilcoxon signed-rank]|||||||<0.0001
72503842|NCT02839746|144539037|OTHER||||||<|0.0001|||||||non-parametric Wilcoxon signed-rank|||Within group comparison of visit 2 convenience with that of Visit 3.||||<0.0001
72503843|NCT02839746|144539037|OTHER||||||<|0.0001|||||||non-parametric Wilcoxon signed-rank|||Within group comparison of visit 2 satisfaction with that of Visit 3.||||<0.0001
72503844|NCT02767570|144539046|SUPERIORITY||Mean Difference (Net)|-1.2||||0.001|TWO_SIDED|95.0|-1.9|-0.5||The threshold for statistical significance was p=0.05.|Regression, Linear||Difference = Altered FPA - Consistent FPA|For the primary hypothesis that there would be a greater reduction in pain for the altered compared to the consistent FPA group, an effect size of 0.57 was assumed. To achieve 80% power with an alpha of 0.05, 39 participants per group were needed, so our recruitment goal was 40 subjects per group.||-0.5|-1.9|0.001
72503845|NCT02767570|144539047|SUPERIORITY||Mean Difference (Net)|-0.26|||<|0.001|TWO_SIDED|95.0|-0.39|-0.13||The threshold for statistical significance was p=0.05.|Regression, Linear||Difference = Altered FPA - Consistent FPA|||-0.13|-0.39|<0.001
72503846|NCT02767570|144539048|SUPERIORITY||Mean Difference (Net)|-3.74||||0.006|TWO_SIDED|95.0|-6.42|-1.05||The threshold for statistical significance was p=0.05.|Regression, Linear||Difference = Altered FPA - Consistent FPA|||-1.05|-6.42|0.006
72503847|NCT02767570|144539049|SUPERIORITY||Mean Difference (Net)|-0.06||||0.93|TWO_SIDED|95.0|-1.42|1.3||The threshold for statistical significance was p=0.05.|Regression, Linear||Difference = Altered FPA - Consistent FPA|||1.30|-1.42|0.93
72503848|NCT02767570|144539050|SUPERIORITY||Mean Difference (Net)|-0.29||||0.85|TWO_SIDED|95.0|-3.38|2.8||The threshold for statistical significance was p=0.05.|Regression, Linear||Difference = Altered FPA - Consistent FPA|||2.80|-3.38|0.85
72503849|NCT02767570|144539051|SUPERIORITY||Mean Difference (Net)|0.0||||0.99|TWO_SIDED|95.0|-0.89|0.9||The threshold for statistical significance was p=0.05.|Regression, Linear||Difference = Altered FPA - Consistent FPA|||0.90|-0.89|0.99
72503850|NCT00151411|144539052|SUPERIORITY||Mean Difference (Final Values)|4.3||||0.54|TWO_SIDED|95.0|-9.9|18.4|||Mixed Models Analysis|||||18.4|-9.9|0.54
72503851|NCT00151411|144539053|SUPERIORITY||Rate Ratio|2.5||||0.07|TWO_SIDED|95.0|0.9|6.6|||Zero-altered negative binomial model||Placebo is the reference group, i.e. for the rate ratio, Metformin represents the numerator and Placebo the denominator.|This statistical analysis models the probability of ovulation.||6.6|0.9|0.07
72621813|NCT00581100|144773968|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value from generalized linear models for correlated data using Generalized Estimating Equations (GEE) with treatment and visits as fixed factors. Model for proportion=\[Group visit Group\*visit\].|GEE model|||Week 12||||<0.001
72621814|NCT00581100|144773968|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value from generalized linear models for correlated data using Generalized Estimating Equations (GEE) with treatment and visits as fixed factors. Model for proportion=\[Group visit Group\*visit\].|GEE model|||Week 24||||<0.001
72621815|NCT00581100|144773968|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value from generalized linear models for correlated data using Generalized Estimating Equations (GEE) with treatment and visits as fixed factors. Model for proportion=\[Group visit Group\*visit\].|GEE model|||Week 24||||<0.001
72503852|NCT00151411|144539053|SUPERIORITY||rate ratio|1.2||||0.51|TWO_SIDED|95.0|0.7|1.9|||Zero-altered negative binomial model||Placebo is the reference group, i.e. for the rate ratio, Metformin represents the numerator and Placebo the denominator.|This statistical analysis models the count of ovulations provided a woman actually ovulated.||1.9|0.7|0.51
72503853|NCT00151411|144539054|SUPERIORITY||Mean Difference (Final Values)|4.6||||0.05|TWO_SIDED|95.0|0.1|9.0|||Mixed Models Analysis|||||9.0|0.1|0.05
72503854|NCT04426630|144539060|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|Wilcoxon signed rank test||Heart failure patients in Uganda were enrolled in an mHealth program at the Uganda Heart Institute. The program intended to promote self-care for heart failure and improve patient healthcare quality of life.||||<0.001
72503855|NCT04426630|144539061|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|Wilcoxon signed rank test||||||<0.001
72503856|NCT04426630|144539062|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|Wilcoxon signed rank test||||||<0.001
72503857|NCT04426630|144539063|SUPERIORITY|||||||0.028|||||||Chi-squared|Wilcoxon sign-rank test used to compared baseline outcomes to 6 month outcomes.||Heart failure patients in Uganda were enrolled in an mHealth program at the Uganda Heart Institute. The program intended to promote self-care for heart failure and improve patient healthcare quality of life.||||0.028
72503858|NCT04426630|144539064|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
72503859|NCT04426630|144539065|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
72503860|NCT04426630|144539066|SUPERIORITY|||||||0.23|||||||Chi-squared|||||||0.23
72503861|NCT04426630|144539067|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
72503862|NCT04426630|144539068|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|Wilcoxon signed rank test||||||<0.001
72503863|NCT04426630|144539069|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|Wilcoxon signed rank test||||||<0.001
72503864|NCT04426630|144539070|SUPERIORITY|||||||0.07|||||||Wilcoxon (Mann-Whitney)|Wilcoxon signed rank test||||||0.07
72503865|NCT04426630|144539071|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
72503866|NCT01819935|144539072|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.93|||||TWO_SIDED|95.0|0.72|1.2||||||Propensity Cox proportional hazards regression model was used.||1.20|0.72|
72503867|NCT01819935|144539073|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.75|||||TWO_SIDED|95.0|0.53|1.05||||||Propensity Cox proportional hazards regression model was used.||1.05|0.53|
72503868|NCT01819935|144539074|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.02|||||TWO_SIDED|95.0|0.9|1.15||||||Propensity Cox proportional hazards regression model was used.||1.15|0.90|
72503869|NCT01819935|144539075|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.65|||||TWO_SIDED|95.0|0.39|1.09||||||Propensity Cox proportional hazards regression model was used.||1.09|0.39|
72503870|NCT01819935|144539076|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.96|||||TWO_SIDED|95.0|0.68|1.37||||||Propensity Cox proportional hazards regression model was used.||1.37|0.68|
72503871|NCT01819935|144539077|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.88|||||TWO_SIDED|95.0|0.68|1.13||||||Propensity Cox proportional hazards regression model was used.||1.13|0.68|
72503872|NCT01819935|144539078|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.89|||||TWO_SIDED|95.0|0.54|1.48||||||Propensity Cox proportional hazards regression model was used.||1.48|0.54|
72503873|NCT01819935|144539079|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.24|||||TWO_SIDED|95.0|1.06|1.45||||||Propensity Cox proportional hazards regression model was used.||1.45|1.06|
72503874|NCT01157169|144539080|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|110.49|||||TWO_SIDED|90.0|101.67|120.07|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||120.07|101.67|
72503875|NCT01157169|144539081|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|105.91|||||TWO_SIDED|90.0|99.74|112.45|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||112.45|99.74|
72504849|NCT01894516|144540613|SUPERIORITY||Difference in percentage rates|43.3|||<|0.0001|TWO_SIDED|95.0|28.4|58.2||P-value has been corrected for multiplicity according to Hommel's closed-testing method.|Regression, Logistic|||Pairwise comparisons of each group vs. the placebo group using a logistic regression model with factors treatment group, geographical region, and prior use of biologics.||58.2|28.4|< 0.0001
72504850|NCT03191396|144540629|NON_INFERIORITY|HbA1c non-inferiority was tested using a non-inferiority margin of 0.3.|Treatment difference|-0.69|||<|0.0001|TWO_SIDED|95.0|-0.82|-0.56||The non-inferiority p-value is calculated as two times the one-sided p-value from a t-distributed test statistic comparing the treatment contrast with 0.3.|ANCOVA||Semaglutide 1.0 mg - Liraglutide 1.2 mg|The responses are analysed using an ANCOVA with treatment and stratification factor as fixed factors and baseline value as covariate. Before analysis, missing data were multiple imputed using observed data from subjects within the same group defined by randomised treatment, using a regression model including stratification factor as categorical effect and data from baseline and all previous visits as covariates.||-0.56|-0.82|<0.0001
72504851|NCT03191396|144540629|SUPERIORITY||Treatment difference|-0.69|||<|0.0001|TWO_SIDED|95.0|-0.82|-0.56|||ANCOVA||Semaglutide 1.0 mg - Liraglutide 1.2 mg|||-0.56|-0.82|<0.0001
72504852|NCT03191396|144540630|SUPERIORITY||Treatment difference|-3.83|||<|0.0001|TWO_SIDED|95.0|-4.57|-3.09|||ANCOVA||Semaglutide 1.0 mg - Liraglutide 1.2 mg|||-3.09|-4.57|<0.0001
72504853|NCT01981122|144540710|SUPERIORITY|||||||0.095|||||||Mixed Models Analysis|Repeated Measures||||||.095
72504854|NCT01330381|144540711|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9002|||||||Cochran-Mantel-Haenszel|||||||0.9002
72504855|NCT01330381|144540712|SUPERIORITY_OR_OTHER_LEGACY|||||||0.352|||||||Cochran-Mantel-Haenszel|||||||0.3520
72504856|NCT01330381|144540713|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5228|||||||Cochran-Mantel-Haenszel|||||||0.5228
72503876|NCT01157169|144539082|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|103.97|||||TWO_SIDED|90.0|97.18|111.24|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||111.24|97.18|
72394587|NCT02310568|144295793|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.28||0.844|TWO_SIDED|90.0|-0.5|0.4|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 4: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||0.4|-0.5|0.844
72394588|NCT02310568|144295793|SUPERIORITY_OR_OTHER||LS Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|0.5||0.743|TWO_SIDED|90.0|-0.7|1.0|||LS Mean Difference|||(PF-06372865 7.5 mg - Placebo). Week 5: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||1.0|-0.7|0.743
72504857|NCT01330381|144540722|SUPERIORITY_OR_OTHER_LEGACY|||||||0.377|||||||Chi-squared|||||||0.377
72504858|NCT01330381|144540725|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1599|||||||Van Elteren test|||||||0.1599
72504859|NCT01330381|144540726|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0003|||||||Van Elteren test|||||||0.0003
72467420|NCT00551135|144457998|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7602|TWO_SIDED||||||ANOVA|||Day 6 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.7602
72467421|NCT00551135|144457998|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6881|TWO_SIDED||||||ANOVA|||Day 6 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.6881
72467422|NCT00551135|144457998|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7883|TWO_SIDED||||||ANOVA|||Day 7 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.7883
72467423|NCT00551135|144457998|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5374|TWO_SIDED||||||ANOVA|||Day 7 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.5374
72467424|NCT00551135|144457998|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9774|TWO_SIDED||||||ANOVA|||Day 7 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.9774
72504860|NCT01330381|144540727|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4647|||||||Van Elteren test|||||||0.4647
72504861|NCT01330381|144540728|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||Van Elteren test|||||||<0.0001
72504862|NCT01330381|144540729|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3044|||||||Van Elteren test|||||||0.3044
72504863|NCT02435173|144540746|SUPERIORITY||Adjusted means difference|-0.24|STANDARD_ERROR_OF_MEAN|0.06||0.0012|TWO_SIDED|95.0|-0.37|-0.11|||ANCOVA|Treatment as a fixed effect and log10 transformed baseline SPD as a covariate.||||-0.11|-0.37|0.0012
72503877|NCT01157169|144539083|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|93.28|||||TWO_SIDED|90.0|85.37|101.93|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||101.93|85.37|
72503878|NCT01157169|144539084|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|94.19|||||TWO_SIDED|90.0|87.44|101.46|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||101.46|87.44|
72503879|NCT01157169|144539085|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|95.06|||||TWO_SIDED|90.0|86.56|104.39|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||104.39|86.56|
72503880|NCT02396147|144539093|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|87.09|||||TWO_SIDED|90.0|58.56|129.52|||||T4 Formulation B Fasted (test)/T2 Formulation Fasted (reference)\*100|||129.52|58.56|
72503881|NCT02396147|144539093|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|83.09|||||TWO_SIDED|90.0|59.95|115.18|||||T4 Formulation C Fasted (test)/T2 Formulation Fasted (reference) \* 100|||115.18|59.95|
72503882|NCT02396147|144539093|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|78.59|||||TWO_SIDED|90.0|52.88|116.79|||||T4 Formulation B Fed (test)/T4 Formulation B Fasted (reference) \* 100|||116.79|52.88|
72503883|NCT02396147|144539093|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|94.23|||||TWO_SIDED|90.0|67.98|130.61|||||T4 Formulation C Fed (test)/T4 Formulation C Fasted (reference) \* 100|||130.61|67.98|
72503884|NCT02396147|144539094|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|94.53|||||TWO_SIDED|90.0|74.83|119.4|||||T4 Formulation B Fasted (test)/T2 Formulation Fasted (Reference) \*100|||119.40|74.83|
72503885|NCT02396147|144539094|SUPERIORITY_OR_OTHER||Geometric Mean Ration|77.99|||||TWO_SIDED|90.0|64.29|94.61|||||T4 Formulation C Fasted (test)/T2 Formulation Fasted (reference) \* 100|||94.61|64.29|
72503886|NCT02396147|144539094|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|81.08|||||TWO_SIDED|90.0|64.21|102.37|||||T4 Formulation B Fed (test)/T4 Formulation B Fasted (reference) \* 100|||102.37|64.21|
72503887|NCT02396147|144539094|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|92.78|||||TWO_SIDED|90.0|76.48|112.55|||||T4 Formulation C Fed (test)/T4 Formulation C Fasted (reference) \* 100|||112.55|76.48|
72503888|NCT02396147|144539095|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|94.43|||||TWO_SIDED|90.0|74.85|119.12|||||T4 Formulation B Fasted (test)/T2 Formulation Fasted (reference) \* 100|||119.12|74.85|
72621816|NCT00581100|144773969|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Adjusted change calculated from mixed model. Model for change-\[Group visit Group\*visit baseline baseline\*visit\].|Mixed Models Analysis|||||||<0.0001
72503889|NCT02396147|144539095|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|78.09|||||TWO_SIDED|90.0|64.53|94.51|||||T4 Formulation C Fasted (test)/T2 Formulation Fasted (reference) \* 100|||94.51|64.53|
72503890|NCT02396147|144539095|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|81.16|||||TWO_SIDED|90.0|64.36|102.34|||||T4 Formulation B Fed (test)/T4 Formulation B Fasted (reference) \* 100|||102.34|64.36|
72503891|NCT02396147|144539095|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|92.99|||||TWO_SIDED|90.0|76.84|112.54|||||T4 Formulation C Fed (test)/T4 Formulation C Fasted (reference) \* 100|||112.54|76.84|
72503892|NCT01362322|144539113|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was demonstrated if the upper limit (UL) of the 95% confidence interval (CI) on the geometric mean concentration (GMC) ratios \[Boostrix-Prev Group over Boostrix-New Group\] for anti-diphtheria (anti-D) antibodies was ≤ 1.5 (clinical limit for non-inferiority).|Adjusted radio|0.96|||||TWO_SIDED|95.0|0.85|1.09|||ANCOVA|||Analysis was performed to demonstrate that Boostrix administered using the new syringe presentation was non-inferior to Boostrix administered using the previous syringe presentation, in terms of immune response to diphteria vaccine antigens, one month after booster vaccination.||1.09|0.85|
72503893|NCT01362322|144539113|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was demonstrated if the upper limit (UL) of the 95% confidence interval (CI) on the geometric mean concentration (GMC) ratios \[Boostrix-Prev Group over Boostrix-New Group\] for anti-tetanus (anti-T) antibodies was ≤ 1.5 (clinical limit for non-inferiority).|Adjusted Ratio|0.97|||||TWO_SIDED|95.0|0.86|1.1|||ANCOVA|||Analysis was performed to demonstrate that Boostrix administered using the new syringe presentation was non-inferior to Boostrix administered using the previous syringe presentation, in terms of immune response to tetanus vaccine antigens, one month after booster vaccination.||1.1|0.86|
72503894|NCT01362322|144539114|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was demonstrated if the upper limit (UL) of the 95% confidence interval (CI) on the geometric mean concentration (GMC) ratios \[Boostrix-Prev Group over Boostrix-New Group\] for anti-pertussis toxoid (anti-PT) antibodies was ≤ 1.5 (clinical limit for non-inferiority).|Adjusted Ratio|0.92|||||TWO_SIDED|95.0|0.82|1.04|||ANCOVA|||Analysis was performed to demonstrate that Boostrix administered using the new syringe presentation was non-inferior to Boostrix administered using the previous syringe presentation, in terms of immune response to pertussis toxoid vaccine antigens, one month after booster vaccination.||1.04|0.82|
72621817|NCT00581100|144773969|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Adjusted change calculated from mixed model. Model for change-\[Group visit Group\*visit baseline baseline\*visit\].|Mixed Models Analysis|||||||<0.0001
72621818|NCT00581100|144773970|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value from generalized linear models for correlated data using Generalized Estimating Equations (GEE) with treatment and visits as fixed factors. Model for proportion=\[Group visit Group\*visit\].|GEE model|||||||<0.001
72621819|NCT00581100|144773970|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value from generalized linear models for correlated data using Generalized Estimating Equations (GEE) with treatment and visits as fixed factors. Model for proportion=\[Group visit Group\*visit\].|GEE model|||||||<0.001
72394589|NCT02310568|144295793|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.48||0.356|TWO_SIDED|90.0|-1.3|0.4|||Mixed-Effects Model Repeated Measure|||(PF-06372865 2.5 mg - Placebo). Week 5: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||0.4|-1.3|0.356
72394590|NCT02310568|144295793|SUPERIORITY_OR_OTHER||LS Mean Difference|0.6|STANDARD_ERROR_OF_MEAN|0.45||0.18|TWO_SIDED|90.0|-0.2|1.4|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 5: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||1.4|-0.2|0.180
72467425|NCT00551135|144457998|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3082|TWO_SIDED||||||ANOVA|||Day 8 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.3082
72467426|NCT00551135|144457998|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4373|TWO_SIDED||||||ANOVA|||Day 8 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.4373
72467427|NCT00551135|144457998|SUPERIORITY_OR_OTHER_LEGACY|||||||0.654|TWO_SIDED||||||ANOVA|||Day 8 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.6540
72467428|NCT00551135|144457998|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0002|TWO_SIDED||||||ANOVA|||Day 9 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0002
72467429|NCT00551135|144457998|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0696|TWO_SIDED||||||ANOVA|||Day 9 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0696
72503895|NCT01362322|144539114|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was demonstrated if the upper limit (UL) of the 95% confidence interval (CI) on the geometric mean concentration (GMC) ratios \[Boostrix-Prev Group over Boostrix-New Group\] for anti-filamentous haemagglutinin (anti-FHA) antibodies was ≤ 1.5 (clinical limit for non-inferiority).|Adjusted Ratio|0.92|||||TWO_SIDED|95.0|0.83|1.03||||||Analysis was performed to demonstrate that Boostrix administered using the new syringe presentation was non-inferior to Boostrix administered using the previous syringe presentation, in terms of immune response to filamentous haemagglutinin vaccine antigens, one month after booster vaccination.||1.03|0.83|
72504864|NCT02435173|144540747|SUPERIORITY||Adjusted means difference|40.13|STANDARD_ERROR_OF_MEAN|5.04|<|0.0001|TWO_SIDED|95.0|28.51|51.75|||ANCOVA|Treatment as a fixed effect and baseline as a covariate.||||51.75|28.51|<0.0001
72467430|NCT00551135|144457998|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0029|TWO_SIDED||||||ANOVA|||Day 9 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0029
72467431|NCT00551135|144457998|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3695|TWO_SIDED||||||ANOVA|||Day 10 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.3695
72467432|NCT00551135|144457998|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9346|TWO_SIDED||||||ANOVA|||Day 10 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.9346
72467433|NCT00551135|144457998|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9631|TWO_SIDED||||||ANOVA|||Day 10 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.9631
72467434|NCT00551135|144457999|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9025|TWO_SIDED||||||ANOVA|||"LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.~Last observation carried forward or first non-missing observation carried backward algorithm applied to missing scores 1-3 h PS and independently to missing scores 24-48 h PS, before applying trapezoidal rule to compute AUC. AUC=missing if all scores 1-3 or 24-48 h PS missing."||||0.9025
72504865|NCT03216265|144540763|OTHER||Least Square Mean difference|-1.44|||<|0.0001|TWO_SIDED|95.0|-2.1|-0.78|||ANCOVA|Analysis model (ANCOVA) included participant as random effect, treatment arm and side of body as fixed effects, and baseline value as covariate.|Difference is the first named treatment adjusted (LS) mean change from baseline (Visit 2) minus the second named treatment adjusted mean change from baseline (Visit 2).|||-0.78|-2.10|<0.0001
72504866|NCT01539837|144540818|SUPERIORITY||||||<|0.01||||||calculated|Pairwise comparisons,post-hoc Bonferoni|||||||<0.01
72467435|NCT00551135|144457999|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5652|TWO_SIDED||||||ANOVA|||"LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.~Last observation carried forward or first non-missing observation carried backward algorithm applied to missing scores 1-3 h PS and independently to missing scores 24-48 h PS, before applying trapezoidal rule to compute AUC. AUC=missing if all scores 1-3 or 24-48 h PS missing."||||0.5652
72467436|NCT00551135|144457999|SUPERIORITY_OR_OTHER_LEGACY|||||||0.792|TWO_SIDED||||||ANOVA|||"LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.~Last observation carried forward or first non-missing observation carried backward algorithm applied to missing scores 1-3 h PS and independently to missing scores 24-48 h PS, before applying trapezoidal rule to compute AUC. AUC=missing if all scores 1-3 or 24-48 h PS missing."||||0.7920
72467437|NCT00551135|144458000|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6679|TWO_SIDED||||||ANOVA|||2 h BS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.6679
72467438|NCT00551135|144458000|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7308|TWO_SIDED||||||ANOVA|||2 h BS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.7308
72394591|NCT02310568|144295793|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|0.53||0.589|TWO_SIDED|90.0|-0.6|1.2|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - Placebo). Week 6: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||1.2|-0.6|0.589
72394592|NCT02310568|144295793|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.51||0.873|TWO_SIDED|90.0|-0.8|1.0|||Mixed-Effects Model Repeated Measure|||(PF-06372865 2.5 mg - Placebo). Week 6: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||1.0|-0.8|0.873
72503896|NCT01362322|144539114|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was demonstrated if the upper limit (UL) of the 95% confidence interval (CI) on the geometric mean concentration (GMC) ratios \[Boostrix-Prev Group over Boostrix-New Group\] for anti-pertactin (anti-PRN) antibodies was ≤ 1.5 (clinical limit for non-inferiority).|Adjusted ratio|0.98|||||TWO_SIDED|95.0|0.85|1.13||||||Analysis was performed to demonstrate that Boostrix administered using the new syringe presentation was non-inferior to Boostrix administered using the previous syringe presentation, in terms of immune response to pertactin vaccine antigens, one month after booster vaccination.||1.13|0.85|
72503897|NCT00320671|144539152|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence Analysis|Cumulative Response Rates|56.8||||0.61|TWO_SIDED|95.0|43.9|69.9|||Log Rank||Only the subjects taking risperidone were analysed in this section|||69.9|43.9|.61
72394593|NCT02310568|144295793|SUPERIORITY_OR_OTHER||LS Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|0.48||0.667|TWO_SIDED|90.0|-0.6|1.0|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 6: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||1.0|-0.6|0.667
72467439|NCT00551135|144458000|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6781|TWO_SIDED||||||ANOVA|||2 h BS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.6781
72467440|NCT00551135|144458000|SUPERIORITY_OR_OTHER_LEGACY|||||||0.093|TWO_SIDED||||||ANOVA|||1 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0930
72467441|NCT00551135|144458000|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3751|TWO_SIDED||||||ANOVA|||1 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.3751
72467442|NCT00551135|144458000|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0111|TWO_SIDED||||||ANOVA|||1 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0111
72467443|NCT00551135|144458000|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6811|TWO_SIDED||||||ANOVA|||2 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.6811
72467444|NCT00551135|144458000|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7426|TWO_SIDED||||||ANOVA|||2 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.7426
72467445|NCT00551135|144458000|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1619|TWO_SIDED||||||ANOVA|||2 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.1619
72467446|NCT00551135|144458000|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1132|TWO_SIDED||||||ANOVA|||3 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.1132
72467447|NCT00551135|144458000|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9822|TWO_SIDED||||||ANOVA|||3 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.9822
72467448|NCT00551135|144458000|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1883|TWO_SIDED||||||ANOVA|||3 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.1883
72503898|NCT00320671|144539152|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence Analysis|Cumulative Response Rates|62.8||||0.61|TWO_SIDED|95.0|50.8|74.8|||Log Rank||Only subjects taking aripiprazole were analysed in this section|||74.8|50.8|.61
72503899|NCT03334214|144539153|SUPERIORITY|||||||0.003|||||||ANOVA|||||||0.003
72467449|NCT00551135|144458000|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9391|TWO_SIDED||||||ANOVA|||Day 1 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.9391
72467450|NCT00551135|144458000|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9664|TWO_SIDED||||||ANOVA|||Day 1 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.9664
72467451|NCT00551135|144458000|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0747|TWO_SIDED||||||ANOVA|||Day 1 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0747
72467452|NCT00551135|144458000|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9681|TWO_SIDED||||||ANOVA|||Day 2 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.9681
72467453|NCT00551135|144458000|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3246|TWO_SIDED||||||ANOVA|||Day 2 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.3246
72467454|NCT00551135|144458000|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7984|TWO_SIDED||||||ANOVA|||Day 2 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.7984
72394594|NCT02310568|144295793|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|0.47||0.548|TWO_SIDED|90.0|-0.5|1.1|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - Placebo). Week 7: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||1.1|-0.5|0.548
72394595|NCT02310568|144295793|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.45||0.567|TWO_SIDED|90.0|-1.0|0.5|||Mixed-Effects Model Repeated Measure|||(PF-06372865 2.5 mg - Placebo). Week 7: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||0.5|-1.0|0.567
72394596|NCT02310568|144295793|SUPERIORITY_OR_OTHER||LS Mean Difference|0.6|STANDARD_ERROR_OF_MEAN|0.42||0.208|TWO_SIDED|90.0|-0.2|1.3|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 7: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||1.3|-0.2|0.208
72503900|NCT03334214|144539154|SUPERIORITY|||||||0.026|||||||ANOVA|||||||0.026
72503901|NCT03334214|144539157|SUPERIORITY|||||||0.024|||||||ANOVA|||||||0.024
72503902|NCT03334214|144539158|SUPERIORITY|||||||0.0774|||||||Cochran-Mantel-Haenszel|The p-value is obtained using Cochran-Mantel-Haenszel (CMH) test stratified by the baseline liver fat stratum (\<20%, ≥20%) stratification factor.||||||0.0774
72503903|NCT03334214|144539159|SUPERIORITY|||||||0.183|||||||ANOVA|||||||0.183
72503904|NCT03334214|144539160|SUPERIORITY|||||||0.682|||||||ANOVA|||Total Cholesterol||||0.682
72503905|NCT03334214|144539160|SUPERIORITY|||||||0.716|||||||ANOVA|||ApoB||||0.716
72503906|NCT03334214|144539160|SUPERIORITY|||||||0.717|||||||ANOVA|||HDL||||0.717
72370720|NCT00488683|144251643|SUPERIORITY_OR_OTHER||R-square|0.02||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between memory B cells one month after primary vaccination and rise in serogroup specific IgG concentration after booster vaccination age for the serogroup C||||
72370721|NCT00488683|144251643|SUPERIORITY_OR_OTHER||R-square|0.0048||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and rise in serogroup specific IgG concentration after booster vaccination age for the serogroup W-135||||
72503907|NCT03334214|144539160|SUPERIORITY|||||||0.463|||||||ANOVA|||LDL-C||||0.463
72503908|NCT03334214|144539160|SUPERIORITY|||||||0.555|||||||ANOVA|||Non-HDL||||0.555
72503909|NCT03334214|144539160|SUPERIORITY|||||||0.619|||||||ANOVA|||Triglycerides||||0.619
72503910|NCT03334214|144539160|SUPERIORITY|||||||0.698|||||||ANOVA|||VLDL-C||||0.698
72503911|NCT03334214|144539161|SUPERIORITY|||||||0.902|||||||ANOVA|||FPG||||0.902
72503912|NCT03334214|144539161|SUPERIORITY|||||||0.267|||||||Van Elteren test|||HOMA-IR||||0.267
72503913|NCT03334214|144539161|SUPERIORITY|||||||0.2|||||||Van Elteren test|||Insulin||||0.200
72503914|NCT03334214|144539162|SUPERIORITY|||||||0.933|||||||ANOVA|||||||0.933
72370722|NCT00488683|144251643|SUPERIORITY_OR_OTHER||R-square|0.0018||||||95.0|||||Regression, Linear||Values from Groups 2 and 3 were combined for this analysis.|Linear regression coefficient between memory B cells one month after primary vaccination and rise in serogroup specific IgG concentration after booster vaccination age for the serogroup W-135||||
72370723|NCT00488683|144251643|SUPERIORITY_OR_OTHER||R-square|0.01||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and rise in serogroup specific IgG concentration after booster vaccination age for the serogroup Y||||
72370724|NCT00488683|144251643|SUPERIORITY_OR_OTHER||R-square|0.0||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between memory B cells one month after primary vaccination and rise in serogroup specific IgG concentration after booster vaccination age for the serogroup Y||||
72370725|NCT00488683|144251643|SUPERIORITY_OR_OTHER||R-square|0.27||||||95.0|||||Regression, Linear|||Linear regression coefficient between demographic factors, memory B cells one month after primary vaccination and rise in serogroup specific IgG concentration after booster vaccination age for the serogroup A||||
72370726|NCT00488683|144251643|SUPERIORITY_OR_OTHER||R-square|0.19||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between demographic factors, memory B cells one month after primary vaccination and rise in serogroup specific IgG concentration after booster vaccination age for the serogroup A||||
72370727|NCT00488683|144251643|SUPERIORITY_OR_OTHER||R-square|0.08||||||95.0|||||Regression, Linear|||Linear regression coefficient between demographic factors, memory B cells one month after primary vaccination and rise in serogroup specific IgG concentration after booster vaccination age for the serogroup C||||
72370728|NCT00488683|144251643|SUPERIORITY_OR_OTHER||R-square|0.08||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between demographic factors, memory B cells one month after primary vaccination and rise in serogroup specific IgG concentration after booster vaccination age for the serogroup C||||
72370729|NCT00488683|144251643|SUPERIORITY_OR_OTHER||R-square|0.45||||0.0436||95.0|||||Regression, Linear|||Linear regression coefficient between demographic factors, memory B cells one month after primary vaccination and rise in serogroup specific IgG concentration after booster vaccination age for the serogroup W-135||||0.0436
72370730|NCT00488683|144251643|SUPERIORITY_OR_OTHER||R-square|0.17||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between demographic factors, memory B cells one month after primary vaccination and rise in serogroup specific IgG concentration after booster vaccination age for the serogroup W-135||||
72370731|NCT00488683|144251643|SUPERIORITY_OR_OTHER||R-square|0.37||||||95.0|||||Regression, Linear|||Linear regression coefficient between demographic factors, memory B cells one month after primary vaccination and rise in serogroup specific IgG concentration after booster vaccination age for the serogroup Y||||
72370732|NCT00488683|144251643|SUPERIORITY_OR_OTHER||R-square|0.07||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between demographic factors, memory B cells one month after primary vaccination and rise in serogroup specific IgG concentration after booster vaccination age for the serogroup Y||||
72621820|NCT00581100|144773971|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value from generalized linear models for correlated data using Generalized Estimating Equations (GEE) with treatment and visits as fixed factors. Model for proportion=\[Group visit Group\*visit\].|GEE model|||||||<0.001
72621821|NCT00581100|144773971|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value from generalized linear models for correlated data using Generalized Estimating Equations (GEE) with treatment and visits as fixed factors. Model for proportion=\[Group visit Group\*visit\].|GEE model|||||||<0.001
72621822|NCT00581100|144773972|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Adjusted change calculated from mixed-model. Model for change=\[Group visit Group\*visit baseline baseline\*visit\].|Mixed Models Analysis|||||||<0.0001
72467455|NCT00551135|144458000|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8581|TWO_SIDED||||||ANOVA|||Day 3 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.8581
72503915|NCT01025336|144539184|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.4|||||TWO_SIDED|95.0|0.32|0.46|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 1: Geometric mean fold rise (GMFR) was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.46|0.32|
72394597|NCT02310568|144295793|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.6||0.858|TWO_SIDED|90.0|-1.2|0.9|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - Placebo). Week 8: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||0.9|-1.2|0.858
72467456|NCT00551135|144458000|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9677|TWO_SIDED||||||ANOVA|||Day 3 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.9677
72467457|NCT00551135|144458000|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7104|TWO_SIDED||||||ANOVA|||Day 3 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.7104
72503916|NCT01025336|144539184|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.3|||||TWO_SIDED|95.0|0.3|0.41|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 1: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.41|0.30|
72621823|NCT00581100|144773972|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Adjusted change calculated from mixed-model. Model for change=\[Group visit Group\*visit baseline baseline\*visit\].|Mixed Models Analysis|||||||<0.0001
72621824|NCT00581100|144773973|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Adjusted change calculated from mixed model. Model for change=\[Group visit Group\*visit baseline baseline\*visit\].|Mixed Models Analysis|||||||<0.0001
72621825|NCT00581100|144773973|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Adjusted change calculated from mixed model. Model for change=\[Group visit Group\*visit baseline baseline\*visit\].|Mixed Models Analysis|||||||<0.0001
72621826|NCT00581100|144773974|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Adjusted change calculated from mixed model. Model for change=\[Group visit Group\*visit baseline baseline\*visit\].|Mixed Models Analysis|||||||<0.0001
72621827|NCT00581100|144773974|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||\<Table 8-14\> Change from baseline in Physician and Patient Assessment of Nail Psoriasis Activity Visual Analog Scale (VAS)|Mixed Models Analysis|||||||<0.0001
72621828|NCT00581100|144773975|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Adjusted change calculated from mixed-model. Model for change=\[Group visit Group\*visit baseline baseline\*visit\].|Mixed Models Analysis|||||||<0.0001
72621829|NCT00581100|144773975|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Adjusted change calculated from mixed-model. Model for change=\[Group visit Group\*visit baseline baseline\*visit\].|Mixed Models Analysis|||||||<0.0001
72467458|NCT00551135|144458000|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8978|TWO_SIDED||||||ANOVA|||Day 4 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.8978
72467459|NCT00551135|144458000|SUPERIORITY_OR_OTHER_LEGACY|||||||0.626|TWO_SIDED||||||ANOVA|||Day 4 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.6260
72467460|NCT00551135|144458000|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4047|TWO_SIDED||||||ANOVA|||Day 4 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.4047
72467461|NCT00551135|144458000|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4461|TWO_SIDED||||||ANOVA|||Day 5 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.4461
72467462|NCT00551135|144458000|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9099|TWO_SIDED||||||ANOVA|||Day 5 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.9099
72467463|NCT00551135|144458000|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8805|TWO_SIDED||||||ANOVA|||Day 5 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.8805
72503917|NCT01025336|144539184|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.5|||||TWO_SIDED|95.0|0.44|0.61|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 1: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.61|0.44|
72503918|NCT01025336|144539184|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.2|||||TWO_SIDED|95.0|0.17|0.25|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 3: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.25|0.17|
72503919|NCT01025336|144539184|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.2|||||TWO_SIDED|95.0|0.18|0.24|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 3: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.24|0.18|
72467464|NCT00551135|144458000|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2348|TWO_SIDED||||||ANOVA|||Day 6 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.2348
72467465|NCT00551135|144458000|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4445|TWO_SIDED||||||ANOVA|||Day 6 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.4445
72467466|NCT00551135|144458000|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8849|TWO_SIDED||||||ANOVA|||Day 6 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.8849
72467467|NCT00551135|144458000|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2796|TWO_SIDED||||||ANOVA|||Day 7 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.2796
72467468|NCT00551135|144458000|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5225|TWO_SIDED||||||ANOVA|||Day 7 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.5225
72467469|NCT00551135|144458000|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7015|TWO_SIDED||||||ANOVA|||Day 7 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.7015
72467470|NCT00551135|144458004|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3332|TWO_SIDED||||||ANOVA|||Day 2 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.3332
72467471|NCT00551135|144458004|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0933|TWO_SIDED||||||ANOVA|||Day 2 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0933
72467472|NCT00551135|144458004|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0031|TWO_SIDED||||||ANOVA|||Day 2 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0031
72467473|NCT00551135|144458004|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9451|TWO_SIDED||||||ANOVA|||Day 3 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.9451
72467474|NCT00551135|144458004|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7312|TWO_SIDED||||||ANOVA|||Day 3 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.7312
72467475|NCT00551135|144458004|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0348|TWO_SIDED||||||ANOVA|||Day 3 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0348
72467476|NCT00551135|144458004|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8936|TWO_SIDED||||||ANOVA|||Day 4 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.8936
72467477|NCT00551135|144458004|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7672|TWO_SIDED||||||ANOVA|||Day 4 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.7672
72467478|NCT00551135|144458004|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4285|TWO_SIDED||||||ANOVA|||Day 4 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.4285
72394598|NCT02310568|144295793|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.58||0.329|TWO_SIDED|90.0|-1.7|0.3|||Mixed-Effects Model Repeated Measure|||(PF-06372865 2.5 mg - Placebo). Week 8: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||0.3|-1.7|0.329
72394599|NCT02310568|144295793|SUPERIORITY_OR_OTHER||LS Mean Difference|0.5|STANDARD_ERROR_OF_MEAN|0.54||0.272|TWO_SIDED|90.0|-0.4|1.5|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 8: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||1.5|-0.4|0.272
72394600|NCT02310568|144295793|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.33||0.946|TWO_SIDED|90.0|-0.6|0.5|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - Placebo). Combined Stage 1 (Week 4) and Stage 2 (Week 8): Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect.||0.5|-0.6|0.946
72394601|NCT02310568|144295793|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.31||0.407|TWO_SIDED|90.0|-0.8|0.3|||Mixed-Effects Model Repeated Measure|||(PF-06372865 2.5 mg - Placebo). Combined Stage 1 (Week 4) and Stage 2 (Week 8): Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect.||0.3|-0.8|0.407
72467479|NCT00551135|144458004|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0785|TWO_SIDED||||||ANOVA|||Day 5 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0785
72467480|NCT00551135|144458004|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3348|TWO_SIDED||||||ANOVA|||Day 5 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.3348
72467481|NCT00551135|144458004|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1366|TWO_SIDED||||||ANOVA|||Day 5 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.1366
72467482|NCT00551135|144458004|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3338|TWO_SIDED||||||ANOVA|||Day 6 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.3338
72394602|NCT02310568|144295793|SUPERIORITY_OR_OTHER||LS Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|0.31||0.436|TWO_SIDED|90.0|-0.3|0.8|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Combined Stage 1 (Week 4) and Stage 2 (Week 8): Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect.||0.8|-0.3|0.436
72394603|NCT02310568|144295794|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.21||0.325|TWO_SIDED|90.0|-0.6|0.1|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - Placebo). Week 1: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect.||0.1|-0.6|0.325
72467483|NCT00551135|144458004|SUPERIORITY_OR_OTHER_LEGACY|||||||0.446|TWO_SIDED||||||ANOVA|||Day 6 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.4460
72467484|NCT00551135|144458004|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1078|TWO_SIDED||||||ANOVA|||Day 6 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.1078
72467485|NCT00551135|144458004|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8273|TWO_SIDED||||||ANOVA|||Day 7 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.8273
72467486|NCT00551135|144458004|SUPERIORITY_OR_OTHER_LEGACY|||||||0.614|TWO_SIDED||||||ANOVA|||Day 7 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.6140
72467487|NCT00551135|144458004|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1684|TWO_SIDED||||||ANOVA|||Day 7 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.1684
72467488|NCT00551135|144458004|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1285|TWO_SIDED||||||ANOVA|||Day 8 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.1285
72467489|NCT00551135|144458004|SUPERIORITY_OR_OTHER_LEGACY|||||||0.264|TWO_SIDED||||||ANOVA|||Day 8 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.2640
72467490|NCT00551135|144458004|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8956|TWO_SIDED||||||ANOVA|||Day 8 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.8956
72467491|NCT00551135|144458004|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0058|TWO_SIDED||||||ANOVA|||Day 9 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0058
72564747|NCT03827018|144660999|SUPERIORITY||Hazard Ratio (HR)|0.43||||0.0378|TWO_SIDED|95.0|0.19|0.98||Calculated by using a log-rank test stratified by randomization strata.|Log Rank||Calculated based on a Cox proportional-hazards model with treatment as covariate, and stratified by randomization strata.|Secondary endpoints were analyzed in hierarchical order.||0.98|0.19|0.0378
72467492|NCT00551135|144458004|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9929|TWO_SIDED||||||ANOVA|||Day 9 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.9929
72467493|NCT00551135|144458004|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0473|TWO_SIDED||||||ANOVA|||Day 9 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0473
72467494|NCT00551135|144458004|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2426|TWO_SIDED||||||ANOVA|||Day 10 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.2426
72394604|NCT02310568|144295794|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.2||0.996|TWO_SIDED|90.0|-0.3|0.3|||Mixed-Effects Model Repeated Measure|||(PF-06372865 2.5 mg - Placebo). Week 1: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||0.3|-0.3|0.996
72394605|NCT02310568|144295794|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.24||0.377|TWO_SIDED|90.0|-0.6|0.2|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 1: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||0.2|-0.6|0.377
72394606|NCT02310568|144295794|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.24||0.291|TWO_SIDED|90.0|-0.7|0.1|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - Placebo). Week 2: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||0.1|-0.7|0.291
72394607|NCT02310568|144295794|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.24||0.925|TWO_SIDED|90.0|-0.4|0.4|||Mixed-Effects Model Repeated Measure|||(PF-06372865 2.5 mg - Placebo). Week 2: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||0.4|-0.4|0.925
72394608|NCT02310568|144295794|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.27||0.39|TWO_SIDED|90.0|-0.7|0.2|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 2: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||0.2|-0.7|0.390
72467495|NCT00551135|144458004|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3478|TWO_SIDED||||||ANOVA|||Day 10 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.3478
72467496|NCT00551135|144458004|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1694|TWO_SIDED||||||ANOVA|||Day 10 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.1694
72467497|NCT00551135|144458005|SUPERIORITY_OR_OTHER_LEGACY|||||||0.063|TWO_SIDED||||||ANOVA|||24 h PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0630
72467498|NCT00551135|144458005|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0347|TWO_SIDED||||||ANOVA|||24 h PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0347
72467499|NCT00551135|144458005|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0024|TWO_SIDED||||||ANOVA|||24 h PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0024
72467500|NCT00551135|144458005|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0767|TWO_SIDED||||||ANOVA|||48 h PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0767
72467501|NCT00551135|144458005|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1327|TWO_SIDED||||||ANOVA|||48 h PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.1327
72467502|NCT00551135|144458005|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0078|TWO_SIDED||||||ANOVA|||48 h PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0078
72503920|NCT01025336|144539184|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.4|||||TWO_SIDED|95.0|0.31|0.41|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 3: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.41|0.31|
72467503|NCT00551135|144458005|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0694|TWO_SIDED||||||ANOVA|||72 h PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0694
72467504|NCT00551135|144458005|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2173|TWO_SIDED||||||ANOVA|||72 h PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.2173
72467505|NCT00551135|144458005|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0193|TWO_SIDED||||||ANOVA|||72 h PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0193
72467506|NCT00551135|144458005|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0673|TWO_SIDED||||||ANOVA|||Day 4 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0673
72467507|NCT00551135|144458005|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2629|TWO_SIDED||||||ANOVA|||Day 4 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.2629
72503921|NCT01025336|144539184|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.2|||||TWO_SIDED|95.0|0.19|0.32|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 4: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.32|0.19|
72467508|NCT00551135|144458005|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0388|TWO_SIDED||||||ANOVA|||Day 4 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0388
72467509|NCT00551135|144458005|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0651|TWO_SIDED||||||ANOVA|||Day 5 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0651
72467510|NCT00551135|144458005|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3242|TWO_SIDED||||||ANOVA|||Day 5 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.3242
72503922|NCT01025336|144539184|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.3|||||TWO_SIDED|95.0|0.22|0.33|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 4: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.33|0.22|
72503923|NCT01025336|144539184|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.2|||||TWO_SIDED|95.0|0.17|0.3|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 4: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.30|0.17|
72503924|NCT01025336|144539184|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.3|||||TWO_SIDED|95.0|0.25|0.39|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 5: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.39|0.25|
72503925|NCT01025336|144539184|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.3|||||TWO_SIDED|95.0|0.27|0.38|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 5: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.38|0.27|
72503926|NCT01025336|144539184|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.5|||||TWO_SIDED|95.0|0.44|0.6|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 5: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.60|0.44|
72503927|NCT01025336|144539184|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.1|||||TWO_SIDED|95.0|0.1|0.2|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 6A: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.20|0.10|
72503928|NCT01025336|144539184|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.2|||||TWO_SIDED|95.0|0.17|0.25|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 6A: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.25|0.17|
72503929|NCT01025336|144539184|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.1|||||TWO_SIDED|95.0|0.09|0.16|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 6A: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.16|0.09|
72503930|NCT01025336|144539184|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.5|||||TWO_SIDED|95.0|0.41|0.62|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 6B: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.62|0.41|
72503931|NCT01025336|144539184|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.5|||||TWO_SIDED|95.0|0.43|0.62|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 6B: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.62|0.43|
72503932|NCT01025336|144539184|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.5|||||TWO_SIDED|95.0|0.38|0.59|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 6B: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.59|0.38|
72503933|NCT01025336|144539184|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.8|||||TWO_SIDED|95.0|0.6|1.0|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 7F: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||1.00|0.60|
72503934|NCT01025336|144539184|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.6|||||TWO_SIDED|95.0|0.51|0.75|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 7F: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.75|0.51|
72564748|NCT03827018|144661000|SUPERIORITY||Hazard Ratio (HR)|0.49||||0.0651|TWO_SIDED|95.0|0.22|1.06||Calculated by using a log-rank test stratified by randomization strata.|Log Rank||Calculated based on a Cox proportional-hazards model with treatment as covariate, and stratified by randomization strata.|Secondary endpoints were analyzed in hierarchical order.||1.06|0.22|0.0651
72503935|NCT01025336|144539184|SUPERIORITY_OR_OTHER||geometric mean fold rise|1.1|||||TWO_SIDED|95.0|0.86|1.46|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 7F: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||1.46|0.86|
72503936|NCT01025336|144539184|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.6|||||TWO_SIDED|95.0|0.41|0.8|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 9V: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.80|0.41|
72503937|NCT01025336|144539184|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.5|||||TWO_SIDED|95.0|0.39|0.73|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 9V: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.73|0.39|
72503938|NCT01025336|144539184|SUPERIORITY_OR_OTHER||geometric mean fold rise|1.1|||||TWO_SIDED|95.0|0.78|1.67|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 9V: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||1.67|0.78|
72503939|NCT01025336|144539184|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.9|||||TWO_SIDED|95.0|0.71|1.08|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 14: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||1.08|0.71|
72503940|NCT01025336|144539184|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.6|||||TWO_SIDED|95.0|0.54|0.75|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 14: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.75|0.54|
72503941|NCT01025336|144539184|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.9|||||TWO_SIDED|95.0|0.78|1.06|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 14: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||1.06|0.78|
72503942|NCT01025336|144539184|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.4|||||TWO_SIDED|95.0|0.29|0.51|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 18C: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.51|0.29|
72503943|NCT01025336|144539184|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.5|||||TWO_SIDED|95.0|0.39|0.56|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 18C: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.56|0.39|
72503944|NCT01025336|144539184|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.6|||||TWO_SIDED|95.0|0.53|0.69|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 18C: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.69|0.53|
72503945|NCT01025336|144539184|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.6|||||TWO_SIDED|95.0|0.49|0.69|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 19A: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.69|0.49|
72503946|NCT01025336|144539184|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.6|||||TWO_SIDED|95.0|0.52|0.63|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 19A: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.63|0.52|
72503947|NCT01025336|144539184|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.6|||||TWO_SIDED|95.0|0.53|0.66|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 19A: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.66|0.53|
72564749|NCT03827018|144661001|OTHER|Descriptive statistic|Least Squares (LS) means difference|-326.45||||0.0667|TWO_SIDED|95.0|-675.99|23.09||Calculated using ANCOVA with treatment arm and randomization strata as discrete variables, and corticosteroid starting dose as a continuous variable.|ANCOVA|||||23.09|-675.99|0.0667
72503948|NCT01025336|144539184|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.5|||||TWO_SIDED|95.0|0.42|0.64|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 19F: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.64|0.42|
72503949|NCT01025336|144539184|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.5|||||TWO_SIDED|95.0|0.44|0.6|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 19F: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.60|0.44|
72503950|NCT01025336|144539184|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.7|||||TWO_SIDED|95.0|0.63|0.88|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 19F: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.88|0.63|
72503951|NCT01025336|144539184|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.2|||||TWO_SIDED|95.0|0.15|0.26|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 23F: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.26|0.15|
72503952|NCT01025336|144539184|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.3|||||TWO_SIDED|95.0|0.23|0.35|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 23F: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.35|0.23|
72503953|NCT01025336|144539184|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.3|||||TWO_SIDED|95.0|0.28|0.43|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 23F: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.43|0.28|
72564750|NCT03827018|144661002|OTHER|Descriptive statistic|Difference in percentages|31.0||||0.0201|TWO_SIDED|95.0|11.1|50.8||95% CI and p-value are analyzed using a Cochran-Mantel-Haenszel (CMH) test stratified by randomization strata|Cochran-Mantel-Haenszel|||||50.8|11.1|0.0201
72467511|NCT00551135|144458005|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0345|TWO_SIDED||||||ANOVA|||Day 5 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0345
72467512|NCT00551135|144458005|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0487|TWO_SIDED||||||ANOVA|||Day 6 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0487
72467513|NCT00551135|144458005|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3384|TWO_SIDED||||||ANOVA|||Day 6 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.3384
72467514|NCT00551135|144458005|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0467|TWO_SIDED||||||ANOVA|||Day 6 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0467
72467515|NCT00551135|144458005|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0347|TWO_SIDED||||||ANOVA|||Day 7 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0347
72503954|NCT01025336|144539185|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.5|||||TWO_SIDED|95.0|0.42|0.56|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 1: Geometric mean fold rises (GMFRs) were calculated using all subjects with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.56|0.42|
72503955|NCT01025336|144539185|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.6|||||TWO_SIDED|95.0|0.56|0.72|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 1: Geometric mean fold rises (GMFRs) were calculated using all subjects with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.72|0.56|
72503956|NCT01025336|144539185|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.4|||||TWO_SIDED|95.0|0.35|0.45|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 3: Geometric mean fold rises (GMFRs) were calculated using all subjects with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.45|0.35|
72564751|NCT03827018|144661003|OTHER|Descriptive statistic|Difference in percentages|9.5||||0.5533|TWO_SIDED|95.0|-8.7|27.8||95% CI and p-value are analyzed using a Cochran-Mantel-Haenszel (CMH) test stratified by randomization strata|Cochran-Mantel-Haenszel|||||27.8|-8.7|0.5533
72467516|NCT00551135|144458005|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3086|TWO_SIDED||||||ANOVA|||Day 7 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.3086
72467517|NCT00551135|144458005|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0406|TWO_SIDED||||||ANOVA|||Day 7 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0406
72467518|NCT00551135|144458006|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4177|TWO_SIDED||||||ANOVA|||LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.4177
72467519|NCT00551135|144458006|SUPERIORITY_OR_OTHER_LEGACY|||||||0.441|TWO_SIDED||||||ANOVA|||LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.4410
72467520|NCT00551135|144458006|SUPERIORITY_OR_OTHER_LEGACY|||||||0.556|TWO_SIDED||||||ANOVA|||LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.5560
72467521|NCT00551135|144458007|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4273|TWO_SIDED||||||ANOVA|||Total CME 3 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.4273
72467522|NCT00551135|144458007|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4466|TWO_SIDED||||||ANOVA|||Total CME 3 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.4466
72467523|NCT00551135|144458007|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3785|TWO_SIDED||||||ANOVA|||Total CME 3 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.3785
72467524|NCT00551135|144458007|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5272|TWO_SIDED||||||ANOVA|||Total CME 24 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.5272
72564752|NCT03827018|144661004|OTHER|Descriptive statistics|Difference in percentages|39.3||||0.0031|TWO_SIDED|95.0|17.2|61.3||95% CI and p-value are analyzed using a Cochran-Mantel-Haenszel (CMH) test stratified by randomization strata|Cochran-Mantel-Haenszel|||||61.3|17.2|0.0031
72564753|NCT03827018|144661005|OTHER|Descriptive statistics|Least Squares (LS) means difference|-380.82||||0.1629|TWO_SIDED|95.0|-919.66|158.02||Calculated using ANCOVA with treatment arm and randomization strata as discrete variables, and corticosteroid starting dose as a continuous variable|ANCOVA|||||158.02|-919.66|0.1629
72467525|NCT00551135|144458007|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4257|TWO_SIDED||||||ANOVA|||Total CME 24 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.4257
72467526|NCT00551135|144458007|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1428|TWO_SIDED||||||ANOVA|||Total CME 24 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.1428
72467527|NCT00551135|144458007|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2316|TWO_SIDED||||||ANOVA|||Total CME 72 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.2316
72621830|NCT00834574|144773976|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model containing factors for sequence of products, subjects within sequence, periods, and products was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|103.0||||||90.0|97.2|110.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||110|97.2|
72621831|NCT00834574|144773977|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model containing factors for sequence of products, subjects within sequence, periods, and products was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|107.0||||||90.0|101.0|114.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||114|101|
72467528|NCT00551135|144458007|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3468|TWO_SIDED||||||ANOVA|||Total CME 72 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.3468
72467529|NCT00551135|144458007|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5367|TWO_SIDED||||||ANOVA|||Total CME 72 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.5367
72467530|NCT00551135|144458007|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0549|TWO_SIDED||||||ANOVA|||Total CME EOT; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0549
72467531|NCT00551135|144458007|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1351|TWO_SIDED||||||ANOVA|||Total CME EOT; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.1351
72564754|NCT04740931|144661023|NON_INFERIORITY|If the lower bound of a two-sided 95% confidence interval (CI) for the difference in adjusted means of the two treatments (faricimab minus aflibercept) is greater than -4 letters (the non-inferiority margin), then faricimab is considered non-inferior to aflibercept.|Difference in Adjusted Means|-0.4|STANDARD_ERROR_OF_MEAN|1.04|||TWO_SIDED|95.0|-2.5|1.6|||||The treatment difference in adjusted means of change from baseline BCVA is the calculated difference of Arm A: Faricimab and Arm B: Aflibercept. MMRM adjustments are listed in the outcome measure description.|The null hypothesis, H0: μ(faricimab) - μ(aflibercept) ≤-4 letters; the alternative hypothesis, Ha: μ(faricimab) - μ(aflibercept) \>-4 letters. The final sample size provided \>90% power for the non-inferiority assessment (at a one-sided 0.02485 significance level).||1.6|-2.5|
72621832|NCT00834574|144773978|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model containing factors for sequence of products, subjects within sequence, periods, and products was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|107.0||||||90.0|101.0|114.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||114|101|
72467532|NCT00551135|144458007|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9599|TWO_SIDED||||||ANOVA|||Total CME EOT; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.9599
72467533|NCT00551135|144458007|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4273|TWO_SIDED||||||ANOVA|||CT Distinct CME 3 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.4273
72467534|NCT00551135|144458007|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4466|TWO_SIDED||||||ANOVA|||CT Distinct CME 3 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.4466
72467535|NCT00551135|144458007|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3785|TWO_SIDED||||||ANOVA|||CT Distinct CME 3 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.3785
72467536|NCT00551135|144458007|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2869|TWO_SIDED||||||ANOVA|||CT Distinct CME 24 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.2869
72467537|NCT00551135|144458007|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9905|TWO_SIDED||||||ANOVA|||CT Distinct CME 24 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.9905
72467538|NCT00551135|144458007|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9381|TWO_SIDED||||||ANOVA|||CT Distinct CME 24 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.9381
72467539|NCT00551135|144458007|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2158|TWO_SIDED||||||ANOVA|||CT Distinct CME 72 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.2158
72564755|NCT04740931|144661023|SUPERIORITY||Difference in Adjusted Means|-0.4|STANDARD_ERROR_OF_MEAN|1.04||0.6715|TWO_SIDED|95.0|-2.5|1.6||Tested at a two-sided p\<0.0497 significance level.|Mixed Model of Repeated Measures||The treatment difference in adjusted means of change from baseline BCVA is the calculated difference of Arm A: Faricimab and Arm B: Aflibercept. MMRM adjustments are listed in the outcome measure description.|The final sample size provided \>80% power for a 3.5-letter superiority assessment of faricimab over aflibercept (at a two-sided 0.0497 significance level).||1.6|-2.5|0.6715
72564756|NCT04740931|144661025|OTHER||Difference in CMH Weighted Percentage|-1.5|||||TWO_SIDED|95.0|-8.4|5.3||||||||5.3|-8.4|
72564757|NCT04740931|144661041|OTHER||Difference in Adjusted Means|-1.2|STANDARD_ERROR_OF_MEAN|0.77|||TWO_SIDED|95.0|-2.7|0.3||||||||0.3|-2.7|
72564758|NCT01043926|144661083|NON_INFERIORITY_OR_EQUIVALENCE|"AUC(0-∞) GMR = AUC(0-∞) GM for Moderate Hepatic Insufficiency Participants ÷ AUC(0-∞) GM for Healthy Participants~A 90% CI for the AUC(0-∞) GMR was computed from the ANCOVA model. As prespecified by the analysis plan, if the upper limit bound of the 90% CI for the AUC(0-∞) GMR fell below 2.00, then the hypothesis would be met and the AUC(0-∞) of suvorexant would be similar in both groups of participants. That is, if the true ratio of the GM AUC(0-∞) is no more than 2.00."|AUC(0-∞) Geometric Mean Ratio|1.03|||||TWO_SIDED|90.0|0.74|1.43|||ANCOVA|||"The geometric mean (GM) for each participant group and the corresponding 95% confidence interval (CI) were calculated for AUC(0-∞) using an analysis of covariance (ANCOVA) model.~The AUC(0-∞) geometric mean ratio (GMR) of the 2 participant groups was used to test the primary hypothesis, which was that the AUC(0-∞) of suvorexant following a single 20-mg oral dose would be similar between participants with moderate hepatic insufficiency and healthy matched control participants."||1.43|0.74|
72467540|NCT00551135|144458007|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7887|TWO_SIDED||||||ANOVA|||CT Distinct CME 72 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.7887
72467541|NCT00551135|144458007|SUPERIORITY_OR_OTHER_LEGACY|||||||0.925|TWO_SIDED||||||ANOVA|||CT Distinct CME 72 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.9250
72621833|NCT05170061|144774018|SUPERIORITY|||||||0.05||||||see above|t-test, 2 sided|paired analysis||Sequential analysis: if the first analysis (paired t-test to determine superiority of nebivolol/valsartan over valsartan ) reached p\< 0.05, the superiority of nebivolol over valsartan was tested (paired-t test); if the second comparison reached p \< 0.05, the superiority of nebivolol/valsartan over nebivolol was tested (paired-t test)||||0.05
72621834|NCT05170061|144774019|SUPERIORITY|see primary dependent variable||||||0.05|||||||t-test, 2 sided|||||||0.05
72467542|NCT00551135|144458007|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1472|TWO_SIDED||||||ANOVA|||CT Distinct CME EOT; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.1472
72621835|NCT05170061|144774020|SUPERIORITY|see primary dependent variable||||||0.05|||||||t-test, 2 sided|||see primary dependent variable||||0.05
72621836|NCT05170061|144774021|SUPERIORITY|see primary dependent variable||||||0.05|||||||t-test, 2 sided|||see primary dependent variable||||0.05
72621837|NCT05170061|144774022|SUPERIORITY|see primary dependent variable||||||0.05|||||||t-test, 2 sided|||see primary dependent variable||||0.05
72467543|NCT00551135|144458007|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5383|TWO_SIDED||||||ANOVA|||CT Distinct CME EOT; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.5383
72467544|NCT00551135|144458007|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8869|TWO_SIDED||||||ANOVA|||CT Distinct CME EOT; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.8869
72467545|NCT00551135|144458008|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4024|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Fatigue at 3 h PS;||||0.4024
72467546|NCT00551135|144458008|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9766|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Fatigue at 3 h PS;||||0.9766
72467547|NCT00551135|144458008|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9975|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Fatigue at 3 h PS;||||0.9975
72467548|NCT00551135|144458008|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9038|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Fatigue at 24 h PS;||||0.9038
72467549|NCT00551135|144458008|SUPERIORITY_OR_OTHER_LEGACY|||||||0.937|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Fatigue at 24 h PS;||||0.9370
72621838|NCT05170061|144774023|SUPERIORITY|see primary dependent variable||||||0.05|||||||t-test, 2 sided|||see primary dependent variable||||0.05
72467550|NCT00551135|144458008|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2134|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Fatigue at 24 h PS;||||0.2134
72467551|NCT00551135|144458008|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2482|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Fatigue at 72 h PS;||||0.2482
72467552|NCT00551135|144458008|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2207|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Fatigue at 72 h PS;||||0.2207
72467553|NCT00551135|144458008|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9191|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Fatigue at 72 h PS;||||0.9191
72467554|NCT00551135|144458008|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0686|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Fatigue at EOT;||||0.0686
72503957|NCT01025336|144539185|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.5|||||TWO_SIDED|95.0|0.44|0.57|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 3: Geometric mean fold rises (GMFRs) were calculated using all subjects with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.57|0.44|
72503958|NCT01025336|144539185|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.7|||||TWO_SIDED|95.0|0.6|0.85|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 4: Geometric mean fold rises (GMFRs) were calculated using all subjects with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.85|0.60|
72503959|NCT01025336|144539185|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.8|||||TWO_SIDED|95.0|0.63|0.97|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 4: Geometric mean fold rises (GMFRs) were calculated using all subjects with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.97|0.63|
72621839|NCT05170061|144774024|SUPERIORITY|see primary dependent variable||||||0.05|||||||t-test, 2 sided|||see primary dependent variable||||0.05
72467555|NCT00551135|144458008|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0746|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Fatigue at EOT;||||0.0746
72467556|NCT00551135|144458008|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0512|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Fatigue at EOT;||||0.0512
72467557|NCT00551135|144458008|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7118|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Drowsiness at 3 h PS;||||0.7118
72467558|NCT00551135|144458008|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9883|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Drowsiness at 3 h PS;||||0.9883
72467559|NCT00551135|144458008|SUPERIORITY_OR_OTHER_LEGACY|||||||0.977|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Drowsiness at 3 h PS;||||0.9770
72467560|NCT00551135|144458008|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5457|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Drowsiness at 24 h PS;||||0.5457
72467561|NCT00551135|144458008|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2579|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Drowsiness at 24 h PS;||||0.2579
72467562|NCT00551135|144458008|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1232|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Drowsiness at 24 h PS;||||0.1232
72467563|NCT00551135|144458008|SUPERIORITY_OR_OTHER_LEGACY|||||||0.288|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Drowsiness at 72 h PS;||||0.2880
72467564|NCT00551135|144458008|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0894|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Drowsiness at 72 h PS;||||0.0894
72467565|NCT00551135|144458008|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1979|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Drowsiness at 72 h PS;||||0.1979
72503960|NCT01025336|144539185|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.9|||||TWO_SIDED|95.0|0.81|1.08|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 5: Geometric mean fold rises (GMFRs) were calculated using all subjects with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||1.08|0.81|
72503961|NCT01025336|144539185|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.9|||||TWO_SIDED|95.0|0.74|0.99|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 5: Geometric mean fold rises (GMFRs) were calculated using all subjects with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.99|0.74|
72621840|NCT05170061|144774025|SUPERIORITY|see primary dependent variable||||||0.05|||||||t-test, 2 sided|||see primary dependent variable||||0.05
72621841|NCT05170061|144774026|SUPERIORITY|see primary dependent variable||||||0.05|||||||t-test, 2 sided|||see primary dependent variable||||0.05
72621842|NCT05170061|144774027|SUPERIORITY|see primary dependent variable||||||0.05|||||||t-test, 2 sided|||see primary dependent variable||||0.05
72467566|NCT00551135|144458008|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0686|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Drowsiness at EOT;||||0.0686
72467567|NCT00551135|144458008|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0746|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Drowsiness at EOT;||||0.0746
72467568|NCT00551135|144458008|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4669|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Drowsiness at EOT;||||0.4669
72467569|NCT00551135|144458008|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5533|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Inability to Concentrate at 3 h PS;||||0.5533
72467570|NCT00551135|144458008|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1611|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Inability to Concentrate at 3 h PS;||||0.1611
72467571|NCT00551135|144458008|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1611|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Inability to Concentrate at 3 h PS;||||0.1611
72467572|NCT00551135|144458008|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4793|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Inability to Concentrate at 24 h PS;||||0.4793
72394609|NCT02310568|144295794|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.29||0.502|TWO_SIDED|90.0|-0.7|0.3|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - Placebo). Week 3: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||0.3|-0.7|0.502
72467573|NCT00551135|144458008|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3533|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Inability to Concentrate at 24 h PS;||||0.3533
72467574|NCT00551135|144458008|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8852|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Inability to Concentrate at 24 h PS;||||0.8852
72467575|NCT00551135|144458008|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3173|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Inability to Concentrate at 72 h PS;||||0.3173
72467576|NCT00551135|144458008|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3173|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Inability to Concentrate at 72 h PS;||||0.3173
72467577|NCT00551135|144458008|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8864|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Inability to Concentrate at 72 h PS;||||0.8864
72467578|NCT00551135|144458008|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8084|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Inability to Concentrate at EOT;||||0.8084
72467579|NCT00551135|144458008|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3173|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Inability to Concentrate at EOT;||||0.3173
72467580|NCT00551135|144458008|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2207|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Inability to Concentrate at EOT;||||0.2207
72467581|NCT00551135|144458008|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3747|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Nausea at 3 h PS;||||0.3747
72467582|NCT00551135|144458008|SUPERIORITY_OR_OTHER_LEGACY|||||||0.145|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Nausea at 3 h PS;||||0.1450
72621843|NCT05170061|144774028|SUPERIORITY|see primary dependent variable||||||0.05|||||||t-test, 2 sided|||see primary dependent variable||||0.05
72467583|NCT00551135|144458008|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2054|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Nausea at 3 h PS;||||0.2054
72467584|NCT00551135|144458008|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4106|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Nausea at 24 h PS;||||0.4106
72467585|NCT00551135|144458008|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2199|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Nausea at 24 h PS;||||0.2199
72467586|NCT00551135|144458008|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2896|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Nausea at 24 h PS;||||0.2896
72467587|NCT00551135|144458008|SUPERIORITY_OR_OTHER_LEGACY|||||||1|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Nausea at EOT;||||1.0000
72467588|NCT00551135|144458008|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3173|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Nausea at EOT;||||0.3173
72621844|NCT05170061|144774029|SUPERIORITY|see primary dependent variable||||||0.05|||||||t-test, 2 sided|||see primary dependent variable||||0.05
72467589|NCT00551135|144458008|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3943|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Nausea at EOT;||||0.3943
72467590|NCT00551135|144458008|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1703|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Dizziness at 3 h PS;||||0.1703
72467591|NCT00551135|144458008|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0807|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Dizziness at 3 h PS;||||0.0807
72467592|NCT00551135|144458008|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7728|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Dizziness at 3 h PS;||||0.7728
72467593|NCT00551135|144458008|SUPERIORITY_OR_OTHER_LEGACY|||||||0.477|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Dizziness at 24 h PS;||||0.4770
72467594|NCT00551135|144458008|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3625|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Dizziness at 24 h PS;||||0.3625
72467595|NCT00551135|144458008|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0617|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Dizziness at 24 h PS;||||0.0617
72621845|NCT05170061|144774030|SUPERIORITY|see primary dependent variable||||||0.05|||||||t-test, 2 sided|||see primary dependent variable||||0.05
72467596|NCT00551135|144458008|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3061|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Dizziness at 72 h PS;||||0.3061
72467597|NCT00551135|144458008|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2207|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Dizziness at EOT;||||0.2207
72467598|NCT00551135|144458008|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3173|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Dizziness at EOT;||||0.3173
72467599|NCT00551135|144458008|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9191|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Constipation at 3 h PS;||||0.9191
72467600|NCT00551135|144458008|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3173|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Constipation at 3 h PS;||||0.3173
72467601|NCT00551135|144458008|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2207|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Constipation at 3 h PS;||||0.2207
72467602|NCT00551135|144458008|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6692|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Constipation at 24 h PS;||||0.6692
72467603|NCT00551135|144458008|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7793|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Constipation at 24 h PS;||||0.7793
72467604|NCT00551135|144458008|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6065|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Constipation at 24 h PS;||||0.6065
72503962|NCT01025336|144539185|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.2|||||TWO_SIDED|95.0|0.19|0.29|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 6A: Geometric mean fold rises (GMFRs) were calculated using all subjects with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.29|0.19|
72467605|NCT00551135|144458008|SUPERIORITY_OR_OTHER_LEGACY|||||||0.357|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Constipation at 72 h PS;||||0.3570
72467606|NCT00551135|144458008|SUPERIORITY_OR_OTHER_LEGACY|||||||0.969|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Constipation at 72 h PS;||||0.9690
72467607|NCT00551135|144458008|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5299|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Constipation at 72 h PS;||||0.5299
72467608|NCT00551135|144458008|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4821|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Constipation at EOT;||||0.4821
72467609|NCT00551135|144458008|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8295|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Constipation at EOT;||||0.8295
72467610|NCT00551135|144458008|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3304|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Constipation at EOT;||||0.3304
72467611|NCT00551135|144458008|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2482|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Itching at 3 h PS;||||0.2482
72621846|NCT05170061|144774031|SUPERIORITY|see primary dependent variable||||||0.05|||||||t-test, 2 sided|||see primary dependent variable||||0.05
72467612|NCT00551135|144458008|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2482|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Itching at 24 h PS;||||0.2482
72467613|NCT00551135|144458008|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2207|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Itching at 24 h PS;||||0.2207
72467614|NCT00551135|144458008|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8055|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Itching at 24 h PS;||||0.8055
72467615|NCT00551135|144458008|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9191|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Itching at 72 h PS;||||0.9191
72467616|NCT00551135|144458008|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8488|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Itching at 72 h PS;||||0.8488
72467617|NCT00551135|144458008|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2482|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Itching at 72 h PS;||||0.2482
72467618|NCT00551135|144458008|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2482|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Itching at EOT;||||0.2482
72503963|NCT01025336|144539185|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.2|||||TWO_SIDED|95.0|0.19|0.29|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations|Serotype 6A: Geometric mean fold rises (GMFRs) were calculated using all subjects with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.29|0.19|
72621847|NCT05170061|144774032|SUPERIORITY|see primary dependent variable||||||0.05|||||||t-test, 2 sided|||see primary dependent variable||||0.05
72467619|NCT00551135|144458008|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2207|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Itching at EOT;||||0.2207
72467620|NCT00551135|144458008|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2482|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Itching at EOT;||||0.2482
72467621|NCT00551135|144458008|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3291|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Difficulty Urinating at 3 h PS;||||0.3291
72467622|NCT00551135|144458008|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1391|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Difficulty Urinating at 3 h PS;||||0.1391
72467623|NCT00551135|144458008|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6318|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Difficulty Urinating at 3 h PS;||||0.6318
72467624|NCT00551135|144458008|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6319|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Difficulty Urinating at 24 h PS;||||0.6319
72467625|NCT00551135|144458008|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8149|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Difficulty Urinating at 24 h PS;||||0.8149
72467626|NCT00551135|144458008|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5795|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Difficulty Urinating at 24 h PS;||||0.5795
72467627|NCT00551135|144458008|SUPERIORITY_OR_OTHER_LEGACY|||||||0.175|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Difficulty Urinating at 72 h PS;||||0.1750
72467628|NCT00551135|144458008|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0676|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Difficulty Urinating at 72 h PS;||||0.0676
72467629|NCT00551135|144458008|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2943|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Difficulty Urinating at EOT;||||0.2943
72467630|NCT00551135|144458008|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0719|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Difficulty Urinating at EOT;||||0.0719
72621848|NCT05170061|144774033|SUPERIORITY|see primary dependent variable||||||0.05|||||||t-test, 2 sided|||see primary dependent variable||||0.05
72467631|NCT00551135|144458008|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9283|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Confusion at 3 h PS;||||0.9283
72467632|NCT00551135|144458008|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9024|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Confusion at 3 h PS;||||0.9024
72467633|NCT00551135|144458008|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7655|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Confusion at 3 h PS;||||0.7655
72621849|NCT05170061|144774034|SUPERIORITY|see primary dependent variable||||||0.05|||||||t-test, 2 sided|||see primary dependent variable||||0.05
72621850|NCT05170061|144774035|SUPERIORITY|||||||0.05|||||||t-test, 2 sided|||see primary dependent variable||||0.05
72467634|NCT00551135|144458008|SUPERIORITY_OR_OTHER_LEGACY|||||||1|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Confusion at 24 h PS;||||1.0000
72467635|NCT00551135|144458008|SUPERIORITY_OR_OTHER_LEGACY|||||||0.846|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Confusion at 24 h PS;||||0.8460
72503964|NCT01025336|144539185|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.4|||||TWO_SIDED|95.0|0.31|0.45|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 6B: Geometric mean fold rises (GMFRs) were calculated using all subjects with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.45|0.31|
72503965|NCT01025336|144539185|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.5|||||TWO_SIDED|95.0|0.4|0.59|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 6B: Geometric mean fold rises (GMFRs) were calculated using all subjects with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.59|0.40|
72503966|NCT01025336|144539185|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.7|||||TWO_SIDED|95.0|0.58|0.96|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations|Serotype 7F: Geometric mean fold rises (GMFRs) were calculated using all subjects with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.96|0.58|
72503967|NCT01025336|144539185|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.9|||||TWO_SIDED|95.0|0.67|1.13|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 7F: Geometric mean fold rises (GMFRs) were calculated using all subjects with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||1.13|0.67|
72503968|NCT01025336|144539185|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.5|||||TWO_SIDED|95.0|0.37|0.67|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 9V: Geometric mean fold rises (GMFRs) were calculated using all subjects with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.67|0.37|
72503969|NCT01025336|144539185|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.8|||||TWO_SIDED|95.0|0.57|1.12|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 9V: Geometric mean fold rises (GMFRs) were calculated using all subjects with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||1.12|0.57|
72503970|NCT01025336|144539185|SUPERIORITY_OR_OTHER||Geometric mean fold rise|1.0|||||TWO_SIDED|95.0|0.85|1.09|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 14: Geometric mean fold rises (GMFRs) were calculated using all subjects with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||1.09|0.85|
72621851|NCT05170061|144774036|SUPERIORITY|see primary dependent variable||||||0.05|||||||t-test, 2 sided|||see primary dependent variable||||0.05
72621852|NCT05170061|144774037|SUPERIORITY|see primary dependent variable||||||0.05|||||||t-test, 2 sided|||see primary dependent variable||||0.05
72467636|NCT00551135|144458008|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6419|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Confusion at 24 h PS;||||0.6419
72467637|NCT00551135|144458008|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9522|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Confusion at 72 h PS;||||0.9522
72467638|NCT00551135|144458008|SUPERIORITY_OR_OTHER_LEGACY|||||||0.58|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Confusion at 72 h PS;||||0.5800
72467639|NCT00551135|144458008|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7675|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Confusion at 72 h PS;||||0.7675
72467640|NCT00551135|144458008|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1672|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Confusion at EOT;||||0.1672
72503971|NCT01025336|144539185|SUPERIORITY_OR_OTHER||Geometric mean fold rise|1.2|||||TWO_SIDED|95.0|1.04|1.43|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 14: Geometric mean fold rises (GMFRs) were calculated using all subjects with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||1.43|1.04|
72503972|NCT01025336|144539185|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.5|||||TWO_SIDED|95.0|0.48|0.62|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 18C: Geometric mean fold rises (GMFRs) were calculated using all subjects with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.62|0.48|
72503973|NCT01025336|144539185|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.7|||||TWO_SIDED|95.0|0.59|0.83|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 18C: Geometric mean fold rises (GMFRs) were calculated using all subjects with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.83|0.59|
72621853|NCT05170061|144774038|SUPERIORITY|see primary dependent variable||||||0.05|||||||t-test, 2 sided|||see primary dependent variable||||0.05
72621854|NCT05170061|144774039|SUPERIORITY|see primary dependent variable||||||0.05|||||||t-test, 2 sided|||see primary dependent variable||||0.05
72467641|NCT00551135|144458008|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9634|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Confusion at EOT;||||0.9634
72467642|NCT00551135|144458008|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1161|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Confusion at EOT;||||0.1161
72467643|NCT00551135|144458008|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0754|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Retching/Vomiting at 3 h PS;||||0.0754
72467644|NCT00551135|144458008|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0711|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Retching/Vomiting at 3 h PS;||||0.0711
72503974|NCT01025336|144539185|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.6|||||TWO_SIDED|95.0|0.57|0.72|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 19A: Geometric mean fold rises (GMFRs) were calculated using all subjects with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.72|0.57|
72503975|NCT01025336|144539185|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.7|||||TWO_SIDED|95.0|0.65|0.79|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 19A: Geometric mean fold rises (GMFRs) were calculated using all subjects with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.79|0.65|
72503976|NCT01025336|144539185|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.8|||||TWO_SIDED|95.0|0.66|0.93|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 19F: Geometric mean fold rises (GMFRs) were calculated using all subjects with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.93|0.66|
72621855|NCT00530257|144774044|SUPERIORITY_OR_OTHER||||||<|0.01||95.0||||We used a Bonferroni correct to adjust for up to 5 measures across domains and use a p-value of \<=0.01. With a sample of 30 subjects the analytic model was able to detect a difference of large effect size (Cohen's d= \>0.655)|Wilcoxon (Mann-Whitney)|||We evaluated the data for cross over effects. No statistical significant sequence effect were seen for our endpoints and hence we combined the data from both periods of the crossover design There was evidence against the assumption of normality for performance on some of the measures of attention. Thus we used the non-parametric Wilcoxon Signed Ranks Test to compare performance on OROS-methylphenidate versus placebo.||||<0.01
72467645|NCT00551135|144458008|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0711|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Retching/Vomiting at 3 h PS;||||0.0711
72467646|NCT00551135|144458008|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2482|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Retching/Vomiting at 24 h PS;||||0.2482
72467647|NCT00551135|144458008|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8091|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Retching/Vomiting at 24 h PS;||||0.8091
72503977|NCT01025336|144539185|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.9|||||TWO_SIDED|95.0|0.75|1.05|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 19F: Geometric mean fold rises (GMFRs) were calculated using all subjects with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||1.05|0.75|
72467648|NCT00551135|144458008|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2482|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Retching/Vomiting at 24 h PS;||||0.2482
72467649|NCT00551135|144458008|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3173|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Retching/Vomiting at EOT;||||0.3173
72467650|NCT00551135|144458008|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3173|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Retching/Vomiting at EOT;||||0.3173
72467651|NCT00551135|144458008|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4386|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Retching/Vomiting at EOT;||||0.4386
72467652|NCT00551135|144458009|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1723|TWO_SIDED|||||P-values derived from Cochran-Mantel-Haenszel (CMH) test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||24 h PS.||||0.1723
72467653|NCT00551135|144458009|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0639|TWO_SIDED|||||P-values derived from Cochran-Mantel-Haenszel (CMH) test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||24 h PS||||0.0639
72503978|NCT01025336|144539185|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.3|||||TWO_SIDED|95.0|0.27|0.37|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations|Serotype 23F: Geometric mean fold rises (GMFRs) were calculated using all subjects with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.37|0.27|
72621856|NCT00530257|144774045|SUPERIORITY_OR_OTHER||||||<|0.01||95.0||||Same as described for TEA-Ch Walk, Don't Walk|Wilcoxon (Mann-Whitney)|||Same as described for TEA-Ch Walk, Don't Walk||||<0.01
72564759|NCT01043926|144661084|NON_INFERIORITY_OR_EQUIVALENCE|"Cmax GMR = Cmax GM for Moderate Hepatic Insufficiency Participants ÷ Cmax GM for Healthy Participants~A 90% CI for the Cmax GMR was computed from the ANCOVA model. As prespecified by the analysis plan, if the upper limit bound of the 90% CI for the Cmax GMR fell below 2.00, then the hypothesis would be met and the Cmax of suvorexant would be similar in both groups of participants. That is, if the true ratio of the geometric mean Cmax is no more than 2.00."|Cmax Geometric Mean Ratio|0.94|||||TWO_SIDED|90.0|0.68|1.29|||ANCOVA|||"The GM for each participant group and the corresponding 95% CI were calculated for Cmax using an ANCOVA model.~The Cmax GMR of the 2 participant groups was used to test the primary hypothesis, which was that the Cmax of suvorexant following a single 20-mg oral dose would be similar between participants with moderate hepatic insufficiency and healthy matched control participants."||1.29|0.68|
72564760|NCT01192399|144661102|OTHER||||||<|0.0001|||||||Sign test|||||||<0.0001
72621857|NCT00530257|144774046|SUPERIORITY_OR_OTHER||||||<|0.05||95.0||||This p value is not adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|||We evaluated the data for cross over effects. No statistical significant sequence effect were seen for our endpoints and hence we combined the data from both periods of the crossover design There was evidence against the assumption of normality for performance on some of the measures of attention. Thus we used the non-parametric Wilcoxon Signed Ranks Test to compare performance on OROS-methylphenidate versus placebo.||||<0.05
72467654|NCT00551135|144458009|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0021|TWO_SIDED|||||P-values derived from Cochran-Mantel-Haenszel (CMH) test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||24 h PS.||||0.0021
72467655|NCT00551135|144458009|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1127|TWO_SIDED|||||P-values derived from Cochran-Mantel-Haenszel (CMH) test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||EOT.||||0.1127
72467656|NCT00551135|144458009|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0703|TWO_SIDED|||||P-values derived from Cochran-Mantel-Haenszel (CMH) test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||EOT.||||0.0703
72467657|NCT00551135|144458009|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0012|TWO_SIDED|||||P-values derived from Cochran-Mantel-Haenszel (CMH) test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||EOT.||||0.0012
72467658|NCT00551135|144458011|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1927|TWO_SIDED|||||P-values derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjests have been combined into pooled centers.|Cochran-Mantel-Haenszel|||24 h PS.||||0.1927
72621858|NCT00530257|144774048|SUPERIORITY_OR_OTHER||||||<|0.05||95.0||||We did not correct for multiple comparisons|t-test, 2 sided|We used a paired t-test||A paired t-test was used to compare the medication versus placebo.||||<0.05
72467659|NCT00551135|144458011|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3865|TWO_SIDED|||||P-values derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjests have been combined into pooled centers.|Cochran-Mantel-Haenszel|||72 h PS||||0.3865
72467660|NCT00551135|144458011|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9869|TWO_SIDED|||||P-values derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjests have been combined into pooled centers.|Cochran-Mantel-Haenszel|||72 h PS.||||0.9869
72467661|NCT00551135|144458011|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4354|TWO_SIDED|||||P-values derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjests have been combined into pooled centers.|Cochran-Mantel-Haenszel|||72 h PS.||||0.4354
72564761|NCT00063882|144661111|SUPERIORITY||Cox Proportional Hazard|0.82||||0.21|TWO_SIDED|95.0|0.6|1.12||One-sided significance level of 0.025|Greenwood's T||Reference level = Brachytherapy only|Target sample size was 586; 532 patients were needed to test hypothesis of better FFP in the EBRT + Brachytherapy arm over the Brachytherapy Only arm. The trial is designed to detect a 10% improvement in 5-year FFP with 90% power, 1-sided alpha of 0.025. The Z-test statistic for the difference between the 2 5-year FFP rates with the standard errors estimated by Greenwood's method will be used.||1.12|0.60|0.21
72564762|NCT00063882|144661112|SUPERIORITY||Hazard Ratio (HR)|0.99||||0.95|TWO_SIDED|95.0|0.63|1.54||One-sided significance level of 0.025|Log Rank||Reference level = Brachytherapy Only|||1.54|0.63|0.95
72467662|NCT00551135|144458011|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8061|TWO_SIDED|||||P-values derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjests have been combined into pooled centers.|Cochran-Mantel-Haenszel|||72 h PS.||||0.8061
72467663|NCT00551135|144458012|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1682|TWO_SIDED||||||ANOVA|||Baseline; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.1682
72467664|NCT00551135|144458012|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2821|TWO_SIDED||||||ANOVA|||Baseline; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.2821
72467665|NCT00551135|144458012|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4781|TWO_SIDED||||||ANOVA|||Baseline; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.4781
72467666|NCT00551135|144458012|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0557|TWO_SIDED||||||ANOVA|||2 h BS; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0557
72467667|NCT00551135|144458012|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6098|TWO_SIDED||||||ANOVA|||2 h BS; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.6098
72467668|NCT00551135|144458012|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1821|TWO_SIDED||||||ANOVA|||2 h BS; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.1821
72467669|NCT00551135|144458012|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1628|TWO_SIDED||||||ANOVA|||1 h PS; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.1628
72467670|NCT00551135|144458012|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8999|TWO_SIDED||||||ANOVA|||1 h PS; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.8999
72467671|NCT00551135|144458012|SUPERIORITY_OR_OTHER_LEGACY|||||||0.399|TWO_SIDED||||||ANOVA|||1 h PS; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.3990
72564763|NCT00063882|144661113|SUPERIORITY||Hazard Ratio (HR)|1.0||||0.97|TWO_SIDED|95.0|0.64|1.58||One-sided significance level of 0.025|Log Rank||Reference level = Brachytherapy Only|||1.58|0.64|0.97
72467672|NCT00551135|144458012|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2665|TWO_SIDED||||||ANOVA|||2 h PS; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.2665
72467673|NCT00551135|144458012|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4885|TWO_SIDED||||||ANOVA|||2 h PS; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.4885
72467674|NCT00551135|144458012|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6415|TWO_SIDED||||||ANOVA|||2 h PS; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.6415
72621859|NCT00530257|144774050|SUPERIORITY_OR_OTHER||||||<|0.01||95.0||||Same as described for TEA-Ch: Walk, Don't Walk.|Wilcoxon (Mann-Whitney)|||Same as described for TEA-Ch: Walk, Don't Walk||||<0.01
72621860|NCT00530257|144774051|SUPERIORITY_OR_OTHER||||||<|0.01||95.0||||The p value adjusts for multiple comparisons|Wilcoxon (Mann-Whitney)|||||||<0.01
72621861|NCT00530257|144774052|SUPERIORITY_OR_OTHER||||||<|0.01||95.0||||Same as described for TEA-Ch: Walk, Don't Walk|Wilcoxon (Mann-Whitney)|||Same as described for TEA-Ch: Walk, Don't Walk||||<0.01
72467675|NCT00551135|144458012|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2269|TWO_SIDED||||||ANOVA|||3 h PS; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.2269
72467676|NCT00551135|144458012|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3228|TWO_SIDED||||||ANOVA|||3 h PS; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.3228
72467677|NCT00551135|144458012|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1808|TWO_SIDED||||||ANOVA|||3 h PS; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.1808
72467678|NCT00551135|144458012|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3282|TWO_SIDED||||||ANOVA|||Day 2 PS; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.3282
72467679|NCT00551135|144458012|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0342|TWO_SIDED||||||ANOVA|||Day 2 PS; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0342
72467680|NCT00551135|144458012|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4198|TWO_SIDED||||||ANOVA|||Day 2 PS; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.4198
72467681|NCT00551135|144458012|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9049|TWO_SIDED||||||ANOVA|||Day 3 PS; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.9049
72564764|NCT00063882|144661114|SUPERIORITY||Hazard Ratio (HR)|1.19||||0.77|TWO_SIDED|95.0|0.36|3.9||One-sided significance level of 0.025|Log Rank||Reference level = Brachytherapy Only|||3.90|0.36|0.77
72564765|NCT00063882|144661115|SUPERIORITY||Hazard Ratio (HR)|1.01||||0.99|TWO_SIDED|95.0|0.33|3.13||One-sided significance level of 0.025|Log Rank||Reference level = Brachytherapy Only|||3.13|0.33|0.99
72564766|NCT00063882|144661116|SUPERIORITY||Hazard Ratio (HR)|1.12||||0.81|TWO_SIDED|95.0|0.46|2.76||One-sided significance level of 0.025|Log Rank||Reference level = Brachytherapy Only|||2.76|0.46|0.81
72621862|NCT00530257|144774053|SUPERIORITY_OR_OTHER||||||<|0.01||95.0||||Same as described for TEA-Ch: Walk, Don't Walk|Wilcoxon (Mann-Whitney)|||Same as described for TEA-Ch: Walk, Don't Walk||||<0.01
72621863|NCT00530257|144774054|SUPERIORITY_OR_OTHER||||||<|0.01||95.0||||Same as described for TEA-Ch: Walk, Don't Walk|Wilcoxon (Mann-Whitney)|||Same as described for TEA-Ch: Walk, Don't Walk||||<0.01
72621864|NCT00530257|144774055|SUPERIORITY_OR_OTHER||||||<|0.01||95.0||||Same as described for TEA-Ch: Walk, Don't Walk|Wilcoxon (Mann-Whitney)|||Same as described for TEA-Ch: Walk, Don't Walk||||<0.01
72564767|NCT00063882|144661117|SUPERIORITY||Hazard Ratio (HR)|0.77||||0.22|TWO_SIDED|95.0|0.51|1.17||One-sided significance level of 0.025|Log Rank||Reference level = Brachytherapy Only|||1.17|0.51|0.22
72467682|NCT00551135|144458012|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0456|TWO_SIDED||||||ANOVA|||Day 3 PS; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0456
72564768|NCT00063882|144661118|SUPERIORITY||Odds Ratio (OR)|1.13||||0.53|TWO_SIDED|95.0|0.76|1.67||One-sided significance level of 0.05|Chi-squared||Reference level = Brachytherapy Only|Grade 2+ GU/GI||1.67|0.76|0.53
72564769|NCT00063882|144661118|SUPERIORITY||Odds Ratio (OR)|1.06||||0.73|TWO_SIDED|95.0|0.73|1.53||One-sided significance level of 0.05|Chi-squared||Reference level = Brachytherapy Only|Grade 2+ Overall||1.53|0.73|0.73
72564770|NCT00063882|144661118|SUPERIORITY||Odds Ratio (OR)|1.09||||0.81|TWO_SIDED|95.0|0.54|2.19||One-sided significance level of 0.05|Chi-squared||Reference level = Brachytherapy Only|Grade 3+ GU/GI||2.19|0.54|0.81
72467683|NCT00551135|144458012|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2463|TWO_SIDED||||||ANOVA|||Day 3 PS; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.2463
72621865|NCT02579759|144774070|SUPERIORITY||Mean Difference (Final Values)|-0.37|STANDARD_ERROR_OF_MEAN|0.14||0.008|TWO_SIDED|97.5|-0.68|-0.06|||ANCOVA|||"The main analysis was performed as follows:~1. Analysis population: modified Full Analysis Set (mFAS)~2. Statistical model: ANCOVA where the mean at 12 and 15 months of each treatment group was compared against the placebo group, adjusting for the baseline value and assuming centre as a random effect~3. Missing value imputation: multiple imputation taking into account the reason of missingness"||-0.06|-0.68|0.008
72621866|NCT02579759|144774070|SUPERIORITY||Mean Difference (Final Values)|-0.13|STANDARD_ERROR_OF_MEAN|0.12||0.287|TWO_SIDED|97.5|-0.39|0.14|||ANCOVA|||"The main analysis was performed as follows:~1. Analysis population: modified Full Analysis Set (mFAS)~2. Statistical model: ANCOVA where the mean at 12 and 15 months of each treatment group was compared against the placebo group, adjusting for the baseline value and assuming centre as a random effect~3. Missing value imputation: multiple imputation taking into account the reason of missingness"||0.14|-0.39|0.287
72394610|NCT02310568|144295794|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|0.29||0.348|TWO_SIDED|90.0|-0.2|0.7|||Mixed-Effects Model Repeated Measure|||(PF-06372865 2.5 mg - Placebo). Week 3: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||0.7|-0.2|0.348
72467684|NCT00551135|144458012|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8231|TWO_SIDED||||||ANOVA|||Day 4 PS; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.8231
72394611|NCT02310568|144295794|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.33||0.16|TWO_SIDED|90.0|-1.0|0.1|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 3: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||0.1|-1.0|0.160
72467685|NCT00551135|144458012|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0221|TWO_SIDED||||||ANOVA|||Day 4 PS; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0221
72564771|NCT00063882|144661118|SUPERIORITY||Odds Ratio (OR)|0.93||||0.82|TWO_SIDED|95.0|0.51|1.69||One-sided significance level of 0.05|Chi-squared||Reference level = Brachytherapy Only|Grade 3+ Overall||1.69|0.51|0.82
72564772|NCT00063882|144661119|SUPERIORITY||Hazard Ratio (HR)|2.37||||0.01|TWO_SIDED|95.0|1.2|4.68||One-sided significance level of 0.025|Log Rank||Reference level = Brachytherapy Only|Grade 3+ GU/GI||4.68|1.20|0.01
72564773|NCT00063882|144661119|SUPERIORITY||Hazard Ratio (HR)|1.81||||0.029|TWO_SIDED|95.0|1.06|3.1||One-sided significance level of 0.025|Log Rank||Reference level = Brachytherapy Only|Grade 3+ Overall||3.10|1.06|0.029
72564774|NCT00063882|144661120|SUPERIORITY||Effect size|0.4|||<|0.0001|TWO_SIDED|||||Significance level of 0.01|t-test, 2 sided||Minimally important difference (MID) defined as an effect size of at least 0.5. Effect sizes are interpreted as negligible: \< 0.3; small: 0.3 to \< 0.5; moderate: 0.5 to \< 0.7; and large ≥ 0.7.|Urinary||||<0.0001
72564775|NCT00063882|144661120|SUPERIORITY||Effect size|0.09||||0.33|TWO_SIDED|||||significance level of 0.01|t-test, 2 sided||Minimally important difference (MID) defined as an effect size of at least 0.5. Effect sizes are interpreted as negligible: \< 0.3; small: 0.3 to \< 0.5; moderate: 0.5 to \< 0.7; and large ≥ 0.7.|Urinary- Incontinence||||0.33
72467686|NCT00551135|144458012|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6974|TWO_SIDED||||||ANOVA|||Day 4 PS; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.6974
72467687|NCT00551135|144458012|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7461|TWO_SIDED||||||ANOVA|||Day 5 PS; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.7461
72564776|NCT00063882|144661120|SUPERIORITY||Effect size|0.44|||<|0.0001|TWO_SIDED|||||significance level of 0.01|t-test, 2 sided||Minimally important difference (MID) defined as an effect size of at least 0.5. Effect sizes are interpreted as negligible: \< 0.3; small: 0.3 to \< 0.5; moderate: 0.5 to \< 0.7; and large ≥ 0.7.|Urinary-Irritative||||<0.0001
72564777|NCT00063882|144661120|SUPERIORITY||Effect size|0.31||||0.001|TWO_SIDED|||||significance level of 0.01|t-test, 2 sided||Minimally important difference (MID) defined as an effect size of at least 0.5. Effect sizes are interpreted as negligible: \< 0.3; small: 0.3 to \< 0.5; moderate: 0.5 to \< 0.7; and large ≥ 0.7.|Bowel||||0.001
72467688|NCT00551135|144458012|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1198|TWO_SIDED||||||ANOVA|||Day 5 PS; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.1198
72467689|NCT00551135|144458012|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8031|TWO_SIDED||||||ANOVA|||Day 5 PS; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.8031
72467690|NCT00551135|144458012|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8515|TWO_SIDED||||||ANOVA|||Day 6 PS; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.8515
72467691|NCT00551135|144458012|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1285|TWO_SIDED||||||ANOVA|||Day 6 PS; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.1285
72467692|NCT00551135|144458012|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5561|TWO_SIDED||||||ANOVA|||Day 6 PS; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.5561
72467693|NCT00551135|144458012|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6858|TWO_SIDED||||||ANOVA|||Day 7 PS; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.6858
72564778|NCT00063882|144661120|SUPERIORITY||Effect size|0.12||||0.23|TWO_SIDED||||||t-test, 2 sided|||Sexual|Minimally important difference (MID) defined as an effect size of at least 0.5. Effect sizes are interpreted as negligible: \< 0.3; small: 0.3 to \< 0.5; moderate: 0.5 to \< 0.7; and large ≥ 0.7.|||0.23
72467694|NCT00551135|144458012|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0693|TWO_SIDED||||||ANOVA|||Day 7 PS; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0693
72467695|NCT00551135|144458012|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5547|TWO_SIDED||||||ANOVA|||Day 7 PS; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.5547
72467696|NCT00551135|144458012|SUPERIORITY_OR_OTHER_LEGACY|||||||0.461|TWO_SIDED||||||ANOVA|||Day 8 PS; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.4610
72467697|NCT00551135|144458012|SUPERIORITY_OR_OTHER_LEGACY|||||||0.664|TWO_SIDED||||||ANOVA|||Day 8 PS; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.6640
72564779|NCT00063882|144661121|SUPERIORITY||Effect size|0.38||||0.0002|TWO_SIDED|||||Significance level of 0.01|t-test, 2 sided||Minimally important difference (MID) defined as an effect size of at least 0.5. Effect sizes are interpreted as negligible: \< 0.3; small: 0.3 to \< 0.5; moderate: 0.5 to \< 0.7; and large ≥ 0.7.|Urinary||||0.0002
72467698|NCT00551135|144458012|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6158|TWO_SIDED||||||ANOVA|||Day 8 PS; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.6158
72467699|NCT00551135|144458012|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1632|TWO_SIDED||||||ANOVA|||Day 9 PS; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.1632
72467700|NCT00551135|144458012|SUPERIORITY_OR_OTHER_LEGACY|||||||0.177|TWO_SIDED||||||ANOVA|||Day 9 PS; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.1770
72467701|NCT00551135|144458012|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4882|TWO_SIDED||||||ANOVA|||Day 9 PS; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.4882
72467702|NCT00551135|144458013|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7936|TWO_SIDED||||||ANOVA|||Baseline; LS Means from ANOVA model with terms of treatment, pooled center, baseline item score and basline PCS (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.7936
72564780|NCT00063882|144661121|SUPERIORITY||Effect size|0.08||||0.42|TWO_SIDED|||||Significance level of 0.01|t-test, 2 sided||Minimally important difference (MID) defined as an effect size of at least 0.5. Effect sizes are interpreted as negligible: \< 0.3; small: 0.3 to \< 0.5; moderate: 0.5 to \< 0.7; and large ≥ 0.7.|Urinary-Incontinence||||0.42
72564781|NCT00063882|144661121|SUPERIORITY||Effect size|0.44|||<|0.0001|TWO_SIDED|||||Significance level of 0.01|t-test, 2 sided||Minimally important difference (MID) defined as an effect size of at least 0.5. Effect sizes are interpreted as negligible: \< 0.3; small: 0.3 to \< 0.5; moderate: 0.5 to \< 0.7; and large ≥ 0.7.|Urinary-Irritative||||<0.0001
72564782|NCT00063882|144661121|SUPERIORITY||Effect size|0.42|||<|0.0001|TWO_SIDED|||||Significance level of 0.01|t-test, 2 sided||Minimally important difference (MID) defined as an effect size of at least 0.5. Effect sizes are interpreted as negligible: \< 0.3; small: 0.3 to \< 0.5; moderate: 0.5 to \< 0.7; and large ≥ 0.7.|Bowel||||<0.0001
72467703|NCT00551135|144458013|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5092|TWO_SIDED||||||ANOVA|||Baseline; LS Means from ANOVA model with terms of treatment, pooled center, baseline item score and basline PCS (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.5092
72564783|NCT00063882|144661121|SUPERIORITY||Effect size|0.27||||0.0072|TWO_SIDED|||||Significance level of 0.01|t-test, 2 sided||Minimally important difference (MID) defined as an effect size of at least 0.5. Effect sizes are interpreted as negligible: \< 0.3; small: 0.3 to \< 0.5; moderate: 0.5 to \< 0.7; and large ≥ 0.7.|Sexual||||0.0072
72564784|NCT01103479|144661127|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.65||||0.32|TWO_SIDED|95.0|0.62|4.38||Random effects model adjusting for clustering by clinic|Mixed Models Analysis|||||4.38|0.62|0.32
72564785|NCT01103479|144661128|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.8||||0.28|TWO_SIDED|95.0|0.53|1.2||Linear model adjusting for stratification by clinic and participant age|Mixed Models Analysis|||||1.20|0.53|0.28
72564786|NCT01103479|144661129|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.43||||0.42|TWO_SIDED|95.0|0.6|3.43||Random effects model adjusted for clustering by clinic|Mixed Models Analysis|||||3.43|0.60|0.42
72564787|NCT01103479|144661130|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.05||||0.38|TWO_SIDED|95.0|0.94|1.18||Linear model adjusting for stratification by clinic and participant age|Mixed Models Analysis|||||1.18|0.94|0.38
72564788|NCT00605917|144661136|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||not adjusted, p=0.050|Chi-squared|||"The risk factor tested was starting dose. The null hypothesis is there is no difference between three types of starting dose in the participants of responders."||||<0.001
72564789|NCT00605917|144661137|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002|TWO_SIDED|||||not adjusted, p=0.050|Chi-squared|||"The risk factor tested was concomitant drug. The null hypothesis is there is no difference between with and without concomitant drug in the participants of responders."||||0.002
72564790|NCT00605917|144661138|SUPERIORITY_OR_OTHER_LEGACY|||||||0.032|TWO_SIDED|||||not adjusted, p=0.050|Chi-squared|||"The risk factor tested was family history of psychiatric disorder. The null hypothesis is there is no difference between with and without family history of psychiatric disorder in the participants of responders."||||0.032
72621867|NCT02579759|144774070|SUPERIORITY||Mean Difference (Final Values)|-0.31|STANDARD_ERROR_OF_MEAN|0.13||0.013|TWO_SIDED|97.5|-0.59|-0.03|||Longitudinal mixed model|||"This analysis was performed as follows:~1. Analysis population: modified Full Analysis Set (mFAS)~2. Statistical model: Longitudinal model where the effect of each treatment over time (baseline, 6, 12 and 15 months) was estimated through a mixed model with repeated measures (MMRM) assuming time from baseline (Time) and Time-by-Treatment full interaction as fixed effects and patient as random effect and considering Time as continuous linear effect~3. Missing value imputation: No imputation"||-0.03|-0.59|0.013
72621868|NCT02579759|144774070|SUPERIORITY||Mean Difference (Final Values)|-0.19|STANDARD_ERROR_OF_MEAN|0.1||0.05|TWO_SIDED|97.5|-0.42|0.03|||Longitudinal mixed model|||"This analysis was performed as follows:~1. Analysis population: modified Full Analysis Set (mFAS)~2. Statistical model: Longitudinal model where the effect of each treatment over time (baseline, 6, 12 and 15 months) was estimated through a mixed model with repeated measures (MMRM) assuming time from baseline (Time) and Time-by-Treatment full interaction as fixed effects and patient as random effect and considering Time as continuous linear effect~3. Missing value imputation: No imputation"||0.03|-0.42|0.05
72467704|NCT00551135|144458013|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4233|TWO_SIDED||||||ANOVA|||Baseline; LS Means from ANOVA model with terms of treatment, pooled center, baseline item score and basline PCS (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.4233
72564791|NCT00605917|144661139|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||not adjusted, p=0.050|Chi-squared|||"The risk factor tested was smoking status. The null hypothesis is there is no difference between three types of smoking status in the participants of responders."||||<0.001
72564792|NCT00605917|144661140|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||not adjusted, p=0.050|Chi-squared|||"The risk factor tested was past medical history of other illness. The null hypothesis is there is no difference between with and without past medical history of other illness in the participants of responders."||||<0.001
72564793|NCT00605917|144661141|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|TWO_SIDED|||||not adjusted, p=0.050|Chi-squared|||"The risk factor tested was non-pharmaceutical therapies. The null hypothesis is there is no difference between with and without non-pharmaceutical therapies in the participants of responders."||||0.001
72564794|NCT00605917|144661142|SUPERIORITY_OR_OTHER_LEGACY|||||||0.028|TWO_SIDED|||||not adjusted, p=0.050|Chi-squared|||"The risk factor tested was history of treatment prior to administration of Sertraline. The null hypothesis is there is no difference between with and without history of treatment prior to administration of Sertraline in the participants of responders."||||0.028
72564795|NCT00605917|144661143|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||not adjusted, p=0.050|Chi-squared|||"The risk factor tested was average daily dose. The null hypothesis is there is no difference of five types of average daily dose in the participants of responders."||||<0.001
72564796|NCT00605917|144661144|SUPERIORITY_OR_OTHER_LEGACY|||||||0.03|TWO_SIDED|||||"The risk factor tested was complications. The null hypothesis is there is no difference between with and without complications in the participants of responders."|Chi-squared|not adjusted, p=0.050||"The risk factor tested was complications. The null hypothesis is there is no difference between with and without complications in the participants of responders."||||0.030
72564797|NCT00605917|144661145|SUPERIORITY_OR_OTHER_LEGACY|||||||0.013|TWO_SIDED|||||not adjusted, p=0.050|Chi-squared|||"The factor tested was concomitant drug. The null hypothesis is there is no difference between with and without concomitant drug in the participants of responders."||||0.013
72564798|NCT00605917|144661146|SUPERIORITY_OR_OTHER_LEGACY|||||||0.004|TWO_SIDED|||||not adjusted, p=0.050|Chi-squared|||"The factor tested was complications. The null hypothesis is there is no difference between with or without complications in the participants of responders."||||0.004
72564799|NCT00605917|144661147|SUPERIORITY_OR_OTHER_LEGACY|||||||0.004|TWO_SIDED|||||not adjusted, p=0.050|Chi-squared|||"The factor tested was drinking status. The null hypothesis is there is no difference between five types of drinking status in the participants of responders."||||0.004
72564800|NCT02443545|144661159|OTHER|One-sample t-test, to determine whether the change from baseline in LIC was significantly different from 0.||||||0|||||||t-test, 2 sided|||Change from baseline after 1 year of deferiprone therapy||||0.0000
72467705|NCT00551135|144458013|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2033|TWO_SIDED||||||ANOVA|||Change at EOT; LS Means from ANOVA model with terms of treatment, pooled center, baseline item score and basline PCS (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.2033
72467706|NCT00551135|144458013|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2142|TWO_SIDED||||||ANOVA|||Change at EOT; LS Means from ANOVA model with terms of treatment, pooled center, baseline item score and basline PCS (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.2142
72467707|NCT00551135|144458013|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1218|TWO_SIDED||||||ANOVA|||Change at EOT; LS Means from ANOVA model with terms of treatment, pooled center, baseline item score and basline PCS (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.1218
72467708|NCT00551135|144458014|SUPERIORITY_OR_OTHER_LEGACY|||||||0.083|TWO_SIDED||||||ANOVA|||Total score change at 3 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0830
72467709|NCT00551135|144458014|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2339|TWO_SIDED||||||ANOVA|||Total score change at 3 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.2339
72503979|NCT01025336|144539185|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.4|||||TWO_SIDED|95.0|0.34|0.48|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 23F: Geometric mean fold rises (GMFRs) were calculated using all subjects with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.48|0.34|
72564801|NCT02443545|144661159|OTHER|One-sample t-test, to determine whether the change from baseline in LIC was significantly different from 0.||||||0|||||||t-test, 2 sided|||Change from baseline after 2 years of deferiprone therapy||||0.0000
72564802|NCT02443545|144661159|OTHER|One-sample t-test, to determine whether the change from baseline in LIC was significantly different from 0.||||||0|||||||t-test, 2 sided|||Change from baseline after 3 years of deferiprone therapy||||0.0000
72621869|NCT02579759|144774070|SUPERIORITY||Slope|-0.17|STANDARD_ERROR_OF_MEAN|0.07||0.013|TWO_SIDED|95.0|-0.31|-0.04|||Regression, Linear|||"Dose effect:~Dose is defined as a numerical variable proportional to quantity of PXT3003 administered (0 for Placebo, 1 for Dose 1, 2 for Dose 2).~The analysis was performed as follows:~1. Analysis population: modified Full Analysis Set (mFAS)~2. Statistical model: ANCOVA assessing the dose-effect at the mean of 12 and 15 months, adjusting for baseline value and assuming centre as random effect~3. Missing value imputation: multiple imputation taking into account the reason of missingness"||-0.04|-0.31|0.013
72467710|NCT00551135|144458014|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0629|TWO_SIDED||||||ANOVA|||Total score change at 3 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0629
72503980|NCT01025336|144539186|SUPERIORITY_OR_OTHER||geometric mean fold rise|1.0|||||TWO_SIDED|95.0|0.85|1.22|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 1: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||1.22|0.85|
72564803|NCT02443545|144661160|OTHER|One-sample t-test, to determine whether the change from baseline in MRI T2\* was significantly different from 0.||||||0.3146|||||||t-test, 2 sided|||Change from baseline after 1 year of deferiprone therapy||||0.3146
72467711|NCT00551135|144458014|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5721|TWO_SIDED||||||ANOVA|||Total score change at EOT; LS Means from ANOVA model with terms of treatment, pooled center and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.5721
72467712|NCT00551135|144458014|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9713|TWO_SIDED||||||ANOVA|||Total score change at EOT; LS Means from ANOVA model with terms of treatment, pooled center and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.9713
72467713|NCT00551135|144458014|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4809|TWO_SIDED||||||ANOVA|||Total score change at EOT; LS Means from ANOVA model with terms of treatment, pooled center and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.4809
72467714|NCT00551135|144458014|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1561|TWO_SIDED||||||ANOVA|||Rumination change at 3 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.1561
72467715|NCT00551135|144458014|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5267|TWO_SIDED||||||ANOVA|||Rumination change at 3 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.5267
72503981|NCT01025336|144539186|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.9|||||TWO_SIDED|95.0|0.79|1.02|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 1: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||1.02|0.79|
72503982|NCT01025336|144539186|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.8|||||TWO_SIDED|95.0|0.69|0.9|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 1: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||0.90|0.69|
72564804|NCT02443545|144661160|OTHER|One-sample t-test, to determine whether the change from baseline in MRI T2\* was significantly different from 0.||||||0.9454|||||||t-test, 2 sided|||Change from baseline after 2 years of deferiprone therapy||||0.9454
72467716|NCT00551135|144458014|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1125|TWO_SIDED||||||ANOVA|||Rumination change at 3 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.1125
72564805|NCT02443545|144661160|OTHER|One-sample t-test, to determine whether the change from baseline in MRI 2\* was significantly different from 0.||||||0.4336|||||||t-test, 2 sided|||Change from baseline after 3 years of deferiprone therapy||||0.4336
72621870|NCT02579759|144774071|SUPERIORITY||Mean Difference (Final Values)|-0.47|STANDARD_ERROR_OF_MEAN|0.19||0.016|TWO_SIDED|97.5|-0.91|-0.03|||ANCOVA|||"The main analysis was performed as follows:~1. Analysis population: modified Full Analysis Set (mFAS)~2. Statistical model: ANCOVA where the mean at 12 and 15 months of each treatment group was compared against the placebo group, adjusting for the baseline value and assuming centre as a random effect~3. Missing value imputation: multiple imputation taking into account the reason of missingness"||-0.03|-0.91|0.016
72467717|NCT00551135|144458014|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2965|TWO_SIDED||||||ANOVA|||Rumination change at EOT; LS Means from ANOVA model with terms of treatment, pooled center and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.2965
72467718|NCT00551135|144458014|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7774|TWO_SIDED||||||ANOVA|||Rumination change at EOT; LS Means from ANOVA model with terms of treatment, pooled center and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.7774
72503983|NCT01025336|144539186|SUPERIORITY_OR_OTHER||Geometric mean fold rise|1.0|||||TWO_SIDED|95.0|0.82|1.1|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 3: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||1.10|0.82|
72503984|NCT01025336|144539186|SUPERIORITY_OR_OTHER||Geometric mean fold rise|1.1|||||TWO_SIDED|95.0|0.98|1.32|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 3: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||1.32|0.98|
72503985|NCT01025336|144539186|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.7|||||TWO_SIDED|95.0|0.62|0.81|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 3: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||0.81|0.62|
72503986|NCT01025336|144539186|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.5|||||TWO_SIDED|95.0|0.41|0.69|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 4: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||0.69|0.41|
72503987|NCT01025336|144539186|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.7|||||TWO_SIDED|95.0|0.6|0.82|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 4: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||0.82|0.60|
72503988|NCT01025336|144539186|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.6|||||TWO_SIDED|95.0|0.47|0.76|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 4: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||0.76|0.47|
72503989|NCT01025336|144539186|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.8|||||TWO_SIDED|95.0|0.67|0.87|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 5: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||0.87|0.67|
72503990|NCT01025336|144539186|SUPERIORITY_OR_OTHER||Geometric mean fold rise|1.1|||||TWO_SIDED|95.0|0.96|1.3|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 5: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||1.30|0.96|
72503991|NCT01025336|144539186|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.9|||||TWO_SIDED|95.0|0.75|1.02|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 5: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||1.02|0.75|
72503992|NCT01025336|144539186|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.6|||||TWO_SIDED|95.0|0.48|0.79|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 6A: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||0.79|0.48|
72503993|NCT01025336|144539186|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.4|||||TWO_SIDED|95.0|0.32|0.46|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 6A: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||0.46|0.32|
72564806|NCT02443545|144661161|OTHER|One-sample t-test, to determine whether the change from baseline in serum ferritin was significantly different from 0||||||0.9952|||||||t-test, 2 sided|||Change from baseline after 1 year of deferiprone therapy||||0.9952
72564807|NCT02443545|144661161|OTHER|One-sample t-test, to determine whether the change from baseline in serum ferritin was significantly different from 0||||||0.0008|||||||t-test, 2 sided|||Change from baseline after 2 years of deferiprone therapy||||0.0008
72503994|NCT01025336|144539186|SUPERIORITY_OR_OTHER||Geometric mean fold rise|1.3|||||TWO_SIDED|95.0|0.94|1.75|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 6A: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||1.75|0.94|
72503995|NCT01025336|144539186|SUPERIORITY_OR_OTHER||Geometric mean fold rise|1.7|||||TWO_SIDED|95.0|1.32|2.19|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 6B: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||2.19|1.32|
72503996|NCT01025336|144539186|SUPERIORITY_OR_OTHER||Geometric mean fold rise|1.4|||||TWO_SIDED|95.0|1.14|1.6|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 6B: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||1.60|1.14|
72503997|NCT01025336|144539186|SUPERIORITY_OR_OTHER||Geometric mean fold rise|1.6|||||TWO_SIDED|95.0|1.2|2.01|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 6B: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||2.01|1.20|
72503998|NCT01025336|144539186|SUPERIORITY_OR_OTHER||Geometric mean fold rise|1.7|||||TWO_SIDED|95.0|1.24|2.26|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 7F: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||2.26|1.24|
72503999|NCT01025336|144539186|SUPERIORITY_OR_OTHER||Geometric mean fold rise|3.1|||||TWO_SIDED|95.0|2.26|4.3|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 7F: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||4.30|2.26|
72467719|NCT00551135|144458014|SUPERIORITY_OR_OTHER_LEGACY|||||||0.399|TWO_SIDED||||||ANOVA|||Rumination change at EOT; LS Means from ANOVA model with terms of treatment, pooled center and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.3990
72467720|NCT00551135|144458014|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4465|TWO_SIDED||||||ANOVA|||Magnification change at 3 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.4465
72504000|NCT01025336|144539186|SUPERIORITY_OR_OTHER||Geometric mean fold rise|2.0|||||TWO_SIDED|95.0|1.53|2.75|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 7F: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||2.75|1.53|
72621871|NCT02579759|144774071|SUPERIORITY||Mean Difference (Final Values)|-0.28|STANDARD_ERROR_OF_MEAN|0.16||0.084|TWO_SIDED|97.5|-0.65|0.08|||ANCOVA|||"The main analysis was performed as follows:~1. Analysis population: modified Full Analysis Set (mFAS)~2. Statistical model: ANCOVA where the mean at 12 and 15 months of each treatment group was compared against the placebo group, adjusting for the baseline value and assuming centre as a random effect~3. Missing value imputation: multiple imputation taking into account the reason of missingness"||0.08|-0.65|0.084
72467721|NCT00551135|144458014|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4385|TWO_SIDED||||||ANOVA|||Magnification change at 3 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.4385
72467722|NCT00551135|144458014|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2265|TWO_SIDED||||||ANOVA|||Magnification change at 3 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.2265
72467723|NCT00551135|144458014|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5985|TWO_SIDED||||||ANOVA|||Magnification change at EOT; LS Means from ANOVA model with terms of treatment, pooled center and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.5985
72467724|NCT00551135|144458014|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2146|TWO_SIDED||||||ANOVA|||Magnification change at EOT; LS Means from ANOVA model with terms of treatment, pooled center and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.2146
72504001|NCT01025336|144539186|SUPERIORITY_OR_OTHER||Geometric mean fold rise|2.1|||||TWO_SIDED|95.0|1.48|2.95|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 9V: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||2.95|1.48|
72504002|NCT01025336|144539186|SUPERIORITY_OR_OTHER||Geometric mean fold rise|2.7|||||TWO_SIDED|95.0|1.97|3.7|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 9V: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||3.70|1.97|
72504003|NCT01025336|144539186|SUPERIORITY_OR_OTHER||Geometric mean fold rise|2.9|||||TWO_SIDED|95.0|1.99|4.29|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 9V: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||4.29|1.99|
72564808|NCT02443545|144661161|OTHER|One-sample t-test, to determine whether the change from baseline in serum ferritin was significantly different from 0||||||0.042|||||||t-test, 2 sided|||Change from baseline after 3 years of deferiprone therapy||||0.0420
72564809|NCT00536484|144661163|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|0.2||0.0002||95.0|-1.1|-0.4||Significance level p \<0.05|ANCOVA|Terms for treatment, center and baseline as covariate and baseline by treatment interaction.|The LS mean difference \& 95% CI were calculated at mean baseline = 12.9 (centered baseline used in model)|Null hypothesis: the mean change from baseline in micturitions per 24 hours in the fesoterodine group is the same as in the placebo group at Week 12. A sample size of 350 in each arm had at least 85% power to detect a difference of 0.8 between flexible dose fesoterodine \& placebo assuming a standard deviation of 3.52 using a 2-sample t-test with a 0.05 2-sided significance level. Accounting for 10% of randomized subjects not having the primary endpoint data, 390 subjects were needed in each arm||-0.4|-1.1|0.0002
72621872|NCT02579759|144774071|SUPERIORITY||Slope|-0.22|STANDARD_ERROR_OF_MEAN|0.09||0.015|TWO_SIDED|95.0|-0.41|-0.04|||Regression, Linear|||"Dose effect:~Dose is defined as a numerical variable proportional to quantity of PXT3003 administered (0 for Placebo, 1 for Dose 1, 2 for Dose 2).~The analysis was performed as follows:~1. Analysis population: modified Full Analysis Set (mFAS)~2. Statistical model: ANCOVA assessing the dose-effect at the mean of 12 and 15 months, adjusting for baseline value and assuming centre as random effect~3. Missing value imputation: multiple imputation taking into account the reason of missingness"||-0.04|-0.41|0.015
72504004|NCT01025336|144539186|SUPERIORITY_OR_OTHER||Geometric mean fold rise|1.6|||||TWO_SIDED|95.0|1.23|2.05|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 14: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||2.05|1.23|
72504005|NCT01025336|144539186|SUPERIORITY_OR_OTHER||Geometric mean fold rise|1.4|||||TWO_SIDED|95.0|1.18|1.78|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 14: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||1.78|1.18|
72504006|NCT01025336|144539186|SUPERIORITY_OR_OTHER||Geometric mean fold rise|1.2|||||TWO_SIDED|95.0|1.04|1.42|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 14: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||1.42|1.04|
72504007|NCT01025336|144539186|SUPERIORITY_OR_OTHER||Geometric mean fold rise|1.0|||||TWO_SIDED|95.0|0.82|1.19|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 18C: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||1.19|0.82|
72504008|NCT01025336|144539186|SUPERIORITY_OR_OTHER||Geometric mean fold rise|1.1|||||TWO_SIDED|95.0|0.96|1.29|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 18C: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||1.29|0.96|
72504009|NCT01025336|144539186|SUPERIORITY_OR_OTHER||Geometric mean fold rise|1.0|||||TWO_SIDED|95.0|0.89|1.2|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 18C: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||1.20|0.89|
72504010|NCT01025336|144539186|SUPERIORITY_OR_OTHER||Geometric mean fold rise|1.2|||||TWO_SIDED|95.0|1.07|1.46|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 19A: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||1.46|1.07|
72504011|NCT01025336|144539186|SUPERIORITY_OR_OTHER||Geometric mean fold rise|1.4|||||TWO_SIDED|95.0|1.24|1.61|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 19A: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||1.61|1.24|
72504012|NCT01025336|144539186|SUPERIORITY_OR_OTHER||Geometric mean fold rise|1.1|||||TWO_SIDED|95.0|0.96|1.27|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 19A: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||1.27|0.96|
72621873|NCT02579759|144774072|SUPERIORITY||Mean Difference (Final Values)|-0.39|STANDARD_ERROR_OF_MEAN|0.28||0.162|TWO_SIDED|97.5|-1.01|0.23|||ANCOVA|||"The main analysis was performed as follows:~1. Analysis population: modified Full Analysis Set (mFAS)~2. Statistical model: ANCOVA where the mean at 12 and 15 months of each treatment group was compared against the placebo group, adjusting for the baseline value and assuming centre as a random effect~3. Missing value imputation: multiple imputation taking into account the reason of missingness"||0.23|-1.01|0.162
72621874|NCT02579759|144774072|SUPERIORITY||Mean Difference (Final Values)|-0.14|STANDARD_ERROR_OF_MEAN|0.23||0.556|TWO_SIDED|97.5|-0.66|0.39|||ANCOVA|||"The main analysis was performed as follows:~1. Analysis population: modified Full Analysis Set (mFAS)~2. Statistical model: ANCOVA where the mean at 12 and 15 months of each treatment group was compared against the placebo group, adjusting for the baseline value and assuming centre as a random effect~3. Missing value imputation: multiple imputation taking into account the reason of missingness"||0.39|-0.66|0.556
72504013|NCT01025336|144539186|SUPERIORITY_OR_OTHER||Geometric mean fold rises|2.1|||||TWO_SIDED|95.0|1.56|2.8|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations|Serotype 19F: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||2.80|1.56|
72564810|NCT00536484|144661164|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.2||0.0136||95.0|-0.8|-0.1||Significance level p \<0.05|ANCOVA|Terms for center, treatment, baseline covariate and baseline by treatment interaction|Since centered baseline was used in the model, the LS mean difference and its 95% CI were calculated at mean baseline|Week 2 minus Baseline||-0.1|-0.8|0.0136
72467725|NCT00551135|144458014|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3382|TWO_SIDED||||||ANOVA|||Magnification change at EOT; LS Means from ANOVA model with terms of treatment, pooled center and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.3382
72564811|NCT00536484|144661164|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|0.2||0.0002||95.0|-1.1|-0.3||Significance level p \<0.05|ANCOVA|Terms for center, treatment and baseline as covariate and baseline by treatment interaction|Since centered baseline was used in the model, the LS mean difference and its 95% CI were calculated at mean baseline|Week 6 minus Baseline||-0.3|-1.1|0.0002
72564812|NCT00536484|144661165|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.2||0.1057||95.0|-0.9|0.1||Significance level p \<0.05|ANCOVA|Terms for center, treatment and baseline covariate||Week 2 minus Baseline||0.1|-0.9|0.1057
72564813|NCT00536484|144661165|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.3||0.0338||95.0|-1.1|0.0||Significance level p \<0.05|ANCOVA|Terms for center, treatment and baseline covariate||Week 6 minus Baseline||-0.0|-1.1|0.0338
72564814|NCT00536484|144661165|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0|STANDARD_ERROR_OF_MEAN|0.3||0.0003||95.0|-1.5|-0.5||Significance level p \<0.05|ANCOVA|Terms for center, treatment and baseline covariate||Week 12 minus Baseline||-0.5|-1.5|0.0003
72467726|NCT00551135|144458014|SUPERIORITY_OR_OTHER_LEGACY|||||||0.043|TWO_SIDED||||||ANOVA|||Helplessness change at 3 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0430
72467727|NCT00551135|144458014|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1128|TWO_SIDED||||||ANOVA|||Helplessness change at 3 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.1128
72467728|NCT00551135|144458014|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0632|TWO_SIDED||||||ANOVA|||Helplessness change at 3 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0632
72467729|NCT00551135|144458014|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8667|TWO_SIDED||||||ANOVA|||Helplessness change at EOT; LS Means from ANOVA model with terms of treatment, pooled center and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.8667
72467730|NCT00551135|144458014|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6365|TWO_SIDED||||||ANOVA|||Helplessness change at EOT; LS Means from ANOVA model with terms of treatment, pooled center and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.6365
72564815|NCT00536484|144661166|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.2||0.1666||95.0|-0.6|0.1||Significance level p \<0.05|ANCOVA|Terms for center, treatment and baseline covariate||Week 2 minus Baseline||0.1|-0.6|0.1666
72467731|NCT00551135|144458014|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9275|TWO_SIDED||||||ANOVA|||Helplessness change at EOT; LS Means from ANOVA model with terms of treatment, pooled center and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.9275
72467732|NCT00551135|144458016|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2136|TWO_SIDED||||||ANOVA|||PCSS at baseline; LS Means from ANOVA model with terms of treatment, pooled center and baseline score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects have were combined into pooled centers.||||0.2136
72467733|NCT00551135|144458016|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0094|TWO_SIDED||||||ANOVA|||PCSS at baseline; LS Means from ANOVA model with terms of treatment, pooled center and baseline score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects have were combined into pooled centers.||||0.0094
72467734|NCT00551135|144458016|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2131|TWO_SIDED||||||ANOVA|||PCSS at baseline; LS Means from ANOVA model with terms of treatment, pooled center and baseline score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects have were combined into pooled centers.||||0.2131
72467735|NCT00551135|144458016|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3245|TWO_SIDED||||||ANOVA|||PCSS change at EOT; LS Means from ANOVA model with terms of treatment, pooled center and baseline score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects have were combined into pooled centers.||||0.3245
72467736|NCT00551135|144458016|SUPERIORITY_OR_OTHER_LEGACY|||||||0.407|TWO_SIDED||||||ANOVA|||PCSS change at EOT; LS Means from ANOVA model with terms of treatment, pooled center and baseline score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects have were combined into pooled centers.||||0.4070
72467737|NCT00551135|144458016|SUPERIORITY_OR_OTHER_LEGACY|||||||0.349|TWO_SIDED||||||ANOVA|||PCSS change at EOT; LS Means from ANOVA model with terms of treatment, pooled center and baseline score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects have were combined into pooled centers.||||0.3490
72467738|NCT00551135|144458016|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1122|TWO_SIDED||||||ANOVA|||MCSS at baseline; LS Means from ANOVA model with terms of treatment, pooled center and baseline score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects have were combined into pooled centers.||||0.1122
72467739|NCT00551135|144458016|SUPERIORITY_OR_OTHER_LEGACY|||||||0.138|TWO_SIDED||||||ANOVA|||MCSS at baseline; LS Means from ANOVA model with terms of treatment, pooled center and baseline score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects have were combined into pooled centers.||||0.1380
72564816|NCT00536484|144661166|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.2||0.0506||95.0|-0.8|0.0||Significance level p \<0.05|ANCOVA|Terms for center, treatment and baseline covariate||Week 6 minus Baseline||0.0|-0.8|0.0506
72394612|NCT02310568|144295794|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.3||0.965|TWO_SIDED|90.0|-0.5|0.5|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - Placebo). Week 4: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||0.5|-0.5|0.965
72394613|NCT02310568|144295794|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|0.3||0.389|TWO_SIDED|90.0|-0.2|0.7|||Mixed-Effects Model Repeated Measure|||(PF-06372865 2.5 mg - Placebo). Week 4: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||0.7|-0.2|0.389
72394614|NCT02310568|144295794|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.34||0.433|TWO_SIDED|90.0|-0.8|0.3|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 4: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||0.3|-0.8|0.433
72467740|NCT00551135|144458016|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2023|TWO_SIDED||||||ANOVA|||MCSS at baseline; LS Means from ANOVA model with terms of treatment, pooled center and baseline score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects have were combined into pooled centers.||||0.2023
72467741|NCT00551135|144458016|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2639|TWO_SIDED||||||ANOVA|||MCSS change at EOT; LS Means from ANOVA model with terms of treatment, pooled center and baseline score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects have were combined into pooled centers.||||0.2639
72467742|NCT00551135|144458016|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2524|TWO_SIDED||||||ANOVA|||MCSS change at EOT; LS Means from ANOVA model with terms of treatment, pooled center and baseline score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects have were combined into pooled centers.||||0.2524
72467743|NCT00551135|144458016|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0832|TWO_SIDED||||||ANOVA|||MCSS change at EOT; LS Means from ANOVA model with terms of treatment, pooled center and baseline score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects have were combined into pooled centers.||||0.0832
72564817|NCT00536484|144661166|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.2||0.0014||95.0|-1.0|-0.2||Significance level p \<0.05|ANCOVA|Terms for center, treatment and baseline covariate||Week 12 minus Baseline||-0.2|-1.0|0.0014
72394615|NCT02310568|144295794|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.5||0.94|TWO_SIDED|90.0|-0.9|0.8|||LS Mean Difference|||(PF-06372865 7.5 mg - Placebo). Week 5: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||0.8|-0.9|0.940
72467744|NCT00551135|144458017|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2371|TWO_SIDED|||||P-values are derived from Cochran-Mantel-Haenszel test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||1 month PS.||||0.2371
72467745|NCT00551135|144458017|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4435|TWO_SIDED|||||P-values are derived from Cochran-Mantel-Haenszel test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||1 month PS.||||0.4435
72467746|NCT00551135|144458017|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1692|TWO_SIDED|||||P-values are derived from Cochran-Mantel-Haenszel test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||1 month PS.||||0.1692
72467747|NCT00551135|144458017|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8169|TWO_SIDED|||||P-values are derived from Cochran-Mantel-Haenszel test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||3 month PS.||||0.8169
72467748|NCT00551135|144458017|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5592|TWO_SIDED|||||P-values are derived from Cochran-Mantel-Haenszel test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||3 month PS.||||0.5592
72467749|NCT00551135|144458017|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4453|TWO_SIDED|||||P-values are derived from Cochran-Mantel-Haenszel test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||3 month PS.||||0.4453
72467750|NCT00551135|144458017|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4795|TWO_SIDED|||||P-values are derived from Cochran-Mantel-Haenszel test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||6 month PS.||||0.4795
72467751|NCT00551135|144458017|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2733|TWO_SIDED|||||P-values are derived from Cochran-Mantel-Haenszel test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||6 month PS.||||0.2733
72467752|NCT00551135|144458017|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3173|TWO_SIDED|||||P-values are derived from Cochran-Mantel-Haenszel test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||6 month PS.||||0.3173
72564818|NCT00536484|144661167|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.1||0.2054||95.0|-0.4|0.1||Significance level p \<0.05|ANCOVA|Terms for center, treatment and baseline as covariate and baseline by treatment interaction|Since centered baseline was used in the model, the LS mean difference and its 95% CI were calculated at mean baseline|Week 2 minus Baseline||0.1|-0.4|0.2054
72564819|NCT00536484|144661167|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.1||0.0225||95.0|-0.6|0.0||Significance level p \<0.05|ANCOVA|Terms for center, treatment and baseline as covariate and baseline by treatment interaction|Since centered baseline was used in the model, the LS mean difference and its 95% CI were calculated at mean baseline|Week 6 minus Baseline||-0.0|-0.6|0.0225
72467753|NCT00858247|144458020|SUPERIORITY_OR_OTHER|||||||0.95|||||||ANCOVA|||||||0.95
72504014|NCT01025336|144539186|SUPERIORITY_OR_OTHER||Geometric mean fold rise|2.3|||||TWO_SIDED|95.0|1.82|2.88|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 19F: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||2.88|1.82|
72504015|NCT01025336|144539186|SUPERIORITY_OR_OTHER||Geometric mean fold rise|1.5|||||TWO_SIDED|95.0|1.18|1.9|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 19F: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||1.90|1.18|
72504016|NCT01025336|144539186|SUPERIORITY_OR_OTHER||Geometric mean fold rise|1.1|||||TWO_SIDED|95.0|0.89|1.48|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 23F: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||1.48|0.89|
72504017|NCT01025336|144539186|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.7|||||TWO_SIDED|95.0|0.63|0.85|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 23F: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||0.85|0.63|
72504018|NCT01025336|144539186|SUPERIORITY_OR_OTHER||Geometric mean fold rise|1.2|||||TWO_SIDED|95.0|0.99|1.51|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 23F: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||1.51|0.99|
72564820|NCT00536484|144661167|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.1||0.0167||95.0|-0.6|-0.1||Significance level p \<0.05|ANCOVA|Terms for center, treatment and baseline as covariate and baseline by treatment interaction|Since centered baseline was used in the model, the LS mean difference and its 95% CI were calculated at mean baseline|Week 12 minus Baseline||-0.1|-0.6|0.0167
72467754|NCT00858247|144458021|SUPERIORITY_OR_OTHER|||||||0.8|||||||ANCOVA|||||||0.80
72467755|NCT00858247|144458022|SUPERIORITY_OR_OTHER|||||||0.65|||||||ANCOVA|||||||0.65
72467756|NCT00858247|144458023|SUPERIORITY_OR_OTHER|||||||0.68|||||||ANCOVA|||||||0.68
72504019|NCT01025336|144539187|SUPERIORITY_OR_OTHER||Geometric mean fold rise|1.2|||||TWO_SIDED|95.0|1.03|1.31|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 1: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||1.31|1.03|
72467757|NCT00858247|144458024|SUPERIORITY_OR_OTHER|||||||0.4|||||||ANCOVA|||||||0.40
72467758|NCT00858247|144458025|SUPERIORITY_OR_OTHER|||||||0.47|||||||ANCOVA|||||||0.47
72467759|NCT03311269|144458050|OTHER|The null hypothesis is that the mean change from baseline for the primary efficacy endpoint=0. The alternative hypothesis is that the mean change does not =0. The primary analysis will be a one-sample t-test for both treatment groups combined, to test the null hypothesis that the mean change from baseline equals 0. Primary analysis will be performed for each treatment group separately.|Mean Difference (Final Values)|-4.2|||<|0.001|TWO_SIDED|95.0|-6.2|-2.3||This p-value corresponds to the change from Baseline to Week 12 for both treatment groups (ClariVein RES 1% Injection and ClariVein RES 3% Injection) combined.|t-test, 2 sided|One-Sample||Continuous variables summarized using descriptive statistics, specifically the mean, median, standard deviation, minimum and maximum. Categorical variables summarized using frequencies and percentages. All statistical tests will be performed at the 0.05 significance level (p -value ≤ 0.050) unless otherwise indicated. For efficacy analyses, missing post-treatment data will be imputed using last observation carried forward (LOCF). Missing safety data will not be imputed.||-2.3|-6.2|<0.001
72504020|NCT01025336|144539187|SUPERIORITY_OR_OTHER||Geometric mean fold rise|1.0|||||TWO_SIDED|95.0|0.91|1.16|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 1: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||1.16|0.91|
72504021|NCT01025336|144539187|SUPERIORITY_OR_OTHER||Geometric mean fold rise|1.2|||||TWO_SIDED|95.0|1.07|1.37|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 3: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||1.37|1.07|
72564821|NCT00536484|144661168|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.1||0.8019||95.0|-0.2|0.1||Significance level p \<0.05|ANOVA|||Week 2 minus Baseline||0.1|-0.2|0.8019
72467760|NCT03311269|144458050|OTHER|The null hypothesis is that the mean change from baseline for the primary efficacy endpoint=0. The alternative hypothesis is that the mean change does not =0. The primary analysis will be a one-sample t-test for both treatment groups combined, to test the null hypothesis that the mean change from baseline equals 0. Primary analysis will be performed for each treatment group separately.|Mean Difference (Final Values)|-3.4||||0.011|TWO_SIDED|95.0|-5.8|-1.0||This p-value corresponds to the change from Baseline to Week 12 for the ClariVein RES 1% Injection treatment group.|t-test, 2 sided|One-Sample||All statistical tests will be performed at the 0.05 significance level (p -value ≤ 0.050) unless otherwise indicated.||-1.0|-5.8|0.011
72394616|NCT02310568|144295794|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.49||0.757|TWO_SIDED|90.0|-1.0|0.7|||Mixed-Effects Model Repeated Measure|||(PF-06372865 2.5 mg - Placebo). Week 5: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||0.7|-1.0|0.757
72467761|NCT03311269|144458050|OTHER|The null hypothesis is that the mean change from baseline for the primary efficacy endpoint=0. The alternative hypothesis is that the mean change does not =0. The primary analysis will be a one-sample t-test for both treatment groups combined, to test the null hypothesis that the mean change from baseline equals 0. Primary analysis will be performed for each treatment group separately.|Mean Difference (Final Values)|-5.1||||0.01|TWO_SIDED|95.0|-8.7|-1.6||This p-value corresponds to the change from Baseline to Week 12 for the ClariVein RES 3% Injection treatment group.|t-test, 2 sided|One-Sample||All statistical tests will be performed at the 0.05 significance level (p -value ≤ 0.050) unless otherwise indicated.||-1.6|-8.7|0.010
72467762|NCT03311269|144458050|OTHER|An ANCOVA was performed to compare the change from baseline for ClariVein RES 1% Injection versus ClariVein RES 3% Injection with treatment as the class variable and with baseline score as the covariate|Least-Squares Mean Difference|-1.2||||0.531|TWO_SIDED|95.0|-3.7|1.3||This p-value corresponds to the difference between treatment groups (ClariVein RES 1% Injection versus ClariVein RES 3% Injection).|ANCOVA|||All statistical tests will be performed at the 0.05 significance level (p -value ≤ 0.050) unless otherwise indicated.||1.3|-3.7|0.531
72467763|NCT03311269|144458051|OTHER||Descriptive (Percentage)|94.4|||||TWO_SIDED|95.0|72.7|99.9|||||The count of the combined treatment group for the elimination of saphenous vein reflux at Week 12 posttreatment is 17/18 (94.4%).|The secondary efficacy endpoint, the elimination of saphenous vein reflux at Week 12 posttreatment, will be summarized for both treatments combined using the count and percentage, together with a 95% Wilson (score) confidence interval for the proportion.||99.9|72.7|
72467764|NCT03311269|144458051|OTHER||Percentage Difference|11.1||||1|TWO_SIDED|95.0|-20.5|42.8||All statistical tests will be performed at the 0.05 significance level (p -value ≤ 0.050) unless otherwise indicated.|Chi-squared|||For elimination of saphenous vein reflux at Week 12 posttreatment, the treatment difference for ClariVein RES 1% Injection versus ClariVein RES 3% Injection for the proportion was assessed by a chi-square test together with a 95% Wilson (score) confidence interval for the treatment difference.||42.8|-20.5|1.000
72467765|NCT01721746|144458072|SUPERIORITY||Hazard Ratio (HR)|0.86|||||TWO_SIDED|95.0|0.68|1.08|||||From stratified cox proportional hazard model with treatment group as a single covariate, stratified by BRAF status, prior anti-CTLA-4 benefit, and PD-L1 status (IVRS source)|Hazard Ratio is Nivolumab 3 mg/kg (IV) over Investigator's Choice (Dacarbazine or Carboplatin+Paclitaxel)||1.08|0.68|
72467766|NCT01721746|144458073|SUPERIORITY||Hazard Ratio (HR)|1.03|||||TWO_SIDED|95.1|0.78|1.36|||||Stratified Cox proportional hazard model.|Hazard Ratio is Nivolumab 3 mg/kg (IV) over Investigator's Choice (Dacarbazine or Carboplatin+Paclitaxel)||1.36|0.78|
72504022|NCT01025336|144539187|SUPERIORITY_OR_OTHER||Geometric mean fold rise|1.0|||||TWO_SIDED|95.0|0.91|1.13|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 3: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||1.13|0.91|
72467767|NCT01721746|144458074|SUPERIORITY||Odds Ratio (OR)|1.13|||||TWO_SIDED|95.0|0.44|3.16||||||For \<5% PD-L1 expression. Ratio of Nivolumab over Investigator's Choice||3.16|0.44|
72467768|NCT01721746|144458074|SUPERIORITY||Odds Ratio (OR)|5.49|||||TWO_SIDED|95.0|1.92|19.08||||||For \>=5% PD-L1 expression. Ratio of Nivolumab over Investigator's Choice||19.08|1.92|
72467769|NCT01721746|144458075|SUPERIORITY||Hazard Ratio (HR)|0.71|||||TWO_SIDED|95.0|0.5|1.01|||||From unstratified Cox proportional hazard model|PD-L1 Positive||1.01|0.50|
72467770|NCT01721746|144458076|SUPERIORITY||Hazard Ratio (HR)|1.03|||||TWO_SIDED|95.0|0.75|1.41|||||From unstratified Cox proportional hazard model|PD-L1 Negative||1.41|0.75|
72504023|NCT01025336|144539187|SUPERIORITY_OR_OTHER||Geometric mean fold rise|2.1|||||TWO_SIDED|95.0|1.6|2.68|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 4: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||2.68|1.60|
72504024|NCT01025336|144539187|SUPERIORITY_OR_OTHER||Geometric mean fold rise|2.4|||||TWO_SIDED|95.0|1.82|3.24|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 4: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||3.24|1.82|
72467771|NCT04358068|144458084|SUPERIORITY|Participant specific durations were compared between randomized arms using a two-sided Wilcoxon test with a two-sided 5% type I error rate||||||0.51||||||Wilcoxon Test was not stratified by high/low risk because of the small number enrolled|Wilcoxon (Mann-Whitney)|||||||0.51
72467772|NCT04358068|144458085|SUPERIORITY|Participant specific durations were compared between randomized arms using a two-sided Wilcoxon test with a two-sided 5% type I error rate||||||0.79||||||Wilcoxon Test was not stratified by high/low risk because of the small number enrolled|Wilcoxon (Mann-Whitney)|||||||0.79
72467773|NCT04358068|144458086|SUPERIORITY|Participant specific AUCs were compared between randomized arms using a two-sided Wilcoxon test with a two-sided 5% type I error rate||||||0.53||||||Wilcoxon Test was not stratified by high/low risk because of the small number enrolled|Wilcoxon (Mann-Whitney)|||||||0.53
72467774|NCT04358068|144458087|SUPERIORITY|Participant specific durations were compared between randomized arms using a two-sided Wilcoxon test with a two-sided 5% type I error rate||||||0.83||||||Wilcoxon Test was not stratified by high/low risk because of the small number enrolled|Wilcoxon (Mann-Whitney)|||||||0.83
72467775|NCT00239681|144458091|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.56|||<|0.0001||95.0|0.46|0.69|||Regression, Cox||The hazard ratio shows (Rosuvastatin hazard/Placebo hazard)|||0.69|0.46|<0.0001
72467776|NCT00239681|144458092|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.8|||<|0.021||95.0|0.67|0.97|||Regression, Cox||The hazard ratio shows (Rosuvastatin hazard/Placebo hazard)|||0.97|0.67|<0.021
72467777|NCT00239681|144458093|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.84|||<|0.172||95.0|0.65|1.08|||Regression, Cox||The hazard ratio shows (Rosuvastatin hazard/Placebo hazard)|||1.08|0.65|<0.172
72504025|NCT01025336|144539187|SUPERIORITY_OR_OTHER||Geometric mean fold rise|1.8|||||TWO_SIDED|95.0|1.55|2.03|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 5: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||2.03|1.55|
72504026|NCT01025336|144539187|SUPERIORITY_OR_OTHER||Geometric mean fold rise|1.8|||||TWO_SIDED|95.0|1.54|2.09|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 5: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||2.09|1.54|
72564822|NCT00536484|144661168|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.1||0.3881||95.0|-0.2|0.1||Significance level p \<0.05|ANOVA|||Week 6 minus Baseline||0.1|-0.2|0.3881
72564823|NCT00536484|144661168|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.1||0.324||95.0|-0.2|0.1||Significance level p \<0.05|ANOVA|||Week 12 minus Baseline||0.1|-0.2|0.3240
72564824|NCT00536484|144661169|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.1||0.8279||95.0|-0.2|0.1||Significance level p \<0.05|ANOVA|||Week 2 minus Baseline||0.1|-0.2|0.8279
72564825|NCT00536484|144661169|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.1||0.5059||95.0|-0.2|0.1||Significance level p \<0.05|ANOVA|||Week 6 minus Baseline||0.1|-0.2|0.5059
72564826|NCT00536484|144661169|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.1||0.0806||95.0|-0.4|0.0||Significance level p \<0.05|ANOVA|||Week 12 minus Baseline||0.0|-0.4|0.0806
72564827|NCT00536484|144661170|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.7|STANDARD_ERROR_OF_MEAN|0.7||0.0203||95.0|-3.2|-0.3||Significance level p \<0.05|ANCOVA|Terms for center, treatment and baseline covariate||Week 2 minus Baseline||-0.3|-3.2|0.0203
72564828|NCT00536484|144661170|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.7|STANDARD_ERROR_OF_MEAN|0.8||0.0007||95.0|-4.2|-1.1||Significance level p \<0.05|ANCOVA|Terms for center, treatment and baseline covariate||Week 6 minus Baseline||-1.1|-4.2|0.0007
72564829|NCT00536484|144661170|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.3|STANDARD_ERROR_OF_MEAN|0.8|<|0.0001||95.0|-4.9|-1.7||Significance level p \<0.05|ANCOVA|Terms for center, treatment and baseline covariate||Week 12 minus Baseline||-1.7|-4.9|<0.0001
72621875|NCT02579759|144774072|SUPERIORITY||Slope|-0.17|STANDARD_ERROR_OF_MEAN|0.13||0.204|TWO_SIDED|95.0|-0.43|0.09|||Regression, Linear|||"Dose is defined as a numerical variable proportional to quantity of PXT3003 administered (0 for Placebo, 1 for Dose 1, 2 for Dose 2).~The analysis was performed as follows:~1. Analysis population: modified Full Analysis Set (mFAS)~2. Statistical model: ANCOVA assessing the dose-effect at the mean of 12 and 15 months, adjusting for baseline value and assuming centre as random effect~3. Missing value imputation: multiple imputation taking into account the reason of missingness"||0.09|-0.43|0.204
72564830|NCT00536484|144661171|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.8|STANDARD_ERROR_OF_MEAN|1.5|<|0.0001||95.0|-10.7|-4.9||Significance level p \<0.05|ANCOVA|Terms for center, treatment and baseline as covariate and baseline by treatment interaction|Since centered baseline was used in the model, the LS mean difference and its 95% CI were calculated at mean baseline|Week 12 minus Baseline||-4.9|-10.7|<0.0001
72564831|NCT00536484|144661172|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.4|STANDARD_ERROR_OF_MEAN|1.6|<|0.0001||95.0|5.3|11.5||Significance level p \<0.05|ANCOVA|Terms for center, treatment and baseline as covariate and baseline by treatment interaction|Since centered baseline was used in the model, the LS mean difference and its 95% CI were calculated at mean baseline|"Week 12 minus Baseline~Concern domain"||11.5|5.3|<0.0001
72504027|NCT01025336|144539187|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.9|||||TWO_SIDED|95.0|0.79|1.07|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 6A: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||1.07|0.79|
72504028|NCT01025336|144539187|SUPERIORITY_OR_OTHER||Geometric mean fold rise|1.9|||||TWO_SIDED|95.0|1.48|2.55|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 6A: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||2.55|1.48|
72564832|NCT00536484|144661172|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.1|STANDARD_ERROR_OF_MEAN|1.6|<|0.0001||95.0|3.9|10.2||Significance level p \<0.05|ANCOVA|Terms for center, treatment and baseline as covariate and baseline by treatment interaction|Since centered baseline was used in the model, the LS mean difference and its 95% CI were calculated at mean baseline|"Week 12 minus Baseline~Coping domain"||10.2|3.9|<0.0001
72564833|NCT00536484|144661172|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.7|STANDARD_ERROR_OF_MEAN|1.6||0.0036||95.0|1.5|7.8||Significance level p \<0.05|ANCOVA|Terms for center, treatment and baseline as covariate||"Week 12 minus Baseline~Sleep domain"||7.8|1.5|0.0036
72564834|NCT00536484|144661172|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.7|STANDARD_ERROR_OF_MEAN|1.1||0.0007||95.0|1.6|5.8||Significance level p \<0.05|ANCOVA|Terms for center, treatment and baseline as covariate and baseline by treatment interaction|Since centered baseline was used in the model, the LS mean difference and its 95% CI were calculated at mean baseline|"Week 12 minus Baseline~Social interaction domain"||5.8|1.6|0.0007
72564835|NCT00536484|144661172|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.2|STANDARD_ERROR_OF_MEAN|1.3|<|0.0001||95.0|3.6|8.9||Significance level p \<0.05|ANCOVA|Terms for center, treatment and baseline as covariate and baseline by treatment interaction|Since centered baseline was used in the model, the LS mean difference and its 95% CI were calculated at mean baseline|"Week 12 minus Baseline~HRQL scale score total"||8.9|3.6|<0.0001
72564836|NCT00536484|144661173|SUPERIORITY_OR_OTHER|||||||0.0087||95.0||||Significance level p \<0.05|Cochran-Mantel-Haenszel|The CMH test used modified ridit scores which were based on the ranks of the observations rather than the observed values.||Treatment difference at Week 2||||0.0087
72394617|NCT02310568|144295794|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.46||0.836|TWO_SIDED|90.0|-0.7|0.9|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 5: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||0.9|-0.7|0.836
72394618|NCT02310568|144295794|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.56||0.827|TWO_SIDED|90.0|-0.9|1.1|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - Placebo). Week 6: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||1.1|-0.9|0.827
72394619|NCT02310568|144295794|SUPERIORITY_OR_OTHER||LS Mean Difference|0.4|STANDARD_ERROR_OF_MEAN|0.55||0.507|TWO_SIDED|90.0|-0.6|1.3|||Mixed-Effects Model Repeated Measure|||(PF-06372865 2.5 mg - Placebo). Week 6: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||1.3|-0.6|0.507
72394620|NCT02310568|144295794|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.51||0.632|TWO_SIDED|90.0|-1.1|0.6|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 6: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||0.6|-1.1|0.632
72394621|NCT02310568|144295794|SUPERIORITY_OR_OTHER||LS Mean Difference|0.4|STANDARD_ERROR_OF_MEAN|0.51||0.442|TWO_SIDED|90.0|-0.5|1.3|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - Placebo). Week 7: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||1.3|-0.5|0.442
72394622|NCT02310568|144295794|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.5||0.643|TWO_SIDED|90.0|-1.1|0.6|||Mixed-Effects Model Repeated Measure|||(PF-06372865 2.5 mg - Placebo). Week 7: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||0.6|-1.1|0.643
72394623|NCT02310568|144295794|SUPERIORITY_OR_OTHER||LS Mean Difference|0.6|STANDARD_ERROR_OF_MEAN|0.47||0.188|TWO_SIDED|90.0|-0.2|1.5|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 7: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||1.5|-0.2|0.188
72394624|NCT02310568|144295794|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.65||0.701|TWO_SIDED|90.0|-1.4|0.9|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - Placebo). Week 8: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||0.9|-1.4|0.701
72394625|NCT02310568|144295794|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.63||0.271|TWO_SIDED|90.0|-1.8|0.4|||Mixed-Effects Model Repeated Measure|||(PF-06372865 2.5 mg - Placebo). Week 8: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||0.4|-1.8|0.271
72394626|NCT02310568|144295794|SUPERIORITY_OR_OTHER||LS Mean Difference|0.5|STANDARD_ERROR_OF_MEAN|0.6||0.445|TWO_SIDED|90.0|-0.6|1.5|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 8: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||1.5|-0.6|0.445
72394627|NCT02310568|144295794|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.36||0.714|TWO_SIDED|90.0|-0.8|0.5|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - Placebo). Combined Stage 1 (Week 4) and Stage 2 (Week 8): Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect.||0.5|-0.8|0.714
72394628|NCT02310568|144295794|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.35||0.515|TWO_SIDED|90.0|-0.8|0.4|||Mixed-Effects Model Repeated Measure|||(PF-06372865 2.5 mg - Placebo). Combined Stage 1 (Week 4) and Stage 2 (Week 8): Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect.||0.4|-0.8|0.515
72394629|NCT02310568|144295794|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.34||0.778|TWO_SIDED|90.0|-0.5|0.7|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Combined Stage 1 (Week 4) and Stage 2 (Week 8): Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect.||0.7|-0.5|0.778
72394630|NCT02310568|144295797|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.93||0.562|TWO_SIDED|90.0|-2.1|1.0|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - Placebo). Week 1: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||1.0|-2.1|0.562
72467778|NCT00239681|144458094|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.27|||<|0.015||95.0|1.05|1.53|||Regression, Cox||The hazard ratio shows (Rosuvastatin hazard/Placebo hazard)|||1.53|1.05|<0.015
72467779|NCT00239681|144458095|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.57||||0.018||95.0|0.35|0.91|||Regression, Cox||The hazard ratio shows (Rosuvastatin hazard/Placebo hazard)|||0.91|0.35|0.018
72467780|NCT00239681|144458096|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.06||||0.548||95.0|0.88|1.28|||Regression, Cox||The hazard ratio shows (Rosuvastatin hazard/Placebo hazard)|||1.28|0.88|0.548
72467781|NCT03599622|144458106|SUPERIORITY|Cochran-Mantel-Haenszel stratified by geographic region (US, Japan, Rest of World), prior exposure to tumor necrosis factor inhibitor (TNFi; Exposed/Naive), and concomitant corticosteroid use (Yes/No).|Risk Difference (RD)|4.3||||0.5812|TWO_SIDED|95.0|-11.0|19.5||Based on a 2-sided test at a significance level of 0.025.|Mantel Haenszel||3 mg BMS-986165 (numerator) vs Placebo (denominator)|||19.5|-11.0|0.5812
72467782|NCT03599622|144458106|SUPERIORITY|Cochran-Mantel-Haenszel stratified by geographic region (US, Japan, Rest of World), prior exposure to tumor necrosis factor inhibitor (TNFi; Exposed/Naive), and concomitant corticosteroid use (Yes/No).|Odds Ratio (OR)|1.2||||0.5812|TWO_SIDED|95.0|0.6|2.5||Based on a 2-sided test at a significance level of 0.025.|Mantel Haenszel||3 mg BMS-986165 (numerator) vs Placebo (denominator)|||2.5|0.6|0.5812
72467783|NCT03599622|144458106|SUPERIORITY|Cochran-Mantel-Haenszel stratified by geographic region (US, Japan, Rest of World), prior exposure to tumor necrosis factor inhibitor (TNFi; Exposed/Naive), and concomitant corticosteroid use (Yes/No).|Risk Difference (RD)|-6.3||||0.372|TWO_SIDED|95.0|-20.2|7.6||Based on a 2-sided test at a significance level of 0.025.|Mantel Haenszel||6 mg BMS-986165 (numerator) vs Placebo (denominator)|||7.6|-20.2|0.3720
72467784|NCT03599622|144458106|SUPERIORITY|Cochran-Mantel-Haenszel stratified by geographic region (US, Japan, Rest of World), prior exposure to tumor necrosis factor inhibitor (TNFi; Exposed/Naive), and concomitant corticosteroid use (Yes/No).|Odds Ratio (OR)|0.7||||0.372|TWO_SIDED|95.0|0.3|1.5||Based on a 2-sided test at a significance level of 0.025.|Mantel Haenszel||6 mg BMS-986165 (numerator) vs Placebo (denominator)|||1.5|0.3|0.3720
72467785|NCT03599622|144458107|SUPERIORITY|Cochran-Mantel-Haenszel stratified by geographic region (US, Japan, Rest of World), prior exposure to tumor necrosis factor inhibitor (TNFi; Exposed/Naive), and concomitant corticosteroid use (Yes/No).|Risk Difference (RD)|15.0||||0.0198|TWO_SIDED|95.0|3.7|26.3||Based on a 2-sided test at a significance level of 0.025.|Mantel Haenszel||3 mg BMS-986165 (numerator) vs Placebo (denominator)|||26.3|3.7|0.0198
72467786|NCT03599622|144458107|SUPERIORITY|Cochran-Mantel-Haenszel stratified by geographic region (US, Japan, Rest of World), prior exposure to tumor necrosis factor inhibitor (TNFi; Exposed/Naive), and concomitant corticosteroid use (Yes/No).|Odds Ratio (OR)|3.4||||0.0198|TWO_SIDED|95.0|1.2|9.8||Based on a 2-sided test at a significance level of 0.025.|Mantel Haenszel||3 mg BMS-986165 (numerator) vs Placebo (denominator)|||9.8|1.2|0.0198
72467787|NCT03599622|144458107|SUPERIORITY|Cochran-Mantel-Haenszel stratified by geographic region (US, Japan, Rest of World), prior exposure to tumor necrosis factor inhibitor (TNFi; Exposed/Naive), and concomitant corticosteroid use (Yes/No).|Risk Difference (RD)|8.2||||0.1584|TWO_SIDED|95.0|-2.6|19.0||Based on a 2-sided test at a significance level of 0.025.|Mantel Haenszel||6 mg BMS-986165 (numerator) vs Placebo (denominator)|||19.0|-2.6|0.1584
72504029|NCT01025336|144539187|SUPERIORITY_OR_OTHER||Geometric mean fold rise|1.3|||||TWO_SIDED|95.0|1.05|1.53|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 6B: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||1.53|1.05|
72564837|NCT00536484|144661173|SUPERIORITY_OR_OTHER|||||||0.0008||95.0||||Significance level p \<0.05|Cochran-Mantel-Haenszel|The CMH test used modified ridit scores which were based on the ranks of the observations rather than the observed values.||Treatment difference at Week 6||||0.0008
72467788|NCT03599622|144458107|SUPERIORITY|Cochran-Mantel-Haenszel stratified by geographic region (US, Japan, Rest of World), prior exposure to tumor necrosis factor inhibitor (TNFi; Exposed/Naive), and concomitant corticosteroid use (Yes/No).|Odds Ratio (OR)|2.1||||0.1584|TWO_SIDED|95.0|0.7|6.1||Based on a 2-sided test at a significance level of 0.025.|Mantel Haenszel||6 mg BMS-986165 (numerator) vs Placebo (denominator)|||6.1|0.7|0.1584
72467789|NCT03599622|144458108|SUPERIORITY|Cochran-Mantel-Haenszel stratified by geographic region (US, Japan, Rest of World), prior exposure to tumor necrosis factor inhibitor (TNFi; Exposed/Naive), and concomitant corticosteroid use (Yes/No).|Risk Difference (RD)|7.7||||0.3464|TWO_SIDED|95.0|-8.2|23.6||Based on a 2-sided test at a significance level of 0.025.|Mantel Haenszel||3 mg BMS-986165 (numerator) vs Placebo (denominator)|||23.6|-8.2|0.3464
72467790|NCT03599622|144458108|SUPERIORITY|Cochran-Mantel-Haenszel stratified by geographic region (US, Japan, Rest of World), prior exposure to tumor necrosis factor inhibitor (TNFi; Exposed/Naive), and concomitant corticosteroid use (Yes/No).|Odds Ratio (OR)|1.4||||0.3464|TWO_SIDED|95.0|0.7|2.8||Based on a 2-sided test at a significance level of 0.025.|Mantel Haenszel||3 mg BMS-986165 (numerator) vs Placebo (denominator)|||2.8|0.7|0.3464
72467791|NCT03599622|144458108|SUPERIORITY|Cochran-Mantel-Haenszel stratified by geographic region (US, Japan, Rest of World), prior exposure to tumor necrosis factor inhibitor (TNFi; Exposed/Naive), and concomitant corticosteroid use (Yes/No).|Risk Difference (RD)|-1.2||||0.8857|TWO_SIDED|95.0|-17.0|14.7||Based on a 2-sided test at a significance level of 0.025.|Mantel Haenszel||6 mg BMS-986165 (numerator) vs Placebo (denominator)|||14.7|-17.0|0.8857
72504030|NCT01025336|144539187|SUPERIORITY_OR_OTHER||Geometric mean fold rise|1.9|||||TWO_SIDED|95.0|1.5|2.51|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 6B: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||2.51|1.50|
72504031|NCT01025336|144539187|SUPERIORITY_OR_OTHER||Geometric mean fold rise|2.6|||||TWO_SIDED|95.0|1.98|3.5|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 7F: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||3.50|1.98|
72467792|NCT03599622|144458108|SUPERIORITY|Cochran-Mantel-Haenszel stratified by geographic region (US, Japan, Rest of World), prior exposure to tumor necrosis factor inhibitor (TNFi; Exposed/Naive), and concomitant corticosteroid use (Yes/No).|Odds Ratio (OR)|1.0||||0.8857|TWO_SIDED|95.0|0.5|1.9||Based on a 2-sided test at a significance level of 0.025.|Mantel Haenszel||6 mg BMS-986165 (numerator) vs Placebo (denominator)|||1.9|0.5|0.8857
72467793|NCT03599622|144458109|SUPERIORITY|Cochran-Mantel-Haenszel stratified by geographic region (US, Japan, Rest of World), prior exposure to tumor necrosis factor inhibitor (TNFi; Exposed/Naive), and concomitant corticosteroid use (Yes/No).|Risk Difference (RD)|8.1||||0.2841|TWO_SIDED|95.0|-6.7|22.9||Based on a 2-sided test at a significance level of 0.025.|Mantel Haenszel||3 mg BMS-986165 (numerator) vs Placebo (denominator)|||22.9|-6.7|0.2841
72467794|NCT03599622|144458109|SUPERIORITY|Cochran-Mantel-Haenszel stratified by geographic region (US, Japan, Rest of World), prior exposure to tumor necrosis factor inhibitor (TNFi; Exposed/Naive), and concomitant corticosteroid use (Yes/No).|Odds Ratio (OR)|1.5||||0.2841|TWO_SIDED|95.0|0.7|3.1||Based on a 2-sided test at a significance level of 0.025.|Mantel Haenszel||3 mg BMS-986165 (numerator) vs Placebo (denominator)|||3.1|0.7|0.2841
72621876|NCT02579759|144774073|SUPERIORITY||Mean Difference (Final Values)|-0.43|STANDARD_ERROR_OF_MEAN|0.36||0.232|TWO_SIDED|97.5|-1.25|0.38|||ANCOVA|||"The main analysis was performed as follows:~1. Analysis population: modified Full Analysis Set (mFAS)~2. Statistical model: ANCOVA where the mean at 12 and 15 months of each treatment group was compared against the placebo group, adjusting for the baseline value and assuming centre as a random effect~3. Missing value imputation: multiple imputation taking into account the reason of missingness"||0.38|-1.25|0.232
72467795|NCT03599622|144458109|SUPERIORITY|Cochran-Mantel-Haenszel stratified by geographic region (US, Japan, Rest of World), prior exposure to tumor necrosis factor inhibitor (TNFi; Exposed/Naive), and concomitant corticosteroid use (Yes/No).|Risk Difference (RD)|-4.2||||0.5417|TWO_SIDED|95.0|-17.6|9.2||Based on a 2-sided test at a significance level of 0.025.|Mantel Haenszel||6 mg BMS-986165 (numerator) vs Placebo (denominator)|||9.2|-17.6|0.5417
72467796|NCT03599622|144458109|SUPERIORITY|Cochran-Mantel-Haenszel stratified by geographic region (US, Japan, Rest of World), prior exposure to tumor necrosis factor inhibitor (TNFi; Exposed/Naive), and concomitant corticosteroid use (Yes/No).|Odds Ratio (OR)|0.8||||0.5417|TWO_SIDED|95.0|0.3|1.8||Based on a 2-sided test at a significance level of 0.025.|Mantel Haenszel||6 mg BMS-986165 (numerator) vs Placebo (denominator)|||1.8|0.3|0.5417
72467797|NCT03599622|144458110|EQUIVALENCE|Mean Change From Baseline|Mean Difference (Final Values)|-3.0|STANDARD_ERROR_OF_MEAN|0.65|||TWO_SIDED|95.0|-4.3|-1.8|||ANCOVA|||||-1.8|-4.3|
72467798|NCT03599622|144458110|SUPERIORITY|Adjusted means, 95% confidence intervals, and p-values are from an analysis of covariance model with factors for geographic region, prior exposure to tumor necrosis factor inhibitor, and concomitant corticosteroid use, and the baseline value as a covariate.|Mean Difference (Final Values)|-1.9|STANDARD_ERROR_OF_MEAN|0.92||0.0428|TWO_SIDED|95.0|-3.7|-0.1||Based on a 2-sided test at a significance level of 0.025.|ANCOVA||3 mg BMS-986165 (numerator) vs Placebo (denominator)|||-0.1|-3.7|0.0428
72467799|NCT03599622|144458110|EQUIVALENCE|Mean Change from Baseline|Mean Difference (Final Values)|-3.4|STANDARD_ERROR_OF_MEAN|0.7|||TWO_SIDED|95.0|-4.8|-2.0|||ANCOVA|||||-2.0|-4.8|
72467800|NCT03599622|144458110|SUPERIORITY|Adjusted means, 95% confidence intervals, and p-values are from an analysis of covariance model with factors for geographic region, prior exposure to tumor necrosis factor inhibitor, and concomitant corticosteroid use, and the baseline value as a covariate.|Mean Difference (Final Values)|-2.3|STANDARD_ERROR_OF_MEAN|0.95||0.0177|TWO_SIDED|95.0|-4.1|-0.4||Based on a 2-sided test at a significance level of 0.025.|ANCOVA||6 mg BMS-986165 (numerator) vs Placebo (denominator)|||-0.4|-4.1|0.0177
72467801|NCT03599622|144458110|EQUIVALENCE|Mean Change From Baseline|Mean Difference (Final Values)|-1.2|STANDARD_ERROR_OF_MEAN|0.75|||TWO_SIDED|95.0|-2.6|0.3||||||||0.3|-2.6|
72467802|NCT03599622|144458110|EQUIVALENCE|Mean Change from Baseline|Mean Difference (Final Values)|-6.0|STANDARD_ERROR_OF_MEAN|1.88|||TWO_SIDED|95.0|-9.7|-2.3|||ANCOVA|||||-2.3|-9.7|
72467803|NCT02143063|144458135|SUPERIORITY||comparison of rank sum|3752.0||||0.01|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.01
72467804|NCT02143063|144458135|SUPERIORITY||comparison of rank sum|5287.5||||0.78|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.78
72467805|NCT02143063|144458136|SUPERIORITY||comparison of rank sum|3675.5||||0.02|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Primary Aim 1: Compare the standard care and standard care plus traditional CM conditions||||.02
72467806|NCT02143063|144458136|SUPERIORITY||comparison of rank sum|5189.5||||0.61|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.61
72467807|NCT00623363|144458143|SUPERIORITY|||||||0.503|||||||Monte Carlo estimates|||Baseline (Day -7)||||0.503
72467808|NCT00623363|144458143|SUPERIORITY||Least Squares (LS) Mean|20.6|||||TWO_SIDED|95.0|1.82|39.37||||||Average of Days 1 and 2||39.37|1.82|
72467809|NCT00623363|144458143|SUPERIORITY||Least Squares (LS) Mean|3.6|||||TWO_SIDED|95.0|-15.18|22.37||||||Change from Baseline||22.37|-15.18|
72467810|NCT00623363|144458143|SUPERIORITY||Least Squares (LS) Mean|36.59|||||TWO_SIDED|95.0|24.04|49.14||||||Average of Days 1 and 2||49.14|24.04|
72467811|NCT00623363|144458143|SUPERIORITY||Least Squares (LS) Mean|19.59||||0.16|TWO_SIDED|95.0|7.04|32.14|||ANCOVA|||Change from Baseline||32.14|7.04|0.160
72504032|NCT01025336|144539187|SUPERIORITY_OR_OTHER||Geometric mean fold rise|1.7|||||TWO_SIDED|95.0|1.31|2.18|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 7F: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||2.18|1.31|
72504033|NCT01025336|144539187|SUPERIORITY_OR_OTHER||Geometric mean fold rise|1.9|||||TWO_SIDED|95.0|1.37|2.61|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 9V: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||2.61|1.37|
72467812|NCT01130168|144458162|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.1|||<|0.0005|TWO_SIDED|95.0|-15.3|-10.9|||ANOVA|||||-10.9|-15.3|<0.0005
72467813|NCT01130168|144458162|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.7||||0.016|TWO_SIDED|95.0|-4.9|-0.6|||ANOVA|||||-0.6|-4.9|0.016
72467814|NCT01130168|144458163|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.3||||0.407|TWO_SIDED|95.0|-1.7|4.3|||ANOVA|||||4.3|-1.7|0.407
72467815|NCT01130168|144458163|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.9|||<|0.0005|TWO_SIDED|95.0|-8.9|-2.9|||ANOVA|||||-2.9|-8.9|<0.0005
72467816|NCT01130168|144458164|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.4|||<|0.0005|TWO_SIDED|95.0|-21.2|-10.1|||ANOVA|||||-10.1|-21.2|<0.0005
72467817|NCT01130168|144458164|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.3||||0.001|TWO_SIDED|95.0|-17.4|-6.3|||ANOVA|||||-6.3|-17.4|0.001
72467818|NCT01130168|144458165|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.8||||0.186|TWO_SIDED|95.0|-9.5|1.8|||ANOVA|||||1.8|-9.5|0.186
72467819|NCT01130168|144458165|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.1|||<|0.0005|TWO_SIDED|95.0|-21.7|-10.5|||ANOVA|||||-10.5|-21.7|<0.0005
72467820|NCT01130168|144458166|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-9.2|||<|0.0005|TWO_SIDED|95.0|-12.1|-6.4|||ANOVA|||||-6.4|-12.1|<0.0005
72467821|NCT01130168|144458166|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.5||||0.035|TWO_SIDED|95.0|-6.0|-0.3|||ANOVA|||||-0.3|-6.0|0.035
72467822|NCT01130168|144458167|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.8||||0.428|TWO_SIDED|95.0|-6.1|2.6|||ANOVA|||||2.6|-6.1|0.428
72467823|NCT01130168|144458167|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.8|||<|0.0005|TWO_SIDED|95.0|-13.1|-4.5|||ANOVA|||||-4.5|-13.1|<0.0005
72467824|NCT01130168|144458168|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.7|||<|0.0005|TWO_SIDED|95.0|-17.5|-10.0|||ANOVA|||||-10.0|-17.5|<0.0005
72467825|NCT01130168|144458168|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.8||||0.015|TWO_SIDED|95.0|-8.5|-1.0|||ANOVA|||||-1.0|-8.5|0.015
72467826|NCT01130168|144458169|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.4||||0.112|TWO_SIDED|95.0|-9.9|1.0|||ANOVA|||||1.0|-9.9|0.112
72467827|NCT01130168|144458169|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.3|||<|0.0005|TWO_SIDED|95.0|-20.7|-9.8|||ANOVA|||||-9.8|-20.7|<0.0005
72504034|NCT01025336|144539187|SUPERIORITY_OR_OTHER||Geometric mean fold rise|2.4|||||TWO_SIDED|95.0|1.76|3.38|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 9V: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||3.38|1.76|
72504035|NCT01025336|144539187|SUPERIORITY_OR_OTHER||Geometric mean fold rise|1.6|||||TWO_SIDED|95.0|1.33|1.86|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 14: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||1.86|1.33|
72564838|NCT00536484|144661173|SUPERIORITY_OR_OTHER|||||||0.0006||95.0||||Significance level p \<0.05|Cochran-Mantel-Haenszel|The CMH test used modified ridit scores which were based on the ranks of the observations rather than the observed values.||Treatment difference at Week 12||||0.0006
72467828|NCT01130168|144458170|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.0|||<|0.0005|TWO_SIDED|95.0|-11.8|-6.2|||ANOVA|||||-6.2|-11.8|<0.0005
72467829|NCT01130168|144458170|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.0||||0.039|TWO_SIDED|95.0|-5.8|-0.2|||ANOVA|||||-0.2|-5.8|0.039
72467830|NCT01130168|144458171|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.4||||0.267|TWO_SIDED|95.0|-6.6|1.8|||ANOVA|||||1.8|-6.6|0.267
72467831|NCT01130168|144458171|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.5|||<|0.0005|TWO_SIDED|95.0|-12.7|-4.3|||ANOVA|||||-4.3|-12.7|<0.0005
72467832|NCT00859976|144458172|SUPERIORITY|A superiority test was used to calculate the number of patients that are needed in order to show a difference between the bone mineral density surrounding BoneMaster coated cups compared to plasma HA sprayed cups.||||||0.457|||||||Wilcoxon (Mann-Whitney)|Change in bone mineral density, normalised to baseline levels.||||||0.4570
72467833|NCT01702519|144458195|NON_INFERIORITY_OR_EQUIVALENCE|Bio-equivalence was established if 90% confidence interval (CI) of the ratio (Test/Ref) of geometric means was included in the limit of 0.80 - 1.25|Treatment Ratio|0.946|||||TWO_SIDED|90.0|0.912|0.982|||Treatment Ratio||The ratio between the geometric means of the test and reference formulations was calculated|Null hypothesis considered no difference between the two treatments.||0.982|0.912|
72467834|NCT01702519|144458196|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was established if 90% confidence interval (CI) of the ratio (Test/Ref) of geometric means was included in the limit of 0.80 - 1.25.|Treatment Ratio|0.962|||||TWO_SIDED|90.0|0.92|1.0|||Treatment Ratio||The ratio between the geometric means of the test and reference formulations was calculated|Null hypothesis considered no difference between the treatments.||1.00|0.92|
72467835|NCT03738397|144458201|SUPERIORITY||Adjusted Response Rate Difference|9.7||||0.007|TWO_SIDED|95.0|2.6|16.7||A multiple testing procedure was used to provide a strong control of the type I error rate at alpha = 0.05 (2-sided) across analyses comparing upadacitinib versus dupilumab with respect to the primary and ranked secondary endpoints.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for vIGA-AD categories (moderate \[3\] versus severe \[4\]).|Response rate difference = Upadacitinib - Dupilumab|||16.7|2.6|0.007
72467836|NCT03738397|144458202|SUPERIORITY||Least Squares (LS) Mean Difference|-18.21|STANDARD_ERROR_OF_MEAN|2.753|<|0.001|TWO_SIDED|95.0|-23.61|-12.8||A multiple testing procedure was used to provide a strong control of the type I error rate at alpha = 0.05 (2-sided) across analyses comparing upadacitinib versus dupilumab with respect to the primary and ranked secondary endpoints.|Mixed Effect Model Repeated Measurement|Mixed-effect model repeat measurement with Baseline, treatment, visit, treatment by visit interaction, and Baseline vIGA-AD categories in the model.|Difference = Upadacitinib - Dupilumab|||-12.80|-23.61|<0.001
72467837|NCT03738397|144458203|SUPERIORITY||Adjusted Response Rate Difference|20.4|||<|0.001|TWO_SIDED|95.0|14.8|26.0||A multiple testing procedure was used to provide a strong control of the type I error rate at alpha = 0.05 (2-sided) across analyses comparing upadacitinib versus dupilumab with respect to the primary and ranked secondary endpoints.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for vIGA-AD categories (moderate \[3\] versus severe \[4\]).|Response rate difference = Upadacitinib - Dupilumab|||26.0|14.8|<0.001
72467838|NCT03738397|144458204|SUPERIORITY||Adjusted Response Rate Difference|21.2|||<|0.001|TWO_SIDED|95.0|13.8|28.6||A multiple testing procedure was used to provide a strong control of the type I error rate at alpha = 0.05 (2-sided) across analyses comparing upadacitinib versus dupilumab with respect to the primary and ranked secondary endpoints.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for vIGA-AD categories (moderate \[3\] versus severe \[4\]).|Response rate difference = Upadacitinib - Dupilumab|||28.6|13.8|<0.001
72467839|NCT03738397|144458205|SUPERIORITY||LS Mean Difference|-28.02|STANDARD_ERROR_OF_MEAN|3.177|<|0.001|TWO_SIDED|95.0|-34.25|-21.78||A multiple testing procedure was used to provide a strong control of the type I error rate at alpha = 0.05 (2-sided) across analyses comparing upadacitinib versus dupilumab with respect to the primary and ranked secondary endpoints.|Mixed Effect Model Repeated Measurement|Mixed-effect model repeat measurement with Baseline, treatment, visit, treatment by visit interaction, and Baseline vIGA-AD categories in the model.|Difference = Upadacitinib - Dupilumab|||-21.78|-34.25|<0.001
72564839|NCT00536484|144661174|SUPERIORITY_OR_OTHER|||||||0.0129||95.0||||Significance level p \<0.05|Cochran-Mantel-Haenszel|The CMH test used modified ridit scores which were based on the ranks of the observations rather than the observed values.||Treatment difference at Week 2||||0.0129
72564840|NCT00536484|144661174|SUPERIORITY_OR_OTHER|||||||0.01||95.0||||Significance level p \<0.05|Cochran-Mantel-Haenszel|The CMH test used modified ridit scores which were based on the ranks of the observations rather than the observed values.||Treatment difference at Week 6||||0.0100
72564841|NCT00536484|144661174|SUPERIORITY_OR_OTHER|||||||0.0009||95.0||||Significance level p \<0.05|Cochran-Mantel-Haenszel|The CMH test used modified ridit scores which were based on the ranks of the observations rather than the observed values.||Treatment difference at Week 12||||0.0009
72467840|NCT03738397|144458206|SUPERIORITY||Adjusted Response Rate Difference|26.0|||<|0.001|TWO_SIDED|95.0|19.3|32.7||A multiple testing procedure was used to provide a strong control of the type I error rate at alpha = 0.05 (2-sided) across analyses comparing upadacitinib versus dupilumab with respect to the primary and ranked secondary endpoints.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for vIGA-AD categories (moderate \[3\] versus severe \[4\]).|Response rate difference = Upadacitinib - Dupilumab|||32.7|19.3|<0.001
72467841|NCT03738397|144458207|SUPERIORITY||LS Mean Difference|-23.02|STANDARD_ERROR_OF_MEAN|2.548|<|0.001|TWO_SIDED|95.0|-28.03|-18.02||A multiple testing procedure was used to provide a strong control of the type I error rate at alpha = 0.05 (2-sided) across analyses comparing upadacitinib versus dupilumab with respect to the primary and ranked secondary endpoints.|Mixed Effect Model Repeated Measurement|Mixed-effect model repeat measurement with Baseline, treatment, visit, treatment by visit interaction, and Baseline vIGA-AD categories in the model.|Difference = Upadacitinib - Dupilumab|||-18.02|-28.03|<0.001
72467842|NCT03738397|144458208|SUPERIORITY||Adjusted Response Rate Difference|19.8|||<|0.001|TWO_SIDED|95.0|12.4|27.3||A multiple testing procedure was used to provide a strong control of the type I error rate at alpha = 0.05 (2-sided) across analyses comparing upadacitinib versus dupilumab with respect to the primary and ranked secondary endpoints.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for vIGA-AD categories (moderate \[3\] versus severe \[4\]).|Response rate difference = Upadacitinib - Dupilumab|||27.3|12.4|<0.001
72467843|NCT01795859|144458209|SUPERIORITY_OR_OTHER||LSMean Difference|-2.49|||<|0.0001|TWO_SIDED|95.0|-3.69|-1.29|||ANCOVA|||||-1.29|-3.69|<0.0001
72467844|NCT01795859|144458210|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|31.1||||0.002|TWO_SIDED|95.0|12.4|49.8|||Difference of proportions|||||49.8|12.4|0.0020
72467845|NCT01795859|144458211|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|28.9||||0.0022|TWO_SIDED|95.0|11.4|46.4|||Difference of proportions|||||46.4|11.4|0.0022
72467846|NCT01795859|144458212|SUPERIORITY_OR_OTHER||LSMean Difference|4.34||||0.0308|TWO_SIDED|95.0|0.41|8.27|||Mixed Models Analysis|||||8.27|0.41|0.0308
72467847|NCT01795859|144458213|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.0||||0.1415|TWO_SIDED|95.0|-0.3|2.3|||Mixed Models Analysis|||||2.3|-0.3|0.1415
72467848|NCT00984698|144458235|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Mixed Models Analysis|||Analysis must be qualified by small sample size, worse baseline symptom severity in CBSRT arm, and greater levels of attrition in PCGT arm||||<.05
72467849|NCT00984698|144458236|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Mixed Models Analysis|||Analysis must be qualified by small sample size, worse baseline symptom severity in CBSRT arm, and greater levels of attrition in PCGT arm||||<.05
72467850|NCT03448536|144458262|SUPERIORITY||LS Means Difference|4.31|||<|0.001|TWO_SIDED|95.0|2.06|6.56|||ANCOVA|||||6.56|2.06|< 0.001
72467851|NCT03448536|144458263|SUPERIORITY||LS Means Difference|9.8|||<|0.001|TWO_SIDED|95.0|5.75|13.85|||ANCOVA|||||13.85|5.75|< 0.001
72467852|NCT03448536|144458264|SUPERIORITY||LS Means Difference|1.52|||=|0.129|TWO_SIDED|95.0|-0.45|3.49|||ANCOVA|||||3.49|-0.45|= 0.129
72467853|NCT03448536|144458265|SUPERIORITY||LS Means Difference|8.27|||<|0.001|TWO_SIDED|95.0|5.76|10.78|||ANCOVA|||||10.78|5.76|< 0.001
72467854|NCT03448536|144458266|SUPERIORITY||LS Means Difference|0.56|||=|0.307|TWO_SIDED|95.0|-0.52|1.64|||ANCOVA|||||1.64|-0.52|= 0.307
72467855|NCT03448536|144458267|SUPERIORITY||LS Means Difference|3.75|||<|0.001|TWO_SIDED|95.0|2.34|5.16|||ANCOVA|||||5.16|2.34|< 0.001
72467856|NCT03448536|144458268|SUPERIORITY||||||<|0.001|||||||Log Rank|||||||< 0.001
72564842|NCT00536484|144661175|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001||95.0|-0.9|-0.4||Significance level p \<0.05|ANCOVA|Terms for center, treatment and baseline covariate||Week 2 minus Baseline||-0.4|-0.9|<0.0001
72564843|NCT00536484|144661175|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001||95.0|-1.1|-0.5||Significance level p \<0.05|ANCOVA|Terms for center, treatment and baseline covariate||Week 6 minus Baseline||-0.5|-1.1|<0.0001
72564844|NCT00536484|144661175|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001||95.0|-1.3|-0.7||Significance level p \<0.05|ANCOVA|Terms for center, treatment and baseline covariate||Week 12 minus Baseline||-0.7|-1.3|<0.0001
72564845|NCT01506908|144661176|SUPERIORITY_OR_OTHER||Least squares means difference|-15.9|||<|0.0001|TWO_SIDED|95.0|-21.6|-10.2|||ANCOVA||Treatment comparisons were made between 4 mg nicotine lozenge and placebo lozenge at 5% significance level.|Null hypothesis considered the population's change from post-cue baseline in craving score mean to be equal in both treatment groups at 5 minutes||-10.2|-21.6|<0.0001
72467857|NCT03448536|144458270|SUPERIORITY||||||=|0.002|||||||Cochran-Mantel-Haenszel|||||||= 0.002
72467858|NCT03783546|144458272|SUPERIORITY|||||||0.0003|||||||Mixed Models Analysis|||||||0.0003
72467859|NCT03783546|144458274|SUPERIORITY|||||||0.002|||||||Mixed Models Analysis|||||||0.002
72467860|NCT00497874|144458287|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Power analysis shows that sample size provided power of at least .80 to detect estimated differences.||||||0.003||95.0||||Statistical significance of the pooled results was evaluated using a t-test and degrees of freedom that take into account the uncertainty in the data and the uncertainty due to missing values.|t-test, 1 sided|t(145) = 2.8||Multiple imputation was used to estimate missing data for the 9-month assessment. Ten datasets were imputed using Multivariate Imputation by Chained Equations. Using SAS v9.1 PROC MI, the complete datasets were analyzed using complete data methodology-in this case, the t-test-and the results pooled.||||.003
72467861|NCT00497874|144458288|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Power analysis shows that sample size provided power of at least .80 to detect estimated differences.||||||0.002||95.0||||Statistical significance of the pooled results was evaluated using a t-test and degrees of freedom that take into account the uncertainty in the data and the uncertainty due to missing values.|t-test, 1 sided|t(181) = 2.9||Multiple imputation was used to estimate missing data for the 9-month assessment. Ten datasets were imputed using Multivariate Imputation by Chained Equations. Using SAS v9.1 PROC MI, the complete datasets were analyzed using complete data methodology-in this case, logistic regression-and the results pooled.||||.002
72467862|NCT00497874|144458289|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Power analysis shows that sample size provided power of at least .80 to detect estimated differences.||||||0.04||95.0||||Statistical significance of the pooled results was evaluated using a t-test and degrees of freedom that take into account the uncertainty in the data and the uncertainty due to missing values.|t-test, 1 sided|t(153) = 1.8||Multiple imputation was used to estimate missing data for the 9-month assessment. Ten datasets were imputed using Multivariate Imputation by Chained Equations. Using SAS v9.1 PROC MI, the complete datasets were analyzed using complete data methodology-in this case, logistic regression-and the results pooled.||||.04
72467863|NCT00497874|144458290|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Power analysis shows that sample size provided power of at least .80 to detect estimated differences.||||||0.07||95.0||||Statistical significance of the pooled results was evaluated using a t-test and degrees of freedom that take into account the uncertainty in the data and the uncertainty due to missing values.|t-test, 1 sided|t(57) = 1.5||Multiple imputation was used to estimate missing data for the 9-month assessment. Ten datasets were imputed using Multivariate Imputation by Chained Equations. Using SAS v9.1 PROC MI, the complete datasets were analyzed using complete data methodology-in this case, logistic regression-and the results pooled.||||.07
72467864|NCT00497874|144458291|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Power analysis shows that sample size provided power of at least .80 to detect estimated differences.||||||0.05||95.0|||||t-test, 1 sided|t(94) = 1.5||Multiple imputation was used to estimate missing data for the 9-month assessment. Ten datasets were imputed using Multivariate Imputation by Chained Equations. Using SAS v9.1 PROC MI, the complete datasets were analyzed using complete data methodology-in this case, logistic regression-and the results pooled.||||.05
72467865|NCT00497874|144458292|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Power analysis shows that sample size provided power of at least .80 to detect estimated differences.||||||0.13||95.0||||Statistical significance of the pooled results was evaluated using a t-test and degrees of freedom that take into account the uncertainty in the data and the uncertainty due to missing values.|t-test, 1 sided|t(123) = 1.2||Multiple imputation was used to estimate missing data for the 9-month assessment. Ten datasets were imputed using Multivariate Imputation by Chained Equations. Using SAS v9.1 PROC MI, the complete datasets were analyzed using complete data methodology-in this case, the t-test-and the results pooled.||||.13
72467866|NCT02330276|144458293|SUPERIORITY_OR_OTHER|||||||0.05||||||The reported P-Value was calculated|General linear mixed-effects models|||||||0.05
72504036|NCT01025336|144539187|SUPERIORITY_OR_OTHER||Geometric mean fold rise|1.7|||||TWO_SIDED|95.0|1.38|2.01|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 14: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||2.01|1.38|
72504037|NCT01025336|144539187|SUPERIORITY_OR_OTHER||Geometric mean fold rise|1.3|||||TWO_SIDED|95.0|1.1|1.42|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 18C: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||1.42|1.10|
72621877|NCT02579759|144774073|SUPERIORITY||Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.31||0.868|TWO_SIDED|97.5|-0.74|0.64|||ANCOVA|||"The main analysis was performed as follows:~1. Analysis population: modified Full Analysis Set (mFAS)~2. Statistical model: ANCOVA where the mean at 12 and 15 months of each treatment group was compared against the placebo group, adjusting for the baseline value and assuming centre as a random effect~3. Missing value imputation: multiple imputation taking into account the reason of missingness"||0.64|-0.74|0.868
72504038|NCT01025336|144539187|SUPERIORITY_OR_OTHER||Geometric mean fold rise|1.3|||||TWO_SIDED|95.0|1.14|1.55|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 18C: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||1.55|1.14|
72504039|NCT01025336|144539187|SUPERIORITY_OR_OTHER||Geometric mean fold rise|1.3|||||TWO_SIDED|95.0|1.14|1.43|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 19A: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||1.43|1.14|
72504040|NCT01025336|144539187|SUPERIORITY_OR_OTHER||Geometric mean fold rise|1.5|||||TWO_SIDED|95.0|1.28|1.67|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 19A: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||1.67|1.28|
72504041|NCT01025336|144539187|SUPERIORITY_OR_OTHER||Geometric mean fold rise|2.2|||||TWO_SIDED|95.0|1.8|2.6|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 19F: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||2.60|1.80|
72504042|NCT01025336|144539187|SUPERIORITY_OR_OTHER||Geometric mean fold rise|1.9|||||TWO_SIDED|95.0|1.53|2.31|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 19F: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||2.31|1.53|
72467867|NCT02330276|144458294|OTHER|one way ANOVA between groups|Mean Difference (Final Values)|77.9|STANDARD_DEVIATION|11.9|<|0.05|TWO_SIDED|95.0|70.3|85.5||for change in heart rate at 24 hr post-dosing from baseline between the 3 doses|ANOVA|||Primary hypothesis: None of the doses of (+)-epicatechin will differ with regard to change from baseline in any of the major safety endpoints; heart rate, systolic and diastolic blood pressure.||85.5|70.3|<0.05
72564846|NCT01506908|144661177|SUPERIORITY_OR_OTHER||Least squares means difference|-4.2||||0.0511|TWO_SIDED|95.0|-8.4|0.0|||ANCOVA||Treatment comparisons were made between 4 mg nicotine lozenge and placebo lozenge at 5% significance level.|Null hypothesis considered the population's change from post-cue baseline in craving score mean to be equal in both treatment groups at 1 minute.||0.0|-8.4|0.0511
72467868|NCT02330276|144458295|SUPERIORITY_OR_OTHER|||||||0.05||||||The reported P-Value was calculated|General linear mixed-effects models|||||||0.05
72467869|NCT02330276|144458296|SUPERIORITY_OR_OTHER|||||||0.05||||||The reported P-Value was calculated|General linear mixed-effects models|||||||0.05
72467870|NCT02330276|144458297|SUPERIORITY_OR_OTHER|||||||0.05||||||The reported P-Value was calculated|General linear mixed-effects models|||||||0.05
72467871|NCT00004146|144458352|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.85||||0.1|TWO_SIDED|95.0|0.65|1.12|||t-test, 1 sided|||the study design is to detect 30% reduction in hazard of deaths with 78% power at one side alpha level of 0.10. Overall survial time was calculated from time of histological diagnosis until time of death from any event.||1.12|0.65|0.10
72467872|NCT02808975|144458355|SUPERIORITY||||||=|0.049|||||||Cochran-Mantel-Haenszel|Across all strata, P-value calculated from Cochran-Mantel-Haenszel test adjusted for strata. Stratum containing zero count: 0.1 added to each cell.||||||=0.049
72467873|NCT02808975|144458356|SUPERIORITY||||||=|0.067|||||||Cochran-Mantel-Haenszel|Across all strata, P-value calculated from Cochran-Mantel-Haenszel test adjusted for strata. Stratum containing zero count: 0.1 added to each cell.||||||=0.067
72467874|NCT02808975|144458357|SUPERIORITY||||||=|0.003|||||||Cochran-Mantel-Haenszel|Across all strata, P-value calculated from Cochran-Mantel-Haenszel test adjusted for strata. Stratum containing zero count: 0.1 added to each cell.||||||=0.003
72564847|NCT01506908|144661178|SUPERIORITY_OR_OTHER||Least squares means difference|-11.6|||<|0.0001|TWO_SIDED|95.0|-16.7|-6.4|||ANCOVA||Treatment comparisons were made between 4 mg nicotine lozenge and placebo lozenge at 5% significance level.|Null hypothesis considered the population's change from post-cue baseline in craving score mean to be equal in both treatment groups at 3 minutes.||-6.4|-16.7|<0.0001
72564848|NCT01506908|144661179|SUPERIORITY_OR_OTHER||Least squares means difference|-17.8|||<|0.0001|TWO_SIDED|95.0|-23.8|-11.7|||ANCOVA||Treatment comparisons were made between 4 mg nicotine lozenge and placebo lozenge at 5% significance level.|Null hypothesis considered the population's change from post-cue baseline in craving score mean to be equal in both treatment groups at 7 minutes.||-11.7|-23.8|<0.0001
72564849|NCT01506908|144661180|SUPERIORITY_OR_OTHER||Least square mean difference|-17.9|||<|0.0001|TWO_SIDED|95.0|-24.4|-11.4|||ANCOVA||Treatment comparisons were made between 4 mg nicotine lozenge and placebo lozenge at 5% significance level.|Null hypothesis considered the population's change from post-cue baseline in craving score mean to be equal in both treatment groups at 10 minutes.||-11.4|-24.4|<0.0001
72467875|NCT02808975|144458358|SUPERIORITY||||||=|0.313|||||||ANCOVA|Across all strata, P-values are calculated from ANCOVA with stratum, baseline value, and treatment in the model.||||||=0.313
72467876|NCT02808975|144458359|SUPERIORITY||||||=|0.746|||||||Cochran-Mantel-Haenszel|Across all strata, P-value calculated from Cochran-Mantel-Haenszel test adjusted for strata. Stratum containing zero count: 0.1 added to each cell.||||||=0.746
72467877|NCT04702893|144458449|OTHER|No formal hypotheses were tested.||||||0.1185|||||||Z-test of correlation|||||||0.1185
72467878|NCT04702893|144458450|OTHER|No formal hypotheses were tested.||||||0.5135|||||||Z-test of correlation|||||||0.5135
72467879|NCT04702893|144458451|OTHER|No formal hypotheses were tested.||||||0.0764|||||||Z-test of correlation|||||||0.0764
72467880|NCT04702893|144458452|OTHER|No formal hypotheses were tested.||||||0.3478|||||||Z-test of correlation|||||||0.3478
72467881|NCT00816556|144458463|SUPERIORITY_OR_OTHER|||||||0.42|||||||ANOVA|||Dryness severity: P-value for the global F-test testing for all treatment arm effects equal.||||0.42
72467882|NCT00816556|144458463|SUPERIORITY_OR_OTHER|||||||0.22|||||||ANOVA|||Dryness bothersomeness: P-value for the global F-test testing for all treatment arm effects equal.||||0.22
72467883|NCT00816556|144458463|SUPERIORITY_OR_OTHER|||||||0.37|||||||ANOVA|||Itching severity: P-value for the global F-test testing for all treatment arm effects equal.||||0.37
72467884|NCT00816556|144458463|SUPERIORITY_OR_OTHER|||||||0.27|||||||ANOVA|||Itching bothersomeness: P-value for the global F-test testing for all treatment arm effects equal.||||0.27
72467885|NCT00816556|144458463|SUPERIORITY_OR_OTHER|||||||0.46|||||||ANOVA|||Burning severity: P-value for the global F-test testing for all treatment arm effects equal.||||0.46
72467886|NCT00816556|144458463|SUPERIORITY_OR_OTHER|||||||0.67|||||||ANOVA|||Burning bothersomeness: P-value for the global F-test testing for all treatment arm effects equal.||||0.67
72467887|NCT00816556|144458464|SUPERIORITY_OR_OTHER|||||||0.33|||||||ANOVA|||Baseline vs. week 2: P-value for the global F-test testing for all treatment arm effects equal.||||0.33
72467888|NCT00816556|144458464|SUPERIORITY_OR_OTHER|||||||0.99|||||||ANOVA|||Baseline vs. week 12: P-value for the global F-test testing for all treatment arm effects equal.||||0.99
72467889|NCT00816556|144458464|SUPERIORITY_OR_OTHER|||||||0.58|||||||ANOVA|||Week 2 vs. week 12: P-value for the global F-test testing for all treatment arm effects equal.||||0.58
72467890|NCT00816556|144458465|SUPERIORITY_OR_OTHER|||||||0.007|||||||ANOVA|||Baseline vs. week 2: P-value for the global F-test testing for all treatment arm effects equal.||||0.007
72467891|NCT00816556|144458465|SUPERIORITY_OR_OTHER|||||||0.32|||||||ANOVA|||Baseline vs. week 12: P-value for the global F-test testing for all treatment arm effects equal.||||0.32
72467892|NCT00816556|144458465|SUPERIORITY_OR_OTHER|||||||0.02|||||||ANOVA|||Week 2 vs. week 12: P-value for the global F-test testing for all treatment arm effects equal.||||0.02
72467893|NCT03546816|144458466|SUPERIORITY|||||||0.229||||||P-value from a Cochran-Mantel-Haenszel (CMH) test stratified by Baseline WI-NRS used for randomization stratification. Value has been adjusted for multiple imputation.|Cochran-Mantel-Haenszel|||||||0.229
72467894|NCT03546816|144458467|SUPERIORITY|||||||0.013||||||P-value from a CMH test stratified by Baseline WI-NRS used for randomization stratification. Value has been adjusted for multiple imputation.|Cochran-Mantel-Haenszel|||||||0.013
72504043|NCT01025336|144539187|SUPERIORITY_OR_OTHER||Geometric mean fold rise|1.7|||||TWO_SIDED|95.0|1.44|2.06|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 23F: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||2.06|1.44|
72504044|NCT01025336|144539187|SUPERIORITY_OR_OTHER||Geometric mean fold rise|1.5|||||TWO_SIDED|95.0|1.24|1.84|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 23F: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||1.84|1.24|
72504045|NCT01025336|144539188|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.2|||||TWO_SIDED|95.0|0.19|0.29|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 1: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.29|0.19|
72504046|NCT01025336|144539188|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.2|||||TWO_SIDED|95.0|0.17|0.25|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 1: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.25|0.17|
72504047|NCT01025336|144539188|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.2|||||TWO_SIDED|95.0|0.2|0.29|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 1: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.29|0.20|
72504048|NCT01025336|144539188|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.2|||||TWO_SIDED|95.0|0.2|0.3|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 3: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.30|0.20|
72504049|NCT01025336|144539188|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.4|||||TWO_SIDED|95.0|0.31|0.42|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 3: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.42|0.31|
72504050|NCT01025336|144539188|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.2|||||TWO_SIDED|95.0|0.18|0.26|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 3: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.26|0.18|
72504051|NCT01025336|144539188|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.1|||||TWO_SIDED|95.0|0.1|0.18|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 4: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.18|0.10|
72504052|NCT01025336|144539188|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.2|||||TWO_SIDED|95.0|0.12|0.2|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 4: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.20|0.12|
72504053|NCT01025336|144539188|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.1|||||TWO_SIDED|95.0|0.1|0.18|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 4: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.18|0.10|
72564850|NCT03314662|144661182|NON_INFERIORITY|aQIV was considered non-inferior to aTIV-1 or aTIV-2 if the upper bound of the two-sided 95% confidence interval (CI) for the ratios of GMTs (aTIV/aQIV) do not exceed 1.5|GMT ratio (aTIV/aQIV)|1.16|||||TWO_SIDED|95.0|1.05|1.27|||||GMT ratios (adjusted) obtained from a GLM fitted on log-transformed (base 10) post-vaccination HI titer as outcome variable and covariate terms: treatment, pre-vaccination HI titer (log10 transformed), age, sex, vaccination history, study site|Comparison Group Selection: aTIV/aQIV - for strain A/H1N1||1.27|1.05|
72621878|NCT02579759|144774073|SUPERIORITY||Slope|-0.18|STANDARD_ERROR_OF_MEAN|0.18||0.322|TWO_SIDED|95.0|-0.53|0.17|||Regression, Linear|||"Dose is defined as a numerical variable proportional to quantity of PXT3003 administered (0 for Placebo, 1 for Dose 1, 2 for Dose 2).~The analysis was performed as follows:~1. Analysis population: modified Full Analysis Set (mFAS)~2. Statistical model: ANCOVA assessing the dose-effect at the mean of 12 and 15 months, adjusting for baseline value and assuming centre as random effect~3. Missing value imputation: multiple imputation taking into account the reason of missingness"||0.17|-0.53|0.322
72467895|NCT03546816|144458468|SUPERIORITY|||||||0.236||||||P-value from a CMH test stratified by Baseline WI-NRS used for randomization stratification. Value has been adjusted for multiple imputation.|Cochran-Mantel-Haenszel|||||||0.236
72467896|NCT03546816|144458469|SUPERIORITY|||||||0.083||||||P-values, least squares means (LS Mean) and standard deviations (LS SD) from an analysis of covariance (ANCOVA) with treatment group and stratification factor as fixed effects, and baseline value as a covariate.|ANCOVA|||At Week 2||||0.083
72467897|NCT03546816|144458469|SUPERIORITY|||||||0.049||||||P-values, LS mean and SD from ANCOVA with treatment group and stratification factor as fixed effects, and baseline value as a covariate.|ANCOVA|||At Week 4||||0.049
72564851|NCT03314662|144661182|NON_INFERIORITY|aQIV was considered non-inferior to aTIV-1 or aTIV-2 if the upper bound of the two-sided 95% confidence interval (CI) for the ratios of GMTs (aTIV/aQIV) do not exceed 1.5|GMT ratio: (aTIV/aQIV|0.99|||||TWO_SIDED|95.0|0.9|1.09|||||GMT ratios (adjusted) obtained from a GLM fitted on log-transformed (base 10) post-vaccination HI titer as outcome variable and covariate terms: treatment, pre-vaccination HI titer (log 10 transformed), age, sex, vaccination history, study site|Comparison Group Selection: aTIV/aQIV - performed for strain A/H3N2||1.09|0.90|
72564852|NCT03314662|144661182|NON_INFERIORITY|aQIV was considered non-inferior to aTIV-1 or aTIV-2 if the upper bound of the two-sided 95% confidence interval (CI) for the ratios of GMTs (aTIV/aQIV) do not exceed 1.5.|GMT ratio: aTIV/aQIV|0.99|||||TWO_SIDED|95.0|0.9|1.08|||||GMT ratios (adjusted) obtained from a GLM fitted on log-transformed (base 10) post-vaccination HI titer as outcome variable and covariate terms: treatment, pre-vaccination HI titer (log10 transformed), age, sex, vaccination history, study site|Comparison Group Selection: aQIV/aTIV - performed for strain B/Yamagata||1.08|0.90|
72467898|NCT03546816|144458469|SUPERIORITY|||||||0.081||||||P-values, LS mean and SD from ANCOVA with treatment group and stratification factor as fixed effects, and baseline value as a covariate.|ANCOVA|||At Week 6||||0.081
72467899|NCT03546816|144458469|SUPERIORITY|||||||0.157||||||P-values, LS mean and SD from ANCOVA with treatment group and stratification factor as fixed effects, and baseline value as a covariate.|ANCOVA|||At Week 10||||0.157
72467900|NCT03546816|144458470|SUPERIORITY|||||||0.151||||||P-value from a CMH test stratified by Baseline WI-NRS used for randomization stratification. Value has been adjusted for multiple imputation.|Cochran-Mantel-Haenszel|||At Week 2||||0.151
72467901|NCT03546816|144458470|SUPERIORITY|||||||0.052||||||P-value from a CMH test stratified by Baseline WI-NRS used for randomization stratification. Value has been adjusted for multiple imputation.|Cochran-Mantel-Haenszel|||At Week 4||||0.052
72467902|NCT03546816|144458470|SUPERIORITY|||||||0.175||||||P-value from a CMH test stratified by Baseline WI-NRS used for randomization stratification. Value has been adjusted for multiple imputation.|Cochran-Mantel-Haenszel|||At Week 10||||0.175
72467903|NCT03546816|144458471|SUPERIORITY|||||||0.475||||||P-values, LS mean and SD from ANCOVA with treatment group and stratification factor as fixed effects, and baseline value as a covariate.|ANCOVA|||At Week 2||||0.475
72467904|NCT03546816|144458471|SUPERIORITY|||||||0.02||||||P-values, LS mean and SD from ANCOVA with treatment group and stratification factor as fixed effects, and baseline value as a covariate.|ANCOVA|||At Week 4||||0.020
72467905|NCT03546816|144458471|SUPERIORITY|||||||0.492||||||P-values, LS mean and SD from ANCOVA with treatment group and stratification factor as fixed effects, and baseline value as a covariate.|ANCOVA|||At Week 10||||0.492
72467906|NCT03546816|144458472|SUPERIORITY|||||||0.175||||||P-values, LS mean and SD from ANCOVA with treatment group and stratification factor as fixed effects, and baseline value as a covariate.|ANCOVA|||At Week 2||||0.175
72467907|NCT03546816|144458472|SUPERIORITY|||||||0.169||||||P-values, LS mean and SD from ANCOVA with treatment group and stratification factor as fixed effects, and baseline value as a covariate.|ANCOVA|||At Week 4||||0.169
72467908|NCT03546816|144458472|SUPERIORITY|||||||0.516||||||P-values, LS mean and SD from ANCOVA with treatment group and stratification factor as fixed effects, and baseline value as a covariate.|ANCOVA|||At Week 10||||0.516
72467909|NCT03546816|144458473|SUPERIORITY|||||||0.814||||||P-values, LS mean and SD from ANCOVA with treatment group and stratification factor as fixed effects, and baseline value as a covariate.|ANCOVA|||At Week 10||||0.814
72467910|NCT03546816|144458474|SUPERIORITY|||||||0.113||||||P-values, LS mean and SD from ANCOVA with treatment group and stratification factor as fixed effects, and baseline value as a covariate.|ANCOVA|||At Week 10||||0.113
72467911|NCT01161446|144458504|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
72467912|NCT01161446|144458505|NON_INFERIORITY|Non-inferiority bound: Self-testing was to be considered non-inferior to standard testing if the upper bound of the 95% confidence interval for the odds ratio fell below 2.|Odds Ratio (OR)|1.07|||||TWO_SIDED|95.0|0.61|1.9|||Regression, Logistic|Used generalized estimating equations with exchangeable working correlation and robust standard errors to account for repeated measures.|The home testing arm represents the numerator and the standard testing arm the denominator.|||1.90|0.61|
72467913|NCT01161446|144458506|NON_INFERIORITY|Home testing was to be considered non-inferior to standard testing with respect to STI prevalence if the upper bound of the 95% confidence interval for the difference between the two arms (home - standard) fell below 10%.|Difference in proportions|-0.068|||||TWO_SIDED|95.0|-0.16|0.016||||||||0.016|-0.16|
72467914|NCT01161446|144458507|NON_INFERIORITY|Self-testing was to be considered non-inferior with respect to the number of reported male CAI partners if the upper bound of the 95% CI for the fold-difference in the number of partners between the two arms (self ÷ standard testing) fell below 2.|Incidence Rate Ratio|0.92|||||TWO_SIDED|95.0|0.64|1.33|||Poisson regression|Used generalized estimating equations with exchangeable working correlation and robust standard errors to account for repeated measures.|The home testing arm represents the numerator and the standard testing arm the denominator.|||1.33|0.64|
72467915|NCT01777126|144458517|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|3.0|||<|0.001|||||||Wilcoxon (Mann-Whitney)|||The primary outcome measure was the interval from surgery to discharge. Discharge means that the patient returns to his home. Preliminary data from our institution showed that all patients received parenteral nutrition very early post-surgery and were discharged after a mean of 19.3 ± 5.6 days. Therefore, the primary objective by implementing the ONP was to reduce the length of stay with 3 days.||||<0.001
72467916|NCT01777126|144458520|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|4.0|||<|0.01|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||Statistical analysis was performed by the Leuven Statistics Research Centre, KU Leuven, using SPSS package (SPSS Statistics 20.0 for Windows). Statistical analysis was performed using the Wilcoxon rank sum test. The result was considered statistically significant if p-values were \< 0.05.||||<0.01
72467917|NCT01777126|144458521|SUPERIORITY_OR_OTHER||proportion|||||0.487||95.0|||||Fisher Exact|||Statistical analysis was performed by the Leuven Statistics Research Centre, KU Leuven, using SPSS package (SPSS Statistics 20.0 for Windows). Statistical analysis was performed using Chi-square and Fisher's Exact Test. Results were considered statistically significant if p-values were \< 0.05.||||0.487
72467918|NCT01777126|144458522|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.302|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||0.302
72467919|NCT01777126|144458523|SUPERIORITY_OR_OTHER||Proportion|||||0.117|TWO_SIDED|95.0|||||Fisher Exact|||Statistical analysis was performed by the Leuven Statistics Research Centre, KU Leuven, using SPSS package (SPSS Statistics 20.0 for Windows). Statistical analysis was performed using Fisher's Exact Test. The result was considered statistically significant if p-values were \< 0.05.||||0.117
72467920|NCT01777126|144458524|SUPERIORITY_OR_OTHER||Proportion|||||0.049||95.0|||||Chi-squared|||Statistical analysis was performed by the Leuven Statistics Research Centre, KU Leuven, using SPSS package (SPSS Statistics 20.0 for Windows). Statistical analysis was performed using Chi-square Test. Outcome measures were considered statistically significant if p-values were \< 0.05.||||0.049
72467921|NCT01777126|144458525|SUPERIORITY_OR_OTHER||proportion|||||0.698||95.0|||||Chi-squared|||Statistical analysis was performed by the Leuven Statistics Research Centre, KU Leuven, using SPSS package (SPSS Statistics 20.0 for Windows). Statistical analysis was performed using Chi-square Test. Outcome measures were considered statistically significant if p-values were \< 0.05.||||0.698
72467922|NCT01192776|144458656|SUPERIORITY|Generalized Estimating Equations models with log link, adjusted for level of encephalopathy and intra-center correlations|Risk Ratio (RR)|1.23|||||TWO_SIDED|95.0|0.76|1.98||||||32.0°C for 72 hours vs. 33.5°C for 72 hours (33.5°C for 72 hours is the comparison group)||1.98|0.76|
72467923|NCT01192776|144458656|SUPERIORITY|Generalized Estimating Equations models with log link, adjusted for level of encephalopathy and intra-center correlations|Risk Ratio (RR)|1.21|||||TWO_SIDED|95.0|0.78|1.87||||||33.5°C for 120 hours vs. 33.5°C for 72 hours (33.5°C for 72 hours is the comparison group)||1.87|0.78|
72467924|NCT01192776|144458656|SUPERIORITY|Generalized Estimating Equations models with log link, adjusted for level of encephalopathy and intra-center correlations|Risk Ratio (RR)|0.85|||||TWO_SIDED|95.0|0.53|1.35||||||32.0°C for 120 hours vs. 33.5°C for 72 hours (33.5°C for 72 hours is the comparison group)||1.35|0.53|
72467925|NCT01192776|144458657|SUPERIORITY|Generalized Estimating Equations models with log link, adjusted for level of encephalopathy and intra-center correlations|Risk Ratio (RR)|2.16|||||TWO_SIDED|95.0|0.55|8.49||||||32.0°C for 72 hours vs. 33.5°C for 72 hours (33.5°C for 72 hours is the comparison group)||8.49|0.55|
72467926|NCT01192776|144458657|SUPERIORITY|Generalized Estimating Equations models with log link, adjusted for level of encephalopathy and intra-center correlations|Risk Ratio (RR)|2.52|||||TWO_SIDED|95.0|1.06|5.95||||||33.5°C for 120 hours vs. 33.5°C for 72 hours (33.5°C for 72 hours is the comparison group)||5.95|1.06|
72467927|NCT01192776|144458657|SUPERIORITY|Generalized Estimating Equations models with log link, adjusted for level of encephalopathy and intra-center correlations|Risk Ratio (RR)|1.85|||||TWO_SIDED|95.0|0.79|4.31||||||32.0°C for 120 hours vs. 33.5°C for 72 hours (33.5°C for 72 hours is the comparison group)||4.31|0.79|
72467928|NCT01192776|144458662|SUPERIORITY|Generalized Estimating Equations models with log link, adjusted for level of encephalopathy and intra-center correlations|Risk Ratio (RR)|1.23|||||TWO_SIDED|95.0|0.64|2.38||||||32.0°C for 72 hours vs. 33.5°C for 72 hours (33.5°C for 72 hours is the comparison group)||2.38|0.64|
72467929|NCT01192776|144458662|SUPERIORITY|Generalized Estimating Equations models with log link, adjusted for level of encephalopathy and intra-center correlations|Risk Ratio (RR)|0.82|||||TWO_SIDED|95.0|0.36|1.9||||||33.5°C for 120 hours vs. 33.5°C for 72 hours (33.5°C for 72 hours is the comparison group)||1.90|0.36|
72467930|NCT01192776|144458662|SUPERIORITY|Generalized Estimating Equations models with log link, adjusted for level of encephalopathy and intra-center correlations|Risk Ratio (RR)|0.64|||||TWO_SIDED|95.0|0.26|1.57||||||32.0°C for 120 hours vs. 33.5°C for 72 hours (33.5°C for 72 hours is the comparison group)||1.57|0.26|
72467931|NCT01192776|144458664|SUPERIORITY|Generalized Estimating Equations models with log link, adjusted for level of encephalopathy and intra-center correlations|Risk Ratio (RR)|1.33|||||TWO_SIDED|95.0|0.63|2.77||||||32.0°C for 72 hours vs. 33.5°C for 72 hours (33.5°C for 72 hours is the comparison group)||2.77|0.63|
72467932|NCT01192776|144458664|SUPERIORITY|Generalized Estimating Equations models with log link, adjusted for level of encephalopathy and intra-center correlations|Risk Ratio (RR)|0.42|||||TWO_SIDED|95.0|0.09|2.04||||||33.5°C for 120 hours vs. 33.5°C for 72 hours (33.5°C for 72 hours is the comparison group)||2.04|0.09|
72467933|NCT01192776|144458664|SUPERIORITY|Generalized Estimating Equations models with log link, adjusted for level of encephalopathy and intra-center correlations|Risk Ratio (RR)|0.78|||||TWO_SIDED|95.0|0.2|2.99||||||32.0°C for 120 hours vs. 33.5°C for 72 hours (33.5°C for 72 hours is the comparison group)||2.99|0.20|
72467934|NCT01192776|144458665|SUPERIORITY|Generalized Estimating Equations models with log link, adjusted for level of encephalopathy and intra-center correlations|Risk Ratio (RR)|0.65|||||TWO_SIDED|95.0|0.14|3.01||||||32.0°C for 72 hours vs. 33.5°C for 72 hours (33.5°C for 72 hours is the comparison group)||3.01|0.14|
72467935|NCT01192776|144458665|SUPERIORITY|Generalized Estimating Equations models with log link, adjusted for level of encephalopathy and intra-center correlations|Risk Ratio (RR)|1.31|||||TWO_SIDED|95.0|0.44|3.91||||||33.5°C for 120 hours vs. 33.5°C for 72 hours (33.5°C for 72 hours is the comparison group)||3.91|0.44|
72467936|NCT01192776|144458665|SUPERIORITY|Generalized Estimating Equations models with log link, adjusted for level of encephalopathy and intra-center correlations|Risk Ratio (RR)|0.28|||||TWO_SIDED|95.0|0.03|2.89||||||32.0°C for 120 hours vs. 33.5°C for 72 hours (33.5°C for 72 hours is the comparison group)||2.89|0.03|
72467937|NCT01192776|144458666|SUPERIORITY|Generalized Estimating Equations models with log link, adjusted for level of encephalopathy and intra-center correlations|Risk Ratio (RR)|0.87|||||TWO_SIDED|95.0|0.37|2.07||||||32.0°C for 72 hours vs. 33.5°C for 72 hours (33.5°C for 72 hours is the comparison group)||2.07|0.37|
72467938|NCT01192776|144458666|SUPERIORITY|Generalized Estimating Equations models with log link, adjusted for level of encephalopathy and intra-center correlations|Risk Ratio (RR)|0.64|||||TWO_SIDED|95.0|0.3|1.35||||||33.5°C for 120 hours vs. 33.5°C for 72 hours (33.5°C for 72 hours is the comparison group)||1.35|0.30|
72467939|NCT01192776|144458666|SUPERIORITY|Generalized Estimating Equations models with log link, adjusted for level of encephalopathy and intra-center correlations|Risk Ratio (RR)|0.47|||||TWO_SIDED|95.0|0.13|1.64||||||32.0°C for 120 hours vs. 33.5°C for 72 hours (33.5°C for 72 hours is the comparison group)||1.64|0.13|
72467940|NCT04974723|144458669|NON_INFERIORITY|Cox proportional hazard model was used to calculate the hazard ratio with teriparatide as reference. Noninferiority of abaloparatide to teriparatide was to be concluded if the upper bound of the 2-sided 95% CI of the HR between abaloparatide versus teriparatide was \<1.3.|Hazard Ratio (HR)|0.94|||||TWO_SIDED|95.0|0.81|1.1||||||||1.10|0.81|
72564853|NCT03314662|144661182|NON_INFERIORITY|aQIV was considered non-inferior to aTIV-1 or aTIV-2 if the upper bound of the two-sided 95% confidence interval (CI) for the ratios of GMTs (aTIV/aQIV) do not exceed 1.5.|GMT ratio: (aTIV/aQIV)]|0.98|||||TWO_SIDED|95.0|0.89|1.08|||||GMT ratios (adjusted) obtained from a GLM fitted on log-transformed (base 10) post-vaccination HI titer as outcome variable and covariate terms: treatment, pre-vaccination HI titer (log10 transformed), age, sex, vaccination history, study site|Comparison Group Selection: aQIV/aTIV - performed for strain B/Victoria||1.08|0.89|
72467941|NCT04974723|144458670|SUPERIORITY||Hazard Ratio (HR)|1.08|||||TWO_SIDED|95.0|0.89|1.3||||||Cox proportional hazard model was used to calculate the hazard ratio with teriparatide as reference. Noninferiority of abaloparatide to teriparatide was to be concluded if the upper bound of the 2-sided 95% CI of the HR between abaloparatide versus teriparatide was \<1.3.||1.30|0.89|
72467942|NCT04974723|144458671|SUPERIORITY||Hazard Ratio (HR)|1.08|||||TWO_SIDED|95.0|0.95|1.22||||||Cox proportional hazard model was used to calculate the hazard ratio with teriparatide as reference. Noninferiority of abaloparatide to teriparatide was to be concluded if the upper bound of the 2-sided 95% CI of the HR between abaloparatide versus teriparatide was \<1.3.||1.22|0.95|
72467943|NCT02250534|144458679|SUPERIORITY||Mean Difference (Net)|-5.33|STANDARD_ERROR_OF_MEAN|1.06|<|0.0001|TWO_SIDED|95.0|-7.41|-3.26||The p-value is Bonferroni-corrected for multiple comparisons with a priori threshold of significance P \< 0.0167|ANCOVA||Group difference = 0.12 mg nicotine - 0.8 mg nicotine|The statistical analysis method was ANCOVA, in order to test for statistically significant differences between group means, while controlling for covariates of interest. It was calculated that 207 subjects per group would be required to have at least 90% power to detect a mean difference of 4.52 CPD between the 0.8 mg and 0.12 mg groups at week 12, with significance level alpha of 0.0167. The significance level reflects the Bonferroni correction needed for testing of all pairwise comparisons.||-3.26|-7.41|<0.0001
72467944|NCT02250534|144458679|SUPERIORITY||Mean Difference (Net)|-7.54|STANDARD_ERROR_OF_MEAN|1.0|<|0.0001|TWO_SIDED|95.0|-9.51|-5.57||The p-value is Bonferroni-corrected for multiple comparisons with a priori threshold of significance P \< 0.0167|ANCOVA||Group difference = 0.03 mg nicotine - 0.8 mg nicotine|The statistical analysis method was ANCOVA, in order to test for statistically significant differences between group means, while controlling for covariates of interest. It was calculated that 207 subjects per group would be required to have at least 90% power to detect a mean difference of 6.07 CPD between the 0.8 mg and 0.03 mg groups at week 12, with significance level alpha of 0.0167. The significance level reflects the Bonferroni correction needed for testing of all pairwise comparisons.||-5.57|-9.51|<0.0001
72467945|NCT00832000|144458686|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.68|STANDARD_DEVIATION|1.24|<|0.001|TWO_SIDED|95.0|-2.66|-0.706|||Wald||Residual standard deviation.|P value indicates significance level of the Wald test associated with mexiletine effect from the linear mixed effects model (n=57). When a carryover effect was detected, the significance level associated with the additive portion of the mexiletine effect (labeled period 1) is followed by the level associated with the interaction of mexiletine and period 2 (labeled period 2). All P values were 2-sided and .05 was considered the threshold of statistical significance.||-0.706|-2.66|<0.001
72564854|NCT03314662|144661183|NON_INFERIORITY|aQIV was considered non-inferior to aTIV-1 or aTIV-2 if the upper bound of the two-sided 95% CI for the differences between the SCRs (aTIV - aQIV) do not exceed 10% for each of the four strains|SCR difference (aTIV minus aQIV)|3.23|||||TWO_SIDED|95.0|-1.3|7.76||||||Comparison Group Selection: aTIV minus aQIV - for strain A/H1N1||7.76|-1.30|
72621879|NCT02579759|144774074|SUPERIORITY||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.46||0.377|TWO_SIDED|97.5|-1.43|0.62|||ANCOVA|||"The main analysis was performed as follows:~1. Analysis population: modified Full Analysis Set (mFAS)~2. Statistical model: ANCOVA where the mean at 12 and 15 months of each treatment group was compared against the placebo group, adjusting for the baseline value and assuming centre as a random effect~3. Missing value imputation: multiple imputation taking into account the reason of missingness"||0.62|-1.43|0.377
72621880|NCT02579759|144774074|SUPERIORITY||Mean Difference (Final Values)|-0.36|STANDARD_ERROR_OF_MEAN|0.38||0.334|TWO_SIDED|97.5|-1.21|0.48|||ANCOVA|||"The main analysis was performed as follows:~1. Analysis population: modified Full Analysis Set (mFAS)~2. Statistical model: ANCOVA where the mean at 12 and 15 months of each treatment group was compared against the placebo group, adjusting for the baseline value and assuming centre as a random effect~3. Missing value imputation: multiple imputation taking into account the reason of missingness"||0.48|-1.21|0.334
72467946|NCT00832000|144458686|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.68|STANDARD_DEVIATION|1.24||0.04||95.0|-3.85|-0.139|||Wald||Residual standard deviation.|P value indicates significance level of the Wald test associated with mexiletine effect from the linear mixed effects model (n=57). When a carryover effect was detected, the significance level associated with the additive portion of the mexiletine effect (labeled period 1) is followed by the level associated with the interaction of mexiletine and period 2 (labeled period 2). All P values were 2-sided and .05 was considered the threshold of statistical significance.||-0.139|-3.85|0.04
72467947|NCT00832000|144458687|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.63|STANDARD_DEVIATION|1.19|<|0.001|TWO_SIDED|95.0|-2.0|-1.26|||Wald||Residual standard deviation.|P value indicates significance level of the Wald test associated with mexiletine effect from the linear mixed effects model. When a carryover effect was detected, the significance level associated with the additive portion of the mexiletine effect (labeled period 1) is followed by the level associated with the interaction of mexiletine and period 2 (labeled period 2). All P values were 2-sided and .05 was considered the threshold of statistical significance.||-1.26|-2.00|<0.001
72564855|NCT03314662|144661183|NON_INFERIORITY|aQIV was considered non-inferior to aTIV-1 or aTIV-2 if the upper bound of the two-sided 95% CI for the differences between the SCRs (aTIV - aQIV) do not exceed 10% for each of the four strains|SCR difference (aTIV minus aQIV)|0.37|||||TWO_SIDED|95.0|-4.23|4.96||||||Comparison Group Selection: aTIV minus aQIV - for strain A/H3N2||4.96|-4.23|
72467948|NCT00832000|144458688|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.26|STANDARD_DEVIATION|1.27|<|0.001|TWO_SIDED|95.0|-1.67|-0.861|||Wald||Residual standard deviation.|P value indicates significance level of the Wald test associated with mexiletine effect from the linear mixed effects model. When a carryover effect was detected, the significance level associated with the additive portion of the mexiletine effect (labeled period 1) is followed by the level associated with the interaction of mexiletine and period 2 (labeled period 2). All P values were 2-sided and .05 was considered the threshold of statistical significance.||-0.861|-1.67|<0.001
72467949|NCT00832000|144458689|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.918|STANDARD_DEVIATION|1.29|<|0.001|TWO_SIDED|95.0|-1.3|-0.532|||Wald||Residual standard deviation.|P value indicates significance level of the Wald test associated with mexiletine effect from the linear mixed effects model. When a carryover effect was detected, the significance level associated with the additive portion of the mexiletine effect (labeled period 1) is followed by the level associated with the interaction of mexiletine and period 2 (labeled period 2). All P values were 2-sided and .05 was considered the threshold of statistical significance.||-0.532|-1.30|<0.001
72467950|NCT00832000|144458690|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.109|STANDARD_DEVIATION|0.563|<|0.001|TWO_SIDED|95.0|-0.177|-0.056|||Wald||Residual standard deviation.|P value indicates significance level of the Wald test associated with mexiletine effect from the linear mixed effects model. All P values were 2-sided and .05 was considered the threshold of statistical significance.||-0.056|-0.177|<0.001
72467951|NCT00832000|144458691|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.54|STANDARD_DEVIATION|13.1||0.09|TWO_SIDED|95.0|-0.68|9.75|||wald||Residual standard deviation.|P value indicates significance level of the Wald test associated with mexiletine effect from the linear mixed effects model. All P values were 2-sided and .05 was considered the threshold of statistical significance.||9.75|-0.680|0.09
72467952|NCT00832000|144458692|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.568|STANDARD_DEVIATION|0.6|<|0.001|TWO_SIDED|95.0|-0.812|-0.325|||Wilcoxon (Mann-Whitney)||Residual standard deviation.|P value indicates significance level of the Wilcoxon test associated with mexiletine effect from the linear mixed effects model. The Wilcoxon test was substituted because the outcome is not continuous and therefore normality of the residuals is not satisfied. All P values were 2-sided and .05 was considered the threshold of statistical significance.||-0.325|-0.812|<0.001
72467953|NCT00832000|144458693|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.33|STANDARD_DEVIATION|1.083|<|0.001|TWO_SIDED|95.0|-0.633|-0.142|||Wald||Residual standard deviation.|P value indicates significance level of the Wald test associated with mexiletine effect from the linear mixed effects model. All P values were 2-sided and .05 was considered the threshold of statistical significance.||-0.142|-0.633|<0.001
72467954|NCT00832000|144458694|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.313|STANDARD_DEVIATION|0.889|<|0.001|TWO_SIDED|95.0|-0.602|-0.149|||Wald||Residual standard deviation.|P value indicates significance level of the Wald test associated with mexiletine effect from the linear mixed effects model. All P values were 2-sided and .05 was considered the threshold of statistical significance.||-0.149|-0.602|<0.001
72467955|NCT00832000|144458695|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.464|STANDARD_DEVIATION|0.516|<|0.001|TWO_SIDED|95.0|-0.675|-0.254|||Wilcoxon (Mann-Whitney)||Residual standard deviation.|P value indicates significance level of the Wilcoxon test associated with mexiletine effect from the linear mixed effects model. The Wilcoxon test was substituted because the outcome is not continuous and therefore normality of the residuals is not satisfied. All P values were 2-sided and .05 was considered the threshold of statistical significance.||-0.254|-0.675|<0.001
72467956|NCT00832000|144458696|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.69|STANDARD_DEVIATION|12.6||0.5|TWO_SIDED|95.0|-3.34|6.73|||wald||Residual standard deviation.|P value indicates significance level of the Wald test associated with mexiletine effect from the linear mixed effects model. All P values were 2-sided and .05 was considered the threshold of statistical significance.||6.73|-3.34|0.50
72467957|NCT00832000|144458697|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.69|STANDARD_DEVIATION|3.44|<|0.001|TWO_SIDED|95.0|-4.07|-1.3|||wald||Residual standard deviation.|P value indicates significance level of the Wald test associated with mexiletine effect from the linear mixed effects model. All P values were 2-sided and .05 was considered the threshold of statistical significance.||-1.30|-4.07|<0.001
72467958|NCT00832000|144458698|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.58|STANDARD_DEVIATION|5.35|<|0.001|TWO_SIDED|95.0|3.44|7.72|||wald||Residual standard deviation.|P value indicates significance level of the Wald test associated with mexiletine effect from the linear mixed effects model. All P values were 2-sided and .05 was considered the threshold of statistical significance.||7.72|3.44|<0.001
72504054|NCT01025336|144539188|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.2|||||TWO_SIDED|95.0|0.13|0.22|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 5: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.22|0.13|
72504055|NCT01025336|144539188|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.3|||||TWO_SIDED|95.0|0.22|0.33|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 5: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.33|0.22|
72504056|NCT01025336|144539188|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.3|||||TWO_SIDED|95.0|0.25|0.38|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 5: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.38|0.25|
72504057|NCT01025336|144539188|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.1|||||TWO_SIDED|95.0|0.08|0.14|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 6A: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.14|0.08|
72467959|NCT00832000|144458699|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.351|STANDARD_DEVIATION|6.5||0.9|TWO_SIDED|95.0|-5.87|5.17|||Wald||Residual standard deviation.|P value indicates significance level of the Wald test associated with mexiletine effect from the linear mixed effects model. When a carryover effect was detected, the significance level associated with the additive portion of the mexiletine effect (labeled period 1) is followed by the level associated with the interaction of mexiletine and period 2 (labeled period 2). All P values were 2-sided and .05 was considered the threshold of statistical significance.||5.17|-5.87|0.90
72564856|NCT03314662|144661183|NON_INFERIORITY|aQIV was considered non-inferior to aTIV-1 or aTIV-2 if the upper bound of the two-sided 95% CI for the differences between the SCRs (aTIV - aQIV) do not exceed 10% for each of the four strains|SCR difference (aTIV minus aQIV)]|-0.93|||||TWO_SIDED|95.0|-5.13|3.27||||||Comparison Group Selection: aTIV minus aQIV - for strain B-Yamagata||3.27|-5.13|
72467960|NCT00832000|144458699|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.4|STANDARD_ERROR_OF_MEAN|6.5||0.03|TWO_SIDED|95.0|0.941|20.6|||wald||Residual standard deviation.|P value indicates significance level of the Wald test associated with mexiletine effect from the linear mixed effects model. When a carryover effect was detected, the significance level associated with the additive portion of the mexiletine effect (labeled period 1) is followed by the level associated with the interaction of mexiletine and period 2 (labeled period 2). All P values were 2-sided and .05 was considered the threshold of statistical significance.||20.6|0.941|0.03
72467961|NCT00817336|144458710|SUPERIORITY_OR_OTHER||Cohen's d|0.8||||0.02|TWO_SIDED||||||Mixed Models Analysis|||||||0.02
72467962|NCT00817336|144458711|SUPERIORITY||Cohen's d|2.3||||0.001|TWO_SIDED||||||Mixed Models Analysis|||||||0.001
72467963|NCT00817336|144458712|SUPERIORITY_OR_OTHER||Cohen's d|0.41||||0.31|TWO_SIDED||||||Mixed Models Analysis|||||||.31
72467964|NCT00817336|144458713|SUPERIORITY||Cohen's d|0.41||||0.41|TWO_SIDED||||||Mixed Models Analysis|||||||.41
72467965|NCT01182181|144458732|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|95.6|||||TWO_SIDED|90.0|92.34|98.95|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||98.95|92.34|
72467966|NCT01182181|144458733|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|96.3|||||TWO_SIDED|90.0|93.14|99.57|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||99.57|93.14|
72467967|NCT01121913|144458734|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence is established when the ratio of geometric Least Squares means (LS means) and confidence interval calculated from the exponential of the difference between the Test and Reference product for the ln-transformed parameter AUC(0-t) is between 80% and 125%.|Mean ratio|102.0|||||TWO_SIDED|90.0|91.8|114.0|||||Trazodone Contramid® OAD (prototype 1)/Triticco®|||114|91.8|
72467968|NCT01121913|144458734|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence is established when the ratio of geometric Least Squares means (LS means) and confidence interval calculated from the exponential of the difference between the Test and Reference product for the ln-transformed parameter AUC(0-t) is between 80% and 125%.|Mean ratio|105.0|||||TWO_SIDED|90.0|93.9|117.0|||||Trazodone Contramid® OAD (prototype 1)/Desyrel®|||117|93.9|
72564857|NCT03314662|144661183|NON_INFERIORITY|aQIV was considered non-inferior to aTIV-1 or aTIV-2 if the upper bound of the two-sided 95% CI for the differences between the SCRs (aTIV - aQIV) do not exceed 10% for each of the four strains|Other [SCR difference (aTIV minus aQIV)]|-1.26|||||TWO_SIDED|95.0|-5.07|2.55||||||Comparison Group Selection: aTIV minus aQIV - for strain B-Victoria||2.55|-5.07|
72621881|NCT02579759|144774074|SUPERIORITY||Slope|-0.19|STANDARD_ERROR_OF_MEAN|0.22||0.373|TWO_SIDED|95.0|-0.62|0.23|||Regression, Linear|||"Dose is defined as a numerical variable proportional to quantity of PXT3003 administered (0 for Placebo, 1 for Dose 1, 2 for Dose 2).~The analysis was performed as follows:~1. Analysis population: modified Full Analysis Set (mFAS)~2. Statistical model: ANCOVA assessing the dose-effect at the mean of 12 and 15 months, adjusting for baseline value and assuming centre as random effect~3. Missing value imputation: multiple imputation taking into account the reason of missingness"||0.23|-0.62|0.373
72467969|NCT01121913|144458734|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence is established when the ratio of geometric Least Squares means (LS means) and confidence interval calculated from the exponential of the difference between the Test and Reference product for the ln-transformed parameter AUC(0-t) is between 80% and 125%.|Mean ratio|95.3|||||TWO_SIDED|90.0|85.5|106.0|||||Trazodone Contramid® OAD (prototype 2)/Triticco®|||106|85.5|
72467970|NCT01121913|144458734|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence is established when the ratio of geometric Least Squares means (LS means) and confidence interval calculated from the exponential of the difference between the Test and Reference product for the ln-transformed parameter AUC(0-t) is between 80% and 125%.|Mean ratio|97.7|||||TWO_SIDED|90.0|87.7|109.0|||||Trazodone Contramid® OAD (prototype 2)/Desyrel®|||109|87.7|
72467971|NCT01121913|144458735|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence is established when the ratio of geometric Least Squares means (LSmeans) and confidence interval calculated from the exponential of the difference between the Test and Reference product for the ln-transformed parameter AUC(0-∞) is between 80% and 125%.|Mean ratio|102.0|||||TWO_SIDED|90.0|91.8|114.0|||||Trazodone Contramid® OAD (prototype 1)/Triticco®|||114|91.8|
72467972|NCT01121913|144458735|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence is established when the ratio of geometric Least Squares means (LSmeans) and confidence interval calculated from the exponential of the difference between the Test and Reference product for the ln-transformed parameter AUC(0-∞) is between 80% and 125%.|Mean ratio|106.0|||||TWO_SIDED|90.0|95.1|118.0|||||Trazodone Contramid® OAD (prototype 1)/Desyrel®|||118|95.1|
72467973|NCT01121913|144458735|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence is established when the ratio of geometric Least Squares means (LSmeans) and confidence interval calculated from the exponential of the difference between the Test and Reference product for the ln-transformed parameter AUC(0-∞) is between 80% and 125%.|Mean ratio|94.9|||||TWO_SIDED|90.0|85.1|106.0|||||Trazodone Contramid® OAD (prototype 2)/Triticco®|||106|85.1|
72467974|NCT01121913|144458735|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence is established when the ratio of geometric Least Squares means (LSmeans) and confidence interval calculated from the exponential of the difference between the Test and Reference product for the ln-transformed parameter AUC(0-∞) is between 80% and 125%.|Mean ratio|98.4|||||TWO_SIDED|90.0|88.3|110.0|||||Trazodone Contramid® OAD (prototype 2)/Desyrel®|||110|88.3|
72467975|NCT01121913|144458736|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence is established when the ratio of geometric Least Squares means (LSmeans) and confidence interval calculated from the exponential of the difference between the Test and Reference product for the ln-transformed parameter Cmax is between 75% and 133%.|Mean ratio|73.3|||||TWO_SIDED|90.0|63.2|85.0|||||Trazodone Contramid® OAD (prototype 1)/Triticco®|||85|63.2|
72504058|NCT01025336|144539188|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.1|||||TWO_SIDED|95.0|0.06|0.1|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 6A: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.10|0.06|
72467976|NCT01121913|144458736|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence is established when the ratio of geometric Least Squares means (LSmeans) and confidence interval calculated from the exponential of the difference between the Test and Reference product for the ln-transformed parameter Cmax is between 75% and 133%.|Mean ratio|59.8|||||TWO_SIDED|90.0|51.5|69.4|||||Trazodone Contramid® OAD (prototype 1)/Desyrel®|||69.4|51.5|
72467977|NCT01121913|144458736|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence is established when the ratio of geometric Least Squares means (LSmeans) and confidence interval calculated from the exponential of the difference between the Test and Reference product for the ln-transformed parameter Cmax is between 75% and 133%.|Mean ratio|83.0|||||TWO_SIDED|90.0|71.5|96.4|||||Trazodone Contramid® OAD (prototype 2)/Triticco®|||96.4|71.5|
72467978|NCT01121913|144458736|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence is established when the ratio of geometric Least Squares means (LSmeans) and confidence interval calculated from the exponential of the difference between the Test and Reference product for the ln-transformed parameter Cmax is between 75% and 133%.|Mean ratio|67.7|||||TWO_SIDED|90.0|58.4|78.5|||||Trazodone Contramid® OAD (prototype 2)/Desyrel®|||78.5|58.4|
72467979|NCT03845075|144458763|SUPERIORITY||LS Mean Difference|3.6||||0.4671|TWO_SIDED|95.0|-6.58|13.78||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|Week 4; Safety set; LOCF||13.78|-6.58|0.4671
72467980|NCT03845075|144458763|SUPERIORITY||LS Mean Difference|10.11||||0.1808|TWO_SIDED|95.0|-5.14|25.36||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|Week 8; Safety set; LOCF||25.36|-5.14|0.1808
72564858|NCT03314662|144661186|SUPERIORITY|Superiority of aQIV vs. aTIV-1 for the alternate B strain was assessed using the GMT ratio (GMTaTIV/GMTaQIV); Superiority was declared if the upper limit of the two-sided 95% CI for the GMT ratio (aTIV/aQIV) was \<1. The superiority comparison was based on the Full Analysis Set (FAS) Immunogenicity comprised all subjects who were randomized, received at least 1 study vaccination, and provided immunogenicity data at Day 1 and Day 22.|GMT ratio|0.64|||||TWO_SIDED|95.0|0.58|0.7||||||B/Yamagata strain: GMT Ratio (aTIV/aQIV)||0.70|0.58|
72564859|NCT03314662|144661186|SUPERIORITY|Superiority of aQIV vs. aTIV-2 for the alternate B strain was assessed using the GMT ratio (GMTaTIV/GMTaQIV); Superiority was declared if the upper limit of the two-sided 95% CI for the GMT ratio (aTIV/aQIV) was \<1. The superiority comparison was based on the FAS Immunogenicity.|GMT ratio|0.71|||||TWO_SIDED|95.0|0.64|0.78||||||B/Victoria Strain: GMT Ratio (aTIV/aQIV)||0.78|0.64|
72621882|NCT02579759|144774078|SUPERIORITY||Mean Difference (Final Values)|-0.29|STANDARD_ERROR_OF_MEAN|0.13||0.023|TWO_SIDED|97.5|-0.58|0.0|||ANCOVA|||"The main analysis was performed as follows:~1. Analysis population: modified Full Analysis Set (mFAS)~2. Statistical model: ANCOVA where the mean at 12 and 15 months of each treatment group was compared against the placebo group, adjusting for the baseline value and assuming centre as a random effect~3. Missing value imputation: multiple imputation taking into account the reason of missingness"||0|-0.58|0.023
72467981|NCT03845075|144458763|SUPERIORITY||LS Mean Difference|4.63||||0.4171|TWO_SIDED|95.0|-7.08|16.33||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|Week 12; Safety set; LOCF||16.33|-7.08|0.4171
72467982|NCT03845075|144458763|SUPERIORITY||LS Mean Difference|5.33||||0.3116|TWO_SIDED|95.0|-5.43|16.1||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|Week 16; Safety set; LOCF||16.10|-5.43|0.3116
72504059|NCT01025336|144539188|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.3|||||TWO_SIDED|95.0|0.22|0.46|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 6A: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.46|0.22|
72504060|NCT01025336|144539188|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.5|||||TWO_SIDED|95.0|0.4|0.6|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 6B: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.60|0.40|
72394631|NCT02310568|144295797|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.92||0.708|TWO_SIDED|90.0|-1.9|1.2|||Mixed-Effects Model Repeated Measure|||(PF-06372865 2.5 mg - Placebo). Week 1: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||1.2|-1.9|0.708
72394632|NCT02310568|144295797|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|1.05||0.852|TWO_SIDED|90.0|-1.9|1.5|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 1: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||1.5|-1.9|0.852
72467983|NCT03845075|144458763|SUPERIORITY||LS Mean Difference|5.8||||0.2353|TWO_SIDED|95.0|-4.12|15.72||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|Week 20; Safety set; LOCF||15.72|-4.12|0.2353
72467984|NCT03845075|144458763|SUPERIORITY||LS Mean Difference|5.86||||0.3037|TWO_SIDED|95.0|-5.76|17.48||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|Week 24; Safety set; LOCF||17.48|-5.76|0.3037
72467985|NCT03845075|144458764|SUPERIORITY||LS Mean Difference|-1.31||||0.6543|TWO_SIDED|95.0|-7.33|4.72||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|Week 4; Safety set; LOCF||4.72|-7.33|0.6543
72467986|NCT03845075|144458764|SUPERIORITY||LS Mean Difference|0.94||||0.7941|TWO_SIDED|95.0|-6.5|8.38||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|Week 8; Safety set; LOCF||8.38|-6.50|0.7941
72467987|NCT03845075|144458764|SUPERIORITY||LS Mean Difference|-2.0||||0.5937|TWO_SIDED|95.0|-9.72|5.73||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|Week 12; Safety set; LOCF||5.73|-9.72|0.5937
72467988|NCT03845075|144458764|SUPERIORITY||LS Mean Difference|2.56||||0.5423|TWO_SIDED|95.0|-6.11|11.23||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|Week 16; Safety set; LOCF||11.23|-6.11|0.5423
72467989|NCT03845075|144458764|SUPERIORITY||LS Mean Difference|1.2||||0.7226|TWO_SIDED|95.0|-5.77|8.16||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|Week 20; Safety set; LOCF||8.16|-5.77|0.7226
72467990|NCT03845075|144458764|SUPERIORITY||LS Mean Difference|1.15||||0.7912|TWO_SIDED|95.0|-7.85|10.16||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|Week 24; Safety set; LOCF||10.16|-7.85|0.7912
72467991|NCT03845075|144458765|SUPERIORITY||LS Mean Difference|-1.35||||0.7023|TWO_SIDED|95.0|-8.67|5.97||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|Week 4; Safety set; LOCF||5.97|-8.67|0.7023
72504061|NCT01025336|144539188|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.4|||||TWO_SIDED|95.0|0.29|0.43|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 6B: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.43|0.29|
72504062|NCT01025336|144539188|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.4|||||TWO_SIDED|95.0|0.29|0.59|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 6B: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.59|0.29|
72394633|NCT02310568|144295797|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|1.14||0.347|TWO_SIDED|90.0|-3.0|0.8|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - Placebo). Week 2: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||0.8|-3.0|0.347
72467992|NCT03845075|144458765|SUPERIORITY||LS Mean Difference|-0.48||||0.9012|TWO_SIDED|95.0|-8.58|7.61||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|Week 8; Safety set; LOCF||7.61|-8.58|0.9012
72467993|NCT03845075|144458765|SUPERIORITY||LS Mean Difference|2.14||||0.6138|TWO_SIDED|95.0|-6.63|10.92||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|Week 12; Safety set; LOCF||10.92|-6.63|0.6138
72467994|NCT03845075|144458765|SUPERIORITY||LS Mean Difference|1.23||||0.7889|TWO_SIDED|95.0|-8.26|10.72||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|Week 16; Safety set; LOCF||10.72|-8.26|0.7889
72504063|NCT01025336|144539188|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.3|||||TWO_SIDED|95.0|0.17|0.38|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 7F: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.38|0.17|
72504064|NCT01025336|144539188|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.3|||||TWO_SIDED|95.0|0.21|0.36|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 7F: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.36|0.21|
72504065|NCT01025336|144539188|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.4|||||TWO_SIDED|95.0|0.27|0.56|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 7F: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.56|0.27|
72504066|NCT01025336|144539188|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.2|||||TWO_SIDED|95.0|0.13|0.28|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 9V: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.28|0.13|
72504067|NCT01025336|144539188|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.3|||||TWO_SIDED|95.0|0.2|0.39|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 9V: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.39|0.20|
72564860|NCT03314662|144661189|SUPERIORITY|Superiority of aQIV vs. aTIV-1 for the alternate B strain was assessed using the difference in SCR (SCRaTIV-SCRaQIV) at Day 22. Superiority was declared if the upper limit of the two-sided 95% CI for the difference in SCRs (aTIV-aQIV) was \<0, for both B strains. The superiority comparison was based on the FAS Immunogenicity.|SCR difference|-11.96|||||TWO_SIDED|95.0|-15.12|-8.81||||||B/Yamagata Strain: SCR Difference (aTIV-1 - aQIV).||-8.81|-15.12|
72564861|NCT03314662|144661189|SUPERIORITY|Superiority of aQIV vs. aTIV-2 for the alternate B strain was assessed using the difference in SCR (SCRaTIV-SCRaQIV) at Day 22. Superiority was declared if the upper limit of the two-sided 95% CI for the difference in SCRs (aTIV-aQIV) was \<0, for both B strains. The superiority comparison was based on the FAS Immunogenicity.|SCR difference|-10.82|||||TWO_SIDED|95.0|-13.54|-8.11||||||B/Victoria Strain: SCR Difference (aTIV-2 - aQIV)||-8.11|-13.54|
72564862|NCT00440115|144661198|SUPERIORITY|Power calculations demonstrated that 250 participants per group would have 95% power to compare combined high-intensity disease management and moderate-intensity disease management with pharmacotherapy management, on the basis of 10% (pharmacotherapy management), 15% (moderate-intensity disease management), and 25% (high-intensity disease management) self-reported quit rates.|Odds Ratio (OR)|1.12||||0.54|TWO_SIDED|95.0|0.78|1.61|||Mixed Models Analysis||(High-intensity disease management and moderate-intensity disease management) vs pharmacotherapy management|||1.61|0.78|0.54
72504068|NCT01025336|144539188|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.4|||||TWO_SIDED|95.0|0.28|0.67|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 9V: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.67|0.28|
72504069|NCT01025336|144539188|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.6|||||TWO_SIDED|95.0|0.48|0.83|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 14: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.83|0.48|
72504070|NCT01025336|144539188|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.6|||||TWO_SIDED|95.0|0.49|0.74|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 14: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.74|0.49|
72504071|NCT01025336|144539188|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.5|||||TWO_SIDED|95.0|0.42|0.65|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 14: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.65|0.42|
72504072|NCT01025336|144539188|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.3|||||TWO_SIDED|95.0|0.2|0.32|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 18C: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.32|0.20|
72504073|NCT01025336|144539188|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.3|||||TWO_SIDED|95.0|0.28|0.43|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 18C: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.43|0.28|
72467995|NCT03845075|144458765|SUPERIORITY||LS Mean Difference|0.3||||0.9536|TWO_SIDED|95.0|-10.34|10.94||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|Week 20; Safety set; LOCF||10.94|-10.34|0.9536
72467996|NCT03845075|144458765|SUPERIORITY||LS Mean Difference|2.7||||0.5551|TWO_SIDED|95.0|-6.72|12.12||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|Week 24; Safety set; LOCF||12.12|-6.72|0.5551
72467997|NCT03845075|144458769|SUPERIORITY||LS Mean Difference|-2.52||||0.7782|TWO_SIDED|95.0|-21.23|16.2||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate.|Baseline to Week 24||16.20|-21.23|0.7782
72467998|NCT03845075|144458769|SUPERIORITY||LS Mean Difference|-7.26||||0.313|TWO_SIDED|95.0|-22.09|7.56||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate.|Baseline to Week 48||7.56|-22.09|0.3130
72467999|NCT03845075|144458769|SUPERIORITY||LS Mean Difference|-5.73||||0.4033|TWO_SIDED|95.0|-19.92|8.47||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate.|Week 24 to Week 48||8.47|-19.92|0.4033
72468000|NCT03845075|144458770|SUPERIORITY||LS Mean Difference|-7.5||||0.0325|TWO_SIDED|95.0|-14.29|-0.71||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate.|Baseline to Week 24||-0.71|-14.29|0.0325
72468001|NCT03845075|144458770|SUPERIORITY||LS Mean Difference|-0.32||||0.9394|TWO_SIDED|95.0|-9.04|8.4||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate.|Baseline to Week 48||8.40|-9.04|0.9394
72468002|NCT03845075|144458770|SUPERIORITY||LS Mean Difference|6.91||||0.0135|TWO_SIDED|95.0|1.65|12.18||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate.|Week 24 to Week 28||12.18|1.65|0.0135
72468003|NCT03845075|144458771|SUPERIORITY||LS Mean Difference|-4.17||||0.1048|TWO_SIDED|95.0|-9.31|0.98||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate.|Baseline to Week 24; mITT observed.||0.98|-9.31|0.1048
72468004|NCT03845075|144458771|SUPERIORITY||LS Mean Difference|-0.99||||0.7189|TWO_SIDED|95.0|-6.75|4.77||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate.|Baseline to Week 48; mITT observed.||4.77|-6.75|0.7189
72468005|NCT03845075|144458771|SUPERIORITY||LS Mean Difference|3.09||||0.1053|TWO_SIDED|95.0|-0.73|6.91||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate.|Week 24 to Week 48; mITT observed.||6.91|-0.73|0.1053
72468006|NCT03845075|144458772|SUPERIORITY||LS Mean Difference|-3.12||||0.0033|TWO_SIDED|95.0|-5.02|-1.21||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate.|Baseline to Week 24; mITT observed||-1.21|-5.02|0.0033
72504074|NCT01025336|144539188|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.4|||||TWO_SIDED|95.0|0.29|0.45|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 18C: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.45|0.29|
72504075|NCT01025336|144539188|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.3|||||TWO_SIDED|95.0|0.3|0.41|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 19A: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.41|0.30|
72504076|NCT01025336|144539188|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.4|||||TWO_SIDED|95.0|0.35|0.45|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 19A: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.45|0.35|
72564863|NCT00440115|144661198|SUPERIORITY|Power calculations indicated that 250 participants per group would have 80% power to compare high-intensity disease management and moderate-intensity disease management with pharmacotherapy management, on the basis of 10% (pharmacotherapy management), 15% (moderate-intensity disease management), and 25% (high-intensity disease management) self-reported quit rates.|Odds Ratio (OR)|1.33||||0.18|TWO_SIDED|95.0|0.88|2.02|||Mixed Models Analysis||High-intensity disease management vs moderate-intensity disease management|||2.02|0.88|0.18
72564864|NCT02953678|144661244|OTHER||Exact method for binomial distributions|54.9|||||TWO_SIDED|95.0|42.7|66.8||||||||66.8|42.7|
72468007|NCT03845075|144458772|SUPERIORITY||LS Mean Difference|0.58||||0.6663|TWO_SIDED|95.0|-2.24|3.41||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate.|Baseline to Week 48; mITT LOCF||3.41|-2.24|0.6663
72468008|NCT03845075|144458772|SUPERIORITY||LS Mean Difference|3.59||||0.0058|TWO_SIDED|95.0|1.21|5.98||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate.|Week 24 to Week 48; mITT LOCF||5.98|1.21|0.0058
72504077|NCT01025336|144539188|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.4|||||TWO_SIDED|95.0|0.36|0.51|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 19A: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.51|0.36|
72504078|NCT01025336|144539188|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.5|||||TWO_SIDED|95.0|0.35|0.58|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 19F: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.58|0.35|
72504079|NCT01025336|144539188|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.5|||||TWO_SIDED|95.0|0.39|0.62|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 19F: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.62|0.39|
72504080|NCT01025336|144539188|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.4|||||TWO_SIDED|95.0|0.34|0.54|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 19F: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.54|0.34|
72504081|NCT01025336|144539188|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.3|||||TWO_SIDED|95.0|0.23|0.42|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 23F: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.42|0.23|
72504082|NCT01025336|144539188|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.2|||||TWO_SIDED|95.0|0.15|0.24|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 23F: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.24|0.15|
72504083|NCT01025336|144539188|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.5|||||TWO_SIDED|95.0|0.42|0.69|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 23F: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.69|0.42|
72504084|NCT01025336|144539189|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.4|||||TWO_SIDED|95.0|0.36|0.5|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 1: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.50|0.36|
72504085|NCT01025336|144539189|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.4|||||TWO_SIDED|95.0|0.36|0.48|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 1: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.48|0.36|
72504086|NCT01025336|144539189|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.4|||||TWO_SIDED|95.0|0.33|0.44|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 3: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.44|0.33|
72504087|NCT01025336|144539189|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.3|||||TWO_SIDED|95.0|0.26|0.37|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 3: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.37|0.26|
72504088|NCT01025336|144539189|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.5|||||TWO_SIDED|95.0|0.42|0.68|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 4: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.68|0.42|
72504089|NCT01025336|144539189|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.9|||||TWO_SIDED|95.0|0.64|1.14|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 4: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||1.14|0.64|
72564865|NCT00784134|144661258|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.027||||0.554|TWO_SIDED|95.0|-0.062|0.115|||Chi-squared|||||0.115|-0.062|0.554
72564866|NCT00784134|144661258|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.18||||0.465|TWO_SIDED|95.0|0.75|1.87||Multivariable logit model adjusted for age, GCS, thalamus, stability ICH volume and stability IVH volume.|Multivariable Logit Model|||||1.87|0.75|0.465
72564867|NCT00784134|144661259|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.89||||0.484|TWO_SIDED|95.0|0.63|1.25||Generalized ordered logit model adjusted for age, GCS, thalamus, stability ICH volume and stability IVH volume (categorical) compares odds ratio for mRS score \> K v. \<= K for K = 1 - 4; Alt v. Sal.|Generalized ordered Logit Model|||||1.25|0.63|0.484
72564868|NCT00784134|144661259|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.44|||<|0.001|TWO_SIDED|95.0|0.28|0.71||The same generalized ordered logit model, adjusting for age, GCS, thalamus, stability ICH volume and stability IVH volume (categorical), compares odds ratio for mRS score greater than 5 versus mRS score equal or less than 5 (dead versus alive).|Generalized ordered Logit Model|||||0.71|0.28|<0.001
72468009|NCT03845075|144458773|SUPERIORITY||LS Mean Difference|-3.02||||0.0713|TWO_SIDED|95.0|-6.34|0.3||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate.|Baseline to Week 24; mITT observed||0.30|-6.34|0.0713
72504090|NCT01025336|144539189|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.7|||||TWO_SIDED|95.0|0.6|0.82|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 5: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.82|0.60|
72504091|NCT01025336|144539189|SUPERIORITY_OR_OTHER||Geometric mean fold rise|1.0|||||TWO_SIDED|95.0|0.86|1.18|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 5: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||1.18|0.86|
72504092|NCT01025336|144539189|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.3|||||TWO_SIDED|95.0|0.22|0.33|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 6A: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.33|0.22|
72468010|NCT03845075|144458773|SUPERIORITY||LS Mean Difference|-2.48||||0.1457|TWO_SIDED|95.0|-5.92|0.96||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate.|Baseline to Week 48; mITT LOCF||0.96|-5.92|0.1457
72468011|NCT03845075|144458773|SUPERIORITY||LS Mean Difference|0.85||||0.1837|TWO_SIDED|95.0|-0.45|2.15||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate.|Week 24 to Week 48; mITT LOCF||2.15|-0.45|0.1837
72468012|NCT03845075|144458774|SUPERIORITY||LS Mean Difference|-0.05||||0.7926|TWO_SIDED|95.0|-0.42|0.33||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate.|Baseline to Week 24; mITT LOCF||0.33|-0.42|0.7926
72468013|NCT03845075|144458774|SUPERIORITY||LS Mean Difference|-0.27||||0.2124|TWO_SIDED|95.0|-0.72|0.17||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate.|Baseline to Week 48; mITT LOCF||0.17|-0.72|0.2124
72468014|NCT03845075|144458774|SUPERIORITY||LS Mean Difference|-0.14||||0.6084|TWO_SIDED|95.0|-0.72|0.43||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate.|Week 24 to Week 48; mITT LOCF||0.43|-0.72|0.6084
72468015|NCT03845075|144458775|SUPERIORITY||LS Mean Difference|16.0||||0.0905|TWO_SIDED|95.0|-2.85|34.85||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate.|Baseline to week 24; mITT observed. (Like to eat something fatty)||34.85|-2.85|0.0905
72564869|NCT00784134|144661260|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.026||||0.552|TWO_SIDED|95.0|-0.059|0.111|||Chi-squared|||||0.111|-0.059|0.552
72564870|NCT00784134|144661260|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.23||||0.35|TWO_SIDED|95.0|0.8|1.9||Multivariable logit model adjusting for age, GCS, thalamus, stability ICH volume and stability IVH volume (categorical).|Multivariable Logit Model|||||1.90|0.80|0.350
72564871|NCT00784134|144661261|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.18||||0.428|TWO_SIDED|95.0|0.78|1.8||Random effects model with site as random effect adjusted for age, GCS, thalamus, stability ICH volume and stability IVH volume (categorical).|Random Effects Model|||||1.80|0.78|0.428
72564872|NCT00784134|144661262|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.26||||0.384|TWO_SIDED|95.0|0.75|2.1|||Generalized Estimating Equation Model|Generalized estimating equation model adjusting for age, GCS, thalamus, stability ICH volume and stability IVH volume (categorical).||Logit mRS scores 0-3 at 30 days||2.10|0.75|0.384
72564873|NCT00784134|144661262|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.01||||0.964|TWO_SIDED|95.0|0.62|1.64|||Generalized Estimating Equation Model|Generalized estimating equation model adjusting for age, GCS, thalamus, stability ICH volume and stability IVH volume (categorical).||Logit mRS scores 0-3 at 180 days||1.64|0.62|0.964
72564874|NCT00784134|144661263|SUPERIORITY_OR_OTHER|||||||0.0056|||||||Log Rank|||||||0.0056
72564875|NCT00784134|144661264|SUPERIORITY_OR_OTHER||||||<|0.001|||||||AUC/ Logit Model|||||||<0.001
72621883|NCT02579759|144774078|SUPERIORITY||Mean Difference (Final Values)|-0.15|STANDARD_ERROR_OF_MEAN|0.11||0.162|TWO_SIDED|97.5|-0.4|0.09|||ANCOVA|||"The main analysis was performed as follows:~1. Analysis population: modified Full Analysis Set (mFAS)~2. Statistical model: ANCOVA where the mean at 12 and 15 months of each treatment group was compared against the placebo group, adjusting for the baseline value and assuming centre as a random effect~3. Missing value imputation: multiple imputation taking into account the reason of missingness"||0.09|-0.4|0.162
72621884|NCT02579759|144774082|SUPERIORITY||Odds Ratio (OR)|2.09||||0.097|TWO_SIDED|97.5|0.77|5.68|||General Linear Mixed Model|||The proportion of responders (on Completers selection only) at the end of treatment was assessed through a Generalized Linear Mixed Model (GLMM) featuring logistic regression including treatment as a fixed effect, adjusting for the baseline value and center as a random effect.||5.68|0.77|0.097
72621885|NCT02579759|144774082|SUPERIORITY||Odds Ratio (OR)|1.07||||0.865|TWO_SIDED|97.5|0.42|2.7|||General Linear Mixed Model|||The proportion of responders (on Completers selection only) at the end of treatment was assessed through a Generalized Linear Mixed Model (GLMM) featuring logistic regression including treatment as a fixed effect, adjusting for the baseline value and center as a random effect.||2.7|0.42|0.865
72504093|NCT01025336|144539189|SUPERIORITY_OR_OTHER||Geometric mean fold rise|1.1|||||TWO_SIDED|95.0|0.81|1.46|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 6A: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||1.46|0.81|
72564876|NCT00784134|144661265|SUPERIORITY_OR_OTHER|||||||0.771|||||||Kruskal-Wallis|||||||0.771
72564877|NCT00784134|144661266|SUPERIORITY_OR_OTHER|||||||0.098|||||||Kruskal-Wallis|||||||0.098
72564878|NCT00784134|144661267|SUPERIORITY_OR_OTHER|||||||0.45|||||||Generalized Linear Models|||||||0.450
72564879|NCT00784134|144661268|SUPERIORITY_OR_OTHER|||||||0.501|||||||Chi-squared|||||||0.501
72621886|NCT02579759|144774083|SUPERIORITY||Odds Ratio (OR)|3.39||||0.026|TWO_SIDED|97.5|0.99|11.62|||General Linear Mixed Model|||The proportion of responders (on Completers selection only) at the end of treatment was assessed through a Generalized Linear Mixed Model (GLMM) featuring logistic regression including treatment as a fixed effect, adjusting for the baseline value and center as a random effect.||11.62|0.99|0.026
72621887|NCT02579759|144774083|SUPERIORITY||Odds Ratio (OR)|1.26||||0.569|TWO_SIDED|97.5|0.5|3.16|||General Linear Mixed Model|||The proportion of responders (on Completers selection only) at the end of treatment was assessed through a Generalized Linear Mixed Model (GLMM) featuring logistic regression including treatment as a fixed effect, adjusting for the baseline value and center as a random effect.||3.16|0.5|0.569
72564880|NCT00784134|144661269|SUPERIORITY_OR_OTHER|||||||0.795|||||||Chi-squared|||||||0.795
72564881|NCT00784134|144661270|SUPERIORITY_OR_OTHER|||||||0.784|||||||Chi-squared|||||||0.784
72621888|NCT01879826|144774127|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|With a power of 0.8 and an acceptable type I error size of 0.05, 38 patients per group was estimated to achieve significance||||||0.044|||||||t-test, 2 sided|||||||0.044
72621889|NCT01879826|144774128|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|With a power of 0.8 and an acceptable type I error size of 0.05, 38 patients per group was estimated to achieve significance.||||||0.04|||||||t-test, 2 sided|||||||0.04
72621890|NCT02003898|144774135|NON_INFERIORITY|non-inferiority test with an A1C margin of 0.4% and a significance level of 0.025 (one-sided).|Mean Difference (Net)|0.034|||||TWO_SIDED|95.0|-0.03|0.098||||||||0.098|-0.03|
72621891|NCT01946880|144774195|OTHER|The estimated risk difference (i.e. risk(MMF Withdrawal) - risk(MMF Maintenance)) and 95% confidence intervals around the risk difference at Week 60 were reported using the Kaplan-Meier product-limit estimator.|Risk Difference (RD)|0.07|||||TWO_SIDED|95.0|-0.068|0.214||||||||0.214|-0.068|
72621892|NCT01946880|144774197|OTHER||Risk Difference (RD)|0.08|||||TWO_SIDED|95.0|-0.116|0.279||||||||0.279|-0.116|
72621893|NCT01946880|144774198|OTHER|The estimated risk difference (i.e. risk(MMF Withdrawal) - risk(MMF Maintenance)) and 95% confidence intervals around the risk difference at Week 60 were reported using the Kaplan-Meier product-limit estimator.|Risk Difference (RD)|0.13|||||TWO_SIDED|95.0|-0.091|0.36||||||||0.360|-0.091|
72504094|NCT01025336|144539189|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.4|||||TWO_SIDED|95.0|0.34|0.51|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 6B: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.51|0.34|
72564882|NCT00784134|144661271|SUPERIORITY_OR_OTHER|||||||0.592|||||||Chi-squared|||||||0.592
72564883|NCT00784134|144661272|SUPERIORITY_OR_OTHER|||||||0.105|||||||Chi-squared|||||||0.105
72564884|NCT00784134|144661273|SUPERIORITY_OR_OTHER|||||||0.152|||||||Chi-squared|||||||0.152
72564885|NCT00784134|144661274|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.055||||0.055|TWO_SIDED|95.0|-0.111|0.008|||Fisher Exact|||||0.008|-0.111|0.055
72564886|NCT00784134|144661275|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.035||||0.202|TWO_SIDED|95.0|-0.084|0.014|||Fisher Exact|||||0.014|-0.084|0.202
72564887|NCT00784134|144661276|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.004||||0.771|TWO_SIDED|95.0|-0.022|0.03|||Fisher Exact|||||0.030|-0.022|0.771
72564888|NCT00784134|144661277|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.004||||0.811|TWO_SIDED|95.0|-0.028|0.036|||Fisher Exact|||||0.036|-0.028|0.811
72564889|NCT00784134|144661278|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.144||||0.0017|TWO_SIDED|95.0|-0.23|-0.057|||Fisher Exact|||||-0.057|-0.230|0.0017
72564890|NCT00784134|144661279|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.6||||0.006|TWO_SIDED|95.0|0.41|0.86|||Cox Proportional Hazards Model|Adjusted Cox Proportional Hazards Model adjusting for age, GCS, thalamus, stability ICH volume and stability IVH volume (categorical).||||0.86|0.41|0.006
72621894|NCT01946880|144774199|OTHER|The estimated risk difference (i.e. risk(MMF Withdrawal) - risk(MMF Maintenance)) and 95% confidence intervals around the risk difference at Week 60 were reported using the Kaplan-Meier product-limit estimator.|Risk Difference (RD)|-0.07|||||TWO_SIDED|95.0|-0.475|0.333||||||||0.333|-0.475|
72621895|NCT01946880|144774200|OTHER||Risk Difference (RD)|-0.02|||||TWO_SIDED|95.0|-0.286|0.249||||||The estimated risk difference (i.e. risk(MMF Withdrawal) - risk(MMF Maintenance)) and 95% confidence intervals around the risk difference at Week 60 were reported using the Kaplan-Meier product-limit estimator.||0.249|-0.286|
72468016|NCT03845075|144458775|SUPERIORITY||LS Mean Difference|6.65||||0.6285|TWO_SIDED|95.0|-22.05|35.36||P-value from ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate.|Baseline to Week 24; mITT observed. (Like some meat/fish)||35.36|-22.05|0.6285
72468017|NCT03845075|144458775|SUPERIORITY||LS Mean Difference|-6.81||||0.5884|TWO_SIDED|95.0|-33.05|19.43||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate.|Baseline to Week 24; mITT observed. (Eat something salty).||19.43|-33.05|0.5884
72468018|NCT03845075|144458775|SUPERIORITY||LS Mean Difference|2.98||||0.8533|TWO_SIDED|95.0|-30.73|36.68||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate.|Baseline to Week 24; mITT observed. (Eat something sweet).||36.68|-30.73|0.8533
72564891|NCT00784134|144661280|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.064||||0.41|TWO_SIDED|95.0|-0.088|0.217|||Chi-squared|||||0.217|-0.088|0.410
72468019|NCT03845075|144458775|SUPERIORITY||LS Mean Difference|-17.33||||0.1529|TWO_SIDED|95.0|-41.87|7.2||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|Baseline to Week 48; mITT LOCF. (Like to eat something fatty).||7.20|-41.87|0.1529
72468020|NCT03845075|144458775|SUPERIORITY||LS Mean Difference|-11.75||||0.3399|TWO_SIDED|95.0|-37.15|13.65||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|Baseline to Week 48; mITT LOCF. (Like some meat/fish).||13.65|-37.15|0.3399
72468021|NCT03845075|144458775|SUPERIORITY||LS Mean Difference|-23.95||||0.0673|TWO_SIDED|95.0|-49.84|1.93||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|Baseline to Week 48; mITT LOCF. (Eat something salty).||1.93|-49.84|0.0673
72564892|NCT00784134|144661281|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.016||||0.781|TWO_SIDED|95.0|-0.096|0.128|||Chi-squared|||||0.128|-0.096|0.781
72564893|NCT00784134|144661282|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.02||||0.773|TWO_SIDED|95.0|-0.113|0.152|||Chi-squared|||||0.152|-0.113|0.773
72564894|NCT00784134|144661283|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.032||||0.587|TWO_SIDED|95.0|-0.085|0.151|||Chi-squared|||||0.151|-0.085|0.587
72564895|NCT00784134|144661284|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.015||||0.775|TWO_SIDED|95.0|-0.09|0.121|||Chi-squared|||||0.121|-0.09|0.775
72468022|NCT03845075|144458775|SUPERIORITY||LS Mean Difference|-22.6||||0.1657|TWO_SIDED|95.0|-55.65|10.46||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|Baseline to Week 48; mITT LOCF. (Eat something sweet).||10.46|-55.65|0.1657
72564896|NCT00784134|144661285|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.019||||0.808|TWO_SIDED|95.0|-0.132|0.169|||Chi-squared|||||0.169|-0.132|0.808
72564897|NCT00784134|144661286|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.033||||0.625|TWO_SIDED|95.0|-0.165|0.099|||Chi-squared|||||0.099|-0.165|0.625
72564898|NCT00784134|144661287|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.087||||0.191|TWO_SIDED|95.0|-0.043|0.218|||Chi-squared|||||0.218|-0.043|0.191
72564899|NCT00784134|144661288|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.0066||||0.949|TWO_SIDED|95.0|-0.197|0.211|||Chi-squared|||||0.211|-0.197|0.949
72564900|NCT00784134|144661289|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.014||||0.812|TWO_SIDED|95.0|-0.098|0.126|||Chi-squared|||||0.126|-0.098|0.812
72564901|NCT00784134|144661290|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.059||||0.394|TWO_SIDED|95.0|-0.076|0.194|||Chi-squared|||||0.194|-0.076|0.394
72564902|NCT00784134|144661291|SUPERIORITY_OR_OTHER|||||||0.312|||||||Wilcoxon (Mann-Whitney)|||||||0.312
72564903|NCT00784134|144661292|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.075||||0.087|TWO_SIDED|95.0|-0.011|0.16||Analysis of dichotomous eGOS, comparing Upper Severe Disability scores to Lower Severe Disability scores|Chi-squared|||||0.160|-0.011|0.087
72564904|NCT00784134|144661292|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.54||||0.064|TWO_SIDED|95.0|0.98|2.43||Adjusted Multivariable Logit Model comparing eGOS scores of Upper Severe Disability or greater versus Lower Severe Disability and worse; Alteplase versus Saline|Multivariable Logit Model|||||2.43|0.98|0.064
72564905|NCT00784134|144661292|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.42||||0.336|TWO_SIDED|95.0|0.7|2.89||Adjusted generalized ordered logit model odds ratios for eGOS scores of Moderate Disability or worse versus Good Recovery; Alteplase versus Saline|Generalized Ordered Logit Model|||||2.89|0.70|0.336
72564906|NCT00784134|144661292|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.93||||0.783|TWO_SIDED|95.0|0.57|1.52||Adjusted generalized ordered logit model odds ratios for eGOS scores of Upper Severe Disability or worse versus Moderate Disability + Good Recovery; Alteplase versus Saline|Generalized Ordered Logit Model|||||1.52|0.57|0.783
72564907|NCT00784134|144661293|SUPERIORITY_OR_OTHER|||||||0.14|||||||Wilcoxon (Mann-Whitney)|||||||0.14
72564908|NCT00784134|144661294|SUPERIORITY_OR_OTHER|||||||0.312|||||||t-test, 2 sided|||||||0.312
72564909|NCT00784134|144661295|SUPERIORITY_OR_OTHER|||||||0.65|||||||t-test, 2 sided|||||||0.65
72564910|NCT00784134|144661296|SUPERIORITY_OR_OTHER|||||||0.478|||||||t-test, 2 sided|||||||0.478
72564911|NCT00784134|144661297|SUPERIORITY_OR_OTHER|||||||0.634|||||||t-test, 2 sided|||||||0.634
72564912|NCT00784134|144661298|SUPERIORITY_OR_OTHER|||||||0.255|||||||t-test, 2 sided|||||||0.255
72564913|NCT00784134|144661299|SUPERIORITY_OR_OTHER|||||||0.224|||||||t-test, 2 sided|||||||0.224
72564914|NCT00784134|144661300|SUPERIORITY_OR_OTHER|||||||0.882|||||||t-test, 2 sided|||||||0.882
72394634|NCT02310568|144295797|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|1.14||0.759|TWO_SIDED|90.0|-2.2|1.5|||Mixed-Effects Model Repeated Measure|||(PF-06372865 2.5 mg - Placebo). Week 2: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||1.5|-2.2|0.759
72468023|NCT03845075|144458775|SUPERIORITY||LS Mean Difference|-30.18||||0.0108|TWO_SIDED|95.0|-52.31|-8.06||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|Week 24 to week 48; mITT LOCF. (Like to eat something fatty).||-8.06|-52.31|0.0108
72468024|NCT03845075|144458775|SUPERIORITY||LS Mean Difference|-14.79||||0.171|TWO_SIDED|95.0|-36.71|7.13||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|Week 24 to week 48; mITT LOCF. (Like some meat/fish).||7.13|-36.71|0.1710
72468025|NCT03845075|144458775|SUPERIORITY||LS Mean Difference|-19.86||||0.0083|TWO_SIDED|95.0|-33.8|-5.93||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|Week 24 to week 48; mITT LOCF. (Eat something salty).||-5.93|-33.80|0.0083
72468026|NCT03845075|144458775|SUPERIORITY||LS Mean Difference|-22.98||||0.0631|TWO_SIDED|95.0|-47.39|1.43||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|Week 24 to week 48; mITT LOCF. (Eat something sweet).||1.43|-47.39|0.0631
72504095|NCT01025336|144539189|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.9|||||TWO_SIDED|95.0|0.66|1.09|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 6B: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||1.09|0.66|
72504096|NCT01025336|144539189|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.5|||||TWO_SIDED|95.0|0.37|0.68|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 7F: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.68|0.37|
72564915|NCT00784134|144661301|SUPERIORITY_OR_OTHER|||||||0.551|||||||t-test, 2 sided|||||||0.551
72564916|NCT00784134|144661302|SUPERIORITY_OR_OTHER|||||||0.224|||||||t-test, 2 sided|||||||0.224
72564917|NCT00784134|144661303|SUPERIORITY_OR_OTHER|||||||0.376|||||||t-test, 2 sided|||||||0.376
72564918|NCT01546142|144661347|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|2.983|||<|0.001|TWO_SIDED|95.0|2.311|3.849|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) method stratified by pooled study center.|A risk ratio greater than 1 favors deoxycholic acid injection treatment, and between 0 and 1 favors placebo.|The primary analysis was satisfied if both null hypotheses (that there is no treatment difference in 1-grade or 2-grade response rate) were rejected in favor of the two-tailed alternative at the 0.05 level of significance for both primary efficacy endpoints, and the response rates were higher for the deoxycholic acid injection treatment group than the placebo group. Because both hypotheses must be rejected, the type I error was preserved when testing the primary endpoints.||3.849|2.311|<0.001
72564919|NCT01546142|144661348|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|6.271|||<|0.001|TWO_SIDED|95.0|2.908|13.52|||Cochran-Mantel-Haenszel|CMH method stratified by pooled study center.|A risk ratio greater than 1 favors deoxycholic acid injection treatment, and between 0 and 1 favors placebo.|The primary analysis was satisfied if both null hypotheses (that there is no treatment difference in 1-grade or 2-grade response rate) were rejected in favor of the two-tailed alternative at the 0.05 level of significance for both primary efficacy endpoints, and the response rates were higher for the deoxycholic acid injection treatment group than the placebo group. Because both hypotheses must be rejected, the type I error was preserved when testing the primary endpoints.||13.520|2.908|<0.001
72468027|NCT03845075|144458776|SUPERIORITY||LS Mean Difference|-2.56||||0.8082|TWO_SIDED|95.0|-24.65|19.53||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|Baseline to Week 24; mITT observed.||19.53|-24.65|0.8082
72468028|NCT03845075|144458776|SUPERIORITY||LS Mean Difference|-1.42||||0.9034|TWO_SIDED|95.0|-25.94|23.1||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|Baseline to Week 48; mITT LOCF.||23.10|-25.94|0.9034
72564920|NCT01546142|144661349|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|7.838|||<|0.001|TWO_SIDED|95.0|3.299|18.622|||Cochran-Mantel-Haenszel|CMH method stratified by pooled study center|A risk ratio greater than 1 favors deoxycholic acid injection treatment, and between 0 and 1 favors placebo.|If both primary endpoints were statistically significant, testing continued to the 2 secondary endpoints using the Bonferroni-Holm method. The smaller of the 2 p-values for the treatment difference was tested at the 0.025 level. If significant, testing proceeded for the remaining secondary endpoint at the 0.05 level. If the smaller p-value was \> 0.025, the null hypothesis for the associated variable would not be rejected, and testing of the second endpoint would not proceed.||18.622|3.299|<0.001
72468029|NCT03845075|144458776|SUPERIORITY||LS Mean Difference|-7.0||||0.4658|TWO_SIDED|95.0|-26.93|12.93||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|Week 24 to week 48; mITT LOCF.||12.93|-26.93|0.4658
72468030|NCT03845075|144458777|SUPERIORITY||LS Mean Difference|-5.68||||0.0537|TWO_SIDED|95.0|-11.46|0.1||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|Baseline to Week 24; mITT LOCF.||0.10|-11.46|0.0537
72468031|NCT03845075|144458777|SUPERIORITY||LS Mean Difference|-2.69||||0.3772|TWO_SIDED|95.0|-8.98|3.61||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|Baseline to Week 48; mITT LOCF.||3.61|-8.98|0.3772
72468032|NCT03845075|144458777|SUPERIORITY||LS Mean Difference|3.03||||0.1171|TWO_SIDED|95.0|-0.85|6.91||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|Week 24 to week 48; mITT LOCF.||6.91|-0.85|0.1171
72468033|NCT03845075|144458778|SUPERIORITY||LS Mean Difference|-0.05||||0.8623|TWO_SIDED|95.0|-0.59|0.5||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|Baseline to Week 24; mITT observed. (Change in total cholesterol)||0.50|-0.59|0.8623
72564921|NCT01546142|144661350|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|Analysis of covariance (ANCOVA) model included treatment and Baseline PR-SMFIS total scale score.||If both primary endpoints were statistically significant, testing continued to the 2 secondary endpoints using the Bonferroni-Holm method. The smaller of the 2 p-values for the treatment difference was tested at the 0.025 level. If significant, testing proceeded for the remaining secondary endpoint at the 0.05 level. If the smaller p-value was \> 0.025, the null hypothesis for the associated variable would not be rejected, and testing of the second endpoint would not proceed.||||<0.001
72468034|NCT03845075|144458778|SUPERIORITY||LS Mean Difference|0.03||||0.8327|TWO_SIDED|95.0|-0.25|0.3||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|Baseline to Week 24; mITT observed. (Change in HDL cholesterol)||0.30|-0.25|0.8327
72468035|NCT03845075|144458778|SUPERIORITY||LS Mean Difference|-0.06||||0.808|TWO_SIDED|95.0|-0.53|0.42||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|Baseline to Week 24; mITT observed. (Change in LDL cholesterol)||0.42|-0.53|0.8080
72468036|NCT03845075|144458778|SUPERIORITY||LS Mean Difference|0.22||||0.5791|TWO_SIDED|95.0|-0.62|1.07|||ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|Baseline to Week 24; mITT observed. (Change in triglycerides)||1.07|-0.62|0.5791
72468037|NCT03845075|144458778|SUPERIORITY||LS Mean Difference|0.03||||0.9337|TWO_SIDED|95.0|-0.71|0.77||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|Baseline to Week 48; mITT LOCF. (Change in cholesterol)||0.77|-0.71|0.9337
72468038|NCT03845075|144458778|SUPERIORITY||LS Mean Difference|0.01||||0.9305|TWO_SIDED|95.0|-0.21|0.23||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|Baseline to Week 48; mITT LOCF. (Change in HDL cholesterol)||0.23|-0.21|0.9305
72468039|NCT03845075|144458778|SUPERIORITY||LS Mean Difference|0.09||||0.691|TWO_SIDED|95.0|-0.4|0.59||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|Baseline to Week 48; mITT LOCF. (Change in LDL cholesterol)||0.59|-0.40|0.6910
72468040|NCT03845075|144458778|SUPERIORITY||LS Mean Difference|0.35||||0.2688|TWO_SIDED|95.0|-0.3|1.01||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|Baseline to Week 48; mITT LOCF. (Change in triglycerides)||1.01|-0.30|0.2688
72468041|NCT03845075|144458778|SUPERIORITY||LS Mean Difference|0.06||||0.8262|TWO_SIDED|95.0|-0.54|0.67||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|Week 24 to week 48; mITT LOCF. (Change in cholesterol)||0.67|-0.54|0.8262
72621896|NCT01946880|144774201|OTHER|The estimated risk difference (i.e. risk(MMF Withdrawal) - risk(MMF Maintenance)) and 95% confidence intervals around the risk difference at Week 60 were reported using the Kaplan-Meier product-limit estimator.|Risk Difference (RD)|0.2|||||TWO_SIDED|95.0|-0.09|0.497||||||||0.497|-0.090|
72468042|NCT03845075|144458778|SUPERIORITY||LS Mean Difference|-0.02||||0.8293|TWO_SIDED|95.0|-0.2|0.17||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|Week 24 to week 48; mITT LOCF. (Change in HDL cholesterol)||0.17|-0.20|0.8293
72468043|NCT03845075|144458778|SUPERIORITY||LS Mean Difference|0.11||||0.5486|TWO_SIDED|95.0|-0.27|0.49||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|Week 24 to week 48; mITT LOCF. (Change in LDL cholesterol)||0.49|-0.27|0.5486
72468044|NCT03845075|144458778|SUPERIORITY||LS Mean Difference|0.24||||0.3226|TWO_SIDED|95.0|-0.26|0.75||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|Week 24 to week 48; mITT LOCF. (Change in triglycerides)||0.75|-0.26|0.3226
72468045|NCT03845075|144458779|SUPERIORITY||LS Mean Difference|0.59||||0.842|TWO_SIDED|95.0|-5.55|6.73||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|From baseline to week 24; mITT LOCF. (Physical component score)||6.73|-5.55|0.8420
72468046|NCT03845075|144458779|SUPERIORITY||LS Mean Difference|-1.74||||0.6693|TWO_SIDED|95.0|-10.15|6.67||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|From baseline to week 24; mITT LOCF. (Mental component score)||6.67|-10.15|0.6693
72468047|NCT03845075|144458779|SUPERIORITY||LS Mean Difference|-1.83||||0.5444|TWO_SIDED|95.0|-8.12|4.46||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|From baseline to week 48; mITT LOCF. (Physical component score)||4.46|-8.12|0.5444
72468048|NCT03845075|144458779|SUPERIORITY||LS Mean Difference|-1.85||||0.5595|TWO_SIDED|95.0|-8.47|4.76||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|From baseline to week 48; mITT LOCF. (Mental component score)||4.76|-8.47|0.5595
72468049|NCT03845075|144458779|SUPERIORITY||LS Mean Difference|-2.07||||0.4331|TWO_SIDED|95.0|-7.54|3.41||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|Week 24 to week 48; mITT LOCF. (Physical component score)||3.41|-7.54|0.4331
72468050|NCT03845075|144458779|SUPERIORITY||LS Mean Difference|-1.44||||0.6427|TWO_SIDED|95.0|-7.9|5.03||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|Week 24 to week 48; mITT LOCF. (Mental component score)||5.03|-7.90|0.6427
72468051|NCT03845075|144458781|SUPERIORITY||LS Mean Difference|5.86||||0.3037|TWO_SIDED|95.0|-5.76|17.48||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|From baseline to week 24; safety set LOCF. (Change in systolic blood pressure)||17.48|-5.76|0.3037
72504097|NCT01025336|144539189|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.6|||||TWO_SIDED|95.0|0.43|0.77|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 7F: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.77|0.43|
72504098|NCT01025336|144539189|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.4|||||TWO_SIDED|95.0|0.3|0.6|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 9V: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.60|0.30|
72504099|NCT01025336|144539189|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.7|||||TWO_SIDED|95.0|0.47|0.98|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 9V: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.98|0.47|
72504100|NCT01025336|144539189|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.9|||||TWO_SIDED|95.0|0.72|1.01|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 14: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||1.01|0.72|
72504101|NCT01025336|144539189|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.8|||||TWO_SIDED|95.0|0.71|1.0|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 14: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||1.00|0.71|
72504102|NCT01025336|144539189|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.6|||||TWO_SIDED|95.0|0.5|0.66|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 18C: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.66|0.50|
72468052|NCT03845075|144458781|SUPERIORITY||LS Mean Difference|1.15||||0.7912|TWO_SIDED|95.0|-7.85|10.16||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|From baseline to week 24; safety set LOCF. (Change in diastolic blood pressure)||10.16|-7.85|0.7912
72468053|NCT03845075|144458781|SUPERIORITY||LS Mean Difference|10.29||||0.1773|TWO_SIDED|95.0|-5.25|25.83||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|From baseline to week 48; safety set LOCF. (Change in systolic blood pressure)||25.83|-5.25|0.1773
72468054|NCT03845075|144458781|SUPERIORITY||LS Mean Difference|1.32||||0.798|TWO_SIDED|95.0|-9.55|12.2||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|From baseline to week 48; safety set LOCF. (Change in diastolic blood pressure)||12.20|-9.55|0.7980
72468055|NCT03845075|144458781|SUPERIORITY||LS Mean Difference|7.77||||0.158|TWO_SIDED|95.0|-3.4|18.94||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|From week 24 to week 48; safety set LOCF. (Change in systolic blood pressure)||18.94|-3.40|0.1580
72468056|NCT03845075|144458781|SUPERIORITY||LS Mean Difference|1.64||||0.7021|TWO_SIDED|95.0|-7.36|10.64||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|From week 24 to week 48; safety set LOCF. (Change in diastolic blood pressure)||10.64|-7.36|0.7021
72504103|NCT01025336|144539189|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.7|||||TWO_SIDED|95.0|0.56|0.8|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 18C: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.80|0.56|
72504104|NCT01025336|144539189|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.6|||||TWO_SIDED|95.0|0.54|0.69|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 19A: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.69|0.54|
72504105|NCT01025336|144539189|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.9|||||TWO_SIDED|95.0|0.78|1.05|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 19A: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||1.05|0.78|
72564922|NCT00440466|144661356|NON_INFERIORITY_OR_EQUIVALENCE|Assuming a difference in the mean change in hemoglobin from baseline to the average of the last 12 weeks of treatment of -0.3 g/dL between QW and Q2W groups, a pooled standard deviation of 1.5 g/dL, and a noninferiority margin of 1 g/dL, a sample size of approximately 200 subjects (100 per group) would provide 90% power to demonstrate that Q2W group would not inferior to QW group for an overall 2-sided 0.05 significance level.|Difference of Least Squares Means|-0.03|STANDARD_ERROR_OF_MEAN|0.092|||TWO_SIDED|95.0|-0.208|0.153|||ANCOVA|||The null hypothesis was that the lower limit of the 95% confidence interval (CI) for the difference in mean change in hemoglobin from baseline to the average of the last 12 weeks of treatment between the every-2-weeks (Q2W) and once-weekly (QW) groups would be lower than -1 g/dL.||0.153|-0.208|
72564923|NCT00440466|144661356|NON_INFERIORITY_OR_EQUIVALENCE|Under the same assumptions in the sample size calculation for the QW and the Q2W, 100 subjects would be needed for the Q4W. However, because Study EPO-AKD-3001 and the current study both included QW and Q2W groups, the sample size would add up to 200 for each group if combined, the sample size in the Q4W group in the current study was increased to 200 subjects in order to enroll a comparable and sufficiently large number of subjects in each of the 3 extended dosing groups across the 2 studies.|Difference of Least Squares Means|-0.09|STANDARD_ERROR_OF_MEAN|0.079|||TWO_SIDED|95.0|-0.249|0.063|||ANCOVA|||The null hypothesis was that the lower limit of the 95% confidence interval (CI) for the difference in mean change in hemoglobin from baseline to the average of the last 12 weeks of treatment between the every-4-weeks (Q4W) and once-weekly (QW) groups would be lower than -1 g/dL.||0.063|-0.249|
72564924|NCT00440466|144661358|SUPERIORITY_OR_OTHER||Difference in percentage of participants|10.9|||||TWO_SIDED|95.0|0.1|21.7|||95% Confidence Interval|||||21.7|0.1|
72564925|NCT00440466|144661358|SUPERIORITY_OR_OTHER||Difference in percentage of participants|1.1|||||TWO_SIDED|95.0|-9.1|11.2|||95% of Confidence Interval|||||11.2|-9.1|
72564926|NCT00440466|144661359|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|0.13|||||TWO_SIDED|95.0|-0.113|0.372|||ANOVA|||||0.372|-0.113|
72564927|NCT00440466|144661359|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|0.11|||||TWO_SIDED|95.0|-0.098|0.32|||ANOVA|||||0.320|-0.098|
72564928|NCT00440466|144661360|SUPERIORITY_OR_OTHER||Difference in percentage of participants|8.2|||||TWO_SIDED|95.0|-2.0|18.3|||95% of Confidence Interval|||||18.3|-2.0|
72564929|NCT00440466|144661360|SUPERIORITY_OR_OTHER||Difference in percentage of participants|10.3||||||95.0|1.5|19.2|||95% of Confidence Interval|||||19.2|1.5|
72564930|NCT00440466|144661361|SUPERIORITY_OR_OTHER||Difference in percentage of participants|5.7|||||TWO_SIDED|95.0|-7.7|19.1|||95% of Confidence Interval|||||19.1|-7.7|
72564931|NCT00440466|144661361|SUPERIORITY_OR_OTHER||Difference in percentage of participants|9.1|||||TWO_SIDED|95.0|-2.5|20.6|||95% of Confidence Interval|||||20.6|-2.5|
72564932|NCT00440466|144661362|SUPERIORITY_OR_OTHER||Difference in percentage of participants|-3.2|||||TWO_SIDED|95.0|-15.8|9.5|||95% of Confidence Interval|||||9.5|-15.8|
72564933|NCT00440466|144661362|SUPERIORITY_OR_OTHER||Difference in percentage of participants|-3.0|||||TWO_SIDED|95.0|-13.9|8.0|||95% of Confidence Interval|||||8.0|-13.9|
72564934|NCT00440466|144661363|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-0.08||||||95.0|-0.367|0.208|||ANOVA|||||0.208|-0.367|
72394635|NCT02310568|144295797|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|1.28||0.574|TWO_SIDED|90.0|-2.9|1.4|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 2: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||1.4|-2.9|0.574
72394636|NCT02310568|144295797|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|1.09||0.831|TWO_SIDED|90.0|-2.1|1.6|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - Placebo). Week 3: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||1.6|-2.1|0.831
72468057|NCT03845075|144458782|SUPERIORITY||LS Mean Difference|1.5||||0.8728|TWO_SIDED|95.0|-18.17|21.18||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|From baseline to week 24; mITT LOCF. (Change in systolic blood pressure mean)||21.18|-18.17|0.8728
72468058|NCT03845075|144458782|SUPERIORITY||LS Mean Difference|2.46||||0.5714|TWO_SIDED|95.0|-6.61|11.54||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|From baseline to week 24; mITT LOCF. (Change in diastolic blood pressure mean)||11.54|-6.61|0.5714
72468059|NCT03845075|144458782|SUPERIORITY||LS Mean Difference|-10.15||||0.2322|TWO_SIDED|95.0|-27.51|7.22||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|From baseline to week 12; mITT LOCF. (Change in systolic blood pressure mean)||7.22|-27.51|0.2322
72468060|NCT03845075|144458782|SUPERIORITY||LS Mean Difference|-3.46||||0.4321|TWO_SIDED|95.0|-12.61|5.68||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|From baseline to week 12; mITT LOCF. (Change in diastolic blood pressure mean)||5.68|-12.61|0.4321
72468061|NCT03845075|144458785|SUPERIORITY||LS Mean Difference|2.7||||0.5551|TWO_SIDED|95.0|-6.72|12.12||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|From baseline to week 24; safety set LOCF. (Change in heart rate)||12.12|-6.72|0.5551
72504106|NCT01025336|144539189|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.7|||||TWO_SIDED|95.0|0.59|0.8|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 19F: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.80|0.59|
72504107|NCT01025336|144539189|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.7|||||TWO_SIDED|95.0|0.53|0.83|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 19F: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.83|0.53|
72504108|NCT01025336|144539189|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.6|||||TWO_SIDED|95.0|0.51|0.74|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 23F: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.74|0.51|
72564935|NCT00440466|144661363|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|0.04|||||TWO_SIDED|95.0|-0.206|0.289|||ANOVA|||||0.289|-0.206|
72564936|NCT01286558|144661391|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.46||||||95.0|-0.22|3.14|||ANCOVA|||||3.14|-0.22|
72564937|NCT01286558|144661392|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.14||||||95.0|-0.36|4.64|||ANCOVA|||||4.64|-0.36|
72564938|NCT01286558|144661393|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.21||||||95.0|-2.58|0.15|||ANCOVA|||||0.15|-2.58|
72394637|NCT02310568|144295797|SUPERIORITY_OR_OTHER||LS Mean Difference|0.4|STANDARD_ERROR_OF_MEAN|1.1||0.705|TWO_SIDED|90.0|-1.4|2.3|||Mixed-Effects Model Repeated Measure|||(PF-06372865 2.5 mg - Placebo). Week 3: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||2.3|-1.4|0.705
72394638|NCT02310568|144295797|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|1.24||0.6|TWO_SIDED|90.0|-2.7|1.4|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 3: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||1.4|-2.7|0.600
72504109|NCT01025336|144539189|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.9|||||TWO_SIDED|95.0|0.75|1.15|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 23F: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||1.15|0.75|
72504110|NCT01025336|144539190|SUPERIORITY_OR_OTHER||geometric mean fold rise|8.0|||||TWO_SIDED|95.0|6.05|10.67|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 1: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||10.67|6.05|
72564939|NCT01286558|144661394|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.9||||||95.0|-4.16|0.35|||ANCOVA|||||0.35|-4.16|
72564940|NCT01286558|144661395|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.89||||||95.0|-2.57|0.79|||ANCOVA|||||0.79|-2.57|
72564941|NCT01286558|144661396|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.64||||||95.0|-4.27|0.99|||ANCOVA|||||0.99|-4.27|
72468062|NCT03845075|144458785|SUPERIORITY||LS Mean Difference|-2.13||||0.7256|TWO_SIDED|95.0|-14.88|10.63||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|From baseline to week 48; safety set LOCF. (Change in heart rate)||10.63|-14.88|0.7256
72468063|NCT03845075|144458785|SUPERIORITY||LS Mean Difference|-3.29||||0.4822|TWO_SIDED|95.0|-13.05|6.48||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|From week 24 to week 48; safety set LOCF. (Change in heart rate)||6.48|-13.05|0.4822
72468064|NCT00935259|144458786|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.4|STANDARD_DEVIATION|52.1||0.455||95.0||||Endpoint was analyzed as appropriate for a 2-period crossover model using a mixed model with fixed terms of period and treatment with participants as a random factor.|Mixed Models Analysis|An unstructured covariance and Kenward Roger degrees of freedom were assumed.||||||0.455
72468065|NCT00935259|144458787|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-51.7||||0.014||95.0||||Endpoint was analyzed as appropriate for a 2-period crossover model using a mixed model with fixed terms of period and treatment with participants as a random factor.|Mixed Models Analysis|An unstructured covariance and Kenward Roger degrees of freedom were assumed.||Cholesterol Ester 16:00||||0.014
72468066|NCT00935259|144458787|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.5|||<|0.001||95.0||||Endpoint was analyzed as appropriate for a 2-period crossover model using a mixed model with fixed terms of period and treatment with participants as a random factor.|Mixed Models Analysis|An unstructured covariance and Kenward Roger degrees of freedom were assumed.||Cholesterol Ester 18:3n3||||<0.001
72468067|NCT00935259|144458787|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.5||||0.217||95.0||||Endpoint was analyzed as appropriate for a 2-period crossover model using a mixed model with fixed terms of period and treatment with participants as a random factor.|Mixed Models Analysis|An unstructured covariance and Kenward Roger degrees of freedom were assumed.||Cholesterol Ester 20:3n6||||0.217
72468068|NCT00935259|144458787|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||0.666||95.0||||Endpoint was analyzed as appropriate for a 2-period crossover model using a mixed model with fixed terms of period and treatment with participants as a random factor.|Mixed Models Analysis|An unstructured covariance and Kenward Roger degrees of freedom were assumed.||Cholesterol Ester 20:3n9||||0.666
72468069|NCT00935259|144458787|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.776||95.0||||Endpoint was analyzed as appropriate for a 2-period crossover model using a mixed model with fixed terms of period and treatment with participants as a random factor.|Mixed Models Analysis|An unstructured covariance and Kenward Roger degrees of freedom were assumed.||Cholesterol Ester 22:5n6||||0.776
72468070|NCT00935259|144458787|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.5||||0.018||95.0||||Endpoint was analyzed as appropriate for a 2-period crossover model using a mixed model with fixed terms of period and treatment with participants as a random factor.|Mixed Models Analysis|An unstructured covariance and Kenward Roger degrees of freedom were assumed.||Cholesterol Ester 22:6n3||||0.018
72468071|NCT00935259|144458787|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.1||||0.152||95.0||||Endpoint was analyzed as appropriate for a 2-period crossover model using a mixed model with fixed terms of period and treatment with participants as a random factor.|Mixed Models Analysis|An unstructured covariance and Kenward Roger degrees of freedom were assumed.||Lysophosphatidylcholine 20:4n6||||0.152
72468072|NCT00935259|144458787|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-132.1||||0.007||95.0||||Endpoint was analyzed as appropriate for a 2-period crossover model using a mixed model with fixed terms of period and treatment with participants as a random factor.|Mixed Models Analysis|An unstructured covariance and Kenward Roger degrees of freedom were assumed.||Phosphatidylcholine 18:2n6||||0.007
72504111|NCT01025336|144539190|SUPERIORITY_OR_OTHER||geometric mean fold rise|8.3|||||TWO_SIDED|95.0|6.65|10.45|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 1: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||10.45|6.65|
72468073|NCT00935259|144458787|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.8||||0.325||95.0||||Endpoint was analyzed as appropriate for a 2-period crossover model using a mixed model with fixed terms of period and treatment with participants as a random factor.|Mixed Models Analysis|An unstructured covariance and Kenward Roger degrees of freedom were assumed.||Phosphatidylcholine 20:3n6||||0.325
72468074|NCT00935259|144458787|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|18.3||||0.419||95.0||||Endpoint was analyzed as appropriate for a 2-period crossover model using a mixed model with fixed terms of period and treatment with participants as a random factor.|Mixed Models Analysis|An unstructured covariance and Kenward Roger degrees of freedom were assumed.||Phosphatidylcholine 20:4n6||||0.419
72468075|NCT00935259|144458787|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.7||||0.07||95.0||||Endpoint was analyzed as appropriate for a 2-period crossover model using a mixed model with fixed terms of period and treatment with participants as a random factor.|Mixed Models Analysis|An unstructured covariance and Kenward Roger degrees of freedom were assumed.||Phosphatidylcholine 22:5n3||||0.070
72504112|NCT01025336|144539190|SUPERIORITY_OR_OTHER||geometric mean fold rise|4.8|||||TWO_SIDED|95.0|3.71|6.14|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 1: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||6.14|3.71|
72621897|NCT01946880|144774202|OTHER|The estimated risk difference (i.e. risk(MMF Withdrawal) - risk(MMF Maintenance)) and 95% confidence intervals around the risk difference at Week 60 were reported using the Kaplan-Meier product-limit estimator.|Risk Difference (RD)|0.08|||||TWO_SIDED|95.0|-0.056|0.211||||||||0.211|-0.056|
72504113|NCT01025336|144539190|SUPERIORITY_OR_OTHER||geometric mean fold rise|3.2|||||TWO_SIDED|95.0|2.59|3.91|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 3: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||3.91|2.59|
72468076|NCT00935259|144458787|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2||||0.769||95.0||||Endpoint was analyzed as appropriate for a 2-period crossover model using a mixed model with fixed terms of period and treatment with participants as a random factor.|Mixed Models Analysis|An unstructured covariance and Kenward Roger degrees of freedom were assumed.||Phosphatidylcholine 22:5n6||||0.769
72468077|NCT00935259|144458787|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.1|||<|0.001||95.0||||Endpoint was analyzed as appropriate for a 2-period crossover model using a mixed model with fixed terms of period and treatment with participants as a random factor.|Mixed Models Analysis|An unstructured covariance and Kenward Roger degrees of freedom were assumed.||Phosphatidylethanolamine 18:2n6||||<0.001
72468078|NCT00935259|144458787|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-240.8||||0.016||95.0||||Endpoint was analyzed as appropriate for a 2-period crossover model using a mixed model with fixed terms of period and treatment with participants as a random factor.|Mixed Models Analysis|An unstructured covariance and Kenward Roger degrees of freedom were assumed.||Triacylglycerol 16:00||||0.016
72468079|NCT00935259|144458787|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||0.833||95.0||||Endpoint was analyzed as appropriate for a 2-period crossover model using a mixed model with fixed terms of period and treatment with participants as a random factor.|Mixed Models Analysis|An unstructured covariance and Kenward Roger degrees of freedom were assumed.||Triacylglycerol 20:3n9||||0.833
72468080|NCT00935259|144458788|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.9||||0.027||95.0||||Endpoint was analyzed as appropriate for a 2-period crossover model using a mixed model with fixed terms of period and treatment with participants as a random factor.|Mixed Models Analysis|An unstructured covariance and Kenward Roger degrees of freedom were assumed.||Fasted||||0.027
72468081|NCT00935259|144458788|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.4|||<|0.001||95.0||||Endpoint was analyzed as appropriate for a 2-period crossover model using a mixed model with fixed terms of period and treatment with participants as a random factor.|Mixed Models Analysis|An unstructured covariance and Kenward Roger degrees of freedom were assumed.||Fed||||<0.001
72468082|NCT00935259|144458790|SUPERIORITY_OR_OTHER|||||||0.247||95.0|||||Mixed Models Analysis|||Cholesterol ester c20:4n6 / c20:3n6||||0.247
72468083|NCT00935259|144458790|SUPERIORITY_OR_OTHER|||||||0.151||95.0|||||Mixed Models Analysis|||Cholesterol ester c20:5n3 / c20:4n3||||0.151
72468084|NCT04353817|144458794|SUPERIORITY||Least Squares (LS) Mean Difference|-2.26|||<|0.0001|TWO_SIDED|95.0|-2.71|-1.81|||Mixed-effects Model for Repeated Measure|||||-1.81|-2.71|<0.0001
72468085|NCT04353817|144458795|SUPERIORITY||LS Mean Difference|-51.2|||<|0.0001|TWO_SIDED|95.0|-55.3|-47.1||This is the nominal p-value without multiplicity controlled.|Mixed-effects Model for Repeated Measure|||||-47.1|-55.3|<0.0001
72468086|NCT00002597|144458797|SUPERIORITY||Hazard Ratio (HR)|1.17||||0.0309|TWO_SIDED|95.0|1.01|1.35|||Log Rank||Reference level = Hormone Therapy + Radiation Therapy|Null hypothesis: 8-year OS rate of 60% radiation therapy (RT) alone vs. 67% with hormone therapy. The study was designed with 90% power to detect a 7-percentage- point absolute difference in the 8-year survival rate, with the use of a one-sided log-rank test at the 0.025 significance level, requiring 1980 patients and 716 deaths for definitive analysis.||1.35|1.01|0.0309
72468087|NCT00002597|144458798|SUPERIORITY||Hazard Ratio (HR)|1.86||||0.001|TWO_SIDED|95.0|1.27|2.74|||Gray's test||Reference level = Hormone Therapy + Radiation Therapy|Gray's test was used to compare cumulative incidence between treatment arms (1-sided significance level of 0.025) and the Fine-Gray model was used to calculate hazard ratios.||2.74|1.27|0.001
72468088|NCT00002597|144458799|SUPERIORITY||Hazard Ratio (HR)|1.5||||0.0013|TWO_SIDED|95.0|1.17|1.93|||Gray's test||Reference level = Hormone Therapy + Radiation Therapy|Gray's test was used to compare cumulative incidence between treatment arms (1-sided significance level of 0.025) and the Fine-Gray model was used to calculate hazard ratios.||1.93|1.17|0.0013
72468089|NCT00002597|144458800|SUPERIORITY||Hazard Ratio (HR)|1.45||||0.035|TWO_SIDED|95.0|1.03|2.06|||Gray's test||Reference level = Hormone Therapy + Radiation Therapy|Gray's test was used to compare cumulative incidence between treatment arms (1-sided significance level of 0.025) and the Fine-Gray model was used to calculate hazard ratios.||2.06|1.03|0.035
72468090|NCT00002597|144458801|SUPERIORITY||Hazard Ratio (HR)|1.74|||<|0.001|TWO_SIDED|95.0|1.48|2.04|||Gray's test||Reference level = Hormone Therapy + Radiation Therapy|Gray's test was used to compare cumulative incidence between treatment arms (1-sided significance level of 0.025) and the Fine-Gray model was used to calculate hazard ratios.||2.04|1.48|<0.001
72468091|NCT00002597|144458802|SUPERIORITY||Hazard Ratio (HR)|1.5|||<|0.001|TWO_SIDED|95.0|1.21|1.85|||Gray's test||Reference level = Hormone Therapy + Radiation Therapy|Gray's test was used to compare cumulative incidence between treatment arms (1-sided significance level of 0.025) and the Fine-Gray model was used to calculate hazard ratios.||1.85|1.21|<0.001
72468092|NCT00002597|144458803|SUPERIORITY||Hazard Ratio (HR)|2.06|||<|0.001|TWO_SIDED|95.0|1.34|3.16|||Gray's test||Reference level = Hormone Therapy + Radiation Therapy|Gray's test was used to compare cumulative incidence between treatment arms (1-sided significance level of 0.025) and the Fine-Gray model was used to calculate hazard ratios.||3.16|1.34|<0.001
72504114|NCT01025336|144539190|SUPERIORITY_OR_OTHER||geometric mean fold rise|4.4|||||TWO_SIDED|95.0|3.67|5.26|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 3: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||5.26|3.67|
72504115|NCT01025336|144539190|SUPERIORITY_OR_OTHER||geometric mean fold rise|2.6|||||TWO_SIDED|95.0|2.2|3.14|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 3: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||3.14|2.20|
72468093|NCT00002597|144458804|SUPERIORITY||Hazard Ratio (HR)|1.38|||<|0.001|TWO_SIDED|95.0|1.22|1.56|||Log Rank||Reference level = Hormone Therapy + Radiation Therapy|Treatment arms were compared using the log-rank test (one-sided significance level of 0.025).||1.56|1.22|<0.001
72468094|NCT00002597|144458805|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
72468095|NCT02654132|144458806|SUPERIORITY||Hazard Ratio (HR)|0.51||||0.0043|TWO_SIDED|95.0|0.32|0.82|||Log Rank|||||0.82|0.32|0.0043
72468096|NCT02654132|144458807|SUPERIORITY||Odds Ratio (OR)|4.62||||0.0002|TWO_SIDED|95.0|2.05|10.43|||Cochran-Mantel-Haenszel|||||10.43|2.05|0.0002
72468097|NCT02654132|144458808|SUPERIORITY||Hazard Ratio (HR)|0.59||||0.0217|TWO_SIDED|95.0|0.37|0.93|||Log Rank|||||0.93|0.37|0.0217
72468098|NCT02485899|144458837|OTHER||Hazard Ratio (HR)|0.14|||<|0.0001|TWO_SIDED|95.0|0.06|0.33|||Cox Proportional Hazards model|||||0.33|0.06|<0.0001
72468099|NCT02485899|144458838|OTHER||Hazard Ratio (HR)|0.01|||<|0.0001|TWO_SIDED||||||Cox Proportional Hazards model|||||||<0.0001
72468100|NCT00823836|144458886|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority of ropinirole PR/XR tablets to ropinirole IR tablets was assessed with a non-inferiority margin of 2.5.|Median Difference (Net)|0.34||||0.702|TWO_SIDED|95.0|-1.41|2.09||Analysis of covariance (ANCOVA) model: value of change from Week 0 at Week 24 = treatment group + Week 0 value|ANCOVA|||||2.09|-1.41|0.702
72468101|NCT02271230|144458948|SUPERIORITY||Hazard Ratio (HR)|0.93|||||TWO_SIDED|95.0|0.78|1.11||||||||1.11|0.78|
72468102|NCT02271230|144458948|SUPERIORITY||Hazard Ratio (HR)|0.96|||||TWO_SIDED|95.0|0.8|1.14||||||||1.14|0.80|
72468103|NCT02271230|144458949|SUPERIORITY||Hazard Ratio (HR)|0.94|||||TWO_SIDED|95.0|0.81|1.09||||||||1.09|0.81|
72468104|NCT02271230|144458949|SUPERIORITY||Hazard Ratio (HR)|0.86|||||TWO_SIDED|95.0|0.74|0.998||||||||0.998|0.74|
72564942|NCT00418522|144661416|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority test utilized a one-sided 2.5% level of significance.|Mean Difference (Final Values)|-0.19|||<|0.0001||95.0|-0.38|0.0|||ANCOVA||A confidence interval (CI) approach was presented with a two-sided 95% CI of the difference between treatment and control.|The null hypothesis was that the inhaled human insulin group was inferior to the insulin glargine group with respect to 26-week change from baseline in HbA1c, while the alternate hypothesis is that the inhaled human insulin group was not inferior to the insulin glargine group with respect to 26-week change from baseline in HbA1c, given the predetermined non-inferiority margin of 0.4%.||0|-0.38|<0.0001
72468105|NCT03042299|144458957|EQUIVALENCE|The difference in the least square (LS) means between formulations (TAK-536 pediatric formulation \[granules\]-TAK-536 commercial formulation \[tablet\]) and the two-sided 90 percent (%) confidence interval (CI) were provided using a crossover analysis of variance (ANOVA) model. The ANOVA model included log-transformed (natural log) PK parameters AUC 48 as dependent variable, and formulation, group, and period as independent variables.|Point estimate|-0.0731|||||TWO_SIDED|90.0|-0.1088|-0.0373||||||||-0.0373|-0.1088|
72468106|NCT03042299|144458958|EQUIVALENCE|The difference in the LS means between formulations (TAK-536 pediatric formulation \[granules\]-TAK-536 commercial formulation \[tablet\]) and the two-sided 90% CI were provided using a crossover ANOVA model. The ANOVA model included log-transformed (natural log) PK parameters Cmax as dependent variable, and formulation, group, and period as independent variables.|Point estimate|-0.0909|||||TWO_SIDED|90.0|-0.1573|-0.0244||||||||-0.0244|-0.1573|
72468107|NCT01438840|144458968|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
72564943|NCT00418522|144661416|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.19||||0.0516||95.0|-0.38|0.0|||ANCOVA||The superiority test used a one-sided 2.5% level of significance.|With an established non-inferiority claim, an additional test for superiority was conducted (ie, the margin was 0.0%).||0|-0.38|0.0516
72564944|NCT00418522|144661417|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.96||||0.0052||95.0|1.22|3.14|||Regression, Logistic|||||3.14|1.22|0.0052
72621898|NCT01946880|144774203|OTHER|The estimated risk difference (i.e. risk(MMF Withdrawal) - risk(MMF Maintenance)) and 95% confidence intervals around the risk difference at Week 60 were reported using the Kaplan-Meier product-limit estimator.|Risk Difference (RD)|0.12|||||TWO_SIDED|95.0|-0.041|0.284||||||||0.284|-0.041|
72621899|NCT01946880|144774204|OTHER|The estimated risk difference (i.e. risk(MMF Withdrawal) - risk(MMF Maintenance)) and 95% confidence intervals around the risk difference at Week 60 were reported using the Kaplan-Meier product-limit estimator.|Risk Difference (RD)|-0.04|||||TWO_SIDED|95.0|-0.285|0.206||||||||0.206|-0.285|
72468108|NCT02804399|144458979|SUPERIORITY_OR_OTHER||Ratio of Geometric Mean|14.74|||||TWO_SIDED|90.0|12.78|17.01||||||Mixed model was fitted to obtain ratio of geometric means of Rifampin 600 mg QD + PF-06463922 100 mg SD (test) to PF-06463922 100 mg SD (reference) and the results are presented as percentage. 90% CI was calculated on ratio of geometric means.||17.01|12.78|
72468109|NCT02804399|144458980|SUPERIORITY_OR_OTHER||Ratio of Geometric Mean|23.88|||||TWO_SIDED|90.0|21.58|26.43||||||Mixed model was fitted to obtain ratio of geometric means of Rifampin 600 mg QD + PF-06463922 100 mg SD (test) to PF-06463922 100 mg SD (reference) and the results are presented as percentage. 90% CI was calculated on ratio of geometric means.||26.43|21.58|
72468110|NCT02804399|144458981|SUPERIORITY_OR_OTHER||Ratio of Geometric Mean|13.96|||||TWO_SIDED|90.0|12.09|16.12||||||Mixed model was fitted to obtain ratio of geometric means of Rifampin 600 mg QD + PF-06463922 100 mg SD (test) to PF-06463922 100 mg SD (reference) and the results are presented as percentage. 90% CI was calculated on ratio of geometric means.||16.12|12.09|
72468111|NCT04211389|144459002|SUPERIORITY||Odds Ratio (OR)|6.59|||<|0.0001|TWO_SIDED|95.0|3.17|13.7||Stratification by pooled study site, baseline IGA, and baseline intertriginous involvement per randomization with multiple imputation of missing data.|Cochran-Mantel-Haenszel||Common OR stratified by pooled study site, baseline IGA, and baseline intertriginous involvement per randomization with multiple imputation of missing data.|IGA Success at Week 8 Odds Ratio||13.70|3.17|<0.0001
72468112|NCT04211389|144459003|SUPERIORITY||Hazard Ratio (HR)|4.207|||<|0.0001|TWO_SIDED|95.0|3.029|5.844|||Log Rank|Unstratified log-rank test|HR stratified by pooled study site, baseline IGA, and baseline intertriginous involvement per randomization.|Time to Achieve PASI-50||5.844|3.029|<0.0001
72468113|NCT04211389|144459004|SUPERIORITY||Odds Ratio (OR)|10.42|||<|0.0001|TWO_SIDED|95.0|4.49|24.19|||Cochran-Mantel-Haenszel|Stratified by pooled study site, baseline IGA, and baseline intertriginous involvement per randomization with multiple imputation of missing data.|Common OR stratified by pooled study site, baseline IGA, and baseline intertriginous involvement per randomization with multiple imputation of missing data.|PASI-75 at Week 8 Odds Ratio||24.19|4.49|<0.0001
72564945|NCT00418522|144661418|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.01||||0.0022||95.0|1.29|3.15|||Regression, Logistic|||||3.15|1.29|0.0022
72564946|NCT00418522|144661419|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.71||||0.248||95.0|0.4|1.27|||Regression, Logistic|||||1.27|0.40|0.2480
72564947|NCT00418522|144661420|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.57||||0.6091||95.0|-7.31|12.46|||ANCOVA|||||12.46|-7.31|0.6091
72468114|NCT04211389|144459005|SUPERIORITY||Odds Ratio (OR)|8.51||||0.0002|TWO_SIDED|95.0|2.45|28.86|||Cochran-Mantel-Haenszel|Stratified by pooled study site, baseline IGA, and baseline intertriginous involvement per randomization with multiple imputation of missing data.|Common OR stratified by pooled study site, baseline IGA, and baseline intertriginous involvement per randomization with multiple imputation of missing data.|PASI-90 at Week 8 Odds Ratio||28.86|2.45|0.0002
72468115|NCT04211389|144459006|SUPERIORITY||Odds Ratio (OR)|11.18||||0.0004|TWO_SIDED|95.0|2.33|53.68|||Cochran-Mantel-Haenszel|Stratified by pooled study site and baseline IGA per randomization with multiple imputation of missing data.|Common OR stratified by pooled study site and baseline IGA per randomization with multiple imputation of missing data.|I-IGA Success at Week 8 Odds Ratio||53.68|2.33|0.0004
72468116|NCT04211389|144459007|SUPERIORITY||Odds Ratio (OR)|15.27||||0.0002|TWO_SIDED|95.0|3.1|75.35|||Cochran-Mantel-Haenszel|Stratified by pooled study site and baseline IGA with multiple imputation of missing data.|Common odds ratio stratified by pooled study site and baseline IGA with multiple imputation of missing data.|I-IGA Clear at Week 8 Odds Ratio||75.35|3.10|0.0002
72468117|NCT04211389|144459008|SUPERIORITY|WI-NRS Success at Week 2 Odds Ratio|Odds Ratio (OR)|2.56||||0.0026|TWO_SIDED|95.0|1.43|4.58|||Cochran-Mantel-Haenszel|Stratified by pooled study site, baseline IGA, and baseline intertriginous involvement per randomization with multiple imputation of missing data.|Common OR stratified by pooled study site, baseline IGA, and baseline intertriginous involvement per randomization with multiple imputation of missing data.|||4.58|1.43|0.0026
72468118|NCT04211389|144459008|SUPERIORITY|WI-NRS Success at Week 4 Odds Ratio|Odds Ratio (OR)|4.93|||<|0.0001|TWO_SIDED|95.0|2.65|9.18|||Cochran-Mantel-Haenszel|Stratified by pooled study site, baseline IGA, and baseline intertriginous involvement per randomization with multiple imputation of missing data.|Common OR stratified by pooled study site, baseline IGA, and baseline intertriginous involvement per randomization with multiple imputation of missing data.|||9.18|2.65|<0.0001
72468119|NCT04211389|144459008|SUPERIORITY|WI-NRS Success at Week 8 Odds Ratio|Odds Ratio (OR)|3.59|||<|0.0001|TWO_SIDED|95.0|2.07|6.23|||Cochran-Mantel-Haenszel|Stratified by pooled study site, baseline IGA, and baseline intertriginous involvement per randomization with multiple imputation of missing data.|Common OR stratified by pooled study site, baseline IGA, and baseline intertriginous involvement per randomization with multiple imputation of missing data.|||6.23|2.07|<0.0001
72468120|NCT04211389|144459009|SUPERIORITY||Mean Difference (Final Values)|-26.0|||<|0.0001|TWO_SIDED|95.0|-31.9|-20.0|||ANCOVA|Site, baseline IGA, baseline intertriginous involvement, and baseline PSD scores were independent variables, multiple imputation used for missing data|Site, baseline IGA, baseline intertriginous involvement, and baseline PSD scores were independent variables, multiple imputation used for missing data|LS Mean Difference at Week 4||-20.0|-31.9|<0.0001
72468121|NCT04211389|144459009|SUPERIORITY||Mean Difference (Final Values)|-26.5|||<|0.0001|TWO_SIDED|95.0|-33.2|-19.7|||ANCOVA|Site, baseline IGA, baseline intertriginous involvement, and baseline PSD scores were independent variables, multiple imputation used for missing data|Site, baseline IGA, baseline intertriginous involvement, and baseline PSD scores were independent variables, multiple imputation used for missing data|LS Mean Difference at Week 8||-19.7|-33.2|<0.0001
72468122|NCT02357264|144459010|OTHER|||||||0.162|||||||Fisher Exact|||||||.162
72468123|NCT01062971|144459019|NON_INFERIORITY|Noninferiority was determined if the treatments did not show differences greater than 20%||||||0.001|||||||Wilcoxon (Mann-Whitney)|||||||0.001
72621900|NCT01946880|144774205|OTHER|The estimated risk difference (i.e. risk(MMF Withdrawal) - risk(MMF Maintenance)) and 95% confidence intervals around the risk difference at Week 60 were reported using the Kaplan-Meier product-limit estimator.|Risk Difference (RD)|0.09|||||TWO_SIDED|95.0|-0.118|0.289||||||||0.289|-0.118|
72468124|NCT01062971|144459020|NON_INFERIORITY|Noninferiority was determined if the treatments did not show differences greater than 20%.|||||>|0.05|||||||t-test, 2 sided|||||||>0.05
72468125|NCT01182207|144459026|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|96.74|||||TWO_SIDED|90.0|86.82|107.79|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||107.79|86.82|
72468126|NCT01182207|144459027|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|103.16|||||TWO_SIDED|90.0|101.1|105.27|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||105.27|101.10|
72468127|NCT01182207|144459028|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|102.72|||||TWO_SIDED|90.0|100.67|104.8|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||104.80|100.67|
72621901|NCT01946880|144774206|OTHER|The estimated risk difference (i.e. risk(MMF Withdrawal) - risk(MMF Maintenance)) and 95% confidence intervals around the risk difference at Week 60 were reported using the Kaplan-Meier product-limit estimator.|Risk Difference (RD)|0.05|||||TWO_SIDED|95.0|-0.103|0.212||||||||0.212|-0.103|
72621902|NCT01946880|144774209|OTHER|The estimated risk difference (i.e. risk(MMF Withdrawal) - risk(MMF Maintenance)) and 95% confidence intervals around the risk difference at Week 60 were reported using the Kaplan-Meier product-limit estimator.|Risk Difference (RD)|0.06|||||TWO_SIDED|95.0|-0.028|0.149||||||||0.149|-0.028|
72468128|NCT01182207|144459029|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|97.6|||||TWO_SIDED|90.0|89.45|106.5|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||106.50|89.45|
72468129|NCT01182207|144459030|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|98.88|||||TWO_SIDED|90.0|95.62|102.25|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||102.25|95.62|
72468130|NCT01182207|144459031|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|98.2|||||TWO_SIDED|90.0|95.36|101.12|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||101.12|95.36|
72468131|NCT00097669|144459063|SUPERIORITY|"We used Kaplan-Meier methods to construct cumulative time-to-event curves for the two groups, with a comparison by use of the log-rank test.~We used a Cox proportional hazard model analysis to control for any potential imbalance in baseline characteristics and follow-up between the two groups."|Risk Ratio (RR)|0.91||||0.05|TWO_SIDED|95.0|0.82|1.0|||Log Rank|||||1.00|0.82|0.05
72468132|NCT00097669|144459063|SUPERIORITY||Hazard Ratio (HR)|0.9|||<|0.05|TWO_SIDED|95.0|0.81|1.0|||Regression, Cox|Analysis before adjusting for any potential imbalance in the baseline characteristics and follow-up duration between the groups.||||1.00|0.81|<0.05
72468133|NCT00097669|144459063|SUPERIORITY||Hazard Ratio (HR)|0.91|||<|0.05|TWO_SIDED|95.0|0.81|1.03|||Regression, Cox|Analysis after adjusting for any potential imbalance in the baseline characteristics and follow-up duration between the groups.||||1.03|0.81|<0.05
72468134|NCT02037256|144459065|OTHER||percentage|0.24|||||TWO_SIDED|95.0|0.07|0.5||||||Median time to engraftment||0.50|0.07|
72468135|NCT01657799|144459147|SUPERIORITY|||||||0.933|||||||Log Rank|Log-rank test stratified by graded prognostic assessment (GPA) score (≤ 2.5 or \> 2.5) at screening. Nominal P-values were reported.||The primary analysis used a Hochberg testing procedure to preserve the familywise error rate for multiple comparisons, where the larger P-value for the comparisons of veliparib 50 mg BID + WBRT with placebo BID + WBRT and veliparib 200 mg BID + WBRT with placebo BID + WBRT were compared to an α = 0.05. If statistically significant (P ≤ 0.05), both comparisons were considered significant. If the larger P-value was not statistically significant, the smaller P-value was compared to an α = 0.025.||||0.933
72504116|NCT01025336|144539190|SUPERIORITY_OR_OTHER||geometric mean fold rise|12.9|||||TWO_SIDED|95.0|7.8|21.34|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 4: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||21.34|7.80|
72504117|NCT01025336|144539190|SUPERIORITY_OR_OTHER||geometric mean fold rise|9.0|||||TWO_SIDED|95.0|6.26|12.92|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 4: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||12.92|6.26|
72504118|NCT01025336|144539190|SUPERIORITY_OR_OTHER||geometric mean fold rise|5.5|||||TWO_SIDED|95.0|3.71|8.07|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 4: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||8.07|3.71|
72504119|NCT01025336|144539190|SUPERIORITY_OR_OTHER||geometric mean fold rise|6.2|||||TWO_SIDED|95.0|4.35|8.8|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 5: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||8.80|4.35|
72504120|NCT01025336|144539190|SUPERIORITY_OR_OTHER||geometric mean fold rise|12.6|||||TWO_SIDED|95.0|9.71|16.3|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 5: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||16.30|9.71|
72504121|NCT01025336|144539190|SUPERIORITY_OR_OTHER||geometric mean fold rise|7.5|||||TWO_SIDED|95.0|5.59|10.02|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 5: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||10.02|5.59|
72504122|NCT01025336|144539190|SUPERIORITY_OR_OTHER||geometric mean fold rise|15.1|||||TWO_SIDED|95.0|9.56|23.81|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 6A: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||23.81|9.56|
72504123|NCT01025336|144539190|SUPERIORITY_OR_OTHER||geometric mean fold rise|12.3|||||TWO_SIDED|95.0|8.66|17.38|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 6A: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||17.38|8.66|
72564948|NCT00418522|144661421|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|32.96|||<|0.0001||95.0|22.66|43.25|||ANCOVA|||Time 0 (fasting) at Week 26.||43.25|22.66|<0.0001
72504124|NCT01025336|144539190|SUPERIORITY_OR_OTHER||geometric mean fold rise|6.5|||||TWO_SIDED|95.0|4.29|9.89|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 6A: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||9.89|4.29|
72468136|NCT01657799|144459147|SUPERIORITY|||||||0.909|||||||Log Rank|Log-rank test stratified by GPA score (≤ 2.5 or \> 2.5) at screening. Nominal P-values were reported.||The primary analysis used a Hochberg testing procedure to preserve the familywise error rate for multiple comparisons, where the larger P-value for the comparisons of veliparib 50 mg BID + WBRT with placebo BID + WBRT and veliparib 200 mg BID + WBRT with placebo BID + WBRT were compared to an α = 0.05. If statistically significant (P ≤ 0.05), both comparisons were considered significant. If the larger P-value was not statistically significant, the smaller P-value was compared to an α = 0.025.||||0.909
72468137|NCT01657799|144459147|SUPERIORITY||Hazard Ratio (HR)|0.985||||0.927|TWO_SIDED|95.0|0.716|1.355|||Cox proportional hazard model|Cox proportional hazard model stratified by GPA score (≤ 2.5 or \> 2.5) at screening. Nominal P-values were reported.||||1.355|0.716|0.927
72468138|NCT01657799|144459147|SUPERIORITY||Hazard Ratio (HR)|0.981||||0.906|TWO_SIDED|95.0|0.71|1.354|||Cox proportional hazard model|Cox proportional hazard model stratified by GPA score (≤ 2.5 or \> 2.5) at screening. Nominal P-values were reported.||||1.354|0.710|0.906
72468139|NCT01657799|144459148|SUPERIORITY|||||||0.535|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test stratified by GPA score (≤ 2.5 or \> 2.5) at screening.||||||0.535
72468140|NCT01657799|144459148|SUPERIORITY|||||||0.898|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test stratified by GPA score (≤ 2.5 or \> 2.5) at screening.||||||0.898
72468141|NCT01657799|144459149|SUPERIORITY|||||||0.314|||||||Log Rank|Log-rank test stratified by GPA score (≤ 2.5 or \> 2.5) at screening.||||||0.314
72468142|NCT01657799|144459149|SUPERIORITY|||||||0.536|||||||Log Rank|Log-rank test stratified by GPA score (≤ 2.5 or \> 2.5) at screening.||||||0.536
72468143|NCT01657799|144459149|SUPERIORITY||Hazard Ratio (HR)|1.301||||0.313|TWO_SIDED|95.0|0.78|2.168|||Cox proportional hazard model|Cox proportional hazard model stratified by GPA score (≤ 2.5 or \> 2.5) at screening.||||2.168|0.780|0.313
72468144|NCT01657799|144459149|SUPERIORITY||Hazard Ratio (HR)|1.181||||0.534|TWO_SIDED|95.0|0.698|1.999|||Cox proportional hazard model|Cox proportional hazard model stratified by GPA score (≤ 2.5 or \> 2.5) at screening.||||1.999|0.698|0.534
72468145|NCT01657799|144459150|SUPERIORITY|||||||0.864|||||||Log Rank|Log-rank test stratified by GPA score (≤ 2.5 or \> 2.5) at screening.||||||0.864
72468146|NCT01657799|144459150|SUPERIORITY|||||||0.301|||||||Log Rank|Log-rank test stratified by GPA score (≤ 2.5 or \> 2.5) at screening.||||||0.301
72468147|NCT01657799|144459150|SUPERIORITY||Hazard Ratio (HR)|1.047||||0.86|TWO_SIDED|95.0|0.626|1.754|||Cox proportional hazard model|Cox proportional hazard model stratified by GPA score (≤ 2.5 or \> 2.5) at screening.||||1.754|0.626|0.860
72504125|NCT01025336|144539190|SUPERIORITY_OR_OTHER||geometric mean fold rise|20.8|||||TWO_SIDED|95.0|12.59|34.24|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 6B: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||34.24|12.59|
72504126|NCT01025336|144539190|SUPERIORITY_OR_OTHER||geometric mean fold rise|21.4|||||TWO_SIDED|95.0|14.56|31.46|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 6B: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||31.46|14.56|
72468148|NCT01657799|144459150|SUPERIORITY||Hazard Ratio (HR)|1.295||||0.289|TWO_SIDED|95.0|0.803|2.086|||Cox proportional hazard model|Cox proportional hazard model stratified by GPA score (≤ 2.5 or \> 2.5) at screening.||||2.086|0.803|0.289
72468149|NCT03539068|144459165|SUPERIORITY||||||<|1e-05|||||||Chi-squared|||||||<0.00001
72468150|NCT04599855|144459170|SUPERIORITY||least square (LS) means difference|-5.1|STANDARD_ERROR_OF_MEAN|1.42|<|0.001|TWO_SIDED|95.0|-7.91|-2.33|||Mixed model for repeated measures|||||-2.33|-7.91|<0.001
72468151|NCT04599855|144459170|SUPERIORITY||LS means difference|-6.8|STANDARD_ERROR_OF_MEAN|1.38|<|0.001|TWO_SIDED|95.0|-9.48|-4.07|||Mixed model for repeated measures|||||-4.07|-9.48|<0.001
72468152|NCT04599855|144459171|SUPERIORITY||LS means difference|-3.8|STANDARD_ERROR_OF_MEAN|1.29|=|0.004|TWO_SIDED|95.0|-6.29|-1.22|||Mixed model for repeated measures|||||-1.22|-6.29|=0.004
72468153|NCT04599855|144459171|SUPERIORITY||LS means difference|-3.4|STANDARD_ERROR_OF_MEAN|1.24|=|0.006|TWO_SIDED|95.0|-5.89|-1.0|||Mixed model for repeated measures|||||-1.00|-5.89|=0.006
72468154|NCT02165397|144459172|SUPERIORITY||Hazard Ratio (HR)|0.25|||<|0.0001|TWO_SIDED|95.0|0.148|0.42||The treatment effect was tested with a stratified log rank test.|Log Rank||The hazard ratio and its 95% confidence interval were based on a Cox regression model stratified by the randomization stratification factors.|||0.420|0.148|< 0.0001
72468155|NCT02165397|144459173|SUPERIORITY||Rate Ratio|2.526|||<|0.0001|TWO_SIDED|95.0|1.753|3.639||Response rate was compared using Cochran-Mantel-Haenszel (CMH) chi-square test.|Cochran-Mantel-Haenszel|||||3.639|1.753|< 0.0001
72468156|NCT02165397|144459174|SUPERIORITY||Hazard Ratio (HR)|0.102|||<|0.0001|TWO_SIDED|95.0|0.049|0.212||P-value is from a stratified log-rank test.|Log Rank||Hazard ratio is estimated using a stratified Cox regression model.|||0.212|0.049|< 0.0001
72468157|NCT02165397|144459175|SUPERIORITY||Rate Ratio|1.813|||<|0.0001|TWO_SIDED|95.0|1.357|2.421|||Chi-squared|||||2.421|1.357|< 0.0001
72468158|NCT02165397|144459176|SUPERIORITY||Rate Ratio|1.238||||0.1059|TWO_SIDED|95.0|0.955|1.603||CMH chi squared test|Cochran-Mantel-Haenszel|||||1.603|0.955|0.1059
72504127|NCT01025336|144539190|SUPERIORITY_OR_OTHER||geometric mean fold rise|11.1|||||TWO_SIDED|95.0|7.24|17.01|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 6B: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||17.01|7.24|
72504128|NCT01025336|144539190|SUPERIORITY_OR_OTHER||geometric mean fold rise|32.2|||||TWO_SIDED|95.0|19.75|52.57|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 7F: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||52.57|19.75|
72394639|NCT02310568|144295797|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|1.23||0.848|TWO_SIDED|90.0|-2.3|1.8|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - Placebo). Week 4: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||1.8|-2.3|0.848
72394640|NCT02310568|144295797|SUPERIORITY_OR_OTHER||LS Mean Difference|1.5|STANDARD_ERROR_OF_MEAN|1.24||0.237|TWO_SIDED|90.0|-0.6|3.5|||Mixed-Effects Model Repeated Measure|||(PF-06372865 2.5 mg - Placebo). Week 4: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||3.5|-0.6|0.237
72394641|NCT02310568|144295797|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.7|STANDARD_ERROR_OF_MEAN|1.4||0.224|TWO_SIDED|90.0|-4.0|0.6|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 4: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||0.6|-4.0|0.224
72394642|NCT02310568|144295797|SUPERIORITY_OR_OTHER||LS Mean Difference|0.4|STANDARD_ERROR_OF_MEAN|1.38||0.747|TWO_SIDED|90.0|-1.9|2.8|||LS Mean Difference|||(PF-06372865 7.5 mg - Placebo). Week 5: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||2.8|-1.9|0.747
72394643|NCT02310568|144295797|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|1.37||0.764|TWO_SIDED|90.0|-2.8|2.0|||Mixed-Effects Model Repeated Measure|||(PF-06372865 2.5 mg - Placebo). Week 5: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28). Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||2.0|-2.8|0.764
72394644|NCT02310568|144295797|SUPERIORITY_OR_OTHER||LS Mean Difference|0.9|STANDARD_ERROR_OF_MEAN|1.22||0.487|TWO_SIDED|90.0|-1.3|3.0|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 5: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||3.0|-1.3|0.487
72394645|NCT02310568|144295797|SUPERIORITY_OR_OTHER||LS Mean Difference|0.5|STANDARD_ERROR_OF_MEAN|1.53||0.744|TWO_SIDED|90.0|-2.1|3.2|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - Placebo). Week 6: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||3.2|-2.1|0.744
72394646|NCT02310568|144295797|SUPERIORITY_OR_OTHER||LS Mean Difference|1.5|STANDARD_ERROR_OF_MEAN|1.52||0.34|TWO_SIDED|90.0|-1.1|4.1|||Mixed-Effects Model Repeated Measure|||(PF-06372865 2.5 mg - Placebo). Week 6: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||4.1|-1.1|0.340
72394647|NCT02310568|144295797|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|1.36||0.477|TWO_SIDED|90.0|-3.3|1.4|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 6: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||1.4|-3.3|0.477
72564949|NCT00418522|144661421|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|28.57|||<|0.0001||95.0|16.55|40.59|||ANCOVA|||Time 30 at Week 26.||40.59|16.55|<0.0001
72394648|NCT02310568|144295797|SUPERIORITY_OR_OTHER||LS Mean Difference|1.1|STANDARD_ERROR_OF_MEAN|1.51||0.482|TWO_SIDED|90.0|-1.5|3.7|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - Placebo). Week 7: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||3.7|-1.5|0.482
72394649|NCT02310568|144295797|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|1.49||0.719|TWO_SIDED|90.0|-3.1|2.0|||Mixed-Effects Model Repeated Measure|||(PF-06372865 2.5 mg - Placebo). Week 7: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||2.0|-3.1|0.719
72394650|NCT02310568|144295797|SUPERIORITY_OR_OTHER||LS Mean Difference|1.6|STANDARD_ERROR_OF_MEAN|1.36||0.245|TWO_SIDED|90.0|-0.7|4.0|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 7: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||4.0|-0.7|0.245
72394651|NCT02310568|144295797|SUPERIORITY_OR_OTHER||LS Mean Difference|1.1|STANDARD_ERROR_OF_MEAN|1.93||0.586|TWO_SIDED|90.0|-2.3|4.4|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - Placebo). Week 8: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||4.4|-2.3|0.586
72394652|NCT02310568|144295797|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.5|STANDARD_ERROR_OF_MEAN|1.9||0.44|TWO_SIDED|90.0|-4.8|1.8|||Mixed-Effects Model Repeated Measure|||(PF-06372865 2.5 mg - Placebo). Week 8: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||1.8|-4.8|0.440
72564950|NCT00418522|144661421|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|18.96||||0.0044||95.0|5.96|31.96|||ANCOVA|||Time 60 at Week 26.||31.96|5.96|0.0044
72564951|NCT00418522|144661421|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.69||||0.3168||95.0|-6.45|19.83|||ANCOVA|||Time 90 at Week 26.||19.83|-6.45|0.3168
72564952|NCT00418522|144661421|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.63||||0.9222||95.0|-12.12|13.39|||ANCOVA|||Time 120 at Week 26.||13.39|-12.12|0.9222
72564953|NCT00418522|144661421|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.41||||0.695||95.0|-14.51|9.69|||ANCOVA|||Time 180 at Week 26.||9.69|-14.51|0.6950
72468159|NCT02165397|144459177|SUPERIORITY||Hazard Ratio (HR)|0.808||||0.643|TWO_SIDED|95.0|0.328|1.99||P-value is from unstratified log rank test.|Log Rank||Hazard ratio is estimated using unstratified Cox regression model with treatment as the only covariate.|Data cutoff 18 December 2019||1.99|0.328|0.643
72468160|NCT00424554|144459185|SUPERIORITY_OR_OTHER|||||||0.09||95.0|||||t-test, 2 sided|||||||0.09
72468161|NCT00236184|144459194|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared, Corrected|||||||<0.001
72468162|NCT02312206|144459195|SUPERIORITY||Hazard Ratio (HR)|0.826||||0.3028|TWO_SIDED|95.0|0.5735|1.1889|||Log Rank|||||1.1889|0.5735|0.3028
72468163|NCT01772563|144459211|OTHER||Geometric mean ratio (GMR) [%]|93.63|||||TWO_SIDED|90.0|82.07|106.81|||||GMR (test/reference) i.e. (Volasertib+Itraconazole/ Volasertib). Intra- individual coefficient of variation (gCV%)=25.1.|"Statistical analysis of Volasertib:~AUC0-tz was log-transformed prior to fitting an analysis of variance (ANOVA) model. This model included effects for 'treatment' and 'subject'. 90% confidence intervals (CIs) were computed, then back-transformed to the original scale to give the point estimator and interval estimates for the geometric mean ratio (GMR)."||106.81|82.07|
72468164|NCT01772563|144459211|OTHER||Geometric mean ratio (GMR) [%]|75.77|||||TWO_SIDED|90.0|67.83|84.632|||||GMR (test/reference) i.e. (Volasertib+Itraconazole/ Volasertib). Intra- individual coefficient of variation (gCV %)=21.0.|"Statistical analysis of CD 10899:~AUC0-tz was log-transformed prior to fitting an analysis of variance (ANOVA) model. This model included effects for 'treatment' and 'subject'. 90% confidence intervals (CIs) were computed, then back-transformed to the original scale to give the point estimator and interval estimates for the geometric mean ratio (GMR)."||84.632|67.830|
72468165|NCT01772563|144459212|OTHER||Geometric mean ratio (GMR) [%]|79.4|||||TWO_SIDED|90.0|64.896|97.137|||||GMR (test/reference) i.e. (Volasertib+Itraconazole/ Volasertib). Intra- individual coefficient of variation (gCV %)=39.3.|"Statistical analysis of volasertib:~Cmax was log-transformed prior to fitting an analysis of variance (ANOVA) model. This model included effects for 'treatment' and 'subject'. 90% confidence intervals (CIs) were computed, then back-transformed to the original scale to give the point estimator and interval estimates for the geometric mean ratio (GMR)."||97.137|64.896|
72468166|NCT01772563|144459212|OTHER||Geometric mean ratio (GMR) [%]|63.48|||||TWO_SIDED|90.0|55.372|72.775|||||GMR (test/reference) i.e. (Volasertib+Itraconazole/ Volasertib). Intra- individual coefficient of variation (gCV%)=26.1.|"Statistical analysis of CD 10899:~Cmax was log-transformed prior to fitting an analysis of variance (ANOVA) model. This model included effects for 'treatment' and 'subject'. 90% confidence intervals (CIs) were computed, then back-transformed to the original scale to give the point estimator and interval estimates for the geometric mean ratio (GMR)."||72.775|55.372|
72468167|NCT01772563|144459213|OTHER||Geometric mean ratio (GMR) [%]|97.85|||||TWO_SIDED|90.0|87.09|109.94|||||GMR (test/reference) i.e. (Volasertib+Itraconazole/ Volasertib). Intra- individual coefficient of variation (gCV %)=22.7.|"Statistical analysis of volasertib:~AUC0-∞ was log-transformed prior to fitting an analysis of variance (ANOVA) model. This model included effects for 'treatment' and 'subject'. 90% confidence intervals (CIs) were computed, then back-transformed to the original scale to give the point estimator and interval estimates for the geometric mean ratio (GMR)."||109.94|87.09|
72468168|NCT01772563|144459213|OTHER||Geometric mean ratio (GMR) [%]|77.42|||||TWO_SIDED|90.0|69.001|86.871|||||GMR (test/reference) i.e. (Volasertib+Itraconazole/ Volasertib). Intra- individual coefficient of variation (gCV %)=22.5.|"Statistical analysis of CD 10899:~AUC0-∞ was log-transformed prior to fitting an analysis of variance (ANOVA) model. This model included effects for 'treatment' and 'subject'. 90% confidence intervals (CIs) were computed, then back-transformed to the original scale to give the point estimator and interval estimates for the geometric mean ratio (GMR)."||86.871|69.001|
72504129|NCT01025336|144539190|SUPERIORITY_OR_OTHER||geometric mean fold rise|47.2|||||TWO_SIDED|95.0|34.0|65.43|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 7F: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||65.43|34.00|
72468169|NCT00736125|144459217|EQUIVALENCE|nonparametric data were analyzed using Mann Whitney U Tests|||||>|0.05|||||||t-test, 2 sided|||||||>0.05
72468170|NCT00736125|144459218|SUPERIORITY||||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||||||>0.05
72564954|NCT00418522|144661422|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.61||||0.1207||95.0|-21.76|2.54|||ANCOVA|||Post-Breakfast, Week 26.||2.54|-21.76|0.1207
72564955|NCT00418522|144661422|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-29.11|||<|0.0001||95.0|-39.77|-18.44|||ANCOVA|||Post-Lunch, Week 26.||-18.44|-39.77|<0.0001
72468171|NCT01196819|144459223|NON_INFERIORITY|Non-inferiority margin is 0.13mm, if the two-sided upper 95% confidence bound is \<Δ, the Firehawk Stent being tested will be considered non-inferior to the control. This corresponds to a P value \<0.05 from a two-sided Student t-test comparing the difference between FirehawkStent and Xience stent to delta.|Mean Difference (Final Values)|0.17||||0.94|TWO_SIDED|95.0|0.0|0.29|||ANCOVA|||H0: Pe - Pc≥ ∆, H1: Pe - Pc \< ∆. Pe and Pc are the mean 9-month in-stent late loss for the subject in the Firehawk DES group and the Xience group, respectively. ∆ is the non-inferiority margin. A two-sided upper 95% confidence bound will be calculated for the difference in 9-month in-stent late loss .||0.29|0|0.94
72468172|NCT01196819|144459224|NON_INFERIORITY|Assume the in-stent percent diameter stenosis of both FIREHAWK and XIENCE V are 16 ± 16%, the non-inferiority value is 5%, the level of statistical significance is 0.05 (bilateral test), the power is 85%.||||||0.69|||||||Mixed Models Analysis|||||||0.69
72468173|NCT01196819|144459225|OTHER|||||||1|||||||Fisher Exact|||||||1.0
72468174|NCT01196819|144459226|OTHER|||||||0.76|||||||Fisher Exact|||||||0.76
72564956|NCT00418522|144661422|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-33.76|||<|0.0001||95.0|-44.17|-23.35|||ANCOVA|||Post-Dinner, Week 26.||-23.35|-44.17|<0.0001
72564957|NCT00418522|144661423|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.21||||0.0735||95.0|-0.5|10.91|||ANCOVA|||Total Cholesterol at Week 26.||10.91|-0.50|0.0735
72621903|NCT01946880|144774210|OTHER|The estimated risk difference (i.e. risk(MMF Withdrawal) - risk(MMF Maintenance)) and 95% confidence intervals around the risk difference at Week 60 were reported using the Kaplan-Meier product-limit estimator.|Risk Difference (RD)|0.06|||||TWO_SIDED|95.0|-0.02|0.134||||||||0.134|-0.020|
72564958|NCT00418522|144661423|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.09||||0.0017||95.0|0.79|3.39|||ANCOVA|||HDL-c at Week 26.||3.39|0.79|0.0017
72394653|NCT02310568|144295797|SUPERIORITY_OR_OTHER||LS Mean Difference|2.6|STANDARD_ERROR_OF_MEAN|1.75||0.159|TWO_SIDED|90.0|-0.5|5.6|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 8: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||5.6|-0.5|0.159
72394654|NCT02310568|144295797|SUPERIORITY_OR_OTHER||LS Mean Difference|0.4|STANDARD_ERROR_OF_MEAN|1.15||0.72|TWO_SIDED|90.0|-1.6|2.4|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - Placebo). Combined Stage 1 and Stage 2: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect.||2.4|-1.6|0.720
72468175|NCT01196819|144459227|OTHER|||||||0.77|||||||Fisher Exact|||||||0.77
72468176|NCT01196819|144459228|OTHER|||||||1|||||||Fisher Exact|||||||1.0
72468177|NCT01086384|144459231|SUPERIORITY_OR_OTHER||Regression Cox|0.795|||||TWO_SIDED|95.0|0.642|0.985|||||The estimated values is the Hazard ratio obtained from the Cox regression analysis for FF/VI 100/25 µg versus FF 100 µg, adjusted for an interim analysis.|||0.985|0.642|
72468178|NCT01086384|144459231|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|15.9||||0.036|TWO_SIDED|95.0|13.5|18.2||P-value for the Hazard ratio obtained from the Cox regression analysis for FF/VI 100/25 µg versus FF 100 µg, adjusted for an interim analysis.|Regression, Cox||The estimated value represents the adjusted probability of 1 or more severe asthma exacerbations by Week 52 for FF 100 µg. Cox Proportional Hazards Model estimate at mean Baseline FEV1, age, and proportional coefficients for sex and region.|||18.2|13.5|0.036
72468179|NCT01086384|144459231|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|12.8||||0.036|TWO_SIDED|95.0|10.7|14.9||P-value for the Hazard ratio obtained from the Cox regression analysis for FF/VI 100/25 µg versus FF 100 µg, adjusted for an interim analysis.|Regression, Cox||The estimated value represents the adjusted probability of 1 or more severe asthma exacerbations by Week 52 for FF/VI 100/25 µg. Cox Proportional Hazards Model estimate at mean Baseline FEV1, age, and proportional coefficients for sex and region.|||14.9|10.7|0.036
72468180|NCT03732820|144459241|SUPERIORITY||Hazard Ratio (HR)|0.66|||<|0.0001|TWO_SIDED|95.0|0.54|0.81||A multiple testing procedure is employed across primary (rPFS) and key secondary endpoints (OS) to strongly control overall type 1 error at 2.5% one-sided.|Log Rank|Log rank test stratified by Metastases and Docetaxel at metastatic hormone-sensitive prostate cancer stage using a pre-specified pooling strategy.|HR and CI calculated using Cox Proportional Hazards model, where a HR \< 1 favours olaparib+abiraterone. Stratification factors are the same as those used in the stratified log-rank test.|||0.81|0.54|<0.0001
72468181|NCT03732820|144459242|SUPERIORITY||Hazard Ratio (HR)|0.81||||0.0544|TWO_SIDED|95.0|0.67|1.0||A multiple testing procedure is employed across primary (rPFS) and key secondary endpoints (OS) to strongly control overall type 1 error at 2.5% one-sided. Alpha spend for OS will not exceed 0.02135.|Log Rank|Log rank test stratified by Metastases and Docetaxel at metastatic hormone-sensitive prostate cancer stage using a pre-specified pooling strategy.|HR and CI calculated using Cox Proportional Hazards model, where a HR \< 1 favours olaparib+abiraterone. Stratification factors are the same as those used in the stratified log-rank test.|||1.00|0.67|0.0544
72504130|NCT01025336|144539190|SUPERIORITY_OR_OTHER||geometric mean fold rise|19.4|||||TWO_SIDED|95.0|12.95|29.17|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 7F: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||29.17|12.95|
72564959|NCT00418522|144661423|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.43||||0.1369||95.0|-1.1|7.96|||ANCOVA|||LDL-c at Week 26.||7.96|-1.10|0.1369
72394655|NCT02310568|144295797|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|1.13||0.991|TWO_SIDED|90.0|-2.0|1.9|||Mixed-Effects Model Repeated Measure|||(PF-06372865 2.5 mg - Placebo). Combined Stage 1 and Stage 2: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect.||1.9|-2.0|0.991
72468182|NCT03732820|144459243|SUPERIORITY||Hazard Ratio (HR)|0.76||||0.0025|TWO_SIDED|95.0|0.64|0.9|||Log Rank|Log rank test stratified by Metastases and Docetaxel at metastatic hormone-sensitive prostate cancer stage using a pre-specified pooling strategy.|HR and CI calculated using Cox Proportional Hazards model, where a HR \< 1 favours olaparib+abiraterone. Stratification factors are the same as those used in the stratified log-rank test.|||0.90|0.64|0.0025
72468183|NCT03732820|144459244|SUPERIORITY||Hazard Ratio (HR)|1.06||||0.7456|TWO_SIDED|95.0|0.75|1.5|||Log Rank|Log rank test stratified by Metastases and Docetaxel at metastatic hormone-sensitive prostate cancer stage using a pre-specified pooling strategy.|HR and CI calculated using Cox Proportional Hazards model, where a HR \< 1 favours olaparib+abiraterone. Stratification factors are the same as those used in the stratified log-rank test.|||1.50|0.75|0.7456
72468184|NCT03732820|144459245|SUPERIORITY||Hazard Ratio (HR)|1.21||||0.3099|TWO_SIDED|95.0|0.82|1.79|||Log Rank|Log rank test stratified by Metastases and Docetaxel at metastatic hormone-sensitive prostate cancer stage using a pre-specified pooling strategy.|HR and CI calculated using Cox Proportional Hazards model, where a HR \< 1 favours olaparib+abiraterone. Stratification factors are the same as those used in the stratified log-rank test.|||1.79|0.82|0.3099
72504131|NCT01025336|144539190|SUPERIORITY_OR_OTHER||geometric mean fold rise|12.8|||||TWO_SIDED|95.0|7.79|21.13|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 9V: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||21.13|7.79|
72564960|NCT00418522|144661423|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.26||||0.5684||95.0|-10.4|18.92|||ANCOVA|||Triglycerides at Week 26.||18.92|-10.40|0.5684
72564961|NCT00418522|144661424|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.24||||0.5673||95.0|-0.58|1.06|||ANCOVA|||hs-CRP at Week 26.||1.06|-0.58|0.5673
72564962|NCT00418522|144661424|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.61||||0.6099||95.0|-2.97|1.75|||ANCOVA|||Leptin at Week 26.||1.75|-2.97|0.6099
72564963|NCT00418522|144661424|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.28||||0.7684||95.0|-12.94|17.51|||ANCOVA|||Spot urine microalbumin at Week 26.||17.51|-12.94|0.7684
72564964|NCT00418522|144661425|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.36||||0.5005||95.0|-0.69|1.42|||ANCOVA|||Adiponectin at Week 26.||1.42|-0.69|0.5005
72564965|NCT00418522|144661425|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01||||0.685||95.0|-0.03|0.04|||ANCOVA|||ApoB at Week 26.||0.04|-0.03|0.6850
72394656|NCT02310568|144295797|SUPERIORITY_OR_OTHER||LS Mean Difference|0.4|STANDARD_ERROR_OF_MEAN|1.12||0.704|TWO_SIDED|90.0|-1.5|2.4|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Combined Stage 1 and Stage 2: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect.||2.4|-1.5|0.704
72468185|NCT03732820|144459246|SUPERIORITY||Hazard Ratio (HR)|0.82||||0.3212|TWO_SIDED|95.0|0.55|1.22|||Log Rank|Log rank test stratified by Metastases and Docetaxel at metastatic hormone-sensitive prostate cancer stage using a pre-specified pooling strategy.|HR and CI calculated using Cox Proportional Hazards model, where a HR \< 1 favours olaparib+abiraterone. Stratification factors are the same as those used in the stratified log-rank test.|||1.22|0.55|0.3212
72468186|NCT03732820|144459247|SUPERIORITY||Hazard Ratio (HR)|0.76||||0.0534|TWO_SIDED|95.0|0.59|0.99|||Log Rank|Log rank test stratified by Metastases and Docetaxel at metastatic hormone-sensitive prostate cancer stage using a pre-specified pooling strategy.|HR and CI calculated using Cox Proportional Hazards model, where a HR \< 1 favours olaparib+abiraterone. Stratification factors are the same as those used in the stratified log-rank test.|||0.99|0.59|0.0534
72468187|NCT00992992|144459250|SUPERIORITY_OR_OTHER_LEGACY||Percentage of participants|56.0|||||TWO_SIDED|95.0|37.0|75.0|||||The estimated value reflects the percentage of participants with unconfirmed complete response (CR).|||75|37|
72468188|NCT00992992|144459250|SUPERIORITY_OR_OTHER_LEGACY||Percentage of participants|8.0|||||TWO_SIDED|95.0|0.0|19.0|||||The estimated value reflects the percentage of participants with unconfirmed complete response unconfirmed (CRu).|||19|0|
72468189|NCT00992992|144459250|SUPERIORITY_OR_OTHER_LEGACY||Percentage of participants|20.0|||||TWO_SIDED|95.0|4.0|36.0|||||The estimated value reflects the percentage of participants with unconfirmed partial response.|||36|4|
72468190|NCT03856047|144459282|SUPERIORITY||Treatment difference (%-points)|-2.99|STANDARD_ERROR_OF_MEAN|0.81||0.0002|TWO_SIDED|95.0|-4.58|-1.4|||ANCOVA|||Week 26 responses were analysed using an analysis of covariance (ANCOVA) model with randomised treatment as factor and baseline (week 0) body weight as covariate. For each treatment arm, multiple (x1000) imputation of intermittend missing data was done using Markov Chain Monte Carlo, followed by sequential regression for monotone missing values of body weight including sex and region as factors.||-1.40|-4.58|0.0002
72504132|NCT01025336|144539190|SUPERIORITY_OR_OTHER||geometric mean fold rise|12.6|||||TWO_SIDED|95.0|8.56|18.68|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 9V: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||18.68|8.56|
72468191|NCT03856047|144459282|SUPERIORITY||Treatment difference (%-points)|-3.78|STANDARD_ERROR_OF_MEAN|0.82|<|0.0001|TWO_SIDED|95.0|-5.38|-2.17|||ANCOVA|||Week 26 responses were analysed using an analysis of covariance model with randomised treatment as factor and baseline (week 0) body weight as covariate. For each treatment arm, multiple (x1000) imputation of intermittend missing data was done using Markov Chain Monte Carlo, followed by sequential regression for monotone missing values of body weight including sex and region as factors.||-2.17|-5.38|<.0001
72468192|NCT03856047|144459282|SUPERIORITY||Treatment difference (%-points)|-6.07|STANDARD_ERROR_OF_MEAN|0.87|<|0.0001|TWO_SIDED|95.0|-7.77|-4.36|||ANCOVA|||Week 26 responses were analysed using an analysis of covariance model with randomised treatment as factor and baseline (week 0) body weight as covariate. For each treatment arm, multiple (x1000) imputation of intermittend missing data was done using Markov Chain Monte Carlo, followed by sequential regression for monotone missing values of body weight including sex and region as factors.||-4.36|-7.77|<.0001
72468193|NCT03856047|144459282|SUPERIORITY||Treatment difference (%-points)|-6.68|STANDARD_ERROR_OF_MEAN|0.81|<|0.0001|TWO_SIDED|95.0|-8.28|-5.09|||ANCOVA|||Week 26 responses were analysed using an analysis of covariance model with randomised treatment as factor and baseline (week 0) body weight as covariate. For each treatment arm, multiple (x1000) imputation of intermittend missing data was done using Markov Chain Monte Carlo, followed by sequential regression for monotone missing values of body weight including sex and region as factors.||-5.09|-8.28|<.0001
72468194|NCT03856047|144459282|SUPERIORITY||Treatment difference (%-points)|-7.79|STANDARD_ERROR_OF_MEAN|0.83|<|0.0001|TWO_SIDED|95.0|-9.42|-6.16|||ANCOVA|||Week 26 responses were analysed using an analysis of covariance model with randomised treatment as factor and baseline (week 0) body weight as covariate. For each treatment arm, multiple (x1000) imputation of intermittend missing data was done using Markov Chain Monte Carlo, followed by sequential regression for monotone missing values of body weight including sex and region as factors.||-6.16|-9.42|<.0001
72468195|NCT03856047|144459282|SUPERIORITY||Treatment difference (%-points)|-5.98|STANDARD_ERROR_OF_MEAN|0.83|<|0.0001|TWO_SIDED|95.0|-7.61|-4.35|||ANCOVA|||Week 26 responses were analysed using an analysis of covariance model with randomised treatment as factor and baseline (week 0) body weight as covariate. For each treatment arm, multiple (x1000) imputation of intermittend missing data was done using Markov Chain Monte Carlo, followed by sequential regression for monotone missing values of body weight including sex and region as factors.||-4.35|-7.61|<.0001
72504133|NCT01025336|144539190|SUPERIORITY_OR_OTHER||geometric mean fold rise|6.8|||||TWO_SIDED|95.0|4.54|10.1|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 9V: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||10.10|4.54|
72504134|NCT01025336|144539190|SUPERIORITY_OR_OTHER||geometric mean fold rise|12.8|||||TWO_SIDED|95.0|8.16|20.02|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 14: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||20.02|8.16|
72564966|NCT00418522|144661426|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|58.7||||0.1856||95.0|-43.37|160.77|||ANCOVA|||||160.77|-43.37|0.1856
72564967|NCT00418522|144661427|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-18.72||||0.1862||95.0|-51.34|13.89|||ANCOVA|||||13.89|-51.34|0.1862
72564968|NCT00418522|144661433|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.2||||0.0055||95.0|0.35|2.04|||ANCOVA|||||2.04|0.35|0.0055
72564969|NCT00418522|144661434|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.42||||0.0053||95.0|0.12|0.71|||ANCOVA|||||0.71|0.12|0.0053
72621904|NCT01946880|144774211|OTHER||Mean Difference (Final Values)|0.0|||||TWO_SIDED|95.0|-0.1|0.1|||||Estimate is for the difference in the change from baseline for MMF Withdrawal - MMF Maintenance at Week 24.|Descriptive statistics (mean and 95% confidence interval) are reported for the difference in the change from baseline in the SLICC/DI score between the treatment groups at Week 24.||0.1|-0.1|
72504135|NCT01025336|144539190|SUPERIORITY_OR_OTHER||geometric mean fold rise|11.5|||||TWO_SIDED|95.0|8.15|16.23|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 14: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||16.23|8.15|
72504136|NCT01025336|144539190|SUPERIORITY_OR_OTHER||geometric mean fold rise|8.0|||||TWO_SIDED|95.0|5.75|11.25|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 14: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||11.25|5.75|
72504137|NCT01025336|144539190|SUPERIORITY_OR_OTHER||geometric mean fold rise|20.0|||||TWO_SIDED|95.0|12.99|30.76|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 18C: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||30.76|12.99|
72621905|NCT01946880|144774211|OTHER||Mean Difference (Final Values)|0.0|||||TWO_SIDED|95.0|-0.1|0.1|||||Estimate is for the difference in the change from baseline for MMF Withdrawal - MMF Maintenance at Week 48.|Descriptive statistics (mean and 95% confidence interval) are reported for the difference in the change from baseline in the SLICC/DI score between the treatment groups at Week 48.||0.1|-0.1|
72621906|NCT01946880|144774211|OTHER||Mean Difference (Final Values)|0.0|||||TWO_SIDED|95.0|-0.2|0.1|||||Estimate is for the difference in the change from baseline for MMF Withdrawal - MMF Maintenance at Week 60.|Descriptive statistics (mean and 95% confidence interval) are reported for the difference in the change from baseline in the SLICC/DI score between the treatment groups at Week 60.||0.1|-0.2|
72621907|NCT01946880|144774212|OTHER|The estimated risk difference (i.e. risk(MMF Withdrawal) - risk(MMF Maintenance)) and 95% confidence intervals around the risk difference at Week 60 were reported using the Kaplan-Meier product-limit estimator.|Risk Difference (RD)|0.02|||||TWO_SIDED|95.0|-0.019|0.059||||||||0.059|-0.019|
72621908|NCT01946880|144774214|OTHER||Mean Difference (Final Values)|1.61|||||TWO_SIDED|95.0|-2.24|5.45|||||Estimate is for the difference in the change from baseline for MMF Withdrawal - MMF Maintenance at Week 24.|Descriptive statistics (mean and 95% confidence interval) are reported for the difference in the change from baseline in the FACIT fatigue score between the treatment groups at Week 24.||5.45|-2.24|
72504138|NCT01025336|144539190|SUPERIORITY_OR_OTHER||geometric mean fold rise|22.3|||||TWO_SIDED|95.0|16.5|30.06|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 18C: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||30.06|16.50|
72621909|NCT01946880|144774214|OTHER||Mean Difference (Final Values)|2.54|||||TWO_SIDED|95.0|-1.13|6.21|||||Estimate is for the difference in the change from baseline for MMF Withdrawal - MMF Maintenance at Week 48.|Descriptive statistics (mean and 95% confidence interval) are reported for the difference in the change from baseline in the FACIT fatigue score between the treatment groups at Week 48.||6.21|-1.13|
72621910|NCT01946880|144774214|OTHER||Mean Difference (Final Values)|3.55|||||TWO_SIDED|95.0|-0.17|7.28|||||Estimate is for the difference in the change from baseline for MMF Withdrawal - MMF Maintenance at Week 60.|Descriptive statistics (mean and 95% confidence interval) are reported for the difference in the change from baseline in the FACIT fatigue score between the treatment groups at Week 60.||7.28|-0.17|
72504139|NCT01025336|144539190|SUPERIORITY_OR_OTHER||geometric mean fold rise|9.8|||||TWO_SIDED|95.0|7.07|13.63|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 18C: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||13.63|7.07|
72504140|NCT01025336|144539190|SUPERIORITY_OR_OTHER||geometric mean fold rise|12.0|||||TWO_SIDED|95.0|8.82|16.34|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 19A: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||16.34|8.82|
72504141|NCT01025336|144539190|SUPERIORITY_OR_OTHER||geometric mean fold rise|13.0|||||TWO_SIDED|95.0|10.21|16.66|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 19A: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||16.66|10.21|
72504142|NCT01025336|144539190|SUPERIORITY_OR_OTHER||geometric mean fold rise|7.6|||||TWO_SIDED|95.0|5.86|9.94|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 19A: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||9.94|5.86|
72564970|NCT00418522|144661436|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority test utilized a one-sided 2.5% level of significance.|Mean Difference (Final Values)|-0.27|||<|0.0001||95.0|-0.47|-0.08|||ANCOVA||A CI approach was presented with a two-sided 95% CI of the difference between treatment and control.|The null hypothesis was that the inhaled human insulin group was inferior to the insulin glargine group with respect to 26-week change from baseline in HbA1c, while the alternate hypothesis is that the inhaled human insulin group was not inferior to the insulin glargine group with respect to 26-week change from baseline in HbA1c, given the predetermined non-inferiority margin of 0.4%.||-0.08|-0.47|<0.0001
72468196|NCT03856047|144459282|SUPERIORITY||Treatment difference (%-points)|2.99|STANDARD_ERROR_OF_MEAN|0.82||0.0003|TWO_SIDED|95.0|1.38|4.6|||ANCOVA|||Week 26 responses were analysed using an analysis of covariance model with randomised treatment as factor and baseline (week 0) body weight as covariate. For each treatment arm, multiple (x1000) imputation of intermittend missing data was done using Markov Chain Monte Carlo, followed by sequential regression for monotone missing values of body weight including sex and region as factors.||4.60|1.38|0.0003
72468197|NCT03856047|144459282|SUPERIORITY||Treatment difference (%-points)|2.2|STANDARD_ERROR_OF_MEAN|0.83||0.0082|TWO_SIDED|95.0|0.57|3.84|||ANCOVA|||Week 26 responses were analysed using an analysis of covariance model with randomised treatment as factor and baseline (week 0) body weight as covariate. For each treatment arm, multiple (x1000) imputation of intermittend missing data was done using Markov Chain Monte Carlo, followed by sequential regression for monotone missing values of body weight including sex and region as factors.||3.84|0.57|0.0082
72468198|NCT03856047|144459282|SUPERIORITY||Treatment difference (%-points)|-0.09|STANDARD_ERROR_OF_MEAN|0.88||0.9209|TWO_SIDED|95.0|-1.82|1.64|||ANCOVA|||Week 26 responses were analysed using an analysis of covariance model with randomised treatment as factor and baseline (week 0) body weight as covariate. For each treatment arm, multiple (x1000) imputation of intermittend missing data was done using Markov Chain Monte Carlo, followed by sequential regression for monotone missing values of body weight including sex and region as factors.||1.64|-1.82|0.9209
72468199|NCT03856047|144459282|SUPERIORITY||Treatment difference (%-points)|-0.7|STANDARD_ERROR_OF_MEAN|0.83||0.396|TWO_SIDED|95.0|-2.33|0.92|||ANCOVA|||Week 26 responses were analysed using an analysis of covariance model with randomised treatment as factor and baseline (week 0) body weight as covariate. For each treatment arm, multiple (x1000) imputation of intermittend missing data was done using Markov Chain Monte Carlo, followed by sequential regression for monotone missing values of body weight including sex and region as factors.||0.92|-2.33|0.3960
72468200|NCT03856047|144459282|SUPERIORITY||Treatment difference (%-points)|-1.81|STANDARD_ERROR_OF_MEAN|0.84||0.0316|TWO_SIDED|95.0|-3.46|-0.16|||ANCOVA|||Week 26 responses were analysed using an analysis of covariance model with randomised treatment as factor and baseline (week 0) body weight as covariate. For each treatment arm, multiple (x1000) imputation of intermittend missing data was done using Markov Chain Monte Carlo, followed by sequential regression for monotone missing values of body weight including sex and region as factors.||-0.16|-3.46|0.0316
72468201|NCT00874497|144459315|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0824||||0.1761|TWO_SIDED|95.0|-0.0378|0.2025||P-values are based on Analysis of Covariance (ANCOVA) model of the change FEV1 from baseline to the specified study week using treatment group and current smoking status as fixed effects and the baseline FEV1 value as a covariate.|ANCOVA|||Statistical analysis at Week 104.||0.2025|-0.0378|0.1761
72468202|NCT00874497|144459316|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.904||||0.139|TWO_SIDED|95.0|-6.77|0.97|||ANCOVA|||Statistical analysis of Right Upper region of the lung at Week 104.||0.97|-6.77|0.139
72468203|NCT00874497|144459316|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.21||||0.46|TWO_SIDED|95.0|-4.46|2.04|||ANCOVA|||Statistical analysis of Right Middle region of the Lung at Week 104.||2.04|-4.46|0.460
72468204|NCT00874497|144459316|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.176||||0.457|TWO_SIDED|95.0|-7.98|3.63|||ANCOVA|||Statistical analysis of Right Lower region of the Lung at Week 104.||3.63|-7.98|0.457
72468205|NCT00874497|144459316|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.167||||0.362|TWO_SIDED|95.0|-6.88|2.54|||ANCOVA|||Statistical analysis of Left Upper region of the Lung at Week 104.||2.54|-6.88|0.362
72468206|NCT00874497|144459316|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.225||||0.67|TWO_SIDED|95.0|-6.94|4.48|||ANCOVA|||Statistical analysis of Left Lower region of the Lung at Week 104.||4.48|-6.94|0.670
72468207|NCT00874497|144459316|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.218||||0.244|TWO_SIDED|95.0|-5.98|1.55|||ANCOVA|||Statistical analysis of Right Whole region of the Lung at Week 104.||1.55|-5.98|0.244
72621911|NCT01946880|144774215|OTHER||Mean Difference (Final Values)|0.55|||||TWO_SIDED|95.0|-1.82|2.92|||||Estimate is for the difference in the change from baseline for MMF Withdrawal - MMF Maintenance at Week 24.|Descriptive statistics (mean and 95% confidence interval) are reported for the difference in the change from baseline in the PF score between the treatment groups at Week 24.||2.92|-1.82|
72621912|NCT01946880|144774215|OTHER||Mean Difference (Final Values)|1.44|||||TWO_SIDED|95.0|-1.14|4.03|||||Estimate is for the difference in the change from baseline for MMF Withdrawal - MMF Maintenance at Week 48.|Descriptive statistics (mean and 95% confidence interval) are reported for the difference in the change from baseline in the PF score between the treatment groups at Week 48.||4.03|-1.14|
72621913|NCT01946880|144774215|OTHER||Mean Difference (Final Values)|1.98|||||TWO_SIDED|95.0|-0.71|4.67|||||Estimate is for the difference in the change from baseline for MMF Withdrawal - MMF Maintenance at Week 60.|Descriptive statistics (mean and 95% confidence interval) are reported for the difference in the change from baseline in the PF score between the treatment groups at Week 60.||4.67|-0.71|
72621914|NCT01946880|144774216|OTHER||Mean Difference (Final Values)|1.65|||||TWO_SIDED|95.0|-1.03|4.32|||||Estimate is for the difference in the change from baseline for MMF Withdrawal - MMF Maintenance at Week 24.|Descriptive statistics (mean and 95% confidence interval) are reported for the difference in the change from baseline in the PCS score between the treatment groups at Week 24.||4.32|-1.03|
72468208|NCT00874497|144459316|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.374||||0.574|TWO_SIDED|95.0|-6.23|3.48|||ANCOVA|||Statistical analysis of Left Whole region of the Lung at Week 104.||3.48|-6.23|0.574
72468209|NCT00874497|144459318|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.97||||0.436|TWO_SIDED|95.0|-1.53|3.47|||ANCOVA|||Statistical analysis of Right Upper region of the Lung at Week 104.||3.47|-1.53|0.436
72468210|NCT00874497|144459318|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.31||||0.067|TWO_SIDED|95.0|-0.17|4.79|||ANCOVA|||Statistical analysis of Right Middle region of the Lung at Week 104.||4.79|-0.17|0.067
72468211|NCT00874497|144459318|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.97||||0.163|TWO_SIDED|95.0|-0.83|4.77|||ANCOVA|||Statistical analysis of Right Lower region of the Lung at Week 104.||4.77|-0.83|0.163
72468212|NCT00874497|144459318|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.27||||0.102|TWO_SIDED|95.0|-0.48|5.02|||ANCOVA|||Statistical analysis of Left Upper region of the Lung at Week 104.||5.02|-0.48|0.102
72564971|NCT00418522|144661436|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.27||||0.0062||95.0|-0.47|-0.08|||ANCOVA||The superiority test used a one-sided 2.5% level of significance.|With an established non-inferiority claim, an additional test for superiority was conducted (ie, the margin was 0.0%).||-0.08|-0.47|0.0062
72564972|NCT02695719|144661437|SUPERIORITY||Median Values of CI|1.0||||0.007|TWO_SIDED|95.0|0.1|1.9||No adjustment was made as there was only one primary comparison.|Van Elteren Test|The Van Elteren test is a stratified version of the Wilcoxon-Mann-Whitney test which provides approximate sample size for the van Elteren analysis.|CI was estimated by inverting the hypothesis test.|Assuming equal allocation, a power of 90%, an alpha level of 0.05 for a 2-sided test, a placebo mean of 4 (standard deviation of 2.7), and a treatment mean of 5.9 (standard deviation of 4) for SBM frequency at Week 1 and using Wilcoxon-Mann-Whitney test, a total sample size of 146 is required. Analysis was conducted using van Elteren test.||1.9|0.1|0.007
72564973|NCT01005329|144661456|OTHER||||||||||||||||||The rate of the acute specified AEs (adverse events) from previous (and prior to ClinicalTrials.gov requirements) Radiation Therapy Oncology Group (RTOG) trial 9708 of RT + cisplatin was 44% and the hypothesis is that the addition of bevacizumab to IMRT + cisplatin will not increase this rate beyond 60%. This study was designed with a 1-sided, upper bound confidence interval to estimate this AE rate. Twenty-seven evaluable patients were required to have 95% confidence that the true grade 3+ non-hematologic treatment-related AE rate is not greater than 60%. Please note that this is a 95% ONE-SIDED confidence bound which is equivalent to the upper bound of a two-sided 90% confidence interval.|||
72564974|NCT02997657|144661463|SUPERIORITY|||||||0.71|||||||Chi-squared|||||||0.71
72564975|NCT02997657|144661464|SUPERIORITY|||||||0.81|||||||Chi-squared|||||||0.81
72564976|NCT02997657|144661465|SUPERIORITY|||||||0.69|||||||Chi-squared|||||||0.69
72564977|NCT02997657|144661466|SUPERIORITY|||||||0.96|||||||Chi-squared|||||||0.96
72394657|NCT02310568|144295798|SUPERIORITY_OR_OTHER||LS Mean Difference|0.5|STANDARD_ERROR_OF_MEAN|0.82||0.539|TWO_SIDED|90.0|-0.9|1.9|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - Placebo). Week 1: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||1.9|-0.9|0.539
72394658|NCT02310568|144295798|SUPERIORITY_OR_OTHER||LS Mean Difference|0.6|STANDARD_ERROR_OF_MEAN|0.78||0.439|TWO_SIDED|90.0|-0.7|1.9|||Mixed-Effects Model Repeated Measure|||(PF-06372865 2.5 mg - Placebo). Week 1: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||1.9|-0.7|0.439
72564978|NCT02997657|144661467|SUPERIORITY|||||||0.11|||||||t-test, 2 sided|||||||0.11
72564979|NCT02997657|144661468|SUPERIORITY|||||||0.9|||||||Chi-squared|||||||0.90
72468213|NCT00874497|144459318|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.11||||0.162|TWO_SIDED|95.0|-0.89|5.12|||ANCOVA|||Statistical analysis of Left Lower region of the Lung at Week 104.||5.12|-0.89|0.162
72564980|NCT02997657|144661469|SUPERIORITY|||||||0.82|||||||t-test, 2 sided|||||||0.82
72564981|NCT01272921|144661480|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.52|||<|0.001|TWO_SIDED|95.0|0.49|0.54|||Z score|||||0.54|0.49|<0.001
72564982|NCT01272921|144661480|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.19|||<|0.001|TWO_SIDED|95.0|0.18|0.21|||Z score|||||0.21|0.18|<0.001
72564983|NCT01272921|144661481|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.0|STANDARD_DEVIATION|0.0||0.05|TWO_SIDED|95.0|-17.0|-6.0||Post hoc comparison were made against the 30-mL volume group and corrected for 6 comparisons using the Wilcoxon rank sum test.|Wilcoxon (Mann-Whitney)|||The sample selected for this study,70 per drug group (or 10 in each of the 7 groups), achieves 88% power to detect a minimal difference of 4 hours in duration at a significance level (α) of 0.05 and a standard deviation of 3 hours using Williams test. We chose a difference of 4 hours as this was the interval used for assessment in the postoperative period at night. We sought to detect a difference that was equal to 1 observation period difference.||-6.00|-17.00|0.05
72564984|NCT01272921|144661481|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.0|STANDARD_DEVIATION|0.0||0.05|TWO_SIDED|95.0|-15.0|-6.0|||Wilcoxon (Mann-Whitney)|||The sample selected for this study,70 per drug group (or 10 in each of the 7 groups), achieves 88% power to detect a minimal difference of 4 hours in duration at a significance level (α) of 0.05 and a standard deviation of 3 hours using Williams test. We chose a difference of 4 hours as this was the interval used for assessment in the postoperative period at night. We sought to detect a difference that was equal to 1 observation period difference.||-6.00|-15.00|0.05
72564985|NCT01272921|144661481|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.0|STANDARD_DEVIATION|0.0||0.05|TWO_SIDED|95.0|-10.0|-4.0|||Wilcoxon (Mann-Whitney)|||The sample selected for this study,70 per drug group (or 10 in each of the 7 groups), achieves 88% power to detect a minimal difference of 4 hours in duration at a significance level (α) of 0.05 and a standard deviation of 3 hours using Williams test. We chose a difference of 4 hours as this was the interval used for assessment in the postoperative period at night. We sought to detect a difference that was equal to 1 observation period difference.||-4.00|-10.00|0.05
72621915|NCT01946880|144774216|OTHER||Mean Difference (Final Values)|2.17|||||TWO_SIDED|95.0|-0.69|5.02|||||Estimate is for the difference in the change from baseline for MMF Withdrawal - MMF Maintenance at Week 48.|Descriptive statistics (mean and 95% confidence interval) are reported for the difference in the change from baseline in the PCS score between the treatment groups at Week 48.||5.02|-0.69|
72394659|NCT02310568|144295798|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.92||0.914|TWO_SIDED|90.0|-1.6|1.4|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 1: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||1.4|-1.6|0.914
72468214|NCT00874497|144459318|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.78||||0.16|TWO_SIDED|95.0|-0.73|4.29|||ANCOVA|||Statistical analysis of Right Whole region of the Lung at Week 104.||4.29|-0.73|0.160
72468215|NCT00874497|144459318|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.08||||0.122|TWO_SIDED|95.0|-0.58|4.75|||ANCOVA|||Statistical analysis of Left Whole region of the Lung at Week 104.||4.75|-0.58|0.122
72468216|NCT00874497|144459318|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.05||||0.106|TWO_SIDED|95.0|-0.46|4.56|||ANCOVA|||Statistical analysis of Whole Lung region of the Lung at Week 104.||4.56|-0.46|0.106
72394660|NCT02310568|144295798|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.86||0.892|TWO_SIDED|90.0|-1.3|1.5|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - Placebo). Week 2: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||1.5|-1.3|0.892
72394661|NCT02310568|144295798|SUPERIORITY_OR_OTHER||LS Mean Difference|0.6|STANDARD_ERROR_OF_MEAN|0.82||0.463|TWO_SIDED|90.0|-0.8|2.0|||Mixed-Effects Model Repeated Measure|||(PF-06372865 2.5 mg - Placebo). Week 2: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||2.0|-0.8|0.463
72394662|NCT02310568|144295798|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.95||0.611|TWO_SIDED|90.0|-2.1|1.1|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 2: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||1.1|-2.1|0.611
72394663|NCT02310568|144295798|SUPERIORITY_OR_OTHER||LS Mean Difference|0.9|STANDARD_ERROR_OF_MEAN|0.88||0.321|TWO_SIDED|90.0|-0.6|2.4|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - Placebo). Week 3: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||2.4|-0.6|0.321
72394664|NCT02310568|144295798|SUPERIORITY_OR_OTHER||LS Mean Difference|0.9|STANDARD_ERROR_OF_MEAN|0.85||0.294|TWO_SIDED|90.0|-0.5|2.3|||Mixed-Effects Model Repeated Measure|||(PF-06372865 2.5 mg - Placebo). Week 3: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||2.3|-0.5|0.294
72394665|NCT02310568|144295798|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.99||0.987|TWO_SIDED|90.0|-1.7|1.6|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 3: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||1.6|-1.7|0.987
72468217|NCT00874497|144459319|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.423||||0.469|TWO_SIDED|95.0|-5.32|2.48|||ANCOVA|||LS Mean Difference between Tetomilast and Placebo at Week 104.||2.48|-5.32|0.469
72468218|NCT00874497|144459320|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.07||||0.519|TWO_SIDED|95.0|-4.42|2.27|||ANCOVA|||Statistical analysis of right upper region of the lung at Week 104.||2.27|-4.42|0.519
72468219|NCT00874497|144459320|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.05||||0.463|TWO_SIDED|95.0|-3.92|1.82|||ANCOVA|||Statistical analysis of right middle region of the lung at Week 104.||1.82|-3.92|0.463
72468220|NCT00874497|144459320|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.4||||0.598|TWO_SIDED|95.0|-6.74|3.94|||ANCOVA|||Statistical analysis of right lower region of the lung at Week 104.||3.94|-6.74|0.598
72504143|NCT01025336|144539190|SUPERIORITY_OR_OTHER||geometric mean fold rise|12.2|||||TWO_SIDED|95.0|8.05|18.34|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 19F: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||18.34|8.05|
72504144|NCT01025336|144539190|SUPERIORITY_OR_OTHER||geometric mean fold rise|17.2|||||TWO_SIDED|95.0|12.77|23.24|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 19F: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||23.24|12.77|
72394666|NCT02310568|144295798|SUPERIORITY_OR_OTHER||LS Mean Difference|0.5|STANDARD_ERROR_OF_MEAN|1.04||0.599|TWO_SIDED|90.0|-1.2|2.3|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - Placebo). Week 4: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||2.3|-1.2|0.599
72394667|NCT02310568|144295798|SUPERIORITY_OR_OTHER||LS Mean Difference|1.0|STANDARD_ERROR_OF_MEAN|1.0||0.322|TWO_SIDED|90.0|-0.7|2.6|||Mixed-Effects Model Repeated Measure|||(PF-06372865 2.5 mg - Placebo). Week 4: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||2.6|-0.7|0.322
72468221|NCT00874497|144459320|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.94||||0.142|TWO_SIDED|95.0|-6.92|1.03|||ANCOVA|||Statistical analysis of left upper region of the lung at Week 104.||1.03|-6.92|0.142
72468222|NCT00874497|144459320|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.83||||0.757|TWO_SIDED|95.0|-6.26|4.59|||ANCOVA|||Statistical analysis of left lower region of the lung at Week 104.||4.59|-6.26|0.757
72468223|NCT00874497|144459320|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.27||||0.5|TWO_SIDED|95.0|-5.03|2.5|||ANCOVA|||Statistical analysis of right whole region of the lung at Week 104.||2.50|-5.03|0.500
72468224|NCT00874497|144459320|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.93||||0.353|TWO_SIDED|95.0|-6.09|2.23|||ANCOVA|||Statistical analysis of left whole region of the lung at Week 104.||2.23|-6.09|0.353
72468225|NCT00874497|144459320|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.52||||0.438|TWO_SIDED|95.0|-5.43|2.4|||ANCOVA|||Statistical analysis of whole region of the lung at Week 104.||2.40|-5.43|0.438
72468226|NCT00874497|144459321|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|351487.0||||0.22|TWO_SIDED|95.0|-219976.0|922951.0|||ANCOVA|||Statistical analysis of right upper region of the lung at Week 104.||922951|-219976|0.220
72504145|NCT01025336|144539190|SUPERIORITY_OR_OTHER||geometric mean fold rise|11.5|||||TWO_SIDED|95.0|8.01|16.45|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 19F: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||16.45|8.01|
72468227|NCT00874497|144459321|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|103036.0||||0.146|TWO_SIDED|95.0|-37651.0|243723.0|||ANCOVA|||Statistical analysis of right middle region of the lung at Week 104||243723|-37651|0.146
72468228|NCT00874497|144459321|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|247358.0||||0.322|TWO_SIDED|95.0|-252728.0|747444.0|||ANCOVA|||Statistical analysis of right lower region of the lung at Week 104||747444|-252728|0.322
72468229|NCT00874497|144459321|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|362384.0||||0.141|TWO_SIDED|95.0|-126518.0|851286.0|||ANCOVA|||Statistical analysis of left upper region of the lung at Week 104.||851286|-126518|0.141
72468230|NCT00874497|144459321|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|294202.0||||0.325|TWO_SIDED|95.0|-303329.0|891733.0|||ANCOVA|||Statistical analysis of left lower region of the lung at Week 104.||891733|-303329|0.325
72468231|NCT00874497|144459321|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|575882.0||||0.258|TWO_SIDED|95.0|-439692.0|1591457.0|||ANCOVA|||Statistical analysis of right whole region of the lung at Week 104.||1591457|-439692|0.258
72468232|NCT00874497|144459321|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|589373.0||||0.247|TWO_SIDED|95.0|-426928.0|1605673.0|||ANCOVA|||Statistical analysis of left whole region of the lung at Week 104.||1605673|-426928|0.247
72564986|NCT01272921|144661481|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.0|STANDARD_DEVIATION|0.0||0.05|TWO_SIDED|95.0|-7.0|-2.0|||Wilcoxon (Mann-Whitney)|||The sample selected for this study,70 per drug group (or 10 in each of the 7 groups), achieves 88% power to detect a minimal difference of 4 hours in duration at a significance level (α) of 0.05 and a standard deviation of 3 hours using Williams test. We chose a difference of 4 hours as this was the interval used for assessment in the postoperative period at night. We sought to detect a difference that was equal to 1 observation period difference.||-2.00|-7.00|0.05
72564987|NCT01567826|144661502|SUPERIORITY_OR_OTHER|||||||0.01|||||||ANCOVA|||||||0.01
72621916|NCT01946880|144774216|OTHER||Mean Difference (Final Values)|3.02|||||TWO_SIDED|95.0|0.22|5.82|||||Estimate is for the difference in the change from baseline for MMF Withdrawal - MMF Maintenance at Week 60.|Descriptive statistics (mean and 95% confidence interval) are reported for the difference in the change from baseline in the PCS score between the treatment groups at Week 60.||5.82|0.22|
72621917|NCT04543786|144774235|OTHER|No comparison was made to another intervention or therapy. Comparing values at baseline and Day 2.|Mean Difference (Final Values)|2.8||||0.0048|TWO_SIDED|||||Bonferroni post-hoc tests; p \< 0.05 was considered significant|ANOVA|One-way||||||0.0048
72621918|NCT04543786|144774236|OTHER|No comparison was made to another intervention or therapy. Comparing values at baseline and Day 3.|Mean Difference (Final Values)|3.72|||<|0.001|TWO_SIDED|||||Bonferroni post-hoc tests; p \< 0.05 was considered significant|ANOVA|||||||< 0.001
72621919|NCT04543786|144774237|OTHER|No comparison was made to another intervention or therapy. Comparing values at baseline and Day 4.|Mean Difference (Final Values)|3.24|||<|0.001|TWO_SIDED|||||Bonferroni post-hoc tests; p \< 0.05 was considered significant|ANOVA|||||||<0.001
72621920|NCT04543786|144774238|OTHER|No comparison was made to another intervention or therapy. Comparing values at baseline and Day 5.|Mean Difference (Final Values)|20.84|||<|0.001|TWO_SIDED|||||Bonferroni post-hoc tests; p \< 0.05 was considered significant|ANOVA|||||||<0.001
72621921|NCT04543786|144774240|OTHER|No comparison was made to another intervention or therapy. Comparing values at baseline and Day 5.|Mean Difference (Final Values)|26.78|||<|0.001|TWO_SIDED|||||p \< 0.05 was considered significant|t-test, 2 sided|paired||||||<0.001
72621922|NCT04543786|144774241|OTHER|No comparison was made to another intervention or therapy|Mean Difference (Final Values)|1.3||||0.56|TWO_SIDED|||||p \< 0.05 was considered significant|ANOVA|Repeated measures||||||0.56
72621923|NCT04543786|144774242|OTHER|No comparison was made to another intervention or therapy|Mean Difference (Final Values)|2.3||||0.56|TWO_SIDED|||||p \< 0.05 was considered significant|ANOVA|Repeated measures||||||0.56
72468233|NCT00874497|144459321|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1156318.0||||0.251|TWO_SIDED|95.0|-855009.0|3167645.0|||ANCOVA|||Statistical analysis of whole lung region of the lung at Week 104.||3167645|-855009|0.251
72468234|NCT00874497|144459322|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|77.9||||0.181|TWO_SIDED|95.0|-38.0|193.8|||ANCOVA|||Statistical analysis of right upper lung region (RV) at Week 104.||193.8|-38.0|0.181
72468235|NCT00874497|144459322|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.9||||0.781|TWO_SIDED|95.0|-48.8|36.9|||ANCOVA|||Statistical analysis of right middle lung region (RV) at Week 104.||36.9|-48.8|0.781
72468236|NCT00874497|144459322|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|47.7||||0.445|TWO_SIDED|95.0|-77.8|173.2|||ANCOVA|||Statistical analysis of right lower lung region (RV) at Week 104.||173.2|-77.8|0.445
72468237|NCT00874497|144459322|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|62.6||||0.259|TWO_SIDED|95.0|-48.1|173.2|||ANCOVA|||Statistical analysis of left upper lung region (RV) at Week 104.||173.2|-48.1|0.259
72468238|NCT00874497|144459322|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|32.0||||0.639|TWO_SIDED|95.0|-105.6|169.6|||ANCOVA|||Statistical analysis of left lower lung region (RV) at Week 104.||169.6|-105.6|0.639
72468239|NCT00874497|144459322|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|102.3||||0.408|TWO_SIDED|95.0|-145.9|350.5|||ANCOVA|||Statistical analysis of right whole lung region (RV) at Week 104.||350.5|-145.9|0.408
72468240|NCT00874497|144459322|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|85.2||||0.445|TWO_SIDED|95.0|-138.8|309.2|||ANCOVA|||Statistical analysis of left whole lung region (RV) at Week 104.||309.2|-138.8|0.445
72468241|NCT00874497|144459322|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|187.6||||0.421|TWO_SIDED|95.0|-279.6|654.8|||ANCOVA|||Statistical analysis of whole lung region (RV) at Week 104.||654.8|-279.6|0.421
72468242|NCT00874497|144459322|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|50.7||||0.353|TWO_SIDED|95.0|-58.5|159.9|||ANCOVA|||Statistical analysis of right upper lung region (TLC) at Week 104.||159.9|-58.5|0.353
72564988|NCT01567826|144661503|SUPERIORITY_OR_OTHER|||||||0.02|||||||ANCOVA|||||||0.02
72564989|NCT02062801|144661510|SUPERIORITY_OR_OTHER|||||||0.18|TWO_SIDED||||||Chi-squared|||||||0.18
72564990|NCT02062801|144661511|SUPERIORITY_OR_OTHER|||||||0.97|TWO_SIDED||||||Chi-squared|||||||0.97
72564991|NCT02062801|144661512|SUPERIORITY_OR_OTHER|||||||0.56|TWO_SIDED||||||Chi-squared|||||||.56
72564992|NCT01612884|144661513|OTHER|Student's T-test||||||0.85|||||||t-test, 2 sided|||||||0.85
72564993|NCT01612884|144661514|OTHER|Chi-Square||||||0.93|||||||Chi-squared|||||||0.93
72564994|NCT01612884|144661515|OTHER|Chi-Square|||||>|0.05|||||||Chi-squared|||||||>0.05
72468243|NCT00874497|144459322|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.9||||0.66|TWO_SIDED|95.0|-35.3|55.0|||ANCOVA|||Statistical analysis of right middle lung region (TLC) at Week 104.||55.0|-35.3|0.660
72468244|NCT00874497|144459322|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.7||||0.859|TWO_SIDED|95.0|-110.7|132.1|||ANCOVA|||Statistical analysis of right lower lung region (TLC) at Week 104.||132.1|-110.7|0.859
72468245|NCT00874497|144459322|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|51.5||||0.253|TWO_SIDED|95.0|-38.4|141.4|||ANCOVA|||Statistical analysis of left upper lung region (TLC)at Week 104.||141.4|-38.4|0.253
72468246|NCT00874497|144459322|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|23.3||||0.754|TWO_SIDED|95.0|-126.0|172.6|||ANCOVA|||Statistical analysis of left lower lung region (TLC) at Week 104.||172.6|-126.0|0.754
72468247|NCT00874497|144459322|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|62.2||||0.546|TWO_SIDED|95.0|-145.1|269.5|||ANCOVA|||Statistical analysis of right whole lung region (TLC) at Week 104.||269.5|-145.1|0.546
72468248|NCT00874497|144459322|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|64.9||||0.554|TWO_SIDED|95.0|-155.5|285.3|||ANCOVA|||Statistical analysis of left whole lung region (TLC) at Week 104.||285.3|-155.5|0.554
72468249|NCT00874497|144459322|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|132.2||||0.524|TWO_SIDED|95.0|-284.9|549.4|||ANCOVA|||Statistical analysis of whole lung region (TLC) at Week 104.||549.4|-284.9|0.524
72468250|NCT00874497|144459323|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01||||0.5843|TWO_SIDED|95.0|-0.07|0.04|||ANCOVA|||||0.04|-0.07|0.5843
72468251|NCT00874497|144459324|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.249||||0.1252|TWO_SIDED|95.0|-0.073|0.571|||ANCOVA|||||0.571|-0.073|0.1252
72468252|NCT00874497|144459325|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1835||||0.4661|TWO_SIDED|95.0|-0.6892|0.3221|||ANCOVA|||||0.3221|-0.6892|0.4661
72468253|NCT00874497|144459326|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.6||||0.134|TWO_SIDED|95.0|-0.19|1.4|||ANCOVA|||||1.40|-0.19|0.134
72468254|NCT00874497|144459327|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.71||||0.074|TWO_SIDED|95.0|-1.5|0.07|||ANCOVA|||Statistical analysis for sRaw||0.07|-1.50|0.074
72468255|NCT00874497|144459327|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.22||||0.155|TWO_SIDED|95.0|-0.09|0.52|||ANCOVA|||Statistical analysis for sGaw||0.52|-0.09|0.155
72468256|NCT00874497|144459328|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.07||||0.845|TWO_SIDED|95.0|-0.77|0.64|||ANCOVA|||Statistical analysis for mean prior daily breath symptoms||0.64|-0.77|0.845
72468257|NCT00874497|144459328|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.21||||0.549|TWO_SIDED|95.0|-0.52|0.94|||ANCOVA|||Statistical analysis for mean prior daily cough symptoms||0.94|-0.52|0.549
72468258|NCT00874497|144459328|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.14||||0.717|TWO_SIDED|95.0|-0.93|0.65|||ANCOVA|||Statistical analysis for mean prior daily sputum symptoms||0.65|-0.93|0.717
72468259|NCT00874497|144459330|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||Statistical analysis for level I (self management) at week 104.||||1.000
72468260|NCT00874497|144459330|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||Statistical analysis for level II (physician visit) at week 104.||||1.0000
72468261|NCT00874497|144459330|SUPERIORITY_OR_OTHER|||||||0.5092|||||||Fisher Exact|||Statistical analysis for level III (hospital visit) at week 104.||||0.5092
72468262|NCT00874497|144459331|SUPERIORITY_OR_OTHER|||||||0.63||||||Fisher's Exact test was used to determine whether the tetomilast and placebo groups differ in the proportion of participants who experienced Level 2 or higher COPD exacerbations during the study.|Fisher Exact|||Statistical analysis at Week 104||||0.630
72468263|NCT00665223|144459342|SUPERIORITY|This analysis compared ACR16 45 mg vs. placebo during the randomization phase.|Mean Difference (Final Values)|-0.36||||0.456|TWO_SIDED|97.5|-1.44|0.72|||ANCOVA|||The analysis of covariance (ANCOVA) main effects model included a term for treatment and covariates for baseline mMS, gender, and use of antipsychotic medication.||0.72|-1.44|0.456
72468264|NCT00665223|144459342|SUPERIORITY|This analysis compared ACR16 90 mg vs. placebo during the randomization phase.|Mean Difference (Final Values)|-0.99||||0.042|TWO_SIDED|97.5|-2.08|0.1|||ANCOVA|||The analysis of covariance (ANCOVA) main effects model included a term for treatment and covariates for baseline mMS, gender, and use of antipsychotic medication.||0.10|-2.08|0.042
72468265|NCT00905359|144459350|NON_INFERIORITY_OR_EQUIVALENCE|t-test analysis performed using Multiple imputation and one-sided p-value testing non-inferiority of the percentage change from baseline at 10%. One-sided p-value is significant if \<0.025 or the upper limit of the CI is less than 10%.||||||0.172|||||||t-test, 1 sided|||||||0.172
72468266|NCT02138253|144459365|SUPERIORITY|For the primary efficacy analysis based on the Month 24 biopsy, subjects with a missing Month 24 biopsy had their Ishak fibrosis score imputed. Imputation of missing Ishak fibrosis scores was conducted using multiple imputation (MI). Results were imputed based on age, gender, baseline Ishak fibrosis score, and the Month 12 Ishak fibrosis score.|Risk Difference (RD)|2.9||||0.73|TWO_SIDED|95.0|-20.5|26.4||Stratified by baseline Ishak Fibrosis Score strata (F2, F3+F4+F5, and F6).|Cochran-Mantel-Haenszel|||All screening and post-baseline biopsy data collected were used in the primary analysis, irrespective of the defined protocol visit window. Classification of the Ishak fibrosis score was summarized descriptively by treatment group at baseline, Month 12, and Month 24. Response at Months 12 and 24 were summarized descriptively by treatment group, along with exact (Clopper-Pearson) 95% confidence intervals (CIs). The risk difference between groups was also was provided with its 95% CI.||26.4|-20.5|0.73
72468267|NCT02138253|144459366|SUPERIORITY||Risk Difference (RD)|4.4||||0.658|TWO_SIDED|95.0|-20.0|28.9|||Cochran-Mantel-Haenszel|||All screening and post-baseline biopsy data collected were used in the primary analysis, irrespective of the defined protocol visit window. Classification of the Ishak fibrosis score was summarized descriptively by treatment group at baseline, Month 12, and Month 24. Response at Months 12 and 24 were summarized descriptively by treatment group, along with exact (Clopper-Pearson) 95% confidence intervals (CIs). The risk difference between groups was also was provided with its 95% CI.||28.9|-20.0|0.658
72564995|NCT00573170|144661528|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.3||||0.378|TWO_SIDED|95.0|0.7|2.5||Compares odds ratio.|Generalized Estimating Equations|||||2.5|0.7|0.378
72564996|NCT05444543|144661561|SUPERIORITY||Odds Ratio (OR)|0.089||||0.57|TWO_SIDED||||||Chi-squared|||||||0.57
72564997|NCT05444543|144661562|SUPERIORITY||Odds Ratio (OR)|1.1|||>|0.99|TWO_SIDED||||||Chi-squared|||||||>0.99
72394668|NCT02310568|144295798|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|1.17||0.704|TWO_SIDED|90.0|-2.4|1.5|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 4: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||1.5|-2.4|0.704
72394669|NCT02310568|144295798|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|1.38||0.804|TWO_SIDED|90.0|-2.0|2.7|||LS Mean Difference|||(PF-06372865 7.5 mg - Placebo). Week 5: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||2.7|-2.0|0.804
72468268|NCT02138253|144459367|SUPERIORITY||Risk Difference (RD)|-7.9||||0.421|TWO_SIDED|95.0|-28.8|13.1|||Cochran-Mantel-Haenszel|||All screening and post-baseline biopsy data collected were used in the primary analysis, irrespective of the defined protocol visit window. Classification of the Ishak fibrosis score was summarized descriptively by treatment group at baseline, Month 12, and Month 24. Response at Months 12 and 24 were summarized descriptively by treatment group, along with exact (Clopper-Pearson) 95% confidence intervals (CIs). The risk difference between groups was also was provided with its 95% CI.||13.1|-28.8|0.421
72468269|NCT00243022|144459384|SUPERIORITY_OR_OTHER|||||||0.9||95.0|||||t-test, 2 sided|||||||0.9
72468270|NCT00243022|144459385|SUPERIORITY_OR_OTHER|||||||0.12||95.0|||||t-test, 2 sided|||||||0.12
72468271|NCT00243022|144459386|SUPERIORITY_OR_OTHER|||||||0.8||95.0|||||t-test, 2 sided|||||||0.8
72468272|NCT04706793|144459437|OTHER||Risk Difference (RD)|17.86|||||TWO_SIDED|95.0|-3.1|38.82||||||||38.82|-3.10|
72468273|NCT04706793|144459438|OTHER||Risk Difference (RD)|28.57|||||TWO_SIDED|95.0|6.28|50.86||||||||50.86|6.28|
72468274|NCT04706793|144459439|OTHER||Risk Difference (RD)|32.14|||||TWO_SIDED|95.0|9.58|54.71||||||||54.71|9.58|
72468275|NCT04706793|144459440|OTHER||Risk Difference (RD)|21.43|||||TWO_SIDED|95.0|-0.07|42.92||||||||42.92|-0.07|
72468276|NCT04706793|144459441|OTHER||Risk Difference (RD)|17.86|||||TWO_SIDED|95.0|-3.1|38.82||||||||38.82|-3.10|
72468277|NCT04706793|144459442|OTHER||Risk Difference (RD)|7.14|||||TWO_SIDED|95.0|-2.4|16.68||||||||16.68|-2.40|
72621924|NCT04543786|144774243|OTHER|No comparison was made to another intervention or therapy|Mean Difference (Final Values)|1.2||||0.56|TWO_SIDED|||||p \< 0.05 was considered significant|ANOVA|Repeated measures||||||0.56
72468278|NCT03713320|144459453|SUPERIORITY|||||||0.9539|||||||Cochran-Mantel-Haenszel|||Comparison of the treatment groups is based on a Cochran-Mantel-Haenzel test controlling for the number of tumors at screening (at least one tumor at screening versus no tumors at screening) and number of prognostic factors (0-1 versus 2 prognostic factors). Prognostic factors include age at diagnosis \> 60 years and lactate dehydrogenase level \> upper limit of normal at diagnosis. Number of subjects achieving ORR4 and exact binomial (Clopper-Pearson) confidence intervals are presented.||||.9539
72468279|NCT03713320|144459454|SUPERIORITY|||||||0.011|||||||Regression, Cox|||Hazard ratio (cobomarsen/vorinostat) and p-value comparing the treatment groups is based on a Cox proportional hazards model. A hazard ratio \< 1 favors cobomarsen over vorinostat.||||0.011
72468280|NCT02725528|144459468|SUPERIORITY|||||||0.05|||||||ANCOVA|||Between groups analysis for PROMs, QALYs and ROM at 12-months were determined using one-way analysis of covariance (ANCOVA). Group was entered as the independent variable, the 12-month outcome of interest was entered as the dependent variable and the baseline value for the corresponding outcome measure was entered as the covariate. Statistical significance was considered at p \< .05; all analyses were performed using SPSS® version 26.0||||0.05
72468281|NCT02725528|144459469|SUPERIORITY|||||||0.05|||||||ANCOVA|||Between groups analysis for PROMs, QALYs and ROM at 12-months were determined using one-way analysis of covariance (ANCOVA). Group was entered as the independent variable, the 12-month outcome of interest was entered as the dependent variable and the baseline value for the corresponding outcome measure was entered as the covariate. Statistical significance was considered at p \< .05; all analyses were performed using SPSS® version 26.0||||0.05
72468282|NCT02725528|144459470|SUPERIORITY|||||||0.05|||||||ANCOVA|||Between groups analysis for PROMs, QALYs and ROM at 12-months were determined using one-way analysis of covariance (ANCOVA). Group was entered as the independent variable, the 12-month outcome of interest was entered as the dependent variable and the baseline value for the corresponding outcome measure was entered as the covariate. Statistical significance was considered at p \< .05; all analyses were performed using SPSS® version 26.0||||0.05
72468283|NCT02725528|144459471|SUPERIORITY|||||||0.05|||||||ANCOVA|||Between groups analysis for PROMs, QALYs and ROM at 12-months were determined using one-way analysis of covariance (ANCOVA). Group was entered as the independent variable, the 12-month outcome of interest was entered as the dependent variable and the baseline value for the corresponding outcome measure was entered as the covariate. Statistical significance was considered at p \< .05; all analyses were performed using SPSS® version 26.0||||0.05
72468284|NCT02725528|144459472|SUPERIORITY|||||||0.05|||||||ANCOVA|||Between groups analysis for PROMs, QALYs and ROM at 12-months were determined using one-way analysis of covariance (ANCOVA). Group was entered as the independent variable, the 12-month outcome of interest was entered as the dependent variable and the baseline value for the corresponding outcome measure was entered as the covariate. Statistical significance was considered at p \< .05; all analyses were performed using SPSS® version 26.0||||0.05
72468285|NCT02725528|144459473|SUPERIORITY|||||||0.05|||||||ANCOVA|||Between groups analysis for PROMs, QALYs and ROM at 12-months were determined using one-way analysis of covariance (ANCOVA). Group was entered as the independent variable, the 12-month outcome of interest was entered as the dependent variable and the baseline value for the corresponding outcome measure was entered as the covariate. Statistical significance was considered at p \< .05; all analyses were performed using SPSS® version 26.0||||0.05
72468286|NCT02725528|144459474|SUPERIORITY|||||||0.05|||||||ANCOVA|||Between groups analysis for PROMs, QALYs and ROM at 12-months were determined using one-way analysis of covariance (ANCOVA). Group was entered as the independent variable, the 12-month outcome of interest was entered as the dependent variable and the baseline value for the corresponding outcome measure was entered as the covariate. Statistical significance was considered at p \< .05; all analyses were performed using SPSS® version 26.0||||0.05
72621925|NCT04543786|144774244|OTHER|No comparison was made to another intervention or therapy.|Mean Difference (Final Values)|1.5||||0.56|TWO_SIDED|||||p \< 0.05 was considered significant|ANOVA|Repeated measures||||||0.56
72394670|NCT02310568|144295798|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|1.38||0.559|TWO_SIDED|90.0|-3.2|1.6|||Mixed-Effects Model Repeated Measure|||(PF-06372865 2.5 mg - Placebo). Week 5: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||1.6|-3.2|0.559
72394671|NCT02310568|144295798|SUPERIORITY_OR_OTHER||LS Mean Difference|1.2|STANDARD_ERROR_OF_MEAN|1.27||0.369|TWO_SIDED|90.0|-1.0|3.4|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 5: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||3.4|-1.0|0.369
72468287|NCT02725528|144459475|SUPERIORITY|||||||0.05|||||||ANCOVA|||Between groups analysis for PROMs, QALYs and ROM at 12-months were determined using one-way analysis of covariance (ANCOVA). Group was entered as the independent variable, the 12-month outcome of interest was entered as the dependent variable and the baseline value for the corresponding outcome measure was entered as the covariate. Statistical significance was considered at p \< .05; all analyses were performed using SPSS® version 26.0||||0.05
72564998|NCT00508027|144661609|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.5|STANDARD_DEVIATION|1.7|<|0.05|||||||t-test, 2 sided|||Ho: There is no change in plasma biomarker levels before and after simivastatin treatment. With 12 patients in each group and assuming a 5% risk of Type I error (two-tailed α = 0.05) and estimated SD for the change in NOx (or sVCAM-1) of 48%, power will be 80% to detect a 40% change from baseline for each group, and a 55% difference in the change in biomarker levels between dose groups. Matched paired t-tests were used to measure changes in biomarker levels from baseline.||||<0.05
72564999|NCT00860743|144661636|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED|||||P values less than 0.05 are considered statistically significant in this study.|ANOVA|||||||0.001
72565000|NCT00860743|144661637|SUPERIORITY_OR_OTHER|||||||0.2|TWO_SIDED||||||ANOVA|||||||0.2
72565001|NCT00350402|144661664|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.254|STANDARD_ERROR_OF_MEAN|2.028|<|0.001|TWO_SIDED|95.0|3.147|11.362|||t-test, 2 sided|df = 38; t = 3.576|Treatment effect size: Cohen's D =1.142|Hypothesis: Parkinson patients assigned to high intensity IMST will show greater improvement in facial movement (entropy) relative to those undergoing Sham IMST.||11.362|3.147|< 0.001
72394672|NCT02310568|144295798|SUPERIORITY_OR_OTHER||LS Mean Difference|1.6|STANDARD_ERROR_OF_MEAN|1.56||0.313|TWO_SIDED|90.0|-1.1|4.3|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - Placebo). Week 6: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||4.3|-1.1|0.313
72394673|NCT02310568|144295798|SUPERIORITY_OR_OTHER||LS Mean Difference|0.9|STANDARD_ERROR_OF_MEAN|1.56||0.56|TWO_SIDED|90.0|-1.8|3.6|||Mixed-Effects Model Repeated Measure|||(PF-06372865 2.5 mg - Placebo). Week 6: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||3.6|-1.8|0.560
72468288|NCT02725528|144459476|SUPERIORITY|||||||0.05|||||||ANCOVA|||Between groups analysis for PROMs, QALYs and ROM at 12-months were determined using one-way analysis of covariance (ANCOVA). Group was entered as the independent variable, the 12-month outcome of interest was entered as the dependent variable and the baseline value for the corresponding outcome measure was entered as the covariate. Statistical significance was considered at p \< .05; all analyses were performed using SPSS® version 26.0||||0.05
72468289|NCT02601209|144459528|OTHER||Maximum Tolerated Dose (mg)|30.0|||||TWO_SIDED|||||||||||||
72468290|NCT02601209|144459529|SUPERIORITY||Hazard Ratio (HR)|1.36||||0.1419|ONE_SIDED|85.0||1.7|||Log Rank|1-sided statistical test and p-value||||1.70||0.1419
72468291|NCT03636373|144459541|NON_INFERIORITY|On a 10 point Likert Pain Scale, non-inferiority margin for the difference is 1.04. Using a Student t-test, there was 80% power for the difference in pain levels to exceed -1.04.||||||1|||||||t-test, 1 sided|||Mean Outcome measure Etanercept arm { ( 8 + 0 + 7)/3 = 5} Triamcinolone Arm { (3+0) /2 = 1.5 }||||1.00
72468292|NCT03636373|144459542|SUPERIORITY|||||||1|||||||t-test, 2 sided|||||||1.00
72468293|NCT03636373|144459543|SUPERIORITY|||||||0.05|||||||t-test, 2 sided|||||||0.05
72468294|NCT03636373|144459544|SUPERIORITY|||||||0.05|||||||t-test, 2 sided|||||||0.05
72468295|NCT03636373|144459545|SUPERIORITY|||||||0.05|||||||t-test, 2 sided|||||||0.05
72468296|NCT03636373|144459546|SUPERIORITY|||||||0.05|||||||Chi-squared|||||||0.05
72468297|NCT01161628|144459597|SUPERIORITY_OR_OTHER||||||<|0.5|TWO_SIDED||||||t-test, 2 sided|||Null hypothesis: p (CR rate) is 0.5 or less versus... Alternative hypothesis: p \>0.5 A sample size of 25 patients gives 90% power with an alpha = 0.05||||<0.5
72468298|NCT00715117|144459606|SUPERIORITY_OR_OTHER|||||||0.005||95.0|||||t-test, 2 sided|||||||0.005
72565002|NCT00350402|144661665|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.36|STANDARD_ERROR_OF_MEAN|4.955|<|0.459|TWO_SIDED|95.0|-16.41|3.68|||t-test, 2 sided|||Hypothesis: Scores on PDQ-39 would show bigger change for the IMST group than the Sham treatment group. The sample size was not powered for the PDQ-39 (but rather for the primary outcome variable).||3.68|-16.41|<0.459
72565003|NCT00350402|144661666|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.426|STANDARD_ERROR_OF_MEAN|4.221|<|0.018|TWO_SIDED|95.0|1.874|18.978|||t-test, 2 sided|t-value = 2.47, with 37 df||Hypothesis: Changes in MIP following treatment would be greater for participants in the IMST versus the Sham treatment group. This is a validity check on for the IMST intervention.||18.978|1.874|<0.018
72565004|NCT00350402|144661667|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.129|STANDARD_ERROR_OF_MEAN|2.492|<|0.047|TWO_SIDED|95.0|0.0834|10.17||No adjustment necessary|t-test, 2 sided|38 df, t= 2.058 However, due to inequality of variance (Levine test), the adjusted p-value = \<0.049, and adjusted df = 27.3||Hypothesis: Facial entropy changes would be greater in IMST group than sham treatment group. Sample size was based on preliminary data suggesting total N of 40 would be adequate for detecting change in entropy (of approximately 50%).||10.17|.0834|<0.047
72468299|NCT00715117|144459606|SUPERIORITY_OR_OTHER||||||>|0.05|||||||t-test, 2 sided|||||||>0.05
72468300|NCT00715117|144459607|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||t-test, 2 sided|||Bowel symptoms||||>0.05
72468301|NCT00715117|144459607|SUPERIORITY_OR_OTHER|||||||0.035||95.0|||||t-test, 2 sided|||Social well-being||||0.035
72468302|NCT00715117|144459607|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||t-test, 2 sided|||Emotional well-being||||>0.05
72468303|NCT00715117|144459607|SUPERIORITY_OR_OTHER|||||||0.035|TWO_SIDED|95.0||||Systemic symptoms|t-test, 2 sided|||||||0.035
72468304|NCT00715117|144459607|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||t-test, 2 sided|||Body Image||||>0.05
72468305|NCT00715117|144459608|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||Sleep disturbance||||1.0
72468306|NCT00715117|144459608|SUPERIORITY_OR_OTHER|||||||0.45|||||||Fisher Exact|||Unusual dreams||||0.45
72468307|NCT00715117|144459608|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||Twitching||||1.0
72468308|NCT00715117|144459608|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||Headaches||||1.0
72565005|NCT00562120|144661733|SUPERIORITY_OR_OTHER|||||||0.302|TWO_SIDED|||||P-value was based on one-sided test. There were no further adjustments for multiplicity.|ANOVA|||An analysis of variance (ANOVA) mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||||0.302
72468309|NCT00715117|144459608|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||Decreased appetite||||1.0
72468310|NCT00715117|144459608|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|||Nausea||||1.0
72468311|NCT00715117|144459608|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||Hair loss||||1.0
72468312|NCT00715117|144459608|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||Fatigue||||1.0
72468313|NCT00715117|144459608|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||Flushed ears||||1.0
72468314|NCT00715117|144459608|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||Papules, rash||||1.0
72468315|NCT00715117|144459608|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||Double vision||||1.0
72468316|NCT01482429|144459609|SUPERIORITY_OR_OTHER|||||||0.03||95.0|||||binomial test|||||||0.03
72468317|NCT01482429|144459610|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.0001
72468318|NCT02166476|144459620|NON_INFERIORITY_OR_EQUIVALENCE|The noninferiority margin was a difference of 15%. Noninferiority was concluded if the lower limit of the two-sided 95% confidence interval (CI) for the treatment difference for overall success at EOIVT was \>-15%.|Treatment difference|4.5|||||TWO_SIDED|95.0|0.7|9.1|||||Treatment difference is the estimate of the difference in the overall success rate between the two treatment arms. The difference estimates and the 95% CIs are obtained based on Miettinen and Nurminen method.|Treatment comparison of the m-MITT population||9.1|0.7|
72468319|NCT02166476|144459621|NON_INFERIORITY_OR_EQUIVALENCE|The noninferiority margin was a difference of 15%. Meropenem-vaborbactam was claimed to be noninferior only if noninferiority was demonstrated for microbial eradication at TOC in the m-MITT Population.|Treatment difference|9.0|||||TWO_SIDED|95.0|-0.9|18.7|||||Treatment difference is the estimate of the difference in the Eradication rate between the two treatment arms. The difference estimates and the 95% CIs are obtained based on Miettinen and Nurminen method.|Treatment comparison of the m-MITT population||18.7|-0.9|
72468320|NCT02166476|144459622|NON_INFERIORITY_OR_EQUIVALENCE|The noninferiority margin was a difference of 15%. Meropenem-vaborbactam was claimed to be noninferior only if noninferiority was demonstrated for microbial eradication at TOC in the ME Population.|Treatment Difference|5.9|||||TWO_SIDED|95.0|-4.2|16.0|||||Treatment difference is the estimate of the difference in the overall success rate between the two treatment arms. The difference estimates and the 95% CIs are obtained based on Miettinen and Nurminen method.|Treatment comparison of the ME population||16.0|-4.2|
72468321|NCT01076244|144459659|SUPERIORITY_OR_OTHER||change from baseline|13.43|STANDARD_DEVIATION|16.55|<|0.0001|TWO_SIDED|95.0|8.42|18.43|||t-test, 2 sided|||||18.43|8.42|<0.0001
72468322|NCT01076244|144459661|SUPERIORITY_OR_OTHER||change from baseline|2.17|STANDARD_DEVIATION|3.29|<|0.0001|TWO_SIDED|95.0|1.17|3.16|||t-test, 2 sided|||||3.16|1.17|<0.0001
72468323|NCT02053610|144459663|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.49|||<|0.0001|TWO_SIDED|95.0|0.41|0.58|||Log Rank, Stratified|Stratified by Binet stage at Baseline.||||0.58|0.41|<0.0001
72468324|NCT02053610|144459665|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.42|||<|0.0001|TWO_SIDED|95.0|0.33|0.54|||Log Rank, Stratified|Stratified by Binet stage at Baseline.|Stratified by Binet stage at Baseline.|||0.54|0.33|<0.0001
72468325|NCT02053610|144459667|SUPERIORITY_OR_OTHER||Difference in Response Rates|13.22||||0.0001|TWO_SIDED|95.0|6.3|20.1|||Chi-squared|||Includes participants with EOTR: CR, CRi, PR or nPR.||20.1|6.3|0.0001
72468326|NCT02053610|144459668|SUPERIORITY_OR_OTHER||Difference in Response Rates|12.92||||0.0002|TWO_SIDED|95.0|6.1|19.8|||Chi-squared|||Includes participants with best overall response: CR, CRi, PR or nPR.||19.8|6.1|0.0002
72468327|NCT02053610|144459669|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.51|||<|0.0001|TWO_SIDED|95.0|0.43|0.61|||Log Rank, Stratified|Stratified by Binet stage at Baseline.||||0.61|0.43|<0.0001
72468328|NCT02053610|144459670|SUPERIORITY_OR_OTHER||Hazard Ratio (stratified)|0.76||||0.0245|TWO_SIDED|95.0|0.6|0.97|||Log Rank, Stratified|Stratified by Binet stage at Baseline.||||0.97|0.60|0.0245
72468329|NCT02053610|144459671|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.5|||<|0.0001|TWO_SIDED|95.0|0.41|0.61|||Log Rank, Stratified|Stratified by Binet stage at Baseline.||||0.61|0.41|<0.0001
72468330|NCT02053610|144459673|SUPERIORITY_OR_OTHER||Hazard Ratio (stratified)|0.58|||<|0.0001|TWO_SIDED|95.0|0.46|0.73|||Log Rank, Stratified|Stratified by Binet stage at Baseline.||||0.73|0.46|<0.0001
72468331|NCT04486313|144459700|SUPERIORITY|||||||0.8786|||||||Gehan-Wilcoxon Test|Stratified by Baseline COVID-19 severity (mild/moderate), time from onset of symptoms to randomization (\<36 hours/≥36 hours), risk of severe illness||||||0.8786
72468332|NCT04486313|144459701|SUPERIORITY|||||||0.074||||||Stratified by Baseline COVID-19 severity (mild/moderate), time from onset of symptoms to randomization (\<36 hours/≥36 hours), risk of severe illness|Cochran-Mantel-Haenszel|||||||0.0740
72468333|NCT04486313|144459702|SUPERIORITY|||||||0.4479|||||||Cochran-Mantel-Haenszel|||Comparison of proportion positive for SARS-CoV-2 at Day 4||||0.4479
72565006|NCT00562120|144661733|SUPERIORITY_OR_OTHER|||||||0.134|TWO_SIDED|||||P-value was based on a one-sided test. There were no further adjustments for multiplicity.|ANOVA|||An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||||0.134
72394674|NCT02310568|144295798|SUPERIORITY_OR_OTHER||LS Mean Difference|0.7|STANDARD_ERROR_OF_MEAN|1.43||0.635|TWO_SIDED|90.0|-1.8|3.2|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 6: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||3.2|-1.8|0.635
72394675|NCT02310568|144295798|SUPERIORITY_OR_OTHER||LS Mean Difference|1.0|STANDARD_ERROR_OF_MEAN|1.62||0.538|TWO_SIDED|90.0|-1.8|3.8|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - Placebo). Week 7: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||3.8|-1.8|0.538
72394676|NCT02310568|144295798|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|1.6||0.942|TWO_SIDED|90.0|-2.7|2.9|||Mixed-Effects Model Repeated Measure|||(PF-06372865 2.5 mg - Placebo). Week 7: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||2.9|-2.7|0.942
72468334|NCT04486313|144459702|SUPERIORITY|||||||0.2814|||||||Cochran-Mantel-Haenszel|||Comparison of proportion positive for SARS-CoV-2 at Day 10||||0.2814
72468335|NCT04486313|144459703|SUPERIORITY|||||||0.0665|||||||t-test, 2 sided|||Comparison of change from Baseline to Day 4||||0.0665
72468336|NCT04486313|144459703|SUPERIORITY|||||||0.4974|||||||t-test, 2 sided|||Comparison of change from Baseline to Day 10||||0.4974
72468337|NCT04486313|144459704|SUPERIORITY|||||||0.1771|||||||Cochran-Mantel-Haenszel|Stratified by Baseline COVID-19 severity (mild/moderate), time from onset of symptoms to randomization (\<36 hours/≥36 hours), risk of severe illness||||||0.1771
72468338|NCT04486313|144459705|SUPERIORITY|||||||0.2399|||||||Cochran-Mantel-Haenszel|Stratified by Baseline COVID-19 severity (mild/moderate), time from onset of symptoms to randomization (\<36 hours/≥36 hours), risk of severe illness||||||0.2399
72468339|NCT04486313|144459706|SUPERIORITY|||||||0.09|||||||Gehan-Wilcoxon Test|Stratified by Baseline COVID-19 severity (mild/moderate), time from onset of symptoms to randomization (\<36 hours/≥36 hours), risk of severe illness||||||0.09
72468340|NCT04486313|144459707|SUPERIORITY|||||||0.0077|||||||Gehan-Wilcoxon Test|Stratified by Baseline COVID-19 severity (mild/moderate), time from onset of symptoms to randomization (\<36 hours/≥36 hours), risk of severe illness||||||0.0077
72468341|NCT04486313|144459708|SUPERIORITY|||||||0.05|||||||Cochran-Mantel-Haenszel|Stratified by Baseline COVID-19 severity (mild/moderate), time from onset of symptoms to randomization (\<36 hours/≥36 hours), risk of severe illness||||||0.05
72565007|NCT00562120|144661733|SUPERIORITY_OR_OTHER|||||||0.229|TWO_SIDED|||||P-value was based on a one-sided test. There were no further adjustments for multiplicity.|ANOVA|||An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||||0.229
72565008|NCT00562120|144661733|SUPERIORITY_OR_OTHER|||||||0.544|TWO_SIDED|||||P-value was based on two-sided test which was underpowered and presented for descriptive purposes only. There were no further adjustments for multiplicity.|ANOVA|||An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||||0.544
72621926|NCT00456365|144774245|SUPERIORITY_OR_OTHER|||||||0.03|||||||Chi-squared|||||||0.03
72621927|NCT00456365|144774246|SUPERIORITY_OR_OTHER|||||||0.02|||||||ANCOVA|||||||0.02
72621928|NCT00456365|144774247|SUPERIORITY_OR_OTHER|||||||0.69|||||||ANOVA|||||||0.69
72621929|NCT00456365|144774248|SUPERIORITY_OR_OTHER|||||||0.21|||||||ANCOVA|||||||0.21
72621930|NCT02202577|144774251|SUPERIORITY||Risk Ratio (RR)|0.9||||0.38|ONE_SIDED|95.0||1.35||This is the calculated p-value for the intention to treat analysis of primary outcome. A 1-tailed p value of \<0.05 was selected for statistical significance.|Fisher Exact|||"We estimated a cesarean related surgical site infection rate of 7.5% with povidone-iodine and hypothesized chlorhexidine-alcohol treatment to be superior based on existing literature. We considered a 50% reduction to be significant. We performed our power analysis assuming~1-directional effects in favor of chlorhexidine, which best fit our hypothesis. Using a 1-tailed alpha of 0.05 and an 80% power to detect a difference, we estimated that 466 subjects would be required in each group."||1.35||0.38
72468342|NCT04486313|144459709|SUPERIORITY|||||||0.05|||||||Cochran-Mantel-Haenszel|Stratified by Baseline COVID-19 severity (mild/moderate), time from onset of symptoms to randomization (\<36 hours/≥36 hours), risk of severe illness||||||0.05
72468343|NCT04486313|144459710|SUPERIORITY|||||||0.08|||||||Cochran-Mantel-Haenszel|Stratified by Baseline COVID-19 severity (mild/moderate), time from onset of symptoms to randomization (\<36 hours/≥36 hours), risk of severe illness||||||0.08
72468344|NCT02768597|144459711|SUPERIORITY|||||||0.552|||||||ANOVA|||||||.552
72468345|NCT02768597|144459712|SUPERIORITY|||||||0.558|||||||ANOVA|||||||.558
72468346|NCT02768597|144459713|SUPERIORITY|||||||0.274|||||||Kruskal-Wallis|||||||.274
72468347|NCT02768597|144459714|SUPERIORITY|||||||0.539|||||||Kruskal-Wallis|||||||.539
72468348|NCT02768597|144459715|SUPERIORITY|||||||0.478|||||||Kruskal-Wallis|||||||.478
72468349|NCT02768597|144459716|SUPERIORITY|||||||0.527|||||||ANOVA|||||||.527
72468350|NCT02768597|144459717|SUPERIORITY|||||||0.823|||||||ANOVA|||||||.823
72468351|NCT02768597|144459718|SUPERIORITY|||||||0.231|||||||ANOVA|||||||.231
72468352|NCT02768597|144459719|SUPERIORITY|||||||0.595|||||||Kruskal-Wallis|||||||.595
72468353|NCT02768597|144459720|SUPERIORITY|||||||0.789|||||||Kruskal-Wallis|||||||.789
72468354|NCT01496365|144459721|SUPERIORITY||Least squares mean|-0.05||||0.8916|TWO_SIDED|95.0|-0.81|0.7|||ANCOVA|||||0.70|-0.81|0.8916
72468355|NCT01496365|144459721|SUPERIORITY||Least squares mean|-0.22||||0.5569|TWO_SIDED|95.0|-0.95|0.51|||ANCOVA|||||0.51|-0.95|0.5569
72468356|NCT01496365|144459721|SUPERIORITY||Least squares mean|-0.53||||0.1544|TWO_SIDED|95.0|-1.25|0.2|||ANCOVA|||||0.20|-1.25|0.1544
72468357|NCT01496365|144459721|SUPERIORITY||Least squares mean|-0.94||||0.0137|TWO_SIDED|95.0|-1.69|-0.19|||ANCOVA|||||-0.19|-1.69|0.0137
72565009|NCT00562120|144661733|SUPERIORITY_OR_OTHER|||||||0.71|TWO_SIDED|||||P-value was based on two-sided test which was underpowered and presented for descriptive purposes only. There were no further adjustments for multiplicity.|ANOVA|||An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||||0.710
72394677|NCT02310568|144295798|SUPERIORITY_OR_OTHER||LS Mean Difference|0.9|STANDARD_ERROR_OF_MEAN|1.5||0.555|TWO_SIDED|90.0|-1.7|3.5|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 7: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||3.5|-1.7|0.555
72394678|NCT02310568|144295798|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|1.96||0.728|TWO_SIDED|90.0|-4.1|2.7|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - Placebo). Week 8: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||2.7|-4.1|0.728
72394679|NCT02310568|144295798|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.8|STANDARD_ERROR_OF_MEAN|1.95||0.362|TWO_SIDED|90.0|-5.2|1.6|||Mixed-Effects Model Repeated Measure|||(PF-06372865 2.5 mg - Placebo). Week 8: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||1.6|-5.2|0.362
72394680|NCT02310568|144295798|SUPERIORITY_OR_OTHER||LS Mean Difference|1.1|STANDARD_ERROR_OF_MEAN|1.81||0.538|TWO_SIDED|90.0|-2.0|4.3|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 8: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||4.3|-2.0|0.538
72468358|NCT01496365|144459721|SUPERIORITY||Least squares mean|-0.88||||0.0171|TWO_SIDED|95.0|-1.61|0.16|||ANCOVA|||||0.16|-1.61|0.0171
72468359|NCT01496365|144459721|SUPERIORITY||Least square means|-1.01||||0.006|TWO_SIDED|95.0|-1.74|-0.29|||ANCOVA|||||-0.29|-1.74|0.0060
72468360|NCT01496365|144459721|SUPERIORITY||Least squares mean|-0.17||||0.7051|TWO_SIDED|95.0|-1.03|0.69|||ANCOVA|||||0.69|-1.03|0.7051
72394681|NCT02310568|144295798|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|1.11||0.949|TWO_SIDED|90.0|-2.0|1.8|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - Placebo). Combined Stage 1 and Stage 2: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect.||1.8|-2.0|0.949
72468361|NCT01496365|144459721|SUPERIORITY||Least squares mean|-0.47||||0.2772|TWO_SIDED|95.0|-1.33|0.38|||ANCOVA|||||0.38|-1.33|0.2772
72468362|NCT01496365|144459721|SUPERIORITY||Least squares mean|-0.89||||0.0458|TWO_SIDED|95.0|-1.77|-0.02|||ANCOVA|||||-0.02|-1.77|0.0458
72468363|NCT01496365|144459721|SUPERIORITY||Least squares mean|-0.83||||0.0569|TWO_SIDED|95.0|-1.69|0.02|||ANCOVA|||||0.02|-1.69|0.0569
72468364|NCT01496365|144459721|SUPERIORITY||Least squares mean|-0.96||||0.0271|TWO_SIDED|95.0|-1.81|-0.11|||ANCOVA|||||-0.11|-1.81|0.0271
72394682|NCT02310568|144295798|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|1.09||0.708|TWO_SIDED|90.0|-2.3|1.5|||Mixed-Effects Model Repeated Measure|||(PF-06372865 2.5 mg - Placebo). Combined Stage 1 and Stage 2: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect.||1.5|-2.3|0.708
72394683|NCT02310568|144295798|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|1.07||0.752|TWO_SIDED|90.0|-1.5|2.2|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Combined Stage 1 and Stage 2: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect.||2.2|-1.5|0.752
72394684|NCT02310568|144295799|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.95|||||TWO_SIDED|90.0|0.37|2.45|||Regression, Logistic|||(PF-06372865 7.5 mg - Placebo). Logistic regression model includes treatment as fixed effect, and baseline as covariate. Baseline for Stage 1 is Day 1 and Stage 2 is Week 4 (Day 28).||2.45|0.37|
72394685|NCT02310568|144295799|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.64|||||TWO_SIDED|90.0|0.39|6.88|||Regression, Logistic|||(PF-06372865 2.5 mg - Placebo). Logistic regression model includes treatment as fixed effect, and baseline as covariate. Baseline for Stage 1 is Day 1 and Stage 2 is Week 4 (Day 28).||6.88|0.39|
72468365|NCT01015677|144459745|SUPERIORITY_OR_OTHER||Differrence in the least squares means|-6.28||||0.488|TWO_SIDED|95.0|-24.2|11.64|||Longitudinal Data Analysis (LDA)|LDA model terms for treatment, week (Weeks 1, 2 and 4), region, and interaction of treatment by week.||||11.64|-24.20|0.488
72468366|NCT01015677|144459745|SUPERIORITY_OR_OTHER||Difference in the least squares means|-17.45||||0.069|TWO_SIDED|95.0|-36.28|1.38|||Longitudinal Data Analysis|LDA model with terms for treatment, week (Weeks 1, 2 and 4), region, and interaction of treatment by week.||||1.38|-36.28|0.069
72468367|NCT01015677|144459748|SUPERIORITY_OR_OTHER||Differrence in the least squares means|-6.05||||0.529|TWO_SIDED|95.0|-25.06|12.96|||Longitudinal Data Analysis (LDA)|LDA model includes terms for treatment, week (Weeks 1, 2 and 4), region, and interaction of treatment by week.||||12.96|-25.06|0.529
72468368|NCT01015677|144459748|SUPERIORITY_OR_OTHER||Difference in the least squares means|-11.22||||0.264|TWO_SIDED|95.0|-31.03|8.59|||Longitudinal Data Analysis|LDA model includes terms for treatment, week (Weeks 1, 2 and 4), region, and interaction of treatment by week.||||8.59|-31.03|0.264
72468369|NCT01015677|144459749|SUPERIORITY_OR_OTHER||Difference in LS means|0.94||||0.827|TWO_SIDED|90.0|-6.19|8.07|||ANCOVA|Analysis of covariance (ANCOVA) with terms for treatment, region, stage of the trial, and baseline value as a covariate in PP population only.||||8.07|-6.19|0.827
72468370|NCT01015677|144459749|SUPERIORITY_OR_OTHER||Difference in the LS means|-14.52||||0.001|TWO_SIDED|90.0|-21.73|-7.32|||ANCOVA|ANCOVA with terms for treatment, region, stage of the trial, and baseline value as a covariate in PP population only.||||-7.32|-21.73|0.001
72468371|NCT02232399|144459750|OTHER|||||||0.45||||||To test whether there were any significant differences between the two treatment groups over time (group vs time interaction), a repeated measurement mixed-model approach was used. This assumed an unstructured covariance pattern.|Mixed Models Analysis|Unstructured covariance pattern was assumed.||To test whether there were any significant differences between the two treatment groups over time (group vs time interaction), a repeated measurement mixed-model approach was used. This assumed an unstructured covariance pattern.||||0.45
72621931|NCT02202577|144774251|SUPERIORITY||Risk Ratio (RR)|0.83||||0.26|ONE_SIDED|95.0||1.25||This is the calculated p-value for the per protocol analysis of primary outcome. A 1-tailed p value of \<0.05 was selected for statistical significance.|Fisher Exact|||Per Protocol Analysis||1.25||0.26
72468372|NCT02232399|144459751|OTHER|||||||0.7|||||||Regression, Logistic|||||||0.70
72468373|NCT01646385|144459758|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.836||||0.084|TWO_SIDED|95.0|0.683|1.025|||Regression, Cox|||Cox proportional hazards model adjusted for age, baseline steroid, smoking history, previous cancer, and body mass index was used for analysis.||1.025|0.683|0.084
72468374|NCT01646385|144459759|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.512||||0.035|TWO_SIDED|95.0|0.276|0.952|||Regression, Cox|||Cox proportional hazards model adjusted for age was used for analysis.||0.952|0.276|0.035
72468375|NCT01646385|144459760|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.019||||0.855|TWO_SIDED|95.0|0.831|1.251|||Regression, Cox|||Cox proportional hazards model adjusted for age, gender, previous non-RA drugs, baseline steroid, baseline DMARDs, methotrexate, disease activity score based on 28-joints count (DAS28), and smoking history was used for analysis.||1.251|0.831|0.855
72468376|NCT01646385|144459761|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.7||||0.001|TWO_SIDED|95.0|0.564|0.87|||Regression, Cox|||Cox proportional hazards model adjusted for age, gender, previous non-RA drugs, baseline steroid, methotrexate, and baseline health assessment questionnaire (HAQ) score was used for analysis.||0.870|0.564|0.001
72468377|NCT01646385|144459762|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.717||||0.024|TWO_SIDED|95.0|0.537|0.958|||Regression, Cox|||Cox proportional hazards model adjusted for age, gender, previous non-RA drugs, baseline steroid, methotrexate, baseline HAQ score, Charlson index, smoking history, and body mass index was used for analysis.||0.958|0.537|0.024
72468378|NCT01646385|144459765|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||t-test, 2 sided|||||||<0.001
72468379|NCT01646385|144459766|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|||Change at Year 1: analysis was performed with Analysis of Covariance (ANCOVA) using the General Linear Model (GLM) method applying age, gender, baseline DAS28, previous non-RA drugs, baseline steroid, and baseline methotrexate as covariates.||||<0.0001
72468380|NCT01646385|144459766|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|||Change at Year 2: analysis was performed with ANCOVA using the GLM method applying age, gender, baseline DAS28, previous non-RA drugs, baseline steroid, and baseline methotrexate as covariates.||||<0.0001
72468381|NCT01646385|144459766|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|||Change at Year 3: analysis was performed with ANCOVA using the GLM method applying age, gender, baseline DAS28, previous non-RA drugs, baseline steroid, and baseline methotrexate as covariates.||||<0.0001
72468382|NCT01646385|144459766|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|||Change at Year 4: analysis was performed with ANCOVA using the GLM method applying age, gender, baseline DAS28, previous non-RA drugs, baseline steroid, and baseline methotrexate as covariates.||||<0.0001
72468383|NCT01646385|144459766|SUPERIORITY_OR_OTHER|||||||0.01|TWO_SIDED||||||ANCOVA|||Change at Year 5: analysis was performed with ANCOVA using the GLM method applying age, gender, baseline DAS28, previous non-RA drugs, baseline steroid, and baseline methotrexate as covariates.||||0.01
72468384|NCT01646385|144459769|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||t-test, 2 sided|||||||<0.001
72468385|NCT01646385|144459770|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Change at Year 1: analysis was performed with ANCOVA using the GLM method applying age, gender, baseline HAQ, previous non-RA drugs, baseline steroid, and baseline methotrexate as covariates.||||<0.001
72468386|NCT01646385|144459770|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Change at Year 2: analysis was performed with ANCOVA using the GLM method applying age, gender, baseline HAQ, previous non-RA drugs, baseline steroid, and baseline methotrexate as covariates.||||<0.001
72504146|NCT01025336|144539190|SUPERIORITY_OR_OTHER||geometric mean fold rise|12.0|||||TWO_SIDED|95.0|7.89|18.19|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 23F: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||18.19|7.89|
72621932|NCT00829868|144774253|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of Geometric Means|109.0||||||90.0|99.3|120.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||120|99.3|
72468387|NCT01646385|144459770|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Change at Year 3: analysis was performed with ANCOVA using the GLM method applying age, gender, baseline HAQ, previous non-RA drugs, baseline steroid, and baseline methotrexate as covariates.||||<0.001
72468388|NCT01777334|144459775|SUPERIORITY_OR_OTHER||Least squares mean difference|0.112|||<|0.001|TWO_SIDED|95.0|0.081|0.144|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least squares mean difference=UMEC/VI 62.5/25 µg minus TIO 18 µg.|||0.144|0.081|<0.001
72468389|NCT00364377|144459827|SUPERIORITY_OR_OTHER||||||>|0.05|||||||t-test, 2 sided|||Paired comparisons (within groups) to examine differences between the baseline study and after 8-weeks of treatment were made using Student's two-tailed t-test for paired samples. Between-group comparisons were made using Student's two-tailed t-test for unpaired samples. Given the previously observed variation in fasting glucose||||>0.05
72468390|NCT00632021|144459829|EQUIVALENCE|In the primary analysis we compared the number of clinically important medication errors by treatment group using unadjusted negative binomial regression.|Incidence Rate Ratio (IRR)|0.92|||||TWO_SIDED|95.0|0.77|1.09||||||||1.09|0.77|
72468391|NCT00632021|144459830|EQUIVALENCE|The association between intervention and time to first unplanned health care event (hospital readmission) was examined using multivariable Cox proportional hazards regression models.|Cox Proportional Hazard|0.94|||||TWO_SIDED|95.0|0.63|1.28||||||||1.28|0.63|
72468392|NCT03563313|144459831|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
72468393|NCT03563313|144459832|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
72468394|NCT03563313|144459833|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
72468395|NCT03563313|144459834|SUPERIORITY|||||||0.001|||||||Mixed Models Analysis|||||||0.001
72468396|NCT03563313|144459835|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
72468397|NCT03563313|144459836|SUPERIORITY|||||||0.02|||||||Mixed Models Analysis|||||||0.02
72504147|NCT01025336|144539190|SUPERIORITY_OR_OTHER||geometric mean fold rise|6.7|||||TWO_SIDED|95.0|5.02|8.92|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 23F: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||8.92|5.02|
72468398|NCT00458393|144459884|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.577|STANDARD_ERROR_OF_MEAN|0.105||0.002|TWO_SIDED|95.0|0.404|0.824||secondary p-value given.|Log Rank|stratified by site|Efron correction for ties. Placebo is reference. Results typically quoted as efficacy = 100\*(1-HR)|Primary null hypothesis: Relative hazard of 0.7 or less. Secondary null hypothesis: Relative hazard of 1.0 or less.||.824|.404|0.002
72468399|NCT00458393|144459885|SUPERIORITY||Risk Ratio (RR)|1.33||||0.28|TWO_SIDED|95.0|0.79|2.25||p-value is not adjusted for multiple comparisons, a priori threshold for statistical significance was p \< 0.05|Fisher Exact||||Extensive analysis and methods published in https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3966916/|2.25|0.79|0.28
72468400|NCT00458393|144459886|SUPERIORITY||Risk Ratio (RR)|1.3||||0.54|TWO_SIDED|95.0|0.57|2.96|||Fisher Exact|||||2.96|.57|0.54
72468401|NCT00458393|144459887|SUPERIORITY||Hazard Ratio (HR)|0.89||||0.5|TWO_SIDED|95.0|0.65|1.23|||Log Rank|||||1.23|0.65|0.50
72468402|NCT00458393|144459888|SUPERIORITY||Hazard Ratio (HR)|0.99||||0.92|TWO_SIDED|95.0|0.79|1.23|||Log Rank|||||1.23|0.79|0.92
72394686|NCT02310568|144295799|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.58|||||TWO_SIDED|90.0|0.23|1.49|||Regression, Logistic|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Logistic regression model includes treatment as fixed effect, and baseline as covariate. Baseline for Stage 1 is Day 1 and Stage 2 is Week 4 (Day 28).||1.49|0.23|
72468403|NCT00458393|144459889|SUPERIORITY_OR_OTHER_LEGACY|||||||1|||||||Fisher Exact|||Null hypothesis of no difference||||1.00
72468404|NCT00458393|144459889|SUPERIORITY|Desc|Risk Difference (RD)|0.0||||1|TWO_SIDED||||||Fisher Exact|||||||1.00
72468405|NCT00458393|144459890|SUPERIORITY||Mean Difference (Net)|-0.91||||0.001|TWO_SIDED|||||\< 0.05 for statistical significance. no adjustment for multiple comparisons|Mixed Models Analysis|||||||0.001
72468406|NCT00458393|144459891|SUPERIORITY||Median Difference (Net)|-3.8||||0.009|TWO_SIDED|95.0|-6.6|-0.95|||median regression|||||-0.95|-6.6|0.009
72468407|NCT00458393|144459892|SUPERIORITY||Median Difference (Net)|0.0||||1|TWO_SIDED|95.0|-9.3|9.3|||median regression|||||9.3|-9.3|1.00
72468408|NCT00458393|144459893|SUPERIORITY||Median Difference (Net)|-2.2||||0.19|TWO_SIDED|95.0|-5.5|1.1|||median regression|||||1.1|-5.5|0.19
72468409|NCT00458393|144459894|SUPERIORITY||Mean Difference (Net)|0.08||||0.56|TWO_SIDED|95.0|-0.18|0.33|||t-test, 2 sided|||||0.33|-.18|0.56
72468410|NCT00458393|144459895|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|1.0||||1|TWO_SIDED||||||Fisher Exact|||Null hypothesis is the proportion of mutations is identical.|Detailed resistance data is found at https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4176446/|||1.00
72468411|NCT00458393|144459896|SUPERIORITY||Mean Difference (Net)|-7.0||||0.32|TWO_SIDED|95.0|-69.0|54.0|||Mixed Models Analysis|||||54|-69|0.32
72468412|NCT00458393|144459897|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.005||||0.53|TWO_SIDED|95.0|-0.02|0.01|||Mixed Models Analysis|||Null hypothesis is equal proportion of pills returned||0.01|-0.02|0.53
72468413|NCT00458393|144459898|SUPERIORITY||Mean Difference (Net)|0.25||||0.7|TWO_SIDED|95.0|-1.1|1.6|||t-test, 2 sided||||Detailed methods and results are available at https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4110718/|1.6|-1.1|0.70
72468414|NCT00458393|144459899|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.99|TWO_SIDED|||||Not adjusted for multiple comparisons and the a priori threshold for statistical significance was p \< 0.05|Wilcoxon (Mann-Whitney)|||||||0.99
72468415|NCT00458393|144459900|SUPERIORITY||Median Difference (Final Values)|0.0||||0.76|TWO_SIDED|95.0|-0.42|0.42||Not adjusted for multiple comparisons, a priori threshold for statistical significance, p \< 0.05|Wilcoxon (Mann-Whitney)||||Full details available in the methods section of https://www.ncbi.nlm.nih.gov/pubmed/24367497|.42|-.42|0.76
72468416|NCT00458393|144459901|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|-0.008||||0.68|TWO_SIDED|95.0|-0.047|0.03|||Chi-squared|||Null is no difference between arms||0.030|-0.047|0.68
72468417|NCT00458393|144459902|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.13||||0.3|TWO_SIDED|95.0|0.89|1.43|||Log Rank|||Null hypothesis of no difference between the arms||1.43|0.89|0.30
72468418|NCT00458393|144459903|SUPERIORITY||Hazard Ratio (HR)|1.2||||0.41|TWO_SIDED|95.0|0.8|1.7|||Log Rank||||Details in the manuscript https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3956614/|1.7|0.8|0.41
72468419|NCT00458393|144459904|SUPERIORITY||Hazard Ratio (HR)|0.61||||0.09|TWO_SIDED|95.0|0.34|1.09|||Log Rank|||||1.09|0.34|0.09
72468420|NCT01587118|144459913|SUPERIORITY_OR_OTHER||||||<|0.0001||||||The a priori threshold for statistical significance was p\</= 0.05|ANOVA|Change from baseline analyses were conducted using simple one-way analysis of variance; and were recalculated using the Kruskal Wallis procedure.||||||<.0001
72468421|NCT01587118|144459914|SUPERIORITY_OR_OTHER|||||||0.0006||||||The a priori threshold for statistical significance was p\</= 0.05|ANOVA|Change from baseline analyses were conducted using simple one-way analysis of variance; and were recalculated using the Kruskal Wallis procedure.||||||.0006
72621933|NCT00829868|144774254|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of Geometric Means|101.0||||||90.0|97.5|106.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||106|97.5|
72621934|NCT00829868|144774255|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of Geometric Means|100.0||||||90.0|96.2|104.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||104|96.2|
72621935|NCT06091956|144774260|SUPERIORITY|||||||0.008|||||||McNemar|||||||0.008
72621936|NCT06091956|144774261|SUPERIORITY|||||||0.629|||||||Wilcoxon (Mann-Whitney)|||||||0.629
72621937|NCT06091956|144774264|SUPERIORITY|||||||0.175|||||||Wilcoxon (Mann-Whitney)|||||||0.175
72621938|NCT06091956|144774265|SUPERIORITY|||||||0.014|||||||Wilcoxon (Mann-Whitney)|||||||0.014
72621939|NCT01421459|144774282|NON_INFERIORITY_OR_EQUIVALENCE|The primary treatment comparison was to compare LY2963016 versus Lantus at the non-inferiority margin of +0.4%. If the upper limit of the 95% confidence interval on the change from baseline to 24-week endpoint HbA1c for LY2963016 versus Lantus was below +0.4%, then LY2963016 would be declared non-inferior to Lantus.|Mean Difference (Final Values)|0.052||||0.403|TWO_SIDED|95.0|-0.07|0.175|||ANCOVA|||||0.175|-0.070|0.403
72621940|NCT01421459|144774284|SUPERIORITY_OR_OTHER|||||||0.382||95.0||||P-value is for 4 weeks.|ANCOVA|||||||0.382
72621941|NCT01421459|144774284|SUPERIORITY_OR_OTHER|||||||0.91||95.0||||P-value is for 8 weeks.|ANCOVA|||||||0.910
72621942|NCT01421459|144774284|SUPERIORITY_OR_OTHER|||||||0.869||95.0||||P-value is for 12 weeks.|ANCOVA|||||||0.869
72468422|NCT00537329|144459916|SUPERIORITY_OR_OTHER||2-sided exact Clopper-Pearson (percent)|86.1||||||95.0|70.5|95.3||||||Sample size enrollment of 100 subjects was planned. Assuming an overall response rate of 75 percent (%), a 95% confidence interval (CI) for the percentage of subjects responding to treatment would have ranged from 66.3% to 83.7% allowing for 5% nonevaluability. This would have provided a level of precision considered acceptable for this Asian regional study.||95.3|70.5|
72621943|NCT01421459|144774284|SUPERIORITY_OR_OTHER|||||||0.345||95.0||||P-value is for 16 weeks.|ANCOVA|||||||0.345
72394687|NCT02989194|144295812|SUPERIORITY|Descriptive statistics. All statistical comparisons were performed using 2-sided tests at the 0.05 significance level.||||||0.158||||||All p-values are presented for informational purposes only, there were no adjustments for multiple comparisons.|Wilcoxon (Mann-Whitney)|||Percent Change from Baseline to Day 2. All null hypotheses were defined as no treatment difference.||||0.158
72394688|NCT02989194|144295812|SUPERIORITY|Descriptive statistics. All statistical comparisons were performed using 2-sided tests at the 0.05 significance level.||||||0.025||||||All p-values are presented for informational purposes only, there were no adjustments for multiple comparisons.|Wilcoxon (Mann-Whitney)|||Percent Change from Baseline to Day 3. All null hypotheses were defined as no treatment difference.||||0.025
72394689|NCT02989194|144295812|SUPERIORITY|Descriptive statistics. All statistical comparisons were performed using 2-sided tests at the 0.05 significance level.||||||0.007||||||All p-values are presented for informational purposes only, there were no adjustments for multiple comparisons.|Wilcoxon (Mann-Whitney)|||Percent Change from Baseline to Day 4. All null hypotheses were defined as no treatment difference.||||0.007
72394690|NCT02989194|144295812|SUPERIORITY|Descriptive statistics. All statistical comparisons were performed using 2-sided tests at the 0.05 significance level.||||||0.061||||||All p-values are presented for informational purposes only, there were no adjustments for multiple comparisons.|Wilcoxon (Mann-Whitney)|||Percent Change from Baseline to Day 5. All null hypotheses were defined as no treatment difference.||||0.061
72394691|NCT02989194|144295812|SUPERIORITY|Descriptive statistics. All statistical comparisons were performed using 2-sided tests at the 0.05 significance level.||||||0.107||||||All p-values are presented for informational purposes only, there were no adjustments for multiple comparisons.|Wilcoxon (Mann-Whitney)|||Percent Change from Baseline to Day 6. All null hypotheses were defined as no treatment difference.||||0.107
72394692|NCT02989194|144295812|SUPERIORITY|Descriptive statistics. All statistical comparisons were performed using 2-sided tests at the 0.05 significance level.||||||0.237||||||All p-values are presented for informational purposes only, there were no adjustments for multiple comparisons.|Wilcoxon (Mann-Whitney)|||Percent Change from Baseline to Day 7. All null hypotheses were defined as no treatment difference.||||0.237
72394693|NCT02989194|144295812|SUPERIORITY|Descriptive statistics. All statistical comparisons were performed using 2-sided tests at the 0.05 significance level.||||||0.497||||||All p-values are presented for informational purposes only, there were no adjustments for multiple comparisons.|Wilcoxon (Mann-Whitney)|||Percent Change from Baseline to Day 8. All null hypotheses were defined as no treatment difference.||||0.497
72394694|NCT02989194|144295812|SUPERIORITY|Descriptive statistics. All statistical comparisons were performed using 2-sided tests at the 0.05 significance level.||||||0.704||||||All p-values are presented for informational purposes only, there were no adjustments for multiple comparisons.|Wilcoxon (Mann-Whitney)|||Percent Change from Baseline to Day 9. All null hypotheses were defined as no treatment difference.||||0.704
72394695|NCT02989194|144295812|SUPERIORITY|Descriptive statistics. All statistical comparisons were performed using 2-sided tests at the 0.05 significance level.||||||0.585||||||All p-values are presented for informational purposes only, there were no adjustments for multiple comparisons.|Wilcoxon (Mann-Whitney)|||Percent Change from Baseline to Day 10. All null hypotheses were defined as no treatment difference.||||0.585
72394696|NCT02989194|144295823|SUPERIORITY|All statistical comparisons were performed using 2-sided tests at the 0.05 significance level.||||||0.083|||||||t-test, 2 sided|||A t-test was used to assess the difference between the VIS410 total and placebo treatment groups from nasopharyngeal swabs based on the TCID50.||||0.083
72394697|NCT02989194|144295824|SUPERIORITY|All statistical comparisons were performed using 2-sided tests at the 0.05 significance level.||||||0.169||||||All p-values are presented for informational purposes only; there were no adjustments for multiple comparisons.|t-test, 2 sided|||The null hypothesis was defined as no treatment difference.||||0.169
72394698|NCT02989194|144295825|SUPERIORITY|Descriptive Statistics. Statistical comparisons were performed using log rank test.||||||0.028||||||All p-values are presented for informational purposes only; there were no adjustments for multiple comparisons.|Log Rank|||Kaplan-Meier methods were used to calculate the median time. All null hypotheses were defined as no treatment difference.|All statistical comparisons were performed using 2-sided tests at the 0.05 significance level, unless specifically stated otherwise. All null hypotheses were defined as no treatment difference. All p-values are presented for informational purposes only; there were no adjustments for multiple comparisons.|||0.028
72394699|NCT02989194|144295827|EQUIVALENCE|Descriptive Statistics. All statistical comparisons were performed at the 0.05 significance level.||||||0.173||||||All p-values are presented for informational purposes only; there were no adjustments for multiple comparisons.|Log Rank|Kaplan-Meier methods were used to calculate the median time, 25th percentile and 75th percentile.||All null hypotheses were defined as no treatment difference.||||0.173
72394700|NCT01549860|144295828|SUPERIORITY_OR_OTHER||||||<|0.024|TWO_SIDED||||||t-test, 2 sided|||||||<0.024
72394701|NCT01549860|144295830|SUPERIORITY_OR_OTHER||||||<|0.0126|TWO_SIDED|||||The MIST+SOC subjects decreased in their reported mean pain scores and reduced from a median of 3.0 to 0.6 cm after four weeks of study treatment.|ANCOVA|||||||<0.0126
72394702|NCT01635101|144295836|OTHER||LS Mean Difference|-11.8||||0.736|TWO_SIDED|97.5|-91.0|67.3|||ANOVA|||Difference in Least Squares (LS) Means||67.3|-91.0|0.736
72394703|NCT01635101|144295836|OTHER||LS Mean Difference|1.4||||0.967|TWO_SIDED|97.5|-75.9|78.7|||ANOVA|||LS Mean Difference||78.7|-75.9|0.967
72468423|NCT00537329|144459917|SUPERIORITY_OR_OTHER||2-sided exact Clopper-Pearson (percent)|89.2||||||95.0|74.6|97.0||||||EOIT||97.0|74.6|
72468424|NCT00537329|144459917|SUPERIORITY_OR_OTHER||2-sided exact Clopper-Pearson (percent)|82.8||||||95.0|64.2|94.2||||||2 Wks post EOT||94.2|64.2|
72468425|NCT00537329|144459917|SUPERIORITY_OR_OTHER||2-sided exact Clopper-Pearson (percent)|89.5||||||95.0|66.9|98.7||||||6 Wks post EOT||98.7|66.9|
72468426|NCT00537329|144459917|SUPERIORITY_OR_OTHER||2-sided exact Clopper-Pearson (percent)|72.7||||||95.0|49.8|89.3||||||12 Wks post baseline||89.3|49.8|
72468427|NCT00537329|144459918|SUPERIORITY_OR_OTHER||2-sided exact Clopper-Pearson (percent)|97.1||||||95.0|85.1|99.9||||||EOIT: success (cure/improvement)||99.9|85.1|
72468428|NCT00537329|144459918|SUPERIORITY_OR_OTHER||2-sided exact Clopper-Pearson (percent)|94.1||||||95.0|80.3|99.3||||||EOT: success (cure/improvement)||99.3|80.3|
72468429|NCT00537329|144459918|SUPERIORITY_OR_OTHER||2-sided exact Clopper-Pearson (percent)|92.9||||||95.0|76.5|99.1||||||2 Wks post EOT: success (cure/improvement)||99.1|76.5|
72468430|NCT00537329|144459918|SUPERIORITY_OR_OTHER||2-sided exact Clopper-Pearson (percent)|94.4||||||95.0|72.7|99.9||||||6 Wks post EOT: success (cure/improvement)||99.9|72.7|
72468431|NCT00537329|144459918|SUPERIORITY_OR_OTHER||2-sided exact Clopper-Pearson (percent)|85.0||||||95.0|62.1|96.8||||||12 Wks post baseline: success (cure/improvement)||96.8|62.1|
72468432|NCT00537329|144459919|SUPERIORITY_OR_OTHER||2-sided exact Clopper-Pearson (percent)|97.3||||||95.0|85.8|99.9||||||EOIT: success (erad/presumed erad)||99.9|85.8|
72468433|NCT00537329|144459919|SUPERIORITY_OR_OTHER||2-sided exact Clopper-Pearson (percent)|97.1||||||95.0|85.1|99.9||||||EOT: success (erad/presumed erad)||99.9|85.1|
72468434|NCT00537329|144459919|SUPERIORITY_OR_OTHER||2-sided exact Clopper-Pearson (percent)|86.2||||||95.0|68.3|96.1||||||2 Wks post EOT: success (erad/presumed erad)||96.1|68.3|
72468435|NCT00537329|144459919|SUPERIORITY_OR_OTHER||2-sided exact Clopper-Pearson (percent)|94.4||||||95.0|72.7|99.9||||||6 Wks post EOT: success (erad/presumed erad)||99.9|72.7|
72468436|NCT00537329|144459919|SUPERIORITY_OR_OTHER||2-sided exact Clopper-Pearson (percent)|84.2||||||95.0|60.4|96.6||||||12 Wks post baseline: success (erad/presumed erad)||96.6|60.4|
72468437|NCT00537329|144459926|SUPERIORITY_OR_OTHER||2-sided exact Clopper-Pearson (percent)|50.0||||||95.0|1.3|98.7||||||Neutropenic status: ANC ≤ 500/cmm||98.7|1.3|
72468438|NCT00537329|144459926|SUPERIORITY_OR_OTHER||2-sided exact Clopper-Pearson (percent)|75.7||||||95.0|58.8|88.2||||||Neutropenic status: ANC \> 500/cmm||88.2|58.8|
72468439|NCT00537329|144459926|SUPERIORITY_OR_OTHER||2-sided exact Clopper-Pearson (percent)|71.4||||||95.0|41.9|91.6||||||Baseline pathogen: Candida albicans||91.6|41.9|
72468440|NCT00537329|144459926|SUPERIORITY_OR_OTHER||2-sided exact Clopper-Pearson (percent)|66.7||||||95.0|22.3|95.7||||||Baseline pathogen: Candida glabrata||95.7|22.3|
72468441|NCT00537329|144459926|SUPERIORITY_OR_OTHER||2-sided exact Clopper-Pearson (percent)|100.0||||||95.0|39.8|100.0||||||Baseline pathogen: Candida parapsilosis||100.0|39.8|
72621944|NCT01421459|144774284|SUPERIORITY_OR_OTHER|||||||0.161||95.0||||P-value is for 20 weeks.|ANCOVA|||||||0.161
72468442|NCT00537329|144459926|SUPERIORITY_OR_OTHER||2-sided exact Clopper-Pearson (percent)|100.0||||||95.0|2.5|100.0||||||Baseline pathogen: Candida rugosa||100.0|2.5|
72468443|NCT00537329|144459926|SUPERIORITY_OR_OTHER||2-sided exact Clopper-Pearson (percent)|72.2||||||95.0|46.5|90.3||||||Baseline pathogen: Candida tropicalis||90.3|46.5|
72468444|NCT00537329|144459926|SUPERIORITY_OR_OTHER||2-sided exact Clopper-Pearson (percent)|84.6||||||95.0|54.6|98.1||||||Previous surgery: Any surgery||98.1|54.6|
72468445|NCT00537329|144459926|SUPERIORITY_OR_OTHER||2-sided exact Clopper-Pearson (percent)|87.5||||||95.0|47.3|99.7||||||Previous surgery: Abdominal surgery||99.7|47.3|
72468446|NCT00537329|144459926|SUPERIORITY_OR_OTHER||2-sided exact Clopper-Pearson (percent)|58.8||||||95.0|32.9|81.6||||||Elderly: Age ≥ 65 years||81.6|32.9|
72468447|NCT00537329|144459926|SUPERIORITY_OR_OTHER||2-sided exact Clopper-Pearson (percent)|54.5||||||95.0|23.4|83.3||||||Renal insufficiency (CCC \< 30 mL/min)||83.3|23.4|
72468448|NCT00537329|144459926|SUPERIORITY_OR_OTHER||2-sided exact Clopper-Pearson (percent)|81.0||||||95.0|58.1|94.6||||||Use of Central venous catheter = Yes||94.6|58.1|
72468449|NCT00537329|144459926|SUPERIORITY_OR_OTHER||2-sided exact Clopper-Pearson (percent)|71.4||||||95.0|29.0|96.3||||||Receiving chemotherapy = Yes||96.3|29.0|
72468450|NCT01390441|144459955|NON_INFERIORITY_OR_EQUIVALENCE|PK bioequivalence was assumed if the 90% confidence interval of the geometric mean ratio for the comparison fell within the range 0.80-1.25.|Geometric mean ratio|1.0|||||TWO_SIDED|90.0|0.87|1.16|||ANOVA|||Back-transformed least squares mean and confidence interval from fixed effects model performed on natural log-transformed values containing treatment as a fixed effect and gender as a covariate.||1.16|0.87|
72468451|NCT01390441|144459957|SUPERIORITY_OR_OTHER||Percent difference|-17.2|||||TWO_SIDED|95.0|-38.6|3.6|||Miettinen-Nurminen|||The difference in percent AE incidence was determined for the treatment comparison (Part A: MK-8808 500 mg/m\^2 - Part A: MabThera 500 mg/m\^2) when \>=4 participants in an arm experienced an event.||3.6|-38.6|
72621945|NCT01421459|144774284|SUPERIORITY_OR_OTHER|||||||0.097||95.0||||P-value is for 24 weeks.|ANCOVA|||||||0.097
72468452|NCT01390441|144459957|SUPERIORITY_OR_OTHER||Percent difference|-17.5|||||TWO_SIDED|95.0|-44.4|10.9|||Miettinen-Nurminen|||The difference in percent AE incidence was determined for the treatment comparison (Part B: MK-8808 1000 mg - Part B: MabThera 1000 mg) when \>=4 participants in an arm experienced an event.||10.9|-44.4|
72468453|NCT01390441|144459957|SUPERIORITY_OR_OTHER||Percent difference|-5.6|||||TWO_SIDED|95.0|-34.9|24.6|||Miettinen-Nurminen|||The difference in percent AE incidence was determined for the treatment comparison (Part B: MK-8808 1000 mg - Part B: Rituxan® 1000 mg) when \>=4 participants in an arm experienced an event.||24.6|-34.9|
72468454|NCT01390441|144459957|SUPERIORITY_OR_OTHER||Percent differnce|12.0|||||TWO_SIDED|95.0|-15.6|38.9|||Miettinen-Nurminen|||The difference in percent AE incidence was determined for the treatment comparison (Part B: MabThera® 1000 mg - Part B: Rituxan® 1000 mg) when \>=4 participants in an arm experienced an event.||38.9|-15.6|
72468455|NCT01390441|144459959|NON_INFERIORITY_OR_EQUIVALENCE|PK bioequivalence was assumed if the 90% confidence interval of the geometric mean ratio for the comparison fell within the range 0.80-1.25.|Geometric mean ratio|0.98|||||TWO_SIDED|90.0|0.87|1.1|||ANOVA|||Back-transformed least squares mean and confidence interval from fixed effects model performed on natural log-transformed values containing treatment as a fixed effect and gender as a covariate.||1.1|0.87|
72468456|NCT01390441|144459963|NON_INFERIORITY_OR_EQUIVALENCE||Mean Difference (Final Values)|-0.2|||||TWO_SIDED|95.0|-0.9|0.5|||ANCOVA|The model included a term for treatment.||Estimated difference vs MabThera® at 6 weeks.||0.5|-0.9|
72468457|NCT01390441|144459963|NON_INFERIORITY_OR_EQUIVALENCE||Mean Difference (Final Values)|0.4|||||TWO_SIDED|95.0|-0.4|1.2|||ANCOVA|The model included a term for treatment.||Estimated difference vs MabThera® at 12 weeks.||1.2|-0.4|
72468458|NCT03432390|144460002|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||t-test, 2 sided|||||||<0.0001
72621946|NCT01421459|144774285|SUPERIORITY_OR_OTHER|||||||0.837||95.0||||P-value is at Morning Pre-Meal at Baseline.|ANCOVA|||||||0.837
72621947|NCT01421459|144774285|SUPERIORITY_OR_OTHER|||||||0.62||95.0||||P-value is for Morning 2 hrs PP Meal at Baseline.|ANCOVA|||||||0.620
72394704|NCT01327885|144295846|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.768|||=|0.0169|TWO_SIDED|95.0|0.618|0.954||The P-value was calculated by 2-sided log-rank test as stratified by histology, geographic region, and number of prior regimens for advanced STS.|Log Rank||The Hazard Ratio is based on a stratified Cox regression model including treatment as covariate, and histology, geographic region, and number of prior regimens for advanced STS as strata.|Statistical analysis was designed to detect superiority of Arm A (eribulin) over Arm B (dacarbazine). OS was compared between the two treatment arms using a two-sided stratified log-rank test at a nominal significance level of 0.0455 (adjusted for the interim analysis). This was the primary analysis that was performed when the target number of events (\~353 deaths) was observed.||0.954|0.618|=0.0169
72468459|NCT01185171|144460077|NON_INFERIORITY|The power of the study was conducted as a two-stage, non-inferiority phase II trial with a total sample size of 59 patients to detect a 15% lower rate than 80% achieved with TFHX, with alpha = 0.05 and beta = 0.20. In the first stage, 25 patients were recruited, with a plan to terminate if 16 or less complete responses (CR) were observed. Otherwise, additional 34 patients would be recruited and the treatment would be deemed not inferior to historical if more than 45 CRs were observed.|proportion|0.88|||<|0.01|TWO_SIDED|95.0|0.77|0.95||Ho: CR rate = 0.65 vs Ha: CR rate \> 0.65|Binomial test for a proportion|||||0.95|0.77|< 0.01
72468460|NCT00727506|144460082|SUPERIORITY_OR_OTHER|||||||0.148||95.0||||P-value is from an approximate normal test for the 6 month time point.|z-test|||||||0.148
72468461|NCT00727506|144460082|SUPERIORITY_OR_OTHER|||||||0.008||95.0||||P-value is an approximate normal test for the six month time point.|z-test|||||||0.008
72468462|NCT00727506|144460084|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|||||||1.0000
72468463|NCT00727506|144460084|SUPERIORITY_OR_OTHER|||||||0.1954||95.0|||||Fisher Exact|||||||0.1954
72468464|NCT00727506|144460085|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.78||||0.032|TWO_SIDED|95.0|1.088|2.912|||Log Rank|||Hazard ratio was calculated from Cox proportional hazard model stratified by age class (\<=50 vs. \>50 years old) and baseline Karnofsky Performance Scale (KPS) score (70, 80 vs. 90, 100). P-value was two-sided from log-rank test stratified by the same variables.||2.912|1.088|0.0320
72468465|NCT00727506|144460085|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.392||||0.2044|TWO_SIDED|95.0|0.841|2.301|||Log Rank|||Hazard ratio was calculated from Cox proportional hazard model stratified by age class (\<=50 vs. \>50 years old) and baseline KPS score (70, 80 vs. 90, 100). P-value was two-sided from log-rank test stratified by the same variables.||2.301|0.841|0.2044
72468466|NCT02647645|144460234|SUPERIORITY|Power calculation was based on similar studies of cognitive training with transcranial direct current stimulation (tDCS).||||||0.02||||||Probability associated with the test of the interaction between participants' performance and session number in repeated measures analysis of covariance. In light of small sample size, estimated effect size was also calculated (d = 1.78).|ANCOVA|Test was adjusted for age, gender, race, education, CD4 count, and log viral load.||Analysis results are overall estimated marginal means from repeated measures analysis of covariance with treatment group as a fixed factor and age, gender, race, education, cluster of differentiation (CD4) cell count, and log viral load as covariates.||||0.02
72468467|NCT02647645|144460235|SUPERIORITY|Power calculation was based on similar studies of cognitive training with transcranial direct current stimulation (tDCS).||||||0.34||||||Probability associated with the test of the interaction between participants' performance and session number in repeated measures analysis of covariance. In light of small sample size, estimated effect size was also calculated (d = .71).|ANCOVA|Test was adjusted for age, gender, race, education, CD4 count, and log viral load.||Results are overall estimated marginal means from repeated measures analysis of covariance with treatment group as a fixed factor and age, gender, race, education, CD4 count, and log viral load as covariates.||||0.34
72468468|NCT02647645|144460236|SUPERIORITY|Power calculation was based on the investigators' estimate of the impact of cognitive training with transcranial direct current stimulation (tDCS) on subjective cognitive problems, as similar studies were not available to develop effect size estimates.||||||0.33||||||Probability associated with the test of the interaction between participants' performance and session number in repeated measures analysis of covariance. In light of small sample size, estimated effect size was also calculated (d = .63).|ANCOVA|Test was adjusted for age, gender, race, education, CD4 count, and log viral load.||Results are overall estimated marginal means from repeated measures analysis of covariance with treatment group as a fixed factor and age, gender, race, education, CD4 count, and log viral load as covariates.||||0.33
72468469|NCT00356811|144460237|SUPERIORITY_OR_OTHER||percentage of participants|50.9|||||TWO_SIDED|95.0|37.3|64.4|||||The estimated value represents the percentage of participants with a confirmed CR or PR.|||64.4|37.3|
72621948|NCT01421459|144774285|SUPERIORITY_OR_OTHER|||||||0.107||95.0||||P-value is for Midday Pre-Meal at Baseline|ANCOVA|||||||0.107
72621949|NCT01421459|144774285|SUPERIORITY_OR_OTHER|||||||0.258||95.0||||P-value is for Midday 2 hrs PP Meal at Baseline.|ANCOVA|||||||0.258
72621950|NCT01421459|144774285|SUPERIORITY_OR_OTHER|||||||0.161||95.0||||P-value is for Evening Pre-Meal at Baseline.|ANCOVA|||||||0.161
72621951|NCT01421459|144774285|SUPERIORITY_OR_OTHER|||||||0.725||95.0||||P-value is for Bed Time at Baseline.|ANCOVA|||||||0.725
72468470|NCT02825251|144460325|NON_INFERIORITY|Non-inferiority of faster aspart was considered confirmed if the upper limit of the two-sided 95 % CI for the true treatment-difference D (faster aspart minus NovoRapid®) was below 0.4 %.|Treatment difference|0.09|||||TWO_SIDED|95.0|0.01|0.17|||ANOVA|||Change from baseline in HbA1c was analysed using an analysis of variance model after multiple imputation assuming treatment according to randomisation. The model included treatment, strata (use of own continuous glucose monitoring), previous insulin use, and region as factors, and baseline HbA1c as a covariate.||0.17|0.01|
72468471|NCT02820597|144460421|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|Paired t-tests on the mean change from baseline. No adjustments were made for multiple comparisons.||Null hypothesis is that the within-participant change from baseline in rTNSS is 0.||||<0.001
72468472|NCT02820597|144460422|SUPERIORITY||||||<|0.001||||||Paired t-tests on the mean change from baseline. No adjustments were made for multiple comparisons.|t-test, 2 sided|||Null hypothesis is that the within-participant change from baseline in rhinitis symptoms VAS is 0.||||<0.001
72468473|NCT00575042|144460425|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon (Mann-Whitney)|||Sample size calculation estimated that with 20 patients, and assuming a 10% drop-out rate, the study would have 80% power to detect a response rate in 35% or more of the study patients. A two-sided p value\<0.05 was considered statistically significant.||||<0.0001
72565010|NCT00562120|144661733|SUPERIORITY_OR_OTHER|||||||0.816|TWO_SIDED|||||P-value was based on two-sided test which was underpowered and presented for descriptive purposes only. There were no further adjustments for multiplicity.|ANOVA|||An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||||0.816
72565011|NCT00562120|144661734|SUPERIORITY_OR_OTHER|||||||0.269|TWO_SIDED|||||P-value was based on a one-sided test. There were no further adjustments for multiplicity.|ANOVA|||An analysis of variance (ANOVA) mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||||0.269
72565012|NCT00562120|144661734|SUPERIORITY_OR_OTHER|||||||0.097|TWO_SIDED|||||P-value was based on a one-sided test. There were no further adjustments for multiplicity.|ANOVA|||An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||||0.097
72565013|NCT00562120|144661734|SUPERIORITY_OR_OTHER|||||||0.252|TWO_SIDED|||||P-value was based on a one-sided test. There were no further adjustments for multiplicity.|ANOVA|||An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||||0.252
72565014|NCT00562120|144661734|SUPERIORITY_OR_OTHER|||||||0.479|TWO_SIDED|||||P-value was based on two-sided test which was underpowered and presented for descriptive purposes only. There were no further adjustments for multiplicity.|ANOVA|||An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||||0.479
72565015|NCT00562120|144661734|SUPERIORITY_OR_OTHER|||||||0.521|TWO_SIDED|||||P-value was based on two-sided test which was underpowered and presented for descriptive purposes only. There were no further adjustments for multiplicity.|ANOVA|||An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||||0.521
72621952|NCT01421459|144774285|SUPERIORITY_OR_OTHER|||||||0.543||95.0||||P-value is for 0300 hrs at Baseline.|ANCOVA|||||||0.543
72621953|NCT01421459|144774285|SUPERIORITY_OR_OTHER|||||||0.265||95.0||||P-value is for Morning Pre-Meal at Endpoint, up to 24 wk.|ANCOVA|||||||0.265
72394705|NCT01327885|144295847|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.877|||=|0.2287|TWO_SIDED|95.0|0.71|1.085||P-value was calculated by 2-sided log-rank test, as stratified by histology, geographic region, and number of prior regimens for advanced STS.|Log Rank||The Hazard Ratio is based on a stratified Cox regression model including treatment as covariate, and histology, geographic region, and number of prior regimens for advanced STS as strata.|The PFS and PFS rate at 3, 6, and 12 months (95% confidence interval (CI)) was calculated using Kaplan-Meier (K-M) product-limit method and Greenwood Formula. PFS was compared between the treatment arms using two-sided stratified log-rank test, stratified by histology, geographic region, and number of prior regimens for advanced STS.||1.085|0.710|=0.2287
72468474|NCT02007200|144460446|SUPERIORITY_OR_OTHER||||||<|0.005|||||||Linear Repeated Measures Model|||||||<0.005
72468475|NCT04182113|144460454|SUPERIORITY||Mean Difference (Net)|-0.042||||0.32|TWO_SIDED|95.0|-0.129|0.044||Not adjusted for multiple comparisons.|t-test, 2 sided|||Paired t-test comparing Target vs. Foil activity following 1Hz rTMS to Target vs. Foil activity following 20 Hz rTMS stimulation.||0.044|-0.129|0.32
72621954|NCT01421459|144774285|SUPERIORITY_OR_OTHER|||||||0.05||95.0||||P-value is for Morning 2 hrs PP Meal at Endpoint, up to 24 weeks.|ANCOVA|||||||0.050
72621955|NCT01421459|144774285|SUPERIORITY_OR_OTHER|||||||0.04||95.0||||P-value is for Midday Pre-Meal at Endpoint, up to 24 weeks.|ANCOVA|||||||0.040
72621956|NCT01421459|144774285|SUPERIORITY_OR_OTHER|||||||0.366||95.0||||P-value is for Midday 2 hrs PP Meal at Endpoint, up to 24 weeks.|ANCOVA|||||||0.366
72621957|NCT01421459|144774285|SUPERIORITY_OR_OTHER|||||||0.485||95.0||||P-value is for Evening Pre-Meal at Endpoint, up to 24 weeks.|ANCOVA|||||||0.485
72621958|NCT01421459|144774285|SUPERIORITY_OR_OTHER|||||||0.537||95.0||||P-value is for Bed Time at Endpoint, up to 24 weeks.|ANCOVA|||||||0.537
72621959|NCT01421459|144774285|SUPERIORITY_OR_OTHER|||||||0.878||95.0||||P-value is for 0300 hrs at Endpoint, up to 24 weeks.|ANCOVA|||||||0.878
72468476|NCT04182113|144460454|SUPERIORITY||Mean Difference (Net)|0.043||||0.25|TWO_SIDED|95.0|-0.03|0.12||Not adjusted for multiple comparisons.|t-test, 2 sided|||Paired t-test between Target vs. Foil activation following 1 Hz rTMS and Target vs. Foil activation following Sham stimulation..||0.12|-0.03|0.25
72621960|NCT01421459|144774286|SUPERIORITY_OR_OTHER|||||||0.779||95.0||||P-value is for Baseline.|ANCOVA|||||||0.779
72621961|NCT01421459|144774286|SUPERIORITY_OR_OTHER|||||||0.788||95.0||||P-value is for Endpoint, up to 24 weeks.|ANCOVA|||||||0.788
72468477|NCT04182113|144460454|SUPERIORITY||Mean Difference (Net)|0.078||||0.13|TWO_SIDED|95.0|-0.024|0.181||Not adjusted for multiple comparisons.|t-test, 2 sided|||Paired t-test between Target vs. Foil activity following 20 Hz rTMS and Target vs. Foil activity following Sham stimulation.||0.181|-0.024|0.13
72565016|NCT00562120|144661734|SUPERIORITY_OR_OTHER|||||||0.952|TWO_SIDED|||||P-value was based on two-sided test which was underpowered and presented for descriptive purposes only. There were no further adjustments for multiplicity.|ANOVA|||An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||||0.952
72565017|NCT00562120|144661735|SUPERIORITY_OR_OTHER|||||||0.13|TWO_SIDED|||||P-value was based on a one-sided test. There were no further adjustments for multiplicity.|ANOVA|||An analysis of variance (ANOVA) mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||||0.130
72565018|NCT00562120|144661735|SUPERIORITY_OR_OTHER|||||||0.663|TWO_SIDED|||||P-value was based on a one-sided test. There were no further adjustments for multiplicity.|ANOVA|||An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||||0.663
72565019|NCT00562120|144661735|SUPERIORITY_OR_OTHER|||||||0.138|TWO_SIDED|||||P-value was based on a one-sided test. There were no further adjustments for multiplicity.|ANOVA|||An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||||0.138
72565020|NCT00562120|144661735|SUPERIORITY_OR_OTHER|||||||0.124|TWO_SIDED|||||P-value was based on two-sided test which was underpowered and presented for descriptive purposes only. There were no further adjustments for multiplicity.|ANOVA|||An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||||0.124
72621962|NCT01421459|144774287|SUPERIORITY_OR_OTHER|||||||0.687||95.0||||P-value is for Baseline.|ANCOVA|||||||0.687
72468478|NCT04182113|144460455|SUPERIORITY||Mean Difference (Net)|0.018||||0.038|TWO_SIDED|95.0|0.001|0.034||Not corrected for multiple comparisons.|t-test, 2 sided|||Paired t-test comparing precuneus connectivity following 1Hz rTMS to precuneus connectivity following 20 Hz rTMS stimulation.||0.034|0.001|0.038
72468479|NCT04182113|144460455|SUPERIORITY||Mean Difference (Net)|0.009||||0.44|TWO_SIDED|95.0|-0.015|0.033|||t-test, 2 sided|||Paired t-test comparing precuneus connectivity following 1Hz rTMS to precuneus connectivity following 20 Hz rTMS stimulation.||0.033|-0.015|0.44
72468480|NCT04182113|144460455|SUPERIORITY||Mean Difference (Net)|-0.012||||0.25|TWO_SIDED|95.0|-0.032|0.009|||t-test, 2 sided|||Paired t-test comparing precuneus connectivity following 20Hz rTMS to precuneus connectivity following sham stimulation.||0.009|-0.032|0.25
72468481|NCT04182113|144460456|SUPERIORITY||Mean Difference (Net)|2.7||||0.2|TWO_SIDED|95.0|-1.6|6.9||Not adjusted for multiple comparisons.|t-test, 2 sided|||Paired t-test of scene recognition performance accuracy following 1Hz rTMS to accuracy following 20 Hz rTMS.||6.9|-1.6|0.20
72468482|NCT04182113|144460456|SUPERIORITY||Mean Difference (Net)|4.0||||0.17|TWO_SIDED|95.0|-1.9|9.9||Not corrected for multiple comparisons.|t-test, 2 sided|||Paired t-test of scene recognition performance accuracy following 1Hz rTMS to accuracy following sham rTMS.||9.9|-1.9|0.17
72468483|NCT04182113|144460456|SUPERIORITY||Mean Difference (Net)|-1.3||||0.77|TWO_SIDED|95.0|-10.8|8.2||Not adjusted for multiple comparisons.|t-test, 2 sided|||Paired t-test of scene recognition performance accuracy following 20Hz rTMS to accuracy following 20 Hz rTMS.||8.2|-10.8|0.77
72468484|NCT01667406|144460457|OTHER|Fishers exact conditional test was used to confirm significance|Mean Difference (Final Values)|6.0|||||ONE_SIDED|95.0||||||||Data presented using descriptive statistics. Confidence intervals were derived for the difference between the means of different doses.||||
72468485|NCT01667406|144460457|OTHER||||||<|0.05|||||||Fisher Exact|||Phase 2||||<0.05
72468486|NCT01667406|144460457|OTHER||Odds Ratio (OR)|0.05|||<|0.05|ONE_SIDED|95.0|||||Regression, Logistic||Estimate of difference in success rates and estimate of odds ratio for success were derived, with P value comparing 2 treatment groups, 95% conﬁdence intervals.|Phase 3||||<0.05
72468487|NCT01667406|144460458|OTHER|secondary outcomes were analysed using descriptive statistics.||||||||||||||||Study data were summarised using standard descriptive methods. Continuous variables following a normal distribution have been summarised using mean and SD.|secondary outcomes were analysed using descriptive statistics.|||
72468488|NCT02229578|144460463|SUPERIORITY||Mean Difference (Final Values)|0.45|||<|0.05|TWO_SIDED|95.0|-1.2|2.1|||t-test, 2 sided|||Outcome was residual change score calculated by regressing immediate postop pain on 24 hour pain. This allows patient to serve as own control for intial values.||2.1|-1.2|<0.05
72468489|NCT02229578|144460464|SUPERIORITY||Mean Difference (Final Values)|-0.14|STANDARD_ERROR_OF_MEAN|0.79|<|0.05|TWO_SIDED|95.0|-1.77|1.49|||t-test, 2 sided|||Outcome was residual change score calculated by regressing immediate postop pain on 24 hour pain. This allows patient to serve as own control for intial values.||1.49|-1.77|<0.05
72468490|NCT02229578|144460465|SUPERIORITY||Mean Difference (Final Values)|-1.76|STANDARD_ERROR_OF_MEAN|3.61|<|0.05|TWO_SIDED|95.0|-9.62|6.09|||t-test, 2 sided|||Outcome was residual change score calculated by regressing immediate postop hydromorphone on 24 hour hydromorphone. This allows patient to serve as own control for intial values.||6.09|-9.62|<0.05
72504148|NCT01025336|144539190|SUPERIORITY_OR_OTHER||geometric mean fold rise|4.7|||||TWO_SIDED|95.0|3.52|6.29|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 23F: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||6.29|3.52|
72565021|NCT00562120|144661735|SUPERIORITY_OR_OTHER|||||||0.134|TWO_SIDED|||||P-value was based on two-sided test which was underpowered and presented for descriptive purposes only. There were no further adjustments for multiplicity.|ANOVA|||An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||||0.134
72468491|NCT02706951|144460472|SUPERIORITY|The overall type I error prevalence of the primary and ranked key secondary endpoints for the two doses of upadacitinib were strongly controlled by means of a graphic multiple testing procedure.|Response Rate Difference|26.5|||<|0.001|TWO_SIDED|95.0|17.5|35.6||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratification factor geographic region.|Response Rate Difference = Upadacitinib - Methotrexate|||35.6|17.5|<0.001
72468492|NCT02706951|144460472|SUPERIORITY|The overall type I error prevalence of the primary and ranked key secondary endpoints for the two doses of upadacitinib were strongly controlled by means of a graphic multiple testing procedure.|Response Rate Difference|30.0|||<|0.001|TWO_SIDED|95.0|21.0|38.9||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratification factor geographic region.|Response Rate Difference = Upadacitinib - Methotrexate|||38.9|21.0|<0.001
72621963|NCT01421459|144774287|SUPERIORITY_OR_OTHER|||||||0.036||95.0||||P-value is for change at 4 wks.|ANCOVA|||||||0.036
72468493|NCT02706951|144460473|SUPERIORITY|The overall type I error prevalence of the primary and ranked key secondary endpoints for the two doses of upadacitinib were strongly controlled by means of a graphic multiple testing procedure.|Response Rate Difference|25.3|||<|0.001|TWO_SIDED|95.0|16.8|33.7||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratification factor geographic region.|Response Rate Difference = Upadacitinib - Methotrexate|||33.7|16.8|<0.001
72504149|NCT01025336|144539191|SUPERIORITY_OR_OTHER||geometric mean fold rise|3.7|||||TWO_SIDED|95.0|3.05|4.49|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 1: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||4.49|3.05|
72504150|NCT01025336|144539191|SUPERIORITY_OR_OTHER||geometric mean fold rise|2.3|||||TWO_SIDED|95.0|1.92|2.81|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 1: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||2.81|1.92|
72621964|NCT01421459|144774287|SUPERIORITY_OR_OTHER|||||||0.323||95.0||||P-value is for change at 8 wks.|ANCOVA|||||||0.323
72394706|NCT01327885|144295848|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.3||||0.253|TWO_SIDED|95.0|0.8|1.9||The P-value was calculated using the stratified CMH method, the stratified factors included histology, geographic region, and number of prior regimens for advanced STS.|Cochran-Mantel-Haenszel||The odds ratio between eribulin and dacarbazine was calculated by stratified CMH method. The stratified factors were as described above. The 2-sided 95% CI of the odds ratio is based on asymptotic normal approximation.|The PFR12wks was compared between the treatment arms using stratified Cochran-Mantel-Haenszel (CMH) chi-square test stratified by histology, geographic region, and number of prior regimens for advanced STS.||1.9|0.8|0.253
72394707|NCT01327885|144295849|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.9|||=|0.741|TWO_SIDED|95.0|0.7|1.4||The P-value was calculated using the CMH method. The stratified factors were histology, geographic region, and number of prior regimens for advanced STS.|Cochran-Mantel-Haenszel||The Odds Ratio between eribulin and dacarbazine was calculated by stratified CMH method. The stratified factors were as described above. The 2-sided 95% CI of Odds Ratio is based on asymptotic normal approximation.|The PFR12wks was compared between the treatment arms using stratified CMH chi-square test stratified by histology, geographic region, and number of prior regimens for advanced STS.||1.4|0.7|=0.741
72394708|NCT03232801|144295850|SUPERIORITY||chi-squared|4.86||||0.027|TWO_SIDED||||||Chi-squared|||||||0.027
72394709|NCT03232801|144295851|SUPERIORITY||chi-squared|0.45||||0.503|TWO_SIDED||||||Chi-squared|||||||0.503
72394710|NCT03395886|144295903|OTHER|||||||0.831|||||||Chi-squared|||Summary statistics are expressed as numbers and percentages and compared between groups by Chi-square test.||||0.831
72394711|NCT03395886|144295904|OTHER|||||||0.8|||||||Generalized estimating equations|||||||0.800
72394712|NCT01170754|144295920|NON_INFERIORITY|Inferiority between the two groups was defined as a difference of 10% in the overall BBPS score||||||0.45|TWO_SIDED|95.0||||p\<.05 was defined as the a priori threshold for statistical significance|t-test, 2 sided|||||||.45
72565022|NCT00562120|144661735|SUPERIORITY_OR_OTHER|||||||0.978|TWO_SIDED|||||P-value was based on two-sided test which was underpowered and presented for descriptive purposes only. There were no further adjustments for multiplicity.|ANOVA|||An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||||0.978
72565023|NCT00562120|144661736|SUPERIORITY_OR_OTHER|||||||0.357|TWO_SIDED|||||P-value was based on a one-sided test. There were no further adjustments for multiplicity.|ANOVA|||An analysis of variance (ANOVA) mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||||0.357
72394713|NCT01170754|144295921|EQUIVALENCE|Equivalence between the two groups was defined as a p-value = or \>.05.||||||0.13|TWO_SIDED|95.0||||p\<.05 was defined as the a priori threshold for statistical significance|t-test, 2 sided|||||||.13
72394714|NCT01170754|144295922|EQUIVALENCE|Equivalence between the two groups was defined as a p-value = or \>.05.||||||0.31|TWO_SIDED|95.0||||p\<.05 was defined as the a priori threshold for statistical significance|t-test, 2 sided|||||||.31
72394715|NCT01170754|144295923|EQUIVALENCE|Equivalence between the two groups was defined as a p-value = or \>.05.||||||0.87|TWO_SIDED|95.0||||p\<.05 was defined as the a priori threshold for statistical significance|t-test, 2 sided|||||||.87
72394716|NCT01170754|144295924|EQUIVALENCE|Equivalence between the two groups was defined as a p-value = or \>.05.||||||0.25|TWO_SIDED|95.0||||p\<.05 was defined as the a priori threshold for statistical significance|t-test, 2 sided|||||||.25
72394717|NCT01170754|144295925|EQUIVALENCE|Equivalence between the two groups was defined as a p-value = or \>.05.||||||0.47|TWO_SIDED|95.0||||p\<.05 was defined as the a priori threshold for statistical significance|t-test, 2 sided|||||||.47
72394718|NCT01170754|144295926|EQUIVALENCE|Equivalence between the two groups was defined as a p-value = or \>.05.||||||0.34|TWO_SIDED|95.0|||||t-test, 2 sided|||||||.34
72394719|NCT01170754|144295927|EQUIVALENCE|Equivalence between the two groups was defined as a p-value = or \>.05.||||||0.18|TWO_SIDED|95.0||||p\<.05 was defined as the a priori threshold for statistical significance|t-test, 2 sided|||||||.18
72504151|NCT01025336|144539191|SUPERIORITY_OR_OTHER||geometric mean fold rise|2.1|||||TWO_SIDED|95.0|1.83|2.5|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 3: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||2.50|1.83|
72504152|NCT01025336|144539191|SUPERIORITY_OR_OTHER||geometric mean fold rise|1.5|||||TWO_SIDED|95.0|1.32|1.74|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 3: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||1.74|1.32|
72565024|NCT00562120|144661736|SUPERIORITY_OR_OTHER|||||||0.952|TWO_SIDED|||||P-value was based on a one-sided test. There were no further adjustments for multiplicity.|ANOVA|||An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||||0.952
72565025|NCT00562120|144661736|SUPERIORITY_OR_OTHER|||||||0.48|TWO_SIDED|||||P-value was based on a one-sided test. There were no further adjustments for multiplicity.|ANOVA|||An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||||0.480
72565026|NCT00562120|144661736|SUPERIORITY_OR_OTHER|||||||0.043|TWO_SIDED|||||P-value was based on two-sided test which was underpowered and presented for descriptive purposes only. There were no further adjustments for multiplicity.|ANOVA|||An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||||0.043
72621965|NCT01421459|144774287|SUPERIORITY_OR_OTHER|||||||0.368||95.0||||P-value is for change at 12 wks.|ANCOVA|||||||0.368
72621966|NCT01421459|144774287|SUPERIORITY_OR_OTHER|||||||0.089||95.0||||P-value is for change at 16 wks.|ANCOVA|||||||0.089
72621967|NCT01421459|144774287|SUPERIORITY_OR_OTHER|||||||0.041||95.0||||P-value is for change at 20 wks.|ANCOVA|||||||0.041
72621968|NCT01421459|144774287|SUPERIORITY_OR_OTHER|||||||0.33||95.0||||P-value is for change at 24 wks.|ANCOVA|||||||0.330
72621969|NCT01421459|144774287|SUPERIORITY_OR_OTHER|||||||0.334||95.0||||P-value is for change at Endpoint, up to 24 wks.|ANCOVA|||||||0.334
72621970|NCT01421459|144774288|SUPERIORITY_OR_OTHER|||||||0.726||95.0||||P-value is for Behavior domain at 4 weeks.|ANCOVA|||||||0.726
72621971|NCT01421459|144774288|SUPERIORITY_OR_OTHER|||||||0.502||95.0||||P-value is for Behavior domain at 12 weeks.|ANCOVA|||||||0.502
72468494|NCT02706951|144460473|SUPERIORITY|The overall type I error prevalence of the primary and ranked key secondary endpoints for the two doses of upadacitinib were strongly controlled by means of a graphic multiple testing procedure.|Response Rate Difference|33.6|||<|0.001|TWO_SIDED|95.0|25.1|42.1||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratification factor geographic region.|Response Rate Difference = Upadacitinib - Methotrexate|||42.1|25.1|<0.001
72468495|NCT02706951|144460474|SUPERIORITY|The overall type I error prevalence of the primary and ranked key secondary endpoints for the two doses of upadacitinib were strongly controlled by means of a graphic multiple testing procedure.|Least Squares (LS) Mean Difference|-1.08|||<|0.001|TWO_SIDED|95.0|-1.32|-0.85||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|ANCOVA|Analysis of covariance (ANCOVA) model with treatment as the fixed factor, and baseline value and geographic region as the covariates.|Difference = Upadacitinib - Methotrexate|||-0.85|-1.32|<0.001
72468496|NCT02706951|144460474|SUPERIORITY|The overall type I error prevalence of the primary and ranked key secondary endpoints for the two doses of upadacitinib were strongly controlled by means of a graphic multiple testing procedure.|LS Mean Difference|-1.4|||<|0.001|TWO_SIDED|95.0|-1.64|-1.17||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|ANCOVA|ANCOVA model with treatment as the fixed factor, and baseline value and the stratification factor geographic region as the covariates.|Difference = Upadacitinib - Methotrexate|||-1.17|-1.64|<0.001
72468497|NCT02706951|144460475|SUPERIORITY|The overall type I error prevalence of the primary and ranked key secondary endpoints for the two doses of upadacitinib were strongly controlled by means of a graphic multiple testing procedure.|LS Mean Difference|-0.33|||<|0.001|TWO_SIDED|95.0|-0.43|-0.22||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|ANCOVA|ANCOVA model with treatment as the fixed factor, and baseline value and the stratification factor geographic region as the covariates.|Difference = Upadacitinib - Methotrexate|||-0.22|-0.43|<0.001
72468498|NCT02706951|144460475|SUPERIORITY|The overall type I error prevalence of the primary and ranked key secondary endpoints for the two doses of upadacitinib were strongly controlled by means of a graphic multiple testing procedure.|LS Mean Difference|-0.41|||<|0.001|TWO_SIDED|95.0|-0.51|-0.3||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|ANCOVA|ANCOVA model with treatment as the fixed factor, and baseline value and the stratification factor geographic region as the covariates.|Difference = Upadacitinib - Methotrexate|||-0.30|-0.51|<0.001
72468499|NCT02706951|144460476|SUPERIORITY|The overall type I error prevalence of the primary and ranked key secondary endpoints for the two doses of upadacitinib were strongly controlled by means of a graphic multiple testing procedure.|LS Mean Difference|3.97|||<|0.001|TWO_SIDED|95.0|2.52|5.42||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|Mixed Effect Model Repeat Measurement|MMRM model with fixed effects of treatment, visit, treatment-by-visit interaction, and geographic region, and the baseline value as covariate.|Difference = Upadacitinib - Methotrexate|||5.42|2.52|<0.001
72468500|NCT02706951|144460476|SUPERIORITY|The overall type I error prevalence of the primary and ranked key secondary endpoints for the two doses of upadacitinib were strongly controlled by means of a graphic multiple testing procedure.|LS Mean Difference|5.87|||<|0.001|TWO_SIDED|95.0|4.42|7.32||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|Mixed Effect Model Repeat Measurement|MMRM model with fixed effects of treatment, visit, treatment-by-visit interaction, and geographic region, and the baseline value as covariate.|Difference = Upadacitinib - Methotrexate|||7.32|4.42|<0.001
72468501|NCT02706951|144460477|SUPERIORITY|The overall type I error prevalence of the primary and ranked key secondary endpoints for the two doses of upadacitinib were strongly controlled by means of a graphic multiple testing procedure.|Response Rate Difference|19.8|||<|0.001|TWO_SIDED|95.0|12.8|26.8||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratification factor geographic region.|Response Rate Difference = Upadacitinib - Methotrexate|||26.8|12.8|<0.001
72468502|NCT02706951|144460477|SUPERIORITY|The overall type I error prevalence of the primary and ranked key secondary endpoints for the two doses of upadacitinib were strongly controlled by means of a graphic multiple testing procedure.|Response Rate Difference|32.1|||<|0.001|TWO_SIDED|95.0|24.6|39.7||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratification factor geographic region.|Response Rate Difference = Upadacitinib - Methotrexate|||39.7|24.6|<0.001
72468503|NCT02706951|144460478|SUPERIORITY|The overall type I error prevalence of the primary and ranked key secondary endpoints for the two doses of upadacitinib were strongly controlled by means of a graphic multiple testing procedure.|LS Mean Difference|-41.53||||0.001|TWO_SIDED|95.0|-66.56|-16.5||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|Mixed Effect Model Repeat Measurement|MMRM model with fixed effects of treatment, visit, treatment-by-visit interaction, and geographic region, and the baseline value as covariate.|Difference = Upadacitinib - Methotrexate|||-16.50|-66.56|0.001
72468504|NCT02706951|144460478|SUPERIORITY|The overall type I error prevalence of the primary and ranked key secondary endpoints for the two doses of upadacitinib were strongly controlled by means of a graphic multiple testing procedure.|LS Mean Difference|-49.31|||<|0.001|TWO_SIDED|95.0|-74.23|-24.4||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|Mixed Effect Model Repeat Measurement|MMRM model with fixed effects of treatment, visit, treatment-by-visit interaction, and geographic region, and the baseline value as covariate.|Difference = Upadacitinib - Methotrexate|||-24.40|-74.23|<0.001
72468505|NCT02706951|144460479|SUPERIORITY||Response Rate Difference|26.7|||<|0.001|TWO_SIDED|95.0|18.5|34.8||This comparison was not part of the pre-specified multiplicity testing sequence; the nominal p-value is reported.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratification factor geographic region.|Response Rate Difference = Upadacitinib - Methotrexate|||34.8|18.5|<0.001
72394720|NCT01170754|144295928|EQUIVALENCE|Equivalence between the two groups was defined as a p-value = or \>.05.||||||0.75|TWO_SIDED|95.0||||p\<.05 was defined as the a priori threshold for statistical significance|t-test, 2 sided|||||||.75
72468506|NCT02706951|144460479|SUPERIORITY||Response Rate Difference|36.8|||<|0.001|TWO_SIDED|95.0|28.6|45.0||This comparison was not part of the pre-specified multiplicity testing sequence; the nominal p-value is reported.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratification factor geographic region.|Response Rate Difference = Upadacitinib - Methotrexate|||45.0|28.6|<0.001
72468507|NCT02706951|144460480|SUPERIORITY||Response Rate Difference|19.8|||<|0.001|TWO_SIDED|95.0|13.8|25.8||This comparison was not part of the pre-specified multiplicity testing sequence; the nominal p-value is reported.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratification factor geographic region.|Response Rate Difference = Upadacitinib - Methotrexate|||25.8|13.8|<0.001
72468508|NCT02706951|144460480|SUPERIORITY||Response Rate Difference|30.2|||<|0.001|TWO_SIDED|95.0|23.6|36.9||This comparison was not part of the pre-specified multiplicity testing sequence; the nominal p-value is reported.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratification factor geographic region.|Response Rate Difference = Upadacitinib - Methotrexate|||36.9|23.6|<0.001
72468509|NCT04294667|144460481|SUPERIORITY|The difference in proportion responding between SOC+DZP 24mg/kg and SOC+PBO was estimated and tested using the Cochran-Mantel-Haenszel (CMH) risk difference estimate controlling for the randomization stratification factors, Pooled Region (North America vs Western Europe/Asia-Pacific vs Latin America/Eastern Europe), Screening disease activity (chronic active vs acute flaring) and Screening SLEDAI score (\<10 vs \>=10).|Difference in Proportions (%)|14.6||||0.011|TWO_SIDED|95.0|3.3|25.8|||Cochran-Mantel-Haenszel|||||25.8|3.3|0.0110
72468510|NCT04294667|144460482|SUPERIORITY|The difference in proportion responding between SOC+DZP 24mg/kg and SOC+PBO was estimated and tested using the CMH risk difference estimate controlling for the randomization stratification factors, Pooled Region (North America vs Western Europe/Asia-Pacific vs Latin America/Eastern Europe), Screening disease activity (chronic active vs acute flaring) and Screening SLEDAI score (\<10 vs \>=10).|Difference in Proportions (%)|7.9||||0.1776|TWO_SIDED|95.0|-3.6|19.4|||Cochran-Mantel-Haenszel|||||19.4|-3.6|0.1776
72468511|NCT04294667|144460483|SUPERIORITY|The difference in proportion responding between SOC+DZP 24mg/kg and SOC+PBO was estimated and tested using the CMH risk difference estimate controlling for the randomization stratification factors, Pooled Region (North America vs Western Europe/Asia-Pacific vs Latin America/Eastern Europe), Screening disease activity (chronic active vs acute flaring) and Screening SLEDAI score (\<10 vs \>=10).|Difference in Proportions (%)|10.8||||0.0518|TWO_SIDED|95.0|-0.1|21.7|||Cochran-Mantel-Haenszel|||||21.7|-0.1|0.0518
72468512|NCT04294667|144460484|SUPERIORITY|The difference in proportion responding between SOC+DZP 24mg/kg and SOC+PBO was estimated and tested using the CMH risk difference estimate controlling for the randomization stratification factors, Pooled Region (North America vs Western Europe/Asia-Pacific vs Latin America/Eastern Europe), Screening disease activity (chronic active vs acute flaring) and Screening SLEDAI score (\<10 vs \>=10).|Difference in Proportions (%)|11.5||||0.0257|TWO_SIDED|95.0|1.4|21.6|||Cochran-Mantel-Haenszel|||||21.6|1.4|0.0257
72468513|NCT04294667|144460485|SUPERIORITY|The difference in proportion responding between SOC+DZP 24mg/kg and SOC+PBO was estimated and tested using the Cochran-Mantel-Haenszel (CMH) risk difference estimate controlling for the randomization stratification factors, Pooled Region (North America vs Western Europe/Asia-Pacific vs Latin America/Eastern Europe), Screening disease activity (chronic active vs acute flaring) and Screening SLEDAI score (\<10 vs \>=10).|Difference in Proportions (%)|7.2||||0.1042|TWO_SIDED|95.0|-1.5|16.0|||Cochran-Mantel-Haenszel|||||16.0|-1.5|0.1042
72468514|NCT04294667|144460486|SUPERIORITY||Difference of Change(DZP+SOC vs PBO+SOC)|-1.8||||0.0001|TWO_SIDED|95.0|-2.7|-0.9|||MMRM|The Least Squares (LS) Mean, the difference (DZP+SOC versus PBO+SOC), and the 95% CIs was computed from the MMRM.||||-0.9|-2.7|0.0001
72468515|NCT04294667|144460491|SUPERIORITY|||||||0.0111|||||||Log Rank|||||||0.0111
72394721|NCT01170754|144295929|EQUIVALENCE|Equivalence between the two groups was defined as a p-value = or \>.05.||||||0.92|TWO_SIDED|95.0||||p\<.05 was defined as the a priori threshold for statistical significance|t-test, 2 sided|||||||.92
72394722|NCT01170754|144295930|EQUIVALENCE|Equivalence between the two groups was defined as a p-value = or \>.05.||||||0.6|TWO_SIDED|95.0||||p\<.05 was defined as the a priori threshold for statistical significance|t-test, 2 sided|||||||.60
72394723|NCT01170754|144295931|NON_INFERIORITY|Inferiority between groups was defined as a difference of 10% in the overall BBPS score.||||||0.98|TWO_SIDED|95.0||||p\<.05 was defined as the a priori threshold for statistical significance.|t-test, 2 sided|||||||.98
72468516|NCT04294667|144460492|SUPERIORITY|||||||0.0228|||||||Log Rank|||||||0.0228
72468517|NCT01841697|144460498|NON_INFERIORITY_OR_EQUIVALENCE|If the upper bound of the two-sided 95% confidence interval for the mean difference between omarigilptin and sitagliptin is less than the non-inferiority margin, δ =0.3%, then omarigliptin will be declared non-inferior to sitagliptin in terms of A1C reduction at Week 24.|Difference in least squares mean|-0.03|||||TWO_SIDED|95.0|-0.15|0.08|||||Difference is omarigliptin minus sitagliptin.|Constrained longitudinal data analysis||0.08|-0.15|
72468518|NCT01841697|144460499|SUPERIORITY_OR_OTHER||Difference in percent|-4.3|||||TWO_SIDED|95.0|-11.8|3.2|||||Difference is omarigliptin minus sitagliptin.|||3.2|-11.8|
72468519|NCT01841697|144460500|SUPERIORITY_OR_OTHER||Difference in percent|-1.3|||||TWO_SIDED|95.0|-3.6|0.8|||||Difference is omarigliptin minus sitagliptin.|||0.8|-3.6|
72468520|NCT01841697|144460501|SUPERIORITY_OR_OTHER||Difference in least squares mean|-4.2||||0.089|TWO_SIDED|95.0|-9.0|0.6|||Constrained logitudinal data analysis|Terms for treatment, time, and the interaction of time by treatment, with the constraint that the mean baseline is the same for all treatment groups.|Difference is omarigliptin minus sitagliptin.|||0.6|-9.0|0.089
72468521|NCT01841697|144460502|SUPERIORITY_OR_OTHER||Between-group rate difference|2.0||||0.619|TWO_SIDED|95.0|-5.9|9.9|||Miettinen & Nurminen method|||Proportion (rate) for each group was estimated using standard multiple imputation techniques. Between-group difference in proportion is omarigliptin minus sitagliptin.||9.9|-5.9|0.619
72468522|NCT01841697|144460503|SUPERIORITY_OR_OTHER||Between-group rate difference|4.4||||0.212|TWO_SIDED|95.0|-2.5|11.4|||Miettinen & Nurminen method|||Proportion (rate) for each group was estimated using standard multiple imputation techniques. Between-group difference in proportion is omarigliptin minus sitagliptin.||11.4|-2.5|0.212
72621972|NCT01421459|144774288|SUPERIORITY_OR_OTHER|||||||0.437||95.0||||P-value is for Behavior domain at Endpoint, up to 24 weeks.|ANCOVA|||||||0.437
72468523|NCT02635386|144460508|SUPERIORITY||||||<|0.02|||||||ANOVA|nested repeated measure||Repeated Measure general linear model (SS/Drug treatments by visits) including arm of drug treatment as between subjects effect and visit (baseline and post 22-24 weeks treatment) as within subject effect||||<0.02
72468524|NCT02635386|144460509|SUPERIORITY||||||<|0.0001|||||||ANOVA|Nested repeated measures design||Repeated Measure general linear model (SS/Drug treatments by visits) including arm of drug treatment as between subjects effect and visit (baseline and post 22-24 weeks treatment) as within subject effect||||<0.0001
72468525|NCT02635386|144460510|SUPERIORITY||||||<|0.0001|||||||ANOVA|Nested repeated measures design||Repeated Measure general linear model (SS/Drug treatments by visits) including arm of drug treatment as between subjects effect and visit (baseline and post 22-24 weeks treatment) as within subject effect||||<0.0001
72468526|NCT02635386|144460511|SUPERIORITY||||||<|0.0001|||||||ANOVA|one way with Bonferroni contrast||One way ANOVA with Bonferroni test to compare differences between groups if significant||||<0.0001
72468527|NCT02635386|144460512|SUPERIORITY||||||<|0.0001|||||||ANOVA|Nested repeated measures design||Repeated Measure general linear model (SS/Drug treatments by visits) including arm of drug treatment as between subjects effect and visit (baseline and post 22-24 weeks treatment) as within subject effect||||<0.0001
72468528|NCT02635386|144460513|SUPERIORITY||||||<|0.05|||||||ANOVA|Nested repeated measure design||Repeated Measure general linear model (SS/Drug treatments by visits) including arm of drug treatment as between subjects effect and visit (baseline and post 22-24 weeks treatment) as within subject effect||||<0.05
72468529|NCT02635386|144460514|SUPERIORITY||||||<|0.0001|||||||ANOVA|Nested repeated measures design||Repeated Measure general linear model (SS/Drug treatments by visits) including arm of drug treatment as between subjects effect and visit (baseline and post 22-24 weeks treatment) as within subject effect||||<0.0001
72504153|NCT01025336|144539191|SUPERIORITY_OR_OTHER||geometric mean fold rise|8.0|||||TWO_SIDED|95.0|5.82|11.09|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 4: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||11.09|5.82|
72504154|NCT01025336|144539191|SUPERIORITY_OR_OTHER||geometric mean fold rise|5.9|||||TWO_SIDED|95.0|4.25|8.21|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 4: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||8.21|4.25|
72565027|NCT00562120|144661736|SUPERIORITY_OR_OTHER|||||||0.087|TWO_SIDED|||||P-value was based on two-sided test which was underpowered and presented for descriptive purposes only. There were no further adjustments for multiplicity.|ANOVA|||An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||||0.087
72468530|NCT02635386|144460515|SUPERIORITY||||||<|0.0001|||||||ANOVA|Nested repeated measures design||Repeated Measure general linear model (SS/Drug treatments by visits) including arm of drug treatment as between subjects effect and visit (baseline and post 22-24 weeks treatment) as within subject effect||||<0.0001
72468531|NCT02635386|144460516|SUPERIORITY||||||<|0.0001|||||||ANOVA|Nested repeated measures design||Repeated Measure general linear model (SS/Drug treatments by visits) including arm of drug treatment as between subjects effect and visit (baseline and post 22-24 weeks treatment) as within subject effect||||<0.0001
72468532|NCT02635386|144460517|SUPERIORITY||||||<|0.01|||||||ANOVA|Nested repeated measures design||Repeated Measure general linear model (SS/Drug treatments by visits) including arm of drug treatment as between subjects effect and visit (baseline and post 22-24 weeks treatment) as within subject effect||||<0.01
72565028|NCT00562120|144661736|SUPERIORITY_OR_OTHER|||||||0.753|TWO_SIDED|||||P-value was based on two-sided test which was underpowered and presented for descriptive purposes only. There were no further adjustments for multiplicity.|ANOVA|||An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||||0.753
72621973|NCT01421459|144774288|SUPERIORITY_OR_OTHER|||||||0.237||95.0||||P-value is for Worry domain at 4 weeks.|ANCOVA|||||||0.237
72468533|NCT02635386|144460518|SUPERIORITY||||||<|0.035|||||||ANOVA|Nested repeated measures design||Repeated Measure general linear model (SS/Drug treatments by visits) including arm of drug treatment as between subjects effect and visit (baseline and post 22-24 weeks treatment) as within subject effect||||<0.035
72468534|NCT02635386|144460519|SUPERIORITY||||||<|0.0001|||||||ANOVA|Nested repeated measures design||Repeated Measure general linear model (SS/Drug treatments by visits) including arm of drug treatment as between subjects effect and visit (baseline and post 22-24 weeks treatment) as within subject effect||||<0.0001
72468535|NCT02635386|144460520|SUPERIORITY||||||<|0.02|||||||ANOVA|nested repeated measures design||Repeated Measure general linear model (SS/Drug treatments by visits) including arm of drug treatment as between subjects effect and visit (baseline and post 22-24 weeks treatment) as within subject effect||||<0.02
72468536|NCT02635386|144460521|SUPERIORITY||||||<|0.035|||||||ANOVA|Nested repeated measures design||Repeated Measure general linear model (SS/Drug treatments by visits) including arm of drug treatment as between subjects effect and visit (baseline and post 22-24 weeks treatment) as within subject effect||||<0.035
72504155|NCT01025336|144539191|SUPERIORITY_OR_OTHER||geometric mean fold rise|4.9|||||TWO_SIDED|95.0|3.96|6.0|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 5: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||6.00|3.96|
72504156|NCT01025336|144539191|SUPERIORITY_OR_OTHER||geometric mean fold rise|3.1|||||TWO_SIDED|95.0|2.58|3.79|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 5: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||3.79|2.58|
72565029|NCT00562120|144661737|SUPERIORITY_OR_OTHER|||||||0.011|TWO_SIDED|||||P-value was based on a one-sided test. There were no further adjustments for multiplicity.|ANOVA|||Nasal congestion: An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||||0.011
72621974|NCT01421459|144774288|SUPERIORITY_OR_OTHER|||||||0.86||95.0||||P-value is for Worry domain at 12 weeks.|ANCOVA|||||||0.860
72621975|NCT01421459|144774288|SUPERIORITY_OR_OTHER|||||||0.966||95.0||||P-value is for Worry domain at Endpoint, up to 24 weeks.|ANCOVA|||||||0.966
72565030|NCT00562120|144661737|SUPERIORITY_OR_OTHER|||||||0.127|TWO_SIDED|||||P-value was based on a one-sided test. There were no further adjustments for multiplicity.|ANOVA|||Nasal congestion: An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||||0.127
72565031|NCT00562120|144661737|SUPERIORITY_OR_OTHER|||||||0.103|TWO_SIDED|||||P-value was based on a one-sided test. There were no further adjustments for multiplicity.|ANOVA|||Nasal congestion: An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||||0.103
72565032|NCT00562120|144661737|SUPERIORITY_OR_OTHER|||||||0.218|TWO_SIDED|||||P-value was based on two-sided test which was underpowered and presented for descriptive purposes only. There were no further adjustments for multiplicity.|ANOVA|||Nasal congestion: An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||||0.218
72621976|NCT01421459|144774288|SUPERIORITY_OR_OTHER|||||||0.313||95.0||||P-value is for ALBSS Total Score at 4 weeks.|ANCOVA|||||||0.313
72621977|NCT01421459|144774288|SUPERIORITY_OR_OTHER|||||||0.683||95.0||||P-value is for ALBSS Total Score at 12 weeks.|ANCOVA|||||||0.683
72621978|NCT01421459|144774288|SUPERIORITY_OR_OTHER|||||||0.765||95.0||||P-value is for ALBSS Total Score at Endpoint, up to 24 weeks.|ANCOVA|||||||0.765
72468537|NCT02635386|144460522|SUPERIORITY||||||<|0.0001|||||||ANOVA|Nested repeated measures design||Repeated Measure general linear model (SS/Drug treatments by visits) including arm of drug treatment as between subjects effect and visit (baseline and post 22-24 weeks treatment) as within subject effect||||<0.0001
72468538|NCT02635386|144460523|SUPERIORITY||||||<|0.04|||||||ANOVA|Nested repeated measures design||Repeated Measure general linear model (SS/Drug treatments by visits) including arm of drug treatment as between subjects effect and visit (baseline and post 22-24 weeks treatment) as within subject effect||||<0.04
72468539|NCT02635386|144460524|SUPERIORITY||||||>|0.05|||||||ANOVA|Nested repeated measures design||Repeated Measure general linear model (SS/Drug treatments by visits) including arm of drug treatment as between subjects effect and visit (baseline and post 22-24 weeks treatment) as within subject effect||||>0.05
72621979|NCT01421459|144774289|SUPERIORITY_OR_OTHER|||||||0.983||95.0||||P-value is for Inconvenience of Regimen at 4 weeks.|ANCOVA|||||||0.983
72621980|NCT01421459|144774289|SUPERIORITY_OR_OTHER|||||||0.371||95.0||||P-value is for Inconvenience of Regimen at 12 weeks.|ANCOVA|||||||0.371
72621981|NCT01421459|144774289|SUPERIORITY_OR_OTHER|||||||0.757||95.0||||P-value is for Inconvenience of Regimen at Endpoint, up to 24 weeks.|ANCOVA|||||||0.757
72621982|NCT01421459|144774289|SUPERIORITY_OR_OTHER|||||||0.89||95.0||||P-value is for Lifestyle Flexibility at 4 weeks.|ANCOVA|||||||0.890
72621983|NCT01421459|144774289|SUPERIORITY_OR_OTHER|||||||0.326||95.0||||P-value is for Lifestyle Flexibility at 12 weeks.|ANCOVA|||||||0.326
72621984|NCT01421459|144774289|SUPERIORITY_OR_OTHER|||||||0.831||95.0||||P-value is for Lifestyle Flexibility at Endpoint, up to 24 weeks.|ANCOVA|||||||0.831
72468540|NCT02635386|144460525|SUPERIORITY||||||<|0.04|||||||ANOVA|Nested repeated measures design||Repeated Measure general linear model (SS/Drug treatments by visits) including arm of drug treatment as between subjects effect and visit (baseline and post 22-24 weeks treatment) as within subject effect||||<0.04
72468541|NCT02635386|144460526|SUPERIORITY||||||<|0.0001|||||||ANOVA|Nested repeated measures design||Repeated Measure general linear model (SS/Drug treatments by visits) including arm of drug treatment as between subjects effect and visit (baseline and post 22-24 weeks treatment) as within subject effect||||<0.0001
72565033|NCT00562120|144661737|SUPERIORITY_OR_OTHER|||||||0.905|TWO_SIDED|||||P-value was based on two-sided test which was underpowered and presented for descriptive purposes only. There were no further adjustments for multiplicity.|ANOVA|||Nasal congestion: An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||||0.905
72565034|NCT00562120|144661737|SUPERIORITY_OR_OTHER|||||||0.273|TWO_SIDED|||||P-value was based on two-sided test which was underpowered and presented for descriptive purposes only. There were no further adjustments for multiplicity.|ANOVA|||Nasal congestion: An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||||0.273
72621985|NCT01421459|144774289|SUPERIORITY_OR_OTHER|||||||0.507||95.0||||P-value is for Hypoglycemic Control at 4 weeks.|ANCOVA|||||||0.507
72621986|NCT01421459|144774289|SUPERIORITY_OR_OTHER|||||||0.69||95.0||||P-value is for Hypoglycemic Control at 12 weeks.|ANCOVA|||||||0.690
72621987|NCT01421459|144774289|SUPERIORITY_OR_OTHER|||||||0.307||95.0||||P-value is for Hypoglycemic Control at Endpoint, up to 24 weeks.|ANCOVA|||||||0.307
72621988|NCT01421459|144774289|SUPERIORITY_OR_OTHER|||||||0.902||95.0||||P-value is for Glycemic Control at 4 weeks.|ANCOVA|||||||0.902
72621989|NCT01421459|144774289|SUPERIORITY_OR_OTHER|||||||0.109||95.0||||P-value is for Glycemic Control at 12 weeks.|ANCOVA|||||||0.109
72621990|NCT01421459|144774289|SUPERIORITY_OR_OTHER|||||||0.754||95.0||||P-value is for Glycemic Control at Endpoint, up to 24 weeks.|ANCOVA|||||||0.754
72621991|NCT01421459|144774289|SUPERIORITY_OR_OTHER|||||||0.088||95.0||||P-value is for Insulin Deliver Device at 4 weeks.|ANCOVA|||||||0.088
72621992|NCT01421459|144774289|SUPERIORITY_OR_OTHER|||||||0.456||95.0||||P-value is for Insulin Delivery Device at 12 weeks.|ANCOVA|||||||0.456
72621993|NCT01421459|144774289|SUPERIORITY_OR_OTHER|||||||0.531||95.0||||P-value is for Insulin Delivery Device at Endpoint, up to 24 weeks.|ANCOVA|||||||0.531
72394724|NCT02254486|144295944|NON_INFERIORITY_OR_EQUIVALENCE|The confidence limits were adjusted for multiple comparisons (two alternative primary endpoints): To be declared non-inferior, the primary endpoint must show a difference in success rates of no greater than 10% in favor of Trisulfate Solution using lower 1-sided 97.5% confidence limits. Calculated using exact Clopper-Pearson confidence limits.|Difference in success rate|0.14||||0.528|ONE_SIDED|97.5|-8.15|||P-value adjusted for multiple comparisons (two alternative primary endpoints): To be declared superior, the primary endpoint must demonstrate non-inferiority with 1-sided p-value \<0.025, the threshold for statistical significance.|Fisher Exact|||The hypothesis was to demonstrate NI of NER1006 to Trisulfate Solution (TS) (10% margin). Success rate was number of patients with successful overall bowel cleansing as proportion of number of patients in each group. Treatment effect was NER1006 success rate - TS success rate. A Hochberg procedure was used to control Type I error since there were 2 alternative primary endpoints. An alpha level of 1.25% 1-sided was used. A closed testing procedure used to evaluate superiority if NI was met.|||-8.15|0.528
72394725|NCT02254486|144295945|NON_INFERIORITY_OR_EQUIVALENCE|The confidence limits were adjusted for multiple comparisons (two alternative primary endpoints): To be declared non-inferior the primary endpoint must show a difference in success rates of no greater than 10% in favour of Trisulfate Solution using lower 1-sided 97.5% confidence limits. Calculated using exact Clopper-Pearson confidence limits.|Difference in excellent plus good rate|6.58||||0.059|ONE_SIDED|97.5|-1.69|||P-value was adjusted for multiple comparisons (two alternative primary endpoints): To be declared superior, primary endpoint must demonstrate non-inferiority and with 1-sided p-value \<0.025; the threshold for statistical significance.|Fisher Exact|||The hypothesis was to demonstrate NI of NER1006 to Trisulfate Solution (TS) (10% margin). Success rate was number of patients with successful overall bowel cleansing as proportion of number of patients in each group. Treatment effect was NER1006 success rate - TS success rate. A Hochberg procedure was used to control Type I error since there were 2 alternative primary endpoints. An alpha level of 1.25% 1-sided was used. A closed testing procedure used to evaluate superiority if NI was met.|||-1.69|0.059
72394726|NCT02254486|144295946|NON_INFERIORITY_OR_EQUIVALENCE|To be declared non-inferior, the key secondary endpoint must show a difference in rates of no greater than 10% in favor of Trisulfate Solution using lower 1-sided 97.5% confidence limits. Calculated using exact Clopper-Pearson confidence limits.|Difference in ADR|-3.01||||0.863|TWO_SIDED|95.0|-11.36|5.28||To be declared superior, the key secondary endpoint must demonstrate non-inferiority and show a significant advantage for NER1006 relative to Trisulfate Solution with 1-sided p-value \<0.025, the threshold for statistical significance.|Fisher Exact|||If at least one of the alternative primary endpoints was met, then key secondary endpoints for the same colon region as met by the primary endpoint were evaluated hierarchically in a pre-specified order. The difference in ADR was calculated as NER1006 rate - TS rate using 1-sided 97.5% confidence limits. Formal testing was to proceed in the hierarchy if preceding key secondary endpoint met non-inferiority. This procedure ensured overall Type I error control at 2.5% 1-sided.||5.28|-11.36|0.863
72394727|NCT02254486|144295947|NON_INFERIORITY_OR_EQUIVALENCE|To be declared non-inferior, the key secondary endpoint must show a difference in rates of no greater than 10% in favor of Trisulfate Solution using lower 1-sided 97.5% confidence limits. Calculated using exact Clopper-Pearson confidence limits.||||||0.66||||||To be declared superior, the key secondary endpoint must demonstrate non-inferiority and show a significant advantage for NER1006 relative to Trisulfate Solution with 1-sided p-value \<0.025, the threshold for statistical significance.|Fisher Exact|||If at least one of the alternative primary endpoints was met, then key secondary endpoints for the same colon region as met by the primary endpoint were evaluated hierarchically in a pre-specified order. The difference in ADR was calculated as NER1006 rate - TS rate using 1-sided 97.5% confidence limits. Formal testing was to proceed in the hierarchy if preceding key secondary endpoint met non-inferiority. This procedure ensured overall Type I error control at 2.5% 1-sided.||||0.660
72468542|NCT02635386|144460527|SUPERIORITY||||||<|0.05|||||||ANOVA|Nested repeated measures design||Repeated Measure general linear model (SS/Drug treatments by visits) including arm of drug treatment as between subjects effect and visit (baseline and post 22-24 weeks treatment) as within subject effect||||<0.05
72468543|NCT02635386|144460528|SUPERIORITY||||||<|0.001|||||||ANOVA|Nested repeated measures design||Repeated Measure general linear model (SS/Drug treatments by visits) including arm of drug treatment as between subjects effect and visit (baseline and post 22-24 weeks treatment) as within subject effect||||<0.001
72468544|NCT02635386|144460529|SUPERIORITY||||||<|0.035|||||||ANOVA|Nested repeated measures design||Repeated Measure general linear model (SS/Drug treatments by visits) including arm of drug treatment as between subjects effect and visit (baseline and post 22-24 weeks treatment) as within subject effect||||<0.035
72468545|NCT02635386|144460530|SUPERIORITY||||||<|0.035|||||||ANOVA|Nested repeated measures design||Repeated Measure general linear model (SS/Drug treatments by visits) including arm of drug treatment as between subjects effect and visit (baseline and post 22-24 weeks treatment) as within subject effect||||<0.035
72468546|NCT02446613|144460531|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.1|STANDARD_DEVIATION|0.007|||TWO_SIDED|95.0|-1.41|5.43|||||The posterior probability statement value for change from baseline in post-challenge TNSS ≤0 was 0.1071.|||5.43|-1.41|
72621994|NCT01421459|144774289|SUPERIORITY_OR_OTHER|||||||0.393||95.0||||P-value is for ITSQ Total Score at 4 weeks.|ANCOVA|||||||0.393
72468547|NCT02446613|144460532|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.0|STANDARD_DEVIATION|0.007|||TWO_SIDED|95.0|-1.98|3.75|||||The posterior probability statement value for change from baseline in post-challenge TNSS ≤0 was 0.2417.|||3.75|-1.98|
72468548|NCT02446613|144460533|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.4|STANDARD_DEVIATION|0.007|||TWO_SIDED|95.0|-1.08|1.87|||||The posterior probability statement value for change from baseline in post-challenge TNSS ≤0 was 0.2876.|||1.87|-1.08|
72468549|NCT02446613|144460534|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|1.9|STANDARD_DEVIATION|0.006|||TWO_SIDED|95.0|-1.86|5.34|||||The posterior probability statement value for change from baseline in post-challenge TNSS ≤0 was 0.1453.|||5.34|-1.86|
72468550|NCT02446613|144460535|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|4.6|STANDARD_DEVIATION|0.006|||TWO_SIDED|95.0|-10.7|19.71|||||The posterior probability statement value for percentage reduction in the reductions of PNIF ≤0 was 0.2665.|||19.71|-10.70|
72468551|NCT02446613|144460536|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|4.3|STANDARD_DEVIATION|0.007|||TWO_SIDED|95.0|-14.97|24.38|||||The posterior probability statement value for percentage reduction in the reductions of PNIF ≤0 was 0.3266|||24.38|-14.97|
72394728|NCT02254486|144295948|NON_INFERIORITY_OR_EQUIVALENCE|To be declared non-inferior, the key secondary endpoint must show a difference in rates of no greater than 10% in favor of Trisulfate Solution using lower 1-sided 97.5% confidence limits. Calculated using exact Clopper-Pearson confidence limits.||||||0.953||||||To be declared superior, the key secondary endpoint must demonstrate non-inferiority and show a significant advantage for NER1006 relative to Trisulfate Solution with 1-sided p-value \<0.025, the threshold for statistical significance.|Fisher Exact|||If at least one of the alternative primary endpoints was met, then key secondary endpoints for the same colon region as met by the primary endpoint were evaluated hierarchically in a pre-specified order. The difference in PDR was calculated as NER1006 rate - Trisulfate Solution rate using 1-sided 97.5% confidence limits. Formal testing was to proceed in the hierarchy if preceding key secondary endpoint met non-inferiority. This procedure ensured overall Type I error control at 2.5% 1-sided.||||0.953
72394729|NCT02254486|144295949|NON_INFERIORITY_OR_EQUIVALENCE|Formal hierarchical testing of this key secondary endpoints was not performed due to the results of the non-inferiority analysis.||||||0.781|||||||Fisher Exact|||If at least one of the alternative primary endpoints were met, then key secondary endpoints were evaluated hierarchichally in a pre-specified order. Non-inferiority was concluded if the 1-sided 97.5% confidence limit (CL) for difference in proportion of events between 2 groups excluded a 10% or greater difference was in favor of Trisulate Solution. Formal testing was to proceed in the hierarchy if preceding key secondary endpoint had at least met non-inferiority.||||0.781
72394730|NCT01979016|144295999|SUPERIORITY||Least Squares (LS) Mean Difference|-69.4|||<|0.0001|TWO_SIDED|95.0|-92.5|-46.2|||ANCOVA||Dupilumab 200 mg qw vs Placebo qw|Analysis was performed by a mixed model repeated measures (MMRM) model.||-46.2|-92.5|< 0.0001
72468552|NCT02446613|144460537|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|1.1|STANDARD_DEVIATION|0.008|||TWO_SIDED|95.0|-17.47|19.2|||||The posterior probability statement value for percentage reduction in the reductions of PNIF ≤0 was 0.4528|||19.20|-17.47|
72468553|NCT02446613|144460538|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|6.6|STANDARD_DEVIATION|0.007|||TWO_SIDED|95.0|-13.69|28.04|||||The posterior probability statement value for percentage reduction in the reductions of PNIF ≤0 was 0.2525|||28.04|-13.69|
72468554|NCT01062269|144460540|SUPERIORITY_OR_OTHER||||||<|0.05||||||Differences between test products were assessed by repeated measures analysis of variance. If sequence was not found to be statistically significant(p\>0.05),then it was removed from the final model.|measures analysis of variance|Differences between test powders assessed by repeated measures analysis of variance, pairwise comparisons between treatments by Scheffe procedure.||"The BASA scale components were derived from the parameters best shown to differentiate acceptability between different BAS preparations (taste and texture),as well as other parameters useful for differentiating between different BAS preparations(appearance and mixability). The scale was then weighted based upon an Importance of Acceptability questionnaire regarding the individual scale components. The developed scale should reasonably allow for future comparisons of differing BAS formulations."||||<0.05
72468555|NCT03178045|144460546|OTHER|Multivariable Logistic Regression|Estimated Increase|0.23|||||TWO_SIDED|95.0|-3.1|3.6||||||||3.6|-3.1|
72468556|NCT03178045|144460547|OTHER|Multivariable logistic regression|Odds Ratio (OR)|0.95|||||TWO_SIDED|95.0|0.69|1.31||||||||1.31|0.69|
72468557|NCT03178045|144460548|OTHER|Longitudinal mixed effects regression|Odds Ratio (OR)|0.89|||||TWO_SIDED|95.0|0.6|1.32||||||||1.32|0.60|
72468558|NCT02706847|144460560|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure.|Response Rate Difference|36.2|||<|0.001|TWO_SIDED|95.0|26.2|46.2||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification factor of prior biological DMARD use (stratum 1 vs stratum 2).|Response Rate Difference = Upadacitinib - Placebo|||46.2|26.2|<0.001
72468559|NCT02706847|144460560|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure.|Response Rate Difference|28.0|||<|0.001|TWO_SIDED|95.0|17.8|38.1||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification factor of prior biological DMARD use (stratum 1 vs stratum 2).|Response Rate Difference = Upadacitinib - Placebo|||38.1|17.8|<0.001
72621995|NCT01421459|144774289|SUPERIORITY_OR_OTHER|||||||0.296||95.0||||P-value is for ITSQ Total Score at 12 weeks.|ANCOVA|||||||0.296
72468560|NCT02706847|144460561|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure.|Response Rate Difference|29.1|||<|0.001|TWO_SIDED|95.0|19.9|38.3||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification factor of prior biological DMARD use (stratum 1 vs stratum 2).|Response Rate Difference = Upadacitinib - Placebo|||38.3|19.9|<0.001
72468561|NCT02706847|144460561|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure.|Response Rate Difference|28.2|||<|0.001|TWO_SIDED|95.0|19.0|37.4||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification factor of prior biological DMARD use (stratum 1 vs stratum 2).|Response Rate Difference = Upadacitinib - Placebo|||37.4|19.0|<0.001
72504157|NCT01025336|144539191|SUPERIORITY_OR_OTHER||geometric mean fold rise|11.9|||||TWO_SIDED|95.0|8.56|16.49|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 6A: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||16.49|8.56|
72621996|NCT01421459|144774289|SUPERIORITY_OR_OTHER|||||||0.662||95.0||||P-value is for ITSQ Total Score at Endpoint, up to 24 weeks.|ANCOVA|||||||0.662
72621997|NCT01421459|144774290|SUPERIORITY_OR_OTHER|||||||0.393||95.0|||||ANCOVA|||||||0.393
72621998|NCT01421459|144774291|SUPERIORITY_OR_OTHER|||||||0.185||95.0||||P-value is for Insulin Dose at Endpoint, up to 24 weeks.|ANOVA|||||||0.185
72621999|NCT01421459|144774292|SUPERIORITY_OR_OTHER|||||||0.661||95.0||||P-value is for HbA1c \<7% at Baseline.|Chi-squared|||||||0.661
72468562|NCT02706847|144460562|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure.|LS Mean Difference|-1.29|||<|0.001|TWO_SIDED|95.0|-1.57|-1.01||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|ANCOVA|Analysis of covariance (ANCOVA) model with treatment, prior biological DMARD use (stratum 1 vs stratum 2) and baseline value as covariates.|Treatment Difference = Upadacitinib - Placebo|||-1.01|-1.57|<0.001
72468563|NCT02706847|144460562|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure.|LS Mean Difference|-1.28|||<|0.001|TWO_SIDED|95.0|-1.56|-0.99||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|ANCOVA|ANCOVA model with treatment, prior biological DMARD use (stratum 1 vs stratum 2) and baseline value as covariates.|Treatment Difference = Upadacitinib - Placebo|||-0.99|-1.56|<0.001
72468564|NCT02706847|144460563|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure.|LS Mean Difference|-0.22|||<|0.001|TWO_SIDED|95.0|-0.34|-0.1||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|ANCOVA|ANCOVA model with treatment, prior biological DMARD use (stratum 1 vs stratum 2) and baseline value as covariates.|Treatment Difference = Upadacitinib - Placebo|||-0.10|-0.34|<0.001
72468565|NCT02706847|144460563|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure.|LS Mean Difference|-0.25|||<|0.001|TWO_SIDED|95.0|-0.38|-0.13||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|ANCOVA|ANCOVA model with treatment, prior biological DMARD use (stratum 1 vs stratum 2) and baseline value as covariates.|Treatment Difference = Upadacitinib - Placebo|||-0.13|-0.38|<0.001
72468566|NCT02706847|144460564|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure.|LS Mean DIfference|3.44|||<|0.001|TWO_SIDED|95.0|1.72|5.15||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|Mixed Effect Model Repeat Measurement|MMRM model with fixed effects of treatment, visit, and treatment-by-visit interaction, previous bDMARD use, and baseline value as covariate.|Treatment Difference = Upadacitinib - Placebo|||5.15|1.72|<0.001
72468567|NCT02706847|144460564|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure.|LS Mean Difference|4.63|||<|0.001|TWO_SIDED|95.0|2.89|6.36||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|Mixed Effect Model Repeat Measurement|MMRM model with fixed effects of treatment, visit, and treatment-by-visit interaction, previous bDMARD use, and baseline value as covariate.|Treatment Difference = Upadacitinib - Placebo|||6.36|2.89|<0.001
72468568|NCT02706847|144460565|SUPERIORITY||Response Rate Difference|22.3|||<|0.001|TWO_SIDED|95.0|13.6|31.1||The nominal p-value is reported|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification factor of prior biological DMARD use (stratum 1 vs stratum 2).|Response Rate Difference = Upadacitinib - Placebo|||31.1|13.6|<0.001
72468569|NCT02706847|144460565|SUPERIORITY||Response Rate Difference|23.9|||<|0.001|TWO_SIDED|95.0|15.1|32.7||The nominal p-value is reported|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification factor of prior biological DMARD use (stratum 1 vs stratum 2).|Response Rate Difference = Upadacitinib - Placebo|||32.7|15.1|<0.001
72468570|NCT02706847|144460566|SUPERIORITY||Response Rate Difference|5.1||||0.11|TWO_SIDED|95.0|-1.1|11.2||The nominal p-value is reported|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification factor of prior biological DMARD use (stratum 1 vs stratum 2).|Response Rate Difference = Upadacitinib - Placebo|||11.2|-1.1|0.110
72468571|NCT02706847|144460566|SUPERIORITY||Response Rate Difference|16.5|||<|0.001|TWO_SIDED|95.0|9.1|23.9||The nominal p-value is reported|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification factor of prior biological DMARD use (stratum 1 vs stratum 2).|Response Rate Difference = Upadacitinib - Placebo|||23.9|9.1|<0.001
72622000|NCT01421459|144774292|SUPERIORITY_OR_OTHER|||||||0.394||95.0||||P-value is for HbA1c ≤ 6.5% at Baseline.|Chi-squared|||||||0.394
72622001|NCT01421459|144774292|SUPERIORITY_OR_OTHER|||||||0.688||95.0||||P-value is for HbA1c \<7% at 4 weeks.|Chi-squared|||||||0.688
72468572|NCT02706847|144460567|SUPERIORITY||Response Rate Difference|16.8|||<|0.001|TWO_SIDED|95.0|8.5|25.1||The nominal p-value is reported|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification factor of prior biological DMARD use (stratum 1 vs stratum 2).|Response Rate Difference = Upadacitinib - Placebo|||25.1|8.5|<0.001
72468573|NCT02706847|144460567|SUPERIORITY||Response Rate Difference|14.2|||<|0.001|TWO_SIDED|95.0|6.1|22.3||The nominal p-value is reported|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification factor of prior biological DMARD use (stratum 1 vs stratum 2).|Response Rate Difference = Upadacitinib - Placebo|||22.3|6.1|<0.001
72504158|NCT01025336|144539191|SUPERIORITY_OR_OTHER||geometric mean fold rise|3.5|||||TWO_SIDED|95.0|2.59|4.76|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 6A: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||4.76|2.59|
72504159|NCT01025336|144539191|SUPERIORITY_OR_OTHER||geometric mean fold rise|6.5|||||TWO_SIDED|95.0|4.61|9.03|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 6B: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||9.03|4.61|
72622002|NCT01421459|144774292|SUPERIORITY_OR_OTHER||||||>|0.999||95.0||||P-value is for HbA1c ≤ 6.5% at 4 weeks.|Chi-squared|||||||>0.999
72622003|NCT01421459|144774292|SUPERIORITY_OR_OTHER|||||||0.409||95.0||||P-value is for HbA1c \<7% at 8 weeks.|Chi-squared|||||||0.409
72622004|NCT01421459|144774292|SUPERIORITY_OR_OTHER|||||||0.09||95.0||||P-value is for HbA1c ≤ 6.5% at 8 weeks.|Chi-squared|||||||0.090
72622005|NCT01421459|144774292|SUPERIORITY_OR_OTHER|||||||0.319||95.0||||P-value is for HbA1c \<7% at 12 weeks.|Chi-squared|||||||0.319
72468574|NCT00763451|144460584|SUPERIORITY_OR_OTHER||Least squares (LS) mean difference|-0.41|STANDARD_ERROR_OF_MEAN|0.089|<|0.0001|TWO_SIDED|95.0|-0.583|-0.232||Stepwise testing procedure applied to control type 1 error: Lixisenatide (2-step titration) was compared with Placebo (combined), if found statistically significant, then Lixisenatide (1-step titration) arm compared with Placebo (combined).|ANCOVA|Threshold for significance at 0,05 level||"To detect a difference of 0.5% (or 0.4%) in absolute change from baseline in HbA1c at Week 24 between 1 lixisenatide arm and placebo (combined), 150 patients per group would provide a power of 91% (or 75%) assuming common standard deviation of 1.3% with 2-sided test at 5% significance level.~Analysis of co-variance (ANCOVA) included treatment arms, randomization strata of screening HbA1c (\<8.0,\>=8.0%) and screening BMI (\<30,\>=30 kg/m\^2), country as fixed effects, baseline HbA1c as covariate."||-0.232|-0.583|<0.0001
72565035|NCT00562120|144661737|SUPERIORITY_OR_OTHER|||||||0|TWO_SIDED|||||P-value was based on a one-sided test. There were no further adjustments for multiplicity.|ANOVA|||Nasal Itching: An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||||0.000
72565036|NCT00562120|144661737|SUPERIORITY_OR_OTHER|||||||0.055|TWO_SIDED|||||P-value was based on a one-sided test. There were no further adjustments for multiplicity.|ANOVA|||Nasal Itching: An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||||0.055
72565037|NCT00562120|144661737|SUPERIORITY_OR_OTHER|||||||0.012|TWO_SIDED|||||P-value was based on a one-sided test. There were no further adjustments for multiplicity.|ANOVA|||Nasal Itching: An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||||0.012
72622006|NCT01421459|144774292|SUPERIORITY_OR_OTHER|||||||0.463||95.0||||P-value is for HbA1c ≤6.5% at 12 weeks.|Chi-squared|||||||0.463
72468575|NCT00763451|144460584|SUPERIORITY_OR_OTHER||Least squares (LS) mean difference|-0.49|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001|TWO_SIDED|95.0|-0.67|-0.317||Stepwise testing procedure applied to control type 1 error: Lixisenatide (2-step titration) was compared with Placebo (combined), if found statistically significant, then Lixisenatide (1-step titration) arm compared with Placebo (combined).|ANCOVA|Threshold for significance at 0,05 level||"To detect a difference of 0.5% (or 0.4%) in absolute change from baseline in HbA1c at Week 24 between 1 lixisenatide arm and placebo (combined), 150 patients per group would provide a power of 91% (or 75%) assuming common standard deviation of 1.3% with 2-sided test at 5% significance level.~Analysis of co-variance (ANCOVA) included treatment arms, randomization strata of screening HbA1c (\<8.0,\>=8.0%) and screening BMI (\<30,\>=30 kg/m\^2), country as fixed effects, baseline HbA1c as covariate."||-0.317|-0.670|<0.0001
72468576|NCT05594589|144460602|SUPERIORITY||Least Squares Geometric Mean(LSGM) Ratio|0.377||||0.0133|TWO_SIDED|95.0|0.175|0.81|||ANCOVA|P-value was based on analysis of covariance (ANCOVA) model with log transformation of baseline LPS and treatment arms as fixed effects.|LSGM ratio was calculated as Lemborexant 5 mg/Placebo.|||0.810|0.175|0.0133
72468577|NCT05594589|144460603|SUPERIORITY||LSGM Ratio|0.48||||0.0619|TWO_SIDED|95.0|0.222|1.038|||ANCOVA|P-value was based on ANCOVA model with log transformation of baseline LPS and treatment arms as fixed effects.|LSGM ratio was calculated as Lemborexant 10 mg/Placebo.|||1.038|0.222|0.0619
72468578|NCT05594589|144460604|SUPERIORITY||Least Square Mean (LSM) Difference|7.38||||0.0689|TWO_SIDED|95.0|-0.59|15.35|||ANCOVA|P-value was based on ANCOVA model with log transformation of baseline LPS and treatment arms as fixed effects.|LSM difference was calculated as Lemborexant 5 mg - Placebo.|||15.35|-0.59|0.0689
72468579|NCT05594589|144460605|SUPERIORITY||LSM Difference|8.16||||0.0439|TWO_SIDED|95.0|0.23|16.09|||ANCOVA|P-value was based on ANCOVA model with log transformation of baseline LPS and treatment arms as fixed effects.|LSM difference was calculated as Lemborexant 10 mg - Placebo.|||16.09|0.23|0.0439
72468580|NCT00087555|144460612|SUPERIORITY_OR_OTHER|||||||0.052||95.0|||||Chi-squared|||||||0.052
72468581|NCT00087555|144460612|SUPERIORITY_OR_OTHER|||||||0.024||95.0|||||Chi-squared|||||||0.024
72468582|NCT00087555|144460612|SUPERIORITY_OR_OTHER|||||||0.035||95.0|||||Chi-squared|||||||0.035
72468583|NCT01427738|144460620|SUPERIORITY_OR_OTHER||Difference in proportion with clinical e|0.044|||||TWO_SIDED|95.1|-0.077|0.166||||||Repeated confidence intervals (RCIs) were used to control type I error.A interim analysis was conducted by a 99.7% CI. The final analyses use a 95.1% CI, based on the Lan-DeMets error-spending function corresponding to the O'Brien-Fleming boundary.76% of 100 participant in arm GV had cure or improvement of OC after 14 days of treatment, and 71.6% of 102 in arm nystatin had cure or improvement of OC. Difference in clinical efficacy rates between GV and nystatin 95.1% CI is 0.044 (-0.077, 0.166).||0.166|-0.077|
72468584|NCT02554383|144460632|SUPERIORITY|||||||0.02||||||The interactions (1) between treatment \& pathogens and (2) between treatment \& colored nasal discharge are tested simultaneously.|Mixed Models Analysis|The p value is adjusted for PRSS score at enrollment, diary day, study site, treatment, pathogens, colored nasal discharge \& interaction (2).||Null hypothesis: The effect of treatment with antibiotics does not differ in the subgroups of children defined, respectively, by the presence and by the absence of pathogens in the nasopharynx at enrollment, i.e., there is no significant interaction between treatment and pathogens in the nasopharynx.||||0.02
72565038|NCT00562120|144661737|SUPERIORITY_OR_OTHER|||||||0.048|TWO_SIDED|||||P-value was based on two-sided test which was underpowered and presented for descriptive purposes only. There were no further adjustments for multiplicity.|ANOVA|||Nasal Itching: An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||||0.048
72565039|NCT00562120|144661737|SUPERIORITY_OR_OTHER|||||||0.496|TWO_SIDED|||||P-value was based on two-sided test which was underpowered and presented for descriptive purposes only. There were no further adjustments for multiplicity.|ANOVA|||Nasal Itching: An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||||0.496
72622007|NCT01421459|144774292|SUPERIORITY_OR_OTHER|||||||0.128||95.0||||P-value is for HbA1c \<7% at 16 weeks.|Chi-squared|||||||0.128
72622008|NCT01421459|144774292|SUPERIORITY_OR_OTHER|||||||0.261||95.0||||P-value is for HbA1c ≤6.5% at 16 weeks.|Chi-squared|||||||0.261
72622009|NCT01421459|144774292|SUPERIORITY_OR_OTHER|||||||0.218||95.0||||P-value is for HbA1c \<7% at 20 weeks.|Chi-squared|||||||0.218
72622010|NCT01421459|144774292|SUPERIORITY_OR_OTHER|||||||0.092||95.0||||P-value is for HbA1c ≤6.5% at 20 weeks.|Chi-squared|||||||0.092
72622011|NCT01421459|144774292|SUPERIORITY_OR_OTHER|||||||0.186||95.0||||P-value is for HbA1c \<7%% at 24 weeks.|Chi-squared|||||||0.186
72468585|NCT02554383|144460632|SUPERIORITY||Difference of least-squares means|-1.95|||||TWO_SIDED|95.0|-2.4|-1.51|||||The Amoxicillin-clavulanate group represents the first number in the subtraction and the Placebo group represents the second. The estimates are adjusted for PRSS score at enrollment, diary day and study site.|Null hypothesis: There is no difference between the treatment groups in the subgroup of children defined by the presence of one or more pathogens in the nasopharynx at enrollment.||-1.51|-2.40|
72468586|NCT02554383|144460632|SUPERIORITY||Difference of least-squares means|-0.88|||||TWO_SIDED|95.0|-1.63|-0.12|||||The Amoxicillin-clavulanate group represents the first number in the subtraction and the Placebo group represents the second. The estimates are adjusted for PRSS score at enrollment, diary day and study site.|Null hypothesis: There is no difference between the treatment groups in the subgroup of children defined by the absence of one or more pathogens in the nasopharynx at enrollment.||-0.12|-1.63|
72468587|NCT02554383|144460633|SUPERIORITY|||||||0.37||||||The interactions (1) between treatment \& pathogens and (2) between treatment \& colored nasal discharge are tested simultaneously.|Mixed Models Analysis|The p value is adjusted for PRSS score at enrollment, diary day, study site, treatment, pathogens, colored nasal discharge \& interaction (1).||Null hypothesis: The effect of treatment with antibiotics does not differ in the subgroups of children defined, respectively, by the presence and by the absence of colored nasal discharge at enrollment, i.e., there is no significant interaction between treatment and colored nasal discharge.||||0.37
72468588|NCT02554383|144460633|SUPERIORITY||Difference of least-squares means|-1.62|||||TWO_SIDED|95.0|-2.09|-1.16|||||The Amoxicillin-clavulanate group represents the first number in the subtraction and the Placebo group represents the second. The estimates are adjusted for PRSS score at enrollment, diary day and study site.|Null hypothesis: There is no difference between the treatment groups in the subgroup of children defined by the presence of colored nasal discharge at enrollment.||-1.16|-2.09|
72468589|NCT02554383|144460633|SUPERIORITY||Difference of least-squares means|-1.7|||||TWO_SIDED|95.0|-2.38|-1.03|||||The Amoxicillin-clavulanate group represents the first number in the subtraction and the Placebo group represents the second. The estimates are adjusted for PRSS score at enrollment, diary day and study site.|Null hypothesis: There is no difference between the treatment groups in the subgroup of children defined by the absence of colored nasal discharge at enrollment.||-1.03|-2.38|
72468590|NCT02554383|144460634|SUPERIORITY|||||||0.003|||||||Log-binomial regression|The p-value is adjusted for study site and and presence of colored nasal discharge.||Null hypothesis: There is no difference between the treatment groups in the proportion of children experiencing treatment failure.||||0.003
72468591|NCT02554383|144460635|SUPERIORITY|||||||0.007|||||||Fisher Exact|||Null hypothesis: There is no difference between the treatment groups in the proportion of children developing AOM over the first 10 days of follow-up.||||.007
72468592|NCT02554383|144460636|SUPERIORITY||||||<|0.001|||||||Log-binomial regression|The p-value is adjusted for study site and and presence of colored nasal discharge.||Null hypothesis: There is no difference between the treatment groups in the proportion of children receiving a systemic antibiotic over the first 10 days of follow-up.||||<0.001
72504160|NCT01025336|144539191|SUPERIORITY_OR_OTHER||geometric mean fold rise|3.1|||||TWO_SIDED|95.0|2.32|4.24|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 6B: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||4.24|2.32|
72504161|NCT01025336|144539191|SUPERIORITY_OR_OTHER||geometric mean fold rise|7.4|||||TWO_SIDED|95.0|5.23|10.33|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 7F: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||10.33|5.23|
72504162|NCT01025336|144539191|SUPERIORITY_OR_OTHER||geometric mean fold rise|5.6|||||TWO_SIDED|95.0|4.07|7.69|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 7F: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||7.69|4.07|
72622012|NCT01421459|144774292|SUPERIORITY_OR_OTHER|||||||0.174||95.0||||P-value is for HbA1c ≤6.5% at 24 weeks.|Chi-squared|||||||0.174
72504163|NCT01025336|144539191|SUPERIORITY_OR_OTHER||geometric mean fold rise|3.6|||||TWO_SIDED|95.0|2.5|5.2|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 9V: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||5.20|2.50|
72504164|NCT01025336|144539191|SUPERIORITY_OR_OTHER||geometric mean fold rise|2.9|||||TWO_SIDED|95.0|2.1|4.04|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 9V: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||4.04|2.10|
72504165|NCT01025336|144539191|SUPERIORITY_OR_OTHER||geometric mean fold rise|2.9|||||TWO_SIDED|95.0|2.26|3.71|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 14: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||3.71|2.26|
72622013|NCT01421459|144774292|SUPERIORITY_OR_OTHER|||||||0.34||95.0||||P-value is for HbA1c \<7% at Endpoint, up to 24 weeks.|Chi-squared|||||||0.340
72622014|NCT01421459|144774292|SUPERIORITY_OR_OTHER|||||||0.293||95.0||||P-value is for HbA1c ≤6.5% at Endpoint, up to 24 weeks.|Chi-squared|||||||0.293
72622015|NCT01421459|144774293|SUPERIORITY_OR_OTHER|||||||0.594||95.0||||P-value is for Total Hypoglycemic with BG ≤70 mg/dL events.|Chi-squared|||||||0.594
72504166|NCT01025336|144539191|SUPERIORITY_OR_OTHER||geometric mean fold rise|2.8|||||TWO_SIDED|95.0|2.23|3.63|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 14: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||3.63|2.23|
72504167|NCT01025336|144539191|SUPERIORITY_OR_OTHER||geometric mean fold rise|4.1|||||TWO_SIDED|95.0|3.16|5.2|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 18C: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||5.20|3.16|
72504168|NCT01025336|144539191|SUPERIORITY_OR_OTHER||geometric mean fold rise|2.5|||||TWO_SIDED|95.0|2.06|3.14|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 18C: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||3.14|2.06|
72504169|NCT01025336|144539191|SUPERIORITY_OR_OTHER||geometric mean fold rise|3.0|||||TWO_SIDED|95.0|2.46|3.6|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 19A: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||3.60|2.46|
72622016|NCT01421459|144774293|SUPERIORITY_OR_OTHER|||||||0.462||95.0||||P-value is for Nocturnal Hypoglycemic with BG ≤70 mg/dL events.|Chi-squared|||||||0.462
72622017|NCT01421459|144774294|SUPERIORITY_OR_OTHER|||||||0.995||95.0||||P-value is for Total Hypoglycemia with BG ≤70 mg/dL events.|Wilcoxon (Mann-Whitney)|||||||0.995
72468593|NCT02554383|144460637|SUPERIORITY|||||||0.004|||||||Log-binomial regression|The p-value is adjusted for study site and presence of colored nasal discharge.||Null hypothesis: There is no difference between the treatment groups in the proportion of children for whom diarrhea or generalized rash was reported.||||0.004
72468594|NCT02554383|144460638|SUPERIORITY|||||||0.75|||||||Log-binomial regression|The p-value is adjusted for presence of colored nasal discharge.||Null hypothesis: There is no difference between the treatment groups in the proportion of children compliant with study product.||||0.75
72468595|NCT02554383|144460639|SUPERIORITY|||||||0.63|||||||Log-binomial regression|The p-value is adjusted for study site and presence of colored nasal discharge.||Null hypothesis: There is no difference between the treatment groups in the proportion of children with a nonsusceptible pathogen at the follow-up visit.||||0.63
72504170|NCT01025336|144539191|SUPERIORITY_OR_OTHER||geometric mean fold rise|2.7|||||TWO_SIDED|95.0|2.24|3.15|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 19A: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||3.15|2.24|
72504171|NCT01025336|144539191|SUPERIORITY_OR_OTHER||geometric mean fold rise|5.9|||||TWO_SIDED|95.0|4.55|7.76|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 19F: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||7.76|4.55|
72504172|NCT01025336|144539191|SUPERIORITY_OR_OTHER||geometric mean fold rise|4.0|||||TWO_SIDED|95.0|3.13|5.17|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 19F: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||5.17|3.13|
72504173|NCT01025336|144539191|SUPERIORITY_OR_OTHER||geometric mean fold rise|6.9|||||TWO_SIDED|95.0|5.16|9.25|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 23F: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||9.25|5.16|
72504174|NCT01025336|144539191|SUPERIORITY_OR_OTHER||geometric mean fold rise|2.8|||||TWO_SIDED|95.0|2.24|3.4|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 23F: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||3.40|2.24|
72504175|NCT01025336|144539192|SUPERIORITY_OR_OTHER||Ratio of GMT|1.5|||||TWO_SIDED|95.0|1.02|2.08|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[13vPnC/23vPS-23vPS/13vPnC)\].|Serotype 1: Ratio of GMT (13vPnC/23vPS to 23vPS/13vPnC) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale.||2.08|1.02|
72504176|NCT01025336|144539192|SUPERIORITY_OR_OTHER||Ratio|1.5|||||TWO_SIDED|95.0|1.14|1.99|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/23vPS-23vPS/13vPnC)\].|Serotype 3: Ratio of GMT (13vPnC/23vPS to 23vPS/13vPnC) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale.||1.99|1.14|
72504177|NCT01025336|144539192|SUPERIORITY_OR_OTHER||Ratio|1.9|||||TWO_SIDED|95.0|1.22|3.06|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/23vPS-23vPS/13vPnC)\].|Serotype 4: Ratio of GMT (13vPnC/23vPS to 23vPS/13vPnC) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale.||3.06|1.22|
72504178|NCT01025336|144539192|SUPERIORITY_OR_OTHER||Ratio|1.7|||||TWO_SIDED|95.0|1.15|2.56|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/23vPS-23vPS/13vPnC)\].|Serotype 5: Ratio of GMT (13vPnC/23vPS to 23vPS/13vPnC) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale.||2.56|1.15|
72622018|NCT01421459|144774294|SUPERIORITY_OR_OTHER|||||||0.686||95.0||||P-value is for Nocturnal Hypoglycemia with BG ≤70 mg/dL events.|Wilcoxon (Mann-Whitney)|||||||0.686
72622019|NCT01421459|144774295|SUPERIORITY_OR_OTHER|||||||0.285||95.0||||P-value is for Baseline.|Chi-squared|||||||0.285
72622020|NCT01421459|144774295|SUPERIORITY_OR_OTHER|||||||0.047||95.0||||P-value is for 4 weeks.|Chi-squared|||||||0.047
72622021|NCT01421459|144774295|SUPERIORITY_OR_OTHER|||||||0.882||95.0||||P-value is for 12 weeks.|Chi-squared|||||||0.882
72622022|NCT01421459|144774295|SUPERIORITY_OR_OTHER|||||||0.179||95.0||||P-value is for 24 weeks.|Chi-squared|||||||0.179
72504179|NCT01025336|144539192|SUPERIORITY_OR_OTHER||Ratio|2.2|||||TWO_SIDED|95.0|1.36|3.53|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/23vPS-23vPS/13vPnC)\].|Serotype 6A: Ratio of GMT (13vPnC/23vPS to 23vPS/13vPnC) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale.||3.53|1.36|
72622023|NCT01421459|144774295|SUPERIORITY_OR_OTHER|||||||0.314||95.0||||P-value is for Endpoint, up to 24 weeks.|Chi-squared|||||||0.314
72622024|NCT01421459|144774295|SUPERIORITY_OR_OTHER|||||||0.1||95.0||||P-value is for Baseline to 24 weeks (Overall).|Chi-squared|||||||0.100
72622025|NCT01421459|144774296|SUPERIORITY_OR_OTHER|||||||0.176||95.0||||P-value is for 4 weeks.|Chi-squared|||||||0.176
72394731|NCT01979016|144296000|SUPERIORITY||Percentage difference|37.0|||=|0.0006|TWO_SIDED|95.0|18.82|55.25|||Cochran-Mantel-Haenszel||Dupilumab 200 mg qw vs Placebo qw|Analysis was performed by a MMRM model.||55.25|18.82|= 0.0006
72394732|NCT01979016|144296001|SUPERIORITY||Percentage difference|48.1|||<|0.0001|TWO_SIDED|95.0|28.0|68.3|||Cochran-Mantel-Haenszel||Dupilumab 200 mg qw vs Placebo qw|Analysis was performed by a MMRM model.||68.30|28.00|< 0.0001
72394733|NCT01979016|144296002|SUPERIORITY||LS Mean Difference|-2.66|||<|0.0001|TWO_SIDED|95.0|-3.8|-1.52|||ANCOVA||Dupilumab 200 mg qw vs Placebo qw|Analysis was performed by a MMRM model.||-1.52|-3.80|< 0.0001
72504180|NCT01025336|144539192|SUPERIORITY_OR_OTHER||Ratio|1.8|||||TWO_SIDED|95.0|1.15|2.91|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/23vPS-23vPS/13vPnC)\].|Serotype 6B: Ratio of GMT (13vPnC/23vPS to 23vPS/13vPnC) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale.||2.91|1.15|
72504181|NCT01025336|144539192|SUPERIORITY_OR_OTHER||Ratio|2.8|||||TWO_SIDED|95.0|1.8|4.44|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/23vPS-23vPS/13vPnC)\].|Serotype 7F: Ratio of GMT (13vPnC/23vPS to 23vPS/13vPnC) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale.||4.44|1.80|
72504182|NCT01025336|144539192|SUPERIORITY_OR_OTHER||Ratio|1.7|||||TWO_SIDED|95.0|0.99|2.96|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/23vPS-23vPS/13vPnC)\].|Serotype 9V: Ratio of GMT (13vPnC/23vPS to 23vPS/13vPnC) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale.||2.96|0.99|
72504183|NCT01025336|144539192|SUPERIORITY_OR_OTHER||Ratio|1.1|||||TWO_SIDED|95.0|0.73|1.62|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/23vPS-23vPS/13vPnC)\].|Serotype 14: Ratio of GMT (13vPnC/23vPS to 23vPS/13vPnC) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale.||1.62|0.73|
72504184|NCT01025336|144539192|SUPERIORITY_OR_OTHER||Ratio|1.6|||||TWO_SIDED|95.0|1.02|2.39|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/23vPS-23vPS/13vPnC)\].|Serotype 18C: Ratio of GMT (13vPnC/23vPS to 23vPS/13vPnC) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale.||2.39|1.02|
72504185|NCT01025336|144539192|SUPERIORITY_OR_OTHER||Ratio|1.8|||||TWO_SIDED|95.0|1.38|2.45|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/23vPS-23vPS/13vPnC)\].|Serotype 19A: Ratio of GMT (13vPnC/23vPS to 23vPS/13vPnC) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale.||2.45|1.38|
72504186|NCT01025336|144539192|SUPERIORITY_OR_OTHER||Ratio|2.2|||||TWO_SIDED|95.0|1.53|3.12|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/23vPS-23vPS/13vPnC)\].|Serotype 19F: Ratio of GMT (13vPnC/23vPS to 23vPS/13vPnC) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale.||3.12|1.53|
72504187|NCT01025336|144539192|SUPERIORITY_OR_OTHER||Ratio|1.8|||||TWO_SIDED|95.0|1.18|2.82|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/23vPS-23vPS/13vPnC)\].|Serotype 23F: Ratio of GMT (13vPnC/23vPS to 23vPS/13vPnC) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale.||2.82|1.18|
72504188|NCT01025336|144539193|SUPERIORITY_OR_OTHER||Ratio of GMT|1.5|||||TWO_SIDED|95.0|1.02|2.25|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/13vPnC - 23vPS/13vPnC)\]|Serotype 1: Ratio of GMT (13vPnC/13vPnC to 23vPS/13vPnC) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale.||2.25|1.02|
72622026|NCT01421459|144774296|SUPERIORITY_OR_OTHER|||||||0.999||95.0||||P-value is for 12 weeks.|Chi-squared|||||||0.999
72394734|NCT01979016|144296003|SUPERIORITY||LS Mean Difference|-48.08|||=|0.0001|TWO_SIDED|95.0|-71.31|-24.85|||ANCOVA||Dupilumab 200 mg qw vs Placebo qw|Analysis was performed by a MMRM model.||-24.85|-71.31|= 0.0001
72504189|NCT01025336|144539193|SUPERIORITY_OR_OTHER||Ratio of GMT|1.1|||||TWO_SIDED|95.0|0.78|1.44|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/13vPnC - 23vPS/13vPnC)\]|Serotype 3: Ratio of GMT (13vPnC/13vPnC to 23vPS/13vPnC) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale.||1.44|0.78|
72504190|NCT01025336|144539193|SUPERIORITY_OR_OTHER||Ratio of GMT|1.8|||||TWO_SIDED|95.0|1.06|3.0|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/13vPnC - 23vPS/13vPnC)\]|Serotype 4: Ratio of GMT (13vPnC/13vPnC to 23vPS/13vPnC) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale.||3.00|1.06|
72394735|NCT01979016|144296004|SUPERIORITY||LS Mean Difference|-21.5|||<|0.0001|TWO_SIDED|95.0|-29.0|-14.0|||ANCOVA||Dupilumab 200 mg qw vs Placebo qw|Analysis was performed by a MMRM model.||-14.0|-29.0|<0.0001
72394736|NCT01979016|144296005|SUPERIORITY||LS Mean Difference|-31.3|||<|0.0001|TWO_SIDED|95.0|-41.5|-21.1|||ANCOVA||Dupilumab 200 mg qw vs Placebo qw|Analysis was performed by a MMRM model.||-21.1|-41.5|< 0.0001
72565040|NCT00562120|144661737|SUPERIORITY_OR_OTHER|||||||0.19|TWO_SIDED|||||P-value was based on two-sided test which was underpowered and presented for descriptive purposes only. There were no further adjustments for multiplicity.|ANOVA|||Nasal Itching: An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||||0.190
72622027|NCT01421459|144774296|SUPERIORITY_OR_OTHER|||||||0.618||95.0||||P-value is for 24 weeks.|Chi-squared|||||||0.618
72394737|NCT01979016|144296006|SUPERIORITY||LS Mean Difference|-46.6|||<|0.0001|TWO_SIDED|95.0|-62.0|-31.3|||ANCOVA||Dupilumab 200 mg qw vs Placebo qw|Analysis was performed by MMRM model.||-31.3|-62.0|< 0.0001
72394738|NCT01979016|144296007|SUPERIORITY||Percentage difference|55.6|||<|0.0001|TWO_SIDED|95.0|33.38|77.73|||Cochran-Mantel-Haenszel|||Statistical comparison for percentage of participants who achieved 50% reduction from baseline in EASI score (EASI-50). Analysis was performed by a MMRM model.||77.73|33.38|< 0.0001
72468596|NCT01214421|144460648|SUPERIORITY||Ratio of geometric means (final values)|0.99||||0.358|TWO_SIDED|95.0|0.96|1.02|||Mixed Models Analysis||||Derived from the least squares (LS) mean difference between the treatment groups at each visit using MMRM model with factors of treatment, visit, region, baseline, baseline hypertensive status, baseline renal volume status, baseline creatinine clearance status, interaction of treatment and visit, and interaction of baseline and visit.|1.02|0.96|0.358
72468597|NCT01214421|144460649|SUPERIORITY||LS mean difference (final values)|3.15||||0.0003|TWO_SIDED|95.0|1.462|4.836|||Mixed Models Analysis||||Derived from MMRM analysis with fixed factors of treatment, visit, treatment visit interaction, hypertensive status, renal volume status and creatinine clearance status at baseline, region, baseline value, and baseline visit interaction as covariates, and with a heterogeneous toeplitz variance covariance matrix.|4.836|1.462|0.0003
72504191|NCT01025336|144539193|SUPERIORITY_OR_OTHER||Ratio of GMT|0.7|||||TWO_SIDED|95.0|0.41|1.04|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/13vPnC - 23vPS/13vPnC)\]|Serotype 5: Ratio of GMT (13vPnC/13vPnC to 23vPS/13vPnC) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale.||1.04|0.41|
72504192|NCT01025336|144539193|SUPERIORITY_OR_OTHER||Ratio of GMT|3.1|||||TWO_SIDED|95.0|1.82|5.24|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/13vPnC - 23vPS/13vPnC)\]|Serotype 6A: Ratio of GMT (13vPnC/13vPnC to 23vPS/13vPnC) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale.||5.24|1.82|
72504193|NCT01025336|144539193|SUPERIORITY_OR_OTHER||Ratio of GMT|2.4|||||TWO_SIDED|95.0|1.43|4.11|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/13vPnC - 23vPS/13vPnC)\]|Serotype 6B: Ratio of GMT (13vPnC/13vPnC to 23vPS/13vPnC) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale.||4.11|1.43|
72504194|NCT01025336|144539193|SUPERIORITY_OR_OTHER||Ratio of GMT|1.7|||||TWO_SIDED|95.0|0.96|3.0|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/13vPnC - 23vPS/13vPnC)\]|Serotype 7F: Ratio of GMT (13vPnC/13vPnC to 23vPS/13vPnC) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale.||3.00|0.96|
72504195|NCT01025336|144539193|SUPERIORITY_OR_OTHER||Ratio of GMT|1.6|||||TWO_SIDED|95.0|0.88|3.04|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/13vPnC - 23vPS/13vPnC)\]|Serotype 9V: Ratio of GMT (13vPnC/13vPnC to 23vPS/13vPnC) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale.||3.04|0.88|
72622028|NCT01421459|144774296|SUPERIORITY_OR_OTHER|||||||0.874||95.0||||P-value is for Endpoint (LOCF).|Chi-squared|||||||0.874
72622029|NCT01421459|144774296|SUPERIORITY_OR_OTHER||||||>|0.233||95.0||||P-value is for Overall (Baseline to 24 weeks).|Chi-squared|||||||>0.233
72468598|NCT01214421|144460650|NON_INFERIORITY|The non-inferiority for early-treatment and delayed-treatment groups.|Ratio of geometric means (final values)|1.011||||0.0462|TWO_SIDED|95.0|1.0|1.023|||Mixed Models Analysis||||Derived from testing interaction of time and treatment using linear mixed model in which intercept and time are treated as random effects.|1.023|1.000|0.0462
72504196|NCT01025336|144539193|SUPERIORITY_OR_OTHER||Ratio of GMT|1.0|||||TWO_SIDED|95.0|0.64|1.54|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/13vPnC - 23vPS/13vPnC)\]|Serotype 14: Ratio of GMT (13vPnC/13vPnC to 23vPS/13vPnC) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale.||1.54|0.64|
72504197|NCT01025336|144539193|SUPERIORITY_OR_OTHER||Ratio of GMT|1.2|||||TWO_SIDED|95.0|0.71|1.93|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/13vPnC - 23vPS/13vPnC)\]|Serotype 18C: Ratio of GMT (13vPnC/13vPnC to 23vPS/13vPnC) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale.||1.93|0.71|
72622030|NCT00803049|144774298|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.824||||0.2079|TWO_SIDED|95.0|0.602|1.128||Threshold for significance at 0.05 level.|Log Rank||Placebo/Teriflunomide 7 mg vs. Teriflunomide 7 mg/7 mg|Analysis was performed using Log-rank test with treatment, EDSS strata at baseline and region as covariates. Estimation was performed using Cox proportional hazard model with treatment, EDSS strata at baseline and region as covariates.||1.128|0.602|0.2079
72622031|NCT00803049|144774298|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.825||||0.3039|TWO_SIDED|95.0|0.591|1.152||Threshold for significance at 0.05 level.|Log Rank||Placebo/Teriflunomide 14 mg vs.Teriflunomide 14 mg/14 mg|Analysis was performed using Log-rank test with treatment, EDSS strata at baseline and region as covariates. Estimation was performed using Cox proportional hazard model with treatment, EDSS strata at baseline and region as covariates.||1.152|0.591|0.3039
72622032|NCT00803049|144774298|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.963||||0.8271|TWO_SIDED|95.0|0.736|1.26||Threshold for significance at 0.05 level.|Log Rank||Teriflunomide 7 mg/7 mg vs. Teriflunomide 14 mg/14 mg|Analysis was performed using Log-rank test with treatment, EDSS strata at baseline and region as covariates. Estimation was performed using Cox proportional hazard model with treatment, EDSS strata at baseline and region as covariates.||1.260|0.736|0.8271
72622033|NCT00803049|144774299|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.961||||0.8017|TWO_SIDED|95.0|0.678|1.362||Threshold for significance at 0.05 level.|Log Rank||Placebo/Teriflunomide 7 mg vs. Teriflunomide 7 mg/7 mg|Analysis was performed using Log-rank test with treatment, EDSS strata at baseline and region as covariates. Estimation was performed using Cox proportional hazard model with treatment, EDSS strata at baseline and region as covariates.||1.362|0.678|0.8017
72622034|NCT00803049|144774299|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.79||||0.1866|TWO_SIDED|95.0|0.559|1.117||Threshold for significance at 0.05 level.|Log Rank||Placebo/Teriflunomide 14 mg vs. Teriflunomide 14 mg/14 mg|Analysis was performed using Log-rank test with treatment, EDSS strata at baseline and region as covariates. Estimation was performed using Cox proportional hazard model with treatment, EDSS strata at baseline and region as covariates.||1.117|0.559|0.1866
72622035|NCT00803049|144774299|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.02||||0.8763|TWO_SIDED|95.0|0.767|1.357||Threshold for significance at 0.05 level.|Log Rank||Teriflunomide 7 mg/7 mg vs. Teriflunomide 14 mg/14 mg|Analysis was performed using Log-rank test with treatment, EDSS strata at baseline and region as covariates. Estimation was performed using Cox proportional hazard model with treatment, EDSS strata at baseline and region as covariates.||1.357|0.767|0.8763
72394739|NCT01979016|144296007|SUPERIORITY||Percentage difference|51.9|||=|0.0001|TWO_SIDED|95.0|29.59|74.12|||Cochran-Mantel-Haenszel|||Statistical comparison for percentage of participants who achieved 75% reduction from baseline in EASI score (EASI-75). Analysis was performed by a MMRM model.||74.12|29.59|= 0.0001
72468599|NCT01214421|144460651|NON_INFERIORITY|The non-inferiority for early-treatment and delayed-treatment groups.|Ratio of geometric means (final values)|-0.113||||0.7259|TWO_SIDED|95.0|-0.746|0.52|||Mixed Models Analysis||||Derived from testing interaction of time and treatment using linear mixed model in which intercept and time are treated as random effects.|0.520|-0.746|0.7259
72468600|NCT01214421|144460652|SUPERIORITY||Ratio of geometric means (final values)|0.992||||0.108|TWO_SIDED|95.0|0.982|1.002|||Mixed Models Analysis||||Derived from linear mixed model with terms of participant, treatment, time, interaction of treatment and time, interaction of participant and time, and baseline for intra-participant comparison between 251 and 271. Time and intercept are treated as random effects.|1.002|0.982|0.1080
72468601|NCT01214421|144460653|SUPERIORITY||Ratio of geometric means (final values)|0.361||||0.2265|TWO_SIDED|95.0|-0.224|0.946|||Mixed Models Analysis||||Derived from linear mixed model with terms of participant, treatment, time, interaction of treatment and time, interaction of participant and time, and baseline for intra-participant comparison between 251 and 271. Time and intercept are treated as random effects.|0.946|-0.224|0.2265
72468602|NCT04887506|144460707|EQUIVALENCE|If the 90% confidence interval (CI) fell within the recommended 0.800-1.250 limits of equivalence when analyzed on a natural log scale, then treatments were therapeutically equivalent based on rounded-up average Days 9 and 10 testosterone levels.|Geometric mean ratio|1.0|||||TWO_SIDED|90.0|||||||The 90% CIs for the geometric mean ratio (GMR) were not evaluable.|Primary analysis of equivalence of TAVT 45 and R AA based on average serum testosterone (ng/dL) (rounded up values of Days 9 and 10).||||
72504198|NCT01025336|144539193|SUPERIORITY_OR_OTHER||Ratio of GMT|1.4|||||TWO_SIDED|95.0|1.01|2.04|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/13vPnC - 23vPS/13vPnC)\]|Serotype 19A: Ratio of GMT (13vPnC/13vPnC to 23vPS/13vPnC) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale.||2.04|1.01|
72504199|NCT01025336|144539193|SUPERIORITY_OR_OTHER||Ratio of GMT|1.3|||||TWO_SIDED|95.0|0.84|2.06|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/13vPnC - 23vPS/13vPnC)\]|Serotype 19F: Ratio of GMT (13vPnC/13vPnC to 23vPS/13vPnC) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale.||2.06|0.84|
72504200|NCT01025336|144539193|SUPERIORITY_OR_OTHER||Ratio of GMT|3.1|||||TWO_SIDED|95.0|1.89|5.2|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/13vPnC - 23vPS/13vPnC)\]|Serotype 23F: Ratio of GMT (13vPnC/13vPnC to 23vPS/13vPnC) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale.||5.20|1.89|
72504201|NCT01025336|144539194|SUPERIORITY_OR_OTHER||Ratio of GMT|1.0|||||TWO_SIDED|95.0|0.72|1.51|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/13vPnC - 13vPnC/23vPS)\]|Serotype 1: Ratio of GMT (13vPnC/13vPnC to 13vPnC/23vPS) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale.||1.51|0.72|
72504202|NCT01025336|144539194|SUPERIORITY_OR_OTHER||Ratio of GMT|0.7|||||TWO_SIDED|95.0|0.52|0.94|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/13vPnC - 13vPnC/23vPS)\]|Serotype 3: Ratio of GMT (13vPnC/13vPnC to 13vPnC/23vPS) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale.||0.94|0.52|
72504203|NCT01025336|144539194|SUPERIORITY_OR_OTHER||Ratio of GMT|0.9|||||TWO_SIDED|95.0|0.58|1.47|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/13vPnC - 13vPnC/23vPS)\]|Serotype 4: Ratio of GMT (13vPnC/13vPnC to 13vPnC/23vPS) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale.||1.47|0.58|
72504204|NCT01025336|144539194|SUPERIORITY_OR_OTHER||Ratio of GMT|0.4|||||TWO_SIDED|95.0|0.25|0.59|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/13vPnC - 13vPnC/23vPS)\]|Serotype 5: Ratio of GMT (13vPnC/13vPnC to 13vPnC/23vPS) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale.||0.59|0.25|
72622036|NCT04003142|144774317|SUPERIORITY|Least squares Mean (LSM), Standard error (SE), Confidence interval (CI), Mixed model repeated measures (MMRM), Change from Baseline (CFB), Dependent variable (dv), Treatment (tr), Week (wk), Baseline (bl), Weight (wt)|Least squares (LS) Mean difference|-1.82|STANDARD_ERROR_OF_MEAN|0.46|<|0.001|TWO_SIDED|95.0|-2.73|-0.91||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||||-0.91|-2.73|<0.001
72468603|NCT04887506|144460708|EQUIVALENCE|If the 90% CI fell within the recommended 0.800-1.250 limits of equivalence when analyzed on a natural log scale, then treatments were therapeutically equivalent based on rounded-up average Days 9 and 10 testosterone levels.|Geometric mean ratio|0.975|||||TWO_SIDED|90.0|0.944|1.007||||||Supplementary analysis of equivalence of TAVT-45 and R-AA based on average serum testosterone (ng/dL) (rounded up values of Days 9 and 10) in the CS-ITT population.||1.007|0.944|
72468604|NCT04887506|144460709|EQUIVALENCE|If the 90% CI fell within the recommended 0.800-1.250 limits of equivalence when analyzed on a natural log scale, then treatments were therapeutically equivalent based on rounded-up average Days 9 and 10 testosterone levels.|Geometric mean ratio|0.99|||||TWO_SIDED|90.0|0.978|1.002||||||Supplementary analysis of equivalence of TAVT-45 and R-AA based on average serum testosterone (ng/dL) (rounded up values of Days 9 and 10) in the mITT population.||1.002|0.978|
72468605|NCT04887506|144460710|EQUIVALENCE|Odds ratio generated using the Wald method.|Odds Ratio (OR)|1.69||||0.3408|TWO_SIDED|95.0|0.574|4.979|||Regression, Logistic|||||4.979|0.574|0.3408
72468606|NCT01999777|144460711|SUPERIORITY|||||||0.1972|||||||Wald asymptotic|P-value based on a standard Wald asymptotic test for equality without a continuity correction.||Assumptions included that the proportion of seizures occurring within 6 hours after placebo administration was \~65% and a relative reduction of 50% would result in a reduction of ≥ 32.5 percentage points. Based on a 2-sided 95% confidence interval (CI) for the differences in proportions, a sample size of 62 analyzable subjects was chosen to detect a 0.35 difference between group. Sample size estimations were based on nQuery Version 7.0 using the table for CIs for differences in 2 proportions.||||0.1972
72468607|NCT01999777|144460712|SUPERIORITY|||||||0.1388|||||||Log Rank|||||||0.1388
72468608|NCT01255761|144460739|NON_INFERIORITY_OR_EQUIVALENCE|If the lower bound of the 2-sided 95 % CI was greater than -10 %, the null hypothesis was rejected and RAPID3 was deemed comparable to CDAI in assessing response to Certolizumab Pegol therapy at 12 weeks.|Difference in proportion|-0.119|||||TWO_SIDED|95.0|-0.184|-0.053||Study was intended to show the comparability of RAPID3 with CDAI. Assessment of whether the study objective was met was based on CIs rather than p-values. Both variables need to be significant to claim comparability between the two assessment tools.|ANCOVA|Difference in proportions from ANCOVA with tool as factor \& Baseline DAS28(ESR), gender, age, prior anti-TNF use \& disease duration as covariates.||"The null hypothesis was: (Proportion of Rapid 3 responders)-(Proportion of CDAI responders) ≤ delta with a delta of -10 %.~A 2-sided 95 % Confidence Interval (CI) for the difference in proportion of responders was computed."||-0.053|-0.184|
72468609|NCT01255761|144460740|NON_INFERIORITY_OR_EQUIVALENCE|If the lower bound of the 2-sided 95 % CI was greater than -15 %, the null hypothesis was rejected and RAPID3 was deemed comparable to CDAI in assessing percent of Week 12 responders achieving LDA at Week 52.|Difference in proportion|-0.013|||||TWO_SIDED|95.0|-0.093|0.066||Study was intended to show the comparability of RAPID3 with CDAI. Assessment of whether the study objective was met was based on CIs rather than p-values. Both variables need to be significant to claim comparability between the two assessment tools.|ANCOVA|Difference in proportions from ANCOVA with tool as factor \& Baseline DAS28(ESR), gender, age, prior anti-TNF use \& disease duration as covariates.||"The null hypothesis was: (Proportion of Rapid 3 responders)-(Proportion of CDAI responders) ≤ delta with a delta of -15 %.~A 2-sided 95 % Confidence Interval (CI) for the difference in proportion of responders was computed."||0.066|-0.093|
72468610|NCT03506347|144460778|SUPERIORITY|||||||0.001|||||||ANOVA|||||||0.001
72468611|NCT03506347|144460779|SUPERIORITY|||||||0.009|||||||ANOVA|||||||0.009
72468612|NCT05613088|144460792|SUPERIORITY||Hazard Ratio (HR)|1.23||||0.4063|TWO_SIDED|95.0|0.76|2.0|||Log Rank|||||2.00|0.76|0.4063
72468613|NCT03912532|144460793|OTHER|The Multiple Comparison Procedure-Modelling (MCP-Mod) is a 2-stage procedure in which dose-response models are selected at the design stage. These candidate models are used for both dose-response testing (MCP step) and estimation (Mod step). The dose-response testing is performed using a multiple comparison method to account for the multiplicity issue associated with the multiple candidate models. Missing responses were imputed using multiple imputation under the assumption of missing at random.||||||0.5534|||||||Multiple comparison procedure step|||||||0.5534
72468614|NCT01641653|144460826|SUPERIORITY_OR_OTHER|||||||0.87|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||This is a pilot study no power calculation was performed. The Wilcoxon rank-sum test was used to assess differences in max intraop glucose between placebo and midazolam groups.||||0.87
72468615|NCT01641653|144460827|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|10.0||||0.56|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||percent change in glucose levels from preoperative level to maximum perioperative measurement level||||0.56
72468616|NCT01641653|144460828|SUPERIORITY_OR_OTHER|||||||0.12|TWO_SIDED|||||Chi-square with continuity correction|Chi-squared, Corrected|||||||0.12
72394740|NCT01979016|144296007|SUPERIORITY||Percentage difference|33.3|||=|0.0011|TWO_SIDED|95.0|15.55|51.11|||Cochran-Mantel-Haenszel|||Statistical comparison for percentage of participants who achieved 90% reduction from baseline in EASI score (EASI-90). Analysis was performed by a MMRM model.||51.11|15.55|= 0.0011
72468617|NCT01473745|144460837|SUPERIORITY_OR_OTHER|||||||0.098|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||ANS X axis||||0.098
72468618|NCT01473745|144460837|SUPERIORITY_OR_OTHER|||||||0.389|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||ANS Y axis||||0.389
72468619|NCT01473745|144460837|SUPERIORITY_OR_OTHER|||||||0.78|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||ANS Z axis||||0.780
72468620|NCT01473745|144460837|SUPERIORITY_OR_OTHER|||||||0.054|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||A point X axis||||0.054
72468621|NCT01473745|144460837|SUPERIORITY_OR_OTHER|||||||0.323|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||A point Y axis||||0.323
72468622|NCT01473745|144460837|SUPERIORITY_OR_OTHER|||||||0.371|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||A point X axis||||0.371
72468623|NCT01473745|144460837|SUPERIORITY_OR_OTHER|||||||0.011|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||UI level X axis||||0.011
72468624|NCT01473745|144460837|SUPERIORITY_OR_OTHER|||||||0.426|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||UI level Y axis||||0.426
72468625|NCT01473745|144460837|SUPERIORITY_OR_OTHER|||||||0.621|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||UI level Z axis||||0.621
72468626|NCT01473745|144460837|SUPERIORITY_OR_OTHER|||||||0.275|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||pronasale X axis||||0.275
72468627|NCT01473745|144460837|SUPERIORITY_OR_OTHER|||||||0.361|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||pronasale Y axis||||0.361
72468628|NCT01473745|144460837|SUPERIORITY_OR_OTHER|||||||0.284|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||pronasale Z axis||||0.284
72468629|NCT01473745|144460837|SUPERIORITY_OR_OTHER|||||||0.119|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||subnasale X axis||||0.119
72468630|NCT01473745|144460837|SUPERIORITY_OR_OTHER|||||||0.019|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||subnasale Y axis||||0.019
72468631|NCT01473745|144460837|SUPERIORITY_OR_OTHER|||||||0.034|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||subnasale Z axis||||0.034
72468632|NCT01473745|144460837|SUPERIORITY_OR_OTHER|||||||0.422|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||labiale superious X axis||||0.422
72565041|NCT00562120|144661737|SUPERIORITY_OR_OTHER|||||||0|TWO_SIDED|||||P-value was based on a one-sided test. There were no further adjustments for multiplicity.|ANOVA|||Rhinorrhea: An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||||0.000
72565042|NCT00562120|144661737|SUPERIORITY_OR_OTHER|||||||0.019|TWO_SIDED|||||P-value was based on a one-sided test. There were no further adjustments for multiplicity.|ANOVA|||Rhinorrhea: An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||||0.019
72565043|NCT00562120|144661737|SUPERIORITY_OR_OTHER|||||||0.009|TWO_SIDED|||||P-value was based on a one-sided test. There were no further adjustments for multiplicity.|ANOVA|||Rhinorrhea: An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||||0.009
72565044|NCT00562120|144661737|SUPERIORITY_OR_OTHER|||||||0.061|TWO_SIDED|||||P-value was based on two-sided test which was underpowered and presented for descriptive purposes only. There were no further adjustments for multiplicity.|ANOVA|||Rhinorrhea: An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||||0.061
72565045|NCT00562120|144661737|SUPERIORITY_OR_OTHER|||||||0.778|TWO_SIDED|||||P-value was based on two-sided test which was underpowered and presented for descriptive purposes only. There were no further adjustments for multiplicity.|ANOVA|||Rhinorrhea: An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||||0.778
72622037|NCT04003142|144774317|SUPERIORITY||LSMean difference|-2.55|STANDARD_ERROR_OF_MEAN|0.46|<|0.001||95.0|-3.45|-1.64||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||||-1.64|-3.45|<0.001
72622038|NCT04003142|144774317|SUPERIORITY|||||||0.049|||||||Hochberg|||||||0.049
72622039|NCT04003142|144774317|SUPERIORITY||||||<|0.001|||||||Hochberg|||||||<0.001
72622040|NCT04003142|144774318|SUPERIORITY||LSMean Difference|-1.86|STANDARD_ERROR_OF_MEAN|0.55|<|0.001||95.0|-2.94|-0.78||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||||-0.78|-2.94|<0.001
72622041|NCT04003142|144774318|SUPERIORITY||LSMean difference|-2.53|STANDARD_ERROR_OF_MEAN|0.55|<|0.001|TWO_SIDED|95.0|-3.6|-1.46||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||||-1.46|-3.60|<0.001
72622042|NCT04003142|144774318|SUPERIORITY|||||||0.049|||||||Hochberg|||||||0.049
72468633|NCT01473745|144460837|SUPERIORITY_OR_OTHER|||||||0.177|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||labiale superious Y axis||||0.177
72468634|NCT01473745|144460837|SUPERIORITY_OR_OTHER|||||||0.133|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||labiale superious Z axis||||0.133
72468635|NCT01473745|144460838|SUPERIORITY_OR_OTHER|||||||0.218|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||Intercanthal distance||||0.218
72468636|NCT01473745|144460838|SUPERIORITY_OR_OTHER|||||||0.336|TWO_SIDED||||||t-test, 2 sided|P- value \< 0.05 was set as statistical significance.||nasal height||||0.336
72468637|NCT01473745|144460838|SUPERIORITY_OR_OTHER|||||||0.192|TWO_SIDED||||||t-test, 2 sided|P- value \< 0.05 was set as statistical significance||||||0.192
72468638|NCT01473745|144460838|SUPERIORITY_OR_OTHER|||||||0.135|TWO_SIDED||||||t-test, 2 sided|P value \< 0.05 was set as statistical significance.||nasal tip protrusion||||0.135
72565046|NCT00562120|144661737|SUPERIORITY_OR_OTHER|||||||0.102|TWO_SIDED|||||P-value was based on two-sided test which was underpowered and presented for descriptive purposes only. There were no further adjustments for multiplicity.|ANOVA|||Rhinorrhea: An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||||0.102
72565047|NCT00562120|144661738|SUPERIORITY_OR_OTHER|||||||0|TWO_SIDED|||||P-value was based on a one-sided test. There were no further adjustments for multiplicity.|ANOVA|||An analysis of variance (ANOVA) mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||||0.000
72565048|NCT00562120|144661738|SUPERIORITY_OR_OTHER|||||||0|TWO_SIDED|||||P-value was based on a one-sided test. There were no further adjustments for multiplicity.|ANOVA|||An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||||0.000
72565049|NCT00562120|144661738|SUPERIORITY_OR_OTHER|||||||0|TWO_SIDED|||||P-value was based on a one-sided test. There were no further adjustments for multiplicity.|ANOVA|||An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||||0.000
72565050|NCT00562120|144661738|SUPERIORITY_OR_OTHER|||||||0.217|TWO_SIDED|||||P-value was based on two-sided test which was underpowered and presented for descriptive purposes only. There were no further adjustments for multiplicity.|ANOVA|||An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||||0.217
72622043|NCT04003142|144774318|SUPERIORITY||||||<|0.001|||||||Hochberg|||||||<0.001
72622044|NCT04003142|144774319|SUPERIORITY||LSMean difference|-0.15|STANDARD_ERROR_OF_MEAN|0.06||0.021||95.0|-0.27|-0.02||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||||-0.02|-0.27|0.021
72622045|NCT04003142|144774319|SUPERIORITY||LSMean difference|-0.29|STANDARD_ERROR_OF_MEAN|0.06|<|0.001||95.0|-0.41|-0.16||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||||-0.16|-0.41|<0.001
72622046|NCT04003142|144774319|SUPERIORITY|||||||0.049|||||||Hochberg|||||||0.049
72622047|NCT04003142|144774319|SUPERIORITY||||||<|0.001|||||||Hochberg|||||||<0.001
72468639|NCT01473745|144460838|SUPERIORITY_OR_OTHER|||||||0.277|TWO_SIDED||||||t-test, 2 sided|P value \< 0.05 was set as statistical significance.||nasal width||||0.277
72468640|NCT01473745|144460838|SUPERIORITY_OR_OTHER|||||||0.505|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||alar base width||||0.505
72468641|NCT01473745|144460838|SUPERIORITY_OR_OTHER|||||||0.299|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||R nostril show vertical dimension||||0.299
72468642|NCT01473745|144460838|SUPERIORITY_OR_OTHER|||||||0.738|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||L nostril show vertical dimension||||0.738
72468643|NCT01473745|144460838|SUPERIORITY_OR_OTHER|||||||0.008|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||columellar length||||0.008
72468644|NCT01473745|144460838|SUPERIORITY_OR_OTHER|||||||0.116|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||cutaneious height of upper lip||||0.116
72468645|NCT01473745|144460838|SUPERIORITY_OR_OTHER|||||||0.528|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||overall upper lip height||||0.528
72468646|NCT01473745|144460838|SUPERIORITY_OR_OTHER|||||||0.123|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||vermillion height of upper lip||||0.123
72468647|NCT01473745|144460838|SUPERIORITY_OR_OTHER|||||||0.25|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||lower prolabial width||||0.250
72468648|NCT01473745|144460838|SUPERIORITY_OR_OTHER|||||||0.706|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||upper lip protrusion||||0.706
72468649|NCT01473745|144460838|SUPERIORITY_OR_OTHER|||||||0.804|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||intercanthal distance||||0.804
72468650|NCT01473745|144460838|SUPERIORITY_OR_OTHER|||||||0.114|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||nasal height||||0.114
72468651|NCT01473745|144460838|SUPERIORITY_OR_OTHER|||||||0.457|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||Nasal length||||0.457
72622048|NCT04003142|144774320|SUPERIORITY||LSMean difference|-0.16|STANDARD_ERROR_OF_MEAN|0.08||0.049||95.0|-0.33|0.0||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||||0.00|-0.33|0.049
72622049|NCT04003142|144774320|SUPERIORITY||LSMean difference|-0.29|STANDARD_ERROR_OF_MEAN|0.08|<|0.001||95.0|-0.45|-0.13||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||||-0.13|-0.45|<0.001
72468652|NCT01473745|144460838|SUPERIORITY_OR_OTHER|||||||0.565|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||Nasal tip protrusion||||0.565
72468653|NCT01473745|144460838|SUPERIORITY_OR_OTHER|||||||0.781|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||nasal width||||0.781
72468654|NCT01473745|144460838|SUPERIORITY_OR_OTHER|||||||0.164|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||alar base width||||0.164
72468655|NCT01473745|144460838|SUPERIORITY_OR_OTHER|||||||0.554|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||R nostril show vertical dimension||||0.554
72468656|NCT01473745|144460838|SUPERIORITY_OR_OTHER|||||||0.508|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||L nostril show vertical dimension||||0.508
72468657|NCT01473745|144460838|SUPERIORITY_OR_OTHER|||||||0.358|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||columellar length||||0.358
72468658|NCT01473745|144460838|SUPERIORITY_OR_OTHER|||||||0.049|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||cutaneous height of upper lip||||0.049
72468659|NCT01473745|144460838|SUPERIORITY_OR_OTHER|||||||0.057|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||overall upper lip height||||0.057
72468660|NCT01473745|144460838|SUPERIORITY_OR_OTHER|||||||0.062|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||vermillion height of upper lip||||0.062
72468661|NCT01473745|144460838|SUPERIORITY_OR_OTHER|||||||0.029|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||lower prolabial width||||0.029
72468662|NCT01473745|144460838|SUPERIORITY_OR_OTHER|||||||0.011|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||upper lip protrusion||||0.011
72468663|NCT01473745|144460838|SUPERIORITY_OR_OTHER|||||||0.211|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||intercanthal distance||||0.211
72468664|NCT01473745|144460838|SUPERIORITY_OR_OTHER|||||||0.102|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||nasal height||||0.102
72468665|NCT01473745|144460838|SUPERIORITY_OR_OTHER|||||||0.136|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||nasal length||||0.136
72468666|NCT01473745|144460838|SUPERIORITY_OR_OTHER|||||||0.113|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||nasal tip protrusion||||0.113
72468667|NCT01473745|144460838|SUPERIORITY_OR_OTHER|||||||0.115|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||nasal width||||0.115
72468668|NCT01473745|144460838|SUPERIORITY_OR_OTHER|||||||0.535|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||alar base width||||0.535
72468669|NCT01473745|144460838|SUPERIORITY_OR_OTHER|||||||0.85|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||R nostril show vertical dimension||||0.850
72468670|NCT01473745|144460838|SUPERIORITY_OR_OTHER|||||||0.891|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||L nostril show vertical dimension||||0.891
72468671|NCT01473745|144460838|SUPERIORITY_OR_OTHER|||||||0.262|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||columellar length||||0.262
72468672|NCT01473745|144460838|SUPERIORITY_OR_OTHER|||||||0.344|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||cutaneous height of upper lip||||0.344
72622050|NCT04003142|144774320|SUPERIORITY|||||||0.049|||||||Hochberg|||||||0.049
72622051|NCT04003142|144774320|SUPERIORITY||||||<|0.001|||||||Hochberg|||||||<0.001
72565051|NCT00562120|144661738|SUPERIORITY_OR_OTHER|||||||0.156|TWO_SIDED|||||P-value was based on two-sided test which was underpowered and presented for descriptive purposes only. There were no further adjustments for multiplicity.|ANOVA|||An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||||0.156
72565052|NCT00562120|144661738|SUPERIORITY_OR_OTHER|||||||0.848|TWO_SIDED|||||P-value was based on two-sided test which was underpowered and presented for descriptive purposes only. There were no further adjustments for multiplicity.|ANOVA|||An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||||0.848
72468673|NCT01473745|144460838|SUPERIORITY_OR_OTHER|||||||0.057|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||overall upper lip height||||0.057
72565053|NCT00595335|144661759|SUPERIORITY_OR_OTHER|||||||0.73|||||||t-test, 2 sided|||Comparison of the change between the two groups' CAS score at 6 months.||||0.73
72565054|NCT00595335|144661760|SUPERIORITY_OR_OTHER|||||||0.75|||||||Fisher Exact|||Comparison of the change between the two groups' failure rate at 6 months.||||0.75
72565055|NCT00595335|144661760|SUPERIORITY_OR_OTHER|||||||0.85|||||||Fisher Exact|||Comparison of the change between the two groups' failure rate at 12 months.||||0.85
72565056|NCT00595335|144661762|SUPERIORITY_OR_OTHER|||||||0.97|||||||t-test, 2 sided|||Comparison of the change between the two groups in proptosis in the right eye at 12 months.||||0.97
72565057|NCT00595335|144661762|SUPERIORITY_OR_OTHER|||||||0.86|||||||t-test, 2 sided|||Comparison of the change between the two groups in change in proptosis in left eye at 12 months.||||0.86
72565058|NCT00595335|144661763|SUPERIORITY_OR_OTHER|||||||0.98|||||||t-test, 2 sided|||Comparison of the change in lid fissure in the right eye between the two groups.||||0.98
72565059|NCT00595335|144661763|SUPERIORITY_OR_OTHER|||||||0.49|||||||t-test, 2 sided|||Comparison of the change in lid fissure in the left eye between the two groups.||||0.49
72565060|NCT00595335|144661764|SUPERIORITY_OR_OTHER|||||||0.21|||||||t-test, 2 sided|||Comparison of change between groups in extraocular motility at 6 months.||||0.21
72565061|NCT00595335|144661764|SUPERIORITY_OR_OTHER|||||||0.64|||||||t-test, 2 sided|||Comparison of change between groups in extraocular motility at 12 months.||||0.64
72565062|NCT00595335|144661765|SUPERIORITY_OR_OTHER|||||||0.36|||||||t-test, 2 sided|||Comparison of the arms for QoL SF-12 physical score at 6 months.||||0.36
72565063|NCT00595335|144661765|SUPERIORITY_OR_OTHER|||||||0.91|||||||t-test, 2 sided|||Comparison of the arms for QoL SF-12 mental score at 6 months.||||0.91
72565064|NCT00595335|144661765|SUPERIORITY_OR_OTHER|||||||0.29|||||||t-test, 2 sided|||Comparison of the arms for QoL SF-12 physical score at 12 months.||||0.29
72565065|NCT00595335|144661765|SUPERIORITY_OR_OTHER|||||||0.18|||||||t-test, 2 sided|||Comparison of the arms for QoL SF-12 mental score at 12 months.||||0.18
72565066|NCT00595335|144661766|SUPERIORITY_OR_OTHER|||||||0.85|||||||Fisher Exact|||Comparison of the change between the two groups' failure rate at 12 months.||||0.85
72565067|NCT01131299|144661803|SUPERIORITY_OR_OTHER|||||||0.82|||||||t-test, 2 sided|||The minimum sample size to detect an 8 mg/dl change in total plasma cholesterol between the placebo and alpha cyclodextrin periods is 62 subjects. The power is 80% by using the normal approximation to a one-sample (paired) two-tail t-test at an alpha of 0.05.||||0.82
72565068|NCT01131299|144661804|SUPERIORITY_OR_OTHER|||||||0.04|||||||t-test, 2 sided|||||||0.04
72565069|NCT01131299|144661805|SUPERIORITY_OR_OTHER|||||||0.05|||||||t-test, 2 sided|||||||0.05
72565070|NCT01131299|144661806|SUPERIORITY_OR_OTHER|||||||0.04|||||||t-test, 2 sided|||||||0.04
72565071|NCT03686150|144661812|OTHER|This was a population PK analysis of 25(OH)D after oral administration of Vitamin D.||||||||||||||||Part 1 of this study was to perform a population PK analysis of 25(OH)D after oral administration of Vitamin D in children who are overweight or obese and have asthma. Based on the interim analysis of the VDORA study, the PK of 25(OH)D after Vitamin D supplementation in children was well characterized by a 2-compartment population PK model with linear absorption and elimination kinetics. A loading dose of 50,000 IU followed by a daily dose of 8,000 IU was recommended.|Based on the interim analysis of the VDORA study, the PK of 25(OH)D after Vitamin D supplementation in children was well characterized by a 2-compartment population PK model with linear absorption and elimination kinetics. A loading dose of 50,000 IU followed by a daily dose of 8,000 IU was recommended.|||
72565072|NCT03686150|144661813|OTHER|This is one-sample test of proportion testing the null hypothesis that the proportion of participants with 25(OH)D level \>= 40 ng/mL is 50%.||||||0.0001|||||||z-test|||This is a one-sample test of proportion.||||0.0001
72565073|NCT03694808|144661814|NON_INFERIORITY|Ratio of GMT (Fluzone/Fluad), upper bound of two-sided 95% CI should not exceed 1.5 for non-inferiority|ratio of GMT (Fluzone/Fluad)|1.23|||||TWO_SIDED|95.0|0.8|1.89|||t-test, 2 sided|||Statistical Analysis for Year 1 (2018-2019)||1.89|0.8|
72565074|NCT03694808|144661814|NON_INFERIORITY|Ratio of GMT (Fluzone/Fluad), upper bound of two-sided 95% CI should not exceed 1.5 for non-inferiority|Ratio of GMT (Fluzone/Fluad)|0.95|||||TWO_SIDED|95.0|0.66|1.38|||t-test, 2 sided|||Statistical Analysis for Year 2 (2019-2020)||1.38|0.66|
72565075|NCT03694808|144661815|NON_INFERIORITY|Ratio of GMT (Fluzone/Fluad), upper bound of two-sided 95% CI should not exceed 1.5 for non-inferiority|Ratio of GMT (Fluzone/Fluad)|1.38|||||TWO_SIDED|95.0|0.88|2.15|||t-test, 2 sided|||Statistical Analysis for Year 1 (2018-2019)||2.15|0.88|
72565076|NCT03694808|144661815|NON_INFERIORITY|Ratio of GMT (Fluzone/Fluad), upper bound of two-sided 95% CI should not exceed 1.5 for non-inferiority|Ratio of GMT (Fluzone/Fluad)|0.86|||||TWO_SIDED|95.0|0.53|1.4|||t-test, 2 sided|||Statistical Analysis for Year 2 (2019-2020)||1.4|0.53|
72565077|NCT03694808|144661816|NON_INFERIORITY|Ratio of GMT (Fluzone/Fluad), upper bound of two-sided 95% CI should not exceed 1.5 for non-inferiority|Ratio of GMT (Fluzone/Fluad)|1.85|||||TWO_SIDED|95.0|1.23|2.79|||t-test, 2 sided|||Statistical Analysis Year 1 (2018-2019)||2.79|1.23|
72565078|NCT03694808|144661816|NON_INFERIORITY|2-sided t-test performed on log-transformed titers; estimate and 95% confidence interval of log-scale difference exponentiated to generate GMT ratio and its 95% CI below.|Ratio of GMT (Fluzone/Fluad)|0.88|||||TWO_SIDED|95.0|0.61|1.26|||t-test, 2 sided|||Statistical Analysis Year 2 (2019-2020)||1.26|0.61|
72468674|NCT01473745|144460838|SUPERIORITY_OR_OTHER|||||||0.995|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||vermillion height of upper lip||||0.995
72468675|NCT01473745|144460838|SUPERIORITY_OR_OTHER|||||||0.44|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||lower prolabial width||||0.440
72468676|NCT01473745|144460838|SUPERIORITY_OR_OTHER|||||||0.078|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||upper lip protrusion||||0.078
72468677|NCT01473745|144460839|SUPERIORITY_OR_OTHER|||||||0.104|TWO_SIDED|||||intergroup difference of conventional group|t-test, 2 sided|P value \< 0.05 was set as statistical significance.||||||0.104
72468678|NCT01473745|144460839|SUPERIORITY_OR_OTHER|||||||0.043|TWO_SIDED|||||Intergroup difference of modified group|t-test, 2 sided|P value \<0.05 was set as statistical significance.||||||0.043
72468679|NCT01473745|144460839|SUPERIORITY_OR_OTHER|||||||0.888|TWO_SIDED||||||t-test, 2 sided|P value \< 0.05 was set as statistical significance.||||||0.888
72468680|NCT02366143|144460853|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.62|||<|0.0001|TWO_SIDED|95.0|0.52|0.74|||Log Rank|||ITT-WT population||0.74|0.52|<0.0001
72504205|NCT01025336|144539194|SUPERIORITY_OR_OTHER||Ratio of GMT|1.4|||||TWO_SIDED|95.0|0.85|2.32|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/13vPnC - 13vPnC/23vPS)\]|Serotype 6A: Ratio of GMT (13vPnC/13vPnC to 13vPnC/23vPS) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale.||2.32|0.85|
72504206|NCT01025336|144539194|SUPERIORITY_OR_OTHER||Ratio of GMT|1.3|||||TWO_SIDED|95.0|0.82|2.13|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/13vPnC - 13vPnC/23vPS)\]|Serotype 6B: Ratio of GMT (13vPnC/13vPnC to 13vPnC/23vPS) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale.||2.13|0.82|
72565079|NCT03694808|144661817|NON_INFERIORITY|Difference between seroconversion rates (Fluzone - Fluad), upper bound of two-sided 95% CI of difference should not exceed 10 percentage points for non-inferiority|Difference in proportions|0.154|||||TWO_SIDED|95.0|-0.001|0.308|||Test of proportions|2sided proportions test to estimate 95% CI difference in seroconversion rates; upper limit differences compared to 10%, per non-inferiority guidance||Statistical Analysis Year 1 (2018-2019)||0.308|-0.001|
72565080|NCT03694808|144661817|NON_INFERIORITY|Difference between seroconversion rates (Fluzone - Fluad), upper bound of two-sided 95% CI of difference should not exceed 10 percentage points for non-inferiority|Difference in proportions|-0.056|||||TWO_SIDED|95.0|-0.2|0.089|||Test of proportions|2sided proportions test to estimate 95% CI difference in seroconversion rates; upper limit differences compared to 10%, per non-inferiority guidance||Statistical Analysis Year 2 (2019-2020)||0.089|-0.2|
72565081|NCT03694808|144661818|NON_INFERIORITY|Difference between seroconversion rates (Fluzone - Fluad), upper bound of two-sided 95% CI of difference should not exceed 10 percentage points for non-inferiority|Difference in proportions|0.218|||||TWO_SIDED|95.0|0.063|0.373|||Test of proportions|2sided proportions test to estimate 95% CI difference in seroconversion rates; upper limit differences compared to 10%, per non-inferiority guidance||Statistical Analysis Year 1 (2018-2019)||0.373|0.063|
72468681|NCT02366143|144460853|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.51|||<|0.0001|TWO_SIDED|95.0|0.38|0.68|||Log Rank|||Teff-high WT Population||0.68|0.38|<0.0001
72468682|NCT02366143|144460854|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.78||||0.0164|TWO_SIDED|95.0|0.64|0.96|||Log Rank|||||0.96|0.64|0.0164
72468683|NCT02366143|144460855|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.842||||0.0528|TWO_SIDED|95.0|0.707|1.002|||Log Rank|||||1.002|0.707|0.0528
72468684|NCT02366143|144460856|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.71||||0.0002|TWO_SIDED|95.0|0.59|0.85|||Log Rank|||ITT-WT population||0.85|0.59|0.0002
72468685|NCT02366143|144460856|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.564||||0.0001|TWO_SIDED|95.0|0.418|0.76|||Log Rank|||Teff-high WT Population||0.760|0.418|0.0001
72468686|NCT02366143|144460857|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.492|||<|0.0001|TWO_SIDED|95.0|0.374|0.649|||Log Rank|||Teff-high Population||0.649|0.374|<.0001
72468687|NCT02366143|144460857|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.61|||<|0.0001|TWO_SIDED|95.0|0.517|0.72|||Log Rank|||ITT Population||0.720|0.517|<.0001
72468688|NCT02366143|144460859|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.471|||<|0.0001|TWO_SIDED|95.0|0.352|0.647|||Log Rank|||TC2/3 or IC2/3 Subgroup||0.647|0.352|<.0001
72468689|NCT02366143|144460859|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.486|||<|0.0001|TWO_SIDED|95.0|0.386|0.639|||Log Rank|||TC1/2/3 or IC1/2/3 Subgroup||0.639|0.386|<.0001
72468690|NCT02366143|144460860|SUPERIORITY|Unstratified Analysis|Hazard Ratio (HR)|0.824||||0.2765|TWO_SIDED|95.0|0.58|1.169|||Log Rank|||TC2/3 or IC2/3, WT ITT||1.169|0.580|0.2765
72468691|NCT02366143|144460860|SUPERIORITY|Unstratified Analysis|Hazard Ratio (HR)|0.771||||0.0829|TWO_SIDED|95.0|0.575|1.035|||Log Rank|||TC1/2/3 or IC1/2/3, WT ITT||1.035|0.575|0.0829
72468692|NCT02366143|144460861|SUPERIORITY|Unstratified Analysis|Hazard Ratio (HR)|0.709||||0.0073|TWO_SIDED|95.0|0.551|0.913|||Log Rank|||TC1/2/3 or IC1/2/3 ITT-WT||0.913|0.551|0.0073
72468693|NCT02366143|144460861|SUPERIORITY|Unstratified Analysis|Hazard Ratio (HR)|0.662||||0.0097|TWO_SIDED|95.0|0.484|0.907|||Log Rank|||TC2/3 or IC2/3 Population||0.907|0.484|0.0097
72468694|NCT02366143|144460862|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.831||||0.2843|TWO_SIDED|95.0|0.592|1.167|||Log Rank|||Teff high-WT||1.167|0.592|0.2843
72468695|NCT02366143|144460862|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.802||||0.1861|TWO_SIDED|95.0|0.579|1.113|||Log Rank|||Teff high||1.113|0.579|0.1861
72468696|NCT02366143|144460862|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.764||||0.006|TWO_SIDED|95.0|0.63|0.926|||Log Rank|||ITT||0.926|0.630|0.0060
72504207|NCT01025336|144539194|SUPERIORITY_OR_OTHER||Ratio of GMT|0.6|||||TWO_SIDED|95.0|0.37|0.97|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/13vPnC - 13vPnC/23vPS)\]|Serotype 7F: Ratio of GMT (13vPnC/13vPnC to 13vPnC/23vPS) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale.||0.97|0.37|
72622052|NCT04003142|144774321|SUPERIORITY||LSMean difference|-0.7|STANDARD_ERROR_OF_MEAN|0.7||0.381|TWO_SIDED|95.0|-2.1|0.8||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||||0.8|-2.1|0.381
72394741|NCT01979016|144296008|SUPERIORITY||Percentage difference|48.1|||=|0.0002|TWO_SIDED|95.0|27.0|69.3|||Cochran-Mantel-Haenszel|||Statistical comparison for percentage of participants who achieved 50% reduction from baseline in SCORAD Score (SCORAD-50). Analysis was performed by a MMRM model.||69.3|27.0|= 0.0002
72394742|NCT01979016|144296008|SUPERIORITY||Percentage difference|11.1|||=|0.0792|TWO_SIDED|95.0|-0.7|23.0|||Cochran-Mantel-Haenszel|||Statistical comparison for percentage of participants who achieved 75% reduction from baseline in SCORAD Score (SCORAD-75). Analysis was performed by a MMRM model.||23.0|-0.7|= 0.0792
72394743|NCT01979016|144296008|SUPERIORITY||Percentage difference|7.4|||=|0.1573|TWO_SIDED|95.0|-2.5|17.3|||Cochran-Mantel-Haenszel|||Statistical comparison for percentage of participants who achieved 90% reduction from baseline in SCORAD Score (SCORAD-90). Analysis was performed by a MMRM model.||17.3|-2.5|= 0.1573
72468697|NCT02366143|144460863|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.786||||0.0894|TWO_SIDED|95.0|0.595|1.038|||Log Rank|||Teff high-WT||1.038|0.595|0.0894
72468698|NCT02366143|144460863|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.815||||0.1276|TWO_SIDED|95.0|0.626|1.061|||Log Rank|||Teff high||1.061|0.626|0.1276
72468699|NCT02366143|144460863|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.861||||0.0681|TWO_SIDED|95.0|0.733|1.011|||Log Rank|||ITT||1.011|0.733|0.0681
72468700|NCT02366143|144460864|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.901||||0.4599|TWO_SIDED|95.0|0.683|1.188|||Log Rank|||Teff high-WT ITT||1.188|0.683|0.4599
72468701|NCT02366143|144460865|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.523|||<|0.0001|TWO_SIDED|95.0|0.406|0.675|||Log Rank|||ITT-WT||0.675|0.406|<.0001
72468702|NCT02366143|144460865|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.42|||<|0.0001|TWO_SIDED|95.0|0.283|0.624|||Log Rank|||Teff-high WT||0.624|0.283|<.0001
72468703|NCT02366143|144460867|SUPERIORITY|Stratified Analysis|Difference in Event Free Rate|6.68||||0.0697|TWO_SIDED|95.0|-0.54|13.9|||Z-test|||1-Year ITT-WT Population||13.90|-0.54|0.0697
72468704|NCT02366143|144460867|SUPERIORITY|Stratified Analysis|Difference in Event Free Rate|9.71||||0.0347|TWO_SIDED|95.0|0.7|18.73|||Z-test|||2-Year ITT-WT Population||18.73|0.70|0.0347
72468705|NCT02366143|144460867|SUPERIORITY|Stratified Analysis|Difference in Event Free Rate|9.89||||0.089|TWO_SIDED|95.0|-1.51|21.29|||Z-test|||1-Year Teff-high WT Population||21.29|-1.51|0.0890
72468706|NCT02366143|144460867|OTHER|Stratified Analysis|Difference in Event Free Rate|10.34||||0.1336|TWO_SIDED|95.0|-3.17|23.84|||Z-test|||2-Year Teff-high WT Population||23.84|-3.17|0.1336
72468707|NCT02366143|144460868|SUPERIORITY|Stratified Analysis|Difference in Event Free Rate|4.18||||0.2624|TWO_SIDED|95.0|-3.13|11.48|||Z-test|||1-Year ITT-WT Population||11.48|-3.13|0.2624
72565082|NCT03694808|144661818|NON_INFERIORITY|Difference between seroconversion rates (Fluzone - Fluad), upper bound of two-sided 95% CI of difference should not exceed 10 percentage points for non-inferiority|Difference in proportions|-0.008|||||TWO_SIDED|95.0|-0.139|0.123|||Test of proportions|2sided proportions test to estimate 95% CI difference in seroconversion rates; upper limit differences compared to 10%, per non-inferiority guidance||Statistical Analysis Year 2 (2019-2020)||0.123|-0.139|
72394744|NCT01979016|144296009|SUPERIORITY||LS Mean Difference|-10.4|||<|0.0001|TWO_SIDED|95.0|-14.3|-6.6|||ANCOVA|||Analysis was performed by a MMRM model.||-6.6|-14.3|< 0.0001
72394745|NCT01979016|144296010|SUPERIORITY||LS Mean Difference|-46.2|||<|0.0001|TWO_SIDED|95.0|-63.9|-28.5|||ANCOVA|||Analysis was performed by a MMRM model.||-28.5|-63.9|< 0.0001
72394746|NCT01979016|144296012|SUPERIORITY||LS Mean Difference|-3.7|||<|0.0001|TWO_SIDED|95.0|-5.02|-2.39|||ANCOVA|||||-2.39|-5.02|< 0.0001
72394747|NCT03765918|144296069|OTHER|Difference in percentage (calculated as % Pembrolizumab + SOC arm - % SOC arm) and 95% CI were based on Miettinen \& Nurminen method stratified by primary tumor site and tumor stage.|Difference in Percentage|9.3|||<|1e-05|TWO_SIDED|95.0|6.7|12.8||One-sided p-value for testing. H0: difference in % = 0 versus H1: difference in % \> 0.|Stratified Miettinen and Nurminen|||||12.8|6.7|<0.00001
72468708|NCT02366143|144460868|SUPERIORITY|Stratified Analysis|Difference in Event Free Rate|9.67||||0.0088|TWO_SIDED|95.0|2.43|16.9|||Z-test|||2-Year ITT-WT Population||16.90|2.43|0.0088
72468709|NCT02366143|144460868|SUPERIORITY|Stratified Analysis|Difference in Event Free Rate|10.56||||0.0649|TWO_SIDED|95.0|-0.65|21.77|||Z-test|||1-Year Teff-high WT Population||21.77|-0.65|0.0649
72468710|NCT02366143|144460868|SUPERIORITY|Stratified Analysis|Difference in Event Free Rate|7.27||||0.212|TWO_SIDED|95.0|-4.15|18.69|||Z-test|||2-Year Teff-high WT Population||18.69|-4.15|0.2120
72468711|NCT02366143|144460869|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.909||||0.6899|TWO_SIDED|95.0|0.571|1.45|||Log Rank|||Teff-high WT Population||1.450|0.571|0.6899
72468712|NCT02366143|144460869|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.671||||0.1043|TWO_SIDED|95.0|0.413|1.089|||Log Rank|||Teff-high WT Population||1.089|0.413|0.1043
72468713|NCT02366143|144460869|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|1.232||||0.173||95.0|0.912|1.665|||Log Rank|||ITT WT||1.665|0.912|0.1730
72468714|NCT02366143|144460869|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|1.084||||0.6145|TWO_SIDED|95.0|0.792|1.483|||Log Rank|||ITT WT||1.483|0.792|0.6145
72468715|NCT02366143|144460870|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|1.041||||0.8816|TWO_SIDED|95.0|0.614|1.763|||Log Rank|||Cough for Teff-high WT ITT population||1.763|0.614|0.8816
72468716|NCT02366143|144460870|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.741||||0.2995|TWO_SIDED|95.0|0.419|1.309|||Log Rank|||Cough for Teff-high WT ITT Population||1.309|0.419|0.2995
72468717|NCT02366143|144460870|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.936||||0.7578|TWO_SIDED|95.0|0.616|1.422|||Log Rank|||Dyspnea in Teff-high WT Population||1.422|0.616|0.7578
72468718|NCT02366143|144460870|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|1.041||||0.847|TWO_SIDED|95.0|0.694|1.56|||Log Rank|||Dyspnea in Teff-high WT Population||1.560|0.694|0.8470
72468719|NCT02366143|144460870|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.659||||0.1289|TWO_SIDED|95.0|0.383|1.133|||Log Rank|||Pain in Chest in Teff-high WT Population||1.133|0.383|0.1289
72565083|NCT03694808|144661819|NON_INFERIORITY|Difference between seroconversion rates (Fluzone - Fluad), upper bound of two-sided 95% CI of difference should not exceed 10 percentage points for non-inferiority|Difference in proportions|0.136|||||TWO_SIDED|95.0|-0.019|0.291|||Test of proportions|2sided proportions test to estimate 95% CI difference in seroconversion rates; upper limit differences compared to 10%, per non-inferiority guidance||Statistical Analysis Year 1 (2018-2019)||0.291|-0.019|
72468720|NCT02366143|144460870|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.729||||0.2381|TWO_SIDED|95.0|0.43|1.235|||Log Rank|||Pain in Chest in Teff-high WT Population||1.235|0.430|0.2381
72468721|NCT02366143|144460870|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|1.09||||0.7163|TWO_SIDED|95.0|0.685|1.732|||Log Rank|||Arm and/or Shoulder Pain in Teff-high WT||1.732|0.685|0.7163
72468722|NCT02366143|144460870|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.693||||0.1502|TWO_SIDED|95.0|0.42|1.145|||Log Rank|||Arm and/or Shoulder Pain in Teff-high WT||1.145|0.420|0.1502
72468723|NCT02366143|144460870|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|1.01||||0.9568|TWO_SIDED|95.0|0.713|1.43|||Log Rank|||Cough in ITT-WT Population||1.430|0.713|0.9568
72468724|NCT02366143|144460870|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.891||||0.5377|TWO_SIDED|95.0|0.619|1.284|||Log Rank|||Cough in ITT-WT Population||1.284|0.619|0.5377
72468725|NCT02366143|144460870|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.893||||0.4012|TWO_SIDED|95.0|0.685|1.163|||Log Rank|||Dyspnea in ITT-WT Population||1.163|0.685|0.4012
72468726|NCT02366143|144460870|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|1.05||||0.7149|TWO_SIDED|95.0|0.809|1.363|||Log Rank|||Dyspnea in ITT-WT Population||1.363|0.809|0.7149
72468727|NCT02366143|144460870|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|1.057||||0.7126|TWO_SIDED|95.0|0.786|1.422|||Log Rank|||Arm and/or Shoulder Pain in ITT-WT||1.422|0.786|0.7126
72468728|NCT02366143|144460870|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.921||||0.6053|TWO_SIDED|95.0|0.675|1.258|||Log Rank|||Arm and/or Shoulder Pain in ITT-WT||1.258|0.675|0.6053
72468729|NCT02366143|144460870|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.829||||0.3134|TWO_SIDED|95.0|0.576|1.194|||Log Rank|||Pain in Chest in ITT-WT Population||1.194|0.576|0.3134
72468730|NCT02366143|144460870|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.91||||0.6115|TWO_SIDED|95.0|0.633|1.309|||Log Rank|||Pain in Chest in ITT-WT Population||1.309|0.633|0.6115
72468731|NCT03898700|144460888|OTHER||Median Difference (Final Values)|2.0|||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||This one-group feasibility study examined outcomes of coaching using descriptive statistics (changed score) and the Wilcoxon signed-rank test. A changed score of 2 points reflects clinical significance. The Wilcoxon was used to determine statistical significance. Performance scores from 31 coaching goals across 7 informal caregivers were used for analysis.||||<0.001
72468732|NCT03898700|144460888|OTHER||Median Difference (Net)|2.0|||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||This one-group feasibility study examined outcomes of coaching using descriptive statistics (changed score) and the Wilcoxon signed-rank test. A changed score of 2 points reflects clinical significance. The Wilcoxon was used to determine statistical significance. Satisfaction scores from 31 coaching goals across 7 informal caregivers were used for analysis.||||<0.001
72468733|NCT00158197|144460891|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.98|||<|0.01|TWO_SIDED||||||Generalized estimating equations||Value represents the odds of submitting a methamphetamine negative urine sample in the treatment group (1 of 3) compared to the standard care group.|||||<0.01
72468734|NCT00158197|144460891|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.4|||<|0.01|||||||Generalized estimating equations||Value represents the odds of submitting a methamphetamine negative urine sample in the treatment group (1 of 3) compared to the standard care group.|||||<0.01
72468735|NCT00158197|144460891|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.72|||<|0.01|||||||Generalized estimating equations||Value represents the odds of submitting a methamphetamine negative urine sample in the treatment group (1 of 3) compared to the standard care group.|||||<0.01
72565084|NCT03694808|144661819|NON_INFERIORITY|Difference between seroconversion rates (Fluzone - Fluad), upper bound of two-sided 95% CI of difference should not exceed 10 percentage points for non-inferiority|Difference in proportions|0.024|||||TWO_SIDED|95.0|-0.117|0.164|||Test of proportions|2sided proportions test to estimate 95% CI difference in seroconversion rates; upper limit differences compared to 10%, per non-inferiority guidance||Statistical Analysis Year 2 (2019-2020)||0.164|-0.117|
72565085|NCT03694808|144661820|NON_INFERIORITY|Ratio of GMT (Fluzone/Fluad), upper bound of two-sided 95% CI should not exceed 1.5 for non-inferiority|Ratio of GMT (Fluzone/Fluad)|0.43|||||TWO_SIDED|95.0|0.29|0.64|||t-test, 2 sided|||Statistical Analysis Year 1 (2018-2019)||0.64|0.29|
72565086|NCT03694808|144661820|NON_INFERIORITY|Ratio of GMT (Fluzone/Fluad), upper bound of two-sided 95% CI should not exceed 1.5 for non-inferiority|Ratio of GMT (Fluzone/Fluad)|0.45|||||TWO_SIDED|95.0|0.29|0.69|||t-test, 2 sided|||Statistical Analysis Year 2 (2019-2020)||0.69|0.29|
72468736|NCT00158197|144460892|SUPERIORITY_OR_OTHER|||||||0.02||||||Yes, the a priori plan to handle post hoc multiple comparisons was to use the method of Bonferroni adjustment. Thus, the new alpha level for these comparisons was \<0.0125.|ANOVA|||||||0.02
72468737|NCT00158197|144460892|SUPERIORITY_OR_OTHER||||||<|0.01|||||||t-test, 2 sided|||||||<0.01
72468738|NCT00158197|144460892|SUPERIORITY_OR_OTHER||||||<|0.01|||||||t-test, 2 sided|||||||<0.01
72468739|NCT00158197|144460892|SUPERIORITY_OR_OTHER|||||||0.2|||||||t-test, 2 sided|||||||0.20
72468740|NCT00158197|144460893|SUPERIORITY_OR_OTHER|||||||0.78|||||||Generalized estimating equations|||We used GEE to investigate change in methamphetamine abstinence (i.e., provision of a negative methamphetamine UA) during the follow-up period.||||0.78
72468741|NCT00158197|144460893|SUPERIORITY_OR_OTHER|||||||0.68|||||||Generalized estimating equations|||We used GEE to investigate change in methamphetamine abstinence (i.e., provision of a negative methamphetamine UA) during the follow-up period.||||0.68
72468742|NCT00158197|144460893|SUPERIORITY_OR_OTHER|||||||0.2|||||||Generalized estimating equations|||We used GEE to investigate change in methamphetamine abstinence (i.e., provision of a negative methamphetamine UA) during the follow-up period.||||0.20
72468743|NCT02666664|144460910|SUPERIORITY||Difference in LS mean|-18.1|STANDARD_ERROR_OF_MEAN|1.01|<|0.001|TWO_SIDED|95.0|-20.0|-16.1|||ANCOVA|||||-16.1|-20|<0.001
72565087|NCT03694808|144661821|NON_INFERIORITY|Ratio of GMT (Fluzone/Fluad), upper bound of two-sided 95% CI should not exceed 1.5 for non-inferiority|Ratio of GMT (Fluzone/Fluad)|0.91|||||TWO_SIDED|95.0|0.71|1.16|||t-test, 2 sided|||Statistical Analysis Year 1 (2018-2019)||1.16|0.71|
72565088|NCT03694808|144661821|NON_INFERIORITY|Ratio of GMT (Fluzone/Fluad), upper bound of two-sided 95% CI should not exceed 1.5 for non-inferiority|Ratio of GMT (Fluzone/Fluad)|0.96|||||TWO_SIDED|95.0|0.69|1.33|||t-test, 2 sided|||Statistical Analysis Year 2 (2019-2020)||1.33|0.69|
72468744|NCT02666664|144460912|SUPERIORITY||Difference in LS mean|-16.1|STANDARD_ERROR_OF_MEAN|1.07|<|0.001|TWO_SIDED|95.0|-18.2|-14.0|||ANCOVA|||||-14|-18.2|<0.001
72468745|NCT02666664|144460913|SUPERIORITY||Difference in LS mean|-13.3|STANDARD_ERROR_OF_MEAN|0.9|<|0.001|TWO_SIDED|95.0|-15.1|-11.6|||ANCOVA|||||-11.6|-15.1|<0.001
72468746|NCT02666664|144460914|SUPERIORITY||Difference in LS mean|-11.1|STANDARD_ERROR_OF_MEAN|0.69|<|0.001|TWO_SIDED|95.0|-12.5|-9.8|||ANCOVA|||||-9.8|-12.5|<0.001
72504208|NCT01025336|144539194|SUPERIORITY_OR_OTHER||Ratio of GMT|1.0|||||TWO_SIDED|95.0|0.54|1.7|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/13vPnC - 13vPnC/23vPS)\]|Serotype 9V: Ratio of GMT (13vPnC/13vPnC to 13vPnC/23vPS) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale.||1.70|0.54|
72504209|NCT01025336|144539194|SUPERIORITY_OR_OTHER||Ratio of GMT|0.9|||||TWO_SIDED|95.0|0.59|1.41|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/13vPnC - 13vPnC/23vPS)\]|Serotype 14: Ratio of GMT (13vPnC/13vPnC to 13vPnC/23vPS) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale.||1.41|0.59|
72565089|NCT03694808|144661822|NON_INFERIORITY|Difference between seroconversion rates (Fluzone - Fluad), upper bound of two-sided 95% CI of difference should not exceed 10 percentage points for non-inferiority|Difference in proportions|-0.544|||||TWO_SIDED|95.0|-0.674|-0.414|||Test of proportions|2sided proportions test to estimate 95% CI difference in seroconversion rates; upper limit differences compared to 10%, per non-inferiority guidance||Statistical Analysis Year 1 (2018-2019)||-0.414|-0.674|
72468747|NCT02666664|144460915|SUPERIORITY||Difference in LS mean|-11.9|STANDARD_ERROR_OF_MEAN|0.85|<|0.001|TWO_SIDED|95.0|-13.6|-10.2|||ANCOVA|||||-10.2|-13.6|<0.001
72468748|NCT02666664|144460916|SUPERIORITY||Location shift|-21.5|STANDARD_ERROR_OF_MEAN|2.8|<|0.001|TWO_SIDED|95.0|-26.96|-16.0|||Wilcoxon (Mann-Whitney)|||||-16|-26.96|<0.001
72468749|NCT02666664|144460917|SUPERIORITY||Difference in LS mean|-13.6|STANDARD_ERROR_OF_MEAN|1.13|<|0.001|TWO_SIDED|95.0|-15.8|-11.3|||ANCOVA|||||-11.3|-15.8|<0.001
72468750|NCT02666664|144460926|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
72468751|NCT03616964|144460927|SUPERIORITY||Odds Ratio (OR)|1.07||||0.711|TWO_SIDED|95.0|0.75|1.53|||Regression, Logistic|||||1.53|0.75|0.711
72468752|NCT03616964|144460928|SUPERIORITY||Odds Ratio (OR)|1.05||||0.789|TWO_SIDED|95.0|0.73|1.5|||Regression, Logistic|||||1.50|0.73|0.789
72468753|NCT03616964|144460929|SUPERIORITY||Odds Ratio (OR)|1.1||||0.673|TWO_SIDED|95.0|0.72|1.68|||Regression, Logistic|||||1.68|0.72|0.673
72468754|NCT03616964|144460929|SUPERIORITY||Odds Ratio (OR)|1.15||||0.528|TWO_SIDED|95.0|0.75|1.75|||Regression, Logistic|||||1.75|0.75|0.528
72468755|NCT03616964|144460931|SUPERIORITY||Odds Ratio (OR)|0.91||||0.761|TWO_SIDED|95.0|0.51|1.64|||Regression, Logistic|||||1.64|0.51|0.761
72565090|NCT03694808|144661822|NON_INFERIORITY|Difference between seroconversion rates (Fluzone - Fluad), upper bound of two-sided 95% CI of difference should not exceed 10 percentage points for non-inferiority|Difference in proportions|-0.168|||||TWO_SIDED|95.0|-0.311|-0.025|||Test of proportions|2sided proportions test to estimate 95% CI difference in seroconversion rates; upper limit differences compared to 10%, per non-inferiority guidance||Statistical Analysis Year 2 (2019-2020)||-0.025|-0.311|
72468756|NCT03616964|144460931|SUPERIORITY||Odds Ratio (OR)|1.17||||0.611|TWO_SIDED|95.0|0.65|2.1|||Regression, Logistic|||||2.10|0.65|0.611
72565091|NCT03694808|144661823|NON_INFERIORITY|Difference between seroconversion rates (Fluzone - Fluad), upper bound of two-sided 95% CI of difference should not exceed 10 percentage points for non-inferiority|Difference in proportions|-0.104|||||TWO_SIDED|95.0|-0.221|0.013|||Test of proportions|2sided proportions test to estimate 95% CI difference in seroconversion rates; upper limit differences compared to 10%, per non-inferiority guidance||Statistical Analysis Year 1 (2018-2019)||0.013|-0.221|
72565092|NCT03694808|144661823|NON_INFERIORITY|Difference between seroconversion rates (Fluzone - Fluad), upper bound of two-sided 95% CI of difference should not exceed 10 percentage points for non-inferiority|Difference of proportions|-0.113|||||TWO_SIDED|95.0|-0.241|0.015|||Test of proportions|2sided proportions test to estimate 95% CI difference in seroconversion rates; upper limit differences compared to 10%, per non-inferiority guidance||Statistical Analysis Year 2 (2019-2020)||0.015|-0.241|
72468757|NCT03616964|144460932|SUPERIORITY||LS Mean difference (Final Values)|-0.08|STANDARD_ERROR_OF_MEAN|0.2||0.698|TWO_SIDED|95.0|-0.47|0.32|||Mixed Models Analysis|||||0.32|-0.47|0.698
72468758|NCT03616964|144460932|SUPERIORITY||LS Mean difference (Final Values)|-0.07|STANDARD_ERROR_OF_MEAN|0.2||0.744|TWO_SIDED|95.0|-0.46|0.33|||Mixed Models Analysis|||||0.33|-0.46|0.744
72468759|NCT03616964|144460933|SUPERIORITY||LS Mean difference (Final Values)|-0.36|STANDARD_ERROR_OF_MEAN|0.84||0.665|TWO_SIDED|95.0|-2.0|1.28|||Mixed Models Analysis|||||1.28|-2.00|0.665
72468760|NCT03616964|144460933|SUPERIORITY||LS Mean difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.84||0.723|TWO_SIDED|95.0|-1.95|1.35|||Mixed Models Analysis|||||1.35|-1.95|0.723
72468761|NCT03616964|144460934|SUPERIORITY||Odds Ratio (OR)|0.69||||0.372|TWO_SIDED|95.0|0.31|1.55|||Regression, Logistic|||||1.55|0.31|0.372
72468762|NCT03616964|144460934|SUPERIORITY||Odds Ratio (OR)|0.78||||0.555|TWO_SIDED|95.0|0.34|1.78|||Regression, Logistic|||||1.78|0.34|0.555
72468763|NCT03616964|144460935|SUPERIORITY||LS Mean difference (Final Values)|-0.48|STANDARD_ERROR_OF_MEAN|0.422||0.251|TWO_SIDED|95.0|-1.31|0.34|||Mixed Models Analysis|||||0.34|-1.31|0.251
72468764|NCT03616964|144460935|SUPERIORITY||LS Mean difference (Final Values)|-0.91|STANDARD_ERROR_OF_MEAN|0.425||0.333|TWO_SIDED|95.0|-1.74|-0.07|||Mixed Models Analysis|||||-0.07|-1.74|0.333
72468765|NCT03616964|144460936|SUPERIORITY||LS Mean difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.282||0.284|TWO_SIDED|95.0|-0.86|0.25|||Mixed Models Analysis|||||0.25|-0.86|0.284
72565093|NCT03660241|144661830|OTHER|The ratio and 90% confidence interval were expressed as percentages.|Ratio of adjusted geometric means|138.49|||||TWO_SIDED|90.0|93.74|204.61|||ANOVA|||Test: the moderate renal impairment group; Reference: the normal renal function group.||204.61|93.74|
72565094|NCT03660241|144661830|OTHER|The ratio and 90% confidence interval were expressed as percentages.|Ratio of adjusted geometric means|99.11|||||TWO_SIDED|90.0|57.3|171.43|||ANOVA|||Test: the severe renal impairment group; Reference: the normal renal function group||171.43|57.30|
72565095|NCT03660241|144661831|OTHER|The ratio and 90% confidence interval were expressed as percentages.|Ratio of adjusted geometric means|182.91|||||TWO_SIDED|90.0|117.09|285.71|||ANOVA|||Test: the moderate renal impairment group; Reference: the normal renal function group||285.71|117.09|
72394748|NCT03765918|144296070|OTHER|Difference in percentage (calculated as % Pembrolizumab + SOC arm - % SOC arm) and 95% CI were based on Miettinen \& Nurminen method stratified by primary tumor site and tumor stage.|Difference in Percentage|13.7|||<|1e-05|TWO_SIDED|95.0|9.7|18.7||One-sided p-value for testing. H0: difference in % = 0 versus H1: difference in % \> 0.|Stratified Miettinen and Nurminen|||||18.7|9.7|<0.00001
72394749|NCT03765918|144296071|OTHER|Difference in percentage (calculated as % Pembrolizumab + SOC arm - % SOC arm) and 95% CI were based on Miettinen \& Nurminen method stratified by primary tumor site and tumor stage.|Difference in Percentage|9.8|||<|1e-05|TWO_SIDED|95.0|7.0|13.3||One-sided p-value for testing. H0: difference in % = 0 versus H1: difference in % \> 0.|Stratified Miettinen and Nurminen|||||13.3|7.0|<0.00001
72394750|NCT03765918|144296072|OTHER|Difference in percentage (calculated as % Pembrolizumab + SOC arm - % SOC arm) and 95% CI were based on Miettinen \& Nurminen method stratified by primary tumor site and tumor stage.|Difference in Percentage|3.0||||0.0006|TWO_SIDED|95.0|1.5|5.3||One-sided p-value for testing. H0: difference in % = 0 versus H1: difference in % \> 0.|Stratified Miettinen and Nurminen|||||5.3|1.5|0.0006
72394751|NCT03765918|144296073|OTHER|Difference in percentage (calculated as % Pembrolizumab + SOC arm - % SOC arm) and 95% CI were based on Miettinen \& Nurminen method stratified by primary tumor site and tumor stage.|Difference in Percentage|4.2||||0.0011|TWO_SIDED|95.0|2.1|7.6||One-sided p-value for testing. H0: difference in % = 0 versus H1: difference in % \> 0.|Stratified Miettinen and Nurminen|||||7.6|2.1|0.0011
72394752|NCT03765918|144296074|OTHER|Difference in percentage (calculated as % Pembrolizumab + SOC arm - % SOC arm) and 95% CI were based on Miettinen \& Nurminen method stratified by primary tumor site and tumor stage.|Difference in Percentage|3.1||||0.0006|TWO_SIDED|95.0|1.6|5.6||One-sided p-value for testing. H0: difference in % = 0 versus H1: difference in % \> 0.|Stratified Miettinen and Nurminen|||||5.6|1.6|0.0006
72394753|NCT03765918|144296081|OTHER|Based on a constrained longitudinal data analysis (cLDA) model with the PRO scores as the response variable with covariates for treatment by study visit interaction, and stratification factors by primary tumor site, tumor stage, and PD-L1 status.|Difference in Least Square Means|-1.29||||0.4671|TWO_SIDED|95.0|-4.78|2.2||Two-sided p-value based on cLDA model.|cLDA model|||||2.20|-4.78|0.4671
72394754|NCT03765918|144296082|OTHER|Based on a cLDA model with the PRO scores as the response variable with covariates for treatment by study visit interaction, and stratification factors by primary tumor site, tumor stage, and PD-L1 status.|Difference in Least Square Means|-3.03||||0.1606|TWO_SIDED|95.0|-7.27|1.21||Two-sided p-value based on cLDA model.|cLDA model|||||1.21|-7.27|0.1606
72394755|NCT03765918|144296083|OTHER|Based on a cLDA model with the PRO scores as the response variable with covariates for treatment by study visit interaction, and stratification factors by primary tumor site, tumor stage, and PD-L1 status.|Difference in Least Square Means|-1.41||||0.4374|TWO_SIDED|95.0|-4.96|2.15||Two-sided p-value based on cLDA model.|cLDA model|||||2.15|-4.96|0.4374
72394756|NCT03765918|144296084|OTHER|Based on a cLDA model with the PRO scores as the response variable with covariates for treatment by study visit interaction, and stratification factors by primary tumor site, tumor stage, and PD-L1 status.|Difference in Least Square Means|0.39||||0.8379|TWO_SIDED|95.0|-3.35|4.13||Two-sided p-value based on cLDA model.|cLDA model|||||4.13|-3.35|0.8379
72394757|NCT03765918|144296085|OTHER|Based on a cLDA model with the PRO scores as the response variable with covariates for treatment by study visit interaction, and stratification factors by primary tumor site, tumor stage, and PD-L1 status.|Difference in Least Square Means|-0.39||||0.8643|TWO_SIDED|95.0|-4.84|4.07||Two-sided p-value based on cLDA model.|cLDA model|||||4.07|-4.84|0.8643
72394758|NCT03765918|144296086|OTHER|Based on a cLDA model with the PRO scores as the response variable with covariates for treatment by study visit interaction, and stratification factors by primary tumor site, tumor stage, and PD-L1 status.|Difference in Least Square Means|-0.29||||0.8813|TWO_SIDED|95.0|-4.12|3.54||Two-sided p-value based on cLDA model.|cLDA model|||||3.54|-4.12|0.8813
72565096|NCT03660241|144661831|OTHER|The ratio and 90% confidence interval were expressed as percentages.|Ratio of adjusted geometric means|121.32|||||TWO_SIDED|90.0|68.32|215.41|||ANOVA|||Test: the severe renal impairment group; Reference: the normal renal function group||215.41|68.32|
72394759|NCT03765918|144296093|OTHER|Based on a cLDA model with the PRO scores as the response variable with covariates for treatment by study visit interaction, and stratification factors by primary tumor site, tumor stage, and PD-L1 status.|Difference in Least Square Means|0.34||||0.8287|TWO_SIDED|95.0|-2.76|3.45||Two-sided p-value based on cLDA model.|cLDA model|||||3.45|-2.76|0.8287
72565097|NCT03660241|144661832|OTHER|The ratio and 90% confidence interval were expressed as percentages.|Ratio of adjusted geometric means|99.51|||||TWO_SIDED|90.0|59.8|165.57|||ANOVA|||Test: the moderate renal impairment group; Reference: the normal renal function group||165.57|59.80|
72565098|NCT03660241|144661832|OTHER|The ratio and 90% confidence interval were expressed as percentages.|Ratio of adjusted geometric means|167.79|||||TWO_SIDED|90.0|97.2|289.64|||ANOVA|||Test: the severe renal impairment group; Reference: the normal renal function group||289.64|97.20|
72565099|NCT03660241|144661833|OTHER|The ratio and 90% confidence interval were expressed as percentages.|Ratio of adjusted geometric means|154.22|||||TWO_SIDED|90.0|105.11|226.26|||ANOVA|||Test: the moderate renal impairment group; Reference: the normal renal function group||226.26|105.11|
72565100|NCT03660241|144661833|OTHER|The ratio and 90% confidence interval were expressed as percentages.|Ratio of adjusted geometric means|287.06|||||TWO_SIDED|90.0|196.72|418.89|||ANOVA|||Test: the severe renal impairment group; Reference: the normal renal function group||418.89|196.72|
72565101|NCT03660241|144661834|OTHER|The ratio and 90% confidence interval were expressed as percentages.|Ratio of adjusted geometric means|137.43|||||TWO_SIDED|90.0|106.82|176.81|||ANOVA|||Test: the moderate renal impairment group; Reference: the normal renal function group||176.81|106.82|
72565102|NCT03660241|144661834|OTHER|The ratio and 90% confidence interval were expressed as percentages.|Ratio of adjusted geometric means|177.92|||||TWO_SIDED|90.0|135.91|232.92|||ANOVA|||Test: the severe renal impairment group; Reference: the normal renal function group||232.92|135.91|
72565103|NCT03660241|144661835|OTHER|The ratio and 90% confidence interval were expressed as percentages.|Ratio of adjusted geometric means|269.78|||||TWO_SIDED|90.0|196.61|370.18|||ANOVA|||Test: the moderate renal impairment group; Reference: the normal renal function group||370.18|196.61|
72565104|NCT03660241|144661835|OTHER|The ratio and 90% confidence interval were expressed as percentages.|Ratio of adjusted geometric means|571.43|||||TWO_SIDED|90.0|447.27|730.05|||ANOVA|||Test: the severe renal impairment group; Reference: the normal renal function group||730.05|447.27|
72565105|NCT03660241|144661840|OTHER|The ratio and 90% confidence interval were expressed as percentages.|Ratio of adjusted geometric means|133.87|||||TWO_SIDED|90.0|102.45|174.92|||ANOVA|||Test: the moderate renal impairment group; Reference: the normal renal function group||174.92|102.45|
72468766|NCT03616964|144460936|SUPERIORITY||LS Mean difference (Final Values)|-0.52|STANDARD_ERROR_OF_MEAN|0.284||0.069|TWO_SIDED|95.0|-1.08|0.04|||Mixed Models Analysis|||||0.04|-1.08|0.069
72565106|NCT03660241|144661840|OTHER|The ratio and 90% confidence interval were expressed as percentages.|Ratio of adjusted geometric means|129.49|||||TWO_SIDED|90.0|92.86|180.57|||ANOVA|||Test: the severe renal impairment group; Reference: the normal renal function group||180.57|92.86|
72468767|NCT01385748|144460952|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.677||||0.165|TWO_SIDED|95.0|0.387|1.186|||Log Rank|The log rank test at 5% significance level was used.||||1.186|0.387|0.165
72468768|NCT01385748|144460952|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.817||||0.421|TWO_SIDED|95.0|0.495|1.35|||Log Rank|The log rank test at 5% significance level was used.||||1.35|0.495|0.421
72468769|NCT01385748|144460952|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.754||||0.211|TWO_SIDED|95.0|0.484|1.175|||Log Rank|The log rank test at 5% significance level was used.||||1.175|0.484|0.211
72468770|NCT01385748|144460955|SUPERIORITY_OR_OTHER|||||||0.807||||||Significance threshold = 5%|Wilcoxon (Mann-Whitney)|||||||0.807
72468771|NCT01385748|144460955|SUPERIORITY_OR_OTHER|||||||0.971||||||Significance threshold = 5%|Wilcoxon (Mann-Whitney)|||||||0.971
72468772|NCT01385748|144460957|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.698||||0.199|TWO_SIDED|95.0|0.398|1.223||Significance threshold = 5%|Log Rank|||||1.223|0.398|0.199
72468773|NCT01385748|144460957|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.817||||0.424|TWO_SIDED|95.0|0.493|1.353|||Log Rank|Significance threshold = 5%||||1.353|0.493|0.424
72468774|NCT01385748|144460957|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.764||||0.235|TWO_SIDED|95.0|0.489|1.193|||Log Rank|Significance threshold = 5%||||1.193|0.489|0.235
72468775|NCT01385748|144460958|SUPERIORITY_OR_OTHER|||||||0.176|||||||Kruskal-Wallis|Significance threshold = 5%||||||0.176
72468776|NCT01385748|144460958|SUPERIORITY_OR_OTHER|||||||0.61|||||||Kruskal-Wallis|Significance threshold = 5%||||||0.61
72468777|NCT01385748|144460958|SUPERIORITY_OR_OTHER|||||||0.295|||||||Kruskal-Wallis|Significance threshold = 5%||||||0.295
72468778|NCT01385748|144460959|SUPERIORITY_OR_OTHER|||||||0.063||||||Significance threshold = 5%|Chi-squared|||||||0.063
72468779|NCT01385748|144460959|SUPERIORITY_OR_OTHER|||||||0.169|||||||Chi-squared|||||||0.169
72468780|NCT01385748|144460959|SUPERIORITY_OR_OTHER|||||||0.064|||||||Chi-squared|Significance threshold = 5%||||||0.064
72622053|NCT04003142|144774321|SUPERIORITY||LSMean difference|-2.0|STANDARD_ERROR_OF_MEAN|0.7||0.007|TWO_SIDED|95.0|-3.5|-0.6||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||||-0.6|-3.5|0.007
72622054|NCT04003142|144774322|SUPERIORITY||LSMean difference|-1.3|STANDARD_ERROR_OF_MEAN|0.4||0.001|TWO_SIDED|95.0|-2.09|-0.51||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 1||-0.51|-2.09|0.001
72468781|NCT01385748|144460960|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.824||||0.388|TWO_SIDED|95.0|0.484|1.401|||Log Rank|Significance threshold = 5%||||1.401|0.484|0.388
72468782|NCT01385748|144460960|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.601||||0.054|TWO_SIDED|95.0|0.357|1.012|||Log Rank|Significance threshold = 5%||||1.012|0.357|0.054
72468783|NCT01385748|144460960|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.692||||0.102|TWO_SIDED|95.0|0.444|1.078|||Log Rank|Significance threshold = 5%||||1.078|0.444|0.102
72468784|NCT00656201|144460962|NON_INFERIORITY_OR_EQUIVALENCE|This was an equivalence comparison. The study was designed to detect a 14% pregnancy difference between the arms with 80% power and one interim analysis using O'Brien-Fleming parameters and an experiment-wise alpha level of 5%.|Odds Ratio (OR)|1.2|||<|0.05|TWO_SIDED|95.0|0.8|1.8|||Wilcoxon (Mann-Whitney)||Crinone is the numerator and IM Progesterone is the denominator.|||1.8|0.8|<0.05
72468785|NCT01458522|144460991|OTHER|||||||0.512|||||||Poisson regression model|||||||0.512
72468786|NCT04367480|144461027|SUPERIORITY||Mean Difference (Final Values)|1.05|STANDARD_ERROR_OF_MEAN|0.81||0.199|TWO_SIDED|95.0|-0.56|2.67|||ANCOVA|||"Missing data were accounted for using multiple imputation (MI) with the fully conditional specification (FCS) method. 100 replicates were imputed.~ANCOVA analysis was applied within each replicate. SAS PROC MI and MIANALYZE were used to calculate the reported estimates. (N: Active TENS=71, Placebo TENS=70)"||2.67|-0.56|0.199
72468787|NCT04367480|144461028|SUPERIORITY||Mean Difference (Final Values)|0.37|STANDARD_ERROR_OF_MEAN|0.36||0.302|TWO_SIDED|95.0|-0.34|1.08|||ANCOVA|||Analysis on the Study Completers (N: Active TENS=67, Placebo TENS=62)||1.08|-0.34|0.302
72468788|NCT04367480|144461028|SUPERIORITY||Mean Difference (Final Values)|1.37|STANDARD_ERROR_OF_MEAN|0.85||0.112|TWO_SIDED|95.0|-0.33|3.08|||ANCOVA|||Subgroup analysis on participants who reported at least 4 out of 10 at baseline for Hot/Burning Pain. (N: Active TENS=22, Placebo TENS=22)||3.08|-0.33|0.112
72468789|NCT04367480|144461029|SUPERIORITY||Mean Difference (Final Values)|0.33|STANDARD_ERROR_OF_MEAN|0.35||0.351|TWO_SIDED|95.0|-0.37|1.02|||ANCOVA|||Analysis on the Study Completers (N: Active TENS=67, Placebo TENS=62)||1.02|-0.37|0.351
72565107|NCT03660241|144661841|OTHER|The ratio and 90% confidence interval were expressed as percentages.|Ratio of adjusted geometric means|210.2|||||TWO_SIDED|90.0|154.6|285.8|||ANOVA|||Test: the moderate renal impairment group; Reference: the normal renal function group||285.80|154.60|
72565108|NCT03660241|144661841|OTHER|The ratio and 90% confidence interval were expressed as percentages.|Ratio of adjusted geometric means|290.68|||||TWO_SIDED|90.0|217.39|388.69|||ANOVA|||Test: the severe renal impairment group; Reference: the normal renal function group||388.69|217.39|
72565109|NCT00441350|144661842|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
72565110|NCT00441350|144661843|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||< 0.0001
72565111|NCT00441350|144661844|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||< 0.0001
72565112|NCT00441350|144661845|SUPERIORITY|||||||0.0001|||||||ANCOVA|||||||0.0001
72565113|NCT00255151|144661853|SUPERIORITY_OR_OTHER||||||<|1e-05||||||Hochberg's method was used to ensure that the overall 0.0025 level of significance was maintained for the pairwise comparisons between each dexlansoprazole MR dose and placebo.|Fisher Exact|||||||<0.00001
72565114|NCT00255151|144661853|SUPERIORITY_OR_OTHER||||||<|1e-05||||||Hochberg's method was used to ensure that the overall 0.0025 level of significance was maintained for the pairwise comparisons between each dexlansoprazole MR dose and placebo.|Fisher Exact|||||||<0.00001
72468790|NCT04367480|144461029|SUPERIORITY||Mean Difference (Final Values)|1.21|STANDARD_ERROR_OF_MEAN|0.78||0.128|TWO_SIDED|95.0|-0.36|2.79|||ANCOVA|||Subgroup analysis was performed on participants who reported at least 4 out of 10 at baseline for Sharp/Shooting Pain. (N: Active TENS=24, Placebo TENS=23)||2.79|-0.36|0.128
72468791|NCT04367480|144461030|SUPERIORITY||Mean Difference (Final Values)|0.53|STANDARD_ERROR_OF_MEAN|0.38||0.166|TWO_SIDED|95.0|-0.22|1.27|||ANCOVA|||Analysis on the Study Completers (N: Active TENS=67, Placebo TENS=62)||1.27|-0.22|0.166
72468792|NCT04367480|144461030|SUPERIORITY||Mean Difference (Final Values)|0.27|STANDARD_ERROR_OF_MEAN|0.39||0.492|TWO_SIDED|95.0|-0.51|1.05|||ANCOVA|||Subgroup analysis was performed on participants who reported at least 4 out of 10 at baseline for Numbness. (N: Active TENS=60, Placebo TENS=50)||1.05|-0.51|0.492
72468793|NCT04367480|144461031|SUPERIORITY||Mean Difference (Final Values)|0.19|STANDARD_ERROR_OF_MEAN|0.38||0.622|TWO_SIDED|95.0|-0.56|0.94|||ANCOVA|||Analysis on the Study Completers (N: Active TENS=67, Placebo TENS=62)||0.94|-0.56|0.622
72468794|NCT04367480|144461031|SUPERIORITY||Mean Difference (Final Values)|0.23|STANDARD_ERROR_OF_MEAN|0.43||0.587|TWO_SIDED|95.0|-0.61|1.08|||ANCOVA|||Subgroup analysis was performed on participants who reported at least 4 out of 10 at baseline for Tingling. (N: Active TENS=55, Placebo TENS=50)||1.08|-0.61|0.587
72468795|NCT04367480|144461032|SUPERIORITY||Mean Difference (Final Values)|0.64|STANDARD_ERROR_OF_MEAN|0.34||0.058|TWO_SIDED|95.0|-0.02|1.31|||ANCOVA|||Analysis on the Study Completers (N: Active TENS=67, Placebo TENS=62)||1.31|-0.02|0.058
72468796|NCT04367480|144461032|SUPERIORITY||Mean Difference (Final Values)|1.35|STANDARD_ERROR_OF_MEAN|0.82||0.11|TWO_SIDED|95.0|-0.32|3.02|||ANCOVA|||Subgroup analysis was performed on participants who reported at least 4 out of 10 at baseline for Cramping. (N: Active TENS=18, Placebo TENS=18)||3.02|-0.32|0.110
72468797|NCT00634842|144461033|NON_INFERIORITY_OR_EQUIVALENCE|The primary hypothesis was that there would be no difference in efficacy as measured by the proportion of subjects reaching HbA1c level \< 7% between the two FPG titration arms (70-90 mg/dL and 80-110 mg/dL, respectively) with a non-inferiority margin of 20%. If non-inferiority of the 70-90mg/dL arm was established, superiority was to be tested using a Logistic regression model with baseline HbA1c as a covariate. Superiority was to be concluded if the odds ratio was significantly greater than 1.|Odds Ratio (OR)|1.86||||0.0411||95.0|1.03|3.37|||Test for Difference in Proportions|||To show non-inferiority for the primary endpoint, 100 subjects per group provides 80% power to show that the 95% CI for the difference of proportions between treatments is within the 20% margin under the assumption of equality of proportions. It is also sufficient to show superiority under the assumption that the first proportion is greater than the second by at least 20%. With a predicted withdrawal rate of 15%, 236 subjects were needed based on a treatment ratio of 1:1 for the two treatments.||3.37|1.03|0.0411
72565115|NCT00255151|144661853|SUPERIORITY_OR_OTHER|||||||0.80473||95.0||||Statistical significance was determined at 0.0025 level without adjustment for multiple comparisons.|Fisher Exact|||||||0.80473
72622055|NCT04003142|144774322|SUPERIORITY||LSMean difference|-1.71|STANDARD_ERROR_OF_MEAN|0.4|<|0.001||95.0|-2.51|-0.91||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 1||-0.91|-2.51|<0.001
72468798|NCT00634842|144461034|NON_INFERIORITY_OR_EQUIVALENCE|The hypothesis was that there would be no difference in efficacy as measured by the proportion of subjects reaching HbA1c level \<= 6.5% between the two FPG titration arms (70-90 mg/dL and 80-110 mg/dL, respectively) with a non-inferiority margin of 20%. If non-inferiority of the 70-90mg/dL arm was established, superiority was to be tested using a Logistic regression model with baseline HbA1c as a covariate. Superiority was to be concluded if the odds ratio was significantly greater than 1.|Odds Ratio (OR)|2.34||||0.0064||95.0|1.27|4.3|||Regression, Logistic|||||4.30|1.27|0.0064
72468799|NCT00634842|144461035|SUPERIORITY_OR_OTHER||LSMean|-0.271||||0.0019||95.0|-0.441|-0.101|||ANCOVA|The analyses for HbA1c were adjusted for baseline HbA1c values.||||-0.101|-0.441|0.0019
72468800|NCT01642147|144461037|SUPERIORITY_OR_OTHER|||||||0.554||95.0||||Bonferroni correction is used when P-value is significant|Wilcoxon (Mann-Whitney)|||"H0: Mean Blood Flow Velocity in Middle Cerebral Artery of the 2 groups are the same before anesthesia.~Power calculation: beta=0.2, alpha=0.05, two-tailed"||||0.554
72468801|NCT01642147|144461038|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Bonferroni correction is used when P-value is significant|Wilcoxon (Mann-Whitney)|||"H0: Mean Blood Flow Velocity in Middle Cerebral Artery of the 2 groups are the same at extubation.~Power calculation: beta=0.2, alpha=0.05, two-tailed"||||<0.001
72468802|NCT01642147|144461039|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Bonferroni correction is used when P-value is significant|Wilcoxon (Mann-Whitney)|||"H0: mean blood flow velocity in middle cerebral artery of the 2 groups are the same 30min after extubation.~Power calculation: beta=0.2, alpha=0.05, two-tailed"||||<0.001
72565116|NCT00255151|144661854|SUPERIORITY_OR_OTHER||||||<|1e-05||95.0||||The 0.0025 level of significance for this secondary endpoint was controlled using Hochberg's method for comparisons of each dexlansoprazole MR dose to placebo.|Wilcoxon (Mann-Whitney)|||||||<0.00001
72565117|NCT00255151|144661854|SUPERIORITY_OR_OTHER||||||<|1e-05||95.0||||The 0.0025 level of significance for this secondary endpoint was controlled using Hochberg's method for comparisons of each dexlansoprazole MR dose to placebo.|Wilcoxon (Mann-Whitney)|||||||<0.00001
72565118|NCT00255151|144661854|SUPERIORITY_OR_OTHER|||||||0.76046||95.0||||Statistical significance was determined at 0.0025 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.76046
72565119|NCT00255151|144661856|SUPERIORITY_OR_OTHER||||||<|1e-05||95.0||||Hochberg's method was used to ensure that the overall 0.0025 level of significance was maintained for the pairwise comparisons between each dexlansoprazole MR dose and placebo.|Log Rank|||||||<0.00001
72565120|NCT00255151|144661856|SUPERIORITY_OR_OTHER||||||<|1e-05||95.0||||Hochberg's method was used to ensure that the overall 0.0025 level of significance was maintained for the pairwise comparisons between each dexlansoprazole MR dose and placebo.|Log Rank|||||||<0.00001
72468803|NCT01642147|144461040|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Bonferroni correction is used when P-value is significant|Wilcoxon (Mann-Whitney)|||"H0: mean blood flow velocity in middle cerebral artery of the 2 groups are the same 60min after extubation.~Power calculation: beta=0.2, alpha=0.05, two-tailed"||||<0.001
72468804|NCT01642147|144461041|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Bonferroni correction is used when P-value is significant|Wilcoxon (Mann-Whitney)|||"H0: mean blood flow velocity in middle cerebral artery of the 2 groups are the same 90min after extubation.~Power calculation: beta=0.2, alpha=0.05, two-tailed"||||<0.001
72468805|NCT01642147|144461042|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Bonferroni correction is used when P-value is significant|Wilcoxon (Mann-Whitney)|||"H0: mean blood flow velocity in middle cerebral artery of the 2 groups are the same 120min after extubation.~Power calculation: beta=0.2, alpha=0.05, two-tailed"||||<0.001
72468806|NCT02818998|144461102|NON_INFERIORITY|Non-inferiority margin: 4 letters|Least Squares mean difference|0.01|||<|0.0001|TWO_SIDED|95.0|-1.46|1.47||Non-inferiority was demonstrated if the p-value (adjusted for multiplicity using the Hochberg procedure) was \< 0.025|ANCOVA|||Aflibercept 2 mg fixed was regarded as the reference arm||1.47|-1.46|<0.0001
72468807|NCT02818998|144461102|NON_INFERIORITY|Non-inferiority margin: 4 letters|Least Squares mean difference|0.95|||<|0.0001|TWO_SIDED|95.0|-0.52|2.42||Non-inferiority was demonstrated if the p-value (adjusted for multiplicity using the Hochberg procedure) was \< 0.025|ANCOVA|||Aflibercept 2 mg fixed was regarded as the reference arm||2.42|-0.52|<0.0001
72468808|NCT02818998|144461103|OTHER||Least Square mean difference|14.38||||0.0105|TWO_SIDED|95.0|3.39|25.37|||ANCOVA|||Aflibercept 2 mg fixed was regarded as the reference arm||25.37|3.39|0.0105
72468809|NCT02818998|144461103|OTHER||Least Square mean difference|21.22||||0.0023|TWO_SIDED|95.0|7.65|34.8|||ANCOVA|||Aflibercept 2 mg fixed was regarded as the reference arm||34.80|7.65|0.0023
72468810|NCT02818998|144461104|OTHER||Treatment Difference|0.68|||||TWO_SIDED|95.0|-3.14|4.49|||Cochran-Mantel-Haenszel|||≥ 15 letter gain: Aflibercept 2 mg fixed was regarded as the reference arm||4.49|-3.14|
72468811|NCT02818998|144461104|OTHER||Treatment Difference|2.66|||||TWO_SIDED|95.0|-3.4|8.73|||Cochran-Mantel-Haenszel|||≥10 letter gain: Aflibercept 2 mg fixed was regarded as the reference arm||8.73|-3.40|
72468812|NCT02818998|144461104|OTHER||Treatment Difference|-0.66|||||TWO_SIDED|95.0|-1.94|0.63|||Cochran-Mantel-Haenszel|||≥30 letter loss: Aflibercept 2 mg fixed was regarded as the reference arm||0.63|-1.94|
72468813|NCT02818998|144461104|OTHER||Treatment Difference|-0.13|||||TWO_SIDED|95.0|-3.68|3.41|||Cochran-Mantel-Haenszel|||≥15 letter gain: Aflibercept 2 mg fixed was regarded as the reference arm||3.41|-3.68|
72468814|NCT02818998|144461104|OTHER||Treatment Difference|1.72|||||TWO_SIDED|95.0|-4.1|7.54|||Cochran-Mantel-Haenszel|||≥10 letter gain: Aflibercept 2 mg fixed was regarded as the reference arm||7.54|-4.10|
72468815|NCT02818998|144461104|OTHER||Treatment Difference|-0.68|||||TWO_SIDED|95.0|-2.0|0.65|||Cochran-Mantel-Haenszel|||≥30 letter loss: Aflibercept 2 mg fixed was regarded as the reference arm||0.65|-2.00|
72468816|NCT02818998|144461105|NON_INFERIORITY|Non-inferiority margin: 4 letters|Least Squares mean difference|-0.3|||<|0.0001|TWO_SIDED|95.0|-2.13|1.52|||ANCOVA|||Aflibercept 2 mg fixed was regarded as the reference arm||1.52|-2.13|<0.0001
72468817|NCT02818998|144461105|NON_INFERIORITY|Non-inferiority margin: 4 letters|Least Squares mean difference|1.39|||<|0.0001|TWO_SIDED|95.0|-0.4|3.19|||ANCOVA|||Aflibercept 2 mg fixed was regarded as the reference arm||3.19|-0.40|<0.0001
72468818|NCT02818998|144461106|OTHER||Least Square mean difference|16.14||||0.0416|TWO_SIDED|95.0|0.62|31.66|||ANCOVA|||Aflibercept 2 mg fixed was regarded as the reference arm||31.66|0.62|0.0416
72468819|NCT02818998|144461106|OTHER||Least Square mean difference|4.12||||0.5524|TWO_SIDED|95.0|-9.52|17.77|||ANCOVA|||Aflibercept 2 mg fixed was regarded as the reference arm||17.77|-9.52|0.5524
72468820|NCT02818998|144461107|OTHER||Treatment Difference|0.67|||||TWO_SIDED|95.0|-2.72|4.05|||Cochran-Mantel-Haenszel|||≥ 15 letter gain: Aflibercept 2 mg fixed was regarded as the reference arm||4.05|-2.72|
72468821|NCT02818998|144461107|OTHER||Treatment Difference|4.63|||||TWO_SIDED|95.0|-1.73|10.98|||Cochran-Mantel-Haenszel|||≥10 letter gain: Aflibercept 2 mg fixed was regarded as the reference arm||10.98|-1.73|
72468822|NCT02818998|144461107|OTHER||Treatment Difference|0.66|||||TWO_SIDED|95.0|-1.56|2.87|||Cochran-Mantel-Haenszel|||≥30 letter loss: Aflibercept 2 mg fixed was regarded as the reference arm||2.87|-1.56|
72468823|NCT02818998|144461107|OTHER||Treatment Difference|1.9|||||TWO_SIDED|95.0|-1.89|5.69|||Cochran-Mantel-Haenszel|||≥15 letter gain: Aflibercept 2 mg fixed was regarded as the reference arm||5.69|-1.89|
72468824|NCT02818998|144461107|OTHER||Treatment Difference|7.54|||||TWO_SIDED|95.0|0.81|14.28|||Cochran-Mantel-Haenszel|||≥10 letter gain: Aflibercept 2 mg fixed was regarded as the reference arm||14.28|0.81|
72468825|NCT02818998|144461107|OTHER||Treatment Difference|0.63|||||TWO_SIDED|95.0|-1.61|2.88|||Cochran-Mantel-Haenszel|||≥30 letter loss: Aflibercept 2 mg fixed was regarded as the reference arm||2.88|-1.61|
72468826|NCT05043883|144461123|SUPERIORITY|This clinical investigation is intended to demonstrate that the performance of the PVI Analyzer software is superior to clinically relevant performance level, and therefore the study is designed as a 1-sample superiority test of the sampled outcome specificity. The lower bound 95% CI (α=0.05) and at a statistical power of 95% (β=0.05).|Percentage (%)|87.0||||0.006|ONE_SIDED|95.0||||The success of the PVI Analyzer output was assumed to follow a binominal distribution with a given true proportion of 87.50%. It was tested whether the specificity was superior to the 80% limit.|Z-test|A one-tailed test with a significance level of 95% (α = 0.05) was applied.||Specificity is the ability to correctly detect true negative values of the ground-truth negative EGM classifications. The PVI Analyzer software classifies an EGM in positive (isolated) or negative (non-isolated), compared to the SOC outcomes. EGMs prior-isolation were labeled as ground-truth negative (non-isolated), EGMs after isolation as ground-truth positive (isolated). The null hypothesis is that specificity is lower or equal to the superiority limit 80%.||||0.006
72565121|NCT00255151|144661856|SUPERIORITY_OR_OTHER|||||||0.37161||95.0||||Statistical significance was determined at 0.0025 level without adjustment for multiple comparisons.|Log Rank|||||||0.37161
72394760|NCT03765918|144296094|OTHER|Based on a cLDA model with the PRO scores as the response variable with covariates for treatment by study visit interaction, and stratification factors by primary tumor site, tumor stage, and PD-L1 status.|Difference in Least Square Means|0.53||||0.7761|TWO_SIDED|95.0|-3.12|4.18||Two-sided p-value based on cLDA model.|cLDA model|||||4.18|-3.12|0.7761
72394761|NCT03765918|144296095|OTHER|Based on a cLDA model with the PRO scores as the response variable with covariates for treatment by study visit interaction, and stratification factors by primary tumor site, tumor stage, and PD-L1 status.|Difference in Least Square Means|0.65||||0.688|TWO_SIDED|95.0|-2.54|3.84||Two-sided p-value based on cLDA model.|cLDA model|||||3.84|-2.54|0.6880
72394762|NCT03765918|144296096|OTHER|Based on a cLDA model with the PRO scores as the response variable with covariates for treatment by study visit interaction, and stratification factors by primary tumor site, tumor stage, and PD-L1 status.|Difference in Least Square Means|-1.45||||0.3858|TWO_SIDED|95.0|-4.73|1.83||Two-sided p-value based on cLDA model.|cLDA model|||||1.83|-4.73|0.3858
72394763|NCT03765918|144296097|OTHER|Based on a cLDA model with the PRO scores as the response variable with covariates for treatment by study visit interaction, and stratification factors by primary tumor site, tumor stage, and PD-L1 status.|Difference in Least Square Means|-2.45||||0.237|TWO_SIDED|95.0|-6.53|1.62||Two-sided p-value based on cLDA model.|cLDA model|||||1.62|-6.53|0.2370
72394764|NCT03765918|144296098|OTHER|Based on a cLDA model with the PRO scores as the response variable with covariates for treatment by study visit interaction, and stratification factors by primary tumor site, tumor stage, and PD-L1 status.|Difference in Least Square Means|-1.76||||0.3138|TWO_SIDED|95.0|-5.2|1.67||Two-sided p-value based on cLDA model.|cLDA model|||||1.67|-5.20|0.3138
72394765|NCT03765918|144296105|OTHER|Based on a cLDA model with the PRO scores as the response variable with covariates for treatment by study visit interaction, and stratification factors by primary tumor site, tumor stage, and PD-L1 status.|Difference in Least Square Means|-3.28||||0.1763|TWO_SIDED|95.0|-8.05|1.48||Two-sided p-value based on cLDA model.|cLDA model|||||1.48|-8.05|0.1763
72394766|NCT03765918|144296106|OTHER|Based on a cLDA model with the PRO scores as the response variable with covariates for treatment by study visit interaction, and stratification factors by primary tumor site, tumor stage, and PD-L1 status.|Difference in Least Square Means|-1.18||||0.6882|TWO_SIDED|95.0|-6.95|4.59||Two-sided p-value based on cLDA model.|cLDA model|||||4.59|-6.95|0.6882
72394767|NCT03765918|144296107|OTHER|Based on a cLDA model with the PRO scores as the response variable with covariates for treatment by study visit interaction, and stratification factors by primary tumor site, tumor stage, and PD-L1 status.|Difference in Least Square Means|-2.52||||0.3103|TWO_SIDED|95.0|-7.39|2.35||Two-sided p-value based on cLDA model.|cLDA model|||||2.35|-7.39|0.3103
72394768|NCT03765918|144296108|OTHER|Based on a cLDA model with the PRO scores as the response variable with covariates for treatment by study visit interaction, and stratification factors by primary tumor site, tumor stage, and PD-L1 status.|Difference in Least Square Means|-0.48||||0.8475|TWO_SIDED|95.0|-5.41|4.45||Two-sided p-value based on cLDA model.|cLDA model|||||4.45|-5.41|0.8475
72394769|NCT03765918|144296109|OTHER|Based on a cLDA model with the PRO scores as the response variable with covariates for treatment by study visit interaction, and stratification factors by primary tumor site, tumor stage, and PD-L1 status.|Difference in Least Square Means|-0.42||||0.8881|TWO_SIDED|95.0|-6.36|5.51||Two-sided p-value based on cLDA model.|cLDA model|||||5.51|-6.36|0.8881
72468827|NCT05043883|144461123|SUPERIORITY|This clinical investigation is intended to demonstrate that the performance of the PVI Analyzer software is superior to clinically relevant performance level, and therefore the study is designed as a 1-sample superiority test of the sampled outcome Sensitivity. The lower bound 95% CI (α=0.05) and at a statistical power of 95% (β=0.05).|Percentage|86.0||||0.004|ONE_SIDED|95.0||||The success of the PVI Analyzer output was assumed to follow a binominal distribution with a given true proportion of 87.50%. It was tested whether the sensitivity was superior to the 80% limit.|Z-test|A one-tailed test with a significance level of 95% (α = 0.05) was applied.||Sensitivity of the PVI analyzer is determined by the capability to detect true positive among all ground-truth positive EGM classifications.The PVI Analyzer software classifies an EGM in positive (isolated) or negative (non-isolated), compared to the SOC outcomes. EGMs prior-isolation were labeled as ground-truth negative (non-isolated), EGMs after isolation as ground-truth positive (isolated). The null hypothesis is that sensitivity is lower or equal to the superiority limit 80%.||||0.004
72394770|NCT03765918|144296110|OTHER|Based on a cLDA model with the PRO scores as the response variable with covariates for treatment by study visit interaction, and stratification factors by primary tumor site, tumor stage, and PD-L1 status.|Difference in Least Square Means|-0.22||||0.9307|TWO_SIDED|95.0|-5.22|4.78||Two-sided p-value based on cLDA model.|cLDA model|||||4.78|-5.22|0.9307
72394771|NCT03765918|144296117|OTHER|Based on a cLDA model with the PRO scores as the response variable with covariates for treatment by study visit interaction, and stratification factors by primary tumor site, tumor stage, and PD-L1 status.|Difference in Least Square Means|1.3||||0.5752|TWO_SIDED|95.0|-3.25|5.85||Two-sided p-value based on cLDA model.|cLDA model|||||5.85|-3.25|0.5752
72468828|NCT05043883|144461124|OTHER|Descriptive|Percentage|0.99|STANDARD_DEVIATION|0.1|||TWO_SIDED|95.0|0.02|5.39|||||Only one AE was reported for one subject ( which was considered moderate in severity and not related to the device, but related to the SOC procedure.|A descriptive analysis was performed to evaluate the AEs and device deficiencies, estimating the percentages and 95% CI on each category.||5.39|0.02|
72468829|NCT05043883|144461125|SUPERIORITY||Percentage (%)|94.0||||2e-05|TWO_SIDED|||||Computed p values are the result of running a one sample z-test with a null hypothesis that specificity is below 80%.|Z-test|||Automated PVI Analyzer classification of PV isolation in SR by Radiofrequency procedure from EP procedure until study completion at discharge (an average of 24 hours), with a specificity superior to 80%. A superiority Z-test for Specificity was performed.||||0.00002
72468830|NCT05043883|144461125|SUPERIORITY||Percentage (%)|82.0||||0.32|TWO_SIDED|||||Computed p values are the result of running a one sample z-test with a null hypothesis that sensitivity is below 80% and alternative hypothesis that sensitivity is at or above 80%.|Z-test|||Automated PVI Analyzer classification of PV isolation in SR by Radiofrequency procedure from EP procedure until study completion at discharge (an average of 24 hours), with sensitivity superior to 80%. A superiority Z-test for Sensitivity was performed.||||0.32
72504210|NCT01025336|144539194|SUPERIORITY_OR_OTHER||Ratio of GMT|0.7|||||TWO_SIDED|95.0|0.48|1.17|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/13vPnC - 13vPnC/23vPS)\]|Serotype 18C: Ratio of GMT (13vPnC/13vPnC to 13vPnC/23vPS) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale.||1.17|0.48|
72504211|NCT01025336|144539194|SUPERIORITY_OR_OTHER||Ratio of GMT|0.8|||||TWO_SIDED|95.0|0.58|1.05|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/13vPnC - 13vPnC/23vPS)\]|Serotype 19A: Ratio of GMT (13vPnC/13vPnC to 13vPnC/23vPS) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale.||1.05|0.58|
72504212|NCT01025336|144539194|SUPERIORITY_OR_OTHER||Ratio of GMT|0.6|||||TWO_SIDED|95.0|0.41|0.88|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/13vPnC - 13vPnC/23vPS)\]|Serotype 19F: Ratio of GMT (13vPnC/13vPnC to 13vPnC/23vPS) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale.||0.88|0.41|
72504213|NCT01025336|144539194|SUPERIORITY_OR_OTHER||Ratio of GMT|1.7|||||TWO_SIDED|95.0|1.05|2.81|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/13vPnC - 13vPnC/23vPS)\]|Serotype 23F: Ratio of GMT (13vPnC/13vPnC to 13vPnC/23vPS) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale.||2.81|1.05|
72504214|NCT01025336|144539195|SUPERIORITY_OR_OTHER||Ratio of GMT|1.7|||||TWO_SIDED|95.0|1.27|2.4|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/13vPnC - 23vPS/13vPnC)\]|Serotype 1: Ratio of GMT (13vPnC/13vPnC to 23vPS/13vPnC) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale||2.40|1.27|
72504215|NCT01025336|144539195|SUPERIORITY_OR_OTHER||Ratio of GMT|1.2|||||TWO_SIDED|95.0|0.95|1.59|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/13vPnC - 23vPS/13vPnC)\]|Serotype 3: Ratio of GMT (13vPnC/13vPnC to 23vPS/13vPnC) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale||1.59|0.95|
72504216|NCT01025336|144539195|SUPERIORITY_OR_OTHER||Ratio of GMT|1.5|||||TWO_SIDED|95.0|1.03|2.29|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/13vPnC - 23vPS/13vPnC)\]|Serotype 4: Ratio of GMT (13vPnC/13vPnC to 23vPS/13vPnC) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale||2.29|1.03|
72504217|NCT01025336|144539195|SUPERIORITY_OR_OTHER||Ratio of GMT|1.4|||||TWO_SIDED|95.0|0.95|1.97|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/13vPnC - 23vPS/13vPnC)\]|Serotype 5: Ratio of GMT (13vPnC/13vPnC to 23vPS/13vPnC) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale||1.97|0.95|
72504218|NCT01025336|144539195|SUPERIORITY_OR_OTHER||Ratio of GMT|2.2|||||TWO_SIDED|95.0|1.42|3.31|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/13vPnC - 23vPS/13vPnC)\]|Serotype 6A: Ratio of GMT (13vPnC/13vPnC to 23vPS/13vPnC) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale||3.31|1.42|
72565122|NCT00255151|144661857|SUPERIORITY_OR_OTHER||||||<|1e-05||95.0||||The 0.0025 level of significance for this secondary endpoint was controlled using Hochberg's method for comparisons of each dexlansoprazole MR dose to placebo.|Wilcoxon (Mann-Whitney)|||||||<0.00001
72565123|NCT00255151|144661857|SUPERIORITY_OR_OTHER||||||<|1e-05||95.0||||The 0.0025 level of significance for this secondary endpoint was controlled using Hochberg's method for comparisons of each dexlansoprazole MR dose to placebo.|Wilcoxon (Mann-Whitney)|||||||<0.00001
72504219|NCT01025336|144539195|SUPERIORITY_OR_OTHER||Ratio of GMT|1.3|||||TWO_SIDED|95.0|0.88|2.04|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/13vPnC - 23vPS/13vPnC)\]|Serotype 6B: Ratio of GMT (13vPnC/13vPnC to 23vPS/13vPnC) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale||2.04|0.88|
72504220|NCT01025336|144539195|SUPERIORITY_OR_OTHER||Ratio of GMT|1.5|||||TWO_SIDED|95.0|0.95|2.4|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/13vPnC - 23vPS/13vPnC)\]|Serotype 7F: Ratio of GMT (13vPnC/13vPnC to 23vPS/13vPnC) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale||2.40|0.95|
72504221|NCT01025336|144539195|SUPERIORITY_OR_OTHER||Ratio of GMT|1.2|||||TWO_SIDED|95.0|0.7|1.99|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/13vPnC - 23vPS/13vPnC)\]|Serotype 9V: Ratio of GMT (13vPnC/13vPnC to 23vPS/13vPnC) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale||1.99|0.70|
72504222|NCT01025336|144539195|SUPERIORITY_OR_OTHER||Ratio of GMT|0.8|||||TWO_SIDED|95.0|0.57|1.25|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/13vPnC - 23vPS/13vPnC)\]|Serotype 14: Ratio of GMT (13vPnC/13vPnC to 23vPS/13vPnC) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale||1.25|0.57|
72565124|NCT00255151|144661857|SUPERIORITY_OR_OTHER|||||||0.597||95.0||||Statistical significance was determined at the 0.0025 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.59700
72565125|NCT00934596|144661863|SUPERIORITY_OR_OTHER||Median Difference (Net)|57.0|||<|0.01||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.01
72565126|NCT00934596|144661866|SUPERIORITY_OR_OTHER||Median Difference (Net)|72.0|||<|0.001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.001
72565127|NCT00934596|144661871|SUPERIORITY_OR_OTHER||Median Difference (Net)|17.0|||<|0.001||95.0|||||Wilcoxon (Mann-Whitney)|||As data for these small groups were non-parametric the median and quartiles were used for comparison of groups by the Wilcoxon Rank Sum test.||||<0.001
72394772|NCT03765918|144296118|OTHER|Based on a cLDA model with the PRO scores as the response variable with covariates for treatment by study visit interaction, and stratification factors by primary tumor site, tumor stage, and PD-L1 status.|Difference in Least Square Means|0.98||||0.7196|TWO_SIDED|95.0|-4.38|6.34||Two-sided p-value based on cLDA model.|cLDA model|||||6.34|-4.38|0.7196
72394773|NCT03765918|144296119|OTHER|Based on a cLDA model with the PRO scores as the response variable with covariates for treatment by study visit interaction, and stratification factors by primary tumor site, tumor stage, and PD-L1 status.|Difference in Least Square Means|0.74||||0.7522|TWO_SIDED|95.0|-3.88|5.37||Two-sided p-value based on cLDA model.|cLDA model|||||5.37|-3.88|0.7522
72468831|NCT05043883|144461125|SUPERIORITY||Percentage (%)|79.0||||0.66|TWO_SIDED|||||Computed p values are the result of running a one sample z-test with a null hypothesis that specificity is below 80%.|Z-test|||Automated PVI Analyzer classification of PV isolation in SR by Cryo-balloon procedure from EP procedure until study completion at discharge (an average of 24 hours), with a specificity superior to 80%. A superiority Z-test for Specificity was performed.||||0.66
72468832|NCT05043883|144461125|SUPERIORITY||Percentage (%)|92.0||||0.0008|TWO_SIDED|||||Computed p values are the result of running a one sample z-test with a null hypothesis that sensitivity is below 80% and alternative hypothesis that sensitivity is at or above 80%.|Z-test|||Automated PVI Analyzer classification of PV isolation in SR by Cryo-balloon procedure from EP procedure until study completion at discharge (an average of 24 hours), with a sensitivity superior to 80%. A superiority Z-test for Sensitivity was performed.||||0.0008
72468833|NCT05043883|144461126|SUPERIORITY||Percentage (%)|96.0||||5e-06|TWO_SIDED|||||To compute the proportional agreement between two non-overlapping samples, a one-sample Z-test was performed with the alternative hypothesis that agreement was above 90%, which was considered sufficient for a real-time assessment.|Z-test|||This endpoint used the same EGMs extracted for the primary endpoint, including only EGMs from T Baseline and T Final measurements from patients in sinus rhythm.||||0.000005
72468834|NCT05043883|144461127|SUPERIORITY||Percentage (%)|54.0||||1|TWO_SIDED|||||The p values calculated are the result of running a one sample z-test with a null hypothesis that the specificity are below 80%.|Z-test|||The data analysis and processing were similar to those of the primary endpoint, but taking into consideration that subjects shall be in non-sinus rhythm during the duration of the EGM snippet. Apart from this, the processing was the same and the threshold was also defined as 50: values below 50 were classified as baseline, while values at or above 50 were considered as isolated veins.||||1
72468835|NCT05043883|144461127|SUPERIORITY||Percentage (%)|100.0||||0.0007|TWO_SIDED|||||The p values calculated are the result of running a one sample z-test with a null hypothesis that the sensitivity are below 80% and an alternative hypothesis that sensitivity is at or above 80%.|Z-test|||The data analysis and processing were similar to those of the primary endpoint, but taking into consideration that subjects shall be in non-sinus rhythm during the duration of the EGM snippet. Apart from this, the processing was the same and the threshold was also defined as 50: values below 50 were classified as baseline, while values at or above 50 were considered as isolated veins.||||0.0007
72468836|NCT05043883|144461128|SUPERIORITY||Percentage (%)|87.0||||0.04|TWO_SIDED||||||Z-test|The estimate was done using a one-sample Z-test with a null hypothesis that sensitivity is at or below 80% and a 95% significance level.||This secondary endpoint aimed to determine the sensitivity of the PVI Analyzer at the time of isolation, which requires the EGMs at the T PVI. A Z-test for sensitivity was performed to assess the sensitivity of the PVI Analyzer analysis to identify expert-defined isolation during the PVI ablation.||||0.04
72504223|NCT01025336|144539195|SUPERIORITY_OR_OTHER||Ratio of GMT|1.5|||||TWO_SIDED|95.0|1.06|2.12|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/13vPnC - 23vPS/13vPnC)\]|Serotype 18C: Ratio of GMT (13vPnC/13vPnC to 23vPS/13vPnC) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale||2.12|1.06|
72394774|NCT03765918|144296120|OTHER|Based on a cLDA model with the PRO scores as the response variable with covariates for treatment by study visit interaction, and stratification factors by primary tumor site, tumor stage, and PD-L1 status.|Difference in Least Square Means|-0.24||||0.9255|TWO_SIDED|95.0|-5.3|4.82||Two-sided p-value based on cLDA model.|cLDA model|||||4.82|-5.30|0.9255
72394775|NCT03765918|144296121|OTHER|Based on a cLDA model with the PRO scores as the response variable with covariates for treatment by study visit interaction, and stratification factors by primary tumor site, tumor stage, and PD-L1 status.|Difference in Least Square Means|2.22||||0.4926|TWO_SIDED|95.0|-4.15|8.6||Two-sided p-value based on cLDA model.|cLDA model|||||8.60|-4.15|0.4926
72394776|NCT03765918|144296122|OTHER|Based on a cLDA model with the PRO scores as the response variable with covariates for treatment by study visit interaction, and stratification factors by primary tumor site, tumor stage, and PD-L1 status.|Difference in Least Square Means|0.99||||0.7087|TWO_SIDED|95.0|-4.23|6.21||Two-sided p-value based on cLDA model.|cLDA model|||||6.21|-4.23|0.7087
72468837|NCT05043883|144461129|OTHER|||||||0.0002||||||McNemar test assumes as a null hypothesis that the two datasets cause the PVI Analyzer to have a similar proportion of errors.|McNemars test|A paired McNemars test with an alpha value of 0.05, was applied to analyze the differences in classification performance.||A paired McNemar's Chi-Square test was performed to analyze the differences in classification performances||||0.0002
72468838|NCT01586975|144461136|SUPERIORITY_OR_OTHER|||||||0.0742|TWO_SIDED|||||p-value is not adjusted, and no a priori threshold was used|Kruskal-Wallis|||Kruskal-Wallis non-parametric ANOVA test||||0.0742
72468839|NCT01407276|144461141|SUPERIORITY_OR_OTHER||GMR|0.94|||||TWO_SIDED|90.0|0.8|1.11|||Geometric mean ratio (GMR)|GMR of Panel A:Panel B||||1.11|0.80|
72468840|NCT01407276|144461141|SUPERIORITY_OR_OTHER||GMR of Panel C:Panel D|1.34|||||TWO_SIDED|90.0|1.12|1.61|||GMR of Panel C:Panel D|||||1.61|1.12|
72468841|NCT01407276|144461141|SUPERIORITY_OR_OTHER||GMR of Panel E:Panel F|1.56|||||TWO_SIDED|90.0|1.32|1.85|||GMR of Panel E:Panel F|||||1.85|1.32|
72504224|NCT01025336|144539195|SUPERIORITY_OR_OTHER||Ratio of GMT|1.3|||||TWO_SIDED|95.0|0.97|1.69|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/13vPnC - 23vPS/13vPnC)\]|Serotype 19A: Ratio of GMT (13vPnC/13vPnC to 23vPS/13vPnC) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale||1.69|0.97|
72504225|NCT01025336|144539195|SUPERIORITY_OR_OTHER||Ratio of GMT|1.8|||||TWO_SIDED|95.0|1.21|2.53|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/13vPnC - 23vPS/13vPnC)\]|Serotype 19F: Ratio of GMT (13vPnC/13vPnC to 23vPS/13vPnC) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale||2.53|1.21|
72504226|NCT01025336|144539195|SUPERIORITY_OR_OTHER||Ratio of GMT|2.3|||||TWO_SIDED|95.0|1.54|3.42|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/13vPnC - 23vPS/13vPnC)\]|Serotype 23F: Ratio of GMT (13vPnC/13vPnC to 23vPS/13vPnC) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale||3.42|1.54|
72504227|NCT01025336|144539196|SUPERIORITY_OR_OTHER||Ratio of GMT|1.1|||||TWO_SIDED|95.0|0.8|1.63|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/23vPS - 23vPS)\]|Serotype 1: Ratio of GMT (13vPnC/23vPS to 23vPS) was calculated by back transforming the mean difference between vaccine sequence/group on the logarithmic scale.||1.63|0.80|
72504228|NCT01025336|144539196|SUPERIORITY_OR_OTHER||Ratio of GMT|1.0|||||TWO_SIDED|95.0|0.77|1.39|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/23vPS - 23vPS)\]|Serotype 3: Ratio of GMT (13vPnC/23vPS to 23vPS) was calculated by back transforming the mean difference between vaccine sequence/group on the logarithmic scale.||1.39|0.77|
72504229|NCT01025336|144539196|SUPERIORITY_OR_OTHER||Ratio of GMT|1.1|||||TWO_SIDED|95.0|0.68|1.69|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/23vPS - 23vPS)\]|Serotype 4: Ratio of GMT (13vPnC/23vPS to 23vPS) was calculated by back transforming the mean difference between vaccine sequence/group on the logarithmic scale.||1.69|0.68|
72504230|NCT01025336|144539196|SUPERIORITY_OR_OTHER||Ratio of GMT|1.5|||||TWO_SIDED|95.0|1.03|2.31|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/23vPS - 23vPS)\]|Serotype 5: Ratio of GMT (13vPnC/23vPS to 23vPS) was calculated by back transforming the mean difference between vaccine sequence/group on the logarithmic scale.||2.31|1.03|
72504231|NCT01025336|144539196|SUPERIORITY_OR_OTHER||Ratio of GMT|2.7|||||TWO_SIDED|95.0|1.66|4.55|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/23vPS - 23vPS)\]|Serotype 6A: Ratio of GMT (13vPnC/23vPS to 23vPS) was calculated by back transforming the mean difference between vaccine sequence/group on the logarithmic scale.||4.55|1.66|
72565128|NCT01332578|144661875|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-20.92||||0.0004|TWO_SIDED|95.0|-27.31|-15.81|||Wilcoxon (Mann-Whitney)||Hodges-Lehmann estimate of median difference was determined.|Null hypothesis was no difference between test hot drink and standard paracetamol tablets.||-15.81|-27.31|0.0004
72565129|NCT00107042|144661883|SUPERIORITY_OR_OTHER|||||||0.2954|||||||Fisher Exact|||The study wasn't powered to compare the 2 arms but to detect a large difference. A quantitative antibody (a'body) response was measured, but for sample size and power considerations, the outcome was considered to be binary. The primary analysis involved straightforward computation of point estimates and exact confidence intervals of immunogenicity in each arm. The data for primary analysis used the Intent-to-Treat for subjects who were vaccinated at least once. Missing titers were not imputed.||||0.2954
72504232|NCT01025336|144539196|SUPERIORITY_OR_OTHER||Ratio of GMT|3.7|||||TWO_SIDED|95.0|2.25|5.94|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/23vPS - 23vPS)\]|Serotype 6B: Ratio of GMT (13vPnC/23vPS to 23vPS) was calculated by back transforming the mean difference between vaccine sequence/group on the logarithmic scale.||5.94|2.25|
72504233|NCT01025336|144539196|SUPERIORITY_OR_OTHER||Ratio of GMT|6.2|||||TWO_SIDED|95.0|3.85|9.98|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/23vPS - 23vPS)\]|Serotype 7F: Ratio of GMT (13vPnC/23vPS to 23vPS) was calculated by back transforming the mean difference between vaccine sequence/group on the logarithmic scale.||9.98|3.85|
72504234|NCT01025336|144539196|SUPERIORITY_OR_OTHER||Ratio of GMT|4.2|||||TWO_SIDED|95.0|2.43|7.4|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/23vPS - 23vPS)\]|Serotype 9V: Ratio of GMT (13vPnC/23vPS to 23vPS) was calculated by back transforming the mean difference between vaccine sequence/group on the logarithmic scale.||7.40|2.43|
72622056|NCT04003142|144774322|SUPERIORITY||LSMean difference|-1.76|STANDARD_ERROR_OF_MEAN|0.45|<|0.001||95.0|-2.65|-0.87||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 2||-0.87|-2.65|<0.001
72504235|NCT01025336|144539196|SUPERIORITY_OR_OTHER||Ratio of GMT|1.4|||||TWO_SIDED|95.0|0.89|2.13|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/23vPS - 23vPS)\]|Serotype 14: Ratio of GMT (13vPnC/23vPS to 23vPS) was calculated by back transforming the mean difference between vaccine sequence/group on the logarithmic scale.||2.13|0.89|
72565130|NCT00107042|144661883|SUPERIORITY_OR_OTHER||Response Rate|87.23|||||TWO_SIDED|95.0|74.26|95.17|||95% confidence interval|||"Two-sided confidence intervals (CI) were calculated for both the Recombivax and Twinrix arms. The CI for the Recombivax arm is presented here."||95.17|74.26|
72565131|NCT00107042|144661883|SUPERIORITY_OR_OTHER||Response Rate|94.55|||||TWO_SIDED|95.0|84.88|98.86|||95% confidence interval|||"Two-sided confidence intervals (CI) were calculated for both the Recombivax and Twinrix arms. The CI for the 'Twinrix arm is presented here."||98.86|84.88|
72468842|NCT01407276|144461141|SUPERIORITY_OR_OTHER||GMR or Panel G:Panel H|1.89|||||TWO_SIDED|90.0|1.4|2.55|||GMR of Panel G:Panel H|||||2.55|1.40|
72468843|NCT01407276|144461141|SUPERIORITY_OR_OTHER||GMR of Panel G:Panel H|1.97|||||TWO_SIDED|90.0|1.46|2.66|||GMR of Panel G:Panel H|||||2.66|1.46|
72468844|NCT01407276|144461142|SUPERIORITY_OR_OTHER||GMR of Panel A:Panel B|0.94|||||TWO_SIDED|90.0|0.79|1.12|||GMR of Panel A:Panel B|||||1.12|0.79|
72468845|NCT01407276|144461142|SUPERIORITY_OR_OTHER||GMR of Panel C:Panel D|1.13|||||TWO_SIDED|90.0|0.91|1.41|||GMR of Panel C:Panel D|||||1.41|0.91|
72468846|NCT01407276|144461142|SUPERIORITY_OR_OTHER||GMR of Panel E:Panel F|0.9|||||TWO_SIDED|90.0|0.66|1.23|||GMR of Panel E:Panel F|||||1.23|0.66|
72468847|NCT01407276|144461142|SUPERIORITY_OR_OTHER||GMR of Panel E:Panel F|0.74|||||TWO_SIDED|90.0|0.57|0.96|||GMR of Panel E:Panel F|||||0.96|0.57|
72468848|NCT01407276|144461142|SUPERIORITY_OR_OTHER||GMR of Panel E:Panel F|0.73|||||TWO_SIDED|90.0|0.56|0.95|||GMR of Panel E:Panel F|||||0.95|0.56|
72468849|NCT01407276|144461143|SUPERIORITY_OR_OTHER||GMR of Panel A:Panel B|0.92|||||TWO_SIDED|90.0|0.81|1.05|||GMR of Panel A:Panel B|||||1.05|0.81|
72468850|NCT01407276|144461143|SUPERIORITY_OR_OTHER||GMR of Panel C:Panel D|1.33||||||90.0|1.07|1.65|||GMR of Panel C:Panel D|||||1.65|1.07|
72622057|NCT04003142|144774322|SUPERIORITY||LSMean difference|-1.97|STANDARD_ERROR_OF_MEAN|0.45|<|0.001||95.0|-2.86|-1.08||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 2||-1.08|-2.86|<0.001
72468851|NCT01407276|144461143|SUPERIORITY_OR_OTHER||GMR of Panel E:Panel F|1.37|||||TWO_SIDED|90.0|1.13|1.65|||GMR of Panel E:Panel F|||||1.65|1.13|
72468852|NCT01407276|144461143|SUPERIORITY_OR_OTHER||GMR of Panel G:Panel H|1.38|||||TWO_SIDED|90.0|1.06|1.79|||GMR of Panel G:Panel H|||||1.79|1.06|
72468853|NCT01407276|144461143|SUPERIORITY_OR_OTHER||GMR of Panel G:Panel H|1.3|||||TWO_SIDED|90.0|1.0|1.68|||GMR of Panel G:Panel H|||||1.68|1.00|
72468854|NCT01407276|144461144|SUPERIORITY_OR_OTHER||GMR of Panel A:Panel B|0.92|||||TWO_SIDED|90.0|0.75|1.12|||GMR of Panel A:Panel B|||||1.12|0.75|
72468855|NCT01407276|144461144|SUPERIORITY_OR_OTHER||GMR of Panel C:Panel D|1.45|||||TWO_SIDED|90.0|1.19|1.76|||GMR of Panel C:Panel D|||||1.76|1.19|
72468856|NCT01407276|144461144|SUPERIORITY_OR_OTHER||GMR of Panel E:Panel F|1.83|||||TWO_SIDED|90.0|1.49|2.24|||GMR of Panel E:Panel F|||||2.24|1.49|
72468857|NCT01407276|144461144|SUPERIORITY_OR_OTHER||GMR of Panel G:Panel H|1.9|||||TWO_SIDED|90.0|1.41|2.54|||GMR of Panel G:Panel H|||||2.54|1.41|
72468858|NCT01407276|144461144|SUPERIORITY_OR_OTHER||GMR of Panel G:Panel H|1.88|||||TWO_SIDED|90.0|1.4|2.52|||GMR of Panel G:Panel H|||||2.52|1.40|
72468859|NCT01407276|144461145|SUPERIORITY_OR_OTHER||GMR of Panel A:Panel B|1.11|||||TWO_SIDED|90.0|0.87|1.42|||GMR of Panel A:Panel B|||||1.42|0.87|
72468860|NCT01407276|144461145|SUPERIORITY_OR_OTHER||GMR of Panel C:Panel D|0.75|||||TWO_SIDED|90.0|0.53|1.07|||GMR of Panel C:Panel D|||||1.07|0.53|
72468861|NCT01407276|144461145|SUPERIORITY_OR_OTHER||GMR of Panel E:Panel F|0.68|||||TWO_SIDED|90.0|0.51|0.92|||GMR of Panel E:Panel F|||||0.92|0.51|
72468862|NCT01407276|144461145|SUPERIORITY_OR_OTHER||GMR of Panel G:Panel H|0.7|||||TWO_SIDED|90.0|0.5|0.98|||GMR of Panel G:Panel H|||||0.98|0.50|
72468863|NCT01407276|144461145|SUPERIORITY_OR_OTHER||GMR of Panel G:Panel H|0.8|||||TWO_SIDED|90.0|0.57|1.12|||GMR of Panel G:Panel H|||||1.12|0.57|
72468864|NCT01407276|144461146|SUPERIORITY_OR_OTHER||GMR of Panel A:Panel B|1.06|||||TWO_SIDED|90.0|0.9|1.25|||GMR of Panel A:Panel B|||||1.25|0.90|
72468865|NCT01407276|144461146|SUPERIORITY_OR_OTHER||GMR of Panel C:Panel D|0.75|||||TWO_SIDED|90.0|0.62|0.89|||GMR of Panel C:Panel D|||||0.89|0.62|
72468866|NCT01407276|144461146|SUPERIORITY_OR_OTHER||GMR of Panel E:Panel F|0.64|||||TWO_SIDED|90.0|0.54|0.76|||GMR of Panel E:Panel F|||||0.76|0.54|
72468867|NCT01407276|144461146|SUPERIORITY_OR_OTHER||GMR of Panel G:Panel H|0.53|||||TWO_SIDED|90.0|0.39|0.71|||GMR of Panel G:Panel H|||||0.71|0.39|
72468868|NCT01407276|144461146|SUPERIORITY_OR_OTHER||GMR of Panel G:Panel H|0.51|||||TWO_SIDED|90.0|0.38|0.68|||GMR of Panel G:Panel H|||||0.68|0.38|
72468869|NCT01407276|144461147|SUPERIORITY_OR_OTHER||GMR of Panel A:Panel B|0.93|||||TWO_SIDED|90.0|0.74|1.18|||GMR of Panel A:Panel B|||||1.18|0.74|
72468870|NCT01407276|144461147|SUPERIORITY_OR_OTHER||GMR of Panel C:Panel D|0.73|||||TWO_SIDED|90.0|0.55|0.96|||GMR of Panel C:Panel D|||||0.96|0.55|
72468871|NCT01407276|144461147|SUPERIORITY_OR_OTHER||GMR of Panel E:Panel F|0.42|||||TWO_SIDED|90.0|0.33|0.54|||GMR of Panel E:Panel F|||||0.54|0.33|
72468872|NCT01407276|144461148|SUPERIORITY_OR_OTHER||GMR of Panel A:Panel B|0.86|||||TWO_SIDED|90.0|0.69|1.07|||GMR of Panel A:Panel B|||||1.07|0.69|
72468873|NCT01407276|144461148|SUPERIORITY_OR_OTHER||GMR of Panel C:Panel D|0.9|||||TWO_SIDED|90.0|0.7|1.15|||GMR of Panel C:Panel D|||||1.15|0.70|
72468874|NCT01407276|144461148|SUPERIORITY_OR_OTHER||GMR of Panel E:Panel F|0.5|||||TWO_SIDED|90.0|0.37|0.67|||GMR of Panel E:Panel F|||||0.67|0.37|
72468875|NCT01407276|144461149|SUPERIORITY_OR_OTHER||GMR of Panel A:Panel B|0.86|||||TWO_SIDED|90.0|0.69|1.07|||GMR of Panel A:Panel B|||||1.07|0.69|
72468876|NCT01407276|144461149|SUPERIORITY_OR_OTHER||GMR of Panel C:Panel D|0.9|||||TWO_SIDED|90.0|0.7|1.15|||GMR of Panel C:Panel D|||||1.15|0.70|
72468877|NCT01407276|144461149|SUPERIORITY_OR_OTHER||GMR of Panel E:Panel F|0.5|||||TWO_SIDED|90.0|0.37|0.67|||GMR of Panel E:Panel F|||||0.67|0.37|
72468878|NCT01174264|144461175|SUPERIORITY_OR_OTHER||Ratio of geometric means|1.75||||0.003|TWO_SIDED|90.0|1.3|2.34|||t-test, 2 sided|Performed on log-transformed data.||||2.34|1.30|0.003
72468879|NCT01174264|144461175|SUPERIORITY_OR_OTHER||Ratio of geometric means|1.08||||0.65|TWO_SIDED|90.0|0.81|1.44||Performed on log-transformed data.|t-test, 2 sided|||||1.44|0.81|0.65
72468880|NCT01174264|144461176|SUPERIORITY_OR_OTHER||Ratio of geometric means|1.74||||0.008|TWO_SIDED|90.0|1.25|2.42|||t-test, 2 sided|Performed on log-transformed data.||||2.42|1.25|0.008
72468881|NCT01174264|144461176|SUPERIORITY_OR_OTHER||Ratio of geometric means|1.12||||0.51|TWO_SIDED|90.0|0.84|1.49|||t-test, 2 sided|Performed on log-transformed data.||||1.49|0.84|0.51
72468882|NCT01174264|144461178|SUPERIORITY_OR_OTHER|||||||0.83|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.83
72468883|NCT01174264|144461178|SUPERIORITY_OR_OTHER|||||||0.57|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.57
72468884|NCT01174264|144461179|SUPERIORITY_OR_OTHER|||||||0.0001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.0001
72468885|NCT01174264|144461179|SUPERIORITY_OR_OTHER|||||||0.0001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.0001
72504236|NCT01025336|144539196|SUPERIORITY_OR_OTHER||Ratio of GMT|1.7|||||TWO_SIDED|95.0|1.06|2.57|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/23vPS - 23vPS)\]|Serotype 18C: Ratio of GMT (13vPnC/23vPS to 23vPS) was calculated by back transforming the mean difference between vaccine sequence/group on the logarithmic scale.||2.57|1.06|
72504237|NCT01025336|144539196|SUPERIORITY_OR_OTHER||Ratio of GMT|2.0|||||TWO_SIDED|95.0|1.5|2.78|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/23vPS - 23vPS)\]|Serotype 19A: Ratio of GMT (13vPnC/23vPS to 23vPS) was calculated by back transforming the mean difference between vaccine sequence/group on the logarithmic scale.||2.78|1.50|
72504238|NCT01025336|144539196|SUPERIORITY_OR_OTHER||Ratio of GMT|3.4|||||TWO_SIDED|95.0|2.3|5.04|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/23vPS - 23vPS)\]|Serotype 19F: Ratio of GMT (13vPnC/23vPS to 23vPS) was calculated by back transforming the mean difference between vaccine sequence/group on the logarithmic scale.||5.04|2.30|
72504239|NCT01025336|144539196|SUPERIORITY_OR_OTHER||Ratio of GMT|2.1|||||TWO_SIDED|95.0|1.37|3.37|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/23vPS - 23vPS)\]|Serotype 23F: Ratio of GMT (13vPnC/23vPS to 23vPS) was calculated by back transforming the mean difference between vaccine sequence/group on the logarithmic scale.||3.37|1.37|
72622058|NCT04003142|144774322|SUPERIORITY||LSMean difference|-1.74|STANDARD_ERROR_OF_MEAN|0.46|<|0.001||95.0|-2.63|-0.84||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 3||-0.84|-2.63|<0.001
72622059|NCT04003142|144774322|SUPERIORITY||LSMean difference|-2.4|STANDARD_ERROR_OF_MEAN|0.46|<|0.001||95.0|-3.29|-1.5||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 3||-1.50|-3.29|<0.001
72468886|NCT01174264|144461180|SUPERIORITY_OR_OTHER||Ratio of geometric means|1.16||||0.17|TWO_SIDED|90.0|0.97|1.38|||t-test, 2 sided|Performed on log-transformed data.||||1.38|0.97|0.17
72468887|NCT01174264|144461181|SUPERIORITY_OR_OTHER||Ratio of geometric means|1.13||||0.25|TWO_SIDED|90.0|0.95|1.35|||t-test, 2 sided|Performed on log-transformed data.||||1.35|0.95|0.25
72504240|NCT01025336|144539197|SUPERIORITY_OR_OTHER||Ratio of GMT|0.7|||||TWO_SIDED|95.0|0.48|0.9|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(23vPS/13vPnC - 13vPnC)\].|Serotype 1: Ratio of GMT (23vPs/13vPnC to 13vPnC) was calculated by back transforming the mean difference between vaccine sequence/group on the logarithmic scale.||0.90|0.48|
72504241|NCT01025336|144539197|SUPERIORITY_OR_OTHER||Ratio of GMT|0.8|||||TWO_SIDED|95.0|0.64|1.09|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(23vPS/13vPnC - 13vPnC)\].|Serotype 3: Ratio of GMT (23vPs/13vPnC to 13vPnC) was calculated by back transforming the mean difference between vaccine sequence/group on the logarithmic scale.||1.09|0.64|
72504242|NCT01025336|144539197|SUPERIORITY_OR_OTHER||Ratio of GMT|0.3|||||TWO_SIDED|95.0|0.2|0.44|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(23vPS/13vPnC - 13vPnC)\].|Serotype 4: Ratio of GMT (23vPs/13vPnC to 13vPnC) was calculated by back transforming the mean difference between vaccine sequence/group on the logarithmic scale.||0.44|0.20|
72504243|NCT01025336|144539197|SUPERIORITY_OR_OTHER||Ratio of GMT|0.9|||||TWO_SIDED|95.0|0.59|1.26|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(23vPS/13vPnC - 13vPnC)\].|Serotype 5: Ratio of GMT (23vPs/13vPnC to 13vPnC) was calculated by back transforming the mean difference between vaccine sequence/group on the logarithmic scale.||1.26|0.59|
72468888|NCT01174264|144461182|SUPERIORITY_OR_OTHER||Ratio of geometric means|1.22||||0.096|TWO_SIDED|90.0|1.0|1.48||Performed on log-transformed data.|t-test, 2 sided|||||1.48|1.00|0.096
72468889|NCT01174264|144461183|SUPERIORITY_OR_OTHER|||||||0.27|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.27
72504244|NCT01025336|144539197|SUPERIORITY_OR_OTHER||Ratio of GMT|0.2|||||TWO_SIDED|95.0|0.11|0.26|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(23vPS/13vPnC - 13vPnC)\].|Serotype 6A: Ratio of GMT (23vPs/13vPnC to 13vPnC) was calculated by back transforming the mean difference between vaccine sequence/group on the logarithmic scale.||0.26|0.11|
72504245|NCT01025336|144539197|SUPERIORITY_OR_OTHER||Ratio of GMT|0.8|||||TWO_SIDED|95.0|0.49|1.22|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(23vPS/13vPnC - 13vPnC)\].|Serotype 6B: Ratio of GMT (23vPs/13vPnC to 13vPnC) was calculated by back transforming the mean difference between vaccine sequence/group on the logarithmic scale.||1.22|0.49|
72504246|NCT01025336|144539197|SUPERIORITY_OR_OTHER||Ratio of GMT|1.1|||||TWO_SIDED|95.0|0.68|1.76|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(23vPS/13vPnC - 13vPnC)\].|Serotype 7F: Ratio of GMT (23vPs/13vPnC to 13vPnC) was calculated by back transforming the mean difference between vaccine sequence/group on the logarithmic scale.||1.76|0.68|
72504247|NCT01025336|144539197|SUPERIORITY_OR_OTHER||Ratio of GMT|1.5|||||TWO_SIDED|95.0|0.9|2.55|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(23vPS/13vPnC - 13vPnC)\].|Serotype 9V: Ratio of GMT (23vPs/13vPnC to 13vPnC) was calculated by back transforming the mean difference between vaccine sequence/group on the logarithmic scale.||2.55|0.90|
72504248|NCT01025336|144539197|SUPERIORITY_OR_OTHER||Ratio of GMT|1.5|||||TWO_SIDED|95.0|1.02|2.3|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(23vPS/13vPnC - 13vPnC)\].|Serotype 14: Ratio of GMT (23vPs/13vPnC to 13vPnC) was calculated by back transforming the mean difference between vaccine sequence/group on the logarithmic scale.||2.30|1.02|
72468890|NCT00267098|144461209|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.729||||0.999|TWO_SIDED|95.0|0.592|0.889||BLOCK HF is a Bayesian study;a p-value was not used. Instead, a posterior probability,representing the probability that patients with BiV pacing have lower risk of events than those with RV pacing, was calculated. A probability ≥0.95 was significant.|Posterior Distribution for HR|The posterior distribution is the set of values the BiV to RV hazard ratio can take, and its likelihood of taking such values.|The hazard ratio corresponds to the time until death, a HF urgent care event or visit in which the LVESVI endpoint was met. Data beyond missed LVESVI measurements were excluded. A 95% credible interval was used instead of a 95% confidence interval.|The null hypothesis is that patients with AV block, ejection fractions of at most 50%, and NYHA classifications of I, II, or III who receive biventricular pacing have the same rate of mortality, a heart failure urgent care visit, or significant increase in LVESVI as corresponding patients who receive right ventricular pacing. This was tested against the hypothesis that patients with BiV pacing have a lower rate of this composite endpoint than patients with right ventricular pacing.||0.889|0.592|0.9990
72468891|NCT00267098|144461210|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.843||||0.865|TWO_SIDED|95.0|0.632|1.142||BLOCK HF is a Bayesian study; thus p-values were not used. Instead, posterior probabilities, representing the probability that subjects with biventricular pacing have better outcomes, were calculated. A probability ≥ 0.95 was significant.|Posterior Distribution for HR|The posterior distribution is the set of values the BiV to RV hazard ratio for death can take, and its likelihood of taking such values.|Because BLOCK HF was a Bayesian study, a 95% credible interval was used in lieu of a 95% confidence interval. This interval reflects the set of values the Hazard Ratio can take with 95% posterior probability.|The null hypothesis is that patients with AV block, ejection fractions of at most 50%, and NYHA classifications of I, II, or III who receive biventricular pacing have the same rate of mortality as corresponding patients who receive right ventricular pacing.||1.142|0.632|0.865
72468892|NCT00267098|144461211|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.781||||0.9785|TWO_SIDED|95.0|0.615|0.991||BLOCK HF is a Bayesian study; a p-value was not used. Instead, a posterior probability, representing the probability that patients with BiV pacing have better outcomes than those with RV pacing, was calculated. A probability ≥0.95 was significant.|Posterior Distribution for HR|The posterior distribution is the set of values the BiV to RV hazard ratio can take, and its likelihood of taking such values.|Because BLOCK HF was a Bayesian study, a 95% credible interval was used in lieu of a 95% confidence interval. This interval reflects the set of values the Hazard Ratio can take with 95% posterior probability.|The null hypothesis is that patients with AV block, ejection fractions of at most 50%, and NYHA classifications of I, II, or III who receive biventricular pacing have the same rate of mortality or heart failure(HF)-related hospitalization as corresponding patients who receive right ventricular pacing. This was tested against the hypothesis that patients with biventricular pacing have a lower rate of death or first HF hospitalization than patients with right ventricular pacing.||0.991|0.615|0.9785
72468893|NCT00267098|144461212|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.695||||0.9886|TWO_SIDED|95.0|0.558|0.866||BLOCK HF is a Bayesian study; a p-value was not used. Instead, a posterior probability, representing the probability that patients with BiV pacing have better outcomes than those with RV pacing, was calculated. A probability ≥0.95 was significant.|Posterior Distribution for HR|The posterior distribution is the set of values the BiV to RV hazard ratio can take, and its likelihood of taking such values.|The hazard ratio corresponds to the time from randomization to death or a visit in which LVESVI endpoint was met. Data beyond missed LVESVI measurements were excluded. A 95% credible interval was used instead of a 95% confidence interval.|"The null hypothesis is that patients with AV block, ejection fractions of at most 50%, and NYHA classifications of I, II, or II who receive biventricular pacing have the same rate of mortality or significant increase in LVESVI as corresponding patients who receive right ventricular pacing.~This was tested against the hypothesis that patients with biventricular pacing have a lower rate of death or significant increase in LVESVI than patients with right ventricular pacing."||0.866|0.558|0.9886
72468894|NCT00267098|144461213|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.704||||0.9904|TWO_SIDED|95.0|0.522|0.947||BLOCK HF is a Bayesian study; a p-value was not used. Instead, a posterior probability, representing the probability that patients with BiV pacing have better outcomes than those with RV pacing, was calculated. A probability ≥0.95 was significant.|Posterior Distribution for HR|The posterior distribution is the set of values the BiV to RV hazard ratio can take, and its likelihood of taking such values.|Because BLOCK HF was a Bayesian study, a 95% credible interval was used in lieu of a 95% confidence interval. This interval reflects the set of values the Hazard Ratio can take with 95% posterior probability.|The null hypothesis is that patients with AV block, ejection fractions of at most 50%, and NYHA classifications of I, II, or III who receive biventricular pacing have the same rate of first heart failure(HF)-related hospitalization as corresponding patients who receive right ventricular pacing. This was tested against the hypothesis that patients with biventricular pacing have a lower rate of first HF hospitalization than patients with right ventricular pacing.||0.947|0.522|0.9904
72504249|NCT01025336|144539197|SUPERIORITY_OR_OTHER||Ratio of GMT|0.8|||||TWO_SIDED|95.0|0.52|1.14|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(23vPS/13vPnC - 13vPnC)\].|Serotype 18C: Ratio of GMT (23vPs/13vPnC to 13vPnC) was calculated by back transforming the mean difference between vaccine sequence/group on the logarithmic scale.||1.14|0.52|
72504250|NCT01025336|144539197|SUPERIORITY_OR_OTHER||Ratio of GMT|0.8|||||TWO_SIDED|95.0|0.62|1.08|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(23vPS/13vPnC - 13vPnC)\].|Serotype 19A: Ratio of GMT (23vPs/13vPnC to 13vPnC) was calculated by back transforming the mean difference between vaccine sequence/group on the logarithmic scale.||1.08|0.62|
72622060|NCT04003142|144774322|SUPERIORITY||LSMean difference|-1.84|STANDARD_ERROR_OF_MEAN|0.48|<|0.001||95.0|-2.79|-0.9||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 5||-0.90|-2.79|<0.001
72622061|NCT04003142|144774322|SUPERIORITY||LSMean difference|-2.66|STANDARD_ERROR_OF_MEAN|0.48|<|0.001|TWO_SIDED|95.0|-3.61|-1.72||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 5||-1.72|-3.61|<0.001
72622062|NCT04003142|144774322|SUPERIORITY||LSMean difference|-1.78|STANDARD_ERROR_OF_MEAN|0.47|<|0.001|TWO_SIDED|95.0|-2.71|-0.85||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 6||-0.85|-2.71|<0.001
72622063|NCT04003142|144774322|SUPERIORITY||LSMean difference|-2.66|STANDARD_ERROR_OF_MEAN|0.47|<|0.001||95.0|-3.59|-1.73||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 6||-1.73|-3.59|<0.001
72468895|NCT00267098|144461214|SUPERIORITY_OR_OTHER||BiV - RV Difference in Average Rank|-1.8||||0.637||||||BLOCK HF is a Bayesian study; a p-value was not used. Instead, a posterior probability, representing the probability that patients with BiV pacing have better outcomes than those with RV pacing, was calculated. A probability ≥0.95 was significant.|Difference in Average Ranks|The subjects' individual rates of days hospitalized for HF were ranked, with lower ranks corresponding to fewer days hospitalized for HF.|The posterior probability that the BiV - RV difference in average ranks was below 0 (denoting that the BiV arm had lower ranks than the RV arm, on average) was calculated.|The null hypothesis is that patients with AV block, ejection fractions of at most 50%, and NYHA classifications of I, II, or III who receive biventricular pacing have the same rate of days hospitalized for heart failure per year as corresponding patients who receive right ventricular pacing. This was tested against the hypothesis that patients with biventricular pacing have a lower rate of days hospitalized for HF than patients with right ventricular pacing.||||0.637
72468896|NCT00267098|144461215|SUPERIORITY_OR_OTHER||BiV - RV Difference in Average Rank|0.012||||0.591|TWO_SIDED|95.0||||BLOCK HF is a Bayesian study; thus p-values were not used. Instead, a posterior probability, representing the probability that subjects with biventricular pacing have better outcomes at 6 months, was calculated. A probability ≥0.95 was significant.|Posterior Distribution for Average Rank|Subjects' Randomization - 6 month changes in NYHA classification were ranked. The BiV - RV difference in average rank was analyzed.|Positive values reflect better outcomes over time in the BiV arm than the RV arm.|Subjects' changes in NYHA classification from randomization to 6 months were determined. The null hypothesis was that the average change among patients with biventricular pacing is equal to that of patients with right ventricular pacing.||||0.591
72468897|NCT00267098|144461215|SUPERIORITY_OR_OTHER||BiV - RV Difference in Average Rank|0.126||||0.986|TWO_SIDED|95.0||||BLOCK HF is a Bayesian study; thus p-values were not used. Instead, a posterior probability,representing the probability that subjects with biventricular pacing have better outcomes at 12 months, was calculated. A probability ≥0.95 was significant.|Posterior Distribution for Average Rank|Subjects' Randomization - 12 month changes in NYHA classification were ranked. The BiV - RV difference in average rank was analyzed.|Positive values reflect better outcomes over time in the BiV arm than the RV arm.|Subjects' changes in NYHA classification from randomization to 12 months were determined. The null hypothesis was that the average change among patients with biventricular pacing is equal to that of patients with right ventricular pacing.||||0.986
72468898|NCT00267098|144461215|SUPERIORITY_OR_OTHER||BiV - RV Difference in Average Rank|0.039||||0.726|TWO_SIDED|95.0||||BLOCK HF is a Bayesian study; thus p-values were not used. Instead, a posterior probability,representing the probability that subjects with biventricular pacing have better outcomes at 12 months, was calculated. A probability ≥0.95 was significant.|Posterior Distribution for Average Rank|Subjects' Randomization - 18 month changes in NYHA classification were ranked. The BiV - RV difference in average rank was analyzed.|Positive values reflect better outcomes over time in the BiV arm than the RV arm.|Subjects' changes in NYHA classification from randomization to 18 months were determined. The null hypothesis was that the average change among patients with biventricular pacing is equal to that of patients with right ventricular pacing.||||0.726
72468899|NCT00267098|144461215|SUPERIORITY_OR_OTHER||BiV - RV Difference in Average Rank|0.035||||0.701|TWO_SIDED|95.0||||BLOCK HF is a Bayesian study; thus p-values were not used. Instead, a posterior probability,representing the probability that subjects with biventricular pacing have better outcomes at 24 months, was calculated. A probability ≥0.95 was significant.|Posterior Distribution for Average Rank|Subjects' Randomization - 24 month changes in NYHA classification were ranked. The BiV - RV difference in average rank was analyzed.|Positive values reflect better outcomes over time in the BiV arm than the RV arm.|Subjects' changes in NYHA classification from randomization to 24 months were determined. The null hypothesis was that the average change among patients with biventricular pacing is equal to that of patients with right ventricular pacing.||||0.701
72468900|NCT00267098|144461216|SUPERIORITY_OR_OTHER||BiV - RV Difference in Average Rank|0.002||||0.534|TWO_SIDED|95.0||||BLOCK HF is a Bayesian study; thus p-values were not used. Instead, a posterior probability, representing the probability that subjects with biventricular pacing have better outcomes at 6 months, was calculated. A probability ≥0.95 was significant.|Posterior Distribution for Average Rank|Subjects' Randomization - 6 month change in HF Stage were ranked. The BiV - RV difference in average rank was analyzed.|Positive values reflect better outcomes over time in the BiV arm than the RV arm.|Subjects' changes in HF stage from randomization to 6 months were determined. The null hypothesis was that the average change among patients with biventricular pacing is equal to that of patients with right ventricular pacing.||||0.534
72468901|NCT00267098|144461216|SUPERIORITY_OR_OTHER||BiV - RV Difference in Average Rank|0.026||||0.825|TWO_SIDED|95.0||||BLOCK HF is a Bayesian study; thus p-values were not used. Instead, a posterior probability,representing the probability that subjects with biventricular pacing have better outcomes at 12 months, was calculated. A probability ≥0.95 was significant.|Posterior Distribution for Average Rank|Subjects' Randomization - 12 month changes in HF Stage were ranked. The BiV - RV difference in average rank was analyzed.|Positive values reflect better outcomes over time in the BiV arm than the RV arm.|Subjects' change in HF stage from randomization to 12 months were determined. The null hypothesis was that the average change among patients with biventricular pacing is equal to that of patients with right ventricular pacing.||||0.825
72504251|NCT01025336|144539197|SUPERIORITY_OR_OTHER||Ratio of GMT|1.3|||||TWO_SIDED|95.0|0.89|1.98|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(23vPS/13vPnC - 13vPnC)\].|Serotype 19F: Ratio of GMT (23vPs/13vPnC to 13vPnC) was calculated by back transforming the mean difference between vaccine sequence/group on the logarithmic scale.||1.98|0.89|
72468902|NCT00267098|144461216|SUPERIORITY_OR_OTHER||BiV - RV Difference in Average Rank|0.01||||0.651|TWO_SIDED|95.0||||BLOCK HF is a Bayesian study; thus p-values were not used. Instead, a posterior probability,representing the probability that subjects with biventricular pacing have better outcomes at 18 months, was calculated. A probability ≥0.95 was significant.|Posterior Distribution for Average Rank|Subjects' Randomization - 18 month changes in HF Stage were ranked. The BiV - RV difference in average rank was analyzed.|Positive values denote that the BiV arm had better outcomes over time than the RV arm.|Subjects' changes in HF stage from randomization to 18 months were determined. The null hypothesis was that the average change among patients with biventricular pacing is equal to that of patients with right ventricular pacing.||||0.651
72468903|NCT00267098|144461216|SUPERIORITY_OR_OTHER||BiV - RV Difference in Average Rank|-0.006||||0.425|TWO_SIDED|95.0||||BLOCK HF is a Bayesian study; thus p-values were not used. Instead, a posterior probability,representing the probability that subjects with biventricular pacing have better outcomes at 24 months, was calculated. A probability ≥0.95 was significant.|Posterior Distribution for Average Rank|Subjects' Randomization - 24 month changes in HF Stage were ranked. The BiV - RV difference in average rank was analyzed.|Positive values denote better outcomes over time in the BiV arm than the RV arm.|Subjects' changes in HF stage from randomization to 24 months were determined. The null hypothesis was that the average change among patients with biventricular pacing is equal to that of patients with right ventricular pacing.||||0.425
72468904|NCT00267098|144461220|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.7||||0.9976|TWO_SIDED|95.0||||BLOCK HF is a Bayesian study; a p-value was not used. Instead, a posterior probability, representing the probability that patients with BiV pacing have better outcomes than those with RV pacing, was calculated. A probability ≥0.95 was significant.|Posterior Probability of Mean QOL Change|The posterior distribution for the BiV - RV difference in mean QOL score improvement from randomization to 6 months was determined.||"The null hypothesis is that patients with AV block, ejection fractions of at most 50%, and NYHA classifications of I, II, or III who receive biventricular pacing have the same average change in QOL score from randomization to 6 months as corresponding patients who receive right ventricular pacing.~This was tested against the hypothesis that patients with biventricular pacing have a greater reduction (and thus improvement) in QOL score at 6 months than patients with right ventricular pacing."||||0.9976
72468905|NCT00267098|144461221|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.0||||0.9641|TWO_SIDED|95.0||||BLOCK HF is a Bayesian study; a p-value was not used. Instead, a posterior probability, representing the probability that patients with BiV pacing have better outcomes than those with RV pacing, was calculated. A probability ≥0.95 was significant.|Posterior Probability of Mean QOL Change|The posterior distribution for the BiV - RV difference in mean QOL score improvement from randomization to 12 months was determined.||"The null hypothesis is that patients with AV block, ejection fractions of at most 50%, and NYHA classifications of I, II, or III who receive biventricular pacing have the same average change in QOL score from randomization to 12 months as corresponding patients who receive right ventricular pacing.~This was tested against the hypothesis that patients with biventricular pacing have a greater reduction (and thus improvement) in QOL score at 12 months than patients with right ventricular pacing."||||0.9641
72468906|NCT00267098|144461222|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.8||||0.8416|TWO_SIDED|95.0||||BLOCK HF is a Bayesian study; a p-value was not used. Instead, a posterior probability, representing the probability that patients with BiV pacing have better outcomes than those with RV pacing, was calculated. A probability ≥0.95 was significant.|Posterior Probability of Mean QOL Change|The parameter of interest was the BiV - RV difference in mean QOL change from randomization to 18 months.||"The null hypothesis is that patients with AV block, ejection fractions of at most 50%, and NYHA classifications of I, II, or III who receive biventricular pacing have the same average change in QOL score from randomization to 18 months as corresponding patients who receive right ventricular pacing.~This was tested against the hypothesis that patients with biventricular pacing have a greater reduction (and thus improvement) in QOL score at 18 months than patients with right ventricular pacing."||||0.8416
72468907|NCT00267098|144461223|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.1||||0.727|TWO_SIDED|95.0||||BLOCK HF is a Bayesian study; a p-value was not used. Instead, a posterior probability, representing the probability that patients with BiV pacing have better outcomes than those with RV pacing, was calculated. A probability ≥0.95 was significant.|Posterior Probability of Mean QOL Change|The posterior distribution for the BiV - RV difference in mean QOL score improvement from randomization to 24 months was determined.||"The null hypothesis is that patients with AV block, ejection fractions of at most 50%, and NYHA classifications of I, II, or III who receive biventricular pacing have the same average change in QOL score from randomization to 24 months as corresponding patients who receive right ventricular pacing.~This was tested against the hypothesis that patients with biventricular pacing have a greater reduction (and thus improvement) in QOL score at 24 months than patients with right ventricular pacing."||||0.7270
72504252|NCT01025336|144539197|SUPERIORITY_OR_OTHER||Ratio of GMT|0.4|||||TWO_SIDED|95.0|0.26|0.59|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(23vPS/13vPnC - 13vPnC)\].|Serotype 23F: Ratio of GMT (23vPs/13vPnC to 13vPnC) was calculated by back transforming the mean difference between vaccine sequence/group on the logarithmic scale.||0.59|0.26|
72622064|NCT04003142|144774322|SUPERIORITY||LSMean difference|-1.8|STANDARD_ERROR_OF_MEAN|0.49|<|0.001||95.0|-2.77|-0.83||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 7||-0.83|-2.77|<0.001
72622065|NCT04003142|144774322|SUPERIORITY||LSMean difference|-2.34|STANDARD_ERROR_OF_MEAN|0.49|<|0.001||95.0|-3.3|-1.37||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 7||-1.37|-3.30|<0.001
72622066|NCT04003142|144774322|SUPERIORITY||LSMean difference|-1.76|STANDARD_ERROR_OF_MEAN|0.52|<|0.001|TWO_SIDED|95.0|-2.79|-0.74||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 8||-0.74|-2.79|<0.001
72394777|NCT03765918|144296129|OTHER|Based on a cLDA model with the PRO scores as the response variable with covariates for treatment by study visit interaction, and stratification factors by primary tumor site, tumor stage, and PD-L1 status.|Difference in Least Square Means|-2.75||||0.1654|TWO_SIDED|95.0|-6.65|1.14||Two-sided p-value based on cLDA model.|cLDA model|||||1.14|-6.65|0.1654
72468908|NCT00267098|144461224|SUPERIORITY_OR_OTHER||Posterior BiV - RV Mean Difference|3.334|||||TWO_SIDED|95.0|1.886|4.815||BLOCK HF is a Bayesian study; a p-value was not used since it is a non-Bayesian statistical tool. Instead, a posterior distribution representing the set of possible values for the BiV - RV difference in improvement in LVEF through 6 months was used|Bayesian Credible Interval||Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean LVEF change through 6 months.|"The null hypothesis is that patients with AV block, ejection fractions of at most 50%, and NYHA classifications of I, II, or III who receive biventricular pacing have the same average change in LVEF from randomization to 6 months as corresponding patients who receive right ventricular pacing.~This was tested against the hypothesis that patients with biventricular pacing have a different change in LVEF from randomization to 6 months than patients with right ventricular pacing."||4.815|1.886|
72468909|NCT00267098|144461225|SUPERIORITY_OR_OTHER||Posterior BiV - RV Mean Difference|3.232|||||TWO_SIDED|95.0|1.618|4.839||BLOCK HF is a Bayesian study; a p-value was not used since it is a non-Bayesian statistical tool. Instead, a posterior distribution representing the set of possible values for the BiV - RV difference in improvement in LVEF through 12 months was used|Bayesian Credible Interval||Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean LVEF change through 12 months.|The null hypothesis is that patients with AV block, ejection fractions of at most 50%, and NYHA classifications of I, II, or III who receive biventricular pacing have the same average change in LVEF from randomization to 12 months as corresponding patients who receive right ventricular pacing. This was tested against the hypothesis that patients with biventricular pacing have a different change in LVEF from randomization to 12 months than patients with right ventricular pacing.||4.839|1.618|
72504253|NCT01025336|144539198|SUPERIORITY_OR_OTHER||geometric mean fold rise|1.0|||||TWO_SIDED|95.0|0.85|1.22|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 1: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||1.22|0.85|
72504254|NCT01025336|144539198|SUPERIORITY_OR_OTHER||geometric mean fold rise|1.0|||||TWO_SIDED|95.0|0.82|1.1|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 3: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||1.10|0.82|
72504255|NCT01025336|144539198|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.5|||||TWO_SIDED|95.0|0.41|0.69|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 4: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||0.69|0.41|
72504256|NCT01025336|144539198|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.8|||||TWO_SIDED|95.0|0.67|0.87|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 5: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||0.87|0.67|
72504257|NCT01025336|144539198|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.6|||||TWO_SIDED|95.0|0.48|0.79|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 6A: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||0.79|0.48|
72504258|NCT01025336|144539198|SUPERIORITY_OR_OTHER||geometric mean fold rise|1.7|||||TWO_SIDED|95.0|1.32|2.19|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 6B: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||2.19|1.32|
72504259|NCT01025336|144539198|SUPERIORITY_OR_OTHER||geometric mean fold rise|1.7|||||TWO_SIDED|95.0|1.24|2.26|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 7F: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||2.26|1.24|
72504260|NCT01025336|144539198|SUPERIORITY_OR_OTHER||geometric mean fold rise|2.1|||||TWO_SIDED|95.0|1.48|2.95|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 9V: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||2.95|1.48|
72504261|NCT01025336|144539198|SUPERIORITY_OR_OTHER||geometric mean fold rise|1.6|||||TWO_SIDED|95.0|1.23|2.05|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 14: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||2.05|1.23|
72504262|NCT01025336|144539198|SUPERIORITY_OR_OTHER||geometric mean fold rise|1.0|||||TWO_SIDED|95.0|0.82|1.19|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 18C: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||1.19|0.82|
72622067|NCT04003142|144774322|SUPERIORITY||LSMean difference|-2.38|STANDARD_ERROR_OF_MEAN|0.52|<|0.001|TWO_SIDED|95.0|-3.4|-1.35||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 8||-1.35|-3.40|<0.001
72622068|NCT04003142|144774322|SUPERIORITY||LSMean difference|-1.65|STANDARD_ERROR_OF_MEAN|0.54||0.002||95.0|-2.71|-0.59||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 9||-0.59|-2.71|0.002
72394778|NCT03765918|144296130|OTHER|Based on a cLDA model with the PRO scores as the response variable with covariates for treatment by study visit interaction, and stratification factors by primary tumor site, tumor stage, and PD-L1 status.|Difference in Least Square Means|0.26||||0.9117|TWO_SIDED|95.0|-4.29|4.8||Two-sided p-value based on cLDA model.|cLDA model|||||4.80|-4.29|0.9117
72394779|NCT03765918|144296131|OTHER|Based on a cLDA model with the PRO scores as the response variable with covariates for treatment by study visit interaction, and stratification factors by primary tumor site, tumor stage, and PD-L1 status.|Difference in Least Square Means|-2.22||||0.2808|TWO_SIDED|95.0|-6.25|1.82||Two-sided p-value based on cLDA model.|cLDA model|||||1.82|-6.25|0.2808
72394780|NCT03765918|144296132|OTHER|Based on a cLDA model with the PRO scores as the response variable with covariates for treatment by study visit interaction, and stratification factors by primary tumor site, tumor stage, and PD-L1 status.|Difference in Least Square Means|-2.77||||0.1577|TWO_SIDED|95.0|-6.62|1.08||Two-sided p-value based on cLDA model.|cLDA model|||||1.08|-6.62|0.1577
72394781|NCT03765918|144296133|OTHER|Based on a cLDA model with the PRO scores as the response variable with covariates for treatment by study visit interaction, and stratification factors by primary tumor site, tumor stage, and PD-L1 status.|Difference in Least Square Means|-2.81||||0.2485|TWO_SIDED|95.0|-7.59|1.97||Two-sided p-value based on cLDA model.|cLDA model|||||1.97|-7.59|0.2485
72394782|NCT03765918|144296134|OTHER|Based on a cLDA model with the PRO scores as the response variable with covariates for treatment by study visit interaction, and stratification factors by primary tumor site, tumor stage, and PD-L1 status.|Difference in Least Square Means|-3.03||||0.1364|TWO_SIDED|95.0|-7.03|0.96||Two-sided p-value based on cLDA model.|cLDA model|||||0.96|-7.03|0.1364
72394783|NCT03765918|144296140|SUPERIORITY|Hazard ratio (HR) and associated 95% confidence interval (CI) were based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by primary tumor site and tumor stage.|Hazard Ratio (HR)|0.73||||0.00411|TWO_SIDED|95.0|0.58|0.92|||Stratified Log Rank|One-sided p-value was based on log-rank test stratified by primary tumor site and tumor stage.||||0.92|0.58|0.00411
72394784|NCT03765918|144296141|SUPERIORITY|HR and associated 95% CI were based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by primary tumor site and tumor stage.|Hazard Ratio (HR)|0.66||||0.00217|TWO_SIDED|95.0|0.49|0.88|||Stratified Log Rank|One-sided p-value based on log-rank test stratified by primary tumor site and tumor stage.||||0.88|0.49|0.00217
72394785|NCT03765918|144296142|SUPERIORITY|HR and associated 95% CI were based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by primary tumor site and tumor stage.|Hazard Ratio (HR)|0.7||||0.0014|TWO_SIDED|95.0|0.55|0.89|||Stratified Log Rank|One-sided p-value based on log-rank test stratified by primary tumor site and tumor stage.||||0.89|0.55|0.00140
72394786|NCT00356369|144296148|NON_INFERIORITY|Criterion indicative of non-inferiority: Lower limit of the standardized asymptotic 95% confidence interval (CI) for the difference between MenACWY-TT and (minus) MenACWY in the percentage of subjects with bactericidal vaccine response was greater than (\>) -15%.|Difference in % for rSBA-MenA antibodies|13.0|||||TWO_SIDED|95.0|3.52|23.5||||||To evaluate the non-inferiority of the vaccine response\* induced by the MenACWY-TT vaccine when compared to the licensed MenACWY vaccine.||23.5|3.52|
72504263|NCT01025336|144539198|SUPERIORITY_OR_OTHER||geometric mean fold rise|1.2|||||TWO_SIDED|95.0|1.07|1.46|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 19A: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||1.46|1.07|
72394787|NCT00356369|144296148|NON_INFERIORITY|Criterion indicative of non-inferiority: Lower limit of the standardized asymptotic 95% confidence interval (CI) for the difference between MenACWY-TT and (minus) MenACWY in the percentage of subjects with bactericidal vaccine response was ≥ -12%.|Difference in % for rSBA-MenC antibodies|4.18|||||TWO_SIDED|95.0|-1.03|11.36||||||To evaluate the non-inferiority of the vaccine response\* induced by the MenACWY-TT vaccine when compared to the licensed MenACWY vaccine.||11.36|-1.03|
72394788|NCT00356369|144296148|NON_INFERIORITY|Criterion indicative of non-inferiority: Lower limit of the standardized asymptotic 95% confidence interval (CI) for the difference between MenACWY-TT and (minus) MenACWY in the percentage of subjects with bactericidal vaccine response was ≥ -12%.|Difference in%for rSBA-MenW-135 antibody|4.58|||||TWO_SIDED|95.0|-0.07|11.49||||||To evaluate the non-inferiority of the vaccine response\* induced by the MenACWY-TT vaccine when compared to the licensed MenACWY vaccine.||11.49|-0.07|
72622069|NCT04003142|144774322|SUPERIORITY||LSMean difference|-2.51|STANDARD_ERROR_OF_MEAN|0.54|<|0.001||95.0|-3.57|-1.45||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 9||-1.45|-3.57|<0.001
72394789|NCT00356369|144296148|NON_INFERIORITY|Criterion indicative of non-inferiority: Lower limit of the standardized asymptotic 95% confidence interval (CI) for the difference between MenACWY-TT and (minus) MenACWY in the percentage of subjects with bactericidal vaccine response was ≥ -12%.|Difference in % for rSBA-MenY antibodies|8.05|||||TWO_SIDED|95.0|1.72|16.17||||||To evaluate the non-inferiority of the vaccine response\* induced by the MenACWY-TT vaccine when compared to the licensed MenACWY vaccine.||16.17|1.72|
72394790|NCT00356369|144296149|NON_INFERIORITY|Criterion indicative of non-inferiority: Upper limit of the standardized asymptotic 95% CI on the difference between MenACWY- TT and (minus) MenACWY in the incidence of Grade 3 systemic symptoms was below 5%.|Difference in % Grade 3 general symptoms|1.34|||||TWO_SIDED|95.0|-1.64|3.09||||||To evaluate the non-inferiority of the MenACWY-TT conjugate vaccine when compared to the licensed MenACWY vaccine in terms of the incidence of any Grade 3 systemic symptom within 4 days after vaccination.||3.09|-1.64|
72394791|NCT02408315|144296180|NON_INFERIORITY|Estimates obtained from Kaplan-Meier method and results of Log-rank test. P-value for non-inferiority hypothesis based on Cox proportional hazards model (H0: HR ≤ 0.74 vs. HA: HR \> .74), p-value \< .05 provides evidence to reject inferiority and conclude BM is non-inferior to VM.||||||0.663|||||||Cox proportional|||||||0.663
72504264|NCT01025336|144539198|SUPERIORITY_OR_OTHER||geometric mean fold rise|2.1|||||TWO_SIDED|95.0|1.56|2.8|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 19F: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||2.80|1.56|
72504265|NCT01025336|144539198|SUPERIORITY_OR_OTHER||geometric mean fold rise|1.1|||||TWO_SIDED|95.0|0.89|1.48|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 23F: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||1.48|0.89|
72504266|NCT01025336|144539199|SUPERIORITY_OR_OTHER||Ratio of GMT|0.7|||||TWO_SIDED|95.0|0.48|0.92|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(23vPS/13vPnC-13vPnC)\].|Serotype 1: Ratio of GMT (23vPS/13vPnC to 13vPnC) was calculated by back transforming the mean difference between vaccine sequence/group on the logarithmic scale.||0.92|0.48|
72504267|NCT01025336|144539199|SUPERIORITY_OR_OTHER||Ratio of GMT|1.0|||||TWO_SIDED|95.0|0.76|1.28|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(23vPS/13vPnC-13vPnC)\].|Serotype 3: Ratio of GMT (23vPS/13vPnC to 13vPnC) was calculated by back transforming the mean difference between vaccine sequence/group on the logarithmic scale.||1.28|0.76|
72468910|NCT00267098|144461226|SUPERIORITY_OR_OTHER||Posterior BiV - RV Mean Difference|2.24|||||TWO_SIDED|95.0|0.419|4.066||BLOCK HF is a Bayesian study; a p-value was not used since it is a non-Bayesian statistical tool. Instead, a posterior distribution representing the set of possible values for the BiV - RV difference in improvement in LVEF at 18 months was used.|Bayesian Credible Interval||Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean LVEF change through 18 months.|The null hypothesis is that patients with AV block, ejection fractions of at most 50%, and NYHA classifications of I, II, or III who receive biventricular pacing have the same average change in LVEF from randomization to 18 months as corresponding patients who receive right ventricular pacing. This was tested against the hypothesis that patients with biventricular pacing have a different change in LVEF from randomization to 18 months than patients with right ventricular pacing.||4.066|0.419|
72504268|NCT01025336|144539199|SUPERIORITY_OR_OTHER||Ratio of GMT|1.4|||||TWO_SIDED|95.0|0.88|2.22|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(23vPS/13vPnC-13vPnC)\].|Serotype 4: Ratio of GMT (23vPS/13vPnC to 13vPnC) was calculated by back transforming the mean difference between vaccine sequence/group on the logarithmic scale.||2.22|0.88|
72504269|NCT01025336|144539199|SUPERIORITY_OR_OTHER||Ratio of GMT|1.4|||||TWO_SIDED|95.0|0.93|1.95|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(23vPS/13vPnC-13vPnC)\].|Serotype 5: Ratio of GMT (23vPS/13vPnC to 13vPnC) was calculated by back transforming the mean difference between vaccine sequence/group on the logarithmic scale.||1.95|0.93|
72504270|NCT01025336|144539199|SUPERIORITY_OR_OTHER||Ratio of GMT|0.4|||||TWO_SIDED|95.0|0.27|0.66|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(23vPS/13vPnC-13vPnC)\].|Serotype 6A: Ratio of GMT (23vPS/13vPnC to 13vPnC) was calculated by back transforming the mean difference between vaccine sequence/group on the logarithmic scale.||0.66|0.27|
72504271|NCT01025336|144539199|SUPERIORITY_OR_OTHER||Ratio of GMT|1.0|||||TWO_SIDED|95.0|0.64|1.56|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(23vPS/13vPnC-13vPnC)\].|Serotype 6B: Ratio of GMT (23vPS/13vPnC to 13vPnC) was calculated by back transforming the mean difference between vaccine sequence/group on the logarithmic scale.||1.56|0.64|
72504272|NCT01025336|144539199|SUPERIORITY_OR_OTHER||Ratio of GMT|1.9|||||TWO_SIDED|95.0|1.14|3.04|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(23vPS/13vPnC-13vPnC)\].|Serotype 7F: Ratio of GMT (23vPS/13vPnC to 13vPnC) was calculated by back transforming the mean difference between vaccine sequence/group on the logarithmic scale.||3.04|1.14|
72504273|NCT01025336|144539199|SUPERIORITY_OR_OTHER||Ratio of GMT|1.7|||||TWO_SIDED|95.0|1.01|2.85|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(23vPS/13vPnC-13vPnC)\].|Serotype 9V: Ratio of GMT (23vPS/13vPnC to 13vPnC) was calculated by back transforming the mean difference between vaccine sequence/group on the logarithmic scale.||2.85|1.01|
72504274|NCT01025336|144539199|SUPERIORITY_OR_OTHER||Ratio of GMT|1.9|||||TWO_SIDED|95.0|1.26|2.87|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(23vPS/13vPnC-13vPnC)\].|Serotype 14: Ratio of GMT (23vPS/13vPnC to 13vPnC) was calculated by back transforming the mean difference between vaccine sequence/group on the logarithmic scale.||2.87|1.26|
72504275|NCT01025336|144539199|SUPERIORITY_OR_OTHER||Ratio of GMT|0.8|||||TWO_SIDED|95.0|0.57|1.19|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(23vPS/13vPnC-13vPnC)\].|Serotype 18C: Ratio of GMT (23vPS/13vPnC to 13vPnC) was calculated by back transforming the mean difference between vaccine sequence/group on the logarithmic scale.||1.19|0.57|
72565132|NCT00107042|144661884|SUPERIORITY_OR_OTHER|||||||0.0608|||||||Wilcoxon (Mann-Whitney)|||Analysis included an assessment of quantitative titer values in each of the two arms using confidence intervals and examining the frequency distributions of the titers in each arm. Transformations were considered (log10) for the titers based on the distributional properties observed in the sample, with the goal of attaining approximate normality of the transformed data.||||0.0608
72565133|NCT00107042|144661884|SUPERIORITY_OR_OTHER||Mean response|2.29|||||TWO_SIDED|95.0|2.05|2.53|||95% confidence interval|||"Two-sided confidence intervals (CI) were calculated for both the Recombivax and Twinrix arms. The CI for the Recombivax arm is presented here."||2.53|2.05|
72565134|NCT00107042|144661884|SUPERIORITY_OR_OTHER||Response rate|2.58|||||TWO_SIDED|95.0|2.4|2.76|||95% confidence interval|||"Two-sided confidence intervals (CI) were calculated for both the Recombivax and Twinrix arms. The CI for the Twinrix arm is presented here."||2.76|2.40|
72622070|NCT04003142|144774322|SUPERIORITY||LSMean difference|-1.91|STANDARD_ERROR_OF_MEAN|0.54|<|0.001||95.0|-2.96|-0.86||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 10||-0.86|-2.96|<0.001
72394792|NCT01985867|144296193|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|1.19||||0.399|TWO_SIDED|95.0|0.24|1.5|||risk analysis (prospective)|||||1.5|0.24|0.399
72394793|NCT01985867|144296194|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|0.2||||0.589|TWO_SIDED|95.0|-0.6|0.7|||Wilcoxon (Mann-Whitney)|||||0.7|-0.6|0.589
72504276|NCT01025336|144539199|SUPERIORITY_OR_OTHER||Ratio of GMT|1.0|||||TWO_SIDED|95.0|0.75|1.31|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(23vPS/13vPnC-13vPnC)\].|Serotype 19A: Ratio of GMT (23vPS/13vPnC to 13vPnC) was calculated by back transforming the mean difference between vaccine sequence/group on the logarithmic scale.||1.31|0.75|
72394794|NCT01985867|144296195|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|2.0||||0.005|TWO_SIDED|95.0|0.5|4.0|||Wilcoxon (Mann-Whitney)|||||4.0|0.5|0.005
72504277|NCT01025336|144539199|SUPERIORITY_OR_OTHER||Ratio of GMT|1.4|||||TWO_SIDED|95.0|0.93|2.04|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(23vPS/13vPnC-13vPnC)\].|Serotype 19F: Ratio of GMT (23vPS/13vPnC to 13vPnC) was calculated by back transforming the mean difference between vaccine sequence/group on the logarithmic scale.||2.04|0.93|
72565135|NCT00107042|144661887|SUPERIORITY_OR_OTHER||Regression coefficient|0.2455|STANDARD_ERROR_OF_MEAN|0.1757||0.1667|||||||Regression, Linear|||This is a regression analysis for testing the effect of treatment arm (Recombivax vs. Twinrix) on vaccine response as measured in log10 titers. The null hypothesis is no difference between groups.||||0.1667
72565136|NCT00107042|144661887|SUPERIORITY_OR_OTHER||Regression coefficent|-0.0025|STANDARD_ERROR_OF_MEAN|0.1792||0.989||95.0|||||Regression, Linear|||This is a regression analysis for testing the effect of site effect(Other sites vs. Baltimore) on vaccine response as measured in log10 titers. The null hypothesis is no difference between groups.||||0.9890
72394795|NCT01985867|144296196|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|0.0||||0.659|TWO_SIDED|95.0|0.0|0.0|||Wilcoxon (Mann-Whitney)|||||0.0|0.0|0.659
72394796|NCT01985867|144296197|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|0.0||||0.79|TWO_SIDED|95.0|0.0|0.0|||Wilcoxon (Mann-Whitney)|||||0.0|0.0|0.790
72394797|NCT01985867|144296198|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|0.0||||0.698|TWO_SIDED|95.0|0.0|0.0|||Wilcoxon (Mann-Whitney)|||||0.0|0.0|0.698
72394798|NCT01985867|144296199|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|2.3||||0.12|TWO_SIDED|95.0|0.9|6.2|||risk analysis (prospective)|||||6.2|0.9|0.120
72394799|NCT01985867|144296200|SUPERIORITY_OR_OTHER_LEGACY|||||||0.116|||||||Wilcoxon (Mann-Whitney)|||||||0.116
72504278|NCT01025336|144539199|SUPERIORITY_OR_OTHER||Ratio of GMT|0.8|||||TWO_SIDED|95.0|0.5|1.15|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(23vPS/13vPnC-13vPnC)\].|Serotype 23F: Ratio of GMT (23vPS/13vPnC to 13vPnC) was calculated by back transforming the mean difference between vaccine sequence/group on the logarithmic scale.||1.15|0.50|
72504279|NCT01025336|144539200|SUPERIORITY_OR_OTHER||geometric mean fold rise|1.2|||||TWO_SIDED|95.0|1.03|1.31|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 1: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||1.31|1.03|
72622071|NCT04003142|144774322|SUPERIORITY||LSMean difference|-2.65|STANDARD_ERROR_OF_MEAN|0.53|<|0.001||95.0|-3.69|-1.6||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 10||-1.60|-3.69|<0.001
72394800|NCT01985867|144296201|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|0.5||||0.612|TWO_SIDED|95.0|-0.6|0.8|||Wilcoxon (Mann-Whitney)|||||0.8|-0.6|0.612
72394801|NCT01985867|144296202|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|1.0||||0.004|TWO_SIDED|95.0|0.0|2.0|||Wilcoxon (Mann-Whitney)|||||2.0|0.0|0.004
72394802|NCT01985867|144296203|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|0.0||||0.708|TWO_SIDED|95.0|0.0|0.0|||Wilcoxon (Mann-Whitney)|||||0.0|0.0|0.708
72394803|NCT01985867|144296204|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|0.0||||0.522|TWO_SIDED|95.0|-1.0|1.0|||Wilcoxon (Mann-Whitney)|||||1.0|-1.0|0.522
72394804|NCT01985867|144296205|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|0.0||||0.185|TWO_SIDED|95.0|0.0|1.0|||Wilcoxon (Mann-Whitney)|||||1.0|0.0|0.185
72394805|NCT01985867|144296206|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|0.0||||0.973|TWO_SIDED|95.0|0.0|0.0|||Wilcoxon (Mann-Whitney)|||||0.0|0.0|0.973
72394806|NCT01985867|144296207|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|0.0||||0.642|TWO_SIDED|95.0|0.0|0.0|||Wilcoxon (Mann-Whitney)|||||0.0|0.0|0.642
72394807|NCT03530098|144296220|SUPERIORITY||Odds Ratio (OR)|-0.59||||0.04|TWO_SIDED|95.0|-1.14|-0.04|||t-test, 2 sided|||||-0.04|-1.14|0.04
72394808|NCT03530098|144296221|OTHER|||||||0.001|||||||Wilcoxon rank-sum test|||||||0.001
72394809|NCT00555321|144296252|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|32.9|||||TWO_SIDED|95.0|16.1|49.8|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|||49.8|16.1|
72394810|NCT00555321|144296252|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|26.6|||||TWO_SIDED|95.0|9.6|43.5|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|||43.5|9.6|
72394811|NCT00555321|144296252|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|31.8|||||TWO_SIDED|95.0|14.8|48.5|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|||48.5|14.8|
72394812|NCT00555321|144296252|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.0|||||TWO_SIDED|95.0|-8.7|29.6|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|||29.6|-8.7|
72394813|NCT00555321|144296252|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.7|||||TWO_SIDED|95.0|-15.3|23.2|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|||23.2|-15.3|
72394814|NCT00555321|144296252|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.9|||||TWO_SIDED|95.0|-9.8|28.4|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|||28.4|-9.8|
72394815|NCT00555321|144296253|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.5|||||TWO_SIDED|95.0|-12.9|8.7|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 6||8.7|-12.9|
72394816|NCT00555321|144296253|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.9|||||TWO_SIDED|95.0|-13.6|8.5|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 6||8.5|-13.6|
72394817|NCT00555321|144296253|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.9|||||TWO_SIDED|95.0|-23.8|1.5|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 6||1.5|-23.8|
72394818|NCT00555321|144296253|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||||95.0|||||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 6||||
72394819|NCT00555321|144296253|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|||||TWO_SIDED|95.0|-12.1|11.3|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 6||11.3|-12.1|
72394820|NCT00555321|144296253|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.4|||||TWO_SIDED|95.0|-22.9|4.1|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 6||4.1|-22.9|
72394821|NCT00555321|144296253|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.5|||||TWO_SIDED|95.0|-12.9|8.7|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 12||8.7|-12.9|
72394822|NCT00555321|144296253|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.1|||||TWO_SIDED|95.0|-18.1|5.4|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 12||5.4|-18.1|
72394823|NCT00555321|144296253|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-25.1|||||TWO_SIDED|95.0|-38.9|-9.5|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 12||-9.5|-38.9|
72394824|NCT00555321|144296253|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.0|||||TWO_SIDED|95.0|-9.9|14.4|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 12||14.4|-9.9|
72394825|NCT00555321|144296253|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.7|||||TWO_SIDED|95.0|-15.5|10.7|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 12||10.7|-15.5|
72394826|NCT00555321|144296253|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-20.7|||||TWO_SIDED|95.0|-35.5|-4.1|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 12||-4.1|-35.5|
72394827|NCT00555321|144296254|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.2|||||TWO_SIDED|95.0|-14.5|15.3|||||For 95% CI of difference, normal approximation was used if N\>=5 in both arms. Otherwise exact method was used.|||15.3|-14.5|
72394828|NCT00555321|144296254|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.9|||||TWO_SIDED|95.0|-25.7|8.8|||||For 95% CI of difference, normal approximation was used if N\>=5 in both arms. Otherwise exact method was used.|||8.8|-25.7|
72394829|NCT00555321|144296254|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.7|||||TWO_SIDED|95.0|-13.2|17.5|||||For 95% CI of difference, normal approximation was used if N\>=5 in both arms. Otherwise exact method was used.|||17.5|-13.2|
72394830|NCT00555321|144296254|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.8|||||TWO_SIDED|95.0|-18.1|13.1|||||For 95% CI of difference, normal approximation was used if N\>=5 in both arms. Otherwise exact method was used.|||13.1|-18.1|
72394831|NCT00555321|144296254|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.0|||||TWO_SIDED|95.0|-29.4|6.2|||||For 95% CI of difference, normal approximation was used if N\>=5 in both arms. Otherwise exact method was used.|||6.2|-29.4|
72468911|NCT00267098|144461227|SUPERIORITY_OR_OTHER||Posterior BiV - RV Mean Difference|3.623|||||TWO_SIDED|95.0|1.623|5.604||BLOCK HF is a Bayesian study; a p-value was not used since it is a non-Bayesian statistical tool. Instead, a posterior distribution representing the set of possible values for the BiV - RV difference in improvement in LVEF through 24 months was used|Bayesian Credible Interval||Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean LVEF change through 24 months.|The null hypothesis is that patients with AV block, ejection fractions of at most 50%, and NYHA classifications of I, II, or III who receive biventricular pacing have the same average change in LVEF from randomization to 24 months as corresponding patients who receive right ventricular pacing. This was tested against the hypothesis that patients with biventricular pacing have a different change in LVEF from randomization to 24 months than patients with right ventricular pacing.||5.604|1.623|
72394832|NCT00555321|144296254|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|||||TWO_SIDED|95.0|-16.9|15.3|||||For 95% CI of difference, normal approximation was used if N\>=5 in both arms. Otherwise exact method was used.|||15.3|-16.9|
72394833|NCT00555321|144296255|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|33.1|||||TWO_SIDED|95.0|15.8|50.6|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|||50.6|15.8|
72394834|NCT00555321|144296255|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|29.0|||||TWO_SIDED|95.0|11.4|46.3|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|||46.3|11.4|
72394835|NCT00555321|144296255|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|34.2|||||TWO_SIDED|95.0|16.9|51.5|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|||51.5|16.9|
72394836|NCT00555321|144296255|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.0|||||TWO_SIDED|95.0|-7.1|31.6|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|||31.6|-7.1|
72394837|NCT00555321|144296255|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.9|||||TWO_SIDED|95.0|-11.5|27.2|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|||27.2|-11.5|
72394838|NCT00555321|144296255|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.1|||||TWO_SIDED|95.0|-5.9|32.6|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|||32.6|-5.9|
72394839|NCT00555321|144296256|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|15.6|||||TWO_SIDED|95.0|-5.8|36.8|||||For 95% CI of difference, normal approximation was used if N\>=5 in both arms. Otherwise exact method was used.|||36.8|-5.8|
72394840|NCT00555321|144296256|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.0|||||TWO_SIDED|95.0|-6.0|38.0|||||For 95% CI of difference, normal approximation was used if N\>=5 in both arms. Otherwise exact method was used.|||38.0|-6.0|
72394841|NCT00555321|144296256|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.9|||||TWO_SIDED|95.0|-16.6|26.8|||||For 95% CI of difference, normal approximation was used if N\>=5 in both arms. Otherwise exact method was used.|||26.8|-16.6|
72394842|NCT00555321|144296256|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.6|||||TWO_SIDED|95.0|-10.8|36.1|||||For 95% CI of difference, normal approximation was used if N\>=5 in both arms. Otherwise exact method was used.|||36.1|-10.8|
72468912|NCT00267098|144461228|SUPERIORITY_OR_OTHER||Posterior BiV - RV Mean Difference|-7.204|||||TWO_SIDED|95.0|-10.12|-4.214||BLOCK HF is a Bayesian study; a p-value was not used since it is a non-Bayesian statistical tool. Instead,a posterior distribution representing the set of possible values for the BiV - RV difference in change in LVESVI through 6 months was used.|Bayesian Credible Interval||Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean LVESVI change through 6 months.|"The null hypothesis is that patients with AV block, ejection fractions of at most 50%, and NYHA classifications of I, II, or III who receive biventricular pacing have the same average change in LVESVI from randomization to 6 months as corresponding patients who receive right ventricular pacing.~This was tested against the hypothesis that patients with biventricular pacing have a different change in LVESVI from randomization to 6 months than patients with right ventricular pacing."||-4.214|-10.12|
72504280|NCT01025336|144539200|SUPERIORITY_OR_OTHER||geometric mean fold rise|1.2|||||TWO_SIDED|95.0|1.07|1.37|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 3: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||1.37|1.07|
72504281|NCT01025336|144539200|SUPERIORITY_OR_OTHER||geometric mean fold rise|2.1|||||TWO_SIDED|95.0|1.6|2.68|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 4: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||2.68|1.60|
72394843|NCT00555321|144296256|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.0|||||TWO_SIDED|95.0|-10.9|37.3|||||For 95% CI of difference, normal approximation was used if N\>=5 in both arms. Otherwise exact method was used.|||37.3|-10.9|
72394844|NCT00555321|144296256|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.9|||||TWO_SIDED|95.0|-21.8|26.0|||||For 95% CI of difference, normal approximation was used if N\>=5 in both arms. Otherwise exact method was used.|||26.0|-21.8|
72394845|NCT00555321|144296280|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|19.1|||||TWO_SIDED|95.0|-6.7|43.3|||||For 95% CI of difference, normal approximation was used if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 6||43.3|-6.7|
72394846|NCT00555321|144296280|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.7|||||TWO_SIDED|95.0|-21.6|25.5|||||For 95% CI of difference, normal approximation was used if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 6||25.5|-21.6|
72394847|NCT00555321|144296280|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.8|||||TWO_SIDED|95.0|-20.1|28.7|||||For 95% CI of difference, normal approximation was used if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 6||28.7|-20.1|
72394848|NCT00555321|144296280|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.8|||||TWO_SIDED|95.0|-21.2|32.1|||||For 95% CI of difference, normal approximation was used if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 6||32.1|-21.2|
72394849|NCT00555321|144296280|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.6|||||TWO_SIDED|95.0|-36.0|14.2|||||For 95% CI of difference, normal approximation was used if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 6||14.2|-36.0|
72394850|NCT00555321|144296280|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.5|||||TWO_SIDED|95.0|-34.6|17.3|||||For 95% CI of difference, normal approximation was used if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 6||17.3|-34.6|
72394851|NCT00555321|144296280|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.9|||||TWO_SIDED|95.0|-18.8|35.1|||||For 95% CI of difference, normal approximation was used if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 12||35.1|-18.8|
72622072|NCT04003142|144774322|SUPERIORITY||LSMean difference|-1.86|STANDARD_ERROR_OF_MEAN|0.53|<|0.001||95.0|-2.91|-0.81||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 11||-0.81|-2.91|<0.001
72394852|NCT00555321|144296280|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-21.6|||||TWO_SIDED|95.0|-46.3|6.3|||||For 95% CI of difference, normal approximation was used if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 12||6.3|-46.3|
72394853|NCT00555321|144296280|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-23.4|||||TWO_SIDED|95.0|-48.2|5.2|||||For 95% CI of difference, normal approximation was used if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 12||5.2|-48.2|
72394854|NCT00555321|144296280|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|23.4|||||TWO_SIDED|95.0|-5.2|48.4|||||For 95% CI of difference, normal approximation was used if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 12||48.4|-5.2|
72394855|NCT00555321|144296280|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.1|||||TWO_SIDED|95.0|-32.9|19.8|||||For 95% CI of difference, normal approximation was used if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 12||19.8|-32.9|
72394856|NCT00555321|144296280|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.9|||||TWO_SIDED|95.0|-34.8|18.7|||||For 95% CI of difference, normal approximation was used if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 12||18.7|-34.8|
72394857|NCT00555321|144296281|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.8|||||TWO_SIDED|95.0|-42.4|26.3|||||For 95% CI of difference, normal approximation was used if N \>= 5 in each treatment arm. Otherwise exact method was used.|Analysis at Month 12||26.3|-42.4|
72394858|NCT00555321|144296281|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.2|||||TWO_SIDED|95.0|-49.2|19.0|||||For 95% CI of difference, normal approximation was used if N \>= 5 in each treatment arm. Otherwise exact method was used.|Analysis at Month 12||19.0|-49.2|
72394859|NCT00555321|144296281|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-58.8|||||TWO_SIDED|95.0|-81.6|-19.8|||||For 95% CI of difference, normal approximation was used if N \>= 5 in each treatment arm. Otherwise exact method was used.|Analysis at Month 12||-19.8|-81.6|
72394860|NCT00555321|144296281|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-22.7|||||TWO_SIDED|95.0|-55.9|16.9|||||For 95% CI of difference, normal approximation was used if N \>= 5 in each treatment arm. Otherwise exact method was used.|Analysis at Month 12||16.9|-55.9|
72394861|NCT00555321|144296281|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-31.1|||||TWO_SIDED|95.0|-62.6|9.4|||||For 95% CI of difference, normal approximation was used if N \>= 5 in each treatment arm. Otherwise exact method was used.|Analysis at Month 12||9.4|-62.6|
72394862|NCT00555321|144296281|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-72.7|||||TWO_SIDED|95.0|-94.0|-33.1|||||For 95% CI of difference, normal approximation was used if N \>= 5 in each treatment arm. Otherwise exact method was used.|Analysis at Month 12||-33.1|-94.0|
72394863|NCT00555321|144296281|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.0|||||TWO_SIDED|95.0|-32.6|34.3|||||For 95% CI of difference, normal approximation was used if N \>= 5 in each treatment arm. Otherwise exact method was used.|Analysis at database lock||34.3|-32.6|
72394864|NCT00555321|144296281|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.7|||||TWO_SIDED|95.0|-47.4|20.6|||||For 95% CI of difference, normal approximation was used if N \>= 5 in each treatment arm. Otherwise exact method was used.|Analysis at database lock||20.6|-47.4|
72394865|NCT00555321|144296281|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-42.5|||||TWO_SIDED|95.0|-72.6|0.5|||||For 95% CI of difference, normal approximation was used if N \>= 5 in each treatment arm. Otherwise exact method was used.|Analysis at database lock||0.5|-72.6|
72394866|NCT00555321|144296281|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.1|||||TWO_SIDED|95.0|-41.1|31.1|||||For 95% CI of difference, normal approximation was used if N \>= 5 in each treatment arm. Otherwise exact method was used.|Analysis at database lock||31.1|-41.1|
72394867|NCT00555321|144296281|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-22.7|||||TWO_SIDED|95.0|-55.9|16.9|||||For 95% CI of difference, normal approximation was used if N \>= 5 in each treatment arm. Otherwise exact method was used.|Analysis at database lock||16.9|-55.9|
72622073|NCT04003142|144774322|SUPERIORITY||LSMean difference|-2.56|STANDARD_ERROR_OF_MEAN|0.53|<|0.001|TWO_SIDED|95.0|-3.61|-1.52||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 11||-1.52|-3.61|<0.001
72394868|NCT00555321|144296281|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-50.5|||||TWO_SIDED|95.0|-81.9|-3.5|||||For 95% CI of difference, normal approximation was used if N \>= 5 in each treatment arm. Otherwise exact method was used.|Analysis at database lock||-3.5|-81.9|
72394869|NCT00555321|144296294|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.9|||||TWO_SIDED|95.0|-21.2|6.0|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 6||6.0|-21.2|
72394870|NCT00555321|144296294|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.7|||||TWO_SIDED|95.0|-18.2|5.3|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 6||5.3|-18.2|
72394871|NCT00555321|144296294|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.3|||||TWO_SIDED|95.0|-14.9|4.5|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 6||4.5|-14.9|
72394872|NCT00555321|144296294|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.9|||||TWO_SIDED|95.0|-25.1|7.1|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 6||7.1|-25.1|
72394873|NCT00555321|144296294|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.7|||||TWO_SIDED|95.0|-15.6|4.5|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 6||4.5|-15.6|
72622074|NCT04003142|144774323|SUPERIORITY||LSMean difference|-0.13|STANDARD_ERROR_OF_MEAN|0.04||0.001||95.0|-0.21|-0.05||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 1||-0.05|-0.21|0.001
72468913|NCT00267098|144461229|SUPERIORITY_OR_OTHER||Posterior BiV - RV Mean Difference|-7.255|||||TWO_SIDED|95.0|-10.59|-3.829||BLOCK HF is a Bayesian study; a p-value was not used since it is a non-Bayesian statistical tool. Instead,a posterior distribution representing the set of possible values for the BiV - RV difference in change in LVESVI through 12 months was used.|Bayesian Credible Interval||Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean LVESVI change through 12 months.|The null hypothesis is that patients with AV block, ejection fractions of at most 50%, and NYHA classifications of I, II, or III who receive biventricular pacing have the same average change in LVESVI from randomization to 12 months as corresponding patients who receive right ventricular pacing. This was tested against the hypothesis that patients with biventricular pacing have a different change in LVESVI from randomization to 12 months than patients with right ventricular pacing.||-3.829|-10.590|
72468914|NCT00267098|144461230|SUPERIORITY_OR_OTHER||Posterior BiV - RV Mean Difference|-8.242|||||TWO_SIDED|95.0|-11.86|-4.574||BLOCK HF is a Bayesian study; a p-value was not used since it is a non-Bayesian statistical tool. Instead,a posterior distribution representing the set of possible values for the BiV - RV difference in change in LVESVI through 18 months was used.|Bayesian Credible Interval||Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean LVESVI change through 18 months.|The null hypothesis is that patients with AV block, ejection fractions of at most 50%, and NYHA classifications of I, II, or III who receive biventricular pacing have the same average change in LVESVI from randomization to 18 months as corresponding patients who receive right ventricular pacing. This was tested against the hypothesis that patients with biventricular pacing have a different change in LVESVI from randomization to 18 months than patients with right ventricular pacing.||-4.574|-11.860|
72468915|NCT00267098|144461231|SUPERIORITY_OR_OTHER||Posterior BiV - RV Mean Difference|-7.268|||||TWO_SIDED|95.0|-11.69|-2.846||BLOCK HF is a Bayesian study; a p-value was not used since it is a non-Bayesian statistical tool. Instead,a posterior distribution representing the set of possible values for the BiV - RV difference in change in LVESVI through 24 months was used.|Bayesian Credible Interval||Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean LVESVI change through 24 months.|The null hypothesis is that patients with AV block, ejection fractions of at most 50%, and NYHA classifications of I, II, or III who receive biventricular pacing have the same average change in LVESVI from randomization to 24 months as corresponding patients who receive right ventricular pacing. This was tested against the hypothesis that patients with biventricular pacing have a different change in LVESVI from randomization to 24 months than patients with right ventricular pacing.||-2.846|-11.690|
72468916|NCT00267098|144461232|SUPERIORITY_OR_OTHER||Posterior BiV - RV Mean Difference|-5.858|||||TWO_SIDED|95.0|-9.085|-2.562||BLOCK HF is a Bayesian study; a p-value was not used since it is a non-Bayesian statistical tool. Instead,a posterior distribution representing the set of possible values for the BiV - RV difference in change in LVEDVI through 6 months was used.|Bayesian Credible Interval||Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean LVEDVI change through 6 months.|The null hypothesis is that patients with AV block, ejection fractions of at most 50%, and NYHA classifications of I, II, or III who receive biventricular pacing have the same average change in LVEDVI from randomization to 6 months as corresponding patients who receive right ventricular pacing. This was tested against the hypothesis that patients with biventricular pacing have a different change in LVEDVI from randomization to 6 months than patients with right ventricular pacing.||-2.562|-9.085|
72468917|NCT00267098|144461233|SUPERIORITY_OR_OTHER||Posterior BiV - RV Mean Difference|-5.807|||||TWO_SIDED|95.0|-9.467|-2.038||BLOCK HF is a Bayesian study; a p-value was not used since it is a non-Bayesian statistical tool. Instead,a posterior distribution representing the set of possible values for the BiV - RV difference in change in LVEDVI through 12 months was used.|Bayesian Credible Interval||Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean LVEDVI change through 12 months.|"The null hypothesis is that patients with AV block, ejection fractions of at most 50%, and NYHA classifications of I, II, or III who receive biventricular pacing have the same average change in LVEDVI from randomization to 12 months as corresponding patients who receive right ventricular pacing.~This was tested against the hypothesis that patients with biventricular pacing have a different change in LVEDVI from randomization to 12 months than patients with right ventricular pacing."||-2.038|-9.467|
72504282|NCT01025336|144539200|SUPERIORITY_OR_OTHER||geometric mean fold rise|1.8|||||TWO_SIDED|95.0|1.55|2.03|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 5: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||2.03|1.55|
72622075|NCT04003142|144774323|SUPERIORITY||LSMean difference|-0.16|STANDARD_ERROR_OF_MEAN|0.04|<|0.001|TWO_SIDED|95.0|-0.24|-0.08||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 1||-0.08|-0.24|<0.001
72622076|NCT04003142|144774323|SUPERIORITY||LSMean difference|-0.17|STANDARD_ERROR_OF_MEAN|0.05||0.001||95.0|-0.28|-0.07||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 2||-0.07|-0.28|0.001
72468918|NCT00267098|144461234|SUPERIORITY_OR_OTHER||Posterior BiV - RV Mean Difference|-8.844|||||TWO_SIDED|95.0|-12.91|-4.681||BLOCK HF is a Bayesian study; a p-value was not used since it is a non-Bayesian statistical tool. Instead,a posterior distribution representing the set of possible values for the BiV - RV difference in change in LVEDVI through 18 months was used.|Bayesian Credible Interval||Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean LVEDVI change through 18 months.|"The null hypothesis is that patients with AV block, ejection fractions of at most 50%, and NYHA classifications of I, II, or III who receive biventricular pacing have the same average change in LVEDVI from randomization to 18 months as corresponding patients who receive right ventricular pacing.~This was tested against the hypothesis that patients with biventricular pacing have a different change in LVEDVI from randomization to 18 months than patients with right ventricular pacing."||-4.681|-12.910|
72468919|NCT00267098|144461235|SUPERIORITY_OR_OTHER||Posterior BiV - RV Mean Difference|-6.615|||||TWO_SIDED|95.0|-11.37|-1.736||BLOCK HF is a Bayesian study; a p-value was not used since it is a non-Bayesian statistical tool. Instead,a posterior distribution representing the set of possible values for the BiV - RV difference in change in LVEDVI through 24 months was used.|Bayesian Credible Interval||Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean LVEDVI change through 24 months.|The null hypothesis is that patients with AV block, ejection fractions of at most 50%, and NYHA classifications of I, II, or III who receive biventricular pacing have the same average change in LVEDVI from randomization to 24 months as corresponding patients who receive right ventricular pacing. This was tested against the hypothesis that patients with biventricular pacing have a different change in LVEDVI from randomization to 24 months than patients with right ventricular pacing.||-1.736|-11.370|
72468920|NCT00267098|144461236|SUPERIORITY_OR_OTHER||Posterior BiV - RV Mean Difference|-3.894|||||TWO_SIDED|95.0|-12.13|3.953||BLOCK HF is a Bayesian study; a p-value was not used since it is a non-Bayesian statistical tool. Instead,a posterior distribution representing the set of possible values for the BiV - RV difference in change in LV Mass through 6 months was used.|Bayesian Credible Interval||Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean LV Mass change through 6 months.|The null hypothesis is that patients with AV block, NYHA I-III, and LVEF of at most 50% who receive RV pacing have similar changes in LV Mass through 6 months compared to similar patients who receive BiV pacing. This was tested against the alternative hypothesis that patients have different changes in LV Mass through 6 months with BiV pacing than RV pacing. Change was calculated as 6 month value - randomization visit value.||3.953|-12.130|
72468921|NCT00267098|144461237|SUPERIORITY_OR_OTHER||Posterior BiV - RV Mean Difference|-10.16|||||TWO_SIDED|95.0|-19.33|-0.857||BLOCK HF is a Bayesian study; a p-value was not used since it is a non-Bayesian statistical tool. Instead,a posterior distribution representing the set of possible values for the BiV - RV difference in change in LV Mass through 12 months was used.|Bayesian Credible Interval||Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean LV Mass change through 12 months.|The null hypothesis is that patients with AV block, NYHA I-III, and LVEF of at most 50% who receive RV pacing have similar changes in LV Mass through 12 months compared to similar patients who receive BiV pacing. This was tested against the alternative hypothesis that patients have different changes in LV Mass through 12 months with BiV pacing than RV pacing. Change was calculated as 12 month value - randomization visit value.||-0.857|-19.330|
72468922|NCT00267098|144461238|SUPERIORITY_OR_OTHER||Posterior BiV - RV Mean Difference|-8.316|||||TWO_SIDED|95.0|-18.19|1.623||BLOCK HF is a Bayesian study; a p-value was not used since it is a non-Bayesian statistical tool. Instead,a posterior distribution representing the set of possible values for the BiV - RV difference in change in LV Mass through 18 months was used.|Bayesian Credible Interval||Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean LV Mass change through 18 months.|The null hypothesis is that patients with AV block, NYHA I-III, and LVEF of at most 50% who receive RV pacing have similar changes in LV Mass through 18 months compared to similar patients who receive BiV pacing. This was tested against the alternative hypothesis that patients have different changes in LV Mass through 18 months with BiV pacing than RV pacing. Change was calculated as 18 month value - randomization visit value.||1.623|-18.190|
72504283|NCT01025336|144539200|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.9|||||TWO_SIDED|95.0|0.79|1.07|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 6A: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||1.07|0.79|
72504284|NCT01025336|144539200|SUPERIORITY_OR_OTHER||geometric mean fold rise|1.3|||||TWO_SIDED|95.0|1.05|1.53|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 6B: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||1.53|1.05|
72504285|NCT01025336|144539200|SUPERIORITY_OR_OTHER||geometric mean fold rise|2.6|||||TWO_SIDED|95.0|1.98|3.5|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 7F: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||3.50|1.98|
72504286|NCT01025336|144539200|SUPERIORITY_OR_OTHER||geometric mean fold rise|1.9|||||TWO_SIDED|95.0|1.37|2.61|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 9V: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||2.61|1.37|
72622077|NCT04003142|144774323|SUPERIORITY||LSMean difference|-0.18|STANDARD_ERROR_OF_MEAN|0.05||0.001|TWO_SIDED|95.0|-0.28|-0.07||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 2||-0.07|-0.28|0.001
72394874|NCT00555321|144296294|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.3|||||TWO_SIDED|95.0|-12.7|3.9|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 6||3.9|-12.7|
72394875|NCT00555321|144296294|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||||95.0|||||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 12||||
72394876|NCT00555321|144296294|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.7|||||TWO_SIDED|95.0|-18.2|5.3|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 12||5.3|-18.2|
72394877|NCT00555321|144296294|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.3|||||TWO_SIDED|95.0|-14.9|4.5|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 12||4.5|-14.9|
72394878|NCT00555321|144296294|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||||95.0|||||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 12||||
72468923|NCT00267098|144461239|SUPERIORITY_OR_OTHER||Posterior BiV - RV Mean Difference|-11.08|||||TWO_SIDED|95.0|-21.11|-0.956||BLOCK HF is a Bayesian study; a p-value was not used since it is a non-Bayesian statistical tool. Instead,a posterior distribution representing the set of possible values for the BiV - RV difference in change in LV Mass through 24 months was used.|Bayesian Credible Interval||Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean LV Mass change through 24 months.|The null hypothesis is that patients with AV block, NYHA I-III, and LVEF of at most 50% who receive RV pacing have similar changes in LV Mass through 24 months compared to similar patients who receive BiV pacing. This was tested against the alternative hypothesis that patients have different changes in LV Mass through 24 months with BiV pacing than RV pacing. Change was calculated as 24 month value - randomization visit value.||-0.956|-21.110|
72468924|NCT00267098|144461240|SUPERIORITY_OR_OTHER||Posterior BiV - RV Mean Difference|-0.126|||||TWO_SIDED|95.0|-0.235|-0.014||BLOCK HF is a Bayesian study; a p-value was not used since it is a non-Bayesian statistical tool. Instead,a posterior distribution representing the set of possible values for the BiV - RV difference in change in LVEDD through 6 months was used.|Bayesian Credible Interval||Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean LVEDD change through 6 months.|The null hypothesis is that patients with AV block, ejection fractions of at most 50%, and NYHA classifications of I, II, or III who receive biventricular pacing have the same average change in LVEDD from randomization to 6 months as similar patients who receive right ventricular pacing. This was tested against the hypothesis that patients with BiV pacing have a different change in LVEDD from randomization to 6 months than patients with RV pacing. Negative values reflect reductions in LVEDD.||-0.014|-0.235|
72469787|NCT01575873|144463469|NON_INFERIORITY|Non-inferiority was shown if the lower bound of the two-sided 95% CI for the difference between the least-squares means (denosumab minus risedronate) was higher than the prespecified non-inferiority margin of -1.1 percentage points for the glucocorticoid-initiating subpopulation.|LS Mean Difference|2.9|||<|0.001|TWO_SIDED|95.0|2.0|3.9||One-sided p-value based on the prespecified noninferiority margin for lumbar spine of -1.1%.|ANCOVA||Least Squares (LS) Mean Difference = Denosumab - Risedronate|"Analyses of the primary and secondary endpoints were performed independently within the glucocorticoid-continuing and glucocorticoid-initiating subpopulations. A fixed-sequence testing procedure was used to control the experiment-wise type 1 error rate at a two-sided 5% significance level within each subpopulation.~The glucocorticoid-initiating subpopulation was analyzed using an ANCOVA model adjusting for treatment, baseline BMD, sex, machine type, and baseline BMD-by-machine type interaction."||3.9|2.0|< 0.001
72504287|NCT01025336|144539200|SUPERIORITY_OR_OTHER||geometric mean fold rise|1.6|||||TWO_SIDED|95.0|1.33|1.86|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 14: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||1.86|1.33|
72504288|NCT01025336|144539200|SUPERIORITY_OR_OTHER||geometric mean fold rise|1.3|||||TWO_SIDED|95.0|1.1|1.42|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 18C: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||1.42|1.10|
72504289|NCT01025336|144539200|SUPERIORITY_OR_OTHER||geometric mean fold rise|1.3|||||TWO_SIDED|95.0|1.14|1.43|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 19A: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||1.43|1.14|
72504290|NCT01025336|144539200|SUPERIORITY_OR_OTHER||geometric mean fold rise|2.2|||||TWO_SIDED|95.0|1.8|2.6|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 19F: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||2.60|1.80|
72394879|NCT00555321|144296294|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.7|||||TWO_SIDED|95.0|-15.6|4.5|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 12||4.5|-15.6|
72394880|NCT00555321|144296294|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.3|||||TWO_SIDED|95.0|-12.7|3.9|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 12||3.9|-12.7|
72394881|NCT00555321|144296295|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.7|||||TWO_SIDED|95.0|-25.6|10.2|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 6||10.2|-25.6|
72468925|NCT00267098|144461241|SUPERIORITY_OR_OTHER||Posterior BiV - RV Mean Difference|-0.162|||||TWO_SIDED|95.0|-0.287|-0.035||BLOCK HF is a Bayesian study; a p-value was not used since it is a non-Bayesian statistical tool. Instead,a posterior distribution representing the set of possible values for the BiV - RV difference in change in LVEDD through 12 months was used.|Bayesian Credible Interval||Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean LVEDD change through 12 months.|The null hypothesis is that patients with AV block, ejection fractions of at most 50%, and NYHA classifications of I, II, or III who receive biventricular pacing have the same average change in LVEDD from randomization to 12 months as similar patients who receive right ventricular pacing. This was tested against the hypothesis that patients with BiV pacing have a different change in LVEDD from randomization to 12 months than patients with RV pacing. Negative values reflect reductions in LVEDD.||-0.035|-0.287|
72468926|NCT00267098|144461242|SUPERIORITY_OR_OTHER||Posterior BiV - RV Mean Difference|-0.163|||||TWO_SIDED|95.0|-0.293|-0.03||BLOCK HF is a Bayesian study; a p-value was not used since it is a non-Bayesian statistical tool. Instead,a posterior distribution representing the set of possible values for the BiV - RV difference in change in LVEDD through 18 months was used.|Bayesian Credible Interval||Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean LVEDD change through 18 months.|The null hypothesis is that patients with AV block, ejection fractions of at most 50%, and NYHA classifications of I, II, or III who receive biventricular pacing have the same average change in LVEDD from randomization to 18 months as similar patients who receive right ventricular pacing. This was tested against the hypothesis that patients with BiV pacing have a different change in LVEDD from randomization to 18 months than patients with RV pacing. Negative values reflect reductions in LVEDD.||-0.030|-0.293|
72468927|NCT00267098|144461243|SUPERIORITY_OR_OTHER||Posterior BiV - RV Mean Difference|-0.245|||||TWO_SIDED|95.0|-0.39|-0.097||BLOCK HF is a Bayesian study; a p-value was not used since it is a non-Bayesian statistical tool. Instead,a posterior distribution representing the set of possible values for the BiV - RV difference in change in LVEDD through 24 months was used.|Bayesian Credible Interval||Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean LVEDD change through 24 months.|The null hypothesis is that patients with AV block, ejection fractions of at most 50%, and NYHA classifications of I, II, or III who receive biventricular pacing have the same average change in LVEDD from randomization to 24 months as similar patients who receive right ventricular pacing. This was tested against the hypothesis that patients with BiV pacing have a different change in LVEDD from randomization to 24 months than patients with RV pacing. Negative values reflect reductions in LVEDD.||-0.097|-0.390|
72504291|NCT01025336|144539200|SUPERIORITY_OR_OTHER||geometric mean fold rise|1.7|||||TWO_SIDED|95.0|1.44|2.06|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 23F: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||2.06|1.44|
72504292|NCT01025336|144539201|SUPERIORITY_OR_OTHER||Ratio|1.2|||||TWO_SIDED|95.0|0.87|1.64|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the measures \[(13vPnC - 23vPS)\].|Serotype 1: Ratio of GMT (13vPnC to 23vPS) was calculated by back transforming the mean difference between vaccine group on the logarithmic scale.||1.64|0.87|
72504293|NCT01025336|144539201|SUPERIORITY_OR_OTHER||Ratio|0.8|||||TWO_SIDED|95.0|0.63|1.08|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the measures \[(13vPnC - 23vPS)\].|Serotype 3: Ratio of GMT (13vPnC to 23vPS) was calculated by back transforming the mean difference between vaccine group on the logarithmic scale.||1.08|0.63|
72622078|NCT04003142|144774323|SUPERIORITY||LSMean difference|-0.11|STANDARD_ERROR_OF_MEAN|0.06||0.067||95.0|-0.23|0.01||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 3||0.01|-0.23|0.067
72394882|NCT00555321|144296295|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.4|||||TWO_SIDED|95.0|-11.7|22.3|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 6||22.3|-11.7|
72504294|NCT01025336|144539201|SUPERIORITY_OR_OTHER||Ratio|1.9|||||TWO_SIDED|95.0|1.25|2.8|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the measures \[(13vPnC - 23vPS)\].|Serotype 4: Ratio of GMT (13vPnC to 23vPS) was calculated by back transforming the mean difference between vaccine group on the logarithmic scale.||2.80|1.25|
72504295|NCT01025336|144539201|SUPERIORITY_OR_OTHER||Ratio|1.0|||||TWO_SIDED|95.0|0.71|1.53|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the measures \[(13vPnC - 23vPS)\].|Serotype 5: Ratio of GMT (13vPnC to 23vPS) was calculated by back transforming the mean difference between vaccine group on the logarithmic scale.||1.53|0.71|
72504296|NCT01025336|144539201|SUPERIORITY_OR_OTHER||Ratio|7.3|||||TWO_SIDED|95.0|4.67|11.44|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the measures \[(13vPnC - 23vPS)\].|Serotype 6A: Ratio of GMT (13vPnC to 23vPS) was calculated by back transforming the mean difference between vaccine group on the logarithmic scale.||11.44|4.67|
72504297|NCT01025336|144539201|SUPERIORITY_OR_OTHER||Ratio|2.6|||||TWO_SIDED|95.0|1.61|4.17|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the measures \[(13vPnC - 23vPS)\].|Serotype 6B: Ratio of GMT (13vPnC to 23vPS) was calculated by back transforming the mean difference between vaccine group on the logarithmic scale.||4.17|1.61|
72468928|NCT00267098|144461244|SUPERIORITY_OR_OTHER||Posterior BiV - RV Mean Difference|-0.066|||||TWO_SIDED|95.0|-0.185|0.055||BLOCK HF is a Bayesian study; a p-value was not used since it is a non-Bayesian statistical tool. Instead,a posterior distribution representing the set of possible values for the BiV - RV difference in change in LVESD through 6 months was used.|Bayesian Credible Interval||Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean LVESD change through 6 months.|The null hypothesis is that patients with AV block, ejection fractions of at most 50%, and NYHA classifications of I, II, or III who receive biventricular pacing have the same average change in LVESD from randomization to 6 months as similar patients who receive right ventricular pacing. This was tested against the hypothesis that patients with BiV pacing have a different change in LVESD from randomization to 6 months than patients with RV pacing. Negative values reflect reductions in LVESD.||0.055|-0.185|
72468929|NCT00267098|144461245|SUPERIORITY_OR_OTHER||Posterior BiV - RV Mean Difference|-0.104|||||TWO_SIDED|95.0|-0.236|0.029||BLOCK HF is a Bayesian study; a p-value was not used since it is a non-Bayesian statistical tool. Instead,a posterior distribution representing the set of possible values for the BiV - RV difference in change in LVESD through 12 months was used.|Bayesian Credible Interval||Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean LVESD change through 12 months.|The null hypothesis is that patients with AV block, ejection fractions of at most 50%, and NYHA classifications of I, II, or III who receive biventricular pacing have the same average change in LVESD from randomization to 12 months as similar patients who receive right ventricular pacing. This was tested against the hypothesis that patients with BiV pacing have a different change in LVESD from randomization to 12 months than patients with RV pacing. Negative values reflect reductions in LVESD.||0.029|-0.236|
72468930|NCT00267098|144461246|SUPERIORITY_OR_OTHER||Posterior BiV - RV Mean Difference|-0.06|||||TWO_SIDED|95.0|-0.204|0.087||BLOCK HF is a Bayesian study; a p-value was not used since it is a non-Bayesian statistical tool. Instead,a posterior distribution representing the set of possible values for the BiV - RV difference in change in LVESD through 18 months was used.|Bayesian Credible Interval||Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean LVESD change through 18 months.|The null hypothesis is that patients with AV block, ejection fractions of at most 50%, and NYHA classifications of I, II, or III who receive biventricular pacing have the same average change in LVESD from randomization to 18 months as similar patients who receive right ventricular pacing. This was tested against the hypothesis that patients with BiV pacing have a different change in LVESD from randomization to 18 months than patients with RV pacing. Negative values reflect reductions in LVESD.||0.087|-0.204|
72468931|NCT00267098|144461247|SUPERIORITY_OR_OTHER||Posterior BiV - RV Mean Difference|-0.18|||||TWO_SIDED|95.0|-0.339|-0.018||BLOCK HF is a Bayesian study; a p-value was not used since it is a non-Bayesian statistical tool. Instead,a posterior distribution representing the set of possible values for the BiV - RV difference in change in LVESD through 24 months was used.|Bayesian Credible Interval||Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean LVESD change through 24 months.|The null hypothesis is that patients with AV block, ejection fractions of at most 50%, and NYHA classifications of I, II, or III who receive biventricular pacing have the same average change in LVESD from randomization to 24 months as similar patients who receive right ventricular pacing. This was tested against the hypothesis that patients with BiV pacing have a different change in LVESD from randomization to 24 months than patients with RV pacing. Negative values reflect reductions in LVESD.||-0.018|-0.339|
72468932|NCT00267098|144461248|SUPERIORITY_OR_OTHER||Posterior BiV - RV Mean Difference|-0.683|||||TWO_SIDED|95.0|-2.828|1.506||BLOCK HF is a Bayesian study; a p-value was not used since it is a non-Bayesian statistical tool. Instead,a posterior distribution representing the set of possible values for the BiV - RV difference in change in MR through 6 months was used.|Bayesian Credible Interval||Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean MR change through 6 months.|The null hypothesis is that patients with AV block, NYHA I-III, and LVEF of at most 50% who receive RV pacing have similar changes in Mitral Regurgitation (MR) through 6 months compared to similar patients who receive BiV pacing. This was tested against the alternative hypothesis that patients have different changes in Mitral Regurgitation through 6 months with BiV pacing than RV pacing. Change was calculated as 6 month value - randomization visit value.||1.506|-2.828|
72468933|NCT00267098|144461249|SUPERIORITY_OR_OTHER||Posterior BiV - RV Mean Difference|-0.564|||||TWO_SIDED|95.0|-2.843|1.773||BLOCK HF is a Bayesian study; a p-value was not used since it is a non-Bayesian statistical tool. Instead,a posterior distribution representing the set of possible values for the BiV - RV difference in change in MR through 12 months was used.|Bayesian Credible Interval||Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean MR change through 12 months.|The null hypothesis is that patients with AV block, NYHA I-III, and LVEF of at most 50% who receive RV pacing have similar changes in Mitral Regurgitation (MR) through 12 months compared to similar patients who receive BiV pacing. This was tested against the alternative hypothesis that patients have different changes in Mitral Regurgitation through 12 months with BiV pacing than RV pacing. Change was calculated as 12 month value - randomization visit value.||1.773|-2.843|
72565137|NCT00107042|144661887|SUPERIORITY_OR_OTHER||Regression coeffcient|0.2053|STANDARD_ERROR_OF_MEAN|0.1885||0.2796||95.0|||||Regression, Linear|||This is a regression analysis for testing the effect of age(15 - 17 year old particpants vs. 12 - 14 year old participants) on vaccine response as measured in log10 titers. The null hypothesis is no difference between groups.||||0.2796
72565138|NCT00107042|144661887|SUPERIORITY_OR_OTHER||Regresssion coeffcient|-0.4726|STANDARD_ERROR_OF_MEAN|0.1734||0.008||95.0|||||Regression, Linear|||This is a regression analysis for testing the effect of gender(Females vs. Males) on vaccine response as measured in log10 titers. The null hypothesis is no difference between groups.||||0.0080
72565139|NCT00107042|144661887|SUPERIORITY_OR_OTHER||Regression coefficient|0.2189|STANDARD_ERROR_OF_MEAN|0.1905||0.2543||95.0|||||Regression, Linear|||This is a regression analysis for testing the effect of Hispanic ethnicity (Not Hispanic vs. Hispanic) on vaccine response as measured in log10 titers. The null hypothesis is no difference between groups.||||0.2543
72565140|NCT00107042|144661887|SUPERIORITY_OR_OTHER||Regression coefficient|0.2994|STANDARD_ERROR_OF_MEAN|0.3292||0.3661||95.0|||||Regression, Linear|||This is a regression analysis for testing the effect of racial background(White vs. Other/Mixed vs. Black/African American) on vaccine response as measured in log10 titers. The null hypothesis is no difference between groups. In this statistical analysis, information for the comparison between White vs. Other/Mixed Race is presented.||||0.3661
72565141|NCT00107042|144661887|SUPERIORITY_OR_OTHER||Regression coefficient|0.0083|STANDARD_ERROR_OF_MEAN|0.3497||0.9812||95.0|||||Regression, Linear|||This is a regression analysis for testing the effect of racial background(White vs. Other/Mixed vs. Black/African American) on vaccine response as measured in log10 titers. The null hypothesis is no difference between groups. In this statistical analysis, information for the comparison between White vs. Black/African American is presented.||||0.9812
72468934|NCT00267098|144461250|SUPERIORITY_OR_OTHER||Posterior BiV - RV Mean Difference|0.016|||||TWO_SIDED|95.0|-2.379|2.425||BLOCK HF is a Bayesian study; a p-value was not used since it is a non-Bayesian statistical tool. Instead,a posterior distribution representing the set of possible values for the BiV - RV difference in change in MR through 18 months was used.|Bayesian Credible Interval||Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean MR change through 18 months.|The null hypothesis is that patients with AV block, NYHA I-III, and LVEF of at most 50% who receive RV pacing have similar changes in Mitral Regurgitation (MR) through 18 months compared to similar patients who receive BiV pacing. This was tested against the alternative hypothesis that patients have different changes in Mitral Regurgitation through 18 months with BiV pacing than RV pacing. Change was calculated as 18 month value - randomization visit value.||2.425|-2.379|
72468935|NCT00267098|144461251|SUPERIORITY_OR_OTHER||Posterior BiV - RV Mean Difference|-0.653|||||TWO_SIDED|95.0|-3.337|2.046||BLOCK HF is a Bayesian study; a p-value was not used since it is a non-Bayesian statistical tool. Instead,a posterior distribution representing the set of possible values for the BiV - RV difference in change in MR through 24 months was used.|Bayesian Credible Interval||Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean MR change through 24 months.|The null hypothesis is that patients with AV block, NYHA I-III, and LVEF of at most 50% who receive RV pacing have similar changes in Mitral Regurgitation (MR) through 24 months compared to similar patients who receive BiV pacing. This was tested against the alternative hypothesis that patients have different changes in Mitral Regurgitation through 24 months with BiV pacing than RV pacing. Change was calculated as 24 month value - randomization visit value.||2.046|-3.337|
72468936|NCT00267098|144461252|SUPERIORITY_OR_OTHER||Posterior BiV - RV Mean Difference|0.08|||||TWO_SIDED|95.0|-0.031|0.195||BLOCK HF is a Bayesian study; a p-value was not used since it is a non-Bayesian statistical tool. Instead,a posterior distribution representing the set of possible values for the BiV - RV difference in change in CI through 6 months was used.|Bayesian Credible Interval||Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean CI change through 6 months.|The null hypothesis is that patients with AV block, NYHA I-III, and LVEF of at most 50% who receive RV pacing have similar changes in Cardiac Index (CI) through 6 months compared to similar patients who receive BiV pacing. This was tested against the alternative hypothesis that patients have different changes in Cardiac Index through 6 months with BiV pacing than RV pacing. Change was calculated as 6 month value - randomization visit value.||0.195|-0.031|
72504298|NCT01025336|144539201|SUPERIORITY_OR_OTHER||Ratio|2.0|||||TWO_SIDED|95.0|1.22|3.29|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the measures \[(13vPnC - 23vPS)\].|Serotype 7F: Ratio of GMT (13vPnC to 23vPS) was calculated by back transforming the mean difference between vaccine group on the logarithmic scale.||3.29|1.22|
72504299|NCT01025336|144539201|SUPERIORITY_OR_OTHER||Ratio|1.6|||||TWO_SIDED|95.0|0.96|2.77|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the measures \[(13vPnC - 23vPS)\].|Serotype 9V: Ratio of GMT (13vPnC to 23vPS) was calculated by back transforming the mean difference between vaccine group on the logarithmic scale.||2.77|0.96|
72565142|NCT00107042|144661887|SUPERIORITY_OR_OTHER||Regression coefficient|-0.0663|STANDARD_ERROR_OF_MEAN|0.2314||0.7766||95.0|||||Regression, Linear|||This is a regression analysis for testing the effect of Tanner Stage for Females(Stage 5 vs. Stages 1 - 4) on vaccine response as measured in log10 titers. The null hypothesis is no difference between groups.||||0.7766
72565143|NCT00107042|144661887|SUPERIORITY_OR_OTHER||Regression coefficient|-0.2929|STANDARD_ERROR_OF_MEAN|0.2508||0.2492||95.0|||||Regression, Linear|||This is a regression analysis for testing the effect of Tanner Stage for Males(Stage 5 vs. Stages 1 - 4) on vaccine response as measured in log10 titers. The null hypothesis is no difference between groups.||||0.2492
72565144|NCT00107042|144661887|SUPERIORITY_OR_OTHER||Regression coeffcient|-0.316|STANDARD_ERROR_OF_MEAN|0.1826||0.0877||95.0|||||Regression, Linear|||This is a regression analysis for testing the effect of BMI at Baseline(Normal and Underweight (\<25.0) vs. Overweight and Obsese (\>= 25.0)) on vaccine response as measured in log10 titers. The null hypothesis is no difference between groups.||||0.0877
72622079|NCT04003142|144774323|SUPERIORITY||LSMean difference|-0.23|STANDARD_ERROR_OF_MEAN|0.06|<|0.001|TWO_SIDED|95.0|-0.35|-0.11||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 3||-0.11|-0.35|<0.001
72565145|NCT00107042|144661887|SUPERIORITY_OR_OTHER||Regression coefficient|-0.0292|STANDARD_ERROR_OF_MEAN|0.0113||0.0117||95.0|||||Regression, Linear|||This is a regression analysis for testing the effect of BMI at Baseline(continuous variable) on vaccine response as measured in log10 titers.||||0.0117
72565146|NCT00107042|144661887|SUPERIORITY_OR_OTHER||Regression coefficient|-0.0578|STANDARD_ERROR_OF_MEAN|0.2163||0.7899||95.0|||||Regression, Linear|||This is a regression analysis for testing the effect of smokng cigarettes(Never Smoked vs. Has Smoked) on vaccine response as measured in log10 titers. The null hypothesis is no difference between groups.||||0.7899
72504300|NCT01025336|144539201|SUPERIORITY_OR_OTHER||Ratio|0.8|||||TWO_SIDED|95.0|0.54|1.28|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the measures \[(13vPnC - 23vPS)\].|Serotype 14: Ratio of GMT (13vPnC to 23vPS) was calculated by back transforming the mean difference between vaccine group on the logarithmic scale.||1.28|0.54|
72504301|NCT01025336|144539201|SUPERIORITY_OR_OTHER||Ratio|1.4|||||TWO_SIDED|95.0|0.92|2.07|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the measures \[(13vPnC - 23vPS)\].|Serotype 18C: Ratio of GMT (13vPnC to 23vPS) was calculated by back transforming the mean difference between vaccine group on the logarithmic scale.||2.07|0.92|
72504302|NCT01025336|144539201|SUPERIORITY_OR_OTHER||Ratio|1.4|||||TWO_SIDED|95.0|1.01|1.83|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the measures \[(13vPnC - 23vPS)\].|Serotype 19A: Ratio of GMT (13vPnC to 23vPS) was calculated by back transforming the mean difference between vaccine group on the logarithmic scale.||1.83|1.01|
72504303|NCT01025336|144539201|SUPERIORITY_OR_OTHER||Ratio|1.2|||||TWO_SIDED|95.0|0.77|1.78|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the measures \[(13vPnC - 23vPS)\].|Serotype 19F: Ratio of GMT (13vPnC to 23vPS) was calculated by back transforming the mean difference between vaccine group on the logarithmic scale.||1.78|0.77|
72504304|NCT01025336|144539201|SUPERIORITY_OR_OTHER||Ratio|3.0|||||TWO_SIDED|95.0|1.97|4.64|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the measures \[(13vPnC - 23vPS)\].|Serotype 23F: Ratio of GMT (13vPnC to 23vPS) was calculated by back transforming the mean difference between vaccine group on the logarithmic scale.||4.64|1.97|
72504305|NCT01025336|144539202|SUPERIORITY_OR_OTHER||Ratio|1.6|||||TWO_SIDED|95.0|1.15|2.15|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the measures \[(13vPnC - 23vPS)\].|Serotype 1: Ratio of GMT (13vPnC to 23vPS) was calculated by back transforming the mean difference between vaccine group on the logarithmic scale||2.15|1.15|
72504306|NCT01025336|144539202|SUPERIORITY_OR_OTHER||Ratio|1.0|||||TWO_SIDED|95.0|0.76|1.32|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the measures \[(13vPnC - 23vPS)\].|Serotype 3: Ratio of GMT (13vPnC to 23vPS) was calculated by back transforming the mean difference between vaccine group on the logarithmic scale||1.32|0.76|
72504307|NCT01025336|144539202|SUPERIORITY_OR_OTHER||Ratio|1.8|||||TWO_SIDED|95.0|1.09|3.05|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the measures \[(13vPnC - 23vPS)\].|Serotype 4: Ratio of GMT (13vPnC to 23vPS) was calculated by back transforming the mean difference between vaccine group on the logarithmic scale||3.05|1.09|
72504308|NCT01025336|144539202|SUPERIORITY_OR_OTHER||Ratio|1.4|||||TWO_SIDED|95.0|0.95|1.96|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the measures \[(13vPnC - 23vPS)\].|Serotype 5: Ratio of GMT (13vPnC to 23vPS) was calculated by back transforming the mean difference between vaccine group on the logarithmic scale||1.96|0.95|
72504309|NCT01025336|144539202|SUPERIORITY_OR_OTHER||Ratio|4.8|||||TWO_SIDED|95.0|3.05|7.5|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the measures \[(13vPnC - 23vPS)\].|Serotype 6A: Ratio of GMT (13vPnC to 23vPS) was calculated by back transforming the mean difference between vaccine group on the logarithmic scale||7.50|3.05|
72504310|NCT01025336|144539202|SUPERIORITY_OR_OTHER||Ratio|2.3|||||TWO_SIDED|95.0|1.4|3.64|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the measures \[(13vPnC - 23vPS)\].|Serotype 6B: Ratio of GMT (13vPnC to 23vPS) was calculated by back transforming the mean difference between vaccine group on the logarithmic scale||3.64|1.40|
72504311|NCT01025336|144539202|SUPERIORITY_OR_OTHER||Ratio|1.0|||||TWO_SIDED|95.0|0.58|1.62|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the measures \[(13vPnC - 23vPS)\].|Serotype 7F: Ratio of GMT (13vPnC to 23vPS) was calculated by back transforming the mean difference between vaccine group on the logarithmic scale||1.62|0.58|
72622080|NCT04003142|144774323|SUPERIORITY||LSMean difference|-0.16|STANDARD_ERROR_OF_MEAN|0.07||0.02|TWO_SIDED|95.0|-0.3|-0.03||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 5||-0.03|-0.30|0.020
72504312|NCT01025336|144539202|SUPERIORITY_OR_OTHER||Ratio|1.4|||||TWO_SIDED|95.0|0.83|2.32|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the measures \[(13vPnC - 23vPS)\].|Serotype 9V: Ratio of GMT (13vPnC to 23vPS) was calculated by back transforming the mean difference between vaccine group on the logarithmic scale||2.32|0.83|
72504313|NCT01025336|144539202|SUPERIORITY_OR_OTHER||Ratio|0.9|||||TWO_SIDED|95.0|0.58|1.4|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the measures \[(13vPnC - 23vPS)\].|Serotype 14: Ratio of GMT (13vPnC to 23vPS) was calculated by back transforming the mean difference between vaccine group on the logarithmic scale||1.40|0.58|
72504314|NCT01025336|144539202|SUPERIORITY_OR_OTHER||Ratio|1.6|||||TWO_SIDED|95.0|1.09|2.41|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the measures \[(13vPnC - 23vPS)\].|Serotype 18C: Ratio of GMT (13vPnC to 23vPS) was calculated by back transforming the mean difference between vaccine group on the logarithmic scale||2.41|1.09|
72504315|NCT01025336|144539202|SUPERIORITY_OR_OTHER||Ratio|1.5|||||TWO_SIDED|95.0|1.1|2.03|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the measures \[(13vPnC - 23vPS)\].|Serotype 19A: Ratio of GMT (13vPnC to 23vPS) was calculated by back transforming the mean difference between vaccine group on the logarithmic scale||2.03|1.10|
72622081|NCT04003142|144774323|SUPERIORITY||LSMean difference|-0.29|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|95.0|-0.43|-0.16||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 5||-0.16|-0.43|<0.001
72468937|NCT00267098|144461253|SUPERIORITY_OR_OTHER||Posterior BiV - RV Mean Difference|0.086|||||TWO_SIDED|95.0|-0.022|0.198||BLOCK HF is a Bayesian study; a p-value was not used since it is a non-Bayesian statistical tool. Instead,a posterior distribution representing the set of possible values for the BiV - RV difference in change in CI through 12 months was used.|Bayesian Credible Interval||Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean CI change through 12 months.|The null hypothesis is that patients with AV block, NYHA I-III, and LVEF of at most 50% who receive RV pacing have similar changes in Cardiac Index (CI) through 12 months compared to similar patients who receive BiV pacing. This was tested against the alternative hypothesis that patients have different changes in Cardiac Index through 12 months with BiV pacing than RV pacing. Change was calculated as 12 month value - randomization visit value.||0.198|-0.022|
72468938|NCT00267098|144461254|SUPERIORITY_OR_OTHER||Posterior BiV - RV Mean Difference|-0.081|||||TWO_SIDED|95.0|-0.218|0.058||BLOCK HF is a Bayesian study; a p-value was not used since it is a non-Bayesian statistical tool. Instead,a posterior distribution representing the set of possible values for the BiV - RV difference in change in CI through 18 months was used.|Bayesian Credible Interval||Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean CI change through 18 months.|The null hypothesis is that patients with AV block, NYHA I-III, and LVEF of at most 50% who receive RV pacing have similar changes in Cardiac Index (CI) through 18 months compared to similar patients who receive BiV pacing. This was tested against the alternative hypothesis that patients have different changes in Cardiac Index through 18 months with BiV pacing than RV pacing. Change was calculated as 18 month value - randomization visit value.||0.058|-0.218|
72468939|NCT00267098|144461255|SUPERIORITY_OR_OTHER||Posterior BiV - RV Mean Difference|0.047|||||TWO_SIDED|95.0|-0.095|0.192||BLOCK HF is a Bayesian study; a p-value was not used since it is a non-Bayesian statistical tool. Instead,a posterior distribution representing the set of possible values for the BiV - RV difference in change in CI through 24 months was used.|Bayesian Credible Interval||Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean CI change through 24 months.|The null hypothesis is that patients with AV block, NYHA I-III, and LVEF of at most 50% who receive RV pacing have similar changes in Cardiac Index (CI) through 24 months compared to similar patients who receive BiV pacing. This was tested against the alternative hypothesis that patients have different changes in Cardiac Index through 24 months with BiV pacing than RV pacing. Change was calculated as 24 month value - randomization visit value.||0.192|-0.095|
72468940|NCT00267098|144461256|SUPERIORITY_OR_OTHER||Posterior BiV - RV Mean Difference|29.3|||||TWO_SIDED|95.0|10.04|48.64||BLOCK HF is a Bayesian study; a p-value was not used since it is a non-Bayesian statistical tool. Instead,a posterior distribution representing the set of possible values for the BiV - RV difference in change in IVMD through 6 months was used.|Bayesian Credible Interval||Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean IVMD change through 6 months.|The null hypothesis is that patients with AV block, NYHA I-III, and LVEF of at most 50% who receive RV pacing have similar changes in IVMD through 6 months compared to similar patients who receive BiV pacing. This was tested against the alternative hypothesis that patients have different changes in IVMD through 6 months with BiV pacing than RV pacing. Change was calculated as 6 month value - randomization visit value. A positive value reflected reduction in IVMD.||48.640|10.040|
72468941|NCT00267098|144461257|SUPERIORITY_OR_OTHER||Posterior BiV - RV Mean Difference|21.83|||||TWO_SIDED|95.0|2.841|40.87||BLOCK HF is a Bayesian study; a p-value was not used since it is a non-Bayesian statistical tool. Instead,a posterior distribution representing the set of possible values for the BiV - RV difference in change in IVMD through 12 months was used.|Bayesian Credible Interval||Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean IVMD change through 12 months.|The null hypothesis is that patients with AV block, NYHA I-III, and LVEF of at most 50% who receive RV pacing have similar changes in IVMD through 6 months compared to similar patients who receive BiV pacing. This was tested against the alternative hypothesis that patients have different changes in IVMD through 12 months with BiV pacing than RV pacing. Change was calculated as 12 month value - randomization visit value. A positive value reflected reduction in IVMD.||40.870|2.841|
72468942|NCT00267098|144461258|SUPERIORITY_OR_OTHER||Posterior BiV - RV Mean Difference|26.53|||||TWO_SIDED|95.0|6.247|47.19||BLOCK HF is a Bayesian study; a p-value was not used since it is a non-Bayesian statistical tool. Instead,a posterior distribution representing the set of possible values for the BiV - RV difference in change in IVMD through 18 months was used.|Bayesian Credible Interval||Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean IVMD change through 18 months.|The null hypothesis is that patients with AV block, NYHA I-III, and LVEF of at most 50% who receive RV pacing have similar changes in IVMD through 6 months compared to similar patients who receive BiV pacing. This was tested against the alternative hypothesis that patients have different changes in IVMD through 18 months with BiV pacing than RV pacing. Change was calculated as 18 month value - randomization visit value. A positive value reflected reduction in IVMD.||47.190|6.247|
72504316|NCT01025336|144539202|SUPERIORITY_OR_OTHER||Ratio|1.3|||||TWO_SIDED|95.0|0.89|2.02|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the measures \[(13vPnC - 23vPS)\].|Serotype 19F: Ratio of GMT (13vPnC to 23vPS) was calculated by back transforming the mean difference between vaccine group on the logarithmic scale||2.02|0.89|
72622082|NCT04003142|144774323|SUPERIORITY||LSMean difference|-0.18|STANDARD_ERROR_OF_MEAN|0.07||0.012|TWO_SIDED|95.0|-0.32|-0.04||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 6||-0.04|-0.32|0.012
72468943|NCT00267098|144461259|SUPERIORITY_OR_OTHER||Posterior BiV - RV Mean Difference|23.32|||||TWO_SIDED|95.0|1.999|44.53||BLOCK HF is a Bayesian study; a p-value was not used since it is a non-Bayesian statistical tool. Instead,a posterior distribution representing the set of possible values for the BiV - RV difference in change in IVMD through 24 months was used.|Bayesian Credible Interval||Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean IVMD change through 24 months.|The null hypothesis is that patients with AV block, NYHA I-III, and LVEF of at most 50% who receive RV pacing have similar changes in IVMD through 6 months compared to similar patients who receive BiV pacing. This was tested against the alternative hypothesis that patients have different changes in IVMD through 24 months with BiV pacing than RV pacing. Change was calculated as 24 month value - randomization visit value. A positive value reflected reduction in IVMD.||44.530|1.999|
72622083|NCT04003142|144774323|SUPERIORITY||LSMean difference|-0.28|STANDARD_ERROR_OF_MEAN|0.07|<|0.001||95.0|-0.42|-0.14||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 6||-0.14|-0.42|<0.001
72394883|NCT00555321|144296295|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.3|||||TWO_SIDED|95.0|-20.1|15.2|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 6||15.2|-20.1|
72394884|NCT00555321|144296295|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.0|||||TWO_SIDED|95.0|-24.0|12.5|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 12||12.5|-24.0|
72394885|NCT00555321|144296295|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.1|||||TWO_SIDED|95.0|-10.5|24.2|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 6||24.2|-10.5|
72468944|NCT00267098|144461260|SUPERIORITY_OR_OTHER||Posterior BiV - RV Mean Difference|-0.047|||||TWO_SIDED|95.0|-0.18|0.089||BLOCK HF is a Bayesian study; a p-value was not used since it is a non-Bayesian statistical tool. Instead,a posterior distribution representing the set of possible values for the BiV - RV difference in change in E/A through 6 months was used.|Bayesian Credible Interval||Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean E/A change through 6 months.|The null hypothesis is that patients with AV block, NYHA I-III, and LVEF of at most 50% who receive RV pacing have similar changes in E:A ratio (E/A) through 6 months compared to similar patients who receive BiV pacing. This was tested against the alternative hypothesis that patients have different changes in E:A ratio through 6 months with BiV pacing than RV pacing. Change was calculated as 6 month value - randomization visit value.||0.089|-0.180|
72468945|NCT00267098|144461261|SUPERIORITY_OR_OTHER||Posterior BiV - RV Mean Difference|-0.117|||||TWO_SIDED|95.0|-0.287|0.058||BLOCK HF is a Bayesian study; a p-value was not used since it is a non-Bayesian statistical tool. Instead,a posterior distribution representing the set of possible values for the BiV - RV difference in change in E/A through 12 months was used.|Bayesian Credible Interval||Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean E/A change through 12 months.|The null hypothesis is that patients with AV block, NYHA I-III, and LVEF of at most 50% who receive RV pacing have similar changes in E:A ratio (E/A) through 12 months compared to similar patients who receive BiV pacing. This was tested against the alternative hypothesis that patients have different changes in E:A ratio through 12 months with BiV pacing than RV pacing. Change was calculated as 12 month value - randomization visit value.||0.058|-0.287|
72468946|NCT00267098|144461262|SUPERIORITY_OR_OTHER||Posterior BiV - RV Mean Difference|0.041|||||TWO_SIDED|95.0|-0.136|0.22||BLOCK HF is a Bayesian study; a p-value was not used since it is a non-Bayesian statistical tool. Instead,a posterior distribution representing the set of possible values for the BiV - RV difference in change in E/A through 18 months was used.|Bayesian Credible Interval||Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean E/A change through 18 months.|The null hypothesis is that patients with AV block, NYHA I-III, and LVEF of at most 50% who receive RV pacing have similar changes in E:A ratio (E/A) through 18 months compared to similar patients who receive BiV pacing. This was tested against the alternative hypothesis that patients have different changes in E:A ratio through 18 months with BiV pacing than RV pacing. Change was calculated as 18 month value - randomization visit value.||0.220|-0.136|
72504317|NCT01025336|144539202|SUPERIORITY_OR_OTHER||Ratio|1.9|||||TWO_SIDED|95.0|1.27|2.97|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the measures \[(13vPnC - 23vPS)\].|Serotype 23F: Ratio of GMT (13vPnC to 23vPS) was calculated by back transforming the mean difference between vaccine group on the logarithmic scale||2.97|1.27|
72622084|NCT04003142|144774323|SUPERIORITY||LSMean difference|-0.16|STANDARD_ERROR_OF_MEAN|0.07||0.03|TWO_SIDED|95.0|-0.31|-0.02||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 7||-0.02|-0.31|0.030
72622085|NCT04003142|144774323|SUPERIORITY||LSMean difference|-0.28|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|95.0|-0.43|-0.14||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 7||-0.14|-0.43|<0.001
72394886|NCT00555321|144296295|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6|||||TWO_SIDED|95.0|-18.5|17.6|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 6||17.6|-18.5|
72394887|NCT00555321|144296295|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.2|||||TWO_SIDED|95.0|-23.3|9.4|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 12||9.4|-23.3|
72565147|NCT00107042|144661887|SUPERIORITY_OR_OTHER||Regression coefficient|-0.5339|STANDARD_ERROR_OF_MEAN|0.2803||0.0607||95.0|||||Regression, Linear|||This is a regression analysis for testing the effect of sexual identity(Straight (heterosexual) vs. Gay (homosexual), Bi (bisexual), and Not Sure or Undecided) on vaccine response as measured in log10 titers. The null hypothesis is no difference between groups.||||0.0607
72565148|NCT00107042|144661887|SUPERIORITY_OR_OTHER||Regression coefficient|-0.3883|STANDARD_ERROR_OF_MEAN|0.2779||0.167||95.0|||||Regression, Linear|||"This is a regression analysis for testing the effect of age at which the subject first had unforced sex (Never vs. \<= 14 year olds vs. 15-17 year olds) on vaccine response as measured in log10 titers. The null hypothesis is no difference between groups. In this statistical analysis, information for the comparison between never vs. \<= 14 year olds is presented."||||0.1670
72622086|NCT04003142|144774323|SUPERIORITY||LSMean difference|-0.13|STANDARD_ERROR_OF_MEAN|0.08||0.095|TWO_SIDED|95.0|-0.28|0.02||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 8||0.02|-0.28|0.095
72394888|NCT00555321|144296295|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.5|||||TWO_SIDED|95.0|-27.4|6.5|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 12||6.5|-27.4|
72394889|NCT00555321|144296295|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-20.1|||||TWO_SIDED|95.0|-37.5|-2.7|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 12||-2.7|-37.5|
72394890|NCT00555321|144296295|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.0|||||TWO_SIDED|95.0|-15.5|19.7|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 12||19.7|-15.5|
72394891|NCT00555321|144296295|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.3|||||TWO_SIDED|95.0|-19.4|16.9|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 12||16.9|-19.4|
72394892|NCT00555321|144296295|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.8|||||TWO_SIDED|95.0|-29.3|7.9|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 12||7.9|-29.3|
72394893|NCT00555321|144296302|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.4|||||TWO_SIDED|95.0|-6.3|36.0|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 6||36.0|-6.3|
72394894|NCT00555321|144296302|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.4|||||TWO_SIDED|95.0|-23.4|10.2|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 6||10.2|-23.4|
72394895|NCT00555321|144296302|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.2|||||TWO_SIDED|95.0|-23.4|10.0|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 6||10.0|-23.4|
72394896|NCT00555321|144296302|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3|||||TWO_SIDED|95.0|-22.0|23.4|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 6||23.4|-22.0|
72394897|NCT00555321|144296302|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.5|||||TWO_SIDED|95.0|-38.6|-0.1|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 6||-0.1|-38.6|
72394898|NCT00555321|144296302|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-21.2|||||TWO_SIDED|95.0|-39.1|-1.8|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 6||-1.8|-39.1|
72394899|NCT00555321|144296302|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.8|||||TWO_SIDED|95.0|-8.7|34.0|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 12||34.0|-8.7|
72394900|NCT00555321|144296302|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.1|||||TWO_SIDED|95.0|-25.2|8.7|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 12||8.7|-25.2|
72394901|NCT00555321|144296302|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.8|||||TWO_SIDED|95.0|-26.3|7.7|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 12||7.7|-26.3|
72394902|NCT00555321|144296302|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.4|||||TWO_SIDED|95.0|-24.5|21.1|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 12.||21.1|-24.5|
72622087|NCT04003142|144774323|SUPERIORITY||LSMean difference|-0.26|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-0.41|-0.11||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 8||-0.11|-0.41|<0.001
72565149|NCT00107042|144661887|SUPERIORITY_OR_OTHER||Regression coefficient|0.0344|STANDARD_ERROR_OF_MEAN|0.2065||0.8682||95.0|||||Regression, Linear|||"This is a regression analysis for testing the effect of age at which subject had first unforced sex (Never vs. \<= 14 year olds vs. 15 - 17 year olds) on vaccine response as measured in log10 titers. The null hypothesis is no difference between groups. In this statistical analysis, information for the comparison between never vs. 15-17 year olds is presented."||||0.8682
72565150|NCT00107042|144661887|SUPERIORITY_OR_OTHER||Regression coefficient|0.1532|STANDARD_ERROR_OF_MEAN|0.1896||0.4219||95.0|||||Regression, Linear|||This is a regression analysis for testing the effect of total number of lifetime sex partners (0 partners vs. 1-5 partners vs. \>= 6 partners) on vaccine response as measured in log10 titers. The null hypothesis is no difference between groups. In this statistical analysis, information for the comparison between 0 partners vs. 1-5 partners is presented.||||0.4219
72622088|NCT04003142|144774323|SUPERIORITY||LSMean difference|-0.13|STANDARD_ERROR_OF_MEAN|0.08||0.109|TWO_SIDED|95.0|-0.28|0.03||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 9||0.03|-0.28|0.109
72622089|NCT04003142|144774323|SUPERIORITY||LSMean difference|-0.28|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-0.43|-0.12||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 9||-0.12|-0.43|<0.001
72622090|NCT04003142|144774323|SUPERIORITY||LSMean difference|-0.19|STANDARD_ERROR_OF_MEAN|0.08||0.02||95.0|-0.35|-0.03||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 10||-0.03|-0.35|0.020
72622091|NCT04003142|144774323|SUPERIORITY||LSMean difference|-0.31|STANDARD_ERROR_OF_MEAN|0.08|<|0.001||95.0|-0.47|-0.15||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 10||-0.15|-0.47|<0.001
72622092|NCT04003142|144774323|SUPERIORITY||LSMean diferrence|-0.21|STANDARD_ERROR_OF_MEAN|0.08||0.012||95.0|-0.37|-0.05||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 11||-0.05|-0.37|0.012
72468947|NCT00267098|144461263|SUPERIORITY_OR_OTHER||Posterior BiV - RV Mean Difference|0.11|||||TWO_SIDED|95.0|-0.085|0.311||BLOCK HF is a Bayesian study; a p-value was not used since it is a non-Bayesian statistical tool. Instead,a posterior distribution representing the set of possible values for the BiV - RV difference in change in E/A through 24 months was used.|Bayesian Credible Interval||Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean E/A change through 24 months.|The null hypothesis is that patients with AV block, NYHA I-III, and LVEF of at most 50% who receive RV pacing have similar changes in E:A ratio (E/A) through 24 months compared to similar patients who receive BiV pacing. This was tested against the alternative hypothesis that patients have different changes in E:A ratio through 24 months with BiV pacing than RV pacing. Change was calculated as 24 month value - randomization visit value.||0.311|-0.085|
72468948|NCT00267098|144461264|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1841||||0.9985||95.0||||BLOCK HF is a Bayesian study; a p-value was not used. Instead, a posterior probability, representing the probability that subjects with biventricular pacing have better outcomes, was calculated. A probability ≥ 0.95 was significant.|Posterior probability of mean difference|The posterior probability that the mean difference is greater than 0 was calculated.|This was a one-sided analysis of the BiV arm - RV arm difference in Mean Clinical Composite Scores. Values above 0 suggested better outcomes in the Biventricular arm.|The null hypothesis is that patients with AV block, NYHA I-III, and LVEF of at most 50% who receive RV pacing have similar Clinical Composite Scores after 6 months compared to similar patients who receive BiV pacing. This was tested against the alternative hypothesis that patients had better scores with BiV pacing than RV pacing. The analysis assigned numerical values (Improved=3, Unchanged=2, Worsened=1) and compared the average score between randomization arms using a one-sided analysis.||||0.9985
72468949|NCT00267098|144461265|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2503||||0.9999||95.0||||BLOCK HF is a Bayesian study; a p-value was not used. Instead, a posterior probability, representing the probability that subjects with biventricular pacing have better outcomes, was calculated. A probability ≥ 0.95 was significant.|Posterior probability of mean difference|The posterior probability that the mean difference is greater than 0 was calculated.|This was a one-sided analysis of the BiV arm - RV arm difference in Mean Clinical Composite Scores. Values above 0 suggested better outcomes in the Biventricular arm.|The null hypothesis is that patients with AV block, NYHA I-III, and LVEF of at most 50% who receive RV pacing have similar Clinical Composite Scores after 12 months compared to similar patients who receive BiV pacing. This was tested against the alternative hypothesis that patients had better scores with BiV pacing than RV pacing. The analysis assigned numerical values (Improved=3, Unchanged=2, Worsened=1) and compared the average score between randomization arms using a one-sided analysis.||||0.9999
72468950|NCT00267098|144461266|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1978||||0.9978||95.0||||BLOCK HF is a Bayesian study; a p-value was not used. Instead, a posterior probability, representing the probability that subjects with biventricular pacing have better outcomes, was calculated. A probability ≥ 0.95 was significant.|Posterior probability of mean difference|The posterior probability that the mean difference is greater than 0 was calculated.|This was a one-sided analysis of the BiV arm - RV arm difference in Mean Clinical Composite Scores. Values above 0 suggested better outcomes in the Biventricular arm.|The null hypothesis is that patients with AV block, NYHA I-III, and LVEF of at most 50% who receive RV pacing have similar Clinical Composite Scores after 18 months compared to similar patients who receive BiV pacing. This was tested against the alternative hypothesis that patients had better scores with BiV pacing than RV pacing. The analysis assigned numerical values (Improved=3, Unchanged=2, Worsened=1) and compared the average score between randomization arms using a one-sided analysis.||||0.9978
72468951|NCT00267098|144461267|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2069||||0.9983||95.0||||BLOCK HF is a Bayesian study; a p-value was not used. Instead, a posterior probability, representing the probability that subjects with biventricular pacing have better outcomes, was calculated. A probability ≥ 0.95 was significant.|Posterior probability of mean difference|The posterior probability that the mean difference is greater than 0 was calculated.|This was a one-sided analysis of the BiV arm - RV arm difference in Mean Clinical Composite Scores. Values above 0 suggested better outcomes in the Biventricular arm.|The null hypothesis is that patients with AV block, NYHA I-III, and LVEF of at most 50% who receive RV pacing have similar Clinical Composite Scores after 24 months compared to similar patients who receive BiV pacing. This was tested against the alternative hypothesis that patients had better scores with BiV pacing than RV pacing. The analysis assigned numerical values (Improved=3, Unchanged=2, Worsened=1) and compared the average score between randomization arms using a one-sided analysis.||||0.9983
72468952|NCT00267098|144461269|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.23||||0.189|TWO_SIDED|95.0|0.78|2.01||BLOCK HF is a Bayesian study; a p-value was not used. Instead, a posterior probability, representing the probability that subjects with biventricular pacing have better outcomes, were calculated. A probability ≥ 0.95 was significant.|Posterior Distribution for HR|The posterior distribution is the set of values the BiV to RV hazard ratio can take, and its likelihood of taking such values.|The hazard ratio corresponds to the time from randomization to first ventricular arrhythmia occurring post-randomization for each subject. Ventricular arrhythmias occurring prior to randomization were excluded. A 95% credible interval was used.|The null hypothesis is that patients with AV block, ejection fractions of at most 50%, NYHA classifications of I-III, and indicated for defibrillation therapy who receive biventricular (BiV) pacing have the same rate of experiencing their first ventricular arrhythmia as corresponding patients who receive right ventricular pacing. This was tested against the one-side hypothesis that patients with BiV pacing have a lower risk of ventricular arrhythmias than subjects with right ventricular pacing.||2.01|0.78|0.189
72504318|NCT00736229|144539220|SUPERIORITY_OR_OTHER||||||<|0.001||||||Comparison for the difference in Median glucose values during steady state across all three groups.|Kruskal-Wallis|||Median Glucose Values (mg/dl) after steady state were evaluated across the three groups (Exenatide,Moderate and Intensive) with a Kruskal-Wallis test.||||<0.001
72504319|NCT00736229|144539220|SUPERIORITY_OR_OTHER||||||<|0.001||||||Comparison of Median Glucose Values between Exenatide and Intensive Groups.|Wilcoxon (Mann-Whitney)|||Median Glucose Values (mg/dl) after steady state were evaluated between the Exenatide and Intensive study groups using a Wilcoxon Rank Sum tests.||||<0.001
72504320|NCT00736229|144539220|SUPERIORITY_OR_OTHER|||||||0.15||||||Comparison of Median Glucose Values between Exenatide and Moderate Groups.|Wilcoxon (Mann-Whitney)|||Median Glucose Values (mg/dl) after steady state were evaluated between the Exenatide and Moderate study groups using a Wilcoxon Rank Sum tests.||||0.15
72468953|NCT01527162|144461313|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||< 0.05
72468954|NCT01527162|144461314|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.14|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||= 0.14
72565151|NCT00107042|144661887|SUPERIORITY_OR_OTHER||Regression coefficient|-0.7752|STANDARD_ERROR_OF_MEAN|0.242||0.002||95.0|||||Regression, Linear|||This is a regression analysis for testing the effect of Total Number of Lifetime Sex Partners(0 partners vs. 1-5 partners vs. \>= 6 partners) on vaccine response as measured in log10 titers. The null hypothesis is no difference between groups. In this statistical analysis, information for the comparison between 0 partners vs. \>= 6 partners is presented.||||0.0020
72565152|NCT00107042|144661887|SUPERIORITY_OR_OTHER||Regression coefficient|0.2921|STANDARD_ERROR_OF_MEAN|0.2086||0.1659||95.0|||||Regression, Linear|||This is a regression analysis for testing the effect of Total Number of Male Lifetime Sex Partners(0 partners vs. 1-5 partners vs. \>= 6 partners) on vaccine response as measured in log10 titers. The null hypothesis is no difference between groups. In this statistical analysis, information for the comparison between 0 partners vs. 1-5 partners is presented.||||0.1659
72565153|NCT00107042|144661887|SUPERIORITY_OR_OTHER||Regression coefficient|-1.6163|STANDARD_ERROR_OF_MEAN|0.2839||0||95.0|||||Regression, Linear|||This is a regression analysis for testing the effect of Total Number of Male Lifetime Sex Partners(0 partners vs. 1-5 partners vs. \>= 6 partners) on vaccine response as measured in log10 titers. The null hypothesis is no difference between groups. In this statistical analysis, information for the comparison between 0 partners vs. \>= 6 partners is presented.||||0.0000
72565154|NCT00107042|144661887|SUPERIORITY_OR_OTHER||Regression coefficient|-0.1788|STANDARD_ERROR_OF_MEAN|0.2463||0.4701||95.0|||||Regression, Linear|||This is a regression analysis for testing the effect of Total Number of Female Lifetime Sex Partners(0 partners vs. 1-5 partners vs. \>= 6 partners) on vaccine response as measured in log10 titers. The null hypothesis is no difference between groups. In this statistical analysis, information for the comparison between 0 partners vs. 1-5 partners is presented.||||0.4701
72622093|NCT04003142|144774323|SUPERIORITY||LSMean difference|-0.31|STANDARD_ERROR_OF_MEAN|0.08|<|0.001||95.0|-0.47|-0.15||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 11||-0.15|-0.47|<0.001
72468955|NCT01527162|144461315|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.54|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Paired Wilcoxon Sign Rank TEst||||>.54
72504321|NCT00736229|144539221|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Kruskal-Wallis|||Median Time (Hrs) to steady state was evaluated across the three groups (exenatide, moderate and intensive) with a Kruskal-Wallis test.||||<0.001
72504322|NCT00736229|144539221|SUPERIORITY_OR_OTHER|||||||0.8|||||||Wilcoxon (Mann-Whitney)|||Median time (hours) to steady state were evaluated between the Exenatide and Intensive study groups using a Wilcoxon Rank Sum tests.||||0.80
72504323|NCT00736229|144539221|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Median time (hours) to steady state were evaluated between the Exenatide and Moderate study groups using a Wilcoxon Rank Sum tests.||||<0.001
72565155|NCT00107042|144661887|SUPERIORITY_OR_OTHER||Regression coefficient|0.1083|STANDARD_ERROR_OF_MEAN|0.3488||0.7572||95.0|||||Regression, Linear|||This is a regression analysis for testing the effect of Total Number of Female Lifetime Sex Partners(0 partners vs. 1-5 partners vs. \>= 6 partners) on vaccine response as measured in log10 titers. The null hypothesis is no difference between groups. In this statistical analysis, information for the comparison between 0 partners vs. \>= 6 partners is presented.||||0.7572
72468956|NCT01527162|144461315|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.2|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||= 0.20
72468957|NCT04599907|144461317|SUPERIORITY||||||<|0.05|||||||Cochran-Mantel-Haenszel|||||||<0.05
72468958|NCT04599907|144461318|SUPERIORITY||Mean Difference (Final Values)|-0.91|||<|0.05|TWO_SIDED|95.0|-1.42|-0.04|||Mixed Models Analysis|||"This is the data for the Level of Botherstatistical analysis"||-0.040|-1.42|<0.05
72468959|NCT04599907|144461318|SUPERIORITY||Mean Difference (Final Values)|-0.87|||<|0.05|TWO_SIDED|95.0|-1.35|-0.4|||Mixed Models Analysis|||"This is the data for the Level of Impact on Daily Activities Statistical Analysis"||-0.40|-1.35|<0.05
72468960|NCT02104505|144461426|SUPERIORITY||Mean Difference (Net)|0.41|STANDARD_ERROR_OF_MEAN|0.18||0.04|TWO_SIDED||||||Mixed Models Analysis||Comparison of change in sputum %PMNs during active treatment vs placebo (crossover design).|||||0.04
72468961|NCT02104505|144461427|SUPERIORITY||Mean Difference (Net)|0.64|STANDARD_ERROR_OF_MEAN|0.22||0.01|TWO_SIDED||||||Mixed Models Analysis|||||||0.01
72468962|NCT02104505|144461428|SUPERIORITY||Mean Difference (Net)|-0.32|STANDARD_ERROR_OF_MEAN|0.33||0.6|TWO_SIDED||||||Mixed Models Analysis|||||||0.6
72468963|NCT02104505|144461429|SUPERIORITY||Mean Difference (Net)|-0.32|STANDARD_ERROR_OF_MEAN|0.33||0.34|TWO_SIDED||||||Mixed Models Analysis|||||||0.34
72468964|NCT03121820|144461440|NON_INFERIORITY_OR_EQUIVALENCE|The analysis was conducted using an analysis of variance (ANOVA) including fixed effects for treatment, sequence, period and subject within sequence. All pharmacokinetic parameters were log-transformed prior to analysis. Bioequivalence was concluded, when the 90% confidence interval (CI) for the geometric mean ratios were fully contained within the predefined equivalence limits of 80.00 % to 125.00 %|Test/Ref Geometric mean ratio x 100|93.8||||0.05|TWO_SIDED|90.0|88.25|99.77|||Test/Ref Geometric mean ratio x 100|Bioequivalence is established when 90% Confidence Interval falls within 80.00 % -125.00 %.||Memantinol 20 mg Tablets Versus Akatinol Memantine® 20 mg||99.77|88.25|0.05
72504324|NCT02723630|144539229|SUPERIORITY_OR_OTHER||Geometric Least Square Mean Ratio|100.52||||0.8826|TWO_SIDED|90.0|94.84|106.53||P-value for the formulation|Mixed Models Analysis||Geometric LS Mean ratio was back-transformed least squares mean and mean treatment difference.|The effect of crystalline polymorph forms in the drug product on the PK parameters of lenvatinib was estimated using a mixed linear model of logarithmically transformed values of the primary PK parameters with fixed effects for treatment, period, and sequence and a random effect for participant within sequence.||106.53|94.84|0.8826
72622094|NCT04003142|144774324|SUPERIORITY||LSMean difference|-12.16|STANDARD_ERROR_OF_MEAN|3.43|<|0.001||95.0|-18.9|-5.43||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 1||-5.43|-18.90|<0.001
72622095|NCT04003142|144774324|SUPERIORITY||LSMean difference|-15.68|STANDARD_ERROR_OF_MEAN|3.44|<|0.001||95.0|-22.44|-8.91||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 1||-8.91|-22.44|<0.001
72468965|NCT03121820|144461441|NON_INFERIORITY_OR_EQUIVALENCE|The analysis was conducted using an analysis of variance (ANOVA) including fixed effects for treatment, sequence, period and subject within sequence. All pharmacokinetic parameters were log-transformed prior to analysis. Bioequivalence was concluded, when the 90% confidence interval (CI) for the geometric mean ratios were fully contained within the predefined equivalence limits of 80.00 % to 125.00 %|Test/Ref Geometric mean ratio x 100|92.3||||0.05|TWO_SIDED|90.0|86.37|98.55|||Test/Ref Geometric mean ratio x 100|Bioequivalence is established when 90% Confidence Interval falls within 80.00 % -125.00 %.||Memantinol 20 mg Tablets Versus Akatinol Memantine® 20 mg||98.55|86.37|0.05
72468966|NCT00730015|144461442|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|7.72|||<|0.0001|TWO_SIDED|95.0|3.41|17.47||The p-value is still less than 0.05 after adjusting multiplicity using a serial gatekeeping multiple comparison procedure.|Cochran-Mantel-Haenszel|||Null hypothesis: There is no difference in the proportion of 12-week CSBM overall responders between patients taking the 145-μg dose and those taking placebo. The power, adjusted for multiplicity, was expected to be at least 90% based on study NCT00402337(MCP-103-201) data.||17.47|3.41|<0.0001
72468967|NCT00730015|144461442|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|7.21|||<|0.0001|TWO_SIDED|95.0|3.14|16.59||The p-value is still less than 0.05 after adjusting multiplicity using a serial gatekeeping multiple comparison procedure.|Cochran-Mantel-Haenszel|||Null hypothesis: There is no difference in the proportion of 12-week CSBM overall responders between patients taking the 290-μg dose and those taking placebo. The power, adjusted for multiplicity, was expected to be greater than 96% based on study NCT00402337(MCP-103-201) data.||16.59|3.14|<0.0001
72468968|NCT02641587|144461454|OTHER|"The analysis will test if the geometric LS mean level of MHBMA for CHTP is lower than for CC. The following hypothesis will be evaluated:~H0: XCHTP - XCC ≤ 0.0~HA: XCHTP - XCC \> 0.0~where XCHTP and XCC are the geometric LS means of CHTP and CC, respectively. H0 is rejected with a type I error α = 2.5% (one-sided test)."|LS Mean Reduction|85.01|||<|0.001|TWO_SIDED|95.0|82.06|87.47||The primary endpoints will be tested using a multiple testing procedure to preserve the overall alpha level by simultaneously testing the endpoints using a closed procedure with each test performed at an alpha level of 2.5% one sided.|Generalized linear model||Least squares (LS) means and estimate of the difference, and 95% CI will be back-transformed for obtaining geometric LS means for each arm, the reduction (calculated as 100% - ratio of CHTP 1.2 : CC \[%\]), and their 95% CI.|Analysis will be conducted on the natural log scale. The Day 5 levels of MHBMA will be analyzed by means of a generalized linear model using randomized arm as covariate adjusting for sex, average cigarette consumption over the previous 6 weeks prior to Admission (value at Admission for stratification), and log-transformed baseline value of MHBMA.||87.47|82.06|<0.001
72504325|NCT02723630|144539229|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean Ratio|96.03||||0.1095|TWO_SIDED|90.0|92.11|100.12||P-value for formulation|Mixed Models Analysis||Geometric LS Mean ratio was back-transformed least squares mean and mean treatment difference.|The effect of crystalline polymorph forms in the drug product on the PK parameters of lenvatinib was estimated using a mixed linear model of logarithmically transformed values of the primary PK parameters with fixed effects for treatment, period, and sequence and a random effect for participant within sequence.||100.12|92.11|0.1095
72468969|NCT02641587|144461455|OTHER|"The analysis will test if the geometric LS mean level of 3-HPMA for CHTP is lower than for CC. The following hypothesis will be evaluated:~H0: XCHTP - XCC ≤ 0.0~HA: XCHTP - XCC \> 0.0~where XCHTP and XCC are the geometric LS means of CHTP and CC, respectively. H0 is rejected with a type I error α = 2.5% (one-sided test)."|LS Mean Reduction|40.2|||<|0.001|TWO_SIDED|95.0|30.25|48.73||The primary endpoints will be tested using a multiple testing procedure to preserve the overall alpha level by simultaneously testing the endpoints using a closed procedure with each test performed at an alpha level of 2.5% one sided.|Generalized linear model||Least squares (LS) means and estimate of the difference, and 95% CI will be back-transformed for obtaining geometric LS means for each arm, the reduction (calculated as 100% - ratio of CHTP 1.2 : CC \[%\]), and their 95% CI.|Analysis will be conducted on the natural log scale. The Day 5 levels of 3-HPMA will be analyzed by means of a generalized linear model using randomized arm as covariate adjusting for sex, average cigarette consumption over the previous 6 weeks prior to Admission (value at Admission for stratification), and log-transformed baseline value of 3-HPMA.||48.73|30.25|<0.001
72468970|NCT02641587|144461456|OTHER|"The analysis will test if the geometric LS mean level of S-PMA for CHTP is lower than for CC. The following hypothesis will be evaluated:~H0: XCHTP - XCC ≤ 0.0~HA: XCHTP - XCC \> 0.0~where XCHTP and XCC are the geometric LS means of CHTP and CC, respectively. H0 is rejected with a type I error α = 2.5% (one-sided test)."|LS Mean Reduction|83.9|||<|0.001|TWO_SIDED|95.0|81.61|85.9||The primary endpoints will be tested using a multiple testing procedure to preserve the overall alpha level by simultaneously testing the endpoints using a closed procedure with each test performed at an alpha level of 2.5% one sided.|Generalized linear model||Least squares (LS) means and estimate of the difference, and 95% CI will be back-transformed for obtaining geometric LS means for each arm, the reduction (calculated as 100% - ratio of CHTP 1.2 : CC \[%\]), and their 95% CI.|Analysis will be conducted on the natural log scale. The Day 5 levels of S-PMA will be analyzed by means of a generalized linear model using randomized arm as covariate adjusting for sex, average cigarette consumption over the previous 6 weeks prior to Admission (value at Admission for stratification), and log-transformed baseline value of S-PMA.||85.90|81.61|<0.001
72468971|NCT02641587|144461457|OTHER|"The analysis will test if the geometric LS mean level of COHb for CHTP is lower than for CC. The following hypothesis will be evaluated:~H0: XCHTP - XCC ≤ 0.0~HA: XCHTP - XCC \> 0.0~where XCHTP and XCC are the geometric LS means of CHTP and CC, respectively. H0 is rejected with a type I error α = 2.5% (one-sided test)."|LS Mean Reduction|55.74|||<|0.001|TWO_SIDED|95.0|49.03|61.56||The primary endpoints will be tested using a multiple testing procedure to preserve the overall alpha level by simultaneously testing the endpoints using a closed procedure with each test performed at an alpha level of 2.5% one sided.|Generalized linear model||Least squares (LS) means and estimate of the difference, and 95% CI will be back-transformed for obtaining geometric LS means for each arm, the reduction (calculated as 100% - ratio of CHTP 1.2 : CC \[%\]), and their 95% CI.|Analysis will be conducted on the natural log scale. The Day 5 levels of COHb will be analyzed by means of a generalized linear model using randomized arm as covariate adjusting for sex, average cigarette consumption over the previous 6 weeks prior to Admission (value at Admission for stratification), and log-transformed baseline value of COHb.||61.56|49.03|<0.001
72468972|NCT02641587|144461458|OTHER|"The analysis will test if the geometric LS mean level of Total NNAL for CHTP is lower than for CC. The following hypothesis will be evaluated:~H0: XCHTP - XCC ≤ 0.0~HA: XCHTP - XCC \> 0.0~where XCHTP and XCC are the geometric LS means of CHTP and CC, respectively. H0 is rejected with a type I error α = 2.5% (one-sided test)."|LS Mean Reduction|79.36|||<|0.001|TWO_SIDED|95.0|72.73|84.39||The primary endpoints will be tested using a multiple testing procedure to preserve the overall alpha level by simultaneously testing the endpoints using a closed procedure with each test performed at an alpha level of 2.5% one sided.|Generalized linear model||Least squares (LS) means and estimate of the difference, and 95% CI will be back-transformed for obtaining geometric LS means for each arm, the reduction (calculated as 100% - ratio of CHTP 1.2 : CC \[%\]), and their 95% CI.|Analysis will be conducted on the natural log scale. The Day 5 levels of Total NNAL will be analyzed by means of a generalized linear model using randomized arm as covariate adjusting for sex, average cigarette consumption over the previous 6 weeks prior to Admission (value at Admission for stratification), and log-transformed baseline value of Total NNAL.||84.39|72.73|<0.001
72504326|NCT02723630|144539230|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean Ratio|100.8||||0.8121|TWO_SIDED|90.0|95.31|106.61||P value for formulation|Mixed Models Analysis||Geometric LS Mean ratio was back-transformed least squares mean and treatment difference mean|The effect of crystalline polymorph forms in the drug product on the PK parameters of lenvatinib was estimated using a mixed linear model of logarithmically transformed values of the primary PK parameters with fixed effects for treatment, period, and sequence and a random effect for participant within sequence.||106.61|95.31|0.8121
72504327|NCT02723630|144539230|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean Ratio|96.51||||0.163|TWO_SIDED|90.0|92.53|100.65||P value for formulation|Mixed Models Analysis||Geometric LS Mean ratio was back-transformed least squares mean and treatment difference mean|The effect of crystalline polymorph forms in the drug product on the PK parameters of lenvatinib was estimated using a mixed linear model of logarithmically transformed values of the primary PK parameters with fixed effects for treatment, period, and sequence and a random effect for participant within sequence.||100.65|92.53|0.1630
72565156|NCT00107042|144661887|SUPERIORITY_OR_OTHER||Regression coefficient|-0.0307|STANDARD_ERROR_OF_MEAN|0.1809||0.8657||95.0|||||Regression, Linear|||This is a regression analysis for testing the effect of whether a subject ever drank alcohol (No vs. Yes) on vaccine response as measured in log10 titers. The null hypothesis is no difference between groups.||||0.8657
72565157|NCT00107042|144661887|SUPERIORITY_OR_OTHER||Regression coefficient|-0.3548|STANDARD_ERROR_OF_MEAN|0.2076||0.0917||95.0|||||Regression, Linear|||This is a regression analysis for testing the effect of whether a subject ever smoked marijuana(No vs. Yes) on vaccine response as measured in log10 titers. The null hypothesis is no difference between groups.||||0.0917
72622096|NCT04003142|144774324|SUPERIORITY||LSMean difference|-14.61|STANDARD_ERROR_OF_MEAN|3.81|<|0.001|TWO_SIDED|95.0|-22.09|-7.13||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 2||-7.13|-22.09|<0.001
72394903|NCT00555321|144296302|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-22.2|||||TWO_SIDED|95.0|-40.5|-1.9|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 12||-1.9|-40.5|
72622097|NCT04003142|144774324|SUPERIORITY||LSMean difference|-15.95|STANDARD_ERROR_OF_MEAN|3.82|<|0.001|TWO_SIDED|95.0|-23.45|-8.45||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 2||-8.45|-23.45|<0.001
72622098|NCT04003142|144774324|SUPERIORITY||LSMean difference|-15.51|STANDARD_ERROR_OF_MEAN|3.89|<|0.001||95.0|-23.16|-7.86||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 3||-7.86|-23.16|<0.001
72622099|NCT04003142|144774324|SUPERIORITY||LSMean difference|-20.25|STANDARD_ERROR_OF_MEAN|3.9|<|0.001||95.0|-27.91|-12.59||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 3||-12.59|-27.91|<0.001
72468973|NCT01165177|144461459|OTHER|Criteria for the vaccine efficacy (VE) objective of herpes zoster subunit (HZ/su) vaccine against herpes zoster (HZ) disease, in the 50-59 YOA strata : The lower limit (LL) of the two-sided 95% confidence interval (CI) of VE had to be above 10%.|Vaccine efficacy|96.6|||<|0.0001|TWO_SIDED|95.0|89.6|99.3||Two sided exact P-value conditional to number of cases.|Poisson exact test|||Comparison of vaccine efficacy in prevention of HZ between GSK1437173A 50-59 YOA group and placebo 50-59 YOA group||99.3|89.6|<0.0001
72468974|NCT01165177|144461459|OTHER|Criteria for the VE objective of HZ/su vaccine against herpes zoster disease, in the 60-69 YOA strata : The lower limit (LL) of the two-sided 95% confidence interval (CI) of VE had to be above 10%.|Vaccine efficacy|97.4|||<|0.0001|TWO_SIDED|95.0|90.1|99.7||Two sided exact P-value conditional to number of cases.|Poisson exact test|||Comparison of vaccine efficacy in prevention of HZ between GSK1437173A over 60-69 YOA group and placebo over 60-69 YOA group||99.7|90.1|<0.0001
72468975|NCT01165177|144461459|OTHER|Criteria for the VE objective of HZ/su vaccine against herpes zoster disease, in the 70-79 YOA strata : The lower limit (LL) of the two-sided 95% confidence interval (CI) of VE had to be above 10%.|Vaccine efficacy|97.9||||0.0001|TWO_SIDED|95.0|87.9|100.0||Two sided exact P-value conditional to number of cases.|Poisson exact test|||Comparison of vaccine efficacy in prevention of HZ between GSK1437173A over 70 YOA group and placebo over 70 YOA group||100|87.9|0.0001
72468976|NCT01165177|144461459|OTHER|Criteria for the VE objective of HZ/su vaccine against herpes zoster disease, in the overall age strata : The lower limit (LL) of the two-sided 95% confidence interval (CI) of VE had to be above 10%.|Vaccine efficacy|97.2|||<|0.0001|TWO_SIDED|95.0|93.7|99.0||Two sided exact P-value conditional to number of cases.|Poisson exact test|||Comparison of vaccine efficacy in prevention of HZ between GSK1437173A overall ages group and placebo overall ages group||99|93.7|<0.0001
72622100|NCT04003142|144774324|SUPERIORITY||LSMean difference|-16.34|STANDARD_ERROR_OF_MEAN|3.92|<|0.001||95.0|-24.04|-8.63||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 4||-8.63|-24.04|<0.001
72468977|NCT01165177|144461460|OTHER|Criteria for the VE objective of HZ/su vaccine against PHN in the 50-59 YOA strata: The lower limit of the 95% CI of VE had to be above 0%|Vaccine efficacy|100.0||||0.0081|TWO_SIDED|95.0|40.9|100.0|||Poisson exact test|||Comparison of vaccine efficacy in prevention of PHN between GSK1437173A 50-59 YOA group and placebo 50-59 YOA group||100|40.9|0.0081
72468978|NCT01165177|144461460|OTHER|Criteria for VE objective of HZ/su vaccine against PHN in the 60-69 YOA strata: The lower limit of the 95% CI of VE had to be above 0%|Vaccine efficacy|100.0||||0.5097|TWO_SIDED|95.0|-442.8|100.0|||Poisson exact test|||Comparison of vaccine efficacy in prevention of PHN between GSK1437173A 60-69 YOA group and placebo 60-69 YOA group||100|-442.8|0.5097
72468979|NCT01165177|144461460|OTHER|Criteria for the VE objective of HZ/su vaccine against PHN in the 70-79 YOA strata: The lower limit of the 95% CI of VE had to be above 0%|Vaccine efficacy|100.0||||0.0078|TWO_SIDED|95.0|41.4|100.0|||Poisson exact test|||Comparison of vaccine efficacy in prevention of PHN between GSK1437173A over 70 YOA group and placebo over 70 YOA group||100|41.4|0.0078
72468980|NCT01165177|144461460|OTHER|Criteria for the VE objective of HZ/su vaccine against PHN in the overall ages strata: The lower limit of the 95% CI of VE had to be above 0%|Vaccine efficacy|100.0|||<|0.0001|TWO_SIDED|95.0|77.1|100.0|||Poisson exact test|||Comparison of vaccine efficacy in prevention of PHN between GSK1437173A overall ages group and placebo overall ages group||100|77.1|<0.0001
72468981|NCT01663506|144461487|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.01|TWO_SIDED||||||Wilcoxon's signed-rank test|||Change from Baseline at Month 3||||<0.01
72468982|NCT01663506|144461487|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.01|TWO_SIDED||||||Wilcoxon's signed-rank test|||Change from Baseline at Month 6||||<0.01
72468983|NCT01663506|144461487|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.01|TWO_SIDED||||||Wilcoxon's signed-rank test|||Change from Baseline at Month 12||||<0.01
72394904|NCT00555321|144296302|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-23.9|||||TWO_SIDED|95.0|-41.8|-4.3|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 12||-4.3|-41.8|
72394905|NCT03334448|144296348|SUPERIORITY||Ratio of Geometric Least Square Means|0.83|||||TWO_SIDED|90.0|0.818|0.957||||||||0.957|0.818|
72394906|NCT03334448|144296349|SUPERIORITY||Ration of Lease Square Means|0.97|||||TWO_SIDED|90.0|0.83|1.09||||||||1.09|0.83|
72394907|NCT01683383|144296354|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Adjusted Wald estimation|||||||<0.001
72394908|NCT01683383|144296355|SUPERIORITY_OR_OTHER|||||||0.04|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.04
72394909|NCT01683383|144296357|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<0.001
72394910|NCT00996307|144296364|NON_INFERIORITY_OR_EQUIVALENCE|The two-sided confidence intervals (CIs) were calculated and assessed for non-inferiority first against the margin of 0.5 (exploratory margin) and in case of success against the margin of 0.667 (based on CBER guidance against the licensed comparator).|Ratio of GMTs|4.06|||||TWO_SIDED|95.0|2.55|6.46|||||Ratio of GMTs at Day 22|||6.46|2.55|
72394911|NCT00996307|144296364|NON_INFERIORITY_OR_EQUIVALENCE|The two-sided CIs were calculated and assessed for non-inferiority first against the margin of 0.5 (exploratory margin) and in case of success against the margin of 0.667 (based on CBER guidance against the licensed comparator).|Ratio of GMTs|2.25|||||TWO_SIDED|95.0|1.42|3.56|||||Ratio of GMTs at Day 22|||3.56|1.42|
72394912|NCT00996307|144296364|NON_INFERIORITY_OR_EQUIVALENCE|The two-sided CIs were calculated and assessed for non-inferiority first against the margin of 0.5 (exploratory margin) and in case of success against the margin of 0.667 (based on CBER guidance against the licensed comparator).|Ratio of GMTs|4.49|||||TWO_SIDED|95.0|2.8|7.19|||||Ratio of GMTs at Day 22|||7.19|2.8|
72394913|NCT00996307|144296364|NON_INFERIORITY_OR_EQUIVALENCE|The two-sided CIs were calculated and assessed for non-inferiority first against the margin of 0.5 (exploratory margin) and in case of success against the margin of 0.667 (based on CBER guidance against the licensed comparator).|Ratio of GMTs|2.49|||||TWO_SIDED|95.0|1.56|3.96|||||Ratio of GMTs at Day 22|||3.96|1.56|
72394914|NCT00996307|144296364|NON_INFERIORITY_OR_EQUIVALENCE|The two-sided CIs were calculated and assessed for non-inferiority first against the margin of 0.5 (exploratory margin) and in case of success against the margin of 0.667 (based on CBER guidance against the licensed comparator).|Ratio of GMTs|8.01|||||TWO_SIDED|95.0|5.52|12.0|||||Ratio of GMTs at Day 43|||12|5.52|
72394915|NCT00996307|144296364|NON_INFERIORITY_OR_EQUIVALENCE|The two-sided CIs were calculated and assessed for non-inferiority first against the margin of 0.5 (exploratory margin) and in case of success against the margin of 0.667 (based on CBER guidance against the licensed comparator).|Ratio of GMTs|4.25|||||TWO_SIDED|95.0|2.94|6.15|||||Ratio of GMTs at Day 43|||6.15|2.94|
72394916|NCT00996307|144296364|NON_INFERIORITY_OR_EQUIVALENCE|The two-sided CIs were calculated and assessed for non-inferiority first against the margin of 0.5 (exploratory margin) and in case of success against the margin of 0.667 (based on CBER guidance against the licensed comparator).|Ratio of GMTs|7.81|||||TWO_SIDED|95.0|5.36|11.0|||||Ratio of GMTs at Day 43|||11|5.36|
72394917|NCT00996307|144296364|NON_INFERIORITY_OR_EQUIVALENCE|The two-sided CIs were calculated and assessed for non-inferiority first against the margin of 0.5 (exploratory margin) and in case of success against the margin of 0.667 (based on CBER guidance against the licensed comparator).|Ratios of GMTs|4.15|||||TWO_SIDED|95.0|2.86|6.02|||||Ratio of GMTs at Day 43|||6.02|2.86|
72394918|NCT00996307|144296364|SUPERIORITY_OR_OTHER||Ratio of GMTs|3.66|||||TWO_SIDED|95.0|2.37|5.65||||||Superiority of the adjuvanted vaccines against the non-adjuvanted vaccines was to be tested against the margin of 1 on day 22||5.65|2.37|
72622101|NCT04003142|144774324|SUPERIORITY||LSMean difference|-21.65|STANDARD_ERROR_OF_MEAN|3.92|<|0.001||95.0|-29.36|-13.94||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 4||-13.94|-29.36|<0.001
72394919|NCT00996307|144296364|SUPERIORITY_OR_OTHER||Ratio of GMTs|2.21|||||TWO_SIDED|95.0|1.43|3.4||||||Superiority of the adjuvanted vaccines against the non-adjuvanted vaccines was to be tested against the margin of 1 on day 22.||3.4|1.43|
72394920|NCT00996307|144296364|SUPERIORITY_OR_OTHER||Ratio of GMTs|4.42|||||TWO_SIDED|95.0|2.85|6.86||||||Superiority of the adjuvanted vaccines against the non-adjuvanted vaccines was to be tested against the margin of 1 on day 22.||6.86|2.85|
72394921|NCT00996307|144296364|SUPERIORITY_OR_OTHER||Ratio of GMTs|2.67|||||TWO_SIDED|95.0|1.72|4.13||||||Superiority of the adjuvanted vaccines against the non-adjuvanted vaccines was to be tested against the margin of 1 on day 22.||4.13|1.72|
72394922|NCT00996307|144296364|SUPERIORITY_OR_OTHER||Ratio of GMTs|7.82|||||TWO_SIDED|95.0|5.54|11.0||||||Superiority of the adjuvanted vaccines against the non-adjuvanted vaccines was to be tested against the margin of 1 on day 43.||11|5.54|
72394923|NCT00996307|144296364|SUPERIORITY_OR_OTHER||Ratio of GMTs|4.55|||||TWO_SIDED|95.0|3.23|6.42||||||Superiority of the adjuvanted vaccines against the non-adjuvanted vaccines||6.42|3.23|
72394924|NCT00996307|144296364|SUPERIORITY_OR_OTHER||Ratio of GMTs|7.52|||||TWO_SIDED|95.0|5.3|11.0||||||Superiority of the adjuvanted vaccines against the non-adjuvanted vaccines was to be tested against the margin of 1 on day 43.||11|5.3|
72394925|NCT00996307|144296364|SUPERIORITY_OR_OTHER||Ratio of GMTs|4.37|||||TWO_SIDED|95.0|3.09|6.19||||||Superiority of the adjuvanted vaccines against the non-adjuvanted vaccines was to be tested against the margin of 1 on day 43.||6.19|3.09|
72394926|NCT01767155|144296376|OTHER||Kaplan-Meier|69.8|||||TWO_SIDED|95.0|63.6|75.1||||||Kaplan-Meier log-log transformed estimates: survivors at 6 months||75.1|63.6|
72394927|NCT01767155|144296376|OTHER||Kaplan-Meier|45.8|||||TWO_SIDED|95.0|39.5|52.0||||||Kaplan-Meier log-log transformed estimates: survivors at 12 months||52.0|39.5|
72394928|NCT01767155|144296376|OTHER||Kaplan-Meier|72.1|||||TWO_SIDED|95.0|66.0|77.3||||||Kaplan-Meier log-log transformed estimates: survivors at 6 months||77.3|66.0|
72394929|NCT01767155|144296376|OTHER||Kaplan-Meier|44.6|||||TWO_SIDED|95.0|38.2|50.7||||||Kaplan-Meier log-log transformed estimates: survivors at 12 months||50.7|38.2|
72394930|NCT01767155|144296376|OTHER||Hazard Ratio (HR)|1.06||||0.5441|TWO_SIDED|95.0|0.87|1.3|||Log Rank|2-sided||A Cox model with treatment effects was used to estimate the hazard ratio and perform hypothesis testing. The estimated hazard ratio and the 95% CI of the hazard ratio were presented.||1.30|0.87|0.5441
72468984|NCT01663506|144461489|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Wilcoxon's signed-rank test|||Change from Baseline at Month 6||||<0.001
72394931|NCT01767155|144296377|OTHER||Odds Ratio (OR)|0.87||||0.5907|TWO_SIDED|95.0|0.52|1.45|||Mantel Haenszel|2-sided test||Hypothesis testing between the two treatment arms was performed using a Mantel Haenszel test. The odds ratio and 95% CI of the odds ratio were presented.||1.45|0.52|0.5907
72394932|NCT01767155|144296378|OTHER||Kaplan-Meier|46.7|||||TWO_SIDED|95.0|39.5|53.6||||||Kaplan-Meier log-log transformed estimates: survivors at 6 months.||53.6|39.5|
72394933|NCT01767155|144296378|OTHER||Kaplan-Meier|20.6|||||TWO_SIDED|95.0|14.6|27.4||||||Kaplan-Meier log-log transformed estimates: survivors at 12 months||27.4|14.6|
72394934|NCT01767155|144296378|OTHER||Kaplan-Meier|47.5|||||TWO_SIDED|95.0|40.0|54.7||||||Kaplan-Meier log-log transformed estimates: survivors at 6 months||54.7|40.0|
72394935|NCT01767155|144296378|OTHER||Kaplan-Meier|12.3|||||TWO_SIDED|95.0|6.9|19.3||||||Kaplan-Meier log-log transformed estimates: survivors at 12 months||19.3|6.9|
72394936|NCT01767155|144296378|OTHER||Hazard Ratio (HR)|0.89||||0.3089|TWO_SIDED|95.0|0.71|1.11|||Log Rank|2-sided||Hypothesis testing between the two treatment arms was performed using a log rank test.||1.11|0.71|0.3089
72394937|NCT01767155|144296379|OTHER||Odds Ratio (OR)|1.07||||0.6924|TWO_SIDED|95.0|0.76|1.52|||Mantel Haenszel|2-sided||Hypothesis testing between the two treatment arms was performed using a Mantel Haenszel test.||1.52|0.76|0.6924
72394938|NCT00371137|144296393|SUPERIORITY_OR_OTHER||||||>|0.001||95.0|||||Chi-squared|||Overall Comparison||||>0.001
72468985|NCT01663506|144461489|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||Wilcoxon's signed-rank test|||Change from Baseline at Month 12||||<0.0001
72468986|NCT01663506|144461490|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05|TWO_SIDED||||||Wilcoxon's signed-rank test|||Change from Baseline at Month 6||||<0.05
72565158|NCT00107042|144661887|SUPERIORITY_OR_OTHER||Regression coefficient|-0.3474|STANDARD_ERROR_OF_MEAN|0.3924||0.3788||95.0|||||Regression, Linear|||This is a regression analysis for testing the effect of whether a subject ever used drugs not prescribed(No vs. Yes) on vaccine response as measured in log10 titers. The null hypothesis is no difference between groups.||||0.3788
72565159|NCT00107042|144661888|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.54||||0.2068|TWO_SIDED|95.0|0.6|10.76|||Univariate regression, logistic||The reference group is the 'Recombivax' group.|||10.76|0.60|0.2068
72394939|NCT00371137|144296393|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||Pairwise comparison of placebo and Xyrem 4.5g||||<0.001
72394940|NCT00371137|144296393|SUPERIORITY_OR_OTHER|||||||0.015||95.0|||||Chi-squared|||Pairwise comparison of placebo and Xyrem 6.0g||||0.015
72468987|NCT01663506|144461490|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||Wilcoxon's signed-rank test|||Change from Baseline at Month 12||||<0.0001
72468988|NCT01663506|144461492|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05|TWO_SIDED||||||Wilcoxon's signed-rank test|||Change from Baseline at Month 6||||<0.05
72468989|NCT01663506|144461492|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.01|TWO_SIDED||||||Wilcoxon's signed-rank test|||Change from Baseline at Month 12||||<0.01
72565160|NCT00107042|144661889|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.52||||0.5524|TWO_SIDED|95.0|0.38|6.01|||Univariate regression, logistic||The reference group is the 'Other Sites' group.|||6.01|0.38|0.5524
72565161|NCT00107042|144661890|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.84||||0.4646|TWO_SIDED|95.0|0.36|9.36|||Univariate regression, logistic||The reference group is the '15-17 year' age group|||9.36|0.36|0.4646
72565162|NCT00107042|144661891|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.45||||0.339|TWO_SIDED|95.0|0.09|2.3|||Univariate regression, logistic||The reference group is the 'Female' group.|||2.30|0.09|0.3390
72622102|NCT04003142|144774324|SUPERIORITY||LSMean difference|-15.62|STANDARD_ERROR_OF_MEAN|3.89|<|0.001|TWO_SIDED|95.0|-23.27|-7.98||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 5||-7.98|-23.27|<0.001
72622103|NCT04003142|144774324|SUPERIORITY||LSMean difference|-22.88|STANDARD_ERROR_OF_MEAN|3.89|<|0.001||95.0|-30.52|-15.24||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 5||-15.24|-30.52|<0.001
72394941|NCT00536198|144296394|SUPERIORITY_OR_OTHER|||||||0.21|TWO_SIDED||||||ANOVA|||Group comparison||||0.21
72394942|NCT00536198|144296394|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANOVA|||Change over time in both groups||||<0.001
72394943|NCT00536198|144296394|SUPERIORITY_OR_OTHER|||||||0.06|TWO_SIDED||||||ANOVA|||Group by time: comparison of rates of change||||0.06
72394944|NCT00536198|144296394|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.88|STANDARD_ERROR_OF_MEAN|0.95||0.049|TWO_SIDED|95.0|0.01|3.75|||Mixed Models Analysis|||Estimated mean difference from baseline to endpoint between active vs. placebo||3.75|0.01|0.049
72394945|NCT00536198|144296395|SUPERIORITY_OR_OTHER|||||||0.54|TWO_SIDED||||||ANOVA|||Group comparison||||0.54
72394946|NCT00536198|144296395|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANOVA|||Change over time in both groups||||<0.001
72394947|NCT00536198|144296395|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED||||||ANOVA|||Group by time: comparison of rates of change||||0.02
72468990|NCT01663506|144461493|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.01|TWO_SIDED||||||Wilcoxon's signed-rank test|||Change from Baseline at Month 12||||<0.01
72468991|NCT01663506|144461495|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Wilcoxon's signed-rank test|||Change from Baseline at Month 6||||<0.001
72468992|NCT01663506|144461495|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.01|TWO_SIDED||||||Wilcoxon's signed-rank test|||Change from Baseline at Month 12||||<0.01
72468993|NCT01663506|144461496|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05|TWO_SIDED||||||Wilcoxon's signed-rank test|||Change from Baseline at Month 6||||<0.05
72468994|NCT01663506|144461496|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.01|TWO_SIDED||||||Wilcoxon's signed-rank test|||Change from Baseline at Month 12||||<0.01
72468995|NCT01663506|144461498|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.01|TWO_SIDED||||||Wilcoxon's signed-rank test|||SJC28: Change from Baseline at Month 6||||<0.01
72468996|NCT01663506|144461498|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.01|TWO_SIDED||||||Wilcoxon's signed-rank test|||TJC28: Change from Baseline at Month 6||||<0.01
72468997|NCT01663506|144461498|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Wilcoxon's signed-rank test|||SJC28: Change from Baseline at Month 12||||<0.001
72565163|NCT00107042|144661892|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.86||||0.0102|TWO_SIDED|95.0|1.58|29.78|||Univariate regression, logistic||The reference group is the 'Hispanic: NO' group.|||29.78|1.58|0.0102
72394948|NCT00536198|144296395|SUPERIORITY_OR_OTHER||Mean Difference (Net)|5.14|STANDARD_ERROR_OF_MEAN|1.62||0.0015|TWO_SIDED|95.0|1.97|8.31|||Mixed Models Analysis|||Estimated mean difference from baseline to end point between active vs. placebo||8.31|1.97|0.0015
72394949|NCT00536198|144296396|SUPERIORITY_OR_OTHER|||||||0.46|TWO_SIDED||||||ANOVA|||Group comparison||||0.46
72394950|NCT00536198|144296396|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANOVA|||Change over time in both groups||||<0.0001
72394951|NCT00536198|144296396|SUPERIORITY_OR_OTHER|||||||0.69|TWO_SIDED||||||ANOVA|||Group by time: comparison rates of change||||0.69
72394952|NCT00536198|144296396|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.02||||0.84|TWO_SIDED|95.0|0.83|1.26|||Mixed Models Analysis|||Estimated mean difference from Cycle 1 to end point between active vs. placebo||1.26|0.83|0.84
72468998|NCT01663506|144461498|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.01|TWO_SIDED||||||Wilcoxon's signed-rank test|||TJC28: Change from Baseline at Month 12||||<0.01
72468999|NCT01663506|144461499|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.01|TWO_SIDED||||||Wilcoxon's signed-rank test|||Change from Baseline at Month 6||||<0.01
72565164|NCT00107042|144661892|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|7.38||||0.0118|TWO_SIDED|95.0|1.56|34.95||Since Hispanic (no, yes) was a factor with a p-value of \< 0.15 in the unadjusted univariate regression analysis, it was entered into the initial full multivariate model.|Multivariate regression, logistic||"The reference group is the Hispanic: NO group."|||34.95|1.56|0.0118
72622104|NCT04003142|144774324|SUPERIORITY||LSMean difference|-14.78|STANDARD_ERROR_OF_MEAN|3.87|<|0.001||95.0|-22.38|-7.19||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 6||-7.19|-22.38|<0.001
72394953|NCT00536198|144296397|SUPERIORITY_OR_OTHER|||||||0.01|TWO_SIDED||||||Chi-squared|||Group comparison||||0.01
72394954|NCT00536198|144296397|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Chi-squared|||Change over time in both groups||||<0.001
72394955|NCT00536198|144296397|SUPERIORITY_OR_OTHER|||||||0.28|TWO_SIDED||||||Chi-squared|||Group by time: comparison rates of change||||0.28
72394956|NCT00536198|144296397|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.59||||0.056|TWO_SIDED|95.0|0.3|1.19|||Mixed Models Analysis|||Estimated mean difference from baseline to end point between active vs. placebo||1.19|0.30|0.056
72394957|NCT00536198|144296399|SUPERIORITY_OR_OTHER|||||||0.3|TWO_SIDED||||||ANOVA|||Group comparison||||0.30
72394958|NCT00536198|144296399|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||ANOVA|||Change over time in both groups||||<0.01
72394959|NCT00536198|144296399|SUPERIORITY_OR_OTHER|||||||0.73|TWO_SIDED||||||ANOVA|||Group by time: comparison rates of change||||0.73
72394960|NCT00536198|144296399|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.12||||0.06|TWO_SIDED|95.0|0.92|1.35|||Mixed Models Analysis|||Estimated mean difference from baseline to end point between active vs. placebo||1.35|0.92|0.06
72394961|NCT00536198|144296400|SUPERIORITY_OR_OTHER|||||||0.8|TWO_SIDED||||||ANOVA|||Group comparison||||0.80
72394962|NCT00536198|144296400|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANOVA|||Change over time in both groups||||<0.001
72394963|NCT00536198|144296400|SUPERIORITY_OR_OTHER|||||||0.43|TWO_SIDED||||||ANOVA|||Group by time: comparison rates of change||||0.43
72394964|NCT00536198|144296400|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.11||||0.61|TWO_SIDED|95.0|0.85|1.45|||Mixed Models Analysis|||Estimated mean difference from baseline to endpoint between active vs. placebo||1.45|0.85|0.61
72394965|NCT00536198|144296401|SUPERIORITY_OR_OTHER|||||||0.83|TWO_SIDED||||||ANOVA|||Group comparison||||0.83
72394966|NCT00536198|144296401|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANOVA|||Change over time in both groups||||<0.001
72394967|NCT00536198|144296401|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED||||||ANOVA|||Group by time: comparison rates of change||||0.02
72394968|NCT00536198|144296401|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.09||||0.169|TWO_SIDED|95.0|0.96|1.25|||Mixed Models Analysis|||Estimated mean difference from baseline to end point between active vs. placebo||1.25|0.96|0.169
72469000|NCT01663506|144461499|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Wilcoxon's signed-rank test|||Change from Baseline at Month 12||||<0.001
72469001|NCT01663506|144461500|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.01|TWO_SIDED||||||Wilcoxon's signed-rank test|||Change from Baseline at Month 6||||<0.01
72469002|NCT01663506|144461500|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Wilcoxon's signed-rank test|||Change from Baseline at Month 12||||<0.001
72565165|NCT00107042|144661893|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.4||||0.4241|TWO_SIDED|95.0|0.04|3.84|||Univariate regression, logistic||The reference group is the 'White' group.|||3.84|0.04|0.4241
72565166|NCT00107042|144661893|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.12||||0.2685|TWO_SIDED|95.0|0.34|50.76|||Univariate regression, logistic||The reference group is the 'White' group.|||50.76|0.34|0.2685
72565167|NCT00107042|144661894|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.89||||0.939|TWO_SIDED|95.0|0.05|15.44|||Univariate regression, logistic||The reference group is the 'Stage 5' group.|||15.44|0.05|0.9390
72565168|NCT00107042|144661895|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.5||||0.6181|TWO_SIDED|95.0|0.3|7.39|||Univariate regression, logistic||"The reference group is the Stage 5 group."|||7.39|0.30|0.6181
72565169|NCT00107042|144661896|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.4||||0.1943|TWO_SIDED|95.0|0.1|1.6|||Univariate regression, logistic||"The reference group is the Normal and Underweight (\<25.0) group."|||1.60|0.10|0.1943
72565170|NCT00107042|144661897|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.42||||0.2542|TWO_SIDED|95.0|0.1|1.86|||Univariate regression, logistic||"The reference group is the Ever smoked cigarettes: NO group."|||1.86|0.10|0.2542
72565171|NCT00107042|144661898|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.14||||0.0161|TWO_SIDED|95.0|0.03|0.69|||Univariate regression, logistic||"The reference group is the Straight (heterosexual) group."|||0.69|0.03|0.0161
72394969|NCT00536198|144296402|SUPERIORITY_OR_OTHER|||||||0.37|TWO_SIDED||||||ANOVA|||Group comparison||||0.37
72394970|NCT00536198|144296402|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANOVA|||Change over time in both groups||||<0.001
72394971|NCT00536198|144296402|SUPERIORITY_OR_OTHER|||||||0.73|TWO_SIDED||||||ANOVA|||Group by time: comparison rates of change||||0.73
72394972|NCT00536198|144296402|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.08||||0.13|TWO_SIDED|95.0|0.91|1.28|||Mixed Models Analysis|||Estimated mean difference from baseline to end point between active vs. placebo||1.28|0.91|0.13
72394973|NCT00536198|144296403|SUPERIORITY_OR_OTHER|||||||0.31|TWO_SIDED||||||ANOVA|||Group comparison||||0.31
72469003|NCT02270671|144461517|SUPERIORITY_OR_OTHER||||||>|0.05||||||Group x Time interaction p-value: \>.05; Gender p-value: \>.05|ANOVA|2x2x3 repeated measures ANOVA. 2 between-subjects factors (Group; Gender) and 1 within-subject factor (Time). P value adjusted to p \< .025.||||||>.05
72469004|NCT02270671|144461518|SUPERIORITY_OR_OTHER||||||>|0.05||||||Group x Time interaction p-value: \>.05; Gender p-value: =.026|ANOVA|2x2x3 repeated measures ANOVA. 2 between-subjects factors (Group; Gender) and 1 within-subject factor (Time). P value adjusted to p \< .025.||||||>.05
72469005|NCT02270671|144461519|SUPERIORITY_OR_OTHER||||||>|0.05||||||Group x Time interaction p-value: \>.05; Gender p-value: \>.05|ANOVA|2x2x3 repeated measures ANOVA. 2 between-subjects factors (Group; Gender) and 1 within-subject factor (Time). P value adjusted to p \< .025.||||||>.05
72565172|NCT00107042|144661898|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.12||||0.0222|TWO_SIDED|95.0|0.02|0.74||Since sexual identity was a factor with a p-value of \< 0.15 in the unadjusted univariate regression analysis, it was entered into the initial full multivariate model.|Multivariate regression, logistic||"The reference group is the Straight (heterosexual) group."|||0.74|0.02|0.0222
72394974|NCT00536198|144296403|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANOVA|||Change over time in both groups||||<0.001
72394975|NCT00536198|144296403|SUPERIORITY_OR_OTHER|||||||0.46|TWO_SIDED||||||ANOVA|||Group by time: comparison rates of change||||0.46
72394976|NCT00536198|144296403|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.09||||0.94|TWO_SIDED|95.0|0.96|1.23|||Mixed Models Analysis|||Estimated mean difference from baseline to end point between active vs. placebo||1.23|0.96|0.94
72394977|NCT00536198|144296404|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANOVA|||Group comparison||||<0.001
72394978|NCT00536198|144296404|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANOVA|||Change over time in both groups||||<0.001
72394979|NCT00536198|144296404|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||ANOVA|||Group by time: comparison rates of change||||<0.01
72469006|NCT02270671|144461520|SUPERIORITY_OR_OTHER||||||>|0.05||||||Group x Time interaction p-value: \>.05; Gender p-value: \<.0001|ANOVA|2x2x3 repeated measures ANOVA. 2 between-subjects factors (Group; Gender) and 1 within-subject factor (Time). P value adjusted to p \< .025.||||||>.05
72469007|NCT02270671|144461521|SUPERIORITY_OR_OTHER||||||>|0.05||||||Group x Time interaction p-value: \>.05; Gender p-value: =.007|ANOVA|2x2x3 repeated measures ANOVA. 2 between-subjects factors (Group; Gender) and 1 within-subject factor (Time). P value adjusted to p \< .025.||||||>.05
72469008|NCT00476242|144461523|SUPERIORITY_OR_OTHER|||||||0.047|||||||Log Rank|||||||.047
72394980|NCT00536198|144296404|SUPERIORITY_OR_OTHER||Median Difference (Net)|1.22||||0.027|TWO_SIDED|95.0|1.05|1.41|||Mixed Models Analysis|||Estimated mean difference from baseline to end point between active vs. placebo||1.41|1.05|0.027
72394981|NCT00536198|144296405|SUPERIORITY_OR_OTHER|||||||0.01|TWO_SIDED||||||Chi-squared|||Group comparison||||0.01
72394982|NCT00536198|144296405|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Chi-squared|||Group by time: comparison rates of change||||<0.001
72394983|NCT00536198|144296405|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.55||||0.056|TWO_SIDED|95.0|0.3|1.02|||Mixed Models Analysis|||Estimated mean difference between active and placebo groups at end-point only||1.02|0.30|0.056
72394984|NCT00923247|144296437|SUPERIORITY_OR_OTHER|||||||0.019|||||||Mann-Whitney|(nonparametric unpaired t-test; assumed homoscedasticity)||Patients given bortezomib on cycle 1, day 1 vs. cycle 3, day 1. A paired analysis among same 14 patients on Phase 1 portion. To assess whether presence of vandetanib significantly altered bortezomib Cmax (normalized to dose).||||0.019
72394985|NCT00923247|144296438|SUPERIORITY_OR_OTHER|||||||0.052|||||||Mann-Whitney|(nonparametric unpaired t-test; assumed homoscedasticity)||Patients given bortezomib on cycle 1 day 1 vs. cycle 3 day 1. A paired analysis among same 14 patients on Phase 1 portion. To assess whether presence of vandetanib significantly altered bortezomib AUCinf (normalized to dose).||||0.052
72394986|NCT00923247|144296439|SUPERIORITY_OR_OTHER|||||||0.44|||||||Mann-Whitney|(nonparametric unpaired t-test; assumed homoscedasticity)||Patients given bortezomib on cycle 1 day 1 vs. cycle 3 day 1. A paired analysis among same 14 patients on Phase 1 portion. To assess whether presence of vandetanib significantly altered bortezomib half-life.||||0.440
72469009|NCT05878873|144461562|OTHER||Mean Difference (Net)|-0.078|STANDARD_ERROR_OF_MEAN|0.027||0.007|TWO_SIDED|||||This value was adjusted using false discovery rate.|Mixed Models Analysis|Degrees of freedom = 44.|This estimate calculation is TENS ON - TENS OFF.|Statistical analysis comparing cortical activation between TENS ON and TENS OFF conditions in people with multiple sclerosis.||||0.007
72469010|NCT05878873|144461562|OTHER||Mean Difference (Net)|-0.089|STANDARD_ERROR_OF_MEAN|0.032||0.008|TWO_SIDED|||||This value was adjusted using false discovery rate.|Mixed Models Analysis|Degrees of freedom = 44|The estimate calculation is TENS ON - TENS OFF.|Statistical analysis comparing cortical activation between TENS ON and TENS OFF conditions in healthy controls.||||0.008
72469011|NCT05878873|144461563|OTHER||Mean Difference (Net)|0.042|STANDARD_ERROR_OF_MEAN|0.0141||0.014|TWO_SIDED|||||This value was adjusted using false discovery rate.|Mixed Models Analysis|Degrees of freedom = 44|This estimate calculation is TENS ON - TENS OFF at Visit 2.|Statistical analysis comparing savings between TENS ON and TENS OFF conditions in people with multiple sclerosis.||||0.014
72565173|NCT00107042|144661899|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.17||||0.8945|TWO_SIDED|95.0|0.12|11.83|||Univariate regression, logistic||"The reference group is the Never (had sex)group."|||11.83|0.12|0.8945
72565174|NCT00107042|144661899|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.12||||0.019|TWO_SIDED|95.0|0.02|0.7|||Univariate regression, logistic||"The reference group is the Never (had sex) group."|||0.70|0.02|0.0190
72565175|NCT00107042|144661900|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.08||||0.0042|TWO_SIDED|95.0|0.01|0.48|||Univariate regression, logistic||"The reference group is the 0 partners group"|||0.48|0.01|0.0042
72565176|NCT00107042|144661900|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.65||||0.6893||95.0|||||Univariate regression, Logistic||"The reference group is the 0 partners group.~Two sided 95% confidence interval: Lower Limit = 0.17; upper limit = infinity"|||||0.6893
72504328|NCT02723630|144539231|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean Ratio|99.68||||0.9427|TWO_SIDED|90.0|92.45|107.47||P value for formulation|Mixed Models Analysis||Geometric LS Mean ratio was back-transformed least squares mean and treatment difference mean|The effect of crystalline polymorph forms in the drug product on the PK parameters of lenvatinib was estimated using a mixed linear model of logarithmically transformed values of the primary PK parameters with fixed effects for treatment, period, and sequence and a random effect for participant within sequence.||107.47|92.45|0.9427
72565177|NCT00107042|144661901|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.015||||0.0003|TWO_SIDED|95.0|0.0|0.19|||Univariate regression, logistic||"The reference group is hte 0 Partners group."|||0.19|0.00|0.0003
72565178|NCT00107042|144661901|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.18||||1|TWO_SIDED|95.0|0.0|10.01|||Univariate regression, Logistic||"The reference group is the 0 Partners group"|||10.01|0.00|1.0000
72565179|NCT00107042|144661902|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.5||||0.5503|TWO_SIDED|95.0|0.05|4.86|||Univariate regression, logistic||"The reference group is the 0 Partners group"|||4.86|0.05|0.5503
72565180|NCT00107042|144661902|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.17||||0.8904|TWO_SIDED|95.0|0.13|10.46|||Univariate Regression, Logistic||"The reference group is the 0 Partners group."|||10.46|0.13|0.8904
72565181|NCT00107042|144661903|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.48||||0.301|TWO_SIDED|95.0|0.12|1.92|||Univariate regression, logistic||"The reference group is the Ever drank alcohol: NO group."|||1.92|0.12|0.3010
72565182|NCT00107042|144661904|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.24||||0.0501|TWO_SIDED|95.0|0.06|1.0|||Univariate regression, logistic||"The reference group is the Ever smoked marijuana: NO group."|||1.00|0.06|0.0501
72565183|NCT00107042|144661905|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.36||||0.3846|TWO_SIDED|95.0|0.04|3.61|||Univariate regression, logistic||"The reference group is the Ever used drugs not prescribed: NO group."|||3.61|0.04|0.3846
72565184|NCT00107042|144661906|SUPERIORITY_OR_OTHER|||||||0.3827||95.0|||||Fisher Exact|||||||0.3827
72565185|NCT00107042|144661906|SUPERIORITY_OR_OTHER||Responding Rate|81.08|||||TWO_SIDED|95.0|68.84|92.04|||||Response rate=Total number subjects responded/Total number subjects in arm|||92.04|68.84|
72565186|NCT00107042|144661906|SUPERIORITY_OR_OTHER||Responding Rate|88.0|||||TWO_SIDED|95.0|75.69|95.47|||||Response rate=Total number subjects responded/Total number subjects in arm|||95.47|75.69|
72565187|NCT00107042|144661907|SUPERIORITY_OR_OTHER||Responding rate|98.08|||||TWO_SIDED|95.0|89.74|99.95||A p-value has not been entered because there is only one study arm in this analysis.|Exact 95% CI|||||99.95|89.74|
72622105|NCT04003142|144774324|SUPERIORITY||LSMean difference|-22.66|STANDARD_ERROR_OF_MEAN|3.86|<|0.001|TWO_SIDED|95.0|-30.25|-15.07||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 6||-15.07|-30.25|<0.001
72622106|NCT04003142|144774324|SUPERIORITY||LSMean difference|-14.97|STANDARD_ERROR_OF_MEAN|4.01|<|0.001|TWO_SIDED|95.0|-22.86|-7.09||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 7||-7.09|-22.86|<0.001
72622107|NCT04003142|144774324|SUPERIORITY||LSMean difference|-21.47|STANDARD_ERROR_OF_MEAN|4.01|<|0.001||95.0|-29.34|-13.6||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 7||-13.60|-29.34|<0.001
72622108|NCT04003142|144774324|SUPERIORITY||LSMean difference|-14.38|STANDARD_ERROR_OF_MEAN|4.05|<|0.001|TWO_SIDED|95.0|-22.33|-6.43||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 8||-6.43|-22.33|<0.001
72565188|NCT00107042|144661908|SUPERIORITY_OR_OTHER||Responding Rate|91.49||||||95.0|79.62|97.63||A p-value has not been entered because there is only one study arm in this analysis.|Exact 95 % confidence interval|||||97.63|79.62|
72565189|NCT00107042|144661909|SUPERIORITY_OR_OTHER||Responding Rate %|98.11|||||TWO_SIDED|95.0|89.93|99.95||A p-value has not been entered because there is only one study arm in this analysis.|Exact 95% confidence interval||"For overall response, if a subject is reactive at either 1-month or 12-month, then the overall response is considered Positive. If a subject is non-reactive at both 1-month and 12-month, then the overall response for this subject is Negative."|||99.95|89.93|
72565190|NCT00107042|144661910|SUPERIORITY_OR_OTHER|||||||0.2938||95.0|||||Fisher Exact|||||||0.2938
72565191|NCT00107042|144661910|SUPERIORITY_OR_OTHER||Responding Rate %|85.37|||||TWO_SIDED|95.0|70.83|94.43|||95 % confidence interval|||||94.43|70.83|
72565192|NCT00107042|144661910|SUPERIORITY_OR_OTHER||Responding Rate %|93.62|||||TWO_SIDED|95.0|82.46|98.66|||95% confidence interval|||||98.66|82.46|
72565193|NCT01221090|144661913|SUPERIORITY_OR_OTHER|||||||0.771||95.0||||A priori threshold for statistical significance is \<0.05|Likelihood Ratio Tests|||We used a multilevel statistical model including time (in days) as a continuous variable, where 0=baseline. The lowest level of the hierarchy was repeated measurements of HbA1c on each subject, with participants themselves constituting the 2nd level. Forward selection was utilized, in which powers of time were added one at a time to the base model including treatment group effects. Interaction terms between time \& treatment effects were added gradually and evaluated with likelihood ratio tests.||||0.771
72565194|NCT01221090|144661914|SUPERIORITY_OR_OTHER|||||||0.2176||95.0||||A priori threshold for statistical significance is \<0.05|Regression, Linear|Robust variance estimates.||||||0.2176
72565195|NCT01221090|144661915|SUPERIORITY_OR_OTHER|||||||0.572||95.0||||A priori threshold for statistical significance was \<0.05|Fisher Exact|||||||0.572
72565196|NCT01221090|144661916|SUPERIORITY_OR_OTHER|||||||0.26||95.0||||A priori threshold for statistical significance is \<0.05|ANOVA|||"This analysis was to compare the average difference in days for the diabetes self-care activity, Test blood sugar."||||0.26
72469012|NCT05878873|144461563|OTHER||Mean Difference (Net)|-0.0058|STANDARD_ERROR_OF_MEAN|0.167||0.878|TWO_SIDED|||||This value was corrected with false discovery rate.|Mixed Models Analysis|Degrees of freedom = 44|The estimate calculation is TENS ON - TENS OFF at Visit 2|Statistical analysis comparing savings between TENS ON and TENS OFF conditions in healthy controls.||||0.878
72469013|NCT05878873|144461564|OTHER||Mean Difference (Final Values)|0.002|STANDARD_ERROR_OF_MEAN|0.018||0.898|TWO_SIDED|||||This value was corrected using false discovery rate.|Mixed Models Analysis|Degrees of freedom = 44|The estimate calculation is TENS ON - TENS OFF|Statistical analysis comparing rate of adaptation between TENS ON and TENS OFF conditions in people with multiple sclerosis.||||0.898
72469014|NCT05878873|144461564|OTHER||Mean Difference (Final Values)|-0.008|STANDARD_ERROR_OF_MEAN|0.021||0.698|TWO_SIDED|||||This value was corrected using false discovery rate.|Mixed Models Analysis|Degrees of freedom = 44|The estimate calculation is TENS ON - TENS OFF|Statistical analysis comparing rate of adaptation between TENS ON and TENS OFF conditions in healthy controls.||||0.698
72469015|NCT03865953|144461574|SUPERIORITY|Analysis used a two-period two-treatment crossover design|Mean Difference (Net)|-0.14||||0.67|TWO_SIDED|95.0|-0.76|0.49|||Mixed Models Analysis|||Subject numbers gave a 90% power to demonstrate a statistically significant difference in the mean change from baseline NPRS for the active treatment compared with placebo of at least 1 unit, with a two sided test at a 5% level of significance||0.49|-0.76|0.67
72469016|NCT00882115|144461589|OTHER||||||<|0.001|||||||ANOVA|Data followed the normal distribution, therefore, a parametric repeated measure (mixed model) ANOVA model was used to compare means.||Comparison was made to the 24 h minus baseline change in both control phase and intervention phase.||||<0.001
72469017|NCT00882115|144461589|OTHER||||||<|0.01|||||||ANOVA|Data followed the normal distribution, therefore, a parametric repeated measure (mixed model) ANOVA model was used to compare means.||Comparison waws made to the 6 hour minus baseline change in both control phase and intervention phase.||||<0.01
72469018|NCT00745498|144461635|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Chi-squared|||With study power of 80%, a significance level of 0.05, and the assumption that IVB injection will decrease postoperative VH incidence from 35% to 10%, a sample size of 40 patients for each group was calculated.||||<0.05
72469019|NCT02353871|144461658|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Statistical tests were two-sided with a type I error rate at 5%.|Regression, Logistic|Multivariate model, controlling for centre and stratification factors (i.e. gender and baseline ILA (maximum frown)) as fixed effects.||Comparison of ILA - BTX-A-HAC NG solution (50 U) versus Placebo at Day 29||||<0.0001
72469020|NCT02353871|144461659|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Statistical tests were two-sided with a type I error rate at 5%.|Regression, Logistic|Multivariate model, controlling for centre and stratification factors (i.e. gender and baseline ILA (maximum frown)) as fixed effects.||Comparison of ILA at Day 8 - BTX-A-HAC NG solution (50 U) versus placebo||||<0.0001
72469021|NCT02353871|144461659|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Statistical tests were two-sided with a type I error rate at 5%.|Regression, Logistic|Multivariate model, controlling for centre and stratification factors (i.e. gender and baseline ILA (maximum frown)) as fixed effects.||Comparison of ILA at Day 15 - BTX-A-HAC NG solution (50 U) versus placebo||||<0.0001
72469022|NCT02353871|144461659|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Statistical tests were two-sided with a type I error rate at 5%.|Regression, Logistic|Multivariate model, controlling for centre and stratification factors (i.e. gender and baseline ILA (maximum frown)) as fixed effects.||Comparison of ILA at Day 57 - BTX-A-HAC NG solution (50 U) versus placebo||||<0.0001
72469023|NCT02353871|144461659|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Statistical tests were two-sided with a type I error rate at 5%.|Regression, Logistic|Multivariate model, controlling for centre and stratification factors (i.e. gender and baseline ILA (maximum frown)) as fixed effects.||Comparison of ILA at Day 85 - BTX-A-HAC NG solution (50 U) versus placebo||||<0.0001
72469024|NCT02353871|144461659|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Statistical tests were two-sided with a type I error rate at 5%.|Regression, Logistic|Multivariate model, controlling for centre and stratification factors (i.e. gender and baseline ILA (maximum frown)) as fixed effects.||Comparison of ILA at Day 113 - BTX-A-HAC NG solution (50 U) versus placebo||||<0.0001
72565197|NCT01221090|144661916|SUPERIORITY_OR_OTHER|||||||0.21||95.0||||A priori threshold for statistical significance is \<0.05|ANOVA|||"This analysis was to compare the average difference in days for the diabetes self-care activity, Test blood sugar the recommended times."||||0.21
72622109|NCT04003142|144774324|SUPERIORITY||LSMean difference|-20.57|STANDARD_ERROR_OF_MEAN|4.03|<|0.001||95.0|-28.5|-12.65||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 8||-12.65|-28.50|<0.001
72469025|NCT02353871|144461659|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0035||||||Statistical tests were two-sided with a type I error rate at 5%.|Regression, Logistic|Multivariate model, controlling for centre and stratification factors (i.e. gender and baseline ILA (maximum frown)) as fixed effects.||Comparison of ILA at Day 148 - BTX-A-HAC NG solution (50 U) versus placebo||||0.0035
72469026|NCT02353871|144461659|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0441||||||Statistical tests were two-sided with a type I error rate at 5%.|Regression, Logistic|Multivariate model, controlling for centre and stratification factors (i.e. gender and baseline ILA (maximum frown)) as fixed effects.||Comparison of ILA at Day 183 (End of Study) - BTX-A-HAC NG solution (50 U) versus placebo||||0.0441
72469027|NCT02353871|144461660|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2422||||||Statistical tests were two-sided with a type I error rate at 5%.|Regression, Logistic|Multivariate model, controlling for centre and stratification factors (i.e. gender and baseline ILA (maximum frown)) as fixed effects.||Comparison of the proportion of responders on Day 29 who remained responders at Day 57 - BTX-A-HAC NG solution (50 U) versus Placebo||||0.2422
72565198|NCT01221090|144661916|SUPERIORITY_OR_OTHER|||||||0.53||95.0||||A priori threshold for statistical significance is \<0.05|ANOVA|||"This analysis was to compare the average difference in days for the diabetes self-care activity, Exercise at least 30 minutes."||||0.53
72565199|NCT01221090|144661916|SUPERIORITY_OR_OTHER|||||||0.24||95.0||||A priori threshold for statistical significance is \<0.05|ANOVA|||"This analysis was to compare the average difference in days for the diabetes self-care activity, Participate in a specific exercise session."||||0.24
72565200|NCT01221090|144661916|SUPERIORITY_OR_OTHER|||||||0.18||95.0||||A priori threshold for statistical significance is \<0.05|ANOVA|||"This analysis was to compare the average difference in days for the diabetes self-care activity, Check feet."||||0.18
72565201|NCT01221090|144661916|SUPERIORITY_OR_OTHER|||||||0.19||95.0||||A priori threshold for statistical significance is \<0.05|ANOVA|||"This analysis was to compare the average difference in days for the diabetes self-care activity, Wash feet."||||0.19
72469028|NCT02353871|144461660|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0917||||||Statistical tests were two-sided with a type I error rate at 5%.|Regression, Logistic|Multivariate model, controlling for centre and stratification factors (i.e. gender and baseline ILA (maximum frown)) as fixed effects.||Comparison of the proportion of responders on Day 29 who remained responders at Day 85 - BTX-A-HAC NG solution (50 U) versus Placebo||||0.0917
72469029|NCT02353871|144461660|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7064||||||Statistical tests were two-sided with a type I error rate at 5%.|Regression, Logistic|Multivariate model, controlling for centre and stratification factors (i.e. gender and baseline ILA (maximum frown)) as fixed effects.||Comparison of the proportion of responders on Day 29 who remained responders at Day 113 - BTX-A-HAC NG solution (50 U) versus Placebo||||0.7064
72469030|NCT02353871|144461660|SUPERIORITY_OR_OTHER_LEGACY|||||||0.701||||||Statistical tests were two-sided with a type I error rate at 5%.|Regression, Logistic|Multivariate model, controlling for centre and stratification factors (i.e. gender and baseline ILA (maximum frown)) as fixed effects.||Comparison of the proportion of responders on Day 29 who remained responders at Day 148 - BTX-A-HAC NG solution (50 U) versus Placebo||||0.7010
72469031|NCT02353871|144461660|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7894||||||Statistical tests were two-sided with a type I error rate at 5%.|Regression, Logistic|Multivariate model, controlling for centre and stratification factors (i.e. gender and baseline ILA (maximum frown)) as fixed effects.||Comparison of the proportion of responders on Day 29 who remained responders at Day 183 - BTX-A-HAC NG solution (50 U) versus Placebo||||0.7894
72469032|NCT02353871|144461661|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Statistical tests were two-sided with a type I error rate at 5%.|Regression, Logistic|Multivariate model, controlling for centre and stratification factors (i.e. gender and baseline ILA (at rest)) as fixed effects.||Comparison of ILA - BTX-A-HAC NG solution (50 U) versus Placebo at Day 8||||<0.0001
72469033|NCT02353871|144461661|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Statistical tests were two-sided with a type I error rate at 5%.|Regression, Logistic|Multivariate model, controlling for centre and stratification factors (i.e. gender and baseline ILA (at rest)) as fixed effects.||Comparison of ILA - BTX-A-HAC NG solution (50 U) versus Placebo at Day 15||||<0.0001
72469034|NCT02353871|144461661|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Statistical tests were two-sided with a type I error rate at 5%.|Regression, Logistic|Multivariate model, controlling for centre and stratification factors (i.e. gender and baseline ILA (at rest)) as fixed effects.||Comparison of ILA - BTX-A-HAC NG solution (50 U) versus Placebo at Day 29||||<0.0001
72469035|NCT02353871|144461661|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Statistical tests were two-sided with a type I error rate at 5%.|Regression, Logistic|Multivariate model, controlling for centre and stratification factors (i.e. gender and baseline ILA (at rest)) as fixed effects.||Comparison of ILA - BTX-A-HAC NG solution (50 U) versus Placebo at Day 57||||<0.0001
72469036|NCT02353871|144461661|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Statistical tests were two-sided with a type I error rate at 5%.|Regression, Logistic|Multivariate model, controlling for centre and stratification factors (i.e. gender and baseline ILA (at rest)) as fixed effects.||Comparison of ILA - BTX-A-HAC NG solution (50 U) versus Placebo at Day 85||||<0.0001
72469037|NCT02353871|144461661|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Statistical tests were two-sided with a type I error rate at 5%.|Regression, Logistic|Multivariate model, controlling for centre and stratification factors (i.e. gender and baseline ILA (at rest)) as fixed effects.||Comparison of ILA - BTX-A-HAC NG solution (50 U) versus Placebo at Day 113||||<0.0001
72469038|NCT02353871|144461661|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0015||||||Statistical tests were two-sided with a type I error rate at 5%.|Regression, Logistic|Multivariate model, controlling for centre and stratification factors (i.e. gender and baseline ILA (at rest)) as fixed effects.||Comparison of ILA - BTX-A-HAC NG solution (50 U) versus Placebo at Day 183||||0.0015
72469039|NCT02353871|144461662|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Statistical tests were two-sided with a type I error rate at 5%.|Regression, Logistic|Multivariate model, controlling for centre and stratification factors (i.e. gender and baseline ILA (maximum frown)) as fixed effects.||Comparison of ILA - BTX-A-HAC NG solution (50 U) versus Placebo at Day 8||||<0.0001
72565202|NCT01221090|144661916|SUPERIORITY_OR_OTHER|||||||0.87||95.0||||A priori threshold for statistical significance is \<0.05|ANOVA|||"This analysis was to compare the average difference in days for the diabetes self-care activity, Soak feet."||||0.87
72565203|NCT01221090|144661916|SUPERIORITY_OR_OTHER|||||||0.53||95.0||||A priori threshold for statistical significance is \<0.05|ANOVA|||"This analysis was to compare the average difference in days for the diabetes self-care activity, Dry between toes."||||0.53
72565204|NCT01221090|144661916|SUPERIORITY_OR_OTHER|||||||0.32||95.0||||A priori threshold for statistical significance is \<0.05|ANOVA|||"This analysis was to compare the average difference in days for the diabetes self-care activity, Inspect inside of shoes."||||0.32
72565205|NCT01221090|144661916|SUPERIORITY_OR_OTHER|||||||0.37||95.0||||A priori threshold for statistical significance is \<0.05|ANOVA|||"This analysis was to compare the average difference in days for the diabetes self-care activity, Follow healthful eating plan."||||0.37
72565206|NCT01221090|144661916|SUPERIORITY_OR_OTHER|||||||0.72||95.0||||A priori threshold for statistical significance is \<0.05|ANOVA|||"This analysis was to compare the average difference in days for the diabetes self-care activity, Space carbohydrates."||||0.72
72565207|NCT01221090|144661916|SUPERIORITY_OR_OTHER|||||||0.59||95.0||||A priori threshold for statistical significance is \<0.05|ANOVA|||"This analysis was to compare the average difference in days for the diabetes self-care activity, Eat 5+ servings of fruits and vegetables."||||0.59
72565208|NCT01221090|144661916|SUPERIORITY_OR_OTHER||||||<|0.004||95.0||||A priori threshold for statistical significance is \<0.05|ANOVA|||"This analysis was to compare the average difference in days for the diabetes self-care activity, Eat high-fat foods."||||<0.004
72565209|NCT01221090|144661916|SUPERIORITY_OR_OTHER|||||||0.66||95.0||||A priori threshold for statistical significance is \<0.05|ANOVA|||"This analysis was to compare the average difference in days for the diabetes self-care activity, Eat packaged foods (e.g., sweets and desserts)."||||0.66
72565210|NCT01221090|144661916|SUPERIORITY_OR_OTHER|||||||0.68||95.0||||A priori threshold for statistical significance is \<0.05|ANOVA|||"This analysis was to compare the average difference in days for the diabetes self-care activity, Followed a healthful eating plan."||||0.68
72565211|NCT01221090|144661917|SUPERIORITY_OR_OTHER|||||||0.685||95.0||||A priori threshold for statistical significance is \<0.05|Regression, Linear|Robust Variance Estimation.||"This analysis was to compare the quality of life measure, Number of days physical health was not good in the past 30 days at the 12 month follow-up visit."||||0.685
72565212|NCT01221090|144661917|SUPERIORITY_OR_OTHER|||||||0.997||95.0||||A priori threshold for statistical significance is \<0.05|Regression, Linear|Robust variance estimation.||"This analysis was to compare the quality of life measure, Number of days mental health was not good in the past 30 days at the 12 month follow-up visit."||||0.997
72565213|NCT01221090|144661917|SUPERIORITY_OR_OTHER|||||||0.3067||95.0||||A priori threshold for statistical significance is \<0.05|Regression, Linear|Robust variance estimation.||"This analysis was to compare the quality of life measure, Number of days poor physical/mental health prevented usual activity in the past 30 days at the 12 month follow-up visit."||||0.3067
72565214|NCT02597582|144661976|NON_INFERIORITY_OR_EQUIVALENCE|"A previous study found that the mean operation time was 165 minutes for patients undergoing LigaSure vessel sealing system-assisted total laryngectomy plus neck dissection and 195 minutes for those receiving conventional hemostasis.~With a difference in operative duration of 30 minutes between the two groups,9 the estimated sample size needed to demonstrate a two-sided significance level of 0.05 with 80% power should be at least 18 participants in each treatment arm."||||||0.022|||||||t-test, 2 sided|||||||0.022
72565215|NCT02597582|144661977|NON_INFERIORITY_OR_EQUIVALENCE|As above||||||0.266|||||||t-test, 2 sided|||||||0.266
72565216|NCT02597582|144661978|NON_INFERIORITY_OR_EQUIVALENCE|as above||||||0.06|||||||t-test, 2 sided|||||||0.060
72565217|NCT02597582|144661980|NON_INFERIORITY_OR_EQUIVALENCE|as above||||||0.524|||||||t-test, 2 sided|||||||0.524
72565218|NCT02597582|144661981|NON_INFERIORITY_OR_EQUIVALENCE|as above||||||0.037|||||||Wilcoxon (Mann-Whitney)|||||||0.037
72565219|NCT02790034|144661996|SUPERIORITY||Mean Difference (Final Values)|-5.292|STANDARD_ERROR_OF_MEAN|11.3184||0.6411|TWO_SIDED|95.0|-27.741|17.157|||Mixed Models Analysis|||Primary inferential comparison between treatment groups used a restricted maximum likelihood (REML)-based, mixed-effects repeated measures model approach (MMRM) with 95% CI for the difference between treatment groups for % change from baseline in the number of apnea episodes. Model included % change from baseline as response, the fixed, categorical effects of treatment group, visit, treatment group-by-visit interaction, and the continuous terms age and baseline value as covariate.||17.157|-27.741|0.6411
72565220|NCT02790034|144661996|SUPERIORITY||Mean Difference (Final Values)|-16.966|STANDARD_ERROR_OF_MEAN|13.1869||0.2011|TWO_SIDED|95.0|-43.119|9.186|||Mixed Models Analysis|||Primary inferential comparison between treatment groups used a restricted maximum likelihood (REML)-based, mixed-effects repeated measures model approach (MMRM) with 95% CI for the difference between treatment groups for % change from baseline in the number of apnea episodes. Model included % change from baseline as response, the fixed, categorical effects of treatment group, visit, treatment group-by-visit interaction, and the continuous terms age and baseline value as covariate.||9.186|-43.119|0.2011
72565221|NCT03440424|144662003|OTHER||Percent ratio of geometric mean|157.86|||||TWO_SIDED|90.0|118.18|210.87|||||Percent ratio of geometric mean was calculated by dividing the geometric mean of test by geometric mean of reference, then multiplying the value by 100.|||210.87|118.18|
72565222|NCT03440424|144662003|OTHER||Percent ratio of geometric mean|122.2|||||TWO_SIDED|90.0|91.49|163.24|||||Percent ratio of geometric mean was calculated by dividing the geometric mean of test by geometric mean of reference, then multiplying the value by 100.|||163.24|91.49|
72565223|NCT03440424|144662004|OTHER||Percent ratio of geometric mean|122.31|||||TWO_SIDED|90.0|98.95|151.17|||||Percent ratio of geometric mean was calculated by dividing the geometric mean of test by geometric mean of reference, then multiplying the value by 100.|||151.17|98.95|
72565224|NCT03440424|144662004|OTHER||Percent ratio of geometric mean|103.24|||||TWO_SIDED|90.0|83.53|127.61|||||Percent ratio of geometric mean was calculated by dividing the geometric mean of test by geometric mean of reference, then multiplying the value by 100.|||127.61|83.53|
72565225|NCT03440424|144662005|OTHER||Percent ratio of geometric mean|125.26|||||TWO_SIDED|90.0|96.76|162.16|||||Percent ratio of geometric mean was calculated by dividing the geometric mean of test by geometric mean of reference, then multiplying the value by 100.|||162.16|96.76|
72565226|NCT03440424|144662005|OTHER||Percent ratio of geometric mean|115.2|||||TWO_SIDED|90.0|88.98|149.13|||||Percent ratio of geometric mean was calculated by dividing the geometric mean of test by geometric mean of reference, then multiplying the value by 100.|||149.13|88.98|
72565227|NCT03440424|144662006|OTHER||Percent ratio of geometric mean|131.91|||||TWO_SIDED|90.0|96.46|180.4|||||Percent ratio of geometric mean was calculated by dividing the geometric mean of test by geometric mean of reference, then multiplying the value by 100.|||180.40|96.46|
72565228|NCT03440424|144662006|OTHER||Percent ratio of geometric mean|149.52|||||TWO_SIDED|90.0|109.34|204.47|||||Percent ratio of geometric mean was calculated by dividing the geometric mean of test by geometric mean of reference, then multiplying the value by 100.|||204.47|109.34|
72565229|NCT03440424|144662007|OTHER||Percent ratio of geometric mean|125.03|||||TWO_SIDED|90.0|87.96|177.74|||||Percent ratio of geometric mean was calculated by dividing the geometric mean of test by geometric mean of reference, then multiplying the value by 100.|||177.74|87.96|
72565230|NCT03440424|144662007|OTHER||Percent ratio of geometric mean|153.56|||||TWO_SIDED|90.0|106.39|221.66|||||Percent ratio of geometric mean was calculated by dividing the geometric mean of test by geometric mean of reference, then multiplying the value by 100.|||221.66|106.39|
72565231|NCT03440424|144662008|OTHER||Percent ratio of geometric mean|128.88|||||TWO_SIDED|90.0|88.35|188.02|||||Percent ratio of geometric mean was calculated by dividing the geometric mean of test by geometric mean of reference, then multiplying the value by 100.|||188.02|88.35|
72565232|NCT03440424|144662008|OTHER||Percent ratio of geometric mean|166.55|||||TWO_SIDED|90.0|112.31|246.99|||||Percent ratio of geometric mean was calculated by dividing the geometric mean of test by geometric mean of reference, then multiplying the value by 100.|||246.99|112.31|
72565233|NCT03440424|144662009|OTHER||Percent ratio of geometric mean|96.97|||||TWO_SIDED|90.0|70.15|134.06|||||Percent ratio of geometric mean was calculated by dividing the geometric mean of test by geometric mean of reference, then multiplying the value by 100.|M4 metabolite||134.06|70.15|
72565234|NCT03440424|144662009|OTHER||Percent ratio of geometric mean|72.05|||||TWO_SIDED|90.0|52.12|99.6|||||Percent ratio of geometric mean was calculated by dividing the geometric mean of test by geometric mean of reference, then multiplying the value by 100.|M4 metabolite||99.60|52.12|
72622110|NCT04003142|144774324|SUPERIORITY||LSMean difference|-12.14|STANDARD_ERROR_OF_MEAN|4.07||0.003||95.0|-20.14|-4.14||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 9||-4.14|-20.14|0.003
72622111|NCT04003142|144774324|SUPERIORITY||LSMean difference|-19.73|STANDARD_ERROR_OF_MEAN|4.06|<|0.001|TWO_SIDED|95.0|-27.71|-11.755||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 9||-11.755|-27.71|<0.001
72469040|NCT02353871|144461662|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Statistical tests were two-sided with a type I error rate at 5%.|Regression, Logistic|Multivariate model, controlling for centre and stratification factors (i.e. gender and baseline ILA (maximum frown)) as fixed effects.||Comparison of ILA - BTX-A-HAC NG solution (50 U) versus Placebo at Day 15||||<0.0001
72469041|NCT02353871|144461662|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Statistical tests were two-sided with a type I error rate at 5%.|Regression, Logistic|Multivariate model, controlling for centre and stratification factors (i.e. gender and baseline ILA (maximum frown)) as fixed effects.||Comparison of ILA - BTX-A-HAC NG solution (50 U) versus Placebo at Day 29||||<0.0001
72469042|NCT02353871|144461662|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Statistical tests were two-sided with a type I error rate at 5%.|Regression, Logistic|Multivariate model, controlling for centre and stratification factors (i.e. gender and baseline ILA (maximum frown)) as fixed effects.||Comparison of ILA - BTX-A-HAC NG solution (50 U) versus Placebo at Day 57||||<0.0001
72469043|NCT02353871|144461662|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0008||||||Statistical tests were two-sided with a type I error rate at 5%.|Regression, Logistic|Multivariate model, controlling for centre and stratification factors (i.e. gender and baseline ILA (maximum frown)) as fixed effects.||Comparison of ILA - BTX-A-HAC NG solution (50 U) versus Placebo at Day 85||||0.0008
72469044|NCT02353871|144461662|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0065||||||Statistical tests were two-sided with a type I error rate at 5%.|Regression, Logistic|Multivariate model, controlling for centre and stratification factors (i.e. gender and baseline ILA (maximum frown)) as fixed effects.||Comparison of ILA - BTX-A-HAC NG solution (50 U) versus Placebo at Day 113||||0.0065
72469045|NCT02353871|144461662|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0643||||||Statistical tests were two-sided with a type I error rate at 5%.|Regression, Logistic|Multivariate model, controlling for centre and stratification factors (i.e. gender and baseline ILA (maximum frown)) as fixed effects.||Comparison of ILA - BTX-A-HAC NG solution (50 U) versus Placebo at Day 148||||0.0643
72469046|NCT02353871|144461662|SUPERIORITY_OR_OTHER_LEGACY|||||||0.367||||||Statistical tests were two-sided with a type I error rate at 5%.|Regression, Logistic|Multivariate model, controlling for centre and stratification factors (i.e. gender and baseline ILA (maximum frown)) as fixed effects.||Comparison of ILA - BTX-A-HAC NG solution (50 U) versus Placebo at Day 183||||0.3670
72469047|NCT02353871|144461663|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Statistical tests were two-sided with a type I error rate at 5%.|Regression, Logistic|Multivariate model, controlling for centre and stratification factors (i.e. gender and baseline ILA (maximum frown)) as fixed effects.||Comparison of SSA - BTX-A-HAC NG solution (50 U) versus Placebo at Day 8||||<0.0001
72469048|NCT02353871|144461663|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Statistical tests were two-sided with a type I error rate at 5%.|Regression, Logistic|Multivariate model, controlling for centre and stratification factors (i.e. gender and baseline ILA (maximum frown)) as fixed effects.||Comparison of SSA - BTX-A-HAC NG solution (50 U) versus Placebo at Day 15||||<0.0001
72469049|NCT02353871|144461663|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Statistical tests were two-sided with a type I error rate at 5%.|Regression, Logistic|Multivariate model, controlling for centre and stratification factors (i.e. gender and baseline ILA (maximum frown)) as fixed effects.||Comparison of SSA - BTX-A-HAC NG solution (50 U) versus Placebo at Day 29||||<0.0001
72469050|NCT02353871|144461663|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Statistical tests were two-sided with a type I error rate at 5%.|Regression, Logistic|Multivariate model, controlling for centre and stratification factors (i.e. gender and baseline ILA (maximum frown)) as fixed effects.||Comparison of SSA - BTX-A-HAC NG solution (50 U) versus Placebo at Day 57||||<0.0001
72469051|NCT02353871|144461663|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Statistical tests were two-sided with a type I error rate at 5%.|Regression, Logistic|Multivariate model, controlling for centre and stratification factors (i.e. gender and baseline ILA (maximum frown)) as fixed effects.||Comparison of SSA - Dysport 50 U versus Placebo at Day 85||||<0.0001
72565235|NCT03440424|144662009|OTHER||Percent ratio of geometric mean|84.36|||||TWO_SIDED|90.0|60.21|118.19|||||Percent ratio of geometric mean was calculated by dividing the geometric mean of test by geometric mean of reference, then multiplying the value by 100.|M9 metabolite||118.19|60.21|
72565236|NCT03440424|144662009|OTHER||Percent ratio of geometric mean|65.7|||||TWO_SIDED|90.0|46.89|92.05|||||Percent ratio of geometric mean was calculated by dividing the geometric mean of test by geometric mean of reference, then multiplying the value by 100.|M9 metabolite||92.05|46.89|
72565237|NCT03440424|144662009|OTHER||Percent ratio of geometric mean|94.74|||||TWO_SIDED|90.0|68.37|131.3|||||Percent ratio of geometric mean was calculated by dividing the geometric mean of test by geometric mean of reference, then multiplying the value by 100.|M10 metabolite||131.30|68.37|
72469052|NCT02353871|144461663|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Statistical tests were two-sided with a type I error rate at 5%.|Regression, Logistic|Multivariate model, controlling for centre and stratification factors (i.e. gender and baseline ILA (maximum frown)) as fixed effects.||Comparison of SSA - BTX-A-HAC NG solution (50 U) versus Placebo at Day 113||||<0.0001
72565238|NCT03440424|144662009|OTHER||Percent ratio of geometric mean|76.56|||||TWO_SIDED|90.0|55.24|106.09|||||Percent ratio of geometric mean was calculated by dividing the geometric mean of test by geometric mean of reference, then multiplying the value by 100.|M10 metabolite||106.09|55.24|
72394987|NCT00923247|144296440|SUPERIORITY_OR_OTHER|||||||0.016|||||||Mann-Whitney|(nonparametric unpaired t-test; assumed homoscedasticity)||Patients given bortezomib on cycle 1 day 1 vs. cycle 3 day 1. A paired analysis among same 14 patients on Phase 1 portion. To assess whether presence of vandetanib significantly altered bortezomib clearance.||||0.016
72394988|NCT00923247|144296441|SUPERIORITY_OR_OTHER|||||||0.01|||||||Mann-Whitney|(nonparametric unpaired t-test; assumed homoscedasticity)||Patients given bortezomib on cycle 1 day 1 vs. cycle 3 day 1. A paired analysis among same 14 patients on Phase I portion. To assess whether presence of vandetanib significantly altered bortezomib volume of distribution.||||0.010
72394989|NCT03791489|144296445|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
72394990|NCT03791489|144296446|SUPERIORITY||||||<|0.03||||||Threshold for statistical significance = p\<0.05.|t-test, 2 sided|||||||<0.03
72394991|NCT01691781|144296456|SUPERIORITY|||||||0.049||||||This p-value reflects the difference in PTH means among participants with primary hyperparathyroidism|t-test, 2 sided|||The statistical analysis compared the change in PTH, before and after ACE inhibitor therapy, among participants with primary hyperparathyroidism.||||0.049
72394992|NCT01691781|144296456|SUPERIORITY|||||||0.8||||||This p-value reflects the difference in PTH means among normal control participants without primary hyperparathyroidism|t-test, 2 sided|||The statistical analysis compared the change in PTH, before and after ACE inhibitor therapy, among normal control participants (without primary hyperparathyroidism).||||0.80
72469053|NCT02353871|144461663|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0011||||||Statistical tests were two-sided with a type I error rate at 5%.|Regression, Logistic|Multivariate model, controlling for centre and stratification factors (i.e. gender and baseline ILA (maximum frown)) as fixed effects.||Comparison of SSA - BTX-A-HAC NG solution (50 U) versus Placebo at Day 148||||0.0011
72469054|NCT02353871|144461663|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0036||||||Statistical tests were two-sided with a type I error rate at 5%.|Regression, Logistic|Multivariate model, controlling for centre and stratification factors (i.e. gender and baseline ILA (maximum frown)) as fixed effects.||Comparison of SSA - BTX-A-HAC NG solution (50 U) versus Placebo at Day 183||||0.0036
72469055|NCT02353871|144461664|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Statistical tests were two-sided with a type I error rate at 5%.|Regression, Logistic|Multivariate model, controlling for centre and stratification factors (i.e. gender and baseline ILA (maximum frown)) as fixed effects.||Comparison of subject's level of satisfaction - BTX-A-HAC NG solution (50 U) versus Placebo at Day 8||||<0.0001
72469056|NCT02353871|144461664|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Statistical tests were two-sided with a type I error rate at 5%.|Regression, Logistic|Multivariate model, controlling for centre and stratification factors (i.e. gender and baseline ILA (maximum frown)) as fixed effects.||Comparison of subject's level of satisfaction - BTX-A-HAC NG solution (50 U) versus Placebo at Day 15||||<0.0001
72469057|NCT02353871|144461664|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Statistical tests were two-sided with a type I error rate at 5%.|Regression, Logistic|Multivariate model, controlling for centre and stratification factors (i.e. gender and baseline ILA (maximum frown)) as fixed effects.||Comparison of subject's level of satisfaction - BTX-A-HAC NG solution (50 U) versus Placebo at Day 29||||<0.0001
72469058|NCT02353871|144461664|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Statistical tests were two-sided with a type I error rate at 5%.|Regression, Logistic|Multivariate model, controlling for centre and stratification factors (i.e. gender and baseline ILA (maximum frown)) as fixed effects.||Comparison of subject's level of satisfaction - BTX-A-HAC NG solution (50 U) versus Placebo at Day 57||||<0.0001
72622112|NCT04003142|144774324|SUPERIORITY||LSMean difference|-14.4|STANDARD_ERROR_OF_MEAN|4.0|<|0.001|TWO_SIDED|95.0|-22.25|-6.54||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 10||-6.54|-22.25|<0.001
72394993|NCT01691781|144296457|SUPERIORITY|||||||0.22||||||This p-value reflects the comparison of means among the primary hyperparathyroidism group only.|t-test, 2 sided|||The statistical analysis compared the change in urinary aldosterone excretion rate, before and after ACE inhibitor therapy, among participants with primary hyperparathyroidism.||||0.22
72394994|NCT01691781|144296457|SUPERIORITY|||||||0.86||||||This p-value reflects the mean difference in 24h aldosterone excretion rate among normal control participants without primary hyperparathyroidism|t-test, 2 sided|||The statistical analysis compared the change in urinary aldosterone excretion rate, before and after ACE inhibitor therapy, among normal control participants without primary hyperparathyroidism.||||0.86
72394995|NCT01691781|144296458|SUPERIORITY|||||||0.48||||||This p-value reflects the statistic for the comparison of mean calcium levels for the primary hyperparathyroidism group.|t-test, 2 sided|||The statistical analysis compared the change in serum calcium, before and after ACE inhibitor therapy, among participants with primary hyperparathyroidism.||||0.48
72394996|NCT01691781|144296458|SUPERIORITY|||||||0.8||||||This p-value reflects the statistic for the comparison of mean calcium levels for the normal control participants without primary hyperparathyroidism.|t-test, 2 sided|||The statistical analysis compared the change in serum calcium, before and after ACE inhibitor therapy, among normal control participants without primary hyperparathyroidism.||||0.80
72469059|NCT02353871|144461664|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Statistical tests were two-sided with a type I error rate at 5%.|Regression, Logistic|Multivariate model, controlling for centre and stratification factors (i.e. gender and baseline ILA (maximum frown)) as fixed effects.||Comparison of subject's level of satisfaction - BTX-A-HAC NG solution (50 U) versus Placebo at Day 85||||<0.0001
72469060|NCT02353871|144461664|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Statistical tests were two-sided with a type I error rate at 5%.|Regression, Logistic|Multivariate model, controlling for centre and stratification factors (i.e. gender and baseline ILA (maximum frown)) as fixed effects.||Comparison of subject's level of satisfaction - BTX-A-HAC NG solution (50 U) versus Placebo at Day 113||||<0.0001
72469061|NCT02353871|144461664|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Statistical tests were two-sided with a type I error rate at 5%.|Regression, Logistic|Multivariate model, controlling for centre and stratification factors (i.e. gender and baseline ILA (maximum frown)) as fixed effects.||Comparison of subject's level of satisfaction - BTX-A-HAC NG solution (50 U) versus Placebo at Day 148||||<0.0001
72622113|NCT04003142|144774324|SUPERIORITY||LSMean difference|-20.1|STANDARD_ERROR_OF_MEAN|3.98|<|0.001||95.0|-27.93|-12.27||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 10||-12.27|-27.93|<0.001
72622114|NCT04003142|144774324|SUPERIORITY||LSMean difference|-14.96|STANDARD_ERROR_OF_MEAN|4.07|<|0.001||95.0|-22.96|-6.96||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 11||-6.96|-22.96|<0.001
72622115|NCT04003142|144774324|SUPERIORITY||LSMean difference|-20.15|STANDARD_ERROR_OF_MEAN|4.06|<|0.001|TWO_SIDED|95.0|-28.13|-12.18||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 11||-12.18|-28.13|<0.001
72469062|NCT02353871|144461664|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Statistical tests were two-sided with a type I error rate at 5%.|Regression, Logistic|Multivariate model, controlling for centre and stratification factors (i.e. gender and baseline ILA (maximum frown)) as fixed effects.||Comparison of subject's level of satisfaction - BTX-A-HAC NG solution (50 U) versus Placebo at Day 183||||<0.0001
72469063|NCT02353871|144461665|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||Log Rank|||Comparison of time to onset of treatment response - BTX-A-HAC NG solution (50 U) versus Placebo||||<0.0001
72469064|NCT02353871|144461665|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|6.561|||<|0.0001|TWO_SIDED||||||Cox proportional hazard model|Centre, gender and ILA baseline severity score used as covariates.||Comparison of time to onset of treatment response - BTX-A-HAC NG solution (50 U) versus placebo||||<0.0001
72469065|NCT03434028|144461673|SUPERIORITY||difference in mortality rate|-0.9||||0.61|TWO_SIDED|95.0|-4.4|2.6|||Z-test|||||2.6|-4.4|0.61
72469066|NCT03434028|144461674|SUPERIORITY||Mean Difference (Final Values)|0.3|||||TWO_SIDED|95.0|-0.5|1.2|||||The mean values is an estimate from the Kaplan-Meier curve, thus it is correct as reported.|||1.2|-0.5|
72469067|NCT03434028|144461675|SUPERIORITY||Mean Difference (Final Values)|0.6|||||TWO_SIDED|95.0|-0.4|1.6||||||||1.6|-0.4|
72469068|NCT03434028|144461676|SUPERIORITY||Mean Difference (Final Values)|0.2|||||TWO_SIDED|95.0|-0.8|1.2||||||||1.2|-0.8|
72469069|NCT03434028|144461677|SUPERIORITY||Mean Difference (Final Values)|0.4|||||TWO_SIDED|95.0|-0.5|1.3||||||||1.3|-0.5|
72469070|NCT03434028|144461678|SUPERIORITY||Mean Difference (Final Values)|0.1|||||TWO_SIDED|95.0|-0.8|1.0||||||||1.0|-0.8|
72469071|NCT03434028|144461679|SUPERIORITY||Mean Difference (Final Values)|0.8|||||TWO_SIDED|95.0|-0.3|1.9||||||||1.9|-0.3|
72469072|NCT03434028|144461680|SUPERIORITY||Risk Difference (RD)|-1.7|||||TWO_SIDED|95.0|-5.1|1.7||||||||1.7|-5.1|
72469073|NCT03434028|144461681|SUPERIORITY||Risk Difference (RD)|0.0|||||TWO_SIDED|95.0|-1.8|1.8||||||||1.8|-1.8|
72469074|NCT03434028|144461682|SUPERIORITY||Mean Difference (Final Values)|0.0|||||TWO_SIDED|95.0|-0.1|0.1||||||||0.1|-0.1|
72469075|NCT03434028|144461683|SUPERIORITY||Mean Difference (Final Values)|0.1|||||TWO_SIDED|95.0|-0.3|0.4||||||||0.4|-0.3|
72469076|NCT03434028|144461684|SUPERIORITY||Risk Difference (RD)|-0.1|||||TWO_SIDED|95.0|-1.7|1.5||||||||1.5|-1.7|
72469077|NCT03434028|144461685|SUPERIORITY||Risk Difference (RD)|-1.0|||||TWO_SIDED|95.0|-3.7|1.7||||||||1.7|-3.7|
72469078|NCT03434028|144461686|SUPERIORITY||Risk Difference (RD)|0.5|||||TWO_SIDED|95.0|-3.6|4.7||||||||4.7|-3.6|
72469079|NCT02037776|144461687|SUPERIORITY|||||||0.038|||||||Wilcoxon (Mann-Whitney)|||Comparison between groups in Rikkunshito Placebo and Rikkunshito, based on the count of participants categorized in 1 (Significantly improved) through 7 (Much worse), using the Wilcoxon (Mann-Whitney).||||0.038
72469080|NCT02037776|144461688|SUPERIORITY|||||||0.027|||||||Wilcoxon (Mann-Whitney)|||Change from baseline in all symptoms of modified FSSG||||0.027
72469081|NCT02037776|144461688|SUPERIORITY|||||||0.089|||||||Wilcoxon (Mann-Whitney)|||Change from baseline in GERD symptoms of modified FSSG||||0.089
72469082|NCT02037776|144461688|SUPERIORITY|||||||0.148|||||||Wilcoxon (Mann-Whitney)|||Change from baseline in dyspeptic symptoms of modified FSSG||||0.148
72469083|NCT02037776|144461689|SUPERIORITY|||||||0.051|||||||Wilcoxon (Mann-Whitney)|||Change from baseline in total score of PAGI-SYM||||0.051
72469084|NCT02037776|144461689|SUPERIORITY|||||||0.947|||||||Wilcoxon (Mann-Whitney)|||Change from baseline in Heartburn/Regurgitation of PAGI-SYM||||0.947
72469085|NCT02037776|144461689|SUPERIORITY|||||||0.157|||||||Wilcoxon (Mann-Whitney)|||Change from baseline in Nausea/Vomiting of PAGI-SYM||||0.157
72469086|NCT02037776|144461689|SUPERIORITY|||||||0.004|||||||Wilcoxon (Mann-Whitney)|||Change from baseline in Postprandial Fullness/Early satiety of PAGI-SYM||||0.004
72469087|NCT02037776|144461689|SUPERIORITY|||||||0.011|||||||Wilcoxon (Mann-Whitney)|||Change from baseline in Bloating of PAGI-SYM||||0.011
72469088|NCT02037776|144461689|SUPERIORITY|||||||0.245|||||||Wilcoxon (Mann-Whitney)|||Change from baseline in Upper Abdominal Pain of PAGI-SYM||||0.245
72469089|NCT02037776|144461689|SUPERIORITY|||||||0.387|||||||Wilcoxon (Mann-Whitney)|||Change from baseline in Lower Abdominal Pain of PAGI-SYM||||0.387
72469090|NCT02037776|144461690|SUPERIORITY|||||||0.034|||||||Wilcoxon (Mann-Whitney)|||||||0.034
72469091|NCT02037776|144461691|SUPERIORITY|||||||0.27|||||||Wilcoxon (Mann-Whitney)|||Change from baseline in PCS of SF-8||||0.270
72469092|NCT02037776|144461691|SUPERIORITY|||||||0.342|||||||Wilcoxon (Mann-Whitney)|||Change from baseline in MCS of SF-8||||0.342
72469093|NCT02037776|144461692|SUPERIORITY|||||||0.036|||||||Wilcoxon (Mann-Whitney)|||Change from baseline in overall point score of HAD||||0.036
72469094|NCT02037776|144461692|SUPERIORITY|||||||0.084|||||||Wilcoxon (Mann-Whitney)|||Change from baseline in depression point score of HAD||||0.084
72469095|NCT02037776|144461692|SUPERIORITY|||||||0.022|||||||Wilcoxon (Mann-Whitney)|||Change from baseline in anxiety point score of HAD||||0.022
72469096|NCT01963169|144461693|SUPERIORITY||Effect size|0.54|||<|0.001|TWO_SIDED|||||\<0.05 (Threshold)|Mixed Models Analysis||The above values are for Knowledge outcome using the revised Osteoporosis Knowledge Test.|At 8 week, both intervention groups received the same Bone Power Program intervention. Thus, the analysis for the 8-week outcomes was completed as a two-armed RCT.||||< 0.001
72504329|NCT02723630|144539231|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean Ratio|93.5||||0.0403|TWO_SIDED|90.0|88.63|98.64||P value for formulation|Mixed Models Analysis||Geometric LS Mean ratio was back-transformed least squares mean and treatment difference mean|The effect of crystalline polymorph forms in the drug product on the PK parameters of lenvatinib was estimated using a mixed linear model of logarithmically transformed values of the primary PK parameters with fixed effects for treatment, period, and sequence and a random effect for participant within sequence.||98.64|88.63|0.0403
72565239|NCT03440424|144662011|OTHER||Percent ratio of geometric mean|99.14|||||TWO_SIDED|90.0|76.91|127.81|||||Percent ratio of geometric mean was calculated by dividing the geometric mean of test by geometric mean of reference, then multiplying the value by 100.|M4 metabolite||127.81|76.91|
72469097|NCT01963169|144461693|SUPERIORITY||Effect size|0.33|||<|0.001|TWO_SIDED|||||\<0.05 (threshold)|Mixed Models Analysis||The above values are for the exercise behavior variable assessed by the 9-item Self-Efficacy for Exercise scale.|At 8 weeks both intervention groups received the same BonePower intervention. Thus the analysis of 8-week outcome was completed as 2-armed RCT.||||<0.001
72469098|NCT01963169|144461693|SUPERIORITY||Effect size|0.2||||0.009|TWO_SIDED|||||\<0.05 (Threshold)|Mixed Models Analysis||The above values are for calcium outcome expectation..|At 8 weeks both intervention groups received the same BonePower intervention. Thus the analysis of 8-week outcome was completed as 2-armed RCT.||||0.009
72469099|NCT01963169|144461693|SUPERIORITY||Effect Size|0.18||||0.002|TWO_SIDED|||||\<0.05 (Threshold)|Mixed Models Analysis||The above values are for exercise self-efficacy.|At 8 weeks both intervention groups received the same BonePower intervention. Thus the analysis of 8-week outcome was completed as 2-armed RCT.||||0.002
72469100|NCT01963169|144461693|SUPERIORITY||Effect size|0.14||||0.032|TWO_SIDED|||||\<0.05 (Threshold)|Mixed Models Analysis||The above values are for exercise outcome expectation.|At 8 weeks both intervention groups received the same BonePower intervention. Thus the analysis of 8-week outcome was completed as 2-armed RCT.||||0.032
72469101|NCT03786744|144461701|SUPERIORITY||Mean Difference (Net)|9.0||||0.049367|TWO_SIDED|||||Alternative hypothesis: can be changed of speech, language, communication skills for Cord Blood versus Placebo groups in 2-month Threshold \<0.05|Wilcoxon (Mann-Whitney)|||The study results were statistically processed using parametric and non-parametric methods using STATA version 9.0, Statistica for Windows version 6.0. Changes from the beginning of therapy and after 1, 2, 6, 12 months were compared using the Wilcoxon criterion, data between the main group and the control group were compared using non-parametric method, Mann-Whitney test was used (data are presented in Me - median format with an indication of 25% and 75% quartile||||0.049367
72469102|NCT03786744|144461701|SUPERIORITY||Median Difference (Net)|9.0||||0.004072|TWO_SIDED|||||"Alternative hypothesis: can be changed average of 2-month of Health/Physical Development/Behaviour for Cord Blood versus Control groups.~Threshold \<0.05"|Wilcoxon (Mann-Whitney)|||The study results were statistically processed using parametric and non-parametric methods using STATA version 9.0, Statistica for Windows version 6.0 and MS Office Excel 2007. Changes from the beginning of therapy and after 1, 2, 6, 12 months were compared using the Wilcoxon criterion, data between the main group and the control group were compared using non-parametric method, Mann-Whitney test was used (data are presented in Me - median format with an indication of 25% and 75% quartile.||||0.004072
72469103|NCT03786744|144461701|SUPERIORITY||Mean Difference (Net)|9.0||||0.017258|TWO_SIDED|||||"Alternative hypothesis: can be changed average of 12-month of Health/Physical Development/Behaviour for Cord Blood versus Placebo groups.~Threshold \<0.05"|Wilcoxon (Mann-Whitney)|||The study results were statistically processed using parametric and non-parametric methods using STATA version 9.0, Statistica for Windows version 6.0 and MS Office Excel 2007. Changes from the beginning of therapy and after 1, 2, 6, 12 months were compared using the Wilcoxon criterion, data between the main group and the control group were compared using non-parametric method, Mann-Whitney test was used (data are presented in Me - median format with an indication of 25% and 75% quartile.||||0.017258
72469104|NCT03786744|144461701|SUPERIORITY||Mean Difference (Net)|10.0||||0.03121|TWO_SIDED|||||"Alternative hypothesis: can be changed average of 1-month of total score for Cord Blood versus Placebo groups.~Threshold \<0.05"|Wilcoxon (Mann-Whitney)|||The study results were statistically processed using parametric and non-parametric methods using STATA version 9.0, Statistica for Windows version 6.0. Changes from the beginning of therapy and after 1, 2, 6, 12 months were compared using the Wilcoxon criterion, data between the main group and the control group were compared using non-parametric method, Mann-Whitney test was used (data are presented in Me - median format with an indication of 25% and 75% quartile||||0.031210
72469105|NCT03786744|144461701|SUPERIORITY||Mean Difference (Net)|24.0||||0.00194|TWO_SIDED|||||"Alternative hypothesis: can be changed average of 2-month of Total score for Cord Blood versus Placebo groups.~Threshold \<0.05"|Wilcoxon (Mann-Whitney)|||The study results were statistically processed using parametric and non-parametric methods using STATA version 9.0, Statistica for Windows version 6.0. Changes from the beginning of therapy and after 1, 2, 6, 12 months were compared using the Wilcoxon criterion, data between the main group and the control group were compared using non-parametric method, Mann-Whitney test was used (data are presented in Me - median format with an indication of 25% and 75% quartile||||0.001940
72469106|NCT03786744|144461701|SUPERIORITY||Mean Difference (Net)|15.0||||0.03121|TWO_SIDED|||||"Alternative hypothesis: can be changed average of 6-month of Total score for Cord Blood versus Placebo groups.~Threshold \<0.05"|Wilcoxon (Mann-Whitney)|||The study results were statistically processed using parametric and non-parametric methods using STATA version 9.0, Statistica for Windows version 6.0. Changes from the beginning of therapy and after 1, 2, 6, 12 months were compared using the Wilcoxon criterion, data between the main group and the control group were compared using non-parametric method, Mann-Whitney test was used (data are presented in Me - median format with an indication of 25% and 75% quartile||||0.031210
72504330|NCT02723630|144539232|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean Ratio|100.29||||0.9373|TWO_SIDED|90.0|94.37|106.58||P value for formulation|Mixed Models Analysis||Geometric LS Mean ratio was back-transformed least squares mean and treatment difference mean|The effect of crystalline polymorph forms in the drug product on the PK parameters of lenvatinib was estimated using a mixed linear model of logarithmically transformed values of the primary PK parameters with fixed effects for treatment, period, and sequence and a random effect for participant within sequence.||106.58|94.37|0.9373
72565240|NCT03440424|144662011|OTHER||Percent ratio of geometric mean|69.66|||||TWO_SIDED|90.0|54.03|89.79|||||Percent ratio of geometric mean was calculated by dividing the geometric mean of test by geometric mean of reference, then multiplying the value by 100.|M4 metabolite||89.79|54.03|
72622116|NCT04003142|144774324|SUPERIORITY||LSMean difference|-13.64|STANDARD_ERROR_OF_MEAN|4.07|<|0.001||95.0|-21.62|-5.65||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 12||-5.65|-21.62|<0.001
72469107|NCT03786744|144461701|SUPERIORITY||Mean Difference (Net)|16.0||||0.01133|TWO_SIDED|||||"Alternative hypothesis: can be changed average of 12-month of Total score for Cord Blood versus Placebo groups.~Threshold \<0.05"|Wilcoxon (Mann-Whitney)|||The study results were statistically processed using parametric and non-parametric methods using STATA version 9.0, Statistica for Windows version 6.0. Changes from the beginning of therapy and after 1, 2, 6, 12 months were compared using the Wilcoxon criterion, data between the main group and the control group were compared using non-parametric method, Mann-Whitney test was used (data are presented in Me - median format with an indication of 25% and 75% quartile||||0.011330
72622117|NCT04003142|144774324|SUPERIORITY||LSMean difference|-18.94|STANDARD_ERROR_OF_MEAN|4.05|<|0.001||95.0|-26.89|-10.98||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 12||-10.98|-26.89|<0.001
72622118|NCT04003142|144774325|SUPERIORITY||Odds Ratio (OR)|1.881||||0.02||95.0|1.11|3.233||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 1||3.233|1.110|0.020
72622119|NCT04003142|144774325|SUPERIORITY||Odds Ratio (OR)|2.645|||<|0.001|TWO_SIDED|95.0|1.585|4.498||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 1||4.498|1.585|<0.001
72469108|NCT04683510|144461714|SUPERIORITY||Odds Ratio (OR)|1.647||||0.2345|TWO_SIDED|95.0|0.724|3.746|||Regression, Logistic|||||3.746|0.724|0.2345
72469109|NCT04683510|144461714|SUPERIORITY||Odds Ratio (OR)|1.897||||0.124|TWO_SIDED|95.0|0.839|4.291|||Regression, Logistic|||||4.291|0.839|0.124
72469110|NCT04683510|144461715|SUPERIORITY||Odds Ratio (OR)|0.905||||0.2352|TWO_SIDED|95.0|0.768|1.067|||Regression, Logistic|||||1.067|0.768|0.2352
72469111|NCT04683510|144461715|SUPERIORITY||Odds Ratio (OR)|0.924||||0.3418|TWO_SIDED|95.0|0.785|1.088|||Regression, Logistic|||||1.088|0.785|0.3418
72469112|NCT04683510|144461716|SUPERIORITY||Odds Ratio (OR)|1.22||||0.1653|TWO_SIDED|95.0|0.921|1.615|||Regression, Logistic|||||1.615|0.921|0.1653
72469113|NCT04683510|144461716|SUPERIORITY||Odds Ratio (OR)|1.213||||0.181|TWO_SIDED|95.0|0.914|1.609|||Regression, Logistic|||||1.609|0.914|0.181
72469114|NCT02353312|144461728|EQUIVALENCE|Pairwise comparisons of VO2 max means with equal variances between participant on and off treatment.||||||0.823|||||||t-test, 2 sided|||||||0.823
72469115|NCT03522389|144461730|SUPERIORITY|||||||0.003|||||||ANOVA|||After 4 weeks of training - Baseline (T2-T1)||||0.003
72469116|NCT03522389|144461730|SUPERIORITY||||||<|0.001|||||||ANOVA|||1-month follow up - Baseline (T3-T1)||||<0.001
72469117|NCT03522389|144461730|SUPERIORITY||||||<|0.001|||||||ANOVA|||Within group comparison||||<0.001
72469118|NCT03522389|144461730|SUPERIORITY|||||||0.006|||||||ANOVA|||Within group comparison||||0.006
72469119|NCT03522389|144461730|SUPERIORITY|||||||0.793|||||||ANOVA|||Within group comparison||||0.793
72469120|NCT03522389|144461731|SUPERIORITY||||||<|0.001|||||||ANOVA|||After 4 weeks of training - Baseline (T2-T1)||||<0.001
72469121|NCT03522389|144461731|SUPERIORITY|||||||0.039|||||||ANOVA|||1-month follow-up - Baseline (T3-T1)||||0.039
72395006|NCT04853225|144296588|OTHER||Adjusted rate of change|-59.46|||||||||||||Pre-bronchodilator. Adjusted rate of change was analyzed using Random Coefficient Model. The model was fitted with an unstructured variance-covariance matrix.|||||
72395007|NCT04853225|144296588|OTHER||Adjusted rate of change|-62.73|||||||||||||Post-bronchodilator. Adjusted rate of change was analyzed using Random Coefficient Model. The model was fitted with an unstructured variance-covariance matrix.|||||
72469122|NCT03522389|144461731|SUPERIORITY||||||<|0.001|||||||ANOVA|||Within group comparison||||<0.001
72469123|NCT03522389|144461731|SUPERIORITY|||||||0.002|||||||ANOVA|||Within group comparison||||0.002
72469124|NCT03522389|144461731|SUPERIORITY|||||||0.117|||||||ANOVA|||Within group comparison||||0.117
72469125|NCT03522389|144461732|SUPERIORITY|||||||0.924|||||||ANOVA|||After 4 weeks of training - Baseline (T2-T1)||||0.924
72469126|NCT03522389|144461732|SUPERIORITY|||||||0.855|||||||ANOVA|||1-month follow-up - Baseline (T3-T1)||||0.855
72469127|NCT03522389|144461732|SUPERIORITY|||||||0.937|||||||ANOVA|||Within group comparison||||0.937
72469128|NCT03522389|144461732|SUPERIORITY|||||||0.97|||||||ANOVA|||Within group comparison||||0.970
72469129|NCT03522389|144461732|SUPERIORITY|||||||0.242|||||||ANOVA|||Within group comparison||||0.242
72469130|NCT03522389|144461733|SUPERIORITY|||||||0.161|||||||ANOVA|||After 4 weeks of training - Baseline (T2-T1)||||0.161
72469131|NCT03522389|144461733|SUPERIORITY|||||||0.161|||||||ANOVA|||1-month follow-up - Baseline (T3-T1)||||0.161
72469132|NCT03522389|144461733|SUPERIORITY|||||||0.076|||||||ANOVA|||Within group comparison||||0.076
72469133|NCT03522389|144461733|SUPERIORITY|||||||0.211|||||||ANOVA|||Within group comparison||||0.211
72469134|NCT03522389|144461733|SUPERIORITY|||||||0.573|||||||ANOVA|||Within group comparison||||0.573
72469135|NCT03522389|144461734|SUPERIORITY|||||||0.445|||||||ANOVA|||After 4 weeks of training - Baseline (T2-T1)||||0.445
72469136|NCT03522389|144461734|SUPERIORITY|||||||0.046|||||||ANOVA|||1-month follow-up - Baseline (T3-T1)||||0.046
72469137|NCT03522389|144461734|SUPERIORITY||||||<|0.001|||||||ANOVA|||Within group comparison||||<0.001
72469138|NCT03522389|144461734|SUPERIORITY|||||||0.028|||||||ANOVA|||Within group comparison||||0.028
72469139|NCT03522389|144461734|SUPERIORITY|||||||0.002|||||||ANOVA|||Within group comparison||||0.002
72469140|NCT02242643|144461797|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority criterion: The upper limit of the two-sided 95% CI for the difference in SCR (Fluzone® Quadrivalent Group minus FluLaval™ Quadrivalent Group) did not exceed 10% for each of the four strains.|Seroconversion rate (SCR) Difference (%)|-6.32|||||TWO_SIDED|95.0|-10.34|-2.27|||||For A/California/7/2009 (H1N1) vaccine strain.|||-2.27|-10.34|
72469141|NCT02242643|144461797|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority criterion: The upper limit of the two-sided 95% CI for the difference in SCR (Fluzone® Quadrivalent Group minus FluLaval™ Quadrivalent Group) did not exceed 10% for each of the four strains.|SCR Difference (%)|-6.74|||||TWO_SIDED|95.0|-10.68|-2.8|||||For A/Texas/50/2012 (H3N2) vaccine strain|||-2.80|-10.68|
72469142|NCT02242643|144461797|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority criterion: The upper limit of the two-sided 95% CI for the difference in SCR (Fluzone® Quadrivalent Group minus FluLaval™ Quadrivalent Group) did not exceed 10% for each of the four strains.|SCR Difference (%)|-16.38|||||TWO_SIDED|95.0|-20.68|-12.02|||||For B/Massachusetts/2/2012 (Yamagata) vaccine strain|||-12.02|-20.68|
72469143|NCT02242643|144461797|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority criterion: The upper limit of the two-sided 95% CI for the difference in SCR (Fluzone® Quadrivalent Group minus FluLaval™ Quadrivalent Group) did not exceed 10% for each of the four strains.|SCR Difference (%)|-11.75|||||TWO_SIDED|95.0|-15.28|-8.21|||||For B/Brisbane/60/2008 (Victoria) vaccine strain.|||-8.21|-15.28|
72469144|NCT02242643|144461798|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority criterion: The upper limit of the two-sided 95% confidence interval (CI) for the GMT ratio (Fluzone® Quadrivalent Group/FluLaval™ Quadrivalent Group) did not exceed 1.5 for each of the four strains.|Adjusted GMT ratio|0.85|||||TWO_SIDED|95.0|0.77|0.95|||||The GMTs were used to calculate the Adjusted GMTs, which in turn were used to calculate the Adjusted GMT ratio with 95% confidence interval (Ancova model: adjustment for baseline titer - pooled variance).|||0.95|0.77|
72469145|NCT02242643|144461798|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority criterion: The upper limit of the two-sided 95% confidence interval (CI) for the GMT ratio (Fluzone® Quadrivalent Group/FluLaval™ Quadrivalent Group) did not exceed 1.5 for each of the four strains.|Adjusted GMT Ratio|0.85|||||TWO_SIDED|95.0|0.77|0.94|||||The GMTs were used to calculate the Adjusted GMTs, which in turn were used to calculate the Adjusted GMT ratio with 95% confidence interval (Ancova model: adjustment for baseline titer - pooled variance).|||0.94|0.77|
72469146|NCT02242643|144461798|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority criterion: The upper limit of the two-sided 95% confidence interval (CI) for the GMT ratio (Fluzone® Quadrivalent Group/FluLaval™ Quadrivalent Group) did not exceed 1.5 for each of the four strains.|Adjusted GMT Ratio|0.65|||||TWO_SIDED|95.0|0.59|0.71|||||The GMTs were used to calculate the Adjusted GMTs, which in turn were used to calculate the Adjusted GMT ratio with 95% confidence interval (Ancova model: adjustment for baseline titer - pooled variance).|||0.71|0.59|
72469147|NCT02242643|144461798|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority criterion: The upper limit of the two-sided 95% confidence interval (CI) for the GMT ratio (Fluzone® Quadrivalent Group/FluLaval™ Quadrivalent Group) did not exceed 1.5 for each of the four strains.|Adjusted GMT Ratio|0.62|||||TWO_SIDED|95.0|0.56|0.69|||||The GMTs were used to calculate the Adjusted GMTs, which in turn were used to calculate the Adjusted GMT ratio with 95% confidence interval (Ancova model: adjustment for baseline titer - pooled variance).|||0.69|0.56|
72469148|NCT05093504|144461828|SUPERIORITY|||||||0.02|||||||Wilcoxon (Mann-Whitney)|||||||0.020
72469149|NCT02272244|144461837|SUPERIORITY||Odds Ratio (OR)|4.83|||<|0.001|TWO_SIDED|95.0|3.08|7.58|||Regression, Logistic|Model adjusted for age, sex, practice, baseline preferred test and baseline overall decision stage||||7.58|3.08|<0.001
72469150|NCT02272244|144461838|SUPERIORITY||Odds Ratio (OR)|4.91|||<|0.001|TWO_SIDED|95.0|2.55|9.47|||Regression, Logistic|Model compares Forward Change to No Change or Backwards Change and is adjusted for all baseline covariates.||||9.47|2.55|<0.001
72469151|NCT02272244|144461839|SUPERIORITY||||||<|0.001|||||||Regression, Multinomial|Model compared rates of SBT, CX and none; model is adjusted for age, sex, practice, baseline preferred test and baseline overall decision stage|||Reference for the outcome is No Screening; reference for the study group is the Standard Intervention group.|||<0.001
72469152|NCT02272244|144461839|SUPERIORITY||Odds Ratio (OR)|4.2||||0.001|TWO_SIDED|95.0|2.63|6.7|||Odds Ratio (OR)|Stool Blood Test vs None||||6.70|2.63|0.001
72469153|NCT02272244|144461839|SUPERIORITY|Colonscopy vs None|Odds Ratio (OR)|8.79||||0.001|TWO_SIDED|95.0|4.13|18.74|||Odds Ratio (OR)|||||18.74|4.13|0.001
72469154|NCT02272244|144461840|SUPERIORITY||Mean Difference (Final Values)|-0.01||||0.862|TWO_SIDED|95.0|-0.15|0.13|||Regression, Linear|Model of difference in Preventive Health Model (PHM) total score adjusts for all baseline covariates.|Model compares DSNI to SI.|||0.13|-0.15|0.862
72469155|NCT02272244|144461840|SUPERIORITY||Mean Difference (Final Values)|0.04||||0.88|TWO_SIDED|95.0|-0.47|0.55|||Regression, Linear|Model of knowledge test score adjusts for all baseline covariates|Model compares DSNI to SI.|||.55|-.47|0.880
72469156|NCT03733899|144461878|SUPERIORITY|Subjective comfort was analyzed using linear mixed model. Statistical inference was made based on the 95% confidence interval constructed for the least square mean difference.|Least-Square Mean Difference|2.6|STANDARD_ERROR_OF_MEAN|4.96|||TWO_SIDED|95.0|-7.3|12.4|||Linear Mixed Model||Difference was calculated as Test - Placebo|5-Mintues Post Treatment||12.4|-7.3|
72469157|NCT03733899|144461878|SUPERIORITY|Subjective comfort was analyzed using linear mixed model. Statistical inference was made based on the 95% confidence interval constructed for the least square mean difference.|Least-square Mean Difference|0.9|STANDARD_ERROR_OF_MEAN|5.3|||TWO_SIDED|95.0|-9.6|11.5|||Linear Mixed Model||Difference was calculated as Test - Placebo|10-Minutes Post Treatment||11.5|-9.6|
72504331|NCT02723630|144539232|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean Ratio|95.17||||0.0682|TWO_SIDED|90.0|91.03|99.5||P value for formulation|Mixed Models Analysis||Geometric LS Mean ratio was back-transformed least squares mean and treatment difference mean|The effect of crystalline polymorph forms in the drug product on the PK parameters of lenvatinib was estimated using a mixed linear model of logarithmically transformed values of the primary PK parameters with fixed effects for treatment, period, and sequence and a random effect for participant within sequence.||99.50|91.03|0.0682
72469158|NCT03733899|144461878|SUPERIORITY|Subjective comfort was analyzed using linear mixed model. Statistical inference was made based on the 95% confidence interval constructed for the least square mean difference.|Least-Square Mean Difference|0.8|STANDARD_ERROR_OF_MEAN|4.67|||TWO_SIDED|95.0|-8.2|9.8|||Linear Mixed Model||difference was calculated as Test - Placebo.|5-Minutes Post Treatment||9.8|-8.2|
72504867|NCT02988986|144540819|SUPERIORITY|Based on prior data for Ki67 changes in the tamoxifen arm alone, we will assume null hypothesis and alternative hypotheses of 60% and 80% reduction in Ki67, respectively. A sample of 25 patients will provide 86% power to detect the hypothesized reduction in Ki67 with 5% alpha based on a two-sided, one sample t-test of mean percent change in Ki67 level.|||||=|0.0023|||||||Wilcoxon (Mann-Whitney)|||The primary endpoint was the change in Ki67 after 6 weeks of treatment.||||=0.0023
72469159|NCT03733899|144461878|SUPERIORITY|Subjective comfort was analyzed using linear mixed model. Statistical inference was made based on the 95% confidence interval constructed for the least square mean difference.|Least-square Mean Difference|2.9|STANDARD_ERROR_OF_MEAN|4.67|||TWO_SIDED|95.0|-6.5|12.2|||Linear Mixed Model||Difference was calculated as Test - Placebo.|10-Mintues Post Treatment||12.2|-6.5|
72504332|NCT02723630|144539233|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean Ratio|98.73||||0.8448|TWO_SIDED|90.0|88.57|110.06||P value for formulation|Mixed Models Analysis||Geometric Least Squares Mean Ratio was back-transformed least squares mean and treatment difference mean|The effect of crystalline polymorph forms in the drug product on the PK parameters of lenvatinib was estimated using a mixed linear model of logarithmically transformed values of the primary PK parameters with fixed effects for treatment, period, and sequence and a random effect for participant within sequence.||110.06|88.57|0.8448
72504333|NCT02723630|144539233|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean Ratio|90.64||||0.0498|TWO_SIDED|90.0|83.51|98.38||P value for formulation|Mixed Models Analysis||Geometric LS Mean ratio was back-transformed least squares mean and treatment difference mean|The effect of crystalline polymorph forms in the drug product on the PK parameters of lenvatinib was estimated using a mixed linear model of logarithmically transformed values of the primary PK parameters with fixed effects for treatment, period, and sequence and a random effect for participant within sequence.||98.38|83.51|0.0498
72504334|NCT01184989|144539237|NON_INFERIORITY_OR_EQUIVALENCE|Bioavailability analysis|Ratio|102.16|STANDARD_DEVIATION|22.8||||90.0|97.64|106.893|||Geometric Mean||Dispersion value is actually the intraindividual gCV.|Estimated local measurements are compared to HPLC-MS/MS measurements. The comparison was done for the 136 quantifiable measurements.||106.893|97.640|
72504335|NCT01184989|144539238|NON_INFERIORITY_OR_EQUIVALENCE|Bioavailability analysis|Ratio|92.37|STANDARD_DEVIATION|23.5||||90.0|90.079|94.719|||Geometric Mean||The Dispersion Value is actually the intraindividual gCV.|Estimated central measurements are compared to HPLC-MS/MS measurements. The comparison was done for the 468 quantifiable measurements.||94.719|90.079|
72469160|NCT03733899|144461878|SUPERIORITY|Subjective comfort was analyzed using linear mixed model. Statistical inference was made based on the 95% confidence interval constructed for the least square mean difference.|Least-square Mean Difference|3.0|STANDARD_ERROR_OF_MEAN|4.37|||TWO_SIDED|95.0|-5.7|11.7|||Linear Mixed Model||Difference was calculated as Test - Placebo.|5-Mintues Post Treatment||11.7|-5.7|
72504336|NCT01570491|144539240|SUPERIORITY_OR_OTHER|||||||0.83|||||||Kruskal-Wallis|||"We hypothesized that real-time US guidance would result in a 20% lower number of attempts compared to the control group.~At the 0.05 level of significance with a power of 0.8, we will require a minimum of 20 patients per group, therefore we planned to recruit 40 patients in total."||||0.83
72504337|NCT01570491|144539241|SUPERIORITY|||||||0.001|||||||Kruskal-Wallis|||||||0.001
72504338|NCT01570491|144539242|SUPERIORITY|||||||0.09|||||||Kruskal-Wallis|||||||0.09
72504339|NCT01570491|144539243|SUPERIORITY|||||||0.06|||||||Kruskal-Wallis|||||||0.06
72504340|NCT01015443|144539252|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.032||||0.921|TWO_SIDED|95.0|0.552|1.931|||Adjusted log rank|||||1.931|0.552|0.921
72504341|NCT03443024|144539293|SUPERIORITY|||||||0.0165|||||||ANCOVA|||||||0.0165
72504342|NCT03443024|144539293|SUPERIORITY|||||||0.0022|TWO_SIDED|95.0|||||ANCOVA|||||||0.0022
72504343|NCT03443024|144539293|SUPERIORITY|||||||0.0005|TWO_SIDED|95.0|||||ANCOVA|||||||0.0005
72504344|NCT03443024|144539294|SUPERIORITY|||||||0.061|||||||Cochran-Mantel-Haenszel|||||||0.0610
72504345|NCT03443024|144539294|SUPERIORITY|||||||0.0021|||||||Cochran-Mantel-Haenszel|||||||0.0021
72504346|NCT03443024|144539294|SUPERIORITY|||||||0.0005|||||||Cochran-Mantel-Haenszel|||||||0.0005
72504347|NCT03443024|144539295|SUPERIORITY|||||||0.1917|||||||Cochran-Mantel-Haenszel|||||||0.1917
72504348|NCT03443024|144539295|SUPERIORITY|||||||0.0392|||||||Cochran-Mantel-Haenszel|||||||0.0392
72504349|NCT03443024|144539295|SUPERIORITY|||||||0.0023|||||||Cochran-Mantel-Haenszel|||||||0.0023
72504350|NCT03443024|144539296|SUPERIORITY|||||||0.2043|||||||Cochran-Mantel-Haenszel|||||||0.2043
72504351|NCT03443024|144539296|SUPERIORITY|||||||0.0021|||||||Cochran-Mantel-Haenszel|||||||0.0021
72504352|NCT03443024|144539296|SUPERIORITY|||||||0.0018|||||||Cochran-Mantel-Haenszel|||||||0.0018
72504353|NCT03443024|144539297|SUPERIORITY|||||||0.0554|||||||Cochran-Mantel-Haenszel|||||||0.0554
72504354|NCT03443024|144539297|SUPERIORITY|||||||0.0037|||||||Cochran-Mantel-Haenszel|||||||0.0037
72395008|NCT04853225|144296588|OTHER||Adjusted rate of change|-48.54|||||||||||||Pre-bronchodilator. Adjusted rate of change was analyzed using Random Coefficient Model. The model was fitted with an unstructured variance-covariance matrix.|||||
72504355|NCT03443024|144539297|SUPERIORITY|||||||0.0008|||||||Cochran-Mantel-Haenszel|||||||0.0008
72504356|NCT03443024|144539298|SUPERIORITY|||||||0.08|||||||Cochran-Mantel-Haenszel|||||||0.0800
72504357|NCT03443024|144539298|SUPERIORITY|||||||0.0062|||||||Cochran-Mantel-Haenszel|||||||0.0062
72504358|NCT03443024|144539298|SUPERIORITY|||||||0.0006|||||||Cochran-Mantel-Haenszel|||||||0.0006
72504359|NCT03443024|144539299|SUPERIORITY|||||||0.0773|||||||ANCOVA|||||||0.0773
72504360|NCT03443024|144539299|SUPERIORITY|||||||0.0459|||||||ANCOVA|||||||0.0459
72504361|NCT03443024|144539299|SUPERIORITY|||||||0.0062|TWO_SIDED|95.0|||||ANCOVA|||||||0.0062
72504362|NCT03443024|144539300|SUPERIORITY|||||||0.0047|||||||ANCOVA|||||||0.0047
72504363|NCT03443024|144539300|SUPERIORITY|||||||0.0002|TWO_SIDED|95.0|||||ANCOVA|||||||0.0002
72504364|NCT03443024|144539300|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
72504365|NCT03443024|144539301|SUPERIORITY|||||||0.6674|||||||Cochran-Mantel-Haenszel|||||||0.6674
72504366|NCT03443024|144539301|SUPERIORITY|||||||0.1166|||||||Cochran-Mantel-Haenszel|||||||0.1166
72504367|NCT03443024|144539301|SUPERIORITY|||||||0.0119|||||||Cochran-Mantel-Haenszel|||||||0.0119
72504368|NCT03443024|144539302|SUPERIORITY|||||||0.2371|||||||Cochran-Mantel-Haenszel|||||||0.2371
72504369|NCT03443024|144539302|SUPERIORITY|||||||0.1067|||||||Cochran-Mantel-Haenszel|||||||0.1067
72504370|NCT03443024|144539302|SUPERIORITY|||||||0.0008|||||||Cochran-Mantel-Haenszel|||||||0.0008
72504371|NCT03443024|144539303|SUPERIORITY|||||||0.4631|||||||ANCOVA|||||||0.4631
72504372|NCT03443024|144539303|SUPERIORITY|||||||0.0368|||||||ANCOVA|||||||0.0368
72504373|NCT03443024|144539303|SUPERIORITY|||||||0.0232|||||||ANCOVA|||||||0.0232
72504374|NCT03443024|144539304|SUPERIORITY|||||||0.4729|||||||ANCOVA|||||||0.4729
72504375|NCT03443024|144539304|SUPERIORITY|||||||0.0282|||||||ANCOVA|||||||0.0282
72504376|NCT03443024|144539304|SUPERIORITY|||||||0.0506|||||||ANCOVA|||||||0.0506
72469161|NCT03733899|144461878|SUPERIORITY|Subjective comfort was analyzed using linear mixed model. Statistical inference was made based on the 95% confidence interval constructed for the least square mean difference.|Least-sqaure Mean Difference|7.7|STANDARD_ERROR_OF_MEAN|4.54|||TWO_SIDED|95.0|-1.4|16.8|||Linear Mixed Model||difference was calculated as Test - Placebo.|10-Mintues Post Treatment||16.8|-1.4|
72622120|NCT04003142|144774325|SUPERIORITY||Odds Ratio (OR)|2.464|||<|0.001||95.0|1.535|4.001||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 2||4.001|1.535|<0.001
72622121|NCT04003142|144774325|SUPERIORITY||Odds Ratio (OR)|2.464|||<|0.001|TWO_SIDED|95.0|1.534|4.004||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 2||4.004|1.534|<0.001
72469162|NCT03733899|144461879|SUPERIORITY|Subjective comfort was analyzed using linear mixed model. Statistical inference was made based on the 95% confidence interval constructed for the least square mean difference.|Least-Square Mean Difference|2.1|STANDARD_ERROR_OF_MEAN|6.22|||TWO_SIDED|95.0|-10.3|14.4|||Linear Mixed Model||Difference was calculated as Test - Placebo|5-Mintues Post Treatment||14.4|-10.3|
72469163|NCT03733899|144461879|SUPERIORITY|Subjective comfort was analyzed using linear mixed model. Statistical inference was made based on the 95% confidence interval constructed for the least square mean difference.|Least-square Mean Difference|0.4|STANDARD_ERROR_OF_MEAN|6.3|||TWO_SIDED|95.0|-12.1|12.9|||Linear Mixed Model||Difference was calculated as Test - Placebo|10-Minutes Post Treatment||12.9|-12.1|
72469164|NCT03733899|144461879|SUPERIORITY|Subjective comfort was analyzed using linear mixed model. Statistical inference was made based on the 95% confidence interval constructed for the least square mean difference.|Least-Square Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|5.92|||TWO_SIDED|95.0|-11.4|12.1|||Linear Mixed Model||difference was calculated as Test - Placebo.|5-Minutes Post Treatment||12.1|-11.4|
72469165|NCT03733899|144461879|SUPERIORITY|Subjective comfort was analyzed using linear mixed model. Statistical inference was made based on the 95% confidence interval constructed for the least square mean difference.|Least-square Mean Difference|2.4|STANDARD_ERROR_OF_MEAN|5.83|||TWO_SIDED|95.0|-9.2|14.0|||Linear Mixed Model||Difference was calculated as Test - Placebo.|10-Mintues Post Treatment||14.0|-9.2|
72469166|NCT03733899|144461879|SUPERIORITY|Subjective comfort was analyzed using linear mixed model. Statistical inference was made based on the 95% confidence interval constructed for the least square mean difference.|Least-square Mean Difference|2.9|STANDARD_ERROR_OF_MEAN|5.76|||TWO_SIDED|95.0|-8.5|14.3|||Linear Mixed Model||Difference was calculated as Test - Placebo.|5-Mintues Post Treatment||14.3|-8.5|
72469167|NCT03733899|144461879|SUPERIORITY|Subjective comfort was analyzed using linear mixed model. Statistical inference was made based on the 95% confidence interval constructed for the least square mean difference.|Least-sqaure Mean Difference|7.6|STANDARD_ERROR_OF_MEAN|5.67|||TWO_SIDED|95.0|-3.7|18.8|||Linear Mixed Model||difference was calculated as Test - Placebo.|10-Mintues Post Treatment||18.8|-3.7|
72469168|NCT03733899|144461880|SUPERIORITY|Superiority was concluded if the lower limit of 95% confidence interval was greater than 0 for at least one of the three ocular regions (upper lid margin, lower lid margin, or cornea).|Mean Difference (Final Values)|-4.0|STANDARD_ERROR_OF_MEAN|4.61|||TWO_SIDED|95.0|-13.2|5.1|||Mixed Models Analysis|||5-Minutes Post Treatment|Mean difference was calculated as (5-min Post-Treatment MINUS Immediate Post-insertion).|5.1|-13.2|
72469169|NCT03733899|144461880|SUPERIORITY|Superiority was concluded if the lower limit of 95% confidence interval was greater than 0 for at least one of the three ocular regions (upper lid margin, lower lid margin, or cornea).|Mean Difference (Final Values)|-4.3|STANDARD_ERROR_OF_MEAN|4.85|||TWO_SIDED|95.0|-13.9|5.3|||Mixed Models Analysis|||10-Minutes Post Treatment|Mean difference was calculated as (10-min Post-Treatment MINUS Immediate Post-insertion).|5.3|-13.9|
72469170|NCT03733899|144461880|SUPERIORITY|Superiority was concluded if the lower limit of 95% confidence interval was greater than 0 for at least one of the three ocular regions (upper lid margin, lower lid margin, or cornea).|Mean Difference (Final Values)|-16.4|STANDARD_ERROR_OF_MEAN|4.04|||TWO_SIDED|95.0|-24.4|-8.3|||Mixed Models Analysis|||5-Minutes Post Treatment|Mean difference was calculated as (5-min Post-Treatment MINUS Immediate Post-insertion).|-8.3|-24.4|
72469171|NCT03733899|144461880|SUPERIORITY|Superiority was concluded if the lower limit of 95% confidence interval was greater than 0 for at least one of the three ocular regions (upper lid margin, lower lid margin, or cornea).|Mean Difference (Final Values)|-9.6|STANDARD_ERROR_OF_MEAN|4.14|||TWO_SIDED|95.0|-17.8|-1.4|||Mixed Models Analysis|||10-Minutes Post Treatment|Mean difference was calculated as (10-min Post-Treatment MINUS Immediate Post-insertion).|-1.4|-17.8|
72469172|NCT03733899|144461880|SUPERIORITY|Superiority was concluded if the lower limit of 95% confidence interval was greater than 0 for at least one of the three ocular regions (upper lid margin, lower lid margin, or cornea).|Mean Difference (Final Values)|-12.3|STANDARD_ERROR_OF_MEAN|4.15|||TWO_SIDED|95.0|-20.6|-4.1|||Mixed Models Analysis|||5-Minutes Post Treatment|Mean difference was calculated as (5-min Post-Treatment MINUS Immediate Post-insertion).|-4.1|-20.6|
72469173|NCT03733899|144461880|SUPERIORITY|Superiority was concluded if the lower limit of 95% confidence interval was greater than 0 for at least one of the three ocular regions (upper lid margin, lower lid margin, or cornea).|Mean Difference (Final Values)|-8.2|STANDARD_ERROR_OF_MEAN|4.25|||TWO_SIDED|95.0|-16.7|0.2|||Mixed Models Analysis|||10-Minutes Post Treatment|Mean difference was calculated as (10-min Post-Treatment MINUS Immediate Post-insertion).|0.2|-16.7|
72469174|NCT03733899|144461881|SUPERIORITY|Superiority was concluded if the lower limit of 95% confidence interval was greater than 0.|Mean Difference (Final Values)|1.4|STANDARD_ERROR_OF_MEAN|5.07|||TWO_SIDED|95.0|-8.7|11.6|||Mixed Models Analysis|||10-Minutes Post Treatment|Mean Difference was cacluated as Corneal - Lower Lid Margin|11.6|-8.7|
72469175|NCT03733899|144461881|SUPERIORITY|Superiority was concluded if the lower limit of 95% confidence interval was greater than 0.|Mean Difference (Final Values)|8.5|STANDARD_ERROR_OF_MEAN|4.77|||TWO_SIDED|95.0|-1.0|18.0|||Mixed Models Analysis|||5-Minutes Post Treatment|Mean Difference was cacluated as Corneal - Lower Lid Margin|18.0|-1.0|
72469176|NCT03733899|144461881|SUPERIORITY|Superiority was concluded if the lower limit of 95% confidence interval was greater than 0.|Mean Difference (Final Values)|6.8|STANDARD_ERROR_OF_MEAN|5.12|||TWO_SIDED|95.0|-3.5|17.0|||Mixed Models Analysis|||10-Minutes Post Treatment|Mean Difference was cacluated as Corneal - Upper Lid Margin|17.0|-3.5|
72469177|NCT03733899|144461881|SUPERIORITY|Subjective comfort was analyzed using linear mixed model. Statistical inference was made based on the 95% confidence interval constructed for the least square mean difference.|Mean Difference (Final Values)|11.2|STANDARD_ERROR_OF_MEAN|4.82|||TWO_SIDED|95.0|1.6|20.8|||Mixed Models Analysis|||5-Minutes Post Treatment|Mean Difference was cacluated as Corneal - Upper Lid Margin|20.8|1.6|
72469178|NCT03733899|144461882|SUPERIORITY|Superiority was concluded if the lower limit of 95% confidence interval was greater than 0.|Mean Difference (Final Values)|0.8|STANDARD_ERROR_OF_MEAN|6.12|||TWO_SIDED|95.0|-11.4|12.9|||Mixed Models Analysis|||10-Minutes Post Treatment|Mean Difference was cacluated as Corneal - Lower Lid Margin: 10-mintues post treatment - Pre Treatment.|12.9|-11.4|
72469179|NCT03733899|144461882|SUPERIORITY|Superiority was concluded if the lower limit of 95% confidence interval was greater than 0.|Mean Difference (Final Values)|7.8|STANDARD_ERROR_OF_MEAN|6.1|||TWO_SIDED|95.0|-4.9|19.9|||Mixed Models Analysis|||5-Minutes Post Treatment|Mean Difference was cacluated as Corneal - Lower Lid Margin: 5-mintues post treatment - Pre Treatment.|19.9|-4.9|
72565241|NCT03440424|144662011|OTHER||Percent ratio of geometric mean|78.98|||||TWO_SIDED|90.0|62.88|99.21|||||Percent ratio of geometric mean was calculated by dividing the geometric mean of test by geometric mean of reference, then multiplying the value by 100.|M9 metabolite||99.21|62.88|
72565242|NCT03440424|144662011|OTHER||Percent ratio of geometric mean|63.2|||||TWO_SIDED|90.0|50.31|79.38|||||Percent ratio of geometric mean was calculated by dividing the geometric mean of test by geometric mean of reference, then multiplying the value by 100.|M9 metabolite||79.38|50.31|
72565243|NCT03440424|144662011|OTHER||Percent ratio of geometric mean|94.56|||||TWO_SIDED|90.0|68.5|130.51|||||Percent ratio of geometric mean was calculated by dividing the geometric mean of test by geometric mean of reference, then multiplying the value by 100.|M10 metabolite||130.51|68.50|
72469180|NCT03733899|144461882|SUPERIORITY|Superiority was concluded if the lower limit of 95% confidence interval was greater than 0.|Mean Difference (Final Values)|2.9|STANDARD_ERROR_OF_MEAN|6.19|||TWO_SIDED|95.0|-9.3|15.2|||Mixed Models Analysis|||10-Minutes Post Treatment|Mean Difference was cacluated as Corneal - Upper Lid Margin: 10-mintues post treatment - Pre Treatment.|15.2|-9.3|
72469181|NCT03733899|144461882|SUPERIORITY|Subjective comfort was analyzed using linear mixed model. Statistical inference was made based on the 95% confidence interval constructed for the least square mean difference.|Mean Difference (Final Values)|7.4|STANDARD_ERROR_OF_MEAN|6.17|||TWO_SIDED|95.0|-4.9|19.6|||Mixed Models Analysis|||5-Minutes Post Treatment|Mean Difference was cacluated as Corneal - Upper Lid Margin: 5-mintues post treatment - Pre Treatment.|19.6|-4.9|
72469182|NCT03733899|144461883|SUPERIORITY|Superiority was concluded if the lower limit of 95% confidence interval was greater than 0.|Mean Difference (Final Values)|-12.4|STANDARD_ERROR_OF_MEAN|4.22|||TWO_SIDED|95.0|-20.9|-3.9|||Mixed Models Analysis||||mean difference was calculated as postremoval minus pre-insertion with Test and corneal region.|-3.9|-20.9|
72469183|NCT02035696|144461884|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the Lower limit of the 2-sided 95% CI of the vaccine group GMT ratio ≥ 0.67|Vaccine Group Ratios at Day 1|0.99|||||TWO_SIDED|95.0|0.65|1.52||||||Non-inferiority of immune responses of a TIVc-High Dose to TIVe, assessed in terms of vaccine group GMT ratios against influenza strain A/H1N1 at Day 1||1.52|0.65|
72469184|NCT02035696|144461884|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the Lower limit of the 2-sided 95% CI of the vaccine group GMT ratio ≥ 0.67|Vaccine Group ratios at Day 50|2.11|||||TWO_SIDED|95.0|1.5|2.98||||||Non-inferiority of immune responses of a TIVc-High Dose to TIVe, assessed in terms of vaccine group GMT ratios against influenza strain A/H1N1 at Day 50||2.98|1.5|
72469185|NCT02035696|144461884|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the Lower limit of the 2-sided 95% CI of the vaccine group GMT ratio ≥ 0.67|Vaccine Group ratios at Day 1|0.68|||||TWO_SIDED|95.0|0.43|1.06||||||Non-inferiority of immune responses of a TIVc-High Dose to TIVe, assessed in terms of vaccine group GMT ratios against influenza strain A/H3N2 at Day 1||1.06|0.43|
72469186|NCT02035696|144461884|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the Lower limit of the 2-sided 95% CI of the vaccine group GMT ratio ≥ 0.67|Vaccine Group Ratios at Day 50|0.71|||||TWO_SIDED|95.0|0.58|0.87||||||Non-inferiority of immune responses of a TIVc-High Dose to TIVe, assessed in terms of vaccine group GMT ratios against influenza strain A/H3N2 at Day 50||0.87|0.58|
72469187|NCT02035696|144461884|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the Lower limit of the 2-sided 95% CI of the vaccine group GMT ratio ≥ 0.67|Vaccine Group Ratios at Day 1|1.0|||||TWO_SIDED|95.0|0.92|1.08||||||Non-inferiority of immune responses of a TIVc-High Dose to TIVe, assessed in terms of vaccine group GMT ratios against influenza strain B at Day 1||1.08|0.92|
72469188|NCT02035696|144461884|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the Lower limit of the 2-sided 95% CI of the vaccine group GMT ratio ≥ 0.67|Vaccine Group ratios at Day 50|0.78|||||TWO_SIDED|95.0|0.6|1.01||||||Non-inferiority of immune responses of a TIVc-High Dose to TIVe, assessed in terms of vaccine group GMT ratios against influenza strain B at Day 50||1.01|0.6|
72469189|NCT02035696|144461884|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the Lower limit of the 2-sided 95% CI of the vaccine group GMT ratio ≥ 0.67|Vaccine Group Ratios at Day 1|1.27|||||TWO_SIDED|95.0|0.83|1.96||||||Non-inferiority of immune responses of a TIVc-Full Dose to TIVe, assessed in terms of vaccine group GMT ratios against influenza strain A/H1N1 at Day 1||1.96|0.83|
72469190|NCT02035696|144461884|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the Lower limit of the 2-sided 95% CI of the vaccine group GMT ratio ≥ 0.67|Vaccine Group Ratios at Day 50|1.6|||||TWO_SIDED|95.0|1.13|2.28||||||Non-inferiority of immune responses of a TIVc-Full Dose to TIVe, assessed in terms of vaccine group GMT ratios against influenza strain A/H1N1 at Day 50||2.28|1.13|
72469191|NCT02035696|144461884|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the Lower limit of the 2-sided 95% CI of the vaccine group GMT ratio ≥ 0.67|Vaccine Group Ratios at Day 1|0.52|||||TWO_SIDED|95.0|0.33|0.81||||||Non-inferiority of immune responses of a TIVc-Full Dose to TIVe, assessed in terms of vaccine group GMT ratios against influenza strain A/H3N2 at Day 1||0.81|0.33|
72469192|NCT02035696|144461884|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the Lower limit of the 2-sided 95% CI of the vaccine group GMT ratio ≥ 0.67|Vaccine Group Ratios at Day 50|0.64|||||TWO_SIDED|95.0|0.52|0.78||||||Non-inferiority of immune responses of a TIVc-Full Dose to TIVe, assessed in terms of vaccine group GMT ratios against influenza strain A/H3N2 at Day 50||0.78|0.52|
72469193|NCT02035696|144461884|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the Lower limit of the 2-sided 95% CI of the vaccine group GMT ratio ≥ 0.67|Vaccine Group ratios at Day 1|0.96|||||TWO_SIDED|95.0|0.89|1.04||||||Non-inferiority of immune responses of a TIVc-Full Dose to TIVe, assessed in terms of vaccine group GMT ratios against influenza strain B at Day 1||1.04|0.89|
72469194|NCT02035696|144461884|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the Lower limit of the 2-sided 95% CI of the vaccine group GMT ratio ≥ 0.67|Vaccine Group Ratios at Day 50|0.64|||||TWO_SIDED|95.0|0.49|0.84||||||Non-inferiority of immune responses of a TIVc-Full Dose to TIVe, assessed in terms of vaccine group GMT ratios against influenza strain B at Day 50||0.84|0.49|
72395009|NCT04853225|144296588|OTHER||Adjusted rate of change|-50.32|||||||||||||Post-bronchodilator. Adjusted rate of change was analyzed using Random Coefficient Model. The model was fitted with an unstructured variance-covariance matrix.|||||
72469195|NCT02035696|144461884|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the Lower limit of the 2-sided 95% CI of the vaccine group GMT ratio ≥ 0.67|Vaccine Group Ratios at Day 1|1.02|||||TWO_SIDED|95.0|0.66|1.58||||||Non-inferiority of immune responses of a TIVc- Half Dose to TIVe, assessed in terms of vaccine group GMT ratios against influenza strain A/H1N1 at Day 1||1.58|0.66|
72469196|NCT02035696|144461884|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the Lower limit of the 2-sided 95% CI of the vaccine group GMT ratio ≥ 0.67|Vaccine Group ratios at Day 50|1.62|||||TWO_SIDED|95.0|1.14|2.3||||||Non-inferiority of immune responses of a TIVc- Half Dose to TIVe, assessed in terms of vaccine group GMT ratios against influenza strain A/H1N1 at Day 50||2.3|1.14|
72469197|NCT02035696|144461884|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the Lower limit of the 2-sided 95% CI of the vaccine group GMT ratio ≥ 0.67|Vaccine Group Ratios at Day 1|0.74|||||TWO_SIDED|95.0|0.47|1.17||||||Non-inferiority of immune responses of a TIVc- Half Dose to TIVe, assessed in terms of vaccine group GMT ratios against influenza strain A/H3N2 at Day 1||1.17|0.47|
72469198|NCT02035696|144461884|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the Lower limit of the 2-sided 95% CI of the vaccine group GMT ratio ≥ 0.67|Vaccine Group ratios at Day 50|0.46|||||TWO_SIDED|95.0|0.38|0.57||||||Non-inferiority of immune responses of a TIVc- Half Dose to TIVe, assessed in terms of vaccine group GMT ratios against influenza strain A/H3N2 at Day 50||0.57|0.38|
72469199|NCT02035696|144461884|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the Lower limit of the 2-sided 95% CI of the vaccine group GMT ratio ≥ 0.67|Vaccine Group Ratios at Day 1|0.94|||||TWO_SIDED|95.0|0.87|1.02||||||Non-inferiority of immune responses of a TIVc- Half Dose to TIVe, assessed in terms of vaccine group GMT ratios against influenza strain B at Day 1||1.02|0.87|
72469200|NCT02035696|144461884|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the Lower limit of the 2-sided 95% CI of the vaccine group GMT ratio ≥ 0.67|Vaccine Group Ratios at Day 50|0.57|||||TWO_SIDED|95.0|0.44|0.75||||||Non-inferiority of immune responses of a TIVc- Half Dose to TIVe, assessed in terms of vaccine group GMT ratios against influenza strain B at Day 50||0.75|0.44|
72504377|NCT00995371|144539349|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.52|||<|0.05|TWO_SIDED|95.0|1.09|3.96|||t-test, 2 sided|||The mean change from baseline was assessed for VAS using a paired t-test. The resulting p-values are to be considered as descriptive statistics. Two-sided test with 5% Type I error was used.||3.96|1.09|<0.05
72504378|NCT00995371|144539349|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.06|||>|0.05|TWO_SIDED|95.0|-1.43|1.55|||t-test, 2 sided|||The mean change from baseline was assessed for VAS using a paired t-test. The resulting p-values are to be considered as descriptive statistics. Two-sided test with 5% Type I error was used.||1.55|-1.43|>0.05
72504379|NCT00995371|144539350|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.33|||<|0.05|TWO_SIDED|95.0|3.35|19.31|||t-test, 2 sided|||The mean change from baseline was assessed for ODI using a paired t-test. The resulting p-values are to be considered as descriptive statistics. Two-sided test with 5% Type I error was used.||19.31|3.35|<0.05
72565244|NCT03440424|144662011|OTHER||Percent ratio of geometric mean|71.81|||||TWO_SIDED|90.0|52.03|99.12|||||Percent ratio of geometric mean was calculated by dividing the geometric mean of test by geometric mean of reference, then multiplying the value by 100.|M10 metabolite||99.12|52.03|
72565245|NCT03440424|144662012|OTHER||Percent ratio of geometric mean|106.7|||||TWO_SIDED|90.0|83.95|135.62|||||Percent ratio of geometric mean was calculated by dividing the geometric mean of test by geometric mean of reference, then multiplying the value by 100.|M4 metabolite||135.62|83.95|
72565246|NCT03440424|144662012|OTHER||Percent ratio of geometric mean|85.68|||||TWO_SIDED|90.0|67.41|108.9|||||Percent ratio of geometric mean was calculated by dividing the geometric mean of test by geometric mean of reference, then multiplying the value by 100.|M4 metabolite||108.90|67.41|
72565247|NCT03440424|144662012|OTHER||Percent ratio of geometric mean|75.41|||||TWO_SIDED|90.0|62.28|91.31|||||Percent ratio of geometric mean was calculated by dividing the geometric mean of test by geometric mean of reference, then multiplying the value by 100.|M9 metabolite||91.31|62.28|
72565248|NCT03440424|144662012|OTHER||Percent ratio of geometric mean|76.0|||||TWO_SIDED|90.0|62.76|92.02|||||Percent ratio of geometric mean was calculated by dividing the geometric mean of test by geometric mean of reference, then multiplying the value by 100.|M9 metabolite||92.02|62.76|
72565249|NCT03440424|144662012|OTHER||Percent ratio of geometric mean|95.55|||||TWO_SIDED|90.0|71.92|126.94|||||Percent ratio of geometric mean was calculated by dividing the geometric mean of test by geometric mean of reference, then multiplying the value by 100.|M10 metabolite||126.94|71.92|
72565250|NCT03440424|144662012|OTHER||Percent ratio of geometric mean|74.48|||||TWO_SIDED|90.0|56.06|98.94|||||Percent ratio of geometric mean was calculated by dividing the geometric mean of test by geometric mean of reference, then multiplying the value by 100.|M10 metabolite||98.94|56.06|
72565251|NCT03440424|144662013|OTHER||Percent ratio of geometric mean|113.04|||||TWO_SIDED|90.0|85.16|150.05|||||Percent ratio of geometric mean was calculated by dividing the geometric mean of test by geometric mean of reference, then multiplying the value by 100.|M4 metabolite||150.05|85.16|
72565252|NCT03440424|144662013|OTHER||Percent ratio of geometric mean|103.74|||||TWO_SIDED|90.0|78.16|137.7|||||Percent ratio of geometric mean was calculated by dividing the geometric mean of test by geometric mean of reference, then multiplying the value by 100.|M4 metabolite||137.70|78.16|
72565253|NCT03440424|144662013|OTHER||Percent ratio of geometric mean|78.62|||||TWO_SIDED|90.0|62.57|98.78|||||Percent ratio of geometric mean was calculated by dividing the geometric mean of test by geometric mean of reference, then multiplying the value by 100.|M9 metabolite||98.78|62.57|
72469201|NCT02035696|144461885|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the Lower limit of the 2-sided 95% CI on the difference between seroconversion rates ≥ -10%|Vaccine Group Differences|10.0|||||TWO_SIDED|95.0|0.0|18.9||||||Non-inferiority of immune responses of TIVc-High Dose to TIVe, assessed in terms of Vaccine Group Differences with seroconversion against influenza strain A/H1N1||18.9|0|
72469202|NCT02035696|144461885|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the Lower limit of the 2-sided 95% CI on the difference between seroconversion rates ≥ -10%|Vaccine Group Differences|2.0|||||TWO_SIDED|95.0|-4.0|8.0||||||Non-inferiority of immune responses of TIVc-High Dose to TIVe, assessed in terms of Vaccine Group Differences with seroconversion against influenza strain A/H3N2||8|-4|
72469203|NCT02035696|144461885|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the Lower limit of the 2-sided 95% CI on the difference between seroconversion rates ≥ -10%|Vaccine Group differences|-11.0|||||TWO_SIDED|95.0|-21.1|-1.5||||||Non-inferiority of immune responses of TIVc-High Dose to TIVe, assessed in terms of Vaccine Group Differences with seroconversion against influenza strain B||-1.5|-21.1|
72469204|NCT02035696|144461885|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the Lower limit of the 2-sided 95% CI on the difference between seroconversion rates ≥ -10%|Vaccine Group Differences|7.0|||||TWO_SIDED|95.0|-2.5|16.8||||||Non-inferiority of immune responses of TIVc-Full Dose to TIVe, assessed in terms of Vaccine Group Differences with seroconversion against influenza strain A/H1N1||16.8|-2.5|
72469205|NCT02035696|144461885|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the Lower limit of the 2-sided 95% CI on the difference between seroconversion rates ≥ -10%|Vaccine Group differences|-3.0|||||TWO_SIDED|95.0|-9.5|4.1||||||Non-inferiority of immune responses of TIVc-Full Dose to TIVe, assessed in terms of Vaccine Group Differences with seroconversion against influenza strain A/H3N2||4.1|-9.5|
72565254|NCT03440424|144662013|OTHER||Percent ratio of geometric mean|101.0|||||TWO_SIDED|90.0|80.38|126.9|||||Percent ratio of geometric mean was calculated by dividing the geometric mean of test by geometric mean of reference, then multiplying the value by 100.|M9 metabolite||126.90|80.38|
72565255|NCT03440424|144662013|OTHER||Percent ratio of geometric mean|109.49|||||TWO_SIDED|90.0|81.07|147.88|||||Percent ratio of geometric mean was calculated by dividing the geometric mean of test by geometric mean of reference, then multiplying the value by 100.|M10 metabolite||147.88|81.07|
72565256|NCT03440424|144662013|OTHER||Percent ratio of geometric mean|105.2|||||TWO_SIDED|90.0|77.89|142.08|||||Percent ratio of geometric mean was calculated by dividing the geometric mean of test by geometric mean of reference, then multiplying the value by 100.|M10 metabolite||142.08|77.89|
72565257|NCT03440424|144662014|OTHER||Percent ratio of geometric mean|115.38|||||TWO_SIDED|90.0|83.51|159.42|||||Percent ratio of geometric mean was calculated by dividing the geometric mean of test by geometric mean of reference, then multiplying the value by 100.|M4 metabolite||159.42|83.51|
72565258|NCT03440424|144662014|OTHER||Percent ratio of geometric mean|116.97|||||TWO_SIDED|90.0|84.66|161.62|||||Percent ratio of geometric mean was calculated by dividing the geometric mean of test by geometric mean of reference, then multiplying the value by 100.|M4 metabolite||161.62|84.66|
72565259|NCT03440424|144662014|OTHER||Percent ratio of geometric mean|78.46|||||TWO_SIDED|90.0|61.06|100.81|||||Percent ratio of geometric mean was calculated by dividing the geometric mean of test by geometric mean of reference, then multiplying the value by 100.|M9 metabolite||100.81|61.06|
72565260|NCT03440424|144662014|OTHER||Percent ratio of geometric mean|116.76|||||TWO_SIDED|90.0|89.95|151.56|||||Percent ratio of geometric mean was calculated by dividing the geometric mean of test by geometric mean of reference, then multiplying the value by 100.|M9 metabolite||151.56|89.95|
72622122|NCT04003142|144774325|SUPERIORITY||Odds Ratio (OR)|2.367|||<|0.001||95.0|1.502|3.762||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 3||3.762|1.502|<0.001
72395010|NCT04853225|144296588|OTHER||Adjusted rate of change|-22.67|||||||||||||Pre-bronchodilator. Adjusted rate of change was analyzed using Random Coefficient Model. The model was fitted with an unstructured variance-covariance matrix.|||||
72469206|NCT02035696|144461885|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the Lower limit of the 2-sided 95% CI on the difference between seroconversion rates ≥ -10%|Vaccine Group Differences|-11.0|||||TWO_SIDED|95.0|-20.5|-1.0||||||Non-inferiority of immune responses of TIVc-Full Dose to TIVe, assessed in terms of Vaccine Group Differences with seroconversion against influenza strain B||-1|-20.5|
72469207|NCT02035696|144461885|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the Lower limit of the 2-sided 95% CI on the difference between seroconversion rates ≥ -10%|Vaccine Group Differences|6.0|||||TWO_SIDED|95.0|-4.2|15.4||||||Non-inferiority of immune responses of TIVc- Half Dose to TIVe, assessed in terms of Vaccine Group Differences with seroconversion against influenza strain A/H1N1||15.4|-4.2|
72469208|NCT02035696|144461885|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the Lower limit of the 2-sided 95% CI on the difference between seroconversion rates ≥ -10%|Vaccine Group Differences|-6.0|||||TWO_SIDED|95.0|-13.4|1.3||||||Non-inferiority of immune responses of TIVc- Half Dose to TIVe, assessed in terms of Vaccine Group Differences with seroconversion against influenza strain A/H3N2||1.3|-13.4|
72469209|NCT02035696|144461885|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the Lower limit of the 2-sided 95% CI on the difference between seroconversion rates ≥ -10%|Vaccine Group Differences|-18.0|||||TWO_SIDED|95.0|-27.8|-7.2||||||Non-inferiority of immune responses of TIVc- Half Dose to TIVe, assessed in terms of Vaccine Group Differences with seroconversion against influenza strain B||-7.2|-27.8|
72469210|NCT02035696|144461886|SUPERIORITY_OR_OTHER||Desirability Index Score|0.0|||||TWO_SIDED||||||||Desirability Score: If this difference is negative, then it is defined as non-desirable (D equal to 0), while if the difference is positive, then D will equal to the relative reduction calculated in the following way: D = (TIVe - TIVc Dose )/TIVe.|||||
72469211|NCT02035696|144461886|SUPERIORITY_OR_OTHER||Desirability Index Score|0.0|||||TWO_SIDED||||||||Desirability Score: If this difference is negative, then it is defined as non-desirable (D equal to 0), while if the difference is positive, then D will equal to the relative reduction calculated in the following way: D = (TIVe - TIVc Dose )/TIVe.|||||
72469212|NCT02035696|144461886|SUPERIORITY_OR_OTHER||Desirability Index Score|0.0|||||TWO_SIDED||||||||Desirability Score: If this difference is negative, then it is defined as non-desirable (D equal to 0), while if the difference is positive, then D will equal to the relative reduction calculated in the following way: D = (TIVe - TIVc Dose )/TIVe.|||||
72565261|NCT03440424|144662014|OTHER||Percent ratio of geometric mean|94.97|||||TWO_SIDED|90.0|70.31|128.28|||||Percent ratio of geometric mean was calculated by dividing the geometric mean of test by geometric mean of reference, then multiplying the value by 100.|M10 metabolite||128.28|70.31|
72565262|NCT03440424|144662014|OTHER||Percent ratio of geometric mean|103.59|||||TWO_SIDED|90.0|75.43|142.28|||||Percent ratio of geometric mean was calculated by dividing the geometric mean of test by geometric mean of reference, then multiplying the value by 100.|M10 metabolite||142.28|75.43|
72622123|NCT04003142|144774325|SUPERIORITY||Odds Ratio (OR)|2.894|||<|0.001||95.0|1.835|4.609||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 3||4.609|1.835|<0.001
72622124|NCT04003142|144774325|SUPERIORITY||Odds Ratio (OR)|2.902|||<|0.001|TWO_SIDED|95.0|1.829|4.657||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 4||4.657|1.829|<0.001
72622125|NCT04003142|144774325|SUPERIORITY||Odds Ratio (OR)|3.218|||<|0.001||95.0|2.025|5.172||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 4||5.172|2.025|<0.001
72622126|NCT04003142|144774325|SUPERIORITY||Odds Ratio (OR)|2.153|||<|0.001||95.0|1.375|3.394||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 5||3.394|1.375|<0.001
72622127|NCT04003142|144774325|SUPERIORITY||Odds Ratio (OR)|3.074|||<|0.001||95.0|1.957|4.878||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 5||4.878|1.957|<0.001
72622128|NCT04003142|144774325|SUPERIORITY||Odds Ratio (OR)|2.05||||0.002||95.0|1.31|3.228||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 6||3.228|1.310|0.002
72622129|NCT04003142|144774325|SUPERIORITY||Odds Ratio (OR)|2.908|||<|0.001||95.0|1.856|4.599||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 6||4.599|1.856|<0.001
72469213|NCT00379769|144461916|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin of 1.2 for the upper limit of the 95 percent confidence interval in time to event analysis comparing RSG to MET/SU stratified by background medication|Hazard Ratio (HR)|0.99||||||95.0|0.85|1.16||||||||1.16|0.85|
72469214|NCT00379769|144461940|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.86||||||95.0|0.68|1.08||||||||1.08|0.68|
72469215|NCT00379769|144461941|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.95||||||95.0|0.78|1.17||||||||1.17|0.78|
72469216|NCT00379769|144461942|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.97||||||95.0|0.79|1.18||||||||1.18|0.79|
72469217|NCT00379769|144461943|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.9||||||95.0|0.68|1.21||||||||1.21|0.68|
72469218|NCT00379769|144461944|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.9||||||95.0|0.68|1.21||||||||1.21|0.68|
72469219|NCT00379769|144461945|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.13||||||95.0|0.8|1.59||||||||1.59|0.80|
72469220|NCT00379769|144461946|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.15||||||95.0|0.82|1.62||||||||1.62|0.82|
72469221|NCT00379769|144461947|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.79||||||95.0|0.54|1.14||||||||1.14|0.54|
72469222|NCT00379769|144461948|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.82||||||95.0|0.57|1.18||||||||1.18|0.57|
72469223|NCT01536587|144462024|SUPERIORITY_OR_OTHER|||||||0.5062||95.0|||||paired t-Test, 2-sided|||||||0.5062
72469224|NCT03382561|144462072|SUPERIORITY||Hazard Ratio (HR)|0.78||||0.17|TWO_SIDED|95.0|0.55|1.11|||Log Rank||Hazard ratio: Arm A (CEN)/Arm B (CE)|||1.11|0.55|0.17
72469225|NCT01150045|144462111|SUPERIORITY||Hazard Ratio (HR)|0.89||||0.12|TWO_SIDED|95.0|0.76|1.03|||Log Rank|||||1.03|0.76|0.12
72469226|NCT02431052|144462114|OTHER|||||||0.0006|||||||Cochran-Mantel-Haenszel|ANCOVA with factors of treatment group (combined vehicle as one group) and baseline count as covariate.||||||0.0006
72565263|NCT03702049|144662022|OTHER|Change in score at 3 months|Mean Difference (Final Values)|-0.24||||0.603|TWO_SIDED||||||Mixed Models Analysis|||Change in score at 3 months||||0.603
72565264|NCT03702049|144662022|OTHER|Change at 6 months|Mean Difference (Final Values)|-0.12||||0.805|TWO_SIDED||||||Mixed Models Analysis|||6 month outcome||||0.805
72565265|NCT03702049|144662023|OTHER||Odds Ratio (OR)|0.83||||0.672|TWO_SIDED|95.0|0.39|1.79|||Regression, Logistic|||3 month outcome||1.79|0.39|0.672
72565266|NCT03702049|144662023|OTHER||Odds Ratio (OR)|0.49||||0.165|TWO_SIDED|95.0|0.18|1.34|||Regression, Logistic|||6 month outcome||1.34|0.18|0.165
72565267|NCT03702049|144662024|OTHER||Mean Difference (Final Values)|-0.31||||0.719|TWO_SIDED||||||Mixed Models Analysis|||3 month outcome||||0.719
72469227|NCT02431052|144462115|OTHER|||||||0.0002|||||||Cochran-Mantel-Haenszel|ANCOVA with factors of treatment group (combined vehicle as one group) and baseline count as covariate.||||||0.0002
72469228|NCT02431052|144462116|OTHER|||||||0.0055|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test (vehicle treatment groups included as single combined treatment group).||||||0.0055
72469229|NCT02094898|144462117|SUPERIORITY||||||<|0.01|||||||t-test, 2 sided|||alpha level of 0.05.||||<0.01
72469230|NCT02094898|144462117|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|||alpha level of 0.05.||||<0.05
72469231|NCT02094898|144462118|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||alpha level of 0.05.||||<0.001
72469232|NCT02094898|144462119|SUPERIORITY||||||<|0.01|||||||t-test, 2 sided|||alpha level of 0.05.||||<0.01
72565268|NCT03702049|144662024|OTHER||Mean Difference (Final Values)|0.43||||0.626|TWO_SIDED||||||Mixed Models Analysis|||6 month outcome||||0.626
72565269|NCT03702049|144662025|OTHER||Mean Difference (Final Values)|0.83||||0.1668|TWO_SIDED|95.0|-0.36|2.03|||t-test, 2 sided|||||2.03|-0.36|0.1668
72565270|NCT03702049|144662026|OTHER||Mean Difference (Final Values)|1.5||||0.9198|TWO_SIDED|95.0|-29.6|32.7|||t-test, 2 sided|||3 month outcome||32.7|-29.6|0.9198
72565271|NCT03702049|144662026|OTHER||Mean Difference (Final Values)|12.5||||0.5015|TWO_SIDED|95.0|-25.6|50.7|||t-test, 2 sided|||6 month||50.7|-25.6|0.5015
72565272|NCT02129647|144662029|OTHER||||||||||||||||||10 tissue matched historical controls were analyzed. The Median (Full Range) of the histoscore was 122 (60 to 265)|||
72395011|NCT04853225|144296588|OTHER||Adjusted rate of change|-33.32|||||||||||||Post-bronchodilator. Adjusted rate of change was analyzed using Random Coefficient Model. The model was fitted with an unstructured variance-covariance matrix.|||||
72395012|NCT04853225|144296588|OTHER||Adjusted rate of change|-20.4|||||||||||||Pre-bronchodilator. Adjusted rate of change was analyzed using Random Coefficient Model. The model was fitted with an unstructured variance-covariance matrix.|||||
72395013|NCT04853225|144296588|OTHER||Adjusted rate of change|-31.08|||||||||||||Post-bronchodilator. Adjusted rate of change was analyzed using Random Coefficient Model. The model was fitted with an unstructured variance-covariance matrix.|||||
72395014|NCT04853225|144296588|OTHER||Adjusted rate of change|-64.74|||||||||||||Pre-bronchodilator. Adjusted rate of change was analyzed using Random Coefficient Model. The model was fitted with an unstructured variance-covariance matrix.|||||
72395015|NCT04853225|144296588|OTHER||Adjusted rate of change|-60.26|||||||||||||Post-bronchodilator. Adjusted rate of change was analyzed using Random Coefficient Model. The model was fitted with an unstructured variance-covariance matrix.|||||
72395016|NCT04853225|144296588|OTHER||Adjusted rate of change|-27.85|||||||||||||Pre-bronchodilator. Adjusted rate of change was analyzed using Random Coefficient Model. The model was fitted with an unstructured variance-covariance matrix.|||||
72395017|NCT04853225|144296588|OTHER||Adjusted rate of change|-28.65|||||||||||||Post-bronchodilator. Adjusted rate of change was analyzed using Random Coefficient Model. The model was fitted with an unstructured variance-covariance matrix.|||||
72395018|NCT04853225|144296589|OTHER||Adjusted rate of change|-87.47|||||||||||||Pre-bronchodilator. Adjusted rate of change was analyzed using Random Coefficient Model. The model was fitted with an unstructured variance-covariance matrix.|||||
72395019|NCT04853225|144296589|OTHER||Adjusted rate of change|-83.25|||||||||||||Post-bronchodilator. Adjusted rate of change was analyzed using Random Coefficient Model. The model was fitted with an unstructured variance-covariance matrix.|||||
72469233|NCT02094898|144462119|SUPERIORITY||||||<|0.01|||||||t-test, 2 sided|||alpha level of 0.05.||||<0.01
72469234|NCT02094898|144462119|SUPERIORITY||||||<|0.08|||||||t-test, 2 sided|||alpha level of 0.05.||||<0.08
72469235|NCT02094898|144462120|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||alpha level of 0.05.||||<0.001
72565273|NCT02129647|144662030|OTHER||||||||||||||||||10 tissue matched historical controls were analyzed. The Median (Full Range) of the histoscore was 135 (100 to 240)|||
72395020|NCT04853225|144296589|OTHER||Adjusted rate of change|-77.54|||||||||||||Pre-bronchodilator. Adjusted rate of change was analyzed using Random Coefficient Model. The model was fitted with an unstructured variance-covariance matrix.|||||
72395021|NCT04853225|144296589|OTHER||Adjusted rate of change|-77.41|||||||||||||Post-bronchodilator. Adjusted rate of change was analyzed using Random Coefficient Model. The model was fitted with an unstructured variance-covariance matrix.|||||
72395022|NCT04853225|144296589|OTHER||Adjusted rate of change|-60.1|||||||||||||Pre-bronchodilator. Adjusted rate of change was analyzed using Random Coefficient Model. The model was fitted with an unstructured variance-covariance matrix.|||||
72395023|NCT04853225|144296589|OTHER||Adjusted rate of change|-73.65|||||||||||||Post-bronchodilator. Adjusted rate of change was analyzed using Random Coefficient Model. The model was fitted with an unstructured variance-covariance matrix.|||||
72395024|NCT04853225|144296589|OTHER||Adjusted rate of change|-45.44|||||||||||||Pre-bronchodilator. Adjusted rate of change was analyzed using Random Coefficient Model. The model was fitted with an unstructured variance-covariance matrix.|||||
72395025|NCT04853225|144296589|OTHER||Adjusted rate of change|-79.49|||||||||||||Post-bronchodilator. Adjusted rate of change was analyzed using Random Coefficient Model. The model was fitted with an unstructured variance-covariance matrix.|||||
72395026|NCT04853225|144296589|OTHER||Adjusted rate of change|-74.39|||||||||||||Pre-bronchodilator. Adjusted rate of change was analyzed using Random Coefficient Model. The model was fitted with an unstructured variance-covariance matrix.|||||
72395027|NCT04853225|144296589|OTHER||Adjusted rate of change|-63.04|||||||||||||Post-bronchodilator. Adjusted rate of change was analyzed using Random Coefficient Model. The model was fitted with an unstructured variance-covariance matrix.|||||
72395028|NCT04853225|144296589|OTHER||Adjusted rate of change|-25.59|||||||||||||Pre-bronchodilator. Adjusted rate of change was analyzed using Random Coefficient Model. The model was fitted with an unstructured variance-covariance matrix.|||||
72395029|NCT04853225|144296589|OTHER||Adjusted rate of change|-38.69|||||||||||||Post-bronchodilator. Adjusted rate of change was analyzed using Random Coefficient Model. The model was fitted with an unstructured variance-covariance matrix.|||||
72395030|NCT02700815|144296590|SUPERIORITY||Mean Difference (Net)|-0.6|STANDARD_ERROR_OF_MEAN|0.277||0.0303|TWO_SIDED|95.0|-1.15|-0.06|||Mixed Models Analysis||The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|A Mixed Model Repeat Measures (MMRM) analysis was used to compare change in POMwp from baseline between placebo and combination therapy diclofenac + capsaicin. MMRM model included fixed effects of treatment, country, application site (back/neck), time and fixed covariates of baseline POMwp and baseline POMwp by time interaction.||-0.06|-1.15|0.0303
72469236|NCT02094898|144462121|SUPERIORITY||||||<|0.01|||||||t-test, 2 sided|||alpha level of 0.05.||||<0.01
72469237|NCT02094898|144462121|SUPERIORITY||||||<|0.08|||||||t-test, 2 sided|||alpha level of 0.05.||||<0.08
72469238|NCT02094898|144462122|SUPERIORITY||||||<|0.01|||||||t-test, 2 sided|||alpha level of 0.05.||||<0.01
72469239|NCT02094898|144462123|SUPERIORITY||||||<|0.01|||||||t-test, 2 sided|||alpha level of 0.05.||||<0.01
72469240|NCT02094898|144462123|SUPERIORITY||||||<|0.01|||||||t-test, 2 sided|||alpha level of 0.05.||||<0.01
72469241|NCT02094898|144462124|SUPERIORITY||||||<|0.01|||||||t-test, 2 sided|||alpha level of 0.05.||||<0.01
72469242|NCT02094898|144462125|SUPERIORITY||||||<|0.08|||||||t-test, 2 sided|||alpha level of 0.05.||||<0.08
72469243|NCT02094898|144462125|SUPERIORITY||||||<|0.08|||||||t-test, 2 sided|||alpha level of 0.05.||||<0.08
72469244|NCT02094898|144462126|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||alpha level of 0.05.||||<0.001
72469245|NCT02094898|144462127|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|||alpha level of 0.05.||||<0.05
72469246|NCT02094898|144462127|SUPERIORITY||||||<|0.08|||||||t-test, 2 sided|||alpha level of 0.05.||||<0.08
72565274|NCT02129647|144662031|OTHER||||||||||||||||||10 tissue matched historical controls were analyzed. The Median (Full Range) of the histoscore was 12 (0 to 100)|||
72395031|NCT02700815|144296590|SUPERIORITY||Mean Difference (Net)|0.21|STANDARD_ERROR_OF_MEAN|0.197||0.2886|TWO_SIDED|95.0|-0.18|0.6|||Mixed Models Analysis||The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|A Mixed Model Repeat Measures (MMRM) analysis was used to compare change in POMwp from baseline between capsaicin and combination therapy diclofenac + capsaicin. MMRM model included fixed effects of treatment, country, application site (back/neck), time and fixed covariates of baseline POMwp and baseline POMwp by time interaction.||0.60|-0.18|0.2886
72395032|NCT02700815|144296590|SUPERIORITY||Mean Difference (Net)|-0.72|STANDARD_ERROR_OF_MEAN|0.197||0.0003|TWO_SIDED|95.0|-1.1|-0.33|||Mixed Models Analysis||The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|A Mixed Model Repeat Measures (MMRM) analysis was used to compare change in POMwp from baseline between diclofenac and combination therapy diclofenac + capsaicin. MMRM model included fixed effects of treatment, country, application site (back/neck), time and fixed covariates of baseline POMwp and baseline POMwp by time interaction.||-0.33|-1.10|0.0003
72395033|NCT02700815|144296591|SUPERIORITY||Mean Difference (Net)|-0.37|STANDARD_ERROR_OF_MEAN|0.221||0.0956|TWO_SIDED|95.0|-0.8|0.07|||ANCOVA|ANCOVA includes treatment, country, and application site (back/neck) as fixed effects, and baseline POMwp as a continuous covariate.|The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|An analysis of covariance (ANCOVA) was used to compare POMwp AUC(0-72 h) between placebo and combination therapy diclofenac + capsaicin||0.07|-0.80|0.0956
72395034|NCT02700815|144296591|SUPERIORITY||Mean Difference (Net)|0.3|STANDARD_ERROR_OF_MEAN|0.157||0.0564|TWO_SIDED|95.0|-0.01|0.61|||ANCOVA|ANCOVA includes treatment, country, and application site (back/neck) as fixed effects, and baseline POMwp as a continuous covariate.|The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|An analysis of covariance (ANCOVA) was used to compare POMwp AUC(0-72 h) between capsaicin and combination therapy diclofenac + capsaicin||0.61|-0.01|0.0564
72395035|NCT02700815|144296591|SUPERIORITY||Mean Difference (Net)|-0.56|STANDARD_ERROR_OF_MEAN|0.157||0.0004|TWO_SIDED|95.0|-0.87|-0.25|||ANCOVA|ANCOVA includes treatment, country, and application site (back/neck) as fixed effects, and baseline POMwp as a continuous covariate.|The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|An analysis of covariance (ANCOVA) was used to compare POMwp AUC(0-72 h) between diclofenac and combination therapy diclofenac + capsaicin||-0.25|-0.87|0.0004
72469247|NCT02094898|144462128|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||alpha level of 0.05.||||<0.001
72469248|NCT02094898|144462129|SUPERIORITY||||||<|0.01|||||||t-test, 2 sided|||alpha level of 0.05.||||<0.01
72469249|NCT02094898|144462129|SUPERIORITY||||||<|0.01|||||||t-test, 2 sided|||alpha level of 0.05.||||<0.01
72469250|NCT03520075|144462141|SUPERIORITY||Geometric Least Squares Mean (Geo LSM)|27.8|||||TWO_SIDED|90.0|8.5|91.2|||||Ratio of Geo LSM was calculated for Cohort 6 (fed state) and Cohort 9 (fasted state) treatment arm groups of 80 mg ASTX029.|Comparison of effect of food on AUC0-24 between Cohort 6 (fed state) and Cohort 9 (fasted state) treatment arm groups of 80 mg ASTX029 in C1D1.||91.2|8.50|
72469251|NCT03520075|144462141|SUPERIORITY||Geo LSM|38.8|||||TWO_SIDED|90.0|11.4|132.0|||||Ratio of Geo LSM was calculated for Cohort 6 (fed state) and Cohort 9 (fasted state) treatment arm groups of 80 mg ASTX029.|Comparison of effect of food on AUC0-24 between Cohort 6 (fed state) and Cohort 9 (fasted state) treatment arm groups of 80 mg ASTX029 in C2D1.||132|11.4|
72469252|NCT03520075|144462141|SUPERIORITY||Geo LSM|58.9|||||TWO_SIDED|90.0|15.7|222.0|||||Ratio of Geo LSM was calculated for Cohort 7 (fed state) and Cohort 10 (fasted state) treatment arm groups of 120 mg ASTX029.|Comparison of effect of food on AUC0-24 between Cohort 7 (fed state) and Cohort 10 (fasted state) treatment arm groups of 120 mg ASTX029 in C1D1.||222|15.7|
72469253|NCT03520075|144462141|SUPERIORITY||Geo LSM|47.2|||||TWO_SIDED|90.0|20.7|108.0|||||Ratio of Geo LSM was calculated for Cohort 7 (fed state) and Cohort 10 (fasted state) treatment arm groups of 120 mg ASTX029.|Comparison of effect of food on AUC0-24 between Cohort 7 (fed state) and Cohort 10 (fasted state) treatment arm groups of 120 mg ASTX029 in C2D1.||108|20.7|
72469254|NCT03520075|144462142|SUPERIORITY||Geo LSM|18.1|||||TWO_SIDED|90.0|5.28|61.9|||||Ratio of Geo LSM was calculated for Cohort 6 (fed state) and Cohort 9 (fasted state) treatment arm groups of 80 mg ASTX029.|Comparison of effect of food on AUC0-inf between Cohort 6 (fed state) and Cohort 9 (fasted state) treatment arm groups of 80 mg ASTX029 in C1D1.||61.9|5.28|
72469255|NCT03520075|144462142|SUPERIORITY||Geo LSM|44.1|||||TWO_SIDED|90.0|8.32|234.0|||||Ratio of Geo LSM was calculated for Cohort 6 (fed state) and Cohort 9 (fasted state) treatment arm groups of 80 mg ASTX029.|Comparison of effect of food on AUC0-inf between Cohort 6 (fed state) and Cohort 9 (fasted state) treatment arm groups of 80 mg ASTX029 in C2D1.||234|8.32|
72469256|NCT03520075|144462142|SUPERIORITY||Geo LSM|58.7|||||TWO_SIDED|90.0|15.7|220.0|||||Ratio of Geo LSM was calculated for Cohort 7 (fed state) and Cohort 10 (fasted state) treatment arm groups of 120 mg ASTX029.|Comparison of effect of food on AUC0-inf between Cohort 7 (fed state) and Cohort 10 (fasted state) treatment arm groups of 120 mg ASTX029 in C1D1.||220|15.7|
72469257|NCT03520075|144462142|SUPERIORITY||Geo LSM|40.2|||||TWO_SIDED|90.0|14.3|113.0|||||Ratio of Geo LSM was calculated for Cohort 7 (fed state) and Cohort 10 (fasted state) treatment arm groups of 120 mg ASTX029.|Comparison of effect of food on AUC0-inf between Cohort 7 (fed state) and Cohort 10 (fasted state) treatment arm groups of 120 mg ASTX029 in C2D1.||113|14.3|
72469258|NCT03520075|144462143|SUPERIORITY||Geo LSM|17.5|||||TWO_SIDED|90.0|5.62|54.3|||||Ratio of Geo LSM was calculated for Cohort 6 (fed state) and Cohort 9 (fasted state) treatment arm groups of 80 mg ASTX029.|Comparison of effect of food on Cmax between Cohort 6 (fed state) and Cohort 9 (fasted state) treatment arm groups of 80 mg ASTX029 in C1D1.||54.3|5.62|
72565275|NCT01715896|144662034|SUPERIORITY_OR_OTHER||Percent difference|-3.5||||0.666|TWO_SIDED|90.0|-16.8|9.8|||Logit response Model||P-value and 90% unconditional exact confidence interval (CI) was calculated using the model of logit (response) = strata + treatment.|||9.8|-16.8|0.666
72565276|NCT01715896|144662035|SUPERIORITY_OR_OTHER||Percent difference|-8.6||||0.293|TWO_SIDED|90.0|-22.0|4.8|||Logit response Model||P-value and 90% unconditional exact CI was calculated using the model of logit (response) = strata + treatment.|||4.8|-22.0|0.293
72469259|NCT03520075|144462143|SUPERIORITY||Geo LSM|34.5|||||TWO_SIDED|90.0|12.0|99.4|||||Ratio of Geo LSM was calculated for Cohort 6 (fed state) and Cohort 9 (fasted state) treatment arm groups of 80 mg ASTX029.|Comparison of effect of food on Cmax between Cohort 6 (fed state) and Cohort 9 (fasted state) treatment arm groups of 80 mg ASTX029 in C2D1.||99.4|12.0|
72395036|NCT02700815|144296592|SUPERIORITY||Mean Difference (Net)|-0.5|STANDARD_ERROR_OF_MEAN|0.238||0.0347|TWO_SIDED|95.0|-0.97|-0.04|||ANCOVA|ANCOVA includes treatment, country, and application site (back/neck) as fixed effects, and baseline POMwp as a continuous covariate.|The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|An analysis of covariance (ANCOVA) was used to compare POMwp AUC(0-120 h) between placebo and combination therapy diclofenac + capsaicin||-0.04|-0.97|0.0347
72395037|NCT02700815|144296592|SUPERIORITY||Mean Difference (Net)|0.32|STANDARD_ERROR_OF_MEAN|0.169||0.0622|TWO_SIDED|95.0|-0.02|0.65|||ANCOVA|ANCOVA includes treatment, country, and application site (back/neck) as fixed effects, and baseline POMwp as a continuous covariate.|The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|An analysis of covariance (ANCOVA) was used to compare POMwp AUC(0-120 h) between capsaicin and combination therapy diclofenac + capsaicin||0.65|-0.02|0.0622
72395038|NCT02700815|144296592|SUPERIORITY||Mean Difference (Net)|-0.68|STANDARD_ERROR_OF_MEAN|0.169|<|0.0001|TWO_SIDED|95.0|-1.01|-0.35|||ANCOVA|ANCOVA includes treatment, country, and application site (back/neck) as fixed effects, and baseline POMwp as a continuous covariate.|The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|An analysis of covariance (ANCOVA) was used to compare POMwp AUC(0-120 h) between diclofenac and combination therapy diclofenac + capsaicin||-0.35|-1.01|<0.0001
72395039|NCT02700815|144296593|SUPERIORITY||Odds Ratio (OR)|1.882||||0.0202|TWO_SIDED|95.0|1.1|3.21|||Regression, Logistic|Logistic regression model include country and application site as covariates. Odds ratio was calculated as combination treatment/individual treatment.||A logistic regression was used to compare change in number of patients with a decrease in POMwp of at least 30% from baseline between placebo and combination therapy diclofenac + capsaicin. The likelihood-ratio test was used to test for differences between treatments.||3.21|1.10|0.0202
72395040|NCT02700815|144296593|SUPERIORITY||Odds Ratio (OR)|0.732||||0.1206|TWO_SIDED|95.0|0.49|1.09|||Regression, Logistic|Logistic regression model include country and application site as covariates. Odds ratio was calculated as combination treatment/individual treatment.||A logistic regression was used to compare change in number of patients with a decrease in POMwp of at least 30% from baseline between capsaicin and combination therapy diclofenac + capsaicin. The likelihood-ratio test was used to test for differences between treatments.||1.09|0.49|0.1206
72395041|NCT02700815|144296593|SUPERIORITY||Odds Ratio (OR)|1.629||||0.0122|TWO_SIDED|95.0|1.11|2.39|||Regression, Logistic|Logistic regression model include country and application site as covariates. Odds ratio was calculated as combination treatment/individual treatment.||A logistic regression was used to compare change in number of patients with a decrease in POMwp of at least 30% from baseline between diclofenac and combination therapy diclofenac + capsaicin. The likelihood-ratio test was used to test for differences between treatments.||2.39|1.11|0.0122
72395042|NCT02700815|144296594|SUPERIORITY||Odds Ratio (OR)|1.729||||0.0643|TWO_SIDED|95.0|0.97|3.09|||Regression, Logistic|Logistic regression model include country and application site as covariates. Odds ratio was calculated as combination treatment/individual treatment.||A logistic regression was used to compare change in number of patients with a decrease in POMwp of at least 50% from baseline between placebo and combination therapy diclofenac + capsaicin. The likelihood-ratio test was used to test for differences between treatments.||3.09|0.97|0.0643
72395043|NCT02700815|144296594|SUPERIORITY||Odds Ratio (OR)|0.833||||0.3479|TWO_SIDED|95.0|0.57|1.22|||Regression, Logistic|Logistic regression model include country and application site as covariates. Odds ratio was calculated as combination treatment/individual treatment.||A logistic regression was used to compare change in number of patients with a decrease in POMwp of at least 50% from baseline between capsaicin and combination therapy diclofenac + capsaicin. The likelihood-ratio test was used to test for differences between treatments.||1.22|0.57|0.3479
72395044|NCT02700815|144296594|SUPERIORITY||Odds Ratio (OR)|2.125||||0.0004|TWO_SIDED|95.0|1.4|3.22|||Regression, Logistic|Logistic regression model include country and application site as covariates. Odds ratio was calculated as combination treatment/individual treatment.||A logistic regression was used to compare change in number of patients with a decrease in POMwp of at least 50% from baseline between diclofenac and combination therapy diclofenac + capsaicin. The likelihood-ratio test was used to test for differences between treatments.||3.22|1.40|0.0004
72395045|NCT02700815|144296595|SUPERIORITY||Mean Difference (Net)|-1.05|STANDARD_ERROR_OF_MEAN|0.313||0.0008|TWO_SIDED|95.0|-1.67|-0.44|||Mixed Models Analysis||The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|A Mixed Model Repeat Measures (MMRM) analysis was used to compare change in POMwp from baseline between placebo and combination therapy diclofenac + capsaicin. MMRM model included fixed effects of treatment, country, application site (back/neck), time and fixed covariates of baseline POMwp and baseline POMwp by time interaction.||-0.44|-1.67|0.0008
72469260|NCT03520075|144462143|SUPERIORITY||Geo LSM|72.6|||||TWO_SIDED|90.0|17.6|299.0|||||Ratio of Geo LSM was calculated for Cohort 7 (fed state) and Cohort 10 (fasted state) treatment arm groups of 120 mg ASTX029.|Comparison of effect of food on Cmax between Cohort 7 (fed state) and Cohort 10 (fasted state) treatment arm groups of 120 mg ASTX029 in C1D1.||299|17.6|
72565277|NCT01715896|144662036|SUPERIORITY_OR_OTHER||Percent difference|-9.8||||0.156|TWO_SIDED|90.0|-21.1|1.4|||Logit Response Model||P-value and 90% unconditional exact CI was calculated using the model of logit (response) = strata + treatment.|||1.4|-21.1|0.156
72565278|NCT01715896|144662037|SUPERIORITY_OR_OTHER||Percent difference|-11.6||||0.108|TWO_SIDED|90.0|-23.2|0.0|||Logit Response Model||P-value and 90% unconditional exact CI was calculated using the model of logit (response) = strata + treatment.|||0.0|-23.2|0.108
72565279|NCT01715896|144662038|SUPERIORITY_OR_OTHER||Percent difference|-10.3||||0.208|TWO_SIDED|90.0|-23.7|3.0|||Logit Response Model||P-value and 90% unconditional exact CI was calculated using the model of logit (response) = strata + treatment.|||3.0|-23.7|0.2080
72565280|NCT01715896|144662045|SUPERIORITY_OR_OTHER||Adjusted Mean difference|-7.42||||0.213|TWO_SIDED|90.0|-17.24|2.4|||Repeated measures model||An estimate of the treatment difference and its 90% CI was computed by means of repeated measures model, adjusted for baseline and including a treatment by visit interaction term.|||2.40|-17.24|0.213
72565281|NCT01715896|144662047|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.61||||0.129|TWO_SIDED|90.0|0.36|1.04|||Proportional odds analysis||Odds ratio, 90% CI and p-value were was calculated using proportional odds analysis of response model including treatment as a factor.|||1.04|0.36|0.129
72565282|NCT01715896|144662048|SUPERIORITY_OR_OTHER||Percent difference|-11.6||||0.108||90.0|-23.2|0.0|||Regression, Logistic||90% CI was calculated for the treatment difference in proportion of responders using logisitic regression with strata and treatment as factors.|DAS28 (CRP) remission: p-value estimated from fisher's exact test when number of golimumab or active responders was less than 5.||0.0|-23.2|0.108
72565283|NCT01715896|144662048|SUPERIORITY_OR_OTHER||Percent difference|-11.7||||0.145|TWO_SIDED|90.0|-24.8|1.4|||Regression, Logistic||90% CI was calculated for the treatment difference in proportion of responders using logisitic regression with strata and treatment as factors.|The analysis reported DAS28 (CRP) low disease activity response.||1.4|-24.8|0.145
72622130|NCT04003142|144774325|SUPERIORITY||Odds Ratio (OR)|2.113||||0.001||95.0|1.349|3.332||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 7||3.332|1.349|0.001
72622131|NCT04003142|144774325|SUPERIORITY||Odds Ratio (OR)|2.594|||<|0.001||95.0|1.653|4.104||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 7||4.104|1.653|<0.001
72469261|NCT03520075|144462143|SUPERIORITY||Geo LSM|72.5|||||TWO_SIDED|90.0|29.1|181.0|||||Ratio of Geo LSM was calculated for Cohort 7 (fed state) and Cohort 10 (fasted state) treatment arm groups of 120 mg ASTX029.|Comparison of effect of food on Cmax between Cohort 7 (fed state) and Cohort 10 (fasted state) treatment arm groups of 120 mg ASTX029 in C1D1.||181|29.1|
72504380|NCT00995371|144539350|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.65|||>|0.05||95.0|-4.12|15.41|||t-test, 2 sided|||The mean change from baseline was assessed for ODI using a paired t-test. The resulting p-values are to be considered as descriptive statistics. Two-sided test with 5% Type I error was used.||15.41|-4.12|>0.05
72565284|NCT01715896|144662049|SUPERIORITY_OR_OTHER|||||||0.328|||||||Log Rank|P-value was calculated using the Log rank test.||||||0.328
72622132|NCT04003142|144774325|SUPERIORITY||Odds Ratio (OR)|1.891||||0.005|TWO_SIDED|95.0|1.21|2.973||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 8||2.973|1.210|0.005
72565285|NCT01715896|144662050|SUPERIORITY_OR_OTHER|||||||0.003|||||||Weibull model|P-value was calculated using an Weibull model.||||||0.003
72622133|NCT04003142|144774325|SUPERIORITY||Odds Ratio (OR)|3.314|||<|0.001||95.0|2.108|5.265||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 8||5.265|2.108|<0.001
72622134|NCT04003142|144774325|SUPERIORITY||Odds Ratio (OR)|1.646||||0.027||95.0|1.06|2.566||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 9||2.566|1.060|0.027
72469262|NCT03520075|144462144|SUPERIORITY||Hodges-Lehmann Estimator|-2.275||||0.0388671|TWO_SIDED|90.0|-5.216|-0.083|||Wilcoxon (Mann-Whitney)||The Hodges-Lehmann estimator and 90% confidence interval (CI) was calculated using the Moses approximation.|Comparison of effect of food on Tmax between Cohort 6 (fed state) and Cohort 9 (fasted state) treatment arm groups of 80 mg ASTX029 in C1D1.||-0.0830|-5.2160|0.0388671
72504381|NCT00995371|144539351|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.19|||<|0.05||95.0|0.61|3.77|||t-test, 2 sided|||The mean change from baseline was assessed for VAS using a paired t-test. The resulting p-values are to be considered as descriptive statistics. Two-sided test with 5% Type I error was used.||3.77|0.61|<0.05
72565286|NCT01715896|144662051|SUPERIORITY_OR_OTHER||Percent difference|-1.7||||0.795|TWO_SIDED|90.0|-12.4|9.0|||Regression, Logistic||90% CI was calculated for the treatment difference in proportion of responders using logisitic regression with strata and treatment as factors.|P-value estimated from fisher's exact test when number of golimumab or active responders was less than 5.||9.0|-12.4|0.795
72565287|NCT01715896|144662052|SUPERIORITY_OR_OTHER||Percent difference|-11.7||||0.048|TWO_SIDED|90.0|-21.0|-2.5|||Regression, Logistic||90% CI was calculated for the treatment difference in proportion of responders using logisitic regression with strata and treatment as factors.|||-2.5|-21.0|0.048
72565288|NCT01715896|144662053|SUPERIORITY_OR_OTHER||Percent difference|-11.9||||0.035|TWO_SIDED|90.0|-20.6|-3.1|||Regression, Logistic||90% CI was calculated for the treatment difference in proportion of responders using logisitic regression with strata and treatment as factors.|||-3.1|-20.6|0.035
72565289|NCT01715896|144662054|SUPERIORITY_OR_OTHER||Percent difference|-7.5||||0.061|TWO_SIDED|90.0|-13.6|-1.5|||Regression, Logistic||90% CI was calculated for the treatment difference in proportion of responders using logisitic regression with strata and treatment as factors.|||-1.5|-13.6|0.061
72565290|NCT01715896|144662055|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.01||||0.993|TWO_SIDED|90.0|-1.33|1.32|||Repeated measures model||An estimate of the treatment difference and its 90% CI was computed by means of repeated measures model, adjusted for baseline and including terms for treatment group, visit and treatment by visit interaction.|Analysis reported for change from baseline in swollen joint count at Day 169.||1.32|-1.33|0.993
72565291|NCT01715896|144662055|SUPERIORITY_OR_OTHER||Adjusted mean difference|1.23||||0.424|TWO_SIDED|90.0|-1.31|3.77|||Repeated measures model||An estimate of the treatment difference and its 90% CI was computed by means of repeated measures model, adjusted for baseline and including terms for treatment group, visit and treatment by visit interaction.|Analysis reported for change from baseline in Tender joint count at Day 169.||3.77|-1.31|0.424
72565292|NCT01715896|144662056|SUPERIORITY_OR_OTHER||Adjusted mean difference|4.89||||0.272|TWO_SIDED|90.0|-2.46|12.24|||Repeated measures model||An estimate of the treatment difference and its 90% CI was computed by means of repeated measures model, adjusted for baseline and including terms for treatment group, visit and treatment by visit interaction.|||12.24|-2.46|0.272
72565293|NCT01715896|144662057|SUPERIORITY_OR_OTHER||Adjusted mean difference|4.46||||0.319|TWO_SIDED|90.0|-2.92|11.84|||Repeated measures model||An estimate of the treatment difference and its 90% CI was computed by means of repeated measures model, adjusted for baseline and including terms for treatment group, visit and treatment by visit interaction.|||11.84|-2.92|0.319
72622135|NCT04003142|144774325|SUPERIORITY||Odds Ratio (OR)|2.347|||<|0.001||95.0|1.507|3.683||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 9||3.683|1.507|<0.001
72469263|NCT03520075|144462144|SUPERIORITY||Hodges-Lehmann Estimator|1.45||||0.4795001|TWO_SIDED|90.0|-0.917|5.15|||Wilcoxon (Mann-Whitney)||The Hodges-Lehmann estimator and 90% CI was calculated using the Moses approximation.|Comparison of effect of food on Tmax between Cohort 6 (fed state) and Cohort 9 (fasted state) treatment arm groups of 80 mg ASTX029 in C2D1.||5.1500|-0.9170|0.4795001
72469264|NCT03520075|144462144|SUPERIORITY||Hodges-Lehmann Estimator|-0.45||||0.8272593|TWO_SIDED|90.0|-2.467|0.95|||Wilcoxon (Mann-Whitney)||The Hodges-Lehmann estimator and 90% CI was calculated using the Moses approximation.|Comparison of effect of food on Tmax between Cohort 7 (fed state) and Cohort 10 (fasted state) treatment arm groups of 120 mg ASTX029 in C1D1.||0.9500|-2.4670|0.8272593
72469265|NCT03520075|144462144|SUPERIORITY||Hodges-Lehmann Estimator|0.583||||0.5126908|TWO_SIDED|90.0|-6.45|3.5|||Wilcoxon (Mann-Whitney)||The Hodges-Lehmann estimator and 90% CI was calculated using the Moses approximation.|Comparison of effect of food on Tmax between Cohort 7 (fed state) and Cohort 10 (fasted state) treatment arm groups of 120 mg ASTX029 in C2D1.||3.5000|-6.4500|0.5126908
72469266|NCT01234883|144462165|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
72469267|NCT01375751|144462202|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-43.82|STANDARD_ERROR_OF_MEAN|3.92|<|0.001|TWO_SIDED|95.0|-51.56|-36.09||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|ANCOVA|ANCOVA model includes treatment group and LDL-C level and baseline ezetimibe use as covariates.|Placebo is the reference.|The null hypothesis was that there was no mean difference in the percent change from baseline at Week 12 in LDL-C between evolocumab and placebo.||-36.09|-51.56|<0.001
72469268|NCT01375751|144462202|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-56.36|STANDARD_ERROR_OF_MEAN|3.9|<|0.001|TWO_SIDED|95.0|-64.06|-48.67||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|ANCOVA|ANCOVA model includes treatment group and LDL-C level and baseline ezetimibe use as covariates.|Placebo is the reference|The null hypothesis was that there was no mean difference in the percent change from baseline at Week 12 in LDL-C between evolocumab and placebo.||-48.67|-64.06|<0.001
72469269|NCT01375751|144462203|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-65.5|STANDARD_ERROR_OF_MEAN|7.1|<|0.001|TWO_SIDED|95.0|-79.6|-51.4||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|ANCOVA|ANCOVA model includes treatment group and LDL-C level and baseline ezetimibe use as covariates.|Placebo is the reference|||-51.4|-79.6|<0.001
72469270|NCT01375751|144462203|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-84.7|STANDARD_ERROR_OF_MEAN|7.1|<|0.001|TWO_SIDED|95.0|-98.8|-70.7||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|ANCOVA|ANCOVA model includes treatment group and LDL-C level and baseline ezetimibe use as covariates.|Placebo is the reference|||-70.7|-98.8|<0.001
72504382|NCT00995371|144539351|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.0|||>|0.05||95.0|-0.66|2.66|||t-test, 2 sided|||The mean change from baseline was assessed for VAS using a paired t-test. The resulting p-values are to be considered as descriptive statistics. Two-sided test with 5% Type I error was used.||2.66|-0.66|>0.05
72504383|NCT00995371|144539352|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.13|||<|0.05||95.0|7.43|24.83|||t-test, 2 sided|||The mean change from baseline was assessed for ODI using a paired t-test. The resulting p-values are to be considered as descriptive statistics. Two-sided test with 5% Type I error was used.||24.83|7.43|<0.05
72504384|NCT00995371|144539352|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.17|||>|0.05||95.0|-1.24|13.58|||t-test, 2 sided|||The mean change from baseline was assessed for ODI using a paired t-test. The resulting p-values are to be considered as descriptive statistics. Two-sided test with 5% Type I error was used.||13.58|-1.24|>0.05
72504385|NCT03414359|144539378|NON_INFERIORITY|As there is no existing data in the literature that clearly defines a clinically significant reduction in the onset time of anesthesia, the non-inferiority margin was defined a priori based on clinical reasoning.||||||0.1||||||The a priori threshold for statistical significance is, \<0.05|Wilcoxon (Mann-Whitney)|||To exclude a clinically important difference between the LEBF group and the chloroprocaine group, given a standard deviation of 4 minutes, and a non-inferiority margin of 3 minutes difference between groups, 62 mother-infant dyads (31 mother-infant dyads in each arm) are required to have a significance level of 5% and a power of 90%. In total, 70 female patients were recruited to account for any withdrawals.||||0.10
72622136|NCT04003142|144774325|SUPERIORITY||Odds Ratio (OR)|1.792||||0.01|TWO_SIDED|95.0|1.153|2.799||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 10||2.799|1.153|0.010
72469271|NCT01375751|144462204|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-41.79|STANDARD_ERROR_OF_MEAN|3.81|<|0.001|TWO_SIDED|95.0|-49.32|-34.26||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|ANCOVA|ANCOVA model includes treatment group and LDL-C level and baseline ezetimibe use as covariates.|Placebo is the reference|||-34.26|-49.32|<0.001
72469272|NCT01375751|144462204|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-53.46|STANDARD_ERROR_OF_MEAN|3.79|<|0.001|TWO_SIDED|95.0|-60.95|-45.97||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|ANCOVA|ANCOVA model includes treatment group and LDL-C level and baseline ezetimibe use as covariates.|Placebo is the reference|||-45.97|-60.95|<0.001
72469273|NCT01375751|144462205|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-34.75|STANDARD_ERROR_OF_MEAN|3.55|<|0.001|TWO_SIDED|95.0|-41.77|-27.74||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|ANCOVA|ANCOVA model includes treatment group and LDL-C level and baseline ezetimibe use as covariates.|Placebo is the reference|||-27.74|-41.77|<0.001
72469274|NCT01375751|144462205|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-46.2|STANDARD_ERROR_OF_MEAN|3.53|<|0.001|TWO_SIDED|95.0|-53.18|-39.23||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|ANCOVA|ANCOVA model includes treatment group and LDL-C level and baseline ezetimibe use as covariates.|Placebo is the reference|||-39.23|-53.18|<0.001
72469275|NCT01375751|144462206|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-36.66|STANDARD_ERROR_OF_MEAN|3.72|<|0.001|TWO_SIDED|95.0|-44.01|-29.32||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|ANCOVA|ANCOVA model includes treatment group and LDL-C level and baseline ezetimibe use as covariates.|Placbo is the reference|||-29.32|-44.01|<0.001
72504386|NCT02273973|144539380|SUPERIORITY||Difference in Response Rates|10.71||||0.049|TWO_SIDED|95.0|0.11|21.32|||Cochran-Mantel-Haenszel|||||21.32|0.11|0.0490
72504387|NCT02273973|144539381|SUPERIORITY||Difference in Response Rates|1.21||||0.3698|TWO_SIDED|95.0|-1.12|3.55|||Fisher Exact|||||3.55|-1.12|0.3698
72622137|NCT04003142|144774325|SUPERIORITY||Odds Ratio (OR)|2.819|||<|0.001||95.0|1.805|4.441||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 10||4.441|1.805|<0.001
72469276|NCT01375751|144462206|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-45.01|STANDARD_ERROR_OF_MEAN|3.7|<|0.001|TWO_SIDED|95.0|-52.32|-37.7||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|ANCOVA|ANCOVA model includes treatment group and LDL-C level and baseline ezetimibe use as covariates.|Placebo is the reference|||-37.70|-52.32|<0.001
72469277|NCT01375751|144462207|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-33.92|STANDARD_ERROR_OF_MEAN|3.45|<|0.001|TWO_SIDED|95.0|-40.72|-27.11||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|ANCOVA|ANCOVA model includes treatment group and LDL-C level and baseline ezetimibe use as covariates.|Placebo is the reference|||-27.11|-40.72|<0.001
72469278|NCT01375751|144462207|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-44.64|STANDARD_ERROR_OF_MEAN|3.43|<|0.001|TWO_SIDED|95.0|-51.41|-37.86||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|ANCOVA|ANCOVA model includes treatment group and LDL-C level and baseline ezetimibe use as covariates.|Placebo is the reference|||-37.86|-51.41|<0.001
72469279|NCT02980523|144462208|NON_INFERIORITY_OR_EQUIVALENCE|The aim of this study was to find the ideal dose of treatment for bacterial eradication and non-inferiority with the comparative groups.||||||0.002|||||||Chi-squared|||||||0.002
72469280|NCT02980523|144462209|NON_INFERIORITY|The aim of this study was to find the ideal dose of treatment for bacterial eradication and non-inferiority with the comparative groups.||||||0.372|||||||Chi-squared, Corrected|||||||0.372
72469281|NCT02980523|144462210|NON_INFERIORITY|The aim of this study was to find the ideal dose of treatment for bacterial eradication and non-inferiority with the comparative groups.||||||0.341|||||||Chi-squared, Corrected|||||||0.341
72469282|NCT02980523|144462211|NON_INFERIORITY|The aim of this study was to find the ideal dose of treatment for bacterial eradication and non-inferiority with the comparative groups.||||||0.001|||||||Chi-squared, Corrected|||||||0.001
72469283|NCT02980523|144462212|NON_INFERIORITY|The aim of this study was to find the ideal dose of treatment for bacterial eradication and non-inferiority with the comparative groups.||||||0.003|||||||Chi-squared, Corrected|||||||0.003
72469284|NCT02980523|144462213|NON_INFERIORITY|The aim of this study was to find the ideal dose of treatment for bacterial eradication and non-inferiority with the comparative groups.||||||0.216|||||||Chi-squared, Corrected|||||||0.216
72469285|NCT02980523|144462214|NON_INFERIORITY|The aim of this study was to find the ideal dose of treatment for bacterial eradication and non-inferiority with the comparative groups.||||||0.829|||||||Chi-squared, Corrected|||||||0.829
72469286|NCT01271504|144462238|SUPERIORITY||Hazard Ratio (HR)|0.92|||||TWO_SIDED|95.0|0.56|1.5||||||||1.50|0.56|
72469287|NCT01271504|144462239|SUPERIORITY||Hazard Ratio (HR)|0.92|||||TWO_SIDED|95.0|0.57|1.5||||||||1.50|0.57|
72469288|NCT01271504|144462241|SUPERIORITY||Hazard Ratio (HR)|0.99|||||TWO_SIDED|95.0|0.6|1.62||||||||1.62|0.60|
72469289|NCT02552147|144462244|SUPERIORITY|||||||0.44|||||||Wilcoxon (Mann-Whitney)|Two-tailed||||||.44
72469290|NCT02552147|144462245|SUPERIORITY|||||||0.38|||||||Wilcoxon (Mann-Whitney)|Two-tailed||||||0.38
72469291|NCT02552147|144462249|SUPERIORITY|||||||0.13|||||||Wilcoxon (Mann-Whitney)|Two-tailed||||||0.13
72469292|NCT02552147|144462250|SUPERIORITY|||||||0.13|||||||Wilcoxon (Mann-Whitney)|Two-tailed||||||0.13
72469293|NCT02552147|144462251|SUPERIORITY|||||||0.5|||||||Wilcoxon (Mann-Whitney)|Two-tailed||||||0.50
72469294|NCT02552147|144462252|SUPERIORITY|||||||1||||||P value was calculated to \>0.99 and thus rounded to 1.0.|Wilcoxon (Mann-Whitney)|Two-tailed||||||1.0
72469295|NCT02552147|144462253|SUPERIORITY|||||||0.25|||||||Wilcoxon (Mann-Whitney)|Two-tailed||||||0.25
72469296|NCT02552147|144462254|SUPERIORITY|||||||0.69|||||||Binomial test|||||||0.69
72469297|NCT02229227|144462262|NON_INFERIORITY|If the upper bound of the confidence interval is less than or equal to 0.3%, non-inferiority will be concluded.|Mean Difference (Net)|0.06|||<|0.0001|TWO_SIDED|95.0|-0.05|0.17||Non-inferiority p-value. P-value from testing the null hypothesis that the difference in change from baseline least squares means (albiglutide-insulin lispro) is greater than 0.30% based on one-sided t-test with 0.025 level of significance.|t-test, 2 sided||Least Square mean of albiglutide + insulin glargine from insulin lispro + insulin glargine has been presented.|||0.17|-0.05|<0.0001
72469298|NCT02229227|144462264|OTHER||Odds Ratio (OR)|0.43|||<|0.0001|TWO_SIDED|95.0|0.31|0.6||Analysis was performed using non-parametric Cochran-Mantel-Haenszel (CMH) test after adjusting for Baseline HbA1c category, age category, region and current use of metformin.|Cochran-Mantel-Haenszel||Odds ratio (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented.|||0.60|0.31|<0.0001
72469299|NCT02229227|144462265|SUPERIORITY||Mean Difference (Net)|-4.37|||<|0.0001|TWO_SIDED|95.0|-4.93|-3.82|||t-test, 2 sided||Least Square mean difference (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented.|||-3.82|-4.93|<0.0001
72469300|NCT02229227|144462266|OTHER||Mean Difference (Net)|-1.21|||||TWO_SIDED|95.0|-1.43|-1.0|||||Least Square mean difference (albiglutide + insulin glargine minus insulin lispro + insulin glargine) at Week 4 has been presented.|Week 4||-1.00|-1.43|
72469301|NCT02229227|144462266|OTHER||Mean Difference (Net)|-1.8|||||TWO_SIDED|95.0|-2.05|-1.55|||||Least Square mean difference (albiglutide + insulin glargine minus insulin lispro + insulin glargine) at Week 5 has been presented.|Week 5||-1.55|-2.05|
72469302|NCT02229227|144462266|OTHER||Mean Difference (Net)|-3.17|||||TWO_SIDED|95.0|-3.51|-2.82|||||Least Square mean difference (albiglutide + insulin glargine minus insulin lispro + insulin glargine) at Week 10 has been presented.|Week 10||-2.82|-3.51|
72469303|NCT02229227|144462266|OTHER||Mean Difference (Net)|-4.01|||||TWO_SIDED|95.0|-4.48|-3.54|||||Least Square mean difference (albiglutide + insulin glargine minus insulin lispro + insulin glargine) at Week 18 has been presented.|Week 18||-3.54|-4.48|
72504388|NCT02273973|144539382|SUPERIORITY||Difference in Response Rates|18.19||||0.0332|TWO_SIDED|95.0|2.57|33.81|||Cochran-Mantel-Haenszel|||||33.81|2.57|0.0332
72504389|NCT02273973|144539383|SUPERIORITY||Difference in Response Rates|1.37||||0.4803|TWO_SIDED|95.0|-1.3|4.04|||Fisher Exact|||||4.04|-1.30|0.4803
72504390|NCT02273973|144539384|SUPERIORITY||Difference in Response Rates|5.2||||0.5017|TWO_SIDED|95.0|-9.2|19.61|||Cochran-Mantel-Haenszel|||||19.61|-9.20|0.5017
72469304|NCT02229227|144462266|OTHER||Mean Difference (Net)|-4.37|||<|0.0001|TWO_SIDED|95.0|-4.93|-3.82|||t-test, 2 sided||Least Square mean difference (albiglutide + insulin glargine minus insulin lispro + insulin glargine) at Week 26 has been presented.|Week 26||-3.82|-4.93|<0.0001
72469305|NCT02229227|144462267|SUPERIORITY||Mean Difference (Final Values)|-60.83|||<|0.0001|TWO_SIDED|95.0|-66.57|-55.1|||t-test, 2 sided||Least square mean difference (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented.|||-55.10|-66.57|<0.0001
72469306|NCT02229227|144462268|NON_INFERIORITY|Difference in change from Baseline least squares means (albiglutide - insulin lispro) is greater than 0.30% based on one-sided t-test with 0.025 level of significance|Mean Difference (Net)|-0.12|||<|0.0001|TWO_SIDED|95.0|-0.18|-0.07|||t-test, 1 sided||Least square mean difference (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented for Week 4.|Week 4||-0.07|-0.18|<0.0001
72469307|NCT02229227|144462268|NON_INFERIORITY|Difference in change from Baseline least squares means (albiglutide - insulin lispro) is greater than 0.30% based on one-sided t-test with 0.025 level of significance|Mean Difference (Net)|-0.09|||<|0.0001|TWO_SIDED|95.0|-0.15|-0.02|||t-test, 1 sided||Least square mean difference (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented for Week 5.|Week 5||-0.02|-0.15|<0.0001
72504391|NCT02273973|144539385|SUPERIORITY||Difference in Response Rates|1.05||||1|TWO_SIDED|95.0|-2.65|4.75|||Fisher Exact|||||4.75|-2.65|1.0000
72504392|NCT02273973|144539386|SUPERIORITY||Difference in Response Rates|21.14||||0.0115|TWO_SIDED|95.0|5.59|36.68|||Cochran-Mantel-Haenszel|||||36.68|5.59|0.0115
72504393|NCT02273973|144539387|SUPERIORITY||Difference in Response Rates|2.66||||0.7928|TWO_SIDED|95.0|-11.88|17.2|||Cochran-Mantel-Haenszel|||||17.20|-11.88|0.7928
72504394|NCT02273973|144539388|SUPERIORITY||Difference in Response Rates|9.45||||0.2659|TWO_SIDED|95.0|-5.8|24.7|||Cochran-Mantel-Haenszel|||||24.70|-5.80|0.2659
72504395|NCT02273973|144539389|SUPERIORITY||Difference in Response Rates|7.63||||0.3299|TWO_SIDED|95.0|-6.34|21.6|||Cochran-Mantel-Haenszel|||||21.60|-6.34|0.3299
72504396|NCT02273973|144539390|SUPERIORITY||Difference in Response Rates|10.68||||0.1554|TWO_SIDED|95.0|-3.96|25.32|||Cochran-Mantel-Haenszel|||||25.32|-3.96|0.1554
72504397|NCT02273973|144539391|SUPERIORITY||Difference in Response Rates|2.41||||0.787|TWO_SIDED|95.0|-11.82|16.63|||Cochran-Mantel-Haenszel|||||16.63|-11.82|0.7870
72504398|NCT02273973|144539392|SUPERIORITY||Ratio of Least square mean|0.83||||0.117|TWO_SIDED|95.0|0.65|1.05|||Regression, Linear|||Statistical analysis for changes in Ki67 levels from Baseline to Week 3.||1.05|0.65|0.117
72504399|NCT02273973|144539392|SUPERIORITY||Ratio of Least square mean|1.25||||0.105|TWO_SIDED|95.0|0.95|1.65|||Regression, Linear|||Statistical analysis for changes in Ki67 levels from Baseline to Surgery.||1.65|0.95|0.105
72504400|NCT02273973|144539394|SUPERIORITY||Least squares mean difference|-13.32||||0.002|TWO_SIDED|95.0|-21.67|-4.96|||Regression, Linear|||||-4.96|-21.67|0.002
72469308|NCT02229227|144462268|NON_INFERIORITY|Difference in change from Baseline least squares means (albiglutide - insulin lispro) is greater than 0.30% based on one-sided t-test with 0.025 level of significance|Mean Difference (Net)|0.08|||<|0.0001|TWO_SIDED|95.0|-0.01|0.17|||t-test, 1 sided||Least square mean difference (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented for Week 10.|Week 10||0.17|-0.01|<0.0001
72469309|NCT02229227|144462268|NON_INFERIORITY|Difference in change from Baseline least squares means (albiglutide - insulin lispro) is greater than 0.30% based on one-sided t-test with 0.025 level of significance|Mean Difference (Net)|0.11|||<|0.0001|TWO_SIDED|95.0|0.01|0.21|||t-test, 1 sided||Least square mean difference (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented for Week 18.|Week 18||0.21|0.01|<0.0001
72504401|NCT01282814|144539414|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|115.85|||||TWO_SIDED|90.0|108.45|123.72|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||123.72|108.45|
72504402|NCT01282814|144539415|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|109.97|||||TWO_SIDED|90.0|103.68|116.63|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||116.63|103.68|
72504403|NCT01282814|144539416|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|106.46|||||TWO_SIDED|90.0|101.45|111.71|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||111.71|101.45|
72504404|NCT02209597|144539428|SUPERIORITY||||||<|0.05|ONE_SIDED|90.0|||||ANOVA|||||||<0.05
72565294|NCT01715896|144662058|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.16||||0.64|TWO_SIDED|90.0|-0.42|0.74|||Repeated measures model||An estimate of the treatment difference and its 90% CI was computed by means of repeated measures model, adjusted for baseline and including terms for treatment group, visit and treatment by visit interaction.|||0.74|-0.42|0.640
72565295|NCT01715896|144662059|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.18||||0.055|TWO_SIDED|90.0|0.03|0.34|||Repeated measures model||An estimate of the treatment difference and its 90% CI was computed by means of repeated measures model, adjusted for baseline and including terms for treatment group, visit and treatment by visit interaction.|||0.34|0.03|0.055
72469310|NCT02229227|144462268|NON_INFERIORITY|Difference in change from Baseline least squares means (albiglutide - insulin lispro) is greater than 0.30% based on one-sided t-test with 0.025 level of significance|Mean Difference (Net)|0.06|||<|0.0001|TWO_SIDED|95.0|-0.05|0.17|||t-test, 1 sided||Least square mean difference (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented for Week 26.|Week 26||0.17|-0.05|<0.0001
72469311|NCT02229227|144462269|SUPERIORITY||Mean Difference (Net)|-0.55||||0.0004|TWO_SIDED|95.0|-0.86|-0.25|||t-test, 2 sided||Least square mean difference (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented.|||-0.25|-0.86|0.0004
72469312|NCT02229227|144462270|OTHER||Mean Difference (Net)|-0.54|||||TWO_SIDED|95.0|-0.84|-0.24|||||Least square mean difference (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented for Week 4.|Week 4||-0.24|-0.84|
72469313|NCT02229227|144462270|OTHER||Mean Difference (Net)|-0.19|||||TWO_SIDED|95.0|-0.51|0.13|||||Least square mean difference (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented for Week 5.|Week 5||0.13|-0.51|
72469314|NCT02229227|144462270|OTHER||Mean Difference (Net)|-0.53|||||TWO_SIDED|95.0|-0.85|-0.22|||||Least square mean difference (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented for Week 18.|Week 18||-0.22|-0.85|
72469315|NCT02229227|144462270|SUPERIORITY||Mean Difference (Net)|-0.55||||0.0004|TWO_SIDED|95.0|-0.86|-0.25|||t-test, 2 sided||Least square mean difference (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented for Week 26.|Week 26||-0.25|-0.86|0.0004
72469316|NCT02229227|144462271|OTHER||Odds Ratio (OR)|0.96||||0.7026|TWO_SIDED|95.0|0.71|1.31||Non-parametric Cochran-Mantel-Haenszel (CMH) test after adjusting for Baseline HbA1c category, age category, region and current use of metformin.|Cochran-Mantel-Haenszel||Odds ratio (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented.|||1.31|0.71|0.7026
72469317|NCT02229227|144462272|OTHER||Odds Ratio (OR)|1.17||||0.2883|TWO_SIDED|95.0|0.84|1.64||Analysis was performed using non-parametric Cochran-Mantel-Haenszel (CMH) test after adjusting for baseline HbA1c category, age category, region and current use of metformin|Cochran-Mantel-Haenszel||Odds ratio (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented for Week 4|Week 4||1.64|0.84|0.2883
72469318|NCT02229227|144462272|OTHER||Odds Ratio (OR)|0.82||||0.3034|TWO_SIDED|95.0|0.59|1.15||Analysis was performed using non-parametric Cochran-Mantel-Haenszel (CMH) test after adjusting for baseline HbA1c category, age category, region and current use of metformin.|Cochran-Mantel-Haenszel||Odds ratio (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented for Week 5.|Week 5||1.15|0.59|0.3034
72469319|NCT02229227|144462272|OTHER||Odds Ratio (OR)|0.71||||0.0151|TWO_SIDED|95.0|0.52|0.98||Analysis was performed using non-parametric Cochran-Mantel-Haenszel (CMH) test after adjusting for baseline HbA1c category, age category, region and current use of metformin.|Cochran-Mantel-Haenszel||Odds ratio (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented for Week 10.|Week 10||0.98|0.52|0.0151
72504965|NCT00196937|144541121|NON_INFERIORITY|Non-inferiority with respect to seroconversion was shown if, for both anti-HPV-16 and anti-HPV-18 antibodies, the upper limit of the 95% confidence interval (CI) for the difference \[Cervarix (15-25 years) Group minus Cervarix (26-45 years) Group\] was below 10%.|Difference in SCR|0.0|||||TWO_SIDED|95.0|-1.87|2.03||||||Immune response to anti-HPV-18 in terms of SCR: To evaluate if the immunogenicity (as determined by ELISA) of the Cervarix vaccine, one month after the third dose (Month 7), in young women 26 - 45 years of age is non-inferior to that in women 15 - 25 years of age.||2.03|-1.87|
72469320|NCT02229227|144462272|OTHER||Odds Ratio (OR)|0.75||||0.0518|TWO_SIDED|95.0|0.54|1.03||Analysis was performed using non-parametric Cochran-Mantel-Haenszel (CMH) test after adjusting for baseline HbA1c category, age category, region and current use of metformin|Cochran-Mantel-Haenszel||Odds ratio (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented for Week 18.|Week 18||1.03|0.54|0.0518
72469321|NCT02229227|144462272|OTHER||Odds Ratio (OR)|0.96||||0.7026|TWO_SIDED|95.0|0.71|1.31||Analysis was performed using non-parametric Cochran-Mantel-Haenszel (CMH) test after adjusting for baseline HbA1c category, age category, region and current use of metformin|Cochran-Mantel-Haenszel||Odds ratio (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented for Week 26.|Week 26||1.31|0.71|0.7026
72469322|NCT02229227|144462273|OTHER||Odds Ratio (OR)|0.85||||0.2298|TWO_SIDED|95.0|0.63|1.17||Analysis was performed using non-parametric Cochran-Mantel-Haenszel (CMH) test after adjusting for baseline HbA1c category, age category, region and current use of metformin.|Cochran-Mantel-Haenszel||Odds ratio (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented.|||1.17|0.63|0.2298
72469323|NCT02229227|144462274|OTHER||Odds Ratio (OR)|1.32||||0.2143|TWO_SIDED|95.0|0.78|2.23||Analysis was performed using non-parametric Cochran-Mantel-Haenszel (CMH) test after adjusting for baseline HbA1c category, age category, region and current use of metformin.|Cochran-Mantel-Haenszel||Odds ratio (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented for Week 4.|Week 4||2.23|0.78|0.2143
72622138|NCT04003142|144774325|SUPERIORITY||Odds Ratio (OR)|2.357|||<|0.001||95.0|1.513|3.699||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 11||3.699|1.513|<0.001
72622139|NCT04003142|144774325|SUPERIORITY||Odds Ratio (OR)|3.131|||<|0.001||95.0|1.999|4.95||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 11||4.950|1.999|<0.001
72622140|NCT04003142|144774325|SUPERIORITY||Odds Ratio (OR)|1.373||||0.152||95.0|0.891|2.122||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 12||2.122|0.891|0.152
72622141|NCT04003142|144774325|SUPERIORITY||Odds Ratio (OR)|2.09|||<|0.001||95.0|1.351|3.252||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 12||3.252|1.351|<0.001
72622142|NCT04003142|144774326|SUPERIORITY||Odds Ratio (OR)|0.915||||0.951||95.0|0.036|23.464||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 1||23.464|0.036|0.951
72469324|NCT02229227|144462274|OTHER||Odds Ratio (OR)|1.24||||0.4703|TWO_SIDED|95.0|0.8|1.91||Analysis was performed using non-parametric Cochran-Mantel-Haenszel (CMH) test after adjusting for baseline HbA1c category, age category, region and current use of metformin.|Cochran-Mantel-Haenszel||Odds ratio (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented for Week 5.|Week 5||1.91|0.80|0.4703
72469325|NCT02229227|144462274|OTHER||Odds Ratio (OR)|0.81||||0.2139|TWO_SIDED|95.0|0.58|1.14||Analysis was performed using non-parametric Cochran-Mantel-Haenszel (CMH) test after adjusting for baseline HbA1c category, age category, region and current use of metformin.|Cochran-Mantel-Haenszel||Odds ratio (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented for Week 10.|Week 10||1.14|0.58|0.2139
72469326|NCT02229227|144462274|OTHER||Odds Ratio (OR)|0.81||||0.079|TWO_SIDED|95.0|0.59|1.11||Analysis was performed using non-parametric Cochran-Mantel-Haenszel (CMH) test after adjusting for baseline HbA1c category, age category, region and current use of metformin.|Cochran-Mantel-Haenszel||Odds ratio (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented for Week 18.|Week 18||1.11|0.59|0.0790
72469327|NCT02229227|144462274|OTHER||Odds Ratio (OR)|0.85||||0.2298|TWO_SIDED|95.0|0.63|1.17||Analysis was performed using non-parametric Cochran-Mantel-Haenszel (CMH) test after adjusting for baseline HbA1c category, age category, region and current use of metformin.|Cochran-Mantel-Haenszel||Odds ratio (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented for Week 26.|Week 26||1.17|0.63|0.2298
72469328|NCT02229227|144462275|OTHER||Odds Ratio (OR)|1.08||||0.8292|TWO_SIDED|95.0|0.24|4.77||Analysis was performed using non-parametric Cochran-Mantel-Haenszel (CMH) test after adjusting for baseline HbA1c category, age category, region and current use of metformin.|Cochran-Mantel-Haenszel||Odds ratio (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented.|||4.77|0.24|0.8292
72469329|NCT02229227|144462277|OTHER||Mean Difference (Final Values)|-56.38|||||TWO_SIDED|95.0|-59.19|-53.57|||||Least square mean difference (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented for Week 4.|Week 4||-53.57|-59.19|
72469330|NCT02229227|144462277|OTHER||Mean Difference (Final Values)|-63.7|||||TWO_SIDED|95.0|-67.78|-59.62|||||Least square mean difference (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented for Week 10.|Week 10||-59.62|-67.78|
72469331|NCT02229227|144462277|OTHER||Mean Difference (Final Values)|-62.0|||||TWO_SIDED|95.0|-67.29|-56.7|||||Least square mean difference (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented for Week 18.|Week 18||-56.70|-67.29|
72504405|NCT01855789|144539431|NON_INFERIORITY|Non-inferiority of TCZ + PBO was claimed if the upper bound of the 95% confidence interval (CI) for the mean difference was below 0.6.|Estimated Mean Difference|0.318|STANDARD_ERROR_OF_MEAN|0.139|||TWO_SIDED|95.0|0.045|0.592||||||Analysis of covariance (ANCOVA) model included Week 24 DAS28 as a covariate, treatment group, and the randomization stratification factors: DAS28 remission status at Week 24 (\<2.6, \>/=2.6 to \</=3.2), baseline weight-by-dosing group (\<80 kg q2w, \<80 kg qw, 80-\<100 kg q2w, 80-\<100 kg qw, \>/=100 kg qw), participant anti-tumor necrosis factor (anti-TNF) exposure (Yes/No).||0.592|0.045|
72504406|NCT01855789|144539432|SUPERIORITY||ACR 20 Response Rate Difference|-10.2||||0.0746|TWO_SIDED|95.0|-20.2|-0.2|||Cochran-Mantel-Haenszel||Observed difference in percentages (TCZ + PBO minus TCZ + MTX) and the asymptotic Wald 95% CI is presented.|Week 40: Analysis of association between treatment group and response, stratified by the randomization stratification factors: DAS28 remission status at Week 24 (\<2.6, \>=2.6 to \<=3.2), baseline weight-by-dosing group (\<80 kg q2w, \<80 kg qw, 80-\<100 kg q2w, 80-\<100 kg qw, \>=100 kg qw), participant anti-TNF exposure (Yes/No).||-0.2|-20.2|0.0746
72504407|NCT01855789|144539432|SUPERIORITY||ACR 20 Response Rate Difference|-8.8||||0.1159|TWO_SIDED|95.0|-19.3|1.6|||Cochran-Mantel-Haenszel||Observed difference in percentages (TCZ + PBO minus TCZ + MTX) and the asymptotic Wald 95% CI is presented.|Week 52: Analysis of association between treatment group and response, stratified by the randomization stratification factors: DAS28 remission status at Week 24 (\<2.6, \>=2.6 to \<=3.2), baseline weight-by-dosing group (\<80 kg q2w, \<80 kg qw, 80-\<100 kg q2w, 80-\<100 kg qw, \>=100 kg qw), participant anti-TNF exposure (Yes/No).||1.6|-19.3|0.1159
72504408|NCT01855789|144539432|SUPERIORITY||ACR 20 Response Rate Difference|-8.2|||||TWO_SIDED|95.0|-15.8|-0.6|||||Observed difference in percentages (TCZ + PBO minus TCZ + MTX) and the asymptotic Wald 95% CI is presented.|Week 24||-0.6|-15.8|
72504409|NCT01855789|144539433|SUPERIORITY||ACR 50 Response Rate Difference|-13.6||||0.0377|TWO_SIDED|95.0|-24.8|-2.4|||Cochran-Mantel-Haenszel||Observed difference in percentages (TCZ + PBO minus TCZ + MTX) and the asymptotic Wald 95% CI is presented.|Week 40: Analysis of association between treatment group and response, stratified by the randomization stratification factors: DAS28 remission status at Week 24 (\<2.6, \>=2.6 to \<=3.2), baseline weight-by-dosing group (\<80 kg q2w, \<80 kg qw, 80-\<100 kg q2w, 80-\<100 kg qw, \>=100 kg qw), participant anti-TNF exposure (Yes/No).||-2.4|-24.8|0.0377
72504966|NCT01462292|144541155|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-8.946||||0.554|TWO_SIDED|95.0|-39.122|21.229||Due to the two comparisons for the two different doses, the type 1 error rate (5% overall) was preserved by utilizing a hierarchical approach, testing the 6mg/kg GSK2402968 dose first|Mixed Model Repeated Measures|Model included terms for treatment, visit, treatment by visit, centre grouping, baseline and baseline by visit||Treatment difference: Placebo Vs GSK2402968 3 mg||21.229|-39.122|0.554
72469332|NCT02229227|144462278|SUPERIORITY||Mean Difference (Final Values)|-0.97|||||TWO_SIDED|95.0|-2.25|0.3|||||Least square mean difference (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented for Week 4.|Week 4||0.30|-2.25|
72469333|NCT02229227|144462278|OTHER||Mean Difference (Final Values)|0.34|||||TWO_SIDED|95.0|-1.64|2.33|||||Least square mean difference (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented for Week 10.|Week 10||2.33|-1.64|
72469334|NCT02229227|144462278|OTHER||Mean Difference (Final Values)|0.24|||||TWO_SIDED|95.0|-2.21|2.69|||||Least square mean difference (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented for Week 18.|Week 18||2.69|-2.21|
72469335|NCT02229227|144462278|OTHER||Mean Difference (Final Values)|0.39||||0.7699|TWO_SIDED|95.0|-2.25|3.04|||t-test, 2 sided||Least square mean difference (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented for Week 26.|Week 26||3.04|-2.25|0.7699
72469336|NCT02229227|144462279|OTHER||Mean Difference (Final Values)|-56.05|||||TWO_SIDED|95.0|-58.17|-53.94|||||Least square mean difference (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented for Week 4.|Week 4||-53.94|-58.17|
72469337|NCT02229227|144462279|OTHER||Mean Difference (Final Values)|-64.76|||||TWO_SIDED|95.0|-67.68|-61.85|||||Least square mean difference (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented for Week 10.|Week 10||-61.85|-67.68|
72469338|NCT02229227|144462279|OTHER||Mean Difference (Final Values)|-62.92|||||TWO_SIDED|95.0|-66.69|-59.15|||||Least square mean difference (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented for Week 18.|Week 18||-59.15|-66.69|
72469339|NCT02229227|144462279|SUPERIORITY||Mean Difference (Final Values)|-61.83|||<|0.0001|TWO_SIDED|95.0|-65.85|-57.81|||t-test, 2 sided||Least square mean difference (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented for Week 26.|week 26||-57.81|-65.85|<0.0001
72469340|NCT02229227|144462281|OTHER||Odds Ratio (OR)|3.5|||<|0.0001|TWO_SIDED|95.0|2.52|4.86||Analysis was performed using non-parametric Cochran-Mantel-Haenszel (CMH) test after adjusting for baseline HbA1c category, age category, region and current use of metformin.|Cochran-Mantel-Haenszel||Odds ratio (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented.|||4.86|2.52|<0.0001
72469341|NCT02229227|144462282|OTHER||Odds Ratio (OR)|2.36|||<|0.0001|TWO_SIDED|95.0|1.54|3.6||Analysis was performed using non-parametric Cochran-Mantel-Haenszel (CMH) test after adjusting for baseline HbA1c category, age category, region and current use of metformin.|Cochran-Mantel-Haenszel||Odds ratio (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented.|||3.60|1.54|<0.0001
72469342|NCT02229227|144462283|OTHER||Odds Ratio (OR)|3.78|||<|0.0001|TWO_SIDED|95.0|2.21|6.48||Analysis was performed using non-parametric Cochran-Mantel-Haenszel (CMH) test after adjusting for baseline HbA1c category, age category, region and current use of metformin.|Cochran-Mantel-Haenszel||Odds ratio (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented.|||6.48|2.21|<0.0001
72469343|NCT05186311|144462303|EQUIVALENCE|The estimated regression equation was then used to estimate the bias (with two one-sided 95% confidence intervals, referred to as 95% limits in the text) between the evaluation tube and the comparator tube at all prespecified medical decision levels. The biases and 95% limit were compared to the clinical acceptance limit (CAL).||||||||||||||||One hundred (100) participants (with paired numerical data) per each analyte provide \> 90% power to ensure that mean biases and confidence intervals are within the clinical acceptance limit (CAL), at medically relevant points, assuming no true bias between the tube types, residual standard deviation (SD) or coefficient of variation (CV) = CAL and collected data cover medically relevant points.|"No p-value were established. Rather a bias between tube types at pre-determined medical decision points were estimated with 95% intervals. The mean biases and 95% limit were compared to the CAL. For equivalence testing the initial alpha level is set at 10%. This corresponds to obtaining 90% confidence intervals (associated with 95% two 1-sided confidence limits). Since the clinical equivalence includes two comparisons, the actual alpha used for each comparison was set to 5%, using a Bonferroni correction. No other adjustment for multiplicity will be made on any other comparisons.~Note that for the confidence intervals (CI) calculated for the intercept and slope of the regression parameters, no multiplicity adjustments on the a level are performed (alpha = 0.05)."|||
72469344|NCT05186311|144462304|EQUIVALENCE|The estimated regression equation was then used to estimate the bias (with two one-sided 95% confidence intervals, referred to as 95% limits in the text) between the evaluation tube and the comparator tube at all prespecified medical decision levels. The biases and 95% limit were compared to the clinical acceptance limit|||||||||||||||||"No p-value were established. Rather a bias between tube types at pre-determined medical decision points were estimated with 95% intervals. The mean biases and 95% limit were compared to the CAL. For equivalence testing the initial alpha level is set at 10%. This corresponds to obtaining 90% confidence intervals (associated with 95% two 1-sided confidence limits). Since the clinical equivalence includes two comparisons, the actual alpha used for each comparison was set to 5%, using a Bonferroni correction. No other adjustment for multiplicity will be made on any other comparisons.~Note that for the confidence intervals (CI) calculated for the intercept and slope of the regression parameters, no multiplicity adjustments on the a level are performed (alpha = 0.05)."|||
72504410|NCT01855789|144539433|SUPERIORITY||ACR 50 Response Rate Difference|-15.0||||0.013|TWO_SIDED|95.0|-26.2|-3.7|||Cochran-Mantel-Haenszel||Observed difference in percentages (TCZ + PBO minus TCZ + MTX) and the asymptotic Wald 95% CI is presented.|Week 52: Analysis of association between treatment group and response, stratified by the randomization stratification factors: DAS28 remission status at Week 24 (\<2.6, \>=2.6 to \<=3.2), baseline weight-by-dosing group (\<80 kg q2w, \<80 kg qw, 80-\<100 kg q2w, 80-\<100 kg qw, \>=100 kg qw), participant anti-TNF exposure (Yes/No).||-3.7|-26.2|0.0130
72504411|NCT01855789|144539433|SUPERIORITY||ACR 50 Response Rate Difference|-10.9|||||TWO_SIDED|95.0|-21.4|-0.4|||||Observed difference in percentages (TCZ + PBO minus TCZ + MTX) and the asymptotic Wald 95% CI is presented.|Week 24||-0.4|-21.4|
72504412|NCT01855789|144539434|SUPERIORITY||ACR 70 Response Rate Difference|-8.2||||0.3599|TWO_SIDED|95.0|-19.2|2.9|||Cochran-Mantel-Haenszel||Observed difference in percentages (TCZ + PBO minus TCZ + MTX) and the asymptotic Wald 95% CI is presented.|Week 40: Analysis of association between treatment group and response, stratified by the randomization stratification factors: DAS28 remission status at Week 24 (\<2.6, \>=2.6 to \<=3.2), baseline weight-by-dosing group (\<80 kg q2w, \<80 kg qw, 80-\<100 kg q2w, 80-\<100 kg qw, \>=100 kg qw), participant anti-TNF exposure (Yes/No).||2.9|-19.2|0.3599
72504413|NCT01855789|144539434|SUPERIORITY||ACR 70 Response Rate Difference|-11.6||||0.0663|TWO_SIDED|95.0|-22.8|-0.3|||Cochran-Mantel-Haenszel||Observed difference in percentages (TCZ + PBO minus TCZ + MTX) and the asymptotic Wald 95% CI is presented.|Week 52: Analysis of association between treatment group and response, stratified by the randomization stratification factors: DAS28 remission status at Week 24 (\<2.6, \>=2.6 to \<=3.2), baseline weight-by-dosing group (\<80 kg q2w, \<80 kg qw, 80-\<100 kg q2w, 80-\<100 kg qw, \>=100 kg qw), participant anti-TNF exposure (Yes/No).||-0.3|-22.8|0.0663
72469345|NCT05186311|144462305|EQUIVALENCE|The estimated regression equation was then used to estimate the bias (with two one-sided 95% confidence intervals, referred to as 95% limits in the text) between the evaluation tube and the comparator tube at all prespecified medical decision levels. The biases and 95% limit were compared to the clinical acceptance limit|||||||||||||||||"No p-value were established. Rather a bias between tube types at pre-determined medical decision points were estimated with 95% intervals. The mean biases and 95% limit were compared to the CAL. For equivalence testing the initial alpha level is set at 10%. This corresponds to obtaining 90% confidence intervals (associated with 95% two 1-sided confidence limits). Since the clinical equivalence includes two comparisons, the actual alpha used for each comparison was set to 5%, using a Bonferroni correction. No other adjustment for multiplicity will be made on any other comparisons.~Note that for the confidence intervals (CI) calculated for the intercept and slope of the regression parameters, no multiplicity adjustments on the a level are performed (alpha = 0.05)."|||
72469346|NCT05186311|144462306|EQUIVALENCE|The estimated regression equation was then used to estimate the bias (with two one-sided 95% confidence intervals, referred to as 95% limits in the text) between the evaluation tube and the comparator tube at all prespecified medical decision levels. The biases and 95% limit were compared to the clinical acceptance limit|||||||||||||||||"No p-value were established. Rather a bias between tube types at pre-determined medical decision points were estimated with 95% intervals. The mean biases and 95% limit were compared to the CAL. For equivalence testing the initial alpha level is set at 10%. This corresponds to obtaining 90% confidence intervals (associated with 95% two 1-sided confidence limits). Since the clinical equivalence includes two comparisons, the actual alpha used for each comparison was set to 5%, using a Bonferroni correction. No other adjustment for multiplicity will be made on any other comparisons.~Note that for the confidence intervals (CI) calculated for the intercept and slope of the regression parameters, no multiplicity adjustments on the a level are performed (alpha = 0.05)."|||
72469347|NCT05186311|144462307|EQUIVALENCE|The estimated regression equation was then used to estimate the bias (with two one-sided 95% confidence intervals, referred to as 95% limits in the text) between the evaluation tube and the comparator tube at all prespecified medical decision levels. The biases and 95% limit were compared to the clinical acceptance limit|||||||||||||||||"No p-value were established. Rather a bias between tube types at pre-determined medical decision points were estimated with 95% intervals. The mean biases and 95% limit were compared to the CAL. For equivalence testing the initial alpha level is set at 10%. This corresponds to obtaining 90% confidence intervals (associated with 95% two 1-sided confidence limits). Since the clinical equivalence includes two comparisons, the actual alpha used for each comparison was set to 5%, using a Bonferroni correction. No other adjustment for multiplicity will be made on any other comparisons.~Note that for the confidence intervals (CI) calculated for the intercept and slope of the regression parameters, no multiplicity adjustments on the a level are performed (alpha = 0.05)."|||
72469348|NCT05186311|144462308|EQUIVALENCE|The estimated regression equation was then used to estimate the bias (with two one-sided 95% confidence intervals, referred to as 95% limits in the text) between the evaluation tube and the comparator tube at all prespecified medical decision levels. The biases and 95% limit were compared to the clinical acceptance limit|||||||||||||||||"No p-value were established. Rather a bias between tube types at pre-determined medical decision points were estimated with 95% intervals. The mean biases and 95% limit were compared to the CAL. For equivalence testing the initial alpha level is set at 10%. This corresponds to obtaining 90% confidence intervals (associated with 95% two 1-sided confidence limits). Since the clinical equivalence includes two comparisons, the actual alpha used for each comparison was set to 5%, using a Bonferroni correction. No other adjustment for multiplicity will be made on any other comparisons.~Note that for the confidence intervals (CI) calculated for the intercept and slope of the regression parameters, no multiplicity adjustments on the a level are performed (alpha = 0.05)."|||
72469349|NCT05186311|144462309|EQUIVALENCE|The estimated regression equation was then used to estimate the bias (with two one-sided 95% confidence intervals, referred to as 95% limits in the text) between the evaluation tube and the comparator tube at all prespecified medical decision levels. The biases and 95% limit were compared to the clinical acceptance limit|||||||||||||||||"No p-value were established. Rather a bias between tube types at pre-determined medical decision points were estimated with 95% intervals. The mean biases and 95% limit were compared to the CAL. For equivalence testing the initial alpha level is set at 10%. This corresponds to obtaining 90% confidence intervals (associated with 95% two 1-sided confidence limits). Since the clinical equivalence includes two comparisons, the actual alpha used for each comparison was set to 5%, using a Bonferroni correction. No other adjustment for multiplicity will be made on any other comparisons.~Note that for the confidence intervals (CI) calculated for the intercept and slope of the regression parameters, no multiplicity adjustments on the a level are performed (alpha = 0.05)."|||
72469350|NCT05186311|144462310|EQUIVALENCE|The estimated regression equation was then used to estimate the bias (with two one-sided 95% confidence intervals, referred to as 95% limits in the text) between the evaluation tube and the comparator tube at all prespecified medical decision levels. The biases and 95% limit were compared to the clinical acceptance limit|||||||||||||||||"No p-value were established. Rather a bias between tube types at pre-determined medical decision points were estimated with 95% intervals. The mean biases and 95% limit were compared to the CAL. For equivalence testing the initial alpha level is set at 10%. This corresponds to obtaining 90% confidence intervals (associated with 95% two 1-sided confidence limits). Since the clinical equivalence includes two comparisons, the actual alpha used for each comparison was set to 5%, using a Bonferroni correction. No other adjustment for multiplicity will be made on any other comparisons.~Note that for the confidence intervals (CI) calculated for the intercept and slope of the regression parameters, no multiplicity adjustments on the a level are performed (alpha = 0.05)."|||
72504414|NCT01855789|144539434|SUPERIORITY||ACR 70 Response Rate Difference|-8.2|||||TWO_SIDED|95.0|-19.4|3.1|||||Observed difference in percentages (TCZ + PBO minus TCZ + MTX) and the asymptotic Wald 95% CI is presented.|Week 24||3.1|-19.4|
72469351|NCT05186311|144462311|EQUIVALENCE|The estimated regression equation was then used to estimate the bias (with two one-sided 95% confidence intervals, referred to as 95% limits in the text) between the evaluation tube and the comparator tube at all prespecified medical decision levels. The biases and 95% limit were compared to the clinical acceptance limit|||||||||||||||||"No p-value were established. Rather a bias between tube types at pre-determined medical decision points were estimated with 95% intervals. The mean biases and 95% limit were compared to the CAL. For equivalence testing the initial alpha level is set at 10%. This corresponds to obtaining 90% confidence intervals (associated with 95% two 1-sided confidence limits). Since the clinical equivalence includes two comparisons, the actual alpha used for each comparison was set to 5%, using a Bonferroni correction. No other adjustment for multiplicity will be made on any other comparisons.~Note that for the confidence intervals (CI) calculated for the intercept and slope of the regression parameters, no multiplicity adjustments on the a level are performed (alpha = 0.05)."|||
72622143|NCT04003142|144774326|SUPERIORITY||Odds Ratio (OR)|2.889||||0.362|TWO_SIDED|95.0|0.364|58.864||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 1||58.864|0.364|0.362
72469352|NCT05186311|144462312|EQUIVALENCE|The estimated regression equation was then used to estimate the bias (with two one-sided 95% confidence intervals, referred to as 95% limits in the text) between the evaluation tube and the comparator tube at all prespecified medical decision levels. The biases and 95% limit were compared to the clinical acceptance limit|||||||||||||||||"No p-value were established. Rather a bias between tube types at pre-determined medical decision points were estimated with 95% intervals. The mean biases and 95% limit were compared to the CAL. For equivalence testing the initial alpha level is set at 10%. This corresponds to obtaining 90% confidence intervals (associated with 95% two 1-sided confidence limits). Since the clinical equivalence includes two comparisons, the actual alpha used for each comparison was set to 5%, using a Bonferroni correction. No other adjustment for multiplicity will be made on any other comparisons.~Note that for the confidence intervals (CI) calculated for the intercept and slope of the regression parameters, no multiplicity adjustments on the a level are performed (alpha = 0.05)."|||
72469353|NCT05186311|144462313|EQUIVALENCE|The estimated regression equation was then used to estimate the bias (with two one-sided 95% confidence intervals, referred to as 95% limits in the text) between the evaluation tube and the comparator tube at all prespecified medical decision levels. The biases and 95% limit were compared to the clinical acceptance limit|||||||||||||||||"No p-value were established. Rather a bias between tube types at pre-determined medical decision points were estimated with 95% intervals. The mean biases and 95% limit were compared to the CAL. For equivalence testing the initial alpha level is set at 10%. This corresponds to obtaining 90% confidence intervals (associated with 95% two 1-sided confidence limits). Since the clinical equivalence includes two comparisons, the actual alpha used for each comparison was set to 5%, using a Bonferroni correction. No other adjustment for multiplicity will be made on any other comparisons.~Note that for the confidence intervals (CI) calculated for the intercept and slope of the regression parameters, no multiplicity adjustments on the a level are performed (alpha = 0.05)."|||
72469354|NCT05186311|144462314|EQUIVALENCE|The estimated regression equation was then used to estimate the bias (with two one-sided 95% confidence intervals, referred to as 95% limits in the text) between the evaluation tube and the comparator tube at all prespecified medical decision levels. The biases and 95% limit were compared to the clinical acceptance limit|||||||||||||||||"No p-value were established. Rather a bias between tube types at pre-determined medical decision points were estimated with 95% intervals. The mean biases and 95% limit were compared to the CAL. For equivalence testing the initial alpha level is set at 10%. This corresponds to obtaining 90% confidence intervals (associated with 95% two 1-sided confidence limits). Since the clinical equivalence includes two comparisons, the actual alpha used for each comparison was set to 5%, using a Bonferroni correction. No other adjustment for multiplicity will be made on any other comparisons.~Note that for the confidence intervals (CI) calculated for the intercept and slope of the regression parameters, no multiplicity adjustments on the a level are performed (alpha = 0.05)."|||
72469355|NCT03178344|144462345|EQUIVALENCE|ANOVA||||||0.7||||||P value threshold is 0.05|ANOVA|||||||0.70
72469356|NCT03178344|144462346|EQUIVALENCE|ANOVA||||||0.71||||||P value threshold is 0.05.|ANOVA|||||||0.71
72469357|NCT04560374|144462370|EQUIVALENCE|Power analysis was performed after the completion of the study. 98% power was obtained.|||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
72469358|NCT02489734|144462395|SUPERIORITY||Relative risk (RR)|3.4||||0.003|TWO_SIDED|95.0|1.4|8.1|||Chi-squared|||||8.1|1.4|0.003
72469359|NCT03721172|144462396|SUPERIORITY||Adjusted difference|17.5|||<|0.0001|TWO_SIDED|95.0|12.2|22.8|||Cochran-Mantel-Haenszel|Stratification were based on baseline sPGA (2 \[mild\] vs 3 \[moderate\]).|2-sided 95% CIs based on the stratified Newcombe method. Stratification were based on baseline sPGA (2 \[mild\] vs 3 \[moderate\]).|||22.8|12.2|<0.0001
72469360|NCT03721172|144462397|SUPERIORITY||Adjusted difference|25.6|||<|0.0001|TWO_SIDED|95.0|19.1|32.1|||Cochran-Mantel-Haenszel|Stratification were based on baseline sPGA (2 \[mild\] vs 3 \[moderate\]).|2-sided 95% CIs based on the stratified Newcombe method. Stratification were based on baseline sPGA (2 \[mild\] vs 3 \[moderate\]).|||32.1|19.1|<0.0001
72469361|NCT03721172|144462398|SUPERIORITY||Least squares mean difference|-3.38|STANDARD_ERROR_OF_MEAN|0.33|<|0.0001|TWO_SIDED|95.0|-4.04|-2.73|||Mixed-effect model for repeated measures|||||-2.73|-4.04|<0.0001
72469362|NCT03721172|144462399|SUPERIORITY||Least squares mean difference|-2.93|STANDARD_ERROR_OF_MEAN|0.27|<|0.0001|TWO_SIDED|95.0|-3.47|-2.39|||Mixed-effect model for repeated measures|||||-2.39|-3.47|<0.0001
72622144|NCT04003142|144774326|SUPERIORITY||Odds Ratio (OR)|2.775||||0.138||95.0|0.785|12.87||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 2||12.870|0.785|0.138
72622145|NCT04003142|144774326|SUPERIORITY||Odds Ratio (OR)|1.342||||0.704||95.0|0.291|6.914||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 2||6.914|0.291|0.704
72470174|NCT01667549|144464587|OTHER|Repeated Measures ANOVA were done with type of cereal as within-subjects and experimental group as grouping factors. When significant, planned comparisons were carried out. ANOVAs with a priori contrasts specified determined whether 1-month exposure differed from the no-exposure control (timing hypothesis). ANOVAs with a priori contrasts specified determined whether 1-month differed from 3-months exposure and whether these groups differed from no-exposure control (duration hypothesis).||||||0.02||||||Bonferroni adjustment was made and only planned pairwise comparisons with calculated p values of 0.02 or lower significant.|planned comparison|Bonferroni adjustment was calculated and only planned pair-wise comparisons with calculated p value 0.02 or lower were considered significant.||Separate analyses of variance with a priori contrasts specified were conducted: 1) to determine whether the 1-month exposure groups (1M0.5, 1M1.5, and 1M2.5) differed from the no-exposure control group to test the hypothesis that the timing of exposure affected acceptance; and 2) to determine whether 1 month of exposure differed from 3 months (1M0.5, 3M0.5 groups) and whether these groups differed from the no-exposure control group (duration hypothesis).||||0.02
72470175|NCT01667549|144464588|OTHER||||||<|0.02|||||||ANOVA|||Repeated measures ANOVAs were conducted on maternal gLMS ratings with type of juice and time as the within-subject factors and experimental group as the grouping factor||||<0.02
72470176|NCT01667549|144464589|OTHER|Repeated Measures ANOVA were done with type of cereal as within-subjects and experimental group as grouping factors. When significant, planned comparisons were carried out. ANOVAs with a priori contrasts specified determined whether 1-month exposure differed from the no-exposure control (timing hypothesis). ANOVAs with a priori contrasts specified determined whether 1-month differed from 3-months exposure and whether these groups differed from no-exposure control (duration hypothesis).|||||<|0.02||||||Because three comparisons were made for each outcome measure, a Bonferroni adjustment was calculated and only planned comparison with P's\<0.02 were considered significant.|planned comparison|a Bonferroni adjustment was calculated and only planned comparison with P's\<0.02 were considered significant.||Separate analyses of variance with a priori contrasts specified were conducted: 1) to determine whether the 1-month exposure groups (1M0.5, 1M1.5, and 1M2.5) differed from the no-exposure control group to test the hypothesis that the timing of exposure affected acceptance; and 2) to determine whether 1 month of exposure differed from 3 months (1M0.5, 3M0.5 groups) and whether these groups differed from the no-exposure control group (duration hypothesis).||||<0.02
72470177|NCT01667549|144464590|OTHER||||||<|0.02||||||Because three comparisons were made for each outcome measure, a Bonferroni adjustment was calculated and only planned comparison with P\<0.02 were considered significant.|planned comparison|A Bonferroni adjustment was calculated and only planned comparison with P's\<0.02 were considered significant.||Separate analyses of variance with a priori contrasts specified 1) to determine whether the 1-month exposure groups (1M0.5, 1M1.5, and 1M2.5) differed from the no-exposure control group to test the hypothesis that the timing of exposure affected acceptance; and 2) to determine whether 1 month of exposure differed from 3 months (1M0.5, 3M0.5 groups) and whether these groups differed from the no-exposure control group (duration hypothesis).||||<0.02
72470178|NCT01667549|144464591|OTHER||||||<|0.05|||||||ANOVA|||General linear models were conducted on WLZ scores with time as the within-subjects factor and Group as the between-subjects factor to determine there were differences in growth of the infants over time. This was not done to test hypothesis but to monitor growth of infants during course of trial.||||<0.05
72470179|NCT02844777|144464592|OTHER|||||||0.9518|||||||ANCOVA|||||||0.9518
72470180|NCT02844777|144464592|OTHER|||||||0.2458|||||||ANCOVA|||||||0.2458
72470181|NCT02844777|144464593|OTHER|||||||0.6201|||||||Fisher Exact|||||||0.6201
72470182|NCT02844777|144464593|OTHER|||||||1|||||||Fisher Exact|||||||1.0000
72470183|NCT02844777|144464594|OTHER|||||||0.2912|||||||ANCOVA|||||||0.2912
72470184|NCT02844777|144464594|OTHER|||||||0.4168|||||||ANCOVA|||||||0.4168
72470185|NCT02844777|144464595|OTHER|||||||0.6458|||||||ANCOVA|||||||0.6458
72470186|NCT02844777|144464595|OTHER|||||||0.0721|||||||ANCOVA|||||||0.0721
72470187|NCT02844777|144464596|OTHER|||||||0.42|||||||ANCOVA|||||||0.4200
72470188|NCT02844777|144464596|OTHER|||||||0.0241|||||||ANCOVA|||||||0.0241
72470189|NCT00150618|144464597|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0041||95.0|||||ANCOVA|||||||0.0041
72470190|NCT00150618|144464597|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0176||95.0|||||ANCOVA|||||||0.0176
72470191|NCT00150618|144464597|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0016||95.0|||||ANCOVA|||||||0.0016
72470192|NCT00150618|144464597|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0006||95.0|||||ANCOVA|||||||0.0006
72470193|NCT00150618|144464598|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001||95.0|||||ANCOVA|||||||0.0010
72470194|NCT00150618|144464598|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0468||95.0|||||ANCOVA|||||||0.0468
72470195|NCT00150618|144464598|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0056||95.0|||||ANCOVA|||||||0.0056
72470196|NCT00150618|144464598|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0237||95.0|||||ANCOVA|||||||0.0237
72470197|NCT00150618|144464599|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0074||95.0|||||Cochran-Mantel-Haenszel|||||||0.0074
72470198|NCT00150618|144464599|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1404||95.0|||||Cochran-Mantel-Haenszel|||||||0.1404
72470199|NCT00150618|144464599|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0055||95.0|||||Cochran-Mantel-Haenszel|||||||0.0055
72470200|NCT00150618|144464599|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0041||95.0|||||Cochran-Mantel-Haenszel|||||||0.0041
72470201|NCT00150618|144464600|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0303||95.0|||||Cochran-Mantel-Haenszel|||||||0.0303
72470202|NCT00150618|144464600|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4982||95.0|||||Cochran-Mantel-Haenszel|||||||0.4982
72470203|NCT00150618|144464600|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0017||95.0|||||Cochran-Mantel-Haenszel|||||||0.0017
72470204|NCT00150618|144464600|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0063||95.0|||||Cochran-Mantel-Haenszel|||||||0.0063
72470205|NCT00150618|144464601|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0383||95.0|||||ANCOVA|||Psychosocial category||||0.0383
72470206|NCT00150618|144464601|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5859||95.0|||||ANCOVA|||Psychosocial category||||0.5859
72470207|NCT00150618|144464601|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2136||95.0|||||ANCOVA|||Psychosocial category||||0.2136
72470208|NCT00150618|144464601|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1483||95.0|||||ANCOVA|||Psychosocial category||||0.1483
72470209|NCT02493946|144464602|SUPERIORITY||Treatment difference|80.8|||<|0.0001|TWO_SIDED|95.0|73.7|88.0||The treatment difference and p-value were obtained from a logistic regression on responders with treatment group, gender, baseline severity score on ILA at maximum frown and centre as fixed variables.|Regression, Logistic|||Treatment difference against placebo in the adjusted percentage of responders.||88.0|73.7|<0.0001
72470210|NCT02493946|144464603|SUPERIORITY||Treatment difference|75.0|||<|0.0001|TWO_SIDED|95.0|67.1|82.8||The treatment difference and p-value were obtained from a logistic regression on responders with treatment group, gender, baseline severity score on ILA at maximum frown and centre as fixed variables.|Regression, Logistic|||Treatment difference against placebo in the adjusted percentage of responders at Day 8 Cycle 1.||82.8|67.1|<0.0001
72470211|NCT02493946|144464603|SUPERIORITY||Treatment difference|74.1|||<|0.0001|TWO_SIDED|95.0|66.2|82.1||The treatment difference and p-value were obtained from a logistic regression on responders with treatment group, gender, baseline severity score on ILA at maximum frown and centre as fixed variables.|Regression, Logistic|||Treatment difference against placebo in the adjusted percentage of responders at Day 57 Cycle 1.||82.1|66.2|<0.0001
72470212|NCT02493946|144464603|SUPERIORITY||Treatment difference|53.6|||<|0.0001|TWO_SIDED|95.0|44.2|63.1||The treatment difference and p-value were obtained from a logistic regression on responders with treatment group, gender, baseline severity score on ILA at maximum frown and centre as fixed variables.|Regression, Logistic|||Treatment difference against placebo in the adjusted percentage of responders at Day 85 Cycle 1.||63.1|44.2|<0.0001
72470213|NCT02493946|144464605|SUPERIORITY||Treatment difference|58.0|||<|0.0001|TWO_SIDED|95.0|44.5|71.6||The treatment difference and p-value were obtained from a logistic regression on responders with treatment group, gender, baseline severity score on ILA at maximum frown and centre as fixed variables.|Regression, Logistic|||Treatment difference against placebo in the adjusted percentage of responders at Day 8 Cycle 1.||71.6|44.5|<0.0001
72470214|NCT02493946|144464605|SUPERIORITY||Treatment difference|56.8|||<|0.0001|TWO_SIDED|95.0|44.5|69.0||The treatment difference and p-value were obtained from a logistic regression on responders with treatment group, gender, baseline severity score on ILA at maximum frown and centre as fixed variables.|Regression, Logistic|||Treatment difference against placebo in the adjusted percentage of responders at Day 29 Cycle 1.||69.0|44.5|<0.0001
72470215|NCT02493946|144464605|SUPERIORITY||Treatment difference|62.5|||<|0.0001|TWO_SIDED|95.0|52.1|72.9||The treatment difference and p-value were obtained from a logistic regression on responders with treatment group, gender, baseline severity score on ILA at maximum frown and centre as fixed variables.|Regression, Logistic|||Treatment difference against placebo in the adjusted percentage of responders at Day 57 Cycle 1.||72.9|52.1|<0.0001
72470216|NCT02493946|144464605|SUPERIORITY||Treatment difference|42.6|||<|0.0001|TWO_SIDED|95.0|29.5|55.7||The treatment difference and p-value were obtained from a logistic regression on responders with treatment group, gender, baseline severity score on ILA at maximum frown and centre as fixed variables.|Regression, Logistic|||Treatment difference against placebo in the adjusted percentage of responders at Day 85 Cycle 1.||55.7|29.5|<0.0001
72470217|NCT02493946|144464606|SUPERIORITY||Treatment difference|61.1|||<|0.0001|TWO_SIDED|95.0|51.9|70.3||The treatment difference and p-value were obtained from a logistic regression on responders with treatment group, gender, baseline severity score on ILA at maximum frown and centre as fixed variables.|Regression, Logistic|||Treatment difference against placebo in the adjusted percentage of responders at Day 8 Cycle 1.||70.3|51.9|<0.0001
72505044|NCT01380093|144541431|SUPERIORITY_OR_OTHER||LS Mean Difference|-15.7|||<|0.0001|TWO_SIDED|95.0|-20.2|-11.1||p-value adjusted for multiple comparisons with Hochberg adjustment. At least one primary outcome for each of drug liking and high was required to be significant with adjusted p-value less than or equal to 0.05.|Mixed Models Analysis|||LS mean and 95% CI were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence. Planned power of at least 89% assumed a mean difference of 15 to 30 points and a standard deviation of paired differences of 15 to 20 points, with conservative multiple comparison adjustment for alpha of 0.025.||-11.1|-20.2|<0.0001
72505045|NCT01380093|144541431|SUPERIORITY_OR_OTHER||LS Mean Difference|13.4|||<|0.0001|TWO_SIDED|95.0|8.9|18.0||p-value adjusted for multiple comparisons with Hochberg adjustment.|Mixed Models Analysis|||LS mean and 95% CI were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||18.0|8.9|<0.0001
72470218|NCT02493946|144464606|SUPERIORITY||Treatment difference|65.8|||<|0.0001|TWO_SIDED|95.0|56.8|74.8||The treatment difference and p-value were obtained from a logistic regression on responders with treatment group, gender, baseline severity score on ILA at maximum frown and centre as fixed variables.|Regression, Logistic|||Treatment difference against placebo in the adjusted percentage of responders at Day 29 Cycle 1.||74.8|56.8|<0.0001
72576654|NCT01564537|144680102|SUPERIORITY||Odds Ratio (OR)|1.3|||=|0.332|TWO_SIDED|95.0|0.69|2.45||P-value is from Cochran-Mantel-Haenszel stratified by: prior therapies (1, 2 or 3), proteasome inhibitor (exposed, naïve), and ISS Stage at Screening (I or II, III).|Cochran-Mantel-Haenszel||Odds ratio is from logistic regression model with prognostic factors: prior therapies (1, 2 or 3), proteasome inhibitor (exposed, naïve),and ISS Stage at Screening (I or II, III). Odds ratio \> 1 favors Ixazomib.|||2.45|0.69|=0.332
72576655|NCT01635218|144680103|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.0|STANDARD_ERROR_OF_MEAN|0.8|<|0.05|TWO_SIDED|95.0|3.1|7.0||The ANOVA result (p\<0.05)suggests rejecting the global null hypothesis.Bonferroni post-hoc test was used to determine which means differ among groups.|ANOVA|||||7.0|3.1|<0.05
72470219|NCT02493946|144464606|SUPERIORITY||Treatment difference|70.5|||<|0.0001|TWO_SIDED|95.0|62.2|78.8||The treatment difference and p-value were obtained from a logistic regression on responders with treatment group, gender, baseline severity score on ILA at maximum frown and centre as fixed variables.|Regression, Logistic|||Treatment difference against placebo in the adjusted percentage of responders at Day 57 Cycle 1.||78.8|62.2|<0.0001
72470220|NCT02493946|144464606|SUPERIORITY||Treatment difference|33.0|||<|0.0001|TWO_SIDED|95.0|24.0|42.0||The treatment difference and p-value were obtained from a logistic regression on responders with treatment group, gender, baseline severity score on ILA at maximum frown and centre as fixed variables.|Regression, Logistic|||Treatment difference against placebo in the adjusted percentage of responders at Day 85 Cycle 1.||42.0|24.0|<0.0001
72470221|NCT02493946|144464607|SUPERIORITY||Treatment difference|68.2|||<|0.0001|TWO_SIDED|95.0|58.2|78.3||The treatment difference and p-value were obtained from a logistic regression on responders with treatment group, gender, baseline severity score on ILA at maximum frown and centre as fixed variables.|Regression, Linear|||Treatment difference against placebo in the adjusted percentage of responders at Day 8 Cycle 1.||78.3|58.2|<0.0001
72470222|NCT02493946|144464607|SUPERIORITY||Treatment difference|77.4|||<|0.0001|TWO_SIDED|95.0|68.6|86.2||The treatment difference and p-value were obtained from a logistic regression on responders with treatment group, gender, baseline severity score on ILA at maximum frown and centre as fixed variables.|Regression, Logistic|||Treatment difference against placebo in the adjusted percentage of responders at Day 29 Cycle 1.||86.2|68.6|<0.0001
72470223|NCT02493946|144464607|SUPERIORITY||Treatment difference|74.4|||<|0.0001|TWO_SIDED|95.0|65.7|83.1||The treatment difference and p-value were obtained from a logistic regression on responders with treatment group, gender, baseline severity score on ILA at maximum frown and centre as fixed variables.|Regression, Logistic|||Treatment difference against placebo in the adjusted percentage of responders at Day 57 Cycle 1.||83.1|65.7|<0.0001
72470224|NCT02493946|144464607|SUPERIORITY||Treatment difference|51.0|||<|0.0001|TWO_SIDED|95.0|42.0|59.9||The treatment difference and p-value were obtained from a logistic regression on responders with treatment group, gender, baseline severity score on ILA at maximum frown and centre as fixed variables.|Regression, Logistic|||Treatment difference against placebo in the adjusted percentage of responders at Day 85 Cycle 1.||59.9|42.0|<0.0001
72470225|NCT02493946|144464608|SUPERIORITY||Hazard Ratio (HR)|15.296|||<|0.0001|TWO_SIDED||||||Cox proportional hazard model|The cox proportional hazard model used centre, gender and ILA baseline severity score as covariates.||Treatment difference in median time to onset of treatment response.||||<0.0001
72470226|NCT02493946|144464609|SUPERIORITY||Treatment difference|8.6|||<|0.0001|TWO_SIDED|95.0|5.2|12.0||The general linear model included mean change from baseline as a dependent variable and treatment group, gender and centre as fixed effects, and baseline severity score on ILA at maximum frown as covariates.|General linear model|||Treatment difference ( BTX-A-HAC Solution - Placebo) at Day 8 Cycle 1.||12.0|5.2|<0.0001
72470227|NCT02493946|144464609|SUPERIORITY||Treatment difference|11.1|||<|0.0001|TWO_SIDED|95.0|7.4|14.8||The general linear model included mean change from baseline as a dependent variable and treatment group, gender and centre as fixed effects, and baseline severity score on ILA at maximum frown as covariates.|General linear model|||Treatment difference (BTX-A-HAC Solution - Placebo) at Day 29 Cycle 1.||14.8|7.4|<0.0001
72470228|NCT02493946|144464609|SUPERIORITY||Treatment difference|10.4|||<|0.0001|TWO_SIDED|95.0|6.8|14.0||The general linear model included mean change from baseline as a dependent variable and treatment group, gender and centre as fixed effects, and baseline severity score on ILA at maximum frown as covariates.|General linear model|||Treatment difference (BTX-A-HAC Solution - Placebo) at Day 57 Cycle 1.||14.0|6.8|<0.0001
72470229|NCT02493946|144464609|SUPERIORITY||Treatment difference|9.6|||<|0.0001|TWO_SIDED|95.0|5.9|13.3||The general linear model included mean change from baseline as a dependent variable and treatment group, gender and centre as fixed effects, and baseline severity score on ILA at maximum frown as covariates.|General linear model|||Treatment difference (BTX-A-HAC Solution - Placebo) at Day 85 Cycle 1.||13.3|5.9|<0.0001
72470230|NCT02493946|144464610|SUPERIORITY||Treatment difference|9.3|||<|0.0001|TWO_SIDED|95.0|5.0|13.6||The general linear model included mean change from baseline as a dependent variable and treatment group, gender and centre as fixed effects, and baseline severity score on ILA at maximum frown as covariate.|General linear model|||Treatment difference (BTX-A-HAC Solution - Placebo) at Day 8 Cycle 1.||13.6|5.0|<0.0001
72470231|NCT02493946|144464610|SUPERIORITY||Treatment difference|11.4|||<|0.0001|TWO_SIDED|95.0|6.7|16.0||The general linear model included mean change from baseline as a dependent variable and treatment group, gender and centre as fixed effects, and baseline severity score on ILA at maximum frown as covariate.|General linear model|||Treatment difference (BTX-A-HAC Solution - Placebo) at Day 29 Cycle 1.||16.0|6.7|<0.0001
72470232|NCT02493946|144464610|SUPERIORITY||Treatment difference|11.2|||<|0.0001|TWO_SIDED|95.0|6.4|15.9||The general linear model included mean change from baseline as a dependent variable and treatment group, gender and centre as fixed effects, and baseline severity score on ILA at maximum frown as covariate.|General linear model|||Treatment difference (BTX-A-HAC Solution - Placebo) at Day 57 Cycle 1.||15.9|6.4|<0.0001
72470233|NCT02493946|144464610|SUPERIORITY||Treatment difference|8.1||||0.0004|TWO_SIDED|95.0|3.7|12.6||The general linear model included mean change from baseline as a dependent variable and treatment group, gender and centre as fixed effects, and baseline severity score on ILA at maximum frown as covariate.|General linear model|||Treatment difference (BTX-A-HAC Solution - Placebo) at Day 85 Cycle 1.||12.6|3.7|0.0004
72470234|NCT02493946|144464611|SUPERIORITY||Treatment difference|-0.6||||0.0174|TWO_SIDED|95.0|-1.1|-0.1||The general linear model included mean change from baseline as a dependent variable and treatment group, gender and centre as fixed effects, and baseline severity score on ILA at maximum frown as covariate.|General linear model|||Treatment difference (BTX-A-HAC Solution - Placebo) at Day 8 Cycle 1.||-0.1|-1.1|0.0174
72470235|NCT02493946|144464611|SUPERIORITY||Treatment difference|-1.2|||<|0.0001|TWO_SIDED|95.0|-1.7|-0.6||The general linear model included mean change from baseline as a dependent variable and treatment group, gender and centre as fixed effects, and baseline severity score on ILA at maximum frown as covariate.|General linear model|||Treatment difference (BTX-A-HAC Solution - Placebo) at Day 29 Cycle 1.||-0.6|-1.7|<0.0001
72470236|NCT02493946|144464611|SUPERIORITY||Treatment difference|-1.4||||0.0001|TWO_SIDED|95.0|-2.0|-0.7||The general linear model included mean change from baseline as a dependent variable and treatment group, gender and centre as fixed effects, and baseline severity score on ILA at maximum frown as covariate.|General linear model|||Treatment difference (BTX-A-HAC Solution - Placebo) at Day 57 Cycle 1.||-0.7|-2.0|0.0001
72470237|NCT02493946|144464611|SUPERIORITY||Treatment difference|-1.4|||<|0.0001|TWO_SIDED|95.0|-2.1|-0.8||The general linear model included mean change from baseline as a dependent variable and treatment group, gender and centre as fixed effects, and baseline severity score on ILA at maximum frown as covariate.|General linear model|||Treatment difference (BTX-A-HAC Solution - Placebo) at Day 85 Cycle 1.||-0.8|-2.1|<0.0001
72470238|NCT01727505|144464628|SUPERIORITY_OR_OTHER|||||||0.44|||||||Wilcoxon signed rank test|||||||0.44
72470239|NCT01727505|144464629|SUPERIORITY_OR_OTHER|||||||0.75|||||||Wilcoxon signed rank test|||||||.75
72470240|NCT01727505|144464630|SUPERIORITY_OR_OTHER|||||||0.2|||||||Wilcoxon signed rank test|||||||0.2
72470241|NCT01727505|144464631|SUPERIORITY_OR_OTHER|||||||0.02|||||||Wilcoxon signed rank test|||||||0.02
72470242|NCT01727505|144464632|SUPERIORITY_OR_OTHER|||||||0.049|||||||Wilcoxon signed rank test|||||||.049
72470243|NCT01727505|144464633|SUPERIORITY_OR_OTHER|||||||0.006|||||||Paired t-test|||||||0.006
72470244|NCT01814072|144464658|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<.001
72470245|NCT01814072|144464659|SUPERIORITY||Estimated Change|0.1244||||0.567|TWO_SIDED|95.0|-0.3026|0.5513|||Mixed Models Analysis|||||.5513|-.3026|0.567
72470246|NCT01814072|144464659|SUPERIORITY||Estimated Change|-0.0226||||0.917|TWO_SIDED|95.0|-0.4495|0.4044|||Mixed Models Analysis|||||.4044|-.4495|0.917
72470247|NCT01814072|144464659|SUPERIORITY||Estimated Change|0.084||||0.699|TWO_SIDED|95.0|-0.3429|0.5109|||Mixed Models Analysis|||||.5109|-.3429|0.699
72470248|NCT01814072|144464659|SUPERIORITY||Estimated Change|0.1081||||0.619|TWO_SIDED|95.0|-0.3188|0.535|||Mixed Models Analysis|||||.5350|-.3188|0.619
72470249|NCT01814072|144464659|SUPERIORITY||Estimated Change|-0.4353||||0.046|TWO_SIDED|95.0|-0.8622|-0.0084|||Mixed Models Analysis|||||-.0084|-.8622|0.046
72470250|NCT01814072|144464660|OTHER||Estimated Change|0.424||||0.051|TWO_SIDED|95.0|-0.002|0.85|||Mixed Models Analysis|||Using the results from primary aim 1, an intervention with only active treatment components with the largest treatment effect that can be obtained for implementation costs of $500 or less was identified and built.||0.850|-0.002|0.051
72470251|NCT01011868|144464667|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.56|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001|TWO_SIDED|97.5|-0.78|-0.33||Hypotheses were tested at significance level of 0.025, which is half of overall alpha of 0.05, split equally between 2 treatment comparisons. This maintained the overall type-I (alpha) at 5%. There was no a priori assumption on testing order.|ANCOVA|ANCOVA that included treatment group and geographic region as fixed effects along with baseline HbA1c as covariate.|The primary analysis consisted of the pair-wise comparisons between each dose of empagliflozin versus placebo using the adjusted means from the model.|"The null and alternative hypotheses to be tested:~* H0,1: No difference in change from baseline to Week 18 in HbA1c between empagliflozin 10 mg and placebo~* H1,1: A difference in change from baseline to Week 18 in HbA1c between empagliflozin 10 mg and placebo"||-0.33|-0.78|<0.0001
72470252|NCT01011868|144464667|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.7|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001|TWO_SIDED|97.5|-0.93|-0.47||Hypotheses were tested at significance level of 0.025, which is half of overall alpha of 0.05, split equally between 2 treatment comparisons. This maintained the overall type-I (alpha) at 5%. There was no a priori assumption on testing order.|ANCOVA|ANCOVA that included treatment group and geographic region as fixed effects along with baseline HbA1c as covariate.|The primary analysis consisted of the pair-wise comparisons between each dose of empagliflozin versus placebo using the adjusted means from the model.|"The null and alternative hypotheses to be tested:~* H0,2: No difference in change from baseline to Week 18 in HbA1c between empagliflozin 25 mg and placebo~* H1,2: A difference in change from baseline to Week 18 in HbA1c between empagliflozin 25 mg and placebo"||-0.47|-0.93|<0.0001
72470253|NCT01011868|144464668|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.518|||<|0.0001|TWO_SIDED|95.0|3.262|9.334|||Regression, Logistic|Logistic regression includes treatment, geographical region and baseline HbA1c.||Empagliflozin 10 mg vs Placebo at 18 weeks||9.334|3.262|<0.0001
72470254|NCT01011868|144464668|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.883|||<|0.0001|TWO_SIDED|95.0|2.859|8.338|||Regression, Logistic|Logistic regression includes treatment, geographical region and baseline HbA1c||Empagliflozin 25 mg vs Placebo at 18 weeks||8.338|2.859|<0.0001
72470255|NCT01011868|144464668|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.471|||<|0.0001|TWO_SIDED|95.0|2.077|5.802|||Regression, Logistic|Logistic regression includes treatment, geographical region and baseline HbA1c||Empagliflozin 10 mg vs Placebo at 54 weeks||5.802|2.077|<0.0001
72470256|NCT01011868|144464668|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.825|||<|0.0001|TWO_SIDED|95.0|2.268|6.451|||Regression, Logistic|Logistic regression includes treatment, geographical region and baseline HbA1c||Empagliflozin 25 mg vs Placebo at 54 weeks||6.451|2.268|<0.0001
72470257|NCT01011868|144464668|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.802||||0.0002|TWO_SIDED|95.0|1.639|4.789|||Regression, Logistic|Logistic regression includes treatment, geographical region and baseline HbA1c||Empagliflozin 10 mg vs Placebo at 78 weeks||4.789|1.639|0.0002
72470258|NCT01011868|144464668|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.527|||<|0.0001|TWO_SIDED|95.0|2.051|6.066|||Regression, Logistic|Logistic regression includes treatment, geographical region and baseline HbA1c||Empagliflozin 25 mg vs Placebo at 78 weeks||6.066|2.051|<0.0001
72470259|NCT01011868|144464669|SUPERIORITY_OR_OTHER||Adjusted mean difference|-28.4|STANDARD_ERROR_OF_MEAN|4.65|<|0.0001|TWO_SIDED|95.0|-37.54|-19.27|||Mixed Models Analysis|Model includes, baseline FPG, baseline HbA1c as covariates, geographic region, treatment, visit and visit by treatment interaction as fixed effects||Change from BL at week 18 - Empagliflozin 10 mg vs Placebo||-19.27|-37.54|<0.0001
72470260|NCT01011868|144464669|SUPERIORITY_OR_OTHER||Adjusted mean difference|-34.21|STANDARD_ERROR_OF_MEAN|4.81|<|0.0001|TWO_SIDED|95.0|-43.67|-24.76|||Mixed Models Analysis|Model includes, baseline FPG, baseline HbA1c as covariates, geographic region, treatment, visit and visit by treatment interaction as fixed effects||Change from BL at week 18 - Empagliflozin 25 mg vs Placebo at 18 weeks||-24.76|-43.67|<0.0001
72470261|NCT01011868|144464669|SUPERIORITY_OR_OTHER||Adjusted mean difference|-10.75|STANDARD_ERROR_OF_MEAN|5.02||0.0328|TWO_SIDED|95.0|-20.62|-0.89|||Mixed Models Analysis|Model includes, baseline FPG, baseline HbA1c as covariates, geographic region, treatment, visit and visit by treatment interaction as fixed effects||Change from BL at week 54 - Empagliflozin 10 mg vs Placebo at 18 weeks||-0.89|-20.62|0.0328
72470262|NCT01011868|144464669|SUPERIORITY_OR_OTHER||Adjusted mean difference|-19.16|STANDARD_ERROR_OF_MEAN|5.16||0.0002|TWO_SIDED|95.0|-29.31|-9.01|||Mixed Models Analysis|Model includes, baseline FPG, baseline HbA1c as covariates, geographic region, treatment, visit and visit by treatment interaction as fixed effects||Change from BL at week 54 - Empagliflozin 25 mg vs Placebo||-9.01|-29.31|0.0002
72470263|NCT01011868|144464669|SUPERIORITY_OR_OTHER||Adjusted mean difference|-5.03|STANDARD_ERROR_OF_MEAN|5.07||0.3216|TWO_SIDED|95.0|-15.01|4.94|||Mixed Models Analysis|Model includes, baseline FPG, baseline HbA1c as covariates, geographic region, treatment, visit and visit by treatment interaction as fixed effects||Change from BL at week 78 - Empagliflozin 10 mg vs Placebo||4.94|-15.01|0.3216
72470264|NCT01011868|144464669|SUPERIORITY_OR_OTHER||Adjusted mean difference|-11.95|STANDARD_ERROR_OF_MEAN|5.23||0.0229|TWO_SIDED|95.0|-22.24|-1.67|||Mixed Models Analysis|Model includes, baseline FPG, baseline HbA1c as covariates, geographic region, treatment, visit and visit by treatment interaction as fixed effects||Change from BL at week 78 - Empagliflozin 25 mg vs Placebo||-1.67|-22.24|0.0229
72470265|NCT01011868|144464670|SUPERIORITY_OR_OTHER||Adjusted mean difference|-25.12|STANDARD_ERROR_OF_MEAN|5.22|<|0.0001|TWO_SIDED|95.0|-35.38|-14.86|||Mixed Models Analysis|Model includes, baseline FPG, baseline HbA1c as covariates, geographic region, treatment, visit and visit by treatment interaction as fixed effects||Change from BL at week 18 - Empagliflozin 10 mg vs Placebo||-14.86|-35.38|<0.0001
72470266|NCT01011868|144464670|SUPERIORITY_OR_OTHER||Adjusted mean difference|-31.01|||<|0.0001|TWO_SIDED|95.0|-41.62|-20.39|||Mixed Models Analysis|Model includes, baseline FPG, baseline HbA1c as covariates, geographic region, treatment, visit and visit by treatment interaction as fixed effects||Change from BL at week 18 - Empagliflozin 25 mg vs Placebo||-20.39|-41.62|<0.0001
72470267|NCT01011868|144464670|SUPERIORITY_OR_OTHER||Adjusted mean difference|-10.2|STANDARD_ERROR_OF_MEAN|5.15|<|0.0484|TWO_SIDED|95.0|-20.33|-0.07|||Mixed Models Analysis|Model includes, baseline FPG, baseline HbA1c as covariates, geographic region, treatment, visit and visit by treatment interaction as fixed effects||Change from BL at week 54 - Empagliflozin 10 mg vs Placebo||-0.07|-20.33|<0.0484
72470268|NCT01011868|144464670|SUPERIORITY_OR_OTHER||Adjusted mean difference|-19.42|STANDARD_ERROR_OF_MEAN|5.3||0.0003|TWO_SIDED|95.0|-29.84|-8.99|||Mixed Models Analysis|Model includes, baseline FPG, baseline HbA1c as covariates, geographic region, treatment, visit and visit by treatment interaction as fixed effects||Change from BL at week 54 - Empagliflozin 25 mg vs Placebo||-8.99|-29.84|0.0003
72470269|NCT01011868|144464670|SUPERIORITY_OR_OTHER||Adjusted mean difference|-4.73|STANDARD_ERROR_OF_MEAN|5.07||0.3517||95.0|-14.71|5.25|||Mixed Models Analysis|Model includes, baseline FPG, baseline HbA1c as covariates, geographic region, treatment, visit and visit by treatment interaction as fixed effects||Change from BL at week 78 - Empagliflozin 10 mg vs Placebo||5.25|-14.71|0.3517
72470270|NCT01011868|144464670|SUPERIORITY_OR_OTHER||Adjusted mean difference|-12.39|STANDARD_ERROR_OF_MEAN|5.23||0.0185|TWO_SIDED|95.0|-22.69|-2.1|||Mixed Models Analysis|Model includes, baseline FPG, baseline HbA1c as covariates, geographic region, treatment, visit and visit by treatment interaction as fixed effects||Change from BL at week 78 - Empagliflozin 25 mg vs Placebo||-2.10|-22.69|0.0185
72470271|NCT01011868|144464671|SUPERIORITY_OR_OTHER||Adjusted mean difference|-5.58|STANDARD_ERROR_OF_MEAN|2.4||0.0213|TWO_SIDED|95.0|-10.32|-0.84|||Mixed Models Analysis||Week 54 model includes, baseline basal insulin, baseline HbA1c as linear covariate(s), geographical region, treatment, visit and visit by treatment interaction as fixed effects.|Empagliflozin versus Placebo 10 mg at 54 weeks||-0.84|-10.32|0.0213
72505046|NCT01380093|144541431|SUPERIORITY_OR_OTHER||LS Mean Difference|29.1|||<|0.0001|TWO_SIDED|95.0|24.6|33.7||p-value adjusted for multiple comparisons with Hochberg adjustment.|Mixed Models Analysis|||LS mean and 95% CI were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||33.7|24.6|<0.0001
72470272|NCT01011868|144464671|SUPERIORITY_OR_OTHER||Adjusted mean difference|-5.69|STANDARD_ERROR_OF_MEAN|2.49||0.0237|TWO_SIDED|95.0|-10.62|-0.77|||Mixed Models Analysis||Week 54 model includes, baseline basal insulin, baseline HbA1c as linear covariate(s), geographical region, treatment, visit and visit by treatment interaction as fixed effect(s).|Empagliflozin versus Placebo 25 mg at 54 weeks||-0.77|-10.62|0.0237
72470273|NCT01011868|144464671|SUPERIORITY_OR_OTHER||Adjusted mean difference|-6.66|STANDARD_ERROR_OF_MEAN|2.18||0.0024|TWO_SIDED|97.5|-11.56|-1.77||Hierarchical testing approach was applied to Empagliflozin 10 mg vs Placebo. If null hypothesis is rejected for the primary endpoint, at 0.025 (2-sided), testing of the key secondary endpoints continued in a hierarchical fashion for the same dose.|ANCOVA|Model for Week 78 includes baseline basal insulin, baseline HbA1c as linear covariate(s) and geographical region, treatment as fixed effect(s)||"Empagliflozin versus Placebo 10 mg at 78 weeks~H0,1a: No difference in change from baseline to Week 78 in basal insulin dose between Empagliflozin 10 mg and placebo H1,1a: A difference in change from baseline to Week 78 in basal insulin dose between Empagliflozin 10 mg and placebo"||-1.77|-11.56|0.0024
72622506|NCT03829514|144775035|OTHER|||||||0.05|||||||t-test, 2 sided|Signal intensity data were loess normalized and normalized data were used to perform a limma t-test with empirical Bayes smoothing to standard errors|||Proteins were identified and quantified using EncyclopeDIA and visualized with Scaffold DIA using 1% false discovery thresholds at both the protein and peptide level. Protein exclusive intensity values were assessed for quality using an in-house ProteiNorm app, a tool for systematic evaluation of normalization methods, imputation of missing values and comparisons of multiple differential abundance methods . Cyclic loess normalization. The normalized data were used to perform statistical analysis using linear models for microarray data (limma) with empirical Bayes (eBayes) smoothing to the standard errors. Proteins with p-value \< 0.05 were considered significant.|||0.05
72505047|NCT01380093|144541432|SUPERIORITY_OR_OTHER||LS Mean Difference|-51.1|||<|0.0001|TWO_SIDED|95.0|-61.2|-41.0||p-value adjusted for multiple comparisons with Hochberg adjustment. At least one primary outcome for each of drug liking and high was required to be significant with adjusted p-value less than or equal to 0.05.|Mixed Models Analysis|||LS mean and 95% CI were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-41.0|-61.2|<0.0001
72505048|NCT01380093|144541432|SUPERIORITY_OR_OTHER||LS Mean Difference|24.6|||<|0.0001|TWO_SIDED|95.0|14.5|34.6||p-value adjusted for multiple comparisons with Hochberg adjustment.|Mixed Models Analysis|||LS mean and 95% CI were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||34.6|14.5|<0.0001
72505049|NCT01380093|144541432|SUPERIORITY_OR_OTHER||LS Mean Difference|75.7|||<|0.0001|TWO_SIDED|95.0|65.6|85.8||p-value adjusted for multiple comparisons with Hochberg adjustment.|Mixed Models Analysis|||LS mean and 95% CI were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||85.8|65.6|<0.0001
72470274|NCT01011868|144464671|SUPERIORITY_OR_OTHER||Adjusted mean difference|-5.92|STANDARD_ERROR_OF_MEAN|2.25||0.009|TWO_SIDED|97.5|-11.0|-0.85||Hierarchical testing approach was applied to Empagliflozin 25 mg vs Placebo. If null hypothesis is rejected for the primary endpoint, at 0.025 (2-sided), testing of the key secondary endpoints continued in a hierarchical fashion for the same dose.|ANCOVA|Model for Week 78 includes baseline basal insulin, baseline HbA1c as linear covariate(s) and geographical region, treatment as fixed effect(s)||"Empagliflozin versus Placebo 25 mg at 78 weeks~H0,1a: No difference in change from baseline to Week 78 in basal insulin dose between Empagliflozin 25 mg and placebo H1,1a: A difference in change from baseline to Week 78 in basal insulin dose between Empagliflozin 25 mg and placebo"||-0.85|-11.00|0.0090
72470275|NCT01011868|144464672|SUPERIORITY_OR_OTHER||Adjusted mean difference|-2.04|STANDARD_ERROR_OF_MEAN|0.95||0.032|TWO_SIDED|95.0|-3.9|-0.18|||Mixed Models Analysis||Model includes baseline weight, baseline HbA1c as linear covariates, geographical region, treatment, visit and visit by treatment interaction as fixed effects|Change from BL at week 18 - Empagliflozin 10 mg vs Placebo||-0.18|-3.90|0.0320
72470276|NCT01011868|144464672|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.87|STANDARD_ERROR_OF_MEAN|0.99||0.3818|TWO_SIDED|95.0|-2.81|1.08|||Mixed Models Analysis||Model includes baseline weight, baseline HbA1c as linear covariates, geographical region, treatment, visit and visit by treatment interaction as fixed effects|Change from BL at week 18 - Empagliflozin 25 mg vs Placebo||1.08|-2.81|0.3818
72470277|NCT01011868|144464672|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.97|STANDARD_ERROR_OF_MEAN|0.47|<|0.0001|TWO_SIDED|95.0|-2.89|-1.05|||Mixed Models Analysis||Model includes baseline weight, baseline HbA1c as linear covariates, geographical region, treatment, visit and visit by treatment interaction as fixed effects|Change from BL at week 54 - Empagliflozin 10 mg vs Placebo||-1.05|-2.89|<0.0001
72470278|NCT01011868|144464672|SUPERIORITY_OR_OTHER||Adjusted mean difference|-2.17|STANDARD_ERROR_OF_MEAN|0.49|<|0.0001|TWO_SIDED|95.0|-3.13|-1.22|||Mixed Models Analysis||Model includes baseline weight, baseline HbA1c as linear covariates, geographical region, treatment, visit and visit by treatment interaction as fixed effects|Change from BL at week 54 - Empagliflozin 25 mg vs Placebo||-1.22|-3.13|<0.0001
72470279|NCT01011868|144464672|SUPERIORITY_OR_OTHER||Adjusted mean difference|-3.63|STANDARD_ERROR_OF_MEAN|1.1||0.0012|TWO_SIDED|95.0|-5.81|-1.45|||Mixed Models Analysis||Model includes baseline weight, baseline HbA1c as linear covariates, geographical region, treatment, visit and visit by treatment interaction as fixed effects|Change from BL at week 78 - Empagliflozin 10 mg vs Placebo||-1.45|-5.81|0.0012
72470280|NCT01011868|144464672|SUPERIORITY_OR_OTHER||Adjusted mean difference|-3.12|STANDARD_ERROR_OF_MEAN|1.15||0.0073|TWO_SIDED|95.0|-5.39|-0.85|||Mixed Models Analysis|Model includes, baseline weight, baseline HbA1c as covariates, geographic region, treatment, visit and visit by treatment interaction as fixed effects|Model includes baseline weight, baseline HbA1c as linear covariates, geographical region, treatment, visit and visit by treatment interaction as fixed effects|Change from BL at week 78 - Empagliflozin 25 mg vs Placebo||-0.85|-5.39|0.0073
72470281|NCT01011868|144464674|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.47|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001|TWO_SIDED|95.0|-0.68|-0.26|||Mixed Models Analysis||Model includes baseline HbA1c as linear covariate(s), geographical region, treatment, visit and visit by treatment interaction as fixed effect(s).|Change from BL at week 54 - Empagliflozin 10 mg vs Placebo||-0.26|-0.68|<0.0001
72505050|NCT01380093|144541433|SUPERIORITY_OR_OTHER||LS Mean Difference|-8.9|||<|0.0001|TWO_SIDED|95.0|-11.8|-6.0|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-6.0|-11.8|<0.0001
72505051|NCT01380093|144541433|SUPERIORITY_OR_OTHER||LS Mean Difference|5.2||||0.0006|TWO_SIDED|95.0|2.3|8.1|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||8.1|2.3|0.0006
72470282|NCT01011868|144464674|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.74|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001|TWO_SIDED|95.0|-0.95|-0.52|||Mixed Models Analysis||Model includes baseline HbA1c as linear covariate(s), geographical region, treatment, visit and visit by treatment interaction as fixed effect(s).|Change from BL at week 54 - Empagliflozin 25 mg vs Placebo||-0.52|-0.95|<0.0001
72470283|NCT01011868|144464674|NON_INFERIORITY_OR_EQUIVALENCE|"For non-inferiority, a one-sided test at the significance level of 0.0125 was performed using a chosen margin of 0.3% difference between each dose of empagliflozin and placebo.~If the non-inferiority of empagliflozin to placebo with respect to change from baseline in HbA1c after 78 weeks of treatment could be concluded for a specific dose, subsequent testing of superiority was performed at the significance level of 0.025 for the relevant empagliflozin dose versus placebo comparison."|Adjusted mean difference|-0.46|STANDARD_ERROR_OF_MEAN|0.12||0.0001|TWO_SIDED|97.5|-0.73|-0.19||Hierarchical testing approach was applied to Empagliflozin 10 mg vs Placebo. If null hypothesis is rejected for the primary endpoint, at 0.025 (2-sided), testing of the key secondary endpoints continued in a hierarchical fashion for the same dose.|ANCOVA||Model includes baseline HbA1c as linear covariate(s), geographical region, treatment as fixed effect(s).|"Change from BL at week 78 - Empagliflozin 10 mg vs Placebo~H0,1b: The change from baseline to Week 78 in HbA1c between empagliflozin 10 mg and placebo ≥0.3% H1,1b: The change from baseline to Week 78 in HbA1c between empagliflozin 10 mg and placebo \<0.3%"||-0.19|-0.73|0.0001
72505052|NCT01380093|144541433|SUPERIORITY_OR_OTHER||LS Mean Difference|14.1|||<|0.0001|TWO_SIDED|95.0|11.2|17.0|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||17.0|11.2|<0.0001
72505053|NCT01380093|144541434|SUPERIORITY_OR_OTHER||LS Mean Difference|-48.8|||<|0.0001|TWO_SIDED|95.0|-62.0|-35.5|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-35.5|-62.0|<0.0001
72505054|NCT01380093|144541434|SUPERIORITY_OR_OTHER||LS Mean Difference|29.0|||<|0.0001|TWO_SIDED|95.0|15.8|42.3|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||42.3|15.8|<0.0001
72395200|NCT05355805|144297054|SUPERIORITY||Risk Difference (RD)|4.79|STANDARD_ERROR_OF_MEAN|7.294||0.5116|TWO_SIDED|||||The estimated risk difference divided by the standard error was used as the test statistic and a p-value calculated assuming that the test statistic follows a standard normal distribution under the null hypothesis.|Cochran-Mantel-Haenszel|||"The common risk difference between placebo QW/Q2W and the izokibep 160 mg Q2W arm among the four strata, prior biologic/JAK inhibitor use for HS (Yes/No) and Hurley Stage (II or III), used for randomization and associated standard error will be estimated by combining the observed risk differences using Cochran-Mantel-Haenszel weighting.~Non-response imputation was used for participants with missing HiSCR90."||||0.5116
72470284|NCT01011868|144464674|NON_INFERIORITY_OR_EQUIVALENCE|"For non-inferiority, a one-sided test at the significance level of 0.0125 was performed using a chosen margin of 0.3% difference between each dose of empagliflozin and placebo.~If the non-inferiority of empagliflozin to placebo with respect to change from baseline in HbA1c after 78 weeks of treatment could be concluded for a specific dose, subsequent testing of superiority was performed at the significance level of 0.025 for the relevant empagliflozin dose versus placebo comparison."|Adjusted mean difference|-0.62|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|97.5|-0.9|-0.34||Hierarchical testing approach was applied to Empagliflozin 25 mg vs Placebo. If null hypothesis is rejected for the primary endpoint, at 0.025 (2-sided), testing of the key secondary endpoints continued in a hierarchical fashion for the same dose.|ANCOVA||Model includes baseline HbA1c as linear covariate(s), geographical region, treatment as fixed effect(s).|"Change from BL at week 78 - Empagliflozin 25 mg vs Placebo~H0,1b: The change from baseline to Week 78 in HbA1c between empagliflozin 25 mg and placebo ≥0.3% H1,1b: The change from baseline to Week 78 in HbA1c between empagliflozin 25 mg and placebo \<0.3%"||-0.34|-0.90|<0.0001
72470285|NCT01011868|144464676|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.096||||0.0005|TWO_SIDED|95.0|1.846|9.088|||Regression, Logistic|Logistic regression includes treatment, geographical region and baseline HbA1c||Empagliflozin 10 mg vs Placebo at 18 weeks||9.088|1.846|0.0005
72470286|NCT01011868|144464676|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.636||||0.0002|TWO_SIDED|95.0|2.083|10.321|||Regression, Logistic|Logistic regression includes treatment, geographical region and baseline HbA1c||Empagliflozin 25 mg vs Placebo at 18 weeks||10.321|2.083|0.0002
72470287|NCT01011868|144464676|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.75||||0.1248|TWO_SIDED|95.0|0.856|3.575|||Regression, Logistic|Logistic regression includes treatment, geographical region and baseline HbA1c||Empagliflozin 10 mg vs Placebo at 54 weeks||3.575|0.856|0.1248
72470288|NCT01011868|144464676|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.423||||0.0132|TWO_SIDED|95.0|1.203|4.879|||Regression, Logistic|Logistic regression includes treatment, geographical region and baseline HbA1c||Empagliflozin 25 mg vs Placebo at 54 weeks||4.879|1.203|0.0132
72470289|NCT01011868|144464676|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.939||||0.0986|TWO_SIDED|95.0|0.884|4.256|||Regression, Logistic|Logistic regression includes treatment, geographical region and baseline HbA1c||Empagliflozin 10 mg vs Placebo at 78 weeks||4.256|0.884|0.0986
72470290|NCT01011868|144464676|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.239||||0.0024|TWO_SIDED|95.0|1.518|6.911|||Regression, Logistic|Logistic regression includes treatment, geographical region and baseline HbA1c||Empagliflozin 25 mg vs Placebo at 78 weeks||6.911|1.518|0.0024
72470291|NCT01782690|144464695|SUPERIORITY_OR_OTHER|||||||0.2361|||||||Log Rank|||Comparison of Rash=Yes versus Rash=No within Erlotinib plus Gemcitabine arm||||0.2361
72395201|NCT05355805|144297055|SUPERIORITY||Risk Difference (RD)|13.67|STANDARD_ERROR_OF_MEAN|7.019||0.0514|TWO_SIDED|||||The estimated risk difference divided by the standard error was used as the test statistic and a p-value calculated assuming that the test statistic follows a standard normal distribution under the null hypothesis.|Cochran-Mantel-Haenszel|||"The common risk difference between placebo QW/Q2W and the izokibep 160 mg QW arm among the four strata, prior biologic/JAK inhibitor use for HS (Yes/No) and Hurley Stage (II or III), used for randomization and associated standard error will be estimated by combining the observed risk differences using Cochran-Mantel-Haenszel weighting.~Non-response imputation was used for participants with missing HiSCR100."||||0.0514
72470292|NCT04121897|144464718|OTHER|||||||0.024|||||||t-test, 2 sided|||||||0.024
72470293|NCT01948076|144464735|SUPERIORITY_OR_OTHER|||||||0.11||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.11
72470294|NCT01948076|144464736|SUPERIORITY_OR_OTHER|||||||0.043|TWO_SIDED|95.0|||||McNemar|||||||0.043
72470295|NCT01210651|144464764|SUPERIORITY_OR_OTHER|||||||0.034||||||Analysis performed via Stata v14.1. Alpha was 2-tailed. P-value was calculated, with p-value \< 0.05 required a priori to reject the null hypothesis.|Regression, Generalized Least Squares|||A random-effects, generalized least squares (GLS) regression model for depression severity was used to analyze participant BDI scores measured just before 1st assigned session at 0 wks, and just after assigned sessions at 2 wks, 4 wks, 6 wks and 8 wks. BDI Scores were modeled as correlated within participants but independent between participants. The GLS regression model tested the null hypothesis that no significant effects on BDI scores would be found by intervention and intervention-by-time.||||0.034
72470296|NCT01210651|144464765|SUPERIORITY_OR_OTHER|||||||0.02||||||Analysis performed via Stata v14.1, with P-value calculated using a t-distribution and assuming unequal variances in the two samples. Alpha was two-tailed. P-value \< 0.05 was required a priori to reject the null hypothesis.|t-test, 2 sided|||Statistical analysis examined Total Change Scores on BDI, using two sample t-test to evaluate the null hypothesis that the Total Change Score on BDI for each intervention group would be statistically comparable.||||0.02
72470297|NCT01210651|144464766|SUPERIORITY_OR_OTHER|||||||0.018||||||Analysis performed via Stata v14.1. Alpha was 2-tailed. P-value was calculated, with a p-value \< 0.05 required a priori to reject the null hypothesis.|Fisher Exact|||Fisher's Exact test evaluated null hypothesis that the proportion of study completers with remitted depression would be statistically comparable in the 2 intervention groups.||||0.018
72505055|NCT01380093|144541434|SUPERIORITY_OR_OTHER||LS Mean Difference|77.8|||<|0.0001|TWO_SIDED|95.0|64.5|91.0|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||91.0|64.5|<0.0001
72470298|NCT01210651|144464767|SUPERIORITY_OR_OTHER|||||||0.5||||||Analysis performed via Stata v14.1, with P-value calculated using a t-distribution and assuming unequal variances in the two samples. Alpha was two-tailed. P-value \< 0.05 was required a priori to reject the null hypothesis.|t-test, 2 sided|||Statistical analysis examined Total Change Scores on GSES, using an independent samples t-test to evaluate null hypothesis that Total Change Score on GSES for each intervention group would be statistically comparable.||||0.50
72470299|NCT01210651|144464768|SUPERIORITY_OR_OTHER|||||||0.053||||||Analysis performed via Stata v14.1, with P-value calculated using a t-distribution and assuming unequal variances in the two samples. Alpha was two-tailed. P-value \< 0.05 was required a priori to reject the null hypothesis.|t-test, 2 sided|||Statistical analysis examined Total Change Scores on RSES, using an independent samples t-test to evaluate null hypothesis that Total Change Score on RSES for each intervention group would be statistically comparable.||||0.053
72470300|NCT04855734|144464804|SUPERIORITY||Mean ratio|0.962||||0.835|TWO_SIDED|95.0|0.661|1.396||Threshold for significance was \<0.05.|Mixed Models Analysis|||||1.396|0.661|0.835
72470301|NCT04855734|144464805|SUPERIORITY||Mean ratio|0.826||||0.032|TWO_SIDED|95.0|0.75|0.986||\<0.05 was threshold for significance level.|Mixed Models Analysis|||Meaning/Peace subscale which was a primary outcome.||0.986|0.75|0.032
72470302|NCT04855734|144464811|SUPERIORITY||Mean ratio|1.052||||0.284|TWO_SIDED|95.0|0.959|1.157||\<0.05 threshold for significance level.|Mixed Models Analysis|||Caregiver strain subscale scores at 3 months post-intervention comparing intervention to TAU, controlling for baseline levels.||1.157|0.959|0.284
72505056|NCT01380093|144541435|SUPERIORITY_OR_OTHER||LS Mean Difference|-68.6|||<|0.0001|TWO_SIDED|95.0|-95.0|-42.2|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-42.2|-95.0|<0.0001
72505057|NCT01380093|144541435|SUPERIORITY_OR_OTHER||LS Mean Difference|56.5|||<|0.0001|TWO_SIDED|95.0|30.1|82.8|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||82.8|30.1|<0.0001
72470303|NCT04855734|144464811|SUPERIORITY||Mean ratioj|0.931||||0.228|TWO_SIDED|95.0|0.827|1.048||\<0.05 threshold for significance level.|Mixed Models Analysis|||Caregiver distress subscale controlling for baseline levels.||1.048|0.827|0.228
72505058|NCT01380093|144541435|SUPERIORITY_OR_OTHER||LS Mean Difference|125.1|||<|0.0001|TWO_SIDED|95.0|98.7|151.5|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||151.5|98.7|<0.0001
72505059|NCT01380093|144541436|SUPERIORITY_OR_OTHER||LS Mean Difference|-76.0||||0.0001|TWO_SIDED|95.0|-112.8|-39.2|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-39.2|-112.8|0.0001
72505060|NCT01380093|144541436|SUPERIORITY_OR_OTHER||LS Mean Difference|66.5||||0.0006|TWO_SIDED|95.0|29.8|103.2|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||103.2|29.8|0.0006
72470304|NCT04855734|144464811|SUPERIORITY||Mean ratio|0.984||||0.504|TWO_SIDED|95.0|0.94|1.032||\<0.05 significance level.|Mixed Models Analysis|||Family well-being subscale controlling for baseline levels.||1.032|0.94|0.504
72470305|NCT04855734|144464811|SUPERIORITY||Mean ratio|0.995||||0.741|TWO_SIDED|95.0|0.967|1.024||\<0.05 significance level.|Mixed Models Analysis|||Positive Caregiving Appraisals subscale at 3 month follow up, controlling for baseline levels.||1.024|0.967|0.741
72470306|NCT00078377|144464940|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.8||||0.0024||95.0|1.02|4.61|||ANCOVA|The corresponding baseline value as a covariate.||Statistical data is for the Armodafinil Combined treatment (250 mg/day and 150 mg/day groups) compared to the placebo treatment group||4.61|1.02|0.0024
72470307|NCT00078377|144464941|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
72470308|NCT00953147|144464942|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.69|||<|0.0001|TWO_SIDED|95.0|0.35|1.04||The p-value from primary outcome was adjusted at alpha=0.025.|ANCOVA|||The null hypothesis is that there is no difference in primary outcome when compare active to placebo group. The alternative hypothesis is that there is a difference in primary outcome when compare active to placebo group. It was estimated that 200 subjects per group will provide at least 85% power to detect a difference between treatment groups of 0.7 in the change from baseline in iTNSS with a two-sided alpha level of 0.025.||1.04|0.35|<0.0001
72505061|NCT01380093|144541436|SUPERIORITY_OR_OTHER||LS Mean Difference|142.5|||<|0.0001|TWO_SIDED|95.0|105.7|179.3|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||179.3|105.7|<0.0001
72505062|NCT01380093|144541437|SUPERIORITY_OR_OTHER||LS Mean Difference|-86.2||||0.0011|TWO_SIDED|95.0|-136.5|-35.9|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-35.9|-136.5|0.0011
72505063|NCT01380093|144541437|SUPERIORITY_OR_OTHER||LS Mean Difference|69.8||||0.0071|TWO_SIDED|95.0|19.7|120.0|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||120.0|19.7|0.0071
72505064|NCT01380093|144541437|SUPERIORITY_OR_OTHER||LS Mean Difference|156.0|||<|0.0001|TWO_SIDED|95.0|105.7|206.3|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||206.3|105.7|<0.0001
72505065|NCT01380093|144541438|SUPERIORITY_OR_OTHER||LS Mean Difference|2.0||||0.1254|TWO_SIDED|95.0|-0.6|4.7|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||4.7|-0.6|0.1254
72470309|NCT00953147|144464942|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.54||||0.0005|TWO_SIDED|95.0|0.24|0.84||The p-value from primary outcome was adjusted at alpha=0.025.|ANCOVA|||The null hypothesis is that there is no difference in primary outcome when compare active to placebo group. The alternative hypothesis is that there is a difference in primary outcome when compare active to placebo group. It was estimated that 200 subjects per group will provide at least 85% power to detect a difference between treatment groups of 0.7 in the change from baseline in iTNSS with a two-sided alpha level of 0.025.||0.84|0.24|0.0005
72470310|NCT00953147|144464943|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.58||||0.0014|TWO_SIDED|95.0|0.25|0.92|||ANCOVA|||Dmitrienko's tree-structured gatekeeping method was used for multiple comparisons||0.92|0.25|0.0014
72470311|NCT00953147|144464943|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.42||||0.0122|TWO_SIDED|95.0|0.12|0.72|||ANCOVA|||Dmitrienko's tree-structured gatekeeping method was used for multiple comparisons||0.72|0.12|0.0122
72470312|NCT00790400|144464956|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Clopper-Pearson|||||||<0.0001
72470313|NCT00078338|144464966|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.943||||0.643|TWO_SIDED|95.0|0.74|1.21|||Cox proportional hazards model|||||1.21|0.74|0.643
72470314|NCT03258723|144464967|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||Within group change from baseline assessed on matched cases.||||<0.0001
72470315|NCT03258723|144464968|SUPERIORITY|||||||0.0005|||||||t-test, 2 sided|||Within group change from baseline assessed on matched cases.||||0.0005
72470316|NCT03258723|144464969|SUPERIORITY|||||||0.1809|||||||t-test, 2 sided|||Within group change from baseline assessed on matched cases.||||0.1809
72470317|NCT03258723|144464970|SUPERIORITY|||||||0.0973|||||||t-test, 2 sided|||Within group change from baseline assessed on matched cases.||||0.0973
72470318|NCT03258723|144464972|SUPERIORITY|||||||0.1992|||||||t-test, 2 sided|||Within subject change on matched cases.||||0.1992
72470319|NCT03258723|144464973|SUPERIORITY|||||||0.7017|||||||t-test, 2 sided|||Within subject change on matched cases.||||0.7017
72470320|NCT03258723|144464974|SUPERIORITY|||||||0.1573|||||||McNemar|||Within group change from baseline assessed on matched cases in low activity group at baseline.||||0.1573
72470321|NCT03258723|144464974|SUPERIORITY|||||||0.4328|||||||McNemar|||Within group change from baseline assessed on matched cases in medium activity group at baseline.||||0.4328
72470322|NCT03258723|144464974|SUPERIORITY|||||||0.6698|||||||McNemar|||Within group change from baseline assessed on matched cases in high activity group at baseline.||||0.6698
72470323|NCT03258723|144464975|SUPERIORITY|||||||0.5271|||||||t-test, 2 sided|||Within group change from baseline assessed on matched cases.||||0.5271
72470324|NCT03258723|144464976|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||Within group change from baseline assessed on matched cases.||||<0.0001
72470325|NCT01606319|144464980|SUPERIORITY_OR_OTHER||relative rate|0.94||||0.67|TWO_SIDED|95.0|0.69|1.28|||log-linear model|log-linear model in which the number of exacerbations was assumed to follow a negative binomial distribution|relative rate with acetaminophen in the numerator and ibuprofen in the denominator|||1.28|.69|0.67
72470326|NCT01606319|144464981|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01||||0.5|TWO_SIDED|95.0|-0.039|0.0019|||ANCOVA|||||.0019|-0.039|0.5
72505066|NCT01380093|144541438|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.0||||0.4592|TWO_SIDED|95.0|-3.6|1.6|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||1.6|-3.6|0.4592
72505067|NCT01380093|144541438|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.0||||0.0251|TWO_SIDED|95.0|-5.6|-0.4|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-0.4|-5.6|0.0251
72505068|NCT01380093|144541439|SUPERIORITY_OR_OTHER||LS Mean Difference|-15.4|||<|0.0001|TWO_SIDED|95.0|-19.9|-11.0|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-11.0|-19.9|<0.0001
72505069|NCT01380093|144541439|SUPERIORITY_OR_OTHER||LS Mean Difference|9.3|||<|0.0001|TWO_SIDED|95.0|4.8|13.7|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||13.7|4.8|<0.0001
72470327|NCT01606319|144464982|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2||||0.69|TWO_SIDED|95.0|-0.9|0.6|||ANCOVA|||||0.6|-0.9|0.69
72470328|NCT01606319|144464983|SUPERIORITY_OR_OTHER||relative rate|0.99||||0.94|TWO_SIDED|95.0|0.72|1.37|||log-linear model|log-linear model in which the number of exacerbations was assumed to follow a negative binomial distribution|relative rate with acetaminophen in the numerator and ibuprofen in the denominator|||1.37|0.72|.94
72470329|NCT01634269|144464986|SUPERIORITY_OR_OTHER_LEGACY||Proportion of IF implanted subjects|87.5||||0.002|TWO_SIDED|95.0|61.7|98.4|||Exact binomial|||||98.4|61.7|0.002
72470330|NCT01607879|144465068|SUPERIORITY|||||||0.1497|||||||t-test, 1 sided|||||||0.1497
72470331|NCT01607879|144465069|SUPERIORITY|||||||0.17|||||||t-test, 2 sided|||||||0.17
72470332|NCT01607879|144465070|SUPERIORITY|||||||0.75|||||||t-test, 2 sided|||||||0.75
72470333|NCT01607879|144465071|SUPERIORITY|||||||0.925|||||||Wilcoxon (Mann-Whitney)|||||||0.925
72470334|NCT01607879|144465072|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||||||1.0
72470335|NCT03994731|144465077|SUPERIORITY||Stratified difference in proportions|32.31|STANDARD_ERROR_OF_MEAN|8.157|<|0.0001|TWO_SIDED|95.0|16.3|48.3||The 2-sided p-value was calculated assuming the test statistic was distributed as a standard normal random variable.|Cochran-Mantel-Haenszel||Stratified difference (Pegloticase+MTX - Pegloticase+Placebo) is a weighted average of the difference within each stratum. Estimates from the 2 strata (tophi presence at baseline: yes, no) were combined with Cochran-Mantel-Haenszel (CMH) weights.|||48.3|16.3|< 0.0001
72470336|NCT03994731|144465078|SUPERIORITY||response rate difference|29.05|STANDARD_ERROR_OF_MEAN|8.084||0.0003|TWO_SIDED|95.0|13.2|44.9||The 2-sided p-value was calculated assuming the test statistic was distributed as a standard normal random variable.|Cochran-Mantel-Haenszel||response rate difference (Peg+MTX - Peg+Placebo)|||44.9|13.2|0.0003
72470337|NCT03994731|144465079|SUPERIORITY||Difference|22.8||||0.0482|TWO_SIDED|95.0|1.2|44.4||The comparison of complete response between groups is performed using an unstratified chi-squared test.|Chi-squared||Difference (Pegloticase+MTX - Pegloticase+Placebo)|||44.4|1.2|0.0482
72470338|NCT03994731|144465080|SUPERIORITY||Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.084||0.6287|TWO_SIDED|95.0|-0.21|0.13||Based on mixed models repeated measures (MMRM) analysis of covariance (ANCOVA) model including the following terms: baseline value, tophi presence (Y/N), treatment group, visit, visit-by-treatment interaction, and visit-by-baseline value interaction.|MMRM ANCOVA||Difference (Pegloticase+MTX - Pegloticase+Placebo)|||0.13|-0.21|0.6287
72470339|NCT03994731|144465081|SUPERIORITY||Difference|-8.43|STANDARD_ERROR_OF_MEAN|3.766||0.0272|TWO_SIDED|95.0|-15.88|-0.97||Based on mixed models repeated measures (MMRM) analysis of covariance (ANCOVA) model including the following terms: baseline value, tophi presence (Y/N), treatment group, visit, visit-by-treatment interaction, and visit-by-baseline value interaction.|MMRM ANCOVA||Difference (Pegloticase+MTX - Pegloticase+Placebo)|||-0.97|-15.88|0.0272
72470340|NCT03994731|144465082|SUPERIORITY||Difference|-10.16|STANDARD_ERROR_OF_MEAN|2.531||0.0222|TWO_SIDED|95.0|-18.84|-1.48||Based on mixed models repeated measures (MMRM) analysis of covariance (ANCOVA) model including the following terms: baseline value, tophi presence (Y/N), treatment group, visit, visit-by-treatment interaction, and visit-by-baseline value interaction.|MMRM ANCOVA||Difference (Pegloticase+MTX - Pegloticase+Placebo)|||-1.48|-18.84|0.0222
72470341|NCT02838979|144465093|SUPERIORITY||Mean Difference (Final Values)|-0.01|STANDARD_DEVIATION|0.34||0.15|TWO_SIDED|||||P-value for the interaction of treatment and sequence|ANOVA|Two-way ANOVA was used to assess differences between the groups||||||0.15
72470342|NCT02838979|144465094|SUPERIORITY||Mean Difference (Final Values)|-7.39|STANDARD_DEVIATION|22.18||0.86|TWO_SIDED|||||P-value for the interaction of treatment and sequence|ANOVA|Two-way ANOVA was used to assess differences between the groups||||||0.86
72470343|NCT02838979|144465095|SUPERIORITY||Median Difference (Final Values)|-0.1|STANDARD_DEVIATION|1.04||0.44|TWO_SIDED|||||P-value for the interaction of treatment and sequence|ANOVA|Two-way ANOVA was used to assess differences between the groups||||||0.44
72470344|NCT02838979|144465096|SUPERIORITY||Mean Difference (Final Values)|0.06|STANDARD_DEVIATION|0.21||0.36|TWO_SIDED|||||P-value for the interaction of treatment and sequence|ANOVA|Two-way ANOVA was used to assess differences between the groups||||||0.36
72470345|NCT02838979|144465097|SUPERIORITY||Mean Difference (Final Values)|-0.45|STANDARD_DEVIATION|7.87||0.6|TWO_SIDED|||||P-value for the interaction of treatment and sequence|ANOVA|Two-way ANOVA was used to assess differences between the groups||||||0.60
72470346|NCT03812029|144465105|SUPERIORITY|||||||0.0015||||||a priori threshold for statistical significance : \<0.05.|ANCOVA|||||||0.0015
72470347|NCT03812029|144465105|SUPERIORITY|||||||0.0121||||||a priori threshold for statistical significance : \<0.05.|ANCOVA|||||||0.0121
72470348|NCT03812029|144465105|SUPERIORITY|||||||0.0371||||||a priori threshold for statistical significance : \<0.05.|ANCOVA|||||||0.0371
72470349|NCT03812029|144465106|SUPERIORITY|||||||0.003||||||a priori threshold for statistical significance : \<0.05.|Mixed Models Analysis|||||||0.003
72470350|NCT03812029|144465106|SUPERIORITY|||||||0.04||||||a priori threshold for statistical significance : \<0.05.|Mixed Models Analysis|||||||0.04
72470351|NCT03812029|144465107|SUPERIORITY|||||||0.0017||||||a priori threshold for statistical significance : \<0.05.|ANCOVA|||||||0.0017
72470352|NCT03812029|144465107|SUPERIORITY|||||||0.018||||||a priori threshold for statistical significance : \<0.05.|ANCOVA|||||||0.018
72470353|NCT03812029|144465107|SUPERIORITY|||||||0.13||||||a priori threshold for statistical significance : \<0.05.|ANCOVA|||||||0.13
72470354|NCT03812029|144465108|SUPERIORITY|||||||0.001||||||a priori threshold for statistical significance : \<0.05.|ANCOVA|||||||0.001
72470355|NCT03812029|144465108|SUPERIORITY|||||||0.002||||||a priori threshold for statistical significance : \<0.05.|ANCOVA|||||||0.002
72470356|NCT03812029|144465108|SUPERIORITY|||||||0.018||||||a priori threshold for statistical significance : \<0.05.|ANCOVA|||||||0.018
72470357|NCT03812029|144465109|SUPERIORITY|||||||0.09||||||a priori threshold for statistical significance : \<0.05.|Mixed Models Analysis|||||||0.09
72470358|NCT03812029|144465109|SUPERIORITY|||||||0.47||||||a priori threshold for statistical significance : \<0.05.|Mixed Models Analysis|||||||0.47
72470359|NCT03812029|144465109|SUPERIORITY|||||||0.14||||||a priori threshold for statistical significance : \<0.05.|Mixed Models Analysis|||||||0.14
72470360|NCT03812029|144465110|SUPERIORITY||||||<|0.0001||||||a priori threshold for statistical significance : \<0.05.|Mixed Models Analysis|||||||<0.0001
72470361|NCT03812029|144465110|SUPERIORITY||||||<|0.0001||||||a priori threshold for statistical significance : \<0.05.|Mixed Models Analysis|||||||<0.0001
72470362|NCT03812029|144465110|SUPERIORITY|||||||0.0002||||||a priori threshold for statistical significance : \<0.05.|Mixed Models Analysis|||||||0.0002
72470363|NCT03812029|144465111|SUPERIORITY|||||||0.017||||||a priori threshold for statistical significance : \<0.05.|Mixed Models Analysis|||||||0.017
72470364|NCT03812029|144465111|SUPERIORITY|||||||0.0006||||||a priori threshold for statistical significance : \<0.05.|Mixed Models Analysis|||||||0.0006
72470365|NCT03812029|144465111|SUPERIORITY|||||||0.006||||||a priori threshold for statistical significance : \<0.05.|Mixed Models Analysis|||||||0.006
72470366|NCT03812029|144465112|SUPERIORITY|||||||0.16||||||a priori threshold for statistical significance : \<0.05.|Mixed Models Analysis|||||||0.16
72470367|NCT03812029|144465112|SUPERIORITY|||||||0.01||||||a priori threshold for statistical significance : \<0.05.|Mixed Models Analysis|||||||0.01
72470368|NCT03812029|144465112|SUPERIORITY|||||||0.57||||||a priori threshold for statistical significance : \<0.05.|Mixed Models Analysis|||||||0.57
72470369|NCT03812029|144465113|SUPERIORITY|||||||0.0017||||||a priori threshold for statistical significance : \<0.05.|Mixed Models Analysis|||||||0.0017
72470370|NCT03812029|144465113|SUPERIORITY|||||||0.0093||||||a priori threshold for statistical significance : \<0.05.|Mixed Models Analysis|||||||0.0093
72505070|NCT01380093|144541439|SUPERIORITY_OR_OTHER||LS Mean Difference|24.7|||<|0.0001|TWO_SIDED|95.0|20.3|29.1|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||29.1|20.3|<0.0001
72470371|NCT00790205|144465124|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Hazard Ratio of Sitagliptin/Placebo: the between-treatment difference in time to the first primary composite CV outcome measure was assessed by the hazard ratio between the sitagliptin and placebo groups. The confidence interval for the hazard ratio was computed and compared to 1.30, the non-inferiority margin.|Hazard Ratio (HR)|0.98|||<|0.001|TWO_SIDED|95.0|0.88|1.09|||Cox proportional hazards model|Model stratified by region with treatment group only as explanatory variable.||||1.09|0.88|<0.001
72470372|NCT00790205|144465125|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Hazard Ratio of Sitagliptin/Placebo: the between-treatment difference in time to the first primary composite CV outcome measure was assessed by the hazard ratio between the sitagliptin and placebo groups. The confidence interval for the hazard ratio was computed and compared to 1.30, the non-inferiority margin.|Hazard Ratio (HR)|0.98|||<|0.001|TWO_SIDED|95.0|0.89|1.08|||Cox proportional hazards model|Model stratified by region with treatment group only as explanatory variable.||||1.08|0.89|<0.001
72470373|NCT00790205|144465126|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Hazard Ratio of Sitagliptin/Placebo: the between-treatment difference in time to the first primary composite CV outcome measure was assessed by the hazard ratio between the sitagliptin and placebo groups. The confidence interval for the hazard ratio was computed and compared to 1.30, the non-inferiority margin.|Hazard Ratio (HR)|0.99|||<|0.001|TWO_SIDED|95.0|0.89|1.11|||Cox proportional hazards model|Model stratified by region with treatment group only as explanatory variable.||||1.11|0.89|<0.001
72470374|NCT00790205|144465127|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Hazard Ratio of Sitagliptin/Placebo: the between-treatment difference in time to the first primary composite CV outcome measure was assessed by the hazard ratio between the sitagliptin and placebo groups. The confidence interval for the hazard ratio was computed and compared to 1.30, the non-inferiority margin.|Hazard Ratio (HR)|0.99|||<|0.001|TWO_SIDED|95.0|0.89|1.1|||Cox proportional hazards model|Model stratified by region with treatment group only as explanatory variable.||||1.10|0.89|<0.001
72470375|NCT00790205|144465128|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.06||||0.435|TWO_SIDED|95.0|0.91|1.24|||Cox proportional hazards model|||Hazard Ratio of Sitagliptin/Placebo: The between-treatment difference in mortality due to all causes was assessed by the hazard ratio between the Sitagliptin and Placebo groups.||1.24|0.91|0.435
72470376|NCT00790205|144465129|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.01||||0.875|TWO_SIDED|95.0|0.9|1.14|||Cox proportional hazards model|||Hazard Ratio of Sitagliptin/Placebo: The between-treatment difference in mortality due to all causes was assessed by the hazard ratio between the Sitagliptin and Placebo groups.||1.14|0.90|0.875
72470377|NCT00790205|144465130|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.98||||0.858|TWO_SIDED|95.0|0.81|1.19|||Cox proportional hazards model|Model stratified by region with treatment group and history of CHF at baseline as explanatory variables.||Hazard Ratio of Sitagliptin/Placebo: The between-treatment difference in CHF cases requiring hospitalization was assessed by the hazard ratio between the Sitagliptin and Placebo groups.||1.19|0.81|0.858
72470378|NCT00790205|144465131|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.0||||0.983|TWO_SIDED|95.0|0.83|1.2|||Cox proportional hazards model|Model stratified by region with treatment group and history of CHF at baseline as explanatory variables.||Hazard Ratio of Sitagliptin/Placebo: The between-treatment difference in CHF cases requiring hospitalization was assessed by the hazard ratio between the Sitagliptin and Placebo groups.||1.20|0.83|0.983
72395202|NCT05355805|144297055|SUPERIORITY||Risk Difference (RD)|6.56|STANDARD_ERROR_OF_MEAN|6.764||0.3322|TWO_SIDED|||||The estimated risk difference divided by the standard error was used as the test statistic and a p-value calculated assuming that the test statistic follows a standard normal distribution under the null hypothesis.|Cochran-Mantel-Haenszel|||"The common risk difference between placebo QW/Q2W and the izokibep 160 mg Q2W arm among the four strata, prior biologic/JAK inhibitor use for HS (Yes/No) and Hurley Stage (II or III), used for randomization and associated standard error will be estimated by combining the observed risk differences using Cochran-Mantel-Haenszel weighting.~Non-response imputation was used for participants with missing HiSCR100."||||0.3322
72470379|NCT00790205|144465138|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.69|||<|0.001|TWO_SIDED|95.0|0.61|0.77|||Cox proportional hazards model|Model stratified by region with treatment group only as explanatory variable.||||0.77|0.61|<0.001
72470380|NCT00790205|144465139|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.7|||<|0.001|TWO_SIDED|95.0|0.63|0.79|||Cox proportional hazards model|Model stratified by region with treatment group only as explanatory variable.||||0.79|0.63|<0.001
72470381|NCT00790205|144465140|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.7|||<|0.001|TWO_SIDED|95.0|0.65|0.75|||Cox proportional hazards model|Model stratified by region with treatment group only as explanatory variable.||||0.75|0.65|<0.001
72470382|NCT00790205|144465141|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.72|||<|0.001|TWO_SIDED|95.0|0.68|0.77|||Cox proportional hazards model|Model stratified by region with treatment group only as explanatory variable.||||0.77|0.68|<0.001
72470383|NCT04937920|144465147|OTHER||Mean Paired Change from Baseline|-29620.0||||0.2|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||The analysis compared the differences at Day 5 between DBI-002 probiotic gel (active) and vehicle gel (active Cohort 4 only) in abundance of Malassezia based on molecular diagnostic qPCR using a 2-sided Wilcoxon sign rank test, alpha = 0.05, with a null hypothesis of median difference equal to zero.||||0.2
72470384|NCT04937920|144465147|OTHER||Mean Paired Change from Baseline|127195.0||||1|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||The analysis compared the differences at Day 14 between DBI-002 probiotic gel (active) and vehicle gel (active Cohort 4 only) in abundance of Malassezia based on molecular diagnostic qPCR using a 2-sided Wilcoxon sign rank test, alpha = 0.05, with a null hypothesis of median difference equal to zero.||||1.0
72470385|NCT04937920|144465147|OTHER||Mean Paired Change from Baseline|-41659.0||||0.6|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||The analysis compared the differences at Day 5 between aqueous gel (control) and vehicle gel (active Cohort 4 only) in abundance of Malassezia based on molecular diagnostic qPCR using a 2-sided Wilcoxon sign rank test, alpha = 0.05, with a null hypothesis of median difference equal to zero.||||0.6
72470386|NCT04937920|144465147|OTHER||Mean Paired Change from Baseline|-483.0||||1|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||The analysis compared the differences at Day 14 between aqueous gel (control) and vehicle gel (active Cohort 4 only) in abundance of Malassezia based on molecular diagnostic qPCR using a 2-sided Wilcoxon sign rank test, alpha = 0.05, with a null hypothesis of median difference equal to zero.||||1.0
72470387|NCT04092452|144465168|SUPERIORITY||Risk Difference (RD)|0.7|STANDARD_ERROR_OF_MEAN|9.69||0.4696|TWO_SIDED|90.0|-15.2|16.7||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||The null hypothesis for primary efficacy analysis was that the percentage of participants achieving HiSCR response at Week 16 was the same for the active treatment (PF-06650833, PF-06700841 or PF-06826647) and placebo. The treatment was considered superior to control if the difference was statistically significant at the overall 1-sided 0.1 level.||16.7|-15.2|0.4696
72470388|NCT04092452|144465168|SUPERIORITY||Risk Difference (RD)|18.7|STANDARD_ERROR_OF_MEAN|9.71||0.0298|TWO_SIDED|90.0|2.7|34.6||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||The null hypothesis for primary efficacy analysis was that the percentage of participants achieving HiSCR response at Week 16 was the same for the active treatment (PF-06650833, PF-06700841 or PF-06826647) and placebo. The treatment was considered superior to control if the difference was statistically significant at the overall 1-sided 0.1 level.||34.6|2.7|0.0298
72470389|NCT04092452|144465168|SUPERIORITY||Risk Difference (RD)|3.5|STANDARD_ERROR_OF_MEAN|9.79||0.3606|TWO_SIDED|90.0|-12.6|19.6||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||The null hypothesis for primary efficacy analysis was that the percentage of participants achieving HiSCR response at Week 16 was the same for the active treatment (PF-06650833, PF-06700841 or PF-06826647) and placebo. The treatment was considered superior to control if the difference was statistically significant at the overall 1-sided 0.1 level.||19.6|-12.6|0.3606
72470390|NCT04092452|144465169|SUPERIORITY||Risk Difference (RD)|-3.8|STANDARD_ERROR_OF_MEAN|7.19|||TWO_SIDED|90.0|-15.6|8.0||||||Week 1||8.0|-15.6|
72470391|NCT04092452|144465169|SUPERIORITY||Risk Difference (RD)|-0.9|STANDARD_ERROR_OF_MEAN|7.28|||TWO_SIDED|90.0|-12.9|11.1||||||Week 1||11.1|-12.9|
72470392|NCT04092452|144465169|SUPERIORITY||Risk Difference (RD)|4.6|STANDARD_ERROR_OF_MEAN|7.99|||TWO_SIDED|90.0|-8.5|17.8||||||Week 1||17.8|-8.5|
72470393|NCT04092452|144465169|SUPERIORITY||Risk Difference (RD)|7.9|STANDARD_ERROR_OF_MEAN|9.02|||TWO_SIDED|90.0|-6.9|22.8||||||Week 2||22.8|-6.9|
72470394|NCT04092452|144465169|SUPERIORITY||Risk Difference (RD)|7.5|STANDARD_ERROR_OF_MEAN|8.91|||TWO_SIDED|90.0|-7.1|22.2||||||Week 2||22.2|-7.1|
72505071|NCT01380093|144541440|SUPERIORITY_OR_OTHER||LS Mean Difference|-116.1|||<|0.0001|TWO_SIDED|95.0|-136.5|-95.7|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-95.7|-136.5|<0.0001
72505072|NCT01380093|144541440|SUPERIORITY_OR_OTHER||LS Mean Difference|59.7|||<|0.0001|TWO_SIDED|95.0|39.3|80.1|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||80.1|39.3|<0.0001
72505073|NCT01380093|144541440|SUPERIORITY_OR_OTHER||LS Mean Difference|175.8|||<|0.0001|TWO_SIDED|95.0|155.4|196.2|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||196.2|155.4|<0.0001
72470395|NCT04092452|144465169|SUPERIORITY||Risk Difference (RD)|3.5|STANDARD_ERROR_OF_MEAN|9.0|||TWO_SIDED|90.0|-11.3|18.3||||||Week 2||18.3|-11.3|
72470396|NCT04092452|144465169|SUPERIORITY||Risk Difference (RD)|9.0|STANDARD_ERROR_OF_MEAN|9.79|||TWO_SIDED|90.0|-7.1|25.1||||||Week 4||25.1|-7.1|
72470397|NCT04092452|144465169|SUPERIORITY||Risk Difference (RD)|7.7|STANDARD_ERROR_OF_MEAN|9.57|||TWO_SIDED|90.0|-8.0|23.5||||||Week 4||23.5|-8.0|
72470398|NCT04092452|144465169|SUPERIORITY||Risk Difference (RD)|-4.0|STANDARD_ERROR_OF_MEAN|9.37|||TWO_SIDED|90.0|-19.4|11.4||||||Week 4||11.4|-19.4|
72505074|NCT01380093|144541441|SUPERIORITY_OR_OTHER||LS Mean Difference|-202.2|||<|0.0001|TWO_SIDED|95.0|-239.0|-165.3|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-165.3|-239.0|<0.0001
72505075|NCT01380093|144541441|SUPERIORITY_OR_OTHER||LS Mean Difference|122.5|||<|0.0001|TWO_SIDED|95.0|85.7|159.2|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||159.2|85.7|<0.0001
72505076|NCT01380093|144541441|SUPERIORITY_OR_OTHER||LS Mean Difference|324.6|||<|0.0001|TWO_SIDED|95.0|287.7|361.5|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||361.5|287.7|<0.0001
72505077|NCT01380093|144541442|SUPERIORITY_OR_OTHER||LS Mean Difference|-253.0|||<|0.0001|TWO_SIDED|95.0|-301.5|-204.5|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-204.5|-301.5|<0.0001
72470399|NCT04092452|144465169|SUPERIORITY||Risk Difference (RD)|0.8|STANDARD_ERROR_OF_MEAN|9.96|||TWO_SIDED|90.0|-15.6|17.2||||||Week 6||17.2|-15.6|
72470400|NCT04092452|144465169|SUPERIORITY||Risk Difference (RD)|6.7|STANDARD_ERROR_OF_MEAN|9.81|||TWO_SIDED|90.0|-9.4|22.9||||||Week 6||22.9|-9.4|
72470401|NCT04092452|144465169|SUPERIORITY||Risk Difference (RD)|3.7|STANDARD_ERROR_OF_MEAN|10.05|||TWO_SIDED|90.0|-12.8|20.2||||||Week 6||20.2|-12.8|
72470402|NCT04092452|144465169|SUPERIORITY||Risk Difference (RD)|-7.8|STANDARD_ERROR_OF_MEAN|9.98||0.7798|TWO_SIDED|90.0|-24.2|8.7||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 8||8.7|-24.2|0.7798
72470403|NCT04092452|144465169|SUPERIORITY||Risk Difference (RD)|0.5|STANDARD_ERROR_OF_MEAN|9.92||0.4819|TWO_SIDED|90.0|-15.9|16.8||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 8||16.8|-15.9|0.4819
72470404|NCT04092452|144465169|SUPERIORITY||Risk Difference (RD)|-2.4|STANDARD_ERROR_OF_MEAN|10.19||0.5933|TWO_SIDED|90.0|-19.2|14.4||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 8||14.4|-19.2|0.5933
72395203|NCT05355805|144297056|SUPERIORITY||Risk Difference (RD)|8.63|STANDARD_ERROR_OF_MEAN|8.78||0.3258|TWO_SIDED|||||The estimated risk difference divided by the standard error was used as the test statistic and a p-value calculated assuming that the test statistic follows a standard normal distribution under the null hypothesis.|Cochran-Mantel-Haenszel|||"The common risk difference between placebo QW/Q2W and the izokibep 160 mg QW arm among the four strata, prior biologic/JAK inhibitor use for HS (Yes/No) and Hurley Stage (II or III), used for randomization and associated standard error will be estimated by combining the observed risk differences using Cochran-Mantel-Haenszel weighting.~Non-response imputation was used for participants with missing HiSCR50."||||0.3258
72395204|NCT05355805|144297056|SUPERIORITY||Risk Difference (RD)|7.28|STANDARD_ERROR_OF_MEAN|8.775||0.4068|TWO_SIDED|||||The estimated risk difference divided by the standard error was used as the test statistic and a p-value calculated assuming that the test statistic follows a standard normal distribution under the null hypothesis.|Cochran-Mantel-Haenszel|||"The common risk difference between placebo QW/Q2W and the izokibep 160 mg Q2W arm among the four strata, prior biologic/JAK inhibitor use for HS (Yes/No) and Hurley Stage (II or III), used for randomization and associated standard error will be estimated by combining the observed risk differences using Cochran-Mantel-Haenszel weighting.~Non-response imputation was used for participants with missing HiSCR50."||||0.4068
72395205|NCT05355805|144297057|SUPERIORITY|Predictors in the regression model for missing values at Week 16 are Baseline Hurley stage, baseline abscess count, baseline inflammatory nodule count, baseline draining fistula count, sex, race, age, BMI and Prior Biologic/JAK inhibitor use for HS plus counts of abscess, inflammatory nodule, and draining fistula at prior scheduled assessment. Missing flare values in both the placebo and izokibep groups are imputed using observed data from the placebo group only.|Risk Difference (RD)|-7.4|STANDARD_ERROR_OF_MEAN|7.661||0.3329|TWO_SIDED|||||The estimated risk difference divided by the standard error will be used as the test statistic and a p-value calculated assuming that the test statistic follows a standard normal distribution under the null hypothesis.|Cochran-Mantel-Haenszel|||"The common risk difference between placebo QW/Q2W and the izokibep 160 mg QW arm among the four strata, prior biologic/JAK inhibitor use for HS (Yes/No) and Hurley Stage (II or III), used for randomization and associated standard error will be estimated by combining the observed risk differences using Cochran-Mantel-Haenszel weighting.~Missing data of abscess and inflammatory nodules counts at scheduled visits are imputed assuming monotone missingness pattern."||||0.3329
72395206|NCT05355805|144297057|SUPERIORITY|Predictors in the regression model for missing values at Week 16 are Baseline Hurley stage, baseline abscess count, baseline inflammatory nodule count, baseline draining fistula count, sex, race, age, BMI and Prior Biologic/JAK inhibitor use for HS plus counts of abscess, inflammatory nodule, and draining fistula at prior scheduled assessment. Missing flare values in both the placebo and izokibep groups are imputed using observed data from the placebo group only.|Risk Difference (RD)|4.06|STANDARD_ERROR_OF_MEAN|7.574||0.5882|TWO_SIDED|||||The estimated risk difference divided by the standard error was used as the test statistic and a p-value calculated assuming that the test statistic follows a standard normal distribution under the null hypothesis.|Cochran-Mantel-Haenszel|||"The common risk difference between placebo QW/Q2W and the izokibep 160 mg Q2W arm among the four strata, prior biologic/JAK inhibitor use for HS (Yes/No) and Hurley Stage (II or III), used for randomization and associated standard error will be estimated by combining the observed risk differences using Cochran-Mantel-Haenszel weighting.~Missing data of abscess and inflammatory nodules counts at scheduled visits are imputed assuming monotone missingness pattern."||||0.5882
72395207|NCT05355805|144297058|SUPERIORITY||Risk Difference (RD)|7.31|STANDARD_ERROR_OF_MEAN|11.995||0.5422|TWO_SIDED|||||The estimated risk difference divided by the standard error was used as the test statistic and a p-value calculated assuming that the test statistic follows a standard normal distribution under the null hypothesis.|Cochran-Mantel-Haenszel|||The common risk difference between placebo QW/Q2W and the izokibep 160 mg QW arm among the four strata, prior biologic/JAK inhibitor use for HS (Yes/No), used for randomization and associated standard error will be estimated by combining the observed risk differences using Cochran-Mantel-Haenszel weighting.||||0.5422
72470405|NCT04092452|144465169|SUPERIORITY||Risk Difference (RD)|-9.9|STANDARD_ERROR_OF_MEAN|9.81||0.8421|TWO_SIDED|90.0|-26.1|6.2||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 12||6.2|-26.1|0.8421
72470406|NCT04092452|144465169|SUPERIORITY||Risk Difference (RD)|8.0|STANDARD_ERROR_OF_MEAN|9.85||0.209|TWO_SIDED|90.0|-8.2|24.2||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 12||24.2|-8.2|0.2090
72470407|NCT04092452|144465169|SUPERIORITY||Risk Difference (RD)|-0.5|STANDARD_ERROR_OF_MEAN|10.12||0.5183|TWO_SIDED|90.0|-17.1|16.2||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 12||16.2|-17.1|0.5183
72470408|NCT04092452|144465170|SUPERIORITY||Risk Difference (RD)|-0.3|STANDARD_ERROR_OF_MEAN|7.54||0.515|TWO_SIDED|90.0|-12.7|12.1||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Total AN Count of 0 or 1||12.1|-12.7|0.5150
72470409|NCT04092452|144465170|SUPERIORITY||Risk Difference (RD)|12.2|STANDARD_ERROR_OF_MEAN|8.28||0.0737|TWO_SIDED|90.0|-1.4|25.8||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Total AN Count of 0 or 1||25.8|-1.4|0.0737
72470410|NCT04092452|144465170|SUPERIORITY||Risk Difference (RD)|6.6|STANDARD_ERROR_OF_MEAN|8.11||0.2081|TWO_SIDED|90.0|-6.7|20.0||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Total AN Count of 0 or 1||20.0|-6.7|0.2081
72470411|NCT04092452|144465170|SUPERIORITY||Risk Difference (RD)|4.8|STANDARD_ERROR_OF_MEAN|8.9||0.2957|TWO_SIDED|90.0|-9.9|19.4||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Total AN Count of 0, 1 or 2||19.4|-9.9|0.2957
72470412|NCT04092452|144465170|SUPERIORITY||Risk Difference (RD)|15.6|STANDARD_ERROR_OF_MEAN|9.07||0.0456|TWO_SIDED|90.0|0.7|30.5||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Total AN Count of 0, 1 or 2||30.5|0.7|0.0456
72622507|NCT01339091|144775036|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority hypothesis test is a one-sided hypothesis test performed at the 2.5% level of significance. If the lower limit of the 95% CI for the difference in response rates in the ITT population is greater than -10% the NI of dalbavancin to vancomycin/linezolid will be concluded.|Difference in Proportions|1.5|||||TWO_SIDED|95.0|-4.6|7.9|||||Confidence intervals were adjusted for fever at baseline|||7.9|-4.6|
72622508|NCT01149460|144775054|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of Least Squares Means (T/R)|111.34|||||TWO_SIDED|90.0|100.54|123.29|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the test (T) and reference (R) product fall within the interval of 80-125%.|||123.29|100.54|
72622509|NCT01149460|144775055|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of Least Squares Means (T/R)|100.01|||||TWO_SIDED|90.0|96.34|103.82|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the test (T) and reference (R) product fall within the interval of 80-125%.|||103.82|96.34|
72622510|NCT01149460|144775056|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of Least Squares Means (T/R)|100.01|||||TWO_SIDED|90.0|96.38|103.78|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the test (T) and reference (R) product fall within the interval of 80-125%.|||103.78|96.38|
72622511|NCT01149460|144775057|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of Least Squares Means (T/R)|103.48|||||TWO_SIDED|90.0|97.87|109.41|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the test (T) and reference (R) product fall within the interval of 80-125%.|||109.41|97.87|
72622512|NCT01149460|144775058|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of Least Squares Means (T/R)|99.2|||||TWO_SIDED|90.0|97.14|101.31|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the test (T) and reference (R) product fall within the interval of 80-125%.|||101.31|97.14|
72622513|NCT01149460|144775059|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of Least Squares Means|99.1|||||TWO_SIDED|90.0|97.04|101.19|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the test (T) and reference (R) product fall within the interval of 80-125%.|||101.19|97.04|
72395208|NCT05355805|144297058|SUPERIORITY||Risk Difference (RD)|-5.23|STANDARD_ERROR_OF_MEAN|11.77||0.6569|TWO_SIDED|||||The estimated risk difference divided by the standard error was used as the test statistic and a p-value calculated assuming that the test statistic follows a standard normal distribution under the null hypothesis.|Cochran-Mantel-Haenszel|||The common risk difference between placebo QW/Q2W and the izokibep 160 mg Q2W arm among the four strata, prior biologic/JAK inhibitor use for HS (Yes/No), used for randomization and associated standard error will be estimated by combining the observed risk differences using Cochran-Mantel-Haenszel weighting.||||0.6569
72622514|NCT00839930|144775064|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of Variance (ANOVA) will be performed on the log-transformed AUC0-t, AUC0-inf and Cmax parameters.|Geometric Test/Ref Ratio x 100|93.39||||||90.0|87.33|99.86|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||99.86|87.33|
72622515|NCT00839930|144775065|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of Variance (ANOVA) will be performed on the log-transformed AUC0-t, AUC0-inf and Cmax parameters.|Geometric Test/Ref Ratio x 100|96.14||||||90.0|91.04|101.52|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||101.52|91.04|
72622516|NCT00839930|144775066|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of Variance (ANOVA) will be performed on log-transformed AUC0-t, AUC0-inf and Cmax parameters.|Geometric Test/Ref Ratio x 100|96.64||||||90.0|92.13|101.37|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||101.37|92.13|
72505078|NCT01380093|144541442|SUPERIORITY_OR_OTHER||LS Mean Difference|151.9|||<|0.0001|TWO_SIDED|95.0|103.5|200.2|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||200.2|103.5|<0.0001
72622517|NCT02500836|144775067|SUPERIORITY||||||<|0.0001||||||One-sided p-value|Fisher Exact|||The null hypothesis is that the proportions of treatment group successes are equal.||||<0.0001
72622518|NCT02500836|144775068|SUPERIORITY||||||<|0.0001||||||One-sided p-value|Fisher Exact|||The null hypothesis is that the proportions of treatment group successes are equal.||||<0.0001
72622519|NCT02272985|144775071|OTHER||||||=|0.03||||||the p value was calculated|Mixed Models Analysis|||||||=0.03
72622520|NCT02272985|144775072|OTHER|||||||0.001|||||||Mixed Models Analysis|||Left frontal gray matter:||||0.001
72622521|NCT02272985|144775072|OTHER|||||||0.08|||||||Mixed Models Analysis|||Right frontal gray matter:||||0.08
72622522|NCT00266032|144775073|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-25.0|STANDARD_DEVIATION|29.0|<|0.0001||95.0|-29.0|-20.0|||t-test, 2 sided||Mean of Yaz flexible regimen minus mean of Yaz standard was tested|Primary variable was tested for the hypothesis, whether the means are equal against the alternative (means are different) at a level of significance of alpha = 0.05 (t-test). For power calculation, a normal distribution, a absolute difference of 10 days, a Standard Deviation of 28 days and a drop-out rate of 40% was assumed.||-20|-29|<0.0001
72622523|NCT01220687|144775106|SUPERIORITY||Mean Difference (Final Values)|9.0||||0.0012|TWO_SIDED||||||t-test, 2 sided|||||||0.0012
72470413|NCT04092452|144465170|SUPERIORITY||Risk Difference (RD)|9.2|STANDARD_ERROR_OF_MEAN|9.05||0.1558|TWO_SIDED|90.0|-5.7|24.1||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Total AN Count of 0, 1 or 2||24.1|-5.7|0.1558
72470414|NCT04092452|144465171|SUPERIORITY||Risk Difference (RD)|-11.98|STANDARD_ERROR_OF_MEAN|8.622|||TWO_SIDED|90.0|-26.16|2.2||||||Week 1||2.20|-26.16|
72470415|NCT04092452|144465171|SUPERIORITY||Risk Difference (RD)|-15.07|STANDARD_ERROR_OF_MEAN|8.526|||TWO_SIDED|90.0|-29.09|-1.04||||||Week 1||-1.04|-29.09|
72470416|NCT04092452|144465171|SUPERIORITY||Risk Difference (RD)|-17.45|STANDARD_ERROR_OF_MEAN|8.758|||TWO_SIDED|90.0|-31.86|-3.05||||||Week 1||-3.05|-31.86|
72470417|NCT04092452|144465171|SUPERIORITY||Risk Difference (RD)|-12.52|STANDARD_ERROR_OF_MEAN|9.465|||TWO_SIDED|90.0|-28.09|3.05||||||Week 2||3.05|-28.09|
72470418|NCT04092452|144465171|SUPERIORITY||Risk Difference (RD)|-2.86|STANDARD_ERROR_OF_MEAN|9.338|||TWO_SIDED|90.0|-18.22|12.5||||||Week 2||12.50|-18.22|
72505079|NCT01380093|144541442|SUPERIORITY_OR_OTHER||LS Mean Difference|404.9|||<|0.0001|TWO_SIDED|95.0|356.4|453.3|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||453.3|356.4|<0.0001
72505080|NCT01380093|144541443|SUPERIORITY_OR_OTHER||LS Mean Difference|-306.8|||<|0.0001|TWO_SIDED|95.0|-370.9|-242.6|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-242.6|-370.9|<0.0001
72505081|NCT01380093|144541443|SUPERIORITY_OR_OTHER||LS Mean Difference|168.6|||<|0.0001|TWO_SIDED|95.0|104.7|232.6|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||232.6|104.7|<0.0001
72505082|NCT01380093|144541443|SUPERIORITY_OR_OTHER||LS Mean Difference|475.4|||<|0.0001|TWO_SIDED|95.0|411.3|539.6|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||539.6|411.3|<0.0001
72505083|NCT01380093|144541444|SUPERIORITY_OR_OTHER||LS Mean Difference|0.2||||0.5607|TWO_SIDED|95.0|-0.6|1.0|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||1.0|-0.6|0.5607
72505084|NCT01380093|144541444|SUPERIORITY_OR_OTHER||LS Mean Difference|2.0|||<|0.0001|TWO_SIDED|95.0|1.2|2.8|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||2.8|1.2|<0.0001
72505085|NCT01380093|144541444|SUPERIORITY_OR_OTHER||LS Mean Difference|1.8|||<|0.0001|TWO_SIDED|95.0|1.0|2.6|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||2.6|1.0|<0.0001
72470419|NCT04092452|144465171|SUPERIORITY||Risk Difference (RD)|-5.5|STANDARD_ERROR_OF_MEAN|9.438|||TWO_SIDED|90.0|-21.02|10.03||||||Week 2||10.03|-21.02|
72470420|NCT04092452|144465171|SUPERIORITY||Risk Difference (RD)|-4.52|STANDARD_ERROR_OF_MEAN|11.214|||TWO_SIDED|90.0|-22.96|13.93||||||Week 4||13.93|-22.96|
72470421|NCT04092452|144465171|SUPERIORITY||Risk Difference (RD)|-17.54|STANDARD_ERROR_OF_MEAN|11.131|||TWO_SIDED|90.0|-35.84|0.77||||||Week 4||0.77|-35.84|
72470422|NCT04092452|144465171|SUPERIORITY||Risk Difference (RD)|-3.92|STANDARD_ERROR_OF_MEAN|11.507|||TWO_SIDED|90.0|-22.85|15.0||||||Week 4||15.00|-22.85|
72470423|NCT04092452|144465171|SUPERIORITY||Risk Difference (RD)|7.09|STANDARD_ERROR_OF_MEAN|13.452|||TWO_SIDED|90.0|-15.04|29.22||||||Week 6||29.22|-15.04|
72470424|NCT04092452|144465171|SUPERIORITY||Risk Difference (RD)|-14.57|STANDARD_ERROR_OF_MEAN|13.688|||TWO_SIDED|90.0|-37.08|7.95||||||Week 6||7.95|-37.08|
72470425|NCT04092452|144465171|SUPERIORITY||Risk Difference (RD)|-8.95|STANDARD_ERROR_OF_MEAN|13.808|||TWO_SIDED|90.0|-31.66|13.76||||||Week 6||13.76|-31.66|
72470426|NCT04092452|144465171|SUPERIORITY||Risk Difference (RD)|11.5|STANDARD_ERROR_OF_MEAN|13.057||0.8108|TWO_SIDED|90.0|-9.98|32.98||One-sided p-value|ANCOVA|||Week 8||32.98|-9.98|0.8108
72470427|NCT04092452|144465171|SUPERIORITY||Risk Difference (RD)|-16.15|STANDARD_ERROR_OF_MEAN|12.845||0.1043|TWO_SIDED|90.0|-37.28|4.98||One-sided p-value|ANCOVA|||Week 8||4.98|-37.28|0.1043
72470428|NCT04092452|144465171|SUPERIORITY||Risk Difference (RD)|-15.07|STANDARD_ERROR_OF_MEAN|13.355||0.1296|TWO_SIDED|90.0|-37.04|6.9||One-sided p-value|ANCOVA|||Week 8||6.90|-37.04|0.1296
72470429|NCT04092452|144465171|SUPERIORITY||Risk Difference (RD)|-6.54|STANDARD_ERROR_OF_MEAN|16.384||0.345|TWO_SIDED|90.0|-33.49|20.42||One-sided p-value|ANCOVA|||Week 12||20.42|-33.49|0.3450
72470430|NCT04092452|144465171|SUPERIORITY||Risk Difference (RD)|-17.18|STANDARD_ERROR_OF_MEAN|14.116||0.1119|TWO_SIDED|90.0|-40.4|6.04||One-sided p-value|ANCOVA|||Week 12||6.04|-40.40|0.1119
72470431|NCT04092452|144465171|SUPERIORITY||Risk Difference (RD)|-19.99|STANDARD_ERROR_OF_MEAN|14.806||0.0885|TWO_SIDED|90.0|-44.34|4.37||One-sided p-value|ANCOVA|||Week 12||4.37|-44.34|0.0885
72470432|NCT04092452|144465171|SUPERIORITY||Risk Difference (RD)|10.85|STANDARD_ERROR_OF_MEAN|20.14||0.705|TWO_SIDED|90.0|-22.28|43.98||One-sided p-value|ANCOVA|||Week 16||43.98|-22.28|0.7050
72470433|NCT04092452|144465171|SUPERIORITY||Risk Difference (RD)|-17.62|STANDARD_ERROR_OF_MEAN|19.519||0.1833|TWO_SIDED|90.0|-49.73|14.48||One-sided p-value|ANCOVA|||Week 16||14.48|-49.73|0.1833
72470434|NCT04092452|144465171|SUPERIORITY||Risk Difference (RD)|-9.41|STANDARD_ERROR_OF_MEAN|20.277||0.3213|TWO_SIDED|90.0|-42.76|23.94||One-sided p-value|ANCOVA|||Week 16||23.94|-42.76|0.3213
72622524|NCT01220687|144775107|SUPERIORITY||Rate Ratio|1.91|||<|0.0001|TWO_SIDED|95.0|1.68|2.18|||Poisson|||||2.18|1.68|<0.0001
72565324|NCT01833533|144662099|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The noninferiority of the rate of sustained virologic response at 12 weeks after treatment for the ABT-450/r/ABT-267 and ABT-333, plus placebo RBV treatment group as compared with the historical rate for telaprevir plus pegIFN-RBV was analyzed; the lower confidence bound of the 2-sided 95% confidence interval (95% CI) for the percentage of participants with sustained virologic response at 12 weeks after treatment must exceed 65% to achieve noninferiority.|Percentage of Participants|90.2|||||TWO_SIDED|95.0|86.2|94.3|||||95% CI was calculated using the normal approximation to the binomial distribution.|Based on a 2-sided significance level of 0.05 and an underlying rate of ≥90% in the ABT-450/r/ABT-267 and ABT-333, plus RBV arm (100 participants) and ≥85% in the ABT-450/r/ABT-267 and ABT-333, plus Placebo RBV arm (200 participants) provides \>95% power to demonstrate noninferiority of each regimen to the historical rate for telaprevir plus pegIFN and RBV therapy (75%) (based on the normal approximation of a single binomial proportion in a one-sample test for superiority).||94.3|86.2|
72565325|NCT01833533|144662099|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The noninferiority of the rate of sustained virologic response at 12 weeks for the ABT-450/r/ABT-267 and ABT-333, plus RBV treatment group as compared with the historical rate for telaprevir plus pegIFN-RBV was analyzed; the lower confidence bound of the 2-sided 95% CI for the percentage of participants with sustained virologic response at 12 weeks after treatment must exceed 65% to achieve noninferiority.|Percentage of Participants|97.0|||||TWO_SIDED|95.0|93.7|100.0|||||95% CI was calculated using the normal approximation to the binomial distribution.|Based on a 2-sided significance level of 0.05 and an underlying rate of ≥90% in the ABT-450/r/ABT-267 and ABT-333, plus RBV arm (100 participants) and ≥85% in the ABT-450/r/ABT-267 and ABT-333, plus Placebo RBV arm (200 participants) provides \>95% power to demonstrate noninferiority of each regimen to the historical rate for telaprevir plus pegIFN and RBV therapy (75%) (based on the normal approximation of a single binomial proportion in a one-sample test for superiority).||100.0|93.7|
72565326|NCT01833533|144662100|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Fisher Exact|||||||<0.001
72565327|NCT01833533|144662101|SUPERIORITY_OR_OTHER_LEGACY||Percentage of Participants|97.0|||||TWO_SIDED|95.0|93.7|100.0|||||95% CI was calculated using the normal approximation to the binomial distribution; the lower confidence bound for the percentage of participants with sustained virologic response at 12 weeks after treatment must exceed 75% to achieve superiority.|Based on a 2-sided significance level of 0.05 and an underlying rate of ≥90% in the ABT-450/r/ABT-267 and ABT-333, plus RBV arm (100 participants) and ≥85% in the ABT-450/r/ABT-267 and ABT-333, plus Placebo RBV arm (200 participants) provides \>90% power to demonstrate superiority of each regimen to the historical rate for telaprevir plus pegIFN and RBV therapy (75%) (based on the normal approximation of a single binomial proportion in a one-sample test for superiority).||100.0|93.7|
72565328|NCT01833533|144662101|SUPERIORITY_OR_OTHER_LEGACY||Percentage of Participants|90.2|||||TWO_SIDED|95.0|86.2|94.3|||||95% CI was calculated using the normal approximation to the binomial distribution; the lower confidence bound for the percentage of participants with sustained virologic response at 12 weeks after treatment must exceed 75% to achieve superiority.|Based on a 2-sided significance level of 0.05 and an underlying rate of ≥90% in the ABT-450/r/ABT-267 and ABT-333, plus RBV arm (100 participants) and ≥85% in the ABT-450/r/ABT-267 and ABT-333, plus Placebo RBV arm (200 participants) provides \>90% power to demonstrate superiority of each regimen to the historical rate for telaprevir plus pegIFN and RBV therapy (75%) (based on the normal approximation of a single binomial proportion in a one-sample test for superiority).||94.3|86.2|
72565329|NCT01833533|144662101|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Noninferiority of the rate of sustained virologic response at 12 weeks after treatment in the ABT-450/r/ABT-267 and ABT-333, plus placebo RBV treatment group as compared with the ABT-450/r/ABT-267 and ABT-333, plus RBV treatment group was analyzed using a noninferiority margin of -10.5%; the lower confidence bound of the 2-sided 95% CI (calculated using normal approximation to the binomial distribution)for the difference in percentage of participants must exceed -10.5% to achieve noninferiority.|Difference in Percentage of Participants|-6.8|||||TWO_SIDED|95.0|-12.0|-1.5|||||95% CI was calculated using the normal approximation to the binomial distribution.|Based on a 2-sided significance level of 0.05 and an underlying rate of ≥90% in the ABT-450/r/ABT-267 and ABT-333, plus RBV arm (100 participants) and ≥85% in the ABT-450/r/ABT-267 and ABT-333, plus Placebo RBV arm (200 participants) provides \>95% power to demonstrate noninferiority of the ABT-450/r/ABT-267 and ABT-333, plus RBV arm compared with the ABT-450/r/ABT-267 and ABT-333, plus Placebo RBV arm (normal approximation of a single binomial proportion in a one-sample test for superiority).||-1.5|-12.0|
72622525|NCT03715829|144775122|SUPERIORITY||Least Squares Mean Difference (Net)|-23.2|STANDARD_ERROR_OF_MEAN|5.62|<|0.0001|TWO_SIDED|90.0|-32.53|-13.96||Hochberg's step-up procedure was conducted to compare ritlecitinib 200mg - 50mg QD dose group vs placebo using observed p-values. The familywise Type 1 error rate was controlled at one-sided 0.05. Hochberg adjusted p-value is presented here.|ANCOVA|||||-13.96|-32.53|<0.0001
72470435|NCT04092452|144465172|SUPERIORITY||Risk Difference (RD)|-1.5|STANDARD_ERROR_OF_MEAN|2.67|||TWO_SIDED|90.0|-5.9|2.9||||||Week 1 - Statistical Analysis (MI) - Absolute Score||2.9|-5.9|
72565330|NCT01138826|144662106|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Natural log transformed AUC\[0- ∞\] of amlodipine was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.|Adjusted ratio of geometric means|105.57|||||TWO_SIDED|90.0|98.09|113.61||||||A sample size of 12 completers provided 90% confidence intervals for the difference between treatment of +/-0.1036 on the natural log scale for AUCinf with 90% coverage probability. These calculations were based on estimates of within-participant standard deviations of 0.1234 for loge AUCinf.||113.61|98.09|
72576656|NCT01635218|144680103|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.2|STANDARD_ERROR_OF_MEAN|0.81|<|0.05|TWO_SIDED|95.0|1.31|5.25||The ANOVA result (p\<0.05)suggests rejecting the global null hypothesis.Bonferroni post-hoc test was used to determine which means differ among groups.|ANOVA|||||5.25|1.31|<0.05
72576657|NCT01635218|144680104|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.4|STANDARD_ERROR_OF_MEAN|1.71||0.14|TWO_SIDED|95.0|-0.73|7.61||The statistical significant ANOVA result (p\<0.05) suggests rejecting the global null hypothesis.Bonferroni post-hoc test was used to determine which means differ among groups.|ANOVA|||||7.61|-0.73|0.14
72565331|NCT01138826|144662106|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Natural log transformed AUC\[0- ∞\] of amlodipine was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.|Adjusted ratio of geometric means|107.55|||||TWO_SIDED|90.0|99.98|115.69||||||A sample size of 12 completers provided 90% confidence intervals for the difference between treatment of +/-0.1036 on the natural log scale for AUCinf with 90% coverage probability. These calculations were based on estimates of within-participant standard deviations of 0.1234 for loge AUCinf.||115.69|99.98|
72565332|NCT01138826|144662106|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Natural log transformed AUC\[0- ∞\] of amlodipine was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.|Adjusted ratio of geometric means|101.88|||||TWO_SIDED|90.0|94.7|109.6||||||A sample size of 12 completers provided 90% confidence intervals for the difference between treatment of +/-0.1036 on the natural log scale for AUCinf with 90% coverage probability. These calculations were based on estimates of within-participant standard deviations of 0.1234 for loge AUCinf.||109.60|94.70|
72565333|NCT01138826|144662107|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Natural log transformed AUClast of amlodipine was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.|Adjusted ratio of geometric means|103.88|||||TWO_SIDED|90.0|97.27|110.94||||||||110.94|97.27|
72565334|NCT01138826|144662107|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Natural log transformed AUClast of amlodipine was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.|Adjusted ratio of geometric means|104.26|||||TWO_SIDED|90.0|97.67|111.3||||||||111.30|97.67|
72565335|NCT01138826|144662107|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Natural log transformed AUClast of amlodipine was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.|Adjusted ratio of geometric means|100.37|||||TWO_SIDED|90.0|94.02|107.15||||||||107.15|94.02|
72565336|NCT01138826|144662108|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Natural log transformed Cmax of amlodipine was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.|Adjusted ratio of geometric means|98.39|||||TWO_SIDED|90.0|91.05|106.33||||||A sample size of 12 completers provided 90% confidence intervals for the difference between treatment of +/-0.1146 on the natural log scale for Cmax with 90% coverage probability. These calculations were based on estimates of within-participant standard deviations of 0.1366 for loge Cmax.||106.33|91.05|
72622526|NCT03715829|144775122|SUPERIORITY||Least Squares Mean Difference (Net)|-23.2|STANDARD_ERROR_OF_MEAN|5.63|<|0.0001|TWO_SIDED|90.0|-32.53|-13.93||Hochberg's step-up procedure was conducted to compare ritlecitinib 100mg - 50mg QD dose group vs placebo using observed p-values. The familywise Type 1 error rate was controlled at one-sided 0.05. Hochberg adjusted p-value is presented here.|ANCOVA|||||-13.93|-32.53|<0.0001
72622527|NCT03715829|144775122|SUPERIORITY||Least Squares Mean Difference (Net)|-20.6|STANDARD_ERROR_OF_MEAN|5.84||0.0003|TWO_SIDED|90.0|-30.23|-10.93||Hochberg's step-up procedure was conducted to compare the ritlecitinib 50 mg QD dose group vs placebo using observed p-values. The familywise Type 1 error rate was controlled at one-sided 0.05. Hochberg adjusted p-value is presented here.|ANCOVA|||||-10.93|-30.23|0.0003
72470436|NCT04092452|144465172|SUPERIORITY||Risk Difference (RD)|-2.0|STANDARD_ERROR_OF_MEAN|2.6|||TWO_SIDED|90.0|-6.3|2.2||||||Week 1 - Statistical Analysis (MI) - Absolute Score||2.2|-6.3|
72565337|NCT01138826|144662108|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Natural log transformed Cmax of amlodipine was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.|Adjusted ratio of geometric means|95.22|||||TWO_SIDED|90.0|88.16|102.84||||||A sample size of 12 completers provided 90% confidence intervals for the difference between treatment of +/-0.1146 on the natural log scale for Cmax with 90% coverage probability. These calculations were based on estimates of within-participant standard deviations of 0.1366 for loge Cmax.||102.84|88.16|
72565338|NCT01138826|144662108|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Natural log transformed Cmax of amlodipine was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.|Adjusted ratio of geometric means|96.77|||||TWO_SIDED|90.0|89.58|104.54||||||A sample size of 12 completers provided 90% confidence intervals for the difference between treatment of +/-0.1146 on the natural log scale for Cmax with 90% coverage probability. These calculations were based on estimates of within-participant standard deviations of 0.1366 for loge Cmax.||104.54|89.58|
72565339|NCT03360916|144662111|SUPERIORITY||Mean Difference (Net)|2.29|STANDARD_DEVIATION|125.59||0.953|TWO_SIDED||||||t-test, 2 sided|This is within group 3 month change||||||0.9530
72565340|NCT03360916|144662111|SUPERIORITY||Mean Difference (Net)|-11.24|STANDARD_DEVIATION|130.12||0.7908|TWO_SIDED||||||t-test, 2 sided|This is within group 3 month change||||||0.7908
72470437|NCT04092452|144465172|SUPERIORITY||Risk Difference (RD)|-1.5|STANDARD_ERROR_OF_MEAN|2.68|||TWO_SIDED|90.0|-5.9|2.9||||||Week 1 - Statistical Analysis (MI) - Absolute Score||2.9|-5.9|
72470438|NCT04092452|144465172|SUPERIORITY||Risk Difference (RD)|-0.9|STANDARD_ERROR_OF_MEAN|2.59|||TWO_SIDED|90.0|-5.2|3.3||||||Week 2 - Statistical Analysis (MI) - Absolute Score||3.3|-5.2|
72470439|NCT04092452|144465172|SUPERIORITY||Risk Difference (RD)|-0.1|STANDARD_ERROR_OF_MEAN|2.55|||TWO_SIDED|90.0|-4.3|4.1||||||Week 2 - Statistical Analysis (MI) - Absolute Score||4.1|-4.3|
72470440|NCT04092452|144465172|SUPERIORITY||Risk Difference (RD)|0.0|STANDARD_ERROR_OF_MEAN|2.61|||TWO_SIDED|90.0|-4.3|4.3||||||Week 2 - Statistical Analysis (MI) - Absolute Score||4.3|-4.3|
72470441|NCT04092452|144465172|SUPERIORITY||Risk Difference (RD)|-0.3|STANDARD_ERROR_OF_MEAN|2.51|||TWO_SIDED|90.0|-4.5|3.8||||||Week 4 - Statistical Analysis (MI) - Absolute Score||3.8|-4.5|
72470442|NCT04092452|144465172|SUPERIORITY||Risk Difference (RD)|-1.3|STANDARD_ERROR_OF_MEAN|2.48|||TWO_SIDED|90.0|-5.4|2.8||||||Week 4 - Statistical Analysis (MI) - Absolute Score||2.8|-5.4|
72470443|NCT04092452|144465172|SUPERIORITY||Risk Difference (RD)|-4.5|STANDARD_ERROR_OF_MEAN|2.58|||TWO_SIDED|90.0|-8.8|-0.3||||||Week 4 - Statistical Analysis (MI) - Absolute Score||-0.3|-8.8|
72470444|NCT04092452|144465172|SUPERIORITY||Risk Difference (RD)|-1.6|STANDARD_ERROR_OF_MEAN|2.99|||TWO_SIDED|90.0|-6.5|3.3||||||Week 6 - Statistical Analysis (MI) - Absolute Score||3.3|-6.5|
72470445|NCT04092452|144465172|SUPERIORITY||Risk Difference (RD)|-4.7|STANDARD_ERROR_OF_MEAN|2.91|||TWO_SIDED|90.0|-9.5|0.1||||||Week 6 - Statistical Analysis (MI) - Absolute Score||0.1|-9.5|
72470446|NCT04092452|144465172|SUPERIORITY||Risk Difference (RD)|-5.4|STANDARD_ERROR_OF_MEAN|3.08|||TWO_SIDED|90.0|-10.5|-0.4||||||Week 6 - Statistical Analysis (MI) - Absolute Score||-0.4|-10.5|
72470447|NCT04092452|144465172|SUPERIORITY||Risk Difference (RD)|1.0|STANDARD_ERROR_OF_MEAN|2.78||0.6393|TWO_SIDED|90.0|-3.6|5.6||One-sided p-value|ANCOVA|||Week 8 - Statistical Analysis (MI) - Absolute Score||5.6|-3.6|0.6393
72505086|NCT01380093|144541445|SUPERIORITY_OR_OTHER||LS Mean Difference|-15.3|||<|0.0001|TWO_SIDED|95.0|-20.3|-10.3|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-10.3|-20.3|<0.0001
72505087|NCT01380093|144541445|SUPERIORITY_OR_OTHER||LS Mean Difference|11.2|||<|0.0001|TWO_SIDED|95.0|6.3|16.2|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||16.2|6.3|<0.0001
72470448|NCT04092452|144465172|SUPERIORITY||Risk Difference (RD)|0.1|STANDARD_ERROR_OF_MEAN|2.72||0.5178|TWO_SIDED|90.0|-4.4|4.6||One-sided p-value|ANCOVA|||Week 8 - Statistical Analysis (MI) - Absolute Score||4.6|-4.4|0.5178
72505088|NCT01380093|144541445|SUPERIORITY_OR_OTHER||LS Mean Difference|26.5|||<|0.0001|TWO_SIDED|95.0|21.5|31.5|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||31.5|21.5|<0.0001
72505089|NCT01380093|144541446|SUPERIORITY_OR_OTHER||LS Mean Difference|-47.7|||<|0.0001|TWO_SIDED|95.0|-59.5|-35.9|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-35.9|-59.5|<0.0001
72505090|NCT01380093|144541446|SUPERIORITY_OR_OTHER||LS Mean Difference|28.3|||<|0.0001|TWO_SIDED|95.0|16.5|40.1|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||40.1|16.5|<0.0001
72470449|NCT04092452|144465172|SUPERIORITY||Risk Difference (RD)|-3.8|STANDARD_ERROR_OF_MEAN|2.82||0.0864|TWO_SIDED|90.0|-8.5|0.8||One-sided p-value|ANCOVA|||Week 8 - Statistical Analysis (MI) - Absolute Score||0.8|-8.5|0.0864
72470450|NCT04092452|144465172|SUPERIORITY||Risk Difference (RD)|-1.2|STANDARD_ERROR_OF_MEAN|2.61||0.3172|TWO_SIDED|90.0|-5.5|3.1||One-sided p-value|ANCOVA|||Week 12 - Statistical Analysis (MI) - Absolute Score||3.1|-5.5|0.3172
72470451|NCT04092452|144465172|SUPERIORITY||Risk Difference (RD)|-2.7|STANDARD_ERROR_OF_MEAN|2.51||0.1384|TWO_SIDED|90.0|-6.8|1.4||One-sided p-value|ANCOVA|||Week 12 - Statistical Analysis (MI) - Absolute Score||1.4|-6.8|0.1384
72470452|NCT04092452|144465172|SUPERIORITY||Risk Difference (RD)|-2.8|STANDARD_ERROR_OF_MEAN|2.66||0.1427|TWO_SIDED|90.0|-7.2|1.5||One-sided p-value|ANCOVA|||Week 12 - Statistical Analysis (MI) - Absolute Score||1.5|-7.2|0.1427
72470453|NCT04092452|144465172|SUPERIORITY||Risk Difference (RD)|-2.5|STANDARD_ERROR_OF_MEAN|2.99||0.1975|TWO_SIDED|90.0|-7.5|2.4||One-sided p-value|ANCOVA|||Week 16 - Statistical Analysis (MI) - Absolute Score||2.4|-7.5|0.1975
72470454|NCT04092452|144465172|SUPERIORITY||Risk Difference (RD)|-4.0|STANDARD_ERROR_OF_MEAN|2.76||0.0755|TWO_SIDED|90.0|-8.5|0.6||One-sided p-value|ANCOVA|||Week 16 - Statistical Analysis (MI) - Absolute Score||0.6|-8.5|0.0755
72470455|NCT04092452|144465172|SUPERIORITY||Risk Difference (RD)|-2.6|STANDARD_ERROR_OF_MEAN|2.89||0.1869|TWO_SIDED|90.0|-7.3|2.2||One-sided p-value|ANCOVA|||Week 16 - Statistical Analysis (MI) - Absolute Score||2.2|-7.3|0.1869
72470456|NCT04092452|144465173|SUPERIORITY||Risk Difference (RD)|-3.65|STANDARD_ERROR_OF_MEAN|8.659|||TWO_SIDED|90.0|-17.9|10.59||||||Week 1 - Statistical Analysis (MI) - Percent Change from Baseline||10.59|-17.90|
72470457|NCT04092452|144465173|SUPERIORITY||Risk Difference (RD)|-13.77|STANDARD_ERROR_OF_MEAN|8.749|||TWO_SIDED|90.0|-28.16|0.62||||||Week 1 - Statistical Analysis (MI) - Percent Change from Baseline||0.62|-28.16|
72470458|NCT04092452|144465173|SUPERIORITY||Risk Difference (RD)|-17.51|STANDARD_ERROR_OF_MEAN|8.752|||TWO_SIDED|90.0|-31.91|-3.12||||||Week 1 - Statistical Analysis (MI) - Percent Change from Baseline||-3.12|-31.91|
72470459|NCT04092452|144465173|SUPERIORITY||Risk Difference (RD)|-4.29|STANDARD_ERROR_OF_MEAN|10.103|||TWO_SIDED|90.0|-20.91|12.33||||||Week 2 - Statistical Analysis (MI) - Percent Change from Baseline||12.33|-20.91|
72505091|NCT01380093|144541446|SUPERIORITY_OR_OTHER||LS Mean Difference|76.0|||<|0.0001|TWO_SIDED|95.0|64.2|87.8|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||87.8|64.2|<0.0001
72505092|NCT01380093|144541447|SUPERIORITY_OR_OTHER||LS Mean Difference|-109.3|||<|0.0001|TWO_SIDED|95.0|-132.9|-85.6|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-85.6|-132.9|<0.0001
72470460|NCT04092452|144465173|SUPERIORITY||Risk Difference (RD)|-2.05|STANDARD_ERROR_OF_MEAN|9.904|||TWO_SIDED|90.0|-18.34|14.24||||||Week 2 - Statistical Analysis (MI) - Percent Change from Baseline||14.24|-18.34|
72470461|NCT04092452|144465173|SUPERIORITY||Risk Difference (RD)|0.17|STANDARD_ERROR_OF_MEAN|10.039|||TWO_SIDED|90.0|-16.34|16.68||||||Week 2 - Statistical Analysis (MI) - Percent Change from Baseline||16.68|-16.34|
72470462|NCT04092452|144465173|SUPERIORITY||Risk Difference (RD)|-0.46|STANDARD_ERROR_OF_MEAN|10.227|||TWO_SIDED|90.0|-17.29|16.36||||||Week 4 - Statistical Analysis (MI) - Percent Change from Baseline||16.36|-17.29|
72470463|NCT04092452|144465173|SUPERIORITY||Risk Difference (RD)|-8.07|STANDARD_ERROR_OF_MEAN|10.155|||TWO_SIDED|90.0|-24.77|8.63||||||Week 4 - Statistical Analysis (MI) - Percent Change from Baseline||8.63|-24.77|
72470464|NCT04092452|144465173|SUPERIORITY||Risk Difference (RD)|-6.06|STANDARD_ERROR_OF_MEAN|10.509|||TWO_SIDED|90.0|-23.35|11.22||||||Week 4 - Statistical Analysis (MI) - Percent Change from Baseline||11.22|-23.35|
72470465|NCT04092452|144465173|SUPERIORITY||Risk Difference (RD)|-3.54|STANDARD_ERROR_OF_MEAN|12.262|||TWO_SIDED|90.0|-23.71|16.63||||||Week 6 - Statistical Analysis (MI) - Percent Change from Baseline||16.63|-23.71|
72470466|NCT04092452|144465173|SUPERIORITY||Risk Difference (RD)|-16.26|STANDARD_ERROR_OF_MEAN|12.51|||TWO_SIDED|90.0|-36.84|4.32||||||Week 6 - Statistical Analysis (MI) - Percent Change from Baseline||4.32|-36.84|
72470467|NCT04092452|144465173|SUPERIORITY||Risk Difference (RD)|-12.52|STANDARD_ERROR_OF_MEAN|12.61|||TWO_SIDED|90.0|-33.27|8.22||||||Week 6 - Statistical Analysis (MI) - Percent Change from Baseline||8.22|-33.27|
72470468|NCT04092452|144465173|SUPERIORITY||Risk Difference (RD)|5.79|STANDARD_ERROR_OF_MEAN|11.045||0.7|TWO_SIDED|90.0|-12.38|23.96||One-sided p-value|ANCOVA|||Week 8 - Statistical Analysis (MI) - Percent Change from Baseline||23.96|-12.38|0.7000
72470469|NCT04092452|144465173|SUPERIORITY||Risk Difference (RD)|-5.81|STANDARD_ERROR_OF_MEAN|10.876||0.2965|TWO_SIDED|90.0|-23.7|12.08||One-sided p-value|ANCOVA|||Week 8 - Statistical Analysis (MI) - Percent Change from Baseline||12.08|-23.70|0.2965
72470470|NCT04092452|144465173|SUPERIORITY||Risk Difference (RD)|-11.33|STANDARD_ERROR_OF_MEAN|11.247||0.1568|TWO_SIDED|90.0|-29.83|7.17||One-sided p-value|ANCOVA|||Week 8 - Statistical Analysis (MI) - Percent Change from Baseline||7.17|-29.83|0.1568
72470471|NCT04092452|144465173|SUPERIORITY||Risk Difference (RD)|-6.78|STANDARD_ERROR_OF_MEAN|10.912||0.2672|TWO_SIDED|90.0|-24.73|11.17||One-sided p-value|ANCOVA|||Week 12 - Statistical Analysis (MI) - Percent Change from Baseline||11.17|-24.73|0.2672
72470472|NCT04092452|144465173|SUPERIORITY||Risk Difference (RD)|-16.57|STANDARD_ERROR_OF_MEAN|10.517||0.0576|TWO_SIDED|90.0|-33.87|0.73||One-sided p-value|ANCOVA|||Week 12 - Statistical Analysis (MI) - Percent Change from Baseline||0.73|-33.87|0.0576
72470473|NCT04092452|144465173|SUPERIORITY||Risk Difference (RD)|-13.65|STANDARD_ERROR_OF_MEAN|11.603||0.1197|TWO_SIDED|90.0|-32.74|5.44||One-sided p-value|ANCOVA|||Week 12 - Statistical Analysis (MI) - Percent Change from Baseline||5.44|-32.74|0.1197
72470474|NCT04092452|144465173|SUPERIORITY||Risk Difference (RD)|-5.63|STANDARD_ERROR_OF_MEAN|13.545||0.3388|TWO_SIDED|90.0|-27.91|16.65||One-sided p-value|ANCOVA|||Week 16 - Statistical Analysis (MI) - Percent Change from Baseline||16.65|-27.91|0.3388
72470475|NCT04092452|144465173|SUPERIORITY||Risk Difference (RD)|-14.8|STANDARD_ERROR_OF_MEAN|13.567||0.1376|TWO_SIDED|90.0|-37.12|7.51||One-sided p-value|ANCOVA|||Week 16 - Statistical Analysis (MI) - Percent Change from Baseline||7.51|-37.12|0.1376
72470476|NCT04092452|144465173|SUPERIORITY||Risk Difference (RD)|-8.32|STANDARD_ERROR_OF_MEAN|13.86||0.2741|TWO_SIDED|90.0|-31.12|14.48||One-sided p-value|ANCOVA|||Week 16||14.48|-31.12|0.2741
72470477|NCT04092452|144465174|SUPERIORITY||Risk Difference (RD)|-1.3|STANDARD_ERROR_OF_MEAN|7.06|||TWO_SIDED|90.0|-13.0|10.3||||||Week 4||10.3|-13.0|
72470478|NCT04092452|144465174|SUPERIORITY||Risk Difference (RD)|-8.5|STANDARD_ERROR_OF_MEAN|6.23|||TWO_SIDED|90.0|-18.7|1.8||||||Week 4||1.8|-18.7|
72470479|NCT04092452|144465174|SUPERIORITY||Risk Difference (RD)|1.7|STANDARD_ERROR_OF_MEAN|7.55|||TWO_SIDED|90.0|-10.7|14.1||||||Week 4||14.1|-10.7|
72470480|NCT04092452|144465174|SUPERIORITY||Risk Difference (RD)|6.6|STANDARD_ERROR_OF_MEAN|6.8||0.8372|TWO_SIDED|90.0|-4.6|17.7||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 8||17.7|-4.6|0.8372
72470481|NCT04092452|144465174|SUPERIORITY||Risk Difference (RD)|-6.4|STANDARD_ERROR_OF_MEAN|4.68||0.0819|TWO_SIDED|90.0|-14.1|1.3||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 8||1.3|-14.1|0.0819
72470482|NCT04092452|144465174|SUPERIORITY||Risk Difference (RD)|-8.0|STANDARD_ERROR_OF_MEAN|4.34||0.0242|TWO_SIDED|90.0|-15.2|-0.9||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 8||-0.9|-15.2|0.0242
72470483|NCT04092452|144465174|SUPERIORITY||Risk Difference (RD)|-12.7|STANDARD_ERROR_OF_MEAN|6.33||0.0264|TWO_SIDED|90.0|-23.1|-2.3||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 12||-2.3|-23.1|0.0264
72470484|NCT04092452|144465174|SUPERIORITY||Risk Difference (RD)|-14.5|STANDARD_ERROR_OF_MEAN|6.47||0.0127|TWO_SIDED|90.0|-25.1|-3.9||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 12||-3.9|-25.1|0.0127
72470485|NCT04092452|144465174|SUPERIORITY||Risk Difference (RD)|-16.6|STANDARD_ERROR_OF_MEAN|6.33||0.0059|TWO_SIDED|90.0|-27.0|-6.2||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 12||-6.2|-27.0|0.0059
72470486|NCT04092452|144465174|SUPERIORITY||Risk Difference (RD)|-9.6|STANDARD_ERROR_OF_MEAN|7.97||0.1185|TWO_SIDED|90.0|-22.7|3.5||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 16||3.5|-22.7|0.1185
72565341|NCT03360916|144662111|SUPERIORITY||Mean Difference (Net)|44.88|STANDARD_DEVIATION|105.19||0.1344|TWO_SIDED||||||t-test, 2 sided|This is within group 3 month change||||||0.1344
72565342|NCT03360916|144662112|SUPERIORITY||Mean Difference (Net)|0.22|STANDARD_DEVIATION|0.18||0.0005|TWO_SIDED||||||t-test, 2 sided|This is within group 3 month change||||||0.0005
72565343|NCT03360916|144662112|SUPERIORITY||Mean Difference (Net)|0.23|STANDARD_DEVIATION|0.21||0.0021|TWO_SIDED||||||t-test, 2 sided|This is within group 3 month change||||||0.0021
72565344|NCT03360916|144662112|SUPERIORITY||Mean Difference (Net)|0.21|STANDARD_DEVIATION|0.23||0.0025|TWO_SIDED||||||t-test, 2 sided|This is within group 3 month change||||||0.0025
72505093|NCT01380093|144541447|SUPERIORITY_OR_OTHER||LS Mean Difference|67.0|||<|0.0001|TWO_SIDED|95.0|43.5|90.6|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||90.6|43.5|<0.0001
72505094|NCT01380093|144541447|SUPERIORITY_OR_OTHER||LS Mean Difference|176.3|||<|0.0001|TWO_SIDED|95.0|152.6|199.9|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||199.9|152.6|<0.0001
72505095|NCT01380093|144541448|SUPERIORITY_OR_OTHER||LS Mean Difference|-190.8|||<|0.0001|TWO_SIDED|95.0|-234.2|-147.3|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-147.3|-234.2|<0.0001
72505096|NCT01380093|144541448|SUPERIORITY_OR_OTHER||LS Mean Difference|134.7|||<|0.0001|TWO_SIDED|95.0|91.5|178.0|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||178.0|91.5|<0.0001
72505097|NCT01380093|144541448|SUPERIORITY_OR_OTHER||LS Mean Difference|325.5|||<|0.0001|TWO_SIDED|95.0|282.1|368.9|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||368.9|282.1|<0.0001
72505098|NCT01380093|144541449|SUPERIORITY_OR_OTHER||LS Mean Difference|-244.9|||<|0.0001|TWO_SIDED|95.0|-302.0|-187.7|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-187.7|-302.0|<0.0001
72505099|NCT01380093|144541449|SUPERIORITY_OR_OTHER||LS Mean Difference|166.5|||<|0.0001|TWO_SIDED|95.0|109.5|223.5|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||223.5|109.5|<0.0001
72505100|NCT01380093|144541449|SUPERIORITY_OR_OTHER||LS Mean Difference|411.4|||<|0.0001|TWO_SIDED|95.0|354.3|468.6|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||468.6|354.3|<0.0001
72505101|NCT01380093|144541450|SUPERIORITY_OR_OTHER||LS Mean Difference|-310.0|||<|0.0001|TWO_SIDED|95.0|-384.5|-235.5|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-235.5|-384.5|<0.0001
72505102|NCT01380093|144541450|SUPERIORITY_OR_OTHER||LS Mean Difference|185.2|||<|0.0001|TWO_SIDED|95.0|110.8|259.5|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||259.5|110.8|<0.0001
72505103|NCT01380093|144541450|SUPERIORITY_OR_OTHER||LS Mean Difference|495.1|||<|0.0001|TWO_SIDED|95.0|420.6|569.7|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||569.7|420.6|<0.0001
72505104|NCT01380093|144541451|SUPERIORITY_OR_OTHER||LS Mean Difference|-30.5|||<|0.0001|TWO_SIDED|95.0|-38.7|-22.3|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-22.3|-38.7|<0.0001
72505105|NCT01380093|144541451|SUPERIORITY_OR_OTHER||LS Mean Difference|30.8|||<|0.0001|TWO_SIDED|95.0|22.6|39.0|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||39.0|22.6|<0.0001
72505106|NCT01380093|144541451|SUPERIORITY_OR_OTHER||LS Mean Difference|61.3|||<|0.0001|TWO_SIDED|95.0|53.1|69.5|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||69.5|53.1|<0.0001
72505107|NCT01380093|144541452|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1||||0.8671|TWO_SIDED|95.0|-1.0|0.8|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||0.8|-1.0|0.8671
72505108|NCT01380093|144541452|SUPERIORITY_OR_OTHER||LS Mean Difference|1.8||||0.0001|TWO_SIDED|95.0|0.9|2.7|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||2.7|0.9|0.0001
72505109|NCT01380093|144541452|SUPERIORITY_OR_OTHER||LS Mean Difference|1.9|||<|0.0001|TWO_SIDED|95.0|1.0|2.8|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||2.8|1.0|<0.0001
72505110|NCT01380093|144541453|SUPERIORITY_OR_OTHER||LS Mean Difference|-13.0|||<|0.0001|TWO_SIDED|95.0|-17.0|-9.0|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-9.0|-17.0|<0.0001
72505111|NCT01380093|144541453|SUPERIORITY_OR_OTHER||LS Mean Difference|8.8|||<|0.0001|TWO_SIDED|95.0|4.8|12.8|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||12.8|4.8|<0.0001
72505112|NCT01380093|144541453|SUPERIORITY_OR_OTHER||LS Mean Difference|21.8|||<|0.0001|TWO_SIDED|95.0|17.8|25.8|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||25.8|17.8|<0.0001
72505113|NCT01380093|144541454|SUPERIORITY_OR_OTHER||LS Mean Difference|-45.3|||<|0.0001|TWO_SIDED|95.0|-55.3|-35.3|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-35.3|-55.3|<0.0001
72470487|NCT04092452|144465174|SUPERIORITY||Risk Difference (RD)|-16.1|STANDARD_ERROR_OF_MEAN|6.39||0.004|TWO_SIDED|90.0|-26.6|-5.6||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 16||-5.6|-26.6|0.0040
72470488|NCT04092452|144465174|SUPERIORITY||Risk Difference (RD)|-12.8|STANDARD_ERROR_OF_MEAN|7.09||0.0418|TWO_SIDED|90.0|-24.5|-1.1||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 16||-1.1|-24.5|0.0418
72622528|NCT03715829|144775122|SUPERIORITY||Least Squares Mean Difference (Net)|-16.7|STANDARD_ERROR_OF_MEAN|6.71||0.0068|TWO_SIDED|90.0|-27.77|-5.61||Hochberg's step-up procedure was conducted to compare the ritlecitinib 30 mg QD dose group vs placebo using observed p-values. The familywise Type 1 error rate was controlled at one-sided 0.05. One-sided unadjusted p-value is presented here.|ANCOVA|||||-5.61|-27.77|0.0068
72470489|NCT04092452|144465175|SUPERIORITY||Risk Difference (RD)|12.1|STANDARD_ERROR_OF_MEAN|7.75||0.0559|TWO_SIDED|90.0|-0.7|24.8||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 1 (Pain at its Worst)||24.8|-0.7|0.0559
72470490|NCT04092452|144465175|SUPERIORITY||Risk Difference (RD)|9.8|STANDARD_ERROR_OF_MEAN|7.09||0.0758|TWO_SIDED|90.0|-1.9|21.4||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 1 (Pain at its Worst)||21.4|-1.9|0.0758
72505114|NCT01380093|144541454|SUPERIORITY_OR_OTHER||LS Mean Difference|24.5|||<|0.0001|TWO_SIDED|95.0|14.6|34.5|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||34.5|14.6|<0.0001
72505115|NCT01380093|144541454|SUPERIORITY_OR_OTHER||LS Mean Difference|69.8|||<|0.0001|TWO_SIDED|95.0|59.9|79.8|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||79.8|59.9|<0.0001
72505116|NCT01380093|144541455|SUPERIORITY_OR_OTHER||LS Mean Difference|-109.1|||<|0.0001|TWO_SIDED|95.0|-129.3|-88.8|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-88.8|-129.3|<0.0001
72505117|NCT01380093|144541455|SUPERIORITY_OR_OTHER||LS Mean Difference|60.1|||<|0.0001|TWO_SIDED|95.0|39.9|80.4|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||80.4|39.9|<0.0001
72505118|NCT01380093|144541455|SUPERIORITY_OR_OTHER||LS Mean Difference|169.2|||<|0.0001|TWO_SIDED|95.0|148.9|189.5|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||189.5|148.9|<0.0001
72505119|NCT01380093|144541456|SUPERIORITY_OR_OTHER||LS Mean Difference|-207.0|||<|0.0001|TWO_SIDED|95.0|-242.0|-172.1|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-172.1|-242.0|<0.0001
72505120|NCT01380093|144541456|SUPERIORITY_OR_OTHER||LS Mean Difference|118.7|||<|0.0001|TWO_SIDED|95.0|83.9|153.5|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||153.5|83.9|<0.0001
72505121|NCT01380093|144541456|SUPERIORITY_OR_OTHER||LS Mean Difference|325.8|||<|0.0001|TWO_SIDED|95.0|290.8|360.7|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||360.7|290.8|<0.0001
72505122|NCT01380093|144541457|SUPERIORITY_OR_OTHER||LS Mean Difference|-268.2|||<|0.0001|TWO_SIDED|95.0|-313.2|-223.2|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-223.2|-313.2|<0.0001
72505123|NCT01380093|144541457|SUPERIORITY_OR_OTHER||LS Mean Difference|147.0|||<|0.0001|TWO_SIDED|95.0|102.1|191.9|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||191.9|102.1|<0.0001
72505124|NCT01380093|144541457|SUPERIORITY_OR_OTHER||LS Mean Difference|415.2|||<|0.0001|TWO_SIDED|95.0|370.2|460.2|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||460.2|370.2|<0.0001
72505125|NCT01380093|144541458|SUPERIORITY_OR_OTHER||LS Mean Difference|-336.0|||<|0.0001|TWO_SIDED|95.0|-395.4|-276.6|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-276.6|-395.4|<0.0001
72505126|NCT01380093|144541458|SUPERIORITY_OR_OTHER||LS Mean Difference|165.6|||<|0.0001|TWO_SIDED|95.0|106.4|224.8|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||224.8|106.4|<0.0001
72505127|NCT01380093|144541458|SUPERIORITY_OR_OTHER||LS Mean Difference|501.6|||<|0.0001|TWO_SIDED|95.0|442.2|561.0|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||561.0|442.2|<0.0001
72505128|NCT01380093|144541459|SUPERIORITY_OR_OTHER||LS Mean Difference|-33.8|||<|0.0001|TWO_SIDED|95.0|-40.7|-26.8|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-26.8|-40.7|<0.0001
72395209|NCT05355805|144297059|SUPERIORITY||Risk Difference (RD)|7.48|STANDARD_ERROR_OF_MEAN|8.951||0.4031|TWO_SIDED|||||The estimated risk difference divided by the standard error was used as the test statistic and a p-value calculated assuming that the test statistic follows a standard normal distribution under the null hypothesis.|Cochran-Mantel-Haenszel|||The common risk difference between placebo QW/Q2W and the izokibep 160 mg QW arm among the four strata, prior biologic/JAK inhibitor use for HS (Yes/No) and Hurley Stage (II or III), used for randomization and associated standard error will be estimated by combining the observed risk differences using Cochran-Mantel-Haenszel weighting.||||0.4031
72395210|NCT05355805|144297059|SUPERIORITY||Risk Difference (RD)|21.27|STANDARD_ERROR_OF_MEAN|9.959||0.0327|TWO_SIDED|||||The estimated risk difference divided by the standard error was used as the test statistic and a p-value calculated assuming that the test statistic follows a standard normal distribution under the null hypothesis.|Cochran-Mantel-Haenszel|||The common risk difference between placebo QW/Q2W and the izokibep 160 mg Q2W arm among the four strata, prior biologic/JAK inhibitor use for HS (Yes/No) and Hurley Stage (II or III), used for randomization and associated standard error will be estimated by combining the observed risk differences using Cochran-Mantel-Haenszel weighting.||||0.0327
72395211|NCT01804075|144297097|SUPERIORITY|||||||0.6|||||||Chi-squared|||||||0.6
72395212|NCT00524368|144297098|NON_INFERIORITY_OR_EQUIVALENCE|If at Week 48, the lower limit of the 95% two-sided confidence interval of the difference between DRV/rtv once daily and DRV/rtv twice daily exceeds -12%, non-inferiority of the DRV/rtv q.d. versus the DRV/rtv b.i.d. therapy was concluded.|Difference in proportion of response|0.0019|STANDARD_ERROR_OF_MEAN|0.037|<|0.001|TWO_SIDED|95.0|-0.054|0.092|||Regression, Logistic|The model includes treatment as factor and baseline viral load (log10) as covariate.|Difference in proportion of response DRV/rtv once daily minus DRV/rtv twice daily estimated from the logistic regression model.|Assuming a response rate of 70% at 48 weeks for both treatment groups, 306 participants were required per treatment arm to establish noninferiority of darunavir (DRV)/ritonavir (rtv) once daily versus DRV/rtv twice daily with a maximum allowable difference of 12%, with a 1-sided significance level of 0.025 and 90% power.||0.092|-0.054|<0.001
72395213|NCT00524368|144297099|NON_INFERIORITY_OR_EQUIVALENCE|If at Week 48, the lower limit of this 95% 2-sided CI of the difference between DRV/rtv q.d. and DRV/rtv b.i.d. exceeded -12%, noninferiority of DRV/rtv q.d. and DRV/rtv b.i.d. could be concluded.|Difference in proportion of response|0.007|STANDARD_ERROR_OF_MEAN|0.034|<|0.001|TWO_SIDED|95.0|-0.06|0.075|||Regression, Logistic|A logistic regression model includes treatment as fixed factor and baseline plasma viral load as a covariate.|Difference in proportion of response between 2 treatment groups (DRV/rtv q.d. minus DRV/rtv b.i.d)|||0.075|-0.060|<0.001
72470491|NCT04092452|144465175|SUPERIORITY||Risk Difference (RD)|11.3|STANDARD_ERROR_OF_MEAN|7.21||0.0637|TWO_SIDED|90.0|-0.6|23.2||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 1 (Pain at its Worst)||23.2|-0.6|0.0637
72565345|NCT03053583|144662116|SUPERIORITY||||||<|0.05|||||||Kruskal-Wallis|||Posthoc analysis of POGO scores were compared using the Kruskall Wallis test with Mann-WHitney test for pairwise comparisons||||<0.05
72565346|NCT03005067|144662130|OTHER||Mean Difference (Net)|0.137||||0.516|TWO_SIDED|95.0|-0.279|0.553||P-value was based on the Wald statistic Chi-Square test, from an ANCOVA model with treatment, center, and Day 1 dosing time stratification as factors and baseline NSS (Day 1 prior to the first dose) as a covariate.|ANCOVA||Difference of LS mean is 1146A Formulation Nasal Spray - Placebo Nasal Spray. 95% CI is for difference of LS means.|||0.553|-0.279|0.516
72395214|NCT00524368|144297100|SUPERIORITY_OR_OTHER||Difference between least square means|-0.003|STANDARD_ERROR_OF_MEAN|0.094||0.977|TWO_SIDED|95.0|-0.188|0.182|||ANCOVA|Including 1 factor for treatment, and including the covariate baseline log10 plasma viral load|Difference between least square means between the DRV/rtv q.d. and DRV/rtv b.i.d. treatment groups at Week 48.|||0.182|-0.188|0.977
72395215|NCT00524368|144297101|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.99|STANDARD_ERROR_OF_MEAN|0.094||0.917|TWO_SIDED|95.0|0.824|1.191|||Cox proportional hazards|Including treatment as fixed factor and baseline plasma viral load as a covariate||||1.191|0.824|0.917
72470492|NCT04092452|144465175|SUPERIORITY||Risk Difference (RD)|4.2|STANDARD_ERROR_OF_MEAN|8.84||0.3179|TWO_SIDED|90.0|-10.3|18.8||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 2 (Pain at its Worst)||18.8|-10.3|0.3179
72576658|NCT01635218|144680104|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.28|STANDARD_ERROR_OF_MEAN|1.73||0.99|TWO_SIDED|95.0|-2.93|5.5||The ANOVA result (p\<0.05)suggests rejecting the global null hypothesis.Bonferroni post-hoc test was used to determine which means differ among groups.|ANOVA|||||5.5|-2.93|0.99
72395216|NCT00524368|144297102|SUPERIORITY_OR_OTHER||Hazard Ratio, log|0.945|STANDARD_ERROR_OF_MEAN|0.154||0.716|TWO_SIDED|95.0|0.699|1.279|||Regression, Cox|Including baseline log10 viral load as covariate||||1.279|0.699|0.716
72470493|NCT04092452|144465175|SUPERIORITY||Risk Difference (RD)|11.0|STANDARD_ERROR_OF_MEAN|8.82||0.1078|TWO_SIDED|90.0|-3.5|25.5||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 2 (Pain at its Worst)||25.5|-3.5|0.1078
72576659|NCT01635218|144680105|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.11|||<|0.05|TWO_SIDED|95.0|0.03|0.34|||Chi-squared|||||0.34|0.03|<0.05
72576660|NCT01635218|144680105|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.19|||<|0.05|TWO_SIDED|95.0|0.06|0.56|||Chi-squared|||||0.56|0.06|<0.05
72576661|NCT01635218|144680106|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.6|STANDARD_ERROR_OF_MEAN|2.42||0.002|TWO_SIDED|95.0|2.72|14.52||The ANOVA result (p\<0.05)suggests rejecting the global null hypothesis.Bonferroni post-hoc test was used to determine which means differ among groups.|ANOVA|||||14.52|2.72|0.002
72576662|NCT01635218|144680106|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.6|STANDARD_ERROR_OF_MEAN|2.37||0.424|TWO_SIDED|95.0|-2.33|9.6||The ANOVA result (p\<0.05)suggests rejecting the global null hypothesis.Bonferroni post-hoc test was used to determine which means differ among groups.|ANOVA|||||9.6|-2.33|0.424
72576663|NCT01635218|144680107|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.26||||0.1||95.0|0.05|1.32|||Chi-squared|||||1.32|0.05|0.10
72576664|NCT01635218|144680107|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.27||||0.11|TWO_SIDED|95.0|0.05|1.39|||Chi-squared|||||1.39|0.05|0.11
72576665|NCT03262038|144680120|SUPERIORITY|||||||0.412|||||||Chi-squared|||||||.412
72576666|NCT03262038|144680121|SUPERIORITY|||||||0.633|||||||Chi-squared|||||||.633
72395217|NCT00524368|144297103|SUPERIORITY_OR_OTHER||Difference in least square means|-0.03|STANDARD_ERROR_OF_MEAN|0.072||0.711|TWO_SIDED|95.0|-0.169|0.115|||ANCOVA|Including 1 factor for treatment, and including the covariate baseline log10 plasma viral load|Difference in least square means between the 2 treatment groups (DRV/rtv q.d. and DRV/rtv b.i.d)|||0.115|-0.169|0.711
72395218|NCT00524368|144297104|SUPERIORITY_OR_OTHER||Difference in least square means|-5.95|STANDARD_ERROR_OF_MEAN|10.26||0.562|TWO_SIDED|95.0|-26.09|14.2|||ANCOVA|The model includes treatment as factor and baseline CD4 count and baseline viral load (log10) as covariates.|Difference in least square means DRV/rtv once daily minus DRV/rtv twice daily estimated from the ANCOVA model.|||14.20|-26.09|0.562
72395219|NCT00524368|144297105|SUPERIORITY_OR_OTHER||Difference in least square means|0.55|STANDARD_ERROR_OF_MEAN|1.79||0.761|TWO_SIDED|95.0|-2.97|4.06|||ANCOVA|Including factors for treatment, and baseline log10 plasma viral load and baseline FAHI score as covariates|Difference in least square means DRV/rtv once daily minus DRV/rtv twice daily estimated from the ANCOVA model.|||4.06|-2.97|0.761
72470494|NCT04092452|144465175|SUPERIORITY||Risk Difference (RD)|7.6|STANDARD_ERROR_OF_MEAN|8.86||0.1976|TWO_SIDED|90.0|-7.0|22.2||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 2 (Pain at its Worst)||22.2|-7.0|0.1976
72470495|NCT04092452|144465175|SUPERIORITY||Risk Difference (RD)|-18.9|STANDARD_ERROR_OF_MEAN|9.32||0.9738|TWO_SIDED|90.0|-34.3|-3.6||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 4 (Pain at its Worst)||-3.6|-34.3|0.9738
72470496|NCT04092452|144465175|SUPERIORITY||Risk Difference (RD)|5.8|STANDARD_ERROR_OF_MEAN|10.4||0.2925|TWO_SIDED|90.0|-11.3|22.9||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 4 (Pain at its Worst)||22.9|-11.3|0.2925
72470497|NCT04092452|144465175|SUPERIORITY||Risk Difference (RD)|-3.1|STANDARD_ERROR_OF_MEAN|10.18||0.6178|TWO_SIDED|90.0|-19.8|13.7||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 4 (Pain at its Worst)||13.7|-19.8|0.6178
72470498|NCT04092452|144465175|SUPERIORITY||Risk Difference (RD)|-20.9|STANDARD_ERROR_OF_MEAN|10.04||0.9769|TWO_SIDED|90.0|-37.4|-4.4||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 6 (Pain at its Worst)||-4.4|-37.4|0.9769
72470499|NCT04092452|144465175|SUPERIORITY||Risk Difference (RD)|-4.2|STANDARD_ERROR_OF_MEAN|10.57||0.6529|TWO_SIDED|90.0|-21.6|13.2||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 6 (Pain at its Worst)||13.2|-21.6|0.6529
72470500|NCT04092452|144465175|SUPERIORITY||Risk Difference (RD)|-12.8|STANDARD_ERROR_OF_MEAN|10.36||0.8878|TWO_SIDED|90.0|-29.8|4.3||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 6 (Pain at its Worst)||4.3|-29.8|0.8878
72470501|NCT04092452|144465175|SUPERIORITY||Risk Difference (RD)|-6.2|STANDARD_ERROR_OF_MEAN|10.11||0.7259|TWO_SIDED|90.0|-22.9|10.4||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 8 (Pain at its Worst)||10.4|-22.9|0.7259
72470502|NCT04092452|144465175|SUPERIORITY||Risk Difference (RD)|14.8|STANDARD_ERROR_OF_MEAN|10.24||0.0826|TWO_SIDED|90.0|-2.1|31.6||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 8 (Pain at its Worst)||31.6|-2.1|0.0826
72470503|NCT04092452|144465175|SUPERIORITY||Risk Difference (RD)|-8.0|STANDARD_ERROR_OF_MEAN|9.75||0.7884|TWO_SIDED|90.0|-24.1|8.0||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 8 (Pain at its Worst)||8.0|-24.1|0.7884
72470504|NCT04092452|144465175|SUPERIORITY||Risk Difference (RD)|-16.1|STANDARD_ERROR_OF_MEAN|10.43||0.9326|TWO_SIDED|90.0|-33.2|1.1||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 12 (Pain at its Worst)||1.1|-33.2|0.9326
72470505|NCT04092452|144465175|SUPERIORITY||Risk Difference (RD)|-4.9|STANDARD_ERROR_OF_MEAN|10.41||0.681|TWO_SIDED|90.0|-22.1|12.2||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 12 (Pain at its Worst)||12.2|-22.1|0.6810
72470506|NCT04092452|144465175|SUPERIORITY||Risk Difference (RD)|-10.3|STANDARD_ERROR_OF_MEAN|10.52||0.8308|TWO_SIDED|90.0|-27.6|7.0||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 12 (Pain at its Worst)||7.0|-27.6|0.8308
72470507|NCT04092452|144465175|SUPERIORITY||Risk Difference (RD)|-8.5|STANDARD_ERROR_OF_MEAN|9.71||0.8063|TWO_SIDED|90.0|-24.5|7.4||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 16 (Pain at its Worst)||7.4|-24.5|0.8063
72470508|NCT04092452|144465175|SUPERIORITY||Risk Difference (RD)|6.5|STANDARD_ERROR_OF_MEAN|10.27||0.2649|TWO_SIDED|90.0|-10.4|23.4||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 16 (Pain at its Worst)||23.4|-10.4|0.2649
72576667|NCT03262038|144680122|SUPERIORITY|||||||0.007|||||||Chi-squared|||||||.007
72576668|NCT03262038|144680123|SUPERIORITY|||||||0.634|||||||Chi-squared|||||||.634
72395220|NCT02785354|144297137|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.58|||<|0.0001|TWO_SIDED|95.0|0.51|0.66|||Fine and Gray model|||Outcome was analyzed during dabigatran or VKA exposure period (on treatment) using: 1) Cumulative function to estimate the incidence (with death as a competing risk), 2) Fine and Gray model to compare the 1-year risk for dabigatran versus VKA, with hazard ratio (HR) and 95% Confidence Interval (CI ) (and death as a competing risk).||0.66|0.51|<0.0001
72470509|NCT04092452|144465175|SUPERIORITY||Risk Difference (RD)|5.3|STANDARD_ERROR_OF_MEAN|10.35||0.3029|TWO_SIDED|90.0|-11.7|22.4||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 16 (Pain at its Worst)||22.4|-11.7|0.3029
72470510|NCT04092452|144465176|SUPERIORITY||Risk Difference (RD)|7.7|STANDARD_ERROR_OF_MEAN|8.2||0.1687|TWO_SIDED|90.0|-5.7|21.2||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 1 (Average Pain)||21.2|-5.7|0.1687
72470511|NCT04092452|144465176|SUPERIORITY||Risk Difference (RD)|13.8|STANDARD_ERROR_OF_MEAN|8.03||0.0376|TWO_SIDED|90.0|0.6|27.0||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 1 (Average Pain)||27.0|0.6|0.0376
72470512|NCT04092452|144465176|SUPERIORITY||Risk Difference (RD)|-1.5|STANDARD_ERROR_OF_MEAN|6.9||0.5883|TWO_SIDED|90.0|-12.9|9.8||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 1 (Average Pain)||9.8|-12.9|0.5883
72470513|NCT04092452|144465176|SUPERIORITY||Risk Difference (RD)|2.7|STANDARD_ERROR_OF_MEAN|9.07||0.3829|TWO_SIDED|90.0|-12.2|17.6||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 2 (Average Pain)||17.6|-12.2|0.3829
72470514|NCT04092452|144465176|SUPERIORITY||Risk Difference (RD)|18.2|STANDARD_ERROR_OF_MEAN|9.54||0.0316|TWO_SIDED|90.0|2.5|33.9||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 2 (Average Pain)||33.9|2.5|0.0316
72470515|NCT04092452|144465176|SUPERIORITY||Risk Difference (RD)|4.6|STANDARD_ERROR_OF_MEAN|9.17||0.3072|TWO_SIDED|90.0|-10.5|19.7||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 2 (Average Pain)||19.7|-10.5|0.3072
72470516|NCT04092452|144465176|SUPERIORITY||Risk Difference (RD)|-13.1|STANDARD_ERROR_OF_MEAN|10.18||0.8952|TWO_SIDED|90.0|-29.8|3.7||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 4 (Average Pain)||3.7|-29.8|0.8952
72470517|NCT04092452|144465176|SUPERIORITY||Risk Difference (RD)|13.1|STANDARD_ERROR_OF_MEAN|10.76||0.1157|TWO_SIDED|90.0|-4.6|30.8||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 4 (Average Pain)||30.8|-4.6|0.1157
72470518|NCT04092452|144465176|SUPERIORITY||Risk Difference (RD)|0.9|STANDARD_ERROR_OF_MEAN|10.93||0.4672|TWO_SIDED|90.0|-17.1|18.9||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 4 (Average Pain)||18.9|-17.1|0.4672
72470519|NCT04092452|144465176|SUPERIORITY||Risk Difference (RD)|-16.9|STANDARD_ERROR_OF_MEAN|11.29||0.9287|TWO_SIDED|90.0|-35.5|1.6||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 6 (Average Pain)||1.6|-35.5|0.9287
72470520|NCT04092452|144465176|SUPERIORITY||Risk Difference (RD)|0.0|STANDARD_ERROR_OF_MEAN|10.85||0.4984|TWO_SIDED|90.0|-17.8|17.9||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 6 (Average Pain)||17.9|-17.8|0.4984
72505129|NCT01380093|144541459|SUPERIORITY_OR_OTHER||LS Mean Difference|26.7|||<|0.0001|TWO_SIDED|95.0|19.7|33.6|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||33.6|19.7|<0.0001
72395221|NCT02785354|144297137|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.83||||0.0006|TWO_SIDED|95.0|0.75|0.92|||Fine and Gray model|||Outcome was analyzed during rivaroxaban or VKA exposure period (on treatment) using: 1) Cumulative function to estimate the incidence (with death as a competing risk), 2) Fine and Gray model to compare the 1-year risk for rivaroxaban versus VKA, with HR and 95%CI (and death as a competing risk).||0.92|0.75|0.0006
72470521|NCT04092452|144465176|SUPERIORITY||Risk Difference (RD)|-14.7|STANDARD_ERROR_OF_MEAN|11.27||0.9001|TWO_SIDED|90.0|-33.2|3.9||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 6 (Average Pain)||3.9|-33.2|0.9001
72470522|NCT04092452|144465176|SUPERIORITY||Risk Difference (RD)|-10.3|STANDARD_ERROR_OF_MEAN|10.53||0.8319|TWO_SIDED|90.0|-27.6|7.0||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 8 (Average Pain)||7.0|-27.6|0.8319
72470523|NCT04092452|144465176|SUPERIORITY||Risk Difference (RD)|19.7|STANDARD_ERROR_OF_MEAN|10.55||0.034|TWO_SIDED|90.0|2.3|37.0||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 8 (Average Pain)||37.0|2.3|0.0340
72505130|NCT01380093|144541459|SUPERIORITY_OR_OTHER||LS Mean Difference|60.4|||<|0.0001|TWO_SIDED|95.0|53.4|67.4|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||67.4|53.4|<0.0001
72505131|NCT01380093|144541460|SUPERIORITY_OR_OTHER||LS Mean Difference|0.4||||0.3345|TWO_SIDED|95.0|-0.4|1.3|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||1.3|-0.4|0.3345
72395222|NCT02785354|144297138|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.55|||<|0.0001|TWO_SIDED|95.0|0.46|0.66|||Fine and Gray model|||Outcome was analyzed during dabigatran or VKA exposure period (on treatment) using: 1) Cumulative function to estimate the incidence (with death as a competing risk), 2) Fine and Gray model to compare the 1-year risk for dabigatran versus VKA, with hazard ratio (HR) and 95%CI (and death as a competing risk).||0.66|0.46|<0.0001
72505132|NCT01380093|144541460|SUPERIORITY_OR_OTHER||LS Mean Difference|2.4|||<|0.0001|TWO_SIDED|95.0|1.5|3.3|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||3.3|1.5|<0.0001
72505133|NCT01380093|144541460|SUPERIORITY_OR_OTHER||LS Mean Difference|2.0|||<|0.0001|TWO_SIDED|95.0|1.1|2.8|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||2.8|1.1|<0.0001
72505134|NCT01380093|144541461|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.0||||0.0453|TWO_SIDED|95.0|-2.0|0.0|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-0.0|-2.0|0.0453
72505135|NCT01380093|144541461|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3||||0.5637|TWO_SIDED|95.0|-0.7|1.3|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||1.3|-0.7|0.5637
72505136|NCT01380093|144541461|SUPERIORITY_OR_OTHER||LS Mean Difference|1.3||||0.011|TWO_SIDED|95.0|0.3|2.3|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||2.3|0.3|0.0110
72505137|NCT01380093|144541462|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.9||||0.0041|TWO_SIDED|95.0|-8.2|-1.6|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-1.6|-8.2|0.0041
72505138|NCT01380093|144541462|SUPERIORITY_OR_OTHER||LS Mean Difference|2.1||||0.2178|TWO_SIDED|95.0|-1.2|5.3|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||5.3|-1.2|0.2178
72505139|NCT01380093|144541462|SUPERIORITY_OR_OTHER||LS Mean Difference|7.0|||<|0.0001|TWO_SIDED|95.0|3.7|10.3|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||10.3|3.7|<0.0001
72505140|NCT01380093|144541463|SUPERIORITY_OR_OTHER||LS Mean Difference|-19.4||||0.0001|TWO_SIDED|95.0|-28.8|-9.9|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-9.9|-28.8|0.0001
72505141|NCT01380093|144541463|SUPERIORITY_OR_OTHER||LS Mean Difference|6.9||||0.151|TWO_SIDED|95.0|-2.6|16.3|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||16.3|-2.6|0.1510
72505142|NCT01380093|144541463|SUPERIORITY_OR_OTHER||LS Mean Difference|26.2|||<|0.0001|TWO_SIDED|95.0|16.8|35.7|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||35.7|16.8|<0.0001
72505143|NCT01380093|144541464|SUPERIORITY_OR_OTHER||LS Mean Difference|-55.2|||<|0.0001|TWO_SIDED|95.0|-75.9|-34.4|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-34.4|-75.9|<0.0001
72505144|NCT01380093|144541464|SUPERIORITY_OR_OTHER||LS Mean Difference|18.5||||0.0796|TWO_SIDED|95.0|-2.2|39.2|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||39.2|-2.2|0.0796
72505145|NCT01380093|144541464|SUPERIORITY_OR_OTHER||LS Mean Difference|73.6|||<|0.0001|TWO_SIDED|95.0|52.9|94.4|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||94.4|52.9|<0.0001
72505146|NCT01380093|144541465|SUPERIORITY_OR_OTHER||LS Mean Difference|-82.8|||<|0.0001|TWO_SIDED|95.0|-112.9|-52.7|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-52.7|-112.9|<0.0001
72505147|NCT01380093|144541465|SUPERIORITY_OR_OTHER||LS Mean Difference|26.9||||0.078|TWO_SIDED|95.0|-3.1|56.9|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||56.9|-3.1|0.0780
72505148|NCT01380093|144541465|SUPERIORITY_OR_OTHER||LS Mean Difference|109.7|||<|0.0001|TWO_SIDED|95.0|79.6|139.8|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||139.8|79.6|<0.0001
72505149|NCT01380093|144541466|SUPERIORITY_OR_OTHER||LS Mean Difference|-111.9|||<|0.0001|TWO_SIDED|95.0|-153.7|-70.2|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-70.2|-153.7|<0.0001
72505150|NCT01380093|144541466|SUPERIORITY_OR_OTHER||LS Mean Difference|33.9||||0.1089|TWO_SIDED|95.0|-7.8|75.5|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||75.5|-7.8|0.1089
72505151|NCT01380093|144541466|SUPERIORITY_OR_OTHER||LS Mean Difference|145.8|||<|0.0001|TWO_SIDED|95.0|104.1|187.5|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||187.5|104.1|<0.0001
72505152|NCT01380093|144541467|SUPERIORITY_OR_OTHER||LS Mean Difference|-13.7|||<|0.0001|TWO_SIDED|95.0|-18.8|-8.6|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-8.6|-18.8|<0.0001
72505153|NCT01380093|144541467|SUPERIORITY_OR_OTHER||LS Mean Difference|6.0||||0.0215|TWO_SIDED|95.0|0.9|11.1|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||11.1|0.9|0.0215
72395223|NCT02785354|144297138|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.68|||<|0.0001|TWO_SIDED|95.0|0.58|0.79|||Fine and Gray model|||Outcome was analyzed during rivaroxaban or VKA exposure period (on treatment) using: 1) Cumulative function to estimate the incidence (with death as a competing risk), 2) Fine and Gray model to compare the 1-year risk for rivaroxaban versus VKA, with HR and 95%CI (and death as a competing risk).||0.79|0.58|<0.0001
72565347|NCT00619359|144662138|NON_INFERIORITY_OR_EQUIVALENCE|If the CI for the difference in response rates (Fosaprepitant minus Aprepitant), calculated using the methodology of Miettinen and Nurminen, had a lower limit ≥7 percentage points, fosaprepitant was considered at least as effective as aprepitant for Complete Response in the overall phase. Study had 90% power to detect non-inferiority for this outcome measure.|Risk Difference (RD)|-0.4|STANDARD_ERROR_OF_MEAN|3.7||||95.0|-4.1|3.3||||||||3.3|-4.1|
72565348|NCT00619359|144662139|NON_INFERIORITY_OR_EQUIVALENCE|If the CI for the difference in response rates, calculated using the methodology of Miettinen and Nurminen, had a lower limit ≥7.3 percentage points, fosaprepitant was considered at least as effective as aprepitant for Complete Response in the delayed phase.|Risk Difference (RD)|0.1|STANDARD_ERROR_OF_MEAN|3.6||||95.0|-3.5|3.7||||||||3.7|-3.5|
72565349|NCT00619359|144662140|NON_INFERIORITY_OR_EQUIVALENCE|If the CI for the difference in response rates, calculated using the methodology of Miettinen and Nurminen, had a lower limit ≥8.2 percentage points, fosaprepitant was considered at least as effective as aprepitant for No Vomiting in the overall phase.|Risk Difference (RD)|-1.7|STANDARD_ERROR_OF_MEAN|3.6||||95.0|-5.3|2.0||||||||2.0|-5.3|
72565350|NCT02296853|144662141|EQUIVALENCE|"Sample size calculations were done in Query Advisor 6.0 by using the Two-group t-test of equal means (equal n's) module with α (one-sided) = 0.05, upper equivalence limit = ln(2.0) = 0.691, and expected difference = 0."|GLSM ratio percentage|54.04|||||TWO_SIDED|90.0|41.98|69.56|||||Here, GLSM is geometric least square mean.|TAF: Severe Hepatic Impairment Group vs. Matched Normal Hepatic Function Group||69.56|41.98|
72565351|NCT02296853|144662141|EQUIVALENCE|"Sample size calculations were done in Query Advisor 6.0 by using the Two-group t-test of equal means (equal n's) module with α (one-sided) = 0.05, upper equivalence limit = ln(2.0) = 0.691, and expected difference = 0."|GLSM ratio percentage|63.06|||||TWO_SIDED|90.0|42.9|92.7||||||TFV: Severe Hepatic Impairment Group vs. Matched Normal Hepatic Function Group||92.70|42.90|
72565352|NCT02296853|144662141|EQUIVALENCE|"Sample size calculations were done in Query Advisor 6.0 by using the Two-group t-test of equal means (equal n's) module with α (one-sided) = 0.05, upper equivalence limit = ln(2.0) = 0.691, and expected difference = 0."|GLSM ratio percentage|94.42|||||TWO_SIDED|90.0|72.48|122.99||||||Free (unbound) TAF: Severe Hepatic Impairment Group vs. Matched Normal Hepatic Function Group||122.99|72.48|
72565353|NCT02296853|144662142|EQUIVALENCE|"Sample size calculations were done in Query Advisor 6.0 by using the Two-group t-test of equal means (equal n's) module with α (one-sided) = 0.05, upper equivalence limit = ln(2.0) = 0.691, and expected difference = 0."|GLSM ratio percentage|45.1|||||TWO_SIDED|90.0|31.66|64.25||||||TAF: Severe Hepatic Impairment Group vs. Matched Normal Hepatic Function Group||64.25|31.66|
72565354|NCT02296853|144662142|EQUIVALENCE|"Sample size calculations were done in Query Advisor 6.0 by using the Two-group t-test of equal means (equal n's) module with α (one-sided) = 0.05, upper equivalence limit = ln(2.0) = 0.691, and expected difference = 0."|GLSM ratio percentage|89.88|||||TWO_SIDED|90.0|64.77|124.72||||||TFV: Severe Hepatic Impairment Group vs. Matched Normal Hepatic Function Group||124.72|64.77|
72565355|NCT02296853|144662142|EQUIVALENCE|"Sample size calculations were done in Query Advisor 6.0 by using the Two-group t-test of equal means (equal n's) module with α (one-sided) = 0.05, upper equivalence limit = ln(2.0) = 0.691, and expected difference = 0."|GLSM ratio percentage|82.16|||||TWO_SIDED|90.0|56.58|119.31||"Sample size calculations were done in Query Advisor 6.0 by using the Two-group t-test of equal means (equal n's) module with α (one-sided) = 0.05, upper equivalence limit = ln(2.0) = 0.691, and expected difference = 0."||||Free (unbound) TAF: Severe Hepatic Impairment Group vs. Matched Normal Hepatic Function Group||119.31|56.58|
72565356|NCT02296853|144662143|EQUIVALENCE|"Sample size calculations were done in Query Advisor 6.0 by using the Two-group t-test of equal means (equal n's) module with α (one-sided) = 0.05, upper equivalence limit = ln(2.0) = 0.691, and expected difference = 0."|GLSM ratio percentage|51.2|||||TWO_SIDED|90.0|40.11|65.36||||||TAF: Severe Hepatic Impairment Group vs. Matched Normal Hepatic Function Group||65.36|40.11|
72565357|NCT02296853|144662143|EQUIVALENCE|"Sample size calculations were done in Query Advisor 6.0 by using the Two-group t-test of equal means (equal n's) module with α (one-sided) = 0.05, upper equivalence limit = ln(2.0) = 0.691, and expected difference = 0."|GLSM ratio percentage|62.04|||||TWO_SIDED|90.0|41.92|91.82||||||TFV: Severe Hepatic Impairment Group vs. Matched Normal Hepatic Function Group||91.82|41.92|
72565358|NCT02296853|144662143|EQUIVALENCE|"Sample size calculations were done in Query Advisor 6.0 by using the Two-group t-test of equal means (equal n's) module with α (one-sided) = 0.05, upper equivalence limit = ln(2.0) = 0.691, and expected difference = 0."|GLSM ratio percentage|93.28|||||TWO_SIDED|90.0|72.62|119.8||||||Free (unbound) TAF: Severe Hepatic Impairment Group vs. Matched Normal Hepatic Function Group||119.8|72.62|
72565359|NCT03233958|144662146|OTHER|Due to the single group, pre-post design, the analysis simply investigated the effect of time.|Mean Difference (Final Values)|-0.24|||<|0.001|TWO_SIDED||||||ANOVA|||||||<0.001
72565360|NCT03233958|144662147|OTHER|Due to the single group, pre-post design, the analysis simply investigated the effect of time.|Mean Difference (Final Values)|5.55|||<|0.001|TWO_SIDED||||||ANOVA|||||||<0.001
72565361|NCT03233958|144662148|OTHER|Due to the single group, pre-post design, the analysis simply investigated the effect of time.|Mean Difference (Final Values)|-0.54||||0.002|TWO_SIDED||||||ANOVA|||||||0.002
72565362|NCT03233958|144662149|OTHER|Due to the single group, pre-post design, the analysis simply investigated the effect of time.|Mean Difference (Final Values)|-0.18||||0.076|TWO_SIDED||||||ANOVA|||||||0.076
72565363|NCT03233958|144662150|OTHER|Due to the single group, pre-post design, the analysis simply investigated the effect of time.|Mean Difference (Final Values)|-0.51||||0.147|TWO_SIDED||||||ANOVA|||||||0.147
72565364|NCT03233958|144662151|OTHER|Due to the single group, pre-post design, the analysis simply investigated the effect of time.|Mean Difference (Final Values)|1.07||||0.197|TWO_SIDED||||||ANOVA|||||||0.197
72565365|NCT03233958|144662152|OTHER|Due to the single group, pre-post design, the analysis simply investigated the effect of time.|Mean Difference (Final Values)|1.25|||<|0.001|TWO_SIDED||||||ANOVA|||||||<0.001
72565366|NCT05212883|144662154|OTHER||Odds Ratio (OR)|1.0|||||TWO_SIDED|95.0|0.8|1.3||||||Comparison of the likelihood to test before gathering for age \< 18 vs. age \>= 18.||1.3|0.8|
72565367|NCT02502734|144662166|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority would be demonstrated if the lower limit of the confidence interval (0.025, 1-sided significance test level) for the mean difference in lower-leg growth rate of FF 50 mcg OD versus Placebo was greater than -0.20mm/week.|Mean Difference (Final Values)|-0.052|||||TWO_SIDED|95.0|-0.1217|0.0176||Non-inferiority would be demonstrated if the lower limit of the confidence interval (0.025,1-sided significance test level) for the mean difference in lower-leg growth rate of FF 50 mcg OD versus Placebo was greater than -0.20mm/week.|ANCOVA|Analysis performed using ANCOVA with covariates period-level baseline and subject-level baseline lower-leg length, age, gender, treatment and period.||||0.0176|-0.1217|
72565368|NCT01483625|144662172|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0569|STANDARD_ERROR_OF_MEAN|0.055||0.3025|TWO_SIDED|95.0|-0.0516|0.1654|||Mixed effect repeated measures (MMRM)|Fixed effects:treatment,visit,treatment by visit,baseline and baseline by visit. Random:Patient. A spatial power covariance structure was used.||Tiotropium 18 mcg minus Placebo||0.1654|-0.0516|0.3025
72565369|NCT01483625|144662173|SUPERIORITY_OR_OTHER||Geometric mean ratio|0.99|STANDARD_ERROR_OF_MEAN|0.44||0.7823|TWO_SIDED|95.0|0.9053|1.078|||2sample t quantiles with pooled variance|||Comparison Tiotropium 18 mcg Vs Placebo||1.0780|0.9053|0.7823
72565370|NCT01483625|144662174|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0099|STANDARD_ERROR_OF_MEAN|0.0806||0.9025|TWO_SIDED|95.0|-0.1489|0.1686||Comparison Tiotropium 18 mcg Vs Placebo at Week 12|Mixed effects repeated measures (MMRM)|Fixed effects:treatment,visit,treatment by visit,baseline and baseline by visit. Patient was random. A spatial power covariance structure was used.||||0.1686|-0.1489|0.9025
72565371|NCT01483625|144662177|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.061|STANDARD_ERROR_OF_MEAN|3.0115||0.1797|TWO_SIDED|95.0|-10.0157|1.8938|||t-test, 2 sided|95% confidence interval is based on 2 sample t quantiles using pooled variance.||Comparison Tiotropium 18 mcg Vs Placebo Over 12 Weeks||1.8938|-10.0157|0.1797
72565372|NCT00707447|144662185|SUPERIORITY_OR_OTHER||||||<|0.05||||||There was only one primary outcome variable, thus no adjustments for multiple comparisons were made.|t-test, 2 sided|||independent t-tests for between group comparisons, dependent t-tests for within group comparisons||||<.05
72565373|NCT00707447|144662186|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||independent t-tests for between group comparisons, dependent t-tests for within group comparisons||||<.05
72565374|NCT00707447|144662187|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||||||<.05
72565375|NCT00707447|144662188|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||||||<.05
72565376|NCT00707447|144662189|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||||||<.05
72565377|NCT00707447|144662190|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||||||<.05
72565378|NCT00707447|144662191|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||||||<.05
72565379|NCT00707447|144662192|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||||||<.05
72565380|NCT00707447|144662193|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||||||<.05
72565381|NCT00707447|144662194|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||||||<.05
72565382|NCT03208673|144662204|SUPERIORITY||Ratio of Geometric mean|0.5628||||0.001|TWO_SIDED|95.0|0.4395|0.7204|||t-test, 2 sided|||||0.7204|0.4395|.001
72565383|NCT03208673|144662205|SUPERIORITY|||||||0.025|||||||t-test, 1 sided|||Nasal||||0.025
72565384|NCT03208673|144662205|SUPERIORITY|||||||0.312|||||||t-test, 1 sided|||Temporal||||0.312
72565385|NCT03208673|144662206|SUPERIORITY||||||<|0.001|||||||t-test, 1 sided|||Comfort||||<0.001
72565386|NCT03208673|144662206|SUPERIORITY||||||<|0.001|||||||t-test, 1 sided|||Dry||||<0.001
72565387|NCT03208673|144662206|SUPERIORITY||||||<|0.001|||||||t-test, 1 sided|||Gritty||||<0.001
72565388|NCT03208673|144662206|SUPERIORITY||||||<|0.001|||||||t-test, 1 sided|||Vision||||<0.001
72565389|NCT03891329|144662208|OTHER|No comparison of two groups, just single arm design|SADE-free rate in the study group|0.98||||0.05|TWO_SIDED|95.0|0.9|1.0|||t-test, 2 sided|||"Serious Adverse Device Effects (SADE) possibly or securely related to the Cor Family devices until the 3- month follow-up are counted for this primary endpoint.~The following hypothesis has been defined:~Ho: SADE-free rate through 3 months post-implant ≤ 90.0% Ha: SADE-free rate through 3 months post-implant \> 90.0%"||1|0.9|0.05
72565390|NCT03891329|144662209|OTHER|Kaplan-Meier method|||||||||||||||||The Kaplan-Meier method will be applied to estimate the 3-month SADE-free rate at 92 days after implantation (sensitivity analysis of the primary endpoint) and the 12-month SADE-free rate at 365 days after implantation.|||
72565391|NCT02740179|144662212|SUPERIORITY|||||||0.72||||||P value for Change in Coronary Flow Reserve on Cardiac PET|t-test, 2 sided|||||||0.72
72565392|NCT02740179|144662213|SUPERIORITY|||||||0.03||||||P value for Change in Stress Myocardial Blood Flow on Cardiac MRI|t-test, 2 sided|||||||0.03
72565393|NCT02740179|144662214|SUPERIORITY|||||||0.38|||||||Kruskal-Wallis|||||||0.38
72565394|NCT02740179|144662215|SUPERIORITY|||||||0.09|||||||Kruskal-Wallis|||||||0.09
72565395|NCT02740179|144662216|SUPERIORITY|||||||0.03|||||||t-test, 2 sided|Analyses performed on log transformation of data||||||0.03
72565396|NCT02740179|144662217|SUPERIORITY|||||||0.09||||||P value for Change in Plasma IL-6|t-test, 2 sided|Analyses performed after log transformation of data||||||0.09
72565397|NCT02740179|144662218|SUPERIORITY|||||||0.36||||||P value for Change in Plasma hsCRP|t-test, 2 sided|Analyses performed after log transformation of data||||||0.36
72565398|NCT02740179|144662219|SUPERIORITY|||||||0.88||||||P value for Change in Plasma MCP-1|t-test, 2 sided|Analyses performed after log transformation of data||||||0.88
72565399|NCT02740179|144662220|SUPERIORITY|||||||0.17||||||P value for Change in Plasma sCD163|t-test, 2 sided|Analyses performed after log transformation of data||||||0.17
72565400|NCT02740179|144662221|SUPERIORITY|||||||0.28|||||||t-test, 2 sided|Analyses performed after log transformation of data||||||0.28
72565401|NCT02740179|144662222|SUPERIORITY|||||||0.32|||||||Kruskal-Wallis|||||||0.32
72565402|NCT02740179|144662223|SUPERIORITY|||||||0.003|||||||Kruskal-Wallis|||||||0.003
72565403|NCT02740179|144662224|SUPERIORITY|||||||0.73|||||||Kruskal-Wallis|||||||0.73
72565404|NCT02740179|144662225|SUPERIORITY|||||||0.56|||||||Kruskal-Wallis|||||||0.56
72565405|NCT02740179|144662226|SUPERIORITY|||||||0.03|||||||Kruskal-Wallis|||||||0.03
72565406|NCT02740179|144662227|SUPERIORITY|||||||0.03|||||||t-test, 2 sided|||||||0.03
72622529|NCT03715829|144775122|SUPERIORITY||Least Squares Mean Difference (Net)|-5.1|STANDARD_ERROR_OF_MEAN|6.03||0.2015|TWO_SIDED|90.0|-15.02|4.91||Hochberg's step-up procedure was conducted to compare the ritlecitinib 10 mg QD dose group vs placebo using observed p-values. The familywise Type 1 error rate was controlled at one-sided 0.05. One-sided unadjusted p-value is presented here.|ANCOVA|||||4.91|-15.02|0.2015
72505154|NCT01380093|144541467|SUPERIORITY_OR_OTHER||LS Mean Difference|19.7|||<|0.0001|TWO_SIDED|95.0|14.6|24.8|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||24.8|14.6|<0.0001
72395224|NCT02785354|144297139|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.75||||0.0007|TWO_SIDED|95.0|0.63|0.88|||Fine and Gray model|||Outcome was analyzed during dabigatran or VKA exposure period (on treatment) using: 1) Cumulative function to estimate the incidence (with death as a competing risk), 2) Fine and Gray model to compare the 1-year risk for dabigatran versus VKA, with hazard ratio (HR) and 95%CI (and death as a competing risk).||0.88|0.63|0.0007
72505155|NCT01380093|144541468|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.3||||0.0007|TWO_SIDED|95.0|-3.6|-1.0|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-1.0|-3.6|0.0007
72622530|NCT03253627|144775177|SUPERIORITY|||||||0.46|||||||t-test, 2 sided|||baseline||||0.460
72622531|NCT03253627|144775177|SUPERIORITY|||||||0.896|||||||t-test, 2 sided|||3 months||||0.896
72470524|NCT04092452|144465176|SUPERIORITY||Risk Difference (RD)|-6.8|STANDARD_ERROR_OF_MEAN|10.7||0.7359|TWO_SIDED|90.0|-24.4|10.8||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 8 (Average Pain)||10.8|-24.4|0.7359
72470525|NCT04092452|144465176|SUPERIORITY||Risk Difference (RD)|-16.0|STANDARD_ERROR_OF_MEAN|10.51||0.9291|TWO_SIDED|90.0|-33.3|1.3||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 12 (Average Pain)||1.3|-33.3|0.9291
72470526|NCT04092452|144465176|SUPERIORITY||Risk Difference (RD)|-0.2|STANDARD_ERROR_OF_MEAN|10.44||0.5087|TWO_SIDED|90.0|-17.4|16.9||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 12 (Average Pain)||16.9|-17.4|0.5087
72470527|NCT04092452|144465176|SUPERIORITY||Risk Difference (RD)|-9.5|STANDARD_ERROR_OF_MEAN|10.74||0.8098|TWO_SIDED|90.0|-27.2|8.1||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 12 (Average Pain)||8.1|-27.2|0.8098
72470528|NCT04092452|144465176|SUPERIORITY||Risk Difference (RD)|-8.8|STANDARD_ERROR_OF_MEAN|9.76||0.8114|TWO_SIDED|90.0|-24.8|7.2||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 16 (Average Pain)||7.2|-24.8|0.8114
72470529|NCT04092452|144465176|SUPERIORITY||Risk Difference (RD)|10.8|STANDARD_ERROR_OF_MEAN|10.44||0.1531|TWO_SIDED|90.0|-6.4|28.0||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 16 (Average Pain)||28.0|-6.4|0.1531
72470530|NCT04092452|144465176|SUPERIORITY||Risk Difference (RD)|3.3|STANDARD_ERROR_OF_MEAN|10.58||0.3784|TWO_SIDED|90.0|-14.1|20.7||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 16 (Average Pain)||20.7|-14.1|0.3784
72470531|NCT04092452|144465177|SUPERIORITY||Risk Difference (RD)|-7.44|STANDARD_ERROR_OF_MEAN|6.661||0.1321|TWO_SIDED|90.0|-18.39|3.52||One-sided p-value|ANCOVA|||Week 1 Pain at its Worst||3.52|-18.39|0.1321
72505156|NCT01380093|144541468|SUPERIORITY_OR_OTHER||LS Mean Difference|1.3||||0.0455|TWO_SIDED|95.0|0.0|2.6|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||2.6|0.0|0.0455
72470532|NCT04092452|144465177|SUPERIORITY||Risk Difference (RD)|-10.52|STANDARD_ERROR_OF_MEAN|6.308||0.0477|TWO_SIDED|90.0|-20.9|-0.14||One-sided p-value|ANCOVA|||Week 1 Pain at its Worst||-0.14|-20.90|0.0477
72470533|NCT04092452|144465177|SUPERIORITY||Risk Difference (RD)|-14.13|STANDARD_ERROR_OF_MEAN|6.379||0.0134|TWO_SIDED|90.0|-24.62|-3.63||One-sided p-value|ANCOVA|||Week 1 Pain at its Worst||-3.63|-24.62|0.0134
72470534|NCT04092452|144465177|SUPERIORITY||Risk Difference (RD)|-5.66|STANDARD_ERROR_OF_MEAN|8.38||0.2496|TWO_SIDED|90.0|-19.45|8.12||One-sided p-value|ANCOVA|||Week 2 Pain at its Worst||8.12|-19.45|0.2496
72470535|NCT04092452|144465177|SUPERIORITY||Risk Difference (RD)|-11.92|STANDARD_ERROR_OF_MEAN|7.972||0.0675|TWO_SIDED|90.0|-25.03|1.2||One-sided p-value|ANCOVA|||Week 2 Pain at its Worst||1.20|-25.03|0.0675
72470536|NCT04092452|144465177|SUPERIORITY||Risk Difference (RD)|-11.71|STANDARD_ERROR_OF_MEAN|8.054||0.073|TWO_SIDED|90.0|-24.96|1.54||One-sided p-value|ANCOVA|||Week 2 Pain at its Worst||1.54|-24.96|0.0730
72470537|NCT04092452|144465177|SUPERIORITY||Risk Difference (RD)|3.25|STANDARD_ERROR_OF_MEAN|8.892||0.6426|TWO_SIDED|90.0|-11.38|17.88||One-sided p-value|ANCOVA|||Week 4 Pain at its Worst||17.88|-11.38|0.6426
72565407|NCT02377921|144662252|SUPERIORITY||Least Squares (LS) Mean Difference|0.74||||0.5387|TWO_SIDED|95.0|-1.61|3.09||Generalized estimating equation (GEE) model includes change from Baseline (BL) as dependent variable, visit, treatment and visit by treatment as fixed factors, and BL values, sex, and region as covariates, with compound symmetry covariance structure.|GEE model||Difference = Ace-ER - placebo|||3.09|-1.61|0.5387
72565408|NCT02377921|144662253|SUPERIORITY||LS Mean Difference|-0.4||||0.6938|TWO_SIDED|95.0|-2.38|1.58||GEE model includes change from Baseline as dependent variable, visit, treatment and visit by treatment as fixed factors, and Baseline values, sex, and region as covariates, with compound symmetry covariance structure.|GEE model||Difference = Ace-ER - placebo|||1.58|-2.38|0.6938
72470538|NCT04092452|144465177|SUPERIORITY||Risk Difference (RD)|-7.82|STANDARD_ERROR_OF_MEAN|8.457||0.1776|TWO_SIDED|90.0|-21.73|6.09||One-sided p-value|ANCOVA|||Week 4 Pain at its Worst||6.09|-21.73|0.1776
72505157|NCT01380093|144541468|SUPERIORITY_OR_OTHER||LS Mean Difference|3.6|||<|0.0001|TWO_SIDED|95.0|2.3|4.9|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||4.9|2.3|<0.0001
72565409|NCT02377921|144662254|SUPERIORITY||LS Mean Difference|-1.49||||0.5023|TWO_SIDED|95.0|-5.83|2.86||GEE model includes change from Baseline as dependent variable, visit, treatment and visit by treatment as fixed factors, and Baseline values, sex, and region as covariates, with compound symmetry covariance structure.|GEE model||Difference = Ace-ER - placebo|||2.86|-5.83|0.5023
72565410|NCT02377921|144662255|SUPERIORITY||LS Mean Difference|-0.72||||0.2739|TWO_SIDED|95.0|-2.01|0.57||GEE model includes change from Baseline as dependent variable, visit, treatment and visit by treatment as fixed factors, and Baseline values, sex, and region as covariates, with compound symmetry covariance structure.|GEE model||Difference = Ace-ER - placebo|||0.57|-2.01|0.2739
72565411|NCT02377921|144662256|SUPERIORITY||LS Mean Difference|-2.76||||0.1235|TWO_SIDED|95.0|-6.27|0.75||GEE model includes change from Baseline as dependent variable, visit, treatment and visit by treatment as fixed factors, and Baseline values, sex, and region as covariates, with compound symmetry covariance structure.|GEE model||Difference: Ace-ER 6 g/day - placebo|||0.75|-6.27|0.1235
72565412|NCT02377921|144662257|SUPERIORITY||LS Mean Difference|-0.43||||0.3907|TWO_SIDED|95.0|-1.4|0.55||GEE model includes change from Baseline as dependent variable, visit, treatment and visit by treatment as fixed factors, and Baseline values, sex, and region as covariates, with compound symmetry covariance structure.|GEE model||Difference: Ace-ER 6 g/day - placebo|||0.55|-1.40|0.3907
72565413|NCT02377921|144662258|OTHER||LS Mean Difference|-10.98||||0.1964|TWO_SIDED|95.0|-27.64|5.68||GEE model includes change from Baseline as dependent variable, visit, treatment and visit by treatment as fixed factors, and Baseline values, sex, and region as covariates, with compound symmetry covariance structure.|GEE model||Difference: Ace-ER 6 g/day - placebo|||5.68|-27.64|0.1964
72565414|NCT02377921|144662259|SUPERIORITY||LS Mean Difference|-1.4||||0.2241|TWO_SIDED|95.0|-3.66|0.86||GEE model includes change from Baseline as dependent variable, visit, treatment and visit by treatment as fixed factors, and Baseline values, sex, and region as covariates, with compound symmetry covariance structure.|GEE model||Difference: Ace-ER - placebo|||0.86|-3.66|0.2241
72565415|NCT02377921|144662260|OTHER||LS Mean Difference|-0.32||||0.5608|TWO_SIDED|95.0|-1.39|0.75||GEE model includes change from Baseline as dependent variable, visit, treatment and visit by treatment as fixed factors, and Baseline values, sex, and region as covariates, with compound symmetry covariance structure.|GEE model||Difference: Ace-ER 6 g/day - placebo|||0.75|-1.39|0.5608
72565416|NCT04184999|144662268|SUPERIORITY||F-Statistic|207.4|||<|0.01|TWO_SIDED||||||ANOVA|||||||<.01
72565417|NCT00545688|144662269|SUPERIORITY_OR_OTHER||Difference in Response rates|16.82||||0.0094|TWO_SIDED|95.0|3.5|30.1||Cochran-Mantel-Haenszel test stratified by breast cancer type (operable, locally advanced, or inflammatory) and estrogen and or progesterone positivity (either positive versus both negative).|Cochran-Mantel-Haenszel|||||30.1|3.5|0.0094
72470539|NCT04092452|144465177|SUPERIORITY||Risk Difference (RD)|-1.17|STANDARD_ERROR_OF_MEAN|8.579||0.4458|TWO_SIDED|90.0|-15.28|12.94||One-sided p-value|ANCOVA|||Week 4 Pain at its Worst||12.94|-15.28|0.4458
72565418|NCT00545688|144662269|SUPERIORITY_OR_OTHER|||||||0.0141|TWO_SIDED|||||P-value from Cochran-Mantel-Haenszel test, with Simes multiplicity adjustment.|Cochran-Mantel-Haenszel|||||||0.0141
72565419|NCT00545688|144662269|SUPERIORITY_OR_OTHER||Difference in Response rates|-12.15||||0.0198|TWO_SIDED|95.0|-23.8|-0.5||Cochran-Mantel-Haenszel test stratified by breast cancer type (operable, locally advanced, or inflammatory) and estrogen and or progesterone positivity (either positive versus both negative).|Cochran-Mantel-Haenszel|||||-0.5|-23.8|0.0198
72565420|NCT00545688|144662269|SUPERIORITY_OR_OTHER|||||||0.0198|TWO_SIDED|||||P-value from Cochran-Mantel-Haenszel test, with Simes multiplicity adjustment.|Cochran-Mantel-Haenszel|||||||0.0198
72565421|NCT00545688|144662269|SUPERIORITY_OR_OTHER||Difference in Response rates|-21.84||||0.001|TWO_SIDED|95.0|-35.1|-8.5||Cochran-Mantel-Haenszel test stratified by breast cancer type (operable, locally advanced, or inflammatory) and estrogen and or progesterone positivity (either positive versus both negative).|Cochran-Mantel-Haenszel|||||-8.5|-35.1|0.0010
72565422|NCT00545688|144662269|SUPERIORITY_OR_OTHER|||||||0.003|TWO_SIDED|||||P-value from Cochran-Mantel-Haenszel test, with Simes multiplicity adjustment.|Cochran-Mantel-Haenszel|||||||0.0030
72565423|NCT00545688|144662284|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.69||||0.2983|TWO_SIDED|95.0|0.34|1.4|||Cochran-Mantel-Haenszel||HR is based on Cox proportional hazard regression stratified by breast cancer type and hormone positivity.|PFS||1.40|0.34|0.2983
72565424|NCT00545688|144662284|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.25||||0.4722|TWO_SIDED|95.0|0.68|2.3|||Cochran-Mantel-Haenszel||HR is based on Cox proportional hazard regression stratified by breast cancer type and hormone positivity.|PFS||2.30|0.68|0.4722
72565425|NCT00545688|144662284|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.05||||0.0268|TWO_SIDED|95.0|1.07|3.93|||Cochran-Mantel-Haenszel||HR is based on Cox proportional hazard regression stratified by breast cancer type and hormone positivity.|PFS||3.93|1.07|0.0268
72565426|NCT00545688|144662284|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.6||||0.1805|TWO_SIDED|95.0|0.28|1.27|||Cochran-Mantel-Haenszel||HR is based on Cox proportional hazard regression stratified by breast cancer type and hormone positivity.|DFS||1.27|0.28|0.1805
72565427|NCT00545688|144662284|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.83||||0.5901|TWO_SIDED|95.0|0.42|1.64|||Cochran-Mantel-Haenszel||HR is based on Cox proportional hazard regression stratified by breast cancer type and hormone positivity.|DFS||1.64|0.42|0.5901
72565428|NCT00545688|144662284|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.16||||0.025|TWO_SIDED|95.0|1.08|4.32|||Cochran-Mantel-Haenszel||HR is based on Cox proportional hazard regression stratified by breast cancer type and hormone positivity.|DFS||4.32|1.08|0.0250
72565429|NCT01117337|144662347|SUPERIORITY_OR_OTHER|||||||0.2||95.0|||||Fisher Exact|||||||0.2
72565430|NCT01117337|144662348|SUPERIORITY_OR_OTHER|||||||0.56||95.0|||||Fisher Exact|||||||0.56
72565431|NCT03575871|144662349|SUPERIORITY||Difference in Percentage|19.3||||0.0008|TWO_SIDED|95.0|9.6|29.0||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||The estimate and confidence interval (CI) for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||29.0|9.6|0.0008
72565432|NCT03575871|144662349|SUPERIORITY||Difference in Percentage|28.7|||<|0.0001|TWO_SIDED|95.0|18.6|38.8||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||38.8|18.6|<0.0001
72622532|NCT03253627|144775178|SUPERIORITY|||||||0.374|||||||t-test, 2 sided|||baseline||||0.374
72622533|NCT03253627|144775178|SUPERIORITY|||||||0.236|||||||t-test, 2 sided|||6 months||||0.236
72622534|NCT03253627|144775179|SUPERIORITY|||||||0.18|||||||t-test, 2 sided|||baseline||||0.180
72622535|NCT03253627|144775179|SUPERIORITY|||||||0.822|||||||t-test, 2 sided|||6 months||||0.822
72622536|NCT03253627|144775180|SUPERIORITY|||||||0.715|||||||t-test, 2 sided|||baseline||||.715
72622537|NCT03253627|144775180|SUPERIORITY|||||||0.861|||||||t-test, 2 sided|||3 months||||0.861
72622538|NCT03253627|144775180|SUPERIORITY|||||||0.79|||||||t-test, 2 sided|||6 months||||.790
72622539|NCT03253627|144775181|SUPERIORITY|||||||0.452|||||||t-test, 2 sided|||baseline||||0.452
72622540|NCT03253627|144775181|SUPERIORITY|||||||0.253|||||||t-test, 2 sided|||3 months||||0.253
72622541|NCT03253627|144775181|SUPERIORITY|||||||0.469|||||||t-test, 2 sided|||6 months||||0.469
72622542|NCT03253627|144775182|SUPERIORITY|||||||0.628|||||||t-test, 2 sided|||baseline||||0.628
72622543|NCT03253627|144775182|SUPERIORITY|||||||0.345|||||||t-test, 2 sided|||3 months||||0.345
72395225|NCT02785354|144297139|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.98||||0.8341|TWO_SIDED|95.0|0.85|1.14|||Fine and Gray model|||Outcome was analyzed during rivaroxaban or VKA exposure period (on treatment) using: 1) Cumulative function to estimate the incidence (with death as a competing risk), 2) Fine and Gray model to compare the 1-year risk for rivaroxaban versus VKA, with HR and 95%CI (and death as a competing risk).||1.14|0.85|0.8341
72622544|NCT03253627|144775182|SUPERIORITY|||||||0.384|||||||t-test, 2 sided|||6 months||||0.384
72622545|NCT03253627|144775183|SUPERIORITY|||||||0.398|||||||t-test, 2 sided|||baseline||||.398
72622546|NCT03253627|144775183|SUPERIORITY|||||||0.811|||||||t-test, 2 sided|||3 months||||0.811
72622547|NCT03253627|144775183|SUPERIORITY|||||||0.027|||||||t-test, 2 sided|||6 months||||0.027
72622548|NCT01813357|144775194|SUPERIORITY||Mean Difference (Final Values)|0.002||||0.684|TWO_SIDED||||||Mixed Models Analysis|||||||0.684
72470540|NCT04092452|144465177|SUPERIORITY||Risk Difference (RD)|7.94|STANDARD_ERROR_OF_MEAN|9.566||0.7969|TWO_SIDED|90.0|-7.79|23.68||One-sided p-value|ANCOVA|||Week 6 Pain at its Worst||23.68|-7.79|0.7969
72470541|NCT04092452|144465177|SUPERIORITY||Risk Difference (RD)|-11.09|STANDARD_ERROR_OF_MEAN|9.12||0.112|TWO_SIDED|90.0|-26.09|3.91||One-sided p-value|ANCOVA|||Week 6 Pain at its Worst||3.91|-26.09|0.1120
72470542|NCT04092452|144465177|SUPERIORITY||Risk Difference (RD)|0.05|STANDARD_ERROR_OF_MEAN|9.188||0.5021|TWO_SIDED|90.0|-15.06|15.16||One-sided p-value|ANCOVA|||Week 6 Pain at its Worst||15.16|-15.06|0.5021
72622549|NCT03773562|144775196|SUPERIORITY|||||||0.04|||||||t-test, 2 sided|||Responders vs Non-responders||||0.04
72622550|NCT03773562|144775198|SUPERIORITY|||||||0.002|||||||t-test, 2 sided|||Responders vs Non-Responders||||0.002
72622551|NCT03773562|144775199|SUPERIORITY|||||||0.01|||||||t-test, 2 sided|||Responders vs Non-responders||||0.01
72622552|NCT03773562|144775201|SUPERIORITY|||||||0.0003|||||||t-test, 2 sided|||Responder vs non-responder||||0.0003
72622553|NCT03773562|144775202|SUPERIORITY|||||||0.0003|||||||t-test, 2 sided|||Responder vs non-responder||||0.0003
72622554|NCT03773562|144775203|SUPERIORITY|||||||0.0003|||||||t-test, 2 sided|||Responder vs non-responder||||0.0003
72622555|NCT03773562|144775204|SUPERIORITY|||||||0.0033|||||||t-test, 2 sided|||Responder vs non-responder||||0.0033
72622556|NCT03773562|144775205|SUPERIORITY|||||||0.0041|||||||t-test, 2 sided|||Responder vs non-responder||||0.0041
72622557|NCT03773562|144775206|SUPERIORITY|||||||0.0046|||||||t-test, 2 sided|||Responder vs non-responder||||0.0046
72622558|NCT01111552|144775219|SUPERIORITY||Treatment Difference|-1.3|||=|0.595|TWO_SIDED|95.0|-5.9|3.4|||ANCOVA|||||3.4|-5.9|=0.595
72622559|NCT01111552|144775219|SUPERIORITY||Treatment Difference|0.4|||=|0.869|TWO_SIDED|95.0|-4.4|5.1|||ANCOVA|||||5.1|-4.4|=0.869
72622560|NCT01111552|144775220|SUPERIORITY||Treatment Difference|-0.1|||=|0.856|TWO_SIDED|95.0|-0.7|0.6|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel Row Mean Scores Test was used to determine the p-value.||||0.6|-0.7|=0.856
72622561|NCT01111552|144775220|SUPERIORITY||Treatment Difference|0.1|||=|0.838|TWO_SIDED|95.0|-0.6|0.7|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel Row Mean Scores Test was used to determine the p-value.||||0.7|-0.6|=0.838
72622562|NCT01111552|144775221|SUPERIORITY||Treatment Difference|-0.2|||=|0.765|TWO_SIDED|95.0|-1.6|1.2|||ANCOVA|||||1.2|-1.6|=0.765
72622563|NCT01111552|144775221|SUPERIORITY||Treatment Difference|0.2|||=|0.76|TWO_SIDED|95.0|-1.2|1.6|||ANCOVA|||||1.6|-1.2|=0.760
72622564|NCT01852214|144775262|SUPERIORITY_OR_OTHER|||||||0.022|||||||Mixed Models Analysis|||||||0.022
72622565|NCT01852214|144775263|SUPERIORITY_OR_OTHER|||||||0.086|||||||Mixed Models Analysis|||||||0.086
72622566|NCT00373360|144775290|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Wilcoxon signed rank test|||Change between Baseline and Week 8||||1.000
72622567|NCT00373360|144775291|SUPERIORITY_OR_OTHER|||||||0.008||95.0|||||Wilcoxon signed rank test|||Change between Baseline and Week 8||||0.008
72622568|NCT00373360|144775292|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Wilcoxon signed rank test|||Change between Baseline and Week 8||||1.000
72622569|NCT00373360|144775293|SUPERIORITY_OR_OTHER|||||||0.531||95.0|||||Wilcoxon signed rank test|||Change between Baseline and Week 8||||0.531
72622570|NCT00373360|144775294|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Wilcoxon signed rank test|||Change between Baseline and Week 8||||1.000
72622571|NCT00373360|144775295|SUPERIORITY_OR_OTHER|||||||0.5||95.0|||||Wilcoxon signed rank test|||Change between Baseline and Week 8||||0.500
72622572|NCT00373360|144775296|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Wilcoxon signed rank test|||Change between Baseline and Week 8||||1.000
72622573|NCT00373360|144775297|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Wilcoxon signed rank test|||Change from Baseline to Week 8||||1.000
72622574|NCT00373360|144775298|SUPERIORITY_OR_OTHER|||||||0||95.0|||||Wilcoxon signed rank test|||Change between Baseline and Week 8||||0
72622575|NCT00373360|144775299|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Wilcoxon signed rank test|||Change between Baseline and Week 8||||1.000
72622576|NCT00373360|144775300|SUPERIORITY_OR_OTHER|||||||0.031||95.0|||||Wilcoxon signed rank test|||Change between Baseline and Week 8||||0.031
72622577|NCT00373360|144775301|SUPERIORITY_OR_OTHER|||||||0.031||95.0|||||Wilcoxon signed rank test|||Change between Baseline and Week 8||||0.031
72622578|NCT00373360|144775302|SUPERIORITY_OR_OTHER|||||||0.004||95.0|||||Wilcoxon signed rank test|||Change between Baseline and Week 8||||0.004
72395226|NCT02785354|144297140|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.79||||0.0147|TWO_SIDED|95.0|0.65|0.95|||Fine and Gray model|||Outcome was analyzed during dabigatran or VKA exposure period (on treatment) using: 1) Cumulative function to estimate the incidence (with death as a competing risk), 2) Fine and Gray model to compare the 1-year risk for dabigatran versus VKA, with hazard ratio (HR) and 95%CI (and death as a competing risk).||0.95|0.65|0.0147
72395227|NCT02785354|144297140|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.84||||0.0501|TWO_SIDED|95.0|0.71|1.0|||Fine and Gray model|||Outcome was analyzed during rivaroxaban or VKA exposure period (on treatment) using: 1) Cumulative function to estimate the incidence (with death as a competing risk), 2) Fine and Gray model to compare the 1-year risk for rivaroxaban versus VKA, with HR and 95%CI (and death as a competing risk).||1.00|0.71|0.0501
72470543|NCT04092452|144465177|SUPERIORITY||Risk Difference (RD)|2.83|STANDARD_ERROR_OF_MEAN|9.296||0.6197|TWO_SIDED|90.0|-12.46|18.12||One-sided p-value|ANCOVA|||Week 8 Pain at its Worst||18.12|-12.46|0.6197
72565433|NCT03575871|144662350|SUPERIORITY||Difference in Percentage|33.9|||<|0.0001|TWO_SIDED|95.0|23.3|44.4||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||44.4|23.3|<0.0001
72470544|NCT04092452|144465177|SUPERIORITY||Risk Difference (RD)|-11.3|STANDARD_ERROR_OF_MEAN|8.825||0.1003|TWO_SIDED|90.0|-25.81|3.22||One-sided p-value|ANCOVA|||Week 8 Pain at its Worst||3.22|-25.81|0.1003
72470545|NCT04092452|144465177|SUPERIORITY||Risk Difference (RD)|0.16|STANDARD_ERROR_OF_MEAN|8.908||0.507|TWO_SIDED|90.0|-14.5|14.81||One-sided p-value|ANCOVA|||Week 8 Pain at its Worst||14.81|-14.50|0.5070
72470546|NCT04092452|144465177|SUPERIORITY||Risk Difference (RD)|0.67|STANDARD_ERROR_OF_MEAN|9.368||0.5283|TWO_SIDED|90.0|-14.74|16.08||One-sided p-value|ANCOVA|||Week 12 Pain at its Worst||16.08|-14.74|0.5283
72470547|NCT04092452|144465177|SUPERIORITY||Risk Difference (RD)|-15.31|STANDARD_ERROR_OF_MEAN|8.921||0.0431|TWO_SIDED|90.0|-29.98|-0.63||One-sided p-value|ANCOVA|||Week 12 Pain at its Worst||-0.63|-29.98|0.0431
72470548|NCT04092452|144465177|SUPERIORITY||Risk Difference (RD)|-6.39|STANDARD_ERROR_OF_MEAN|9.02||0.2395|TWO_SIDED|90.0|-21.22|8.45||One-sided p-value|ANCOVA|||Week 12 Pain at its Worst||8.45|-21.22|0.2395
72470549|NCT04092452|144465177|SUPERIORITY||Risk Difference (RD)|2.57|STANDARD_ERROR_OF_MEAN|9.617||0.6054|TWO_SIDED|90.0|-13.25|18.39||One-sided p-value|ANCOVA|||Week 16 Pain at its Worst||18.39|-13.25|0.6054
72470550|NCT04092452|144465177|SUPERIORITY||Risk Difference (RD)|-21.54|STANDARD_ERROR_OF_MEAN|9.344||0.0106|TWO_SIDED|90.0|-36.91|-6.17||One-sided p-value|ANCOVA|||Week 16 Pain at its Worst||-6.17|-36.91|0.0106
72470551|NCT04092452|144465177|SUPERIORITY||Risk Difference (RD)|-12.54|STANDARD_ERROR_OF_MEAN|9.305||0.089|TWO_SIDED|90.0|-27.84|2.77||One-sided p-value|ANCOVA|||Week 16 Pain at its Worst||2.77|-27.84|0.0890
72470552|NCT04092452|144465178|SUPERIORITY||Risk Difference (RD)|-6.17|STANDARD_ERROR_OF_MEAN|5.963||0.1505|TWO_SIDED|90.0|-15.98|3.64||One-sided p-value|ANCOVA|||Week 1 Average Pain||3.64|-15.98|0.1505
72470553|NCT04092452|144465178|SUPERIORITY||Risk Difference (RD)|-11.06|STANDARD_ERROR_OF_MEAN|5.555||0.0233|TWO_SIDED|90.0|-20.19|-1.92||One-sided p-value|ANCOVA|||Week 1 Average Pain||-1.92|-20.19|0.0233
72565434|NCT03575871|144662350|SUPERIORITY||Difference in Percentage|50.5|||<|0.0001|TWO_SIDED|95.0|40.0|60.9||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||60.9|40.0|<0.0001
72622579|NCT00373360|144775303|SUPERIORITY_OR_OTHER|||||||0.063||95.0|||||Wilcoxon signed rank test|||Change between Baseline and Week 8||||0.063
72470554|NCT04092452|144465178|SUPERIORITY||Risk Difference (RD)|-6.34|STANDARD_ERROR_OF_MEAN|5.926||0.1423|TWO_SIDED|90.0|-16.09|3.41||One-sided p-value|ANCOVA|||Week 1 Average Pain||3.41|-16.09|0.1423
72470555|NCT04092452|144465178|SUPERIORITY||Risk Difference (RD)|-2.15|STANDARD_ERROR_OF_MEAN|7.202||0.3827|TWO_SIDED|90.0|-14.0|9.7||One-sided p-value|ANCOVA|||Week 2 Average Pain||9.70|-14.00|0.3827
72470556|NCT04092452|144465178|SUPERIORITY||Risk Difference (RD)|-10.35|STANDARD_ERROR_OF_MEAN|6.741||0.0624|TWO_SIDED|90.0|-21.44|0.74||One-sided p-value|ANCOVA|||Week 2 Average Pain||0.74|-21.44|0.0624
72470557|NCT04092452|144465178|SUPERIORITY||Risk Difference (RD)|-2.25|STANDARD_ERROR_OF_MEAN|7.171||0.3771|TWO_SIDED|90.0|-14.04|9.55||One-sided p-value|ANCOVA|||Week 2 Average Pain||9.55|-14.04|0.3771
72470558|NCT04092452|144465178|SUPERIORITY||Risk Difference (RD)|8.04|STANDARD_ERROR_OF_MEAN|8.614||0.8247|TWO_SIDED|90.0|-6.13|22.21||One-sided p-value|ANCOVA|||Week 4 Average Pain||22.21|-6.13|0.8247
72470559|NCT04092452|144465178|SUPERIORITY||Risk Difference (RD)|-8.97|STANDARD_ERROR_OF_MEAN|8.09||0.1337|TWO_SIDED|90.0|-22.28|4.33||One-sided p-value|ANCOVA|||Week 4 Average Pain||4.33|-22.28|0.1337
72470560|NCT04092452|144465178|SUPERIORITY||Risk Difference (RD)|5.37|STANDARD_ERROR_OF_MEAN|8.523||0.7357|TWO_SIDED|90.0|-8.65|19.39||One-sided p-value|ANCOVA|||Week 4 Average Pain||19.39|-8.65|0.7357
72470561|NCT04092452|144465178|SUPERIORITY||Risk Difference (RD)|13.78|STANDARD_ERROR_OF_MEAN|8.977||0.9377|TWO_SIDED|90.0|-0.98|28.55||One-sided p-value|ANCOVA|||Week 6 Average Pain||28.55|-0.98|0.9377
72470562|NCT04092452|144465178|SUPERIORITY||Risk Difference (RD)|-9.39|STANDARD_ERROR_OF_MEAN|8.45||0.1332|TWO_SIDED|90.0|-23.29|4.51||One-sided p-value|ANCOVA|||Week 6 Average Pain||4.51|-23.29|0.1332
72470563|NCT04092452|144465178|SUPERIORITY||Risk Difference (RD)|6.05|STANDARD_ERROR_OF_MEAN|8.907||0.7514|TWO_SIDED|90.0|-8.6|20.7||One-sided p-value|ANCOVA|||Week 6 Average Pain||20.70|-8.60|0.7514
72470564|NCT04092452|144465178|SUPERIORITY||Risk Difference (RD)|8.97|STANDARD_ERROR_OF_MEAN|8.902||0.8433|TWO_SIDED|90.0|-5.67|23.62||One-sided p-value|ANCOVA|||Week 8 Average Pain||23.62|-5.67|0.8433
72470565|NCT04092452|144465178|SUPERIORITY||Risk Difference (RD)|-8.84|STANDARD_ERROR_OF_MEAN|8.392||0.1461|TWO_SIDED|90.0|-22.64|4.96||One-sided p-value|ANCOVA|||Week 8 Average Pain||4.96|-22.64|0.1461
72470566|NCT04092452|144465178|SUPERIORITY||Risk Difference (RD)|8.64|STANDARD_ERROR_OF_MEAN|8.818||0.8364|TWO_SIDED|90.0|-5.86|23.15||One-sided p-value|ANCOVA|||Week 8 Average Pain||23.15|-5.86|0.8364
72470567|NCT04092452|144465178|SUPERIORITY||Risk Difference (RD)|2.35|STANDARD_ERROR_OF_MEAN|8.527||0.6085|TWO_SIDED|90.0|-11.68|16.37||One-sided p-value|ANCOVA|||Week 12 Average Pain||16.37|-11.68|0.6085
72395228|NCT02785354|144297141|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.74|||<|0.0001|TWO_SIDED|95.0|0.67|0.82|||Cox proportional hazard risk model|||Outcome was analyzed during dabigatran or VKA exposure period (on treatment) using: 1) Kaplan-Meier to estimate the cumulative incidence, 2) Cox proportional hazard risk model to compare the 1-year risk for dabigatran versus VKA, with HR and 95%CI.||0.82|0.67|<0.0001
72565435|NCT03575871|144662351|SUPERIORITY||Difference in Percentage|19.2||||0.0002|TWO_SIDED|95.0|11.0|27.4||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||27.4|11.0|0.0002
72565436|NCT03575871|144662351|SUPERIORITY||Difference in Percentage|31.2|||<|0.0001|TWO_SIDED|95.0|22.3|40.2||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||40.2|22.3|<0.0001
72565437|NCT03575871|144662351|SUPERIORITY||Difference in Percentage|27.5|||<|0.0001|TWO_SIDED|95.0|18.9|36.2||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||36.2|18.9|<0.0001
72565438|NCT03575871|144662351|SUPERIORITY||Difference in Percentage|46.4|||<|0.0001|TWO_SIDED|95.0|37.2|55.7||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||55.7|37.2|<0.0001
72565439|NCT03575871|144662351|SUPERIORITY||Difference in Percentage|27.4|||<|0.0001|TWO_SIDED|95.0|16.8|38.0||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||38.0|16.8|<0.0001
72622580|NCT00373360|144775304|SUPERIORITY_OR_OTHER|||||||0.203||95.0|||||Wilcoxon signed rank test|||Change Between Baseline and Week 8||||0.203
72395229|NCT02785354|144297141|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.77|||<|0.0001|TWO_SIDED|95.0|0.71|0.84|||Cox proportional hazard risk model|||Outcome was analyzed during rivaroxaban or VKA exposure period (on treatment) using: 1) Kaplan-Meier to estimate the cumulative incidence, 2) Cox proportional hazard risk model to compare the 1-year risk for rivaroxaban versus VKA, with HR and 95%CI.||0.84|0.71|<0.0001
72395230|NCT02785354|144297142|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.71|||<|0.0001|TWO_SIDED|95.0|0.66|0.76|||Cox proportional hazard risk model|||Outcome was analyzed during dabigatran or VKA exposure period (on treatment) using: 1) Kaplan-Meier to estimate the cumulative incidence, 2) Cox proportional hazard risk model to compare the 1-year risk for dabigatran versus VKA, with HR and 95%CI.||0.76|0.66|<0.0001
72622581|NCT00373360|144775308|SUPERIORITY_OR_OTHER|||||||0.25||95.0|||||Wilcoxon signed rank test|||Change from Baseline to Week 8||||0.250
72470568|NCT04092452|144465178|SUPERIORITY||Risk Difference (RD)|-14.38|STANDARD_ERROR_OF_MEAN|8.022||0.0365|TWO_SIDED|90.0|-27.58|-1.19||One-sided p-value|ANCOVA|||Week 12 Average Pain||-1.19|-27.58|0.0365
72565440|NCT03575871|144662351|SUPERIORITY||Difference in Percentage|39.8|||<|0.0001|TWO_SIDED|95.0|28.9|50.6||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||50.6|28.9|<0.0001
72565441|NCT03575871|144662351|SUPERIORITY||Difference in Percentage|29.3|||<|0.0001|TWO_SIDED|95.0|18.9|39.6||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||39.6|18.9|<0.0001
72565442|NCT03575871|144662351|SUPERIORITY||Difference in Percentage|38.6|||<|0.0001|TWO_SIDED|95.0|28.1|49.1||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||49.1|28.1|<0.0001
72622582|NCT00373360|144775309|SUPERIORITY_OR_OTHER|||||||0.207||95.0|||||Wilcoxon signed rank test|||Change between Baseline and Week 8||||0.207
72622583|NCT00373360|144775310|SUPERIORITY_OR_OTHER|||||||0.297||95.0|||||Wilcoxon signed rank test|||Change between Baseline and Week 8||||0.297
72565443|NCT03575871|144662352|SUPERIORITY||Difference in LS mean|-1.7|||<|0.0001|TWO_SIDED|95.0|-2.3|-1.1|||Mixed Models Analysis|||Mixed Model Repeated Measure (MMRM) contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category), baseline value and an unstructured covariance matrix.||-1.1|-2.3|<0.0001
72622584|NCT00373360|144775311|SUPERIORITY_OR_OTHER|||||||0.004||95.0|||||Wilcoxon signed rank test|||Change between Baseline and Week 8||||0.004
72622585|NCT02414841|144775328|SUPERIORITY||Hazard Ratio (HR)|0.96||||0.932|TWO_SIDED|95.0|0.67|1.39|||Log Rank|Weighted|Performed as sensitivity analysis|||1.39|0.67|0.932
72622586|NCT02414841|144775329|SUPERIORITY|||||||0.328|||||||Chi-squared|||||||0.328
72395231|NCT02785354|144297142|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.84|||<|0.0001|TWO_SIDED|95.0|0.79|0.89|||Cox proportional hazard risk model|||Outcome was analyzed during rivaroxaban or VKA exposure period (on treatment) using: 1) Kaplan-Meier to estimate the cumulative incidence, 2) Cox proportional hazard risk model to compare the 1-year risk for rivaroxaban versus VKA, with HR and 95%CI.||0.89|0.79|<0.0001
72470569|NCT04092452|144465178|SUPERIORITY||Risk Difference (RD)|0.43|STANDARD_ERROR_OF_MEAN|8.469||0.5201|TWO_SIDED|90.0|-13.5|14.36||One-sided p-value|ANCOVA|||Week 12 Average Pain||14.36|-13.50|0.5201
72622587|NCT05339659|144775338|OTHER|The point null hypothesis of the significance test was a difference in expected number of log ins of 0.|Mean Difference (Final Values)|3.55||||0.219|TWO_SIDED|95.0|-2.33|9.44|||Regression, Linear||mean difference=experimental-control|A priori power calculations estimated detectable differences with 80% power with type 1 error rate=0.05, assuming a two-sided unequal variance t-test (standard deviations of 2.0 and 7.0 in the control and experimental arms, respectively) and a total sample of n=50 equally split between arms. Given a final sample size of 19 (7 control, 12 experimental), we re-calculated the detectable mean difference with these sample sizes (maintaining all other original assumptions), which is 6.51 sessions.||9.44|-2.33|0.219
72565444|NCT03575871|144662352|SUPERIORITY||Difference in LS mean|-2.2|||<|0.0001|TWO_SIDED|95.0|-2.8|-1.6|||Mixed Models Analysis|||Mixed Model Repeated Measure (MMRM) contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category), baseline value and an unstructured covariance matrix.||-1.6|-2.8|<0.0001
72565445|NCT03575871|144662354|SUPERIORITY||Difference in Percentage|8.8||||0.015|TWO_SIDED|95.0|2.8|14.9||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||14.9|2.8|0.0150
72565446|NCT03575871|144662354|SUPERIORITY||Difference in Percentage|22.7|||<|0.0001|TWO_SIDED|95.0|15.0|30.3||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||30.3|15.0|<0.0001
72565447|NCT03575871|144662354|SUPERIORITY||Difference in Percentage|20.0||||0.0004|TWO_SIDED|95.0|10.9|29.0||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||29.0|10.9|0.0004
72565448|NCT03575871|144662354|SUPERIORITY||Difference in Percentage|44.3|||<|0.0001|TWO_SIDED|95.0|34.8|53.8||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||53.8|34.8|<0.0001
72565449|NCT03575871|144662354|SUPERIORITY||Difference in Percentage|30.4|||<|0.0001|TWO_SIDED|95.0|19.7|41.2||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||41.2|19.7|<0.0001
72565450|NCT03575871|144662354|SUPERIORITY||Difference in Percentage|47.4|||<|0.0001|TWO_SIDED|95.0|36.8|58.0||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||58.0|36.8|<0.0001
72622588|NCT05339659|144775340|OTHER|The null hypothesis for the significance test is 0 difference in average number of days of use between arms.|Mean Difference (Final Values)|-22.12||||0.153|TWO_SIDED|95.0|-53.44|9.19|||Regression, Linear||mean difference=experimental-control|||9.19|-53.44|0.153
72470570|NCT04092452|144465178|SUPERIORITY||Risk Difference (RD)|4.04|STANDARD_ERROR_OF_MEAN|8.564||0.6813|TWO_SIDED|90.0|-10.05|18.12||One-sided p-value|ANCOVA|||Week 16 Average Pain||18.12|-10.05|0.6813
72565451|NCT03575871|144662355|SUPERIORITY||Difference in Percentage|5.1||||0.0459|TWO_SIDED|95.0|0.2|10.0||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||10.0|0.2|0.0459
72565452|NCT03575871|144662355|SUPERIORITY||Difference in Percentage|14.2||||0.0005|TWO_SIDED|95.0|7.8|20.5||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||20.5|7.8|0.0005
72565453|NCT03575871|144662355|SUPERIORITY||Difference in Percentage|12.9||||0.0019|TWO_SIDED|95.0|6.3|19.4||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||19.4|6.3|0.0019
72565454|NCT03575871|144662355|SUPERIORITY||Difference in Percentage|31.8|||<|0.0001|TWO_SIDED|95.0|23.6|39.9||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||39.9|23.6|<0.0001
72622589|NCT05339659|144775341|OTHER|The null hypothesis for the significance test is a relative difference=0.|Risk Difference (RD)|0.095||||0.727|TWO_SIDED|95.0|-0.352|0.558|||Barnard's exact test||risk difference=experimental-control|||0.558|-0.352|0.727
72622590|NCT05339659|144775342|OTHER|The null hypothesis for the significance test is 0 difference in average score between arms.|Mean Difference (Final Values)|0.5||||0.325|TWO_SIDED|95.0|-0.6|1.61|||Regression, Linear||mean difference=experimental-control|||1.61|-0.60|0.325
72565455|NCT03575871|144662355|SUPERIORITY||Difference in Percentage|11.9||||0.0246|TWO_SIDED|95.0|2.4|21.4||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||21.4|2.4|0.0246
72470571|NCT04092452|144465178|SUPERIORITY||Risk Difference (RD)|-18.38|STANDARD_ERROR_OF_MEAN|8.23||0.0128|TWO_SIDED|90.0|-31.91|-4.84||One-sided p-value|ANCOVA|||Week 16 Average Pain||-4.84|-31.91|0.0128
72505158|NCT01380093|144541469|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3||||0.3749|TWO_SIDED|95.0|-0.9|0.3|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||0.3|-0.9|0.3749
72505159|NCT01380093|144541469|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1||||0.7939|TWO_SIDED|95.0|-0.5|0.7|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||0.7|-0.5|0.7939
72505160|NCT01380093|144541469|SUPERIORITY_OR_OTHER||LS Mean Difference|0.4||||0.2524|TWO_SIDED|95.0|-0.3|1.0|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||1.0|-0.3|0.2524
72505161|NCT01380093|144541470|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.7||||0.1211|TWO_SIDED|95.0|-3.8|0.5|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||0.5|-3.8|0.1211
72565456|NCT03575871|144662355|SUPERIORITY||Difference in Percentage|26.9|||<|0.0001|TWO_SIDED|95.0|17.0|36.9||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||36.9|17.0|<0.0001
72622591|NCT05339659|144775343|OTHER|The null hypothesis of the significance test is 0 difference in average score between arms.|Mean Difference (Final Values)|0.22||||0.745|TWO_SIDED|95.0|-1.28|1.72|||Regression, Linear||mean difference=experimental-control|||1.72|-1.28|0.745
72395232|NCT01752907|144297144|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|0.3|STANDARD_ERROR_OF_MEAN|0.4||0.3479|TWO_SIDED|95.0|-0.4|1.0|||t-test, 2 sided||Treatment difference = bone pain DVD - general education DVD|There was no statistical hypothesis testing for this study. The clinical hypothesis was that a difference in mean maximum pain of 0.5 (scale 0 to 10) in favor of bone pain education would be a clinically relevant difference.||1.0|-0.4|0.3479
72395233|NCT02670083|144297154|SUPERIORITY||Least Squares Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.354|||TWO_SIDED|95.0|-0.86|0.53||||||||0.53|-0.86|
72505162|NCT01380093|144541470|SUPERIORITY_OR_OTHER||LS Mean Difference|1.4||||0.1997|TWO_SIDED|95.0|-0.7|3.5|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||3.5|-0.7|0.1997
72505163|NCT01380093|144541470|SUPERIORITY_OR_OTHER||LS Mean Difference|3.1||||0.0057|TWO_SIDED|95.0|0.9|5.2|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||5.2|0.9|0.0057
72505164|NCT01380093|144541471|SUPERIORITY_OR_OTHER||LS Mean Difference|-9.8||||0.0057|TWO_SIDED|95.0|-16.7|-3.0|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-3.0|-16.7|0.0057
72505165|NCT01380093|144541471|SUPERIORITY_OR_OTHER||LS Mean Difference|4.5||||0.1918|TWO_SIDED|95.0|-2.3|11.4|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||11.4|-2.3|0.1918
72505166|NCT01380093|144541471|SUPERIORITY_OR_OTHER||LS Mean Difference|14.4|||<|0.0001|TWO_SIDED|95.0|7.5|21.2|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||21.2|7.5|<0.0001
72505167|NCT01380093|144541472|SUPERIORITY_OR_OTHER||LS Mean Difference|-31.5||||0.0013|TWO_SIDED|95.0|-50.2|-12.9|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-12.9|-50.2|0.0013
72505168|NCT01380093|144541472|SUPERIORITY_OR_OTHER||LS Mean Difference|14.9||||0.1136|TWO_SIDED|95.0|-3.7|33.5|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||33.5|-3.7|0.1136
72505169|NCT01380093|144541472|SUPERIORITY_OR_OTHER||LS Mean Difference|46.5|||<|0.0001|TWO_SIDED|95.0|27.8|65.1|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||65.1|27.8|<0.0001
72565457|NCT03575871|144662356|SUPERIORITY||Difference in Percentage|0.0|||||TWO_SIDED|95.0|-3.7|3.7||P-value was not estimable since there were no events.||||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||3.7|-3.7|
72565458|NCT03575871|144662356|SUPERIORITY||Difference in Percentage|1.9||||0.2262|TWO_SIDED|95.0|-2.2|6.1||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||6.1|-2.2|0.2262
72505170|NCT01380093|144541473|SUPERIORITY_OR_OTHER||LS Mean Difference|-53.6||||0.0006|TWO_SIDED|95.0|-83.2|-24.0|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-24.0|-83.2|0.0006
72505171|NCT01380093|144541473|SUPERIORITY_OR_OTHER||LS Mean Difference|23.2||||0.1207|TWO_SIDED|95.0|-6.3|52.7|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||52.7|-6.3|0.1207
72505172|NCT01380093|144541473|SUPERIORITY_OR_OTHER||LS Mean Difference|76.8|||<|0.0001|TWO_SIDED|95.0|47.3|106.4|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||106.4|47.3|<0.0001
72565459|NCT03575871|144662356|SUPERIORITY||Difference in Percentage|1.9||||0.2223|TWO_SIDED|95.0|-2.2|6.1||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||6.1|-2.2|0.2223
72565460|NCT03575871|144662356|SUPERIORITY||Difference in Percentage|4.5||||0.0597|TWO_SIDED|95.0|-0.2|9.2||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||9.2|-0.2|0.0597
72565461|NCT03575871|144662356|SUPERIORITY||Difference in Percentage|1.3||||0.3207|TWO_SIDED|95.0|-2.7|5.2||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||5.2|-2.7|0.3207
72565462|NCT03575871|144662356|SUPERIORITY||Difference in Percentage|4.5||||0.0586|TWO_SIDED|95.0|-0.2|9.2||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||9.2|-0.2|0.0586
72565463|NCT03575871|144662356|SUPERIORITY||Difference in Percentage|5.2||||0.0419|TWO_SIDED|95.0|0.3|10.1||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||10.1|0.3|0.0419
72565464|NCT03575871|144662356|SUPERIORITY||Difference in Percentage|6.3||||0.0244|TWO_SIDED|95.0|1.2|11.4||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||11.4|1.2|0.0244
72565465|NCT03575871|144662357|SUPERIORITY||Difference in Percentage|25.0|||<|0.0001|TWO_SIDED|95.0|14.8|35.2||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||35.2|14.8|<0.0001
72565466|NCT03575871|144662357|SUPERIORITY||Difference in Percentage|44.2|||<|0.0001|TWO_SIDED|95.0|33.9|54.6||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||54.6|33.9|<0.0001
72565467|NCT03575871|144662357|SUPERIORITY||Difference in Percentage|30.2|||<|0.0001|TWO_SIDED|95.0|17.5|42.8||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||42.8|17.5|<0.0001
72565468|NCT03575871|144662357|SUPERIORITY||Difference in Percentage|49.8|||<|0.0001|TWO_SIDED|95.0|37.8|61.7||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||61.7|37.8|<0.0001
72565469|NCT03575871|144662357|SUPERIORITY||Difference in Percentage|31.5|||<|0.0001|TWO_SIDED|95.0|18.8|44.3||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||44.3|18.8|<0.0001
72565470|NCT03575871|144662357|SUPERIORITY||Difference in Percentage|47.6|||<|0.0001|TWO_SIDED|95.0|35.7|59.6||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||59.6|35.7|<0.0001
72565471|NCT03575871|144662357|SUPERIORITY||Difference in Percentage|48.7|||<|0.0001|TWO_SIDED|95.0|37.2|60.1||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||60.1|37.2|<0.0001
72565472|NCT03575871|144662357|SUPERIORITY||Difference in Percentage|60.1|||<|0.0001|TWO_SIDED|95.0|49.1|71.0||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||71.0|49.1|<0.0001
72565473|NCT03575871|144662358|SUPERIORITY||Difference in Percentage|2.5||||0.1623|TWO_SIDED|95.0|-1.7|6.8||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||6.8|-1.7|0.1623
72565474|NCT03575871|144662358|SUPERIORITY||Difference in Percentage|9.1||||0.007|TWO_SIDED|95.0|3.4|14.7||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||14.7|3.4|0.0070
72565475|NCT03575871|144662358|SUPERIORITY||Difference in Percentage|9.7||||0.0049|TWO_SIDED|95.0|4.0|15.4||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||15.4|4.0|0.0049
72565476|NCT03575871|144662358|SUPERIORITY||Difference in Percentage|22.9|||<|0.0001|TWO_SIDED|95.0|15.5|30.2||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||30.2|15.5|<0.0001
72565477|NCT03575871|144662358|SUPERIORITY||Difference in Percentage|14.6||||0.0013|TWO_SIDED|95.0|7.2|22.0||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||22.0|7.2|0.0013
72565478|NCT03575871|144662358|SUPERIORITY||Difference in Percentage|31.6|||<|0.0001|TWO_SIDED|95.0|23.1|40.1||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||40.1|23.1|<0.0001
72565479|NCT03575871|144662358|SUPERIORITY||Difference in Percentage|20.1||||0.0001|TWO_SIDED|95.0|11.9|28.3||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||28.3|11.9|0.0001
72565480|NCT03575871|144662358|SUPERIORITY||Difference in Percentage|33.5|||<|0.0001|TWO_SIDED|95.0|24.6|42.5|||Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||42.5|24.6|<0.0001
72565481|NCT03575871|144662359|SUPERIORITY||Difference in Percentage|0.0|||||TWO_SIDED|95.0|-3.7|3.7||P-value could not be calculated since percentage of participants with events was 0.||||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||3.7|-3.7|
72565482|NCT03575871|144662359|SUPERIORITY||Difference in Percentage|1.3||||0.3261|TWO_SIDED|95.0|-2.8|5.3||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||5.3|-2.8|0.3261
72565483|NCT03575871|144662359|SUPERIORITY||Difference in Percentage|1.3||||0.3207|TWO_SIDED|95.0|-2.7|5.3||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||5.3|-2.7|0.3207
72565484|NCT03575871|144662359|SUPERIORITY||Difference in Percentage|3.9||||0.081|TWO_SIDED|95.0|-0.8|8.5||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||8.5|-0.8|0.0810
72622592|NCT05339659|144775344|OTHER|The null hypothesis of the significance test is a risk difference=0.|Risk Difference (RD)|0.58||||0.009|TWO_SIDED|95.0|0.16|0.85|||Barnard's exact test||risk difference=experimental-control|||0.85|0.16|0.009
72565485|NCT03575871|144662359|SUPERIORITY||Difference in Percentage|1.3||||0.3207|TWO_SIDED|95.0|-2.7|5.2||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||5.2|-2.7|0.3207
72565486|NCT03575871|144662359|SUPERIORITY||Difference in Percentage|3.8||||0.081|TWO_SIDED|95.0|-0.7|8.4||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||8.4|-0.7|0.0810
72565487|NCT03575871|144662359|SUPERIORITY||Difference in Percentage|5.2||||0.0419|TWO_SIDED|95.0|0.3|10.1||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||10.1|0.3|0.0419
72565488|NCT03575871|144662359|SUPERIORITY||Difference in Percentage|7.0||||0.018|TWO_SIDED|95.0|1.8|12.2||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||12.2|1.8|0.0180
72565489|NCT03575871|144662360|SUPERIORITY||Difference in LS mean|-30.2|||<|0.0001|TWO_SIDED|95.0|-38.1|-22.3|||Mixed Models Analysis|||Change at Week 2: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-22.3|-38.1|<0.0001
72565490|NCT03575871|144662360|SUPERIORITY||Difference in LS mean|-42.3|||<|0.0001|TWO_SIDED|95.0|-50.3|-34.4|||Mixed Models Analysis|||Change at Week 2: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-34.4|-50.3|<0.0001
72565491|NCT03575871|144662360|SUPERIORITY||Difference in LS mean|-29.9|||<|0.0001|TWO_SIDED|95.0|-38.1|-21.7|||Mixed Models Analysis|||Change at Week 4: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-21.7|-38.1|<0.0001
72622593|NCT05339659|144775347|OTHER|The null hypothesis for the significance test is a mean difference of 0 cigarettes/day between arms.|Mean Difference (Final Values)|1.39||||0.469|TWO_SIDED|95.0|-2.66|5.44|||Regression, Linear|Adjusted for baseline cigarettes/day.|mean difference=experimental-control|||5.44|-2.66|0.469
72565492|NCT03575871|144662360|SUPERIORITY||Difference in LS mean|-44.6|||<|0.0001|TWO_SIDED|95.0|-52.8|-36.3|||Mixed Models Analysis|||Change at Week 4: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-36.3|-52.8|<0.0001
72565493|NCT03575871|144662360|SUPERIORITY||Difference in LS mean|-26.4|||<|0.0001|TWO_SIDED|95.0|-36.2|-16.7|||Mixed Models Analysis|||Change at Week 8: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-16.7|-36.2|<0.0001
72565494|NCT03575871|144662360|SUPERIORITY||Difference in LS mean|-40.2|||<|0.0001|TWO_SIDED|95.0|-50.0|-30.4|||Mixed Models Analysis|||Change at Week 8: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-30.4|-50.0|<0.0001
72565495|NCT03575871|144662360|SUPERIORITY||Difference in LS mean|-31.4|||<|0.0001|TWO_SIDED|95.0|-43.1|-19.7|||Mixed Models Analysis|||Change at Week 12: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-19.7|-43.1|<0.0001
72622594|NCT05339659|144775348|OTHER|The null hypothesis for the significance test is a mean difference of 0 cigarettes/day between arms.|Mean Difference (Final Values)|-0.66||||0.614|TWO_SIDED|95.0|-3.48|2.16|||Regression, Linear|Adjusted for baseline cigarettes/day.|mean difference=experimental-control|||2.16|-3.48|0.614
72395234|NCT02670083|144297155|SUPERIORITY||Least Squares Mean Difference|-0.26|STANDARD_ERROR_OF_MEAN|1.083|||TWO_SIDED|95.0|-2.39|1.87||||||||1.87|-2.39|
72470572|NCT04092452|144465178|SUPERIORITY||Risk Difference (RD)|-4.09|STANDARD_ERROR_OF_MEAN|8.639||0.3181|TWO_SIDED|90.0|-18.3|10.12||One-sided p-value|ANCOVA|||Week 16 Average Pain||10.12|-18.30|0.3181
72470573|NCT04092452|144465179|SUPERIORITY||Risk Difference (RD)|-0.31|STANDARD_ERROR_OF_MEAN|0.301||0.1536|TWO_SIDED|90.0|-0.8|0.19||One-sided p-value|ANCOVA|||Week 1 Pain at its Worst||0.19|-0.80|0.1536
72470574|NCT04092452|144465179|SUPERIORITY||Risk Difference (RD)|-0.45|STANDARD_ERROR_OF_MEAN|0.289||0.0581|TWO_SIDED|90.0|-0.93|0.02||One-sided p-value|ANCOVA|||Week 1 Pain at its Worst||0.02|-0.93|0.0581
72470575|NCT04092452|144465179|SUPERIORITY||Risk Difference (RD)|-0.48|STANDARD_ERROR_OF_MEAN|0.3||0.0532|TWO_SIDED|90.0|-0.98|0.01||One-sided p-value|ANCOVA|||Week 1 Pain at its Worst||0.01|-0.98|0.0532
72470576|NCT04092452|144465179|SUPERIORITY||Risk Difference (RD)|-0.32|STANDARD_ERROR_OF_MEAN|0.383||0.2007|TWO_SIDED|90.0|-0.95|0.31||One-sided p-value|ANCOVA|||Week 2 Pain at its Worst||0.31|-0.95|0.2007
72470577|NCT04092452|144465179|SUPERIORITY||Risk Difference (RD)|-0.55|STANDARD_ERROR_OF_MEAN|0.37||0.0694|TWO_SIDED|90.0|-1.16|0.06||One-sided p-value|ANCOVA|||Week 2 Pain at its Worst||0.06|-1.16|0.0694
72470578|NCT04092452|144465179|SUPERIORITY||Risk Difference (RD)|-0.39|STANDARD_ERROR_OF_MEAN|0.382||0.1509|TWO_SIDED|90.0|-1.02|0.23||One-sided p-value|ANCOVA|||Week 2 Pain at its Worst||0.23|-1.02|0.1509
72470579|NCT04092452|144465179|SUPERIORITY||Risk Difference (RD)|0.07|STANDARD_ERROR_OF_MEAN|0.431||0.5663|TWO_SIDED|90.0|-0.64|0.78||One-sided p-value|ANCOVA|||Week 4 Pain at its Worst||0.78|-0.64|0.5663
72470580|NCT04092452|144465179|SUPERIORITY||Risk Difference (RD)|-0.45|STANDARD_ERROR_OF_MEAN|0.416||0.1396|TWO_SIDED|90.0|-1.13|0.23||One-sided p-value|ANCOVA|||Week 4 Pain at its Worst||0.23|-1.13|0.1396
72395235|NCT02670083|144297156|SUPERIORITY||Least Squares Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|1.006|||TWO_SIDED|95.0|-2.08|1.88||||||||1.88|-2.08|
72470581|NCT04092452|144465179|SUPERIORITY||Risk Difference (RD)|0.02|STANDARD_ERROR_OF_MEAN|0.432||0.5227|TWO_SIDED|90.0|-0.69|0.74||One-sided p-value|ANCOVA|||Week 4 Pain at its Worst||0.74|-0.69|0.5227
72470582|NCT04092452|144465179|SUPERIORITY||Risk Difference (RD)|0.5|STANDARD_ERROR_OF_MEAN|0.45||0.8656|TWO_SIDED|90.0|-0.24|1.24||One-sided p-value|ANCOVA|||Week 6 Pain at its Worst||1.24|-0.24|0.8656
72470583|NCT04092452|144465179|SUPERIORITY||Risk Difference (RD)|-0.42|STANDARD_ERROR_OF_MEAN|0.434||0.1671|TWO_SIDED|90.0|-1.13|0.29||One-sided p-value|ANCOVA|||Week 6 Pain at its Worst||0.29|-1.13|0.1671
72470584|NCT04092452|144465179|SUPERIORITY||Risk Difference (RD)|0.12|STANDARD_ERROR_OF_MEAN|0.45||0.6063|TWO_SIDED|90.0|-0.62|0.86||One-sided p-value|ANCOVA|||Week 6 Pain at its Worst||0.86|-0.62|0.6063
72470585|NCT04092452|144465179|SUPERIORITY||Risk Difference (RD)|0.16|STANDARD_ERROR_OF_MEAN|0.458||0.6402|TWO_SIDED|90.0|-0.59|0.92||One-sided p-value|ANCOVA|||Week 8 Pain at its Worst||0.92|-0.59|0.6402
72470586|NCT04092452|144465179|SUPERIORITY||Risk Difference (RD)|-0.38|STANDARD_ERROR_OF_MEAN|0.441||0.1916|TWO_SIDED|90.0|-1.11|0.34||One-sided p-value|ANCOVA|||Week 8 Pain at its Worst||0.34|-1.11|0.1916
72470587|NCT04092452|144465179|SUPERIORITY||Risk Difference (RD)|0.13|STANDARD_ERROR_OF_MEAN|0.456||0.6119|TWO_SIDED|90.0|-0.62|0.88||One-sided p-value|ANCOVA|||Week 8 Pain at its Worst||0.88|-0.62|0.6119
72470588|NCT04092452|144465179|SUPERIORITY||Risk Difference (RD)|0.06|STANDARD_ERROR_OF_MEAN|0.45||0.5568|TWO_SIDED|90.0|-0.68|0.8||One-sided p-value|ANCOVA|||Week 12 Pain at its Worst||0.80|-0.68|0.5568
72470589|NCT04092452|144465179|SUPERIORITY||Risk Difference (RD)|-0.56|STANDARD_ERROR_OF_MEAN|0.433||0.0976|TWO_SIDED|90.0|-1.27|0.15||One-sided p-value|ANCOVA|||Week 12 Pain at its Worst||0.15|-1.27|0.0976
72470590|NCT04092452|144465179|SUPERIORITY||Risk Difference (RD)|0.0|STANDARD_ERROR_OF_MEAN|0.451||0.5001|TWO_SIDED|90.0|-0.74|0.74||One-sided p-value|ANCOVA|||Week 12 Pain at its Worst||0.74|-0.74|0.5001
72470591|NCT04092452|144465179|SUPERIORITY||Risk Difference (RD)|0.09|STANDARD_ERROR_OF_MEAN|0.451||0.581|TWO_SIDED|90.0|-0.65|0.83||One-sided p-value|ANCOVA|||Week 16 Pain at its Worst||0.83|-0.65|0.5810
72470592|NCT04092452|144465179|SUPERIORITY||Risk Difference (RD)|-1.07|STANDARD_ERROR_OF_MEAN|0.442||0.0079|TWO_SIDED|90.0|-1.8|-0.34||One-sided p-value|ANCOVA|||Week 16 Pain at its Worst||-0.34|-1.80|0.0079
72470593|NCT04092452|144465179|SUPERIORITY||Risk Difference (RD)|-0.57|STANDARD_ERROR_OF_MEAN|0.455||0.1068|TWO_SIDED|90.0|-1.31|0.18||One-sided p-value|ANCOVA|||Week 16 Pain at its Worst||0.18|-1.31|0.1068
72470594|NCT04092452|144465180|SUPERIORITY||Risk Difference (RD)|-0.25|STANDARD_ERROR_OF_MEAN|0.284||0.1898|TWO_SIDED|90.0|-0.72|0.22||One-sided p-value|ANCOVA|||Week 1 Average Pain||0.22|-0.72|0.1898
72470595|NCT04092452|144465180|SUPERIORITY||Risk Difference (RD)|-0.43|STANDARD_ERROR_OF_MEAN|0.273||0.0562|TWO_SIDED|90.0|-0.88|0.02||One-sided p-value|ANCOVA|||Week 1 Average Pain||0.02|-0.88|0.0562
72470596|NCT04092452|144465180|SUPERIORITY||Risk Difference (RD)|-0.31|STANDARD_ERROR_OF_MEAN|0.284||0.1382|TWO_SIDED|90.0|-0.78|0.16||One-sided p-value|ANCOVA|||Week 1 Average Pain||0.16|-0.78|0.1382
72470597|NCT04092452|144465180|SUPERIORITY||Risk Difference (RD)|-0.28|STANDARD_ERROR_OF_MEAN|0.343||0.2039|TWO_SIDED|90.0|-0.85|0.28||One-sided p-value|ANCOVA|||Week 2 Average Pain||0.28|-0.85|0.2039
72470598|NCT04092452|144465180|SUPERIORITY||Risk Difference (RD)|-0.45|STANDARD_ERROR_OF_MEAN|0.332||0.0855|TWO_SIDED|90.0|-1.0|0.09||One-sided p-value|ANCOVA|||Week 2 Average Pain||0.09|-1.00|0.0855
72470599|NCT04092452|144465180|SUPERIORITY||Risk Difference (RD)|-0.17|STANDARD_ERROR_OF_MEAN|0.344||0.3089|TWO_SIDED|90.0|-0.74|0.39||One-sided p-value|ANCOVA|||Week 2 Average Pain||0.39|-0.74|0.3089
72470600|NCT04092452|144465180|SUPERIORITY||Risk Difference (RD)|0.12|STANDARD_ERROR_OF_MEAN|0.407||0.6124|TWO_SIDED|90.0|-0.55|0.79||One-sided p-value|ANCOVA|||Week 4 Average Pain||0.79|-0.55|0.6124
72470601|NCT04092452|144465180|SUPERIORITY||Risk Difference (RD)|-0.5|STANDARD_ERROR_OF_MEAN|0.395||0.1003|TWO_SIDED|90.0|-1.15|0.14||One-sided p-value|ANCOVA|||Week 4 Average Pain||0.14|-1.15|0.1003
72470602|NCT04092452|144465180|SUPERIORITY||Risk Difference (RD)|0.2|STANDARD_ERROR_OF_MEAN|0.408||0.6875|TWO_SIDED|90.0|-0.47|0.87||One-sided p-value|ANCOVA|||Week 4 Average Pain||0.87|-0.47|0.6875
72470603|NCT04092452|144465180|SUPERIORITY||Risk Difference (RD)|0.51|STANDARD_ERROR_OF_MEAN|0.427||0.8833|TWO_SIDED|90.0|-0.19|1.21||One-sided p-value|ANCOVA|||Week 6 Average Pain||1.21|-0.19|0.8833
72470604|NCT04092452|144465180|SUPERIORITY||Risk Difference (RD)|-0.43|STANDARD_ERROR_OF_MEAN|0.413||0.1502|TWO_SIDED|90.0|-1.11|0.25||One-sided p-value|ANCOVA|||Week 6 Average Pain||0.25|-1.11|0.1502
72470605|NCT04092452|144465180|SUPERIORITY||Risk Difference (RD)|0.2|STANDARD_ERROR_OF_MEAN|0.428||0.6788|TWO_SIDED|90.0|-0.5|0.9||One-sided p-value|ANCOVA|||Week 6 Average Pain||0.90|-0.50|0.6788
72470606|NCT04092452|144465180|SUPERIORITY||Risk Difference (RD)|0.21|STANDARD_ERROR_OF_MEAN|0.441||0.6835|TWO_SIDED|90.0|-0.51|0.94||One-sided p-value|ANCOVA|||Week 8 Average Pain||0.94|-0.51|0.6835
72470607|NCT04092452|144465180|SUPERIORITY||Risk Difference (RD)|-0.32|STANDARD_ERROR_OF_MEAN|0.425||0.2237|TWO_SIDED|90.0|-1.02|0.38||One-sided p-value|ANCOVA|||Week 8 Average Pain||0.38|-1.02|0.2237
72470608|NCT04092452|144465180|SUPERIORITY||Risk Difference (RD)|0.26|STANDARD_ERROR_OF_MEAN|0.439||0.7234|TWO_SIDED|90.0|-0.46|0.98||One-sided p-value|ANCOVA|||Week 8 Average Pain||0.98|-0.46|0.7234
72470609|NCT04092452|144465180|SUPERIORITY||Risk Difference (RD)|-0.02|STANDARD_ERROR_OF_MEAN|0.424||0.4773|TWO_SIDED|90.0|-0.72|0.67||One-sided p-value|ANCOVA|||Week 12 Average Pain||0.67|-0.72|0.4773
72505173|NCT01380093|144541474|SUPERIORITY_OR_OTHER||LS Mean Difference|-75.8||||0.0008|TWO_SIDED|95.0|-118.6|-33.0|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-33.0|-118.6|0.0008
72505174|NCT01380093|144541474|SUPERIORITY_OR_OTHER||LS Mean Difference|31.8||||0.141|TWO_SIDED|95.0|-10.8|74.5|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||74.5|-10.8|0.1410
72470610|NCT04092452|144465180|SUPERIORITY||Risk Difference (RD)|-0.57|STANDARD_ERROR_OF_MEAN|0.41||0.0818|TWO_SIDED|90.0|-1.25|0.1||One-sided p-value|ANCOVA|||Week 12 Average Pain||0.10|-1.25|0.0818
72470611|NCT04092452|144465180|SUPERIORITY||Risk Difference (RD)|0.15|STANDARD_ERROR_OF_MEAN|0.424||0.6397|TWO_SIDED|90.0|-0.55|0.85||One-sided p-value|ANCOVA|||Week 12 Average Pain||0.85|-0.55|0.6397
72470612|NCT04092452|144465180|SUPERIORITY||Risk Difference (RD)|0.03|STANDARD_ERROR_OF_MEAN|0.428||0.5321|TWO_SIDED|90.0|-0.67|0.74||One-sided p-value|ANCOVA|||Week 16 Average Pain||0.74|-0.67|0.5321
72470613|NCT04092452|144465180|SUPERIORITY||Risk Difference (RD)|-0.89|STANDARD_ERROR_OF_MEAN|0.42||0.0167|TWO_SIDED|90.0|-1.59|-0.2||One-sided p-value|ANCOVA|||Week 16 Average Pain||-0.20|-1.59|0.0167
72470614|NCT04092452|144465180|SUPERIORITY||Risk Difference (RD)|-0.37|STANDARD_ERROR_OF_MEAN|0.434||0.1963|TWO_SIDED|90.0|-1.09|0.34||One-sided p-value|ANCOVA|||Week 16 Average Pain||0.34|-1.09|0.1963
72470615|NCT04092452|144465181|SUPERIORITY||Risk Difference (RD)|-2.2|STANDARD_ERROR_OF_MEAN|4.98|||TWO_SIDED|90.0|-10.3|6.0||||||Week 1||6.0|-10.3|
72470616|NCT04092452|144465181|SUPERIORITY||Risk Difference (RD)|2.0|STANDARD_ERROR_OF_MEAN|5.64|||TWO_SIDED|90.0|-7.3|11.3||||||Week 1||11.3|-7.3|
72470617|NCT04092452|144465181|SUPERIORITY||Risk Difference (RD)|6.8|STANDARD_ERROR_OF_MEAN|6.47|||TWO_SIDED|90.0|-3.9|17.4||||||Week 1||17.4|-3.9|
72470618|NCT04092452|144465181|SUPERIORITY||Risk Difference (RD)|10.7|STANDARD_ERROR_OF_MEAN|7.74|||TWO_SIDED|90.0|-2.0|23.4||||||Week 2||23.4|-2.0|
72470619|NCT04092452|144465181|SUPERIORITY||Risk Difference (RD)|7.6|STANDARD_ERROR_OF_MEAN|7.34|||TWO_SIDED|90.0|-4.5|19.7||||||Week 2||19.7|-4.5|
72470620|NCT04092452|144465181|SUPERIORITY||Risk Difference (RD)|7.5|STANDARD_ERROR_OF_MEAN|7.36|||TWO_SIDED|90.0|-4.6|19.6||||||Week 2||19.6|-4.6|
72470621|NCT04092452|144465181|SUPERIORITY||Risk Difference (RD)|7.4|STANDARD_ERROR_OF_MEAN|7.95|||TWO_SIDED|90.0|-5.7|20.5||||||Week 4||20.5|-5.7|
72470622|NCT04092452|144465181|SUPERIORITY||Risk Difference (RD)|15.1|STANDARD_ERROR_OF_MEAN|8.33|||TWO_SIDED|90.0|1.4|28.7||||||Week 4||28.7|1.4|
72470623|NCT04092452|144465181|SUPERIORITY||Risk Difference (RD)|4.8|STANDARD_ERROR_OF_MEAN|7.74|||TWO_SIDED|90.0|-8.0|17.5||||||Week 4||17.5|-8.0|
72470624|NCT04092452|144465181|SUPERIORITY||Risk Difference (RD)|14.3|STANDARD_ERROR_OF_MEAN|8.3|||TWO_SIDED|90.0|0.7|28.0||||||Week 6||28.0|0.7|
72470625|NCT04092452|144465181|SUPERIORITY||Risk Difference (RD)|10.9|STANDARD_ERROR_OF_MEAN|7.96|||TWO_SIDED|90.0|-2.2|24.0||||||Week 6||24.0|-2.2|
72470626|NCT04092452|144465181|SUPERIORITY||Risk Difference (RD)|10.6|STANDARD_ERROR_OF_MEAN|8.06|||TWO_SIDED|90.0|-2.6|23.9||||||Week 6||23.9|-2.6|
72470627|NCT04092452|144465181|SUPERIORITY||Risk Difference (RD)|10.1|STANDARD_ERROR_OF_MEAN|8.38||0.1162|TWO_SIDED|90.0|-3.6|23.9||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 8||23.9|-3.6|0.1162
72470628|NCT04092452|144465181|SUPERIORITY||Risk Difference (RD)|13.1|STANDARD_ERROR_OF_MEAN|8.43||0.0642|TWO_SIDED|90.0|-0.8|27.0||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 8||27.0|-0.8|0.0642
72505175|NCT01380093|144541474|SUPERIORITY_OR_OTHER||LS Mean Difference|107.7|||<|0.0001|TWO_SIDED|95.0|64.9|150.5|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||150.5|64.9|<0.0001
72565496|NCT03575871|144662360|SUPERIORITY||Difference in LS mean|-44.7|||<|0.0001|TWO_SIDED|95.0|-56.4|-33.0|||Mixed Models Analysis|||Change at Week 12: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-33.0|-56.4|<0.0001
72395236|NCT02670083|144297157|SUPERIORITY||Least Squares Mean Difference|0.05|STANDARD_ERROR_OF_MEAN|0.076|||TWO_SIDED|95.0|-0.1|0.2||||||||0.20|-0.10|
72395237|NCT02670083|144297158|SUPERIORITY||Least Squares Mean Difference|0.33|STANDARD_ERROR_OF_MEAN|0.486|||TWO_SIDED|95.0|-0.62|1.29||||||||1.29|-0.62|
72395238|NCT02670083|144297159|SUPERIORITY||Least Squares Mean Difference|1.88|STANDARD_ERROR_OF_MEAN|1.679|||TWO_SIDED|95.0|-1.43|5.18||||||||5.18|-1.43|
72395239|NCT02670083|144297160|SUPERIORITY||Least Squares Mean Difference|1.22|STANDARD_ERROR_OF_MEAN|1.306|||TWO_SIDED|95.0|-1.35|3.79||||||||3.79|-1.35|
72395240|NCT02670083|144297162|SUPERIORITY||Least Squares Mean Difference|-0.53|STANDARD_ERROR_OF_MEAN|0.723|||TWO_SIDED|95.0|-1.95|0.9||||||||0.90|-1.95|
72395241|NCT02670083|144297163|SUPERIORITY||Least Squares Mean Difference|0.4|STANDARD_ERROR_OF_MEAN|0.609|||TWO_SIDED|95.0|-0.81|1.6||||||||1.60|-0.81|
72395242|NCT02670083|144297164|SUPERIORITY||Least Squares Mean Difference|-1.39|STANDARD_ERROR_OF_MEAN|6.214|||TWO_SIDED|95.0|-13.64|10.86||||||||10.86|-13.64|
72395243|NCT02670083|144297165|SUPERIORITY||Least Squares Mean Difference|1.82|STANDARD_ERROR_OF_MEAN|2.26|||TWO_SIDED|95.0|-2.64|6.27||||||||6.27|-2.64|
72395244|NCT02670083|144297166|SUPERIORITY||Least Squares Mean Difference|0.94|STANDARD_ERROR_OF_MEAN|2.222|||TWO_SIDED|95.0|-3.45|5.32||||||||5.32|-3.45|
72395245|NCT02670083|144297172|SUPERIORITY||Least Squares Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.116|||TWO_SIDED|95.0|-0.24|0.22||||||||0.22|-0.24|
72395246|NCT02670083|144297173|SUPERIORITY||Least Squares Mean Difference|-1.28|STANDARD_ERROR_OF_MEAN|1.245|||TWO_SIDED|95.0|-3.72|1.17||||||||1.17|-3.72|
72395247|NCT02670083|144297174|SUPERIORITY||Least Squares Mean Difference|0.39|STANDARD_ERROR_OF_MEAN|0.253|||TWO_SIDED|95.0|-0.1|0.89||||||||0.89|-0.10|
72395248|NCT02057406|144297220|SUPERIORITY|The EPA/DHA arm versus placebo at Week 12.||||||0.74|||||||ANCOVA|||The model used post-treatment HAMD values as the dependent variable and included age, race, sex, treatment site, and the baseline HAMD value as covariates. This analysis was conducted under intention-to-treat (ITT) in which the missing HAMD endpoint values were imputed using 50 imputations.||||0.74
72395249|NCT02057406|144297220|SUPERIORITY|High EPA group versus placebo group at Week 12.||||||0.45|||||||ANCOVA|||The model used post-treatment HAMD values as the dependent variable and included age, race, sex, treatment site, and the baseline HAMD value as covariates. This analysis was conducted under intention-to-treat (ITT) in which the missing HAMD endpoint values were imputed using 50 imputations.||||0.45
72395250|NCT02057406|144297221|SUPERIORITY|Active supplements (2:1 EPA/DHA and High EPA combined) versus placebo at Week 12.|||||<|0.0001|||||||ANCOVA|||The model used post-treatment EPA values as the dependent variable and included age, race, sex, treatment site, and the baseline EPA value as covariates. This analyses was conducted under intention-to-treat (ITT) in which the missing EPA endpoint values were imputed using 50 imputations.||||<0.0001
72395251|NCT02057406|144297221|SUPERIORITY|2:1 EPA/DHA versus High EPA at Week 12.||||||0.12|||||||ANCOVA|||The model used post-treatment EPA values as the dependent variable and included age, race, sex, treatment site, and the baseline EPA value as covariates. This analyses was conducted under intention-to-treat (ITT) in which the missing EPA endpoint values were imputed using 50 imputations.||||0.12
72395252|NCT03654651|144297222|SUPERIORITY||Mean Difference (Final Values)|-0.6|||||TWO_SIDED|95.0|-2.7|1.6|||Mixed Models Analysis|||||1.6|-2.7|
72395253|NCT03654651|144297222|OTHER|change from baseline|Mean Difference (Final Values)|-0.9|||||TWO_SIDED|95.0|-2.7|0.9|||Mixed Models Analysis|||||0.9|-2.7|
72395254|NCT03654651|144297222|OTHER|Change from baseline|Mean Difference (Final Values)|-0.4|||||TWO_SIDED|95.0|-2.2|1.4|||Mixed Models Analysis|||||1.4|-2.2|
72395255|NCT03654651|144297223|SUPERIORITY||Mean Difference (Final Values)|0.7|||||TWO_SIDED|95.0|-4.8|3.4|||Mixed Models Analysis|||||3.4|-4.8|
72395256|NCT03654651|144297223|OTHER|change from baseline|Mean Difference (Final Values)|-4.0|||||TWO_SIDED|95.0|-5.1|5.4|||Mixed Models Analysis|||||5.4|-5.1|
72395257|NCT03654651|144297223|OTHER|change from baseline|Mean Difference (Final Values)|-3.8|||||TWO_SIDED|95.0|-5.1|5.4|||Mixed Models Analysis|||||5.4|-5.1|
72395258|NCT03654651|144297224|SUPERIORITY||Mean Difference (Final Values)|0.45|||||TWO_SIDED|95.0|-1.2|2.1|||Mixed Models Analysis|||||2.1|-1.2|
72395259|NCT03654651|144297224|OTHER|change from baseline|Mean Difference (Final Values)|-0.2|||||TWO_SIDED|95.0|-1.5|1.0|||Mixed Models Analysis|||||1.0|-1.5|
72395260|NCT03654651|144297224|OTHER|change from baseline|Mean Difference (Final Values)|-0.8|||||TWO_SIDED|95.0|-2.1|0.5|||Mixed Models Analysis|||||0.5|-2.1|
72565497|NCT03575871|144662361|SUPERIORITY||Difference in LS mean|-26.5|||<|0.0001|TWO_SIDED|95.0|-35.5|-17.5|||Mixed Models Analysis|||Change at Week 2: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-17.5|-35.5|<0.0001
72395261|NCT03654651|144297225|SUPERIORITY||Mean Difference (Final Values)|0.7|||||TWO_SIDED|95.0|-3.1|4.6|||Mixed Models Analysis|||peripheral systolic BP||4.6|-3.1|
72395262|NCT03654651|144297225|SUPERIORITY||Mean Difference (Final Values)|0.4|||||TWO_SIDED|95.0|-2.1|2.9|||Mixed Models Analysis|||peripheral diastolic BP||2.9|-2.1|
72395263|NCT03654651|144297225|OTHER|change from baseline|Mean Difference (Final Values)|0.4|||||TWO_SIDED|95.0|-2.5|3.3|||Mixed Models Analysis|||peripheral systolic BP change from baseline||3.3|-2.5|
72395264|NCT03654651|144297225|OTHER|change from baseline|Mean Difference (Final Values)|-0.3|||||TWO_SIDED|95.0|-3.1|2.6|||Mixed Models Analysis|||peripheral systolic BP change from baseline||2.6|-3.1|
72395265|NCT03654651|144297225|OTHER|change from baseline|Mean Difference (Final Values)|0.5|||||TWO_SIDED|95.0|-1.5|2.5|||Mixed Models Analysis|||peripheral diastolic BP change from baseline||2.5|-1.5|
72395266|NCT03654651|144297225|OTHER|change from baseline|Mean Difference (Final Values)|0.0|||||TWO_SIDED|95.0|-2.0|2.0|||Mixed Models Analysis|||peripheral diastolic BP change from baseline||2|-2|
72395267|NCT03654651|144297226|SUPERIORITY||Mean Difference (Final Values)|1.0|||||TWO_SIDED|95.0|-2.4|4.4|||Mixed Models Analysis|||central systolic BP||4.4|-2.4|
72395268|NCT03654651|144297226|SUPERIORITY||Mean Difference (Final Values)|0.8|||||TWO_SIDED|95.0|-1.7|3.3|||Mixed Models Analysis|||central diastolic BP||3.3|-1.7|
72505176|NCT01380093|144541475|SUPERIORITY_OR_OTHER||LS Mean Difference|-10.0|||<|0.0001|TWO_SIDED|95.0|-14.4|-5.6|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-5.6|-14.4|<0.0001
72505177|NCT01380093|144541475|SUPERIORITY_OR_OTHER||LS Mean Difference|4.3||||0.0529|TWO_SIDED|95.0|-0.1|8.7|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||8.7|-0.1|0.0529
72505178|NCT01380093|144541475|SUPERIORITY_OR_OTHER||LS Mean Difference|14.3|||<|0.0001|TWO_SIDED|95.0|9.9|18.7|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||18.7|9.9|<0.0001
72505179|NCT01380093|144541476|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.8||||0.0806|TWO_SIDED|95.0|-3.8|0.2|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||0.2|-3.8|0.0806
72395269|NCT03654651|144297226|OTHER|change from baseline|Mean Difference (Final Values)|0.6|||||TWO_SIDED|95.0|-1.9|3.1|||Mixed Models Analysis|||central systolic BP change from baseline||3.1|-1.9|
72505180|NCT01380093|144541476|SUPERIORITY_OR_OTHER||LS Mean Difference|1.1||||0.2769|TWO_SIDED|95.0|-0.9|3.1|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||3.1|-0.9|0.2769
72505181|NCT01380093|144541476|SUPERIORITY_OR_OTHER||LS Mean Difference|2.9||||0.0056|TWO_SIDED|95.0|0.9|5.0|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||5.0|0.9|0.0056
72505182|NCT01380093|144541477|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.8||||0.11|TWO_SIDED|95.0|-1.7|0.2|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||0.2|-1.7|0.1100
72505183|NCT01380093|144541477|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0||||0.9421|TWO_SIDED|95.0|-1.0|0.9|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||0.9|-1.0|0.9421
72505184|NCT01380093|144541477|SUPERIORITY_OR_OTHER||LS Mean Difference|0.7||||0.1266|TWO_SIDED|95.0|-0.2|1.7|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||1.7|-0.2|0.1266
72505185|NCT01380093|144541478|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.6||||0.0723|TWO_SIDED|95.0|-5.3|0.2|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||0.2|-5.3|0.0723
72505186|NCT01380093|144541478|SUPERIORITY_OR_OTHER||LS Mean Difference|1.1||||0.4515|TWO_SIDED|95.0|-1.7|3.8|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||3.8|-1.7|0.4515
72505187|NCT01380093|144541478|SUPERIORITY_OR_OTHER||LS Mean Difference|3.6||||0.0121|TWO_SIDED|95.0|0.8|6.4|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||6.4|0.8|0.0121
72505188|NCT01380093|144541479|SUPERIORITY_OR_OTHER||LS Mean Difference|-11.0||||0.0059|TWO_SIDED|95.0|-18.7|-3.3|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-3.3|-18.7|0.0059
72505189|NCT01380093|144541479|SUPERIORITY_OR_OTHER||LS Mean Difference|4.2||||0.28|TWO_SIDED|95.0|-3.5|11.8|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||11.8|-3.5|0.2800
72505190|NCT01380093|144541479|SUPERIORITY_OR_OTHER||LS Mean Difference|15.1||||0.0002|TWO_SIDED|95.0|7.5|22.8|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||22.8|7.5|0.0002
72505191|NCT01380093|144541480|SUPERIORITY_OR_OTHER||LS Mean Difference|-36.7||||0.0001|TWO_SIDED|95.0|-54.8|-18.6|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-18.6|-54.8|0.0001
72505192|NCT01380093|144541480|SUPERIORITY_OR_OTHER||LS Mean Difference|13.2||||0.1488|TWO_SIDED|95.0|-4.8|31.2|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||31.2|-4.8|0.1488
72505193|NCT01380093|144541480|SUPERIORITY_OR_OTHER||LS Mean Difference|49.9|||<|0.0001|TWO_SIDED|95.0|31.8|67.9|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||67.9|31.8|<0.0001
72505194|NCT01380093|144541481|SUPERIORITY_OR_OTHER||LS Mean Difference|-60.1|||<|0.0001|TWO_SIDED|95.0|-88.5|-31.6|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-31.6|-88.5|<0.0001
72505195|NCT01380093|144541481|SUPERIORITY_OR_OTHER||LS Mean Difference|20.4||||0.1556|TWO_SIDED|95.0|-8.0|48.7|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||48.7|-8.0|0.1556
72505196|NCT01380093|144541481|SUPERIORITY_OR_OTHER||LS Mean Difference|80.4|||<|0.0001|TWO_SIDED|95.0|52.0|108.9|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||108.9|52.0|<0.0001
72505197|NCT01380093|144541482|SUPERIORITY_OR_OTHER||LS Mean Difference|-84.0||||0.0001|TWO_SIDED|95.0|-124.8|-43.2|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-43.2|-124.8|0.0001
72505198|NCT01380093|144541482|SUPERIORITY_OR_OTHER||LS Mean Difference|27.4||||0.1826|TWO_SIDED|95.0|-13.3|68.1|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||68.1|-13.3|0.1826
72505199|NCT01380093|144541482|SUPERIORITY_OR_OTHER||LS Mean Difference|111.4|||<|0.0001|TWO_SIDED|95.0|70.6|152.2|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||152.2|70.6|<0.0001
72505200|NCT01380093|144541483|SUPERIORITY_OR_OTHER||LS Mean Difference|-11.7|||<|0.0001|TWO_SIDED|95.0|-16.4|-7.0|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-7.0|-16.4|<0.0001
72505201|NCT01380093|144541483|SUPERIORITY_OR_OTHER||LS Mean Difference|4.2||||0.0811|TWO_SIDED|95.0|-0.5|8.9|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||8.9|-0.5|0.0811
72505202|NCT01380093|144541483|SUPERIORITY_OR_OTHER||LS Mean Difference|15.9|||<|0.0001|TWO_SIDED|95.0|11.1|20.6|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||20.6|11.1|<0.0001
72505203|NCT01380093|144541484|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.5||||0.0007|TWO_SIDED|95.0|-3.8|-1.1|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-1.1|-3.8|0.0007
72505204|NCT01380093|144541484|SUPERIORITY_OR_OTHER||LS Mean Difference|1.0||||0.1631|TWO_SIDED|95.0|-0.4|2.3|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||2.3|-0.4|0.1631
72505205|NCT01380093|144541484|SUPERIORITY_OR_OTHER||LS Mean Difference|3.4|||<|0.0001|TWO_SIDED|95.0|2.1|4.8|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||4.8|2.1|<0.0001
72505206|NCT01380093|144541485|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.2||||0.2117|TWO_SIDED|95.0|-3.1|0.7|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||0.7|-3.1|0.2117
72505207|NCT01380093|144541485|SUPERIORITY_OR_OTHER||LS Mean Difference|2.1||||0.0345|TWO_SIDED|95.0|0.2|4.0|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||4.0|0.2|0.0345
72505208|NCT01380093|144541485|SUPERIORITY_OR_OTHER||LS Mean Difference|3.3||||0.0011|TWO_SIDED|95.0|1.4|5.2|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||5.2|1.4|0.0011
72505209|NCT01380093|144541486|SUPERIORITY_OR_OTHER||LS Mean Difference|-12.2||||0.0002|TWO_SIDED|95.0|-18.4|-6.0|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-6.0|-18.4|0.0002
72505210|NCT01380093|144541486|SUPERIORITY_OR_OTHER||LS Mean Difference|8.4||||0.0081|TWO_SIDED|95.0|2.3|14.6|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||14.6|2.3|0.0081
72505211|NCT01380093|144541486|SUPERIORITY_OR_OTHER||LS Mean Difference|20.6|||<|0.0001|TWO_SIDED|95.0|14.4|26.8|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||26.8|14.4|<0.0001
72395270|NCT03654651|144297226|OTHER|change from baseline|Mean Difference (Final Values)|-0.4|||||TWO_SIDED|95.0|-2.9|2.1|||Mixed Models Analysis|||central systolic BP change from baseline||2.1|-2.9|
72505212|NCT01380093|144541487|SUPERIORITY_OR_OTHER||LS Mean Difference|-38.2|||<|0.0001|TWO_SIDED|95.0|-55.6|-20.8|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-20.8|-55.6|<0.0001
72395271|NCT03654651|144297226|OTHER|change from baseline|Mean Difference (Final Values)|0.5|||||TWO_SIDED|95.0|-1.5|2.6|||Mixed Models Analysis|||central diastolic BP change from baseline||2.6|-1.5|
72505213|NCT01380093|144541487|SUPERIORITY_OR_OTHER||LS Mean Difference|34.4||||0.0002|TWO_SIDED|95.0|17.0|51.7|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||51.7|17.0|0.0002
72505214|NCT01380093|144541487|SUPERIORITY_OR_OTHER||LS Mean Difference|72.6|||<|0.0001|TWO_SIDED|95.0|55.2|90.0|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||90.0|55.2|<0.0001
72565498|NCT03575871|144662361|SUPERIORITY||Difference in LS mean|-34.1|||<|0.0001|TWO_SIDED|95.0|-43.1|-25.1|||Mixed Models Analysis|||Change at Week 2: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-25.1|-43.1|<0.0001
72622595|NCT05339659|144775349|OTHER|The null hypothesis for the significance test is 0 difference in average score between arms.|Mean Difference (Final Values)|-0.14||||0.9|TWO_SIDED|95.0|-2.67|2.38|||Regression, Linear||mean difference=experimental-control|||2.38|-2.67|0.90
72622596|NCT05339659|144775350|OTHER|The null hypothesis for the significance test is 0 difference in average score between arms.|Mean Difference (Final Values)|-0.55||||0.632|TWO_SIDED|95.0|-3.03|1.93|||Regression, Linear||mean difference=experimental-control|||1.93|-3.03|0.632
72622597|NCT05339659|144775351|OTHER|The null hypothesis for the significance test is 0 difference in average score between arms.|Mean Difference (Final Values)|-1.31||||0.227|TWO_SIDED|95.0|-3.55|-0.94|||Regression, Linear||mean difference=experimental-control|||-0.94|-3.55|0.227
72622598|NCT05339659|144775352|OTHER|The null hypothesis for the significance test is 0 difference in average score between arms.|Mean Difference (Final Values)|-1.22||||0.274|TWO_SIDED|95.0|-3.58|1.15|||Regression, Linear||mean difference=experimental-control|||1.15|-3.58|0.274
72622599|NCT05339659|144775356|OTHER|The null hypothesis for the significance test is 0 difference in probability of engaging with the app component.|Risk Difference (RD)|0.04||||0.981|TWO_SIDED|95.0|-0.39|0.39|||Barnard's exact test||risk difference=experimental-control|||0.39|-0.39|0.981
72505215|NCT01380093|144541488|SUPERIORITY_OR_OTHER||LS Mean Difference|-100.3|||<|0.0001|TWO_SIDED|95.0|-142.2|-58.4|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-58.4|-142.2|<0.0001
72505216|NCT01380093|144541488|SUPERIORITY_OR_OTHER||LS Mean Difference|93.9|||<|0.0001|TWO_SIDED|95.0|52.1|135.7|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||135.7|52.1|<0.0001
72505217|NCT01380093|144541488|SUPERIORITY_OR_OTHER||LS Mean Difference|194.2|||<|0.0001|TWO_SIDED|95.0|152.3|236.1|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||236.1|152.3|<0.0001
72505218|NCT01380093|144541489|SUPERIORITY_OR_OTHER||LS Mean Difference|-147.4|||<|0.0001|TWO_SIDED|95.0|-205.1|-89.6|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-89.6|-205.1|<0.0001
72505219|NCT01380093|144541489|SUPERIORITY_OR_OTHER||LS Mean Difference|134.1|||<|0.0001|TWO_SIDED|95.0|76.5|191.7|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||191.7|76.5|<0.0001
72505220|NCT01380093|144541489|SUPERIORITY_OR_OTHER||LS Mean Difference|281.5|||<|0.0001|TWO_SIDED|95.0|223.7|339.2|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||339.2|223.7|<0.0001
72505221|NCT01380093|144541490|SUPERIORITY_OR_OTHER||LS Mean Difference|-201.4|||<|0.0001|TWO_SIDED|95.0|-279.3|-123.6|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-123.6|-279.3|<0.0001
72505222|NCT01380093|144541490|SUPERIORITY_OR_OTHER||LS Mean Difference|169.1|||<|0.0001|TWO_SIDED|95.0|91.5|246.7|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||246.7|91.5|<0.0001
72505223|NCT01380093|144541490|SUPERIORITY_OR_OTHER||LS Mean Difference|370.5|||<|0.0001|TWO_SIDED|95.0|292.7|448.4|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||448.4|292.7|<0.0001
72505224|NCT01380093|144541491|SUPERIORITY_OR_OTHER||LS Mean Difference|-16.4|||<|0.0001|TWO_SIDED|95.0|-23.8|-9.0|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-9.0|-23.8|<0.0001
72505225|NCT01380093|144541491|SUPERIORITY_OR_OTHER||LS Mean Difference|25.7|||<|0.0001|TWO_SIDED|95.0|18.3|33.1|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||33.1|18.3|<0.0001
72505226|NCT01380093|144541491|SUPERIORITY_OR_OTHER||LS Mean Difference|42.1|||<|0.0001|TWO_SIDED|95.0|34.7|49.5|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||49.5|34.7|<0.0001
72505227|NCT01380093|144541492|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.4||||0.0253|TWO_SIDED|95.0|-2.6|-0.2|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-0.2|-2.6|0.0253
72505228|NCT01380093|144541492|SUPERIORITY_OR_OTHER||LS Mean Difference|2.8|||<|0.0001|TWO_SIDED|95.0|1.6|4.0|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||4.0|1.6|<0.0001
72505229|NCT01380093|144541492|SUPERIORITY_OR_OTHER||LS Mean Difference|4.2|||<|0.0001|TWO_SIDED|95.0|3.0|5.4|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||5.4|3.0|<0.0001
72505230|NCT01380093|144541493|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.1||||0.0062|TWO_SIDED|95.0|-3.7|-0.6|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-0.6|-3.7|0.0062
72505231|NCT01380093|144541493|SUPERIORITY_OR_OTHER||LS Mean Difference|0.5||||0.4998|TWO_SIDED|95.0|-1.0|2.0|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||2.0|-1.0|0.4998
72470629|NCT04092452|144465181|SUPERIORITY||Risk Difference (RD)|8.1|STANDARD_ERROR_OF_MEAN|8.36||0.1664|TWO_SIDED|90.0|-5.7|21.8||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 8||21.8|-5.7|0.1664
72470630|NCT04092452|144465181|SUPERIORITY||Risk Difference (RD)|7.2|STANDARD_ERROR_OF_MEAN|8.1||0.1882|TWO_SIDED|90.0|-6.1|20.5||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 12||20.5|-6.1|0.1882
72470631|NCT04092452|144465181|SUPERIORITY||Risk Difference (RD)|14.9|STANDARD_ERROR_OF_MEAN|8.43||0.0423|TWO_SIDED|90.0|1.1|28.8||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 12||28.8|1.1|0.0423
72470632|NCT04092452|144465181|SUPERIORITY||Risk Difference (RD)|3.3|STANDARD_ERROR_OF_MEAN|7.9||0.3396|TWO_SIDED|90.0|-9.7|16.3||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 12||16.3|-9.7|0.3396
72470633|NCT04092452|144465181|SUPERIORITY||Risk Difference (RD)|2.7|STANDARD_ERROR_OF_MEAN|7.35||0.3584|TWO_SIDED|90.0|-9.4|14.8||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 16||14.8|-9.4|0.3584
72470634|NCT04092452|144465181|SUPERIORITY||Risk Difference (RD)|14.9|STANDARD_ERROR_OF_MEAN|8.17||0.0367|TWO_SIDED|90.0|1.5|28.3||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 16||28.3|1.5|0.0367
72505232|NCT01380093|144541493|SUPERIORITY_OR_OTHER||LS Mean Difference|2.7||||0.0008|TWO_SIDED|95.0|1.1|4.2|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||4.2|1.1|0.0008
72505233|NCT01380093|144541494|SUPERIORITY_OR_OTHER||LS Mean Difference|-7.0||||0.0009|TWO_SIDED|95.0|-11.1|-3.0|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-3.0|-11.1|0.0009
72505234|NCT01380093|144541494|SUPERIORITY_OR_OTHER||LS Mean Difference|2.2||||0.2693|TWO_SIDED|95.0|-1.8|6.3|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||6.3|-1.8|0.2693
72470635|NCT04092452|144465181|SUPERIORITY||Risk Difference (RD)|5.2|STANDARD_ERROR_OF_MEAN|7.65||0.2486|TWO_SIDED|90.0|-7.4|17.8||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 16||17.8|-7.4|0.2486
72470636|NCT04092452|144465187|SUPERIORITY||Risk Difference (RD)|-0.2|STANDARD_ERROR_OF_MEAN|0.295|||TWO_SIDED|90.0|-0.69|0.29||||||Week 1-HSS0101-Pain At It's Worst||0.29|-0.69|
72470637|NCT04092452|144465187|SUPERIORITY||Risk Difference (RD)|-0.48|STANDARD_ERROR_OF_MEAN|0.287|||TWO_SIDED|90.0|-0.96|-0.01||||||Week 1-HSS0101-Pain At It's Worst||-0.01|-0.96|
72505235|NCT01380093|144541494|SUPERIORITY_OR_OTHER||LS Mean Difference|9.3|||<|0.0001|TWO_SIDED|95.0|5.3|13.3|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||13.3|5.3|<0.0001
72505236|NCT01380093|144541495|SUPERIORITY_OR_OTHER||LS Mean Difference|-16.2||||0.0042|TWO_SIDED|95.0|-27.2|-5.3|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-5.3|-27.2|0.0042
72470638|NCT04092452|144465187|SUPERIORITY||Risk Difference (RD)|-0.42|STANDARD_ERROR_OF_MEAN|0.295|||TWO_SIDED|90.0|-0.91|0.06||||||Week 1-HSS0101-Pain At It's Worst||0.06|-0.91|
72470639|NCT04092452|144465187|SUPERIORITY||Risk Difference (RD)|-0.3|STANDARD_ERROR_OF_MEAN|0.392|||TWO_SIDED|90.0|-0.95|0.35||||||Week 2-HSS0101-Pain At It's Worst||0.35|-0.95|
72470640|NCT04092452|144465187|SUPERIORITY||Risk Difference (RD)|-0.71|STANDARD_ERROR_OF_MEAN|0.377|||TWO_SIDED|90.0|-1.33|-0.08||||||Week 2-HSS0101-Pain At It's Worst||-0.08|-1.33|
72470641|NCT04092452|144465187|SUPERIORITY||Risk Difference (RD)|-0.57|STANDARD_ERROR_OF_MEAN|0.391|||TWO_SIDED|90.0|-1.21|0.08||||||Week 2-HSS0101-Pain At It's Worst||0.08|-1.21|
72470642|NCT04092452|144465187|SUPERIORITY||Risk Difference (RD)|0.26|STANDARD_ERROR_OF_MEAN|0.481|||TWO_SIDED|90.0|-0.54|1.05||||||Week 4-HSS0101-Pain At It's Worst||1.05|-0.54|
72470643|NCT04092452|144465187|SUPERIORITY||Risk Difference (RD)|-0.39|STANDARD_ERROR_OF_MEAN|0.458|||TWO_SIDED|90.0|-1.15|0.37||||||Week 4-HSS0101-Pain At It's Worst||0.37|-1.15|
72470644|NCT04092452|144465187|SUPERIORITY||Risk Difference (RD)|-0.06|STANDARD_ERROR_OF_MEAN|0.478|||TWO_SIDED|90.0|-0.85|0.73||||||Week 4-HSS0101-Pain At It's Worst||0.73|-0.85|
72470645|NCT04092452|144465187|SUPERIORITY||Risk Difference (RD)|0.62|STANDARD_ERROR_OF_MEAN|0.524|||TWO_SIDED|90.0|-0.24|1.49||||||Week 6-HSS0101-Pain At It's Worst||1.49|-0.24|
72470646|NCT04092452|144465187|SUPERIORITY||Risk Difference (RD)|-0.19|STANDARD_ERROR_OF_MEAN|0.505|||TWO_SIDED|90.0|-1.03|0.64||||||Week 6-HSS0101-Pain At It's Worst||0.64|-1.03|
72470647|NCT04092452|144465187|SUPERIORITY||Risk Difference (RD)|0.21|STANDARD_ERROR_OF_MEAN|0.526|||TWO_SIDED|90.0|-0.66|1.08||||||Week 6-HSS0101-Pain At It's Worst||1.08|-0.66|
72470648|NCT04092452|144465187|SUPERIORITY||Risk Difference (RD)|0.24|STANDARD_ERROR_OF_MEAN|0.558|||TWO_SIDED|90.0|-0.69|1.16||||||Week 8-HSS0101-Pain At It's Worst||1.16|-0.69|
72470649|NCT04092452|144465187|SUPERIORITY||Risk Difference (RD)|-0.32|STANDARD_ERROR_OF_MEAN|0.539|||TWO_SIDED|90.0|-1.21|0.57||||||Week 8-HSS0101-Pain At It's Worst||0.57|-1.21|
72505237|NCT01380093|144541495|SUPERIORITY_OR_OTHER||LS Mean Difference|8.7||||0.1139|TWO_SIDED|95.0|-2.2|19.6|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||19.6|-2.2|0.1139
72505238|NCT01380093|144541495|SUPERIORITY_OR_OTHER||LS Mean Difference|25.0|||<|0.0001|TWO_SIDED|95.0|14.1|35.9|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||35.9|14.1|<0.0001
72565499|NCT03575871|144662361|SUPERIORITY||Difference in LS mean|-29.7|||<|0.0001|TWO_SIDED|95.0|-39.0|-20.4|||Mixed Models Analysis|||Change at Week 4: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-20.4|-39.0|<0.0001
72565500|NCT03575871|144662361|SUPERIORITY||Difference in LS mean|-40.5|||<|0.0001|TWO_SIDED|95.0|-49.8|-31.1|||Mixed Models Analysis|||Change at Week 4: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-31.1|-49.8|<0.0001
72565501|NCT03575871|144662361|SUPERIORITY||Difference in LS mean|-32.9|||<|0.0001|TWO_SIDED|95.0|-44.6|-21.2|||Mixed Models Analysis|||Change at Week 8: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-21.2|-44.6|<0.0001
72565502|NCT03575871|144662361|SUPERIORITY||Difference in LS mean|-40.6|||<|0.0001|TWO_SIDED|95.0|-52.2|-28.9|||Mixed Models Analysis|||Change at Week 8: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-28.9|-52.2|<0.0001
72565503|NCT03575871|144662361|SUPERIORITY||Difference in LS mean|-39.6|||<|0.0001|TWO_SIDED|95.0|-51.8|-27.4|||Mixed Models Analysis|||Change at Week 12: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-27.4|-51.8|<0.0001
72565504|NCT03575871|144662361|SUPERIORITY||Difference in LS mean|-48.2|||<|0.0001|TWO_SIDED|95.0|-60.4|-36.0|||Mixed Models Analysis|||Change at Week 12: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-36.0|-60.4|<0.0001
72565505|NCT03575871|144662362|SUPERIORITY||Difference in Percentage|1.9||||0.2353|TWO_SIDED|95.0|-2.2|6.0||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||6.0|-2.2|0.2353
72565506|NCT03575871|144662362|SUPERIORITY||Difference in Percentage|5.8||||0.0332|TWO_SIDED|95.0|0.8|10.8||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||10.8|0.8|0.0332
72622600|NCT05339659|144775357|OTHER|The null hypothesis for the significance test is 0 difference in probability of engaging with the app component.|Risk Difference (RD)|-0.01||||0.845|TWO_SIDED|95.0|-0.49|0.43|||Barnard's exact test||risk difference=experimental-control|||0.43|-0.49|0.845
72395272|NCT03654651|144297226|OTHER|change from baseline|Mean Difference (Final Values)|-0.4|||||TWO_SIDED|95.0|-2.4|1.6|||Mixed Models Analysis|||central diastolic BP change from baseline||1.6|-2.4|
72395273|NCT03654651|144297227|SUPERIORITY||Mean Difference (Final Values)|0.2|||||TWO_SIDED|95.0|-0.1|0.5|||Mixed Models Analysis|||||0.5|-0.1|
72395274|NCT03654651|144297227|OTHER|change from baseline|Mean Difference (Final Values)|0.3|||||TWO_SIDED|95.0|0.1|0.6|||Mixed Models Analysis|||||0.6|0.1|
72565507|NCT03575871|144662362|SUPERIORITY||Difference in Percentage|6.5||||0.0227|TWO_SIDED|95.0|1.4|11.6||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||11.6|1.4|0.0227
72565508|NCT03575871|144662362|SUPERIORITY||Difference in Percentage|16.8||||0.0001|TWO_SIDED|95.0|10.1|23.5||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||23.5|10.1|0.0001
72565509|NCT03575871|144662362|SUPERIORITY||Difference in Percentage|14.5||||0.0008|TWO_SIDED|95.0|7.7|21.3||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||21.3|7.7|0.0008
72565510|NCT03575871|144662362|SUPERIORITY||Difference in Percentage|25.8|||<|0.0001|TWO_SIDED|95.0|18.1|33.4||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||33.4|18.1|<0.0001
72565511|NCT03575871|144662362|SUPERIORITY||Difference in Percentage|18.5||||0.0003|TWO_SIDED|95.0|10.5|26.5||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||26.5|10.5|0.0003
72565512|NCT03575871|144662362|SUPERIORITY||Difference in Percentage|30.2|||<|0.0001|TWO_SIDED|95.0|21.4|39.0||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||39.0|21.4|<0.0001
72622601|NCT05339659|144775358|OTHER|The null hypothesis for the significance test is 0 difference in probability of engaging with the app component.|Risk Difference (RD)|-0.05||||0.56|TWO_SIDED|95.0|-0.47|0.28|||Barnard's exact test||||risk difference=experimental-control|0.28|-0.47|0.560
72395275|NCT03654651|144297227|OTHER|change from baseline|Mean Difference (Final Values)|0.1|||||TWO_SIDED|95.0|-0.1|0.3|||Mixed Models Analysis|||||0.3|-0.1|
72395276|NCT03654651|144297228|SUPERIORITY||Mean Difference (Final Values)|-1.4|||||TWO_SIDED|95.0|-5.9|3.3|||Mixed Models Analysis|||||3.3|-5.9|
72395277|NCT03654651|144297228|OTHER|change from baseline|Mean Difference (Final Values)|-0.4|||||TWO_SIDED|95.0|-3.7|2.9|||Mixed Models Analysis|||||2.9|-3.7|
72470650|NCT04092452|144465187|SUPERIORITY||Risk Difference (RD)|0.44|STANDARD_ERROR_OF_MEAN|0.565|||TWO_SIDED|90.0|-0.49|1.38||||||Week 8-HSS0101-Pain At It's Worst||1.38|-0.49|
72470651|NCT04092452|144465187|SUPERIORITY||Risk Difference (RD)|0.16|STANDARD_ERROR_OF_MEAN|0.578|||TWO_SIDED|90.0|-0.79|1.12||||||Week 12-HSS0101-Pain At It's Worst||1.12|-0.79|
72470652|NCT04092452|144465187|SUPERIORITY||Risk Difference (RD)|-0.68|STANDARD_ERROR_OF_MEAN|0.55|||TWO_SIDED|90.0|-1.59|0.23||||||Week 12-HSS0101-Pain At It's Worst||0.23|-1.59|
72470653|NCT04092452|144465187|SUPERIORITY||Risk Difference (RD)|0.08|STANDARD_ERROR_OF_MEAN|0.576|||TWO_SIDED|90.0|-0.88|1.03||||||Week 12-HSS0101-Pain At It's Worst||1.03|-0.88|
72470654|NCT04092452|144465187|SUPERIORITY||Risk Difference (RD)|0.08|STANDARD_ERROR_OF_MEAN|0.631|||TWO_SIDED|90.0|-0.96|1.13||||||Week 16-HSS0101-Pain At It's Worst||1.13|-0.96|
72470655|NCT04092452|144465187|SUPERIORITY||Risk Difference (RD)|-1.25|STANDARD_ERROR_OF_MEAN|0.6|||TWO_SIDED|90.0|-2.24|-0.25||||||Week 16-HSS0101-Pain At It's Worst||-0.25|-2.24|
72470656|NCT04092452|144465187|SUPERIORITY||Risk Difference (RD)|-0.91|STANDARD_ERROR_OF_MEAN|0.628|||TWO_SIDED|90.0|-1.95|0.13||||||Week 16-HSS0101-Pain At It's Worst||0.13|-1.95|
72470657|NCT04092452|144465187|SUPERIORITY||Risk Difference (RD)|0.01|STANDARD_ERROR_OF_MEAN|0.286|||TWO_SIDED|90.0|-0.47|0.48||||||Week 1-HSS0102-Tenderness At It's Worst||0.48|-0.47|
72470658|NCT04092452|144465187|SUPERIORITY||Risk Difference (RD)|-0.28|STANDARD_ERROR_OF_MEAN|0.278|||TWO_SIDED|90.0|-0.75|0.18||||||Week 1-HSS0102-Tenderness At It's Worst||0.18|-0.75|
72505239|NCT01380093|144541496|SUPERIORITY_OR_OTHER||LS Mean Difference|-34.9|||<|0.0001|TWO_SIDED|95.0|-42.1|-27.7||p-value adjusted for multiple comparisons with Hochberg adjustment. At least one primary outcome for each of drug liking and high was required to be significant with adjusted p-value less than or equal to 0.05.|Mixed Models Analysis|||LS mean and 95% CI were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-27.7|-42.1|<0.0001
72470659|NCT04092452|144465187|SUPERIORITY||Risk Difference (RD)|-0.31|STANDARD_ERROR_OF_MEAN|0.286|||TWO_SIDED|90.0|-0.78|0.17||||||Week 1-HSS0102-Tenderness At It's Worst||0.17|-0.78|
72470660|NCT04092452|144465187|SUPERIORITY||Risk Difference (RD)|-0.22|STANDARD_ERROR_OF_MEAN|0.361|||TWO_SIDED|90.0|-0.81|0.38||||||Week 2-HSS0102-Tenderness At It's Worst||0.38|-0.81|
72470661|NCT04092452|144465187|SUPERIORITY||Risk Difference (RD)|-0.4|STANDARD_ERROR_OF_MEAN|0.347|||TWO_SIDED|90.0|-0.97|0.18||||||Week 2-HSS0102-Tenderness At It's Worst||0.18|-0.97|
72505240|NCT01380093|144541496|SUPERIORITY_OR_OTHER||LS Mean Difference|27.2|||<|0.0001|TWO_SIDED|95.0|20.1|34.4||p-value adjusted for multiple comparisons with Hochberg adjustment.|Mixed Models Analysis|||LS mean and 95% CI were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||34.4|20.1|<0.0001
72505241|NCT01380093|144541496|SUPERIORITY_OR_OTHER||LS Mean Difference|62.1|||<|0.0001|TWO_SIDED|95.0|54.9|69.4||p-value adjusted for multiple comparisons with Hochberg adjustment.|Mixed Models Analysis|||LS mean and 95% CI were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||69.4|54.9|<0.0001
72622602|NCT05339659|144775359|OTHER|The null hypothesis for the significance test is 0 difference in probability of engaging with the app component.|Risk Difference (RD)|0.04||||0.981|TWO_SIDED|95.0|-0.39|0.39|||Barnard's exact test||risk difference=experimental-control|||0.39|-0.39|0.981
72470662|NCT04092452|144465187|SUPERIORITY||Risk Difference (RD)|-0.46|STANDARD_ERROR_OF_MEAN|0.36|||TWO_SIDED|90.0|-1.05|0.14||||||Week 2-HSS0102-Tenderness At It's Worst||0.14|-1.05|
72470663|NCT04092452|144465187|SUPERIORITY||Risk Difference (RD)|0.22|STANDARD_ERROR_OF_MEAN|0.471|||TWO_SIDED|90.0|-0.56|1.0||||||Week 4-HSS0102-Tenderness At It's Worst||1.00|-0.56|
72470664|NCT04092452|144465187|SUPERIORITY||Risk Difference (RD)|-0.25|STANDARD_ERROR_OF_MEAN|0.448|||TWO_SIDED|90.0|-0.99|0.49||||||Week 4-HSS0102-Tenderness At It's Worst||0.49|-0.99|
72470665|NCT04092452|144465187|SUPERIORITY||Risk Difference (RD)|-0.11|STANDARD_ERROR_OF_MEAN|0.468|||TWO_SIDED|90.0|-0.88|0.67||||||Week 4-HSS0102-Tenderness At It's Worst||0.67|-0.88|
72470666|NCT04092452|144465187|SUPERIORITY||Risk Difference (RD)|0.48|STANDARD_ERROR_OF_MEAN|0.52|||TWO_SIDED|90.0|-0.38|1.34||||||Week 6-HSS0102-Tenderness At It's Worst||1.34|-0.38|
72470667|NCT04092452|144465187|SUPERIORITY||Risk Difference (RD)|-0.23|STANDARD_ERROR_OF_MEAN|0.501|||TWO_SIDED|90.0|-1.06|0.6||||||Week 6-HSS0102-Tenderness At It's Worst||0.60|-1.06|
72470668|NCT04092452|144465187|SUPERIORITY||Risk Difference (RD)|0.01|STANDARD_ERROR_OF_MEAN|0.523|||TWO_SIDED|90.0|-0.86|0.87||||||Week 6-HSS0102-Tenderness At It's Worst||0.87|-0.86|
72470669|NCT04092452|144465187|SUPERIORITY||Risk Difference (RD)|0.09|STANDARD_ERROR_OF_MEAN|0.542|||TWO_SIDED|90.0|-0.81|0.99||||||Week 8-HSS0102-Tenderness At It's Worst||0.99|-0.81|
72470670|NCT04092452|144465187|SUPERIORITY||Risk Difference (RD)|-0.25|STANDARD_ERROR_OF_MEAN|0.523|||TWO_SIDED|90.0|-1.11|0.62||||||Week 8-HSS0102-Tenderness At It's Worst||0.62|-1.11|
72470671|NCT04092452|144465187|SUPERIORITY||Risk Difference (RD)|0.35|STANDARD_ERROR_OF_MEAN|0.549|||TWO_SIDED|90.0|-0.56|1.25||||||Week 8-HSS0102-Tenderness At It's Worst||1.25|-0.56|
72470672|NCT04092452|144465187|SUPERIORITY||Risk Difference (RD)|0.05|STANDARD_ERROR_OF_MEAN|0.554|||TWO_SIDED|90.0|-0.87|0.97||||||Week 12-HSS0102-Tenderness At It's Worst||0.97|-0.87|
72470673|NCT04092452|144465187|SUPERIORITY||Risk Difference (RD)|-0.49|STANDARD_ERROR_OF_MEAN|0.527|||TWO_SIDED|90.0|-1.36|0.38||||||Week 12-HSS0102-Tenderness At It's Worst||0.38|-1.36|
72470674|NCT04092452|144465187|SUPERIORITY||Risk Difference (RD)|0.02|STANDARD_ERROR_OF_MEAN|0.552|||TWO_SIDED|90.0|-0.9|0.93||||||Week 12-HSS0102-Tenderness At It's Worst||0.93|-0.90|
72470675|NCT04092452|144465187|SUPERIORITY||Risk Difference (RD)|0.04|STANDARD_ERROR_OF_MEAN|0.606|||TWO_SIDED|90.0|-0.96|1.04||||||Week 16-HSS0102-Tenderness At It's Worst||1.04|-0.96|
72470676|NCT04092452|144465187|SUPERIORITY||Risk Difference (RD)|-1.24|STANDARD_ERROR_OF_MEAN|0.577|||TWO_SIDED|90.0|-2.19|-0.29||||||Week 16-HSS0102-Tenderness At It's Worst||-0.29|-2.19|
72470677|NCT04092452|144465187|SUPERIORITY||Risk Difference (RD)|-1.11|STANDARD_ERROR_OF_MEAN|0.603|||TWO_SIDED|90.0|-2.11|-0.11||||||Week 16-HSS0102-Tenderness At It's Worst||-0.11|-2.11|
72470678|NCT04092452|144465187|SUPERIORITY||Risk Difference (RD)|-0.1|STANDARD_ERROR_OF_MEAN|0.284|||TWO_SIDED|90.0|-0.57|0.37||||||Week 1-HSS0103-Swelling At It's Worst||0.37|-0.57|
72470679|NCT04092452|144465187|SUPERIORITY||Risk Difference (RD)|-0.23|STANDARD_ERROR_OF_MEAN|0.278|||TWO_SIDED|90.0|-0.69|0.22||||||Week 1-HSS0103-Swelling At It's Worst||0.22|-0.69|
72470680|NCT04092452|144465187|SUPERIORITY||Risk Difference (RD)|-0.47|STANDARD_ERROR_OF_MEAN|0.285|||TWO_SIDED|90.0|-0.94|0.01||||||Week 1-HSS0103-Swelling At It's Worst||0.01|-0.94|
72565513|NCT03575871|144662363|SUPERIORITY||Difference in Percentage|12.7||||0.0011|TWO_SIDED|95.0|6.5|18.9||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||18.9|6.5|0.0011
72565514|NCT03575871|144662363|SUPERIORITY||Difference in Percentage|32.6|||<|0.0001|TWO_SIDED|95.0|24.6|40.6||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||40.6|24.6|<0.0001
72565515|NCT03575871|144662363|SUPERIORITY||Difference in Percentage|28.3|||<|0.0001|TWO_SIDED|95.0|18.5|38.2||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||38.2|18.5|<0.0001
72565516|NCT03575871|144662363|SUPERIORITY||Difference in Percentage|52.8|||<|0.0001|TWO_SIDED|95.0|43.2|62.5||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||62.5|43.2|<0.0001
72565517|NCT03575871|144662363|SUPERIORITY||Difference in Percentage|28.0|||<|0.0001|TWO_SIDED|95.0|17.0|39.0||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||39.0|17.0|<0.0001
72565518|NCT03575871|144662363|SUPERIORITY||Difference in Percentage|46.1|||<|0.0001|TWO_SIDED|95.0|35.2|57.1||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||57.1|35.2|<0.0001
72565519|NCT03575871|144662363|SUPERIORITY||Difference in Percentage|36.2|||<|0.0001|TWO_SIDED|95.0|25.4|47.1||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||47.1|25.4|<0.0001
72565520|NCT03575871|144662363|SUPERIORITY||Difference in Percentage|49.6|||<|0.0001|TWO_SIDED|95.0|38.9|60.3||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||60.3|38.9|<0.0001
72395278|NCT03654651|144297228|OTHER|change from baseline|Mean Difference (Final Values)|0.2|||||TWO_SIDED|95.0|-4.0|4.3|||Mixed Models Analysis|||||4.3|-4.0|
72622603|NCT05339659|144775360|OTHER|The null hypothesis for the significance test is 0 difference in probability of engaging with the app component.|Risk Difference (RD)|-0.13||||0.632|TWO_SIDED|95.0|-0.49|0.34|||Barnard's exact test||risk difference=experimental-control|||0.34|-0.49|0.632
72395279|NCT03654651|144297229|SUPERIORITY||Mean Difference (Final Values)|4.3|||||TWO_SIDED|95.0|-1.4|9.8|||Mixed Models Analysis|||||9.8|-1.4|
72395280|NCT03654651|144297229|OTHER|change from baseline|Mean Difference (Final Values)|2.4|||||TWO_SIDED|95.0|-2.1|6.9|||Mixed Models Analysis|||||6.9|-2.1|
72565521|NCT03575871|144662364|SUPERIORITY||Difference in Percentage|1.9||||0.2261|TWO_SIDED|95.0|-2.2|6.0||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||6.0|-2.2|0.2261
72565522|NCT03575871|144662364|SUPERIORITY||Difference in Percentage|5.2||||0.0451|TWO_SIDED|95.0|0.3|10.0||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||10.0|0.3|0.0451
72565523|NCT03575871|144662364|SUPERIORITY||Difference in Percentage|7.0||||0.0171|TWO_SIDED|95.0|1.8|12.3||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||12.3|1.8|0.0171
72565524|NCT03575871|144662364|SUPERIORITY||Difference in Percentage|17.7|||<|0.0001|TWO_SIDED|95.0|10.9|24.5||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||24.5|10.9|<0.0001
72565525|NCT03575871|144662364|SUPERIORITY||Difference in Percentage|11.5||||0.0018|TWO_SIDED|95.0|5.5|17.5||P-value was adjusted by randomization strata (baseline disease severity and age category)|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||17.5|5.5|0.0018
72622604|NCT05339659|144775361|OTHER|The null hypothesis for the significance test is 0 difference in probability of engaging with the app component.|Risk Difference (RD)|-0.03|||>|0.999|TWO_SIDED|95.0|-0.48|0.45|||Barnard's exact test||risk difference=experimental-control|||0.45|-0.48|>0.999
72622605|NCT00561821|144775363|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA|||||||<0.0001
72622606|NCT00561821|144775363|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA|||||||<0.0001
72395281|NCT03654651|144297229|OTHER|change from baseline|Mean Difference (Final Values)|-2.3|||||TWO_SIDED|95.0|-6.8|2.2|||Mixed Models Analysis|||||2.2|-6.8|
72395282|NCT03654651|144297230|SUPERIORITY||Mean Difference (Final Values)|0.0|||||TWO_SIDED|95.0|-2.3|2.3|||Mixed Models Analysis|||||2.3|-2.3|
72395283|NCT03654651|144297230|OTHER|change from baseline|Mean Difference (Final Values)|0.6|||||TWO_SIDED|95.0|-0.6|1.8|||Mixed Models Analysis|||||1.8|-0.6|
72565526|NCT03575871|144662364|SUPERIORITY||Difference in Percentage|25.7|||<|0.0001|TWO_SIDED|95.0|18.3|33.1||P-value was adjusted by randomization strata (baseline disease severity and age category)|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||33.1|18.3|<0.0001
72565527|NCT03575871|144662364|SUPERIORITY||Difference in Percentage|16.2||||0.0005|TWO_SIDED|95.0|8.8|23.6||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||23.6|8.8|0.0005
72565528|NCT03575871|144662364|SUPERIORITY||Difference in Percentage|27.6|||<|0.0001|TWO_SIDED|95.0|19.3|35.8||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||35.8|19.3|<0.0001
72565529|NCT03575871|144662365|SUPERIORITY||Difference in LS mean|-1.7|||<|0.0001|TWO_SIDED|95.0|-2.3|-1.1|||Mixed Models Analysis|||Week 2: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category), baseline value and an unstructured covariance matrix.||-1.1|-2.3|<0.0001
72565530|NCT03575871|144662365|SUPERIORITY||Difference in LS mean|-2.9|||<|0.0001|TWO_SIDED|95.0|-3.5|-2.3|||Mixed Models Analysis|||Week 2: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category), baseline value and an unstructured covariance matrix.||-2.3|-3.5|<0.0001
72565531|NCT03575871|144662365|SUPERIORITY||Difference in LS mean|-1.9|||<|0.0001|TWO_SIDED|95.0|-2.6|-1.3|||Mixed Models Analysis|||Week 4: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category), baseline value and an unstructured covariance matrix.||-1.3|-2.6|<0.0001
72565532|NCT03575871|144662365|SUPERIORITY||Difference in LS mean|-3.1|||<|0.0001|TWO_SIDED|95.0|-3.8|-2.5|||Mixed Models Analysis|||Week 4: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category), baseline value and an unstructured covariance matrix.||-2.5|-3.8|<0.0001
72565533|NCT03575871|144662365|SUPERIORITY||Difference in LS mean|-1.6|||<|0.0001|TWO_SIDED|95.0|-2.3|-0.9|||Mixed Models Analysis|||Week 8: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category), baseline value and an unstructured covariance matrix.||-0.9|-2.3|<0.0001
72622607|NCT00561821|144775363|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA|||||||<0.0001
72622608|NCT00561821|144775364|SUPERIORITY_OR_OTHER|||||||0.0146||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA|||||||0.0146
72395284|NCT03654651|144297230|OTHER|change from baseline|Mean Difference (Final Values)|0.6|||||TWO_SIDED|95.0|-1.6|2.3|||Mixed Models Analysis|||||2.3|-1.6|
72565534|NCT03575871|144662365|SUPERIORITY||Difference in LS mean|-2.6|||<|0.0001|TWO_SIDED|95.0|-3.3|-1.9|||Mixed Models Analysis|||Week 8: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category), baseline value and an unstructured covariance matrix.||-1.9|-3.3|<0.0001
72565535|NCT03575871|144662365|SUPERIORITY||Difference in LS mean|-1.4||||0.0006|TWO_SIDED|95.0|-2.2|-0.6|||Mixed Models Analysis|||Week 12: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category), baseline value and an unstructured covariance matrix.||-0.6|-2.2|0.0006
72565536|NCT03575871|144662365|SUPERIORITY||Difference in LS mean|-2.2|||<|0.0001|TWO_SIDED|95.0|-3.0|-1.4|||Mixed Models Analysis|||Week 12: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category), baseline value and an unstructured covariance matrix.||-1.4|-3.0|<0.0001
72565537|NCT03575871|144662366|SUPERIORITY||Difference in LS mean|-1.4|||<|0.0001|TWO_SIDED|95.0|-2.0|-0.8|||Mixed Models Analysis|||Week 2: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category), baseline value and an unstructured covariance matrix.||-0.8|-2.0|<0.0001
72565538|NCT03575871|144662366|SUPERIORITY||Difference in LS mean|-2.4|||<|0.0001|TWO_SIDED|95.0|-3.0|-1.8|||Mixed Models Analysis|||Week 2: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category), baseline value and an unstructured covariance matrix.||-1.8|-3.0|<0.0001
72622609|NCT00561821|144775364|SUPERIORITY_OR_OTHER|||||||0.0234||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA|||||||0.0234
72622610|NCT00561821|144775364|SUPERIORITY_OR_OTHER|||||||0.0102||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA|||||||0.0102
72565539|NCT03575871|144662366|SUPERIORITY||Difference in LS mean|-1.8|||<|0.0001|TWO_SIDED|95.0|-2.4|-1.2|||Mixed Models Analysis|||Week 4: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category), baseline value and an unstructured covariance matrix.||-1.2|-2.4|<0.0001
72565540|NCT03575871|144662366|SUPERIORITY||Difference in LS mean|-3.0|||<|0.0001|TWO_SIDED|95.0|-3.6|-2.3|||Mixed Models Analysis|||Week 4: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category), baseline value and an unstructured covariance matrix.||-2.3|-3.6|<0.0001
72622611|NCT00561821|144775365|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA|||||||<0.0001
72622612|NCT00561821|144775365|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA|||||||<0.0001
72470681|NCT04092452|144465187|SUPERIORITY||Risk Difference (RD)|-0.24|STANDARD_ERROR_OF_MEAN|0.357|||TWO_SIDED|90.0|-0.83|0.35||||||Week 2-HSS0103-Swelling At It's Worst||0.35|-0.83|
72470682|NCT04092452|144465187|SUPERIORITY||Risk Difference (RD)|-0.46|STANDARD_ERROR_OF_MEAN|0.345|||TWO_SIDED|90.0|-1.03|0.11||||||Week 2-HSS0103-Swelling At It's Worst||0.11|-1.03|
72470683|NCT04092452|144465187|SUPERIORITY||Risk Difference (RD)|-0.4|STANDARD_ERROR_OF_MEAN|0.357|||TWO_SIDED|90.0|-0.99|0.19||||||Week 2-HSS0103-Swelling At It's Worst||0.19|-0.99|
72470684|NCT04092452|144465187|SUPERIORITY||Risk Difference (RD)|0.16|STANDARD_ERROR_OF_MEAN|0.446|||TWO_SIDED|90.0|-0.58|0.9||||||Week 4-HSS0103-Swelling At It's Worst||0.90|-0.58|
72470685|NCT04092452|144465187|SUPERIORITY||Risk Difference (RD)|-0.17|STANDARD_ERROR_OF_MEAN|0.424|||TWO_SIDED|90.0|-0.87|0.53||||||Week 4-HSS0103-Swelling At It's Worst||0.53|-0.87|
72470686|NCT04092452|144465187|SUPERIORITY||Risk Difference (RD)|0.09|STANDARD_ERROR_OF_MEAN|0.443|||TWO_SIDED|90.0|-0.65|0.82||||||Week 4-HSS0103-Swelling At It's Worst||0.82|-0.65|
72470687|NCT04092452|144465187|SUPERIORITY||Risk Difference (RD)|0.7|STANDARD_ERROR_OF_MEAN|0.51|||TWO_SIDED|90.0|-0.15|1.54||||||Week 6-HSS0103-Swelling At It's Worst||1.54|-0.15|
72470688|NCT04092452|144465187|SUPERIORITY||Risk Difference (RD)|-0.02|STANDARD_ERROR_OF_MEAN|0.493|||TWO_SIDED|90.0|-0.83|0.8||||||Week 6-HSS0103-Swelling At It's Worst||0.80|-0.83|
72470689|NCT04092452|144465187|SUPERIORITY||Risk Difference (RD)|0.23|STANDARD_ERROR_OF_MEAN|0.513|||TWO_SIDED|90.0|-0.62|1.08||||||Week 6-HSS0103-Swelling At It's Worst||1.08|-0.62|
72565541|NCT03575871|144662366|SUPERIORITY||Difference in LS mean|-1.6|||<|0.0001|TWO_SIDED|95.0|-2.3|-0.9|||Mixed Models Analysis|||Week 8: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category), baseline value and an unstructured covariance matrix.||-0.9|-2.3|<0.0001
72470690|NCT04092452|144465187|SUPERIORITY||Risk Difference (RD)|0.29|STANDARD_ERROR_OF_MEAN|0.507|||TWO_SIDED|90.0|-0.55|1.13||||||Week 8-HSS0103-Swelling At It's Worst||1.13|-0.55|
72470691|NCT04092452|144465187|SUPERIORITY||Risk Difference (RD)|0.0|STANDARD_ERROR_OF_MEAN|0.489|||TWO_SIDED|90.0|-0.81|0.81||||||Week 8-HSS0103-Swelling At It's Worst||0.81|-0.81|
72470692|NCT04092452|144465187|SUPERIORITY||Risk Difference (RD)|0.5|STANDARD_ERROR_OF_MEAN|0.514|||TWO_SIDED|90.0|-0.35|1.35||||||Week 8-HSS0103-Swelling At It's Worst||1.35|-0.35|
72470693|NCT04092452|144465187|SUPERIORITY||Risk Difference (RD)|0.07|STANDARD_ERROR_OF_MEAN|0.532|||TWO_SIDED|90.0|-0.81|0.95||||||Week 12-HSS0103-Swelling At It's Worst||0.95|-0.81|
72470694|NCT04092452|144465187|SUPERIORITY||Risk Difference (RD)|-0.47|STANDARD_ERROR_OF_MEAN|0.505|||TWO_SIDED|90.0|-1.3|0.37||||||Week 12-HSS0103-Swelling At It's Worst||0.37|-1.30|
72470695|NCT04092452|144465187|SUPERIORITY||Risk Difference (RD)|-0.04|STANDARD_ERROR_OF_MEAN|0.53|||TWO_SIDED|90.0|-0.92|0.84||||||Week 12-HSS0103-Swelling At It's Worst||0.84|-0.92|
72470696|NCT04092452|144465187|SUPERIORITY||Risk Difference (RD)|0.23|STANDARD_ERROR_OF_MEAN|0.589|||TWO_SIDED|90.0|-0.75|1.2||||||Week 16-HSS0103-Swelling At It's Worst||1.20|-0.75|
72470697|NCT04092452|144465187|SUPERIORITY||Risk Difference (RD)|-1.06|STANDARD_ERROR_OF_MEAN|0.561|||TWO_SIDED|90.0|-1.99|-0.13||||||Week 16-HSS0103-Swelling At It's Worst||-0.13|-1.99|
72470698|NCT04092452|144465187|SUPERIORITY||Risk Difference (RD)|-1.02|STANDARD_ERROR_OF_MEAN|0.586|||TWO_SIDED|90.0|-1.99|-0.05||||||Week 16-HSS0103-Swelling At It's Worst||-0.05|-1.99|
72470699|NCT04092452|144465187|SUPERIORITY||Risk Difference (RD)|0.16|STANDARD_ERROR_OF_MEAN|0.262|||TWO_SIDED|90.0|-0.27|0.59||||||Week 1-HSS0104-Tiredness At It's Worst||0.59|-0.27|
72470700|NCT04092452|144465187|SUPERIORITY||Risk Difference (RD)|-0.57|STANDARD_ERROR_OF_MEAN|0.255|||TWO_SIDED|90.0|-0.99|-0.15||||||Week 1-HSS0104-Tiredness At It's Worst||-0.15|-0.99|
72470701|NCT04092452|144465187|SUPERIORITY||Risk Difference (RD)|0.09|STANDARD_ERROR_OF_MEAN|0.262|||TWO_SIDED|90.0|-0.35|0.52||||||Week 1-HSS0104-Tiredness At It's Worst||0.52|-0.35|
72470702|NCT04092452|144465187|SUPERIORITY||Risk Difference (RD)|0.06|STANDARD_ERROR_OF_MEAN|0.357|||TWO_SIDED|90.0|-0.54|0.65||||||Week 2-HSS0104-Tiredness At It's Worst||0.65|-0.54|
72470703|NCT04092452|144465187|SUPERIORITY||Risk Difference (RD)|-0.44|STANDARD_ERROR_OF_MEAN|0.344|||TWO_SIDED|90.0|-1.01|0.13||||||Week 2-HSS0104-Tiredness At It's Worst||0.13|-1.01|
72470704|NCT04092452|144465187|SUPERIORITY||Risk Difference (RD)|0.26|STANDARD_ERROR_OF_MEAN|0.356|||TWO_SIDED|90.0|-0.33|0.85||||||Week 2-HSS0104-Tiredness At It's Worst||0.85|-0.33|
72470705|NCT04092452|144465187|SUPERIORITY||Risk Difference (RD)|-0.12|STANDARD_ERROR_OF_MEAN|0.434|||TWO_SIDED|90.0|-0.83|0.6||||||Week 4-HSS0104-Tiredness At It's Worst||0.60|-0.83|
72470706|NCT04092452|144465187|SUPERIORITY||Risk Difference (RD)|-0.81|STANDARD_ERROR_OF_MEAN|0.414|||TWO_SIDED|90.0|-1.49|-0.12||||||Week 4-HSS0104-Tiredness At It's Worst||-0.12|-1.49|
72470707|NCT04092452|144465187|SUPERIORITY||Risk Difference (RD)|-0.14|STANDARD_ERROR_OF_MEAN|0.431|||TWO_SIDED|90.0|-0.86|0.57||||||Week 4-HSS0104-Tiredness At It's Worst||0.57|-0.86|
72565542|NCT03575871|144662366|SUPERIORITY||Difference in LS mean|-2.4|||<|0.0001|TWO_SIDED|95.0|-3.1|-1.7|||Mixed Models Analysis|||Week 8: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category), baseline value and an unstructured covariance matrix.||-1.7|-3.1|<0.0001
72395285|NCT03654651|144297231|SUPERIORITY||Mean Difference (Final Values)|2.2|||||TWO_SIDED|95.0|-3.8|8.2|||Mixed Models Analysis|||||8.2|-3.8|
72470708|NCT04092452|144465187|SUPERIORITY||Risk Difference (RD)|0.04|STANDARD_ERROR_OF_MEAN|0.483|||TWO_SIDED|90.0|-0.76|0.84||||||Week 6-HSS0104-Tiredness At It's Worst||0.84|-0.76|
72470709|NCT04092452|144465187|SUPERIORITY||Risk Difference (RD)|-0.52|STANDARD_ERROR_OF_MEAN|0.466|||TWO_SIDED|90.0|-1.29|0.26||||||Week 6-HSS0104-Tiredness At It's Worst||0.26|-1.29|
72470710|NCT04092452|144465187|SUPERIORITY||Risk Difference (RD)|0.12|STANDARD_ERROR_OF_MEAN|0.485|||TWO_SIDED|90.0|-0.68|0.92||||||Week 6-HSS0104-Tiredness At It's Worst||0.92|-0.68|
72470711|NCT04092452|144465187|SUPERIORITY||Risk Difference (RD)|-0.17|STANDARD_ERROR_OF_MEAN|0.483|||TWO_SIDED|90.0|-0.96|0.63||||||Week 8-HSS0104-Tiredness At It's Worst||0.63|-0.96|
72395286|NCT03654651|144297231|OTHER|change from baseline|Mean Difference (Final Values)|0.1|||||TWO_SIDED|95.0|-4.9|5.1|||Mixed Models Analysis|||||5.1|-4.9|
72395287|NCT03654651|144297231|OTHER|change from baseline|Mean Difference (Final Values)|-2.7|||||TWO_SIDED|95.0|-7.8|2.3|||Mixed Models Analysis|||||2.3|-7.8|
72395288|NCT03654651|144297232|SUPERIORITY||Mean Difference (Final Values)|-7.7|||||TWO_SIDED|95.0|-18.3|2.8|||Mixed Models Analysis|||||2.8|-18.3|
72395289|NCT03654651|144297232|OTHER|change from baseline|Mean Difference (Final Values)|-17.0|||||TWO_SIDED|95.0|-29.1|-4.8|||Mixed Models Analysis|||||-4.8|-29.1|
72505242|NCT01380093|144541497|SUPERIORITY_OR_OTHER||LS Mean Difference|-35.1||||0.0039|TWO_SIDED|95.0|-58.5|-11.7|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-11.7|-58.5|0.0039
72395290|NCT03654651|144297232|OTHER|change from baseline|Mean Difference (Final Values)|-5.7|||||TWO_SIDED|95.0|-17.1|5.7|||Mixed Models Analysis|||||5.7|-17.1|
72395291|NCT03654651|144297233|SUPERIORITY||Mean Difference (Final Values)|0.2|||||TWO_SIDED|95.0|-0.3|0.7|||Mixed Models Analysis|||||0.7|-0.3|
72470712|NCT04092452|144465187|SUPERIORITY||Risk Difference (RD)|-0.53|STANDARD_ERROR_OF_MEAN|0.466|||TWO_SIDED|90.0|-1.31|0.24||||||Week 8-HSS0104-Tiredness At It's Worst||0.24|-1.31|
72470713|NCT04092452|144465187|SUPERIORITY||Risk Difference (RD)|0.11|STANDARD_ERROR_OF_MEAN|0.488|||TWO_SIDED|90.0|-0.69|0.92||||||Week 8-HSS0104-Tiredness At It's Worst||0.92|-0.69|
72470714|NCT04092452|144465187|SUPERIORITY||Risk Difference (RD)|-0.34|STANDARD_ERROR_OF_MEAN|0.527|||TWO_SIDED|90.0|-1.21|0.53||||||Week 12-HSS0104-Tiredness At It's Worst||0.53|-1.21|
72470715|NCT04092452|144465187|SUPERIORITY||Risk Difference (RD)|-0.81|STANDARD_ERROR_OF_MEAN|0.503|||TWO_SIDED|90.0|-1.64|0.02||||||Week 12-HSS0104-Tiredness At It's Worst||0.02|-1.64|
72470716|NCT04092452|144465187|SUPERIORITY||Risk Difference (RD)|0.15|STANDARD_ERROR_OF_MEAN|0.527|||TWO_SIDED|90.0|-0.72|1.02||||||Week 12-HSS0104-Tiredness At It's Worst||1.02|-0.72|
72470717|NCT04092452|144465187|SUPERIORITY||Risk Difference (RD)|0.22|STANDARD_ERROR_OF_MEAN|0.559|||TWO_SIDED|90.0|-0.7|1.15||||||Week 16-HSS0104-Tiredness At It's Worst||1.15|-0.70|
72505243|NCT01380093|144541497|SUPERIORITY_OR_OTHER||LS Mean Difference|19.3||||0.1026|TWO_SIDED|95.0|-4.0|42.7|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||42.7|-4.0|0.1026
72505244|NCT01380093|144541497|SUPERIORITY_OR_OTHER||LS Mean Difference|54.4|||<|0.0001|TWO_SIDED|95.0|31.0|77.8|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||77.8|31.0|<0.0001
72505245|NCT01380093|144541498|SUPERIORITY_OR_OTHER||LS Mean Difference|-43.3||||0.0051|TWO_SIDED|95.0|-73.1|-13.5|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-13.5|-73.1|0.0051
72505246|NCT01380093|144541498|SUPERIORITY_OR_OTHER||LS Mean Difference|25.3||||0.0941|TWO_SIDED|95.0|-4.4|55.0|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||55.0|-4.4|0.0941
72505247|NCT01380093|144541498|SUPERIORITY_OR_OTHER||LS Mean Difference|68.6|||<|0.0001|TWO_SIDED|95.0|38.8|98.4|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||98.4|38.8|<0.0001
72395292|NCT03654651|144297233|OTHER|change from baseline|Mean Difference (Final Values)|0.2|||||TWO_SIDED|95.0|-0.1|1.5|||Mixed Models Analysis|||||1.5|-0.1|
72395293|NCT03654651|144297233|OTHER|change from baseline|Mean Difference (Final Values)|0.0|||||TWO_SIDED|95.0|-0.5|0.5|||Mixed Models Analysis|||||0.5|-0.5|
72395294|NCT01571427|144297235|EQUIVALENCE|It was calculated that 82 participants randomized in a 1:1 fashion between the 2 arms would have at least 80% to detect a Cohen's D of 0.45 in the difference in changes from baseline to week 6 at alpha=0.05 (two tailed). All randomized participants (n=83) were included in the analysis.|Mean Difference (Final Values)|-0.41|STANDARD_ERROR_OF_MEAN|0.35||0.25|TWO_SIDED||||||Regression, Linear||Estimates reported here is coefficient for the experimental group (with the control group as a reference), using a linear regression model controlling for Geriatric Depression Scale - 15 items version (GDS-15).|||||0.25
72470718|NCT04092452|144465187|SUPERIORITY||Risk Difference (RD)|-0.56|STANDARD_ERROR_OF_MEAN|0.532|||TWO_SIDED|90.0|-1.44|0.32||||||Week 16-HSS0104-Tiredness At It's Worst||0.32|-1.44|
72470719|NCT04092452|144465187|SUPERIORITY||Risk Difference (RD)|0.09|STANDARD_ERROR_OF_MEAN|0.557|||TWO_SIDED|90.0|-0.83|1.01||||||Week 16-HSS0104-Tiredness At It's Worst||1.01|-0.83|
72470720|NCT04092452|144465187|SUPERIORITY||Risk Difference (RD)|0.05|STANDARD_ERROR_OF_MEAN|0.264|||TWO_SIDED|90.0|-0.39|0.49||||||Week 1-HSS0105-Bothered By Appearance HS Lesion||0.49|-0.39|
72470721|NCT04092452|144465187|SUPERIORITY||Risk Difference (RD)|-0.32|STANDARD_ERROR_OF_MEAN|0.257|||TWO_SIDED|90.0|-0.75|0.1||||||Week 1-HSS0105-Bothered By Appearance HS Lesion||0.10|-0.75|
72470722|NCT04092452|144465187|SUPERIORITY||Risk Difference (RD)|-0.02|STANDARD_ERROR_OF_MEAN|0.266|||TWO_SIDED|90.0|-0.46|0.42||||||Week 1-HSS0105-Bothered By Appearance HS Lesion||0.42|-0.46|
72470723|NCT04092452|144465187|SUPERIORITY||Risk Difference (RD)|-0.1|STANDARD_ERROR_OF_MEAN|0.333|||TWO_SIDED|90.0|-0.65|0.45||||||Week 2-HSS0105-Bothered By Appearance HS Lesion||0.45|-0.65|
72470724|NCT04092452|144465187|SUPERIORITY||Risk Difference (RD)|-0.8|STANDARD_ERROR_OF_MEAN|0.321|||TWO_SIDED|90.0|-1.33|-0.27||||||Week 2-HSS0105-Bothered By Appearance HS Lesion||-0.27|-1.33|
72470725|NCT04092452|144465187|SUPERIORITY||Risk Difference (RD)|-0.36|STANDARD_ERROR_OF_MEAN|0.333|||TWO_SIDED|90.0|-0.91|0.19||||||Week 2-HSS0105-Bothered By Appearance HS Lesion||0.19|-0.91|
72470726|NCT04092452|144465187|SUPERIORITY||Risk Difference (RD)|0.32|STANDARD_ERROR_OF_MEAN|0.411|||TWO_SIDED|90.0|-0.36|1.0||||||Week 4-HSS0105-Bothered By Appearance HS Lesion||1.00|-0.36|
72470727|NCT04092452|144465187|SUPERIORITY||Risk Difference (RD)|-0.94|STANDARD_ERROR_OF_MEAN|0.393|||TWO_SIDED|90.0|-1.59|-0.29||||||Week 4-HSS0105-Bothered By Appearance HS Lesion||-0.29|-1.59|
72470728|NCT04092452|144465187|SUPERIORITY||Risk Difference (RD)|-0.29|STANDARD_ERROR_OF_MEAN|0.411|||TWO_SIDED|90.0|-0.97|0.39||||||Week 4-HSS0105-Bothered By Appearance HS Lesion||0.39|-0.97|
72470729|NCT04092452|144465187|SUPERIORITY||Risk Difference (RD)|0.55|STANDARD_ERROR_OF_MEAN|0.454|||TWO_SIDED|90.0|-0.2|1.3||||||Week 6-HSS0105-Bothered By Appearance HS Lesion||1.30|-0.20|
72622613|NCT00561821|144775365|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA|||||||<0.0001
72622614|NCT00561821|144775366|SUPERIORITY_OR_OTHER|||||||0.001||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA|||||||0.001
72622615|NCT00561821|144775366|SUPERIORITY_OR_OTHER|||||||0.0213||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA|||||||0.0213
72622616|NCT00561821|144775366|SUPERIORITY_OR_OTHER|||||||0.0135||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA|||||||0.0135
72622617|NCT00561821|144775367|SUPERIORITY_OR_OTHER|||||||0.0001||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA|||||||0.0001
72622618|NCT00561821|144775367|SUPERIORITY_OR_OTHER|||||||0.0003||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA|||||||0.0003
72622619|NCT00561821|144775367|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA|||||||<0.0001
72622620|NCT00561821|144775368|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA|||||||<0.0001
72622621|NCT00561821|144775368|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA|||||||<0.0001
72395295|NCT01571427|144297235|EQUIVALENCE|Power calculation was based on the entire sample (CDR=0 and CDR=0.5 combined). Analyses within each CDR group are exploratory.|Median Difference (Final Values)|-0.49|STANDARD_ERROR_OF_MEAN|0.42||0.25|TWO_SIDED||||||Regression, Linear||Estimates reported here is coefficient for the experimental group (with the control group as a reference), using a linear regression model controlling for Geriatric Depression Scale - 15 items version (GDS-15).|Analysis 2: AMONG CDR=0 group (N=49)||||0.25
72470730|NCT04092452|144465187|SUPERIORITY||Risk Difference (RD)|-0.69|STANDARD_ERROR_OF_MEAN|0.439|||TWO_SIDED|90.0|-1.41|0.04||||||Week 6-HSS0105-Bothered By Appearance HS Lesion||0.04|-1.41|
72470731|NCT04092452|144465187|SUPERIORITY||Risk Difference (RD)|-0.1|STANDARD_ERROR_OF_MEAN|0.456|||TWO_SIDED|90.0|-0.85|0.66||||||Week 6-HSS0105-Bothered By Appearance HS Lesion||0.66|-0.85|
72470732|NCT04092452|144465187|SUPERIORITY||Risk Difference (RD)|-0.15|STANDARD_ERROR_OF_MEAN|0.491|||TWO_SIDED|90.0|-0.96|0.66||||||Week 8-HSS0105-Bothered By Appearance HS Lesion||0.66|-0.96|
72470733|NCT04092452|144465187|SUPERIORITY||Risk Difference (RD)|-1.11|STANDARD_ERROR_OF_MEAN|0.473|||TWO_SIDED|90.0|-1.89|-0.33||||||Week 8-HSS0105-Bothered By Appearance HS Lesion||-0.33|-1.89|
72470734|NCT04092452|144465187|SUPERIORITY||Risk Difference (RD)|-0.3|STANDARD_ERROR_OF_MEAN|0.497|||TWO_SIDED|90.0|-1.13|0.52||||||Week 8-HSS0105-Bothered By Appearance HS Lesion||0.52|-1.13|
72470735|NCT04092452|144465187|SUPERIORITY||Risk Difference (RD)|0.05|STANDARD_ERROR_OF_MEAN|0.547|||TWO_SIDED|90.0|-0.86|0.95||||||Week 12-HSS0105-Bothered By Appearance HS Lesion||0.95|-0.86|
72622622|NCT00561821|144775368|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA|||||||<0.0001
72622623|NCT00561821|144775369|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA|||||||<0.0001
72622624|NCT00561821|144775369|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA|||||||<0.0001
72622625|NCT00561821|144775369|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA|||||||<0.0001
72622626|NCT00561821|144775370|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA|||||||<0.0001
72622627|NCT00561821|144775370|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA|||||||<0.0001
72622628|NCT00561821|144775370|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA|||||||<0.0001
72622629|NCT00561821|144775371|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA|||||||<0.0001
72622630|NCT00561821|144775371|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA|||||||<0.0001
72622631|NCT00561821|144775371|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA|||||||<0.0001
72622632|NCT00561821|144775372|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA|||||||<0.0001
72622633|NCT00561821|144775372|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA|||||||<0.0001
72622634|NCT00561821|144775372|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA|||||||<0.0001
72622635|NCT00561821|144775373|SUPERIORITY_OR_OTHER|||||||0.6317||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA|||||||0.6317
72622636|NCT00561821|144775373|SUPERIORITY_OR_OTHER|||||||0.6355||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA|||||||0.6355
72622637|NCT00561821|144775373|SUPERIORITY_OR_OTHER|||||||0.7865||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA|||||||0.7865
72622638|NCT00561821|144775374|SUPERIORITY_OR_OTHER|||||||0.4033||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA|||||||0.4033
72622639|NCT00561821|144775374|SUPERIORITY_OR_OTHER|||||||0.4153||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA|||||||0.4153
72395296|NCT01571427|144297235|EQUIVALENCE|Power calculation was based on the entire sample which combined CDR=0 and CDR=0.5 groups. Analyses within each CDR group are exploratory.|Median Difference (Final Values)|-0.11|STANDARD_ERROR_OF_MEAN|0.62||0.85|TWO_SIDED||||||Regression, Linear||Estimates reported here is coefficient for the experimental group (with the control group as a reference), using a linear regression model controlling for Geriatric Depression Scale - 15 items version (GDS-15).|Analyses 3: AMONG CDR=0.5 (Mild Cognitive Impairment) group, N=34 .||||0.85
72622640|NCT00561821|144775374|SUPERIORITY_OR_OTHER|||||||0.6271||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA|||||||0.6271
72470736|NCT04092452|144465187|SUPERIORITY||Risk Difference (RD)|-0.87|STANDARD_ERROR_OF_MEAN|0.523|||TWO_SIDED|90.0|-1.73|-0.01||||||Week 12-HSS0105-Bothered By Appearance HS Lesion||-0.01|-1.73|
72470737|NCT04092452|144465187|SUPERIORITY||Risk Difference (RD)|0.12|STANDARD_ERROR_OF_MEAN|0.547|||TWO_SIDED|90.0|-0.78|1.03||||||Week 12-HSS0105-Bothered By Appearance HS Lesion||1.03|-0.78|
72470738|NCT04092452|144465187|SUPERIORITY||Risk Difference (RD)|0.39|STANDARD_ERROR_OF_MEAN|0.602|||TWO_SIDED|90.0|-0.6|1.39||||||Week 16-HSS0105-Bothered By Appearance HS Lesion||1.39|-0.60|
72470739|NCT04092452|144465187|SUPERIORITY||Risk Difference (RD)|-0.95|STANDARD_ERROR_OF_MEAN|0.574|||TWO_SIDED|90.0|-1.9|0.0||||||Week 16-HSS0105-Bothered By Appearance HS Lesion||0.00|-1.90|
72470740|NCT04092452|144465187|SUPERIORITY||Risk Difference (RD)|-0.01|STANDARD_ERROR_OF_MEAN|0.6|||TWO_SIDED|90.0|-1.0|0.99||||||Week 16-HSS0105-Bothered By Appearance HS Lesion||0.99|-1.00|
72470741|NCT04092452|144465188|SUPERIORITY||Risk Difference (RD)|-0.2|STANDARD_ERROR_OF_MEAN|0.295|||TWO_SIDED|90.0|-0.69|0.29||||||Week 1-HSS0101-Pain At It's Worst||0.29|-0.69|
72470742|NCT04092452|144465188|SUPERIORITY||Risk Difference (RD)|-0.48|STANDARD_ERROR_OF_MEAN|0.287|||TWO_SIDED|90.0|-0.96|-0.01||||||Week 1-HSS0101-Pain At It's Worst||-0.01|-0.96|
72470743|NCT04092452|144465188|SUPERIORITY||Risk Difference (RD)|-0.42|STANDARD_ERROR_OF_MEAN|0.295|||TWO_SIDED|90.0|-0.91|0.06||||||Week 1-HSS0101-Pain At It's Worst||0.06|-0.91|
72470744|NCT04092452|144465188|SUPERIORITY||Risk Difference (RD)|-0.3|STANDARD_ERROR_OF_MEAN|0.392|||TWO_SIDED|90.0|-0.95|0.35||||||Week 2-HSS0101-Pain At It's Worst||0.35|-0.95|
72470745|NCT04092452|144465188|SUPERIORITY||Risk Difference (RD)|-0.71|STANDARD_ERROR_OF_MEAN|0.377|||TWO_SIDED|90.0|-1.33|-0.08||||||Week 2-HSS0101-Pain At It's Worst||-0.08|-1.33|
72470746|NCT04092452|144465188|SUPERIORITY||Risk Difference (RD)|-0.57|STANDARD_ERROR_OF_MEAN|0.391|||TWO_SIDED|90.0|-1.21|0.08||||||Week 2-HSS0101-Pain At It's Worst||0.08|-1.21|
72470747|NCT04092452|144465188|SUPERIORITY||Risk Difference (RD)|0.26|STANDARD_ERROR_OF_MEAN|0.481|||TWO_SIDED|90.0|-0.54|1.05||||||Week 4-HSS0101-Pain At It's Worst||1.05|-0.54|
72505248|NCT01380093|144541499|SUPERIORITY_OR_OTHER||LS Mean Difference|-49.0||||0.0083|TWO_SIDED|95.0|-85.0|-13.1|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-13.1|-85.0|0.0083
72505249|NCT01380093|144541499|SUPERIORITY_OR_OTHER||LS Mean Difference|32.3||||0.0766|TWO_SIDED|95.0|-3.5|68.1|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||68.1|-3.5|0.0766
72505250|NCT01380093|144541499|SUPERIORITY_OR_OTHER||LS Mean Difference|81.3|||<|0.0001|TWO_SIDED|95.0|45.4|117.3|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||117.3|45.4|<0.0001
72505251|NCT01380093|144541500|SUPERIORITY_OR_OTHER||LS Mean Difference|-8.0||||0.0018|TWO_SIDED|95.0|-12.9|-3.1|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-3.1|-12.9|0.0018
72505252|NCT01380093|144541500|SUPERIORITY_OR_OTHER||LS Mean Difference|4.8||||0.0527|TWO_SIDED|95.0|-0.1|9.7|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||9.7|-0.1|0.0527
72505253|NCT01380093|144541500|SUPERIORITY_OR_OTHER||LS Mean Difference|12.8|||<|0.0001|TWO_SIDED|95.0|7.9|17.7|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||17.7|7.9|<0.0001
72505254|NCT01380093|144541501|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4||||0.3986|TWO_SIDED|95.0|-1.4|0.6|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||0.6|-1.4|0.3986
72505255|NCT01380093|144541501|SUPERIORITY_OR_OTHER||LS Mean Difference|1.5||||0.0023|TWO_SIDED|95.0|0.6|2.5|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||2.5|0.6|0.0023
72505256|NCT01380093|144541501|SUPERIORITY_OR_OTHER||LS Mean Difference|1.9||||0.0002|TWO_SIDED|95.0|1.0|2.9|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||2.9|1.0|0.0002
72505257|NCT01380093|144541502|SUPERIORITY_OR_OTHER||LS Mean Difference|-11.2||||0.0029|TWO_SIDED|95.0|-18.0|-4.0|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-4|-18|0.0029
72622641|NCT00561821|144775375|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA|||||||<0.0001
72622642|NCT00561821|144775375|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA|||||||<0.0001
72622643|NCT00561821|144775375|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA|||||||<0.0001
72395297|NCT01571427|144297236|EQUIVALENCE|It was calculated that 82 participants randomized in a 1:1 fashion between the 2 arms would have at least 80% to detect a Cohen's D of 0.45 in the difference in changes from baseline to week 6 at alpha=0.05 (two tailed). All randomized participants (n=83) were included in the analysis.|Mean Difference (Final Values)|2.2|STANDARD_ERROR_OF_MEAN|0.92||0.02|TWO_SIDED||||||Regression, Linear||Estimates reported here is coefficient for the experimental group (with the control group as a reference), using a linear regression model controlling for Geriatric Depression Scale - 15 items version (GDS-15).|||||0.02
72565543|NCT03575871|144662366|SUPERIORITY||Difference in LS mean|-0.9||||0.0164|TWO_SIDED|95.0|-1.7|-0.2|||Mixed Models Analysis|||Week 12: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category), baseline value and an unstructured covariance matrix.||-0.2|-1.7|0.0164
72565544|NCT03575871|144662366|SUPERIORITY||Difference in LS mean|-1.7|||<|0.0001|TWO_SIDED|95.0|-2.5|-1.0|||Mixed Models Analysis|||Week 12: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category), baseline value and an unstructured covariance matrix.||-1.0|-2.5|<0.0001
72565545|NCT03575871|144662367|SUPERIORITY||Difference in LS mean|-20.9|||<|0.0001|TWO_SIDED|95.0|-26.6|-15.1|||Mixed Models Analysis|||Change at Week 2: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-15.1|-26.6|<0.0001
72565546|NCT03575871|144662367|SUPERIORITY||Difference in LS mean|-32.1|||<|0.0001|TWO_SIDED|95.0|-37.9|-26.4|||Mixed Models Analysis|||Change at Week 2: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-26.4|-37.9|<0.0001
72565547|NCT03575871|144662367|SUPERIORITY||Difference in LS mean|-21.6|||<|0.0001|TWO_SIDED|95.0|-28.1|-15.2|||Mixed Models Analysis|||Change at Week 4: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-15.2|-28.1|<0.0001
72565548|NCT03575871|144662367|SUPERIORITY||Difference in LS mean|-35.9|||<|0.0001|TWO_SIDED|95.0|-42.3|-29.4|||Mixed Models Analysis|||Change at Week 4: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-29.4|-42.3|<0.0001
72395298|NCT01571427|144297236|EQUIVALENCE|Power calculation was based on the entire sample which combined CDR=0 and CDR=0.5 groups. Analyses by each CDR group are exploratory.|Mean Difference (Final Values)|4.0|STANDARD_ERROR_OF_MEAN|1.28||0.003|TWO_SIDED|||||Statistically significant based on the Bonferroni multiple comparison adjusted P value of P\<0.004.|Regression, Linear||Estimates reported here is coefficient for the experimental group (with the control group as a reference), using a linear regression model controlling for Geriatric Depression Scale - 15 items version (GDS-15).|Analysis 2: AMONG CDR=0 group (N=49)||||0.003
72565549|NCT03575871|144662367|SUPERIORITY||Difference in LS mean|-19.4|||<|0.0001|TWO_SIDED|95.0|-26.8|-12.1|||Mixed Models Analysis|||Change at Week 8: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-12.1|-26.8|<0.0001
72565550|NCT03575871|144662367|SUPERIORITY||Difference in LS mean|-33.6|||<|0.0001|TWO_SIDED|95.0|-41.0|-26.3|||Mixed Models Analysis|||Change at Week 8: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-26.3|-41.0|<0.0001
72565551|NCT03575871|144662367|SUPERIORITY||Difference in LS mean|-23.1|||<|0.0001|TWO_SIDED|95.0|-32.3|-13.9|||Mixed Models Analysis|||Change at Week 12: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-13.9|-32.3|<0.0001
72565552|NCT03575871|144662367|SUPERIORITY||Difference in LS mean|-33.4|||<|0.0001|TWO_SIDED|95.0|-42.6|-24.3|||Mixed Models Analysis|||Change at Week 12: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-24.3|-42.6|<0.0001
72565553|NCT01744093|144662376|OTHER|Descriptive proportion|Proportion (percent)|18.8|||||TWO_SIDED|95.0|4.0|45.6|||||Exact two-sided 95% Clopper-Pearson confidence interval.|||45.6|4.0|
72565554|NCT01744093|144662377|SUPERIORITY||Proportion (percent)|6.3||||0.002|TWO_SIDED|95.0|0.16|30.2|||Fisher Exact||Exact two-sided 95% Clopper-Pearson confidence interval.|Null hypothesis adverse event rate (grade 2 or higher toxicity) = 45.5%||30.2|0.16|0.002
72565555|NCT01173471|144662388|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.3|STANDARD_ERROR_OF_MEAN|5.352||0.822|TWO_SIDED|95.0|-15.2|12.6|||Mixed Models Analysis||Difference is (AZD4017 200 mg OD - Placebo OD)|||12.6|-15.2|0.822
72565556|NCT01173471|144662388|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.9|STANDARD_ERROR_OF_MEAN|3.516||0.413|TWO_SIDED|95.0|-10.1|4.3|||Mixed Models Analysis||Difference is (AZD4017 400 mg BID - Placebo BID)|||4.3|-10.1|0.413
72565557|NCT01173471|144662390|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|1.57||0.758|TWO_SIDED|95.0|-4.8|3.7|||Mixed Models Analysis||Difference is (AZD4017 200 mg OD - Placebo OD)|||3.7|-4.8|0.758
72565558|NCT01173471|144662390|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|0.909||0.467|TWO_SIDED|95.0|-2.5|1.2|||Mixed Models Analysis||Difference is (AZD4017 400 mg BID - Placebo BID)|||1.2|-2.5|0.467
72565559|NCT03028740|144662391|SUPERIORITY||Percentage Difference|-3.2||||0.2067|TWO_SIDED|95.0|-8.2|1.9||P-value was based on Cochran-Mantel-Haenszel general association test comparing Cenicriviroc vs Placebo, controlling for factors (randomization strata: fibrosis stage \[2 vs 3\] and presence or absence of Type 2 diabetes mellitus (T2DM) at Baseline).|Cochran-Mantel-Haenszel|||||1.9|-8.2|0.2067
72565560|NCT03028740|144662391|SUPERIORITY||Odds Ratio (OR)|0.8369|||||TWO_SIDED|95.0|0.6341|1.1044|||||Odds Ratio was based on Mantel-Haenszel estimates comparing Cenicriviroc vs Placebo, controlling for factors (randomization strata: fibrosis stage \[2 vs 3\] and presence or absence of T2DM at Baseline).|||1.1044|0.6341|
72622644|NCT00561821|144775376|SUPERIORITY_OR_OTHER|||||||0.0243||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA|||||||0.0243
72505258|NCT01380093|144541502|SUPERIORITY_OR_OTHER||LS Mean Difference|8.1||||0.0286|TWO_SIDED|95.0|1.0|15.0|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||15|1|0.0286
72505259|NCT01380093|144541502|SUPERIORITY_OR_OTHER||LS Mean Difference|19.3|||<|0.0001|TWO_SIDED|95.0|12.0|27.0|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||27|12|<0.0001
72505260|NCT01380093|144541503|SUPERIORITY_OR_OTHER||LS Mean Difference|-13.0||||0.005|TWO_SIDED|95.0|-22.0|-4.0|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-4|-22|0.0050
72505261|NCT01380093|144541503|SUPERIORITY_OR_OTHER||LS Mean Difference|8.2||||0.07|TWO_SIDED|95.0|-1.0|17.0|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||17|-1|0.0700
72505262|NCT01380093|144541503|SUPERIORITY_OR_OTHER||LS Mean Difference|21.2|||<|0.0001|TWO_SIDED|95.0|12.0|30.0|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||30|12|<0.0001
72505263|NCT01380093|144541504|SUPERIORITY_OR_OTHER||LS Mean Difference|0.7|||<|0.0001|TWO_SIDED|95.0|0.5|0.9|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||0.9|0.5|<0.0001
72505264|NCT01380093|144541504|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.5|||<|0.0001|TWO_SIDED|95.0|-0.8|-0.3|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-0.3|-0.8|<0.0001
72505265|NCT01380093|144541504|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.2|||<|0.0001|TWO_SIDED|95.0|-1.5|-1.0|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-1.0|-1.5|<0.0001
72505266|NCT01380093|144541505|SUPERIORITY_OR_OTHER||LS Mean Difference|2.4|||<|0.0001|TWO_SIDED|95.0|1.9|2.9|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||2.9|1.9|<0.0001
72505267|NCT01380093|144541505|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.7|||<|0.0001|TWO_SIDED|95.0|-2.2|-1.3|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-1.3|-2.2|<0.0001
72505268|NCT01380093|144541505|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.1|||<|0.0001|TWO_SIDED|95.0|-4.6|-3.6|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-3.6|-4.6|<0.0001
72505269|NCT01380093|144541506|SUPERIORITY_OR_OTHER||LS Mean Difference|4.9|||<|0.0001|TWO_SIDED|95.0|3.9|5.8|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||5.8|3.9|<0.0001
72565561|NCT03028740|144662393|SUPERIORITY||Percentage Difference|-1.7||||0.2827|TWO_SIDED|95.0|-4.8|1.5||P-value was based on Cochran-Mantel-Haenszel general association test comparing Cenicriviroc vs Placebo, controlling for factors (randomization strata: fibrosis stage \[2 vs 3\] and presence or absence of T2DM at Baseline).|Cochran-Mantel-Haenszel|||||1.5|-4.8|0.2827
72622645|NCT00561821|144775376|SUPERIORITY_OR_OTHER|||||||0.0242||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA|||||||0.0242
72505270|NCT01380093|144541506|SUPERIORITY_OR_OTHER||LS Mean Difference|-5.3|||<|0.0001|TWO_SIDED|95.0|-6.3|-4.3|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-4.3|-6.3|<0.0001
72505271|NCT01380093|144541506|SUPERIORITY_OR_OTHER||LS Mean Difference|-10.1|||<|0.0001|TWO_SIDED|95.0|-11.1|-9.2|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-9.2|-11.1|<0.0001
72505272|NCT01380093|144541507|SUPERIORITY_OR_OTHER||LS Mean Difference|8.6|||<|0.0001|TWO_SIDED|95.0|6.6|10.7|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||10.7|6.6|<0.0001
72505273|NCT01380093|144541507|SUPERIORITY_OR_OTHER||LS Mean Difference|-13.8|||<|0.0001|TWO_SIDED|95.0|-15.9|-11.8|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-11.8|-15.9|<0.0001
72505274|NCT01380093|144541507|SUPERIORITY_OR_OTHER||LS Mean Difference|-22.4|||<|0.0001|TWO_SIDED|95.0|-24.5|-20.4|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-20.4|-24.5|<0.0001
72565562|NCT03028740|144662393|SUPERIORITY||Odds Ratio (OR)|0.7844|||||TWO_SIDED|95.0|0.5032|1.2229|||||Odds Ratio was based on Mantel-Haenszel estimates comparing Cenicriviroc vs Placebo, controlling for factors (randomization strata: fibrosis stage \[2 vs 3\] and presence or absence of T2DM at Baseline).|||1.2229|0.5032|
72565563|NCT03028740|144662394|SUPERIORITY||Percentage Difference|-2.7||||0.4054|TWO_SIDED|95.0|-8.7|3.3||P-value was based on Cochran-Mantel-Haenszel general association test comparing Cenicriviroc vs Placebo, controlling for factors (randomization strata: fibrosis stage \[2 vs 3\] and presence or absence of T2DM at Baseline).|Cochran-Mantel-Haenszel|||||3.3|-8.7|0.4054
72622646|NCT00561821|144775376|SUPERIORITY_OR_OTHER|||||||0.0007||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA|||||||0.0007
72505275|NCT01380093|144541508|SUPERIORITY_OR_OTHER||LS Mean Difference|11.7|||<|0.0001|TWO_SIDED|95.0|8.7|14.7|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||14.7|8.7|<0.0001
72505276|NCT01380093|144541508|SUPERIORITY_OR_OTHER||LS Mean Difference|-21.5|||<|0.0001|TWO_SIDED|95.0|-24.5|-18.6|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-18.6|-24.5|<0.0001
72505277|NCT01380093|144541508|SUPERIORITY_OR_OTHER||LS Mean Difference|-33.2|||<|0.0001|TWO_SIDED|95.0|-36.2|-30.2|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-30.2|-36.2|<0.0001
72505278|NCT01380093|144541509|SUPERIORITY_OR_OTHER||LS Mean Difference|17.5|||<|0.0001|TWO_SIDED|95.0|11.6|23.3|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||23.3|11.6|<0.0001
72505279|NCT01380093|144541509|SUPERIORITY_OR_OTHER||LS Mean Difference|-37.7|||<|0.0001|TWO_SIDED|95.0|-43.6|-31.9|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-31.9|-43.6|<0.0001
72505280|NCT01380093|144541509|SUPERIORITY_OR_OTHER||LS Mean Difference|-55.2|||<|0.0001|TWO_SIDED|95.0|-61.1|-49.3|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-49.3|-61.1|<0.0001
72505281|NCT01380093|144541510|SUPERIORITY_OR_OTHER||LS Mean Difference|1.1|||<|0.0001|TWO_SIDED|95.0|0.8|1.4|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||1.4|0.8|<0.0001
72505282|NCT01380093|144541510|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.8|||<|0.0001|TWO_SIDED|95.0|-2.1|-1.5|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-1.5|-2.1|<0.0001
72505283|NCT01380093|144541510|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.9|||<|0.0001|TWO_SIDED|95.0|-3.2|-2.6|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-2.6|-3.2|<0.0001
72505284|NCT01380093|144541511|SUPERIORITY_OR_OTHER||LS Mean Difference|2.5||||0.0262|TWO_SIDED|95.0|0.3|4.6|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||4.6|0.3|0.0262
72505285|NCT01380093|144541511|SUPERIORITY_OR_OTHER||LS Mean Difference|0.9||||0.418|TWO_SIDED|95.0|-1.3|3.0|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||3.0|-1.3|0.4180
72505286|NCT01380093|144541511|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.6||||0.1479|TWO_SIDED|95.0|-3.7|0.6|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||0.6|-3.7|0.1479
72505287|NCT01380093|144541512|SUPERIORITY_OR_OTHER||LS Mean Difference|0.21||||0.0181|TWO_SIDED|90.0|0.07|0.35|||Mixed Models Analysis|||Tmax was analyzed using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||0.35|0.07|0.0181
72505288|NCT01380093|144541513|SUPERIORITY_OR_OTHER||Geometric mean ratio|0.75|||<|0.0001|TWO_SIDED|90.0|0.68|0.83|||Mixed Models Analysis|||Natural log transformed Cmax was analyzed using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||0.83|0.68|<0.0001
72505289|NCT01380093|144541514|SUPERIORITY_OR_OTHER||Geometric mean ratio|0.77||||0.0004|TWO_SIDED|90.0|0.69|0.86|||Mixed Models Analysis|||Natural log transformed AUC (0-1) was analyzed using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||0.86|0.69|0.0004
72505290|NCT01380093|144541515|SUPERIORITY_OR_OTHER||Geometric mean ratio|0.86||||0.0065|TWO_SIDED|90.0|0.79|0.94|||Mixed Models Analysis|||Natural log transformed AUC (0-2) was analyzed using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||0.94|0.79|0.0065
72505291|NCT01380093|144541516|SUPERIORITY_OR_OTHER||Geometric mean ratio|0.98||||0.6399|TWO_SIDED|90.0|0.91|1.06|||Mixed Models Analysis|||Natural log transformed AUC (0-4) was analyzed using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||1.06|0.91|0.6399
72505292|NCT01380093|144541517|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.0||||0.9057|TWO_SIDED|90.0|0.94|1.08|||Mixed Models Analysis|||Natural log transformed AUC (0-8) was analyzed using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||1.08|0.94|0.9057
72505293|NCT01380093|144541518|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.03||||0.425|TWO_SIDED|90.0|0.97|1.1|||Mixed Models Analysis|||Natural log transformed AUC (0-12) was analyzed using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||1.10|0.97|0.4250
72505294|NCT01380093|144541519|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.1||||0.0204|TWO_SIDED|90.0|1.03|1.18|||Mixed Models Analysis|||Natural log transformed AUC (0-24) was analyzed using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||1.18|1.03|0.0204
72505295|NCT01380093|144541520|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.32||||0.0005|TWO_SIDED|90.0|1.17|1.49|||Mixed Models Analysis|||Natural log transformed AUC (0-∞) was analyzed using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||1.49|1.17|0.0005
72505296|NCT03237845|144541592|SUPERIORITY||Risk Difference (RD)|7.6||||0.0006|TWO_SIDED|95.0|3.3|11.9|||Cochran-Mantel-Haenszel|||||11.9|3.3|0.0006
72470748|NCT04092452|144465188|SUPERIORITY||Risk Difference (RD)|-0.39|STANDARD_ERROR_OF_MEAN|0.458|||TWO_SIDED|90.0|-1.15|0.37||||||Week 4-HSS0101-Pain At It's Worst||0.37|-1.15|
72505297|NCT03237845|144541593|SUPERIORITY||Risk Difference (RD)|12.4|||<|0.0001|TWO_SIDED|95.0|6.9|17.9|||Cochran-Mantel-Haenszel|||||17.9|6.9|< 0.0001
72505298|NCT03237845|144541594|SUPERIORITY||Risk Difference (RD)|15.1|||<|0.0001|TWO_SIDED|95.0|9.4|20.8|||Cochran-Mantel-Haenszel|||||20.8|9.4|< 0.0001
72622647|NCT00561821|144775377|SUPERIORITY_OR_OTHER|||||||0.0199||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA|||||||0.0199
72470749|NCT04092452|144465188|SUPERIORITY||Risk Difference (RD)|-0.06|STANDARD_ERROR_OF_MEAN|0.478|||TWO_SIDED|90.0|-0.85|0.73||||||Week 4-HSS0101-Pain At It's Worst||0.73|-0.85|
72470750|NCT04092452|144465188|SUPERIORITY||Risk Difference (RD)|0.62|STANDARD_ERROR_OF_MEAN|0.524|||TWO_SIDED|90.0|-0.24|1.49||||||Week 6-HSS0101-Pain At It's Worst||1.49|-0.24|
72470751|NCT04092452|144465188|SUPERIORITY||Risk Difference (RD)|-0.19|STANDARD_ERROR_OF_MEAN|0.505|||TWO_SIDED|90.0|-1.03|0.64||||||Week 6-HSS0101-Pain At It's Worst||0.64|-1.03|
72470752|NCT04092452|144465188|SUPERIORITY||Risk Difference (RD)|0.21|STANDARD_ERROR_OF_MEAN|0.526|||TWO_SIDED|90.0|-0.66|1.08||||||Week 6-HSS0101-Pain At It's Worst||1.08|-0.66|
72470753|NCT04092452|144465188|SUPERIORITY||Risk Difference (RD)|0.24|STANDARD_ERROR_OF_MEAN|0.558|||TWO_SIDED|90.0|-0.69|1.16||||||Week 8-HSS0101-Pain At It's Worst||1.16|-0.69|
72470754|NCT04092452|144465188|SUPERIORITY||Risk Difference (RD)|-0.32|STANDARD_ERROR_OF_MEAN|0.539|||TWO_SIDED|90.0|-1.21|0.57||||||Week 8-HSS0101-Pain At It's Worst||0.57|-1.21|
72470755|NCT04092452|144465188|SUPERIORITY||Risk Difference (RD)|0.44|STANDARD_ERROR_OF_MEAN|0.565|||TWO_SIDED|90.0|-0.49|1.38||||||Week 8-HSS0101-Pain At It's Worst||1.38|-0.49|
72470756|NCT04092452|144465188|SUPERIORITY||Risk Difference (RD)|0.16|STANDARD_ERROR_OF_MEAN|0.578|||TWO_SIDED|90.0|-0.79|1.12||||||Week 12-HSS0101-Pain At It's Worst||1.12|-0.79|
72470757|NCT04092452|144465188|SUPERIORITY||Risk Difference (RD)|-0.68|STANDARD_ERROR_OF_MEAN|0.55|||TWO_SIDED|90.0|-1.59|0.23||||||Week 12-HSS0101-Pain At It's Worst||0.23|-1.59|
72470758|NCT04092452|144465188|SUPERIORITY||Risk Difference (RD)|0.08|STANDARD_ERROR_OF_MEAN|0.576|||TWO_SIDED|90.0|-0.88|1.03||||||Week 12-HSS0101-Pain At It's Worst||1.03|-0.88|
72505299|NCT03237845|144541595|SUPERIORITY||Risk Difference (RD)|9.9||||0.0039|TWO_SIDED|95.0|3.2|16.6|||Cochran-Mantel-Haenszel|||||16.6|3.2|0.0039
72470759|NCT04092452|144465188|SUPERIORITY||Risk Difference (RD)|0.08|STANDARD_ERROR_OF_MEAN|0.631|||TWO_SIDED|90.0|-0.96|1.13||||||Week 16-HSS0101-Pain At It's Worst||1.13|-0.96|
72470760|NCT04092452|144465188|SUPERIORITY||Risk Difference (RD)|-1.25|STANDARD_ERROR_OF_MEAN|0.6|||TWO_SIDED|90.0|-2.24|-0.25||||||Week 16-HSS0101-Pain At It's Worst||-0.25|-2.24|
72470761|NCT04092452|144465188|SUPERIORITY||Risk Difference (RD)|-0.91|STANDARD_ERROR_OF_MEAN|0.628|||TWO_SIDED|90.0|-1.95|0.13||||||Week 16-HSS0101-Pain At It's Worst||0.13|-1.95|
72470762|NCT04092452|144465188|SUPERIORITY||Risk Difference (RD)|0.01|STANDARD_ERROR_OF_MEAN|0.286|||TWO_SIDED|90.0|-0.47|0.48||||||Week 1-HSS0102-Tenderness At It's Worst||0.48|-0.47|
72470763|NCT04092452|144465188|SUPERIORITY||Risk Difference (RD)|-0.28|STANDARD_ERROR_OF_MEAN|0.278|||TWO_SIDED|90.0|-0.75|0.18||||||Week 1-HSS0102-Tenderness At It's Worst||0.18|-0.75|
72470764|NCT04092452|144465188|SUPERIORITY||Risk Difference (RD)|-0.31|STANDARD_ERROR_OF_MEAN|0.286|||TWO_SIDED|90.0|-0.78|0.17||||||Week 1-HSS0102-Tenderness At It's Worst||0.17|-0.78|
72470765|NCT04092452|144465188|SUPERIORITY||Risk Difference (RD)|-0.22|STANDARD_ERROR_OF_MEAN|0.361|||TWO_SIDED|90.0|-0.81|0.38||||||Week 2-HSS0102-Tenderness At It's Worst||0.38|-0.81|
72470766|NCT04092452|144465188|SUPERIORITY||Risk Difference (RD)|-0.4|STANDARD_ERROR_OF_MEAN|0.347|||TWO_SIDED|90.0|-0.97|0.18||||||Week 2-HSS0102-Tenderness At It's Worst||0.18|-0.97|
72470767|NCT04092452|144465188|SUPERIORITY||Risk Difference (RD)|-0.46|STANDARD_ERROR_OF_MEAN|0.36|||TWO_SIDED|90.0|-1.05|0.14||||||Week 2-HSS0102-Tenderness At It's Worst||0.14|-1.05|
72470768|NCT04092452|144465188|SUPERIORITY||Risk Difference (RD)|0.22|STANDARD_ERROR_OF_MEAN|0.471|||TWO_SIDED|90.0|-0.56|1.0||||||Week 4-HSS0102-Tenderness At It's Worst||1.00|-0.56|
72470769|NCT04092452|144465188|SUPERIORITY||Risk Difference (RD)|-0.25|STANDARD_ERROR_OF_MEAN|0.448|||TWO_SIDED|90.0|-0.99|0.49||||||Week 4-HSS0102-Tenderness At It's Worst||0.49|-0.99|
72470770|NCT04092452|144465188|SUPERIORITY||Risk Difference (RD)|-0.11|STANDARD_ERROR_OF_MEAN|0.468|||TWO_SIDED|90.0|-0.88|0.67||||||Week 4-HSS0102-Tenderness At It's Worst||0.67|-0.88|
72470771|NCT04092452|144465188|SUPERIORITY||Risk Difference (RD)|0.48|STANDARD_ERROR_OF_MEAN|0.52|||TWO_SIDED|90.0|-0.38|1.34||||||Week 6-HSS0102-Tenderness At It's Worst||1.34|-0.38|
72470772|NCT04092452|144465188|SUPERIORITY||Risk Difference (RD)|-0.23|STANDARD_ERROR_OF_MEAN|0.501|||TWO_SIDED|90.0|-1.06|0.6||||||Week 6-HSS0102-Tenderness At It's Worst||0.60|-1.06|
72470773|NCT04092452|144465188|SUPERIORITY||Risk Difference (RD)|0.01|STANDARD_ERROR_OF_MEAN|0.523|||TWO_SIDED|90.0|-0.86|0.87||||||Week 6-HSS0102-Tenderness At It's Worst||0.87|-0.86|
72470774|NCT04092452|144465188|SUPERIORITY||Risk Difference (RD)|0.09|STANDARD_ERROR_OF_MEAN|0.542|||TWO_SIDED|90.0|-0.81|0.99||||||Week 8-HSS0102-Tenderness At It's Worst||0.99|-0.81|
72470775|NCT04092452|144465188|SUPERIORITY||Risk Difference (RD)|-0.25|STANDARD_ERROR_OF_MEAN|0.523|||TWO_SIDED|90.0|-1.11|0.62||||||Week 8-HSS0102-Tenderness At It's Worst||0.62|-1.11|
72470776|NCT04092452|144465188|SUPERIORITY||Risk Difference (RD)|0.35|STANDARD_ERROR_OF_MEAN|0.549|||TWO_SIDED|90.0|-0.56|1.25||||||Week 8-HSS0102-Tenderness At It's Worst||1.25|-0.56|
72470777|NCT04092452|144465188|SUPERIORITY||Risk Difference (RD)|0.05|STANDARD_ERROR_OF_MEAN|0.554|||TWO_SIDED|90.0|-0.87|0.97||||||Week 12-HSS0102-Tenderness At It's Worst||0.97|-0.87|
72505300|NCT03237845|144541596|SUPERIORITY||Risk Difference (RD)|15.3|||<|0.0001|TWO_SIDED|95.0|9.4|21.2|||Cochran-Mantel-Haenszel|||||21.2|9.4|< 0.0001
72505301|NCT03237845|144541597|SUPERIORITY||Risk Difference (RD)|4.8||||0.2084|TWO_SIDED|95.0|-2.7|12.2||P-Value ≥ 0.05; therefore, all secondary outcome measures listed after this outcome measure in the hierarchy were not tested.|Cochran-Mantel-Haenszel|||||12.2|-2.7|0.2084
72505302|NCT03865407|144541616|SUPERIORITY|||||||0.1839|||||||t-test, 2 sided|||||||0.1839
72505303|NCT03865407|144541617|SUPERIORITY|||||||0.3036|||||||t-test, 2 sided|||||||0.3036
72505304|NCT03865407|144541618|SUPERIORITY|||||||0.0001|||||||t-test, 2 sided|||||||0.0001
72505305|NCT03865407|144541619|SUPERIORITY|||||||0.1421|||||||t-test, 2 sided|||||||0.1421
72622648|NCT00561821|144775377|SUPERIORITY_OR_OTHER|||||||0.0316||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA|||||||0.0316
72395299|NCT01571427|144297236|EQUIVALENCE|Power calculation was based on the entire sample which combined CDR=0 and CDR=0.5 groups. Analyses by each CDR group are exploratory.|Mean Difference (Final Values)|0.52|STANDARD_ERROR_OF_MEAN|1.14||0.65|TWO_SIDED||||||Regression, Linear||Estimates reported here is coefficient for the experimental group (with the control group as a reference), using a linear regression model controlling for Geriatric Depression Scale - 15 items version (GDS-15).|Analyses 3: CDR=0.5 (Mild Cognitive Impairment) group, N=34||||0.65
72395300|NCT01571427|144297237|EQUIVALENCE|It was calculated that 82 participants randomized in a 1:1 fashion between the 2 arms would have at least 80% to detect a Cohen's D of 0.45 in the difference in changes from baseline to week 6 at alpha=0.05 (two tailed). All randomized participants (n=83) were included in the analysis.|Mean Difference (Final Values)|0.03|STANDARD_ERROR_OF_MEAN|1.33||0.98|TWO_SIDED||||||Regression, Linear||Estimates reported here is coefficient for the experimental group (with the control group as a reference), using a linear regression model controlling for Geriatric Depression Scale - 15 items version (GDS-15).|||||0.98
72395301|NCT01571427|144297237|EQUIVALENCE|Power calculation was based on the entire sample which combined CDR=0 and CDR=0.5 groups. Analyses by each CDR group are exploratory.|Mean Difference (Final Values)|-0.09|STANDARD_ERROR_OF_MEAN|1.63||0.96|TWO_SIDED||||||Regression, Linear||Estimates reported here is coefficient for the experimental group (with the control group as a reference), using a linear regression model controlling for Geriatric Depression Scale - 15 items version (GDS-15).|Analysis 2: Among CDR 0 (n=49)||||0.96
72395302|NCT01571427|144297237|EQUIVALENCE|Power calculation was based on the entire sample which combined CDR=0 and CDR=0.5 groups. Analyses by each CDR group are exploratory.|Mean Difference (Final Values)|0.51|STANDARD_ERROR_OF_MEAN|2.38||0.83|TWO_SIDED||||||Regression, Linear||Estimates reported here is coefficient for the experimental group (with the control group as a reference), using a linear regression model controlling for Geriatric Depression Scale - 15 items version (GDS-15).|Analysis 3: Among CDR 0.5 (n=34)||||0.83
72395303|NCT01571427|144297238|EQUIVALENCE|It was calculated that 82 participants randomized in a 1:1 fashion between the 2 arms would have at least 80% to detect a Cohen's D of 0.45 in the difference in changes from baseline to week 6 at alpha=0.05 (two tailed). All randomized participants (n=83) were included in the analysis.|Mean Difference (Final Values)|-0.27|STANDARD_ERROR_OF_MEAN|0.64||0.68|TWO_SIDED||||||Regression, Linear||Estimates reported here is coefficient for the experimental group (with the control group as a reference), using a linear regression model controlling for Geriatric Depression Scale - 15 items version (GDS-15).|||||0.68
72395304|NCT01571427|144297238|EQUIVALENCE|Power calculation was based on the entire sample which combined CDR=0 and CDR=0.5 groups. Analyses by each CDR group are exploratory.|Mean Difference (Final Values)|-0.34|STANDARD_ERROR_OF_MEAN|0.84||0.69|TWO_SIDED||||||Regression, Linear||Estimates reported here is coefficient for the experimental group (with the control group as a reference), using a linear regression model controlling for Geriatric Depression Scale - 15 items version (GDS-15).|Analysis 2: CDR 0 (n=49)||||0.69
72470778|NCT04092452|144465188|SUPERIORITY||Risk Difference (RD)|-0.49|STANDARD_ERROR_OF_MEAN|0.527|||TWO_SIDED|90.0|-1.36|0.38||||||Week 12-HSS0102-Tenderness At It's Worst||0.38|-1.36|
72470779|NCT04092452|144465188|SUPERIORITY||Risk Difference (RD)|0.02|STANDARD_ERROR_OF_MEAN|0.552|||TWO_SIDED|90.0|-0.9|0.93||||||Week 12-HSS0102-Tenderness At It's Worst||0.93|-0.90|
72470780|NCT04092452|144465188|SUPERIORITY||Risk Difference (RD)|0.04|STANDARD_ERROR_OF_MEAN|0.606|||TWO_SIDED|90.0|-0.96|1.04||||||Week 16-HSS0102-Tenderness At It's Worst||1.04|-0.96|
72470781|NCT04092452|144465188|SUPERIORITY||Risk Difference (RD)|-1.24|STANDARD_ERROR_OF_MEAN|0.577|||TWO_SIDED|90.0|-2.19|-0.29||||||Week 16-HSS0102-Tenderness At It's Worst||-0.29|-2.19|
72470782|NCT04092452|144465188|SUPERIORITY||Risk Difference (RD)|-1.11|STANDARD_ERROR_OF_MEAN|0.603|||TWO_SIDED|90.0|-2.11|-0.11||||||Week 16-HSS0102-Tenderness At It's Worst||-0.11|-2.11|
72470783|NCT04092452|144465188|SUPERIORITY||Risk Difference (RD)|-0.1|STANDARD_ERROR_OF_MEAN|0.284|||TWO_SIDED|90.0|-0.57|0.37||||||Week 1-HSS0103-Swelling At It's Worst||0.37|-0.57|
72470784|NCT04092452|144465188|SUPERIORITY||Risk Difference (RD)|-0.23|STANDARD_ERROR_OF_MEAN|0.278|||TWO_SIDED|90.0|-0.69|0.22||||||Week 1-HSS0103-Swelling At It's Worst||0.22|-0.69|
72470785|NCT04092452|144465188|SUPERIORITY||Risk Difference (RD)|-0.47|STANDARD_ERROR_OF_MEAN|0.285|||TWO_SIDED|90.0|-0.94|0.01||||||Week 1-HSS0103-Swelling At It's Worst||0.01|-0.94|
72470786|NCT04092452|144465188|SUPERIORITY||Risk Difference (RD)|-0.24|STANDARD_ERROR_OF_MEAN|0.357|||TWO_SIDED|90.0|-0.83|0.35||||||Week 2-HSS0103-Swelling At It's Worst||0.35|-0.83|
72470787|NCT04092452|144465188|SUPERIORITY||Risk Difference (RD)|-0.46|STANDARD_ERROR_OF_MEAN|0.345|||TWO_SIDED|90.0|-1.03|0.11||||||Week 2-HSS0103-Swelling At It's Worst||0.11|-1.03|
72470788|NCT04092452|144465188|SUPERIORITY||Risk Difference (RD)|-0.4|STANDARD_ERROR_OF_MEAN|0.357|||TWO_SIDED|90.0|-0.99|0.19||||||Week 2-HSS0103-Swelling At It's Worst||0.19|-0.99|
72470789|NCT04092452|144465188|SUPERIORITY||Risk Difference (RD)|0.16|STANDARD_ERROR_OF_MEAN|0.446|||TWO_SIDED|90.0|-0.58|0.9||||||Week 4-HSS0103-Swelling At It's Worst||0.90|-0.58|
72470790|NCT04092452|144465188|SUPERIORITY||Risk Difference (RD)|-0.17|STANDARD_ERROR_OF_MEAN|0.424|||TWO_SIDED|90.0|-0.87|0.53||||||Week 4-HSS0103-Swelling At It's Worst||0.53|-0.87|
72470791|NCT04092452|144465188|SUPERIORITY||Risk Difference (RD)|0.09|STANDARD_ERROR_OF_MEAN|0.443|||TWO_SIDED|90.0|-0.65|0.82||||||Week 4-HSS0103-Swelling At It's Worst||0.82|-0.65|
72470792|NCT04092452|144465188|SUPERIORITY||Risk Difference (RD)|0.7|STANDARD_ERROR_OF_MEAN|0.51|||TWO_SIDED|90.0|-0.15|1.54||||||Week 6-HSS0103-Swelling At It's Worst||1.54|-0.15|
72470793|NCT04092452|144465188|SUPERIORITY||Risk Difference (RD)|-0.02|STANDARD_ERROR_OF_MEAN|0.493|||TWO_SIDED|90.0|-0.83|0.8||||||Week 6-HSS0103-Swelling At It's Worst||0.80|-0.83|
72470794|NCT04092452|144465188|SUPERIORITY||Risk Difference (RD)|0.23|STANDARD_ERROR_OF_MEAN|0.513|||TWO_SIDED|90.0|-0.62|1.08||||||Week 6-HSS0103-Swelling At It's Worst||1.08|-0.62|
72470795|NCT04092452|144465188|SUPERIORITY||Risk Difference (RD)|0.29|STANDARD_ERROR_OF_MEAN|0.507|||TWO_SIDED|90.0|-0.55|1.13||||||Week 8-HSS0103-Swelling At It's Worst||1.13|-0.55|
72470796|NCT04092452|144465188|SUPERIORITY||Risk Difference (RD)|0.0|STANDARD_ERROR_OF_MEAN|0.489|||TWO_SIDED|90.0|-0.81|0.81||||||Week 8-HSS0103-Swelling At It's Worst||0.81|-0.81|
72470797|NCT04092452|144465188|SUPERIORITY||Risk Difference (RD)|0.5|STANDARD_ERROR_OF_MEAN|0.514|||TWO_SIDED|90.0|-0.35|1.35||||||Week 8-HSS0103-Swelling At It's Worst||1.35|-0.35|
72470798|NCT04092452|144465188|SUPERIORITY||Risk Difference (RD)|0.07|STANDARD_ERROR_OF_MEAN|0.532|||TWO_SIDED|90.0|-0.81|0.95||||||Week 12-HSS0103-Swelling At It's Worst||0.95|-0.81|
72470799|NCT04092452|144465188|SUPERIORITY||Risk Difference (RD)|-0.47|STANDARD_ERROR_OF_MEAN|0.505|||TWO_SIDED|90.0|-1.3|0.37||||||Week 12-HSS0103-Swelling At It's Worst||0.37|-1.30|
72395305|NCT01571427|144297238|EQUIVALENCE|Power calculation was based on the entire sample which combined CDR=0 and CDR=0.5 groups. Analyses by each CDR group are exploratory.|Mean Difference (Final Values)|-0.18|STANDARD_ERROR_OF_MEAN|1.02||0.86|TWO_SIDED||||||Regression, Linear||Estimates reported here is coefficient for the experimental group (with the control group as a reference), using a linear regression model controlling for Geriatric Depression Scale - 15 items version (GDS-15).|Analysis 3: CDR 0.5 (n=34)||||0.86
72470800|NCT04092452|144465188|SUPERIORITY||Risk Difference (RD)|-0.04|STANDARD_ERROR_OF_MEAN|0.53|||TWO_SIDED|90.0|-0.92|0.84||||||Week 12-HSS0103-Swelling At It's Worst||0.84|-0.92|
72470801|NCT04092452|144465188|SUPERIORITY||Risk Difference (RD)|0.23|STANDARD_ERROR_OF_MEAN|0.589|||TWO_SIDED|90.0|-0.75|1.2||||||Week 16-HSS0103-Swelling At It's Worst||1.20|-0.75|
72470802|NCT04092452|144465188|SUPERIORITY||Risk Difference (RD)|-1.06|STANDARD_ERROR_OF_MEAN|0.561|||TWO_SIDED|90.0|-1.99|-0.13||||||Week 16-HSS0103-Swelling At It's Worst||-0.13|-1.99|
72470803|NCT04092452|144465188|SUPERIORITY||Risk Difference (RD)|-1.02|STANDARD_ERROR_OF_MEAN|0.586|||TWO_SIDED|90.0|-1.99|-0.05||||||Week 16-HSS0103-Swelling At It's Worst||-0.05|-1.99|
72470804|NCT04092452|144465188|SUPERIORITY||Risk Difference (RD)|0.16|STANDARD_ERROR_OF_MEAN|0.262|||TWO_SIDED|90.0|-0.27|0.59||||||Week 1-HSS0104-Tiredness At It's Worst||0.59|-0.27|
72470805|NCT04092452|144465188|SUPERIORITY||Risk Difference (RD)|-0.57|STANDARD_ERROR_OF_MEAN|0.255|||TWO_SIDED|90.0|-0.99|-0.15||||||Week 1-HSS0104-Tiredness At It's Worst||-0.15|-0.99|
72470806|NCT04092452|144465188|SUPERIORITY||Risk Difference (RD)|0.09|STANDARD_ERROR_OF_MEAN|0.262|||TWO_SIDED|90.0|-0.35|0.52||||||Week 1-HSS0104-Tiredness At It's Worst||0.52|-0.35|
72470807|NCT04092452|144465188|SUPERIORITY||Risk Difference (RD)|0.06|STANDARD_ERROR_OF_MEAN|0.357|||TWO_SIDED|90.0|-0.54|0.65||||||Week 2-HSS0104-Tiredness At It's Worst||0.65|-0.54|
72470808|NCT04092452|144465188|SUPERIORITY||Risk Difference (RD)|-0.44|STANDARD_ERROR_OF_MEAN|0.344|||TWO_SIDED|90.0|-1.01|0.13||||||Week 2-HSS0104-Tiredness At It's Worst||0.13|-1.01|
72470809|NCT04092452|144465188|SUPERIORITY||Risk Difference (RD)|0.26|STANDARD_ERROR_OF_MEAN|0.356|||TWO_SIDED|90.0|-0.33|0.85||||||Week 2-HSS0104-Tiredness At It's Worst||0.85|-0.33|
72470810|NCT04092452|144465188|SUPERIORITY||Risk Difference (RD)|-0.12|STANDARD_ERROR_OF_MEAN|0.434|||TWO_SIDED|90.0|-0.83|0.6||||||Week 4-HSS0104-Tiredness At It's Worst||0.60|-0.83|
72470811|NCT04092452|144465188|SUPERIORITY||Risk Difference (RD)|-0.81|STANDARD_ERROR_OF_MEAN|0.414|||TWO_SIDED|90.0|-1.49|-0.12||||||Week 4-HSS0104-Tiredness At It's Worst||-0.12|-1.49|
72470812|NCT04092452|144465188|SUPERIORITY||Risk Difference (RD)|-0.14|STANDARD_ERROR_OF_MEAN|0.431|||TWO_SIDED|90.0|-0.86|0.57||||||Week 4-HSS0104-Tiredness At It's Worst||0.57|-0.86|
72470813|NCT04092452|144465188|SUPERIORITY||Risk Difference (RD)|0.04|STANDARD_ERROR_OF_MEAN|0.483|||TWO_SIDED|90.0|-0.76|0.84||||||Week 6-HSS0104-Tiredness At It's Worst||0.84|-0.76|
72470814|NCT04092452|144465188|SUPERIORITY||Risk Difference (RD)|-0.52|STANDARD_ERROR_OF_MEAN|0.466|||TWO_SIDED|90.0|-1.29|0.26||||||Week 6-HSS0104-Tiredness At It's Worst||0.26|-1.29|
72470815|NCT04092452|144465188|SUPERIORITY||Risk Difference (RD)|0.12|STANDARD_ERROR_OF_MEAN|0.485|||TWO_SIDED|90.0|-0.68|0.92||||||Week 6-HSS0104-Tiredness At It's Worst||0.92|-0.68|
72470816|NCT04092452|144465188|SUPERIORITY||Risk Difference (RD)|-0.17|STANDARD_ERROR_OF_MEAN|0.483|||TWO_SIDED|90.0|-0.96|0.63||||||Week 8-HSS0104-Tiredness At It's Worst||0.63|-0.96|
72470817|NCT04092452|144465188|SUPERIORITY||Risk Difference (RD)|-0.53|STANDARD_ERROR_OF_MEAN|0.466|||TWO_SIDED|90.0|-1.31|0.24||||||Week 8-HSS0104-Tiredness At It's Worst||0.24|-1.31|
72470818|NCT04092452|144465188|SUPERIORITY||Risk Difference (RD)|0.11|STANDARD_ERROR_OF_MEAN|0.488|||TWO_SIDED|90.0|-0.69|0.92||||||Week 8-HSS0104-Tiredness At It's Worst||0.92|-0.69|
72470819|NCT04092452|144465188|SUPERIORITY||Risk Difference (RD)|-0.34|STANDARD_ERROR_OF_MEAN|0.527|||TWO_SIDED|90.0|-1.21|0.53||||||Week 12-HSS0104-Tiredness At It's Worst||0.53|-1.21|
72470820|NCT04092452|144465188|SUPERIORITY||Risk Difference (RD)|-0.81|STANDARD_ERROR_OF_MEAN|0.503|||TWO_SIDED|90.0|-1.64|0.02||||||Week 12-HSS0104-Tiredness At It's Worst||0.02|-1.64|
72470821|NCT04092452|144465188|SUPERIORITY||Risk Difference (RD)|0.15|STANDARD_ERROR_OF_MEAN|0.527|||TWO_SIDED|90.0|-0.72|1.02||||||Week 12-HSS0104-Tiredness At It's Worst||1.02|-0.72|
72470822|NCT04092452|144465188|SUPERIORITY||Risk Difference (RD)|0.22|STANDARD_ERROR_OF_MEAN|0.559|||TWO_SIDED|90.0|-0.7|1.15||||||Week 16-HSS0104-Tiredness At It's Worst||1.15|-0.70|
72470823|NCT04092452|144465188|SUPERIORITY||Risk Difference (RD)|-0.56|STANDARD_ERROR_OF_MEAN|0.532|||TWO_SIDED|90.0|-1.44|0.32||||||Week 16-HSS0104-Tiredness At It's Worst||0.32|-1.44|
72470824|NCT04092452|144465188|SUPERIORITY||Risk Difference (RD)|0.09|STANDARD_ERROR_OF_MEAN|0.557|||TWO_SIDED|90.0|-0.83|1.01||||||Week 16-HSS0104-Tiredness At It's Worst||1.01|-0.83|
72470825|NCT04092452|144465188|SUPERIORITY||Risk Difference (RD)|0.05|STANDARD_ERROR_OF_MEAN|0.264|||TWO_SIDED|90.0|-0.39|0.49||||||Week 1-HSS0105-Bothered By Appearance HS Lesion||0.49|-0.39|
72470826|NCT04092452|144465188|SUPERIORITY||Risk Difference (RD)|-0.32|STANDARD_ERROR_OF_MEAN|0.257|||TWO_SIDED|90.0|-0.75|0.1||||||Week 1-HSS0105-Bothered By Appearance HS Lesion||0.10|-0.75|
72470827|NCT04092452|144465188|SUPERIORITY||Risk Difference (RD)|-0.02|STANDARD_ERROR_OF_MEAN|0.266|||TWO_SIDED|90.0|-0.46|0.42||||||Week 1-HSS0105-Bothered By Appearance HS Lesion||0.42|-0.46|
72470828|NCT04092452|144465188|SUPERIORITY||Risk Difference (RD)|-0.1|STANDARD_ERROR_OF_MEAN|0.333|||TWO_SIDED|90.0|-0.65|0.45||||||Week 2-HSS0105-Bothered By Appearance HS Lesion||0.45|-0.65|
72470829|NCT04092452|144465188|SUPERIORITY||Risk Difference (RD)|-0.8|STANDARD_ERROR_OF_MEAN|0.321|||TWO_SIDED|90.0|-1.33|-0.27||||||Week 2-HSS0105-Bothered By Appearance HS Lesion||-0.27|-1.33|
72470830|NCT04092452|144465188|SUPERIORITY||Risk Difference (RD)|-0.36|STANDARD_ERROR_OF_MEAN|0.333|||TWO_SIDED|90.0|-0.91|0.19||||||Week 2-HSS0105-Bothered By Appearance HS Lesion||0.19|-0.91|
72470831|NCT04092452|144465188|SUPERIORITY||Risk Difference (RD)|0.32|STANDARD_ERROR_OF_MEAN|0.411|||TWO_SIDED|90.0|-0.36|1.0||||||Week 4-HSS0105-Bothered By Appearance HS Lesion||1.00|-0.36|
72470832|NCT04092452|144465188|SUPERIORITY||Risk Difference (RD)|-0.94|STANDARD_ERROR_OF_MEAN|0.393|||TWO_SIDED|90.0|-1.59|-0.29||||||Week 4-HSS0105-Bothered By Appearance HS Lesion||-0.29|-1.59|
72470833|NCT04092452|144465188|SUPERIORITY||Risk Difference (RD)|-0.29|STANDARD_ERROR_OF_MEAN|0.411|||TWO_SIDED|90.0|-0.97|0.39||||||Week 4-HSS0105-Bothered By Appearance HS Lesion||0.39|-0.97|
72470834|NCT04092452|144465188|SUPERIORITY||Risk Difference (RD)|0.55|STANDARD_ERROR_OF_MEAN|0.454|||TWO_SIDED|90.0|-0.2|1.3||||||Week 6-HSS0105-Bothered By Appearance HS Lesion||1.30|-0.20|
72470835|NCT04092452|144465188|SUPERIORITY||Risk Difference (RD)|-0.69|STANDARD_ERROR_OF_MEAN|0.439|||TWO_SIDED|90.0|-1.41|0.04||||||Week 6-HSS0105-Bothered By Appearance HS Lesion||0.04|-1.41|
72505306|NCT03865407|144541620|SUPERIORITY|||||||0.0022|||||||t-test, 2 sided|||||||0.0022
72395306|NCT01571427|144297239|EQUIVALENCE|It was calculated that 82 participants randomized in a 1:1 fashion between the 2 arms would have at least 80% to detect a Cohen's D of 0.45 in the difference in changes from baseline to week 6 at alpha=0.05 (two tailed). All randomized participants (n=83) were included in the analysis.|Mean Difference (Final Values)|-0.04|STANDARD_ERROR_OF_MEAN|0.43||0.92|TWO_SIDED||||||Regression, Linear||Estimates reported here is coefficient for the experimental group (with the control group as a reference), using a linear regression model controlling for Geriatric Depression Scale - 15 items version (GDS-15).|||||0.92
72565564|NCT03028740|144662394|SUPERIORITY||Odds Ratio (OR)|0.8877|||||TWO_SIDED|95.0|0.6709|1.1744|||||Odds Ratio was based on Mantel-Haenszel estimates comparing Cenicriviroc vs Placebo, controlling for factors (randomization strata: fibrosis stage \[2 vs 3\] and presence or absence of T2DM at Baseline).|||1.1744|0.6709|
72565565|NCT04060719|144662404|OTHER|No formal hypotheses were tested.|Adjusted Geometric Mean Ratio T/R [%]|10.48|||||TWO_SIDED|90.0|9.74|11.28|||Mixed Models Analysis|Mixed effects model on the logarithmic scale including effects for 'subject' (random) and 'treatment' (fixed).|Confidence intervals were calculated based on the residual error from the mixed effects model. Ratio is calculated as Test/Reference. Intra-individual geometric coefficient of variation (gCV) = 11.8.|Relative bioavailability||11.28|9.74|
72565566|NCT04060719|144662405|OTHER|No formal hypotheses were tested.|Adjusted Geometric Mean Ratio T/R [%]|30.03|||||TWO_SIDED|90.0|25.76|35.02|||Mixed Models Analysis|Mixed effects model on the logarithmic scale including effects for 'subject' (random) and 'treatment' (fixed).|Confidence intervals were calculated based on the residual error from the mixed effects model. Ratio is calculated as Test/Reference. Intra-individual geometric coefficient of variation (gCV) = 25.2.|Relative bioavailability||35.02|25.76|
72565567|NCT04060719|144662406|OTHER|No formal hypotheses were tested.|Adjusted Geometric Mean Ratio T/R [%]|10.39|||||TWO_SIDED|90.0|9.66|11.18|||Mixed Models Analysis|Mixed effects model on the logarithmic scale including effects for 'subject' (random) and 'treatment' (fixed).|Confidence intervals were calculated based on the residual error from the mixed effects model. Ratio is calculated as Test/Reference. Intra-individual geometric coefficient of variation (gCV) = 11.8.|Relative bioavailability||11.18|9.66|
72395307|NCT01571427|144297239|EQUIVALENCE|Power calculation was based on the entire sample which combined CDR=0 and CDR=0.5 groups. Analyses by each CDR group are exploratory.|Mean Difference (Final Values)|0.06|STANDARD_ERROR_OF_MEAN|0.61||0.92|TWO_SIDED||||||Regression, Linear||Estimates reported here is coefficient for the experimental group (with the control group as a reference), using a linear regression model controlling for Geriatric Depression Scale - 15 items version (GDS-15).|Analysis 2: CDR 0 (n=49)||||0.92
72565568|NCT04578886|144662407|SUPERIORITY||Mean Difference (Final Values)|3.4|STANDARD_DEVIATION|3.7||0.22|TWO_SIDED|95.0|2.3|4.4|||t-test, 2 sided|||||4.4|2.3|0.22
72470836|NCT04092452|144465188|SUPERIORITY||Risk Difference (RD)|-0.1|STANDARD_ERROR_OF_MEAN|0.456|||TWO_SIDED|90.0|-0.85|0.66||||||Week 6-HSS0105-Bothered By Appearance HS Lesion||0.66|-0.85|
72565569|NCT04578886|144662407|SUPERIORITY||Risk Ratio (RR)|1.3307||||0.015|TWO_SIDED|95.0|1.0571|1.6751||unadjusted for covariates|Regression, Linear|||"Null Hypothesis: The administration of guanfacine in critically ill patients in the intensive unit has no effect on the duration of delirium.~Continuous variables will be summarized using sample mean and sample variance whereas categorical variables will be summarized as proportions. Logistic regression models will examine whether age, gender, or comorbities associated with incidence of delirium when Guanfacine is administered."||1.6751|1.0571|0.0150
72565570|NCT03998436|144662420|SUPERIORITY||Odds Ratio (OR)|2.126||||0.0276|TWO_SIDED|95.0|1.08|4.17|||Chi-squared|||||4.17|1.08|0.0276
72565571|NCT03998436|144662421|SUPERIORITY||Odds Ratio (OR)|2.708||||0.0126|TWO_SIDED|95.0|1.22|5.99|||Chi-squared|||||5.99|1.22|0.0126
72565572|NCT00285584|144662587|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|1.5||||0.9|||||||Wilcoxon (Mann-Whitney)|||||||0.9
72565573|NCT00285584|144662588|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.5||||0.3|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon rank test||||0.3
72565574|NCT00285584|144662589|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|3.15||||0.3|TWO_SIDED|95.0|0.4|27.8|||Fisher Exact|||Comparison of cumulative incidence proportions||27.8|0.4|0.3
72565575|NCT00285584|144662590|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-2.5||||0.19|||||||Wilcoxon (Mann-Whitney)|||||||0.19
72565576|NCT04844021|144662595|OTHER|We used a multiple hypothesis testing framework to evaluate the effectiveness of Nudge+ vs. Nudge, considering: 1) Nudge+ is more effective than Nudge by over 10 percentage points (PP); 2) Nudge+ is as effective as Nudge, with a difference of no greater than 10 PP in either direction; and 3) Nudge+ is less effective than Nudge by over 10 PP. The 10 PP margin was selected based on discussions with health system leaders and previous studies to ensure the differences were clinically meaningful.|Marginal probability|0.22|||||TWO_SIDED|95.0|0.13|0.31||If the 95% confidence interval for the risk difference did not contain any values within a region (Nudge+ superior, equivalence, Nudge+ inferior), that region could be rejected.||||The primary analysis involved fitting generalized estimating equations (GEE) with a binomial distribution and logit link to estimate reach (primary endpoint) for Nudge and Nudge+ along with the risk difference between conditions.||0.31|0.13|
72565577|NCT04844021|144662595|OTHER|We used a multiple hypothesis testing framework to evaluate the effectiveness of Nudge+ vs. Nudge, considering: 1) Nudge+ is more effective than Nudge by over 10 percentage points (PP); 2) Nudge+ is as effective as Nudge, with a difference of no greater than 10 PP in either direction; and 3) Nudge+ is less effective than Nudge by over 10 PP. The 10 PP margin was selected based on discussions with health system leaders and previous studies to ensure the differences were clinically meaningful.|Marginal probability|0.49|||||TWO_SIDED|95.0|0.37|0.61||If the 95% confidence interval for the risk difference did not contain any values within a region (Nudge+ superior, equivalence, Nudge+ inferior), that region could be rejected.||||The primary analysis involved fitting generalized estimating equations (GEE) with a binomial distribution and logit link to estimate reach (primary endpoint) for Nudge and Nudge+ along with the risk difference between conditions.||0.61|0.37|
72565578|NCT01258101|144662627|NON_INFERIORITY_OR_EQUIVALENCE|The statistical analysis was applied to Arms Peginterferon/Ribavirin 800 mg (16 weeks) and Peginterferon/Ribavirin 400 mg (16 weeks).|Risk Difference (RD)|32.0|||||TWO_SIDED|95.0|10.5|53.5||||||||53.5|10.5|
72565579|NCT01258101|144662627|NON_INFERIORITY_OR_EQUIVALENCE|The statistical analysis was applied to arms Peginterferon/Ribavirin 800 mg (24 weeks) and Peginterferon/Ribavirin 400 mg (24 weeks).|Risk Difference (RD)|-3.2|||||TWO_SIDED|95.0|-14.0|7.6||||||||7.6|-14.0|
72622649|NCT00561821|144775377|SUPERIORITY_OR_OTHER|||||||0.0014||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA|||||||0.0014
72622650|NCT02657356|144775399|SUPERIORITY||LS Mean difference (Net)|-12.86|STANDARD_ERROR_OF_MEAN|7.012||0.0683|TWO_SIDED|95.0|-26.69|0.98|||Mixed Models Analysis|Covariates: screening 6MWT, day 1 hemoglobin, treatment grp, # of PAH medications, time, interactions btwn treatment \& time, and screening 6MWT \& time|Difference is bardoxolone methyl - placebo|||0.98|-26.69|0.0683
72470837|NCT04092452|144465188|SUPERIORITY||Risk Difference (RD)|-0.15|STANDARD_ERROR_OF_MEAN|0.491|||TWO_SIDED|90.0|-0.96|0.66||||||Week 8-HSS0105-Bothered By Appearance HS Lesion||0.66|-0.96|
72505307|NCT03865407|144541621|SUPERIORITY|||||||0.3032|||||||t-test, 2 sided|||||||0.3032
72470838|NCT04092452|144465188|SUPERIORITY||Risk Difference (RD)|-1.11|STANDARD_ERROR_OF_MEAN|0.473|||TWO_SIDED|90.0|-1.89|-0.33||||||Week 8-HSS0105-Bothered By Appearance HS Lesion||-0.33|-1.89|
72470839|NCT04092452|144465188|SUPERIORITY||Risk Difference (RD)|-0.3|STANDARD_ERROR_OF_MEAN|0.497|||TWO_SIDED|90.0|-1.13|0.52||||||Week 8-HSS0105-Bothered By Appearance HS Lesion||0.52|-1.13|
72470840|NCT04092452|144465188|SUPERIORITY||Risk Difference (RD)|0.05|STANDARD_ERROR_OF_MEAN|0.547|||TWO_SIDED|90.0|-0.86|0.95||||||Week 12-HSS0105-Bothered By Appearance HS Lesion||0.95|-0.86|
72470841|NCT04092452|144465188|SUPERIORITY||Risk Difference (RD)|-0.87|STANDARD_ERROR_OF_MEAN|0.523|||TWO_SIDED|90.0|-1.73|-0.01||||||Week 12-HSS0105-Bothered By Appearance HS Lesion||-0.01|-1.73|
72470842|NCT04092452|144465188|SUPERIORITY||Risk Difference (RD)|0.12|STANDARD_ERROR_OF_MEAN|0.547|||TWO_SIDED|90.0|-0.78|1.03||||||Week 12-HSS0105-Bothered By Appearance HS Lesion||1.03|-0.78|
72470843|NCT04092452|144465188|SUPERIORITY||Risk Difference (RD)|0.39|STANDARD_ERROR_OF_MEAN|0.602|||TWO_SIDED|90.0|-0.6|1.39||||||Week 16-HSS0105-Bothered By Appearance HS Lesion||1.39|-0.60|
72470844|NCT04092452|144465188|SUPERIORITY||Risk Difference (RD)|-0.95|STANDARD_ERROR_OF_MEAN|0.574|||TWO_SIDED|90.0|-1.9|0.0||||||Week 16-HSS0105-Bothered By Appearance HS Lesion||0.00|-1.90|
72470845|NCT04092452|144465188|SUPERIORITY||Risk Difference (RD)|-0.01|STANDARD_ERROR_OF_MEAN|0.6|||TWO_SIDED|90.0|-1.0|0.99||||||Week 16-HSS0105-Bothered By Appearance HS Lesion||0.99|-1.00|
72505308|NCT01645280|144541637|SUPERIORITY_OR_OTHER|||||||0.184|||||||Cochran-Mantel-Haenszel|Screening CRP level (\>= 1.50 mg/dL; \< 1.50 mg/dL) was used as stratification factors.||||||0.184
72505309|NCT01645280|144541637|SUPERIORITY_OR_OTHER|||||||0.13|||||||Cochran-Mantel-Haenszel|Screening CRP level (\>= 1.50 mg/dL; \< 1.50 mg/dL) was used as stratification factors.||||||0.130
72470846|NCT04092452|144465189|SUPERIORITY||Risk Difference (RD)|0.4|STANDARD_ERROR_OF_MEAN|1.32|||TWO_SIDED|90.0|-1.7|2.6||||||Week 4||2.6|-1.7|
72470847|NCT04092452|144465189|SUPERIORITY||Risk Difference (RD)|-0.5|STANDARD_ERROR_OF_MEAN|1.32|||TWO_SIDED|90.0|-2.7|1.7||||||Week 4||1.7|-2.7|
72470848|NCT04092452|144465189|SUPERIORITY||Risk Difference (RD)|0.9|STANDARD_ERROR_OF_MEAN|1.38|||TWO_SIDED|90.0|-1.4|3.2||||||Week 4||3.2|-1.4|
72470849|NCT04092452|144465189|SUPERIORITY||Risk Difference (RD)|-0.5|STANDARD_ERROR_OF_MEAN|1.31|||TWO_SIDED|90.0|-2.7|1.6||||||Week 8||1.6|-2.7|
72470850|NCT04092452|144465189|SUPERIORITY||Risk Difference (RD)|-1.1|STANDARD_ERROR_OF_MEAN|1.29|||TWO_SIDED|90.0|-3.3|1.0||||||Week 8||1.0|-3.3|
72470851|NCT04092452|144465189|SUPERIORITY||Risk Difference (RD)|0.0|STANDARD_ERROR_OF_MEAN|1.34|||TWO_SIDED|90.0|-2.2|2.2||||||Week 8||2.2|-2.2|
72470852|NCT04092452|144465189|SUPERIORITY||Risk Difference (RD)|-0.8|STANDARD_ERROR_OF_MEAN|1.44|||TWO_SIDED|90.0|-3.2|1.6||||||Week 12||1.6|-3.2|
72470853|NCT04092452|144465189|SUPERIORITY||Risk Difference (RD)|-2.0|STANDARD_ERROR_OF_MEAN|1.39|||TWO_SIDED|90.0|-4.3|0.3||||||Week 12||0.3|-4.3|
72470854|NCT04092452|144465189|SUPERIORITY||Risk Difference (RD)|-0.2|STANDARD_ERROR_OF_MEAN|1.45|||TWO_SIDED|90.0|-2.6|2.2||||||Week 12||2.2|-2.6|
72470855|NCT04092452|144465189|SUPERIORITY||Risk Difference (RD)|1.7|STANDARD_ERROR_OF_MEAN|1.5|||TWO_SIDED|90.0|-0.7|4.2||||||Week 16||4.2|-0.7|
72470856|NCT04092452|144465189|SUPERIORITY||Risk Difference (RD)|-1.2|STANDARD_ERROR_OF_MEAN|1.45|||TWO_SIDED|90.0|-3.6|1.2||||||Week 16||1.2|-3.6|
72470857|NCT04092452|144465189|SUPERIORITY||Risk Difference (RD)|0.1|STANDARD_ERROR_OF_MEAN|1.51|||TWO_SIDED|90.0|-2.4|2.6||||||Week 16||2.6|-2.4|
72470858|NCT04092452|144465190|SUPERIORITY||Risk Difference (RD)|0.4|STANDARD_ERROR_OF_MEAN|1.32|||TWO_SIDED|90.0|-1.7|2.6||||||Week 4||2.6|-1.7|
72470859|NCT04092452|144465190|SUPERIORITY||Risk Difference (RD)|-0.5|STANDARD_ERROR_OF_MEAN|1.32|||TWO_SIDED|90.0|-2.7|1.7||||||Week 4||1.7|-2.7|
72470860|NCT04092452|144465190|SUPERIORITY||Risk Difference (RD)|0.9|STANDARD_ERROR_OF_MEAN|1.38|||TWO_SIDED|90.0|-1.4|3.2||||||Week 4||3.2|-1.4|
72470861|NCT04092452|144465190|SUPERIORITY||Risk Difference (RD)|-0.5|STANDARD_ERROR_OF_MEAN|1.31|||TWO_SIDED|90.0|-2.7|1.6||||||Week 8||1.6|-2.7|
72470862|NCT04092452|144465190|SUPERIORITY||Risk Difference (RD)|-1.1|STANDARD_ERROR_OF_MEAN|1.29|||TWO_SIDED|90.0|-3.3|1.0||||||Week 8||1.0|-3.3|
72470863|NCT04092452|144465190|SUPERIORITY||Risk Difference (RD)|0.0|STANDARD_ERROR_OF_MEAN|1.34|||TWO_SIDED|90.0|-2.2|2.2||||||Week 8||2.2|-2.2|
72470864|NCT04092452|144465190|SUPERIORITY||Risk Difference (RD)|-0.8|STANDARD_ERROR_OF_MEAN|1.44|||TWO_SIDED|90.0|-3.2|1.6||||||Week 12||1.6|-3.2|
72505310|NCT01645280|144541637|SUPERIORITY_OR_OTHER|||||||0.642|||||||Cochran-Mantel-Haenszel|Screening CRP level (\>= 1.50 mg/dL; \< 1.50 mg/dL) was used as stratification factors.||||||0.642
72505311|NCT01645280|144541637|SUPERIORITY_OR_OTHER|||||||0.832|||||||Cochran-Mantel-Haenszel|Screening CRP level (\>= 1.50 mg/dL; \< 1.50 mg/dL) was used as stratification factors.||||||0.832
72505312|NCT01645280|144541638|SUPERIORITY_OR_OTHER|||||||0.019|||||||ANCOVA|Treatment, screening CRP level (\>=1.50 mg/dL, \<1.50mg/dL) and baseline score as covariates.||||||0.019
72505313|NCT01645280|144541638|SUPERIORITY_OR_OTHER|||||||0.025|||||||ANCOVA|Treatment, screening CRP level (\>=1.50 mg/dL, \<1.50mg/dL) and baseline score as covariates.||||||0.025
72505314|NCT01645280|144541638|SUPERIORITY_OR_OTHER|||||||0.248|||||||ANCOVA|Treatment, screening CRP level (\>=1.50 mg/dL, \<1.50mg/dL) and baseline score as covariates.||||||0.248
72622651|NCT02657356|144775400|SUPERIORITY||Hazard Ratio (HR)|1.984||||0.0004|TWO_SIDED|95.0|1.36|2.895|||Chi-squared||Estimated from Cox Regression adjusted by baseline PAH medication status (0-1 vs 2) as the covariate. Hazard ratio \>1 indicates a beneficial effect that favors bardoxolone methyl.|||2.895|1.360|0.0004
72470865|NCT04092452|144465190|SUPERIORITY||Risk Difference (RD)|-2.0|STANDARD_ERROR_OF_MEAN|1.39|||TWO_SIDED|90.0|-4.3|0.3||||||Week 12||0.3|-4.3|
72470866|NCT04092452|144465190|SUPERIORITY||Risk Difference (RD)|-0.2|STANDARD_ERROR_OF_MEAN|1.45|||TWO_SIDED|90.0|-2.6|2.2||||||Week 12||2.2|-2.6|
72470867|NCT04092452|144465190|SUPERIORITY||Risk Difference (RD)|1.7|STANDARD_ERROR_OF_MEAN|1.5|||TWO_SIDED|90.0|-0.7|4.2||||||Week 16||4.2|-0.7|
72470868|NCT04092452|144465190|SUPERIORITY||Risk Difference (RD)|-1.2|STANDARD_ERROR_OF_MEAN|1.45|||TWO_SIDED|90.0|-3.6|1.2||||||Week 16||1.2|-3.6|
72470869|NCT04092452|144465190|SUPERIORITY||Risk Difference (RD)|0.1|STANDARD_ERROR_OF_MEAN|1.51|||TWO_SIDED|90.0|-2.4|2.6||||||Week 16||2.6|-2.4|
72565580|NCT01258101|144662627|NON_INFERIORITY_OR_EQUIVALENCE|The statistical analysis was applied to arms Peginterferon/Ribavirin 800 mg (24 weeks) and Peginterferon/Ribavirin 800 mg (16 weeks).|Risk Difference (RD)|7.2|||||TWO_SIDED|95.0|-4.7|19.1||||||||19.1|-4.7|
72565581|NCT01258101|144662627|NON_INFERIORITY_OR_EQUIVALENCE|The statistical analysis was applied to arms Peginterferon/Ribavirin 800 mg (24 weeks) and Peginterferon/Ribavirin 400 mg (16 weeks).|Risk Difference (RD)|-21.1|||||TWO_SIDED|95.0|-42.2|-0.1||||||||-0.1|-42.2|
72565582|NCT01258101|144662629|NON_INFERIORITY_OR_EQUIVALENCE|The statistical analysis was applied to arms Peginterferon/Ribavirin 800 mg (16 weeks) and Peginterferon/Ribavirin 400 mg (16 weeks).|Risk Difference (RD)|-0.4|||||TWO_SIDED|95.0|-1.0|0.2||||||||0.2|-1.0|
72565583|NCT01258101|144662629|NON_INFERIORITY_OR_EQUIVALENCE|The statistical analysis was applied to arms Peginterferon/Ribavirin 800 mg (24 weeks) and Peginterferon/Ribavirin 400 mg (24 weeks).|Risk Difference (RD)|-2.6|||||TWO_SIDED|95.0|-6.4|1.3||||||||1.3|-6.4|
72565584|NCT01258101|144662629|NON_INFERIORITY_OR_EQUIVALENCE|The statistical analysis was applied to arms Peginterferon/Ribavirin 800 mg (24 weeks) and Peginterferon/Ribavirin 800 mg (16 weeks).|Risk Difference (RD)|0.0|||||TWO_SIDED|95.0|-1.4|1.4||||||||1.4|-1.4|
72565585|NCT01258101|144662629|NON_INFERIORITY_OR_EQUIVALENCE|The statistical analysis was applied to arms Peginterferon/Ribavirin 800 mg (24 weeks) and Peginterferon/Ribavirin 400 mg (16 weeks).|Risk Difference (RD)|0.6|||||TWO_SIDED|95.0|-0.5|1.7||||||||1.7|-0.5|
72622652|NCT03379870|144775401|SUPERIORITY|Analyzed Consonant Nucleus Consonant (CNC) Word scores obtained 12-months post-activation to evaluate differences between groups. Percent correct data were converted to rationalized arcsine units (RAU) prior to data analysis to control for potential floor or ceiling effects (e.g., scores \<20%).||||||0.768||||||The a priori threshold for statistical significance was \< 0.05.|Mixed Models Analysis|||||||.768
72470870|NCT04092452|144465191|SUPERIORITY||Risk Difference (RD)|0.2|STANDARD_ERROR_OF_MEAN|5.64|||TWO_SIDED|90.0|-9.1|9.5||||||Week 4||9.5|-9.1|
72565586|NCT01258101|144662637|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.629||||0.2667|TWO_SIDED||||||Regression, Cox|||||||0.2667
72565587|NCT01258101|144662637|SUPERIORITY_OR_OTHER|||||||0.9999|||||||Regression, Cox|||||||0.9999
72565588|NCT01258101|144662637|SUPERIORITY_OR_OTHER|||||||0.9891|||||||Regression, Cox|||||||0.9891
72565589|NCT01298778|144662650|SUPERIORITY_OR_OTHER|||||||0.05|||||||t-test, 2 sided|||acute pain scores with movement at 24 hours||||0.05
72565590|NCT02709486|144662681|SUPERIORITY|Step-down testing procedure within each of the primary outcome measures was applied to maintain Type I error. Tanezumab 5 mg versus placebo was tested first and if found significant, then the testing was continued for Tanezumab 2.5 mg versus placebo. Tanezumab treatment group was declared as superior to placebo if the corresponding treatment contrast was significant over all 3 primary outcome measures.|Least Square Mean Difference|-0.46|STANDARD_ERROR_OF_MEAN|0.18||0.0088|TWO_SIDED|95.0|-0.81|-0.12||Threshold for significance at 0.05 level.|ANCOVA|||Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. Analysis of covariance (ANCOVA) model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain subscale and baseline diary average pain as covariates, and study site as a random effect.||-0.12|-0.81|0.0088
72565591|NCT02709486|144662681|SUPERIORITY|A step-down testing procedure within each of the primary outcome measures was applied to maintain Type I error. Tanezumab 5 mg versus placebo was tested first and if found significant, then the testing was continued for Tanezumab 2.5 mg versus placebo. A tanezumab treatment group was declared as superior to placebo if the corresponding treatment contrast was significant over all 3 primary outcome measures.|Least Square Mean Difference|-0.62|STANDARD_ERROR_OF_MEAN|0.18||0.0006|TWO_SIDED|95.0|-0.97|-0.26||Threshold for significance at 0.05 level.|ANCOVA|||Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain subscale and baseline diary average pain as covariates, and study site as a random effect.||-0.26|-0.97|0.0006
72576669|NCT00094861|144680134|SUPERIORITY_OR_OTHER||Chi-Square Statistic|0.8553||||0.355||95.0||||Generalized Cochran-Mantel-Haenszel test for general association. Participants with no assessments were assumed as having grade ≥ 2 dysphagia in hypothesis testing.|Cochran-Mantel-Haenszel|Stratified by disease stage, ECOG performance status, and estimated weight loss in the 3 months before study randomization.||||||0.3550
72576670|NCT00094861|144680135|SUPERIORITY_OR_OTHER||Chi-Square Statistic|0.9936||||0.3189||95.0||||Generalized Cochran-Mantel-Haenszel test for mean score difference using modified ridit score.|Cochran-Mantel-Haenszel|Stratified by disease stage, ECOG performance status, and estimated weight loss in the 3 months before study randomization.||||||0.3189
72622653|NCT03379870|144775402|SUPERIORITY|Analyzed BKB-SIN scores obtained 12-months post-activation to evaluate differences between groups. Scores range from -6 to +21 and lower scores are better.||||||0.529||||||The a priori threshold for statistical significance was \< 0.05.|Mixed Models Analysis|||||||.529
72470871|NCT04092452|144465191|SUPERIORITY||Risk Difference (RD)|1.2|STANDARD_ERROR_OF_MEAN|5.25|||TWO_SIDED|90.0|-7.4|9.8||||||Week 4||9.8|-7.4|
72470872|NCT04092452|144465191|SUPERIORITY||Risk Difference (RD)|-4.0|STANDARD_ERROR_OF_MEAN|4.52|||TWO_SIDED|90.0|-11.4|3.4||||||Week 4||3.4|-11.4|
72470873|NCT04092452|144465191|SUPERIORITY||Risk Difference (RD)|4.3|STANDARD_ERROR_OF_MEAN|4.57|||TWO_SIDED|90.0|-3.3|11.8||||||Week 8||11.8|-3.3|
72470874|NCT04092452|144465191|SUPERIORITY||Risk Difference (RD)|6.2|STANDARD_ERROR_OF_MEAN|4.87|||TWO_SIDED|90.0|-1.8|14.2||||||Week 8||14.2|-1.8|
72622654|NCT03379870|144775403|SUPERIORITY|Analyzed SSQ scores obtained pre-operatively and at 12-months post-activation to evaluate benefit of cochlear implantation.||||||0.01||||||The a priori threshold for statistical significance was \< 0.05.|Mixed Models Analysis|||||||.010
72505315|NCT01645280|144541638|SUPERIORITY_OR_OTHER|||||||0.045|||||||ANCOVA|Treatment, screening CRP level (\>=1.50 mg/dL, \<1.50mg/dL) and baseline score as covariates.||||||0.045
72505316|NCT01645280|144541639|SUPERIORITY_OR_OTHER|||||||0.381|||||||Cochran-Mantel-Haenszel|Screening CRP level (\>= 1.50 mg/dL; \< 1.50 mg/dL) was used as stratification factors.||||||0.381
72505317|NCT01645280|144541639|SUPERIORITY_OR_OTHER|||||||0.543|||||||Cochran-Mantel-Haenszel|Screening CRP level (\>= 1.50 mg/dL; \< 1.50 mg/dL) was used as stratification factors.||||||0.543
72470875|NCT04092452|144465191|SUPERIORITY||Risk Difference (RD)|2.5|STANDARD_DEVIATION|4.42|||TWO_SIDED|90.0|-4.8|9.8||||||Week 8||9.8|-4.8|
72470876|NCT04092452|144465191|SUPERIORITY||Risk Difference (RD)|7.6|STANDARD_ERROR_OF_MEAN|5.43|||TWO_SIDED|90.0|-1.3|16.5||||||Week 12||16.5|-1.3|
72470877|NCT04092452|144465191|SUPERIORITY||Risk Difference (RD)|6.9|STANDARD_ERROR_OF_MEAN|5.4|||TWO_SIDED|90.0|-2.0|15.7||||||Week 12||15.7|-2.0|
72470878|NCT04092452|144465191|SUPERIORITY||Risk Difference (RD)|2.9|STANDARD_ERROR_OF_MEAN|5.09|||TWO_SIDED|90.0|-5.5|11.3||||||Week 12||11.3|-5.5|
72470879|NCT04092452|144465191|SUPERIORITY||Risk Difference (RD)|0.1|STANDARD_ERROR_OF_MEAN|3.88|||TWO_SIDED|90.0|-6.3|6.4||||||Week 16||6.4|-6.3|
72505318|NCT01645280|144541639|SUPERIORITY_OR_OTHER|||||||0.629|||||||Cochran-Mantel-Haenszel|Screening CRP level (\>= 1.50 mg/dL; \< 1.50 mg/dL) was used as stratification factors.||||||0.629
72505319|NCT01645280|144541639|SUPERIORITY_OR_OTHER|||||||0.273|||||||Cochran-Mantel-Haenszel|Screening CRP level (\>= 1.50 mg/dL; \< 1.50 mg/dL) was used as stratification factors.||||||0.273
72470880|NCT04092452|144465191|SUPERIORITY||Risk Difference (RD)|6.5|STANDARD_ERROR_OF_MEAN|5.63|||TWO_SIDED|90.0|-2.8|15.7||||||Week 16||15.7|-2.8|
72470881|NCT04092452|144465191|SUPERIORITY||Risk Difference (RD)|7.6|STANDARD_ERROR_OF_MEAN|5.64|||TWO_SIDED|90.0|-1.6|16.9||||||Week 16||16.9|-1.6|
72505320|NCT01645280|144541640|SUPERIORITY_OR_OTHER|||||||0.06|||||||ANCOVA|Treatment, screening CRP level (\>=1.50 mg/dL, \<1.50mg/dL) and baseline score as covariates.||||||0.060
72505321|NCT01645280|144541640|SUPERIORITY_OR_OTHER|||||||0.134|||||||ANCOVA|Treatment, screening CRP level (\>=1.50 mg/dL, \<1.50mg/dL) and baseline score as covariates.||||||0.134
72505322|NCT01645280|144541640|SUPERIORITY_OR_OTHER|||||||0.28|||||||ANCOVA|Treatment, screening CRP level (\>=1.50 mg/dL, \<1.50mg/dL) and baseline score as covariates.||||||0.280
72622655|NCT03379870|144775404|SUPERIORITY|Analyzed receptive language scores pre-operatively and 12-months post activation to test for change over time and differences between groups.|||||>|0.069||||||The a priori threshold for statistical significance was \< 0.05.|Mixed Models Analysis|||||||>.069
72395308|NCT01571427|144297239|EQUIVALENCE|Power calculation was based on the entire sample which combined CDR=0 and CDR=0.5 groups. Analyses by each CDR group are exploratory.|Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.62||0.94|TWO_SIDED||||||Regression, Linear||Estimates reported here is coefficient for the experimental group (with the control group as a reference), using a linear regression model controlling for Geriatric Depression Scale - 15 items version (GDS-15).|Analysis 3: CDR 0.5 (n=34)||||0.94
72470882|NCT02127125|144465193|SUPERIORITY||||||<|0.025||||||p-value not adjusted for multiple comparison, a priori threshold for significance set at p\<0.025 for multiple comparisons.|Generalized Estimating Equation|||Null hypothesis is that Sevelamer treated Obese subjects with normal glucose tolerance will show no post-treatment change in insulin sensitivity compared to placebo treated subjects.||||<0.025
72470883|NCT02127125|144465193|SUPERIORITY||||||>|0.05||||||p-value not adjusted for multiple comparison, a priori threshold for significance set at p\<0.025 for multiple comparisons.|Generalized Estimating Equation|||Null hypothesis is that Synbiotic treated Obese subjects with normal glucose tolerance will show no post-treatment change in insulin sensitivity compared to placebo treated subjects.||||>0.05
72470884|NCT02127125|144465194|SUPERIORITY||||||>|0.05||||||p-value not adjusted for multiple comparison, a priori threshold for significance set at p\<0.025 for multiple comparisons.|Generalized Estimating Equation|||Null hypothesis is that Sevelamer treated Obese subjects with normal glucose tolerance will show no post-treatment change in insulin sensitivity compared to placebo treated subjects.||||>0.05
72470885|NCT02127125|144465194|SUPERIORITY||||||>|0.05||||||p-value not adjusted for multiple comparison, a priori threshold for significance set at p\<0.025 for multiple comparisons.|Generalized Estimating Equation|||Null hypothesis is that Synbiotic treated Obese subjects with normal glucose tolerance will show no post-treatment change in insulin sensitivity compared to placebo treated subjects.||||>0.05
72505323|NCT01645280|144541640|SUPERIORITY_OR_OTHER|||||||0.345|||||||ANCOVA|Treatment, screening CRP level (\>=1.50 mg/dL, \<1.50mg/dL) and baseline score as covariates.||||||0.345
72505324|NCT00234104|144541644|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.09||||0.0074||95.0|||||t-test, 2 sided|Dunnett's test was used||||||0.0074
72505325|NCT00234104|144541644|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.82||||0.0459||95.0|||||t-test, 2 sided|Dunnett's test was used||||||0.0459
72505326|NCT00234104|144541644|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.32||||0.001||95.0|||||t-test, 2 sided|Dunnett's test was used||||||0.0010
72505327|NCT02052960|144541690|SUPERIORITY||Hazard Ratio (HR)|1.0||||0.86|TWO_SIDED|95.0|0.736|1.359|||Log Rank|||||1.359|0.736|0.86
72505328|NCT02052960|144541691|SUPERIORITY||Mean Difference (Net)|-1.9||||0.77|TWO_SIDED|95.0|-14.5|10.7|||Chi-squared|||||10.7|-14.5|0.77
72505329|NCT02052960|144541692|SUPERIORITY||Mean Difference (Net)|-1.21||||0.83|TWO_SIDED|95.0|-12.05|9.63|||Chi-squared|||||9.63|-12.05|0.83
72505330|NCT02052960|144541693|SUPERIORITY||Hazard Ratio (HR)|1.057||||0.7|TWO_SIDED|95.0|0.814|1.372|||Log Rank|||||1.372|0.814|0.70
72505331|NCT02052960|144541694|SUPERIORITY||Hazard Ratio (HR)|1.012||||0.96|TWO_SIDED|95.0|0.734|1.396|||Log Rank|||||1.396|0.734|0.96
72505332|NCT03849560|144541696|NON_INFERIORITY|Odds ratio was calculated to compare seroconversion for antigen H1N1 in group Grippol® Quadri and groups Grippol® Plus, trivalent (Yamagata lineage)+Grippol® Plus, trivalent (Victoria lineage)|Odds Ratio, log|1.22|||||TWO_SIDED|95.0|0.82|1.82||||||||1.82|0.82|
72505333|NCT03849560|144541696|NON_INFERIORITY|Odds ratio was calculated to compare seroconversion for antigen H3N2 in group Grippol® Quadri and groups Grippol® Plus, trivalent (Yamagata lineage)+Grippol® Plus, trivalent (Victoria lineage)|Odds Ratio, log|1.54|||||TWO_SIDED|95.0|1.08|2.3||||||||2.30|1.08|
72505334|NCT03849560|144541696|NON_INFERIORITY|Odds ratio was calculated to compare seroconversion for YAMA antigen in group Grippol® Quadri and group Grippol® Plus, trivalent (Yamagata lineage)|Odds Ratio, log|1.39|||||TWO_SIDED|95.0|0.9|2.15||||||||2.15|0.90|
72395309|NCT01571427|144297240|EQUIVALENCE|It was calculated that 82 participants randomized in a 1:1 fashion between the 2 arms would have at least 80% to detect a Cohen's D of 0.45 in the difference in changes from baseline to week 6 at alpha=0.05 (two tailed). All randomized participants (n=83) were included in the analysis.|Mean Difference (Final Values)|-2.11|STANDARD_ERROR_OF_MEAN|2.84||0.46|TWO_SIDED||||||Regression, Linear||Estimates reported here is coefficient for the experimental group (with the control group as a reference), using a linear regression model controlling for Geriatric Depression Scale - 15 items version (GDS-15).|||||0.46
72395310|NCT01571427|144297240|EQUIVALENCE|Power calculation was based on the entire sample which combined CDR=0 and CDR=0.5 groups. Analyses by each CDR group are exploratory.|Mean Difference (Final Values)|-1.07|STANDARD_ERROR_OF_MEAN|2.08||0.61|TWO_SIDED||||||Regression, Linear||Estimates reported here is coefficient for the experimental group (with the control group as a reference), using a linear regression model controlling for Geriatric Depression Scale - 15 items version (GDS-15).|Analysis 2: CDR 0 (n=49)||||0.61
72395311|NCT01571427|144297240|EQUIVALENCE|Power calculation was based on the entire sample which combined CDR=0 and CDR=0.5 groups. Analyses by each CDR group are exploratory.|Mean Difference (Final Values)|-1.66|STANDARD_ERROR_OF_MEAN|6.42||0.8|TWO_SIDED||||||Regression, Linear||Estimates reported here is coefficient for the experimental group (with the control group as a reference), using a linear regression model controlling for Geriatric Depression Scale - 15 items version (GDS-15).|Analysis 3: CDR 0.5 (n=34)||||0.80
72395312|NCT01571427|144297241|EQUIVALENCE|It was calculated that 82 participants randomized in a 1:1 fashion between the 2 arms would have at least 80% to detect a Cohen's D of 0.45 in the difference in changes from baseline to week 6 at alpha=0.05 (two tailed). All randomized participants (n=83) were included in the analysis.|Mean Difference (Final Values)|3.25|STANDARD_ERROR_OF_MEAN|8.88||0.72|TWO_SIDED||||||Regression, Linear||Estimates reported here is coefficient for the experimental group (with the control group as a reference), using a linear regression model controlling for Geriatric Depression Scale - 15 items version (GDS-15).|||||0.72
72395313|NCT01571427|144297241|EQUIVALENCE|Power calculation was based on the entire sample which combined CDR=0 and CDR=0.5 groups. Analyses by each CDR group are exploratory.|Mean Difference (Final Values)|2.26|STANDARD_ERROR_OF_MEAN|11.1||0.84|TWO_SIDED||||||Regression, Linear||Estimates reported here is coefficient for the experimental group (with the control group as a reference), using a linear regression model controlling for Geriatric Depression Scale - 15 items version (GDS-15).|Analysis 2: CDR 0 (n=49)||||0.84
72395314|NCT01571427|144297241|EQUIVALENCE|Power calculation was based on the entire sample which combined CDR=0 and CDR=0.5 groups. Analyses by each CDR group are exploratory.|Mean Difference (Final Values)|12.39|STANDARD_ERROR_OF_MEAN|14.4||0.4|TWO_SIDED||||||Regression, Linear||Estimates reported here is coefficient for the experimental group (with the control group as a reference), using a linear regression model controlling for Geriatric Depression Scale - 15 items version (GDS-15).|Analysis 3: CDR 0.5 (n=34)||||0.40
72395315|NCT01571427|144297242|EQUIVALENCE|It was calculated that 82 participants randomized in a 1:1 fashion between the 2 arms would have at least 80% to detect a Cohen's D of 0.45 in the difference in changes from baseline to week 6 at alpha=0.05 (two tailed). All randomized participants (n=83) were included in the analysis.|Mean Difference (Final Values)|-0.81|STANDARD_ERROR_OF_MEAN|0.91||0.38|TWO_SIDED||||||Regression, Linear||Estimates reported here is coefficient for the experimental group (with the control group as a reference), using a linear regression model controlling for Geriatric Depression Scale - 15 items version (GDS-15).|||||0.38
72395316|NCT01571427|144297242|EQUIVALENCE|Power calculation was based on the entire sample which combined CDR=0 and CDR=0.5 groups. Analyses by each CDR group are exploratory.|Mean Difference (Final Values)|-1.12|STANDARD_ERROR_OF_MEAN|1.31||0.39|TWO_SIDED||||||Regression, Linear||Estimates reported here is coefficient for the experimental group (with the control group as a reference), using a linear regression model controlling for Geriatric Depression Scale - 15 items version (GDS-15).|Analysis 2: CDR 0 (n=49)||||0.39
72565592|NCT02709486|144662682|SUPERIORITY|Step-down testing procedure within each of the primary outcome measures was applied to maintain Type I error. Tanezumab 5 mg versus placebo was tested first and if found significant, then the testing was continued for Tanezumab 2.5 mg versus placebo. Tanezumab treatment group was declared as superior to placebo if the corresponding treatment contrast was significant over all 3 primary outcome measures.|Least Square Mean Difference|-0.59|STANDARD_ERROR_OF_MEAN|0.18||0.0008|TWO_SIDED|95.0|-0.93|-0.24||Threshold for significance at 0.05 level.|ANCOVA|||Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariates, and study site as a random effect.||-0.24|-0.93|0.0008
72565593|NCT02709486|144662682|SUPERIORITY|Step-down testing procedure within each of the primary outcome measures was applied to maintain Type I error. Tanezumab 5 mg versus placebo was tested first and if found significant, then the testing was continued for Tanezumab 2.5 mg versus placebo. Tanezumab treatment group was declared as superior to placebo if the corresponding treatment contrast was significant over all 3 primary outcome measures.|Least Square Mean Difference|-0.71|STANDARD_ERROR_OF_MEAN|0.17|<|0.0001|TWO_SIDED|95.0|-1.05|-0.36||Threshold for significance at 0.05 level.|ANCOVA|||Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariates, and study site as a random effect.||-0.36|-1.05|<.0001
72565594|NCT02709486|144662683|SUPERIORITY|A step-down testing procedure within each of the primary outcome measures was applied to maintain Type I error. Tanezumab 5 mg versus placebo was tested first and if found significant, then the testing was continued for Tanezumab 2.5 mg versus placebo. A tanezumab treatment group was declared as superior to placebo if the corresponding treatment contrast was significant over all 3 primary outcome measures.|Least Square Mean Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.07||0.1092|TWO_SIDED|95.0|-0.24|0.02||Threshold for significance at 0.05 level.|ANCOVA|||Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline PGA of osteoarthritis and baseline diary average pain as covariates, and study site as a random effect.||0.02|-0.24|0.1092
72505335|NCT03849560|144541696|NON_INFERIORITY|Odds ratio was calculated to compare seroconversion for VICT antigen in group Grippol® Quadri and group Grippol® Plus, trivalent (Victoria lineage)|Odds Ratio, log|1.05|||||TWO_SIDED|95.0|0.68|1.63||||||||1.63|0.68|
72505336|NCT03849560|144541697|NON_INFERIORITY|The Grippol® Quadri vaccine considered non-inferior to Grippol® Plus, trivalent (Yamagata lineage) and Grippol® Plus, trivalent (Victoria lineage) vaccines for the strain A/H1N1 if the upper limit of the two-sided 95% Confidence Interval (CI) of the ratio of means of geometric antibody titers for H1N1 was ≤1.5|Mean Difference (Final Values)|0.8933|||||TWO_SIDED|95.0|0.7762|1.03||||||Non-inferiority of Grippol® Quadri over Grippol® Plus, trivalent (Yamagata lineage) and Grippol® Plus, trivalent (Victoria lineage) for the strain A/H1N1||1.030|0.7762|
72395317|NCT01571427|144297242|EQUIVALENCE|Power calculation was based on the entire sample which combined CDR=0 and CDR=0.5 groups. Analyses by each CDR group are exploratory.|Mean Difference (Final Values)|-0.68|STANDARD_ERROR_OF_MEAN|1.26||0.59|TWO_SIDED||||||Regression, Linear||Estimates reported here is coefficient for the experimental group (with the control group as a reference), using a linear regression model controlling for Geriatric Depression Scale - 15 items version (GDS-15).|Analysis 3: CDR 0.5 (n=34)||||0.59
72505337|NCT03849560|144541697|NON_INFERIORITY|The Grippol® Quadri vaccine considered non-inferior to Grippol® Plus, trivalent (Yamagata lineage) and Grippol® Plus, trivalent (Victoria lineage) vaccines for the strain A/H3N2 if the upper limit of the two-sided 95% CI of the ratio of means of geometric antibody titers for H3N2 was ≤1.5|Median Difference (Final Values)|0.8913|||||TWO_SIDED|95.0|0.7516|1.0593||||||Non-inferiority of Grippol® Quadri over Grippol® Plus, trivalent (Yamagata lineage) and Grippol® Plus, trivalent (Victoria lineage) for the strain A/H3N2||1.0593|0.7516|
72505338|NCT03849560|144541697|NON_INFERIORITY|The Grippol® Quadri vaccine considered non-inferior to Grippol® Plus, trivalent (Yamagata lineage) vaccine for the strain B/Yamagata if the upper limit of the two-sided 95% CI of the ratio of means of geometric antibody titers for Yamagata antigen was ≤1|Mean Difference (Final Values)|0.8185|||||TWO_SIDED|95.0|0.6918|0.9683||||||Non-inferiority of Grippol® Quadri over Grippol® Plus, trivalent (Yamagata lineage) for the strain B/Yamagata||0.9683|0.6918|
72505339|NCT03849560|144541697|NON_INFERIORITY|The Grippol® Quadri vaccine considered non-inferior to Grippol® Plus, trivalent (Victoria lineage) vaccine for the strain B/Victoria if the upper limit of the two-sided 95% CI of the ratio of means of geometric antibody titers for Victoria antigen was ≤1|Mean Difference (Final Values)|1.0328||||0.05|TWO_SIDED|95.0|0.857|1.2445|||ANCOVA|||Non-inferiority of Grippol® Quadri over Grippol® Plus, trivalent (Victoria lineage) for the strain B/Victoria||1.2445|0.8570|0.05
72505340|NCT03849560|144541698|NON_INFERIORITY|Seroprotection for strain A/H1N1 in Grippol® Quadri group in comparison to Grippol® Plus, trivalent (Yamagata lineage)+Grippol® Plus, trivalent (Victoria lineage) groups||||||0.758|||||||Fisher Exact|||||||0.758
72505341|NCT03849560|144541698|NON_INFERIORITY|Seroprotection for strain A/H3N2 in Grippol® Quadri group in comparison to Grippol® Plus, trivalent (Yamagata lineage)+Grippol® Plus, trivalent (Victoria lineage) groups||||||0.282|||||||Fisher Exact|||||||0.282
72505342|NCT03849560|144541698|NON_INFERIORITY|Seroprotection for strain B/Yamagata in Grippol® Quadri group in comparison to Grippol® Plus, trivalent (Yamagata lineage) group||||||0.352|||||||Fisher Exact|||||||0.352
72505343|NCT03849560|144541698|NON_INFERIORITY|Seroprotection for strain B/Victoria in Grippol® Quadri group in comparison to Grippol® Plus, trivalent (Victoria lineage) group||||||0.815|||||||Fisher Exact|||||||0.815
72505344|NCT03849560|144541699|OTHER|||||||0.452|||||||Log Rank|||||||0.452
72505345|NCT03849560|144541699|OTHER|||||||0.639|||||||Log Rank|||||||0.639
72395318|NCT01571427|144297243|EQUIVALENCE|It was calculated that 82 participants randomized in a 1:1 fashion between the 2 arms would have at least 80% to detect a Cohen's D of 0.45 in the difference in changes from baseline to week 6 at alpha=0.05 (two tailed). All randomized participants (n=83) were included in the analysis.|Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.02||0.03|TWO_SIDED||||||Regression, Linear||Estimates reported here is coefficient for the experimental group (with the control group as a reference), using a linear regression model controlling for Geriatric Depression Scale - 15 items version (GDS-15).|||||0.03
72505346|NCT03849560|144541701|OTHER|The lower limit of the two-sided 95% CI (log 10) on coefficient of increase of mean geometric antibody titer for H1N1 should be ˃ 2.5|Coefficient of increase of mean geometri|4.86|||||TWO_SIDED|95.0|4.22|5.6||||||Coefficient of increase of mean geometric antibody titer for H1N1 in Grippol® Quadri group||5.60|4.22|
72505347|NCT03849560|144541701|OTHER|The lower limit of the two-sided 95% CI (log 10) on coefficient of increase of mean geometric antibody titer for H3N2 should be ˃ 2.5|Coefficient of increase of GMT|5.32|||||TWO_SIDED|95.0|4.53|6.24||||||Coefficient of increase of mean geometric antibody titer for H3N2 in Grippol® Quadri group||6.24|4.53|
72505348|NCT03849560|144541701|OTHER|The lower limit of the two-sided 95% CI (log 10) on coefficient of increase of mean geometric antibody titer for Yamagata should be ˃ 2.5|Coefficient of increase of GMT|5.47|||||TWO_SIDED|95.0|4.78|6.25||||||Coefficient of increase of mean geometric antibody titer for Yamagata in Grippol® Quadri group||6.25|4.78|
72505349|NCT03849560|144541701|OTHER|The lower limit of the two-sided 95% CI (log 10) on coefficient of increase of mean geometric antibody titer for Victoria should be ˃ 2.5|Coefficient of increase of GMT|4.77|||||TWO_SIDED|95.0|4.14|5.49||||||Coefficient of increase of mean geometric antibody titer for Victoria in Grippol® Quadri group||5.49|4.14|
72505350|NCT03849560|144541701|OTHER|The lower limit of the two-sided 95% CI (log 10) on coefficient of increase of mean geometric antibody titer for H1N1 should be ˃ 2.5|Coefficient of increase of GMT|4.21|||||TWO_SIDED|95.0|3.59|4.94||||||Coefficient of increase of mean geometric antibody titer for H1N1 in Grippol® Plus, trivalent (Yamagata lineage) group||4.94|3.59|
72505351|NCT03849560|144541701|OTHER|The lower limit of the two-sided 95% CI (log 10) on coefficient of increase of mean geometric antibody titer for H3N2 should be ˃ 2.5|Coefficient of increase of GMT|5.22|||||TWO_SIDED|95.0|4.45|6.12||||||Coefficient of increase of mean geometric antibody titer for H3N2 in Grippol® Plus, trivalent (Yamagata lineage) group||6.12|4.45|
72505352|NCT03849560|144541701|OTHER|The lower limit of the two-sided 95% CI (log 10) on coefficient of increase of mean geometric antibody titer for Yamagata should be ˃ 2.5|Coefficient of increase of GMT|4.04|||||TWO_SIDED|95.0|3.48|4.69||||||Coefficient of increase of mean geometric antibody titer for Yamagata in Grippol® Plus, trivalent (Yamagata lineage) group||4.69|3.48|
72622656|NCT03379870|144775405|SUPERIORITY|Analyzed articulation scores pre-operative and 12-months post activation to test for change over time and differences between groups.||||||0.02||||||The a priori threshold for statistical significance was \< 0.05.|Mixed Models Analysis|Main effect of test point (pre-operative vs post-activation)||||||.02
72622657|NCT03379870|144775406|SUPERIORITY|Analyzed expressive language scores pre-operatively and 12-months post activation to test for change over time and differences between groups.||||||0.007||||||The a priori threshold for statistical significance was \< 0.05.|Mixed Models Analysis|Main effect of test point (pre-operative vs post activation)||||||.007
72622658|NCT01557569|144775440|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.413|||<|0.05|TWO_SIDED||||||Kruskal-Wallis|||Due to skewed data, Kruskal Wallis Test was used.||||<0.05
72622659|NCT02943499|144775441|SUPERIORITY|||||||0.92|||||||t-test, 2 sided|||To examine between-group differences in pre- vs. post-treatment cue reactivity, the post-treatment PCC BOLD response for the smoking vs neutral contrast was subtracted from the baseline response. The groups were then compared directly on this measure using a t-test.||||0.92
72622660|NCT00557440|144775451|SUPERIORITY_OR_OTHER||LS Mean Difference|0.165|STANDARD_ERROR_OF_MEAN|0.0492||0.001|TWO_SIDED|95.0|0.066|0.263||Statistical significance (two-sided) at 5% level. p-values were not corrected for multiplicity.|ANCOVA|Treatment, period, sequence and center as fixed effects, period baseline FEV1 as a covariate, and patient nested within sequence as a random effect.||||0.263|0.066|0.001
72622661|NCT03524157|144775456|NON_INFERIORITY|it will be considered non-inferior if there are no differences greater than 20%.||||||0.273|||||||Kruskal-Wallis|||||||0.273
72395319|NCT01571427|144297243|EQUIVALENCE|Power calculation was based on the entire sample which combined CDR=0 and CDR=0.5 groups. Analyses by each CDR group are exploratory.|Mean Difference (Final Values)|-0.03|STANDARD_ERROR_OF_MEAN|0.03||0.24|TWO_SIDED||||||Regression, Linear||Estimates reported here is coefficient for the experimental group (with the control group as a reference), using a linear regression model controlling for Geriatric Depression Scale - 15 items version (GDS-15).|Analysis 2: CDR 0 (n=49)||||0.24
72395320|NCT01571427|144297243|EQUIVALENCE|Power calculation was based on the entire sample which combined CDR=0 and CDR=0.5 groups. Analyses by each CDR group are exploratory.|Mean Difference (Final Values)|-0.09|STANDARD_ERROR_OF_MEAN|0.04||0.04|TWO_SIDED||||||Regression, Linear||Estimates reported here is coefficient for the experimental group (with the control group as a reference), using a linear regression model controlling for Geriatric Depression Scale - 15 items version (GDS-15).|Analysis 3: CDR 0.5 (n=34)||||0.04
72395321|NCT01571427|144297244|EQUIVALENCE|It was calculated that 82 participants randomized in a 1:1 fashion between the 2 arms would have at least 80% to detect a Cohen's D of 0.45 in the difference in changes from baseline to week 6 at alpha=0.05 (two tailed). All randomized participants (n=83) were included in the analysis.|Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.05||0.65|TWO_SIDED||||||Regression, Linear||Estimates reported here is coefficient for the experimental group (with the control group as a reference), using a linear regression model controlling for Geriatric Depression Scale - 15 items version (GDS-15).|||||0.65
72395322|NCT01571427|144297244|EQUIVALENCE|Power calculation was based on the entire sample which combined CDR=0 and CDR=0.5 groups. Analyses by each CDR group are exploratory.|Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.05||0.64|TWO_SIDED||||||Regression, Linear||Estimates reported here is coefficient for the experimental group (with the control group as a reference), using a linear regression model controlling for Geriatric Depression Scale - 15 items version (GDS-15).|Analysis 2: CDR 0 (n=49)||||0.64
72395323|NCT01571427|144297244|EQUIVALENCE|Power calculation was based on the entire sample which combined CDR=0 and CDR=0.5 groups. Analyses by each CDR group are exploratory.|Mean Difference (Final Values)|-0.08|STANDARD_ERROR_OF_MEAN|0.1||0.42|TWO_SIDED||||||Regression, Linear||Estimates reported here is coefficient for the experimental group (with the control group as a reference), using a linear regression model controlling for Geriatric Depression Scale - 15 items version (GDS-15).|Analysis 3: CDR 0.5 (n=34)||||0.42
72622662|NCT03524157|144775457|NON_INFERIORITY|it will be considered non-inferiority if there are no differences greater than 20%||||||0.788|||||||Kruskal-Wallis|||||||0.788
72622663|NCT03524157|144775459|NON_INFERIORITY|it will be considered non-inferiority if there are no differences greater than 20%|||||>|0.05|||||||Chi-squared, Corrected|||||||>0.05
72622664|NCT03524157|144775460|NON_INFERIORITY|it will be considered non-inferiority if there are no differences greater than 20%||||||0.008|||||||Kruskal-Wallis|||||||0.008
72622665|NCT03524157|144775461|NON_INFERIORITY|it will be considered non-inferiority if there are no differences greater than 20%|||||>|0.05|||||||Chi-squared, Corrected|||||||>0.05
72622666|NCT03524157|144775463|NON_INFERIORITY|it will be considered non-inferiority if there are no differences greater than 20%|||||>|0.05|||||||Chi-squared, Corrected|||||||>0.05
72622667|NCT03524157|144775464|NON_INFERIORITY|it will be considered non-inferiority if there are no differences greater than 20%|||||>|0.05|||||||Chi-squared, Corrected|||||||>0.05
72622668|NCT03524157|144775465|NON_INFERIORITY|it will be considered non-inferiority if there are no differences greater than 20%|||||>|0.05|||||||Chi-squared|||||||>0.05
72622669|NCT01592747|144775466|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.1||||0.659|TWO_SIDED|95.0|0.7|1.8|||Cochran-Mantel-Haenszel|||Cochran-Mantel-Haenszel test was performed controlling for Autism Spectrum Disorder (ASD) subtype. Odds ratio was calculated for placebo vs. memantine full dose.||1.8|0.7|0.6590
72622670|NCT01592747|144775466|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.1||||0.7839|TWO_SIDED|95.0|0.7|1.7|||Cochran-Mantel-Haenszel|||Cochran-Mantel-Haenszel test was performed controlling for Autism Spectrum Disorder (ASD) subtype. Odds ratio was calculated for placebo vs. Memantine reduced dose||1.7|0.7|0.7839
72622671|NCT01592747|144775468|SUPERIORITY_OR_OTHER||Least squares mean difference|0.1||||0.8136|TWO_SIDED|95.0|-0.5|0.7|||ANCOVA|||||0.7|-0.5|0.8136
72622672|NCT01592747|144775468|SUPERIORITY_OR_OTHER||Least squares mean difference|0.0||||0.9244|TWO_SIDED|95.0|-0.6|0.5|||ANCOVA|||||0.5|-0.6|0.9244
72622673|NCT01592747|144775469|SUPERIORITY_OR_OTHER||Least squares mean difference|0.1||||0.7611|TWO_SIDED|95.0|-0.5|0.7|||ANCOVA|||||0.7|-0.5|0.7611
72622674|NCT01592747|144775469|SUPERIORITY_OR_OTHER||Least squares mean difference|0.3||||0.3176|TWO_SIDED|95.0|-0.3|0.9|||ANCOVA|||||0.9|-0.3|0.3176
72622675|NCT01592747|144775470|SUPERIORITY_OR_OTHER||Least squares mean difference|0.0||||0.902|TWO_SIDED|95.0|-0.5|0.6|||ANCOVA|||||0.6|-0.5|0.9020
72622676|NCT01592747|144775470|SUPERIORITY_OR_OTHER||Least squares mean difference|0.4||||0.1279|TWO_SIDED|95.0|-0.1|1.0|||ANCOVA|||||1.0|-0.1|0.1279
72576671|NCT00094861|144680136|SUPERIORITY_OR_OTHER||Chi-Square Statistic|0.437||||0.5086||95.0||||Generalized Cochran-Mantel-Haenszel test for general association. Participants with no assessments were assumed as having grade 5 dysphagia in hypothesis testing.|Cochran-Mantel-Haenszel|Stratified by disease stage, ECOG performance status, and estimated weight loss in the 3 months before study randomization.||||||0.5086
72470886|NCT02127125|144465195|SUPERIORITY||||||>|0.05||||||p-value not adjusted for multiple comparison, a priori threshold for significance set at p\<0.025 for multiple comparisons.|Generalized Estimating Equation|||Null hypothesis is that Sevelamer treated Obese subjects with normal glucose tolerance will show no post-treatment change in Lactulose:Mannitol ratio compared to placebo treated subjects.||||>0.05
72470887|NCT02127125|144465195|SUPERIORITY||||||>|0.05||||||p-value not adjusted for multiple comparison, a priori threshold for significance set at p\<0.025 for multiple comparisons.|Generalized Estimating Equation|||Null hypothesis is that Synbiotic treated Obese subjects with normal glucose tolerance will show no post-treatment change in Lactulose:Mannitol ratio compared to placebo treated subjects.||||>0.05
72470888|NCT00855413|144465230|OTHER|one sided ANOVA.|Mean Difference (Final Values)|4.23|STANDARD_DEVIATION|0.15||0.03|TWO_SIDED|||||The degrees of freedom (df) for the within factor (number of visits - 1) was 2, and the second df is the error df of 17.|ANOVA|||An overall summary score of neurocognitive functioning was created by averaging all tests. Best available demographically corrected normative data were utilized to create z scores and then deficit scores for impairment ratings.Change in neurocognitive functioning was analyzed using a one sided repeated measures ANOVA with neurocognitive performance as the dependent variable (total z score) and time (visit) as the independent variable. Degrees of freedom were 2,17.||||0.03
72470889|NCT00855413|144465232|OTHER|Spearman correlation|spearman correlation|-0.82|||<|0.005|TWO_SIDED|||||R = -0.82|Spearman correlation|||Correlation between time (days) to HIV RNA suppression \<200 copies/mL and total z score (mean) was assessed by Spearman correlation|Correlation between time (days) to HIV RNA suppression \<200 copies/mL and total z score (mean) was assessed by Spearman correlation|||<.005
72505353|NCT03849560|144541701|OTHER|The lower limit of the two-sided 95% CI (log 10) on coefficient of increase of mean geometric antibody titer for H1N1 should be ˃ 2.5|Coefficient of increase of GMT|4.6|||||TWO_SIDED|95.0|3.97|5.34||||||Coefficient of increase of mean geometric antibody titer for H1N1 in Grippol® Plus, trivalent (Victoria lineage) group||5.34|3.97|
72505354|NCT03849560|144541701|OTHER|The lower limit of the two-sided 95% CI (log 10) on coefficient of increase of mean geometric antibody titer for H3N2 should be ˃ 2.5|Coefficient of increase of GMT|5.17|||||TWO_SIDED|95.0|4.38|6.12||||||Coefficient of increase of mean geometric antibody titer for H3N2 in Grippol® Plus, trivalent (Victoria lineage) group||6.12|4.38|
72505355|NCT03849560|144541701|OTHER|The lower limit of the two-sided 95% CI (log 10) on coefficient of increase of mean geometric antibody titer for Victoria should be ˃ 2.5|Coefficient of increase of GMT|4.72|||||TWO_SIDED|95.0|4.0|5.56||||||Coefficient of increase of mean geometric antibody titer for Victoria in Grippol® Plus, trivalent (Victoria lineage) group||5.56|4.00|
72505356|NCT01678846|144541761|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.4|||<|0.0001|TWO_SIDED|95.0|0.26|0.64|||Regression, Logistic||An odds ratio of less than 1 would demonstrate a protective effect of the intervention. Unadjusted odds ratio presented, accounting for correlation between students within schools.|Does the Toolkit intervention reduce physical violence from school staff to Ugandan primary school students.||0.64|0.26|<0.0001
72505357|NCT00553787|144541780|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.6|STANDARD_ERROR_OF_MEAN|0.328|<|0.0001|TWO_SIDED|95.0|7.96|9.25||Intersection-union method applied in a step-down testing approach|ANCOVA|||With at least 500 subjects in each of the 3 arms in this trial, the trial has more than 90% power to detect a difference of at least 3.1% between combination and placebo treatment assuming a standard deviation of 5.3% and a significance level of 0.05.||9.25|7.96|<0.0001
72505358|NCT00553787|144541780|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.58|STANDARD_ERROR_OF_MEAN|0.403|<|0.0001|TWO_SIDED|95.0|5.79|7.37||Intersection-union method applied in a step-down testing approach|ANCOVA|||With at least 500 subjects in each of the 3 arms in this trial, the trial has more than 90% power to detect a difference of at least 3.1% between combination and placebo treatment assuming a standard deviation of 5.3% and a significance level of 0.05.||7.37|5.79|<0.0001
72505359|NCT00553787|144541780|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.03|STANDARD_ERROR_OF_MEAN|0.402|<|0.0001|TWO_SIDED|95.0|1.24|2.82||Intersection-union method applied in a step-down testing approach|ANCOVA|||With at least 500 subjects in each of the 3 arms in this trial, the trial has more than 90% power to detect a difference of at least 3.1% between combination and placebo treatment assuming a standard deviation of 5.3% and a significance level of 0.05.||2.82|1.24|<0.0001
72505360|NCT00553787|144541781|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|9.03|STANDARD_ERROR_OF_MEAN|0.955|<|0.0001|TWO_SIDED|95.0|7.34|11.11||Intersection-union method applied in a step-down testing approach|Regression, Logistic|||With at least 500 subjects in each of the 3 arms in this trial, the trial has more than 90% power to detect a difference of at least 3.1% between combination and placebo treatment assuming a standard deviation of 5.3% and a significance level of 0.05.||11.11|7.34|<0.0001
72622677|NCT01592747|144775471|SUPERIORITY_OR_OTHER||Least squares mean difference|0.3||||0.4144|TWO_SIDED|95.0|-0.4|1.1|||ANCOVA|||||1.1|-0.4|0.4144
72576672|NCT00094861|144680137|SUPERIORITY_OR_OTHER||Chi-Square Statistic|0.46||||0.4976||95.0||||Generalized Cochran-Mantel-Haenszel test for general association. Participants with no assessments were assumed as having grade ≥ 3 dysphagia in hypothesis testing.|Cochran-Mantel-Haenszel|Stratified by disease stage, ECOG performance status, and estimated weight loss in the 3 months before study randomization.||||||0.4976
72505361|NCT00553787|144541781|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.27|STANDARD_ERROR_OF_MEAN|0.768|<|0.0001|TWO_SIDED|95.0|4.93|7.97||Intersection-union method applied in a step-down testing approach|Regression, Logistic|||With at least 500 subjects in each of the 3 arms in this trial, the trial has more than 90% power to detect a difference of at least 3.1% between combination and placebo treatment assuming a standard deviation of 5.3% and a significance level of 0.05.||7.97|4.93|<0.0001
72622678|NCT01592747|144775471|SUPERIORITY_OR_OTHER||Least squares mean difference|0.3||||0.4212|TWO_SIDED|95.0|-0.4|1.0|||ANCOVA|||||1.0|-0.4|0.4212
72622679|NCT01592747|144775472|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.2||||0.6238|TWO_SIDED|95.0|-0.9|0.5|||ANCOVA|||||0.5|-0.9|0.6238
72622680|NCT01592747|144775472|SUPERIORITY_OR_OTHER||Least squares mean difference|0.2||||0.5957|TWO_SIDED|95.0|-0.5|0.9|||ANCOVA|||||0.9|-0.5|0.5957
72622681|NCT01592747|144775473|SUPERIORITY_OR_OTHER||Least squares mean difference|0.1||||0.864|TWO_SIDED|95.0|-0.6|0.7|||ANCOVA|||||0.7|-0.6|0.8640
72395324|NCT01571427|144297245|EQUIVALENCE|It was calculated that 82 participants randomized in a 1:1 fashion between the 2 arms would have at least 80% to detect a Cohen's D of 0.45 in the difference in changes from baseline to week 6 at alpha=0.05 (two tailed). All randomized participants (n=83) were included in the analysis.|Mean Difference (Final Values)|-0.03|STANDARD_ERROR_OF_MEAN|0.45||0.45|TWO_SIDED||||||Regression, Linear||Estimates reported here is coefficient for the experimental group (with the control group as a reference), using a linear regression model controlling for Geriatric Depression Scale - 15 items version (GDS-15).|||||0.45
72470890|NCT00848484|144465243|SUPERIORITY_OR_OTHER|||||||0.277||95.0|||||constrained Longitudinal Data Analysis|The repeated measures model included the terms site and sequence \* time with a restriction of the same baseline mean across treatment sequences.||||||0.277
72470891|NCT00848484|144465244|SUPERIORITY_OR_OTHER|||||||0.686||95.0||||The Benjamini \& Hochberg False Discovery Rate (FDR) approach at critical value 0.1 was used to adjust p-Values among five secondary cognition endpoints.|constrained Longitudinal Data Analysis|The repeated measures model included the terms site and sequence \* time with a restriction of the same baseline mean across treatment sequences.||||||0.686
72470892|NCT00848484|144465245|SUPERIORITY_OR_OTHER|||||||0.933||95.0||||The Benjamini \& Hochberg False Discovery Rate (FDR) approach at critical value 0.1 was used to adjust p-Values among five secondary cognition endpoints.|constrained Longitudinal Data Analysis|The repeated measures model included the terms site and sequence \* time with a restriction of the same baseline mean across treatment sequences.||||||0.933
72470893|NCT00848484|144465246|SUPERIORITY_OR_OTHER|||||||0.686||95.0||||The Benjamini \& Hochberg False Discovery Rate (FDR) approach at critical value 0.1 was used to adjust p-Values among 5 secondary cognition endpoints.|constrained Longitudinal Data Analysis|The repeated measures model included the terms site and sequence \* time with a restriction of the same baseline mean across treatment sequences.||||||0.686
72470894|NCT00848484|144465247|SUPERIORITY_OR_OTHER|||||||0.686||95.0||||The Benjamini \& Hochberg False Discovery Rate (FDR) approach at critical value 0.1 was used to adjust p-Values among five secondary cognition endpoints.|Wilcoxon (Mann-Whitney)|The repeated measures model included the terms site and sequence \* time with a restriction of the same baseline mean across treatment sequences.||||||0.686
72470895|NCT00848484|144465248|SUPERIORITY_OR_OTHER|||||||0.686||95.0||||The Benjamini \& Hochberg False Discovery Rate (FDR) approach at critical value 0.1 was used to adjust p-Values among 5 secondary cognition endpoints.|constrained Longitudinal Data Analysis|The repeated measures model included the terms site and sequence \* time with a restriction of the same baseline mean across treatment sequences.||||||0.686
72470896|NCT03355209|144465253|SUPERIORITY||Median Difference (A-P)|-19.88||||0.0008|TWO_SIDED|95.0|-31.02|-8.74|||Wilcoxon (Mann-Whitney)||Hodges-Lehmann (HL) method|||-8.74|-31.02|0.0008
72470897|NCT03355209|144465256|SUPERIORITY||Median Difference (A-P)|-10.5||||0.146|TWO_SIDED|95.0|-24.99|3.99|||Wilcoxon (Mann-Whitney)||Hodges-Lehmann (HL) method|||3.99|-24.99|0.1460
72470898|NCT03355209|144465257|SUPERIORITY||Odds Ratio (OR)|3.3||||0.0051|TWO_SIDED|95.0|1.43|7.59|||Regression, Logistic|||||7.59|1.43|0.0051
72470899|NCT03355209|144465257|SUPERIORITY||Odds Ratio (OR)|2.87||||0.015|TWO_SIDED|95.0|1.23|6.7|||Regression, Logistic|||||6.70|1.23|0.0150
72470900|NCT03355209|144465258|SUPERIORITY||Odds Ratio (OR)|1.58||||0.1565|TWO_SIDED|95.0|0.84|2.97|||Cochran-Mantel-Haenszel|||Visit 12||2.97|0.84|0.1565
72470901|NCT03355209|144465258|SUPERIORITY||Odds Ratio (OR)|1.86||||0.0567|TWO_SIDED|95.0|0.98|3.52|||Cochran-Mantel-Haenszel|||Visit 12||3.52|0.98|0.0567
72470902|NCT02097303|144465303|OTHER||||||<|1e-05||||||Comparison of ALP levels before and after treatment|t-test, 2 sided|||||||<.00001
72470903|NCT02097303|144465303|OTHER|||||||0.487||||||Comparison of PSA levels before and after treatment|t-test, 2 sided|||||||0.4870
72470904|NCT02975102|144465315|NON_INFERIORITY|A sample size of 33 evaluable patients per treatment group was calculated to provide at least 90% power to demonstrate non-inferiority of CBL-101 to Vismed Multi. Assumptions included a non-inferiority margin of 2 grades and a standard deviation of 2.5|Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.4|||TWO_SIDED|95.0|-1.2|0.3|||||Treatment difference : CBL-101 - Vismed Multi|||0.3|-1.2|
72470905|NCT02975102|144465316|SUPERIORITY||||||>|0.05||||||Significance level of 0.05|ANCOVA|Adjustment for baseline||||||> 0.05
72470906|NCT02975102|144465317|SUPERIORITY|||||||0.0002||||||Significance level of 0.05|ANCOVA|Adjustment for baseline||||||0.0002
72470907|NCT02975102|144465318|SUPERIORITY||||||>|0.05||||||Significance level of 0.05|ANCOVA|Adjustment for baseline||||||> 0.05
72470908|NCT02975102|144465319|SUPERIORITY||||||>|0.05||||||Significance level of 0.05|ANCOVA|Adjustment for baseline||||||> 0.05
72470909|NCT02975102|144465320|SUPERIORITY|||||||0.0186||||||Significance level of 0.05|ANCOVA|Adjustment for baseline||||||0.0186
72470910|NCT02975102|144465321|SUPERIORITY||||||>|0.05||||||Significance level of 0.05|ANCOVA|Adjustment for baseline||||||> 0.05
72470911|NCT02975102|144465322|SUPERIORITY||||||>|0.05||||||Significance level of 0.05|ANCOVA|Adjustment for baseline||||||> 0.05
72470912|NCT02975102|144465323|SUPERIORITY|||||||0.0011||||||Significance level of 0.05|ANCOVA|Adjustment for baseline||||||0.0011
72470913|NCT02975102|144465324|SUPERIORITY||||||>|0.05||||||Significance level of 0.05|ANCOVA|Adjustment for baseline||||||> 0.05
72470914|NCT02975102|144465325|SUPERIORITY||||||>|0.05||||||Significance level of 0.05|ANCOVA|Adjustment for baseline||||||> 0.05
72470915|NCT02975102|144465326|SUPERIORITY|||||||0.005||||||Significance level of 0.05|ANCOVA|Adjustment for baseline||||||0.005
72470916|NCT02975102|144465327|SUPERIORITY|||||||0.0008||||||Significance level of 0.05|ANCOVA|Adjustment for baseline||||||0.0008
72470917|NCT02975102|144465328|SUPERIORITY|||||||0.0026||||||Significance level of 0.05|ANCOVA|Adjustment for baseline||||||0.0026
72470918|NCT02975102|144465329|SUPERIORITY|||||||0.077||||||Significance level of 0.05 . P-Value result provided only for Global Question|ANCOVA|Adjustment for baseline||||||0.077
72622682|NCT01592747|144775473|SUPERIORITY_OR_OTHER||Least squares mean difference|0.3||||0.4362|TWO_SIDED|95.0|-0.4|0.9|||ANCOVA|||||0.9|-0.4|0.4362
72622683|NCT01592747|144775474|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.1||||0.7182|TWO_SIDED|95.0|-0.8|0.6|||ANCOVA|||||0.6|-0.8|0.7182
72622684|NCT01592747|144775474|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.1||||0.839|TWO_SIDED|95.0|-0.8|0.6|||ANCOVA|||||0.6|-0.8|0.8390
72470919|NCT02975102|144465330|SUPERIORITY|||||||0.6097||||||Significance level of 0.05|ANCOVA|Adjustment for baseline||||||0.6097
72470920|NCT02975102|144465331|SUPERIORITY|||||||0.231||||||Significance level of 0.05|ANCOVA|Adjustment for baseline||||||0.231
72470921|NCT02975102|144465332|SUPERIORITY|||||||0.0135||||||Significance level of 0.05|ANCOVA|Adjustment for baseline||||||0.0135
72470922|NCT02975102|144465333|SUPERIORITY|||||||0.575||||||Significance level of 0.05|ANCOVA|Adjustment for baseline||||||0.575
72470923|NCT04069585|144465341|NON_INFERIORITY|To achieve non-inferiority, the observed p-value must be \<= 0.5 taking into account of the non-inferiority margin (i.e., 10mm difference in Pain VAS between the two treatment groups).|||||<|0.0002||||||One-sided paired t-test|t-test, 1 sided|||||||<0.0002
72505362|NCT00553787|144541781|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.44|STANDARD_ERROR_OF_MEAN|0.169||0.0018|TWO_SIDED|95.0|1.15|1.81||Intersection-union method applied in a step-down testing approach|Regression, Logistic|||With at least 500 subjects in each of the 3 arms in this trial, the trial has more than 90% power to detect a difference of at least 3.1% between combination and placebo treatment assuming a standard deviation of 5.3% and a significance level of 0.05.||1.81|1.15|0.0018
72505363|NCT01088412|144541782|SUPERIORITY_OR_OTHER||Standardized Incidence Ratio|3.77|||||TWO_SIDED|95.0|2.24|5.96||||||Epidemiological comparison between incidence of type 2 diabetes in study versus general population registry data, stratified by age and ethnicity.||5.96|2.24|
72505364|NCT01088412|144541783|SUPERIORITY_OR_OTHER||Standardized Incidence Ratio|0.71|||||TWO_SIDED|95.0|0.39|1.2||||||Epidemiological comparison between incidence of primary malignancies in study versus general population registry data, stratified by age and gender.||1.20|0.39|
72505365|NCT01088412|144541790|SUPERIORITY_OR_OTHER||Standardized Incidence Ratio|3.03|||||TWO_SIDED|95.0|2.14|4.15||||||"Epidemiological comparison between incidence of type 2 diabetes in study versus general population registry data, stratified by age and ethnicity.~Standardized Incidence Ratio for All DM (T1, T2 and DM Not Otherwise Specified \[NOS\] Combined)"||4.15|2.14|
72505366|NCT01088412|144541790|SUPERIORITY_OR_OTHER||Standardized Incidence Ratio|2.74|||||TWO_SIDED|95.0|1.72|4.15||||||"Epidemiological comparison between incidence of type 2 diabetes in study versus general population registry data, stratified by age and ethnicity.~Standardized Incidence Ratio for GHD DM (T1, T2 and DM NOS Combined)"||4.15|1.72|
72565595|NCT02709486|144662683|SUPERIORITY|A step-down testing procedure within each of the primary outcome measures was applied to maintain Type I error. Tanezumab 5 mg versus placebo was tested first and if found significant, then the testing was continued for Tanezumab 2.5 mg versus placebo. A tanezumab treatment group was declared as superior to placebo if the corresponding treatment contrast was significant over all 3 primary outcome measures.|Least Square Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.07||0.0051|TWO_SIDED|95.0|-0.32|-0.06||Threshold for significance at 0.05 level.|ANCOVA|||Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline PGA of osteoarthritis and baseline diary average pain as covariates, and study site as a random effect.||-0.06|-0.32|0.0051
72470924|NCT01441635|144465357|SUPERIORITY||LS Mean Difference|-205.9|STANDARD_ERROR_OF_MEAN|45.1|<|0.001|TWO_SIDED|95.0|-295.77|-116.01|||ANCOVA|ANCOVA model with treatment as a factor and baseline as a covariate.||||-116.01|-295.77|< 0.001
72470925|NCT01441635|144465357|SUPERIORITY||LS Mean Difference|-189.9|STANDARD_ERROR_OF_MEAN|44.36|<|0.001|TWO_SIDED|95.0|-278.33|-101.53|||ANCOVA|ANCOVA model with treatment as a factor and baseline as a covariate.||||-101.53|-278.33|< 0.001
72505367|NCT01088412|144541790|SUPERIORITY_OR_OTHER||Standardized Incidence Ratio|4.91|||||TWO_SIDED|95.0|1.8|10.69||||||"Epidemiological comparison between incidence of type 2 diabetes in study versus general population registry data, stratified by age and ethnicity.~Standardized Incidence Ratio for TS DM (T1, T2 and DM NOS Combined)"||10.69|1.80|
72505368|NCT01088412|144541790|SUPERIORITY_OR_OTHER||Standardized Incidence Ratio|3.1|||||TWO_SIDED|95.0|0.84|7.93||||||"Epidemiological comparison between incidence of type 2 diabetes in study versus general population registry data, stratified by age and ethnicity.~Standardized Incidence Ratio for ISS DM (T1, T2 and DM NOS Combined)"||7.93|0.84|
72576673|NCT00094861|144680138|SUPERIORITY_OR_OTHER||Chi-Square Statistic|-2.5325||||0.1115||95.0||||Generalized Cochran-Mantel-Haenszel test for general association. Participants who never received radiotherapy were assumed to have unplanned breaks.|Cochran-Mantel-Haenszel|Stratified by disease stage, ECOG performance status, and estimated weight loss in the 3 months before study randomization.||||||0.1115
72470926|NCT01441635|144465357|SUPERIORITY||LS Mean Difference|-138.0|STANDARD_ERROR_OF_MEAN|40.86||0.001|TWO_SIDED|95.0|-220.18|-55.76|||ANCOVA|ANCOVA model with treatment as a factor and baseline as a covariate.||||-55.76|-220.18|0.001
72470927|NCT01441635|144465357|SUPERIORITY||LS Mean Difference|-130.6|STANDARD_ERROR_OF_MEAN|37.68||0.001|TWO_SIDED|95.0|-206.7|-54.6|||ANCOVA|ANCOVA model with treatment as a factor and baseline as a covariate.||||-54.60|-206.70|0.001
72470928|NCT01441635|144465358|SUPERIORITY||LS Mean Difference|-75.6|STANDARD_ERROR_OF_MEAN|13.71|<|0.001|TWO_SIDED|95.0|-102.93|-48.28|||ANCOVA|ANCOVA model with treatment as a factor and baseline as a covariate.||||-48.28|-102.93|< 0.001
72470929|NCT01441635|144465358|SUPERIORITY||LS Mean Difference|-64.27|STANDARD_ERROR_OF_MEAN|13.48|<|0.001|TWO_SIDED|95.0|-91.14|-37.39|||ANCOVA|ANCOVA model with treatment as a factor and baseline as a covariate.||||-37.39|-91.14|< 0.001
72470930|NCT01441635|144465358|SUPERIORITY||LS Mean Difference|-67.67|STANDARD_ERROR_OF_MEAN|22.73||0.005|TWO_SIDED|95.0|-113.39|-21.96|||ANCOVA|ANCOVA model with treatment as a factor and baseline as a covariate.||||-21.96|-113.39|0.005
72470931|NCT01441635|144465358|SUPERIORITY||LS mean Difference|-56.84|STANDARD_ERROR_OF_MEAN|8.12|<|0.001|TWO_SIDED|95.0|-73.24|-40.45|||ANCOVA|ANCOVA model with treatment as a factor and baseline as a covariate.||||-40.45|-73.24|< 0.001
72470932|NCT01441635|144465359|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||< 0.001
72470933|NCT01441635|144465359|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||< 0.001
72470934|NCT01441635|144465359|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||< 0.001
72470935|NCT01441635|144465359|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||< 0.001
72470936|NCT01441635|144465360|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||< 0.001
72470937|NCT01441635|144465360|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||< 0.001
72470938|NCT01441635|144465360|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||< 0.001
72505369|NCT01088412|144541790|SUPERIORITY_OR_OTHER||Standardized Incidence Ratio|0.0|||||TWO_SIDED|95.0|0.0|11.83||||||"Epidemiological comparison between incidence of type 2 diabetes in study versus general population registry data, stratified by age and ethnicity.~Standardized Incidence Ratio for SHOX-D DM (T1, T2 and DM NOS Combined)"||11.83|0.00|
72505370|NCT01088412|144541790|SUPERIORITY_OR_OTHER||Standardized Incidence Ratio|3.0|||||TWO_SIDED|95.0|0.36|10.83||||||"Epidemiological comparison between incidence of type 2 diabetes in study versus general population registry data, stratified by age and ethnicity.~Standardized Incidence Ratio for SGA DM (T1, T2 and DM NOS Combined)"||10.83|0.36|
72505371|NCT01088412|144541790|SUPERIORITY_OR_OTHER||Standardized Incidence Ratio|4.55|||||TWO_SIDED|95.0|1.24|11.66||||||"Epidemiological comparison between incidence of type 2 diabetes in study versus general population registry data, stratified by age and ethnicity.~Standardized Incidence Ratio for Other DM (T1, T2 and DM NOS Combined)"||11.66|1.24|
72505372|NCT01088412|144541790|SUPERIORITY_OR_OTHER||Standardized Incidence Ratio|0.0|||||TWO_SIDED|95.0|0.0|24.3||||||"Epidemiological comparison between incidence of type 2 diabetes in study versus general population registry data, stratified by age and ethnicity.~Standardized Incidence Ratio for Unknown DM (T1, T2 and DM NOS Combined)"||24.30|0.00|
72505373|NCT01088412|144541790|SUPERIORITY_OR_OTHER||Standardized Incidence Ratio|0.92|||||TWO_SIDED|95.0|0.56|1.44||||||"Epidemiological comparison between incidence of type 2 diabetes in study versus general population registry data, stratified by age and ethnicity.~Standardized Incidence Ratio for All T1 DM."||1.44|0.56|
72505374|NCT01088412|144541790|SUPERIORITY_OR_OTHER||Standardized Incidence Ratio|0.76|||||TWO_SIDED|95.0|0.36|1.4||||||"Epidemiological comparison between incidence of type 2 diabetes in study versus general population registry data, stratified by age and ethnicity.~Standardized Incidence Ratio for GHD T1DM."||1.40|0.36|
72505375|NCT01088412|144541790|SUPERIORITY_OR_OTHER||Standardized Incidence Ratio|1.5|||||TWO_SIDED|95.0|0.31|4.38||||||"Epidemiological comparison between incidence of type 2 diabetes in study versus general population registry data, stratified by age and ethnicity.~Standardized Incidence Ratio for TS T1DM."||4.38|0.31|
72505376|NCT01088412|144541790|SUPERIORITY_OR_OTHER||Standardized Incidence Ratio|1.42|||||TWO_SIDED|95.0|0.29|4.14||||||"Epidemiological comparison between incidence of type 2 diabetes in study versus general population registry data, stratified by age and ethnicity.~Standardized Incidence Ratio for ISS T1DM."||4.14|0.29|
72505377|NCT01088412|144541790|SUPERIORITY_OR_OTHER||Standardized Incidence Ratio|0.0|||||TWO_SIDED|95.0|0.0|7.23||||||"Epidemiological comparison between incidence of type 2 diabetes in study versus general population registry data, stratified by age and ethnicity.~Standardized Incidence Ratio for SHOX-D T1DM."||7.23|0.00|
72505378|NCT01088412|144541790|SUPERIORITY_OR_OTHER||Standardized Incidence Ratio|0.0|||||TWO_SIDED|95.0|0.0|3.38||||||"Epidemiological comparison between incidence of type 2 diabetes in study versus general population registry data, stratified by age and ethnicity.~Standardized Incidence Ratio for SGA T1DM."||3.38|0.00|
72505379|NCT01088412|144541790|SUPERIORITY_OR_OTHER||Standardized Incidence Ratio]|2.09|||||TWO_SIDED|95.0|0.43|6.1||||||"Epidemiological comparison between incidence of type 2 diabetes in study versus general population registry data, stratified by age and ethnicity.~Standardized Incidence Ratio for Other T1DM."||6.10|0.43|
72505380|NCT01088412|144541790|SUPERIORITY_OR_OTHER||Standardized Incidence Ratio]|0.0|||||TWO_SIDED|95.0|0.0|14.84||||||"Epidemiological comparison between incidence of type 2 diabetes in study versus general population registry data, stratified by age and ethnicity.~Standardized Incidence Ratio for Unknown T1DM."||14.84|0.00|
72470939|NCT01441635|144465360|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||< 0.001
72470940|NCT01441635|144465361|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||< 0.001
72470941|NCT01441635|144465361|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||< 0.001
72470942|NCT01441635|144465361|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||< 0.001
72470943|NCT01441635|144465361|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||< 0.001
72470944|NCT01441635|144465363|SUPERIORITY||LS Mean Difference|1.8|STANDARD_ERROR_OF_MEAN|0.4|<|0.001|TWO_SIDED|95.0|0.97|2.56|||ANCOVA|ANCOVA model with treatment as a factor and baseline as a covariate.||||2.56|0.97|< 0.001
72470945|NCT01441635|144465363|SUPERIORITY||LS Mean Difference|1.8|STANDARD_ERROR_OF_MEAN|0.39|<|0.001|TWO_SIDED|95.0|1.0|2.56|||ANCOVA|ANCOVA model with treatment as a factor and baseline as a covariate.||||2.56|1.00|< 0.001
72470946|NCT01441635|144465363|SUPERIORITY||LS Mean Difference|0.9|STANDARD_ERROR_OF_MEAN|0.4||0.024|TWO_SIDED|95.0|0.13|1.75|||ANCOVA|ANCOVA model with treatment as a factor and baseline as a covariate.||||1.75|0.13|0.024
72470947|NCT01441635|144465363|SUPERIORITY||LS Mean Difference|0.9|STANDARD_ERROR_OF_MEAN|0.3||0.005|TWO_SIDED|95.0|0.28|1.51|||ANCOVA|ANCOVA model with treatment as a factor and baseline as a covariate.||||1.51|0.28|0.005
72470948|NCT01441635|144465364|SUPERIORITY||LS Mean Difference|-0.36|STANDARD_ERROR_OF_MEAN|0.14||0.011|TWO_SIDED|95.0|-0.63|-0.08|||ANCOVA|ANCOVA model with treatment as a factor and baseline as a covariate.||||-0.08|-0.63|0.011
72470949|NCT01441635|144465364|SUPERIORITY||LS Mean Difference|-0.31|STANDARD_ERROR_OF_MEAN|0.14||0.03|TWO_SIDED|95.0|-0.59|-0.03|||ANCOVA|ANCOVA model with treatment as a factor and baseline as a covariate.||||-0.03|-0.59|0.030
72505381|NCT01088412|144541790|SUPERIORITY_OR_OTHER||Standardized Incidence Ratio|3.79|||||TWO_SIDED|95.0|2.24|5.96||||||"Epidemiological comparison between incidence of type 2 diabetes in study versus general population registry data, stratified by age and ethnicity.~Standardized Incidence Ratio for All T2 DM."||5.96|2.24|
72505382|NCT01088412|144541790|SUPERIORITY_OR_OTHER||Standardized Incidence Ratio|3.93|||||TWO_SIDED|95.0|2.03|6.87||||||"Epidemiological comparison between incidence of type 2 diabetes in study versus general population registry data, stratified by age and ethnicity.~Standardized Incidence Ratio for GHD T2DM."||6.87|2.03|
72505383|NCT01088412|144541790|SUPERIORITY_OR_OTHER||Standardized Incidence Ratio|6.46|||||TWO_SIDED|95.0|1.33|18.89||||||"Epidemiological comparison between incidence of type 2 diabetes in study versus general population registry data, stratified by age and ethnicity.~Standardized Incidence Ratio for TS T2DM."||18.89|1.33|
72505384|NCT01088412|144541790|SUPERIORITY_OR_OTHER||Standardized Incidence Ratio|0.0|||||TWO_SIDED|95.0|0.0|7.52||||||"Epidemiological comparison between incidence of type 2 diabetes in study versus general population registry data, stratified by age and ethnicity.~Standardized Incidence Ratio for ISS T2DM."||7.52|0.00|
72505385|NCT01088412|144541790|SUPERIORITY_OR_OTHER||Standardized Incidence Ratio|0.0|||||TWO_SIDED|95.0|0.0|31.16||||||"Epidemiological comparison between incidence of type 2 diabetes in study versus general population registry data, stratified by age and ethnicity.~Standardized Incidence Ratio for SHOX-D T2DM."||31.16|0.00|
72395325|NCT01571427|144297245|EQUIVALENCE|Power calculation was based on the entire sample which combined CDR=0 and CDR=0.5 groups. Analyses by each CDR group are exploratory.|Mean Difference (Final Values)|0.004|STANDARD_ERROR_OF_MEAN|0.05||0.93|TWO_SIDED||||||Regression, Linear||Estimates reported here is coefficient for the experimental group (with the control group as a reference), using a linear regression model controlling for Geriatric Depression Scale - 15 items version (GDS-15).|Analysis 2: CDR 0 (n=49)||||0.93
72395326|NCT01571427|144297245|EQUIVALENCE|Power calculation was based on the entire sample which combined CDR=0 and CDR=0.5 groups. Analyses by each CDR group are exploratory.|Mean Difference (Final Values)|-0.07|STANDARD_ERROR_OF_MEAN|0.08||0.4|TWO_SIDED||||||Regression, Linear||Estimates reported here is coefficient for the experimental group (with the control group as a reference), using a linear regression model controlling for Geriatric Depression Scale - 15 items version (GDS-15).|Analysis 3: CDR 0.5 (n=34)||||0.40
72395327|NCT01571427|144297246|EQUIVALENCE|It was calculated that 82 participants randomized in a 1:1 fashion between the 2 arms would have at least 80% to detect a Cohen's D of 0.45 in the difference in changes from baseline to week 6 at alpha=0.05 (two tailed). All randomized participants (n=83) were included in the analysis.|Mean Difference (Final Values)|-0.09|STANDARD_ERROR_OF_MEAN|0.09||0.3|TWO_SIDED||||||Regression, Linear||Estimates reported here is coefficient for the experimental group (with the control group as a reference), using a linear regression model controlling for Geriatric Depression Scale - 15 items version (GDS-15).|||||0.30
72470950|NCT01441635|144465364|SUPERIORITY||LS Mean Difference|-0.26|STANDARD_ERROR_OF_MEAN|0.16||0.109|TWO_SIDED|95.0|-0.59|0.06|||ANCOVA|ANCOVA model with treatment as a factor and baseline as a covariate.||||0.06|-0.59|0.109
72470951|NCT01441635|144465364|SUPERIORITY||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.15||0.002|TWO_SIDED|95.0|-0.8|-0.19|||ANCOVA|ANCOVA model with treatment as a factor and baseline as a covariate.||||-0.19|-0.80|0.002
72470952|NCT01441635|144465365|SUPERIORITY||LS Mean Difference|-10.29|STANDARD_ERROR_OF_MEAN|4.32||0.02|TWO_SIDED|95.0|-18.9|-1.67|||ANCOVA|ANCOVA model with treatment as a factor and baseline as a covariate.||||-1.67|-18.90|0.020
72470953|NCT01441635|144465365|SUPERIORITY||LS Mean Difference|-7.62|STANDARD_ERROR_OF_MEAN|4.39||0.087|TWO_SIDED|95.0|-16.36|1.13|||ANCOVA|ANCOVA model with treatment as a factor and baseline as a covariate.||||1.13|-16.36|0.087
72470954|NCT01441635|144465365|SUPERIORITY||LS Mean Difference|-8.81|STANDARD_ERROR_OF_MEAN|4.28||0.045|TWO_SIDED|95.0|-17.43|-0.19|||ANCOVA|ANCOVA model with treatment as a factor and baseline as a covariate.||||-0.19|-17.43|0.045
72470955|NCT01441635|144465365|SUPERIORITY||LS Mean Difference|-13.69|STANDARD_ERROR_OF_MEAN|4.14||0.002|TWO_SIDED|95.0|-22.06|-5.32|||ANCOVA|ANCOVA model with treatment as a factor and baseline as a covariate.||||-5.32|-22.06|0.002
72470956|NCT01441635|144465366|SUPERIORITY||LS Mean Difference|-5.51|STANDARD_ERROR_OF_MEAN|2.03||0.008|TWO_SIDED|95.0|-9.56|-1.47|||ANCOVA|ANCOVA model with treatment as a factor and baseline as a covariate.||||-1.47|-9.56|0.008
72470957|NCT01441635|144465366|SUPERIORITY||LS Mean Difference|-4.95|STANDARD_ERROR_OF_MEAN|2.08||0.02|TWO_SIDED|95.0|-9.11|-0.8|||ANCOVA|||||-0.80|-9.11|0.020
72470958|NCT01441635|144465366|SUPERIORITY||LS Mean Difference|-3.63|STANDARD_ERROR_OF_MEAN|2.75||0.194|TWO_SIDED|95.0|-9.18|1.91|||ANCOVA|ANCOVA model with treatment as a factor and baseline as a covariate.||||1.91|-9.18|0.194
72470959|NCT01441635|144465366|SUPERIORITY||LS Mean Difference|-7.2|STANDARD_ERROR_OF_MEAN|2.04||0.001|TWO_SIDED|95.0|-11.33|-3.07|||ANCOVA|ANCOVA model with treatment as a factor and baseline as a covariate.||||-3.07|-11.33|0.001
72470960|NCT01441635|144465369|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|One-way Kruskal-Wallis test with treatment as a factor.||||||< 0.001
72470961|NCT01441635|144465369|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|One-way Kruskal-Wallis test with treatment as a factor.||||||< 0.001
72470962|NCT01441635|144465369|SUPERIORITY|||||||0.052|||||||Kruskal-Wallis|One-way Kruskal-Wallis test with treatment as a factor.||||||0.052
72470963|NCT01441635|144465369|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|One-way Kruskal-Wallis test with treatment as a factor.||||||< 0.001
72470964|NCT01441635|144465370|SUPERIORITY|||||||0.003|||||||Fisher Exact|||||||0.003
72470965|NCT01441635|144465370|SUPERIORITY|||||||0.016|||||||Fisher Exact|||||||0.016
72470966|NCT01441635|144465370|SUPERIORITY|||||||0.012|||||||Fisher Exact|||||||0.012
72470967|NCT01441635|144465370|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||< 0.001
72470968|NCT01441635|144465371|SUPERIORITY|||||||0.161|||||||Kruskal-Wallis|One-way Kruskal-Wallis test with treatment as a factor||||||0.161
72470969|NCT01441635|144465371|SUPERIORITY|||||||0.173|||||||Kruskal-Wallis|One-way Kruskal-Wallis test with treatment as a factor.||||||0.173
72470970|NCT01441635|144465371|SUPERIORITY|||||||0.072|||||||Kruskal-Wallis|One-way Kruskal-Wallis test with treatment as a factor.||||||0.072
72470971|NCT01441635|144465371|SUPERIORITY|||||||0.003|||||||Kruskal-Wallis|One-way Kruskal-Wallis test with treatment as a factor.||||||0.003
72470972|NCT01441635|144465372|SUPERIORITY|||||||0.203|||||||Fisher Exact|||||||0.203
72470973|NCT01441635|144465372|SUPERIORITY|||||||0.342|||||||Fisher Exact|||||||0.342
72470974|NCT01441635|144465372|SUPERIORITY|||||||0.038|||||||Fisher Exact|||||||0.038
72470975|NCT01441635|144465372|SUPERIORITY|||||||0.111|||||||Fisher Exact|||||||0.111
72470976|NCT01825577|144465377|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.9||||0.55|TWO_SIDED||||||t-test, 2 sided|||||||.55
72470977|NCT01825577|144465378|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.1||||0.67|TWO_SIDED||||||t-test, 2 sided|||||||.67
72470978|NCT00358644|144465379|SUPERIORITY_OR_OTHER||Percentage of Participants|23.6||||||95.0|13.2|37.0||||||||37.0|13.2|
72470979|NCT03332784|144465413|SUPERIORITY||||||<|0.0001||||||The p-value for each treatment group is for the comparison of that treatment group to the placebo treatment group.|ANOVA|||||||<0.0001
72470980|NCT03332784|144465413|SUPERIORITY||||||<|0.0001||||||The p-value for each treatment group is for the comparison of that treatment group to the placebo treatment group.|ANOVA|||||||<0.0001
72470981|NCT03332784|144465413|SUPERIORITY|||||||0.0001||||||The p-value for each treatment group is for the comparison of that treatment group to the placebo treatment group.|ANOVA|||||||0.0001
72470982|NCT01055704|144465419|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.048|STANDARD_ERROR_OF_MEAN|0.389||0.902|TWO_SIDED|95.0|-0.835|0.739|||ANCOVA|Error degrees of freedom adjusted for number of missing values imputed.||Data were analyzed using analysis of covariance (ANCOVA) with gender and/or BMI included as covariates.||0.739|-0.835|0.902
72505386|NCT01088412|144541790|SUPERIORITY_OR_OTHER||Standardized Incidence Ratio|7.9|||||TWO_SIDED|95.0|0.96|28.52||||||"Epidemiological comparison between incidence of type 2 diabetes in study versus general population registry data, stratified by age and ethnicity.~Standardized Incidence Ratio for SGA T2DM."||28.52|0.96|
72395328|NCT01571427|144297246|EQUIVALENCE|Power calculation was based on the entire sample which combined CDR=0 and CDR=0.5 groups. Analyses by each CDR group are exploratory.|Mean Difference (Final Values)|0.03|STANDARD_ERROR_OF_MEAN|0.1||0.75|TWO_SIDED||||||Regression, Linear||Estimates reported here is coefficient for the experimental group (with the control group as a reference), using a linear regression model controlling for Geriatric Depression Scale - 15 items version (GDS-15).|Analysis 2: CDR 0 (n=49)||||0.75
72395329|NCT01571427|144297246|EQUIVALENCE|Power calculation was based on the entire sample which combined CDR=0 and CDR=0.5 groups. Analyses by each CDR group are exploratory.|Mean Difference (Final Values)|-0.24|STANDARD_ERROR_OF_MEAN|0.15||0.12|TWO_SIDED||||||Regression, Linear||Estimates reported here is coefficient for the experimental group (with the control group as a reference), using a linear regression model controlling for Geriatric Depression Scale - 15 items version (GDS-15).|Analysis 3: CDR 0.5 (n=34)||||0.12
72505387|NCT01088412|144541790|SUPERIORITY_OR_OTHER||Standardized Incidence Ratio|3.0|||||TWO_SIDED|95.0|0.08|16.7||||||"Epidemiological comparison between incidence of type 2 diabetes in study versus general population registry data, stratified by age and ethnicity.~Standardized Incidence Ratio for Other T2DM."||16.70|0.08|
72505388|NCT01088412|144541790|SUPERIORITY_OR_OTHER||Standardized Incidence Ratio|0.0|||||TWO_SIDED|95.0|0.0|63.97||||||"Epidemiological comparison between incidence of type 2 diabetes in study versus general population registry data, stratified by age and ethnicity.~Standardized Incidence Ratio for Unknown T2DM."||63.97|0.00|
72505389|NCT02285010|144541791|NON_INFERIORITY|Definition: 50% reduction of morphine consumption Type I error (alpha) 0.05, Type II error (beta) 80%||||||0.6|||||||Wilcoxon (Mann-Whitney)|||||||0.60
72505390|NCT02285010|144541792|NON_INFERIORITY|Alpha 0.05, Beta 80%||||||0.1|||||||Wilcoxon (Mann-Whitney)|||||||0.10
72505391|NCT02285010|144541793|NON_INFERIORITY|alpha 0.05, beta 80%||||||0.33|||||||Wilcoxon (Mann-Whitney)|||for NRS at rest||||0.33
72505392|NCT02285010|144541793|NON_INFERIORITY|alpha 0.05, beta 80%||||||0.75|||||||Wilcoxon (Mann-Whitney)|||for NRS at movement||||0.75
72505393|NCT02285010|144541794|NON_INFERIORITY|alpha 0.05, beta 80%||||||0.16|||||||Chi-squared|||For pruritus||||0.16
72505394|NCT02285010|144541794|NON_INFERIORITY|Alpha 0.05, beta 80%||||||0.66|||||||Chi-squared|||For Nausea||||0.66
72505395|NCT02285010|144541794|NON_INFERIORITY|alpha 0.05, beta 80%||||||0.46|||||||Chi-squared|||For Vomiting||||0.46
72622685|NCT01592747|144775475|SUPERIORITY_OR_OTHER||Least squares mean difference|0.7||||0.0813|TWO_SIDED|95.0|-0.1|1.4|||ANCOVA|||||1.4|-0.1|0.0813
72505396|NCT02285010|144541794|NON_INFERIORITY|Alpha 0.05, beta 80%||||||0.54|||||||Chi-squared|||For Dizziness||||0.54
72505397|NCT02285010|144541794|NON_INFERIORITY|Alpha 0.05, beta 80%||||||0.05|||||||Chi-squared|||For visual disturbance||||0.05
72505398|NCT02285010|144541795|NON_INFERIORITY|Alpha 0.05, beta 80%||||||0.05||||||P-Value 0.05 was calculated.|Chi-squared|||||||0.05
72505399|NCT01333189|144541797|SUPERIORITY_OR_OTHER||||||=|0.329|TWO_SIDED||||||Mixed Models Analysis|||||||=0.329
72505400|NCT01333189|144541798|SUPERIORITY_OR_OTHER||||||=|0.891|TWO_SIDED||||||Mixed Models Analysis|||||||=0.891
72505401|NCT01333189|144541799|SUPERIORITY_OR_OTHER||||||=|0.021|TWO_SIDED||||||Mixed Models Analysis|||||||=0.021
72505402|NCT01333189|144541800|SUPERIORITY_OR_OTHER||||||=|0.509|TWO_SIDED||||||Mixed Models Analysis|||Internal moment at the hip||||=0.509
72505403|NCT01333189|144541800|SUPERIORITY_OR_OTHER||||||=|0.5|TWO_SIDED||||||Mixed Models Analysis|||Internal moment at the knee||||=0.500
72505404|NCT01333189|144541800|SUPERIORITY_OR_OTHER||||||=|0.607|TWO_SIDED||||||Mixed Models Analysis|||Internal moment at the ankle||||=0.607
72505405|NCT01333189|144541801|SUPERIORITY_OR_OTHER||||||=|0.068|TWO_SIDED||||||Mixed Models Analysis|||||||=0.068
72505406|NCT01333189|144541802|SUPERIORITY_OR_OTHER||||||=|0.48|TWO_SIDED||||||Mixed Models Analysis|||Internal moment at the hip||||=0.480
72505407|NCT01333189|144541802|SUPERIORITY_OR_OTHER||||||=|0.12|TWO_SIDED||||||Mixed Models Analysis|||Internal moment at the knee||||=0.120
72505408|NCT01333189|144541802|SUPERIORITY_OR_OTHER||||||=|0.668|TWO_SIDED||||||Mixed Models Analysis|||Internal moment at the ankle||||=0.668
72505409|NCT01333189|144541803|SUPERIORITY_OR_OTHER||||||=|0.511|TWO_SIDED||||||Mixed Models Analysis|||||||=0.511
72505410|NCT01333189|144541804|SUPERIORITY_OR_OTHER||||||=|0.402|TWO_SIDED||||||Mixed Models Analysis|||||||=0.402
72505411|NCT01333189|144541805|SUPERIORITY_OR_OTHER||||||=|0.021|TWO_SIDED||||||Mixed Models Analysis|||||||=0.021
72505412|NCT01333189|144541806|SUPERIORITY_OR_OTHER||||||=|0.686|TWO_SIDED||||||Mixed Models Analysis|||Internal moment at the hip||||=0.686
72505413|NCT01333189|144541806|SUPERIORITY_OR_OTHER||||||=|0.434|TWO_SIDED||||||Mixed Models Analysis|||Internal moment at the knee||||=0.434
72505414|NCT01333189|144541806|SUPERIORITY_OR_OTHER||||||=|0.227|TWO_SIDED||||||Mixed Models Analysis|||Internal moment at the ankle||||=0.227
72505415|NCT01333189|144541807|SUPERIORITY_OR_OTHER||||||=|0.068|TWO_SIDED||||||Mixed Models Analysis|||||||=0.068
72505416|NCT01333189|144541808|SUPERIORITY_OR_OTHER||||||=|0.16|TWO_SIDED||||||Mixed Models Analysis|||Internal moment at the hip||||=0.160
72505417|NCT01333189|144541808|SUPERIORITY_OR_OTHER||||||=|0.008|TWO_SIDED||||||Mixed Models Analysis|||Internal moment at the knee||||=0.008
72505418|NCT01333189|144541808|SUPERIORITY_OR_OTHER||||||=|0.877|TWO_SIDED||||||Mixed Models Analysis|||Internal moment at the ankle||||=0.877
72505419|NCT02218203|144541810|OTHER|We report the interaction between the lidocaine dose response and dextromethorphan dose response. The type of statistical test was a linear regression model with Chi-square test.|Lidocaine dose*dextromethorphan dose|0.0042|STANDARD_ERROR_OF_MEAN|0.002||0.0322|TWO_SIDED|95.0|0.0004|0.0081|||Pearson's Chi-squared test||The estimated value is an estimated interaction term, and not a P-value.|We performed a lidocaine dose response clinical trial nested within a dextromethorphan clinical trial to evaluate a potential interaction between lidocaine dose and dextromethorphan dose (pain intensity; Gracely scale).||0.0081|0.0004|0.0322
72622686|NCT01592747|144775475|SUPERIORITY_OR_OTHER||Least squares mean difference|0.3||||0.4365|TWO_SIDED|95.0|-0.4|1.0|||ANCOVA|||||1.0|-0.4|0.4365
72622687|NCT01592747|144775476|SUPERIORITY_OR_OTHER||Least squares mean difference|0.3||||0.4213|TWO_SIDED|95.0|-0.4|1.0|||ANCOVA|||||1.0|-0.4|0.4213
72622688|NCT01592747|144775476|SUPERIORITY_OR_OTHER||Least squares mean difference|0.3||||0.4267|TWO_SIDED|95.0|-0.4|1.0|||ANCOVA|||||1.0|-0.4|0.4267
72565596|NCT02709486|144662684|SUPERIORITY||Least Square Mean Difference|-0.67|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-0.94|-0.4|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain subscales and baseline diary average pain as covariates, and study site as a random effect.||-0.40|-0.94|<.0001
72565597|NCT02709486|144662684|SUPERIORITY||Least Square Mean Difference|-0.34|STANDARD_ERROR_OF_MEAN|0.14||0.0149|TWO_SIDED|95.0|-0.61|-0.07|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain subscales and baseline diary average pain as covariates, and study site as a random effect.||-0.07|-0.61|0.0149
72565598|NCT02709486|144662684|SUPERIORITY||Least Square Mean Difference|-0.79|STANDARD_ERROR_OF_MEAN|0.15|<|0.0001|TWO_SIDED|95.0|-1.08|-0.5|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain subscales and baseline diary average pain as covariates, and study site as a random effect.||-0.50|-1.08|<.0001
72565599|NCT02709486|144662684|SUPERIORITY||Least Square Mean Difference|-0.78|STANDARD_ERROR_OF_MEAN|0.15|<|0.0001|TWO_SIDED|95.0|-1.07|-0.5|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain subscales and baseline diary average pain as covariates, and study site as a random effect.||-0.50|-1.07|<.0001
72565600|NCT02709486|144662684|SUPERIORITY||Least Square Mean Difference|-0.62|STANDARD_ERROR_OF_MEAN|0.15|<|0.0001|TWO_SIDED|95.0|-0.92|-0.32|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain subscales and baseline diary average pain as covariates, and study site as a random effect.||-0.32|-0.92|<.0001
72565601|NCT02709486|144662684|SUPERIORITY||Least Square Mean Difference|-0.77|STANDARD_ERROR_OF_MEAN|0.15|<|0.0001|TWO_SIDED|95.0|-1.07|-0.47|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain subscales and baseline diary average pain as covariates, and study site as a random effect.||-0.47|-1.07|<.0001
72565602|NCT02709486|144662684|SUPERIORITY||Least Square Mean Difference|-0.72|STANDARD_ERROR_OF_MEAN|0.17|<|0.0001|TWO_SIDED|95.0|-1.05|-0.39|||ANCOVA|||Week 12: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain subscales and baseline diary average pain as covariates, and study site as a random effect.||-0.39|-1.05|<.0001
72395330|NCT01702454|144297247|NON_INFERIORITY_OR_EQUIVALENCE|Criterion: The lower limit (LL) of the two-sided 95% Confidence Interval (CI) for the GMT ratio is above 1|Adjusted GMT ratio|8.97|||||TWO_SIDED|95.0|6.21|12.96|||||The GMTs were used to calculate the Adjusted GMTs, which in turn were used to calculate the Adjusted GMT ratio with 95% confidence interval.|The adjusted GMT of HI antibodies for A/Christchurch strain at post-vaccination dose 1, the GMT ratio of Fluarix Quadrivalent Primed Group/Fluarix Quadrivalent Unprimed Group and the 2-sided 95% CI on each GMT ratio were computed after fitting an ANCOVA model on the logarithm10 transformation of the titers, including the vaccine group as fixed effect and the pre-vaccination log-10 titer and age as regressors.||12.96|6.21|
72565603|NCT02709486|144662684|SUPERIORITY||Least Square Mean Difference|-0.77|STANDARD_ERROR_OF_MEAN|0.17|<|0.0001|TWO_SIDED|95.0|-1.09|-0.44|||ANCOVA|||Week 12: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain subscales and baseline diary average pain as covariates, and study site as a random effect.||-0.44|-1.09|<.0001
72622689|NCT01592747|144775477|SUPERIORITY_OR_OTHER||Least squares mean difference|0.3||||0.3713||95.0|-0.4|1.0|||ANCOVA|||||1.0|-0.4|0.3713
72565604|NCT02709486|144662684|SUPERIORITY||Least Square Mean Difference|-0.59|STANDARD_ERROR_OF_MEAN|0.17||0.0005|TWO_SIDED|95.0|-0.93|-0.26|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain subscales and baseline diary average pain as covariates, and study site as a random effect.||-0.26|-0.93|0.0005
72565605|NCT02709486|144662684|SUPERIORITY||Least Square Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.17||0.0004|TWO_SIDED|95.0|-0.93|-0.27|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain subscales and baseline diary average pain as covariates, and study site as a random effect.||-0.27|-0.93|0.0004
72565606|NCT02709486|144662686|SUPERIORITY||Least Square Mean Difference|-0.69|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-0.95|-0.42|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariates, and study site as a random effect.||-0.42|-0.95|<.0001
72622690|NCT01592747|144775477|SUPERIORITY_OR_OTHER||Least squares mean difference|0.4||||0.2855|TWO_SIDED|95.0|-0.3|1.1|||ANCOVA|||||1.1|-0.3|0.2855
72505420|NCT03461965|144541824|OTHER|p-value \< 0.05 was considered statistically significant||||||0.007|||||||t-test, 2 sided|||Comparing total responses that were correct across all participants in both arms||||0.007
72395331|NCT01702454|144297247|NON_INFERIORITY_OR_EQUIVALENCE|Criterion: The lower limit (LL) of the two-sided 95% Confidence Interval (CI) for the GMT ratio is above 1|Adjusted GMT ratio|2.7|||||TWO_SIDED|95.0|1.81|4.02|||||The GMTs were used to calculate the Adjusted GMTs, which in turn were used to calculate the Adjusted GMT ratio with 95% confidence interval|The adjusted GMT of HI antibodies for A/Victoria strain at post-vaccination dose 1, the GMT ratio of Fluarix Quadrivalent Primed Group/Fluarix Quadrivalent Unprimed Group and the 2-sided 95% CI on each GMT ratio were computed after fitting an ANCOVA model on the logarithm10 transformation of the titers, including the vaccine group as fixed effect and the pre-vaccination log-10 titer and age as regressors.||4.02|1.81|
72395332|NCT01702454|144297247|NON_INFERIORITY_OR_EQUIVALENCE|Criterion: The lower limit (LL) of the two-sided 95% Confidence Interval (CI) for the GMT ratio is above 1|Adjusted GMT ratio|3.94|||||TWO_SIDED|95.0|2.89|5.37|||||The GMTs were used to calculate the Adjusted GMTs, which in turn were used to calculate the Adjusted GMT ratio with 95% confidence interval.|The adjusted GMT of HI antibodies for B/Brisbane strain at post-vaccination dose 1, the GMT ratio of Fluarix Quadrivalent Primed Group/Fluarix Quadrivalent Unprimed Group and the 2-sided 95% CI on each GMT ratio were computed after fitting an ANCOVA model on the logarithm10 transformation of the titers, including the vaccine group as fixed effect and the pre-vaccination log-10 titer and age as regressors.||5.37|2.89|
72395333|NCT01702454|144297247|NON_INFERIORITY_OR_EQUIVALENCE|Criterion: The lower limit (LL) of the two-sided 95% Confidence Interval (CI) for the GMT ratio is above 1|Adjusted GMT ratio|6.71|||||TWO_SIDED|95.0|5.21|8.63|||||The GMTs were used to calculate the Adjusted GMTs, which in turn were used to calculate the Adjusted GMT ratio with 95% confidence interval.|The adjusted GMT of HI antibodies for B/Hub-Wuj strain at post-vaccination dose 1, the GMT ratio of Fluarix Quadrivalent Primed Group/Fluarix Quadrivalent Unprimed Group and the 2-sided 95% CI on each GMT ratio were computed after fitting an ANCOVA model on the logarithm10 transformation of the titers, including the vaccine group as fixed effect and the pre-vaccination log-10 titer and age as regressors.||8.63|5.21|
72395334|NCT01702454|144297249|NON_INFERIORITY_OR_EQUIVALENCE|SCR difference was calculated using standardized asymptotic 95% CI for the group difference in proportion.|Difference in percentages|44.74|||||TWO_SIDED|95.0|35.87|52.84||||||To assess the immune response in terms of SCR difference at Day 7 after one dose of Fluarix Quadrivalent vaccine (2012-2013 formulation) in vaccine-primed and vaccine-unprimed subjects, for all the strains.||52.84|35.87|
72395335|NCT01702454|144297249|NON_INFERIORITY_OR_EQUIVALENCE|SCR difference was calculated using standardized asymptotic 95% CI for the group difference in proportion.|Difference in percentages|45.31|||||TWO_SIDED|95.0|36.58|53.3||||||To assess the immune response in terms of SCR difference at Day 7 after one dose of Fluarix Quadrivalent vaccine (2012-2013 formulation) in vaccine-primed and vaccine-unprimed subjects, for all the strains.||53.3|36.58|
72395336|NCT01702454|144297249|NON_INFERIORITY_OR_EQUIVALENCE|SCR difference was calculated using standardized asymptotic 95% CI for the group difference in proportion.|Difference in percentages|37.86||||||95.0|28.83|46.26||||||To assess the immune response in terms of SCR difference at Day 7 after one dose of Fluarix Quadrivalent vaccine (2012-2013 formulation) in vaccine-primed and vaccine-unprimed subjects, for all the strains.||46.26|28.83|
72395337|NCT01702454|144297249|NON_INFERIORITY_OR_EQUIVALENCE|SCR difference was calculated using standardized asymptotic 95% CI for the group difference in proportion|Difference in percentages|56.0||||||95.0|48.32|63.04||||||"To assess the immune response in terms of SCR difference at Day 7 after one dose of Fluarix Quadrivalent vaccine (2012-2013 formulation) in vaccine-primed and vaccine-unprimed subjects, for all the strains.~B/Hu-Wuj = B/Hubei-Wujiagang/158/2009 (Yamagata)"||63.04|48.32|
72395338|NCT01702454|144297251|NON_INFERIORITY_OR_EQUIVALENCE|SPR difference was calculated using standardized asymptotic 95% CI for the group difference in proportion.|Difference in SPR|62.43|||||TWO_SIDED|95.0|55.27|68.89||||||To assess the immune response in terms of SPR difference at Day 7 after one dose of Fluarix Quadrivalent vaccine (2012-2013 formulation) in vaccine-primed and vaccine-unprimed subjects, for all the strains||68.89|55.27|
72395339|NCT01702454|144297251|NON_INFERIORITY_OR_EQUIVALENCE|SPR difference was calculated using standardized asymptotic 95% CI for the group difference in proportion.|Difference in SPR|47.4|||||TWO_SIDED|95.0|39.08|55.06||||||To assess the immune response in terms of SPR difference at Day 7 after one dose of Fluarix Quadrivalent vaccine (2012-2013 formulation) in vaccine-primed and vaccine-unprimed subjects, for all the strains.||55.06|39.08|
72395340|NCT01702454|144297251|NON_INFERIORITY_OR_EQUIVALENCE|SPR difference was calculated using standardized asymptotic 95% CI for the group difference in proportion|Difference in SPR|56.68|||||TWO_SIDED|95.0|49.44|63.43||||||To assess the immune response in terms of SPR difference at Day 7 after one dose of Fluarix Quadrivalent vaccine (2012-2013 formulation) in vaccine-primed and vaccine-unprimed subjects, for all the strains.||63.43|49.44|
72395341|NCT01702454|144297251|NON_INFERIORITY_OR_EQUIVALENCE|SPR difference was calculated using standardized asymptotic 95% CI for the group difference in proportion.|Difference in SPR|56.72|||||TWO_SIDED|95.0|49.41|63.49||||||"To assess the immune response in terms of SPR difference at Day 7 after one dose of Fluarix Quadrivalent vaccine (2012-2013 formulation) in vaccine-primed and vaccine-unprimed subjects, for all the strains.~B/Hu-Wuj = B/Hubei-Wujiagang/158/2009 (Yamagata)"||63.49|49.41|
72470983|NCT01055704|144465419|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.132|STANDARD_ERROR_OF_MEAN|0.351||0.709|TWO_SIDED|95.0|-0.578|0.841|||ANCOVA|Error degrees of freedom adjusted for number of missing values imputed.||Data were analyzed using analysis of covariance (ANCOVA) with gender and/or BMI included as covariates.||0.841|-0.578|0.709
72505421|NCT03461965|144541825|OTHER|p-value \< 0.05 was considered statistically significant||||||0.0001|||||||t-test, 2 sided|||Difference of pre (baseline) and post-test scores within each treatment group||||0.0001
72505422|NCT03461965|144541825|OTHER|p-value \< 0.05 was considered statistically significant|||||<|0.03|||||||t-test, 2 sided|||Difference of pre (baseline) and post-test scores within each treatment group||||<0.03
72395342|NCT03510884|144297288|SUPERIORITY|Bonferroni adjustment was applied to handle multiplicity for the comparison of each alirocumab dosing regimen group versus its placebo group for the primary efficacy endpoint.|LS mean difference|-43.3|STANDARD_ERROR_OF_MEAN|5.5|<|0.0001|TWO_SIDED|97.5|-56.0|-30.7||The threshold for statistical significance was 0.025 level.|MMRM||Alirocumab Q2W versus Placebo Q2W|The MMRM model included fixed categorical effects of treatment group (alirocumab, placebo), randomization strata (previous participation \[yes or no\] to DFI14223 study, Baseline BW \[\<50 or \>=50 kg\]) as per interactive voice response system (IVRS), time point, treatment-by-time point interaction, strata-by-time point interaction, as well as the continuous fixed covariates of Baseline LDL-C value and Baseline value by time-point interaction. Comparison was performed using an appropriate contrast.||-30.7|-56.0|<0.0001
72395343|NCT03510884|144297288|SUPERIORITY|Bonferroni adjustment was applied to handle multiplicity for the comparison of each alirocumab dosing regimen group versus its placebo group for the primary efficacy endpoint.|LS mean difference|-33.8|STANDARD_ERROR_OF_MEAN|5.5|<|0.0001|TWO_SIDED|97.5|-46.4|-21.2||The threshold for statistical significance was 0.025 level.|MMRM||Alirocumab Q4W versus Placebo Q4W|The MMRM model included the fixed categorical effects of treatment group (alirocumab, placebo), randomization strata (Baseline BW \[\<50 or \>=50 kg\]) as per IVRS, time point, treatment-by-time point interaction, and BW strata-by-time point interaction, as well as the continuous fixed covariates of Baseline LDL-C value and Baseline value by time-point interaction. Comparison was performed using an appropriate contrast.||-21.2|-46.4|<0.0001
72395344|NCT03510884|144297289|SUPERIORITY|Hierarchical testing method was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially in the order the endpoints were reported and independently for each dosing regimen. The hierarchical testing sequence continued only when previous endpoint was statistically significant at 0.025 level. Statistical significance of the primary endpoint was required before testing the first secondary endpoint for each dosing regimen independently.|LS mean difference|-45.5|STANDARD_ERROR_OF_MEAN|4.7|<|0.0001|TWO_SIDED|97.5|-56.3|-34.7||Threshold for significance at 0.025 level.|MMRM||Alirocumab Q2W versus Placebo Q2W|The MMRM model included the fixed categorical effects of treatment group (alirocumab, placebo), randomization strata (previous participation \[yes or no\] to DFI14223 study, Baseline BW \[\<50 or \>=50 kg\]) as per IVRS, time point, treatment-by-time point interaction, strata-by-time point interaction, as well as the continuous fixed covariates of Baseline LDL-C value and Baseline value by time-point interaction. Comparison was performed using an appropriate contrast.||-34.7|-56.3|<0.0001
72395345|NCT03510884|144297289|SUPERIORITY|A hierarchical testing method was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially in the order the endpoints are reported and independently for each dosing regimen. The hierarchical testing sequence continued only when previous endpoint was statistically significant at 0.025 level. Statistical significance of the primary endpoint was required before testing the first secondary endpoint for each dosing regimen independently.|LS mean difference|-41.5|STANDARD_ERROR_OF_MEAN|4.9|<|0.0001|TWO_SIDED|97.5|-52.7|-30.2||Threshold for significance at 0.025 level.|MMRM||Alirocumab Q4W versus Placebo Q4W|The MMRM model included the fixed categorical effects of treatment group (alirocumab, placebo), randomization strata (Baseline BW \[\<50 or \>=50 kg\]) as per IVRS, time point, treatment-by-time point interaction, and BW strata-by-time point interaction, as well as the continuous fixed covariates of Baseline LDL-C value and Baseline value by time-point interaction. Comparison was performed using an appropriate contrast.||-30.2|-52.7|<0.0001
72395346|NCT03510884|144297290|SUPERIORITY|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the considered dosing regimen).|LS mean difference|-37.8|STANDARD_ERROR_OF_MEAN|4.2|<|0.0001|TWO_SIDED|97.5|-47.5|-28.2||Threshold for significance at 0.025 level.|MMRM||Alirocumab Q2W versus Placebo Q2W|The MMRM model included the fixed categorical effects of treatment group (alirocumab, placebo), randomization strata (previous participation \[yes or no\] to DFI14223 study, Baseline BW \[\<50 or \>=50 kg\]) as per IVRS, time point, treatment-by-time point interaction, strata-by-time point interaction, as well as the continuous fixed covariates of Baseline Apo B value and Baseline Apo B value by time-point interaction. Comparison was performed using an appropriate contrast.||-28.2|-47.5|<0.0001
72505423|NCT03461965|144541825|OTHER|p-value \< 0.05 was considered statistically significant||||||0.352|||||||t-test, 2 sided|paired t-test||Comparing change in scores (post-stage minus baseline) between experimental and control groups||||0.352
72505424|NCT03461965|144541826|OTHER|p-value \< 0.05 was considered statistically significant|||||<|0.0001|||||||t-test, 2 sided|||Difference of pre (baseline) and post-test scores within each treatment group||||<0.0001
72505425|NCT03461965|144541826|OTHER|p-value \< 0.05 was considered statistically significant||||||0.04|||||||t-test, 2 sided|||Difference of pre (baseline) and post-test scores within each treatment group||||0.04
72505426|NCT03461965|144541826|OTHER|p-value \< 0.05 was considered statistically significant||||||0.052|||||||t-test, 2 sided|paired t-test||Comparing change in scores (post-stage minus baseline) between experimental and control groups||||0.052
72505427|NCT03461965|144541827|OTHER|p-value \< 0.05 was considered statistically significant|||||<|0.0001|||||||t-test, 2 sided|||Difference of pre (baseline) and post-test scores within each treatment group||||<0.0001
72505428|NCT03461965|144541827|OTHER|p-value \< 0.05 was considered statistically significant|||||<|0.0001|||||||t-test, 2 sided|||Difference of pre (baseline) and post-test scores within each treatment group||||<0.0001
72505429|NCT03461965|144541827|OTHER|p-value \< 0.05 was considered statistically significant||||||0.208|||||||t-test, 2 sided|paired t-test||Comparing change in scores (post-stage minus baseline) between experimental and control groups||||0.208
72505430|NCT03461965|144541828|OTHER|p-value \< 0.05 was considered statistically significant|||||<|0.03|||||||Chi-squared|||||||<0.03
72505431|NCT01863758|144541834|SUPERIORITY_OR_OTHER||Annualized number of bleeding episodes|3.13|||<|0.05|TWO_SIDED|95.0|2.56|3.8|||2-sided, 1-sample Poisson test||The annualized number of bleeding episodes in study GENA-01 was 49.36.|This study was considered as showing efficacy if the annualized number of bleeding episodes (BE) was reduced by 50% compared to the number of BEs observed in study GENA-01 (NCT00989196).||3.80|2.56|<0.05
72542421|NCT00272961|144614638|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.47|STANDARD_ERROR_OF_MEAN|4.56||0.5936|TWO_SIDED|95.0|-11.86|6.93|||ANCOVA|||Week 10 Sitting: p-value was obtained using an ANCOVA model on the post-dose minus pre-dose difference at Week 10 with the post-dose minus pre-dose difference at Baseline as a covariate.||6.93|-11.86|0.5936
72395347|NCT03510884|144297290|SUPERIORITY|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the considered dosing regimen).|LS mean difference|-30.7|STANDARD_ERROR_OF_MEAN|4.9|<|0.0001|TWO_SIDED|97.5|-42.0|-19.4||Threshold for significance at 0.025 level.|MMRM||Alirocumab Q4W versus Placebo Q4W|The MMRM model included the fixed categorical effects of treatment group (alirocumab, placebo), randomization strata (Baseline BW \[\<50 or \>=50 kg\]) as per IVRS, time point, treatment-by-time point interaction, and BW strata-by-time point interaction, as well as the continuous fixed covariates of Baseline Apo B value and Baseline Apo B value by time-point interaction. Comparison was performed using an appropriate contrast.||-19.4|-42.0|<0.0001
72395348|NCT03510884|144297291|SUPERIORITY|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the considered dosing regimen).|LS mean difference|-40.7|STANDARD_ERROR_OF_MEAN|5.0|<|0.0001|TWO_SIDED|97.5|-52.2|-29.1||Threshold for significance at 0.025 level.|MMRM||Alirocumab Q2W versus Placebo Q2W|The MMRM model included the fixed categorical effects of treatment group (alirocumab, placebo), randomization strata (previous participation \[yes or no\] to DFI14223 study, Baseline BW \[\<50 or \>=50 kg\]) as per IVRS, time point, treatment-by-time point interaction, strata-by-time point interaction, as well as the continuous fixed covariates of Baseline non-HDL-C value and Baseline non-HDL-C value by time-point interaction. Comparison was performed using an appropriate contrast.||-29.1|-52.2|<0.0001
72395349|NCT03510884|144297291|SUPERIORITY|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the considered dosing regimen).|LS mean difference|-31.9|STANDARD_ERROR_OF_MEAN|5.3|<|0.0001|TWO_SIDED|97.5|-44.1|-19.7||Threshold for significance at 0.025 level.|MMRM||Alirocumab Q4W versus Placebo Q4W|The MMRM model included the fixed categorical effects of treatment group (alirocumab, placebo), randomization strata (Baseline BW \[\<50 or \>=50 kg\]) as per IVRS, time point, treatment-by-time point interaction, and BW strata-by-time point interaction, as well as the continuous fixed covariates of Baseline non-HDL-C value and Baseline non-HDL-C value by time-point interaction. Comparison was performed using an appropriate contrast.||-19.7|-44.1|<0.0001
72395350|NCT03510884|144297292|SUPERIORITY|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the considered dosing regimen).|LS mean difference|-30.8|STANDARD_ERROR_OF_MEAN|3.9|<|0.0001|TWO_SIDED|97.5|-39.8|-21.9||Threshold for significance at 0.025 level.|MMRM||Alirocumab Q2W versus Placebo Q2W|The MMRM model included the fixed categorical effects of treatment group (alirocumab, placebo), randomization strata (previous participation \[yes or no\] to DFI14223 study, Baseline BW \[\<50 or \>=50 kg\]) as per IVRS, time point, treatment-by-time point interaction, strata-by-time point interaction, as well as the continuous fixed covariates of Baseline Total-C value and Baseline Total-C value by time-point interaction. Comparison was performed using an appropriate contrast.||-21.9|-39.8|<0.0001
72395351|NCT03510884|144297292|SUPERIORITY|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the considered dosing regimen).|LS mean difference|-23.3|STANDARD_ERROR_OF_MEAN|4.4|<|0.0001|TWO_SIDED|97.5|-33.5|-13.1||Threshold for significance at 0.025 level.|MMRM||Alirocumab Q4W versus Placebo Q4W|The MMRM model included the fixed categorical effects of treatment group (alirocumab, placebo), randomization strata (Baseline BW \[\<50 or \>=50 kg\]) as per IVRS, time point, treatment-by-time point interaction, and BW strata-by-time point interaction, as well as the continuous fixed covariates of Baseline Total-C value and Baseline Total-C value by time-point interaction. Comparison was performed using an appropriate contrast.||-13.1|-33.5|<0.0001
72395352|NCT03510884|144297293|SUPERIORITY|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the considered dosing regimen).|LS mean difference|-38.9|STANDARD_ERROR_OF_MEAN|4.0|<|0.0001|TWO_SIDED|97.5|-48.2|-29.6||Threshold for significance at 0.025 level.|MMRM||Alirocumab Q2W versus Placebo Q2W|The MMRM model included the fixed categorical effects of treatment group (alirocumab, placebo), randomization strata (previous participation \[yes or no\] to DFI14223 study, Baseline BW \[\<50 or \>=50 kg\]) as per IVRS, time point, treatment-by-time point interaction, strata-by-time point interaction, as well as the continuous fixed covariates of Baseline Apo B value and Baseline Apo B value by time-point interaction. Comparison was performed using an appropriate contrast.||-29.6|-48.2|<0.0001
72395353|NCT03510884|144297293|SUPERIORITY|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the considered dosing regimen).|LS mean difference|-32.8|STANDARD_ERROR_OF_MEAN|4.3|<|0.0001|TWO_SIDED|97.5|-42.8|-22.7|||MMRM||Alirocumab Q4W versus Placebo Q4W|The MMRM model included the fixed categorical effects of treatment group (alirocumab, placebo), randomization strata (Baseline BW \[\<50 or \>=50 kg\]) as per IVRS, time point, treatment-by-time point interaction, and BW strata-by-time point interaction, as well as the continuous fixed covariates of Baseline Apo B value and Baseline Apo B value by time-point interaction. Comparison was performed using an appropriate contrast.||-22.7|-42.8|<0.0001
72470984|NCT01055704|144465420|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.971|STANDARD_ERROR_OF_MEAN|4.669||0.675|TWO_SIDED|95.0|-11.415|7.472|||ANCOVA|Error degrees of freedom adjusted for number of missing values imputed.||Data were analyzed using analysis of covariance (ANCOVA) with gender and/or BMI included as covariates.||7.472|-11.415|0.675
72470985|NCT01055704|144465420|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.28|STANDARD_ERROR_OF_MEAN|4.208||0.591|TWO_SIDED|95.0|-10.792|6.233|||ANCOVA|Error degrees of freedom adjusted for number of missing values imputed.||Data were analyzed using analysis of covariance (ANCOVA) with gender and/or BMI included as covariates.||6.233|-10.792|0.591
72565607|NCT02709486|144662686|SUPERIORITY||Least Square Mean Difference|-0.43|STANDARD_ERROR_OF_MEAN|0.14||0.0014|TWO_SIDED|95.0|-0.7|-0.17|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariates, and study site as a random effect.||-0.17|-0.70|0.0014
72576674|NCT00094861|144680139|SUPERIORITY_OR_OTHER||Chi-Square Statistic|3.4812||||0.0621|TWO_SIDED|||||Generalized Cochran-Mantel-Haenszel (CMH) test for mean score difference using modified ridit score. Participants without any ECOG assessment post baseline were assumed to have ECOG status of 5 in the CMH test.|Cochran-Mantel-Haenszel|Stratified by disease stage, ECOG performance status, and estimated weight loss in the 3 months before study randomization.||||||0.0621
72395354|NCT03510884|144297294|SUPERIORITY|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the considered dosing regimen).|LS mean difference|-42.8|STANDARD_ERROR_OF_MEAN|4.7|<|0.0001|TWO_SIDED|97.5|-53.8|-31.8||Threshold for significance at 0.025 level.|MMRM||Alirocumab Q2W versus Placebo Q2W|The MMRM model included the fixed categorical effects of treatment group (alirocumab, placebo), randomization strata (previous participation \[yes or no\] to DFI14223 study, Baseline BW \[\<50 or \>=50 kg\]) as per IVRS, time point, treatment-by-time point interaction, strata-by-time point interaction, as well as the continuous fixed covariates of Baseline Non-HDL-C value and Baseline Non-HDL-C value by time-point interaction. Comparison was performed using an appropriate contrast.||-31.8|-53.8|<0.0001
72395355|NCT03510884|144297294|SUPERIORITY|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the considered dosing regimen).|LS mean difference|-37.5|STANDARD_ERROR_OF_MEAN|4.5|<|0.0001|TWO_SIDED|97.5|-47.9|-27.0||Threshold for significance at 0.025 level.|MMRM||Alirocumab Q4W versus Placebo Q4W|The MMRM model included the fixed categorical effects of treatment group (alirocumab, placebo), randomization strata (Baseline BW \[\<50 or \>=50 kg\]) as per IVRS, time point, treatment-by-time point interaction, and BW strata-by-time point interaction, as well as the continuous fixed covariates of Baseline non-HDL-C value and Baseline non-HDL-C value by time-point interaction. Comparison was performed using an appropriate contrast.||-27.0|-47.9|<0.0001
72395356|NCT03510884|144297295|SUPERIORITY|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the considered dosing regimen).|LS mean difference|-32.7|STANDARD_ERROR_OF_MEAN|3.7|<|0.0001|TWO_SIDED|97.5|-41.3|-24.2||Threshold for significance at 0.025 level.|MMRM||Alirocumab Q2W versus Placebo Q2W|The MMRM model included the fixed categorical effects of treatment group (alirocumab, placebo), randomization strata (previous participation \[yes or no\] to DFI14223 study, Baseline BW \[\<50 or \>=50 kg\]) as per IVRS, time point, treatment-by-time point interaction, strata-by-time point interaction, as well as the continuous fixed covariates of Baseline Total-C value and Baseline Total-C value by time-point interaction. Comparison was performed using an appropriate contrast.||-24.2|-41.3|<0.0001
72395357|NCT03510884|144297295|SUPERIORITY|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the considered dosing regimen).|LS mean difference|-27.9|STANDARD_ERROR_OF_MEAN|3.4|<|0.0001|TWO_SIDED|97.5|-35.6|-20.2||Threshold for significance at 0.025 level.|MMRM||Alirocumab Q4W versus Placebo Q4W|The MMRM model included the fixed categorical effects of treatment group (alirocumab, placebo), randomization strata (Baseline BW \[\<50 or \>=50 kg\]) as per IVRS, time point, treatment-by-time point interaction, and BW strata-by-time point interaction, as well as the continuous fixed covariates of Baseline Total-C value and Baseline Total-C value by time-point interaction. Comparison was performed using an appropriate contrast.||-20.2|-35.6|<0.0001
72395358|NCT03510884|144297296|SUPERIORITY|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the considered dosing regimen).|Odds Ratio (OR)|77.6|||=|0.0001|TWO_SIDED|97.5|6.3|960.0||Threshold for significance at 0.025 level.|Regression, Logistic||Alirocumab Q2W versus Placebo Q2W: Combined estimate for odds ratio was obtained by combining the logarithm of odds ratio from logistic regression model analyses of the different imputed data sets, using Rubin's formulae.|Multiple imputation approach followed by logistic regression model. Logistic regression model stratified by randomization factors (previous participation \[yes or no\] to DFI14223 study, Baseline BW \[\<50 or \>=50 kg\]) as per IVRS included the fixed categorical effect of treatment group and the continuous fixed covariate of Baseline LDL-C value.||960.0|6.3|=0.0001
72395359|NCT03510884|144297296|SUPERIORITY|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the considered dosing regimen).|Odds Ratio (OR)|14.9|||<|0.0001|TWO_SIDED|97.5|3.2|69.8||Threshold for significance at 0.025 level.|Regression, Logistic||Alirocumab Q4W versus Placebo Q4W: Combined estimate for odds ratio was obtained by combining the logarithm of odds ratio from logistic regression model analyses of the different imputed data sets, using Rubin's formulae.|Multiple imputation approach followed by logistic regression model. Logistic regression model stratified by randomization factors (Baseline BW \[\<50 or \>=50 kg\]) as per IVRS included the fixed categorical effect of treatment group and the continuous fixed covariate of Baseline LDL-C value.||69.8|3.2|<0.0001
72395360|NCT03510884|144297297|SUPERIORITY|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the considered dosing regimen).|Odds Ratio (OR)|26.5|||<|0.0001|TWO_SIDED|97.5|4.0|174.8||Threshold for significance at 0.025 level.|Regression, Logistic||Alirocumab Q2W versus Placebo Q2W: Combined estimate for odds ratio was obtained by combining the logarithm of odds ratio from logistic regression model analyses of the different imputed data sets, using Rubin's formulae.|Multiple imputation approach followed by logistic regression model. The logistic regression model stratified by randomization factors (previous participation \[yes or no\] to DFI14223 study, Baseline BW \[\<50 or \>=50 kg\]) as per IVRS included the fixed categorical effect of treatment group and the continuous fixed covariate of Baseline LDL-C value.||174.8|4.0|<0.0001
72395361|NCT03510884|144297297|SUPERIORITY|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the considered dosing regimen).|Odds Ratio (OR)|40.9|||<|0.0001|TWO_SIDED|97.5|5.7|290.9||Threshold for significance at 0.025 level.|Regression, Logistic||Alirocumab Q4W versus Placebo Q4W: Combined estimate for odds ratio was obtained by combining the logarithm of odds ratio from logistic regression model analyses of the different imputed data sets, using Rubin's formulae.|Multiple imputation approach followed by logistic regression model. The logistic regression model stratified by randomization factors (Baseline BW \[\<50 or \>=50 kg\]) as per IVRS included the fixed categorical effect of treatment group and the continuous fixed covariate of Baseline LDL-C value.||290.9|5.7|<0.0001
72470986|NCT01055704|144465421|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-34.425|STANDARD_ERROR_OF_MEAN|14.67||0.024|TWO_SIDED|95.0|-64.097|-4.753|||ANCOVA|Error degrees of freedom adjusted for number of missing values imputed.||Data were analyzed using analysis of covariance (ANCOVA) with gender and/or BMI included as covariates.||-4.753|-64.097|0.024
72470987|NCT01055704|144465421|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.181|STANDARD_ERROR_OF_MEAN|13.24||0.989|TWO_SIDED|95.0|-26.962|26.598|||ANCOVA|Error degrees of freedom adjusted for number of missing values imputed.||Data were analyzed using analysis of covariance (ANCOVA) with gender and/or BMI included as covariates.||26.598|-26.962|0.989
72622691|NCT05273437|144775491|OTHER|We conducted a Bayesian Regression for all available participants, then visualized the results. (N x 16 table, N: number of participants).|Credibility interval|80.0|||||TWO_SIDED||||||Bayesian Regression|We explicitly sought 80% credibility of at least 100 steps more within the 3-hour increment in comparison to the intervention.|We decided that 100 steps/3 hours is the minimum value of the MAP intervention effect estimate and that an INUS condition is valid only if there is at least an 80% chance of achieving an effect beyond 100 steps/3 hours.|We hypothesized that some individuals have their own time and decision-policy-specific response pattern regardless of day elapsed since the beginning of the intervention. We did not hypothesize the direction of the effect variation.|The decision point was the unit of analysis. For the Bayesian Regression, we used Markov Chain Monte Carlo (MCMC). Four sampling chains were used when performing Bayesian modeling. The number of estimation samples and target acceptance rate were gradually increased until numerical stability was achieved. The number of estimation samples was increased by multiplied by 2, as advised by previous literature, depending on the ratio of convergence diagnostics R̂ \> 1.1. We used 100 steps increase during 3 hours as the effect threshold value. We assumed that there is an effect only if the estimated effect is more than 80% probable (i.e., the credibility interval is over 100 steps/3 hours) and the Maximum A Posteriori Point (MAP) of the effect is more than 100 steps/3 hours. Otherwise, there is no effect. Among the models with effects, we clipped to 1000 steps/3hours as a maximum if the MAP was greater than 1000 steps/3 hours.|||
72622692|NCT01916226|144775500|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|-0.3||0.278|TWO_SIDED|95.0|-0.7|0.2||Estimating the standard deviation of CFB in rTNSS over 2 weeks to be approximately 2.6, a two-sample t-test with α=0.05 suggests that a sample size of 144 participants per arm would provide 90% power to show a difference of 1.0 between treatments.|ANCOVA|||||0.2|-0.7|0.278
72622693|NCT03163667|144775507|SUPERIORITY||Hazard Ratio (HR)|0.64||||0.07905|TWO_SIDED|95.0|0.34|1.2||One-sided p-value comparing the treatment groups was based on a stratified log-rank test with alternative hypothesis of survival functions being not equal.|Log Rank||Hazard ratio comparing treatment groups (experimental over control) is based on a Cox proportional hazards model. A hazard ratio \< 1 favors CB-839+Everolimus (CBE), and a hazard ratio \> 1 favors Placebo+Everolimus (PboE).|Stratified analysis. Stratification factors were Memorial Sloan Kettering Cancer Center (MSKCC) Prognostic Risk (favorable versus intermediate/poor risk) and number of prior therapies with a tyrosine kinase inhibitor (TKI; 1 versus \> 1). Due to stratification cells having \< 10 events, TKI stratification factor was removed for analysis.||1.20|0.34|0.07905
72622694|NCT03163667|144775507|SUPERIORITY||Hazard Ratio (HR)|0.69||||0.1184|TWO_SIDED|95.0|0.37|1.28||One-sided p-value comparing the treatment groups was based on an unstratified log-rank test with alternative hypothesis of survival functions being not equal.|Log Rank||Hazard ratio comparing treatment groups (experimental over control) is based on a Cox proportional hazards model. A hazard ratio \< 1 favors CBE, and a hazard ratio \> 1 favors PboE.|Unstratified analysis||1.28|0.37|0.1184
72622695|NCT03163667|144775508|SUPERIORITY||Hazard Ratio (HR)|0.8||||0.4801|TWO_SIDED|95.0|0.42|1.5||P-value comparing the treatment groups is based on a stratified log-rank test with alternative hypothesis of survival functions being not equal.|Log Rank||Hazard ratio based on a Cox proportional hazards model. A hazard ratio \< 1 favors CBE, and a hazard ratio \> 1 favors PboE.|Stratified analysis: Stratification factors are MSKCC Prognostic Risk (favorable vs intermediate/poor risk) and number of prior therapies with a TKI (1 vs \> 1). Due to stratification cells having \< 10 events, TKI stratification factor was removed for analysis.||1.50|0.42|0.4801
72622696|NCT03163667|144775508|SUPERIORITY||Hazard Ratio (HR)|0.83||||0.5603|TWO_SIDED|95.0|0.44|1.56||P-value comparing the treatment groups is based on an unstratified log-rank test with alternative hypothesis of survival functions being not equal.|Log Rank||Hazard ratio comparing treatment groups (experimental over control) is based on a Cox proportional hazards model. A hazard ratio \< 1 favors CBE, and a hazard ratio \> 1 favors PboE.|Unstratified analysis||1.56|0.44|0.5603
72622697|NCT04910165|144775509|SUPERIORITY||||||<|0.05||||||p-values reported are calculated by the listed statistical test.|Wilcoxon (Mann-Whitney)|||||||<0.05
72622698|NCT04910165|144775510|SUPERIORITY||||||<|0.05||||||p-values reported are calculated by the listed statistical test.|Wilcoxon (Mann-Whitney)|||||||<0.05
72622699|NCT04910165|144775511|SUPERIORITY||||||<|0.05||||||p-values reported are calculated by the listed statistical test.|Wilcoxon (Mann-Whitney)|||||||<0.05
72622700|NCT04910165|144775512|SUPERIORITY||||||<|0.05||||||p-values reported are calculated by the listed statistical test.|Wilcoxon (Mann-Whitney)|||||||<0.05
72395362|NCT03510884|144297298|SUPERIORITY|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the considered dosing regimen).|Odds Ratio (OR)|52.7|||=|0.0011|TWO_SIDED|97.5|3.5|804.3||Threshold for significance at 0.025 level.|Regression, Logistic||Alirocumab Q2W versus Placebo Q2W: Combined estimate for odds ratio was obtained by combining the logarithm of odds ratio from logistic regression model analyses of the different imputed data sets, using Rubin's formulae.|Multiple imputation approach followed by logistic regression model. The logistic regression model stratified by randomization factors (previous participation \[yes or no\] to DFI14223 study, Baseline BW \[\<50 or \>=50 kg\]) as per IVRS included the fixed categorical effect of treatment group and the continuous fixed covariate of Baseline LDL-C value.||804.3|3.5|=0.0011
72470988|NCT01055704|144465422|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.401|STANDARD_ERROR_OF_MEAN|0.211||0.064|TWO_SIDED|95.0|-0.827|0.025|||ANCOVA|Error degrees of freedom adjusted for number of missing values imputed.||Data were analyzed using analysis of covariance (ANCOVA) with gender and/or BMI included as covariates.||0.025|-0.827|0.064
72470989|NCT01055704|144465422|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.098|STANDARD_ERROR_OF_MEAN|0.19||0.61|TWO_SIDED|95.0|-0.287|0.482|||ANCOVA|Error degrees of freedom adjusted for number of missing values imputed.||Data were analyzed using analysis of covariance (ANCOVA) with gender and/or BMI included as covariates.||0.482|-0.287|0.610
72622701|NCT04910165|144775513|SUPERIORITY||||||<|0.05||||||p-values reported are calculated by the listed statistical test.|Wilcoxon (Mann-Whitney)|||||||<0.05
72622702|NCT04910165|144775514|SUPERIORITY||||||<|0.05||||||p-values reported are calculated by the listed statistical test.|Fisher Exact|||||||<0.05
72622703|NCT04910165|144775515|SUPERIORITY||||||<|0.05||||||p-values reported are calculated by the listed statistical test.|Fisher Exact|||||||<0.05
72622704|NCT02528305|144775542|SUPERIORITY_OR_OTHER|||||||0.474|||||||ANOVA|||||||0.474
72622705|NCT02528305|144775543|SUPERIORITY_OR_OTHER|||||||0.174|||||||ANOVA|||||||0.174
72622706|NCT02528305|144775544|SUPERIORITY_OR_OTHER|||||||0.303|||||||ANOVA|||||||0.303
72622707|NCT02528305|144775545|SUPERIORITY|||||||0.023|||||||ANOVA|||||||0.023
72505432|NCT01863758|144541835|SUPERIORITY_OR_OTHER||Annualized number of spontaneous BEs|1.9|||<|0.05|TWO_SIDED|95.0|1.46|2.43|||2-sided, 1-sample Poisson test||The annualized number of spontaneous bleeding episodes in study GENA-01 was 32.23|This study was considered as showing efficacy if the annualized number of spontaneous bleeding episodes (BE) was reduced by 50% compared to the number of spontaneous BEs observed in study GENA-01 (NCT00989196).||2.43|1.46|<0.05
72505433|NCT00969618|144541903|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for total ADHD symptoms score.|Paired t-test|||||||<0.001
72505434|NCT00969618|144541903|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for inattention subscale score.|Paired t-test|||||||<0.001
72505435|NCT00969618|144541903|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for hyperactivity/impulsivity subscale score.|Paired t-test|||||||<0.001
72505436|NCT00969618|144541903|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for ADHD index subscale score.|Paired t-test|||||||<0.001
72505437|NCT00969618|144541904|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Paired t-test|||||||<0.001
72505438|NCT00969618|144541905|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is GEC subscale score.|Paired t-test|||||||<0.001
72505439|NCT00969618|144541905|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for behavioral regulation subscale score.|Paired t-test|||||||<0.001
72505440|NCT00969618|144541905|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for metacognition subscale score.|Paired t-test|||||||<0.001
72505441|NCT00969618|144541906|SUPERIORITY_OR_OTHER|||||||0.2||95.0|||||Paired t-test|||||||0.200
72505442|NCT00969618|144541907|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Paired t-test|||||||<0.001
72505443|NCT00969618|144541908|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for GEC subscale score.|Paired t-test|||||||<0.001
72505444|NCT00969618|144541908|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for behavioral regulation subscale score.|Paired t-test|||||||<0.001
72505445|NCT00969618|144541908|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for metacognition subscale score.|Paired t-test|||||||<0.001
72505446|NCT00969618|144541909|SUPERIORITY_OR_OTHER|||||||0.384||95.0|||||Paired t-test|||||||0.384
72505447|NCT05136885|144541910|SUPERIORITY||Disease Rate Ratio|0.87|STANDARD_DEVIATION|0.111|||TWO_SIDED|95.0|0.665|1.102||Posterior probability that the disease rate ratio (DRR) is less than 1 (i.e. (Trehalose) slowed progression) was (0.8772). NOTE: p-value is not provided for Bayesian model.|Bayesian shared-parameter model|A Bayesian shared-parameter model of change in disease severity as measured by ALSFRS-R total score and mortality.|"DDR \<1 imply slowing of disease progression by Trehalose relative to placebo.Note: reported Confidence Interval is actually a Bayesian credible interval."||The DRR parameter for active treatment represents the relative change to the rate of decline of ALSFRS-R and the rate of mortality of treated participant relative to a placebo participant. The estimated DRR can also be interpreted as the average rate of decline in function and mortality. The model includes covariates for baseline use of edaravone, baseline use of riluzole, baseline use of Relyvrio, months since onset of symptoms, and pre-baseline slope of ALSFRS-R, serum NfL concentration and random effects for regimen and participant-specific slopes.|1.102|0.665|
72505448|NCT05136885|144541912|SUPERIORITY||Mean Difference (Net)|-0.55|STANDARD_ERROR_OF_MEAN|1.79||0.7607|TWO_SIDED|95.0|-4.06|2.97|||Mixed Models Analysis|Covariates include baseline use of edaravone and riluzole, months since symptom onset, pre-baseline ALSFRS-R slope, and baseline log-transformed NfL.|Trehalose 24-week change from baseline relative to placebo 24-week change from baseline.|||2.97|-4.06|0.7607
72505449|NCT05136885|144541913|SUPERIORITY||Mean Difference (Net)|0.92|STANDARD_ERROR_OF_MEAN|3.204||0.7737|TWO_SIDED|95.0|-5.37|7.21|||Mixed Models Analysis|Covariates include baseline use of edaravone and riluzole, months since symptom onset, pre-baseline ALSFRS-R slope, and baseline log-transformed NfL.|Trehalose 24-week change from baseline relative to placebo 24-week change from baseline.|||7.21|-5.37|0.7737
72505450|NCT05136885|144541914|SUPERIORITY|||||||0.2137|||||||Log Rank|||||||0.2137
72505451|NCT03270085|144541951|SUPERIORITY|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||||||0.001
72505452|NCT03270085|144541952|SUPERIORITY|||||||0.81|||||||Wilcoxon (Mann-Whitney)|||||||0.81
72505453|NCT03270085|144541953|SUPERIORITY|||||||0.91|||||||Wilcoxon (Mann-Whitney)|||||||0.91
72505454|NCT02340104|144541955|EQUIVALENCE|Geometric Least Square (LS) Means values were calculated using Log pharmacokinetic (PK) model with treatment, participant, random error as model with treatment as a fixed effect and participant and error as random effects.|Ratio of Geometric LS Means|0.789|||||TWO_SIDED|90.0|0.769|0.81|||||Geometric Least Square (LS) Means values were calculated using Log pharmacokinetic (PK) model with treatment, participant, random error as independent variables, where participant was fitted as a random effect.|||0.810|0.769|
72505455|NCT01269125|144541956|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.28|STANDARD_ERROR_OF_MEAN|0.0||0.8|TWO_SIDED|95.0|-0.2|0.3|||Chi-squared|||||0.3|-0.2|0.80
72505456|NCT01269125|144541960|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.05|STANDARD_ERROR_OF_MEAN|0.0||0.8||95.0|-0.2|0.3|||Chi-squared|||||0.3|-0.2|0.80
72505457|NCT01269125|144541960|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|-0.1|STANDARD_ERROR_OF_MEAN|0.0||0.48||95.0|-0.4|0.2|||Chi-squared|||In order to handle the problem of small sample size combined with the inability to identify the theoretical statistical distribution of data, bootstrap techniques are used (10). Ader and co-workers recommend the bootstrap procedure when (a) the theoretical distribution is complicated or unknown, and/or (b) power calculations have to be performed and a small sample is available (11). Finally, the bootstrap distribution has been used in order to calculate all the confidence intervals.||0.2|-0.4|0.48
72622708|NCT02528305|144775546|SUPERIORITY_OR_OTHER|||||||0.092|||||||ANOVA|For the analysis of Total body fat||||||0.092
72622709|NCT02528305|144775546|SUPERIORITY_OR_OTHER|||||||0.101|||||||ANOVA|For the analysis of Trunk fat||||||0.101
72622710|NCT02528305|144775547|SUPERIORITY_OR_OTHER|||||||0.771|||||||ANOVA|For the analysis of systolic blood pressure||||||0.771
72622711|NCT02528305|144775547|SUPERIORITY_OR_OTHER|||||||0.028|||||||ANOVA|For the analysis of diastolic blood pressure||||||0.028
72622712|NCT02528305|144775548|SUPERIORITY_OR_OTHER|||||||0.099|||||||ANOVA|For the analysis of Physical Function||||||0.099
72622713|NCT02528305|144775548|SUPERIORITY_OR_OTHER|||||||0.566|||||||ANOVA|For the analysis of Social Function||||||0.566
72622714|NCT02528305|144775548|SUPERIORITY_OR_OTHER|||||||0.246|||||||ANOVA|For the analysis of Mental Health||||||0.246
72395363|NCT03510884|144297298|SUPERIORITY|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the considered dosing regimen).|Odds Ratio (OR)|43.1|||=|0.0006|TWO_SIDED|97.5|3.7|498.6||Threshold for significance at 0.025 level.|Regression, Logistic||Alirocumab Q4W versus Placebo Q4W: Combined estimate for odds ratio was obtained by combining the logarithm of odds ratio from logistic regression model analyses of the different imputed data sets, using Rubin's formulae.|Multiple imputation approach followed by logistic regression model. The logistic regression model stratified by randomization factors (Baseline BW \[\<50 or \>=50 kg\]) as per IVRS included the fixed categorical effect of treatment group and the continuous fixed covariate of Baseline LDL-C value.||498.6|3.7|=0.0006
72395364|NCT03510884|144297299|SUPERIORITY|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the considered dosing regimen).|Odds Ratio (OR)|41.3|||<|0.0001|TWO_SIDED|97.5|6.6||The percentage of participants reaching LDL-C level lower than 110 mg/dL was 0% in the placebo arm, as a result it was possible to derive the estimated odds-ratio, but the estimated confidence interval (CI) was very wide, with the upper limit estimated to Infinity, therefore upper limit of 97.5% CI was not available to report.|Threshold for significance at 0.025 level.|Exact conditional logistic regression||Alirocumab Q2W versus Placebo Q2W: Odds ratios and confidence intervals estimated from exact conditional logistic regression model.|The LOCF approach followed by exact conditional logistic regression model. The exact conditional logistic regression model stratified by randomization factors (previous participation \[yes or no\] to DFI14223 study, Baseline BW \[\<50 or \>=50 kg\]) as per IVRS included the fixed categorical effect of treatment group and the quartiles of the Baseline LDL-C value.|||6.6|<0.0001
72395365|NCT03510884|144297299|SUPERIORITY|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the considered dosing regimen).|Odds Ratio (OR)|104.8|||=|0.0005|TWO_SIDED|97.5|5.2|2095.9||Threshold for significance at 0.025 level.|Regression, Logistic||Alirocumab Q4W versus Placebo Q4W: Combined estimate for odds ratio was obtained by combining the logarithm of odds ratio from logistic regression model analyses of the different imputed data sets, using Rubin's formulae.|Multiple imputation approach followed by logistic regression model. The logistic regression model stratified by randomization factors (Baseline BW \[\<50 or \>=50 kg\]) as per IVRS included the fixed categorical effect of treatment group and the continuous fixed covariate of Baseline LDL-C value.||2095.9|5.2|=0.0005
72395366|NCT03510884|144297300|SUPERIORITY|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the considered dosing regimen).|Adjusted mean difference|-15.2|STANDARD_ERROR_OF_MEAN|6.7|=|0.0237|TWO_SIDED|97.5|-30.3|-0.1||Threshold for significance at 0.025 level.|Robust regression model||Alirocumab Q2W versus Placebo Q2W|Multiple imputation approach followed by robust regression model. The robust regression model included the fixed categorical effect of treatment group and randomization strata (previous participation \[yes or no\] to DFI14223 study, Baseline BW \[\<50 or \>=50 kg\]) as per IVRS and the continuous fixed covariate of Baseline lipoprotein (a) value.||-0.1|-30.3|=0.0237
72395367|NCT03510884|144297300|SUPERIORITY|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the considered dosing regimen).|Adjusted mean difference|-24.9|STANDARD_ERROR_OF_MEAN|8.7|=|0.0043|TWO_SIDED|97.5|-44.4|-5.4||Threshold for significance at 0.025 level.|Robust regression model||Alirocumab Q4W versus Placebo Q4W|Multiple imputation approach followed by robust regression model. The robust regression model included the fixed categorical effect of treatment group and randomization strata (Baseline BW \[\<50 or \>=50 kg\]) as per IVRS and the continuous fixed covariate of Baseline lipoprotein (a) value.||-5.4|-44.4|=0.0043
72395368|NCT03510884|144297301|SUPERIORITY|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the considered dosing regimen).|Adjusted mean difference|-5.6|STANDARD_ERROR_OF_MEAN|7.1|=|0.4288|TWO_SIDED|97.5|-21.7|10.4||Threshold for significance at 0.025 level.|Robust regression model||Alirocumab Q2W versus Placebo Q2W|Multiple imputation approach followed by robust regression model. The robust regression model included the fixed categorical effect of treatment group and randomization strata (previous participation \[yes or no\] to DFI14223 study, Baseline BW \[\<50 or \>=50 kg\]) as per IVRS and the continuous fixed covariate of Baseline lipoprotein (a) value.||10.4|-21.7|=0.4288
72395369|NCT03510884|144297301|SUPERIORITY|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the considered dosing regimen).|Adjusted mean difference|-13.5|STANDARD_ERROR_OF_MEAN|8.6|=|0.1148|TWO_SIDED|97.5|-32.7|5.7||Threshold for significance at 0.025 level.|Robust regression model||Alirocumab Q4W versus Placebo Q4W|Multiple imputation approach followed by robust regression model. The robust regression model included the fixed categorical effect of treatment group and randomization strata (Baseline BW \[\<50 or \>=50 kg\]) as per IVRS and the continuous fixed covariate of Baseline lipoprotein (a) value.||5.7|-32.7|=0.1148
72395370|NCT00856284|144297331|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was met if the upper limit of the 1-sided 98.75% CI for the difference between alogliptin 25 mg and glipizide in HbA1c change from Baseline was less than 0.3%. If the null hypothesis H01 was rejected, then H02 was tested to show noninferiority of alogliptin 12.5 mg versus glipizide with a margin of 0.3%. Non-inferiority was met if the upper limit of the 1-sided 98.75% CI for the difference between alogliptin 12.5 mg and glipizide in HbA1c change from Baseline was less than 0.3%.|LS Mean Difference|-0.03|||||ONE_SIDED|98.75||0.059||||||The null hypotheses were tested in a fixed order at the 1-sided 0.0125 significance level at Weeks 52 and 104, independently: H01: Alogliptin 25 mg was inferior in HbA1c change from Baseline vs glipizide. H02: Alogliptin 12.5 mg was inferior vs glipizide. H03: Alogliptin 25 mg was not superior vs glipizide. H04: Alogliptin 12.5 mg was not superior vs glipizide. Each subsequent null hypothesis was tested only if all previously tested null hypotheses were rejected with respect to Weeks 52 and 104.||0.059||
72470990|NCT01055704|144465423|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.728|STANDARD_ERROR_OF_MEAN|0.497||0.151|TWO_SIDED|95.0|-0.278|1.734|||ANCOVA|Error degrees of freedom adjusted for number of missing values imputed.||Data were analyzed using analysis of covariance (ANCOVA) with gender and/or BMI included as covariates.||1.734|-0.278|0.151
72622715|NCT02528305|144775548|SUPERIORITY_OR_OTHER|||||||0.145|||||||ANOVA|For the analysis of Pain||||||0.145
72622716|NCT02528305|144775548|SUPERIORITY_OR_OTHER|||||||0.085|||||||ANOVA|For the analysis of Change in Health||||||0.085
72395371|NCT00856284|144297331|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was met if the upper limit of the 1-sided 98.75% CI for the difference between alogliptin 25 mg and glipizide in HbA1c change from Baseline was less than 0.3%. If the null hypothesis H01 was rejected, then H02 was tested to show noninferiority of alogliptin 12.5 mg versus glipizide with a margin of 0.3%. Non-inferiority was met if the upper limit of the 1-sided 98.75% CI for the difference between alogliptin 12.5 mg and glipizide in HbA1c change from Baseline was less than 0.3%.|LS Mean Difference|-0.09|||||ONE_SIDED|98.75||0.003||||||||0.003||
72395372|NCT00856284|144297337|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was met if the upper limit of the 1-sided 98.75% CI for the difference between alogliptin 25 mg and glipizide in HbA1c change from Baseline was less than 0.3%. If the null hypothesis H01 was rejected, then H02 was tested to show noninferiority of alogliptin 12.5 mg versus glipizide with a margin of 0.3%. Non-inferiority was met if the upper limit of the 1-sided 98.75% CI for the difference between alogliptin 12.5 mg and glipizide in HbA1c change from Baseline was less than 0.3%.|LS Mean Difference|-0.13|||||ONE_SIDED|98.75||-0.006||||||The null hypotheses were tested in a fixed order at the 1-sided 0.0125 significance level at Weeks 52 and 104, independently: H01: Alogliptin 25 mg was inferior in HbA1c change from Baseline vs glipizide. H02: Alogliptin 12.5 mg was inferior vs glipizide. H03: Alogliptin 25 mg was not superior vs glipizide. H04: Alogliptin 12.5 mg was not superior vs glipizide. Each subsequent null hypothesis was tested only if all previously tested null hypotheses were rejected with respect to Weeks 52 and 104.||-0.006||
72395373|NCT00856284|144297337|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was met if the upper limit of the 1-sided 98.75% CI for the difference between alogliptin 25 mg and glipizide in HbA1c change from Baseline was less than 0.3%. If the null hypothesis H01 was rejected, then H02 was tested to show noninferiority of alogliptin 12.5 mg versus glipizide with a margin of 0.3%. Non-inferiority was met if the upper limit of the 1-sided 98.75% CI for the difference between alogliptin 12.5 mg and glipizide in HbA1c change from Baseline was less than 0.3%.|LS Mean Difference|-0.09|||||ONE_SIDED|98.75||0.035||||||||0.035||
72395374|NCT02560584|144297338|SUPERIORITY||||||<|0.0001|||||||Exact one-sided test for a single propor|||"The proportion of patients with malignancy detected only with BLC with Cysview was to be analyzed using an exact one-sided test for a single proportion based on the cumulative binomial distribution with a significance level of 2.5%.~Null hypothesis: Malignancy is detected with BL only in 0.5% or less of the patients"||||<0.0001
72395375|NCT02560584|144297340|SUPERIORITY||||||<|0.0001|||||||Exact one-sided test for single proporti|||"The proportion of patients with one or more CIS lesions detected with BL and none with WL was to be evaluated using an exact binomial test for single proportion with a significance level of 2.5% (one-sided).~Null hypothesis: One or more CIS lesions are detected with BLC with Cysview and none with WL in less than or equal to 0.1% of the patients."||||<0.0001
72395376|NCT01391559|144297347|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|32.0||||0.17||95.0|||||t-test, 2 sided|||||||0.17
72395377|NCT00267046|144297348|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Fine and Gray method.|||||||<0.001
72395378|NCT01077856|144297386|SUPERIORITY_OR_OTHER_LEGACY||Standardized Prevalence Ratio (SPR)|1.34|||||TWO_SIDED|95.0|0.89|2.0|||||SPR is the age-adjusted ratio of percentage of live births with a major congenital anomaly (Women who received Gardasil / Women in the general population)|||2.00|0.89|
72395379|NCT01077856|144297386|SUPERIORITY_OR_OTHER_LEGACY||Standardized Prevalence Ratio (SPR)|1.59|||||TWO_SIDED|95.0|0.0|4.77|||||SPR is the age-adjusted ratio of percentage of live births with a major congenital anomaly (Women who received Gardasil / Women in the general population)|||4.77|0.00|
72395380|NCT01077856|144297386|SUPERIORITY_OR_OTHER_LEGACY||Standardized Prevalence Ratio (SPR)|0.86|||||TWO_SIDED|95.0|0.0|2.02|||||SPR is the age-adjusted ratio of percentage of live births with a major congenital anomaly (Women who received Gardasil / Women in the general population)|||2.02|0.00|
72395381|NCT03950167|144297391|OTHER||Mean Difference (Final Values)|0.85||||0.05|TWO_SIDED|||||A p value of \<0.05 was accepted as significant in all statistical analyses.|t-test, 2 sided||p value demonstrated above is the calculated value. Fasting CCK level difference: hyperemesis group-control group|||||0.05
72395382|NCT03950167|144297391|OTHER||Mean Difference (Net)|0.68||||0.05|TWO_SIDED||||||t-test, 2 sided||p value demonstrated above is the calculated value. Postprandial CCK level difference: hyperemesis group-control group|Since this is the first study comparing both CCK levels and GB functions in patients diagnosed with hyperemesis gravidarum (HG) and healthy pregnant women, a power analysis was not feasible.||||0.05
72395383|NCT03950167|144297392|OTHER||Mean Difference (Final Values)|0.91||||0.05|TWO_SIDED|||||A p value of \<0.05 was accepted as significant in all statistical analyses.|t-test, 2 sided||p value demonstrated above is the calculated value. Fasting GB wall thickness: Hyperemesis group-control group|||||0.05
72505458|NCT01269125|144541960|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|-0.15|STANDARD_ERROR_OF_MEAN|0.0||0.22||95.0|-0.4|0.1|||Chi-squared|||In order to handle the problem of small sample size combined with the inability to identify the theoretical statistical distribution of data, bootstrap techniques are used (10). Ader and co-workers recommend the bootstrap procedure when (a) the theoretical distribution is complicated or unknown, and/or (b) power calculations have to be performed and a small sample is available (11). Finally, the bootstrap distribution has been used in order to calculate all the confidence intervals.||0.1|-0.4|0.22
72395384|NCT03950167|144297392|OTHER||Mean Difference (Final Values)|0.23||||0.05|TWO_SIDED|||||A p value of \<0.05 was accepted as significant in all statistical analyses.|t-test, 2 sided||p value demonstrated above is the calculated value. Postprandial GB wall thickness: hyperemesis group-control group|||||0.05
72395385|NCT03950167|144297393|OTHER||Mean Difference (Final Values)|0.41||||0.05|TWO_SIDED|||||A p value of \<0.05 was accepted as significant in all statistical analyses.|t-test, 2 sided||p value demonstrated above is the calculated value. Fasting GB volume: hyperemesis group-control group|||||0.05
72395386|NCT03950167|144297393|OTHER||Mean Difference (Final Values)|0.71||||0.05|TWO_SIDED|||||A p value of \<0.05 was accepted as significant in all statistical analyses.|t-test, 2 sided||p value demonstrated above is the calculated value. Postprandial GB volume: hyperemesis group-control group|||||0.05
72395387|NCT03950167|144297394|OTHER||Mean Difference (Final Values)|0.22||||0.05|TWO_SIDED|||||A p value of \<0.05 was accepted as significant in all statistical analyses.|t-test, 2 sided||p value demonstrated above is the calculated value. Fasting GB ejection fraction: hyperemesis group-control group|||||0.05
72395388|NCT03950167|144297394|OTHER||Mean Difference (Final Values)|0.63||||0.05|TWO_SIDED|||||A p value of \<0.05 was accepted as significant in all statistical analyses.|t-test, 2 sided||p value demonstrated above is the calculated value. Postprandial GB ejection fraction: hyperemesis group-control group|||||0.05
72395389|NCT03247530|144297395|SUPERIORITY||Least Square Mean Difference|-5.8|STANDARD_ERROR_OF_MEAN|1.61||0.0004|TWO_SIDED|95.0|-8.9|-2.6|||Mixed Models for Repeated Measures|||||-2.6|-8.9|0.0004
72395390|NCT03247530|144297395|SUPERIORITY||Least Square Mean Difference|-6.9|STANDARD_ERROR_OF_MEAN|1.58|<|0.0001|TWO_SIDED|95.0|-10.0|-3.8|||Mixed Models for Repeated Measures|||||-3.8|-10.0|<0.0001
72395391|NCT03247530|144297396|SUPERIORITY||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.14||0.002|TWO_SIDED|95.0|-0.7|-0.2|||ANCOVA|ANCOVA model with baseline Clinical Global Impression-Severity of Illness (CGI-S) score and treatment as fixed independent variables.||||-0.2|-0.7|0.0020
72395392|NCT03247530|144297396|SUPERIORITY||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-0.8|-0.3|||ANCOVA|ANCOVA model with baseline Clinical Global Impression-Severity of Illness (CGI-S) score and treatment as fixed independent variables.||||-0.3|-0.8|<0.0001
72395393|NCT03247530|144297397|SUPERIORITY||Mean Difference (Final Values)|-4.2|STANDARD_ERROR_OF_MEAN|1.16||0.0003|TWO_SIDED|95.0|-6.5|-1.9|||ANCOVA|||||-1.9|-6.5|0.0003
72395394|NCT03247530|144297397|SUPERIORITY||Mean Difference (Final Values)|-4.3|STANDARD_ERROR_OF_MEAN|1.15||0.0002|TWO_SIDED|95.0|-6.6|-2.1|||ANCOVA|||||-2.1|-6.6|0.0002
72395395|NCT03247530|144297398|SUPERIORITY||Least Square Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.047||0.0019|TWO_SIDED|95.0|-0.24|-0.05|||ANCOVA|||||-0.05|-0.24|0.0019
72395396|NCT03247530|144297398|SUPERIORITY||Least Square Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.046||0.002|TWO_SIDED|95.0|-0.26|-0.08|||ANCOVA|||||-0.08|-0.26|0.0020
72395397|NCT03247530|144297399|SUPERIORITY||Risk Difference (RD)|14.5||||0.0063|TWO_SIDED|95.0|4.3|24.6|||Regression, Logistic|||||24.6|4.3|0.0063
72395398|NCT03247530|144297399|SUPERIORITY||Risk Difference (RD)|21.5|||<|0.0001|TWO_SIDED|95.0|11.3|31.6|||Regression, Logistic|||||31.6|11.3|<0.0001
72395399|NCT03247530|144297400|SUPERIORITY||Least Square Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|1.63||0.9974|TWO_SIDED|95.0|-4.5|4.5|||ANCOVA|||||4.5|-4.5|0.9974
72470991|NCT01055704|144465423|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.111|STANDARD_ERROR_OF_MEAN|0.448||0.806|TWO_SIDED|95.0|-0.795|1.017|||ANCOVA|Error degrees of freedom adjusted for number of missing values imputed.||Data were analyzed using analysis of covariance (ANCOVA) with gender and/or BMI included as covariates.||1.017|-0.795|0.806
72622717|NCT02528305|144775548|SUPERIORITY_OR_OTHER|||||||0.114|||||||ANOVA|For the analysis of Physical Role Limitation||||||0.114
72395400|NCT03247530|144297400|SUPERIORITY||Least Square Mean Difference|-1.7|STANDARD_ERROR_OF_MEAN|2.26||0.4557|TWO_SIDED|95.0|-6.1|2.7|||ANCOVA|||||2.7|-6.1|0.4557
72395401|NCT03247530|144297401|SUPERIORITY||Least Square Mean Difference|-2.9|STANDARD_ERROR_OF_MEAN|0.85||0.0006|TWO_SIDED|95.0|-4.6|-1.2|||ANCOVA|||This statistical analysis pertains to the Inattention subscale score||-1.2|-4.6|0.0006
72395402|NCT03247530|144297401|SUPERIORITY||Least Square Mean Difference|-3.5|STANDARD_ERROR_OF_MEAN|0.83|<|0.0001|TWO_SIDED|95.0|-5.2|-1.9|||ANCOVA|||This statistical analysis pertains to the Inattention subscale score||-1.9|-5.2|<0.0001
72395403|NCT03247530|144297401|SUPERIORITY||Least Square Mean Difference|-2.5|STANDARD_ERROR_OF_MEAN|0.83||0.0026|TWO_SIDED|95.0|-4.1|-0.9|||ANCOVA|||This analysis pertains to the Hyperactivity/Impulsivity subscale score||-0.9|-4.1|0.0026
72395404|NCT03247530|144297401|SUPERIORITY||Least Square Mean Difference|-3.2|STANDARD_ERROR_OF_MEAN|0.81|<|0.0001|TWO_SIDED|95.0|-4.8|-1.7|||ANCOVA|||This analysis pertains to the Hyperactivity/Impulsivity subscale score||-1.7|-4.8|<0.0001
72395405|NCT03247530|144297402|SUPERIORITY||Least Square Mean Difference|-1.8|STANDARD_ERROR_OF_MEAN|1.2||0.1292|TWO_SIDED|95.0|-4.2|0.5|||ANCOVA|||||0.5|-4.2|0.1292
72395406|NCT03247530|144297402|SUPERIORITY||Least Square Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|1.19||0.3447|TWO_SIDED|95.0|-3.4|1.2|||ANCOVA|||||1.2|-3.4|0.3447
72395407|NCT03247530|144297403|SUPERIORITY|||||||0.0005|||||||Chi-squared|||This analysis pertains to Week 1 of treatment||||0.0005
72395408|NCT03247530|144297403|SUPERIORITY|||||||0.0212|||||||Chi-squared|||This analysis pertains to Week 2 of treatment||||0.0212
72395409|NCT03247530|144297403|SUPERIORITY|||||||0.0115|||||||Chi-squared|||This analysis pertains to Week 3 of treatment||||0.0115
72395410|NCT03247530|144297403|SUPERIORITY|||||||0.0027|||||||Chi-squared|||This analysis pertains to Week 4 of treatment||||0.0027
72505459|NCT02773758|144541992|SUPERIORITY_OR_OTHER||Least square (LS) mean difference|-1.29|||<|0.0001|TWO_SIDED|95.0|-1.509|-1.071|||ANCOVA|From ANCOVA model with change from baseline in Schiff Sensitivity Score as response and treatment and baseline Schiff sensitivity score as covariates.|Difference is first named dentifrice minus second named dentifrice such that a negative difference favours first named dentifrice.|||-1.071|-1.509|<0.0001
72622718|NCT02528305|144775548|SUPERIORITY_OR_OTHER|||||||0.841|||||||ANOVA|For the analysis of Mental Role Limitation||||||0.841
72395411|NCT03247530|144297403|SUPERIORITY|||||||0.0066|||||||Chi-squared|||This analysis pertains to Week 5 of treatment||||0.0066
72395412|NCT03247530|144297403|SUPERIORITY|||||||0.0065|||||||Chi-squared|||This analysis pertains to Week 6 of treatment||||0.0065
72395413|NCT03247530|144297403|SUPERIORITY|||||||0.5826|||||||Chi-squared|||This analysis pertains to Week 1 of treatment||||0.5826
72395414|NCT03247530|144297403|SUPERIORITY|||||||0.0099|||||||Chi-squared|||This analysis pertains to Week 2 of treatment||||0.0099
72395415|NCT03247530|144297403|SUPERIORITY|||||||0.0225|||||||Chi-squared|||This analysis pertains to Week 3 of treatment||||0.0225
72395416|NCT03247530|144297403|SUPERIORITY|||||||0.0008|||||||Chi-squared|||This analysis pertains to Week 4 of treatment||||0.0008
72395417|NCT03247530|144297403|SUPERIORITY|||||||0.002|||||||Chi-squared|||This analysis pertains to Week 5 of treatment||||0.0020
72395418|NCT03247530|144297403|SUPERIORITY|||||||0.0002|||||||Chi-squared|||This analysis pertains to Week 6 of treatment||||0.0002
72395419|NCT01442493|144297405|SUPERIORITY|||||||0.92|||||||Mixed Models Analysis|||||||0.92
72395420|NCT01442493|144297406|SUPERIORITY|||||||0.06|||||||Mixed Models Analysis|||||||0.06
72395421|NCT01442493|144297407|SUPERIORITY|||||||0.08|||||||Mixed Models Analysis|||||||0.08
72395422|NCT01442493|144297408|SUPERIORITY|||||||0.54|||||||Mixed Models Analysis|||||||0.54
72395423|NCT01442493|144297409|SUPERIORITY|||||||0.04|||||||Mixed Models Analysis|||||||.04
72395424|NCT01442493|144297410|SUPERIORITY|||||||0.11|||||||Mixed Models Analysis|||||||0.11
72622719|NCT02528305|144775548|SUPERIORITY_OR_OTHER|||||||0.366|||||||ANOVA|For the analysis of Energy/Vitality||||||0.366
72395425|NCT01442493|144297411|SUPERIORITY|||||||0.21|||||||Mixed Models Analysis|||||||0.21
72395426|NCT02288559|144297418|SUPERIORITY||Difference in Adjusted Means|0.435||||0.0428|TWO_SIDED|80.0|0.162|0.707|||Mixed-Effect Model Repeated Measures|MMRM analysis variables: treatment group, visit, treatment-by-visit interaction, baseline GA area, and BCVA ETDRS chart Snellen equivalent category.||||0.707|0.162|0.0428
72395427|NCT02288559|144297418|SUPERIORITY||Difference in Adjusted Means|-0.21||||0.3361|TWO_SIDED|80.0|-0.491|0.071|||MMRM|MMRM analysis variables: treatment group, visit, treatment-by-visit interaction, baseline GA area, and BCVA ETDRS chart Snellen equivalent category.||||0.071|-0.491|0.3361
72395428|NCT01111149|144297424|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical Analysis for Serum Cotinine at Week 12||||>0.05
72395429|NCT01111149|144297424|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical Analysis for Serum Nicotine at Week 12||||>0.05
72470992|NCT01055704|144465424|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.772|STANDARD_ERROR_OF_MEAN|12.583||0.889|TWO_SIDED|95.0|-23.678|27.223|||ANCOVA|Error degrees of freedom adjusted for number of missing values imputed.||Data were analyzed using analysis of covariance (ANCOVA) with gender and/or BMI as covariates||27.223|-23.678|0.889
72470993|NCT01055704|144465424|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.607|STANDARD_ERROR_OF_MEAN|11.356||0.274|TWO_SIDED|95.0|-10.362|35.577|||ANCOVA|Error degrees of freedom adjusted for number of missing values imputed.||Data were analyzed using analysis of covariance (ANCOVA) with gender and/or BMI included as covariates.||35.577|-10.362|0.274
72470994|NCT01055704|144465425|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.214|STANDARD_ERROR_OF_MEAN|0.178||0.236|TWO_SIDED|95.0|-0.572|0.145|||ANCOVA|Error degrees of freedom adjusted for number of missing values imputed.||Data were analyzed using analysis of covariance (ANCOVA) with gender and/or BMI included as covariates.||0.145|-0.572|0.236
72470995|NCT01055704|144465425|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.028|STANDARD_ERROR_OF_MEAN|0.19||0.885|TWO_SIDED|95.0|-0.412|0.357|||ANCOVA|Error degrees of freedom adjusted for number of missing values imputed.||Data were analyzed using analysis of covariance (ANCOVA) with gender and/or BMI included as covariates.||0.357|-0.412|0.885
72470996|NCT01055704|144465426|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.497|STANDARD_ERROR_OF_MEAN|0.374||0.192|TWO_SIDED|95.0|-1.255|0.261|||ANCOVA|Error degrees of freedom adjusted for number of missing values imputed.||Data were analyzed using analysis of covariance (ANCOVA) with gender and/or BMI included as covariates.||0.261|-1.255|0.192
72470997|NCT01055704|144465426|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.063|STANDARD_ERROR_OF_MEAN|0.342||0.855|TWO_SIDED|95.0|-0.756|0.63|||ANCOVA|Error degrees of freedom adjusted for number of missing values imputed.||Data were analyzed using analysis of covariance (ANCOVA) with gender and/or BMI included as covariates.||0.630|-0.756|0.855
72470998|NCT01430468|144465440|EQUIVALENCE|With use of previously established criteria for a malpositioned glenoid, deviations of greater than 10 degrees of version from the planned placement were considered relevant.||||||0.11||||||P-value was calculated. Threshold for statistical significance (p\<0.05)|t-test, 2 sided|||The absolute difference between the actual outcome and the planned outcome was compared between the standard surgical group and the glenoid positioning system group with use of a Student t test. Results were considered to be significant at p \< 0.05.||||0.11
72395430|NCT01111149|144297424|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical Analysis for Urine Cotinine at Week 12||||>0.05
72395431|NCT01111149|144297424|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical Analysis for Urine Nicotine at Week 12||||>0.05
72395432|NCT01111149|144297425|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Chi-squared|||Statistical analysis for 50% Reduction in Number of Cigarettes Smoked (Week 12)||||>0.05
72395433|NCT01111149|144297425|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Chi-squared|||Statistical Analysis for 30% Reduction in Carbon Monoxide (Week 12)||||>0.05
72395434|NCT01111149|144297425|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Chi-squared|||Statistical Analysis for 30% Reduction in Serum Cotinine (Week 12)||||>0.05
72395435|NCT01111149|144297425|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Chi-squared|||Statistical Analysis for 30% Reduction in Urine Cotinine (Week 12)||||>0.05
72395436|NCT01111149|144297426|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical analysis for SANS Total Composite (Week 12)||||>0.05
72395437|NCT01111149|144297426|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical analysis for SANS Total Global (Week 12)||||>0.05
72470999|NCT03518567|144465462|SUPERIORITY||Slope|0.78||||4e-08|TWO_SIDED||||||Regression, Linear|"hits purchased on the MPT predicting hits actually purchased and smoked in the laboratory.~covariate: baseline total individual income"||||||.00000004
72471000|NCT03518567|144465463|SUPERIORITY||Mean Difference (Final Values)|-0.75|STANDARD_DEVIATION|1.09||9e-09|TWO_SIDED||||||t-test, 2 sided|||||||.000000009
72471001|NCT03518567|144465464|SUPERIORITY||correlation|0.02||||0.87|TWO_SIDED||||||correlation|Correlation between puffs on the topography device and grams of cannabis used per week.||||||.87
72471002|NCT04982575|144465475|OTHER||Treatment difference|-0.3||||0.2284|TWO_SIDED|95.0|-0.79|0.19|||Mixed Models Analysis|||The change in HbA1c from baseline was analysed using an ANCOVA (Analysis of Covariance) with randomised treatment and stratification factor as factors and baseline HbA1c as a covariate using retrieved participants multiple imputation of missing data regardless of treatment or stratification.||0.19|-0.79|0.2284
72471003|NCT01151423|144465485|SUPERIORITY||Hazard Ratio (HR)|2.2|||=|0.005|TWO_SIDED|95.0|1.28|3.78||Caplacizumab was compared to placebo using a one-sided log-rank test in order to assess superiority at 2.5% significance level.|Stratified log-rank test||The HR was estimated from a Cox proportional Hazards regression model with presence (yes) / absence (no) of 1 PE session prior to randomization as covariate.|The primary analysis consisted of a Kaplan-Meier analysis with time-to-response as endpoint and treatment group as the independent variable and stratified for absence/presence of one PE session prior to randomization.||3.78|1.28|= 0.005
72471004|NCT02065882|144465531|OTHER|Confirmatory t-test testing of the MCF difference (1 h post-dose minus pre-dose)|||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
72471005|NCT00475644|144465574|SUPERIORITY||Odds Ratio (OR)|0.031|||||TWO_SIDED|95.0|0.001|0.86||||||||0.860|0.001|
72505460|NCT00663858|144541995|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.592|STANDARD_ERROR_OF_MEAN|0.662||0.371|TWO_SIDED|95.0|-1.894|0.709|||ANOVA|||||0.709|-1.894|0.371
72505461|NCT00663858|144541995|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.711|STANDARD_ERROR_OF_MEAN|0.722||0.3253|TWO_SIDED|95.0|-709.0|2.132|||ANCOVA|||||2.132|-0709|0.3253
72622720|NCT02528305|144775548|SUPERIORITY_OR_OTHER|||||||0.745|||||||ANOVA|For the analysis of Health Perception||||||0.745
72471006|NCT01411241|144465575|NON_INFERIORITY|The non-inferiority was demonstrated if the lower limit of all the 95% Confidence Interval (CI) of the difference is greater than -10% for all antigens. Wilson score (without continuity adjustment) 95% two-sided CI was used for the difference of seroprotection/booster rates.|Difference in percentage|0.0|||||TWO_SIDED|95.0|-1.48|1.4||||||Non-inferiority (Group 1 - Group 2); Anti-diphtheria. Non-inferiority of Pentaxim booster dose based on seroprotection/booster response was assessed 28 days after injection.||1.40|-1.48|
72471007|NCT01411241|144465575|NON_INFERIORITY|The non-inferiority was demonstrated if the lower limit of all the 95% CI of the difference is greater than -10% for all antigens. Wilson score (without continuity adjustment) 95% two-sided CI was used for the difference of seroprotection/booster rates.|Difference in percentage|0.37|||||TWO_SIDED|95.0|-1.14|2.07||||||Non-inferiority (Group 1 - Group 2); Anti-tetanus. Non-inferiority of Pentaxim booster dose based on seroprotection/booster response was assessed 28 days after injection.||2.07|-1.14|
72471008|NCT01411241|144465575|NON_INFERIORITY|The non-inferiority was demonstrated if the lower limit of all the 95% CI of the difference is greater than -10% for all antigens. Wilson score (without continuity adjustment) 95% two-sided CI was used for the difference of seroprotection/booster rates.|Difference in percentage|0.37|||||TWO_SIDED|95.0|-1.14|2.08||||||Non-inferiority (Group 1 - Group 2); Anti-polio 1. Non-inferiority of Pentaxim booster dose based on seroprotection/booster response was assessed 28 days after injection.||2.08|-1.14|
72471009|NCT01411241|144465575|NON_INFERIORITY|The non-inferiority was demonstrated if the lower limit of all the 95% CI of the difference is greater than -10% for all antigens. Wilson score (without continuity adjustment) 95% two-sided CI was used for the difference of seroprotection/booster rates.|Difference in percentage|0.0|||||TWO_SIDED|95.0|-1.48|1.4||||||Non-inferiority (Group 1 - Group 2); Anti-polio 2. Non-inferiority of Pentaxim booster dose based on seroprotection/booster response was assessed 28 days after injection.||1.40|-1.48|
72471010|NCT01411241|144465575|NON_INFERIORITY|The non-inferiority was demonstrated if the lower limit of all the 95% CI of the difference is greater than -10% for all antigens. Wilson score (without continuity adjustment) 95% two-sided CI was used for the difference of seroprotection/booster rates.|Difference in percentage|0.37|||||TWO_SIDED|95.0|-1.15|2.09||||||Non-inferiority (Group 1 - Group 2); Anti-polio 3. Non-inferiority of Pentaxim booster dose based on seroprotection/booster response was assessed 28 days after injection.||2.09|-1.15|
72471011|NCT01411241|144465575|NON_INFERIORITY|The non-inferiority was demonstrated if the lower limit of all the 95% CI of the difference is greater than -10% for all antigens. Wilson score (without continuity adjustment) 95% two-sided CI was used for the difference of seroprotection/booster rates.|Difference in percentage|0.0|||||TWO_SIDED|95.0|-1.48|1.4||||||Non-inferiority (Group 1 - Group 2); Anti-PRP. Non-inferiority of Pentaxim booster dose based on seroprotection/booster response was assessed 28 days after injection.||1.40|-1.48|
72471012|NCT01411241|144465575|NON_INFERIORITY|The non-inferiority was demonstrated if the lower limit of all the 95% CI of the difference is greater than -10% for all antigens. Wilson score (without continuity adjustment) 95% two-sided CI was used for the difference of seroprotection/booster rates.|Difference in percentage|-0.56|||||TWO_SIDED|95.0|-3.93|2.69||||||Non-inferiority (Group 1 - Group 2); Anti-PT. Non-inferiority of Pentaxim booster dose based on seroprotection/booster response was assessed 28 days after injection.||2.69|-3.93|
72471013|NCT01411241|144465575|NON_INFERIORITY|The non-inferiority was demonstrated if the lower limit of all the 95% CI of the difference is greater than -10% for all antigens. Wilson score (without continuity adjustment) 95% two-sided CI was used for the difference of seroprotection/booster rates.|Difference in percentage|-0.36|||||TWO_SIDED|95.0|-4.87|4.06||||||Non-inferiority (Group 1 - Group 2); Anti-FHA. Non-inferiority of Pentaxim booster dose based on seroprotection/booster response was assessed 28 days after injection.||4.06|-4.87|
72471014|NCT02356705|144465595|SUPERIORITY|||||||0.39|||||||Chi-squared|||||||0.39
72471015|NCT02356705|144465596|SUPERIORITY|||||||0.39|||||||Chi-squared|||||||0.39
72471016|NCT02356705|144465597|SUPERIORITY|||||||0.88|||||||Kruskal-Wallis|||||||0.88
72471017|NCT02356705|144465599|SUPERIORITY|||||||0.01|||||||Kruskal-Wallis|||||||0.01
72471018|NCT02356705|144465600|SUPERIORITY|||||||0.08|||||||Kruskal-Wallis|||||||0.08
72471019|NCT01107899|144465605|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for the overall effect of initial inhibition on the day to return to baseline platelet function.|Regression, Linear|||||||<0.001
72471020|NCT01107899|144465607|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|p-value was obtained from an analysis of covariance model with treatment as a fixed effect and the baseline value as a covariate.||||||<0.001
72471021|NCT01107899|144465607|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|p-value was obtained from an analysis of covariance model with treatment as a fixed effect and the baseline value as a covariate.||||||<0.001
72471022|NCT01107899|144465607|SUPERIORITY_OR_OTHER|||||||0.025||95.0|||||ANCOVA|p-value was obtained from an analysis of covariance model with treatment as a fixed effect and the baseline value as a covariate.||||||0.025
72471023|NCT04292470|144465662|SUPERIORITY|||||||0.41|||||||ANOVA|||||||0.41
72471024|NCT04292470|144465663|SUPERIORITY|||||||0.09|||||||ANOVA|||For statistical testing, we used a general linear model of change in GERD symptoms from baseline to 8 weeks adjusted for the natural log of the index value (of the ratio of the change in skin conductance between patient and physician at baseline) and randomization assignment.||||0.09
72471025|NCT02906020|144465682|SUPERIORITY||LS mean difference|2.58|STANDARD_ERROR_OF_MEAN|1.87|=|0.1679|TWO_SIDED|95.0|-1.1|6.27||The threshold for statistical significance was 0.05.|MMRM|||Least-squares (LS) mean, standard errors (SE) and p-value were estimated from mixed-effect model with repeated measures (MMRM) analysis which included fixed categorical effects of treatment group, randomization strata, time point, treatment-by-time point and strata-by-time point interaction and continuous fixed covariates Baseline value and Baseline value-by-time point interaction.||6.27|-1.10|=0.1679
72471026|NCT02906020|144465683|SUPERIORITY||LS mean difference|-0.97|STANDARD_ERROR_OF_MEAN|1.85|=|0.5996|TWO_SIDED|95.0|-4.63|2.68||The threshold for statistical significance was 0.05.|MMRM|||LS mean, SE and P-value were estimated from MMRM analysis which included fixed categorical effects of treatment group, randomization strata, time point, treatment-by-time point and strata-by-time point interaction and continuous fixed covariates Baseline value and Baseline value-by-time point interaction.||2.68|-4.63|=0.5996
72505462|NCT00663858|144541995|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.324|STANDARD_ERROR_OF_MEAN|0.62||0.0333|TWO_SIDED|95.0|-2.542|-0.106|||ANCOVA|||||-0.106|-2.542|0.0333
72622721|NCT02528305|144775549|SUPERIORITY_OR_OTHER|||||||0.31|||||||ANOVA|||||||0.310
72622722|NCT02528305|144775550|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA|||||||<0.001
72622723|NCT02528305|144775551|SUPERIORITY_OR_OTHER|||||||0.005|||||||ANOVA|||||||0.005
72622724|NCT02528305|144775552|SUPERIORITY_OR_OTHER|||||||0.793|||||||ANOVA|||||||0.793
72622725|NCT02528305|144775553|SUPERIORITY_OR_OTHER|||||||0.513|||||||ANOVA|||||||0.513
72622726|NCT02528305|144775554|SUPERIORITY_OR_OTHER|||||||0.009|||||||ANOVA|||||||0.009
72622727|NCT02691494|144775555|SUPERIORITY||Odds Ratio (OR)|28.73|||<|0.001|TWO_SIDED|95.0|12.248|67.387||The P value for test of difference is by pooling the results from a logistic regression model including treatment as the main effect and baseline MBL volume as a covariate in each data set from multiple imputation.|Regression, Logistic|||||67.387|12.248|< 0.001
72622728|NCT02691494|144775555|SUPERIORITY||Odds Ratio (OR)|28.31|||<|0.001|TWO_SIDED|95.0|13.042|61.431||The P value for test of difference is by pooling the results from a logistic regression model including treatment as the main effect and baseline MBL volume as a covariate in each data set from multiple imputation.|Regression, Logistic|||||61.431|13.042|< 0.001
72622729|NCT02691494|144775556|SUPERIORITY||LS Mean of Difference|-194.5|STANDARD_ERROR_OF_MEAN|21.7|<|0.001|TWO_SIDED|||||The P value for test of difference between each elagolix treatment group and placebo is by pooling the results from an ANCOVA model with treatment as the main effect and baseline MBL volume as a covariate in each dataset from multiple imputation.|ANCOVA|||||||< 0.001
72395438|NCT01111149|144297426|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical analysis for SANS Affective Flattening (Week 12)||||>0.05
72622730|NCT02691494|144775556|SUPERIORITY||LS Mean of Difference|-164.6|STANDARD_ERROR_OF_MEAN|18.87|<|0.001|TWO_SIDED|||||The P value for test of difference between each elagolix treatment group and placebo is by pooling the results from an ANCOVA model with treatment as the main effect and baseline MBL volume as a covariate in each dataset from multiple imputation.|ANCOVA|||||||< 0.001
72395439|NCT01111149|144297426|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical analysis for SANS Alogia (Week 12)||||>0.05
72395440|NCT01111149|144297426|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical analysis for SANS Avolition (Week 12)||||>0.05
72395441|NCT01111149|144297426|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical analysis for SANS Anhedonia (Week 12)||||>0.05
72395442|NCT01111149|144297426|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical analysis for SANS Attention (Week 12)||||>0.05
72395443|NCT01111149|144297426|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical analysis of Inappropriate Affect at Week 12||||>0.05
72395444|NCT01111149|144297427|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical analysis for CPT % Omissions (Week 12)||||>0.05
72395445|NCT01111149|144297427|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical analysis for CPT% commissions (Week 12)||||>0.05
72395446|NCT01111149|144297427|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical analysis for perseveration % (week 12)||||>0.05
72395447|NCT01111149|144297428|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Fisher Exact|||Statistical analysis for Anxiety at week 12||||>0.05
72395448|NCT01111149|144297428|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Fisher Exact|||Statistical analysis for Dizziness at week 12||||>0.05
72622731|NCT02691494|144775557|SUPERIORITY||Between-Group Difference (%)|84.2|||<|0.001|TWO_SIDED|95.0|75.99|92.37||The P value is calculated based on chi-square test (or Fisher's exact test if ≥ 20% of the cells have expected cell count \< 5).|chi-square or Fisher's exact test|||||92.37|75.99|< 0.001
72395449|NCT01111149|144297428|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Fisher Exact|||Statistical analysis for Mania at week 12||||>0.05
72395450|NCT01111149|144297428|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Fisher Exact|||Statistical analysis for abnormal dreams at week 12||||>0.05
72395451|NCT01111149|144297428|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Fisher Exact|||Statistical analysis for Abdominal Pain at week 12||||>0.05
72395452|NCT01111149|144297428|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Fisher Exact|||Statistical analysis for Headache at week 12||||>0.05
72395453|NCT01111149|144297428|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Fisher Exact|||Statistical analysis for Insomnia at week 12||||>0.05
72395454|NCT01111149|144297428|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Fisher Exact|||Statistical analysis for Nausea at week 12||||>0.05
72395455|NCT01111149|144297428|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Fisher Exact|||Statistical analysis for Psychosis at week 12||||>0.05
72395456|NCT01111149|144297428|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Fisher Exact|||Statistical analysis for Dry Mouth at week 12||||>0.05
72622732|NCT02691494|144775557|SUPERIORITY||Between-Group Difference (%)|56.3|||<|0.001|TWO_SIDED|95.0|47.77|64.91||The P value is calculated based on chi-square test (or Fisher's exact test if ≥ 20% of the cells have expected cell count \< 5).|chi-square or Fisher's exact test|||||64.91|47.77|< 0.001
72622733|NCT02691494|144775558|SUPERIORITY||LS Mean of Difference|-252.3|STANDARD_ERROR_OF_MEAN|24.53|<|0.001|TWO_SIDED|||||The P value is from mixed models repeated measures (MMRM) with treatment, month, and an interaction between treatment and month as fixed effect factors, and baseline MBL volume as a covariate comparing each elagolix treatment group with placebo.|mixed model repeated measures|||||||< 0.001
72622734|NCT02691494|144775558|SUPERIORITY||LS Mean of Difference|-226.6|STANDARD_ERROR_OF_MEAN|20.5|<|0.001|TWO_SIDED|||||The P value is from mixed models repeated measures (MMRM) with treatment, month, and an interaction between treatment and month as fixed effect factors, and baseline MBL volume as a covariate comparing each elagolix treatment group with placebo.|mixed model repeated measures|||||||< 0.001
72622735|NCT02691494|144775559|SUPERIORITY||LS Mean of Difference|-196.9|STANDARD_ERROR_OF_MEAN|16.66|<|0.001|TWO_SIDED|||||The P value is from MMRM with treatment, month, and an interaction between treatment and month as fixed effect factors, and baseline MBL volume as a covariate comparing each elagolix treatment group with placebo.|mixed model repeated measures|||||||< 0.001
72622736|NCT02691494|144775559|SUPERIORITY||LS Mean of Difference|-186.1|STANDARD_ERROR_OF_MEAN|14.18|<|0.001|TWO_SIDED|||||The P value is from MMRM with treatment, month, and an interaction between treatment and month as fixed effect factors, and baseline MBL volume as a covariate comparing each elagolix treatment group with placebo.|mixed model repeated measures|||||||< 0.001
72622737|NCT02691494|144775560|SUPERIORITY||Between-Group Difference (%)|19.2||||0.146|TWO_SIDED|95.0|-5.99|44.32||The P value is calculated based on chi-square test (or Fisher's exact test if ≥ 20% of the cells have expected cell count \< 5).|chi-square or Fisher's exact test|||||44.32|-5.99|0.146
72395457|NCT01111149|144297428|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Fisher Exact|||Statistical analysis for Chest Pain at Week 12||||>0.05
72395458|NCT01111149|144297428|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Fisher Exact|||Statistical analysis for Irregular Heart Beat at week 12||||>0.05
72395459|NCT01111149|144297428|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Fisher Exact|||Statistical analysis for Weakness/Fainting at week 12||||>0.05
72622738|NCT02691494|144775560|SUPERIORITY||Between-Group Difference (%)|29.2||||0.017|TWO_SIDED|95.0|7.62|50.71||The P value is calculated based on chi-square test (or Fisher's exact test if ≥ 20% of the cells have expected cell count \< 5).|chi-square or Fisher's exact test|||||50.71|7.62|0.017
72395460|NCT01111149|144297428|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Fisher Exact|||Statistical analysis for Diarrhea at week 12||||>0.05
72395461|NCT01111149|144297428|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Fisher Exact|||Statistical analysis for Vomiting at week 12||||>0.05
72395462|NCT01111149|144297428|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Fisher Exact|||Statistical analysis for Constipation at week 12||||>0.05
72395463|NCT01111149|144297428|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Fisher Exact|||Statistical analysis for Confusion at week 12||||>0.05
72395464|NCT01111149|144297428|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Fisher Exact|||Statistical analysis for Irritability at week 12||||>0.05
72395465|NCT01111149|144297428|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Fisher Exact|||Statistical analysis for drooling at week 12||||>0.05
72395466|NCT01111149|144297428|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Fisher Exact|||Statistical analysis for Cold Sweats at week 12||||>0.05
72395467|NCT01111149|144297428|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Fisher Exact|||Statistical analysis for Blurred Vision at week 12||||>0.05
72395468|NCT01111149|144297428|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Fisher Exact|||Statistical analysis for Leg Pain/Cramps||||>0.05
72471027|NCT02906020|144465684|SUPERIORITY||LS mean difference|4.13|STANDARD_ERROR_OF_MEAN|2.13|=|0.0535|TWO_SIDED|95.0|-0.06|8.32||The threshold for statistical significance was 0.05.|MMRM|||LS mean, SE and P-value were estimated from MMRM analysis which included fixed categorical effects of treatment group, randomization strata, time point, treatment-by-time point and strata-by-time point interaction and continuous fixed covariates Baseline value and Baseline value-by-time-interaction||8.32|-0.06|=0.0535
72395469|NCT01111149|144297429|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical analysis for FTND (Week 12)||||>0.05
72395470|NCT01111149|144297429|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical analysis for MNWS 24 Hour Total (Week 12)||||>0.05
72395471|NCT01111149|144297429|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical analysis for MNWS 7 day total (Week 12)||||>0.05
72395472|NCT01111149|144297429|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical analysis for MNWS Resistance (Week 12)||||>0.05
72395473|NCT01111149|144297430|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical analysis of Beck Depression Inventory (Week 12)||||>0.05
72471028|NCT02906020|144465685|SUPERIORITY||LS mean difference|0.03|STANDARD_ERROR_OF_MEAN|0.08|=|0.74|TWO_SIDED|95.0|-0.12|0.17||The threshold for statistical significance was 0.05.|MMRM|||LS mean, SE and P-value: estimated from MMRM analysis which included fixed categorical effects of treatment group, randomization strata, time point, treatment-by-time point and strata-by-time point interaction and continuous fixed covariates Baseline value and Baseline value-by-time-interaction.||0.17|-0.12|=0.7400
72471029|NCT01810939|144465686|SUPERIORITY_OR_OTHER_LEGACY||Proportion|0.76|||||TWO_SIDED|95.0|0.7|0.81||||||||0.81|0.7|
72471030|NCT01810939|144465687|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Mantel Haenszel|||Test for difference between treatment groups in proportion with serum potassium ≥ 5.5 mEq/L||||<0.001
72471031|NCT01810939|144465688|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Mantel Haenszel|||Test for difference between treatment groups in proportion with serum potassium ≥ 5.1 mEq/L||||<0.001
72471032|NCT01810939|144465689|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Longitudinal mixed models|Test that the mean change is significantly different from zero.||Estimation of mean change in serum potassium from Part A Baseline to Part A Week 4 and test mean change different from zero.||||<0.001
72471033|NCT01810939|144465690|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||ANCOVA|||Test for difference between treatment groups in serum potassium change in Part B||||< 0.001
72471034|NCT02179177|144465697|OTHER||Mean Difference (Net)|1.0||||0.11|TWO_SIDED||||||t-test, 2 sided|||||||0.11
72471035|NCT02349152|144465701|SUPERIORITY|Power calculation was performed based on the assumption that continuous remifentanil infusion would reduce the percentage of patients with unacceptable blood glucose values (more than one BG\>180 mg/dl) to an absolute value of 20%. Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha= 0.05) between the groups. A total of 116 patients were recruited to allow for dropouts.|Risk Ratio (RR)|1.9||||0.001|TWO_SIDED|95.0|1.3|3.0|||Chi-squared|||The null hypothesis that there was no difference in the percentage of patients with two or more blood glucose values greater than 180mg/dl between the two groups. Power calculation was performed based on the assumption that continuous remifentanil infusion would reduce the percentage of patients with unacceptable blood glucose values (more than one BG\>180 mg/dl) to an absolute value of 20%.||3.0|1.3|0.001
72471036|NCT02349152|144465702|SUPERIORITY|Power calculation was performed based on the assumption that continuous remifentanil infusion would reduce the percentage of patients with unacceptable blood glucose values (more than one BG \> 180 mg) to an absolute value of 20%. Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts.||||||0.004|||||||t-test, 2 sided|||||||0.004
72471037|NCT02349152|144465703|SUPERIORITY|Power calculation was performed based on the assumption that continuous remifentanil infusion would reduce the percentage of patients with unacceptable blood glucose values (more than one BG\>180 mg/dl) to an absolute value of 20%. Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha= 0.05) between the groups. A total of 116 patients were recruited to allow for dropouts.||||||0.01|||||||Fisher Exact|||||||0.01
72542422|NCT00272961|144614638|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.3|STANDARD_ERROR_OF_MEAN|4.79||0.7883|TWO_SIDED|95.0|-11.17|8.57|||ANCOVA|||Week 10 Sitting: p-value was obtained using an ANCOVA model on the post-dose minus pre-dose difference at Week 10 with the post-dose minus pre-dose difference at Baseline as a covariate.||8.57|-11.17|0.7883
72471038|NCT02349152|144465704|SUPERIORITY|Power calculation was performed based on the assumption that continuous remifentanil infusion would reduce the percentage of patients with unacceptable blood glucose values (more than one BG \> 180 mg) to an absolute value of 20%. Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts.||||||0.0001|||||||t-test, 2 sided|||Mean Intraoperative Blood Glucose||||0.0001
72471039|NCT02349152|144465704|SUPERIORITY|Power calculation was performed based on the assumption that continuous remifentanil infusion would reduce the percentage of patients with unacceptable blood glucose values (more than one BG \> 180 mg) to an absolute value of 20%. Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts.||||||0.0003|||||||t-test, 2 sided|||Peak Intraoperative Blood Glucose||||0.0003
72471040|NCT02349152|144465704|SUPERIORITY|Power calculation was performed based on the assumption that continuous remifentanil infusion would reduce the percentage of patients with unacceptable blood glucose values (more than one BG \> 180 mg) to an absolute value of 20%. Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts.||||||0.98|||||||t-test, 2 sided|||Lowest Intraoperative Blood Glucose||||0.98
72471041|NCT02349152|144465705|SUPERIORITY|Power calculation was performed based on the assumption that continuous remifentanil infusion would reduce the percentage of patients with unacceptable blood glucose values (more than one BG \> 180 mg) to an absolute value of 20%. Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts.||||||0.14|||||||t-test, 2 sided|||Mean post-operative glucose||||0.14
72471042|NCT02349152|144465705|SUPERIORITY|Power calculation was performed based on the assumption that continuous remifentanil infusion would reduce the percentage of patients with unacceptable blood glucose values (more than one BG \> 180 mg) to an absolute value of 20%. Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts.||||||0.25|||||||t-test, 2 sided|||Peak Postoperative Blood Glucose||||0.25
72471043|NCT02349152|144465706|SUPERIORITY|Power calculation was performed based on the assumption that continuous remifentanil infusion would reduce the percentage of patients with unacceptable blood glucose values (more than one BG \> 180 mg) to an absolute value of 20%. Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts.||||||0.49|||||||t-test, 2 sided|||||||0.49
72471044|NCT02349152|144465708|SUPERIORITY|Power calculation was performed based on the assumption that continuous remifentanil infusion would reduce the percentage of patients with unacceptable blood glucose values (more than one BG \> 180 mg) to an absolute value of 20%. Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts.||||||0.401|||||||t-test, 2 sided|||Prebypass||||0.401
72471045|NCT02349152|144465708|NON_INFERIORITY|Power calculation was performed based on the assumption that continuous remifentanil infusion would reduce the percentage of patients with unacceptable blood glucose values (more than one BG \> 180 mg) to an absolute value of 20%. Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts.|||||<|0.0001|||||||t-test, 2 sided|||30 minutes after the start of CPB||||<0.0001
72471046|NCT02349152|144465708|NON_INFERIORITY|Power calculation was performed based on the assumption that continuous remifentanil infusion would reduce the percentage of patients with unacceptable blood glucose values (more than one BG \> 180 mg) to an absolute value of 20%. Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts.|||||<|0.0001|||||||t-test, 2 sided|||End of CPB||||<0.0001
72471047|NCT02349152|144465708|NON_INFERIORITY|Power calculation was performed based on the assumption that continuous remifentanil infusion would reduce the percentage of patients with unacceptable blood glucose values (more than one BG \> 180 mg) to an absolute value of 20%. Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts.|||||<|0.0001|||||||t-test, 2 sided|||End of Surgery||||<0.0001
72471048|NCT02349152|144465708|NON_INFERIORITY|Power calculation was performed based on the assumption that continuous remifentanil infusion would reduce the percentage of patients with unacceptable blood glucose values (more than one BG \> 180 mg) to an absolute value of 20%. Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts.||||||0.021|||||||t-test, 2 sided|||Postoperative (8 hours)||||0.021
72471049|NCT02349152|144465709|SUPERIORITY|Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts.||||||0.58|||||||t-test, 2 sided|||Analyzing the IL-1b Pre bypass||||0.580
72505463|NCT01371838|144542042|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the observed difference in the primary outcome measure (clinical cure rate) between the ceftaroline group and the ceftriaxone group was calculated in CE Population at the TOC visit. Noninferiority was concluded if the lower limit of the 95% CI was higher than -10% in CE Population. If non-inferioirity was achieved then a test of superioirty was conducted whereby if lower limit of 95% CI for the difference was \>0% superioirty was concluded.|Risk Difference (RD)|9.9|||||TWO_SIDED|95.0|2.8|17.1||||RD is Ceftaroline clinical cure rate minus Ceftriaxone clinical cure rate. The CI was calculated by Miettinen and Nurminen method without adjustment.|CI for risk difference was estimated by 95% Miettinen and Nurminen CI without adjustments.|The primary objective of this study was to determine the noninferiority in the clinical cure rate for ceftaroline compared to that for ceftriaxone at TOC in the CE in adult subjects with CABP.||17.1|2.8|
72505464|NCT01371838|144542043|SUPERIORITY_OR_OTHER||Risk Difference (RD)|10.7|||||TWO_SIDED|95.0|4.9|16.4||||RD is Ceftaroline clinical cure rate minus Ceftriaxone clinical cure rate. The CI was calculated by Miettinen and Nurminen method without adjustment.|CI for risk difference was estimated by 95% Miettinen and Nurminen CI without adjustments.|||16.4|4.9|
72622739|NCT02691494|144775561|SUPERIORITY||LS Mean of Difference|-194.5|STANDARD_ERROR_OF_MEAN|20.56|<|0.001|TWO_SIDED|||||The P value is from MMRM with treatment, month, and an interaction between treatment and month as fixed effect factors, and baseline MBL volume as a covariate comparing each elagolix treatment group with placebo.|mixed model repeated measures|||||||< 0.001
72622740|NCT02691494|144775561|SUPERIORITY||LS Mean of Difference|-125.0|STANDARD_ERROR_OF_MEAN|17.55|<|0.001|TWO_SIDED|||||The P value is from MMRM with treatment, month, and an interaction between treatment and month as fixed effect factors, and baseline MBL volume as a covariate comparing each elagolix treatment group with placebo.|mixed model repeated measures|||||||< 0.001
72622741|NCT00787800|144775562|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Log Rank|||||||1.0
72622742|NCT00787800|144775564|SUPERIORITY_OR_OTHER|||||||0.05|||||||t-test, 2 sided|||||||0.050
72622743|NCT00787800|144775566|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
72622744|NCT00913835|144775577|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.054||||0.8049|TWO_SIDED|90.0|0.751|1.478|||Log Rank|Stratified by prior platinum treatment, platinum-refractory versus platinum-resistance reaction.||||1.478|0.751|0.8049
72622745|NCT00913835|144775578|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.115||||0.6346|TWO_SIDED|90.0|0.768|1.618|||Log Rank|Stratified by prior platinum treatment, platinum-refractory versus platinum-resistance reaction.||||1.618|0.768|0.6346
72622746|NCT00913835|144775579|SUPERIORITY_OR_OTHER_LEGACY|||||||0.619|TWO_SIDED||||||Fisher Exact|||||||0.6190
72471050|NCT02349152|144465709|SUPERIORITY|Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts.||||||0.815|||||||t-test, 2 sided|||Analyzing the IL-1b CPB-30||||0.815
72471051|NCT02349152|144465709|SUPERIORITY|Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts.||||||0.715|||||||t-test, 2 sided|||Analyzing the CPB-END||||0.715
72471052|NCT02349152|144465709|SUPERIORITY|Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts.||||||0.33|||||||t-test, 2 sided|||Analyzing the IL-1b post-bypass||||0.330
72471053|NCT02349152|144465709|SUPERIORITY|Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts.||||||0.651|||||||t-test, 2 sided|||Analyzing the IL-1b 8 HR||||0.651
72471054|NCT02349152|144465709|SUPERIORITY|Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts.||||||0.439|||||||t-test, 2 sided|||Analyzing the IL-6 Pre bypass||||0.439
72471055|NCT02349152|144465709|SUPERIORITY|Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts.||||||0.284|||||||t-test, 2 sided|||Analyzing the IL-6 CPB-30||||0.284
72471056|NCT02349152|144465709|SUPERIORITY|Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts.||||||0.779|||||||t-test, 2 sided|||Analyzing the CPB-END||||0.779
72471057|NCT02349152|144465709|SUPERIORITY|Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts.||||||0.274|||||||t-test, 2 sided|||Analyzing the IL-6 post-bypass||||0.274
72471058|NCT02349152|144465709|SUPERIORITY|Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts.||||||0.601|||||||t-test, 2 sided|||Analyzing the IL-6 8HR||||0.601
72471059|NCT02349152|144465709|SUPERIORITY|Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts.||||||0.315|||||||t-test, 2 sided|||Analyzing the TNFa Pre-bypass||||0.315
72471060|NCT02349152|144465709|SUPERIORITY|Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts.||||||0.062|||||||t-test, 2 sided|||Analyzing the TNFa CPB-30||||0.062
72622747|NCT00637156|144775590|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin is 0.1.|Risk Difference (RD)|0.113||||1|TWO_SIDED|95.0|0.022|0.201||The posterior probability of non-inferiority was calculated and presented instead of the p-value.|Bayesian model||The posterior mean of P1-P0, along with the corresponding 95% highest posterior density (HPD) interval, was presented instead of the usual 95% CI.|"The null hypothesis H0: p1 + d ≤ p0, and the alternative hypothesis is Ha: p1 + d \> p0 where P0 and P1 are the overall success rates in the control group and the investigational group respectively, and d is the non-inferiority margin. The analyses used Bayesian methodology. Should the posterior probability P(p1 - p0 \> -d \| data) be at least 0.95, then the null non-inferiority hypothesis will be rejected, and non-inferiority of the investigational device to the control will be claimed."||0.201|0.022|1.000
72622748|NCT00637156|144775590|SUPERIORITY_OR_OTHER|||||||0.993||||||The posterior probability of superiority was calculated and presented instead of the p-value.|Bayesian model|||Superiority comparison of overall success rates in two treatment groups was a secondary objective of this trial. Superiority analysis was performed if non-inferiority was demonstrated. If the posterior probability is at least 0.95, a claim of superiority can be made.||||0.993
72622749|NCT00637156|144775591|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin is 0.1.|Risk Difference (RD)|0.088||||1|TWO_SIDED|95.0|0.012|0.167||The posterior probability of non-inferiority was calculated and presented instead of the p-value.|Bayesian model||The posterior mean of P1-P0, along with the corresponding 95% highest posterior density (HPD) interval, was presented instead of the usual 95% CI.|"The null hypothesis H0: p1 + d ≤ p0, and the alternative hypothesis is Ha: p1 + d \> p0 where P0 and P1 are the NDI success rates in the control group and the investigational group respectively, and d is the non-inferiority margin. The analyses used Bayesian methodology. Should the posterior probability P (p1 - p0 \> -d \| data) be at least 0.95, then the null non-inferiority hypothesis will be rejected, and non-inferiority of the investigational device to the control will be claimed."||0.167|0.012|1.000
72622750|NCT00637156|144775591|SUPERIORITY_OR_OTHER|||||||0.99||||||The posterior probability of superiority was calculated and presented instead of the p-value.|Bayesian model|||Superiority comparison of NDI success rates in two treatment groups was performed if non-inferiority was demonstrated.||||0.990
72471061|NCT02349152|144465709|SUPERIORITY|Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts.||||||0.09|||||||t-test, 2 sided|||Analyzing the TNFa CPB-END||||0.090
72471062|NCT02349152|144465709|SUPERIORITY|Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts.||||||0.004|||||||t-test, 2 sided|||Analyzing the TNFa- post-bypass||||0.004
72471063|NCT02349152|144465709|SUPERIORITY|Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts.||||||0.074|||||||t-test, 2 sided|||Analyzing the TNFa-8HR||||0.074
72471064|NCT02349152|144465710|NON_INFERIORITY|Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts.||||||0.74|||||||t-test, 2 sided|||Analyzing the ACTH Pre-bypass group||||0.740
72471065|NCT02349152|144465710|NON_INFERIORITY|Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts.|||||<|0.0001|||||||t-test, 2 sided|||Analyzing the ACTH CPB-30 group.||||<0.0001
72471066|NCT02349152|144465710|NON_INFERIORITY|Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts.|||||<|0.0001|||||||t-test, 2 sided|||Analyzing the ACTH CPB-END||||<0.0001
72471067|NCT02349152|144465710|NON_INFERIORITY|Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts.|||||<|0.0001|||||||t-test, 2 sided|||Analyzing the ACTH post-bypass||||<0.0001
72471068|NCT02349152|144465710|SUPERIORITY|Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts.||||||0.014|||||||t-test, 2 sided|||Analyzing the ACTH 8-hr||||0.014
72471069|NCT02349152|144465710|SUPERIORITY|Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts.||||||0.1|||||||t-test, 2 sided|||Analyzing the GH- Pre-bypass||||0.100
72471070|NCT02349152|144465710|SUPERIORITY|Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts.|||||<|0.0001|||||||t-test, 2 sided|||GH-CPB-30||||<0.0001
72471071|NCT02349152|144465710|SUPERIORITY|Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts.||||||0.009|||||||t-test, 2 sided|||Analyzing the GH-CPB-END||||0.009
72471072|NCT02349152|144465710|SUPERIORITY|Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts.||||||0.046|||||||t-test, 2 sided|||GH-Post-bypass||||0.046
72505465|NCT01371838|144542044|SUPERIORITY_OR_OTHER||Risk Difference (RD)|8.5|||||TWO_SIDED|95.0|1.8|15.4||||RD is Ceftaroline clinical cure rate minus Ceftriaxone clinical cure rate. The CI was calculated by Miettinen and Nurminen method without adjustment.|CI for risk difference was estimated by 95% Miettinen and Nurminen CI without adjustments.|||15.4|1.8|
72505466|NCT01371838|144542045|SUPERIORITY_OR_OTHER||Risk Difference (RD)|13.0|||||TWO_SIDED|95.0|6.8|19.2||||RD is Ceftaroline clinical cure rate minus Ceftriaxone clinical cure rate. The CI was calculated by Miettinen and Nurminen method without adjustment.|CI for risk difference was estimated by 95% Miettinen and Nurminen CI without adjustments. If lower limit of 95% CI for the risk difference was \>0% superioirty was concluded in this population.|||19.2|6.8|
72395474|NCT01111149|144297431|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical analysis for SAS (Week 12)||||>0.05
72471073|NCT02349152|144465710|SUPERIORITY|Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts.||||||0.695|||||||t-test, 2 sided|||Analyzing the GH-8-hr||||0.695
72471074|NCT02349152|144465710|SUPERIORITY|Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts.||||||0.455|||||||t-test, 2 sided|||Analyzing the Glucagon Pre Bypass||||0.455
72471075|NCT02349152|144465710|SUPERIORITY|Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts.||||||0.059|||||||t-test, 2 sided|||Analyzing the Glucagon CPB-30||||0.059
72471076|NCT02349152|144465710|SUPERIORITY|Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts.||||||0.175|||||||t-test, 2 sided|||Analyzing the Glucagon CPB-END||||0.175
72471077|NCT02349152|144465710|SUPERIORITY|Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts.||||||0.062|||||||t-test, 2 sided|||Analyzing the Glucagon Post-bypass||||0.062
72471078|NCT02349152|144465710|SUPERIORITY|Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts.||||||0.261|||||||t-test, 2 sided|||Analyzing the Glucagon 8-hr||||0.261
72505467|NCT01371838|144542046|SUPERIORITY_OR_OTHER||Risk Difference (RD)|15.2|||||TWO_SIDED|95.0|2.7|27.1||||RD is Ceftaroline clinical cure rate minus Ceftriaxone clinical cure rate. The CI was calculated by Miettinen and Nurminen method without adjustment.|CI for risk difference was estimated by 95% Miettinen and Nurminen CI without adjustments.|||27.1|2.7|
72622751|NCT00637156|144775592|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin is 0.1.|Risk Difference (RD)|0.05||||1|TWO_SIDED|95.0|-0.014|0.119||The posterior probability of non-inferiority was calculated and presented instead of the p-value.|Bayesian model||The posterior mean of P1-P0, along with the corresponding 95% highest posterior density (HPD) interval, was presented instead of the usual 95% CI.|"The null hypothesis H0: p1 + d ≤ p0, and the alternative hypothesis is Ha: p1 + d \> p0 where P0 and P1 are the neurological success rates in the control group and the investigational group respectively, and d is the non-inferiority margin. The analyses used Bayesian methodology. Should the posterior probability P (p1 - p0 \> -d \| data) be at least 0.95, then the null non-inferiority hypothesis will be rejected, and non-inferiority of the investigational device to the control will be claimed."||0.119|-0.014|1.000
72622752|NCT00637156|144775592|SUPERIORITY_OR_OTHER|||||||0.931||||||The posterior probability of superiority was calculated and presented instead of the p-value.|Bayesian model|||Superiority comparison of neurological success rates in two treatment groups was performed if non-inferiority was demonstrated.||||0.931
72622753|NCT00637156|144775593|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin is 0.1.|Risk Difference (RD)|0.021||||1|TWO_SIDED|95.0|-0.019|0.062||The posterior probability of non-inferiority was calculated and presented instead of the p-value.|Bayesian model||The posterior mean of P1-P0, along with the corresponding 95% highest posterior density (HPD) interval, was presented instead of the usual 95% CI.|"The null hypothesis H0: p1 + d ≤ p0, and the alternative hypothesis is Ha: p1 + d \> p0 where P0 and P1 are the neck pain success rates in the control group and the investigational group respectively, and d is the non-inferiority margin. The analyses used Bayesian methodology. Should the posterior probability P (p1 - p0 \> -d \| data) be at least 0.95, then the null non-inferiority hypothesis will be rejected, and non-inferiority of the investigational device to the control will be claimed."||0.062|-0.019|1.000
72622754|NCT00637156|144775593|SUPERIORITY_OR_OTHER|||||||0.852||||||The posterior probability of superiority was calculated and presented instead of the p-value.|Bayesian model|||Superiority comparison of neck pain success rates in two treatment groups was performed if non-inferiority was demonstrated.||||0.852
72622755|NCT00637156|144775594|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin is 0.1.|Risk Difference (RD)|-0.008||||0.997|TWO_SIDED|95.0|-0.073|0.056||The posterior probability of non-inferiority was calculated and presented instead of the p-value.|Bayesian model||The posterior mean of P1-P0, along with the corresponding 95% highest posterior density (HPD) interval, was presented instead of the usual 95% CI.|"The null hypothesis H0: p1 + d ≤ p0, and the alternative hypothesis is Ha: p1 + d \> p0 where P0 and P1 are the arm pain success rates in the control group and the investigational group respectively, and d is the non-inferiority margin. The analyses used Bayesian methodology. Should the posterior probability P (p1 - p0 \> -d \| data) be at least 0.95, then the null non-inferiority hypothesis will be rejected, and non-inferiority of the investigational device to the control will be claimed."||0.056|-0.073|0.997
72395475|NCT01111149|144297431|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical analysis for BAS items 1-3 (week 12)||||>0.05
72505468|NCT01371838|144542047|SUPERIORITY_OR_OTHER||Risk Difference (RD)|11.9|||||TWO_SIDED|95.0|-2.2|25.8||||RD is Ceftaroline clinical cure rate minus Ceftriaxone clinical cure rate. The CI was calculated by Miettinen and Nurminen method without adjustment.|CI for risk difference was estimated by 95% Miettinen and Nurminen CI without adjustments.|||25.8|-2.2|
72505469|NCT01371838|144542050|SUPERIORITY_OR_OTHER||Risk Difference (RD)|15.2|||||TWO_SIDED|95.0|2.7|27.1||||RD is (Ceftaroline-Ceftriaxone) microbiologically favourable outcome rate. The CI was calculated by Miettinen and Nurminen method without adjustment.|CI for risk difference was estimated by 95% Miettinen and Nurminen CI without adjustments.|||27.1|2.7|
72505470|NCT01371838|144542051|SUPERIORITY_OR_OTHER||Risk Difference (RD)|11.9|||||TWO_SIDED|95.0|-2.2|25.8||||RD is (Ceftaroline-Ceftriaxone) microbiologically favourable outcome rate. The CI was calculated by Miettinen and Nurminen method without adjustment.|CI for risk difference was estimated by 95% Miettinen and Nurminen CI without adjustments.|||25.8|-2.2|
72505471|NCT01371838|144542052|SUPERIORITY_OR_OTHER||Risk Difference (RD)|13.0|||||TWO_SIDED|95.0|6.8|19.2||||RD is Ceftaroline minus Ceftriaxone overall success rate. The CI was calculated by Miettinen and Nurminen method without adjustment.|CI for risk difference was estimated by 95% Miettinen and Nurminen CI without adjustments.|||19.2|6.8|
72622756|NCT00637156|144775594|SUPERIORITY_OR_OTHER|||||||0.395||||||The posterior probability of superiority was calculated and presented instead of the p-value.|Bayesian model|||Superiority comparison of arm pain success rates in two treatment groups was performed if non-inferiority was demonstrated.||||0.395
72505472|NCT01371838|144542053|SUPERIORITY_OR_OTHER||Risk Difference (RD)|9.9|||||TWO_SIDED|95.0|2.8|17.1||||RD is Ceftaroline clinical cure rate minus Ceftriaxone clinical cure rate. The CI was calculated by Miettinen and Nurminen method without adjustment.|CI for risk difference was estimated by 95% Miettinen and Nurminen CI without adjustments.|||17.1|2.8|
72395476|NCT01111149|144297431|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical analysis for BAS item 4 (Week 12)||||>0.05
72505473|NCT01371838|144542054|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.3|||||TWO_SIDED|95.0|-2.5|3.0||||RD is Ceftaroline minus Ceftriaxone No-relapse rate. The CI was calculated by Miettinen and Nurminen method without adjustment.|CI for risk difference was estimated by 95% Miettinen and Nurminen CI without adjustments.|||3.0|-2.5|
72505474|NCT01371838|144542055|SUPERIORITY_OR_OTHER||Risk Difference (RD)|1.1|||||TWO_SIDED|95.0|-2.4|4.5||||RD is Ceftaroline minus Ceftriaxone No-relapse rate. The CI was calculated by Miettinen and Nurminen method without adjustment.|CI for risk difference was estimated by 95% Miettinen and Nurminen CI without adjustments.|||4.5|-2.4|
72395477|NCT01111149|144297432|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical analysis for systolic blood pressure (Week 12)||||>0.05
72395478|NCT01111149|144297432|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical analysis for diastolic blood pressure (Week 12)||||>0.05
72395479|NCT01111149|144297433|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical analysis for Vital Signs - Weight (Week 12)||||>0.05
72395480|NCT01111149|144297434|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical analysis for Smoking Abstinence - Number of Cigarettes Smoked (Week 12)||||>0.05
72471079|NCT02349152|144465711|SUPERIORITY|||||||0.06|||||||Chi-squared|||30-day mortality||||0.06
72471080|NCT02349152|144465711|SUPERIORITY|||||||0.03|||||||Chi-squared|||30-day readmission||||0.03
72471081|NCT02349152|144465711|SUPERIORITY|||||||0.24|||||||Chi-squared|||Cerebral Vascular Accident||||0.24
72471082|NCT02349152|144465711|SUPERIORITY|||||||0.93|||||||Chi-squared|||Prolonged Mechanical Ventilation||||0.93
72471083|NCT02349152|144465711|SUPERIORITY|||||||1|||||||Chi-squared|||Renal Failure||||1
72471084|NCT02349152|144465711|SUPERIORITY|||||||0.1|||||||Chi-squared|||Atrial Fibrillation||||0.10
72471085|NCT02349152|144465711|SUPERIORITY|||||||1|||||||Chi-squared|||cardiac arrest||||1
72471086|NCT02349152|144465712|SUPERIORITY|||||||0.205|||||||t-test, 2 sided|||Hrs 0-6||||0.205
72471087|NCT02349152|144465712|SUPERIORITY|||||||0.339|||||||t-test, 2 sided|||Hrs 7-12||||0.339
72471088|NCT02349152|144465712|SUPERIORITY|||||||0.006|||||||t-test, 2 sided|||Hrs 13-18||||0.006
72471089|NCT02349152|144465712|SUPERIORITY|||||||0.747|||||||t-test, 2 sided|||Hrs 19-24||||0.747
72471090|NCT02349152|144465712|SUPERIORITY|||||||0.568|||||||t-test, 2 sided|||Hrs 25-30||||0.568
72471091|NCT02349152|144465712|SUPERIORITY|||||||0.924|||||||t-test, 2 sided|||Hrs 31-36||||0.924
72471092|NCT02349152|144465712|SUPERIORITY|||||||0.501|||||||t-test, 2 sided|||Hrs 37-42||||0.501
72471093|NCT02349152|144465712|SUPERIORITY|||||||0.977|||||||t-test, 2 sided|||Hrs 43-48||||0.977
72471094|NCT02349152|144465716|SUPERIORITY|||||||0.35|||||||Wilcoxon (Mann-Whitney)|||||||0.350
72471095|NCT02330094|144465741|SUPERIORITY|||||||0.7|||||||t-test, 2 sided|||||||0.7
72471096|NCT02330094|144465742|SUPERIORITY|||||||0.79|||||||ANOVA|||||||0.79
72471097|NCT02330094|144465743|SUPERIORITY|||||||0.66|||||||ANOVA|||||||0.66
72471098|NCT01516749|144465772|SUPERIORITY_OR_OTHER|||||||0.024||||||significance was accepted at p\<0.05|t-test, 2 sided|||Significance of decrease in modified Sartorius score from Baseline to 8 weeks||||0.024
72471099|NCT01516749|144465773|SUPERIORITY_OR_OTHER|||||||0.006||||||Significance was accepted at p\<0.05|t-test, 2 sided|||Significance of reductions in Physican Global Assessment mean values between baseline and 8 weeks of therapy||||0.006
72471100|NCT01516749|144465773|SUPERIORITY_OR_OTHER|||||||0.019||||||Significance was accepted at p\<0.05|t-test, 2 sided|||Significance of reductions in Patient Global Assessment mean values between baseline and 8 weeks of therapy||||0.019
72471101|NCT01732549|144465776|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.0315||||||Log-rank test adjusting for presence (or absence) of visceral metastases, opioid analgesic use and region (Eastern Europe, Western Europe). Two-sided p-value.|Log Rank|||Stratified\[a\]||||=0.0315
72471102|NCT01732549|144465776|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.0344|||||||Log Rank|||Unstratified\[b\]||||=0.0344
72471103|NCT01732549|144465777|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.443|||||||Log Rank|Adjusting for presence (or absence) of visceral metastases, opioid analgesic use and region (Eastern Europe, Western Europe). One-sided p-value||Stratified\[a\]||||=0.4430
72471104|NCT01732549|144465778|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5219|||||||Log Rank|Adjusting for presence (or absence) of visceral metastases, opioid analgesic use and region (Eastern Europe, Western Europe). One-sided p-value||Stratified\[a\]||||0.5219
72471105|NCT01732549|144465779|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.5442|||||||Log Rank|Adjusting for presence (or absence) of visceral metastases, opioid analgesic use and region (Eastern Europe, Western Europe). One-sided p-value||Stratified\[a\]||||=0.5442
72471106|NCT01732549|144465780|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.112|||||||Log Rank|Adjusting for presence (or absence) of visceral metastases, opioid analgesic use and region (Eastern Europe, Western Europe). One-sided p-value||Stratified\[a\]||||=0.1120
72471107|NCT01732549|144465781|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.2491|||||||Log Rank|Adjusting for presence (or absence) of visceral metastases, opioid analgesic use (or not) \& region (Eastern Europe, Western Europe). One-sided p-value||Stratified\[a\]||||=0.2491
72471108|NCT00584077|144465793|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED|95.0|||||ANOVA|||Each subject served as their own control as a comparison of the airway innervated (contralateral native lung) with the denervated airway (allograft)||||<0.01
72471109|NCT00584077|144465794|SUPERIORITY_OR_OTHER||||||<|0.01||||||P value was adjusted for multiple comparisons using Bonferroni test|ANOVA|||For the cross-sectional and longitudinal groups, a comparison of cough frequency after airway irritation of the main carina, and the proximal and distal anastomotic sites was performed using one-way analysis of variance with Bonferroni test. In the longitudinal cohort, a comparison of the cough frequencies at different airway sites at 1.5 and 12 months was performed using one-way analysis of variance with Bonferroni test.||||<0.01
72471110|NCT01150461|144465850|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||Wilcoxon (Mann-Whitney)|||Mann-Whitney-Wilcoxon test||||0.02
72471111|NCT01150461|144465851|SUPERIORITY_OR_OTHER|||||||0.06||95.0|||||Wilcoxon (Mann-Whitney)|||Mann-Whitney-Wilcoxon test||||0.06
72471112|NCT01681992|144465852|NON_INFERIORITY|The lower limit of the 2-sided 97.5% confidence interval (CI) on the group difference (Inv\_MMR\_Min minus Com\_MMR) in seroresponse rate should be ≥ -5% for antibodies to measles virus when tested with ELISA.|Difference in seroresponse rate|-5.48|||||TWO_SIDED|97.5|-7.65|-3.43|||||Asymptotic standardized 97.5% CI for the difference in seroresponse rate.|Non-inferiority of Inv\_MMR\_Min vaccine compared to Com\_MMR vaccine in terms of seroresponse rate to measles virus at Day 42.||-3.43|-7.65|
72471113|NCT01681992|144465852|NON_INFERIORITY|The lower limit of the 2-sided 97.5% confidence interval (CI) on the group difference (Inv\_MMR\_Med minus Com\_MMR) in seroresponse rate should be ≥ -5% for antibodies to measles virus when tested with ELISA.|Difference in seroresponse rate|-2.08|||||TWO_SIDED|97.5|-3.96|-0.27|||||Asymptotic standardized 97.5% CI for the difference in seroresponse rate.|Non-inferiority of Inv\_MMR\_Med vaccine compared to Com\_MMR vaccine in terms of seroresponse rate to measles virus at Day 42.||-0.27|-3.96|
72471114|NCT01681992|144465853|NON_INFERIORITY|The lower limit of the 2-sided 97.5% CI on the group difference (Inv\_MMR\_Min minus Com\_MMR) in seroresponse rate should be ≥ -5% for antibodies to mumps virus when tested with ELISA.|Difference in seroresponse rate|-0.42|||||TWO_SIDED|97.5|-1.91|1.04|||||Asymptotic standardized 97.5% CI for the difference in seroresponse rate.|Non-inferiority of Inv\_MMR\_Min vaccine compared to Com\_MMR vaccine in terms of seroresponse rate to mumps virus at Day 42.||1.04|-1.91|
72576675|NCT00094861|144680140|SUPERIORITY_OR_OTHER||Chi-Square Statistic|0.0294||||0.8639||95.0||||Generalized Cochran-Mantel-Haenszel test for general association.|Cochran-Mantel-Haenszel|Stratified by disease stage, ECOG performance status, and estimated weight loss in the 3 months before study randomization.||||||0.8639
72395481|NCT01111149|144297435|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical analysis for Smoking Abstinence - Exhaled Carbon Monoxide (Week 12)||||>0.05
72395482|NCT01111149|144297436|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical analysis for Vital Signs - Pulse (Week 12)||||>0.05
72395483|NCT01111149|144297437|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical analysis for Lifetime Suicidal Ideation (Week 12)||||>0.05
72395484|NCT01111149|144297437|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical analysis for Lifetime Suicide Attempts (Week 12)||||>0.05
72395485|NCT01111149|144297438|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical analysis for SAPS Total Composite Score - Week 12||||>0.05
72395486|NCT01111149|144297438|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical analysis for SAPS Total Global - Week 12||||>0.05
72395487|NCT01111149|144297438|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical analysis for SAPS Hallucinations - Week 12||||>0.05
72395488|NCT01111149|144297438|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical analysis for Delusions - Week 12||||>0.05
72395489|NCT01111149|144297438|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical Analysis for SAPS Bizarre Behavior - Week 12||||>0.05
72395490|NCT01111149|144297438|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical analysis for SAPS Thought Disorder - Week 12||||>0.05
72395491|NCT01111149|144297439|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical analysis for BPRS Total - Week 12||||>0.05
72395492|NCT01111149|144297439|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical analysis for BPRS Positive Subscale - Week 12||||>0.05
72395493|NCT01111149|144297439|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical analysis for BPRS Negative Subscale - Week 12||||>0.05
72395494|NCT01111149|144297439|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical analysis for Mania Subscale - Week 12||||>0.05
72471115|NCT01681992|144465853|NON_INFERIORITY|The lower limit of the 2-sided 97.5% CI on the group difference (Inv\_MMR\_Med minus Com\_MMR) in seroresponse rate should be ≥ -5% for antibodies to mumps virus when tested with ELISA.|Difference in seroresponse rate|-0.58|||||TWO_SIDED|97.5|-2.11|0.91|||||Asymptotic standardized 97.5% CI for the difference in seroresponse rate.|Non-inferiority of Inv\_MMR\_Med vaccine compared to Com\_MMR vaccine in terms of seroresponse rate to mumps virus at Day 42.||0.91|-2.11|
72471116|NCT01681992|144465854|NON_INFERIORITY|The lower limit of the 2-sided 97.5% CI on the group difference (Inv\_MMR\_Min minus Com\_MMR) in seroresponse rate should be ≥ -10% for antibodies to mumps virus when tested with PRNT.|Difference in seroresponse rate|-9.41|||||TWO_SIDED|97.5|-13.2|-5.62|||||Asymptotic standardized 97.5% CI for the difference in seroresponse rate.|Non-inferiority of Inv\_MMR\_Min vaccine compared to Com\_MMR vaccine in terms of seroresponse rate to mumps virus at Day 42.||-5.62|-13.20|
72395495|NCT01111149|144297439|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical analysis for Disorientation Subscale - Week 12||||>0.05
72395496|NCT01111149|144297439|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical analysis for BPRS Depression Subscale - Week 12||||>0.05
72395497|NCT01111149|144297440|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical analysis for Hit Reaction Time - CPT (Week 12)||||>0.05
72395498|NCT01111149|144297441|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical analysis for Variability of Standard Error - CPT (Week 12)||||>0.05
72395499|NCT01111149|144297442|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical analysis for Detectibility (d') of Continuous Performance Test (Week 12)||||>0.05
72395500|NCT01111149|144297443|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical analysis for Response Style Indicator (Beta) for CPT (week 12)||||>0.05
72395501|NCT01111149|144297444|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical analysis for WISDM Total (Week 12)||||>0.05
72395502|NCT01111149|144297444|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical Analysis for WISDM Cognition (Week 12)||||>0.05
72395503|NCT01111149|144297444|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical analysis for WISDM Craving (Week 12)||||>0.05
72395504|NCT01111149|144297445|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical analysis for MNWS % Urge to Smoke (Week 12)||||>0.05
72395505|NCT01111149|144297445|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical analysis for MNWS % Strong Urge (Week 12)||||>0.05
72395506|NCT01111149|144297446|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical analysis for AIMS Total (Week 12)||||>0.05
72395507|NCT01111149|144297446|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical analysis for AIMS Severity Index (Week 12)||||>0.05
72395508|NCT01111149|144297446|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical Analysis for AIMS Global Score (Week 12)||||>0.05
72395509|NCT00759954|144297447|NON_INFERIORITY_OR_EQUIVALENCE|The 90% confidence intervals for the ratios (test/reference) of the least squares means of the non-transformed parameters Cmax, AUClast, AUCinf, Tmax, λz, and T1/2, were calculated. The Wilcoxon signed rank test was used for a nonparametric comparison of Tmax values and a significant difference was defined a priori as p \< 0.05.|mean ratio|97.19|||<|0.05||90.0|91.31|103.45|||ANOVA|||||103.45|91.31|<0.05
72395510|NCT00759954|144297449|NON_INFERIORITY_OR_EQUIVALENCE|The 90% confidence intervals for the ratios (test/reference) of the least squares means of the non-transformed parameters Cmax, AUClast, AUCinf, Tmax, λz, and T1/2, were calculated. The Wilcoxon signed rank test was used for a nonparametric comparison of Tmax values and a significant difference was defined a priori as p \< 0.05.|mean ratio|95.82|||<|0.05||90.0|92.93|98.8|||ANOVA|Analysis of Variance for the log-transformed AUC. The 90% confidence interval for the ratio of AUC(Test)/AUC(Ref) is provided.||||98.80|92.93|< 0.05
72395511|NCT00759954|144297450|NON_INFERIORITY_OR_EQUIVALENCE|The 90% confidence intervals for the ratios (test/reference) of the least squares means of the non-transformed parameters Cmax, AUClast, AUCinf, Tmax, λz, and T1/2, were calculated. The Wilcoxon signed rank test was used for a nonparametric comparison of Tmax values and a significant difference was defined a priori as p \< 0.05.|mean ratio|98.1|||<|0.05||90.0|94.2|102.1|||ANOVA|||||102.1|94.2|< 0.05
72395512|NCT02320149|144297461|SUPERIORITY||Least Squares Mean Difference|-5.2|||<|0.0001|TWO_SIDED|95.0|-6.7|-3.6||Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.|ANCOVA||sarecycline - placebo|||-3.6|-6.7|< 0.0001
72395513|NCT02320149|144297462|SUPERIORITY||Treatment Rate Difference|11.05|||<|0.0001|TWO_SIDED|95.0|6.39|15.72||P-values were based on the test of general association between the response and treatment group using Cochran-Mantel-Haenszel test with pooled site as stratification factor.|Cochran-Mantel-Haenszel||sarecycline - placebo|||15.72|6.39|< 0.0001
72622757|NCT00637156|144775595|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin is 0.1.|Risk Difference (RD)|0.024||||1|TWO_SIDED|95.0|-0.042|0.088||The posterior probability of non-inferiority was calculated and presented instead of the p-value.|Bayesian model||The posterior mean of P1-P0, along with the corresponding 95% highest posterior density (HPD) interval, was presented instead of the usual 95% CI.|"The null hypothesis H0: p1 + d ≤ p0, and the alternative hypothesis is Ha: p1 + d \> p0 where P0 and P1 are the SF-36 PCS success rates in the control group and the investigational group respectively, and d is the non-inferiority margin. The analyses used Bayesian methodology. Should the posterior probability P (p1 - p0 \> -d \| data) be at least 0.95, then the null non-inferiority hypothesis will be rejected, and non-inferiority of the investigational device to the control will be claimed."||0.088|-0.042|1.000
72622758|NCT00637156|144775595|SUPERIORITY_OR_OTHER|||||||0.767||||||The posterior probability of superiority was calculated and presented instead of the p-value.|Bayesian model|||Superiority comparison of SF-36 PCS success rates in two treatment groups was performed if non-inferiority was demonstrated.||||0.767
72622759|NCT00637156|144775596|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin is 0.1.|Risk Difference (RD)|-0.024||||0.945|TWO_SIDED|95.0|-0.12|0.067||The posterior probability of non-inferiority was calculated and presented instead of the p-value.|Bayesian model||The posterior mean of P1-P0, along with the corresponding 95% highest posterior density (HPD) interval, was presented instead of the usual 95% CI.|"The null hypothesis H0: p1 + d ≤ p0, and the alternative hypothesis is Ha: p1 + d \> p0 where P0 and P1 are the SF-36 MCS success rates in the control group and the investigational group respectively, and d is the non-inferiority margin. The analyses used Bayesian methodology. Should the posterior probability P (p1 - p0 \> -d \| data) be at least 0.95, then the null non-inferiority hypothesis will be rejected, and non-inferiority of the investigational device to the control will be claimed."||0.067|-0.120|0.945
72622760|NCT00637156|144775597|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin is 0.1.|Risk Difference (RD)|-0.017||||0.997|TWO_SIDED|95.0|-0.072|0.04||The posterior probability of non-inferiority was calculated and presented instead of the p-value.|Bayesian model||The posterior mean of P1-P0, along with the corresponding 95% highest posterior density (HPD) interval, was presented instead of the usual 95% CI.|"The null hypothesis H0: p1 + d ≤ p0, and the alternative hypothesis is Ha: p1 + d \> p0 where P0 and P1 are the FSU success rates in the control group and the investigational group respectively, and d is the non-inferiority margin. The analyses used Bayesian methodology. Should the posterior probability P (p1 - p0 \> -d \| data) be at least 0.95, then the null non-inferiority hypothesis will be rejected, and non-inferiority of the investigational device to the control will be claimed."||0.040|-0.072|0.997
72622761|NCT00637156|144775597|SUPERIORITY_OR_OTHER|||||||0.271||||||The posterior probability of superiority was calculated and presented instead of the p-value.|Bayesian model|||Superiority comparison of FSU success rates in two treatment groups was performed if non-inferiority was demonstrated.||||0.271
72622762|NCT00637156|144775598|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin is 0.1.|Risk Difference (RD)|0.013||||1|TWO_SIDED|95.0|-0.013|0.04||The posterior probability of non-inferiority was calculated and presented instead of the p-value.|Bayesian model||The posterior mean of P1-P0, along with the corresponding 95% highest posterior density (HPD) interval, was presented instead of the usual 95% CI.|"The null hypothesis H0: p1 + d ≤ p0, and the alternative hypothesis is Ha: p1 + d \> p0 where P0 and P1 are the gait success rates in the control group and the investigational group respectively, and d is the non-inferiority margin. The analyses used Bayesian methodology. Should the posterior probability P (p1 - p0 \> -d \| data) be at least 0.95, then the null non-inferiority hypothesis will be rejected, and non-inferiority of the investigational device to the control will be claimed."||0.040|-0.013|1.000
72622763|NCT00637156|144775598|SUPERIORITY_OR_OTHER|||||||0.859||||||The posterior probability of superiority was calculated and presented instead of the p-value.|Bayesian model|||Superiority comparison of gait success rates in two treatment groups was performed if non-inferiority was demonstrated.||||0.859
72622764|NCT00637156|144775599|SUPERIORITY_OR_OTHER||Posterior Mean Difference|0.4||||0|TWO_SIDED|95.0|0.252|0.548||The posterior probably of superiority was calculated and presented instead of the p-value.|Bayesian model||The posterior mean difference (µ1- µ0) and the corresponding 95% highest posterior density (HPD) interval were presented instead of the usual 95% CI.|"Superiority comparison of the operative time in two treatment groups was assessed. The null hypothesis is H0: μ1 = μ0 and the alternative hypothesis is Ha: μ1 ≠ μ0, where μ0 and μ1 denote the mean in control group the investigational group, respectively. Should the posterior probability of superiority P(μ1- μ0 \< 0\|data) be at least 97.5%, the superiority would be claimed."||0.548|0.252|0.0
72471117|NCT01681992|144465854|NON_INFERIORITY|The lower limit of the 2-sided 97.5% CI on the group difference (Inv\_MMR\_Med minus Com\_MMR) in seroresponse rate should be ≥ -10% for antibodies to mumps virus when tested with PRNT.|Difference in seroresponse rate|-7.22|||||TWO_SIDED|97.5|-10.94|-3.49|||||Asymptotic standardized 97.5% CI for the difference in seroresponse rate.|Non-inferiority of Inv\_MMR\_Med vaccine compared to Com\_MMR vaccine in terms of seroresponse rate to mumps virus at Day 42.||-3.49|-10.94|
72395514|NCT02320149|144297463|SUPERIORITY||Least Squares Mean Difference|-16.7|||<|0.0001|TWO_SIDED|95.0|-21.9|-11.6||Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.|ANCOVA||sarecycline - placebo|Percent Change from Baseline to Week 12||-11.6|-21.9|< 0.0001
72471118|NCT01681992|144465855|NON_INFERIORITY|The lower limit of the 2-sided 97.5% CI on the group difference (Inv\_MMR\_Min minus Com\_MMR) in seroresponse rate should be ≥ -5% for antibodies to rubella virus when tested with ELISA.|Difference in seroresponse rate|-1.71|||||TWO_SIDED|97.5|-3.11|-0.42|||||Asymptotic standardized 97.5% CI for the difference in seroresponse rate.|Non-inferiority of Inv\_MMR\_Min vaccine compared to Com\_MMR vaccine in terms of seroresponse rate to rubella virus at Day 42.||-0.42|-3.11|
72471119|NCT01681992|144465855|NON_INFERIORITY|The lower limit of the 2-sided 97.5% CI on the group difference (Inv\_MMR\_Med minus Com\_MMR) in seroresponse rate should be ≥ -5% for antibodies to rubella virus when tested with ELISA.|Difference in seroresponse rate|-1.18|||||TWO_SIDED|97.5|-2.5|0.05|||||Asymptotic standardized 97.5% CI for the difference in seroresponse rate.|Non-inferiority of Inv\_MMR\_Med vaccine compared to Com\_MMR vaccine in terms of seroresponse rate to rubella virus at Day 42.||0.05|-2.50|
72622765|NCT00637156|144775600|SUPERIORITY_OR_OTHER||Posterior Mean Difference|11.5||||0.02|TWO_SIDED|95.0|0.56|22.44|||Bayesian model||The posterior mean difference (µ1- µ0) and the corresponding 95% highest posterior density (HPD) interval were presented instead of the usual 95% CI.|"Superiority comparison of the blood loss in two treatment groups was assessed.The null hypothesis is H0: μ1 = μ0 and the alternative hypothesis is Ha: μ1 ≠ μ0, where μ0 and μ1 denote the mean in control group the investigational group, respectively. Should the posterior probability of superiority P(μ1- μ0 \< 0\|data) be at least 97.5%, the superiority would be claimed."||22.440|0.560|0.02
72622766|NCT00637156|144775601|SUPERIORITY_OR_OTHER||Posterior Mean Difference|-0.1||||0.892|TWO_SIDED|95.0|-0.258|0.058||The posterior probably of superiority was calculated and presented instead of the p-value.|Bayesian model||The posterior mean difference (µ1- µ0) and the corresponding 95% highest posterior density (HPD) interval were presented instead of the usual 95% CI.|"Superiority comparison of the hospital stay in two treatment groups was assessed.The null hypothesis is H0: μ1 = μ0 and the alternative hypothesis is Ha: μ1 ≠ μ0, where μ0 and μ1 denote the mean in control group the investigational group, respectively. Should the posterior probability of superiority P(μ1- μ0 \< 0\|data) be at least 97.5%, the superiority would be claimed."||0.058|-0.258|0.892
72622767|NCT01308788|144775609|SUPERIORITY_OR_OTHER|||||||0.4414||95.0|||||ANCOVA|||||||.4414
72622768|NCT01308788|144775610|SUPERIORITY_OR_OTHER|||||||0.782||95.0|||||ANCOVA|||||||.7820
72622769|NCT01308788|144775611|SUPERIORITY_OR_OTHER|||||||0.5496||95.0|||||ANCOVA|||||||.5496
72622770|NCT01308788|144775612|SUPERIORITY_OR_OTHER|||||||0.293||95.0|||||ANCOVA|||||||.2930
72622771|NCT01308788|144775613|SUPERIORITY_OR_OTHER|||||||0.5058||95.0|||||ANCOVA|||||||.5058
72622772|NCT01308788|144775614|SUPERIORITY_OR_OTHER|||||||0.6156||95.0|||||ANCOVA|||||||.6156
72622773|NCT01308788|144775615|SUPERIORITY_OR_OTHER|||||||0.5443||95.0|||||ANCOVA|||||||.5443
72622774|NCT01308788|144775616|SUPERIORITY_OR_OTHER|||||||0.7847||95.0|||||ANCOVA|||||||.7847
72622775|NCT01308788|144775617|SUPERIORITY_OR_OTHER|||||||0.1331||95.0|||||ANCOVA|||||||.1331
72622776|NCT01308788|144775618|SUPERIORITY_OR_OTHER|||||||0.5431||95.0|||||ANCOVA|||||||.5431
72622777|NCT01308788|144775619|SUPERIORITY_OR_OTHER|||||||0.0684||95.0|||||ANCOVA|||||||.0684
72622778|NCT01308788|144775620|SUPERIORITY_OR_OTHER|||||||0.25||95.0|||||ANCOVA|||||||.2500
72622779|NCT01308788|144775621|SUPERIORITY_OR_OTHER|||||||0.6896||95.0|||||ANCOVA|||||||.6896
72622780|NCT01308788|144775622|SUPERIORITY_OR_OTHER|||||||0.7965||95.0|||||ANCOVA|||||||.7965
72622781|NCT04632030|144775667|OTHER||Odds Ratio (OR)|1.58|||||TWO_SIDED|95.0|0.69|3.6|||||Adjusted for age, education, and lifetime tobacco use|||3.6|.69|
72622782|NCT04632030|144775667|OTHER||Odds Ratio (OR)|2.89|||||TWO_SIDED|95.0|1.28|6.55|||||Adjusted for age, education, and lifetime tobacco use|||6.55|1.28|
72622783|NCT04632030|144775668|OTHER||Odds Ratio (OR)|2.88|||||TWO_SIDED|95.0|1.28|6.47|||||Adjusted for age, education, and lifetime tobacco use|||6.47|1.28|
72622784|NCT04632030|144775668|OTHER||Odds Ratio (OR)|2.87|||||TWO_SIDED|95.0|1.26|6.5|||||Adjusted for age, education, and lifetime tobacco use|||6.50|1.26|
72622785|NCT04632030|144775669|OTHER||Odds Ratio (OR)|1.51|||||TWO_SIDED|95.0|0.59|3.86|||||Adjusted for age, education, and lifetime tobacco use|||3.86|.59|
72622786|NCT04632030|144775669|OTHER||Odds Ratio (OR)|1.85|||||TWO_SIDED|95.0|0.73|4.67|||||Adjusted for age, education, and lifetime tobacco use|||4.67|.73|
72622787|NCT04632030|144775670|OTHER||Odds Ratio (OR)|1.25|||||TWO_SIDED|95.0|0.53|2.99|||||Adjusted for age, education, and lifetime tobacco use|||2.99|.53|
72622788|NCT04632030|144775670|OTHER||Odds Ratio (OR)|2.19|||||TWO_SIDED|95.0|0.94|5.13|||||Adjusted for age, education, and lifetime tobacco use|||5.13|.94|
72622789|NCT00964678|144775671|SUPERIORITY|||||||0.028|TWO_SIDED|20.0||||The threshold for statistical significance was p=0.05.|ANOVA|||||||0.028
72622790|NCT00964678|144775672|SUPERIORITY|||||||0.028||||||The threshold for statistical significance was p=0.05.|ANOVA|||||||0.028
72622791|NCT00964678|144775673|SUPERIORITY||||||>|0.05|TWO_SIDED|20.0||||The threshold for statistical significance was p=0.05.|ANOVA|||||||>0.05
72622792|NCT00964678|144775674|SUPERIORITY||||||>|0.05|TWO_SIDED|20.0|||||ANOVA|||||||>0.05
72622793|NCT03443401|144775725|SUPERIORITY||Mean Difference (Net)|80.0||||0.004|TWO_SIDED|||||level of significance at \<0.05|Spearman's rho|||||||0.004
72622794|NCT03443401|144775726|SUPERIORITY||Mean Difference (Net)|80.0||||0.027|TWO_SIDED|||||Level of significance \<0.05|Spearman's rho|||||||0.027
72622795|NCT02254460|144775728|SUPERIORITY_OR_OTHER||[Treatment difference]|1.74||||0.0944|TWO_SIDED|95.0|0.9|3.34|||ANOVA||Treatment difference from ANOVA of log transformed data. Back transformed data are presented. This therefore represents the iron absorption ratio of the Micronutrient Fortified Drink (Test) to the Non-Fortified Drink (Control).|||3.34|0.90|0.0944
72622796|NCT00137449|144775729|SUPERIORITY_OR_OTHER||CBR Rate (percentage)|50.0||||||95.0|31.3|68.7|||F distribution|||||68.7|31.3|
72622797|NCT00137449|144775729|SUPERIORITY_OR_OTHER||CBR Rate (percentage)|56.7||||||95.0|37.4|74.5|||F distribution|||||74.5|37.4|
72622798|NCT00137449|144775729|SUPERIORITY_OR_OTHER||CBR Rate (percentage)|53.3||||||95.0|40.0|66.3|||F distribution|||Null hypothesis that the true CBR \<=20% vs the alternative hypothesis that the true clinical benefit rate is at least 35%. The sample size is determined using a single-stage design with an alpha level of 10% \& 90% power. If \>=17 CR, PR or SD for at least 24 weeks are observed, null hypothesis can be rejected with a 20% target false positive error rate. If \<= 16 CR, PR,or SD for at least 24 weeks are observed, null hypothesis can not be rejected with a target false negative error rate of 10%.||66.3|40.0|
72622799|NCT00137449|144775731|SUPERIORITY_OR_OTHER||ORR rate (percentage)|10.0||||||95.0|2.1|26.5|||F distribution||PR or CR responding tumor measurements confirmed by repeat studies performed at \> 4 weeks after the criteria for response first met.|||26.5|2.1|
72622800|NCT00137449|144775731|SUPERIORITY_OR_OTHER||ORR rate (percentage)|16.7||||||95.0|5.6|34.7|||F distribution||PR or CR responding tumor measurements confirmed by repeat studies performed at \> 4 weeks after the criteria for response first met.|||34.7|5.6|
72622801|NCT00137449|144775731|SUPERIORITY_OR_OTHER||ORR rate (percentage)|13.3||||||95.0|5.9|24.6|||F distribution||PR or CR responding tumor measurements confirmed by repeat studies performed at \> 4 weeks after the criteria for response first met.|||24.6|5.9|
72622802|NCT00137449|144775733|SUPERIORITY_OR_OTHER||median|27.0||||||95.0|22.0|73.1|||Kaplan-Meier method|||95% CI calculated based on the method of Brookmeyer and Crowley. Median reported is progression free survival weeks.||73.1|22.0|
72471120|NCT01681992|144465856|NON_INFERIORITY|The lower limit of the 2-sided 97.5% CI on the group ratio of GMCs (Inv\_MMR\_Min over pooled Com\_MMR) should to be ≥ 0.67 for antibodies to measles virus when tested with ELISA.|Adjusted GMC ratio|0.79|||||TWO_SIDED|97.5|0.72|0.88|||ANOVA|97.5% CI for GMC ratio was computed using ANOVA model on the log-transformed concentrations with vaccine group and the country as fixed effects.||Non-inferiority of Inv\_MMR\_Min vaccine compared to COM\_MMR vaccine in terms of GMCs for anti-measles antibodies at Day 42.||0.88|0.72|
72471121|NCT01681992|144465856|NON_INFERIORITY|The lower limit of the 2-sided 97.5% CI on the group ratio of GMCs (Inv\_MMR\_Med over pooled Com\_MMR) should to be ≥ 0.67 for antibodies to measles virus when tested with ELISA.|Adjusted GMC ratio|0.91|||||TWO_SIDED|97.5|0.83|1.01|||ANOVA|97.5% CI for GMC ratio was computed using ANOVA model on the log-transformed concentrations with vaccine group and the country as fixed effects.||Non-inferiority of Inv\_MMR\_Med vaccine compared to COM\_MMR vaccine in terms of GMCs for anti-measles antibodies at Day 42.||1.01|0.83|
72471122|NCT01681992|144465857|NON_INFERIORITY|The lower limit of the 2-sided 97.5% CI on the group ratio of GMCs (Inv\_MMR\_Min over pooled Com\_MMR) should to be ≥ 0.67 for antibodies to mumps virus when tested with ELISA.|Adjusted GMC ratio|0.82|||||TWO_SIDED|97.5|0.76|0.89|||ANOVA|97.5% CI for GMC ratio was computed using ANOVA model on the log-transformed concentrations with vaccine group and the country as fixed effects.||Non-inferiority of Inv\_MMR\_Min vaccine compared to COM\_MMR vaccine in terms of GMCs for anti-mumps antibodies at Day 42.||0.89|0.76|
72471123|NCT01681992|144465857|NON_INFERIORITY|The lower limit of the 2-sided 97.5% CI on the group ratio of GMCs (Inv\_MMR\_Med over pooled Com\_MMR) should to be ≥ 0.67 for antibodies to mumps virus when tested with ELISA.|Adjusted GMC ratio|0.84|||||TWO_SIDED|97.5|0.78|0.91|||ANOVA|97.5% CI for GMC ratio was computed using ANOVA model on the log-transformed concentrations with vaccine group and the country as fixed effects.||Non-inferiority of Inv\_MMR\_Med vaccine compared to COM\_MMR vaccine in terms of GMCs for anti-mumps antibodies at Day 42.||0.91|0.78|
72471124|NCT01681992|144465858|NON_INFERIORITY|The lower limit of the 2-sided 97.5% CI on the group ratio of GMCs (Inv\_MMR\_Min over pooled Com\_MMR) should to be ≥ 0.67 for antibodies to mumps virus when tested with PRNT.|Adjusted GMT ratio|0.6|||||TWO_SIDED|97.5|0.53|0.68|||ANOVA|97.5% CI for GMC ratio was computed using ANOVA model on the log-transformed titers with vaccine group and the country as fixed effects.||Non-inferiority of Inv\_MMR\_Min vaccine compared to COM\_MMR vaccine in terms of GMCs for anti-mumps antibodies at Day 42.||0.68|0.53|
72471125|NCT01681992|144465858|NON_INFERIORITY|The lower limit of the 2-sided 97.5% CI on the group ratio of GMCs (Inv\_MMR\_Med over pooled Com\_MMR) should to be ≥ 0.67 for antibodies to mumps virus when tested with PRNT.|Adjusted GMT ratio|0.65|||||TWO_SIDED|97.5|0.57|0.74|||ANOVA|97.5% CI for GMC ratio was computed using ANOVA model on the log-transformed titers with vaccine group and the country as fixed effects.||Non-inferiority of Inv\_MMR\_Med vaccine compared to COM\_MMR vaccine in terms of GMCs for anti-mumps antibodies at Day 42.||0.74|0.57|
72471126|NCT01681992|144465859|NON_INFERIORITY|The lower limit of the 2-sided 97.5% CI on the group ratio of GMCs (Inv\_MMR\_Min over pooled Com\_MMR) should to be ≥ 0.67 for antibodies to rubella virus when tested with ELISA.|Adjusted GMC ratio|0.89|||||TWO_SIDED|97.5|0.83|0.95|||ANOVA|97.5% CI for GMC ratio was computed using ANOVA model on the log-transformed concentrations with vaccine group and the country as fixed effects.||Non-inferiority of Inv\_MMR\_Min vaccine compared to COM\_MMR vaccine in terms of GMCs for anti-rubella antibodies at Day 42.||0.95|0.83|
72471127|NCT01681992|144465859|NON_INFERIORITY|The lower limit of the 2-sided 97.5% CI on the group ratio of GMCs (Inv\_MMR\_Med over pooled Com\_MMR) should to be ≥ 0.67 for antibodies to rubella virus when tested with ELISA.|Adjusted GMC ratio|0.88|||||TWO_SIDED|97.5|0.83|0.95|||ANOVA|97.5% CI for GMC ratio was computed using ANOVA model on the log-transformed concentrations with vaccine group and the country as fixed effects.||Non-inferiority of Inv\_MMR\_Med vaccine compared to COM\_MMR vaccine in terms of GMCs for anti-rubella antibodies at Day 42.||0.95|0.83|
72471128|NCT03274895|144465969|NON_INFERIORITY|Non-inferiority margin= 0.20|difference in proportion of resolution r|-0.036|||||TWO_SIDED|95.0|-0.154|0.081||||||||0.081|-0.154|
72471129|NCT03274895|144465970|OTHER|||||||0.042|||||||Log Rank|||||||0.042
72471130|NCT03274895|144465971|OTHER|||||||0.577|||||||ANCOVA|||||||0.577
72471131|NCT00401258|144465973|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Mixed Models Analysis|||||||<0.001
72471132|NCT00401258|144465974|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Mixed Models Analysis|||Average pain severity statistical analysis||||<.001
72471133|NCT00401258|144465974|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Mixed Models Analysis|||Average pain interference statistical analysis||||<.001
72471134|NCT00401258|144465975|SUPERIORITY_OR_OTHER|||||||0.001|||||||Mixed Models Analysis|||||||.001
72471135|NCT00401258|144465976|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
72471136|NCT00401258|144465978|SUPERIORITY_OR_OTHER|||||||0.031|||||||Mixed Models Analysis|||||||0.031
72471137|NCT00401258|144465979|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
72471138|NCT00401258|144465980|SUPERIORITY_OR_OTHER|||||||0.004||||||Refers to work/school sub-scale|Mixed Models Analysis|||||||0.004
72471139|NCT00401258|144465980|SUPERIORITY_OR_OTHER|||||||0.087||||||Refers to social sub scale|Mixed Models Analysis|||||||0.087
72471140|NCT00401258|144465980|SUPERIORITY_OR_OTHER|||||||0.006||||||Refers to family sub scale|Mixed Models Analysis|||||||0.006
72471141|NCT05672771|144465992|SUPERIORITY||Mean Difference (Final Values)|0.38||||0.355|TWO_SIDED||||||ANOVA|||||||0.355
72471142|NCT05672771|144465993|SUPERIORITY||Mean Difference (Final Values)|0.56|||<|0.02|TWO_SIDED||||||ANOVA||This is the difference between the Different Mixed and Placebo Control conditions.|||||<.02
72471143|NCT05672771|144465994|OTHER||||||<|0.05||||||for contrasts of DM, DS, and ST groups relative to the PC group.|Mixed Models Analysis|||||||<.05
72471144|NCT00760747|144465995|SUPERIORITY_OR_OTHER||Least square mean differences at week 10|-0.7|STANDARD_ERROR_OF_MEAN|1.7||0.692|TWO_SIDED|95.0|-4.0|2.6|||Mixed Models Analysis|||||2.6|-4.0|0.692
72471145|NCT00760747|144465996|SUPERIORITY_OR_OTHER||Least square mean differences at week 10|0.2|STANDARD_ERROR_OF_MEAN|0.2||0.456|TWO_SIDED|95.0|-0.3|0.7|||Mixed Models Analysis|||||0.7|-0.3|0.456
72471146|NCT00760747|144465997|SUPERIORITY_OR_OTHER||Least square mean differences at week 10|0.2|STANDARD_ERROR_OF_MEAN|0.3||0.517|TWO_SIDED|95.0|-0.3|0.7|||Mixed Models Analysis|||||0.7|-0.3|0.517
72471147|NCT00760747|144465998|SUPERIORITY_OR_OTHER||Least square mean differences at week 10|0.1|STANDARD_ERROR_OF_MEAN|0.2||0.526|TWO_SIDED|95.0|-0.3|0.6|||Mixed Models Analysis|||||0.6|-0.3|0.526
72622803|NCT00137449|144775733|SUPERIORITY_OR_OTHER||median|35.1||||||95.0|24.4|51.6|||Kaplan-Meier method|||95% CI calculated based on the method of Brookmeyer and Crowley.Median reported is progression free survival weeks.||51.6|24.4|
72471148|NCT00760747|144465999|SUPERIORITY_OR_OTHER||Least square mean differences at week 10|0.0|STANDARD_ERROR_OF_MEAN|0.2||0.898|TWO_SIDED|95.0|-0.4|0.4|||Mixed Models Analysis|||||0.4|-0.4|0.898
72471149|NCT00760747|144466004|SUPERIORITY_OR_OTHER||Least square mean differences at week 2|-0.1|STANDARD_ERROR_OF_MEAN|1.4||0.927|TWO_SIDED|95.0|-2.9|2.6|||Mixed Models Analysis|||||2.6|-2.9|0.927
72471150|NCT00455741|144466046|SUPERIORITY_OR_OTHER|||||||0.9|||||||ANOVA|||effect of age on estrogen negative feedback ( nadir LH as % of baseline LH)||||0.90
72471151|NCT00455741|144466046|SUPERIORITY||||||<|0.03||||||a priori threshold for significance is p\<0.05|ANOVA|||positive feedback||||<0.03
72471152|NCT00455741|144466047|SUPERIORITY||||||=|0.03||||||a priori significance level p\<0.05|ANOVA|||||||=0.03
72471153|NCT00455741|144466048|SUPERIORITY|||||||0.49||||||threshold for significance p\<0.05|t-test, 2 sided|||||||0.49
72471154|NCT00455741|144466049|SUPERIORITY||||||<|0.02||||||a priori threshold for significance p\<0.05|t-test, 2 sided|||||||<0.02
72471155|NCT00455741|144466050|SUPERIORITY||||||<|0.03|||||||t-test, 2 sided|||||||<0.03
72471156|NCT00455741|144466051|SUPERIORITY|||||||0.07||||||a priori significance set at p\<0.05|t-test, 2 sided|||||||0.07
72471157|NCT00935532|144466095|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority of exenatide QW to insulin glargine with respect to change in HbA1c was to be concluded if the upper limit of the 95% confidence interval (CI) for the treatment difference was less than 0.4%. Change in HbA1c from baseline to endpoint was analyzed using a LOCF ANCOVA model with treatment, baseline HbA1c stratum (\<8.5%, \>=8.5%), background OAD, and presence/absence of pretreatment with SU as factors and baseline HbA1c as a covariate.|Least Squares Mean Difference|-0.43|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-0.59|-0.26||No adjustments for multiplicity will be performed|ANCOVA|||The expected changes in HbA1c from baseline were considered to be the same between the groups, and the common standard deviation assumed to be 1.2%. Assuming a type I error of 0.025 (one-sided), a power of 0.9 and a noninferiority margin of 0.4%, 191 subjects per group would be necessary to confirm the noninferiority by the two-sample t-test. When the proportion of the subjects missing post-baseline data was assumed to be 10%, the target number of subjects were 420 in total (210 subjects/group).||-0.26|-0.59|<.001
72471158|NCT00935532|144466096|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|95.0|||||Cochran-Mantel-Haenszel|||Percentage of subjects achieving HbA1c\<=7% at endpoint were compared between treatments using a Cochran-Mantel-Haenszel (CMH) test, in which background OAD and presence/absence of pretreatment with SU served as the stratification factors.||||<.001
72471159|NCT00935532|144466097|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|95.0|||||Cochran-Mantel-Haenszel|||Percentage of subjects achieving HbA1c\<=6.5% at endpoint were compared between treatments using a CMH test, in which background OAD and presence/absence of pretreatment with SU served as the stratification factors.||||<.001
72622804|NCT00137449|144775733|SUPERIORITY_OR_OTHER||median|33.6||||||95.0|24.1|49.0|||Kaplan-Meier method|||95% CI calculated based on the method of Brookmeyer and Crowley.Median reported is progression free survival weeks.||49.0|24.1|
72471160|NCT00935532|144466098|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-5.28|STANDARD_ERROR_OF_MEAN|3.23||0.103|TWO_SIDED|95.0|-11.62|1.07|||ANCOVA|||Change in FSG from baseline to endpoint was analyzed using a LOCF ANCOVA model with treatment, background OAD, and presence/absence of pretreatment with SU as factors and baseline FSG as a covariate.||1.07|-11.62|0.103
72622805|NCT00137449|144775734|SUPERIORITY_OR_OTHER||median|57.0||||||95.0|24.1|73.1|||Kaplan-Meier method|||95% CI calculated based on the method of Brookmeyer and Crowley.Time to progression in weeks reported as median.||73.1|24.1|
72471161|NCT00935532|144466099|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-2.01|STANDARD_ERROR_OF_MEAN|0.23|<|0.001|TWO_SIDED|95.0|-2.46|-1.56|||ANCOVA|||Change in body weight from baseline to endpoint was analyzed using a LOCF ANCOVA model with treatment, background OAD, and presence/absence of pretreatment with SU as factors and baseline body weight as a covariate.||-1.56|-2.46|<.001
72471162|NCT00935532|144466100|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-7.89|STANDARD_ERROR_OF_MEAN|2.26|<|0.001|TWO_SIDED|95.0|-12.33|-3.45|||ANCOVA|||Change in total cholesterol from baseline to endpoint was analyzed using a LOCF ANCOVA model with treatment, background OAD, and presence/absence of pretreatment with SU as factors and baseline total cholesterol as a covariate.||-3.45|-12.33|<.001
72471163|NCT00935532|144466101|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.28|STANDARD_ERROR_OF_MEAN|0.69||0.689|TWO_SIDED|95.0|-1.64|1.09|||ANCOVA|||Change in HDL-C from baseline to endpoint was analyzed using a LOCF ANCOVA model with treatment, background OAD, and presence/absence of pre-treatment with SU as factors and baseline HDL-C as a covariate.||1.09|-1.64|0.689
72471164|NCT00935532|144466102|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean Ratio|1.0|STANDARD_ERROR_OF_MEAN|1.03||0.99|TWO_SIDED|95.0|0.94|1.06|||ANCOVA|||Triglycerides data were logarithm-transformed and the change at endpoint to baseline, expressed as the ratio, was analyzed using a LOCF ANCOVA model with treatment, background OAD, and presence/absence of pretreatment with SU as factors and baseline triglycerides as a covariate.||1.06|0.94|0.990
72471165|NCT04954326|144466106|EQUIVALENCE|The 90% Confidence Interval of the geometric mean ratios of the Lyophilisate compared to the Liquid formulations for AUCinf should be completely contained within the predefined \[80.00%-125.00%\] equivalence interval.|Geometric Mean Ratio (%)|102.8||||0.05|TWO_SIDED|90.0|91.4|115.6|||ANOVA|||AUCinf was natural log-transformed and analyzed using an analysis of variance (ANOVA) with fixed effect for formulation. The two one-sided tests procedures were performed on the geometric mean ratio (GMR) between test (S95014 lyophilizate) and reference (S95014 liquid formulation) treatments. The 90% confidence interval for the ratio was obtained within the framework of the ANOVA.||115.6|91.4|0.05
72471166|NCT04954326|144466107|EQUIVALENCE|The 90% Confidence Interval of the geometric mean ratios of the Lyophilisate compared to the Liquid formulations for Cmax should be completely contained within the predefined \[80.00%-125.00%\] equivalence interval.|Geometric Mean Ratio (%)|93.5||||0.05|TWO_SIDED|90.0|82.9|105.5|||ANOVA|||Cmax was natural log-transformed and analyzed using an analysis of variance (ANOVA) with fixed effect for formulation. The two one-sided tests procedures were performed on the geometric mean ratio (GMR) between test (S95014 lyophilizate) and reference (S95014 liquid formulation) treatments. The 90% confidence interval for the ratio was obtained within the framework of the ANOVA.||105.5|82.9|0.05
72505475|NCT01334125|144542058|SUPERIORITY_OR_OTHER|||||||0.903|TWO_SIDED|||||Individual two-way mixed ANOVA models were fitted for each of our outcomes of interest, with treatment type (metformin or placebo) as the fixed effect, and baseline values, age, gender, and BMI as covariates.|ANOVA|||Analyses were based on the intent-to-treat principle and were performed using SPSS v.22 (IBM Corporation, Armonk, NY).||||0.903
72505476|NCT01334125|144542059|SUPERIORITY_OR_OTHER|||||||0.578|TWO_SIDED|95.0||||Individual two-way mixed ANOVA models were fitted for each of our outcomes of interest, with treatment type (metformin or placebo) as the fixed effect, and baseline values, age, gender, and BMI as covariates.|ANOVA|||Analyses were based on the intent-to-treat principle and were performed using SPSS v.22 (IBM Corporation, Armonk, NY).||||0.578
72622806|NCT00137449|144775734|SUPERIORITY_OR_OTHER||median|42.1||||||95.0|26.1|65.9|||Kaplan-Meier method|||95% CI calculated based on the method of Brookmeyer and Crowley.Time to progression in weeks reported as median.||65.9|26.1|
72622807|NCT00137449|144775734|SUPERIORITY_OR_OTHER||median|42.1||||||95.0|26.1|65.9|||Kaplan-Meier method|||95% CI calculated based on the method of Brookmeyer and Crowley.Time to progression in weeks reported as median.||65.9|26.1|
72622808|NCT00137449|144775736|SUPERIORITY_OR_OTHER||1 year survival rate|60.0||||||95.0|40.5|75.0|||Kaplan-Meier method|||||75.0|40.5|
72395515|NCT02320149|144297464|SUPERIORITY||Least Squares Mean Difference|-12.5|||<|0.0001||95.0|-16.9|-8.0||Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.|ANCOVA||sarecycline - placebo|Percent Change from Baseline to Week 9||-8.0|-16.9|< 0.0001
72505477|NCT01334125|144542060|SUPERIORITY_OR_OTHER|||||||0.057|||||||ANOVA|||Two way ANOVA comparison of the means of the adiponectin/leptin ratios between the metformin and placebo groups||||0.057
72505478|NCT01334125|144542061|SUPERIORITY_OR_OTHER|||||||1|||||||t-test, 2 sided|||p value represents the analysis for minor hypoglycemia||||1.00
72505479|NCT01334125|144542061|SUPERIORITY_OR_OTHER|||||||1|||||||t-test, 2 sided|||p value represents the analysis of the nocturnal hypoglycemia||||1.00
72505480|NCT00641043|144542064|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.51|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001||95.0|-0.71|-0.3|||ANCOVA|||Linagliptin vs. Placebo||-0.30|-0.71|<0.0001
72505481|NCT00641043|144542065|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.38|STANDARD_ERROR_OF_MEAN|0.07|<|0.0001||95.0|-0.52|-0.24|||ANCOVA|||Linagliptin vs. Placebo||-0.24|-0.52|<0.0001
72505482|NCT00641043|144542066|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001||95.0|-0.67|-0.32|||ANCOVA|||Linagliptin vs. Placebo||-0.32|-0.67|<0.0001
72505483|NCT00641043|144542067|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.51|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001||95.0|-0.7|-0.32|||ANCOVA|||Linagliptin vs. Placebo||-0.32|-0.70|<0.0001
72505484|NCT00641043|144542068|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.2|STANDARD_ERROR_OF_MEAN|3.5|<|0.0001||95.0|-21.1|-7.3|||ANCOVA|||Linagliptin vs. Placebo||-7.3|-21.1|<0.0001
72505485|NCT00641043|144542069|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.4|STANDARD_ERROR_OF_MEAN|3.0|<|0.0001||95.0|-22.3|-10.5|||ANCOVA|||Linagliptin vs. Placebo||-10.5|-22.3|<0.0001
72505486|NCT00641043|144542070|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.2|STANDARD_ERROR_OF_MEAN|3.2|<|0.0001||95.0|-19.5|-7.0|||ANCOVA|||Linagliptin vs. Placebo||-7.0|-19.5|<0.0001
72505487|NCT00641043|144542071|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.9|STANDARD_ERROR_OF_MEAN|3.4|<|0.0001||95.0|-20.5|-7.3|||ANCOVA|||Linagliptin vs. Placebo||-7.3|-20.5|<0.0001
72505488|NCT00641043|144542072|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.103||||0.0051||95.0|1.25|3.539|||Regression, Logistic|||"Linagliptin vs. Placebo~The odds-ratio is based on a logistic regression model including baseline HbA1c and previous antidiabetes medication."||3.539|1.25|0.0051
72505489|NCT00641043|144542074|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.348||||0.3547||95.0|0.716|2.537|||Regression, Logistic|||"Linagliptin vs. Placebo~The odds-ratio is based on a logistic regression model including baseline HbA1c and previous antidiabetes medication."||2.537|0.716|0.3547
72505490|NCT00641043|144542076|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.823|||<|0.0001||95.0|2.286|6.394|||Regression, Logistic|||"Linagliptin vs. Placebo~The odds-ratio is based on a logistic regression model including baseline HbA1c and previous antidiabetes medication."||6.394|2.286|<0.0001
72505491|NCT03136705|144542094|SUPERIORITY||trend analysis|1.009||||0.3738|TWO_SIDED|95.0|0.989|1.031|||Mixed Models Analysis|||linear mixed model for repeated measures data||1.031|0.989|0.3738
72505492|NCT03136705|144542095|SUPERIORITY||trend analysis|0.0043||||0.854|TWO_SIDED|95.0|-0.0414|0.0499|||Mixed Models Analysis|||linear mixed model for repeated measures data||0.0499|-0.0414|0.854
72505493|NCT03136705|144542096|SUPERIORITY||trend analysis|20.38||||0.0648|TWO_SIDED|95.0|-1.26|42.03|||Mixed Models Analysis|||linear mixed model for repeated measures data||42.03|-1.26|0.0648
72505494|NCT04655586|144542116|SUPERIORITY|||||||0.4715||||||All rNAPc2 vs. Heparin|Wilcoxon Rank Sum|||All rNAPc2 doses (lower and higher) were pooled and compared to Heparin for statistical analysis presentation.||||0.4715
72505495|NCT04655586|144542117|SUPERIORITY|||||||0.1883|||||||Wilcoxon Rank Sum|||All rNAPc2 doses (lower and higher) were pooled and compared to Heparin for statistical analysis presentation.||||0.1883
72505496|NCT04655586|144542120|SUPERIORITY|||||||1|||||||Wilcoxon Rank Sum|||All rNAPc2 doses (lower and higher) were pooled and compared to Heparin for statistical analysis presentation.||||1.0
72505497|NCT04655586|144542121|SUPERIORITY|||||||0.0254|||||||Wilcoxon Rank Sum|||All rNAPc2 doses (lower and higher) were pooled and compared to Heparin for statistical analysis presentation.||||0.0254
72505498|NCT04655586|144542122|SUPERIORITY|||||||0.0535|||||||Wilcoxon Rank Sum|||All rNAPc2 doses (lower and higher) were pooled and compared to Heparin for statistical analysis presentation.||||0.0535
72505499|NCT04655586|144542123|SUPERIORITY|||||||0.83|||||||Wilcoxon Rank Sum|||All rNAPc2 doses (lower and higher) were pooled and compared to Heparin for statistical analysis presentation.||||0.8300
72505500|NCT00201201|144542127|SUPERIORITY_OR_OTHER|||||||0.035||95.0|||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel statistic (1,161)=4.44,p=0.035).||Repeated measures linear-mixed model ANOVA methodology was employed as each participant was measured on 4 visits and the 4 repeated measures are likely dependent. We used study group (intervention vs. control) and visit as categorical variables and controlled for gender, age, APRN, income, education, computer use. Non-parametric tests (Cochran-Mantel-Haenszel statistic), based on rank scores, controlling for participant code were used for the transformed behavior risk scores within groups.||||0.035
72622809|NCT00137449|144775736|SUPERIORITY_OR_OTHER||1 year survival rate|79.7||||||95.0|60.3|90.3|||Kaplan-Meier method|||||90.3|60.3|
72505501|NCT00201201|144542128|SUPERIORITY_OR_OTHER|||||||0.0204||95.0|||||ANOVA|||Repeated measures linear-mixed model ANOVA methodology was employed as each participant was measured on 4 visits and the 4 repeated measures are likely dependent. We used study group (intervention vs. control) and visit as categorical variables and controlled for gender, age, APRN, income, education, computer use.||||.0204
72505502|NCT00201201|144542129|SUPERIORITY_OR_OTHER|||||||0.0001||95.0|||||ANOVA|||Repeated measures linear-mixed model ANOVA methodology was employed as each participant was measured on 4 visits and the 4 repeated measures are likely dependent. We used study group (intervention vs. control) and visit as categorical variables and controlled for gender, age, APRN, income, education, computer use.||||.0001
72505503|NCT00201201|144542130|SUPERIORITY_OR_OTHER|||||||0.0001||95.0|||||ANOVA|||Repeated measures linear-mixed model ANOVA methodology was employed as each participant was measured on 4 visits and the 4 repeated measures are likely dependent. We used study group (intervention vs. control) and visit as categorical variables and controlled for gender, age, APRN, income, education, computer use.||||0.0001
72505504|NCT00201201|144542131|SUPERIORITY_OR_OTHER|||||||0.0431||95.0|||||t-test, 2 sided|||||||0.0431
72505505|NCT00201201|144542132|SUPERIORITY_OR_OTHER||||||<|0.1||95.0|||||t-test, 2 sided|||Analyzed at 0 and 12 weeks.||||<.10
72505506|NCT01342640|144542137|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Paired t-test|||Change from baseline in mean Hb levels at Week 20 was analyzed using paired t-test.||||<0.0001
72505507|NCT01342640|144542138|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Paired t-test|||Change from baseline in mean Hb levels at Week 24 was analyzed using paired t-test.||||<.0001
72505508|NCT01342640|144542139|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Paired t-test|||Change from baseline in mean Hb levels at Week 28 was analyzed using paired t-test.||||<.0001
72622810|NCT00137449|144775736|SUPERIORITY_OR_OTHER||1 year survival rate|69.7||||||95.0|56.3|79.7|||Kaplan-Meier method|||||79.7|56.3|
72622811|NCT01356940|144775740|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.586||||0.586|TWO_SIDED||||||Mixed Models Analysis||P values above 0.05 are considered statistically not significant in this study|||||0.586
72622812|NCT02489279|144775742|SUPERIORITY|||||||0.026|||||||GLM with repeated measures ANOVA|||We used a General Linear Model (GLM) with time (Baseline and 10 Weeks) as the within subjects factor, experimental group (Active and Control) as the between subjects factor, and a group by time interaction to test for differential treatment effects. We report the Group x Time interaction.||||0.026
72505509|NCT01745055|144542140|SUPERIORITY_OR_OTHER||Ratio of Adjusted Geometric Means|103.06|||||TWO_SIDED|90.0|99.0|107.29||||||Natural log transformed, AUC (0-12) of CP-690,550 was analyzed using mixed effect model with treatment as fixed effects and participant as a random effect. The adjusted mean differences and 90% confidence intervals (CIs) for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||107.29|99.00|
72505510|NCT01745055|144542141|SUPERIORITY_OR_OTHER||Ratio of Adjusted Geometric Means|102.71|||||TWO_SIDED|90.0|93.79|112.47||||||Natural log transformed, Cmax of CP-690,550 was analyzed using mixed effect model with treatment as fixed effects and participant as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||112.47|93.79|
72505511|NCT01745055|144542142|SUPERIORITY_OR_OTHER||Ratio of Adjusted Geometric Means|89.53|||||TWO_SIDED|90.0|77.38|103.57||||||Natural log transformed, AUClast of MTX was analyzed using mixed effect model with treatment as fixed effects and participant as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||103.57|77.38|
72505512|NCT01745055|144542143|SUPERIORITY_OR_OTHER||Ratio of Adjusted Geometric Means|87.25|||||TWO_SIDED|90.0|76.03|100.12||||||Natural log transformed, Cmax of MTX was analyzed using mixed effect model with treatment as fixed effects and participant as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||100.12|76.03|
72622813|NCT02489279|144775742|SUPERIORITY|||||||0.0075|||||||t-test, 1 sided|||We then examined the within-subjects factor of Time (Post-Treatment (10 week measure) - Baseline), for each Group, using a 1-tailed t test.||||0.0075
72505513|NCT01720667|144542167|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||Comparison of 24 hour seizure termination rates using a Fisher's exact test.||||<0.001
72505514|NCT01720667|144542168|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||Comparison of seizure cessation at 48 hours using Fisher's exact test||||<0.001
72505515|NCT03472534|144542177|OTHER|The p-value for the overall F-test was used to determine if the mean irritation scores were equal for all four products.|||||<|0.0001|||||||Fisher Exact|||||||<0.0001
72505516|NCT01221233|144542230|SUPERIORITY||Median Difference (Final Values)|17.6||||1|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||1.000
72505517|NCT00611455|144542234|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.86|||<|0.001|TWO_SIDED|95.0|1.67|4.91|||Cochran-Mantel-Haenszel|||||4.91|1.67|<0.001
72505518|NCT04382651|144542305|SUPERIORITY||Mean Difference (Final Values)|0.98|STANDARD_ERROR_OF_MEAN|2.225||0.33|TWO_SIDED|90.0|-2.7|4.7||1-Sided|ANCOVA|||||4.7|-2.7|0.33
72505519|NCT01507545|144542311|SUPERIORITY||Hazard Ratio (HR)|1.13||||0.7335|TWO_SIDED|95.0|0.76|1.67|||One-sided log-rank test|||||1.67|0.76|0.7335
72505520|NCT01507545|144542312|SUPERIORITY||Hazard Ratio (HR)|1.43||||0.9498|TWO_SIDED|95.0|0.93|2.19|||One-sided log-rank test|||||2.19|0.93|0.9498
72622814|NCT02489279|144775742|SUPERIORITY|||||||0.25|||||||t-test, 1 sided|||We then examined the within-subjects factor of Time (Post-Treatment (10 week measure) - Baseline), for each Group, using a 1-tailed t test.||||0.25
72622815|NCT02489279|144775743|SUPERIORITY|||||||0.014|||||||GLM with repeated measures ANOVA|||We used a GLM with time (Baseline and 10 Weeks) as the within subjects factor, experimental group (Active and Control) as the between subjects factor, and a group by time interaction to test for differential treatment effects. We report the Group x Time interaction.||||0.014
72622816|NCT02489279|144775743|SUPERIORITY|||||||0.0005|||||||t-test, 1 sided|||We then examined the within-subjects factor of Time (Post-Treatment (10 week measure) - Baseline), for each Group, using a 1-tailed t test.||||0.0005
72622817|NCT02489279|144775743|SUPERIORITY|||||||0.21|||||||t-test, 1 sided|||We then examined the within-subjects factor of Time (Post-Treatment (10 week measure) - Baseline), for each Group, using a 1-tailed t test.||||0.21
72622818|NCT02489279|144775744|SUPERIORITY|||||||1e-06|||||||GLM with repeated measures ANOVA|||We used a GLM with time (Baseline and 10 Weeks) as the within subjects factor, experimental group (Active and Control) as the between subjects factor, and a group by time interaction to test for differential treatment effects. We report only a main effect of Time.||||0.000001
72622819|NCT02489279|144775745|SUPERIORITY|||||||0.00018|||||||GLM with repeated measures ANOVA|||We used a GLM with time (Baseline and 10 Weeks) as the within subjects factor, experimental group (Active and Control) as the between subjects factor, and a group by time interaction to test for differential treatment effects. We report only a main effect of Time.||||0.00018
72622820|NCT00831389|144775752|SUPERIORITY_OR_OTHER|||||||0.791||95.0||||p \< 0.05 is considered significant.|Wilcoxon (Mann-Whitney)|||Null hypothesis: Median change in PG concentration due to exercise for the OL and CL study phases do not differ.||||0.791
72395516|NCT02320149|144297465|SUPERIORITY||Least Squares Mean Difference|-13.3|||<|0.0001|TWO_SIDED|95.0|-17.5|-9.1||Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.|ANCOVA||sarecycline - placebo|Percent Change from Baseline to Week 6||-9.1|-17.5|< 0.0001
72395517|NCT02320149|144297466|SUPERIORITY||Least Squares Mean Difference|-7.2||||0.0003|TWO_SIDED|95.0|-11.1|-3.3||Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.|ANCOVA||sarecycline - placebo|Percent Change from Baseline to Week 3||-3.3|-11.1|0.0003
72395518|NCT02320149|144297467|SUPERIORITY||Least Squares Mean Difference|-3.9|||<|0.0001|TWO_SIDED|95.0|-5.3|-2.5||Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.|ANCOVA||sarecycline - placebo|Change from Baseline to Week 9||-2.5|-5.3|< 0.0001
72395519|NCT02320149|144297468|SUPERIORITY||Least Squares Mean Difference|-4.1|||<|0.0001|TWO_SIDED|95.0|-5.4|-2.9||Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.|ANCOVA||sarecycline - placebo|Change from Baseline to Week 6||-2.9|-5.4|< 0.0001
72395520|NCT02320149|144297469|SUPERIORITY||Least Squares Mean Difference|-2.1||||0.0005|TWO_SIDED|95.0|-3.3|-0.9||Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.|ANCOVA||sarecycline - placebo|Change from Baseline to Week 3||-0.9|-3.3|0.0005
72395521|NCT02320149|144297470|SUPERIORITY||Least Squares Mean Difference|-4.3||||0.5786|TWO_SIDED|95.0|-19.4|10.8||Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.|ANCOVA||sarecycline - placebo|Percent Change from Baseline to Week 12||10.8|-19.4|0.5786
72395522|NCT02320149|144297471|SUPERIORITY||Least Squares Mean Difference|-2.8||||0.6969|TWO_SIDED|95.0|-17.1|11.4||Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.|ANCOVA||sarecycline - placebo|Percent Change from Baseline to Week 9||11.4|-17.1|0.6969
72395523|NCT02320149|144297472|SUPERIORITY||Least Squares Mean Difference|3.0||||0.7377|TWO_SIDED|95.0|-14.7|20.7||Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.|ANCOVA||sarecycline - placebo|Percent Change from Baseline to Week 6||20.7|-14.7|0.7377
72395524|NCT02320149|144297473|SUPERIORITY||Least Squares Mean Difference|6.4||||0.2861|TWO_SIDED|95.0|-5.3|18.1||Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.|ANCOVA||sarecycline - placebo|Percent Change from Baseline to Week 3||18.1|-5.3|0.2861
72395525|NCT02320149|144297474|SUPERIORITY||Least Squares Mean Difference|-3.9||||0.0014|TWO_SIDED|95.0|-6.3|-1.5||Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.|ANCOVA||sarecycline - placebo|Change from Baseline to Week 12||-1.5|-6.3|0.0014
72471167|NCT04954326|144466108|EQUIVALENCE|The 90% Confidence Interval of the geometric mean ratios of the Lyophilisate compared to the Liquid formulations for Cday14 should be completely contained within the predefined \[80.00%-125.00%\] equivalence interval.|Geometric Mean Ratio (%)|121.5||||0.05|TWO_SIDED|90.0|98.7|149.6|||ANOVA|||Cday14 was natural log-transformed and analyzed using an analysis of variance (ANOVA) with fixed effect for formulation. The two one-sided tests procedures were performed on the geometric mean ratio (GMR) between test (S95014 lyophilizate) and reference (S95014 liquid formulation) treatments. The 90% confidence interval for the ratio was obtained within the framework of the ANOVA.||149.6|98.7|0.05
72471168|NCT00475228|144466111|SUPERIORITY_OR_OTHER|||||||0.05|||||||Chi-squared|||||||0.05
72471169|NCT03931746|144466114|SUPERIORITY||Hodges-Lehmann median difference|-3.5||||0.04|TWO_SIDED|95.0|-8.0|-0.5|||Wilcoxon (Mann-Whitney)|An exact Wilcoxon two-sample test was performed owing to the small sample size and number of tied observations.|Median difference is for Porcine Xenograft group minus No Porcine Xenograft group.|||-0.5|-8.0|0.04
72622821|NCT00831389|144775753|SUPERIORITY_OR_OTHER|||||||0.5||95.0||||p \< 0.05 is considered significant.|Wilcoxon (Mann-Whitney)|||Null hypothesis: Median tally of hypoglycemic events immediately following exercise for the OL and CL study phases do not differ.||||0.5
72395526|NCT02320149|144297475|SUPERIORITY||Least Squares Mean Difference|-3.4||||0.001|TWO_SIDED|95.0|-5.5|-1.4||Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.|ANCOVA||sarecycline - placebo|Change from Baseline to Week 9||-1.4|-5.5|0.0010
72395527|NCT02320149|144297476|SUPERIORITY||Least Squares Mean Difference|-2.0||||0.0371|TWO_SIDED|95.0|-4.0|-0.1||Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.|ANCOVA||sarecycline - placebo|Change from Baseline to Week 6||-0.1|-4.0|0.0371
72395528|NCT02320149|144297477|SUPERIORITY||Least Squares Mean Difference|-0.8||||0.3806|TWO_SIDED|95.0|-2.5|1.0||Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.|ANCOVA||sarecycline - placebo|Change from Baseline to Week 3||1.0|-2.5|0.3806
72395529|NCT01741701|144297484|SUPERIORITY_OR_OTHER|||||||0.5|TWO_SIDED||||||t-test, 2 sided|||||||0.50
72395530|NCT01741701|144297485|SUPERIORITY_OR_OTHER|||||||0.51|TWO_SIDED||||||t-test, 2 sided|||Comparison of change between groups from baseline to 4 months||||0.51
72395531|NCT01741701|144297486|SUPERIORITY_OR_OTHER|||||||0.97|TWO_SIDED||||||t-test, 2 sided|||Comparison between groups in the change from baseline to 4 months||||0.97
72622822|NCT00831389|144775754|SUPERIORITY_OR_OTHER|||||||0.25||95.0||||p \< 0.05 is considered significant.|Wilcoxon (Mann-Whitney)|||Null hypothesis: Median tally of nocturnal hypoglycemic events following exercise for the OL and CL study phases do not differ.||||0.25
72622823|NCT00831389|144775755|SUPERIORITY_OR_OTHER|||||||0.0669||95.0||||p \< 0.05 is considered significant.|Wilcoxon (Mann-Whitney)|||Null hypothesis: Median peak post-prandial PG for the OL and CL study phases do not differ.||||0.0669
72622824|NCT00831389|144775756|SUPERIORITY_OR_OTHER|||||||0.2256||95.0||||p \< 0.05 is considered significant.|Wilcoxon (Mann-Whitney)|||Null hypothesis: Median nadir PG immediately following exercise for the OL and CL study phases do not differ.||||0.2256
72622825|NCT00831389|144775757|SUPERIORITY_OR_OTHER|||||||0.791||95.0||||p \< 0.05 is considered significant.|Wilcoxon (Mann-Whitney)|||Null hypothesis: Median overnight nadir PG for the OL and CL arms do not differ.||||0.791
72471170|NCT03931746|144466115|SUPERIORITY||Hodges-Lehmann median difference|-2.5||||0.75|TWO_SIDED|95.0|-9.0|12.0|||Wilcoxon (Mann-Whitney)|An exact Wilcoxon two-sample test was performed owing to the small sample size and number of tied observations.|Median difference is for Porcine Xenograft minus No Porcine Xenograft.|||12|-9|0.75
72471171|NCT03931746|144466116|SUPERIORITY||Hodges-Lehmann median difference|1.0||||1|TWO_SIDED|95.0|-19.0|20.0|||Wilcoxon (Mann-Whitney)|An exact Wilcoxon two-sample test was performed owing to the small sample size and number of tied observations.|Median difference is for Porcine Xenograft group minus No Porcine Xenograft group.|||20.0|-19.0|1
72471172|NCT03931746|144466117|SUPERIORITY||Hodges-Lehmann median difference|0.01||||1|TWO_SIDED|95.0|-0.26|0.33|||Wilcoxon (Mann-Whitney)|An exact Wilcoxon two-sample test was performed owing to the small sample size and number of tied observations.|Median difference is for Porcine Xenograft vs. No Porcine Xenograft.|||0.33|-0.26|1
72471173|NCT03931746|144466118|SUPERIORITY||Hodges-Lehmann median difference|0.0||||1|TWO_SIDED|95.0|-6.0|4.0|||Wilcoxon (Mann-Whitney)|An exact Wilcoxon two-sample test was performed owing to the small sample size and number of tied observations.|Median difference is for Porcine Xenograft group minus No Porcine Xenograft group.|||4|-6|1
72471174|NCT03931746|144466119|SUPERIORITY||Hodges-Lehmann median difference|0.5||||0.54|TWO_SIDED|95.0|-1.0|2.0|||Wilcoxon (Mann-Whitney)|An exact Wilcoxon two-sample test was performed owing to the small sample size and number of tied observations.|Median difference is for Porcine Xenograft group minus No Porcine Xenograft group.|||2|-1|0.54
72471175|NCT03931746|144466120|SUPERIORITY||Odds Ratio (OR)|0.69||||1|TWO_SIDED|95.0|0.03|13.3|||Fisher Exact||"The No Porcine Xenograft group is the reference group."|||13.3|0.03|1
72505521|NCT01507545|144542313|SUPERIORITY||Difference of arms|-2.4||||0.333|TWO_SIDED|95.0|-6.992|2.23|||Fisher Exact|||||2.230|-6.992|0.333
72505522|NCT01873742|144542318|OTHER|The BDI's Cronbach's alpha was .93 at start of therapy, and .95 at the end of therapy.|Mean Difference (Final Values)|1.01|||<|0.05|TWO_SIDED||||||Mixed Models Analysis|||||||<0.05
72622826|NCT00831389|144775758|SUPERIORITY_OR_OTHER|||||||0.2036||95.0||||p \< 0.05 is considered significant.|Wilcoxon (Mann-Whitney)|||Null hypothesis: Median percentage of time PG is within euglycemic range for the OL and CL phases do not differ.||||0.2036
72622827|NCT00831389|144775759|SUPERIORITY_OR_OTHER|||||||0.6221||95.0||||p \< 0.05 is considered significant.|Wilcoxon (Mann-Whitney)|||Null hypothesis: Median percentage of time PG is above euglycemic range for the OL and CL phases do not differ.||||0.6221
72622828|NCT00831389|144775760|SUPERIORITY_OR_OTHER|||||||0.021||95.0||||p \< 0.05 is considered significant.|Wilcoxon (Mann-Whitney)|||Null hypothesis: Median percentage of time PG is below euglycemic range for the OL and CL phases do not differ.||||0.021
72622829|NCT00831389|144775761|SUPERIORITY_OR_OTHER|||||||0.0176||95.0||||p \< 0.05 is considered significant.|Wilcoxon (Mann-Whitney)|||Null hypothesis: Median tally of hypoglycemic events over 48 hour in-patient period for the OL and CL phases do not differ.||||0.0176
72622830|NCT00124657|144775786|SUPERIORITY_OR_OTHER||Kaplan-Meier|0.75|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|0.48|1.0||||||1-year progression-free survival (n=8)||1.00|0.48|
72622831|NCT00124657|144775786|SUPERIORITY_OR_OTHER||Kaplan-Meier|0.33|STANDARD_ERROR_OF_MEAN|0.12|||TWO_SIDED|95.0|0.09|0.57||||||1-year progression-free survival (n=12)||0.57|0.09|
72622832|NCT00124657|144775786|SUPERIORITY_OR_OTHER||Kaplan-Meier|0.45|STANDARD_DEVIATION|0.106|||TWO_SIDED|95.0|0.198|0.602||||||1-year progression free survival (n=20)||0.602|0.198|
72622833|NCT00124657|144775786|SUPERIORITY_OR_OTHER||Kaplan-Meier|0.15|STANDARD_DEVIATION|0.069|||TWO_SIDED|95.0|0.015|0.285||||||2-year progression free survival (n=20)||0.285|0.015|
72471176|NCT03931746|144466121|SUPERIORITY||Risk Difference (RD)|-0.167||||0.43|TWO_SIDED|95.0|-0.564|0.185|||Fisher Exact||"The risk difference is calculated as the outcome risk in the Porcine Xenograft group minus the outcome risk in the No Porcine Xenograft group. The confidence interval for the risk difference was calculated using the Newcombe hybrid score method."|||0.185|-0.564|0.43
72471177|NCT03931746|144466122|SUPERIORITY||Odds Ratio (OR)|0.6||||1|TWO_SIDED|95.0|0.006|55.9|||Fisher Exact||"The No Porcine Xenograft group is the reference group."|||55.9|0.006|1
72505523|NCT01753518|144542349|SUPERIORITY_OR_OTHER|||||||0.053|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.053
72505524|NCT01753518|144542350|SUPERIORITY_OR_OTHER|||||||0.73|TWO_SIDED||||||Chi-squared|||||||0.73
72505525|NCT01753518|144542351|SUPERIORITY_OR_OTHER|||||||0.25|TWO_SIDED||||||Fisher Exact|||Comparison for staple expulsion or suture trimming||||0.25
72622834|NCT00124657|144775786|SUPERIORITY_OR_OTHER||Kaplan-Meier|0.19|STANDARD_DEVIATION|0.077|||TWO_SIDED|95.0|0.039|0.341||||||1-year progression free survival (n=21)||0.341|0.039|
72622835|NCT00124657|144775786|SUPERIORITY_OR_OTHER||Kaplan-Meier|0.19|STANDARD_DEVIATION|0.077|||TWO_SIDED|95.0|0.039|0.341||||||2-year progression free survival (n=21)||0.341|0.039|
72622836|NCT04507763|144775798|OTHER|||||||0.001|||||||Regression, Logistic|||Change from Baseline at Month 12: For Early Referral||||0.001
72622837|NCT04507763|144775799|OTHER|||||||0.001|||||||Regression, Logistic|||Change from Baseline at Month 12: For Early Referral||||0.001
72622838|NCT02853136|144775816|OTHER||Adjusted geometric Mean ratio [%]|3107.8|||||TWO_SIDED|90.0|2332.9|4140.1|||||The estimated parameter was the adjusted geometric Mean (gMean) ratio \[%\] = adjusted gMean T2/ adjusted gMean R2. Intra-individual geometric coefficient of variation \[%\] =42.7.|The statistical model used for the analysis of the endpoint was an ANOVA (Analysis of Variance) model. This model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||4140.10|2332.90|
72505526|NCT01753518|144542351|SUPERIORITY_OR_OTHER|||||||0.06|TWO_SIDED||||||Fisher Exact|||Comparison for Surgical Site Infection||||0.06
72505527|NCT01753518|144542351|SUPERIORITY_OR_OTHER|||||||0.21|TWO_SIDED||||||Fisher Exact|||Comparison for Superficial Wound Separation||||0.21
72505528|NCT01753518|144542351|SUPERIORITY_OR_OTHER|||||||0.49|TWO_SIDED||||||Fisher Exact|||Comparison for Seroma||||0.49
72505529|NCT01753518|144542351|SUPERIORITY_OR_OTHER|||||||0.5|TWO_SIDED||||||Fisher Exact|||Comparison for Hematoma||||0.50
72505530|NCT01753518|144542352|SUPERIORITY_OR_OTHER|||||||0.48|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Comparison between the arms for Tylenol use.||||0.48
72505531|NCT01753518|144542352|SUPERIORITY_OR_OTHER|||||||0.3|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Comparison between the arms for Ibuprofen use.||||0.30
72505532|NCT01753518|144542352|SUPERIORITY_OR_OTHER|||||||0.85|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Comparison between the arms for Toradol use.||||0.85
72505533|NCT01753518|144542352|SUPERIORITY_OR_OTHER|||||||0.78|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Comparison between the arms for Oxycodone use.||||0.78
72505534|NCT01753518|144542354|SUPERIORITY_OR_OTHER|||||||0.51|TWO_SIDED||||||Fisher Exact|||"Comparison for negative responses to Appearance of incision question."||||0.51
72395532|NCT01741701|144297487|SUPERIORITY_OR_OTHER|||||||0.77|TWO_SIDED||||||t-test, 2 sided|||Comparison between groups in the change from baseline to 4 months||||.77
72395533|NCT01741701|144297488|SUPERIORITY_OR_OTHER|||||||0.9|TWO_SIDED||||||t-test, 2 sided|||Comparison between groups in change from baseline to 4 months||||.90
72565608|NCT02709486|144662686|SUPERIORITY||Least Square Mean Difference|-0.81|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-1.09|-0.53|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariates, and study site as a random effect.||-0.53|-1.09|<.0001
72565609|NCT02709486|144662686|SUPERIORITY||Least Square Mean Difference|-0.79|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-1.08|-0.51|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariates, and study site as a random effect.||-0.51|-1.08|<.0001
72565610|NCT02709486|144662686|SUPERIORITY||Least Square Mean Difference|-0.63|STANDARD_ERROR_OF_MEAN|0.15|<|0.0001|TWO_SIDED|95.0|-0.93|-0.33|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariates, and study site as a random effect.||-0.33|-0.93|<.0001
72395534|NCT01741701|144297489|SUPERIORITY_OR_OTHER|||||||0.95|TWO_SIDED||||||t-test, 2 sided|||Comparison between groups in change from baseline to 4 months||||.95
72395535|NCT00137046|144297504|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.024|STANDARD_ERROR_OF_MEAN|0.01||||90.0|-0.041|-0.007|||ANCOVA|||Month 3; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||-0.007|-0.041|
72505535|NCT01753518|144542354|SUPERIORITY_OR_OTHER|||||||0.098|TWO_SIDED||||||Chi-squared|||"Comparison for negative responses to Would recommend treatment to friends question."||||0.098
72505536|NCT01753518|144542354|SUPERIORITY_OR_OTHER|||||||0.57|TWO_SIDED||||||Chi-squared|||"Comparison of negative responses to Willingness to use treatment again question."||||0.57
72505537|NCT01753518|144542354|SUPERIORITY_OR_OTHER|||||||0.41|TWO_SIDED||||||Fisher Exact|||"Comparison of negative responses to Overall satisfaction question."||||0.41
72505538|NCT01753518|144542355|SUPERIORITY_OR_OTHER|||||||0.85|TWO_SIDED||||||Chi-squared|||"Comparison between arms for appearance of incision."||||0.85
72505539|NCT01753518|144542355|SUPERIORITY_OR_OTHER|||||||0.004|TWO_SIDED||||||Chi-squared|||"Comparison between arms for recommend treatment."||||0.004
72505540|NCT01753518|144542355|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Chi-squared|||"Comparison between arms for willingness to use treatment again."||||<0.001
72505541|NCT01753518|144542356|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<0.001
72505542|NCT01753518|144542357|SUPERIORITY_OR_OTHER|||||||0.35|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Comparison between arms for patient: scar painful.||||0.35
72505543|NCT01753518|144542357|SUPERIORITY_OR_OTHER|||||||0.48|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Comparison between arms for patient: scar itching.||||0.48
72505544|NCT01753518|144542357|SUPERIORITY_OR_OTHER|||||||0.034|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Comparison between arms for patient: scar color is different.||||0.034
72505545|NCT01753518|144542357|SUPERIORITY_OR_OTHER|||||||0.041|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Comparison between arms for patient: scar stiffness is different.||||0.041
72505546|NCT01753518|144542357|SUPERIORITY_OR_OTHER|||||||0.23|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Comparison between arms for patient: scar thickness is different.||||0.23
72505547|NCT01753518|144542357|SUPERIORITY_OR_OTHER|||||||0.13|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Comparison between arms for patient: scar more irregular.||||0.13
72505548|NCT01753518|144542357|SUPERIORITY_OR_OTHER|||||||0.11|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Comparison between arms for patient: overall opinion.||||0.11
72505549|NCT01753518|144542357|SUPERIORITY_OR_OTHER|||||||0.68|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Comparison between arms for observer: vascularity.||||0.68
72505550|NCT01753518|144542357|SUPERIORITY_OR_OTHER|||||||0.18|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Comparison between arms for observer: pigmentation.||||0.18
72505551|NCT01753518|144542357|SUPERIORITY_OR_OTHER|||||||0.75|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Comparison between arms for observer: thickness||||0.75
72505552|NCT01753518|144542357|SUPERIORITY_OR_OTHER|||||||0.36|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Comparison between arms for observer: relief.||||0.36
72505553|NCT01753518|144542357|SUPERIORITY_OR_OTHER|||||||0.78|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Comparison between arms for observer: pliability.||||0.78
72505554|NCT01753518|144542357|SUPERIORITY_OR_OTHER|||||||0.76|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Comparison between arms for observer: surface area.||||0.76
72622839|NCT02853136|144775817|OTHER||Adjusted geometric Mean ratio [%]|659.0|||||TWO_SIDED|90.0|489.791|886.676|||||The estimated parameter was the adjusted geometric Mean (gMean) ratio \[%\] = adjusted gMean T2/ adjusted gMean R2. Intra-individual geometric coefficient of variation \[%\]=44.8.|The statistical model used for the analysis of the endpoint was an ANOVA (Analysis of Variance) model. This model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||886.676|489.791|
72622840|NCT02853136|144775818|OTHER||Adjusted geometric Mean ratio [%]|3103.41|||||TWO_SIDED|90.0|2330.5|4132.65|||||"The estimated parameter was the adjusted geometric Mean (gMean) ratio \[%\] = adjusted gMean T2/ adjusted gMean R2.~Intra-individual geometric coefficient of variation \[%\] =42.7."|The statistical model used for the analysis of the endpoint was an ANOVA (Analysis of Variance) model. This model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||4132.65|2330.50|
72622841|NCT00841815|144775819|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of Least Squares Means|96.43||||||90.0|91.4|101.74|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||101.74|91.40|
72622842|NCT00841815|144775820|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of Least Squares Means|100.94||||||90.0|95.6|106.58|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||106.58|95.60|
72622843|NCT00841815|144775821|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of Least Squares Means|100.11||||||90.0|95.08|105.4|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||105.40|95.08|
72622844|NCT04620668|144775844|SUPERIORITY||||||<|0.001|||||||Mixed ANOVA|Assessing interaction between experimental group and time point.||||||<0.001
72622845|NCT04620668|144775844|SUPERIORITY||||||<|0.001|||||||Repeated Measures ANOVA|Assessing change within treatment group (follow-up to Mixed ANOVA).||||||<0.001
72622846|NCT04620668|144775844|SUPERIORITY|||||||0.044|||||||Dependent t-test (2-sided)|"Assessing change within treatment group from baseline to week 2 (follow-up to Repeated Measures ANOVA).~Bonferroni-adjusted p value."||||||0.044
72622847|NCT04620668|144775844|SUPERIORITY|||||||0.001|||||||Dependent t-test (2-sided)|"Assessing change within treatment group from week 2 to week 4 (follow-up to Repeated Measures ANOVA).~Bonferroni-adjusted p value."||||||0.001
72622848|NCT04620668|144775844|SUPERIORITY|||||||0.731|||||||Repeated Measures ANOVA|Assessing change within control group (follow-up to Mixed ANOVA).||||||0.731
72622849|NCT04620668|144775845|SUPERIORITY||||||<|0.001|||||||Mixed ANOVA|Assessing interaction between experimental group and time point.||||||<0.001
72622850|NCT04620668|144775845|SUPERIORITY||||||<|0.001|||||||Repeated Measures ANOVA|Assessing change within treatment group (follow-up to Mixed ANOVA).||||||<0.001
72622851|NCT04620668|144775845|SUPERIORITY|||||||0.05|||||||Dependent t-test (2-sided)|"Assessing change within treatment group from baseline to week 2 (follow-up to Repeated Measures ANOVA).~Bonferroni-adjusted p value."||||||0.05
72622852|NCT04620668|144775845|SUPERIORITY|||||||0.024|||||||Dependent t-test (2-sided)|"Assessing change within treatment group from week 2 to week 4 (follow-up to Repeated Measures ANOVA).~Bonferroni-adjusted p value."||||||0.024
72622853|NCT04620668|144775845|SUPERIORITY|||||||0.674|||||||Repeated Measures ANOVA|Assessing change within control group (follow-up to Mixed ANOVA).||||||0.674
72622854|NCT04620668|144775846|SUPERIORITY|||||||0.159|||||||Mixed ANOVA|Assessing interaction between experimental group and time point.||||||0.159
72622855|NCT04620668|144775847|SUPERIORITY|||||||0.326|||||||Mixed ANOVA|Assessing interaction between experimental group and time point.||||||0.326
72622856|NCT03647137|144775855|OTHER||Standardized β Coefficient|-2.256||||0.00468|TWO_SIDED|||||The p-value is derived from model comparison between the FEOVB model and the FEOVB\*PIB interaction model.|ChiSq Goodness of Fit Test|||L-DOPA sensitivity outcome measure was modeled with 3-level hierarchical ordinal logistic regression. The null model contained only striatal DTBZ as predictor of group, the FEOVB model additionally had FEOVB tracer, and interaction model had in addition an interaction term between FEOVB and PIB tracer. Model comparisons were performed using Chi-Square goodness of fit test.||||0.00468
72622857|NCT02655601|144775868|SUPERIORITY||Hazard Ratio (HR)|0.791||||0.135|ONE_SIDED|95.0||95.0||Study was originally designed with 1 IA after approximately 42 deaths. An unplanned, 2nd IA was conducted to support a BTDR. The study was not terminated early as a result of either IAs. No further IA were conducted until the primary analysis.|Log Rank|89 study participants had passed away at the time of this analysis (41 in the RT/TMZ + BMX-001 arm and 48 in the Radiation Therapy/TMZ arm).||A 1-tailed logrank test was conducted at the 0.2 level. This test had 90% power to detect a hazard ratio of 0.63 after 84 deaths were observed among the 160 randomized patients.||95||0.135
72622858|NCT02655601|144775880|SUPERIORITY||Odds Ratio (OR)|0.45||||0.465|ONE_SIDED||||||Fisher Exact|||With 78 and 71 patients in Arms A and B, respectively, there was 80% power with a one-tailed chi-square test (α=0.05) to detect a reduction in grade 3 or 4 thrombocytopenia from 15% in Arm B (without BMX-001) to 3.7% in Arm A (with BMX-001). Given the small number of patients that experienced low platelet counts or thrombocytopenia, a one-tailed Fisher's exact test was performed instead.||||0.465
72622859|NCT02655601|144775881|SUPERIORITY||Hazard Ratio (HR)|0.978||||0.911|ONE_SIDED||||||Log Rank|||A 1-tailed logrank test was conducted at the 0.2 level.||||0.911
72622860|NCT02655601|144775882|SUPERIORITY|||||||0.401|||||||Chi-squared, Corrected|A continuity adjusted Chi-Squared test was performed.||||||0.401
72622861|NCT01603368|144775907|OTHER|Student's t-test|||||=|0.001|||||||t-test, 2 sided|||||||=0.001
72471178|NCT02473965|144466129|SUPERIORITY||Odds Ratio (OR)|0.868|||=|1|TWO_SIDED|95.0|0.27|2.787||The statistical inference was tested as 2-sided with alpha=0.05.|Fisher Exact|||An unstratified analysis using Fisher's exact test was used for treatment comparison without adjustment for stratified baseline prednisone equivalent dose level due to the small cell size. The odds ratio and confidence intervals are calculated overall (i.e. all mITT subjects).||2.787|0.270|=1.00
72471179|NCT02473965|144466130|SUPERIORITY||LS mean difference|1.58|STANDARD_ERROR_OF_MEAN|12.536|=|0.9|TWO_SIDED|95.0|-23.52|26.68|||ANCOVA|||Treatment comparison of percent change in daily CS dose from baseline to Week 39. The Analysis of Covariance model included the percent change from baseline in daily CS dose as the dependent variable, treatment as a fixed effect and baseline daily CS dose as covariate.||26.68|-23.52|=0.900
72471180|NCT01183390|144466132|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|98.6|||||TWO_SIDED|90.0|95.1|102.28|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||102.28|95.10|
72471181|NCT01183390|144466133|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|99.4|||||TWO_SIDED|90.0|96.99|101.8|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||101.80|96.99|
72471182|NCT01730950|144466159|SUPERIORITY||Hazard Ratio (HR)|0.98||||0.46|TWO_SIDED|95.0|0.7|1.38|||Log Rank|Two-side significance level = 0.05|Reference level = Bevacizumab|Null hypothesis: median survival time for both arms is 9 months; alternative hypothesis: participants receiving radiation therapy plus bevacizumab will have an improvement in median survival time to 13 months. One hundred and sixty eligible participants provides 80% power to detect a 31% reduction in the hazard ratio to 0.69 at a one-sided significance level of 0.10. Analysis was planned to occur when 135 deaths were reported, expected to occur 16 to 21 months after trial closure.||1.38|0.70|0.46
72471183|NCT01730950|144466160|SUPERIORITY|||||||0.18|||||||Chi-squared|Two-sided significance level = 0.05||||||0.18
72471184|NCT01730950|144466161|SUPERIORITY|||||||0.001|||||||Chi-squared|Two-sided significance level = 0.05||||||0.001
72471185|NCT01730950|144466162|SUPERIORITY||Hazard Ratio (HR)|0.73||||0.05|TWO_SIDED|95.0|0.53|1.0|||Log Rank|Two-sided significance level = 0.05|Reference level = Bevacizumab|||1.00|0.53|0.05
72395536|NCT00137046|144297504|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.022|STANDARD_ERROR_OF_MEAN|0.011||||90.0|-0.04|-0.003|||ANCOVA|||Month 6; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||-0.003|-0.040|
72471186|NCT00667459|144466165|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The non-inferiority margin is 0.1.|Risk Difference (RD)|0.032||||0.995|TWO_SIDED|95.0|-0.07|0.134||The posterior probably of non-inferiority was calculated and presented instead of the p-value.|Bayesian logistic model|The propensity score method was used to adjust possible effects on outcomes caused by differences in baseline characteristic due to non-randomization.|The posterior mean of P1-P0, along with the corresponding 95% highest posterior density (HPD) interval was presented instead of the usual 95% CI.|"The null hypothesis H0: p1 + d ≤ p0, and the alternative hypothesis is Ha: p1 + d \> p0 where P0 and P1 are the overall success rates in the control group and the investigational group respectively, and d is the non-inferiority margin. The analyses used Bayesian methodology. Should the posterior probability P(p1 - p0 \> -d \| data) be at least 0.95, then the null noninferiority hypothesis will be rejected, and non-inferiority of the investigational device to the control will be claimed."||0.134|-0.070|0.995
72471187|NCT00667459|144466165|SUPERIORITY_OR_OTHER_LEGACY|||||||0.736||95.0||||The posterior probably of superiority was calculated and presented instead of the p-value.|Bayesian logistic model|The propensity score method was used to adjust possible effects on outcomes caused by differences in baseline characteristic due to non-randomization.||Superiority comparison of success rates in two treatment groups was a secondary objective of this trial. Superiority analysis was performed if non-inferiority was demonstrated. If the posterior probability is at least 0.95, a claim of superiority can be made.||||0.736
72471188|NCT00667459|144466166|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority margin is 0.1.|Risk Difference (RD)|0.048||||1|TWO_SIDED|95.0|-0.02|0.118||The posterior probably of non-inferiority was calculated and presented instead of the p-value.|Bayesian logistic model|The propensity score method was used to adjust possible effects on outcomes caused by differences in baseline characteristic due to non-randomization.|The posterior mean of P1-P0, along with the corresponding 95% highest posterior density (HPD) interval was presented instead of the usual 95% CI.|"The null hypothesis H0: p1 + d ≤ p0, and the alternative hypothesis is Ha: p1 + d \> p0 where P0 and P1 are the success rates of NDI in the control group and the investigational group respectively, and d is the non-inferiority margin. The analyses used Bayesian methodology. Should the posterior probability P(p1 - p0 \> -d \| data) be at least 0.95, then the null noninferiority hypothesis will be rejected, and non-inferiority of the investigational group will be claimed for this endpoint."||0.118|-0.020|1.0
72471189|NCT00667459|144466166|SUPERIORITY_OR_OTHER_LEGACY|||||||0.912||95.0||||The posterior probably of superiority was calculated and presented instead of the p-value.|Bayesian logistic model|The propensity score method was used to adjust possible effects on outcomes caused by differences in baseline characteristic due to non-randomization.||Superiority comparison of success rates in two treatment groups was a secondary objective of this trial. Superiority analysis was performed if non-inferiority was demonstrated.||||0.912
72622862|NCT01251757|144775927|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.022|||<|0.001|TWO_SIDED|95.0|0.011|0.034|||Regression, Linear|adjusted for site, gender, age, total number of prescription medications patient is taking, comorbid diabetes/CVD, and baseline statin adherence.|Adjusted difference in adherence for IVR group versus UC group, calculated as IVR - UC.|We conducted separate primary analyses of each of IVR and IVR+ versus usual care at the .025 level of significance to assure a trial-wide error rate of .05. This analysis summary is for the IVR versus UC comparison only. Also, we only report results here for the full sample, and not also separately for the 3 baseline adherence level groups.||0.034|0.011|<.001
72395537|NCT00137046|144297504|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.019|STANDARD_ERROR_OF_MEAN|0.012||||90.0|-0.038|0.001|||ANCOVA|||Month 9; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||0.001|-0.038|
72395538|NCT00137046|144297504|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.038|STANDARD_ERROR_OF_MEAN|0.012||||90.0|-0.058|-0.019|||ANCOVA|||Month 12; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||-0.019|-0.058|
72395539|NCT00137046|144297504|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.042|STANDARD_ERROR_OF_MEAN|0.014||||90.0|-0.065|-0.02|||ANCOVA|||Month 15; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||-0.020|-0.065|
72395540|NCT00137046|144297504|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.014||||90.0|-0.043|0.002|||ANCOVA|||Month 18; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||0.002|-0.043|
72395541|NCT00137046|144297504|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.043|STANDARD_ERROR_OF_MEAN|0.014||||90.0|-0.066|-0.02|||ANCOVA|||Month 21; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||-0.020|-0.066|
72395542|NCT00137046|144297504|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.033|STANDARD_ERROR_OF_MEAN|0.015||||90.0|-0.058|-0.009|||ANCOVA|||Month 24; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||-0.009|-0.058|
72395543|NCT00137046|144297504|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.015|STANDARD_ERROR_OF_MEAN|0.015||||90.0|-0.039|0.009|||ANCOVA|||Follow-up Month 1; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||0.009|-0.039|
72395544|NCT00137046|144297504|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.005|STANDARD_ERROR_OF_MEAN|0.014||||90.0|-0.027|0.017|||ANCOVA|||Follow-up Month 3; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||0.017|-0.027|
72395545|NCT00137046|144297504|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.013|STANDARD_ERROR_OF_MEAN|0.015||||90.0|-0.037|0.012|||ANCOVA|||Follow-up Month 6; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||0.012|-0.037|
72395546|NCT00137046|144297504|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.045|STANDARD_ERROR_OF_MEAN|0.019||||90.0|-0.076|-0.014|||ANCOVA|||Extension Month 1; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||-0.014|-0.076|
72395547|NCT00137046|144297504|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.045|STANDARD_ERROR_OF_MEAN|0.019||||90.0|-0.076|-0.013|||ANCOVA|||Extension Month 3; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||-0.013|-0.076|
72395548|NCT00137046|144297504|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.04|STANDARD_ERROR_OF_MEAN|0.019||||90.0|-0.071|-0.008|||ANCOVA|||Extension Month 6; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||-0.008|-0.071|
72395549|NCT00137046|144297504|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.041|STANDARD_ERROR_OF_MEAN|0.02||||90.0|-0.074|-0.008|||ANCOVA|||Extension Month 9; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||-0.008|-0.074|
72395550|NCT00137046|144297504|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.056|STANDARD_ERROR_OF_MEAN|0.019||||90.0|-0.088|-0.025|||ANCOVA|||Extension Month 12; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||-0.025|-0.088|
72395551|NCT00137046|144297504|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.039|STANDARD_ERROR_OF_MEAN|0.019||||90.0|-0.071|-0.007|||ANCOVA|||Extension Month 15; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||-0.007|-0.071|
72395552|NCT00137046|144297504|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.044|STANDARD_ERROR_OF_MEAN|0.021||||90.0|-0.079|-0.01|||ANCOVA|||Extension Month 18; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||-0.010|-0.079|
72395553|NCT00137046|144297504|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.022||||90.0|-0.055|0.016|||ANCOVA|||Extension Month 21; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||0.016|-0.055|
72395554|NCT00137046|144297504|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.042|STANDARD_ERROR_OF_MEAN|0.022||||90.0|-0.079|-0.004|||ANCOVA|||Extension Month 24; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||-0.004|-0.079|
72505555|NCT01753518|144542357|SUPERIORITY_OR_OTHER|||||||0.97|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Comparison between arms for observer: overall opinion.||||0.97
72505556|NCT02075255|144542370|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|33.3|||<|0.001|TWO_SIDED|95.0|16.7|50.0|||Wilcoxon (Mann-Whitney)||Hodges-Lehmann estimate is used.|||50.00|16.70|<0.001
72505557|NCT02075255|144542370|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|37.5|||<|0.001|TWO_SIDED|95.0|20.8|50.0|||Wilcoxon (Mann-Whitney)||Hodges Lehmann estimate is used.|||50.00|20.80|<0.001
72505558|NCT02075255|144542371|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.09|||<|0.001|TWO_SIDED|95.0|2.22|7.57|||proportional odds model|Controlling for treatment group, region, and baseline OCS dose.||||7.57|2.22|<0.001
72505559|NCT02075255|144542371|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.12|||<|0.001|TWO_SIDED|95.0|2.22|7.63|||proportional odds model|Controlling for treatment group, region, and baseline OCS dose.||||7.63|2.22|<0.001
72505560|NCT02075255|144542372|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|50.0|||<|0.001|TWO_SIDED|95.0|25.0|66.7|||Wilcoxon (Mann-Whitney)||Hodges Lehmann estimate is used.|||66.70|25.00|<0.001
72565611|NCT02709486|144662686|SUPERIORITY||Least Square Mean Difference|-0.76|STANDARD_ERROR_OF_MEAN|0.15|<|0.0001|TWO_SIDED|95.0|-1.06|-0.47|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariates, and study site as a random effect.||-0.47|-1.06|<.0001
72505561|NCT02075255|144542372|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|50.0|||<|0.001|TWO_SIDED|95.0|25.0|66.7|||Wilcoxon (Mann-Whitney)||Hodges Lehmann estimate is used.|||66.70|25.00|<0.001
72505562|NCT02075255|144542373|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.59|||<|0.001|TWO_SIDED|95.0|1.79|7.22|||Cochran-Mantel-Haenszel|Controlling for region.||||7.22|1.79|<0.001
72505563|NCT02075255|144542373|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.03|||<|0.001|TWO_SIDED|95.0|1.57|5.86|||Cochran-Mantel-Haenszel|Controlling for region.||||5.86|1.57|<0.001
72505564|NCT02075255|144542374|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.23|||<|0.001|TWO_SIDED|95.0|1.92|14.21|||Cochran-Mantel-Haenszel|Controlling for region.||||14.21|1.92|<0.001
72505565|NCT02075255|144542374|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.19||||0.002|TWO_SIDED|95.0|1.58|11.12|||Cochran-Mantel-Haenszel|Controlling for region.||||11.12|1.58|0.002
72505566|NCT02075255|144542375|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.42||||0.012|TWO_SIDED|95.0|0.21|0.83|||Cochran-Mantel-Haenszel|Controlling for region.||||0.83|0.21|0.012
72505567|NCT02075255|144542375|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.52||||0.053|TWO_SIDED|95.0|0.27|1.01|||Cochran-Mantel-Haenszel|Controlling for region.||||1.01|0.27|0.053
72505568|NCT02075255|144542376|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.16|||<|0.001|TWO_SIDED|95.0|1.6|6.23|||Cochran-Mantel-Haenszel|Controlling for region.||||6.23|1.60|<0.001
72505569|NCT02075255|144542376|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.74||||0.002|TWO_SIDED|95.0|1.41|5.31|||Cochran-Mantel-Haenszel|Controlling for region.||||5.31|1.41|0.002
72505570|NCT02075255|144542377|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.32||||0.001|TWO_SIDED|95.0|0.16|0.65|||Cochran-Mantel-Haenszel|Controlling for region.||||0.65|0.16|0.001
72505571|NCT02075255|144542377|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.28|||<|0.001|TWO_SIDED|95.0|0.14|0.56|||Cochran-Mantel-Haenszel|Controlling for region.||||0.56|0.14|<0.001
72505572|NCT02075255|144542378|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.39|||<|0.001|TWO_SIDED|95.0|0.22|0.66|||Regression, Cox|Including covariates treatment group, region, number of exacerbations in the previous year.||||0.66|0.22|<0.001
72505573|NCT02075255|144542378|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.32|||<|0.001|TWO_SIDED|95.0|0.17|0.57|||Regression, Cox|Including covariates treatment group, region, number of exacerbations in the previous year.||||0.57|0.17|<0.001
72505574|NCT02075255|144542379|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.53||||0.291|TWO_SIDED|95.0|0.14|1.64|||Regression, Cox|Including covariates treatment group, region, any exacerbations in the previous year requiring hospitalization or ER visit.||||1.64|0.14|0.291
72505575|NCT02075255|144542379|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.12||||0.042|TWO_SIDED|95.0|0.01|0.63|||Regression, Cox|Including covariates treatment group, region, any exacerbations in the previous year requiring hospitalization or ER visit.||||0.63|0.01|0.042
72505576|NCT02075255|144542380|SUPERIORITY_OR_OTHER||Rate ratio|0.45||||0.003|TWO_SIDED|95.0|0.27|0.76|||negative binomial model|Including covariates treatment group, region, number of exacerbations in the previous year. The log of follow-up time is used as offset variable.||||0.76|0.27|0.003
72505577|NCT02075255|144542380|SUPERIORITY_OR_OTHER||Rate ratio|0.3|||<|0.001|TWO_SIDED|95.0|0.17|0.53|||negative binomial model|Including covariates treatment group, region, number of exacerbations in the previous year. The log of follow-up time is used as offset variable.||||0.53|0.17|<0.001
72505578|NCT02075255|144542381|SUPERIORITY_OR_OTHER||Rate ratio|0.44||||0.187|TWO_SIDED|95.0|0.13|1.49|||negative binomial model|Covariates include treatment, region, any exacerbations in the previous year requiring hospitalization/ER. Log of follow-up time is the offset.||||1.49|0.13|0.187
72505579|NCT02075255|144542381|SUPERIORITY_OR_OTHER||Rate ratio|0.07||||0.018|TWO_SIDED|95.0|0.01|0.63|||negative binomial model|Covariates include treatment, region, any exacerbations in the previous year requiring hospitalization/ER. Log of follow-up time is the offset.||||0.63|0.01|0.018
72505580|NCT02075255|144542383|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.105||||0.153|TWO_SIDED|95.0|-0.04|0.251|||Mixed Models Analysis|Including covariates: treatment group, region, baseline pre-BD FEV1 value, visit, and visit by treatment interaction.||||0.251|-0.040|0.153
72505581|NCT02075255|144542383|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.112||||0.129|TWO_SIDED|95.0|-0.033|0.258|||Mixed Models Analysis|Including covariates: treatment group, region, baseline pre-BD FEV1 value, visit, and visit by treatment interaction.||||0.258|-0.033|0.129
72505582|NCT02075255|144542384|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01||||0.947|TWO_SIDED|95.0|-0.35|0.32|||Mixed Models Analysis|Include covariates: treatment group, baseline asthma symptom score, region, visit, and treatment by visit interaction.||||0.32|-0.35|0.947
72576676|NCT00094861|144680141|SUPERIORITY_OR_OTHER||Chi-Square Statistic|3.1414||||0.1996||||||Generalized Cochran-Mantel-Haenszel test for mean score difference using modified ridit score.|Cochran-Mantel-Haenszel|Stratified by disease stage, ECOG performance status, and estimated weight loss in the 3 months before study randomization.||||||0.1996
72395555|NCT00137046|144297504|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.055|STANDARD_ERROR_OF_MEAN|0.022||||90.0|-0.091|-0.019|||ANCOVA|||Extension Month 27; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||-0.019|-0.091|
72395556|NCT00137046|144297504|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.045|STANDARD_ERROR_OF_MEAN|0.022||||90.0|-0.081|-0.01|||ANCOVA|||Extension Month 30; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||-0.010|-0.081|
72395557|NCT00137046|144297504|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.036|STANDARD_ERROR_OF_MEAN|0.023||||90.0|-0.073|0.002|||ANCOVA|||Extension Month 33; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||0.002|-0.073|
72395558|NCT00137046|144297504|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.079|STANDARD_ERROR_OF_MEAN|0.025||||90.0|-0.121|-0.038|||ANCOVA|||Extension Month 36; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||-0.038|-0.121|
72395559|NCT00137046|144297504|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.061|STANDARD_ERROR_OF_MEAN|0.038||||90.0|-0.124|0.003|||ANCOVA|||Extension Month 39; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||0.003|-0.124|
72395560|NCT00137046|144297504|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.066|STANDARD_ERROR_OF_MEAN|0.02||||90.0|-0.098|-0.033|||ANCOVA|||Extension Month 39 (LOCF); Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||-0.033|-0.098|
72395561|NCT00137046|144297504|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.044|STANDARD_ERROR_OF_MEAN|0.024||||90.0|-0.085|-0.004|||ANCOVA|||Extension Follow Up Month 3; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||-0.004|-0.085|
72395562|NCT00137046|144297506|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.031|STANDARD_ERROR_OF_MEAN|0.055||||90.0|-0.06|0.122|||ANCOVA|||Month 3; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline HbA1c, and Center.||0.122|-0.060|
72395563|NCT00137046|144297506|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.136|STANDARD_ERROR_OF_MEAN|0.062||||90.0|0.033|0.239|||ANCOVA|||Month 6; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline HbA1c, and Center.||0.239|0.033|
72395564|NCT00137046|144297506|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.112|STANDARD_ERROR_OF_MEAN|0.068||||90.0|0.0|0.224|||ANCOVA|||Month 9; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline HbA1c, and Center.||0.224|-0.000|
72395565|NCT00137046|144297506|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.257|STANDARD_ERROR_OF_MEAN|0.071||||90.0|0.141|0.374|||ANCOVA|||Month 12; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline HbA1c, and Center.||0.374|0.141|
72395566|NCT00137046|144297506|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.156|STANDARD_ERROR_OF_MEAN|0.071||||90.0|0.04|0.273|||ANCOVA|||Month 15; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline HbA1c, and Center.||0.273|0.040|
72395567|NCT00137046|144297506|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.182|STANDARD_ERROR_OF_MEAN|0.072||||90.0|0.065|0.3|||ANCOVA|||Month 18; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline HbA1c, and Center.||0.300|0.065|
72395568|NCT00137046|144297506|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.19|STANDARD_ERROR_OF_MEAN|0.078||||90.0|0.06|0.319|||ANCOVA|||Month 21; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline HbA1c, and Center.||0.319|0.060|
72395569|NCT00137046|144297506|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.316|STANDARD_ERROR_OF_MEAN|0.077||||90.0|0.19|0.443|||ANCOVA|||Month 24; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline HbA1c, and Center.||0.443|0.190|
72395570|NCT00137046|144297506|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.093|STANDARD_ERROR_OF_MEAN|0.079||||90.0|-0.037|0.224|||ANCOVA|||Follow-up Month 3; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline HbA1c, and Center.||0.224|-0.037|
72395571|NCT00137046|144297506|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.021|STANDARD_ERROR_OF_MEAN|0.075||||90.0|-0.103|0.145|||ANCOVA|||Follow-up Month 6; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline HbA1c, and Center.||0.145|-0.103|
72395572|NCT00137046|144297506|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.112|STANDARD_ERROR_OF_MEAN|0.082||||90.0|-0.023|0.248|||ANCOVA|||Extension Month 1; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline HbA1c, and Center.||0.248|-0.023|
72395573|NCT00137046|144297506|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.273|STANDARD_ERROR_OF_MEAN|0.089||||90.0|0.126|0.419|||ANCOVA|||Extension Month 3; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline HbA1c, and Center.||0.419|0.126|
72395574|NCT00137046|144297506|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.363|STANDARD_ERROR_OF_MEAN|0.087||||90.0|0.219|0.507|||ANCOVA|||Extension Month 6; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline HbA1c, and Center.||0.507|0.219|
72395575|NCT00137046|144297506|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.278|STANDARD_ERROR_OF_MEAN|0.091||||90.0|0.128|0.428|||ANCOVA|||Extension Month 9; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline HbA1c, and Center.||0.428|0.128|
72395576|NCT00137046|144297506|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.293|STANDARD_ERROR_OF_MEAN|0.091||||90.0|0.144|0.442|||ANCOVA|||Extension Month 12; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline HbA1c, and Center.||0.442|0.144|
72395577|NCT00137046|144297506|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.213|STANDARD_ERROR_OF_MEAN|0.094||||90.0|0.058|0.369|||ANCOVA|||Extension Month 15; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline HbA1c, and Center.||0.369|0.058|
72505583|NCT02075255|144542384|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.18||||0.291|TWO_SIDED|95.0|-0.51|0.16|||Mixed Models Analysis|Include covariates: treatment group, baseline asthma symptom score, region, visit, and treatment by visit interaction.||||0.16|-0.51|0.291
72505584|NCT02075255|144542385|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.998|TWO_SIDED|95.0|-0.18|0.18|||Mixed Models Analysis|Include covariates: treatment group, baseline asthma symptom score, region, visit, and treatment by visit interaction.||||0.18|-0.18|0.998
72505585|NCT02075255|144542385|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.12||||0.177|TWO_SIDED|95.0|-0.3|0.05|||Mixed Models Analysis|Include covariates: treatment group, baseline asthma symptom score, region, visit, and treatment by visit interaction.||||0.05|-0.30|0.177
72505586|NCT02075255|144542386|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.973|TWO_SIDED|95.0|-0.17|0.17|||Mixed Models Analysis|Include covariates: treatment group, baseline asthma symptom score, region, visit, and treatment by visit interaction.||||0.17|-0.17|0.973
72505587|NCT02075255|144542386|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.06||||0.48|TWO_SIDED|95.0|-0.23|0.11|||Mixed Models Analysis|Include covariates: treatment group, baseline asthma symptom score, region, visit, and treatment by visit interaction.||||0.11|-0.23|0.480
72505588|NCT02075255|144542387|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.43||||0.397|TWO_SIDED|95.0|-1.44|0.57|||Mixed Models Analysis|Include covariates: treatment group, baseline total asthma rescue medication use, region, visit, and treatment by visit interaction.||||0.57|-1.44|0.397
72505589|NCT02075255|144542387|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.41||||0.006|TWO_SIDED|95.0|-2.42|-0.41|||Mixed Models Analysis|Include covariates: treatment group, baseline total asthma rescue medication use, region, visit, and treatment by visit interaction.||||-0.41|-2.42|0.006
72505590|NCT02075255|144542388|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|19.25||||0.143|TWO_SIDED|95.0|-6.58|45.07|||Mixed Models Analysis|Include covariates: treatment group, baseline morning PEF, region, visit, and treatment by visit interaction.||||45.07|-6.58|0.143
72505591|NCT02075255|144542388|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|30.01||||0.023|TWO_SIDED|95.0|4.26|55.76|||Mixed Models Analysis|Include covariates: treatment group, baseline morning PEF, region, visit, and treatment by visit interaction.||||55.76|4.26|0.023
72505592|NCT02075255|144542389|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|15.19||||0.237|TWO_SIDED|95.0|-10.08|40.46|||Mixed Models Analysis|Include covariates: treatment group, baseline evening PEF, region, visit, and treatment by visit interaction.||||40.46|-10.08|0.237
72505593|NCT02075255|144542389|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|31.52||||0.014|TWO_SIDED|95.0|6.32|56.71|||Mixed Models Analysis|Include covariates: treatment group, baseline evening PEF, region, visit, and treatment by visit interaction.||||56.71|6.32|0.014
72565612|NCT02709486|144662686|SUPERIORITY||Least Square Mean Difference|-0.79|STANDARD_ERROR_OF_MEAN|0.16|<|0.0001|TWO_SIDED|95.0|-1.11|-0.46|||ANCOVA|||Week 12: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariates, and study site as a random effect.||-0.46|-1.11|<.0001
72395578|NCT00137046|144297506|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.243|STANDARD_ERROR_OF_MEAN|0.086||||90.0|0.101|0.386|||ANCOVA|||Extension Month 18; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline HbA1c, and Center.||0.386|0.101|
72505594|NCT02075255|144542390|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.02||||0.742|TWO_SIDED|95.0|-0.08|0.11|||Mixed Models Analysis|Including covariates: treatment group, baseline proportion of nights with noctural awakenings, region, visit, and treatment by visit interaction.||||0.11|-0.08|0.742
72505595|NCT02075255|144542390|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02||||0.693|TWO_SIDED|95.0|-0.11|0.07|||Mixed Models Analysis|Including covariates: treatment group, baseline proportion of nights with noctural awakenings, region, visit, and treatment by visit interaction.||||0.07|-0.11|0.693
72505596|NCT02075255|144542391|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.24||||0.139|TWO_SIDED|95.0|-0.55|0.08|||Mixed Models Analysis|Include covariates: treatment group, baseline ACQ-6 score, region, visit, and treatment by visit interaction.||||0.08|-0.55|0.139
72505597|NCT02075255|144542391|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.55||||0.001|TWO_SIDED|95.0|-0.86|-0.23|||Mixed Models Analysis|Include covariates: treatment group, baseline ACQ-6 score, region, visit, and treatment by visit interaction.||||-0.23|-0.86|0.001
72505598|NCT02075255|144542392|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.165||||0.658|TWO_SIDED|95.0|0.592|2.295|||Regression, Logistic|Including covariates: treatment group, baseline ACQ-6 score, region, number of exacerbations in the previous year.||||2.295|0.592|0.658
72505599|NCT02075255|144542392|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.661||||0.155|TWO_SIDED|95.0|0.826|3.34|||Regression, Logistic|Including covariates: treatment group, baseline ACQ-6 score, region, number of exacerbations in the previous year.||||3.340|0.826|0.155
72505600|NCT02075255|144542393|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.23||||0.151|TWO_SIDED|95.0|-0.08|0.53|||Mixed Models Analysis|Including covariates: treatment group, region, baseline AQLQ(S)+12 score, visit, and treatment by visit interaction.||||0.53|-0.08|0.151
72505601|NCT02075255|144542393|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.45||||0.004|TWO_SIDED|95.0|0.14|0.76|||Mixed Models Analysis|Including covariates: treatment group, region, baseline AQLQ(S)+12 score, visit, and treatment by visit interaction.||||0.76|0.14|0.004
72505602|NCT02075255|144542394|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.538||||0.22|TWO_SIDED|95.0|0.773|3.06|||Regression, Logistic|Including covariates: treatment group, region, baseline AQLQ(S)+12 score, number of exacerbations in the previous year.||||3.060|0.773|0.220
72505603|NCT02075255|144542394|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.783||||0.108|TWO_SIDED|95.0|0.882|3.605|||Regression, Logistic|Including covariates: treatment group, region, baseline AQLQ(S)+12 score, number of exacerbations in the previous year.||||3.605|0.882|0.108
72565613|NCT02709486|144662686|SUPERIORITY||Least Square Mean Difference|-0.82|STANDARD_ERROR_OF_MEAN|0.16|<|0.0001|TWO_SIDED|95.0|-1.15|-0.5|||ANCOVA|||Week 12: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariates, and study site as a random effect.||-0.50|-1.15|<.0001
72505604|NCT02075255|144542398|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-162.2|||<|0.001|TWO_SIDED|95.0|-220.1|-104.3|||Mixed Models Analysis|Include covariates: treatment group, baseline eosinophil count, region, visit, treatment by visit|Percent change|||-104.3|-220.1|<0.001
72505605|NCT02075255|144542398|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-159.4|||<|0.001|TWO_SIDED|95.0|-217.9|-100.9|||Mixed Models Analysis|Include covariates: treatment group, baseline eosinophil count, region, visit, treatment by visit.|Percent change|||-100.9|-217.9|<0.001
72395579|NCT00137046|144297506|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.227|STANDARD_ERROR_OF_MEAN|0.09||||90.0|0.079|0.376|||ANCOVA|||Extension Month 21; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline HbA1c, and Center.||0.376|0.079|
72505606|NCT01426386|144542405|OTHER|Based on the ANCOVA model the slope of the dose-response curve was estimated. Null hypothesis: Slope of dose-response curve equal to 0 (zero)|Slope of the dose-response curve|7.9|||<|0.001|TWO_SIDED|95.0|5.69|10.18||The a priori threshold for statistical significance was 5% (two-sided)|ANCOVA|Number of oocytes retrieved as dependent variable, centre and AMH strata (5.0-14.9 pmol/L and 15.0-44.9 pmol/L) as factors and log(dose) as covariate||The dose-response relationship was analysed using an analysis of covariance (ANCOVA) model||10.18|5.69|<0.001
72542423|NCT00272961|144614638|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.93|STANDARD_ERROR_OF_MEAN|5.12||0.5719|TWO_SIDED|95.0|-13.46|7.6|||ANCOVA|||Week 10 Standing: p-value was obtained using an ANCOVA model on the post-dose minus pre-dose difference at Week 10 with the post-dose minus pre-dose difference at Baseline as a covariate.||7.60|-13.46|0.5719
72542424|NCT00272961|144614638|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.21|STANDARD_ERROR_OF_MEAN|4.33||0.3401|TWO_SIDED|95.0|-13.11|4.7|||ANCOVA|||Week 10 Standing: p-value was obtained using an ANCOVA model on the post-dose minus pre-dose difference at Week 10 with the post-dose minus pre-dose difference at Baseline as a covariate.||4.70|-13.11|0.3401
72542425|NCT00272961|144614638|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.1|STANDARD_ERROR_OF_MEAN|4.34||0.6329|TWO_SIDED|95.0|-11.01|6.82|||ANCOVA|||Week 10 Standing: p-value was obtained using an ANCOVA model on the post-dose minus pre-dose difference at Week 10 with the post-dose minus pre-dose difference at Baseline as a covariate.||6.82|-11.01|0.6329
72542426|NCT00272961|144614638|SUPERIORITY_OR_OTHER||LS Mean Difference|3.83|STANDARD_ERROR_OF_MEAN|4.51||0.4037|TWO_SIDED|95.0|-5.45|13.11|||ANCOVA|||Week 10 Standing: p-value was obtained using an ANCOVA model on the post-dose minus pre-dose difference at Week 10 with the post-dose minus pre-dose difference at Baseline as a covariate.||13.11|-5.45|0.4037
72542427|NCT00272961|144614639|SUPERIORITY_OR_OTHER||LS Mean Difference|1.21|STANDARD_ERROR_OF_MEAN|4.08||0.7685|TWO_SIDED|95.0|-7.19|9.62|||ANCOVA|||Week 10 Sitting: p-value was obtained using an ANCOVA model on the post-dose minus pre-dose difference at Week 10 with the post-dose minus pre-dose difference at Baseline as a covariate.||9.62|-7.19|0.7685
72542428|NCT00272961|144614639|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.88|STANDARD_ERROR_OF_MEAN|3.49||0.1739|TWO_SIDED|95.0|-12.07|2.3|||ANCOVA|||Week 10 Sitting: p-value was obtained using an ANCOVA model on the post-dose minus pre-dose difference at Week 10 with the post-dose minus pre-dose difference at Baseline as a covariate.||2.30|-12.07|0.1739
72542429|NCT00272961|144614639|SUPERIORITY_OR_OTHER||LS Mean Difference|2.71|STANDARD_ERROR_OF_MEAN|3.61||0.4612|TWO_SIDED|95.0|-4.74|10.15|||ANCOVA|||Week 10 Sitting: p-value was obtained using an ANCOVA model on the post-dose minus pre-dose difference at Week 10 with the post-dose minus pre-dose difference at Baseline as a covariate.||10.15|-4.74|0.4612
72542430|NCT00272961|144614639|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.34|STANDARD_ERROR_OF_MEAN|3.67||0.7172|TWO_SIDED|95.0|-8.9|6.21|||ANCOVA|||Week 10 Sitting: p-value was obtained using an ANCOVA model on the post-dose minus pre-dose difference at Week 10 with the post-dose minus pre-dose difference at Baseline as a covariate.||6.21|-8.90|0.7172
72542431|NCT00272961|144614639|SUPERIORITY_OR_OTHER||LS Mean Difference|3.45|STANDARD_ERROR_OF_MEAN|4.12||0.4098|TWO_SIDED|95.0|-5.01|11.91|||ANCOVA|||Week 10 Standing: p-value was obtained using an ANCOVA model on the post-dose minus pre-dose difference at Week 10 with the post-dose minus pre-dose difference at Baseline as a covariate.||11.91|-5.01|0.4098
72542432|NCT00272961|144614639|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.38|STANDARD_ERROR_OF_MEAN|3.48||0.6943|TWO_SIDED|95.0|-8.54|5.78|||ANCOVA|||Week 10 Standing: p-value was obtained using an ANCOVA model on the post-dose minus pre-dose difference at Week 10 with the post-dose minus pre-dose difference at Baseline as a covariate.||5.78|-8.54|0.6943
72542433|NCT00272961|144614639|SUPERIORITY_OR_OTHER||LS Mean Difference|4.78|STANDARD_ERROR_OF_MEAN|3.67||0.2042|TWO_SIDED|95.0|-2.76|12.31|||ANCOVA|||Week 10 Standing: p-value was obtained using an ANCOVA model on the post-dose minus pre-dose difference at Week 10 with the post-dose minus pre-dose difference at Baseline as a covariate.||12.31|-2.76|0.2042
72542434|NCT00272961|144614639|SUPERIORITY_OR_OTHER||LS Mean Difference|1.07|STANDARD_ERROR_OF_MEAN|3.77||0.7791|TWO_SIDED|95.0|-6.69|8.83|||ANCOVA|||Week 10 Standing: p-value was obtained using an ANCOVA model on the post-dose minus pre-dose difference at Week 10 with the post-dose minus pre-dose difference at Baseline as a covariate.||8.83|-6.69|0.7791
72542435|NCT01455545|144614655|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.999||||0.967|TWO_SIDED|95.0|0.962|1.037|||Regression, Logistic|||Ho = no differences in ASK-20 results between both groups H1= there are differences between both groups. Comparison of two means. Unilateral test. (1-alpha)=95%. Statistic power: 90%. Precision: 10. S square: 256. Sample size: 44. Sample size adjusted to losses: 46 patients.||1.037|0.962|0.967
72542436|NCT01455545|144614656|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.001||||0.861|TWO_SIDED|95.0|0.985|1.018|||Regression, Logistic|||||1.018|0.985|0.861
72542437|NCT01455545|144614657|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.625||||0.252|TWO_SIDED|95.0|0.706|3.739|||Chi-squared|||Ho = no differences in gender results between both groups H1= there are differences between both groups. Cross tab Chi square||3.739|0.706|0.252
72542438|NCT01455545|144614658|SUPERIORITY_OR_OTHER|||||||0.217||95.0|||||Chi-squared|||Ho = no differences between both groups H1= there are differences between both groups. Chi - square||||0.217
72542439|NCT01455545|144614659|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.83||||0.643|TWO_SIDED|95.0|0.376|1.829|||Chi-squared|||Ho = no differences between both groups H1= there are differences between both groups. Cross tabs Chi square||1.829|0.376|0.643
72505607|NCT01426386|144542406|OTHER|Based on the ANCOVA model the slope of the dose-response curve was estimated. Null hypothesis: Slope of dose-response curve equal to 0 (zero)|Slope of the dose-response curve|11.1|||<|0.001|TWO_SIDED|95.0|6.78|15.48||No adjustment for multiplicity was applied for the secondary endpoints|ANCOVA|Follicular volume as dependent variable, centre and AMH strata (5.0-14.9 pmol/L and 15.0-44.9 pmol/L) as factors and log(dose) as covariate||The dose-response relationship was analysed using an analysis of covariance (ANCOVA) model||15.48|6.78|<0.001
72471190|NCT00667459|144466167|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority margin is 0.1.|Risk Difference (RD)|0.099||||1|TWO_SIDED|95.0|0.038|0.161||The posterior probably of non-inferiority was calculated and presented instead of the p-value.|Bayesian logistic model|The propensity score method was used to adjust possible effects on outcomes caused by differences in baseline characteristic due to non-randomization.|The posterior mean of P1-P0, along with the corresponding 95% highest posterior density (HPD) interval was presented instead of the usual 95% CI.|"The null hypothesis H0: p1 + d ≤ p0, and the alternative hypothesis is Ha: p1 + d \> p0 where P0 and P1 are the overall success rates in the control group and the investigational group respectively, and d is the non-inferiority margin. The analyses used Bayesian methodology. Should the posterior probability P (p1 - p0 \> -d \| data) be at least 0.95, then the null non-inferiority hypothesis will be rejected, and non-inferiority of the investigational device to the control will be claimed."||0.161|0.038|1.0
72471191|NCT00667459|144466167|SUPERIORITY_OR_OTHER_LEGACY|||||||0.999||95.0||||The posterior probably of superiority was calculated and presented instead of the p-value.|Bayesian logistic model|The propensity score method was used to adjust possible effects on outcomes caused by differences in baseline characteristic due to non-randomization.||Superiority comparison of success rates in two treatment groups was a secondary objective of this trial. Superiority analysis was performed if non-inferiority was demonstrated.||||0.999
72505608|NCT01426386|144542407|OTHER|Based on the ANCOVA model the slope of the dose-response curve was estimated. Null hypothesis: Slope of dose-response curve equal to 0 (zero)|Slope of the dose-response curve|0.8|||<|0.001|TWO_SIDED|95.0|0.56|1.11||No adjustment for multiplicity was applied for the secondary endpoints|ANCOVA|Log(estradiol) as dependent variable, AMH strata (5.0-14.9 pmol/L and 15.0-44.9 pmol/L) as factor, log(dose) and log(baseline estradiol) as covariates||The dose-response relationship was analysed using an analysis of covariance (ANCOVA) model||1.11|0.56|<0.001
72505609|NCT01426386|144542409|OTHER|Based on the ANCOVA model the slope of the dose-response curve was estimated. Null hypothesis: Slope of dose-response curve equal to 0 (zero)|Slope of the dose-response curve|3.2|||<|0.001|TWO_SIDED|95.0|1.71|4.78||No adjustment for multiplicity was applied for the secondary endpoints|ANCOVA|Fertilised oocytes as dependent variable, AMH strata (5.0-14.9 pmol/L and 15.0-44.9 pmol/L) as factor and log(dose) as covariate||The dose-response relationship was analysed using an analysis of covariance (ANCOVA) model||4.78|1.71|<0.001
72505610|NCT01426386|144542411|OTHER|Treatment groups were compared using the chi-squared test.||||||0.248||||||No adjustment for multiplicity was applied for the secondary endpoints|Chi-squared|||||||0.248
72505611|NCT01096667|144542414|SUPERIORITY_OR_OTHER||Difference in least squares means|-2.97||||0.034|TWO_SIDED|80.0|-5.05|-0.89||P-value is one-sided.|ANCOVA|Based on ANCOVA with treatment as fixed effect and baseline as a covariate.||||-0.89|-5.05|0.034
72505612|NCT01096667|144542414|SUPERIORITY_OR_OTHER||Difference in least squares means|-4.0||||0.01|TWO_SIDED|80.0|-6.17|-1.82||P-value is one-sided.|ANCOVA|Based on ANCOVA with treatment as fixed effect and baseline as a covariate.||||-1.82|-6.17|0.010
72505613|NCT01096667|144542414|SUPERIORITY_OR_OTHER||Difference in least squares means|-3.69||||0.012|TWO_SIDED|80.0|-5.78|-1.6||P-value is one-sided.|ANCOVA|Based on ANCOVA with treatment as fixed effect and baseline as a covariate.||||-1.60|-5.78|0.012
72505614|NCT01096667|144542414|SUPERIORITY_OR_OTHER||Difference in least squares means|-3.21||||0.024|TWO_SIDED|80.0|-5.3|-1.13||P-value is one-sided.|ANCOVA|Based on ANCOVA with treatment as fixed effect and baseline as a covariate.||||-1.13|-5.30|0.024
72505615|NCT01096667|144542416|SUPERIORITY_OR_OTHER||Difference in least squares means|-3.7||||0.018|TWO_SIDED|80.0|-5.94|-1.46||P-value is one-sided.|ANCOVA|Based on ANCOVA with treatment as fixed effect and baseline as a covariate.||||-1.46|-5.94|0.018
72505616|NCT01096667|144542416|SUPERIORITY_OR_OTHER||Difference in least squares means|-4.43||||0.008|TWO_SIDED|80.0|-6.78|-2.09||P-value is one-sided.|ANCOVA|Based on ANCOVA with treatment as fixed effect and baseline as a covariate.||||-2.09|-6.78|0.008
72505617|NCT01096667|144542416|SUPERIORITY_OR_OTHER||Difference in least squares means|-4.99||||0.002|TWO_SIDED|80.0|-7.24|-2.74||P-value is one-sided.|ANCOVA|Based on ANCOVA with treatment as fixed effect and baseline as a covariate.||||-2.74|-7.24|0.002
72505618|NCT01096667|144542416|SUPERIORITY_OR_OTHER||Difference in least squares means|-3.92||||0.013|TWO_SIDED|80.0|-6.16|-1.67||P-value is one-sided.|ANCOVA|Based on ANCOVA with treatment as fixed effect and baseline as a covariate.||||-1.67|-6.16|0.013
72505619|NCT01096667|144542417|SUPERIORITY_OR_OTHER||Difference in least squares means|-2.19||||0.152|TWO_SIDED|80.0|-4.93|0.54||P-value is one-sided.|ANCOVA|Based on ANCOVA with treatment as fixed effect and baseline as a covariate.||||0.54|-4.93|0.152
72505620|NCT01096667|144542417|SUPERIORITY_OR_OTHER||Difference in least squares means|-3.18||||0.078|TWO_SIDED|80.0|-6.06|-0.3||P-value is one-sided.|ANCOVA|Based on ANCOVA with treatment as fixed effect and baseline as a covariate.||||-0.30|-6.06|0.078
72505621|NCT01096667|144542417|SUPERIORITY_OR_OTHER||Difference in least squares means|-2.02||||0.174|TWO_SIDED|80.0|-4.79|0.74||P-value is one-sided.|ANCOVA|Based on ANCOVA with treatment as fixed effect and baseline as a covariate.||||0.74|-4.79|0.174
72505622|NCT01096667|144542417|SUPERIORITY_OR_OTHER||Difference in least squares means|-2.01||||0.174|TWO_SIDED|80.0|-4.77|0.74||P-value is one-sided.|ANCOVA|Based on ANCOVA with treatment as fixed effect and baseline as a covariate.||||0.74|-4.77|0.174
72576677|NCT02119819|144680146|SUPERIORITY||Posterior Mean Difference|-0.78|STANDARD_ERROR_OF_MEAN|0.16||0.459|TWO_SIDED|90.0|-1.05|-0.52|||Bayesian|||||-0.52|-1.05|0.459
72576678|NCT02119819|144680146|SUPERIORITY||Posterior Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.16||0.511|TWO_SIDED|90.0|-1.07|-0.54|||Bayesian|||||-0.54|-1.07|0.511
72576679|NCT02119819|144680146|SUPERIORITY||Posterior Mean Difference|-1.15|STANDARD_ERROR_OF_MEAN|0.16||0.988|TWO_SIDED|90.0|-1.41|-0.89|||Bayesian|||||-0.89|-1.41|0.988
72576680|NCT02119819|144680146|SUPERIORITY||Posterior Mean Difference|-1.04|STANDARD_ERROR_OF_MEAN|0.16||0.934|TWO_SIDED|90.0|-1.3|-0.78|||Bayesian|||||-0.78|-1.30|0.934
72395580|NCT00137046|144297506|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.225|STANDARD_ERROR_OF_MEAN|0.089||||90.0|0.079|0.372|||ANCOVA|||Extension Month 24; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline HbA1c, and Center.||0.372|0.079|
72622863|NCT01251757|144775927|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.03|||<|0.001|TWO_SIDED|95.0|0.019|0.042|||Regression, Linear|adjusted for site, gender, age, total number of prescription medications participant is taking, comorbid diabetes/CVD, and baseline statin adherence.|Adjusted difference in adherence for IVR+ group versus UC group, calculated as IVR+ - UC.|We conducted separate primary analyses of each of IVR and IVR+ versus usual care at the .025 level of significance to assure a trial-wide error rate of .05. This analysis summary is for the IVR+ versus UC comparison only. Also, we only report results here for the full sample, and not also separately for the 3 baseline adherence level groups.||0.042|0.019|<.001
72395581|NCT00137046|144297506|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.211|STANDARD_ERROR_OF_MEAN|0.095||||90.0|0.055|0.368|||ANCOVA|||Extension Month 27; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline HbA1c, and Center.||0.368|0.055|
72395582|NCT00137046|144297506|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.331|STANDARD_ERROR_OF_MEAN|0.092||||90.0|0.18|0.483|||ANCOVA|||Extension Month 30; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline HbA1c, and Center.||0.483|0.180|
72505623|NCT01096667|144542419|SUPERIORITY_OR_OTHER||Difference in least squares means|-4.01||||0.047|TWO_SIDED|80.0|-7.09|-0.94||P-value is one-sided.|Mixed Model for Repeated Measures|With terms for treatment, visit, and treatment-by-visit interaction as fixed effects, participant as random effect and baseline as the covariate.||||-0.94|-7.09|0.047
72505624|NCT01096667|144542419|SUPERIORITY_OR_OTHER||Difference in least squares means|-7.16||||0.002|TWO_SIDED|80.0|-10.25|-4.07||P-value is one-sided.|Mixed Model for Repeated Measures|With terms for treatment, visit, and treatment-by-visit interaction as fixed effects, participant as random effect and baseline as the covariate.||||-4.07|-10.25|0.002
72505625|NCT01096667|144542419|SUPERIORITY_OR_OTHER||Difference in least squares means|-6.2||||0.005|TWO_SIDED|80.0|-9.28|-3.11||P-value is one-sided.|Mixed Model for Repeated Measures|With terms for treatment, visit, and treatment-by-visit interaction as fixed effects, participant as random effect and baseline as the covariate.||||-3.11|-9.28|0.005
72505626|NCT01096667|144542419|SUPERIORITY_OR_OTHER||Difference in least squares means|-4.37||||0.033|TWO_SIDED|80.0|-7.41|-1.33||P-value is one-sided.|Mixed Model for Repeated Measures|With terms for treatment, visit, and treatment-by-visit interaction as fixed effects, participant as random effect and baseline as the covariate.||||-1.33|-7.41|0.033
72505627|NCT01096667|144542421|SUPERIORITY_OR_OTHER||Difference in least squares means|-2.66||||0.007|TWO_SIDED|80.0|-4.03|-1.29||P-value is one-sided.|ANCOVA|Based on ANCOVA with treatment as fixed effect and baseline as a covariate. p-value is one-sided.||||-1.29|-4.03|0.007
72505628|NCT01096667|144542421|SUPERIORITY_OR_OTHER||Difference in least squares means|-3.11||||0.003|TWO_SIDED|80.0|-4.55|-1.67||P-value is one-sided.|ANCOVA|Based on ANCOVA with treatment as fixed effect and baseline as a covariate. p-value is one-sided.||||-1.67|-4.55|0.003
72505629|NCT01096667|144542421|SUPERIORITY_OR_OTHER||Difference in least squares means|-2.27||||0.018|TWO_SIDED|80.0|-3.65|-0.88||P-value is one-sided.|ANCOVA|Based on ANCOVA with treatment as fixed effect and baseline as a covariate. p-value is one-sided.||||-0.88|-3.65|0.018
72505630|NCT01096667|144542421|SUPERIORITY_OR_OTHER||Difference in least squares means|-2.19||||0.021|TWO_SIDED|80.0|-3.56|-0.82||P-value is one-sided.|ANCOVA|Based on ANCOVA with treatment as fixed effect and baseline as a covariate. p-value is one-sided.||||-0.82|-3.56|0.021
72505631|NCT01096667|144542422|SUPERIORITY_OR_OTHER||Difference in least squares means|-2.99||||0.004|TWO_SIDED|80.0|-4.43|-1.55||P-value is one-sided.|ANCOVA|Based on ANCOVA with treatment as fixed effect and baseline as a covariate. p-value is one-sided.||||-1.55|-4.43|0.004
72505632|NCT01096667|144542422|SUPERIORITY_OR_OTHER||Difference in least squares means|-2.75||||0.01|TWO_SIDED|80.0|-4.26|-1.24||P-value is one-sided.|ANCOVA|Based on ANCOVA with treatment as fixed effect and baseline as a covariate. p-value is one-sided.||||-1.24|-4.26|0.010
72505633|NCT01096667|144542422|SUPERIORITY_OR_OTHER||Difference in least squares means|-2.64||||0.01|TWO_SIDED|80.0|-4.09|-1.19||P-value is one-sided.|ANCOVA|Based on ANCOVA with treatment as fixed effect and baseline as a covariate. p-value is one-sided.||||-1.19|-4.09|0.010
72505634|NCT01096667|144542422|SUPERIORITY_OR_OTHER||Difference in least squares means|-2.57||||0.011|TWO_SIDED|80.0|-4.0|-1.13||P-value is one-sided.|ANCOVA|Based on ANCOVA with treatment as fixed effect and baseline as a covariate. p-value is one-sided.||||-1.13|-4.00|0.011
72505635|NCT01096667|144542423|SUPERIORITY_OR_OTHER||Difference in least squares means|-2.5||||0.048|TWO_SIDED|80.0|-4.43|-0.57||P-value is one-sided.|ANCOVA|Based on ANCOVA with treatment as fixed effect and baseline as a covariate.||||-0.57|-4.43|0.048
72505636|NCT01096667|144542423|SUPERIORITY_OR_OTHER||Difference in least squares means|-3.54||||0.013|TWO_SIDED|80.0|-5.58|-1.51||P-value is one-sided.|ANCOVA|Based on ANCOVA with treatment as fixed effect and baseline as a covariate.||||-1.51|-5.58|0.013
72505637|NCT01096667|144542423|SUPERIORITY_OR_OTHER||Difference in least squares means|-1.88||||0.111|TWO_SIDED|80.0|-3.82|0.09||P-value is one-sided.|ANCOVA|Based on ANCOVA with treatment as fixed effect and baseline as a covariate.||||0.09|-3.82|0.111
72505638|NCT01096667|144542423|SUPERIORITY_OR_OTHER||Difference in least squares means|-1.58||||0.148|TWO_SIDED|80.0|-3.51|0.36||P-value is one-sided.|ANCOVA|Based on ANCOVA with treatment as fixed effect and baseline as a covariate.||||0.36|-3.51|0.148
72505639|NCT01096667|144542425|SUPERIORITY_OR_OTHER||Difference in least squares means|-1.2||||0.196|TWO_SIDED|80.0|-3.01|0.6||P-value is one-sided.|Mixed Measures Repeated Model|With terms for treatment, visit, and treatment-by-visit interaction as fixed effects, participant as random effect and baseline as the covariate.||||0.60|-3.01|0.196
72505640|NCT01096667|144542425|SUPERIORITY_OR_OTHER||Difference in least squares means|-1.05||||0.229|TWO_SIDED|80.0|-2.86|0.77||P-value is one-sided.|Mixed Measures Repeated Model|With terms for treatment, visit, and treatment-by-visit interaction as fixed effects, participant as random effect and baseline as the covariate.||||0.77|-2.86|0.229
72471192|NCT00667459|144466168|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority margin is 0.1.|Risk Difference (RD)|-0.034||||0.992|TWO_SIDED|95.0|-0.085|0.021||The posterior probably of non-inferiority was calculated and presented instead of the p-value.|Bayesian logistic model|The propensity score method was used to adjust possible effects on outcomes caused by differences in baseline characteristic due to non-randomization.|The posterior mean of P1-P0, along with the corresponding 95% highest posterior density (HPD) interval was presented instead of the usual 95% CI.|"The null hypothesis H0: p1 + d ≤ p0, and the alternative hypothesis is Ha: p1 + d \> p0 where P0 and P1 are the overall success rates in the control group and the investigational group respectively, and d is the non-inferiority margin. The analyses used Bayesian methodology. Should the posterior probability P (p1 - p0 \> -d \| data) be at least 0.95, then the null non-inferiority hypothesis will be rejected, and non-inferiority of the investigational device to the control will be claimed."||0.021|-0.085|0.992
72471193|NCT00667459|144466168|SUPERIORITY_OR_OTHER_LEGACY|||||||0.097||||||The posterior probably of superiority was calculated and presented instead of the p-value.|Bayesian logistic model|The propensity score method was used to adjust possible effects on outcomes caused by differences in baseline characteristic due to non-randomization.||Superiority comparison of success rates in two treatment groups was a secondary objective of this trial. Superiority analysis was performed if non-inferiority was demonstrated.||||0.097
72471194|NCT00667459|144466169|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority margin is 0.1.|Risk Difference (RD)|-0.01||||1|TWO_SIDED|95.0|-0.043|0.023||The posterior probably of non-inferiority was calculated and presented instead of the p-value.|Bayesian logistic model|The propensity score method was used to adjust possible effects on outcomes caused by differences in baseline characteristic due to non-randomization.|The posterior mean of P1-P0, along with the corresponding 95% highest posterior density (HPD) interval was presented instead of the usual 95% CI.|"The null hypothesis H0: p1 + d ≤ p0, and the alternative hypothesis is Ha: p1 + d \> p0 where P0 and P1 are the overall success rates in the control group and the investigational group respectively, and d is the non-inferiority margin. The analyses used Bayesian methodology. Should the posterior probability P (p1 - p0 \> -d \| data) be at least 0.95, then the null non-inferiority hypothesis will be rejected, and non-inferiority of the investigational device to the control will be claimed."||0.023|-0.043|1.0
72471195|NCT00667459|144466169|SUPERIORITY_OR_OTHER_LEGACY|||||||0.273||95.0||||The posterior probably of superiority was calculated and presented instead of the p-value.|Bayesian logistic model|The propensity score method was used to adjust possible effects on outcomes caused by differences in baseline characteristic due to non-randomization.||Superiority comparison of success rates in two treatment groups was a secondary objective of this trial. Superiority analysis was performed if non-inferiority was demonstrated.||||0.273
72471196|NCT00667459|144466170|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority margin is 0.1.|Risk Difference (RD)|0.019||||1|TWO_SIDED|95.0|-0.018|0.058||The posterior probably of non-inferiority was calculated and presented instead of the p-value.|Bayesian logistic model|The propensity score method was used to adjust possible effects on outcomes caused by differences in baseline characteristic due to non-randomization.|The posterior mean of P1-P0, along with the corresponding 95% highest posterior density (HPD) interval was presented instead of the usual 95% CI.|"The null hypothesis H0: p1 + d ≤ p0, and the alternative hypothesis is Ha: p1 + d \> p0 where P0 and P1 are the overall success rates in the control group and the investigational group respectively, and d is the non-inferiority margin. The analyses used Bayesian methodology. Should the posterior probability P (p1 - p0 \> -d \| data) be at least 0.95, then the null non-inferiority hypothesis will be rejected, and non-inferiority of the investigational device to the control will be claimed."||0.058|-0.018|1.0
72395583|NCT00137046|144297506|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.462|STANDARD_ERROR_OF_MEAN|0.097||||90.0|0.302|0.622|||ANCOVA|||Extension Month 33; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline HbA1c, and Center.||0.622|0.302|
72471197|NCT00667459|144466170|SUPERIORITY_OR_OTHER_LEGACY|||||||0.845||95.0||||The posterior probably of superiority was calculated and presented instead of the p-value.|Bayesian logistic model|The propensity score method was used to adjust possible effects on outcomes caused by differences in baseline characteristic due to non-randomization.||Superiority comparison of success rates in two treatment groups was a secondary objective of this trial. Superiority analysis was performed if non-inferiority was demonstrated.||||0.845
72471198|NCT00667459|144466171|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority margin is 0.1.|Risk Difference (RD)|-0.047||||0.936|TWO_SIDED|95.0|-0.113|0.021||The posterior probably of non-inferiority was calculated and presented instead of the p-value.|Bayesian logistic model|The propensity score method was used to adjust possible effects on outcomes caused by differences in baseline characteristic due to non-randomization.|The posterior mean of P1-P0, along with the corresponding 95% highest posterior density (HPD) interval was presented instead of the usual 95% CI.|"The null hypothesis H0: p1 + d ≤ p0, and the alternative hypothesis is Ha: p1 + d \> p0 where P0 and P1 are the overall success rates in the control group and the investigational group respectively, and d is the non-inferiority margin. The analyses used Bayesian methodology. Should the posterior probability P (p1 - p0 \> -d \| data) be at least 0.95, then the null non-inferiority hypothesis will be rejected, and non-inferiority of the investigational device to the control will be claimed."||0.021|-0.113|0.936
72471199|NCT00667459|144466172|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority margin is 0.1.|Risk Difference (RD)|0.105||||1|TWO_SIDED|95.0|0.02|0.19||The posterior probably of non-inferiority was calculated and presented instead of the p-value.|Bayesian logistic model|The propensity score method was used to adjust possible effects on outcomes caused by differences in baseline characteristic due to non-randomization.|The posterior mean of P1-P0, along with the corresponding 95% highest posterior density (HPD) interval was presented instead of the usual 95% CI.|"The null hypothesis H0: p1 + d ≤ p0, and the alternative hypothesis is Ha: p1 + d \> p0 where P0 and P1 are the overall success rates in the control group and the investigational group respectively, and d is the non-inferiority margin. The analyses used Bayesian methodology. Should the posterior probability P (p1 - p0 \> -d \| data) be at least 0.95, then the null non-inferiority hypothesis will be rejected, and non-inferiority of the investigational device to the control will be claimed."||0.190|0.020|1.0
72576681|NCT02119819|144680146|SUPERIORITY||Posterior Mean Difference|0.35|STANDARD_ERROR_OF_MEAN|0.16||0.373|TWO_SIDED|90.0|0.08|0.61|||Bayesian|||||0.61|0.08|0.373
72576682|NCT02119819|144680146|SUPERIORITY||Posterior Mean Difference|0.33|STANDARD_ERROR_OF_MEAN|0.16||0.433|TWO_SIDED|90.0|0.07|0.59|||Bayesian|||||0.59|0.07|0.433
72395584|NCT00137046|144297506|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.41|STANDARD_ERROR_OF_MEAN|0.115||||90.0|0.221|0.6|||ANCOVA|||Extension Month 36; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline HbA1c, and Center.||0.600|0.221|
72395585|NCT00137046|144297506|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.451|STANDARD_ERROR_OF_MEAN|0.161||||90.0|0.183|0.718|||ANCOVA|||Extension Month 39; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline HbA1c, and Center.||0.718|0.183|
72395586|NCT00137046|144297506|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.032|STANDARD_ERROR_OF_MEAN|0.124||||90.0|-0.174|0.237|||ANCOVA|||Extension Follow Up Month 3; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline HbA1c, and Center.||0.237|-0.174|
72395587|NCT00137046|144297509|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.81|STANDARD_ERROR_OF_MEAN|6.33||||90.0|-25.24|-4.39|||ANCOVA|||Month 3; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Fasting Plasma Glucose, and Center.||-4.39|-25.24|
72395588|NCT00137046|144297509|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-24.83|STANDARD_ERROR_OF_MEAN|6.27||||90.0|-35.16|-14.51|||ANCOVA|||Month 6; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Fasting Plasma Glucose, and Center.||-14.51|-35.16|
72395589|NCT00137046|144297509|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-26.16|STANDARD_ERROR_OF_MEAN|6.92||||90.0|-37.56|-14.75|||ANCOVA|||Month 9; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Fasting Plasma Glucose, and Center.||-14.75|-37.56|
72395590|NCT00137046|144297509|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.46|STANDARD_ERROR_OF_MEAN|6.74||||90.0|-30.56|-8.36|||ANCOVA|||Month 12; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Fasting Plasma Glucose, and Center.||-8.36|-30.56|
72395591|NCT00137046|144297509|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-39.97|STANDARD_ERROR_OF_MEAN|6.65||||90.0|-50.93|-29.0|||ANCOVA|||Month 15; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Fasting Plasma Glucose, and Center.||-29.00|-50.93|
72395592|NCT00137046|144297509|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.08|STANDARD_ERROR_OF_MEAN|7.02||||90.0|-27.65|-4.51|||ANCOVA|||Month 18; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Fasting Plasma Glucose, and Center.||-4.51|-27.65|
72395593|NCT00137046|144297509|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.54|STANDARD_ERROR_OF_MEAN|6.76||||90.0|-24.69|-2.39|||ANCOVA|||Month 21; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Fasting Plasma Glucose, and Center.||-2.39|-24.69|
72395594|NCT00137046|144297509|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-18.86|STANDARD_ERROR_OF_MEAN|7.29||||90.0|-30.88|-6.84|||ANCOVA|||Month 24; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Fasting Plasma Glucose, and Center.||-6.84|-30.88|
72395595|NCT00137046|144297509|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.56|STANDARD_ERROR_OF_MEAN|8.12||||90.0|-9.83|16.96|||ANCOVA|||Follow-up Month 6; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin.Adjusted model includes terms of Treatment, Baseline Fasting Plasma Glucose, and Center.||16.96|-9.83|
72395596|NCT00137046|144297509|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.8|STANDARD_ERROR_OF_MEAN|8.2||||90.0|-31.32|-4.27|||ANCOVA|||Extension Month 1; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Fasting Plasma Glucose, and Center.||-4.27|-31.32|
72471200|NCT00667459|144466172|SUPERIORITY_OR_OTHER_LEGACY|||||||0.992||95.0||||The posterior probably of superiority was calculated and presented instead of the p-value.|Bayesian logistic model|The propensity score method was used to adjust possible effects on outcomes caused by differences in baseline characteristic due to non-randomization.||Superiority comparison of success rates in two treatment groups was a secondary objective of this trial. Superiority analysis was performed if non-inferiority was demonstrated.||||0.992
72505641|NCT01096667|144542425|SUPERIORITY_OR_OTHER||Difference in least squares means|-3.02||||0.017|TWO_SIDED|80.0|-4.83|-1.2||P-value is one-sided.|Mixed Measures Repeated Model|With terms for treatment, visit, and treatment-by-visit interaction as fixed effects, participant as random effect and baseline as the covariate.||||-1.20|-4.83|0.017
72505642|NCT01096667|144542425|SUPERIORITY_OR_OTHER||Difference in least squares means|-2.84||||0.021|TWO_SIDED|80.0|-4.63|-1.06||P-value is one-sided.|Mixed Measures Repeated Model|With terms for treatment, visit, and treatment-by-visit interaction as fixed effects, participant as random effect and baseline as the covariate.||||-1.06|-4.63|0.021
72395597|NCT00137046|144297509|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-20.71|STANDARD_ERROR_OF_MEAN|7.72||||90.0|-33.44|-7.99|||ANCOVA|||Extension Month 3; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Fasting Plasma Glucose, and Center.||-7.99|-33.44|
72395598|NCT00137046|144297509|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.8|STANDARD_ERROR_OF_MEAN|7.8||||90.0|-11.06|14.66|||ANCOVA|||Extension Month 6; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Fasting Plasma Glucose, and Center.||14.66|-11.06|
72395599|NCT00137046|144297509|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.72|STANDARD_ERROR_OF_MEAN|9.02||||90.0|-23.61|6.17|||ANCOVA|||Extension Month 9; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Fasting Plasma Glucose, and Center.||6.17|-23.61|
72395600|NCT00137046|144297509|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.34|STANDARD_ERROR_OF_MEAN|7.84||||90.0|-29.28|-3.4|||ANCOVA|||Extension Month 12; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Fasting Plasma Glucose, and Center.||-3.40|-29.28|
72395601|NCT00137046|144297509|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.99|STANDARD_ERROR_OF_MEAN|8.25||||90.0|-26.6|0.63|||ANCOVA|||Extension Month 15; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Fasting Plasma Glucose, and Center.||0.63|-26.60|
72471201|NCT00667459|144466174|SUPERIORITY_OR_OTHER_LEGACY|||||||0.013||||||The posterior probably of superiority was calculated and presented instead of the p-value.|Bayesian logistic model|||Superiority comparison of the operative time in two treatment groups was assessed.||||0.013
72505643|NCT01096667|144542427|SUPERIORITY_OR_OTHER||Difference in least squares means|-2.22||||0.039|TWO_SIDED|80.0|-3.83|-0.61||P-value is one-sided.|ANCOVA|Based on ANCOVA with treatment as fixed effect and baseline as a covariate.||||-0.61|-3.83|0.039
72505644|NCT01096667|144542427|SUPERIORITY_OR_OTHER||Difference in least squares means|0.07||||0.521|TWO_SIDED|80.0|-1.63|1.77||P-value is one-sided.|ANCOVA|Based on ANCOVA with treatment as fixed effect and baseline as a covariate.||||1.77|-1.63|0.521
72395602|NCT00137046|144297509|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.22|STANDARD_ERROR_OF_MEAN|8.58||||90.0|-24.39|3.94|||ANCOVA|||Extension Month 18; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Fasting Plasma Glucose, and Center.||3.94|-24.39|
72471202|NCT00667459|144466175|SUPERIORITY_OR_OTHER_LEGACY|||||||0.769||||||The posterior probably of superiority was calculated and presented instead of the p-value.|Bayesian logistic model|||Superiority comparison of the blood loss in two treatment groups was assessed.||||0.769
72471203|NCT00667459|144466176|SUPERIORITY_OR_OTHER_LEGACY|||||||0.273||||||The posterior probably of superiority was calculated and presented instead of the p-value.|Bayesian logistic model|||Superiority comparison of the hospital stay in two treatment groups was assessed.||||0.273
72471204|NCT04546217|144466192|SUPERIORITY|Since this is a descriptive analysis, no power calculation was conducted.||||||||||||||||Considering the small sample size, a descriptive analysis of means and standard deviations was conducted comparing scores obtained on pre-, post-treatment, at the 3- and 6-month follow up assessments visits.|A descriptive analysis of means and standard deviations was conducted comparing scores obtained on pre-, post-treatment, at the 3- and 6-month follow up assessments visits. Changes in the scores obtained on all time points compared to pre-treatment were also identified.|||
72471205|NCT04546217|144466193|OTHER|Since this is a descriptive analysis, no power calculation was conducted.||||||||||||||||Considering the small sample size, a descriptive analysis of means and standard deviations was conducted comparing scores obtained on pre-, post-treatment, at the 3- and 6-month follow up assessments visits.|A descriptive analysis of means and standard deviations was conducted comparing scores obtained on pre-, post-treatment, at the 3- and 6-month follow up assessment visits. Changes in the scores obtained on all time points compared to pre-treatment were also identified.|||
72471206|NCT04546217|144466194|OTHER|A descriptive analysis of means and standard deviations was conducted comparing scores obtained on pre-, post-treatment, at the 3- and 6-month follow up assessments visits.||||||||||||||||Considering the small sample size, a descriptive analysis of means and standard deviations was conducted comparing scores obtained on pre-, post-treatment, at the 3- and 6-month follow up assessments visits.|A descriptive analysis of means and standard deviations was conducted comparing scores obtained on pre-, post-treatment, at the 3- and 6-month follow up assessment visits. Changes in the scores obtained on all time points compared to pre-treatment were also identified.|||
72471207|NCT04546217|144466195|OTHER|A descriptive analysis of means and standard deviations was conducted comparing scores obtained on pre-, post-treatment, at the 3- and 6-month follow up assessments visits. Changes in scores post-treatment vs. pre-treatment, and 3 and 6-month follow up vs. post-treatment were calculated.|||||||||||||||||A descriptive analysis of means and standard deviations was conducted comparing scores obtained on pre-, post-treatment, at the 3- and 6-month follow up assessment visits. Changes in the scores obtained on all time points compared to pre-treatment were also identified.|||
72471208|NCT04546217|144466196|OTHER|A descriptive analysis of means and standard deviations was conducted comparing scores obtained on pre-, post-treatment, at the 3- and 6-month follow up assessments visits. Changes in scores post-treatment vs. pre-treatment, and 3 and 6-month follow up vs. post-treatment were calculated.|||||||||||||||||A descriptive analysis of means and standard deviations was conducted comparing scores obtained on pre-, post-treatment, at the 3- and 6-month follow up assessment visits. Changes in the scores obtained on all time points compared to pre-treatment were also identified.|||
72471209|NCT04546217|144466197|OTHER|A descriptive analysis of means and standard deviations was conducted comparing scores obtained on pre-, post-treatment, at the 3- and 6-month follow up assessments visits. Changes in scores post-treatment vs. pre-treatment, and 3 and 6-month follow up vs. post-treatment were calculated.|||||||||||||||||A descriptive analysis of means and standard deviations was conducted comparing scores obtained on pre-, post-treatment, at the 3- and 6-month follow up assessment visits. Changes in the scores obtained on all time points compared to pre-treatment were also identified.|||
72505645|NCT01096667|144542427|SUPERIORITY_OR_OTHER||Difference in least squares means|-2.39||||0.031|TWO_SIDED|80.0|-4.02|-0.75||P-value is one-sided.|ANCOVA|Based on ANCOVA with treatment as fixed effect and baseline as a covariate.||||-0.75|-4.02|0.031
72505646|NCT01096667|144542427|SUPERIORITY_OR_OTHER||Difference in least squares means|-1.56||||0.11|TWO_SIDED|80.0|-3.19|0.07||P-value is one-sided.|ANCOVA|Based on ANCOVA with treatment as fixed effect and baseline as a covariate.||||0.07|-3.19|0.110
72505647|NCT01096667|144542428|SUPERIORITY_OR_OTHER||Difference in least squares means|-3.38||||0.007|TWO_SIDED|80.0|-5.13|-1.63||P-value is one-sided.|ANCOVA|Based on ANCOVA with treatment as fixed effect and baseline as a covariate.||||-1.63|-5.13|0.007
72505648|NCT01096667|144542428|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.48||||0.37|TWO_SIDED|80.0|-2.33|1.38||P-value is one-sided.|ANCOVA|Based on ANCOVA with treatment as fixed effect and baseline as a covariate.||||1.38|-2.33|0.370
72505649|NCT01096667|144542428|SUPERIORITY_OR_OTHER||Difference in least squares means|-2.65||||0.029|TWO_SIDED|80.0|-4.43|-0.87||P-value is one-sided.|ANCOVA|Based on ANCOVA with treatment as fixed effect and baseline as a covariate.||||-0.87|-4.43|0.029
72471210|NCT01888874|144466231|SUPERIORITY||Difference in percentage rates|11.9||||0.1236|TWO_SIDED|95.0|-3.1|26.9|||Regression, Logistic|P-value has been corrected for multiplicity according to Hommel's closed-testing method.||Pairwise comparisons of each group vs. the placebo group using a logistic regression model with factors treatment group, geographical region, and prior use of biologics.||26.9|-3.1|0.1236
72505650|NCT01096667|144542428|SUPERIORITY_OR_OTHER||Difference in least squares means|-1.64||||0.118|TWO_SIDED|80.0|-3.42|0.13||P-value is one-sided.|ANCOVA|Based on ANCOVA with treatment as fixed effect and baseline as a covariate.||||0.13|-3.42|0.118
72505651|NCT01096667|144542429|SUPERIORITY_OR_OTHER||Difference in least squares means|0.02||||0.506|TWO_SIDED|80.0|-1.96|2.0||P-value is one-sided.|ANCOVA|Based on ANCOVA with treatment as fixed effect and baseline as a covariate.||||2.00|-1.96|0.506
72395603|NCT00137046|144297509|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-28.64|STANDARD_ERROR_OF_MEAN|8.82||||90.0|-43.19|-14.09|||ANCOVA|||Extension Month 21; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Fasting Plasma Glucose, and Center.||-14.09|-43.19|
72471211|NCT01888874|144466231|SUPERIORITY||Difference in percentage rates|19.3||||0.0435|TWO_SIDED|95.0|4.7|34.0||P-value has been corrected for multiplicity according to Hommel's closed-testing method.|Regression, Logistic|||Pairwise comparisons of each group vs. the placebo group using a logistic regression model with factors treatment group, geographical region, and prior use of biologics.||34|4.7|0.0435
72471212|NCT01888874|144466231|SUPERIORITY||Difference in percentage rates|24.4||||0.0068|TWO_SIDED|95.0|10.1|38.8||P-value has been corrected for multiplicity according to Hommel's closed-testing method.|Regression, Logistic|||Pairwise comparisons of each group vs. the placebo group using a logistic regression model with factors treatment group, geographical region, and prior use of biologics.||38.8|10.1|0.0068
72471213|NCT01888874|144466231|SUPERIORITY||Difference in percentage rates|12.8||||0.1236|TWO_SIDED|95.0|-2.0|27.6||P-value has been corrected for multiplicity according to Hommel's closed-testing method.|Regression, Logistic|||Pairwise comparisons of each group vs. the placebo group using a logistic regression model with factors treatment group, geographical region, and prior use of biologics.||27.6|-2|0.1236
72471214|NCT01888874|144466231|SUPERIORITY||Difference in percentage rates|15.8||||0.1056|TWO_SIDED|95.0|1.0|30.6||P-value has been corrected for multiplicity according to Hommel's closed-testing method.|Regression, Logistic|||Pairwise comparisons of each group vs. the placebo group using a logistic regression model with factors treatment group, geographical region, and prior use of biologics.||30.6|1|0.1056
72471215|NCT01888874|144466231|SUPERIORITY||Difference in percentage rates|34.4|||<|0.0001|TWO_SIDED|95.0|20.7|48.1||P-value has been corrected for multiplicity according to Hommel's closed-testing method.|Regression, Logistic|||Pairwise comparisons of each group vs. the placebo group using a logistic regression model with factors treatment group, geographical region, and prior use of biologics.||48.1|20.7|< 0.0001
72471216|NCT02980042|144466243|SUPERIORITY||Risk Ratio (RR)|0.6616||||0.1996|TWO_SIDED|95.0|0.3666|1.1942|||Generalized estimating equations|GEE was necessary because there are repeated measures on subjects.|This is comparing the Switching group to the Comparator group|||1.1942|.3666|0.1996
72471217|NCT02980042|144466244|SUPERIORITY||Risk Ratio (RR)|1.0||||1|TWO_SIDED|95.0|0.5299|1.8872|||Generalized estimating equations|GEE was used because there are repeated measures on subjects|Comparing Switching group Day 1 to combined Comparator group|||1.8872|.5299|1.0000
72471218|NCT02980042|144466244|SUPERIORITY||Risk Ratio (RR)|0.2857||||0.0053|TWO_SIDED|95.0|0.1006|0.8114|||Generalized estimating equations|GEE was used because there are repeated measures on subjects.|Switching group Day 15 was compared to combined Comparator group.|||.8114|.1006|0.0053
72471219|NCT02980042|144466244|SUPERIORITY||Risk Ratio (RR)|0.8571||||0.6474|TWO_SIDED|95.0|0.4385|1.6753|||Generalized estimating equations|GEE was used because there are repeated measures on subjects.||||1.6753|.4385|0.6474
72471220|NCT02980042|144466248|SUPERIORITY||Risk Ratio (RR)|0.2857||||0.0075|TWO_SIDED|95.0|0.1072|0.7613|||Generalized estimating equations|GEE was used because there are repeated measures on subjects.||||.7613|.1072|0.0075
72471221|NCT02980042|144466248|SUPERIORITY||Risk Ratio (RR)|0.8571||||0.593|TWO_SIDED|95.0|0.4868|1.5093|||Generalized estimating equations|GEE was used because there are repeated measures on subjects.||||1.5093|.4868|0.5930
72471222|NCT02980042|144466248|SUPERIORITY||Risk Ratio (RR)|3.0||||0.0209|TWO_SIDED|95.0|1.126|7.9932|||Generalized estimating equations|GEE was used because there are repeated measures on subjects.||||7.9932|1.1260|0.0209
72471223|NCT02980042|144466253|OTHER||Mean Difference (Net)|0.0||||0.005|TWO_SIDED|95.0|-27.05|-5.01||Controlled for the false discovery rate (alpha = 0.05) for all cytokines on day 1 using the Benjamini-Hochberg procedure.|t-test, 2 sided|Paired T-test. Degrees of freedom = 99.|Mean of post minus pre.|Paired T-test for change in means. Null hypothesis: no pre-post difference.||-5.01|-27.05|0.005
72471224|NCT02980042|144466254|OTHER||Mean Difference (Net)|2.55|||<|0.0001|TWO_SIDED|95.0|1.54|3.56||Controlled for the false discovery rate (alpha = 0.05) for all cytokines on day 1 using the Benjamini-Hochberg procedure.|t-test, 2 sided|Paired T-test. Degrees of freedom = 99.|Mean of post minus pre.|Paired T-test for change in means. Null hypothesis: no pre-post difference.||3.56|1.54|<0.0001
72471225|NCT02980042|144466255|OTHER||Median Difference (Net)|8.58|||<|0.0001|TWO_SIDED|95.0|6.33|10.82||Controlled for the false discovery rate (alpha = 0.05) for all cytokines on day 1 using the Benjamini-Hochberg procedure.|t-test, 2 sided|Paired T-test. Degrees of freedom = 99.|Mean of post minus pre.|Paired T-test for change in means. Null hypothesis: no pre-post difference.||10.82|6.33|<0.0001
72471226|NCT02980042|144466256|OTHER||Mean Difference (Net)|-7.37|||<|0.0001|TWO_SIDED|95.0|-10.19|-4.55||Controlled for the false discovery rate (alpha = 0.05) for all cytokines on day 1 using the Benjamini-Hochberg procedure.|t-test, 2 sided|Paired T-test. Degrees of freedom = 99.|Mean of post minus pre.|Paired T-test for change in means. Null hypothesis: no pre-post difference.||-4.55|-10.19|<0.0001
72471227|NCT02980042|144466257|OTHER||Mean Difference (Net)|44.32|||<|0.0001|TWO_SIDED|95.0|29.59|59.05||Controlled for the false discovery rate (alpha = 0.05) for all cytokines on day 1 using the Benjamini-Hochberg procedure.|t-test, 2 sided|Paired T-test. Degrees of freedom = 99.|Mean of post minus pre.|Paired T-test for change in means. Null hypothesis: no pre-post difference.||59.05|29.59|<0.0001
72471228|NCT02980042|144466258|OTHER||Mean Difference (Net)|353.35||||0.0002|TWO_SIDED|95.0|175.23|531.46||Controlled for the false discovery rate (alpha = 0.05) for all cytokines on day 1 using the Benjamini-Hochberg procedure.|t-test, 2 sided|Paired T-test. Degrees of freedom = 99.|Mean of post minus pre.|Paired T-test for change in means. Null hypothesis: no pre-post difference.||531.46|175.23|0.0002
72471229|NCT02980042|144466259|OTHER||Mean Difference (Net)|176.9|||<|0.0001|TWO_SIDED|95.0|124.5|229.31||Controlled for the false discovery rate (alpha = 0.05) for all cytokines on day 1 using the Benjamini-Hochberg procedure.|t-test, 2 sided|Paired T-test. Degrees of freedom = 99.|Mean of post minus pre.|Paired T-test for change in means. Null hypothesis: no pre-post difference.||229.31|124.50|<0.0001
72471230|NCT02980042|144466260|OTHER||Mean Difference (Net)|0.19||||0.002|TWO_SIDED|95.0|0.07|0.32||Controlled for the false discovery rate (alpha = 0.05) for all cytokines on day 1 using the Benjamini-Hochberg procedure.|t-test, 2 sided|Paired T-test. Degrees of freedom = 99.|Mean of post minus pre.|Paired T-test for change in means. Null hypothesis: no pre-post difference.||0.32|0.07|0.0020
72395604|NCT00137046|144297509|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.99|STANDARD_ERROR_OF_MEAN|8.91||||90.0|-23.69|5.71|||ANCOVA|||Extension Month 24; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Fasting Plasma Glucose, and Center.||5.71|-23.69|
72395605|NCT00137046|144297509|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.52|STANDARD_ERROR_OF_MEAN|8.8||||90.0|-24.04|5.0|||ANCOVA|||Extension Month 27; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Fasting Plasma Glucose, and Center.||5.00|-24.04|
72395606|NCT00137046|144297509|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.4|STANDARD_ERROR_OF_MEAN|8.67||||90.0|-24.71|3.92|||ANCOVA|||Extension Month 30; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Fasting Plasma Glucose, and Center.||3.92|-24.71|
72395607|NCT00137046|144297509|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.17|STANDARD_ERROR_OF_MEAN|9.24||||90.0|-21.42|9.09|||ANCOVA|||Extension Month 33; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Fasting Plasma Glucose, and Center.||9.09|-21.42|
72395608|NCT00137046|144297509|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.39|STANDARD_ERROR_OF_MEAN|9.44||||90.0|-20.98|10.21|||ANCOVA|||Extension Month 36; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Fasting Plasma Glucose, and Center.||10.21|-20.98|
72395609|NCT00137046|144297509|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.58|STANDARD_ERROR_OF_MEAN|13.77||||90.0|-38.43|7.26|||ANCOVA|||Extension Month 39; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Fasting Plasma Glucose, and Center.||7.26|-38.43|
72395610|NCT00137046|144297509|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.84|STANDARD_ERROR_OF_MEAN|11.27||||90.0|-15.79|21.46|||ANCOVA|||Extension Follow Up Month 3; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Fasting Plasma Glucose, and Center.||21.46|-15.79|
72395611|NCT00137046|144297510|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.523|STANDARD_ERROR_OF_MEAN|0.196||||90.0|-0.846|-0.199|||ANCOVA|||Month 3; Treatment-Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Body Weight, and Center.||-0.199|-0.846|
72471231|NCT02980042|144466261|OTHER||Mean Difference (Net)|0.55|||<|0.0001|TWO_SIDED|95.0|0.32|0.77||Controlled for the false discovery rate (alpha = 0.05) for all cytokines on day 1 using the Benjamini-Hochberg procedure.|t-test, 2 sided|Paired T-test. Degrees of freedom = 99.|Mean of post minus pre.|Paired T-test for change in means. Null hypothesis: no pre-post difference.||0.77|0.32|<0.0001
72471232|NCT02980042|144466262|OTHER||Mean Difference (Net)|-46.16||||0.0091|TWO_SIDED|95.0|-80.61|-11.72||Controlled for the false discovery rate (alpha = 0.05) for all cytokines on day 1 using the Benjamini-Hochberg procedure.|t-test, 2 sided|Paired T-test. Degrees of freedom = 99.|Mean of post minus pre.|Paired T-test for change in means. Null hypothesis: no pre-post difference.||-11.72|-80.61|0.0091
72471233|NCT02980042|144466263|OTHER||Mean Difference (Net)|55.26||||0.0002|TWO_SIDED|95.0|27.0|83.52||Controlled for the false discovery rate (alpha = 0.05) for all cytokines on day 1 using the Benjamini-Hochberg procedure.|t-test, 2 sided|Paired T-test. Degrees of freedom = 99.|Mean of post minus pre.|Paired T-test for change in means. Null hypothesis: no pre-post difference.||83.52|27.00|0.0002
72471234|NCT02980042|144466264|OTHER||Mean Difference (Net)|-17.24||||0.0044|TWO_SIDED|95.0|-28.96|-5.51||Controlled for the false discovery rate (alpha = 0.05) for all cytokines on day 1 using the Benjamini-Hochberg procedure.|t-test, 2 sided|Paired T-test. Degrees of freedom = 99.|Mean of post minus pre.|Paired T-test for change in means. Null hypothesis: no pre-post difference.||-5.51|-28.96|0.0044
72471235|NCT02980042|144466265|OTHER||Mean Difference (Net)|16.01|||<|0.0001|TWO_SIDED|95.0|9.75|22.28||Controlled for the false discovery rate (alpha = 0.05) for all cytokines on day 1 using the Benjamini-Hochberg procedure.|t-test, 2 sided|Paired T-test. Degrees of freedom = 99.|Mean of post minus pre.|Paired T-test for change in means. Null hypothesis: no pre-post difference.||22.28|9.75|<0.0001
72471236|NCT02980042|144466266|OTHER||Mean Difference (Net)|429.08|||<|0.0001|TWO_SIDED|95.0|296.07|562.1||Controlled for the false discovery rate (alpha = 0.05) for all cytokines on day 1 using the Benjamini-Hochberg procedure.|t-test, 2 sided|Paired T-test. Degrees of freedom = 99.|Mean of post minus pre.|Paired T-test for change in means. Null hypothesis: no pre-post difference.||562.10|296.07|<0.0001
72471237|NCT02980042|144466267|OTHER||Mean Difference (Net)|1.23||||0.0101|TWO_SIDED|95.0|0.3|2.16||Controlled for the false discovery rate (alpha = 0.05) for all cytokines on day 1 using the Benjamini-Hochberg procedure.|t-test, 2 sided|Paired T-test. Degrees of freedom = 99.|Mean of post minus pre.|Paired T-test for change in means. Null hypothesis: no pre-post difference.||2.16|0.30|0.0101
72505652|NCT01096667|144542429|SUPERIORITY_OR_OTHER||Difference in least squares means|1.61||||0.838|TWO_SIDED|80.0|-0.49|3.71||P-value is one-sided.|ANCOVA|Based on ANCOVA with treatment as fixed effect and baseline as a covariate.||||3.71|-0.49|0.838
72395612|NCT00137046|144297510|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.113|STANDARD_ERROR_OF_MEAN|0.26||||90.0|-1.541|-0.685|||ANCOVA|||Month 6; Treatment-Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Body Weight, and Center.||-0.685|-1.541|
72395613|NCT00137046|144297510|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.359|STANDARD_ERROR_OF_MEAN|0.29||||90.0|-1.836|-0.882|||ANCOVA|||Month 9; Treatment-Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Body Weight, and Center.||-0.882|-1.836|
72395614|NCT00137046|144297510|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.184|STANDARD_ERROR_OF_MEAN|0.314||||90.0|-1.702|-0.666|||ANCOVA|||Month 12; Treatment-Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Body Weight, and Center.||-0.666|-1.702|
72395615|NCT00137046|144297510|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.426|STANDARD_ERROR_OF_MEAN|0.338||||90.0|-1.984|-0.869|||ANCOVA|||Month 15; Treatment-Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Body Weight, and Center.||-0.869|-1.984|
72395616|NCT00137046|144297510|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.717|STANDARD_ERROR_OF_MEAN|0.384||||90.0|-2.35|-1.084|||ANCOVA|||Month 18; Treatment-Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Body Weight, and Center.||-1.084|-2.350|
72471238|NCT02980042|144466268|OTHER||Mean Difference (Net)|8.69|||<|0.0001|TWO_SIDED|95.0|4.87|12.52||Controlled for the false discovery rate (alpha = 0.05) for all cytokines on day 1 using the Benjamini-Hochberg procedure.|t-test, 2 sided|Paired T-test. Degrees of freedom = 99.|Mean of post minus pre.|Paired T-test for change in means. Null hypothesis: no pre-post difference.||12.52|4.87|<0.0001
72395617|NCT00137046|144297510|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.273|STANDARD_ERROR_OF_MEAN|0.411||||90.0|-1.95|-0.596|||ANCOVA|||Month 21; Treatment-Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Body Weight, and Center.||-0.596|-1.950|
72471239|NCT02980042|144466269|OTHER||Mean Difference (Net)|1.53|||<|0.0001|TWO_SIDED|95.0|1.04|2.03||Controlled for the false discovery rate (alpha = 0.05) for all cytokines on day 1 using the Benjamini-Hochberg procedure.|t-test, 2 sided|Paired T-test. Degrees of freedom = 99.|Mean of post minus pre.|Paired T-test for change in means. Null hypothesis: no pre-post difference.||2.03|1.04|<0.0001
72471240|NCT02980042|144466270|OTHER||Mean Difference (Net)|-33.17|||<|0.0001|TWO_SIDED|95.0|-38.91|-27.44||99 patients with non-missing change scores used. Controlled for the false discovery rate (alpha = 0.05) for all cytokines on day 15 using the Benjamini-Hochberg procedure.|t-test, 2 sided|Paired T-test. Degrees of freedom = 98.|Mean of post minus pre. 99 usable change scores.|Paired T-test for change in means. Null hypothesis: no pre-post difference.||-27.44|-38.91|<0.0001
72471241|NCT02980042|144466271|OTHER||Mean Difference (Net)|-0.62||||0.0008|TWO_SIDED|95.0|-0.98|-0.26||99 patients with non-missing change scores used. Controlled for the false discovery rate (alpha = 0.05) for all cytokines on day 15 using the Benjamini-Hochberg procedure.|t-test, 2 sided|Paired T-test. Degrees of freedom = 98.|Mean of post minus pre. 99 usable change scores.|Paired T-test for change in means. Null hypothesis: no pre-post difference.||-0.26|-0.98|0.0008
72471242|NCT02980042|144466272|OTHER||Mean Difference (Net)|2.01|||<|0.0001|TWO_SIDED|95.0|1.23|2.79||99 patients with non-missing change scores used. Controlled for the false discovery rate (alpha = 0.05) for all cytokines on day 15 using the Benjamini-Hochberg procedure.|t-test, 2 sided|Paired T-test. Degrees of freedom = 98.|Mean of post minus pre. 99 usable change scores.|Paired T-test for change in means. Null hypothesis: no pre-post difference.||2.79|1.23|<0.0001
72505653|NCT01096667|144542429|SUPERIORITY_OR_OTHER||Difference in least squares means|-1.82||||0.123|TWO_SIDED|80.0|-3.82|0.19||P-value is one-sided.|ANCOVA|Based on ANCOVA with treatment as fixed effect and baseline as a covariate.||||0.19|-3.82|0.123
72471243|NCT02980042|144466273|OTHER||Mean Difference (Net)|-7.84|||<|0.0001|TWO_SIDED|95.0|-9.87|-5.81||99 patients with non-missing change scores used. Controlled for the false discovery rate (alpha = 0.05) for all cytokines on day 15 using the Benjamini-Hochberg procedure.|t-test, 2 sided|Paired T-test. Degrees of freedom = 98.|Mean of post minus pre. 99 usable change scores.|Paired T-test for change in means. Null hypothesis: no pre-post difference.||-5.81|-9.87|<0.0001
72471244|NCT02980042|144466274|OTHER||Mean Difference (Net)|-14.2||||0.0022|TWO_SIDED|95.0|-23.15|-5.25||99 patients with non-missing change scores used. Controlled for the false discovery rate (alpha = 0.05) for all cytokines on day 15 using the Benjamini-Hochberg procedure.|t-test, 2 sided|Paired T-test. Degrees of freedom = 98.|Mean of post minus pre. 99 usable change scores.|Paired T-test for change in means. Null hypothesis: no pre-post difference.||-5.25|-23.15|0.0022
72471245|NCT02980042|144466275|OTHER||Mean Difference (Net)|0.3|||<|0.0001|TWO_SIDED|95.0|0.17|0.43||99 patients with non-missing change scores used. Controlled for the false discovery rate (alpha = 0.05) for all cytokines on day 15 using the Benjamini-Hochberg procedure.|t-test, 2 sided|Paired T-test. Degrees of freedom = 98.|Mean of post minus pre. 99 usable change scores.|Paired T-test for change in means. Null hypothesis: no pre-post difference.||0.43|0.17|<0.0001
72471246|NCT02980042|144466276|OTHER||Mean Difference (Net)|0.41|||<|0.0001|TWO_SIDED|95.0|0.22|0.61||99 patients with non-missing change scores used. Controlled for the false discovery rate (alpha = 0.05) for all cytokines on day 15 using the Benjamini-Hochberg procedure.|t-test, 2 sided|Paired T-test. Degrees of freedom = 98.|Mean of post minus pre. 99 usable change scores.|Paired T-test for change in means. Null hypothesis: no pre-post difference.||0.61|0.22|<0.0001
72471247|NCT02980042|144466277|OTHER||Mean Difference (Net)|-0.72|||<|0.0001|TWO_SIDED|95.0|-0.95|-0.5||99 patients with non-missing change scores used. Controlled for the false discovery rate (alpha = 0.05) for all cytokines on day 15 using the Benjamini-Hochberg procedure.|t-test, 2 sided|Paired T-test. Degrees of freedom = 98.|Mean of post minus pre. 99 usable change scores.|Paired T-test for change in means. Null hypothesis: no pre-post difference.||-0.50|-0.95|<0.0001
72471248|NCT02980042|144466278|OTHER||Mean Difference (Net)|-19.31|||<|0.0001|TWO_SIDED|95.0|-22.64|-15.98||99 patients with non-missing change scores used. Controlled for the false discovery rate (alpha = 0.05) for all cytokines on day 15 using the Benjamini-Hochberg procedure.|t-test, 2 sided|Paired T-test. Degrees of freedom = 98.|Mean of post minus pre. 99 usable change scores.|Paired T-test for change in means. Null hypothesis: no pre-post difference.||-15.98|-22.64|<0.0001
72471249|NCT02980042|144466279|OTHER||Mean Difference (Net)|-6.96|||<|0.0001|TWO_SIDED|95.0|-9.85|-4.08||99 patients with non-missing change scores used. Controlled for the false discovery rate (alpha = 0.05) for all cytokines on day 15 using the Benjamini-Hochberg procedure.|t-test, 2 sided|Paired T-test. Degrees of freedom = 98.|Mean of post minus pre. 99 usable change scores.|Paired T-test for change in means. Null hypothesis: no pre-post difference.||-4.08|-9.85|<0.0001
72505654|NCT01096667|144542429|SUPERIORITY_OR_OTHER||Difference in least squares means|-1.07||||0.246|TWO_SIDED|80.0|-3.06|0.93||P-value is one-sided.|ANCOVA|Based on ANCOVA with treatment as fixed effect and baseline as a covariate.||||0.93|-3.06|0.246
72505655|NCT01096667|144542431|SUPERIORITY_OR_OTHER||Difference in least squares means|-4.2||||0.005|TWO_SIDED|80.0|-6.3|-2.1||P-value is one-sided.|Mixed Model for Repeated Measures|With terms for treatment, visit, and treatment-by-visit interaction as fixed effects, participant as random effect and baseline as the covariate.||||-2.10|-6.30|0.005
72395618|NCT00137046|144297510|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.069|STANDARD_ERROR_OF_MEAN|0.439||||90.0|-1.792|-0.346|||ANCOVA|||Month 24; Treatment-Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Body Weight, and Center.||-0.346|-1.792|
72395619|NCT00137046|144297510|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.785|STANDARD_ERROR_OF_MEAN|0.418||||90.0|-1.475|-0.096|||ANCOVA|||Follow-up Month 3; Treatment-Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Body Weight, and Center.||-0.096|-1.475|
72471250|NCT02980042|144466280|OTHER||Mean Difference (Net)|-23.22||||0.0061|TWO_SIDED|95.0|-39.66|-6.78||99 patients with non-missing change scores used. Controlled for the false discovery rate (alpha = 0.05) for all cytokines on day 15 using the Benjamini-Hochberg procedure.|t-test, 2 sided|Paired T-test. Degrees of freedom = 98.|Mean of post minus pre. 99 usable change scores.|Paired T-test for change in means. Null hypothesis: no pre-post difference.||-6.78|-39.66|0.0061
72505656|NCT01096667|144542431|SUPERIORITY_OR_OTHER||Difference in least squares means|-1.12||||0.248|TWO_SIDED|80.0|-3.23|0.99||P-value is one-sided.|Mixed Model for Repeated Measures|With terms for treatment, visit, and treatment-by-visit interaction as fixed effects, participant as random effect and baseline as the covariate.||||0.99|-3.23|0.248
72505657|NCT01096667|144542431|SUPERIORITY_OR_OTHER||Difference in least squares means|-3.84||||0.01|TWO_SIDED|80.0|-5.95|-1.73||P-value is one-sided.|Mixed Model for Repeated Measures|With terms for treatment, visit, and treatment-by-visit interaction as fixed effects, participant as random effect and baseline as the covariate.||||-1.73|-5.95|0.010
72505658|NCT01096667|144542431|SUPERIORITY_OR_OTHER||Difference in least squares means|-3.33||||0.02|TWO_SIDED|80.0|-5.4|-1.25||P-value is one-sided.|Mixed Model for Repeated Measures|With terms for treatment, visit, and treatment-by-visit interaction as fixed effects, participant as random effect and baseline as the covariate.||||-1.25|-5.40|0.020
72505659|NCT01096667|144542433|SUPERIORITY_OR_OTHER||Difference in least squares means|42.18||||0|TWO_SIDED|80.0|31.42|52.94||P-value is one-sided. P-value rounded to thousandths.|ANCOVA|Based on ANCOVA with treatment as fixed effect and baseline as a covariate.||||52.94|31.42|0.000
72395620|NCT00137046|144297510|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.445|STANDARD_ERROR_OF_MEAN|0.406||||90.0|-1.114|0.224|||ANCOVA|||Follow-up Month 6; Treatment-Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Body Weight, and Center.||0.224|-1.114|
72471251|NCT02980042|144466281|OTHER||Mean Difference (Net)|-5.69|||<|0.0001|TWO_SIDED|95.0|-7.24|-4.14||99 patients with non-missing change scores used. Controlled for the false discovery rate (alpha = 0.05) for all cytokines on day 15 using the Benjamini-Hochberg procedure.|t-test, 2 sided|Paired T-test. Degrees of freedom = 98.|Mean of post minus pre. 99 usable change scores.|Paired T-test for change in means. Null hypothesis: no pre-post difference.||-4.14|-7.24|<0.0001
72471252|NCT02980042|144466282|OTHER||Mean Difference (Net)|-0.84||||0.0077|TWO_SIDED|95.0|-1.45|-0.23||99 patients with non-missing change scores used. Controlled for the false discovery rate (alpha = 0.05) for all cytokines on day 15 using the Benjamini-Hochberg procedure.|t-test, 2 sided|Paired T-test. Degrees of freedom = 98.|Mean of post minus pre. 99 usable change scores.|Paired T-test for change in means. Null hypothesis: no pre-post difference.||-0.23|-1.45|0.0077
72471253|NCT02980042|144466283|OTHER||Mean Difference (Net)|-0.32|||<|0.0001|TWO_SIDED|95.0|-0.37|-0.27||99 patients with non-missing change scores used. Controlled for the false discovery rate (alpha = 0.05) for all cytokines on day 15 using the Benjamini-Hochberg procedure.|t-test, 2 sided|Paired T-test. Degrees of freedom = 98.|Mean of post minus pre. 99 usable change scores.|Paired T-test for change in means. Null hypothesis: no pre-post difference.||-0.27|-0.37|<0.0001
72471254|NCT00725270|144466284|SUPERIORITY_OR_OTHER|||||||0.812|||||||Mixed Models Analysis|||Repeated Measures ANOVA was run on the Positive Symptom Scale of the Brief Psychiatric Rating Scale, using Baseline and Day 9 ratings. Below is the medication \* time interaction.||||.812
72471255|NCT00725270|144466285|SUPERIORITY_OR_OTHER||eta sq|0.157||||0.203|TWO_SIDED||||||Mixed Models Analysis|||||||.203
72471256|NCT01020877|144466297|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test\[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|110.0|||||TWO_SIDED|90.0|103.0|117.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||117|103|
72471257|NCT01020877|144466298|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|106.0|||||TWO_SIDED|90.0|98.2|115.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||115|98.2|
72505660|NCT01096667|144542433|SUPERIORITY_OR_OTHER||Difference in least squares means|60.39||||0|TWO_SIDED|80.0|49.47|71.31||P-value is one-sided. P-value rounded to thousandths.|ANCOVA|Based on ANCOVA with treatment as fixed effect and baseline as a covariate.||||71.31|49.47|0.000
72505661|NCT01096667|144542433|SUPERIORITY_OR_OTHER||Difference in least squares means|70.34||||0|TWO_SIDED|80.0|59.58|81.1||P-value is one-sided. P-value rounded to thousandths.|ANCOVA|Based on ANCOVA with treatment as fixed effect and baseline as a covariate.||||81.10|59.58|0.000
72505662|NCT01096667|144542433|SUPERIORITY_OR_OTHER||Difference in least squares means|-4.63||||0.713|TWO_SIDED|80.0|-15.22|5.96||P-value is one-sided.|ANCOVA|Based on ANCOVA with treatment as fixed effect and baseline as a covariate.||||5.96|-15.22|0.713
72505663|NCT01096667|144542435|SUPERIORITY_OR_OTHER||Difference in least squares means|-18.1||||0.007|TWO_SIDED|80.0|-27.45|-8.75||P-value is one-sided.|Mixed Model for Repeated Measures|With treatment, visit, and treatment-by-visit interaction as fixed effects, participant as random effect and baseline FPG as the covariate.||||-8.75|-27.45|0.007
72505664|NCT01096667|144542435|SUPERIORITY_OR_OTHER||Difference in least squares means|-34.81||||0|TWO_SIDED|80.0|-44.19|-25.43||P-value is one-sided. P-value rounded to thousandths.|Mixed Model for Repeated Measures|With treatment, visit, and treatment-by-visit interaction as fixed effects, participant as random effect and baseline FPG as the covariate.||||-25.43|-44.19|0.000
72576683|NCT02119819|144680146|SUPERIORITY||Posterior Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.16||0.978|TWO_SIDED|90.0|-0.28|0.24|||Bayesian|||||0.24|-0.28|0.978
72505665|NCT01096667|144542435|SUPERIORITY_OR_OTHER||Difference in least squares means|-35.42||||0|TWO_SIDED|80.0|-44.78|-26.07||P-value is one-sided. P-value rounded to thousandths.|Mixed Model for Repeated Measures|With treatment, visit, and treatment-by-visit interaction as fixed effects, participant as random effect and baseline FPG as the covariate.||||-26.07|-44.78|0.000
72505666|NCT01096667|144542435|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.61||||0.467|TWO_SIDED|80.0|-9.86|8.65||P-value is one-sided.|Mixed Model for Repeated Measures|With treatment, visit, and treatment-by-visit interaction as fixed effects, participant as random effect and baseline FPG as the covariate.||||8.65|-9.86|0.467
72505667|NCT01096667|144542436|SUPERIORITY_OR_OTHER||Difference in least squares means|-5.54||||0.224|TWO_SIDED|80.0|-14.89|3.82||P-value is one-sided.|Mixed Model for Repeated Measures|With treatment, visit, and treatment-by-visit interaction as fixed effects, participant as random effect and baseline FPG as the covariate.||||3.82|-14.89|0.224
72505668|NCT01096667|144542436|SUPERIORITY_OR_OTHER||Difference in least squares means|-17.0||||0.011|TWO_SIDED|80.0|-26.39|-7.61||P-value is one-sided.|Mixed Model for Repeated Measures|With treatment, visit, and treatment-by-visit interaction as fixed effects, participant as random effect and baseline FPG as the covariate.||||-7.61|-26.39|0.011
72505669|NCT01096667|144542436|SUPERIORITY_OR_OTHER||Difference in least squares means|-26.59||||0|TWO_SIDED|80.0|-35.84|-17.33||P-value is one-sided. P-value rounded to thousandths.|Mixed Model for Repeated Measures|With treatment, visit, and treatment-by-visit interaction as fixed effects, participant as random effect and baseline FPG as the covariate.||||-17.33|-35.84|0.000
72505670|NCT01096667|144542436|SUPERIORITY_OR_OTHER||Difference in least squares means|8.65||||0.886|TWO_SIDED|80.0|-0.56|17.87||P-value is one-sided.|Mixed Model for Repeated Measures|With treatment, visit, and treatment-by-visit interaction as fixed effects, participant as random effect and baseline FPG as the covariate.||||17.87|-0.56|0.886
72505671|NCT01751646|144542439|OTHER|||||||0.1166||||||P-value from Wilcoxon rank sum test for change between baseline and Week 48 Vitamin D vs. Placebo|Wilcoxon (Mann-Whitney)|||||||0.1166
72505672|NCT01751646|144542441|OTHER|||||||0.8383|||||||Wilcoxon (Mann-Whitney)|||Test for change between baseline and Week 48 Group A (Vitamin D) vs. Group B (Placebo)||||0.8383
72505673|NCT01751646|144542444|OTHER|||||||0.1378|||||||Wilcoxon (Mann-Whitney)|||Test for change between baseline and Week 48 Group A (Vitamin D) vs. Group B (Placebo)||||0.1378
72622864|NCT01251757|144775928|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.016||||0.022|TWO_SIDED|95.0|0.002|0.029|||Regression, Linear|Adjusted for site, gender, age, total number of prescription medications participant was taking, comorbid diabetes/CVD, baseline ACEI/ARB adherence.|Adjusted difference in adherence for IVR+ group versus UC group, calculated as IVR+ - UC.|We conducted separate primary analyses of each of IVR and IVR+ versus usual care at the .025 level of significance to assure a trial-wide error rate of .05. This analysis summary is for the IVR versus UC comparison only. Also, we only report results here for the full sample, and not also separately for the 3 baseline adherence level groups.||0.029|0.002|0.022
72622865|NCT01251757|144775928|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.037|||<|0.001|TWO_SIDED|95.0|0.023|0.05|||Regression, Linear|Adjusted for site, gender, age, total number of prescription medications participant was taking, comorbid diabetes/CVD, baseline ACEI/ARB adherence.|Adjusted difference in adherence for IVR+ group versus UC group, calculated as IVR+ - UC.|We conducted separate primary analyses of each of IVR and IVR+ versus usual care at the .025 level of significance to assure a trial-wide error rate of .05. This analysis summary is for the IVR+ versus UC comparison only. Also, we only report results here for the full sample, and not also separately for the 3 baseline adherence level groups.||0.050|0.023|<.001
72395621|NCT00137046|144297510|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.054|STANDARD_ERROR_OF_MEAN|0.654||||90.0|-1.133|1.025|||ANCOVA|||Extension Month 1; Treatment-Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Body Weight, and Center.||1.025|-1.133|
72505674|NCT01751646|144542446|OTHER|||||||0.4686|||||||Wilcoxon (Mann-Whitney)|||Test for change between baseline and Week 48 Group A (Vitamin D) vs. Group B (Placebo)||||0.4686
72505675|NCT01751646|144542448|OTHER|||||||0.7601|||||||Wilcoxon (Mann-Whitney)|||Test for change between baseline and Week 48 Group A (Vitamin D) vs. Group B (Placebo)||||0.7601
72505676|NCT01751646|144542450|OTHER|||||||0.3978|||||||Wilcoxon (Mann-Whitney)|||Test for change between baseline and Week 48 Group A (Vitamin D) vs. Group B (Placebo)||||0.3978
72505677|NCT01751646|144542452|OTHER|||||||0.1187|||||||Wilcoxon (Mann-Whitney)|||Test for change between baseline and Week 48 Group A (Vitamin D) vs. Group B (Placebo)||||0.1187
72505678|NCT01751646|144542455|OTHER|||||||0.5098|||||||Wilcoxon (Mann-Whitney)|||Test for change between baseline and Week 48 Group A (Vitamin D) vs. Group B (Placebo)||||0.5098
72505679|NCT01751646|144542456|OTHER|||||||0.255|||||||Wilcoxon (Mann-Whitney)|||Test for change between baseline and Week 48 Group A (Vitamin D) vs. Group B (Placebo)||||0.2550
72505680|NCT01751646|144542457|OTHER|||||||0.6499|||||||Wilcoxon (Mann-Whitney)|||Test for change between baseline and Week 48 Group A (Vitamin D) vs. Group B (Placebo)||||0.6499
72505681|NCT01751646|144542458|OTHER|||||||0.2348|||||||Wilcoxon (Mann-Whitney)|||Test for change between baseline and Week 48 Group A (Vitamin D) vs. Group B (Placebo)||||0.2348
72505682|NCT01751646|144542461|OTHER|||||||0.2648|||||||Wilcoxon (Mann-Whitney)|||Test for change between baseline and Week 48 Group A (Vitamin D3) vs. Group B (Placebo)||||0.2648
72505683|NCT01751646|144542464|OTHER|||||||0.3728|||||||Wilcoxon (Mann-Whitney)|||Test for change between baseline and Week 48 Group A (Vitamin D3) vs. Group B (Placebo)||||0.3728
72505684|NCT01751646|144542467|OTHER|||||||0.7825|||||||Wilcoxon (Mann-Whitney)|||Test for change between baseline and Week 48 Group A (Vitamin D3) vs. Group B (Placebo)||||0.7825
72505685|NCT01751646|144542470|OTHER|||||||0.195|||||||Wilcoxon (Mann-Whitney)|||Test for change between baseline and Week 48 Group A (Vitamin D3) vs. Group B (Placebo)||||0.1950
72505686|NCT01751646|144542473|OTHER|||||||0.7127|||||||Wilcoxon (Mann-Whitney)|||Test for change between baseline and Week 48 Group A (Vitamin D3) vs. Group B (Placebo)||||0.7127
72505687|NCT01751646|144542476|OTHER|||||||0.4676|||||||Wilcoxon (Mann-Whitney)|||Test for change between baseline and Week 48 Group A (Vitamin D3) vs. Group B (Placebo)||||0.4676
72505688|NCT01751646|144542479|OTHER|||||||0.021|||||||Wilcoxon (Mann-Whitney)|||Test for change between baseline and Week 48 Group A (Vitamin D3) vs. Group B (Placebo)||||0.0210
72505689|NCT01751646|144542482|OTHER|||||||0.0144|||||||Wilcoxon (Mann-Whitney)|||Test for change between baseline and Week 48 Group A (Vitamin D3) vs. Group B (Placebo)||||0.0144
72622866|NCT01251757|144775929|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.14||||0.002|TWO_SIDED|95.0|1.05|1.24||Adjusted for site, gender, age, total number of prescription medications patient is taking, comorbid diabetes/CVD, and baseline statin adherence.|Regression, Logistic||Adjusted odds ratio for good adherence in IVR group versus UC group, calculated as IVR - UC.|We conducted separate primary analyses of each of IVR and IVR+ versus usual care at the .025 level of significance to assure a trial-wide error rate of .05. This analysis summary is for the IVR versus UC comparison only. Also, we only report results here for the full sample, and not also separately for the 3 baseline adherence level groups.||1.24|1.05|0.002
72395622|NCT00137046|144297510|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.336|STANDARD_ERROR_OF_MEAN|0.668||||90.0|-2.438|-0.235|||ANCOVA|||Extension Month 3; Treatment-Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Body Weight, and Center.||-0.235|-2.438|
72395623|NCT00137046|144297510|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.462|STANDARD_ERROR_OF_MEAN|0.542||||90.0|-2.356|-0.568|||ANCOVA|||Extension Month 6; Treatment-Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Body Weight, and Center.||-0.568|-2.356|
72395624|NCT00137046|144297510|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.385|STANDARD_ERROR_OF_MEAN|0.564||||90.0|-2.316|-0.454|||ANCOVA|||Extension Month 9; Treatment-Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Body Weight, and Center.||-0.454|-2.316|
72395625|NCT00137046|144297510|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.955|STANDARD_ERROR_OF_MEAN|0.559||||90.0|-1.877|-0.034|||ANCOVA|||Extension Month 12; Treatment-Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Body Weight, and Center.||-0.034|-1.877|
72395626|NCT00137046|144297510|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0|STANDARD_ERROR_OF_MEAN|0.588||||90.0|-1.97|-0.03|||ANCOVA|||Extension Month 15; Treatment-Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Body Weight, and Center.||-0.030|-1.970|
72505690|NCT01751646|144542485|OTHER||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||Test for change between baseline and Week 48 Group A (Vitamin D3) vs. Group B (Placebo)||||< 0.0001
72505691|NCT01751646|144542488|OTHER|||||||0.0814|||||||Wilcoxon (Mann-Whitney)|||Test for change between baseline and Week 48 Group A (Vitamin D3) vs. Group B (Placebo)||||0.0814
72505692|NCT01751646|144542491|OTHER|||||||0.4808|||||||Wilcoxon (Mann-Whitney)|||Test for change between baseline and Week 48 Group A (Vitamin D3) vs. Group B (Placebo)||||0.4808
72505693|NCT01751646|144542494|OTHER|||||||0.387|||||||Wilcoxon (Mann-Whitney)|||Test for change between baseline and Week 48 Group A (Vitamin D3) vs. Group B (Placebo)||||0.3870
72505694|NCT01751646|144542497|OTHER|||||||0.429|||||||Wilcoxon (Mann-Whitney)|||Test for change between baseline and Week 48 Group A (Vitamin D) vs. Group B (Placebo)||||0.4290
72505695|NCT01751646|144542498|OTHER|||||||0.9186|||||||Wilcoxon (Mann-Whitney)|||Test for change between baseline and Week 48 Group A (Vitamin D3) vs. Group B (Placebo)||||0.9186
72505696|NCT01751646|144542499|OTHER|||||||0.4016|||||||Wilcoxon (Mann-Whitney)|||Test for change between baseline and Week 48 Group A (Vitamin D3) vs. Group B (Placebo)||||0.4016
72505697|NCT01751646|144542500|OTHER|||||||0.581|||||||Wilcoxon (Mann-Whitney)|||Test for change between baseline and Week 48 Group A (Vitamin D3) vs. Group B (Placebo)||||0.5810
72505698|NCT01751646|144542501|OTHER|||||||0.157|||||||Wilcoxon (Mann-Whitney)|||Test for change between baseline and Week 48 Group A (Vitamin D3) vs. Group B (Placebo)||||0.1570
72505699|NCT01751646|144542507|OTHER||||||<|0.0001|||||||Wilcoxon Signed Rank Test|||Test of change from baseline to week 48||||<0.0001
72395627|NCT00137046|144297510|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.96|STANDARD_ERROR_OF_MEAN|0.655||||90.0|-2.041|0.121|||ANCOVA|||Extension Month 18; Treatment-Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Body Weight, and Center.||0.121|-2.041|
72395628|NCT00137046|144297510|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.667|STANDARD_ERROR_OF_MEAN|0.668||||90.0|-2.77|-0.565|||ANCOVA|||Extension Month 21; Treatment-Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Body Weight, and Center.||-0.565|-2.770|
72395629|NCT00137046|144297510|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.872|STANDARD_ERROR_OF_MEAN|0.692||||90.0|-3.013|-0.73|||ANCOVA|||Extension Month 24; Treatment-Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Body Weight, and Center.||-0.730|-3.013|
72505700|NCT01751646|144542507|OTHER||||||<|0.0001|||||||Wilcoxon Signed Rank Test|||Test of change from baseline to Week 48||||<0.0001
72505701|NCT01751646|144542510|OTHER||||||<|0.0001|||||||Wilcoxon Signed Rank Test|||Test of Week 48 difference from baseline||||< 0.0001
72505702|NCT01751646|144542510|OTHER||||||<|0.0001|||||||Wilcoxon Signed Rank Test|||Test of Week 48 difference from baseline||||< 0.0001
72505703|NCT02613572|144542515|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.00
72505704|NCT02613572|144542516|SUPERIORITY|||||||0.009|||||||Mixed Models Analysis|||||||0.009
72505705|NCT02613572|144542517|SUPERIORITY|||||||0.09|||||||Mixed Models Analysis|||||||0.09
72505706|NCT02613572|144542518|SUPERIORITY|||||||0.3|||||||Mixed Models Analysis|||||||0.30
72505707|NCT02613572|144542519|SUPERIORITY|||||||0.14|||||||Mixed Models Analysis|||||||0.14
72505708|NCT02613572|144542520|SUPERIORITY|||||||0.69|||||||Mixed Models Analysis|||||||0.69
72505709|NCT01748695|144542536|SUPERIORITY_OR_OTHER|||||||0.834||||||Based on a linear mixed measures model with treatment and period included as fixed effects, subject included as a random effect and between- and within- subject baseline covariates included.|Regression, Linear|||||||0.834
72505710|NCT00465738|144542542|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% Newcombe-Wilson confidence interval for the difference between the response rates of the groups was calculated. The lower bound of the Newcombe-Wilson CI for the difference of proportions was compared to the non-inferiority margin of -25%.|difference in response rates|10.6|||||TWO_SIDED|95.0|-4.4|24.9|||||difference in response rates = response rate for high volume dilution group (20 U/ml) - response rate for low volume dilution group (50 U/ml)|Null hypothesis: The response rate for the low volume dilution group (50 U/ml) is greater than the response rate for the high volume dilution group (20 U/ml).||24.9|-4.4|
72395630|NCT00137046|144297510|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.887|STANDARD_ERROR_OF_MEAN|0.725||||90.0|-3.084|-0.69|||ANCOVA|||Extension Month 27; Treatment-Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Body Weight, and Center.||-0.690|-3.084|
72395631|NCT00137046|144297510|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.794|STANDARD_ERROR_OF_MEAN|0.891||||90.0|-4.264|-1.324|||ANCOVA|||Extension Month 30; Treatment-Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Body Weight, and Center.||-1.324|-4.264|
72505711|NCT03425656|144542604|NON_INFERIORITY|We used a non-inferiority margin of 0.25 for the primary endpoint.|Mean Difference (Net)|-0.03||||0.73|TWO_SIDED|95.0|-0.23|0.16|||Chi-squared|||||0.16|-0.23|0.73
72505712|NCT03425656|144542605|OTHER|||||||0.72|||||||Fisher Exact|||||||0.72
72505713|NCT03425656|144542606|OTHER||Chi-squared|0.42||||0.42|TWO_SIDED||||||Chi-squared|||||||0.42
72505714|NCT03425656|144542607|NON_INFERIORITY|We used a non-inferiority margin of 0.25 for the primary endpoint.||||||0.59|||||||Chi-squared|||||||0.59
72395632|NCT00137046|144297510|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.287|STANDARD_ERROR_OF_MEAN|1.091||||90.0|-5.088|-1.485|||ANCOVA|||Extension Month 33; Treatment-Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Body Weight, and Center.||-1.485|-5.088|
72505715|NCT01507246|144542612|SUPERIORITY_OR_OTHER||Ratio of geometric means|2.62||||0.0251|TWO_SIDED|95.0|1.14|6.03|||least-squares mean ratio||Group 1 represents the numerator.|Null hypothesis: Mean ratio of geometric least-squares mean for each group is identical.||6.03|1.14|0.0251
72505716|NCT01507246|144542613|SUPERIORITY_OR_OTHER||Ratio of geometric means|1.24||||0.02767|TWO_SIDED|95.0|1.03|1.49|||least-squares mean ratio||Group 1 represents the numerator.|Null hypothesis = distribution of costs is identical between the two groups.||1.49|1.03|0.02767
72505717|NCT01438710|144542635|SUPERIORITY_OR_OTHER|||||||0.0048|TWO_SIDED|95.0|||||t-test, 2 sided|||The mean change (i.e., absolute change) from baseline (Day 7, pre-conversion) on FTM overall score to Day 14 (post-conversion) was evaluated using paired t-test (at 0.05 significance level, two sided). An estimation of mean change from baseline and the corresponding 95% confidence interval (CI) were provided.||||0.0048
72505718|NCT04192448|144542640|OTHER|Target sample size was 200 participants. Power calculation was determined using nQuery version 8.4.1 for the 2x2 design, using 50 subject per group (including a conservative 10% dropout). Power calculation estimated 80% power to detect an effect size of 0.3 in both factors with no interaction, and greater power if there is an interaction effect. Current enrollment indicates study is underpowered. Because there are not enough participants to conduct an ANOVA or ANCOVA, t-tests were conducted.|Mean Difference (Final Values)|1.82||||0.28|TWO_SIDED|95.0|-29.82|26.19|||t-test, 1 sided|This t-test examined the difference in sexual aggression intentions between those in the Alcohol condition and those in the Sober condition.|The estimation parameter refers to the mean difference in the outcome between those in the Alcohol condition and those in the Sober condition. A positive value indicates greater likelihood of sexual aggression among those in the Alcohol condition.|The number of participants enrolled in the study constrained the type of statistical analyses able to be conducted. Indeed, the Sober x Anger condition could not be compared to the other arms because no participants were randomly assigned to that arm.||26.19|-29.82|.28
72505719|NCT04192448|144542640|OTHER|Target sample size was 200 participants. Power calculation was determined using nQuery version 8.4.1 for the 2x2 design, using 50 subject per group (including a conservative 10% dropout). Power calculation estimated 80% power to detect an effect size of 0.3 in both factors with no interaction, and greater power if there is an interaction effect. Current enrollment indicates study is underpowered. Because there are not enough participants to conduct an ANOVA or ANCOVA, t-tests were conducted.|Mean Difference (Final Values)|-1.0||||0.39|TWO_SIDED|95.0|-33.01|35.01|||t-test, 1 sided|This t-test examined the difference in sexual aggression intentions between those in the Anger condition and those in the Control condition.|The estimation parameter refers to the mean difference in the outcome between those in the Anger condition and those in the Control condition. A negative value indicates greater likelihood of sexual aggression among those in the Control condition.|The number of participants enrolled in the study constrained the type of statistical analyses able to be conducted. Indeed, the Sober x Anger condition could not be compared to the other arms because no participants were randomly assigned to that arm.||35.01|-33.01|.39
72505720|NCT04192448|144542641|OTHER|Target sample size was 200 participants. Power calculation was determined using nQuery version 8.4.1 for the 2x2 design, using 50 subject per group (including a conservative 10% dropout). Power calculation estimated 80% power to detect an effect size of 0.3 in both factors with no interaction, and greater power if there is an interaction effect. Current enrollment indicates study is underpowered. Because there are not enough participants to conduct an ANOVA or ANCOVA, t-tests were conducted.|Mean Difference (Final Values)|0.25||||0.33|TWO_SIDED|95.0|-2.88|2.63|||t-test, 1 sided|This t-test examined the difference in physical aggression intentions between those in the Alcohol Condition and those in the Sober condition.|The estimation parameter refers to the mean difference in the outcome between those in the Alcohol condition and those in the Sober condition. A positive value indicates greater likelihood of physical aggression among those in the Alcohol condition.|The number of participants enrolled in the study constrained the type of statistical analyses able to be conducted. Indeed, the Sober x Anger condition could not be compared to the other arms because no participants were randomly assigned to that arm.||2.63|-2.88|.33
72542440|NCT01455545|144614660|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.556||||0.155|TWO_SIDED|95.0|0.247|1.253|||Chi-squared|||Ho = no differences between both groups H1= there are differences between both groups. Cross tabs Chi squared test.||1.253|0.247|0.155
72542441|NCT01455545|144614661|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.19||||0.107|TWO_SIDED|95.0|0.02|1.763|||Chi-squared|||Ho = no differences between both groups H1= there are differences between both groups. Cross tabs Chi squared test.||1.763|0.020|0.107
72542442|NCT01455545|144614662|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.849||||0.196|TWO_SIDED|95.0|1.541|2.219|||Chi-squared|||Ho = no differences between both groups H1= there are differences between both groups. Cross tabs Chi squared test.||2.219|1.541|0.196
72395633|NCT00137046|144297510|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.486|STANDARD_ERROR_OF_MEAN|0.857||||90.0|-2.901|-0.071|||ANCOVA|||Extension Month 36; Treatment-Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Body Weight, and Center.||-0.071|-2.901|
72395634|NCT00137046|144297510|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.131|STANDARD_ERROR_OF_MEAN|1.356||||90.0|-5.382|-0.88|||ANCOVA|||Extension Month 39; Treatment-Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Body Weight, and Center.||-0.880|-5.382|
72565614|NCT02709486|144662686|SUPERIORITY||Least Square Mean Difference|-0.67|STANDARD_ERROR_OF_MEAN|0.17|<|0.0001|TWO_SIDED|95.0|-1.0|-0.34|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariates, and study site as a random effect.||-0.34|-1.00|<.0001
72565615|NCT02709486|144662686|SUPERIORITY||Least Square Mean Difference|-0.68|STANDARD_ERROR_OF_MEAN|0.17|<|0.0001|TWO_SIDED|95.0|-1.0|-0.35|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariates, and study site as a random effect.||-0.35|-1.00|<.0001
72565616|NCT02709486|144662688|SUPERIORITY||Least Square Mean Difference|-0.23|STANDARD_ERROR_OF_MEAN|0.05|<|0.0001|TWO_SIDED|95.0|-0.33|-0.12|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline PGA of osteoarthritis and baseline diary average pain as covariates, and study site as a random effect.||-0.12|-0.33|<.0001
72565617|NCT02709486|144662688|SUPERIORITY||Least Square Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.05||0.0022|TWO_SIDED|95.0|-0.27|-0.06|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline PGA of osteoarthritis and baseline diary average pain as covariates, and study site as a random effect.||-0.06|-0.27|0.0022
72565618|NCT02709486|144662688|SUPERIORITY||Least Square Mean Difference|-0.24|STANDARD_ERROR_OF_MEAN|0.05|<|0.0001|TWO_SIDED|95.0|-0.35|-0.14|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline PGA of osteoarthritis and baseline diary average pain as covariates, and study site as a random effect.||-0.14|-0.35|<.0001
72565619|NCT02709486|144662688|SUPERIORITY||Least Square Mean Difference|-0.32|STANDARD_ERROR_OF_MEAN|0.05|<|0.0001|TWO_SIDED|95.0|-0.43|-0.22|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline PGA of osteoarthritis and baseline diary average pain as covariates, and study site as a random effect.||-0.22|-0.43|<.0001
72565620|NCT02709486|144662688|SUPERIORITY||Least Square Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.06||0.0029|TWO_SIDED|95.0|-0.28|-0.06|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline PGA of osteoarthritis and baseline diary average pain as covariates, and study site as a random effect.||-0.06|-0.28|0.0029
72565621|NCT02709486|144662688|SUPERIORITY||Least Square Mean Difference|-0.26|STANDARD_ERROR_OF_MEAN|0.06|<|0.0001|TWO_SIDED|95.0|-0.37|-0.15|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline PGA of osteoarthritis and baseline diary average pain as covariates, and study site as a random effect.||-0.15|-0.37|<.0001
72565622|NCT02709486|144662688|SUPERIORITY||Least Square Mean Difference|-0.29|STANDARD_ERROR_OF_MEAN|0.06|<|0.0001|TWO_SIDED|95.0|-0.4|-0.17|||ANCOVA|||Week 12: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline PGA of osteoarthritis and baseline diary average pain as covariates, and study site as a random effect.||-0.17|-0.40|<.0001
72576684|NCT02119819|144680146|SUPERIORITY||Posterior Mean Difference|0.09|STANDARD_ERROR_OF_MEAN|0.16||0.904|TWO_SIDED|90.0|-0.17|0.35|||Bayesian|||||0.35|-0.17|0.904
72576685|NCT01549405|144680188|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||Mann-Whitney U test|||||||0.002
72576686|NCT01549405|144680189|SUPERIORITY_OR_OTHER||Mean Difference (Net)|122.1|STANDARD_DEVIATION|58.0||0|TWO_SIDED|95.0|52.98|132.4|||t-test, 2 sided|||||132.4|52.98|0.000
72395635|NCT00137046|144297510|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.487|STANDARD_ERROR_OF_MEAN|0.866||||90.0|-2.918|-0.055|||ANCOVA|||Extension Follow Up Month 3; Treatment-Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Body Weight, and Center.||-0.055|-2.918|
72576687|NCT01191944|144680190|NON_INFERIORITY_OR_EQUIVALENCE|pre-specified non-inferiority (NI) margin of -4 points|Mean Difference (Final Values)|0.76|STANDARD_ERROR_OF_MEAN|0.9192|<|0.0001||95.0|-1.047|2.566||one-sided test relative to NI margin of -4|ANCOVA|adjusted for treatment, centre and baseline|Pramipexole IR minus Pramipexole ER, Pramipexole ER non inferior to Pramipexole IR if lower limit of confidence interval (CI) for the mean difference is higher than NI margin.|The null hypothesis (H0) states that the mean change from baseline to Week 18 (or last observation carried forward \[LOCF\]) in the UPDRS II+III score for the treatment group pramipexole ER is inferior to the mean change for the treatment group pramipexole IR.||2.566|-1.047|<0.0001
72576688|NCT01191944|144680191|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.48|STANDARD_ERROR_OF_MEAN|2.1836||0.8261|TWO_SIDED|95.0|-4.787|3.826|||ANCOVA|||||3.826|-4.787|0.8261
72576689|NCT01191944|144680192|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.054|STANDARD_ERROR_OF_MEAN|0.3274||0.8698|TWO_SIDED|95.0|-0.699|0.592|||ANCOVA|||||0.592|-0.699|0.8698
72576690|NCT01191944|144680193|SUPERIORITY_OR_OTHER|||||||0.7902||95.0|||||Cochran-Mantel-Haenszel|||||||0.7902
72576691|NCT01191944|144680194|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-2.763|STANDARD_ERROR_OF_MEAN|2.7845||0.3223|TWO_SIDED|95.0|-8.255|2.729|||ANCOVA|||||2.729|-8.255|0.3223
72471258|NCT01020877|144466299|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|106.0|||||TWO_SIDED|90.0|97.6|115.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||115|97.6|
72471259|NCT01483144|144466303|SUPERIORITY||Hazard Ratio (HR)|0.71||||0.121|TWO_SIDED|95.0|0.4|1.3||The threshold for statistical significance is p=0.05|stratified Cox proportional (Score)||Eflornithine plus sulindac is the numerator and sulindac plus eflornithine placebo is the denominator.|Intent to treat population with all FAP-related events||1.3|0.4|0.1210
72471260|NCT01483144|144466303|SUPERIORITY||Hazard Ratio (HR)|0.66||||0.1076|TWO_SIDED|95.0|0.4|1.2||The threshold for statistical significance is p=0.05|stratified Cox proportional (Score)||Eflornithine plus sulindac is the numerator and eflornithine plus sulindac placebo is the denominator.|Intent to treat population with all FAP-related events||1.2|0.4|0.1076
72471261|NCT01483144|144466303|SUPERIORITY||Hazard Ratio (HR)|0.2||||0.0201|TWO_SIDED|95.0|0.0|0.8||Threshold for statistical significance was p=0.05|stratified Cox proportional (Score)||Eflornithine and sulindac is the numerator and sulindac and eflornithine placebo is the denominator. Reduction in relative risk for FAP-related events with the combination.|Lower GI population||0.8|0.0|0.0201
72471262|NCT01483144|144466303|SUPERIORITY||Hazard Ratio (HR)|0.17||||0.0101|TWO_SIDED|95.0|0.0|0.7||Threshold of significance was p=0.05|stratified Cox proportional (Score)||Eflornithine and sulindac is the numerator and eflornithine and sulindac placebo is the denominator.|Lower GI population||0.7|0|0.0101
72471263|NCT01483144|144466304|SUPERIORITY|||||||0.8127||||||The threshold of significance was p=0.05|Mantel Haenszel|||||||0.8127
72622867|NCT01251757|144775929|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.16|||<|0.001|TWO_SIDED|95.0|1.06|1.26||Adjusted for site, gender, age, total number of prescription medications patient is taking, comorbid diabetes/CVD, and baseline statin adherence.|Regression, Logistic||Adjusted odds ratio for good adherence in IVR+ group versus UC group, calculated as IVR+ - UC.|We conducted separate primary analyses of each of IVR and IVR+ versus usual care at the .025 level of significance to assure a trial-wide error rate of .05. This analysis summary is for the IVR+ versus UC comparison only. Also, we only report results here for the full sample, and not also separately for the 3 baseline adherence level groups.||1.26|1.06|<0.001
72471264|NCT01483144|144466304|SUPERIORITY|||||||0.8133||||||The threshold for significance was p=0.05|Mantel Haenszel|||||||0.8133
72471265|NCT01483144|144466305|SUPERIORITY|||||||0.999||||||The threshold for significance was p=0.05|Mantel Haenszel|||||||0.999
72471266|NCT01483144|144466305|SUPERIORITY|||||||0.2152||||||The threshold for significance was p=0.05|Mantel Haenszel|||||||0.2152
72471267|NCT03322540|144466322|SUPERIORITY||Difference in Percentages|-6.5||||0.8|TWO_SIDED|95.0|-21.5|8.7|||Stratified Miettinen and Nurminen method|One-sided p-value for testing. H0: difference in % = 0 versus H1: difference in % \> 0.|Point estimate was assessed based on Miettinen \& Nurminen method stratified by predominant tumor histology (squamous vs non-squamous).|||8.7|-21.5|0.8000
72471268|NCT04052425|144466328|SUPERIORITY||Odds Ratio (OR)|5.28|||<|0.0001|TWO_SIDED|95.0|2.341|11.903||The model included the treatment group (1.5% BID and vehicle) and stratification factors (skin type and region).|exact logistic regression|||||11.903|2.341|< 0.0001
72471269|NCT04052425|144466329|SUPERIORITY||Odds Ratio (OR)|5.18|||<|0.0001|TWO_SIDED|95.0|2.831|9.482||The model included the treatment group (1.5% BID and vehicle) and stratification factors (skin type and region).|exact logistic regression|||||9.482|2.831|< 0.0001
72471270|NCT04052425|144466330|SUPERIORITY||Odds Ratio (OR)|8.49||||0.0038|TWO_SIDED|95.0|1.997|36.048||The model included the treatment group (1.5% BID and vehicle) and stratification factors (skin type and region).|exact logistic regression|||||36.048|1.997|0.0038
72471271|NCT04052425|144466331|SUPERIORITY||Odds Ratio (OR)|4.93||||0.002|TWO_SIDED|95.0|1.795|13.566||The model included the treatment group (1.5% BID and vehicle) and stratification factors (skin type and region).|exact logistic regression|||||13.566|1.795|0.0020
72471272|NCT04052425|144466332|SUPERIORITY||Odds Ratio (OR)|9.53||||0.0002|TWO_SIDED|95.0|2.9|31.29||The model included the treatment group (1.5% BID and vehicle) and stratification factors (skin type and region).|exact logistic regression|||||31.290|2.900|0.0002
72471273|NCT04052425|144466333|SUPERIORITY||least squares mean difference|-19.3|STANDARD_ERROR_OF_MEAN|3.93|<|0.0001|TWO_SIDED|95.0|-27.05|-11.64||Response Variable = Treatment + Stratification Factors (Skin Type Fitzpatrick scale Type I, II versus Type III, IV, V, and VI, Region North America/Europe) + Baseline|ANCOVA|||||-11.64|-27.05|< 0.0001
72471274|NCT04052425|144466336|SUPERIORITY||Odds Ratio (OR)|5.56|||<|0.0001|TWO_SIDED|95.0|3.226|9.578||The model included the treatment group (1.5% BID and vehicle) and stratification factors (skin type and region).|exact logistic regression|||||9.578|3.226|< 0.0001
72471275|NCT04052425|144466338|SUPERIORITY||least squares mean difference|-30.61|STANDARD_ERROR_OF_MEAN|4.28|<|0.0001|TWO_SIDED|95.0|-39.03|-22.19|||mixed-effect model; repeated measurement|||||-22.19|-39.03|<0.0001
72471276|NCT04052425|144466341|SUPERIORITY||least squares mean difference|-16.98|STANDARD_ERROR_OF_MEAN|3.2|<|0.0001|TWO_SIDED|95.0|-23.28|-10.68|||mixed-effect model; repeated measurement|||||-10.68|-23.28|<0.0001
72471277|NCT04052425|144466343|SUPERIORITY||least squares mean difference|-9.07|STANDARD_ERROR_OF_MEAN|2.49||0.0003|TWO_SIDED|95.0|-13.96|-4.18|||mixed-effect model; repeated measurement|||||-4.18|-13.96|0.0003
72471278|NCT04052425|144466345|SUPERIORITY||Odds Ratio (OR)|3.04|||<|0.0001|TWO_SIDED|95.0|1.746|5.307||The model included the treatment group (1.5% BID and vehicle) and stratification factors (skin type and region).|exact logistic regression|||T-VASI25||5.307|1.746|< 0.0001
72471279|NCT04052425|144466345|SUPERIORITY||Odds Ratio (OR)|2.3||||0.2921|TWO_SIDED|95.0|0.489|10.823||The model included the treatment group (1.5% BID and vehicle) and stratification factors (skin type and region).|exact logistic regression|||T-VASI75||10.823|0.489|0.2921
72471280|NCT04052425|144466345|SUPERIORITY||Odds Ratio (OR)|0.49||||||||||The p value was not evaluable because the response rate in the vehicle group was too low.||||T-VASI90||||
72505721|NCT04192448|144542641|OTHER|Target sample size was 200 participants. Power calculation was determined using nQuery version 8.4.1 for the 2x2 design, using 50 subject per group (including a conservative 10% dropout). Power calculation estimated 80% power to detect an effect size of 0.3 in both factors with no interaction, and greater power if there is an interaction effect. Current enrollment indicates study is underpowered. Because there are not enough participants to conduct an ANOVA or ANCOVA, t-tests were conducted.|Mean Difference (Final Values)|-0.25||||0.33|TWO_SIDED|95.0|-2.53|2.88|||t-test, 1 sided|The t-test examined the difference in physical aggression intentions between those in the Anger condition and those in the Control condition.|The estimation parameter refers to the mean difference in the outcome between those in the Anger condition and those in the Control condition. A negative value indicates greater likelihood of physical aggression among those in the Control condition.|The number of participants enrolled in the study constrained the type of statistical analyses able to be conducted. Indeed, the Sober x Anger condition could not be compared to the other arms because no participants were randomly assigned to that arm.||2.88|-2.53|.33
72505722|NCT04192448|144542642|OTHER|Target sample size was 200 participants. Power calculation was determined using nQuery version 8.4.1 for the 2x2 design, using 50 subject per group (including a conservative 10% dropout). Power calculation estimated 80% power to detect an effect size of 0.3 in both factors with no interaction, and greater power if there is an interaction effect. Current enrollment indicates study is underpowered. Because there are not enough participants to conduct an ANOVA or ANCOVA, t-tests were conducted.|Mean Difference (Final Values)|0.67||||0.23|TWO_SIDED|95.0|-8.0|6.67|||t-test, 1 sided|The t-test examined differences in psychological aggression intentions between those in the Alcohol condition and those in the Sober condition.|The estimation parameter refers to the mean difference in the outcome between those in the Alcohol condition and those in the Sober condition. A positive value indicates greater likelihood of psych aggression among those in the Alcohol condition.|The number of participants enrolled in the study constrained the type of statistical analyses able to be conducted. Indeed, the Sober x Anger condition could not be compared to the other arms because no participants were randomly assigned to that arm.||6.67|-8.00|.23
72505723|NCT04192448|144542642|OTHER|Target sample size was 200 participants. Power calculation was determined using nQuery version 8.4.1 for the 2x2 design, using 50 subject per group (including a conservative 10% dropout). Power calculation estimated 80% power to detect an effect size of 0.3 in both factors with no interaction, and greater power if there is an interaction effect. Current enrollment indicates study is underpowered. Because there are not enough participants to conduct an ANOVA or ANCOVA, t-tests were conducted.|Mean Difference (Final Values)|-0.17||||0.44|TWO_SIDED|95.0|-10.84|11.17|||t-test, 1 sided|The t-test examined the difference in psychological aggression intentions between those in the Anger condition and those in the Control condition.|The estimation parameter refers to the mean difference in the outcome between those in the Alcohol condition and those in the Sober condition. A negative value indicates greater likelihood of psych aggression among those in the Control condition.|The number of participants enrolled in the study constrained the type of statistical analyses able to be conducted. Indeed, the Sober x Anger condition could not be compared to the other arms because no participants were randomly assigned to that arm.||11.17|-10.84|.44
72505724|NCT00128206|144542649|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.51|||>|0.05||95.0|0.13|2.01|||Chi-squared|||The null hypothesis was that there would be no difference in toxicity by study group, and a sample of 360 participants (180 in each group)was estimated to have sufficient power to detect a difference.||2.01|.13|>.05
72505725|NCT01040832|144542652|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.1||||0.793|TWO_SIDED|95.0|0.7|1.6|||Stratified log rank|||||1.6|0.7|0.793
72505726|NCT01040832|144542653|SUPERIORITY_OR_OTHER||||||>|0.999||95.0|||||Cochran-Mantel-Haenszel|||||||>0.999
72505727|NCT01040832|144542654|SUPERIORITY_OR_OTHER|||||||0.557||95.0|||||Cochran-Mantel-Haenszel|||||||0.557
72505728|NCT02940886|144542657|NON_INFERIORITY|Non-inferiority could be claimed if the lower bound of the 95% confidence interval (CI) was above -0.5 g/dL.|Mean Difference (Final Values)|0.0|||||TWO_SIDED|95.0|-0.13|0.13|||||Mixed Model for Repeated Measurement was used for testing and included the fixed categorical effects of treatment, week, treatment-by-week interaction, strata, and the continuous covariates of baseline Hb and baseline Hb-by-week interaction.|"Power:~With N=1000 subjects in the iron isomaltoside/ferric derisomaltose treatment group and with N=500 subjects in the iron sucrose treatment group, assuming no difference between the treatment groups and assuming a common standard deviation (SD) of 1.5 g/dL, the power was 100% for demonstrating non-inferiority of the change in Hb from baseline to week 8, using a non-inferiority margin of -0.5 g/dL.~The significance level was set to 5%."||0.13|-0.13|
72505729|NCT02940886|144542658|OTHER||95% two-sided CI (iron isomaltoside)|0.3|||||TWO_SIDED|95.0|0.06|0.88||||||"Power:~With N=1000 subjects in the iron isomaltoside/ferric derisomaltose, the power was 88% to demonstrate that the upper bound of the 95% CI of the incidence of treatment-emergent serious and/or severe non-serious hypersensitivity AEs was less than 3%.~The significance level was set to 5%."||0.88|0.06|
72395636|NCT00137046|144297519|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.744|STANDARD_ERROR_OF_MEAN|0.144||||90.0|-0.981|-0.506|||ANCOVA|||Month 3; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||-0.506|-0.981|
72505730|NCT02940886|144542658|OTHER||Risk Difference (RD)|-0.1|||||TWO_SIDED|95.0|-0.91|0.71||||||Risk difference between iron isomaltoside/ferric derisomaltose and iron sucrose was assessed for the individual trial with 95% Newcombe CI adjusted for stratum using the Cochran-Mantel-Haenszel method.||0.71|-0.91|
72505731|NCT02940886|144542658|NON_INFERIORITY|Non-inferiority can be claimed if the upper bound of the 95% CI is below 1.5 % point.|Risk Difference (RD)|0.1|||||TWO_SIDED|95.0|-0.57|0.48||||||Risk difference between iron isomaltoside/ferric derisomaltose and iron sucrose was assessed for the pooled FERWON-IDA and FERWON-NEPHRO trials (2008 subjects treated with iron isomaltoside/ferric derisomaltose and 1000 subjects treated with iron sucrose) with 95% Newcombe CI adjusted for stratum using the Cochran-Mantel-Haenszel method.||0.48|-0.57|
72505732|NCT02940886|144542659|SUPERIORITY|||||||0.5695|||||||Fisher Exact|||Adjudicated and confirmed treatment-emergent composite cardiovascular AEs. Any treatment emergent composite cardiovascular AEs were included in the statistical evaluation. The overall incidence of adjudicated and confirmed composite cardiovascular AEs was tabulated and compared between the treatment groups by a Fisher's exact test.||||0.5695
72471281|NCT04052425|144466348|SUPERIORITY||least squares mean difference|-0.32|STANDARD_ERROR_OF_MEAN|0.48||0.497|TWO_SIDED|95.0|-1.26|0.62|||mixed-effect model; repeated measurement|||||0.62|-1.26|0.4970
72471282|NCT01189110|144466369|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.81|STANDARD_ERROR_OF_MEAN|0.42||0.74|TWO_SIDED|95.0|0.23|2.83|||Chi-squared|||A two-proportion z-test was used to compare the proportion of self-reported abstinence at 3 weeks between groups.||2.83|0.23|0.74
72471283|NCT00945672|144466422|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) Mean Difference|0.11|STANDARD_ERROR_OF_MEAN|3.959||0.9779|TWO_SIDED|90.0|-6.49|6.71|||Mixed Models Analysis|||Month 3: Mixed model repeated measures (MMRM) analysis with cohort, treatment by time interaction as fixed effects and baseline as covariate.||6.71|-6.49|0.9779
72471284|NCT00945672|144466422|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.58|STANDARD_ERROR_OF_MEAN|3.815||0.8801|TWO_SIDED|90.0|-5.79|6.94|||Mixed Models Analysis|||Month 6: Mixed model repeated measures (MMRM) analysis with cohort, treatment by time interaction as fixed effects and baseline as covariate.||6.94|-5.79|0.8801
72471285|NCT00945672|144466422|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.28|STANDARD_ERROR_OF_MEAN|3.845||0.9412|TWO_SIDED|90.0|-6.13|6.7|||Mixed Models Analysis|||Month 9: Mixed model repeated measures (MMRM) analysis with cohort, treatment by time interaction as fixed effects and baseline as covariate.||6.70|-6.13|0.9412
72471286|NCT00945672|144466422|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.36|STANDARD_ERROR_OF_MEAN|4.223||0.7486|TWO_SIDED|90.0|-8.38|5.66|||Mixed Models Analysis|||Month 13: Mixed model repeated measures (MMRM) analysis with cohort, treatment by time interaction as fixed effects and baseline as covariate.||5.66|-8.38|0.7486
72471287|NCT00945672|144466422|SUPERIORITY_OR_OTHER_LEGACY||L S Mean Difference|8.18|STANDARD_ERROR_OF_MEAN|4.171||0.0534|TWO_SIDED|90.0|1.24|15.12|||Mixed Models Analysis|||Month 18: Mixed model repeated measures (MMRM) analysis with cohort, treatment by time interaction as fixed effects and baseline as covariate.||15.12|1.24|0.0534
72505733|NCT02940886|144542660|SUPERIORITY|||||||0.3913|||||||Log Rank|||The time to first adjudicated and confirmed composite cardiovascular AEs was estimated using the Kaplan-Meier method and the hypothesis of no treatment difference was assessed by a log-rank test.||||0.3913
72505734|NCT02940886|144542662|SUPERIORITY||Odds Ratio (OR)|2.44||||0.0077|TWO_SIDED|95.0|1.27|4.72|||Repeated measures logistic regressioin|||"Week 1~Hb increase of ≥2 g/dL from baseline to week 1.~Proportion of Hb responders to each week was analysed using a repeated measures logistic regression model with treatment, visit, strata, and treatment by visit interaction as fixed effects and baseline value as covariate."||4.72|1.27|0.0077
72505735|NCT02940886|144542662|SUPERIORITY||Odds Ratio (OR)|2.42|||<|0.0001|TWO_SIDED|95.0|1.8|3.26|||Repeated measures logistic regressioin|||"Week 2~Hb increase of ≥2 g/dL from baseline to week 2.~Proportion of Hb responders to each week was analysed using a repeated measures logistic regression model with treatment, visit, strata, and treatment by visit interaction as fixed effects and baseline value as covariate."||3.26|1.80|<0.0001
72505736|NCT02940886|144542662|SUPERIORITY||Odds Ratio (OR)|1.23||||0.1049|TWO_SIDED|95.0|0.96|1.58|||Repeated measures logistic regressioin|||"Week 4~Hb increase of ≥2 g/dL from baseline to week 4.~Proportion of Hb responders to each week was analysed using a repeated measures logistic regression model with treatment, visit, strata, and treatment by visit interaction as fixed effects and baseline value as covariate."||1.58|0.96|0.1049
72471288|NCT00945672|144466422|SUPERIORITY_OR_OTHER_LEGACY||L S Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|3.776||0.998|TWO_SIDED|90.0|-6.29|6.31|||Mixed Models Analysis|||Month 3: Mixed model repeated measures (MMRM) analysis with cohort, treatment by time interaction as fixed effects and baseline as covariate.||6.31|-6.29|0.9980
72471289|NCT00945672|144466422|SUPERIORITY_OR_OTHER_LEGACY||L S Mean Difference|3.35|STANDARD_ERROR_OF_MEAN|3.958||0.4004|TWO_SIDED|90.0|-3.25|9.94|||Mixed Models Analysis|||Month 6: Mixed model repeated measures (MMRM) analysis with cohort, treatment by time interaction as fixed effects and baseline as covariate.||9.94|-3.25|0.4004
72471290|NCT00945672|144466422|SUPERIORITY_OR_OTHER_LEGACY||L S Mean Difference|1.81|STANDARD_ERROR_OF_MEAN|4.214||0.6685|TWO_SIDED|90.0|-5.2|8.82|||Mixed Models Analysis|||Month 9: Mixed model repeated measures (MMRM) analysis with cohort, treatment by time interaction as fixed effects and baseline as covariate.||8.82|-5.20|0.6685
72471291|NCT00945672|144466422|SUPERIORITY_OR_OTHER_LEGACY||L S Mean Difference|4.74|STANDARD_ERROR_OF_MEAN|4.522||0.2968|TWO_SIDED|90.0|-2.77|12.25|||Mixed Models Analysis|||Month 13: Mixed model repeated measures (MMRM) analysis with cohort, treatment by time interaction as fixed effects and baseline as covariate.||12.25|-2.77|0.2968
72505737|NCT02940886|144542662|SUPERIORITY||Odds Ratio (OR)|1.05||||0.7032|TWO_SIDED|95.0|0.8|1.38|||Repeated measures logistic regressioin|||"Week 8~Hb increase of ≥2 g/dL from baseline to week 8.~Proportion of Hb responders to each week was analysed using a repeated measures logistic regression model with treatment, visit, strata, and treatment by visit interaction as fixed effects and baseline value as covariate."||1.38|0.80|0.7032
72505738|NCT02940886|144542663|SUPERIORITY|||||||0.088|||||||Log Rank|||Time to Hb response was estimated using the Kaplan-Meier method and the hypothesis of no treatment difference was assessed by a 2-sided log-rank test.||||0.0880
72505739|NCT02940886|144542664|SUPERIORITY||Odds Ratio (OR)|1.14||||0.242|TWO_SIDED|95.0|0.92|1.41|||Regression, Logistic|||The proportion of subjects who achieved a Hb level of \>12 g/dL at any time from week 1 to week 8 was analysed using a logistic regression model with treatment and strata as fixed effects. The estimated treatment ratio of iron isomaltoside/ferric derisomaltose versus iron sucrose is presented with 95% CI and corresponding p-value.||1.41|0.92|0.2420
72505740|NCT02940886|144542665|SUPERIORITY||Odds Ratio (OR)|1.02||||0.8746|TWO_SIDED|95.0|0.81|1.28|||Regression, Logistic|||"The proportion of subjects who achieved an increase in Hb concentration ≥2 g/dL at any time from week 1 to week 8 was analysed using a logistic regression model with treatment and strata as fixed effects.~The estimated treatment ratio of iron isomaltoside/ferric derisomaltose versus iron sucrose was presented with 95% CI and corresponding p-value."||1.28|0.81|0.8746
72542443|NCT01455545|144614663|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.135||||0.15|TWO_SIDED|95.0|0.618|15.91|||Chi-squared|||Ho = no differences between both groups H1= there are differences between both groups. Cross tabs Chi squared test.||15.91|0.618|0.150
72542444|NCT01455545|144614664|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.096||||0.822|TWO_SIDED|95.0|0.492|2.441|||Chi-squared|||Ho = no differences between both groups H1= there are differences between both groups. Comparison of two proportions. Unilateral test. (1-alpha)=95%. Proportion: 90%. Precision: 10%. Sample size: 35. Sample size adjusted to losses: 41 patients.||2.441|0.492|0.822
72471292|NCT00945672|144466422|SUPERIORITY_OR_OTHER_LEGACY||L S Mean Difference|-1.31|STANDARD_ERROR_OF_MEAN|4.494||0.772|TWO_SIDED|90.0|-8.77|6.16|||Mixed Models Analysis|||Month 18: Mixed model repeated measures (MMRM) analysis with cohort, treatment by time interaction as fixed effects and baseline as covariate.||6.16|-8.77|0.7720
72471293|NCT00945672|144466423|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|2.0|STANDARD_ERROR_OF_MEAN|8.789||0.8205|TWO_SIDED|90.0|-12.68|16.69|||Mixed Models Analysis|||Month 6: Mixed model repeated measures (MMRM) analysis with cohort, treatment by time interaction as fixed effects and baseline as covariate.||16.69|-12.68|0.8205
72471294|NCT00945672|144466423|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|11.37|STANDARD_ERROR_OF_MEAN|8.789||0.2007|TWO_SIDED|90.0|-3.31|26.06|||Mixed Models Analysis|||Month 13: Mixed model repeated measures (MMRM) analysis with cohort, treatment by time interaction as fixed effects and baseline as covariate.||26.06|-3.31|0.2007
72471295|NCT00945672|144466423|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|8.9|STANDARD_ERROR_OF_MEAN|0.8789||0.3152|TWO_SIDED|90.0|-5.78|23.59|||Mixed Models Analysis|||Month 18: Mixed model repeated measures (MMRM) analysis with cohort, treatment by time interaction as fixed effects and baseline as covariate.||23.59|-5.78|0.3152
72471296|NCT00945672|144466423|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-2.2|STANDARD_ERROR_OF_MEAN|8.964||0.8071|TWO_SIDED|90.0|-17.18|12.79|||Mixed Models Analysis|||Month 6: Mixed model repeated measures (MMRM) analysis with cohort, treatment by time interaction as fixed effects and baseline as covariate.||12.79|-17.18|0.8071
72471297|NCT00945672|144466423|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|9.354||0.9918|TWO_SIDED|90.0|-15.72|15.52|||Mixed Models Analysis|||Month 13: Mixed model repeated measures (MMRM) analysis with cohort, treatment by time interaction as fixed effects and baseline as covariate.||15.52|-15.72|0.9918
72471298|NCT00945672|144466423|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-3.01|STANDARD_ERROR_OF_MEAN|9.415||0.7498|TWO_SIDED|90.0|-18.73|12.7|||Mixed Models Analysis|||Month 18: Mixed model repeated measures (MMRM) analysis with cohort, treatment by time interaction as fixed effects and baseline as covariate.||12.70|-18.73|0.7498
72471299|NCT00945672|144466424|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|1.35|STANDARD_ERROR_OF_MEAN|1.91||0.4855|TWO_SIDED|90.0|-1.9|4.6|||ANCOVA|||Month 13: Analysis of covariance (ANCOVA) with cohort by treatment interaction as fixed effect and baseline scores as covariate.||4.60|-1.90|0.4855
72471300|NCT00945672|144466424|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|1.45|STANDARD_ERROR_OF_MEAN|2.185||0.5132|TWO_SIDED|90.0|-2.27|5.16|||ANCOVA|||Month 13: Analysis of covariance (ANCOVA) with cohort by treatment interaction as fixed effect and baseline scores as covariate.||5.16|-2.27|0.5132
72471301|NCT03054337|144466433|SUPERIORITY||Least squares mean difference|0.9|STANDARD_ERROR_OF_MEAN|0.301||0.0045|TWO_SIDED|95.0|0.29|1.51|||ANCOVA|The analysis of covariance (ANCOVA) model included treatment assignment (3 dosed groups; 1 placebo group) and pre-treatment Hb value as a covariate.||||1.51|0.29|0.0045
72471302|NCT03054337|144466433|SUPERIORITY||Least squares mean difference|1.59|STANDARD_ERROR_OF_MEAN|0.306|<|0.0001|TWO_SIDED|95.0|0.98|2.21|||ANCOVA|The ANCOVA model included treatment assignment (3 dosed groups; 1 placebo group) and pre-treatment Hb value as a covariate.||||2.21|0.98|<0.0001
72471303|NCT03054337|144466433|SUPERIORITY||Least squares mean difference|2.09|STANDARD_ERROR_OF_MEAN|0.3|<|0.0001|TWO_SIDED|95.0|1.49|2.7|||ANCOVA|The ANCOVA model included treatment assignment (3 dosed groups; 1 placebo group) and pre-treatment Hb value as a covariate.||||2.70|1.49|<0.0001
72505741|NCT02940886|144542666|SUPERIORITY||Odds Ratio (OR)|4.52|||<|0.0001|TWO_SIDED|95.0|3.58|5.71|||Regression, Logistic|||"Proportion of subject who achieved a s-ferritin level of ≥100 ng/mL AND a TSAT of 20-50% at any time from week 1 to week 8 was analysed using a logistic regression model with treatment and strata as fixed effects.~The estimated treatment ratio of iron isomaltoside/ferric derisomaltose versus iron sucrose is presented with 95% CI and corresponding p-value."||5.71|3.58|<0.0001
72471304|NCT03054337|144466439|SUPERIORITY||Least squares mean difference|0.34|STANDARD_ERROR_OF_MEAN|0.103||0.0018|TWO_SIDED|95.0|0.13|0.55|||ANCOVA|The ANCOVA model will include treatment assignment (3 dosed groups; 1 placebo group) and pre-treatment Hb value as a covariate.||RBC Count||0.55|0.13|0.0018
72471305|NCT03054337|144466439|SUPERIORITY||Least squares mean difference|0.51|STANDARD_ERROR_OF_MEAN|0.103|<|0.0001|TWO_SIDED|95.0|0.3|0.72|||ANCOVA|The ANCOVA model will include treatment assignment (3 dosed groups; 1 placebo group) and pre-treatment Hb value as a covariate.||RBC Count||0.72|0.30|<0.0001
72471306|NCT03054337|144466439|SUPERIORITY||Least squares mean difference|0.66|STANDARD_ERROR_OF_MEAN|0.102|<|0.0001|TWO_SIDED|95.0|0.45|0.86|||ANCOVA|The ANCOVA model will include treatment assignment (3 dosed groups; 1 placebo group) and pre-treatment Hb value as a covariate.||RBC Count||0.86|0.45|<0.0001
72471307|NCT03054337|144466439|SUPERIORITY||Least squares mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.005||0.7804|TWO_SIDED|95.0|-0.01|0.01|||ANCOVA|The ANCOVA model will include treatment assignment (3 dosed groups; 1 placebo group) and pre-treatment Hb value as a covariate.||Absolute Reticulocyte Count||0.01|-0.01|0.7804
72471308|NCT03054337|144466439|SUPERIORITY||Least squares mean difference|0.01|STANDARD_ERROR_OF_MEAN|0.005||0.0986|TWO_SIDED|95.0|0.0|0.02|||ANCOVA|The ANCOVA model will include treatment assignment (3 dosed groups; 1 placebo group) and pre-treatment Hb value as a covariate.||Absolute Reticulocyte Count||0.02|-0.00|0.0986
72471309|NCT03054337|144466439|SUPERIORITY||Least squares mean difference|0.01|STANDARD_ERROR_OF_MEAN|0.005||0.1661|TWO_SIDED|95.0|0.0|0.02|||ANCOVA|The ANCOVA model will include treatment assignment (3 dosed groups; 1 placebo group) and pre-treatment Hb value as a covariate.||Absolute Reticulocyte Count||0.02|-0.00|0.1661
72471310|NCT03054337|144466441|SUPERIORITY||Least squares mean difference|3.3|STANDARD_ERROR_OF_MEAN|0.942||0.001|TWO_SIDED|95.0|1.4|5.2|||ANCOVA|The ANCOVA model will include treatment assignment (3 dosed groups; 1 placebo group) and pre-treatment Hb value as a covariate.||Hematocrit||5.20|1.40|0.0010
72505742|NCT02940886|144542667|SUPERIORITY||Mean Difference (Final Values)|0.26|||<|0.0001|TWO_SIDED|95.0|0.19|0.34|||Mixed model for repeated measures|||"Week 1~Change in Hb concentration from baseline to week 1 was analysed using a MMRM including treatment, week, treatment-by-week interaction, and strata as factors and baseline value and baseline value-by-week interaction as covariates."||0.34|0.19|<0.0001
72542445|NCT01455545|144614665|SUPERIORITY_OR_OTHER|||||||0.003||95.0|||||t-test, 2 sided|||||||0.003
72542446|NCT01455545|144614665|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.038||||0.005|TWO_SIDED|95.0|1.012|1.065|||Regression, Logistic|||||1.065|1.012|0.005
72471311|NCT03054337|144466441|SUPERIORITY||Least squares mean difference|5.3|STANDARD_ERROR_OF_MEAN|0.953|<|0.0001|TWO_SIDED|95.0|3.38|7.22|||ANCOVA|The ANCOVA model will include treatment assignment (3 dosed groups; 1 placebo group) and pre-treatment Hb value as a covariate.||Hematocrit||7.22|3.38|<0.0001
72505743|NCT02940886|144542667|SUPERIORITY||Mean Difference (Final Values)|0.29|||<|0.0001|TWO_SIDED|95.0|0.19|0.38|||Mixed model for repeated measures|||"Week 2~Change in Hb concentration from baseline to week 2 was analysed using a MMRM including treatment, week, treatment-by-week interaction, and strata as factors and baseline value and baseline value-by-week interaction as covariates."||0.38|0.19|<0.0001
72471312|NCT03054337|144466441|SUPERIORITY||Least squares mean difference|7.24|STANDARD_ERROR_OF_MEAN|0.93|<|0.0001|TWO_SIDED|95.0|5.37|9.11|||ANCOVA|The ANCOVA model will include treatment assignment (3 dosed groups; 1 placebo group) and pre-treatment Hb value as a covariate.||Hematocrit||9.11|5.37|<0.0001
72471313|NCT03054337|144466441|SUPERIORITY||Least squares mean difference|-0.08|STANDARD_ERROR_OF_MEAN|0.152||0.5889|TWO_SIDED|95.0|-0.39|0.22|||ANCOVA|The ANCOVA model will include treatment assignment (3 dosed groups; 1 placebo group) and pre-treatment Hb value as a covariate.||Reticulocytes||0.22|-0.39|0.5889
72471314|NCT03054337|144466441|SUPERIORITY||Least squares mean difference|0.04|STANDARD_ERROR_OF_MEAN|0.151||0.8074|TWO_SIDED|95.0|-0.27|0.34|||ANCOVA|The ANCOVA model will include treatment assignment (3 dosed groups; 1 placebo group) and pre-treatment Hb value as a covariate.||Reticulocytes||0.34|-0.27|0.8074
72471315|NCT03054337|144466441|SUPERIORITY||Least squares mean difference|-0.06|STANDARD_ERROR_OF_MEAN|0.148||0.6952|TWO_SIDED|95.0|-0.36|0.24|||ANCOVA|The ANCOVA model will include treatment assignment (3 dosed groups; 1 placebo group) and pre-treatment Hb value as a covariate.||Reticulocytes||0.24|-0.36|0.6952
72471316|NCT03054337|144466443|SUPERIORITY|||||||0.3702|||||||ANCOVA|test of treatment group difference based on ANCOVA model||Iron||||0.3702
72505744|NCT02940886|144542667|SUPERIORITY||Mean Difference (Final Values)|0.09||||0.1091|TWO_SIDED|95.0|-0.02|0.2|||Mixed model for repeated measures|||"Week 4~Change in Hb concentration from baseline to week 4 was analysed using a MMRM including treatment, week, treatment-by-week interaction, and strata as factors and baseline value and baseline value-by-week interaction as covariates."||0.20|-0.02|0.1091
72505745|NCT02940886|144542668|SUPERIORITY||Mean Difference (Final Values)|267.7|||<|0.0001|TWO_SIDED|95.0|246.3|289.0|||Mixed model for repeated measures|||"Week 1~Change in concentrations of s-ferritin from baseline to week 1 was analysed using a MMRM including treatment, week, treatment-by-week interaction, and strata as factors and baseline value and baseline value-by-week interaction as covariates.~The estimated treatment differences based on the least square means of the treatment-by-week interaction effects are presented by week, include 95% CIs and corresponding p-value."||289.0|246.3|<0.0001
72505746|NCT02940886|144542668|SUPERIORITY||Mean Difference (Final Values)|41.7|||<|0.0001|TWO_SIDED|95.0|25.6|57.8|||Mixed model for repeated measures|||"Week 2~Change in concentrations of s-ferritin from baseline to week 2 was analysed using MMRM including treatment, week, treatment-by-week interaction, and strata as factors and baseline value and baseline value-by-week interaction as covariates.~The estimated treatment differences based on the least square means of the treatment-by-week interaction effects are presented by week, include 95% CIs and corresponding p-value."||57.8|25.6|<0.0001
72505747|NCT02940886|144542668|SUPERIORITY||Mean Difference (Final Values)|-9.0||||0.115|TWO_SIDED|95.0|-20.3|2.2|||Mixed model for repeated measures|||"Week 4~Change in concentrations of s-ferritin from baseline to week 4 was analysed using MMRM including treatment, week, treatment-by-week interaction, and strata as factors and baseline value and baseline value-by-week interaction as covariates.~The estimated treatment differences based on the least square means of the treatment-by-week interaction effects are presented by week, include 95% CIs and corresponding p-value."||2.2|-20.3|0.1150
72471317|NCT03054337|144466443|SUPERIORITY|||||||0.5524|||||||ANCOVA|test of treatment group difference based on ANCOVA model||Iron||||0.5524
72471318|NCT03054337|144466443|SUPERIORITY|||||||0.1589|||||||ANCOVA|test of treatment group difference based on ANCOVA model||Iron||||0.1589
72471319|NCT03054337|144466443|SUPERIORITY|||||||0.0092|||||||ANCOVA|test of treatment group difference based on ANCOVA model||TIBC||||0.0092
72471320|NCT03054337|144466443|SUPERIORITY||||||<|0.0001|||||||ANCOVA|test of treatment group difference based on ANCOVA model||TIBC||||<0.0001
72471321|NCT03054337|144466443|SUPERIORITY||||||<|0.0001|||||||ANCOVA|test of treatment group difference based on ANCOVA model||TIBC||||<0.0001
72471322|NCT03054337|144466445|SUPERIORITY|||||||0.9092|||||||ANCOVA|test of treatment group difference based on ANCOVA model||||||0.9092
72471323|NCT03054337|144466445|SUPERIORITY|||||||0.1484|||||||ANCOVA|test of treatment group difference based on ANCOVA model||||||0.1484
72471324|NCT03054337|144466445|SUPERIORITY|||||||0.1313|||||||ANCOVA|test of treatment group difference based on ANCOVA model||||||0.1313
72471325|NCT03054337|144466447|SUPERIORITY|||||||0.108|||||||ANCOVA|test of treatment group difference based on ANCOVA model||Ferritin||||0.1080
72471326|NCT03054337|144466447|SUPERIORITY|||||||0.0002|||||||ANCOVA|test of treatment group difference based on ANCOVA model||Ferritin||||0.0002
72471327|NCT03054337|144466447|SUPERIORITY||||||<|0.0001|||||||ANCOVA|test of treatment group difference based on ANCOVA model||Ferritin||||<0.0001
72471328|NCT03054337|144466447|SUPERIORITY|||||||0.0672|||||||ANCOVA|test of treatment group difference based on ANCOVA model||Hepcidin||||0.0672
72471329|NCT03054337|144466447|SUPERIORITY|||||||0.0004|||||||ANCOVA|test of treatment group difference based on ANCOVA model||Hepcidin||||0.0004
72471330|NCT03054337|144466447|SUPERIORITY||||||<|0.0001|||||||ANCOVA|test of treatment group difference based on ANCOVA model||Hepcidin||||<0.0001
72471331|NCT03054337|144466454|SUPERIORITY|||||||0.0895|||||||Fisher Exact|||||||0.0895
72471332|NCT03054337|144466454|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.000
72471333|NCT03054337|144466454|SUPERIORITY|||||||0.3845|||||||Fisher Exact|||||||0.3845
72471334|NCT01762904|144466459|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Kruskal-Wallis|||||||<0.05
72471335|NCT01762904|144466460|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Kruskal-Wallis|||||||<0.05
72471336|NCT01762904|144466461|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Kruskal-Wallis|||||||<0.05
72505748|NCT02940886|144542668|SUPERIORITY||Mean Difference (Final Values)|-8.3||||0.0812|TWO_SIDED|95.0|-17.7|1.0|||Mixed model for repeated measures|||"Week 8~Change in concentrations of s-ferritin from baseline to week 8 was analysed using MMRM including treatment, week, treatment-by-week interaction, and strata as factors and baseline value and baseline value-by-week interaction as covariates.~The estimated treatment differences based on the least square means of the treatment-by-week interaction effects are presented by week, include 95% CIs and corresponding p-value."||1.0|-17.7|0.0812
72505749|NCT02940886|144542669|SUPERIORITY||Mean Difference (Final Values)|11.4|||<|0.0001|TWO_SIDED|95.0|10.1|12.7|||Mixed model for repeated measures|||"Week 1~Change in TSAT from baseline to week 1 was analysed using MMRM including treatment, week, treatment-by-week interaction, and strata as factors and baseline value and baseline value-by-week interaction as covariates.~The estimated treatment differences based on the least square means of the treatment-by-week interaction effects are presented by week, include 95% CIs and corresponding p-value."||12.7|10.1|<0.0001
72505750|NCT02940886|144542669|SUPERIORITY||Mean Difference (Final Values)|2.4||||0.0001|TWO_SIDED|95.0|1.2|3.6|||Mixed model for repeated measures|||"Week 2~Change in TSAT from baseline to week 2 was analysed using MMRM including treatment, week, treatment-by-week interaction, and strata as factors and baseline value and baseline value-by-week interaction as covariates.~The estimated treatment differences based on the least square means of the treatment-by-week interaction effects are presented by week, include 95% CIs and corresponding p-value."||3.6|1.2|0.0001
72395637|NCT00137046|144297519|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.797|STANDARD_ERROR_OF_MEAN|0.167||||90.0|-1.073|-0.522|||ANCOVA|||Month 6; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||-0.522|-1.073|
72471337|NCT00447590|144466463|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||2-sided Exact Binomial Test|||p-Value is from a 2-sided exact binomial test to test the null hypothesis that 30% of subjects have at least 30% EWL.||||<0.0001
72471338|NCT01028677|144466470|SUPERIORITY_OR_OTHER|||||||0.61|TWO_SIDED|||||Not adjusted for multiple comparisons|t-test, 1 sided|||Analysis of fear emotion||||.61
72471339|NCT01028677|144466471|SUPERIORITY|||||||0.008|||||||t-test, 2 sided|||Positive Symptoms||||0.008
72471340|NCT01028677|144466471|SUPERIORITY|||||||0.002|||||||t-test, 2 sided|||Negative Symptoms||||0.002
72471341|NCT01028677|144466471|SUPERIORITY|||||||0.04|||||||t-test, 2 sided|||General Symptoms||||0.04
72542447|NCT01455545|144614666|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.35||||0.013|TWO_SIDED|95.0|0.153|0.799|||Regression, Logistic|||Ho = no differences between both groups H1= there are differences between both groups.||0.799|0.153|0.013
72576692|NCT01191944|144680195|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.51|STANDARD_ERROR_OF_MEAN|1.5581||0.0254|TWO_SIDED|95.0|0.437|6.583|||ANCOVA|||||6.583|0.437|0.0254
72395638|NCT00137046|144297519|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.667|STANDARD_ERROR_OF_MEAN|0.171||||90.0|-0.949|-0.384|||ANCOVA|||Month 9; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||-0.384|-0.949|
72471342|NCT01028677|144466471|SUPERIORITY|||||||0.05|||||||t-test, 2 sided|||Positive Symptoms||||0.05
72471343|NCT01028677|144466471|SUPERIORITY|||||||0.08|||||||t-test, 2 sided|||Negative Symptoms||||0.08
72471344|NCT01028677|144466471|SUPERIORITY|||||||0.025|||||||t-test, 2 sided|||General Symptoms||||0.025
72471345|NCT01028677|144466473|SUPERIORITY_OR_OTHER|||||||0.03|TWO_SIDED|||||Not adjusted for multiple comparisons|t-test, 2 sided|||||||.03
72471346|NCT01028677|144466475|SUPERIORITY_OR_OTHER|||||||0.784|TWO_SIDED|||||Not adjusted for multiple comparisons|t-test, 2 sided|||IRI-total||||.784
72471347|NCT01028677|144466475|SUPERIORITY_OR_OTHER|||||||1|||||||t-test, 2 sided|||Distress analysis||||1.00
72471348|NCT01028677|144466475|SUPERIORITY_OR_OTHER|||||||0.03|||||||t-test, 2 sided|||Perspective-Taking||||.03
72471349|NCT01028677|144466475|SUPERIORITY_OR_OTHER|||||||0.135|||||||t-test, 2 sided|||Emotional empathy analysis||||.135
72471350|NCT01028677|144466475|SUPERIORITY_OR_OTHER|||||||0.681|TWO_SIDED||||||t-test, 2 sided|||Fantasy Analysis||||.681
72576693|NCT01191944|144680196|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.621|STANDARD_ERROR_OF_MEAN|2.2658||0.7843|TWO_SIDED|95.0|-3.848|5.09|||ANCOVA|||||5.090|-3.848|0.7843
72471351|NCT01028677|144466475|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||t-test, 2 sided|||Distress analysis||||1.00
72471352|NCT04079634|144466522|OTHER|||||||0.02|||||||t-test, 2 sided|||||||0.02
72471353|NCT04148989|144466523|SUPERIORITY||Mean Difference (Final Values)|-12.8|||<|0.001|TWO_SIDED|95.0|-18.6|-7.0|||Regression, gamma||Change in emergency department door-to-antibiotic time (minutes) associated with Code Sepsis implementation derived from adjusted differences-in-differences analysis|Differences-in-differences analysis using multivariable gamma regression to estimate the change in outcome after versus before intervention implementation at the intervention site adjusted for the change observed at control sites and for subjects' age, sex, Elixhauser Comorbidity Score, ED arrival via ambulance, English language preference, temperature, systolic blood pressure, Acute Physiology Score, Sequential Organ Failure Assessment score, and ED-diagnosed source of infection.||-7.0|-18.6|<0.001
72471354|NCT04148989|144466524|SUPERIORITY||Odds Ratio (OR)|0.89||||0.45|TWO_SIDED|95.0|0.68|1.19|||Regression, Logistic||Change in all-cause 30-day mortality risk associated with Code Sepsis implementation derived from adjusted differences-in-differences analysis|Differences-in-differences analysis using multivariable logistic regression to estimate the change in outcome after versus before intervention implementation at the intervention site adjusted for the change observed at control sites and for subjects' age, sex, Elixhauser Comorbidity Score, ED arrival via ambulance, English language preference, temperature, systolic blood pressure, Acute Physiology Score, Sequential Organ Failure Assessment score, and ED-diagnosed source of infection.||1.19|0.68|0.45
72471355|NCT04148989|144466525|SUPERIORITY||Odds Ratio (OR)|0.83||||0.1|TWO_SIDED|95.0|0.67|1.04|||Regression, Logistic||Change in all-cause 1-year mortality risk associated with Code Sepsis implementation derived from adjusted differences-in-differences analysis|Differences-in-differences analysis using multivariable logistic regression to estimate the change in outcome after versus before intervention implementation at the intervention site adjusted for the change observed at control sites and for subjects' age, sex, Elixhauser Comorbidity Score, ED arrival via ambulance, English language preference, temperature, systolic blood pressure, Acute Physiology Score, Sequential Organ Failure Assessment score, and ED-diagnosed source of infection.||1.04|0.67|0.10
72471356|NCT04148989|144466526|SUPERIORITY||Odds Ratio (OR)|0.77||||0.15|TWO_SIDED|95.0|0.53|1.1|||Regression, Logistic|||Differences-in-differences analysis using multivariable logistic regression to estimate the change in outcome after versus before intervention implementation at the intervention site adjusted for the change observed at control sites and for subjects' age, sex, Elixhauser Comorbidity Score, ED arrival via ambulance, English language preference, temperature, systolic blood pressure, Acute Physiology Score, Sequential Organ Failure Assessment score, and ED-diagnosed source of infection.|Change in all-cause in-hospital mortality risk associated with Code Sepsis implementation derived from adjusted differences-in-differences analysis|1.10|0.53|0.15
72471357|NCT04148989|144466527|SUPERIORITY||Mean Difference (Final Values)|0.3||||0.71|TWO_SIDED|95.0|-1.4|2.1|||Regression, gamma||Change in hospital charges ($1000s) associated with Code Sepsis implementation derived from adjusted differences-in-differences analysis|Differences-in-differences analysis using multivariable gamma regression to estimate the change in outcome after versus before intervention implementation at the intervention site adjusted for the change observed at control sites and for subjects' age, sex, Elixhauser Comorbidity Score, ED arrival via ambulance, English language preference, temperature, systolic blood pressure, Acute Physiology Score, Sequential Organ Failure Assessment score, and ED-diagnosed source of infection.||2.1|-1.4|0.71
72395639|NCT00137046|144297519|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.826|STANDARD_ERROR_OF_MEAN|0.181||||90.0|-1.123|-0.528|||ANCOVA|||Month 12; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||-0.528|-1.123|
72471358|NCT04148989|144466528|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.19|TWO_SIDED|95.0|-0.4|0.1|||Regression, gamma||Change in hospital length of stay (days) associated with Code Sepsis implementation derived from adjusted differences-in-differences analysis|Differences-in-differences analysis using multivariable gamma regression to estimate the change in outcome after versus before intervention implementation at the intervention site adjusted for the change observed at control sites and for subjects' age, sex, Elixhauser Comorbidity Score, ED arrival via ambulance, English language preference, temperature, systolic blood pressure, Acute Physiology Score, Sequential Organ Failure Assessment score, and ED-diagnosed source of infection.||0.1|-0.4|0.19
72471359|NCT04148989|144466529|SUPERIORITY|Multiple imputation was employed to account for missing covariate data affecting 3.6% of eligible patients.|Odds Ratio (OR)|1.1||||0.005|TWO_SIDED|95.0|1.03|1.17||Model adjusted for age, sex, Elixhauser Comorbidity Score, ED arrival via ambulance, language preference, temperature, systolic blood pressure, Acute Physiology Score, Sequential Organ Failure Assessment score, and ED-diagnosed source of infection.|Regression, Logistic||Change in antimicrobial treatment risk associated with Code Sepsis implementation derived from adjusted differences-in-differences analysis.|Differences-in-differences analysis using multivariable logistic regression to estimate the change in outcome after versus before intervention implementation at the intervention site adjusted for the change observed at control sites and for prespecified covariates.||1.17|1.03|0.005
72471360|NCT04148989|144466530|SUPERIORITY||Odds Ratio (OR)|1.09||||0.73|TWO_SIDED|95.0|0.68|1.75|||Regression, Logistic||Change in risk for possible antimicrobial-associated adverse event associated with Code Sepsis implementation derived from adjusted differences-in-differences analysis|Differences-in-differences analysis using multivariable logistic regression to estimate the change in outcome after versus before intervention implementation at the intervention site adjusted for the change observed at control sites and for subjects' age, sex, Elixhauser Comorbidity Score, ED arrival via ambulance, English language preference, temperature, systolic blood pressure, Acute Physiology Score, Sequential Organ Failure Assessment score, and ED-diagnosed source of infection.||1.75|0.68|0.73
72505751|NCT02940886|144542669|SUPERIORITY||Mean Difference (Final Values)|1.2||||0.0162|TWO_SIDED|95.0|0.2|2.1|||Mixed model for repeated measures|||"Week 4~Change in TSAT from baseline to week 4 was analysed using MMRM including treatment, week, treatment-by-week interaction, and strata as factors and baseline value and baseline value-by-week interaction as covariates.~The estimated treatment differences based on the least square means of the treatment-by-week interaction effects are presented by week, include 95% CIs and corresponding p-value."||2.1|0.2|0.0162
72505752|NCT02940886|144542669|SUPERIORITY||Mean Difference (Final Values)|0.9||||0.0569|TWO_SIDED|95.0|0.0|1.8|||Mixed model for repeated measures|||"Week 8~Change in TSAT from baseline to week 8 was analysed using MMRM including treatment, week, treatment-by-week interaction, and strata as factors and baseline value and baseline value-by-week interaction as covariates.~The estimated treatment differences based on the least square means of the treatment-by-week interaction effects are presented by week, include 95% CIs and corresponding p-value."||1.8|0.0|0.0569
72505753|NCT02940886|144542670|SUPERIORITY||Mean Difference (Final Values)|43.7|||<|0.0001|TWO_SIDED|95.0|38.1|49.3|||Mixed model for repeated measures|||"Week 1~Change in s-iron from baseline to week 1 was analysed using a Mixed Model for Repeated Measurement (MMRM) including treatment, week, treatment-by-week interaction, and strata as factors and baseline value and baseline value-by-week interaction as covariates.~The estimated treatment differences based on the least square means of the treatment-by-week interaction effects are presented by week, including 95% CIs and corresponding p-value."||49.3|38.1|<0.0001
72471361|NCT04148989|144466531|SUPERIORITY|Multiple imputation was employed to account for missing covariate data affecting 3.6% of eligible patients.|Odds Ratio (OR)|1.02||||0.9|TWO_SIDED|95.0|0.78|1.33||Model adjusted for age, sex, Elixhauser Comorbidity Score, ED arrival via ambulance, language preference, temperature, systolic blood pressure, Acute Physiology Score, Sequential Organ Failure Assessment score, and ED-diagnosed source of infection.|Regression, Logistic|||Differences-in-differences analysis using multivariable logistic regression to estimate the change in outcome after versus before intervention implementation at the intervention site adjusted for the change observed at control sites and for prespecified covariates.|Change in risk for possible antimicrobial-associated adverse event associated with Code Sepsis implementation derived from adjusted differences-in-differences analysis.|1.33|0.78|0.90
72505754|NCT02940886|144542670|SUPERIORITY||Mean Difference (Final Values)|5.0||||0.0375|TWO_SIDED|95.0|0.3|9.8|||Mixed model for repeated measures|||"Week 2~Change in s-iron from baseline to week 2 was analysed using a Mixed Model for Repeated Measurement (MMRM) including treatment, week, treatment-by-week interaction, and strata as factors and baseline value and baseline value-by-week interaction as covariates.~The estimated treatment differences based on the least square means of the treatment-by-week interaction effects are presented by week, including 95% CIs and corresponding p-value."||9.8|0.3|0.0375
72395640|NCT00137046|144297519|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.61|STANDARD_ERROR_OF_MEAN|0.19||||90.0|-0.923|-0.296|||ANCOVA|||Month 15; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||-0.296|-0.923|
72395641|NCT00137046|144297519|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.577|STANDARD_ERROR_OF_MEAN|0.202||||90.0|-0.91|-0.245|||ANCOVA|||Month 18; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||-0.245|-0.910|
72395642|NCT00137046|144297519|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.613|STANDARD_ERROR_OF_MEAN|0.212||||90.0|-0.962|-0.263|||ANCOVA|||Month 21; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||-0.263|-0.962|
72395643|NCT00137046|144297519|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.385|STANDARD_ERROR_OF_MEAN|0.213||||90.0|-0.736|-0.034|||ANCOVA|||Month 24; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||-0.034|-0.736|
72395644|NCT00137046|144297519|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.15|STANDARD_ERROR_OF_MEAN|0.211||||90.0|-0.197|0.497|||ANCOVA|||Follow-up Month 1; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||0.497|-0.197|
72395645|NCT00137046|144297519|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.166|STANDARD_ERROR_OF_MEAN|0.198||||90.0|-0.16|0.492|||ANCOVA|||Follow-up Month 3; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||0.492|-0.160|
72395646|NCT00137046|144297519|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.069|STANDARD_ERROR_OF_MEAN|0.208||||90.0|-0.274|0.411|||ANCOVA|||Follow-up Month 6; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||0.411|-0.274|
72395647|NCT00137046|144297519|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.46|STANDARD_ERROR_OF_MEAN|0.252||||90.0|-0.876|-0.043|||ANCOVA|||Extension Month 1; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||-0.043|-0.876|
72395648|NCT00137046|144297519|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.579|STANDARD_ERROR_OF_MEAN|0.247||||90.0|-0.986|-0.172|||ANCOVA|||Extension Month 3; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||-0.172|-0.986|
72505755|NCT02940886|144542670|SUPERIORITY||Mean Difference (Final Values)|-0.8||||0.6027|TWO_SIDED|95.0|-4.0|2.3|||Mixed model for repeated measures|||"Week 4~Change in s-iron from baseline to week 4 was analysed using a Mixed Model for Repeated Measurement (MMRM) including treatment, week, treatment-by-week interaction, and strata as factors and baseline value and baseline value-by-week interaction as covariates.~The estimated treatment differences based on the least square means of the treatment-by-week interaction effects are presented by week, including 95% CIs and corresponding p-value."||2.3|-4.0|0.6027
72505756|NCT02940886|144542670|SUPERIORITY||Mean Difference (Final Values)|0.4||||0.8207|TWO_SIDED|95.0|-2.7|3.4|||Mixed model for repeated measures|||"Week 8~Change in s-iron from baseline to week 8 was analysed using a Mixed Model for Repeated Measurement (MMRM) including treatment, week, treatment-by-week interaction, and strata as factors and baseline value and baseline value-by-week interaction as covariates.~The estimated treatment differences based on the least square means of the treatment-by-week interaction effects are presented by week, including 95% CIs and corresponding p-value."||3.4|-2.7|0.8207
72505757|NCT02940886|144542671|SUPERIORITY||Mean Difference (Final Values)|1.02||||0.0422|TWO_SIDED|95.0|0.04|2.01|||Mixed model for repeated measures|||"Week 1~Change in fatigue symptoms score from baseline to week 1 was analysed using MMRM including treatment, week, treatment-by-week interaction, and strata as factors and baseline score and baseline score-by-week interaction as covariates."||2.01|0.04|0.0422
72505758|NCT02940886|144542671|SUPERIORITY||Mean Difference (Final Values)|-0.39||||0.4646|TWO_SIDED|95.0|-1.44|0.66|||Mixed model for repeated measures|||"Week 2~Change in fatigue symptoms score from baseline to week 2 was analysed using MMRM including treatment, week, treatment-by-week interaction, and strata as factors and baseline score and baseline score-by-week interaction as covariates."||0.66|-1.44|0.4646
72576694|NCT01191944|144680197|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.369|STANDARD_ERROR_OF_MEAN|0.4901||0.4529|TWO_SIDED|95.0|-0.598|1.335|||ANCOVA|||||1.335|-0.598|0.4529
72576695|NCT01191944|144680198|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.53|STANDARD_ERROR_OF_MEAN|0.4437||0.2338|TWO_SIDED|95.0|-1.405|0.345|||ANCOVA|||||0.345|-1.405|0.2338
72395649|NCT00137046|144297519|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.46|STANDARD_ERROR_OF_MEAN|0.255||||90.0|-0.88|-0.04|||ANCOVA|||Extension Month 6; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||-0.040|-0.880|
72395650|NCT00137046|144297519|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.385|STANDARD_ERROR_OF_MEAN|0.265||||90.0|-0.822|0.053|||ANCOVA|||Extension Month 9; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||0.053|-0.822|
72395651|NCT00137046|144297519|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.93|STANDARD_ERROR_OF_MEAN|0.268||||90.0|-1.372|-0.487|||ANCOVA|||Extension Month 12; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||-0.487|-1.372|
72395652|NCT00137046|144297519|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.823|STANDARD_ERROR_OF_MEAN|0.286||||90.0|-1.296|-0.351|||ANCOVA|||Extension Month 15; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||-0.351|-1.296|
72395653|NCT00137046|144297519|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.525|STANDARD_ERROR_OF_MEAN|0.267||||90.0|-0.965|-0.084|||ANCOVA|||Extension Month 18; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||-0.084|-0.965|
72395654|NCT00137046|144297519|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.647|STANDARD_ERROR_OF_MEAN|0.276||||90.0|-1.104|-0.191|||ANCOVA|||Extension Month 21; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||-0.191|-1.104|
72395655|NCT00137046|144297519|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.853|STANDARD_ERROR_OF_MEAN|0.295||||90.0|-1.34|-0.367|||ANCOVA|||Extension Month 24; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||-0.367|-1.340|
72505759|NCT02940886|144542671|SUPERIORITY||Mean Difference (Final Values)|-0.31||||0.5703|TWO_SIDED|95.0|-1.39|0.76|||Mixed model for repeated measures|||"Week 8~Change in fatigue symptoms score from baseline to week 8 was analysed using MMRM including treatment, week, treatment-by-week interaction, and strata as factors and baseline score and baseline score-by-week interaction as covariates."||0.76|-1.39|0.5703
72395656|NCT00137046|144297519|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.39|STANDARD_ERROR_OF_MEAN|0.303||||90.0|-0.89|0.111|||ANCOVA|||Extension Month 27; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||0.111|-0.890|
72395657|NCT00137046|144297519|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.636|STANDARD_ERROR_OF_MEAN|0.293||||90.0|-1.119|-0.153|||ANCOVA|||Extension Month 30; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||-0.153|-1.119|
72395658|NCT00137046|144297519|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.522|STANDARD_ERROR_OF_MEAN|0.29||||90.0|-1.0|-0.043|||ANCOVA|||Extension Month 33; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||-0.043|-1.000|
72395659|NCT00137046|144297519|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.744|STANDARD_ERROR_OF_MEAN|0.346||||90.0|-1.315|-0.173|||ANCOVA|||Extension Month 36; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||-0.173|-1.315|
72395660|NCT00137046|144297519|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.378|STANDARD_ERROR_OF_MEAN|0.628||||90.0|-2.42|-0.335|||ANCOVA|||Extension Month 39; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||-0.335|-2.420|
72395661|NCT00137046|144297519|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.72|STANDARD_ERROR_OF_MEAN|0.28||||90.0|-1.183|-0.258|||ANCOVA|||Extension Month 39 (LOCF); Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||-0.258|-1.183|
72395662|NCT00137046|144297519|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.061|STANDARD_ERROR_OF_MEAN|0.323||||90.0|-0.594|0.472|||ANCOVA|||Extension Follow Up Month 3; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||0.472|-0.594|
72395663|NCT01414010|144297526|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||"Statistical analysis was performed using a variety of computer packages including XLstat, NCSS 2007, R and NCSS 2010"||||<0.05
72395664|NCT01648205|144297527|SUPERIORITY||Mean Difference (Final Values)|-1.6|STANDARD_DEVIATION|26.8||0.7958|TWO_SIDED|95.0|-14.1|11.0|||t-test, 2 sided|Paired t-test was used||||11.0|-14.1|0.7958
72505760|NCT01306058|144542692|NON_INFERIORITY|Paired T-test. Two tailed.|||||<|0.05|||||||Wilcoxon signed rank test|||||||<0.05
72505761|NCT01306058|144542693|NON_INFERIORITY|Paired T-test. Two tailed.|||||<|0.0001||||||Cycle 1 day 15 vs. cycle 1 day 1|Wilcoxon signed rank test|||||||<0.0001
72576696|NCT01191944|144680199|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.562|STANDARD_ERROR_OF_MEAN|0.2509||0.0263|TWO_SIDED|95.0|0.067|1.057|||ANCOVA|||||1.057|0.067|0.0263
72576697|NCT01191944|144680200|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.031|STANDARD_ERROR_OF_MEAN|0.3727||0.9337|TWO_SIDED|95.0|-0.704|0.766|||ANCOVA|||||0.766|-0.704|0.9337
72395665|NCT01648205|144297528|SUPERIORITY||Median Difference (Final Values)|8.4|STANDARD_DEVIATION|35.9||0.3369|TWO_SIDED|95.0|-9.5|26.2|||t-test, 2 sided|Paired t-test was used||||26.2|-9.5|0.3369
72395666|NCT02142959|144297538|SUPERIORITY||LS Mean Difference Final Values|-0.1||||0.237|TWO_SIDED|65.0|-0.2|0.0||Omaveloxolone treatment arms were compared with Vehicle Lotion using a hierarchical testing strategy to control the overall type I error.|Mixed Models Analysis|Fixed factors: treatment grp \& wk of visit; covariates of site, smoking status \& surgery. Missing data imputed using each patient's worst-observation.||Comparison of omaveloxolone lotion pooled (0.5% and 3%) versus vehicle lotion||0.0|-0.2|0.237
72395667|NCT02142959|144297538|SUPERIORITY||LS Mean Difference Final Values|-0.1|||>|0.05|TWO_SIDED|95.0|-0.2|0.0||Omaveloxolone treatment arms were compared with Vehicle Lotion using a hierarchical testing strategy to control the overall type I error.|Mixed Models Analysis|Fixed factor: treatment grp \& visit wk; Covariates: site, smoking status \& breast surgery. Missing data imputed using each patient's worst-observation||Comparison of Omaveloxolone Lotion 0.5% versus Vehicle Lotion||0.0|-0.2|>0.05
72395668|NCT02142959|144297538|SUPERIORITY||LS Mean Difference Final Values|0.0|||>|0.05|TWO_SIDED|95.0|-0.1|0.1|||Mixed Models Analysis|Fixed factor: treatment grp \& visit wk; Covariates: site, smoking status \& breast surgery. Missing data imputed using each patient's worst-observation||Comparison of Omaveloxolone Lotion 3% versus Vehicle Lotion||0.1|-0.1|>0.05
72395669|NCT03700671|144297617|SUPERIORITY||||||<|0.01|TWO_SIDED|95.0||||A P-value of 0.05 was used as the threshold for significance|ANOVA|||A sample size of 38 using G\*Power 3.1 software was calculated based on previously published data in which the mean difference between HIIT and moderate intensity continuous training (MICT) was 3.2 ml.kg-1.min-1 with a pooled standard deviation of 3 ml.kg-1.min-1. Statistical significance was set at = 0.05 and power set to 0.95. To allow for 10% attrition 42 individuals were recruited to the study||||<0.01
72395670|NCT03700671|144297618|SUPERIORITY||||||<|0.01|TWO_SIDED|95.0||||0.05 was used as a threshold for significance|ANOVA|||||||<0.01
72505762|NCT01306058|144542693|NON_INFERIORITY|Cycle 2 day 1 vs. cycle 1 day 1. Paired T-test. Two tailed.|||||<|0.0001|||||||Wilcoxon signed rank test|||||||<0.0001
72505763|NCT01306058|144542693|NON_INFERIORITY|eos (end of study) vs. cycle 1 day 1. Paired T-test. Two tailed.||||||0.0009|||||||Wilcoxon signed rank test|||||||0.0009
72471362|NCT04148989|144466532|SUPERIORITY||Odds Ratio (OR)|1.03||||0.94|TWO_SIDED|95.0|0.49|2.17|||Regression, Logistic||Change in new-onset Clostridium difficile colitis risk associated with Code Sepsis implementation derived from adjusted differences-in-differences analysis.|Differences-in-differences analysis using multivariable logistic regression to estimate the change in outcome after versus before intervention implementation at the intervention site adjusted for the change observed at control sites and for subjects' age, sex, Elixhauser Comorbidity Score, ED arrival via ambulance, English language preference, temperature, systolic blood pressure, Acute Physiology Score, Sequential Organ Failure Assessment score, and ED-diagnosed source of infection.||2.17|0.49|0.94
72471363|NCT04148989|144466533|SUPERIORITY|Multiple imputation was employed to account for missing covariate data affecting 3.6% of eligible patients.|Odds Ratio (OR)|1.41||||0.1|TWO_SIDED|95.0|0.93|2.14|||Regression, Logistic||Change in new-onset Clostridium difficile colitis risk associated with Code Sepsis implementation derived from adjusted differences-in-differences analysis.|Differences-in-differences analysis using multivariable logistic regression to estimate the change in outcome after versus before intervention implementation at the intervention site adjusted for the change observed at control sites and for prespecified covariates.||2.14|0.93|0.10
72471364|NCT04148989|144466534|SUPERIORITY|Multiple imputation was employed to account for missing covariate data affecting 3.1% of eligible patients.|Odds Ratio (OR)|1.15||||0.59|TWO_SIDED|95.0|0.69|1.93|||Regression, Logistic||Change in risk for antimicrobial administration in the ED associated with Code Sepsis implementation derived from adjusted differences-in-differences analysis|Differences-in-differences analysis using multivariable logistic regression to estimate the change in outcome after versus before intervention implementation at the intervention site adjusted for the change observed at control sites and for prespecified covariates.||1.93|0.69|0.59
72471365|NCT04148989|144466535|SUPERIORITY||Mean Difference (Final Values)|0.32||||0.02|TWO_SIDED|95.0|0.06|0.58|||Regression, Linear||Change in total spectrum score of antibiotics administered within 24 hours of ED arrival associated with Code Sepsis implementation derived from adjusted differences-in-differences analysis|Differences-in-differences analysis using multivariable ??? regression to estimate the change in outcome after versus before intervention implementation at the intervention site adjusted for the change observed at control sites and for subjects' age, sex, Elixhauser Comorbidity Score, ED arrival via ambulance, English language preference, temperature, systolic blood pressure, Acute Physiology Score, Sequential Organ Failure Assessment score, and ED-diagnosed source of infection.||0.58|0.06|0.02
72471366|NCT04148989|144466536|SUPERIORITY|Multiple imputation was employed to account for missing covariate data affecting 2.0% of eligible patients.|Mean Difference (Final Values)|0.17||||0.02|TWO_SIDED|95.0|0.03|0.31|||Regression, Linear||Change in total spectrum score of antibiotics administered within 24 hours of ED arrival associated with Code Sepsis implementation derived from adjusted differences-in-differences analysis|Differences-in-differences analysis using multivariable linear regression to estimate the change in outcome after versus before intervention implementation at the intervention site adjusted for the change observed at control sites and for prespecified covariates.||0.31|0.03|0.02
72395671|NCT01774968|144297621|NON_INFERIORITY_OR_EQUIVALENCE|A non-inferiority margin of 0.4% was used.|LS Mean Difference|-0.1||||0.3709|TWO_SIDED|95.0|-0.33|0.12|||Mixed Models Analysis|||Approximately 325 participants were to be randomized (in a 1:1 ratio of U-500R insulin TID:BID) and 260 were to complete the study (with a 20% dropout rate). The 260 completers would provide a 66.4% chance to show equivalence of TID and BID algorithms, 14.4% chance to show noninferiority of TID, 2.5% chance to superiority of TID, 14.4% chance to show noninferiority of BID, and 2.5% chance to show superiority of BID, assuming a difference in HbA1c change of 0% and a standard deviation of 1.1%.||0.12|-0.33|0.3709
72471367|NCT00706654|144466541|NON_INFERIORITY_OR_EQUIVALENCE|The test of non-inferiority of was performed using a 95% confidence interval (CI, 2-sided) for the difference in the estimated percentage of patients meeting exacerbation of psychotic symptoms/impending relapse criteria by the end of Week 26. Non-inferiority was considered confirmed if the upper bound of the 2-sided 95% CI was below the predefined margin, 11.5%.|Mean Difference (Final Values)|-0.64||||0.7871|TWO_SIDED|95.0|-5.26|3.99|||z-statistics||The 95% CI of the difference in proportions of subjects with impending relapse events between aripiprazole IM depot 300 or 400 mg mg and oral aripiprazole were provided using the pooled SE with assumption of normality of the estimated difference.|Sample sizes were estimated to achieve 93% power for the primary non-inferiority 2-sided comparison at 0.05 significance using large sample normal approximations for the distribution of the difference in binomial proportions. The assumed proportion of impending relapse at or before Week 26 for the oral aripiprazole 10-30 mg arm was 18% and the predefined non-inferiority margin was 11.5%. The sample size was projected to be 260 each for the IM depot 300 or 400 mg and oral 10-30 mg arms.||3.99|-5.26|0.7871
72471368|NCT00706654|144466541|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.68||||0.0006|TWO_SIDED|95.0|-23.09|-6.27||Once non-inferiority was declared, superiority of depot 300/400 mg over depot 25/50 mg was tested by the difference between the proportion of subjects experiencing impending relapse by the end of Week 26 (2-sided 0.05 significance level z-statistic).|z-statistics|The same method was used to compare IM depot 300 or 400 mg with IM depot 25 or 50 mg in the estimated proportion of subjects with impending relapse.||For the superiority comparison (assay sensitivity analysis) of IM depot 300 or 400 mg to IM depot 25 or 50 mg, on a 2:1 randomization, sample sizes of 260 and 130, respectively, were calculated to provide about 95% power at the 0.05 significance level (2-sided). A superiority margin of 17% was assumed.||-6.27|-23.09|0.0006
72471369|NCT00706654|144466543|SUPERIORITY_OR_OTHER|||||||0.875||95.0|||||z-statistics|||||||0.8750
72471370|NCT00706654|144466543|SUPERIORITY_OR_OTHER|||||||0.0001||95.0|||||z-statistics|||||||0.0001
72471371|NCT00706654|144466544|SUPERIORITY_OR_OTHER|||||||0.37||95.0|||||z-statistics|||||||0.3700
72471372|NCT00706654|144466544|SUPERIORITY_OR_OTHER|||||||0.1097||95.0|||||z-statistics|||||||0.1097
72471373|NCT00594022|144466545|SUPERIORITY_OR_OTHER|||||||0.1275|||||||t-test, 1 sided|||||||.1275
72565623|NCT02709486|144662688|SUPERIORITY||Least Square Mean Difference|-0.32|STANDARD_ERROR_OF_MEAN|0.06|<|0.0001|TWO_SIDED|95.0|-0.43|-0.2|||ANCOVA|||Week 12: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline PGA of osteoarthritis and baseline diary average pain as covariates, and study site as a random effect.||-0.20|-0.43|<.0001
72471374|NCT01151215|144466552|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.16||||0.485|TWO_SIDED|95.0|0.77|1.75||Statistical significance threshold at this interim analysis was 5%|Log Rank|The log rank test was stratified for the IVRS stratification factor of disease classification (locally advanced / metastatic disease)|The Hazard Ratio is for AZD8931 40mg + anastrozole 1mg / Placebo + anastrozole 1mg, ie a hazard ratio \<1 favours AZD8931 40mg + anastrozole 1mg|345 patients were to be randomised to observe at least 233 progression events, based on HR=0.60, 90% power, 2-sided 5% significant level and a median of 9 months for the placebo arm. An interim analysis with futility boundary was introduced based on an IDMC recommendation.||1.75|0.77|0.485
72471375|NCT01151215|144466552|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.37||||0.135|TWO_SIDED|95.0|0.91|2.06|||Log Rank|The log rank test was stratified for the IVRS stratification factor of disease classification (locally advanced / metastatic disease)|The Hazard ratio is for AZD8931 20mg + anastrozole 1mg / Placebo + anastrozole 1mg, ie a hazard ratio \< 1 favours AZD8931 20mg + anastrozole 1mg|345 patients were to be randomised to observe at least 233 progression events, based on HR=0.6, 90% power, 2-sided 5% significant level and a median of 9 months for the placebo arm. An interim analysis with futility boundary was introduced based on an IDMC recommendation.||2.06|0.91|0.135
72471376|NCT03392168|144466554|SUPERIORITY||Least squares mean difference|-28.5||||0.0007|TWO_SIDED|95.0|-44.6|-12.4|||Mixed Models Analysis|||LS mean difference from vehicle; Estimates for LS means and accompanying 95% confidence intervals and P values are from a mixed model for repeated measures (MMRM) with center within country, treatment, study visit, and treatment-by-study visit interaction as fixed effects, and baseline value as a covariate.||-12.4|-44.6|0.0007
72471377|NCT03392168|144466554|SUPERIORITY||Least squares mean difference|-27.8||||0.0011|TWO_SIDED|95.0|-44.2|-11.5|||Mixed Models Analysis|||LS mean difference from vehicle; Estimates for LS means and accompanying 95% confidence intervals and P values are from a mixed model for repeated measures (MMRM) with center within country, treatment, study visit, and treatment-by-study visit interaction as fixed effects, and baseline value as a covariate.||-11.5|-44.2|0.0011
72471378|NCT03392168|144466555|SUPERIORITY||Least squares mean difference|-3.2||||0.5493|TWO_SIDED|95.0|-13.7|7.3|||Mixed Models Analysis|||At Week 1; LS mean difference from vehicle; Estimates for LS means and accompanying 95% confidence intervals and P values are from a mixed model for repeated measures (MMRM) with center within country, treatment, study visit, and treatment-by-study visit interaction as fixed effects, and baseline value as a covariate.||7.3|-13.7|0.5493
72471379|NCT03392168|144466555|SUPERIORITY||Least squares mean difference|-4.9||||0.365|TWO_SIDED|95.0|-15.7|5.9|||Mixed Models Analysis|||At week 1; LS mean difference from vehicle; Estimates for LS means and accompanying 95% confidence intervals and P values are from a mixed model for repeated measures (MMRM) with center within country, treatment, study visit, and treatment-by-study visit interaction as fixed effects, and baseline value as a covariate.||5.9|-15.7|0.3650
72505764|NCT01666444|144542695|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.22||||0.923|ONE_SIDED|92.0||1.48||P-value is for a one-sided hypothesis test.|Log Rank|The logrank test is stratified for platinum-free interval (\<= 6 months vs \> 6 months), and performance status (0 vs 1).|Treatment Hazard ratio for overall survival (PLD+VTX relative to PLD+placebo). Survival is measured from date of enrollment and randomization on the study until death from any cause, or date of last contact.|The null hypothesis is that the hazards of death are equal for both treatment groups. The primary assessment of this hypothesis was done with a stratified logrank test and the study was to be considered sufficiently mature to assess this hypothesis when at least 211 deaths had occurred among all individuals enrolled. Type I error was to be set to 0.08 for a one-sided test and the power for detecting a 30% reduction in the hazard (hazard ratio=0.70) due to VTX-2337 was 88.2%.||1.48||0.923
72505765|NCT01666444|144542696|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.21||||0.943|ONE_SIDED|98.0||1.56||P-value is for a one-sided hypothesis test.|Log Rank|The logrank test is stratified for platinum-free interval (\<= 6 months vs \> 6 months), and performance status (0 vs 1).||The null hypothesis is that the hazards of first progression or death are equal for both treatment groups. The primary assessment was to use a stratified logrank test and the study was to be considered sufficiently mature when survival is mature for analysis. Type I error was to be set to 0.02 for a one-sided test and the power for detecting a 31% reduction in the hazard (hazard ratio=0.69) due to VTX-2337 was expected to be approximately 83%.||1.56||0.943
72565624|NCT02709486|144662688|SUPERIORITY||Least Square Mean Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.06||0.0352|TWO_SIDED|95.0|-0.26|-0.01|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline PGA of osteoarthritis and baseline diary average pain as covariates, and study site as a random effect.||-0.01|-0.26|0.0352
72565625|NCT02709486|144662688|SUPERIORITY||Least Square Mean Difference|-0.25|STANDARD_ERROR_OF_MEAN|0.06|<|0.0001|TWO_SIDED|95.0|-0.37|-0.13|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline PGA of osteoarthritis and baseline diary average pain as covariates, and study site as a random effect.||-0.13|-0.37|<.0001
72565626|NCT02709486|144662690|SUPERIORITY||Odds Ratio (OR)|2.23|||<|0.0001|TWO_SIDED|95.0|1.59|3.14|||Regression, Logistic|||Week 2: Odds ratio and 95 percent (%) confidence interval (CI) estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.14|1.59|<.0001
72471380|NCT03392168|144466555|SUPERIORITY||Least squares mean difference|-18.3||||0.0064|TWO_SIDED|95.0|-31.3|-5.3|||Mixed Models Analysis|||At Week 2; LS mean difference from vehicle; Estimates for LS means and accompanying 95% confidence intervals and P values are from a mixed model for repeated measures (MMRM) with center within country, treatment, study visit, and treatment-by-study visit interaction as fixed effects, and baseline value as a covariate.||-5.3|-31.3|0.0064
72471381|NCT03392168|144466555|SUPERIORITY||Least squares mean difference|-19.8||||0.0039|TWO_SIDED|95.0|-33.0|-6.5|||Mixed Models Analysis|||At Week 2; LS mean difference from vehicle; Estimates for LS means and accompanying 95% confidence intervals and P values are from a mixed model for repeated measures (MMRM) with center within country, treatment, study visit, and treatment-by-study visit interaction as fixed effects, and baseline value as a covariate.||-6.5|-33.0|0.0039
72471382|NCT03392168|144466555|SUPERIORITY||Least squares mean difference|-28.9||||0.0001|TWO_SIDED|95.0|-42.9|-14.8|||Mixed Models Analysis|||At Week 3; LS mean difference from vehicle; Estimates for LS means and accompanying 95% confidence intervals and P values are from a mixed model for repeated measures (MMRM) with center within country, treatment, study visit, and treatment-by-study visit interaction as fixed effects, and baseline value as a covariate.||-14.8|-42.9|0.0001
72471383|NCT03392168|144466555|SUPERIORITY||Least squares mean difference|-23.0||||0.0019|TWO_SIDED|95.0|-37.3|-8.7|||Mixed Models Analysis|||At Week 3; LS mean difference from vehicle; Estimates for LS means and accompanying 95% confidence intervals and P values are from a mixed model for repeated measures (MMRM) with center within country, treatment, study visit, and treatment-by-study visit interaction as fixed effects, and baseline value as a covariate.||-8.7|-37.3|0.0019
72471384|NCT03392168|144466556|SUPERIORITY||Least squares mean difference|-4.3||||0.3626|TWO_SIDED|95.0|-13.6|5.0|||Mixed Models Analysis|||At Week 1; LS mean difference from vehicle; Estimates for LS means and accompanying 95% confidence intervals and P values are from a mixed model for repeated measures (MMRM) with center within country, treatment, study visit, and treatment-by-study visit interaction as fixed effects, and baseline value as a covariate.||5.0|-13.6|0.3626
72471385|NCT03392168|144466556|SUPERIORITY||Least squares mean difference|-8.1||||0.1011|TWO_SIDED|95.0|-17.8|1.6|||Mixed Models Analysis|||At Week 1; LS mean difference from vehicle; Estimates for LS means and accompanying 95% confidence intervals and P values are from a mixed model for repeated measures (MMRM) with center within country, treatment, study visit, and treatment-by-study visit interaction as fixed effects, and baseline value as a covariate.||1.6|-17.8|0.1011
72471386|NCT03392168|144466556|SUPERIORITY||Least squares mean difference|-15.5||||0.0017|TWO_SIDED|95.0|-25.1|-6.0|||Mixed Models Analysis|||At Week 2; LS mean difference from vehicle; Estimates for LS means and accompanying 95% confidence intervals and P values are from a mixed model for repeated measures (MMRM) with center within country, treatment, study visit, and treatment-by-study visit interaction as fixed effects, and baseline value as a covariate.||-6.0|-25.1|0.0017
72471387|NCT03392168|144466556|SUPERIORITY||Least squares mean difference|-19.3||||0.0002|TWO_SIDED|95.0|-29.1|-9.4|||Mixed Models Analysis|||At Week 2; LS mean difference from vehicle; Estimates for LS means and accompanying 95% confidence intervals and P values are from a mixed model for repeated measures (MMRM) with center within country, treatment, study visit, and treatment-by-study visit interaction as fixed effects, and baseline value as a covariate.||-9.4|-29.1|0.0002
72471388|NCT03392168|144466556|SUPERIORITY||Least squares mean difference|-21.3||||0.0003|TWO_SIDED|95.0|-32.4|-10.2|||Mixed Models Analysis|||At Week 3; LS mean difference from vehicle; Estimates for LS means and accompanying 95% confidence intervals and P values are from a mixed model for repeated measures (MMRM) with center within country, treatment, study visit, and treatment-by-study visit interaction as fixed effects, and baseline value as a covariate.||-10.2|-32.4|0.0003
72471389|NCT03392168|144466556|SUPERIORITY||Least squares mean difference|-21.8||||0.0003|TWO_SIDED|95.0|-33.2|-10.4|||Mixed Models Analysis|||At Week 3; LS mean difference from vehicle; Estimates for LS means and accompanying 95% confidence intervals and P values are from a mixed model for repeated measures (MMRM) with center within country, treatment, study visit, and treatment-by-study visit interaction as fixed effects, and baseline value as a covariate.||-10.4|-33.2|0.0003
72505766|NCT04011436|144542704|SUPERIORITY|In the bivariate analysis, a comparison was initially made of each of the domains of the Kujala test, for the assessment of pain at baseline, assessing the differences between the intervention groups using the chi-square or Fisher's exact tests. The Spearman correlation coefficient was used to evaluate the relationship between two continuous variables, such as Q angle and anterior knee pain, assessing the correlation marginally and conditionally on each of the treatment groups.|difference in frequency distribution|0.05|||<|0.05|TWO_SIDED|95.0|0.025|0.05|||Fisher Exact|we also used Chi-squared for the domains of pain and limp.||||0.05|0.025|<0.05
72505767|NCT04011436|144542705|SUPERIORITY|For the analysis of the differences in medians between the groups, taking into account that the outcomes did not present a normal distribution, and assuming the assumption of independence of the variables, the non-parametric Mann-Whitney U test was used.|Median Difference (Final Values)|0.058|||<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||"Estimated Value was done for the assessment of change in pain with Visual Analogue Scale.~The dispersion parameter that was calculated were interquartile ranges for the differences in medians between groups."|||||<0.05
72505768|NCT04011436|144542706|SUPERIORITY||Median Difference (Final Values)|0.75|||<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||"Estimated value was calculated for Change in Patellofemoral Misalignment With Q Angle´s Exam.~The dispersion parameter that was calculated were interquartile ranges for the differences in medians between groups."|||||<0.05
72505769|NCT04011436|144542707|SUPERIORITY||Median Difference (Final Values)|0.001|||<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||"Estimated Value was calculated for the change in core strength with McGill´s Exam.~The dispersion parameter that was calculated were interquartile ranges for the differences in medians between groups."|||||<0.05
72505770|NCT04011436|144542708|SUPERIORITY||Median Difference (Final Values)|0.67|||<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||"Estimated value was calculated for the change in Quadriceps and Gluteus Strength With Squat´s Test.~The dispersion parameter that was calculated were interquartile ranges for the differences in medians between groups."|||||<0.05
72565627|NCT02709486|144662690|SUPERIORITY||Odds Ratio (OR)|1.56||||0.0085|TWO_SIDED|95.0|1.12|2.18|||Regression, Logistic|||Week 2: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.18|1.12|0.0085
72471390|NCT03392168|144466556|SUPERIORITY||Least squares mean difference|-18.7||||0.001|TWO_SIDED|95.0|-29.5|-7.8|||Mixed Models Analysis|||At Week 4; LS mean difference from vehicle; Estimates for LS means and accompanying 95% confidence intervals and P values are from a mixed model for repeated measures (MMRM) with center within country, treatment, study visit, and treatment-by-study visit interaction as fixed effects, and baseline value as a covariate.||-7.8|-29.5|0.0010
72471391|NCT03392168|144466556|SUPERIORITY||Least squares mean difference|-21.8||||0.0002|TWO_SIDED|95.0|-32.9|-10.6|||Mixed Models Analysis|||At Week 4; LS mean difference from vehicle; Estimates for LS means and accompanying 95% confidence intervals and P values are from a mixed model for repeated measures (MMRM) with center within country, treatment, study visit, and treatment-by-study visit interaction as fixed effects, and baseline value as a covariate.||-10.6|-32.9|0.0002
72471392|NCT03392168|144466557|SUPERIORITY||Least squares mean difference|2.67||||0.3209|TWO_SIDED|95.0|-2.65|7.99|||Mixed Models Analysis|||At Week 1; LS mean difference from vehicle; Estimates for LS means and accompanying 95% confidence intervals and P values are from a mixed model for repeated measures (MMRM) with center within country, treatment, study visit, and treatment-by-study visit interaction as fixed effects, and baseline value as a covariate.||7.99|-2.65|0.3209
72471393|NCT03392168|144466557|SUPERIORITY||Least squares mean difference|3.6||||0.1947|TWO_SIDED|95.0|-1.88|9.08|||Mixed Models Analysis|||At Week 1; LS mean difference from vehicle; Estimates for LS means and accompanying 95% confidence intervals and P values are from a mixed model for repeated measures (MMRM) with center within country, treatment, study visit, and treatment-by-study visit interaction as fixed effects, and baseline value as a covariate.||9.08|-1.88|0.1947
72471394|NCT03392168|144466557|SUPERIORITY||Least squares mean difference|-4.58||||0.3561|TWO_SIDED|95.0|-14.4|5.24|||Mixed Models Analysis|||At Week 2; LS mean difference from vehicle; Estimates for LS means and accompanying 95% confidence intervals and P values are from a mixed model for repeated measures (MMRM) with center within country, treatment, study visit, and treatment-by-study visit interaction as fixed effects, and baseline value as a covariate.||5.24|-14.40|0.3561
72505771|NCT04011436|144542709|SUPERIORITY||Median Difference (Final Values)|0.55|||<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||||"Estimated value was calculated for the change in Static Balance with Single Leg Stance.~The dispersion parameter that was calculated were interquartile ranges for the differences in medians between groups."|||<0.05
72471395|NCT03392168|144466557|SUPERIORITY||Least squares mean difference|-5.82||||0.249|TWO_SIDED|95.0|-15.79|4.16|||Mixed Models Analysis|||At Week 2; LS mean difference from vehicle; Estimates for LS means and accompanying 95% confidence intervals and P values are from a mixed model for repeated measures (MMRM) with center within country, treatment, study visit, and treatment-by-study visit interaction as fixed effects, and baseline value as a covariate.||4.16|-15.79|0.2490
72471396|NCT03392168|144466557|SUPERIORITY||Least squares mean difference|-12.68||||0.0276|TWO_SIDED|95.0|-23.992|-1.44|||Mixed Models Analysis|||At Week 3; LS mean difference from vehicle; Estimates for LS means and accompanying 95% confidence intervals and P values are from a mixed model for repeated measures (MMRM) with center within country, treatment, study visit, and treatment-by-study visit interaction as fixed effects, and baseline value as a covariate.||-1.44|-23.992|0.0276
72471397|NCT03392168|144466557|SUPERIORITY||Least squares mean difference|-7.04||||0.2223|TWO_SIDED|95.0|-18.44|4.36|||Mixed Models Analysis|||At Week 3; LS mean difference from vehicle; Estimates for LS means and accompanying 95% confidence intervals and P values are from a mixed model for repeated measures (MMRM) with center within country, treatment, study visit, and treatment-by-study visit interaction as fixed effects, and baseline value as a covariate.||4.36|-18.44|0.2223
72471398|NCT03392168|144466557|SUPERIORITY||Least squares mean difference|-20.27||||0.0108|TWO_SIDED|95.0|-35.72|-4.82|||Mixed Models Analysis|||At Week 4; LS mean difference from vehicle; Estimates for LS means and accompanying 95% confidence intervals and P values are from a mixed model for repeated measures (MMRM) with center within country, treatment, study visit, and treatment-by-study visit interaction as fixed effects, and baseline value as a covariate.||-4.82|-35.72|0.0108
72471399|NCT03392168|144466557|SUPERIORITY||Least squares mean difference|-16.67||||0.0372|TWO_SIDED|95.0|-32.34|-1.01|||Mixed Models Analysis|||At Week 4; LS mean difference from vehicle; Estimates for LS means and accompanying 95% confidence intervals and P values are from a mixed model for repeated measures (MMRM) with center within country, treatment, study visit, and treatment-by-study visit interaction as fixed effects, and baseline value as a covariate.||-1.01|-32.34|0.0372
72505772|NCT04011436|144542710|SUPERIORITY||Median Difference (Final Values)|0.492|||<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||||"Estimated value was calculated for the change in the total amount of Physical Activity reported in minutes.~The dispersion parameter that was calculated were interquartile ranges for the differences in medians between groups."|||<0.05
72505773|NCT00474630|144542745|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.28|||<|0.001||95.0|-4.34|-2.22|||ANCOVA|||||-2.22|-4.34|<0.001
72471400|NCT01721954|144466558|SUPERIORITY||Hazard Ratio (HR)|0.93||||0.43|TWO_SIDED|95.0|||||Log Rank|||The null hypothesis tested for the primary efficacy endpoint is overall survival (months) of SIRT/FOLFOX treatment versus FOLFOX is equal for both groups. The two-sided alternative hypothesis tested with 95% confidence is OS time for SIRT/FOLFOX treatment lower to that of FOLFOX.||||0.43
72505774|NCT00474630|144542746|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.49|||<|0.001|TWO_SIDED|95.0|-0.71|-0.27|||ANCOVA|||||-0.27|-0.71|<0.001
72505775|NCT00474630|144542747|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.44|||<|0.001|TWO_SIDED|95.0|2.15|5.5|||Regression, Logistic|||||5.50|2.15|<0.001
72505776|NCT00474630|144542748|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-10.4||||0.007|TWO_SIDED||||||ANCOVA|||||||0.007
72505777|NCT00474630|144542749|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.32|||<|0.001|TWO_SIDED|95.0|1.8|4.84|||ANCOVA|||||4.84|1.80|<0.001
72505778|NCT00474630|144542750|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-7.85||||0.065|TWO_SIDED|95.0|-16.21|0.5|||ANCOVA|||||0.50|-16.21|0.065
72505779|NCT00474630|144542751|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.08|||||TWO_SIDED|95.0|-3.57|-0.59||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||-0.59|-3.57|
72576698|NCT01191944|144680201|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.031|STANDARD_ERROR_OF_MEAN|0.0798||0.6995|TWO_SIDED|95.0|-0.127|0.188|||ANCOVA|||||0.188|-0.127|0.6995
72576699|NCT01191944|144680202|SUPERIORITY_OR_OTHER|||||||0.317||95.0|||||Cochran-Mantel-Haenszel|||||||0.3170
72576700|NCT01191944|144680203|SUPERIORITY_OR_OTHER|||||||0.4756||95.0|||||Cochran-Mantel-Haenszel|||||||0.4756
72576701|NCT01191944|144680204|SUPERIORITY_OR_OTHER|||||||0.1051||95.0|||||Cochran-Mantel-Haenszel|||||||0.1051
72576702|NCT01191944|144680205|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.154|STANDARD_ERROR_OF_MEAN|0.3138||0.6237|TWO_SIDED|95.0|-0.463|0.771|||ANCOVA|||||0.771|-0.463|0.6237
72576703|NCT01191944|144680207|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.628|STANDARD_ERROR_OF_MEAN|0.7088||0.376|TWO_SIDED|95.0|-0.765|2.021|||ANCOVA|||||2.021|-0.765|0.3760
72505780|NCT00474630|144542752|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.75|||||TWO_SIDED|95.0|1.79|7.88||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||7.88|1.79|
72505781|NCT00474630|144542753|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.46|||||TWO_SIDED|95.0|1.5|4.04||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||4.04|1.50|
72505782|NCT00474630|144542754|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.55|||||TWO_SIDED|95.0|0.35|0.86||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||0.86|0.35|
72505783|NCT00474630|144542755|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.43|||||TWO_SIDED|95.0|0.27|7.57||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||7.57|0.27|
72505784|NCT00474630|144542756|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.63|||||TWO_SIDED|95.0|0.55|12.67||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||12.67|0.55|
72505785|NCT00474630|144542757|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.89|||||TWO_SIDED|||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||
72505786|NCT00474630|144542758|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.13|||||TWO_SIDED|||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||
72505787|NCT00474630|144542759|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.64|||||TWO_SIDED|95.0|1.36|5.14||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||5.14|1.36|
72505788|NCT00474630|144542760|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.37|||||TWO_SIDED|95.0|-0.77|3.51||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||3.51|-0.77|
72565628|NCT02709486|144662690|SUPERIORITY||Odds Ratio (OR)|2.71|||<|0.0001|TWO_SIDED|95.0|1.89|3.88|||Regression, Logistic|||Week 4: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.88|1.89|<.0001
72471401|NCT01721954|144466559|SUPERIORITY||Hazard Ratio (HR)|0.75|||<|0.05|TWO_SIDED||||||Log Rank|||A sample size of at least 209 patients for the SIRFLOX study was estimated to be needed to detect an increase in the median PFS at any site from 9.4 months to 14.5 months with 80% power and 95% confidence. Taking into account the number of patients who might receive the alternative treatment or lack of imaging data, the sample size was increased to 209. The Null hypothesis is no difference between the treatment arms with respect to PFS.||||<0.05
72505789|NCT00474630|144542761|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-7.62|||||TWO_SIDED|||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||
72505790|NCT00474630|144542763|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.98|||||TWO_SIDED|95.0|-9.22|-0.74||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||-0.74|-9.22|
72505791|NCT00474630|144542764|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.43|||||TWO_SIDED|95.0|-7.48|4.62||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||4.62|-7.48|
72505792|NCT00474630|144542765|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.16|||||TWO_SIDED|95.0|-1.02|3.33||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||3.33|-1.02|
72505793|NCT00474630|144542766|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.41|||||TWO_SIDED|95.0|-1.04|1.86||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||1.86|-1.04|
72505794|NCT00474630|144542767|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.62|||||TWO_SIDED|95.0|0.59|2.65||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||2.65|0.59|
72565629|NCT02709486|144662690|SUPERIORITY||Odds Ratio (OR)|2.31|||<|0.0001|TWO_SIDED|95.0|1.62|3.28|||Regression, Logistic|||Week 4: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.28|1.62|<.0001
72471402|NCT02358668|144466604|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.46||||0.57|TWO_SIDED|95.0|-6.28|11.2||The p-value of treatment effects relative to placebo was obtained by ANCOVA analysis comparing the outcome values adjusted for age, gender and baseline measurements.|ANCOVA|||||11.20|-6.28|0.57
72471403|NCT02358668|144466604|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.57||||0.72|TWO_SIDED|95.0|-10.3|7.11||The p-value of treatment effects relative to placebo was obtained by ANCOVA analysis comparing the outcome values adjusted for age, gender and baseline measurements.|ANCOVA|||||7.11|-10.3|0.72
72471404|NCT02358668|144466605|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.25||||0.66|TWO_SIDED|95.0|-0.91|1.42||The p-value of treatment effects relative to placebo was obtained by ANCOVA analysis comparing the outcome values adjusted for age, gender and baseline measurements.|ANCOVA|||||1.42|-0.91|0.66
72471405|NCT02358668|144466605|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.07||||0.9|TWO_SIDED|95.0|-1.03|1.18||The p-value of treatment effects relative to placebo was obtained by ANCOVA analysis comparing the outcome values adjusted for age, gender and baseline measurements.|ANCOVA|||||1.18|-1.03|0.90
72395672|NCT02044393|144297636|NON_INFERIORITY_OR_EQUIVALENCE|"90% confidence interval for gMean ratio of IT+BI 691751 to BI 69175 treatment was provided.~The ANOVA model included the fixed effects 'sequence', 'period' and 'treatment' and as a random effect 'subject within sequence' as source of variation."|gMean ratio|74.07|STANDARD_ERROR_OF_MEAN|32.1|||TWO_SIDED|90.0|62.371|87.959|||||"ratio of IT+BI 691751 to BI 691751 treatment. Estimated value and its confidence interval (CI) are in percentage unit.~The standard error of the mean actually is the geometric coefficient of variance."|gMean ratio of IT+BI 691751 to BI 69175 treatment (in plasma)||87.959|62.371|
72395673|NCT02044393|144297636|NON_INFERIORITY_OR_EQUIVALENCE|"90% confidence interval for gMean ratio of IT+BI 691751 to BI 69175 treatment was provided.~The ANOVA model included the fixed effects 'sequence', 'period' and 'treatment' and as a random effect 'subject within sequence' as source of variation."|gMean ratio|86.35|STANDARD_ERROR_OF_MEAN|18.6|||TWO_SIDED|90.0|78.04|95.56|||||"ratio of IT+BI 691751 to BI 691751 treatment. Estimated value and its confidence interval (CI) are in percentage unit.~The standard error of the mean actually is the geometric coefficient of variance."|gMean ratio of IT+BI 691751 to BI 691751 treatment (in whole blood)||95.56|78.04|
72471406|NCT02358668|144466606|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.05||||0.86|TWO_SIDED|95.0|-0.5|0.59||The p-value of treatment effects relative to placebo was obtained by ANCOVA analysis comparing the outcome values adjusted for age, gender and baseline measurements.|ANCOVA|||||0.59|-0.50|0.86
72576704|NCT00603837|144680210|SUPERIORITY_OR_OTHER|||||||0.445||95.0|||||t-test, 1 sided|||||||0.445
72576705|NCT03578549|144680226|OTHER||Correlation Coefficient|0.01||||0.92|TWO_SIDED||||||ANOVA|||||||0.92
72576706|NCT01851330|144680237|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||The p-value for the comparison of the LDV/SOF 8 week group against the adjusted historical null rate (60%) was based on a 2-sided 1-sample binomial test.|Binomial test|||||||<0.001
72576707|NCT01851330|144680237|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||The p-value for the comparison of the LDV/SOF+RBV 8 week group against the adjusted historical null rate (60%) was based on a 2-sided 1-sample binomial test.|Binomial test|||||||<0.001
72576708|NCT01851330|144680237|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||The p-value for the comparison of the LDV/SOF 12 week group against the adjusted historical null rate (60%) was based on a 2-sided 1-sample binomial test.|Binomial test|||||||<0.001
72576709|NCT01851330|144680237|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority would be demonstrated if the lower bound of the confidence interval (CI) for the difference between groups was greater than -12%.|Difference in proportions|-3.2|||||TWO_SIDED|97.5|-8.3|1.8|||||Difference in proportions between treatment groups and associated confidence interval (CI) were calculated based on stratum-adjusted Mantel-Haenszel proportions.|||1.8|-8.3|
72576710|NCT01851330|144680237|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority would be demonstrated if the lower bound of the CI for the difference between groups was greater than -12%.|Difference in proportions|-2.3|||||TWO_SIDED|97.5|-7.2|2.5|||||Difference in proportions between treatment groups and associated confidence interval (CI) were calculated based on stratum-adjusted Mantel-Haenszel proportions.|||2.5|-7.2|
72576711|NCT01851330|144680237|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority would be demonstrated if the lower bound of the CI for the difference between groups was greater than -12%.|Difference in proportions|0.9|||||TWO_SIDED|95.0|-3.9|5.7|||||Difference in proportions between treatment groups and associated confidence interval (CI) were calculated based on stratum-adjusted Mantel-Haenszel proportions.|||5.7|-3.9|
72576712|NCT02667067|144680255|SUPERIORITY||||||<|0.001|||||||t-test, 1 sided|||||||<.001
72576713|NCT02368314|144680271|SUPERIORITY_OR_OTHER|||||||0.226|||||||Fisher Exact|||||||0.226
72576714|NCT01333397|144680312|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||Chi-squared|||ILA - Dysport NG 20 U Vs Placebo||||<0.0001
72576715|NCT01333397|144680312|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||Chi-squared|||ILA - Dysport NG 50 U Vs Placebo||||<0.0001
72576716|NCT01333397|144680312|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||Chi-squared|||ILA - Dysport NG 75 U Vs Placebo||||<0.0001
72576717|NCT01333397|144680312|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||Chi-squared|||SSA - Dysport NG 20 U Vs Placebo||||<0.0001
72576718|NCT01333397|144680312|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||Chi-squared|||SSA - Dysport NG 50 U Vs Placebo||||<0.0001
72576719|NCT01333397|144680312|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||Chi-squared|||SSA - Dysport NG 75 U Vs Placebo||||<0.0001
72576720|NCT02728843|144680406|SUPERIORITY||||||>|0.05|||||||ANCOVA|||||||>0.05
72576721|NCT02728843|144680407|SUPERIORITY||||||>|0.05|||||||ANCOVA|||||||>0.05
72576722|NCT02728843|144680408|SUPERIORITY||||||>|0.05|||||||ANCOVA|||||||>0.05
72576723|NCT02728843|144680409|SUPERIORITY||||||>|0.05|||||||ANCOVA|||||||>0.05
72576724|NCT02728843|144680410|SUPERIORITY||||||>|0.05|||||||ANCOVA|||||||>0.05
72576725|NCT02728843|144680411|SUPERIORITY||||||>|0.05|||||||ANCOVA|||||||>0.05
72576726|NCT02728843|144680412|SUPERIORITY||||||>|0.05|||||||ANCOVA|||||||>0.05
72576727|NCT00351533|144680422|SUPERIORITY_OR_OTHER|||||||0.37||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.37
72576728|NCT00351533|144680423|SUPERIORITY_OR_OTHER|||||||0.04||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.04
72576729|NCT00351533|144680424|SUPERIORITY_OR_OTHER|||||||0.16||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.16
72576730|NCT00351533|144680425|SUPERIORITY_OR_OTHER|||||||0.79||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.79
72576731|NCT00351533|144680426|SUPERIORITY_OR_OTHER|||||||0.34||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.34
72576732|NCT00351533|144680427|SUPERIORITY_OR_OTHER|||||||0.26||95.0|||||t-test, 2 sided|||||||0.26
72576733|NCT00351533|144680428|SUPERIORITY_OR_OTHER|||||||0.06||95.0|||||t-test, 2 sided|||||||0.06
72576734|NCT00351533|144680429|SUPERIORITY_OR_OTHER|||||||0.89||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.89
72576735|NCT00351533|144680430|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.002
72576736|NCT00351533|144680431|SUPERIORITY_OR_OTHER|||||||0.27||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.27
72576737|NCT00351533|144680432|SUPERIORITY_OR_OTHER|||||||0.2||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.20
72576738|NCT00351533|144680433|SUPERIORITY_OR_OTHER|||||||0.11||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.11
72576739|NCT00351533|144680434|SUPERIORITY_OR_OTHER|||||||0.56||95.0|||||t-test, 2 sided|||||||0.56
72395674|NCT02044393|144297637|NON_INFERIORITY_OR_EQUIVALENCE|"90% confidence interval for gMean ratio of IT+BI 691751 to BI 69175 treatment was provided.~The ANOVA model included the fixed effects 'sequence', 'period' and 'treatment' and as a random effect 'subject within sequence' as source of variation."|gMean ratio|95.59|STANDARD_ERROR_OF_MEAN|23.5|||TWO_SIDED|90.0|84.195|108.537|||||ratio of test to reference treatment. The standard error of the mean actually is the geometric coefficient of variance.|gMean ratio of test to reference treatment (in plasma)||108.537|84.195|
72395675|NCT02044393|144297637|NON_INFERIORITY_OR_EQUIVALENCE|"90% confidence interval for gMean ratio of IT+BI 691751 to BI 69175 treatment was provided.~The ANOVA model included the fixed effects 'sequence', 'period' and 'treatment' and as a random effect 'subject within sequence' as source of variation."|gMean ratio|93.54|STANDARD_ERROR_OF_MEAN|15.1|||TWO_SIDED|90.0|86.142|101.57|||||ratio of test to reference treatment. The standard error of the mean actually is the geometric coefficient of variance.|gMean ratio of test to reference treatment (in whole blood)||101.570|86.142|
72395676|NCT02044393|144297638|NON_INFERIORITY_OR_EQUIVALENCE|"90% confidence interval for gMean ratio of IT+BI 691751 to BI 69175 treatment was provided.~The ANOVA model included the fixed effects 'sequence', 'period' and 'treatment' and as a random effect 'subject within sequence' as source of variation."|gMean ratio|74.86|STANDARD_ERROR_OF_MEAN|32.4|||TWO_SIDED|90.0|62.946|89.035|||||ratio of IT+BI 691751 to BI 691751 treatment. The standard error of the mean actually is the geometric coefficient of variance.|gMean ratio of IT+BI 691751 to BI 691751 treatment (in plasma)||89.035|62.946|
72395677|NCT02044393|144297638|NON_INFERIORITY_OR_EQUIVALENCE|"90% confidence interval for gMean ratio of IT+BI 691751 to BI 69175 treatment was provided.~The ANOVA model included the fixed effects 'sequence', 'period' and 'treatment' and as a random effect 'subject within sequence' as source of variation."|gMean ratio|88.19|STANDARD_ERROR_OF_MEAN|20.7|||TWO_SIDED|90.0|78.6|98.95|||||ratio of IT+BI 691751 to BI 691751 treatment. The standard error of the mean actually is the geometric coefficient of variance.|gMean ratio of IT+BI 691751 to BI 691751 treatment (in whole blood)||98.95|78.60|
72505795|NCT00474630|144542768|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.43|||||TWO_SIDED|95.0|-0.42|1.27||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||1.27|-0.42|
72505796|NCT00474630|144542769|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.04|||||TWO_SIDED|96.0|-0.76|0.85||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||0.85|-0.76|
72505797|NCT03088605|144542780|SUPERIORITY||Mean Difference (Net)|-0.3||||0.02|TWO_SIDED|90.0|-0.7|0.0|||ANCOVA|||Change from Baseline. ANCOVA model includes baseline scores as a covariate||0|-0.7|0.02
72505798|NCT03088605|144542781|SUPERIORITY||Mean Difference (Net)|-1.0||||0.0001|TWO_SIDED|90.0|-1.4|0.5|||ANCOVA|||Change form baseline. ANCOVA model includes baseline score as a covariate.||0.5|-1.4|0.0001
72505799|NCT03088605|144542782|SUPERIORITY||Mean Difference (Net)|-1.42||||0.03|TWO_SIDED|90.0|-2.36|-0.47|||ANCOVA|||Change from baseline. ANCOVA model includes baseline score as a covariate.||-0.47|-2.36|0.03
72505800|NCT03088605|144542783|SUPERIORITY||Mean Difference (Net)|0.199||||0.39|TWO_SIDED|90.0|-0.177|0.575|||ANCOVA|||Change from Baseline; ANCOVA model includes baseline score as a covariate.||0.575|-0.177|0.39
72505801|NCT03088605|144542784|SUPERIORITY||Mean Difference (Net)|0.2||||0.97|TWO_SIDED|90.0|-1.7|2.0|||ANCOVA|||Change from baseline. ANCOVA model includes baseline score as a covariate.||2.0|-1.7|0.97
72505802|NCT03088605|144542785|SUPERIORITY||Mean Difference (Net)|-0.23||||0.06|TWO_SIDED|90.0|-0.48|0.03|||ANCOVA|||Change from baseline. ANCOVA model includes baseline score as a covariate.||0.03|-0.48|0.06
72395678|NCT02345850|144297647|SUPERIORITY||Hazard Ratio (HR)|0.805||||0.2368|TWO_SIDED|95.0|0.562|1.154||The primary pairwise comparisons are tested at a Bonferroni adjusted significance level of 0.05/3.|Log Rank|||The primary null hypothesis of the study is that there is no difference of the CRFS hazard ratio between CD34 select graft vs. Tac/MTX Control. The data in primary outcome table provides point estimates at specific time points (1 year and 2 years post randomization). The statistics in this session provides comparisons between different arms for the entire period of the study.||1.154|0.562|0.2368
72471407|NCT02358668|144466606|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.14||||0.59|TWO_SIDED|95.0|-0.66|0.38||The p-value of treatment effects relative to placebo was obtained by ANCOVA analysis comparing the outcome values adjusted for age, gender and baseline measurements.|ANCOVA|||||0.38|-0.66|0.59
72471408|NCT02358668|144466607|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.15||||0.62|TWO_SIDED|95.0|-0.44|0.73||The p-value of treatment effects relative to placebo was obtained by ANCOVA analysis comparing the outcome values adjusted for age, gender and baseline measurements.|ANCOVA|||||0.73|-0.44|0.62
72505803|NCT00958568|144542791|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.|Log Rank|||Power estimate assumes approximately 1230 participants enter SPII. With a 60% drop-out/disqualification rate in SPII, then 492 participants enter SPIII. If 26% of participants drop out during SPIII, then 364 participants enter SPIV. Assuming 20% drop-out rate, 25% relapse rate on OFC and 40% relapse rate for fluoxetine (hazard ratio = 0.56), the log-rank test is 80% powered to detect a difference at a 2-sided 0.05 level. A total of 95 relapse events during SPIV should satisfy these assumptions.||||<0.001
72505804|NCT00958568|144542792|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.|Cochran-Mantel-Haenszel|Relapse rates were analyzed using the Cochran-Mantel-Haenszel test adjusting for country.||||||<0.001
72505805|NCT00958568|144542793|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.|Cochran-Mantel-Haenszel|Relapse rates were analyzed using the Cochran-Mantel-Haenszel test adjusting for country.||||||<0.001
72505806|NCT00958568|144542794|SUPERIORITY_OR_OTHER|||||||0.713||95.0||||The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.|Cochran-Mantel-Haenszel|Relapse rates were analyzed using the Cochran-Mantel-Haenszel test adjusting for country.||||||0.713
72505807|NCT00958568|144542795|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.|Cochran-Mantel-Haenszel|Relapse rates were analyzed using the Cochran-Mantel-Haenszel test adjusting for country.||||||<0.001
72471409|NCT02358668|144466607|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.01||||0.97|TWO_SIDED|95.0|-0.52|0.55||The p-value of treatment effects relative to placebo was obtained by ANCOVA analysis comparing the outcome values adjusted for age, gender and baseline measurements.|ANCOVA|||||0.55|-0.52|0.97
72471410|NCT02358668|144466608|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.15||||0.4|TWO_SIDED|95.0|-0.2|0.51||The p-value of treatment effects relative to placebo was obtained by ANCOVA analysis comparing the outcome values adjusted for age, gender and baseline measurements.|ANCOVA|||||0.51|-0.20|0.40
72471411|NCT02358668|144466608|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.11||||0.49|TWO_SIDED|95.0|-0.21|0.44||The p-value of treatment effects relative to placebo was obtained by ANCOVA analysis comparing the outcome values adjusted for age, gender and baseline measurements.|ANCOVA|||||0.44|-0.21|0.49
72471412|NCT02358668|144466609|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.84||||0.41|TWO_SIDED|95.0|-2.88|1.21||The p-value of treatment effects relative to placebo was obtained by ANCOVA analysis comparing the outcome values adjusted for age, gender and baseline measurements.|ANCOVA|||||1.21|-2.88|0.41
72471413|NCT02358668|144466609|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.34||||0.15|TWO_SIDED|95.0|-3.18|0.51||The p-value of treatment effects relative to placebo was obtained by ANCOVA analysis comparing the outcome values adjusted for age, gender and baseline measurements.|ANCOVA|||||0.51|-3.18|0.15
72471414|NCT02358668|144466610|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.05||||0.64|TWO_SIDED|95.0|-0.29|0.18||The p-value of treatment effects relative to placebo was obtained by ANCOVA analysis comparing the outcome values adjusted for age, gender and baseline measurements.|ANCOVA|||||0.18|-0.29|0.64
72505808|NCT00958568|144542796|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.|Log Rank|||||||<0.001
72505809|NCT00958568|144542797|SUPERIORITY_OR_OTHER|||||||0.831||95.0||||The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.|Log Rank|||||||0.831
72505810|NCT00958568|144542798|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.|Log Rank|||||||<0.001
72505811|NCT00958568|144542802|SUPERIORITY_OR_OTHER|||||||0.047||95.0||||The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.|Cochran-Mantel-Haenszel|Remission rates were analyzed using the Cochran-Mantel-Haenszel test adjusting for country.||||||0.047
72505812|NCT00958568|144542803|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.91|STANDARD_ERROR_OF_MEAN|0.78|<|0.001|TWO_SIDED|95.0|-4.46|-1.36||The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.|t-test, 2 sided|The model adjusted for baseline (Week 20), treatment, country, visit, and treatment-by-visit interaction.||||-1.36|-4.46|<0.001
72565630|NCT02709486|144662690|SUPERIORITY||Odds Ratio (OR)|1.91||||0.0005|TWO_SIDED|95.0|1.33|2.75|||Regression, Logistic|||Week 8: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.75|1.33|0.0005
72471415|NCT02358668|144466610|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.09||||0.41|TWO_SIDED|95.0|-0.3|0.12||The p-value of treatment effects relative to placebo was obtained by ANCOVA analysis comparing the outcome values adjusted for age, gender and baseline measurements.|ANCOVA|||||0.12|-0.30|0.41
72471416|NCT02358668|144466611|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.19||||0.46|TWO_SIDED|95.0|-4.43|2.05||The p-value of treatment effects relative to placebo was obtained by ANCOVA analysis comparing the outcome values adjusted for age, gender and baseline measurements.|ANCOVA|||||2.05|-4.43|0.46
72471417|NCT02358668|144466611|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.75||||0.24|TWO_SIDED|95.0|-4.72|1.21||The p-value of treatment effects relative to placebo was obtained by ANCOVA analysis comparing the outcome values adjusted for age, gender and baseline measurements.|ANCOVA|||||1.21|-4.72|0.24
72471418|NCT02358668|144466612|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.01||||0.83|TWO_SIDED|95.0|-0.13|0.1||The p-value of treatment effects relative to placebo was obtained by ANCOVA analysis comparing the outcome values adjusted for age, gender and baseline measurements.|ANCOVA|||||0.10|-0.13|0.83
72471419|NCT02358668|144466612|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.04||||0.48|TWO_SIDED|95.0|-0.16|0.08||The p-value of treatment effects relative to placebo was obtained by ANCOVA analysis comparing the outcome values adjusted for age, gender and baseline measurements.|ANCOVA|||||0.08|-0.16|0.48
72471420|NCT02358668|144466613|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.14||||0.83|TWO_SIDED|95.0|-9.17|11.45||The p-value of treatment effects relative to placebo was obtained by ANCOVA analysis comparing the outcome values adjusted for age, gender and baseline measurements.|ANCOVA|||||11.45|-9.17|0.83
72471421|NCT02358668|144466613|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.92||||0.86|TWO_SIDED|95.0|-11.1|9.27||The p-value of treatment effects relative to placebo was obtained by ANCOVA analysis comparing the outcome values adjusted for age, gender and baseline measurements.|ANCOVA|||||9.27|-11.1|0.86
72471422|NCT02358668|144466614|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-13.6||||0.75|TWO_SIDED|95.0|-99.6|72.3||The p-value of treatment effects relative to placebo was obtained by ANCOVA analysis comparing the outcome values adjusted for age, gender and baseline measurements.|ANCOVA|||||72.3|-99.6|0.75
72505813|NCT00958568|144542804|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.82|||<|0.001|TWO_SIDED|95.0|-5.39|-2.24||The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.|t-test, 2 sided|The model adjusted for baseline (Week 20), treatment and country.||||-2.24|-5.39|<0.001
72505814|NCT00958568|144542805|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.34|STANDARD_ERROR_OF_MEAN|0.11||0.002|TWO_SIDED|95.0|-0.55|-0.12||The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.|t-test, 2 sided|The model adjusted for baseline (Week 20), treatment, country, visit, and treatment-by-visit interaction.||||-0.12|-0.55|0.002
72505815|NCT00958568|144542808|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.94|STANDARD_ERROR_OF_MEAN|0.72||0.007|TWO_SIDED|95.0|-3.36|-0.53||The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.|t-test, 2 sided|The model adjusted for baseline (Week 20), treatment and country.||||-0.53|-3.36|0.007
72395679|NCT02345850|144297647|SUPERIORITY||Hazard Ratio (HR)|0.864||||0.4134|TWO_SIDED|95.0|0.609|1.228||The primary pairwise comparisons are tested at a Bonferroni adjusted significance level of 0.05/3.|Log Rank|||The primary null hypothesis of the study is that there is no difference of the CRFS hazard ratio between Post-Transplant Cyclophosphamide vs. Tac/MTX Control. The data in primary outcome table provides point estimates. The statistics in this session provides comparisons between different arms for the entire period of the study.||1.228|0.609|0.4134
72395680|NCT02345850|144297647|SUPERIORITY||Hazard Ratio (HR)|0.933||||0.7166|TWO_SIDED|95.0|0.643|1.355||The primary pairwise comparisons are tested at a Bonferroni adjusted significance level of 0.05/3.|Log Rank|||The primary null hypothesis of the study is that there is no difference of the CRFS hazard ratio between CD34 select graft vs. Post-Transplant Cyclophosphamide. The data in primary outcome table provides point estimates. The statistics in this session provides comparisons between different arms for the entire period of the study.||1.355|0.643|0.7166
72395681|NCT02345850|144297647|SUPERIORITY|||||||0.386||||||Statistical significance was determined using a pre-specified threshold of 0.05.|Regression, Cox|||The null hypothesis is that there is no difference of the CRFS hazard ratio between treatment groups after adjustment for age, donor type, performance status, primary disease, and disease risk. The data in primary outcome table provides point estimates. The statistics in this session provides comparisons between different arms for the entire period of the study.||||0.386
72395682|NCT02345850|144297647|SUPERIORITY|||||||0.461||||||A Bonferroni adjusted significance level of 0.05/3=0.0167 is used for each of three interaction tests to account for multiple testing.|Cox proportional hazards regression|||Subgroup analyses are conducted for CRFS according to disease, disease risk and age. Interaction tests between treatment group and subgroup are conducted within a Cox proportional hazards regression model with treatment, subgroup, and a treatment\*subgroup interaction term. The null hypothesis is that there is no Interaction between treatment group and disease risk (Low/Intermediate vs. High) for CRFS.||||0.461
72395683|NCT02345850|144297647|SUPERIORITY|||||||0.115||||||Cox proportional hazards regression|Cox proportional hazards regression|||Subgroup analyses are conducted for CRFS according to disease, disease risk and age. Interaction tests between treatment group and subgroup are conducted within a Cox proportional hazards regression model with treatment, subgroup, and a treatment\*subgroup interaction term. The null hypothesis is that there is no Interaction between treatment group and Age (\<=50 vs. \>50) for CRFS.||||0.115
72395684|NCT02345850|144297647|SUPERIORITY|||||||0.227||||||A Bonferroni adjusted significance level of 0.05/3=0.0167 is used for each of three interaction tests to account for multiple testing.|Cox proportional hazards regression|||Subgroup analyses are conducted for CRFS according to disease, disease risk and age. Interaction tests between treatment group and subgroup are conducted within a Cox proportional hazards regression model with treatment, subgroup, and a treatment\*subgroup interaction term. The null hypothesis is that there is no Interaction between treatment group and Disease (AML vs. ALL vs. MDS) for CRFS.||||0.227
72395685|NCT02345850|144297648|SUPERIORITY||Hazard Ratio (HR)|1.744||||0.0197|TWO_SIDED|95.0|1.086|2.8||The OS pairwise comparisons are tested at a Bonferroni adjusted significance level of 0.05/3.|Log Rank|||The null hypothesis is that there is no difference of the OS hazard ratio between CD34 select graft vs. Tac/MTX Control.||2.800|1.086|0.0197
72395686|NCT02345850|144297648|SUPERIORITY||Hazard Ratio (HR)|1.016||||0.9525|TWO_SIDED|95.0|0.599|1.724||The OS pairwise comparisons are tested at a Bonferroni adjusted significance level of 0.05/3.|Log Rank|||The null hypothesis is that there is no difference of the OS hazard ratio between Post-Transplant Cyclophosphamide vs. Tac/MTX Control.||1.724|0.599|0.9525
72395687|NCT02345850|144297648|SUPERIORITY||Hazard Ratio (HR)|1.774||||0.0185|TWO_SIDED|95.0|1.093|2.877||The OS pairwise comparisons are tested at a Bonferroni adjusted significance level of 0.05/3.|Log Rank|||The null hypothesis is that there is no difference of the OS hazard ratio between CD34 select graft vs. Post-Transplant Cyclophosphamide.||2.877|1.093|0.0185
72395688|NCT02345850|144297648|SUPERIORITY|||||||0.026||||||Statistical significance was determined using a pre-specified threshold of 0.05.|Regression, Cox|||The null hypothesis is that there is no difference of the OS hazard ratio between treatment groups after adjustment for age, donor type, performance status, primary disease, and disease risk.||||0.026
72395689|NCT02345850|144297649|SUPERIORITY|||||||0.029||||||Statistical significance was determined using a pre-specified threshold of 0.05.|Log Rank|||The null hypothesis is that there is no difference of Relapse-Free Survival between the treatment groups.||||0.029
72395690|NCT02345850|144297649|SUPERIORITY|||||||0.145||||||Statistical significance was determined using a pre-specified threshold of 0.05.|Regression, Cox|||The null hypothesis is that there is no difference of the RFS hazard ratio between treatment groups after adjustment for age, donor type, performance status, primary disease, and disease risk.||||0.145
72395691|NCT02345850|144297650|SUPERIORITY|||||||0.02||||||Statistical significance was determined using a pre-specified threshold of 0.05.|Gray's test for cumulative Incidence|||The null hypothesis is that there is no difference of Transplant-Related Mortality between the treatment groups.||||0.020
72576740|NCT00351533|144680435|SUPERIORITY_OR_OTHER|||||||0.69||95.0|||||t-test, 2 sided|||||||0.69
72395692|NCT02345850|144297650|SUPERIORITY|||||||0.04||||||Statistical significance was determined using a pre-specified threshold of 0.05.|Regression, Cox|||The null hypothesis is that there is no difference of the TRM hazard ratio between treatment groups after adjustment for age, donor type, performance status, primary disease, and disease risk.||||0.040
72395693|NCT02345850|144297651|SUPERIORITY|||||||0.2389||||||Statistical significance was determined using a pre-specified threshold of 0.05.|Chi-squared|||The null hypothesis is that there is no difference of immunosuppression-free survival at 1-year post-transplant between the treatment groups.||||0.2389
72395694|NCT02345850|144297651|SUPERIORITY||||||<|0.0001|||||||Cohen's Kappa|||The null hypothesis is that there is no agreement between CRFS and immunosuppression-free survival at 1-year post-transplant.||||<0.0001
72395695|NCT02345850|144297652|SUPERIORITY|||||||0.076||||||Statistical significance was determined using a pre-specified threshold of 0.05.|Gray's test for cumulative Incidence|||The null hypothesis is that there is no difference of Disease Relapse between the treatment groups.||||0.076
72505816|NCT00958568|144542809|SUPERIORITY_OR_OTHER|||||||1||95.0||||The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.|Fisher Exact|||||||1.00
72505817|NCT00958568|144542810|SUPERIORITY_OR_OTHER|||||||0.248||95.0||||The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.|Fisher Exact|||||||0.248
72395696|NCT02345850|144297652|SUPERIORITY|||||||0.106||||||Statistical significance was determined using a pre-specified threshold of 0.05.|Regression, Cox|||The null hypothesis is that there is no difference of the Disease Relapse hazard ratio between treatment groups after adjustment for age, donor type, performance status, primary disease, and disease risk.||||0.106
72395697|NCT02345850|144297653|SUPERIORITY|||||||0.0764||||||Statistical significance was determined using a pre-specified threshold of 0.05.|Gray's test for cumulative Incidence|||The null hypothesis is that there is no difference of Neutrophil Engraftment post-transplantation between the treatment groups.||||0.0764
72395698|NCT02345850|144297654|SUPERIORITY|||||||0.0001||||||Statistical significance was determined using a pre-specified threshold of 0.05.|Gray's test for cumulative Incidence|||The null hypothesis is that there is no difference of Platelet recovery post-transplantation between the treatment groups.||||0.0001
72395699|NCT02345850|144297656|SUPERIORITY|||||||0.1478|||||||Gray's test for cumulative Incidence|||The null hypothesis is that there is no difference of Secondary graft failure post-transplantation between the treatment groups.||||0.1478
72395700|NCT02345850|144297657|SUPERIORITY|||||||0.0026||||||Statistical significance was determined using a pre-specified threshold of 0.05.|Gray's test for cumulative Incidence|||The null hypothesis is that there is no difference of grade II-IV acute GVHD post-transplantation between the treatment groups.||||0.0026
72395701|NCT02345850|144297657|SUPERIORITY|||||||0.0369||||||Statistical significance was determined using a pre-specified threshold of 0.05.|Gray's test for cumulative Incidence|||The null hypothesis is that there is no difference of grade III-IV acute GVHD post-transplantation between the treatment groups.||||0.0369
72395702|NCT02345850|144297657|SUPERIORITY|||||||0.002||||||Statistical significance was determined using a pre-specified threshold of 0.05.|Regression, Cox|||The null hypothesis is that there is no difference of the grade II-IV acute GVHD hazard ratio between treatment groups after adjustment for age, donor type, performance status, primary disease, and disease risk.||||0.002
72395703|NCT02345850|144297657|SUPERIORITY|||||||0.046||||||Statistical significance was determined using a pre-specified threshold of 0.05.|Regression, Cox|||The null hypothesis is that there is no difference of the grade III-IV acute GVHD hazard ratio between treatment groups after adjustment for age, donor type, performance status, primary disease, and disease risk.||||0.046
72395704|NCT02345850|144297659|SUPERIORITY|||||||0.0024||||||Statistical significance was determined using a pre-specified threshold of 0.05.|Gray's test for cumulative Incidence|||The null hypothesis is that there is no difference of chronic GVHD post-transplantation between the treatment groups.||||0.0024
72395705|NCT02345850|144297659|SUPERIORITY|||||||0.005||||||Statistical significance was determined using a pre-specified threshold of 0.05.|Regression, Cox|||The null hypothesis is that there is no difference of the chronic GVHD hazard ratio between treatment groups after adjustment for age, donor type, performance status, primary disease, and disease risk.||||0.005
72395706|NCT02345850|144297660|SUPERIORITY|||||||0.229||||||Statistical significance was determined using a pre-specified threshold of 0.05.|Log Rank|||The null hypothesis is that there is no difference of Chronic GVHD-free Survival post-transplantation between the treatment groups.||||0.229
72395707|NCT02345850|144297662|SUPERIORITY|||||||0.0006||||||Superiority - Statistical significance was determined using a pre-specified threshold of 0.05.|Gray's test for cumulative Incidence|||The null hypothesis is that there is no difference of Grades II-III infection post-transplantation between the treatment groups.||||0.0006
72576741|NCT00351533|144680436|SUPERIORITY_OR_OTHER|||||||0.66||95.0|||||t-test, 2 sided|||||||0.66
72576742|NCT00351533|144680437|SUPERIORITY_OR_OTHER|||||||0.27||95.0|||||t-test, 2 sided|||||||0.27
72395708|NCT02345850|144297662|SUPERIORITY|||||||0.0145||||||Statistical significance was determined using a pre-specified threshold of 0.05.|Gray's test for cumulative Incidence|||The null hypothesis is that there is no difference of Grades III infection post-transplantation between the treatment groups.||||0.0145
72395709|NCT02715076|144297671|OTHER||||||<|0.05|||||||mixed-effects model|||||||<0.05
72395710|NCT01991067|144297672|OTHER|Furthermore, a multivariable logistic regression model was applied accounting for group as well as age, body mass index, and gender as possible influence factors.|||||<|0.001||||||The threshold for statistical significance was a p-value of \<0.05.|Fisher Exact|||The calculation of the sample size was performed using nQuery 6.1. The primary endpoint was the outcome of the NT 4 weeks after the second vaccination. A Fisher exact tes was calculated to analyze the primary hypothesis on the difference in NT-titer response between patients and controls||||<0.001
72395711|NCT01991067|144297673|OTHER|||||||0.02|||||||Fisher Exact|||A Fisher exact test was calculated to analyze antibody response by ELISA between patients and controls. To measure the Agreement between the NT and ELISA response, Cohens Kappa and the corresponding 95% confidence interval were calculated||||0.02
72395712|NCT01991067|144297674|OTHER||||||<|0.01|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||"For titer values the geometric mean was calculated and the corresponding two-sided 95% confidence intervals were constructed by back-transfomration of the CI for the mean of the logarithmically transformed results.~To investigate the difference in absolute titer values and geometric mean fold changes between time point and Groups, Wilcoxon tests were performed."||||<0.01
72395713|NCT01075204|144297683|SUPERIORITY_OR_OTHER|||||||0.334||95.0|||||Chi-squared|9 degrees of freedom.||Logistic regression: Omnibus Test of Model Coefficients (all the nine variables are considered together).||||0.334
72395714|NCT02425046|144297704|SUPERIORITY|||||||0.67||||||Threshold for statistical significance \<0.05|t-test, 2 sided|Multiple imputation used to fill in missing data - imputation included demographic and 6 month data. 5 datasets created and results averaged.||||||0.67
72395715|NCT02425046|144297705|SUPERIORITY|||||||0.735|||||||t-test, 2 sided|Multiple imputation used to fill in missing data - imputation included demographic and 6 month data. 5 datasets created and results averaged.||null hypothesis - there will be no difference between the groups.||||0.735
72395716|NCT02425046|144297706|SUPERIORITY|||||||0.599|||||||t-test, 2 sided|Multiple imputation used to fill in missing data - imputation included demographic and 6 month data. 5 datasets created and results averaged.||Null hypothesis that there would be no difference in change in FNPA scores between the two groups over 12 months.||||0.599
72395717|NCT02425046|144297707|SUPERIORITY|||||||0.583|||||||t-test, 2 sided|Multiple imputation used to fill in missing data - imputation included demographic and 6 month data. 5 datasets created and results averaged.||Null hypothesis: Change in MVPA from baseline to 12 months will not be different between target children in the two groups.||||0.583
72395718|NCT02425046|144297708|SUPERIORITY|||||||0.312|||||||t-test, 2 sided|Multiple imputation including demographics and 6 month data used to complete dataset. 5 datasets created and t-score averaged.||Null hypothesis is that there will be no difference between the two arms in change in sugar sweetened beverage intake over 12 months.||||0.312
72395719|NCT02425046|144297709|SUPERIORITY||difference in change between two arms|75.0||||0.1|TWO_SIDED|95.0|-15.0|165.0|||Linear quantile mixed model|Linear quantile mixed models (a non-parametric linear mixed model) was used because of non-normal distribution that could not be transformed.|Comparison of the intervention target adult change in reported physical activity compared to the control group.|Linear quantile mixed models (a non-parametric linear mixed model) was used because because of non-normal distribution that could not be remedied by transformation.||165|-15|0.10
72395720|NCT02425046|144297710|SUPERIORITY||difference in change between two arms|-2.54||||0.057|TWO_SIDED|95.0|-5.14|0.07|||Mixed Models Analysis||The intervention arm in comparison to the control arm.|||0.07|-5.14|0.057
72395721|NCT02425046|144297711|SUPERIORITY|||||||0.874|||||||t-test, 2 sided|Multiple imputation including demographics and 6 month data used to complete dataset. 5 datasets created and t-score averaged.||||||0.874
72395722|NCT02425046|144297712|SUPERIORITY||% difference in change between arms|7.0||||0.31|TWO_SIDED|95.0|-7.0|23.0|||Mixed Models Analysis|Screen time was log transformed to normalized the distribution. Results have been back transformed from log 10 scale.|% change in screen time of the intervention arm compared to the control arm.|||23|-7|0.31
72395723|NCT02425046|144297713|SUPERIORITY|||||||0.516|||||||t-test, 2 sided|Multiple imputation including demographics and 6 month data used to complete dataset. 5 datasets created and t-score averaged.||||||0.516
72395724|NCT02692716|144297714|NON_INFERIORITY|This hypothesis was controlled for multiplicity. Non-inferiority of oral semaglutide versus placebo was considered confirmed if the upper limit of the two-sided 95% confidence interval for the HR was strictly below 1.8.|Hazard Ratio (HR)|0.79|||<|0.0001|TWO_SIDED|95.0|0.57|1.11||Unadjusted two-sided p-value for test of no difference from the non-inferiority margin (non-inferiority).|Regression, Cox|||Data from the in-trial observation period. Time from randomisation to first event adjudication committee (EAC) confirmed MACE was analysed using a Cox proportional hazards model with treatment as categorical fixed factor and stratified by evidence of cardiovascular disease at screening. Participants were censored at the end of their in-trial observation period.||1.11|0.57|< 0.0001
72395725|NCT02692716|144297714|SUPERIORITY|This hypothesis was controlled for multiplicity.|Hazard Ratio (HR)|0.79|||=|0.1749|TWO_SIDED|95.0|0.57|1.11||Unadjusted two-sided p-value from test of no difference from 1 (superiority).|Regression, Cox|||Data from the in-trial observation period. Time from randomisation to first EAC-confirmed MACE was analysed using a Cox proportional hazards model with treatment as categorical fixed factor and stratified by evidence of cardiovascular disease at screening. Participants were censored at the end of their in-trial observation period.||1.11|0.57|= 0.1749
72395726|NCT02692716|144297715|OTHER|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|0.82|||=|0.1827|TWO_SIDED|95.0|0.61|1.1||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox|||Data from the in-trial observation period. Time from randomisation to first EAC-confirmed expanded cardiovascular outcome was analysed using a Cox proportional hazards model with treatment as categorical fixed factor and stratified by evidence of cardiovascular disease at screening. Participants were censored at the end of their in-trial observation period.||1.10|0.61|= 0.1827
72395727|NCT02692716|144297716|OTHER|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|0.49|||=|0.0261|TWO_SIDED|95.0|0.27|0.92||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox|||Data from the in-trial observation period. Time from randomisation to first EAC-confirmed cardiovascular death (including undetermined cause of death) was analysed using a Cox proportional hazards model with treatment as categorical fixed factor and stratified by evidence of cardiovascular disease at screening. Participants were censored at the end of their in-trial observation period.||0.92|0.27|= 0.0261
72576743|NCT00351533|144680438|SUPERIORITY_OR_OTHER|||||||0.65||95.0|||||Chi-squared|||||||0.65
72395728|NCT02692716|144297716|OTHER|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|1.18|||=|0.5044|TWO_SIDED|95.0|0.73|1.9||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox|||Data from the in-trial observation period. Time from randomisation to first EAC-confirmed non-fatal myocardial infarction was analysed using a Cox proportional hazards model with treatment as categorical fixed factor and stratified by evidence of cardiovascular disease at screening. Participants were censored at the end of their in-trial observation period.||1.90|0.73|= 0.5044
72395729|NCT02692716|144297716|OTHER|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|0.74|||=|0.435|TWO_SIDED|95.0|0.35|1.57||Unadjusted two-sided p-value for test of no difference from 1|Regression, Cox|||Data from the in-trial observation period. Time from randomisation to first EAC-confirmed non-fatal stroke was analysed using a Cox proportional hazards model with treatment as categorical fixed factor and stratified by evidence of cardiovascular disease at screening. Participants were censored at the end of their in-trial observation period.||1.57|0.35|= 0.4350
72471423|NCT02358668|144466614|SUPERIORITY_OR_OTHER||Mean Difference (Net)|40.0||||0.34|TWO_SIDED|95.0|-43.9|123.9||The p-value of treatment effects relative to placebo was obtained by ANCOVA analysis comparing the outcome values adjusted for age, gender and baseline measurements.|ANCOVA|||||123.9|-43.9|0.34
72471424|NCT02358668|144466615|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-980.0||||0.23|TWO_SIDED|95.0|-2604.0|643.8||The p-value of treatment effects relative to placebo was obtained by ANCOVA analysis comparing the outcome values adjusted for age, gender and baseline measurements.|ANCOVA|||||643.8|-2604|0.23
72471425|NCT02358668|144466615|SUPERIORITY_OR_OTHER||Mean Difference (Net)|323.9||||0.68|TWO_SIDED|95.0|-1269.0|1916.6||The p-value of treatment effects relative to placebo was obtained by ANCOVA analysis comparing the outcome values adjusted for age, gender and baseline measurements.|ANCOVA|||||1916.6|-1269|0.68
72471426|NCT02358668|144466616|SUPERIORITY_OR_OTHER||Mean Difference (Net)|15.0||||0.79|TWO_SIDED|95.0|-99.6|129.6||The p-value of treatment effects relative to placebo was obtained by ANCOVA analysis comparing the outcome values adjusted for age, gender and baseline measurements.|ANCOVA|||||129.6|-99.6|0.79
72471427|NCT02358668|144466616|SUPERIORITY_OR_OTHER||Mean Difference (Net)|60.1||||0.29|TWO_SIDED|95.0|-52.5|172.6||The p-value of treatment effects relative to placebo was obtained by ANCOVA analysis comparing the outcome values adjusted for age, gender and baseline measurements.|ANCOVA|||||172.6|-52.5|0.29
72395730|NCT02692716|144297716|OTHER|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|1.56|||=|0.3605|TWO_SIDED|95.0|0.6|4.01||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox|||Data from the in-trial observation period. Time from randomisation to first EAC-confirmed unstable angina pectoris requiring hospitalisation was analysed using a Cox proportional hazards model with treatment as categorical fixed factor and stratified by evidence of cardiovascular disease at screening. Participants were censored at the end of their in-trial observation period.||4.01|0.60|= 0.3605
72395731|NCT02692716|144297716|OTHER|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|0.86|||=|0.6227|TWO_SIDED|95.0|0.48|1.55||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox|||Data from the in-trial observation period. Time from randomisation to first EAC-confirmed hospitalisation for heart failure was analysed using a Cox proportional hazards model with treatment as categorical fixed factor and stratified by evidence of cardiovascular disease at screening. Participants were censored at the end of their in-trial observation period.||1.55|0.48|= 0.6227
72395732|NCT02692716|144297717|OTHER|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|0.77|||=|0.0952|TWO_SIDED|95.0|0.56|1.05||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox|||Data from the in-trial observation period. Time from randomisation to first EAC-confirmed all-cause death, non-fatal myocardial infarction or non-fatal stroke was analysed using a Cox proportional hazards model with treatment as categorical fixed factor and stratified by evidence of cardiovascular disease at screening. Participants were censored at the end of their in-trial observation period.||1.05|0.56|= 0.0952
72395733|NCT02692716|144297718|OTHER|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|1.04||||0.8583|TWO_SIDED|95.0|0.66|1.66||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox|||Data from the on-treatment observation period. Time from first dose of trial product to first EAC-confirmed fatal or non-fatal myocardial infarction was analysed using a Cox proportional hazards model with treatment as categorical fixed factor and stratified by evidence of cardiovascular disease at screening. Participants were censored at the end of their on-treatment observation period.||1.66|0.66|0.8583
72395734|NCT02692716|144297719|OTHER|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|0.76||||0.4485|TWO_SIDED|95.0|0.37|1.56||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox|||Data from the in-trial observation period. Time from randomisation to first EAC-confirmed fatal or non-fatal stroke was analysed using a Cox proportional hazards model with treatment as categorical fixed factor and stratified by evidence of cardiovascular disease at screening. Participants were censored at the end of their in-trial observation period.||1.56|0.37|0.4485
72395735|NCT02692716|144297720|OTHER|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|0.51||||0.0078|TWO_SIDED|95.0|0.31|0.84||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox|||Data from the in-trial observation period. Time from randomisation to first EAC-confirmed all-cause death was analysed using a Cox proportional hazards model with treatment as categorical fixed factor and stratified by evidence of cardiovascular disease at screening. Participants were censored at the end of their in-trial observation period.||0.84|0.31|0.0078
72395736|NCT02692716|144297721|OTHER|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|1.81|||<|0.0001|TWO_SIDED|95.0|1.42|2.3||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox|||Data from date of first dose of trial product to date of end of treatment visit. Time from first dose to first AE leading to permanent trial product discontinuation was analysed using a Cox proportional hazards model with treatment as categorical fixed factor and stratified by evidence of cardiovascular disease at screening. Participants were censored at the date of their end of treatment visit or at their end of study date, whichever came first.||2.30|1.42|<0.0001
72395737|NCT02782780|144297732|SUPERIORITY|Linear mixed models with random effects for subjects were used to analyze all available data for the intent-to-treat analysis. Because sex was used as a stratification variable in the randomization procedure, it was not included as a covariate the analyses|||||<|0.01||||||Test of treatment effect: t(91.6)=3.21|Mixed Models Analysis|||||||<0.01
72395738|NCT02782780|144297732|SUPERIORITY||||||<|0.001||||||Baseline vs. 6-month follow-up in CBTI group: t(92.3)=4.10|Mixed Models Analysis|Planned contrasts following the mixed models were used to compare baseline data to 6-month follow-up data in the CBTI group.||||||<0.001
72395739|NCT02782780|144297733|SUPERIORITY|Linear mixed models with random effects for subjects were used to analyze all available data for the intent-to-treat analysis. Because sex was used as a stratification variable in the randomization procedure, it was not included as a covariate the analyses|||||<|0.001||||||test of treatment effect: t(94.7)=6.10|Mixed Models Analysis|||||||<0.001
72505818|NCT00958568|144542811|SUPERIORITY_OR_OTHER|||||||1||95.0||||The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.|Fisher Exact|||||||1.00
72505819|NCT00958568|144542812|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.91|STANDARD_ERROR_OF_MEAN|4.47||0.839|TWO_SIDED|95.0|-9.71|7.89||The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.|t-test, 2 sided|The model adjusted for baseline (Week 20), treatment, country, visit, and treatment-by-visit interaction.||||7.89|-9.71|0.839
72576744|NCT00351533|144680439|SUPERIORITY_OR_OTHER|||||||0.49||95.0|||||Chi-squared|||||||0.49
72576745|NCT00351533|144680440|SUPERIORITY_OR_OTHER|||||||0.55||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.55
72576746|NCT00351533|144680441|SUPERIORITY_OR_OTHER|||||||0.38||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.38
72576747|NCT00351533|144680442|SUPERIORITY_OR_OTHER|||||||0.84||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.84
72576748|NCT00351533|144680443|SUPERIORITY_OR_OTHER|||||||0.74||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.74
72576749|NCT00351533|144680444|SUPERIORITY_OR_OTHER|||||||0.84||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.84
72576750|NCT00351533|144680445|SUPERIORITY_OR_OTHER|||||||0.71||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.71
72576751|NCT00351533|144680446|SUPERIORITY_OR_OTHER|||||||0.08||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.08
72576752|NCT00351533|144680447|SUPERIORITY_OR_OTHER|||||||0.86||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.86
72576753|NCT00351533|144680448|SUPERIORITY_OR_OTHER|||||||0.89||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.89
72576754|NCT00351533|144680449|SUPERIORITY_OR_OTHER|||||||0.34||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.34
72471428|NCT02358668|144466617|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-120.2||||0.37|TWO_SIDED|95.0|-385.3|144.9||The p-value of treatment effects relative to placebo was obtained by ANCOVA analysis comparing the outcome values adjusted for age, gender and baseline measurements.|ANCOVA|||||144.9|-385.3|0.37
72471429|NCT02358668|144466617|SUPERIORITY_OR_OTHER||Mean Difference (Net)|49.0||||0.69|TWO_SIDED|95.0|-198.1|296.2||The p-value of treatment effects relative to placebo was obtained by ANCOVA analysis comparing the outcome values adjusted for age, gender and baseline measurements.|ANCOVA|||||296.2|-198.1|0.69
72471430|NCT02358668|144466619|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.2||||0.57|TWO_SIDED|95.0|-9.8|5.5||The p-value of treatment effects relative to placebo was obtained by ANCOVA analysis comparing the outcome values adjusted for age, gender and baseline measurements.|ANCOVA|||||5.5|-9.8|0.57
72471431|NCT02358668|144466619|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.0||||0.79|TWO_SIDED|95.0|-6.6|8.6||The p-value of treatment effects relative to placebo was obtained by ANCOVA analysis comparing the outcome values adjusted for age, gender and baseline measurements.|ANCOVA|||||8.6|-6.6|0.79
72471432|NCT02358668|144466620|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.8||||0.54|TWO_SIDED|95.0|-3.4|1.8||The p-value of treatment effects relative to placebo was obtained by ANCOVA analysis comparing the outcome values adjusted for age, gender and baseline measurements.|ANCOVA|||||1.8|-3.4|0.54
72471433|NCT02358668|144466620|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.5||||0.68|TWO_SIDED|95.0|-2.0|3.1||The p-value of treatment effects relative to placebo was obtained by ANCOVA analysis comparing the outcome values adjusted for age, gender and baseline measurements.|ANCOVA|||||3.1|-2.0|0.68
72471434|NCT02358668|144466621|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.7||||0.03|TWO_SIDED|95.0|-3.2|-0.1||The p-value of treatment effects relative to placebo was obtained by ANCOVA analysis comparing the outcome values adjusted for age, gender and baseline measurements.|ANCOVA|||||-0.1|-3.2|0.03
72471435|NCT02358668|144466621|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1||||0.86|TWO_SIDED|95.0|-1.7|1.4||The p-value of treatment effects relative to placebo was obtained by ANCOVA analysis comparing the outcome values adjusted for age, gender and baseline measurements.|ANCOVA|||||1.4|-1.7|0.86
72395740|NCT02782780|144297733|SUPERIORITY||||||<|0.001||||||baseline vs. 6-month follow-up in CBTI group: t(94)=6.67|Mixed Models Analysis|Planned contrasts following the mixed models were used to compare baseline data to 6-month follow-up data in the CBTI group.||To compare baseline data to 6-month follow-up data in the CBT-I group, planned contrasts following the mixed models were used.||||<0.001
72395741|NCT02782780|144297734|SUPERIORITY|Linear mixed models with random effects for subjects were used to analyze all available data for the intent-to-treat analysis. Because sex was used as a stratification variable in the randomization procedure, it was not included as a covariate the analyses|||||<|0.001|||||||Mixed Models Analysis|test of treatment effect: t(104)=3.40||||||<0.001
72395742|NCT02782780|144297734|SUPERIORITY||||||<|0.001||||||Baseline vs. 6-month follow-up in CBTi group: t(91.6)=4.37|Mixed Models Analysis|Planned contrasts following the mixed models were used to compare baseline data to 6-month follow-up data in the CBTi group.||||||<0.001
72395743|NCT02782780|144297735|SUPERIORITY|Linear mixed models with random effects for subjects were used to analyze all available data for the intent-to-treat analysis. Because sex was used as a stratification variable in the randomization procedure, it was not included as a covariate the analyses|||||<|0.05|||||||Mixed Models Analysis|test of treatment effect: t(99.9)=2.09||||||<0.05
72565631|NCT02709486|144662690|SUPERIORITY||Odds Ratio (OR)|1.9||||0.0005|TWO_SIDED|95.0|1.32|2.73|||Regression, Logistic|||Week 8: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.73|1.32|0.0005
72471436|NCT02358668|144466622|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.03||||0.9|TWO_SIDED|95.0|-0.39|0.44||The p-value of treatment effects relative to placebo was obtained by ANCOVA analysis comparing the outcome values adjusted for age, gender and baseline measurements.|ANCOVA|||||0.44|-0.39|0.90
72471437|NCT02358668|144466622|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.22||||0.3|TWO_SIDED|95.0|-0.63|0.2||The p-value of treatment effects relative to placebo was obtained by ANCOVA analysis comparing the outcome values adjusted for age, gender and baseline measurements.|ANCOVA|||||0.20|-0.63|0.30
72471438|NCT02358668|144466623|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.62||||0.52|TWO_SIDED|95.0|-1.32|2.57||The p-value of treatment effects relative to placebo was obtained by ANCOVA analysis comparing the outcome values adjusted for age, gender and baseline measurements.|ANCOVA|||||2.57|-1.32|0.52
72471439|NCT02358668|144466623|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.13||||0.24|TWO_SIDED|95.0|-0.75|3.05||The p-value of treatment effects relative to placebo was obtained by ANCOVA analysis comparing the outcome values adjusted for age, gender and baseline measurements.|ANCOVA|||||3.05|-0.75|0.24
72471440|NCT02358668|144466624|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.002||||0.93|TWO_SIDED|95.0|-0.035|0.038||The p-value of treatment effects relative to placebo was obtained by ANCOVA analysis comparing the outcome values adjusted for age, gender and baseline measurements.|ANCOVA|||||0.038|-0.035|0.93
72471441|NCT02358668|144466624|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.015||||0.4|TWO_SIDED|95.0|-0.021|0.051||The p-value of treatment effects relative to placebo was obtained by ANCOVA analysis comparing the outcome values adjusted for age, gender and baseline measurements.|ANCOVA|||||0.051|-0.021|0.40
72565632|NCT02709486|144662690|SUPERIORITY||Odds Ratio (OR)|1.94||||0.0009|TWO_SIDED|95.0|1.31|2.86|||Regression, Logistic|||Week 12: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.86|1.31|0.0009
72471442|NCT02358668|144466625|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.4||||0.36|TWO_SIDED|95.0|-1.2|0.5||The p-value of treatment effects relative to placebo was obtained by ANCOVA analysis comparing the outcome values adjusted for age, gender and baseline measurements.|ANCOVA|||||0.5|-1.2|0.36
72471443|NCT02358668|144466625|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.4||||0.36|TWO_SIDED|95.0|-0.4|1.2||The p-value of treatment effects relative to placebo was obtained by ANCOVA analysis comparing the outcome values adjusted for age, gender and baseline measurements.|ANCOVA|||||1.2|-0.4|0.36
72471444|NCT02358668|144466626|SUPERIORITY_OR_OTHER|||||||0.09||||||The univariate p-value of treatment group was obtained by t-tests comparing the changes to that of placebo group|t-test, 2 sided|||||||0.09
72395744|NCT02782780|144297735|SUPERIORITY||||||<|0.01|||||||Mixed Models Analysis|Baseline vs. 6-month follow-up in CBTi group: t(92.1)=2.56||Planned contrasts following the mixed models were used to compare baseline data to 6-month follow-up data in the CBTi group.||||<0.01
72395745|NCT02782780|144297736|SUPERIORITY|Linear mixed models with random effects for subjects were used to analyze all available data for the intent-to-treat analysis. Because sex was used as a stratification variable in the randomization procedure, it was not included as a covariate the analyses|||||=|0.991|||||||Mixed Models Analysis|Test of treatment effect: t(110)=-0.41||||||=0.991
72395746|NCT02782780|144297736|SUPERIORITY||||||=|0.41||||||Baseline vs. 6-month follow-up in CBTi group: t(91.8)=0.94|Mixed Models Analysis|Planned contrasts following the mixed models were used to compare baseline data to 6-month follow-up data in the CBTi group.||||||=0.41
72395747|NCT02782780|144297737|SUPERIORITY|Linear mixed models with random effects for subjects were used to analyze all available data for the intent-to-treat analysis. Because sex was used as a stratification variable in the randomization procedure, it was not included as a covariate the analyses|||||<|0.05|||||||Mixed Models Analysis|Test of treatment effect: t(83.7)=2.51||||||<0.05
72505820|NCT00958568|144542813|SUPERIORITY_OR_OTHER|||||||0.352||95.0||||P-value is for Borderline to High. The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.|Fisher Exact|||||||0.352
72622868|NCT01251757|144775930|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.12||||0.014|TWO_SIDED|95.0|1.02|1.23||adjusted for site, gender, age, total number of prescription medications participant was taking, comorbid diabetes/CVD, baseline ACEI/ARB adherence|Regression, Logistic||Adjusted odds ratio for good adherence in IVR group versus UC group, calculated as IVR - UC.|We conducted separate primary analyses of each of IVR and IVR+ versus usual care at the .025 level of significance to assure a trial-wide error rate of .05. This analysis summary is for the IVR versus UC comparison only. Also, we only report results here for the full sample, and not also separately for the 3 baseline adherence level groups.||1.23|1.02|0.014
72622869|NCT01251757|144775930|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.21|||<|0.001|TWO_SIDED|95.0|1.1|1.32||Adjusted for site, gender, age, total number of prescription medications patient is taking, comorbid diabetes/CVD, and baseline statin adherence.|Regression, Logistic||Adjusted odds ratio for good adherence in IVR group versus UC group, calculated as IVR - UC.|We conducted separate primary analyses of each of IVR and IVR+ versus usual care at the .025 level of significance to assure a trial-wide error rate of .05. This analysis summary is for the IVR+ versus UC comparison only. Also, we only report results here for the full sample, and not also separately for the 3 baseline adherence level groups.||1.32|1.10|<0.001
72622870|NCT01251757|144775931|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5||||0.041|TWO_SIDED|95.0|-1.0|0.0||As noted above, the a priori threshold for statistical significance for this test was .025.|Regression, Linear|Adjusted for site, gender, age, total number of prescription medications patient is taking, comorbid diabetes/CVD, and baseline SBP group.||We conducted separate primary analyses of each of IVR and IVR+ versus usual care at the .025 level of significance to assure a trial-wide error rate of .05. This analysis summary is for the IVR versus UC comparison only. Also, we only report results here for the full sample, and not also separately for the 3 baseline SBP level groups.||0.0|-1.0|.041
72622871|NCT01251757|144775931|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.93|TWO_SIDED|95.0|-0.5|0.5||As noted above, the a priori threshold for statistical significance for this test was .025.|Regression, Linear|Adjusted for site, gender, age, total number of prescription medications participant is taking, comorbid diabetes/CVD, and baseline SBP group.||We conducted separate primary analyses of each of IVR and IVR+ versus usual care at the .025 level of significance to assure a trial-wide error rate of .05. This analysis summary is for the IVR+ versus UC comparison only. Also, we only report results here for the full sample, and not also separately for the 3 baseline SBP level groups.||.5|-.5|.93
72622872|NCT01251757|144775932|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.05||||0.404|TWO_SIDED|95.0|0.93|1.19||As noted above, the a priori threshold for statistical significance for this test was .025.|Regression, Logistic|Adjusted for site, gender, age, total number of prescription medications participant is taking, comorbid diabetes/CVD, and baseline SBP group||We conducted separate primary analyses of each of IVR and IVR+ versus usual care at the .025 level of significance to assure a trial-wide error rate of .05. This analysis summary is for the IVR versus UC comparison only. Also, we only report results here for the full sample, and not also separately for the 3 baseline SBP level groups.||1.19|0.93|.404
72622873|NCT01251757|144775932|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.96||||0.54|TWO_SIDED|95.0|0.85|1.09||As noted above, the a priori threshold for statistical significance for this test was .025.|Regression, Logistic|Adjusted for site, gender, age, total number of prescription medications participant is taking, comorbid diabetes/CVD, and baseline SBP group||We conducted separate primary analyses of each of IVR and IVR+ versus usual care at the .025 level of significance to assure a trial-wide error rate of .05. This analysis summary is for the IVR+ versus UC comparison only. Also, we only report results here for the full sample, and not also separately for the 3 baseline SBP level groups.||1.09|.85|.54
72622874|NCT01251757|144775933|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6||||0.38|TWO_SIDED|95.0|-1.8|0.7||As noted above, the a priori threshold for statistical significance for this test was .025.|Regression, Linear|Adjusted for site, gender, age, total number of prescription medications participant is taking, comorbid diabetes/CVD, and baseline LDL group.||We conducted separate primary analyses of each of IVR and IVR+ versus usual care at the .025 level of significance to assure a trial-wide error rate of .05. This analysis summary is for the IVR versus UC comparison only. Also, we only report results here for the full sample, and not also separately for the 3 baseline LDL subgroups.||0.7|-1.8|.38
72395748|NCT02782780|144297737|SUPERIORITY||||||=|0.49||||||Planned contrasts following the mixed models were used to compare baseline data to 6-month follow-up data in the CBTi group.|Mixed Models Analysis|Baseline vs. 6-month follow-up in CBTi group: t(90.9)=0.27||||||=0.49
72395749|NCT02782780|144297738|SUPERIORITY|Linear mixed models with random effects for subjects were used to analyze all available data for the intent-to-treat analysis. Because sex was used as a stratification variable in the randomization procedure, it was not included as a covariate the analyses.|||||<|0.01|||||||Mixed Models Analysis|test of treatment effect: t(105)=4.55||||||<0.01
72505821|NCT00958568|144542813|SUPERIORITY_OR_OTHER|||||||1||95.0||||P-value is for Normal to Borderline. The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.|Fisher Exact|||||||1.00
72395750|NCT02782780|144297738|SUPERIORITY||||||<|0.01||||||Planned contrasts following the mixed models were used to compare baseline data to 6-month follow-up data in the CBTi group.|Mixed Models Analysis|Baseline vs. 6-month follow-up in CBTi group: t(91.3)=3.23||||||<0.01
72471445|NCT02358668|144466626|SUPERIORITY_OR_OTHER|||||||0.82||||||The univariate p-value of treatment group was obtained by t-tests comparing the changes to that of placebo group|t-test, 2 sided|||||||0.82
72471446|NCT02358668|144466627|SUPERIORITY_OR_OTHER|||||||0.68||||||The univariate p-value of treatment group was obtained by t-tests comparing the changes to that of placebo group|t-test, 2 sided|||||||0.68
72471447|NCT02358668|144466627|SUPERIORITY_OR_OTHER|||||||0.26||||||The univariate p-value of treatment group was obtained by t-tests comparing the changes to that of placebo group|t-test, 2 sided|||||||0.26
72505822|NCT00958568|144542813|SUPERIORITY_OR_OTHER|||||||1||95.0||||P-value is for Normal to High. The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.|Fisher Exact|||||||1.00
72505823|NCT00958568|144542814|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.57|STANDARD_ERROR_OF_MEAN|4.12||0.703|TWO_SIDED|95.0|-9.69|6.54||The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.|t-test, 2 sided|The model adjusted for baseline (Week 20), treatment, country, visit, and treatment-by-visit interaction.||||6.54|-9.69|0.703
72505824|NCT00958568|144542815|SUPERIORITY_OR_OTHER|||||||0.139||95.0||||P-value is for Borderline to High. The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.|Fisher Exact|||||||0.139
72505825|NCT00958568|144542815|SUPERIORITY_OR_OTHER|||||||0.746||95.0||||P-value is for Normal to Borderline. The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.|Fisher Exact|||||||0.746
72505826|NCT00958568|144542815|SUPERIORITY_OR_OTHER|||||||0.458||95.0||||P-value is for Normal to High. The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.|Fisher Exact|||||||0.458
72505827|NCT00958568|144542816|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.73|STANDARD_ERROR_OF_MEAN|1.15||0.001|TWO_SIDED|95.0|-5.99|-1.47||The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.|t-test, 2 sided|The model adjusted for baseline (Week 20), treatment, country, visit, and treatment-by-visit interaction.||||-1.47|-5.99|0.001
72505828|NCT00958568|144542817|SUPERIORITY_OR_OTHER|||||||0.004||95.0||||The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.|Fisher Exact|||||||0.004
72505829|NCT00958568|144542818|SUPERIORITY_OR_OTHER|||||||1||95.0||||The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.|Fisher Exact|||||||1.00
72505830|NCT00958568|144542819|SUPERIORITY_OR_OTHER||LS Mean Difference|13.27|STANDARD_ERROR_OF_MEAN|7.62||0.083|TWO_SIDED|95.0|-1.72|28.26||The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.|t-test, 2 sided|The model adjusted for baseline (Week 20), treatment, country, visit, and treatment-by-visit interaction.||||28.26|-1.72|0.083
72505831|NCT00958568|144542820|SUPERIORITY_OR_OTHER|||||||0.029||95.0||||P-value is for Borderline to High. The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.|Fisher Exact|||||||0.029
72505832|NCT00958568|144542820|SUPERIORITY_OR_OTHER|||||||0.014||95.0||||P-value is for Normal to Borderline. The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.|Fisher Exact|||||||0.014
72505833|NCT00958568|144542820|SUPERIORITY_OR_OTHER|||||||0.054||95.0||||P-value is for Normal to High. The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.|Fisher Exact|||||||0.054
72505834|NCT00958568|144542821|SUPERIORITY_OR_OTHER||LS Mean Difference|5.89|STANDARD_ERROR_OF_MEAN|1.87||0.002|TWO_SIDED|95.0|2.22|9.56||The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.|t-test, 2 sided|The model adjusted for baseline (Week 20), treatment, country, visit, and treatment-by-visit interaction.||||9.56|2.22|0.002
72505835|NCT00958568|144542822|SUPERIORITY_OR_OTHER|||||||0.031||95.0||||P-value is for Impaired to High. The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.|Fisher Exact|||||||0.031
72505836|NCT00958568|144542822|SUPERIORITY_OR_OTHER|||||||1||95.0||||P-value is for Normal to High. The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.|Fisher Exact|||||||1.00
72471448|NCT02358668|144466628|SUPERIORITY_OR_OTHER|||||||0.67||||||The univariate p-value of treatment group was obtained by t-tests comparing the changes to that of placebo group|t-test, 2 sided|||||||0.67
72471449|NCT02358668|144466628|SUPERIORITY_OR_OTHER|||||||0.3||||||The univariate p-value of treatment group was obtained by t-tests comparing the changes to that of placebo group|t-test, 2 sided|||||||0.30
72471450|NCT02358668|144466629|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.3|||<|0.01|TWO_SIDED|95.0|-0.48|-0.11||The p-value of treatment effects (reference to placebo) were obtained by mixed effect model analysis comparing the outcome values adjusted with repeated measures, ages and gender.|Mixed Models Analysis|||||-0.11|-0.48|<0.01
72471451|NCT02358668|144466629|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.14||||0.13|TWO_SIDED|95.0|-0.32|0.04||The p-value of treatment effects (reference to placebo) were obtained by mixed effect model analysis comparing the outcome values adjusted with repeated measures, ages and gender.|Mixed Models Analysis|||||0.04|-0.32|0.13
72471452|NCT02358668|144466630|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.59||||0.01|TWO_SIDED|95.0|-1.01|-0.18||The p-value of treatment effects (reference to placebo) were obtained by mixed effect model analysis comparing the outcome values adjusted with repeated measures, ages and gender.|Mixed Models Analysis|||||-0.18|-1.01|0.01
72505837|NCT00958568|144542822|SUPERIORITY_OR_OTHER|||||||0.344||95.0||||P-value is for Normal to Impaired. The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.|Fisher Exact|||||||0.344
72395751|NCT02782780|144297739|SUPERIORITY|Linear mixed models with random effects for subjects were used to analyze all available data for the intent-to-treat analysis. Because sex was used as a stratification variable in the randomization procedure, it was not included as a covariate the analyses.|||||<|0.001|||||||Mixed Models Analysis|Test of treatment effect: t(91.6)=3.37||||||<0.001
72395752|NCT02782780|144297739|SUPERIORITY||||||<|0.001||||||Baseline vs. 6-month follow-up in CBTi group: (92.1)=3.64|Mixed Models Analysis|Planned contrasts following the mixed models were used to compare baseline data to 6-month follow-up data in the CBTi group.||||||<0.001
72395753|NCT02782780|144297740|SUPERIORITY|Linear mixed models with random effects for subjects were used to analyze all available data for the intent-to-treat analysis. Because sex was used as a stratification variable in the randomization procedure, it was not included as a covariate the analyses.|||||<|0.001|||||||Mixed Models Analysis|Test of treatment effect: t(99.2)=5.45||||||<0.001
72395754|NCT02782780|144297740|SUPERIORITY||||||<|0.001||||||Baseline vs. 6-month follow-up in CBTi group: t(93.4)=6.06|Mixed Models Analysis|Planned contrasts following the mixed models were used to compare baseline data to 6-month follow-up data in the CBTi group.||||||<0.001
72395755|NCT02782780|144297741|SUPERIORITY|Linear mixed models with random effects for subjects were used to analyze all available data for the intent-to-treat analysis. Because sex was used as a stratification variable in the randomization procedure, it was not included as a covariate the analyses.|||||<|0.001|||||||Mixed Models Analysis|test of treatment effect: t(76.9)=-4.20||||||<0.001
72395756|NCT02782780|144297741|SUPERIORITY||||||<|0.001||||||Baseline vs. 6-month follow-up in CBTi group: t(33.1)=6.52|Mixed Models Analysis|Planned contrasts following the mixed models were used to compare baseline data to 6-month follow-up data in the CBTi group.||||||<0.001
72395757|NCT02782780|144297742|SUPERIORITY|Linear mixed models with random effects for subjects were used to analyze all available data for the intent-to-treat analysis. Because sex was used as a stratification variable in the randomization procedure, it was not included as a covariate the analyses.|||||<|0.001|||||||Mixed Models Analysis|Test of treatment effect: t(75.6)=4.33||||||<0.001
72395758|NCT02782780|144297742|SUPERIORITY||||||<|0.001||||||Planned contrasts following the mixed models were used to compare baseline data to 6-month follow-up data in the CBTi group.|Mixed Models Analysis|Baseline vs. 6-month follow-up in CBTi group: t(34.4)=4.75||||||<0.001
72395759|NCT02782780|144297743|SUPERIORITY|Linear mixed models with random effects for subjects were used to analyze all available data for the intent-to-treat analysis. Because sex was used as a stratification variable in the randomization procedure, it was not included as a covariate the analyses.|||||<|0.001|||||||Mixed Models Analysis|Test of treatment effect: t(75.1)=3.91||||||<0.001
72395760|NCT02782780|144297743|SUPERIORITY||||||<|0.001||||||Planned contrasts following the mixed models were used to compare baseline data to 6-month follow-up data in the CBTi group.|Mixed Models Analysis|Baseline vs. 6-month in CBTi group: t(34.5)=4.39||||||<0.001
72471453|NCT02358668|144466630|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.17||||0.42|TWO_SIDED|95.0|-0.57|0.24||The p-value of treatment effects (reference to placebo) were obtained by mixed effect model analysis comparing the outcome values adjusted with repeated measures, ages and gender.|Mixed Models Analysis|||||0.24|-0.57|0.42
72471454|NCT02358668|144466631|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.74||||0.02|TWO_SIDED|95.0|-1.35|-0.14||The p-value of treatment effects (reference to placebo) were obtained by mixed effect model analysis comparing the outcome values adjusted with repeated measures, ages and gender.|Mixed Models Analysis|||||-0.14|-1.35|0.02
72471455|NCT02358668|144466631|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.17||||0.57|TWO_SIDED|95.0|-0.75|0.42||The p-value of treatment effects (reference to placebo) were obtained by mixed effect model analysis comparing the outcome values adjusted with repeated measures, ages and gender.|Mixed Models Analysis|||||0.42|-0.75|0.57
72395761|NCT03562481|144297744|EQUIVALENCE|Analysis of variance for a 2x2 crossover study implemented using the pkcross routine of Stata 16.1, accounting of sequence and period effects.|F statistic|0.8||||0.38|TWO_SIDED|||||The threshold for statistical significance p\<0.05|ANOVA|Analysis of variance for a 2x2 crossover study implemented using the pkcross routine of Stata 16.1, accounting of sequence and period effects.||||||0.38
72395762|NCT03562481|144297745|EQUIVALENCE|Equivalence was defined as a non-statistically significant difference.|F statistic|1.21||||0.28|TWO_SIDED|||||The threshold for statistical significance p\<0.05|ANOVA|||Analysis of variance for 2x2 crossover study using the pkcross routine of Stata 16.1 and accounting for sequence and period effects.||||0.28
72471456|NCT02358668|144466632|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.32|||<|0.01|TWO_SIDED|95.0|-0.52|-0.12||The p-value of treatment effects (reference to placebo) were obtained by mixed effect model analysis comparing the outcome values adjusted with repeated measures, ages and gender.|Mixed Models Analysis|||||-0.12|-0.52|<0.01
72471457|NCT02358668|144466632|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.15||||0.14|TWO_SIDED|95.0|-0.34|0.05||The p-value of treatment effects (reference to placebo) were obtained by mixed effect model analysis comparing the outcome values adjusted with repeated measures, ages and gender.|Mixed Models Analysis|||||0.05|-0.34|0.14
72395763|NCT03562481|144297746|EQUIVALENCE|Equivalence was defined based on statistical significance in the cross-over ANOVA.|F statistic|11.1||||0.003|TWO_SIDED|||||This is adjusted for period and sequence effects and is statistically significant at the p\<0.05 level.|ANOVA|||Analysis of variance for 2x2 crossover study using the pkcross routine of Stata 16.1 adjusting for perio and sequence effects.||||0.003
72395764|NCT03562481|144297747|EQUIVALENCE|Equivalence was determined based on the statistical significance of the Wilcoxon signed-rank test.|Z score|-0.996||||0.33|TWO_SIDED|||||The threshold for statistical significance p\<0.05|Sign test|Wilcoxon signed-rank test||||||0.33
72395765|NCT03562481|144297748|EQUIVALENCE|Equivalence was determined based on the statistical significance of the chi square test.|Chi-square test|0.81||||0.37|TWO_SIDED|||||The threshold for statistical significance p\<0.05|Chi-squared|||||||0.37
72395766|NCT03562481|144297749|EQUIVALENCE|Equivalence was defined based on statistical significance in the symmetry test.|Chi-square test|0.2||||0.65|TWO_SIDED|||||The threshold for statistical significance p\<0.05|Sruart-Maxwell symmetry test|||Stuart-Maxwell test of marginal homogeneity implemented with the symmetry routine in Stata 16.1||||0.65
72471458|NCT02358668|144466633|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.31|||<|0.01|TWO_SIDED|95.0|-0.52|-0.1||The p-value of treatment effects (reference to placebo) were obtained by mixed effect model analysis comparing the outcome values adjusted with repeated measures, ages and gender.|Mixed Models Analysis|||||-0.10|-0.52|<0.01
72471459|NCT02358668|144466633|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.09||||0.38|TWO_SIDED|95.0|-0.3|0.12||The p-value of treatment effects (reference to placebo) were obtained by mixed effect model analysis comparing the outcome values adjusted with repeated measures, ages and gender.|Mixed Models Analysis|||||0.12|-0.30|0.38
72471460|NCT02358668|144466634|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.27||||0.01|TWO_SIDED|95.0|-0.48|-0.07||The p-value of treatment effects (reference to placebo) were obtained by mixed effect model analysis comparing the outcome values adjusted with repeated measures, ages and gender.|Mixed Models Analysis|||||-0.07|-0.48|0.01
72471461|NCT02358668|144466634|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.08||||0.41|TWO_SIDED|95.0|-0.28|0.11||The p-value of treatment effects (reference to placebo) were obtained by mixed effect model analysis comparing the outcome values adjusted with repeated measures, ages and gender.|Mixed Models Analysis|||||0.11|-0.28|0.41
72471462|NCT02358668|144466635|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.19||||0.08|TWO_SIDED|95.0|-0.4|0.03||The p-value of treatment effects (reference to placebo) were obtained by mixed effect model analysis comparing the outcome values adjusted with repeated measures, ages and gender.|Mixed Models Analysis|||||0.03|-0.40|0.08
72565633|NCT02709486|144662690|SUPERIORITY||Odds Ratio (OR)|1.95||||0.0008|TWO_SIDED|95.0|1.32|2.89|||Regression, Logistic|||Week 12: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.89|1.32|0.0008
72471463|NCT02358668|144466635|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.17||||0.1|TWO_SIDED|95.0|-0.38|0.03||The p-value of treatment effects (reference to placebo) were obtained by mixed effect model analysis comparing the outcome values adjusted with repeated measures, ages and gender.|Mixed Models Analysis|||||0.03|-0.38|0.10
72471464|NCT02358668|144466636|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.39||||0.01|TWO_SIDED|95.0|-0.67|-0.12||The p-value of treatment effects (reference to placebo) were obtained by mixed effect model analysis comparing the outcome values adjusted with repeated measures, ages and gender.|Mixed Models Analysis|||||-0.12|-0.67|0.01
72505838|NCT00958568|144542822|SUPERIORITY_OR_OTHER|||||||0.072||95.0||||P-value is for Normal/Impaired to High. The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.|Fisher Exact|||||||0.072
72505839|NCT00958568|144542823|SUPERIORITY_OR_OTHER||LS Mean Difference|3.92|STANDARD_ERROR_OF_MEAN|0.49|<|0.001|TWO_SIDED|95.0|2.96|4.88||The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.|t-test, 2 sided|The model adjusted for baseline (Week 20), treatment, country, visit, and treatment-by-visit interaction.||||4.88|2.96|<0.001
72505840|NCT00958568|144542824|SUPERIORITY_OR_OTHER||||||<|0.001||||||The threshold for statistical significance was 0.05.|Fisher Exact|||||||<0.001
72505841|NCT00958568|144542825|SUPERIORITY_OR_OTHER|||||||0.392||95.0||||P-value is for suicidal ideation. The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.|Fisher Exact|||||||0.392
72505842|NCT00958568|144542826|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.57|STANDARD_ERROR_OF_MEAN|1.95||0.421|TWO_SIDED|95.0|-5.42|2.27||The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.|t-test, 2 sided|The model adjusted for baseline (Week 20), treatment, country, visit, and treatment-by-visit interaction.||||2.27|-5.42|0.421
72505843|NCT02927171|144542844|OTHER|||||||0.17|||||||t-test, 1 sided|||||||0.17
72505844|NCT02677701|144542848|SUPERIORITY||Mean Difference (Net)|3.44||||0.0846|TWO_SIDED|95.0|-0.48|7.35|||Regression, Linear|Adjusted for baseline: ppFEV1 (25%-50%, \>50%-75%, \>75%), azithromycin use (current vs. non-current), inhaled tobramycin type (powder vs. solution).||||7.35|-0.48|0.0846
72395767|NCT03562481|144297750|EQUIVALENCE|Equivalence was defined based on significance in the symmetry test.|Chi-square test|0.14||||0.71|TWO_SIDED|||||The threshold for statistical significance p\<0.05|Sruart-Maxwell symmetry test|||Test of symmetry or marginal homogeneity (Stuart-Maxwell) implemented with the symmetry routine in Stata 16.1.||||0.71
72471465|NCT02358668|144466636|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.08||||0.54|TWO_SIDED|95.0|-0.35|0.18||The p-value of treatment effects (reference to placebo) were obtained by mixed effect model analysis comparing the outcome values adjusted with repeated measures, ages and gender.|Mixed Models Analysis|||||0.18|-0.35|0.54
72471466|NCT02358668|144466637|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.42||||0.03|TWO_SIDED|95.0|-0.81|-0.03||The p-value of treatment effects (reference to placebo) were obtained by mixed effect model analysis comparing the outcome values adjusted with repeated measures, ages and gender.|Mixed Models Analysis|||||-0.03|-0.81|0.03
72471467|NCT02358668|144466637|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.09||||0.63|TWO_SIDED|95.0|-0.48|0.29||The p-value of treatment effects (reference to placebo) were obtained by mixed effect model analysis comparing the outcome values adjusted with repeated measures, ages and gender.|Mixed Models Analysis|||||0.29|-0.48|0.63
72471468|NCT02358668|144466638|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.05||||0.18|TWO_SIDED|95.0|-0.13|0.02||The p-value of treatment effects (reference to placebo) were obtained by mixed effect model analysis comparing the outcome values adjusted with repeated measures, ages and gender.|Mixed Models Analysis|||||0.02|-0.13|0.18
72471469|NCT02358668|144466638|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.01||||0.73|TWO_SIDED|95.0|-0.06|0.09||The p-value of treatment effects (reference to placebo) were obtained by mixed effect model analysis comparing the outcome values adjusted with repeated measures, ages and gender.|Mixed Models Analysis|||||0.09|-0.06|0.73
72505845|NCT02677701|144542849|SUPERIORITY||Mean Difference (Net)|1.31||||0.51|TWO_SIDED|95.0|-2.64|5.26|||Regression, Linear|Adjusted for baseline: ppFEV1 (25%-50%, \>50%-75%, \>75%), azithromycin use (current vs. non-current), inhaled tobramycin type (powder vs. solution).||||5.26|-2.64|0.51
72505846|NCT02677701|144542850|SUPERIORITY||Mean Difference (Net)|-2.89||||0.17|TWO_SIDED|95.0|-7.01|1.22|||Regression, Linear|Adjusted for baseline: ppFEV1 (25%-50%, \>50%-75%, \>75%), azithromycin use (current vs. non-current), inhaled tobramycin type (powder vs. solution).||||1.22|-7.01|0.17
72395768|NCT03562481|144297751|EQUIVALENCE|Equivalence was defined based on statistical significance in the symmetry test.|Chi-square test|1.0||||0.32|TWO_SIDED|||||The threshold for statistical significance p\<0.05|Sruart-Maxwell symmetry test|||Test of symmetry (marginal homogeneity, Stuart-Maxwell) implemented using the symmetry routine in Stata 16.1.||||0.32
72395769|NCT03562481|144297752|EQUIVALENCE|Equivalence was defined based on the statistical significance of the symmetry test.|Chi-square test|1.29||||0.26|TWO_SIDED||||||Sruart-Maxwell symmetry test|||Test of symmetry (marginal homogeneity, Stuart-Maxwell) implemented using the symmetry routine in Stata 16.1.||||0.26
72395770|NCT02533427|144297760|OTHER||% Geometric Least Square Mean(GLSM)Ratio|107.36|||||TWO_SIDED|90.0|103.19|111.69|||||Test/Reference: Norelgestromin Part B/Part A|Norelgestromin Part B/Part A||111.69|103.19|
72395771|NCT02533427|144297761|OTHER||% GLSM Ratio|115.14|||||TWO_SIDED|90.0|106.49|124.5|||||Test/Reference: Norgestrel Part B/Part A|Norgestrel Part B/Part A||124.50|106.49|
72395772|NCT02533427|144297762|OTHER||% GLSM Ratio|105.43|||||TWO_SIDED|90.0|96.95|114.66|||||Test/Reference: Ethinyl estradiol Part B/Part A|Ethinyl estradiol Part B/Part A||114.66|96.95|
72395773|NCT02533427|144297763|OTHER||% GLSM Ratio|248.89|||||TWO_SIDED|90.0|33.11|1870.81|||||Test/Reference: Norgestimate Part B/Part A|Norgestimate Part B/Part A||1870.81|33.11|
72395774|NCT02533427|144297764|OTHER||% GLSM Ratio|107.71|||||TWO_SIDED|90.0|97.78|118.65|||||Test/Reference: Norelgestromin Part B/Part A|Norelgestromin Part B/Part A||118.65|97.78|
72395775|NCT02533427|144297765|OTHER||% GLSM Ratio|115.02|||||TWO_SIDED|90.0|108.12|122.37|||||Test/Reference: Norgestrel Part B/Part A|Norgestrel Part B/Part A||122.37|108.12|
72471470|NCT02358668|144466639|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.07||||0.06|TWO_SIDED|95.0|-0.15|0.0||The p-value of treatment effects (reference to placebo) were obtained by mixed effect model analysis comparing the outcome values adjusted with repeated measures, ages and gender.|Mixed Models Analysis|||||0.00|-0.15|0.06
72395776|NCT02533427|144297766|OTHER||% GLSM Ratio|121.06|||||TWO_SIDED|90.0|106.1|138.12|||||Test/Reference: Ethinyl estradiol Part B/Part A|Ethinyl estradiol Part B/Part A||138.12|106.10|
72395777|NCT02533427|144297767|OTHER||% GLSM Ratio|112.11|||||TWO_SIDED|90.0|87.19|144.14|||||Test/Reference: Norgestimate Part B/Part A|Norgestimate Part B/Part A||144.14|87.19|
72471471|NCT02358668|144466639|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.03||||0.46|TWO_SIDED|95.0|-0.05|0.1||The p-value of treatment effects (reference to placebo) were obtained by mixed effect model analysis comparing the outcome values adjusted with repeated measures, ages and gender.|Mixed Models Analysis|||||0.10|-0.05|0.46
72471472|NCT02358668|144466640|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.07||||0.06|TWO_SIDED|95.0|-0.15|0.0||The p-value of treatment effects (reference to placebo) were obtained by mixed effect model analysis comparing the outcome values adjusted with repeated measures, ages and gender.|Mixed Models Analysis|||||0.00|-0.15|0.06
72471473|NCT02358668|144466640|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.03||||0.46|TWO_SIDED|95.0|-0.05|0.1||The p-value of treatment effects (reference to placebo) were obtained by mixed effect model analysis comparing the outcome values adjusted with repeated measures, ages and gender.|Mixed Models Analysis|||||0.10|-0.05|0.46
72505847|NCT02677701|144542851|SUPERIORITY||Mean Difference (Net)|1.53||||0.56|TWO_SIDED|95.0|-3.7|6.77||Adjusted for baseline: ppFEV1 (25%-50%, \>50%-75%, \>75%), azithromycin use (current vs. non-current), inhaled tobramycin type (powder vs. solution).|Regression, Linear|||||6.77|-3.70|0.56
72505848|NCT02677701|144542852|SUPERIORITY||Mean Difference (Net)|0.75||||0.043|TWO_SIDED|95.0|0.03|1.47||Adjusted for baseline: ppFEV1 (25%-50%, \>50%-75%, \>75%), azithromycin use (current vs. non-current), inhaled tobramycin type (powder vs. solution).|Regression, Linear|||||1.47|0.03|0.043
72505849|NCT03503773|144542862|SUPERIORITY||Mean Difference (Final Values)|-1.5||||0.2682|TWO_SIDED|95.0|-4.8|1.7|||ANCOVA||There was no formal hypothesis testing conducted in the study. 95% CIs are intended to be descriptive in nature only|The null hypothesis to be tested is that there is no difference in the change in 24 hour mean SBP between treatment and sham control. The Type I error rate for rejecting the null hypothesis will be set at an alpha level of 0.05.||1.7|-4.8|0.2682
72505850|NCT03503773|144542863|SUPERIORITY|||||||0.6964|||||||ANCOVA|||Difference between treatment arms||||0.6964
72395778|NCT02533427|144297768|OTHER||% GLSM Ratio|114.19|||||TWO_SIDED|90.0|107.4|121.39|||||Test/Reference: Norelgestromin Part B/Part A|Norelgestromin Part B/Part A||121.39|107.40|
72395779|NCT02533427|144297769|OTHER||% GLSM Ratio|121.62|||||TWO_SIDED|90.0|110.85|133.44|||||Test/Reference: Norgestrel Part B/Part A|Norgestrel Part B/Part A||133.44|110.85|
72395780|NCT02533427|144297770|OTHER||% GLSM Ratio|92.86|||||TWO_SIDED|90.0|82.55|104.45|||||Test/Reference: Ethinyl estradiol Part B/Part A|Ethinyl estradiol Part B/Part A||104.45|82.55|
72395781|NCT01124422|144297787|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-27.6|STANDARD_ERROR_OF_MEAN|20.58||0.181|TWO_SIDED|95.0|-68.2|13.0||ANCOVA model with terms for treatment, investigator, Oxycon stratum, and baseline value|ANCOVA|||||13.0|-68.2|0.181
72395782|NCT02959944|144297806|SUPERIORITY||Difference in Rates|0.043||||0.5384|TWO_SIDED|95.0|-0.094|0.181||P-value is computed using non-stratified Chi-Square test.|Chi-squared||Confidence interval is computed using normal approximation.|||0.181|-0.094|0.5384
72395783|NCT02959944|144297807|SUPERIORITY||Difference in Rates|0.043||||0.5384|TWO_SIDED|95.0|-0.094|0.181||P-value is computed using non-stratified Chi-Square test.|Chi-squared||Confidence interval is computed using normal approximation.|||0.181|-0.094|0.5384
72395784|NCT02959944|144297808|SUPERIORITY|||||||0.324||||||Gray's chi-square test (p-value) was calculated using SAS lifetest procedure adjusting for competing risks including death, cGVHD progression, relapse of underlying disease, and start of subsequent cGVHD therapy.|Chi-squared|||||||0.324
72395785|NCT02959944|144297809|SUPERIORITY|||||||0.281||||||Gray's chi-square test (p-value) was calculated using SAS lifetest procedure adjusting for competing risks including death, cGVHD progression, relapse of underlying disease, and start of subsequent cGVHD therapy.|Chi-squared|||||||0.281
72395786|NCT02959944|144297810|SUPERIORITY|||||||0.275||||||Gray's chi-square test (p-value) was calculated using SAS lifetest procedure adjusting for competing risks including death, cGVHD progression, relapse of underlying disease, and start of subsequent cGVHD therapy.|Chi-squared|||||||0.275
72505851|NCT03503773|144542864|SUPERIORITY|||||||0.0775|||||||ANCOVA|||Between group difference||||0.0775
72505852|NCT03503773|144542866|SUPERIORITY|||||||0.4734|||||||ANCOVA|||Between group difference||||0.4734
72505853|NCT03503773|144542868|SUPERIORITY|||||||0.0341|||||||ANCOVA|||||||0.0341
72505854|NCT03503773|144542870|SUPERIORITY||Mean Difference (Final Values)|-0.029||||0.573|TWO_SIDED|95.0|-0.132|0.073|||Fisher Exact|||||0.073|-0.132|0.573
72395787|NCT02959944|144297811|SUPERIORITY|||||||0.216||||||Gray's chi-square test (p-value) was calculated using SAS lifetest procedure adjusting for competing risks including death, cGVHD progression, relapse of underlying disease, and start of subsequent cGVHD therapy.|Chi-squared|||||||0.216
72395788|NCT02959944|144297812|SUPERIORITY||Difference in Rates|-0.067||||0.351|TWO_SIDED|95.0|-0.208|0.074||P-value was computed using non-stratified Chi-Square test.|Chi-squared||Confidence interval is computed using normal approximation.|||0.074|-0.208|0.3510
72395789|NCT02959944|144297813|SUPERIORITY||Difference in Rates|-0.067||||0.351|TWO_SIDED|95.0|-0.208|0.074||P-value was computed using non-stratified Chi-Square test.|Chi-squared||Confidence interval is computed using normal approximation.|||0.074|-0.208|0.3510
72395790|NCT02959944|144297814|SUPERIORITY||Difference in Rates|0.124||||0.0659|TWO_SIDED|95.0|-0.007|0.256||P-value is computed using non-stratified Chi-Square test.|Chi-squared||Confidence interval is computed using normal approximation.|||0.256|-0.007|0.0659
72395791|NCT02959944|144297815|SUPERIORITY||Difference in Rates|0.125||||0.0708|TWO_SIDED|95.0|-0.01|0.261||P-value is computed using non-stratified Chi-Square test.|Chi-squared|||||0.261|-0.010|0.0708
72395792|NCT02959944|144297816|SUPERIORITY||Difference in Rates|-0.059||||0.4064|TWO_SIDED|95.0|-0.199|0.08||P-value was computed using non-stratified Chi-Square test.|Chi-squared||Confidence interval was computed using normal approximation.|||0.080|-0.199|0.4064
72505855|NCT00514449|144542910|OTHER||number of voxels in a cluster|2037.0||||0.004|TWO_SIDED|||||p value is adjusted for multiple comparisons|ANCOVA||Time by treatment group interaction term|||||0.004
72505856|NCT00149825|144542928|SUPERIORITY_OR_OTHER|||||||0.13||95.0|||||Chi-squared|This is a one-tailed test||We hypothesized that compared with MED+CTRL, a greater percent of participants randomized to MED+CBTI will experience remission of depression||||.13
72505857|NCT00149825|144542929|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||Chi-squared|||We hypothesized that compared with MED+CTRL, a greater percent of participants in MED+CBTI will experience remission of insomnia.||||.05
72565634|NCT02709486|144662690|SUPERIORITY||Odds Ratio (OR)|2.06||||0.0002|TWO_SIDED|95.0|1.41|3.01|||Regression, Logistic|||Week 16: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.01|1.41|0.0002
72565635|NCT02709486|144662690|SUPERIORITY||Odds Ratio (OR)|1.78||||0.0022|TWO_SIDED|95.0|1.23|2.57|||Regression, Logistic|||Week 16: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment||2.57|1.23|0.0022
72565636|NCT02709486|144662690|SUPERIORITY||Odds Ratio (OR)|1.75||||0.0032|TWO_SIDED|95.0|1.21|2.54|||Regression, Logistic|||Week 24: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment||2.54|1.21|0.0032
72395793|NCT02959944|144297817|SUPERIORITY||Difference in Rates|-0.049||||0.4955|TWO_SIDED|95.0|-0.188|0.091||P-value was computed using non-stratified Chi-Square test.|Chi-squared||Confidence interval was computed using normal approximation.|||0.091|-0.188|0.4955
72395794|NCT02959944|144297818|SUPERIORITY||Hazard Ratio (HR)|0.994|||||TWO_SIDED|95.0|0.507|1.949|||||Hazard ratio is estimated using unstratified Cox regression model with treatment as the only covariate.|||1.949|0.507|
72395795|NCT02959944|144297819|SUPERIORITY||Hazard Ratio (HR)|1.061|||||TWO_SIDED|95.0|0.591|1.904|||||Hazard ratio is estimated using unstratified Cox regression model with treatment as the only covariate.|||1.904|0.591|
72395796|NCT02959944|144297820|SUPERIORITY||Hazard Ratio (HR)|0.697||||0.101|TWO_SIDED|95.0|0.451|1.076|||Regression, Cox|||||1.076|0.451|0.1010
72395797|NCT02959944|144297821|SUPERIORITY||Hazard Ratio (HR)|0.717||||0.1004|TWO_SIDED|95.0|0.482|1.068|||Regression, Cox|||||1.068|0.482|0.1004
72395798|NCT01830699|144297901|NON_INFERIORITY_OR_EQUIVALENCE|For details of power calculation, see above. Using a minimal clinical importance of -9.1, the null hypothesis was a mean difference less than -9.1.|Mean Difference (Final Values)|-23.9||||0.004|||||||t-test, 2 sided|||"Setting α=0.05 and β=0.8, with effect size of 0.17 anticipated total n = 138 to be recruited (requested recruitment of 150 to account for possible drop-outs)~1st data analysis (n = 33), effect size calculated at 1.1 with new n = 29 with α=0.05 and β=1.0."||||0.004
72395799|NCT01830699|144297902|NON_INFERIORITY_OR_EQUIVALENCE|See details above regarding effect size, power, etc.||||||0.044|||||||t-test, 2 sided|||"Setting α=0.05 and β=0.8, with effect size of 0.17 anticipated total n = 138 to be recruited (requested recruitment of 150 to account for possible drop-outs)~1st data analysis (n = 33), effect size calculated at 1.1 with new n = 29 with α=0.05 and β=1.0."||||0.044
72505858|NCT01208181|144542931|SUPERIORITY_OR_OTHER_LEGACY||Difference in least squares mean|-0.29||||0.004|TWO_SIDED|95.0|-0.49|-0.09|||Tukey-Ciminera-Heysetrend test|||||-0.09|-0.49|0.004
72505859|NCT01208181|144542931|SUPERIORITY_OR_OTHER_LEGACY||Difference in least squares mean|-0.27||||0.034|TWO_SIDED|95.0|-0.48|-0.06|||Tukey-Ciminera-Heysetrend test|||||-0.06|-0.48|0.034
72505860|NCT01208181|144542932|SUPERIORITY_OR_OTHER_LEGACY||Difference in least squares mean|-7.99|||<|0.001|TWO_SIDED|95.0|-11.85|-4.13|||Tukey-Ciminera-Heyse trend test|||||-4.13|-11.85|<0.001
72505861|NCT01208181|144542932|SUPERIORITY_OR_OTHER_LEGACY||Difference in least squares mean|-10.7|||<|0.001|TWO_SIDED|95.0|-14.74|-6.66|||Tukey-Ciminera-Heyse trend test|||||-6.66|-14.74|<0.001
72505862|NCT01208181|144542933|SUPERIORITY_OR_OTHER_LEGACY||Difference in least squares mean|0.02||||0.73|TWO_SIDED|95.0|-0.1|0.14|||Tukey-Ciminera-Heysetrend test|||||0.14|-0.10|0.730
72565637|NCT02709486|144662690|SUPERIORITY||Odds Ratio (OR)|1.85||||0.0013|TWO_SIDED|95.0|1.27|2.69|||Regression, Logistic|||Week 24: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment||2.69|1.27|0.0013
72395800|NCT01156311|144297927|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.92|||<|0.0001|TWO_SIDED|95.0|-1.17|-0.33|||Wilcoxon signed rank test||based on Hodges-Lehmann estimate|Change from average of Weeks -8, -4, and 0 to average of Weeks 16, 20, 24 MRI scans.||-0.33|-1.17|<0.0001
72395801|NCT01156311|144297927|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-1.17||||0.0124|TWO_SIDED|95.0|-1.83|-0.33|||Wilcoxon signed rank test||based on Hodges-Lehmann estimate|Change from average of Weeks -8, -4, and 0 to average of Weeks 16, 20, 24 MRI scans.||-0.33|-1.83|0.0124
72395802|NCT01156311|144297928|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.5||||0.001|TWO_SIDED|95.0|-1.5|-0.25|||Wilcoxon signed rank test||based on Hodges-Lehmann estimate|Change from average of Weeks -4, and 0 to average of Weeks 20, 24 MRI scans.||-0.25|-1.50|0.0010
72395803|NCT01156311|144297928|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.5||||0.0339|TWO_SIDED|95.0|-1.25|0.0|||Wilcoxon signed rank test||based on Hodges-Lehmann estimate|Change from average of Weeks -4, and 0 to average of Weeks 20, 24 MRI scans.||0.00|-1.25|0.0339
72395804|NCT01025791|144297932|OTHER||0.1 mg vs. placebo|-7.06||||0.003|TWO_SIDED|90.0|-11.1|-3.0|||ANOVA|||||-3.00|-11.1|0.003
72395805|NCT01025791|144297932|OTHER||0.2 mg vs. placebo|-1.23||||0.31|TWO_SIDED|90.0|-5.42|2.96|||ANOVA|||||2.96|-5.42|0.310
72395806|NCT01025791|144297932|OTHER||0.5 mg vs. placebo|0.01||||0.498|TWO_SIDED|90.0|-4.05|4.06|||ANOVA|||||4.06|-4.05|0.498
72565638|NCT02709486|144662692|SUPERIORITY||Odds Ratio (OR)|1.83||||0.0006|TWO_SIDED|95.0|1.3|2.59|||Regression, Logistic|||Week 2, \>=30%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.59|1.30|0.0006
72395807|NCT01025791|144297932|OTHER||1 mg vs. placebo|-5.69||||0.012|TWO_SIDED|90.0|-9.74|-1.63|||ANOVA|||||-1.63|-9.74|0.012
72395808|NCT01025791|144297932|OTHER||1 mg + 0.8 mg vs. placebo|-3.97||||0.059|TWO_SIDED|90.0|-8.16|0.22|||ANOVA|||||0.22|-8.16|0.059
72395809|NCT01025791|144297932|OTHER||0.4 mg vs. placebo|2.22||||0.191|TWO_SIDED|90.0|-2.09|6.54|||ANOVA|||||6.54|-2.09|0.191
72395810|NCT01025791|144297932|OTHER||1.2 mg vs. placebo|1.24||||0.333|TWO_SIDED|90.0|-3.67|6.15|||ANOVA|||||6.15|-3.67|0.333
72395811|NCT01025791|144297932|OTHER||1.2 mg + 0.6 mg vs. placebo|-1.43||||0.314|TWO_SIDED|90.0|-6.5|3.63|||ANOVA|||||3.63|-6.50|0.314
72395812|NCT01025791|144297932|OTHER||1 mg + 0.8 mg vs. placebo|-9.31||||0.001|TWO_SIDED|90.0|-14.2|-4.37|||ANOVA|||||-4.37|-14.2|0.001
72395813|NCT01025791|144297932|OTHER||1.2 mg + 1.0 mg vs. placebo|-6.45||||0.017|TWO_SIDED|90.0|-11.4|-1.51|||ANOVA|||||-1.51|-11.4|0.017
72395814|NCT01025791|144297932|OTHER||1.0 mg + 0.6 mg + 0.6 mg vs. placebo|-9.96||||0.001|TWO_SIDED|90.0|-14.9|-5.02|||ANOVA|||||-5.02|-14.9|0.001
72395815|NCT01025791|144297932|OTHER||1 mg + 1 mg + 0.6 mg vs. placebo|-9.0||||0.002|TWO_SIDED|95.0|-13.8|-4.17|||ANOVA|||||-4.17|-13.8|0.002
72395816|NCT01025791|144297937|OTHER||GMR (Fed/Fasted)|0.89|||||TWO_SIDED|95.0|0.86|0.92||||||||0.92|0.86|
72395817|NCT01025791|144297938|OTHER||GMR (Fed/fasted)|0.97|||||TWO_SIDED|95.0|0.79|1.19||||||||1.19|0.79|
72395818|NCT01025791|144297939|OTHER||0.1 mg vs placebo|-0.53||||0.396|TWO_SIDED|90.0|-3.92|2.86|||ANOVA|||||2.86|-3.92|0.396
72565639|NCT02709486|144662692|SUPERIORITY||Odds Ratio (OR)|1.53||||0.016|TWO_SIDED|95.0|1.08|2.16|||Regression, Logistic|||Week 2, \>=30%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.16|1.08|0.0160
72565640|NCT02709486|144662692|SUPERIORITY||Odds Ratio (OR)|2.03||||0.0008|TWO_SIDED|95.0|1.34|3.07|||Regression, Logistic|||Week 2, \>=50%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.07|1.34|0.0008
72565641|NCT02709486|144662692|SUPERIORITY||Odds Ratio (OR)|1.16||||0.5118|TWO_SIDED|95.0|0.75|1.8|||Regression, Logistic|||Week 2, \>=50%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||1.80|0.75|0.5118
72565642|NCT02709486|144662692|SUPERIORITY||Odds Ratio (OR)|2.45||||0.0093|TWO_SIDED|95.0|1.25|4.81|||Regression, Logistic|||Week 2, \>=70%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||4.81|1.25|0.0093
72565643|NCT02709486|144662692|SUPERIORITY||Odds Ratio (OR)|1.46||||0.3017|TWO_SIDED|95.0|0.71|3.01|||Regression, Logistic|||Week 2, \>=70%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.01|0.71|0.3017
72565644|NCT02709486|144662692|SUPERIORITY||Odds Ratio (OR)|2.4||||0.216|TWO_SIDED|95.0|0.6|9.58|||Regression, Logistic|||Week 2, \>=90%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||9.58|0.60|0.2160
72565645|NCT02709486|144662692|SUPERIORITY||Odds Ratio (OR)|1.33||||0.7174|TWO_SIDED|95.0|0.29|6.08|||Regression, Logistic|||Week 2, \>=90%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||6.08|0.29|0.7174
72565646|NCT02709486|144662692|SUPERIORITY||Odds Ratio (OR)|2.04|||<|0.0001|TWO_SIDED|95.0|1.45|2.87|||Regression, Logistic|||Week 4, \>=30%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.87|1.45|<.0001
72565647|NCT02709486|144662692|SUPERIORITY||Odds Ratio (OR)|1.81||||0.0006|TWO_SIDED|95.0|1.29|2.54|||Regression, Logistic|||Week 4, \>=30%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.54|1.29|0.0006
72622875|NCT01251757|144775933|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.5||||0.019|TWO_SIDED|95.0|-2.7|-0.2||As noted above, the a priori threshold for statistical significance for this test was .025.|Regression, Linear|adjusted for site, gender, age, total number of prescription medications participant is taking, comorbid diabetes/CVD, and baseline LDL group.|MeanLDL levels were sig lower for IVR+ participants than for UC participants. In subgroup analyses this difference was most pronounced in those individuals with baseline LDL levels above 100 mg/dL (adj diff=-3.6 mg/dL, 95%CI= (-5.9, -1.3), p=.002).|We conducted separate primary analyses of each of IVR and IVR+ versus usual care at the .025 level of significance to assure a trial-wide error rate of .05. This analysis summary is for the IVR+ versus UC comparison only. Also, we only report results here for the full sample, and not also separately for the 3 baseline LDL level subgroups.||-0.2|-2.7|.019
72622876|NCT01251757|144775934|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.03||||0.59|TWO_SIDED|95.0|0.93|1.13||As noted above, the a priori threshold for statistical significance for this test was .025.|Regression, Logistic|Adjusted for site, gender, age, total number of prescription medications participant is taking, comorbid diabetes/CVD, and baseline LDL group.||We conducted separate primary analyses of each of IVR and IVR+ versus usual care at the .025 level of significance to assure a trial-wide error rate of .05. This analysis summary is for the IVR versus UC comparison only. Also, we only report results here for the full sample, and not also separately for the 3 baseline LDL level subgroups.||1.13|0.93|.59
72622877|NCT01251757|144775934|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.1||||0.058|TWO_SIDED|95.0|1.0|1.22||As noted above, the a priori threshold for statistical significance for this test was .025.|Regression, Logistic|Adjusted for site, gender, age, total number of prescription medications participant is taking, comorbid diabetes/CVD, and baseline LDL group.|Though higher for the IVR+ group, LDL control did not differ significantly between the IVR+ and UC arms. Among those with poor initial control, however, control was sig better for the IVR+ arm (OR = 1.21, 95%CI = (1.04, 1.42), p=.015).|We conducted separate primary analyses of each of IVR and IVR+ versus usual care at the .025 level of significance to assure a trial-wide error rate of .05. This analysis summary is for the IVR+ versus UC comparison only. Also, we only report results here for the full sample, and not also separately for the 3 baseline LDL level subgroups.||1.22|1.00|.058
72622878|NCT02796651|144775943|SUPERIORITY||LSMean difference|0.108|||<|0.001|TWO_SIDED|95.0|0.055|0.161|||Mixed Models Analysis|||||0.161|0.055|<0.001
72622879|NCT02796651|144775943|SUPERIORITY||LSMean difference|0.117|||<|0.001|TWO_SIDED|95.0|0.064|0.171|||Mixed Models Analysis|||||0.171|0.064|<0.001
72395819|NCT01025791|144297939|OTHER||0.2 mg vs. placebo|2.33||||0.1329|TWO_SIDED|90.0|-1.17|5.83|||ANOVA|||||5.83|-1.17|0.1329
72395820|NCT01025791|144297939|OTHER||0.5mg vs. placebo|-2.96||||0.0741|TWO_SIDED|90.0|-6.35|0.43|||ANOVA|||||0.43|-6.35|0.0741
72395821|NCT01025791|144297939|OTHER||1 mg vs. placebo|7.08|||<|0.001|TWO_SIDED|90.0|3.69|10.47|||ANOVA|||||10.47|3.69|<0.001
72395822|NCT01025791|144297939|OTHER||1 mg + 0.8 mg vs. placebo|4.39||||0.0211|TWO_SIDED|90.0|0.89|7.09|||ANOVA|||||7.09|0.89|0.0211
72395823|NCT01025791|144297939|OTHER||0.4 mg vs. placebo|0.85||||0.399|TWO_SIDED|90.0|-4.79|6.48|||ANOVA|||||6.48|-4.79|0.399
72505863|NCT01208181|144542934|SUPERIORITY_OR_OTHER_LEGACY||Difference in least squares mean|-2.71||||0.019|TWO_SIDED|95.0|-4.98|-0.45|||Tukey-Ciminera-Heyse trend test|||||-0.45|-4.98|0.019
72505864|NCT01208181|144542935|SUPERIORITY_OR_OTHER_LEGACY||Difference in the least squares mean|1.61||||0.327|TWO_SIDED|80.0|-0.49|3.71|||covariance model|||||3.71|-0.49|0.327
72505865|NCT00942708|144542938|OTHER|Single group evaluation of change in PVR between 12 weeks and baseline (T-test for one group, 2-sided, p\<0.05 considered significant)||||||0.09|||||||t-test, 1 sided|||||||0.09
72505866|NCT03694522|144543062|SUPERIORITY||Hazard Ratio (HR)|0.68||||0.0727|TWO_SIDED|95.0|0.44|1.04|||Stratified log-rank test|Adjusted for randomization stratification factors of geographic region and administration of mFOLFOX6 single dose prior to randomization.|Hazard ratio and 95% CIs were calculated using the Cox proportional hazards model, adjusted for randomization stratification factors, including geographic region and administration of mFOLFOX6 single dose prior to randomization.|||1.04|0.44|0.0727
72505867|NCT03694522|144543063|SUPERIORITY||Hazard Ratio (HR)|0.58||||0.0268|TWO_SIDED|95.0|0.35|0.95|||Stratified log-rank test|Adjusted for randomization stratification factors, including geographic region and administration of mFOLFOX6 single dose prior to randomization.|Hazard ratio and 95% CIs were calculated using the Cox proportional hazards model, adjusted for randomization stratification factors, including geographic region and administration of mFOLFOX6 single dose prior to randomization.|||0.95|0.35|0.0268
72505868|NCT03694522|144543064|SUPERIORITY||Difference|13.1||||0.106|TWO_SIDED|95.0|-2.8|29.0|||Cochran-Mantel-Haenszel|P-value was calculated based on stratum-adjusted Cochran-Mantel-Haenszel (CMH) proportions||||29.0|-2.8|0.1060
72505869|NCT03694522|144543066|SUPERIORITY||Hazard Ratio (HR)|0.6|||||TWO_SIDED|95.0|0.38|0.94|||||Hazard ratio and 95% CIs were calculated using the Cox proportional hazards model, adjusted for randomization stratification factors, including geographic region and administration of mFOLFOX6 single dose prior to randomization.|||0.94|0.38|
72622880|NCT02796651|144775943|SUPERIORITY||LSMean difference|0.162|||<|0.001|TWO_SIDED|95.0|0.107|0.216|||Mixed Models Analysis|||||0.216|0.107|<0.001
72622881|NCT02796651|144775943|SUPERIORITY||LSMean difference|0.122|||<|0.001|TWO_SIDED|95.0|0.069|0.175|||Mixed Models Analysis|||||0.175|0.069|<0.001
72622882|NCT02796651|144775943|SUPERIORITY||LSMean difference|0.009||||0.556|TWO_SIDED|95.0|-0.021|0.039|||Mixed Models Analysis|||||0.039|-0.021|0.556
72622883|NCT02796651|144775943|SUPERIORITY||LSMean difference|0.053||||0.001|TWO_SIDED|95.0|0.021|0.085|||Mixed Models Analysis|||||0.085|0.021|0.001
72622884|NCT02796651|144775943|SUPERIORITY||LSMean difference|0.014||||0.365|TWO_SIDED|95.0|-0.016|0.044|||Mixed Models Analysis|||||0.044|-0.016|0.365
72395824|NCT01025791|144297939|OTHER||1.2 mg vs. placebo|4.54||||0.1|TWO_SIDED|90.0|-1.94|11.02|||ANOVA|||||11.02|-1.94|0.100
72395825|NCT01025791|144297939|OTHER||1.2 mg + 0.6 mg vs. placebo|3.38||||0.195|TWO_SIDED|90.0|-3.29|10.06|||ANOVA|||||10.06|-3.29|0.195
72395826|NCT01025791|144297939|OTHER||1.0 mg + 0.8 mg vs. placebo|9.16||||0.022|TWO_SIDED|90.0|1.74|16.58|||ANOVA|||||16.58|1.74|0.022
72395827|NCT01025791|144297939|OTHER||1.2 mg + 1.0 mg vs. placebo|5.74||||0.098|TWO_SIDED|90.0|-1.68|13.16|||ANOVA|||||13.16|-1.68|0.098
72395828|NCT01025791|144297939|OTHER||1 mg + 0.6 mg + 0.6 mg vs. placebo|3.48||||0.214|TWO_SIDED|90.0|-3.94|10.9|||ANOVA|||||10.90|-3.94|0.214
72395829|NCT01025791|144297939|OTHER||1 mg + 1 mg + 0.6 mg vs. placebo|4.24||||0.163|TWO_SIDED|95.0|-3.03|11.52|||ANOVA|||||11.52|-3.03|0.163
72395830|NCT01574326|144297946|SUPERIORITY_OR_OTHER||Least square (LS) mean difference|-0.9||||0.001|TWO_SIDED|95.0|-1.44|-0.37|||ANCOVA|Threshold for significance ≤ 0.05.||Primary efficacy endpoint, change from baseline to Week 2 in serum phosphorus, was compared between treatment groups using analysis of covariance (ANCOVA) with baseline phosphorus and screening BSA as covariates and fixed effect for treatment. No center effect was included in the model. The estimate of the treatment difference (Sevelamer Carbonate - Placebo) and its 95% CI were presented. Significance was to be declared if the p-value was ≤0.05.||-0.37|-1.44|0.001
72395831|NCT04044716|144297954|SUPERIORITY|||||||0.048|||||||ANCOVA|age, joint involved in surgery, sex, baseline pain||||||.048
72395832|NCT04044716|144297955|SUPERIORITY|||||||0.29|||||||ANCOVA|adjusted for age, sex, type of surgery (joint), baseline pain||||||0.29
72395833|NCT04044716|144297956|SUPERIORITY|||||||0.64|||||||ANCOVA|adjusted for age, sex, type of surgery (joint), baseline morphine milligram equivalents (MME)||||||0.64
72395834|NCT04044716|144297957|SUPERIORITY|||||||0.86|||||||ANCOVA|adjusted for age, sex, type of surgery (joint), baseline MME, and time in hospital||||||0.86
72395835|NCT04044716|144297958|SUPERIORITY|||||||0.661||||||adjusted for age, type of surgery (joint), and sex|ANCOVA|||||||0.661
72395836|NCT01018186|144297983|SUPERIORITY_OR_OTHER||Ratio|1.67|||||TWO_SIDED|95.0|1.34|2.08|||||Ratio of FF/VI 100/25 OD versus FP 500 BD to Baseline of 24-Hour Urinary Cortisol Excretion at Week 12|||2.08|1.34|
72395837|NCT01018186|144297983|SUPERIORITY_OR_OTHER||Ratio|1.65|||||TWO_SIDED|95.0|1.29|2.13|||||Ratio of FF/VI 100/25 OD versus FP 500 BD to Baseline of 24-Hour Urinary Cortisol Excretion at Week 28|||2.13|1.29|
72565648|NCT02709486|144662692|SUPERIORITY||Odds Ratio (OR)|1.81||||0.0024|TWO_SIDED|95.0|1.23|2.65|||Regression, Logistic|||Week 4, \>=50%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.65|1.23|0.0024
72395838|NCT01018186|144297983|SUPERIORITY_OR_OTHER||Ratio|1.05|||||TWO_SIDED|95.0|0.83|1.33|||||Ratio of FF/VI 100/25 OD versus FP 500 BD to Baseline of 24-Hour Urinary Cortisol Excretion at Week 52|||1.33|0.83|
72395839|NCT01018186|144297983|SUPERIORITY_OR_OTHER||Ratio|1.52|||||TWO_SIDED|95.0|1.22|1.89|||||Ratio of FF/VI 200/25 OD versus FP 500 BD to Baseline of 24-Hour Urinary Cortisol Excretion at Week 12|||1.89|1.22|
72395840|NCT01018186|144297983|SUPERIORITY_OR_OTHER||Ratio|1.43|||||TWO_SIDED|95.0|1.11|1.84|||||Ratio of FF/VI 200/25 OD versus FP 500 BD to Baseline of 24-Hour Urinary Cortisol Excretion at Week 28|||1.84|1.11|
72395841|NCT01018186|144297983|SUPERIORITY_OR_OTHER||Ratio|1.09|||||TWO_SIDED|95.0|0.87|1.38|||||Ratio of FF/VI 200/25 OD versus FP 500 BD to Baseline of 24-Hour Urinary Cortisol Excretion at Week 52|||1.38|0.87|
72395842|NCT01018186|144297984|SUPERIORITY_OR_OTHER||Ratio of LSGM to Baseline|1.67|||<|0.001|TWO_SIDED|95.0|1.34|2.08|||ANCOVA|||||2.08|1.34|<0.001
72395843|NCT01018186|144297984|SUPERIORITY_OR_OTHER||Ratio of LSGM to Baseline|1.52|||<|0.001|TWO_SIDED|95.0|1.22|1.89|||ANCOVA|||||1.89|1.22|<0.001
72395844|NCT01018186|144297985|SUPERIORITY_OR_OTHER||Ratio of LSGM to Baseline|1.65|||<|0.001|TWO_SIDED|95.0|1.29|2.13|||ANCOVA|||||2.13|1.29|<0.001
72395845|NCT01018186|144297985|SUPERIORITY_OR_OTHER||Ratio of LSGM to Baseline|1.43||||0.006|TWO_SIDED|95.0|1.11|1.84|||ANCOVA|||||1.84|1.11|0.006
72395846|NCT01018186|144297986|SUPERIORITY_OR_OTHER||Ratio of LSGM to Baseline|1.05||||0.674|TWO_SIDED|95.0|0.83|1.33|||ANCOVA|||||1.33|0.83|0.674
72395847|NCT01018186|144297986|SUPERIORITY_OR_OTHER||Ratio of LSGM to Baseline|1.09||||0.444|TWO_SIDED|95.0|0.87|1.38|||ANCOVA|||||1.38|0.87|0.444
72395848|NCT03552198|144298003|OTHER|||||||0.964|||||||ANCOVA|ANCOVA, adjusted for baseline measures, tested for differences between intervention and control groups in preventative behaviours at 4 weeks||We predicted that the groups receiving the alternative format of air quality notifications would report greater frequency of behaviour change at 4 weeks compared to the groups receiving the usual format.||||.964
72395849|NCT03552198|144298004|OTHER|||||||0.043|||||||Chi-squared|χ2(1)=4.11, V=0.229||We predicted that more respondents in the intervention groups (i.e. receiving alternative health advice) would consider making permanent changes to their daily travel route, exercise location or exercise time compared to the control groups||||0.043
72395850|NCT03552198|144298005|OTHER||||||>|0.05|||||||Fisher Exact|||We predicted that the alternative health advice would lead to greater actual behaviour change compared to the usual format||||>0.05
72395851|NCT03552198|144298006|OTHER||||||>|0.05|||||||ANCOVA|ANCOVA, adjusted for baseline intentions, tested for differences between groups in intentions in relation to an high-air-pollution scenario at 4 weeks||We predicted that the alternative format would lead to stronger intentions to adhere to recommendations associated with an hypothetical high air pollution episode compared to the usual format.||||>0.05
72395852|NCT03235154|144298009|OTHER|There was no comparator arm in this small single arm study||||||||||||No confidence intervals around point estimates provided given very small number of participants||||This was a single arm intervention study with a very small number of participants. Therefore, only descriptive statistics are provided.|No confidence intervals around point estimates provided given very small number of participants|||
72395853|NCT02326025|144298010|SUPERIORITY||Ratio of Geometric LS Means|1.04|||||TWO_SIDED|90.0|0.964|1.13|||||Log(PK) is participant and treatment and random error, where participant is fitted as a random effect.|||1.13|0.964|
72395854|NCT02326025|144298010|SUPERIORITY||Ratio of LS Means|1.03|||||TWO_SIDED|90.0|0.957|1.11||||||||1.11|0.957|
72395855|NCT02326025|144298011|SUPERIORITY||Ratio of LS Means|0.944|||||TWO_SIDED|90.0|0.77|1.16||||||||1.16|0.770|
72395856|NCT02326025|144298011|SUPERIORITY||Ratio of LS Means|1.03|||||TWO_SIDED|90.0|0.801|1.33||||||||1.33|0.801|
72395857|NCT00001723|144298018|SUPERIORITY_OR_OTHER|||||||0.007||95.0|||||ANCOVA|||||||0.007
72395858|NCT02643082|144298023|SUPERIORITY||LS Mean ratio between treatments|1.75|||<|0.0001|TWO_SIDED|95.0|1.65|1.86|||Mixed Models Analysis|||||1.86|1.65|<0.0001
72395859|NCT02643082|144298024|SUPERIORITY||LS Mean ratio between treatments|0.29|||<|0.0001|TWO_SIDED|95.0|0.26|0.33|||Mixed Models Analysis|||||0.33|0.26|<0.0001
72395860|NCT02643082|144298025|SUPERIORITY||LS Mean ratio between treatments|0.29|||<|0.0001|TWO_SIDED|95.0|0.25|0.33|||Mixed Models Analysis|||||0.33|0.25|<0.0001
72622885|NCT02796651|144775943|SUPERIORITY||LSMean difference|0.044||||0.006|TWO_SIDED|95.0|0.013|0.076|||Mixed Models Analysis|||||0.076|0.013|0.006
72505870|NCT01164501|144543067|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.51|STANDARD_ERROR_OF_MEAN|0.06|<|0.0001|TWO_SIDED|95.0|-0.62|-0.39||Hierarchical testing to adjust for multiple comparisons, no adjustment in p-values. Empa 25 mg versus placebo in mild or moderate renal impaired patients was the first step in the hierarchical sequence.|ANCOVA|Based on ANCOVA with terms for treatment, background antidiabetic medication, renal impairment and baseline HbA1c.|Difference calculated as empa 25mg minus placebo|||-0.39|-0.62|<0.0001
72505871|NCT01164501|144543068|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.52|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001|TWO_SIDED|95.0|-0.72|-0.32||Hierarchical testing to adjust for multiple comparisons, no adjustment in p-values. Empa 25 mg versus placebo in mild renal impaired patients was the second step in the hierarchical sequence.|ANCOVA|Based on ANCOVA with terms for treatment, background antidiabetic medication and baseline HbA1c.|Difference calculated as empa 10mg minus placebo|||-0.32|-0.72|<0.0001
72505872|NCT01164501|144543068|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.68|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001|TWO_SIDED|95.0|-0.88|-0.49||Hierarchical testing to adjust for multiple comparisons, no adjustment in p-values. Empa 10 mg versus placebo in mild renal impaired patients was the third step in the hierarchical sequence.|ANCOVA|Based on ANCOVA with terms for treatment, background antidiabetic medication and baseline HbA1c.|Difference calculated as empa 25mg minus placebo|||-0.49|-0.88|<0.0001
72505873|NCT01164501|144543069|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.42|STANDARD_ERROR_OF_MEAN|0.07|<|0.0001|TWO_SIDED|95.0|-0.56|-0.28||Hierarchical testing to adjust for multiple comparisons, no adjustment in p-values. Empa 10 mg versus placebo in moderate renal impaired patients was the fourth step in the hierarchical sequence.|ANCOVA|Based on ANCOVA with terms for treatment, background antidiabetic medication and baseline HbA1c.|Difference calculated as empa 25mg minus placebo|||-0.28|-0.56|<0.0001
72505874|NCT04799782|144543088|SUPERIORITY|||||||0.015|||||||t-test, 2 sided|||||||0.015
72505875|NCT04799782|144543089|SUPERIORITY|||||||0.82|||||||t-test, 2 sided|||||||0.82
72505876|NCT02606877|144543090|OTHER||T1/R1 Ratio (%)|88.58|STANDARD_DEVIATION|45.1|||TWO_SIDED|90.0|65.4|119.97|||ANOVA|The analysis of variance (ANOVA) model on a logarithmic scale including effects: 'subject' and 'treatment'.|To get,geometric mean ratio and Confidence Interval,least square estimates of log-transformed PK endpoint for T1 and R1 were back transformed to original scale. Standard Deviation is actually the intra-individual geometric Coefficient of Variance(%).|||119.97|65.40|
72505877|NCT02606877|144543091|OTHER||T1/R1 Ratio (%)|80.63|STANDARD_DEVIATION|74.6|||TWO_SIDED|90.0|51.27|126.79|||ANOVA|The analysis of variance (ANOVA) model on a logarithmic scale including effects: 'subject' and 'treatment'.|To get,geometric mean ratio and Confidence Interval,least square estimates of log-transformed PK endpoint for T1 and R1 were back transformed to original scale. Standard Deviation is actually the intra-individual geometric Coefficient of Variance(%).|||126.79|51.27|
72505878|NCT02606877|144543092|OTHER||T2/R2 Ratio (%)|97.17|STANDARD_DEVIATION|14.1|||TWO_SIDED|90.0|87.84|107.48|||ANOVA|The analysis of variance (ANOVA) model on a logarithmic scale including effects: 'subject' and 'treatment'.|To get,geometric mean ratio and Confidence Interval,least square estimates of log-transformed PK endpoint for T2 and R2 were back transformed to original scale. Standard Deviation is actually the intra-individual geometric Coefficient of Variance(%).|||107.48|87.84|
72505879|NCT02606877|144543093|OTHER||T2/R2 Ratio (%)|99.49|STANDARD_DEVIATION|17.4|||TWO_SIDED|90.0|87.94|112.56|||ANOVA|The analysis of variance (ANOVA) model on a logarithmic scale including effects: 'subject' and 'treatment'.|To get,geometric mean ratio and Confidence Interval,least square estimates of log-transformed PK endpoint for T2 and R2 were back transformed to original scale. Standard Deviation is actually the intra-individual geometric Coefficient of Variance(%).|||112.56|87.94|
72565649|NCT02709486|144662692|SUPERIORITY||Odds Ratio (OR)|2.17|||<|0.0001|TWO_SIDED|95.0|1.49|3.16|||Regression, Logistic|||Week 4, \>=50%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.16|1.49|<.0001
72505880|NCT02606877|144543094|OTHER||T1/R1 Ratio (%)|89.49|STANDARD_DEVIATION|44.3|||TWO_SIDED|90.0|66.33|120.73|||ANOVA|The analysis of variance (ANOVA) model on a logarithmic scale including effects: 'subject' and 'treatment'.|To get,geometric mean ratio and Confidence Interval,least square estimates of log-transformed PK endpoint for T1 and R1 were back transformed to original scale. Standard Deviation is actually the intra-individual geometric Coefficient of Variance(%).|||120.73|66.33|
72565650|NCT02709486|144662692|SUPERIORITY||Odds Ratio (OR)|1.8||||0.0373|TWO_SIDED|95.0|1.04|3.14|||Regression, Logistic|||Week 4, \>=70%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.14|1.04|0.0373
72395861|NCT02643082|144298026|SUPERIORITY||LS Mean ratio between treatments|1.79|||<|0.0001|TWO_SIDED|95.0|1.67|1.92|||Mixed Models Analysis|||||1.92|1.67|<0.0001
72395862|NCT02643082|144298027|SUPERIORITY||LS Mean Difference Between Treatments|0.443|||<|0.0001|TWO_SIDED|95.0|0.318|0.569|||Mixed Models Analysis|||||0.569|0.318|<0.0001
72505881|NCT02989727|144543106|SUPERIORITY||ANOVA estimate|1.88|STANDARD_ERROR_OF_MEAN|3.51||0.59|TWO_SIDED||||||ANOVA|||Weighted ANOVA models were used to compare change scores between lamotrigine and placebo groups while testing for interactions by melancholic status. The estimate and test reported is for the the interaction between treatment condition and melancholic status.||||.59
72505882|NCT02989727|144543107|SUPERIORITY||ANOVA estimate|0.5|STANDARD_ERROR_OF_MEAN|2.56||0.84|TWO_SIDED||||||ANOVA|||Weighted ANOVA models were used to compare change scores between lamotrigine and placebo groups while testing for interactions by melancholic status. The estimate and test reported is for the the interaction between treatment condition and melancholic status.||||.84
72505883|NCT02989727|144543108|SUPERIORITY||Cox Proportional Hazard|1.2|STANDARD_ERROR_OF_MEAN|0.1||0.08|TWO_SIDED||||||Regression, Cox|||"Weighted Cox regression with treatment condition (lamotrigine vs. placebo) predicting treatment response. Response is defined as a score reduction of at least 50% from baseline. The outcome variable is binary coded with 1 being a response at anytime point and 0 indicating no response."||||.08
72565651|NCT02709486|144662692|SUPERIORITY||Odds Ratio (OR)|2.17||||0.0046|TWO_SIDED|95.0|1.27|3.72|||Regression, Logistic|||Week 4, \>=70%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.72|1.27|0.0046
72395863|NCT02643082|144298028|SUPERIORITY||LS Mean ratio between treatments|0.87|||<|0.0001|TWO_SIDED|95.0|0.82|0.92|||Mixed Models Analysis|||||0.92|0.82|<0.0001
72395864|NCT01324999|144298029|OTHER|||||||0.68|||||||t-test, 2 sided|||Comparing baseline to week 24.||||0.68
72395865|NCT01324999|144298030|OTHER|||||||0.34|||||||t-test, 2 sided|||||||0.34
72395866|NCT01324999|144298031|OTHER|||||||0.99|||||||t-test, 2 sided|||||||0.99
72395867|NCT01324999|144298032|OTHER|||||||0.19|||||||t-test, 2 sided|||comparing baseline to week 24||||0.19
72395868|NCT01324999|144298033|OTHER|||||||0.68|||||||t-test, 2 sided|||Comparing Baseline to week 24.||||0.68
72471474|NCT02358668|144466641|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.16||||0.03|TWO_SIDED|95.0|-0.31|-0.02||The p-value of treatment effects (reference to placebo) were obtained by mixed effect model analysis comparing the outcome values adjusted with repeated measures, ages and gender.|Mixed Models Analysis|||||-0.02|-0.31|0.03
72471475|NCT02358668|144466641|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.01||||0.87|TWO_SIDED|95.0|-0.13|0.15||The p-value of treatment effects (reference to placebo) were obtained by mixed effect model analysis comparing the outcome values adjusted with repeated measures, ages and gender.|Mixed Models Analysis|||||0.15|-0.13|0.87
72395869|NCT01324999|144298034|OTHER|||||||0.92|||||||t-test, 2 sided|||comparing baseline to week 24||||0.92
72395870|NCT01324999|144298035|OTHER|||||||0.44|||||||t-test, 2 sided|||comparison of baseline to week 24||||0.44
72395871|NCT03178903|144298050|SUPERIORITY||Mean Difference (Final Values)|0.678||||0.87|TWO_SIDED|||||p\<.05 was the a priori threshold for statistical significance.|ANCOVA|Covarying for baseline depressive symptoms and MVPA.||||||.87
72471476|NCT02358668|144466642|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.48||||0.34|TWO_SIDED|95.0|-1.46|0.5||The p-value of treatment effects (reference to placebo) were obtained by mixed effect model analysis comparing the outcome values adjusted with repeated measures, ages and gender.|Mixed Models Analysis|||||0.50|-1.46|0.34
72505884|NCT02989727|144543108|SUPERIORITY||Cox Proportional Hazard|1.08|STANDARD_ERROR_OF_MEAN|0.12||0.53|TWO_SIDED||||||Regression, Cox|||"Weighted Cox regression with treatment condition (lamotrigine vs. placebo) predicting treatment response. Response is defined as a score reduction of at least 50% from baseline. The outcome variable is binary coded with 1 being a response at anytime point and 0 indicating no response."||||.53
72395872|NCT00060008|144298051|SUPERIORITY_OR_OTHER|||||||0.016|||||||Wilcoxon (Mann-Whitney)|||||||0.016
72395873|NCT02848651|144298148|SUPERIORITY||Hazard Ratio (HR)|0.8||||0.3502|TWO_SIDED|90.0|0.54|1.18|||Log Rank|||||1.18|0.54|0.3502
72471477|NCT02358668|144466642|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.22||||0.64|TWO_SIDED|95.0|-0.73|1.18||The p-value of treatment effects (reference to placebo) were obtained by mixed effect model analysis comparing the outcome values adjusted with repeated measures, ages and gender.|Mixed Models Analysis|||||1.18|-0.73|0.64
72622886|NCT02796651|144775943|SUPERIORITY||LSMean difference|0.005||||0.756|TWO_SIDED|95.0|-0.026|0.036|||Mixed Models Analysis|||||0.036|-0.026|0.756
72622887|NCT02796651|144775943|SUPERIORITY||LSMean difference|-0.039||||0.014|TWO_SIDED|95.0|-0.071|-0.008|||Mixed Models Analysis|||||-0.008|-0.071|0.014
72395874|NCT02848651|144298155|SUPERIORITY||Hazard Ratio (HR)|0.66||||0.1783|TWO_SIDED|90.0|0.4|1.1|||Log Rank|||||1.10|0.40|0.1783
72395875|NCT02848651|144298155|SUPERIORITY||Hazard Ratio (HR)|0.44||||0.0358|TWO_SIDED|90.0|0.23|0.85|||Log Rank|||||0.85|0.23|0.0358
72395876|NCT02848651|144298156|SUPERIORITY||Differences in Rates|13.27||||0.0326|TWO_SIDED|90.0|2.53|24.0|||Cochran-Mantel-Haenszel|||||24.00|2.53|0.0326
72395877|NCT02848651|144298156|SUPERIORITY||Difference in Rates|30.22|||<|0.0001|TWO_SIDED|90.0|14.82|45.62|||Cochran-Mantel-Haenszel|||||45.62|14.82|<0.0001
72395878|NCT02848651|144298156|SUPERIORITY||Differences in Rates|41.37|||<|0.0001|TWO_SIDED|90.0|22.13|60.61|||Cochran-Mantel-Haenszel|||||60.61|22.13|<0.0001
72395879|NCT00662363|144298178|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||independent sample t test|||Primary outcome measures chosen were between group comparisons for change on Constipation Symptom Questionnaire ratings at exit from the study. The PAC-SYM is a symptom scale where higher numbers indicate more symptoms. Change from baseline to Day 7 was calculated and larger negative differences indicated greater improvement in constipation symptoms. The PAC-QOL is a quality of life scale where higher numbers indicate better quality of life. Change from baseline to 7 days was calculated.||||<0.05
72395880|NCT01428453|144298180|SUPERIORITY_OR_OTHER||Mean Difference (Net)|39.8||||0.133|TWO_SIDED|95.0|-12.4|92.0|||ANCOVA|The analysis method was ANCOVA adjusted for Treatment, Baseline CSF Abeta1-42 and Age.|Comparison of CSF Abeta42 between placebo and rilapladib 250 mg.|||92.0|-12.4|0.133
72395881|NCT01428453|144298180|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-250.3|STANDARD_ERROR_OF_MEAN|265.66||0.829|TWO_SIDED|95.0|-771.9|271.2|||ANCOVA|The analysis method was ANCOVA adjusted for Treatment, Baseline CSF Abeta1-40 and Age.|Comparison of CSF Abeta40 between placebo and rilapladib 250 mg.|||271.2|-771.9|0.829
72395882|NCT01428453|144298181|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.016|||||TWO_SIDED|95.0|-0.003|0.036|||||The analysis method was ANCOVA adjusted for Treatment, Baseline CSF Ratio Abeta1-42/Abeta1-40 and Age.|||0.036|-0.003|
72395883|NCT01428453|144298182|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-57.1|STANDARD_ERROR_OF_MEAN|44.4||0.902|TWO_SIDED|95.0|-144.5|30.3|||ANCOVA|The analysis method was ANCOVA adjusted for Treatment, Baseline CSF tau and Age.|Comparison of CSF tau between placebo and rilapladib 250 mg.|||30.3|-144.5|0.902
72505885|NCT02989727|144543116|SUPERIORITY||Cox Proportional Hazard|1.27|STANDARD_ERROR_OF_MEAN|0.11||0.02|TWO_SIDED||||||Regression, Cox|||"Weighted Cox regression with treatment condition (lamotrigine vs. placebo) predicting treatment response. Response is defined as a score reduction of at least 50% from baseline. The outcome variable is binary coded with 1 being a response at any time point and 0 indicating no response."||||.02
72505886|NCT02989727|144543116|SUPERIORITY||Cox Proportional Hazard|1.05|STANDARD_ERROR_OF_MEAN|0.13||0.73|TWO_SIDED||||||Regression, Cox|||"Weighted Cox regression with treatment condition (lamotrigine vs. placebo) predicting treatment response. Response is defined as a score reduction of at least 50% from baseline. The outcome variable is binary coded with 1 being a response at any time point and 0 indicating no response."||||.73
72505887|NCT00515463|144543129|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.0||||||95.0|-0.7|0.7|||||Risk difference \> 0 indicates that incidence of binding anti-denosumab antibodies in denosumab PFS is greater than denosumab vial. 95% CI based on a normal approximation with continuity correction.|||0.7|-0.7|
72505888|NCT00515463|144543130|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.0||||||95.0|-0.7|0.7||||||||0.7|-0.7|
72395884|NCT01428453|144298182|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.0|STANDARD_ERROR_OF_MEAN|2.46||0.892|TWO_SIDED|95.0|-7.9|1.8|||ANCOVA|The analysis method was ANCOVA adjusted for Treatment, Baseline CSF P-tau and Age.|Comparison of P-tau between placebo and rilapladib 250 mg.|||1.8|-7.9|0.892
72395885|NCT01428453|144298183|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.167||||0.026|TWO_SIDED|95.0|0.021|0.313||The analysis method was Mixed-Model Repeated Measures adjusted for Treatment, Visit, Baseline Working Memory/Executive Function Composite Score, Treatment by Visit and Baseline Working Memory/Executive Function Composite Score by Visit.|Mixed-Model Repeated Measures analysis||A positive treatment difference indicates benefit, relative to placebo.|||0.313|0.021|0.026
72395886|NCT01428453|144298184|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.24|STANDARD_ERROR_OF_MEAN|0.256||0.828|TWO_SIDED|95.0|-0.74|0.26|||ANCOVA|The analysis method was ANCOVA adjusted for Treatment, Baseline CSF Albumin Quotient and Age.||||0.26|-0.74|0.828
72395887|NCT01428453|144298185|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.3|||||TWO_SIDED|95.0|-3.9|1.2|||Mixed-Model Repeated Measures analysis||Comparison of Abeta42 between placebo and rilapladib 250 mg. The analysis method for Plasma parameters was Mixed-Model Repeated Measures adjusted for Treatment, Visit, Baseline, Treatment by Visit, Baseline by Visit and Age.|||1.2|-3.9|
72471478|NCT02358668|144466643|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.62||||0.17|TWO_SIDED|95.0|-1.5|0.26||The p-value of treatment effects (reference to placebo) were obtained by mixed effect model analysis comparing the outcome values adjusted with repeated measures, ages and gender.|Mixed Models Analysis|||||0.26|-1.50|0.17
72622888|NCT02796651|144775944|SUPERIORITY||LSMean difference|0.13|||<|0.001|TWO_SIDED|95.0|0.091|0.169|||Mixed Models Analysis|||||0.169|0.091|<0.001
72471479|NCT02358668|144466643|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.39||||0.37|TWO_SIDED|95.0|-0.46|1.24||The p-value of treatment effects (reference to placebo) were obtained by mixed effect model analysis comparing the outcome values adjusted with repeated measures, ages and gender.|Mixed Models Analysis|||||1.24|-0.46|0.37
72471480|NCT02358668|144466644|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.65||||0.18|TWO_SIDED|95.0|-1.62|0.31||The p-value of treatment effects (reference to placebo) were obtained by mixed effect model analysis comparing the outcome values adjusted with repeated measures, ages and gender.|Mixed Models Analysis|||||0.31|-1.62|0.18
72471481|NCT02358668|144466644|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.42||||0.37|TWO_SIDED|95.0|-0.51|1.36||The p-value of treatment effects (reference to placebo) were obtained by mixed effect model analysis comparing the outcome values adjusted with repeated measures, ages and gender.|Mixed Models Analysis|||||1.36|-0.51|0.37
72471482|NCT02358668|144466645|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.14||||0.06|TWO_SIDED|95.0|-4.36|0.09||The p-value of treatment effects (reference to placebo) were obtained by mixed effect model analysis comparing the outcome values adjusted with repeated measures, ages and gender.|Mixed Models Analysis|||||0.09|-4.36|0.06
72471483|NCT02358668|144466645|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.43||||0.69|TWO_SIDED|95.0|-1.71|2.58||The p-value of treatment effects (reference to placebo) were obtained by mixed effect model analysis comparing the outcome values adjusted with repeated measures, ages and gender.|Mixed Models Analysis|||||2.58|-1.71|0.69
72565652|NCT02709486|144662692|SUPERIORITY||Odds Ratio (OR)|2.95||||0.0683|TWO_SIDED|95.0|0.92|9.47|||Regression, Logistic|||Week 4, \>=90%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||9.47|0.92|0.0683
72471484|NCT02358668|144466646|SUPERIORITY_OR_OTHER|||||||0.29||||||The univariate p-value of treatment group was obtained by t-tests comparing the changes to that of placebo group|t-test, 2 sided|||||||0.29
72471485|NCT02358668|144466646|SUPERIORITY_OR_OTHER|||||||0.22||||||The univariate p-value of treatment group was obtained by t-tests comparing the changes to that of placebo group|t-test, 2 sided|||||||0.22
72471486|NCT02358668|144466647|SUPERIORITY_OR_OTHER|||||||0.41||||||The univariate p-value of treatment group was obtained by t-tests comparing the changes to that of placebo group|t-test, 2 sided|||||||0.41
72471487|NCT02358668|144466647|SUPERIORITY_OR_OTHER|||||||0.48||||||The univariate p-value of treatment group was obtained by t-tests comparing the changes to that of placebo group|t-test, 2 sided|||||||0.48
72471488|NCT02358668|144466648|SUPERIORITY_OR_OTHER|||||||0.61||||||The univariate p-value of treatment group was obtained by t-tests comparing the changes to that of placebo group|t-test, 2 sided|||||||0.61
72565653|NCT02709486|144662692|SUPERIORITY||Odds Ratio (OR)|3.77||||0.0214|TWO_SIDED|95.0|1.22|11.66|||Regression, Logistic|||Week 4, \>=90%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||11.66|1.22|0.0214
72565654|NCT02709486|144662692|SUPERIORITY||Odds Ratio (OR)|1.83||||0.0006|TWO_SIDED|95.0|1.3|2.58|||Regression, Logistic|||Week 8, \>=30%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.58|1.30|0.0006
72395888|NCT01428453|144298185|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.0||||||95.0|-10.2|12.2|||Mixed-Model Repeated Measures analysis||Comparison of Abeta40 between placebo and rilapladib 250 mg. The analysis method for Plasma parameters was Mixed-Model Repeated Measures adjusted for Treatment, Visit, Baseline, Treatment by Visit, Baseline by Visit and Age.|||12.2|-10.2|
72395889|NCT01428453|144298186|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.003|||||TWO_SIDED|95.0|-0.016|0.01|||Mixed-Model Repeated Measures analysis||The analysis method for Plasma parameters was Mixed-Model Repeated Measures adjusted for Treatment, Visit, Baseline, Treatment by Visit, Baseline by Visit and Age.|||0.010|-0.016|
72395890|NCT01428453|144298188|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.067|||||TWO_SIDED|95.0|-0.191|0.057|||Mixed-Model Repeated Measures analysis||"The analysis method was Mixed-Model Repeated Measures adjusted for Treatment, Visit, Baseline Score, Treatment by Visit and Baseline Score by Visit. A positive treatment difference indicates benefit, relative to placebo.~placebo."|||0.057|-0.191|
72565655|NCT02709486|144662692|SUPERIORITY||Odds Ratio (OR)|1.63||||0.0048|TWO_SIDED|95.0|1.16|2.28|||Regression, Logistic|||Week 8, \>=30%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.28|1.16|0.0048
72395891|NCT01428453|144298188|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.138||||0.982|TWO_SIDED|95.0|0.01|0.267||The analysis method was Mixed-Model Repeated Measures adjusted for Treatment, Visit, Baseline Overall Composite Score, Treatment by Visit and Baseline Overall Composite Score by Visit.|Mixed-Model Repeated Measures analysis|The probability (effect size) for change from Baseline in CogState battery overall composite score \>0 is presented.|A positive treatment difference indicates benefit, relative to placebo. Comparison of overall composite score between placebo and rilapladib 250 mg at Week 24.|||0.267|0.010|0.982
72395892|NCT01428453|144298189|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.063|||||TWO_SIDED|95.0|-0.257|0.13|||Mixed-Model Repeated Measures analysis|The analysis method was Mixed-Model Repeated Measures adjusted for Treatment, Visit, Baseline Score, Treatment by Visit and Baseline Score by Visit.|Comparison of attention composite score between placebo and rilapladib 250 mg at Week 12. A positive treatment difference indicates benefit, relative to placebo.|||0.130|-0.257|
72395893|NCT01428453|144298189|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.07|||||TWO_SIDED|95.0|-0.13|0.269|||Mixed-Model Repeated Measures analysis|The analysis method was Mixed-Model Repeated Measures adjusted for Treatment, Visit, Baseline Score, Treatment by Visit and Baseline Score by Visit.|Comparison of attention composite score between placebo and rilapladib 250 mg at Week 24. A positive treatment difference indicates benefit, relative to placebo.|||0.269|-0.130|
72395894|NCT02607033|144298190|OTHER|Wilxocon signed Rank test||||||0.028|||||||Wilxocon signed Rank test|||Wilxocon signed Rank test to compare pre to post onset of pain time in the Exercise + Weight loss group. Due to low sample size were unable to compare changes between the Exercise + Weight Loss group and the Exercise only groups.||||0.028
72395895|NCT06092710|144298194|OTHER|Then, to see if the median of a particular group is diﬀerent from 0 (= no sensitivity: not feeling the diﬀerences in airflow induced by the diﬀerent tests given by the operator), Wilcoxon tests were performed on each group of data. If the p-value is small (less than 5%, ideally less than 1%), the null hypothesis that the score is identical to 0 is rejected.||||||0.05572|||||||Kruskal-Wallis|||Non-parametric tests on patient sensitivity, given the non-normal distribution, (based on the median of the data) were applied to analyse the diﬀerences between the groups (ST1+ ST2 according to the STATUS3 and STATUS4 classification criteria). To analyse any diﬀerences in sensitivity between patient groups, Kruskal-Wallis tests were applied. In this type of analysis, having a p-value greater than 1% and ideally greater than 5% would indicate the absence of diﬀerences between groups.||||0.05572
72395896|NCT06092710|144298194|OTHER|Wilcoxon tests were performed on each group of data. If the p-value is small (less than 5%, ideally less than 1%), the null hypothesis that the score is identical to 0 is rejected.|||||<|8e-07|||||||Wilcoxon (Mann-Whitney)|||to see if the median of a particular group is diﬀerent from 0 (= no sensitivity: not feeling the diﬀerences in airflow induced by the diﬀerent tests given by the operator), Wilcoxon tests were performed on each group of data. If the p-value is small (less than 5%, ideally less than 1%), the null hypothesis that the score is identical to 0 is rejected. In this case, it means that the patients in the test group feel the diﬀerences in airflow depending on their position.||||<0.0000008
72395897|NCT06092710|144298194|OTHER|Wilcoxon tests were performed on each group of data. If the p-value is small (less than 5%, ideally less than 1%), the null hypothesis that the score is identical to 0 is rejected. In this case, it means that the patients in the test group feel the diﬀerences in airflow depending on their position.|||||<|1e-07|||||||Wilcoxon (Mann-Whitney)|||to see if the median of a particular group is diﬀerent from 0 (= no sensitivity: not feeling the diﬀerences in airflow induced by the diﬀerent tests given by the operator), Wilcoxon tests were performed on each group of data. If the p-value is small (less than 5%, ideally less than 1%), the null hypothesis that the score is identical to 0 is rejected. In this case, it means that the patients in the test group feel the diﬀerences in airflow depending on their position.||||<0.0000001
72505889|NCT01592851|144543211|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.83|||<|0.0001|TWO_SIDED|95.0|-1.03|-0.63||No adjustment made for multiple comparisons, as primary comparison was pre-specified.|ANCOVA|ANCOVA with treatment as fixed factor and baseline Schiff Score as covariate.|Difference is 0.454% SnF minus 0.76% NaMFP such that a negative difference favours first named treatment.|Null hypothesis considered change from baseline to be same for both treatments.||-0.63|-1.03|<0.0001
72505890|NCT01592851|144543212|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.26||||0.0006|TWO_SIDED|95.0|-0.41|-0.12||No adjustment made for multiple comparisons, as primary comparison was pre-specified.|ANCOVA|ANCOVA with treatment as fixed factor and baseline Schiff Score as covariate.|Difference is 0.454% SnF minus 0.76% NaMFP such that a negative difference favours first named treatment.|Null hypothesis considered change from baseline to be same for both treatments.||-0.12|-0.41|0.0006
72505891|NCT01592851|144543213|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.45|||<|0.0001|TWO_SIDED|95.0|-0.63|-0.28||No adjustment made for multiple comparisons, as primary comparison was pre-specified.|ANCOVA|ANCOVA with treatment as fixed factor and baseline Schiff Score as covariate.|Difference is 0.454% SnF minus 0.76% NaMFP such that a negative difference favours first named treatment.|Null hypothesis considered change from baseline to be same for both treatments.||-0.28|-0.63|<0.0001
72505892|NCT01592851|144543214|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|19.42|||<|0.0001|TWO_SIDED|95.0|13.7|25.15||No adjustment made for multiple comparisons, as primary comparison was pre-specified.|ANCOVA|ANCOVA with treatment as fixed factor and baseline Schiff Score as covariate.|Difference is 0.454% SnF minus 0.76% NaMFP such that a positive difference favours first named treatment.|Null hypothesis considered change from baseline to be same for both treatments.||25.15|13.70|<0.0001
72505893|NCT01592851|144543215|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|6.84||||0.0021|TWO_SIDED|95.0|2.54|11.13||No adjustment made for multiple comparisons, as primary comparison was pre-specified.|ANCOVA|ANCOVA with treatment as fixed factor and baseline Schiff Score as covariate.|Difference is 0.454% SnF minus 0.76% NaMFP such that a positive difference favours first named treatment.|Null hypothesis considered change from baseline to be same for both treatments.||11.13|2.54|0.0021
72565656|NCT02709486|144662692|SUPERIORITY||Odds Ratio (OR)|1.84||||0.0012|TWO_SIDED|95.0|1.27|2.65|||Regression, Logistic|||Week 8, \>=50%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.65|1.27|0.0012
72622889|NCT02796651|144775944|SUPERIORITY||LSMean difference|0.167|||<|0.001|TWO_SIDED|95.0|0.128|0.206|||Mixed Models Analysis|||||0.206|0.128|<0.001
72622890|NCT02796651|144775944|SUPERIORITY||LSMean difference|0.224|||<|0.001|TWO_SIDED|95.0|0.184|0.263|||Mixed Models Analysis|||||0.263|0.184|<0.001
72395898|NCT06092710|144298195|SUPERIORITY|||||||1.06e-06||||||Confidence level used: 0.95 Tukey multiple comparisons of means (95% family-wise confidence level)|ANOVA|||Parametric tests on the prediction of patients' pathological status with SFI (Intermediate Final Score) For these analyses, as the SFI score follow a normal distribution, ANOVAs (analyses of variance) were performed. For discrete variables with more than 2 levels of value, a post-hoc 2-to-2 comparison analysis was performed (Tukey) to see which level of the variable diﬀered from one another.||||0.00000106
72395899|NCT06092710|144298195|SUPERIORITY|||||||48||||||Confidence level used: 0.95 Tukey multiple comparisons of means (95% family-wise confidence level)|ANOVA|||"Parametric tests on the prediction of patients' pathological status with SFT score (Final Total score):~For these analyses, as SFT score follow a normal distribution, ANOVAs (analyses of variance) were performed. For discrete variables with more than 2 levels of value, a post-hoc 2-to-2 comparison analysis was performed (Tukey) to see which level of the variable diﬀered from one another."||||0000000048
72395900|NCT06092710|144298195|SUPERIORITY||Odds Ratio (OR)|8.73||||7.7e-07|TWO_SIDED||||||Fisher Exact|||"Determination of cut-oﬀ values for SFI:~The Cutoﬀ\_final txt file includes the various sensitivity and specificity calculations as well as the Youden index in order to determine the best cut-oﬀ value (largest Youden). The ROC curves allow the values in the file to be appreciated graphically."||||0.00000077
72395901|NCT06092710|144298195|SUPERIORITY||Odds Ratio (OR)|9.37||||6.9e-07|TWO_SIDED||||||Fisher Exact|||"Determination of cut-oﬀ values for SFT:~The Cutoﬀ\_final txt file includes the various sensitivity and specificity calculations as well as the Youden index in order to determine the best cut-oﬀ value (largest Youden). The ROC curves allow the values in the file to be appreciated graphically."||||0.00000069
72395902|NCT06092710|144298196|SUPERIORITY|||||||0.0142266|||||||TUKEY TEST|||"Parametric tests on the prediction of patients' pathological status (SFI and SFT scores):~For these analyses, as the SFI and SFT scores follow a normal distribution, ANOVAs (analyses of variance) were performed. For discrete variables with more than 2 levels of value (STATUS4), a post-hoc 2-to-2 comparison analysis was performed (Tukey) to see which level of the variable diﬀered from one another."||||0.0142266
72395903|NCT06092710|144298196|SUPERIORITY|||||||0.0023308|||||||TUKEY TEST|||"Parametric tests on the prediction of patients' pathological status (SFI and SFT scores):~For these analyses, as the SFI and SFT scores follow a normal distribution, ANOVAs (analyses of variance) were performed. For discrete variables with more than 2 levels of value (STATUS4), a post-hoc 2-to-2 comparison analysis was performed (Tukey) to see which level of the variable diﬀered from one another."||||0.0023308
72395904|NCT06092710|144298196|SUPERIORITY|||||||0.0023308|||||||TUKEY TEST|||"Parametric tests on the prediction of patients' pathological status (SFI and SFT scores):~For these analyses, as the SFI and SFT scores follow a normal distribution, ANOVAs (analyses of variance) were performed. For discrete variables with more than 2 levels of value (STATUS4), a post-hoc 2-to-2 comparison analysis was performed (Tukey) to see which level of the variable diﬀered from one another."||||0.0023308
72395905|NCT06092710|144298196|SUPERIORITY|||||||0.9915779|||||||TUKEY TEST|||"Parametric tests on the prediction of patients' pathological status (SFI and SFT scores):~For these analyses, as the SFI and SFT scores follow a normal distribution, ANOVAs (analyses of variance) were performed. For discrete variables with more than 2 levels of value (STATUS4), a post-hoc 2-to-2 comparison analysis was performed (Tukey) to see which level of the variable diﬀered from one another."||||0.9915779
72395906|NCT06092710|144298196|SUPERIORITY|||||||0.9999943|||||||TUKEY TEST|||"Parametric tests on the prediction of patients' pathological status (SFI and SFT scores):~For these analyses, as the SFI and SFT scores follow a normal distribution, ANOVAs (analyses of variance) were performed. For discrete variables with more than 2 levels of value (STATUS4), a post-hoc 2-to-2 comparison analysis was performed (Tukey) to see which level of the variable diﬀered from one another."||||0.9999943
72471489|NCT02358668|144466648|SUPERIORITY_OR_OTHER|||||||0.89||||||The univariate p-value of treatment group was obtained by t-tests comparing the changes to that of placebo group|t-test, 2 sided|||||||0.89
72471490|NCT04057573|144466649|SUPERIORITY||Odds Ratio (OR)|3.45||||0.0004|TWO_SIDED|95.0|1.737|6.835||The model included the treatment group (1.5% BID and vehicle) and stratification factors (skin type and region).|exact logistic regression|||||6.835|1.737|0.0004
72471491|NCT04057573|144466650|SUPERIORITY||Odds Ratio (OR)|3.99|||<|0.0001|TWO_SIDED|95.0|2.296|6.949||The model included the treatment group (1.5% BID and vehicle) and stratification factors (skin type and region).|exact logistic regression|||||6.949|2.296|< 0.0001
72505894|NCT01592851|144543216|SUPERIORITY_OR_OTHER||Adjusted Mean DIfference|3.87||||0.007|TWO_SIDED|95.0|1.08|6.65||No adjustment made for multiple comparisons, as primary comparison was pre-specified.|ANCOVA|ANCOVA with treatment as fixed factor and baseline Schiff Score as covariate.|Difference is 0.454% SnF minus 0.76% NaMFP such that a positive difference favours first named treatment.|Null hypothesis considered change from baseline to be same for both treatments.||6.65|1.08|0.0070
72505895|NCT01591018|144543229|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05||||||Pre-study calculations using chi-square test with a continuity correction showed that ≥60 patients in each group were needed to reach a significant difference with an alpha value of 0.05 (two-tailed) and a beta value of 0.8.|Chi-squared, Corrected|||Sample size was based on an expected 20% reduction of new ischemic lesions on DW-MRI in the sonolysis group (estimated prevalence, 10%) compared with the control group (estimated prevalence, 30%).||||<0.05
72471492|NCT04057573|144466651|SUPERIORITY||Odds Ratio (OR)|15.29||||0.0065|TWO_SIDED|95.0|2.15|108.739||The model included the treatment group (1.5% BID and vehicle) and stratification factors (skin type and region).|exact logistic regression|||||108.739|2.150|0.0065
72471493|NCT04057573|144466652|SUPERIORITY||Odds Ratio (OR)|4.29||||0.0006|TWO_SIDED|95.0|1.865|9.853||The model included the treatment group (1.5% BID and vehicle) and stratification factors (skin type and region).|exact logistic regression|||||9.853|1.865|0.0006
72505896|NCT04498910|144543269|SUPERIORITY||Difference in Estimated change|-1.1|STANDARD_ERROR_OF_MEAN|1.2|||TWO_SIDED|95.0|-3.6|1.2|||Bayesian Mixed Model Analysis|||||1.2|-3.6|
72471494|NCT04057573|144466653|SUPERIORITY||Odds Ratio (OR)|4.86||||0.0013|TWO_SIDED|95.0|1.851|12.755||The model included the treatment group (1.5% BID and vehicle) and stratification factors (skin type and region).|exact logistic regression|||||12.755|1.851|0.0013
72471495|NCT04057573|144466654|SUPERIORITY||Least squares mean difference|-19.5|STANDARD_ERROR_OF_MEAN|4.59|<|0.0001|TWO_SIDED|95.0|-28.46|-10.45||Response Variable = Treatment + Stratification Factors (Skin Type Fitzpatrick scale Type I, II versus Type III, IV, V, and VI, Region North America/Europe) + Baseline|ANCOVA|||||-10.45|-28.46|< 0.0001
72395907|NCT06092710|144298196|SUPERIORITY|||||||0.9905111|||||||TUKEY TEST|||"Parametric tests on the prediction of patients' pathological status (SFI and SFT scores):~For these analyses, as the SFI and SFT scores follow a normal distribution, ANOVAs (analyses of variance) were performed. For discrete variables with more than 2 levels of value (STATUS4), a post-hoc 2-to-2 comparison analysis was performed (Tukey) to see which level of the variable diﬀered from one another."||||0.9905111
72395908|NCT03789318|144298197|SUPERIORITY|||||||0.2912|||||||ANOVA|||||||0.2912
72505897|NCT04498910|144543270|SUPERIORITY||Difference in Estimated change|-1.5|STANDARD_ERROR_OF_MEAN|1.3|||TWO_SIDED|95.0|-4.2|1.0|||Bayesian Mixed Model Analysis|||||1.0|-4.2|
72505898|NCT00909090|144543287|SUPERIORITY|||||||0.01|||||||t-test, 2 sided|||||||0.01
72505899|NCT00909090|144543288|SUPERIORITY|||||||0.21|||||||Regression, Linear|||Analysis compared mean differences between placebo and intervention at the 12-month time point.||||0.21
72505900|NCT00909090|144543289|SUPERIORITY|||||||0.01|||||||t-test, 1 sided|||Analysis compared mean change from baseline to 12-month time points.||||0.01
72505901|NCT00909090|144543290|SUPERIORITY|||||||0.02|||||||t-test, 2 sided|||analysis conducted on mean change over one year, between groups||||0.02
72505902|NCT02926573|144543293|SUPERIORITY||Median Difference (Final Values)|0.26|||||TWO_SIDED|95.0|-0.27|0.94||||||||0.94|-0.27|
72505903|NCT02926573|144543294|SUPERIORITY||Percent Difference|9.2|||||TWO_SIDED|95.0|-3.0|21.0||||||||21|-3.0|
72505904|NCT02926573|144543296|SUPERIORITY||Percent Difference|-2.0|||||TWO_SIDED|95.0|-15.0|11.0|||||"The estimation parameter is based on those participants who answered they were very satisfied with overall pain control."|||11|-15|
72395909|NCT03789318|144298198|SUPERIORITY|||||||0.498|||||||ANOVA|||||||0.4980
72505905|NCT02926573|144543297|SUPERIORITY||Mean Difference (Final Values)|7.4|||||TWO_SIDED|95.0|-3.4|18.3|||||This statistical analysis is for the mean difference between the 2 arms at Post-Operative Day 1 7AM.|||18.3|-3.4|
72505906|NCT02926573|144543297|SUPERIORITY||Mean Difference (Final Values)|8.7|||||TWO_SIDED|95.0|-2.9|20.3|||||This statistical analysis is for the mean difference between the 2 arms at Post-Operative Day 1 10AM.|||20.3|-2.9|
72505907|NCT02926573|144543297|SUPERIORITY||Mean Difference (Final Values)|7.2|||||TWO_SIDED|95.0|-4.6|18.9|||||This statistical analysis is for the mean difference between the 2 arms at Post-Operative Day 1 7PM.|||18.9|-4.6|
72505908|NCT02926573|144543297|SUPERIORITY||Mean Difference (Final Values)|5.1|||||TWO_SIDED|95.0|-6.6|16.8|||||This statistical analysis is for the mean difference between the 2 arms at Post-Operative Day 2 7AM.|||16.8|-6.6|
72505909|NCT02926573|144543297|SUPERIORITY||Mean Difference (Final Values)|7.4|||||TWO_SIDED|95.0|-3.6|18.3|||||This statistical analysis is for the mean difference between the 2 arms at Post-Operative Day 2 10AM.|||18.3|-3.6|
72505910|NCT02926573|144543297|SUPERIORITY||Mean Difference (Final Values)|8.0|||||TWO_SIDED|95.0|-5.6|21.6|||||This statistical analysis is for the mean difference between the 2 arms at Post-Operative Day 2 7PM.|||21.6|-5.6|
72505911|NCT02926573|144543297|SUPERIORITY||Mean Difference (Final Values)|10.1|||||TWO_SIDED|95.0|-3.5|23.8|||||This statistical analysis is for the mean difference between the 2 arms at Post-Operative Day 3 7AM.|||23.8|-3.5|
72505912|NCT02926573|144543298|SUPERIORITY||Mean Difference (Final Values)|10.7|||||TWO_SIDED|95.0|-0.9|22.3|||||This statistical analysis is for the mean difference between the 2 arms at Post-Operative Day 1 7AM.|||22.3|-0.9|
72505913|NCT02926573|144543298|SUPERIORITY||Mean Difference (Final Values)|9.1|||||TWO_SIDED|95.0|-3.4|21.6|||||This statistical analysis is for the mean difference between the 2 arms at Post-Operative Day 1 10AM.|||21.6|-3.4|
72505914|NCT02926573|144543298|SUPERIORITY||Mean Difference (Final Values)|6.3|||||TWO_SIDED|95.0|-6.1|18.6|||||This statistical analysis is for the mean difference between the 2 arms at Post-Operative Day 1 7PM.|||18.6|-6.1|
72505915|NCT02926573|144543298|SUPERIORITY||Mean Difference (Final Values)|5.3|||||TWO_SIDED|95.0|-7.3|17.8|||||This statistical analysis is for the mean difference between the 2 arms at Post-Operative Day 2 7AM.|||17.8|-7.3|
72395910|NCT03789318|144298199|SUPERIORITY|||||||0.1958|||||||Log Rank|||||||0.1958
72395911|NCT03789318|144298200|SUPERIORITY|||||||0.9546|||||||Regression, Logistic|||||||0.9546
72395912|NCT03789318|144298201|SUPERIORITY|||||||0.4434|||||||ANOVA|||||||0.4434
72395913|NCT01317160|144298202|SUPERIORITY_OR_OTHER_LEGACY|||||||0.042|TWO_SIDED||||||Chi-squared|||Domeij-Arverud et al., Bone Joint J 2015;97-B:675-80.||||0.042
72395914|NCT01317160|144298202|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.81|||<|0.05|TWO_SIDED|95.0|1.25|6.32|||Regression, Logistic|Age was adjusted for in the calculation.|Risk of VTE by routine care (numerator) divided by IPC treatment (denominator)|||6.32|1.25|<0.05
72395915|NCT01317160|144298204|SUPERIORITY_OR_OTHER_LEGACY|||||||0.737|TWO_SIDED||||||Chi-squared|||||||0.737
72395916|NCT04203238|144298215|SUPERIORITY||Median Difference (Final Values)|0.89|||<|0.05|TWO_SIDED||||||Mixed Models Analysis|||||||<0.05
72505916|NCT02926573|144543298|SUPERIORITY||Mean Difference (Final Values)|11.2|||||TWO_SIDED|95.0|-1.4|23.8|||||This statistical analysis is for the mean difference between the 2 arms at Post-Operative Day 2 10AM.|||23.8|-1.4|
72505917|NCT02926573|144543298|SUPERIORITY||Mean Difference (Final Values)|14.9|||||TWO_SIDED|95.0|-0.1|29.9|||||This statistical analysis is for the mean difference between the 2 arms at Post-Operative Day 2 7PM.|||29.9|-0.1|
72505918|NCT02926573|144543298|SUPERIORITY||Mean Difference (Final Values)|11.6|||||TWO_SIDED|95.0|-2.8|26.0|||||This statistical analysis is for the mean difference between the 2 arms at Post-Operative Day 3 7AM.|||26.0|-2.8|
72505919|NCT02926573|144543299|SUPERIORITY||Mean Difference (Final Values)|-1.4|||||TWO_SIDED|95.0|-14.7|11.9|||||This statistical analysis is for the mean difference between the 2 arms at Post-Operative Day 1 7AM.|||11.9|-14.7|
72505920|NCT02926573|144543299|SUPERIORITY||Mean Difference (Final Values)|5.3|||||TWO_SIDED|95.0|-8.6|19.2|||||This statistical analysis is for the mean difference between the 2 arms at Post-Operative Day 1 10AM.|||19.2|-8.6|
72505921|NCT02926573|144543299|SUPERIORITY||Mean Difference (Final Values)|10.9|||||TWO_SIDED|95.0|-2.4|24.2|||||This statistical analysis is for the mean difference between the 2 arms at Post-Operative Day 1 7PM.|||24.2|-2.4|
72505922|NCT02926573|144543299|SUPERIORITY||Mean Difference (Final Values)|7.0|||||TWO_SIDED|95.0|-6.6|20.7|||||||This statistical analysis is for the mean difference between the 2 arms at Post-Operative Day 2 7AM.|20.7|-6.6|
72505923|NCT02926573|144543299|SUPERIORITY||Mean Difference (Final Values)|8.0|||||TWO_SIDED|95.0|-6.4|22.3|||||This statistical analysis is for the mean difference between the 2 arms at Post-Operative Day 2 10AM.|||22.3|-6.4|
72395917|NCT02771990|144298279|OTHER|Pilot study|z-score|3.11||||0.002|TWO_SIDED||||||Regression, Linear|||||||0.002
72565657|NCT02709486|144662692|SUPERIORITY||Odds Ratio (OR)|2.41|||<|0.0001|TWO_SIDED|95.0|1.68|3.47|||Regression, Logistic|||Week 8, \>=50%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.47|1.68|<.0001
72565658|NCT02709486|144662692|SUPERIORITY||Odds Ratio (OR)|1.65||||0.0537|TWO_SIDED|95.0|0.99|2.74|||Regression, Logistic|||Week 8, \>=70%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.74|0.99|0.0537
72565659|NCT02709486|144662692|SUPERIORITY||Odds Ratio (OR)|2.55||||0.0001|TWO_SIDED|95.0|1.58|4.13|||Regression, Logistic|||Week 8, \>=70%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||4.13|1.58|0.0001
72565660|NCT02709486|144662692|SUPERIORITY||Odds Ratio (OR)|2.26||||0.1155|TWO_SIDED|95.0|0.82|6.27|||Regression, Logistic|||Week 8, \>=90%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||6.27|0.82|0.1155
72565661|NCT02709486|144662692|SUPERIORITY||Odds Ratio (OR)|3.0||||0.0271|TWO_SIDED|95.0|1.13|7.96|||Regression, Logistic|||Week 8, \>=90%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||7.96|1.13|0.0271
72565662|NCT02709486|144662692|SUPERIORITY||Odds Ratio (OR)|1.85||||0.0007|TWO_SIDED|95.0|1.3|2.63|||Regression, Logistic|||Week 12, \>=30%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.63|1.30|0.0007
72565663|NCT02709486|144662692|SUPERIORITY||Odds Ratio (OR)|1.8||||0.0011|TWO_SIDED|95.0|1.26|2.56|||Regression, Logistic|||Week 12, \>=30%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.56|1.26|0.0011
72565664|NCT02709486|144662692|SUPERIORITY||Odds Ratio (OR)|1.79||||0.0009|TWO_SIDED|95.0|1.27|2.52|||Regression, Logistic|||Week 12, \>=50%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.52|1.27|0.0009
72565665|NCT02709486|144662692|SUPERIORITY||Odds Ratio (OR)|2.07|||<|0.0001|TWO_SIDED|95.0|1.47|2.91|||Regression, Logistic|||Week 12, \>=50%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.91|1.47|<.0001
72565666|NCT02709486|144662692|SUPERIORITY||Odds Ratio (OR)|1.81||||0.0064|TWO_SIDED|95.0|1.18|2.78|||Regression, Logistic|||Week 12, \>=70%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.78|1.18|0.0064
72565667|NCT02709486|144662692|SUPERIORITY||Odds Ratio (OR)|1.68||||0.018|TWO_SIDED|95.0|1.09|2.58|||Regression, Logistic|||Week 12, \>=70%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.58|1.09|0.0180
72565668|NCT02709486|144662692|SUPERIORITY||Odds Ratio (OR)|5.61||||0.0006|TWO_SIDED|95.0|2.09|15.08|||Regression, Logistic|||Week 12, \>=90%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||15.08|2.09|0.0006
72565669|NCT02709486|144662692|SUPERIORITY||Odds Ratio (OR)|4.46||||0.0034|TWO_SIDED|95.0|1.64|12.13|||Regression, Logistic|||Week 12, \>=90%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||12.13|1.64|0.0034
72565670|NCT02709486|144662692|SUPERIORITY||Odds Ratio (OR)|1.72||||0.0022|TWO_SIDED|95.0|1.22|2.44|||Regression, Logistic|||Week 16, \>=30%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.44|1.22|0.0022
72565671|NCT02709486|144662692|SUPERIORITY||Odds Ratio (OR)|1.77||||0.0014|TWO_SIDED|95.0|1.25|2.5|||Regression, Logistic|||Week 16, \>=30%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.50|1.25|0.0014
72622891|NCT02796651|144775944|SUPERIORITY||LSMean difference|0.214|||<|0.001|TWO_SIDED|95.0|0.176|0.253|||Mixed Models Analysis|||||0.253|0.176|<0.001
72395918|NCT02771990|144298280|OTHER|Pilot study||||||0.67|||||||Regression, Linear|||||||0.67
72471496|NCT04057573|144466657|SUPERIORITY||Odds Ratio (OR)|3.76|||<|0.0001|TWO_SIDED|95.0|2.267|6.246||The model included the treatment group (1.5% BID and vehicle) and stratification factors (skin type and region).|exact logistic regression|||||6.246|2.267|< 0.0001
72395919|NCT00848081|144298281|SUPERIORITY_OR_OTHER|||||||0.403||||||1-sided test|Fisher Exact|||The p-value is from a one-sided Fisher's exact test with a significance level of 0.05. A total of 142 subjects per treatment arm would provide 91% power to detect the difference between a Group 1 proportion of 0.03 and a Group 2 proportion of 0.13.||||0.403
72395920|NCT00848081|144298283|SUPERIORITY_OR_OTHER|||||||0.13||||||p-value is on change from baseline|ANCOVA|||The LS mean, standard error, 2-sided 95% confidence interval and p-value for the difference between placebo and tadalafil 5 mg are from an analysis of covariance (ANCOVA) model.||||0.130
72395921|NCT00848081|144298284|SUPERIORITY_OR_OTHER|||||||0.258||||||p-value is on change from baseline|ANOVA|The p-value is from Type III sums of squares ANOVA on rank-transformed data.||||||0.258
72395922|NCT00848081|144298285|SUPERIORITY_OR_OTHER|||||||0.828|||||||ANOVA|P-value is from Type III sums of squares ANOVA on rank-transformed data; p-value is on change from baseline.||||||0.828
72395923|NCT02064868|144298286|SUPERIORITY||Hazard Ratio (HR)|0.71||||0.0172|TWO_SIDED|95.0|0.51|0.98||One-sided p-value|Gehan's generalized Wilcoxon test|||||0.98|0.51|0.0172
72395924|NCT02064868|144298287|SUPERIORITY||Hazard Ratio (HR)|0.79||||0.0634|TWO_SIDED|95.0|0.61|1.02||Two-sided p-value|Gehan's generalized Wilcoxon test|||||1.02|0.61|0.0634
72395925|NCT02064868|144298288|SUPERIORITY||||||<|0.0001|||||||Chi-squared|||||||<0.0001
72395926|NCT02064868|144298289|SUPERIORITY|||||||0.0002|||||||Chi-squared|||||||0.0002
72395927|NCT02064868|144298290|SUPERIORITY|||||||0.1392|||||||Wilcoxon (Mann-Whitney)|||||||0.1392
72395928|NCT02064868|144298292|SUPERIORITY|||||||0.3115|||||||Mixed Models Analysis|||Day 5||||0.3115
72395929|NCT02064868|144298292|SUPERIORITY|||||||0.1236|||||||Mixed Models Analysis|||Day 14||||0.1236
72395930|NCT02014597|144298294|OTHER|||||||0.0583||||||Scotopic logCS|Kruskal-Wallis|||||||0.0583
72395931|NCT02014597|144298294|OTHER|||||||0.1762||||||Photopic logCS|Kruskal-Wallis|||||||0.1762
72395932|NCT02014597|144298295|OTHER|||||||0.183||||||Scotopic|Pearson correlation|||Correlation between logCS and MD.||||0.183
72395933|NCT02014597|144298295|OTHER|||||||0.771||||||Photopic|Pearson correlation|||Correlation between logCS and MD.||||0.771
72395934|NCT02014597|144298295|OTHER|||||||0.492||||||Scotopic|Pearson correlation|||Correlation between logCS and PSD.||||0.492
72395935|NCT02014597|144298295|OTHER|||||||0.83||||||Photopic|Pearson correlation|||Correlation between logCS and PSD.||||0.830
72395936|NCT00711711|144298298|SUPERIORITY_OR_OTHER|||||||0.51|||||||Wilcoxon (Mann-Whitney)|||All outcomes and control variables were compared between the treatment and the control group at each time point using the Wilcoxon rank-sum test or the chi-square test, as appropriate. The change in swelling from second day to seventh day, that is, during the treatment period, was compared using the Wilcoxon signed-rank test. The significance level was set at P\<.05.||||0.51
72395937|NCT00711711|144298299|SUPERIORITY_OR_OTHER|||||||0.58|||||||Wilcoxon (Mann-Whitney)|||All outcomes and control variables were compared between the treatment and the control group at each time point using the Wilcoxon rank-sum test or the chi-square test, as appropriate. The change in swelling from second day to seventh day, that is, during the treatment period, was compared using the Wilcoxon signed-rank test. The significance level was set at P\<.05.||||0.58
72395938|NCT00754624|144298319|SUPERIORITY_OR_OTHER||Slope|-0.048|||||TWO_SIDED|95.0|-0.059|-0.037|||Random coefficient|Adjusted for Baseline FEV1 value||A random coefficient model with a random intercept and slope associated with each subject, was fitted (using the PROC MIXED procedure in SAS) to the observed FEV1 data to estimate the annual rate of decline. The model included terms for baseline FEV1 and time (in years) of FEV1 measurements. Missing pulmonary functions were not imputed.||-0.037|-0.059|
72395939|NCT00754624|144298320|SUPERIORITY_OR_OTHER||Slope|-0.058|||||TWO_SIDED|95.0|-0.072|-0.043|||Random Coefficient|Adjusted for Baseline FVC value||A random coefficient model with a random intercept and slope associated with each subject, was fitted (using the PROC MIXED procedure in SAS) to the observed FVC data to estimate the annual rate of decline. The model included terms for baseline FVC and time (in years) of FVC measurements. Missing pulmonary functions were not imputed.||-0.043|-0.072|
72395940|NCT00754624|144298321|SUPERIORITY_OR_OTHER||Slope|-0.311|||||TWO_SIDED|95.0|-0.454|-0.168|||Random Coefficient|Adjusted for Baseline DLCo value||A random coefficient model with a random intercept and slope associated with each subject, was fitted (using the PROC MIXED procedure in SAS) to the observed DLco data to estimate the annual rate of decline. The model included terms for baseline DLco and time (in years) of DLco measurements. Missing pulmonary functions were not imputed.||-0.168|-0.454|
72395941|NCT02664441|144298339|SUPERIORITY||Mean Difference (Net)|-1.7||||0.4|TWO_SIDED|95.0|-4.1|0.6|||Mixed Models Analysis|Randomization stratification variables (site, sex and age group) were used as covariates.||||0.6|-4.1|0.40
72395942|NCT02664441|144298340|SUPERIORITY||Mean Difference (Net)|-3.1||||0.02|TWO_SIDED|95.0|-5.7|-0.4|||Mixed Models Analysis|Randomization stratification variables (site, sex and age group) were used as covariates.||||-0.4|-5.7|0.02
72395943|NCT02664441|144298341|SUPERIORITY||Mean Difference (Final Values)|-20.2||||0.032|TWO_SIDED|95.0|-37.8|-2.7|||Regression, Linear|Adjusted for baseline values||Analysis for Fat Intake||-2.7|-37.8|.032
72395944|NCT02664441|144298341|SUPERIORITY||Mean Difference (Net)|-430.0||||0.02|TWO_SIDED|95.0|-761.0|-100.0|||Regression, Linear|Adjusted for baseline values||Analysis for Total Calorie Intake||-100|-761|.02
72395945|NCT02664441|144298342|SUPERIORITY||Geometric Mean Ratio|1.42||||0.19|TWO_SIDED|95.0|0.97|2.08|||Mixed Models Analysis|Randomization stratification variables (site, sex and age group) as covariates.|Data were log-transformed prior to analysis. Results were back-transformed through exponentiation and presented as geometric mean ratios with 95% confidence intervals|||2.08|0.97|0.19
72395946|NCT02664441|144298343|SUPERIORITY||Geometric Mean Ratio|1.0||||0.82|TWO_SIDED|95.0|0.91|1.11|||Mixed Models Analysis|Randomization stratification variables (site, sex and age group) as covariates.|Data were log-transformed prior to analysis. Results were back-transformed through exponentiation and presented as geometric mean ratios with 95% confidence intervals|Analysis for HDL Cholesterol||1.11|0.91|0.82
72395947|NCT02664441|144298343|SUPERIORITY||Geometric Mean Ratio|1.0||||0.92|TWO_SIDED|95.0|0.83|1.19|||Mixed Models Analysis|Randomization stratification variables (site, sex and age group) as covariates.|Data were log-transformed prior to analysis. Results were back-transformed through exponentiation and presented as geometric mean ratios with 95% confidence intervals|Analysis for Triglycerides||1.19|0.83|0.92
72395948|NCT02664441|144298344|SUPERIORITY||Geometric Mean Ratio|0.62||||0.03|TWO_SIDED|95.0|0.41|0.92|||Mixed Models Analysis|Randomization stratification variables (site, sex and age group) as covariates|Data were log-transformed prior to analysis. Results were back-transformed through exponentiation and presented as geometric mean ratios with 95% confidence intervals|||0.92|0.41|0.03
72471497|NCT04057573|144466659|SUPERIORITY||Least squares mean difference|-28.59|STANDARD_ERROR_OF_MEAN|4.94|<|0.0001|TWO_SIDED|95.0|-38.33|-18.86|||mixed-effect model; repeated measurement|||||-18.86|-38.33|<0.0001
72471498|NCT04057573|144466662|SUPERIORITY||least squares mean difference|-19.85|STANDARD_ERROR_OF_MEAN|3.4|<|0.0001|TWO_SIDED|95.0|-26.55|-13.16|||mixed-effect model; repeated measurement|||||-13.16|-26.55|<0.0001
72395949|NCT02664441|144298345|SUPERIORITY||Geometric Mean Ratio|1.39||||0.32|TWO_SIDED|95.0|0.9|2.14|||Mixed Models Analysis|Randomization stratification variables (site, sex and age group) as covariates|Data were log-transformed prior to analysis. Results were back-transformed through exponentiation and presented as geometric mean ratios with 95% confidence intervals|||2.14|0.90|0.32
72395950|NCT02664441|144298346|SUPERIORITY||Geometric Mean Ratio|0.95||||0.69|TWO_SIDED|95.0|0.81|1.1|||Mixed Models Analysis|Randomization stratification variables (site, sex and age group) were used as covariates.|Data were log-transformed prior to analysis. Results were back-transformed through exponentiation and presented as geometric mean ratios with 95% confidence intervals.|||1.10|0.81|0.69
72395951|NCT02664441|144298347|SUPERIORITY||Mean Difference (Net)|-166.4||||0.004|TWO_SIDED|95.0|-269.7|-63.1|||Regression, Linear|Adjusted for baseline values||||-63.1|-269.7|0.004
72395952|NCT02664441|144298348|SUPERIORITY||Mean Difference (Net)|-145.0||||0.58|TWO_SIDED|95.0|-653.5|363.4|||Regression, Linear|Adjusted for baseline||||363.4|-653.5|0.58
72395953|NCT02664441|144298349|SUPERIORITY||Mean Difference (Net)|-8.5||||0.088|TWO_SIDED|95.0|-19.1|2.1|||Mixed Models Analysis|Randomization stratification variables (site, sex and age group) were used as covariates.||||2.1|-19.1|0.088
72395954|NCT01529346|144298352|SUPERIORITY_OR_OTHER||Least Squares (LS) Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.18|||TWO_SIDED|90.0|-0.38|0.22||||||15 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.22|-0.38|
72395955|NCT01529346|144298352|SUPERIORITY_OR_OTHER||LS Mean Difference|0.09|STANDARD_ERROR_OF_MEAN|0.18|||TWO_SIDED|90.0|-0.2|0.39||||||15 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.39|-0.20|
72395956|NCT01529346|144298352|SUPERIORITY_OR_OTHER||LS Mean Difference|0.02|STANDARD_ERROR_OF_MEAN|0.18|||TWO_SIDED|90.0|-0.28|0.32||||||15 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.32|-0.28|
72395957|NCT01529346|144298352|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.2|||TWO_SIDED|90.0|-0.41|0.24||||||15 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.24|-0.41|
72471499|NCT04057573|144466664|SUPERIORITY||least squares mean difference|-11.95|STANDARD_ERROR_OF_MEAN|2.68|<|0.0001|TWO_SIDED|95.0|-17.23|-6.67|||mixed-effect model; repeated measurement|||||-6.67|-17.23|<0.0001
72471500|NCT04057573|144466666|SUPERIORITY||Odds Ratio (OR)|3.75|||<|0.0001|TWO_SIDED|95.0|2.121|6.63||The model included the treatment group (1.5% BID and vehicle) and stratification factors (skin type and region).|exact logistic regression|||T-VASI25||6.630|2.121|< 0.0001
72471501|NCT04057573|144466666|SUPERIORITY||Odds Ratio (OR)|4.59||||0.0436|TWO_SIDED|95.0|1.045|20.192||The model included the treatment group (1.5% BID and vehicle) and stratification factors (skin type and region).|exact logistic regression|||T-VASI75||20.192|1.045|0.0436
72471502|NCT04057573|144466666|SUPERIORITY||Odds Ratio (OR)|1.35||||||||||The p value was not evaluable because the response rate in the vehicle group was too low.||||T-VASI90||||
72471503|NCT04057573|144466669|SUPERIORITY||least squares mean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.51||0.235|TWO_SIDED|95.0|-1.6|0.39|||mixed-effect model; repeated measurement|||||0.39|-1.60|0.2350
72471504|NCT01381575|144466682|NON_INFERIORITY|Non-inferiority with respect to seroconversion was demonstrated if, 1 month after the last dose, for both anti-HPV-16 and anti-HPV-18, the upper limit of the 95% Confidence Interval (CI) for the difference (Cervarix 2 Group minus Cervarix 1 Group) was below 5%.|Difference in SCR|0.0|||||TWO_SIDED|95.0|-1.08|0.78||||||Immune response to anti-HPV-16 in terms of seroconversion (SCR) rates: To evaluate sequentially if the immunogenicity (as determined by ELISA) of Cervarix vaccine administered according to a 2-dose schedule of 0,6 months in 9-14 year old females was non-inferior to that administered according to the standard 3-dose schedule of 0,1,6 months in 15-25 year old females, 1 month after the last dose of study vaccine, in initially seronegative subjects.||0.78|-1.08|
72505924|NCT02926573|144543299|SUPERIORITY||Mean Difference (Final Values)|15.7|||||TWO_SIDED|95.0|-0.4|31.7|||||This statistical analysis is for the mean difference between the 2 arms at Post-Operative Day 2 7PM.|||31.7|-0.4|
72505925|NCT02926573|144543299|SUPERIORITY||Mean Difference (Final Values)|16.7|||||TWO_SIDED|95.0|0.0|33.4|||||This statistical analysis is for the mean difference between the 2 arms at Post-Operative Day 3 7AM.|||33.4|0.0|
72395958|NCT01529346|144298352|SUPERIORITY_OR_OTHER||LS Mean Difference|0.06|STANDARD_ERROR_OF_MEAN|0.23|||TWO_SIDED|90.0|-0.32|0.44||||||30 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.44|-0.32|
72395959|NCT01529346|144298352|SUPERIORITY_OR_OTHER||LS Mean Difference|0.39|STANDARD_ERROR_OF_MEAN|0.23|||TWO_SIDED|90.0|0.01|0.77||||||30 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.77|0.01|
72395960|NCT01529346|144298352|SUPERIORITY_OR_OTHER||LS Mean Difference|0.16|STANDARD_ERROR_OF_MEAN|0.23|||TWO_SIDED|90.0|-0.22|0.54||||||30 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.54|-0.22|
72395961|NCT01529346|144298352|SUPERIORITY_OR_OTHER||LS Mean Difference|0.66|STANDARD_ERROR_OF_MEAN|0.25|||TWO_SIDED|90.0|0.24|1.07||||||30 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||1.07|0.24|
72395962|NCT01529346|144298352|SUPERIORITY_OR_OTHER||LS Mean Difference|0.02|STANDARD_ERROR_OF_MEAN|0.24|||TWO_SIDED|90.0|-0.37|0.42||||||45 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.42|-0.37|
72395963|NCT01529346|144298352|SUPERIORITY_OR_OTHER||LS Mean Difference|0.39|STANDARD_ERROR_OF_MEAN|0.24|||TWO_SIDED|90.0|0.0|0.78||||||45 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.78|-0.00|
72395964|NCT01529346|144298352|SUPERIORITY_OR_OTHER||LS Mean Difference|0.11|STANDARD_ERROR_OF_MEAN|0.24|||TWO_SIDED|90.0|-0.29|0.5||||||45 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.50|-0.29|
72471505|NCT01381575|144466682|NON_INFERIORITY|Non-inferiority with respect to seroconversion was demonstrated if, 1 month after the last dose, for both anti-HPV-16 and anti-HPV-18, the upper limit of the 95% Confidence Interval (CI) for the difference (Cervarix 2 Group minus Cervarix 1 Group) was below 5%.|Difference in SCR|0.0|||||TWO_SIDED|95.0|-1.0|0.77||||||Immune response to anti-HPV-18 in terms of seroconversion (SCR) rates: To evaluate sequentially if the immunogenicity (as determined by ELISA) of Cervarix vaccine administered according to a 2-dose schedule of 0,6 months in 9-14 year old females was non-inferior to that administered according to the standard 3-dose schedule of 0,1,6 months in 15-25 year old females, 1 month after the last dose of study vaccine, in initially seronegative subjects.||0.77|-1.00|
72471506|NCT01381575|144466683|NON_INFERIORITY|Non-inferiority with respect to Geometric Mean Concentrations (GMCs) was demonstrated if, 1 month after the last dose, for both anti-HPV-16 and anti-HPV-18, the upper limit of 95% CI for the GMT ratio (Cervarix 2 Group divided by Cervarix 1 Group) was below 2.|Geometric mean ratio|1.09|||||TWO_SIDED|95.0|0.97|1.22||||||Immune response to anti-HPV-16 in terms of Geometric Mean Concentrations (GMCs): To evaluate sequentially if the immunogenicity (as determined by ELISA) of Cervarix vaccine administered according to a 2-dose schedule at 0, 6 months in 9-14 year old females was non-inferior to that administered according to the standard 3-dose schedule of 0,1,6 months in 15-25 year old females, 1 month after the last dose of study vaccine, in initially seronegative subjects.||1.22|0.97|
72471507|NCT01381575|144466683|NON_INFERIORITY|Non-inferiority with respect to Geometric Mean Concentrations (GMCs) was demonstrated if, 1 month after the last dose, for both anti-HPV-16 and anti-HPV-18, the upper limit of 95% CI for the GMT ratio (Cervarix 2 Group divided by Cervarix 1 Group) was below 2.|Geometric mean ratio|0.85|||||TWO_SIDED|95.0|0.76|0.95||||||Immune response to anti-HPV-18 in terms of Geometric Mean Concentrations (GMCs): To evaluate sequentially if the immunogenicity (as determined by ELISA) of Cervarix vaccine administered according to a 2-dose schedule at 0, 6 months in 9-14 year old females was non-inferior to that administered according to the standard 3-dose schedule of 0,1,6 months in 15-25 year old females, 1 month after the last dose of study vaccine, in initially seronegative subjects.||0.95|0.76|
72471508|NCT01443403|144466706|SUPERIORITY_OR_OTHER||LS Mean Difference|2.22|STANDARD_ERROR_OF_MEAN|0.605||0.0003|TWO_SIDED|95.0|1.02|3.41|||ANCOVA|Analysis of covariance (ANCOVA) model with treatment group as a term and baseline value as a covariate.||||3.41|1.02|0.0003
72471509|NCT01443403|144466706|SUPERIORITY_OR_OTHER||LS Mean Difference|1.95|STANDARD_ERROR_OF_MEAN|0.604||0.0014|TWO_SIDED|95.0|0.76|3.14|||ANCOVA|ANCOVA model with treatment group as a term and baseline value as a covariate.||||3.14|0.76|0.0014
72471510|NCT01443403|144466706|SUPERIORITY_OR_OTHER||LS Mean Difference|0.56|STANDARD_ERROR_OF_MEAN|0.599||0.3504|TWO_SIDED|95.0|-0.62|1.74|||ANCOVA|ANCOVA model with treatment group as a term and baseline value as a covariate.||||1.74|-0.62|0.3504
72471511|NCT01443403|144466708|SUPERIORITY_OR_OTHER||LS Mean Difference|1.93|STANDARD_ERROR_OF_MEAN|0.568||0.0008|TWO_SIDED|95.0|0.81|3.05|||ANCOVA|ANCOVA model with treatment group as a term and baseline value as a covariate.||||3.05|0.81|0.0008
72505926|NCT00858702|144543301|SUPERIORITY_OR_OTHER|||||||0.0158||95.0||||No consideration for multiplicity|Fisher Exact|||||||0.0158
72505927|NCT00858702|144543302|SUPERIORITY_OR_OTHER|||||||0.0566||95.0||||No consideration for multiplicity|Fisher Exact|||||||0.0566
72505928|NCT00858702|144543303|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||No consideration for multiplicity|Fisher Exact|||||||<0.001
72471512|NCT01443403|144466708|SUPERIORITY_OR_OTHER||LS Mean Difference|1.91|STANDARD_ERROR_OF_MEAN|0.569||0.0009|TWO_SIDED|95.0|0.79|3.04|||ANCOVA|ANCOVA model with treatment group as a term and baseline value as a covariate.||||3.04|0.79|0.0009
72471513|NCT01443403|144466708|SUPERIORITY_OR_OTHER||LS Mean Difference|0.63|STANDARD_ERROR_OF_MEAN|0.558||0.2572|TWO_SIDED|95.0|-0.47|1.73|||ANCOVA|ANCOVA model with treatment group as a term and baseline value as a covariate.||||1.73|-0.47|0.2572
72471514|NCT01443403|144466710|SUPERIORITY_OR_OTHER||LS Mean Difference|1.33|STANDARD_ERROR_OF_MEAN|0.484||0.0065|TWO_SIDED|95.0|0.38|2.28|||ANCOVA|ANCOVA model with treatment group as a term and baseline value as a covariate.||||2.28|0.38|0.0065
72471515|NCT01443403|144466710|SUPERIORITY_OR_OTHER||LS Mean Difference|1.64|STANDARD_ERROR_OF_MEAN|0.482||0.0008|TWO_SIDED|95.0|0.69|2.58|||ANCOVA|ANCOVA model with treatment group as a term and baseline value as a covariate.||||2.58|0.69|0.0008
72471516|NCT01443403|144466710|SUPERIORITY_OR_OTHER||LS Mean Difference|0.5|STANDARD_ERROR_OF_MEAN|0.476||0.2921|TWO_SIDED|95.0|-0.43|1.44|||ANCOVA|ANCOVA model with treatment group as a term and baseline value as a covariate.||||1.44|-0.43|0.2921
72505929|NCT00062738|144543313|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.7|||<|0.05|TWO_SIDED|95.0|0.8|15.9|||Fisher Exact|||For the responder analysis, an LOCF approach was used in which a clinical response was operationally defined as at least a 50% reduction in the HAM-D score from baseline to 8 weeks. Clinical response was cross-tabulated with treatment and Fisher exact test was used to distinguish differences among these groups.||15.9|0.8|<.05
72395965|NCT01529346|144298352|SUPERIORITY_OR_OTHER||LS Mean Difference|1.02|STANDARD_ERROR_OF_MEAN|0.26|||TWO_SIDED|90.0|0.59|1.45||||||45 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||1.45|0.59|
72395966|NCT01529346|144298352|SUPERIORITY_OR_OTHER||LS Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|0.25|||TWO_SIDED|90.0|-0.21|0.62||||||60 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.62|-0.21|
72395967|NCT01529346|144298352|SUPERIORITY_OR_OTHER||LS Mean Difference|0.34|STANDARD_ERROR_OF_MEAN|0.25|||TWO_SIDED|90.0|-0.07|0.76||||||60 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.76|-0.07|
72395968|NCT01529346|144298352|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|0.25|||TWO_SIDED|90.0|-0.11|0.72||||||60 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.72|-0.11|
72395969|NCT01529346|144298352|SUPERIORITY_OR_OTHER||LS Mean Difference|1.3|STANDARD_ERROR_OF_MEAN|0.27|||TWO_SIDED|90.0|0.85|1.75||||||60 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||1.75|0.85|
72395970|NCT01529346|144298352|SUPERIORITY_OR_OTHER||LS Mean Difference|0.39|STANDARD_ERROR_OF_MEAN|0.26|||TWO_SIDED|90.0|-0.04|0.81||||||90 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.81|-0.04|
72395971|NCT01529346|144298352|SUPERIORITY_OR_OTHER||LS Mean Difference|0.32|STANDARD_ERROR_OF_MEAN|0.26|||TWO_SIDED|90.0|-0.1|0.75||||||90 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.75|-0.10|
72395972|NCT01529346|144298352|SUPERIORITY_OR_OTHER||LS Mean Difference|0.38|STANDARD_ERROR_OF_MEAN|0.26|||TWO_SIDED|90.0|-0.05|0.81||||||90 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.81|-0.05|
72395973|NCT01529346|144298352|SUPERIORITY_OR_OTHER||LS Mean Difference|1.69|STANDARD_ERROR_OF_MEAN|0.28|||TWO_SIDED|90.0|1.22|2.15||||||90 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||2.15|1.22|
72395974|NCT01529346|144298352|SUPERIORITY_OR_OTHER||LS Mean Difference|0.5|STANDARD_ERROR_OF_MEAN|0.3|||TWO_SIDED|90.0|0.01|0.99||||||2 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.99|0.01|
72395975|NCT01529346|144298352|SUPERIORITY_OR_OTHER||LS Mean Difference|0.54|STANDARD_ERROR_OF_MEAN|0.3|||TWO_SIDED|90.0|0.05|1.03||||||2 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||1.03|0.05|
72395976|NCT01529346|144298352|SUPERIORITY_OR_OTHER||LS Mean Difference|0.45|STANDARD_ERROR_OF_MEAN|0.3|||TWO_SIDED|90.0|-0.04|0.94||||||2 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.94|-0.04|
72395977|NCT01529346|144298352|SUPERIORITY_OR_OTHER||LS Mean Difference|1.79|STANDARD_ERROR_OF_MEAN|0.32|||TWO_SIDED|90.0|1.26|2.31||||||2 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||2.31|1.26|
72395978|NCT01529346|144298352|SUPERIORITY_OR_OTHER||LS Mean Difference|0.59|STANDARD_ERROR_OF_MEAN|0.32|||TWO_SIDED|90.0|0.06|1.11||||||3 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||1.11|0.06|
72395979|NCT01529346|144298352|SUPERIORITY_OR_OTHER||LS Mean Difference|0.64|STANDARD_ERROR_OF_MEAN|0.32|||TWO_SIDED|90.0|0.11|1.17||||||3 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||1.17|0.11|
72395980|NCT01529346|144298352|SUPERIORITY_OR_OTHER||LS Mean Difference|0.63|STANDARD_ERROR_OF_MEAN|0.32|||TWO_SIDED|90.0|0.11|1.15||||||3 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||1.15|0.11|
72395981|NCT01529346|144298352|SUPERIORITY_OR_OTHER||LS Mean Difference|1.87|STANDARD_ERROR_OF_MEAN|0.32|||TWO_SIDED|90.0|1.33|2.4||||||3 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||2.40|1.33|
72471517|NCT01443403|144466712|SUPERIORITY_OR_OTHER||LS Mean Difference|1.44|STANDARD_ERROR_OF_MEAN|0.495||0.0039|TWO_SIDED|95.0|0.47|2.42|||ANCOVA|ANCOVA model with treatment group as a term and baseline value as a covariate.||||2.42|0.47|0.0039
72395982|NCT01529346|144298352|SUPERIORITY_OR_OTHER||LS Mean Difference|0.49|STANDARD_ERROR_OF_MEAN|0.34|||TWO_SIDED|90.0|-0.07|1.05||||||4 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||1.05|-0.07|
72395983|NCT01529346|144298352|SUPERIORITY_OR_OTHER||LS Mean Difference|0.33|STANDARD_ERROR_OF_MEAN|0.35|||TWO_SIDED|90.0|-0.24|0.91||||||4 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.91|-0.24|
72622892|NCT02796651|144775944|SUPERIORITY||LSMean difference|0.265|||<|0.001|TWO_SIDED|95.0|0.226|0.304|||Mixed Models Analysis|||||0.304|0.226|<0.001
72622893|NCT02796651|144775944|SUPERIORITY||LSMean difference|0.037||||0.004|TWO_SIDED|95.0|0.012|0.062|||Mixed Models Analysis|||||0.062|0.012|0.004
72395984|NCT01529346|144298352|SUPERIORITY_OR_OTHER||LS Mean Difference|0.43|STANDARD_ERROR_OF_MEAN|0.34|||TWO_SIDED|90.0|-0.13|0.98||||||4 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.98|-0.13|
72395985|NCT01529346|144298352|SUPERIORITY_OR_OTHER||LS Mean Difference|1.61|STANDARD_ERROR_OF_MEAN|0.34|||TWO_SIDED|90.0|1.05|2.17||||||4 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||2.17|1.05|
72395986|NCT01529346|144298352|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.42|||TWO_SIDED|90.0|-0.74|0.64||||||6 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.64|-0.74|
72395987|NCT01529346|144298352|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.43|||TWO_SIDED|90.0|-0.86|0.56||||||6 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.56|-0.86|
72395988|NCT01529346|144298352|SUPERIORITY_OR_OTHER||LS Mean Difference|0.11|STANDARD_ERROR_OF_MEAN|0.42|||TWO_SIDED|90.0|-0.57|0.8||||||6 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.80|-0.57|
72395989|NCT01529346|144298352|SUPERIORITY_OR_OTHER||LS Mean Difference|0.9|STANDARD_ERROR_OF_MEAN|0.41|||TWO_SIDED|90.0|0.22|1.58||||||6 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||1.58|0.22|
72395990|NCT01529346|144298352|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.46|||TWO_SIDED|90.0|-0.93|0.59||||||8 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.59|-0.93|
72622894|NCT02796651|144775944|SUPERIORITY||LSMean difference|0.094|||<|0.001|TWO_SIDED|95.0|0.068|0.119|||Mixed Models Analysis|||||0.119|0.068|<0.001
72622895|NCT02796651|144775944|SUPERIORITY||LSMean difference|0.084|||<|0.001|TWO_SIDED|95.0|0.059|0.11|||Mixed Models Analysis|||||0.110|0.059|<0.001
72622896|NCT02796651|144775944|SUPERIORITY||LSMean difference|0.135|||<|0.001|TWO_SIDED|95.0|0.109|0.161|||Mixed Models Analysis|||||0.161|0.109|<0.001
72622897|NCT02796651|144775944|SUPERIORITY||LSMean difference|0.057|||<|0.001|TWO_SIDED|95.0|0.031|0.082|||Mixed Models Analysis|||||0.082|0.031|<0.001
72622898|NCT02796651|144775944|SUPERIORITY||LSMean difference|0.047|||<|0.001|TWO_SIDED|95.0|0.023|0.071|||Mixed Models Analysis|||||0.071|0.023|<0.001
72471518|NCT01443403|144466712|SUPERIORITY_OR_OTHER||LS Mean Difference|1.7|STANDARD_ERROR_OF_MEAN|0.492||0.0007|TWO_SIDED|95.0|0.73|2.67|||ANCOVA|ANCOVA model with treatment group as a term and baseline value as a covariate.||||2.67|0.73|0.0007
72471519|NCT01443403|144466712|SUPERIORITY_OR_OTHER||LS Mean Difference|0.5|STANDARD_ERROR_OF_MEAN|0.488||0.3077|TWO_SIDED|95.0|-0.46|1.46|||ANCOVA|ANCOVA model with treatment group as a term and baseline value as a covariate.||||1.46|-0.46|0.3077
72471520|NCT01443403|144466714|SUPERIORITY_OR_OTHER||Difference|27.3||||0.003|TWO_SIDED|95.0|10.0|44.6|||Chi-squared|||||44.6|10.0|0.0030
72471521|NCT01443403|144466714|SUPERIORITY_OR_OTHER||Difference|31.8||||0.0005|TWO_SIDED|95.0|15.0|48.7|||Chi-squared|||||48.7|15.0|0.0005
72471522|NCT01443403|144466714|SUPERIORITY_OR_OTHER||Difference|13.1||||0.1461|TWO_SIDED|95.0|-4.4|30.6|||Chi-squared|||||30.6|-4.4|0.1461
72471523|NCT01443403|144466716|SUPERIORITY_OR_OTHER||Difference|24.3||||0.005|TWO_SIDED|95.0|7.8|40.8|||Chi-squared|||||40.8|7.8|0.0050
72471524|NCT01443403|144466716|SUPERIORITY_OR_OTHER||Difference|24.5||||0.0045|TWO_SIDED|95.0|8.1|40.8|||Chi-squared|||||40.8|8.1|0.0045
72471525|NCT01443403|144466716|SUPERIORITY_OR_OTHER||Difference|8.2||||0.2984|TWO_SIDED|95.0|-7.2|23.6|||Chi-squared|||||23.6|-7.2|0.2984
72471526|NCT01443403|144466718|SUPERIORITY_OR_OTHER||LS Mean Difference|1.54|STANDARD_ERROR_OF_MEAN|0.32|<|0.0001|TWO_SIDED|95.0|0.9|2.17|||ANCOVA|ANCOVA model with treatment group as a term and baseline value as a covariate.||||2.17|0.90|<0.0001
72471527|NCT01443403|144466718|SUPERIORITY_OR_OTHER||LS Mean Difference|1.22|STANDARD_ERROR_OF_MEAN|0.32||0.0002|TWO_SIDED|95.0|0.59|1.85|||ANCOVA|ANCOVA model with treatment group as a term and baseline value as a covariate.||||1.85|0.59|0.0002
72471528|NCT01443403|144466718|SUPERIORITY_OR_OTHER||LS Mean Difference|0.58|STANDARD_ERROR_OF_MEAN|0.317||0.0698|TWO_SIDED|95.0|-0.05|1.2|||ANCOVA|ANCOVA model with treatment group as a term and baseline value as a covariate.||||1.20|-0.05|0.0698
72395991|NCT01529346|144298352|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.48|||TWO_SIDED|90.0|-0.98|0.62||||||8 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.62|-0.98|
72395992|NCT01529346|144298352|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.45|||TWO_SIDED|90.0|-1.05|0.45||||||8 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.45|-1.05|
72395993|NCT01529346|144298352|SUPERIORITY_OR_OTHER||LS Mean Difference|0.27|STANDARD_ERROR_OF_MEAN|0.45|||TWO_SIDED|90.0|-0.47|1.02||||||8 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||1.02|-0.47|
72395994|NCT01529346|144298352|SUPERIORITY_OR_OTHER||LS Mean Difference|0.63|STANDARD_ERROR_OF_MEAN|0.29|||TWO_SIDED|90.0|0.15|1.11||||||24 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||1.11|0.15|
72395995|NCT01529346|144298352|SUPERIORITY_OR_OTHER||LS Mean Difference|0.24|STANDARD_ERROR_OF_MEAN|0.3|||TWO_SIDED|90.0|-0.27|0.74||||||24 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.74|-0.27|
72395996|NCT01529346|144298352|SUPERIORITY_OR_OTHER||LS Mean Difference|0.44|STANDARD_ERROR_OF_MEAN|0.28|||TWO_SIDED|90.0|-0.03|0.91||||||24 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.91|-0.03|
72395997|NCT01529346|144298352|SUPERIORITY_OR_OTHER||LS Mean Difference|0.19|STANDARD_ERROR_OF_MEAN|0.29|||TWO_SIDED|90.0|-0.3|0.67||||||24 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.67|-0.30|
72395998|NCT01529346|144298353|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.1|||TWO_SIDED|90.0|-0.19|0.14||||||15 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.14|-0.19|
72395999|NCT01529346|144298353|SUPERIORITY_OR_OTHER||LS Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|0.1|||TWO_SIDED|90.0|0.03|0.37||||||15 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.37|0.03|
72396000|NCT01529346|144298353|SUPERIORITY_OR_OTHER||LS Mean Difference|0.07|STANDARD_ERROR_OF_MEAN|0.1|||TWO_SIDED|90.0|-0.1|0.24||||||15 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.24|-0.10|
72396001|NCT01529346|144298353|SUPERIORITY_OR_OTHER||LS Mean Difference|0.02|STANDARD_ERROR_OF_MEAN|0.11|||TWO_SIDED|90.0|-0.16|0.21||||||15 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.21|-0.16|
72396002|NCT01529346|144298353|SUPERIORITY_OR_OTHER||LS Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|0.15|||TWO_SIDED|90.0|-0.06|0.45||||||30 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.45|-0.06|
72471529|NCT01443403|144466720|SUPERIORITY_OR_OTHER||LS Mean Difference|1.19|STANDARD_ERROR_OF_MEAN|0.307||0.0001|TWO_SIDED|95.0|0.58|1.79|||ANCOVA|ANCOVA model with treatment group as a term and baseline value as a covariate.||||1.79|0.58|0.0001
72471530|NCT01443403|144466720|SUPERIORITY_OR_OTHER||LS Mean Difference|1.1|STANDARD_ERROR_OF_MEAN|0.305||0.0004|TWO_SIDED|95.0|0.49|1.7|||ANCOVA|ANCOVA model with treatment group as a term and baseline value as a covariate.||||1.70|0.49|0.0004
72471531|NCT01443403|144466720|SUPERIORITY_OR_OTHER||LS Mean Difference|0.42|STANDARD_ERROR_OF_MEAN|0.302||0.1648|TWO_SIDED|95.0|-0.17|1.02|||ANCOVA|ANCOVA model with treatment group as a term and baseline value as a covariate.||||1.02|-0.17|0.1648
72471532|NCT01443403|144466722|SUPERIORITY_OR_OTHER|||||||0.0004||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0004
72471533|NCT01443403|144466722|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.0001
72471534|NCT01443403|144466722|SUPERIORITY_OR_OTHER|||||||0.0118||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0118
72471535|NCT01443403|144466723|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.0001
72471536|NCT01443403|144466723|SUPERIORITY_OR_OTHER|||||||0.0011||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0011
72471537|NCT01443403|144466723|SUPERIORITY_OR_OTHER|||||||0.0079||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0079
72471538|NCT01443403|144466726|SUPERIORITY_OR_OTHER||LS Mean Difference|1.33|STANDARD_ERROR_OF_MEAN|0.358||0.0003|TWO_SIDED|95.0|0.62|2.03|||ANCOVA|ANCOVA model with treatment group as a term and baseline value as a covariate.||||2.03|0.62|0.0003
72471539|NCT01443403|144466726|SUPERIORITY_OR_OTHER||LS Mean Difference|1.51|STANDARD_ERROR_OF_MEAN|0.359|<|0.0001|TWO_SIDED|95.0|0.8|2.22|||ANCOVA|ANCOVA model with treatment group as a term and baseline value as a covariate.||||2.22|0.80|<0.0001
72396003|NCT01529346|144298353|SUPERIORITY_OR_OTHER||LS Mean Difference|0.44|STANDARD_ERROR_OF_MEAN|0.15|||TWO_SIDED|90.0|0.19|0.7||||||30 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.70|0.19|
72565672|NCT02709486|144662692|SUPERIORITY||Odds Ratio (OR)|1.87||||0.0003|TWO_SIDED|95.0|1.33|2.64|||Regression, Logistic|||Week 16, \>=50%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.64|1.33|0.0003
72565673|NCT02709486|144662692|SUPERIORITY||Odds Ratio (OR)|1.68||||0.003|TWO_SIDED|95.0|1.19|2.36|||Regression, Logistic|||Week 16, \>=50%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.36|1.19|0.0030
72396004|NCT01529346|144298353|SUPERIORITY_OR_OTHER||LS Mean Difference|0.29|STANDARD_ERROR_OF_MEAN|0.15|||TWO_SIDED|90.0|0.04|0.54||||||30 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.54|0.04|
72396005|NCT01529346|144298353|SUPERIORITY_OR_OTHER||LS Mean Difference|0.59|STANDARD_ERROR_OF_MEAN|0.17|||TWO_SIDED|90.0|0.32|0.87||||||30 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.87|0.32|
72396006|NCT01529346|144298353|SUPERIORITY_OR_OTHER||LS Mean Difference|0.12|STANDARD_ERROR_OF_MEAN|0.17|||TWO_SIDED|90.0|-0.16|0.4||||||45 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.40|-0.16|
72396007|NCT01529346|144298353|SUPERIORITY_OR_OTHER||LS Mean Difference|0.4|STANDARD_ERROR_OF_MEAN|0.17|||TWO_SIDED|90.0|0.12|0.68||||||45 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.68|0.12|
72396008|NCT01529346|144298353|SUPERIORITY_OR_OTHER||LS Mean Difference|0.23|STANDARD_ERROR_OF_MEAN|0.17|||TWO_SIDED|90.0|-0.05|0.5||||||45 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.50|-0.05|
72396009|NCT01529346|144298353|SUPERIORITY_OR_OTHER||LS Mean Difference|0.71|STANDARD_ERROR_OF_MEAN|0.18|||TWO_SIDED|90.0|0.4|1.01||||||45 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||1.01|0.40|
72396010|NCT01529346|144298353|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.18|||TWO_SIDED|90.0|-0.19|0.4||||||60 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.40|-0.19|
72396011|NCT01529346|144298353|SUPERIORITY_OR_OTHER||LS Mean Difference|0.19|STANDARD_ERROR_OF_MEAN|0.18|||TWO_SIDED|90.0|-0.1|0.49||||||60 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.49|-0.10|
72396012|NCT01529346|144298353|SUPERIORITY_OR_OTHER||LS Mean Difference|0.13|STANDARD_ERROR_OF_MEAN|0.18|||TWO_SIDED|90.0|-0.16|0.43||||||60 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.43|-0.16|
72396013|NCT01529346|144298353|SUPERIORITY_OR_OTHER||LS Mean Difference|0.74|STANDARD_ERROR_OF_MEAN|0.2|||TWO_SIDED|90.0|0.41|1.06||||||60 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||1.06|0.41|
72396014|NCT01529346|144298353|SUPERIORITY_OR_OTHER||LS Mean Difference|0.33|STANDARD_ERROR_OF_MEAN|0.19|||TWO_SIDED|90.0|0.01|0.64||||||90 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.64|0.01|
72396015|NCT01529346|144298353|SUPERIORITY_OR_OTHER||LS Mean Difference|0.31|STANDARD_ERROR_OF_MEAN|0.19|||TWO_SIDED|90.0|-0.01|0.62||||||90 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.62|-0.01|
72471540|NCT01443403|144466726|SUPERIORITY_OR_OTHER||LS Mean Difference|0.55|STANDARD_ERROR_OF_MEAN|0.352||0.1211|TWO_SIDED|95.0|-0.15|1.24|||ANCOVA|ANCOVA model with treatment group as a term and baseline value as a covariate.||||1.24|-0.15|0.1211
72471541|NCT01443403|144466728|SUPERIORITY_OR_OTHER||LS Mean Difference|2.36|STANDARD_ERROR_OF_MEAN|0.551|<|0.0001|TWO_SIDED|95.0|1.28|3.45|||ANCOVA|ANCOVA model with treatment group as a term and baseline value as a covariate.||||3.45|1.28|<0.0001
72471542|NCT01443403|144466728|SUPERIORITY_OR_OTHER||LS Mean Difference|2.07|STANDARD_ERROR_OF_MEAN|0.549||0.0002|TWO_SIDED|95.0|0.99|3.15|||ANCOVA|ANCOVA model with treatment group as a term and baseline value as a covariate.||||3.15|0.99|0.0002
72396016|NCT01529346|144298353|SUPERIORITY_OR_OTHER||LS Mean Difference|0.39|STANDARD_ERROR_OF_MEAN|0.19|||TWO_SIDED|90.0|0.08|0.71||||||90 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.71|0.08|
72396017|NCT01529346|144298353|SUPERIORITY_OR_OTHER||LS Mean Difference|1.26|STANDARD_ERROR_OF_MEAN|0.21|||TWO_SIDED|90.0|0.92|1.61||||||90 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||1.61|0.92|
72396018|NCT01529346|144298353|SUPERIORITY_OR_OTHER||LS Mean Difference|0.4|STANDARD_ERROR_OF_MEAN|0.22|||TWO_SIDED|90.0|0.04|0.76||||||2 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.76|0.04|
72396019|NCT01529346|144298353|SUPERIORITY_OR_OTHER||LS Mean Difference|0.33|STANDARD_ERROR_OF_MEAN|0.22|||TWO_SIDED|90.0|-0.03|0.69||||||2 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.69|-0.03|
72396020|NCT01529346|144298353|SUPERIORITY_OR_OTHER||LS Mean Difference|0.41|STANDARD_ERROR_OF_MEAN|0.22|||TWO_SIDED|90.0|0.05|0.77||||||2 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.77|0.05|
72565674|NCT02709486|144662692|SUPERIORITY||Odds Ratio (OR)|1.47||||0.0754|TWO_SIDED|95.0|0.96|2.24|||Regression, Logistic|||Week 16, \>=70%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.24|0.96|0.0754
72565675|NCT02709486|144662692|SUPERIORITY||Odds Ratio (OR)|1.61||||0.0253|TWO_SIDED|95.0|1.06|2.44|||Regression, Logistic|||Week 16, \>=70%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.44|1.06|0.0253
72565676|NCT02709486|144662692|SUPERIORITY||Odds Ratio (OR)|2.98||||0.0098|TWO_SIDED|95.0|1.3|6.83|||Regression, Logistic|||Week 16, \>=90%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||6.83|1.30|0.0098
72565677|NCT02709486|144662692|SUPERIORITY||Odds Ratio (OR)|1.72||||0.223|TWO_SIDED|95.0|0.72|4.13|||Regression, Logistic|||Week 16, \>=90%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||4.13|0.72|0.2230
72565678|NCT02709486|144662692|SUPERIORITY||Odds Ratio (OR)|1.5||||0.0201|TWO_SIDED|95.0|1.07|2.12|||Regression, Logistic|||Week 24, \>=30%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.12|1.07|0.0201
72565679|NCT02709486|144662692|SUPERIORITY||Odds Ratio (OR)|1.73||||0.0021|TWO_SIDED|95.0|1.22|2.44|||Regression, Logistic|||Week 24, \>=30%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.44|1.22|0.0021
72396021|NCT01529346|144298353|SUPERIORITY_OR_OTHER||LS Mean Difference|1.3|STANDARD_ERROR_OF_MEAN|0.23|||TWO_SIDED|90.0|0.92|1.68||||||2 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||1.68|0.92|
72396022|NCT01529346|144298353|SUPERIORITY_OR_OTHER||LS Mean Difference|0.55|STANDARD_ERROR_OF_MEAN|0.24|||TWO_SIDED|90.0|0.16|0.95||||||3 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.95|0.16|
72565680|NCT02709486|144662692|SUPERIORITY||Odds Ratio (OR)|1.72||||0.0022|TWO_SIDED|95.0|1.22|2.43|||Regression, Logistic|||Week 24, \>=50%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.43|1.22|0.0022
72565681|NCT02709486|144662692|SUPERIORITY||Odds Ratio (OR)|1.87||||0.0004|TWO_SIDED|95.0|1.32|2.64|||Regression, Logistic|||Week 24, \>=50%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.64|1.32|0.0004
72622899|NCT02796651|144775944|SUPERIORITY||LSMean difference|0.098|||<|0.001|TWO_SIDED|95.0|0.073|0.123|||Mixed Models Analysis|||||0.123|0.073|<0.001
72396023|NCT01529346|144298353|SUPERIORITY_OR_OTHER||LS Mean Difference|0.57|STANDARD_ERROR_OF_MEAN|0.24|||TWO_SIDED|90.0|0.17|0.97||||||3 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.97|0.17|
72622900|NCT02796651|144775944|SUPERIORITY||LSMean difference|-0.009||||0.469|TWO_SIDED|95.0|-0.035|0.016|||Mixed Models Analysis|||||0.016|-0.035|0.469
72622901|NCT02796651|144775944|SUPERIORITY||LSMean difference|0.041||||0.002|TWO_SIDED|95.0|0.015|0.068|||Mixed Models Analysis|||||0.068|0.015|0.002
72622902|NCT02796651|144775944|SUPERIORITY||LSMean difference|0.051|||<|0.001|TWO_SIDED|95.0|0.025|0.076|||Mixed Models Analysis|||||0.076|0.025|<0.001
72396024|NCT01529346|144298353|SUPERIORITY_OR_OTHER||LS Mean Difference|0.63|STANDARD_ERROR_OF_MEAN|0.24|||TWO_SIDED|90.0|0.24|1.03||||||3 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||1.03|0.24|
72396025|NCT01529346|144298353|SUPERIORITY_OR_OTHER||LS Mean Difference|1.38|STANDARD_ERROR_OF_MEAN|0.24|||TWO_SIDED|90.0|0.97|1.78||||||3 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||1.78|0.97|
72396026|NCT01529346|144298353|SUPERIORITY_OR_OTHER||LS Mean Difference|0.5|STANDARD_ERROR_OF_MEAN|0.25|||TWO_SIDED|90.0|0.08|0.92||||||4 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.92|0.08|
72396027|NCT01529346|144298353|SUPERIORITY_OR_OTHER||LS Mean Difference|0.41|STANDARD_ERROR_OF_MEAN|0.26|||TWO_SIDED|90.0|-0.03|0.84||||||4 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.84|-0.03|
72396028|NCT01529346|144298353|SUPERIORITY_OR_OTHER||LS Mean Difference|0.51|STANDARD_ERROR_OF_MEAN|0.25|||TWO_SIDED|90.0|0.09|0.93||||||4 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.93|0.09|
72396029|NCT01529346|144298353|SUPERIORITY_OR_OTHER||LS Mean Difference|1.17|STANDARD_ERROR_OF_MEAN|0.25|||TWO_SIDED|90.0|0.75|1.59||||||4 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||1.59|0.75|
72396030|NCT01529346|144298353|SUPERIORITY_OR_OTHER||LS Mean Difference|0.23|STANDARD_ERROR_OF_MEAN|0.3|||TWO_SIDED|90.0|-0.27|0.72||||||6 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.72|-0.27|
72396031|NCT01529346|144298353|SUPERIORITY_OR_OTHER||LS Mean Difference|0.14|STANDARD_ERROR_OF_MEAN|0.31|||TWO_SIDED|90.0|-0.37|0.65||||||6 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.65|-0.37|
72396032|NCT01529346|144298353|SUPERIORITY_OR_OTHER||LS Mean Difference|0.27|STANDARD_ERROR_OF_MEAN|0.3|||TWO_SIDED|90.0|-0.23|0.77||||||6 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.77|-0.23|
72396033|NCT01529346|144298353|SUPERIORITY_OR_OTHER||LS Mean Difference|0.82|STANDARD_ERROR_OF_MEAN|0.3|||TWO_SIDED|90.0|0.33|1.31||||||6 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||1.31|0.33|
72396034|NCT01529346|144298353|SUPERIORITY_OR_OTHER||LS Mean Difference|0.32|STANDARD_ERROR_OF_MEAN|0.34|||TWO_SIDED|90.0|-0.24|0.89||||||8 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.89|-0.24|
72565682|NCT02709486|144662692|SUPERIORITY||Odds Ratio (OR)|1.32||||0.2031|TWO_SIDED|95.0|0.86|2.01|||Regression, Logistic|||Week 24, \>=70%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.01|0.86|0.2031
72396035|NCT01529346|144298353|SUPERIORITY_OR_OTHER||LS Mean Difference|0.34|STANDARD_ERROR_OF_MEAN|0.36|||TWO_SIDED|90.0|-0.25|0.94||||||8 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.94|-0.25|
72396036|NCT01529346|144298353|SUPERIORITY_OR_OTHER||LS Mean Difference|0.25|STANDARD_ERROR_OF_MEAN|0.34|||TWO_SIDED|90.0|-0.31|0.8||||||8 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.80|-0.31|
72396037|NCT01529346|144298353|SUPERIORITY_OR_OTHER||LS Mean Difference|0.64|STANDARD_ERROR_OF_MEAN|0.33|||TWO_SIDED|90.0|0.08|1.19||||||8 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||1.19|0.08|
72396038|NCT01529346|144298353|SUPERIORITY_OR_OTHER||LS Mean Difference|0.45|STANDARD_ERROR_OF_MEAN|0.23|||TWO_SIDED|90.0|0.07|0.83||||||24 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.83|0.07|
72565683|NCT02709486|144662692|SUPERIORITY||Odds Ratio (OR)|1.44||||0.0867|TWO_SIDED|95.0|0.95|2.18|||Regression, Logistic|||Week 24, \>=70%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.18|0.95|0.0867
72396039|NCT01529346|144298353|SUPERIORITY_OR_OTHER||LS Mean Difference|0.04|STANDARD_ERROR_OF_MEAN|0.24|||TWO_SIDED|90.0|-0.36|0.44||||||24 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.44|-0.36|
72396040|NCT01529346|144298353|SUPERIORITY_OR_OTHER||LS Mean Difference|0.31|STANDARD_ERROR_OF_MEAN|0.22|||TWO_SIDED|90.0|-0.07|0.68||||||24 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.68|-0.07|
72396041|NCT01529346|144298353|SUPERIORITY_OR_OTHER||LS Mean Difference|0.06|STANDARD_ERROR_OF_MEAN|0.23|||TWO_SIDED|90.0|-0.32|0.45||||||24 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.45|-0.32|
72396042|NCT01529346|144298354|SUPERIORITY_OR_OTHER||LS Mean Difference|2.07|STANDARD_ERROR_OF_MEAN|0.99|||TWO_SIDED|90.0|0.43|3.71||||||SPID(6): LS mean estimate of the treatment difference along with 90% confidence interval (CI) were based on an ANCOVA model included treatment as a fixed effect and baseline pain intensity as a covariate.||3.71|0.43|
72396043|NCT01529346|144298354|SUPERIORITY_OR_OTHER||LS Mean Difference|1.69|STANDARD_ERROR_OF_MEAN|0.99|||TWO_SIDED|90.0|0.05|3.33||||||SPID(6): LS mean estimate of the treatment difference along with 90% CI were based on an ANCOVA model included treatment as a fixed effect and baseline pain intensity as a covariate.||3.33|0.05|
72396044|NCT01529346|144298354|SUPERIORITY_OR_OTHER||LS Mean Difference|2.34|STANDARD_ERROR_OF_MEAN|1.0|||TWO_SIDED|90.0|0.69|3.99||||||SPID(6): LS mean estimate of the treatment difference along with 90% CI were based on an ANCOVA model included treatment as a fixed effect and baseline pain intensity as a covariate.||3.99|0.69|
72396045|NCT01529346|144298354|SUPERIORITY_OR_OTHER||LS Mean Difference|6.99|STANDARD_ERROR_OF_MEAN|1.09|||TWO_SIDED|90.0|5.19|8.79||||||SPID(6): LS mean estimate of the treatment difference along with 90% CI were based on an ANCOVA model included treatment as a fixed effect and baseline pain intensity as a covariate.||8.79|5.19|
72396046|NCT01529346|144298354|SUPERIORITY_OR_OTHER||LS Mean Difference|9.8|STANDARD_ERROR_OF_MEAN|4.74|||TWO_SIDED|90.0|1.97|17.63||||||SPID(24): LS mean estimate of the treatment difference along with 90% CI were based on an ANCOVA model included treatment as a fixed effect and baseline pain intensity as a covariate.||17.63|1.97|
72396047|NCT01529346|144298354|SUPERIORITY_OR_OTHER||LS Mean Difference|3.55|STANDARD_ERROR_OF_MEAN|4.74|||TWO_SIDED|90.0|-4.28|11.37||||||SPID(24): LS mean estimate of the treatment difference along with 90% CI were based on an ANCOVA model included treatment as a fixed effect and baseline pain intensity as a covariate.||11.37|-4.28|
72396048|NCT01529346|144298354|SUPERIORITY_OR_OTHER||LS Mean Difference|10.82|STANDARD_ERROR_OF_MEAN|4.76|||TWO_SIDED|90.0|2.97|18.68||||||SPID(24): LS mean estimate of the treatment difference along with 90% CI were based on an ANCOVA model included treatment as a fixed effect and baseline pain intensity as a covariate.||18.68|2.97|
72396049|NCT01529346|144298354|SUPERIORITY_OR_OTHER||LS Mean Difference|22.39|STANDARD_ERROR_OF_MEAN|5.19|||TWO_SIDED|90.0|13.82|30.97||||||SPID(24): LS mean estimate of the treatment difference along with 90% CI were based on an ANCOVA model included treatment as a fixed effect and baseline pain intensity as a covariate.||30.97|13.82|
72565684|NCT02709486|144662692|SUPERIORITY||Odds Ratio (OR)|1.8||||0.1746|TWO_SIDED|95.0|0.77|4.22|||Regression, Logistic|||Week 24, \>=90%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||4.22|0.77|0.1746
72396050|NCT01529346|144298355|SUPERIORITY_OR_OTHER||LS Mean Difference|12.26|STANDARD_ERROR_OF_MEAN|6.66|||TWO_SIDED|90.0|1.26|23.27||||||LS mean estimate of the treatment difference along with 90% CI were based on an ANCOVA model including treatment as a fixed effect and baseline pain intensity as a covariate.||23.27|1.26|
72396051|NCT01529346|144298355|SUPERIORITY_OR_OTHER||LS Mean Difference|4.18|STANDARD_ERROR_OF_MEAN|6.66|||TWO_SIDED|90.0|-6.82|15.18||||||LS mean estimate of the treatment difference along with 90% CI were based on an ANCOVA model including treatment as a fixed effect and baseline pain intensity as a covariate.||15.18|-6.82|
72396052|NCT01529346|144298355|SUPERIORITY_OR_OTHER||LS Mean Difference|12.57|STANDARD_ERROR_OF_MEAN|6.69|||TWO_SIDED|90.0|1.52|23.61||||||||23.61|1.52|
72396053|NCT01529346|144298355|SUPERIORITY_OR_OTHER||LS Mean Difference|32.56|STANDARD_ERROR_OF_MEAN|7.3|||TWO_SIDED|90.0|20.51|44.61||||||||44.61|20.51|
72396054|NCT01529346|144298356|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.0|||||TWO_SIDED|90.0|0.6|1.5||||||Hazard Ratio (HR) estimates of the treatment difference along with 90% CI were based on Cox proportional hazards model including treatment and baseline pain intensity as fixed effects.||1.5|0.6|
72396055|NCT01529346|144298356|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.3|||||TWO_SIDED|90.0|0.9|1.9||||||HR estimates of the treatment difference along with 90% CI were based on Cox proportional hazards model including treatment and baseline pain intensity as fixed effects.||1.9|0.9|
72396056|NCT01529346|144298356|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.1|||||TWO_SIDED|90.0|0.7|1.6||||||HR estimates of the treatment difference along with 90% CI were based on Cox proportional hazards model including treatment and baseline pain intensity as fixed effects.||1.6|0.7|
72396057|NCT01529346|144298356|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.6|||||TWO_SIDED|90.0|1.0|2.4||||||HR estimates of the treatment difference along with 90% CI were based on Cox proportional hazards model including treatment and baseline pain intensity as fixed effects.||2.4|1.0|
72396058|NCT01529346|144298357|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.0|||||TWO_SIDED|90.0|1.1|3.8||||||HR estimates of the treatment difference along with 90% CI were based on Cox proportional hazards model including treatment and baseline pain intensity as fixed effects.||3.8|1.1|
72396059|NCT01529346|144298357|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.6|||||TWO_SIDED|90.0|1.4|4.9||||||HR estimates of the treatment difference along with 90% CI were based on Cox proportional hazards model including treatment and baseline pain intensity as fixed effects.||4.9|1.4|
72622903|NCT02796651|144775945|SUPERIORITY||LSMean difference|0.159|||<|0.001|TWO_SIDED|95.0|0.105|0.213|||Mixed Models Analysis|||||0.213|0.105|<0.001
72622904|NCT02796651|144775945|SUPERIORITY||LSMean difference|0.17|||<|0.001|TWO_SIDED|95.0|0.116|0.224|||Mixed Models Analysis|||||0.224|0.116|<0.001
72396060|NCT01529346|144298357|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.2|||||TWO_SIDED|90.0|1.1|4.1||||||HR estimates of the treatment difference along with 90% CI were based on Cox proportional hazards model including treatment and baseline pain intensity as fixed effects.||4.1|1.1|
72396061|NCT01529346|144298357|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|5.3|||||TWO_SIDED|90.0|2.8|9.9||||||HR estimates of the treatment difference along with 90% CI were based on Cox proportional hazards model including treatment and baseline pain intensity as fixed effects.||9.9|2.8|
72396062|NCT01529346|144298358|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.6|||||TWO_SIDED|90.0|0.4|1.0||||||HR estimates of the treatment difference along with 90% CI were based on Cox proportional hazards model including treatment and baseline pain intensity as fixed effects.||1.0|0.4|
72396063|NCT01529346|144298358|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.8|||||TWO_SIDED|90.0|0.5|1.2||||||HR estimates of the treatment difference along with 90% CI were based on Cox proportional hazards model including treatment and baseline pain intensity as fixed effects.||1.2|0.5|
72396064|NCT01529346|144298358|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.5|||||TWO_SIDED|90.0|0.3|0.8||||||HR estimates of the treatment difference along with 90% CI were based on Cox proportional hazards model including treatment and baseline pain intensity as fixed effects.||0.8|0.3|
72396065|NCT01529346|144298358|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.4|||||TWO_SIDED|90.0|0.2|0.6||||||HR estimates of the treatment difference along with 90% CI were based on Cox proportional hazards model including treatment and baseline pain intensity as fixed effects.||0.6|0.2|
72396066|NCT00106392|144298367|SUPERIORITY_OR_OTHER|||||||0.111||95.0||||P-Values were not adjusted.|Wilcoxon (Mann-Whitney)|||A group sequential design using the O'Brien and Fleming stopping rule will require 58 evaluable patients per group to detect a 5-point difference in the Erectile Function domain of the IIEF with a power of 80% and an overall significance level of 5%.||||0.111
72565685|NCT02709486|144662692|SUPERIORITY||Odds Ratio (OR)|1.99||||0.1039|TWO_SIDED|95.0|0.87|4.57|||Regression, Logistic|||Week 24, \>=90%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||4.57|0.87|0.1039
72565686|NCT02709486|144662693|SUPERIORITY||Odds Ratio (OR)|1.89||||0.0003|TWO_SIDED|95.0|1.33|2.68|||Regression, Logistic|||Week 2, \>=30%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.68|1.33|0.0003
72396067|NCT00106392|144298368|SUPERIORITY_OR_OTHER|||||||0.453||95.0|||||Fisher Exact|||||||0.453
72396068|NCT00106392|144298369|SUPERIORITY_OR_OTHER|||||||0.79||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.790
72396069|NCT00106392|144298370|SUPERIORITY_OR_OTHER|||||||0.099||95.0|||||Fisher Exact|||||||0.099
72396070|NCT00106392|144298371|SUPERIORITY_OR_OTHER|||||||0.575||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.575
72396071|NCT00106392|144298372|SUPERIORITY_OR_OTHER|||||||0.879||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.879
72396072|NCT00589914|144298373|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin was 5 points in the change in PANSS total score i.e., lower limit of the 95% CI for difference between groups (RISPERDAL CONSTA minus paliperidone palmitate) had to be greater than -5 to demonstrate non-inferiority.|Mean Difference (Final Values)|0.4|STANDARD_ERROR_OF_MEAN|1.02|||TWO_SIDED|95.0|-1.62|2.38||No p-value to report.|ANCOVA|ANCOVA model with factors treatment, country and baseline score. Weighted approach used to account for interim analysis for sample size re-estimation.||Null hypothesis: Difference between groups (RISPERDAL CONSTA minus paliperidone palmitate) for the mean change from baseline to endpoint in PANSS total score (LOCF) was less than or equal to -5 (prespecified non-inferiority margin). Sample size: SD of 20 for the change in PANSS total score, a true difference between treatment groups of 0.1 in favor of RISPERDAL CONSTA, 2-sided significance level of 5%, and 80% power. A sample size reestimation was performed when 60% of the data was available.||2.38|-1.62|
72622905|NCT02796651|144775945|SUPERIORITY||LSMean difference|0.219|||<|0.001|TWO_SIDED|95.0|0.163|0.274|||Mixed Models Analysis|||||0.274|0.163|<0.001
72396073|NCT00589914|144298374|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.06|||TWO_SIDED|95.0|-0.07|0.17||No P-values reported.|ANCOVA|||The change from baseline was analyzed using an ANCOVA model with factors for treatment and country and baseline score as a covariate.||0.17|-0.07|
72396074|NCT00589914|144298375|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|0.74|||TWO_SIDED|95.0|-1.22|1.69||No P-values reported.|ANCOVA|||The change from baseline was analyzed using an ANCOVA model with factors for treatment and country and baseline score as a covariate.||1.69|-1.22|
72396075|NCT01737944|144298378|NON_INFERIORITY_OR_EQUIVALENCE|The bioequivalence of Methotrexate following Treatment A - SC injection with the Vibex MTX device and Treatment B - SC injection without the device was established if the 90% CI for the geometric LS Mean ratios of AUC(0-inf)/Dose were within the range of 80% to 125%.|Test / Reference Ratio|96.24|||||TWO_SIDED|90.0|92.33|100.31||||||||100.31|92.33|
72396076|NCT01737944|144298378|NON_INFERIORITY_OR_EQUIVALENCE|The bioequivalence of Methotrexate following Treatment A-SC injection with the Vibex MTX device and Treatment C-IM injection was established if the 90% CI for the geometric LS Mean ratios of AUC(0-inf)/Dose were within the range of 80% to 125%.|Test / Reference Ratio|101.28|||||TWO_SIDED|90.0|97.17|105.56||||||||105.56|97.17|
72396077|NCT01737944|144298379|NON_INFERIORITY_OR_EQUIVALENCE|The bioequivalence of Methotrexate following Treatment A-SC injection with the Vibex MTX device and Treatment B-SC injection was established if the 90% CI for the geometric LS Mean ratios of AUC(0-24)/Dose were within the range of 80% to 125%.|Test / Reference Ratio|96.22|||||TWO_SIDED|90.0|92.32|100.28||||||||100.28|92.32|
72396078|NCT01737944|144298379|NON_INFERIORITY_OR_EQUIVALENCE|The bioequivalence of Methotrexate following Treatment A-SC injection with the Vibex MTX device and Treatment C-IM injection was established if the 90% CI for the geometric LS Mean ratios of AUC(0-24)/Dose were within the range of 80% to 125%.|Test / Reference Ratio|101.14|||||TWO_SIDED|90.0|97.06|105.4||||||||105.40|97.06|
72565687|NCT02709486|144662693|SUPERIORITY||Odds Ratio (OR)|1.48||||0.0286|TWO_SIDED|95.0|1.04|2.1|||Regression, Logistic|||Week 2, \>=30%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.10|1.04|0.0286
72622906|NCT02796651|144775945|SUPERIORITY||LSMean difference|0.179|||<|0.001|TWO_SIDED|95.0|0.125|0.233|||Mixed Models Analysis|||||0.233|0.125|<0.001
72396079|NCT01737944|144298380|NON_INFERIORITY_OR_EQUIVALENCE|The bioequivalence of Methotrexate following Treatment A-SC injection with the Vibex MTX device and Treatment B-SC injection without the device was established if the 90% CI for the geometric LS Mean ratios of Cmax/Dose were within the range of 80% to 125%.|Test / Reference Ratio|96.76|||||TWO_SIDED|90.0|87.93|106.47||||||||106.47|87.93|
72396080|NCT01737944|144298380|NON_INFERIORITY_OR_EQUIVALENCE|The bioequivalence of Methotrexate following Treatment A-SC injection with the Vibex MTX device and Treatment C-IM injection was established if the 90% CI for the geometric LS Mean ratios of Cmax/Dose were within the range of 80% to 125%.|Test / Reference Ratio|89.79|||||TWO_SIDED|90.0|81.61|98.78||||||||98.78|81.61|
72396081|NCT00010374|144298398|OTHER|Performance goal of 35%|Exact two-sided binomial test|96.2|||<|0.001|TWO_SIDED|95.0|87.0|99.5|||Exact two-sided binomial test|||||99.5|87.0|<0.001
72396082|NCT01669915|144298433|SUPERIORITY||Mean Difference (Net)|0.01||||0.31|TWO_SIDED|95.0|-0.01|0.02|||Mixed Models Analysis|||The rates of cognitive decline over 2.8 years were compared in the two groups (rate in vitamin D active group minus the rate in placebo group). A mixed model included terms for the variables time since randomization, assignment to one arm, assignment to the other arm, sex, age, race/ethnicity, history of depression and the six interaction terms (products with time since randomization).||0.02|-0.01|0.31
72396083|NCT01669915|144298433|SUPERIORITY||Mean Difference (Net)|-0.01||||0.14|TWO_SIDED|95.0|-0.02|0.003|||Mixed Models Analysis|||The rates of cognitive decline over 2.8 years were compared in the two groups (rate in omega-3 fatty acids active group minus the rate in placebo group). A mixed model included the variables, time since randomization, assignment to one arm, assignment to the other arm, sex, age, race/ethnicity, history of depression and the six interaction terms (products with time since randomization).||0.003|-0.02|0.14
72396084|NCT01669915|144298434|SUPERIORITY||Mean Difference (Net)|0.01||||0.49|TWO_SIDED|95.0|-0.01|0.03||Given the 3 secondary analyses, the p-value threshold was 0.0167 (=Bonferroni correction of 0.05/3=0.0167).|Mixed Models Analysis|||The rates of cognitive decline over 2.8 years were compared in the two groups (rate in vitamin D active group minus the rate in placebo group). A mixed model included the variables, time since randomization, assignment to one arm, assignment to the other arm, sex, age, race/ethnicity, history of depression and the six interaction terms (products with time since randomization).||0.03|-0.01|0.49
72396085|NCT01669915|144298434|SUPERIORITY||Mean Difference (Net)|-0.02||||0.03|TWO_SIDED|95.0|-0.04|-0.002||Given the 3 secondary analyses, the p-value threshold was 0.0167 (=Bonferroni correction of 0.05/3=0.0167).|Mixed Models Analysis|||The rates of cognitive decline over 2.8 years were compared in the two groups (rate in omega-3 active group minus the rate in placebo group). A mixed model included the variables, time since randomization, assignment to one arm, assignment to the other arm, sex, age, race/ethnicity, history of depression and the six interaction terms (products with time since randomization).||-0.002|-0.04|0.03
72396086|NCT01669915|144298435|SUPERIORITY||Mean Difference (Net)|0.01||||0.23|TWO_SIDED|95.0|-0.01|0.02||Given the 3 secondary analyses, the p-value threshold was 0.0167 (=Bonferroni correction of 0.05/3=0.0167).|Mixed Models Analysis|||The rates of cognitive decline over 2.8 years were compared in the two groups (rate in vitamin D active group minus the rate in placebo group). A mixed model included terms for the variables time since randomization, assignment to one arm, assignment to the other arm, sex, age, race/ethnicity, history of depression and the six interaction terms (products with time since randomization).||0.02|-0.01|0.23
72396087|NCT01669915|144298435|SUPERIORITY||Mean Difference (Net)|0.003||||0.68|TWO_SIDED|95.0|-0.01|0.02||Given the 3 secondary analyses, the p-value threshold was 0.0167 (=Bonferroni correction of 0.05/3=0.0167).|Mixed Models Analysis|||The rates of cognitive decline over 2.8 years were compared in the two groups (rate in omega-3 active group minus the rate in placebo group). A mixed model included terms for the variables time since randomization, assignment to one arm, assignment to the other arm, sex, age, race/ethnicity, history of depression and the six interaction terms (products with time since randomization)||0.02|-0.01|0.68
72396088|NCT01669915|144298436|SUPERIORITY||Mean Difference (Net)|0.03||||0.46|TWO_SIDED|95.0|-0.04|0.09||Given the 3 secondary analyses, the p-value threshold was 0.0167 (=Bonferroni correction of 0.05/3=0.0167).|Mixed Models Analysis|||The rates of cognitive decline over 2.8 years were compared in the two groups (rate in vitamin D active group minus the rate in placebo group). A mixed model included the variables, time since randomization, assignment to one arm, assignment to the other arm, sex, age, race/ethnicity, history of depression and the six interaction terms (products with time since randomization).||0.09|-0.04|0.46
72396089|NCT01669915|144298436|SUPERIORITY||Mean Difference (Net)|-0.1||||0.003|TWO_SIDED|95.0|-0.17|-0.04||Given the 3 secondary analyses, the p-value threshold was 0.0167 (=Bonferroni correction of 0.05/3=0.0167).|Mixed Models Analysis|||The rates of cognitive decline over 2.8 years were compared in the two groups (rate in omega-3 active group minus the rate in placebo group). A mixed model included the variables, time since randomization, assignment to one arm, assignment to the other arm, sex, age, race/ethnicity, history of depression and the six interaction terms (products with time since randomization).||-0.04|-0.17|0.003
72396090|NCT00372112|144298439|SUPERIORITY||Mean Difference (Net)|2.11|||||TWO_SIDED|95.0|-3.48|7.7||||||Placebo versus GW642444 100 mcg once daily for 0-4 h at Day 1.||7.70|-3.48|
72396091|NCT00372112|144298439|SUPERIORITY||Mean Difference (Net)|5.33|||||TWO_SIDED|95.0|-0.41|11.07||||||Placebo versus GW642444 400 mcg once daily for 0-4 h at Day 1.||11.07|-0.41|
72396092|NCT00372112|144298439|SUPERIORITY||Mean Difference (Net)|2.49|||||TWO_SIDED|95.0|-3.35|8.33||||||Placebo versus Salmeterol 50 mcg BD for 0-4 h at Day 1.||8.33|-3.35|
72396093|NCT00372112|144298439|SUPERIORITY||Mean Difference (Net)|-0.38|||||TWO_SIDED|95.0|-6.11|5.36||||||Placebo versus GW642444 100 mcg once daily for 0-4 h at Day 2.||5.36|-6.11|
72396094|NCT00372112|144298439|SUPERIORITY||Mean Difference (Net)|4.36|||||TWO_SIDED|95.0|-1.57|10.29||||||Placebo versus GW642444 400 mcg once daily for 0-4 h at Day 2.||10.29|-1.57|
72396095|NCT00372112|144298439|SUPERIORITY||Mean Difference (Net)|4.6|||||TWO_SIDED|95.0|-1.45|10.65||||||Placebo versus Salmeterol 50 mcg BD for 0-4 h at Day 2.||10.65|-1.45|
72396096|NCT00372112|144298439|SUPERIORITY||Mean Difference (Net)|-4.25|||||TWO_SIDED|95.0|-10.44|1.93||||||Placebo versus GW642444 100 mcg once daily for 0-4 h at Day 7.||1.93|-10.44|
72396097|NCT00372112|144298439|SUPERIORITY||Mean Difference (Net)|-0.45|||||TWO_SIDED|95.0|-7.22|6.32||||||Placebo versus GW642444 400 mcg once daily for 0-4 h at Day 7.||6.32|-7.22|
72396098|NCT00372112|144298439|SUPERIORITY||Mean Difference (Net)|-1.46|||||TWO_SIDED|95.0|-8.25|5.33||||||Placebo versus Salmeterol 50 mcg BD for 0-4 h at Day 7.||5.33|-8.25|
72471543|NCT01443403|144466728|SUPERIORITY_OR_OTHER||LS Mean Difference|0.69|STANDARD_ERROR_OF_MEAN|0.542||0.2022|TWO_SIDED|95.0|-0.37|1.76|||ANCOVA|ANCOVA model with treatment group as a term and baseline value as a covariate.||||1.76|-0.37|0.2022
72396099|NCT00372112|144298439|SUPERIORITY||Mean Difference (Net)|0.16|||||TWO_SIDED|95.0|-5.98|6.29||||||Placebo versus GW642444 100 mcg once daily for 0-4 h at Day 8.||6.29|-5.98|
72396100|NCT00372112|144298439|SUPERIORITY||Mean Difference (Net)|8.3|||||TWO_SIDED|95.0|1.52|15.08||||||Placebo versus GW642444 400 mcg once daily for 0-4 h at Day 8.||15.08|1.52|
72396101|NCT00372112|144298439|SUPERIORITY||Mean Difference (Net)|3.82|||||TWO_SIDED|95.0|-2.85|10.5||||||Placebo versus Salmeterol 50 mcg BD for 0-4 h at Day 8.||10.50|-2.85|
72396102|NCT00372112|144298439|SUPERIORITY||Mean Difference (Net)|-1.09|||||TWO_SIDED|95.0|-7.16|4.97||||||Placebo versus GW642444 100 mcg once daily for 0-4 h at Day 14.||4.97|-7.16|
72396103|NCT00372112|144298439|SUPERIORITY||Mean Difference (Net)|6.78|||||TWO_SIDED|95.0|-0.11|13.66||||||Placebo versus GW642444 400 mcg once daily for 0-4 h at Day 14.||13.66|-0.11|
72396104|NCT00372112|144298439|SUPERIORITY||Mean Difference (Net)|3.29|||||TWO_SIDED|95.0|-3.58|10.15||||||Placebo versus Salmeterol 50 mcg BD for 0-4 h at Day 14.||10.15|-3.58|
72396105|NCT00372112|144298439|SUPERIORITY||Mean Difference (Net)|-1.12|||||TWO_SIDED|95.0|-7.64|5.4||||||Placebo versus GW642444 100 mcg once daily for 0-4 h at Day 15.||5.40|-7.64|
72396106|NCT00372112|144298439|SUPERIORITY||Mean Difference (Net)|3.59|||||TWO_SIDED|95.0|-3.71|10.89||||||Placebo versus GW642444 400 mcg once daily for 0-4 h at Day 15.||10.89|-3.71|
72471544|NCT01443403|144466731|SUPERIORITY_OR_OTHER|||||||0.0272||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0272
72396107|NCT00372112|144298439|SUPERIORITY||Mean Difference (Net)|2.11|||||TWO_SIDED|95.0|-4.96|9.18||||||Placebo versus Salmeterol 50 mcg BD for 0-4 h at Day 15.||9.18|-4.96|
72396108|NCT00372112|144298441|SUPERIORITY||Mean Difference (Net)|2.1|||||TWO_SIDED|95.0|-7.7|12.0||||||Placebo versus GW642444 100 mcg once daily for 0-4 h maximum HR at Day 1.||12.0|-7.7|
72396109|NCT00372112|144298441|SUPERIORITY||Mean Difference (Net)|3.0|||||TWO_SIDED|95.0|-7.2|13.1||||||Placebo versus GW642444 400 mcg once daily for 0-4 h maximum HR at Day 1.||13.1|-7.2|
72396110|NCT00372112|144298441|SUPERIORITY||Mean Difference (Net)|0.0|||||TWO_SIDED|95.0|-10.2|10.1||||||Placebo versus Salmeterol 50 mcg BD for 0-4 h maximum HR at Day 1.||10.1|-10.2|
72505930|NCT02544984|144543315|SUPERIORITY|||||||0.473|||||||negative binomial model|negative binomial model adjusting for use of Synagis and tracheostomy||The numbers of unscheduled clinic visits due to respiratory symptoms are compared.||||0.473
72505931|NCT02544984|144543315|SUPERIORITY|||||||0.505|||||||negative binomial model|negative binomial model adjusting for use of Synagis and tracheostomy||Unscheduled clinic visits due to symptoms other than respiratory symptoms are compared||||0.505
72505932|NCT02544984|144543315|SUPERIORITY|||||||0.047|||||||negative binomial model|negative binomial model adjusting for use of Synagis and tracheostomy||Numbers of emergency room visits are compared||||0.047
72396111|NCT00372112|144298441|SUPERIORITY||Mean Difference (Net)|2.2|||||TWO_SIDED|95.0|-6.1|10.4||||||Placebo versus GW642444 100 mcg once daily for 0-4 h maximum HR at Day 2.||10.4|-6.1|
72396112|NCT00372112|144298441|SUPERIORITY||Mean Difference (Net)|5.8|||||TWO_SIDED|95.0|-2.8|14.3||||||Placebo versus GW642444 400 mcg once daily for 0-4 h maximum HR at Day 2.||14.3|-2.8|
72396113|NCT00372112|144298441|SUPERIORITY||Mean Difference (Net)|1.6|||||TWO_SIDED|95.0|-6.9|10.1||||||Placebo versus Salmeterol 50 mcg BD for 0-4 h maximum HR at Day 2.||10.1|-6.9|
72396114|NCT00372112|144298441|SUPERIORITY||Mean Difference (Net)|-4.9|||||TWO_SIDED|95.0|-16.1|6.2||||||Placebo versus GW642444 100 mcg once daily for 0-4 h maximum HR at Day 7.||6.2|-16.1|
72396115|NCT00372112|144298441|SUPERIORITY||Mean Difference (Net)|-1.9|||||TWO_SIDED|95.0|-14.0|10.2||||||Placebo versus GW642444 400 mcg once daily for 0-4 h maximum HR at Day 7.||10.2|-14.0|
72471545|NCT01443403|144466731|SUPERIORITY_OR_OTHER|||||||0.1355||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.1355
72471546|NCT01443403|144466731|SUPERIORITY_OR_OTHER|||||||0.3689||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.3689
72396116|NCT00372112|144298441|SUPERIORITY||Mean Difference (Net)|-4.8|||||TWO_SIDED|95.0|-17.1|7.5||||||Placebo versus Salmeterol 50 mcg BD for 0-4 h maximum HR at Day 7.||7.5|-17.1|
72396117|NCT00372112|144298441|SUPERIORITY||Mean Difference (Net)|3.4|||||TWO_SIDED|95.0|-4.1|10.9||||||Placebo versus GW642444 100 mcg once daily for 0-4 h maximum HR at Day 8.||10.9|-4.1|
72396118|NCT00372112|144298441|SUPERIORITY||Mean Difference (Net)|10.8|||||TWO_SIDED|95.0|2.6|19.0||||||Placebo versus GW642444 400 mcg once daily for 0-4 h maximum HR at Day 8.||19.0|2.6|
72396119|NCT00372112|144298441|SUPERIORITY||Mean Difference (Net)|3.1|||||TWO_SIDED|95.0|-5.2|11.4||||||Placebo versus Salmeterol 50 mcg BD for 0-4 h maximum HR at Day 8.||11.4|-5.2|
72396120|NCT00372112|144298441|SUPERIORITY||Mean Difference (Net)|-7.2|||||TWO_SIDED|95.0|-17.0|2.7||||||Placebo versus GW642444 100 mcg once daily for 0-4 h maximum HR at Day 14.||2.7|-17.0|
72396121|NCT00372112|144298441|SUPERIORITY||Mean Difference (Net)|5.4|||||TWO_SIDED|95.0|-6.0|16.8||||||Placebo versus GW642444 400 mcg once daily for 0-4 h maximum HR at Day 14.||16.8|-6.0|
72396122|NCT00372112|144298441|SUPERIORITY||Mean Difference (Net)|-2.9|||||TWO_SIDED|95.0|-13.8|8.0||||||Placebo versus Salmeterol 50 mcg BD for 0-4 h maximum HR at Day 14.||8.0|-13.8|
72396123|NCT00372112|144298441|SUPERIORITY||Mean Difference (Net)|0.2|||||TWO_SIDED|95.0|-7.8|8.3||||||Placebo versus GW642444 100 mcg once daily for 0-4 h maximum HR at Day 15.||8.3|-7.8|
72396124|NCT00372112|144298441|SUPERIORITY||Mean Difference (Net)|6.8|||||TWO_SIDED|95.0|-2.1|15.6||||||Placebo versus GW642444 400 mcg once daily for 0-4 h maximum HR at Day 15.||15.6|-2.1|
72471547|NCT01443403|144466733|SUPERIORITY_OR_OTHER|||||||0.2126||95.0|||||Welch's t-test|||||||0.2126
72471548|NCT01443403|144466733|SUPERIORITY_OR_OTHER|||||||0.2799||95.0|||||Welch's t-test|||||||0.2799
72471549|NCT01443403|144466733|SUPERIORITY_OR_OTHER|||||||0.6466||95.0|||||Welch's t-test|||||||0.6466
72471550|NCT01443403|144466735|SUPERIORITY_OR_OTHER|||||||0.9826||95.0|||||Welch's t-test|||||||0.9826
72471551|NCT01443403|144466735|SUPERIORITY_OR_OTHER|||||||0.5188||95.0|||||Welch's t-test|||||||0.5188
72505933|NCT02544984|144543315|SUPERIORITY|||||||0.675|||||||negative binomial model|negative binomial model adjusting for use of Synagis and tracheostomy||Numbers of hospital admissions are compared||||0.675
72505934|NCT02544984|144543316|SUPERIORITY|||||||0.435|||||||negative binomial model|negative binomial model adjusting for use of Synagis and tracheostomy||||||0.435
72505935|NCT01214434|144543321|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||Chi-squared|||||||>0.05
72505936|NCT01214434|144543323|SUPERIORITY_OR_OTHER||||||=|0.03||95.0|||||t-test, 2 sided|||||||=0.03
72396125|NCT00372112|144298441|SUPERIORITY||Mean Difference (Net)|4.4|||||TWO_SIDED|95.0|-4.5|13.3||||||Placebo versus Salmeterol 50 mcg BD for 0-4 h maximum HR at Day 15.||13.3|-4.5|
72396126|NCT00372112|144298456|SUPERIORITY||Mean Difference (Net)|0.1131|||||TWO_SIDED|95.0|-0.0031|0.2293|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline FEV1, gender, age and treatment.||Placebo versus GW642444 100 mcg once daily for FEV1 over 22-24 h at Day 1.||0.2293|-0.0031|
72396127|NCT00372112|144298456|SUPERIORITY||Mean Difference (Net)|0.159|||||TWO_SIDED|95.0|0.0408|0.2771|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline FEV1, gender, age and treatment.||Placebo versus GW642444 400 mcg once daily for FEV1 over 22-24 h at Day 1.||0.2771|0.0408|
72396128|NCT00372112|144298456|SUPERIORITY||Mean Difference (Net)|0.0764|||||TWO_SIDED|95.0|-0.0375|0.1903|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline FEV1, gender, age and treatment.||Placebo versus Salmeterol 50 mcg BD for FEV1 over 22-24 h at Day 1.||0.1903|-0.0375|
72396129|NCT00372112|144298456|SUPERIORITY||Mean Difference (Net)|0.1741|||||TWO_SIDED|95.0|0.0178|0.3305|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline FEV1, gender, age and treatment.||Placebo versus GW642444 100 mcg once daily for FEV1 over 22-24 h at Day 7.||0.3305|0.0178|
72396130|NCT00372112|144298456|SUPERIORITY||Mean Difference (Net)|0.1713|||||TWO_SIDED|95.0|0.006|0.3365|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline FEV1, gender, age and treatment.||Placebo versus GW642444 400 mcg once daily for FEV1 over 22-24 h at Day 7.||0.3365|0.0060|
72396131|NCT00372112|144298456|SUPERIORITY||Mean Difference (Net)|0.1377|||||TWO_SIDED|95.0|-0.0233|0.2987|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline FEV1, gender, age and treatment.||Placebo versus Salmeterol 50 mcg BD for FEV1 over 22-24 h at Day 7.||0.2987|-0.0233|
72396132|NCT00372112|144298456|SUPERIORITY||Mean Difference (Net)|0.139|||||TWO_SIDED|95.0|-0.0266|0.3046|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline FEV1, gender, age and treatment.||Placebo versus GW642444 100 mcg once daily for FEV1 over 22-24 h at Day 14.||0.3046|-0.0266|
72396133|NCT00372112|144298456|SUPERIORITY||Mean Difference (Net)|0.1906|||||TWO_SIDED|95.0|0.0177|0.3635|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline FEV1, gender, age and treatment.||Placebo versus GW642444 400 mcg once daily for FEV1 over 22-24 h at Day 14.||0.3635|0.0177|
72505937|NCT01214434|144543324|SUPERIORITY_OR_OTHER||||||=|0.6||95.0|||||t-test, 2 sided|||||||=0.6
72396134|NCT00372112|144298456|SUPERIORITY||Mean Difference (Net)|0.0956|||||TWO_SIDED|95.0|-0.0686|0.2599|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline FEV1, gender, age and treatment.||Placebo versus Salmeterol 50 mcg BD for FEV1 over 22-24 h at Day 14.||0.2599|-0.0686|
72396135|NCT00372112|144298461|SUPERIORITY||Mean Difference (Net)|0.009|||||TWO_SIDED|95.0|-0.59|0.608|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline glucose, gender, age and treatment.||Placebo versus GW642444 100 mcg once daily for weighted mean glucose 0-4 h at Day 1.||0.608|-0.590|
72396136|NCT00372112|144298461|SUPERIORITY||Mean Difference (Net)|0.237|||||TWO_SIDED|95.0|-0.354|0.829|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline glucose, gender, age and treatment.||Placebo versus GW642444 400 mcg once daily for weighted mean glucose 0-4 h at Day 1.||0.829|-0.354|
72396137|NCT00372112|144298461|SUPERIORITY||Mean Difference (Net)|0.093|||||TWO_SIDED|95.0|-0.469|0.654|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline glucose, gender, age and treatment.||Placebo versus Salmeterol 50 mcg BD for weighted mean glucose 0-4 h at Day 1.||0.654|-0.469|
72396138|NCT00372112|144298461|SUPERIORITY||Mean Difference (Net)|0.199|||||TWO_SIDED|95.0|-0.591|0.988|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline glucose, gender, age and treatment.||Placebo versus GW642444 100 mcg once daily for weighted mean glucose 0-4 h at Day 2.||0.988|-0.591|
72396139|NCT00372112|144298461|SUPERIORITY||Mean Difference (Net)|0.633|||||TWO_SIDED|95.0|-0.152|1.418|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline glucose, gender, age and treatment.||Placebo versus GW642444 400 mcg once daily for weighted mean glucose 0-4 h at Day 2.||1.418|-0.152|
72396140|NCT00372112|144298461|SUPERIORITY||Mean Difference (Net)|0.065|||||TWO_SIDED|95.0|-0.667|0.797|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline glucose, gender, age and treatment.||Placebo versus Salmeterol 50 mcg BD for weighted mean glucose 0-4 h at Day 2.||0.797|-0.667|
72396141|NCT00372112|144298461|SUPERIORITY||Mean Difference (Net)|0.097|||||TWO_SIDED|95.0|-0.476|0.67|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline glucose, gender, age and treatment.||Placebo versus GW642444 100 mcg once daily for weighted mean glucose 0-4 h at Day 7.||0.670|-0.476|
72505938|NCT01214434|144543325|SUPERIORITY_OR_OTHER||||||=|0.24||95.0|||||t-test, 2 sided|||||||=.24
72396142|NCT00372112|144298461|SUPERIORITY||Mean Difference (Net)|0.408|||||TWO_SIDED|95.0|-0.208|1.024|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline glucose, gender, age and treatment.||Placebo versus GW642444 400 mcg once daily for weighted mean glucose 0-4 h at Day 7.||1.024|-0.208|
72396143|NCT00372112|144298461|SUPERIORITY||Mean Difference (Net)|0.08|||||TWO_SIDED|95.0|-0.471|0.631|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline glucose, gender, age and treatment.||Placebo versus Salmeterol 50 mcg BD for weighted mean glucose 0-4 h at Day 7.||0.631|-0.471|
72396144|NCT00372112|144298461|SUPERIORITY||Mean Difference (Net)|0.245|||||TWO_SIDED|95.0|-0.66|1.149|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline glucose, gender, age and treatment.||Placebo versus GW642444 100 mcg once daily for weighted mean glucose 0-4 h at Day 8.||1.149|-0.660|
72396145|NCT00372112|144298461|SUPERIORITY||Mean Difference (Net)|0.796|||||TWO_SIDED|95.0|-0.174|1.766|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline glucose, gender, age and treatment.||Placebo versus GW642444 400 mcg once daily for weighted mean glucose 0-4 h at Day 8.||1.766|-0.174|
72471552|NCT01443403|144466735|SUPERIORITY_OR_OTHER|||||||0.5029||95.0|||||Welch's t-test|||||||0.5029
72471553|NCT00474526|144466745|SUPERIORITY_OR_OTHER||Ratio of GMTs|4.53|||||TWO_SIDED|95.0|3.04|6.74|||ANOVA||A (Post-vaccination GMT; group ratio US1A:US2)|Using the MenACWY GMTs, immunogenicity of the fourth dose at 1 month after the 12-month vaccination in those subjects receiving MenACWY at 2, 4, and 6 months was considered superior to the immune response of a single dose given at 12-months of age if the lower limit of the two-sided 95% CI of the ratio of the two GMTs was \>= 2.0.||6.74|3.04|
72396146|NCT00372112|144298461|SUPERIORITY||Mean Difference (Net)|0.144|||||TWO_SIDED|95.0|-0.742|1.03|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline glucose, gender, age and treatment.||Placebo versus Salmeterol 50 mcg BD for weighted mean glucose 0-4 h at Day 8.||1.030|-0.742|
72396147|NCT00372112|144298461|SUPERIORITY||Mean Difference (Net)|0.056|||||TWO_SIDED|95.0|-0.556|0.669|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline glucose, gender, age and treatment.||Placebo versus GW642444 100 mcg once daily for weighted mean glucose 0-4 h at Day 14.||0.669|-0.556|
72396148|NCT00372112|144298461|SUPERIORITY||Mean Difference (Net)|-0.138|||||TWO_SIDED|95.0|-0.767|0.491|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline glucose, gender, age and treatment.||Placebo versus GW642444 400 mcg once daily for weighted mean glucose 0-4 h at Day 14.||0.491|-0.767|
72396149|NCT00372112|144298461|SUPERIORITY||Mean Difference (Net)|-0.187|||||TWO_SIDED|95.0|-0.765|0.391|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline glucose, gender, age and treatment.||Placebo versus Salmeterol 50 mcg BD for weighted mean glucose 0-4 h at Day 14.||0.391|-0.765|
72396150|NCT00372112|144298461|SUPERIORITY||Mean Difference (Net)|0.094|||||TWO_SIDED|95.0|-0.619|0.806|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline glucose, gender, age and treatment.||Placebo versus GW642444 100 mcg once daily for weighted mean glucose 0-4 h at Day 15.||0.806|-0.619|
72471554|NCT00474526|144466745|SUPERIORITY_OR_OTHER||Ratio of GMTs|6.39|||||TWO_SIDED|95.0|4.16|9.79|||ANOVA||C (Post-vaccination GMT; group ratio US1A:US2)|Using the MenACWY GMTs, immunogenicity of the fourth dose at 1 month after the 12-month vaccination in those subjects receiving MenACWY at 2, 4, and 6 months was considered superior to the immune response of a single dose given at 12-months of age if the lower limit of the two-sided 95% CI of the ratio of the two GMTs was \>= 2.0.||9.79|4.16|
72471555|NCT00474526|144466745|SUPERIORITY_OR_OTHER||Ratio of GMTs|37.0|||||TWO_SIDED|95.0|24.0|58.0|||ANOVA||W (Post-vaccination GMT; group ratio US1A:US2)|Using the MenACWY GMTs, immunogenicity of the fourth dose at 1 month after the 12-month vaccination in those subjects receiving MenACWY at 2, 4, and 6 months was considered superior to the immune response of a single dose given at 12-months of age if the lower limit of the two-sided 95% CI of the ratio of the two GMTs was \>= 2.0.||58|24|
72471556|NCT00474526|144466745|SUPERIORITY_OR_OTHER||Ratio of GMTs|38.0|||||TWO_SIDED|95.0|24.0|60.0|||ANOVA||Y (Post-vaccination GMT; group ratio US1A:US2)|"Using the MenACWY GMTs, immunogenicity of the fourth dose at 1 month after the 12-month vaccination in those subjects receiving MenACWY at 2, 4, and 6 months was considered superior to the immune response of a single dose given at 12-months of age if the lower limit of the two-sided 95% CI of the ratio of the two GMTs was \>= 2.0.~Ratio of GMTs"||60|24|
72471557|NCT00474526|144466754|NON_INFERIORITY_OR_EQUIVALENCE|LA1 was noninferior to LA3, if the lower limit of the two-sided 95% CI for the ratio of GMTs between the 2 dose and the 3 dose schedule (GMTLA1/GMTLA3) must be \> 0.5.|Ratio of GMT|0.73|||||TWO_SIDED|95.0|0.55|0.95|||ANOVA|||Serogroup A (Post-vaccination GMT; group ratio LA1:LA3)||0.95|0.55|
72505939|NCT01214434|144543326|SUPERIORITY_OR_OTHER||||||=|0.8||95.0|||||t-test, 2 sided|||||||=0.8
72505940|NCT03494725|144543369|SUPERIORITY|||||||0.757||||||Outcome was subjected to transformation to meet model assumptions. The threshold for statistical significance was p=0.05.|Mixed Models Analysis|Linear mixed model||The sample size was computed for a repeated measurement ANOVA with two groups and seven repeated measurements (power=0.85, α=0.05, f=0.1). The calculation resulted in a group size of 56 participants each, which was rounded up to 60 participants per treatment group to account for attrition.||||0.757
72396151|NCT00372112|144298461|SUPERIORITY||Mean Difference (Net)|0.358|||||TWO_SIDED|95.0|-0.39|1.105|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline glucose, gender, age and treatment.||Placebo versus GW642444 400 mcg once daily for weighted mean glucose 0-4 h at Day 15.||1.105|-0.390|
72471558|NCT00474526|144466754|NON_INFERIORITY_OR_EQUIVALENCE|LA1 was noninferior to LA3, if the lower limit of the two-sided 95% CI for the ratio of GMTs between the 2 dose and the 3 dose schedule (GMTLA1/GMTLA3) must be \> 0.5.|Ratio of GMTs|1.03|||||TWO_SIDED|95.0|0.81|1.31|||ANOVA|||Serogroup C (Post-vaccination GMT; group ratio LA1:LA3)||1.31|0.81|
72505941|NCT04083144|144543409|SUPERIORITY||η2|0.01||||0.98|TWO_SIDED||||||Mixed Models Analysis|||||||0.98
72505942|NCT04083144|144543410|SUPERIORITY||η2|0.16||||0.76|TWO_SIDED||||||Mixed Models Analysis|||||||0.76
72396152|NCT00372112|144298461|SUPERIORITY||Mean Difference (Net)|0.178|||||TWO_SIDED|95.0|-0.522|0.877|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline glucose, gender, age and treatment.||Placebo versus Salmeterol 50 mcg BD for weighted mean glucose 0-4 h at Day 15.||0.877|-0.522|
72396153|NCT00372112|144298461|SUPERIORITY||Mean Difference (Net)|-0.294|||||TWO_SIDED|95.0|-0.586|-0.001|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline potassium, gender, age and treatment.||Placebo versus GW642444 100 mcg once daily for weighted mean potassium 0-4 h at Day 1.||-0.001|-0.586|
72471559|NCT00474526|144466754|NON_INFERIORITY_OR_EQUIVALENCE|LA1 was noninferior to LA3, if the lower limit of the two-sided 95% CI for the ratio of GMTs between the 2 dose and the 3 dose schedule (GMTLA1/GMTLA3) must be \> 0.5.|Ratio of GMTs|1.42|||||TWO_SIDED|95.0|1.18|1.72|||ANOVA|||Serogroup W (Post-vaccination GMT; group ratio LA1:LA3)||1.72|1.18|
72471560|NCT00474526|144466754|NON_INFERIORITY_OR_EQUIVALENCE|LA1 was noninferior to LA3, if the lower limit of the two-sided 95% CI for the ratio of GMTs between the 2 dose and the 3 dose schedule (GMTLA1/GMTLA3) must be \> 0.5.|Ratio of GMTs|1.27|||||TWO_SIDED|95.0|1.02|1.58|||ANOVA|||Serogroup Y (Post-vaccination GMT; group ratio LA1:LA3)||1.58|1.02|
72471561|NCT00474526|144466757|NON_INFERIORITY_OR_EQUIVALENCE|LA1 was noninferior to LA3, if the lower limit of the two-sided 95% CI for the difference in percentage of subjects with hSBA ≥ 1:8 and ≥1:4 between the 2 dose and the 3 dose schedule (PLA1 - PLA3) must be greater than -10%.|Percentage (hSBA titers >=8) difference|-15.0|||||TWO_SIDED|95.0|-21.2|-8.5|||ANOVA|||Serogroup A (post-vaccination percentage of subjects with hSBA titer \>=8, group difference (PLA1 - PLA3))||-8.5|-21.2|
72505943|NCT04083144|144543411|SUPERIORITY||η2|0.02||||0.98|TWO_SIDED||||||Mixed Models Analysis|||||||0.98
72505944|NCT04083144|144543412|SUPERIORITY||η2|0.07||||0.24|TWO_SIDED||||||Mixed Models Analysis|||||||0.24
72505945|NCT04083144|144543413|SUPERIORITY||η2|0.17||||0.26|TWO_SIDED||||||Mixed Models Analysis|||||||0.26
72622907|NCT02796651|144775945|SUPERIORITY||LSMean difference|0.011||||0.488|TWO_SIDED|95.0|-0.02|0.042|||Mixed Models Analysis|||||0.042|-0.020|0.488
72396154|NCT00372112|144298461|SUPERIORITY||Mean Difference (Net)|-0.371|||||TWO_SIDED|95.0|-0.657|-0.085|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline potassium, gender, age and treatment.||Placebo versus GW642444 400 mcg once daily for weighted mean potassium 0-4 h at Day 1.||-0.085|-0.657|
72396155|NCT00372112|144298461|SUPERIORITY||Mean Difference (Net)|-0.153|||||TWO_SIDED|95.0|-0.44|0.133|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline potassium, gender, age and treatment.||Placebo versus Salmeterol 50 mcg BD for weighted mean potassium 0-4 h at Day 1.||0.133|-0.440|
72396156|NCT00372112|144298461|SUPERIORITY||Mean Difference (Net)|-0.216|||||TWO_SIDED|95.0|-0.679|0.247|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline potassium, gender, age and treatment.||Placebo versus GW642444 100 mcg once daily for weighted mean potassium 0-4 h at Day 2.||0.247|-0.679|
72396157|NCT00372112|144298461|SUPERIORITY||Mean Difference (Net)|-0.536|||||TWO_SIDED|95.0|-0.998|-0.074|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline potassium, gender, age and treatment.||Placebo versus GW642444 400 mcg once daily for weighted mean potassium 0-4 h at Day 2.||-0.074|-0.998|
72396158|NCT00372112|144298461|SUPERIORITY||Mean Difference (Net)|-0.018|||||TWO_SIDED|95.0|-0.452|0.416|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline potassium, gender, age and treatment.||Placebo versus Salmeterol 50 mcg BD for weighted mean potassium 0-4 h at Day 2.||0.416|-0.452|
72396159|NCT00372112|144298461|SUPERIORITY||Mean Difference (Net)|-0.486|||||TWO_SIDED|95.0|-0.878|-0.095|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline potassium, gender, age and treatment.||Placebo versus GW642444 100 mcg once daily for weighted mean potassium 0-4 h at Day 7.||-0.095|-0.878|
72396160|NCT00372112|144298461|SUPERIORITY||Mean Difference (Net)|-0.562|||||TWO_SIDED|95.0|-0.99|-0.135|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline potassium, gender, age and treatment.||Placebo versus GW642444 400 mcg once daily for weighted mean potassium 0-4 h at Day 7.||-0.135|-0.990|
72396161|NCT00372112|144298461|SUPERIORITY||Mean Difference (Net)|-0.19|||||TWO_SIDED|95.0|-0.575|0.196|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline potassium, gender, age and treatment.||Placebo versus Salmeterol 50 mcg BD for weighted mean potassium 0-4 h at Day 7.||0.196|-0.575|
72396162|NCT00372112|144298461|SUPERIORITY||Mean Difference (Net)|0.075|||||TWO_SIDED|95.0|-0.235|0.385|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline potassium, gender, age and treatment.||Placebo versus GW642444 100 mcg once daily for weighted mean potassium 0-4 h at Day 8.||0.385|-0.235|
72396163|NCT00372112|144298461|SUPERIORITY||Mean Difference (Net)|-0.275|||||TWO_SIDED|95.0|-0.623|0.073|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline potassium, gender, age and treatment.||Placebo versus GW642444 400 mcg once daily for weighted mean potassium 0-4 h at Day 8.||0.073|-0.623|
72565688|NCT02709486|144662693|SUPERIORITY||Odds Ratio (OR)|1.45||||0.1031|TWO_SIDED|95.0|0.93|2.27|||Regression, Logistic|||Week 2, \>=50%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.27|0.93|0.1031
72565689|NCT02709486|144662693|SUPERIORITY||Odds Ratio (OR)|1.34||||0.2033|TWO_SIDED|95.0|0.85|2.1|||Regression, Logistic|||Week 2, \>=50%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.10|0.85|0.2033
72622908|NCT02796651|144775945|SUPERIORITY||LSMean difference|0.06|||<|0.001|TWO_SIDED|95.0|0.027|0.092|||Mixed Models Analysis|||||0.092|0.027|<0.001
72471562|NCT00474526|144466757|NON_INFERIORITY_OR_EQUIVALENCE|LA1 was noninferior to LA3, if the lower limit of the two-sided 95% CI for the difference in percentage of subjects with hSBA ≥ 1:8 and ≥1:4 between the 2 dose and the 3 dose schedule (PLA1 - PLA3) must be greater than -10%.|Percentage (hSBA titers >=8) difference|-3.0|||||TWO_SIDED|95.0|-7.0|0.3|||ANOVA|||Serogroup C (post-vaccination percentage of subjects with hSBA titer \>=8, group difference (PLA1 - PLA3))||0.3|-7|
72471563|NCT00474526|144466757|NON_INFERIORITY_OR_EQUIVALENCE|LA1 was noninferior to LA3, if the lower limit of the two-sided 95% CI for the difference in percentage of subjects with hSBA ≥ 1:8 and ≥1:4 between the 2 dose and the 3 dose schedule (PLA1 - PLA3) must be greater than -10%.|Percentage (hSBA titers >=8) difference|1.0|||||TWO_SIDED|95.0|-1.3|3.1|||ANOVA|||Serogroup W (post-vaccination percentage of subjects with hSBA titer \>=8, group difference (PLA1 - PLA3))||3.1|-1.3|
72396164|NCT00372112|144298461|SUPERIORITY||Mean Difference (Net)|0.103|||||TWO_SIDED|95.0|-0.213|0.418|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline potassium, gender, age and treatment.||Placebo versus Salmeterol 50 mcg BD for weighted mean potassium 0-4 h at Day 8.||0.418|-0.213|
72396165|NCT00372112|144298461|SUPERIORITY||Mean Difference (Net)|-0.299|||||TWO_SIDED|95.0|-0.64|0.042|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline potassium, gender, age and treatment.||Placebo versus GW642444 100 mcg once daily for weighted mean potassium 0-4 h at Day 14.||0.042|-0.640|
72396166|NCT00372112|144298461|SUPERIORITY||Mean Difference (Net)|-0.271|||||TWO_SIDED|95.0|-0.621|0.079|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline potassium, gender, age and treatment.||Placebo versus GW642444 400 mcg once daily for weighted mean potassium 0-4 h at Day 14.||0.079|-0.621|
72396167|NCT00372112|144298461|SUPERIORITY||Mean Difference (Net)|-0.095|||||TWO_SIDED|95.0|-0.432|0.243|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline potassium, gender, age and treatment.||Placebo versus Salmeterol 50 mcg BD for weighted mean potassium 0-4 h at Day 14.||0.243|-0.432|
72565690|NCT02709486|144662693|SUPERIORITY||Odds Ratio (OR)|2.8||||0.0064|TWO_SIDED|95.0|1.34|5.86|||Regression, Logistic|||Week 2, \>=70%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||5.86|1.34|0.0064
72565691|NCT02709486|144662693|SUPERIORITY||Odds Ratio (OR)|1.44||||0.3706|TWO_SIDED|95.0|0.65|3.23|||Regression, Logistic|||Week 2, \>=70%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.23|0.65|0.3706
72622909|NCT02796651|144775945|SUPERIORITY||LSMean difference|0.02||||0.206|TWO_SIDED|95.0|-0.011|0.051|||Mixed Models Analysis|||||0.051|-0.011|0.206
72396168|NCT00372112|144298461|SUPERIORITY||Mean Difference (Net)|0.173|||||TWO_SIDED|95.0|-0.158|0.505|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline potassium, gender, age and treatment.||Placebo versus GW642444 100 mcg once daily for weighted mean potassium 0-4 h at Day 15.||0.505|-0.158|
72396169|NCT00372112|144298461|SUPERIORITY||Mean Difference (Net)|-0.196|||||TWO_SIDED|95.0|-0.535|0.143|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline potassium, gender, age and treatment.||Placebo versus GW642444 400 mcg once daily for weighted mean potassium 0-4 h at Day 15.||0.143|-0.535|
72471564|NCT00474526|144466757|NON_INFERIORITY_OR_EQUIVALENCE|LA1 was noninferior to LA3, if the lower limit of the two-sided 95% CI for the difference in percentage of subjects with hSBA ≥ 1:8 and ≥1:4 between the 2 dose and the 3 dose schedule (PLA1 - PLA3) must be greater than -10%.|Percentage (hSBA titers >=8) difference|-1.0|||||TWO_SIDED|95.0|-4.0|1.7|||ANOVA|||Serogroup Y (post-vaccination percentage of subjects with hSBA titer \>=8, group difference (PLA1 - PLA3))||1.7|-4|
72471565|NCT00474526|144466759|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the ratio of pertussis GMCs (GMCUS1 /GMCUS2) must be greater than 0.67; the lower limit of 95% CI for the ratio of all other GMCs (GMCUS1 / GMCUS2) must be greater than 0.50.|Ratio of GMTs|0.87|||||TWO_SIDED|95.0|0.74|1.04|||ANOVA|||Diphtheria (Post-vaccination GMT; group ratio US1:US2)||1.04|0.74|
72471566|NCT00474526|144466759|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the ratio of pertussis GMCs (GMCUS1 /GMCUS2) must be greater than 0.67; the lower limit of 95% CI for the ratio of all other GMCs (GMCUS1 / GMCUS2) must be greater than 0.50.|Ratio of GMTs|1.08|||||TWO_SIDED|95.0|0.92|1.28|||ANOVA|||Tetanus (Post-vaccination GMT; group ratio US1:US2)||1.28|0.92|
72471567|NCT00474526|144466759|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the ratio of pertussis GMCs (GMCUS1 /GMCUS2) must be greater than 0.67; the lower limit of 95% CI for the ratio of all other GMCs (GMCUS1 / GMCUS2) must be greater than 0.50.|Ratio of GMTs|1.0|||||TWO_SIDED|95.0|0.79|1.26|||ANOVA|||PT (Post-vaccination GMT; group ratio US1:US2)||1.26|0.79|
72471568|NCT00474526|144466759|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the ratio of pertussis GMCs (GMCUS1 /GMCUS2) must be greater than 0.67; the lower limit of 95% CI for the ratio of all other GMCs (GMCUS1 / GMCUS2) must be greater than 0.50.|Ratio of GMTs|1.03|||||TWO_SIDED|95.0|0.85|1.25||||||FHA (Post-vaccination GMT; group ratio US1:US2)||1.25|0.85|
72471569|NCT00474526|144466759|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the ratio of pertussis GMCs (GMCUS1 /GMCUS2) must be greater than 0.67; the lower limit of 95% CI for the ratio of all other GMCs (GMCUS1 / GMCUS2) must be greater than 0.50.|Ratio of GMTs|1.04|||||TWO_SIDED|95.0|0.83|1.32|||ANOVA|||Pertactin (Post-vaccination GMT; group ratio US1:US2||1.32|0.83|
72622910|NCT02796651|144775945|SUPERIORITY||LSMean difference|0.049||||0.004|TWO_SIDED|95.0|0.016|0.081|||Mixed Models Analysis|||||0.081|0.016|0.004
72471570|NCT00474526|144466759|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the ratio of pertussis GMCs (GMCUS1 /GMCUS2) must be greater than 0.67; the lower limit of 95% CI for the ratio of all other GMCs (GMCUS1 / GMCUS2) must be greater than 0.50.|Ratio of GMTs|0.96|||||TWO_SIDED|95.0|0.75|1.23|||ANOVA|||Polio Type 1 (Post-vaccination GMT; group ratio US1:US2)||1.23|0.75|
72471571|NCT00474526|144466759|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the ratio of pertussis GMCs (GMCUS1 /GMCUS2) must be greater than 0.67; the lower limit of 95% CI for the ratio of all other GMCs (GMCUS1 / GMCUS2) must be greater than 0.50.|Ratio of GMTs|1.2|||||TWO_SIDED|95.0|0.93|1.55|||ANOVA|||Polio Type 2 (Post-vaccination GMT; group ratio US1:US2)||1.55|0.93|
72471572|NCT00474526|144466759|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the ratio of pertussis GMCs (GMCUS1 /GMCUS2) must be greater than 0.67; the lower limit of 95% CI for the ratio of all other GMCs (GMCUS1 / GMCUS2) must be greater than 0.50.|Ratio of GMTs|1.15|||||TWO_SIDED|95.0|0.85|1.56|||ANOVA|||Polio Type 3 (Post-vaccination GMT; group ratio US1:US2)||1.56|0.85|
72471573|NCT00474526|144466759|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the ratio of pertussis GMCs (GMCUS1 /GMCUS2) must be greater than 0.67; the lower limit of 95% CI for the ratio of all other GMCs (GMCUS1 / GMCUS2) must be greater than 0.50.|Ratio of GMTs|0.88||||||95.0|0.65|1.2|||ANOVA|||Hepatitis B (Post-vaccination GMT; group ratio US1:US2)||1.2|0.65|
72471574|NCT00474526|144466759|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the ratio of pertussis GMCs (GMCUS1 /GMCUS2) must be greater than 0.67; the lower limit of 95% CI for the ratio of all other GMCs (GMCUS1 / GMCUS2) must be greater than 0.50.|Ratio of GMTs|1.31|||||TWO_SIDED|95.0|0.97|1.77|||ANOVA|||HIb (Post-vaccination GMT; group ratio US1:US2)||1.77|0.97|
72471575|NCT00474526|144466759|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the ratio of pertussis GMCs (GMCUS1 /GMCUS2) must be greater than 0.67; the lower limit of 95% CI for the ratio of all other GMCs (GMCUS1 / GMCUS2) must be greater than 0.50.|Ratio of GMTs|0.84|||||TWO_SIDED|95.0|0.7|1.0|||ANOVA|||PnC 4 (Post-vaccination GMT; group ratio US1:US2)||1|0.7|
72471576|NCT00474526|144466759|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the ratio of pertussis GMCs (GMCUS1 /GMCUS2) must be greater than 0.67; the lower limit of 95% CI for the ratio of all other GMCs (GMCUS1 / GMCUS2) must be greater than 0.50.|Ratio of GMTs|0.76|||||TWO_SIDED|95.0|0.56|1.03|||ANOVA|||PnC 6B (Post-vaccination GMT; group ratio US1:US2)||1.03|0.56|
72622911|NCT02796651|144775945|SUPERIORITY||LSMean difference|0.009||||0.567|TWO_SIDED|95.0|-0.022|0.041|||Mixed Models Analysis|||||0.041|-0.022|0.567
72622912|NCT02796651|144775945|SUPERIORITY||LSMean difference|-0.039||||0.017|TWO_SIDED|95.0|-0.072|-0.007|||Mixed Models Analysis|||||-0.007|-0.072|0.017
72622913|NCT02796651|144775946|SUPERIORITY||LSMean difference|0.075||||0.027|TWO_SIDED|95.0|0.008|0.141|||Mixed Models Analysis|||||0.141|0.008|0.027
72396170|NCT00372112|144298461|SUPERIORITY||Mean Difference (Net)|0.139|||||TWO_SIDED|95.0|-0.198|0.475|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline potassium, gender, age and treatment.||Placebo versus Salmeterol 50 mcg BD for weighted mean potassium 0-4 h at Day 15.||0.475|-0.198|
72396171|NCT00372112|144298461|SUPERIORITY||Mean Difference (Net)|-0.14|||||TWO_SIDED|95.0|-1.18|0.9|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline glucose, gender, age and treatment.||Placebo versus GW642444 100 mcg once daily for maximum glucose 0-4 h at Day 1.||0.90|-1.18|
72396172|NCT00372112|144298461|SUPERIORITY||Mean Difference (Net)|0.29|||||TWO_SIDED|95.0|-0.72|1.3|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline glucose, gender, age and treatment.||Placebo versus GW642444 400 mcg once daily for maximum glucose 0-4 h at Day 1.||1.30|-0.72|
72396173|NCT00372112|144298461|SUPERIORITY||Mean Difference (Net)|-0.17|||||TWO_SIDED|95.0|-1.15|0.8|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline glucose, gender, age and treatment.||Placebo versus Salmeterol 50 mcg BD for maximum glucose 0-4 h at Day 1.||0.80|-1.15|
72396174|NCT00372112|144298461|SUPERIORITY||Mean Difference (Net)|0.4|||||TWO_SIDED|95.0|-0.64|1.44|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline glucose, gender, age and treatment.||Placebo versus GW642444 100 mcg once daily for maximum glucose 0-4 h at Day 2.||1.44|-0.64|
72396175|NCT00372112|144298461|SUPERIORITY||Mean Difference (Net)|0.69|||||TWO_SIDED|95.0|-0.32|1.7|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline glucose, gender, age and treatment.||Placebo versus GW642444 400 mcg once daily for maximum glucose 0-4 h at Day 2.||1.70|-0.32|
72396176|NCT00372112|144298461|SUPERIORITY||Mean Difference (Net)|0.23|||||TWO_SIDED|95.0|-0.74|1.2|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline glucose, gender, age and treatment.||Placebo versus Salmeterol 50 mcg BD for maximum glucose 0-4 h at Day 2.||1.20|-0.74|
72396177|NCT00372112|144298461|SUPERIORITY||Mean Difference (Net)|-0.05|||||TWO_SIDED|95.0|-1.11|1.01|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline glucose, gender, age and treatment.||Placebo versus GW642444 100 mcg once daily for maximum glucose 0-4 h at Day 7.||1.01|-1.11|
72396178|NCT00372112|144298461|SUPERIORITY||Mean Difference (Net)|0.53|||||TWO_SIDED|95.0|-0.57|1.62|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline glucose, gender, age and treatment.||Placebo versus GW642444 400 mcg once daily for maximum glucose 0-4 h at Day 7.||1.62|-0.57|
72396179|NCT00372112|144298461|SUPERIORITY||Mean Difference (Net)|0.13|||||TWO_SIDED|95.0|-0.89|1.15|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline glucose, gender, age and treatment.||Placebo versus Salmeterol 50 mcg BD for maximum glucose 0-4 h at Day 7.||1.15|-0.89|
72396180|NCT00372112|144298461|SUPERIORITY||Mean Difference (Net)|0.26|||||TWO_SIDED|95.0|-0.98|1.5|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline glucose, gender, age and treatment.||Placebo versus GW642444 100 mcg once daily for maximum glucose 0-4 h at Day 8.||1.50|-0.98|
72396181|NCT00372112|144298461|SUPERIORITY||Mean Difference (Net)|0.86|||||TWO_SIDED|95.0|-0.42|2.14|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline glucose, gender, age and treatment.||Placebo versus GW642444 400 mcg once daily for maximum glucose 0-4 h at Day 8.||2.14|-0.42|
72396182|NCT00372112|144298461|SUPERIORITY||Mean Difference (Net)|0.32|||||TWO_SIDED|95.0|-0.9|1.54|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline glucose, gender, age and treatment.||Placebo versus Salmeterol 50 mcg BD for maximum glucose 0-4 h at Day 8.||1.54|-0.90|
72396183|NCT00372112|144298461|SUPERIORITY||Mean Difference (Net)|0.05|||||TWO_SIDED|95.0|-1.2|1.3|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline glucose, gender, age and treatment.||Placebo versus GW642444 100 mcg once daily for maximum glucose 0-4 h at Day 14.||1.30|-1.20|
72396184|NCT00372112|144298461|SUPERIORITY||Mean Difference (Net)|0.75|||||TWO_SIDED|95.0|-0.53|2.03|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline glucose, gender, age and treatment.||Placebo versus GW642444 400 mcg once daily for maximum glucose 0-4 h at Day 14.||2.03|-0.53|
72396185|NCT00372112|144298461|SUPERIORITY||Mean Difference (Net)|0.0|||||TWO_SIDED|95.0|-1.23|1.23|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline glucose, gender, age and treatment.||Placebo versus Salmeterol 50 mcg BD for maximum glucose 0-4 h at Day 14.||1.23|-1.23|
72396186|NCT00372112|144298461|SUPERIORITY||Mean Difference (Net)|0.22|||||TWO_SIDED|95.0|-0.78|1.23|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline glucose, gender, age and treatment.||Placebo versus GW642444 100 mcg once daily for maximum glucose 0-4 h at Day 15.||1.23|-0.78|
72471577|NCT00474526|144466759|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the ratio of pertussis GMCs (GMCUS1 /GMCUS2) must be greater than 0.67; the lower limit of 95% CI for the ratio of all other GMCs (GMCUS1 / GMCUS2) must be greater than 0.50.|Ratio of GMTs|0.85||||||95.0|0.7|1.04|||ANOVA|||PnC 9V (Post-vaccination GMT; group ratio US1:US2)||1.04|0.7|
72471578|NCT00474526|144466759|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the ratio of pertussis GMCs (GMCUS1 /GMCUS2) must be greater than 0.67; the lower limit of 95% CI for the ratio of all other GMCs (GMCUS1 / GMCUS2) must be greater than 0.50.|Ratio of GMTs|1.03|||||TWO_SIDED|95.0|0.84|1.26|||ANOVA|||PnC 14 (Post-vaccination GMT; group ratio US1:US2)||1.26|0.84|
72471579|NCT00474526|144466759|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the ratio of pertussis GMCs (GMCUS1 /GMCUS2) must be greater than 0.67; the lower limit of 95% CI for the ratio of all other GMCs (GMCUS1 / GMCUS2) must be greater than 0.50.|Ratio of GMTs|0.77|||||TWO_SIDED|95.0|0.64|0.93|||ANOVA|||PnC 18C (Post-vaccination GMT; group ratio US1:US2)||0.93|0.64|
72471580|NCT00474526|144466759|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the ratio of pertussis GMCs (GMCUS1 /GMCUS2) must be greater than 0.67; the lower limit of 95% CI for the ratio of all other GMCs (GMCUS1 / GMCUS2) must be greater than 0.50.|Ratio of GMTs|0.82|||||TWO_SIDED|95.0|0.69|0.97|||ANOVA|||PnC 19F (Post-vaccination GMT; group ratio US1:US2)||0.97|0.69|
72396187|NCT00372112|144298461|SUPERIORITY||Mean Difference (Net)|0.84|||||TWO_SIDED|95.0|-0.21|1.89|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline glucose, gender, age and treatment.||Placebo versus GW642444 400 mcg once daily for maximum glucose 0-4 h at Day 15.||1.89|-0.21|
72396188|NCT00372112|144298461|SUPERIORITY||Mean Difference (Net)|0.49|||||TWO_SIDED|95.0|-0.5|1.48|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline glucose, gender, age and treatment.||Placebo versus Salmeterol 50 mcg BD for maximum glucose 0-4 h at Day 15.||1.48|-0.50|
72471581|NCT00474526|144466759|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the ratio of pertussis GMCs (GMCUS1 /GMCUS2) must be greater than 0.67; the lower limit of 95% CI for the ratio of all other GMCs (GMCUS1 / GMCUS2) must be greater than 0.50.|Ratio of GMTs|0.79|||||TWO_SIDED|95.0|0.62|1.02|||ANOVA|||PnC 23F (Post-vaccination GMT; group ratio US1:US2)||1.02|0.62|
72396189|NCT00372112|144298461|SUPERIORITY||Mean Difference (Final Values)|-0.19|||||TWO_SIDED|95.0|-0.47|0.09|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline potassium, gender, age and treatment.||Placebo versus GW642444 100 mcg once daily for minimum potassium 0-4 h at Day 1.||0.09|-0.47|
72396190|NCT00372112|144298461|SUPERIORITY||Mean Difference (Net)|-0.22|||||TWO_SIDED|95.0|-0.49|0.04|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline potassium, gender, age and treatment.||Placebo versus GW642444 400 mcg once daily for minimum potassium 0-4 h at Day 1.||0.04|-0.49|
72396191|NCT00372112|144298461|SUPERIORITY||Mean Difference (Net)|-0.19|||||TWO_SIDED|95.0|-0.46|0.07|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline potassium, gender, age and treatment.||Placebo versus Salmeterol 50 mcg BD for minimum potassium 0-4 h at Day 1.||0.07|-0.46|
72471582|NCT00474526|144466760|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the difference in seroresponse rates (PUS1 - PUS2) must be greater than -5% for polio and -10% for all others.|Seroconversion Percentage difference|0.0|||||TWO_SIDED|95.0|-3.0|3.0|||ANOVA|||Diphtheria (Seroconversion percentage difference (PUS1 - PUS2))||3|-3|
72471583|NCT00474526|144466760|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the difference in seroresponse rates (PUS1 - PUS2) must be greater than -5% for polio and -10% for all others.|Seroconversion Percentage difference|0.0|||||TWO_SIDED|95.0|-2.0|4.0|||ANOVA|||Tetanus (Seroconversion percentage difference (PUS1 - PUS2))||4|-2|
72471584|NCT00474526|144466760|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the difference in seroresponse rates (PUS1 - PUS2) must be greater than -5% for polio and -10% for all others.|Seroconversion Percentage difference|2.0|||||TWO_SIDED|95.0|-7.0|12.0|||ANOVA|||PT (Seroconversion percentage difference (PUS1 - PUS2))||12|-7|
72471585|NCT00474526|144466760|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the difference in seroresponse rates (PUS1 - PUS2) must be greater than -5% for polio and -10% for all others.|Seroconversion Percentage difference|6.0|||||TWO_SIDED|95.0|-4.0|17.0|||ANOVA|||FHA(Seroconversion percentage difference (PUS1 - PUS2))||17|-4|
72471586|NCT00474526|144466760|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the difference in seroresponse rates (PUS1 - PUS2) must be greater than -5% for polio and -10% for all others.|Seroconversion Percentage difference|-2.0|||||TWO_SIDED|95.0|-12.0|10.0|||ANOVA|||Pertactin (Seroconversion percentage difference (PUS1 - PUS2))||10|-12|
72396192|NCT00372112|144298461|SUPERIORITY||Mean Difference (Net)|-0.1|||||TWO_SIDED|95.0|-0.47|0.27|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline potassium, gender, age and treatment.||Placebo versus GW642444 100 mcg once daily for minimum potassium 0-4 h at Day 2.||0.27|-0.47|
72396193|NCT00372112|144298461|SUPERIORITY||Mean Difference (Net)|-0.38|||||TWO_SIDED|95.0|-0.73|-0.03|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline potassium, gender, age and treatment.||Placebo versus GW642444 400 mcg once daily for minimum potassium 0-4 h at Day 2.||-0.03|-0.73|
72396194|NCT00372112|144298461|SUPERIORITY||Mean Difference (Net)|-0.02|||||TWO_SIDED|95.0|-0.37|0.34|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline potassium, gender, age and treatment.||Placebo versus Salmeterol 50 mcg BD for minimum potassium 0-4 h at Day 2.||0.34|-0.37|
72471587|NCT00474526|144466760|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the difference in seroresponse rates (PUS1 - PUS2) must be greater than -5% for polio and -10% for all others.|Seroconversion Percentage difference|-1.0|||||TWO_SIDED|95.0|-3.0|3.0|||ANOVA|||Polio Type 1 (Seroconversion percentage difference (PUS1 - PUS2))||3|-3|
72471588|NCT00474526|144466760|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the difference in seroresponse rates (PUS1 - PUS2) must be greater than -5% for polio and -10% for all others.|Seroconversion Percentage difference|0.0|||||TWO_SIDED|95.0|-2.0|4.0|||ANOVA|||Polio Type 2 (Seroconversion percentage difference (PUS1 - PUS2))||4|-2|
72471589|NCT00474526|144466760|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the difference in seroresponse rates (PUS1 - PUS2) must be greater than -5% for polio and -10% for all others.|Seroconversion Percentage difference|-1.0|||||TWO_SIDED|95.0|-3.0|3.0|||ANOVA|||Polio Type 3 (Seroconversion percentage difference (PUS1 - PUS2))||3|-3|
72396195|NCT00372112|144298461|SUPERIORITY||Mean Difference (Net)|-0.54|||||TWO_SIDED|95.0|-0.97|-0.12|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline potassium, gender, age and treatment.||Placebo versus GW642444 100 mcg once daily for minimum potassium 0-4 h at Day 7.||-0.12|-0.97|
72396196|NCT00372112|144298461|SUPERIORITY||Mean Difference (Net)|-0.55|||||TWO_SIDED|95.0|-0.98|-0.12|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline potassium, gender, age and treatment.||Placebo versus GW642444 400 mcg once daily for minimum potassium 0-4 h at Day 7.||-0.12|-0.98|
72396197|NCT00372112|144298461|SUPERIORITY||Mean Difference (Net)|-0.34|||||TWO_SIDED|95.0|-0.76|0.08|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline potassium, gender, age and treatment.||Placebo versus Salmeterol 50 mcg BD for minimum potassium 0-4 h at Day 7.||0.08|-0.76|
72396198|NCT00372112|144298461|SUPERIORITY||Mean Difference (Net)|0.03|||||TWO_SIDED|95.0|-0.26|0.33|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline potassium, gender, age and treatment.||Placebo versus GW642444 100 mcg once daily for minimum potassium 0-4 h at Day 8.||0.33|-0.26|
72396199|NCT00372112|144298461|SUPERIORITY||Mean Difference (Net)|-0.4|||||TWO_SIDED|95.0|-0.7|-0.1|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline potassium, gender, age and treatment.||Placebo versus GW642444 400 mcg once daily for minimum potassium 0-4 h at Day 8.||-0.10|-0.70|
72396200|NCT00372112|144298461|SUPERIORITY||Mean Difference (Net)|0.04|||||TWO_SIDED|95.0|-0.26|0.34|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline potassium, gender, age and treatment.||Placebo versus Salmeterol 50 mcg BD for minimum potassium 0-4 h at Day 8.||0.34|-0.26|
72471590|NCT00474526|144466760|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the difference in seroresponse rates (PUS1 - PUS2) must be greater than -5% for polio and -10% for all others.|Seroconversion Percentage difference|-1.0|||||TWO_SIDED|95.0|-4.0|3.0|||ANOVA|||Hepatitis B(Seroconversion percentage difference (PUS1 - PUS2))||3|-4|
72622914|NCT02796651|144775946|SUPERIORITY||LSMean difference|0.065||||0.054|TWO_SIDED|95.0|-0.001|0.131|||Mixed Models Analysis|||||0.131|-0.001|0.054
72396201|NCT00372112|144298461|SUPERIORITY||Mean Difference (Net)|-0.15|||||TWO_SIDED|95.0|-0.42|0.12|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline potassium, gender, age and treatment.||Placebo versus GW642444 100 mcg once daily for minimum potassium 0-4 h at Day 14.||0.12|-0.42|
72396202|NCT00372112|144298461|SUPERIORITY||Mean Difference (Net)|-0.23|||||TWO_SIDED|95.0|-0.51|0.04|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline potassium, gender, age and treatment.||Placebo versus GW642444 400 mcg once daily for minimum potassium 0-4 h at Day 14.||0.04|-0.51|
72471591|NCT00474526|144466760|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the difference in seroresponse rates (PUS1 - PUS2) must be greater than -5% for polio and -10% for all others.|Seroconversion Percentage difference|-1.0|||||TWO_SIDED|95.0|-3.0|3.0|||ANOVA|||Hib (≥ 0.15 μg/mL)(Seroconversion percentage difference (PUS1 - PUS2))||3|-3|
72471592|NCT00474526|144466760|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the difference in seroresponse rates (PUS1 - PUS2) must be greater than -5% for polio and -10% for all others.|Seroconversion Percentage difference|5.0|||||TWO_SIDED|95.0|-3.0|14.0|||ANOVA|||Hib (≥1.0 μg/mL)(Seroconversion percentage difference (PUS1 - PUS2))||14|-3|
72505946|NCT02760407|144543418|SUPERIORITY||Risk Difference (RD)|0.27|||<|0.0001|TWO_SIDED|97.5|0.183|0.352|||Chi-squared|2x2 chi-square test||The OKZ ACR20 response rate for the 64 mg q4w treatment group at Week 12 was expected to be at least 50% resulting in an expected difference in ACR20 response rates of 25 percentage points between the respective OKZ treatment group and placebo. Sample size yield 100% disjunctive power for testing the primary hypothesis||0.352|0.183|<0.0001
72471593|NCT00474526|144466760|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the difference in seroresponse rates (PUS1 - PUS2) must be greater than -5% for polio and -10% for all others.|Seroconversion Percentage difference|-2.0|||||TWO_SIDED|95.0|-5.0|2.0|||ANOVA|||PnC 4(Seroconversion percentage difference (PUS1 - PUS2))||2|-5|
72471594|NCT00474526|144466760|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the difference in seroresponse rates (PUS1 - PUS2) must be greater than -5% for polio and -10% for all others.|(Seroconversion percentage difference (P|-8.0|||||TWO_SIDED|95.0|-14.0|-1.0|||ANOVA|||PnC 6B(Seroconversion percentage difference (PUS1 - PUS2))||-1|-14|
72471595|NCT00474526|144466760|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the difference in seroresponse rates (PUS1 - PUS2) must be greater than -5% for polio and -10% for all others.|Seroconversion Percentage difference|0.0|||||TWO_SIDED|95.0|-4.0|5.0|||ANOVA|||PnC 9V (Seroconversion percentage difference (PUS1 - PUS2))||5|-4|
72471596|NCT00474526|144466760|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the difference in seroresponse rates (PUS1 - PUS2) must be greater than -5% for polio and -10% for all others.|Diphtheria (Seroconversion percentage di|1.0|||||TWO_SIDED|95.0|-1.0|5.0|||ANOVA|||PnC 14 (Seroconversion percentage difference (PUS1 - PUS2))||5|-1|
72471597|NCT00474526|144466760|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the difference in seroresponse rates (PUS1 - PUS2) must be greater than -5% for polio and -10% for all others.|Seroconversion Percentage difference|-3.0|||||TWO_SIDED|95.0|-6.0|1.0|||ANOVA|||PnC 18C (Seroconversion percentage difference (PUS1 - PUS2))||1|-6|
72471598|NCT00474526|144466760|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the difference in seroresponse rates (PUS1 - PUS2) must be greater than -5% for polio and -10% for all others.|(Seroconversion percentage difference (P|-1.0|||||TWO_SIDED|95.0|-4.0|3.0|||ANOVA|||PnC 19F (Seroconversion percentage difference (PUS1 - PUS2))||3|-4|
72471599|NCT00474526|144466760|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the difference in seroresponse rates (PUS1 - PUS2) must be greater than -5% for polio and -10% for all others.|Seroconversion Percentage difference|-2.0|||||TWO_SIDED|95.0|-8.0|5.0|||ANOVA|||PnC 23F (Seroconversion percentage difference (PUS1 - PUS2))||5|-8|
72471600|NCT00474526|144466761|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the ratio of pertussis GMCs (GMCLA1 / GMCLA2) must be greater than 0.67; the lower limit of the 95% CI for the ratio of all other GMCs (GMCLA1 / GMCLA2) must be greater than 0.50.|Ratio of GMCs|1.16|||||TWO_SIDED|95.0|0.96|1.4|||ANOVA|||Diphtheria (Post-vaccination GMC; group ratio LA1:LA2)||1.4|0.96|
72505947|NCT02760407|144543418|SUPERIORITY||Risk Difference (RD)|0.258|||<|0.0001|TWO_SIDED|97.5|0.171|0.341|||Chi-squared|2x2 chi-square test||The OKZ ACR20 response rate for the 64 mg q2w treatment group at Week 12 was expected to be at least 55%, resulting in an expected difference in ACR20 response rate of 30 percentage points between the respective OKZ treatment group and placebo. Sample size yield 100% disjunctive power for testing the primary hypothesis||0.341|0.171|<0.0001
72505948|NCT02760407|144543419|SUPERIORITY||Risk Difference (RD)|0.224|||<|0.0001|TWO_SIDED|95.0|0.148|0.298|||Chi-squared|2x2 chi-square test||The ACR20 response rate for adalimumab was expected to be at least 52.5% at Week 12.||0.298|0.148|<0.0001
72396203|NCT00372112|144298461|SUPERIORITY||Mean Difference (Net)|-0.06|||||TWO_SIDED|95.0|-0.34|0.21|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline potassium, gender, age and treatment.||Placebo versus Salmeterol 50 mcg BD for minimum potassium 0-4 h at Day 14.||0.21|-0.34|
72471601|NCT00474526|144466761|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the ratio of pertussis GMCs (GMCLA1 / GMCLA2) must be greater than 0.67; the lower limit of the 95% CI for the ratio of all other GMCs (GMCLA1 / GMCLA2) must be greater than 0.50.|Ratio of GMCs|1.1|||||TWO_SIDED|95.0|0.96|1.27|||ANOVA|||Tetanus (Post-vaccination GMC; group ratio LA1:LA2)||1.27|0.96|
72471602|NCT00474526|144466761|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the ratio of pertussis GMCs (GMCLA1 / GMCLA2) must be greater than 0.67; the lower limit of the 95% CI for the ratio of all other GMCs (GMCLA1 / GMCLA2) must be greater than 0.50.|Ratio of GMCs|1.04|||||TWO_SIDED|95.0|0.87|1.25|||ANOVA|||PT (Post-vaccination GMC; group ratio LA1:LA2)||1.25|0.87|
72471603|NCT00474526|144466761|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the ratio of pertussis GMCs (GMCLA1 / GMCLA2) must be greater than 0.67; the lower limit of the 95% CI for the ratio of all other GMCs (GMCLA1 / GMCLA2) must be greater than 0.50.|Ratio of GMCs|1.05|||||TWO_SIDED|95.0|0.89|1.23|||ANOVA|||FHA (Post-vaccination GMC; group ratio LA1:LA2)||1.23|0.89|
72471604|NCT00474526|144466761|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the ratio of pertussis GMCs (GMCLA1 / GMCLA2) must be greater than 0.67; the lower limit of the 95% CI for the ratio of all other GMCs (GMCLA1 / GMCLA2) must be greater than 0.50.|Ratio of GMCs|0.99|||||TWO_SIDED|95.0|0.81|1.21|||ANOVA|||Pertactin (Post-vaccination GMC; group ratio LA1:LA2)||1.21|0.81|
72471605|NCT00474526|144466761|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the ratio of pertussis GMCs (GMCLA1 / GMCLA2) must be greater than 0.67; the lower limit of the 95% CI for the ratio of all other GMCs (GMCLA1 / GMCLA2) must be greater than 0.50.|Ratio of GMTs|0.9|||||TWO_SIDED|95.0|0.68|1.17|||ANOVA|||Polio Type 1 (Post-vaccination GMT; group ratio LA1:LA2)||1.17|0.68|
72471606|NCT00474526|144466761|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the ratio of pertussis GMCs (GMCLA1 / GMCLA2) must be greater than 0.67; the lower limit of the 95% CI for the ratio of all other GMCs (GMCLA1 / GMCLA2) must be greater than 0.50.|Ratio of GMTs|0.97|||||TWO_SIDED|95.0|0.73|1.28|||ANOVA|||Polio Type 2 (Post-vaccination GMT; group ratio LA1:LA2)||1.28|0.73|
72471607|NCT00474526|144466761|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the ratio of pertussis GMCs (GMCLA1 / GMCLA2) must be greater than 0.67; the lower limit of the 95% CI for the ratio of all other GMCs (GMCLA1 / GMCLA2) must be greater than 0.50.|Ratio of GMTs|0.95||||||95.0|0.69|1.31|||ANOVA|||Polio Type 3 (Post-vaccination GMT; group ratio LA1:LA2)||1.31|0.69|
72471608|NCT00474526|144466761|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the ratio of pertussis GMCs (GMCLA1 / GMCLA2) must be greater than 0.67; the lower limit of the 95% CI for the ratio of all other GMCs (GMCLA1 / GMCLA2) must be greater than 0.50.|Ratio of GMCs|1.11|||||TWO_SIDED|95.0|0.88|1.4|||ANOVA|||Hepatitis B (Post-vaccination GMC; group ratio LA1:LA2)||1.4|0.88|
72471609|NCT00474526|144466761|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the ratio of pertussis GMCs (GMCLA1 / GMCLA2) must be greater than 0.67; the lower limit of the 95% CI for the ratio of all other GMCs (GMCLA1 / GMCLA2) must be greater than 0.50.|Ratio of GMCs|1.27|||||TWO_SIDED|95.0|0.98|1.65|||ANOVA|||HIb (Post-vaccination GMC; group ratio LA1:LA2)||1.65|0.98|
72471610|NCT00474526|144466761|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the ratio of pertussis GMCs (GMCLA1 / GMCLA2) must be greater than 0.67; the lower limit of the 95% CI for the ratio of all other GMCs (GMCLA1 / GMCLA2) must be greater than 0.50.|Ratio of GMCs|0.92|||||TWO_SIDED|95.0|0.78|1.09|||ANOVA|||PnC 4 (Post-vaccination GMC; group ratio LA1:LA2)||1.09|0.78|
72505949|NCT02760407|144543419|NON_INFERIORITY|Non-Inferiority for each OKZ dosing regimen versus Adalimumab is achieved if the lower limit of the 97.5% confidence interval is greater than the protocol defined non-inferiority margin of -12%.|Risk Difference (RD)|0.045|||||TWO_SIDED|97.5|-0.022|0.112||||||A noninferiority margin of 12% was used for the comparison between OKZ and adalimumab with respect to this endpoint.||0.112|-0.022|
72471611|NCT00474526|144466761|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the ratio of pertussis GMCs (GMCLA1 / GMCLA2) must be greater than 0.67; the lower limit of the 95% CI for the ratio of all other GMCs (GMCLA1 / GMCLA2) must be greater than 0.50.|Ratio of GMCs|0.97|||||TWO_SIDED|95.0|0.74|1.27|||ANOVA|||PnC 6B (Post-vaccination GMC; group ratio LA1:LA2)||1.27|0.74|
72471612|NCT00474526|144466761|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the ratio of pertussis GMCs (GMCLA1 / GMCLA2) must be greater than 0.67; the lower limit of the 95% CI for the ratio of all other GMCs (GMCLA1 / GMCLA2) must be greater than 0.50.|Ratio of GMCs|0.86|||||TWO_SIDED|95.0|0.71|1.04|||ANOVA|||PnC 9V (Post-vaccination GMC; group ratio LA1:LA2)||1.04|0.71|
72471613|NCT00474526|144466761|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the ratio of pertussis GMCs (GMCLA1 / GMCLA2) must be greater than 0.67; the lower limit of the 95% CI for the ratio of all other GMCs (GMCLA1 / GMCLA2) must be greater than 0.50.|Ratio of GMCs|0.91|||||TWO_SIDED|95.0|0.72|1.14|||ANOVA|||PnC 14 (Post-vaccination GMC; group ratio LA1:LA2)||1.14|0.72|
72471614|NCT00474526|144466761|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the ratio of pertussis GMCs (GMCLA1 / GMCLA2) must be greater than 0.67; the lower limit of the 95% CI for the ratio of all other GMCs (GMCLA1 / GMCLA2) must be greater than 0.50.|Ratio of GMCs|0.89|||||TWO_SIDED|95.0|0.74|1.08|||ANOVA|||PnC 18C (Post-vaccination GMC; group ratio LA1:LA2)||1.08|0.74|
72505950|NCT02760407|144543419|NON_INFERIORITY|Non-Inferiority for each OKZ dosing regimen versus Adalimumab is achieved if the lower limit of the 97.5% confidence interval is greater than the protocol defined non-inferiority margin of -12%.|Risk Difference (RD)|0.034|||||TWO_SIDED|97.5|-0.035|0.102||||||A noninferiority margin of 12% was used for the comparison between OKZ and adalimumab with respect to this endpoint.||0.102|-0.035|
72505951|NCT02760407|144543420|SUPERIORITY||Risk Difference (RD)|0.332|||<|0.0001|TWO_SIDED|97.5|0.257|0.397|||Chi-squared|2x2 chi-square test||The DAS28 low disease activity (based on DAS28 \[CRP\] \<3.2) response rate at Week 12 is estimated to be 10% in the placebo group and 22% in the 64 mg q4w OKZ group, resulting in an expected difference of 12 percentage points between respective OKZ group and placebo.||0.397|0.257|<0.0001
72622915|NCT02796651|144775946|SUPERIORITY||LSMean difference|0.1||||0.004|TWO_SIDED|95.0|0.032|0.168|||Mixed Models Analysis|||||0.168|0.032|0.004
72471615|NCT00474526|144466761|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the ratio of pertussis GMCs (GMCLA1 / GMCLA2) must be greater than 0.67; the lower limit of the 95% CI for the ratio of all other GMCs (GMCLA1 / GMCLA2) must be greater than 0.50.|Ratio of GMCs|0.9|||||TWO_SIDED|95.0|0.74|1.1|||ANOVA|||PnC 19F (Post-vaccination GMC; group ratio LA1:LA2)||1.1|0.74|
72471616|NCT00474526|144466761|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the ratio of pertussis GMCs (GMCLA1 / GMCLA2) must be greater than 0.67; the lower limit of the 95% CI for the ratio of all other GMCs (GMCLA1 / GMCLA2) must be greater than 0.50.|Ratio of GMCs|0.77|||||TWO_SIDED|95.0|0.6|0.99|||ANOVA|||PnC 23F (Post-vaccination GMC; group ratio LA1:LA2)||0.99|0.6|
72471617|NCT00474526|144466761|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA3 over LA4, the lower limit of two-sided 95% CI for the ratio of pertussis GMCs (GMCLA3 / GMCLA4) must be greater than 0.67; the lower limit of the two-sided 95% CI for the ratio of GMCs (GMCLA3 / GMCLA4) or GMTs (poliovirus antigens) for the other antigens must be greater than 0.50.|Ratio of GMCs|0.82|||||TWO_SIDED|95.0|0.69|0.99|||ANOVA|||Diphtheria (Post-vaccination GMC; group ratio LA3:LA4)||0.99|0.69|
72396204|NCT00372112|144298461|SUPERIORITY||Mean Difference (Net)|0.05|||||TWO_SIDED|95.0|-0.25|0.35|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline potassium, gender, age and treatment.||Placebo versus GW642444 100 mcg once daily for minimum potassium 0-4 h at Day 15.||0.35|-0.25|
72396205|NCT00372112|144298461|SUPERIORITY||Mean Difference (Net)|-0.35|||||TWO_SIDED|95.0|-0.66|-0.05|||Regression, Linear|||Placebo versus GW642444 400 mcg once daily for minimum potassium 0-4 h at Day 15.||-0.05|-0.66|
72396206|NCT00372112|144298461|SUPERIORITY||Mean Difference (Net)|0.04|||||TWO_SIDED|95.0|-0.26|0.34|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline potassium, gender, age and treatment.||Placebo versus Salmeterol 50 mcg BD for minimum potassium 0-4 h at Day 15.||0.34|-0.26|
72396207|NCT04649060|144298474|SUPERIORITY||Hazard Ratio (HR)|0.184|||=|0.0032|TWO_SIDED|95.0|0.052|0.65|||Log Rank|||||0.650|0.052|=0.0032
72396208|NCT04649060|144298475|SUPERIORITY|||||||0.03|||||||Cochran-Mantel-Haenszel|||||||0.03
72396209|NCT04649060|144298476|SUPERIORITY||Hazard Ratio (HR)|0.418||||0.525|TWO_SIDED|95.0|0.026|6.693|||Log Rank|||||6.693|0.026|0.525
72396210|NCT04649060|144298478|SUPERIORITY|||||||0.0997|||||||Cochran-Mantel-Haenszel|||||||0.0997
72396211|NCT04649060|144298479|SUPERIORITY||Hazard Ratio (HR)|0.111||||0.016|TWO_SIDED|95.0|0.013|0.96|||Log Rank|||||0.960|0.013|0.016
72396212|NCT04649060|144298481|SUPERIORITY||Hazard Ratio (HR)|0.231||||0.0187|TWO_SIDED|95.0|0.063|0.846|||Log Rank|||||0.846|0.063|0.0187
72471618|NCT00474526|144466761|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA3 over LA4, the lower limit of two-sided 95% CI for the ratio of pertussis GMCs (GMCLA3 / GMCLA4) must be greater than 0.67; the lower limit of the two-sided 95% CI for the ratio of GMCs (GMCLA3 / GMCLA4) or GMTs (poliovirus antigens) for the other antigens must be greater than 0.50.|Ratio of GMCs|0.95|||||TWO_SIDED|95.0|0.83|1.09|||ANOVA|||Tetanus (Post-vaccination GMC; group ratio LA3:LA4)||1.09|0.83|
72396213|NCT04649060|144298482|SUPERIORITY||Hazard Ratio (HR)|0.224||||0.0384|TWO_SIDED|95.0|0.047|1.056|||Log Rank|||||1.056|0.047|0.0384
72396214|NCT04649060|144298483|SUPERIORITY||Hazard Ratio (HR)|0.47||||0.3721|TWO_SIDED|95.0|0.086|2.569|||Log Rank|||||2.569|0.086|0.3721
72396215|NCT02648178|144298484|OTHER|We used a linear mixed model to estimate associations between cigarette smoking and that of e-cigarette smoking, by week and their interactions. We also used the same model to estimate association between biomarkers such as NNAL (4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol), Nicotine, Cotinine, Hydro and Creatinine and CO (Carbon Monoxide) level,by week and their interactions.||||||||||||We tested whether there were significant associations between cigarette smoking and e-cigarette smoking, as well as whether there were significant associations between biomarkers mentioned above with CO level.||We provided estimated values of coefficients from model and their 95% confidence intervals.|||We used a linear mixed model to estimate associations between cigarette smoking and that of e-cigarette smoking, week and their interactions. We also used the same model to estimate association between biomarkers such as NNAL, Nicotine, Cotinine, Hydro and Creatinine and CO level, week and their interactions.|||
72396216|NCT02205814|144298486|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|||||Fourhundred evaluable patients were supposed to provide approximately 80% power in rejecting the null hypothesis of equality between any dose of fasitibant and placebo based on previous results and an overall significance level of 5% (two-sided).|mixed linear model for repeated measures|||||||<0.05
72396217|NCT02205814|144298487|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|||||Fourhundred evaluable patients were supposed to provide approximately 80% power in rejecting the null hypothesis of equality between any dose of fasitibant and placebo based on previous results and an overall significance level of 5% (two-sided).|mixed linear model for repeated measures|||All secondary efficacy variables were analysed on the ITT population only. Multiplicity was adjusted using the Hochberg procedure. The continuous secondary efficacy variables were analysed over time and were treated in the same way as the primary efficacy variable with respective output.||||<0.05
72396218|NCT01285310|144298519|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|-7.4||||0.3134|TWO_SIDED|95.0|-27.1|7.0|||Chi-squared||2-sided 95% CI of the proportion difference is based on a normal approximation to the binomial distribution|Significance testing was done using the following closed procedure; if the overall test among treatments is statistically significant at the 0.05 level, pair-wise comparisons (30 mg versus PBO, and 20 mg versus PBO, using a 0.05 two-sided significance level) will be performed||7.0|-27.1|0.3134
72471619|NCT00474526|144466761|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA3 over LA4, the lower limit of two-sided 95% CI for the ratio of pertussis GMCs (GMCLA3 / GMCLA4) must be greater than 0.67; the lower limit of the two-sided 95% CI for the ratio of GMCs (GMCLA3 / GMCLA4) or GMTs (poliovirus antigens) for the other antigens must be greater than 0.50.|Ratio of GMCs|0.93||||||95.0|0.78|1.1|||ANOVA|||PT (Post-vaccination GMC; group ratio LA3:LA4)||1.1|0.78|
72396219|NCT01285310|144298519|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|-1.2||||0.8721|TWO_SIDED|95.0|-16.2|13.8|||Chi-squared||2-sided 95% CI is based on a normal approximation to the binomial distribution|||13.8|-16.2|0.8721
72622916|NCT02796651|144775946|SUPERIORITY||LSMean difference|0.059||||0.075|TWO_SIDED|95.0|-0.006|0.123|||Mixed Models Analysis|||||0.123|-0.006|0.075
72396220|NCT01285310|144298520|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.004|||||||||||||Based on an analysis of covariance model for the change from baseline at Week 16, with treatment group as a factor and the baseline value as a covariate.|||||
72396221|NCT01285310|144298520|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.091|||||||||||||Based on an analysis of covariance model for the change from baseline at Week 16, with treatment group as a factor and the baseline value as a covariate.|||||
72396222|NCT01285310|144298521|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|-4.5||||||||||||||||||
72396223|NCT01285310|144298521|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|3.6||||||||||||||||||
72396224|NCT01285310|144298522|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.007||||||||||||Based on an analysis of covariance model for the change from baseline at Week 24; treatment group as a factor and the baseline value as a covariate.||||||
72396225|NCT01285310|144298522|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.15|||||||||||||Based on an analysis of covariance model for the change from baseline at Week 24, treatment group as a factor and the baseline value as a covariate.|||||
72396226|NCT01285310|144298523|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.17|||||||||||||Based on an analysis of covariance model for the change from baseline at Week 16; treatment group as a factor and the baseline value as a covariate|||||
72622917|NCT02796651|144775946|SUPERIORITY||LSMean difference|-0.01||||0.615|TWO_SIDED|95.0|-0.048|0.028|||Mixed Models Analysis|||||0.028|-0.048|0.615
72396227|NCT01285310|144298523|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|1.77|||||||||||||Based on an analysis of covariance model for the change from baseline at Week 16; treatment group as a factor and the baseline value as a covariate.|||||
72396228|NCT01285310|144298524|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|1.21||||||||||||Based on an analysis of covariance model for the change from baseline at Week 16; treatment group as a factor and the baseline value as a covariate.||||||
72396229|NCT01285310|144298524|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.7||||||||||||Based on an analysis of covariance model for the change from baseline at Week 24; treatment group as a factor and the baseline value as a covariate.||||||
72396230|NCT01285310|144298525|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|-5.5||||||||||||||||||
72396231|NCT01285310|144298525|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|-7.2||||||||||||||||||
72396232|NCT01285310|144298526|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.14||||||||||||Based on an analysis of covariance model for the change from baseline at Week 16, treatment group as a factor and the baseline value as a covariate.||||||
72396233|NCT01285310|144298526|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-0.02|||||TWO_SIDED|||||||Based on an analysis of covariance model for the change from baseline at Week 24; treatment group as a factor and the baseline value as a covariate.||||||
72396234|NCT01285310|144298527|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|6.15|||||||||||||Based on an analysis of covariance model (Ancova) for the change from baseline at Week 16, with treatment group as a factor and the baseline value as a covariate|||||
72471620|NCT00474526|144466761|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA3 over LA4, the lower limit of two-sided 95% CI for the ratio of pertussis GMCs (GMCLA3 / GMCLA4) must be greater than 0.67; the lower limit of the two-sided 95% CI for the ratio of GMCs (GMCLA3 / GMCLA4) or GMTs (poliovirus antigens) for the other antigens must be greater than 0.50.|Ratio of GMCs|0.88|||||TWO_SIDED|95.0|0.75|1.03|||ANOVA|||FHA (Post-vaccination GMC; group ratio LA3:LA4)||1.03|0.75|
72396235|NCT01285310|144298527|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.61|||||||||||||Based on an analysis of covariance model (Ancova) for the change from baseline at Week 16, with treatment group as a factor and the baseline value as a covariate|||||
72396236|NCT01285310|144298528|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|2.58|||||TWO_SIDED||||||||Based on an analysis of covariance model for the change from baseline at Week 16, with treatment group as a factor and the baseline value as a covariate.|||||
72396237|NCT01285310|144298528|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-3.26||||||||||||||||||
72396238|NCT01285310|144298529|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-35.54|||||||||||||Based on an analysis of covariance model for the change from baseline at Week 16, with treatment group as a factor and the baseline value as a covariate.|||||
72396239|NCT01285310|144298529|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-38.37|||||||||||||Based on an analysis of covariance model for the change from baseline at Week 16, with treatment group as a factor and the baseline value as a covariate.|||||
72396240|NCT01285310|144298530|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-14.35|||||||||||||Based on an analysis of covariance model for the change from baseline at Week 16, with treatment group as a factor and the baseline value as a covariate.|||||
72396241|NCT01285310|144298530|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|0.34|||||||||||||Based on an analysis of covariance model for the change from baseline at Week 16, with treatment group as a factor and the baseline value as a covariate.|||||
72396242|NCT01285310|144298531|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|0.59|||||TWO_SIDED||||||||Based on an analysis of covariance model for the change from baseline at Week 16, with treatment group as a factor and the baseline value as a covariate.|||||
72396243|NCT01285310|144298531|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-3.84|||||||||||||Based on an analysis of covariance model for the change from baseline at Week 16, with treatment group as a factor and the baseline value as a covariate.|||||
72396244|NCT01285310|144298532|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|5.93|||||||||||||Based on an analysis of covariance model for the change from baseline at Week 16, with treatment group as a factor and the baseline value as a covariate.|||||
72396245|NCT01285310|144298532|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.77|||||||||||||Based on an analysis of covariance model for the change from baseline at Week 16, with treatment group as a factor and the baseline value as a covariate|||||
72396246|NCT01285310|144298533|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|4.7|||||||||||||Based on an analysis of covariance model for the change from baseline at Week 16, with treatment group as a factor and the baseline value as a covariate.|||||
72396247|NCT01285310|144298533|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|58.05||||||||||||||||||
72396248|NCT01285310|144298534|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|7.18|||||||||||||Based on an analysis of covariance model for the change from baseline at Week 16, with treatment group as a factor and the baseline value as a covariate.|||||
72396249|NCT01285310|144298534|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-16.19|||||||||||||Based on an analysis of covariance model for the change from baseline at Week 16, with treatment group as a factor and the baseline value as a covariate.|||||
72396250|NCT01285310|144298535|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.2|||||||||||||Based on an analysis of covariance model for the change from baseline at Week 16, with treatment group as a factor and the baseline value as a covariate.|||||
72396251|NCT01285310|144298535|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-0.1|||||||||||||Based on an analysis of covariance model for the change from baseline at Week 16, with treatment group as a factor and the baseline value as a covariate|||||
72396252|NCT01285310|144298536|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|-3.9||||||||||||||||||
72396253|NCT01285310|144298536|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|13.4||||||||||||||||||
72396254|NCT01285310|144298537|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|-3.9||||||||||||||||||
72396255|NCT01285310|144298537|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|2.9||||||||||||||||||
72396256|NCT01285310|144298538|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|-5.4||||||||||||||||||
72396257|NCT01285310|144298538|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|2.1||||||||||||||||||
72396258|NCT01285310|144298539|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|-6.5||||||||||||||||||
72471621|NCT00474526|144466761|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA3 over LA4, the lower limit of two-sided 95% CI for the ratio of pertussis GMCs (GMCLA3 / GMCLA4) must be greater than 0.67; the lower limit of the two-sided 95% CI for the ratio of GMCs (GMCLA3 / GMCLA4) or GMTs (poliovirus antigens) for the other antigens must be greater than 0.50.|Ratio of GMCs|0.8|||||TWO_SIDED|95.0|0.66|0.97|||ANOVA|||Pertactin (Post-vaccination GMC; group ratio LA3:LA4||0.97|0.66|
72396259|NCT01285310|144298539|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|-2.2||||||||||||||||||
72396260|NCT01285310|144298540|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|-1.3||||||||||||||||||
72396261|NCT01285310|144298540|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|-2.5||||||||||||||||||
72396262|NCT01285310|144298541|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|-1.5||||||||||||||||||
72396263|NCT01285310|144298541|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|9.5||||||||||||||||||
72396264|NCT01285310|144298542|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|-1.4|||||TWO_SIDED|||||||||||||
72396265|NCT01285310|144298542|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|1.5|||||TWO_SIDED|||||||||||||
72396266|NCT01285310|144298543|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.12|||||||||||||Based on an analysis of covariance model for the change from baseline at Week 24 with treatment group as a factor and the baseline value as a covariate.|||||
72622918|NCT02796651|144775946|SUPERIORITY||LSMean difference|0.025||||0.209|TWO_SIDED|95.0|-0.014|0.065|||Mixed Models Analysis|||||0.065|-0.014|0.209
72396267|NCT01285310|144298543|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|1.98|||||||||||||Based on an analysis of covariance model for the change from baseline at Week 24 with treatment group as a factor and the baseline value as a covariate.|||||
72396268|NCT01285310|144298544|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.94||||||||||||Based on an analysis of covariance model for the change from baseline at Week 24; treatment group as a factor and the baseline value as a covariate.||||||
72396269|NCT01285310|144298544|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-1.24||||||||||||Based on an analysis of covariance model for the change from baseline at Week 24; treatment group as a factor and the baseline value as a covariate.||||||
72471622|NCT00474526|144466761|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA3 over LA4, the lower limit of two-sided 95% CI for the ratio of pertussis GMCs (GMCLA3 / GMCLA4) must be greater than 0.67; the lower limit of the two-sided 95% CI for the ratio of GMCs (GMCLA3 / GMCLA4) or GMTs (poliovirus antigens) for the other antigens must be greater than 0.50.|Ratio of GMTs|0.78|||||TWO_SIDED|95.0|0.6|1.02|||ANOVA|||Polio Type 1 (Post-vaccination GMT; group ratio LA3:LA4)||1.02|0.6|
72396270|NCT01285310|144298545|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportions|-4.3||||||||||||||||||
72396271|NCT01285310|144298545|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportions|4.6||||||||||||||||||
72396272|NCT01285310|144298546|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.03|||||||||||||Based on an analysis of covariance model for the change from baseline at Week 24 with treatment group as a factor and the baseline value as a covariate.|||||
72396273|NCT01285310|144298546|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.09|||||||||||||Based on an analysis of covariance model for the change from baseline at Week 24 with treatment group as a factor and the baseline value as a covariate.|||||
72396274|NCT01285310|144298547|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|4.6|||||||||||||Based on an analysis of covariance model for the change from baseline at Week 24, with treatment group as a factor and the baseline value as a covariate.|||||
72396275|NCT01285310|144298547|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|3.01|||||||||||||Based on an analysis of covariance model for the change from baseline at Week 24; treatment group as a factor and the baseline value as a covariate.|||||
72396276|NCT01285310|144298548|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|1.86|||||||||||||Based on an analysis of covariance model for the change from baseline at Week 24, with treatment group as a factor and the baseline value as a covariate|||||
72396277|NCT01285310|144298548|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-7.02|||||||||||||Based on an analysis of covariance model for the change from baseline at Week 24, with treatment group as a factor and the baseline value as a covariate|||||
72396278|NCT01285310|144298549|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-34.82|||||||||||||Based on an analysis of covariance model for the change from baseline at Week 24, with treatment group as a factor and the baseline value as a covariate|||||
72396279|NCT01285310|144298549|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-37.82|||||||||||||Based on an analysis of covariance model for the change from baseline at Week 24, with treatment group as a factor and the baseline value as a covariate|||||
72396280|NCT01285310|144298550|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-14.34|||||||||||||Based on an analysis of covariance model for the change from baseline at Week 24, with treatment group as a factor and the baseline value as a covariate.|||||
72396281|NCT01285310|144298550|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-12.5|||||||||||||Based on an analysis of covariance model for the change from baseline at Week 24, with treatment group as a factor and the baseline value as a covariate.|||||
72396282|NCT01285310|144298551|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|5.85|||||||||||||Based on an analysis of covariance model for the change from baseline at Week 24, with treatment group as a factor and the baseline value as a covariate.|||||
72396283|NCT01285310|144298551|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-1.8|||||||||||||Based on an analysis of covariance model for the change from baseline at Week 24, with treatment group as a factor and the baseline value as a covariate.|||||
72396284|NCT01285310|144298552|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|1.57|||||||||||||Based on an analysis of covariance model for the change from baseline at Week 24, with treatment group as a factor and the baseline value as a covariate.|||||
72396285|NCT01285310|144298552|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-5.72|||||||||||||Based on an analysis of covariance model for the change from baseline at Week 24, with treatment group as a factor and the baseline value as a covariate.|||||
72396286|NCT01285310|144298553|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|8.29|||||||||||||Based on an analysis of covariance model for the change from baseline at Week 24, with treatment group as a factor and the baseline value as a covariate.|||||
72396287|NCT01285310|144298553|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|67.09|||||||||||||Based on an analysis of covariance model for the change from baseline at Week 24, with treatment group as a factor and the baseline value as a covariate.|||||
72396288|NCT01285310|144298554|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|12.05|||||||||||||Based on an analysis of covariance model for the change from baseline at Week 24, with treatment group as a factor and the baseline value as a covariate.|||||
72471623|NCT00474526|144466761|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA3 over LA4, the lower limit of two-sided 95% CI for the ratio of pertussis GMCs (GMCLA3 / GMCLA4) must be greater than 0.67; the lower limit of the two-sided 95% CI for the ratio of GMCs (GMCLA3 / GMCLA4) or GMTs (poliovirus antigens) for the other antigens must be greater than 0.50.|Ratio of GMTs|0.83|||||TWO_SIDED|95.0|0.63|1.09|||ANOVA|||Polio Type 2 (Post-vaccination GMT; group ratio LA3:LA4)||1.09|0.63|
72396289|NCT01285310|144298554|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-6.54|||||||||||||Based on an analysis of covariance model for the change from baseline at Week 24, with treatment group as a factor and the baseline value as a covariate.|||||
72396290|NCT01285310|144298555|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.2|||||||||||||Based on an analysis of covariance model for the change from baseline at Week 24, with treatment group as a factor and the baseline value as a covariate|||||
72396291|NCT01285310|144298555|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|1.7|||||||||||||Based on an analysis of covariance model for the change from baseline at Week 24, with treatment group as a factor and the baseline value as a covariate|||||
72396292|NCT01285310|144298556|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|5.4||||||||||||||||||
72396293|NCT01285310|144298556|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|12.6||||||||||||||||||
72396294|NCT01285310|144298557|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|-11.9||||||||||||||||||
72396295|NCT01285310|144298557|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|-0.3||||||||||||||||||
72396296|NCT01285310|144298558|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|-11.2||||||||||||||||||
72396297|NCT01285310|144298558|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|-5.0||||||||||||||||||
72396298|NCT01867021|144298699|NON_INFERIORITY_OR_EQUIVALENCE|The HI GMTs of TIV vaccine for strain A/H1N1 considered non-inferior to HI GMTs of TIVf vaccine if the upper limit of the two-sided 95% CI on the ratio of GMTs (GMT TIVf / GMT TIV) was ≤1.5|Ratio of GMTs|1.85|||||TWO_SIDED|95.0|1.66|2.06|||ANCOVA|Not applicable(NA)||Non-inferiority of HI GMTs of TIV vaccine over HI GMTs of TIVf vaccine for the strain A/H1N1 at day 22||2.06|1.66|
72396299|NCT01867021|144298699|NON_INFERIORITY_OR_EQUIVALENCE|The HI GMTs of TIV vaccine for strain A/H3N2 considered non-inferior to HI GMTs of TIVf vaccine if the upper limit of the two-sided 95% CI on the ratio of GMTs (GMT TIVf / GMT TIV) was ≤1.5|Ratio of GMTs|1.5|||||TWO_SIDED|95.0|1.38|1.64|||ANCOVA|||Non-inferiority of HI GMTs of TIV vaccine over HI GMTs of TIVf vaccine for the strain A/H3N2 at day 22||1.64|1.38|
72396300|NCT01867021|144298699|NON_INFERIORITY_OR_EQUIVALENCE|The HI GMTs of TIV vaccine for strain B considered non-inferior to HI GMTs of TIVf vaccine if the upper limit of the two-sided 95% CI on the ratio of GMTs (GMT TIVf / GMT TIV) was ≤1.5|Ratio of GMTs|1.0|||||TWO_SIDED|95.0|0.93|1.08|||ANCOVA|||Non-inferiority of HI GMTs of TIV vaccine over HI GMTs of TIVf vaccine for the strain B at day 22||1.08|0.93|
72396301|NCT01867021|144298700|NON_INFERIORITY_OR_EQUIVALENCE|Percentage of subjects with HI seroconversion of TIV vaccine for strain A/H1N1 considered non-inferior to percentage of subjects with HI seroconversion of TIVf vaccine if the upper limit of the two-sided 95% CI on the difference between the seroconversion rates (Seroconversion TIVf - Seroconversion TIV) was ≤10%.|Difference in seroconversion rates|9.0|||||TWO_SIDED|95.0|5.6|11.5|||Miettinen and Nurminen|||Non-inferiority of percentage of subjects with HI seroconversion of TIV vaccine over TIVf vaccine for the strain A/H1N1 at day 22||11.5|5.6|
72396302|NCT01867021|144298700|NON_INFERIORITY_OR_EQUIVALENCE|Percentage of subjects with HI seroconversion of TIV vaccine for strain A/H3N2 considered non-inferior to percentage of subjects with HI seroconversion of TIVf vaccine if the upper limit of the two-sided 95% CI on the difference between the seroconversion rates (Seroconversion TIVf - Seroconversion TIV) was ≤10%.|Difference in seroconversion rates|13.0|||||TWO_SIDED|95.0|10.1|16.1|||Miettinen and Nurminen|||Non-inferiority of percentage of subjects with HI seroconversion of TIV vaccine over TIVf vaccine for the strain A/H3N2 at day 22||16.1|10.1|
72396303|NCT01867021|144298700|NON_INFERIORITY_OR_EQUIVALENCE|Percentage of subjects with HI seroconversion of TIV vaccine for strain B considered non-inferior to percentage of subjects with HI seroconversion of TIVf vaccine if the upper limit of the two-sided 95% CI on the difference between the seroconversion rates (Seroconversion TIVf - Seroconversion TIV) was ≤10%.|Difference in seroconversion rates|-1.0|||||TWO_SIDED|95.0|-5.0|2.3|||Miettinen and Nurminen|||Non-inferiority of percentage of subjects with HI seroconversion of TIV vaccine over TIVf vaccine for the strain B at day 22||2.3|-5|
72396304|NCT01862874|144298736|SUPERIORITY||Vaccine Efficacy|85.9|||<|0.001|TWO_SIDED|95.0|52.7|97.3|||One-sided exact test||Vaccine efficacy is defined as the percentage reduction in relative risk for the V501 group versus the placebo group.||If the lower bound of the 95% confidence interval for vaccine efficacy excludes 0%, then superiority of the V501 group is demonstrated.|97.3|52.7|<0.001
72396305|NCT01862874|144298737|OTHER|Statistical testing of no difference in incidence of maximum temperature ≥37.5°C|Risk Difference (RD)|-1.2||||0.256|TWO_SIDED|95.0|-3.5|0.9|||Miettinen & Nurminen||Risk difference (V501 - placebo) was estimated using the Miettinen \& Nurminen method.|||0.9|-3.5|0.256
72396306|NCT01862874|144298738|OTHER|Statistical testing of no difference in incidence of injection-site erythema|Risk Difference (RD)|2.9||||0.251|TWO_SIDED|95.0|-2.1|7.9|||Miettinen & Nurminen||Risk difference (V501 - placebo) was estimated using the Miettinen \& Nurminen method.|Injection-site erythema||7.9|-2.1|0.251
72396307|NCT01862874|144298738|OTHER|Statistical testing of no difference in incidence of injection-site pain|Risk Difference (RD)|6.4||||0.033|TWO_SIDED|95.0|0.5|12.2|||Miettinen & Nurminen||Risk difference (V501 - placebo) was estimated using the Miettinen \& Nurminen method.|Injection-site pain||12.2|0.5|0.033
72396308|NCT01862874|144298738|OTHER|Statistical testing of no difference in incidence of injection-site swelling|Risk Difference (RD)|6.8||||0.003|TWO_SIDED|95.0|2.3|11.3|||Miettinen & Nurminen||Risk difference (V501 - placebo) was estimated using the Miettinen \& Nurminen method.|Injection-site swelling||11.3|2.3|0.003
72396309|NCT01862874|144298739|OTHER|Statistical testing of no difference in incidence of systemic AEs|Risk Difference (RD)|-0.9|||||TWO_SIDED|95.0|-5.2|3.3|||||Risk difference (V501 - placebo) was estimated using the Miettinen \& Nurminen method.|||3.3|-5.2|
72396310|NCT01862874|144298740|OTHER|Statistical testing of no difference in incidence of vaccine-related systemic AEs|Risk Difference (RD)|-1.6|||||TWO_SIDED|95.0|-4.1|0.8|||||Risk difference (V501 - placebo) was estimated using the Miettinen \& Nurminen method.|||0.8|-4.1|
72396311|NCT01862874|144298741|SUPERIORITY||Vaccine Efficacy|86.5|||<|0.001|TWO_SIDED|95.0|55.2|97.4|||One-sided exact test||Vaccine efficacy is defined as the percentage reduction in relative risk for the V501 versus the placebo group.||If the lower bound of the 95% confidence interval for vaccine efficacy excludes 0%, superiority of the V501 group is demonstrated.|97.4|55.2|<0.001
72396312|NCT01244425|144298742|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||likelihood-ratio chi square test|||||||<0.001
72396313|NCT01244425|144298743|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||likelihood ratio chi-square test|||||||<0.001
72396314|NCT01244425|144298744|SUPERIORITY_OR_OTHER|||||||0.028||95.0|||||likelihood ratio chi-square test|||||||0.028
72396315|NCT01244425|144298745|SUPERIORITY_OR_OTHER|||||||0.017||95.0|||||likelihood ratio chi-square test|||||||0.017
72396316|NCT01244425|144298746|SUPERIORITY_OR_OTHER|||||||0.293||95.0|||||likelihood ratio chi-square test|||||||0.293
72396317|NCT01244425|144298747|SUPERIORITY_OR_OTHER|||||||0.237||95.0|||||likelihood ratio chi-square test|||||||0.237
72396318|NCT01244425|144298748|SUPERIORITY_OR_OTHER|||||||0.808||95.0|||||likelihood ratio chi-square test|||||||0.808
72396319|NCT02421315|144298773|OTHER|a t-test comparing groups in a specific region-of-interest (ROI); the insula|Mean Difference (Final Values)|0.11|STANDARD_ERROR_OF_MEAN|0.057||0.0585|TWO_SIDED|95.0|-0.004|0.224|||t-test, 2 sided|||We hypothesized that compared to HC, children and adolescents with OCD would have increased activation in subcortical structures (insula, and putamen) comprising a right hemisphere dorsal frontostriatal circuit.||0.224|-0.004|0.0585
72396320|NCT02421315|144298774|SUPERIORITY|We selected 'arbitrary units' as the unit of measure here because we are looking at connectivity strengths|Mean Difference (Final Values)|0.49512921|STANDARD_ERROR_OF_MEAN|0.06553315||0.037|TWO_SIDED|||||"NBS controls for family-wise error rate using permutation testing to identify components or clusters of contiguous region-to-region connections. A statistical threshold of p\<.05 with 20,000 permutations was used."|t-test, 1 sided||Direction of the comparison: HC\>OCD|Whole-Brain Connectome-Level Analyses were performed on the FC-strength indices between 352 regions. Edge-wise functional connectivity analyses was then be conducted across the resulting matrix comprised of 352 nodes and 123,904 edges, using the Network-Based Statistics (NBS) Toolbox. We hypothesized that youth with OCD would show altered FC between task-control circuit regions.||||.037
72396321|NCT02421315|144298774|OTHER||Slope|-0.521|||<|0.05|TWO_SIDED||||||Regression, Linear|||Separate cross-lagged panel models were computed in the OCD group for the three functional connections that differed significantly across groups at baseline (see Statistical Analysis 1). These models were constructed using IBM SPSS Amos (v.23) to test for directional relationships between OCD symptoms and FC pre- to post-treatment in the OCD patients. CY-BOCS total scores at each time point were used as the OCD symptoms measure.||||<.05
72396322|NCT02421315|144298775|SUPERIORITY||Mean Difference (Final Values)|0.11||||0.0464|TWO_SIDED|95.0|0.0018|0.218|||t-test, 2 sided|||||0.218|0.0018|0.0464
72396323|NCT02421315|144298776|SUPERIORITY|only participants were assigned to groups (OCD, HC) and we measured streamline count in these participants to index structural connectivity|Slope|-102.67|||<|0.025|TWO_SIDED|||||"NBS controls for family-wise error rate using permutation testing to identify components or clusters of contiguous region-to-region connections. A statistical threshold of p=.025 with 10,000 permutations was used."|Regression, Linear||Direction of comparison: HC\>OCD|Whole-Brain Connectome-Level Analyses were performed on the structural connectivity indices (streamline count) between 164 regions. Edge-wise structural connectivity analyses was then be conducted across the resulting matrix comprised of 164 nodes and 26,896 edges, using the Network-Based Statistics (NBS) Toolbox.||||<0.025
72396324|NCT02480114|144298785|SUPERIORITY||Odds Ratio (OR)|0.549||||0.004|TWO_SIDED|95.0|0.364|0.827|||Proportional Odds Regression|||||0.827|0.364|0.004
72396325|NCT02480114|144298786|SUPERIORITY||Odds Ratio (OR)|1.0||||1|TWO_SIDED||||||Fisher Exact|||||||1
72396326|NCT02480114|144298787|SUPERIORITY||Odds Ratio (OR)|0.371|||<|0.001|TWO_SIDED|95.0|0.244|0.597|||Proportional Odds Regression|||||0.597|0.244|<0.001
72396327|NCT04346537|144298818|SUPERIORITY||||||<|0.001|||||||Wilcoxon signed rank test|||||||< 0.001
72396328|NCT04346537|144298819|SUPERIORITY||||||<|0.001|||||||Wilcoxon signed rank test|||||||< 0.001
72396329|NCT04346537|144298820|OTHER|Two-one sided t-tests (TOST) -- the 90% confidence interval was required to be contained with 300 and 1300 ohms.|||||<|0.001|||||||Two one-sided t-tests|||||||< 0.001
72396330|NCT01134783|144298821|SUPERIORITY_OR_OTHER|||||||0.707|TWO_SIDED|||||The analysis used hierarchical linear models having repeated measures of the outcome regressed on experimental condition, adjusted for baseline age, sex, race, and household education level as well as wave and college.|Regression, Logistic|||||||0.707
72396331|NCT01134783|144298822|SUPERIORITY_OR_OTHER|||||||0.049|TWO_SIDED|||||The analysis used hierarchical linear models having repeated measures of the outcome regressed on experimental condition, adjusted for baseline age, sex, race, and household education level as well as wave and college.|Regression, Logistic|||||||0.049
72396332|NCT01404325|144298832|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|||||||<0.0001
72396333|NCT03454581|144298867|SUPERIORITY||Mean Difference (Final Values)|0.05|||<|0.001|TWO_SIDED|95.0|||||Regression, Linear|||||||<0.001
72396334|NCT03454581|144298868|SUPERIORITY_OR_OTHER_LEGACY|||||||0.05|||||||Generalized Estimating Equation|||||||0.05
72396335|NCT03454581|144298869|SUPERIORITY_OR_OTHER_LEGACY|||||||0.05|||||||Generalized Estimating Equation|||||||0.05
72396336|NCT03454581|144298870|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05|||||||Generalized Estimating Equation|||||||<0.05
72396337|NCT03454581|144298871|OTHER||||||<|0.01|||||||Generalized Estimating Equation|||||||<0.01
72396338|NCT03454581|144298872|SUPERIORITY_OR_OTHER_LEGACY|||||||0.05|||||||Generalized Estimating Equation|||||||0.05
72396339|NCT03454581|144298873|SUPERIORITY_OR_OTHER_LEGACY|||||||0.05|||||||Generalized Estimating Equation|||||||0.05
72396340|NCT03454581|144298874|SUPERIORITY_OR_OTHER_LEGACY|||||||0.05|||||||Generalized Estimating Equation|||||||0.05
72396341|NCT01034462|144298875|SUPERIORITY_OR_OTHER||Least squares mean difference|-3.095||||0.0051|TWO_SIDED|95.0|-5.256|-0.935|||Mixed Models Analysis|Mixed-effects model for repeated measures.||||-0.935|-5.256|0.0051
72396342|NCT01034462|144298876|SUPERIORITY_OR_OTHER||Least squares mean difference|-2.632||||0.001|TWO_SIDED|95.0|-4.193|-1.07|||Mixed Models Analysis|Mixed-effects model for repeated measures.||||-1.070|-4.193|0.0010
72396343|NCT02618434|144298892|SUPERIORITY||Median Difference (Net)|-0.56||||0.9383|TWO_SIDED|95.0|-8.96|7.84|||Wilcoxon (Mann-Whitney)|||||7.84|-8.96|0.9383
72396344|NCT02618434|144298893|SUPERIORITY||Mean Difference (Net)|-0.15|STANDARD_ERROR_OF_MEAN|0.09||0.0979|TWO_SIDED|95.0|-0.33|0.03|||Mixed Models Analysis|||This analysis pertains to Visit 4||0.03|-0.33|0.0979
72396345|NCT02618434|144298893|SUPERIORITY||Mean Difference (Net)|-0.25|STANDARD_ERROR_OF_MEAN|0.126||0.0502|TWO_SIDED|95.0|-0.5|0.0|||Mixed Models Analysis|||This analysis pertains to Visit 5||0.00|-0.50|0.0502
72396346|NCT02618434|144298893|SUPERIORITY||Mean Difference (Net)|-0.1|STANDARD_ERROR_OF_MEAN|0.141||0.4769|TWO_SIDED|95.0|-0.38|0.18|||Mixed Models Analysis|||This analysis pertains to Visit 6||0.18|-0.38|0.4769
72396347|NCT02618434|144298894|SUPERIORITY||Mean Difference (Net)|-0.19|STANDARD_ERROR_OF_MEAN|0.113||0.0881|TWO_SIDED|95.0|-0.41|0.03|||Mixed Models Analysis|||This analysis pertains to Visit 4||0.03|-0.41|0.0881
72396348|NCT02618434|144298894|SUPERIORITY||Mean Difference (Net)|-0.26|STANDARD_ERROR_OF_MEAN|0.135||0.0522|TWO_SIDED|95.0|-0.53|0.0|||Mixed Models Analysis|||This analysis pertains to Visit 5||0.00|-0.53|0.0522
72396349|NCT02618434|144298894|SUPERIORITY||Mean Difference (Net)|-0.21|STANDARD_ERROR_OF_MEAN|0.156||0.1766|TWO_SIDED|95.0|-0.52|0.1|||Mixed Models Analysis|||This analysis pertains to Visit 6||0.10|-0.52|0.1766
72396350|NCT02618434|144298895|SUPERIORITY||Mean Difference (Net)|1.54|STANDARD_ERROR_OF_MEAN|1.613||0.3409|TWO_SIDED|95.0|-1.64|4.72|||ANCOVA|||This analysis pertains to the Physical Functioning Summary Score at Visit 6.||4.72|-1.64|0.3409
72396351|NCT02618434|144298895|SUPERIORITY||Mean Difference (Net)|-2.21|STANDARD_ERROR_OF_MEAN|0.952||0.0215|TWO_SIDED|95.0|-4.08|-0.33|||ANCOVA|||This analysis pertains to the Psychosocial Health Summary Score at Visit 6.||-0.33|-4.08|0.0215
72396352|NCT02618434|144298896|SUPERIORITY||Mean Difference (Net)|-1.06|STANDARD_ERROR_OF_MEAN|2.0||0.5977|TWO_SIDED|95.0|-5.0|2.89|||ANCOVA|||This analysis pertains to the Total Score at Visit 6.||2.89|-5.00|0.5977
72396353|NCT02618434|144298896|SUPERIORITY||Mean Difference (Net)|0.2|STANDARD_ERROR_OF_MEAN|0.807||0.8049|TWO_SIDED|95.0|-1.39|1.79|||ANCOVA|||This analysis pertains to the Parental Distress Domain score at Visit 6.||1.79|-1.39|0.8049
72396354|NCT02618434|144298896|SUPERIORITY||Mean Difference (Net)|0.11|STANDARD_ERROR_OF_MEAN|0.801||0.8911|TWO_SIDED|95.0|-1.47|1.69|||ANCOVA|||This analysis pertains to the Parent-Child Dysfunctional Interaction score at Visit 6.||1.69|-1.47|0.8911
72396355|NCT02618434|144298896|SUPERIORITY||Mean Difference (Net)|-1.25|STANDARD_ERROR_OF_MEAN|0.849||0.1426|TWO_SIDED|95.0|-2.93|0.42|||ANCOVA|||This analysis pertains to the Difficult Child Domain score Visit 6.||0.42|-2.93|0.1426
72396356|NCT02618434|144298897|SUPERIORITY||Mean Difference (Net)|-0.07|STANDARD_ERROR_OF_MEAN|0.134||0.6171|TWO_SIDED|95.0|-0.33|0.2|||Mixed Models Analysis|||This analysis pertains to Visit 4||0.20|-0.33|0.6171
72396357|NCT02618434|144298897|SUPERIORITY||Mean Difference (Net)|-0.27|STANDARD_ERROR_OF_MEAN|0.143||0.0617|TWO_SIDED|95.0|-0.55|0.01|||Mixed Models Analysis|||This analysis pertains to Visit 5||0.01|-0.55|0.0617
72396358|NCT02618434|144298897|SUPERIORITY||Mean Difference (Net)|-0.13|STANDARD_ERROR_OF_MEAN|0.171||0.4419|TWO_SIDED|95.0|-0.47|0.21|||Mixed Models Analysis|||This analysis pertains to Visit 6||0.21|-0.47|0.4419
72396359|NCT02618434|144298898|SUPERIORITY||Mean Difference (Net)|-0.16|STANDARD_ERROR_OF_MEAN|0.08||0.0416|TWO_SIDED|95.0|-0.32|-0.01|||ANCOVA|||This analysis pertains to the Inattention subscale at Visit 6.||-0.01|-0.32|0.0416
72396360|NCT02618434|144298898|SUPERIORITY||Mean Difference (Net)|-0.15|STANDARD_ERROR_OF_MEAN|0.089||0.0921|TWO_SIDED|95.0|-0.33|0.02|||ANCOVA|||This analysis pertains to Hyperactivity/Impulsivity subscale at Visit 6||0.02|-0.33|0.0921
72505952|NCT02760407|144543420|SUPERIORITY||Risk Difference (RD)|0.325|||<|0.0001|TWO_SIDED|97.5|0.25|0.391|||Chi-squared|2x2 chi-square test||The DAS28 low disease activity (based on DAS28 \[CRP\] \<3.2) response rate at Week 12 is estimated to be 10% in the placebo group and 30% in the 64 mg q2w OKZ group, resulting in an expected difference of 20 percentage points between respective OKZ group and placebo.||0.391|0.250|<0.0001
72396361|NCT02618434|144298898|SUPERIORITY||Mean Difference (Net)|-0.07|STANDARD_ERROR_OF_MEAN|0.094||0.448|TWO_SIDED|95.0|-0.26|0.11|||ANCOVA|||This analysis pertains to the Oppositional Defiant Disorder subscale at Visit 6||0.11|-0.26|0.4480
72396362|NCT02618434|144298898|SUPERIORITY||Mean Difference (Net)|-0.16|STANDARD_ERROR_OF_MEAN|0.077||0.0457|TWO_SIDED|95.0|-0.31|0.0|||ANCOVA|||This analysis pertains to the Combined Scale score at Visit 6||-0.00|-0.31|0.0457
72396363|NCT02618434|144298899|SUPERIORITY||Odds Ratio (OR)|1.06||||0.8525|TWO_SIDED|95.0|0.58|1.93|||Regression, Logistic|||This analysis pertains to ≥ 30% Responders.||1.93|0.58|0.8525
72505953|NCT02760407|144543421|SUPERIORITY||Risk Difference (RD)|0.256|||<|0.0001|TWO_SIDED|95.0|0.191|0.313|||Chi-squared|2x2 chi-square test||The DAS28 low disease activity response rate for adalimumab was expected to be at least 27% at Week 12.||0.313|0.191|<0.0001
72396364|NCT02618434|144298899|SUPERIORITY||Odds Ratio (OR)|0.89||||0.6635|TWO_SIDED|95.0|0.52|1.51|||Regression, Logistic|||This analysis pertains to ≥ 50% Responders.||1.51|0.52|0.6635
72396365|NCT01988103|144298900|SUPERIORITY_OR_OTHER_LEGACY||Difference|16.4||||0.0032|TWO_SIDED|95.0|5.8|27.0|||Chi-squared|||||27.0|5.8|0.0032
72396366|NCT01988103|144298900|SUPERIORITY_OR_OTHER_LEGACY||Difference|21.1||||0.0003|TWO_SIDED|95.0|10.1|32.1|||Chi-squared|||||32.1|10.1|0.0003
72396367|NCT01988103|144298901|SUPERIORITY_OR_OTHER_LEGACY||Difference|15.1||||0.0165|TWO_SIDED|95.0|3.1|27.1|||Chi-squared|||||27.1|3.1|0.0165
72396368|NCT01988103|144298901|SUPERIORITY_OR_OTHER_LEGACY||Difference|20.8||||0.002|TWO_SIDED|95.0|8.2|33.3|||Chi-squared||Missing values were imputed using the LOCF method.|||33.3|8.2|0.0020
72396369|NCT01988103|144298902|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-29.1||||0.0003|TWO_SIDED|95.0|-44.5|-13.6|||ANCOVA||2-sided 95% CI and p-values were based on an analysis of covariance model with treatment arm as a factor and baseline value as a covariate. Means (LS Means) and p-values were adjusted by covariate.|||-13.6|-44.5|0.0003
72396370|NCT01988103|144298902|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-38.0|||<|0.0001|TWO_SIDED|95.0|-53.4|-22.6|||ANCOVA||2-sided 95% CI and p-values were based on an analysis of covariance model with treatment arm as a factor and baseline value as a covariate. Means (LS Means) and p-values were adjusted by covariate.|||-22.6|-53.4|<0.0001
72396371|NCT01988103|144298903|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-29.5||||0.0002|TWO_SIDED|95.0|-44.9|-14.0|||ANCOVA||2-sided 95% CI and p-values were based on an analysis of covariance model with treatment arm as a factor and baseline value as a covariate. Means (LS Means) and p-values were adjusted by covariate.|||-14.0|-44.9|0.0002
72396372|NCT01988103|144298903|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-39.5|||<|0.0001|TWO_SIDED|95.0|-54.9|-24.1|||ANCOVA||2-sided 95% CI and p-values were based on an analysis of covariance model with treatment arm as a factor and baseline value as a covariate. Means (LS Means) and p-values were adjusted by covariate.|||-24.1|-54.9|<0.0001
72396373|NCT01988103|144298904|SUPERIORITY_OR_OTHER_LEGACY||Difference|19.7||||0.0057|TWO_SIDED|95.0|6.1|33.4|||Chi-squared|||||33.4|6.1|0.0057
72396374|NCT01988103|144298904|SUPERIORITY_OR_OTHER_LEGACY||Difference|29.2|||<|0.0001|TWO_SIDED|95.0|15.4|42.9|||Chi-squared|||||42.9|15.4|<0.0001
72396375|NCT01988103|144298905|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-14.6||||0.0003|TWO_SIDED|95.0|-22.6|-6.7|||ANCOVA||2-sided 95% CI and p-values were based on an analysis of covariance model with treatment arm as a factor and baseline value as a covariate. Means (LS Means) and p-values were adjusted by covariate.|||-6.7|-22.6|0.0003
72396376|NCT01988103|144298905|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-24.8|||<|0.0001|TWO_SIDED|95.0|-32.7|-16.9|||ANCOVA||2-sided 95% CI and p-values were based on an analysis of covariance model with treatment arm as a factor and baseline value as a covariate. Means (LS Means) and p-values were adjusted by covariate. Missing values were imputed using the LOCF method.|||-16.9|-32.7|<0.0001
72396377|NCT01988103|144298906|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.7||||0.0204|TWO_SIDED|95.0|-3.2|-0.3|||ANCOVA||2-sided 95% CI and p-values were based on an analysis of covariance model with treatment arm as a factor and baseline value as a covariate. Means (LS Means) and p-values were adjusted by covariate.|||-0.3|-3.2|0.0204
72396378|NCT01988103|144298906|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.5|||<|0.0001|TWO_SIDED|95.0|-4.9|-2.0|||ANCOVA||2-sided 95% CI and p-values were based on an analysis of covariance model with treatment arm as a factor and baseline value as a covariate. Means (LS Means) and p-values were adjusted by covariate.|||-2.0|-4.9|<0.0001
72396379|NCT01988103|144298907|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.88||||0.5149|TWO_SIDED|95.0|-1.78|3.53|||ANCOVA||2-sided 95% CI and p-values were based on an analysis of covariance model with treatment arm as a factor and baseline value as a covariate. Means (LS Means) and p-values were adjusted by covariate.|||3.53|-1.78|0.5149
72396380|NCT01988103|144298907|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.85||||0.1693|TWO_SIDED|95.0|-0.79|4.5|||ANCOVA||2-sided 95% CI and p-values were based on an analysis of covariance model with treatment arm as a factor and baseline value as a covariate. Means (LS Means) and p-values were adjusted by covariate.|||4.50|-0.79|0.1693
72396381|NCT03590041|144298913|SUPERIORITY|||||||0.04||||||Linear Mixed Model adjusted for a priori patient covariates: Race/Ethnicity, Gender, Health Literacy, Food Availability, Charlson Score, Mental Illness, Substance use. Adjusted P-value represents the significance test for the time x group interaction|Mixed Models Analysis|||We hypothesized that patients in Patient-Driven SMAs would have greater reductions in Diabetes Distress than those in Standardized SMAs. We expected seeing an effect size of a .6 unit decrease (.30) in Standardized SMAs and 1.2 unit decrease (.60) in Patient-Driven SMAs. We estimate we have \>80% power to detect effect sizes between .29 (ICC=3%) and .34 (ICC=5%).||||0.04
72396382|NCT03590041|144298914|SUPERIORITY|||||||0.82||||||Linear Mixed Model adjusted for a priori patient covariates: Race/Ethnicity, Gender, Health Literacy, Food Availability, Charlson Score, Mental Illness, Substance use. Adjusted P-value represents the significance test for the time x group interaction|Mixed Models Analysis|||We hypothesized that patients in the Patient-Driven condition would have a greater reduction in HbA1c than patients in the Standardized condition. We estimate we have \>80% power to detect effect sizes between .29 (ICC=3%) and .34 (ICC=5%).||||0.82
72396383|NCT03070782|144298922|SUPERIORITY||Mean Difference in % CFB|-31.0||||0.0032|TWO_SIDED|95.0|-46.0|-12.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in least square mean (LSM) of log (Primary Analysis Time Point/Baseline) was estimated.|||-12|-46|0.0032
72396384|NCT03070782|144298922|SUPERIORITY||Mean Difference in % CFB|-54.0|||<|0.0001|TWO_SIDED|95.0|-64.0|-41.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|||-41|-64|<.0001
72396385|NCT03070782|144298922|SUPERIORITY||Mean Difference in % CFB|-70.0|||<|0.0001|TWO_SIDED|95.0|-77.0|-62.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|||-62|-77|<.0001
72396386|NCT03070782|144298922|SUPERIORITY||Mean Difference in % CFB|-56.0|||<|0.0001|TWO_SIDED|95.0|-65.0|-43.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|||-43|-65|<.0001
72396387|NCT03070782|144298922|SUPERIORITY||Mean Difference in % CFB|-78.0|||<|0.0001|TWO_SIDED|95.0|-83.0|-72.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|||-72|-83|<.0001
72396388|NCT03070782|144298926|SUPERIORITY||Mean Difference in % CFB|-6.0||||0.4407|TWO_SIDED|95.0|-19.0|9.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|||9|-19|0.4407
72396389|NCT03070782|144298926|SUPERIORITY||Mean Difference in % CFB|-25.0|||<|0.0001|TWO_SIDED|95.0|-35.0|-13.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|||-13|-35|<.0001
72396390|NCT03070782|144298926|SUPERIORITY||Mean Difference in % CFB|-14.0||||0.0368|TWO_SIDED|95.0|-26.0|-1.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|||-1|-26|0.0368
72396391|NCT03070782|144298926|SUPERIORITY||Mean Difference in % CFB|-16.0||||0.0216|TWO_SIDED|95.0|-28.0|-3.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|||-3|-28|0.0216
72396392|NCT03070782|144298926|SUPERIORITY||Mean Difference in % CFB|-22.0||||0.0012|TWO_SIDED|95.0|-33.0|-9.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|||-9|-33|0.0012
72396393|NCT03070782|144298927|SUPERIORITY||Odds Ratio (OR)|4.98||||0.0286|TWO_SIDED|95.0|1.2|21.0|||Regression, Logistic|||||21.0|1.2|0.0286
72396394|NCT03070782|144298927|SUPERIORITY||Odds Ratio (OR)|31.07|||<|0.0001|TWO_SIDED|95.0|7.3|131.4|||Regression, Logistic|||||131.4|7.3|<.0001
72396395|NCT03070782|144298927|SUPERIORITY||Odds Ratio (OR)|122.81|||<|0.0001|TWO_SIDED|95.0|24.0|627.4|||Regression, Logistic|||||627.4|24.0|<.0001
72622919|NCT02796651|144775946|SUPERIORITY||LSMean difference|-0.016||||0.403|TWO_SIDED|95.0|-0.053|0.022|||Mixed Models Analysis|||||0.022|-0.053|0.403
72396396|NCT03070782|144298927|SUPERIORITY||Odds Ratio (OR)|43.78|||<|0.0001|TWO_SIDED|95.0|9.8|195.0|||Regression, Logistic|||||195.0|9.8|<.0001
72396397|NCT03070782|144298927|SUPERIORITY||Odds Ratio (OR)|1124.56|||<|0.0001|TWO_SIDED|95.0|109.3|11571.0|||Regression, Logistic|||||11571|109.3|<.0001
72396398|NCT03070782|144298928|SUPERIORITY||Odds Ratio (OR)|7.34||||0.2007|TWO_SIDED|95.0|0.3|155.3|||Regression, Logistic|||||155.3|0.3|0.2007
72396399|NCT03070782|144298928|SUPERIORITY||Odds Ratio (OR)|27.92||||0.0258|TWO_SIDED|95.0|1.5|521.5|||Regression, Logistic|||||521.5|1.5|0.0258
72396400|NCT03070782|144298928|SUPERIORITY||Odds Ratio (OR)|113.92||||0.0014|TWO_SIDED|95.0|6.2|2098.5|||Regression, Logistic|||||2098.5|6.2|0.0014
72396401|NCT03070782|144298928|SUPERIORITY||Odds Ratio (OR)|59.85||||0.0063|TWO_SIDED|95.0|3.2|1128.0|||Regression, Logistic|||||1128.0|3.2|0.0063
72396402|NCT03070782|144298928|SUPERIORITY||Odds Ratio (OR)|347.02|||<|0.0001|TWO_SIDED|95.0|18.3|6597.9|||Regression, Logistic|||||6597.9|18.3|<.0001
72396403|NCT03070782|144298929|SUPERIORITY||Mean Difference in % CFB|-4.0||||0.4022|TWO_SIDED|95.0|-12.0|5.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|||5|-12|0.4022
72505954|NCT02760407|144543421|NON_INFERIORITY|Non-Inferiority for each OKZ dosing regimen versus Adalimumab is achieved if the lower limit of the 97.5% confidence interval is greater than the protocol defined noninferiority margin of -7.5%.|Risk Difference (RD)|0.076|||||TWO_SIDED|97.5|0.004|0.147||||||A noninferiority margin of 7.5% was used for the comparison between OKZ and adalimumab with respect to this endpoint.||0.147|0.004|
72505955|NCT02760407|144543421|NON_INFERIORITY|Non-Inferiority for each OKZ dosing regimen versus Adalimumab is achieved if the lower limit of the 97.5% confidence interval is greater than the protocol defined noninferiority margin of -7.5%.|Risk Difference (RD)|0.069|||||TWO_SIDED|97.5|-0.003|0.141||||||A noninferiority margin of 7.5% was used for the comparison between OKZ and adalimumab with respect to this endpoint.||0.141|-0.003|
72505956|NCT02760407|144543422|SUPERIORITY||Least Squares Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.046|<|0.0001|TWO_SIDED|97.5|-0.29|-0.09|||ANCOVA|||||-0.09|-0.29|<0.0001
72505957|NCT02760407|144543422|SUPERIORITY||Least Squares Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.046|<|0.0001|TWO_SIDED|97.5|-0.33|-0.12|||ANCOVA|||||-0.12|-0.33|<0.0001
72505958|NCT02760407|144543422|OTHER||Least Squares Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.046|||TWO_SIDED|95.0|-0.28|-0.1||||||||-0.10|-0.28|
72505959|NCT02760407|144543423|SUPERIORITY||Risk Difference (RD)|0.275|||<|0.0001|TWO_SIDED|97.5|0.192|0.349|||Chi-squared|2x2 chi-square test||||0.349|0.192|<0.0001
72396404|NCT03070782|144298929|SUPERIORITY||Mean Difference in % CFB|-16.0|||<|0.0001|TWO_SIDED|95.0|-23.0|-9.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|||-9|-23|<.0001
72505960|NCT02760407|144543423|SUPERIORITY||Risk Difference (RD)|0.278|||<|0.0001|TWO_SIDED|97.5|0.195|0.353|||Chi-squared|2x2 chi-square test||||0.353|0.195|<0.0001
72505961|NCT02760407|144543423|OTHER||Risk Difference (RD)|0.237|||||TWO_SIDED|95.0|0.165|0.303||||||||0.303|0.165|
72505962|NCT02760407|144543424|SUPERIORITY||Risk Difference (RD)|0.08||||0.0003|TWO_SIDED|97.5|0.031|0.123|||Chi-squared|2x2 chi-square test||||0.123|0.031|0.0003
72565692|NCT02709486|144662693|SUPERIORITY||Odds Ratio (OR)|2.39||||0.2121|TWO_SIDED|95.0|0.61|9.41|||Regression, Logistic|||Week 2, \>=90%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||9.41|0.61|0.2121
72565693|NCT02709486|144662693|SUPERIORITY||Odds Ratio (OR)|1.67||||0.4859|TWO_SIDED|95.0|0.39|7.11|||Regression, Logistic|||Week 2, \>=90%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||7.11|0.39|0.4859
72396405|NCT03070782|144298929|SUPERIORITY||Mean Difference in % CFB|-9.0||||0.0323|TWO_SIDED|95.0|-17.0|-1.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|||-1|-17|0.0323
72396406|NCT03070782|144298929|SUPERIORITY||Mean Difference in % CFB|-10.0||||0.0157|TWO_SIDED|95.0|-18.0|-2.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|||-2|-18|0.0157
72396407|NCT03070782|144298929|SUPERIORITY||Mean Difference in % CFB|-17.0|||<|0.0001|TWO_SIDED|95.0|-24.0|-9.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|||-9|-24|<.0001
72396408|NCT03070782|144298930|SUPERIORITY||Mean Difference in % CFB|-9.0||||0.4956|TWO_SIDED|95.0|-32.0|21.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|||21|-32|0.4956
72396409|NCT03070782|144298930|SUPERIORITY||Mean Difference in % CFB|-36.0||||0.0027|TWO_SIDED|95.0|-52.0|-14.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|||-14|-52|0.0027
72505963|NCT02760407|144543424|SUPERIORITY||Risk Difference (RD)|0.069||||0.001|TWO_SIDED|97.5|0.02|0.111|||Chi-squared|2x2 chi-square test||||0.111|0.020|0.001
72505964|NCT02760407|144543424|OTHER||Risk Difference (RD)|0.089|||||TWO_SIDED|95.0|0.046|0.127||||||||0.127|0.046|
72505965|NCT01748760|144543437|SUPERIORITY_OR_OTHER|||||||0.87|TWO_SIDED||||||Chi-squared|||||||.87
72505966|NCT03245814|144543438|SUPERIORITY||Odds Ratio (OR)|0.22|||<|0.001|TWO_SIDED|95.0|0.12|0.42|||Ordinal cumulative probability model|Covariates included baseline score \& demographic/clinical characteristics. Multiple imputation was used to account for uncertainty (missingness).||||0.42|0.12|<.001
72505967|NCT03245814|144543439|SUPERIORITY||Odds Ratio (OR)|0.21|||<|0.001|TWO_SIDED|95.0|0.11|0.4|||Ordinal cumulative probability model|Covariates included baseline scores \& demographic/clinical characteristics. Multiple imputation was used to account for uncertainty (missingness).||||0.40|0.11|<.001
72505968|NCT03245814|144543440|SUPERIORITY||Odds Ratio (OR)|0.45||||0.02|TWO_SIDED|95.0|0.23|0.86|||Ordinal cumulative probability model|Covariates included baseline scores \& demographic/clinical characteristics. Multiple imputation was used to account for uncertainty (missingness).||||0.86|0.23|.02
72505969|NCT03245814|144543441|SUPERIORITY||Odds Ratio (OR)|0.25|||<|0.001|TWO_SIDED|95.0|0.13|0.5|||Ordinal cumulative probability model|Covariates included baseline scores \& demographic/clinical characteristics. Multiple imputation was used to account for uncertainty (missingness).||||0.50|0.13|<.001
72505970|NCT03245814|144543442|SUPERIORITY||Odds Ratio (OR)|0.34||||0.001|TWO_SIDED|95.0|0.18|0.64|||Ordinal cumulative probability model|Covariates included baseline scores \& demographic/clinical characteristics. Multiple imputation was used to account for uncertainty (missingness).||||0.64|0.18|.001
72565694|NCT02709486|144662693|SUPERIORITY||Odds Ratio (OR)|2.25|||<|0.0001|TWO_SIDED|95.0|1.6|3.17|||Regression, Logistic|||Week 4, \>=30%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.17|1.60|<.0001
72396410|NCT03070782|144298930|SUPERIORITY||Mean Difference in % CFB|-54.0|||<|0.0001|TWO_SIDED|95.0|-65.0|-38.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|||-38|-65|<.0001
72396411|NCT03070782|144298930|SUPERIORITY||Mean Difference in % CFB|-31.0||||0.0114|TWO_SIDED|95.0|-48.0|-8.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|||-8|-48|0.0114
72396412|NCT03070782|144298930|SUPERIORITY||Mean Difference in % CFB|-62.0|||<|0.0001|TWO_SIDED|95.0|-72.0|-49.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|||-49|-72|<.0001
72396413|NCT03070782|144298931|SUPERIORITY||Mean Difference in % CFB|-45.0||||0.002|TWO_SIDED|95.0|-62.0|-19.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|||-19|-62|0.0020
72471624|NCT00474526|144466761|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA3 over LA4, the lower limit of two-sided 95% CI for the ratio of pertussis GMCs (GMCLA3 / GMCLA4) must be greater than 0.67; the lower limit of the two-sided 95% CI for the ratio of GMCs (GMCLA3 / GMCLA4) or GMTs (poliovirus antigens) for the other antigens must be greater than 0.50.|Ratio of GMTs|0.81|||||TWO_SIDED|95.0|0.59|1.11|||ANOVA|||Polio Type 3 (Post-vaccination GMT; group ratio LA3:LA4)||1.11|0.59|
72471625|NCT00474526|144466761|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA3 over LA4, the lower limit of two-sided 95% CI for the ratio of pertussis GMCs (GMCLA3 / GMCLA4) must be greater than 0.67; the lower limit of the two-sided 95% CI for the ratio of GMCs (GMCLA3 / GMCLA4) or GMTs (poliovirus antigens) for the other antigens must be greater than 0.50.|Ratio of GMTs|0.95|||||TWO_SIDED|95.0|0.76|1.19|||ANOVA|||Hepatitis B (Post-vaccination GMT; group ratio LA3:LA4)||1.19|0.76|
72471626|NCT00474526|144466761|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA3 over LA4, the lower limit of two-sided 95% CI for the ratio of pertussis GMCs (GMCLA3 / GMCLA4) must be greater than 0.67; the lower limit of the two-sided 95% CI for the ratio of GMCs (GMCLA3 / GMCLA4) or GMTs (poliovirus antigens) for the other antigens must be greater than 0.50.|Ratio of GMCs|1.07|||||TWO_SIDED|95.0|0.83|1.37|||ANOVA|||HIb (Post-vaccination GMC; group ratio LA3:LA4)||1.37|0.83|
72471627|NCT00474526|144466761|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA3 over LA4, the lower limit of two-sided 95% CI for the ratio of pertussis GMCs (GMCLA3 / GMCLA4) must be greater than 0.67; the lower limit of the two-sided 95% CI for the ratio of GMCs (GMCLA3 / GMCLA4) or GMTs (poliovirus antigens) for the other antigens must be greater than 0.50.|Ratio of GMTs|0.8|||||TWO_SIDED|95.0|0.68|0.95|||ANOVA|||PnC 4 (Post-vaccination GMT; group ratio LA3:LA4)||0.95|0.68|
72471628|NCT00474526|144466761|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA3 over LA4, the lower limit of two-sided 95% CI for the ratio of pertussis GMCs (GMCLA3 / GMCLA4) must be greater than 0.67; the lower limit of the two-sided 95% CI for the ratio of GMCs (GMCLA3 / GMCLA4) or GMTs (poliovirus antigens) for the other antigens must be greater than 0.50.|Ratio of GMCs|0.87|||||TWO_SIDED|95.0|0.67|1.14|||ANOVA|||PnC 6B (Post-vaccination GMC; group ratio LA3:LA4)||1.14|0.67|
72396414|NCT03070782|144298931|SUPERIORITY||Mean Difference in % CFB|-63.0|||<|0.0001|TWO_SIDED|95.0|-74.0|-46.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|||-46|-74|<.0001
72505971|NCT03245814|144543443|SUPERIORITY||Odds Ratio (OR)|2.83||||0.003|TWO_SIDED|95.0|1.47|5.45|||Ordinal cumulative probability model|Covariates included baseline scores \& demographic/clinical characteristics. Multiple imputation was used to account for uncertainty (missingness).||||5.45|1.47|.003
72396415|NCT03070782|144298931|SUPERIORITY||Mean Difference in % CFB|-82.0|||<|0.0001|TWO_SIDED|95.0|-87.0|-73.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|||-73|-87|<.0001
72396416|NCT03070782|144298931|SUPERIORITY||Mean Difference in % CFB|-68.0|||<|0.0001|TWO_SIDED|95.0|-78.0|-54.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|||-54|-78|<.0001
72396417|NCT03070782|144298931|SUPERIORITY||Mean Difference in % CFB|-89.0|||<|0.0001|TWO_SIDED|95.0|-93.0|-84.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|||-84|-93|<.0001
72396418|NCT00558025|144298952|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin: -15 %, power: 80%|Risk Difference (RD)|-10.75||||||95.0|-20.51|1.48|||Wilson score interval|||Successfully switched patients||1.48|-20.51|
72396419|NCT00558025|144298952|SUPERIORITY_OR_OTHER|||||||0.0803||95.0|||||Cochran-Mantel-Haenszel|test with stratification by country||||||0.0803
72396420|NCT00558025|144298953|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.1||||0.2061||95.0|-2.8|0.6|||ANCOVA|ANCOVA with factors of treatment, country and baseline as covariate||||0.6|-2.8|0.2061
72396421|NCT00558025|144298954|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2||||0.4694||95.0|-0.8|0.4|||ANCOVA|ANCOVA with factors of treatment, country and baseline as covariate||||0.4|-0.8|0.4694
72396422|NCT00558025|144298955|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9||||0.1804||95.0|-2.3|0.4|||ANCOVA|ANCOVA with factors of treatment, country and baseline as covariate||||0.4|-2.3|0.1804
72396423|NCT00558025|144298956|SUPERIORITY_OR_OTHER|||||||0.1623|||||||Cochran-Mantel-Haenszel|test with stratification by country||||||0.1623
72396424|NCT00558025|144298957|SUPERIORITY_OR_OTHER|||||||0.1299|||||||Cochran-Mantel-Haenszel|test with stratification by country||||||0.1299
72396425|NCT00558025|144298958|SUPERIORITY_OR_OTHER|||||||0.619||95.0|||||Cochran-Mantel-Haenszel|test with stratification by country||||||0.6190
72396426|NCT02135146|144298960|SUPERIORITY|||||||0.31|||||||t-test, 2 sided|||||||0.31
72396427|NCT02135146|144298960|SUPERIORITY|||||||0.07|||||||t-test, 2 sided|||||||0.07
72471629|NCT00474526|144466761|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA3 over LA4, the lower limit of two-sided 95% CI for the ratio of pertussis GMCs (GMCLA3 / GMCLA4) must be greater than 0.67; the lower limit of the two-sided 95% CI for the ratio of GMCs (GMCLA3 / GMCLA4) or GMTs (poliovirus antigens) for the other antigens must be greater than 0.50.|Ratio of GMCs|0.83|||||TWO_SIDED|95.0|0.69|1.0|||ANOVA|||PnC 9V (Post-vaccination GMC; group ratio LA3:LA4)||1|0.69|
72505972|NCT03245814|144543444|SUPERIORITY||Odds Ratio (OR)|0.24|||<|0.001|TWO_SIDED|95.0|0.12|0.48|||Ordinal cumulative probability model|Covariates included baseline scores \& demographic/clinical characteristics. Multiple imputation was used to account for uncertainty (missingness).||||0.48|0.12|<.001
72622920|NCT02796651|144775946|SUPERIORITY||LSMean difference|0.035||||0.074|TWO_SIDED|95.0|-0.003|0.074|||Mixed Models Analysis|||||0.074|-0.003|0.074
72396428|NCT03315208|144298967|SUPERIORITY||Chi-squared statistic value|0.23||||0.63|TWO_SIDED||||||Chi-squared, Corrected|df=1||||||0.63
72505973|NCT03245814|144543445|SUPERIORITY||Odds Ratio (OR)|3.84|||<|0.001|TWO_SIDED|95.0|2.0|7.38|||Ordinal cumulative probability model|Covariates included baseline scores \& demographic/clinical characteristics. Multiple imputation was used to account for uncertainty (missingness).||||7.38|2.00|<.001
72505974|NCT03245814|144543446|SUPERIORITY||Odds Ratio (OR)|4.49|||<|0.001|TWO_SIDED|95.0|2.28|8.83|||Ordinal cumulative probability model|Covariates included baseline scores \& demographic/clinical characteristics. Multiple imputation was used to account for uncertainty (missingness).||||8.83|2.28|<.001
72505975|NCT03245814|144543447|SUPERIORITY||Odds Ratio (OR)|3.73|||<|0.001|TWO_SIDED|95.0|1.88|7.4|||Ordinal cumulative probability model|Covariates included baseline scores \& demographic/clinical characteristics. Multiple imputation was used to account for uncertainty (missingness).||||7.40|1.88|<.001
72505976|NCT03245814|144543448|SUPERIORITY||Odds Ratio (OR)|2.33||||0.02|TWO_SIDED|95.0|1.22|4.47|||Ordinal cumulative probability model|Covariates included baseline scores \& demographic/clinical characteristics. Multiple imputation was used to account for uncertainty (missingness).||||4.47|1.22|.02
72505977|NCT03245814|144543449|SUPERIORITY||Odds Ratio (OR)|0.39||||0.009|TWO_SIDED|95.0|0.2|0.75|||Ordinal cumulative probability model|Covariates included baseline scores \& demographic/clinical characteristics. Multiple imputation was used to account for uncertainty (missingness).||||0.75|0.20|.009
72505978|NCT03245814|144543450|SUPERIORITY||Slope|0.42|STANDARD_ERROR_OF_MEAN|0.14||0.002|TWO_SIDED||||||Mixed Models Analysis|Mixed effects regression models to account for repeated measures (multiple assessments per day) within individuals.||||||0.002
72505979|NCT02522377|144543459|SUPERIORITY|Superiority test based upon group differences pooled across infusions|Mean Difference (Final Values)|1.22|STANDARD_ERROR_OF_MEAN|3.28||0.72|TWO_SIDED||||||Mixed Models Analysis|Model includes main effect for treatment group and infusion number categorically. Satterthwaite DF=9.987.|Midazolam - Ketamine Infusions|||||0.72
72505980|NCT02522377|144543460|SUPERIORITY|Superiority test based upon group differences pooled across infusions in mixed effect model|Mean Difference (Final Values)|1.98|STANDARD_ERROR_OF_MEAN|6.4||0.77|TWO_SIDED||||||Mixed Models Analysis|Model includes main effect for treatment group and infusion number categorically. Satterthwaite DF=7.836.|Midazolam - Ketamine Infusions|||||0.77
72505981|NCT02522377|144543461|SUPERIORITY|Superiority test based upon group differences pooled across infusions|Mean Difference (Final Values)|0.98|STANDARD_ERROR_OF_MEAN|1.12||0.4|TWO_SIDED||||||Mixed Models Analysis|Model includes main effect for treatment group and infusion number categorically. Satterthwaite DF=9.987.|Midazolam - Ketamine Infusions|||||0.40
72505982|NCT02522377|144543462|SUPERIORITY|Superiority test based upon group differences pooled across infusions|Mean Difference (Final Values)|1.78|STANDARD_ERROR_OF_MEAN|0.54||0.009|TWO_SIDED||||||Mixed Models Analysis|Model includes main effect for treatment group and infusion number categorically. Satterthwaite DF=9.3634.|Midazolam - Ketamine Infusions|||||0.009
72505983|NCT02522377|144543463|SUPERIORITY|Superiority test based upon group differences pooled across infusions|Mean Difference (Final Values)|3.72|STANDARD_ERROR_OF_MEAN|3.71||0.34|TWO_SIDED||||||Mixed Models Analysis|Model includes main effect for treatment group and infusion number categorically. Satterthwaite DF=9.987.|Midazolam - Ketamine Infusions|||||0.34
72505984|NCT02522377|144543464|SUPERIORITY||Odds Ratio (OR)|0.36||||0.58|TWO_SIDED|95.0|0.01|7.2|||Fisher Exact||Odds Ratio of Midazolam (numerator) to Ketamine Infusions (denominator)|||7.20|0.01|0.58
72505985|NCT01158950|144543465|SUPERIORITY|||||||0.032||||||The threshold for statistical significance was set to p \< 0.05.|Fisher transformation|||The comparison group represents the difference in ICR and the baseline impulsiveness scale.||||0.032
72396429|NCT03315208|144298968|SUPERIORITY||Slope|0.72||||0.29|TWO_SIDED|||||p-value is for the model parameter of the condition-by-time interaction term.|Mixed Models Analysis||The treatment condition effect was determined by the model parameter of the condition-by-time interaction term.|Linear mixed effects models with random intercepts (as best practice likelihood ratio tests dropping random slopes and intercepts indicated that only random intercepts should be retained) were used, with restricted maximum likelihood estimation (REML) for missing data. Analyses were intent-to-treat so included all randomized participants (n=29 in the UP+TAU group and n=18 in the TAU alone group), regardless of whether or not they completed the mid- or post-treatment assessments.||||0.29
72505986|NCT01158950|144543466|SUPERIORITY||||||<|0.05||||||The threshold is set to p \< 0.05, corrected for multiple comparisons.|Fisher transformation|Statistical tests are computed across multiple subregions (voxels) within each area. Thus, the correlation coefficient above is a summary score.||||||< 0.05
72505987|NCT02179398|144543487|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED|95.0|||||Chi-squared|||||||1
72505988|NCT02179398|144543488|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED|95.0|||||Chi-squared|||||||1
72505989|NCT02179398|144543489|SUPERIORITY_OR_OTHER|||||||0.81|TWO_SIDED|95.0|||||Chi-squared|||Power calculation suggested 97 patients should be enrolled in each group to give 80% power at the 5% level of significance to detect a 20% difference in antibiotic prescription rate||||0.810
72505990|NCT02519231|144543569|SUPERIORITY||Mean Difference (Net)|-1.76|STANDARD_ERROR_OF_MEAN|5.0||0.11|TWO_SIDED|95.0||||The threshold for statistical significance was p =0.05|t-test, 2 sided|For days with bleeding/spotting outcomes, we used independent t-tests to compare the unadjusted mean difference between groups.|Treatment Difference = Naproxen - Placebo|We originally planned to enroll 60 subjects based on other similar studies that evaluated treatment for bleeding among women using contraception; as reported by Cohen et al., a sample size of 42 provided 80% power to detect a difference of 7 bleeding/spotting days in 30 days by two-sample t-test, allowing for an expected 20% drop-out.|We designed the study to include another site, in addition to the UW site enrolled participants. After 6 months of failed active recruitment at the other site, we discontinued that site from the study. Resources did not permit us to contract with an alternative recruitment site, and thus the protocol was revised to enroll 32 participants at the Seattle site only.|||.11
72505991|NCT02519231|144543570|SUPERIORITY||||||<|0.05|||||||Chi-squared|||||||<0.05
72622921|NCT02796651|144775946|SUPERIORITY||LSMean difference|-0.006||||0.75|TWO_SIDED|95.0|-0.045|0.032|||Mixed Models Analysis|||||0.032|-0.045|0.750
72622922|NCT02796651|144775946|SUPERIORITY||LSMean difference|-0.041||||0.035|TWO_SIDED|95.0|-0.08|-0.003|||Mixed Models Analysis|||||-0.003|-0.080|0.035
72396430|NCT03315208|144298969|SUPERIORITY||Slope|-0.56||||0.5|TWO_SIDED|||||p-value is for the model parameter of the condition-by-time interaction term.|Mixed Models Analysis||The treatment condition effect was determined by the model parameter of the condition-by-time interaction term.|Linear mixed effects models with random intercepts (as best practice likelihood ratio tests dropping random slopes and intercepts indicated that only random intercepts should be retained) were used, with restricted maximum likelihood estimation (REML) for missing data. Analyses were intent-to-treat so included all randomized participants (n=29 in the UP+TAU group and n=18 in the TAU alone group), regardless of whether or not they completed the mid- or post-treatment assessments.||||.50
72396431|NCT03315208|144298970|SUPERIORITY||Slope|-1.96||||0.45|TWO_SIDED|||||p-value is for the model parameter of the condition-by-time interaction term.|Mixed Models Analysis||The treatment condition effect was determined by the model parameter of the condition-by-time interaction term. BSI scores were binarized (0 and \>=1) for this analysis due to the non-normal distribution of this outcome.|Linear mixed effects models with random intercepts (as best practice likelihood ratio tests dropping random slopes and intercepts indicated that only random intercepts should be retained) were used, with restricted maximum likelihood estimation (REML) for missing data. Analyses were intent-to-treat so included all randomized participants (n=29 in the UP+TAU group and n=18 in the TAU alone group), regardless of whether or not they completed the mid- or post-treatment assessments.||||0.45
72396432|NCT03315208|144298972|SUPERIORITY||Slope|-0.19||||0.76|TWO_SIDED|||||p-value is for the model parameter of the condition-by-time interaction term.|Mixed Models Analysis||The treatment condition effect was determined by the model parameter of the condition-by-time interaction term.|Linear mixed effects models with random intercepts (as best practice likelihood ratio tests dropping random slopes and intercepts indicated that only random intercepts should be retained) were used, with restricted maximum likelihood estimation (REML) for missing data. Analyses were intent-to-treat so included all randomized participants (n=29 in the UP+TAU group and n=18 in the TAU alone group), regardless of whether or not they completed the mid- or post-treatment assessments.||||0.76
72396433|NCT03315208|144298973|SUPERIORITY||Slope|-1.07||||0.21|TWO_SIDED|||||p-value is for the model parameter of the condition-by-time interaction term.|Mixed Models Analysis||The treatment condition effect was determined by the model parameter of the condition-by-time interaction term. Due to the non-normal distribution of the Craving Scale, scores on this measure were binarized (\< 15 and \>= 15) for this analysis.|Linear mixed effects models with random intercepts (as best practice likelihood ratio tests dropping random slopes and intercepts indicated that only random intercepts should be retained) were used, with restricted maximum likelihood estimation (REML) for missing data. Analyses were intent-to-treat so included all randomized participants (n=29 in the UP+TAU group and n=18 in the TAU alone group), regardless of whether or not they completed the mid- or post-treatment assessments.||||.21
72396434|NCT03315208|144298974|SUPERIORITY||t statistic|0.29||||0.77|TWO_SIDED||||||t-test, 2 sided|||Due to the non-normal distribution of the PDA variable, this variable was treated as binary (\<50% and \>=50%) for mixed models; however, due to the small numbers of participants (\< 5) in certain cells of treatment condition (UP versus TAU) by time point, we ran into issues with convergence of linear mixed models. Thus, here we report the results from an independent samples t-test of means (percentage of past 30 days abstinent) at post-treatment (UP versus TAU).||||0.77
72396435|NCT02746874|144298983|SUPERIORITY|||||||0.978|||||||Wilcoxon (Mann-Whitney)|||||||.978
72396436|NCT02746874|144298985|SUPERIORITY|||||||0.978|||||||Wilcoxon (Mann-Whitney)|||||||.978
72396437|NCT02746874|144298986|SUPERIORITY|||||||0.371|||||||t-test, 2 sided|||||||.371
72396438|NCT02746874|144298987|SUPERIORITY|||||||0.325|||||||t-test, 2 sided|||||||.325
72396439|NCT02746874|144298988|SUPERIORITY|||||||0.466|||||||t-test, 2 sided|||||||.466
72396440|NCT02746874|144298989|SUPERIORITY|||||||0.368|||||||Wilcoxon (Mann-Whitney)|||||||.368
72396441|NCT02746874|144298990|SUPERIORITY|||||||0.509|||||||Wilcoxon (Mann-Whitney)|||||||.509
72396442|NCT02746874|144298991|SUPERIORITY|||||||0.593|||||||Wilcoxon (Mann-Whitney)|||||||.593
72396443|NCT02746874|144298992|SUPERIORITY|||||||0.687|||||||Wilcoxon (Mann-Whitney)|||||||0.687
72396444|NCT02746874|144298993|SUPERIORITY|||||||0.813|||||||Wilcoxon (Mann-Whitney)|||||||.813
72396445|NCT02746874|144298994|SUPERIORITY|||||||0.687|||||||Wilcoxon (Mann-Whitney)|||||||.687
72396446|NCT02746874|144298995|SUPERIORITY|||||||0.84|||||||Wilcoxon (Mann-Whitney)|||||||0.840
72396447|NCT02746874|144298996|SUPERIORITY|||||||0.913|||||||Wilcoxon (Mann-Whitney)|||||||.913
72396448|NCT02746874|144298997|SUPERIORITY|||||||0.301|||||||Wilcoxon (Mann-Whitney)|||||||0.301
72396449|NCT02746874|144298998|SUPERIORITY|||||||0.826|||||||Wilcoxon (Mann-Whitney)|||||||0.826
72396450|NCT02746874|144298999|SUPERIORITY|||||||0.813|||||||Wilcoxon (Mann-Whitney)|||||||.813
72396451|NCT02746874|144299001|SUPERIORITY|||||||0.047|||||||Wilcoxon (Mann-Whitney)|||||||.047
72396452|NCT02746874|144299002|SUPERIORITY|||||||0.115|||||||Wilcoxon (Mann-Whitney)|||||||.115
72396453|NCT02746874|144299003|SUPERIORITY|||||||0.349|||||||Wilcoxon (Mann-Whitney)|||||||.349
72396454|NCT00982592|144299014|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.03||||0.874|TWO_SIDED|95.0|0.7|1.54|||Log Rank|||||1.54|0.70|0.874
72396455|NCT00982592|144299016|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.3||||0.253|TWO_SIDED|95.0|0.83|2.05|||Log Rank|||||2.05|0.83|0.253
72396456|NCT00333866|144299029|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) mean difference|-0.23||||0.2361|TWO_SIDED|95.0|-0.61|0.15|||ANCOVA|Hochberg's approach was used to protect the Type I error rate at 0.05 level, Hochberg adjusted p-values were presented.||P value was calculated using Analysis of Covariance (ANCOVA) with treatment and center in the model, and the baseline mean pain score as covariate.||0.15|-0.61|0.2361
72396457|NCT00333866|144299029|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.56||||0.0132|TWO_SIDED|95.0|-0.94|-0.17|||ANCOVA|Hochberg's approach was used to protect the Type I error rate at 0.05 level, Hochberg adjusted p-values were presented.||P value was calculated using ANCOVA with treatment and center in the model, and the baseline mean pain score as covariate.||-0.17|-0.94|0.0132
72396458|NCT00333866|144299029|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) mean difference|-0.33||||0.1694|TWO_SIDED|95.0|-0.72|0.05|||ANCOVA|Hochberg's approach was used to protect the Type I error rate at 0.05 level, Hochberg adjusted p-values were presented.||P value was calculated using ANCOVA with treatment and center in the model, and the baseline mean pain score as covariate.||0.05|-0.72|0.1694
72396459|NCT00333866|144299030|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0227||95.0|||||Cochran-Mantel-Haenszel|||P-values less than 0.05 (2-sided) considered statistically significant. P-values were calculated using a modified ridit transformation with the Cochran-Mantel-Haenszel procedure, adjusting for center.||||0.0227
72396460|NCT00333866|144299030|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0017||95.0|||||Cochran-Mantel-Haenszel|||P-values less than 0.05 (2-sided) considered statistically significant. P-values were calculated using a modified ridit transformation with the Cochran-Mantel-Haenszel procedure, adjusting for center.||||0.0017
72396461|NCT00333866|144299030|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0768||95.0|||||Cochran-Mantel-Haenszel|||P-values less than 0.05 (2-sided) considered statistically significant. P-values were calculated using a modified ridit transformation with the Cochran-Mantel-Haenszel procedure, adjusting for center.||||0.0768
72396462|NCT00333866|144299031|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.01|||<|0.0001|TWO_SIDED|95.0|-1.42|-0.6|||ANCOVA|||P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline mean sleep score as covariate.||-0.60|-1.42|<.0001
72396463|NCT00333866|144299031|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.78||||0.0002|TWO_SIDED|95.0|-1.2|-0.37|||ANCOVA|||P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline mean sleep score as covariate.||-0.37|-1.20|0.0002
72396464|NCT00333866|144299031|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.48||||0.0222|TWO_SIDED|95.0|-0.89|-0.07|||ANCOVA|||P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline mean sleep score as covariate.||-0.07|-0.89|0.0222
72396465|NCT00333866|144299032|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.85|||<|0.0001|TWO_SIDED|95.0|-1.2|-0.5|||Mixed Model Repeated Measures ANCOVA|||Week 1: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.||-0.5|-1.2|<.0001
72396466|NCT00333866|144299032|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.7||||0.0003|TWO_SIDED|95.0|-1.1|-0.3|||Mixed Model Repeated Measures ANCOVA|||Week 1: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.||-0.3|-1.1|0.0003
72396467|NCT00333866|144299032|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.81|||<|0.0001|TWO_SIDED|95.0|-1.2|-0.4|||Mixed Model Repeated Measures ANCOVA|||Week 1: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.||-0.4|-1.2|<.0001
72396468|NCT00333866|144299032|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.97|||<|0.0001|TWO_SIDED|95.0|-1.3|-0.6|||Mixed Model Repeated Measures ANCOVA|||Week 2: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.||-0.6|-1.3|<.0001
72396469|NCT00333866|144299032|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.81|||<|0.0001|TWO_SIDED|95.0|-1.2|-0.4|||Mixed Model Repeated Measures ANCOVA|||Week 2: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.||-0.4|-1.2|<.0001
72471630|NCT00474526|144466761|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA3 over LA4, the lower limit of two-sided 95% CI for the ratio of pertussis GMCs (GMCLA3 / GMCLA4) must be greater than 0.67; the lower limit of the two-sided 95% CI for the ratio of GMCs (GMCLA3 / GMCLA4) or GMTs (poliovirus antigens) for the other antigens must be greater than 0.50.|Ratio of GMCs|0.84||||||95.0|0.67|1.05|||ANOVA|||PnC 14 (Post-vaccination GMC; group ratio LA3:LA4)||1.05|0.67|
72471631|NCT00474526|144466761|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA3 over LA4, the lower limit of two-sided 95% CI for the ratio of pertussis GMCs (GMCLA3 / GMCLA4) must be greater than 0.67; the lower limit of the two-sided 95% CI for the ratio of GMCs (GMCLA3 / GMCLA4) or GMTs (poliovirus antigens) for the other antigens must be greater than 0.50.|Ratio of GMCs|0.75|||||TWO_SIDED|95.0|0.62|0.9|||ANOVA|||PnC 18C (Post-vaccination GMC; group ratio LA3:LA4)||0.9|0.62|
72505992|NCT01707147|144543589|OTHER||Mean Difference (Final Values)|-0.77|STANDARD_DEVIATION|1.5|<|0.0001|TWO_SIDED|95.0|-0.83|-0.71|||Paired t-test||p-value of paired t-test for change from baseline is presented. 95% confidence interval for the mean was calculated using t-distribution.|||-0.71|-0.83|<0.0001
72505993|NCT01707147|144543592|OTHER||Mean Difference (Final Values)|-18.05|STANDARD_DEVIATION|61.84|<|0.0001|TWO_SIDED|95.0|-20.98|-15.12|||Paired t-test||p-value of paired t-test for change from baseline is presented. 95% confidence interval for the mean was calculated using t-distribution.|||-15.12|-20.98|<0.0001
72505994|NCT03320512|144543605|SUPERIORITY||Average Treatment Effect|0.15||||0.04965|TWO_SIDED|95.0|0.0|0.29|||TMLE estimation of ATE and Wald test|Targeted Maximum Likelihood Estimation (TMLE) Average Treatment Effect (ATE)||Month 3 The analysis includes the intent-to-treat population||0.29|0.00|0.04965
72505995|NCT03320512|144543605|SUPERIORITY||Average Treatment Effect|-0.04||||0.62|TWO_SIDED|95.0|-0.21|0.13|||TMLE estimation of ATE and Wald test|||Month 6 The analysis includes the intent-to-treat population||0.13|-0.21|0.62
72505996|NCT03320512|144543606|SUPERIORITY||Average Treatment Effect|0.12||||0.11|TWO_SIDED|95.0|-0.03|0.26|||TMLE estimation of ATE and Wald test|||Month 3 The analysis includes the intent-to-treat population||0.26|-0.03|0.11
72471632|NCT00474526|144466761|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA3 over LA4, the lower limit of two-sided 95% CI for the ratio of pertussis GMCs (GMCLA3 / GMCLA4) must be greater than 0.67; the lower limit of the two-sided 95% CI for the ratio of GMCs (GMCLA3 / GMCLA4) or GMTs (poliovirus antigens) for the other antigens must be greater than 0.50.|Ratio of GMCs|0.91|||||TWO_SIDED|95.0|0.75|1.1|||ANOVA|||PnC 19F (Post-vaccination GMC; group ratio LA3:LA4)||1.1|0.75|
72505997|NCT03320512|144543606|SUPERIORITY||Average Treatment Effect|0.06||||0.38|TWO_SIDED|95.0|-0.08|0.21|||TMLE estimation of ATE and Wald test|||Month 6 The analysis includes the intent-to-treat population||0.21|-0.08|0.38
72505998|NCT03320512|144543607|SUPERIORITY||Average Treatment Effect|0.04||||0.68|TWO_SIDED|95.0|-0.09|0.16||P-values adjusted using the Benjamini Hochberg procedure.|TMLE estimation of ATE and Wald test|||Month 3 The analysis includes the intent-to-treat population and compares P3 and P3+ vs. Control.||0.16|-0.09|0.68
72396470|NCT00333866|144299032|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.86|||<|0.0001|TWO_SIDED|95.0|-1.2|-0.5|||Mixed Model Repeated Measures ANCOVA|||Week 2: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.||-0.5|-1.2|<.0001
72396471|NCT00333866|144299032|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.15|||<|0.0001|TWO_SIDED|95.0|-1.5|-0.8|||Mixed Model Repeated Measures ANCOVA|||Week 3: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.||-0.8|-1.5|<.0001
72396472|NCT00333866|144299032|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.8|||<|0.0001|TWO_SIDED|95.0|-1.2|-0.4|||Mixed Model Repeated Measures ANCOVA|||Week 3: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.||-0.4|-1.2|<.0001
72396473|NCT00333866|144299032|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.67||||0.0005|TWO_SIDED|95.0|-1.0|-0.3|||Mixed Model Repeated Measures ANCOVA|||Week 3: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.||-0.3|-1.0|0.0005
72396474|NCT00333866|144299032|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.28|||<|0.0001||95.0|-1.7|-0.9|||Mixed Model Repeated Measures ANCOVA|||Week 4: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.||-0.9|-1.7|<.0001
72396475|NCT00333866|144299032|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.94|||<|0.0001|TWO_SIDED|95.0|-1.3|-0.6|||Mixed Model Repeated Measures ANCOVA|||Week 4: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.||-0.6|-1.3|<.0001
72396476|NCT00333866|144299032|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.8|||<|0.0001|TWO_SIDED|95.0|-1.2|-0.4|||Mixed Model Repeated Measures ANCOVA|||Week 4: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.||-0.4|-1.2|<.0001
72396477|NCT00333866|144299032|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.17|||<|0.0001|TWO_SIDED|95.0|-1.6|-0.8|||Mixed Model Repeated Measures ANCOVA|||Week 5: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.||-0.8|-1.6|<.0001
72396478|NCT00333866|144299032|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.87|||<|0.0001|TWO_SIDED|95.0|-1.3|-0.5|||Mixed Model Repeated Measures ANCOVA|||Week 5: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.||-0.5|-1.3|<.0001
72396479|NCT00333866|144299032|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.85|||<|0.0001|TWO_SIDED|95.0|-1.2|-0.5|||Mixed Model Repeated Measures ANCOVA|||Week 5: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.||-0.5|-1.2|<.0001
72396480|NCT00333866|144299032|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.31|||<|0.0001|TWO_SIDED|95.0|-1.7|-0.9|||Mixed Model Repeated Measures ANCOVA|||Week 6: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.||-0.9|-1.7|<.0001
72396481|NCT00333866|144299032|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.92|||<|0.0001|TWO_SIDED|95.0|-1.3|-0.5|||Mixed Model Repeated Measures ANCOVA|||Week 6: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.||-0.5|-1.3|<.0001
72396482|NCT00333866|144299032|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.72||||0.0003|TWO_SIDED|95.0|-1.1|-0.3|||Mixed Model Repeated Measures ANCOVA|||Week 6: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.||-0.3|-1.1|0.0003
72396483|NCT00333866|144299032|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.29|||<|0.0001|TWO_SIDED|95.0|-1.7|-0.9|||Mixed Model Repeated Measures ANCOVA|||Week 7: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.||-0.9|-1.7|<.0001
72505999|NCT03320512|144543607|SUPERIORITY||Average Treatment Effect|0.11||||0.53|TWO_SIDED|95.0|-0.03|0.25||P-values adjusted using the Benjamini Hochberg procedure.|TMLE estimation of ATE and Wald test|||Month 6 The analysis includes the intent-to-treat population and compares P3 and P3+ vs. Control.||0.25|-0.03|0.53
72506000|NCT03320512|144543608|SUPERIORITY||Average Treatment Effect|0.06||||0.53|TWO_SIDED|95.0|-0.02|0.15||P-values adjusted using the Benjamini Hochberg procedure.|TMLE estimation of ATE and Wald test|||Month 3 The analysis includes the intent-to-treat population and compares P3 and P3+ vs. Control.||0.15|-0.02|0.53
72396484|NCT00333866|144299032|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.92|||<|0.0001|TWO_SIDED|95.0|-1.3|-0.5|||Mixed Model Repeated Measures ANCOVA|||Week 7: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.||-0.5|-1.3|<.0001
72506001|NCT03320512|144543608|SUPERIORITY||Average Treatment Effect|0.0||||0.96|TWO_SIDED|95.0|-0.12|0.12||P-values adjusted using the Benjamini Hochberg procedure.|TMLE estimation of ATE and Wald test|||Month 6 The analysis includes the intent-to-treat population and compares P3 and P3+ vs. Control.||0.12|-0.12|0.96
72622923|NCT05430919|144775948|SUPERIORITY||Least Squares (LS) Mean Difference|-2.31|||<|0.0001|TWO_SIDED|95.0|-3.229|-1.385|||ANCOVA||REGN5713-5714-5715 900 mg vs. Placebo, Day 29|||-1.385|-3.229|<0.0001
72396485|NCT00333866|144299032|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.59||||0.0037|TWO_SIDED|95.0|-1.0|-0.2|||Mixed Model Repeated Measures ANCOVA|||Week 7: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.||-0.2|-1.0|0.0037
72396486|NCT00333866|144299032|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.27|||<|0.0001|TWO_SIDED|95.0|-1.7|-0.9|||Mixed Model Repeated Measures ANCOVA|||Week 8: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.||-0.9|-1.7|<.0001
72396487|NCT00333866|144299032|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.97|||<|0.0001|TWO_SIDED|95.0|-1.4|-0.6|||Mixed Model Repeated Measures ANCOVA|||Week 8: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.||-0.6|-1.4|<.0001
72396488|NCT00333866|144299032|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.61||||0.0031|TWO_SIDED|95.0|-1.0|-0.2|||Mixed Model Repeated Measures ANCOVA|||Week 8: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.||-0.2|-1.0|0.0031
72396489|NCT00333866|144299032|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.12|||<|0.0001|TWO_SIDED|95.0|-1.5|-0.7|||Mixed Model Repeated Measures ANCOVA|||Week 9: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.||-0.7|-1.5|<.0001
72396490|NCT00333866|144299032|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.83|||<|0.0001|TWO_SIDED|95.0|-1.2|-0.4|||Mixed Model Repeated Measures ANCOVA|||Week 9: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.||-0.4|-1.2|<.0001
72396491|NCT00333866|144299032|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.53||||0.0117|TWO_SIDED|95.0|-0.9|-0.1|||Mixed Model Repeated Measures ANCOVA|||Week 9: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.||-0.1|-0.9|0.0117
72396492|NCT00333866|144299032|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.2|||<|0.0001|TWO_SIDED|95.0|-1.6|-0.8|||Mixed Model Repeated Measures ANCOVA|||Week 10: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.||-0.8|-1.6|<.0001
72396493|NCT00333866|144299032|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.9|||<|0.0001|TWO_SIDED|95.0|-1.3|-0.5|||Mixed Model Repeated Measures ANCOVA|||Week 10: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.||-0.5|-1.3|<.0001
72396494|NCT00333866|144299032|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.61||||0.004|TWO_SIDED|95.0|-1.0|-0.2|||Mixed Model Repeated Measures ANCOVA|||Week 10: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.||-0.2|-1.0|0.0040
72396495|NCT00333866|144299032|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.15|||<|0.0001|TWO_SIDED|95.0|-1.6|-0.7|||Mixed Model Repeated Measures ANCOVA|||Week 11: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.||-0.7|-1.6|<.0001
72396496|NCT00333866|144299032|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.83|||<|0.0001|TWO_SIDED|95.0|-1.2|-0.4|||Mixed Model Repeated Measures ANCOVA|||Week 11: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.||-0.4|-1.2|<.0001
72396497|NCT00333866|144299032|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.56||||0.01|TWO_SIDED|95.0|-1.0|-0.1|||Mixed Model Repeated Measures ANCOVA|||Week 11: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.||-0.1|-1.0|0.0100
72396498|NCT00333866|144299032|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.07|||<|0.0001|TWO_SIDED|95.0|-1.5|-0.6|||Mixed Model Repeated Measures ANCOVA|||Week 12: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.||-0.6|-1.5|<.0001
72396499|NCT00333866|144299032|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.73||||0.0006|TWO_SIDED|95.0|-1.2|-0.3|||Mixed Model Repeated Measures ANCOVA|||Week 12: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.||-0.3|-1.2|0.0006
72506002|NCT03320512|144543609|SUPERIORITY||Average Treatment Effect|0.08||||0.93|TWO_SIDED|95.0|-0.84|1.0||P-values adjusted using the Benjamini Hochberg procedure.|TMLE estimation of ATE and Wald test|||Month 3 The analysis includes the intent-to-treat population and compares P3 and P3+ vs. Control.||1.00|-0.84|0.93
72396500|NCT00333866|144299032|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.4||||0.069|TWO_SIDED|95.0|-0.8|0.0|||Mixed Model Repeated Measures ANCOVA|||Week 12: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.||0.0|-0.8|0.0690
72506003|NCT03320512|144543609|SUPERIORITY||Average Treatment Effect|-1.12||||0.6|TWO_SIDED|95.0|-4.16|1.91||P-values adjusted using the Benjamini Hochberg procedure.|TMLE estimation of ATE and Wald test|||Month 6 The analysis includes the intent-to-treat population and compares P3 and P3+ vs. Control.||1.91|-4.16|0.60
72396501|NCT00333866|144299032|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.21|||<|0.0001|TWO_SIDED|95.0|-1.6|-0.8|||Mixed Model Repeated Measures ANCOVA|||Week 13: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.||-0.8|-1.6|<.0001
72396502|NCT00333866|144299032|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.88|||<|0.0001|TWO_SIDED|95.0|-1.3|-0.5|||Mixed Model Repeated Measures ANCOVA|||Week 13: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.||-0.5|-1.3|<.0001
72396503|NCT00333866|144299032|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.61||||0.0054|TWO_SIDED|95.0|-1.0|-0.2|||Mixed Model Repeated Measures ANCOVA|||Week 13: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.||-0.2|-1.0|0.0054
72396504|NCT00333866|144299032|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.21|||<|0.0001|TWO_SIDED|95.0|-1.6|-0.8|||Mixed Model Repeated Measures ANCOVA|||Week 14: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.||-0.8|-1.6|<.0001
72396505|NCT00333866|144299032|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.87|||<|0.0001|TWO_SIDED|95.0|-1.3|-0.4|||Mixed Model Repeated Measures ANCOVA|||Week 14: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.||-0.4|-1.3|<.0001
72396506|NCT00333866|144299032|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.65||||0.0036|TWO_SIDED|95.0|-1.1|-0.2|||Mixed Model Repeated Measures ANCOVA|||Week 14: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.||-0.2|-1.1|0.0036
72396507|NCT00333866|144299032|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.16|||<|0.0001|TWO_SIDED|95.0|-1.5|-0.9|||Mixed Model Repeated Measures ANCOVA|||Overall: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.||-0.9|-1.5|<.0001
72396508|NCT00333866|144299032|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.86|||<|0.0001|TWO_SIDED|95.0|-1.1|-0.6|||Mixed Model Repeated Measures ANCOVA|||Overall: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.||-0.6|-1.1|<.0001
72396509|NCT00333866|144299032|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.66|||<|0.0001|TWO_SIDED|95.0|-1.0|-0.4|||Mixed Model Repeated Measures ANCOVA|||Overall: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.||-0.4|-1.0|<.0001
72471633|NCT00474526|144466761|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA3 over LA4, the lower limit of two-sided 95% CI for the ratio of pertussis GMCs (GMCLA3 / GMCLA4) must be greater than 0.67; the lower limit of the two-sided 95% CI for the ratio of GMCs (GMCLA3 / GMCLA4) or GMTs (poliovirus antigens) for the other antigens must be greater than 0.50.|Ratio of GMCs|0.88|||||TWO_SIDED|95.0|0.69|1.12|||ANOVA|||PnC 23F (Post-vaccination GMC; group ratio LA3:LA4)||1.12|0.69|
72471634|NCT00474526|144466762|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the difference in seroresponse rates (PLA1 - PLA2) must be greater than -5% for poliovirus and greater than -10% for all other antigens.|Seroconversion Percentage difference|0.0|||||TWO_SIDED|95.0|-2.2|4.4|||ANOVA|||Diphtheria (Seroconversion percentage difference (PLA1 - PLA2))||4.4|-2.2|
72506004|NCT03320512|144543610|SUPERIORITY||Average Treatment Effect|0.73||||0.6|TWO_SIDED|95.0|-1.03|2.48||P-values adjusted using the Benjamini Hochberg procedure.|TMLE estimation of ATE and Wald test|||Month 3 The analysis includes the intent-to-treat population and compares P3 and P3+ vs. Control.||2.48|-1.03|0.60
72506005|NCT03320512|144543610|SUPERIORITY||Average Treatment Effect|-0.91||||0.6|TWO_SIDED|95.0|-2.86|1.04||P-values adjusted using the Benjamini Hochberg procedure.|TMLE estimation of ATE and Wald test|||Month 6 The analysis includes the intent-to-treat population and compares P3 and P3+ vs. Control.||1.04|-2.86|0.60
72506006|NCT03320512|144543611|SUPERIORITY||Average Treatment Effect|-0.06||||0.6|TWO_SIDED|95.0|-0.2|0.08||P-values adjusted using the Benjamini Hochberg procedure.|TMLE estimation of ATE and Wald test|||Month 3 Gonorrhea The analysis includes the intent-to-treat population and compares P3 and P3+ vs. Control.||0.08|-0.20|0.60
72396510|NCT00333866|144299033|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.17||||0.537|TWO_SIDED|95.0|0.71|1.95|||Regression, Logistic|||P-values less than 0.05 (2-sided) considered statistically significant. Logistic regression method was used with treatment and center in the model, and the baseline score as covariate.||1.95|0.71|0.5370
72396511|NCT00333866|144299033|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.92||||0.0109|TWO_SIDED|95.0|1.16|3.18|||Regression, Logistic|||P-values less than 0.05 (2-sided) considered statistically significant. Logistic regression method was used with treatment and center in the model, and the baseline score as covariate.||3.18|1.16|0.0109
72396512|NCT00333866|144299033|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.01||||0.9613|TWO_SIDED|95.0|0.61|1.68|||Regression, Logistic|||P-values less than 0.05 (2-sided) considered statistically significant. Logistic regression method was used with treatment and center in the model, and the baseline score as covariate.||1.68|0.61|0.9613
72471635|NCT00474526|144466762|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the difference in seroresponse rates (PLA1 - PLA2) must be greater than -5% for poliovirus and greater than -10% for all other antigens.|Seroconversion Percentage difference|0.0|||||TWO_SIDED|95.0|-1.9|2.6|||ANOVA|||Tetanus (Seroconversion percentage difference (PLA1 - PLA2))||2.6|-1.9|
72506007|NCT03320512|144543611|SUPERIORITY||Average Treatment Effect|-0.06||||0.6|TWO_SIDED|95.0|-0.21|0.09||P-values adjusted using the Benjamini Hochberg procedure.|TMLE estimation of ATE and Wald test|||Month 6 Gonorrhea The analysis includes the intent-to-treat population and compares P3 and P3+ vs. Control.||0.09|-0.21|0.60
72396513|NCT00333866|144299034|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-12.71|||<|0.0001|TWO_SIDED|95.0|-17.56|-7.86|||ANCOVA|||Sleep Disturbance: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||-7.86|-17.56|<.0001
72396514|NCT00333866|144299034|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-13.28|||<|0.0001|TWO_SIDED|95.0|-18.18|-8.38|||ANCOVA|||Sleep Disturbance: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||-8.38|-18.18|<.0001
72396515|NCT00333866|144299034|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-7.2||||0.0038|TWO_SIDED|95.0|-12.06|-2.33|||ANCOVA|||Sleep Disturbance: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||-2.33|-12.06|0.0038
72396516|NCT00333866|144299034|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|5.9||||0.0142|TWO_SIDED|95.0|1.19|10.61|||ANCOVA|||Snoring: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||10.61|1.19|0.0142
72396517|NCT00333866|144299034|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|4.92||||0.0414|TWO_SIDED|95.0|0.19|9.66|||ANCOVA|||Snoring: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||9.66|0.19|0.0414
72396518|NCT00333866|144299034|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.21||||0.6165|TWO_SIDED|95.0|-3.53|5.95|||ANCOVA|||Snoring: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||5.95|-3.53|0.6165
72471636|NCT00474526|144466762|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the difference in seroresponse rates (PLA1 - PLA2) must be greater than -5% for poliovirus and greater than -10% for all other antigens.|Seroconversion Percentage difference|-1.0|||||TWO_SIDED|95.0|-7.7|7.1|||ANOVA|||PT (Seroconversion percentage difference (PLA1 - PLA2))||7.1|-7.7|
72396519|NCT00333866|144299034|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-9.24||||0.0005|TWO_SIDED|95.0|-14.44|-4.05|||ANCOVA|||Shortness of Breath, Headache: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||-4.05|-14.44|0.0005
72396520|NCT00333866|144299034|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-11.92|||<|0.0001||95.0|-17.17|-6.68|||ANCOVA|||Shortness of Breath, Headache: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||-6.68|-17.17|<.0001
72506008|NCT03320512|144543611|SUPERIORITY||Average Treatment Effect|-0.13||||0.53|TWO_SIDED|95.0|-0.3|0.03||P-values adjusted using the Benjamini Hochberg procedure.|TMLE estimation of ATE and Wald test|||Month 3 Chlamydia The analysis includes the intent-to-treat population and compares P3 and P3+ vs. Control.||0.03|-0.30|0.53
72506009|NCT03320512|144543611|SUPERIORITY||Average Treatment Effect|-0.08||||0.6|TWO_SIDED|95.0|-0.24|0.08||P-values adjusted using the Benjamini Hochberg procedure.|TMLE estimation of ATE and Wald test|||Month 6 Chlamydia The analysis includes the intent-to-treat population and compares P3 and P3+ vs. Control.||0.08|-0.24|0.60
72396521|NCT00333866|144299034|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-8.95||||0.0008|TWO_SIDED|95.0|-14.16|-3.74|||ANCOVA|||Shortness of Breath, Headache: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||-3.74|-14.16|0.0008
72396522|NCT00333866|144299034|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.36||||0.0127|TWO_SIDED|95.0|0.08|0.64|||ANCOVA|||Quantity of Sleep: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||0.64|0.08|0.0127
72396523|NCT00333866|144299034|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.5||||0.0005|TWO_SIDED|95.0|0.22|0.79|||ANCOVA|||Quantity of Sleep: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||0.79|0.22|0.0005
72396524|NCT00333866|144299034|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.21||||0.1453|TWO_SIDED|95.0|-0.07|0.49|||ANCOVA|||Quality of Sleep: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||0.49|-0.07|0.1453
72396525|NCT00333866|144299034|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|4.34||||0.1033|TWO_SIDED|95.0|-0.88|9.57|||ANCOVA|||Sleep Adequacy: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||9.57|-0.88|0.1033
72396526|NCT00333866|144299034|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|9.14||||0.0007|TWO_SIDED|95.0|3.88|14.41|||ANCOVA|||Sleep Adequacy: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||14.41|3.88|0.0007
72396527|NCT00333866|144299034|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|2.56||||0.337|TWO_SIDED|95.0|-2.68|7.81|||ANCOVA|||Sleep Adequacy: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||7.81|-2.68|0.3370
72396528|NCT00333866|144299034|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|2.01||||0.3308|TWO_SIDED|95.0|-2.05|6.07|||ANCOVA|||Somnolence: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||6.07|-2.05|0.3308
72396529|NCT00333866|144299034|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.7||||0.7364|TWO_SIDED|95.0|-3.39|4.8|||ANCOVA|||Somnolence: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||4.80|-3.39|0.7364
72506010|NCT03320512|144543611|SUPERIORITY||Average Treatment Effect|-0.11||||0.53|TWO_SIDED|95.0|-0.25|0.04||P-values adjusted using the Benjamini Hochberg procedure.|TMLE estimation of ATE and Wald test|||Month 3 Syphillis The analysis includes the intent-to-treat population and compares P3 and P3+ vs. Control.||0.04|-0.25|0.53
72622924|NCT05430919|144775949|SUPERIORITY||LS Mean Difference|-2.65|||<|0.0001|TWO_SIDED|95.0|-3.634|-1.658|||ANCOVA||REGN5713-5715 600 mg vs. Placebo, Day 29|||-1.658|-3.634|<0.0001
72396530|NCT00333866|144299034|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.76||||0.7132|TWO_SIDED|95.0|-3.31|4.84|||ANCOVA|||Somnolence: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||4.84|-3.31|0.7132
72396531|NCT00333866|144299034|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-6.9||||0.0002|TWO_SIDED|95.0|-10.54|-3.25|||ANCOVA|||Overall sleep Problem Index: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||-3.25|-10.54|0.0002
72396532|NCT00333866|144299034|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-8.25|||<|0.0001|TWO_SIDED|95.0|-11.94|-4.55|||ANCOVA|||Overall Sleep Problem Index: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||-4.55|-11.94|<.0001
72396533|NCT00333866|144299034|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-4.36||||0.0197|TWO_SIDED|95.0|-8.02|-0.7|||ANCOVA|||Overall Sleep Problem Index: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||-0.70|-8.02|0.0197
72396534|NCT00333866|144299035|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.17||||0.3627|TWO_SIDED|95.0|-0.54|0.2|||ANCOVA|||FIQ Physical Impairment: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||0.20|-0.54|0.3627
72471637|NCT00474526|144466762|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the difference in seroresponse rates (PLA1 - PLA2) must be greater than -5% for poliovirus and greater than -10% for all other antigens.|Seroconversion Percentage difference|-2.0|||||TWO_SIDED|95.0|-9.2|5.8|||ANOVA|||FHA(Seroconversion percentage difference (PLA1 - PLA2))||5.8|-9.2|
72471638|NCT00474526|144466762|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the difference in seroresponse rates (PLA1 - PLA2) must be greater than -5% for poliovirus and greater than -10% for all other antigens.|Seroconversion Percentage difference|-6.0||||||95.0|-12.9|2.2|||ANOVA|||Pertactin (Seroconversion percentage difference (PLA1 - PLA2))||2.2|-12.9|
72396535|NCT00333866|144299035|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.26||||0.1686|TWO_SIDED|95.0|-0.63|0.11|||ANCOVA|||FIQ Physical Impairment: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||0.11|-0.63|0.1686
72396536|NCT00333866|144299035|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.18||||0.3468|TWO_SIDED|95.0|-0.55|0.19|||ANCOVA|||FIQ Physical Impairment: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||0.19|-0.55|0.3468
72396537|NCT00333866|144299035|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.11||||0.7147|TWO_SIDED|95.0|-0.71|0.49|||ANCOVA|||FIQ Feel Good: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||0.49|-0.71|0.7147
72396538|NCT00333866|144299035|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.63||||0.0409|TWO_SIDED|95.0|-1.23|-0.03|||ANCOVA|||FIQ Feel Good: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||-0.03|-1.23|0.0409
72396539|NCT00333866|144299035|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.04||||0.9077|TWO_SIDED|95.0|-0.56|0.63|||ANCOVA|||FIQ Feel Good: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||0.63|-0.56|0.9077
72396540|NCT00333866|144299035|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.14||||0.5923|TWO_SIDED|95.0|-0.64|0.37|||ANCOVA|||FIQ Work Missed: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||0.37|-0.64|0.5923
72396541|NCT00333866|144299035|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.61||||0.0174|TWO_SIDED|95.0|-1.12|-0.11|||ANCOVA|||FIQ Work Missed: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||-0.11|-1.12|0.0174
72396542|NCT00333866|144299035|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.16||||0.5408|TWO_SIDED|95.0|-0.66|0.35|||ANCOVA|||FIQ Work Missed: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||0.35|-0.66|0.5408
72396543|NCT00333866|144299035|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.09||||0.7236|TWO_SIDED|95.0|-0.57|0.4|||ANCOVA|||FIQ Do Work: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||0.40|-0.57|0.7236
72471639|NCT00474526|144466762|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the difference in seroresponse rates (PLA1 - PLA2) must be greater than -5% for poliovirus and greater than -10% for all other antigens.|Seroconversion Percentage difference|-2.0|||||TWO_SIDED|95.0|-4.8|1.0|||ANOVA|||Polio Type 1 (Seroconversion percentage difference (PLA1 - PLA2))||1.0|-4.8|
72506011|NCT03320512|144543611|SUPERIORITY||Average Treatment Effect|-0.07||||0.6|TWO_SIDED|95.0|-0.2|0.07||P-values adjusted using the Benjamini Hochberg procedure.|TMLE estimation of ATE and Wald test|||Month 6 Syphillis The analysis includes the intent-to-treat population and compares P3 and P3+ vs. Control.||0.07|-0.20|0.60
72396544|NCT00333866|144299035|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.71||||0.0045|TWO_SIDED|95.0|-1.19|-0.22|||ANCOVA|||FIQ Do Work: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||-0.22|-1.19|0.0045
72396545|NCT00333866|144299035|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.14||||0.5613||95.0|-0.63|0.34|||ANCOVA|||FIQ Do Work: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||0.34|-0.63|0.5613
72471640|NCT00474526|144466762|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the difference in seroresponse rates (PLA1 - PLA2) must be greater than -5% for poliovirus and greater than -10% for all other antigens.|Seroconversion Percentage difference|-2.0|||||TWO_SIDED|95.0|-4.6|2.3|||ANOVA|||Polio Type 2 (Seroconversion percentage difference (PLA1 - PLA2))||2.3|-4.6|
72396546|NCT00333866|144299035|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.14||||0.5609|TWO_SIDED|95.0|-0.6|0.33|||ANCOVA|||FIQ Pain: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||0.33|-0.60|0.5609
72396547|NCT00333866|144299035|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.75||||0.0016|TWO_SIDED|95.0|-1.22|-0.28|||ANCOVA|||FIQ Pain: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||-0.28|-1.22|0.0016
72396548|NCT00333866|144299035|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.21||||0.3692|TWO_SIDED|95.0|-0.68|0.25|||ANCOVA|||FIQ Pain: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||0.25|-0.68|0.3692
72396549|NCT00333866|144299035|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.24||||0.3294|TWO_SIDED|95.0|-0.73|0.25|||ANCOVA|||FIQ Fatigue: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||0.25|-0.73|0.3294
72396550|NCT00333866|144299035|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.56||||0.027|TWO_SIDED|95.0|-1.05|-0.06|||ANCOVA|||FIQ Fatigue: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||-0.06|-1.05|0.0270
72396551|NCT00333866|144299035|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.05||||0.8432|TWO_SIDED|95.0|-0.54|0.44|||ANCOVA|||FIQ Fatigue: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||0.44|-0.54|0.8432
72396552|NCT00333866|144299035|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.46||||0.0806|TWO_SIDED|95.0|-0.98|0.06|||ANCOVA|||FIQ Rested: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||0.06|-0.98|0.0806
72396553|NCT00333866|144299035|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.53||||0.047|TWO_SIDED|95.0|-1.06|-0.01|||ANCOVA|||FIQ Rested: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||-0.01|-1.06|0.0470
72396554|NCT00333866|144299035|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.23||||0.3845|TWO_SIDED|95.0|-0.75|0.29|||ANCOVA|||FIQ Rested: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||0.29|-0.75|0.3845
72396555|NCT00333866|144299035|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.12||||0.6326|TWO_SIDED|95.0|-0.37|0.6|||ANCOVA|||FIQ Stiffness: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||0.60|-0.37|0.6326
72396556|NCT00333866|144299035|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.22||||0.374|TWO_SIDED|95.0|-0.71|0.27|||ANCOVA|||FIQ Stiffness: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||0.27|-0.71|0.3740
72396557|NCT00333866|144299035|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.03||||0.8936|TWO_SIDED|95.0|-0.45|0.52|||ANCOVA|||FIQ Stiffness: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||0.52|-0.45|0.8936
72396558|NCT00333866|144299035|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.19||||0.4743|TWO_SIDED|95.0|-0.73|0.34|||ANCOVA|||FIQ Anxiety: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||0.34|-0.73|0.4743
72506012|NCT03320512|144543612|SUPERIORITY||Average Treatment Effect|0.11|||||TWO_SIDED|95.0|-0.07|0.29|||||TMLE estimation of ATE and Wald Confidence Interval|Month 3 The analysis includes the intent-to-treat population and compares P3 vs. Control.||0.29|-0.07|
72396559|NCT00333866|144299035|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.64||||0.0192|TWO_SIDED|95.0|-1.18|-0.1|||ANCOVA|||FIQ Anxiety: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||-0.10|-1.18|0.0192
72396560|NCT00333866|144299035|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.18||||0.5101|TWO_SIDED|95.0|-0.71|0.35|||ANCOVA|||FIQ anxiety: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||0.35|-0.71|0.5101
72506013|NCT03320512|144543612|SUPERIORITY||Average Treatment Effect|0.19|||||TWO_SIDED|95.0|0.03|0.34|||||TMLE estimation of ATE and Wald Confidence Interval|Month 3 The analysis includes the intent-to-treat population and compares P3+ vs. Control.||0.34|0.03|
72396561|NCT00333866|144299035|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.2||||0.4617|TWO_SIDED|95.0|-0.75|0.34|||ANCOVA|||FIQ Depression: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||0.34|-0.75|0.4617
72396562|NCT00333866|144299035|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.97||||0.0006|TWO_SIDED|95.0|-1.51|-0.42|||ANCOVA|||FIQ Depression: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||-0.42|-1.51|0.0006
72396563|NCT00333866|144299035|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.33||||0.229|TWO_SIDED|95.0|-0.88|0.21|||ANCOVA|||FIQ Depression: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||0.21|-0.88|0.2290
72506014|NCT03320512|144543612|SUPERIORITY||Average Treatment Effect|-0.06|||||TWO_SIDED|95.0|-0.27|0.15|||||TMLE estimation of ATE and Wald Confidence Interval|Month 6 The analysis includes the intent-to-treat population and compares P3 vs. Control.||0.15|-0.27|
72506015|NCT03320512|144543612|SUPERIORITY||Average Treatment Effect|-0.02|||||TWO_SIDED|95.0|-0.21|0.16|||||TMLE estimation of ATE and Wald Confidence Interval|Month 6 The analysis includes the intent-to-treat population and compares P3+ vs. Control.||0.16|-0.21|
72396564|NCT00333866|144299036|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.44||||0.42|TWO_SIDED|95.0|-4.95|2.06|||ANCOVA|||P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||2.06|-4.95|0.4200
72396565|NCT00333866|144299036|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-5.85||||0.0012|TWO_SIDED|95.0|-9.38|-2.31|||ANCOVA|||P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||-2.31|-9.38|0.0012
72396566|NCT00333866|144299036|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.17||||0.5126|TWO_SIDED|95.0|-4.68|2.34|||ANCOVA|||P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||2.34|-4.68|0.5126
72471641|NCT00474526|144466762|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the difference in seroresponse rates (PLA1 - PLA2) must be greater than -5% for poliovirus and greater than -10% for all other antigens.|Seroconversion Percentage difference|0.0|||||TWO_SIDED|95.0|-3.2|5.1|||ANOVA|||Polio Type 3 (Seroconversion percentage difference (PLA1 - PLA2))||5.1|-3.2|
72471642|NCT00474526|144466762|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the difference in seroresponse rates (PLA1 - PLA2) must be greater than -5% for poliovirus and greater than -10% for all other antigens.|Seroconversion Percentage difference|0.0|||||TWO_SIDED|95.0|-1.5|3.5|||ANOVA|||Hepatitis B (Seroconversion percentage difference (PLA1 - PLA2))||3.5|-1.5|
72471643|NCT00474526|144466762|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the difference in seroresponse rates (PLA1 - PLA2) must be greater than -5% for poliovirus and greater than -10% for all other antigens.|Seroconversion Percentage difference|1.0|||||TWO_SIDED|95.0|-1.1|5.0|||ANOVA|||Hib (≥ 0.15 μg/mL)(Seroconversion percentage difference (PLA1 - PLA2))||5|-1.1|
72471644|NCT00474526|144466762|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the difference in seroresponse rates (PLA1 - PLA2) must be greater than -5% for poliovirus and greater than -10% for all other antigens.|Seroconversion Percentage difference|2.0||||||95.0|-2.8|7.7|||ANOVA|||Hib (≥1.0 μg/mL)(Seroconversion percentage difference (PLA1 - PLA2))||7.7|-2.8|
72471645|NCT00474526|144466762|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the difference in seroresponse rates (PLA1 - PLA2) must be greater than -5% for poliovirus and greater than -10% for all other antigens.|Seroconversion Percentage difference|-1.0|||||TWO_SIDED|95.0|-3.0|3.3|||ANOVA|||PnC 4(Seroconversion percentage difference (PLA1 - PLA2))||3.3|-3|
72471646|NCT00474526|144466762|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the difference in seroresponse rates (PLA1 - PLA2) must be greater than -5% for poliovirus and greater than -10% for all other antigens.|Seroconversion Percentage difference|4.0|||||TWO_SIDED|95.0|-2.2|12.3|||ANOVA|||PnC 6B(Seroconversion percentage difference (PLA1 - PLA2))||12.3|-2.2|
72471647|NCT00474526|144466762|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the difference in seroresponse rates (PLA1 - PLA2) must be greater than -5% for poliovirus and greater than -10% for all other antigens.|Seroconversion Percentage difference|-1.0|||||TWO_SIDED|95.0|-3.9|3.6|||ANOVA|||PnC 9V (Seroconversion percentage difference (PLA1 - PLA2))||3.6|-3.9|
72471648|NCT00474526|144466762|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the difference in seroresponse rates (PLA1 - PLA2) must be greater than -5% for poliovirus and greater than -10% for all other antigens.|Seroconversion Percentage difference|1.0|||||TWO_SIDED|95.0|-1.1|6.2|||ANOVA|||PnC 14 (Seroconversion percentage difference (PLA1 - PLA2))||6.2|-1.1|
72471649|NCT00474526|144466762|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the difference in seroresponse rates (PLA1 - PLA2) must be greater than -5% for poliovirus and greater than -10% for all other antigens.|Seroconversion Percentage difference|-2.0|||||TWO_SIDED|95.0|-4.8|2.9|||ANOVA|||PnC 18C (Seroconversion percentage difference (PLA1 - PLA2))||2.9|-4.8|
72396567|NCT00333866|144299037|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.51||||0.7781|TWO_SIDED|95.0|-4.07|3.05|||ANCOVA|||Physical functioning: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||3.05|-4.07|0.7781
72396568|NCT00333866|144299037|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.99||||0.2792|TWO_SIDED|95.0|-1.62|5.59|||ANCOVA|||Physical Functioning: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||5.59|-1.62|0.2792
72396569|NCT00333866|144299037|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.58||||0.7512|TWO_SIDED|95.0|-3.0|4.15|||ANCOVA|||Physical Functioning: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||4.15|-3.00|0.7512
72471650|NCT00474526|144466762|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the difference in seroresponse rates (PLA1 - PLA2) must be greater than -5% for poliovirus and greater than -10% for all other antigens.|Seroconversion Percentage difference|-2.0|||||TWO_SIDED|95.0|-4.8|2.9|||ANOVA|||PnC 19F (Seroconversion percentage difference (PLA1 - PLA2))||2.9|-4.8|
72471651|NCT00474526|144466762|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the difference in seroresponse rates (PLA1 - PLA2) must be greater than -5% for poliovirus and greater than -10% for all other antigens.|Seroconversion Percentage difference|-4.0|||||TWO_SIDED|95.0|-8.0|1.9|||ANOVA|||PnC 23F (Seroconversion percentage difference (PLA1 - PLA2))||1.9|-8|
72471652|NCT00474526|144466762|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA3 over LA4, the lower limit of the two-sided 95% CI for the difference in seroresponse rates (PLA3 - PLA4) must be greater than 5% for poliovirus and greater than -10% for all other antigens.|Seroconversion Percentage difference|0.0|||||TWO_SIDED|95.0|-2.3|3.8|||ANOVA|||Diphtheria (Seroconversion percentage difference (PLA3 - PLA4))||3.8|-2.3|
72506016|NCT03320512|144543613|SUPERIORITY||Average Treatment Effect|0.11|||||TWO_SIDED|95.0|-0.05|0.26|||||TMLE estimation of ATE and Wald Confidence Interval|Month 3 The analysis includes the intent-to-treat population and compares P3 vs. Control.||0.26|-0.05|
72506017|NCT03320512|144543613|SUPERIORITY||Average Treatment Effect|0.13|||||TWO_SIDED|95.0|-0.04|0.29|||||TMLE estimation of ATE and Wald Confidence Interval|Month 3 The analysis includes the intent-to-treat population and compares P3+ vs. Control.||0.29|-0.04|
72506018|NCT03320512|144543613|SUPERIORITY||Average Treatment Effect|0.09|||||TWO_SIDED|95.0|-0.08|0.26|||||TMLE estimation of ATE and Wald Confidence Interval|Month 6 The analysis includes the intent-to-treat population and compares P3 vs. Control.||0.26|-0.08|
72396570|NCT00333866|144299037|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.02||||0.649|TWO_SIDED|95.0|-3.39|5.43|||ANCOVA|||Physical role Limitations: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||5.43|-3.39|0.6490
72396571|NCT00333866|144299037|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.5||||0.5105|TWO_SIDED|95.0|-2.96|5.96|||ANCOVA|||Physical Role Limitations: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||5.96|-2.96|0.5105
72396572|NCT00333866|144299037|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.39||||0.8625|TWO_SIDED|95.0|-4.04|4.82|||ANCOVA|||Physical Role Limitations: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||4.82|-4.04|0.8625
72396573|NCT00333866|144299037|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|3.87||||0.1489|TWO_SIDED|95.0|-1.39|9.12|||ANCOVA|||Emotional Role Limitations: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||9.12|-1.39|0.1489
72396574|NCT00333866|144299037|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|6.24||||0.0213|TWO_SIDED|95.0|0.93|11.54|||ANCOVA|||Emotional Role Limitations: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||11.54|0.93|0.0213
72396575|NCT00333866|144299037|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|3.75||||0.162|TWO_SIDED|95.0|-1.51|9.02|||ANCOVA|||Emotional Role Limitations: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||9.02|-1.51|0.1620
72396576|NCT00333866|144299037|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|2.85||||0.2446|TWO_SIDED|95.0|-1.95|7.65|||ANCOVA|||Social Functioning: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||7.65|-1.95|0.2446
72396577|NCT00333866|144299037|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|5.01||||0.0429|TWO_SIDED|95.0|0.16|9.85|||ANCOVA|||Social Functioning: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||9.85|0.16|0.0429
72396578|NCT00333866|144299037|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|3.35||||0.1721|TWO_SIDED|95.0|-1.46|8.16|||ANCOVA|||Social Functioning: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||8.16|-1.46|0.1721
72396579|NCT00333866|144299037|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|4.08||||0.0291|TWO_SIDED|95.0|0.42|7.74|||ANCOVA|||Mental Health: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||7.74|0.42|0.0291
72396580|NCT00333866|144299037|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|5.93||||0.0017|TWO_SIDED|95.0|2.23|9.62|||ANCOVA|||Mental Health: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||9.62|2.23|0.0017
72396581|NCT00333866|144299037|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|3.32||||0.0763|TWO_SIDED|95.0|-0.35|6.99|||ANCOVA|||Mental Health: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||6.99|-0.35|0.0763
72396582|NCT00333866|144299037|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|2.58||||0.1524|TWO_SIDED|95.0|-0.95|6.11|||ANCOVA|||Bodily Pain: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||6.11|-0.95|0.1524
72396583|NCT00333866|144299037|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|5.36||||0.0032|TWO_SIDED|95.0|1.8|8.93|||ANCOVA|||Bodily Pain: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||8.93|1.80|0.0032
72396584|NCT00333866|144299037|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|2.82||||0.118|TWO_SIDED|95.0|-0.72|6.36|||ANCOVA|||Bodily Pain: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||6.36|-0.72|0.1180
72506019|NCT03320512|144543613|SUPERIORITY||Average Treatment Effect|0.03|||||TWO_SIDED|95.0|-0.13|0.19|||||TMLE estimation of ATE and Wald Confidence Interval|Month 6 The analysis includes the intent-to-treat population and compares P3+ vs. Control.||0.19|-0.13|
72396585|NCT00333866|144299037|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|3.15||||0.1081|TWO_SIDED|95.0|-0.69|6.99|||ANCOVA|||Vitality: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||6.99|-0.69|0.1081
72396586|NCT00333866|144299037|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|5.1||||0.0101|TWO_SIDED|95.0|1.22|8.99|||ANCOVA|||Vitality: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||8.99|1.22|0.0101
72396587|NCT00333866|144299037|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.75||||0.7031|TWO_SIDED|95.0|-3.1|4.6|||ANCOVA|||Vitality: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||4.60|-3.10|0.7031
72396588|NCT00333866|144299037|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.27||||0.4253|TWO_SIDED|95.0|-1.86|4.39|||ANCOVA|||General Health Perception: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||4.39|-1.86|0.4253
72396589|NCT00333866|144299037|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|2.73||||0.091|TWO_SIDED|95.0|-0.44|5.89|||ANCOVA|||General Health Perception: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||5.89|-0.44|0.0910
72506020|NCT03320512|144543614|SUPERIORITY||Average Treatment Effect|0.09||||0.11|TWO_SIDED|95.0|-0.02|0.19|||TMLE estimation of ATE and Wald test|||Month 3 The analysis includes the intent-to-treat population and compares P3 and P3+ vs. Control.||0.19|-0.02|0.11
72396590|NCT00333866|144299037|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.82||||0.2526|TWO_SIDED|95.0|-1.3|4.95|||ANCOVA|||General Health Perception: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||4.95|-1.30|0.2526
72396591|NCT00333866|144299037|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|2.62||||0.0195|TWO_SIDED|95.0|0.42|4.82|||ANCOVA|||Mental Component Score: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||4.82|0.42|0.0195
72396592|NCT00333866|144299037|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|3.66||||0.0013|TWO_SIDED|95.0|1.44|5.88|||ANCOVA|||Mental Component Score: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||5.88|1.44|0.0013
72396593|NCT00333866|144299037|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|2.14||||0.0568|TWO_SIDED|95.0|-0.06|4.34|||ANCOVA|||Mental Component Score: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||4.34|-0.06|0.0568
72396594|NCT00333866|144299037|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.13||||0.8529|TWO_SIDED|95.0|-1.54|1.27|||ANCOVA|||Physical Component Score: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||1.27|-1.54|0.8529
72396595|NCT00333866|144299037|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.54||||0.4564|TWO_SIDED|95.0|-0.88|1.96|||ANCOVA|||Physical Component Score: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||1.96|-0.88|0.4564
72396596|NCT00333866|144299037|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.13||||0.8576|TWO_SIDED|95.0|-1.28|1.54|||ANCOVA|||Physical Component Score: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||1.54|-1.28|0.8576
72396597|NCT00333866|144299038|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.29||||0.7384|TWO_SIDED|95.0|-1.98|1.4|||ANCOVA|||P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||1.40|-1.98|0.7384
72506021|NCT03320512|144543614|SUPERIORITY||Average Treatment Effect|-0.01||||0.82|TWO_SIDED|95.0|-0.14|0.11|||TMLE estimation of ATE and Wald test|||Month 6 The analysis includes the intent-to-treat population and compares P3 and P3+ vs. Control.||0.11|-0.14|0.82
72506022|NCT03320512|144543615|SUPERIORITY||Average Treatment Effect|8.95||||0.05|TWO_SIDED|95.0|0.07|17.83||The a priori threshold for statistical significance is 0.025.|TMLE estimation of ATE and Wald test|||Month 3 The analysis includes the intent-to-treat population and compares P3 and P3+ vs. Control.||17.83|0.07|0.05
72506023|NCT03320512|144543615|SUPERIORITY||Average Treatment Effect|-3.69||||0.45|TWO_SIDED|95.0|-13.33|5.95|||TMLE estimation of ATE and Wald test|||Month 6 The analysis includes the intent-to-treat population and compares P3 and P3+ vs. Control.||5.95|-13.33|0.45
72396598|NCT00333866|144299038|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.41||||0.1044|TWO_SIDED|95.0|-3.12|0.29|||ANCOVA|||P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||0.29|-3.12|0.1044
72396599|NCT00333866|144299038|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.87||||0.3137|TWO_SIDED|95.0|-2.58|0.83|||ANCOVA|||P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||0.83|-2.58|0.3137
72396600|NCT00333866|144299039|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.59||||0.09|TWO_SIDED|95.0|-1.28|0.09|||ANCOVA|||HADS-Anxiety Total: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||0.09|-1.28|0.0900
72396601|NCT00333866|144299039|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.5||||0.1564|TWO_SIDED|95.0|-1.2|0.19|||ANCOVA|||HADS-Anxiety Total: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||0.19|-1.20|0.1564
72471653|NCT00474526|144466762|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA3 over LA4, the lower limit of the two-sided 95% CI for the difference in seroresponse rates (PLA3 - PLA4) must be greater than 5% for poliovirus and greater than -10% for all other antigens.|Seroconversion Percentage difference|0.0||||||95.0|-1.3|2.7|||ANOVA|||Tetanus (Seroconversion percentage difference (PLA3 - PLA4))||2.7|-1.3|
72471654|NCT00474526|144466762|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA3 over LA4, the lower limit of the two-sided 95% CI for the difference in seroresponse rates (PLA3 - PLA4) must be greater than 5% for poliovirus and greater than -10% for all other antigens.|Seroconversion Percentage difference|2.0|||||TWO_SIDED|95.0|-4.8|10.7|||Seroconversion Percentage difference|||PT (Seroconversion percentage difference (PLA3 - PLA4))||10.7|-4.8|
72471655|NCT00474526|144466762|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA3 over LA4, the lower limit of the two-sided 95% CI for the difference in seroresponse rates (PLA3 - PLA4) must be greater than 5% for poliovirus and greater than -10% for all other antigens.|Seroconversion Percentage difference|0.0|||||TWO_SIDED|95.0|-7.1|8.8|||ANOVA|||FHA(Seroconversion percentage difference (PLA3 - PLA4))||8.8|-7.1|
72506024|NCT03320512|144543616|SUPERIORITY||Incremental cost effectiveness ratio|25.79|||||TWO_SIDED|95.0|-194.05|236.81|||||The confidence interval was created using percentile bootstrap.|Participants were included if they were at an active site with cost data and had a 3-month binary TFV measure.||236.81|-194.05|
72506025|NCT00638846|144543617|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.739|||||TWO_SIDED|97.4|1.136|1.739|||Generalized Linear Model||Odds ratio was senofilcon A toric / balafilcon A toric|Alternative hypothesis is senofilcon A toric is superior to balfilcon A toric by having less degrees of rotation||1.739|1.136|
72471656|NCT00474526|144466762|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA3 over LA4, the lower limit of the two-sided 95% CI for the difference in seroresponse rates (PLA3 - PLA4) must be greater than 5% for poliovirus and greater than -10% for all other antigens.|Seroconversion Percentage difference|-2.0|||||TWO_SIDED|95.0|-8.0|5.7|||ANOVA|||Pertactin (Seroconversion percentage difference (PLA3 - PLA4))||5.7|-8|
72396602|NCT00333866|144299039|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.11||||0.7519|TWO_SIDED|95.0|-0.8|0.58|||ANCOVA|||HADS-Anxiety Total: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||0.58|-0.80|0.7519
72396603|NCT00333866|144299039|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.15||||0.6416|TWO_SIDED|95.0|-0.5|0.8|||ANCOVA|||HADS-Depression Total: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||0.80|-0.50|0.6416
72396604|NCT00333866|144299039|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.59||||0.0778|TWO_SIDED|95.0|-1.25|0.07|||ANCOVA|||HADS-Depression Total: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||0.07|-1.25|0.0778
72396605|NCT00333866|144299039|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.21||||0.5191|TWO_SIDED|95.0|-0.87|0.44|||ANCOVA|||HADS-Depression Total: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||0.44|-0.87|0.5191
72396606|NCT00333866|144299040|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.44||||0.534|TWO_SIDED|95.0|-5.97|3.09|||ANCOVA|||P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||3.09|-5.97|0.5340
72396607|NCT00333866|144299040|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-7.44||||0.0014|TWO_SIDED|95.0|-12.0|-2.88|||ANCOVA|||P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||-2.88|-12.00|0.0014
72396608|NCT00333866|144299040|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-2.56||||0.2694|TWO_SIDED|95.0|-7.09|1.98|||ANCOVA|||P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||1.98|-7.09|0.2694
72396609|NCT00333866|144299041|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|263.77||||0.1277|TWO_SIDED|95.0|-75.78|603.33|||ANCOVA|||P-values less than 0.05 (2-sided) considered statistically significant. P value was calculated using analysis of variance (ANOVA), with treatment and center in the model.||603.33|-75.78|0.1277
72396610|NCT00333866|144299041|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|47.89||||0.7829|TWO_SIDED|95.0|-293.2|389.02|||ANCOVA|||P-values less than 0.05 (2-sided) considered statistically significant. P value was calculated using ANOVA, with treatment and center in the model.||389.02|-293.2|0.7829
72396611|NCT00333866|144299041|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-11.51||||0.9471|TWO_SIDED|95.0|-351.9|328.86|||ANCOVA|||P-values less than 0.05 (2-sided) considered statistically significant. P value was calculated using ANOVA, with treatment and center in the model.||328.86|-351.9|0.9471
72396612|NCT01454947|144299043|SUPERIORITY|||||||0.007||||||P values computed using difference between proportions (z value) with Bonferroni correction.|2 proportion Z-test|||||||0.007
72396613|NCT00456547|144299061|SUPERIORITY_OR_OTHER||||||<|0.05||95.0||||Adjusted for 12 comparisons|t-test, 2 sided|||||||<0.05
72396614|NCT00456547|144299062|SUPERIORITY_OR_OTHER||||||<|0.05||95.0||||Corrected for 12 comparisons.|t-test, 2 sided|||||||<0.05
72396615|NCT00456547|144299063|SUPERIORITY_OR_OTHER||||||<|0.05||95.0||||Corrected for 12 comparisons|t-test, 2 sided|||||||<0.05
72396616|NCT00456547|144299064|SUPERIORITY_OR_OTHER||||||<|0.05||95.0||||Corrected for 12 comparisons|Wilcoxon (Mann-Whitney)|||||||<0.05
72565695|NCT02709486|144662693|SUPERIORITY||Odds Ratio (OR)|2.1|||<|0.0001|TWO_SIDED|95.0|1.5|2.96|||Regression, Logistic|||Week 4, \>=30%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.96|1.50|<.0001
72396617|NCT00673465|144299102|SUPERIORITY_OR_OTHER||Difference in least squares mean|-4.4||||0.5269|TWO_SIDED|95.0|-18.5|9.7|||ANOVA|ANOVA model extracting the effect due to treatment, period, sequence and participant.||||9.7|-18.5|0.5269
72396618|NCT00673465|144299102|SUPERIORITY_OR_OTHER||Difference in least squares mean|-53.9|||<|0.0001|TWO_SIDED|95.0|-68.1|-39.8|||ANOVA|ANOVA model extracting the effect due to treatment, period, sequence and participant.||||-39.8|-68.1|<0.0001
72396619|NCT00673465|144299106|SUPERIORITY_OR_OTHER||Difference in least squares mean|-2.81||||0.741|TWO_SIDED|95.0|-20.1|14.5|||ANOVA|ANOVA model extracting the effect due to treatment, period, sequence and participant.||||14.5|-20.1|0.7410
72396620|NCT00673465|144299106|SUPERIORITY_OR_OTHER||Difference in least squares mean|-63.6|||<|0.0001|TWO_SIDED|95.0|-80.9|-46.2|||ANOVA|ANOVA model extracting the effect due to treatment, period, sequence and participant.||||-46.2|-80.9|<0.0001
72396621|NCT00673465|144299108|SUPERIORITY_OR_OTHER||Difference in least squares mean|-3.59||||0.3146|TWO_SIDED|95.0|-10.8|3.6|||ANOVA|ANOVA model extracting the effect due to treatment, period, sequence and participant.||||3.6|-10.8|0.3146
72396622|NCT00673465|144299108|SUPERIORITY_OR_OTHER||Difference in least squares mean|-26.6|||<|0.0001|TWO_SIDED|95.0|-33.8|-19.4|||ANOVA|ANOVA model extracting the effect due to treatment, period, sequence and participant.||||-19.4|-33.8|<0.0001
72396623|NCT00143403|144299129|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.9||||||95.0|0.67|1.2|||||HR: Irinotecan+5-FU/FA / 5-FU/FA|||1.20|0.67|
72396624|NCT00143403|144299129|SUPERIORITY_OR_OTHER|||||||0.468||95.0|||||Log Rank|||||||0.468
72396625|NCT00514540|144299131|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.005|ONE_SIDED|95.0||||"Stoppage of trial early if 1) probability of response with the frontline treatment DC in the 1st 2 courses is unacceptably low compared to a target of 30% Pr(p1\*p2 \> .30\|data) \< 0.005, or 2) risk of a SAE is unacceptably high Pr(m \> m\* \|data) \< 0.001"|Bayesian probability model|Operating Characteristics of futility monitoring rule 1 \& safety monitoring rule 2 applied simultaneously for frontline treatment DC in courses 1 \& 2.||Disease status evaluated at the end of course 1 \& the end of course 2. Primary outcomes are response, defined as the absence of disease progression, and the time to a serious adverse event (SAE), defined as grade 3 or 4 neurotoxicity or death. Bayesian probability model \& decision rules used to monitor patient outcomes.||||< 0.005
72396626|NCT02756689|144299140|SUPERIORITY|||||||0.38|||||||t-test, 2 sided|||||||0.38
72396627|NCT02756689|144299141|SUPERIORITY|||||||0.29|||||||t-test, 2 sided|||||||0.29
72622925|NCT05430919|144775949|SUPERIORITY||LS Mean Difference|-1.51||||0.0023|TWO_SIDED|95.0|-2.478|-0.539|||ANCOVA||REGN5715 300 mg vs. Placebo, Day 29|||-0.539|-2.478|0.0023
72396628|NCT02756689|144299142|SUPERIORITY||Risk Ratio (RR)|2.1||||0.09|TWO_SIDED|95.0|0.8|5.3|||Chi-squared|||||5.3|0.8|0.09
72396629|NCT02756689|144299143|SUPERIORITY|||||||0.12|||||||Chi-squared|||||||0.12
72396630|NCT02756689|144299144|SUPERIORITY||Risk Ratio (RR)|3.3||||0.06|TWO_SIDED|95.0|0.9|11.4|||Chi-squared|||||11.4|0.9|0.06
72396631|NCT02756689|144299145|SUPERIORITY||Risk Ratio (RR)|0.8||||0.74|TWO_SIDED|95.0|0.2|2.8|||Chi-squared|||||2.8|0.2|0.74
72396632|NCT02756689|144299146|SUPERIORITY|||||||1|||||||Chi-squared|||||||1
72396633|NCT02756689|144299147|SUPERIORITY|||||||0.82|||||||t-test, 2 sided|||||||0.82
72396634|NCT02756689|144299148|SUPERIORITY|||||||0.38|||||||t-test, 2 sided|||||||0.38
72396635|NCT02756689|144299149|SUPERIORITY|||||||0.42|||||||t-test, 2 sided|||||||0.42
72396636|NCT02756689|144299150|SUPERIORITY|||||||0.06|||||||t-test, 2 sided|||||||0.06
72396637|NCT02756689|144299151|SUPERIORITY||Risk Ratio (RR)|1.0|||>|0.99|TWO_SIDED|95.0|0.2|4.7|||Chi-squared|||||4.7|0.2|>0.99
72396638|NCT02756689|144299152|SUPERIORITY||Risk Ratio (RR)|0.7||||0.43|TWO_SIDED|95.0|0.3|1.7|||Chi-squared|||||1.7|0.3|0.43
72396639|NCT02756689|144299153|SUPERIORITY||Risk Ratio (RR)|0.3||||0.09|TWO_SIDED|95.0|0.1|1.3|||Chi-squared|||||1.3|0.1|0.09
72506026|NCT00638846|144543618|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.138|||||TWO_SIDED|97.4|0.624|1.138|||Generalized Linear Model||Odds ratio was senofilcon A toric/balafilcon A toric|Alternative hypothesis is that senofilcon A toric is superior to balafilcon A toric by having less degrees of instability.||1.138|0.624|
72506027|NCT00638846|144543619|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.1307|STANDARD_ERROR_OF_MEAN|0.2856|||TWO_SIDED|97.5|-1.1307|-0.568|||Mixed Models Analysis||The mean difference is calculated as senofilcon A toric minus balafilcon At toric.|Alternative hypothesis is that senofilcon A toric is superior to balafilcon A toric by having less time required to fit.||-0.5680|-1.1307|
72396640|NCT02756689|144299154|SUPERIORITY||Risk Ratio (RR)|0.7||||0.68|TWO_SIDED|95.0|0.1|3.8|||Chi-squared|||||3.8|0.1|0.68
72396641|NCT02756689|144299155|SUPERIORITY||Risk Ratio (RR)|0.8||||0.73|TWO_SIDED|95.0|0.3|2.6|||Chi-squared|||||2.6|0.3|0.73
72396642|NCT02756689|144299156|SUPERIORITY|||||||0.5|||||||Chi-squared|||||||0.5
72396643|NCT02756689|144299157|SUPERIORITY||Risk Ratio (RR)|1.0|||>|0.99|TWO_SIDED|95.0|0.1|15.4|||Chi-squared|||||15.4|0.1|>0.99
72396644|NCT02756689|144299158|SUPERIORITY||||||>|0.99|||||||Chi-squared|||||||>0.99
72396645|NCT02756689|144299159|SUPERIORITY|||||||0.5|||||||Chi-squared|||||||0.5
72396646|NCT02756689|144299160|SUPERIORITY||Risk Ratio (RR)|0.3||||0.37|TWO_SIDED|95.0|0.03|2.3|||Chi-squared|||||2.3|0.03|0.37
72396647|NCT02756689|144299161|SUPERIORITY||||||>|0.99|||||||Chi-squared|||||||>0.99
72396648|NCT02756689|144299162|SUPERIORITY||Risk Ratio (RR)|0.5||||0.62|TWO_SIDED|95.0|0.05|5.3|||Chi-squared|||||5.3|0.05|0.62
72396649|NCT02756689|144299163|SUPERIORITY||Risk Ratio (RR)|1.0|||>|0.99|TWO_SIDED|95.0|0.3|3.2|||Chi-squared|||||3.2|0.3|>0.99
72396650|NCT02756689|144299164|SUPERIORITY|||||||0.234|||||||Wilcoxon (Mann-Whitney)|||||||0.234
72396651|NCT02756689|144299165|SUPERIORITY|||||||0.68|||||||Wilcoxon (Mann-Whitney)|||||||0.68
72396652|NCT02756689|144299166|SUPERIORITY|||||||0.77|||||||Wilcoxon (Mann-Whitney)|||||||0.77
72396653|NCT02756689|144299167|SUPERIORITY|||||||0.5|||||||Wilcoxon (Mann-Whitney)|||||||0.5
72396654|NCT02756689|144299168|SUPERIORITY|||||||0.75|||||||Wilcoxon (Mann-Whitney)|||||||0.75
72396655|NCT02756689|144299169|SUPERIORITY|||||||0.75|||||||Wilcoxon (Mann-Whitney)|||||||0.75
72396656|NCT02756689|144299170|SUPERIORITY|||||||0.29|||||||Wilcoxon (Mann-Whitney)|||||||0.29
72396657|NCT02756689|144299171|SUPERIORITY|||||||0.42|||||||Wilcoxon (Mann-Whitney)|||||||0.42
72396658|NCT02756689|144299172|SUPERIORITY|||||||0.96|||||||Wilcoxon (Mann-Whitney)|||||||0.96
72396659|NCT02756689|144299173|SUPERIORITY|||||||0.75|||||||Wilcoxon (Mann-Whitney)|||||||0.75
72396660|NCT02756689|144299174|SUPERIORITY|||||||0.57|||||||Wilcoxon (Mann-Whitney)|||||||0.57
72396661|NCT02756689|144299175|SUPERIORITY|||||||0.39|||||||Wilcoxon (Mann-Whitney)|||||||0.39
72396662|NCT02756689|144299176|SUPERIORITY|||||||0.24|||||||Wilcoxon (Mann-Whitney)|||||||0.24
72396663|NCT02756689|144299177|SUPERIORITY|||||||0.12|||||||Wilcoxon (Mann-Whitney)|||||||0.12
72396664|NCT02756689|144299178|SUPERIORITY|||||||0.06|||||||Wilcoxon (Mann-Whitney)|||||||0.06
72396665|NCT02756689|144299179|SUPERIORITY|||||||0.83|||||||Wilcoxon (Mann-Whitney)|||||||0.83
72396666|NCT02756689|144299180|SUPERIORITY|||||||0.6|||||||Wilcoxon (Mann-Whitney)|||||||0.60
72396667|NCT02237950|144299181|SUPERIORITY|||||||0.015|||||||Regression, Logistic|||||||0.015
72396668|NCT02237950|144299182|SUPERIORITY|||||||0.007|||||||Log Rank|||||||0.007
72396669|NCT02237950|144299183|SUPERIORITY|||||||0.002|||||||Regression, Logistic|||||||0.002
72396670|NCT02237950|144299184|SUPERIORITY|||||||0.014|||||||Regression, Logistic|||||||0.014
72396671|NCT02237950|144299185|SUPERIORITY|||||||0.012|||||||Regression, Logistic|||||||0.012
72396672|NCT02237950|144299186|SUPERIORITY|||||||0.059|||||||Regression, Logistic|||||||0.059
72396673|NCT02237950|144299187|SUPERIORITY|||||||0.008|||||||Regression, Logistic|||||||0.008
72396674|NCT00533845|144299196|SUPERIORITY_OR_OTHER|||||||0.0022|TWO_SIDED||||||t-test, 2 sided|||||||.0022
72396675|NCT01860651|144299201|OTHER||mean difference over time|-0.002||||0.22|TWO_SIDED|95.0|-0.005|0.001|||Mixed Effect Model|||"Statistical analysis of Medical adherence in study Medication adm. at home were analysed using a Mixed Effect Model (MEM). The MEM model included a random patient effect and a fixed effect interaction between group and time, to evaluate difference between the groups over time."||0.001|-0.005|0.22
72396676|NCT01288469|144299212|SUPERIORITY_OR_OTHER||LS Mean Difference|-55.82|||<|0.0001|TWO_SIDED|95.0|-65.62|-46.03||Threshold for significance ≤0.05.|ANCOVA||Alirocumab vs. placebo|Throughout the ANCOVA model, the Alirocumab + atorvastatin 80 mg group was compared to the placebo + atorvastatin 80 mg group using appropriate contrast and the 95% confidence interval (CI) of the difference was provided.||-46.03|-65.62|<0.0001
72396677|NCT00110149|144299223|OTHER|As the study was not able to be completed the simple number of patients per outcome is listed.|||||||||||||||||The trial was to measure the response rate and EFS of patients but the manufacturer of the investigational agent closed and sold the agent to a new company so the trial was not able to be completed.|||
72396678|NCT00563381|144299225|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.83|||<|0.0001||95.0|0.77|0.9|||Regression, Cox|Treatment effect adjusted for pooled centre||Tiotropium versus Salmeterol||0.90|0.77|<0.0001
72396679|NCT00563381|144299226|SUPERIORITY_OR_OTHER||Rate ratio (ratio of incidence rates)|0.73|STANDARD_ERROR_OF_MEAN|0.04|<|0.0001||95.0|0.66|0.82|||Poisson regression|Poisson regression correcting for overdisperion and adjusted for treatment exposure||Tiotropium vs. Salmeterol||0.82|0.66|<0.0001
72396680|NCT00563381|144299227|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.9||||0.0002||95.0|0.85|0.95|||Cochran-Mantel-Haenszel|||Tiotropium versus Salmeterol||0.95|0.85|0.0002
72396681|NCT00563381|144299228|SUPERIORITY_OR_OTHER||Rate ratio (ratio of incidence rates)|0.89|STANDARD_ERROR_OF_MEAN|0.03||0.0017||95.0|0.83|0.96|||Poisson regression|Poisson regression correcting for overdisperion and adjusted for treatment exposure||Tiotropium versus Salmeterol||0.96|0.83|0.0017
72396682|NCT00563381|144299229|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.72|||<|0.0001||95.0|0.61|0.85|||Regression, Cox|Treatment effect adjusted for pooled centre||Tiotropium versus Salmeterol||0.85|0.61|<0.0001
72396683|NCT00563381|144299230|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.77||||0.0005||95.0|0.66|0.89|||Cochran-Mantel-Haenszel|||Tiotropium versus Salmeterol||0.89|0.66|0.0005
72396684|NCT00563381|144299231|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.88||||0.0242||95.0|0.78|0.98|||Regression, Cox|Treatment effect adjusted for pooled centre||Tiotropium versus Salmeterol||0.98|0.78|0.0242
72396685|NCT00563381|144299232|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.9||||0.0406||95.0|0.82|1.0|||Cochran-Mantel-Haenszel|||Tiotropium versus Salmeterol||1.00|0.82|0.0406
72396686|NCT00563381|144299233|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.84|||<|0.0001||95.0|0.78|0.91|||Regression, Cox|Treatment effect adjusted for pooled centre||Tiotropium versus Salmeterol||0.91|0.78|<0.0001
72396687|NCT00563381|144299234|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.77|||<|0.0001||95.0|0.69|0.85|||Regression, Cox|Treatment effect adjusted for pooled centre||Tiotropium versus Salmeterol||0.85|0.69|<0.0001
72396688|NCT00563381|144299235|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.85|||<|0.0001||95.0|0.78|0.92|||Regression, Cox|Treatment effect adjusted for pooled centre||Tiotropium versus Salmeterol||0.92|0.78|<0.0001
72396689|NCT00563381|144299236|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.76|||<|0.0001||95.0|0.68|0.86|||Regression, Cox|Treatment effect adjusted for pooled centre||Tiotropium versus Salmeterol||0.86|0.68|<0.0001
72396690|NCT00563381|144299237|SUPERIORITY_OR_OTHER||Rate ratio (ratio of incidence rates)|0.82|STANDARD_ERROR_OF_MEAN|0.04|<|0.0001||95.0|0.76|0.9|||Poisson regression|Poisson regression correcting for overdispersion and adjusted for treatment exposure||Tiotropium versus Salmeterol||0.90|0.76|<0.0001
72396691|NCT00563381|144299238|SUPERIORITY_OR_OTHER||Rate ratio (ratio of incidence rates)|0.9|STANDARD_ERROR_OF_MEAN|0.03||0.0036||95.0|0.84|0.97|||Poisson regression|Poisson regression correcting for overdisperion and adjusted for treatment exposure||Tiotropium versus Salmeterol||0.97|0.84|0.0036
72396692|NCT00563381|144299239|SUPERIORITY_OR_OTHER||Rate ratio (ratio of incidence rates)|0.8|STANDARD_ERROR_OF_MEAN|0.04|<|0.0001||95.0|0.73|0.88|||Poisson regression|Poisson regression correcting for overdisperion and adjusted for treatment exposure||Tiotropium versus Salmeterol||0.88|0.73|<0.0001
72396693|NCT00563381|144299240|SUPERIORITY_OR_OTHER||difference in peak expiratory flow rates|-1.6||||0.1035||95.0|-3.53|0.33|||Mixed Effects Repeated Measures Model|Mixed effects repeated measures model (MMRM) (fixed terms: treatment, centre, week, treatment\*week; covariates: baseline PEFR, baseline PEFR\*week)||Tiotropium versus Salmeterol||0.33|-3.53|0.1035
72396694|NCT00563381|144299241|SUPERIORITY_OR_OTHER||difference in peak expiratory flow rates|-2.06||||0.0369||95.0|-3.99|-0.12|||Mixed Effects Repeated Measures Model|Mixed effects repeated measures model (MRMM)(fixed terms: treatment, centre, week, treatment\*week; covariates: baseline PEFR, baseline PEFR\*week).||Tiotropium versus Salmeterol||-0.12|-3.99|0.0369
72396695|NCT00563381|144299242|SUPERIORITY_OR_OTHER||difference in peak expiratory flow rates|-2.07||||0.0362||95.0|-4.0|-0.13|||Mixed Effects Repeated Measures Model|MMRM (fixed terms: treatment, centre, week, treatment\*week; covariates: baseline PEFR, baseline PEFR\*week)||Tiotropium versus Salmeterol||-0.13|-4.00|0.0362
72396696|NCT00563381|144299243|SUPERIORITY_OR_OTHER||difference in peak expiratory flow rates|-1.88||||0.0573||95.0|-3.82|0.06|||Mixed Effects Repeated Measures Model|MMRM (fixed terms: treatment, centre, week, treatment\*week; covariates: baseline PEFR, baseline PEFR\*week)||Tiotropium versus Salmeterol||0.06|-3.82|0.0573
72396697|NCT00563381|144299244|SUPERIORITY_OR_OTHER||difference in peak expiratory flow rates|-1.1||||0.2641||95.0|-3.04|0.83|||Mixed Effects Repeated Measures Model|MMRM (fixed terms: treatment, centre, week, treatment\*week; covariates: baseline PEFR, baseline PEFR\*week)||Tiotropium versus Salmeterol||0.83|-3.04|0.2641
72396698|NCT00563381|144299245|SUPERIORITY_OR_OTHER||difference in peak expiratory flow rates|-1.01||||0.3068||95.0|-2.95|0.93|||Mixed Effects Repeated Measures Model|MMRM (fixed terms: treatment, centre, week, treatment\*week; covariates: baseline PEFR, baseline PEFR\*week)||Tiotropium versus Salmeterol||0.93|-2.95|0.3068
72506028|NCT00638846|144543620|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.368|STANDARD_ERROR_OF_MEAN|0.1331|||TWO_SIDED|97.4|0.07001|0.368|||Mixed Models Analysis||The mean difference is calculated as senofilcon A toric minus balafilcon A toric.|Alternative hypothesis is that senofilcon A is superior to balafilcon A.||0.3680|0.07001|
72396699|NCT00563381|144299246|SUPERIORITY_OR_OTHER||difference in peak expiratory flow rates|-0.78||||0.4299||95.0|-2.72|1.16|||Mixed Effects Repeated Measures Model|MMRM (fixed terms: treatment, centre, week, treatment\*week; covariates: baseline PEFR, baseline PEFR\*week)||Tiotropium versus Salmeterol||1.16|-2.72|0.4299
72396700|NCT00563381|144299247|SUPERIORITY_OR_OTHER||difference in peak expiratory flow rates|-0.48||||0.6277||95.0|-2.42|1.46|||Mixed Effects Repeated Measures Model|MMRM (fixed terms: treatment, centre, week, treatment\*week; covariates: baseline PEFR, baseline PEFR\*week)||Tiotropium versus Salmeterol||1.46|-2.42|0.6277
72396701|NCT00563381|144299248|SUPERIORITY_OR_OTHER||difference in peak expiratory flow rates|-0.85||||0.3931||95.0|-2.8|1.1|||Mixed Effects Repeated Measures Model|MMRM (fixed terms: treatment, centre, week, treatment\*week; covariates: baseline PEFR, baseline PEFR\*week)||Tiotropium versus Salmeterol||1.10|-2.80|0.3931
72396702|NCT00563381|144299249|SUPERIORITY_OR_OTHER||difference in peak expiratory flow rates|-0.97||||0.3297||95.0|-2.92|0.98|||Mixed Effects Repeated Measures Model|MMRM (fixed terms: treatment, centre, week, treatment\*week; covariates: baseline PEFR, baseline PEFR\*week)||Tiotropium versus Salmeterol||0.98|-2.92|0.3297
72396703|NCT00563381|144299250|SUPERIORITY_OR_OTHER||difference in peak expiratory flow rates|-1.3||||0.1904||95.0|-3.25|0.65|||Mixed Effects Repeated Measures Model|MMRM (fixed terms: treatment, centre, week, treatment\*week; covariates: baseline PEFR, baseline PEFR\*week)||Tiotropium versus Salmeterol||0.65|-3.25|0.1904
72396704|NCT00563381|144299251|SUPERIORITY_OR_OTHER||difference in peak expiratory flow rates|-0.99||||0.3172||95.0|-2.94|0.95|||Mixed Effects Repeated Measures Model|MMRM (fixed terms: treatment, centre, week, treatment\*week; covariates: baseline PEFR, baseline PEFR\*week)||Tiotropium versus Salmeterol||0.95|-2.94|0.3172
72396705|NCT00563381|144299252|SUPERIORITY_OR_OTHER||difference in peak expiratory flow rates|-0.67||||0.5017||95.0|-2.62|1.28|||Mixed Effects Repeated Measures Model|MMRM (fixed terms: treatment, centre, week, treatment\*week; covariates: baseline PEFR, baseline PEFR\*week)||Tiotropium versus Salmeterol||1.28|-2.62|0.5017
72396706|NCT00563381|144299253|SUPERIORITY_OR_OTHER||difference in peak expiratory flow rates|-1.23||||0.2174||95.0|-3.18|0.72|||Mixed Effects Repeated Measures Model|MMRM (fixed terms: treatment, centre, week, treatment\*week; covariates: baseline PEFR, baseline PEFR\*week)||Tiotropium versus Salmeterol||0.72|-3.18|0.2174
72396707|NCT00563381|144299254|SUPERIORITY_OR_OTHER||difference in peak expiratory flow rates|-1.1||||0.2682||95.0|-3.05|0.85|||Mixed Effects Repeated Measures Model|MMRM (fixed terms: treatment, centre, week, treatment\*week; covariates: baseline PEFR, baseline PEFR\*week)||Tiotropium versus Salmeterol||0.85|-3.05|0.2682
72565696|NCT02709486|144662693|SUPERIORITY||Odds Ratio (OR)|1.91||||0.002|TWO_SIDED|95.0|1.27|2.87|||Regression, Logistic|||Week 4, \>=50%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.87|1.27|0.0020
72396708|NCT00563381|144299255|SUPERIORITY_OR_OTHER||difference in peak expiratory flow rates|-0.59||||0.552||95.0|-2.55|1.36|||Mixed Effects Repeated Measures Model|MMRM (fixed terms: treatment, centre, week, treatment\*week; covariates: baseline PEFR, baseline PEFR\*week)||Tiotropium versus Salmeterol||1.36|-2.55|0.5520
72396709|NCT01911689|144299256|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||t-test, 2 sided|||The independent T test was used to determine the differences for the T2\* value between the Control group and AP group.||||<0.01
72396710|NCT01911689|144299257|SUPERIORITY_OR_OTHER|||||||0.05|TWO_SIDED|95.0|||||t-test, 2 sided|||The independent T test was used to determine the differences for the T2\* value between the edematous AP and necrotizing AP||||0.05
72396711|NCT01911689|144299258|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED|95.0|||||ANOVA|||Analysis of variance (ANOVA) was used to assess the differences in the T2\* value between the mild, moderate, and severe AP groups according to the MRSI score.||||<0.01
72396712|NCT01911689|144299258|SUPERIORITY_OR_OTHER|||||||0.0111|TWO_SIDED|95.0|||||t-test, 2 sided|||compare the T2\* value in the mild and moderate AP according to MRSI||||0.0111
72396713|NCT01911689|144299258|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED|95.0|||||t-test, 2 sided|||compare the T2\* value between the mild and severe AP||||0.002
72396714|NCT01911689|144299258|SUPERIORITY_OR_OTHER|||||||0.071|TWO_SIDED|95.0|||||t-test, 2 sided|||compare the T2\* value between the moderate and severe AP according to MRSI||||0.071
72396715|NCT01911689|144299259|SUPERIORITY_OR_OTHER|||||||0.629|TWO_SIDED|95.0|||||t-test, 2 sided|||||||0.629
72396716|NCT00560859|144299280|SUPERIORITY_OR_OTHER||difference of change from baseline|2.0||||0.16|||||||ANCOVA|||||||0.16
72396717|NCT00824512|144299327|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9133|TWO_SIDED|95.0||||No multiplicity adjustment performed for this study and all statistical tests are two-sided at the 5% significance level.|Non parametric ANCOVA on the rank test|The baseline value was used as a covariate.||||||0.9133
72396718|NCT00071513|144299353|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||Mean changes in Short Moods and Feelings measure of depression was the unit of analysis.||||<0.05
72396719|NCT00071513|144299353|SUPERIORITY_OR_OTHER||||||<|0.01|||||||t-test, 2 sided|||A secondary hypothesis of the study was that attachment to school and/or perceptions of school supportiveness would mediate the effect of the HSTS intervention on depressive symptoms.||||<0.01
72396720|NCT02260921|144299364|SUPERIORITY||Difference in Least Squares (LS) Means|-7.53||||0.0002|TWO_SIDED|95.0|-11.48|-3.58||P-values are obtained by fitting an ANCOVA model with treatment as factor and WOMAC baseline pain score as a covariate.|ANCOVA||LS estimates are obtained by fitting an ANCOVA model with treatment as factor and WOMAC baseline pain score as a covariate.|||-3.58|-11.48|0.0002
72396721|NCT01846611|144299381|SUPERIORITY||Hazard Ratio (HR)|0.925|||=|0.5236|TWO_SIDED|95.0|0.727|1.177|||Unstratified log rank test|||||1.177|0.727|= 0.5236
72396722|NCT01846611|144299382|SUPERIORITY||Hazard Ratio (HR)|0.935|||=|0.5174|TWO_SIDED|95.0|0.762|1.147|||Unstratified log rank test|||||1.147|0.762|= 0.5174
72396723|NCT01846611|144299383|SUPERIORITY||Odds Ratio (OR)|1.523|||=|0.0142|TWO_SIDED|95.0|1.075|2.158|||Fisher Exact|||||2.158|1.075|= 0.0142
72396724|NCT02879305|144299392|NON_INFERIORITY|Non-inferiority was achieved if the upper limit of the two-sided 95% CI for the hazard ratio was below the pre-specified non-inferiority margin of 1.25.|Hazard Ratio (HR)|0.93|||||TWO_SIDED|95.0|0.81|1.07|||||Hazard ratio was estimated using a Cox proportional hazard regression model with treatment group, dialysis type and region as covariates.|||1.07|0.81|
72396725|NCT02879305|144299393|NON_INFERIORITY|Non-inferiority was to be established if the lower limit of the two-sided 95% CI for the treatment difference was greater than -0.75 g/dL.|Least square (LS) mean difference|0.18|||||TWO_SIDED|95.0|0.12|0.24|||||Analysis of covariance (ANCOVA) model adjusted for treatment, Baseline Hgb, dialysis type and region along with 95% CI for treatment difference (daprodustat-rhEPO).|||0.24|0.12|
72396726|NCT02879305|144299394|SUPERIORITY||Hazard Ratio (HR)|0.93||||0.156123|TWO_SIDED|95.0|0.81|1.07||The p-value was compared against 0.0125 based on the Holm-Bonferonni adjustment.|Wald test||Hazard ratio was estimated using a Cox proportional hazard regression model with treatment group, dialysis type and region as covariates.|||1.07|0.81|0.156123
72396727|NCT02879305|144299395|SUPERIORITY||Hazard Ratio (HR)|0.88||||0.023539|TWO_SIDED|95.0|0.78|1.0||The p-value was compared against 0.006250 based on the Holm-Bonferonni adjustment.|Wald test||Hazard ratio was estimated using a Cox proportional hazard regression model with treatment group, dialysis type and region as covariates.|||1.00|0.78|0.023539
72396728|NCT02879305|144299396|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.325797|TWO_SIDED|95.0|0.85|1.11||The p-value was compared against 0.025000 based on the Holm-Bonferonni adjustment.|Wald test||Hazard ratio was estimated using a Cox proportional hazard regression model with treatment group, dialysis type and region as covariates.|||1.11|0.85|0.325797
72622926|NCT05430919|144775965|SUPERIORITY||LS Mean Difference|-63.18|||<|0.0001|TWO_SIDED|95.0|-73.411|-52.95|||ANCOVA||REGN5713-5714-5715 900 mg vs. Placebo, Day 29|||-52.950|-73.411|<0.0001
72622927|NCT05430919|144775965|SUPERIORITY||LS Mean Difference|-56.01|||<|0.0001|TWO_SIDED|95.0|-66.806|-45.204|||ANCOVA||REGN5713-5715 600 mg vs. Placebo, Day 29|||-45.204|-66.806|<0.0001
72471657|NCT00474526|144466762|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA3 over LA4, the lower limit of the two-sided 95% CI for the difference in seroresponse rates (PLA3 - PLA4) must be greater than 5% for poliovirus and greater than -10% for all other antigens.|Seroconversion Percentage difference|0.0|||||TWO_SIDED|95.0|-2.0|4.7|||ANOVA|||Polio Type 1 (Seroconversion percentage difference (PLA3 - PLA4))||4.7|-2|
72471658|NCT00474526|144466762|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA3 over LA4, the lower limit of the two-sided 95% CI for the difference in seroresponse rates (PLA3 - PLA4) must be greater than 5% for poliovirus and greater than -10% for all other antigens.|Seroconversion Percentage difference|0.0|||||TWO_SIDED|95.0|-3.0|4.8|||ANOVA|||Polio Type 2 (Seroconversion percentage difference (PLA3 - PLA4))||4.8|-3|
72471659|NCT00474526|144466762|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA3 over LA4, the lower limit of the two-sided 95% CI for the difference in seroresponse rates (PLA3 - PLA4) must be greater than 5% for poliovirus and greater than -10% for all other antigens.|Seroconversion Percentage difference|-1.0|||||TWO_SIDED|95.0|-4.4|4.5|||ANOVA|||Polio Type 3 (Seroconversion percentage difference (PLA3 - PLA4))||4.5|-4.4|
72396729|NCT02879305|144299397|SUPERIORITY||LS mean difference|-9.1||||0.026947|TWO_SIDED|95.0|-18.4|0.2||The p-value was compared against 0.008333 based on the Holm-Bonferonni adjustment.|ANCOVA||Analysis was carried out by using ANCOVA model with terms for treatment, Baseline monthly IV iron dose, dialysis type and region.|||0.2|-18.4|0.026947
72471660|NCT00474526|144466762|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA3 over LA4, the lower limit of the two-sided 95% CI for the difference in seroresponse rates (PLA3 - PLA4) must be greater than 5% for poliovirus and greater than -10% for all other antigens.|Seroconversion Percentage difference|0.0|||||TWO_SIDED|95.0|-2.3|2.7|||ANOVA|||Hepatitis B (Seroconversion percentage difference (PLA3 - PLA4))||2.7|-2.3|
72396730|NCT02879305|144299398|SUPERIORITY||Hazard Ratio (HR)|0.96||||0.3281|TWO_SIDED|95.0|0.82|1.13|||Wald test||Hazard ratio was estimated using a Cox proportional hazard regression model with treatment group, dialysis type and region as covariates.|||1.13|0.82|0.3281
72396731|NCT02879305|144299399|SUPERIORITY||Hazard Ratio (HR)|0.95||||0.3553|TWO_SIDED|95.0|0.74|1.23|||Wald test||Hazard ratio was estimated using a Cox proportional hazard regression model with treatment group, dialysis type and region as covariates.|||1.23|0.74|0.3553
72396732|NCT02879305|144299400|SUPERIORITY||Hazard Ratio (HR)|0.81||||0.0524|TWO_SIDED|95.0|0.63|1.04|||Wald test||Hazard ratio was estimated using a Cox proportional hazard regression model with treatment group, dialysis type and region as covariates.|||1.04|0.63|0.0524
72396733|NCT02879305|144299401|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.1927|TWO_SIDED|95.0|0.56|1.25|||Wald test||Hazard ratio was estimated using a Cox proportional hazard regression model with treatment group, dialysis type and region as covariates.|||1.25|0.56|0.1927
72471661|NCT00474526|144466762|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA3 over LA4, the lower limit of the two-sided 95% CI for the difference in seroresponse rates (PLA3 - PLA4) must be greater than 5% for poliovirus and greater than -10% for all other antigens.|Seroconversion Percentage difference|-2.0|||||TWO_SIDED|95.0|-5.3|1.0|||ANOVA|||Hib (≥ 0.15 μg/mL)(Seroconversion percentage difference (PLA3 - PLA4))||1|-5.3|
72396734|NCT02879305|144299402|SUPERIORITY||Hazard Ratio (HR)|0.9||||0.0351|TWO_SIDED|95.0|0.8|1.01|||Chi-squared||Overall HR is presented using Model 1. Model 1 assumed a common treatment effect, regardless of number of events experienced. HR was estimated using a Prentice, Williams and Peterson(PWP) model, with treatment, dialysis type and region as covariates.|||1.01|0.80|0.0351
72471662|NCT00474526|144466762|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA3 over LA4, the lower limit of the two-sided 95% CI for the difference in seroresponse rates (PLA3 - PLA4) must be greater than 5% for poliovirus and greater than -10% for all other antigens.|Seroconversion Percentage difference|-2.0||||||95.0|-6.6|3.0|||ANOVA|||Hib (≥1.0 μg/mL)(Seroconversion percentage difference (PLA3 - PLA4))||3|-6.6|
72471663|NCT00474526|144466762|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA3 over LA4, the lower limit of the two-sided 95% CI for the difference in seroresponse rates (PLA3 - PLA4) must be greater than 5% for poliovirus and greater than -10% for all other antigens.|Seroconversion Percentage difference|-1.0|||||TWO_SIDED|95.0|-4.2|3.0|||ANOVA|||PnC 4 (Seroconversion percentage difference (PLA3 - PLA4))||3|-4.2|
72506029|NCT00638846|144543621|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin is -0.4.|Mean Difference (Final Values)|-0.0688|STANDARD_ERROR_OF_MEAN|0.1648|||TWO_SIDED|97.5|-0.0688|-0.0197|||Mixed Models Analysis||The mean difference is calculated as senofilcon A toric minus balafilcon A toric.|Alternative hypothesis is that senofilcon A toric is superior to balafilcon A toric by having a lower grade fo corneal staining.||-0.0197|-0.0688|
72396735|NCT02879305|144299402|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.3258|TWO_SIDED|95.0|0.85|1.11|||Chi-squared||First Event Hazard ratio is presented using Model 2. Model 2 assumed treatment effect differs by number of events experienced. Hazard Ratio (HR) was estimated using a PWP model, with treatment, dialysis type and region as covariates.|||1.11|0.85|0.3258
72396736|NCT02879305|144299402|SUPERIORITY||Hazard Ratio (HR)|0.75||||0.0158|TWO_SIDED|95.0|0.58|0.98|||Chi-squared||Second Event Hazard ratio is presented using Model 2. Model 2 assumed treatment effect differs by number of events experienced. HR was estimated using a PWP model, with treatment, dialysis type and region as covariates.|||0.98|0.58|0.0158
72622928|NCT05430919|144775965|SUPERIORITY||LS Mean Difference|-34.82|||<|0.0001|TWO_SIDED|95.0|-45.304|-24.343|||ANCOVA||REGN5715 300 mg vs. Placebo, Day 29|||-24.343|-45.304|<0.0001
72396737|NCT02879305|144299402|SUPERIORITY||Hazard Ratio (HR)|0.74||||0.0981|TWO_SIDED|95.0|0.47|1.17|||Chi-squared||Third Event Hazard ratio is presented using Model 2. Model 2 assumed treatment effect differs by number of events experienced. HR was estimated using a PWP model, with treatment, dialysis type and region as covariates.|||1.17|0.47|0.0981
72471664|NCT00474526|144466762|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA3 over LA4, the lower limit of the two-sided 95% CI for the difference in seroresponse rates (PLA3 - PLA4) must be greater than 5% for poliovirus and greater than -10% for all other antigens.|Seroconversion Percentage difference|2.0|||||TWO_SIDED|95.0|-4.0|9.0|||ANOVA|||PnC 6B (Seroconversion percentage difference (PLA3 - PLA4))||9|-4|
72471665|NCT00474526|144466762|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA3 over LA4, the lower limit of the two-sided 95% CI for the difference in seroresponse rates (PLA3 - PLA4) must be greater than 5% for poliovirus and greater than -10% for all other antigens.|Seroconversion Percentage difference|1.0|||||TWO_SIDED|95.0|-2.8|6.0|||ANOVA|||PnC 9V (Seroconversion percentage difference (PLA3 - PLA4))||6|-2.8|
72396738|NCT02879305|144299402|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.3258|TWO_SIDED|95.0|0.85|1.11|||Chi-squared||First Event Hazard ratio is presented using Model 3. Model 3 assumed treatment effect for first event differs from a common effect for subsequent events. HR was estimated using a PWP model, with treatment, dialysis type and region as covariates.|||1.11|0.85|0.3258
72396739|NCT02879305|144299402|SUPERIORITY||Hazard Ratio (HR)|0.75||||0.0058|TWO_SIDED|95.0|0.6|0.94|||Chi-squared||Subsequent Event Hazard ratio is presented using Model 3. Model 3 assumed treatment effect for first event differs from a common effect for subsequent events. HR was estimated using a PWP model, with treatment, dialysis type and region as covariates.|||0.94|0.60|0.0058
72396740|NCT02879305|144299403|SUPERIORITY||Hazard Ratio (HR)|0.88||||0.0872|TWO_SIDED|95.0|0.73|1.06|||Wald test||Hazard ratio was estimated using a Cox proportional hazard regression model with treatment group, dialysis type and region as covariates.|||1.06|0.73|0.0872
72396741|NCT02879305|144299404|SUPERIORITY||Hazard Ratio (HR)|0.95||||0.154|TWO_SIDED|95.0|0.87|1.04|||Wald test||Hazard ratio was estimated using a Cox proportional hazard regression model with treatment group, dialysis type and region as covariates.|||1.04|0.87|0.1540
72396742|NCT02879305|144299405|SUPERIORITY||Hazard Ratio (HR)|0.91||||0.1244|TWO_SIDED|95.0|0.77|1.07|||Wald test||Hazard ratio was estimated using a Cox proportional hazard regression model with treatment group, dialysis type and region as covariates.|||1.07|0.77|0.1244
72396743|NCT02879305|144299406|SUPERIORITY||Hazard Ratio (HR)|0.91||||0.054|TWO_SIDED|95.0|0.81|1.02|||Wald test||Hazard ratio was estimated using a Cox proportional hazard regression model with treatment group, dialysis type and region as covariates.|||1.02|0.81|0.0540
72396744|NCT02879305|144299407|SUPERIORITY||Hazard Ratio (HR)|1.1||||0.7658|TWO_SIDED|95.0|0.84|1.45|||Wald test||Hazard ratio was estimated using a Cox proportional hazard regression model with treatment group, dialysis type and region as covariates.|||1.45|0.84|0.7658
72396745|NCT02879305|144299408|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.0425|TWO_SIDED|95.0|0.69|1.02|||Wald test||Hazard ratio was estimated using a Cox proportional hazard regression model with treatment group, dialysis type and region as covariates.|||1.02|0.69|0.0425
72396746|NCT02879305|144299409|NON_INFERIORITY|Non-inferiority was to be established if the lower limit of the two-sided 95% CI for the treatment difference was greater than the pre-specified non-inferiority margin of -0.75 g/dL.|LS mean difference|0.12|||||TWO_SIDED|95.0|0.03|0.21||||||||0.21|0.03|
72396747|NCT02879305|144299410|SUPERIORITY||Difference in response rate|3.5||||0.0367|TWO_SIDED|95.0|-0.1|7.1|||Cochran-Mantel-Haenszel||Cochran-Mantel-Haenszel (CMH) test adjusted for dialysis type, and region was used to compare the number of responders between the treatment groups.|||7.1|-0.1|0.0367
72396748|NCT02879305|144299411|NON_INFERIORITY|Non-inferiority was to be established if the lower limit of the two-sided 95% confidence interval for the treatment difference was greater than non-inferiority margin of -15%.|Median Difference (Final Values)|1.06|||||TWO_SIDED|95.0|0.0|3.86|||||Hodges-Lehmann estimate of the treatment difference (daprodustat-rhEPO) and associated two-sided asymptotic 95% CI is presented.|||3.86|0.00|
72396749|NCT02879305|144299412|SUPERIORITY||Probability|0.52||||0.0805|TWO_SIDED|95.0|0.49|0.54|||van Elteren test||Mann-Whitney estimate (Probability) of the treatment effect has been presented.|||0.54|0.49|0.0805
72396750|NCT02879305|144299413|NON_INFERIORITY|Non-inferiority was to be established if the lower limit of the two-sided 95% confidence interval for the treatment difference was greater than non-inferiority margin of -15%.|Median Difference (Final Values)|2.18|||||TWO_SIDED|95.0|0.28|4.05|||||Hodges-Lehmann estimate of the treatment difference (daprodustat-rhEPO) and associated two-sided asymptotic 95% CI is presented.|||4.05|0.28|
72396751|NCT02879305|144299414|SUPERIORITY||Probability|0.53||||0.0139|TWO_SIDED|95.0|0.5|0.55|||van Elteren test||Mann-Whitney estimate (Probability) of the treatment effect has been presented.|||0.55|0.50|0.0139
72396752|NCT02879305|144299415|SUPERIORITY||LS mean difference|0.33||||0.6551|TWO_SIDED|95.0|-1.28|1.94|||MMRM||The difference in change from Baseline in SBP at Week 52 was analyzed with a MMRM approach with an unstructured covariance matrix to compare the difference in means between arms.|||1.94|-1.28|0.6551
72396753|NCT02879305|144299415|SUPERIORITY||LS mean difference|-0.46||||0.1586|TWO_SIDED|95.0|-1.36|0.44|||MMRM||The difference in change from Baseline in DBP at Week 52 was analyzed with a MMRM approach with an unstructured covariance matrix to compare the difference in means between arms.|||0.44|-1.36|0.1586
72396754|NCT02879305|144299415|SUPERIORITY||LS mean difference|-0.18||||0.3646|TWO_SIDED|95.0|-1.2|0.84|||MMRM||The difference in change from Baseline in MAP at Week 52 was analyzed with a MMRM approach with an unstructured covariance matrix to compare the difference in means between arms.|||0.84|-1.20|0.3646
72396755|NCT02879305|144299416|SUPERIORITY||LS mean difference|0.0||||0.5012|TWO_SIDED|95.0|-1.54|1.54|||ANCOVA||For SBP: Treatment group comparisons were based on an ANCOVA model with terms for treatment group, dialysis type, region and Baseline value.|||1.54|-1.54|0.5012
72396756|NCT02879305|144299416|SUPERIORITY||LS mean difference|0.45||||0.8451|TWO_SIDED|95.0|-0.42|1.31|||ANCOVA||For DBP: Treatment group comparisons were based on an ANCOVA model with terms for treatment group, dialysis type, region and Baseline value.|||1.31|-0.42|0.8451
72396757|NCT02879305|144299416|SUPERIORITY||LS mean difference|0.31||||0.7312|TWO_SIDED|95.0|-0.67|1.28|||ANCOVA||For MAP: Treatment group comparisons were based on an ANCOVA model with terms for treatment group, dialysis type, region and Baseline value.|||1.28|-0.67|0.7312
72396758|NCT02879305|144299417|SUPERIORITY||Ratio of exacerbation rate|1.0||||0.529|TWO_SIDED|95.0|0.91|1.11|||Negative binomial model||Ratio of model estimated exacerbation rates and CIs were estimated using a negative binomial model for the treatment group comparison.|||1.11|0.91|0.5290
72396759|NCT02879305|144299419|SUPERIORITY||Hazard Ratio (HR)|1.04||||0.5772|TWO_SIDED|95.0|0.71|1.52|||Wald test||Hazard ratio was estimated using a Cox proportional hazard regression model adjusted for treatment group, dialysis type and region.|||1.52|0.71|0.5772
72396760|NCT02879305|144299420|SUPERIORITY||LS mean difference|0.29||||0.162|TWO_SIDED|95.0|-0.29|0.86|||MMRM||Week 8: Model was fitted from Baseline up to Week 52 and the model adjusted Week 8 data has been presented, with factors for treatment, time, dialysis type, region, Baseline value and Baseline value by time and treatment by time interactions.|||0.86|-0.29|0.1620
72396761|NCT02879305|144299420|SUPERIORITY||LS mean difference|0.61||||0.018|TWO_SIDED|95.0|0.04|1.18|||MMRM||Week 12: Model was fitted from Baseline up to Week 52 and the model adjusted Week 12 data has been presented, with factors for treatment, time, dialysis type, region, Baseline value and Baseline value by time and treatment by time interactions.|||1.18|0.04|0.0180
72396762|NCT02879305|144299420|SUPERIORITY||LS mean difference|0.33||||0.153|TWO_SIDED|95.0|-0.31|0.97|||MMRM||Week 28: Model was fitted from Baseline up to Week 52 and the model adjusted Week 28 data has been presented, with factors for treatment, time, dialysis type, region, Baseline value and Baseline value by time and treatment by time interactions.|||0.97|-0.31|0.1530
72396763|NCT02879305|144299420|SUPERIORITY||LS mean difference|0.53||||0.0686|TWO_SIDED|95.0|-0.17|1.22|||MMRM||Week 52: Model was fitted from Baseline up to Week 52 and the model adjusted Week 52 data has been presented, with factors for treatment, time, dialysis type, region, Baseline value and Baseline value by time and treatment by time interactions.|||1.22|-0.17|0.0686
72396764|NCT02879305|144299421|SUPERIORITY||LS mean difference|-0.17||||0.6807|TWO_SIDED|95.0|-0.88|0.54|||MMRM||Week 8: Model was fitted from Baseline up to Week 52 and the model adjusted Week 8 data has been presented, with factors for treatment, time, dialysis type, region, Baseline value and Baseline value by time and treatment by time interactions.|||0.54|-0.88|0.6807
72396765|NCT02879305|144299421|SUPERIORITY||LS mean difference|0.17||||0.3256|TWO_SIDED|95.0|-0.57|0.91|||MMRM||Week 12: Model was fitted from Baseline up to Week 52 and the model adjusted Week 12 data has been presented, with factors for treatment, time, dialysis type, region, Baseline value and Baseline value by time and treatment by time interactions.|||0.91|-0.57|0.3256
72396766|NCT02879305|144299421|SUPERIORITY||LS mean difference|-0.01||||0.5144|TWO_SIDED|95.0|-0.81|0.78|||MMRM||Week 28: Model was fitted from Baseline up to Week 52 and the model adjusted Week 28 data has been presented, with factors for treatment, time, dialysis type, region, Baseline value and Baseline value by time and treatment by time interactions.|||0.78|-0.81|0.5144
72396767|NCT02879305|144299421|SUPERIORITY||LS mean difference|-0.6||||0.912|TWO_SIDED|95.0|-1.47|0.27|||MMRM||Week 52: Model was fitted from Baseline up to Week 52 and the model adjusted Week 52 data has been presented, with factors for treatment, time, dialysis type, region, Baseline value and Baseline value by time and treatment by time interactions.|||0.27|-1.47|0.9120
72396768|NCT02879305|144299422|SUPERIORITY||LS mean difference|-0.25||||0.7432|TWO_SIDED|95.0|-0.99|0.5|||MMRM||Bodily pain,Week8: Model was fitted from Baseline up to Week52 and model adjusted Week8 data has been presented, with factors for treatment, time, dialysis type, region, Baseline value and Baseline value by time and treatment by time interactions.|||0.50|-0.99|0.7432
72396769|NCT02879305|144299422|SUPERIORITY||LS mean difference|0.58||||0.0631|TWO_SIDED|95.0|-0.16|1.33|||MMRM||Bodily pain,Week12: Model was fitted from Baseline up to Week52 and model adjusted Week12 data has been presented, with factors for treatment, time, dialysis type, region, Baseline value and Baseline value by time and treatment by time interactions.|||1.33|-0.16|0.0631
72396770|NCT02879305|144299422|SUPERIORITY||LS mean difference|0.04||||0.4604|TWO_SIDED|95.0|-0.79|0.87|||MMRM||Bodily pain,Week28: Model was fitted from Baseline up to Week52 and model adjusted Week28 data has been presented, with factors for treatment, time, dialysis type, region, Baseline value and Baseline value by time and treatment by time interactions.|||0.87|-0.79|0.4604
72396771|NCT02879305|144299422|SUPERIORITY||LS mean difference|0.28||||0.2688|TWO_SIDED|95.0|-0.6|1.15|||MMRM||Bodily pain,Week52: Model was fitted from Baseline up to Week52 and model adjusted Week52 data has been presented, with factors for treatment, time, dialysis type, region, Baseline value and Baseline value by time and treatment by time interactions.|||1.15|-0.60|0.2688
72396772|NCT02879305|144299422|SUPERIORITY||LS mean difference|0.26||||0.1918|TWO_SIDED|95.0|-0.32|0.84|||MMRM||General health,Week8:Model was fitted from Baseline up to Week52 and model adjusted Week8 data has been presented, with factors for treatment, time, dialysis type, region, Baseline value and Baseline value by time and treatment by time interactions.|||0.84|-0.32|0.1918
72396773|NCT02879305|144299422|SUPERIORITY||LS mean difference|0.45||||0.0677|TWO_SIDED|95.0|-0.14|1.04|||MMRM||General health,Week12:Model was fitted from Baseline up to Week52 and model adjusted Week12 data has been presented, with factors for treatment, time, dialysis type, region,Baseline value and Baseline value by time and treatment by time interactions.|||1.04|-0.14|0.0677
72396774|NCT02879305|144299422|SUPERIORITY||LS mean difference|-0.33||||0.8386|TWO_SIDED|95.0|-0.98|0.32|||MMRM||General health,Week28:Model was fitted from Baseline up to Week52 and model adjusted Week28 data has been presented, with factors for treatment, time, dialysis type, region,Baseline value and Baseline value by time and treatment by time interactions.|||0.32|-0.98|0.8386
72396775|NCT02879305|144299422|SUPERIORITY||LS mean difference|-0.29||||0.7928|TWO_SIDED|95.0|-0.99|0.41|||MMRM||General health,Week52:Model was fitted from Baseline up to Week52 and model adjusted Week52 data has been presented, with factors for treatment, time, dialysis type, region,Baseline value and Baseline value by time and treatment by time interactions.|||0.41|-0.99|0.7928
72471666|NCT00474526|144466762|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA3 over LA4, the lower limit of the two-sided 95% CI for the difference in seroresponse rates (PLA3 - PLA4) must be greater than 5% for poliovirus and greater than -10% for all other antigens.|Seroconversion Percentage difference|-1.0|||||TWO_SIDED|95.0|-3.7|3.4|||ANOVA|||PnC 14 (Seroconversion percentage difference (PLA3 - PLA4))||3.4|-3.7|
72471667|NCT00474526|144466762|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA3 over LA4, the lower limit of the two-sided 95% CI for the difference in seroresponse rates (PLA3 - PLA4) must be greater than 5% for poliovirus and greater than -10% for all other antigens.|Seroconversion Percentage difference|-3.0|||||TWO_SIDED|95.0|-7.2|0.8|||ANOVA|||PnC 18C (Seroconversion percentage difference (PLA3 - PLA4))||0.8|-7.2|
72471668|NCT00474526|144466762|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA3 over LA4, the lower limit of the two-sided 95% CI for the difference in seroresponse rates (PLA3 - PLA4) must be greater than 5% for poliovirus and greater than -10% for all other antigens.|Seroconversion Percentage difference|2.0|||||TWO_SIDED|95.0|-0.8|7.5|||ANOVA|||PnC 19F (Seroconversion percentage difference (PLA3 - PLA4))||7.5|-0.8|
72506030|NCT00638846|144543622|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.368|STANDARD_ERROR_OF_MEAN|0.1331|||TWO_SIDED|97.4|0.07001|0.368|||Mixed Models Analysis||The mean difference is calculated as senofilcon A toric minus balafilcon A toric.|Alternative hypothesis is that senofilcon A toric is superior to balafilcon A toric.||0.3680|0.07001|
72506031|NCT02428140|144543623|SUPERIORITY||Risk Ratio (RR)|3.29||||0.003|TWO_SIDED|95.0|1.45|7.42|||t-test, 2 sided|||||7.42|1.45|0.003
72396776|NCT02879305|144299422|SUPERIORITY||LS mean difference|0.04||||0.4537|TWO_SIDED|95.0|-0.63|0.71|||MMRM||Mental health,Week8:Model was fitted from Baseline up to Week52 and model adjusted Week8 data has been presented, with factors for treatment, time, dialysis type, region, Baseline value and Baseline value by time and treatment by time interactions.|||0.71|-0.63|0.4537
72396777|NCT02879305|144299422|SUPERIORITY||LS mean difference|-0.05||||0.5548|TWO_SIDED|95.0|-0.74|0.65|||MMRM||Mental health,Week12:Model was fitted from Baseline up to Week52 and model adjusted Week12 data has been presented, with factors for treatment, time, dialysis type, region,Baseline value and Baseline value by time and treatment by time interactions.|||0.65|-0.74|0.5548
72396778|NCT02879305|144299422|SUPERIORITY||LS mean difference|0.13||||0.3626|TWO_SIDED|95.0|-0.61|0.88|||MMRM||Mental health,Week28:Model was fitted from Baseline up to Week52 and model adjusted Week28 data has been presented, with factors for treatment, time, dialysis type, region,Baseline value and Baseline value by time and treatment by time interactions.|||0.88|-0.61|0.3626
72396779|NCT02879305|144299422|SUPERIORITY||LS mean difference|-0.81||||0.9721|TWO_SIDED|95.0|-1.64|0.02|||MMRM||Mental health,Week52:Model was fitted from Baseline up to Week52 and model adjusted Week52 data has been presented, with factors for treatment, time, dialysis type, region,Baseline value and Baseline value by time and treatment by time interactions.|||0.02|-1.64|0.9721
72396780|NCT02879305|144299422|SUPERIORITY||LS mean difference|-0.09||||0.5789|TWO_SIDED|95.0|-0.96|0.78|||MMRM||Role-emotional,Week8:Model was fitted from Baseline up to Week52 and model adjusted Week8 data has been presented, with factors for treatment, time, dialysis type, region, Baseline value and Baseline value by time and treatment by time interactions.|||0.78|-0.96|0.5789
72396781|NCT02879305|144299422|SUPERIORITY||LS mean difference|0.37||||0.2054|TWO_SIDED|95.0|-0.51|1.24|||MMRM||Role-emotional,Week12:Model was fitted from Baseline up to Week52 and model adjusted Week12 data has been presented, with factors for treatment, time, dialysis type, region,Baseline value and Baseline value by time and treatment by time interactions.|||1.24|-0.51|0.2054
72396782|NCT02879305|144299422|SUPERIORITY||LS mean difference|-0.05||||0.5389|TWO_SIDED|95.0|-0.98|0.89|||MMRM||Role-emotional,Week28:Model was fitted from Baseline up to Week52 and model adjusted Week28 data has been presented, with factors for treatment, time, dialysis type, region,Baseline value and Baseline value by time and treatment by time interactions.|||0.89|-0.98|0.5389
72396783|NCT02879305|144299422|SUPERIORITY||LS mean difference|0.09||||0.4289|TWO_SIDED|95.0|-0.91|1.09|||MMRM||Role-emotional,Week52:Model was fitted from Baseline up to Week52 and model adjusted Week52 data has been presented, with factors for treatment, time, dialysis type, region,Baseline value and Baseline value by time and treatment by time interactions.|||1.09|-0.91|0.4289
72396784|NCT02879305|144299422|SUPERIORITY||LS mean difference|0.08||||0.4096|TWO_SIDED|95.0|-0.6|0.75|||MMRM||Role-physical,Week8:Model was fitted from Baseline up to Week52 and model adjusted Week8 data has been presented, with factors for treatment, time, dialysis type, region, Baseline value and Baseline value by time and treatment by time interactions.|||0.75|-0.60|0.4096
72396785|NCT02879305|144299422|SUPERIORITY||LS mean difference|0.4||||0.1196|TWO_SIDED|95.0|-0.27|1.07|||MMRM||Role-physical,Week12:Model was fitted from Baseline up to Week52 and model adjusted Week12 data has been presented, with factors for treatment, time, dialysis type, region,Baseline value and Baseline value by time and treatment by time interactions|||1.07|-0.27|0.1196
72396786|NCT02879305|144299422|SUPERIORITY||LS mean difference|0.3||||0.2093|TWO_SIDED|95.0|-0.42|1.01|||MMRM||Role-physical,Week28:Model was fitted from Baseline up to Week52 and model adjusted Week28 data has been presented, with factors for treatment, time, dialysis type, region,Baseline value and Baseline value by time and treatment by time interactions|||1.01|-0.42|0.2093
72506032|NCT02428140|144543624|SUPERIORITY||Risk Difference (RD)|10.7||||0.005|TWO_SIDED|95.0|3.4|17.9|||t-test, 2 sided|||||17.9|3.4|.005
72396787|NCT02879305|144299422|SUPERIORITY||LS mean difference|0.39||||0.1674|TWO_SIDED|95.0|-0.4|1.19|||MMRM||Role-physical,Week52:Model was fitted from Baseline up to Week52 and model adjusted Week52 data has been presented, with factors for treatment, time, dialysis type, region,Baseline value and Baseline value by time and treatment by time interactions|||1.19|-0.40|0.1674
72396788|NCT02879305|144299422|SUPERIORITY||LS mean difference|-0.14||||0.6585|TWO_SIDED|95.0|-0.82|0.54|||MMRM||Social fun, Week 8: Model was fitted from Baseline up to Week52 and model adjusted Week8 data has been presented, with factors for treatment, time, dialysis type, region, Baseline value and Baseline value by time and treatment by time interactions.|||0.54|-0.82|0.6585
72396789|NCT02879305|144299422|SUPERIORITY||LS mean difference|0.69||||0.0293|TWO_SIDED|95.0|-0.03|1.4|||MMRM||Social fun, Week 12: Model was fitted from Baseline up to Week52 and model adjusted Week12 data has been presented, with factors for treatment, time, dialysis type, region, Baseline value and Baseline value by time and treatment by time interactions.|||1.40|-0.03|0.0293
72396790|NCT02879305|144299422|SUPERIORITY||LS mean difference|0.33||||0.2057|TWO_SIDED|95.0|-0.45|1.11|||MMRM||Social fun, Week 28: Model was fitted from Baseline up to Week52 and model adjusted Week28 data has been presented, with factors for treatment, time, dialysis type, region, Baseline value and Baseline value by time and treatment by time interactions.|||1.11|-0.45|0.2057
72506033|NCT02428140|144543625|SUPERIORITY||Risk Difference (RD)|2.7||||0.28|TWO_SIDED|95.0|-1.0|6.3|||t-test, 2 sided|||||6.3|-1.0|0.28
72506034|NCT02428140|144543627|SUPERIORITY||Risk Difference (RD)|0.0|||||TWO_SIDED|95.0|-1.8|1.8||||||||1.8|-1.8|
72506035|NCT02428140|144543628|SUPERIORITY||Risk Difference (RD)|0.0|||||TWO_SIDED|95.0|-3.2|3.2||||||||3.2|-3.2|
72506036|NCT01422304|144543657|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.7|||||TWO_SIDED|95.0|0.38|1.29|||Cochran-Mantel-Haenszel||Relative risk is Sugammadex versus Usual Care|Cochran-Mantel-Haenszel method was stratified for renal function (estimated creatinine clearance \< or ≥ 60 mL/min) and prophylactic antithrombotic therapy (including low molecular weight heparin \[LMWH\], including unfractionated heparin \[UFH\], or not including either LMWH or UFH)||1.29|0.38|
72542448|NCT00106028|144614667|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.438||||0.0625|TWO_SIDED|95.0|-0.235|9.111|||ANCOVA|LS means and p-value are from ANCOVA model adjusted by baseline and fixed effects for age group, treatment and pooled center for post-baseline.||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.||9.111|-0.235|0.0625
72396791|NCT02879305|144299422|SUPERIORITY||LS mean difference|0.02||||0.4849|TWO_SIDED|95.0|-0.86|0.9|||MMRM||Social fun, Week 52: Model was fitted from Baseline up to Week52 and model adjusted Week52 data has been presented, with factors for treatment, time, dialysis type, region, Baseline value and Baseline value by time and treatment by time interactions.|||0.90|-0.86|0.4849
72396792|NCT02879305|144299423|SUPERIORITY||LS mean difference|0.03||||0.4621|TWO_SIDED|95.0|-0.58|0.64|||MMRM||Week 8: Model was fitted from Baseline up to Week 52 and model adjusted Week 8 data has been presented, with factors for treatment, time, dialysis type, region, Baseline value and Baseline value by time and treatment by time interactions.|||0.64|-0.58|0.4621
72396793|NCT02879305|144299423|SUPERIORITY||LS mean difference|0.35||||0.1439|TWO_SIDED|95.0|-0.29|0.98|||MMRM||Week 12: Model was fitted from Baseline up to Week 52 and model adjusted Week 12 data has been presented, with factors for treatment, time, dialysis type, region, Baseline value and Baseline value by time and treatment by time interactions.|||0.98|-0.29|0.1439
72396794|NCT02879305|144299423|SUPERIORITY||LS mean difference|0.24||||0.2392|TWO_SIDED|95.0|-0.43|0.92|||MMRM||Week 28: Model was fitted from Baseline up to Week 52 and model adjusted Week 28 data has been presented, with factors for treatment, time, dialysis type, region, Baseline value and Baseline value by time and treatment by time interactions.|||0.92|-0.43|0.2392
72396795|NCT02879305|144299423|SUPERIORITY||LS mean difference|-0.15||||0.6545|TWO_SIDED|95.0|-0.9|0.6|||MMRM||Week 52: Model was fitted from Baseline up to Week 52 and model adjusted Week 52 data has been presented, with factors for treatment, time, dialysis type, region, Baseline value and Baseline value by time and treatment by time interactions.|||0.60|-0.90|0.6545
72396796|NCT02879305|144299424|SUPERIORITY||LS mean difference|0.64||||0.029|TWO_SIDED|95.0|-0.02|1.31|||MMRM||Week 8: Model was fitted from Baseline up to Week 52 and model adjusted Week 8 data has been presented, with factors for treatment, time, dialysis type, region, Baseline value and Baseline value by time and treatment by time interactions.|||1.31|-0.02|0.0290
72396797|NCT02879305|144299424|SUPERIORITY||LS mean difference|0.56||||0.0509|TWO_SIDED|95.0|-0.11|1.24|||MMRM||Week 12: Model was fitted from Baseline up to Week 52 and model adjusted Week 12 data has been presented, with factors for treatment, time, dialysis type, region, Baseline value and Baseline value by time and treatment by time interactions.|||1.24|-0.11|0.0509
72396798|NCT02879305|144299424|SUPERIORITY||LS mean difference|0.77||||0.0237|TWO_SIDED|95.0|0.01|1.53|||MMRM||Week 28: Model was fitted from Baseline up to Week 52 and model adjusted Week 28 data has been presented, with factors for treatment, time, dialysis type, region, Baseline value and Baseline value by time and treatment by time interactions.|||1.53|0.01|0.0237
72396799|NCT02879305|144299424|SUPERIORITY||LS mean difference|0.58||||0.0828|TWO_SIDED|95.0|-0.24|1.39|||MMRM||Week 52: Model was fitted from Baseline up to Week 52 and model adjusted Week 52 data has been presented, with factors for treatment, time, dialysis type, region, Baseline value and Baseline value by time and treatment by time interactions.|||1.39|-0.24|0.0828
72396800|NCT02879305|144299425|SUPERIORITY||LS mean difference|0.0003||||0.4939|TWO_SIDED|95.0|-0.0326|0.0331|||MMRM||MMRM model was fitted from Baseline up to Week 52 with factors for treatment, time, dialysis type, region, Baseline value and Baseline value by time and treatment by time interactions.|||0.0331|-0.0326|0.4939
72396801|NCT02879305|144299426|SUPERIORITY||LS mean difference|-1.8||||0.9292|TWO_SIDED|95.0|-4.2|0.6|||MMRM||MMRM model was fitted from Baseline up to Week 52 with factors for treatment, time, dialysis type, region, Baseline value and Baseline value by time and treatment by time interactions.|||0.6|-4.2|0.9292
72396802|NCT02879305|144299427|SUPERIORITY||LS mean difference|-0.06||||0.0428|TWO_SIDED|95.0|-0.13|0.01|||MMRM||Week 8: Model was fitted from Baseline up to Week 52 and model adjusted Week 8 data has been presented, with factors for treatment, time, dialysis type, region, Baseline value and Baseline value by time and treatment by time interactions.|||0.01|-0.13|0.0428
72396803|NCT02879305|144299427|SUPERIORITY||LS mean difference|-0.04||||0.1155|TWO_SIDED|95.0|-0.11|0.03|||MMRM||Week 12: Model was fitted from Baseline up to Week 52 and model adjusted Week 12 data has been presented, with factors for treatment, time, dialysis type, region, Baseline value and Baseline value by time and treatment by time interactions.|||0.03|-0.11|0.1155
72396804|NCT02879305|144299427|SUPERIORITY||LS mean difference|-0.04||||0.1426|TWO_SIDED|95.0|-0.12|0.03|||MMRM||Week 28: Model was fitted from Baseline up to Week 52 and model adjusted Week 28 data has been presented, with factors for treatment, time, dialysis type, region, Baseline value and Baseline value by time and treatment by time interactions.|||0.03|-0.12|0.1426
72396805|NCT02879305|144299427|SUPERIORITY||LS mean difference|-0.05||||0.1152|TWO_SIDED|95.0|-0.13|0.03|||MMRM||Week 52: Model was fitted from Baseline up to Week 52 and model adjusted Week 52 data has been presented, with factors for treatment, time, dialysis type, region, Baseline value and Baseline value by time and treatment by time interactions.|||0.03|-0.13|0.1152
72396806|NCT02423577|144299443|SUPERIORITY||Risk Ratio (RR)|1.14||||0.1436|TWO_SIDED|90.0|0.98|1.31|||Chi-squared|||||1.31|0.98|0.1436
72396807|NCT02392247|144299447|SUPERIORITY_OR_OTHER||Slope|0.34|||<|0.001|TWO_SIDED|95.0|0.26|0.44||This study was not designed to determine which method is 'superior'.Statistical significance refers to deviation of slope for perfect agreement (=1) between paired measurements to quantify strength of association .|Deming Regression||Slope measured deviation from 1:1 concordance between SEER and TEG with TEG measurement as denominator. Confidence intervals were obtained by bootstrapping 1000 times on the parameters estimates for the slopes, intervals and correlation coefficients|A cohort of 50 patients was estimated to capture at least 7 'bleeding' patients with a likelihood of 95%, assuming a 25% incidence of bleeding, and standard deviation of 20%, to determine maximum clot stiffness within +/- 10% of the mean. This was a descriptive and method-comparison study. Method comparisons were performed according to Clinical Laboratory Science Institute (CLSI) guidelines (Deming regression on paired measurements)||0.44|0.26|<0.001
72471669|NCT00474526|144466762|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA3 over LA4, the lower limit of the two-sided 95% CI for the difference in seroresponse rates (PLA3 - PLA4) must be greater than 5% for poliovirus and greater than -10% for all other antigens.|Seroconversion Percentage difference|1.0||||||95.0|-3.7|7.0|||ANOVA|||PnC 23F (Seroconversion percentage difference (PLA3 - PLA4))||7|-3.7|
72471670|NCT00474526|144466777|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of US1A over US1B, the lower limit of 95% CI for the ratio of pneumococcal GMCs (GMCUS1A / GMCUS1B) had to be greater than 0.50.|Ratio of GMCs|0.9|||||TWO_SIDED|95.0|0.67|1.2|||ANOVA|||PnC 4 (Post-vaccination GMC; group ratio US1A:US1B)||1.2|0.67|
72396808|NCT02392247|144299448|SUPERIORITY_OR_OTHER||Slope|3.1|||<|0.001|TWO_SIDED|95.0|2.9|3.4||This study was not designed to determine which method is 'superior'. Statistical significance refers to deviation of slope for perfect agreement (=1) between paired measurements to quantify strength of association .|Deming regression|Confidence intervals were obtained by bootstrapping 1000 times on the parameters estimates for the slopes, intervals and correlation coefficients|Slope measured deviation from 1:1 concordance between SEER and TEG with TEG as denominator. Confidence intervals were obtained by bootstrapping 1000 times on the parameters estimates for the slopes, intervals and correlation coefficients|A cohort of 50 patients was estimated to capture at least 7 'bleeding' patients with a likelihood of 95%, assuming a 25% incidence of bleeding, and standard deviation of 20%, to determine maximum clot stiffness within +/- 10% of the mean. This was a descriptive and method-comparison study. Method comparisons were performed according to Clinical Laboratory Science Institute (CLSI) guidelines (Deming regression on paired measurements )||3.4|2.9|<0.001
72396809|NCT03010254|144299449|SUPERIORITY||Least Squares Mean Difference|-0.138|STANDARD_ERROR_OF_MEAN|0.021|<|0.001|TWO_SIDED|95.0|-0.18|-0.097||2-sided p-value reported. A hypothesis test was based on a two sample t-test, with a type I error rate of 0.025, 1-sided.|t-test, 2 sided||Least squares mean difference (DFT015 - SN60WF)|||-0.097|-0.180|<0.001
72396810|NCT03010254|144299451|NON_INFERIORITY|Non-inferiority margin was 0.1 logMAR.|Least Squares Mean Difference|0.037|STANDARD_ERROR_OF_MEAN|0.0115|||ONE_SIDED|97.5||0.059|||||Least squares mean difference (DFT015 - SN60WF).The 1-sided 97.5% Upper Confidence Limit is presented.|||0.059||
72396811|NCT03010254|144299452|SUPERIORITY||Least Squares Mean Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.0216|<|0.001|TWO_SIDED|95.0|-0.133|-0.048||2-sided p-value reported. A hypothesis test was based on a two sample t-test, with a type I error rate of 0.025, 1-sided.|t-test, 2 sided||Least squares mean difference (DFT015 - SN60WF)|||-0.048|-0.133|<0.001
72396812|NCT03010254|144299453|OTHER||Mean difference in depth of focus|0.52|||||TWO_SIDED|||||Hypothesis testing was not pre-specified.|||Mean difference in depth of focus (DFT015 - SN60WF)|||||
72396813|NCT03010254|144299454|NON_INFERIORITY|Non-inferiority margin was -0.15 log unit|Least Squares Mean Difference|-0.179|STANDARD_ERROR_OF_MEAN|0.0551|||ONE_SIDED|97.5|-0.287||||||Least squares mean difference (DFT015 - SN60WF). The 1-sided 97.5 Lower Limit Confidence Interval is presented.|Without glare|||-0.287|
72396814|NCT03010254|144299454|NON_INFERIORITY|Non-inferiority margin was -0.15 log unit|Least Squares Mean Difference|-0.181|STANDARD_ERROR_OF_MEAN|0.0541|||ONE_SIDED|97.5|-0.287||||||Least squares mean difference (DFT015 - SN60WF). The 1-sided 97.5 Lower Limit Confidence Interval is presented.|With glare|||-0.287|
72396815|NCT03010254|144299455|SUPERIORITY||Difference in percentage|20.2|||||TWO_SIDED|95.0|8.77|31.04|||||95% CI for the difference (DFT015 - SN60WF) is estimated using Miettinen-Nurminen method (1985).|||31.04|8.77|
72396816|NCT03010254|144299456|SUPERIORITY||Percent difference|21.7|||||TWO_SIDED|95.0|7.92|35.06|||||95% CI for the difference (DFT015 - SN60WF) is estimated using Miettinen-Nurminen method (1985).|||35.06|7.92|
72396817|NCT02144233|144299459|SUPERIORITY|||||||0.54|||||||Mixed Models Analysis|||||||0.54
72396818|NCT02068443|144299494|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.65|STANDARD_ERROR_OF_MEAN|0.087|||TWO_SIDED|95.0|-0.821|-0.48|||||Estimated Value was for the difference between Alogliptin + Metformin Hydrochloride QD and Alogliptin alone (Metformin QD - Alogliptin alone).|||-0.480|-0.821|
72396819|NCT02068443|144299494|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority of Alogliptin + Metformin Hydrochloride QD to Alogliptin + Metformin Hydrochloride BID.|LS Mean Difference|0.11|STANDARD_ERROR_OF_MEAN|0.069|||TWO_SIDED|95.0|-0.026|0.247|||||Estimated Value was for the difference between Alogliptin + Metformin Hydrochloride QD and Alogliptin + Metformin Hydrochloride BID (Metformin QD - Metformin BID).|||0.247|-0.026|
72396820|NCT01986855|144299504|SUPERIORITY_OR_OTHER||Difference in the least squares means|-0.03||||0.807|TWO_SIDED|95.0|-0.23|0.18||The cLDA model included fixed effects for treatment, time, eGFR stratum (\<45 or ≥45 mL/min/1.73m\^2), baseline treatment with insulin stratum (yes/no), and the interaction of time by treatment. Time was treated as a categorical variable.|Constrained longitudinal data analysis|||||0.18|-0.23|0.807
72396821|NCT01986855|144299504|SUPERIORITY_OR_OTHER||Difference in the least squares means|-0.15||||0.155|TWO_SIDED|95.0|-0.35|0.06||The cLDA model included fixed effects for treatment, time, eGFR stratum (\<45 or ≥45 mL/min/1.73m\^2), baseline treatment with insulin stratum (yes/no), and the interaction of time by treatment. Time was treated as a categorical variable.|Constrained longitudinal data analysis|||||0.06|-0.35|0.155
72396822|NCT01986855|144299505|SUPERIORITY_OR_OTHER||Difference in Percentages vs. Placebo|3.6|||||TWO_SIDED|95.0|-4.8|12.1|||||Miettinen \& Nurminen Method|||12.1|-4.8|
72396823|NCT01986855|144299505|SUPERIORITY_OR_OTHER||Difference in Percentages vs. Placebo|-7.0|||||TWO_SIDED|95.0|-16.3|2.3|||||Miettinen \& Nurminen Method|||2.3|-16.3|
72396824|NCT01986855|144299506|SUPERIORITY_OR_OTHER||Difference in Percentages vs. Placebo|3.0|||||TWO_SIDED|95.0|-2.7|9.0|||||Miettinen \& Nurminen Method|||9.0|-2.7|
72396825|NCT01986855|144299506|SUPERIORITY_OR_OTHER||Difference in Percentages vs. Placebo|-1.3|||||TWO_SIDED|95.0|-6.5|3.7|||||Miettinen \& Nurminen Method|||3.7|-6.5|
72396826|NCT01986855|144299507|SUPERIORITY_OR_OTHER||Difference in the least squares means|-0.03||||0.828|TWO_SIDED|95.0|-0.28|0.23||The cLDA model included fixed effects for treatment, time, baseline treatment with insulin stratum (yes/no), and the interaction of time by treatment. Time was treated as a categorical variable.|Constrained longitudinal data analysis|||||0.23|-0.28|0.828
72396827|NCT01986855|144299507|SUPERIORITY_OR_OTHER||Difference in the least squares means|-0.09||||0.496|TWO_SIDED|95.0|-0.35|0.17||The cLDA model included fixed effects for treatment, time, baseline treatment with insulin stratum (yes/no), and the interaction of time by treatment. Time was treated as a categorical variable.|Constrained longitudinal data analysis|||||0.17|-0.35|0.496
72506037|NCT01422304|144543658|SUPERIORITY_OR_OTHER_LEGACY||Geometric Mean Ratio (GMR) (%)|5.5|||||TWO_SIDED|95.0|3.7|7.3|||Constrained Longitudinal Data Analysis|Model included those in APaT population with any baseline or post baseline aPTT value in 10 or 60 minute window (Sugammadex, Usual Care N=567, 548)|Estimate of difference in Sugammadex versus Usual Care change from baseline at 10 minutes post dose calculated with log of aPTT values as dependent variable. Results transformed back to GMR of respective changes (expressed as %, = \[GMR - 1\]\*100).|Model was restricted to have no difference between treatment groups for baseline assessment, and was adjusted for center, usual care group (active reversal or spontaneous recovery), renal function (estimated creatinine clearance \< or ≥ 60 mL/min), prophylactic antithrombotic therapy (including LMWH, including UFH, or not including either LMWH or UFH), type of hip/knee surgical procedure, and the interaction of time by treatment.||7.3|3.7|
72396828|NCT01986855|144299508|SUPERIORITY_OR_OTHER||Difference in the least squares means|-1.77|||<|0.001|TWO_SIDED|95.0|-2.57|-0.96||The cLDA model included fixed effects for treatment, time, baseline treatment with insulin stratum (yes/no), and the interaction of time by treatment. Time was treated as a categorical variable. P-value is nominal.|Constrained longitudinal data analysis|||||-0.96|-2.57|<0.001
72396829|NCT01986855|144299508|SUPERIORITY_OR_OTHER||Difference in the least squares means|-1.84|||<|0.001|TWO_SIDED|95.0|-2.66|-1.02||The cLDA model included fixed effects for treatment, time, baseline treatment with insulin stratum (yes/no), and the interaction of time by treatment. Time was treated as a categorical variable. P-value is nominal.|Constrained longitudinal data analysis|||||-1.02|-2.66|<0.001
72506038|NCT01422304|144543658|SUPERIORITY_OR_OTHER_LEGACY||GMR (%)|0.9||||||95.0|-0.9|2.8|||Constrained Longitudinal Data Analysis|Model included those in APaT population with any baseline or post baseline aPTT value in 10 or 60 minute window (Sugammadex, Usual Care N=567, 548)|Estimate of difference in Sugammadex versus Usual Care change from baseline at 60 minutes post dose calculated with log of aPTT values as dependent variable. Results transformed back to GMR of respective changes (expressed as %, = \[GMR - 1\]\*100).|Model was restricted to have no difference between treatment groups for baseline assessment, and was adjusted for center, usual care group (active reversal or spontaneous recovery), renal function (estimated creatinine clearance \< or ≥ 60 mL/min), prophylactic antithrombotic therapy (including LMWH, including UFH, or not including either LMWH or UFH), type of hip/knee surgical procedure, and the interaction of time by treatment.||2.8|-0.9|
72506039|NCT01422304|144543659|SUPERIORITY_OR_OTHER_LEGACY||GMR (%)|3.0|||||TWO_SIDED|95.0|1.3|4.7|||Constrained Longitudinal Data Analysis|Model included those in APaT population with any baseline or post baseline PT(INR) value in 10 or 60 minute window (Sugammadex, Usual Care N=567, 548)|Estimate of difference in Sugammadex versus Usual Care change from baseline at 10 minutes post dose calculated with log of PT(INR) values as dependent variable. Results transformed back to GMR of respective changes (expressed as %, = \[GMR - 1\]\*100).|Model was restricted to have no difference between treatment groups for baseline assessment, and was adjusted for center, usual care group (active reversal or spontaneous recovery), renal function (estimated creatinine clearance \< or ≥ 60 mL/min), prophylactic antithrombotic therapy (including LMWH, including UFH, or not including either LMWH or UFH), type of hip/knee surgical procedure, and the interaction of time by treatment.||4.7|1.3|
72506040|NCT01422304|144543659|SUPERIORITY_OR_OTHER_LEGACY||GMR (%)|0.9|||||TWO_SIDED|95.0|-1.0|2.9|||Constrained Longitudinal Data Analysis|Model included those in APaT population with any baseline or post baseline PT(INR) value in 10 or 60 minute window (Sugammadex, Usual Care N=567, 548)|Estimate of difference in Sugammadex versus Usual Care change from baseline at 60 minutes post dose calculated with log of PT(INR) values as dependent variable. Results transformed back to GMR of respective changes (expressed as %, = \[GMR - 1\]\*100).|Model was restricted to have no difference between treatment groups for baseline assessment, and was adjusted for center, usual care group (active reversal or spontaneous recovery), renal function (estimated creatinine clearance \< or ≥ 60 mL/min), prophylactic antithrombotic therapy (including LMWH, including UFH, or not including either LMWH or UFH), type of hip/knee surgical procedure, and the interaction of time by treatment.||2.9|-1.0|
72506041|NCT01422304|144543660|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (%)|-0.6|||||TWO_SIDED|95.0|-3.0|1.8|||Miettinen and Nurminen||Risk difference (%) = Sugammadex incidence - Usual Care incidence|||1.8|-3.0|
72506042|NCT01422304|144543661|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (%)|-1.4|||||TWO_SIDED|95.0|-3.4|0.5|||Miettinen and Nurminen||Risk difference (%) = Sugammadex incidence - Usual Care incidence|||0.5|-3.4|
72506043|NCT01422304|144543662|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (%)|-0.9|||||TWO_SIDED|95.0|-3.1|1.2|||Miettinen and Nurminen||Risk difference (%) = Sugammadex incidence - Usual Care incidence|||1.2|-3.1|
72506044|NCT01422304|144543663|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (%)|0.3|||||TWO_SIDED|95.0|-0.7|1.5|||Miettinen and Nurminen||Risk difference (%) = Sugammadex incidence - Usual Care incidence|||1.5|-0.7|
72506045|NCT01422304|144543665|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-7.2|||||TWO_SIDED|95.0|-45.0|30.5|||Generalized Linear Model||Difference is Sugammadex versus Usual Care. A negative value indicates that the average adjusted drainage volume was lower in the sugammadex treatment group.|Generalized Linear Model was adjusted for strata (renal function and use of prophylactic antithrombotic therapy) and investigational site.||30.5|-45.0|
72506046|NCT01422304|144543666|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (%)|-2.7|||||TWO_SIDED|95.0|-7.4|2.0|||Miettinen and Nurminen||Risk difference (%) = Sugammadex incidence - Usual Care incidence, adjusted for strata and investigational site|Miettinen and Nurminen Method was adjusted for strata (renal function and use of prophylactic antithrombotic therapy) and investigational site||2.0|-7.4|
72506047|NCT01422304|144543667|SUPERIORITY_OR_OTHER_LEGACY||GMR|1.1|||||TWO_SIDED|95.0|0.98|1.24|||Generalized Linear Model||GMR is Sugammadex versus Usual Care|Generalized Linear Model was applied to transfusion volume transformed to the log-scale, adjusted for strata (renal function and use of prophylactic antithrombotic therapy) and investigational site. Result and 95% Confidence Interval was transformed back to the original scale.||1.24|0.98|
72506048|NCT01422304|144543668|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.4|||||TWO_SIDED|95.0|-0.4|3.1|||Generalized Linear Model||Difference is Sugammadex versus Usual Care. A positive value indicates that the average adjusted reduction in Hgb at Visit 3 (bleeding index) was lower in the sugammadex treatment group.|Generalized Linear Model was adjusted for strata (renal function and use of prophylactic antithrombotic therapy), investigational site and baseline hemoglobin value.||3.1|-0.4|
72506049|NCT01422304|144543669|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (%)|-1.6|||||TWO_SIDED|95.0|-6.3|3.1|||Miettinen and Nurminen||Risk difference (%) = Sugammadex incidence - Usual Care incidence|||3.1|-6.3|
72396830|NCT01986855|144299509|SUPERIORITY_OR_OTHER||Difference in the least squares means|-1.42||||0.451|TWO_SIDED|95.0|-5.13|2.29||The cLDA model included fixed effects for treatment, time, baseline treatment with insulin stratum (yes/no), and the interaction of time by treatment. Time was treated as a categorical variable.|Constrained longitudinal data analysis|||||2.29|-5.13|0.451
72396831|NCT01986855|144299509|SUPERIORITY_OR_OTHER||Difference in the least squares means|-3.46||||0.072|TWO_SIDED|95.0|-7.24|0.31||The cLDA model included fixed effects for treatment, time, baseline treatment with insulin stratum (yes/no), and the interaction of time by treatment. Time was treated as a categorical variable.|Constrained longitudinal data analysis|||||0.31|-7.24|0.072
72396832|NCT01986855|144299510|SUPERIORITY_OR_OTHER||Difference in the least squares means|-6.81||||0.291|TWO_SIDED|96.0|-19.47|5.85||The cLDA model included fixed effects for treatment, time, baseline treatment with insulin stratum (yes/no), and the interaction of time by treatment. Time was treated as a categorical variable.|Constrained longitudinal data analysis|||||5.85|-19.47|0.291
72396833|NCT01986855|144299510|SUPERIORITY_OR_OTHER||Difference in the least squares means|-15.51||||0.019|TWO_SIDED|95.0|-28.5|-2.53||The cLDA model included fixed effects for treatment, time, baseline treatment with insulin stratum (yes/no), and the interaction of time by treatment. Time was treated as a categorical variable. P-value is nominal.|Constrained longitudinal data analysis|||||-2.53|-28.50|0.019
72396834|NCT01986855|144299511|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.16||||0.713|TWO_SIDED|95.0|0.53|2.56||Adjusted Odds Ratio based on a logistic regression model fitted with fixed effects for treatment, baseline treatment with insulin stratum (yes/no), and a covariate for baseline A1C.|Logistic regression model|||||2.56|0.53|0.713
72396835|NCT01986855|144299511|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.06||||0.89|TWO_SIDED|95.0|0.44|2.55||Adjusted Odds Ratio based on a logistic regression model fitted with fixed effects for treatment, baseline treatment with insulin stratum (yes/no), and a covariate for baseline A1C.|Logistic regression model|||||2.55|0.44|0.890
72396836|NCT00710710|144299528|OTHER||Maximum likelihood estimation|0.0233||||0.7021|TWO_SIDED|95.0|0.0006|0.1229||p0 = 0.056, one sided exact binomial test with a 2.5% significance level|Exact binomial test|||Confirmed objective response, comparison with historical controls (Gemcitabine)||0.1229|0.0006|0.7021
72396837|NCT00710710|144299528|OTHER||Maximum likelihood estimation|0.0233||||0.9156|TWO_SIDED|95.0|0.0006|0.1229||p0 = 0.092, one sided exact binomial test with a 2.5% significance level|Exact binomial test|||Confirmed objective response, comparison with historical controls (Gemcitabine)||0.1229|0.0006|0.9156
72396838|NCT00710710|144299528|OTHER||Maximum likelihood estimation|0.0233||||0.7021|TWO_SIDED|95.0|0.0006|0.1229||p0 = 0.056, one sided exact binomial test with a 2.5% significance level|Exact binomial test|||Confirmed objective response, comparison with historical controls (Gemcitabine)||0.1229|0.0006|0.7021
72396839|NCT00710710|144299528|OTHER||Maximum likelihood estimation|0.0233||||0.9156|TWO_SIDED|95.0|0.0006|0.1229||p0 = 0.092, one sided exact binomial test with a 2.5% significance level|Exact binomial test|||Confirmed objective response, comparison with historical controls (Gemcitabine)||0.1229|0.0006|0.9156
72396840|NCT00710710|144299531|OTHER||Hazard Ratio (HR)|1.22||||0.38|TWO_SIDED|95.0|0.78|1.91|||Regression, Cox||if HR is below 1, then 60mg BI 2536 IV on day 1-3 is better.|||1.91|0.78|0.38
72471671|NCT00474526|144466777|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of US1A over US1B, the lower limit of 95% CI for the ratio of pneumococcal GMCs (GMCUS1A / GMCUS1B) had to be greater than 0.50.|Ratio of GMCs|0.8|||||TWO_SIDED|95.0|0.62|1.02|||ANOVA|||PnC 6B (Post-vaccination GMC; group ratio US1A:US1B)||1.02|0.62|
72471672|NCT00474526|144466777|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of US1A over US1B, the lower limit of 95% CI for the ratio of pneumococcal GMCs (GMCUS1A / GMCUS1B) had to be greater than 0.50.|Ratio of GMCs|0.89|||||TWO_SIDED|95.0|0.67|1.2|||ANOVA|||PnC 9V (Post-vaccination GMC; group ratio US1A:US1B)||1.2|0.67|
72396841|NCT00710710|144299532|OTHER||Hazard Ratio (HR)|1.1||||0.69|TWO_SIDED|95.0|0.68|1.78|||Regression, Cox||if HR is below 1, then 60mg BI 2536 IV on day 1-3 is better.|||1.78|0.68|0.69
72396842|NCT00710710|144299533|OTHER||Maximum likelihood estimation|0.0||||0.9161|TWO_SIDED|95.0|0.0|0.0822||p0 = 0.056, one sided exact binomial test with a 2.5% significance level|Exact binomial test|||Confirmed objective response, comparison with historical controls (Gemcitabine)||0.0822|0.0000|0.9161
72396843|NCT00710710|144299533|OTHER||Maximum likelihood estimation|0.0||||0.9842|TWO_SIDED|95.0|0.0|0.0822||p0 = 0.092, one sided exact binomial test with a 2.5% significance level|Exact binomial test|||Confirmed objective response, comparison with historical controls (Gemcitabine)||0.0822|0.0000|0.9842
72396844|NCT00710710|144299533|OTHER||Maximum likelihood estimation|0.0||||0.9161|TWO_SIDED|95.0|0.0|0.0822||p0 = 0.056, one sided exact binomial test with a 2.5% significance level|Exact binomial test|||Confirmed objective response, comparison with historical controls (Gemcitabine)||0.0822|0.0000|0.9161
72396845|NCT00710710|144299533|OTHER||Maximum likelihood estimation|0.0||||0.9842|TWO_SIDED|95.0|0.0|0.0822||p0 = 0.092, one sided exact binomial test with a 2.5% significance level|Exact binomial test|||Confirmed objective response, comparison with historical controls (Gemcitabine)||0.0822|0.0000|0.9842
72506050|NCT00945750|144543709|NON_INFERIORITY_OR_EQUIVALENCE|If the 90% CI for the AUC geometric mean ratio (famotidine CT without water/famotidine FCT with water) is within the hypothesized interval (0.80 and 1.25), then the primary hypothesis of bioequivalence between CT without water and FCT with water is accepted.|Geometric Mean Ratio|1.01||||||90.0|0.94|1.09||||||||1.09|0.94|
72396846|NCT00715078|144299540|NON_INFERIORITY_OR_EQUIVALENCE|Cohort B is considered non-inferior to Cohort A if the lower limit of the 90% confidence interval (CI) for the ratio of Cohort B vs. Cohort A in the geometric mean of cumulative CD54 upregulation ratio is \>0.8. The use of one-sided CI is based on an assumption that a higher concentration will correspond to a higher CD54 upregulation ratio. The use of 0.8 as margin is based on the assumption that a relative difference of \<20% in upregulation ratios may not be clinically significant.|ratio of geometric means (GeoMean)|1.046||||0.5019|TWO_SIDED|90.0|0.936|1.168|||ANOVA|||The sample size determination is based on a standard deviation of 0.45 for the log transformed CD54 upregulation ratio estimated from previous studies assuming there is no difference in central values between the two compared cohorts. A sample size of 38 subjects per cohort will provide 70% power for the non-inferiority test for the two pairwise comparisons (Cohort B vs. Cohort A and Cohort C vs. Cohort A).||1.168|0.936|0.5019
72471673|NCT00474526|144466777|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of US1A over US1B, the lower limit of 95% CI for the ratio of pneumococcal GMCs (GMCUS1A / GMCUS1B) had to be greater than 0.50.|Ratio of GMCs|0.8|||||TWO_SIDED|95.0|0.63|1.03|||ANOVA|||PnC 14 (Post-vaccination GMC; group ratio US1A:US1B)||1.03|0.63|
72471674|NCT00474526|144466777|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of US1A over US1B, the lower limit of 95% CI for the ratio of pneumococcal GMCs (GMCUS1A / GMCUS1B) had to be greater than 0.50.|Ratio of GMCs|1.02|||||TWO_SIDED|95.0|0.78|1.34|||ANOVA|||PnC 18C (Post-vaccination GMC; group ratio US1A:US1B)||1.34|0.78|
72471675|NCT00474526|144466777|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of US1A over US1B, the lower limit of 95% CI for the ratio of pneumococcal GMCs (GMCUS1A / GMCUS1B) had to be greater than 0.50.|Ratio of GMCs|1.04||||||95.0|0.81|1.34|||ANOVA|||PnC 19F (Post-vaccination GMC; group ratio US1A:US1B)||1.34|0.81|
72396847|NCT00715078|144299540|NON_INFERIORITY_OR_EQUIVALENCE|Cohort C is considered non-inferior to Cohort A if the lower limit of the 90% confidence interval for the ratio of Cohort C vs. Cohort A in the geometric mean of cumulative CD54 upregulation ratio is \>0.8. The use of one-sided CI is based on an assumption that a higher concentration will correspond to a higher CD54 upregulation ratio. The use of 0.8 as margin is based on the assumption that a relative difference of \<20% in upregulation ratios may not be clinically significant.|the ratio of geometric means|0.907||||0.1443|TWO_SIDED|90.0|0.813|1.013|||ANOVA|||The sample size determination is based on a standard deviation of 0.45 for the log transformed CD54 upregulation ratio estimated from previous studies assuming there is no difference in central values between the two compared cohorts. A sample size of 38 subjects per cohort will provide 70% power for the non-inferiority test for the two pairwise comparisons (Cohort B vs. Cohort A and Cohort C vs. Cohort A).||1.013|0.813|0.1443
72396848|NCT00157950|144299541|SUPERIORITY_OR_OTHER||Proportion|98.2|||||TWO_SIDED|95.0|93.6|99.8|||||Exact binomial confidence interval|||99.8|93.6|
72396849|NCT00157950|144299542|NON_INFERIORITY_OR_EQUIVALENCE|The lower bound of the 95% confidence interval for the proportion of subjects receiving Gardasil who were seropositive at Week 4 postdose 3 must be greater than 90%|Proportion|100.0|||||TWO_SIDED|95.0|96.8|100.0|||||Exact binomial confidence interval|||100|96.8|
72396850|NCT00157950|144299543|NON_INFERIORITY_OR_EQUIVALENCE|The lower bound of the 95% confidence interval for the proportion of subjects receiving Gardasil who were seropositive at Week 4 postdose 3 must be greater than 90%|Proportion|99.1|||||TWO_SIDED|95.0|95.2|100.0|||||Exact binomial confidence interval|||100|95.2|
72396851|NCT00157950|144299544|NON_INFERIORITY_OR_EQUIVALENCE|The lower bound of the 95% confidence interval for the proportion of subjects receiving Gardasil who were seropositive at Week 4 postdose 3 must be greater than 90%|Proportion|99.1|||||TWO_SIDED|95.0|95.0|100.0|||||Exact binomial confidence interval|||100|95.0|
72396852|NCT01500629|144299594|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.79||||0.156|TWO_SIDED|95.0|-1.9|0.33|||Mixed Models Analysis|Treatment, period and sequence as fixed effects and subject as a random effect.||The following comparison was made: Allergen Block (C-1266-7) vs placebo. For this comparison, the following hypothesis was tested: Ho: µ1= µ2 against the two-sided alternative H1: µ1≠ µ2 where µ1 and µ2 are the mean values of the parameter variable for the two treatment groups.||0.33|-1.90|0.156
72396853|NCT01500629|144299595|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.28||||0.625|TWO_SIDED|95.0|-1.49|0.92|||Mixed Models Analysis|Treatment, period and sequence as fixed effects and subject as a random effect.||The following comparison was made: Allergen Block (C-1266-7) vs placebo. For this comparison, the following hypothesis was tested: Ho: µ1= µ2 against the two-sided alternative H1: µ1≠ µ2 where µ1 and µ2 are the mean values of the parameter variable for the two treatment groups.||0.92|-1.49|0.625
72396854|NCT01500629|144299596|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.72||||0.291|TWO_SIDED|95.0|-2.12|0.67|||Mixed Models Analysis|Treatment, period and sequence as fixed effects and subject as a random effect.||The following comparison was made: Allergen Block (C-1266-7) vs placebo. For this comparison, the following hypothesis was tested: Ho: µ1= µ2 against the two-sided alternative H1: µ1≠ µ2 where µ1 and µ2 are the mean values of the parameter variable for the two treatment groups.||0.67|-2.12|0.291
72396855|NCT01500629|144299597|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.07||||0.899|TWO_SIDED|95.0|-1.21|1.07|||Mixed Models Analysis|Treatment, period and sequence as fixed effects and subject as a random effect.||The following comparison was made: Allergen Block (C-1266-7) vs placebo. For this comparison, the following hypothesis was tested: Ho: µ1= µ2 against the two-sided alternative H1: µ1≠ µ2 where µ1 and µ2 are the mean values of the parameter variable for the two treatment groups.||1.07|-1.21|0.899
72396856|NCT01500629|144299598|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.701||||||The rank sum test was based on period difference for comparison between sequence.|Wilcoxon (Mann-Whitney)|||The following comparison was made: Allergen Block (C-1266-7) vs placebo. For this comparison, the following hypothesis was tested: Ho: µ1= µ2 against the two-sided alternative H1: µ1≠ µ2 where µ1 and µ2 are the mean values of the parameter variable for the two treatment groups.||||0.701
72396857|NCT01500629|144299599|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.108||||||The rank sum test was based on period difference for comparison between sequence.|Wilcoxon (Mann-Whitney)|||The following comparison was made: Allergen Block (C-1266-7) vs placebo. For this comparison, the following hypothesis was tested: Ho: µ1= µ2 against the two-sided alternative H1: µ1≠ µ2 where µ1 and µ2 are the mean values of the parameter variable for the two treatment groups.||||0.108
72396858|NCT01500629|144299600|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-1.0||||0.253||||||The rank sum test was based on period difference for comparison between sequence.|Wilcoxon (Mann-Whitney)|||The following comparison was made: Allergen Block (C-1266-7) vs placebo. For this comparison, the following hypothesis was tested: Ho: µ1= µ2 against the two-sided alternative H1: µ1≠ µ2 where µ1 and µ2 are the mean values of the parameter variable for the two treatment groups.||||0.253
72396859|NCT01500629|144299601|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.287||||||The rank sum test was based on period difference for comparison between sequence.|Wilcoxon (Mann-Whitney)|||The following comparison was made: Allergen Block (C-1266-7) vs placebo. For this comparison, the following hypothesis was tested: Ho: µ1= µ2 against the two-sided alternative H1: µ1≠ µ2 where µ1 and µ2 are the mean values of the parameter variable for the two treatment groups.||||0.287
72471676|NCT00474526|144466777|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of US1A over US1B, the lower limit of 95% CI for the ratio of pneumococcal GMCs (GMCUS1A / GMCUS1B) had to be greater than 0.50.|Ratio of GMCs|0.94|||||TWO_SIDED|95.0|0.69|1.29|||ANOVA|||PnC 23F (Post-vaccination GMC; group ratio US1A:US1B)||1.29|0.69|
72506051|NCT00945750|144543710|NON_INFERIORITY_OR_EQUIVALENCE|If the 90% CI for the Cmax geometric mean ratio (famotidine CT without water/famotidine FCT with water) is within the hypothesized interval (0.80 and 1.25), then the primary hypothesis of bioequivalence between CT without water and FCT with water is accepted.|Geometric Mean Ratio|1.03||||||90.0|0.93|1.14||||||||1.14|0.93|
72506052|NCT00945750|144543711|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.11||||||90.0|1.04|1.2||||||||1.20|1.04|
72471677|NCT00474526|144466778|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of US1A over US1B, the lower limit of 95% CI for the difference in rates (PUS1A - PUS1B) had to be greater than -10%.|Percentage difference|1.0|||||TWO_SIDED|95.0|-8.0|10.0|||ANOVA|||PnC 4 (percentage difference (US1A - US1B))||10|-8|
72506053|NCT00945750|144543712|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.12||||||90.0|1.02|1.24||||||||1.24|1.02|
72396860|NCT01500629|144299602|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.409||||||The rank sum test was based on period difference for comparison between sequence.|Wilcoxon (Mann-Whitney)|||The following comparison was made: Allergen Block (C-1266-7) vs placebo. For this comparison, the following hypothesis was tested: Ho: µ1= µ2 against the two-sided alternative H1: µ1≠ µ2 where µ1 and µ2 are the mean values of the parameter variable for the two treatment groups.||||0.409
72396861|NCT01500629|144299603|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.092||||||The rank sum test was based on period difference for comparison between sequence.|Wilcoxon (Mann-Whitney)|||The following comparison was made: Allergen Block (C-1266-7) vs placebo. For this comparison, the following hypothesis was tested: Ho: µ1= µ2 against the two-sided alternative H1: µ1≠ µ2 where µ1 and µ2 are the mean values of the parameter variable for the two treatment groups.||||0.092
72396862|NCT01500629|144299604|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-1.0||||0.042||||||The rank sum test was based on period difference for comparison between sequence.|Wilcoxon (Mann-Whitney)|||The following comparison was made: Allergen Block (C-1266-7) vs placebo. For this comparison, the following hypothesis was tested: Ho: µ1= µ2 against the two-sided alternative H1: µ1≠ µ2 where µ1 and µ2 are the mean values of the parameter variable for the two treatment groups.||||0.042
72396863|NCT01500629|144299605|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.307||||||The rank sum test was based on period difference for comparison between sequence.|Wilcoxon (Mann-Whitney)|||The following comparison was made: Allergen Block (C-1266-7) vs placebo. For this comparison, the following hypothesis was tested: Ho: µ1= µ2 against the two-sided alternative H1: µ1≠ µ2 where µ1 and µ2 are the mean values of the parameter variable for the two treatment groups.||||0.307
72396864|NCT01500629|144299606|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.5||||0.903||||||The rank sum test was based on period difference for comparison between sequence.|Wilcoxon (Mann-Whitney)|||The following comparison was made: Allergen Block (C-1266-7) vs placebo. For this comparison, the following hypothesis was tested: Ho: µ1= µ2 against the two-sided alternative H1: µ1≠ µ2 where µ1 and µ2 are the mean values of the parameter variable for the two treatment groups.||||0.903
72396865|NCT01500629|144299607|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.121||||||The rank sum test was based on period difference for comparison between sequence.|Wilcoxon (Mann-Whitney)|||The following comparison was made: Allergen Block (C-1266-7) vs placebo. For this comparison, the following hypothesis was tested: Ho: µ1= µ2 against the two-sided alternative H1: µ1≠ µ2 where µ1 and µ2 are the mean values of the parameter variable for the two treatment groups.||||0.121
72396866|NCT01500629|144299608|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.3||||0.689||||||The rank sum test was based on period difference for comparison between sequence.|Wilcoxon (Mann-Whitney)|||The following comparison was made: Allergen Block (C-1266-7) vs placebo. For this comparison, the following hypothesis was tested: Ho: µ1= µ2 against the two-sided alternative H1: µ1≠ µ2 where µ1 and µ2 are the mean values of the parameter variable for the two treatment groups.||||0.689
72396867|NCT01500629|144299609|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.314||||||The rank sum test was based on period difference for comparison between sequence.|Wilcoxon (Mann-Whitney)|||The following comparison was made: Allergen Block (C-1266-7) vs placebo. For this comparison, the following hypothesis was tested: Ho: µ1= µ2 against the two-sided alternative H1: µ1≠ µ2 where µ1 and µ2 are the mean values of the parameter variable for the two treatment groups.||||0.314
72396868|NCT01500629|144299610|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.8||||0.034||||||The rank sum test was based on period difference for comparison between sequence.|Wilcoxon (Mann-Whitney)|||The following comparison was made: Allergen Block (C-1266-7) vs placebo. For this comparison, the following hypothesis was tested: Ho: µ1= µ2 against the two-sided alternative H1: µ1≠ µ2 where µ1 and µ2 are the mean values of the parameter variable for the two treatment groups.||||0.034
72506054|NCT02531035|144543713|SUPERIORITY||Percentage difference|13.4|||<|0.001|TWO_SIDED|95.0|8.97|17.81||P-values from Cochran-Mantel-Haenszel test stratified by different levels of stratification factors of BMI at Screening(\<25 kg/m\^2,\>=25 kg/m\^2),Week -2 A1C(\<=9.0%, \>9.0%),and using continuous subcutaneous insulin infusion(CSII) at Screening(yes,no).|Cochran-Mantel-Haenszel|||||17.81|8.97|< 0.001
72506055|NCT02531035|144543714|SUPERIORITY||Least Squares Mean Difference|-0.46|||<|0.001|TWO_SIDED|95.0|-0.54|-0.38|||MMRM|||Testing according to hierarchical procedure. Post-Baseline LS means and p-values were obtained from MMRM model with treatment, randomization stratum of BMI at Screening (\<25 kg/m\^2, \>=25 kg/m\^2), randomization stratum of Week -2 A1C (\<=9.0%, \>9.0%), randomization stratum of use of CSII at Screening (yes, no), time (study week), and a treatment-by-time interaction as fixed categorical effects, and Baseline A1C-by-time interaction as a covariate.||-0.38|-0.54|< 0.001
72506056|NCT02531035|144543715|SUPERIORITY||Least squares mean difference|-2.98|||<|0.001|TWO_SIDED|95.0|-3.31|-2.66|||MMRM|||Testing according to hierarchical procedure. Post-Baseline LS means and p-values were obtained from MMRM model with treatment, randomization stratum of BMI at Screening (\<25 kg/m\^2, \>=25 kg/m\^2), randomization stratum of Week -2 A1C (\<=9%, \>9%), randomization stratum of Use of CSII at Screening (Yes, No), time (study week), and a treatment-by-time interaction as fixed categorical effects, and Baseline weight-by-time interaction as a covariate.||-2.66|-3.31|< 0.001
72565697|NCT02709486|144662693|SUPERIORITY||Odds Ratio (OR)|2.28|||<|0.0001|TWO_SIDED|95.0|1.53|3.4|||Regression, Logistic|||Week 4, \>=50%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.40|1.53|<.0001
72396869|NCT01500629|144299611|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.845||||||The rank sum test was based on period difference for comparison between sequence.|Wilcoxon (Mann-Whitney)|||The following comparison was made: Allergen Block (C-1266-7) vs placebo. For this comparison, the following hypothesis was tested: Ho: µ1= µ2 against the two-sided alternative H1: µ1≠ µ2 where µ1 and µ2 are the mean values of the parameter variable for the two treatment groups.||||0.845
72396870|NCT01500629|144299612|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.619||||||The rank sum test was based on period difference for comparison between sequence.|Wilcoxon (Mann-Whitney)|||The following comparison was made: Allergen Block (C-1266-7) vs placebo. For this comparison, the following hypothesis was tested: Ho: µ1= µ2 against the two-sided alternative H1: µ1≠ µ2 where µ1 and µ2 are the mean values of the parameter variable for the two treatment groups.||||0.619
72396871|NCT01500629|144299613|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.803||||||The rank sum test was based on period difference for comparison between sequence.|Wilcoxon (Mann-Whitney)|||The following comparison was made: Allergen Block (C-1266-7) vs placebo. For this comparison, the following hypothesis was tested: Ho: µ1= µ2 against the two-sided alternative H1: µ1≠ µ2 where µ1 and µ2 are the mean values of the parameter variable for the two treatment groups.||||0.803
72396872|NCT01500629|144299614|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.3||||0.175||||||The rank sum test was based on period difference for comparison between sequence.|Wilcoxon (Mann-Whitney)|||The following comparison was made: Allergen Block (C-1266-7) vs placebo. For this comparison, the following hypothesis was tested: Ho: µ1= µ2 against the two-sided alternative H1: µ1≠ µ2 where µ1 and µ2 are the mean values of the parameter variable for the two treatment groups.||||0.175
72396873|NCT01500629|144299615|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.5||||0.206|||||||Wilcoxon (Mann-Whitney)|The rank sum test was based on period difference for comparison between sequence.||The following comparison was made: Allergen Block (C-1266-7) vs placebo. For this comparison, the following hypothesis was tested: Ho: µ1= µ2 against the two-sided alternative H1: µ1≠ µ2 where µ1 and µ2 are the mean values of the parameter variable for the two treatment groups.||||0.206
72396874|NCT01500629|144299616|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.5||||0.072||||||The rank sum test was based on period difference for comparison between sequence.|Wilcoxon (Mann-Whitney)|||The following comparison was made: Allergen Block (C-1266-7) vs placebo. For this comparison, the following hypothesis was tested: Ho: µ1= µ2 against the two-sided alternative H1: µ1≠ µ2 where µ1 and µ2 are the mean values of the parameter variable for the two treatment groups.||||0.072
72396875|NCT01500629|144299617|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.5||||0.014||||||The rank sum test was based on period difference for comparison between sequence.|Wilcoxon (Mann-Whitney)|||The following comparison was made: Allergen Block (C-1266-7) vs placebo. For this comparison, the following hypothesis was tested: Ho: µ1= µ2 against the two-sided alternative H1: µ1≠ µ2 where µ1 and µ2 are the mean values of the parameter variable for the two treatment groups.||||.0140
72396876|NCT01500629|144299618|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01||||0.907|TWO_SIDED|95.0|-0.24|0.22|||Mixed Models Analysis|Treatment, period and sequence as fixed effects and subject as a random effect.||The following comparison was made: Allergen Block (C-1266-7) vs placebo. For this comparison, the following hypothesis was tested: Ho: µ1= µ2 against the two-sided alternative H1: µ1≠ µ2 where µ1 and µ2 are the mean values of the parameter variable for the two treatment groups.||0.22|-0.24|0.907
72396877|NCT01500629|144299619|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.05||||0.666|TWO_SIDED|95.0|-0.28|0.18|||Mixed Models Analysis|Treatment, period and sequence as fixed effects and subject as a random effect.||The following comparison was made: Allergen Block (C-1266-7) vs placebo. For this comparison, the following hypothesis was tested: Ho: µ1= µ2 against the two-sided alternative H1: µ1≠ µ2 where µ1 and µ2 are the mean values of the parameter variable for the two treatment groups.||0.18|-0.28|0.666
72396878|NCT01500629|144299620|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.972|TWO_SIDED|95.0|-0.29|0.28|||Mixed Models Analysis|Treatment, period and sequence as fixed effects and subject as a random effect.||The following comparison was made: Allergen Block (C-1266-7) vs placebo. For this comparison, the following hypothesis was tested: Ho: µ1= µ2 against the two-sided alternative H1: µ1≠ µ2 where µ1 and µ2 are the mean values of the parameter variable for the two treatment groups.||0.28|-0.29|0.972
72396879|NCT01500629|144299621|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.14||||0.521|TWO_SIDED|95.0|-0.31|0.59|||Mixed Models Analysis|Treatment, period and sequence as fixed effects and subject as a random effect.||The following comparison was made: Allergen Block (C-1266-7) vs placebo. For this comparison, the following hypothesis was tested: Ho: µ1= µ2 against the two-sided alternative H1: µ1≠ µ2 where µ1 and µ2 are the mean values of the parameter variable for the two treatment groups.||0.59|-0.31|0.521
72396880|NCT01500629|144299622|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.12||||0.376|TWO_SIDED|95.0|-0.15|0.39|||Mixed Models Analysis|Treatment, period and sequence as fixed effects and subject as a random effect.||The following comparison was made: Allergen Block (C-1266-7) vs placebo. For this comparison, the following hypothesis was tested: Ho: µ1= µ2 against the two-sided alternative H1: µ1≠ µ2 where µ1 and µ2 are the mean values of the parameter variable for the two treatment groups.||0.39|-0.15|0.376
72396881|NCT01500629|144299623|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||0.35|TWO_SIDED|95.0|-0.11|0.3|||Mixed Models Analysis|Treatment, period and sequence as fixed effects and subject as a random effect.||The following comparison was made: Allergen Block (C-1266-7) vs placebo. For this comparison, the following hypothesis was tested: Ho: µ1= µ2 against the two-sided alternative H1: µ1≠ µ2 where µ1 and µ2 are the mean values of the parameter variable for the two treatment groups.||0.30|-0.11|0.350
72506057|NCT02531035|144543716|SUPERIORITY||Least Squares Mean Difference|-3.5|||=|0.002|TWO_SIDED|95.0|-5.7|-1.3|||MMRM|||Testing according to the hierarchical procedure. Post-Baseline LS means and p-values were obtained from MMRM model with treatment, randomization stratum of BMI at Screening (\<25 kg/m2, \>=25 kg/m2), randomization stratum of Week -2 A1C (\<=9.0%, \>9.0%), randomization stratum of use of CSII at Screening (yes, no), time (study week), and a treatment-by- time interaction as fixed categorical effects, and Baseline SBP-by-time interaction as a covariate.||-1.3|-5.7|= 0.002
72396882|NCT01500629|144299624|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01||||0.947|TWO_SIDED|95.0|-0.36|0.34|||Mixed Models Analysis|Treatment, period and sequence as fixed effects and subject as a random effect.||The following comparison was made: Allergen Block (C-1266-7) vs placebo. For this comparison, the following hypothesis was tested: Ho: µ1= µ2 against the two-sided alternative H1: µ1≠ µ2 where µ1 and µ2 are the mean values of the parameter variable for the two treatment groups.||0.34|-0.36|0.947
72396883|NCT01500629|144299625|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.05||||0.651|TWO_SIDED|95.0|-0.3|0.19|||Mixed Models Analysis|Treatment, period and sequence as fixed effects and subject as a random effect.||The following comparison was made: Allergen Block (C-1266-7) vs placebo. For this comparison, the following hypothesis was tested: Ho: µ1= µ2 against the two-sided alternative H1: µ1≠ µ2 where µ1 and µ2 are the mean values of the parameter variable for the two treatment groups.||0.19|-0.30|0.651
72396884|NCT01500629|144299630|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.46||||0.261|TWO_SIDED|95.0|-1.3|0.38|||Mixed Models Analysis|Treatment, period and sequence as fixed effects and subject as a random effect.||The following comparison was made: Allergen Block (C-1266-7) vs placebo. For this comparison, the following hypothesis was tested: Ho: µ1= µ2 against the two-sided alternative H1: µ1≠ µ2 where µ1 and µ2 are the mean values of the parameter variable for the two treatment groups.||0.38|-1.30|0.261
72396885|NCT01500629|144299631|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.27||||0.481|TWO_SIDED|95.0|-0.51|1.04|||Mixed Models Analysis|Treatment, period and sequence as fixed effects and subject as a random effect.||The following comparison was made: Allergen Block (C-1266-7) vs placebo. For this comparison, the following hypothesis was tested: Ho: µ1= µ2 against the two-sided alternative H1: µ1≠ µ2 where µ1 and µ2 are the mean values of the parameter variable for the two treatment groups.||1.04|-0.51|0.481
72396886|NCT01500629|144299632|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.02||||0.961|TWO_SIDED|95.0|-0.85|0.89|||Mixed Models Analysis|Treatment, period and sequence as fixed effects and subject as a random effect.||The following comparison was made: Allergen Block (C-1266-7) vs placebo. For this comparison, the following hypothesis was tested: Ho: µ1= µ2 against the two-sided alternative H1: µ1≠ µ2 where µ1 and µ2 are the mean values of the parameter variable for the two treatment groups.||0.89|-0.85|0.961
72396887|NCT01500629|144299633|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.24||||0.546|TWO_SIDED|95.0|-0.57|1.04|||Mixed Models Analysis|Treatment, period and sequence as fixed effects and subject as a random effect.||The following comparison was made: Allergen Block (C-1266-7) vs placebo. For this comparison, the following hypothesis was tested: Ho: µ1= µ2 against the two-sided alternative H1: µ1≠ µ2 where µ1 and µ2 are the mean values of the parameter variable for the two treatment groups.||1.04|-0.57|0.546
72396888|NCT02902965|144299637|OTHER||median PFS|8.5|||||TWO_SIDED|95.0|6.2|10.8|||||Kaplan-Meier estimates for median PFS and its associated 95% confidence intervals using log-log transformed Greenwood variance estimate were calculated.|||10.8|6.2|
72396889|NCT02902965|144299638|OTHER||ORR in %|56.8|||||TWO_SIDED|95.0|44.7|68.2|||||Overall response = confirmed sCR + CR + VGPR + PR with corresponding 95% Exact binomial Cl|||68.2|44.7|
72396890|NCT02902965|144299639|OTHER||PFS rate|6.6|||||TWO_SIDED|95.0|1.6|16.9|||||Kaplan-Meier method used for PFS rate and its associated 95% confidence intervals using log-log transformed Greenwood variance estimate were calculated.|||16.9|1.6|
72396891|NCT02902965|144299642|OTHER||median TTP|10.6|||||TWO_SIDED|95.0|7.8|12.0|||||KM estimates for median TTP with associated 95% CI|||12|7.8|
72396892|NCT02259582|144299666|SUPERIORITY|Based on RECIST v1.1. Response outcomes from an assessment done anytime less than Day 35 were considered as not evaluable unless the response assessment was progress disease.|Hazard Ratio (HR)|0.04|||=|0.0401|TWO_SIDED|95.0|0.013|0.095|||Log Rank|||The Kaplan-Meier method was used to estimate both the survival curves and the median survival time. The 95% confidence interval (CI) for the median survival time was calculated. A p-value for treatment effect was generated using a stratified Cox proportional hazards model.||.095|.013|=0.0401
72396893|NCT01067456|144299673|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.57||||0.79|TWO_SIDED||||||t-test, 2 sided|||||||0.79
72396894|NCT00799487|144299683|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-27.3|||<|0.0001|TWO_SIDED|95.0|-34.4|-20.2||P-values were determined by using a repeated measures mixed model with actual value as the dependent variable with terms for treatment, time, treatment by time interaction, period, sequence, and baseline score.|Mixed Models Analysis||Placebo minus Concerta|||-20.2|-34.4|<0.0001
72396895|NCT00799487|144299684|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-28.0|||<|0.0001|TWO_SIDED|95.0|-35.1|-20.8||P-values were determined by using a repeated measures mixed model with actual value as the dependent variable with terms for treatment, time, treatment by time interaction, period, sequence, and baseline score.|Mixed Models Analysis||Placebo minus Concerta|||-20.8|-35.1|<0.0001
72471678|NCT00474526|144466778|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of US1A over US1B, the lower limit of 95% CI for the difference in rates (PUS1A - PUS1B) had to be greater than -10%.|Percentage difference|4.0|||||TWO_SIDED|95.0|0.0|10.0|||ANOVA|||PnC 6B (percentage difference (US1A - US1B))||10|0|
72396896|NCT00799487|144299685|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|5.0|||<|0.0001|TWO_SIDED|95.0|3.4|6.6||P-values were determined by using a repeated measures mixed model with actual value as the dependent variable with terms for treatment, time, treatment by time interaction, period, sequence, and baseline score.|Mixed Models Analysis||Placebo minus Concerta|||6.6|3.4|<0.0001
72396897|NCT00799487|144299686|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|4.5|||<|0.0001|TWO_SIDED|95.0|3.2|5.8||P-values were determined by using a repeated measures mixed model with actual value as the dependent variable with terms for treatment, time, treatment by time interaction, period, sequence, and baseline score.|Mixed Models Analysis||Placebo minus Concerta|||5.8|3.2|<0.0001
72396898|NCT00799487|144299687|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|9.5|||<|0.0001|TWO_SIDED|95.0|6.9|12.0||P-values were determined by using a repeated measures mixed model with actual value as the dependent variable with terms for treatment, time, treatment by time interaction, period, sequence, and baseline score.|Mixed Models Analysis||Placebo minus Concerta|||12.0|6.9|<0.0001
72396899|NCT00799487|144299688|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-3.51|||<|0.0001|TWO_SIDED|95.0|-4.27|-2.74||P-values were determined by using a general linear mixed model.|Mixed Models Analysis||Placebo minus Concerta|||-2.74|-4.27|<0.0001
72396900|NCT00799487|144299689|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-17.58|||<|0.0001|TWO_SIDED|95.0|-23.72|-11.45||P-values were determined by using a general linear mixed model.|Mixed Models Analysis||Placebo minus Concerta|||-11.45|-23.72|<0.0001
72396901|NCT00799487|144299690|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-30.33|||<|0.0001|TWO_SIDED|95.0|-39.29|-21.37||P-values were determined by using a general linear mixed model.|Mixed Models Analysis||Placebo minus Concerta|||-21.37|-39.29|<0.0001
72471679|NCT00474526|144466778|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of US1A over US1B, the lower limit of 95% CI for the difference in rates (PUS1A - PUS1B) had to be greater than -10%.|Percentage difference|-4.0|||||TWO_SIDED|95.0|-13.0|5.0|||ANOVA|||PnC 9V (percentage difference (US1A - US1B))||5|-13|
72471680|NCT00474526|144466778|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of US1A over US1B, the lower limit of 95% CI for the difference in rates (PUS1A - PUS1B) had to be greater than -10%.|Percentage difference|-1.0|||||TWO_SIDED|95.0|-6.0|3.0|||ANOVA|||PnC 14 (percentage difference (US1A - US1B))||3|-6|
72565698|NCT02709486|144662693|SUPERIORITY||Odds Ratio (OR)|2.23||||0.0107|TWO_SIDED|95.0|1.21|4.14|||Regression, Logistic|||Week 4, \>=70%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||4.14|1.21|0.0107
72565699|NCT02709486|144662693|SUPERIORITY||Odds Ratio (OR)|2.18||||0.0126|TWO_SIDED|95.0|1.18|4.02|||Regression, Logistic|||Week 4, \>=70%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||4.02|1.18|0.0126
72565700|NCT02709486|144662693|SUPERIORITY||Odds Ratio (OR)|2.67||||0.1516|TWO_SIDED|95.0|0.7|10.26|||Regression, Logistic|||Week 4, \>=90%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||10.26|0.70|0.1516
72565701|NCT02709486|144662693|SUPERIORITY||Odds Ratio (OR)|4.49||||0.021|TWO_SIDED|95.0|1.25|16.05|||Regression, Logistic|||Week 4, \>=90%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||16.05|1.25|0.0210
72565702|NCT02709486|144662693|SUPERIORITY||Odds Ratio (OR)|1.65||||0.0034|TWO_SIDED|95.0|1.18|2.31|||Regression, Logistic|||Week 8, \>=30%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.31|1.18|0.0034
72565703|NCT02709486|144662693|SUPERIORITY||Odds Ratio (OR)|1.75||||0.001|TWO_SIDED|95.0|1.26|2.45|||Regression, Logistic|||Week 8, \>=30%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.45|1.26|0.0010
72565704|NCT02709486|144662693|SUPERIORITY||Odds Ratio (OR)|1.86||||0.0014|TWO_SIDED|95.0|1.27|2.71|||Regression, Logistic|||Week 8, \>=50%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.71|1.27|0.0014
72565705|NCT02709486|144662693|SUPERIORITY||Odds Ratio (OR)|2.13|||<|0.0001|TWO_SIDED|95.0|1.46|3.1|||Regression, Logistic|||Week 8, \>=50%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.10|1.46|<.0001
72396902|NCT00799487|144299691|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.13||||0.0297|TWO_SIDED|95.0|-2.15|-0.12||P-values were determined by using a general linear mixed model.|Mixed Models Analysis||Placebo minus Concerta|||-0.12|-2.15|0.0297
72396903|NCT00799487|144299692|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.84||||0.0955|TWO_SIDED|95.0|-1.84|0.15||P-values were determined by using a general linear mixed model. Finger Windows Forwards was the first non-significant p-value in the gatekeeper sequence.|Mixed Models Analysis|Testing of additional endpoints in the sequence was still performed without any unqualified statements about the individual statistical significance.|Placebo minus Concerta|||0.15|-1.84|0.0955
72396904|NCT00799487|144299693|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-14.37||||0.0002|TWO_SIDED|95.0|-21.52|-7.23||P-values were determined by using a general linear mixed model.|Mixed Models Analysis||Placebo minus Concerta|||-7.23|-21.52|0.0002
72396905|NCT00799487|144299694|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.26||||0.2335|TWO_SIDED|95.0|-0.7|0.17||P-values were determined by using a general linear mixed model.|Mixed Models Analysis||Placebo minus Concerta|||0.17|-0.70|0.2335
72396906|NCT00799487|144299695|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-2.51||||0.2321|TWO_SIDED|95.0|-6.67|1.65||P-values were determined by using a general linear mixed model.|Mixed Models Analysis||Placebo minus Concerta|||1.65|-6.67|0.2321
72396907|NCT00799487|144299696|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-3.52||||0.0015|TWO_SIDED|95.0|-5.64|-1.4||P-values were determined by using a general linear mixed model.|Mixed Models Analysis||Placebo minus Concerta|||-1.40|-5.64|0.0015
72396908|NCT00799487|144299697|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-5.38||||0.0101|TWO_SIDED|95.0|-9.43|-1.33||P-values were determined by using a general linear mixed model.|Mixed Models Analysis||Placebo minus Concerta|||-1.33|-9.43|0.0101
72565706|NCT02709486|144662693|SUPERIORITY||Odds Ratio (OR)|2.61||||0.0007|TWO_SIDED|95.0|1.49|4.55|||Regression, Logistic|||Week 8, \>=70%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||4.55|1.49|0.0007
72565707|NCT02709486|144662693|SUPERIORITY||Odds Ratio (OR)|2.43||||0.0018|TWO_SIDED|95.0|1.39|4.24|||Regression, Logistic|||Week 8, \>=70%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||4.24|1.39|0.0018
72565708|NCT02709486|144662693|SUPERIORITY||Odds Ratio (OR)|4.1||||0.015|TWO_SIDED|95.0|1.31|12.79|||Regression, Logistic|||Week 8, \>=90%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||12.79|1.31|0.0150
72565709|NCT02709486|144662693|SUPERIORITY||Odds Ratio (OR)|3.79||||0.0211|TWO_SIDED|95.0|1.22|11.78|||Regression, Logistic|||Week 8, \>=90%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||11.78|1.22|0.0211
72565710|NCT02709486|144662693|SUPERIORITY||Odds Ratio (OR)|2.01|||<|0.0001|TWO_SIDED|95.0|1.43|2.84|||Regression, Logistic|||Week 12, \>=30%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.84|1.43|<.0001
72565711|NCT02709486|144662693|SUPERIORITY||Odds Ratio (OR)|2.19|||<|0.0001|TWO_SIDED|95.0|1.55|3.1|||Regression, Logistic|||Week 12, \>=30%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.10|1.55|<.0001
72565712|NCT02709486|144662693|SUPERIORITY||Odds Ratio (OR)|2.1|||<|0.0001|TWO_SIDED|95.0|1.47|3.0|||Regression, Logistic|||Week 12, \>=50%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.00|1.47|<.0001
72565713|NCT02709486|144662693|SUPERIORITY||Odds Ratio (OR)|2.08|||<|0.0001|TWO_SIDED|95.0|1.46|2.96|||Regression, Logistic|||Week 12, \>=50%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.96|1.46|<.0001
72565714|NCT02709486|144662693|SUPERIORITY||Odds Ratio (OR)|1.74||||0.018|TWO_SIDED|95.0|1.1|2.76|||Regression, Logistic|||Week 12, \>=70%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.76|1.10|0.0180
72565715|NCT02709486|144662693|SUPERIORITY||Odds Ratio (OR)|1.86||||0.0072|TWO_SIDED|95.0|1.18|2.94|||Regression, Logistic|||Week 12, \>=70%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.94|1.18|0.0072
72565716|NCT02709486|144662693|SUPERIORITY||Odds Ratio (OR)|10.84||||0.0015|TWO_SIDED|95.0|2.49|47.22|||Regression, Logistic|||Week 12, \>=90%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||47.22|2.49|0.0015
72565717|NCT02709486|144662693|SUPERIORITY||Odds Ratio (OR)|8.62||||0.0044|TWO_SIDED|95.0|1.96|37.96|||Regression, Logistic|||Week 12, \>=90%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||37.96|1.96|0.0044
72565718|NCT02709486|144662693|SUPERIORITY||Odds Ratio (OR)|1.72||||0.0018|TWO_SIDED|95.0|1.22|2.43|||Regression, Logistic|||Week 16, \>=30%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.43|1.22|0.0018
72565719|NCT02709486|144662693|SUPERIORITY||Odds Ratio (OR)|1.77||||0.0011|TWO_SIDED|95.0|1.26|2.5|||Regression, Logistic|||Week 16, \>=30%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.50|1.26|0.0011
72396909|NCT00799487|144299698|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.09||||0.6642|TWO_SIDED|95.0|-0.53|0.34||P-values were determined by using a general linear mixed model.|Mixed Models Analysis||Placebo minus Concerta|||0.34|-0.53|0.6642
72565720|NCT02709486|144662693|SUPERIORITY||Odds Ratio (OR)|1.68||||0.0035|TWO_SIDED|95.0|1.19|2.38|||Regression, Logistic|||Week 16, \>=50%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.38|1.19|0.0035
72565721|NCT02709486|144662693|SUPERIORITY||Odds Ratio (OR)|1.72||||0.0022|TWO_SIDED|95.0|1.22|2.43|||Regression, Logistic|||Week 16, \>=50%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.43|1.22|0.0022
72565722|NCT02709486|144662693|SUPERIORITY||Odds Ratio (OR)|1.74||||0.0155|TWO_SIDED|95.0|1.11|2.72|||Regression, Logistic|||Week 16, \>=70%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.72|1.11|0.0155
72565723|NCT02709486|144662693|SUPERIORITY||Odds Ratio (OR)|1.39||||0.1549|TWO_SIDED|95.0|0.88|2.2|||Regression, Logistic|||Week 16, \>=70%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.20|0.88|0.1549
72396910|NCT00799487|144299699|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-35.3||||0.004|TWO_SIDED|95.0|-58.89|-11.71||P-values were determined by using a general linear mixed model.|Mixed Models Analysis||Placebo minus Concerta|||-11.71|-58.89|0.0040
72565724|NCT02709486|144662693|SUPERIORITY||Odds Ratio (OR)|2.94||||0.0212|TWO_SIDED|95.0|1.18|7.37|||Regression, Logistic|||Week 16, \>=90%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||7.37|1.18|0.0212
72565725|NCT02709486|144662693|SUPERIORITY||Odds Ratio (OR)|2.64||||0.0373|TWO_SIDED|95.0|1.06|6.57|||Regression, Logistic|||Week 16, \>=90%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||6.57|1.06|0.0373
72396911|NCT00799487|144299700|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.08||||0.0012|TWO_SIDED|95.0|-0.14|-0.03||P-values were determined by using a general linear mixed model.|Mixed Models Analysis||Placebo minus Concerta|||-0.03|-0.14|0.0012
72396912|NCT00799487|144299701|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.07||||0.0051|TWO_SIDED|95.0|-0.12|-0.02||P-values were determined by using a general linear mixed model.|Mixed Models Analysis||Placebo minus Concerta|||-0.02|-0.12|0.0051
72396913|NCT00799487|144299702|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.05||||0.1768|TWO_SIDED|95.0|-0.13|0.02||P-values were determined by using a general linear mixed model.|Mixed Models Analysis||Placebo minus Concerta|||0.02|-0.13|0.1768
72396914|NCT00799487|144299703|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.02||||0.4245|TWO_SIDED|95.0|-0.09|0.04||P-values were determined by using a general linear mixed model.|Mixed Models Analysis||Placebo minus Concerta|||0.04|-0.09|0.4245
72396915|NCT00799487|144299704|SUPERIORITY_OR_OTHER_LEGACY||LS Mean DIfference|0.0||||0.9729|TWO_SIDED|95.0|-0.09|0.09||P-values were determined by using a general linear mixed model.|Mixed Models Analysis||Placebo minus Concerta|||0.09|-0.09|0.9729
72396916|NCT00799487|144299705|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.04||||0.3486|TWO_SIDED|95.0|-0.12|0.04||P-values were determined by using a general linear mixed model.|Mixed Models Analysis||Placebo minus Concerta|||0.04|-0.12|0.3486
72396917|NCT00799487|144299706|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.03||||0.1466|TWO_SIDED|95.0|-0.07|0.01||P-values were determined by using a general linear mixed model.|Mixed Models Analysis||Placebo minus Concerta|||0.01|-0.07|0.1466
72396918|NCT00799487|144299707|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.03||||0.1368|TWO_SIDED|95.0|-0.01|0.08||P-values were determined by using a general linear mixed model.|Mixed Models Analysis||Placebo minus Concerta|||0.08|-0.01|0.1368
72396919|NCT02436889|144299768|SUPERIORITY|||||||0.949|||||||ANCOVA|||||||0.949
72396920|NCT02436889|144299769|SUPERIORITY||Mean Difference (Final Values)|3.11||||0.2415|TWO_SIDED|95.0|-2.09|8.31|||ANCOVA|change from baseline, adjusted for baseline value||||8.31|-2.09|0.2415
72396921|NCT02436889|144299770|SUPERIORITY||Mean Difference (Final Values)|-12.01||||0.0001|TWO_SIDED|95.0|-18.16|-5.87|||ANCOVA|||||-5.87|-18.16|0.0001
72396922|NCT02436889|144299771|SUPERIORITY||Mean Difference (Final Values)|-0.63||||0.1956|TWO_SIDED|95.0|-1.59|0.33|||ANCOVA|||||0.33|-1.59|0.1956
72396923|NCT02436889|144299772|SUPERIORITY||Mean Difference (Final Values)|1.87||||0.0168|TWO_SIDED|95.0|0.34|3.4|||ANCOVA|||||3.40|0.34|0.0168
72506058|NCT02531035|144543717|SUPERIORITY||Least squares mean difference|-12.32|||<|0.001|TWO_SIDED|95.0|-18.17|-6.48|||MMRM|||Testing according to hierarchical procedure. Post-Baseline LS means and p-values were obtained from MMRM model with treatment, randomization stratum of BMI at Screening (\<25 kg/m2, \>=25 kg/m2), randomization stratum of Week -2 A1C (\<=9.0%, \>9.0%), randomization stratum of use of CSII at Screening (yes, no), time (study week), a treatment-by-time interaction as fixed categorical effects, and Baseline mean daily bolus insulin dose-by-time interaction as a covariate.||-6.48|-18.17|< 0.001
72506059|NCT03567291|144543777|SUPERIORITY||Mean Difference (Final Values)|-0.4||||0.78|TWO_SIDED|95.0|-3.4|2.6|||ANCOVA|||||2.6|-3.4|0.78
72396924|NCT02436889|144299773|SUPERIORITY||Mean Difference (Final Values)|2.1||||0.0101|TWO_SIDED|95.0|0.5|3.71|||ANCOVA|||||3.71|0.50|0.0101
72396925|NCT01084174|144299777|OTHER|||||||0.003|||||||Regression, Linear|Analyzed by linear regression models using generalized estimating equations to account for repeated measures over time with robust standard errors||||||.003
72396926|NCT01084174|144299778|OTHER||||||<|0.001|||||||Regression, Linear|||||||<.001
72396927|NCT01084174|144299779|OTHER||||||<|0.001|||||||Regression, Linear|||||||<.001
72396928|NCT01084174|144299780|OTHER|||||||0.4|||||||Regression, Linear|||||||0.40
72396929|NCT01084174|144299781|OTHER|||||||0.07|||||||Regression, Linear|||||||.07
72396930|NCT01084174|144299782|OTHER|||||||0.007|||||||Regression, Linear|||||||.007
72396931|NCT02289898|144299786|SUPERIORITY||Hazard Ratio (HR)|0.93|||=|0.7158|TWO_SIDED|95.0|0.63|1.375|||Wilcoxon (Mann-Whitney)|||Efficacy (investigator-assessed Kaplan-Meier estimates of progression-free survival) of placebo/placebo arm to the pooled demcizumab arm (i.e., placebo/placebo arm to demcizumab/placebo and demcizumab/demcizumab arms) in subjects with first-line metastatic pancreatic ductal adenocarcinoma.||1.375|0.630|=0.7158
72396932|NCT02611778|144299787|EQUIVALENCE|The confidence interval (CI) for treatment difference (FYB201 - Lucentis) was calculated using Least Square Means. If the 90% CI was completely contained in the interval \]-3.5;3.5\[ ETDRS letters, equivalence of FYB201 and Lucentis could be concluded.|Difference in least square means|-0.4|STANDARD_ERROR_OF_MEAN|0.76|||TWO_SIDED|90.0|-1.6|0.9|||ANCOVA||An ANCOVA model was used for the analysis with the change in BCVA between baseline and Week 8 as the dependent variable, the baseline BCVA as covariate, and (pooled) country and treatment group as fixed effects.|The hypothesis of biosimilarity of FYB201 and Lucentis was tested with a two-sided equivalence test with an equivalence margin of 3 ETDRS letters. An ANCOVA model was used with the change in BCVA between baseline and Week 8 as the dependent variable, the baseline BCVA as covariate, and the country and the treatment group as fixed effects.||0.9|-1.6|
72396933|NCT02611778|144299788|OTHER||Difference in least square means|0.0|STANDARD_ERROR_OF_MEAN|0.96|||TWO_SIDED|90.0|-1.6|1.5|||ANCOVA||An ANCOVA model was used for the analysis with the change in BCVA between baseline and Week 24 as the dependent variable, the baseline BCVA as covariate, and (pooled) country and treatment group as fixed effects.|There was no formal hypothesis testing.||1.5|-1.6|
72396934|NCT02611778|144299789|OTHER||Difference in least square means|-0.1|STANDARD_ERROR_OF_MEAN|1.08|||TWO_SIDED|90.0|-1.8|1.7|||ANCOVA||An ANCOVA model was used for the analysis with the change in BCVA between baseline and Week 48 as the dependent variable, the baseline BCVA as covariate, and (pooled) country and treatment group as fixed effects.|There was no formal hypothesis testing.||1.7|-1.8|
72396935|NCT02611778|144299790|OTHER||Difference in least square means|0.1|STANDARD_ERROR_OF_MEAN|1.04|||TWO_SIDED|90.0|-1.6|1.8|||ANCOVA||An ANCOVA model was used for the analysis with the change in BCVA between baseline and 12 months (average of Weeks 40, 44 and 48) as the dependent variable, the baseline BCVA as covariate, and (pooled) country and treatment group as fixed effects.|There was no formal hypothesis testing.||1.8|-1.6|
72396936|NCT02611778|144299791|OTHER||Difference in least square means|0.69|STANDARD_ERROR_OF_MEAN|11.469|||TWO_SIDED|90.0|-18.22|19.6|||ANCOVA||An ANCOVA model was used for the analysis with the change in FCP retinal thickness between baseline and Week 24 as the dependent variable, the baseline FCP retinal thickness as covariate, and (pooled) country and treatment group as fixed effects.|There was no formal hypothesis testing.||19.60|-18.22|
72396937|NCT02611778|144299792|OTHER||Difference in least square means|2.68|STANDARD_ERROR_OF_MEAN|11.632|||TWO_SIDED|90.0|-16.49|21.85|||ANCOVA||An ANCOVA model was used for the analysis with the change in FCP retinal thickness between baseline and Week 48 as the dependent variable, the baseline FCP retinal thickness as covariate, and (pooled) country and treatment group as fixed effects.|There was no formal hypothesis testing.||21.85|-16.49|
72396938|NCT02611778|144299793|OTHER||Difference in least square means|-5.91|STANDARD_ERROR_OF_MEAN|10.136|||TWO_SIDED|90.0|-22.62|10.8|||ANCOVA||An ANCOVA model was used for the analysis with the change in FCS retinal thickness between baseline and Week 24 as the dependent variable, the baseline FCS retinal thickness as covariate, and (pooled) country and treatment group as fixed effects.|There was no formal hypothesis testing.||10.80|-22.62|
72396939|NCT02611778|144299794|OTHER||Difference in least square means|3.68|STANDARD_ERROR_OF_MEAN|10.285|||TWO_SIDED|90.0|-13.28|20.63|||ANCOVA||An ANCOVA model was used for the analysis with the change in FCS retinal thickness between baseline and Week 48 as the dependent variable, the baseline FCS retinal thickness as covariate, and (pooled) country and treatment group as fixed effects.|There was no formal hypothesis testing.||20.63|-13.28|
72396940|NCT02611778|144299795|OTHER||Difference in least square means|0.07|STANDARD_ERROR_OF_MEAN|0.4709|||TWO_SIDED|90.0|-0.706|0.846|||ANCOVA||An ANCOVA model was used for the analysis with the change in total lesion area between baseline and Week 24 as the dependent variable, the baseline total lesion area as covariate, and (pooled) country and treatment group as fixed effects.|There was no formal hypothesis testing.||0.846|-0.706|
72396941|NCT02611778|144299796|OTHER||Difference in least square means|0.342|STANDARD_ERROR_OF_MEAN|0.5387|||TWO_SIDED|90.0|-0.547|1.23|||ANCOVA||An ANCOVA model was used for the analysis with the change in total lesion area between baseline and Week 48 as the dependent variable, the baseline total lesion area as covariate, and (pooled) country and treatment group as fixed effects.|There was no formal hypothesis testing.||1.230|-0.547|
72396942|NCT02611778|144299797|OTHER||Difference in least square means|0.21|STANDARD_ERROR_OF_MEAN|0.886|||TWO_SIDED|90.0|-1.25|1.67|||ANCOVA||An ANCOVA model was used for the analysis with change in NEI VFQ-25 composite score between baseline and Week 24 as dependent variable, baseline NEI VFQ-25 composite score as covariate, and (pooled) country and treatment group as fixed effects.|There was no formal hypothesis testing.||1.67|-1.25|
72396943|NCT02611778|144299798|OTHER||Difference in least square means|1.73|STANDARD_ERROR_OF_MEAN|1.027|||TWO_SIDED|90.0|0.04|3.42|||ANCOVA||An ANCOVA model was used for the analysis with change in NEI VFQ-25 composite score between baseline and Week 48 as dependent variable, baseline NEI VFQ-25 composite score as covariate, and (pooled) country and treatment group as fixed effects.|There was no formal hypothesis testing.||3.42|0.04|
72565726|NCT02709486|144662693|SUPERIORITY||Odds Ratio (OR)|1.83||||0.0006|TWO_SIDED|95.0|1.29|2.57|||Regression, Logistic|||Week 24, \>=30%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.57|1.29|0.0006
72565727|NCT02709486|144662693|SUPERIORITY||Odds Ratio (OR)|2.13|||<|0.0001|TWO_SIDED|95.0|1.51|3.02|||Regression, Logistic|||Week 24, \>=30%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.02|1.51|<.0001
72396944|NCT02663232|144299833|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|TWO_SIDED||||||Bivariate regression analysis|Bivariate regression analysis of clinical risk factors for BRAF mutation||The association of Melanoma Stage (IIIC \[referral category\] versus (vs) M1a vs M1b vs M1c) with the risk of BRAF mutation (Yes/No) was assessed using bivariate regression analysis.||||0.001
72396945|NCT02663232|144299833|SUPERIORITY_OR_OTHER_LEGACY|||||||0.196|TWO_SIDED||||||Bivariate regression analysis|Bivariate regression analysis of clinical risk factors for BRAF mutation||The association of Melanoma Stage IIIC/M1a/M1b \[referral category\] vs M1c with the risk of BRAF mutation (Yes/No) was assessed using bivariate regression analysis.||||0.196
72396946|NCT02663232|144299833|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002|TWO_SIDED||||||Multivariate regression analysis|Multivariate regression analysis of clinical risk factors for BRAF mutation||The association of Melanoma Stage IIIc with the risk of BRAF mutation (Yes/No) was assessed using multivariate regression analysis.||||0.002
72396947|NCT02663232|144299833|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|2.716||||0.028|TWO_SIDED|95.0|1.115|6.616|||Multivariate regression analysis|Multivariate regression analysis of clinical risk factors for BRAF mutation (n=184)||The association of Melanoma Stage M1a (using Melanoma Stage IIIC as referral category) with the risk of BRAF mutation (Yes/No) was assessed using multivariate regression analysis.||6.616|1.115|0.028
72396948|NCT02663232|144299833|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.466||||0.142|TWO_SIDED|95.0|0.168|1.291|||Multivariate regression analysis|Multivariate regression analysis of clinical risk factors for BRAF mutation (n=184)||The association of Melanoma Stage M1b (using Melanoma Stage IIIC as referral category) with the risk of BRAF mutation (Yes/No) was assessed using multivariate regression analysis.||1.291|0.168|0.142
72565728|NCT02709486|144662693|SUPERIORITY||Odds Ratio (OR)|1.54||||0.0152|TWO_SIDED|95.0|1.09|2.18|||Regression, Logistic|||Week 24, \>=50%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.18|1.09|0.0152
72396949|NCT02663232|144299833|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.822||||0.653|TWO_SIDED|95.0|0.351|1.928|||Multivariate regression analysis|Multivariate regression analysis of clinical risk factors for BRAF mutation (n=184)||The association of Melanoma Stage M1c (using Melanoma Stage IIIC as referral category) with the risk of BRAF mutation (Yes/No) was assessed using multivariate regression analysis.||1.928|0.351|0.653
72396950|NCT02663232|144299834|SUPERIORITY_OR_OTHER_LEGACY|||||||0.24|TWO_SIDED||||||Bivariate regression analysis|Bivariate regression analysis of clinical risk factors for BRAF mutation||The association of Family family history of melanoma (yes vs no) with the risk of BRAF mutation (Yes/No) was assessed using bivariate regression analysis.||||0.240
72396951|NCT02663232|144299835|SUPERIORITY_OR_OTHER_LEGACY|||||||0.719|TWO_SIDED||||||Bivariate regression analysis|Bivariate regression analysis of clinical risk factors for BRAF mutation||The association of sun exposure yes vs no with the risk of BRAF mutation (Yes/No) was assessed using bivariate regression analysis.||||0.719
72396952|NCT02663232|144299836|SUPERIORITY_OR_OTHER_LEGACY|||||||0.262|TWO_SIDED||||||Bivariate regression analysis|Bivariate regression analysis of clinical risk factors for BRAF mutation||The association of primary tumor site (trunk \[referral category\] vs head and neck vs upper extremities vs lower extremities vs. visceral/mucosa) with the risk of BRAF mutation (Yes/No) was assessed using bivariate regression analysis.||||0.262
72396953|NCT02663232|144299837|SUPERIORITY_OR_OTHER_LEGACY|||||||0.313|TWO_SIDED||||||Bivariate regression analysis|Bivariate regression analysis of clinical risk factors for BRAF mutation||The association of LDH (elevated \[referral category\] vs normal vs unknown) with the risk of BRAF mutation (Yes/No) was assessed using bivariate regression analysis.||||0.313
72396954|NCT02663232|144299838|SUPERIORITY_OR_OTHER_LEGACY|||||||0.291|TWO_SIDED||||||Bivariate regression analysis|Bivariate regression analysis of clinical risk factors for BRAF mutation||The association of time since diagnosis of primary melanoma (continuous variable) with the risk of BRAF mutation (Yes/No) was assessed using bivariate regression analysis.||||0.291
72396955|NCT02663232|144299839|SUPERIORITY_OR_OTHER_LEGACY|||||||0.164|TWO_SIDED||||||Bivariate regression analysis|Bivariate regression analysis of anatomopathological risk factors for BRAF mutation||The association of tumor sample source (primary tumor \[referral category\] vs metastases vs relapses) with the risk of BRAF mutation (Yes/No) was assessed using bivariate regression analysis.||||0.164
72396956|NCT02663232|144299840|SUPERIORITY_OR_OTHER_LEGACY|||||||0.505|TWO_SIDED||||||Bivariate regression analysis|Bivariate regression analysis of anatomopathological risk factors for BRAF mutation||The association of tumor sample type (paraffin-embedded blocks \[referral category\] vs slides of paraffin blocks vs cytology slides) with the risk of BRAF mutation (Yes/No) was assessed using bivariate regression analysis.||||0.505
72396957|NCT02663232|144299841|SUPERIORITY_OR_OTHER_LEGACY|||||||0.701|TWO_SIDED||||||Bivariate regression analysis|Bivariate regression analysis of anatomopathological risk factors for BRAF mutation||The association of method of fixation (buffered formalin \[referral category\] vs other) with the risk of BRAF mutation (Yes/No) was assessed using bivariate regression analysis.||||0.701
72396958|NCT02663232|144299842|SUPERIORITY_OR_OTHER_LEGACY|||||||0.683|TWO_SIDED||||||Bivariate regression analysis|Bivariate regression analysis of anatomopathological risk factors for BRAF mutation||The association of Berslow thickness (≤1 mm \[referral category\] vs 1.01-2 mm vs 2.01-4 mm vs 4 mm) with the risk of BRAF mutation (Yes/No) was assessed using bivariate regression analysis.||||0.683
72396959|NCT02663232|144299843|SUPERIORITY_OR_OTHER_LEGACY|||||||0.615|TWO_SIDED||||||Bivariate regression analysis|Bivariate regression analysis of anatomopathological risk factors for BRAF mutation||The association of Ulceration (no \[referral category\] vs yes) with the risk of BRAF mutation (Yes/No) was assessed using bivariate regression analysis.||||0.615
72396960|NCT02663232|144299844|SUPERIORITY_OR_OTHER_LEGACY|||||||0.949|TWO_SIDED||||||Bivariate regression analysis|Bivariate regression analysis of anatomopathological risk factors for BRAF mutation||The association of presence of regression (Without regression \[referral category\] vs With regression) with the risk of BRAF mutation (Yes/No) was assessed using bivariate regression analysis.||||0.949
72396961|NCT02663232|144299845|SUPERIORITY_OR_OTHER_LEGACY|||||||0.374|TWO_SIDED||||||Bivariate regression analysis|Bivariate regression analysis of anatomopathological risk factors for BRAF mutation||The association of Vascular invasion (Without vascular invasion \[referral category\] vs With vascular invasion) with the risk of BRAF mutation (Yes/No) was assessed using bivariate regression analysis.||||0.374
72396962|NCT03336853|144299879|SUPERIORITY||Mean Difference (Final Values)|0.74|||<|0.0001|TWO_SIDED|95.0|0.66|0.82|||t-test, 2 sided|||||0.82|0.66|<.0001
72622929|NCT01469156|144776018|OTHER|Visually significant ocular or systemic AEs were predominantly mild or moderate. No significant safety signals were observed in either group.High- and standard-dose ranibizumab were generally well tolerated without evidence of ocular or systemic severe adverse events, including arterial thromboembolic events.|data survey|28.0||||0.05|TWO_SIDED|95.0|0.0|28.0||28 ocular and non-ocular adverse events collected, in mild to moderate nature|t-test, 2 sided|||Purpose was to determine safety and efficacy of intravitreal high-dose ranibizumab in the treatment of active PCV.|Visually significant ocular or systemic AEs that were either reported by subjects or identified by imaging and/or ocular exam|28|0|0.05
72622930|NCT03926247|144776089|OTHER|Within-group longitudinal analysis (no comparison groups)|LSM Final Difference|-0.044|STANDARD_ERROR_OF_MEAN|0.019|=|0.019|TWO_SIDED|95.0|-0.087|-0.008|||Mixed Models Analysis|||Analyses were conducted using a mixed effects linear model to calculate least square means across the 4 timepoints. This was a longitudinal within-group analysis with 4 timepoints of data nested within 56 individuals. Our hypothesis was that participants' depression/anxiety symptoms would decrease overtime.||-0.008|-0.087|=0.019
72396963|NCT04772755|144299893|SUPERIORITY|||||||0.0249|||||||Chi-squared|||||||0.0249
72396964|NCT04772755|144299894|SUPERIORITY|||||||0.8918|||||||Mantel Haenszel|||||||0.8918
72396965|NCT04772755|144299895|SUPERIORITY|||||||0.6587|||||||Wilcoxon (Mann-Whitney)|||||||0.6587
72396966|NCT04772755|144299896|SUPERIORITY|||||||0.0059|||||||Wilcoxon (Mann-Whitney)|||||||0.0059
72396967|NCT04772755|144299897|SUPERIORITY|||||||0.1647|||||||Chi-squared|||||||0.1647
72396968|NCT04772755|144299898|SUPERIORITY|||||||0.009|||||||Chi-squared|||||||0.0090
72396969|NCT04772755|144299899|SUPERIORITY|||||||0.0273|||||||Wilcoxon (Mann-Whitney)|||||||0.0273
72396970|NCT04772755|144299900|SUPERIORITY|||||||0.0458|||||||Chi-squared|||||||0.0458
72396971|NCT04772755|144299901|SUPERIORITY|||||||0.0976|||||||Chi-squared|||||||0.0976
72396972|NCT01905657|144299906|SUPERIORITY_OR_OTHER_LEGACY|Hazard Ratio based on stratified Cox regression model with treatment as a covariate and p-value based on stratified log-rank test, in accordance with the statistical analysis plan.|Hazard Ratio (HR)|0.54||||0.00024|TWO_SIDED|95.0|0.38|0.77|||Log Rank||Numerator=Pembrolizumab 2 mg/kg Denominator=Docetaxel 75 mg/m\^2|In participants with strongly PD-L1 positive tumors||0.77|0.38|0.00024
72396973|NCT01905657|144299906|SUPERIORITY_OR_OTHER_LEGACY|Hazard Ratio based on stratified Cox regression model with treatment as a covariate and p-value based on stratified log-rank test, in accordance with the statistical analysis plan.|Hazard Ratio (HR)|0.5||||2e-05|TWO_SIDED|95.0|0.36|0.7|||Log Rank||Numerator=Pembrolizumab 10 mg/kg Denominator=Docetaxel 75 mg/m\^2|In participants with strongly PD-L1 positive tumors||0.70|0.36|0.00002
72471681|NCT00474526|144466778|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of US1A over US1B, the lower limit of 95% CI for the difference in rates (PUS1A - PUS1B) had to be greater than -10%.|Percentage difference|-6.0|||||TWO_SIDED|95.0|-15.0|3.0|||ANOVA|||PnC 18C (percentage difference (US1A:US1B))||3|-15|
72396974|NCT01905657|144299906|SUPERIORITY_OR_OTHER_LEGACY|Hazard Ratio based on stratified Cox regression model with treatment as a covariate and p-value based on stratified log-rank test, in accordance with the statistical analysis plan.|Hazard Ratio (HR)|0.71||||0.00076|TWO_SIDED|95.0|0.58|0.88|||Log Rank||Numerator=Pembrolizumab 2 mg/kg Denominator=Docetaxel 75 mg/m\^2|In participants with PD-L1 positive tumors||0.88|0.58|0.00076
72396975|NCT01905657|144299906|SUPERIORITY_OR_OTHER_LEGACY|Hazard Ratio based on stratified Cox regression model with treatment as a covariate and p-value based on stratified log-rank test, in accordance with the statistical analysis plan.|Hazard Ratio (HR)|0.61|||<|1e-05|TWO_SIDED|95.0|0.49|0.75|||Log Rank||Numerator=Pembrolizumab 10 mg/kg Denominator=Docetaxel 75 mg/m\^2|In participants with PD-L1 positive tumors||0.75|0.49|<0.00001
72396976|NCT01905657|144299907|SUPERIORITY_OR_OTHER_LEGACY|Hazard Ratio based on stratified Cox regression model with treatment as a covariate and p-value based on stratified log-rank test, in accordance with the statistical analysis plan.|Hazard Ratio (HR)|0.58||||9e-05|TWO_SIDED|95.0|0.43|0.77|||Log Rank||Numerator=Pembrolizumab 2 mg/kg Denominator=Docetaxel 75 mg/m\^2|In participants with strongly PD-L1 positive tumors||0.77|0.43|0.00009
72396977|NCT01905657|144299907|SUPERIORITY_OR_OTHER_LEGACY|Hazard Ratio based on stratified Cox regression model with treatment as a covariate and p-value based on stratified log-rank test, in accordance with the statistical analysis plan.|Hazard Ratio (HR)|0.59||||7e-05|TWO_SIDED|95.0|0.45|0.78|||Log Rank||Numerator=Pembrolizumab 10 mg/kg Denominator=Docetaxel 75 mg/m\^2|In participants with strongly PD-L1 positive tumors||0.78|0.45|0.00007
72396978|NCT01905657|144299907|SUPERIORITY_OR_OTHER_LEGACY|Hazard Ratio based on stratified Cox regression model with treatment as a covariate and p-value based on stratified log-rank test, in accordance with the statistical analysis plan.|Hazard Ratio (HR)|0.88||||0.06758|TWO_SIDED|95.0|0.73|1.04|||Log Rank||Numerator=Pembrolizumab 2 mg/kg Denominator=Docetaxel 75 mg/m\^2|In participants with PD-L1 positive tumors||1.04|0.73|0.06758
72396979|NCT01905657|144299907|SUPERIORITY_OR_OTHER_LEGACY|Hazard Ratio based on stratified Cox regression model with treatment as a covariate and p-value based on stratified log-rank test, in accordance with the statistical analysis plan.|Hazard Ratio (HR)|0.79||||0.00462|TWO_SIDED|95.0|0.66|0.94|||Log Rank||Numerator=Pembrolizumab 10 mg/kg Denominator=Docetaxel 75 mg/m\^2|In participants with PD-L1 positive tumors||0.94|0.66|0.00462
72396980|NCT01905657|144299910|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentages|-2.3||||0.66608|TWO_SIDED|95.0|-12.7|8.2||P-value indicated for testing a difference in percentage equal to 0 versus a difference in percentage not equal to 0, in accordance with the statistical analysis plan.|Miettinen & Nurminen method||This is an adjusted risk difference estimated by stratified Miettinen \& Nurminen method.|In participants with strongly PD-L1 positive tumors||8.2|-12.7|0.66608
72396981|NCT01905657|144299910|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentages|22.2|||<|1e-05|TWO_SIDED|95.0|14.0|30.7||P-value indicated for testing a difference in percentage equal to 0 versus a difference in percentage greater than 0, in accordance with the statistical analysis plan.|Miettinen & Nurminen method||This is an adjusted risk difference estimated by stratified Miettinen \& Nurminen method.|In participants with strongly PD-L1 positive tumors||30.7|14.0|<0.00001
72396982|NCT01905657|144299910|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentages|8.7||||0.00045|TWO_SIDED|95.0|3.6|13.9||P-value indicated for testing a difference in percentage equal to 0 versus a difference in percentage greater than 0, in accordance with the statistical analysis plan.|Miettinen & Nurminen method||This is an adjusted risk difference estimated by stratified Miettinen \& Nurminen method.|In participants with PD-L1 positive tumors||13.9|3.6|0.00045
72396983|NCT01905657|144299910|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentages|9.1||||0.00024|TWO_SIDED|95.0|4.1|14.3||P-value indicated for testing a difference in percentage equal to 0 versus a difference in percentage greater than 0, in accordance with the statistical analysis plan.|Miettinen & Nurminen method||This is an adjusted risk difference estimated by stratified Miettinen \& Nurminen method.|In participants with PD-L1 positive tumors||14.3|4.1|0.00024
72396984|NCT02927080|144299959|SUPERIORITY|Percent Change in Total Muscle Volume (TMV) of the TA muscle in patients with FSHD administered ACE-083 when compared to placebo During Part 2 (randomized, controlled portion)|Mean Difference (Net)|9.54|STANDARD_ERROR_OF_MEAN|3.876||0.0138|TWO_SIDED|90.0|3.17|15.92|||ANCOVA|||D190 Percent change from baseline in TMV||15.92|3.17|0.0138
72396985|NCT02927080|144299959|SUPERIORITY|Percent Change in Total Muscle Volume (TMV) of the BB muscle in patients with FSHD administered ACE-083 when compared to placebo During Part 2 (randomized, controlled portion)|Mean Difference (Net)|16.39|STANDARD_ERROR_OF_MEAN|4.032|<|0.0001|TWO_SIDED|90.0|9.75|23.02|||ANCOVA|||D190 Percent change from baseline in TMV||23.02|9.75|<0.0001
72396986|NCT02927080|144299961|SUPERIORITY||Mean Difference (Final Values)|-2.73|STANDARD_ERROR_OF_MEAN|1.299||0.0359|TWO_SIDED|90.0|-4.86|-0.59|||ANCOVA|||D190 Absolute change from baseline in FF for the TA group administered ACE-083 when compared to Placebo in part 2||-0.59|-4.86|0.0359
72506060|NCT01103349|144543778|SUPERIORITY||Adjusted mean treatment differences|3.87|STANDARD_DEVIATION|1.494||0.005|TWO_SIDED|95.0|0.931|6.809||α=0.025 one-sided|Mixed Models Analysis|MMRM with baseline, treatment, day, treatment by day interaction and baseline by day interaction as fixed effects and patient as a random effect.||H0: Mean FEV1 % predicted trough change from baseline (BI671800 ED 400 mg bid) ≤ Mean FEV1 % predicted trough change from baseline (placebo)||6.809|0.931|0.0050
72396987|NCT02927080|144299961|SUPERIORITY||Mean Difference (Final Values)|-1.25|STANDARD_ERROR_OF_MEAN|1.359||0.3582|TWO_SIDED|90.0|-3.49|0.99|||ANCOVA|||D190 Absolute change from baseline in FF for the BB group administered ACE-083 when compared to Placebo in part 2||0.99|-3.49|0.3582
72396988|NCT02927080|144299962|SUPERIORITY||Mean Difference (Final Values)|-5.28|STANDARD_ERROR_OF_MEAN|4.068||0.1945|TWO_SIDED|90.0|-11.97|1.41|||ANCOVA|||D190 Percent change from baseline in 6 Minute Walk Test (MWT) distance from baseline||1.41|-11.97|0.1945
72396989|NCT02927080|144299962|SUPERIORITY||Mean Difference (Final Values)|4.69|STANDARD_ERROR_OF_MEAN|4.968||0.3451|TWO_SIDED|90.0|-3.48|12.86|||ANCOVA|||D190 Percent change from baseline in time to complete a 10 meter walk/run||12.86|-3.48|0.3451
72396990|NCT02927080|144299962|SUPERIORITY||Mean Difference (Final Values)|0.45|STANDARD_ERROR_OF_MEAN|6.03||0.9402|TWO_SIDED|90.0|-9.47|10.37|||ANCOVA|||D190 Percent change from baseline in time to complete 4-stair climb (ascend)||10.37|-9.47|0.9402
72396991|NCT02927080|144299963|SUPERIORITY||Mean Difference (Final Values)|36.12|STANDARD_ERROR_OF_MEAN|14.18||0.0183|TWO_SIDED|90.0|11.78|60.46|||ANCOVA|||||60.46|11.78|0.0183
72396992|NCT02927080|144299964|SUPERIORITY||Mean Difference (Final Values)|2.89|STANDARD_ERROR_OF_MEAN|1.7||0.0895|TWO_SIDED|90.0|0.09|5.69|||ANCOVA|||||5.69|0.09|0.0895
72396993|NCT02927080|144299965|SUPERIORITY||Mean Difference (Final Values)|-1.98|STANDARD_ERROR_OF_MEAN|3.459||0.5661|TWO_SIDED|90.0|-7.67|3.7|||ANCOVA|||Change from baseline in FSHD-HI, patient-reported outcome (PRO) measures Part 2 (Randomized, Controlled Portion)- Total Score for TA group part 2; compared to Placebo||3.70|-7.67|0.5661
72396994|NCT02927080|144299965|SUPERIORITY||Mean Difference (Final Values)|-0.11|STANDARD_ERROR_OF_MEAN|3.618||0.976|TWO_SIDED|90.0|-6.06|5.84|||ANCOVA|||Change from baseline in FSHD-HI, patient-reported outcome (PRO) measures Part 2 (Randomized, Controlled Portion)- Total Score for BB group part 2; compared to Placebo||5.84|-6.06|0.9760
72396995|NCT02564042|144299975|OTHER||Proportion difference|54.7|||||TWO_SIDED|95.0|25.9|76.6|||||Difference between GSK2894512 1% BID and Vehicle BID has been presented|||76.6|25.9|
72396996|NCT02564042|144299975|OTHER||Proportion difference|51.0|||||TWO_SIDED|95.0|22.2|73.2|||||Difference between GSK2894512 1% QD and Vehicle QD has been presented|||73.2|22.2|
72396997|NCT02564042|144299975|OTHER||Proportion difference|35.6|||||TWO_SIDED|95.0|6.3|60.5|||||Difference between GSK2894512 0.5% BID and Vehicle BID has been presented|||60.5|6.3|
72396998|NCT02564042|144299975|OTHER||Proportion difference|30.7|||||TWO_SIDED|95.0|1.6|55.9|||||Difference between GSK2894512 0.5% QD and Vehicle QD has been presented|||55.9|1.6|
72396999|NCT02564042|144299976|OTHER||Proportion difference|2.9|||||TWO_SIDED|95.0|-21.0|26.6|||||Difference between GSK2894512 1% QD and Vehicle QD at Week 1 has been presented|||26.6|-21.0|
72397000|NCT02564042|144299976|OTHER||Proportion difference|6.3||||||95.0|-20.5|32.4|||||Difference between GSK2894512 1% BID and Vehicle BID at Week 2 has been presented|||32.4|-20.5|
72397001|NCT02564042|144299976|OTHER||Proportion difference|15.2|||||TWO_SIDED|95.0|-9.6|39.1|||||Difference between GSK2894512 1% QD and Vehicle QD at Week 2 has been presented|||39.1|-9.6|
72506061|NCT01103349|144543778|SUPERIORITY||Adjusted mean treatment differences|2.369|STANDARD_DEVIATION|1.567||0.0657||95.0|-0.713|5.452||α=0.025 one-sided|Mixed Models Analysis|MMRM with baseline, treatment, day, treatment by day interaction and baseline by day interaction as fixed effects and patient as a random effect.||H0: Mean FEV1 % predicted trough change from baseline (Montelukast 10 mg qd) ≤ Mean FEV1 % predicted trough change from baseline (placebo)||5.452|-0.713|0.0657
72506062|NCT01103349|144543778|SUPERIORITY||Adjusted mean treatment differences|1.501|STANDARD_DEVIATION|1.602||0.1748|TWO_SIDED|95.0|-1.652|4.653||α=0.025 one-sided|Mixed Models Analysis|MMRM with baseline, treatment, day, treatment by day interaction and baseline by day interaction as fixed effects and patient as a random effect.||H0: Mean FEV1 % predicted trough change from baseline (BI671800 ED 400 mg bid) ≤ Mean FEV1 % predicted trough change from baseline (Montelukast 10 mg qd)||4.653|-1.652|0.1748
72506063|NCT01103349|144543779|SUPERIORITY||Adjusted mean treatment differences|-0.28|STANDARD_DEVIATION|0.118||0.0092|TWO_SIDED|95.0|-0.512|-0.048||α=0.025 one-sided|Mixed Models Analysis|MMRM with baseline, treatment, day, treatment by day interaction and baseline by day interaction as fixed effects and patient as a random effect.||||-0.048|-0.512|0.0092
72397002|NCT02564042|144299976|OTHER||Proportion difference|3.3|||||TWO_SIDED|95.0|-23.6|29.9|||||Difference between GSK2894512 0.5% BID and Vehicle BID at Week 2 has been presented|||29.9|-23.6|
72397003|NCT02564042|144299976|OTHER||Proportion difference|3.1|||||TWO_SIDED|95.0|-22.2|28.1|||||Difference between GSK2894512 0.5% QD and Vehicle QD at Week 2 has been presented|||28.1|-22.2|
72397004|NCT02564042|144299976|OTHER||Proportion difference|27.6|||||TWO_SIDED|95.0|-0.5|52.4|||||Difference between GSK2894512 1% BID and Vehicle BID at Week 4 has been presented|||52.4|-0.5|
72397005|NCT02564042|144299976|OTHER||Proportion difference|25.8|||||TWO_SIDED|95.0|-0.4|49.3|||||Difference between GSK2894512 1% QD and Vehicle QD at Week 4 has been presented|||49.3|-0.4|
72397006|NCT02564042|144299976|OTHER||Proportion difference|9.2|||||TWO_SIDED|95.0|-18.4|35.7|||||Difference between GSK2894512 0.5% BID and Vehicle BID at Week 4 has been presented|||35.7|-18.4|
72397007|NCT02564042|144299976|OTHER||Proportion difference|6.3|||||TWO_SIDED|95.0|-19.7|31.7|||||Difference between GSK2894512 0.5% QD and Vehicle QD at Week 4 has been presented|||31.7|-19.7|
72397008|NCT02564042|144299976|OTHER||Proportion difference|45.0|||||TWO_SIDED|95.0|16.6|68.4|||||Difference between GSK2894512 1% BID and Vehicle BID at Week 8 has been presented|||68.4|16.6|
72397009|NCT02564042|144299976|OTHER||Proportion difference|37.0|||||TWO_SIDED|95.0|8.7|61.3|||||Difference between GSK2894512 1% QD and Vehicle QD at Week 8 has been presented|||61.3|8.7|
72397010|NCT02564042|144299976|OTHER||Proportion difference|32.0|||||TWO_SIDED|95.0|3.5|57.2|||||Difference between GSK2894512 0.5% BID and Vehicle BID at Week 8 has been presented|||57.2|3.5|
72397011|NCT02564042|144299976|OTHER||Proportion difference|34.4|||||TWO_SIDED|95.0|6.3|58.7|||||Difference between GSK2894512 0.5% QD and Vehicle QD at Week 8 has been presented|||58.7|6.3|
72397012|NCT02564042|144299976|OTHER||Proportion difference|49.4|||||TWO_SIDED|95.0|20.1|72.4|||||Difference between GSK2894512 1% BID and Vehicle BID at Week 12 has been presented|||72.4|20.1|
72397013|NCT02564042|144299976|OTHER||Proportion difference|51.0|||||TWO_SIDED|95.0|22.2|73.2|||||Difference between GSK2894512 1% QD and Vehicle QD at Week 12 has been presented|||73.2|22.2|
72397014|NCT02564042|144299976|OTHER||Proportion difference|30.4|||||TWO_SIDED|95.0|1.0|56.1|||||Difference between GSK2894512 0.5% BID and Vehicle BID at Week 12 has been presented|||56.1|1.0|
72397015|NCT02564042|144299976|OTHER||Proportion difference|41.4|||||TWO_SIDED|95.0|12.7|65.0|||||Difference between GSK2894512 0.5% QD and Vehicle QD at Week 12 has been presented|||65.0|12.7|
72397016|NCT02564042|144299976|OTHER||Proportion difference|49.4|||||TWO_SIDED|95.0|20.1|72.4|||||Difference between GSK2894512 1% BID and Vehicle BID at Week 14 has been presented|||72.4|20.1|
72397017|NCT02564042|144299976|OTHER||Proportion difference|60.1|||||TWO_SIDED|95.0|33.2|80.1|||||Difference between GSK2894512 1% QD and Vehicle QD at Week 14 has been presented|||80.1|33.2|
72397018|NCT02564042|144299976|OTHER||Proportion difference|30.0|||||TWO_SIDED|95.0|0.2|56.5|||||Difference between GSK2894512 0.5% BID and Vehicle BID at Week 14 has been presented|||56.5|0.2|
72397019|NCT02564042|144299976|OTHER||Proportion difference|42.9|||||TWO_SIDED|95.0|14.4|66.5|||||Difference between GSK2894512 0.5% QD and Vehicle QD at Week 14 has been presented|||66.5|14.4|
72397020|NCT02564042|144299976|OTHER||Proportion difference|52.0|||||TWO_SIDED|95.0|23.2|74.4|||||Difference between GSK2894512 1% BID and Vehicle BID at Week 16 has been presented|||74.4|23.2|
72397021|NCT02564042|144299976|OTHER||Proportion difference|52.4|||||TWO_SIDED|95.0|24.4|74.0|||||Difference between GSK2894512 1% QD and Vehicle QD at Week 16 has been presented|||74.0|24.4|
72397022|NCT02564042|144299976|OTHER||Proportion difference|35.6|||||TWO_SIDED|95.0|6.3|60.5|||||Difference between GSK2894512 0.5% BID and Vehicle BID at Week 16 has been presented|||60.5|6.3|
72397023|NCT02564042|144299976|OTHER||Proportion difference|48.3|||||TWO_SIDED|95.0|19.7|71.1|||||Difference between GSK2894512 0.5% QD and Vehicle QD at Week 16 has been presented|||71.1|19.7|
72397024|NCT02564042|144299976|OTHER||Proportion difference|10.0|||||TWO_SIDED|95.0|-36.9|53.9|||||Difference between GSK2894512 1% BID and Vehicle BID at EW has been presented|||53.9|-36.9|
72397025|NCT02564042|144299976|OTHER||Proportion difference|42.9|||||TWO_SIDED|95.0|-6.3|81.6|||||Difference between GSK2894512 1% QD and Vehicle QD at EW has been presented|||81.6|-6.3|
72397026|NCT02564042|144299985|OTHER||Proportion difference|-3.6|||||TWO_SIDED|95.0|-28.8|21.9|||||Difference between GSK2894512 1% BID and Vehicle BID at Week 1 has been presented|||21.9|-28.8|
72397027|NCT02564042|144299985|OTHER||Proportion difference|-0.3|||||TWO_SIDED|95.0|-25.4|25.1|||||Difference between GSK2894512 0.5% BID and Vehicle BID at Week 1 has been presented|||25.1|-25.4|
72397028|NCT02564042|144299985|OTHER||Proportion difference|9.4|||||TWO_SIDED|95.0|-17.5|35.3|||||Difference between GSK2894512 1% BID and Vehicle BID at Week 2 has been presented|||35.3|-17.5|
72397029|NCT02564042|144299985|OTHER||Proportion difference|9.1|||||TWO_SIDED|95.0|-15.4|33.3|||||Difference between GSK2894512 1% QD and Vehicle QD at Week 2 has been presented .|||33.3|-15.4|
72622931|NCT03926247|144776090|OTHER|Within-group longitudinal analysis (no comparison groups)|Mean Difference (Final Values)|-0.892|STANDARD_ERROR_OF_MEAN|0.643|=|0.168|TWO_SIDED|95.0|-2.161|0.372|||Mixed Models Analysis|||Analyses were conducted using a mixed effects linear model to calculate least square means across the 4 timepoints. This was a longitudinal within-group analysis with 4 timepoints of data nested within 56 individuals. Our hypothesis was that participants' PTSD symptoms would decrease overtime.||0.372|-2.161|=0.168
72397030|NCT02564042|144299985|OTHER||Proportion difference|10.0|||||TWO_SIDED|95.0|-17.1|36.1|||||Difference between GSK2894512 0.5% BID and Vehicle BID at Week 2 has been presented .|||36.1|-17.1|
72397031|NCT02564042|144299985|OTHER||Proportion difference|6.3|||||TWO_SIDED|95.0|-19.3|31.0|||||Difference between GSK2894512 0.5% QD and Vehicle QD at Week 2 has been presented|||31.0|-19.3|
72397032|NCT02564042|144299985|OTHER||Proportion difference|9.7|||||TWO_SIDED|95.0|-18.2|36.7|||||Difference between GSK2894512 1% BID and Vehicle BID at Week 4 has been presented|||36.7|-18.2|
72397033|NCT02564042|144299985|OTHER||Proportion difference|19.4|||||TWO_SIDED|95.0|-6.9|43.6|||||Difference between GSK2894512 1% QD and Vehicle QD at Week 4 has been presented .|||43.6|-6.9|
72397034|NCT02564042|144299985|OTHER||Proportion difference|12.7|||||TWO_SIDED|95.0|-15.1|38.9|||||Difference between GSK2894512 0.5% BID and Vehicle BID at Week 4 has been presented|||38.9|-15.1|
72397035|NCT02564042|144299985|OTHER||Proportion difference|12.5|||||TWO_SIDED|95.0|-13.6|37.4|||||Difference between GSK2894512 0.5% QD and Vehicle QD at Week 4 has been presented .|||37.4|-13.6|
72397036|NCT02564042|144299985|OTHER||Proportion difference|42.3|||||TWO_SIDED|95.0|13.8|66.0|||||Difference between GSK2894512 1% BID and Vehicle BID at Week 8 has been presented|||66.0|13.8|
72397037|NCT02564042|144299985|OTHER||Proportion difference|37.0|||||TWO_SIDED|95.0|8.7|61.3|||||Difference between GSK2894512 1% QD and Vehicle QD at Week 8 has been presented|||61.3|8.7|
72397038|NCT02564042|144299985|OTHER||Proportion difference|33.3|||||TWO_SIDED|95.0|4.8|58.2|||||Difference between GSK2894512 0.5% BID and Vehicle BID at Week 8 has been presented .|||58.2|4.8|
72397039|NCT02564042|144299985|OTHER||Proportion difference|40.6|||||TWO_SIDED|95.0|12.8|63.9|||||Difference between GSK2894512 0.5% QD and Vehicle QD at Week 8 has been presented.|||63.9|12.8|
72397040|NCT02564042|144299985|OTHER||Proportion difference|54.7|||||TWO_SIDED|95.0|25.9|76.6|||||Difference between GSK2894512 1% BID and Vehicle BID at Week 12 has been presented.|||76.6|25.9|
72397041|NCT02564042|144299985|OTHER||Proportion difference|51.0|||||TWO_SIDED|95.0|22.2|73.2|||||Difference between GSK2894512 1% QD and Vehicle QD at Week 12 has been presented|||73.2|22.2|
72397042|NCT02564042|144299985|OTHER||Proportion difference|35.6|||||TWO_SIDED|95.0|6.3|60.5|||||Difference between GSK2894512 0.5% BID and Vehicle BID at Week 12 has been presented|||60.5|6.3|
72397043|NCT02564042|144299985|OTHER||Proportion difference|30.7|||||TWO_SIDED|95.0|1.6|55.9|||||Difference between GSK2894512 0.5% QD and Vehicle QD at Week 12 has been presented|||55.9|1.6|
72397044|NCT02564042|144299985|OTHER||Proportion difference|51.3|||||TWO_SIDED|95.0|22.0|74.0|||||Difference between GSK2894512 1% BID and Vehicle BID at Week 14 has been presented|||74.0|22.0|
72397045|NCT02564042|144299985|OTHER||Proportion difference|61.5|||||TWO_SIDED|95.0|34.6|81.0|||||Difference between GSK2894512 1% QD and Vehicle QD at Week 14 has been presented|||81.0|34.6|
72397046|NCT02564042|144299985|OTHER||Proportion difference|23.9|||||TWO_SIDED|95.0|-6.1|51.0|||||Difference between GSK2894512 0.5% BID and Vehicle BID at Week 14 has been presented|||51.0|-6.1|
72397047|NCT02564042|144299985|OTHER||Proportion difference|37.0|||||TWO_SIDED|95.0|7.8|61.6|||||Difference between GSK2894512 0.5% QD and Vehicle QD at Week 14 has been presented|||61.6|7.8|
72397048|NCT02564042|144299985|OTHER||Proportion difference|53.1|||||TWO_SIDED|95.0|24.7|75.6|||||Difference between GSK2894512 1% BID and Vehicle BID at Week 16 has been presented|||75.6|24.7|
72397049|NCT02564042|144299985|OTHER||Proportion difference|53.8|||||TWO_SIDED|95.0|25.8|75.5|||||Difference between GSK2894512 1% QD and Vehicle QD at Week 16 has been presented|||75.5|25.8|
72397050|NCT02564042|144299985|OTHER||Proportion difference|29.4|||||TWO_SIDED|95.0|-0.3|55.0|||||Difference between GSK2894512 0.5% BID and Vehicle BID at Week 16 has been presented|||55.0|-0.3|
72397051|NCT02564042|144299985|OTHER||Proportion difference|35.7|||||TWO_SIDED|95.0|6.5|60.2|||||Difference between GSK2894512 0.5% QD and Vehicle QD at Week 16 has been presented|||60.2|6.5|
72397052|NCT02564042|144299985|OTHER||Proportion difference|10.0|||||TWO_SIDED|95.0|-36.9|53.9|||||Difference between GSK2894512 1% BID and Vehicle BID at EW has been presented|||53.9|-36.9|
72397053|NCT02564042|144299985|OTHER||Proportion difference|42.9|||||TWO_SIDED|95.0|-6.3|81.6|||||Difference between GSK2894512 1% QD and Vehicle QD at EW has been presented|||81.6|-6.3|
72397054|NCT02564042|144299985|OTHER||Proportion difference|25.0|||||TWO_SIDED|95.0|-35.7|80.6|||||Difference between GSK2894512 0.5% BID and Vehicle BID at EW has been presented|||80.6|-35.7|
72397055|NCT00303498|144300035|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Net)|43.0||||0.0302|||||||ANCOVA|Change at Week 24: P-value was obtained from the non-parametric analysis of covariance (ANCOVA) controlling for baseline treadmill exercise time.||The median of the treatment difference was calculated using the Hodges-Lehmann estimator.||||0.0302
72397056|NCT00303498|144300036|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.5||||0.495|||||||ANCOVA|Change at Week 24: P-value was calculated from an ANCOVA with effect for treatment and baseline value as a covariate.||||||0.4950
72397057|NCT00303498|144300037|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|10.6||||0.3874|||||||ANCOVA|P-value was calculated from an ANCOVA with effect for treatment and baseline value as a covariate.||Change at Week 24 for PLAX 2D mode||||0.3874
72397058|NCT00303498|144300037|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.8||||0.7038|||||||ANCOVA|P-value was calculated from an ANCOVA with effect for treatment and baseline value as a covariate.||Change at Week 24 for PSAX M-mode||||0.7038
72397059|NCT00303498|144300038|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-1.9||||0.8998|||||||ANCOVA|P-value was calculated from an ANCOVA with effect for treatment and baseline value as a covariate.||||||0.8998
72397060|NCT00303498|144300039|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-1.7||||0.7245|||||||ANCOVA|P-value was calculated from an ANCOVA with effect for treatment and baseline value as a covariate.||||||0.7245
72397061|NCT00303498|144300040|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.5||||0.8649|||||||ANCOVA|P-value was calculated from an ANCOVA with effect for treatment and baseline value as a covariate.||||||0.8649
72397062|NCT00303498|144300041|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5909||||||The statistical analysis (P value) was performed on the composite change for all categories.|Cochran-Mantel-Haenszel|||Change at Week 24||||0.5909
72397063|NCT01493570|144300042|OTHER||Ratio CSF to Plasma in %|28.31||||1|TWO_SIDED|90.0|25.418|31.532||p-value for ratio outside interval 80% - 125%|ANOVA||Intra Individual geometric coefficient of variation (gCV \[%\]) = 17.50 .|Dose-adjusted CSF to plasma ratio for Cmax. The Analysis of Variance (ANOVA) model was used with 'subject nested within treatment' considered as random effect.||31.532|25.418|1.0000
72397064|NCT02598076|144300057|SUPERIORITY|||||||0.015|||||||t-test, 2 sided|||||||0.015
72397065|NCT02598076|144300058|SUPERIORITY|||||||0.034|||||||t-test, 2 sided|||||||0.034
72506064|NCT01103349|144543779|SUPERIORITY||Adjusted mean treatment differences|-0.18|STANDARD_DEVIATION|0.124||0.0732|TWO_SIDED|95.0|-0.423|0.063||α=0.025 one-sided|Mixed Models Analysis|MMRM with baseline, treatment, day, treatment by day interaction and baseline by day interaction as fixed effects and patient as a random effect.||||0.063|-0.423|0.0732
72506065|NCT01103349|144543779|SUPERIORITY||Adjusted mean treatment differences|-0.1|STANDARD_DEVIATION|0.126||0.2139|TWO_SIDED|95.0|-0.347|0.147||α=0.025 one-sided|Mixed Models Analysis|MMRM with baseline, treatment, day, treatment by day interaction and baseline by day interaction as fixed effects and patient as a random effect.||||0.147|-0.347|0.2139
72397066|NCT02598076|144300059|SUPERIORITY|||||||0.23|||||||t-test, 2 sided|||||||0.23
72397067|NCT02598076|144300060|SUPERIORITY|||||||0.095|||||||Fisher Exact|||||||0.095
72397068|NCT02598076|144300061|SUPERIORITY|||||||0.047|||||||t-test, 2 sided|||||||0.047
72397069|NCT05081011|144300067|OTHER|||||||0.006||||||A p-value of 0.05 would be considered statistically significant|Log Rank|||||||0.006
72397070|NCT05081011|144300068|OTHER||Mean Difference (Final Values)|32.7||||0.01|TWO_SIDED|95.0|8.0|57.4||A p-value of 0.05 would be considered statistically significant.|Welch 2-sample method|||||57.4|8.0|0.01
72397071|NCT05081011|144300069|OTHER||Mean Difference (Final Values)|-3.6||||0.03|TWO_SIDED|95.0|-6.8|-0.4||A p-value of 0.05 would be considered statistically significant.|Welch 2-sample method|||||-0.4|-6.8|0.03
72397072|NCT05081011|144300070|OTHER||Mean Difference (Final Values)|1.4||||0.06|TWO_SIDED|95.0|-0.03|2.8|||Welch 2-sample method|||||2.8|-0.03|0.06
72397073|NCT05081011|144300071|OTHER||Mean Difference (Final Values)|1.0||||0.46|TWO_SIDED|95.0|-1.6|3.5|||Welch 2-sample method|||||3.5|-1.6|0.46
72397074|NCT05081011|144300072|OTHER||Mean Difference (Final Values)|0.56||||0.005|TWO_SIDED|95.0|0.21|0.91|||2-sample test|2-sample test for equality of proportions with Yates continuity correction|Comparison of percentage (proportion) of participants achieving glycemic control.|Comparison of percentage (proportion) of participants achieving glycemic control.||0.91|0.21|0.005
72397075|NCT05081011|144300073|OTHER||Mean Difference (Final Values)|-68.9||||0.001|TWO_SIDED|95.0|-107.1|-30.1|||Welch 2-sample method|||||-30.1|-107.1|0.001
72397076|NCT01896531|144300091|SUPERIORITY|Unstratified analysis|Hazard Ratio (HR)|1.12|||=|0.56|TWO_SIDED|90.0|0.81|1.55|||Log Rank|||All randomized participants||1.55|0.81|= 0.56
72397077|NCT01896531|144300091|SUPERIORITY|Unstratified analysis|Hazard Ratio (HR)|1.07|||=|0.86|TWO_SIDED|90.0|0.54|2.11|||Log Rank|||Participants with PTEN loss tumors||2.11|0.54|= 0.86
72397078|NCT01896531|144300092|SUPERIORITY|Unstratified analysis|Hazard Ratio (HR)|1.52|||=|0.0234|TWO_SIDED|90.0|1.12|2.07|||Log Rank|||All randomized participants||2.07|1.12|= 0.0234
72397079|NCT01896531|144300092|SUPERIORITY|Unstratified analysis|Hazard Ratio (HR)|1.66|||=|0.2867|TWO_SIDED|90.0|0.75|3.65|||Log Rank|||Participants with PTEN loss tumors||3.65|0.75|= 0.2867
72397080|NCT01896531|144300092|SUPERIORITY|Unstratified analysis|Hazard Ratio (HR)|1.66|||=|0.1369|TWO_SIDED|90.0|0.94|2.93|||Log Rank|||Participants who are Akt Dx+||2.93|0.94|= 0.1369
72397081|NCT01896531|144300093|SUPERIORITY||Difference in Response Rates|-5.2|||=|0.5202|TWO_SIDED|90.0|-18.46|8.06|||Cochran-Mantel-Haenszel|||All randomized participants||8.06|-18.46|= 0.5202
72397082|NCT01896531|144300093|SUPERIORITY||Difference in Response Rates|-23.33|||=|0.2035|TWO_SIDED|90.0|-52.24|5.58|||Cochran-Mantel-Haenszel|||Participants with PTEN loss tumors||5.58|-52.24|= 0.2035
72397083|NCT01896531|144300093|SUPERIORITY||Difference in Response Rates|-4.35|||=|0.7697|TWO_SIDED|90.0|-28.48|19.79|||Cochran-Mantel-Haenszel|||Participants who are Akt Dx+||19.79|-28.48|= 0.7697
72397084|NCT01896531|144300094|SUPERIORITY|Unstratified analysis|Hazard Ratio (HR)|1.14|||=|0.5974|TWO_SIDED|90.0|0.76|1.73|||Log Rank|||All randomized participants||1.73|0.76|= 0.5974
72397085|NCT01896531|144300094|SUPERIORITY|Unstratified analysis|Hazard Ratio (HR)|0.71|||=|0.5385|TWO_SIDED|90.0|0.28|1.79|||Log Rank|||Participants with PTEN loss tumors||1.79|0.28|= 0.5385
72397086|NCT01896531|144300094|SUPERIORITY|Unstratified analysis|Hazard Ratio (HR)|0.78|||=|0.6097|TWO_SIDED|90.0|0.35|1.75|||Log Rank|||Participants who are Akt Dx+||1.75|0.35|= 0.6097
72397087|NCT00770289|144300100|SUPERIORITY_OR_OTHER||Pearson's correlation coefficient|0.899|||<|0.0001|TWO_SIDED|95.0|0.886|0.911||The statistical testing was done at alpha = 0.05.|Pearson's correlation|||Change from baseline at Week 12: Pearson's correlation coefficient was used to evaluate compatibility between the questionnaires.||0.911|0.886|<0.0001
72397088|NCT00770289|144300100|SUPERIORITY_OR_OTHER||Pearson's correlation coefficient|0.797|||<|0.0001|TWO_SIDED|95.0|0.771|0.82||The statistical testing was done at alpha = 0.05.|Pearson's correlation|||Change from baseline at Week 12: Pearson's correlation coefficient was used to evaluate compatibility between the questionnaires.||0.820|0.771|<0.0001
72397089|NCT00770289|144300100|SUPERIORITY_OR_OTHER||Pearson's correlation coefficient|0.765|||<|0.0001|TWO_SIDED|95.0|0.736|0.791||The statistical testing was done at alpha = 0.05.|Pearson's correlation|||Change from baseline at Week 12: Pearson's correlation coefficient was used to evaluate compatibility between the questionnaires.||0.791|0.736|<0.0001
72397090|NCT02956486|144300102|SUPERIORITY||Least Square (LS) Mean Difference|-0.17||||0.385|TWO_SIDED|95.0|-0.57|0.22|||MMRM|||Analysis was based on the MMRM and factors for treatment group, visit, treatment group by visit interaction, clinical disease staging (mild cognitive impairment \[MCI\]/Prodromal, mild alzheimer's disease \[AD\]), concurrent AD medication use, region, apolipoprotein E (ApoE4) status (positive, negative) as fixed effects, and the baseline value and the baseline value by visit interaction as covariate.||0.22|-0.57|0.385
72397091|NCT02956486|144300104|SUPERIORITY||LS Mean Difference|-0.02||||0.345|TWO_SIDED|95.0|-0.06|0.02|||MMRM|||Analysis was based on the MMRM and factors for treatment group, visit, treatment group by visit interaction, clinical disease staging (MCI/Prodromal, mild AD), concurrent AD medication use, region, ApoE4 status (positive, negative) as fixed effects, and the baseline value and the baseline value by visit interaction as covariate.||0.02|-0.06|0.345
72397092|NCT02956486|144300105|SUPERIORITY||LS Mean Difference|-12.83|||<|0.001|TWO_SIDED|95.0|-18.79|-6.88|||MMRM|||Analysis was based on the MMRM and factors for treatment group, visit, treatment group by visit interaction, clinical disease staging (MCI/Prodromal, mild AD), concurrent AD medication use, region, ApoE4 status (positive, negative) as fixed effects, and the baseline value and the baseline value by visit interaction as covariate.||-6.88|-18.79|<.001
72397093|NCT02956486|144300106|SUPERIORITY||LS Mean Difference|-0.23||||0.316|TWO_SIDED|95.0|-0.67|0.22|||MMRM|||Analysis was based on the MMRM and factors for treatment group, visit, treatment group by visit interaction, clinical disease staging (MCI/Prodromal, mild AD), concurrent AD medication use, region, ApoE4 status (positive, negative) as fixed effects, and the baseline value and the baseline value by visit interaction as covariate.||0.22|-0.67|0.316
72397094|NCT02956486|144300107|SUPERIORITY||LS Mean Difference|-0.03||||0.254|TWO_SIDED|95.0|-0.07|0.02|||MMRM|||Analysis was based on the MMRM and factors for treatment group, visit, treatment group by visit interaction, clinical disease staging (MCI/Prodromal, mild AD), concurrent AD medication use, region, ApoE4 status (positive, negative) as fixed effects, and the baseline value and the baseline value by visit interaction as covariate.||0.02|-0.07|0.254
72397095|NCT02956486|144300108|SUPERIORITY||Difference of Mean Slope|-0.008||||0.9088|TWO_SIDED|95.0|-0.145|0.129|||Linear mixed effects model|||Based on the linear mixed effects model, which included assessment time and treatment group by assessment time interaction as covariate with random intercept and slope.||0.129|-0.145|0.9088
72397096|NCT02956486|144300109|SUPERIORITY||Hazard Ratio (HR)|0.95||||0.6155|TWO_SIDED|95.0|0.77|1.16|||Regression, Cox|||Based on a Cox regression model which included treatment group, clinical disease staging (MCI/Prodromal, mild AD), concurrent AD medication use, region, APOE4 status (positive, negative) as covariate.||1.16|0.77|0.6155
72397097|NCT02956486|144300110|SUPERIORITY||Hazard Ratio (HR)|1.14||||0.1281|TWO_SIDED|95.0|0.96|1.35|||Regression, Cox|||Based on a Cox regression model which included treatment group, concurrent AD medication use, region, APOE4 status (positive, negative) as covariate.||1.35|0.96|0.1281
72506066|NCT00090285|144543780|SUPERIORITY_OR_OTHER||Risk Difference (RD)|90.6||||||95.0|70.1|98.2|||||Confidence Interval (CI) based on binomial tail probabilities and not from a dispersion parameter.|||98.2|70.1|
72506067|NCT00090285|144543788|SUPERIORITY_OR_OTHER||Risk Difference (RD)|77.5||||||95.0|39.6|93.3||||||||93.3|39.6|
72506068|NCT00090285|144543789|SUPERIORITY_OR_OTHER||Risk Difference (RD)|85.5||||||95.0|77.0|91.3|||||CI based on binomial tail probabilities and not from a dispersion parameter. Hochberg multiplicity adjustment applied to the CI.|||91.3|77.0|
72506069|NCT00090285|144543790|SUPERIORITY_OR_OTHER||Risk Difference (RD)|51.0||||||95.0|40.3|59.9|||||CI based on binomial tail probabilities and not from a dispersion parameter. Hochberg multiplicity adjustment applied to the CI.|||59.9|40.3|
72506070|NCT02639182|144543809|SUPERIORITY|The difference between treatment groups was tested using a stratified log rank test at a one-sided 0.1 significance level.||||||0.983||||||The stratification factors were the ECOG PS at baseline and the number of prior systemic renal cell carcinoma (RCC) regimens, without any other covariate(s). The model contained terms for treatment group and stratum.|Log Rank|||||||0.983
72397098|NCT02956486|144300111|SUPERIORITY||LS Mean Difference|-0.43||||0.525|TWO_SIDED|95.0|-1.75|0.9|||MMRM|||Analysis was based on the MMRM and factors for treatment group, visit, treatment group by visit interaction, clinical disease staging (MCI/Prodromal, mild AD), concurrent AD medication use, region, ApoE4 status (positive, negative) as fixed effects, and the baseline value and the baseline value by visit interaction as covariate.||0.90|-1.75|0.525
72397099|NCT02956486|144300112|SUPERIORITY||LS Mean Difference|-0.01||||0.977|TWO_SIDED|95.0|-0.64|0.62|||MMRM|||Analysis was based on the MMRM and factors for treatment group, visit, treatment group by visit interaction, clinical disease staging (MCI/Prodromal, mild AD), concurrent AD medication use, region, ApoE4 status (positive, negative) as fixed effects, and the baseline value and the baseline value by visit interaction as covariate.||0.62|-0.64|0.977
72397100|NCT02956486|144300113|SUPERIORITY||LS Mean Difference|0.11||||0.854|TWO_SIDED|95.0|-1.09|1.32|||MMRM|||Analysis was based on the MMRM and factors for treatment group, visit, treatment group by visit interaction, clinical disease staging (MCI/Prodromal, mild AD), concurrent AD medication use, region, ApoE4 status (positive, negative) as fixed effects, and the baseline value and the baseline value by visit interaction as covariate.||1.32|-1.09|0.854
72397101|NCT02956486|144300114|SUPERIORITY||LS Mean Difference|-0.27||||0.314|TWO_SIDED|95.0|-0.79|0.26|||MMRM|||Analysis was based on the MMRM and factors for treatment group, visit, treatment group by visit interaction, clinical disease staging (MCI/Prodromal, mild AD), concurrent AD medication use, region, ApoE4 status (positive, negative) as fixed effects, and the baseline value and the baseline value by visit interaction as covariate.||0.26|-0.79|0.314
72397102|NCT02956486|144300115|SUPERIORITY||LS Mean Difference|0.07||||0.895|TWO_SIDED|95.0|-0.93|1.07|||MMRM|||Analysis was based on the MMRM and factors for treatment group, visit, treatment group by visit interaction, clinical disease staging (MCI/Prodromal, mild AD), concurrent AD medication use, region, ApoE4 status (positive, negative) as fixed effects, and the baseline value and the baseline value by visit interaction as covariate.||1.07|-0.93|0.895
72397103|NCT02956486|144300116|SUPERIORITY||LS Mean Difference|0.04||||0.542|TWO_SIDED|95.0|-0.09|0.17|||MMRM|||Analysis was based on the MMRM and factors for treatment group, visit, treatment group by visit interaction, clinical disease staging (MCI/Prodromal, mild AD), concurrent AD medication use, region, ApoE4 status (positive, negative) as fixed effects, and the baseline value as covariate.||0.17|-0.09|0.542
72397104|NCT02956486|144300117|SUPERIORITY||LS Mean Difference|-0.01||||0.38|TWO_SIDED|95.0|-0.02|0.01|||MMRM|||Analysis was based on the MMRM and factors for treatment group, visit, treatment group by visit interaction, clinical disease staging (MCI/Prodromal, mild AD), concurrent AD medication use, region, ApoE4 status (positive, negative) as fixed effects, and the baseline value as covariate.||0.01|-0.02|0.380
72397105|NCT02956486|144300118|SUPERIORITY||LS Mean Difference|-0.4||||0.063|TWO_SIDED|95.0|-0.82|0.02|||MMRM|||Analysis was based on the MMRM and factors for treatment group, visit, treatment group by visit interaction, clinical disease staging (MCI/Prodromal, mild AD), concurrent AD medication use, region, ApoE4 status (positive, negative) as fixed effects, and the baseline value as covariate.||0.02|-0.82|0.063
72397106|NCT02956486|144300119|SUPERIORITY||LS Mean Difference|-0.56||||0.045|TWO_SIDED|95.0|-1.11|-0.01|||MMRM|||Analysis was based on the MMRM and factors for treatment group, visit, treatment group by visit interaction, clinical disease staging (MCI/Prodromal, mild AD), concurrent AD medication use, region, ApoE4 status (positive, negative) as fixed effects, and the baseline value as covariate.||-0.01|-1.11|0.045
72397107|NCT02956486|144300120|SUPERIORITY||LS Mean Difference|-0.04||||0.799|TWO_SIDED|95.0|-0.32|0.24|||MMRM|||Analysis was based on the MMRM and factors for treatment group, visit, treatment group by visit interaction, clinical disease staging (MCI/Prodromal, mild AD), concurrent AD medication use, region, ApoE4 status (positive, negative) as fixed effects, and the baseline value as covariate.||0.24|-0.32|0.799
72397108|NCT02956486|144300121|SUPERIORITY||LS Mean Difference|-0.32||||0.012|TWO_SIDED|95.0|-0.56|-0.07|||MMRM|||Analysis was based on the MMRM and factors for treatment group, visit, treatment group by visit interaction, clinical disease staging (MCI/Prodromal, mild AD), concurrent AD medication use, region, ApoE4 status (positive, negative) as fixed effects, and the baseline value as covariate.||-0.07|-0.56|0.012
72397109|NCT00345254|144300138|SUPERIORITY|||||||0.1|||||||t-test, 2 sided|||||||0.1
72397110|NCT00862745|144300150|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||No adjustment for multiple comparisons, threshold for significance is P \< .05|ANCOVA|Mean difference=Drug A minus Drug B||Null hypothesis: fesoterodine treatment is not associated with greater reduction in urgency incontinence frequency compared to placebo in women diagnosed using the 3IQ||||<0.001
72397111|NCT00667368|144300161|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|-0.9||||0.754|TWO_SIDED|95.0|-12.0|10.1|||Two-sample test, Poisson||The risk difference reflects the treatment arm minus the control arm. The units are the number of positive tests for chlamydia and gonorrhea per 100 person-years.|||10.1|-12.0|0.754
72397112|NCT00667368|144300162|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Fisher Exact|||||||<0.001
72397113|NCT00732615|144300167|SUPERIORITY_OR_OTHER_LEGACY||Treatment difference|52.3|||<|0.001|TWO_SIDED|95.0|40.6|64.0||A fixed sequence test procedure was used to control the study level type I error. Order of test sequence started with the primary efficacy endpoint and proceeded to the 3 secondary efficacy endpoints, in the order defined in the protocol.|Fisher Exact|The 2-sided Fisher's Exact test was utilized to test for difference between NPSP558 and the placebo treatment groups.|The above two sided asymptotic 95% confidence interval is based on normal approximation.|The null hypothesis is that the % of subjects meeting primary efficacy endpoint criteria are the same for both tmt arms. The sample size was determined based on the assumption that 40% and 10% of subjects for NPSP558 and pbo arms would meet the endpt criteria, respectively. Based on 2-tailed test, alpha of 0.05 and 2-to-1 randomization ratio, 84 (56 NPSP558, 28 pbo) subjects who completing the study would achieve 80% statistical power. Adjusted for dropouts, planned enrollment was 110 subjects.||64.0|40.6|<0.001
72397114|NCT00732615|144300168|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||Following fixed sequence test procedure described in the primary endpoint section, statistical hypothesis testing was conducted for this secondary endpoint after the testing for the primary endpoint reached statistical significance.|ANCOVA|ANCOVA analysis conducted using percentage change from baseline as dependent variable, treatment as factor, and baseline calcium dose as covariate.||The null hypothesis is that there is no difference between the percentage changes from baseline for the two treatment arms.||||<0.001
72565729|NCT02709486|144662693|SUPERIORITY||Odds Ratio (OR)|1.73||||0.0018|TWO_SIDED|95.0|1.23|2.45|||Regression, Logistic|||Week 24, \>=50%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.45|1.23|0.0018
72397115|NCT00732615|144300169|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|11.711|||<|0.001|TWO_SIDED|95.0|2.619|52.363||Following fixed sequence test procedure described in the primary endpoint section, statistical hypothesis testing was conducted for this secondary endpoint after the testing for the first secondary endpoint reached statistical significance.|Cochran-Mantel-Haenszel|||The null hypothesis is that there is no difference between the proportions of subjects (who achieved this secondary endpoint) from the two treatment arms.||52.363|2.619|<0.001
72397116|NCT00732615|144300170|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.879||||0.747|TWO_SIDED|95.0|0.402|1.922||Following fixed sequence test procedure described in the primary endpoint section, statistical hypothesis testing was conducted for this secondary endpoint after the testing for the second secondary endpoint reached statistical significance.|Cochran-Mantel-Haenszel|||The null hypothesis is that the percentages of subjects with any reported clinical symptoms for the two treatment arms are the same.||1.922|0.402|0.747
72397117|NCT00748033|144300203|OTHER|||||||0.065|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon signed rank test, two-sided. Testing the hypothesis that the perception is same.||||0.0650
72397118|NCT00748033|144300204|OTHER|||||||0.2487|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon signed rank test, two-sided. Testing the hypothesis that the perception is same.||||0.2487
72397119|NCT00748033|144300205|OTHER|||||||0.7288|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon signed rank test, two-sided. Testing the hypothesis that the perception is same.||||0.7288
72397120|NCT00748033|144300206|OTHER|||||||0.0045|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon signed rank test, two-sided. Testing the hypothesis that the perception is same.||||0.0045
72397121|NCT00748033|144300207|OTHER|||||||0.4561|||||||Wilcoxon (Mann-Whitney)|Wilcoxon signed rank test if the difference between 5s and 24h is equal to 0.||Testing the hypothesis that 5s and 24 h are equal at insertion.||||0.4561
72397122|NCT00748033|144300208|OTHER|||||||0.1797|||||||Wilcoxon (Mann-Whitney)|Wilcoxon signed rank test if the difference between 5s and 24h is equal to 0.||Testing the hypothesis that 5s and 24 h are equal at withdrawal.||||0.1797
72397123|NCT00748033|144300209|OTHER|||||||0.5171|||||||Wilcoxon (Mann-Whitney)|Wilcoxon signed rank test if the difference between 5s and 24h is equal to 0.||The mean perception of the 5s and the 24h catheter is calculated for each patient. The patients are then divided in two groups depending on the order the patients received the two catheters and the hypotheses that the mean of the 5s and the 24h catheter is equal in the two groups are tested. If the test results in a significant p-value it can be concluded that a carry-over effect is present.||||0.5171
72397124|NCT00748033|144300210|OTHER|||||||0.7105|||||||Wilcoxon (Mann-Whitney)|||The mean perception of the 5s and the 24h catheter is calculated for each patient. The patients are then divided in two groups depending on the order the patients received the two catheters and the hypotheses that the mean of the 5s and the 24h catheter is equal in the two groups are tested. If the test results in a significant p-value it can be concluded that a carry-over effect is present.||||0.7105
72397125|NCT00748033|144300211|OTHER|||||||0.0003|||||||Wilcoxon (Mann-Whitney)|||||||0.0003
72397126|NCT00748033|144300212|OTHER|||||||0.0346|||||||Wilcoxon (Mann-Whitney)|||||||0.0346
72471682|NCT00474526|144466778|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of US1A over US1B, the lower limit of 95% CI for the difference in rates (PUS1A - PUS1B) had to be greater than -10%.|Percentage difference|4.0|||||TWO_SIDED|95.0|-4.0|11.0|||ANOVA|||PnC 19F (percentage difference (US1A:US1B))||11|-4|
72565730|NCT02709486|144662693|SUPERIORITY||Odds Ratio (OR)|1.47||||0.097|TWO_SIDED|95.0|0.93|2.31|||Regression, Logistic|||Week 24, \>=70%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.31|0.93|0.0970
72397127|NCT00748033|144300213|OTHER|||||||0.0016|||||||Wilcoxon (Mann-Whitney)|||||||0.0016
72397128|NCT00556712|144300314|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.71|||<|0.0001|TWO_SIDED|95.0|0.62|0.82|||Log Rank|||||0.82|0.62|<0.0001
72471683|NCT00474526|144466778|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of US1A over US1B, the lower limit of 95% CI for the difference in rates (PUS1A - PUS1B) had to be greater than -10%.|Percentage difference|-2.0|||||TWO_SIDED|95.0|-10.0|5.0|||ANOVA|||PnC 239F (percentage difference (US1A:US1B))||5|-10|
72397129|NCT00556712|144300318|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.83||||0.0097|TWO_SIDED|95.0|0.72|0.96|||Log Rank|||||0.96|0.72|0.0097
72397130|NCT00556712|144300321|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.78||||0.005|TWO_SIDED|95.0|0.66|0.93|||Log Rank|||||0.93|0.66|0.0050
72397131|NCT00556712|144300324|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.77||||0.1768|TWO_SIDED|95.0|0.51|1.14|||Log Rank|||||1.14|0.51|0.1768
72397132|NCT00556712|144300327|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.83||||0.4797|TWO_SIDED|95.0|0.49|1.4|||Log Rank|||||1.40|0.49|0.4797
72397133|NCT00556712|144300329|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.7|||<|0.0001|TWO_SIDED|95.0|0.61|0.82|||Log Rank|||||0.82|0.61|<0.0001
72397134|NCT00556712|144300331|SUPERIORITY_OR_OTHER||Difference in Response Rates|6.53||||0.0006|TWO_SIDED|95.0|2.7|10.3|||Chi-squared||The approximate 95% CI for the difference of two rates was determined using the Hauck-Anderson method.|||10.3|2.7|0.0006
72397135|NCT00556712|144300333|SUPERIORITY_OR_OTHER||Difference in Response Upgrade Rates|4.2||||0.0007|TWO_SIDED|95.0|1.6|6.7|||Chi-squared||The approximate 95% CI for the difference of two rates was determined using the Hauck-Anderson method.|||6.7|1.6|0.0007
72397136|NCT00556712|144300335|SUPERIORITY_OR_OTHER||Difference in Disease Control Rates|9.8||||0.0035|TWO_SIDED|95.0|3.1|16.4|||Chi-squared||Approximate 95% CI for the difference of two rates was determined using the Hauck-Anderson method.|Analysis included CR + PR + SD rate.||16.4|3.1|0.0035
72397137|NCT00556712|144300335|SUPERIORITY_OR_OTHER||Difference in Disease Control Rates|13.4|||<|0.0001|TWO_SIDED|95.0|7.1|19.7|||Chi-squared||Approximate 95% CI for the difference of two rates was determined using the Hauck-Anderson method.|Analysis included CR + PR + SD \> 12 weeks rate.||19.7|7.1|<0.0001
72397138|NCT00556712|144300337|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.91||||0.3787|TWO_SIDED|95.0|0.74|1.12|||Log Rank|||||1.12|0.74|0.3787
72397139|NCT00556712|144300339|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.69|||<|0.0001|TWO_SIDED|95.0|0.58|0.82|||Log Rank|||||0.82|0.58|< 0.0001
72397140|NCT00556712|144300342|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.06||||0.5385|TWO_SIDED|95.0|0.87|1.31|||Log Rank|||||1.31|0.87|0.5385
72397141|NCT00556712|144300345|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.96||||0.653|TWO_SIDED|95.0|0.79|1.16|||Log Rank|||||1.16|0.79|0.6530
72397142|NCT02671422|144300353|OTHER||1 year-survival rate|0.342|||||TWO_SIDED|95.0|0.0|0.894|||||Confidence interval is computed based on the LOGLOG method.|||0.894|0.000|
72397143|NCT04702997|144300357|SUPERIORITY||LS Mean difference (Net)|7.71|STANDARD_ERROR_OF_MEAN|1.268|<|0.0001|TWO_SIDED|95.0|5.18|10.24||KDIGO strata, treatment group, time (Week 1 to 12), and the interaction between treatment and time were used as fixed factors.|Mixed Models Analysis||Difference is bardoxolone methyl - placebo|||10.24|5.18|<0.0001
72471684|NCT00474526|144466779|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA1A over LA1B, the lower limit of the two-sided 95% CI for the ratio of pneumococcal GMCs (GMCLA1A / GMCLA1B) had to be greater than 0.50.|Ratio of GMCs|0.79|||||TWO_SIDED|95.0|0.61|1.02|||ANOVA|||PnC 4 (Post-vaccination GMC; group ratio LA1A:LA1B)||1.02|0.61|
72397144|NCT00353262|144300510|SUPERIORITY_OR_OTHER||Geometric mean ratio|0.9|||||TWO_SIDED|90.0|0.79|1.02||||||Cycle 2, Day 1 versus Cycle 1, Day 1||1.02|0.79|
72397145|NCT00353262|144300510|SUPERIORITY_OR_OTHER||Geometric mean ratio|0.87|||||TWO_SIDED|90.0|0.76|0.99||||||Cycle 3, Day 1 versus Cycle 1, Day 1||0.99|0.76|
72397146|NCT00353262|144300510|SUPERIORITY_OR_OTHER||Geometric mean ratio|0.97|||||TWO_SIDED|90.0|0.85|1.1||||||Cycle 3, Day 1 to Cycle 2, Day 1||1.10|0.85|
72397147|NCT00353262|144300511|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.05|||||TWO_SIDED|90.0|1.01|1.08||||||Cycle 2, Day 1 versus Cycle 1, Day 2||1.08|1.01|
72397148|NCT00353262|144300511|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.02|||||TWO_SIDED|90.0|0.98|1.05||||||Cycle 3, Day 1 to Cycle 1, Day 2||1.05|0.98|
72397149|NCT00353262|144300511|SUPERIORITY_OR_OTHER||Geometric mean ratio|0.97|||||TWO_SIDED|90.0|0.94|1.0||||||Cycle 3, Day 1 to Cycle 2, Day 1||1.00|0.94|
72397150|NCT00353262|144300512|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.02|||||TWO_SIDED|90.0|0.83|1.24||||||Capecitabine: Cycle 2, Day 1 versus Cycle 1, Day 1||1.24|0.83|
72397151|NCT00353262|144300512|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.16|||||TWO_SIDED|90.0|0.94|1.42||||||Capecitabine: Cycle 3, Day 1 to Cycle 2, Day 1||1.42|0.94|
72397152|NCT00353262|144300512|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.17|||||TWO_SIDED|90.0|0.96|1.44||||||Capecitabine: Cycle 3, Day 1 to Cycle 1, Day 1||1.44|0.96|
72397153|NCT00353262|144300512|SUPERIORITY_OR_OTHER||Geometric mean ratio|0.86|||||TWO_SIDED|90.0|0.69|1.08||||||5'-DFCR: Cycle 2, Day 1 versus Cycle 1, Day 1||1.08|0.69|
72397154|NCT00353262|144300512|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.08|||||TWO_SIDED|90.0|0.86|1.34||||||5'-DFCR: Cycle 3, Day 1 versus Cycle 1, Day 1||1.34|0.86|
72397155|NCT00353262|144300512|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.25|||||TWO_SIDED|90.0|1.0|1.55||||||5'-DFCR: Cycle 3, Day 1 versus Cycle 2, Day 1||1.55|1.00|
72397156|NCT00353262|144300512|SUPERIORITY_OR_OTHER||Geometric mean ratio|0.81|||||TWO_SIDED|90.0|0.66|1.01||||||5-FU: Cycle 2, Day 1 versus Cycle 1, Day 1||1.01|0.66|
72397157|NCT00353262|144300512|SUPERIORITY_OR_OTHER||Geometric mean ratio|0.79|||||TWO_SIDED|90.0|0.64|0.97||||||5-FU: Cycle 3, Day 1 versus Cycle 1, Day 1||0.97|0.64|
72397158|NCT00353262|144300512|SUPERIORITY_OR_OTHER||Geometric mean ratio|0.97|||||TWO_SIDED|90.0|0.78|1.19||||||5-FU: Cycle 3, Day 1 versus Cycle 2, Day 1||1.19|0.78|
72397159|NCT00353262|144300512|SUPERIORITY_OR_OTHER||Geometric mean ratio|0.97|||||TWO_SIDED|90.0|0.91|1.04||||||FBAL: Cycle 2, Day 1 versus Cycle 1, Day 1||1.04|0.91|
72397160|NCT00353262|144300512|SUPERIORITY_OR_OTHER||Geometric mean ratio|0.97|||||TWO_SIDED|90.0|0.9|1.04||||||FBAL: Cycle 3, Day 1 versus Cycle 1, Day 1||1.04|0.90|
72397161|NCT00353262|144300512|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.0|||||TWO_SIDED|90.0|0.93|1.07||||||FBAL: Cycle 3, Day 1 versus Cycle 2, Day 1||1.07|0.93|
72397162|NCT00353262|144300514|SUPERIORITY_OR_OTHER||Geometric mean ratio|0.74|||||TWO_SIDED|90.0|0.61|0.9||||||5'-DFUR: Cycle 2, Day 1 versus Cycle 1, Day 1||0.90|0.61|
72397163|NCT00353262|144300514|SUPERIORITY_OR_OTHER||Geometric mean ratio|0.64|||||TWO_SIDED|90.0|0.53|0.79||||||5'-DFUR: Cycle 3, Day 1 versus Cycle 1, Day 1||0.79|0.53|
72397164|NCT00353262|144300514|SUPERIORITY_OR_OTHER||Geometric mean ratio|0.87|||||TWO_SIDED|90.0|0.71|1.06||||||5'-DFUR: Cycle 3, Day 1 versus Cycle 2, Day 1||1.06|0.71|
72397165|NCT00353262|144300514|SUPERIORITY_OR_OTHER||Geometric mean ratio|0.82|||||TWO_SIDED|90.0|0.63|1.08||||||Capecitabine: Cycle 2, Day 1 versus Cycle 1, Day 1||1.08|0.63|
72397166|NCT00353262|144300514|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.03|||||TWO_SIDED|90.0|0.78|1.34||||||Capecitabine: Cycle 3, Day 1 versus Cycle 2, Day 1||1.34|0.78|
72397167|NCT00353262|144300514|SUPERIORITY_OR_OTHER||Geometric mean ratio|0.85|||||TWO_SIDED|90.0|0.65|1.1||||||Capecitabine: Cycle 3, Day 1 versus Cycle 1, Day 1||1.10|0.65|
72397168|NCT00353262|144300514|SUPERIORITY_OR_OTHER||Geometric mean ratio|0.87|||||TWO_SIDED|90.0|0.65|1.18||||||5'-DFCR: Cycle 2, Day 1 versus Cycle 1, Day 1||1.18|0.65|
72397169|NCT00353262|144300514|SUPERIORITY_OR_OTHER||Geometric mean ratio|0.96|||||TWO_SIDED|90.0|0.71|1.3||||||5'-DFCR: Cycle 3, Day 1 versus Cycle 1, Day 1||1.30|0.71|
72397170|NCT00353262|144300514|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.1|||||TWO_SIDED|90.0|0.81|1.49||||||5'-DFCR: Cycle 3, Day 1 versus Cycle 2, Day 1||1.49|0.81|
72397171|NCT00353262|144300514|SUPERIORITY_OR_OTHER||Geometric mean ratio|0.74|||||TWO_SIDED|90.0|0.56|0.98||||||5-FU: Cycle 2, Day 1 versus Cycle 1, Day 1||0.98|0.56|
72397172|NCT00353262|144300514|SUPERIORITY_OR_OTHER||Geometric mean ratio|0.58|||||TWO_SIDED|90.0|0.44|0.76||||||5-FU: Cycle 3, Day 1 versus Cycle 1, Day 1||0.76|0.44|
72397173|NCT00353262|144300514|SUPERIORITY_OR_OTHER||Geometric mean ratio|0.78|||||TWO_SIDED|90.0|0.59|1.03||||||5-FU: Cycle 3, Day 1 versus Cycle 2, Day 1||1.03|0.59|
72397174|NCT00353262|144300514|SUPERIORITY_OR_OTHER||Geometric mean ratio|0.91|||||TWO_SIDED|90.0|0.83|1.0||||||FBAL: Cycle 2, Day 1 versus Cycle 1, Day 1||1.00|0.83|
72397175|NCT00353262|144300514|SUPERIORITY_OR_OTHER||Geometric mean ratio|0.83|||||TWO_SIDED|90.0|0.76|0.91||||||FBAL: Cycle 3, Day 1 versus Cycle 1, Day 1||0.91|0.76|
72397176|NCT00353262|144300514|SUPERIORITY_OR_OTHER||Geometric mean ratio|0.91|||||TWO_SIDED|90.0|0.83|1.0||||||FBAL: Cycle 3, Day 1 versus Cycle 2, Day 1||1.00|0.83|
72397177|NCT00353262|144300516|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.2|||||TWO_SIDED|90.0|1.09|1.33||||||Total Platinum: Cycle 2, Day 1 versus Cycle 1, Day 2||1.33|1.09|
72397178|NCT00353262|144300516|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.34|||||TWO_SIDED|90.0|1.21|1.48||||||Total Platinum: Cycle 3, Day 1 versus Cycle 1, Day 2||1.48|1.21|
72397179|NCT00353262|144300516|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.11|||||TWO_SIDED|90.0|1.01|1.23||||||Total Platinum: Cycle 3, Day 1 versus Cycle 2, Day 1||1.23|1.01|
72397180|NCT00353262|144300518|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.02|||||TWO_SIDED|90.0|0.96|1.09||||||Total Platinum: Cycle 2, Day 1 versus Cycle 1, Day 2||1.09|0.96|
72397181|NCT00353262|144300518|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.01|||||TWO_SIDED|90.0|0.95|1.08||||||Total Platinum: Cycle 3, Day 1 versus Cycle 1, Day 2||1.08|0.95|
72397182|NCT00353262|144300518|SUPERIORITY_OR_OTHER||Geometric mean ratio|0.99|||||TWO_SIDED|90.0|0.93|1.05||||||Total Platinum: Cycle 3, Day 1 versus Cycle 2, Day 1||1.05|0.93|
72397183|NCT00353262|144300518|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.01|||||TWO_SIDED|90.0|0.94|1.09||||||Free Platinum: Cycle 2, Day 1 versus Cycle 1, Day 2||1.09|0.94|
72397184|NCT00353262|144300518|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.0|||||TWO_SIDED|90.0|0.92|1.08||||||Free Platinum: Cycle 3, Day 1 versus Cycle 1, Day 2||1.08|0.92|
72397185|NCT00353262|144300518|SUPERIORITY_OR_OTHER||Geometric mean ratio|0.99|||||TWO_SIDED|90.0|0.91|1.07||||||Free Platinum: Cycle 3, Day 1 versus Cycle 2, Day 1||1.07|0.91|
72397186|NCT04615923|144300559|SUPERIORITY||Disease Rate Ratio|0.99|STANDARD_DEVIATION|0.103|||TWO_SIDED|95.0|0.801|1.207||Posterior probability that the disease rate ratio (DRR) is less than 1 (i.e. Pridopidine slowed progression) was (0.5475). NOTE: p-value is not provided for Bayesian model.|Bayesian shared-parameter model|A Bayesian shared-parameter model of change in disease severity as measured by ALSFRS-R total score and mortality.|"DDR \<1 imply slowing of disease progression by verdiperstat relative to placebo.Note: reported Confidence Interval is actually a Bayesian credible interval."||The DRR parameter for active treatment represents the relative change to the rate of decline of ALSFRS-R and the rate of mortality of treated participant relative to a placebo participant. The estimated DRR can also be interpreted as the average rate of decline in function and mortality. The model includes covariates for baseline use of edaravone, baseline use of riluzole, months since onset of symptoms, and pre-baseline slope of ALSFRS-R, and random effects for regimen and participant-specific slopes.|1.207|0.801|
72397187|NCT04615923|144300561|SUPERIORITY||Median Difference (Net)|-0.09|STANDARD_ERROR_OF_MEAN|0.334||0.78|TWO_SIDED|95.0|-0.75|0.57|||Mixed Models Analysis|Covariates include baseline use of edaravone and riluzole, months since symptom onset, and pre-baseline ALSFRS-R slope.|Pridopidine 24-week change from baseline relative to placebo 24-week change from baseline.|||0.57|-0.75|0.78
72397188|NCT04615923|144300562|SUPERIORITY||Median Difference (Net)|0.1|STANDARD_ERROR_OF_MEAN|0.217||0.6594|TWO_SIDED|95.0|-0.33|0.52|||Mixed Models Analysis|Covariates include baseline use of edaravone and riluzole, months since symptom onset, and pre-baseline ALSFRS-R slope.|Pridopidine 24-week change from baseline relative to placebo 24-week change from baseline.|||0.52|-0.33|0.6594
72397189|NCT04615923|144300563|SUPERIORITY||Mean Difference (Net)|-0.46|STANDARD_ERROR_OF_MEAN|1.745||0.7918|TWO_SIDED|95.0|-3.89|2.96|||Mixed Models Analysis|Covariates include baseline use of edaravone and riluzole, months since symptom onset, and pre-baseline ALSFRS-R slope.|Pridopidine 24-week change from baseline relative to placebo 24-week change from baseline.|||2.96|-3.89|0.7918
72622932|NCT03926247|144776091|OTHER|Within-group longitudinal analysis (no comparison groups)|Mean Difference (Final Values)|-0.061|STANDARD_ERROR_OF_MEAN|0.035|=|0.051|TWO_SIDED|95.0|-0.14|0.0|||Mixed Models Analysis|||Analyses were conducted using a mixed effects linear model to calculate least square means across the 4 timepoints. This was a longitudinal within-group analysis with 4 timepoints of data nested within 56 individuals. Our hypothesis was that participants' stress would decrease overtime.||-0.000|-0.140|=0.051
72622933|NCT03926247|144776092|OTHER|Within-group longitudinal analysis (no comparison groups)|Mean Difference (Final Values)|-0.041|STANDARD_ERROR_OF_MEAN|0.029|=|0.211|TWO_SIDED|95.0|-0.106|0.023|||Mixed Models Analysis|||Analyses were conducted using a mixed effects linear model to calculate least square means across the 4 timepoints. This was a longitudinal within-group analysis with 4 timepoints of data nested within 56 individuals. Our hypothesis was that participants' social support would increase overtime.||0.023|-0.106|=0.211
72397190|NCT04615923|144300564|SUPERIORITY||Median Difference (Net)|0.01|STANDARD_ERROR_OF_MEAN|0.426||0.9903|TWO_SIDED|95.0|-0.83|0.84|||Mixed Models Analysis|Covariates include baseline use of edaravone and riluzole, months since symptom onset, and pre-baseline ALSFRS-R slope.|Pridopidine 24-week change from baseline relative to placebo 24-week change from baseline.|||0.84|-0.83|0.9903
72397191|NCT04615923|144300565|SUPERIORITY|Analysis performed using interval-censored survival analysis. This type of model accommodates interval censoring between ALSFRS-R assessments|Hazard Ratio (HR)|0.93|||||TWO_SIDED|95.0|0.69|1.27|||Regression, Cox|Interval censored cox model adjusted for time since symptom onset, pre-baseline change in ALSFRS-R, baseline use of edaravone, riluzole, and neudexta||||1.27|0.69|
72397192|NCT04615923|144300566|SUPERIORITY||Mean Difference (Net)|-1.78|STANDARD_ERROR_OF_MEAN|3.285||0.5888|TWO_SIDED|95.0|-8.23|4.67|||Mixed Models Analysis|Covariates include baseline use of edaravone and riluzole, months since symptom onset, and pre-baseline ALSFRS-R slope.|Pridopidine 24-week change from baseline relative to placebo 24-week change from baseline.|||4.67|-8.23|0.5888
72397193|NCT04615923|144300567|SUPERIORITY|||||||0.969|||||||Log Rank|||||||0.9690
72397194|NCT02282020|144300568|SUPERIORITY||Odds Ratio (OR)|2.53||||0.002|TWO_SIDED|95.0|1.4|4.58|||Regression, Logistic|Model includes a factor for time to disease progression after the end of last platinum based chemotherapy (6-12 months vs \> 12 months)|An odds ratio \>1 favours the olaparib arm|||4.58|1.40|0.002
72397195|NCT02282020|144300569|SUPERIORITY||Hazard Ratio (HR)|0.62||||0.013|TWO_SIDED|95.0|0.43|0.91||Determined using a log-rank test with a factor for time to disease progression after the end of last platinum based chemotherapy (6-12 months vs \> 12 months).|Log Rank||A hazard ratio \< 1 favours the olaparib arm|||0.91|0.43|0.013
72471685|NCT00474526|144466779|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA1A over LA1B, the lower limit of the two-sided 95% CI for the ratio of pneumococcal GMCs (GMCLA1A / GMCLA1B) had to be greater than 0.50.|Ratio of GMCs|0.81|||||TWO_SIDED|95.0|0.54|1.2|||ANOVA|||PnC 6B (Post-vaccination GMC; group ratio LA1A:LA1B)||1.2|0.54|
72471686|NCT00474526|144466779|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA1A over LA1B, the lower limit of the two-sided 95% CI for the ratio of pneumococcal GMCs (GMCLA1A / GMCLA1B) had to be greater than 0.50.|Ratio of GMCs|0.74|||||TWO_SIDED|95.0|0.58|0.94|||ANOVA|||PnC 9V (Post-vaccination GMC; group ratio LA1A:LA1B)||0.94|0.58|
72622934|NCT03926247|144776093|OTHER|Within-group longitudinal analysis (no comparison groups)|Mean Difference (Final Values)|0.09|STANDARD_ERROR_OF_MEAN|0.053|=|0.074|TWO_SIDED|95.0|-0.008|0.201|||Mixed Models Analysis|||Analyses were conducted using a mixed effects linear model to calculate least square means across the 4 timepoints. This was a longitudinal within-group analysis with 4 timepoints of data nested within 56 individuals. Our hypothesis was that participants' access to resources would increase overtime.||0.201|-0.008|=0.074
72397196|NCT02282020|144300570|SUPERIORITY||Hazard Ratio (HR)|0.8||||0.229|TWO_SIDED|95.0|0.56|1.15||Determined using a log-rank test with a factor for time to disease progression after the end of last platinum based chemotherapy (6-12 months vs \> 12 months).|Log Rank||A hazard ratio \< 1 favours the olaparib arm|||1.15|0.56|0.229
72397197|NCT02282020|144300571|SUPERIORITY||Hazard Ratio (HR)|1.07||||0.714|TWO_SIDED|95.0|0.76|1.49||Determined using a log-rank test with a factor for time to disease progression after the end of last platinum based chemotherapy (6-12 months vs \> 12 months).|Log Rank||A hazard ratio \< 1 favours the olaparib arm|||1.49|0.76|0.714
72397198|NCT02282020|144300572|SUPERIORITY||Hazard Ratio (HR)|0.59||||0.005|TWO_SIDED|95.0|0.41|0.85||Determined using a log-rank test with a factor for time to disease progression after the end of last platinum based chemotherapy (6-12 months vs \> 12 months).|Log Rank||A hazard ratio \<1 favours the olaparib arm|||0.85|0.41|0.005
72397199|NCT02282020|144300573|SUPERIORITY||Hazard Ratio (HR)|0.49|||<|0.001|TWO_SIDED|95.0|0.35|0.69||Model included factors for number of prior chemotherapy regimens received for ovarian cancer (2 or 3 prior lines vs 4 or more lines) and time to disease progression after the end of last platinum based chemotherapy (6-12 months vs \> 12 months).|Log Rank||A hazard ratio \< 1 favours the olaparib arm|||0.69|0.35|<0.001
72397200|NCT02282020|144300574|SUPERIORITY||Hazard Ratio (HR)|0.75||||0.089|TWO_SIDED|95.0|0.53|1.05||Model included factors for number of prior chemotherapy regimens received for ovarian cancer (2 or 3 prior lines vs 4 or more lines) and time to disease progression after the end of last platinum based chemotherapy (6-12 months vs \> 12 months).|Log Rank||A hazard ratio \< 1 favours the olaparib arm|||1.05|0.53|0.089
72397201|NCT02282020|144300575|SUPERIORITY||Hazard Ratio (HR)|0.2|||<|0.001|TWO_SIDED|95.0|0.14|0.29||Model included factors for number of prior chemotherapy regimens received for ovarian cancer (2 or 3 prior lines vs 4 or more lines) and time to disease progression after the end of last platinum based chemotherapy (6-12 months vs \> 12 months).|Log Rank||A hazard ratio \< 1 favours the olaparib arm|||0.29|0.14|<0.001
72397202|NCT02282020|144300578|SUPERIORITY||Mean Difference (Final Values)|2.5||||0.108|TWO_SIDED|95.0|-0.5|5.5|||Mixed Models Analysis|Model includes factors for patient, treatment, visit, treatment by visit interaction, baseline TOI score and baseline TOI score by visit interaction.||||5.5|-0.5|0.108
72397203|NCT02282020|144300579|SUPERIORITY||Odds Ratio (OR)|2.24||||0.092|TWO_SIDED|95.0|0.88|6.86||Estimated from an unadjusted logistic regression model|Regression, Logistic||An odds ratio \> 1 favours the olaparib arm|||6.86|0.88|0.092
72397204|NCT02282020|144300580|SUPERIORITY||Odds Ratio (OR)|2.4||||0.004|TWO_SIDED|95.0|1.32|4.39||Determined using a log-rank test with a factor for time to disease progression after the end of last platinum based chemotherapy (6-12 months vs \> 12 months).|Regression, Logistic||An odds ratio \> 1 favours the olaparib arm|||4.39|1.32|0.004
72397205|NCT02282020|144300581|SUPERIORITY||Hazard Ratio (HR)|0.62||||0.014|TWO_SIDED|95.0|0.42|0.91||Determined using a log-rank test with a factor for time to disease progression after the end of last platinum based chemotherapy (6-12 months vs \> 12 months).|Log Rank||A hazard ratio \< 1 favours the olaparib arm|||0.91|0.42|0.014
72506071|NCT02639182|144543810|SUPERIORITY|The difference between treatment groups was tested using a stratified log rank test at a one-sided 0.1 significance level.|Hazard Ratio (HR)|1.423||||0.11|TWO_SIDED|95.0|0.924|2.192||The stratification factors were the ECOG PS at baseline and the number of prior systemic RCC regimens, without any other covariate(s). The model contained terms for treatment group and stratum.|Log Rank|||||2.192|0.924|0.110
72397206|NCT02282020|144300582|SUPERIORITY||Hazard Ratio (HR)|0.8||||0.213|TWO_SIDED|95.0|0.56|1.14||Determined using a log-rank test with a factor for time to disease progression after the end of last platinum based chemotherapy (6-12 months vs \> 12 months).|Log Rank||A hazard ratio \< 1 favours the olaparib arm|||1.14|0.56|0.213
72397207|NCT02282020|144300583|SUPERIORITY||Hazard Ratio (HR)|1.07||||0.699|TWO_SIDED|95.0|0.76|1.51||Determined using a log-rank test with a factor for time to disease progression after the end of last platinum based chemotherapy (6-12 months vs \> 12 months).|Log Rank||A hazard ratio \< 1 favours the olaparib arm|||1.51|0.76|0.699
72397208|NCT02282020|144300584|SUPERIORITY||Hazard Ratio (HR)|0.18|||<|0.001|TWO_SIDED|95.0|0.12|0.27||Model included factors for number of prior chemotherapy regimens received for ovarian cancer (2 or 3 prior lines vs 4 or more lines) and time to disease progression after the end of last platinum based chemotherapy (6-12 months vs \> 12 months).|Log Rank||A hazard ratio \< 1 favours the olaparib arm|||0.27|0.12|<0.001
72506072|NCT02639182|144543811|SUPERIORITY||Odds Ratio (OR)|0.4||||0.062|TWO_SIDED|95.0|0.1|1.1||A Cochran-Mantel-Haenszel (CMH) analysis of the ORR, stratified for baseline ECOG-PS and number of prior systemic therapies for RCC, was conducted at a two-sided significance level of 0.05.|Cochran-Mantel-Haenszel|Stratified Mantel-Haenszel estimate of the odds ratio for experiencing objective response, with the axitinib arm as the reference level, was reported.||||1.1|0.1|0.062
72506073|NCT02639182|144543812|SUPERIORITY||Hazard Ratio (HR)|0.376||||0.439||95.0|0.031|4.482||The stratification factors were the ECOG PS at baseline and the number of prior systemic RCC regimens, without any other covariate(s). The model contained terms for treatment group and stratum.|Log Rank|The difference between treatment groups was tested using a stratified log rank test at a one-sided 0.1 significance level.||||4.482|0.031|0.439
72506074|NCT02639182|144543813|SUPERIORITY|||||||0.746||||||Test conducted at a 2-sided significance level of 0.05. The stratification factors were the ECOG PS at baseline and number of prior systemic RCC regimens.|Log Rank|||||||0.746
72565731|NCT02709486|144662693|SUPERIORITY||Odds Ratio (OR)|1.25||||0.3435|TWO_SIDED|95.0|0.79|1.98|||Regression, Logistic|||Week 24, \>=70%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||1.98|0.79|0.3435
72397209|NCT02282020|144300585|SUPERIORITY||Hazard Ratio (HR)|0.46|||<|0.001|TWO_SIDED|95.0|0.33|0.66||Model included factors for number of prior chemotherapy regimens received for ovarian cancer (2 or 3 prior lines vs 4 or more lines) and time to disease progression after the end of last platinum based chemotherapy (6-12 months vs \> 12 months).|Log Rank||A hazard ratio \< 1 favours the olaparib arm|||0.66|0.33|<0.001
72397210|NCT02282020|144300586|SUPERIORITY||Hazard Ratio (HR)|0.72||||0.055|TWO_SIDED|95.0|0.51|1.01||Model included factors for number of prior chemotherapy regimens received for ovarian cancer (2 or 3 prior lines vs 4 or more lines) and time to disease progression after the end of last platinum based chemotherapy (6-12 months vs \> 12 months).|Log Rank||A hazard ratio \< 1 favours the olaparib arm|||1.01|0.51|0.055
72397211|NCT02328755|144300622|OTHER|Single group|cumulative incidence|0.39|||||TWO_SIDED|95.0|0.24|0.58||||||The analysis applies only to the first row, for recipients of HLA-matched HCT who received the phase II MTD (180mcg) peg-IFN-a (n=31).||0.58|0.24|
72397212|NCT02328755|144300623|OTHER|Single group|Kaplan-Meier|55.0|||||TWO_SIDED|95.0|40.0|75.0||||||The analysis applies only to the first row, data at 6 months, for recipients of HLA-matched HCT who received the phase II MTD (180mcg) peg-IFN-a (n=31).|Survival proportion estimates at 6 months and 2 years were calculated using Kaplan-Meier methods, and the 2-sided, 95% confidence intervals calculated by the Greenwood method.|75|40|
72397213|NCT02328755|144300623|OTHER|Single group|Kaplan-Meier|33.0|||||TWO_SIDED|95.0|19.0|58.0||||||The analysis applies only to the 3rd row, data at 24 months, for recipients of HLA-matched HCT who received the phase II MTD (180mcg) peg-IFN-a (n=31).|Survival proportion estimates at 6 months and 2 years were calculated using Kaplan-Meier methods, and the 2-sided, 95% confidence intervals calculated by the Greenwood method.|58|19|
72397214|NCT02328755|144300624|OTHER|Single group|||||||||||||||||Survival proportion estimates at 6 months and 2 years were calculated using Kaplan-Meier methods, and the 2-sided, 95% confidence intervals calculated by the Greenwood method.|||
72397215|NCT02328755|144300625|OTHER|Single group|||||||||||||||||GVHD proportion estimates and corresponding 95% confidence intervals were calculated using methods of Fine and Gray.|||
72397216|NCT02328755|144300626|OTHER|Single group|||||||||||||||||Non-relapse mortality estimates and corresponding 95% confidence intervals were calculated using methods of Fine and Gray.|||
72397217|NCT05022784|144300628|OTHER||||||<|0.0001|||||||ANOVA|||The statistical method applied in this analysis is Analysis of Variance (ANOVA), which compares the mean value in each group and tests if they are significantly different via a fixed-effect regression model.||||<.0001
72397218|NCT05022784|144300629|OTHER||||||<|0.0001|||||||Chi-squared|||The statistical method applied in this analysis is Chi-squared hypothesis test, which tested if the count in each group was impacted by any confounding variable.||||<.0001
72565732|NCT02709486|144662693|SUPERIORITY||Odds Ratio (OR)|3.3||||0.0236|TWO_SIDED|95.0|1.17|9.27|||Regression, Logistic|||Week 24, \>=90%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||9.27|1.17|0.0236
72397219|NCT05022784|144300630|OTHER|||||||0.37|||||||Chi-squared|||The statistical method applied in this analysis is Chi-squared hypothesis test, which tested if the count in each group was impacted by any confounding variable.||||0.37
72397220|NCT05022784|144300631|OTHER|||||||0.477|||||||Chi-squared|||The statistical method applied in this analysis is Chi-squared hypothesis test, which tested if the count in each group was impacted by any confounding variable.||||0.477
72397221|NCT05022784|144300632|OTHER|||||||0.644|||||||ANOVA|||The statistical method applied in this analysis is Analysis of Variance (ANOVA), which compared the mean value in each group and tests if they are significantly different via a fixed-effect regression model.||||0.644
72397222|NCT05022784|144300633|OTHER|||||||0.206|||||||ANOVA|||The statistical method applied in this analysis is Analysis of Variance (ANOVA), which compared the mean value in each group and tests if they are significantly different via a fixed-effect regression model.||||0.206
72397223|NCT05022784|144300634|OTHER|||||||0.052|||||||Chi-squared|||The statistical method applied in this analysis is Chi-squared hypothesis test, which tested if the count in each group was impacted by any confounding variable.||||0.052
72397224|NCT05022784|144300635|OTHER|||||||0.044|||||||Chi-squared|||The statistical method applied in this analysis is Chi-squared hypothesis test, which tested if the count in each group was impacted by any confounding variable.||||0.044
72397225|NCT05022784|144300636|OTHER|||||||0.525|||||||Chi-squared|||The statistical method applied in this analysis is Chi-squared hypothesis test, which tested if the count in each group was impacted by any confounding variable.||||0.525
72565733|NCT02709486|144662693|SUPERIORITY||Odds Ratio (OR)|3.14||||0.0296|TWO_SIDED|95.0|1.12|8.81|||Regression, Logistic|||Week 24, \>=90%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||8.81|1.12|0.0296
72565734|NCT02709486|144662695|SUPERIORITY||Odds Ratio (OR)|2.14||||0.0132|TWO_SIDED|95.0|1.17|3.9|||Regression, Logistic|||Week 2: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline patient global assessment of osteoarthritis scale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.90|1.17|0.0132
72397226|NCT05022784|144300637|OTHER|||||||0.024|||||||Chi-squared|||The statistical method applied in this analysis is Chi-squared hypothesis test, which tested if the count in each group was impacted by any confounding variable.||||0.024
72397227|NCT05022784|144300638|OTHER|||||||0.016|||||||Chi-squared|||The statistical method applied in this analysis is Chi-squared hypothesis test, which tested if the count in each group was impacted by any confounding variable.||||0.016
72397228|NCT05022784|144300639|OTHER|||||||0.913|||||||Chi-squared|||The statistical method applied in this analysis is Chi-squared hypothesis test, which tested if the count in each group was impacted by any confounding variable.||||0.913
72397229|NCT05022784|144300640|OTHER|||||||0.448|||||||Chi-squared|||The statistical method applied in this analysis is Chi-squared hypothesis test, which tested if the count in each group was impacted by any confounding variable.||||0.448
72397230|NCT05022784|144300641|OTHER|||||||0.515|||||||Chi-squared|||The statistical method applied in this analysis is Chi-squared hypothesis test, which tested if the count in each group was impacted by any confounding variable.||||0.515
72397231|NCT05022784|144300642|OTHER|||||||0.829|||||||Chi-squared|||The statistical method applied in this analysis is Chi-squared hypothesis test, which tested if the count in each group was impacted by any confounding variable.||||0.829
72397232|NCT05022784|144300643|OTHER|||||||0.471|||||||Chi-squared|||The statistical method applied in this analysis is Chi-squared hypothesis test, which tested if the count in each group was impacted by any confounding variable.||||0.471
72397233|NCT05022784|144300644|OTHER|||||||0.915|||||||Chi-squared|||The statistical method applied in this analysis is Chi-squared hypothesis test, which tested if the count in each group was impacted by any confounding variable.||||0.915
72397234|NCT05022784|144300645|OTHER|||||||0.19|||||||Chi-squared|||||||0.190
72397235|NCT05022784|144300646|OTHER|||||||0.928|||||||Chi-squared|||The statistical method applied in this analysis is Chi-squared hypothesis test, which tested if the count in each group was impacted by any confounding variable.||||0.928
72397236|NCT05022784|144300647|OTHER|||||||0.49|||||||Chi-squared|||The statistical method applied in this analysis is Chi-squared hypothesis test, which tested if the count in each group was impacted by any confounding variable.||||0.490
72397237|NCT05022784|144300648|OTHER|||||||0.667|||||||Chi-squared|||The statistical method applied in this analysis is Chi-squared hypothesis test, which tested if the count in each group was impacted by any confounding variable.||||0.667
72397238|NCT05022784|144300649|OTHER|||||||0.032|||||||ANOVA|||The statistical method applied in this analysis is Analysis of Variance (ANOVA), which compared the mean value in each group and tests if they are significantly different via a fixed-effect regression model.||||0.032
72397239|NCT05022784|144300650|OTHER|||||||0.721|||||||ANOVA|||The statistical method applied in this analysis is Analysis of Variance (ANOVA), which compared the mean value in each group and tests if they are significantly different via a fixed-effect regression model.||||0.721
72397240|NCT05022784|144300651|OTHER|||||||0.352|||||||ANOVA|||The statistical method applied in this analysis is Analysis of Variance (ANOVA), which compared the mean value in each group and tests if they are significantly different via a fixed-effect regression model.||||0.352
72622935|NCT03926247|144776094|OTHER|Within-group longitudinal analysis (no comparison groups)=|Mean Difference (Final Values)|-0.119|STANDARD_ERROR_OF_MEAN|0.061|=|0.089|TWO_SIDED|95.0|-0.257|0.017|||Mixed Models Analysis|||Analyses were conducted using a mixed effects linear model to calculate least square means across the 4 timepoints. This was a longitudinal within-group analysis with 4 timepoints of data nested within 56 individuals. Our hypothesis was that participants' difficulty accessing resources would decrease overtime.||0.017|-0.257|=0.089
72397241|NCT05022784|144300652|OTHER|||||||0.136|||||||Chi-squared|||The statistical method applied in this analysis is Chi-squared hypothesis test, which tested if the count in each group was impacted by any confounding variable.||||0.136
72397242|NCT05022784|144300653|OTHER|||||||0.27|||||||ANOVA|||The statistical method applied in this analysis is Analysis of Variance (ANOVA), which compared the mean value in each group and tests if they are significantly different via a fixed-effect regression model.||||0.270
72397243|NCT05022784|144300654|OTHER|||||||0.306|||||||ANOVA|||The statistical method applied in this analysis is Analysis of Variance (ANOVA), which compared the mean value in each group and tests if they are significantly different via a fixed-effect regression model.||||0.306
72397244|NCT05022784|144300655|OTHER|||||||0.145|||||||ANOVA|||The statistical method applied in this analysis is Analysis of Variance (ANOVA), which compared the mean value in each group and tests if they are significantly different via a fixed-effect regression model.||||0.145
72471687|NCT00474526|144466779|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA1A over LA1B, the lower limit of the two-sided 95% CI for the ratio of pneumococcal GMCs (GMCLA1A / GMCLA1B) had to be greater than 0.50.|Ratio of GMCs|0.65|||||TWO_SIDED|95.0|0.51|0.82|||ANOVA|||PnC 14 (Post-vaccination GMC; group ratio LA1A:LA1B)||0.82|0.51|
72397245|NCT05022784|144300656|OTHER|||||||0.109|||||||ANOVA|||The statistical method applied in this analysis is Analysis of Variance (ANOVA), which compared the mean value in each group and tests if they are significantly different via a fixed-effect regression model.||||0.109
72397246|NCT05022784|144300657|OTHER|||||||0.454|||||||ANOVA|||The statistical method applied in this analysis is Analysis of Variance (ANOVA), which compared the mean value in each group and tests if they are significantly different via a fixed-effect regression model.||||0.454
72471688|NCT00474526|144466779|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA1A over LA1B, the lower limit of the two-sided 95% CI for the ratio of pneumococcal GMCs (GMCLA1A / GMCLA1B) had to be greater than 0.50.|Ratio of GMCs|0.78|||||TWO_SIDED|95.0|0.6|1.01|||ANOVA|||PnC 18C (Post-vaccination GMC; group ratio LA1A:LA1B)||1.01|0.6|
72506075|NCT02639182|144543814|SUPERIORITY|A CMH analysis of the DCR, stratified for baseline ECOG-PS and number of prior systemic therapies for RCC, was conducted at a two-sided significance level of 0.05.|Odds Ratio (OR)|0.5||||0.152|TWO_SIDED|95.0|0.2|1.3||The stratified Mantel-Haenszel estimate of the odds ratio for experiencing objective response, with the axitinib arm as the reference level, was reported as a measure of relative treatment effect, along with its two-sided 95% CI.|Cochran-Mantel-Haenszel|||||1.3|0.2|0.152
72506076|NCT03069690|144543831|SUPERIORITY||Mean Difference (Net)|-0.3996|STANDARD_ERROR_OF_MEAN|2.665||0.8|TWO_SIDED|95.0|-5.649|4.85||The value was not adjusted for multiple comparisons.|ANCOVA|||||4.850|-5.649|.80
72506077|NCT03069690|144543831|SUPERIORITY||Mean Difference (Net)|-3.387|STANDARD_ERROR_OF_MEAN|2.755||0.8|TWO_SIDED|95.0|-8.813|2.039||The value was not adjusted for multiple comparisons.|ANCOVA|||||2.039|-8.813|.80
72506078|NCT03069690|144543831|SUPERIORITY||Mean Difference (Net)|-1.1729|STANDARD_ERROR_OF_MEAN|2.72||0.8|TWO_SIDED|95.0|-6.53|4.184||The value was not adjusted for multiple comparisons.|ANCOVA|||||4.184|-6.530|.80
72506079|NCT02385123|144543840|OTHER||||||||||||||||||A single group analysis was used to determine this outcome measure. These are basic science, hypothesis-generating studies with limited numbers of participants and no control group. The outcomes have no comparisons built into them - the outcomes are stating what the cell counts are, what the antibody titers are, what percentage of people seroconverted, etc. As such, we cannot report any p-values etc. for comparisons (e.g. with unvaccinated people).|||
72397247|NCT05022784|144300658|OTHER|||||||0.96|||||||ANOVA|||The statistical method applied in this analysis is Analysis of Variance (ANOVA), which compared the mean value in each group and tests if they are significantly different via a fixed-effect regression model.||||0.960
72397248|NCT05022784|144300659|OTHER|||||||0.265|||||||ANOVA|||The statistical method applied in this analysis is Analysis of Variance (ANOVA), which compared the mean value in each group and tests if they are significantly different via a fixed-effect regression model.||||0.265
72397249|NCT05022784|144300660|OTHER|||||||0.026|||||||ANOVA|||The statistical method applied in this analysis is Analysis of Variance (ANOVA), which compared the mean value in each group and tests if they are significantly different via a fixed-effect regression model.||||0.026
72397250|NCT05022784|144300661|OTHER|||||||0.016|||||||ANOVA|||The statistical method applied in this analysis is Analysis of Variance (ANOVA), which compared the mean value in each group and tests if they are significantly different via a fixed-effect regression model.||||0.016
72397251|NCT05022784|144300662|OTHER|||||||0.937|||||||ANOVA|||The statistical method applied in this analysis is Analysis of Variance (ANOVA), which compared the mean value in each group and tests if they are significantly different via a fixed-effect regression model.||||0.937
72397252|NCT05022784|144300663|OTHER|||||||0.948|||||||ANOVA|||The statistical method applied in this analysis is Analysis of Variance (ANOVA), which compared the mean value in each group and tests if they are significantly different via a fixed-effect regression model.||||0.948
72397253|NCT05022784|144300664|OTHER|||||||0.574|||||||ANOVA|||The statistical method applied in this analysis is Analysis of Variance (ANOVA), which compared the mean value in each group and tests if they are significantly different via a fixed-effect regression model.||||0.574
72397254|NCT05022784|144300665|OTHER|||||||0.491|||||||ANOVA|||The statistical method applied in this analysis is Analysis of Variance (ANOVA), which compared the mean value in each group and tests if they are significantly different via a fixed-effect regression model.||||0.491
72397255|NCT05022784|144300666|OTHER|||||||0.432|||||||ANOVA|||The statistical method applied in this analysis is Analysis of Variance (ANOVA), which compared the mean value in each group and tests if they are significantly different via a fixed-effect regression model.||||0.432
72397256|NCT00708162|144300668|NON_INFERIORITY_OR_EQUIVALENCE|Null hypothesis: the EVG group was at least 10% worse than the RAL group with respect to percentage of participants achieving and maintaining HIV-1 RNA \< 50 copies/mL through Week 48; alternative hypothesis: the EVG group was less than 10% worse than the RAL group.|Difference in percentages|1.1|||||TWO_SIDED|95.0|-6.0|8.2|||||The difference in percentages and its 95% confidence interval (CI) were based on stratum-adjusted HIV-1 RNA level and the class of second agent (NRTI or other classes) using Mantel-Haenszel (MH) proportions and normal approximation.|The planned sample size of 700 HIV-1 infected participants, (350 in each group) was estimated to provide at least 85% power to establish noninferiority in the percentage of participants achieving and maintaining confirmed HIV-1 RNA \< 50 copies/mL through Week 48. For sample size and power computation, it was assumed that both elvitegravir and raltegravir arms have a response rate of 0.74, that a noninferiority margin was 0.10, and that the significance level of the test was 1-sided 0.025 level.||8.2|-6.0|
72397257|NCT00708162|144300669|NON_INFERIORITY_OR_EQUIVALENCE|Null hypothesis: the EVG arm was at least 10% worse than the RAL arm with respect to percentage of participants achieving and maintaining HIV-1 RNA \< 50 copies/mL through Week 48; alternative hypothesis: the EVG arm was less than 10% worse than the RAL arm.|Difference in percentages|2.6|||||TWO_SIDED|95.0|-4.6|9.9|||||The difference in percentages and its 95% CI were based on stratum-adjusted HIV-1 RNA level and the class of second agent (NRTI or other classes) using MH proportions and normal approximation.|||9.9|-4.6|
72397258|NCT00708162|144300670|SUPERIORITY_OR_OTHER||Difference in percentages|0.9|||||TWO_SIDED|95.0|-6.0|7.7|||||The difference in percentages and its 95% CI were based on stratum-adjusted HIV-1 RNA level and the class of second agent (NRTI or other classes) using MH proportions and normal approximation.|||7.7|-6.0|
72397259|NCT00708162|144300671|SUPERIORITY_OR_OTHER||Difference in percentages|0.9|||||TWO_SIDED|95.0|-6.4|8.2|||||The difference in percentages and its 95% CI were based on stratum-adjusted HIV-1 RNA level and the class of second agent (NRTI or other classes) using MH proportions and normal approximation.|||8.2|-6.4|
72397260|NCT00708162|144300672|SUPERIORITY_OR_OTHER||Difference in percentages|2.2|||||TWO_SIDED|95.0|-5.0|9.3|||||The difference in percentages and its 95% CI were based on stratum-adjusted HIV-1 RNA level and the class of second agent (NRTI or other classes) using MH proportions and normal approximation.|||9.3|-5.0|
72397261|NCT00708162|144300673|SUPERIORITY_OR_OTHER||Difference in percentages|-0.5|||||TWO_SIDED|95.0|-7.9|6.8|||||The difference in percentages and its 95% CI were based on stratum-adjusted HIV-1 RNA level and the class of second agent (NRTI or other classes) using MH proportions and normal approximation.|||6.8|-7.9|
72397262|NCT00708162|144300678|SUPERIORITY_OR_OTHER||Difference in percentages|0.2|||||TWO_SIDED|95.0|-6.9|7.3|||||The difference in percentages and its 95% CI were based on stratum-adjusted HIV-1 RNA level and the class of second agent (NRTI or other classes) using MH proportions and normal approximation.|||7.3|-6.9|
72397263|NCT00708162|144300679|SUPERIORITY_OR_OTHER||Difference in percentages|-2.9|||||TWO_SIDED|95.0|-10.2|4.4|||||The difference in percentages and its 95% CI were based on stratum-adjusted HIV-1 RNA level and the class of second agent (NRTI or other classes) using MH proportions and normal approximation.|||4.4|-10.2|
72397264|NCT00708162|144300680|SUPERIORITY_OR_OTHER||Difference in percentages|-2.0|||||TWO_SIDED|95.0|-8.6|4.7|||||The difference in percentages and its 95% CI were based on stratum-adjusted HIV-1 RNA level and the class of second agent (NRTI or other classes) using MH proportions and normal approximation.|||4.7|-8.6|
72397265|NCT00708162|144300681|SUPERIORITY_OR_OTHER||Difference in percentages|-1.7|||||TWO_SIDED|95.0|-8.8|5.5|||||The difference in percentages and its 95% CI were based on stratum-adjusted HIV-1 RNA level and the class of second agent (NRTI or other classes) using MH proportions and normal approximation.|||5.5|-8.8|
72397266|NCT00708162|144300682|SUPERIORITY_OR_OTHER||Difference in log10 copies/mL|0.01|||||TWO_SIDED|95.0|-0.16|0.19|||||The difference in least squares means (LSM) and its 95% CI were obtained using an analysis of variance model (ANOVA) adjusting for baseline HIV-1 RNA level and class of the second agent (NRTI or other classes).|||0.19|-0.16|
72397267|NCT00708162|144300683|SUPERIORITY_OR_OTHER||Difference in log10 copies/mL|0.05|||||TWO_SIDED|95.0|-0.12|0.22|||||The difference in LSM and its 95% CI were obtained using ANOVA adjusting for baseline HIV-1 RNA level and class of the second agent (NRTI or other classes).|||0.22|-0.12|
72397268|NCT00708162|144300684|SUPERIORITY_OR_OTHER||Difference in cells/mm^3|-9.0|||||TWO_SIDED|95.0|-33.0|16.0|||||The difference in LSM and its 95% CI were obtained using ANOVA adjusting for baseline HIV-1 RNA level and class of the second agent (NRTI or other classes).|||16|-33|
72397269|NCT00708162|144300685|SUPERIORITY_OR_OTHER||Difference in cells/mm^3|7.0|||||TWO_SIDED|95.0|-25.0|39.0|||||The difference in LSM and its 95% CI were obtained using ANOVA adjusting for baseline HIV-1 RNA level and class of the second agent (NRTI or other classes).|||39|-25|
72397270|NCT00708643|144300686|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.0047|STANDARD_ERROR_OF_MEAN|2.2863|||TWO_SIDED|98.75|-3.0047|2.7153|||Mixed Models Analysis||The mean difference is calculated as narafilcon A minus the habitual lens.|The alternative hypothesis is that narafilcon A will provide a lower level of limbal hyperemia than the habitual lens.||2.7153|-3.0047|
72397271|NCT00708643|144300687|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.0804|STANDARD_ERROR_OF_MEAN|0.7605|||TWO_SIDED|99.0|-0.0804|1.8821|||Mixed Models Analysis||The mean difference is calculated as narafilcon A minus habitual lens.|The alternative hypothesis is that narafilcon A provides better comfort than the habitual lens by having a lower rating on the scale.||1.8821|-0.0804|
72397272|NCT00708643|144300688|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2228|STANDARD_ERROR_OF_MEAN|1.7002|||TWO_SIDED|99.0|0.2228|4.6564|||Mixed Models Analysis||The mean difference is calculated as narafilcon A minus the habitual lens.|The alternative hypothesis is that narafilcon A provides a lowe level of upper lid margin staining than the habitual lens.||4.6564|0.2228|
72397273|NCT00708643|144300689|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.2596|STANDARD_ERROR_OF_MEAN|1.1873|||TWO_SIDED|98.75|1.2596|4.2599|||Mixed Models Analysis||The mean difference is calculated as narafilcon A minus the habitual lens.|||4.2599|1.2596|
72397274|NCT00708643|144300690|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8625|STANDARD_ERROR_OF_MEAN|2.3407|||TWO_SIDED|98.75|-0.8625|5.0524|||Mixed Models Analysis||The mean difference is calculated as narafilcon A minus habitual lens.|The alternative hypothesis is that narafilcon A provides a lower level of tarsal hyperemia than the habitual lens.||5.0524|-0.8625|
72397275|NCT00708643|144300691|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.241|STANDARD_ERROR_OF_MEAN|1.6975|||TWO_SIDED|98.75|-0.241|4.0043|||Mixed Models Analysis||The mean difference is calculated as narafilcon A minus habitual lens.|The alternative hypothesis is that narafilcon A provides lower levels of corneal staining than the habitual lens.||4.0043|-0.2410|
72397276|NCT02772081|144300709|SUPERIORITY||Adjusted difference|-15.4||||0.39|TWO_SIDED|95.0|-47.9|17.1|||Cochran-Mantel-Haenszel|||First Administration; Treatment comparison. Adjusted difference, its 95% confidence interval (CI) and p-value are estimated using Cochran-Mantel-Haenszel test||17.1|-47.9|0.390
72397277|NCT02772081|144300715|SUPERIORITY||Median Difference (Final Values)|5.0||||0.563|TWO_SIDED|95.0|-13.8|23.8|||Wilcoxon (Mann-Whitney)|||Duration of standalone oxygen supplementation||23.8|-13.8|0.563
72397278|NCT02772081|144300715|SUPERIORITY||Median Difference (Final Values)|1.0||||0.612|TWO_SIDED|95.0|-19.7|21.7|||Wilcoxon (Mann-Whitney)|||Duration of NIV||21.7|-19.7|0.612
72397279|NCT02772081|144300718|SUPERIORITY||Adjusted mean difference|-0.619||||0.137|TWO_SIDED|95.0|-1.447|0.21|||Mixed model for repeated measures|||T0, Treatment comparison. The analysis was based on an mixed model for repeated measures (MMRM) with treatment, timepoint, treatment by timepoint interaction, and GA group as fixed effects and pre-procedure SpO2/FiO2 as a covariate.||0.210|-1.447|0.137
72397280|NCT02772081|144300718|SUPERIORITY||Adjusted mean difference|0.268||||0.534|TWO_SIDED|95.0|-0.604|1.14|||Mixed model for repeated measures|||5 min, Treatment comparison. The analysis was based on an MMRM with treatment, timepoint, treatment by timepoint interaction, and GA group as fixed effects and pre-procedure SpO2/FiO2 as a covariate.||1.140|-0.604|0.534
72397281|NCT02772081|144300718|SUPERIORITY||Adjusted mean difference|0.27||||0.53|TWO_SIDED|95.0|-0.597|1.136|||Mixed model for repeated measures|||15 min, Treatment comparison. The analysis was based on an MMRM with treatment, timepoint, treatment by timepoint interaction, and GA group as fixed effects and pre-procedure SpO2/FiO2 as a covariate.||1.136|-0.597|0.530
72397282|NCT02772081|144300718|SUPERIORITY||Adjusted mean difference|0.641||||0.091|TWO_SIDED|95.0|-0.108|1.389|||Mixed model for repeated measures|||30 min, Treatment comparison. The analysis was based on an MMRM with treatment, timepoint, treatment by timepoint interaction, and GA group as fixed effects and pre-procedure SpO2/FiO2 as a covariate.||1.389|-0.108|0.091
72397283|NCT02772081|144300718|SUPERIORITY||Adjusted mean difference|0.463||||0.04|TWO_SIDED|95.0|0.023|0.903|||Mixed model for repeated measures|||1 hour, Treatment comparison. The analysis was based on an MMRM with treatment, timepoint, treatment by timepoint interaction, and GA group as fixed effects and pre-procedure SpO2/FiO2 as a covariate.||0.903|0.023|0.040
72397284|NCT02772081|144300718|SUPERIORITY||Adjusted mean difference|0.166||||0.532|TWO_SIDED|95.0|-0.371|0.703|||Mixed model for repeated measures|||6 hours, Treatment comparison. The analysis was based on an MMRM with treatment, timepoint, treatment by timepoint interaction, and GA group as fixed effects and pre-procedure SpO2/FiO2 as a covariate.||0.703|-0.371|0.532
72397285|NCT02772081|144300718|SUPERIORITY||Adjusted mean difference|0.048||||0.877|TWO_SIDED|95.0|-0.578|0.674|||Mixed model for repeated measures|||12 hours, Treatment comparison. The analysis was based on an MMRM with treatment, timepoint, treatment by timepoint interaction, and GA group as fixed effects and pre-procedure SpO2/FiO2 as a covariate.||0.674|-0.578|0.877
72397286|NCT02772081|144300718|SUPERIORITY||Adjusted mean difference|0.244||||0.356|TWO_SIDED|95.0|-0.289|0.776|||Mixed model for repeated measures|||24 hours, Treatment comparison. The analysis was based on an MMRM with treatment, timepoint, treatment by timepoint interaction, and GA group as fixed effects and pre-procedure SpO2/FiO2 as a covariate.||0.776|-0.289|0.356
72565735|NCT02709486|144662695|SUPERIORITY||Odds Ratio (OR)|1.62||||0.1274|TWO_SIDED|95.0|0.87|3.02|||Regression, Logistic|||Week 2: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline patient global assessment of osteoarthritis scale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.02|0.87|0.1274
72565736|NCT02709486|144662695|SUPERIORITY||Odds Ratio (OR)|2.62||||0.0016|TWO_SIDED|95.0|1.44|4.76|||Regression, Logistic|||Week 4: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline patient global assessment of osteoarthritis scale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||4.76|1.44|0.0016
72397287|NCT02772081|144300718|SUPERIORITY||Adjusted mean difference|0.303||||0.258|TWO_SIDED|95.0|-0.235|0.841|||Mixed model for repeated measures|||48 hours, Treatment comparison. The analysis was based on an MMRM with treatment, timepoint, treatment by timepoint interaction, and GA group as fixed effects and pre-procedure SpO2/FiO2 as a covariate.||0.841|-0.235|0.258
72397288|NCT02772081|144300718|SUPERIORITY||Adjusted mean difference|0.022||||0.945|TWO_SIDED|95.0|-0.616|0.66|||Mixed model for repeated measures|||72 hours, Treatment comparison. The analysis was based on an MMRM with treatment, timepoint, treatment by timepoint interaction, and GA group as fixed effects and pre-procedure SpO2/FiO2 as a covariate.||0.660|-0.616|0.945
72397289|NCT02772081|144300718|SUPERIORITY||Adjusted mean difference|-0.075||||0.766|TWO_SIDED|95.0|-0.586|0.436|||Mixed model for repeated measures|||120 hours, Treatment comparison. The analysis was based on an MMRM with treatment, timepoint, treatment by timepoint interaction, and GA group as fixed effects and pre-procedure SpO2/FiO2 as a covariate.||0.436|-0.586|0.766
72397290|NCT02772081|144300719|SUPERIORITY||Adjusted mean difference|0.051||||0.59|TWO_SIDED|95.0|-0.141|0.243|||Mixed model for repeated measures|||T0, Treatment comparison. The analysis was based on an MMRM with treatment, timepoint, treatment by timepoint interaction, and GA group as fixed effects and pre-procedure FiO2 as a covariate.||0.243|-0.141|0.590
72397291|NCT02772081|144300719|SUPERIORITY||Adjusted mean difference|-0.051||||0.511|TWO_SIDED|95.0|-0.21|0.107|||Mixed model for repeated measures|||5 min, Treatment comparison. The analysis was based on an MMRM with treatment, timepoint, treatment by timepoint interaction, and GA group as fixed effects and pre-procedure FiO2 as a covariate.||0.107|-0.210|0.511
72397292|NCT02772081|144300719|SUPERIORITY||Adjusted mean difference|-0.05||||0.488|TWO_SIDED|95.0|-0.196|0.096|||Mixed model for repeated measures|||15 min, Treatment comparison. The analysis was based on an MMRM with treatment, timepoint, treatment by timepoint interaction, and GA group as fixed effects and pre-procedure FiO2 as a covariate.||0.096|-0.196|0.488
72397293|NCT02772081|144300719|SUPERIORITY||Adjusted mean difference|-0.11||||0.091|TWO_SIDED|95.0|-0.239|0.019|||Mixed model for repeated measures|||30 min, Treatment comparison. The analysis was based on an MMRM with treatment, timepoint, treatment by timepoint interaction, and GA group as fixed effects and pre-procedure FiO2 as a covariate.||0.019|-0.239|0.091
72397294|NCT02772081|144300719|SUPERIORITY||Adjusted mean difference|-0.024||||0.344|TWO_SIDED|95.0|-0.076|0.027|||Mixed model for repeated measures|||1 hour, Treatment comparison. The analysis was based on an MMRM with treatment, timepoint, treatment by timepoint interaction, and GA group as fixed effects and pre-procedure FiO2 as a covariate.||0.027|-0.076|0.344
72397295|NCT02772081|144300719|SUPERIORITY||Adjusted mean difference|-0.026||||0.376|TWO_SIDED|95.0|-0.084|0.033|||Mixed model for repeated measures|||6 hours, Treatment comparison. The analysis was based on an MMRM with treatment, timepoint, treatment by timepoint interaction, and GA group as fixed effects and pre-procedure FiO2 as a covariate.||0.033|-0.084|0.376
72397296|NCT02772081|144300719|SUPERIORITY||Adjusted mean difference|-0.04||||0.396|TWO_SIDED|95.0|-0.135|0.055|||Mixed model for repeated measures|||12 hours, Treatment comparison. The analysis was based on an MMRM with treatment, timepoint, treatment by timepoint interaction, and GA group as fixed effects and pre-procedure FiO2 as a covariate.||0.055|-0.135|0.396
72397297|NCT02772081|144300719|SUPERIORITY||Adjusted mean difference|-0.026||||0.268|TWO_SIDED|95.0|-0.074|0.021|||Mixed model for repeated measures|||24 hours, Treatment comparison. The analysis was based on an MMRM with treatment, timepoint, treatment by timepoint interaction, and GA group as fixed effects and pre-procedure FiO2 as a covariate.||0.021|-0.074|0.268
72397298|NCT02772081|144300719|SUPERIORITY||Adjusted mean difference|-0.037||||0.147|TWO_SIDED|95.0|-0.089|0.014|||Mixed model for repeated measures|||48 hours, Treatment comparison. The analysis was based on an MMRM with treatment, timepoint, treatment by timepoint interaction, and GA group as fixed effects and pre-procedure FiO2 as a covariate.||0.014|-0.089|0.147
72397299|NCT02772081|144300719|SUPERIORITY||Adjusted mean difference|0.0||||0.994|TWO_SIDED|95.0|-0.055|0.055|||Mixed model for repeated measures|||72 hours, Treatment comparison. The analysis was based on an MMRM with treatment, timepoint, treatment by timepoint interaction, and GA group as fixed effects and pre-procedure FiO2 as a covariate.||0.055|-0.055|0.994
72471689|NCT00474526|144466779|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA1A over LA1B, the lower limit of the two-sided 95% CI for the ratio of pneumococcal GMCs (GMCLA1A / GMCLA1B) had to be greater than 0.50.|Ratio of GMCs|0.77|||||TWO_SIDED|95.0|0.56|1.04|||ANOVA|||PnC 19F (Post-vaccination GMC; group ratio LA1A:LA1B)||1.04|0.56|
72397300|NCT02772081|144300719|SUPERIORITY||Adjusted mean difference|-0.004||||0.853|TWO_SIDED|95.0|-0.048|0.04|||Mixed model for repeated measures|||120 hours, Treatment comparison. The analysis was based on an MMRM with treatment, timepoint, treatment by timepoint interaction, and GA group as fixed effects and pre-procedure FiO2 as a covariate.||0.040|-0.048|0.853
72397301|NCT02772081|144300720|SUPERIORITY||Adjusted mean difference|-10.4||||0.09|TWO_SIDED|95.0|-22.6|1.7|||Mixed model for repeated measures|||T0; Treatment comparison. The analysis was based on an MMRM with treatment, timepoint, treatment by timepoint interaction, and GA group as fixed effects and pre-procedure SpO2 as a covariate.||1.7|-22.6|0.090
72397302|NCT02772081|144300720|SUPERIORITY||Adjusted mean difference|-0.3||||0.917|TWO_SIDED|95.0|-6.4|5.8|||Mixed model for repeated measures|||5 min; Treatment comparison. The analysis was based on an MMRM with treatment, timepoint, treatment by timepoint interaction, and GA group as fixed effects and pre-procedure SpO2 as a covariate.||5.8|-6.4|0.917
72471690|NCT00474526|144466779|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA1A over LA1B, the lower limit of the two-sided 95% CI for the ratio of pneumococcal GMCs (GMCLA1A / GMCLA1B) had to be greater than 0.50.|Ratio of GMCs|0.74|||||TWO_SIDED|95.0|0.54|1.01|||ANOVA|||PnC 23F (Post-vaccination GMC; group ratio LA1A:LA1B)||1.01|0.54|
72471691|NCT00474526|144466780|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA1A over LA1B, the lower limit of the two-sided 95% CI for the difference in rates (PLA1A - PLA1B) had to be greater than -10%.|Percentage difference|-2.0|||||TWO_SIDED|95.0|-9.6|5.2|||ANOVA|||PnC 4 (percentage difference (LA1A - LA1B))||5.2|-9.6|
72471692|NCT00474526|144466780|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA1A over LA1B, the lower limit of the two-sided 95% CI for the difference in rates (PLA1A - PLA1B) had to be greater than -10%.|Percentage difference|-2.0|||||TWO_SIDED|95.0|-11.9|7.3|||ANOVA|||PnC 6B (percentage difference (LA1A - LA1B))||7.3|-11.9|
72506080|NCT02385123|144543841|OTHER|A single group analysis was used to determine this outcome measure.|||||||||||||||||A single group analysis was used to determine this outcome measure. These are basic science, hypothesis-generating studies with limited numbers of participants and no control group. The outcomes have no comparisons built into them - the outcomes are stating what the cell counts are, what the antibody titers are, what percentage of people seroconverted, etc. As such, we cannot report any p-values etc. for comparisons (e.g. with unvaccinated people).|||
72565737|NCT02709486|144662695|SUPERIORITY||Odds Ratio (OR)|3.34|||<|0.0001|TWO_SIDED|95.0|1.84|6.03|||Regression, Logistic|||Week 4: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline patient global assessment of osteoarthritis scale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||6.03|1.84|<.0001
72397303|NCT02772081|144300720|SUPERIORITY||Adjusted mean difference|-1.5||||0.668|TWO_SIDED|95.0|-8.5|5.6|||Mixed model for repeated measures|||15 min; Treatment comparison. The analysis was based on an MMRM with treatment, timepoint, treatment by timepoint interaction, and GA group as fixed effects and pre-procedure SpO2 as a covariate.||5.6|-8.5|0.668
72397304|NCT02772081|144300720|SUPERIORITY||Adjusted mean difference|4.0||||0.149|TWO_SIDED|95.0|-1.5|9.6|||Mixed model for repeated measures|||30 min; Treatment comparison. The analysis was based on an MMRM with treatment, timepoint, treatment by timepoint interaction, and GA group as fixed effects and pre-procedure SpO2 as a covariate.||9.6|-1.5|0.149
72397305|NCT02772081|144300720|SUPERIORITY||Adjusted mean difference|1.8||||0.318|TWO_SIDED|95.0|-1.9|5.5|||Mixed model for repeated measures|||1 hour; Treatment comparison. The analysis was based on an MMRM with treatment, timepoint, treatment by timepoint interaction, and GA group as fixed effects and pre-procedure SpO2 as a covariate.||5.5|-1.9|0.318
72397306|NCT02772081|144300720|SUPERIORITY||Adjusted mean difference|1.6||||0.148|TWO_SIDED|95.0|-0.6|3.7|||Wilcoxon (Mann-Whitney)|||6 hour; Treatment comparison. The analysis was based on an MMRM with treatment, timepoint, treatment by timepoint interaction, and GA group as fixed effects and pre-procedure SpO2 as a covariate.||3.7|-0.6|0.148
72397307|NCT02772081|144300720|SUPERIORITY||Adjusted mean difference|3.3||||0.333|TWO_SIDED|95.0|-3.6|10.2|||Mixed model for repeated measures|||12 hours; Treatment comparison. The analysis was based on an MMRM with treatment, timepoint, treatment by timepoint interaction, and GA group as fixed effects and pre-procedure SpO2 as a covariate.||10.2|-3.6|0.333
72397308|NCT02772081|144300720|SUPERIORITY||Adjusted mean difference|0.9||||0.56|TWO_SIDED|95.0|-2.2|4.0|||Mixed model for repeated measures|||24 hours; Treatment comparison. The analysis was based on an MMRM with treatment, timepoint, treatment by timepoint interaction, and GA group as fixed effects and pre-procedure SpO2 as a covariate.||4.0|-2.2|0.560
72397309|NCT02772081|144300720|SUPERIORITY||Adjusted mean difference|2.0||||0.089|TWO_SIDED|95.0|-0.3|4.3|||Mixed model for repeated measures|||48 hours; Treatment comparison. The analysis was based on an MMRM with treatment, timepoint, treatment by timepoint interaction, and GA group as fixed effects and pre-procedure SpO2 as a covariate.||4.3|-0.3|0.089
72397310|NCT02772081|144300720|SUPERIORITY||Adjusted mean difference|1.9||||0.115|TWO_SIDED|95.0|-0.5|4.4|||Mixed model for repeated measures|||72 hours; Treatment comparison. The analysis was based on an MMRM with treatment, timepoint, treatment by timepoint interaction, and GA group as fixed effects and pre-procedure SpO2 as a covariate.||4.4|-0.5|0.115
72397311|NCT02772081|144300720|SUPERIORITY||Adjusted mean difference|1.1||||0.284|TWO_SIDED|95.0|-1.0|3.3|||Mixed model for repeated measures|||120 hours; Treatment comparison. The analysis was based on an MMRM with treatment, timepoint, treatment by timepoint interaction, and GA group as fixed effects and pre-procedure SpO2 as a covariate.||3.3|-1.0|0.284
72397312|NCT02772081|144300721|SUPERIORITY||Adjusted difference|-15.7||||0.22|TWO_SIDED|95.0|-39.6|8.2|||Cochran-Mantel-Haenszel|||Any intubation procedure in first 72 hours of life.||8.2|-39.6|0.220
72397313|NCT02772081|144300721|SUPERIORITY||Adjusted difference|4.9||||0.741|TWO_SIDED|95.0|-22.8|32.5|||Cochran-Mantel-Haenszel|||Any intubation procedure within 36 weeks PMA.||32.5|-22.8|0.741
72471693|NCT00474526|144466780|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA1A over LA1B, the lower limit of the two-sided 95% CI for the difference in rates (PLA1A - PLA1B) had to be greater than -10%.|Percentage difference|-3.0|||||TWO_SIDED|95.0|-10.9|4.3|||ANOVA|||PnC 9V (percentage difference (LA1A - LA1B))||4.3|-10.9|
72506081|NCT02385123|144543842|OTHER|A single group analysis was used to determine this outcome measure.|||||||||||||||||A single group analysis was used to determine this outcome measure. These are basic science, hypothesis-generating studies with limited numbers of participants and no control group. The outcomes have no comparisons built into them - the outcomes are stating what the cell counts are, what the antibody titers are, what percentage of people seroconverted, etc. As such, we cannot report any p-values etc. for comparisons (e.g. with unvaccinated people).|||
72397314|NCT02772081|144300722|SUPERIORITY||Median Difference (Final Values)|-8.0||||0.333|TWO_SIDED|95.0|-32.3|16.3|||Wilcoxon (Mann-Whitney)|||Duration of invasive MV in first 28 days PNA.||16.3|-32.3|0.333
72397315|NCT02772081|144300722|SUPERIORITY||Median Difference (Final Values)|-8.0||||0.334|TWO_SIDED|95.0|-49.5|33.5|||Wilcoxon (Mann-Whitney)|||Duration of invasive MV within 36 weeks PMA.||33.5|-49.5|0.334
72397316|NCT02772081|144300723|SUPERIORITY||Adjusted difference|-28.6||||0.596|TWO_SIDED|95.0|-120.9|63.6|||Wilcoxon (Mann-Whitney)|||Duration of invasive mechanical ventilation.||63.6|-120.9|0.596
72506082|NCT02385123|144543843|OTHER|A single group analysis was used to determine this outcome measure.|||||||||||||||||A single group analysis was used to determine this outcome measure. These are basic science, hypothesis-generating studies with limited numbers of participants and no control group. The outcomes have no comparisons built into them - the outcomes are stating what the cell counts are, what the antibody titers are, what percentage of people seroconverted, etc. As such, we cannot report any p-values etc. for comparisons (e.g. with unvaccinated people|||
72565738|NCT02709486|144662695|SUPERIORITY||Odds Ratio (OR)|2.04||||0.0089|TWO_SIDED|95.0|1.2|3.49|||Regression, Logistic|||Week 8: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline patient global assessment of osteoarthritis scale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.49|1.20|0.0089
72397317|NCT02772081|144300724|SUPERIORITY||CMH adjusted difference|-18.6||||0.219|TWO_SIDED|95.0|-47.0|9.8||The percentage of neonates needing invasive MV in the first 72 hours of life, was compared between the treatment groups using the Cochran-Mantel-Haenszel (CMH) test, adjusted for gestational age (GA) group.|Cochran-Mantel-Haenszel|||Invasive MV in the first 72 hours of life.||9.8|-47.0|0.219
72397318|NCT02772081|144300724|SUPERIORITY||Adjusted difference|-3.4||||0.826|TWO_SIDED|95.0|-33.5|26.7|||Cochran-Mantel-Haenszel|||Invasive MV in first 28 days PNA||26.7|-33.5|0.826
72397319|NCT02772081|144300724|SUPERIORITY||Adjusted difference|-3.4||||0.826|TWO_SIDED|95.0|-33.5|26.7|||Cochran-Mantel-Haenszel|||Invasive MV within 36 weeks PMA.||26.7|-33.5|0.826
72397320|NCT03227029|144300751|OTHER||% vaccine recipients with solicited AEs|64.0|||||TWO_SIDED|90.0|46.0|80.0|||||Proportions of study participants were calculated and presented with 90% exact confidence intervals. This highlights that we are 95% sure that the true proportion is not higher that the upper limit of the confidence interval.|||80|46|
72397321|NCT03227029|144300751|OTHER||% vaccine recipients with solicited AEs|84.0|||||TWO_SIDED|90.0|67.0|94.0||||||||94|67|
72397322|NCT03227029|144300751|OTHER||% placebo recipients with solicited AEs|58.0|||||TWO_SIDED|90.0|32.0|82.0||||||||82|32|
72397323|NCT03227029|144300752|OTHER||% vaccine recipients with usolicited AEs|36.0|||||TWO_SIDED|90.0|20.0|54.0||||||||54|20|
72397324|NCT03227029|144300752|OTHER||% vaccine recipients with usolicited AEs|52.0|||||TWO_SIDED|90.0|34.0|69.0||||||||69|34|
72397325|NCT03227029|144300752|OTHER||% placebo recipients with usolicited AEs|42.0|||||TWO_SIDED|90.0|18.0|68.0||||||||68|18|
72397326|NCT03227029|144300754|OTHER||% recipients infected with vaccine virus|88.0|||||TWO_SIDED|90.0|72.0|97.0||||||||97|72|
72397327|NCT03227029|144300754|OTHER||% recipients infected with vaccine virus|96.0|||||TWO_SIDED|90.0|82.0|100.0||||||||100|82|
72471694|NCT00474526|144466780|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA1A over LA1B, the lower limit of the two-sided 95% CI for the difference in rates (PLA1A - PLA1B) had to be greater than -10%.|Percentage difference|-1.0|||||TWO_SIDED|95.0|-5.6|2.7|||ANOVA|||PnC 14 (percentage difference (LA1A - LA1B))||2.7|-5.6|
72471695|NCT00474526|144466780|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA1A over LA1B, the lower limit of the two-sided 95% CI for the difference in rates (PLA1A - PLA1B) had to be greater than -10%.|Percentage difference|-14.0|||||TWO_SIDED|95.0|-24.1|-5.6|||ANOVA|||PnC 18C (percentage difference (LA1A - LA1B))||-5.6|-24.1|
72397328|NCT03227029|144300754|OTHER||% recipients infected with vaccine virus|0.0|||||TWO_SIDED|90.0|0.0|22.0||||||||22|0|
72397329|NCT03227029|144300757|OTHER||% with >=4 fold rise in RSV-PRNT|60.0|||||TWO_SIDED|90.0|42.0|76.0||||||||76|42|
72397330|NCT03227029|144300757|OTHER||% with >=4 fold rise in RSV-PRNT|92.0|||||TWO_SIDED|90.0|76.0|98.0||||||||98|76|
72397331|NCT03227029|144300757|OTHER||% with >=4 fold rise in RSV-PRNT|0.0|||||TWO_SIDED|90.0|0.0|22.0||||||||22|0|
72397332|NCT03227029|144300757|SUPERIORITY||||||<|0.01||||||Due to unequal sample sizes, a 1-sided Fisher's exact test was used to test the hypothesis that proportions of greater than or equal to 4-fold rises were higher in the vaccinated than in the placebo group. Statistical significance level was 0.05.|Fisher Exact|||||||<0.01
72397333|NCT03227029|144300757|SUPERIORITY||||||<|0.01||||||Due to unequal sample sizes, a 1-sided Fisher's exact test was used to test the hypothesis that proportions of greater than or equal to 4-fold rises were higher in the vaccinated than in the placebo group. Statistical significance level was 0.05.|Fisher Exact|||||||<0.01
72397334|NCT03227029|144300758|SUPERIORITY||||||<|0.01||||||Due to unequal sample sizes, a 1-sided Wilcoxon test was used to test the hypothesis that antibody levels at Day 56 were higher in the vaccinated than in the placebo group. Statistical significance level was 0.05.|Wilcoxon (Mann-Whitney)|||||||<0.01
72397335|NCT03227029|144300758|SUPERIORITY||||||<|0.01||||||Due to unequal sample sizes, a 1-sided Wilcoxon test was used to test the hypothesis that antibody levels at Day 56 were higher in the vaccinated than in the placebo group. Statistical significance level was 0.05.|Wilcoxon (Mann-Whitney)|||||||<0.01
72506083|NCT02385123|144543844|OTHER|A single group analysis was used to determine this outcome measure.|||||||||||||||||A single group analysis was used to determine this outcome measure. These are basic science, hypothesis-generating studies with limited numbers of participants and no control group. The outcomes have no comparisons built into them - the outcomes are stating what the cell counts are, what the antibody titers are, what percentage of people seroconverted, etc. As such, we cannot report any p-values etc. for comparisons (e.g. with unvaccinated people).|||
72397336|NCT03227029|144300759|OTHER||% with >=4 fold rise in RSV F protein|60.0|||||TWO_SIDED|90.0|42.0|76.0||||||||76|42|
72506084|NCT02385123|144543845|OTHER|A single group analysis was used to determine this outcome measure.|||||||||||||||||A single group analysis was used to determine this outcome measure. These are basic science, hypothesis-generating studies with limited numbers of participants and no control group. The outcomes have no comparisons built into them - the outcomes are stating what the cell counts are, what the antibody titers are, what percentage of people seroconverted, etc. As such, we cannot report any p-values etc. for comparisons (e.g. with unvaccinated people).|||
72397337|NCT03227029|144300759|OTHER||% with >=4 fold rise in RSV F protein|92.0|||||TWO_SIDED|90.0|76.0|98.0||||||||98|76|
72397338|NCT03227029|144300759|OTHER||% with >=4 fold rise in RSV F protein|0.0|||||TWO_SIDED|90.0|0.0|22.0||||||||22|0|
72506085|NCT02385123|144543846|OTHER|A single group analysis was used to determine this outcome measure.|||||||||||||||||A single group analysis was used to determine this outcome measure. These are basic science, hypothesis-generating studies with limited numbers of participants and no control group. The outcomes have no comparisons built into them - the outcomes are stating what the cell counts are, what the antibody titers are, what percentage of people seroconverted, etc. As such, we cannot report any p-values etc. for comparisons (e.g. with unvaccinated people).|||
72397339|NCT03227029|144300759|SUPERIORITY||||||<|0.01||||||Due to unequal sample sizes, a 1-sided Fisher's exact test was used to test the hypothesis that proportions of greater than or equal to 4-fold rises were higher in the vaccinated than in the placebo group. Statistical significance level was 0.05.|Fisher Exact|||||||<0.01
72397340|NCT03227029|144300759|SUPERIORITY||||||<|0.01||||||Due to unequal sample sizes, a 1-sided Fisher's exact test was used to test the hypothesis that proportions of greater than or equal to 4-fold rises were higher in the vaccinated than in the placebo group. Statistical significance level was 0.05.|Fisher Exact|||||||<0.01
72397341|NCT03227029|144300760|SUPERIORITY||||||<|0.01||||||Due to unequal sample sizes, a 1-sided Wilcoxon test was used to test the hypothesis that antibody levels at Day 56 were higher in the vaccinated than in the placebo group. Statistical significance level was 0.05.|Wilcoxon (Mann-Whitney)|||||||<0.01
72397342|NCT03227029|144300760|SUPERIORITY||||||<|0.01||||||Due to unequal sample sizes, a 1-sided Wilcoxon test was used to test the hypothesis that antibody levels at Day 56 were higher in the vaccinated than in the placebo group. Statistical significance level was 0.05.|Wilcoxon (Mann-Whitney)|||||||<0.01
72397343|NCT01949051|144300787|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.35|||<|0.0001|TWO_SIDED|95.0|-1.943|-0.756|||Mixed Model ANOVA|||||-0.756|-1.943|<0.0001
72397344|NCT01949051|144300787|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.118||||0.0003|TWO_SIDED|95.0|-1.712|-0.525|||Mixed Model ANOVA|||||-0.525|-1.712|0.0003
72397345|NCT01949051|144300787|NON_INFERIORITY_OR_EQUIVALENCE|Levocabastine OD would be declared as non-inferior to levocabastine BID if upper limit of 95% confidence interval of the treatment difference estimate (OD vs BD) was less than 1|Mean Difference (Final Values)|0.231|||||TWO_SIDED|95.0|-0.361|0.823||||||||0.823|-0.361|
72397346|NCT00923598|144300905|EQUIVALENCE|A method by Armitage et al was used, where by equivalence of treatments would be concluded if the 95% CI for the difference fell within the prespecified tolerated interval. Under these assumptions, a trial with 36 subjects (72 limbs) would correctly conclude there is no treatment difference with probability 80%, and incorrectly conclude equivalence when there is a difference of 20% with probability 5%.|Mean Difference (Final Values)|3.0||||0.05|TWO_SIDED|95.0|-10.0|17.0|||Fisher Exact|||||17|-10|0.05
72397347|NCT00828347|144300913|SUPERIORITY_OR_OTHER|||||||0.036|TWO_SIDED||||||Fisher Exact|||||||0.036
72397348|NCT01129960|144300914|SUPERIORITY_OR_OTHER|||||||0.3726|||||||Dunnett's test (analysis of covariance)|||||||0.3726
72397349|NCT01129960|144300914|SUPERIORITY_OR_OTHER|||||||0.8034|||||||Dunnett's test (analysis of covariance)|||||||0.8034
72397350|NCT01129960|144300914|SUPERIORITY_OR_OTHER|||||||0.1391|||||||Dunnett's test (analysis of covariance)|||||||0.1391
72397351|NCT02622321|144300923|SUPERIORITY_OR_OTHER_LEGACY||ABR Ratio|0.13|||<|0.0001|TWO_SIDED|95.0|0.057|0.277||Statistical significance was controlled at a two-sided alpha level of 0.05 based on a Wald testing procedure.|Stratified Wald Test|||Analysis was performed using an NB regression model, which accounted for different follow-up times, with the participant's number of bleeds as a function of randomization and the time that each participant stays in the study included as an offset in the model. The model also included the number of bleeds (less than \[\<\] 9 or greater than or equal to \[\>/=\] 9) in the last 24 weeks prior to study entry as a stratification factor in the randomization.||0.277|0.057|<0.0001
72506086|NCT02385123|144543847|OTHER|||||||||||||||||A single group analysis was used to determine this outcome measure.|A single group analysis was used to determine this outcome measure. These are basic science, hypothesis-generating studies with limited numbers of participants and no control group. The outcomes have no comparisons built into them - the outcomes are stating what the cell counts are, what the antibody titers are, what percentage of people seroconverted, etc. As such, we cannot report any p-values etc. for comparisons (e.g. with unvaccinated people).|||
72506087|NCT02385123|144543848|OTHER|A single group analysis was used to determine this outcome measure.|||||||||||||||||A single group analysis was used to determine this outcome measure. These are basic science, hypothesis-generating studies with limited numbers of participants and no control group. The outcomes have no comparisons built into them - the outcomes are stating what the cell counts are, what the antibody titers are, what percentage of people seroconverted, etc. As such, we cannot report any p-values etc. for comparisons (e.g. with unvaccinated people).|||
72506088|NCT02385123|144543849|OTHER|A single group analysis was used to determine this outcome measure.|||||||||||||||||A single group analysis was used to determine this outcome measure. These are basic science, hypothesis-generating studies with limited numbers of participants and no control group. The outcomes have no comparisons built into them - the outcomes are stating what the cell counts are, what the antibody titers are, what percentage of people seroconverted, etc. As such, we cannot report any p-values etc. for comparisons (e.g. with unvaccinated people).|||
72506089|NCT02385123|144543850|OTHER|A single group analysis was used to determine this outcome measure.|||||||||||||||||A single group analysis was used to determine this outcome measure. These are basic science, hypothesis-generating studies with limited numbers of participants and no control group. The outcomes have no comparisons built into them - the outcomes are stating what the cell counts are, what the antibody titers are, what percentage of people seroconverted, etc. As such, we cannot report any p-values etc. for comparisons (e.g. with unvaccinated people).|||
72506090|NCT02385123|144543851|OTHER|A single group analysis was used to determine this outcome measure.|||||||||||||||||A single group analysis was used to determine this outcome measure. These are basic science, hypothesis-generating studies with limited numbers of participants and no control group. The outcomes have no comparisons built into them - the outcomes are stating what the cell counts are, what the antibody titers are, what percentage of people seroconverted, etc. As such, we cannot report any p-values etc. for comparisons (e.g. with unvaccinated people).|||
72506091|NCT02385123|144543852|OTHER|A single group analysis was used to determine this outcome measure.|||||||||||||||||A single group analysis was used to determine this outcome measure. These are basic science, hypothesis-generating studies with limited numbers of participants and no control group. The outcomes have no comparisons built into them - the outcomes are stating what the cell counts are, what the antibody titers are, what percentage of people seroconverted, etc. As such, we cannot report any p-values etc. for comparisons (e.g. with unvaccinated people).|||
72506092|NCT02385123|144543853|OTHER|A single group analysis was used to determine this outcome measure.|||||||||||||||||A single group analysis was used to determine this outcome measure. These are basic science, hypothesis-generating studies with limited numbers of participants and no control group. The outcomes have no comparisons built into them - the outcomes are stating what the cell counts are, what the antibody titers are, what percentage of people seroconverted, etc. As such, we cannot report any p-values etc. for comparisons (e.g. with unvaccinated people).|||
72397352|NCT02622321|144300924|SUPERIORITY_OR_OTHER_LEGACY||ABR Ratio|0.2|||<|0.0001|TWO_SIDED|95.0|0.102|0.375||Statistical significance was controlled at a two-sided alpha level of 0.05 based on a Wald testing procedure.|Stratified Wald Test|||Analysis was performed using an NB regression model, which accounted for different follow-up times, with the participant's number of bleeds as a function of randomization and the time that each participant stays in the study included as an offset in the model. The model also included the number of bleeds (\<9 or \>/=9) in the last 24 weeks prior to study entry as a stratification factor in the randomization.||0.375|0.102|<0.0001
72397353|NCT02622321|144300925|SUPERIORITY_OR_OTHER_LEGACY||ABR Ratio|0.11|||<|0.0001|TWO_SIDED|95.0|0.055|0.218||Statistical significance was controlled at a two-sided alpha level of 0.05 based on a Wald testing procedure.|Non-Stratified Wald Test|||This intra-participant comparison of ABR for all bleeds was performed using an NB regression model.||0.218|0.055|<0.0001
72397354|NCT02622321|144300926|SUPERIORITY_OR_OTHER_LEGACY||ABR Ratio|0.08|||<|0.0001|TWO_SIDED|95.0|0.031|0.198||Statistical significance was controlled at a two-sided alpha level of 0.05 based on a Wald testing procedure.|Non-Stratified Wald Test|||This intra-participant comparison of ABR for treated bleeds was performed using an NB regression model.||0.198|0.031|<0.0001
72397355|NCT02622321|144300927|SUPERIORITY_OR_OTHER_LEGACY||ABR Ratio|0.11||||0.005|TWO_SIDED|95.0|0.025|0.52||Statistical significance was controlled at a two-sided alpha level of 0.05 based on a Wald testing procedure.|Stratified Wald Test|||Analysis was performed using an NB regression model, which accounted for different follow-up times, with the participant's number of bleeds as a function of randomization and the time that each participant stays in the study included as an offset in the model. The model also included the number of bleeds (\<9 or \>/=9) in the last 24 weeks prior to study entry as a stratification factor in the randomization.||0.520|0.025|0.0050
72397356|NCT02622321|144300928|SUPERIORITY_OR_OTHER_LEGACY||ABR Ratio|0.23|||<|0.0001|TWO_SIDED|95.0|0.119|0.435||Statistical significance was controlled at a two-sided alpha level of 0.05 based on a Wald testing procedure.|Non-Stratified Wald Test|||This intra-participant comparison of ABR for all bleeds was performed using an NB regression model.||0.435|0.119|<0.0001
72565739|NCT02709486|144662695|SUPERIORITY||Odds Ratio (OR)|2.41||||0.0012|TWO_SIDED|95.0|1.42|4.1|||Regression, Logistic|||Week 8: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline patient global assessment of osteoarthritis scale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||4.10|1.42|0.0012
72565740|NCT02709486|144662695|SUPERIORITY||Odds Ratio (OR)|2.4||||0.0006|TWO_SIDED|95.0|1.45|3.98|||Regression, Logistic|||Week 12: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline patient global assessment of osteoarthritis scale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.98|1.45|0.0006
72397357|NCT02622321|144300929|SUPERIORITY_OR_OTHER_LEGACY||ABR Ratio|0.21||||0.0003|TWO_SIDED|95.0|0.089|0.486||Statistical significance was controlled at a two-sided alpha level of 0.05 based on a Wald testing procedure.|Non-Stratified Wald Test|||This intra-participant comparison of ABR for treated bleeds was performed using an NB regression model.||0.486|0.089|0.0003
72397358|NCT02622321|144300930|SUPERIORITY_OR_OTHER_LEGACY||ABR Ratio|0.08|||<|0.0001|TWO_SIDED|95.0|0.037|0.154||Statistical significance was controlled at a two-sided alpha level of 0.05 based on a Wald testing procedure.|Stratified Wald Test|||Analysis was performed using an NB regression model, which accounted for different follow-up times, with the participant's number of bleeds as a function of randomization and the time that each participant stays in the study included as an offset in the model. The model also included the number of bleeds (\<9 or \>/=9) in the last 24 weeks prior to study entry as a stratification factor in the randomization.||0.154|0.037|<0.0001
72397359|NCT02622321|144300931|SUPERIORITY_OR_OTHER_LEGACY||ABR Ratio|0.05||||0.0002|TWO_SIDED|95.0|0.009|0.227||Statistical significance was controlled at a two-sided alpha level of 0.05 based on a Wald testing procedure.|Stratified Wald Test|||Analysis was performed using an NB regression model, which accounted for different follow-up times, with the participant's number of bleeds as a function of randomization and the time that each participant stays in the study included as an offset in the model. The model also included the number of bleeds (\<9 or \>/=9) in the last 24 weeks prior to study entry as a stratification factor in the randomization.||0.227|0.009|0.0002
72565741|NCT02709486|144662695|SUPERIORITY||Odds Ratio (OR)|3.16|||<|0.0001|TWO_SIDED|95.0|1.92|5.21|||Regression, Logistic|||Week 12: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline patient global assessment of osteoarthritis scale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||5.21|1.92|<.0001
72565742|NCT02709486|144662695|SUPERIORITY||Odds Ratio (OR)|1.83||||0.0203|TWO_SIDED|95.0|1.1|3.06|||Regression, Logistic|||Week 16: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline patient global assessment of osteoarthritis scale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.06|1.10|0.0203
72565743|NCT02709486|144662695|SUPERIORITY||Odds Ratio (OR)|2.94|||<|0.0001|TWO_SIDED|95.0|1.77|4.86|||Regression, Logistic|||Week 16: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline patient global assessment of osteoarthritis scale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||4.86|1.77|<.0001
72565744|NCT02709486|144662695|SUPERIORITY||Odds Ratio (OR)|1.56||||0.0775|TWO_SIDED|95.0|0.95|2.55|||Regression, Logistic|||Week 24: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline patient global assessment of osteoarthritis scale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.55|0.95|0.0775
72565745|NCT02709486|144662695|SUPERIORITY||Odds Ratio (OR)|1.97||||0.0064|TWO_SIDED|95.0|1.21|3.21|||Regression, Logistic|||Week 24: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline patient global assessment of osteoarthritis scale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.21|1.21|0.0064
72471696|NCT00474526|144466780|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA1A over LA1B, the lower limit of the two-sided 95% CI for the difference in rates (PLA1A - PLA1B) had to be greater than -10%.|Percentage difference|-3.0|||||TWO_SIDED|95.0|-11.6|5.2|||ANOVA|||PnC 19F (percentage difference (LA1A - LA1B))||5.2|-11.6|
72471697|NCT00474526|144466780|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA1A over LA1B, the lower limit of the two-sided 95% CI for the difference in rates (PLA1A - PLA1B) had to be greater than -10%.|Percentage difference|0.0|||||TWO_SIDED|95.0|-7.0|7.0|||ANOVA|||PnC 23F (percentage difference (LA1A - LA1B))||7|-7|
72471698|NCT00474526|144466781|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA3A over LA3B, the lower limit of the two-sided 95% CI for the ratio of GMCs (GMCLA3A/GMCLA3B) had to be greater than 0.67 for PT, FHA and pertactin and greater than 0.50 for Hib, diphtheria and tetanus.|Ratio of GMCs|1.05|||||TWO_SIDED|95.0|0.86|1.27|||ANOVA|||Diphtheria (Post-vaccination GMC; group ratio LA3A:LA3B)||1.27|0.86|
72471699|NCT00474526|144466781|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA3A over LA3B, the lower limit of the two-sided 95% CI for the ratio of GMCs (GMCLA3A / GMCLA3B) had to be greater than 0.67 for PT, FHA and pertactin and greater than 0.50 for Hib, diphtheria and tetanus.|Ratio of GMCs|0.94|||||TWO_SIDED|95.0|0.75|1.18|||ANOVA|||Tetanus (Post-vaccination GMC; group ratio LA3A:LA3B)||1.18|0.75|
72471700|NCT00474526|144466781|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA3A over LA3B, the lower limit of the two-sided 95% CI for the ratio of GMCs (GMCLA3A / GMCLA3B) had to be greater than 0.67 for PT, FHA and pertactin and greater than 0.50 for Hib, diphtheria and tetanus.|Ratio of GMCs|1.11|||||TWO_SIDED|95.0|0.88|1.4|||ANOVA|||PT (Post-vaccination GMC; group ratio LA3A:LA3B)||1.4|0.88|
72471701|NCT00474526|144466781|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA3A over LA3B, the lower limit of the two-sided 95% CI for the ratio of GMCs (GMCLA3A / GMCLA3B) had to be greater than 0.67 for PT, FHA and pertactin and greater than 0.50 for Hib, diphtheria and tetanus.|Ratio of GMCs|1.14|||||TWO_SIDED|95.0|0.9|1.44|||ANOVA|||FHA (Post-vaccination GMC; group ratio LA3A:LA3B)||1.44|0.9|
72471702|NCT00474526|144466781|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA3A over LA3B, the lower limit of the two-sided 95% CI for the ratio of GMCs (GMCLA3A / GMCLA3B) had to be greater than 0.67 for PT, FHA and pertactin and greater than 0.50 for Hib, diphtheria and tetanus.|Ratio of GMCs|1.21|||||TWO_SIDED|95.0|0.92|1.59|||ANOVA|||Pertactin (Post-vaccination GMC; group ratio LA3A:LA3B||1.59|0.92|
72471703|NCT00474526|144466781|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA3A over LA3B, the lower limit of the two-sided 95% CI for the ratio of GMCs (GMCLA3A / GMCLA3B) had to be greater than 0.67 for PT, FHA and pertactin and greater than 0.50 for Hib, diphtheria and tetanus.|Ratio of GMCs|0.86|||||TWO_SIDED|95.0|0.63|1.16|||ANOVA|||Hib (Post-vaccination GMC; group ratio LA3A:LA3B)||1.16|0.63|
72471704|NCT00474526|144466782|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA3A over LA3B, The lower limit of the two-sided 95% CI for the difference (PLA3A-PLA3B) in percentages of subjects with seroresponse against diphtheria, tetanus, Hib and pertussis antigens (except FHA for ≥4 fold rise) was greater than -10%|Percentage difference|0.0||||||95.0|-4.2|5.4|||ANOVA|||Diphtheria (percentage difference (LA3A - LA3B))||5.4|-4.2|
72471705|NCT00474526|144466782|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA3A over LA3B, The lower limit of the two-sided 95% CI for the difference (PLA3A-PLA3B) in percentages of subjects with seroresponse against diphtheria, tetanus, Hib and pertussis antigens (except FHA for ≥4 fold rise) was greater than -10%|Percentage difference|0.0|||||TWO_SIDED|95.0|-4.2|5.4|||ANOVA|||Tetanus (percentage difference (LA3A - LA3B))||5.4|-4.2|
72397360|NCT02622321|144300935|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Mean Difference|21.55||||0.0029|TWO_SIDED|95.0|7.89|35.22||Statistical significance was controlled at a two-sided alpha level of 0.05.|ANCOVA|||Actual number of participants included for inferential statistics in Arm A is 25. Means adjusted for covariates: baseline score, treatment group and treatment by baseline interaction arm. Analysis was performed using Analysis of Covariance (ANCOVA).||35.22|7.89|0.0029
72397361|NCT02622321|144300936|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Mean Difference|14.01||||0.0019|TWO_SIDED|95.0|5.56|22.45||Statistical significance was controlled at a two-sided alpha level of 0.05.|ANCOVA|||Actual number of participants included for inferential statistics in Arm A is 25. Means adjusted for covariates: baseline score, treatment group and treatment by baseline interaction arm.||22.45|5.56|0.0019
72397362|NCT02622321|144300937|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Mean Difference|-9.72||||0.0171|TWO_SIDED|95.0|-17.62|-1.82||Statistical significance was controlled at a two-sided alpha level of 0.05.|ANCOVA|||Actual number of participants included for inferential statistics in Arm A is 29. Means adjusted for covariates: baseline score, treatment group and treatment by baseline interaction arm.||-1.82|-17.62|0.0171
72506093|NCT02385123|144543855|OTHER|A single group analysis was used to determine this outcome measure.|||||||||||||||||These are basic science, hypothesis-generating studies with limited numbers of participants and no control group. The outcomes have no comparisons built into them - the outcomes are stating what the cell counts are, what the antibody titers are, what percentage of people seroconverted, etc. As such, we cannot report any p-values etc. for comparisons (e.g. with unvaccinated people).|||
72506094|NCT02385123|144543856|OTHER|A single group analysis was used to determine this outcome measure.|||||||||||||||||These are basic science, hypothesis-generating studies with limited numbers of participants and no control group. The outcomes have no comparisons built into them - the outcomes are stating what the cell counts are, what the antibody titers are, what percentage of people seroconverted, etc. As such, we cannot report any p-values etc. for comparisons (e.g. with unvaccinated people).|||
72506095|NCT02385123|144543857|OTHER|Single group analysis.|||||||||||||||||A single group analysis was used to determine this outcome measure. These are basic science, hypothesis-generating studies with limited numbers of participants and no control group. The outcomes have no comparisons built into them - the outcomes are stating what the cell counts are, what the antibody titers are, what percentage of people seroconverted, etc. As such, we cannot report any p-values etc. for comparisons (e.g. with unvaccinated people).|||
72506096|NCT02385123|144543858|OTHER|A single group analysis was used to determine this outcome measure.|||||||||||||||||A single group analysis was used to determine this outcome measure. These are basic science, hypothesis-generating studies with limited numbers of participants and no control group. The outcomes have no comparisons built into them - the outcomes are stating what the cell counts are, what the antibody titers are, what percentage of people seroconverted, etc. As such, we cannot report any p-values etc. for comparisons (e.g. with unvaccinated people).|||
72506097|NCT02385123|144543859|OTHER|A single group analysis was used to determine this outcome measure.|||||||||||||||||A single group analysis was used to determine this outcome measure. These are basic science, hypothesis-generating studies with limited numbers of participants and no control group. The outcomes have no comparisons built into them - the outcomes are stating what the cell counts are, what the antibody titers are, what percentage of people seroconverted, etc. As such, we cannot report any p-values etc. for comparisons (e.g. with unvaccinated people).|||
72565746|NCT02709486|144662696|SUPERIORITY||Least Square Mean Difference|-0.49|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001|TWO_SIDED|95.0|-0.7|-0.27|||ANCOVA|||Week 1: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.||-0.27|-0.70|<.0001
72565747|NCT02709486|144662696|SUPERIORITY||Least Square Mean Difference|-0.36|STANDARD_ERROR_OF_MEAN|0.11||0.0009|TWO_SIDED|95.0|-0.58|-0.15|||ANCOVA|||Week 1: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.||-0.15|-0.58|0.0009
72565748|NCT02709486|144662696|SUPERIORITY||Least Square Mean Difference|-0.74|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-1.0|-0.48|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.||-0.48|-1.00|<.0001
72622936|NCT03926247|144776095|OTHER|Within-group longitudinal analysis (no comparison groups)|Mean Difference (Final Values)|-0.216|STANDARD_ERROR_OF_MEAN|0.124|=|0.086|TWO_SIDED|95.0|-0.461|0.03|||Mixed Models Analysis|||Analyses were conducted using a mixed effects linear model to calculate least square means across the 4 timepoints. This was a longitudinal within-group analysis with 4 timepoints of data nested within 56 individuals. Our hypothesis was that participants' quality of life would increase overtime.||0.030|-0.461|=0.086
72622937|NCT00773461|144776112|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
72397363|NCT02622321|144300938|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Mean Difference|-0.16||||0.0014|TWO_SIDED|95.0|-0.25|-0.07||Statistical significance was controlled at a two-sided alpha level of 0.05.|ANCOVA|||Actual number of participants included for inferential statistics in Arm A is 29. Means adjusted for covariates: baseline score, treatment group and treatment by baseline interaction arm.||-0.07|-0.25|0.0014
72622938|NCT00773461|144776112|SUPERIORITY_OR_OTHER||||||<|0.0001||||||ITT Population (Sensitivity)|Cochran-Mantel-Haenszel|||||||<0.0001
72397364|NCT01958008|144300957|SUPERIORITY_OR_OTHER||Slope|1.2674|STANDARD_ERROR_OF_MEAN|0.1019|||TWO_SIDED|95.0|1.0636|1.4713|||Regression, Linear|Power model that describes the functional relationship between the dose and pharmacokinetic endpoint Cmax,ss||Dose proportionality was analysed over the dose range 10 to 50 mg for plasma PK parameters based on a power model||1.4713|1.0636|
72506098|NCT02385123|144543860|OTHER|A single group analysis was used to determine this outcome measure.|||||||||||||||||A single group analysis was used to determine this outcome measure. These are basic science, hypothesis-generating studies with limited numbers of participants and no control group. The outcomes have no comparisons built into them - the outcomes are stating what the cell counts are, what the antibody titers are, what percentage of people seroconverted, etc. As such, we cannot report any p-values etc. for comparisons (e.g. with unvaccinated people).|||
72397365|NCT01958008|144300958|SUPERIORITY_OR_OTHER||Slope|1.2139|STANDARD_ERROR_OF_MEAN|0.081|||TWO_SIDED|95.0|1.0519|1.3759|||Regression, Linear|Power model that describes the functional relationship between the dose and pharmacokinetic endpoint AUC tau,ss||Dose proportionality was analysed over the dose range 10 to 50 mg for plasma PK parameters based on a power model||1.3759|1.0519|
72397366|NCT00965718|144300972|SUPERIORITY_OR_OTHER_LEGACY|||||||0.123||||||Global health status scores at baseline and final observation point were compared via a 2-sided t-test.|t-test, 2 sided|||||||0.123
72397367|NCT02028065|144300979|SUPERIORITY_OR_OTHER||Difference in incidence|5.3|||||TWO_SIDED|95.0|-0.9|10.7|||||Difference is Sugammadex 4 mg/kg incidence minus Placebo incidence. Confidence interval calculated using method of Miettinen and Nurminen (Statistics in Medicine 1985;4:213-226).|Planned sample size of 150 participants in each sugammadex group (4 mg/kg and 16 mg/kg) allowed estimation of adjudicated hypersensitivity in each sugammadex group with a 95% confidence interval with a half-width between 1.2 and 4.2 percentage points. Calculation, based on method of Clopper and Pearson (Biometrika 1934;26\[4\]:404-413), used underlying event rate of up to 6% in the sugammadex high dose group, based on study results from protocol P06042 (NCT00988065).||10.7|-0.9|
72397368|NCT02028065|144300979|SUPERIORITY_OR_OTHER||Difference in incidence|8.1|||||TWO_SIDED|95.0|1.7|14.2|||||Difference is Sugammadex 16 mg/kg incidence minus Placebo incidence. Confidence interval calculated using method of Miettinen and Nurminen(Statistics in Medicine 1985;4:213-226).|Planned sample size of 150 participants in each sugammadex group (4 mg/kg and 16 mg/kg) allowed estimation of adjudicated hypersensitivity in each sugammadex group with a 95% confidence interval with a half-width between 1.2 and 4.2 percentage points. Calculation, based on method of Clopper and Pearson (Biometrika 1934;26\[4\]:404-413), used underlying event rate of up to 6% in the sugammadex high dose group, based on study results from protocol P06042 (NCT00988065).||14.2|1.7|
72397369|NCT02028065|144300980|SUPERIORITY_OR_OTHER||Difference in incidence|0.0|||||TWO_SIDED|95.0|-4.8|2.5|||||Difference is Sugammadex 4 mg/kg incidence minus Placebo incidence. Confidence interval calculated using method of Miettinen and Nurminen (Statistics in Medicine 1985;4:213-226).|||2.5|-4.8|
72397370|NCT02028065|144300980|SUPERIORITY_OR_OTHER||Difference in incidence|0.7|||||TWO_SIDED|95.0|-4.2|3.7|||||Difference is Sugammadex 16 mg/kg incidence minus Placebo incidence. Confidence interval calculated using method of Miettinen and Nurminen (Statistics in Medicine 1985;4:213-226).|||3.7|-4.2|
72397371|NCT00867009|144301018|SUPERIORITY_OR_OTHER||Percentage of participants with response|38.5|||||TWO_SIDED|80.0|32.3|45.09||||||||45.09|32.30|
72397372|NCT00867009|144301019|SUPERIORITY_OR_OTHER||Median number of months|5.82|||||TWO_SIDED|80.0|4.4|6.7||||||||6.70|4.40|
72397373|NCT00867009|144301020|SUPERIORITY_OR_OTHER||Percentage of participants with response|45.0|||||TWO_SIDED|80.0|39.0|51.0||||||||51|39|
72397374|NCT00867009|144301021|SUPERIORITY_OR_OTHER||Percentage of participants with response|59.6|||||TWO_SIDED|80.0|53.06|65.94||||||||65.94|53.06|
72397375|NCT00147199|144301035|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehmann Estimate|20.0||||0.00044|TWO_SIDED|95.0|8.0|32.8|||ANCOVA|Lowest rank was assigned for death, discontinuation due to disease progression, and for patients who initiated additional approved PAH therapy.||Sample size was calculated based on the primary endpoint; change in 6MWD at Week 12. Assuming a between-treatment difference of 35m, a standard deviation of 75m, and a type I (alpha) error of 0.05 (i.e., two-sided p-value of less than 0.05), in order to have 90% power to detect this difference, 100 subjects per treatment group were required for this trial (total n=200). This allowed for a dropout rate of 10% as 110 subjects per group was planned.||32.8|8.0|0.00044
72397376|NCT00147199|144301037|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehmann (H-L)|0.0||||0.623|TWO_SIDED|95.0|-0.5|0.0|||Wilcoxon rank sum test|||||0.0|-0.5|0.623
72397377|NCT00147199|144301038|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehmann (H-L)|0.0||||0.807|TWO_SIDED|95.0|0.0|0.0||Imputation strategies were implemented for 16 inhaled treprostinil subjects and 9 placebo subjects without values reported at Week 12|Wilcoxon rank sum test|||||0.0|0.0|0.807
72471706|NCT00474526|144466782|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA3A over LA3B, The lower limit of the two-sided 95% CI for the difference (PLA3A-PLA3B) in percentages of subjects with seroresponse against diphtheria, tetanus, Hib and pertussis antigens (except FHA for ≥4 fold rise) was greater than -10%|Percentage difference|6.0||||||95.0|-3.6|15.2|||ANOVA|||PT (percentage difference (LA3A - LA3B))||15.2|-3.6|
72622939|NCT00773461|144776113|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Comparison of ACR 50 responders in placebo and Tocilizumab groups|Cochran-Mantel-Haenszel|||||||<0.0001
72397378|NCT00147199|144301039|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehmann (H-L)|13.7||||0.007|TWO_SIDED|95.0|4.0|24.8|||ANCOVA|||||24.8|4.0|0.007
72397379|NCT00147199|144301040|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehmann (H-L)|18.5||||0.0003|TWO_SIDED|95.0|8.5|28.3|||Wilcoxon rank sum test|||||28.3|8.5|0.0003
72397380|NCT00147199|144301041|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehman Estimate|-4.0||||0.027|TWO_SIDED|95.0|-8.0|0.0|||Wilcoxon rank sum test|||Global Score||0|-8.0|0.027
72397381|NCT00147199|144301041|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehman Estimate|-2.0||||0.037|TWO_SIDED|95.0|-3.0|0.0|||Wilcoxon rank sum test|||Physical Dimension||0.0|-3.0|0.037
72397382|NCT00147199|144301041|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehman Estimate|-1.0||||0.173|TWO_SIDED|95.0|-2.0|0.0|||Wilcoxon rank sum test|||Emotional Dimension Score||0.0|-2.0|0.173
72397383|NCT00147199|144301043|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehman Estimate|-167.0||||0.001|TWO_SIDED|95.0|-333.0|-64.0|||Wilcoxon rank sum test|||||-64|-333|0.001
72397384|NCT01850524|144301044|SUPERIORITY||Hazard Ratio (HR)|0.83||||0.073|TWO_SIDED|95.0|0.676|1.018|||Log Rank|Log-rank test is stratified by age (\<75 years vs \>=75), ISS (stage I or II vs stage III), and BPI-SF worst pain score (\<4 vs \>=4) at screening.||||1.018|0.676|0.073
72397385|NCT01850524|144301045|SUPERIORITY||Hazard Ratio (HR)|0.998||||0.988|TWO_SIDED|95.0|0.79|1.261|||Log Rank|Log-rank test is stratified by age (\<75 years vs \>=75), ISS (stage I or II vs stage III), and BPI-SF worst pain score (\<4 vs \>=4) at screening.|Hazard ratio is based on an Unadjusted Cox's proportional hazard regression model is stratified by age (\<75 years vs \>=75), ISS (stage I or II vs stage III), and BPI-SF worst pain score (\<4 vs \>=4) at screening.|||1.261|0.790|0.988
72471707|NCT00474526|144466782|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA3A over LA3B, The lower limit of the two-sided 95% CI for the difference (PLA3A-PLA3B) in percentages of subjects with seroresponse against diphtheria, tetanus, Hib and pertussis antigens (except FHA for ≥4 fold rise) was greater than -10%|Percentage difference|-1.0|||||TWO_SIDED|95.0|-10.2|8.2|||ANOVA|||FHA (percentage difference (LA3A - LA3B))||8.2|-10.2|
72397386|NCT01850524|144301046|SUPERIORITY||Odds Ratio (OR)|2.1|||<|0.001|TWO_SIDED|95.0|1.43|3.09|||Cochran-Mantel-Haenszel|CMH test is stratified by age (\<75 years vs \>=75), ISS (stage I or II vs stage III), and BPI-SF worst pain score (\<4 vs \>=4) at screening.|Odds ratio and confidence interval are based on logistic regression model with treatment group as categorical predictor variable,age(\<75 years vs \>=75), ISS(stage I or II vs stage III),and BPI-SF worst pain score(\<4 vs \>=4)at screening as covariates.|||3.09|1.43|<0.001
72397387|NCT01850524|144301047|SUPERIORITY||Odds Ratio (OR)|0.98||||0.9195|TWO_SIDED|95.0|0.656|1.463|||Regression, Logistic|Logistic regression model with prognostic factor: age (\<75 years vs \>=75) and ISS (stage I or II vs stage III).|Odds ratio \> 1 favors Ixazomib+LenDex versus LenDex alone.|||1.463|0.656|0.9195
72506099|NCT02385123|144543861|OTHER|A single group analysis was used to determine this outcome measure.|||||||||||||||||A single group analysis was used to determine this outcome measure. These are basic science, hypothesis-generating studies with limited numbers of participants and no control group. The outcomes have no comparisons built into them - the outcomes are stating what the cell counts are, what the antibody titers are, what percentage of people seroconverted, etc. As such, we cannot report any p-values etc. for comparisons (e.g. with unvaccinated people).|||
72506100|NCT02345434|144543887|SUPERIORITY||Mean Difference (Final Values)|3.53|||||TWO_SIDED|95.0|-6.35|13.4||||||||13.4|-6.35|
72506101|NCT02345434|144543888|SUPERIORITY||Mean Difference (Final Values)|-0.79|||||TWO_SIDED|95.0|-3.68|2.1||||||||2.1|-3.68|
72506102|NCT02487745|144543945|SUPERIORITY||Odds Ratio (OR)|2.29||||0.05|TWO_SIDED|95.0|||||Regression, Logistic|||||||.05
72506103|NCT02487745|144543946|SUPERIORITY||Odds Ratio (OR)|3.88||||0.05|TWO_SIDED|95.0|||||Regression, Logistic|||||||.05
72506104|NCT01765712|144543965|SUPERIORITY||Mean Difference (Final Values)|0.48||||0.55|TWO_SIDED|95.0|-1.99|1.03|||t-test, 2 sided|||||1.03|-1.99|0.55
72506105|NCT01004107|144543970|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||< 0.0001
72397388|NCT01850524|144301048|SUPERIORITY||Odds Ratio (OR)|1.16||||0.436|TWO_SIDED|95.0|0.79|1.7|||Cochran-Mantel-Haenszel|CMH test is stratified by age (\<75 years vs \>=75), ISS (stage I or II vs stage III), and BPI-SF worst pain score (\<4 vs \>=4) at screening.|Odds ratio and confidence interval are based on logistic regression model with treatment group as categorical predictor variable,age(\<75 years vs \>=75), ISS(stage I or II vs stage III),and BPI-SF worst pain score(\<4 vs \>=4)at screening as covariates.|||1.70|0.79|0.436
72565749|NCT02709486|144662696|SUPERIORITY||Least Square Mean Difference|-0.51|STANDARD_ERROR_OF_MEAN|0.13||0.0001|TWO_SIDED|95.0|-0.77|-0.25|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.||-0.25|-0.77|0.0001
72622940|NCT00773461|144776113|SUPERIORITY_OR_OTHER|||||||0.0345||||||Comparison of ACR 70 responders in placebo and Tocilizumab groups|Cochran-Mantel-Haenszel|||||||0.0345
72506106|NCT01004107|144543971|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Fisher Exact|||||||<0.0001
72506107|NCT01004107|144543972|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Fisher Exact|||||||<0.0001
72506108|NCT01004107|144543973|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
72506109|NCT01004107|144543976|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
72506110|NCT01004107|144543977|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Fisher Exact|||||||<0.0001
72506111|NCT00394914|144543987|SUPERIORITY_OR_OTHER|||||||0.973|||||||Cochran-Mantel-Haenszel|||||||0.973
72506112|NCT00394914|144543988|SUPERIORITY_OR_OTHER|||||||0.425|||||||Cochran-Mantel-Haenszel|||||||0.425
72506113|NCT00872898|144544018|SUPERIORITY_OR_OTHER||Least squares mean difference|-2.2||||0.1197|TWO_SIDED|95.0|-4.9|0.6|||mixed-model for repeated measures|||||0.6|-4.9|0.1197
72506114|NCT00872898|144544019|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.1||||0.9781|TWO_SIDED|95.0|-7.2|7.0|||mixed-model for repeated measures|||||7.0|-7.2|0.9781
72506115|NCT00872898|144544020|SUPERIORITY_OR_OTHER||Least squares mean difference|-1.4||||0.1459|TWO_SIDED|95.0|-3.2|0.5|||mixed-model for repeated measures|||||0.5|-3.2|0.1459
72506116|NCT00872898|144544021|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.8||||0.1344|TWO_SIDED|95.0|-1.9|0.3|||mixed-model for repeated measures|||||0.3|-1.9|0.1344
72506117|NCT00872898|144544022|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.2||||0.7|TWO_SIDED|95.0|-1.5|1.0|||mixed-model for repeated measures|||||1.0|-1.5|0.7000
72506118|NCT00872898|144544023|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.1||||0.9069|TWO_SIDED|95.0|-1.3|1.1|||mixed-model for repeated measures|||||1.1|-1.3|0.9069
72506119|NCT00872898|144544024|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.3||||0.4679|TWO_SIDED|95.0|-1.2|0.6|||mixed-model for repeated measures|||||0.6|-1.2|0.4679
72506120|NCT00872898|144544025|SUPERIORITY_OR_OTHER||Least squares mean difference|0.0||||0.9598|TWO_SIDED|95.0|-1.3|1.3|||mixed-model for repeated measures|||||1.3|-1.3|0.9598
72506121|NCT00872898|144544026|SUPERIORITY_OR_OTHER||Least squares mean difference|0.0||||0.9898|TWO_SIDED|95.0|-1.3|1.3|||mixed-model for repeated measures|||||1.3|-1.3|0.9898
72506122|NCT00872898|144544027|SUPERIORITY_OR_OTHER||Least squares mean difference|0.5||||0.4228|TWO_SIDED|95.0|-0.7|1.6|||mixed-model for repeated measures|||||1.6|-0.7|0.4228
72506123|NCT00872898|144544028|SUPERIORITY_OR_OTHER||Least squares mean difference|1.4||||0.0201|TWO_SIDED|95.0|0.2|2.5|||mixed-model for repeated measures|||||2.5|0.2|0.0201
72506124|NCT00872898|144544029|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.2||||0.6889|TWO_SIDED|95.0|-1.3|0.9|||mixed-model for repeated measures|||||0.9|-1.3|0.6889
72506125|NCT00872898|144544030|SUPERIORITY_OR_OTHER||Least squares mean difference|0.2||||0.7481|TWO_SIDED|95.0|-0.9|1.2|||mixed-model for repeated measures|||||1.2|-0.9|0.7481
72506126|NCT00872898|144544031|SUPERIORITY_OR_OTHER||Least squares mean difference|0.0||||0.95|TWO_SIDED|95.0|-1.2|1.1|||mixed-model for repeated measures|||||1.1|-1.2|0.9500
72506127|NCT00044044|144544034|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0|||||ANCOVA|||||||<0.05
72506128|NCT00044044|144544035|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0|||||ANCOVA|||||||<0.05
72506129|NCT00044044|144544036|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0|||||ANCOVA|||||||<0.05
72506130|NCT00044044|144544037|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0|||||ANCOVA|||||||<0.05
72622941|NCT00773461|144776115|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.7|||<|0.0001|TWO_SIDED|95.0|-6.6|-2.8||p value was calculated using the difference between core set values of the two arms.|ANCOVA|||Placebo + DMARDs Vs Tocilizumab + DMARDs analysis for Swollen Joint Count||-2.8|-6.6|<0.0001
72397389|NCT01850524|144301049|SUPERIORITY||Hazard Ratio (HR)|1.402|||<|0.001|TWO_SIDED|95.0|1.185|1.659|||Log Rank|Log-rank test is stratified by age (\<75 years vs \>=75), ISS (stage I or II vs stage III), and BPI-SF worst pain score (\<4 vs \>=4) at screening.|Hazard ratio is based on an unadjusted Cox's proportional hazard regression model stratified by age (\<75 years vs \>=75), ISS (stage I or II vs stage III), and BPI-SF worst pain score (\<4 vs \>=4) at screening.|||1.659|1.185|<0.001
72397390|NCT01850524|144301051|SUPERIORITY||Hazard Ratio (HR)|0.738||||0.008|TWO_SIDED|95.0|0.589|0.925|||Log Rank|Log-rank test is stratified by age (\<75 years vs \>=75), ISS (stage I or II vs stage III), and BPI-SF worst pain score (\<4 vs \>=4) at screening.|Hazard ratio is based on an unadjusted Cox's proportional hazard regression model stratified by age (\<75 years vs \>=75), ISS (stage I or II vs stage III), and BPI-SF worst pain score (\<4 vs \>=4) at screening.|||0.925|0.589|0.008
72471708|NCT00474526|144466782|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA3A over LA3B, The lower limit of the two-sided 95% CI for the difference (PLA3A-PLA3B) in percentages of subjects with seroresponse against diphtheria, tetanus, Hib and pertussis antigens (except FHA for ≥4 fold rise) was greater than -10%|Percentage difference|2.0|||||TWO_SIDED|95.0|-7.2|10.6|||ANOVA|||Pertactin (percentage difference (LA3A - LA3B))||10.6|-7.2|
72471709|NCT00474526|144466782|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA3A over LA3B, The lower limit of the two-sided 95% CI for the difference (PLA3A-PLA3B) in percentages of subjects with seroresponse against diphtheria, tetanus, Hib and pertussis antigens (except FHA for ≥4 fold rise) was greater than -10%|Percentage difference|0.0|||||TWO_SIDED|95.0|-3.1|3.6|||ANOVA|||Hib (≥ 0.15 μg/mL) (percentage difference (LA3A - LA3B))||3.6|-3.1|
72471710|NCT00474526|144466782|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA3A over LA3B, The lower limit of the two-sided 95% CI for the difference (PLA3A-PLA3B) in percentages of subjects with seroresponse against diphtheria, tetanus, Hib and pertussis antigens (except FHA for ≥4 fold rise) was greater than -10%|Percentage difference|1.0|||||TWO_SIDED|95.0|-2.2|5.3|||ANOVA|||Hib (≥1.0 μg/mL) (percentage difference (LA3A - LA3B))||5.3|-2.2|
72471711|NCT01251770|144466791|SUPERIORITY_OR_OTHER|||||||0.03||95.0|||||t-test, 2 sided|||Serum Sodium difference at the beginning||||0.030
72471712|NCT01251770|144466791|SUPERIORITY_OR_OTHER|||||||0.871||95.0|||||t-test, 2 sided|||Serum Sodium at the end of the study||||0.871
72506131|NCT04036136|144544082|EQUIVALENCE|The equivalence margin is 0.|Mean Difference (Final Values)|-0.36||||0.724|TWO_SIDED|95.0|-2.41|1.68|||ANCOVA|||Model covariates are Baseline SHAPS, age, and sex.||1.68|-2.41|0.724
72506132|NCT04036136|144544083|EQUIVALENCE|The equivalence margin is 0.|Mean Difference (Final Values)|-0.043||||0.292|TWO_SIDED|95.0|-0.124|0.038|||Regression, Linear|||Model covariates are Baseline fMRI, age, and sex.||0.038|-0.124|0.292
72506133|NCT04036136|144544084|EQUIVALENCE|The equivalence margin is 0.|Median Difference (Final Values)|-0.148||||0.084|TWO_SIDED|95.0|-0.316|0.02||The equivalence margin is 0.|Regression, Linear|||Model covariates are Baseline fMRI, age, and sex.||0.020|-0.316|0.084
72506134|NCT02961764|144544093|SUPERIORITY||Odds Ratio (OR)|0.289|||<|0.001|TWO_SIDED|95.0|0.156|0.532|||Fisher Exact|||||0.532|0.156|<0.001
72506135|NCT02961764|144544094|SUPERIORITY|||||||0.005|||||||t-test, 1 sided|||||||0.005
72471713|NCT01251770|144466792|SUPERIORITY_OR_OTHER|||||||0.895|TWO_SIDED|95.0|||||t-test, 2 sided|||||||0.895
72471714|NCT04307940|144466793|SUPERIORITY||LS Mean Difference|14.81||||0.001|TWO_SIDED|95.0|6.1|23.51||All p-values were presented using two-sided test with alpha 0.05 and were considered statistically significant.|ANCOVA|||||23.51|6.10|0.001
72471715|NCT04307940|144466793|SUPERIORITY||LS Mean Difference|39.63|||<|0.001|TWO_SIDED|95.0|29.08|50.18||All p-values were presented using two-sided test with alpha 0.05 and were considered statistically significant.|ANCOVA|||||50.18|29.08|<0.001
72471716|NCT04307940|144466793|SUPERIORITY||LS Mean Difference|24.82|||<|0.001|TWO_SIDED|95.0|14.26|35.39||All p-values were presented using two-sided test with alpha 0.05 and were considered statistically significant.|ANCOVA|||||35.39|14.26|<0.001
72471717|NCT04896008|144466823|SUPERIORITY||Hazard Ratio (HR)|0.24|||<|0.0001|TWO_SIDED|95.0|0.13|0.43||One-sided p-value based on log-rank test stratified by the randomization stratification factors (REVEAL Lite 2.0 risk score and PAH subtype).|Log Rank||HR and associated 95% confidence interval were based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by the randomization stratification factors (REVEAL Lite 2.0 risk score and PAH subtype).|||0.43|0.13|<0.0001
72506136|NCT02961764|144544095|SUPERIORITY|||||||0.05|||||||t-test, 1 sided|||||||0.050
72506137|NCT02961764|144544097|SUPERIORITY|||||||0.002|||||||t-test, 1 sided|||||||0.002
72506138|NCT00866294|144544129|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.4|||<|0.001|TWO_SIDED|95.0|-3.8|-1.1||The hypothesis test was conducted with a two-sided significance level of 5% to show the superiority of paroxetine CR relative to placebo.|ANCOVA|The primary analysis was based on an ANCOVA with a model adjusting for baseline HAM-D total score and region (Japan and South Korea).|Mean difference = paroxetine CR minus placebo|||-1.1|-3.8|<0.001
72506139|NCT00916721|144544145|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||Mixed Models Analysis|Multiple significance testing:we adjusted p-value by controlling the expected proportion of falsely rejected hypotheses:false discovery rate,Benjamini||||||0.05
72506140|NCT02101411|144544173|OTHER|The Chi-squared test was used for comparisons of all categorical variables. If 20% of the cells had an expected value \< 5, then Fisher's exact test was used.|Hazard Ratio (HR)|1.19|STANDARD_DEVIATION|0.005||0.002|TWO_SIDED|||||The Chi-squared test was used for comparisons of all categorical variables. If 20% of the cells had an expected value \< 5, then Fisher's exact test was used.|Chi-squared|The differences among the three PRU groups (\<85, 85-208,\>208) and ADEs were compared using the Chi-squared test.||The differences among the three PRU groups (\<85, 85-208,\>208) and MACE rate at 24 months were compared using the Chi-squared test. was recorded.||||0.002
72622942|NCT00773461|144776115|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.7|||<|0.0001|TWO_SIDED|95.0|-11.3|-6.1||p value was calculated using the difference between core set values of the two arms.|ANCOVA|||Placebo + DMARDs Vs Tocilizumab + DMARDs analysis for Tender Joint Count||-6.1|-11.3|<0.0001
72622943|NCT00773461|144776116|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.1|||<|0.0001|TWO_SIDED|95.0|-25.3|-12.9|||ANCOVA|||||-12.9|-25.3|<0.0001
72397391|NCT01850524|144301052|SUPERIORITY||Hazard Ratio (HR)|0.859||||0.189|TWO_SIDED|95.0|0.684|1.078|||Log Rank|Log-rank test is stratified by age (\<75 years vs \>=75), ISS (stage I or II vs stage III), and BPI-SF worst pain score (\<4 vs \>=4) at screening.|Hazard ratio is based on an unadjusted Cox's proportional hazard regression model stratified by age (\<75 years vs \>=75), ISS (stage I or II vs stage III), and BPI-SF worst pain score (\<4 vs \>=4) at screening.|||1.078|0.684|0.189
72397392|NCT01850524|144301058|SUPERIORITY||Hazard Ratio (HR)|1.118||||0.662|TWO_SIDED|95.0|0.678|1.845|||Log Rank|Log-rank test is stratified by age (\<75 years vs \>=75), ISS (stage I or II vs stage III), and BPI-SF worst pain score (\<4 vs \>=4) at screening.|Hazard ratio is based on an unadjusted Cox's proportional hazard regression model stratified by age (\<75 years vs \>=75), ISS (stage I or II vs stage III), and BPI-SF worst pain score (\<4 vs \>=4) at screening.|OS in High-risk Population Carrying Del(17p), Amp(1q21), t(4;14), or t(14;16) Mutations||1.845|0.678|0.662
72397393|NCT01850524|144301059|SUPERIORITY||Hazard Ratio (HR)|0.76||||0.271|TWO_SIDED|95.0|0.466|1.24|||Log Rank|Log-rank test is stratified by age (\<75 years vs \>=75), ISS (stage I or II vs stage III), and BPI-SF worst pain score (\<4 vs \>=4) at screening.|Hazard ratio is based on an unadjusted Cox's proportional hazard regression model stratified by age (\<75 years vs \>=75), ISS (stage I or II vs stage III), and BPI-SF worst pain score (\<4 vs \>=4) at screening.|PFS in High-risk Population Carrying del(17p), t(4;14), or t(14;16) Mutations||1.240|0.466|0.271
72471718|NCT04896008|144466824|SUPERIORITY||Hazard Ratio (HR)|0.42||||0.0313|TWO_SIDED|95.0|0.17|1.07||One-sided p-value based on log-rank test stratified by the randomization stratification factors (REVEAL Lite 2.0 risk score and PAH subtype).|Log Rank||Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by the randomization stratification factors (REVEAL Lite 2.0 risk score and PAH subtype).|||1.07|0.17|0.0313
72471719|NCT04896008|144466825|SUPERIORITY||Hazard Ratio (HR)|0.34||||0.0039|TWO_SIDED|95.0|0.15|0.78||One-sided p-value based on log-rank test stratified by the randomization stratification factors (REVEAL Lite 2.0 risk score and PAH subtype).|Log Rank||Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by the randomization stratification factors (REVEAL Lite 2.0 risk score and PAH subtype).|||0.78|0.15|0.0039
72471720|NCT04896008|144466826|SUPERIORITY||Treatment Difference|-7.29||||0.135|TWO_SIDED|95.0|-17.65|2.41||Two-sided p-value is calculated based on Cochran-Mantel-Haenszel method stratified by the randomization stratification factors (REVEAL Lite 2.0 risk score and PAH subtype).|Cochran-Mantel-Haenszel||Based on Miettinen and Nurminen method stratified by the randomization stratification factors (REVEAL Lite 2.0 risk score and PAH subtype)|||2.41|-17.65|0.135
72471721|NCT04896008|144466827|SUPERIORITY||Treatment Difference|-3.1|||<|0.001|TWO_SIDED|95.0|-4.25|-1.88||Two-sided p-value is provided using aligned rank stratified Wilcoxon test stratified by a randomization stratification factor (PAH subtype).|Aligned Rank Stratified Wilcoxon||Hodges-Lehmann location shift estimate with 95% CI is provided using aligned rank stratified Wilcoxon test stratified by a randomization stratification factor (PAH subtype).|||-1.88|-4.25|<0.001
72471722|NCT04896008|144466828|SUPERIORITY||Treatment Difference|33.05|||<|0.001|TWO_SIDED|95.0|18.41|46.98||Two-sided p-value is calculated based on Cochran-Mantel-Haenszel method stratified by a randomization stratification factor (PAH subtype).|Cochran-Mantel-Haenszel||Based on Miettinen and Nurminen method stratified by a randomization stratification factors (PAH subtype).|||46.98|18.41|<0.001
72471723|NCT04896008|144466829|SUPERIORITY||Treatment Difference|-2339.1|||<|0.001|TWO_SIDED|95.0|-3378.74|-1299.44||Two-sided p-value is provided using aligned rank stratified Wilcoxon test stratified by the randomization stratification factors (REVEAL Lite 2.0 risk score and PAH subtype).|Aligned Rank Stratified Wilcoxon||Hodges-Lehmann location shift estimate with 95% CI is provided using aligned rank stratified Wilcoxon test stratified by the randomization stratification factors (REVEAL Lite 2.0 risk score and PAH subtype).|||-1299.44|-3378.74|<0.001
72506141|NCT02101411|144544173|OTHER|The Chi-squared test was used for comparisons of all categorical variables. If 20% of the cells had an expected value \< 5, then Fisher's exact test was used.|Hazard Ratio (HR)|1.02|STANDARD_DEVIATION|0.005||0.002|TWO_SIDED|||||The Chi-squared test was used for comparisons of all categorical variables. If 20% of the cells had an expected value \< 5, then Fisher's exact test was used.|Chi-squared|||The differences among the three PRU groups (\<85, 85-208,\>208) and ADEs were compared using the Chi-squared test.||||0.002
72506142|NCT01240811|144544193|SUPERIORITY_OR_OTHER|||||||0.8||95.0|||||ANOVA|||||||0.80
72397394|NCT01850524|144301061|SUPERIORITY||Hazard Ratio (HR)|0.86||||0.26|TWO_SIDED|95.0|0.661|1.12|||Log Rank|Log-rank test is stratified by age (\<75 years vs \>=75), ISS (stage I or II vs stage III), and BPI-SF worst pain score (\<4 vs \>=4) at screening.|Hazard ratio is based on an unadjusted Cox's proportional hazard regression model stratified by age (\<75 years vs \>=75), ISS (stage I or II vs stage III), and BPI-SF worst pain score (\<4 vs \>=4) at screening.|Time to Pain Progression||1.120|0.661|0.260
72471724|NCT04896008|144466830|SUPERIORITY||Treatment Difference|-21.2|||<|0.001|TWO_SIDED|95.0|-27.78|-14.59||Two-sided p-value is provided using aligned rank stratified Wilcoxon test stratified by the randomization stratification factors (REVEAL Lite 2.0 risk score and PAH subtype).|Aligned Rank Stratified Wilcoxon||Hodges-Lehmann location shift estimate with 95% CI is provided using aligned rank stratified Wilcoxon test stratified by the randomization stratification factors (REVEAL Lite 2.0 risk score and PAH subtype).|||-14.59|-27.78|<0.001
72506143|NCT01240811|144544193|SUPERIORITY_OR_OTHER|||||||0.97||95.0|||||ANOVA|||||||0.97
72506144|NCT01240811|144544194|SUPERIORITY|||||||0.08|||||||Kruskal-Wallis|||Difference in paired change in Nugent score from baseline to 2 months||||0.08
72506145|NCT01240811|144544195|SUPERIORITY|||||||0.46|||||||Kruskal-Wallis|||Change in quantity of H2O2 producing Lactobacilli species by qPCR||||0.46
72506146|NCT01240811|144544195|SUPERIORITY|||||||0.62|||||||Kruskal-Wallis|||Change in quantity of Garnerella vaginalis species by qPCR||||0.62
72506147|NCT03990766|144544196|SUPERIORITY||Risk Difference (RD)|3.3|||||TWO_SIDED|95.0|-35.6|42.3||||||||42.3|-35.6|
72506148|NCT03990766|144544197|SUPERIORITY||Median Difference (Net)|1.0|||||TWO_SIDED|95.0|-3.0|5.0||||||||5|-3|
72506149|NCT03990766|144544198|SUPERIORITY||Median Difference (Net)|-10.0|||||TWO_SIDED|95.0|-15.0|-4.0||||||The within-subject change in QOD-NS scores from baseline and 6 weeks was calculated for each individual patient. Then the median of all the patients' change in score for each cohort was calculated. Because these were within-subject changes in scores, the median difference values for each cohort do not necessarily correspond with simply subtracting the median change in score in the theophylline cohort from the median change in score in the placebo cohort.||-4|-15|
72397395|NCT00459667|144301085|SUPERIORITY_OR_OTHER||Number of patients w/ Flu-Like-Syndrome|17.4||||||95.0|14.4|20.7||||||The 95% Confidence Interval was calculated for number of patients w/ Flu-Like-Syndrome||20.7|14.4|
72471725|NCT04896008|144466831|SUPERIORITY||Treatment Difference|-339.6|||<|0.001|TWO_SIDED|95.0|-511.09|-168.06||Two-sided p-value is provided using aligned rank stratified Wilcoxon test stratified by the randomization stratification factors (REVEAL Lite 2.0 risk score and PAH subtype).|Aligned Rank Stratified Wilcoxon||Hodges-Lehmann location shift estimate with 95% CI is provided using aligned rank stratified Wilcoxon test stratified by the randomization stratification factors (REVEAL Lite 2.0 risk score and PAH subtype).|||-168.06|-511.09|<0.001
72471726|NCT04896008|144466832|SUPERIORITY||Treatment Difference|27.41|||<|0.001|TWO_SIDED|95.0|12.85|40.98||Two-sided p-value is calculated based on Cochran-Mantel-Haenszel method stratified by the randomization stratification factors (REVEAL Lite 2.0 risk score and PAH subtype).|Cochran-Mantel-Haenszel||Based on Miettinen and Nurminen method stratified by the randomization stratification factors (REVEAL Lite 2.0 risk score and PAH subtype).|||40.98|12.85|<0.001
72471727|NCT04896008|144466833|SUPERIORITY||Treatment Difference|63.0|||<|0.001|TWO_SIDED|95.0|23.22|102.73||Two-sided p-value is provided using aligned rank stratified Wilcoxon test stratified by randomization stratification factor (REVEAL Lite 2.0 risk score and PAH subtype).|Aligned Rank Stratified Wilcoxon||Hodges-Lehmann location shift estimate with 95% CI is provided using aligned rank stratified Wilcoxon test stratified by randomization stratification factor (REVEAL Lite 2.0 risk score and PAH subtype).|||102.73|23.22|<0.001
72471728|NCT04896008|144466834|SUPERIORITY||Treatment Difference|0.5||||0.119|TWO_SIDED|95.0|-0.18|1.16||Two-sided p-value is provided using aligned rank stratified Wilcoxon test stratified by randomization stratification factor (REVEAL Lite 2.0 risk score and PAH subtype)|Aligned Rank Stratified Wilcoxon||Hodges-Lehmann location shift estimate with 95% CI is provided using aligned rank stratified Wilcoxon test stratified by randomization stratification factor (REVEAL Lite 2.0 risk score and PAH subtype).|||1.16|-0.18|0.119
72471729|NCT01270828|144466836|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||Log Rank|||Kaplan-Meier method was used for the analysis.||||<0.0001
72471730|NCT01270828|144466837|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||Log Rank|||Kaplan-Meier method was used for the analysis.||||<0.0001
72471731|NCT01270828|144466838|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||Chi-squared|||Chi-square test was used for analysis.||||<0.0001
72471732|NCT01270828|144466839|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||Chi-squared|||Chi-square test was used for analysis.||||<0.0001
72471733|NCT01270828|144466840|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.94|STANDARD_ERROR_OF_MEAN|0.16|<|0.0001|TWO_SIDED|95.0|-1.26|-0.62|||ANCOVA|||This ANCOVA model analysis is for SB Baseline to Week 19. Estimates and p-values are from an ANCOVA main effects model with baseline value, pooled center decided before unblinding, and treatment in the model.||-0.62|-1.26|<0.0001
72471734|NCT01270828|144466840|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.91|STANDARD_ERROR_OF_MEAN|0.15|<|0.0001|TWO_SIDED|95.0|-1.21|-0.61|||ANCOVA|||This ANCOVA model analysis is for DB Baseline to Week 19. Estimates and p-values are from an ANCOVA main effects model with baseline value, pooled center decided before unblinding, and treatment in the model.||-0.61|-1.21|<0.0001
72471735|NCT01270828|144466841|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.1|||<|0.0001|TWO_SIDED|95.0|-1.47|-0.75|||ANCOVA|||This ANCOVA model analysis is for SB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.||-0.75|-1.47|<0.0001
72397396|NCT00459667|144301085|SUPERIORITY_OR_OTHER||Number of patients w/ Flu-Like-Syndrome|15.8||||||95.0|13.1|18.9||||||The 95% Confidence Interval was calculated for number of patients w/ Flu-Like-Syndrome||18.9|13.1|
72397397|NCT00459667|144301085|SUPERIORITY_OR_OTHER||Number of patients w/ Flu-Like-Syndrome|31.1||||||95.0|24.4|38.4||||||The 95% Confidence Interval was calculated for number of patients w/ Flu-Like-Syndrome||38.4|24.4|
72471736|NCT01270828|144466841|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.0|||<|0.0001|TWO_SIDED|95.0|-1.34|-0.65|||ANCOVA|||This ANCOVA model analysis is for DB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.||-0.65|-1.34|<0.0001
72471737|NCT01270828|144466842|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.2||||0.0324|TWO_SIDED|95.0|-6.1|-0.3|||ANCOVA|||This ANCOVA model analysis is for Sleep Problem Index I-SB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.||-0.3|-6.1|0.0324
72471738|NCT01270828|144466842|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.3||||0.0223|TWO_SIDED|95.0|-6.1|-0.5|||ANCOVA|||This ANCOVA model analysis is for Sleep Problem Index I-DB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.||-0.5|-6.1|0.0223
72471739|NCT01270828|144466842|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.8||||0.0098|TWO_SIDED|95.0|-6.6|-0.9|||ANCOVA|||"This ANCOVA model analysis is for Sleep Problem Index II-SB Baseline to Week 19.~Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model."||-0.9|-6.6|0.0098
72471740|NCT01270828|144466842|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.0||||0.0033|TWO_SIDED|95.0|-6.7|-1.4|||ANCOVA|||"This ANCOVA model analysis is for Sleep Problem Index II-DB Baseline to Week 19.~Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model."||-1.4|-6.7|0.0033
72622944|NCT00773461|144776117|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.3|||<|0.0001|TWO_SIDED|95.0|-24.5|-14.0|||ANCOVA|||||-14.0|-24.5|<0.0001
72397398|NCT00459667|144301086|SUPERIORITY_OR_OTHER||number of patients w/ IS reactions.|31.7||||||95.0|28.0|35.7||||||The 95% Confidence Interval was calculated for number of patients w/ Injection-site (IS) reactions.||35.7|28.0|
72397399|NCT00459667|144301086|SUPERIORITY_OR_OTHER||number of patients w/ IS reactions.|26.2||||||95.0|22.8|29.8||||||The 95% Confidence Interval was calculated for number of patients w/ Injection-site (IS) reactions.||29.8|22.8|
72397400|NCT00459667|144301086|SUPERIORITY_OR_OTHER||number of patients w/ IS reactions.|31.7||||||95.0|24.9|39.0||||||The 95% Confidence Interval was calculated for number of patients w/ Injection-site (IS) reactions.||39.0|24.9|
72397401|NCT01199289|144301112|SUPERIORITY||LS Mean Difference|-0.068||||0.5838|TWO_SIDED|95.0|-0.311|0.175|||ANCOVA|||||0.175|-0.311|0.5838
72397402|NCT01199289|144301112|SUPERIORITY||LS Mean Difference|-0.075||||0.5391|TWO_SIDED|95.0|-0.316|0.166|||ANCOVA|||||0.166|-0.316|0.5391
72397403|NCT01199289|144301112|SUPERIORITY||LS Mean Difference|-0.113||||0.3583|TWO_SIDED|95.0|-0.355|0.129|||ANCOVA|||||0.129|-0.355|0.3583
72397404|NCT01199289|144301113|SUPERIORITY||LS Mean Difference|-0.047||||0.4076|TWO_SIDED|95.0|-0.157|0.064|||ANCOVA|||Pre-Bronchodilator||0.064|-0.157|0.4076
72397405|NCT01199289|144301113|SUPERIORITY||LS Mean Difference|-0.022||||0.6915|TWO_SIDED|95.0|-0.13|0.086|||ANCOVA|||Pre-Bronchodilator||0.086|-0.130|0.6915
72397406|NCT01199289|144301113|SUPERIORITY||LS Mean Difference|-0.019||||0.7271|TWO_SIDED|95.0|-0.126|0.088|||ANCOVA|||Pre-Bronchodilator||0.088|-0.126|0.7271
72397407|NCT01199289|144301113|SUPERIORITY||LS Mean Difference|0.005||||0.921|TWO_SIDED|95.0|-0.086|0.095|||ANCOVA|||Post-Bronchodilator||0.095|-0.086|0.9210
72397408|NCT01199289|144301113|SUPERIORITY||LS Mean Difference|0.07||||0.1139|TWO_SIDED|95.0|-0.017|0.157|||ANCOVA|||Post-Bronchodilator||0.157|-0.017|0.1139
72471741|NCT01270828|144466842|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-7.3||||0.0002|TWO_SIDED|95.0|-11.1|-3.5|||ANCOVA|||This ANCOVA model analysis is for Sleep Disturbance-SB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.||-3.5|-11.1|0.0002
72471742|NCT01270828|144466842|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-8.7|||<|0.0001|TWO_SIDED|95.0|-12.2|-5.2|||ANCOVA|||This ANCOVA model analysis is for Sleep Disturbance-DB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.||-5.2|-12.2|<0.0001
72471743|NCT01270828|144466842|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.4||||0.5264|TWO_SIDED|95.0|-2.8|5.6|||ANCOVA|||This ANCOVA model analysis is for Snoring-SB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.||5.6|-2.8|0.5264
72471744|NCT01270828|144466842|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.4||||0.452|TWO_SIDED|95.0|-5.2|2.3|||ANCOVA|||This ANCOVA model analysis is for Snoring-DB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.||2.3|-5.2|0.4520
72471745|NCT01270828|144466842|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.5||||0.3714|TWO_SIDED|95.0|-4.7|1.8|||ANCOVA|||"This ANCOVA model analysis is for Awaken Short of Breath or with a Headache-SB Baseline to Week 19.~Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model."||1.8|-4.7|0.3714
72471746|NCT01270828|144466842|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.0||||0.5639|TWO_SIDED|95.0|-4.2|2.3|||ANCOVA|||"This ANCOVA model analysis is for Awaken Short of Breath or with a Headache-DB Baseline to Week 19.~Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model."||2.3|-4.2|0.5639
72471747|NCT01270828|144466842|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.5||||0.3223|TWO_SIDED|95.0|-2.4|7.3|||ANCOVA|||This ANCOVA model analysis is for Sleep adequacy-SB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.||7.3|-2.4|0.3223
72471748|NCT01270828|144466842|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.7||||0.2742|TWO_SIDED|95.0|-2.2|7.6|||ANCOVA|||This ANCOVA model analysis is for Sleep adequacy-DB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.||7.6|-2.2|0.2742
72471749|NCT01270828|144466842|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0||||0.9816|TWO_SIDED|95.0|-3.2|3.1|||ANCOVA|||This ANCOVA model analysis is for Somnolence-SB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.||3.1|-3.2|0.9816
72471750|NCT01270828|144466842|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.1||||0.9282|TWO_SIDED|95.0|-2.9|3.2|||ANCOVA|||This ANCOVA model analysis is for Somnolence-DB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.||3.2|-2.9|0.9282
72397409|NCT01199289|144301113|SUPERIORITY||LS Mean Difference|0.021||||0.6426|TWO_SIDED|95.0|-0.066|0.107|||ANCOVA|||Post-Bronchodilator||0.107|-0.066|0.6426
72397410|NCT01199289|144301114|SUPERIORITY||LS Mean Difference|-16.847||||0.0262|TWO_SIDED|95.0|-31.686|-2.009|||ANCOVA|||AM||-2.009|-31.686|0.0262
72397411|NCT01199289|144301114|SUPERIORITY||LS Mean Difference|-6.723||||0.3627|TWO_SIDED|95.0|-21.239|7.793|||ANCOVA|||AM||7.793|-21.239|0.3627
72397412|NCT01199289|144301114|SUPERIORITY||LS Mean Difference|-5.488||||0.4507|TWO_SIDED|95.0|-19.791|8.814|||ANCOVA|||AM||8.814|-19.791|0.4507
72397413|NCT01199289|144301114|SUPERIORITY||LS Mean Difference|-10.426||||0.1228|TWO_SIDED|95.0|-23.686|2.834|||ANCOVA|||PM||2.834|-23.686|0.1228
72397414|NCT01199289|144301114|SUPERIORITY||LS Mean Difference|-6.738||||0.3092|TWO_SIDED|95.0|-19.758|6.281|||ANCOVA|||PM||6.281|-19.758|0.3092
72397415|NCT01199289|144301114|SUPERIORITY||LS Mean Difference|-8.043||||0.2167|TWO_SIDED|95.0|-20.831|4.744|||ANCOVA|||PM||4.744|-20.831|0.2167
72397416|NCT01199289|144301115|SUPERIORITY||LS Mean Difference|0.331||||0.5157|TWO_SIDED|95.0|-0.67|1.332|||ANCOVA|||||1.332|-0.670|0.5157
72397417|NCT01199289|144301115|SUPERIORITY||LS Mean Difference|-0.234||||0.6434|TWO_SIDED|95.0|-1.229|0.76|||ANCOVA|||||0.760|-1.229|0.6434
72397418|NCT01199289|144301115|SUPERIORITY||LS Mean Difference|-0.199||||0.6954|TWO_SIDED|95.0|-1.196|0.799|||ANCOVA|||||0.799|-1.196|0.6954
72397419|NCT01199289|144301116|SUPERIORITY||LS Mean Difference|-0.283||||0.5577|TWO_SIDED|95.0|-1.231|0.665|||ANCOVA|||||0.665|-1.231|0.5577
72397420|NCT01199289|144301116|SUPERIORITY||LS Mean Difference|0.038||||0.9366|TWO_SIDED|95.0|-0.904|0.98|||ANCOVA|||||0.980|-0.904|0.9366
72397421|NCT01199289|144301116|SUPERIORITY||LS Mean Difference|0.138||||0.7745|TWO_SIDED|95.0|-0.808|1.084|||ANCOVA|||||1.084|-0.808|0.7745
72397422|NCT01199289|144301117|SUPERIORITY||LS Mean Difference|0.026||||0.8524|TWO_SIDED|95.0|-0.251|0.303|||ANCOVA|||||0.303|-0.251|0.8524
72397423|NCT01199289|144301117|SUPERIORITY||LS Mean Difference|-0.033||||0.8139|TWO_SIDED|95.0|-0.305|0.24|||ANCOVA|||||0.240|-0.305|0.8139
72397424|NCT01199289|144301117|SUPERIORITY||LS Mean Difference|-0.002||||0.9881|TWO_SIDED|95.0|-0.281|0.276|||ANCOVA|||||0.276|-0.281|0.9881
72397425|NCT01199289|144301118|SUPERIORITY|With use of SABA|LS Mean Difference|-0.062||||0.1213|TWO_SIDED|95.0|-0.141|0.017|||ANCOVA|||||0.017|-0.141|0.1213
72397426|NCT01199289|144301118|SUPERIORITY|With use of SABA|LS Mean Difference|-0.017||||0.6643|TWO_SIDED|95.0|-0.095|0.061|||ANCOVA|||||0.061|-0.095|0.6643
72397427|NCT01199289|144301118|SUPERIORITY||LS Mean Difference|-0.042||||0.2879|TWO_SIDED|95.0|-0.121|0.036|||ANCOVA|With use of SABA||||0.036|-0.121|0.2879
72397428|NCT01199289|144301118|SUPERIORITY|Without use of SABA|LS Mean Difference|-0.074||||0.0546|TWO_SIDED|95.0|-0.15|0.001|||ANCOVA|||||0.001|-0.150|0.0546
72397429|NCT01199289|144301118|SUPERIORITY||LS Mean Difference|-0.004||||0.9078|TWO_SIDED|95.0|-0.08|0.071|||ANCOVA|||Without use of SABA||0.071|-0.080|0.9078
72397430|NCT01199289|144301118|SUPERIORITY||LS Mean Difference|-0.035||||0.3616|TWO_SIDED|95.0|-0.111|0.04|||ANCOVA|||Without use of SABA||0.040|-0.111|0.3616
72397431|NCT00501293|144301126|SUPERIORITY_OR_OTHER|||||||0.028||95.0|||||t-test, 2 sided|t-test of MTS at baseline and 6 months||||||0.028
72506150|NCT03990766|144544199|SUPERIORITY||Median Difference (Net)|7.0|||||TWO_SIDED|95.0|-2.0|17.0||||||The within-subject change in ODOR scores from baseline and 6 weeks was calculated for each individual patient. Then the median of all the patients' change in score for each cohort was calculated. Because these were within-subject changes in scores, the median difference values for each cohort do not necessarily correspond with simply subtracting the median change in score in the theophylline cohort from the median change in score in the placebo cohort. We confirmed the reported results.||17|-2|
72397432|NCT00501293|144301126|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|t-test of placebo at baseline and 6 months||||||<0.001
72397433|NCT00501293|144301127|SUPERIORITY_OR_OTHER|||||||0.027||95.0|||||t-test, 2 sided|t-test of MTS at baseline and 6 months||||||0.027
72397434|NCT00501293|144301127|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|t-test of placebo at baseline and 6 months||||||<0.001
72397435|NCT00501293|144301130|SUPERIORITY_OR_OTHER|||||||0.071||95.0|||||t-test, 2 sided|t-test of MTS at baseline and 6 months||||||0.071
72397436|NCT00501293|144301130|SUPERIORITY_OR_OTHER|||||||0.017||95.0|||||t-test, 2 sided|t-test of placebo at baseline and 6 months||||||0.017
72397437|NCT00127712|144301138|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||Chi-squared|||||||0.02
72397438|NCT00127712|144301139|SUPERIORITY_OR_OTHER|||||||0.03||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.03
72397439|NCT00127712|144301140|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||Chi-squared|||||||0.001
72397440|NCT00127712|144301141|SUPERIORITY_OR_OTHER|||||||0.79||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.79
72397441|NCT02642614|144301143|SUPERIORITY_OR_OTHER||Ratio of adjusted mean|1.59|STANDARD_ERROR_OF_MEAN|0.51||0.154|TWO_SIDED|90.0|0.93|2.72|||ANCOVA||"Standard Error of Mean is actually Standard Error of ratio of adjusted means, adjusted means ratio is calculated as 5 milligram BI 1026706 divided by Placebo."|Adjusted means were calculated by exponentiating Least Square (LS) means of corresponding values obtained from fitting an ANCOVA model to the natural log transformed endpoint variable, including treatment effect and study baseline as covariates, and adjusting for stratification factors (extensive pharmacokinetic (PK) sub-study participation and Multiple-breath washout (MBW) sub-study participation)||2.72|0.93|0.1540
72397442|NCT02642614|144301143|SUPERIORITY_OR_OTHER||Ratio of adjusted mean|1.58|STANDARD_ERROR_OF_MEAN|0.49||0.143|TWO_SIDED|90.0|0.94|2.65|||ANCOVA||"Standard Error of Mean is actually Standard Error of ratio of adjusted means, adjusted means ratio is calculated as 25 milligram BI 1026706 divided by Placebo."|The adjusted means were calculated by exponentiating the LS means of the corresponding values obtained from fitting an ANCOVA model to the natural log transformed endpoint variable, including treatment effect and study baseline as covariates, and adjusting for stratification factors (extensive PK sub-study participation and MBW sub-study participation)||2.65|0.94|0.1430
72397443|NCT02642614|144301143|SUPERIORITY_OR_OTHER||Ratio of adjusted mean|1.44|STANDARD_ERROR_OF_MEAN|0.45||0.2398|TWO_SIDED|90.0|0.86|2.41|||ANCOVA||"Standard Error of Mean is actually Standard Error of ratio of adjusted means, adjusted means ratio is calculated as 100 milligram BI 1026706 divided by Placebo."|The adjusted means were calculated by exponentiating the LS means of the corresponding values obtained from fitting an ANCOVA model to the natural log transformed endpoint variable, including treatment effect and study baseline as covariates, and adjusting for stratification factors (extensive PK sub-study participation and MBW sub-study participation)||2.41|0.86|0.2398
72397444|NCT03316131|144301196|OTHER||Mean Difference (Net)|0.28|||||TWO_SIDED|95.0|-8.67|9.22||||||||9.22|-8.67|
72397445|NCT03316131|144301197|OTHER||Geometric mean ratio|1.14|||||TWO_SIDED|90.0|1.03|1.25||||||Treatment A/Treatment B, for Verinurad||1.25|1.03|
72397446|NCT03316131|144301197|OTHER||Geometric mean ratio|0.97|||||TWO_SIDED|90.0|0.88|1.07||||||Treatment A/Treatment B, for M1||1.07|0.88|
72397447|NCT03316131|144301197|OTHER||Geometric mean ratio|0.99|||||TWO_SIDED|90.0|0.91|1.08||||||Treatment A/Treatment B, for M8||1.08|0.91|
72397448|NCT03316131|144301198|OTHER||Geometric mean ratio|1.06|||||TWO_SIDED|90.0|1.0|1.13||||||Treatment A/Treatment B, for Verinurad||1.13|1.00|
72397449|NCT03316131|144301198|OTHER||Geometric mean ratio|0.96|||||TWO_SIDED|90.0|0.9|1.02||||||Treatment A/Treatment B, for M1||1.02|0.90|
72397450|NCT03316131|144301198|OTHER||Geometric mean ratio|0.99|||||TWO_SIDED|90.0|0.94|1.04||||||Treatment A/Treatment B, for M8||1.04|0.94|
72397451|NCT03316131|144301202|OTHER||Geometric mean ratio|1.06|||||TWO_SIDED|90.0|1.0|1.13||||||Treatment A/Treatment B, for Verinurad||1.13|1.00|
72397452|NCT03316131|144301202|OTHER||Geometric mean ratio|0.96||||||90.0|0.9|1.02||||||Treatment A/Treatment B, for M1||1.02|0.90|
72397453|NCT03316131|144301202|OTHER||Geometric mean ratio|0.99|||||TWO_SIDED|90.0|0.94|1.04||||||Treatment A/Treatment B, for M8||1.04|0.94|
72397454|NCT01409564|144301203|SUPERIORITY_OR_OTHER|||||||0.14|||||||Repeated ANOVA|Uncorrected, Repeated ANOVA||Repeated-measures analysis of variance (ANOVA) was used to test group\*time interaction effect in glucose uptake of Left Parietal Lobe in two groups on two data points (baseline, 24-week).||||0.14
72397455|NCT01409564|144301203|SUPERIORITY_OR_OTHER|||||||0.08|||||||Repeated ANOVA|||Repeated-measures analysis of variance (ANOVA) was used to test group\*time interaction effect in glucose uptake of Right Parietal Lobe in two groups on two data points (baseline, 24-week).||||0.08
72397456|NCT01409564|144301203|SUPERIORITY_OR_OTHER||||||<|0.01|||||||Repeated ANOVA|||Repeated-measures analysis of variance (ANOVA) was used to test group\*time interaction effect in glucose uptake of Left Inferior Frontal Gyrus in two groups on two data points (baseline, 24-week).||||<0.01
72622945|NCT00773461|144776118|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.0|||<|0.0001|TWO_SIDED|95.0|-25.2|-12.7|||ANCOVA|||||-12.7|-25.2|<0.0001
72397457|NCT01409564|144301203|SUPERIORITY_OR_OTHER|||||||0.08|||||||Repeated ANOVA|||Repeated-measures analysis of variance (ANOVA) was used to test group\*time interaction effect in glucose uptake of Right Inferior Frontal Gyrus in two groups on two data points (baseline, 24-week).||||0.08
72397458|NCT01409564|144301204|SUPERIORITY_OR_OTHER|||||||0.93|||||||Repeated ANOVA|||Repeated ANOVA, tested for group\*time interaction effect of ADAS-Cog scores on three data points (Baseline, 12-week, 24-week)||||0.93
72397459|NCT01409564|144301205|SUPERIORITY_OR_OTHER|||||||0.15|||||||Repeated ANOVA|||Repeated ANOVA, tested for group\*time interaction effect of MMSE scores on three data points (Baseline, 12-week, 24-week)||||0.15
72397460|NCT01409564|144301206|SUPERIORITY_OR_OTHER|||||||0.82|||||||Repeated ANOVA|||Repeated ANOVA, tested for group\*time interaction effect of ADCS-ADL scores on three data points (Baseline, 12-week, 24-week)||||0.82
72397461|NCT01409564|144301207|SUPERIORITY_OR_OTHER|||||||0.79|||||||Chi-squared|||Repeated ANOVA, tested for group\*time interaction effect of Summed CDR scores on three data points (Baseline, 12-week, 24-week)||||0.79
72397462|NCT01409564|144301208|SUPERIORITY_OR_OTHER|||||||0.87|||||||Chi-squared|||Distribution of Fazekas scale in two groups according to Chi-square test results.||||0.87
72397463|NCT04309656|144301347|EQUIVALENCE|Comparisons performed: Treatment B (test) versus Treatment A (reference). Relative bioavailability of test compared to reference assessed via 90% CI. CI obtained by taking the antilog of the upper and lower limits of CI for the difference of the least squares means on the log scale within the ANOVA framework model.|Geometric mean ratio (%)|85.85||||0.0001|TWO_SIDED|90.0|81.21|90.75|||ANOVA|||||90.75|81.21|0.0001
72622946|NCT00773461|144776119|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.7384|||<|0.0001|TWO_SIDED|95.0|-2.1464|-1.3303|||ANCOVA|||||-1.3303|-2.1464|<0.0001
72397464|NCT04309656|144301347|EQUIVALENCE|Comparisons performed: Treatment B (test) versus Treatment A (reference). Relative bioavailability of test compared to reference assessed via 90% CI. CI obtained by taking the antilog of the upper and lower limits of CI for the difference of the least squares means on the log scale within the ANOVA framework model.|Geometric mean ratio (%)|92.99||||0.3001|TWO_SIDED|90.0|82.65|104.62|||ANOVA|||||104.62|82.65|0.3001
72397465|NCT04309656|144301348|EQUIVALENCE|Comparisons performed: Treatment B (test) versus Treatment A (reference). Relative bioavailability of test compared to reference assessed via 90% CI. CI obtained by taking the antilog of the upper and lower limits of CI for the difference of the least squares means on the log scale within the ANOVA framework model.|Geometric mean ratio (%)|100.6||||0.6686|TWO_SIDED|90.0|98.23|103.03|||ANOVA|||||103.03|98.23|0.6686
72397466|NCT04309656|144301348|EQUIVALENCE|Comparisons performed: Treatment B (test) versus Treatment A (reference). Relative bioavailability of test compared to reference assessed via 90% CI. CI obtained by taking the antilog of the upper and lower limits of CI for the difference of the least squares means on the log scale within the ANOVA framework model.|Geometric mean ratio (%)|89.7||||0.0745|TWO_SIDED|90.0|81.2|99.1|||ANOVA|||||99.10|81.20|0.0745
72622947|NCT00773461|144776120|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-39.2|||<|0.0001|TWO_SIDED|95.0|-44.7|-33.7|||ANCOVA|||||-33.7|-44.7|<.0001
72397467|NCT04309656|144301349|EQUIVALENCE|Comparisons performed: Treatment B (test) versus Treatment A (reference). Relative bioavailability of test compared to reference assessed via 90% CI. CI obtained by taking the antilog of the upper and lower limits of CI for the difference of the least squares means on the log scale within the ANOVA framework model.|Geometric mean ratio (%)|101.03||||0.4683|TWO_SIDED|90.0|98.65|103.47|||ANOVA|||||103.47|98.65|0.4683
72397468|NCT04309656|144301349|EQUIVALENCE|Comparisons performed: Treatment B (test) versus Treatment A (reference). Relative bioavailability of test compared to reference assessed via 90% CI. CI obtained by taking the antilog of the upper and lower limits of CI for the difference of the least squares means on the log scale within the ANOVA framework model.|Geometric mean ratio (%)|89.63||||0.0734|TWO_SIDED|90.0|81.1|99.05|||ANOVA|||||99.05|81.10|0.0734
72622948|NCT00773461|144776122|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.8||||0.0003|TWO_SIDED|95.0|1.8|5.9|||ANCOVA|||||5.9|1.8|0.0003
72397469|NCT03720470|144301354|SUPERIORITY||Difference in percentage|23.1|||<|0.0001|TWO_SIDED|95.0|14.7|31.4|||Cochran-Mantel-Haenszel|||Difference in percentage (PF-04965842 versus placebo) and confidence interval (CI) for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions. P-value was adjusted by baseline disease severity.||31.4|14.7|<0.0001
72397470|NCT03720470|144301354|SUPERIORITY||Difference in Percentage|34.8|||<|0.0001|TWO_SIDED|95.0|26.1|43.5|||Cochran-Mantel-Haenszel|||Difference in percentage (PF-04965842 versus placebo) and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions. P-value was adjusted by baseline disease severity.||43.5|26.1|<0.0001
72397471|NCT03720470|144301355|SUPERIORITY||Difference in percentage|31.9|||<|0.0001|TWO_SIDED|95.0|22.2|41.6|||Cochran-Mantel-Haenszel|||Difference in percentage (PF-04965842 versus placebo) and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions. P-value was adjusted by baseline disease severity.||41.6|22.2|<0.0001
72397472|NCT03720470|144301355|SUPERIORITY||Difference in Percentage|43.2|||<|0.0001|TWO_SIDED|95.0|33.7|52.7|||Cochran-Mantel-Haenszel|||Difference in percentage (PF-04965842 versus placebo) and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions. P-value was adjusted by baseline disease severity.||52.7|33.7|<0.0001
72397473|NCT03720470|144301356|SUPERIORITY||Difference in percentage|17.9||||0.0002|TWO_SIDED|95.0|9.5|26.3|||Cochran-Mantel-Haenszel|||Week 2: Difference in percentage (PF-04965842 versus placebo) and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions. P-value was adjusted by baseline disease severity.||26.3|9.5|0.0002
72622949|NCT00773461|144776123|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-68.3||||0.0599|TWO_SIDED|95.0|-139.5|2.9|||ANCOVA|||||2.9|-139.5|0.0599
72622950|NCT00773461|144776124|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.956|||<|0.0001|TWO_SIDED|95.0|9.125|16.786|||ANCOVA|||||16.786|9.125|<0.0001
72622951|NCT00773461|144776125|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.42|||<|0.0001|TWO_SIDED|95.0|-0.56|-0.28|||ANCOVA|||||-0.28|-0.56|<0.0001
72622952|NCT00322218|144776134|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8578|||||||Stratified Log-Rank Test|||||||0.8578
72506151|NCT01543490|144544203|SUPERIORITY|Statistical hypotheses testing for the primary efficacy endpoint was 2-sided and performed using a significance (alpha) level of 0.05.|Risk Difference (RD)|8.5|STANDARD_ERROR_OF_MEAN|4.03||0.0354|TWO_SIDED|95.0|0.2|16.6||The p-value was from a 2-sided Fisher's exact test.|Fisher Exact|The point estimate of treatment effect (ISV-305 compared with Vehicle) was reported using Fisher's exact test.|The risk difference was obtained by taking the difference in proportions (ISV-305 minus Vehicle). A 2-sided exact unconditional 95% confidence interval (CI) was calculated.|||16.6|0.2|0.0354
72506152|NCT01543490|144544204|SUPERIORITY|Statistical hypotheses testing for the secondary efficacy endpoint was 2-sided and performed using a significance (alpha) level of 0.05, and missing data imputed using the LOCF approach.|Risk Difference (RD)|7.1|STANDARD_ERROR_OF_MEAN|4.07||0.1036|TWO_SIDED|95.0|-1.3|15.0||The p-value was from a 2-sided Fisher's exact test.|Fisher Exact|The point estimate of treatment effect (ISV-305 compared with Vehicle) was reported using Fisher's exact test.|The risk difference was obtained by taking the difference in proportions (ISV-305 minus Vehicle). A 2-sided exact unconditional 95% CI was calculated.|||15.0|-1.3|0.1036
72471751|NCT01270828|144466843|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.2||||0.1635|TWO_SIDED|95.0|-0.1|0.4|||ANCOVA|||This ANCOVA model analysis is for SB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.||0.4|-0.1|0.1635
72471752|NCT01270828|144466843|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.2||||0.0363||95.0|0.0|0.5|||ANCOVA|||This ANCOVA model analysis is for DB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.||0.5|0.0|0.0363
72471753|NCT01270828|144466844|SUPERIORITY_OR_OTHER_LEGACY|||||||0.432|||||||Chi-squared|||This analysis is for Week 6||||0.432
72471754|NCT01270828|144466844|SUPERIORITY_OR_OTHER_LEGACY|||||||0.987|||||||Chi-squared|||This analysis is for Week 19||||0.987
72471755|NCT01270828|144466845|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.85||||0.0007|TWO_SIDED|95.0|1.3|2.65|||Regression, Logistic||"Odds ratio is the probability of the event occurring in Pregabalin DB relative to the event occurring in Placebo DB.~Odds ratio \> 1 is in favor of Pregabalin DB."|This analysis is for the original score. Proportional odds Logistic regression with a term for treatment in the model.||2.65|1.30|0.0007
72471756|NCT01270828|144466845|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.32||||0.0009|TWO_SIDED|95.0|1.41|3.81|||Regression, Logistic||"Odds ratio is the probability of the event occurring in Pregabalin DB relative to the event occurring in Placebo DB.~Odds ratio \> 1 is in favor of Pregabalin DB."|This analysis is for the categorized score. Proportional odds Logistic regression with a term for treatment in the model.||3.81|1.41|0.0009
72471757|NCT01270828|144466846|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|7.4||||0.0003|TWO_SIDED|95.0|3.4|11.5|||ANCOVA|||This ANCOVA model analysis is for Bodily pain-SB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.||11.5|3.4|0.0003
72471758|NCT01270828|144466846|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|7.7|||<|0.0001|TWO_SIDED|95.0|4.0|11.3|||ANCOVA|||This ANCOVA model analysis is for Bodily pain-DB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.||11.3|4.0|<0.0001
72471759|NCT01270828|144466846|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.2||||0.0275|TWO_SIDED|95.0|0.4|6.0|||ANCOVA|||"This ANCOVA model analysis is for General Health Perceptions-SB Baseline to Week 19.~Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model."||6.0|0.4|0.0275
72506153|NCT03918642|144544222|SUPERIORITY||Mean Difference (Net)|-1.59|||<|0.001|TWO_SIDED|95.0|-2.35|-0.83|||Mixed Models Analysis|||||-0.83|-2.35|<0.001
72506154|NCT03918642|144544223|SUPERIORITY||Mean Difference (Net)|-1.01||||0.01|TWO_SIDED|95.0|-1.78|-0.24|||Mixed Models Analysis|||||-0.24|-1.78|0.01
72471760|NCT01270828|144466846|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.4|||<|0.0001|TWO_SIDED|95.0|2.8|8.0|||ANCOVA|||"This ANCOVA model analysis is for General Health Perceptions-DB Baseline to Week 19.~Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model."||8.0|2.8|<0.0001
72471761|NCT01270828|144466846|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.0||||0.0735|TWO_SIDED|95.0|-0.3|6.4|||ANCOVA|||This ANCOVA model analysis is for Vitality-SB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.||6.4|-0.3|0.0735
72471762|NCT01270828|144466846|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.0||||0.0684|TWO_SIDED|95.0|-0.2|6.2|||ANCOVA|||This ANCOVA model analysis is for Vitality-DB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.||6.2|-0.2|0.0684
72471763|NCT01270828|144466846|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.8||||0.1197|TWO_SIDED|95.0|-0.7|6.4|||ANCOVA|||This ANCOVA model analysis is for Social Functioning-SB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.||6.4|-0.7|0.1197
72471764|NCT01270828|144466846|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.1||||0.221|TWO_SIDED|95.0|-1.3|5.5|||ANCOVA|||This ANCOVA model analysis is for Social Functioning-DB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.||5.5|-1.3|0.2210
72506155|NCT03918642|144544224|SUPERIORITY||Mean Difference (Net)|0.28|||<|0.001|TWO_SIDED|95.0|0.12|0.45|||Mixed Models Analysis|||||0.45|0.12|<0.001
72506156|NCT03918642|144544225|SUPERIORITY||Mean Difference (Net)|-1.42||||0.14|TWO_SIDED|95.0|-3.3|0.46|||Mixed Models Analysis|||||0.46|-3.30|0.14
72506157|NCT03918642|144544226|SUPERIORITY||Mean Difference (Net)|0.21||||0.85|TWO_SIDED|95.0|-1.99|2.42|||Mixed Models Analysis|||||2.42|-1.99|0.85
72506158|NCT03918642|144544227|SUPERIORITY||Mean Difference (Net)|-3.06||||0.03|TWO_SIDED|95.0|-5.88|-0.25|||Mixed Models Analysis|||||-0.25|-5.88|0.03
72506159|NCT03918642|144544228|SUPERIORITY||Mean Difference (Net)|-2.39||||0.02|TWO_SIDED|95.0|-4.33|-0.45|||Mixed Models Analysis|||||-0.45|-4.33|0.02
72506160|NCT03918642|144544229|SUPERIORITY||Mean Difference (Net)|-2.49||||0.006|TWO_SIDED|95.0|-4.3|-0.68|||Mixed Models Analysis|||||-0.68|-4.30|0.006
72565750|NCT02709486|144662696|SUPERIORITY||Least Square Mean Difference|-0.78|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-1.06|-0.5|||ANCOVA|||Week 3: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.||-0.50|-1.06|<.0001
72622953|NCT00500331|144776166|OTHER|Tukey's trend test for dose response: Change= Baseline+Treatment|||||<|0.001||||||Tukey's trend test adjusts for multiplicity with statistical significance based on p-value \<0.05|ANCOVA|Change= Baseline+Treatment||Placebo, GSK189075 50 mg, GSK189075 100 mg, GSK189075 250 mg, GSK189075 500 mg, GSK189075 1000 mg||||<0.001
72471765|NCT01270828|144466846|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.3||||0.0847|TWO_SIDED|95.0|-0.5|7.1|||ANCOVA|||This ANCOVA model analysis is for Role-Emotional-SB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.||7.1|-0.5|0.0847
72471766|NCT01270828|144466846|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.0||||0.0365|TWO_SIDED|95.0|0.3|7.8|||ANCOVA|||This ANCOVA model analysis is for Role-Emotional-DB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.||7.8|0.3|0.0365
72471767|NCT01270828|144466846|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.6||||0.2749|TWO_SIDED|95.0|-1.2|4.3|||ANCOVA|||This ANCOVA model analysis is for Mental Health-SB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.||4.3|-1.2|0.2749
72471768|NCT01270828|144466846|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.5||||0.0806|TWO_SIDED|95.0|-0.3|5.2|||ANCOVA|||This ANCOVA model analysis is for Mental Health-SB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.||5.2|-0.3|0.0806
72471769|NCT01270828|144466846|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.0||||0.0082|TWO_SIDED|95.0|0.5|3.4|||ANCOVA|||This ANCOVA model analysis is for Physical component-SB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.||3.4|0.5|0.0082
72471770|NCT01270828|144466846|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.3||||0.0008|TWO_SIDED|95.0|1.0|3.7|||ANCOVA|||This ANCOVA model analysis is for Physical component-DB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.||3.7|1.0|0.0008
72471771|NCT01270828|144466846|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.9||||0.2097|TWO_SIDED|95.0|-0.8|2.5|||ANCOVA|||This ANCOVA model analysis is for Mental component-SB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.||2.5|-0.8|0.2097
72471772|NCT01270828|144466846|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.2||||0.1669|TWO_SIDED|95.0|-0.5|2.8|||ANCOVA|||This ANCOVA model analysis is for Mental component-DB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.||2.8|-0.5|0.1669
72471773|NCT01270828|144466846|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.8||||0.1466|TWO_SIDED|95.0|-1.0|6.7|||ANCOVA|||This ANCOVA model analysis is for Physical functioning-SB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.||6.7|-1.0|0.1466
72506161|NCT03918642|144544230|SUPERIORITY||Mean Difference (Net)|-1.95||||0.11|TWO_SIDED|95.0|-4.34|0.45|||Mixed Models Analysis|||||0.45|-4.34|0.11
72506162|NCT03918642|144544231|SUPERIORITY||Mean Difference (Net)|-4.39||||0.03|TWO_SIDED|95.0|-8.44|-0.34|||Mixed Models Analysis|||||-0.34|-8.44|0.03
72622954|NCT00500331|144776166|OTHER|Tukey's trend test for dose response|||||<|0.001||||||Tukey's trend test adjusts for multiplicity with statistical significance based on p-value \<0.05|ANCOVA|||Placebo, GSK189075 50 mg, GSK189075 100 mg, GSK189075 250 mg, GSK189075 500 mg||||<0.001
72471774|NCT01270828|144466846|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.4||||0.0439|TWO_SIDED|95.0|0.1|6.7|||ANCOVA|||This ANCOVA model analysis is for Physical functioning-DB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.||6.7|0.1|0.0439
72471775|NCT01270828|144466846|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.9||||0.025|TWO_SIDED|95.0|0.6|9.3|||ANCOVA|||This ANCOVA model analysis is for Role Physical-SB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.||9.3|0.6|0.0250
72471776|NCT01270828|144466846|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.4||||0.0107|TWO_SIDED|95.0|1.3|9.5|||ANCOVA|||This ANCOVA model analysis is for Role Physical-DB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.||9.5|1.3|0.0107
72471777|NCT01270828|144466847|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.9|||<|0.0001|TWO_SIDED|95.0|-1.23|-0.64|||ANCOVA|||This ANCOVA model analysis is for SB Baseline to Week 19.Estimates and p-values are from an analysis of covariance main effects model with baseline value, pooled center decided before unblinding, and treatment in the model.||-0.64|-1.23|<0.0001
72471778|NCT01270828|144466847|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.9|||<|0.0001|TWO_SIDED|95.0|-1.12|-0.58|||ANCOVA|||This ANCOVA model analysis is for DB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with baseline value, pooled center decided before unblinding, and treatment in the model.||-0.58|-1.12|<0.0001
72506163|NCT03918642|144544232|SUPERIORITY||Mean Difference (Net)|-3.76||||0.07|TWO_SIDED|95.0|-7.83|0.32|||Mixed Models Analysis|||||0.32|-7.83|0.07
72506164|NCT03918642|144544233|SUPERIORITY||Mean Difference (Net)|1.23||||0.005|TWO_SIDED|95.0|0.36|2.1|||Mixed Models Analysis|||||2.10|0.36|0.005
72506165|NCT03918642|144544234|SUPERIORITY||Mean Difference (Net)|0.95||||0.17|TWO_SIDED|95.0|-0.4|2.29|||Mixed Models Analysis|||||2.29|-0.40|0.17
72506166|NCT03918642|144544235|SUPERIORITY||Mean Difference (Net)|-1.85||||0.11|TWO_SIDED|95.0|-4.14|0.44|||Mixed Models Analysis|||||0.44|-4.14|0.11
72397474|NCT03720470|144301356|SUPERIORITY||Difference in Percentage|34.9|||<|0.0001|TWO_SIDED|95.0|26.0|43.7|||Cochran-Mantel-Haenszel|||Week 2: Difference in percentage (PF-04965842 versus placebo) and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions. P-value was adjusted by baseline disease severity.||43.7|26.0|<.0001
72397475|NCT03720470|144301356|SUPERIORITY||Difference in Percentage|5.2||||0.2084|TWO_SIDED|95.0|-2.9|13.4|||Cochran-Mantel-Haenszel|||Week 2: Difference in percentage (PF-04965842 versus dupilumab) and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions. P-value was adjusted by baseline disease severity.||13.4|-2.9|0.2084
72397476|NCT03720470|144301356|SUPERIORITY||Difference in Percentage|22.1|||<|0.0001|TWO_SIDED|95.0|13.5|30.7|||Cochran-Mantel-Haenszel|||Week 2: Difference in percentage (PF-04965842 versus dupilumab) and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions. P-value was adjusted by baseline disease severity.||30.7|13.5|<0.0001
72397477|NCT03720470|144301357|OTHER||Difference in Percentage|22.1|||<|0.0001|TWO_SIDED|95.0|13.7|30.5|||Cochran-Mantel-Haenszel|||Week 16: Difference in percentage (PF-04965842 versus placebo) and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions. P-value was adjusted by baseline disease severity.||30.5|13.7|<0.0001
72397478|NCT03720470|144301357|OTHER||Difference in Percentage|35.0|||<|0.0001|TWO_SIDED|95.0|26.3|43.7|||Cochran-Mantel-Haenszel|||Week 16: Difference in percentage (PF-04965842 versus placebo) and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions. P-value was adjusted by baseline disease severity.||43.7|26.3|<0.0001
72471779|NCT01270828|144466848|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.7||||0.0154|TWO_SIDED|95.0|-1.2|-0.1|||ANCOVA|||This ANCOVA model analysis is for HADS-Anxiety-SB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.||-0.1|-1.2|0.0154
72471780|NCT01270828|144466848|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.8||||0.0027|TWO_SIDED|95.0|-1.3|-0.3|||ANCOVA|||This ANCOVA model analysis is for HADS-Anxiety-DB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.||-0.3|-1.3|0.0027
72471781|NCT01270828|144466848|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.7||||0.0166|TWO_SIDED|95.0|-1.2|-0.1|||ANCOVA|||This ANCOVA model analysis is for HADS-Depression-SB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.||-0.1|-1.2|0.0166
72471782|NCT01270828|144466848|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.6||||0.0217|TWO_SIDED|95.0|-1.1|-0.1|||ANCOVA|||This ANCOVA model analysis is for HADS-Depression-DB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.||-0.1|-1.1|0.0217
72471783|NCT01270828|144466849|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.2|||<|0.0001|TWO_SIDED|95.0|-5.5|-3.0|||ANCOVA|||This ANCOVA model analysis is for Pain Severity Index-SB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.||-3.0|-5.5|<0.0001
72397479|NCT03720470|144301357|OTHER||Difference in Percentage|-3.5|||||TWO_SIDED|95.0|-12.2|5.2||||||Week 16: Difference in percentage (PF-04965842 versus dupilumab) and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions. P-value was adjusted by baseline disease severity.||5.2|-12.2|
72397480|NCT03720470|144301357|OTHER||Difference in Percentage|9.4|||||TWO_SIDED|95.0|0.4|18.5||||||Week 16: Difference in percentage (PF-04965842 versus dupilumab) and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions. P-value was adjusted by baseline disease severity.||18.5|0.4|
72397481|NCT03720470|144301358|OTHER||Difference in percentage|24.1|||<|0.0001|TWO_SIDED|95.0|14.0|34.1|||Cochran-Mantel-Haenszel|||Difference in percentage (PF-04965842 versus placebo) and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions. P-value was adjusted by baseline disease severity.||34.1|14.0|<0.0001
72471784|NCT01270828|144466849|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.8|||<|0.0001|TWO_SIDED|95.0|-5.0|-2.7|||ANCOVA|||This ANCOVA model analysis is for Pain Severity Index-DB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.||-2.7|-5.0|<0.0001
72471785|NCT01270828|144466849|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.6|||<|0.0001|TWO_SIDED|95.0|-6.5|-2.7|||ANCOVA|||"This ANCOVA model analysis is for Pain Interference Index-SB Baseline to Week 19.~Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model."||-2.7|-6.5|<0.0001
72471786|NCT01270828|144466849|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.2|||<|0.0001|TWO_SIDED|95.0|-6.0|-2.4|||ANCOVA|||"This ANCOVA model analysis is for Pain Interference Index-DB Baseline to Week 19.~Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model."||-2.4|-6.0|<0.0001
72506167|NCT03918642|144544236|SUPERIORITY||Mean Difference (Net)|-2.57||||0.11|TWO_SIDED|95.0|-5.73|0.6|||Mixed Models Analysis|||||0.60|-5.73|0.11
72506168|NCT03918642|144544237|SUPERIORITY||Mean Difference (Net)|-0.78||||0.33|TWO_SIDED|95.0|-2.33|0.78|||Mixed Models Analysis|||||0.78|-2.33|0.33
72397482|NCT03720470|144301358|OTHER||Difference in Percentage|30.1|||<|0.0001|TWO_SIDED|95.0|20.3|39.8|||Cochran-Mantel-Haenszel|||Difference in percentage (PF-04965842 versus placebo) and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions. P-value was adjusted by baseline disease severity.||39.8|20.3|<0.0001
72397483|NCT03720470|144301358|OTHER||Difference in Percentage|-2.7|||||TWO_SIDED|95.0|-9.6|4.2||||||Week 16: Difference in percentage (PF-04965842 versus dupilumab) and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions. P-value was adjusted by baseline disease severity.||4.2|-9.6|
72471787|NCT01270828|144466850|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|4.77||||0.0161|TWO_SIDED|95.0|1.34|17.0|||Regression, Logistic||Odds ratio was the probability of the event occurring in pregabalin CR DB relative to the event occurring in placebo DB. Odds ratio \> 1 was in favor of pregabalin CR.|This analysis is for 'Benefit from treatment'. Proportional odds logistic regression was used with a term for treatment in the model.||17.00|1.34|0.0161
72471788|NCT01270828|144466850|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.48||||0.0378|TWO_SIDED|95.0|1.05|5.85|||Regression, Logistic||Odds ratio was the probability of the event occurring in pregabalin CR DB relative to the event occurring in placebo DB. Odds ratio \> 1 was in favor of pregabalin CR.|This analysis is for 'Satisfaction with treatment'. Proportional odds logistic regression was used with a term for treatment in the model.||5.85|1.05|0.0378
72397484|NCT03720470|144301358|OTHER||Difference in Percentage|3.1|||||TWO_SIDED|95.0|-3.3|9.6||||||Week 16: Difference in percentage (PF-04965842 versus dupilumab) and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions. P-value was adjusted by baseline disease severity.||9.6|-3.3|
72397485|NCT00453921|144301385|OTHER||||||<|0.04||||||For active therapy/placebo relative to both placebo|Kruskal-Wallis|||||||<0.04
72397486|NCT00453921|144301387|EQUIVALENCE|Looking for statistical difference, p \< .01, between groups looking at change scores|||||<|0.05|||||||ANOVA|||||||<0.05
72397487|NCT00453921|144301388|EQUIVALENCE|group differences|||||<|0.05|||||||ANCOVA|||||||<0.05
72397488|NCT00453921|144301391|OTHER||||||<|0.01|||||||ANCOVA|||||||<0.01
72397489|NCT00453921|144301391|SUPERIORITY||||||<|0.05||||||a priopr|ANCOVA|||||||<0.05
72397490|NCT00530764|144301414|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.37||||0.33|TWO_SIDED|95.0|0.72|2.6|||Regression, Logistic|||The proportions of responders were compared between the treatment groups using logistic regression with region and treatment groups as factors. The null hypothesis was that there was no difference between each of the Sativex treatment groups and placebo. The estimated response rates, odds ratios, 95% CIs for the odds ratios and p-values were presented.||2.60|0.72|0.33
72397491|NCT00530764|144301414|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.9||||0.62|TWO_SIDED|95.0|0.46|1.76|||Regression, Logistic|||As for Sativex Low dose versus placebo||1.76|0.46|0.62
72471789|NCT01270828|144466850|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.61||||0.0901|TWO_SIDED|95.0|0.93|2.81|||Regression, Logistic||Odds ratio was the probability of the event occurring in pregabalin CR DB relative to the event occurring in placebo DB. Odds ratio \> 1 was in favor of pregabalin CR.|This analysis is for 'Willingness to continue treatment'. Proportional odds logistic regression was used with a term for treatment in the model.||2.81|0.93|0.0901
72397492|NCT00530764|144301414|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.19||||0.61|TWO_SIDED|95.0|0.62|2.28|||Regression, Logistic|||As for Sativex Low dose versus placebo||2.28|0.62|0.61
72397493|NCT00530764|144301415|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-12.5||||0.0077|TWO_SIDED|95.0|-21.35|-3.33|||Wilcoxon rank sum tests|||Each of the active treatment groups were compared with placebo using pairwise Wilcoxon rank-sum tests. The Hodges-Lehmann estimates and 95% CI for the median differences were also presented.||-3.33|-21.35|0.0077
72397494|NCT00530764|144301415|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-1.97||||0.67|TWO_SIDED|95.0|-11.04|7.14|||Wilcoxin rank sum test|||As for Sativex low dose versus placebo||7.14|-11.04|0.67
72471790|NCT00709228|144466865|SUPERIORITY_OR_OTHER||simple proportion|0.097|||||TWO_SIDED|95.0|0.06|0.15||||||||0.15|0.06|
72471791|NCT02870972|144466871|SUPERIORITY||Difference in Least Square Means|-0.458|||<|0.001|TWO_SIDED|95.0|-0.703|-0.214|||ANCOVA|||The primary analysis of treatment-effect was performed using an ANCOVA with the adjusted qualifying attack rate as the covariate.||-0.214|-0.703|<0.001
72506169|NCT03918642|144544238|SUPERIORITY||Mean Difference (Net)|-0.3||||0.69|TWO_SIDED|95.0|-1.74|1.14|||Mixed Models Analysis|||||1.14|-1.74|0.69
72397495|NCT00530764|144301415|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-8.75||||0.039|TWO_SIDED|95.0|-17.14|0.0|||Wilcoxin rank sum test|||As for Sativex low dose versus placebo||0.00|-17.14|0.039
72397496|NCT00530764|144301416|SUPERIORITY_OR_OTHER||Estimated treatment effect|-0.75||||0.006|TWO_SIDED|95.0|-1.28|-0.22|||ANCOVA|||The change in mean pain NRS score (average pain) was analyzed using analysis of covariance (ANCOVA) with the baseline value as a covariate and region and treatment group as factors.||-0.22|-1.28|0.006
72397497|NCT00530764|144301416|SUPERIORITY_OR_OTHER||Estimated treatment effect|-0.09||||0.75|TWO_SIDED|95.0|-0.62|0.44|||ANCOVA|||As for Sativex low dose versus placebo||0.44|-0.62|0.75
72397498|NCT00530764|144301416|SUPERIORITY_OR_OTHER||Estimated treatment effect|-0.36||||0.19|TWO_SIDED|95.0|-0.89|0.18|||ANCOVA|||As for Sativex low dose versus placebo||0.18|-0.89|0.19
72397499|NCT00530764|144301417|SUPERIORITY_OR_OTHER||Estimated treatment effect|-0.73||||0.011|TWO_SIDED|95.0|-1.3|-0.17|||ANCOVA|||The change in mean pain NRS score (worst pain) was analyzed using ANCOVA with the baseline value as a covariate and region and treatment group as factors.||-0.17|-1.30|0.011
72397500|NCT00530764|144301417|SUPERIORITY_OR_OTHER||Estimated treatment effect|-0.35||||0.14|TWO_SIDED|95.0|-0.81|0.11|||ANCOVA|||As for Sativex low dose versus placebo||0.11|-0.81|0.14
72397501|NCT00530764|144301417|SUPERIORITY_OR_OTHER||Estimated Treatment Effect|-0.24||||0.4|TWO_SIDED|95.0|-0.81|0.32|||ANCOVA|||As for Sativex low dose versus placebo||0.32|-0.81|0.40
72397502|NCT00530764|144301418|SUPERIORITY_OR_OTHER||Estimated Treatment Effect|-0.88||||0.003|TWO_SIDED|95.0|-1.45|-0.31|||ANCOVA|||The change in mean sleep disturbance NRS score was analyzed using ANCOVA with the baseline value as a covariate and region and treatment group as factors.||-0.31|-1.45|0.003
72397503|NCT00530764|144301418|SUPERIORITY_OR_OTHER||Estimated Treatment Effect|-0.08||||0.78|TWO_SIDED|95.0|-0.65|0.49|||ANCOVA|||As for Sativex low dose versus placebo||0.49|-0.65|0.78
72397504|NCT00530764|144301418|SUPERIORITY_OR_OTHER||Estimated Treatment Effect|-0.33||||0.26|TWO_SIDED|95.0|-0.9|0.24|||ANCOVA|||As for Sativex low dose versus placebo.||0.24|-0.90|0.26
72397505|NCT00467259|144301426|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|p-value obtained from Fisher's exact test and corresponds to the test of the null hypothesis of no treatment difference.||1000 naturally postmenopausal women not on concomitant E+P therapy at baseline were to be randomized (800 TTS; 200 placebo). It was assumed 60% would complete 1 year and 80% of these would have evaluable biopsies. Of the 800 randomized to TTS approximately 380 were expected to have evaluable biopsies at 1 year. 380 patients on TTS with evaluable biopsies at 1 year would provide 90% power to rule out an incidence of hyperplasia of 2% using the upper bound of a 2-sided 95% CI.||||1.0000
72397506|NCT00467259|144301427|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|p-value obtained from Fisher's exact test and corresponds to the test of the null hypothesis of no treatment difference.||1000 naturally postmenopausal women not on concomitant E+P therapy at baseline were to be randomized (800 TTS; 200 placebo). It was assumed 60% would complete 1 year and 80% of these would have evaluable biopsies. Of the 800 randomized to TTS approximately 380 were expected to have evaluable biopsies at 1 year. 380 patients on TTS with evaluable biopsies at 1 year would provide 90% power to rule out an incidence of hyperplasia of 2% using the upper bound of a 2-sided 95% CI.||||1.0000
72397507|NCT00467259|144301428|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|p-value obtained from Fisher's Exact test and corresponds to the test of the null hypothesis of no treatment difference.||1000 naturally postmenopausal women not on concomitant E+P therapy at baseline were to be randomized (800 TTS; 200 placebo). It was assumed 60% would complete 1 year and 80% of these would have evaluable biopsies. Of the 800 randomized to TTS approximately 380 were expected to have evaluable biopsies at 1 year. 380 patients on TTS with evaluable biopsies at 1 year would provide 90% power to rule out an incidence of hyperplasia of 2% using the upper bound of a 2-sided 95% CI.||||1.0000
72397508|NCT02056340|144301436|OTHER|||||||0.611||||||Threshold for significaance was p value \<0.05.|Mixed Models Analysis|||We used a linear mixed-effects model which accounted for all measurements taken and the time that those measurements were taken.||||0.611
72397509|NCT02056340|144301437|OTHER|||||||0.029||||||P value reflects baseline to 72 hours between groups. A p-value \<0.05 will be considered significant.|Mixed Models Analysis|||The primary comparison was at 72 hours for the self-reported influenza severity score.||||0.029
72397510|NCT02669433|144301457|SUPERIORITY||Mean Difference (Final Values)|-2.01||||0.158|TWO_SIDED|95.0|-4.8|0.79||The threshold for statistical significance was p=0.05|Mixed Models Analysis||Placebo - active|||0.79|-4.80|0.158
72397511|NCT02669433|144301457|SUPERIORITY||Mean Difference (Final Values)|0.74||||0.6069|TWO_SIDED|95.0|-2.08|3.55||The threshold for statistical significance was p=0.05|Mixed Models Analysis||Placebo - active|||3.55|-2.08|0.6069
72397512|NCT02669433|144301458|SUPERIORITY||Mean Difference (Final Values)|-0.47||||0.6531|TWO_SIDED|95.0|-2.55|1.6|||Mixed Models Analysis||Placebo - active|||1.60|-2.55|0.6531
72397513|NCT02669433|144301458|SUPERIORITY||Mean Difference (Final Values)|0.67||||0.5274|TWO_SIDED|95.0|-1.41|2.75||The threshold for statistical significance was p=0.05|Mixed Models Analysis||Placebo - active|||2.75|-1.41|0.5274
72397514|NCT02669433|144301459|SUPERIORITY||Mean Difference (Final Values)|0.15||||0.3953|TWO_SIDED|95.0|-0.2|0.5||The threshold for statistical significance was p=0.05|Mixed Models Analysis||Placebo - active|||0.5|-0.2|0.3953
72397515|NCT02669433|144301459|SUPERIORITY||Mean Difference (Final Values)|0.07||||0.7008|TWO_SIDED|95.0|-0.28|0.42||The threshold for statistical significance was p=0.05|Mixed Models Analysis||Placebo - active|||0.42|-0.28|0.7008
72397516|NCT00576927|144301461|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.46||||0.655|TWO_SIDED|95.0|0.156|8.717||p-value suspect because of sparse cell counts|Chi-squared|||||8.717|0.156|0.655
72397517|NCT03715764|144301475|SUPERIORITY|||||||0.87||||||Results for the final model, variable GROUP, adjusted for confounders.|Mixed Models Analysis|||||||0.87
72397518|NCT03715764|144301475|SUPERIORITY||||||<|0.001||||||Results for the final model for the variable TIME, adjusted for confounders.|Mixed Models Analysis|||||||<0.001
72397519|NCT03715764|144301475|SUPERIORITY|||||||0.18||||||Results for the final model, variable Group x Time (Statistical interaction of group and time), adjusted for confounders.|Mixed Models Analysis|||||||0.18
72471792|NCT02870972|144466871|SUPERIORITY||Difference in Least Square Means|-0.433||||0.006|TWO_SIDED|95.0|-0.74|-0.127|||ANCOVA|||The primary analysis of treatment-effect was performed using an ANCOVA with the adjusted qualifying attack rate as the covariate.||-0.127|-0.740|0.006
72397520|NCT03715764|144301476|SUPERIORITY|||||||0.56||||||Results for the final model, variable GROUP, adjusted for confounders.|Mixed Models Analysis|||||||0.56
72397521|NCT03715764|144301476|SUPERIORITY|||||||0.0049||||||Results for the final model, variable TIME, adjusted for confounders.|Mixed Models Analysis|||||||0.0049
72397522|NCT03715764|144301476|SUPERIORITY|||||||0.49||||||Results for the final model, adjusted for confounders, for the variable Group x Time (Statistical interaction of group and time).|Mixed Models Analysis|||||||0.49
72397523|NCT03715764|144301477|SUPERIORITY|Used as a confounder in the mixed effect model analysis for primary outcome. All participants enrolled in the study were included in the 12 months analysis.|||||<|0.2||||||Confounding variables with p-values \< 0.2 were carried forward to the final model.|Mixed Models Analysis|||||||<0.2
72397524|NCT03715764|144301478|SUPERIORITY|Used as a confounder in the mixed effect model analysis for primary outcome. All participants enrolled in the study were included in the 12 months analysis.|||||<|0.2||||||Confounding variables with p-values \< 0.2 were carried forward to the final model.|Mixed Models Analysis|||||||<0.2
72397525|NCT00818662|144301483|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-square means|-0.8||||0.476||95.0|-3.1|1.5|||ANCOVA||Results combined from 100 imputations from estimates \& standard errors from 100 ANCOVA results for fixed effect of treatment, E4 allele of apolipoprotein E carrier status, \& continuous covariates age at baseline, baseline ADAS-Cog \& education level|||1.5|-3.1|0.476
72397526|NCT00818662|144301483|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-square means|0.7||||0.53||95.0|-1.6|3.0|||ANCOVA||Results combined from 100 imputations from estimates \& standard errors from 100 ANCOVA results for fixed effect of treatment, E4 allele of apolipoprotein E carrier status, \& continuous covariates age at baseline, baseline ADAS-Cog \& education level|||3.0|-1.6|0.530
72397527|NCT00818662|144301484|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-square means|0.4||||0.812||95.0|-2.9|3.7|||ANCOVA||Results combined from 100 imputations from estimates \& standard errors from 100 ANCOVA results for fixed effect of treatment, E4 allele of apolipoprotein E carrier status, \& continuous covariates age at baseline, baseline ADAS-Cog \& education level|||3.7|-2.9|0.812
72397528|NCT00818662|144301484|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-square means|-0.9||||0.602||95.0|-4.3|2.5|||ANCOVA||Results combined from 100 imputations from estimates \& standard errors from 100 ANCOVA results for fixed effect of treatment, E4 allele of apolipoprotein E carrier status, \& continuous covariates age at baseline, baseline ADAS-Cog \& education level|||2.5|-4.3|0.602
72397529|NCT00818662|144301485|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-square means|-0.7||||0.368||95.0|-2.3|0.8|||ANCOVA||Estimated within a ANCOVA model accounting for the fixed effect of treatment, E4 allele of apolipoprotein E carrier status, and for the continuous covariates age at baseline, baseline ADAS-Cog and education level (in years)|||0.8|-2.3|0.368
72471793|NCT02870972|144466871|SUPERIORITY||Difference in Least Square Means|-0.425||||0.012|TWO_SIDED|95.0|-0.755|-0.095|||ANCOVA|||The primary analysis of treatment-effect was performed using an ANCOVA with the adjusted qualifying attack rate as the covariate.||-0.095|-0.755|0.012
72471794|NCT02870972|144466871|SUPERIORITY||Difference in Least Square Means|-0.703|||<|0.001|TWO_SIDED|95.0|-1.033|0.373|||ANCOVA|||The primary analysis of treatment-effect was performed using an ANCOVA with the adjusted qualifying attack rate as the covariate.||0.373|-1.033|<0.001
72471795|NCT02870972|144466871|SUPERIORITY||Difference in Least Square Means|-0.1||||0.639|TWO_SIDED|95.0|-0.52|0.32|||ANCOVA|||The primary analysis of treatment-effect was performed using an ANCOVA with the adjusted qualifying attack rate as the covariate.||0.32|-0.52|0.639
72471796|NCT02870972|144466872|SUPERIORITY||Difference vs placebo (%)|17.7||||0.155|TWO_SIDED|95.0|-3.4|38.8|||Fisher Exact|||||38.8|-3.4|0.155
72471797|NCT02870972|144466872|SUPERIORITY||Difference vs placebo (%)|16.9||||0.277|TWO_SIDED|95.0|-6.3|40.1|||Fisher Exact|||||40.1|-6.3|0.277
72471798|NCT02870972|144466872|SUPERIORITY||Difference vs placebo (%)|24.0||||0.064|TWO_SIDED|95.0|-1.2|49.2|||Fisher Exact|||||49.2|-1.2|0.064
72471799|NCT02870972|144466872|SUPERIORITY||Difference vs placebo (%)|-4.5||||1|TWO_SIDED|95.0|-13.2|4.2|||Fisher Exact|||||4.2|-13.2|1.000
72471800|NCT02870972|144466872|SUPERIORITY||Difference vs placebo (%)|-16.2||||0.097|TWO_SIDED|95.0|-30.2|-2.2|||Fisher Exact|||||-2.2|-30.2|0.097
72471801|NCT02870972|144466873|SUPERIORITY||Difference in Least Square Means|-0.061||||0.439|TWO_SIDED|95.0|-0.216|0.094|||ANCOVA|||The primary analysis of treatment-effect was performed using an ANCOVA with the adjusted qualifying attack rate as the covariate.||0.094|-0.216|0.439
72471802|NCT02870972|144466873|SUPERIORITY||Difference in Least Square Means|-0.004||||0.968|TWO_SIDED|95.0|-0.198|0.19|||ANCOVA|||The primary analysis of treatment-effect was performed using an ANCOVA with the adjusted qualifying attack rate as the covariate.||0.190|-0.198|0.968
72471803|NCT02870972|144466873|SUPERIORITY||Difference in Least Square Means|-0.045||||0.667|TWO_SIDED|95.0|-0.254|0.164|||ANCOVA|||The primary analysis of treatment-effect was performed using an ANCOVA with the adjusted qualifying attack rate as the covariate.||0.164|-0.254|0.667
72471804|NCT02870972|144466873|SUPERIORITY||Difference in Least Square Means|-0.197||||0.065|TWO_SIDED|95.0|-0.406|0.012|||ANCOVA|||The primary analysis of treatment-effect was performed using an ANCOVA with the adjusted qualifying attack rate as the covariate.||0.012|-0.406|0.065
72471805|NCT02870972|144466873|SUPERIORITY||Difference in Least Square Means|0.035||||0.797|TWO_SIDED|95.0|-0.232|0.301|||ANCOVA|||The primary analysis of treatment-effect was performed using an ANCOVA with the adjusted qualifying attack rate as the covariate.||0.301|-0.232|0.797
72565751|NCT02709486|144662696|SUPERIORITY||Least Square Mean Difference|-0.49|STANDARD_ERROR_OF_MEAN|0.14||0.0006|TWO_SIDED|95.0|-0.77|-0.21|||ANCOVA|||Week 3: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.||-0.21|-0.77|0.0006
72622955|NCT00500331|144776166|OTHER|Tukey's trend test for dose response|||||<|0.001||||||Tukey's trend test adjusts for multiplicity with statistical significance based on p-value \<0.05|ANCOVA|Change=Baseline+Treatment||Placebo, GSK189075 50 mg, GSK189075 100 mg, GSK189075 250 mg||||<0.001
72471806|NCT02870972|144466874|SUPERIORITY||Difference in Least Square Means|-0.364|||<|0.001|TWO_SIDED|95.0|-0.547|-0.181|||ANOVA|||The primary analysis of treatment-effect was performed using an ANCOVA with the adjusted qualifying attack rate as the covariate.||-0.181|-0.547|<0.001
72471807|NCT02870972|144466874|SUPERIORITY||Difference in Least Square Means|-0.384||||0.001|TWO_SIDED|95.0|-0.613|-0.154|||ANCOVA|||The primary analysis of treatment-effect was performed using an ANCOVA with the adjusted qualifying attack rate as the covariate.||-0.154|-0.613|0.001
72471808|NCT02870972|144466874|SUPERIORITY||Difference in Least Square Means|-0.401||||0.002|TWO_SIDED|95.0|-0.647|-0.154|||ANCOVA|||The primary analysis of treatment-effect was performed using an ANCOVA with the adjusted qualifying attack rate as the covariate.||-0.154|-0.647|0.002
72471809|NCT02870972|144466874|SUPERIORITY||Difference in Least Square Means|-0.445|||<|0.001|TWO_SIDED|95.0|-0.692|-0.198|||ANCOVA|||The primary analysis of treatment-effect was performed using an ANCOVA with the adjusted qualifying attack rate as the covariate.||-0.198|-0.692|<0.001
72622956|NCT00500331|144776166|OTHER|Tukey's trend test for dose response|||||<|0.001||||||Tukey's trend test adjusts for multiplicity with statistical significance based on p-value \<0.05|ANCOVA|Change=Baseline+Treatment||Placebo, GSK189075 50 mg, GSK189075 100 mg||||<0.001
72622957|NCT00500331|144776166|OTHER|Tukey's trend test for dose response|||||<|0.001||||||Tukey's trend test adjusts for multiplicity with statistical significance based on p-value \<0.05|ANCOVA|Change=Baseline+Treatment||Placebo, GSK189075 50 mg||||<0.001
72471810|NCT02870972|144466874|SUPERIORITY||Difference in Least Square Means|-0.08||||0.614|TWO_SIDED|95.0|-0.394|0.234|||ANCOVA|||The primary analysis of treatment-effect was performed using an ANCOVA with the adjusted qualifying attack rate as the covariate.||0.234|-0.394|0.614
72471811|NCT02870972|144466875|SUPERIORITY||Difference in Least Square Means|-0.326||||0.006|TWO_SIDED|95.0|-0.557|-0.095|||ANCOVA|||The primary analysis of treatment-effect was performed using an ANCOVA with the terms of treatment and adjusted qualifying attack rate as the covariate.||-0.095|-0.557|0.006
72471812|NCT02870972|144466875|SUPERIORITY||Difference in Least Square Means|-0.293||||0.047|TWO_SIDED|95.0|-0.582|0.004|||ANCOVA|||The primary analysis of treatment-effect was performed using an ANCOVA with the terms of treatment and adjusted qualifying attack rate as the covariate.||0.004|-0.582|0.047
72471813|NCT02870972|144466875|SUPERIORITY||Difference in Least Square Means|-0.327||||0.04|TWO_SIDED|95.0|-0.638|-0.016|||ANCOVA|||The primary analysis of treatment-effect was performed using an ANCOVA with the terms of treatment and adjusted qualifying attack rate as the covariate.||-0.016|-0.638|0.040
72471814|NCT02870972|144466875|SUPERIORITY||Difference in Least Square Means|-0.558|||<|0.001|TWO_SIDED|95.0|-0.87|-0.247|||ANCOVA|||The primary analysis of treatment-effect was performed using an ANCOVA with the terms of treatment and adjusted qualifying attack rate as the covariate.||-0.247|-0.870|<0.001
72622958|NCT00500331|144776166|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.73|||<|0.001|TWO_SIDED|95.0|-1.02|-0.44||Pairwise comparison included for informational purposes and not controlled for multiplicity.|ANCOVA|Change=Baseline+Treatment||Placebo vs. GSK189075 50 mg||-0.44|-1.02|<0.001
72397530|NCT00818662|144301485|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-square means|0.8||||0.319||95.0|-0.8|2.4|||ANCOVA||Estimated within a ANCOVA model accounting for the fixed effect of treatment, E4 allele of apolipoprotein E carrier status, and for the continuous covariates age at baseline, baseline ADAS-Cog and education level (in years)|||2.4|-0.8|0.319
72471815|NCT02870972|144466875|SUPERIORITY||Difference in Least Square Means|0.057||||0.775|TWO_SIDED|95.0|-0.339|0.454|||ANCOVA|||The primary analysis of treatment-effect was performed using an ANCOVA with the terms of treatment and adjusted qualifying attack rate as the covariate.||0.454|-0.339|0.775
72471816|NCT02870972|144466876|SUPERIORITY||Difference in Least Square Means|-4.449||||0.209|TWO_SIDED|95.0|-11.453|2.555|||ANCOVA|||The primary analysis of treatment-effect was performed using an ANCOVA with the terms of treatment and adjusted qualifying attack rate as the covariate.||2.555|-11.453|0.209
72471817|NCT02870972|144466876|SUPERIORITY||Difference in Least Square Means|-9.103||||0.019|TWO_SIDED|95.0|-16.639|-1.567|||ANCOVA|||The primary analysis of treatment-effect was performed using an ANCOVA with the terms of treatment and adjusted qualifying attack rate as the covariate.||-1.567|-16.639|0.019
72471818|NCT02870972|144466876|SUPERIORITY||Difference in Least Square Means|-11.263||||0.004|TWO_SIDED|95.0|-18.808|-3.718|||ANCOVA|||The primary analysis of treatment-effect was performed using an ANCOVA with the terms of treatment and adjusted qualifying attack rate as the covariate.||-3.718|-18.808|0.004
72506170|NCT03918642|144544239|SUPERIORITY||Mean Difference (Net)|1.46|||<|0.001|TWO_SIDED|95.0|0.77|2.15|||Mixed Models Analysis|||||2.15|0.77|<0.001
72506171|NCT03918642|144544240|SUPERIORITY||Mean Difference (Net)|1.24|||<|0.001|TWO_SIDED|95.0|0.62|1.86|||Mixed Models Analysis|||||1.86|0.62|<0.001
72506172|NCT03918642|144544241|SUPERIORITY||Odds Ratio (OR)|21.54|||<|0.001|TWO_SIDED|95.0|4.66|99.56|||Mixed Models Analysis|||||99.56|4.66|<0.001
72506173|NCT03918642|144544242|SUPERIORITY||Odds Ratio (OR)|7.24||||0.006|TWO_SIDED|95.0|1.74|30.06|||Mixed Models Analysis|||||30.06|1.74|0.006
72506174|NCT03918642|144544243|SUPERIORITY||Odds Ratio (OR)|11.77||||0.002|TWO_SIDED|95.0|2.38|58.25|||Mixed Models Analysis|||||58.25|2.38|0.002
72506175|NCT03918642|144544244|SUPERIORITY||Odds Ratio (OR)|6.58||||0.05|TWO_SIDED|95.0|0.99|43.67|||Mixed Models Analysis|||||43.67|0.99|0.05
72506176|NCT03918642|144544245|SUPERIORITY||Odds Ratio (OR)|13.93||||0.06|TWO_SIDED|95.0|0.86|225.44|||Mixed Models Analysis|||||225.44|0.86|0.06
72506177|NCT03918642|144544246|SUPERIORITY||Odds Ratio (OR)|5.61||||0.22|TWO_SIDED|95.0|0.35|89.3|||Mixed Models Analysis|||||89.30|0.35|0.22
72471819|NCT02870972|144466876|SUPERIORITY||Difference in Least Square Means|4.04||||0.405|TWO_SIDED|95.0|-5.586|13.665|||ANCOVA|||The primary analysis of treatment-effect was performed using an ANCOVA with the terms of treatment and adjusted qualifying attack rate as the covariate.||13.665|-5.586|0.405
72471820|NCT02870972|144466877|SUPERIORITY||Difference in Least Square Means|-8.12||||0.135|TWO_SIDED|95.0|-18.826|2.584|||ANCOVA|||The primary analysis of treatment-effect was performed using an ANCOVA with the terms of treatment and adjusted qualifying attack rate as the covariate.||2.584|-18.826|0.135
72471821|NCT02870972|144466877|SUPERIORITY||Difference in Least Square Means|-8.92||||0.121|TWO_SIDED|95.0|-20.26|2.41|||ANCOVA|||The primary analysis of treatment-effect was performed using an ANCOVA with the terms of treatment and adjusted qualifying attack rate as the covariate.||2.410|-20.260|0.121
72471822|NCT02870972|144466877|SUPERIORITY||Difference in Least Square Means|-24.49|||<|0.001|TWO_SIDED|95.0|-35.834|-13.137|||ANOVA|||The primary analysis of treatment-effect was performed using an ANCOVA with the terms of treatment and adjusted qualifying attack rate as the covariate.||-13.137|-35.834|<0.001
72506178|NCT03825042|144544247|SUPERIORITY||Mean Difference (Final Values)|-21.01||||0|TWO_SIDED|95.0|-26.8|-15.2|||ANCOVA|||||-15.20|-26.80|0.0000
72506179|NCT03825042|144544248|SUPERIORITY||Mean Difference (Final Values)|-6.08||||0|TWO_SIDED|95.0|-8.45|-3.61|||ANCOVA|||||-3.61|-8.45|0.0000
72506180|NCT03825042|144544249|SUPERIORITY||Mean Difference (Final Values)|-14.56||||0|TWO_SIDED|95.0|-20.02|-9.11|||ANCOVA|||||-9.11|-20.02|0.0000
72506181|NCT02316470|144544250|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
72506182|NCT02316470|144544250|SUPERIORITY_OR_OTHER|||||||0.0261|||||||Cochran-Mantel-Haenszel|||||||0.0261
72506183|NCT02316470|144544250|SUPERIORITY_OR_OTHER|||||||0.0364|||||||Cochran-Mantel-Haenszel|||||||0.0364
72506184|NCT02316470|144544250|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
72506185|NCT02316470|144544250|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
72506186|NCT02316470|144544250|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
72506187|NCT02316470|144544250|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
72506188|NCT02316470|144544251|SUPERIORITY_OR_OTHER||||||<|0.0001||||||p-value was \<0.0001 at each time point (Day 14, 28, 35, 120, 210)|Fisher-Freeman-Halton Test|||statistical test was applied across all treatment groups at each of the listed time points.||||<0.0001
72506189|NCT02316470|144544252|SUPERIORITY_OR_OTHER||||||<|0.0001||||||p-value was \<0.0001 at each time point (Day 14, 28, 35, 56, 120, 210)|Fisher-Freeman-Halton Test|||statistical test was applied across all treatment groups at each of the listed time points.||||<0.0001
72506190|NCT02316470|144544253|SUPERIORITY_OR_OTHER||||||<|0.0001||||||the p-value was \<0.0001 at each time point (Day 14, 28, 35, 56, 120, 210)|Fisher-Freeman-Halton Test|||statistical test was applied across all treatment groups at each of the listed time points.||||<0.0001
72506191|NCT00500149|144544287|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||The primary efficacy variable will be onset of effect, which will be determined from the results of inferential analyses across multiple time points. No adjustment will be made to the levels of significance as a result of the multiple comparisons.|ANCOVA|Using a linear mixed model that includes sequence, period, and treatment group as fixed effects and subject-within-sequence as a random effect.||Statistical analysis of SKAMP scores at 1.5 hours post-dose||||<0.0001
72506192|NCT00500149|144544287|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0||||The primary efficacy variable will be onset of effect, which will be determined from the results of inferential analyses across multiple time points. No adjustment will be made to the levels of significance as a result of the multiple comparisons.|ANCOVA|Using a linear mixed model that includes sequence, period, and treatment group as fixed effects and subject-within-sequence as a random effect.||Statistical analysis of SKAMP scores at 2.5 hours post-dose||||<0.0001
72565752|NCT02709486|144662696|SUPERIORITY||Least Square Mean Difference|-0.91|STANDARD_ERROR_OF_MEAN|0.15|<|0.0001|TWO_SIDED|95.0|-1.2|-0.62|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.||-0.62|-1.20|<.0001
72565753|NCT02709486|144662696|SUPERIORITY||Least Square Mean Difference|-0.77|STANDARD_ERROR_OF_MEAN|0.15|<|0.0001|TWO_SIDED|95.0|-1.06|-0.47|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.||-0.47|-1.06|<.0001
72471823|NCT02870972|144466877|SUPERIORITY||Difference in Least Square Means|-7.84||||0.284|TWO_SIDED|95.0|-22.316|6.64|||ANCOVA|||The primary analysis of treatment-effect was performed using an ANCOVA with the terms of treatment and adjusted qualifying attack rate as the covariate.||6.640|-22.316|0.284
72565754|NCT02709486|144662696|SUPERIORITY||Least Square Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|0.16|<|0.0001|TWO_SIDED|95.0|-1.2|-0.59|||ANCOVA|||Week 6: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.||-0.59|-1.20|<.0001
72565755|NCT02709486|144662696|SUPERIORITY||Least Square Mean Difference|-0.95|STANDARD_ERROR_OF_MEAN|0.16|<|0.0001|TWO_SIDED|95.0|-1.25|-0.64|||ANCOVA|||Week 6: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.||-0.64|-1.25|<.0001
72565756|NCT02709486|144662696|SUPERIORITY||Least Square Mean Difference|-0.61|STANDARD_ERROR_OF_MEAN|0.16||0.0001|TWO_SIDED|95.0|-0.93|-0.3|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.||-0.30|-0.93|0.0001
72565757|NCT02709486|144662696|SUPERIORITY||Least Square Mean Difference|-0.81|STANDARD_ERROR_OF_MEAN|0.16|<|0.0001|TWO_SIDED|95.0|-1.13|-0.5|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.||-0.50|-1.13|<.0001
72565758|NCT02709486|144662696|SUPERIORITY||Least Square Mean Difference|-0.72|STANDARD_ERROR_OF_MEAN|0.17|<|0.0001|TWO_SIDED|95.0|-1.05|-0.39|||ANCOVA|||Week 10: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.||-0.39|-1.05|<.0001
72471824|NCT02870972|144466878|SUPERIORITY||Difference in Least Square Means|-8.27||||0.067|TWO_SIDED|95.0|-17.132|0.592|||ANCOVA|||The primary analysis of treatment-effect was performed using an ANCOVA with the terms of treatment and adjusted qualifying attack rate as the covariate.||0.592|-17.132|0.067
72471825|NCT02870972|144466878|SUPERIORITY||Difference in Least Square Means|-7.073||||0.136|TWO_SIDED|95.0|-16.432|2.287|||ANCOVA|||The primary analysis of treatment-effect was performed using an ANCOVA with the terms of treatment and adjusted qualifying attack rate as the covariate.||2.287|-16.432|0.136
72471826|NCT02870972|144466878|SUPERIORITY||Difference in Least Square Means|-11.484||||0.015|TWO_SIDED|95.0|-20.642|-2.325|||ANOVA|||The primary analysis of treatment-effect was performed using an ANCOVA with the terms of treatment and adjusted qualifying attack rate as the covariate.||-2.325|-20.642|0.015
72565759|NCT02709486|144662696|SUPERIORITY||Least Square Mean Difference|-0.77|STANDARD_ERROR_OF_MEAN|0.17|<|0.0001|TWO_SIDED|95.0|-1.1|-0.44|||ANCOVA|||Week 10: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.||-0.44|-1.10|<.0001
72565760|NCT02709486|144662696|SUPERIORITY||Least Square Mean Difference|-0.73|STANDARD_ERROR_OF_MEAN|0.17|<|0.0001|TWO_SIDED|95.0|-1.06|-0.39|||ANCOVA|||Week 12: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.||-0.39|-1.06|<.0001
72565761|NCT02709486|144662696|SUPERIORITY||Least Square Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.17|<|0.0001|TWO_SIDED|95.0|-1.13|-0.46|||ANCOVA|||Week 12: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.||-0.46|-1.13|<.0001
72565762|NCT02709486|144662696|SUPERIORITY||Least Square Mean Difference|-0.52|STANDARD_ERROR_OF_MEAN|0.18||0.004|TWO_SIDED|95.0|-0.87|-0.16|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.||-0.16|-0.87|0.0040
72565763|NCT02709486|144662696|SUPERIORITY||Least Square Mean Difference|-0.63|STANDARD_ERROR_OF_MEAN|0.18||0.0005|TWO_SIDED|95.0|-0.98|-0.27|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.||-0.27|-0.98|0.0005
72397531|NCT00818662|144301486|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-square means|0.3||||0.778||95.0|-1.8|2.4|||ANCOVA||Estimated within a ANCOVA model accounting for the fixed effect of treatment, E4 allele of apolipoprotein E carrier status, and for the continuous covariates age at baseline, baseline ADCS-ADL and education level (in years)|||2.4|-1.8|0.778
72397532|NCT00818662|144301486|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-square means|-0.2||||0.851||95.0|-2.3|1.9|||ANCOVA||Estimated within a ANCOVA model accounting for the fixed effect of treatment, E4 allele of apolipoprotein E carrier status, and for the continuous covariates age at baseline, baseline ADCS-ADL and education level (in years)|||1.9|-2.3|0.851
72397533|NCT00818662|144301487|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-square means|0.1||||0.306||95.0|-0.1|0.3|||Mixed Models Analysis|||||0.3|-0.1|0.306
72397534|NCT00818662|144301487|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-square means|0.3||||0.028||95.0|0.0|0.5|||Mixed Models Analysis|||||0.5|0.0|0.028
72397535|NCT00818662|144301488|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-square means|-0.1||||0.66||95.0|-0.3|0.2|||Mixed Models Analysis|||||0.2|-0.3|0.660
72397536|NCT00818662|144301488|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-square means|0.0||||0.766||95.0|-0.2|0.3|||Mixed Models Analysis|||||0.3|-0.2|0.766
72397537|NCT00818662|144301489|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-square means|1.9||||0.206||95.0|-1.0|4.8|||ANCOVA|||||4.8|-1.0|0.206
72397538|NCT00818662|144301489|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-square means|-1.4||||0.331||95.0|-4.3|1.5|||ANCOVA|||||1.5|-4.3|0.331
72471827|NCT02870972|144466878|SUPERIORITY||Difference in Least Square Means|-9.785||||0.114|TWO_SIDED|95.0|-22.001|2.431|||ANCOVA|||The primary analysis of treatment-effect was performed using an ANCOVA with the terms of treatment and adjusted qualifying attack rate as the covariate.||2.431|-22.001|0.114
72397539|NCT00818662|144301490|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-square means|0.7||||0.64||95.0|-2.1|3.4|||ANCOVA|||||3.4|-2.1|0.640
72397540|NCT00818662|144301490|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-square means|2.5||||0.075||95.0|-0.3|5.3|||ANCOVA|||||5.3|-0.3|0.075
72397541|NCT00818662|144301491|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-square means|1.1||||0.093||95.0|-0.2|2.3|||ANCOVA|||||2.3|-0.2|0.093
72397542|NCT00818662|144301491|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-square means|1.1||||0.094||95.0|-0.2|2.3|||ANCOVA|||||2.3|-0.2|0.094
72471828|NCT03738475|144466921|SUPERIORITY|||||||0.0056||||||Based on Wilcoxon Rank Sum test for the change from baseline between treatment groups.|Wilcoxon Rank Sum test|||||||0.0056
72471829|NCT03738475|144466925|SUPERIORITY|||||||0.0799||||||Based on Wilcoxon Rank Sum test for the change from baseline between treatment groups.|Wilcoxon Rank Sum test|||||||0.0799
72471830|NCT03738475|144466927|SUPERIORITY|||||||0.289||||||Based on Wilcoxon Rank Sum test for the change from baseline between treatment groups.|Wilcoxon Rank Sum test|||||||0.2890
72397543|NCT00818662|144301492|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-square means|-1.1||||0.096||95.0|-2.3|0.2|||ANCOVA|||||0.2|-2.3|0.096
72397544|NCT00818662|144301492|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-square means|-1.0||||0.123||95.0|-2.2|0.3|||ANCOVA|||||0.3|-2.2|0.123
72397545|NCT00818662|144301493|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-square means|0.4||||0.167||95.0|-0.2|1.0|||ANCOVA|||||1.0|-0.2|0.167
72397546|NCT00818662|144301493|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-square means|0.0||||0.998||95.0|-0.6|0.6|||ANCOVA|||||0.6|-0.6|0.998
72397547|NCT00818662|144301494|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-square means|0.4||||0.173||95.0|-0.2|0.9|||ANCOVA|||||0.9|-0.2|0.173
72397548|NCT00818662|144301494|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-square means|0.1||||0.744||95.0|-0.4|0.6|||ANCOVA|||||0.6|-0.4|0.744
72397549|NCT00818662|144301495|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-square means|1.5||||0.238||95.0|-1.0|4.0|||ANCOVA|||||4.0|-1.0|0.238
72397550|NCT00818662|144301495|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-square means|-1.1||||0.4||95.0|-3.6|1.4|||ANCOVA|||||1.4|-3.6|0.400
72397551|NCT00818662|144301496|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-square means|-0.6||||0.695||95.0|-3.6|2.4|||ANCOVA|||||2.4|-3.6|0.695
72397552|NCT00818662|144301496|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-square means|-1.3||||0.41||95.0|-4.5|1.9|||ANCOVA|||||1.9|-4.5|0.410
72397553|NCT00818662|144301497|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-square means|0.0||||0.988||95.0|-1.5|1.5|||ANCOVA|||||1.5|-1.5|0.988
72397554|NCT00818662|144301497|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-square means|0.4||||0.555||95.0|-1.0|1.9|||ANCOVA|||||1.9|-1.0|0.555
72397555|NCT00818662|144301498|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-square means|-1.5||||0.783||95.0|-12.2|9.2|||ANCOVA|||||9.2|-12.2|0.783
72397556|NCT00818662|144301498|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-square means|-2.1||||0.7||95.0|-13.1|8.8|||ANCOVA|||||8.8|-13.1|0.700
72397557|NCT00818662|144301499|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-square means|-15.2||||0.191||95.0|-38.0|7.7|||ANCOVA|||||7.7|-38.0|0.191
72397558|NCT00818662|144301499|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-square means|-1.6||||0.892||95.0|-25.4|22.1|||ANCOVA|||||22.1|-25.4|0.892
72397559|NCT00818662|144301500|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-square means|-0.1||||0.588||95.0|-0.4|0.2|||ANCOVA|||||0.2|-0.4|0.588
72397560|NCT00818662|144301500|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-square means|-0.2||||0.351||95.0|-0.5|0.2|||ANCOVA|||||0.2|-0.5|0.351
72397561|NCT01031069|144301558|NON_INFERIORITY|Non-inferiority was defined as the lower limit of the 95% confidence interval (CI) for the ratio of GMTs (Cervarix over Gardasil) being above (\>) 0.5 for HPV-16 type.|Adjusted GMT ratio|2.95|||||TWO_SIDED|95.0|1.92|4.52||||||Adjusted GMT ratios for anti-HPV-16 neutra antibody (ED50): To demonstrate that the immunogenicity of Cervarix vaccine (HIV+/Cervarix Group) was non-inferior to that of Gardasil vaccine (HIV+/Gardasil Group), in terms of geometric mean titers (GMTs) against HPV-16, measured by Pseudovirion-based neutralization assay (PBNA) one month after the administration of the third dose of vaccine in HIV+ subjects.|Primary objectives were to be assessed sequentially: firstly, non-inferiority for both HPV-16 and HPV-18, and then, superiority for HPV-18 followed by superiority for HPV-16.|4.52|1.92|
72471831|NCT01993849|144466993|SUPERIORITY||Mean Difference (Final Values)|0.61||||0.69|TWO_SIDED|95.0|-3.81|2.59||The p-value was calculated, and is not attempting to indicate the threshold for statistical significance.|t-test, 2 sided|||||2.59|-3.81|0.69
72506193|NCT00500149|144544287|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0||||The primary efficacy variable will be onset of effect, which will be determined from the results of inferential analyses across multiple time points. No adjustment will be made to the levels of significance as a result of the multiple comparisons.|ANCOVA|Using a linear mixed model that includes sequence, period, and treatment group as fixed effects and subject-within-sequence as a random effect.||Statistical analysis of SKAMP scores at 5.0 hours post-dose||||<0.0001
72506194|NCT00500149|144544287|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0||||The primary efficacy variable will be onset of effect, which will be determined from the results of inferential analyses across multiple time points. No adjustment will be made to the levels of significance as a result of the multiple comparisons.|ANCOVA|Using a linear mixed model that includes sequence, period, and treatment group as fixed effects and subject-within-sequence as a random effect.||Statistical analysis of SKAMP scores at 7.5 hours post-dose||||<0.0001
72397562|NCT01031069|144301558|NON_INFERIORITY|Non-inferiority was defined as the lower limit of the 95% confidence interval (CI) for the ratio of GMTs (Cervarix over Gardasil) being above (\>) 0.5 for HPV-18 type.|Adjusted GMT ratio|7.83|||||TWO_SIDED|95.0|4.84|12.66||||||Adjusted GMT ratios for anti-HPV-18 neutra antibody (ED50): To demonstrate that the immunogenicity of Cervarix vaccine (HIV+/Cervarix Group) was non-inferior to that of Gardasil vaccine (HIV+/Gardasil Group), in terms of geometric mean titers (GMTs) against HPV-18, measured by Pseudovirion-based neutralization assay (PBNA) one month after the administration of the third dose of vaccine in HIV+ subjects.|Primary objectives were to be assessed sequentially: firstly, non-inferiority for both HPV-16 and HPV-18, and then, superiority for HPV-18 followed by superiority for HPV-16.|12.66|4.84|
72471832|NCT03443414|144466994|OTHER|A fixed-sequence testing approach was used, starting with the highest dose versus placebo. If a statistically significant difference was found at the 2-sided alpha level of 5%, the testing proceeded to the next highest dose.|LS mean difference|0.139|||<|0.001|TWO_SIDED|95.0|0.069|0.21|||MMRM|||Placebo-corrected treatment effect: LS mean difference (RPL554 6.0 mg - Placebo).||0.210|0.069|<0.001
72471833|NCT03443414|144466994|OTHER|A fixed-sequence testing approach was used, starting with the highest dose versus placebo. If a statistically significant difference was found at the 2-sided alpha level of 5%, the testing proceeded to the next highest dose.|LS mean difference|0.2|||<|0.001|TWO_SIDED|95.0|0.131|0.27|||MMRM|||Placebo-corrected treatment effect: LS mean difference (RPL554 3.0 mg - Placebo).||0.270|0.131|<0.001
72471834|NCT03443414|144466994|OTHER|A fixed-sequence testing approach was used, starting with the highest dose versus placebo. If a statistically significant difference was found at the 2-sided alpha level of 5%, the testing proceeded to the next highest dose.|LS mean difference|0.153|||<|0.001|TWO_SIDED|95.0|0.083|0.222|||MMRM|||Placebo-corrected treatment effect: LS mean difference (RPL554 1.5 mg - Placebo).||0.222|0.083|<0.001
72471835|NCT03443414|144466994|OTHER|A fixed-sequence testing approach was used, starting with the highest dose versus placebo. If a statistically significant difference was found at the 2-sided alpha level of 5%, the testing proceeded to the next highest dose.|LS mean difference|0.146|||<|0.001|TWO_SIDED|95.0|0.075|0.216|||MMRM|||Placebo-corrected treatment effect: LS mean difference (RPL554 0.75 mg - Placebo).||0.216|0.075|<0.001
72471836|NCT03443414|144466995|OTHER|A fixed-sequence testing approach was used, starting with the highest dose versus placebo. If a statistically significant difference was found at the 2-sided alpha level of 5%, the testing proceeded to the next highest dose.|LS mean difference|0.002|||=|0.953|TWO_SIDED|95.0|-0.061|0.065|||MMRM|||Placebo-corrected treatment effect: LS mean difference (RPL554 6.0 mg - Placebo).||0.065|-0.061|=0.953
72471837|NCT03443414|144466995|OTHER|A fixed-sequence testing approach was used, starting with the highest dose versus placebo. If a statistically significant difference was found at the 2-sided alpha level of 5%, the testing proceeded to the next highest dose.|LS mean difference|0.068|||=|0.032|TWO_SIDED|95.0|0.006|0.13|||MMRM|||Placebo-corrected treatment effect: LS mean difference (RPL554 3.0 mg - Placebo).||0.130|0.006|=0.032
72471838|NCT03443414|144466995|OTHER|A fixed-sequence testing approach was used, starting with the highest dose versus placebo. If a statistically significant difference was found at the 2-sided alpha level of 5%, the testing proceeded to the next highest dose.|LS mean difference|0.009|||=|0.773|TWO_SIDED|95.0|-0.053|0.072|||MMRM|||Placebo-corrected treatment effect: LS mean difference (RPL554 1.5 mg - Placebo).||0.072|-0.053|=0.773
72471839|NCT03443414|144466995|OTHER|A fixed-sequence testing approach was used, starting with the highest dose versus placebo. If a statistically significant difference was found at the 2-sided alpha level of 5%, the testing proceeded to the next highest dose.|LS mean difference|0.035|||=|0.272|TWO_SIDED|95.0|-0.028|0.099|||MMRM|||Placebo-corrected treatment effect: LS mean difference (RPL554 0.75 mg - Placebo).||0.099|-0.028|=0.272
72471840|NCT03443414|144466996|OTHER|A fixed-sequence testing approach was used, starting with the highest dose versus placebo. If a statistically significant difference was found at the 2-sided alpha level of 5%, the testing proceeded to the next highest dose.|LS mean difference|0.087|||<|0.001|TWO_SIDED|95.0|0.045|0.129|||MMRM|||Placebo-corrected treatment effect: LS mean difference (RPL554 6.0 mg - Placebo) at Day 1.||0.129|0.045|<0.001
72506195|NCT00500149|144544287|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0||||The primary efficacy variable will be onset of effect, which will be determined from the results of inferential analyses across multiple time points. No adjustment will be made to the levels of significance as a result of the multiple comparisons.|ANCOVA|Using a linear mixed model that includes sequence, period, and treatment group as fixed effects and subject-within-sequence as a random effect.||Statistical analysis of SKAMP scores at 10.0 hours post-dose||||<0.0001
72506196|NCT00500149|144544287|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0||||The primary efficacy variable will be onset of effect, which will be determined from the results of inferential analyses across multiple time points. No adjustment will be made to the levels of significance as a result of the multiple comparisons.|ANCOVA|Using a linear mixed model that includes sequence, period, and treatment group as fixed effects and subject-within-sequence as a random effect.||Statistical analysis of SKAMP scores at 12.0 hours post-dose||||<0.0001
72565764|NCT02709486|144662696|SUPERIORITY||Least Square Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.19||0.0002|TWO_SIDED|95.0|-1.06|-0.33|||ANCOVA|||Week 20: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.||-0.33|-1.06|0.0002
72397563|NCT01031069|144301559|SUPERIORITY|Superiority was defined as the lower limit of the 95% CI for the ratio of GMTs (Cervarix over Gardasil) being above 1 for HPV-18 type, with a statistically significant p-value.|Adjusted GMT ratio|7.44|||<|0.0001|TWO_SIDED|95.0|4.79|11.54|||ANOVA|ANOVA model on the log10 transformation of the titers for HIV+ subjects and including the vaccine group as fixed effect.||Adjusted GMT ratios for anti-HPV-18 neutra antibody (ED50): To demonstrate that the immunogenicity of Cervarix vaccine (HIV+/Cervarix Group) was superior to that of Gardasil vaccine (HIV+/Gardasil Group), in terms of geometric mean titers (GMTs) against HPV-18, measured by Pseudovirion-based neutralization assay (PBNA) in HIV+ subjects, assessed following a sequential approach.|Primary objectives were to be assessed sequentially: firstly, non-inferiority for both HPV-16 and HPV-18, and then, superiority for HPV-18 followed by superiority for HPV-16.|11.54|4.79|<0.0001
72397564|NCT01031069|144301559|SUPERIORITY|Superiority was defined as the lower limit of the 95% CI for the ratio of GMTs (Cervarix over Gardasil) being above 1 for HPV-16 type, with a statistically significant p-value.|Adjusted GMT ratio|2.74|||<|0.0001|TWO_SIDED|95.0|1.83|4.11|||ANOVA|ANOVA model on the log10 transformation of the titers for HIV+ subjects and including the vaccine group as fixed effect.||Adjusted GMT ratios for anti-HPV-16 neutra antibody (ED50): To demonstrate that the immunogenicity of Cervarix vaccine (HIV+/Cervarix Group) was superior to that of Gardasil vaccine (HIV+/Gardasil Group), in terms of geometric mean titers (GMTs) against HPV-16, measured by Pseudovirion-based neutralization assay (PBNA) in HIV+ subjects, following a sequential approach.|Primary objectives were to be assessed sequentially: firstly, non-inferiority for both HPV-16 and HPV-18, and then, superiority for HPV-18 followed by superiority for HPV-16.|4.11|1.83|<0.0001
72397565|NCT01031069|144301576|SUPERIORITY|Superiority was defined as the lower limit of the 97.5% CI for the ratio of GMTs (Cervarix over Gardasil) for HPV-18 type being above 1, with a statistically significant p-value.|Adjusted GMT ratio|5.38|||<|0.0001|TWO_SIDED|97.5|3.2|9.06|||ANOVA|ANOVA model on the log10 transformation of the titers for HIV- subjects and including the vaccine group as fixed effect.||Adjusted GMT ratio for anti-HPV-18 neutra antibody (ED50): To demonstrate that the immunogenicity of Cervarix vaccine (HIV-/Cervarix Group) was superior to that of Gardasil vaccine (HIV-/Gardasil Group), in terms of geometric mean titers (GMTs) against HPV-18, measured by Pseudovirion-based neutralization assay (PBNA) in HIV- subjects.||9.06|3.20|<0.0001
72471841|NCT03443414|144466996|OTHER|A fixed-sequence testing approach was used, starting with the highest dose versus placebo. If a statistically significant difference was found at the 2-sided alpha level of 5%, the testing proceeded to the next highest dose.|LS mean difference|0.095|||<|0.001|TWO_SIDED|95.0|0.053|0.137|||MMRM|||Placebo-corrected treatment effect: LS mean difference (RPL554 3.0 mg - Placebo) at Day 1.||0.137|0.053|<0.001
72471842|NCT03443414|144466996|OTHER|A fixed-sequence testing approach was used, starting with the highest dose versus placebo. If a statistically significant difference was found at the 2-sided alpha level of 5%, the testing proceeded to the next highest dose.|LS mean difference|0.07|||=|0.001|TWO_SIDED|95.0|0.028|0.112|||MMRM|||Placebo-corrected treatment effect: LS mean difference (RPL554 1.5 mg - Placebo) at Day 1.||0.112|0.028|=0.001
72471843|NCT03443414|144466996|OTHER|A fixed-sequence testing approach was used, starting with the highest dose versus placebo. If a statistically significant difference was found at the 2-sided alpha level of 5%, the testing proceeded to the next highest dose.|LS mean difference|0.08|||<|0.001|TWO_SIDED|95.0|0.038|0.122|||MMRM|||Placebo-corrected treatment effect: LS mean difference (RPL554 0.75 mg - Placebo) at Day 1.||0.122|0.038|<0.001
72471844|NCT03443414|144466996|OTHER|A fixed-sequence testing approach was used, starting with the highest dose versus placebo. If a statistically significant difference was found at the 2-sided alpha level of 5%, the testing proceeded to the next highest dose.|LS mean difference|0.065|||=|0.048|TWO_SIDED|95.0|0.001|0.129|||MMRM|||Placebo-corrected treatment effect: LS mean difference (RPL554 6.0 mg - Placebo) at Week 4.||0.129|0.001|=0.048
72471845|NCT03443414|144466996|OTHER|A fixed-sequence testing approach was used, starting with the highest dose versus placebo. If a statistically significant difference was found at the 2-sided alpha level of 5%, the testing proceeded to the next highest dose.|LS mean difference|0.119|||<|0.001|TWO_SIDED|95.0|0.055|0.183|||LS mean difference|||Placebo-corrected treatment effect: LS mean difference (RPL554 3.0 mg - Placebo) at Week 4.||0.183|0.055|<0.001
72471846|NCT03443414|144466996|OTHER|A fixed-sequence testing approach was used, starting with the highest dose versus placebo. If a statistically significant difference was found at the 2-sided alpha level of 5%, the testing proceeded to the next highest dose.|LS mean difference|0.085|||=|0.008|TWO_SIDED|95.0|0.022|0.149|||MMRM|||Placebo-corrected treatment effect: LS mean difference (RPL554 1.5 mg - Placebo) at Week 4.||0.149|0.022|=0.008
72506197|NCT00500149|144544287|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0||||The primary efficacy variable will be onset of effect, which will be determined from the results of inferential analyses across multiple time points. No adjustment will be made to the levels of significance as a result of the multiple comparisons.|ANCOVA|Using a linear mixed model that includes sequence, period, and treatment group as fixed effects and subject-within-sequence as a random effect.||Statistical analysis of SKAMP scores at 13.0 hours post-dose||||<0.0001
72506198|NCT00500149|144544288|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||ANCOVA|Using a linear mixed model that includes sequence, period, and treatment group as fixed effects and subject-within-sequence as a random effect.||Statistical analysis of SKAMP scores at 1.5 hours post-dose||||< 0.0001
72565765|NCT02709486|144662696|SUPERIORITY||Least Square Mean Difference|-0.68|STANDARD_ERROR_OF_MEAN|0.19||0.0002|TWO_SIDED|95.0|-1.05|-0.32|||ANCOVA|||Week 20: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.||-0.32|-1.05|0.0002
72622959|NCT00500331|144776166|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.64|||<|0.001|TWO_SIDED|95.0|-0.94|-0.35||Pairwise comparison included for informational purposes and not controlled for multiplicity.|ANCOVA|Change=Baseline+Treatment||Placebo vs. GSK189075 100 mg||-0.35|-0.94|<0.001
72622960|NCT00500331|144776166|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.74|||<|0.001|TWO_SIDED|95.0|-1.03|-0.44||Pairwise comparison included for informational purposes and not controlled for multiplicity.|ANCOVA|Change=Baseline+Treatment||Placebo vs. GSK189075 250 mg||-0.44|-1.03|<0.001
72471847|NCT03443414|144466996|OTHER|A fixed-sequence testing approach was used, starting with the highest dose versus placebo. If a statistically significant difference was found at the 2-sided alpha level of 5%, the testing proceeded to the next highest dose.|LS mean difference|0.072|||=|0.028|TWO_SIDED|95.0|0.008|0.137|||MMRM|||Placebo-corrected treatment effect: LS mean difference (RPL554 0.75 mg - Placebo) at Week 4.||0.137|0.008|=0.028
72471848|NCT02103114|144467013|EQUIVALENCE|T1 (Baseline)||||||0.982|||||||t-test, 2 sided|||||||0.982
72471849|NCT02103114|144467013|EQUIVALENCE|T2 (30 minutes after study drug)|||||<|0.001|||||||t-test, 2 sided|||||||<0.001
72471850|NCT02103114|144467013|EQUIVALENCE|T3 (30 minutes on CPB)||||||0.001|||||||t-test, 2 sided|||||||0.001
72471851|NCT02103114|144467013|EQUIVALENCE|T5 (Arrival in ICU)||||||0.003|||||||t-test, 2 sided|||||||0.003
72471852|NCT02103114|144467013|EQUIVALENCE|T6 (POD 2)||||||0.84|||||||t-test, 2 sided|||||||0.840
72471853|NCT02103114|144467013|EQUIVALENCE|T7 (POD 4)||||||0.475|||||||t-test, 2 sided|||||||0.475
72471854|NCT02103114|144467014|EQUIVALENCE|T4 (just prior to coming off of CPB)||||||0.048|||||||Wilcoxon (Mann-Whitney)|||||||0.048
72471855|NCT02103114|144467015|EQUIVALENCE|T1 (Baseline)||||||0.855|||||||Wilcoxon (Mann-Whitney)|||||||0.855
72471856|NCT02103114|144467015|EQUIVALENCE|T5 (Arrival in ICU)||||||0.225|||||||Wilcoxon (Mann-Whitney)|||||||0.225
72471857|NCT02103114|144467015|EQUIVALENCE|T6 (POD 2)||||||0.313|||||||Wilcoxon (Mann-Whitney)|||||||0.313
72471858|NCT02103114|144467015|EQUIVALENCE|T7 (POD 4)||||||0.008|||||||Wilcoxon (Mann-Whitney)|||||||0.008
72471859|NCT02103114|144467018|EQUIVALENCE|T1 (Baseline) to T5 (Arrival in ICU)||||||0.056|||||||Wilcoxon (Mann-Whitney)|||||||0.056
72471860|NCT02103114|144467019|EQUIVALENCE|T1 (Baseline) to T5 (Arrival in ICU)||||||0.545|||||||Wilcoxon (Mann-Whitney)|||||||0.545
72471861|NCT02103114|144467021|EQUIVALENCE|Baseline (intraoperatively) (Time 1) to before termination of bypass (Time 4)||||||0.757|||||||Wilcoxon (Mann-Whitney)|||||||0.757
72471862|NCT02103114|144467024|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2741|||||||t-test, 2 sided|24 hour postop Fresh Frozen Plasma exposures||||||0.2741
72471863|NCT02103114|144467024|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0351|||||||t-test, 2 sided|24 hour postop Platelet exposures||||||0.0351
72471864|NCT02103114|144467024|SUPERIORITY_OR_OTHER_LEGACY|||||||0.073|||||||t-test, 2 sided|24 hour postop Cryoprecipitate exposures||||||0.073
72471865|NCT02103114|144467024|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0196|||||||t-test, 2 sided|24 hour postop Red Blood Cell exposures||||||0.0196
72471866|NCT02103114|144467025|EQUIVALENCE|protamine time plus 24 hours||||||0.016|||||||Wilcoxon (Mann-Whitney)|||||||0.016
72471867|NCT02103114|144467027|EQUIVALENCE|24 Hours Post-Operatively||||||0.0004|||||||Fisher Exact|||||||0.0004
72471868|NCT02103114|144467028|SUPERIORITY_OR_OTHER_LEGACY|||||||0.927|||||||t-test, 2 sided|||||||0.927
72471869|NCT02103114|144467029|SUPERIORITY_OR_OTHER_LEGACY|||||||0.738|||||||t-test, 2 sided|||||||0.738
72506199|NCT00500149|144544288|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||ANCOVA|Using a linear mixed model that includes sequence, period, and treatment group as fixed effects and subject-within-sequence as a random effect.||Statistical analysis of SKAMP scores at 2.5 hours post-dose||||<0.0001
72506200|NCT00500149|144544288|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||ANCOVA|Using a linear mixed model that includes sequence, period, and treatment group as fixed effects and subject-within-sequence as a random effect.||Statistical analysis of SKAMP scores at 5.0 hours post-dose||||<0.0001
72506201|NCT00500149|144544288|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||ANCOVA|Using a linear mixed model that includes sequence, period, and treatment group as fixed effects and subject-within-sequence as a random effect.||Statistical analysis of SKAMP scores at 7.5 hours post-dose||||<0.0001
72471870|NCT02103114|144467030|SUPERIORITY_OR_OTHER_LEGACY|||||||0.231|||||||Fisher Exact|||||||0.231
72471871|NCT02103114|144467031|SUPERIORITY_OR_OTHER_LEGACY|||||||0.661|||||||Fisher Exact|||||||0.661
72471872|NCT02103114|144467033|SUPERIORITY_OR_OTHER_LEGACY|||||||1|||||||Fisher Exact|||||||1.0
72471873|NCT02103114|144467034|SUPERIORITY_OR_OTHER_LEGACY|||||||0.342|||||||Fisher Exact|||||||0.342
72471874|NCT02103114|144467035|SUPERIORITY_OR_OTHER_LEGACY|||||||0.961|||||||t-test, 2 sided|||||||0.961
72471875|NCT03004404|144467037|OTHER||Slope|0.748|STANDARD_ERROR_OF_MEAN|0.0743|||TWO_SIDED|95.0|0.5959|0.9001|||||Standard error of the mean is actually standard error of the slope. Based on the estimate for the slope parameter, a two sided 95% confidence interval for the slope was computed. Perfect dose proportionality would correspond to a slope of 1.|In the SRD part of the trial, dose proportionality for AUC0-inf was assessed in the 25 mg to 400 mg dose groups (BI 730357 tablets administered under fasted conditions) using a power model (regression model applied to log-transformed data).||0.9001|0.5959|
72471876|NCT03004404|144467037|OTHER||Ratio T/R|118.71|STANDARD_ERROR_OF_MEAN|1.11|||TWO_SIDED|90.0|94.57|149.03|||||Standard error of the mean is the geometric standard error of the mean. The geometric mean ratio was calculated as: tablet 400mg fed1 (T)/400mg fed2(R), T/R.|Relative bioavailability of AUC0-inf for the SRD part was performed to test the effect of food intake on the PK of 400 mg BI 730357 tablets. The intra-individual comparison of fed conditions was done using an Analysis of Variance (ANOVA) model on the logarithmic scale.||149.03|94.57|
72471877|NCT03004404|144467037|OTHER||Geometric mean ratio T1/R (%)|124.79|STANDARD_ERROR_OF_MEAN|1.036|||TWO_SIDED|90.0|116.858|133.255|||||Standard error of the mean is actually geometric standard error of the mean. The geometric mean ratio was calculated as: oral solution in fasted state (test treatment T1)/tablet in fasted state (reference treatment R), T1/R.|Estimation of relative bioavailability of AUC0-inf was based on ANOVA model on the logarithmic scale, included effects: 'sequence', 'period' and 'treatment' as fixed and 'subjects within sequences' as random|Relative bioavailability of BI 730357 for Oral solution (PfOS) fasted (T1) vs. tablet fasted (R) was assessed by the point estimators (geometric means) of the intra-subject ratio of Auc0-inf and their two-sided 90% confidence intervals . No hypothesis was tested.|133.255|116.858|
72471878|NCT03004404|144467037|OTHER||Geometric mean ratio T2/R (%)|125.17|STANDARD_ERROR_OF_MEAN|1.06|||TWO_SIDED|90.0|112.89|138.8|||||Standard error of the mean is actually geometric standard error of the mean. The geometric mean ratio was calculated as: tablet in fed state (test treatment T2)/tablet in fasted state (reference treatment R), T2/R.|Estimation of relative bioavailability of AUC0-inf was based on ANOVA model on the logarithmic scale, included effects: 'sequence', 'period' and 'treatment' as fixed and 'subjects within sequences' as random|Relative bioavailability of BI 730357 for tablet fed (T2) vs. tablet fasted (R) was assessed by the point estimators (geometric means) of the intra-subject ratio of AUC0-inf and their two-sided 90% confidence intervals . No hypothesis was tested.|138.80|112.89|
72506202|NCT00500149|144544288|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||ANCOVA|Using a linear mixed model that includes sequence, period, and treatment group as fixed effects and subject-within-sequence as a random effect.||Statistical analysis of SKAMP scores at 10.0 hours post-dose||||<0.0001
72471879|NCT03004404|144467038|OTHER||Slope|0.7065|STANDARD_ERROR_OF_MEAN|0.0587|||TWO_SIDED|95.0|0.5863|0.8267|||||Standard error of the mean is actually standard error of the slope. Based on the estimate for the slope parameter, a two sided 95% confidence interval for the slope was computed. Perfect dose proportionality would correspond to a slope of 1|In the SRD part of the trial, dose proportionality for Cmax was assessed in the 25 mg to 400 mg dose groups (BI 730357 tablets administered under fasted conditions) using a power model (regression model applied to log-transformed data).||0.8267|0.5863|
72506203|NCT00500149|144544288|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||ANCOVA|Using a linear mixed model that includes sequence, period, and treatment group as fixed effects and subject-within-sequence as a random effect.||Statistical analysis of SKAMP scores at 12.0 hours post-dose||||<0.001
72506204|NCT00500149|144544288|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||ANCOVA|Using a linear mixed model that includes sequence, period, and treatment group as fixed effects and subject-within-sequence as a random effect.||Statistical analysis of SKAMP scores at 13.0 hours post-dose||||<0.0001
72471880|NCT03004404|144467038|OTHER||Ratio T/R|151.22|STANDARD_ERROR_OF_MEAN|1.107|||TWO_SIDED|90.0|122.781|186.248|||||Standard error of the mean is the geometric standard error of the mean. The geometric mean ratio was calculated as: tablet 400mg fed1 (T)/400mg fed2(R), T/R.|Relative bioavailability of the Cmax for the SRD part was performed to test the effect of food intake on the PK of 400 mg BI 730357 tablets. The intra-individual comparison of fed conditions was done using an ANOVA model on the logarithmic scale.||186.248|122.781|
72471881|NCT03004404|144467038|OTHER||Geometric mean ratio T1/R (%)|293.21|STANDARD_ERROR_OF_MEAN|1.069|||TWO_SIDED|90.0|259.044|331.891|||||Standard error of the mean is the geometric standard error of the mean. The geometric mean ratio was calculated as: oral solution in fasted state (test treatment T1)/tablet in fasted state (reference treatment R), T1/R.|Estimation of relative bioavailability of Cmax based on ANOVA model on the logarithmic scale, included effects: 'sequence', 'period' and 'treatment' as fixed and 'subjects within sequences' as random|Relative bioavailability of BI 730357 for Oral solution (PfOS) fasted (T1) vs. tablet fasted (R) was assessed by the point estimators (geometric means) of the intra-subject ratio of Cmax and their two-sided 90% confidence intervals . No hypothesis was tested.|331.891|259.044|
72471882|NCT03004404|144467038|OTHER||Geometric mean ratio T2/R (%)|180.53|STANDARD_ERROR_OF_MEAN|1.059|||TWO_SIDED|90.0|162.369|200.732|||||Standard error of the mean is the geometric standard error of the mean. The geometric mean ratio was calculated as: tablet in fed state (test treatment T2)/tablet in fasted state (reference treatment R), T2/R.|Estimation of relative bioavailability of Cmax was based on ANOVA model on the logarithmic scale, included effects: 'sequence', 'period' and 'treatment' as fixed and 'subjects within sequences' as random|Relative bioavailability of BI 730357 for tablet fasted (T2) vs. tablet fasted (R) was assessed by the point estimators (geometric means) of the intra-subject ratio of Cmax and their two-sided 90% confidence intervals . No hypothesis was tested.|200.732|162.369|
72506205|NCT00521339|144544335|SUPERIORITY_OR_OTHER_LEGACY|||||||0.013|||||||Wilcoxon (Mann-Whitney)|||||||0.013
72506206|NCT00521339|144544336|SUPERIORITY_OR_OTHER_LEGACY|||||||0.074|||||||Wilcoxon (Mann-Whitney)|||||||0.074
72506207|NCT00521339|144544337|SUPERIORITY_OR_OTHER_LEGACY|||||||0.018|||||||Wilcoxon (Mann-Whitney)|||||||0.018
72506208|NCT00521339|144544338|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||||||0.001
72506209|NCT00521339|144544339|SUPERIORITY_OR_OTHER_LEGACY|||||||0.632|||||||Wilcoxon (Mann-Whitney)|||||||0.632
72506210|NCT00521339|144544340|SUPERIORITY_OR_OTHER_LEGACY|||||||0.242|||||||Wilcoxon (Mann-Whitney)|||||||0.242
72506211|NCT00521339|144544341|SUPERIORITY_OR_OTHER_LEGACY|||||||0.329|||||||Wilcoxon (Mann-Whitney)|||||||0.329
72506212|NCT00521339|144544342|SUPERIORITY_OR_OTHER_LEGACY|||||||0.13|||||||Wilcoxon (Mann-Whitney)|||||||0.130
72471883|NCT03933462|144467039|SUPERIORITY|"Categorical preference endpoints that answered at the final visit (e.g., Which device do you prefer?) were analyzed with a One-sample Binomial Test that compared the observed proportion to a 50/50 split."|||||<|0.001|||||||One Sample Binomial|||||||<0.001
72471884|NCT01937975|144467048|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.97|||||TWO_SIDED|90.0|0.87|1.09|||||Geometric Mean Ratio = ESRD HD Day 10 / ESRD Non-HD Day 9|ESRD Non-HD Day 9 versus ESRD HD Day 10||1.09|0.87|
72471885|NCT01937975|144467048|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.85|||||TWO_SIDED|90.0|0.58|1.25|||||Geometric Mean Ratio = ESRD Non-HD Day 9 / Healthy Day 10|ESRD Non-HD Day 9 versus Healthy Participants Day 10||1.25|0.58|
72506213|NCT00521339|144544344|SUPERIORITY_OR_OTHER_LEGACY|||||||0.008|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.008
72506214|NCT00521339|144544345|SUPERIORITY_OR_OTHER_LEGACY|||||||0.031|||||||Wilcoxon (Mann-Whitney)|||||||0.031
72506215|NCT00521339|144544346|SUPERIORITY_OR_OTHER_LEGACY|||||||0.039|||||||Wilcoxon (Mann-Whitney)|||||||0.039
72506216|NCT00521339|144544348|SUPERIORITY_OR_OTHER_LEGACY|||||||0.014|||||||Wilcoxon (Mann-Whitney)|||||||0.014
72506217|NCT00521339|144544349|SUPERIORITY_OR_OTHER_LEGACY|||||||0.015|||||||Wilcoxon (Mann-Whitney)|||||||0.015
72506218|NCT00521339|144544350|SUPERIORITY_OR_OTHER_LEGACY|||||||0.018|||||||Wilcoxon (Mann-Whitney)|||||||0.018
72506219|NCT00521339|144544351|SUPERIORITY_OR_OTHER_LEGACY|||||||0.018|||||||Wilcoxon (Mann-Whitney)|||||||0.018
72506220|NCT00521339|144544352|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
72506221|NCT00521339|144544353|SUPERIORITY_OR_OTHER_LEGACY|||||||0.031|||||||Wilcoxon (Mann-Whitney)|||||||0.031
72506222|NCT00521339|144544354|SUPERIORITY_OR_OTHER_LEGACY|||||||0.217|||||||Wilcoxon (Mann-Whitney)|||||||0.217
72506223|NCT00521339|144544355|SUPERIORITY_OR_OTHER_LEGACY|||||||0.539|||||||Wilcoxon (Mann-Whitney)|||||||0.539
72506224|NCT00521339|144544356|SUPERIORITY_OR_OTHER_LEGACY|||||||0.169|||||||Wilcoxon (Mann-Whitney)|||||||0.169
72506225|NCT00521339|144544357|SUPERIORITY_OR_OTHER_LEGACY|||||||0.339|||||||Wilcoxon (Mann-Whitney)|||||||0.339
72506226|NCT00521339|144544358|SUPERIORITY_OR_OTHER_LEGACY|||||||0.898|||||||Wilcoxon (Mann-Whitney)|||||||0.898
72506227|NCT00521339|144544359|SUPERIORITY_OR_OTHER_LEGACY|||||||0.622|||||||Wilcoxon (Mann-Whitney)|||||||0.622
72506228|NCT00089843|144544370|SUPERIORITY_OR_OTHER_LEGACY||Percent change between 0 and 12 months|3.2|||<|0.0001|TWO_SIDED|95.0|1.8|4.6||This p value was for the effect of Actonel (risedronate) on bone mineral density of the spine.|Factorial analysis|||Factorial analysis||4.6|1.8|<0.0001
72471886|NCT01937975|144467048|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.83|||||TWO_SIDED|90.0|0.56|1.22|||||Geometric Mean Ratio = ESRD HD Day 10 / Healthy Day 10|ESRD HD Day 10 versus Healthy Participants Day 10||1.22|0.56|
72471887|NCT01937975|144467048|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.65|||||TWO_SIDED|90.0|1.09|2.49|||||Geometric Mean Ratio = SRI Day 10 / Healthy Day 10|SRI Participants Day 10 versus Healthy Participants Day 10||2.49|1.09|
72471888|NCT01937975|144467049|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.98|||||TWO_SIDED|90.0|0.81|1.19|||||Geometric Mean Ratio = ESRD HD Day 10 / ESRD Non-HD Day 9|ESRD Non-HD Day 9 versus ESRD HD Day 10||1.19|0.81|
72471889|NCT01937975|144467049|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.79|||||TWO_SIDED|90.0|0.54|1.16|||||Geometric Mean Ratio = ESRD Non-HD Day 9 / Healthy Day 10|ESRD Non-HD Day 9 versus Healthy Participants Day 10||1.16|0.54|
72471890|NCT01937975|144467049|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.78|||||TWO_SIDED|90.0|0.53|1.14|||||Geometric Mean Ratio = ESRD HD Day 10 / Healthy Day 10|ESRD HD Day 10 versus Healthy Participants Day 10||1.14|0.53|
72471891|NCT01937975|144467049|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.6|||||TWO_SIDED|90.0|1.06|2.42|||||Geometric Mean Ratio = SRI Day 10 / Healthy Day 10|SRI Participants Day 10 versus Healthy Participants Day 10||2.42|1.06|
72471892|NCT01937975|144467050|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.96|||||TWO_SIDED|90.0|0.75|1.22|||||Geometric Mean Ratio = ESRD HD Day 10 / ESRD Non-HD Day 9|ESRD Non-HD Day 9 versus ESRD HD Day 10||1.22|0.75|
72471893|NCT01937975|144467050|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.92|||||TWO_SIDED|90.0|0.57|1.48|||||Geometric Mean Ratio = ESRD Non-HD Day 9 / Healthy Day 10|ESRD Non-HD Day 9 versus Healthy Participants Day 10||1.48|0.57|
72471894|NCT01937975|144467050|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.88|||||TWO_SIDED|90.0|0.54|1.42|||||Geometric Mean Ratio = ESRD HD Day 10 / Healthy Day 10|ESRD HD Day 10 versus Healthy Participants Day 10||1.42|0.54|
72471895|NCT01937975|144467050|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.66|||||TWO_SIDED|90.0|0.99|2.77|||||Geometric Mean Ratio = SRI Day 10 / Healthy Day 10|SRI Participants Day 10 versus Healthy Participants Day 10||2.77|0.99|
72471896|NCT01937975|144467053|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.03|||||TWO_SIDED|90.0|0.92|1.15|||||Geometric Mean Ratio = ESRD HD Day 10 / ESRD Non-HD Day 9|ESRD Non-HD Day 9 versus ESRD HD Day 10||1.15|0.92|
72471897|NCT01937975|144467053|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.18|||||TWO_SIDED|90.0|0.8|1.73|||||Geometric Mean Ratio = ESRD Non-HD Day 9 / Healthy Day 10|ESRD Non-HD Day 9 versus Healthy Participants Day 10||1.73|0.80|
72471898|NCT01937975|144467053|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.21|||||TWO_SIDED|90.0|0.82|1.78|||||Geometric Mean Ratio = ESRD HD Day 10 / Healthy Day 10|ESRD HD Day 10 versus Healthy Participants Day 10||1.78|0.82|
72471899|NCT01937975|144467053|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.61|||||TWO_SIDED|90.0|0.4|0.92|||||Geometric Mean Ratio = SRI Day 10 / Healthy Day 10|SRI Participants Day 10 versus Healthy Participants Day 10||0.92|0.40|
72471900|NCT01937975|144467054|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.94|||||TWO_SIDED|90.0|0.63|1.42|||||Geometric Mean Ratio = ESRD HD Day 10 / Healthy Day 10|||1.42|0.63|
72471901|NCT01937975|144467054|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.61|||||TWO_SIDED|90.0|0.39|0.94|||||Geometric Mean Ratio = SRI Day 10 / Healthy Day 10|||0.94|0.39|
72471902|NCT01937975|144467055|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.14|||||TWO_SIDED|90.0|1.08|1.21|||||Geometric Mean Ratio = ESRD HD Day 10 / ESRD Non-HD Day 9|ESRD Non-HD Day 9 versus ESRD HD Day 10||1.21|1.08|
72471903|NCT01937975|144467055|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.86|||||TWO_SIDED|90.0|0.65|1.14|||||Geometric Mean Ratio = ESRD Non-HD Day 9 / Healthy Day 10|ESRD Non-HD Day 9 versus Healthy Participants Day 10||1.14|0.65|
72471904|NCT01937975|144467055|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.99|||||TWO_SIDED|90.0|0.75|1.3|||||Geometric Mean Ratio = ESRD HD Day 10 / Healthy Day 10|ESRD HD Day 10 versus Healthy Participants Day 10||1.30|0.75|
72471905|NCT01937975|144467055|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.86|||||TWO_SIDED|90.0|1.38|2.51|||||Geometric Mean Ratio = SRI Day 10 / Healthy Day 10|SRI Participants Day 10 versus Healthy Participants Day 10||2.51|1.38|
72471906|NCT01937975|144467056|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.24|||||TWO_SIDED|90.0|1.17|1.32|||||Geometric Mean Ratio = ESRD HD Day 10 / ESRD Non-HD Day 9|ESRD Non-HD Day 9 versus ESRD HD Day 10||1.32|1.17|
72471907|NCT01937975|144467056|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.77|||||TWO_SIDED|90.0|0.56|1.06|||||Geometric Mean Ratio = ESRD Non-HD Day 9 / Healthy Day 10|ESRD Non-HD Day 9 versus Healthy Participants Day 10||1.06|0.56|
72471908|NCT01937975|144467056|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.95|||||TWO_SIDED|90.0|0.69|1.32|||||Geometric Mean Ratio = ESRD HD Day 10 / Healthy Day 10|ESRD HD Day 10 versus Healthy Participants Day 10||1.32|0.69|
72471909|NCT01937975|144467056|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|2.07|||||TWO_SIDED|90.0|1.46|2.93|||||Geometric Mean Ratio = SRI Day 10 / Healthy Day 10|SRI Participants Day 10 versus Healthy Participants Day 10||2.93|1.46|
72471910|NCT01937975|144467057|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.12|||||TWO_SIDED|90.0|1.0|1.26|||||Geometric Mean Ratio = ESRD HD Day 10 / ESRD Non-HD Day 9|ESRD Non-HD Day 9 versus ESRD HD Day 10||1.26|1.00|
72471911|NCT01937975|144467057|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.84|||||TWO_SIDED|90.0|0.62|1.13|||||Geometric Mean Ratio = ESRD Non-HD Day 9 / Healthy Day 10|ESRD Non-HD Day 9 versus Healthy Participants Day 10||1.13|0.62|
72471912|NCT01937975|144467057|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.94|||||TWO_SIDED|90.0|0.7|1.27|||||Geometric Mean Ratio = ESRD HD Day 10 / Healthy Day 10|ESRD HD Day 10 versus Healthy Participants Day 10||1.27|0.70|
72471913|NCT01937975|144467057|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.66|||||TWO_SIDED|90.0|1.21|2.28|||||Geometric Mean Ratio = SRI Day 10 / Healthy Day 10|SRI Participants Day 10 versus Healthy Participants Day 10||2.28|1.21|
72471914|NCT01937975|144467060|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.88|||||TWO_SIDED|90.0|0.83|0.92|||||Geometric Mean Ratio = ESRD HD Day 10 / ESRD Non-HD Day 9|ESRD Non-HD Day 9 versus ESRD HD Day 10||0.92|0.83|
72471915|NCT01937975|144467060|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.16|||||TWO_SIDED|90.0|0.88|1.53|||||Geometric Mean Ratio = ESRD Non-HD Day 9 / Healthy Day 10|ESRD Non-HD Day 9 versus Healthy Participants Day 10||1.53|0.88|
72471916|NCT01937975|144467060|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.01|||||TWO_SIDED|90.0|0.77|1.34|||||Geometric Mean Ratio = ESRD HD Day 10 / Healthy Day 10|ESRD HD Day 10 versus Healthy Participants Day 10||1.34|0.77|
72471917|NCT01937975|144467060|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.54|||||TWO_SIDED|90.0|0.4|0.72|||||Geometric Mean Ratio = SRI Day 10 / Healthy Day 10|SRI Participants Day 10 versus Healthy Participants Day 10||0.72|0.40|
72471918|NCT01937975|144467061|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.95|||||TWO_SIDED|90.0|0.7|1.3|||||Geometric Mean Ratio = ESRD HD Day 10 / Healthy Day 10|||1.30|0.70|
72397566|NCT01031069|144301576|SUPERIORITY|Superiority was defined as the lower limit of the 97.5% CI for the ratio of GMTs (Cervarix over Gardasil) for HPV-16 type being above 1, with a statistically significant p-value.|Adjusted GMT ratio|3.05|||<|0.0001|TWO_SIDED|97.5|1.84|5.06|||ANOVA|ANOVA model on the log10 transformation of the titers for HIV- subjects and including the vaccine group as fixed effect.||Adjusted GMT ratio for anti-HPV-16 neutra antibody (ED50): To demonstrate that the immunogenicity of Cervarix vaccine (HIV-/Cervarix Group) was superior to that of Gardasil vaccine (HIV-/Gardasil Group), in terms of geometric mean titers (GMTs) against HPV-16, measured by Pseudovirion-based neutralization assay (PBNA) in HIV- subjects.||5.06|1.84|<0.0001
72397567|NCT01103284|144301591|SUPERIORITY_OR_OTHER|||||||0.33||||||The a priori threshold for statistical significance was 0.05|Mixed Models Analysis|The Mixed-Effect Model Repeated Measure (MMRM) was adjusted for the following baseline covariates: age, C-peptide, insulin dose by body weight and AUC||||||0.33
72397568|NCT01103284|144301592|SUPERIORITY_OR_OTHER|||||||0.68|TWO_SIDED|||||A priori threshold for statistical significance was 0.05|Mixed Models Analysis|The MMRM model was adjusted for the following covariates: age, Baseline C-peptide, Baseline insulin dose adjusted for body weight, and Baseline AUC.||||||0.68
72397569|NCT01103284|144301593|SUPERIORITY_OR_OTHER|||||||0.44|TWO_SIDED|||||The a priori threshold for statistical significance was 0.05|Mixed Models Analysis|The MMRM model was adjusted for the following covariates: age, Baseline C-peptide, Baseline insulin dose adjusted for body weight, and Baseline AUC||||||0.44
72506229|NCT00089843|144544370|SUPERIORITY_OR_OTHER_LEGACY||Percent change between 0 and 12 months|-0.6||||0.41|TWO_SIDED|95.0|-2.0|0.8||This p value was for the effect of testosterone on bone mineral density of the spine.|Factorial analysis|||Factorial analysis||0.8|-2.0|0.41
72471919|NCT01937975|144467061|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.63|||||TWO_SIDED|90.0|0.45|0.89|||||Geometric Mean Ratio = SRI Day 10 / Healthy Day 10|||0.89|0.45|
72471920|NCT04692467|144467070|SUPERIORITY||Mean Difference (Final Values)|-5.88|||<|0.0001|TWO_SIDED|95.0|-8.77|-3.01|||Mixed Models Analysis||The mean difference reflects the difference in mean change (i.e., mean change = 12 months minus baseline for each arm) between the intervention arm and SOC arm (direction = intervention arm minus SOC arm).|||-3.01|-8.77|<0.0001
72471921|NCT00422734|144467089|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Hypotheses were tested in a sequential fashion using a gatekeeping strategy and adjusted for multiplicity. Statistical significance at 0.05 level was required for this variable|ANCOVA|Change from baseline ANCOVA model: treatment group, baseline value, pooled site. Baseline-by-treatment interaction included if interaction at p\<0.10.||The null hypotheses (no treatment effect with respect to IIEF EF domain or SEP2 or SEP3) were each tested at a specified level of 0.05. In order to pass a serial gatekeeper, it was necessary to reject all three hypotheses. The two null hypotheses (no treatment effect with respect to subject SLQQ-SQoL domain and no treatment effect with respect to partner SLQQ-SQoL domain) were then each tested at a significance level of 0.025.||||<0.001
72471922|NCT00422734|144467090|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Subject. Hypotheses were tested in a sequential fashion using a gatekeeping strategy and adjusted for multiplicity. To adjust for multiplicity, statistical significance at 0.025 level was required for this variable.|ANCOVA|Change from baseline ANCOVA model: treatment group, baseline value, pooled site. Baseline-by-treatment interaction included if interaction at p\<0.10.||The null hypotheses (no treatment effect with respect to IIEF EF domain or SEP2 or SEP3) were each tested at a specified level of 0.05. In order to pass a serial gatekeeper, it was necessary to reject all three hypotheses. The two null hypotheses (no treatment effect with respect to subject SLQQ-SQoL domain and no treatment effect with respect to partner SLQQ-SQoL domain) were then each tested at a significance level of 0.025.||||<0.001
72471923|NCT00422734|144467090|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Partner. Hypotheses were tested in a sequential fashion using a gatekeeping strategy and adjusted for multiplicity. To adjust for multiplicity, statistical significance at 0.025 level was required for this variable.|ANCOVA|Change from baseline ANCOVA model: treatment group, baseline value, pooled site. Baseline-by-treatment interaction included if interaction at p\<0.10.||The null hypotheses (no treatment effect with respect to IIEF EF domain or SEP2 or SEP3) were each tested at a specified level of 0.05. In order to pass a serial gatekeeper, it was necessary to reject all three hypotheses. The two null hypotheses (no treatment effect with respect to subject SLQQ-SQoL domain and no treatment effect with respect to partner SLQQ-SQoL domain) were then each tested at a significance level of 0.025.||||<0.001
72471924|NCT00422734|144467091|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|Change from baseline ANCOVA model: treatment group, baseline value, pooled site. Baseline-by-treatment interaction included if interaction at p\<0.10.||||||<0.001
72471925|NCT00422734|144467092|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|Change from baseline ANCOVA model: treatment group, baseline value, pooled site. Baseline-by-treatment interaction included if interaction at p\<0.10.||||||<0.001
72506230|NCT00089843|144544371|SUPERIORITY_OR_OTHER_LEGACY||Percent change between 0 and 12 months|-41.0||||0.002|TWO_SIDED|95.0||||This p value was for the effect of Actonel (risedronate).|Factorial analysis|||Factorial analysis||||0.002
72506231|NCT00089843|144544371|SUPERIORITY_OR_OTHER_LEGACY||Percent change between 0 and 12 months|-11.0||||0.39||95.0||||This p value was for the effect of testosterone.|Factorial analysis|||Factorial analysis||||0.39
72506232|NCT03626415|144544374|OTHER|The ratio and 90% confidence interval were expressed as percentages.|Ratio of Adjusted Geometric Mean|94.4|||||TWO_SIDED|90.0|62.96|141.55|||ANOVA|||Mild Hepatic Impairment (Test) versus Normal Hepatic Function (Reference)||141.55|62.96|
72506233|NCT03626415|144544374|OTHER|The ratio and 90% confidence interval were expressed as percentages.|Ratio of Adusted Geometric Means|105.53|||||TWO_SIDED|90.0|70.38|158.24|||ANOVA|||Moderate Hepatic Impairment (Test) versus Normal Hepatic Function (Reference)||158.24|70.38|
72506234|NCT03626415|144544375|OTHER|The ratio and 90% confidence interval were expressed as percentages.|Ratio of Adjusted Geometric Means|133.33|||||TWO_SIDED|90.0|86.17|206.28|||ANOVA|||Mild Hepatic Impairment (Test) versus Normal Hepatic Function (Reference)||206.28|86.17|
72506235|NCT03626415|144544375|OTHER|The ratio and 90% confidence interval were expressed as percentages.|Ratio of Adjusted Geometric Mean|153.99|||||TWO_SIDED|90.0|99.52|238.25|||ANOVA|||Moderate Hepatic Impairment (Test) versus Normal Hepatic Function (Reference)||238.25|99.52|
72506236|NCT03626415|144544376|OTHER|The ratio and 90% confidence interval were expressed as percentages.|Ratio of Adjusted Geometric Means|75.94|||||TWO_SIDED|90.0|57.39|100.47|||ANOVA|||Mild Hepatic Impairment (Test) versus Normal Hepatic Function (Reference)||100.47|57.39|
72471926|NCT00422734|144467093|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value is for subject scores|ANCOVA|ANCOVA included:treatment, baseline value of IIEF EF Domain, pooled site. Baseline-value-by-treatment interaction included if interaction at p\<0.10||||||<0.001
72506237|NCT03626415|144544376|OTHER|The ratio and 90% confidence interval were expressed as percentages.|Ratio of Adjusted Geometric Means|84.14|||||TWO_SIDED|90.0|63.59|111.33|||ANOVA|||Moderate Hepatic Impairment (Test) versus Normal Hepatic Function (Reference)||111.33|63.59|
72622961|NCT00500331|144776166|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.9|||<|0.001|TWO_SIDED|95.0|-1.19|-0.61||Pairwise comparison included for informational purposes and not controlled for multiplicity.|ANCOVA|Change=Baseline+Treatment||Placebo vs. GSK189075 500 mg||-0.61|-1.19|<0.001
72471927|NCT00422734|144467093|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value is for partner scores|ANCOVA|ANCOVA included:treatment, baseline value of IIEF EF Domain, pooled site. Baseline-value-by-treatment interaction included if interaction at p\<0.10||||||<0.001
72471928|NCT00422734|144467094|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for SEP Question 2. Hypotheses were tested in a sequential fashion using a gatekeeping strategy and adjusted for multiplicity. Statistical significance at 0.05 level was required for this variable.|ANCOVA|Change from baseline ANCOVA model: treatment group, baseline value, pooled site. Baseline-by-treatment interaction included if interaction at p\<0.10.||The null hypotheses (no treatment effect with respect to IIEF EF domain or SEP2 or SEP3) were each tested at a specified level of 0.05. In order to pass a serial gatekeeper, it was necessary to reject all three hypotheses. The two null hypotheses (no treatment effect with respect to subject SLQQ-SQoL domain and no treatment effect with respect to partner SLQQ-SQoL domain) were then each tested at a significance level of 0.025.||||<0.001
72471929|NCT00422734|144467094|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for SEP Question 3. Hypotheses were tested in a sequential fashion using a gatekeeping strategy and adjusted for multiplicity. Statistical significance at 0.05 level was required for this variable.|ANCOVA|Change from baseline ANCOVA model: treatment group, baseline value, pooled site. Baseline-by-treatment interaction included if interaction at p\<0.10.||The null hypotheses (no treatment effect with respect to IIEF EF domain or SEP2 or SEP3) were each tested at a specified level of 0.05. In order to pass a serial gatekeeper, it was necessary to reject all three hypotheses. The two null hypotheses (no treatment effect with respect to subject SLQQ-SQoL domain and no treatment effect with respect to partner SLQQ-SQoL domain) were then each tested at a significance level of 0.025.||||<0.001
72471930|NCT00422734|144467095|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value for SEP Question 4|ANCOVA|Change from baseline ANCOVA model: treatment group, baseline value, pooled site. Baseline-by-treatment interaction included if interaction at p\<0.10.||||||<0.001
72471931|NCT00422734|144467095|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value for SEP Question 5|ANCOVA|Change from baseline ANCOVA model: treatment group, baseline value, pooled site. Baseline-by-treatment interaction included if interaction at p\<0.10.||||||<0.001
72471932|NCT00422734|144467096|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|Change from baseline ANCOVA model: treatment group, baseline value, pooled site. Baseline-by-treatment interaction included if interaction at p\<0.10.||||||<0.001
72471933|NCT00422734|144467097|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|Change from baseline ANCOVA model: treatment group, baseline value, pooled site. Baseline-by-treatment interaction included if interaction at p\<0.10.||||||<0.001
72471934|NCT00422734|144467098|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for GAQ Question 1|Regression, Logistic|Model included:treatment, baseline value of IIEF EF Domain, pooled site. Baseline-value-by-treatment interaction included if interaction at p\<0.10||||||<0.001
72471935|NCT00422734|144467098|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for GAQ Question 2|Regression, Logistic|Model included:treatment, baseline value of IIEF EF Domain, pooled site. Baseline-value-by-treatment interaction included if interaction at p\<0.10||||||<0.001
72471936|NCT00422734|144467099|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for GAQ Question 1|Regression, Logistic|Model included:treatment, baseline value of IIEF EF Domain, pooled site. Baseline-value-by-treatment interaction included if interaction at p\<0.10||||||<0.001
72471937|NCT00422734|144467099|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for GAQ Question 2|Regression, Logistic|Model included:treatment, baseline value of IIEF EF Domain, pooled site. Baseline-value-by-treatment interaction included if interaction at p\<0.10||||||<0.001
72471938|NCT00422734|144467100|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for SEP Question 1|ANCOVA|Change from baseline ANCOVA model: treatment group, baseline value, pooled site. Baseline-by-treatment interaction included if interaction at p\<0.10.||||||<0.001
72471939|NCT00422734|144467100|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for SEP Question 2|ANCOVA|Change from baseline ANCOVA model: treatment group, baseline value, pooled site. Baseline-by-treatment interaction included if interaction at p\<0.10.||||||<0.001
72471940|NCT00422734|144467101|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for SEAR Total Score|ANCOVA|Change from baseline ANCOVA model: treatment group, baseline value, pooled site. Baseline-by-treatment interaction included if interaction at p\<0.10.||||||<0.001
72471941|NCT00422734|144467101|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for SEAR Sexual Relationship|ANCOVA|Change from baseline ANCOVA model: treatment group, baseline value, pooled site. Baseline-by-treatment interaction included if interaction at p\<0.10.||||||<0.001
72471942|NCT00422734|144467101|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for SEAR Confidence|ANCOVA|Change from baseline ANCOVA model: treatment group, baseline value, pooled site. Baseline-by-treatment interaction included if interaction at p\<0.10.||||||<0.001
72471943|NCT00422734|144467102|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for SEAR Self-Esteem|ANCOVA|Change from baseline ANCOVA model: treatment group, baseline value, pooled site. Baseline-by-treatment interaction included if interaction at p\<0.10.||||||<0.001
72506238|NCT03626415|144544377|OTHER|The ratio and 90% confidence interval were expressed as percentages.|Ratio of Adjusted Geometric Means|95.74|||||TWO_SIDED|90.0|72.71|126.08|||ANOVA|||Mild Hepatic Impairment (Test) versus Normal Hepatic Function (Reference)||126.08|72.71|
72506239|NCT03626415|144544377|OTHER|The ratio and 90% confidence interval were expressed as percentages.|Ratio of Adjusted Geometric Means|114.82|||||TWO_SIDED|90.0|87.19|151.2|||ANOVA|||Moderate Hepatic Impairment (Test) versus Normal Hepatic Function (Reference)||151.20|87.19|
72622962|NCT00500331|144776166|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.07|||<|0.001|TWO_SIDED|95.0|-1.36|-0.77||Pairwise comparison included for informational purposes and not controlled for multiplicity.|ANCOVA|Change=Baseline+Treatment||Placebo vs. GSK189075 1000 mg||-0.77|-1.36|<0.001
72506240|NCT00859898|144544382|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.53|STANDARD_ERROR_OF_MEAN|0.1056|<|0.0001|TWO_SIDED|95.0|-0.74|-0.32||Dapagliflozin 10 mg plus metformin XR treatment group had to be superior to both monotherapy treatment groups to be considered significant. Two-sided significance level at α=0.05|ANCOVA|treatment group as an effect and the baseline HbA1c value as a covariate.||||-0.32|-0.74|<0.0001
72506241|NCT00859898|144544382|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.54|STANDARD_ERROR_OF_MEAN|0.1072|<|0.0001|TWO_SIDED|95.0|-0.75|-0.33||Dapagliflozin 10 mg plus metformin XR treatment group had to be superior to both monotherapy treatment groups to be considered significant. Two-sided significance level at α=0.05|ANCOVA|treatment group as an effect and the baseline HbA1c value as a covariate.||||-0.33|-0.75|<0.0001
72506242|NCT00859898|144544382|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority of dapagliflozin 10 mg versus metformin XR was demonstrated when the upper limit of the two-sided 95% confidence interval of the difference in change in HbA1c from baseline to Week 24 (LOCF) between dapagliflozin 10 mg and metformin XR was less than 0.35%.|Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.1054|||TWO_SIDED|95.0|-0.22|0.2|||ANCOVA|treatment group as an effect and the baseline value as a covariate||||0.20|-0.22|
72506243|NCT00859898|144544382|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.1054||0.9144|TWO_SIDED|95.0|-0.22|0.2||two-sided significance level at α=0.05|ANCOVA|treatment group as an effect and the baseline HbA1c value as a covariate.||When testing for superiority, significance is claimed only if dapagliflozin 10 mg is superior to metformin XR||0.20|-0.22|0.9144
72506244|NCT00859898|144544383|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.9|STANDARD_ERROR_OF_MEAN|3.558|<|0.0001|TWO_SIDED|95.0|-20.9|-7.0||two-sided significance level at α=0.05. Dapagliflozin 10 mg plus metformin XR treatment group had to be superior to both monotherapy treatment groups to be considered significant.|ANCOVA|treatment group as an effect and the baseline value as a covariate.||A hierarchical closed testing procedure was implemented to control the familywise type I error rate related to this endpoint at the two-sided 0.05 level. Statistical tests were only performed for a given secondary endpoint if all previous sequential tests versus that treatment group were also significant.||-7.0|-20.9|<0.0001
72506245|NCT00859898|144544383|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-25.5|STANDARD_ERROR_OF_MEAN|3.59|<|0.0001|TWO_SIDED|95.0|-32.6|-18.5||two-sided significance level at α=0.05. Dapagliflozin 10 mg plus metformin XR treatment group had to be superior to both monotherapy treatment groups to be considered significant.|ANCOVA|treatment group as an effect and the baseline value as a covariate.||A hierarchical closed testing procedure was implemented to control the familywise type I error rate related to this endpoint at the two-sided 0.05 level. Statistical tests were only performed for a given secondary endpoint if all previous sequential tests versus that treatment group were also significant.||-18.5|-32.6|<0.0001
72506246|NCT00859898|144544383|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority of dapagliflozin 10 mg versus metformin XR was demonstrated when the upper limit of the two-sided 95% confidence interval of the difference in change FPG from baseline to Week 24 (LOCF) between dapagliflozin 10 mg and metformin XR was less than 15 mg/dL.|Mean Difference (Final Values)|-11.6|STANDARD_ERROR_OF_MEAN|3.566|||TWO_SIDED|95.0|-18.6|-4.6|||ANCOVA|treatment group as an effect and the baseline value as a covariate||||-4.6|-18.6|
72565766|NCT02709486|144662696|SUPERIORITY||Least Square Mean Difference|-0.39|STANDARD_ERROR_OF_MEAN|0.2||0.0506|TWO_SIDED|95.0|-0.78|0.0|||ANCOVA|||Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.||0.00|-0.78|0.0506
72565767|NCT02709486|144662696|SUPERIORITY||Least Square Mean Difference|-0.52|STANDARD_ERROR_OF_MEAN|0.2||0.0086|TWO_SIDED|95.0|-0.91|-0.13|||ANCOVA|||Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.||-0.13|-0.91|0.0086
72565768|NCT02709486|144662698|SUPERIORITY||Least Square Mean Difference|-0.77|STANDARD_ERROR_OF_MEAN|0.15|<|0.0001|TWO_SIDED|95.0|-1.07|-0.48|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC stiffness subscales and baseline diary average pain as covariates, and study site as a random effect.||-0.48|-1.07|<.0001
72506247|NCT00859898|144544383|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.6|STANDARD_ERROR_OF_MEAN|3.566||0.0012|TWO_SIDED|95.0|-18.6|-4.6||two-sided significance level at α=0.05.|ANCOVA|treatment group as an effect and the baseline value as a covariate.||When testing for superiority, significance is claimed only if dapagliflozin 10 mg is superior to metformin XR||-4.6|-18.6|0.0012
72506248|NCT00859898|144544384|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.9|STANDARD_ERROR_OF_MEAN|4.598||0.0012|TWO_SIDED|95.0|5.9|23.9||Dapagliflozin 10 mg plus metformin XR treatment group had to be superior to both monotherapy treatment groups to be considered significant.|Regression, Logistic|Logistic regression based on the methodology of Zhang, Tsiatis and Davidian and Tsiatis, Davidian, Zhang and Lu, with adjustment for baseline HbA1c.||The probability of response was modeled using a logistic regression model with baseline HbA1c as the covariate. Treatment group estimates of response rate were then obtained by integrating each group's modeled probability of response over the observed distribution of baseline covariate (combined across groups).||23.9|5.9|0.0012
72506249|NCT00859898|144544384|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.3|STANDARD_ERROR_OF_MEAN|4.73||0.0165|TWO_SIDED|95.0|2.1|20.6||Dapagliflozin 10 mg plus metformin XR treatment group had to be superior to both monotherapy treatment groups to be considered significant.|Regression, Logistic|Logistic regression based on the methodology of Zhang, Tsiatis and Davidian and Tsiatis, Davidian, Zhang and Lu, with adjustment for baseline HbA1c.||The probability of response was modeled using a logistic regression model with baseline HbA1c as the covariate. Treatment group estimates of response rate were then obtained by integrating each group's modeled probability of response over the observed distribution of baseline covariate (combined across groups).||20.6|2.1|0.0165
72506250|NCT00859898|144544385|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.45|STANDARD_ERROR_OF_MEAN|0.1807||0.0133|TWO_SIDED|95.0|-0.81|-0.09||two-sided significance level at α=0.05. Dapagliflozin 10 mg plus metformin XR treatment group had to be superior to both monotherapy treatment groups to be considered significant.|ANCOVA|: treatment group as an effect and the baseline HbA1c value as a covariate.||A hierarchical closed testing procedure was implemented to control the familywise type I error rate related to this endpoint at the two-sided 0.05 level. Statistical testing was only performed if the dapagliflozin 10 mg plus metformin XR group was statistically significantly superior to both control groups for the primary efficacy endpoint. Tests were only performed for a given secondary endpoint if all previous sequential tests versus that treatment group were also significant.||-0.09|-0.81|0.0133
72506251|NCT00859898|144544385|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.53|STANDARD_ERROR_OF_MEAN|0.1817||0.0036|TWO_SIDED|95.0|-0.89|-0.18||two-sided significance level at α=0.05. Dapagliflozin 10 mg plus metformin XR treatment group had to be superior to both monotherapy treatment groups to be considered significant.|ANCOVA|treatment group as an effect and the baseline HbA1c value as a covariate.||A hierarchical closed testing procedure was implemented to control the familywise type I error rate related to this endpoint at the two-sided 0.05 level. Statistical testing was only performed if the dapagliflozin 10 mg plus metformin XR group was statistically significantly superior to both control groups for the primary efficacy endpoint. Tests were only performed for a given secondary endpoint if all previous sequential tests versus that treatment group were also significant.||-0.18|-0.89|0.0036
72506252|NCT00859898|144544386|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.97|STANDARD_ERROR_OF_MEAN|0.3401|<|0.0001|TWO_SIDED|95.0|-2.64|-1.3||two-sided significance level at α=0.05|ANCOVA|treatment group as an effect and the baseline value as a covariate.||A hierarchical closed testing procedure was implemented to control the familywise type I error rate related to this endpoint at the two-sided 0.05 level. Statistical testing was only performed if the dapagliflozin 10 mg plus metformin XR group was statistically significantly superior to both control groups for the primary efficacy endpoint. Tests were only performed for a given secondary endpoint if all previous sequential tests versus that treatment group were also significant.||-1.30|-2.64|<0.0001
72506253|NCT00859898|144544386|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.37|STANDARD_ERROR_OF_MEAN|0.3362|<|0.0001|TWO_SIDED|95.0|-2.03|-0.71||two-sided significance level at α=0.05|ANCOVA|treatment group as an effect and the baseline value as a covariate||Statistical tests were only performed for a given secondary endpoint if all previous sequential tests versus that treatment group were also significant.||-0.71|-2.03|<0.0001
72506254|NCT01327339|144544442|SUPERIORITY_OR_OTHER||percentage of participants|5.9|||||TWO_SIDED|95.0|4.3|7.8|||||The estimated value represents the percentage of participants with an adverse event.|||7.8|4.3|
72506255|NCT01847547|144544448|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.05||||||95.0|0.64|1.7|||Regression, Cox||Cox Proportional Hazard's regression following propensity score matching.|These current feasibility data are limited by a small sample size, short follow up, and few outcome events resulting in wide 95% confidence intervals. At this early stage, no comparative conclusions are possible. Future data with an increased number of patients are planned.||1.70|0.64|
72506256|NCT01847547|144544449|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.97||||||95.0|0.69|1.36|||Regression, Cox||Cox Proportional Hazard's regression following propensity score matching.|These current feasibility data are limited by a small sample size, short follow up, and few outcome events resulting in wide 95% confidence intervals. At this early stage, no comparative conclusions are possible. Future data with an increased number of patients are planned.||1.36|0.69|
72506257|NCT01847547|144544450|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.24||||||95.0|0.62|2.45|||Regression, Cox||Cox Proportional Hazard's regression following propensity score matching.|These current feasibility data are limited by a small sample size, short follow up, and few outcome events resulting in wide 95% confidence intervals. At this early stage, no comparative conclusions are possible. Future data with an increased number of patients are planned.||2.45|0.62|
72506258|NCT01847547|144544451|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.29||||||95.0|0.15|0.59|||Regression, Cox||Cox Proportional Hazard's regression following propensity score matching.|These current feasibility data are limited by a small sample size, short follow up, and few outcome events resulting in wide 95% confidence intervals. At this early stage, no comparative conclusions are possible. Future data with an increased number of patients are planned.||0.59|0.15|
72506259|NCT01847547|144544452|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.31||||||95.0|0.15|0.67|||Regression, Cox||Cox Proportional Hazard's regression following propensity score matching.|These current feasibility data are limited by a small sample size, short follow up, and few outcome events resulting in wide 95% confidence intervals. At this early stage, no comparative conclusions are possible.||0.67|0.15|
72506260|NCT01847547|144544453|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.27||||||95.0|0.09|0.84|||Regression, Cox||Cox Proportional Hazard's regression following propensity score matching.|These current feasibility data are limited by a small sample size, short follow up, and few outcome events resulting in wide 95% confidence intervals. At this early stage, no comparative conclusions are possible. Future data with an increased number of patients are planned.||0.84|0.09|
72506261|NCT01847547|144544454|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.25||||||95.0|0.78|2.01|||Regression, Cox||Cox Proportional Hazard's regression following propensity score matching.|These current feasibility data are limited by a small sample size, short follow up, and few outcome events resulting in wide 95% confidence intervals. At this early stage, no comparative conclusions are possible. Future data with an increased number of patients are planned.||2.01|0.78|
72506262|NCT01847547|144544456|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.74||||||95.0|0.48|1.14|||Regression, Cox||Cox Proportional Hazard's regression following propensity score matching.|These current feasibility data are limited by a small sample size, short follow up, and few outcome events resulting in wide 95% confidence intervals. At this early stage, no comparative conclusions are possible. Future data with an increased number of patients are planned.||1.14|0.48|
72565769|NCT02709486|144662698|SUPERIORITY||Least Square Mean Difference|-0.64|STANDARD_ERROR_OF_MEAN|0.15|<|0.0001|TWO_SIDED|95.0|-0.94|-0.35|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC stiffness subscales and baseline diary average pain as covariates, and study site as a random effect.||-0.35|-0.94|<.0001
72506263|NCT01847547|144544457|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.01||||||95.0|0.47|2.2|||Regression, Cox||Cox Proportional Hazard's regression following propensity score matching.|These current feasibility data are limited by a small sample size, short follow up, and few outcome events resulting in wide 95% confidence intervals. At this early stage, no comparative conclusions are possible. Future data with an increased number of patients are planned.||2.20|0.47|
72397570|NCT01103284|144301595|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.38||||0.07|TWO_SIDED|95.0|-0.02|0.79||Standard multiple imputation was used to predict the number and timing of hypoglycemic events after discontinuing the study for subjects who did not remain in the study until Month 25.|negative binomial regression|||The number of hypoglycemia events during the study was analyzed using a negative binomial regression model, with number of events as the dependent variable, and treatment, age, baseline daily insulin dose, and baseline C-peptide as covariates. The log of duration in the study for each patient was used as an offset variable in the model.||0.79|-0.02|0.07
72471944|NCT00422734|144467102|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for SEAR Overall Relationship|ANCOVA|Change from baseline ANCOVA model: treatment group, baseline value, pooled site. Baseline-by-treatment interaction included if interaction at p\<0.10.||||||<0.001
72471945|NCT02078492|144467126|NON_INFERIORITY_OR_EQUIVALENCE|We assumed a minimal clinically significant difference (MCSD) of 1.3 between the three ketorolac groups at the 30-minute pain assessment and a standard deviation of 3.0. A power analysis determined that a sample of 78 subjects per group provided at least 80% power to detect an MCSD of at least 1.3 at 30 minutes with α=0.05.||||||0.783|||||||ANOVA|2 degrees of freedom||The main hypothesis was that there would be equivalence of dose effect across the three groups at every time point, and the primary comparison consisted of the pain assessment at 30 minutes.||||.783
72565770|NCT02709486|144662698|SUPERIORITY||Least Square Mean Difference|-0.72|STANDARD_ERROR_OF_MEAN|0.16|<|0.0001|TWO_SIDED|95.0|-1.03|-0.41|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC stiffness subscales and baseline diary average pain as covariates, and study site as a random effect.||-0.41|-1.03|<.0001
72397571|NCT01346839|144301596|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Regression, Cox|||||||<0.05
72471946|NCT03321253|144467143|OTHER||||||<|0.01|||||||ANOVA|||||||<0.01
72471947|NCT00664534|144467157|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority margin is defined as 0.4%. If the upper 95%CI for difference in LSMeans is below 0.4% then MIX arm will be declared noninferior to GLAR arm|Least squares mean difference|-0.14|||||TWO_SIDED|95.0|-0.42|0.13|||||Least squares mean difference = (Premix insulin Lispro -Glargine)|||0.13|-0.42|
72471948|NCT00664534|144467159|SUPERIORITY_OR_OTHER||Least squares mean difference|0.05|||||TWO_SIDED|95.0|-0.18|0.29|||||Least squares mean difference = (Premix insulin Lispro - Glargine). 16 weeks|||0.29|-0.18|
72471949|NCT00664534|144467159|SUPERIORITY_OR_OTHER||Least squares mean difference|0.04|||||TWO_SIDED|95.0|-0.22|0.29|||||Least squares mean difference = (Premix insulin Lispro - Glargine). 32 weeks|||0.29|-0.22|
72471950|NCT00664534|144467159|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.08|||||TWO_SIDED|95.0|-0.33|0.18|||||Least squares mean difference = (Premix insulin Lispro - Glargine). 48 weeks|||0.18|-0.33|
72471951|NCT00664534|144467160|SUPERIORITY_OR_OTHER|||||||0.2127||95.0||||P-value is for Week 16 HbA1c \<=7.0%.|Chi-squared|||||||0.2127
72471952|NCT00664534|144467160|SUPERIORITY_OR_OTHER|||||||0.3281||95.0||||P-value is for Week 16 HbA1c \<=6.5%|Chi-squared|||||||0.3281
72471953|NCT00664534|144467160|SUPERIORITY_OR_OTHER|||||||0.2812||95.0||||P-value is for Week 32 HbA1c \<=7.0%|Chi-squared|||||||0.2812
72471954|NCT00664534|144467160|SUPERIORITY_OR_OTHER|||||||0.6963||95.0||||P-value is for Week 32 HbA1c \<=6.5%|Chi-squared|||||||0.6963
72471955|NCT00664534|144467160|SUPERIORITY_OR_OTHER|||||||0.0643||95.0||||P-value is for Week 48 HbA1c \<=7.0%|Chi-squared|||||||0.0643
72471956|NCT00664534|144467160|SUPERIORITY_OR_OTHER|||||||0.2524||95.0||||P-value is for Week 48 HbA1c \<=6.5%|Chi-squared|||||||0.2524
72471957|NCT00664534|144467162|SUPERIORITY_OR_OTHER|||||||0.6615||95.0||||P-value for Baseline|Wilcoxon (Mann-Whitney)|||||||0.6615
72471958|NCT00664534|144467162|SUPERIORITY_OR_OTHER|||||||0.9798||95.0||||P-value is for Week 16|Wilcoxon (Mann-Whitney)|||||||0.9798
72471959|NCT00664534|144467162|SUPERIORITY_OR_OTHER|||||||0.6169||95.0||||P-value for Week 32|Wilcoxon (Mann-Whitney)|||||||0.6169
72471960|NCT00664534|144467162|SUPERIORITY_OR_OTHER|||||||0.7834||95.0||||P-value for Week 48|Wilcoxon (Mann-Whitney)|||||||0.7834
72471961|NCT00664534|144467164|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.4|||TWO_SIDED|95.0|-0.89|0.7|||||Least Squares Mean Difference = Premix Insulin Lispro minus Glargine.|||0.70|-0.89|
72471962|NCT00664534|144467165|SUPERIORITY_OR_OTHER|||||||0.4935||95.0|||||Fisher Exact|||||||0.4935
72471963|NCT03041792|144467168|SUPERIORITY||Least Square Mean Difference|-235.75|STANDARD_ERROR_OF_MEAN|43.13||0|TWO_SIDED|95.0|-322.25|-149.25||The p-value was calculated and was rounded to 4th decimal presenting as 0.0000, which was smaller than the required threshold of \<0.05.|Mixed Models Analysis|||Visit 4||-149.25|-322.25|0.0000
72471964|NCT03041792|144467168|SUPERIORITY||Least Square Mean Difference|-243.63|STANDARD_ERROR_OF_MEAN|47.6||0|TWO_SIDED|95.0|-339.1|-148.15||The p-value was calculated and was rounded to 4th decimal presenting as 0.0000, which was smaller than the required threshold of \<0.05.|Mixed Models Analysis|||Visit 5||-148.15|-339.10|0.0000
72471965|NCT03041792|144467173|SUPERIORITY||Least Square Mean Difference|-859.58|STANDARD_ERROR_OF_MEAN|167.76||0|TWO_SIDED|95.0|-1196.1|-523.1||The p-value was calculated and was rounded to 4th decimal presenting as 0.0000, which was smaller than the required threshold of \<0.05.|Mixed Models Analysis|||Visit 4||-523.10|-1196.1|0.0000
72471966|NCT03041792|144467173|SUPERIORITY||Least Square Mean Difference|-928.56|STANDARD_ERROR_OF_MEAN|193.8||0|TWO_SIDED|95.0|-1317.3|-539.86||The p-value was calculated and was rounded to 4th decimal presenting as 0.0000, which was smaller than the required threshold of \<0.05.|Mixed Models Analysis|||Visit 5||-539.86|-1317.3|0.0000
72471967|NCT03041792|144467174|SUPERIORITY||Least Square Mean Difference|4.95|STANDARD_ERROR_OF_MEAN|2.16||0.0263|TWO_SIDED|95.0|0.61|9.29|||Mixed Models Analysis|||Visit 4||9.29|0.61|0.0263
72622963|NCT00500331|144776166|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.76|||<|0.001|TWO_SIDED|95.0|-1.05|-0.47||Pairwise comparison included for informational purposes and not controlled for multiplicity.|ANCOVA|Change=Baseline+Treatment||Placebo vs. Pioglitazone 30 mg||-0.47|-1.05|<0.001
72471968|NCT03041792|144467174|SUPERIORITY||Least Square Mean Difference|5.35|STANDARD_ERROR_OF_MEAN|2.06||0.0121|TWO_SIDED|95.0|1.22|9.48|||Mixed Models Analysis|||Visit 5||9.48|1.22|0.0121
72471969|NCT03041792|144467175|SUPERIORITY||Least Square Mean Difference|3.98|STANDARD_ERROR_OF_MEAN|2.91||0.1768|TWO_SIDED|95.0|-1.85|9.82|||Mixed Models Analysis|||Satiety (Visit 4)||9.82|-1.85|0.1768
72471970|NCT03041792|144467175|SUPERIORITY||Least Square Mean Difference|3.43|STANDARD_ERROR_OF_MEAN|2.13||0.1137|TWO_SIDED|95.0|-0.85|7.7|||Mixed Models Analysis|||Satiety (Visit 5)||7.70|-0.85|0.1137
72471971|NCT03041792|144467175|SUPERIORITY||Least Square Mean Difference|2.85|STANDARD_ERROR_OF_MEAN|2.12||0.1858|TWO_SIDED|95.0|-1.41|7.11|||Mixed Models Analysis|||Fullness (Visit 4)||7.11|-1.41|0.1858
72471972|NCT03041792|144467175|SUPERIORITY||Least Square Mean Difference|1.41|STANDARD_ERROR_OF_MEAN|2.22||0.5288|TWO_SIDED|95.0|-3.05|5.86|||Mixed Models Analysis|||Fullness (Visit 5)||5.86|-3.05|0.5288
72471973|NCT03041792|144467175|SUPERIORITY||Least Square Mean Difference|-8.46|STANDARD_ERROR_OF_MEAN|2.91||0.0054|TWO_SIDED|95.0|-14.3|-2.61|||Mixed Models Analysis|||Prospective food consumption (Visit 4)||-2.61|-14.30|0.0054
72471974|NCT03041792|144467175|SUPERIORITY||Least Square Mean Difference|-9.78|STANDARD_ERROR_OF_MEAN|3.75||0.0117|TWO_SIDED|95.0|-17.29|-2.27|||Mixed Models Analysis|||Prospective food consumption (Visit 5)||-2.27|-17.29|0.0117
72471975|NCT03041792|144467175|SUPERIORITY||Least Square Mean Difference|-6.58|STANDARD_ERROR_OF_MEAN|2.44||0.0093|TWO_SIDED|95.0|-11.48|-1.69|||Mixed Models Analysis|||Hunger (Visit 4)||-1.69|-11.48|0.0093
72471976|NCT03041792|144467175|SUPERIORITY||Least Square Mean Difference|-6.39|STANDARD_ERROR_OF_MEAN|2.86||0.0296|TWO_SIDED|95.0|-12.12|-0.66|||Mixed Models Analysis|||Hunger (Visit 5)||-0.66|-12.12|0.0296
72471977|NCT03041792|144467176|SUPERIORITY||Least Square Mean Difference|35.56|STANDARD_ERROR_OF_MEAN|52.46||0.5008|TWO_SIDED|95.0|-69.64|140.76|||Mixed Models Analysis|||AUC0-60min (Visit 4)||140.76|-69.64|0.5008
72471978|NCT03041792|144467176|SUPERIORITY||Least Square Mean Difference|106.15|STANDARD_ERROR_OF_MEAN|48.95||0.0348|TWO_SIDED|95.0|7.86|204.44|||Mixed Models Analysis|||AUC0-60min (Visit 5)||204.44|7.86|0.0348
72471979|NCT03041792|144467176|SUPERIORITY||Least Square Mean Difference|214.24|STANDARD_ERROR_OF_MEAN|129.48||0.104|TWO_SIDED|95.0|-45.59|474.07|||Mixed Models Analysis|||AUC0-300min (Visit 4)||474.07|-45.59|0.1040
72471980|NCT03041792|144467176|SUPERIORITY||Least Square Mean Difference|348.43|STANDARD_ERROR_OF_MEAN|138.29||0.0152|TWO_SIDED|95.0|70.2|626.66|||Mixed Models Analysis|||AUC0-300min (Visit 5)||626.66|70.20|0.0152
72471981|NCT00305344|144467293|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05||95.0|||||Fisher Exact|||Null hypothesis: there will be no difference between AUC C-peptide at baseline and 1 or 2 years post cord blood infusion||||>0.05
72471982|NCT02209181|144467314|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|16.38|STANDARD_ERROR_OF_MEAN|2.522|<|0.001|TWO_SIDED|95.0|11.42|21.35||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||21.35|11.42|<0.001
72471983|NCT02209181|144467314|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|4.58|STANDARD_ERROR_OF_MEAN|2.503||0.068|TWO_SIDED|95.0|-0.35|9.51||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||9.51|-0.35|0.068
72471984|NCT02209181|144467314|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|16.2|STANDARD_ERROR_OF_MEAN|2.531|<|0.001|TWO_SIDED|95.0|11.21|21.18||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||21.18|11.21|<0.001
72471985|NCT02209181|144467314|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-11.81|STANDARD_ERROR_OF_MEAN|2.503|<|0.001|TWO_SIDED|95.0|-16.73|-6.88||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||-6.88|-16.73|<0.001
72471986|NCT02209181|144467314|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|2.531||0.941|TWO_SIDED|95.0|-5.17|4.8||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||4.80|-5.17|0.941
72506264|NCT01847547|144544458|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.65||||||95.0|0.21|1.98|||Regression, Cox||Cox Proportional Hazard's regression following propensity score matching.|These current feasibility data are limited by a small sample size, short follow up, and very few outcome events resulting in wide 95% confidence intervals. At this early stage, no comparative conclusions are possible. Future data with an increased number of patients are planned.||1.98|0.21|
72506265|NCT01847547|144544459|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.74||||||95.0|0.5|1.08|||Regression, Cox||Cox Proportional Hazard's regression following propensity score matching.|These current feasibility data are limited by a small sample size, short follow up, and few outcome events resulting in wide 95% confidence intervals. At this early stage, no comparative conclusions are possible. Future data with an increased number of patients are planned.||1.08|0.50|
72622964|NCT02014467|144776222|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.42|||<|0.0001|TWO_SIDED|95.0|3.67|5.18|||ANCOVA|||||5.18|3.67|<0.0001
72471987|NCT02209181|144467315|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.12|STANDARD_ERROR_OF_MEAN|0.15||0.448|TWO_SIDED|95.0|-0.19|0.42||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.42|-0.19|0.448
72471988|NCT02209181|144467315|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.15||0.618|TWO_SIDED|95.0|-0.38|0.22||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.22|-0.38|0.618
72471989|NCT02209181|144467315|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.08|STANDARD_ERROR_OF_MEAN|0.15||0.621|TWO_SIDED|95.0|-0.23|0.38||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.38|-0.23|0.621
72397572|NCT02723084|144301671|NON_INFERIORITY|The percentage of participants achieving SVR12 was calculated for each arm and a 2- sided 95% confidence interval (CI) for the difference in SVR12 rates (Arm A minus Arm B) was calculated using the normal approximation to the binomial distribution to assess non-inferiority in SVR12 rates of arm A to arm B. If the lower bound of the CI for the difference was above the noninferiority margin of -10%, then arm A was considered non-inferior to arm B.|Risk Difference (RD)|4.3|||||TWO_SIDED|95.0|-3.5|12.1|||||95% CI was calculated using the normal approximation to the binomial distribution.|Difference in SVR12 rates (Arm A - Arm B)||12.1|-3.5|
72397573|NCT02801942|144301689|OTHER||Mean Difference (Final Values)|2.31|STANDARD_ERROR_OF_MEAN|3.307|||TWO_SIDED|95.0|-4.59|9.21|||||The mean difference in circulating B lymphocytes (Healthy participants versus NOT1D participants) in blood has been presented.|||9.21|-4.59|
72397574|NCT02801942|144301689|OTHER||Mean Difference (Final Values)|3.54|STANDARD_ERROR_OF_MEAN|2.398|||TWO_SIDED|95.0|-1.46|8.54|||||The mean difference in Classical B Lymphocytes (Healthy participants versus NOT1D participants) in blood has been presented.|||8.54|-1.46|
72471990|NCT02209181|144467315|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.15||0.207|TWO_SIDED|95.0|-0.49|0.11||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.11|-0.49|0.207
72471991|NCT02209181|144467315|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.15||0.794|TWO_SIDED|95.0|-0.34|0.26||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.26|-0.34|0.794
72471992|NCT02209181|144467316|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|1.34|STANDARD_ERROR_OF_MEAN|0.26|<|0.001|TWO_SIDED|95.0|0.82|1.86||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.86|0.82|<0.001
72471993|NCT02209181|144467316|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.21|STANDARD_ERROR_OF_MEAN|0.26||0.42|TWO_SIDED|95.0|-0.3|0.72||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.72|-0.30|0.420
72471994|NCT02209181|144467316|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.46|STANDARD_ERROR_OF_MEAN|0.26||0.083|TWO_SIDED|95.0|-0.06|0.97||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.97|-0.06|0.083
72471995|NCT02209181|144467316|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-1.13|STANDARD_ERROR_OF_MEAN|0.26|<|0.001|TWO_SIDED|95.0|-1.64|-0.62||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||-0.62|-1.64|<0.001
72471996|NCT02209181|144467316|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.88|STANDARD_ERROR_OF_MEAN|0.26|<|0.001|TWO_SIDED|95.0|-1.4|-0.37||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||-0.37|-1.40|<0.001
72565771|NCT02709486|144662698|SUPERIORITY||Least Square Mean Difference|-0.84|STANDARD_ERROR_OF_MEAN|0.16|<|0.0001|TWO_SIDED|95.0|-1.15|-0.53|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC stiffness subscales and baseline diary average pain as covariates, and study site as a random effect.||-0.53|-1.15|<.0001
72565772|NCT02709486|144662698|SUPERIORITY||Least Square Mean Difference|-0.58|STANDARD_ERROR_OF_MEAN|0.17||0.0004|TWO_SIDED|95.0|-0.91|-0.26|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC stiffness subscales and baseline diary average pain as covariates, and study site as a random effect.||-0.26|-0.91|0.0004
72397575|NCT02801942|144301689|OTHER||Mean Difference (Final Values)|-3.01|STANDARD_ERROR_OF_MEAN|1.854|||TWO_SIDED|95.0|-6.87|0.86|||||The mean difference in Double Negative B Lymphocytes (Healthy participants versus NOT1D participants) in blood has been presented.|||0.86|-6.87|
72397576|NCT02801942|144301689|OTHER||Mean Difference (Final Values)|-2.51|STANDARD_ERROR_OF_MEAN|4.482||||95.0|-11.86|6.84|||||The mean difference in Naive B Lymphocytes (Healthy participants versus NOT1D participants) in blood has been presented.|||6.84|-11.86|
72622965|NCT02014467|144776222|SUPERIORITY_OR_OTHER|||||||0.7495||95.0||||Treatment By Region Interaction: Based on ANCOVA, Percent change from Baseline = Baseline + treatment + region + treatment by region|ANCOVA|||||||0.7495
72397577|NCT02801942|144301690|OTHER||Mean Difference (Final Values)|3.38|STANDARD_ERROR_OF_MEAN|2.658|||TWO_SIDED|95.0|-2.22|8.98|||||The mean difference in Circulating B Lymphocytes (Healthy participants versus NOT1D participants) in iLN has been presented.|||8.98|-2.22|
72397578|NCT02801942|144301690|OTHER||Mean Difference (Final Values)|8.59|STANDARD_ERROR_OF_MEAN|5.833|||TWO_SIDED|95.0|-3.72|20.91|||||The mean difference in Classical B Lymphocytes (Healthy participants versus NOT1D participants) in iLN has been presented.|||20.91|-3.72|
72397579|NCT02801942|144301690|OTHER||Mean Difference (Final Values)|-1.58|STANDARD_ERROR_OF_MEAN|2.347|||TWO_SIDED|95.0|-6.53|3.38|||||The mean difference in Double Negative B Lymphocytes (Healthy participants versus NOT1D participants) in iLN has been presented.|||3.38|-6.53|
72397580|NCT02801942|144301690|OTHER||Mean Difference (Final Values)|-8.31|STANDARD_ERROR_OF_MEAN|5.221|||TWO_SIDED|95.0|-19.32|2.71|||||The mean difference in Naive B Lymphocytes (Healthy participants versus NOT1D participants) in iLN has been presented.|||2.71|-19.32|
72471997|NCT02209181|144467317|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|2.93|STANDARD_ERROR_OF_MEAN|0.33|<|0.001|TWO_SIDED|95.0|2.28|3.59||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||3.59|2.28|<0.001
72397581|NCT02801942|144301691|OTHER||Mean Difference (Final Values)|0.92|STANDARD_ERROR_OF_MEAN|0.873|||TWO_SIDED|95.0|-0.9|2.75|||||The mean difference in B-cells (Healthy participants versus NOT1D participants) in blood has been presented.|||2.75|-0.90|
72622966|NCT02014467|144776223|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.21|||<|0.0001|TWO_SIDED|95.0|2.45|3.96|||ANCOVA|||||3.96|2.45|<0.0001
72397582|NCT02801942|144301691|OTHER||Mean Difference (Final Values)|0.06|STANDARD_ERROR_OF_MEAN|0.063|||TWO_SIDED|95.0|-0.07|0.19|||||The mean difference in CD56bright NK cells (Healthy participants versus NOT1D participants) in blood has been presented.|||0.19|-0.07|
72471998|NCT02209181|144467317|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.63|STANDARD_ERROR_OF_MEAN|0.33||0.058|TWO_SIDED|95.0|-0.02|1.29||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.29|-0.02|0.058
72471999|NCT02209181|144467317|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|1.23|STANDARD_ERROR_OF_MEAN|0.34|<|0.001|TWO_SIDED|95.0|0.57|1.89||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.89|0.57|<0.001
72472000|NCT02209181|144467317|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-2.3|STANDARD_ERROR_OF_MEAN|0.33|<|0.001|TWO_SIDED|95.0|-2.96|-1.65||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||-1.65|-2.96|<0.001
72472001|NCT02209181|144467317|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-1.71|STANDARD_ERROR_OF_MEAN|0.34|<|0.001|TWO_SIDED|95.0|-2.37|-1.04||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||-1.04|-2.37|<0.001
72472002|NCT02209181|144467318|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|3.73|STANDARD_ERROR_OF_MEAN|0.37|<|0.001|TWO_SIDED|95.0|3.01|4.46||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||4.46|3.01|<0.001
72472003|NCT02209181|144467318|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.78|STANDARD_ERROR_OF_MEAN|0.36||0.035|TWO_SIDED|95.0|0.06|1.49||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.49|0.06|0.035
72472004|NCT02209181|144467318|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|1.94|STANDARD_ERROR_OF_MEAN|0.37|<|0.001|TWO_SIDED|95.0|1.21|2.67||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||2.67|1.21|<0.001
72472005|NCT02209181|144467318|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-2.96|STANDARD_ERROR_OF_MEAN|0.36|<|0.001|TWO_SIDED|95.0|-3.68|-2.24||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||-2.24|-3.68|<0.001
72472006|NCT02209181|144467318|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-1.79|STANDARD_ERROR_OF_MEAN|0.37|<|0.001|TWO_SIDED|95.0|-2.52|-1.07||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||-1.07|-2.52|<0.001
72472007|NCT02209181|144467319|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|3.99|STANDARD_ERROR_OF_MEAN|0.39|<|0.001|TWO_SIDED|95.0|3.21|4.77||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||4.77|3.21|<0.001
72622967|NCT02014467|144776223|SUPERIORITY_OR_OTHER|||||||0.9029||95.0||||Treatment By Region Interaction: Based on ANCOVA, Percent change from Baseline = Baseline + treatment + region + treatment by region|ANCOVA|||||||0.9029
72472008|NCT02209181|144467319|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.86|STANDARD_ERROR_OF_MEAN|0.39||0.028|TWO_SIDED|95.0|0.09|1.64||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.64|0.09|0.028
72472009|NCT02209181|144467319|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|2.48|STANDARD_ERROR_OF_MEAN|0.4|<|0.001|TWO_SIDED|95.0|1.7|3.26||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||3.26|1.70|<0.001
72472010|NCT02209181|144467319|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-3.12|STANDARD_ERROR_OF_MEAN|0.39|<|0.001|TWO_SIDED|95.0|-3.9|-2.35||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||-2.35|-3.90|<0.001
72472011|NCT02209181|144467319|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-1.51|STANDARD_ERROR_OF_MEAN|0.4|<|0.001|TWO_SIDED|95.0|-2.29|-0.73||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||-0.73|-2.29|<0.001
72472012|NCT02209181|144467320|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|3.78|STANDARD_ERROR_OF_MEAN|0.44|<|0.001|TWO_SIDED|95.0|2.92|4.65||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||4.65|2.92|<0.001
72622968|NCT02014467|144776224|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.26|||<|0.0001|TWO_SIDED|95.0|1.72|2.8|||ANCOVA|||||2.80|1.72|<0.0001
72622969|NCT02014467|144776224|SUPERIORITY_OR_OTHER|||||||0.107||95.0||||Treatment By Region Interaction: Based on ANCOVA, Percent change from Baseline = Baseline + treatment + region + treatment by region|ANCOVA|||||||0.1070
72506266|NCT01847547|144544460|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.4||||||95.0|0.21|0.76|||Regression, Cox||Cox Proportional Hazard's regression following propensity score matching.|These current feasibility data are limited by a small sample size, short follow up, and few outcome events resulting in wide 95% confidence intervals. At this early stage, no comparative conclusions are possible. Future data with an increased number of patients are planned.||0.76|0.21|
72506267|NCT01847547|144544461|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.95||||||95.0|0.58|1.55|||Regression, Cox||Cox Proportional Hazard's regression following propensity score matching.|These current feasibility data are limited by a small sample size, short follow up, and few outcome events resulting in wide 95% confidence intervals. At this early stage, no comparative conclusions are possible. Future data with an increased number of patients are planned.||1.55|0.58|
72506268|NCT01847547|144544462|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.36||||||95.0|0.32|5.72|||Regression, Cox||Cox Proportional Hazard's regression following propensity score matching.|These current feasibility data are limited by a small sample size, short follow up, and very few outcome events resulting in wide 95% confidence intervals. At this early stage, no comparative conclusions are possible. Future data with an increased number of patients are planned.||5.72|0.32|
72506269|NCT01847547|144544463|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.6||||||95.0|0.83|3.08|||Regression, Cox||Cox Proportional Hazard's regression following propensity score matching.|These current feasibility data are limited by a small sample size, short follow up, and few outcome events resulting in wide 95% confidence intervals. At this early stage, no comparative conclusions are possible. Future data with an increased number of patients are planned.||3.08|0.83|
72506270|NCT01847547|144544464|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.45||||||95.0|0.57|3.7|||Regression, Cox||Cox Proportional Hazard's regression following propensity score matching.|These current feasibility data are limited by a small sample size, short follow up, and few outcome events resulting in wide 95% confidence intervals. At this early stage, no comparative conclusions are possible. Future data with an increased number of patients are planned.||3.70|0.57|
72506271|NCT01847547|144544465|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.95||||||95.0|0.67|1.35|||Regression, Cox||Cox Proportional Hazard's regression following propensity score matching.|These current feasibility data are limited by a small sample size, short follow up, and few outcome events resulting in wide 95% confidence intervals. At this early stage, no comparative conclusions are possible.||1.35|0.67|
72506272|NCT01847547|144544466|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.26||||||95.0|0.79|2.01|||Regression, Cox||Cox Proportional Hazard's regression following propensity score matching.|These current feasibility data are limited by a small sample size, short follow up, and few outcome events resulting in wide 95% confidence intervals. At this early stage, no comparative conclusions are possible. Future data with an increased number of patients are planned.||2.01|0.79|
72506273|NCT00700752|144544467|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.1636|STANDARD_ERROR_OF_MEAN|0.1887|||TWO_SIDED|95.0|0.789|1.1636|||Mixed Models Analysis||The mean difference is calculated as senofilcon A minus balafilcon A.|Alternative hypothesis is senofilcon A is superior to balafilcon A for comfort.||1.1636|0.7890|
72506274|NCT00510692|144544477|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.06||||0.005|TWO_SIDED|95.0|-1.78|-0.35|||ANCOVA|||||-0.35|-1.78|0.005
72506275|NCT01845077|144544482|NON_INFERIORITY_OR_EQUIVALENCE|Standard acceptance criterion for bioequivalence: 90% confidence interval is completely within the bounds of 80-125%. No formal hypothesis test was conducted as study is exploratory.|Ratio of geometric means|99.3|||||TWO_SIDED|90.0|95.3|103.5|||ANOVA|ANOVA on the logarithmic scale, adjusted for subjects within sequences as random effect and sequence, period and treatment as fixed effects.||||103.5|95.3|
72506276|NCT01845077|144544482|NON_INFERIORITY_OR_EQUIVALENCE|Standard acceptance criterion for bioequivalence: 90% confidence interval is completely within the bounds of 80-125%. No formal hypothesis test was conducted as study is exploratory.|Ratio of geometric means|101.5|||||TWO_SIDED|90.0|98.4|104.7|||ANOVA|ANOVA on the logarithmic scale, adjusted for subjects within sequences as random effect and sequence, period and treatment as fixed effects.||One patient was excluded from this analysis due to the lack of the 72h sample for the L+M1000 fed treatment.||104.7|98.4|
72506277|NCT01845077|144544482|NON_INFERIORITY_OR_EQUIVALENCE|Standard acceptance criterion for bioequivalence: 90% confidence interval is completely within the bounds of 80-125%. No formal hypothesis test was conducted as study is exploratory.|Ratio of geometric means|100.9|||||TWO_SIDED|90.0|98.2|103.7|||ANOVA|ANOVA on the logarithmic scale, adjusted for subjects within sequences as random effect and sequence, period and treatment as fixed effects.||||103.7|98.2|
72506278|NCT01845077|144544483|NON_INFERIORITY_OR_EQUIVALENCE|Standard acceptance criterion for bioequivalence: 90% confidence interval is completely within the bounds of 80-125%. No formal hypothesis test was conducted as study is exploratory.|Ratio of geometric means|94.9|||||TWO_SIDED|90.0|86.8|103.6|||ANOVA|ANOVA on the logarithmic scale, adjusted for subjects within sequences as random effect and sequence, period and treatment as fixed effects.||||103.6|86.8|
72506279|NCT01845077|144544483|NON_INFERIORITY_OR_EQUIVALENCE|Standard acceptance criterion for bioequivalence: 90% confidence interval is completely within the bounds of 80-125%. No formal hypothesis test was conducted as study is exploratory.|Ratio of geometric means|96.8|||||TWO_SIDED|90.0|90.2|103.8|||ANOVA|ANOVA on the logarithmic scale, adjusted for subjects within sequences as random effect and sequence, period and treatment as fixed effects.||||103.8|90.2|
72506280|NCT01845077|144544483|NON_INFERIORITY_OR_EQUIVALENCE|Standard acceptance criterion for bioequivalence: 90% confidence interval is completely within the bounds of 80-125%. No formal hypothesis test was conducted as study is exploratory.|Ratio of geometric means|108.6||||||90.0|99.5|118.5|||ANOVA|ANOVA on the logarithmic scale, adjusted for subjects within sequences as random effect and sequence, period and treatment as fixed effects.||||118.5|99.5|
72506281|NCT01845077|144544484|NON_INFERIORITY_OR_EQUIVALENCE|Standard acceptance criterion for bioequivalence: 90% confidence interval is completely within the bounds of 80-125%. No formal hypothesis test was conducted as study is exploratory.|Ratio of geometric means|103.7|||||TWO_SIDED|90.0|97.1|110.8|||ANOVA|ANOVA on the logarithmic scale, adjusted for subjects within sequences as random effect and sequence, period and treatment as fixed effects.||||110.8|97.1|
72506282|NCT01845077|144544484|NON_INFERIORITY_OR_EQUIVALENCE|Standard acceptance criterion for bioequivalence: 90% confidence interval is completely within the bounds of 80-125%. No formal hypothesis test was conducted as study is exploratory.|Ratio of geometric means|105.3|||||TWO_SIDED|90.0|99.9|111.0|||ANOVA|ANOVA on the logarithmic scale, adjusted for subjects within sequences as random effect and sequence, period and treatment as fixed effects.||||111.0|99.9|
72397583|NCT02801942|144301691|OTHER||Mean Difference (Final Values)|-0.29|STANDARD_ERROR_OF_MEAN|1.5|||TWO_SIDED|95.0|-3.41|2.84|||||The mean difference in CD56lo CD16+ (Healthy participants versus NOT1D participants) in blood has been presented.|||2.84|-3.41|
72397584|NCT02801942|144301691|OTHER||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.054|||TWO_SIDED|95.0|-0.1|0.13|||||The mean difference in CD56lo CD16- (Healthy participants versus NOT1D participants) in blood has been presented.|||0.13|-0.10|
72397585|NCT02801942|144301691|OTHER||Mean Difference (Final Values)|0.06|STANDARD_ERROR_OF_MEAN|0.118|||TWO_SIDED|95.0|-0.19|0.31|||||The mean difference in Dendritic cells (Healthy participants versus NOT1D participants) in blood has been presented.|||0.31|-0.19|
72397586|NCT02801942|144301691|OTHER||Mean Difference (Final Values)|-0.14|STANDARD_ERROR_OF_MEAN|1.482|||TWO_SIDED|95.0|-3.23|2.96|||||The mean difference in NK cells (Healthy participants versus NOT1D participants) in blood has been presented.|||2.96|-3.23|
72397587|NCT02801942|144301692|OTHER||Mean Difference (Final Values)|1.54|STANDARD_ERROR_OF_MEAN|2.231|||TWO_SIDED|95.0|-3.14|6.23|||||The mean difference in B-cells in (Healthy participants versus NOT1D participants) iLN has been presented.|||6.23|-3.14|
72397588|NCT02801942|144301692|OTHER||Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|-0.25|0.34|||||The mean difference in CD56bright sNK cells (Healthy participants versus NOT1D participants) in iLN has been presented.|||0.34|-0.25|
72397589|NCT02801942|144301692|OTHER||Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.253|||TWO_SIDED|95.0|-0.54|0.52|||||The mean difference in CD56lo CD16+ (Healthy participants versus NOT1D participants) in iLN has been presented.|||0.52|-0.54|
72397590|NCT02801942|144301692|OTHER||Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.059|||TWO_SIDED|95.0|-0.15|0.1|||||The mean difference in CD56lo CD16- (Healthy participants versus NOT1D participants) in iLN has been presented.|||0.10|-0.15|
72397591|NCT02801942|144301692|OTHER||Mean Difference (Final Values)|-0.07|STANDARD_ERROR_OF_MEAN|0.128|||TWO_SIDED|95.0|-0.21|0.34|||||The mean difference in Dendritic cells (Healthy participants versus NOT1D participants) in iLN has been presented.|||0.34|-0.21|
72397592|NCT02801942|144301692|OTHER||Mean Difference (Final Values)|-0.07|STANDARD_ERROR_OF_MEAN|0.487|||TWO_SIDED|95.0|-1.1|0.96|||||The mean difference in NK cells (Healthy participants versus NOT1D participants) in iLN has been presented.|||0.96|-1.10|
72472013|NCT02209181|144467320|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|1.02|STANDARD_ERROR_OF_MEAN|0.44||0.021|TWO_SIDED|95.0|0.16|1.88||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.88|0.16|0.021
72472014|NCT02209181|144467320|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|3.06|STANDARD_ERROR_OF_MEAN|0.44|<|0.001|TWO_SIDED|95.0|2.19|3.93||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||3.93|2.19|<0.001
72472015|NCT02209181|144467320|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-2.77|STANDARD_ERROR_OF_MEAN|0.44|<|0.001|TWO_SIDED|95.0|-3.63|-1.91||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||-1.91|-3.63|<0.001
72472016|NCT02209181|144467320|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.72|STANDARD_ERROR_OF_MEAN|0.44||0.104|TWO_SIDED|95.0|-1.59|0.15||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.15|-1.59|0.104
72397593|NCT02801942|144301693|OTHER||Mean Difference (Final Values)|1.03|STANDARD_ERROR_OF_MEAN|1.326|||TWO_SIDED|95.0|-1.73|3.8|||||The mean difference in CD56bright NK cells (Healthy participants versus NOT1D participants) in blood has been presented.|||3.80|-1.73|
72397594|NCT02801942|144301693|OTHER||Mean Difference (Final Values)|-2.69|STANDARD_ERROR_OF_MEAN|2.324|||TWO_SIDED|95.0|-7.54|2.16|||||The mean difference in CD56lo CD16+ (Healthy participants versus NOT1D participants) in blood has been presented.|||2.16|-7.54|
72397595|NCT02801942|144301693|OTHER||Mean Difference (Final Values)|0.42|STANDARD_ERROR_OF_MEAN|0.738|||TWO_SIDED|95.0|-1.12|1.95|||||The mean difference in CD56lo CD16- (Healthy participants versus NOT1D participants) in blood has been presented.|||1.95|-1.12|
72397596|NCT02801942|144301694|OTHER||Mean Difference (Final Values)|6.84|STANDARD_ERROR_OF_MEAN|5.564|||TWO_SIDED|95.0|-4.92|18.6|||||The mean difference in CD56bright NK cells (Healthy participants versus NOT1D participants) in iLN has been presented.|||18.60|-4.92|
72397597|NCT02801942|144301694|OTHER||Mean Difference (Final Values)|-7.89|STANDARD_ERROR_OF_MEAN|7.918|||TWO_SIDED|95.0|-24.77|9.0|||||The mean difference in CD56lo CD16+ (Healthy participants versus NOT1D participants) in iLN has been presented.|||9.00|-24.77|
72397598|NCT02801942|144301694|OTHER||Mean Difference (Final Values)|-1.46|STANDARD_ERROR_OF_MEAN|2.379|||TWO_SIDED|95.0|-6.66|3.73|||||The mean difference in CD56lo CD16- (Healthy participants versus NOT1D participants) in iLN has been presented.|||3.73|-6.66|
72397599|NCT02801942|144301695|OTHER||Mean Difference (Final Values)|1.33|STANDARD_ERROR_OF_MEAN|4.558|||TWO_SIDED|95.0|-8.17|10.84|||||The mean difference in myeloid dendritic cells (Healthy participants versus NOT1D participants) in blood has been presented.|||10.84|-8.17|
72397600|NCT02801942|144301695|OTHER||Mean Difference (Final Values)|-1.85|STANDARD_ERROR_OF_MEAN|4.658|||TWO_SIDED|95.0|-11.57|7.86|||||The mean difference in plasmacytoid dendritic cells (Healthy participants versus NOT1D participants) in blood has been presented.|||7.86|-11.57|
72622970|NCT02014467|144776225|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.59|||<|0.0001|TWO_SIDED|95.0|0.98|2.2|||ANCOVA|||||2.20|0.98|<0.0001
72472017|NCT02209181|144467321|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|3.13|STANDARD_ERROR_OF_MEAN|0.48|<|0.001|TWO_SIDED|95.0|2.18|4.07||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||4.07|2.18|<0.001
72472018|NCT02209181|144467321|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.98|STANDARD_ERROR_OF_MEAN|0.48||0.041|TWO_SIDED|95.0|0.04|1.92||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.92|0.04|0.041
72506283|NCT01845077|144544484|NON_INFERIORITY_OR_EQUIVALENCE|Standard acceptance criterion for bioequivalence: 90% confidence interval is completely within the bounds of 80-125%. No formal hypothesis test was conducted as study is exploratory.|Ratio of geometric means|96.9|||||TWO_SIDED|90.0|90.2|104.1|||ANOVA|ANOVA on the logarithmic scale, adjusted for subjects within sequences as random effect and sequence, period and treatment as fixed effects.||||104.1|90.2|
72506284|NCT01845077|144544485|NON_INFERIORITY_OR_EQUIVALENCE|Standard acceptance criterion for bioequivalence: 90% confidence interval is completely within the bounds of 80-125%. No formal hypothesis test was conducted as study is exploratory.|Ratio of geometric means|96.9|||||TWO_SIDED|90.0|86.8|108.2|||ANOVA|ANOVA on the logarithmic scale, adjusted for subjects within sequences as random effect and sequence, period and treatment as fixed effects.||||108.2|86.8|
72506285|NCT01845077|144544485|NON_INFERIORITY_OR_EQUIVALENCE|Standard acceptance criterion for bioequivalence: 90% confidence interval is completely within the bounds of 80-125%. No formal hypothesis test was conducted as study is exploratory.|Ratio of geometric means|99.7|||||TWO_SIDED|90.0|96.1|103.5|||ANOVA|ANOVA on the logarithmic scale, adjusted for subjects within sequences as random effect and sequence, period and treatment as fixed effects.||||103.5|96.1|
72506286|NCT01845077|144544485|NON_INFERIORITY_OR_EQUIVALENCE|Standard acceptance criterion for bioequivalence: 90% confidence interval is completely within the bounds of 80-125%. No formal hypothesis test was conducted as study is exploratory.|Ratio of geometric means|95.9|||||TWO_SIDED|90.0|86.7|106.0|||ANOVA|ANOVA on the logarithmic scale, adjusted for subjects within sequences as random effect and sequence, period and treatment as fixed effects.||||106.0|86.7|
72506287|NCT01845077|144544486|NON_INFERIORITY_OR_EQUIVALENCE|Standard acceptance criterion for bioequivalence: 90% confidence interval is completely within the bounds of 80-125%. No formal hypothesis test was conducted as study is exploratory.|Ratio of geometric means|96.8|||||TWO_SIDED|90.0|86.6|108.2|||ANOVA|ANOVA on the logarithmic scale, adjusted for subjects within sequences as random effect and sequence, period and treatment as fixed effects.||||108.2|86.6|
72506288|NCT01845077|144544486|NON_INFERIORITY_OR_EQUIVALENCE|Standard acceptance criterion for bioequivalence: 90% confidence interval is completely within the bounds of 80-125%. No formal hypothesis test was conducted as study is exploratory.|Ratio of geometric means|99.4|||||TWO_SIDED|90.0|95.6|103.4|||ANOVA|ANOVA on the logarithmic scale, adjusted for subjects within sequences as random effect and sequence, period and treatment as fixed effects.||||103.4|95.6|
72506289|NCT01845077|144544486|NON_INFERIORITY_OR_EQUIVALENCE|Standard acceptance criterion for bioequivalence: 90% confidence interval is completely within the bounds of 80-125%. No formal hypothesis test was conducted as study is exploratory.|Ratio of geometric means|99.3|||||TWO_SIDED|90.0|90.1|109.5|||ANOVA|ANOVA on the logarithmic scale, adjusted for subjects within sequences as random effect and sequence, period and treatment as fixed effects.||||109.5|90.1|
72506290|NCT01845077|144544487|NON_INFERIORITY_OR_EQUIVALENCE|Standard acceptance criterion for bioequivalence: 90% confidence interval is completely within the bounds of 80-125%. No formal hypothesis test was conducted as study is exploratory.|Ratio of geometric means|96.5|||||TWO_SIDED|90.0|84.8|109.8|||ANOVA|ANOVA on the logarithmic scale, adjusted for subjects within sequences as random effect and sequence, period and treatment as fixed effects.||||109.8|84.8|
72506291|NCT01845077|144544487|NON_INFERIORITY_OR_EQUIVALENCE|Standard acceptance criterion for bioequivalence: 90% confidence interval is completely within the bounds of 80-125%. No formal hypothesis test was conducted as study is exploratory.|Ratio of geometric means|103.2|||||TWO_SIDED|90.0|98.9|107.7|||ANOVA|ANOVA on the logarithmic scale, adjusted for subjects within sequences as random effect and sequence, period and treatment as fixed effects.||||107.7|98.9|
72506292|NCT01845077|144544487|NON_INFERIORITY_OR_EQUIVALENCE|Standard acceptance criterion for bioequivalence: 90% confidence interval is completely within the bounds of 80-125%. No formal hypothesis test was conducted as study is exploratory.|Ratio of geometric means|107.7|||||TWO_SIDED|90.0|92.5|125.4|||ANOVA|ANOVA on the logarithmic scale, adjusted for subjects within sequences as random effect and sequence, period and treatment as fixed effects.||||125.4|92.5|
72506293|NCT02746679|144544504|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA|The comparison of the change from baseline to 8 weeks later between MBSR Group and wait-list control group.||||||<0.001
72506294|NCT02746679|144544505|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||||||>0.05
72506295|NCT02746679|144544506|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||||||>0.05
72506296|NCT02746679|144544507|SUPERIORITY_OR_OTHER|||||||0.024|||||||Chi-squared|||||||0.024
72506297|NCT02746679|144544508|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA|The comparison of the change from baseline to 8 weeks later between MBSR Group and wait-list control group.||||||<0.001
72506298|NCT02746679|144544509|SUPERIORITY_OR_OTHER|||||||0.001|||||||ANOVA|The comparison of the change from baseline to 8 weeks later between MBSR Group and wait-list control group.||||||0.001
72506299|NCT02746679|144544510|SUPERIORITY_OR_OTHER|||||||0.003|||||||ANOVA|The comparison of the change from baseline to 8 weeks later between MBSR Group and wait-list control group.||||||0.003
72506300|NCT02746679|144544511|SUPERIORITY_OR_OTHER|||||||0.024|||||||ANOVA|The comparison of the change from baseline to 8 weeks later between MBSR Group and wait-list control group.||||||0.024
72506301|NCT02746679|144544512|SUPERIORITY_OR_OTHER|||||||0.004|||||||ANOVA|The comparison of the change from baseline to 8 weeks later between MBSR Group and wait-list control group.||||||0.004
72506302|NCT02746679|144544513|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA|The comparison of the change from baseline to 8 weeks later between MBSR Group and wait-list control group.||||||<0.001
72506303|NCT02746679|144544514|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA|The comparison of the change from baseline to 8 weeks later between MBSR Group and wait-list control group.||||||<0.001
72565773|NCT02709486|144662698|SUPERIORITY||Least Square Mean Difference|-0.99|STANDARD_ERROR_OF_MEAN|0.16|<|0.0001|TWO_SIDED|95.0|-1.31|-0.67|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC stiffness subscales and baseline diary average pain as covariates, and study site as a random effect.||-0.67|-1.31|<.0001
72622971|NCT02014467|144776225|SUPERIORITY_OR_OTHER|||||||0.4369||95.0||||Treatment By Region Interaction: Based on ANCOVA, Percent change from Baseline = Baseline + treatment + region + treatment by region|ANCOVA|||||||0.4369
72622972|NCT02014467|144776226|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.36|||<|0.0001||95.0|2.39|4.32|||ANCOVA|||||4.32|2.39|<0.0001
72506304|NCT02746679|144544515|SUPERIORITY_OR_OTHER|||||||0.277|||||||ANOVA|The comparison of the change from baseline to 8 weeks later between MBSR Group and wait-list control group.||||||0.277
72506305|NCT02746679|144544516|SUPERIORITY_OR_OTHER|||||||0.001|||||||ANOVA|The comparison of the change from baseline to 8 weeks later between MBSR Group and wait-list control group.||||||0.001
72506306|NCT03242759|144544594|OTHER|||||||0.505|||||||Wilcoxon (Mann-Whitney)|||Intra-group difference comparing to baseline was analyzed.||||0.505
72506307|NCT03242759|144544594|OTHER|||||||0.181|||||||Paired t-test|||Intra-group difference comparing to baseline was analyzed.||||0.181
72506308|NCT03242759|144544595|OTHER|||||||0.571|||||||Wilcoxon (Mann-Whitney)|||Intra-group difference comparing to baseline was analyzed.||||0.571
72506309|NCT03242759|144544595|OTHER|||||||0.232|||||||Paired t-test|||Intra-group difference comparing to baseline was analyzed.||||0.232
72506310|NCT03242759|144544596|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Intra-group difference comparing to baseline was analyzed.||||< 0.001
72506311|NCT03242759|144544596|OTHER|||||||0.375|||||||Paired t-test|||Intra-group difference comparing to baseline was analyzed.||||0.375
72506312|NCT03242759|144544597|OTHER|||||||0.027|||||||Wilcoxon (Mann-Whitney)|||Intra-group difference comparing to baseline was analyzed.||||0.027
72506313|NCT03242759|144544597|OTHER|||||||0.938|||||||Wilcoxon (Mann-Whitney)|||Intra-group difference comparing to baseline was analyzed.||||0.938
72506314|NCT03242759|144544598|OTHER|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||Intra-group difference comparing to baseline was analyzed.||||0.001
72506315|NCT03242759|144544598|OTHER|||||||0.048|||||||Paired t-test|||Intra-group difference comparing to baseline was analyzed.||||0.048
72506316|NCT03242759|144544599|OTHER|||||||0.018|||||||Wilcoxon (Mann-Whitney)|||Intra-group difference comparing to baseline was analyzed.||||0.018
72506317|NCT03242759|144544599|OTHER|||||||0.125|||||||Wilcoxon (Mann-Whitney)|||Intra-group difference comparing to baseline was analyzed.||||0.125
72506318|NCT03242759|144544600|OTHER|||||||0.073|||||||Wilcoxon (Mann-Whitney)|||Intra-group difference comparing to baseline was analyzed.||||0.073
72506319|NCT03242759|144544600|OTHER|||||||0.755|||||||Paired t-test|||Intra-group difference comparing to baseline was analyzed.||||0.755
72506320|NCT03242759|144544601|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Intra-group difference comparing to baseline was analyzed.||||< 0.001
72506321|NCT03242759|144544601|OTHER|||||||0.281|||||||Wilcoxon (Mann-Whitney)|||Intra-group difference comparing to baseline was analyzed.||||0.281
72506322|NCT03242759|144544602|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Intra-group difference comparing to baseline was analyzed.||||< 0.001
72622973|NCT02014467|144776226|SUPERIORITY_OR_OTHER|||||||0.6082||95.0||||Treatment By Region Interaction: Based on ANCOVA, Percent change from Baseline = Baseline + treatment + region + treatment by region|ANCOVA|||||||0.6082
72506323|NCT03242759|144544602|OTHER|||||||0.008|||||||Wilcoxon (Mann-Whitney)|||Intra-group difference comparing to baseline was analyzed.||||0.008
72506324|NCT03242759|144544603|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Intra-group difference comparing to baseline was analyzed.||||< 0.001
72506325|NCT03242759|144544603|OTHER|||||||0.031|||||||Wilcoxon (Mann-Whitney)|||Intra-group difference comparing to baseline was analyzed.||||0.031
72506326|NCT03242759|144544605|OTHER||||||<|0.001|||||||Paired t-test|||Intra-group difference comparing to baseline was analyzed.||||< 0.001
72506327|NCT03242759|144544605|OTHER|||||||0.939|||||||Paired t-test|||Intra-group difference comparing to baseline was analyzed.||||0.939
72506328|NCT03242759|144544606|OTHER|||||||0.169|||||||Paired t-test|||Intra-group difference comparing to baseline was analyzed.||||0.169
72506329|NCT03242759|144544606|OTHER|||||||0.545|||||||Paired t-test|||Intra-group difference comparing to baseline was analyzed.||||0.545
72506330|NCT03242759|144544607|OTHER|||||||0.333|||||||Wilcoxon (Mann-Whitney)|||Intra-group difference comparing to baseline was analyzed.||||0.333
72506331|NCT03242759|144544607|OTHER|||||||0.786|||||||Paired t-test|||Intra-group difference comparing to baseline was analyzed.||||0.786
72506332|NCT03242759|144544608|OTHER|||||||0.245|||||||Paired t-test|||Intra-group difference comparing to baseline was analyzed.||||0.245
72506333|NCT03242759|144544608|OTHER|||||||0.454|||||||Paired t-test|||Intra-group difference comparing to baseline was analyzed.||||0.454
72506334|NCT03242759|144544609|OTHER|||||||0.543|||||||Paired t-test|||Intra-group difference comparing to baseline was analyzed.||||0.543
72506335|NCT03242759|144544609|OTHER|||||||0.733|||||||Paired t-test|||Intra-group difference comparing to baseline was analyzed.||||0.733
72506336|NCT03242759|144544610|OTHER|||||||0.046|||||||Paired t-test|||Intra-group difference comparing to baseline was analyzed.||||0.046
72506337|NCT03242759|144544610|OTHER|||||||0.898|||||||Paired t-test|||Intra-group difference comparing to baseline was analyzed.||||0.898
72506338|NCT00336492|144544647|SUPERIORITY_OR_OTHER|||||||0.146|||||||Chi-squared|||||||0.146
72506339|NCT00227877|144544648|SUPERIORITY||Adjusted Relative Risk Ratio|1.39|STANDARD_ERROR_OF_MEAN|0.18|<|0.05|TWO_SIDED|95.0|1.08|1.8|||Regression, Logistic|Group Conditional Risk Ratio adjusting for the multi-site sample design using GEE logistic regression (SUDAAN 10.0)|Risk Ratio: (Intervention Cessation)/(Control Cessation) controlling for age; gender; parent education; number of parents in home; visit type; perceived parent, sibling, and peer substance use; provider gender; and connectedness to provider.|||1.80|1.08|< 0.05
72506340|NCT00227877|144544649|SUPERIORITY||Adjusted Relative Risk Ratio|0.7|STANDARD_ERROR_OF_MEAN|0.25||0.32|TWO_SIDED|95.0|0.34|1.42|||Regression, Logistic|Group Conditional Risk Ratio adjusting for the multi-site sample design using GEE logistic regression (SUDAAN 10.0)|Risk Ratio: (Intervention Initiation)/(Control Initiation) controlling for age; gender; parent education; number of parents in home; visit type; perceived parent, sibling, and peer substance use; provider gender; and connectedness to provider.|||1.42|0.34|.32
72506341|NCT00227877|144544650|SUPERIORITY||Adjusted Relative Risk Ratio|1.8|STANDARD_ERROR_OF_MEAN|0.55||0.05|TWO_SIDED|95.0|0.99|3.27|||Regression, Logistic|Group Conditional Risk Ratio adjusting for the multi-site sample design using GEE logistic regression (SUDAAN 10.0)|||Risk Ratio: (Intervention Cessation)/(Control Cessation) controlling for age; gender; parent education; number of parents in home; visit type; perceived parent, sibling, and peer substance use; provider gender; and connectedness to provider.|3.27|.99|0.05
72622974|NCT02014467|144776227|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.31|||<|0.0001|TWO_SIDED|95.0|2.74|3.88|||ANCOVA|||||3.88|2.74|<0.0001
72472019|NCT02209181|144467321|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|3.14|STANDARD_ERROR_OF_MEAN|0.48|<|0.001|TWO_SIDED|95.0|2.19|4.09||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||4.09|2.19|<0.001
72472020|NCT02209181|144467321|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-2.15|STANDARD_ERROR_OF_MEAN|0.48|<|0.001|TWO_SIDED|95.0|-3.09|-1.21||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||-1.21|-3.09|<0.001
72506342|NCT00227877|144544651|SUPERIORITY||Adjusted Relative Risk Ratio|0.79|STANDARD_ERROR_OF_MEAN|0.16||0.23|TWO_SIDED|95.0|0.53|1.16|||Regression, Logistic|Group Conditional Risk Ratio adjusting for the multi-site sample design using GEE logistic regression (SUDAAN 10.0)|Risk Ratio: (Intervention Initiation)/(Control Initiation) controlling for age; gender; parent education; number of parents in home; visit type; perceived parent, sibling, and peer substance use; provider gender; and connectedness to provider.|||1.16|.53|0.23
72506343|NCT00227877|144544652|SUPERIORITY||Adjusted Relative Risk Ratio|1.52|STANDARD_ERROR_OF_MEAN|0.34||0.07|TWO_SIDED|95.0|0.97|2.36|||Regression, Logistic|Group Conditional Risk Ratio adjusting for the multi-site sample design using GEE logistic regression (SUDAAN 10.0)|Risk Ratio: (Intervention Cessation)/(Control Cessation) controlling for age and gender.|||2.36|.97|.07
72472021|NCT02209181|144467321|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.02|STANDARD_ERROR_OF_MEAN|0.48||0.973|TWO_SIDED|95.0|-0.93|0.97||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.97|-0.93|0.973
72472022|NCT02209181|144467322|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|2.87|STANDARD_ERROR_OF_MEAN|0.51|<|0.001|TWO_SIDED|95.0|1.87|3.87||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||3.87|1.87|<0.001
72472023|NCT02209181|144467322|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.89|STANDARD_ERROR_OF_MEAN|0.5||0.079|TWO_SIDED|95.0|-0.1|1.88||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.88|-0.10|0.079
72472024|NCT02209181|144467322|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|3.27|STANDARD_ERROR_OF_MEAN|0.51|<|0.001|TWO_SIDED|95.0|2.27|4.27||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||4.27|2.27|<0.001
72472025|NCT02209181|144467322|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-1.99|STANDARD_ERROR_OF_MEAN|0.5|<|0.001|TWO_SIDED|95.0|-2.98|-1.0||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||-1.00|-2.98|<0.001
72506344|NCT00227877|144544653|SUPERIORITY||Adjusted Relative Risk Ratio|0.96|STANDARD_ERROR_OF_MEAN|0.41||0.93|TWO_SIDED|95.0|0.42|2.21|||Regression, Logistic||Risk Ratio: (Intervention Initiation)/(Control Initiation) controlling for age and gender.|||2.21|.42|.93
72506345|NCT00227877|144544654|SUPERIORITY||Adjusted Relative Risk Ratio|0.85|STANDARD_ERROR_OF_MEAN|0.5||0.78|TWO_SIDED|95.0|0.27|2.7|||Regression, Logistic|Group Conditional Risk Ratio adjusting for the multi-site sample design using GEE logistic regression (SUDAAN 10.0)|Risk Ratio: (Intervention Cessation)/(Control Cessation) controlling for age and gender.|||2.70|.27|.78
72506346|NCT00227877|144544655|SUPERIORITY||Adjusted Relative Risk Ratio|0.74|STANDARD_ERROR_OF_MEAN|0.15||0.13|TWO_SIDED|95.0|0.51|1.09|||Regression, Logistic|Group Conditional Risk Ratio adjusting for the multi-site sample design using GEE logistic regression (SUDAAN 10.0)|Risk Ratio: (Intervention Initiation)/(Control Initiation) controlling for age and gender.|||1.09|.51|.13
72472026|NCT02209181|144467322|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.39|STANDARD_ERROR_OF_MEAN|0.51||0.44|TWO_SIDED|95.0|-0.61|1.4||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.40|-0.61|0.440
72622975|NCT02014467|144776227|SUPERIORITY_OR_OTHER|||||||0.3513||95.0||||Treatment By Region Interaction: Based on ANCOVA, Percent change from Baseline = Baseline + treatment + region + treatment by region|ANCOVA|||||||0.3513
72472027|NCT02209181|144467323|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|2.55|STANDARD_ERROR_OF_MEAN|0.52|<|0.001|TWO_SIDED|95.0|1.52|3.57||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||3.57|1.52|<0.001
72472028|NCT02209181|144467323|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.81|STANDARD_ERROR_OF_MEAN|0.52||0.118|TWO_SIDED|95.0|-0.21|1.83||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.83|-0.21|0.118
72472029|NCT02209181|144467323|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|3.13|STANDARD_ERROR_OF_MEAN|0.52|<|0.001|TWO_SIDED|95.0|2.1|4.16||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||4.16|2.10|<0.001
72472030|NCT02209181|144467323|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-1.73|STANDARD_ERROR_OF_MEAN|0.52|<|0.001|TWO_SIDED|95.0|-2.75|-0.71||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||-0.71|-2.75|<0.001
72472031|NCT02209181|144467323|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.59|STANDARD_ERROR_OF_MEAN|0.52||0.262|TWO_SIDED|95.0|-0.44|1.62||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.62|-0.44|0.262
72506347|NCT00227877|144544656|SUPERIORITY||Adjusted Relative Risk Ratio|0.66|STANDARD_ERROR_OF_MEAN|0.11||0.66|TWO_SIDED|95.0|0.48|0.91|||Regression, Logistic|Group Conditional Risk Ratio adjusting for the multi-site sample design using GEE logistic regression (SUDAAN 10.0)|Risk Ratio: (Intervention)/(Control) controlling for age; gender; parent education; number of parents in home; visit type; provider gender; connectedness to provider, and baseline DRWI risk.|||.91|.48|.66
72397601|NCT02801942|144301696|OTHER||Mean Difference (Final Values)|12.23|STANDARD_ERROR_OF_MEAN|5.658|||TWO_SIDED|95.0|0.38|24.09|||||The mean difference in myeloid dendritic cells (Healthy participants versus NOT1D participants) in iLN has been presented.|||24.09|0.38|
72472032|NCT02209181|144467324|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|1.92|STANDARD_ERROR_OF_MEAN|0.53|<|0.001|TWO_SIDED|95.0|0.88|2.96||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||2.96|0.88|<0.001
72472033|NCT02209181|144467324|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.58|STANDARD_ERROR_OF_MEAN|0.52||0.271|TWO_SIDED|95.0|-0.45|1.61||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.61|-0.45|0.271
72506348|NCT00227877|144544657|SUPERIORITY||Adjusted Relative Risk Ratio|0.87|STANDARD_ERROR_OF_MEAN|0.13||0.35|TWO_SIDED|95.0|0.64|1.17||Group Conditional Risk Ratio adjusting for the multi-site sample design using GEE logistic regression (SUDAAN 10.0)|Regression, Logistic||Risk Ratio: (Intervention)/(Control) controlling for age; gender; parent education; number of parents in home; visit type; provider gender; connectedness to provider, and baseline DRWI risk.|||1.17|.64|.35
72506349|NCT00227877|144544658|SUPERIORITY||Adjusted Relative Risk Ratio|0.63|STANDARD_ERROR_OF_MEAN|0.1|<|0.01|TWO_SIDED|95.0|0.46|0.87|||Regression, Logistic||Risk Ratio: (Intervention)/(Control) controlling for age; gender; connectedness to provider, and baseline DRWI risk.|||.87|.46|<.01
72506350|NCT00227877|144544659|SUPERIORITY||Adjusted Relative Risk Ratio|0.73|STANDARD_ERROR_OF_MEAN|0.11|<|0.05|TWO_SIDED|95.0|0.54|0.98|||Regression, Logistic||Risk Ratio: (Intervention)/(Control) controlling for age; gender; connectedness to provider, and baseline DRWI risk.|||.98|.54|< 0.05
72506351|NCT02522481|144544666|SUPERIORITY|||||||0.0896|||||||McNemar|||Sensitivity: superiority test comparing CE-DSE and UE-DSE based on the difference||||0.0896
72506352|NCT02522481|144544666|SUPERIORITY||||||<|0.0001|||||||McNemar|||Specificity: superiority test comparing CE-DSE and UE-DSE based on the difference||||<0.0001
72506353|NCT02026908|144544725|OTHER|Paired T- test|p value|0.05||||0.0001|TWO_SIDED|0.0||||P value was calculated with threshold of significance \<0.05.|t-test, 2 sided||A p-value was calculated. Pretreatment (baseline) values for each parameter are compared to post-treatment values in a paired fashion.|||||0.0001
72506354|NCT02026908|144544726|OTHER|Paired t test|p value|0.05||||0.0001|TWO_SIDED|0.0||||P value was calculated and a value of \<0.05 was considered significant. A p-value was calculated. Comments: Pretreatment (baseline) values for each parameter are compared to post-treatment values in a paired fashion.|t-test, 2 sided||P value was calculated with threshold of significance \<0.05.|||||0.0001
72506355|NCT02026908|144544727|OTHER|Paired T test|p value|0.05||||0.0001|TWO_SIDED|0.0||||P value was calculated and a value of \<0.05 was considered significant. A p-value was calculated. Comments: Pretreatment (baseline) values for each parameter are compared to post-treatment values in a paired fashion.|t-test, 2 sided||P value was calculated with threshold of significance \<0.05.|||||0.0001
72506356|NCT02026908|144544728|OTHER|Paired T Test|p value|0.05||||0.0001|TWO_SIDED|||||P value was calculated and a value of \<0.05 was considered significant. A p-value was calculated. Comments: Pretreatment (baseline) values for each parameter are compared to post-treatment values in a paired fashion.|t-test, 2 sided|||||||0.0001
72506357|NCT02026908|144544729|OTHER|Paired T test|p value|0.05||||0.008|TWO_SIDED|0.0||||P value was calculated and a value of \<0.05 was considered significant. A p-value was calculated. Comments: Pretreatment (baseline) values for each parameter are compared to post-treatment values in a paired fashion.|t-test, 2 sided||P value was calculated and a value of \<0.05 was considered significant. A p-value was calculated. Comments: Pretreatment (baseline) values for each parameter are compared to post-treatment values in a paired fashion.|||||0.008
72506358|NCT04003155|144544754|SUPERIORITY||LSMean Difference|-1.87|STANDARD_ERROR_OF_MEAN|0.42|<|0.001||95.0|-2.69|-1.05||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Least squares Mean (LSM), Standard error (SE), Confidence interval (CI), Mixed model repeated measures (MMRM), Change from Baseline (CFB), Dependent variable (dv), Treatment (tr), Week (wk), Baseline (bl), Weight (wt)||-1.05|-2.69|<0.001
72506359|NCT04003155|144544754|SUPERIORITY||LSMean Difference|-2.07|STANDARD_ERROR_OF_MEAN|0.42|<|0.001||95.0|-2.89|-1.25||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||||-1.25|-2.89|<0.001
72506360|NCT04003155|144544754|SUPERIORITY|||||||0.012|||||||Hochberg|||||||0.012
72397602|NCT02801942|144301696|OTHER||Mean Difference (Final Values)|-10.87|STANDARD_ERROR_OF_MEAN|6.961|||TWO_SIDED|95.0|-25.52|3.78|||||The mean difference in plasmacytoid dendritic cells (Healthy participants versus NOT1D participants) in iLN has been presented.|||3.78|-25.52|
72397603|NCT02801942|144301699|OTHER||Mean Difference (Final Values)|1.79|STANDARD_ERROR_OF_MEAN|6.329|||TWO_SIDED|95.0|-11.41|14.99|||||The mean difference in CD45RA+ Effector Memory CD8 (Healthy participants versus NOT1D participants) in blood has been presented.|||14.99|-11.41|
72506361|NCT04003155|144544754|SUPERIORITY|||||||0.007|||||||Hochberg|||||||0.007
72622976|NCT02014467|144776228|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.62|||<|0.0001|TWO_SIDED|95.0|1.96|3.27|||ANCOVA|||||3.27|1.96|<0.0001
72472034|NCT02209181|144467324|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|2.95|STANDARD_ERROR_OF_MEAN|0.53|<|0.001|TWO_SIDED|95.0|1.91|3.99||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||3.99|1.91|<0.001
72397604|NCT02801942|144301699|OTHER||Mean Difference (Final Values)|0.15|STANDARD_ERROR_OF_MEAN|2.28|||TWO_SIDED|95.0|-4.6|4.91|||||The mean difference in Central Memory CD8 (Healthy participants versus NOT1D participants) in blood has been presented.|||4.91|-4.60|
72472035|NCT02209181|144467324|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-1.34|STANDARD_ERROR_OF_MEAN|0.52||0.011|TWO_SIDED|95.0|-2.37|-0.32||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||-0.32|-2.37|0.011
72472036|NCT02209181|144467324|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|1.03|STANDARD_ERROR_OF_MEAN|0.53||0.052|TWO_SIDED|95.0|-0.01|2.07||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||2.07|-0.01|0.052
72397605|NCT02801942|144301699|OTHER||Mean Difference (Final Values)|4.38|STANDARD_ERROR_OF_MEAN|3.297|||TWO_SIDED|95.0|-2.5|11.26|||||The mean difference in Effector Memory CD8 (Healthy participants versus NOT1D participants) in blood has been presented.|||11.26|-2.50|
72472037|NCT02209181|144467325|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|1.25|STANDARD_ERROR_OF_MEAN|0.53||0.018|TWO_SIDED|95.0|0.21|2.29||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||2.29|0.21|0.018
72472038|NCT02209181|144467325|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.53|STANDARD_ERROR_OF_MEAN|0.52||0.31|TWO_SIDED|95.0|-0.5|1.56||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.56|-0.50|0.310
72472039|NCT02209181|144467325|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|2.8|STANDARD_ERROR_OF_MEAN|0.53|<|0.001|TWO_SIDED|95.0|1.76|3.85||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||3.85|1.76|<0.001
72472040|NCT02209181|144467325|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.72|STANDARD_ERROR_OF_MEAN|0.52||0.172|TWO_SIDED|95.0|-1.75|0.31||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.31|-1.75|0.172
72472041|NCT02209181|144467325|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|1.55|STANDARD_ERROR_OF_MEAN|0.53||0.004|TWO_SIDED|95.0|0.51|2.6||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||2.60|0.51|0.004
72506362|NCT04003155|144544755|SUPERIORITY||LSMean difference|-2.39|STANDARD_ERROR_OF_MEAN|0.44|<|0.001||95.0|-3.25|-1.52||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||||-1.52|-3.25|<0.001
72506363|NCT04003155|144544755|SUPERIORITY||LSMean Difference|-2.55|STANDARD_ERROR_OF_MEAN|0.43|<|0.001||95.0|-3.4|-1.7||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||||-1.70|-3.40|<0.001
72506364|NCT04003155|144544755|SUPERIORITY|||||||0.012|||||||Hochberg|||||||0.012
72506365|NCT04003155|144544755|SUPERIORITY|||||||0.007|||||||Hochberg|||||||0.007
72397606|NCT02801942|144301699|OTHER||Mean Difference (Final Values)|-6.06|STANDARD_ERROR_OF_MEAN|5.729|||TWO_SIDED|95.0|-18.01|5.89|||||The mean difference in Naive CD8 (Healthy participants versus NOT1D participants) in blood has been presented.|||5.89|-18.01|
72397607|NCT02801942|144301699|OTHER||Mean Difference (Final Values)|-0.03|STANDARD_ERROR_OF_MEAN|0.305|||TWO_SIDED|95.0|-0.67|0.6|||||The mean difference in Stem Cell Memory-like CD8 (Healthy participants versus NOT1D participants) in blood has been presented.|||0.60|-0.67|
72506366|NCT04003155|144544756|SUPERIORITY||LSMean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.06||0.012||95.0|-0.27|-0.03||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||||-0.03|-0.27|0.012
72622977|NCT02014467|144776228|SUPERIORITY_OR_OTHER|||||||0.541||95.0||||Treatment By Region Interaction: Based on ANCOVA, Percent change from Baseline = Baseline + treatment + region + treatment by region|ANCOVA|||||||0.5410
72397608|NCT02801942|144301700|OTHER||Mean Difference (Final Values)|1.2|STANDARD_ERROR_OF_MEAN|3.133|||TWO_SIDED|95.0|-5.33|7.73|||||The mean difference in CD45RA+ Effector Memory CD8 (Healthy participants versus NOT1D participants) in iLN has been presented.|||7.73|-5.33|
72472042|NCT02209181|144467326|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.84|STANDARD_ERROR_OF_MEAN|0.51||0.102|TWO_SIDED|95.0|-0.17|1.84||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.84|-0.17|0.102
72472043|NCT02209181|144467326|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.36|STANDARD_ERROR_OF_MEAN|0.51||0.479|TWO_SIDED|95.0|-0.64|1.35||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.35|-0.64|0.479
72472044|NCT02209181|144467326|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|2.85|STANDARD_ERROR_OF_MEAN|0.51|<|0.001|TWO_SIDED|95.0|1.85|3.86||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||3.86|1.85|<0.001
72622978|NCT02014467|144776229|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.72|||<|0.0001|TWO_SIDED|95.0|3.71|5.72|||ANCOVA|||||5.72|3.71|<0.0001
72622979|NCT02014467|144776229|SUPERIORITY_OR_OTHER|||||||0.3957||95.0||||Treatment By Region Interaction: Based on ANCOVA, Percent change from Baseline = Baseline + treatment + region + treatment by region|ANCOVA|||||||0.3957
72397609|NCT02801942|144301700|OTHER||Mean Difference (Final Values)|-0.66|STANDARD_ERROR_OF_MEAN|1.466|||TWO_SIDED|95.0|-3.73|2.41|||||The mean difference in Central Memory CD8 (Healthy participants versus NOT1D participants) in iLN has been presented.|||2.41|-3.73|
72397610|NCT02801942|144301700|OTHER||Mean Difference (Final Values)|-1.85|STANDARD_ERROR_OF_MEAN|2.79|||TWO_SIDED|95.0|-7.67|3.96|||||The mean difference in Effector Memory CD8 (Healthy participants versus NOT1D participants) in iLN has been presented.|||3.96|-7.67|
72397611|NCT02801942|144301700|OTHER||Mean Difference (Final Values)|0.67|STANDARD_ERROR_OF_MEAN|6.342|||TWO_SIDED|95.0|-12.54|13.87|||||The mean difference in Naive CD8 (Healthy participants versus NOT1D participants) in iLN has been presented.|||13.87|-12.54|
72397612|NCT02801942|144301700|OTHER||Mean Difference (Final Values)|-0.67|STANDARD_ERROR_OF_MEAN|0.492|||TWO_SIDED|95.0|-1.71|0.36|||||The mean difference in Stem Cell Memory-like CD8 (Healthy participants versus NOT1D participants) in iLN has been presented.|||0.36|-1.71|
72397613|NCT02801942|144301703|OTHER||Mean Difference (Final Values)|-0.34|STANDARD_ERROR_OF_MEAN|0.236|||TWO_SIDED|95.0|-0.84|0.16|||||The mean difference in PD-1+ ICOS+ TFH cells (Healthy participants versus NOT1D participants) in blood has been presented.|||0.16|-0.84|
72397614|NCT02801942|144301704|OTHER||Mean Difference (Final Values)|-6.21|STANDARD_ERROR_OF_MEAN|4.362|||TWO_SIDED|95.0|-15.37|2.96|||||The mean difference in PD-1+ ICOS+ TFH cells (Healthy participants versus NOT1D participants) in iLN has been presented.|||2.96|-15.37|
72472045|NCT02209181|144467326|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.48|STANDARD_ERROR_OF_MEAN|0.51||0.345|TWO_SIDED|95.0|-1.47|0.52||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.52|-1.47|0.345
72397615|NCT02801942|144301705|OTHER||Mean Difference (Final Values)|1.03|STANDARD_ERROR_OF_MEAN|1.269|||TWO_SIDED|95.0|-1.61|3.68|||||The mean difference in CD45RA+ Effector Memory Conv T cells (Healthy participants versus NOT1D participants) in blood has been presented.|||3.68|-1.61|
72397616|NCT02801942|144301705|OTHER||Mean Difference (Final Values)|-1.54|STANDARD_ERROR_OF_MEAN|3.152|||TWO_SIDED|95.0|-8.12|5.03|||||The mean difference in Central Memory Conv T cells (Healthy participants versus NOT1D participants) in blood has been presented.|||5.03|-8.12|
72397617|NCT02801942|144301705|OTHER||Mean Difference (Final Values)|-0.23|STANDARD_ERROR_OF_MEAN|2.089|||TWO_SIDED|95.0|-4.59|4.13|||||The mean difference in Effector Memory Conv T cells (Healthy participants versus NOT1D participants) in blood has been presented.|||4.13|-4.59|
72397618|NCT02801942|144301705|OTHER||Mean Difference (Final Values)|0.92|STANDARD_ERROR_OF_MEAN|3.835|||TWO_SIDED|95.0|-7.08|8.92|||||The mean difference in Naive Conv T cells (Healthy participants versus NOT1D participants) in blood has been presented.|||8.92|-7.08|
72397619|NCT02801942|144301705|OTHER||Mean Difference (Final Values)|-0.09|STANDARD_ERROR_OF_MEAN|0.145|||TWO_SIDED|95.0|-0.4|0.21|||||The mean difference in Stem Cell Memory-like Conv T cells (Healthy participants versus NOT1D participants) in blood has been presented.|||0.21|-0.40|
72397620|NCT02801942|144301706|OTHER||Mean Difference (Final Values)|0.26|STANDARD_ERROR_OF_MEAN|0.236||||95.0|-0.23|0.75|||||The mean difference in CD45RA+ Effector Memory Conv T cells (Healthy participants versus NOT1D participants) in iLN has been presented.|||0.75|-0.23|
72397621|NCT02801942|144301706|OTHER||Mean Difference (Final Values)|-1.95|STANDARD_ERROR_OF_MEAN|3.943|||TWO_SIDED|95.0|-10.2|6.29|||||The mean difference in Central Memory Conv T cells (Healthy participants versus NOT1D participants) in iLN has been presented.|||6.29|-10.20|
72397622|NCT02801942|144301706|OTHER||Mean Difference (Final Values)|2.15|STANDARD_ERROR_OF_MEAN|3.621|||TWO_SIDED|95.0|-5.38|9.69|||||The mean difference in Effector Memory Conv T cells(Healthy participants versus NOT1D participants) in iLN has been presented.|||9.69|-5.38|
72397623|NCT02801942|144301706|OTHER||Mean Difference (Final Values)|-0.8|STANDARD_ERROR_OF_MEAN|4.629|||TWO_SIDED|95.0|-10.47|8.86|||||The mean difference in Naive Conv T cells (Healthy participants versus NOT1D participants) in iLN has been presented.|||8.86|-10.47|
72397624|NCT02801942|144301706|OTHER||Mean Difference (Final Values)|-0.21|STANDARD_ERROR_OF_MEAN|0.268|||TWO_SIDED|95.0|-0.77|0.34|||||The mean difference in Stem cell Memory-like Conv T cells (Healthy participants versus NOT1D participants) in iLN has been presented.|||0.34|-0.77|
72397625|NCT02801942|144301707|OTHER||Mean Difference (Final Values)|-5.09|STANDARD_ERROR_OF_MEAN|2.556|||TWO_SIDED|95.0|-10.42|0.25|||||The mean difference in TFH cells (Healthy participants versus NOT1D participants) in blood has been presented.|||0.25|-10.42|
72397626|NCT02801942|144301707|OTHER||Mean Difference (Final Values)|-0.04|STANDARD_ERROR_OF_MEAN|0.05|||TWO_SIDED|95.0|-0.15|0.07|||||The mean difference in PD-1+ ICOS+ TFH cells (Healthy participants versus NOT1D participants) in blood has been presented.|||0.07|-0.15|
72397627|NCT02801942|144301707|OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|1.428|||TWO_SIDED|95.0|-3.08|2.88|||||The mean difference in TH17 cells (Healthy participants versus NOT1D participants) in blood has been presented.|||2.88|-3.08|
72397628|NCT02801942|144301707|OTHER||Mean Difference (Final Values)|2.09|STANDARD_ERROR_OF_MEAN|4.294|||TWO_SIDED|95.0|-6.87|11.05|||||The mean difference in TH1 cells (Healthy participants versus NOT1D participants) in blood has been presented.|||11.05|-6.87|
72397629|NCT02801942|144301707|OTHER||Mean Difference (Final Values)|0.03|STANDARD_ERROR_OF_MEAN|2.382|||TWO_SIDED|95.0|-4.94|5.0|||||The mean difference in TH1 TH17 cells (Healthy participants versus NOT1D participants) in blood has been presented.|||5.00|-4.94|
72472046|NCT02209181|144467326|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|2.01|STANDARD_ERROR_OF_MEAN|0.51|<|0.001|TWO_SIDED|95.0|1.01|3.02||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||3.02|1.01|<0.001
72472047|NCT02209181|144467327|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.49|STANDARD_ERROR_OF_MEAN|0.51||0.338|TWO_SIDED|95.0|-0.52|1.51||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.51|-0.52|0.338
72472048|NCT02209181|144467327|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.53|STANDARD_ERROR_OF_MEAN|0.51||0.299|TWO_SIDED|95.0|-0.47|1.54||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.54|-0.47|0.299
72472049|NCT02209181|144467327|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|2.72|STANDARD_ERROR_OF_MEAN|0.52|<|0.001|TWO_SIDED|95.0|1.7|3.73||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||3.73|1.70|<0.001
72472050|NCT02209181|144467327|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.04|STANDARD_ERROR_OF_MEAN|0.51||0.942|TWO_SIDED|95.0|-0.97|1.04||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.04|-0.97|0.942
72472051|NCT02209181|144467327|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|2.22|STANDARD_ERROR_OF_MEAN|0.52|<|0.001|TWO_SIDED|95.0|1.21|3.24||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||3.24|1.21|<0.001
72472052|NCT02209181|144467328|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.52|STANDARD_ERROR_OF_MEAN|0.51||0.306|TWO_SIDED|95.0|-0.48|1.53||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.53|-0.48|0.306
72472053|NCT02209181|144467328|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.49|STANDARD_ERROR_OF_MEAN|0.51||0.335|TWO_SIDED|95.0|-0.51|1.49||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.49|-0.51|0.335
72472054|NCT02209181|144467328|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|2.79|STANDARD_ERROR_OF_MEAN|0.51|<|0.001|TWO_SIDED|95.0|1.78|3.8||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||3.80|1.78|<0.001
72506367|NCT04003155|144544756|SUPERIORITY||LSMean Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.06||0.002||95.0|-0.3|-0.07||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||||-0.07|-0.30|0.002
72506368|NCT04003155|144544756|SUPERIORITY|||||||0.012|||||||Hochberg|||||||0.012
72506369|NCT04003155|144544756|SUPERIORITY|||||||0.007|||||||Hochberg|||||||0.007
72506370|NCT04003155|144544757|SUPERIORITY||LSMean Difference|-0.24|STANDARD_ERROR_OF_MEAN|0.08||0.002||95.0|-0.39|-0.09||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||||-0.09|-0.39|0.002
72506371|NCT04003155|144544757|SUPERIORITY||LSMean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.08||0.007||95.0|-0.35|-0.06||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||||-0.06|-0.35|0.007
72506372|NCT04003155|144544757|SUPERIORITY|||||||0.012|||||||Hochberg|||||||0.012
72397630|NCT02801942|144301707|OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|1.112|||TWO_SIDED|95.0|-2.31|2.32|||||The mean difference in TH1 TH17 TH2 T cells (Healthy participants versus NOT1D participants) in blood has been presented.|||2.32|-2.31|
72472055|NCT02209181|144467328|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.51||0.946|TWO_SIDED|95.0|-1.03|0.97||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.97|-1.03|0.946
72472056|NCT02209181|144467328|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|2.27|STANDARD_ERROR_OF_MEAN|0.51|<|0.001|TWO_SIDED|95.0|1.25|3.28||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||3.28|1.25|<0.001
72397631|NCT02801942|144301707|OTHER||Mean Difference (Final Values)|-0.59|STANDARD_ERROR_OF_MEAN|1.026|||TWO_SIDED|95.0|-2.73|1.55|||||The mean difference in TH1 TH2 cells (Healthy participants versus NOT1D participants) in blood has been presented.|||1.55|-2.73|
72472057|NCT02209181|144467329|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.55|STANDARD_ERROR_OF_MEAN|0.51||0.279|TWO_SIDED|95.0|-0.45|1.56||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.56|-0.45|0.279
72472058|NCT02209181|144467329|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.54|STANDARD_ERROR_OF_MEAN|0.51||0.292|TWO_SIDED|95.0|-0.46|1.53||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.53|-0.46|0.292
72472059|NCT02209181|144467329|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|2.67|STANDARD_ERROR_OF_MEAN|0.51|<|0.001|TWO_SIDED|95.0|1.66|3.68||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||3.68|1.66|<0.001
72472060|NCT02209181|144467329|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.51||0.971|TWO_SIDED|95.0|-1.02|0.98||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.98|-1.02|0.971
72472061|NCT02209181|144467329|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|2.11|STANDARD_ERROR_OF_MEAN|0.51|<|0.001|TWO_SIDED|95.0|1.11|3.12||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||3.12|1.11|<0.001
72506373|NCT04003155|144544757|SUPERIORITY|||||||0.007|||||||Hochberg|||||||0.007
72472062|NCT02209181|144467330|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.5|STANDARD_ERROR_OF_MEAN|0.51||0.329|TWO_SIDED|95.0|-0.5|1.5||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.50|-0.50|0.329
72472063|NCT02209181|144467330|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.32|STANDARD_ERROR_OF_MEAN|0.5||0.531|TWO_SIDED|95.0|-0.68|1.31||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.31|-0.68|0.531
72472064|NCT02209181|144467330|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|2.53|STANDARD_ERROR_OF_MEAN|0.51|<|0.001|TWO_SIDED|95.0|1.53|3.54||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||3.54|1.53|<0.001
72472065|NCT02209181|144467330|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.5||0.722|TWO_SIDED|95.0|-1.17|0.81||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.81|-1.17|0.722
72472066|NCT02209181|144467330|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|2.04|STANDARD_ERROR_OF_MEAN|0.51|<|0.001|TWO_SIDED|95.0|1.03|3.04||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||3.04|1.03|<0.001
72472067|NCT02209181|144467331|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.44|STANDARD_ERROR_OF_MEAN|0.5||0.38|TWO_SIDED|95.0|-0.54|1.42||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.42|-0.54|0.380
72472068|NCT02209181|144467331|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.15|STANDARD_ERROR_OF_MEAN|0.49||0.767|TWO_SIDED|95.0|-0.83|1.12||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.12|-0.83|0.767
72472069|NCT02209181|144467331|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|2.5|STANDARD_ERROR_OF_MEAN|0.5|<|0.001|TWO_SIDED|95.0|1.52|3.49||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||3.49|1.52|<0.001
72472070|NCT02209181|144467331|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.29|STANDARD_ERROR_OF_MEAN|0.49||0.557|TWO_SIDED|95.0|-1.27|0.68||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.68|-1.27|0.557
72472071|NCT02209181|144467331|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|2.06|STANDARD_ERROR_OF_MEAN|0.5|<|0.001|TWO_SIDED|95.0|1.08|3.05||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||3.05|1.08|<0.001
72506374|NCT04003155|144544758|SUPERIORITY||LSMean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.8||0.489||95.0|-2.0|1.0||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||||1.0|-2.0|0.489
72622980|NCT02014467|144776230|SUPERIORITY_OR_OTHER||Hodges Lehmann Estimate of Difference|-56.92|||<|0.0001|TWO_SIDED|95.0|-61.38|-52.65||Two-Sided, Wilcoxon t Approximation|Wilcoxon Rank Sum test||s-CTX at Month 6|||-52.65|-61.38|<0.0001
72622981|NCT02014467|144776230|SUPERIORITY_OR_OTHER||Hodges Lehmann Estimate of Difference|-52.56|||<|0.0001||95.0|-59.38|-46.17||Two-Sided, Wilcoxon t Approximation|Wilcoxon Rank Sum test||s-CTX at Month 12|||-46.17|-59.38|<0.0001
72472072|NCT02209181|144467332|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.26|STANDARD_ERROR_OF_MEAN|0.55||0.64|TWO_SIDED|95.0|-0.83|1.35||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.35|-0.83|0.640
72472073|NCT02209181|144467332|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.14|STANDARD_ERROR_OF_MEAN|0.55||0.798|TWO_SIDED|95.0|-0.94|1.22||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.22|-0.94|0.798
72472074|NCT02209181|144467332|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|2.32|STANDARD_ERROR_OF_MEAN|0.55|<|0.001|TWO_SIDED|95.0|1.23|3.42||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||3.42|1.23|<0.001
72472075|NCT02209181|144467332|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.55||0.829|TWO_SIDED|95.0|-1.2|0.96||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.96|-1.20|0.829
72472076|NCT02209181|144467332|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|2.06|STANDARD_ERROR_OF_MEAN|0.55|<|0.001|TWO_SIDED|95.0|0.97|3.16||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||3.16|0.97|<0.001
72472077|NCT02209181|144467333|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.25|STANDARD_ERROR_OF_MEAN|0.16||0.117|TWO_SIDED|95.0|-0.06|0.57||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.57|-0.06|0.117
72472078|NCT02209181|144467333|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.06|STANDARD_ERROR_OF_MEAN|0.16||0.687|TWO_SIDED|95.0|-0.25|0.38||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.38|-0.25|0.687
72472079|NCT02209181|144467333|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.11|STANDARD_ERROR_OF_MEAN|0.16||0.497|TWO_SIDED|95.0|-0.21|0.43||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.43|-0.21|0.497
72472080|NCT02209181|144467333|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.16||0.239|TWO_SIDED|95.0|-0.51|0.13||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.13|-0.51|0.239
72472081|NCT02209181|144467333|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.16||0.376|TWO_SIDED|95.0|-0.46|0.18||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.18|-0.46|0.376
72472082|NCT02209181|144467334|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|1.78|STANDARD_ERROR_OF_MEAN|0.32|<|0.001|TWO_SIDED|95.0|1.14|2.42||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||2.42|1.14|<0.001
72472083|NCT02209181|144467334|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|0.32||0.35|TWO_SIDED|95.0|-0.33|0.94||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.94|-0.33|0.350
72472084|NCT02209181|144467334|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.43|STANDARD_ERROR_OF_MEAN|0.33||0.183|TWO_SIDED|95.0|-0.21|1.08||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.08|-0.21|0.183
72472085|NCT02209181|144467334|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-1.48|STANDARD_ERROR_OF_MEAN|0.32|<|0.001|TWO_SIDED|95.0|-2.11|-0.84||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||-0.84|-2.11|<0.001
72506375|NCT04003155|144544758|SUPERIORITY||LSMean Difference|-1.1|STANDARD_ERROR_OF_MEAN|0.7||0.155||95.0|-2.5|0.4||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||||0.4|-2.5|0.155
72506376|NCT04003155|144544759|SUPERIORITY||LSMean difference|-1.81|STANDARD_ERROR_OF_MEAN|0.37|<|0.001|TWO_SIDED|95.0|-2.53|-1.09||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 1||-1.09|-2.53|<0.001
72506377|NCT04003155|144544759|SUPERIORITY||LSMean Difference|-1.25|STANDARD_ERROR_OF_MEAN|0.37|<|0.001|TWO_SIDED|95.0|-1.97|-0.53||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 1||-0.53|-1.97|<0.001
72506378|NCT04003155|144544759|SUPERIORITY||LSMean Difference|-1.97|STANDARD_ERROR_OF_MEAN|0.4|<|0.001|TWO_SIDED|95.0|-2.75|-1.19||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 2||-1.19|-2.75|<0.001
72506379|NCT04003155|144544759|SUPERIORITY||LSMean Difference|-1.83|STANDARD_ERROR_OF_MEAN|0.39|<|0.001|TWO_SIDED|95.0|-2.6|-1.05||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 2||-1.05|-2.60|<0.001
72506380|NCT04003155|144544759|SUPERIORITY||LSMean Difference|-1.99|STANDARD_ERROR_OF_MEAN|0.41|<|0.001|TWO_SIDED|95.0|-2.79|-1.19||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 3||-1.19|-2.79|<0.001
72565774|NCT02709486|144662698|SUPERIORITY||Least Square Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.17|<|0.0001|TWO_SIDED|95.0|-1.14|-0.46|||ANCOVA|||Week 12: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC stiffness subscales and baseline diary average pain as covariates, and study site as a random effect.||-0.46|-1.14|<.0001
72565775|NCT02709486|144662698|SUPERIORITY||Least Square Mean Difference|-0.84|STANDARD_ERROR_OF_MEAN|0.17|<|0.0001|TWO_SIDED|95.0|-1.18|-0.5|||ANCOVA|||Week 12: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC stiffness subscales and baseline diary average pain as covariates, and study site as a random effect.||-0.50|-1.18|<.0001
72622982|NCT02014467|144776231|SUPERIORITY_OR_OTHER||Hodges Lehmann Estimate of Difference|-56.94|||<|0.0001|TWO_SIDED|95.0|-61.6|-52.7||Two-Sided, Wilcoxon t Approximation|Wilcoxon Rank Sum test||s-PINP at Month 6|||-52.70|-61.60|<0.0001
72472086|NCT02209181|144467334|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-1.34|STANDARD_ERROR_OF_MEAN|0.33|<|0.001|TWO_SIDED|95.0|-1.98|-0.7||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||-0.70|-1.98|<0.001
72397632|NCT02801942|144301707|OTHER||Mean Difference (Final Values)|1.57|STANDARD_ERROR_OF_MEAN|1.474|||TWO_SIDED|95.0|-1.51|4.64|||||The mean difference in TH2 cells (Healthy participants versus NOT1D participants) in blood has been presented.|||4.64|-1.51|
72472087|NCT02209181|144467335|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|3.78|STANDARD_ERROR_OF_MEAN|0.42|<|0.001|TWO_SIDED|95.0|2.94|4.61||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||4.61|2.94|<0.001
72472088|NCT02209181|144467335|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.88|STANDARD_ERROR_OF_MEAN|0.42||0.037|TWO_SIDED|95.0|0.05|1.71||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.71|0.05|0.037
72472089|NCT02209181|144467335|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|1.47|STANDARD_ERROR_OF_MEAN|0.43|<|0.001|TWO_SIDED|95.0|0.63|2.3||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||2.30|0.63|<0.001
72472090|NCT02209181|144467335|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-2.9|STANDARD_ERROR_OF_MEAN|0.42|<|0.001|TWO_SIDED|95.0|-3.73|-2.07||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||-2.07|-3.73|<0.001
72472091|NCT02209181|144467335|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-2.31|STANDARD_ERROR_OF_MEAN|0.43|<|0.001|TWO_SIDED|95.0|-3.15|-1.47||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||-1.47|-3.15|<0.001
72472092|NCT02209181|144467336|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|4.34|STANDARD_ERROR_OF_MEAN|0.46|<|0.001|TWO_SIDED|95.0|3.43|5.25||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||5.25|3.43|<0.001
72472093|NCT02209181|144467336|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.85|STANDARD_ERROR_OF_MEAN|0.46||0.067|TWO_SIDED|95.0|-0.06|1.75||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.75|-0.06|0.067
72472094|NCT02209181|144467336|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|2.26|STANDARD_ERROR_OF_MEAN|0.46|<|0.001|TWO_SIDED|95.0|1.34|3.17||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||3.17|1.34|<0.001
72472095|NCT02209181|144467336|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-3.49|STANDARD_ERROR_OF_MEAN|0.46|<|0.001|TWO_SIDED|95.0|-4.4|-2.59||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||-2.59|-4.40|<0.001
72397633|NCT02801942|144301707|OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.504|||TWO_SIDED|95.0|-1.05|1.05|||||The mean difference in TH22 cells (Healthy participants versus NOT1D participants) in blood has been presented.|||1.05|-1.05|
72397634|NCT02801942|144301708|OTHER||Mean Difference (Final Values)|1.54|STANDARD_ERROR_OF_MEAN|3.607|||TWO_SIDED|95.0|-5.99|9.07|||||The mean difference in TFH cells (Healthy participants versus NOT1D participants) in iLN has been presented.|||9.07|-5.99|
72397635|NCT02801942|144301708|OTHER||Mean Difference (Final Values)|-0.62|STANDARD_ERROR_OF_MEAN|0.855|||TWO_SIDED|95.0|-2.43|1.18|||||The mean difference in PD-1+ ICOS+ TFH cells (Healthy participants versus NOT1D participants) in iLN has been presented.|||1.18|-2.43|
72472096|NCT02209181|144467336|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-2.08|STANDARD_ERROR_OF_MEAN|0.46|<|0.001|TWO_SIDED|95.0|-3.0|-1.17||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||-1.17|-3.00|<0.001
72472097|NCT02209181|144467337|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|4.87|STANDARD_ERROR_OF_MEAN|0.49|<|0.001|TWO_SIDED|95.0|3.9|5.84||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||5.84|3.90|<0.001
72472098|NCT02209181|144467337|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|1.13|STANDARD_ERROR_OF_MEAN|0.49||0.023|TWO_SIDED|95.0|0.16|2.09||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||2.09|0.16|0.023
72472099|NCT02209181|144467337|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|2.96|STANDARD_ERROR_OF_MEAN|0.5|<|0.001|TWO_SIDED|95.0|1.98|3.93||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||3.93|1.98|<0.001
72472100|NCT02209181|144467337|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-3.75|STANDARD_ERROR_OF_MEAN|0.49|<|0.001|TWO_SIDED|95.0|-4.71|-2.78||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||-2.78|-4.71|<0.001
72472101|NCT02209181|144467337|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-1.91|STANDARD_ERROR_OF_MEAN|0.5|<|0.001|TWO_SIDED|95.0|-2.89|-0.94||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||-0.94|-2.89|<0.001
72622983|NCT02014467|144776231|SUPERIORITY_OR_OTHER||Hodges Lehmann Estimate of Difference|-51.21|||<|0.0001|TWO_SIDED|95.0|-56.26|-45.91||Two-Sided, Wilcoxon t Approximation|Wilcoxon Rank Sum test||s-PINP at Month 12|||-45.91|-56.26|<0.0001
72622984|NCT02069847|144776250|SUPERIORITY|||||||0.992|||||||ANOVA|||||||0.992
72506381|NCT04003155|144544759|SUPERIORITY||LSMean Difference|-2.1|STANDARD_ERROR_OF_MEAN|0.4|<|0.001|TWO_SIDED|95.0|-2.9|-1.31||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 3||-1.31|-2.90|<0.001
72506382|NCT04003155|144544759|SUPERIORITY||LSMean Difference|-2.07|STANDARD_ERROR_OF_MEAN|0.41|<|0.001|TWO_SIDED|95.0|-2.87|-1.27||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 5||-1.27|-2.87|<0.001
72506383|NCT04003155|144544759|SUPERIORITY||LSMean Difference|-2.18|STANDARD_ERROR_OF_MEAN|0.4|<|0.001|TWO_SIDED|95.0|-2.98|-1.39||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 5||-1.39|-2.98|<0.001
72506384|NCT04003155|144544759|SUPERIORITY||LSMean Difference|-2.11|STANDARD_ERROR_OF_MEAN|0.41|<|0.001|TWO_SIDED|95.0|-2.92|-1.3||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 6||-1.30|-2.92|<0.001
72506385|NCT04003155|144544759|SUPERIORITY||LSMean Difference|-2.39|STANDARD_ERROR_OF_MEAN|0.41|<|0.001|TWO_SIDED|95.0|-3.19|-1.59||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 6||-1.59|-3.19|<0.001
72506386|NCT04003155|144544759|SUPERIORITY||LSMean Difference|-2.1|STANDARD_ERROR_OF_MEAN|0.43|<|0.001|TWO_SIDED|95.0|-2.95|-1.25||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 7||-1.25|-2.95|<0.001
72506387|NCT04003155|144544759|SUPERIORITY||LSMean Difference|-2.27|STANDARD_ERROR_OF_MEAN|0.43|<|0.001|TWO_SIDED|95.0|-3.11|-1.42||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 7||-1.42|-3.11|<0.001
72506388|NCT04003155|144544759|SUPERIORITY||LSMean Difference|-2.39|STANDARD_ERROR_OF_MEAN|0.43|<|0.001|TWO_SIDED|95.0|-3.25|-1.54||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 8||-1.54|-3.25|<0.001
72506389|NCT04003155|144544759|SUPERIORITY||LSMean Difference|-2.39|STANDARD_ERROR_OF_MEAN|0.43|<|0.001|TWO_SIDED|95.0|-3.23|-1.55||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 8||-1.55|-3.23|<0.001
72506390|NCT04003155|144544759|SUPERIORITY||LSMean Difference|-2.08|STANDARD_ERROR_OF_MEAN|0.43|<|0.001|TWO_SIDED|95.0|-2.93|-1.22||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 9||-1.22|-2.93|<0.001
72506391|NCT04003155|144544759|SUPERIORITY||LSMean Difference|-2.16|STANDARD_ERROR_OF_MEAN|0.43|<|0.001|TWO_SIDED|95.0|-3.0|-1.31||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 9||-1.31|-3.00|<0.001
72506392|NCT04003155|144544759|SUPERIORITY||LSMean Difference|-2.21|STANDARD_ERROR_OF_MEAN|0.43|<|0.001|TWO_SIDED|95.0|-3.05|-1.37||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 10||-1.37|-3.05|<0.001
72506393|NCT04003155|144544759|SUPERIORITY||LSMean Difference|-2.16|STANDARD_ERROR_OF_MEAN|0.42|<|0.001|TWO_SIDED|95.0|-2.98|-1.33||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 10||-1.33|-2.98|<0.001
72506394|NCT04003155|144544759|SUPERIORITY||LSMean Difference|-2.48|STANDARD_ERROR_OF_MEAN|0.44|<|0.001|TWO_SIDED|95.0|-3.34|-1.62||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 11||-1.62|-3.34|<0.001
72506395|NCT04003155|144544759|SUPERIORITY||LSMean Difference|-2.45|STANDARD_ERROR_OF_MEAN|0.43|<|0.001|TWO_SIDED|95.0|-3.3|-1.6||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 11||-1.60|-3.30|<0.001
72506396|NCT04003155|144544760|SUPERIORITY||LSMean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.04||0.006|TWO_SIDED|95.0|-0.17|-0.03||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 1||-0.03|-0.17|0.006
72506397|NCT04003155|144544760|SUPERIORITY||LSMean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.04||0.006|TWO_SIDED|95.0|-0.17|-0.03||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 1||-0.03|-0.17|0.006
72506398|NCT04003155|144544760|SUPERIORITY||LSMean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.05||0.003|TWO_SIDED|95.0|-0.24|-0.05||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 2||-0.05|-0.24|0.003
72506399|NCT04003155|144544760|SUPERIORITY||LSMean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.05||0.002|TWO_SIDED|95.0|-0.25|-0.06||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 2||-0.06|-0.25|0.002
72397636|NCT02801942|144301708|OTHER||Mean Difference (Final Values)|0.41|STANDARD_ERROR_OF_MEAN|1.391|||TWO_SIDED|95.0|-2.49|3.31|||||The mean difference in TH17 cells (Healthy participants versus NOT1D participants) in iLN has been presented.|||3.31|-2.49|
72506400|NCT04003155|144544760|SUPERIORITY||LSMean Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.06||0.004|TWO_SIDED|95.0|-0.27|-0.05||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 3||-0.05|-0.27|0.004
72506401|NCT04003155|144544760|SUPERIORITY||LSMean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.06||0.003|TWO_SIDED|95.0|-0.28|-0.06||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 3||-0.06|-0.28|0.003
72506402|NCT04003155|144544760|SUPERIORITY||LSMean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.06||0.006|TWO_SIDED|95.0|-0.29|-0.05||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 5||-0.05|-0.29|0.006
72506403|NCT04003155|144544760|SUPERIORITY||LSMean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.06||0.004|TWO_SIDED|95.0|-0.29|-0.06||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 5||-0.06|-0.29|0.004
72506404|NCT04003155|144544760|SUPERIORITY||LSMean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.07||0.003|TWO_SIDED|95.0|-0.33|-0.07||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 6||-0.07|-0.33|0.003
72506405|NCT04003155|144544760|SUPERIORITY||LSMean Difference|-0.25|STANDARD_ERROR_OF_MEAN|0.06|<|0.001|TWO_SIDED|95.0|-0.38|-0.13||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 6||-0.13|-0.38|<0.001
72506406|NCT04003155|144544760|SUPERIORITY||LSMean Difference|-0.24|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|95.0|-0.37|-0.11||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 7||-0.11|-0.37|<0.001
72506407|NCT04003155|144544760|SUPERIORITY||LSMean Difference|-0.26|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|95.0|-0.39|-0.13||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 7||-0.13|-0.39|<0.001
72506408|NCT04003155|144544760|SUPERIORITY||LSMean Difference|-0.28|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|95.0|-0.41|-0.15||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 8||-0.15|-0.41|<0.001
72397637|NCT02801942|144301708|OTHER||Mean Difference (Final Values)|-3.5|STANDARD_ERROR_OF_MEAN|2.824|||TWO_SIDED|95.0|-9.39|2.39|||||The mean difference in TH1 cells (Healthy participants versus NOT1D participants) in iLN has been presented.|||2.39|-9.39|
72506409|NCT04003155|144544760|SUPERIORITY||LSMean Difference|-0.24|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|95.0|-0.37|-0.11||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 8||-0.11|-0.37|<0.001
72506410|NCT04003155|144544760|SUPERIORITY||MMRM|-0.26|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|95.0|-0.41|-0.12||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 9||-0.12|-0.41|<0.001
72506411|NCT04003155|144544760|SUPERIORITY||LSMean Difference|-0.21|STANDARD_ERROR_OF_MEAN|0.07||0.004|TWO_SIDED|95.0|-0.35|-0.06||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 9||-0.06|-0.35|0.004
72506412|NCT04003155|144544760|SUPERIORITY||LSMean Difference|-0.28|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-0.43|-0.13||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 10||-0.13|-0.43|<0.001
72506413|NCT04003155|144544760|SUPERIORITY||LSMean Difference|-0.23|STANDARD_ERROR_OF_MEAN|0.07||0.002|TWO_SIDED|95.0|-0.37|-0.08||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 10||-0.08|-0.37|0.002
72506414|NCT04003155|144544760|SUPERIORITY||LSMean Difference|-0.27|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-0.43|-0.12||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 11||-0.12|-0.43|<0.001
72622985|NCT02069847|144776251|SUPERIORITY|||||||0.531|||||||t-test, 2 sided|||Total number of budesonide subjects with 50% or greater esophageal stricture (N=4) vs total number of control subjects with 50% or greater esophageal structure (N=15)||||0.531
72397638|NCT02801942|144301708|OTHER||Mean Difference (Final Values)|0.24|STANDARD_ERROR_OF_MEAN|0.738|||TWO_SIDED|95.0|-1.29|1.78|||||The mean difference in TH1 TH17 cells (Healthy participants versus NOT1D participants) in iLN has been presented.|||1.78|-1.29|
72506415|NCT04003155|144544760|SUPERIORITY||LSMean Difference|-0.24|STANDARD_ERROR_OF_MEAN|0.08||0.002|TWO_SIDED|95.0|-0.4|-0.09||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 11||-0.09|-0.40|0.002
72506416|NCT04003155|144544761|SUPERIORITY||LSMean Difference|-15.52|STANDARD_ERROR_OF_MEAN|3.29|<|0.001|TWO_SIDED|95.0|-21.99|-9.06||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 1||-9.06|-21.99|<0.001
72506417|NCT04003155|144544761|SUPERIORITY||LSMean Difference|-12.22|STANDARD_ERROR_OF_MEAN|3.3|<|0.001|TWO_SIDED|95.0|-18.69|-5.74||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 1||-5.74|-18.69|<0.001
72506418|NCT04003155|144544761|SUPERIORITY||LSMean Difference|-17.3|STANDARD_ERROR_OF_MEAN|3.57|<|0.001|TWO_SIDED|95.0|-24.32|-10.27||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 2||-10.27|-24.32|<0.001
72506419|NCT04003155|144544761|SUPERIORITY||LSMean Difference|-18.29|STANDARD_ERROR_OF_MEAN|3.57|<|0.001|TWO_SIDED|95.0|-25.3|-11.29||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 2||-11.29|-25.30|<0.001
72506420|NCT04003155|144544761|SUPERIORITY||LSMean Difference|-18.13|STANDARD_ERROR_OF_MEAN|3.63|<|0.001|TWO_SIDED|95.0|-25.25|-11.0||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 3||-11.00|-25.25|<0.001
72397639|NCT02801942|144301708|OTHER||Mean Difference (Final Values)|0.4|STANDARD_ERROR_OF_MEAN|0.544|||TWO_SIDED|95.0|-0.73|1.54|||||The mean difference in TH1 TH17 TH2 T cells (Healthy participants versus NOT1D participants) in iLN has been presented.|||1.54|-0.73|
72397640|NCT02801942|144301708|OTHER||Mean Difference (Final Values)|0.48|STANDARD_ERROR_OF_MEAN|1.246|||TWO_SIDED|95.0|-2.12|3.07|||||The mean difference in TH1 TH2 cells (Healthy participants versus NOT1D participants) in iLN has been presented.|||3.07|-2.12|
72565776|NCT02709486|144662698|SUPERIORITY||Least Square Mean Difference|-0.65|STANDARD_ERROR_OF_MEAN|0.18||0.0002|TWO_SIDED|95.0|-1.0|-0.3|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC stiffness subscales and baseline diary average pain as covariates, and study site as a random effect.||-0.30|-1.00|0.0002
72397641|NCT02801942|144301708|OTHER||Mean Difference (Final Values)|3.05|STANDARD_ERROR_OF_MEAN|2.641|||TWO_SIDED|95.0|-2.45|8.55|||||The mean difference in TH2 cells (Healthy participants versus NOT1D participants) in iLN has been presented.|||8.55|-2.45|
72397642|NCT02801942|144301708|OTHER||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.448|||TWO_SIDED|95.0|-0.92|0.96|||||The mean difference in TH22 cells (Healthy participants versus NOT1D participants) in iLN has been presented.|||0.96|-0.92|
72397643|NCT02801942|144301709|OTHER||Mean Difference (Final Values)|-4.83|STANDARD_ERROR_OF_MEAN|2.82|||TWO_SIDED|95.0|-10.71|1.05|||||The mean difference in TFH cells-like Reg T cells (Healthy participants versus NOT1D participants) in blood has been presented.|||1.05|-10.71|
72397644|NCT02801942|144301709|OTHER||Mean Difference (Final Values)|-0.83|STANDARD_ERROR_OF_MEAN|0.953|||TWO_SIDED|95.0|-2.82|1.16|||||The mean difference in TH1 cells-like Reg T cells (Healthy participants versus NOT1D participants) in blood has been presented.|||1.16|-2.82|
72397645|NCT02801942|144301709|OTHER||Mean Difference (Final Values)|-2.88|STANDARD_ERROR_OF_MEAN|1.536||||95.0|-6.08|0.33|||||The mean difference in TH1 TH17 TH2 cells-like Reg T cells (Healthy participants versus NOT1D participants) in blood has been presented.|||0.33|-6.08|
72397646|NCT02801942|144301709|OTHER||Mean Difference (Final Values)|1.81|STANDARD_ERROR_OF_MEAN|0.963|||TWO_SIDED|95.0|-0.2|3.81|||||The mean difference in TH1 TH2 cells-like Reg T cells (Healthy participants versus NOT1D participants) in blood has been presented.|||3.81|-0.20|
72506421|NCT04003155|144544761|SUPERIORITY||LSMean Difference|-21.19|STANDARD_ERROR_OF_MEAN|3.61|<|0.001|TWO_SIDED|95.0|-28.29|-14.09||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 3||-14.09|-28.29|<0.001
72506422|NCT04003155|144544761|SUPERIORITY||LSMean Difference|-16.75|STANDARD_ERROR_OF_MEAN|3.81|<|0.001|TWO_SIDED|95.0|-24.24|-9.26||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 4||-9.26|-24.24|<0.001
72506423|NCT04003155|144544761|SUPERIORITY||LSMean Difference|-21.05|STANDARD_ERROR_OF_MEAN|3.79|<|0.001|TWO_SIDED|95.0|-28.5|-13.61||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 4||-13.61|-28.50|<0.001
72506424|NCT04003155|144544761|SUPERIORITY||LSMean Difference|-17.57|STANDARD_ERROR_OF_MEAN|3.79|<|0.001|TWO_SIDED|95.0|-25.02|-10.12||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 5||-10.12|-25.02|<0.001
72622986|NCT04805593|144776279|SUPERIORITY|Superiority testing was conducted to confirm the proportion is higher than the targeted value of 50%.|||||<|0.0001|||||||Exact Test of Binomial Proportion|||||||<0.0001
72506425|NCT04003155|144544761|SUPERIORITY||LSMean Difference|-21.78|STANDARD_ERROR_OF_MEAN|3.76|<|0.001|TWO_SIDED|95.0|-29.18|-14.39||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 5||-14.39|-29.18|<0.001
72506426|NCT04003155|144544761|SUPERIORITY||LSMean Difference|-18.39|STANDARD_ERROR_OF_MEAN|3.89|<|0.001|TWO_SIDED|95.0|-26.03|-10.75||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 6||-10.75|-26.03|<0.001
72506427|NCT04003155|144544761|SUPERIORITY||LSMean Difference|-23.83|STANDARD_ERROR_OF_MEAN|3.85|<|0.001|TWO_SIDED|95.0|-31.39|-16.27||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 6||-16.27|-31.39|<0.001
72506428|NCT04003155|144544761|SUPERIORITY||LSMean Difference|-18.29|STANDARD_ERROR_OF_MEAN|4.09|<|0.001|TWO_SIDED|95.0|-26.33|-10.25||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 7||-10.25|-26.33|<0.001
72506429|NCT04003155|144544761|SUPERIORITY||LSMean Difference|-21.41|STANDARD_ERROR_OF_MEAN|4.04|<|0.001|TWO_SIDED|95.0|-29.35|-13.48||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 7||-13.48|-29.35|<0.001
72506430|NCT04003155|144544761|SUPERIORITY||LSMean Difference|-20.16|STANDARD_ERROR_OF_MEAN|4.06|<|0.001|TWO_SIDED|95.0|-28.14|-12.19||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 8||-12.19|-28.14|<0.001
72506431|NCT04003155|144544761|SUPERIORITY||LSMean Difference|-21.17|STANDARD_ERROR_OF_MEAN|4.01|<|0.001|TWO_SIDED|95.0|-29.04|-13.3||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 8||-13.30|-29.04|<0.001
72506432|NCT04003155|144544761|SUPERIORITY||LSMean Difference|-16.67|STANDARD_ERROR_OF_MEAN|4.1|<|0.001|TWO_SIDED|95.0|-24.73|-8.61||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 9||-8.61|-24.73|<0.001
72506433|NCT04003155|144544761|SUPERIORITY||LSMean Difference|-18.89|STANDARD_ERROR_OF_MEAN|4.05|<|0.001|TWO_SIDED|95.0|-26.84|-10.94||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 9||-10.94|-26.84|<0.001
72506434|NCT04003155|144544761|SUPERIORITY||LSMean Difference|-17.88|STANDARD_ERROR_OF_MEAN|4.01|<|0.001|TWO_SIDED|95.0|-25.77|-9.99||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 10||-9.99|-25.77|<0.001
72506435|NCT04003155|144544761|SUPERIORITY||LSMean Difference|-19.5|STANDARD_ERROR_OF_MEAN|3.96|<|0.001|TWO_SIDED|95.0|-27.28|-11.72||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 10||-11.72|-27.28|<0.001
72506436|NCT04003155|144544761|SUPERIORITY||LSMean Difference|-20.32|STANDARD_ERROR_OF_MEAN|4.06|<|0.001|TWO_SIDED|95.0|-28.3|-12.35||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 11||-12.35|-28.30|<0.001
72506437|NCT04003155|144544761|SUPERIORITY||LSMean Difference|-22.14|STANDARD_ERROR_OF_MEAN|4.0|<|0.001|TWO_SIDED|95.0|-30.0|-14.28||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 11||-14.28|-30.00|<0.001
72565777|NCT02709486|144662698|SUPERIORITY||Least Square Mean Difference|-0.77|STANDARD_ERROR_OF_MEAN|0.18|<|0.0001|TWO_SIDED|95.0|-1.12|-0.43|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC stiffness subscales and baseline diary average pain as covariates, and study site as a random effect.||-0.43|-1.12|<.0001
72397647|NCT02801942|144301709|OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|1.289|||TWO_SIDED|95.0|-2.99|2.39|||||The mean difference in TH17 cells-like Reg T cells (Healthy participants versus NOT1D participants) in blood has been presented.|||2.39|-2.99|
72506438|NCT04003155|144544761|SUPERIORITY||LSMean Difference|-20.08|STANDARD_ERROR_OF_MEAN|4.13|<|0.001|TWO_SIDED|95.0|-28.19|-11.96||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 12||-11.96|-28.19|<0.001
72506439|NCT04003155|144544761|SUPERIORITY||LSMean Difference|-24.18|STANDARD_ERROR_OF_MEAN|4.06|<|0.001|TWO_SIDED|95.0|-32.16|-16.2||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 12||-16.20|-32.16|<0.001
72622987|NCT04805593|144776280|SUPERIORITY|Superiority testing was conducted to confirm the proportion is higher than the targeted value of 75%.|||||<|0.0001|||||||Exact Test of Binomial Proportion|||||||<0.0001
72397648|NCT02801942|144301709|OTHER||Mean Difference (Final Values)|3.38|STANDARD_ERROR_OF_MEAN|1.907|||TWO_SIDED|95.0|-0.59|7.36|||||The mean difference in TH2 cells-like Reg T cells (Healthy participants versus NOT1D participants) in blood has been presented.|||7.36|-0.59|
72397649|NCT02801942|144301709|OTHER||Mean Difference (Final Values)|-1.16|STANDARD_ERROR_OF_MEAN|1.413|||TWO_SIDED|95.0|-4.11|1.78|||||The mean difference in TH22 cells-like Reg T cells (Healthy participants versus NOT1D participants) in blood has been presented.|||1.78|-4.11|
72397650|NCT02801942|144301710|OTHER||Mean Difference (Final Values)|0.51|STANDARD_ERROR_OF_MEAN|2.918|||TWO_SIDED|95.0|-5.6|6.63|||||The mean difference in TFH cells-like Reg T cells (Healthy participants versus NOT1D participants) in iLN has been presented.|||6.63|-5.60|
72397651|NCT02801942|144301710|OTHER||Mean Difference (Final Values)|-4.1|STANDARD_ERROR_OF_MEAN|1.842|||TWO_SIDED|95.0|-7.93|-0.26|||||The mean difference in TH1 cells-like Reg T cells (Healthy participants versus NOT1D participants) in iLN has been presented.|||-0.26|-7.93|
72506440|NCT04003155|144544762|SUPERIORITY||Odds Ratio (OR)|3.245|||<|0.001|TWO_SIDED|95.0|1.823|5.999||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 1||5.999|1.823|<0.001
72506441|NCT04003155|144544762|SUPERIORITY||Odds Ratio (OR)|2.964|||<|0.001|TWO_SIDED|95.0|1.658|5.497||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 1||5.497|1.658|<0.001
72506442|NCT04003155|144544762|SUPERIORITY||Odds Ratio (OR)|2.187||||0.001|TWO_SIDED|95.0|1.363|3.549||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 2||3.549|1.363|0.001
72506443|NCT04003155|144544762|SUPERIORITY||Odds Ratio (OR)|2.847|||<|0.001|TWO_SIDED|95.0|1.786|4.601||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 2||4.601|1.786|<0.001
72565778|NCT02709486|144662698|SUPERIORITY||Least Square Mean Difference|-0.62|STANDARD_ERROR_OF_MEAN|0.19||0.0013|TWO_SIDED|95.0|-0.99|-0.24|||ANCOVA|||Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.||-0.24|-0.99|0.0013
72565779|NCT02709486|144662698|SUPERIORITY||Least Square Mean Difference|-0.87|STANDARD_ERROR_OF_MEAN|0.19|<|0.0001|TWO_SIDED|95.0|-1.25|-0.5|||ANCOVA|||Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC stiffness subscales and baseline diary average pain as covariates, and study site as a random effect.||-0.50|-1.25|<.0001
72397652|NCT02801942|144301710|OTHER||Mean Difference (Final Values)|-1.55|STANDARD_ERROR_OF_MEAN|1.209|||TWO_SIDED|95.0|-4.34|1.24|||||The mean difference in TH1 TH17 TH2 cells-like Reg T cells (Healthy participants versus NOT1D participants) in iLN has been presented.|||1.24|-4.34|
72397653|NCT02801942|144301710|OTHER||Mean Difference (Final Values)|-0.87|STANDARD_ERROR_OF_MEAN|1.725|||TWO_SIDED|95.0|-4.51|2.77|||||The mean difference in TH1 TH2 cells-like Reg T cells (Healthy participants versus NOT1D participants) in iLN has been presented.|||2.77|-4.51|
72397654|NCT02801942|144301710|OTHER||Mean Difference (Final Values)|-0.47|STANDARD_ERROR_OF_MEAN|2.193|||TWO_SIDED|95.0|-5.02|4.09|||||The mean difference in TH17 cells-like Reg T cells (Healthy participants versus NOT1D participants) in iLN has been presented.|||4.09|-5.02|
72397655|NCT02801942|144301710|OTHER||Mean Difference (Final Values)|0.58|STANDARD_ERROR_OF_MEAN|3.405|||TWO_SIDED|95.0|-6.52|7.68|||||The mean difference in TH2 cells-like Reg T cells (Healthy participants versus NOT1D participants) in iLN has been presented.|||7.68|-6.52|
72397656|NCT02801942|144301710|OTHER||Mean Difference (Final Values)|-0.41|STANDARD_ERROR_OF_MEAN|0.811|||TWO_SIDED|95.0|-2.21|1.4|||||The mean difference in TH22 cells-like Reg T cells (Healthy participants versus NOT1D participants) in iLN has been presented.|||1.40|-2.21|
72397657|NCT02801942|144301711|OTHER||Mean Difference (Final Values)|0.4|STANDARD_ERROR_OF_MEAN|0.601|||TWO_SIDED|95.0|-0.86|1.65|||||The mean difference in Reg T cells (Healthy participants versus NOT1D participants) in blood has been presented.|||1.65|-0.86|
72397658|NCT02801942|144301712|OTHER||Mean Difference (Final Values)|-0.24|STANDARD_ERROR_OF_MEAN|0.929|||TWO_SIDED|95.0|-2.18|1.7|||||The mean difference in Reg T cells (Healthy participants versus NOT1D participants) in iLN has been presented.|||1.70|-2.18|
72397659|NCT02801942|144301713|OTHER||Mean Difference (Final Values)|0.95|STANDARD_ERROR_OF_MEAN|0.443|||TWO_SIDED|95.0|0.02|1.87|||||The mean difference in CD69+ CD8 cells (Healthy participants versus NOT1D participants) in blood has been presented.|||1.87|0.02|
72397660|NCT02801942|144301713|OTHER||Mean Difference (Final Values)|-0.83|STANDARD_ERROR_OF_MEAN|0.58|||TWO_SIDED|95.0|-2.04|0.38|||||The mean difference in Ki67+ CD8 cells (Healthy participants versus NOT1D participants) in blood has been presented.|||0.38|-2.04|
72506444|NCT04003155|144544762|SUPERIORITY||Odds Ratio (OR)|2.096||||0.002|TWO_SIDED|95.0|1.326|3.345||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 3||3.345|1.326|0.002
72506445|NCT04003155|144544762|SUPERIORITY||Odds Ratio (OR)|3.333|||<|0.001|TWO_SIDED|95.0|2.121|5.302||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 3||5.302|2.121|<0.001
72506446|NCT04003155|144544762|SUPERIORITY||Odds Ratio (OR)|2.061||||0.001|TWO_SIDED|95.0|1.323|3.233||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 4||3.233|1.323|0.001
72506447|NCT04003155|144544762|SUPERIORITY||Odds Ratio (OR)|3.025|||<|0.001|TWO_SIDED|95.0|1.947|4.746||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 4||4.746|1.947|<0.001
72622988|NCT03464461|144776282|OTHER|non-parametric||||||0.9844|||||||Kruskal-Wallis|||||||0.9844
72506448|NCT04003155|144544762|SUPERIORITY||Odds Ratio (OR)|2.13|||<|0.001|TWO_SIDED|95.0|1.363|3.357||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 5||3.357|1.363|<0.001
72397661|NCT02801942|144301714|OTHER||Mean Difference (Final Values)|-2.77|STANDARD_ERROR_OF_MEAN|4.299|||TWO_SIDED|95.0|-11.81|6.27|||||The mean difference in CD69+ CD8 cells (Healthy participants versus NOT1D participants) in iLN has been presented.|||6.27|-11.81|
72397662|NCT02801942|144301714|OTHER||Mean Difference (Final Values)|2.2|STANDARD_ERROR_OF_MEAN|1.051|||TWO_SIDED|95.0|-0.04|4.44|||||The mean difference in Ki67+ CD8 cells (Healthy participants versus NOT1D participants) in iLN has been presented.|||4.44|-0.04|
72397663|NCT02801942|144301715|OTHER||Mean Difference (Final Values)|-1.29|STANDARD_ERROR_OF_MEAN|2.214|||TWO_SIDED|95.0|-5.91|3.32|||||The mean difference in CD15s+ Reg T cells (Healthy participants versus NOT1D participants) in blood has been presented.|||3.32|-5.91|
72506449|NCT04003155|144544762|SUPERIORITY||Odds Ratio (OR)|3.223|||<|0.001|TWO_SIDED|95.0|2.067|5.08||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 5||5.080|2.067|<0.001
72397664|NCT02801942|144301715|OTHER||Mean Difference (Final Values)|0.92|STANDARD_ERROR_OF_MEAN|0.308|||TWO_SIDED|95.0|0.28|1.57|||||The mean difference in CD69+ Reg T cells (Healthy participants versus NOT1D participants) in blood has been presented.|||1.57|0.28|
72565780|NCT02709486|144662700|SUPERIORITY||Least Square Mean Difference|-0.71|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-0.96|-0.45|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC average scores and baseline diary average pain as covariates, and study site as a random effect.||-0.45|-0.96|<.0001
72565781|NCT02709486|144662700|SUPERIORITY||Least Square Mean Difference|-0.47|STANDARD_ERROR_OF_MEAN|0.13||0.0004|TWO_SIDED|95.0|-0.73|-0.21|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC average scores and baseline diary average pain as covariates, and study site as a random effect.||-0.21|-0.73|0.0004
72397665|NCT02801942|144301715|OTHER||Mean Difference (Final Values)|4.21|STANDARD_ERROR_OF_MEAN|3.017|||TWO_SIDED|95.0|-2.08|10.51|||||The mean difference in Helios+ Reg T cells (Healthy participants versus NOT1D participants) in blood has been presented.|||10.51|-2.08|
72397666|NCT02801942|144301715|OTHER||Mean Difference (Final Values)|-0.98|STANDARD_ERROR_OF_MEAN|0.985|||TWO_SIDED|95.0|-3.03|1.08|||||The mean difference in Ki67+ T Reg cells (Healthy participants versus NOT1D participants) in blood has been presented.|||1.08|-3.03|
72397667|NCT02801942|144301715|OTHER||Mean Difference (Final Values)|-4.86|STANDARD_ERROR_OF_MEAN|3.802|||TWO_SIDED|95.0|-12.8|3.07|||||The mean difference in Memory Reg T cells (Healthy participants versus NOT1D participants) in blood has been presented.|||3.07|-12.80|
72397668|NCT02801942|144301715|OTHER||Mean Difference (Final Values)|8.6|STANDARD_ERROR_OF_MEAN|4.733|||TWO_SIDED|95.0|-1.27|18.47|||||The mean difference in Resting Reg T cells (Healthy participants versus NOT1D participants) in blood has been presented.|||18.47|-1.27|
72397669|NCT02801942|144301716|OTHER||Mean Difference (Final Values)|6.53|STANDARD_ERROR_OF_MEAN|4.905||||95.0|-3.78|16.85|||||The mean difference in CD15s+ Reg T cells (Healthy participants versus NOT1D participants) in blood has been presented.|||16.85|-3.78|
72397670|NCT02801942|144301716|OTHER||Mean Difference (Final Values)|-8.54|STANDARD_ERROR_OF_MEAN|4.595|||TWO_SIDED|95.0|-18.17|1.1|||||The mean difference in CD69+ Reg T cells (Healthy participants versus NOT1D participants) in blood has been presented.|||1.10|-18.17|
72397671|NCT02801942|144301716|OTHER||Mean Difference (Final Values)|2.11|STANDARD_ERROR_OF_MEAN|2.519|||TWO_SIDED|95.0|-3.23|7.45|||||The mean difference in Helios+ Reg T cells (Healthy participants versus NOT1D participants) in blood has been presented.|||7.45|-3.23|
72397672|NCT02801942|144301716|OTHER||Mean Difference (Final Values)|3.3|STANDARD_ERROR_OF_MEAN|2.02|||TWO_SIDED|95.0|-0.98|7.59|||||The mean difference in Ki67+ T Reg cells (Healthy participants versus NOT1D participants) in blood has been presented.|||7.59|-0.98|
72506450|NCT04003155|144544762|SUPERIORITY||Odds Ratio (OR)|2.049||||0.002|TWO_SIDED|95.0|1.317|3.21||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 6||3.210|1.317|0.002
72397673|NCT02801942|144301716|OTHER||Mean Difference (Final Values)|0.22|STANDARD_ERROR_OF_MEAN|4.026|||TWO_SIDED|95.0|-8.23|8.67|||||The mean difference in Memory Reg T cells (Healthy participants versus NOT1D participants) in blood has been presented.|||8.67|-8.23|
72397674|NCT02801942|144301716|OTHER||Mean Difference (Final Values)|8.31|STANDARD_ERROR_OF_MEAN|4.595|||TWO_SIDED|95.0|-1.32|17.95|||||The mean difference in Resting Reg T cells (Healthy participants versus NOT1D participants) in blood has been presented.|||17.95|-1.32|
72397675|NCT02801942|144301717|OTHER||Mean Difference (Final Values)|0.32|STANDARD_ERROR_OF_MEAN|0.601|||TWO_SIDED|95.0|-0.94|1.57|||||The mean difference in CD15s+ Conv T cells (Healthy participants versus NOT1D participants) in blood has been presented.|||1.57|-0.94|
72397676|NCT02801942|144301717|OTHER||Mean Difference (Final Values)|0.64|STANDARD_ERROR_OF_MEAN|0.306|||TWO_SIDED|95.0|0.0|1.28|||||The mean difference in CD69+ Conv T cells (Healthy participants versus NOT1D participants) in blood has been presented.|||1.28|0.00|
72397677|NCT02801942|144301717|OTHER||Mean Difference (Final Values)|0.39|STANDARD_ERROR_OF_MEAN|0.345|||TWO_SIDED|95.0|-0.33|1.11|||||The mean difference in Helios+ Conv T cells (Healthy participants versus NOT1D participants) in blood has been presented.|||1.11|-0.33|
72397678|NCT02801942|144301717|OTHER||Mean Difference (Final Values)|-0.15|STANDARD_ERROR_OF_MEAN|0.3|||TWO_SIDED|95.0|-0.78|0.47|||||The mean difference in Ki67+ Conv T cells (Healthy participants versus NOT1D participants) in blood has been presented.|||0.47|-0.78|
72506451|NCT04003155|144544762|SUPERIORITY||Odds Ratio (OR)|3.097|||<|0.001|TWO_SIDED|95.0|1.994|4.858||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 6||4.858|1.994|<0.001
72622989|NCT03464461|144776283|OTHER|non-parametric||||||0.158|||||||Kruskal-Wallis|||||||0.1580
72622990|NCT03464461|144776284|OTHER|non-parametric||||||0.873|||||||Kruskal-Wallis|||||||0.8730
72506452|NCT04003155|144544762|SUPERIORITY||Odds Ratio (OR)|1.984||||0.002|TWO_SIDED|95.0|1.28|3.097||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 7||3.097|1.280|0.002
72506453|NCT04003155|144544762|SUPERIORITY||Odds Ratio (OR)|3.062|||<|0.001|TWO_SIDED|95.0|1.977|4.788||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 7||4.788|1.977|<0.001
72506454|NCT04003155|144544762|SUPERIORITY||Odds Ratio (OR)|2.748|||<|0.001|TWO_SIDED|95.0|1.774|4.294||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 8||4.294|1.774|<0.001
72506455|NCT04003155|144544762|SUPERIORITY||Odds Ratio (OR)|2.379|||<|0.001|TWO_SIDED|95.0|1.536|3.712||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 8||3.712|1.536|<0.001
72397679|NCT02801942|144301718|OTHER||Mean Difference (Final Values)|1.78|STANDARD_ERROR_OF_MEAN|0.989|||TWO_SIDED|95.0|-0.3|3.86|||||The mean difference in CD15s+ Conv T cells (Healthy participants versus NOT1D participants) in iLN has been presented.|||3.86|-0.30|
72397680|NCT02801942|144301718|OTHER||Mean Difference (Final Values)|-2.55|STANDARD_ERROR_OF_MEAN|4.716|||TWO_SIDED|95.0|-12.45|7.35|||||The mean difference in CD69+ Conv T cells (Healthy participants versus NOT1D participants) in iLN has been presented.|||7.35|-12.45|
72397681|NCT02801942|144301718|OTHER||Mean Difference (Final Values)|0.14|STANDARD_ERROR_OF_MEAN|0.957|||TWO_SIDED|95.0|-1.86|2.14|||||The mean difference in Helios+ Conv T cells (Healthy participants versus NOT1D participants) in iLN has been presented.|||2.14|-1.86|
72397682|NCT02801942|144301718|OTHER||Mean Difference (Final Values)|2.74|STANDARD_ERROR_OF_MEAN|0.872|||TWO_SIDED|95.0|0.9|4.58|||||The mean difference in Ki67+ Conv T cells (Healthy participants versus NOT1D participants) in iLN has been presented.|||4.58|0.90|
72397683|NCT02801942|144301719|OTHER||Mean Difference (Final Values)|0.57|STANDARD_ERROR_OF_MEAN|1.344|||TWO_SIDED|95.0|-2.23|3.38|||||The mean difference in CD15s+ Memory Conv T cells (Healthy participants versus NOT1D participants) in blood has been presented.|||3.38|-2.23|
72397684|NCT02801942|144301719|OTHER||Mean Difference (Final Values)|0.84|STANDARD_ERROR_OF_MEAN|0.351|||TWO_SIDED|95.0|0.1|1.57|||||The mean difference in CD69+ Memory Conv T cells (Healthy participants versus NOT1D participants) in blood has been presented.|||1.57|0.10|
72397685|NCT02801942|144301719|OTHER||Mean Difference (Final Values)|0.83|STANDARD_ERROR_OF_MEAN|0.594|||TWO_SIDED|95.0|-0.41|2.07|||||The mean difference in Helios+ Memory Conv T cells (Healthy participants versus NOT1D participants) in blood has been presented.|||2.07|-0.41|
72397686|NCT02801942|144301719|OTHER||Mean Difference (Final Values)|-0.31|STANDARD_ERROR_OF_MEAN|0.589|||TWO_SIDED|95.0|-1.54|0.92|||||The mean difference in Ki67+ Memory Conv T cells (Healthy participants versus NOT1D participants) in blood has been presented.|||0.92|-1.54|
72397687|NCT02801942|144301720|OTHER||Mean Difference (Final Values)|3.01|STANDARD_ERROR_OF_MEAN|1.728|||TWO_SIDED|95.0|-0.62|6.63|||||The mean difference in CD15s+ Memory Conv T cells (Healthy participants versus NOT1D participants) in iLN has been presented.|||6.63|-0.62|
72397688|NCT02801942|144301720|OTHER||Mean Difference (Final Values)|-2.06|STANDARD_ERROR_OF_MEAN|4.392|||TWO_SIDED|95.0|-11.33|7.21|||||The mean difference in CD69+ Memory Conv T cells (Healthy participants versus NOT1D participants) in iLN has been presented.|||7.21|-11.33|
72397689|NCT02801942|144301720|OTHER||Mean Difference (Final Values)|1.28|STANDARD_ERROR_OF_MEAN|2.042|||TWO_SIDED|95.0|-14.56|17.13|||||The mean difference in Helios+ Memory Conv T cells (Healthy participants versus NOT1D participants) in iLN has been presented.|||17.13|-14.56|
72397690|NCT02801942|144301720|OTHER||Mean Difference (Final Values)|2.14|STANDARD_ERROR_OF_MEAN|0.843|||TWO_SIDED|95.0|0.36|3.92|||||The mean difference in Ki67+ Memory Conv T cells (Healthy participants versus NOT1D participants) in iLN has been presented.|||3.92|0.36|
72397691|NCT02801942|144301721|OTHER||Mean Difference (Final Values)|2.29|STANDARD_ERROR_OF_MEAN|3.097|||TWO_SIDED|95.0|-4.24|8.83|||||The mean difference in Circulating B Lymphocytes (Healthy participants versus NOT1D participants) by FNA method has been presented.|||8.83|-4.24|
72397692|NCT02801942|144301721|OTHER||Mean Difference (Final Values)|4.46|STANDARD_ERROR_OF_MEAN|2.334|||TWO_SIDED|95.0|-0.47|9.39|||||The mean difference in Circulating B Lymphocytes (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||9.39|-0.47|
72397693|NCT02801942|144301721|OTHER||Mean Difference (Final Values)|11.54|STANDARD_ERROR_OF_MEAN|7.693|||TWO_SIDED|95.0|-5.24|28.32|||||The mean difference in Classical B Lymphocytes (Healthy participants versus NOT1D participants) by FNA method has been presented.|||28.32|-5.24|
72397694|NCT02801942|144301721|OTHER||Mean Difference (Final Values)|5.64|STANDARD_ERROR_OF_MEAN|6.0|||TWO_SIDED|95.0|-7.73|19.01|||||The mean difference in Classical B Lymphocytes (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||19.01|-7.73|
72397695|NCT02801942|144301721|OTHER||Mean Difference (Final Values)|-1.37|STANDARD_ERROR_OF_MEAN|3.336|||TWO_SIDED|95.0|-8.46|5.71|||||The mean difference in Double Negative B Lymphocytes (Healthy participants versus NOT1D participants) by FNA method has been presented.|||5.71|-8.46|
72506456|NCT04003155|144544762|SUPERIORITY||Odds Ratio (OR)|2.051||||0.001|TWO_SIDED|95.0|1.329|3.186||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 9||3.186|1.329|0.001
72506457|NCT04003155|144544762|SUPERIORITY||Odds Ratio (OR)|2.701|||<|0.001|TWO_SIDED|95.0|1.75|4.204||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 9||4.204|1.750|<0.001
72506458|NCT04003155|144544762|SUPERIORITY||Odds Ratio (OR)|2.725|||<|0.001|TWO_SIDED|95.0|1.742|4.306||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 10||4.306|1.742|<0.001
72506459|NCT04003155|144544762|SUPERIORITY||Odds Ratio (OR)|3.921|||<|0.001|TWO_SIDED|95.0|2.505|6.214||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 10||6.214|2.505|<0.001
72397696|NCT02801942|144301721|OTHER||Mean Difference (Final Values)|-1.78|STANDARD_ERROR_OF_MEAN|1.755|||TWO_SIDED|95.0|-5.54|1.98|||||The mean difference in Double Negative B Lymphocytes (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||1.98|-5.54|
72397697|NCT02801942|144301721|OTHER||Mean Difference (Final Values)|-8.3|STANDARD_ERROR_OF_MEAN|6.08|||TWO_SIDED|95.0|-21.58|4.98|||||The mean difference in Naive B Lymphocytes (Healthy participants versus NOT1D participants) by FNA method has been presented.|||4.98|-21.58|
72397698|NCT02801942|144301721|OTHER||Mean Difference (Final Values)|-8.31|STANDARD_ERROR_OF_MEAN|6.019|||TWO_SIDED|95.0|-21.49|4.87|||||The mean difference in Naive B Lymphocytes by (Healthy participants versus NOT1D participants) core biopsy method has been presented.|||4.87|-21.49|
72506460|NCT04003155|144544762|SUPERIORITY||Odds Ratio (OR)|2.104|||<|0.001|TWO_SIDED|95.0|1.363|3.27||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 11||3.270|1.363|<0.001
72506461|NCT04003155|144544762|SUPERIORITY||Odds Ratio (OR)|2.953|||<|0.001|TWO_SIDED|95.0|1.912|4.602||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 11||4.602|1.912|<0.001
72506462|NCT04003155|144544762|SUPERIORITY||Odds Ratio (OR)|1.894||||0.005|TWO_SIDED|95.0|1.22|2.961||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 12||2.961|1.220|0.005
72506463|NCT04003155|144544762|SUPERIORITY||Odds Ratio (OR)|3.156|||<|0.001|TWO_SIDED|95.0|2.035|4.944||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 12||4.944|2.035|<0.001
72506464|NCT04003155|144544763|SUPERIORITY||Odds Ratio (OR)|3.158||||0.322|TWO_SIDED|95.0|0.398|64.304||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 2||64.304|0.398|0.322
72506465|NCT04003155|144544763|SUPERIORITY||Odds Ratio (OR)|3.925||||0.225|TWO_SIDED|95.0|0.569|77.353||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 2||77.353|0.569|0.225
72397699|NCT02801942|144301722|OTHER||Mean Difference (Final Values)|4.97|STANDARD_ERROR_OF_MEAN|2.538|||TWO_SIDED|95.0|-0.54|10.48|||||The mean difference in B-cells (Healthy participants versus NOT1D participants) by FNA method has been presented.|||10.48|-0.54|
72397700|NCT02801942|144301722|OTHER||Mean Difference (Final Values)|-1.88|STANDARD_ERROR_OF_MEAN|2.99|||TWO_SIDED|95.0|-8.37|4.61|||||The mean difference in B-cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||4.61|-8.37|
72397701|NCT02801942|144301722|OTHER||Mean Difference (Final Values)|0.14|STANDARD_ERROR_OF_MEAN|0.189|||TWO_SIDED|95.0|-0.26|0.54|||||The mean difference in CD56bright NK cells (Healthy participants versus NOT1D participants) by FNA method has been presented.|||0.54|-0.26|
72397702|NCT02801942|144301722|OTHER||Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.147|||TWO_SIDED|95.0|-0.37|0.27|||||The mean difference in CD56bright NK cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||0.27|-0.37|
72397703|NCT02801942|144301722|OTHER||Mean Difference (Final Values)|-0.39|STANDARD_ERROR_OF_MEAN|0.402|||TWO_SIDED|95.0|-1.27|0.49|||||The mean difference in CD56lo CD16+ (Healthy participants versus NOT1D participants) by FNA method has been presented.|||0.49|-1.27|
72397704|NCT02801942|144301722|OTHER||Mean Difference (Final Values)|0.37|STANDARD_ERROR_OF_MEAN|0.312|||TWO_SIDED|95.0|-0.33|1.07|||||The mean difference in CD56lo CD16+ (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||1.07|-0.33|
72397705|NCT02801942|144301722|OTHER||Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.068|||TWO_SIDED|95.0|-0.16|0.13|||||The mean difference in CD56lo CD16- by (Healthy participants versus NOT1D participants) FNA method has been presented.|||0.13|-0.16|
72397706|NCT02801942|144301722|OTHER||Mean Difference (Final Values)|-0.03|STANDARD_ERROR_OF_MEAN|0.068|||TWO_SIDED|95.0|-0.17|0.12|||||The mean difference in CD56lo CD16- (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||0.12|-0.17|
72397707|NCT02801942|144301722|OTHER||Mean Difference (Final Values)|0.22|STANDARD_ERROR_OF_MEAN|0.114|||TWO_SIDED|95.0|-0.03|0.47|||||The mean difference in Dendritic cells (Healthy participants versus NOT1D participants) by FNA method has been presented.|||0.47|-0.03|
72397708|NCT02801942|144301722|OTHER||Mean Difference (Final Values)|-0.09|STANDARD_ERROR_OF_MEAN|0.221|||TWO_SIDED|95.0|-0.59|0.4|||||The mean difference in Dendritic cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||0.40|-0.59|
72506466|NCT04003155|144544763|SUPERIORITY||Odds Ratio (OR)|6.334||||0.089|TWO_SIDED|95.0|1.064|120.422||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 3||120.422|1.064|0.089
72506467|NCT04003155|144544763|SUPERIORITY||Odds Ratio (OR)|5.026||||0.143|TWO_SIDED|95.0|0.797|96.916||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 3||96.916|0.797|0.143
72506468|NCT04003155|144544763|SUPERIORITY||Odds Ratio (OR)|1.257||||0.711|TWO_SIDED|95.0|0.37|4.468||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 4||4.468|0.370|0.711
72506469|NCT04003155|144544763|SUPERIORITY||Odds Ratio (OR)|1.57||||0.441|TWO_SIDED|95.0|0.508|5.328||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 4||5.328|0.508|0.441
72506470|NCT04003155|144544763|SUPERIORITY||Odds Ratio (OR)|5.351||||0.032|TWO_SIDED|95.0|1.383|35.172||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 5||35.172|1.383|0.032
72622991|NCT03464461|144776285|OTHER|non-parametric||||||0.074|||||||Kruskal-Wallis|||||||0.0740
72622992|NCT03464461|144776286|OTHER|non-parametric||||||0.0984|||||||Kruskal-Wallis|||||||0.0984
72397709|NCT02801942|144301722|OTHER||Mean Difference (Final Values)|-0.06|STANDARD_ERROR_OF_MEAN|0.766|||TWO_SIDED|95.0|-1.72|1.6|||||The mean difference in NK cells (Healthy participants versus NOT1D participants) by FNA method has been presented.|||1.60|-1.72|
72397710|NCT02801942|144301722|OTHER||Mean Difference (Final Values)|-0.08|STANDARD_ERROR_OF_MEAN|0.417|||TWO_SIDED|95.0|-0.99|0.82|||||The mean difference in NK cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||0.82|-0.99|
72397711|NCT02801942|144301723|OTHER||Mean Difference (Final Values)|13.72|STANDARD_ERROR_OF_MEAN|7.475|||TWO_SIDED|95.0|-2.72|30.15|||||The mean difference in CD56bright NK cells (Healthy participants versus NOT1D participants) by FNA method has been presented.|||30.15|-2.72|
72397712|NCT02801942|144301723|OTHER||Mean Difference (Final Values)|-0.04|STANDARD_ERROR_OF_MEAN|7.566|||TWO_SIDED|95.0|-16.85|16.78|||||The mean difference in CD56bright NK cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||16.78|-16.85|
72397713|NCT02801942|144301723|OTHER||Mean Difference (Final Values)|-20.03|STANDARD_ERROR_OF_MEAN|8.586|||TWO_SIDED|95.0|-38.98|-1.08|||||The mean difference in CD56lo CD16+ (Healthy participants versus NOT1D participants) by FNA method has been presented.|||-1.08|-38.98|
72397714|NCT02801942|144301723|OTHER||Mean Difference (Final Values)|4.25|STANDARD_ERROR_OF_MEAN|12.739|||TWO_SIDED|95.0|-24.14|32.65|||||The mean difference in CD56lo CD16+ by (Healthy participants versus NOT1D participants) core biopsy method has been presented.|||32.65|-24.14|
72397715|NCT02801942|144301723|OTHER||Mean Difference (Final Values)|-0.14|STANDARD_ERROR_OF_MEAN|2.429|||TWO_SIDED|95.0|-5.54|5.26|||||The mean difference in CD56lo CD16- (Healthy participants versus NOT1D participants) by FNA method has been presented.|||5.26|-5.54|
72397716|NCT02801942|144301723|OTHER||Mean Difference (Final Values)|-2.79|STANDARD_ERROR_OF_MEAN|4.148|||TWO_SIDED|95.0|-12.31|6.73|||||The mean difference in CD56lo CD16- (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||6.73|-12.31|
72397717|NCT02801942|144301724|OTHER||Mean Difference (Final Values)|8.25|STANDARD_ERROR_OF_MEAN|7.673|||TWO_SIDED|95.0|-8.58|25.08|||||The mean difference in Myeloid Dendritic cells (Healthy participants versus NOT1D participants) by FNA method has been presented.|||25.08|-8.58|
72397718|NCT02801942|144301724|OTHER||Mean Difference (Final Values)|16.22|STANDARD_ERROR_OF_MEAN|6.189|||TWO_SIDED|95.0|3.17|29.26|||||The mean difference in Myeloid Dendritic cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||29.26|3.17|
72397719|NCT02801942|144301724|OTHER||Mean Difference (Final Values)|-7.89|STANDARD_ERROR_OF_MEAN|10.509|||TWO_SIDED|95.0|-31.03|15.25|||||The mean difference in Plasmacytoid Dendritic cells (Healthy participants versus NOT1D participants) by FNA method has been presented.|||15.25|-31.03|
72397720|NCT02801942|144301724|OTHER||Mean Difference (Final Values)|-13.85|STANDARD_ERROR_OF_MEAN|5.781|||TWO_SIDED|95.0|-26.04|-1.66|||||The mean difference in (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||-1.66|-26.04|
72397721|NCT02801942|144301726|OTHER||Mean Difference (Final Values)|-1.62|STANDARD_ERROR_OF_MEAN|3.561|||TWO_SIDED|95.0|-9.05|5.82|||||The mean difference in CD45RA+ Effector Memory CD8 cells (Healthy participants versus NOT1D participants) by FNA method has been presented.|||5.82|-9.05|
72397722|NCT02801942|144301726|OTHER||Mean Difference (Final Values)|4.01|STANDARD_ERROR_OF_MEAN|3.418|||TWO_SIDED|95.0|-3.13|11.16|||||The mean difference in CD45RA+ Effector Memory CD8 cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||11.16|-3.13|
72397723|NCT02801942|144301726|OTHER||Mean Difference (Final Values)|-0.16|STANDARD_ERROR_OF_MEAN|1.428|||TWO_SIDED|95.0|-3.14|2.82|||||The mean difference in Central Memory CD8 cells (Healthy participants versus NOT1D participants) by FNA method has been presented.|||2.82|-3.14|
72397724|NCT02801942|144301726|OTHER||Mean Difference (Final Values)|-1.16|STANDARD_ERROR_OF_MEAN|1.851|||TWO_SIDED|95.0|-5.03|2.71|||||The mean difference in Central Memory CD8 cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||2.71|-5.03|
72397725|NCT02801942|144301726|OTHER||Mean Difference (Final Values)|-2.11|STANDARD_ERROR_OF_MEAN|3.132|||TWO_SIDED|95.0|-8.65|4.43|||||The mean difference in Effector Memory CD8 cells (Healthy participants versus NOT1D participants) by FNA method has been presented.|||4.43|-8.65|
72397726|NCT02801942|144301726|OTHER||Mean Difference (Final Values)|-1.59|STANDARD_ERROR_OF_MEAN|3.071|||TWO_SIDED|95.0|-8.0|4.81|||||The mean difference in Effector Memory CD8 cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||4.81|-8.00|
72397727|NCT02801942|144301726|OTHER||Mean Difference (Final Values)|3.51|STANDARD_ERROR_OF_MEAN|6.594|||TWO_SIDED|95.0|-10.21|17.24|||||The mean difference in Naive CD8 cells (Healthy participants versus NOT1D participants) by FNA method has been presented.|||17.24|-10.21|
72397728|NCT02801942|144301726|OTHER||Mean Difference (Final Values)|-2.18|STANDARD_ERROR_OF_MEAN|7.155|||TWO_SIDED|95.0|-17.1|12.74|||||The mean difference in Naive CD8 cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||12.74|-17.10|
72472102|NCT02209181|144467338|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|4.71|STANDARD_ERROR_OF_MEAN|0.54|<|0.001|TWO_SIDED|95.0|3.64|5.78||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||5.78|3.64|<0.001
72472103|NCT02209181|144467338|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|1.36|STANDARD_ERROR_OF_MEAN|0.54||0.012|TWO_SIDED|95.0|0.3|2.42||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||2.42|0.30|0.012
72472104|NCT02209181|144467338|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|3.73|STANDARD_ERROR_OF_MEAN|0.54|<|0.001|TWO_SIDED|95.0|2.66|4.81||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||4.81|2.66|<0.001
72472105|NCT02209181|144467338|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-3.35|STANDARD_ERROR_OF_MEAN|0.54|<|0.001|TWO_SIDED|95.0|-4.41|-2.29||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||-2.29|-4.41|<0.001
72622993|NCT03685149|144776290|SUPERIORITY||percent reduction|72.0|||<|0.0001|TWO_SIDED|95.0|56.0|82.0|||Mixed Models Analysis|||||82|56|<0.0001
72397729|NCT02801942|144301726|OTHER||Mean Difference (Final Values)|-0.92|STANDARD_ERROR_OF_MEAN|0.708|||TWO_SIDED|95.0|-2.42|0.58|||||The mean difference in Stem Cell Memory-like CD8 cells (Healthy participants versus NOT1D participants) by FNA method has been presented.|||0.58|-2.42|
72397730|NCT02801942|144301726|OTHER||Mean Difference (Final Values)|-0.42|STANDARD_ERROR_OF_MEAN|0.372|||TWO_SIDED|95.0|-1.19|0.35|||||The mean difference in Stem Cell Memory-like CD8 cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||0.35|-1.19|
72506471|NCT04003155|144544763|SUPERIORITY||Odds Ratio (OR)|3.059||||0.175|TWO_SIDED|95.0|0.693|21.086||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 5||21.086|0.693|0.175
72506472|NCT04003155|144544763|SUPERIORITY||Odds Ratio (OR)|4.225||||0.071|TWO_SIDED|95.0|1.039|28.29||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 6||28.290|1.039|0.071
72506473|NCT04003155|144544763|SUPERIORITY||Odds Ratio (OR)|5.22||||0.035|TWO_SIDED|95.0|1.348|34.323||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 6||34.323|1.348|0.035
72506474|NCT04003155|144544763|SUPERIORITY||Odds Ratio (OR)|7.064||||0.011|TWO_SIDED|95.0|1.912|45.64||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 7||45.640|1.912|0.011
72506475|NCT04003155|144544763|SUPERIORITY||Odds Ratio (OR)|6.949||||0.012|TWO_SIDED|95.0|1.881|44.892||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 7||44.892|1.881|0.012
72506476|NCT04003155|144544763|SUPERIORITY||Odds Ratio (OR)|5.344||||0.032|TWO_SIDED|95.0|1.381|35.134||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 8||35.134|1.381|0.032
72506477|NCT04003155|144544763|SUPERIORITY||Odds Ratio (OR)|7.514||||0.008|TWO_SIDED|95.0|2.055|48.354||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 8||48.354|2.055|0.008
72506478|NCT04003155|144544763|SUPERIORITY||Odds Ratio (OR)|3.238||||0.026|TWO_SIDED|95.0|1.222|10.148||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 9||10.148|1.222|0.026
72506479|NCT04003155|144544763|SUPERIORITY||Odds Ratio (OR)|3.438||||0.019|TWO_SIDED|95.0|1.311|10.714||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 9||10.714|1.311|0.019
72506480|NCT04003155|144544763|SUPERIORITY||Odds Ratio (OR)|2.626||||0.037|TWO_SIDED|95.0|1.101|6.951||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 10||6.951|1.101|0.037
72506481|NCT04003155|144544763|SUPERIORITY||Odds Ratio (OR)|2.758||||0.027|TWO_SIDED|95.0|1.167|7.263||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 10||7.263|1.167|0.027
72506482|NCT04003155|144544763|SUPERIORITY||Odds Ratio (OR)|1.69||||0.21|TWO_SIDED|95.0|0.753|3.968||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 11||3.968|0.753|0.210
72506483|NCT04003155|144544763|SUPERIORITY||Odds Ratio (OR)|2.01||||0.087|TWO_SIDED|95.0|0.923|4.634||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 11||4.634|0.923|0.087
72506484|NCT04003155|144544763|SUPERIORITY||Odds Ratio (OR)|2.1||||0.148|TWO_SIDED|95.0|0.795|6.157||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 12||6.157|0.795|0.148
72506485|NCT04003155|144544763|SUPERIORITY||Odds Ratio (OR)|3.262||||0.015|TWO_SIDED|95.0|1.329|9.194||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 12||9.194|1.329|0.015
72506486|NCT03864237|144544820|SUPERIORITY||beta coefficient for condition|0.53|STANDARD_ERROR_OF_MEAN|0.93||0.568|TWO_SIDED|95.0|-1.31|2.37|||Regression, Linear|Regression controls for baseline value of outcome and sex to determine pre-post change in the outcome as a function of condition.||||2.37|-1.31|0.568
72506487|NCT03864237|144544821|SUPERIORITY||beta coefficient for condition|1.22|STANDARD_ERROR_OF_MEAN|0.69||0.077|TWO_SIDED|95.0|-0.13|2.59|||Regression, Linear|||||2.59|-0.13|0.077
72506488|NCT03864237|144544822|SUPERIORITY||beta coefficient for condition|-1.21|STANDARD_ERROR_OF_MEAN|1.17||0.3|TWO_SIDED|95.0|-3.52|1.11|||Regression, Linear|||||1.11|-3.52|0.30
72506489|NCT03864237|144544823|SUPERIORITY||beta coefficient for condition|0.84|STANDARD_ERROR_OF_MEAN|1.09||0.44|TWO_SIDED|95.0|-1.31|3.0|||Regression, Linear|||||3.0|-1.31|0.44
72506490|NCT03864237|144544824|SUPERIORITY||Beta coefficient for condition|-0.25|STANDARD_ERROR_OF_MEAN|1.29||0.845|TWO_SIDED|95.0|-2.81|2.3|||Regression, Linear|||||2.30|-2.81|0.845
72506491|NCT03864237|144544825|SUPERIORITY||Beta coefficient for condition|0.3|STANDARD_ERROR_OF_MEAN|1.01||0.77|TWO_SIDED|95.0|-1.72|2.31|||Regression, Linear|||||2.31|-1.72|0.77
72397731|NCT02801942|144301728|OTHER||Mean Difference (Final Values)|-5.39|STANDARD_ERROR_OF_MEAN|2.545|||TWO_SIDED|95.0|-11.56|0.78|||||The mean difference in PD-1+ ICOS+ TFH cells (Healthy participants versus NOT1D participants) by FNA method has been presented.|||0.78|-11.56|
72506492|NCT03864237|144544826|SUPERIORITY||Beta coefficient for condition|1.77|STANDARD_ERROR_OF_MEAN|1.4||0.21|TWO_SIDED|95.0|-1.0|4.54|||Regression, Linear|||||4.54|-1.0|0.21
72622994|NCT03685149|144776291|SUPERIORITY||Mean Difference (Final Values)|0.0||||1|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||1.00
72397732|NCT02801942|144301728|OTHER||Mean Difference (Final Values)|-7.03|STANDARD_ERROR_OF_MEAN|7.114|||TWO_SIDED|95.0|-22.22|8.16|||||The mean difference in PD-1+ ICOS+ TFH cells (Healthy participants versus NOT1D participants) by core biopsy FNA method has been presented.|||8.16|-22.22|
72472106|NCT02209181|144467338|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.98|STANDARD_ERROR_OF_MEAN|0.54||0.074|TWO_SIDED|95.0|-2.05|0.09||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.09|-2.05|0.074
72472107|NCT02209181|144467339|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|3.8|STANDARD_ERROR_OF_MEAN|0.59|<|0.001|TWO_SIDED|95.0|2.63|4.97||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||4.97|2.63|<0.001
72472108|NCT02209181|144467339|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|1.32|STANDARD_ERROR_OF_MEAN|0.59||0.026|TWO_SIDED|95.0|0.16|2.48||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||2.48|0.16|0.026
72472109|NCT02209181|144467339|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|3.82|STANDARD_ERROR_OF_MEAN|0.6|<|0.001|TWO_SIDED|95.0|2.64|4.99||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||4.99|2.64|<0.001
72472110|NCT02209181|144467339|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-2.48|STANDARD_ERROR_OF_MEAN|0.59|<|0.001|TWO_SIDED|95.0|-3.64|-1.32||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||-1.32|-3.64|<0.001
72472111|NCT02209181|144467339|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.02|STANDARD_ERROR_OF_MEAN|0.6||0.978|TWO_SIDED|95.0|-1.16|1.19||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.19|-1.16|0.978
72472112|NCT02209181|144467340|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|3.4|STANDARD_ERROR_OF_MEAN|0.62|<|0.001|TWO_SIDED|95.0|2.18|4.62||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||4.62|2.18|<0.001
72472113|NCT02209181|144467340|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|1.07|STANDARD_ERROR_OF_MEAN|0.61||0.081|TWO_SIDED|95.0|-0.13|2.28||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||2.28|-0.13|0.081
72472114|NCT02209181|144467340|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|3.91|STANDARD_ERROR_OF_MEAN|0.62|<|0.001|TWO_SIDED|95.0|2.69|5.14||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||5.14|2.69|<0.001
72506493|NCT02546856|144544827|NON_INFERIORITY|For the hypothesis that the relative dose of BBs would reach 52% by the end of the study and using an equivalence margin of 7%, we would need 157 patients per group for an alpha level of significance of 0.05 and a statistical power of 80% (beta of 0.80).|Mean Difference (Final Values)|14.8|||<|0.001|TWO_SIDED|95.0|7.5|22.1|||t-test, 2 sided|||||22.1|7.5|<0.001
72506494|NCT02546856|144544828|EQUIVALENCE|equivalence margin of 5%|Difference in percentages|1.4||||0.52|TWO_SIDED|95.0|-3.33|6.32|||Chi-squared|||||6.32|-3.33|0.52
72506495|NCT02546856|144544829|NON_INFERIORITY|Equivalence margin of 5%|Difference in percentages|2.1||||0.31|TWO_SIDED|95.0|-1.9|6.1|||Chi-squared|||||6.1|-1.9|0.31
72397733|NCT02801942|144301729|OTHER||Mean Difference (Final Values)|0.39|STANDARD_ERROR_OF_MEAN|0.358|||TWO_SIDED|95.0|-0.36|1.14|||||The mean difference in CD45RA+ Effector Memory Conv T cells (Healthy participants versus NOT1D participants) by FNA method has been presented.|||1.14|-0.36|
72472115|NCT02209181|144467340|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-2.32|STANDARD_ERROR_OF_MEAN|0.61|<|0.001|TWO_SIDED|95.0|-3.53|-1.11||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||-1.11|-3.53|<0.001
72472116|NCT02209181|144467340|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.52|STANDARD_ERROR_OF_MEAN|0.62||0.407|TWO_SIDED|95.0|-0.71|1.74||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.74|-0.71|0.407
72506496|NCT02546856|144544830|NON_INFERIORITY|Equivalence margin of 5%|Difference in percentages|-0.63||||0.85|TWO_SIDED|95.0|-7.1|5.85|||Chi-squared|||||5.85|-7.1|0.85
72506497|NCT02546856|144544831|NON_INFERIORITY|Equivalence margin of 5%|Difference in percentages|2.12||||0.44|TWO_SIDED|95.0|-3.3|7.54|||Chi-squared|||||7.54|-3.3|0.44
72506498|NCT02546856|144544833|NON_INFERIORITY|equivalence margin of 5%|Difference in percentages|0.7||||0.56|TWO_SIDED|95.0|-1.6|3.04|||Chi-squared|||||3.04|-1.6|0.56
72506499|NCT02546856|144544837|NON_INFERIORITY|Equivalence margin of 5%|Mean Difference (Final Values)|0.07||||0.96|TWO_SIDED|95.0|-2.69|2.83|||t-test, 2 sided|||||2.83|-2.69|0.96
72506500|NCT02546856|144544838|NON_INFERIORITY|Equivalence margin of 5%|Mean Difference (Final Values)|16.47||||0.97|TWO_SIDED|95.0|-781.0|748.0|||t-test, 2 sided|||||748|-781|0.97
72506501|NCT02546856|144544839|NON_INFERIORITY|Equivalence margin of 5%|Mean Difference (Final Values)|7.28||||0.44|TWO_SIDED|95.0|-11.27|25.83|||t-test, 2 sided|||||25.83|-11.27|0.44
72506502|NCT02546856|144544841|NON_INFERIORITY|Equivalence margin of 5%|Mean Difference (Final Values)|-0.91||||0.75|TWO_SIDED|95.0|-6.63|4.81|||t-test, 2 sided|||||4.81|-6.63|0.75
72506503|NCT02546856|144544842|NON_INFERIORITY|Equivalence margin of 5%|Mean Difference (Final Values)|0.04||||0.2|TWO_SIDED|95.0|-0.2|0.28|||t-test, 2 sided|||||0.28|-0.2|0.20
72506504|NCT02546856|144544843|EQUIVALENCE|equivalence margin of 5%|Difference in percentages|-5.5||||0.01|TWO_SIDED|95.0|-9.7|-1.4|||Chi-squared|||||-1.4|-9.7|0.01
72472117|NCT02209181|144467341|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|2.83|STANDARD_ERROR_OF_MEAN|0.64|<|0.001|TWO_SIDED|95.0|1.56|4.1||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||4.10|1.56|<0.001
72472118|NCT02209181|144467341|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.88|STANDARD_ERROR_OF_MEAN|0.64||0.17|TWO_SIDED|95.0|-0.38|2.14||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||2.14|-0.38|0.170
72472119|NCT02209181|144467341|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|3.6|STANDARD_ERROR_OF_MEAN|0.65|<|0.001|TWO_SIDED|95.0|2.33|4.87||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||4.87|2.33|<0.001
72472120|NCT02209181|144467341|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-1.95|STANDARD_ERROR_OF_MEAN|0.64||0.002|TWO_SIDED|95.0|-3.21|-0.69||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||-0.69|-3.21|0.002
72506505|NCT02546856|144544844|NON_INFERIORITY|Equivalence margin of 5%|Difference in percentages|-0.68||||0.71|TWO_SIDED|95.0|-4.2|2.87|||Chi-squared|Equivalence margin of 7%||||2.87|-4.2|0.71
72506506|NCT02546856|144544845|NON_INFERIORITY|Equivalence margin of 7%|Mean Difference (Final Values)|16.5|||<|0.001|TWO_SIDED|95.0|8.7|24.3|||t-test, 2 sided|||||24.3|8.7|<0.001
72506507|NCT02546856|144544846|NON_INFERIORITY|Equivalence margin of 7%|Mean Difference (Final Values)|0.9||||0.93|TWO_SIDED|95.0|-15.1|17.1|||t-test, 2 sided|||||17.1|-15.1|0.93
72506508|NCT02546856|144544847|NON_INFERIORITY|Equivalence margin of 7%|Mean Difference (Final Values)|0.5||||0.86|TWO_SIDED|95.0|-7.1|8.2|||t-test, 2 sided|||||8.2|-7.1|0.86
72506509|NCT01097616|144544851|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|19.6|||<|1e-05|TWO_SIDED|95.0|12.0|27.1||By multiplicity strategy above, overall Type I error among primary hypotheses was controlled at two-sided 5% significance level.|Longitudinal Data Analysis|Model terms: baseline value, age group, region, gender, treatment, time, and time by treatment interaction.||The null hypothesis, that suvorexant HD did not differ from placebo for Month 1 sTSTm, had planned marginal power of 97.6%. Sleep maintenance (sTSTm, WASO) and sleep onset (sTSOm, LPS) endpoints were tested at two-sided 2.5% significance level. Both Month 1 endpoints for sleep maintenance must be significant to test Month 3 endpoints; the same approach was used for sleep onset endpoints.||27.1|12.0|<0.00001
72506510|NCT01097616|144544852|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|19.7|||<|1e-05|TWO_SIDED|95.0|11.9|27.6||By multiplicity strategy above, overall Type I error among primary hypotheses was controlled at two-sided 5% significance level.|Longitudinal Data Analysis|Model terms: baseline value, age group, region, gender, treatment, time, and time by treatment interaction.||The null hypothesis, that suvorexant HD did not differ from placebo for Month 3 sTSTm, had planned marginal power of 95.7%. Sleep maintenance (sTSTm, WASO) and sleep onset (sTSOm, LPS) endpoints were tested at two-sided 2.5% significance level. Both Month 1 endpoints for sleep maintenance must be significant to test Month 3 endpoints; the same approach was used for sleep onset endpoints.||27.6|11.9|<0.00001
72622995|NCT03685149|144776292|SUPERIORITY|||||||0.009|||||||Wilcoxon (Mann-Whitney)|||||||0.009
72472121|NCT02209181|144467341|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.77|STANDARD_ERROR_OF_MEAN|0.65||0.235|TWO_SIDED|95.0|-0.5|2.04||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||2.04|-0.50|0.235
72472122|NCT02209181|144467342|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|2.1|STANDARD_ERROR_OF_MEAN|0.65||0.001|TWO_SIDED|95.0|0.82|3.39||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||3.39|0.82|0.001
72472123|NCT02209181|144467342|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.6|STANDARD_ERROR_OF_MEAN|0.65||0.355|TWO_SIDED|95.0|-0.68|1.87||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.87|-0.68|0.355
72506511|NCT01097616|144544853|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-26.3|||<|1e-05|TWO_SIDED|95.0|-33.5|-19.2||By multiplicity strategy above, overall Type I error among primary hypotheses was controlled at two-sided 5% significance level.|Longitudinal Data Analysis|Model terms: baseline value, age group, region, gender, treatment, time, and time by treatment interaction.||The null hypothesis, that suvorexant HD did not differ from placebo for Month 1 WASO, had planned marginal power of 99.2%. Sleep maintenance (sTSTm, WASO) and sleep onset (sTSOm, LPS) endpoints were tested at two-sided 2.5% significance level. Both Month 1 endpoints for sleep maintenance must be significant to test Month 3 endpoints; the same approach was used for sleep onset endpoints.||-19.2|-33.5|<0.00001
72506512|NCT01097616|144544854|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-22.9|||<|1e-05|TWO_SIDED|95.0|-30.3|-15.4||By multiplicity strategy above, overall Type I error among primary hypotheses was controlled at two-sided 5% significance level.|Longitudinal Data Analysis|Model terms: baseline value, age group, region, gender, treatment, time, and time by treatment interaction.||The null hypothesis, that suvorexant HD did not differ from placebo for Month 3 WASO, had planned marginal power of 98.3%. Sleep maintenance (sTSTm, WASO) and sleep onset (sTSOm, LPS) endpoints were tested at two-sided 2.5% significance level. Both Month 1 endpoints for sleep maintenance must be significant to test Month 3 endpoints; the same approach was used for sleep onset endpoints.||-15.4|-30.3|<0.00001
72622996|NCT03685149|144776293|SUPERIORITY|||||||0.207|||||||Wilcoxon (Mann-Whitney)|||||||0.207
72622997|NCT00209131|144776306|NON_INFERIORITY_OR_EQUIVALENCE||||||<|0.05||95.0|||||Other|||No analysis was conducted.||||<0.05
72622998|NCT04918771|144776365|SUPERIORITY||Mean Difference (Final Values)|1.09||||0.0003|TWO_SIDED|95.0|0.51|1.67|||t-test, 2 sided|||Mean time to resolution of ARVI symptoms||1.67|0.51|0.0003
72397734|NCT02801942|144301729|OTHER||Mean Difference (Final Values)|0.13|STANDARD_ERROR_OF_MEAN|0.184|||TWO_SIDED|95.0|-0.25|0.52|||||The mean difference in CD45RA+ Effector Memory Conv T cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||0.52|-0.25|
72565782|NCT02709486|144662700|SUPERIORITY||Least Square Mean Difference|-0.77|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-1.04|-0.49|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC average scores and baseline diary average pain as covariates, and study site as a random effect.||-0.49|-1.04|<.0001
72565783|NCT02709486|144662700|SUPERIORITY||Least Square Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-1.08|-0.53|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC average scores and baseline diary average pain as covariates, and study site as a random effect.||-0.53|-1.08|<.0001
72565784|NCT02709486|144662700|SUPERIORITY||Least Square Mean Difference|-0.61|STANDARD_ERROR_OF_MEAN|0.15|<|0.0001|TWO_SIDED|95.0|-0.9|-0.32|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC average scores and baseline diary average pain as covariates, and study site as a random effect.||-0.32|-0.90|<.0001
72565785|NCT02709486|144662700|SUPERIORITY||Least Square Mean Difference|-0.84|STANDARD_ERROR_OF_MEAN|0.15|<|0.0001|TWO_SIDED|95.0|-1.13|-0.56|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC average scores and baseline diary average pain as covariates, and study site as a random effect.||-0.56|-1.13|<.0001
72565786|NCT02709486|144662700|SUPERIORITY||Least Square Mean Difference|-0.78|STANDARD_ERROR_OF_MEAN|0.16|<|0.0001|TWO_SIDED|95.0|-1.09|-0.47|||ANCOVA|||Week 12: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC average scores and baseline diary average pain as covariates, and study site as a random effect.||-0.47|-1.09|<.0001
72565787|NCT02709486|144662700|SUPERIORITY||Least Square Mean Difference|-0.81|STANDARD_ERROR_OF_MEAN|0.16|<|0.0001|TWO_SIDED|95.0|-1.12|-0.5|||ANCOVA|||Week 12: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC average scores and baseline diary average pain as covariates, and study site as a random effect.||-0.50|-1.12|<.0001
72565788|NCT02709486|144662700|SUPERIORITY||Least Square Mean Difference|-0.63|STANDARD_ERROR_OF_MEAN|0.16||0.0001|TWO_SIDED|95.0|-0.95|-0.35|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC average scores and baseline diary average pain as covariates, and study site as a random effect.||-0.35|-0.95|0.0001
72565789|NCT02709486|144662700|SUPERIORITY||Least Square Mean Difference|-0.67|STANDARD_ERROR_OF_MEAN|0.16|<|0.0001|TWO_SIDED|95.0|-0.99|-0.35|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC average scores and baseline diary average pain as covariates, and study site as a random effect.||-0.35|-0.99|<.0001
72565790|NCT02709486|144662700|SUPERIORITY||Least Square Mean Difference|-0.55|STANDARD_ERROR_OF_MEAN|0.17||0.0015|TWO_SIDED|95.0|-0.89|-0.21|||ANCOVA|||Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC average scores and baseline diary average pain as covariates, and study site as a random effect.||-0.21|-0.89|0.0015
72565791|NCT02709486|144662700|SUPERIORITY||Least Square Mean Difference|-0.73|STANDARD_ERROR_OF_MEAN|0.17|<|0.0001|TWO_SIDED|95.0|-1.07|-0.39|||ANCOVA|||Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC average scores and baseline diary average pain as covariates, and study site as a random effect.||-0.39|-1.07|<.0001
72565792|NCT02709486|144662702|SUPERIORITY||Least Square Mean Difference|-0.67|STANDARD_ERROR_OF_MEAN|0.15|<|0.0001|TWO_SIDED|95.0|-0.96|-0.38|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.||-0.38|-0.96|<.0001
72565793|NCT02709486|144662702|SUPERIORITY||Least Square Mean Difference|-0.37|STANDARD_ERROR_OF_MEAN|0.15||0.0139|TWO_SIDED|95.0|-0.67|-0.08|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.||-0.08|-0.67|0.0139
72622999|NCT04918771|144776366|SUPERIORITY||Mean Difference (Final Values)|2.35||||0.3274|TWO_SIDED|95.0|-2.36|7.06|||t-test, 2 sided|||Mean AUC score for severity of ARVI (Clinically Diagnosed and/or PCR-confirmed).||7.06|-2.36|0.3274
72397735|NCT02801942|144301729|OTHER||Mean Difference (Final Values)|-0.19|STANDARD_ERROR_OF_MEAN|4.22|||TWO_SIDED|95.0|-9.02|8.64|||||The mean difference in Central Memory Conv T cells (Healthy participants versus NOT1D participants) by FNA method has been presented.|||8.64|-9.02|
72472124|NCT02209181|144467342|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|3.36|STANDARD_ERROR_OF_MEAN|0.65|<|0.001|TWO_SIDED|95.0|2.07|4.65||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||4.65|2.07|<0.001
72472125|NCT02209181|144467342|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-1.5|STANDARD_ERROR_OF_MEAN|0.65||0.021|TWO_SIDED|95.0|-2.78|-0.23||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||-0.23|-2.78|0.021
72472126|NCT02209181|144467342|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|1.26|STANDARD_ERROR_OF_MEAN|0.65||0.056|TWO_SIDED|95.0|-0.03|2.55||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||2.55|-0.03|0.056
72472127|NCT02209181|144467343|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|1.21|STANDARD_ERROR_OF_MEAN|0.66||0.067|TWO_SIDED|95.0|-0.09|2.5||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||2.50|-0.09|0.067
72472128|NCT02209181|144467343|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.39|STANDARD_ERROR_OF_MEAN|0.65||0.547|TWO_SIDED|95.0|-0.89|1.68||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.68|-0.89|0.547
72472129|NCT02209181|144467343|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|3.16|STANDARD_ERROR_OF_MEAN|0.66|<|0.001|TWO_SIDED|95.0|1.86|4.46||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||4.46|1.86|<0.001
72472130|NCT02209181|144467343|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.81|STANDARD_ERROR_OF_MEAN|0.65||0.214|TWO_SIDED|95.0|-2.1|0.47||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.47|-2.10|0.214
72472131|NCT02209181|144467343|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|1.96|STANDARD_ERROR_OF_MEAN|0.66||0.003|TWO_SIDED|95.0|0.66|3.26||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||3.26|0.66|0.003
72472132|NCT02209181|144467344|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.69|STANDARD_ERROR_OF_MEAN|0.64||0.281|TWO_SIDED|95.0|-0.57|1.95||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.95|-0.57|0.281
72472133|NCT02209181|144467344|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.22|STANDARD_ERROR_OF_MEAN|0.63||0.729|TWO_SIDED|95.0|-1.03|1.47||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.47|-1.03|0.729
72472134|NCT02209181|144467344|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|3.21|STANDARD_ERROR_OF_MEAN|0.64|<|0.001|TWO_SIDED|95.0|1.95|4.47||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||4.47|1.95|<0.001
72472135|NCT02209181|144467344|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.47|STANDARD_ERROR_OF_MEAN|0.63||0.459|TWO_SIDED|95.0|-1.72|0.78||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.78|-1.72|0.459
72472136|NCT02209181|144467344|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|2.52|STANDARD_ERROR_OF_MEAN|0.64|<|0.001|TWO_SIDED|95.0|1.26|3.78||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||3.78|1.26|<0.001
72472137|NCT02209181|144467345|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.27|STANDARD_ERROR_OF_MEAN|0.65||0.674|TWO_SIDED|95.0|-1.0|1.55||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.55|-1.00|0.674
72472138|NCT02209181|144467345|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.52|STANDARD_ERROR_OF_MEAN|0.64||0.417|TWO_SIDED|95.0|-0.74|1.79||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.79|-0.74|0.417
72472139|NCT02209181|144467345|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|3.05|STANDARD_ERROR_OF_MEAN|0.65|<|0.001|TWO_SIDED|95.0|1.77|4.33||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||4.33|1.77|<0.001
72472140|NCT02209181|144467345|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.25|STANDARD_ERROR_OF_MEAN|0.64||0.698|TWO_SIDED|95.0|-1.02|1.52||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.52|-1.02|0.698
72623000|NCT04918771|144776366|SUPERIORITY||Mean Difference (Final Values)|5.3||||0.1171|TWO_SIDED|95.0|-1.34|11.93|||t-test, 2 sided|||Mean AUC score for severity of ARVI (PCR-confirmed).||11.93|-1.34|0.1171
72623001|NCT04918771|144776367|SUPERIORITY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
72623002|NCT04918771|144776368|SUPERIORITY||Mean Difference (Final Values)|0.58||||0.0073|TWO_SIDED|95.0|0.16|1.0|||t-test, 2 sided|||The mean time to Resolution of ARVI Symptoms was analysed.||1.00|0.16|0.0073
72397736|NCT02801942|144301729|OTHER||Mean Difference (Final Values)|-3.72|STANDARD_ERROR_OF_MEAN|4.223|||TWO_SIDED|95.0|-12.57|5.13|||||The mean difference in Central Memory Conv T cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||5.13|-12.57|
72397737|NCT02801942|144301729|OTHER||Mean Difference (Final Values)|2.25|STANDARD_ERROR_OF_MEAN|4.034|||TWO_SIDED|95.0|-6.16|10.66|||||The mean difference in Effector Memory Conv T cells (Healthy participants versus NOT1D participants) by FNA method has been presented.|||10.66|-6.16|
72397738|NCT02801942|144301729|OTHER||Mean Difference (Final Values)|2.06|STANDARD_ERROR_OF_MEAN|3.994|||TWO_SIDED|95.0|-6.27|10.39|||||The mean difference in Effector Memory Conv T cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||10.39|-6.27|
72397739|NCT02801942|144301729|OTHER||Mean Difference (Final Values)|-2.09|STANDARD_ERROR_OF_MEAN|5.727|||TWO_SIDED|95.0|-14.09|9.92|||||The mean difference in Naive Conv T cells (Healthy participants versus NOT1D participants) by FNA method has been presented.|||9.92|-14.09|
72397740|NCT02801942|144301729|OTHER||Mean Difference (Final Values)|0.48|STANDARD_ERROR_OF_MEAN|4.976|||TWO_SIDED|95.0|-9.91|10.87|||||The mean difference in Naive Conv T cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||10.87|-9.91|
72472141|NCT02209181|144467345|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|2.77|STANDARD_ERROR_OF_MEAN|0.65|<|0.001|TWO_SIDED|95.0|1.49|4.05||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||4.05|1.49|<0.001
72565794|NCT02709486|144662702|SUPERIORITY||Least Square Mean Difference|-0.82|STANDARD_ERROR_OF_MEAN|0.16|<|0.0001|TWO_SIDED|95.0|-1.13|-0.51|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.||-0.51|-1.13|<.0001
72397741|NCT02801942|144301729|OTHER||Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.314|||TWO_SIDED|95.0|-0.67|0.65|||||The mean difference in Stem Cell Memory-like Conv T cells (Healthy participants versus NOT1D participants) by FNA method has been presented.|||0.65|-0.67|
72397742|NCT02801942|144301729|OTHER||Mean Difference (Final Values)|-0.42|STANDARD_ERROR_OF_MEAN|0.325|||TWO_SIDED|95.0|-1.1|0.26|||||The mean difference in Stem Cell Memory-like Conv T cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||0.26|-1.10|
72397743|NCT02801942|144301730|OTHER||Mean Difference (Final Values)|7.0|STANDARD_ERROR_OF_MEAN|4.671|||TWO_SIDED|95.0|-2.8|16.81|||||The mean difference in TFH cells (Healthy participants versus NOT1D participants) by FNA method has been presented.|||16.81|-2.80|
72397744|NCT02801942|144301730|OTHER||Mean Difference (Final Values)|-3.93|STANDARD_ERROR_OF_MEAN|4.828|||TWO_SIDED|95.0|-14.02|6.17|||||The mean difference in TFH cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||6.17|-14.02|
72397745|NCT02801942|144301730|OTHER||Mean Difference (Final Values)|-1.26|STANDARD_ERROR_OF_MEAN|0.651|||TWO_SIDED|95.0|-2.69|0.16|||||The mean difference in PD-1+ ICOS+ TFH cells (Healthy participants versus NOT1D participants) by FNA method has been presented.|||0.16|-2.69|
72397746|NCT02801942|144301730|OTHER||Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|1.507|||TWO_SIDED|95.0|-3.21|3.24|||||The mean difference in PD-1+ ICOS+ TFH cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||3.24|-3.21|
72397747|NCT02801942|144301730|OTHER||Mean Difference (Final Values)|0.77|STANDARD_ERROR_OF_MEAN|1.709|||TWO_SIDED|95.0|-2.78|4.33|||||The mean difference in TH17 cells (Healthy participants versus NOT1D participants) by FNA method has been presented.|||4.33|-2.78|
72397748|NCT02801942|144301730|OTHER||Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|1.339|||TWO_SIDED|95.0|-2.75|2.85|||||The mean difference in TH17 cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||2.85|-2.75|
72397749|NCT02801942|144301730|OTHER||Mean Difference (Final Values)|-0.97|STANDARD_ERROR_OF_MEAN|3.631|||TWO_SIDED|95.0|-8.56|6.63|||||The mean difference in TH1 cells (Healthy participants versus NOT1D participants) by FNA method has been presented.|||6.63|-8.56|
72397750|NCT02801942|144301730|OTHER||Mean Difference (Final Values)|-6.03|STANDARD_ERROR_OF_MEAN|2.708|||TWO_SIDED|95.0|-11.69|-0.38|||||The mean difference in TH1 cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||-0.38|-11.69|
72397751|NCT02801942|144301730|OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.889|||TWO_SIDED|95.0|-1.98|1.78|||||The mean difference in TH1 TH17 cells (Healthy participants versus NOT1D participants) by FNA method has been presented.|||1.78|-1.98|
72397752|NCT02801942|144301730|OTHER||Mean Difference (Final Values)|0.59|STANDARD_ERROR_OF_MEAN|0.787|||TWO_SIDED|95.0|-1.07|2.24|||||The mean difference in TH1 TH17 cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||2.24|-1.07|
72397753|NCT02801942|144301730|OTHER||Mean Difference (Final Values)|0.43|STANDARD_ERROR_OF_MEAN|0.613|||TWO_SIDED|95.0|-0.85|1.72|||||The mean difference in TH1 TH17 TH2 T cells (Healthy participants versus NOT1D participants) by FNA method has been presented.|||1.72|-0.85|
72397754|NCT02801942|144301730|OTHER||Mean Difference (Final Values)|0.38|STANDARD_ERROR_OF_MEAN|0.565|||TWO_SIDED|95.0|-0.8|1.56|||||The mean difference in TH1 TH17 TH2 T cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||1.56|-0.80|
72397755|NCT02801942|144301730|OTHER||Mean Difference (Final Values)|0.53|STANDARD_ERROR_OF_MEAN|1.546|||TWO_SIDED|95.0|-2.71|3.76|||||The mean difference in TH1 TH2 cells (Healthy participants versus NOT1D participants) by FNA method has been presented.|||3.76|-2.71|
72397756|NCT02801942|144301730|OTHER||Mean Difference (Final Values)|0.42|STANDARD_ERROR_OF_MEAN|1.61|||TWO_SIDED|95.0|-2.95|3.79|||||The mean difference in TH1 TH2 cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||3.79|-2.95|
72623003|NCT04918771|144776369|SUPERIORITY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
72623004|NCT04918771|144776370|SUPERIORITY|||||||0.3627|||||||Wilcoxon (Mann-Whitney)|||Dosing Frequency of Antipyretics. Comparison for Day 1.||||0.3627
72623005|NCT04918771|144776370|SUPERIORITY|||||||0.5578|||||||Wilcoxon (Mann-Whitney)|||Dosing Frequency of Antipyretics. Comparison for Day 2.||||0.5578
72623006|NCT04918771|144776370|SUPERIORITY|||||||0.7688|||||||Wilcoxon (Mann-Whitney)|||Dosing Frequency of Antipyretics. Comparison for Day 3.||||0.7688
72397757|NCT02801942|144301730|OTHER||Mean Difference (Final Values)|2.15|STANDARD_ERROR_OF_MEAN|3.356|||TWO_SIDED|95.0|-4.84|9.14|||||The mean difference in TH2 cells (Healthy participants versus NOT1D participants) by FNA method has been presented.|||9.14|-4.84|
72472142|NCT02209181|144467346|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.39|STANDARD_ERROR_OF_MEAN|0.64||0.541|TWO_SIDED|95.0|-0.87|1.66||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.66|-0.87|0.541
72472143|NCT02209181|144467346|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.53|STANDARD_ERROR_OF_MEAN|0.64||0.409|TWO_SIDED|95.0|-0.73|1.79||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.79|-0.73|0.409
72472144|NCT02209181|144467346|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|3.12|STANDARD_ERROR_OF_MEAN|0.65|<|0.001|TWO_SIDED|95.0|1.85|4.39||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||4.39|1.85|<0.001
72472145|NCT02209181|144467346|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.13|STANDARD_ERROR_OF_MEAN|0.64||0.834|TWO_SIDED|95.0|-1.12|1.39||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.39|-1.12|0.834
72472146|NCT02209181|144467346|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|2.73|STANDARD_ERROR_OF_MEAN|0.65|<|0.001|TWO_SIDED|95.0|1.45|4.0||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||4.00|1.45|<0.001
72472147|NCT02209181|144467347|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.36|STANDARD_ERROR_OF_MEAN|0.64||0.573|TWO_SIDED|95.0|-0.9|1.63||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.63|-0.90|0.573
72472148|NCT02209181|144467347|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.49|STANDARD_ERROR_OF_MEAN|0.64||0.448|TWO_SIDED|95.0|-0.77|1.74||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.74|-0.77|0.448
72472149|NCT02209181|144467347|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|2.98|STANDARD_ERROR_OF_MEAN|0.64|<|0.001|TWO_SIDED|95.0|1.71|4.25||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||4.25|1.71|<0.001
72472150|NCT02209181|144467347|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.12|STANDARD_ERROR_OF_MEAN|0.64||0.848|TWO_SIDED|95.0|-1.13|1.38||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.38|-1.13|0.848
72472151|NCT02209181|144467347|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|2.62|STANDARD_ERROR_OF_MEAN|0.64|<|0.001|TWO_SIDED|95.0|1.35|3.89||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||3.89|1.35|<0.001
72472152|NCT02209181|144467348|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.23|STANDARD_ERROR_OF_MEAN|0.64||0.72|TWO_SIDED|95.0|-1.04|1.5||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.50|-1.04|0.720
72472153|NCT02209181|144467348|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.19|STANDARD_ERROR_OF_MEAN|0.64||0.763|TWO_SIDED|95.0|-1.07|1.45||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.45|-1.07|0.763
72472154|NCT02209181|144467348|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|2.82|STANDARD_ERROR_OF_MEAN|0.65|<|0.001|TWO_SIDED|95.0|1.55|4.09||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||4.09|1.55|<0.001
72472155|NCT02209181|144467348|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.64||0.952|TWO_SIDED|95.0|-1.3|1.22||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.22|-1.30|0.952
72472156|NCT02209181|144467348|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|2.59|STANDARD_ERROR_OF_MEAN|0.65|<|0.001|TWO_SIDED|95.0|1.31|3.86||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||3.86|1.31|<0.001
72397758|NCT02801942|144301730|OTHER||Mean Difference (Final Values)|3.95|STANDARD_ERROR_OF_MEAN|2.481|||TWO_SIDED|95.0|-1.25|9.15|||||The mean difference in TH2 cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||9.15|-1.25|
72623007|NCT04918771|144776371|SUPERIORITY|||||||0.4926|||||||Fisher Exact|||||||0.4926
72397759|NCT02801942|144301730|OTHER||Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.627|||TWO_SIDED|95.0|-1.28|1.38|||||The mean difference in TH22 cells (Healthy participants versus NOT1D participants) by FNA method has been presented.|||1.38|-1.28|
72623008|NCT04918771|144776372|SUPERIORITY|||||||0.021|||||||Fisher Exact|||Comparison of severity distributions.||||0.021
72623009|NCT04918771|144776372|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison for outcome distribution.||||1.00
72623010|NCT04918771|144776373|SUPERIORITY|||||||0.7848|||||||Median test|||Comparison for Visit 1.||||0.7848
72623011|NCT04918771|144776373|SUPERIORITY|||||||0.9596|||||||Median test|||Comparison for Visit 2.||||0.9596
72472157|NCT02209181|144467349|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.14|STANDARD_ERROR_OF_MEAN|0.63||0.821|TWO_SIDED|95.0|-1.1|1.39||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.39|-1.10|0.821
72472158|NCT02209181|144467349|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.63||0.978|TWO_SIDED|95.0|-1.25|1.22||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.22|-1.25|0.978
72472159|NCT02209181|144467349|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|2.88|STANDARD_ERROR_OF_MEAN|0.63|<|0.001|TWO_SIDED|95.0|1.63|4.13||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||4.13|1.63|<0.001
72472160|NCT02209181|144467349|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.63||0.799|TWO_SIDED|95.0|-1.39|1.07||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.07|-1.39|0.799
72472161|NCT02209181|144467349|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|2.73|STANDARD_ERROR_OF_MEAN|0.63|<|0.001|TWO_SIDED|95.0|1.49|3.98||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||3.98|1.49|<0.001
72472162|NCT02209181|144467350|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.25|STANDARD_ERROR_OF_MEAN|0.7||0.726|TWO_SIDED|95.0|-1.62|1.13||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.13|-1.62|0.726
72472163|NCT02209181|144467350|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.69||0.869|TWO_SIDED|95.0|-1.48|1.25||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.25|-1.48|0.869
72472164|NCT02209181|144467350|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|2.52|STANDARD_ERROR_OF_MEAN|0.7|<|0.001|TWO_SIDED|95.0|1.13|3.9||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||3.90|1.13|<0.001
72472165|NCT02209181|144467350|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.13|STANDARD_ERROR_OF_MEAN|0.69||0.851|TWO_SIDED|95.0|-1.24|1.5||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.50|-1.24|0.851
72472166|NCT02209181|144467350|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|2.76|STANDARD_ERROR_OF_MEAN|0.7|<|0.001|TWO_SIDED|95.0|1.38|4.15||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||4.15|1.38|<0.001
72506513|NCT01097616|144544855|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-7.4||||0.00298|TWO_SIDED|95.0|-12.3|-2.5||By multiplicity strategy above, overall Type I error among primary hypotheses was controlled at two-sided 5% significance level.|Longitudinal Data Analysis|Model terms: baseline value, age group, region, gender, treatment, time, and time by treatment interaction.||The null hypothesis, that suvorexant HD did not differ from placebo for Month 1 sTSOm, had planned marginal power of 99.9%. Sleep maintenance (sTSTm, WASO) and sleep onset (sTSOm, LPS) endpoints were tested at two-sided 2.5% significance level. Both Month 1 endpoints for sleep maintenance must be significant to test Month 3 endpoints; the same approach was used for sleep onset endpoints.||-2.5|-12.3|0.00298
72506514|NCT01097616|144544856|SUPERIORITY_OR_OTHER||[Difference in Least Squares Means|-8.4||||0.00019|TWO_SIDED|95.0|-12.8|-4.0||By multiplicity strategy above, overall Type I error among primary hypotheses was controlled at two-sided 5% significance level.|Longitudinal Data Analysis|Model terms: baseline value, age group, region, gender, treatment, time, and time by treatment interaction.||The null hypothesis, that suvorexant HD did not differ from placebo for Month 3 sTSOm, had planned marginal power of 99.6%. Sleep maintenance (sTSTm, WASO) and sleep onset (sTSOm, LPS) endpoints were tested at two-sided 2.5% significance level. Both Month 1 endpoints for sleep maintenance must be significant to test Month 3 endpoints; the same approach was used for sleep onset endpoints.||-4.0|-12.8|0.00019
72506515|NCT01097616|144544857|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-11.2||||2e-05|TWO_SIDED|95.0|-16.3|-6.1||By multiplicity strategy above, overall Type I error among primary hypotheses was controlled at two-sided 5% significance level.|Longitudinal Data Analysis|Model terms: baseline value, age group, region, gender, treatment, time, and time by treatment interaction.||The null hypothesis, that suvorexant HD did not differ from placebo for Month 1 LPS, had planned marginal power of 81.4%. Sleep maintenance (sTSTm, WASO) and sleep onset (sTSOm, LPS) endpoints were tested at two-sided 2.5% significance level. Both Month 1 endpoints for sleep maintenance must be significant to test Month 3 endpoints; the same approach was used for sleep onset endpoints.||-6.1|-16.3|0.00002
72506516|NCT01097616|144544858|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-9.4||||0.00037|TWO_SIDED|95.0|-14.6|-4.3||By multiplicity strategy above, overall Type I error among primary hypotheses was controlled at two-sided 5% significance level.|Longitudinal Data Analysis|Model terms: baseline value, age group, region, gender, treatment, time, and time by treatment interaction.||The null hypothesis, that suvorexant HD did not differ from placebo for Month 3 LPS, had planned marginal power of 76.2%. Sleep maintenance (sTSTm, WASO) and sleep onset (sTSOm, LPS) endpoints were tested at two-sided 2.5% significance level. Both Month 1 endpoints for sleep maintenance must be significant to test Month 3 endpoints; the same approach was used for sleep onset endpoints.||-4.3|-14.6|0.00037
72623012|NCT04918771|144776373|SUPERIORITY|||||||0.6902|||||||Median test|||Comparison for Visit 3.||||0.6902
72623013|NCT04918771|144776374|SUPERIORITY|||||||0.3266|||||||Median test|||Comparison for Visit 1.||||0.3266
72472167|NCT02209181|144467351|SUPERIORITY_OR_OTHER|||||||0.042||||||The significance threshold level was 0.05 (two-sided). P-Value is from Log-rank test comparing survival curves.|Log Rank|||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. Subjects who withdrew from the study before 24 hours, but did not use rescue therapy, were censored at the time of discontinuation. Subjects who did not rescue medication during the 24-hour study period had their time to rescue set to 24 hours and were censored at 24 hours.||||0.042
72397760|NCT02801942|144301730|OTHER||Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.438|||TWO_SIDED|95.0|-0.93|0.91|||||The mean difference in TH22 cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||0.91|-0.93|
72472168|NCT02209181|144467351|SUPERIORITY_OR_OTHER|||||||0.779||||||The significance threshold level was 0.05 (two-sided). P-Value is from Log-rank test comparing survival curves.|Log Rank|||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. Subjects who withdrew from the study before 24 hours, but did not use rescue therapy, were censored at the time of discontinuation. Subjects who did not rescue medication during the 24-hour study period had their time to rescue set to 24 hours and were censored at 24 hours.||||0.779
72472169|NCT02209181|144467351|SUPERIORITY_OR_OTHER||||||<|0.001||||||The significance threshold level was 0.05 (two-sided). P-Value is from Log-rank test comparing survival curves.|Log Rank|||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. Subjects who withdrew from the study before 24 hours, but did not use rescue therapy, were censored at the time of discontinuation. Subjects who did not rescue medication during the 24-hour study period had their time to rescue set to 24 hours and were censored at 24 hours.||||<0.001
72472170|NCT02209181|144467351|SUPERIORITY_OR_OTHER|||||||0.196||||||The significance threshold level was 0.05 (two-sided). P-Value is from Log-rank test comparing survival curves.|Log Rank|||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. Subjects who withdrew from the study before 24 hours, but did not use rescue therapy, were censored at the time of discontinuation. Subjects who did not rescue medication during the 24-hour study period had their time to rescue set to 24 hours and were censored at 24 hours.||||0.196
72472171|NCT02209181|144467351|SUPERIORITY_OR_OTHER|||||||0.006||||||The significance threshold level was 0.05 (two-sided). P-Value is from Log-rank test comparing survival curves.|Log Rank|||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. Subjects who withdrew from the study before 24 hours, but did not use rescue therapy, were censored at the time of discontinuation. Subjects who did not rescue medication during the 24-hour study period had their time to rescue set to 24 hours and were censored at 24 hours.||||0.006
72472172|NCT02209181|144467352|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|1.5|STANDARD_ERROR_OF_MEAN|0.21|<|0.001|TWO_SIDED|95.0|1.1|1.9||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.9|1.1|<0.001
72472173|NCT02209181|144467352|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.4|STANDARD_ERROR_OF_MEAN|0.21||0.077|TWO_SIDED|95.0|0.0|0.8||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.8|-0.0|0.077
72472174|NCT02209181|144467352|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|1.2|STANDARD_ERROR_OF_MEAN|0.21|<|0.001|TWO_SIDED|95.0|0.8|1.6||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.6|0.8|<0.001
72472175|NCT02209181|144467352|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|0.21|<|0.001|TWO_SIDED|95.0|-1.6|-0.7||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||-0.7|-1.6|<0.001
72472176|NCT02209181|144467352|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.21||0.148|TWO_SIDED|95.0|-0.7|0.1||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.1|-0.7|0.148
72472177|NCT01681277|144467449|SUPERIORITY_OR_OTHER||Slope|1.2208|STANDARD_ERROR_OF_MEAN|0.1386|||TWO_SIDED|95.0|0.9354|1.5062|||||"Dose proportionality was explored using the power model (ANCOVA). The perfect dose proportionality would correspond to a slope β of 1.~PK endpoints on the log-transformed scale. Standard Error of the mean is actually the Standard Error of the slope"|This was non confirmatory testing (Single dose). Dose proportionality of BI 113608 for Cmax,ss was analysed.||1.5062|0.9354|
72472178|NCT01681277|144467451|SUPERIORITY_OR_OTHER||Slope|1.3135|STANDARD_ERROR_OF_MEAN|0.1206|||TWO_SIDED|95.0|1.0652|1.5618|||||"Dose proportionality was explored using the power model (ANCOVA). The perfect dose proportionality would correspond to a slope β of 1.~PK endpoints on the log-transformed scale. Standard Error of the mean is actually the Standard Error of the slope"|This was non confirmatory testing (Single dose). Dose proportionality of BI 113608 for AUCt,ss was analysed.||1.5618|1.0652|
72472179|NCT04486625|144467456|OTHER|Analysis of variance (ANOVA) was used to compare the natural log transformed AUC0-24,ss between the normal renal function group (Reference) and the severe renal impairment group (Test). The geometric least squares mean point estimate and the associated 90% confidence intervals (CIs) for the difference of each comparison was estimated.|Ratio (%) of adjusted geometric means|79.48|||||TWO_SIDED|90.0|66.52|94.96||||||||94.96|66.52|
72472180|NCT04486625|144467457|OTHER|ANOVA was used to compare the natural log transformed Cmax between the normal renal function group (Reference) and the severe renal impairment group (Test). The geometric least squares mean point estimate and the associated 90% CIs for the difference of each comparison was estimated.|Ratio (%) of adjusted geometric means|75.58|||||TWO_SIDED|90.0|66.1|86.43||||||||86.43|66.10|
72472181|NCT04486625|144467458|OTHER|ANOVA was used to compare the natural log transformed AUC0-24,ss between the normal renal function group (Reference) and the severe renal impairment group (Test). The geometric least squares mean point estimate and the associated 90% CIs for the difference of each comparison was estimated.|Ratio (%) of of adjusted geometric means|124.19|||||TWO_SIDED|90.0|100.18|153.97||||||||153.97|100.18|
72623014|NCT04918771|144776374|SUPERIORITY|||||||0.093|||||||Median test|||Comparison for Visit 2.||||0.0930
72506517|NCT01097616|144544859|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|13.6||||7e-05|TWO_SIDED|95.0|6.9|20.3|||Longitudinal Data Analysis|Model terms: baseline value, age group, region, gender, treatment, time, and time by treatment interaction.||Sleep maintenance and sleep onset endpoints were tested at two-sided 2.5% significance level. Both Month 1 endpoints for sleep maintenance must be significant to test Month 3 endpoints and either the subjective or objective Month 3 endpoint must be significant to test the Week 1/Night 1 endpoints. A sleep maintenance LD endpoint was tested if ≥1 HD Month 3 endpoint for sleep maintenance and corresponding HD endpoint were significant. The same approach was used for sleep onset endpoints.||20.3|6.9|0.00007
72506518|NCT01097616|144544859|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|21.4|||<|1e-05|TWO_SIDED|95.0|15.5|27.4|||Longitudinal Data Analysis|Model terms: baseline value, age group, region, gender, treatment, time, and time by treatment interaction.||The null hypothesis, that suvorexant HD did not differ from placebo for Week 1 sTSTm, had planned marginal power of 98.3%. Sleep maintenance (sTSTm, WASO) and sleep onset (sTSOm, LPS) endpoints were tested at two-sided 2.5% significance level. Both Month 1 endpoints for sleep maintenance must be significant to test Month 3 endpoints and either subjective or objective Month 3 endpoint must be significant to test Week 1/Night 1 endpoints. The same approach was used for sleep onset endpoints.||27.4|15.5|<0.00001
72506519|NCT01097616|144544860|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|16.3||||0.00016|TWO_SIDED|95.0|7.9|24.8|||Longitudinal Data Analysis|Model terms: baseline value, age group, region, gender, treatment, time, and time by treatment interaction.||Sleep maintenance (sTSTm, WASO) and sleep onset (sTSOm, LPS) endpoints were tested at two-sided 2.5% significance level. Both Month 1 endpoints for sleep maintenance must be significant to test Month 3 endpoints. A sleep maintenance LD endpoint was tested if ≥1 HD Month 3 endpoint for sleep maintenance and corresponding HD endpoint were significant. The same approach was used for sleep onset endpoints.||24.8|7.9|0.00016
72506520|NCT01097616|144544861|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|10.7||||0.01711|TWO_SIDED|95.0|1.9|19.5|||Longitudinal Data Analysis|Model terms: baseline value, age group, region, gender, treatment, time, and time by treatment interaction.||Sleep maintenance (sTSTm, WASO) and sleep onset (sTSOm, LPS) endpoints were tested at two-sided 2.5% significance level. Both Month 1 endpoints for sleep maintenance must be significant to test Month 3 endpoints. A sleep maintenance LD endpoint was tested if ≥1 HD Month 3 endpoint for sleep maintenance and corresponding HD endpoint were significant. The same approach was used for sleep onset endpoints.||19.5|1.9|0.01711
72506521|NCT01097616|144544862|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-32.5|||<|1e-05|TWO_SIDED|95.0|-39.3|-25.7|||Longitudinal Data Analysis|Model terms: baseline value, age group, region, gender, treatment, time, and time by treatment interaction.||Sleep maintenance and sleep onset endpoints were tested at two-sided 2.5% significance level. Both Month 1 endpoints for sleep maintenance must be significant to test Month 3 endpoints and either the subjective or objective Month 3 endpoint must be significant to test the Week 1/Night 1 endpoints. A sleep maintenance LD endpoint was tested if ≥1 HD Month 3 endpoint for sleep maintenance and corresponding HD endpoint were significant. The same approach was used for sleep onset endpoints.||-25.7|-39.3|<0.00001
72506522|NCT01097616|144544862|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-38.4|||<|1e-05|TWO_SIDED|95.0|-44.5|-32.3|||Longitudinal Data Analysis|Model terms: baseline value, age group, region, gender, treatment, time, and time by treatment interaction.||The null hypothesis, that suvorexant HD did not differ from placebo for Night 1 WASO, had planned marginal power of 100.0%. Sleep maintenance (sTSTm, WASO) and sleep onset (sTSOm, LPS) endpoints were tested at two-sided 2.5% significance level. Both Month 1 endpoints for sleep maintenance must be significant to test Month 3 endpoints and either subjective or objective Month 3 endpoint must be significant to test Week 1/Night 1 endpoints. The same approach was used for sleep onset endpoints.||-32.3|-44.5|<0.00001
72506523|NCT01097616|144544863|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-26.4|||<|1e-05|TWO_SIDED|95.0|-34.3|-18.4|||Longitudinal Data Analysis|Model terms: baseline value, age group, region, gender, treatment, time, and time by treatment interaction.||Sleep maintenance (sTSTm, WASO) and sleep onset (sTSOm, LPS) endpoints were tested at two-sided 2.5% significance level. Both Month 1 endpoints for sleep maintenance must be significant to test Month 3 endpoints. A sleep maintenance LD endpoint was tested if ≥1 HD Month 3 endpoint for sleep maintenance and corresponding HD endpoint were significant. The same approach was used for sleep onset endpoints.||-18.4|-34.3|<0.00001
72506524|NCT01097616|144544864|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-16.6||||9e-05|TWO_SIDED|95.0|-24.8|-8.3|||Longitudinal Data Analysis|Model terms: baseline value, age group, region, gender, treatment, time, and time by treatment interaction.||Sleep maintenance (sTSTm, WASO) and sleep onset (sTSOm, LPS) endpoints were tested at two-sided 2.5% significance level. Both Month 1 endpoints for sleep maintenance must be significant to test Month 3 endpoints. A sleep maintenance LD endpoint was tested if ≥1 HD Month 3 endpoint for sleep maintenance and corresponding HD endpoint were significant. The same approach was used for sleep onset endpoints.||-8.3|-24.8|0.00009
72506525|NCT01097616|144544865|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-5.6||||0.01564|TWO_SIDED|95.0|-10.2|-1.1|||Longitudinal Data Analysis|Model terms: baseline value, age group, region, gender, treatment, time, and time by treatment interaction.||Sleep maintenance and sleep onset endpoints were tested at two-sided 2.5% significance level. Both Month 1 endpoints for sleep maintenance must be significant to test Month 3 endpoints and either the subjective or objective Month 3 endpoint must be significant to test the Week 1/Night 1 endpoints. A sleep maintenance LD endpoint was tested if ≥1 HD Month 3 endpoint for sleep maintenance and corresponding HD endpoint were significant. The same approach was used for sleep onset endpoints.||-1.1|-10.2|0.01564
72506526|NCT01097616|144544865|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-5.7||||0.00609|TWO_SIDED|95.0|-9.7|-1.6|||Longitudinal Data Analysis|Model terms: baseline value, age group, region, gender, treatment, time, and time by treatment interaction.||The null hypothesis, that suvorexant HD did not differ from placebo for Week 1 sTSOm, had planned marginal power of 99.6%. Sleep maintenance (sTSTm, WASO) and sleep onset (sTSOm, LPS) endpoints were tested at two-sided 2.5% significance level. Both Month 1 endpoints for sleep maintenance must be significant to test Month 3 endpoints and either subjective or objective Month 3 endpoint must be significant to test Week 1/Night 1 endpoints. The same approach was used for sleep onset endpoints.||-1.6|-9.7|0.00609
72623015|NCT04918771|144776374|SUPERIORITY|||||||0.2308|||||||Median test|||Comparison for Visit 3.||||0.2308
72623016|NCT04918771|144776375|SUPERIORITY|||||||0.661|||||||Median test|||Comparison for Visit 1/Systolic blood pressure.||||0.6610
72472182|NCT04486625|144467459|OTHER|ANOVA was used to compare the natural log transformed Cmax between the normal renal function group (Reference) and the severe renal impairment group (Test). The geometric least squares mean point estimate and the associated 90% CIs for the difference of each comparison was estimated.|Ratio (%) of adjusted geometric means|102.42|||||TWO_SIDED|90.0|87.55|119.83||||||||119.83|87.55|
72472183|NCT02271984|144467486|SUPERIORITY_OR_OTHER||Ratio (%)|39.9|||||TWO_SIDED|90.0|34.7|46.0|||||Percentage of Geometric Least Squares (LS) Mean Ratio (Treatment A/Treatment B) is reported.|||46.0|34.7|
72472184|NCT02271984|144467486|SUPERIORITY_OR_OTHER||Ratio (%)|27.3|||||TWO_SIDED|90.0|22.5|33.2|||||Percentage of Geometric LS Mean Ratio (Treatment C1/Treatment A) is reported.|||33.2|22.5|
72472185|NCT02271984|144467486|SUPERIORITY_OR_OTHER||Ratio (%)|260.2|||||TWO_SIDED|90.0|214.0|316.4|||||Percentage of Geometric LS Mean Ratio (Treatment C2/Treatment A) is reported.|||316.4|214.0|
72472186|NCT02271984|144467486|SUPERIORITY_OR_OTHER||Ratio (%)|167.1|||||TWO_SIDED|90.0|143.9|194.0|||||Percentage of Geometric LS Mean Ratio (Treatment A/Treatment D) is reported.|||194.0|143.9|
72472187|NCT02271984|144467486|SUPERIORITY_OR_OTHER||Ratio (%)|115.7|||||TWO_SIDED|90.0|99.8|134.1|||||Percentage of Geometric LS Mean Ratio (Treatment E/Treatment A) is reported.|||134.1|99.8|
72472188|NCT04624243|144467500|SUPERIORITY|It was hypothesized that MK-8189 16 mg is superior to placebo in reducing Week 6 PANSS change from baseline|LS Mean Difference|-2.8||||0.241|TWO_SIDED|97.5|-8.3|2.6|||ANCOVA|||||2.6|-8.3|0.241
72472189|NCT04624243|144467500|SUPERIORITY|It was hypothesized that MK-8189 24 mg is superior to placebo in reducing Week 6 PANSS change from baseline|LS Mean Difference|-0.7||||0.784|TWO_SIDED|97.5|-6.3|4.9|||ANCOVA|||||4.9|-6.3|0.784
72472190|NCT04624243|144467502|SUPERIORITY|It was hypothesized that MK-8189 16 mg is superior to placebo in reducing Week 6 PANSS PSS change from baseline|LS Mean Difference|-1.3||||0.096|TWO_SIDED|97.5|-3.1|0.5|||ANCOVA|||||0.5|-3.1|0.096
72472191|NCT04624243|144467502|SUPERIORITY|It was hypothesized that MK-8189 24 mg is superior to placebo in reducing Week 6 PANSS PSS change from baseline|LS Mean Difference|-1.4||||0.094|TWO_SIDED|97.5|-3.2|0.5|||ANCOVA|||||0.5|-3.2|0.094
72472192|NCT04624243|144467503|SUPERIORITY|It was hypothesized that MK-8189 16 mg is superior to placebo in reducing Week 6 CGI-S change from baseline|LS Mean Difference|-0.2||||0.254|TWO_SIDED|97.5|-0.5|0.1|||ANCOVA|||||0.1|-0.5|0.254
72472193|NCT04624243|144467503|SUPERIORITY|It was hypothesized that MK-8189 24 mg is superior to placebo in reducing Week 6 CGI-S change from baseline|LS Mean Difference|0.0||||0.959|TWO_SIDED|97.5|-0.3|0.3|||ANCOVA|||||0.3|-0.3|0.959
72472194|NCT04624243|144467507|SUPERIORITY|Estimated Treatment Difference vs Risperidone|LS Mean Difference|-8.5|||<|0.001|TWO_SIDED|97.5|-10.4|-6.5|||ANCOVA|Covariates were treatment, stratum (US Black, US-Non-Black, Other), gender (male, female), and with baseline value, the duration of illness and age||||-6.5|-10.4|<0.001
72472195|NCT04624243|144467507|SUPERIORITY|Estimated Treatment Difference vs Risperidone|LS Mean Difference|-7.3|||<|0.001|TWO_SIDED|97.5|-9.3|-5.2|||ANCOVA|Covariates were treatment, stratum (US Black, US-Non-Black, Other), gender (male, female), and with baseline value, the duration of illness and age||||-5.2|-9.3|<0.001
72472196|NCT04624243|144467508|SUPERIORITY|Estimated Treatment Difference vs Risperidone|LS Mean Difference|-6.0|||<|0.001|TWO_SIDED|97.5|-7.4|-4.6|||ANCOVA|Covariates were treatment, stratum (US Black, US-Non-Black, Other), gender (male, female), and with baseline value, the duration of illness and age||||-4.6|-7.4|<0.001
72472197|NCT04624243|144467508|SUPERIORITY|Estimated Treatment Difference vs Risperidone|LS Mean Difference|-5.6|||<|0.001|TWO_SIDED|97.5|-7.0|-4.2|||ANCOVA|Covariates were treatment, stratum (US Black, US-Non-Black, Other), gender (male, female), and with baseline value, the duration of illness and age||||-4.2|-7.0|<0.001
72472198|NCT04024462|144467516|NON_INFERIORITY|The null hypothesis could be rejected and non-inferiority concluded if the lower bound of the 90% confidence interval of the geometric mean ratio was ≥0.8.|Geometric Mean Ratio|1.07|||||TWO_SIDED|90.0|0.99|1.15|||||The CtroughSC/CtroughIV geometric mean ratio was calculated as the SC dose of pertuzumab (Arm B) relative to the pertuzumab IV dose (Arm A).|The null hypothesis was that the pertuzumab Arm B SC dose is inferior to the pertuzumab Arm A IV dose (i.e., the CtroughSC/CtroughIV geometric mean ratio of the SC dose of pertuzumab relative to the IV dose is not greater than 0.8).||1.15|0.99|
72472199|NCT04024462|144467517|NON_INFERIORITY|The null hypothesis could be rejected and non-inferiority concluded if the lower bound of the 90% confidence interval of the geometric mean ratio was ≥0.8. Non-inferiority was tested in hierarchical order after the primary outcome measure, to adjust for multiple statistical testing and control the type I error at one sided 5% significance level.|Geometric Mean Ratio|1.55|||||TWO_SIDED|90.0|1.44|1.67|||||The CtroughSC/CtroughIV geometric mean ratio was calculated as the SC dose of trastuzumab (Arm B) relative to the trastuzumab IV dose (Arm A).|The null hypothesis was that the trastuzumab Arm B SC dose is inferior to the Arm A trastuzumab IV dose (i.e., the CtroughSC/CtroughIV geometric mean ratio of the SC dose of trastuzumab relative to the IV dose is not greater than 0.8).||1.67|1.44|
72472200|NCT04024462|144467518|OTHER|Descriptive analysis only. tpCR was analyzed outside of a hypothesis-testing framework and according to the methodology outlined in the outcome measure description.|Difference in tpCR Rate|-0.88|||||TWO_SIDED|95.0|-15.21|13.45|||||Difference in tpCR rate was calculated as Arm B: PH FDC SC minus Arm A: P+H IV.|||13.45|-15.21|
72472201|NCT00789360|144467540|OTHER||Maximum LS mean change difference|0.0917|||||TWO_SIDED|90.0|-0.028|0.212|||||Maximum difference occurred at 10 hours|The largest treatment difference (Loxapine - Placebo) in change in FEV1 from baseline by spirometry||0.212|-0.028|
72472202|NCT00789360|144467541|OTHER||Maximum LS mean change difference|-0.154|||||TWO_SIDED|90.0|-0.29|-0.019|||||Greatest difference occurred at 9 hours after Dose 1|||-0.019|-0.290|
72472203|NCT03559062|144467567|OTHER||||||<|0.0001|||||||Mixed-effects model for repeated measure|||||||<0.0001
72397761|NCT02801942|144301731|OTHER||Mean Difference (Final Values)|0.3|STANDARD_ERROR_OF_MEAN|3.63|||TWO_SIDED|95.0|-7.4|8.0|||||The mean difference in TFH cells-like Reg T cells (Healthy participants versus NOT1D participants) by FNA method has been presented.|||8.00|-7.40|
72472204|NCT03559062|144467568|OTHER||||||<|0.0001|||||||Mixed-effects model for repeated measure|||||||<0.0001
72472205|NCT03559062|144467569|OTHER|||||||0.0546|||||||Mixed-effects model for repeated measure|||||||0.0546
72623017|NCT04918771|144776375|SUPERIORITY|||||||0.4884|||||||Median test|||Comparison for Visit 2/Systolic blood pressure.||||0.4884
72623018|NCT04918771|144776375|SUPERIORITY|||||||0.3494|||||||Median test|||Comparison for Visit 3/Systolic blood pressure.||||0.3494
72397762|NCT02801942|144301731|OTHER||Mean Difference (Final Values)|0.72|STANDARD_ERROR_OF_MEAN|2.694|||TWO_SIDED|95.0|-4.9|6.35|||||The mean difference in TFH cells-like Reg T cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||6.35|-4.90|
72397763|NCT02801942|144301731|OTHER||Mean Difference (Final Values)|-4.9|STANDARD_ERROR_OF_MEAN|2.377|||TWO_SIDED|95.0|-9.89|0.08|||||The mean difference in TH1 cells-like Reg T cells (Healthy participants versus NOT1D participants) by FNA method has been presented.|||0.08|-9.89|
72397764|NCT02801942|144301731|OTHER||Mean Difference (Final Values)|-3.29|STANDARD_ERROR_OF_MEAN|1.682|||TWO_SIDED|95.0|-6.82|0.24|||||The mean difference in TH1 cells-like Reg T cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||0.24|-6.82|
72506527|NCT01097616|144544866|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-5.4||||0.05191|TWO_SIDED|95.0|-10.9|0.0|||Longitudinal Data Analysis|Model terms: baseline value, age group, region, gender, treatment, time, and time by treatment interaction.||Sleep maintenance (sTSTm, WASO) and sleep onset (sTSOm, LPS) endpoints were tested at two-sided 2.5% significance level. Both Month 1 endpoints for sleep maintenance must be significant to test Month 3 endpoints. A sleep maintenance LD endpoint was tested if ≥1 HD Month 3 endpoint for sleep maintenance and corresponding HD endpoint were significant. The same approach was used for sleep onset endpoints.||0.0|-10.9|0.05191
72506528|NCT01097616|144544867|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-5.2||||0.03771|TWO_SIDED|95.0|-10.2|-0.3|||Longitudinal Data Analysis|Model terms: baseline value, age group, region, gender, treatment, time, and time by treatment interaction.||Sleep maintenance (sTSTm, WASO) and sleep onset (sTSOm, LPS) endpoints were tested at two-sided 2.5% significance level. Both Month 1 endpoints for sleep maintenance must be significant to test Month 3 endpoints. A sleep maintenance LD endpoint was tested if ≥1 HD Month 3 endpoint for sleep maintenance and corresponding HD endpoint were significant. The same approach was used for sleep onset endpoints.||-0.3|-10.2|0.03771
72506529|NCT01097616|144544870|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-9.6||||0.00041|TWO_SIDED|95.0|-14.9|-4.3|||Longitudinal Data Analysis|Model terms: baseline value, age group, region, gender, treatment, time, and time by treatment interaction.||Sleep maintenance and sleep onset endpoints were tested at two-sided 2.5% significance level. Both Month 1 endpoints for sleep maintenance must be significant to test Month 3 endpoints and either the subjective or objective Month 3 endpoint must be significant to test the Week 1/Night 1 endpoints. A sleep maintenance LD endpoint was tested if ≥1 HD Month 3 endpoint for sleep maintenance and corresponding HD endpoint were significant. The same approach was used for sleep onset endpoints.||-4.3|-14.9|0.00041
72506530|NCT01097616|144544870|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-10.3||||2e-05|TWO_SIDED|95.0|-15.0|-5.5|||Longitudinal Data Analysis|Model terms: baseline value, age group, region, gender, treatment, time, and time by treatment interaction.||The null hypothesis, that suvorexant HD did not differ from placebo for Night 1 LPS, had planned marginal power of 100.0%. Sleep maintenance (sTSTm, WASO) and sleep onset (sTSOm, LPS) endpoints were tested at two-sided 2.5% significance level. Both Month 1 endpoints for sleep maintenance must be significant to test Month 3 endpoints and either subjective or objective Month 3 endpoint must be significant to test Week 1/Night 1 endpoints. The same approach was used for sleep onset endpoints.||-5.5|-15.0|0.00002
72506531|NCT01097616|144544871|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-10.3||||0.0004|TWO_SIDED|95.0|-16.0|-4.6|||Longitudinal Data Analysis|Model terms: baseline value, age group, region, gender, treatment, time, and time by treatment interaction.||Sleep maintenance (sTSTm, WASO) and sleep onset (sTSOm, LPS) endpoints were tested at two-sided 2.5% significance level. Both Month 1 endpoints for sleep maintenance must be significant to test Month 3 endpoints. A sleep maintenance LD endpoint was tested if ≥1 HD Month 3 endpoint for sleep maintenance and corresponding HD endpoint were significant. The same approach was used for sleep onset endpoints.||-4.6|-16.0|0.00040
72506532|NCT01097616|144544872|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-8.1||||0.00606|TWO_SIDED|95.0|-13.8|-2.3|||Longitudinal Data Analysis|Model terms: baseline value, age group, region, gender, treatment, time, and time by treatment interaction.||Sleep maintenance (sTSTm, WASO) and sleep onset (sTSOm, LPS) endpoints were tested at two-sided 2.5% significance level. Both Month 1 endpoints for sleep maintenance must be significant to test Month 3 endpoints. A sleep maintenance LD endpoint was tested if ≥1 HD Month 3 endpoint for sleep maintenance and corresponding HD endpoint were significant. The same approach was used for sleep onset endpoints.||-2.3|-13.8|0.00606
72506533|NCT01996319|144544873|SUPERIORITY_OR_OTHER||null hypoth|0.2021|||<|0.0001|TWO_SIDED|95.0|0.1583|0.246|||ANCOVA|||||0.2460|0.1583|<0.0001
72506534|NCT01996319|144544874|SUPERIORITY_OR_OTHER||Null hypoth|36.7126||||0.0399|TWO_SIDED|95.0|1.7241|71.7011|||ANCOVA|||||71.7011|1.7241|0.0399
72506535|NCT00591227|144544881|SUPERIORITY_OR_OTHER_LEGACY|||||||0.58||95.0|||||t-test, 1 sided|||||||0.58
72506536|NCT00117338|144544915|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.01||||0.775||95.0|-0.06|0.08|||ANCOVA|Model terms: treatment, region (US, non-US) and baseline FEV1 as covariate||||0.08|-0.06|0.775
72397765|NCT02801942|144301731|OTHER||Mean Difference (Final Values)|-0.29|STANDARD_ERROR_OF_MEAN|1.036|||TWO_SIDED|95.0|-2.67|2.1|||||The mean difference in TH1 TH17 TH2 cells-like Reg T cells (Healthy participants versus NOT1D participants) by FNA method has been presented.|||2.10|-2.67|
72397766|NCT02801942|144301731|OTHER||Mean Difference (Final Values)|-2.8|STANDARD_ERROR_OF_MEAN|1.929|||TWO_SIDED|95.0|-7.2|1.59|||||The mean difference in TH1 TH17 TH2 cells-like Reg T cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||1.59|-7.20|
72506537|NCT00117338|144544916|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.02||||0.931||95.0|-0.41|0.45|||ANCOVA|Model terms: treatment, region (US, non-US) and baseline FEV1 as covariate||||0.45|-0.41|0.931
72506538|NCT00117338|144544917|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.99||||0.975||95.0|0.61|1.61|||Regression, Logistic|Model terms: treatment and baseline FEV1 as covariate||||1.61|0.61|0.975
72506539|NCT00117338|144544918|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.02||||0.612||95.0|-0.05|0.09|||ANCOVA|Model terms: treatment, region (US, non-US) and baseline FEV1 as covariate||||0.09|-0.05|0.612
72506540|NCT00117338|144544919|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.01||||0.774||95.0|-0.06|0.08|||ANCOVA|Model terms: treatment, region (US, non-US) and baseline FEV1 as covariate||||0.08|-0.06|0.774
72506541|NCT00117338|144544920|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.04||||0.173||95.0|-0.02|0.11|||ANCOVA|Model terms: treatment, region (US, non-US) and baseline FEV1 as covariate||||0.11|-0.02|0.173
72472206|NCT03445533|144467571|SUPERIORITY|||||||0.9394||||||p-value was calculated for percentage difference (B-A) using a Cochran-Mantel-Haenszel (CMH) test stratified by metastasis stage and BRAF mutation.|Cochran-Mantel-Haenszel|ORR and OS comprise a primary endpoint family; both have a priori hypotheses and were tested for statistical significance.||The ORR was defined as a percentage of subjects meeting criteria of CR and PR to calculate the p-value.||||0.9394
72506542|NCT00117338|144544921|SUPERIORITY_OR_OTHER_LEGACY|||||||0.58||95.0|||||ANCOVA|ANCOVA model (Nonparametric) based on Tukey's normalized ranks with terms treatment, region (US, non-US) and baseline FEV1 as covariate||||||0.580
72472207|NCT03445533|144467572|SUPERIORITY||Cox Proportional Hazard|0.955||||0.6775|TWO_SIDED|95.0|0.77|1.186||The p-value was calculated using the log rank test stratified by metastasis stage and BRAF mutation.|Log Rank|ORR and OS comprise a primary endpoint family; both have a priori hypotheses. ORR will be tested first followed by OS.|Hazard ratio and 95% CI (B/A) are estimated using a Cox proportional hazards model stratified by metastasis stage and BRAF mutation.|||1.186|0.770|0.6775
72472208|NCT03926195|144467602|OTHER||Difference in Percentage|5.8|||||TWO_SIDED|95.0|-7.5|19.2|||||Difference in percentage and 95% confidence interval (CI) was based on a stratified Mantel-Haenszel test.|||19.2|-7.5|
72472209|NCT03926195|144467604|OTHER||Median Difference (Final Values)|-1.5|||||TWO_SIDED|95.0|-6.4|3.5|||||Difference in Medians and 95% CI for change from baseline at Week 13 was based on quantile regression.|||3.5|-6.4|
72472210|NCT03926195|144467606|OTHER||Median Difference (Final Values)|-0.2|||||TWO_SIDED|95.0|-37.1|36.8|||||Difference in medians and 95% CI for change from baseline at Week 13 was based on quantile regression.|||36.8|-37.1|
72472211|NCT03926195|144467608|OTHER||Median Difference (Final Values)|7.4|||||TWO_SIDED|95.0|-6.0|20.8|||||Difference in Medians and 95% CI for change from baseline at Week 13 was based on quantile regression.|||20.8|-6.0|
72472212|NCT03926195|144467610|OTHER||Median Difference (Final Values)|-0.3|||||TWO_SIDED|95.0|-0.6|0.1|||||Difference in Medians and 95% CI for change from baseline at Week 13 was based on quantile regression.|||0.1|-0.6|
72472213|NCT03926195|144467612|OTHER||Median Difference (Final Values)|-1.0|||||TWO_SIDED|95.0|-3.0|1.0|||||Difference in Medians and 95% CI for change from baseline at Week 13 was based on quantile regression.|||1|-3|
72506543|NCT05057988|144544925|OTHER|paired T test|Mean Difference (Net)|1.04|STANDARD_DEVIATION|1.8|<|0.001|TWO_SIDED|95.0|0.53|1.55|||t-test, 2 sided|||||1.55|0.53|<.001
72623019|NCT04918771|144776375|SUPERIORITY|||||||0.9531|||||||Median test|||Comparison for Visit 1/Diastolic blood pressure.||||0.9531
72472214|NCT00955708|144467656|OTHER|Primary endpoint was estimated using the Kaplan-Meier method. In addition, Greenwood's formula was used to calculate the lower one-sided 95% confidence bound.|Kaplan-Meier Rate|95.3|||||ONE_SIDED|95.0|94.0||||||The lower one-sided 95% confidence bound was pre-specified to be greater than 92.5%.|The endpoint data reflected here is a modified primary endpoint analysis requested by the Food and Drug Administration early in the registry to include data that is related to the left ventricular lead function in a chronic setting.|||94.0|
72623020|NCT04918771|144776375|SUPERIORITY|||||||0.5506|||||||Median test|||Comparison for Visit 2/Diastolic blood pressure.||||0.5506
72397767|NCT02801942|144301731|OTHER||Mean Difference (Final Values)|-1.44|STANDARD_ERROR_OF_MEAN|2.117|||TWO_SIDED|95.0|-5.98|3.11|||||The mean difference in TH1 TH2 cells-like Reg T cells (Healthy participants versus NOT1D participants) by FNA method has been presented.|||3.11|-5.98|
72472215|NCT00955708|144467656|OTHER|Primary endpoint was estimated using the Kaplan-Meier method. In addition, Greenwood's formula was used to calculate the lower one-sided 95% confidence bound.|Kaplan-Meier Rate|100.0|||||ONE_SIDED|95.0|100.0|||||||The non-modified primary endpoint analysis initially included confirmed chronic LV lead related complications that result in permanent loss of therapy, invasive intervention, injury or death, and are deemed attributable to a structural lead failure by an independent Clinical Events Committee (CEC). These results are represented here.|||100|
72472216|NCT01016262|144467657|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0047||||||Statistical significance was assessed at the two-sided 5% level. As there was only a single pre-specified primary analysis, there was no adjustment for multiplicity.|Cochran-Mantel-Haenszel|||The comparison between MAX-002 and placebo during the DB phase with respect to the primary outcome measure was the single pre-specified primary analysis, and the null hypothesis was that the percentages were equal between the two groups.||||0.0047
72472217|NCT01016262|144467657|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0346||||||Statistical significance was assessed at the two-sided 5% level. As there was only a single pre-specified primary analysis, there was no adjustment for multiplicity.|Cochran-Mantel-Haenszel|||The comparison between Canasa® and placebo during the DB phase with respect to the primary outcome measure was a pre-specified tertiary analysis only.||||0.0346
72472218|NCT00479882|144467677|NON_INFERIORITY_OR_EQUIVALENCE|Clinical equivalence LDL-C reduction was established if the 95% CI for the difference between these two treatments in percent change from baseline in LDL-C fell within ±3%.|Difference in Least squares mean|2.4|||||TWO_SIDED|95.0|1.3|3.4|||ANOVA|Factors for sequence, participant within sequence, period and treatment||||3.4|1.3|
72506544|NCT05057988|144544926|OTHER|Paired T test|Mean Difference (Net)|0.98|STANDARD_DEVIATION|8.17||0.208|TWO_SIDED|95.0|-1.42|3.37|||t-test, 2 sided|||||3.37|-1.42|.208
72506545|NCT05057988|144544927|OTHER|Paired T test|Mean Difference (Net)|0.86|STANDARD_DEVIATION|1.2|<|0.001|TWO_SIDED|95.0|0.52|1.2|||t-test, 2 sided|||||1.20|0.52|<.001
72506546|NCT05057988|144544928|OTHER|Paired t test|Mean Difference (Net)|0.81|STANDARD_DEVIATION|5.65||0.328|TWO_SIDED|95.0|-0.84|2.47|||t-test, 1 sided|||||2.47|-.84|.328
72506547|NCT05057988|144544929|OTHER|Paired T test|Mean Difference (Final Values)|2.71|STANDARD_DEVIATION|4.95|<|0.001|TWO_SIDED|95.0|1.26|4.16|||t-test, 1 sided|||||4.16|1.26|<.001
72506548|NCT05057988|144544930|OTHER|Paired T test|Mean Difference (Final Values)|0.65|STANDARD_DEVIATION|6.38||0.486|TWO_SIDED|95.0|-1.22|2.53|||t-test, 1 sided|||||2.53|-1.22|.486
72506549|NCT05057988|144544931|OTHER|Paired T test|Mean Difference (Final Values)|-0.24|STANDARD_DEVIATION|7.57||0.832|TWO_SIDED|95.0|-2.46|1.99|||t-test, 2 sided|||||1.99|-2.46|.832
72623021|NCT04918771|144776375|SUPERIORITY|||||||0.8259|||||||Median test|||Comparison for Visit 3/Diastolic blood pressure.||||0.8259
72623022|NCT04918771|144776376|SUPERIORITY|||||||0.49|||||||Fisher Exact|||||||0.49
72623023|NCT01287208|144776381|SUPERIORITY|||||||0.16|||||||Wilcoxon (Mann-Whitney)|||||||0.16
72623024|NCT01287208|144776384|SUPERIORITY|||||||0.59|||||||t-test, 2 sided|||||||0.59
72397768|NCT02801942|144301731|OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|2.047|||TWO_SIDED|95.0|-4.59|3.99|||||The mean difference in TH1 TH2 cells-like Reg T cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||3.99|-4.59|
72397769|NCT02801942|144301731|OTHER||Mean Difference (Final Values)|-1.47|STANDARD_ERROR_OF_MEAN|2.645|||TWO_SIDED|95.0|-6.99|4.06|||||The mean difference in TH17 cells-like Reg T cells (Healthy participants versus NOT1D participants) by FNA method has been presented.|||4.06|-6.99|
72397770|NCT02801942|144301731|OTHER||Mean Difference (Final Values)|0.53|STANDARD_ERROR_OF_MEAN|2.185|||TWO_SIDED|95.0|-4.05|5.11|||||The mean difference in TH17 cells-like Reg T cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||5.11|-4.05|
72397771|NCT02801942|144301731|OTHER||Mean Difference (Final Values)|-2.25|STANDARD_ERROR_OF_MEAN|4.299|||TWO_SIDED|95.0|-11.23|6.73|||||The mean difference in TH2 cells-like Reg T cells (Healthy participants versus NOT1D participants) by FNA method has been presented.|||6.73|-11.23|
72397772|NCT02801942|144301731|OTHER||Mean Difference (Final Values)|3.42|STANDARD_ERROR_OF_MEAN|3.472|||TWO_SIDED|95.0|-3.84|10.67|||||The mean difference in TH2 cells-like Reg T cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||10.67|-3.84|
72397773|NCT02801942|144301731|OTHER||Mean Difference (Final Values)|-0.65|STANDARD_ERROR_OF_MEAN|1.153|||TWO_SIDED|95.0|-3.3|2.0|||||The mean difference in TH22 cells-like Reg T cells (Healthy participants versus NOT1D participants) by FNA method has been presented.|||2.00|-3.30|
72506550|NCT05057988|144544932|OTHER|Paired T test|Mean Difference (Net)|-0.43|STANDARD_DEVIATION|3.06||0.34|TWO_SIDED|95.0|-1.33|0.47|||t-test, 2 sided|||||0.47|-1.33|.340
72506551|NCT05057988|144544934|SUPERIORITY||Mean Difference (Net)|0.28|STANDARD_ERROR_OF_MEAN|0.31||0.37|TWO_SIDED|95.0|-0.34|0.89|||t-test, 2 sided|paired sample t test||paired sample t test||0.89|-0.34|0.370
72506552|NCT05057988|144544934|OTHER|Paired T test|Mean Difference (Net)|0.28|STANDARD_DEVIATION|2.09||0.37|TWO_SIDED|95.0|-0.34|0.89|||t-test, 2 sided|||||.89|-.34|.370
72506553|NCT01703819|144544938|SUPERIORITY_OR_OTHER|||||||0.7726||||||Threshold less than or equal to 0.05. The final analysis demonstrated reasonable doubt of the implicit normality assumption of the two sets of AUC data, thus medians presented for efficacy analysis. Need for further investigation (ex-post analyses).|ANCOVA|||The null-hypotheses of no treatment differences were tested by the two-sided t-tests from the respective ANCOVAs.||||0.7726
72506554|NCT01703819|144544939|SUPERIORITY_OR_OTHER|||||||0.5702||||||Threshold less than or equal to 0.05. The final analysis demonstrated reasonable doubt of the implicit normality assumption of the two sets of AUC data, thus medians presented for efficacy analysis. Need for further investigation (ex-post analyses).|ANCOVA|||The null-hypotheses of no treatment differences were tested by the two-sided t-tests from the respective ANCOV As.||||0.5702
72506555|NCT02145156|144544951|SUPERIORITY_OR_OTHER|||||||0.36|||||||Fisher Exact|||||||.36
72565795|NCT02709486|144662702|SUPERIORITY||Least Square Mean Difference|-0.86|STANDARD_ERROR_OF_MEAN|0.16|<|0.0001|TWO_SIDED|95.0|-1.16|-0.55|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.||-0.55|-1.16|<.0001
72397774|NCT02801942|144301731|OTHER||Mean Difference (Final Values)|-0.17|STANDARD_ERROR_OF_MEAN|0.869|||TWO_SIDED|95.0|-2.06|1.72|||||The mean difference in TH22 cells-like Reg T cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||1.72|-2.06|
72506556|NCT02145156|144544951|SUPERIORITY_OR_OTHER|||||||0.18|||||||Fisher Exact|||||||.18
72506557|NCT02145156|144544951|SUPERIORITY_OR_OTHER|||||||0.22|||||||Fisher Exact|||||||.22
72506558|NCT02145156|144544951|SUPERIORITY_OR_OTHER|||||||0.88|||||||Fisher Exact|||||||.88
72506559|NCT02145156|144544952|SUPERIORITY_OR_OTHER|||||||0.35|||||||Fisher Exact|||||||0.35
72506560|NCT02145156|144544952|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||||||1.0
72506561|NCT02145156|144544952|SUPERIORITY_OR_OTHER|||||||0.23|||||||Fisher Exact|||||||.23
72506562|NCT02145156|144544952|SUPERIORITY_OR_OTHER|||||||0.23|||||||Fisher Exact|||||||.23
72506563|NCT02145156|144544953|SUPERIORITY_OR_OTHER|||||||0.37|||||||Fisher Exact|||||||0.37
72506564|NCT02145156|144544953|SUPERIORITY_OR_OTHER|||||||0.23|||||||Fisher Exact|||||||.23
72506565|NCT02145156|144544953|SUPERIORITY_OR_OTHER|||||||0.25|||||||Fisher Exact|||||||.25
72506566|NCT02145156|144544953|SUPERIORITY_OR_OTHER|||||||0.7|||||||Fisher Exact|||||||.70
72506567|NCT02145156|144544954|SUPERIORITY_OR_OTHER|||||||0.59|||||||Fisher Exact|||||||0.59
72506568|NCT02145156|144544954|SUPERIORITY_OR_OTHER|||||||0.52|||||||Fisher Exact|||||||.52
72506569|NCT02145156|144544954|SUPERIORITY_OR_OTHER|||||||0.71|||||||Fisher Exact|||||||.71
72506570|NCT02145156|144544954|SUPERIORITY_OR_OTHER|||||||0.34|||||||Fisher Exact|||||||.34
72506571|NCT02145156|144544955|SUPERIORITY_OR_OTHER|||||||0.16|||||||Fisher Exact|||||||0.16
72506572|NCT02145156|144544955|SUPERIORITY_OR_OTHER|||||||0.15|||||||Fisher Exact|||||||.15
72506573|NCT02145156|144544955|SUPERIORITY_OR_OTHER|||||||0.98|||||||Fisher Exact|||||||.98
72506574|NCT02145156|144544955|SUPERIORITY_OR_OTHER|||||||0.34|||||||Fisher Exact|||||||.34
72506575|NCT02145156|144544956|SUPERIORITY_OR_OTHER|||||||0.37|||||||Fisher Exact|||||||0.37
72506576|NCT02145156|144544956|SUPERIORITY_OR_OTHER|||||||0.23|||||||Fisher Exact|||||||.23
72506577|NCT02145156|144544956|SUPERIORITY_OR_OTHER|||||||0.25|||||||Fisher Exact|||||||.25
72506578|NCT02145156|144544956|SUPERIORITY_OR_OTHER|||||||0.7|||||||Fisher Exact|||||||.70
72506579|NCT02145156|144544957|SUPERIORITY_OR_OTHER|||||||0.87|||||||Chi-squared|||||||0.87
72506580|NCT02145156|144544957|SUPERIORITY_OR_OTHER|||||||0.62|||||||Chi-squared|||||||0.62
72506581|NCT02145156|144544957|SUPERIORITY_OR_OTHER|||||||0.81|||||||Chi-squared|||||||0.81
72506582|NCT02145156|144544957|SUPERIORITY_OR_OTHER|||||||0.76|||||||Chi-squared|||||||0.76
72472219|NCT00479882|144467677|NON_INFERIORITY_OR_EQUIVALENCE|Clinical equivalence LDL-C reduction was established if the 95% CI for the difference between these two treatments in percent change from baseline in LDL-C fell within ±3%.|Difference in Least Squares Mean|1.4|||||TWO_SIDED|95.0|0.4|2.4|||ANOVA|Factors for sequence, participant within sequence, period and treatment||||2.4|0.4|
72472220|NCT00479882|144467678|NON_INFERIORITY_OR_EQUIVALENCE|Clinical equivalence HDL-C reduction was established if the 95% CI for the difference between these two treatments in percent change from baseline in LDL-C fell within ±4%.|Difference in Least Squares Mean|-0.2|||||TWO_SIDED|95.0|-1.4|1.0|||ANOVA|Factors for sequence, participant within sequence, period and treatment||||1.0|-1.4|
72472221|NCT00479882|144467678|NON_INFERIORITY_OR_EQUIVALENCE|Clinical equivalence HDL-C reduction was established if the 95% CI for the difference between these two treatments in percent change from baseline in LDL-C fell within ±4%.|Difference in Least Squares Mean|-0.8|||||TWO_SIDED|95.0|-1.9|0.2|||ANOVA|Factors for sequence, participant within sequence, period and treatment||||0.2|-1.9|
72472222|NCT00479882|144467679|SUPERIORITY_OR_OTHER||Difference in Percentage|-0.2||||0.685|TWO_SIDED|95.0|-1.2|0.8|||Fisher Exact||Wilson's Method|Periods I/II||0.8|-1.2|0.685
72472223|NCT00479882|144467679|SUPERIORITY_OR_OTHER||Difference in Percentage|-0.3|||||TWO_SIDED|95.0|-1.8|1.1|||||Wilson's Method|Period III||1.1|-1.8|
72472224|NCT00479882|144467679|SUPERIORITY_OR_OTHER||Difference in Percentage|-0.3||||0.753|TWO_SIDED|95.0|-1.6|0.9|||Fisher Exact||Wilson's Method|Periods I/II||0.9|-1.6|0.753
72472225|NCT00479882|144467679|SUPERIORITY_OR_OTHER||Difference in Percentage|0.2|||||TWO_SIDED|95.0|-0.8|1.4|||||Wilson's Method|Period III||1.4|-0.8|
72472226|NCT00479882|144467680|SUPERIORITY_OR_OTHER||Difference in Percentage|0.0|||||TWO_SIDED|95.0|-0.7|0.6|||Fisher Exact||Wilson's Method|Periods I/II||0.6|-0.7|
72472227|NCT00479882|144467680|SUPERIORITY_OR_OTHER||Difference in Percentage|0.4|||||TWO_SIDED|95.0|-0.5|1.5|||||Wilson's Method|Period III||1.5|-0.5|
72472228|NCT00479882|144467680|SUPERIORITY_OR_OTHER||Difference in Percentage|0.2||||0.617|TWO_SIDED|95.0|-0.6|1.1|||Fisher Exact||Wilson's Method|Periods I/II||1.1|-0.6|0.617
72472229|NCT00479882|144467680|SUPERIORITY_OR_OTHER||Difference in Percentage|0.0|||||TWO_SIDED|95.0|-0.8|0.9|||||Wilson's Method|Period III||0.9|-0.8|
72506583|NCT02145156|144544958|SUPERIORITY_OR_OTHER|||||||0.7|||||||Chi-squared|||||||0.70
72506584|NCT02145156|144544958|SUPERIORITY_OR_OTHER|||||||0.41|||||||Chi-squared|||||||0.41
72472230|NCT00479882|144467681|SUPERIORITY_OR_OTHER||Difference in Percentage|0.0|||||TWO_SIDED|95.0|-0.7|0.6|||Fisher Exact||Wilson's Method|Periods I/II||0.6|-0.7|
72472231|NCT00479882|144467681|SUPERIORITY_OR_OTHER||Difference in Percentage|0.0|||||TWO_SIDED|95.0|-0.9|0.8|||||Wilson's Method|Period III||0.8|-0.9|
72472232|NCT00479882|144467681|SUPERIORITY_OR_OTHER||Difference in Percentage|0.0|||||TWO_SIDED|95.0|-0.6|0.7|||Fisher Exact||Wilson's Method|Periods I/II||0.7|-0.6|
72472233|NCT00479882|144467681|SUPERIORITY_OR_OTHER||Difference in Percentage|0.0|||||TWO_SIDED|95.0|-0.8|0.9|||||Wilson's Method|Period III||0.9|-0.8|
72472234|NCT00479882|144467682|SUPERIORITY_OR_OTHER||Difference in Percentage|0.0|||||TWO_SIDED|95.0|-0.7|0.6|||Fisher Exact||Wilson's Method|Periods I/II||0.6|-0.7|
72472235|NCT00479882|144467682|SUPERIORITY_OR_OTHER||Difference in Percentage|0.0|||||TWO_SIDED|95.0|-0.9|0.8|||||Wilson's Method|Period III||0.8|-0.9|
72472236|NCT00479882|144467682|SUPERIORITY_OR_OTHER||Difference in Percentage|0.0|||||TWO_SIDED|95.0|-0.6|0.7|||Fisher Exact||Wilson's Method|Periods I/II||0.7|-0.6|
72472237|NCT00479882|144467682|SUPERIORITY_OR_OTHER||Difference in Percentage|0.0|||||TWO_SIDED|95.0|-0.8|0.9|||||Wilson's Method|Period III||0.9|-0.8|
72472238|NCT00479882|144467683|SUPERIORITY_OR_OTHER||Difference in Percentage|-0.2||||0.497|TWO_SIDED|95.0|-0.9|0.5|||Fisher Exact|||Periods I/II||0.5|-0.9|0.497
72472239|NCT00479882|144467684|SUPERIORITY_OR_OTHER||Difference in Percentage|-0.3||||0.449|TWO_SIDED|95.0|-1.4|0.6|||Fisher Exact||Wilson's Method|Periods I/II||0.6|-1.4|0.449
72472240|NCT00479882|144467684|SUPERIORITY_OR_OTHER||Difference in Percentage|-0.3|||||TWO_SIDED|95.0|-1.6|0.9|||||Wilson's Method|Period III||0.9|-1.6|
72472241|NCT00479882|144467684|SUPERIORITY_OR_OTHER||Difference in Percentage|0.2||||0.685|TWO_SIDED|95.0|-0.8|1.2|||Fisher Exact||Wilson's Method|Period I/II||1.2|-0.8|0.685
72472242|NCT00479882|144467684|SUPERIORITY_OR_OTHER||Difference in Percentage|0.3|||||TWO_SIDED|95.0|-1.0|1.6|||||Wilson's Method|Period III||1.6|-1.0|
72472243|NCT00479882|144467685|SUPERIORITY_OR_OTHER||Difference in Percentage|-1.2||||0.02|TWO_SIDED|95.0|-2.4|-0.2|||Fisher Exact||Wilson's Method|Periods I/II||-0.2|-2.4|0.020
72472244|NCT00479882|144467685|SUPERIORITY_OR_OTHER||Difference in Percentage|-0.3|||||TWO_SIDED|95.0|-1.6|0.9|||||Wilson's Method|Period III||0.9|-1.6|
72472245|NCT00479882|144467685|SUPERIORITY_OR_OTHER||Difference in Percentage|-0.5||||0.452|TWO_SIDED|95.0|-1.6|0.5|||Fisher Exact||Wilson's Method|Periods I/II||0.5|-1.6|0.452
72472246|NCT00479882|144467685|SUPERIORITY_OR_OTHER||Difference in Percentage|-0.4|||||TWO_SIDED|95.0|-1.9|1.0|||||Wilson's Method|Period III||1.0|-1.9|
72472247|NCT00479882|144467686|SUPERIORITY_OR_OTHER||Difference in Percentage|0.0|||||TWO_SIDED|95.0|-0.6|0.6|||||Wilson's Method|Periods I/II||0.6|-0.6|
72472248|NCT00479882|144467686|SUPERIORITY_OR_OTHER||Difference in Percentage|0.2|||||TWO_SIDED|95.0|-0.7|1.2|||||Wilson's Method|Period III||1.2|-0.7|
72506585|NCT02145156|144544958|SUPERIORITY_OR_OTHER|||||||0.59|||||||Chi-squared|||||||0.59
72506586|NCT02145156|144544958|SUPERIORITY_OR_OTHER|||||||0.74|||||||Chi-squared|||||||0.74
72506587|NCT02145156|144544959|SUPERIORITY_OR_OTHER|||||||0.38|||||||Chi-squared|||||||0.38
72506588|NCT02145156|144544959|SUPERIORITY_OR_OTHER|||||||0.17|||||||Chi-squared|||||||0.17
72506589|NCT02145156|144544959|SUPERIORITY_OR_OTHER|||||||0.6|||||||Chi-squared|||||||0.60
72506590|NCT02145156|144544959|SUPERIORITY_OR_OTHER|||||||0.35|||||||Chi-squared|||||||0.35
72506591|NCT02145156|144544960|SUPERIORITY_OR_OTHER|||||||0.39|||||||Chi-squared|||||||0.39
72506592|NCT02145156|144544960|SUPERIORITY_OR_OTHER|||||||0.51|||||||Chi-squared|||||||0.51
72506593|NCT02145156|144544960|SUPERIORITY_OR_OTHER|||||||0.49|||||||Chi-squared|||||||0.49
72506594|NCT02145156|144544960|SUPERIORITY_OR_OTHER|||||||0.14|||||||Chi-squared|||||||0.14
72506595|NCT02145156|144544961|SUPERIORITY_OR_OTHER|||||||0.09|||||||Chi-squared|||||||0.09
72506596|NCT02145156|144544961|SUPERIORITY_OR_OTHER|||||||0.51|||||||Chi-squared|||||||0.51
72506597|NCT02145156|144544961|SUPERIORITY_OR_OTHER|||||||0.15|||||||Chi-squared|||||||0.15
72506598|NCT02145156|144544961|SUPERIORITY_OR_OTHER|||||||0.03|||||||Chi-squared|||||||0.03
72472249|NCT00479882|144467686|SUPERIORITY_OR_OTHER||Difference in Percentage|0.2|||||TWO_SIDED|95.0|-0.5|0.9|||||Wilson's Method|Periods I/II||0.9|-0.5|
72472250|NCT00479882|144467686|SUPERIORITY_OR_OTHER||Difference in Percentage|0.2|||||TWO_SIDED|95.0|-0.6|1.3|||||Wilson's Method|Period III||1.3|-0.6|
72472251|NCT00479882|144467687|SUPERIORITY_OR_OTHER||Difference in Percentage|-1.4|||||TWO_SIDED|95.0|-6.6|3.8|||||Wilson's Score Method|Periods I/II||3.8|-6.6|
72472252|NCT00479882|144467687|SUPERIORITY_OR_OTHER||Difference in Percentage|-1.9|||||TWO_SIDED|95.0|-8.1|4.3|||||Wilson's Score Method|Period III||4.3|-8.1|
72472253|NCT00479882|144467687|SUPERIORITY_OR_OTHER||Difference in Percentage|0.1|||||TWO_SIDED|95.0|-5.2|5.3|||||Wilson's Score Method|Periods I/II||5.3|-5.2|
72472254|NCT00479882|144467687|SUPERIORITY_OR_OTHER||Difference in Percentage|-2.8|||||TWO_SIDED|95.0|-8.9|3.4|||||Wilson's Score Method|Period III||3.4|-8.9|
72472255|NCT00479882|144467688|SUPERIORITY_OR_OTHER||Difference in Percentage|-0.2|||||TWO_SIDED|95.0|-2.5|2.1|||||Wilson's Score Method|Periods I/II||2.1|-2.5|
72472256|NCT00479882|144467688|SUPERIORITY_OR_OTHER||Difference in Percentage|2.3|||||TWO_SIDED|95.0|-0.5|5.2|||||Wilson's Score Method|Period III||5.2|-0.5|
72472257|NCT00479882|144467688|SUPERIORITY_OR_OTHER||Difference in Percentage|1.6|||||TWO_SIDED|95.0|-1.0|4.2|||||Wilson's Score Method|Periods I/II||4.2|-1.0|
72472258|NCT00479882|144467688|SUPERIORITY_OR_OTHER||Difference in Percentage|2.0|||||TWO_SIDED|95.0|-0.8|5.0|||||Wilson's Score Method|Period III||5.0|-0.8|
72472259|NCT00479882|144467691|SUPERIORITY_OR_OTHER||Difference in Percentage|0.2|||||TWO_SIDED|95.0|-0.5|0.9|||||Wilson's Score Method|Periods I/II||0.9|-0.5|
72472260|NCT00479882|144467691|SUPERIORITY_OR_OTHER||Difference in Percentage|-0.2|||||TWO_SIDED|95.0|-0.9|0.5|||||Wilson's Score Method|Periods I/II||0.5|-0.9|
72472261|NCT00479882|144467692|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|1.0||||0.341|TWO_SIDED|95.0|-1.1|3.1|||ANOVA|Factors for treatment, country and gender||||3.1|-1.1|0.341
72472262|NCT00479882|144467692|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|3.7||||0.004|TWO_SIDED|95.0|1.2|6.1|||ANOVA|Factors for treatment, country and gender.||||6.1|1.2|0.004
72472263|NCT00479882|144467693|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-0.4||||0.69|TWO_SIDED|95.0|-2.3|1.5|||ANOVA|Factors for treatment, country and gender||||1.5|-2.3|0.690
72472264|NCT00479882|144467693|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|0.2||||0.879|TWO_SIDED|95.0|-1.9|2.3|||ANOVA|Factors for treatment, country and gender||||2.3|-1.9|0.879
72472265|NCT01370655|144467694|NON_INFERIORITY_OR_EQUIVALENCE|"Hypothesis supported if the upper bound of the two-sided 80% confidence interval (CI; equivalent to a one-sided upper 90% CI) is~≤0 mmHg"|Difference in Least square (LS) means|-7.4|||||TWO_SIDED|80.0|-10.6|-4.1|||||MK-7145 6 mg LS mean minus Placebo LS mean|Type I error rate of alpha=0.10 (1-sided) is specified for testing of the hypothesis.||-4.1|-10.6|
72472266|NCT01370655|144467694|NON_INFERIORITY_OR_EQUIVALENCE|Hypothesis supported if the upper bound of the two-sided 90% CI (equivalent to a one-sided upper 95% CI) for the difference ≤ 3.8 mmHg.|Difference in LS means|-5.4|||||TWO_SIDED|90.0|-9.2|-1.6|||||MK-7145 6 mg LS mean minus HCTZ 25 mg LS mean|Type I error rate of alpha=0.05 (1-sided) is specified for testing of the hypothesis.||-1.6|-9.2|
72472267|NCT01370655|144467694|SUPERIORITY_OR_OTHER||Difference in LS means|-4.8|||||TWO_SIDED|90.0|-9.0|-0.5|||||MK-7145 3 mg LS mean minus HCTZ 25 mg LS mean|||-0.5|-9.0|
72472268|NCT01370655|144467694|SUPERIORITY_OR_OTHER||Difference in LS Means|-6.7|||||TWO_SIDED|90.0|-11.2|-2.2|||||MK-7145 3 mg LS mean minus Placebo LS mean|||-2.2|-11.2|
72472269|NCT01370655|144467694|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.9|||||TWO_SIDED|90.0|-6.2|2.3|||||HCTZ 25 mg LS mean minus Placebo LS mean|||2.3|-6.2|
72472270|NCT01370655|144467695|SUPERIORITY_OR_OTHER||Difference in LS means|-3.2|||||TWO_SIDED|90.0|-6.1|-0.3|||||MK-7145 6 mg LS mean minus Placebo LS mean|||-0.3|-6.1|
72472271|NCT01370655|144467695|SUPERIORITY_OR_OTHER||Difference in LS means|-2.9|||||TWO_SIDED|90.0|-5.5|-0.2|||||MK-7145 6 mg LS mean minus HCTZ 25 mg LS mean|||-0.2|-5.5|
72472272|NCT01370655|144467695|SUPERIORITY_OR_OTHER||Difference in LS means|-3.0|||||TWO_SIDED|90.0|-6.0|-0.1|||||MK-7145 3 mg LS mean minus HCTZ 25 mg LS mean|||-0.1|-6.0|
72472273|NCT01370655|144467695|SUPERIORITY_OR_OTHER||Difference in LS means|-3.4|||||TWO_SIDED|90.0|-6.5|-0.2|||||MK-7145 3 mg LS mean minus Placebo LS mean|||-0.2|-6.5|
72472274|NCT01370655|144467695|SUPERIORITY_OR_OTHER||Difference in LS means|-0.3|||||TWO_SIDED|90.0|-3.3|2.7|||||HCTZ 25 mg LS mean minus Placebo LS mean|||2.7|-3.3|
72472275|NCT01370655|144467696|NON_INFERIORITY_OR_EQUIVALENCE|Hypothesis supported if the lower bound of the two-sided 80% CI (equivalent to a one-sided lower 90% CI) is \> 89.0 mmol/day.|Difference in LS means|76.5|||||TWO_SIDED|80.0|49.2|103.8|||||MK-7145 6 mg LS mean minus Placebo LS mean|Type I error rate of alpha=0.10 (1-sided) is specified for testing of the hypothesis.||103.8|49.2|
72472276|NCT01370655|144467696|SUPERIORITY_OR_OTHER||Difference in LS means|-63.7|||||TWO_SIDED|90.0|-100.8|-26.7|||||MK-7145 3 mg LS mean minus HCTZ 25 mg LS mean|||-26.7|-100.8|
72472277|NCT01370655|144467696|SUPERIORITY_OR_OTHER||Difference in LS means|-18.1|||||TWO_SIDED|90.0|-49.1|12.9|||||MK-7145 6 mg LS mean minus HCTZ 25 mg LS mean|||12.9|-49.1|
72472278|NCT01370655|144467696|SUPERIORITY_OR_OTHER||Difference in LS means|30.9|||||TWO_SIDED|90.0|-7.0|68.7|||||MK-7145 3 mg LS mean minus Placebo LS mean|||68.7|-7.0|
72472279|NCT01370655|144467696|SUPERIORITY_OR_OTHER||Difference in LS means|94.6|||||TWO_SIDED|90.0|58.8|130.4|||||HCTZ 25 mg LS mean minus Placebo LS mean|||130.4|58.8|
72472280|NCT01370655|144467700|NON_INFERIORITY_OR_EQUIVALENCE|If the upper bound of the two-sided 80% CI (equivalent to a one-sided upper 90% CI) for the difference is \<13 mmol/day the hypothesis will be supported for the 3-mg dose and testing will continue with construction of a two-sided 80% CI for the 6-mg dose (6 mg MK-7145 - placebo). The hypothesis will be supported if one or both doses meet the test criterion.|Difference in LS means|7.9|||||TWO_SIDED|80.0|-2.3|18.2|||||MK-7145 3 mg LS mean minus Placebo LS mean|||18.2|-2.3|
72506599|NCT02145156|144544962|SUPERIORITY_OR_OTHER|||||||0.38|||||||Chi-squared|||||||0.38
72506600|NCT02145156|144544962|SUPERIORITY_OR_OTHER|||||||0.17|||||||Chi-squared|||||||0.17
72506601|NCT02145156|144544962|SUPERIORITY_OR_OTHER|||||||0.6|||||||Chi-squared|||||||0.60
72506602|NCT02145156|144544962|SUPERIORITY_OR_OTHER|||||||0.35|||||||Chi-squared|||||||0.35
72506603|NCT00532883|144544966|SUPERIORITY_OR_OTHER|||||||0.93||95.0||||This is a global test comparing all four treatment arms.|Mixed Models Analysis|||F-test from a longitudinal mixed model (controlling for baseline measurement)testing the hypothesis of no difference in mean percent dense cells between the four treatment groups at Visit 6. The study was originally powered to detect a difference of 20%, but it was stopped early.||||0.93
72472281|NCT01370655|144467700|NON_INFERIORITY_OR_EQUIVALENCE|If the upper bound of the two-sided 80% CI (equivalent to a one-sided upper 90% CI) for the difference is \<13 mmol/day the hypothesis will be supported for the 3-mg dose and testing will continue with construction of a two-sided 80% CI for the 6-mg dose (6 mg MK-7145 - placebo). The hypothesis will be supported if one or both doses meet the test criterion.|Difference in LS means|1.1|||||TWO_SIDED|80.0|-8.5|10.7|||||MK-7145 6 mg LS mean minus Placebo LS mean|||10.7|-8.5|
72472282|NCT01370655|144467700|SUPERIORITY_OR_OTHER||Difference in LS means|3.0|||||TWO_SIDED|90.0|-9.6|15.6|||||MK-7145 3 mg LS mean minus HCTZ 25 mg LS mean|||15.6|-9.6|
72472283|NCT01370655|144467700|SUPERIORITY_OR_OTHER||Difference in LS means|-3.9|||||TWO_SIDED|90.0|-15.0|7.2|||||MK-7145 6 mg LS mean minus HCTZ 25 mg LS mean|||7.2|-15.0|
72472284|NCT01370655|144467700|SUPERIORITY_OR_OTHER||Difference in LS means|5.0|||||TWO_SIDED|90.0|-7.7|17.6|||||HCTZ 25 mg LS mean minus Placebo LS mean|||17.6|-7.7|
72472285|NCT03119233|144467706|OTHER||Lower 97.5% Exact Confidence Limit|68.1|||||ONE_SIDED|97.5|60.9|||||||"The primary effectiveness endpoint is defined as primary patency at 12 months as evidenced by a peak systolic velocity ratio (PSVR)~≤2.5 from DUS and no clinically-driven re-intervention within the stented segment. The primary effectiveness endpoint hypotheses are:~* H0: 12-month success rate of the PQ Bypass System ≤60.4%~* HA: 12-month success rate of the PQ Bypass System \>60.4%"|||60.9|
72472286|NCT03119233|144467707|OTHER|The rate of freedom from 30-day MAE is expected to be no less than 92%. Based on a PG of 84% and an estimated 30-day freedom from MAE rate of 92% for the PQ Bypass System, a sample size of 169 evaluable subjects provides 88% power to test the primary safety hypothesis at the one-sided alpha level of 0.025. The Exact Test Method and Commercial software PASS14 was used to determine the sample size.|Lower 97.5% Exact Confidence Limit|93.0|||||ONE_SIDED|97.5|88.5|||||||"The primary safety endpoint hypotheses are:~* H0: 30-day Freedom from MAE rate of the PQ Bypass System~  ≤84%~* HA: 30-day Freedom from MAE rate of the PQ Bypass System \>84%"|||88.5|
72472287|NCT02057575|144467714|SUPERIORITY||||||<|0.0001||||||PG324 0.01% vs netarsudil|t-test, 2 sided|||||||<0.0001
72472288|NCT02057575|144467714|SUPERIORITY||||||<|0.0001||||||PG324 0.02% vs. netarsudil|t-test, 2 sided|||||||<0.0001
72472289|NCT02057575|144467714|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|PG324 0.01% vs. latanoprost||||||<0.0001
72472290|NCT02057575|144467714|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|PG324 0.02% vs. latanoprost||||||<0.0001
72472291|NCT01735175|144467722|EQUIVALENCE|The testing procedure was set up in a hierarchical structure, where first equivalence between LA-EP2006 and Neulasta® was assessed (margin ±1 day) and only if this was successfully established, non-inferiority between the two products was tested using a tighter margin of -0.6 days.|Mean Difference (Net)|0.07||||0.05|TWO_SIDED|95.0|-0.12|0.26|||ANCOVA|The primary endpoints was analyzed with analysis of covariance (ANCOVA).|The difference between LA-EP2006 and reference pegfilgrastim was 0.07 days (95% CI \[-0.12, 0.26\]). 95% CIs were within the predefined margin of ±1 day confirming equivalence.|"The hierarchical test procedure aimed to show that~1. LA-EP2006 and Neulasta® are equivalent with respect to DSN duration in Cycle 1 (margin±1 day), and, if so~2. LA-EP2006 is non-inferior to Neulasta® with respect to DSN duration in Cycle 1 (margin of -0.6 days)."||0.26|-0.12|0.05
72472292|NCT01735175|144467722|NON_INFERIORITY|The testing procedure was set up in a hierarchical structure, where first equivalence between LA-EP2006 and Neulasta was assessed (margin ±1 day) and only if this was successfully established, non-inferiority between the two products was tested using a tighter margin of -0.6 days.|Mean Difference (Net)|0.07||||0.05|TWO_SIDED|95.0|-0.12|0.26|||ANCOVA|The primary endpoints was analyzed with analysis of covariance (ANCOVA).|LA-EP2006 is non-inferior to Neulasta® because the lower bound of the 95% CI is entirely above the non-inferiority margin of -0.6 days.|"The hierarchical test procedure aimed to show that~1. LA-EP2006 and Neulasta® are equivalent with respect to DSN duration in Cycle 1 (margin±1 day), and, if so~2. LA-EP2006 is non-inferior to Neulasta® with respect to DSN duration in Cycle 1 (margin of -0.6 days)."||0.26|-0.12|0.05
72472293|NCT00755417|144467772|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.96|STANDARD_ERROR_OF_MEAN|0.38||0.0117|TWO_SIDED|97.5|-1.81|-0.11||Based on F test of type III analysis for pairwise comparison at 0.025 level.|ANCOVA|Included treatment and center factors and baseline value as a covariate, tested at the pairwise 0.025 level.||Null hypothesis was that there were no treatment differences relative to placebo in mean change from baseline in average daily number of moderate or severe hot flashes at stable dosing Week 4||-0.11|-1.81|0.0117
72472294|NCT00755417|144467772|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.51|STANDARD_ERROR_OF_MEAN|0.38|<|0.0001|TWO_SIDED|97.5|-2.35|-0.66||Based on F test of type III analysis|ANCOVA|Included treatment and center factors and baseline value as a covariate, tested at the pairwise 0.025 level.||Null hypothesis was that there were no treatment differences relative to placebo in mean change from baseline in average daily number of moderate or severe hot flashes at stable dosing Week 4.||-0.66|-2.35|<0.0001
72472295|NCT00755417|144467773|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.56|STANDARD_ERROR_OF_MEAN|0.42||0.183|TWO_SIDED|97.5|-1.49|0.38||Based on F test of type III analysis.|ANCOVA|Included treatment and center factors and baseline value as a covariate, tested at the pairwise 0.025 level.||Null hypothesis was that there were no treatment differences relative to placebo in mean change from baseline in average daily number of moderate or severe hot flashes at stable dosing Week 12||0.38|-1.49|0.1830
72472296|NCT00755417|144467773|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.53|STANDARD_ERROR_OF_MEAN|0.41||0.1975|TWO_SIDED|97.5|-1.46|0.4||Based on F test of type III analysis.|ANCOVA|Included treatment and center factors and baseline value as a covariate, tested at the pairwise 0.025 level.||Null hypothesis was that there were no treatment differences relative to placebo in mean change from baseline in average daily number of moderate or severe hot flashes at stable dosing Week 12.||0.40|-1.46|0.1975
72565796|NCT02709486|144662702|SUPERIORITY||Least Square Mean Difference|-0.59|STANDARD_ERROR_OF_MEAN|0.16||0.0003|TWO_SIDED|95.0|-0.91|-0.27|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.||-0.27|-0.91|0.0003
72472297|NCT00755417|144467774|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.26|STANDARD_ERROR_OF_MEAN|0.08||0.0016|TWO_SIDED|97.5|-0.44|-0.08||Based on F test of type III analysis.|ANCOVA|Included treatment and center factors and baseline value as a covariate, tested at the pairwise 0.025 level.||Null hypothesis was that there were no treatment differences relative to placebo in mean change from baseline in average daily severity score of moderate or severe hot flashes at stable dosing Week 4.||-0.08|-0.44|0.0016
72472298|NCT00755417|144467774|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.32|STANDARD_ERROR_OF_MEAN|0.08|<|0.0001|TWO_SIDED|97.5|-0.51|-0.14||Based on the F test of type III analysis.|ANCOVA|Included treatment and center factors and baseline value as a covariate, tested at the pairwise 0.025 level.||Null hypothesis was that there were no treatment differences relative to placebo in mean change from baseline in average daily severity score of moderate or severe hot flashes at stable dosing Week 4.||-0.14|-0.51|<0.0001
72472299|NCT00755417|144467775|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.1||0.0433|TWO_SIDED|97.5|-0.43|0.02||Based on the F test of type III analysis.|ANCOVA|Included treatment and center factors and baseline value as a covariate, tested at the pairwise 0.025 level.||Null hypothesis was that there were no treatment differences relative to placebo in mean change from baseline in average daily severity score of moderate or severe hot flashes at stable dosing Week 12.||0.02|-0.43|0.0433
72472300|NCT00755417|144467775|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.1||0.0468|TWO_SIDED|97.5|-0.42|0.03||Based on the F test of type III analysis.|ANCOVA|Included treatment and center factors and baseline value as a covariate, tested at the pairwise 0.025 level.||Null hypothesis was that there were no treatment differences relative to placebo in mean change from baseline in average daily severity score of moderate or severe hot flashes at stable dosing Week 12.||0.03|-0.42|0.0468
72472301|NCT02362503|144467777|SUPERIORITY||Mean Difference (Net)|-0.625|||<|0.0001|TWO_SIDED|95.0|-0.81|-0.441||Hypothesis test:µfostemsavir=µPlacebo where µ is a common intercept.|ANCOVA||Difference in covariate-adjusted least squares means between treatment groups (Fostemsavir 600 mg BID-Placebo) is presented.|||-0.441|-0.810|<0.0001
72472302|NCT02362503|144467778|OTHER||Mean Difference (Net)|45.69|||||TWO_SIDED|95.0|32.95|55.45|||||Difference between treatment groups (fostemsavir 600 mg BID-Placebo) and 95% confidence interval using Newcombe method is presented for \>0.5 log10 c/mL.|||55.45|32.95|
72472303|NCT02362503|144467778|OTHER||Mean Difference (Net)|35.67|||||TWO_SIDED|95.0|24.16|44.25|||||Difference between treatment groups (fostemsavir 600 mg BID-Placebo) and 95% confidence interval using Newcombe method is presented for \>1.0 log10 c/mL.|||44.25|24.16|
72472304|NCT02362503|144467784|OTHER||Mean Difference (Net)|-0.4|||||TWO_SIDED|95.0|-16.8|16.0|||||Difference in covariate-adjusted least squares means between treatment groups (Fostemsavir 600 mg BID-Placebo) is presented.|||16.0|-16.8|
72472305|NCT02362503|144467785|OTHER||Mean Difference (Net)|0.617|||||TWO_SIDED|95.0|0.082|1.151|||||Difference in covariate-adjusted least squares means between treatment groups (Fostemsavir 600 mg BID-Placebo) is presented.|||1.151|0.082|
72472306|NCT03325777|144467838|SUPERIORITY||Slope|0.71|STANDARD_ERROR_OF_MEAN|0.29|=|0.014|TWO_SIDED|95.0|0.14|1.27||a priori threshold is p\<.05|Mixed Models Analysis|Generalized Linear Mixed Models||||1.27|.14|=.014
72472307|NCT03325777|144467839|SUPERIORITY||Mean Difference (Final Values)|172.0|STANDARD_ERROR_OF_MEAN|33.2|<|0.001|TWO_SIDED|95.0|106.0|238.0||a priori threshold for significance was p\<.05|Mixed Models Analysis|||||238|106|<.001
72472308|NCT01266161|144467843|SUPERIORITY||Mean Difference (Final Values)|23.76|||<|0.001|TWO_SIDED|95.0|16.45|31.07||p-Value from analysis of variance (ANOVA) model, with treatment, baseline PSR, gender terms. To protect type I error at 5% significance, 2 primary parameters tested sequentially: SPRID 8-12 not declared significant unless SPRID 0-12 was significant.|ANOVA|||||31.07|16.45|<0.001
72472309|NCT01266161|144467844|SUPERIORITY||Mean Difference (Final Values)|8.42|||<|0.001|TWO_SIDED|95.0|4.13|12.71||p-Value from ANOVA model, with treatment, baseline PSR, and gender terms. To protect type I error at 5% significance, 2 primary parameters tested sequentially: SPRID 8-12 not declared significant unless SPRID 0-12 was significant.|ANOVA|||||12.71|4.13|<0.001
72472310|NCT01266161|144467845|SUPERIORITY||Least-squares means|8.95|||<|0.001|TWO_SIDED|95.0|5.94|11.95||p-Value from ANOVA model with treatment, baseline PSR, and gender terms.|ANOVA|||For SPID 0-12.||11.95|5.94|<0.001
72472311|NCT01266161|144467845|SUPERIORITY||Least-squares means|3.15|||<|0.001|TWO_SIDED|95.0|1.45|4.85||p-Value from ANOVA model with treatment, baseline PSR, and gender terms.|ANOVA|||For SPID 8-12.||4.85|1.45|<0.001
72472312|NCT01266161|144467845|SUPERIORITY||Least-squares means|6.56|||<|0.001|TWO_SIDED|95.0|2.84|10.27||p-Value from ANOVA model with treatment, baseline PSR, and gender terms.|ANOVA|||For SPID 12-24.||10.27|2.84|<0.001
72472313|NCT01266161|144467845|SUPERIORITY||Least-squares means|2.02||||0.091|TWO_SIDED|95.0|-0.33|4.37||p-Value from ANOVA model with treatment, baseline PSR, and gender terms.|ANOVA|||For SPID 20-24.||4.37|-0.33|0.091
72472314|NCT01266161|144467845|SUPERIORITY||Least-squares means|14.95|||<|0.001|TWO_SIDED|95.0|9.12|20.79||p-Value from ANOVA model with treatment, baseline PSR, and gender terms.|ANOVA|||For SPID 0-24.||20.79|9.12|<0.001
72472315|NCT01266161|144467845|SUPERIORITY||Least-squares means|5.87||||0.01|TWO_SIDED|95.0|1.42|10.33||p-Value from ANOVA model with treatment, baseline PSR, and gender terms.|ANOVA|||For SPID 24-36.||10.33|1.42|0.010
72472316|NCT01266161|144467845|SUPERIORITY||Least-squares means|3.48||||0.004|TWO_SIDED|95.0|1.13|5.83||p-Value from ANOVA model with treatment, baseline PSR, and gender terms.|ANOVA|||For SPID 32-36.||5.83|1.13|0.004
72472317|NCT01266161|144467845|SUPERIORITY||Least-squares means|6.09||||0.006|TWO_SIDED|95.0|1.82|10.36||p-Value from ANOVA model with treatment, baseline PSR, and gender terms.|ANOVA|||For SPID 36-48.||10.36|1.82|0.006
72472318|NCT01266161|144467845|SUPERIORITY||Least-squares means|2.41||||0.042|TWO_SIDED|95.0|0.09|4.73||p-Value from ANOVA model with treatment, baseline PSR, and gender terms.|ANOVA|||For SPID 44-48.||4.73|0.09|0.042
72472319|NCT01266161|144467845|SUPERIORITY||Least-squares means|10.97||||0.004|TWO_SIDED|95.0|3.49|18.45||p-Value from ANOVA model with treatment, baseline PSR, and gender terms.|ANOVA|||For SPID 24-48.||18.45|3.49|0.004
72472320|NCT01266161|144467846|SUPERIORITY||Hazard Ratio (HR)|0.18|||<|0.001||95.0|0.1|0.34|||proportional hazards model|||||0.34|0.10|<0.001
72472321|NCT01266161|144467847|SUPERIORITY||Treatment Difference|-48.01|||<|0.001||95.0|-64.46|-31.56||p-Values from the Cochran-Mantel-Haenszel (CMH) test, controlling for baseline PSR and gender.|Cochran-Mantel-Haenszel|||During the first dosing interval (0 to 12 hours).||-31.56|-64.46|<0.001
72506604|NCT05232097|144544976|OTHER|||||||0.005|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: the median of differences of the rumination score before and after therapy equals 0.||||0.005
72506605|NCT05232097|144544977|OTHER|||||||0.11|||||||Chi-squared|||The null hypothesis is that the same number of patients has intragastric pressure peaks indicating rumination before and after therapy.||||0.11
72506606|NCT05232097|144544978|OTHER|||||||0.06|||||||t-test, 2 sided|||Null hypothesis: The differences of means of 15D before and after therapy equals 0.||||0.060
72506607|NCT05232097|144544979|OTHER|||||||0.865|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: The median of differences of WHODAS 2.0 before and after therapy equals 0.||||0.865
72506608|NCT05232097|144544980|OTHER|||||||0.149|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis : the differences of median BDI before and after behavioral therapy equals 0.||||0.149
72506609|NCT05232097|144544981|OTHER|||||||1|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: The differences of median of BAI before and after behavioral therapy equals 0.||||1.000
72506610|NCT05232097|144544982|OTHER|||||||0.102|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: The differences of median weight before and after therapy equals 0.||||0.102
72506611|NCT02853331|144545033|SUPERIORITY||Hazard Ratio (HR)|0.69||||0.00012|TWO_SIDED|95.0|0.56|0.84|||Log Rank||HR based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by IMDC risk group (favorable vs. intermediate vs. poor) and geographic region (North America vs. Western Europe vs. Rest of World).|||0.84|0.56|0.00012
72565797|NCT02709486|144662702|SUPERIORITY||Least Square Mean Difference|-0.72|STANDARD_ERROR_OF_MEAN|0.16|<|0.0001|TWO_SIDED|95.0|-1.04|-0.4|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.||-0.40|-1.04|<.0001
72565798|NCT02709486|144662702|SUPERIORITY||Least Square Mean Difference|-0.74|STANDARD_ERROR_OF_MEAN|0.18|<|0.0001|TWO_SIDED|95.0|-1.08|-0.39|||ANCOVA|||Week 12: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.||-0.39|-1.08|<.0001
72506612|NCT02853331|144545034|SUPERIORITY||Hazard Ratio (HR)|0.53||||5e-05|TWO_SIDED|95.0|0.38|0.74|||Log Rank||HR based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by IMDC risk group (favorable vs. intermediate vs. poor) and geographic region (North America vs. Western Europe vs. Rest of World).|||0.74|0.38|0.00005
72506613|NCT02853331|144545035|SUPERIORITY||Difference in percentages|23.6|||<|0.0001|TWO_SIDED|95.0|17.2|29.9|||Miettinen & Nurminen method|H0: difference in %=0 versus H1: difference in % \>0|Difference in percentages based on Miettinen \& Nurminen method stratified by IMDC risk group (favorable vs. intermediate vs. poor) and geographic region (North America vs. Western Europe vs. Rest of World).|||29.9|17.2|<0.0001
72506614|NCT02853331|144545036|SUPERIORITY||Difference in percentages|11.0|||||TWO_SIDED|95.0|4.8|17.0|||||Difference in percentages based on Miettinen \& Nurminen method stratified by IMDC risk group (favorable vs. intermediate vs. poor) and geographic region (North America vs. Western Europe vs. Rest of World).|||17.0|4.8|
72506615|NCT03290300|144545072|OTHER||||||<|0.0001||||||The pre-specified threshold for statistical significance was p\<0.05.|ANOVA|Repeated measures ANOVA with multiple comparisons to baseline||||||<0.0001
72506616|NCT01520922|144545075|SUPERIORITY_OR_OTHER||Percentage of participants|95.0|||||TWO_SIDED|95.0|84.53|99.44|||||The estimated value represents the percentage of participants with OR (CR+CRi+nPR+PR) while receiving ofatumumab + bendamustine 90 mg/m\^2.|||99.44|84.53|
72506617|NCT01520922|144545075|SUPERIORITY_OR_OTHER||Percentage of participants|74.0|||||TWO_SIDED|95.0|59.67|84.74|||||The estimated value represents the percentage of participants with OR (CR+CRi+nPR+PR) while receiving ofatumumab + bendamustine 70 mg/m\^2.|||84.74|59.67|
72506618|NCT01899144|144545115|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|22.6|STANDARD_ERROR_OF_MEAN|4.87|<|0.0001|TWO_SIDED|95.0|13.0|32.2|||ANOVA|Mixed effect analysis of variance with fixed effects of sequence, treatment group, and period, and random effect for the patient within sequence|Active - Placebo|"The mean difference between each active group and placebo was tested in a sequential manner:~* Albuterol MDPI 180 mcg to placebo~* Albuterol MDPI 90 mcg to placebo~* ProAir HFA 180 mcg to placebo~* ProAir HFA 90 mcg to placebo Each test was 2 sided and done at the 0.05 level of significance. However, if a test was not significant at this level, no further tests were done. This sequential process assured that the overall alpha level for the entire series was not greater than 0.05."||32.20|13.00|<0.0001
72506619|NCT01899144|144545115|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|21.2|STANDARD_ERROR_OF_MEAN|4.87|<|0.0001|TWO_SIDED|95.0|11.6|30.81|||ANOVA|Mixed effect analysis of variance with fixed effects of sequence, treatment group, and period, and random effect for the patient within sequence|Active - Placebo|"The mean difference between each active group and placebo was tested in a sequential manner:~* Albuterol MDPI 180 mcg to placebo~* Albuterol MDPI 90 mcg to placebo~* ProAir HFA 180 mcg to placebo~* ProAir HFA 90 mcg to placebo Each test was 2 sided and done at the 0.05 level of significance. However, if a test was not significant at this level, no further tests were done. This sequential process assured that the overall alpha level for the entire series was not greater than 0.05."||30.81|11.6|<0.0001
72506620|NCT01899144|144545115|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|23.7|STANDARD_ERROR_OF_MEAN|4.85|<|0.0001|TWO_SIDED|95.0|14.13|33.23|||ANOVA|Mixed effect analysis of variance with fixed effects of sequence, treatment group, and period, and random effect for the patient within sequence|Active - Placebo|"The mean difference between each active group and placebo was tested in a sequential manner:~* Albuterol MDPI 180 mcg to placebo~* Albuterol MDPI 90 mcg to placebo~* ProAir HFA 180 mcg to placebo~* ProAir HFA 90 mcg to placebo Each test was 2 sided and done at the 0.05 level of significance. However, if a test was not significant at this level, no further tests were done. This sequential process assured that the overall alpha level for the entire series was not greater than 0.05."||33.23|14.13|<0.0001
72472322|NCT01266161|144467847|SUPERIORITY||Treatment Difference|-25.53|||<|0.001||95.0|-39.78|-11.28||p-Values from the CMH test, controlling for baseline PSR and gender.|Cochran-Mantel-Haenszel|||During the second dosing interval (12 to 24 hours).||-11.28|-39.78|<0.001
72472323|NCT01266161|144467847|SUPERIORITY||Treatment Difference|-24.05||||0.002||95.0|-38.93|-9.18||p-Values from the CMH test, controlling for baseline PSR and gender.|Cochran-Mantel-Haenszel|||During the third dosing interval (24 to 36 hours).||-9.18|-38.93|0.002
72472324|NCT01266161|144467847|SUPERIORITY||Treatment Difference|-13.6||||0.035||95.0|-26.41|-0.79||p-Values from the CMH test, controlling for baseline PSR and gender.|Cochran-Mantel-Haenszel|||During the fourth dosing interval (36 to 48 hours).||-0.79|-26.41|0.035
72472325|NCT01266161|144467847|SUPERIORITY||Treatment Difference|-48.01|||<|0.001||95.0|-64.42|-31.6||p-Values from the CMH test, controlling for baseline PSR and gender.|Cochran-Mantel-Haenszel|||During the study overall (0 to 48 hours).||-31.60|-64.42|<0.001
72472326|NCT01266161|144467847|SUPERIORITY||Cox proportional hazard models|0.086||||0.011|TWO_SIDED|95.0|0.01|0.57|||Andersen-Gill (AG)|||Time to First Dose Rescue Medication Over Entire Study Period (0-48 Hours)||0.57|0.01|0.011
72472327|NCT01266161|144467848|SUPERIORITY||Least squares means|0.84|||<|0.001||95.0|0.5|1.19||p-Values from ANOVA model with treatment, baseline PSR, and gender terms.|ANOVA|||Ibuprofen versus placebo at 0.5 hours.||1.19|0.50|<0.001
72472328|NCT01266161|144467848|SUPERIORITY||Least squares means|1.53|||<|0.001||95.0|1.11|1.94||p-Values from ANOVA model with treatment, baseline PSR, and gender terms.|ANOVA|||Ibuprofen versus placebo at 1 hour.||1.94|1.11|<0.001
72472329|NCT01266161|144467848|SUPERIORITY||Least squares means|2.0|||<|0.001||95.0|1.56|2.44||p-Values from ANOVA model with treatment, baseline PSR, and gender terms.|ANOVA|||Ibuprofen versus placebo at 1.5 hours.||2.44|1.56|<0.001
72472330|NCT01266161|144467848|SUPERIORITY||Least squares means|2.29|||<|0.001||95.0|1.86|2.73||p-Values from ANOVA model with treatment, baseline PSR, and gender terms.|ANOVA|||Ibuprofen versus placebo at 2 hours.||2.73|1.86|<0.001
72472331|NCT01266161|144467848|SUPERIORITY||Least squares means|2.18|||<|0.001||95.0|1.69|2.68||p-Values from ANOVA model with treatment, baseline PSR, and gender terms.|ANOVA|||Ibuprofen versus placebo at 4 hours.||2.68|1.69|<0.001
72472332|NCT01266161|144467848|SUPERIORITY||Least squares means|0.92|||<|0.001||95.0|0.46|1.38||p-Values from ANOVA model with treatment, baseline PSR, and gender terms.|ANOVA||Treatment difference (ibuprofen minus placebo) and corresponding 95% CI were calculated based on least-squares means from the ANOVA model.|Ibuprofen versus placebo at 6 hours.||1.38|0.46|<0.001
72397775|NCT02801942|144301732|OTHER||Mean Difference (Final Values)|0.46|STANDARD_ERROR_OF_MEAN|1.304|||TWO_SIDED|95.0|-2.27|3.19|||||The mean difference in Reg T cells (Healthy participants versus NOT1D participants) by FNA method has been presented.|||3.19|-2.27|
72472333|NCT01266161|144467848|SUPERIORITY||Least squares means|1.04|||<|0.001||95.0|0.54|1.54||p-Values from ANOVA model with treatment, baseline PSR, and gender terms.|ANOVA|||Ibuprofen versus placebo at 8 hours.||1.54|0.54|<0.001
72472334|NCT01266161|144467848|SUPERIORITY||Least squares means|1.1|||<|0.001||95.0|0.59|1.6||p-Values from ANOVA model with treatment, baseline PSR, and gender terms.|ANOVA|||Ibuprofen versus placebo at 10 hours.||1.60|0.59|<0.001
72472335|NCT01266161|144467848|SUPERIORITY||Least squares means|0.5||||0.052||95.0|0.0|1.01||p-Values from ANOVA model with treatment, baseline PSR, and gender terms.|ANOVA|||Ibuprofen versus placebo at 12 hours.||1.01|-0.00|0.052
72472336|NCT01266161|144467849|SUPERIORITY||Least squares means|0.37|||<|0.001||95.0|0.16|0.59||p-Values from ANOVA model with treatment, baseline PSR, and gender terms.|ANOVA|||Ibuprofen versus placebo at 0.5 hours.||0.59|0.16|<0.001
72565799|NCT02709486|144662702|SUPERIORITY||Least Square Mean Difference|-0.79|STANDARD_ERROR_OF_MEAN|0.18|<|0.0001|TWO_SIDED|95.0|-1.14|-0.44|||ANCOVA|||Week 12: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.||-0.44|-1.14|<.0001
72472337|NCT01266161|144467849|SUPERIORITY||Least squares means|0.9|||<|0.001||95.0|0.63|1.18||p-Values from ANOVA model with treatment, baseline pain severity, and gender terms.|ANOVA|||Ibuprofen versus placebo at 1 hour.||1.18|0.63|<0.001
72472338|NCT01266161|144467849|SUPERIORITY||Least squares means|1.22|||<|0.001||95.0|0.91|1.52||p-Values from ANOVA model with treatment, baseline pain severity, and gender terms.|ANOVA|||Ibuprofen versus placebo at 1.5 hours.||1.52|0.91|<0.001
72472339|NCT01266161|144467849|SUPERIORITY||Least squares means|1.4|||<|0.001||95.0|1.1|1.71||p-Values from ANOVA model with treatment, baseline pain severity, and gender terms.|ANOVA|||Ibuprofen versus placebo at 2 hours.||1.71|1.10|<0.001
72472340|NCT01266161|144467849|SUPERIORITY||Least squares means|1.32|||<|0.001||95.0|0.97|1.67||p-Values from ANOVA model with treatment, baseline pain severity, and gender terms.|ANOVA|||Ibuprofen versus placebo at 4 hours.||1.67|0.97|<0.001
72472341|NCT01266161|144467849|SUPERIORITY||Least squares means|0.61|||<|0.001||95.0|0.3|0.91||p-Values from ANOVA model with treatment, baseline pain severity, and gender terms.|ANOVA|||Ibuprofen versus placebo at 6 hours.||0.91|0.30|<0.001
72472342|NCT01266161|144467849|SUPERIORITY||Least squares means|0.64|||<|0.001||95.0|0.31|0.97||p-Values from ANOVA model with treatment, baseline pain severity, and gender terms.|ANOVA|||Ibuprofen versus placebo at 8 hours.||0.97|0.31|<0.001
72472343|NCT01266161|144467849|SUPERIORITY||Least squares means|0.66|||<|0.001||95.0|0.36|0.97||p-Values from ANOVA model with treatment, baseline pain severity, and gender terms.|ANOVA|||Ibuprofen versus placebo at 10 hours.||0.97|0.36|<0.001
72472344|NCT01266161|144467849|SUPERIORITY||Least squares means|0.27||||0.089||95.0|-0.04|0.59||p-Values from ANOVA model with treatment, baseline pain severity, and gender terms.|ANOVA|||Ibuprofen versus placebo at 12 hours.||0.59|-0.04|0.089
72472345|NCT01266161|144467849|SUPERIORITY||Least squares means|1.0|||<|0.001||95.0|0.7|1.29||Ibuprofen versus placebo at 0.5 hours.|ANOVA|||Ibuprofen versus placebo at 16 hours.||1.29|0.70|<0.001
72472346|NCT01266161|144467849|SUPERIORITY||Least squares means|0.47||||0.004||95.0|0.15|0.78||p-Values from ANOVA model with treatment, baseline PSR, and gender terms.|ANOVA|||Ibuprofen versus placebo at 20 hours.||0.78|0.15|0.004
72472347|NCT01266161|144467849|SUPERIORITY||Least squares means|0.04||||0.821||95.0|-0.28|0.35||p-Values from ANOVA model with treatment, baseline PSR, and gender terms.|ANOVA|||Ibuprofen versus placebo at 24 hours.||0.35|-0.28|0.821
72397776|NCT02801942|144301732|OTHER||Mean Difference (Final Values)|-0.94|STANDARD_ERROR_OF_MEAN|1.056|||TWO_SIDED|95.0|-3.24|1.36|||||The mean difference in Reg T cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||1.36|-3.24|
72397777|NCT02801942|144301733|OTHER||Mean Difference (Final Values)|-1.16|STANDARD_ERROR_OF_MEAN|5.069|||TWO_SIDED|95.0|-11.91|9.58|||||The mean difference in CD69+ CD8 cells (Healthy participants versus NOT1D participants) by FNA method has been presented.|||9.58|-11.91|
72472348|NCT01266161|144467849|SUPERIORITY||Least squares means|0.56||||0.001||95.0|0.23|0.9||p-Values from ANOVA model with treatment, baseline PSR, and gender terms.|ANOVA|||Ibuprofen versus placebo at 28 hours.||0.90|0.23|0.001
72472349|NCT01266161|144467849|SUPERIORITY||Least squares means|0.62|||<|0.001||95.0|0.3|0.94||p-Values from ANOVA model with treatment, baseline PSR, and gender terms.|ANOVA|||Ibuprofen versus placebo at 32 hours.||0.94|0.30|<0.001
72472350|NCT01266161|144467849|SUPERIORITY||Least squares means|0.25||||0.127||95.0|-0.07|0.57||p-Values from ANOVA model with treatment, baseline PSR, and gender terms.|ANOVA|||Ibuprofen versus placebo at 36 hours.||0.57|-0.07|0.127
72472351|NCT01266161|144467849|SUPERIORITY||Least squares means|0.67|||<|0.001||95.0|0.35|1.0||p-Values from ANOVA model with treatment, baseline PSR, and gender terms.|ANOVA|||Ibuprofen versus placebo at 40 hours.||1.00|0.35|<0.001
72472352|NCT01266161|144467849|SUPERIORITY||Least squares means|0.34||||0.036||95.0|0.02|0.67||p-Values from ANOVA model with treatment, baseline PSR, and gender terms.|ANOVA|||Ibuprofen versus placebo at 44 hours.||0.67|0.02|0.036
72472353|NCT01266161|144467849|SUPERIORITY||Least squares means|0.26||||0.091||95.0|-0.04|0.56||p-Values from ANOVA model with treatment, baseline PSR, and gender terms.|ANOVA|||Ibuprofen versus placebo at 48 hours.||0.56|-0.04|0.091
72472354|NCT01266161|144467850|SUPERIORITY||Least squares means|1.22|||<|0.001||95.0|0.69|1.74||p-Values from ANOVA model with treatment, baseline PSR, and gender terms.|ANOVA|||Ibuprofen versus placebo at 0.5 hours.||1.74|0.69|<0.001
72472355|NCT01266161|144467850|SUPERIORITY||Least squares means|2.43|||<|0.001||95.0|1.77|3.09||p-Values from ANOVA model with treatment, baseline PSR, and gender terms.|ANOVA|||Ibuprofen versus placebo at 1 hour.||3.09|1.77|<0.001
72472356|NCT01266161|144467850|SUPERIORITY||Least squares means|3.22|||<|0.001||95.0|2.49|3.95||p-Values from ANOVA model with treatment, baseline PSR, and gender terms.|ANOVA|||Ibuprofen versus placebo at 1.5 hours.||3.95|2.49|<0.001
72472357|NCT01266161|144467850|SUPERIORITY||Least squares means|3.7|||<|0.001||95.0|2.98|4.42||p-Values from ANOVA model with treatment, baseline PSR, and gender terms.|ANOVA|||Ibuprofen versus placebo at 2 hours.||4.42|2.98|<0.001
72397778|NCT02801942|144301733|OTHER||Mean Difference (Final Values)|-4.38|STANDARD_ERROR_OF_MEAN|5.301|||TWO_SIDED|95.0|-15.85|7.1|||||The mean difference in CD69+ CD8 cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||7.10|-15.85|
72397779|NCT02801942|144301733|OTHER||Mean Difference (Final Values)|1.48|STANDARD_ERROR_OF_MEAN|1.374|||TWO_SIDED|95.0|-1.62|4.59|||||The mean difference in Ki67+ CD8 cells (Healthy participants versus NOT1D participants) by FNA method has been presented.|||4.59|-1.62|
72397780|NCT02801942|144301733|OTHER||Mean Difference (Final Values)|2.91|STANDARD_ERROR_OF_MEAN|1.291|||TWO_SIDED|95.0|-0.05|5.88|||||The mean difference in Ki67+ CD8 cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||5.88|-0.05|
72397781|NCT02801942|144301734|OTHER||Mean Difference (Final Values)|4.86|STANDARD_ERROR_OF_MEAN|3.083|||TWO_SIDED|95.0|-1.6|11.31|||||The mean difference in CD15s+ Reg T cells (Healthy participants versus NOT1D participants) by FNA method has been presented.|||11.31|-1.60|
72397782|NCT02801942|144301734|OTHER||Mean Difference (Final Values)|8.21|STANDARD_ERROR_OF_MEAN|6.78|||TWO_SIDED|95.0|-6.15|22.57|||||The mean difference in CD15s+ Reg T cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||22.57|-6.15|
72472358|NCT01266161|144467850|SUPERIORITY||Least squares means|3.5|||<|0.001||95.0|2.67|4.33||p-Values from ANOVA model with treatment, baseline PSR, and gender terms.|ANOVA|||Ibuprofen versus placebo at 4 hours.||4.33|2.67|<0.001
72472359|NCT01266161|144467850|SUPERIORITY||Least squares means|1.53|||<|0.001||95.0|0.79|2.27||p-Values from ANOVA model with treatment, baseline PSR, and gender terms.|ANOVA|||Ibuprofen versus placebo at 6 hours.||2.27|0.79|<0.001
72472360|NCT01266161|144467850|SUPERIORITY||Least squares means|1.67|||<|0.001||95.0|0.87|2.48||p-Values from ANOVA model with treatment, baseline PSR, and gender terms.|ANOVA|||Ibuprofen versus placebo at 8 hours.||2.48|0.87|<0.001
72472361|NCT01266161|144467850|SUPERIORITY||Least squares means|1.76|||<|0.001||95.0|0.97|2.54||p-Values from ANOVA model with treatment, baseline PSR, and gender terms.|ANOVA|||Ibuprofen versus placebo at 10 hours.||2.54|0.97|<0.001
72472362|NCT01266161|144467850|SUPERIORITY||Least squares means|0.78||||0.056||95.0|-0.02|1.58||p-Values from ANOVA model with treatment, baseline PSR, and gender terms.|ANOVA|||Ibuprofen versus placebo at 12 hours.||1.58|-0.02|0.056
72472363|NCT01266161|144467851|SUPERIORITY||Least squares means|14.82|||<|0.001|TWO_SIDED|95.0|10.38|19.25||p-Value from ANOVA model with treatment, baseline pain severity, and gender terms.|ANOVA|||Ibuprofen versus placebo at 0 to 12 hours.||19.25|10.38|<0.001
72472364|NCT01266161|144467851|SUPERIORITY||Least squares means|5.27|||<|0.001|TWO_SIDED|95.0|2.57|7.98||p-Value from ANOVA model with treatment, baseline pain severity, and gender terms.|ANOVA|||Ibuprofen versus placebo from 8 to 12 hours.||7.98|2.57|<0.001
72506621|NCT01899144|144545115|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|12.5|STANDARD_ERROR_OF_MEAN|4.85||0.0107|TWO_SIDED|95.0|2.93|22.05|||ANOVA|Mixed effect analysis of variance with fixed effects of sequence, treatment group, and period, and random effect for the patient within sequence|Active - Placebo|"The mean difference between each active group and placebo was tested in a sequential manner:~* Albuterol MDPI 180 mcg to placebo~* Albuterol MDPI 90 mcg to placebo~* ProAir HFA 180 mcg to placebo~* ProAir HFA 90 mcg to placebo Each test was 2 sided and done at the 0.05 level of significance. However, if a test was not significant at this level, no further tests were done. This sequential process assured that the overall alpha level for the entire series was not greater than 0.05."||22.05|2.93|0.0107
72506622|NCT01899144|144545115|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.4|STANDARD_ERROR_OF_MEAN|4.88||0.7772|TWO_SIDED|95.0|-11.0|8.23||0.05 level of significance|ANOVA||90 mcg - 180 mcg|Pre-specified, exploratory analysis||8.23|-11.00|0.7772
72472365|NCT01266161|144467852|SUPERIORITY||CMH-adjusted proportion|-0.73|||<|0.001|TWO_SIDED|95.0|-0.91|-0.55||p-Values from the CMH test with modified ridit scores, controlling for baseline PSR and gender.|Cochran-Mantel-Haenszel|||For the first dosing interval.||-0.55|-0.91|<0.001
72472366|NCT01266161|144467852|SUPERIORITY||CMH-adjusted proportions|-0.72|||<|0.001|TWO_SIDED|95.0|-1.05|-0.4||Treatment difference (ibuprofen minus placebo) and corresponding 95% CI were calculated based on CMH-adjusted proportions and corresponding standard errors.|Cochran-Mantel-Haenszel|||For the second dosing interval.||-0.40|-1.05|<0.001
72472367|NCT01266161|144467852|SUPERIORITY||CMH-adjusted proportions|-0.48||||0.002|TWO_SIDED|95.0|-0.9|-0.06||p-Values from the CMH test with modified ridit scores, controlling for baseline PSR and gender.|Cochran-Mantel-Haenszel|||For the third dosing interval.||-0.06|-0.90|0.002
72472368|NCT01266161|144467852|SUPERIORITY||CMH-adjusted proportion|-0.68||||0.021|TWO_SIDED|95.0|-1.02|-0.35||p-Values from the CMH test with modified ridit scores, controlling for baseline PSR and gender.|Cochran-Mantel-Haenszel|||For the fourth dosing interval.||-0.35|-1.02|0.021
72472369|NCT01266161|144467852|SUPERIORITY||CMH-adjusted proportion|-0.7|||<|0.001|TWO_SIDED|95.0|-0.89|-0.51||p-Values from the CMH test with modified ridit scores, controlling for baseline PSR and gender.|Cochran-Mantel-Haenszel|||For the overall study duration.||-0.51|-0.89|<0.001
72472370|NCT01266161|144467855|SUPERIORITY||Gamma statistic|0.85|||<|0.001|TWO_SIDED|95.0|0.74|0.95||p-Value from the CMH test with modified ridit scores, controlling for baseline PSR score and gender.|Cochran-Mantel-Haenszel|||Ibuprofen versus placebo at 24 hours||0.95|0.74|<0.001
72472371|NCT01266161|144467855|SUPERIORITY||Gamma statistic|0.79|||<|0.001|TWO_SIDED|95.0|0.66|0.92|||Cochran-Mantel-Haenszel|p-Value from the CMH test with modified ridit scores, controlling for baseline PSR score and gender.||Ibuprofen versus placebo at 48 hours||0.92|0.66|<0.001
72472372|NCT02567708|144467895|OTHER||Posterior median difference.|0.007|STANDARD_DEVIATION|0.0468||0.57|TWO_SIDED|95.0|-0.083|0.102||The data entered for the p-value represents the posterior probability that the true treatment difference is greater than zero.|Bayesian repeated measures model.|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted.|The data entered as the 95% confidence interval represents the 95% equi-tailed credible interval. The posterior median difference is calculated as GSK2269557 1000 μg minus Placebo.|||0.102|-0.083|0.57
72472373|NCT02567708|144467896|OTHER||Posterior median difference.|0.013|STANDARD_DEVIATION|0.0501||0.61|TWO_SIDED|95.0|-0.084|0.113||The data entered for the p-value represents the posterior probability that the true treatment difference is greater than zero.|Bayesian repeated measures model.|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted.|The data entered as the 95% confidence interval represents the 95% equi-tailed credible interval. The posterior median difference is calculated as GSK2269557 1000 μg minus Placebo.|||0.113|-0.084|0.61
72472374|NCT02567708|144467897|OTHER|The data entered for the p-value represents the posterior probability that the true treatment difference is greater than zero.|Posterior median difference|0.05|STANDARD_DEVIATION|0.0818||0.731|TWO_SIDED|95.0|-0.111|0.21|||Bayesian model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted.|The data entered as the 95% confidence interval represents the 95% equi-tailed credible interval. The posterior median difference is calculated as GSK2269557 1000 μg minus Placebo.|||0.210|-0.111|0.731
72472375|NCT02567708|144467898|OTHER||Posterior median difference|-0.009|STANDARD_DEVIATION|0.0712||0.44|TWO_SIDED|95.0|-0.151|0.131||The data entered for the p-value represents the posterior probability that the true treatment difference is greater than zero.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted.|Day 7. The data entered as the 95% confidence interval represents the 95% equi-tailed credible interval. The posterior median difference is calculated as GSK2269557 1000 μg minus Placebo.|||0.131|-0.151|0.44
72472376|NCT02567708|144467898|OTHER||Posterior median difference|0.024|STANDARD_DEVIATION|0.057||0.66|TWO_SIDED|95.0|-0.087|0.137||The data entered for the p-value represents the posterior probability that the true treatment difference is greater than zero.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted.|Day 14. The data entered as the 95% confidence interval represents the 95% equi-tailed credible interval. The posterior median difference is calculated as GSK2269557 1000 μg minus Placebo.|||0.137|-0.087|0.66
72472377|NCT02567708|144467899|OTHER||Posterior median difference|-0.021|STANDARD_DEVIATION|0.0609||0.35|TWO_SIDED|95.0|-0.14|0.099||The data entered for the p-value represents the posterior probability that the true treatment difference is greater than zero.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted.|Day 7. The data entered as the 95% confidence interval represents the 95% equi-tailed credible interval. The posterior median difference is calculated as GSK2269557 1000 μg minus Placebo.|||0.099|-0.140|0.35
72565800|NCT02709486|144662702|SUPERIORITY||Least Square Mean Difference|-0.62|STANDARD_ERROR_OF_MEAN|0.18||0.0006|TWO_SIDED|95.0|-0.98|-0.27|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.||-0.27|-0.98|0.0006
72472378|NCT02567708|144467899|OTHER||Posterior median difference|0.04|STANDARD_DEVIATION|0.0578||0.76|TWO_SIDED|95.0|-0.071|0.156||The data entered for the p-value represents the posterior probability that the true treatment difference is greater than zero.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted.|Day 14. The data entered as the 95% confidence interval represents the 95% equi-tailed credible interval. The posterior median difference is calculated as GSK2269557 1000 μg minus Placebo.|||0.156|-0.071|0.76
72472379|NCT02567708|144467899|OTHER||Posterior median difference|0.038|STANDARD_DEVIATION|0.0559||0.76|TWO_SIDED|95.0|-0.073|0.148||The data entered for the p-value represents the posterior probability that the true treatment difference is greater than zero.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted.|Day 28. The data entered as the 95% confidence interval represents the 95% equi-tailed credible interval. The posterior median difference is calculated as GSK2269557 1000 μg minus Placebo.|||0.148|-0.073|0.76
72506623|NCT01899144|144545115|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-11.2|STANDARD_ERROR_OF_MEAN|4.87||0.0226|TWO_SIDED|95.0|-20.8|-1.59||0.05 level of significance|ANOVA||90 mcg - 180 mcg|Pre-specified, exploratory analysis||-1.59|-20.80|0.0226
72397783|NCT02801942|144301734|OTHER||Mean Difference (Final Values)|-11.19|STANDARD_ERROR_OF_MEAN|5.812|||TWO_SIDED|95.0|-23.48|1.11|||||The mean difference in CD69+ Reg T cells (Healthy participants versus NOT1D participants) by FNA method has been presented.|||1.11|-23.48|
72472380|NCT02567708|144467900|OTHER||Posterior median difference|0.083|STANDARD_DEVIATION|0.6175||0.56|TWO_SIDED|95.0|-1.102|1.346||The data entered for the p-value represents the posterior probability that the true treatment difference is greater than zero.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted.|Day 7. The data entered as the 95% confidence interval represents the 95% equi-tailed credible interval. The posterior median difference is calculated as GSK2269557 1000 μg minus Placebo.|||1.346|-1.102|0.56
72472381|NCT02567708|144467900|OTHER||Posterior median difference|0.014|STANDARD_DEVIATION|0.6672||0.51|TWO_SIDED|95.0|-1.271|1.341||The data entered for the p-value represents the posterior probability that the true treatment difference is greater than zero.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted.|Day 14. The data entered as the 95% confidence interval represents the 95% equi-tailed credible interval. The posterior median difference is calculated as GSK2269557 1000 μg minus Placebo.|||1.341|-1.271|0.51
72472382|NCT02567708|144467900|OTHER||Posterior median difference|-0.113|STANDARD_DEVIATION|0.5148||0.41|TWO_SIDED|95.0|-1.125|0.908||The data entered for the p-value represents the posterior probability that the true treatment difference is greater than zero.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted.|Day 28. The data entered as the 95% confidence interval represents the 95% equi-tailed credible interval. The posterior median difference is calculated as GSK2269557 1000 μg minus Placebo..|||0.908|-1.125|0.41
72472383|NCT02567708|144467901|OTHER||Posterior median difference|0.5|STANDARD_DEVIATION|0.59||0.81|TWO_SIDED|95.0|-0.6|1.7||The data entered for the p-value represents the posterior probability that the true treatment difference is greater than zero.|Bayesian model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted.|The data entered as the 95% confidence interval represents the 95% equi-tailed credible interval. The posterior median difference is calculated as GSK2269557 1000 μg minus Placebo.|||1.7|-0.6|0.81
72472384|NCT02567708|144467904|OTHER||Posterior median ratio|0.89|STANDARD_DEVIATION|0.063||0.97|TWO_SIDED|95.0|0.78|1.0||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted.|Day 7. The data entered as the 95% confidence interval represents the 95% equi-tailed credible interval. The posterior median ratio is calculated as GSK2269557 1000 μg/ Placebo.|||1.00|0.78|0.97
72472385|NCT02567708|144467904|OTHER||Posterior median ratio|0.95|STANDARD_DEVIATION|0.071||0.76|TWO_SIDED|95.0|0.83|1.09||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted.|Day 14. The data entered as the 95% confidence interval represents the 95% equi-tailed credible interval. The posterior median ratio is calculated as GSK2269557 1000 μg/ Placebo.|||1.09|0.83|0.76
72472386|NCT02567708|144467904|OTHER||Posterior median ratio|1.0|STANDARD_DEVIATION|0.085||0.51|TWO_SIDED|95.0|0.84|1.18||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than one.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted.|Day 28. The data entered as the 95% confidence interval represents the 95% equi-tailed credible interval. The posterior median ratio is calculated as GSK2269557 1000 μg/ Placebo.|||1.18|0.84|0.51
72472387|NCT05262751|144467922|OTHER||gMean Ratio|16.69|||||TWO_SIDED|90.0|7.28|38.24|||||gMean Ratio: MR1-1/R. Intra-individual Geometric coefficient of variation \[%\] = 34.1|Analysis of Variance (ANOVA) model (logarithmic scale) with the effects: sequence, subjects within sequences, period, and treatment. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||38.24|7.28|
72472388|NCT05262751|144467922|OTHER||gMean Ratio|13.54|||||TWO_SIDED|90.0|8.1|22.64|||||gMean Ratio: MR1-2/R. Intra-individual Geometric coefficient of variation \[%\] = 34.1|Analysis of Variance (ANOVA) model (logarithmic scale) with the effects: sequence, subjects within sequences, period, and treatment. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||22.64|8.10|
72472389|NCT05262751|144467922|OTHER||gMean Ratio|41.8|||||TWO_SIDED|90.0|34.24|51.04|||||gMean Ratio: MR2-1/R. Intra-individual Geometric coefficient of variation \[%\] = 28.4|Analysis of Variance (ANOVA) model (logarithmic scale) with the effects: sequence, subjects within sequences, period, and treatment. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||51.04|34.24|
72472390|NCT05262751|144467922|OTHER||gMean Ratio|42.91|||||TWO_SIDED|90.0|34.9|52.76|||||gMean Ratio: MR2-2/R. Intra-individual Geometric coefficient of variation \[%\] = 28.4|Analysis of Variance (ANOVA) model (logarithmic scale) with the effects: sequence, subjects within sequences, period, and treatment. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||52.76|34.90|
72397784|NCT02801942|144301734|OTHER||Mean Difference (Final Values)|-5.89|STANDARD_ERROR_OF_MEAN|3.855|||TWO_SIDED|95.0|-14.14|2.37|||||The mean difference in CD69+ Reg T cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||2.37|-14.14|
72472391|NCT05262751|144467923|OTHER||gMean Ratio|9.36|||||TWO_SIDED|90.0|5.91|14.8|||||gMean Ratio: MR1-1/R. Intra-individual Geometric coefficient of variation \[%\] = 44.8|Analysis of Variance (ANOVA) model (logarithmic scale) with the effects: sequence, subjects within sequences, period, and treatment. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||14.80|5.91|
72565801|NCT02709486|144662702|SUPERIORITY||Least Square Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.18||0.0009|TWO_SIDED|95.0|-0.96|-0.25|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.||-0.25|-0.96|0.0009
72397785|NCT02801942|144301734|OTHER||Mean Difference (Final Values)|1.65|STANDARD_ERROR_OF_MEAN|2.48|||TWO_SIDED|95.0|-3.54|6.84|||||The mean difference in Helios+ Reg T cells (Healthy participants versus NOT1D participants) by FNA method has been presented.|||6.84|-3.54|
72397786|NCT02801942|144301734|OTHER||Mean Difference (Final Values)|2.57|STANDARD_ERROR_OF_MEAN|2.937|||TWO_SIDED|95.0|-3.84|8.98|||||The mean difference in Helios+ Reg T cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||8.98|-3.84|
72397787|NCT02801942|144301734|OTHER||Mean Difference (Final Values)|3.22|STANDARD_ERROR_OF_MEAN|2.781|||TWO_SIDED|95.0|-2.67|9.12|||||The mean difference in Ki67+ T Reg cells (Healthy participants versus NOT1D participants) by FNA method has been presented.|||9.12|-2.67|
72397788|NCT02801942|144301734|OTHER||Mean Difference (Final Values)|3.38|STANDARD_ERROR_OF_MEAN|1.337|||TWO_SIDED|95.0|0.55|6.21|||||The mean difference in Ki67+ T Reg cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||6.21|0.55|
72397789|NCT02801942|144301734|OTHER||Mean Difference (Final Values)|-1.45|STANDARD_ERROR_OF_MEAN|4.736|||TWO_SIDED|95.0|-11.49|8.58|||||The mean difference in Memory Reg T cells (Healthy participants versus NOT1D participants) by FNA method has been presented.|||8.58|-11.49|
72397790|NCT02801942|144301734|OTHER||Mean Difference (Final Values)|1.88|STANDARD_ERROR_OF_MEAN|4.142|||TWO_SIDED|95.0|-6.81|10.58|||||The mean difference in Memory Reg T cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||10.58|-6.81|
72397791|NCT02801942|144301734|OTHER||Mean Difference (Final Values)|10.45|STANDARD_ERROR_OF_MEAN|5.79|||TWO_SIDED|95.0|-2.01|22.92|||||The mean difference in Resting Reg T cells (Healthy participants versus NOT1D participants) by FNA method has been presented.|||22.92|-2.01|
72565802|NCT02709486|144662702|SUPERIORITY||Least Square Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.19||0.0377|TWO_SIDED|95.0|-0.78|-0.02|||ANCOVA|||Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.||-0.02|-0.78|0.0377
72397792|NCT02801942|144301734|OTHER||Mean Difference (Final Values)|6.17|STANDARD_ERROR_OF_MEAN|4.913|||TWO_SIDED|95.0|-4.24|16.59|||||The mean difference in Resting Reg T cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||16.59|-4.24|
72397793|NCT02801942|144301735|OTHER||Mean Difference (Final Values)|1.38|STANDARD_ERROR_OF_MEAN|0.696|||TWO_SIDED|95.0|-0.08|2.83|||||The mean difference in CD15s+ Conv T cells (Healthy participants versus NOT1D participants) by FNA method has been presented.|||2.83|-0.08|
72397794|NCT02801942|144301735|OTHER||Mean Difference (Final Values)|2.19|STANDARD_ERROR_OF_MEAN|1.324|||TWO_SIDED|95.0|-0.61|4.98|||||The mean difference in CD15s+ Conv T cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||4.98|-0.61|
72397795|NCT02801942|144301735|OTHER||Mean Difference (Final Values)|-0.91|STANDARD_ERROR_OF_MEAN|6.389|||TWO_SIDED|95.0|-14.66|12.85|||||The mean difference in CD69+ Conv T cells (Healthy participants versus NOT1D participants) by FNA method has been presented.|||12.85|-14.66|
72397796|NCT02801942|144301735|OTHER||Mean Difference (Final Values)|-4.19|STANDARD_ERROR_OF_MEAN|4.862|||TWO_SIDED|95.0|-14.71|6.33|||||The mean difference in CD69+ Conv T cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||6.33|-14.71|
72397797|NCT02801942|144301735|OTHER||Mean Difference (Final Values)|-0.13|STANDARD_ERROR_OF_MEAN|1.234|||TWO_SIDED|95.0|-2.73|2.47|||||The mean difference in Helios+ Conv T cells (Healthy participants versus NOT1D participants) by FNA method has been presented.|||2.47|-2.73|
72397798|NCT02801942|144301735|OTHER||Mean Difference (Final Values)|0.41|STANDARD_ERROR_OF_MEAN|0.859|||TWO_SIDED|95.0|-1.45|2.28|||||The mean difference in Helios+ Conv T cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||2.28|-1.45|
72397799|NCT02801942|144301735|OTHER||Mean Difference (Final Values)|3.21|STANDARD_ERROR_OF_MEAN|1.205|||TWO_SIDED|95.0|0.64|5.78|||||The mean difference in Ki67+ Conv T cells (Healthy participants versus NOT1D participants) by FNA method has been presented.|||5.78|0.64|
72397800|NCT02801942|144301735|OTHER||Mean Difference (Final Values)|2.27|STANDARD_ERROR_OF_MEAN|0.712|||TWO_SIDED|95.0|0.75|3.79|||||The mean difference in Ki67+ Conv T cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||3.79|0.75|
72397801|NCT02801942|144301736|OTHER||Mean Difference (Final Values)|3.27|STANDARD_ERROR_OF_MEAN|1.37|||TWO_SIDED|95.0|0.4|6.15|||||The mean difference in CD15s+ Memory Conv T cells (Healthy participants versus NOT1D participants) by FNA method has been presented.|||6.15|0.40|
72397802|NCT02801942|144301736|OTHER||Mean Difference (Final Values)|2.74|STANDARD_ERROR_OF_MEAN|2.109|||TWO_SIDED|95.0|-1.68|7.17|||||The mean difference in CD15s+ Memory Conv T cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||7.17|-1.68|
72397803|NCT02801942|144301736|OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|6.712|||TWO_SIDED|95.0|-14.49|14.48|||||The mean difference in CD69+ Memory Conv T cells (Healthy participants versus NOT1D participants) by FNA method has been presented.|||14.48|-14.49|
72397804|NCT02801942|144301736|OTHER||Mean Difference (Final Values)|-4.12|STANDARD_ERROR_OF_MEAN|3.947|||TWO_SIDED|95.0|-12.67|4.43|||||The mean difference in CD69+ Memory Conv T cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||4.43|-12.67|
72397805|NCT02801942|144301736|OTHER||Mean Difference (Final Values)|1.33|STANDARD_ERROR_OF_MEAN|2.967|||TWO_SIDED|95.0|-5.48|8.13|||||The mean difference in Helios+ Memory Conv T cells (Healthy participants versus NOT1D participants) by FNA method has been presented.|||8.13|-5.48|
72397806|NCT02801942|144301736|OTHER||Mean Difference (Final Values)|1.24|STANDARD_ERROR_OF_MEAN|2.287|||TWO_SIDED|95.0|-4.36|6.84|||||The mean difference in Helios+ Memory Conv T cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||6.84|-4.36|
72397807|NCT02801942|144301736|OTHER||Mean Difference (Final Values)|2.69|STANDARD_ERROR_OF_MEAN|1.019|||TWO_SIDED|95.0|0.54|4.84|||||The mean difference in Ki67+ Memory Conv T cells (Healthy participants versus NOT1D participants) by FNA method has been presented.|||4.84|0.54|
72397808|NCT02801942|144301736|OTHER||Mean Difference (Final Values)|1.58|STANDARD_ERROR_OF_MEAN|0.737|||TWO_SIDED|95.0|0.03|3.13|||||The mean difference in Ki67+ Memory Conv T cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||3.13|0.03|
72397809|NCT03182829|144301769|NON_INFERIORITY|non-inferiority was chosen|Mean Difference (Final Values)|100.0|||<|0.05|TWO_SIDED|95.0|90.0|100.0|||Chi-squared||||Fisher's exact test|100|90|<0.05
72397810|NCT00254540|144301770|SUPERIORITY_OR_OTHER||Objective Response Rate(percentage)|48.0||||||95.0|27.8|68.7||||||||68.7|27.8|
72397811|NCT00254540|144301770|SUPERIORITY_OR_OTHER||Objective Response Rate(percentage)|46.2||||||95.0|26.6|66.6||||||||66.6|26.6|
72397812|NCT00225251|144301786|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.0|||<|0.05|||||||t-test, 2 sided|||||||<.05
72397813|NCT01313767|144301803|NON_INFERIORITY_OR_EQUIVALENCE|90% of the power, 0.45 of non-inferiority margin|Mean Difference (Final Values)|0.17||||0.1347|TWO_SIDED|95.0|-0.05|0.4|||t-test, 2 sided|||The difference between the two groups was provided with 95% CI. If the upper limit of CI is no greater than 0.45 (non-inferiority margin), the study group was determined not inferior to the control group. Additionally, difference between groups in change from baseline to week 4 in wrist flexor MAS score was compared using two sample t-test.||0.40|-0.05|0.1347
72565803|NCT02709486|144662702|SUPERIORITY||Least Square Mean Difference|-0.59|STANDARD_ERROR_OF_MEAN|0.19||0.0019|TWO_SIDED|95.0|-0.96|-0.22|||ANCOVA|||Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.||-0.22|-0.96|0.0019
72397814|NCT01313767|144301804|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.07||||0.2591|TWO_SIDED||||||t-test, 2 sided|||Difference between groups in change from baseline to week 8 in wrist flexor MAS score was compared using two sample t-test.||||0.2591
72397815|NCT01313767|144301804|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.09||||0.3395|TWO_SIDED||||||t-test, 2 sided|||Difference between groups in change from baseline to week 12 in wrist flexor MAS score was compared using two sample t-test.||||0.3395
72397816|NCT01313767|144301805|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2||||0.0675|TWO_SIDED||||||t-test, 2 sided|||Difference between groups in change from baseline to week 4 in elbow flexor MAS score was compared using two sample t-test.||||0.0675
72397817|NCT01313767|144301805|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2||||0.0605|TWO_SIDED||||||t-test, 2 sided|||Difference between groups in change from baseline to week 8 in elbow flexor MAS score was compared using two sample t-test.||||0.0605
72397818|NCT01313767|144301805|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.23||||0.0429|TWO_SIDED||||||t-test, 2 sided|||Difference between groups in change from baseline to week 12 in elbow flexor MAS score was compared using two sample t-test.||||0.0429
72397819|NCT01313767|144301806|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.06||||0.6954|TWO_SIDED||||||t-test, 2 sided|||Difference between groups in change from baseline to week 4 in finger flexor MAS score was compared using two sample t-test.||||0.6954
72397820|NCT01313767|144301806|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.07||||0.6024|TWO_SIDED||||||t-test, 2 sided|||Difference between groups in change from baseline to week 8 in finger flexor MAS score was compared using two sample t-test.||||0.6024
72623025|NCT01299961|144776386|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.4|STANDARD_DEVIATION|13.1|<|0.01|TWO_SIDED||||||t-test, 2 sided|||Most involved side: Synovitis (S), tenosynovitis (T), and power Doppler (PD) of wrist (dorsal (D), palmar (P), and ulnar (U)); S and T of MCP 2,3 (P, plus D for T); PD of the MCP joints (P and D); S and PD of PIP 2, 3 (P, plus D for PD); S and PD for MTP 2, 4 (D). S and PD graded from 0 to 3, and max individual scores are 27 and 39, respectively. T graded on 0-1 scale; max T score is 5. High score is worse. The 7-joint US score is sum of T, S, and PD scores. Change calculated baseline- month 12.||||<0.01
72397821|NCT01313767|144301806|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02||||0.9316|TWO_SIDED||||||t-test, 2 sided|||Difference between groups in change from baseline to week 12 in finger flexor MAS score was compared using two sample t-test.||||0.9316
72397822|NCT01313767|144301807|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.19||||0.2284|TWO_SIDED||||||t-test, 2 sided|||Difference between groups in change from baseline to week 4 in thumb flexor MAS score was compared using two sample t-test.||||0.2284
72397823|NCT01313767|144301807|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.15||||0.3221|TWO_SIDED||||||t-test, 2 sided|||Difference between groups in change from baseline to week 8 in thumb flexor MAS score was compared using two sample t-test.||||0.3221
72397824|NCT01313767|144301807|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.09||||0.593|TWO_SIDED||||||t-test, 2 sided|||Difference between groups in change from baseline to week 12 in thumb flexor MAS score was compared using two sample t-test.||||0.5930
72397825|NCT01313767|144301808|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.07||||0.1585|TWO_SIDED||||||Chi-squared|||Difference between groups in frequency of responders who have improved at least 1-point on the MAS at week 4 from baseline in wrist flexor was compared using Pearson's chi-square test.||||0.1585
72397826|NCT01313767|144301808|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.0028||||0.9596|TWO_SIDED||||||Chi-squared|||Difference between groups in frequency of responders who have improved at least 1-point on the MAS at week 8 from baseline in wrist flexor was compared using Pearson's chi-square test.||||0.9596
72397827|NCT01313767|144301808|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.0304||||0.6164|TWO_SIDED||||||Chi-squared|||Difference between groups in frequency of responders who have improved at least 1-point on the MAS at week 12 from baseline in wrist flexor was compared using Pearson's chi-square test.||||0.6164
72397828|NCT01313767|144301809|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.098||||0.1802|TWO_SIDED||||||Chi-squared|||Difference between groups in frequency of responders who have improved at least 1-point on the MAS at week 4 from baseline in elbow flexor was compared using Pearson's chi-square test.||||0.1802
72397829|NCT01313767|144301809|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.1164||||0.1176|TWO_SIDED||||||Chi-squared|||Difference between groups in frequency of responders who have improved at least 1-point on the MAS at week 8 from baseline in elbow flexor was compared using Pearson's chi-square test.||||0.1176
72397830|NCT01313767|144301809|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.1138||||0.1252|TWO_SIDED||||||Chi-squared|||Difference between groups in frequency of responders who have improved at least 1-point on the MAS at week 12 from baseline in elbow flexor was compared using Pearson's chi-square test.||||0.1252
72397831|NCT01313767|144301810|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.098||||0.3431|TWO_SIDED||||||Chi-squared|||Difference between groups in frequency of responders who have improved at least 1-point on the MAS at week 4 from baseline in finger flexor was compared using Pearson's chi-square test.||||0.3431
72472392|NCT05262751|144467923|OTHER||gMean Ratio|12.41|||||TWO_SIDED|90.0|7.93|19.43|||||gMean Ratio: MR1-2/R. Intra-individual Geometric coefficient of variation \[%\] = 44.8|Analysis of Variance (ANOVA) model (logarithmic scale) with the effects: sequence, subjects within sequences, period, and treatment. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||19.43|7.93|
72472393|NCT05262751|144467923|OTHER||gMean Ratio|37.9|||||TWO_SIDED|90.0|29.25|49.11|||||gMean Ratio: MR2-1/R. Intra-individual Geometric coefficient of variation \[%\] = 40.4|Analysis of Variance (ANOVA) model (logarithmic scale) with the effects: sequence, subjects within sequences, period, and treatment. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||49.11|29.25|
72472394|NCT05262751|144467923|OTHER||gMean Ratio|35.89|||||TWO_SIDED|90.0|27.66|46.55|||||gMean ratio: MR2-2/R. Intra-individual Geometric coefficient of variation \[%\] = 40.4|Analysis of Variance (ANOVA) model (logarithmic scale) with the effects: sequence, subjects within sequences, period, and treatment. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||46.55|27.66|
72472395|NCT05262751|144467924|OTHER||gMean Ratio|12.09|||||TWO_SIDED|90.0|6.73|21.71|||||gMean Ratio: MR1-1/R. Intra-individual Geometric coefficient of variation \[%\] = 58.8|Analysis of Variance (ANOVA) model (logarithmic scale) with the effects: sequence, subjects within sequences, period, and treatment. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||21.71|6.73|
72472396|NCT05262751|144467924|OTHER||gMean Ratio|23.94|||||TWO_SIDED|90.0|13.51|42.42|||||gMean Ratio: MR1-2/R. Intra-individual Geometric coefficient of variation \[%\] = 58.8|Analysis of Variance (ANOVA) model (logarithmic scale) with the effects: sequence, subjects within sequences, period, and treatment. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||42.42|13.51|
72472397|NCT05262751|144467924|OTHER||gMean Ratio|68.55|||||TWO_SIDED|90.0|50.07|93.86|||||gMean ratio: MR2-1/R. Intra-individual Geometric coefficient of variation \[%\] = 50.0|Analysis of Variance (ANOVA) model (logarithmic scale) with the effects: sequence, subjects within sequences, period, and treatment. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||93.86|50.07|
72472398|NCT05262751|144467924|OTHER||gMean Ratio|66.85|||||TWO_SIDED|90.0|48.77|91.64|||||gMean ratio: MR2-2/R. Intra-individual Geometric coefficient of variation \[%\] = 50.0|Analysis of Variance (ANOVA) model (logarithmic scale) with the effects: sequence, subjects within sequences, period, and treatment. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||91.64|48.77|
72472399|NCT05262751|144467925|OTHER||gMean Ratio|11.96|||||TWO_SIDED|90.0|8.88|16.11|||||gMean ratio: MR1-1/R. Intra-individual Geometric coefficient of variation \[%\] = 23.5|Analysis of Variance (ANOVA) model (logarithmic scale) with the effects: sequence, subjects within sequences, period, and treatment. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||16.11|8.88|
72472400|NCT05262751|144467925|OTHER||gMean Ratio|13.98|||||TWO_SIDED|90.0|10.59|18.46|||||gMean ratio: MR1-2/R. Intra-individual Geometric coefficient of variation \[%\] = 23.5|Analysis of Variance (ANOVA) model (logarithmic scale) with the effects: sequence, subjects within sequences, period, and treatment. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||18.46|10.59|
72472401|NCT05262751|144467925|OTHER||gMean Ratio|32.13|||||TWO_SIDED|90.0|26.46|39.01|||||gMean ratio: MR2-1/R. Intra-individual Geometric coefficient of variation \[%\] = 29.3.|Analysis of Variance (ANOVA) model (logarithmic scale) with the effects: sequence, subjects within sequences, period, and treatment. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||39.01|26.46|
72472402|NCT05262751|144467925|OTHER||gMean Ratio|31.38|||||TWO_SIDED|90.0|25.71|38.3|||||gMean ratio: MR2-2/R. Intra-individual Geometric coefficient of variation \[%\] = 29.3.|Analysis of Variance (ANOVA) model (logarithmic scale) with the effects: sequence, subjects within sequences, period, and treatment. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||38.30|25.71|
72472403|NCT01154140|144467926|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.454|||<|0.0001|TWO_SIDED|95.0|0.346|0.596||P-value was obtained from 1-sided log rank test, stratified by eastern cooperative oncology group performance status (ECOG PS),race,brain metastases. 1-sided log-rank test at 0.0247 level of significance was used to compare PFS between the 2 arms.|Log Rank|||||0.596|0.346|<0.0001
72472404|NCT01154140|144467927|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.76||||0.0489|TWO_SIDED|95.0|0.548|1.053||P-value was obtained from 1-sided log rank test, stratified by ECOG PS, race group and brain metastases.|Log Rank||HR was calculated based on the Cox Proportional hazards model stratified by ECOG PS, race group, and brain metastases. Assuming proportional hazards, a hazard ratio (less than)\<1 indicates a reduction in hazard rate in favor of crizotinib.|||1.053|0.548|0.0489
72506624|NCT01899144|144545116|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.45|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001|TWO_SIDED|95.0|0.26|0.64|||ANOVA|Mixed effect analysis of variance with fixed effects of sequence, treatment group, and period, and random effect for the patient within sequence|Active - Placebo|"The mean difference between each active group and placebo was tested in a sequential manner:~* Albuterol MDPI 180 mcg to placebo~* Albuterol MDPI 90 mcg to placebo~* ProAir HFA 180 mcg to placebo~* ProAir HFA 90 mcg to placebo Each test was 2 sided and done at the 0.05 level of significance. However, if a test was not significant at this level, no further tests were done. This sequential process assured that the overall alpha level for the entire series was not greater than 0.05."||0.64|0.26|<0.0001
72506625|NCT01899144|144545116|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.4|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001|TWO_SIDED|95.0|0.21|0.59|||ANOVA|Mixed effect analysis of variance with fixed effects of sequence, treatment group, and period, and random effect for the patient within sequence|Active - Placebo|"The mean difference between each active group and placebo was tested in a sequential manner:~* Albuterol MDPI 180 mcg to placebo~* Albuterol MDPI 90 mcg to placebo~* ProAir HFA 180 mcg to placebo~* ProAir HFA 90 mcg to placebo Each test was 2 sided and done at the 0.05 level of significance. However, if a test was not significant at this level, no further tests were done. This sequential process assured that the overall alpha level for the entire series was not greater than 0.05."||0.59|0.21|<0.0001
72472405|NCT01154140|144467929|SUPERIORITY_OR_OTHER||Difference in Percentage|29.4|||<|0.0001|TWO_SIDED|95.0|19.5|39.3||P-value was obtained from a Pearson chi-square test.|Pearson chi-square test||95% CI was calculated based on normal distribution.|If the PFS endpoint was significant, ORR was to be considered significant if the 2-sided p-value from Pearson chi-square test was (less than or equal to)\<= 0.0494.||39.3|19.5|<0.0001
72397832|NCT01313767|144301810|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.1097||||0.1329|TWO_SIDED||||||Chi-squared|||Difference between groups in frequency of responders who have improved at least 1-point on the MAS at week 8 from baseline in finger flexor was compared using Pearson's chi-square test||||0.1329
72397833|NCT01313767|144301810|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.0853||||0.2611|TWO_SIDED||||||Chi-squared|||Difference between groups in frequency of responders who have improved at least 1-point on the MAS at week 12 from baseline in finger flexor was compared using Pearson's chi-square test||||0.2611
72397834|NCT01313767|144301811|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.0654||||0.4623|TWO_SIDED||||||Chi-squared|||Difference between groups in frequency of responders who have improved at least 1-point on the MAS at week 4 from baseline in thumb flexor was compared using Pearson's chi-square test.||||0.4623
72397835|NCT01313767|144301811|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.1194||||0.2007|TWO_SIDED||||||Chi-squared|||Difference between groups in frequency of responders who have improved at least 1-point on the MAS at week 8 from baseline in thumb flexor was compared using Pearson's chi-square test.||||0.2007
72472406|NCT01154140|144467932|SUPERIORITY_OR_OTHER||Difference in Percentage|10.067||||0.0381|TWO_SIDED|95.0|0.8|19.4|||Pearson chi-square test|||The confidence interval for the difference in percentage was based on normal distribution.||19.4|0.8|0.0381
72472407|NCT01154140|144467933|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.441|||<|0.0001|TWO_SIDED|95.0|0.335|0.582||P-value was obtained from 1-sided unstratified log-rank test.|Log Rank|||Analysis was based on the Cox Proportional hazards model assuming proportional hazards, a HR \<1 indicated a reduction in hazard rate in favor of Crizotinib.||0.582|0.335|<0.0001
72472408|NCT01154140|144467934|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.595||||0.0347|TWO_SIDED|95.0|0.338|1.048||P-value was obtained from 1-sided unstratified log-rank test.|Log Rank|||Analysis was based on the Cox Proportional hazards model assuming proportional hazards, a HR less than 1 indicated a reduction in hazard rate in favor of Crizotinib.||1.048|0.338|0.0347
72472409|NCT01154140|144467935|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.387|||<|0.0001|TWO_SIDED|95.0|0.286|0.524||P-value was obtained from 1-sided unstratified log-rank test.|Log Rank|||Analysis was based on the Cox Proportional hazards model assuming proportional hazards, a HR less than 1 indicated a reduction in hazard rate in favor of Crizotinib.||0.524|0.286|<0.0001
72472410|NCT01154140|144467942|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.591||||0.0002|TWO_SIDED|95.0|0.452|0.773||Two-sided p-value from the unstratified log rank test was used.|Log Rank|||HR was calculated based on the Cox Proportional hazards model. Assuming proportional hazards, a HR less than 1 indicated a reduction in hazard rate in favor of crizotinib.||0.773|0.452|0.0002
72472411|NCT01154140|144467943|SUPERIORITY_OR_OTHER||Mean Difference (Net)|13.8303|||<|0.0001|TWO_SIDED|95.0|10.74|16.92|||Mixed Models Analysis|||QLQ-C30 Global QoL: Analysis was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-C30 subscale baseline score (intercept and time from first dose are included as random effects).||16.92|10.74|<0.0001
72472412|NCT01154140|144467943|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.3532||||0.017|TWO_SIDED|95.0|0.6|6.11|||Mixed Models Analysis|||QLQ-C30 cognitive functioning: Analysis was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-C30 subscale baseline score (intercept and time from first dose are included as random effects).||6.11|0.60|0.0170
72397836|NCT01313767|144301811|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.0172||||0.8553|TWO_SIDED||||||Chi-squared|||Difference between groups in frequency of responders who have improved at least 1-point on the MAS at week 12 from baseline in thumb flexor was compared using Pearson's chi-square test.||||0.8553
72397837|NCT01313767|144301812|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.07||||0.604|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Difference between groups in change from baseline to week 4 in DAS score of hygiene was compared using wilcoxon rank sum test.||||0.6040
72397838|NCT01313767|144301812|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.15||||0.3233|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Difference between groups in change from baseline to week 8 in DAS score of hygiene was compared using wilcoxon rank sum test.||||0.3233
72397839|NCT01313767|144301812|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.12||||0.4469|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Difference between groups in change from baseline to week 12 in DAS score of hygiene was compared using wilcoxon rank sum test.||||0.4469
72397840|NCT01313767|144301813|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.37||||0.122|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Difference between groups in change from baseline to week 4 in DAS score of dressing was compared using wilcoxon rank sum test.||||0.1220
72397841|NCT01313767|144301813|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.41||||0.1016|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Difference between groups in change from baseline to week 8 in DAS score of dressing was compared using wilcoxon rank sum test.||||0.1016
72397842|NCT01313767|144301813|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.32||||0.2235|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Difference between groups in change from baseline to week 12 in DAS score of dressing was compared using wilcoxon rank sum test.||||0.2235
72397843|NCT01313767|144301814|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.08||||0.503|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Difference between groups in change from baseline to week 4 in DAS score of limb position was compared using wilcoxon rank sum test.||||0.5030
72397844|NCT01313767|144301814|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.04||||0.6934|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Difference between groups in change from baseline to week 8 in DAS score of limb position was compared using wilcoxon rank sum test.||||0.6934
72397845|NCT01313767|144301814|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01||||0.9574|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Difference between groups in change from baseline to week 12 in DAS score of limb position was compared using wilcoxon rank sum test.||||0.9574
72472413|NCT01154140|144467943|SUPERIORITY_OR_OTHER||Mean Difference (Net)|7.5165|||<|0.0001|TWO_SIDED|95.0|4.57|10.46|||Mixed Models Analysis|||QLQ-C30 emotional functioning: Analysis was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-C30 subscale baseline score (intercept and time from first dose are included as random effects).||10.46|4.57|<0.0001
72472414|NCT01154140|144467943|SUPERIORITY_OR_OTHER||Mean Difference (Net)|10.4035|||<|0.0001|TWO_SIDED|95.0|7.48|13.32|||Mixed Models Analysis|||QLQ-C30 physical functioning: Analysis was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-C30 subscale baseline score (intercept and time from first dose are included as random effects).||13.32|7.48|<0.0001
72472415|NCT01154140|144467943|SUPERIORITY_OR_OTHER||Mean Difference (Net)|15.5513|||<|0.0001|TWO_SIDED|95.0|11.29|19.81|||Mixed Models Analysis|||QLQ-C30 role functioning: Analysis was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-C30 subscale baseline score (intercept and time from first dose are included as random effects).||19.81|11.29|<0.0001
72472416|NCT01154140|144467943|SUPERIORITY_OR_OTHER||Mean Difference (Net)|8.7641|||<|0.0001|TWO_SIDED|95.0|4.69|12.84|||Mixed Models Analysis|||QLQ-C30 social functioning: Analysis was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-C30 subscale baseline score (intercept and time from first dose are included as random effects).||12.84|4.69|<0.0001
72472417|NCT01154140|144467944|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-13.4976|||<|0.0001|TWO_SIDED|95.0|-18.03|-8.97|||Mixed Models Analysis|||QLQ-C30 appetite loss: Analysis was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-C30 subscale baseline score (intercept and time from first dose are included as random effects).||-8.97|-18.03|<0.0001
72472418|NCT01154140|144467944|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.4336||||0.057|TWO_SIDED|95.0|-9.0|0.13|||Mixed Models Analysis|||QLQ-C30 constipation: Analysis was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-C30 subscale baseline score (intercept and time from first dose are included as random effects).||0.13|-9.00|0.0570
72472419|NCT01154140|144467944|SUPERIORITY_OR_OTHER||Mean Difference (Net)|12.4906|||<|0.0001|TWO_SIDED|95.0|8.98|16.0|||Mixed Models Analysis|||QLQ-C30 diarrhea: Analysis was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-C30 subscale baseline score (intercept and time from first dose are included as random effects).||16.00|8.98|<0.0001
72472420|NCT01154140|144467944|SUPERIORITY_OR_OTHER||Median Difference (Net)|-13.4622|||<|0.0001|TWO_SIDED|95.0|-17.2|-9.73|||Mixed Models Analysis|||QLQ-C30 dysponea: Analysis was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-C30 subscale baseline score (intercept and time from first dose are included as random effects).||-9.73|-17.20|<0.0001
72472421|NCT01154140|144467944|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-14.9987|||<|0.0001|TWO_SIDED|95.0|-18.52|-11.48|||Mixed Models Analysis|||QLQ-C30 fatigue: Analysis was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-C30 subscale baseline score (intercept and time from first dose are included as random effects).||-11.48|-18.52|<0.0001
72623026|NCT01299961|144776387|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.0|STANDARD_DEVIATION|3.7|<|0.01|TWO_SIDED||||||t-test, 2 sided|||7 joints were scanned by power doppler ultra sound of the most affected side: wrist, MCP 2/3, PIP 2/3, and MTP 2/5. PDUS was scored semi-quantitatively on a scale of 0-3 (higher score is worse). The mean score of the 2-3 views obtained for each joint was added across all 7 joints, and the total PDUS (range 0-21) scores were calculated. The change from baseline to 12 months is calculated as the baseline PDUS minus 12 month PDUS.||||<0.01
72397846|NCT01313767|144301815|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.25||||0.7237|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Difference between groups in change from baseline to week 4 in DAS score of pain was compared using wilcoxon rank sum test.||||0.7237
72472422|NCT01154140|144467944|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.8186||||0.6681|TWO_SIDED|95.0|-4.56|2.92|||Mixed Models Analysis|||QLQ-C30 financial difficulties: Analysis was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-C30 subscale baseline score (intercept and time from first dose are included as random effects).||2.92|-4.56|0.6681
72472423|NCT01154140|144467944|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-10.043|||<|0.0001|TWO_SIDED|95.0|-14.22|-5.87|||Mixed Models Analysis|||QLQ-C30 insomnia: Analysis was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-C30 subscale baseline score (intercept and time from first dose are included as random effects).||-5.87|-14.22|<0.0001
72472424|NCT01154140|144467944|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.4446||||0.0468|TWO_SIDED|95.0|-6.84|-0.05|||Mixed Models Analysis|||QLQ-C30 nausea and vomiting: Analysis was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-C30 subscale baseline score (intercept and time from first dose are included as random effects).||-0.05|-6.84|0.0468
72472425|NCT01154140|144467944|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-9.9277|||<|0.0001|TWO_SIDED|95.0|-13.23|-6.62|||Mixed Models Analysis|||QLQ-C30 pain: Analysis was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-C30 subscale baseline score (intercept and time from first dose are included as random effects).||-6.62|-13.23|<0.0001
72472426|NCT01154140|144467945|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.8149||||0.0108|TWO_SIDED|95.0|-8.52|-1.11|||Mixed Models Analysis|||QLQ-LC13 alopecia: Analysis was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-LC13 subscale baseline score (intercept and time from first dose are included as random effects).||-1.11|-8.52|0.0108
72472427|NCT01154140|144467945|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-8.3926|||<|0.0001|TWO_SIDED|95.0|-12.06|-4.72|||Mixed Models Analysis|||QLQ-LC13 coughing: Analysis was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-LC13 subscale baseline score (intercept and time from first dose are included as random effects).||-4.72|-12.06|<0.0001
72472428|NCT01154140|144467945|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.6651||||0.5938|TWO_SIDED|95.0|-1.78|3.11|||Mixed Models Analysis|||QLQ-LC13 dysphagia: Analysis was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-LC13 subscale baseline score (intercept and time from first dose are included as random effects).||3.11|-1.78|0.5938
72472429|NCT01154140|144467945|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-9.008|||<|0.0001|TWO_SIDED|95.0|-11.96|-6.06|||Mixed Models Analysis|||QLQ-LC13 dyspnoea: Analysis was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-LC13 subscale baseline score (intercept and time from first dose are included as random effects).||-6.06|-11.96|<0.0001
72472430|NCT01154140|144467945|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.8828||||0.0656|TWO_SIDED|95.0|-1.82|0.06|||Mixed Models Analysis|||QLQ-LC13 haemoptysis: Analysis was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-LC13 subscale baseline score (intercept and time from first dose are included as random effects).||0.06|-1.82|0.0656
72472431|NCT01154140|144467945|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-6.0475||||0.0002|TWO_SIDED|95.0|-9.22|-2.88|||Mixed Models Analysis|||QLQ-LC13 pain in arm or shoulder: Analysis was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-LC13 subscale baseline score (intercept and time from first dose are included as random effects).||-2.88|-9.22|0.0002
72472432|NCT01154140|144467945|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-8.0959|||<|0.0001|TWO_SIDED|95.0|-11.35|-4.84|||Mixed Models Analysis|||QLQ-LC13 pain in chest: Analysis was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-LC13 subscale baseline score (intercept and time from first dose are included as random effects).||-4.84|-11.35|<0.0001
72472433|NCT01154140|144467945|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-6.7717||||0.0001|TWO_SIDED|95.0|-10.24|-3.31|||Mixed Models Analysis|||QLQ-LC13 pain in other parts: Analysis was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-LC13 subscale baseline score (intercept and time from first dose are included as random effects).||-3.31|-10.24|0.0001
72472434|NCT01154140|144467945|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.3521||||0.0427|TWO_SIDED|95.0|0.11|6.59|||Mixed Models Analysis|||QLQ-LC13 peripheral neuropathy: Analysis was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-LC13 subscale baseline score (intercept and time from first dose are included as random effects).||6.59|0.11|0.0427
72506626|NCT01899144|144545116|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.45|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001|TWO_SIDED|95.0|0.26|0.64|||ANOVA|Mixed effect analysis of variance with fixed effects of sequence, treatment group, and period, and random effect for the patient within sequence|Active - Placebo|"The mean difference between each active group and placebo was tested in a sequential manner:~* Albuterol MDPI 180 mcg to placebo~* Albuterol MDPI 90 mcg to placebo~* ProAir HFA 180 mcg to placebo~* ProAir HFA 90 mcg to placebo Each test was 2 sided and done at the 0.05 level of significance. However, if a test was not significant at this level, no further tests were done. This sequential process assured that the overall alpha level for the entire series was not greater than 0.05."||0.64|0.26|<0.0001
72472435|NCT01154140|144467945|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.1521||||0.1382|TWO_SIDED|95.0|-5.0|0.69|||Mixed Models Analysis|||QLQ-LC13 sore mouth: Analysis was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-LC13 subscale baseline score (intercept and time from first dose are included as random effects).||0.69|-5.00|0.1382
72472436|NCT01154140|144467946|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.9908||||0.0139|TWO_SIDED|95.0|0.81|7.17|||Mixed Models Analysis|||Analysis was based on a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EQ-5D VAS subscale baseline score (intercept and time from first dose were included as random effects).||7.17|0.81|0.0139
72472437|NCT00478192|144467950|SUPERIORITY_OR_OTHER|||||||0.028||95.0||||P-Values are not adjusted on the basis of multiple comparrisons|ANCOVA|||"Statistical Analysis applies to Change from Baseline."||||0.028
72472438|NCT00478192|144467950|SUPERIORITY_OR_OTHER|||||||0.019||95.0||||P-Values are not adjusted on the basis of multiple comparrisons|ANCOVA|||"Statistical Analysis applies to Change from Baseline."||||0.019
72472439|NCT00478192|144467950|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-Values are not adjusted on the basis of multiple comparrisons|ANCOVA|||"Statistical Analysis applies to Change from Baseline."||||<0.001
72472440|NCT00478192|144467955|SUPERIORITY_OR_OTHER|||||||0.079||95.0|||||ANCOVA|||||||0.079
72472441|NCT05239598|144467971|SUPERIORITY||Mean Difference (Net)|4.5||||0.287|TWO_SIDED|95.0|-4.0|13.0|||t-test, 2 sided|||||13.0|-4.0|0.287
72472442|NCT05239598|144467972|SUPERIORITY||Mean Difference (Net)|1.7||||0.625|TWO_SIDED|95.0|-5.2|8.6|||t-test, 2 sided|||5 minutes post intervention||8.6|-5.2|0.625
72472443|NCT05239598|144467972|SUPERIORITY||Mean Difference (Net)|2.5||||0.526|TWO_SIDED|95.0|-5.5|10.5|||t-test, 2 sided|||30 minutes post intervention||10.5|-5.5|0.526
72472444|NCT05239598|144467973|SUPERIORITY||Median Difference (Net)|0.04||||0.511|TWO_SIDED|95.0|-4.2|8.1|||Signed Rank|||Povidone-iodine: 5 minutes Post-Intervention||8.1|-4.2|0.511
72472445|NCT05239598|144467973|SUPERIORITY||Median Difference (Net)|5.4||||0.408|TWO_SIDED|95.0|-10.7|18.6|||Signed Rank|||Povidone-iodine: 30 minutes post-intervention||18.6|-10.7|0.408
72472446|NCT05239598|144467973|SUPERIORITY||Median Difference (Net)|-4.9||||0.907|TWO_SIDED|95.0|-15.2|17.5|||Signed Rank|||Povidone-iodine: 60 minutes post-intervention||17.5|-15.2|0.907
72472447|NCT05239598|144467973|SUPERIORITY||Median Difference (Net)|-2.4||||0.008|TWO_SIDED|95.0|-6.5|-0.9|||Signed Rank|||Placebo: 5 minutes post intervention||-0.9|-6.5|0.008
72472448|NCT05239598|144467973|SUPERIORITY||Median Difference (Net)|-6.6||||0.08|TWO_SIDED|95.0|-10.1|-2.2|||Signed Rank|||Placebo: 30 minutes post-intervention||-2.2|-10.1|0.080
72472449|NCT05239598|144467973|SUPERIORITY||Median Difference (Net)|-8.6||||0.001|TWO_SIDED|95.0|-22.3|-3.9|||Signed Rank|||Placebo: 60 minutes post-intervention||-3.9|-22.3|0.001
72472450|NCT05239598|144467974|SUPERIORITY||Median Difference (Net)|3.1||||0.212|TWO_SIDED|95.0|-2.2|5.8|||Signed Rank|||Povidone-iodine 5 minutes post-intervention||5.8|-2.2|0.212
72472451|NCT05239598|144467974|SUPERIORITY||Median Difference (Net)|1.8||||0.334|TWO_SIDED|95.0|-2.3|6.9|||Signed Rank|||Povidone-iodine 30 minutes post-intervention||6.9|-2.3|0.334
72472452|NCT05239598|144467974|SUPERIORITY||Median Difference (Net)|1.5||||0.269|TWO_SIDED|95.0|-3.1|6.8|||Signed Rank|||Povidone-iodine 60 minutes post-intervention||6.8|-3.1|0.269
72472453|NCT05239598|144467974|SUPERIORITY||Median Difference (Net)|-4.1||||0.026|TWO_SIDED|95.0|-7.1|-0.7|||Signed Rank|||Placebo 5 minutes post-intervention||-0.7|-7.1|0.026
72472454|NCT05239598|144467974|SUPERIORITY||Median Difference (Net)|-0.7||||0.182|TWO_SIDED|95.0|-9.4|2.0|||Signed Rank|||Placebo 30 minutes post-intervention||2.0|-9.4|0.182
72472455|NCT05239598|144467974|SUPERIORITY||Median Difference (Net)|-3.6||||0.353|TWO_SIDED|95.0|-7.7|4.0|||Signed Rank|||Placebo 60 minutes post-intervention||4.0|-7.7|0.353
72472456|NCT01424813|144467993|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.83|STANDARD_ERROR_OF_MEAN|0.128|<|0.0001|TWO_SIDED|95.0|0.57|1.08||Significance at the 0.05 level.|mixed-model repeated-measures (MMRM)|Fixed effects- pooled center, treatment group, study day, and study day by drug interaction, with baseline measured at each study day as covariate.||||1.08|0.57|<0.0001
72472457|NCT01424813|144467994|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.07|STANDARD_ERROR_OF_MEAN|0.198|<|0.0001|TWO_SIDED|95.0|0.68|1.46||To adjust for multiplicity, so that the overall alpha level for all tests was controlled at the 0.05 level, tests were done sequentially \[day 1, then day 8, then day 85\] and terminated if individual results were not significant at the 0.05 level.|mixed model repeated measures (MMRM)|Fixed effects- pooled center, treatment group, study day, and study day by drug interaction, with baseline measured at each study day as covariate.||||1.46|0.68|<0.0001
72397847|NCT01313767|144301815|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.25||||0.7237|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Difference between groups in change from baseline to week 8 in DAS score of pain was compared using wilcoxon rank sum test.||||0.7237
72397848|NCT01313767|144301815|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.5||||0.4017|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Difference between groups in change from baseline to week 12 in DAS score of pain was compared using wilcoxon rank sum test.||||0.4017
72472458|NCT01424813|144468009|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.73|STANDARD_ERROR_OF_MEAN|0.164|<|0.0001|TWO_SIDED|95.0|0.41|1.06||To adjust for multiplicity, so that the overall alpha level for all tests was controlled at the 0.05 level, tests were done sequentially \[day 1, then day 8, then day 85\] and terminated if individual results were not significant at the 0.05 level.|mixed model repeated measures (MMRM)|Fixed effects- pooled center, treatment group, study day, and study day by drug interaction, with baseline measured at each study day as covariate.||||1.06|0.41|<0.0001
72472459|NCT01424813|144468010|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.68|STANDARD_ERROR_OF_MEAN|0.154|<|0.0001|TWO_SIDED|95.0|0.38|0.99||To adjust for multiplicity, so that the overall alpha level for all tests was controlled at the 0.05 level, tests were done sequentially \[day 1, then day 8, then day 85\] and terminated if individual results were not significant at the 0.05 level.|mixed model repeated measures (MMRM)|Fixed effects- pooled center, treatment group, study day, and study day by drug interaction, with baseline measured at each study day as covariate.||||0.99|0.38|<0.0001
72472460|NCT04991753|144468015|SUPERIORITY||Least square mean difference|-0.45|||=|0.224|TWO_SIDED|95.0|-1.17|0.28|||ANCOVA|||||0.28|-1.17|=0.224
72472461|NCT03299049|144468031|NON_INFERIORITY|Non-inferiority was concluded if the upper bound of the two-sided 95% confidence interval (CI) for the Cochran-Mantel Haenzel (CMH) adjusted treatment difference (Q8W minus Q4W) is less than 4%.|Adjusted difference|0.8|||||TWO_SIDED|95.0|-0.6|2.2|||||Adjusted CMH estimate of the difference in the percentage of participants with Plasma HIV-1 \>=50 c/mL between each treatment group (Q8W - Q4W) and corresponding 95% CI is presented.|||2.2|-0.6|
72472462|NCT03299049|144468032|NON_INFERIORITY|Non-inferiority was concluded if the upper bound of the two-sided 95% CI for the CMH adjusted treatment difference (Q8W minus Q4W) is greater than -10%|Adjusted difference|0.8|||||TWO_SIDED|95.0|-2.1|3.7|||||Adjusted CMH estimate of the difference in the percentage of participants with Plasma HIV-1 \<50 c/mL between each treatment group (Q8W-Q4W) and corresponding 95% CI is presented.|||3.7|-2.1|
72472463|NCT01901419|144468079|SUPERIORITY|||||||0.618|||||||t-test, 2 sided|||||||0.618
72472464|NCT01901419|144468080|SUPERIORITY|||||||0.41|||||||t-test, 2 sided|||||||0.410
72472465|NCT01901419|144468081|SUPERIORITY|||||||0.088|||||||t-test, 2 sided|||||||0.088
72472466|NCT01901419|144468082|SUPERIORITY|||||||0.32|||||||t-test, 2 sided|||||||0.320
72472467|NCT01901419|144468083|SUPERIORITY|||||||0.512|||||||t-test, 2 sided|||||||0.512
72472468|NCT01901419|144468084|SUPERIORITY|||||||0.144|||||||t-test, 2 sided|||||||0.144
72472469|NCT01901419|144468085|SUPERIORITY|||||||0.338|||||||t-test, 2 sided|||||||0.338
72472470|NCT01901419|144468086|SUPERIORITY|||||||0.356|||||||t-test, 2 sided|||||||0.356
72472471|NCT01901419|144468087|SUPERIORITY|||||||0.478|||||||t-test, 2 sided|||||||0.478
72472472|NCT01901419|144468088|SUPERIORITY|||||||0.515|||||||t-test, 2 sided|||||||0.515
72472473|NCT01901419|144468089|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||<0.001
72472474|NCT01901419|144468090|SUPERIORITY|||||||0.227|||||||t-test, 2 sided|||||||0.227
72472475|NCT01901419|144468091|SUPERIORITY|||||||0.141|||||||t-test, 2 sided|||||||0.141
72472476|NCT01901419|144468092|SUPERIORITY|||||||0.046|||||||t-test, 2 sided|||||||0.046
72472477|NCT01901419|144468093|SUPERIORITY|||||||0.8|||||||t-test, 2 sided|||||||0.800
72472478|NCT01901419|144468094|SUPERIORITY|||||||0.948|||||||t-test, 2 sided|||||||0.948
72472479|NCT01901419|144468095|SUPERIORITY|||||||0.682|||||||t-test, 2 sided|||||||0.682
72472480|NCT01901419|144468096|SUPERIORITY|||||||0.928|||||||t-test, 2 sided|||||||0.928
72472481|NCT01901419|144468097|SUPERIORITY|||||||0.672|||||||t-test, 2 sided|||||||0.672
72472482|NCT01901419|144468098|SUPERIORITY|||||||0.894|||||||t-test, 2 sided|||||||0.894
72472483|NCT01901419|144468099|SUPERIORITY|||||||0.135|||||||t-test, 2 sided|||||||0.135
72472484|NCT01901419|144468100|SUPERIORITY|||||||0.038|||||||t-test, 2 sided|||||||0.038
72472485|NCT01901419|144468101|SUPERIORITY|||||||0.852|||||||t-test, 2 sided|||||||0.852
72472486|NCT01901419|144468102|SUPERIORITY|||||||0.454|||||||t-test, 2 sided|||||||0.454
72472487|NCT01901419|144468103|SUPERIORITY|||||||0.663|||||||t-test, 2 sided|||||||0.663
72472488|NCT01901419|144468104|SUPERIORITY|||||||0.872|||||||t-test, 2 sided|||||||0.872
72472489|NCT01901419|144468105|SUPERIORITY|||||||0.318|||||||t-test, 2 sided|||||||0.318
72472490|NCT01901419|144468106|SUPERIORITY|||||||0.365|||||||t-test, 2 sided|||||||0.365
72472491|NCT01901419|144468107|SUPERIORITY|||||||0.077|||||||t-test, 2 sided|||||||0.077
72472492|NCT01901419|144468108|SUPERIORITY|||||||0.64|||||||t-test, 2 sided|||||||0.640
72472493|NCT02412735|144468113|SUPERIORITY|The superiority threshold was 0.9875.|||||||||||||||||The posterior probability of superiority to placebo was 0.2072.|||
72472494|NCT02412735|144468113|SUPERIORITY|The superiority threshold was 0.9875.|||||||||||||||||The posterior probability of superiority to placebo was 0.6427.|||
72472495|NCT02412735|144468114|SUPERIORITY|The superiority threshold was 0.9875.|||||||||||||||||The posterior probability of superiority to placebo was 0.2754.|||
72472496|NCT02412735|144468114|SUPERIORITY|The superiority threshold was 0.9875.|||||||||||||||||The posterior probability of superiority to placebo was 0.9087.|||
72472497|NCT02412735|144468115|SUPERIORITY|The superiority threshold was 0.9875.|||||||||||||||||The posterior probability of superiority to placebo was 0.2835.|||
72472498|NCT02412735|144468115|SUPERIORITY|The superiority threshold was 0.9875.|||||||||||||||||The posterior probability of superiority to placebo was 0.4739.|||
72472499|NCT02412735|144468116|SUPERIORITY|The superiority threshold was 0.9875.|||||||||||||||||The posterior probability of superiority to placebo was 0.2650.|||
72472500|NCT02412735|144468116|SUPERIORITY|The superiority threshold was 0.9875.|||||||||||||||||The posterior probability of superiority to placebo was 0.7004.|||
72472501|NCT02412735|144468117|SUPERIORITY|The superiority threshold was 0.9875.|||||||||||||||||The posterior probability of superiority to placebo was 0.1945.|||
72472502|NCT02412735|144468117|SUPERIORITY|The superiority threshold was 0.9875.|||||||||||||||||The posterior probability of superiority to placebo was 0.8093.|||
72472503|NCT02412735|144468118|SUPERIORITY||Hazard Ratio (HR)|1.11||||0.7842|TWO_SIDED|95.0|0.5|2.46|||Regression, Cox|P-value was calculated from a Cox regression model with treatment, pooled site, and opioid/non opioid use at Baseline as covariates.|Hazard ratio and 95% confidence interval (CI) were calculated from a Cox regression model with treatment, pooled site, and opioid/non opioid use at Baseline as covariates.|||2.46|0.50|0.7842
72472504|NCT02412735|144468118|SUPERIORITY||Hazard Ratio (HR)|0.93||||0.8754|TWO_SIDED|95.0|0.41|2.14|||Regression, Cox|P-value was calculated from a Cox regression model with treatment, pooled site, and opioid/non opioid use at Baseline as covariates.|Hazard ratio and 95% CI were calculated from a Cox regression model with treatment, pooled site, and opioid/non opioid use at Baseline as covariates.|||2.14|0.41|0.8754
72472505|NCT02412735|144468119|SUPERIORITY|The superiority threshold was 0.9875.|||||||||||||||||The posterior probability of superiority to placebo was 0.2309.|||
72472506|NCT02412735|144468119|SUPERIORITY|The superiority threshold was 0.9875.|||||||||||||||||The posterior probability of superiority to placebo was 0.1241.|||
72472507|NCT02412735|144468120|SUPERIORITY||Least Squares Mean Difference|0.4|STANDARD_ERROR_OF_MEAN|3.08||0.9072|TWO_SIDED|95.0|-5.71|6.43|||Mixed Model for Repeated Measures (MMRM)|MMRM was used with fixed effects of pooled site,baseline use of opioids,treatment,visit,treatment-by-visit interaction\&continuous covariate baseline.||Mean Change from Baseline in Low Back Pain VAS Score at Month 1||6.43|-5.71|0.9072
72472508|NCT02412735|144468120|SUPERIORITY||Least Squares Mean Difference|-3.3|STANDARD_ERROR_OF_MEAN|3.14||0.2883|TWO_SIDED|95.0|-9.51|2.83|||MMRM|MMRM was used with fixed effects of pooled site,baseline use of opioids,treatment,visit,treatment-by-visit interaction\&continuous covariate baseline.||Mean Change from Baseline in Low Back Pain VAS Score at Month 1||2.83|-9.51|0.2883
72472509|NCT02412735|144468120|SUPERIORITY||Least Squares Mean Difference|-1.6|STANDARD_ERROR_OF_MEAN|3.23||0.6314|TWO_SIDED|95.0|-7.9|4.8|||MMRM|MMRM was used with fixed effects of pooled site,baseline use of opioids,treatment,visit,treatment-by-visit interaction\&continuous covariate baseline.||Mean Change from Baseline in Low Back Pain VAS Score at Month 3||4.80|-7.90|0.6314
72472510|NCT02412735|144468120|SUPERIORITY||Least Squares Mean Difference|-4.9|STANDARD_ERROR_OF_MEAN|3.29||0.1366|TWO_SIDED|95.0|-11.37|1.56|||MMRM|MMRM was used with fixed effects of pooled site,baseline use of opioids,treatment,visit,treatment-by-visit interaction\&continuous covariate baseline.||Mean Change from Baseline in Low Back Pain VAS Score at Month 3||1.56|-11.37|0.1366
72472511|NCT02412735|144468120|SUPERIORITY||Least Squares Mean Difference|-3.9|STANDARD_ERROR_OF_MEAN|3.34||0.2497|TWO_SIDED|95.0|-10.43|2.72|||MMRM|MMRM was used with fixed effects of pooled site,baseline use of opioids,treatment,visit,treatment-by-visit interaction\&continuous covariate baseline.||Mean Change from Baseline in Low Back Pain VAS Score at Month 6||2.72|-10.43|0.2497
72472512|NCT02412735|144468120|SUPERIORITY||Least Squares Mean Difference|-6.3|STANDARD_ERROR_OF_MEAN|3.42||0.0666|TWO_SIDED|95.0|-13.0|0.43|||MMRM|MMRM was used with fixed effects of pooled site,baseline use of opioids,treatment,visit,treatment-by-visit interaction\&continuous covariate baseline.||Mean Change from Baseline in Low Back Pain VAS Score at Month 6||0.43|-13.00|0.0666
72472513|NCT02412735|144468120|SUPERIORITY||Least Squares Mean Difference|-4.2|STANDARD_ERROR_OF_MEAN|3.4||0.2147|TWO_SIDED|95.0|-10.91|2.46|||MMRM|MMRM was used with fixed effects of pooled site,baseline use of opioids,treatment,visit,treatment-by-visit interaction\&continuous covariate baseline.||Mean Change from Baseline in Low Back Pain VAS Score at Month 12||2.46|-10.91|0.2147
72472514|NCT02412735|144468120|SUPERIORITY||Least Squares Mean Difference|-8.4|STANDARD_ERROR_OF_MEAN|3.47||0.0162|TWO_SIDED|95.0|-15.19|-1.55|||MMRM|MMRM was used with fixed effects of pooled site,baseline use of opioids,treatment,visit,treatment-by-visit interaction\&continuous covariate baseline.||Mean Change from Baseline in Low Back Pain VAS Score at Month 12||-1.55|-15.19|0.0162
72472515|NCT02412735|144468120|SUPERIORITY||Least Squares Mean Difference|-4.5|STANDARD_ERROR_OF_MEAN|3.67||0.223|TWO_SIDED|95.0|-11.69|2.74|||MMRM|MMRM was used with fixed effects of pooled site,baseline use of opioids,treatment,visit,treatment-by-visit interaction\&continuous covariate baseline.||Mean Change from Baseline in Low Back Pain VAS Score at Month 18||2.74|-11.69|0.2230
72472516|NCT02412735|144468120|SUPERIORITY||Least Squares Mean Difference|-5.9|STANDARD_ERROR_OF_MEAN|3.74||0.1152|TWO_SIDED|95.0|-13.27|1.45|||MMRM|MMRM was used with fixed effects of pooled site,baseline use of opioids,treatment,visit,treatment-by-visit interaction\&continuous covariate baseline.||Mean Change from Baseline in Low Back Pain VAS Score at Month 18||1.45|-13.27|0.1152
72397849|NCT01313767|144301816|SUPERIORITY_OR_OTHER|||||||0.2346|TWO_SIDED||||||Fisher Exact|||Difference between groups in frequency distribution of responders on the Global Assessment at week 12 was compared using Fisher's exact test.||||0.2346
72397850|NCT01313767|144301817|SUPERIORITY_OR_OTHER|||||||0.9513|TWO_SIDED||||||Fisher Exact|||Difference between groups in frequency distribution of responders on the Global Assessment at week 12 was compared using Fisher's exact test.||||0.9513
72397851|NCT01313767|144301818|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.06||||0.8088|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Difference between groups in change from baseline to week 4 in carer burden scale of cleaning the palm was compared using wilcoxon rank sum test.||||0.8088
72472517|NCT02412735|144468120|SUPERIORITY||Least Squares Mean Difference|-2.5|STANDARD_ERROR_OF_MEAN|3.66||0.4884|TWO_SIDED|95.0|-9.75|4.67|||MMRM|MMRM was used with fixed effects of pooled site,baseline use of opioids,treatment,visit,treatment-by-visit interaction\&continuous covariate baseline.||Mean Change from Baseline in Low Back Pain VAS Score at Month 24||4.67|-9.75|0.4884
72472518|NCT02412735|144468120|SUPERIORITY||Least Squares Mean Difference|-7.6|STANDARD_ERROR_OF_MEAN|3.74||0.0426|TWO_SIDED|95.0|-14.98|-0.25|||MMRM|MMRM was used with fixed effects of pooled site,baseline use of opioids,treatment,visit,treatment-by-visit interaction\&continuous covariate baseline.||Mean Change from Baseline in Low Back Pain VAS Score at Month 24||-0.25|-14.98|0.0426
72472519|NCT02412735|144468120|SUPERIORITY||Least Squares Mean Difference|-3.9|STANDARD_ERROR_OF_MEAN|3.77||0.3056|TWO_SIDED|95.0|-11.27|3.54|||MMRM|MMRM was used with fixed effects of pooled site,baseline use of opioids,treatment,visit,treatment-by-visit interaction\&continuous covariate baseline.||Mean Change from Baseline in Low Back Pain VAS Score at Month 36||3.54|-11.27|0.3056
72472520|NCT02412735|144468120|SUPERIORITY||Least Squares Mean Difference|-6.0|STANDARD_ERROR_OF_MEAN|3.85||0.1184|TWO_SIDED|95.0|-13.59|1.54|||MMRM|MMRM was used with fixed effects of pooled site,baseline use of opioids,treatment,visit,treatment-by-visit interaction\&continuous covariate baseline.||Mean Change from Baseline in Low Back Pain VAS Score at Month 36||1.54|-13.59|0.1184
72472521|NCT01602510|144468140|SUPERIORITY_OR_OTHER||Adjusted Hazard Ratio|0.86|||=|0.438|TWO_SIDED|95.0|0.59|1.25|||Regression, Cox||p value with Treatment Group as covariate|||1.25|0.59|=0.438
72472522|NCT01602510|144468140|SUPERIORITY_OR_OTHER||Adjusted Hazard Ratio|0.86|||=|0.212|TWO_SIDED|95.0|0.59|1.25|||Regression, Cox||p value with Site as covariate|||1.25|0.59|=0.212
72397852|NCT01313767|144301818|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.18||||0.3702|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Difference between groups in change from baseline to week 8 in carer burden scale of cleaning the palm was compared using wilcoxon rank sum test.||||0.3702
72397853|NCT01313767|144301818|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.28||||0.1497|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Difference between groups in change from baseline to week 12 in carer burden scale of cleaning the palm was compared using wilcoxon rank sum test.||||0.1497
72397854|NCT01313767|144301819|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.13||||0.9634|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Difference between groups in change from baseline to week 4 in carer burden scale of cutting the finger-nails was compared using wilcoxon rank sum test.||||0.9634
72397855|NCT01313767|144301819|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.12||||0.7302|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Difference between groups in change from baseline to week 8 in carer burden scale of cutting the finger-nails was compared using wilcoxon rank sum test.||||0.7302
72397856|NCT01313767|144301819|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.07||||0.7715|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Difference between groups in change from baseline to week 12 in carer burden scale of cutting the finger-nails was compared using wilcoxon rank sum test.||||0.7715
72472523|NCT01602510|144468140|SUPERIORITY_OR_OTHER||Adjusted Hazard Ratio|0.86|||=|0.724|TWO_SIDED|95.0|0.59|1.25|||Regression, Cox||p value with CGI-S Baseline Score as covariate|||1.25|0.59|=0.724
72472524|NCT01602510|144468141|SUPERIORITY_OR_OTHER||Adjusted Hazard Ratio|0.95|||=|0.869|TWO_SIDED|95.0|0.55|1.66|||Regression, Cox||p value with Treatment Group as covariate|||1.66|0.55|=0.869
72472525|NCT01602510|144468141|SUPERIORITY_OR_OTHER||Adjusted Hazard Ratio|0.95|||=|0.061|TWO_SIDED|95.0|0.55|1.66|||Regression, Cox||p value with Site as covariate|||1.66|0.55|=0.061
72472526|NCT01602510|144468141|SUPERIORITY_OR_OTHER||Adjusted Hazard Ratio|0.95|||=|0.505|TWO_SIDED|95.0|0.55|1.66|||Regression, Cox||p value with CGI-S Baseline Score as covariate|||1.66|0.55|=0.505
72472527|NCT01602510|144468142|SUPERIORITY_OR_OTHER||Adjusted Hazard Ratio|0.79|||=|0.369|TWO_SIDED|95.0|0.48|1.32|||Regression, Cox||p value with Treatment Group as covariate|||1.32|0.48|=0.369
72472528|NCT01602510|144468142|SUPERIORITY_OR_OTHER||Adjusted Hazard Ratio|0.79|||=|0.955|TWO_SIDED|95.0|0.48|1.32|||Regression, Cox||p value with Site as covariate|||1.32|0.48|=0.955
72472529|NCT01602510|144468142|SUPERIORITY_OR_OTHER||Adjusted Hazard Ratio|0.79|||=|0.874|TWO_SIDED|95.0|0.48|1.32|||Regression, Cox||p value with CGI-S Baseline Score as covariate|||1.32|0.48|=0.874
72472530|NCT01602510|144468143|SUPERIORITY_OR_OTHER||Adjusted Hazard Ratio|1.02|||=|0.927|TWO_SIDED|95.0|0.73|1.4|||Regression, Cox||p value with Treatment Group as covariate|||1.40|0.73|=0.927
72472531|NCT01602510|144468143|SUPERIORITY_OR_OTHER||Adjusted Hazard Ratio|1.02|||=|0.036|TWO_SIDED|95.0|0.73|1.4|||Regression, Cox||p value with Site as covariate|||1.40|0.73|=0.036
72472532|NCT01602510|144468143|SUPERIORITY_OR_OTHER||Adjusted Hazard Ratio|1.02|||=|0.509|TWO_SIDED|95.0|0.73|1.4|||Regression, Cox||p value with CGI-S Baseline Score as covariate|||1.40|0.73|=0.509
72472533|NCT01602510|144468144|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|||=|0.833|TWO_SIDED|95.0|-0.4|0.5|||ANCOVA|||||0.5|-0.4|=0.833
72472534|NCT01602510|144468145|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|||=|0.245|TWO_SIDED|95.0|-0.5|0.1|||ANCOVA|||||0.1|-0.5|=0.245
72472535|NCT01602510|144468146|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.2|||=|0.155|TWO_SIDED|95.0|-3.0|0.5|||ANCOVA|||||0.5|-3.0|=0.155
72472536|NCT01602510|144468147|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.4|||=|0.661|TWO_SIDED|95.0|-1.4|2.2|||ANCOVA|||||2.2|-1.4|= 0.661
72472537|NCT01602510|144468148|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|||=|0.945|TWO_SIDED|95.0|-3.7|3.5|||ANCOVA|||||3.5|-3.7|= 0.945
72472538|NCT01602510|144468149|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.84|||=|0.047|TWO_SIDED|95.0|-1.66|-0.01|||ANCOVA|||||-0.01|-1.66|=0.047
72397857|NCT01313767|144301820|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.9362|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Difference between groups in change from baseline to week 4 in carer burden scale of putting shirts on was compared using wilcoxon rank sum test.||||0.9362
72472539|NCT03519204|144468150|SUPERIORITY||Responder Rate Difference|84.7|||<|0.0001|TWO_SIDED|95.0|68.2|94.2||P-value was based on 2-sided Fisher's exact test comparing responder rate between treatment group and no-treated control group.|Fisher Exact|||||94.2|68.2|<0.0001
72472540|NCT03519204|144468152|SUPERIORITY||Median Difference|0.558|STANDARD_ERROR_OF_MEAN|0.109492|<|0.0001|TWO_SIDED|95.0|0.3447|0.7739||P-value was computed using Wilcoxon test with normal approximation.|Wilcoxon Rank-sum Test||The median difference (the location shift) and its 95% CI were computed using Hodges-Lehmann estimation associated with Wilcoxon statistics.|||0.77390|0.34470|<0.0001
72472541|NCT03519204|144468153|SUPERIORITY||Median Difference|13.04|STANDARD_ERROR_OF_MEAN|2.122|<|0.0001|TWO_SIDED|95.0|8.861|17.18||P-value was computed using Wilcoxon test with normal approximation.|Wilcoxon Rank-sum Test||The median difference (the location shift) and its 95% CI were computed using Hodges-Lehmann estimation associated with Wilcoxon statistics.|||17.180|8.861|<0.0001
72472542|NCT02627118|144468157|OTHER|||||||0.05|||||||t-test, 1 sided|||||||0.05
72472543|NCT01572740|144468158|SUPERIORITY_OR_OTHER||Estimated treatment difference, Mean|-1.3|||<|0.0001||95.0|-1.47|-1.13|||ANCOVA|||||-1.13|-1.47|<0.0001
72472544|NCT01572740|144468159|SUPERIORITY_OR_OTHER||Estimated treatment difference, Mean|-0.81|||<|0.0001||95.0|-0.99|-0.63|||ANCOVA|||||-0.63|-0.99|<0.0001
72472545|NCT01572740|144468160|SUPERIORITY_OR_OTHER||Estimated treatment difference, Mean|-0.83|||<|0.0006||95.0|-1.3|-0.36|||ANCOVA|||||-0.36|-1.30|<0.0006
72506627|NCT01899144|144545116|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.26|STANDARD_ERROR_OF_MEAN|0.1||0.0062|TWO_SIDED|95.0|0.08|0.45|||ANOVA|Mixed effect analysis of variance with fixed effects of sequence, treatment group, and period, and random effect for the patient within sequence|Active - Placebo|"The mean difference between each active group and placebo was tested in a sequential manner:~* Albuterol MDPI 180 mcg to placebo~* Albuterol MDPI 90 mcg to placebo~* ProAir HFA 180 mcg to placebo~* ProAir HFA 90 mcg to placebo Each test was 2 sided and done at the 0.05 level of significance. However, if a test was not significant at this level, no further tests were done. This sequential process assured that the overall alpha level for the entire series was not greater than 0.05."||0.45|0.08|0.0062
72397858|NCT01313767|144301820|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.09||||0.7998|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Difference between groups in change from baseline to week 8 in carer burden scale of putting shirts on was compared using wilcoxon rank sum test.||||0.7998
72397859|NCT01313767|144301820|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.13||||0.5436|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Difference between groups in change from baseline to week 12 in carer burden scale of putting shirts on was compared using wilcoxon rank sum test.||||0.5436
72472546|NCT01572740|144468161|SUPERIORITY_OR_OTHER||Estimated treatment difference, Mean|-0.26||||0.2511||95.0|-0.7|0.18|||ANCOVA|||||0.18|-0.70|0.2511
72472547|NCT01572740|144468162|SUPERIORITY_OR_OTHER||Estimated treatment difference, Mean|-1.87|||<|0.0001||95.0|-2.37|-1.38|||ANCOVA|||||-1.38|-2.37|<0.0001
72472548|NCT01572740|144468163|SUPERIORITY_OR_OTHER||Estimated treatment difference, Mean|-1.28|||<|0.0001||95.0|-1.73|-0.83|||ANCOVA|||||-0.83|-1.73|<0.0001
72472549|NCT01572740|144468164|SUPERIORITY_OR_OTHER||Estimated treatment difference, Mean|-0.73||||0.0023||95.0|-1.2|-0.26|||ANCOVA|||||-0.26|-1.20|0.0023
72472550|NCT01572740|144468165|SUPERIORITY_OR_OTHER||Estimated treatment difference, Mean|-0.39||||0.1787||95.0|-0.97|0.18|||ANCOVA|||||0.18|-0.97|0.1787
72472551|NCT01572740|144468166|SUPERIORITY_OR_OTHER||Estimated treatment difference, Mean|-0.14||||0.4806||95.0|-0.54|0.25|||ANCOVA|||||0.25|-0.54|0.4806
72472552|NCT01572740|144468167|SUPERIORITY_OR_OTHER||Estimated treatment difference, Mean|-0.35||||0.2074||95.0|-0.91|0.2|||ANCOVA|||||0.20|-0.91|0.2074
72472553|NCT00477490|144468177|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01||||0.9303|TWO_SIDED|95.0|-0.221|0.242||The a priori statistically significant difference versus placebo is p≤0.05.|ANCOVA|Treatment difference and 95% CI were adjusted for age, absence/presence of nocturnal polyuria, and baseline number of nocturnal voids.||||0.242|-0.221|0.9303
72472554|NCT00477490|144468177|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.12||||0.3104|TWO_SIDED|95.0|-0.353|0.112||The a priori statistically significant difference versus placebo is p≤0.05.|ANCOVA|Treatment difference and 95% CI were adjusted for age, absence/presence of nocturnal polyuria, and baseline number of nocturnal voids.||||0.112|-0.353|0.3104
72472555|NCT00477490|144468177|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.277||||0.0207|TWO_SIDED|95.0|-0.511|-0.042||The a priori statistically significant difference versus placebo is p≤0.05.|ANCOVA|Treatment difference and 95% CI were adjusted for age, absence/presence of nocturnal polyuria, and baseline number of nocturnal voids.||The trial was to be declared positive only if in the 100 μg group, a statistically significant positive effect as compared to placebo on both co-primaries was demonstrated. And only then, the next higher dose group (i.e., 50 μg) could be claimed superior to placebo, if it showed a statistically significant improvement over placebo on both co-primaries.||-0.042|-0.511|0.0207
72472556|NCT00477490|144468177|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.613|||<|0.0001|TWO_SIDED|95.0|-0.848|-0.378||The a priori statistically significant difference versus placebo is p≤0.05.|ANCOVA|Treatment difference and 95% CI were adjusted for age, absence/presence of nocturnal polyuria, and baseline number of nocturnal voids.||The trial was to be declared positive only if in the 100 μg group, a statistically significant positive effect as compared to placebo on both co-primaries was demonstrated. And only then, the next higher dose group (i.e., 50 μg) could be claimed superior to placebo, if it showed a statistically significant improvement over placebo on both co-primaries.||-0.378|-0.848|<0.0001
72472557|NCT00477490|144468178|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.017||||0.942|TWO_SIDED|95.0|0.647|1.598||The a priori statistically significant difference versus placebo is p≤0.05.|Regression, Logistic|Treatment difference and 95% CI were adjusted for age, absence/presence of nocturnal polyuria, and baseline number of nocturnal voids||||1.598|0.647|0.9420
72472558|NCT00477490|144468178|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.147||||0.5527|TWO_SIDED|95.0|0.729|1.807||The a priori statistically significant difference versus placebo is p≤0.05.|Regression, Logistic|Treatment difference and 95% CI were adjusted for age, absence/presence of nocturnal polyuria, and baseline number of nocturnal voids.||||1.807|0.729|0.5527
72506628|NCT01899144|144545116|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.1||0.6342|TWO_SIDED|95.0|-0.23|0.14||0.05 level of significance|ANOVA||90 mcg - 180 mcg|Pre-specified, exploratory analysis||0.14|-0.23|0.6342
72506629|NCT01899144|144545116|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.19|STANDARD_ERROR_OF_MEAN|0.1||0.0488|TWO_SIDED|95.0|-0.38|0.0||0.05 level of significance|ANOVA||90 mcg - 180 mcg|Pre-specified, exploratory analysis||0.00|-0.38|0.0488
72506630|NCT03461289|144545156|SUPERIORITY||Difference of Proportion|0.71|||<|0.0001|TWO_SIDED|95.0|0.48|0.87|||Fisher Exact||||Data for the current study were compared to historical control data (Finkel et al 2014 - PubMed 25080519) where 6 out of 23 (26.1%) babies were alive and did not need mechanical ventilation at 14 months of age.|0.87|0.48|<0.0001
72506631|NCT02222129|144545167|SUPERIORITY_OR_OTHER|||||||0.39|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Statistical analysis was performed using SAS, version 9.2 (Statistical Analysis Software, Cary, NC). All power calculations were at the 80% level with an alpha of 0.05. Based upon opioid consumption data previously reported for robotic-assisted laparoscopic prostatectomy, a sample size of 74 would be necessary to detect a 10 mg difference in morphine equivalents totaled over the entire hospital stay. (Webster TM, Herrell SD, Chang SS, et al. The Journal of Urology 2005;174(3):912-914.||||0.39
72506632|NCT01797029|144545171|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Fisher Exact|||||||<0.0001
72506633|NCT00633139|144545202|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4013|TWO_SIDED||||||ANCOVA|||||||0.4013
72506634|NCT00633139|144545203|SUPERIORITY_OR_OTHER_LEGACY|||||||0.275|TWO_SIDED|95.0|||||ANCOVA|||||||0.2750
72506635|NCT00633139|144545204|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1363|TWO_SIDED|95.0|||||ANCOVA|||||||0.1363
72506636|NCT01522651|144545215|OTHER|Pairwise Comparative analysis|Percentage Difference|-19.8|STANDARD_ERROR_OF_MEAN|25.7||0.493|TWO_SIDED|95.0|-57.5|51.5||An equal-slopes analysis of covariance (ANCOVA) model was fitted to log-transformed AFB over 12 weeks, with baseline AFB as the covariate. AFB values \< 1% (\> 99%) were set to 1% (99%) before transformation.|ANCOVA|||||51.5|-57.5|0.493
72397860|NCT01313767|144301821|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.13||||0.7014|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Difference between groups in change from baseline to week 4 in carer burden scale of cleaning the armpit was compared using wilcoxon rank sum test.||||0.7014
72506637|NCT01522651|144545215|OTHER|Pairwise Comparative analysis|Percentage Difference|8.8|STANDARD_ERROR_OF_MEAN|32.9||0.78|TWO_SIDED|95.0|-40.2|98.2||An equal-slopes ANCOVA model was fitted to log-transformed AFB over 12 weeks, with baseline AFB as the covariate. AFB values \< 1% (\> 99%) were set to 1% (99%) before transformation.|ANCOVA|||||98.2|-40.2|0.780
72506638|NCT01522651|144545215|OTHER|Pairwise Comparative analysis|Percentage Difference|-57.0|STANDARD_ERROR_OF_MEAN|13.4||0.008|TWO_SIDED|95.0|-76.8|-20.1||An equal-slopes ANCOVA model was fitted to log-transformed AFB over 12 weeks, with baseline AFB as the covariate. AFB values \< 1% (\> 99%) were set to 1% (99%) before transformation.|ANCOVA|||||-20.1|-76.8|0.008
72506639|NCT01522651|144545215|OTHER|Pairwise Comparative analysis|Percentage Difference|-42.6|STANDARD_ERROR_OF_MEAN|17.5||0.072|TWO_SIDED|95.0|-68.7|5.2||An equal-slopes ANCOVA model was fitted to log-transformed AFB over 12 weeks, with baseline AFB as the covariate. AFB values \< 1% (\> 99%) were set to 1% (99%) before transformation.|ANCOVA|||||5.2|-68.7|0.072
72506640|NCT01522651|144545215|OTHER|Pairwise Comparative analysis||||||0.315||||||An equal-slopes ANCOVA model was fitted to log-transformed AFB over 12 weeks, with baseline AFB as the covariate. AFB values \< 1% (\> 99%) were set to 1% (99%) before transformation.|ANCOVA|||||||0.315
72506641|NCT01522651|144545215|OTHER|Pairwise Comparative analysis||||||0.049||||||An equal-slopes ANCOVA model was fitted to log-transformed AFB over 12 weeks, with baseline AFB as the covariate. AFB values \< 1% (\> 99%) were set to 1% (99%) before transformation.|ANCOVA|||||||0.049
72506642|NCT01522651|144545215|OTHER|Pairwise Comparative analysis||||||0.275||||||An equal-slopes ANCOVA model was fitted to log-transformed AFB over 12 weeks, with baseline AFB as the covariate. AFB values \< 1% (\> 99%) were set to 1% (99%) before transformation.|ANCOVA|||||||0.275
72506643|NCT01522651|144545215|OTHER|Pairwise Comparative analysis||||||0.002||||||An equal-slopes ANCOVA model was fitted to log-transformed AFB over 12 weeks, with baseline AFB as the covariate. AFB values \< 1% (\> 99%) were set to 1% (99%) before transformation.|ANCOVA|||||||0.002
72506644|NCT01522651|144545215|OTHER|Pairwise Comparative analysis||||||0.028||||||An equal-slopes ANCOVA model was fitted to log-transformed AFB over 12 weeks, with baseline AFB as the covariate. AFB values \< 1% (\> 99%) were set to 1% (99%) before transformation.|ANCOVA|||||||0.028
72506645|NCT01522651|144545215|OTHER|Pairwise Comparative analysis||||||0.334||||||An equal-slopes ANCOVA model was fitted to log-transformed AFB over 12 weeks, with baseline AFB as the covariate. AFB values \< 1% (\> 99%) were set to 1% (99%) before transformation.|ANCOVA|||||||0.334
72506646|NCT02658656|144545218|SUPERIORITY||Risk Ratio (RR)|0.91||||0.798|TWO_SIDED|95.0|0.45|1.85|||Chi-squared|||||1.85|.45|0.798
72506647|NCT02658656|144545219|SUPERIORITY||Risk Ratio (RR)|0.97||||0.935|TWO_SIDED|95.0|0.44|2.15|||Chi-squared|||||2.15|0.44|0.935
72506648|NCT02658656|144545220|SUPERIORITY||Risk Ratio (RR)|0.93||||0.829|TWO_SIDED|95.0|0.49|1.79|||Chi-squared|||||1.79|0.49|0.829
72506649|NCT02658656|144545221|SUPERIORITY||Risk Ratio (RR)|1.09||||0.809|TWO_SIDED|95.0|0.56|2.11|||Chi-squared|||||2.11|0.56|0.809
72506650|NCT02658656|144545222|SUPERIORITY||Risk Ratio (RR)|1.15||||0.717|TWO_SIDED|95.0|0.54|2.47|||Chi-squared|||||2.47|0.54|0.717
72506651|NCT02658656|144545223|SUPERIORITY||Risk Ratio (RR)|1.11||||0.738|TWO_SIDED|95.0|0.61|2.02|||Chi-squared|||||2.02|0.61|0.738
72506652|NCT01850563|144545264|OTHER||Hazard Ratio (HR)|0.87||||0.76|TWO_SIDED||||||Kaplan-Meier|||||||0.76
72506653|NCT01850563|144545266|OTHER||Hazard Ratio (HR)|0.82||||0.76|TWO_SIDED||||||Kaplan-Meier|||||||0.76
72506654|NCT03478878|144545281|SUPERIORITY||Mean Difference (Final Values)|1.83||||0.705|TWO_SIDED|95.0|-9.43|13.11||Result of statistical analyses were considered significant if the p-value from the two-sided test was \<0.05. No adjustments for multiplicity were made.|Student's paired t-test||The estimate was the difference in mean change in RIT between baseline and the treatment completion visit.|"Analysis: Student's paired t-test on study eyes alone at a two-sided Type I error rate of 5%.~Null hypothesis: the mean RIT at Baseline = the mean RIT at the treatment completion visit (Month 2 for Cohort 1)."||13.11|-9.43|0.705
72397861|NCT01313767|144301821|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.8884|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Difference between groups in change from baseline to week 8 in carer burden scale of cleaning the armpit was compared using wilcoxon rank sum test.||||0.8884
72397862|NCT01313767|144301821|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.27||||0.284|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Difference between groups in change from baseline to week 12 in carer burden scale of cleaning the armpit was compared using wilcoxon rank sum test.||||0.2840
72397863|NCT01287897|144301822|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.3|STANDARD_ERROR_OF_MEAN|10.5||0.3406|TWO_SIDED|90.0|-13.0|21.7||Type I rate was controlled for the 2 time points (Week 8 and Week 12) at 0.05 (one sided).|Generalized linear mixed model (GLMM)|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||||21.7|-13.0|0.3406
72397864|NCT01287897|144301822|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|18.7|STANDARD_ERROR_OF_MEAN|11.0||0.0438|TWO_SIDED|90.0|0.7|36.7||Type I rate was controlled for the 2 time points (Week 8 and Week 12) at 0.05 (one sided).|GLMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||||36.7|0.7|0.0438
72472559|NCT00477490|144468178|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.296||||0.2662|TWO_SIDED|95.0|0.821|2.05||The a priori statistically significant difference versus placebo is p≤0.05.|Regression, Logistic|Treatment difference and 95% CI were adjusted for age, absence/presence of nocturnal polyuria, and baseline number of nocturnal voids.||The trial was to be declared positive only if in the 100 μg group, a statistically significant positive effect as compared to placebo on both co-primaries was demonstrated. And only then, the next higher dose group (i.e., 50 μg) could be claimed superior to placebo, if it showed a statistically significant improvement over placebo on both co-primaries.||2.050|0.821|0.2662
72472560|NCT00477490|144468178|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.893|||<|0.0001|TWO_SIDED|95.0|1.795|4.715||The a priori statistically significant difference versus placebo is p≤0.05.|Regression, Logistic|Treatment difference and 95% CI were adjusted for age, absence/presence of nocturnal polyuria, and baseline number of nocturnal voids.||The trial was to be declared positive only if in the 100 μg group, a statistically significant positive effect as compared to placebo on both co-primaries was demonstrated. And only then, the next higher dose group (i.e., 50 μg) could be claimed superior to placebo, if it showed a statistically significant improvement over placebo on both co-primaries.||4.715|1.795|<0.0001
72472561|NCT00137969|144468189|SUPERIORITY_OR_OTHER|||||||0.4875||||||One-sided p-value.|Wilcoxon (Mann-Whitney)|||Stratified by randomization factors (race and initial prednisone dose)||||0.4875
72472562|NCT00137969|144468190|SUPERIORITY_OR_OTHER|||||||0.823|||||||Wilcoxon (Mann-Whitney)|||Stratified by randomization factors (race and initial prednisone dose)||||0.8230
72472563|NCT00137969|144468191|SUPERIORITY_OR_OTHER|||||||0.4318|||||||Cochran-Mantel-Haenszel|||Stratified by randomization factors (race and initial prednisone dose)||||0.4318
72472564|NCT00137969|144468192|SUPERIORITY_OR_OTHER|||||||0.9069|||||||Cochran-Mantel-Haenszel|||Stratified by randomization factors (race and initial prednisone dose)||||0.9069
72472565|NCT00137969|144468193|SUPERIORITY_OR_OTHER|||||||0.5602|||||||Cochran-Mantel-Haenszel|||Stratified by randomization factors (race and initial prednisone dose)||||0.5602
72472566|NCT00137969|144468194|SUPERIORITY_OR_OTHER|||||||0.8979|||||||Log Rank|||Stratified by randomization factors (race and initial prednisone dose)||||0.8979
72472567|NCT00137969|144468195|SUPERIORITY_OR_OTHER|||||||0.1277|||||||ANCOVA|||Stratified by randomization factors (race and initial prednisone dose)||||0.1277
72472568|NCT00137969|144468196|SUPERIORITY_OR_OTHER|||||||0.6202|||||||Cochran-Mantel-Haenszel|||Stratified by randomization factors (race and initial prednisone dose)||||0.6202
72472569|NCT01646177|144468204|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
72472570|NCT01646177|144468204|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
72472571|NCT01646177|144468204|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
72472572|NCT01646177|144468205|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
72472573|NCT01646177|144468205|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
72472574|NCT01646177|144468205|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
72472575|NCT01646177|144468206|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
72472576|NCT01646177|144468206|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
72472577|NCT01646177|144468206|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
72472578|NCT01646177|144468207|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
72472579|NCT01646177|144468207|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
72472580|NCT01646177|144468207|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
72472581|NCT01646177|144468208|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
72472582|NCT01646177|144468208|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
72472583|NCT01646177|144468208|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
72472584|NCT01646177|144468209|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
72472585|NCT01646177|144468209|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
72472586|NCT01646177|144468209|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
72472587|NCT01646177|144468210|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
72472588|NCT01646177|144468210|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
72472589|NCT01646177|144468210|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
72472590|NCT01646177|144468211|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
72472591|NCT01646177|144468211|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
72472592|NCT01646177|144468211|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
72397865|NCT01287897|144301823|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.2|STANDARD_ERROR_OF_MEAN|13.6||0.2258|TWO_SIDED|90.0|-12.1|32.6||Type I rate was controlled for the 2 time points (Week 8 and Week 12) at 0.05 (one sided).|GLMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||||32.6|-12.1|0.2258
72397866|NCT01287897|144301824|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.7|STANDARD_ERROR_OF_MEAN|10.5||0.2627|TWO_SIDED|90.0|-10.6|23.9||Type I rate was controlled for the 2 time points (Week 8 and Week 12) at 0.05 (one sided).|GLMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||||23.9|-10.6|0.2627
72397867|NCT01287897|144301824|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|18.8|STANDARD_ERROR_OF_MEAN|10.9||0.0425|TWO_SIDED|90.0|0.8|36.7||Type I rate was controlled for the 2 time points (Week 8 and Week 12) at 0.05 (one sided).|GLMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||||36.7|0.8|0.0425
72472593|NCT01646177|144468212|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
72472594|NCT01646177|144468212|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
72472595|NCT01646177|144468212|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
72472596|NCT01646177|144468213|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
72472597|NCT01646177|144468213|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
72472598|NCT01646177|144468213|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
72472599|NCT01646177|144468214|SUPERIORITY_OR_OTHER_LEGACY|||||||0.473|TWO_SIDED||||||ANCOVA|||||||0.473
72472600|NCT01646177|144468214|SUPERIORITY_OR_OTHER_LEGACY|||||||0.015|TWO_SIDED||||||ANCOVA|||||||0.015
72472601|NCT01646177|144468214|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||ANCOVA|||||||<0.001
72472602|NCT01646177|144468215|SUPERIORITY_OR_OTHER_LEGACY|||||||0.006|TWO_SIDED||||||ANCOVA|||Includes analysis only from Absenteeism Score.||||0.006
72472603|NCT01646177|144468215|SUPERIORITY_OR_OTHER_LEGACY|||||||0.045|TWO_SIDED||||||ANCOVA|||Includes analysis only from Absenteeism Score.||||0.045
72472604|NCT01646177|144468215|SUPERIORITY_OR_OTHER_LEGACY|||||||0.012|TWO_SIDED||||||ANCOVA|||Includes analysis only from Absenteeism Score.||||0.012
72472605|NCT01646177|144468215|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||ANCOVA|||Includes analysis only from Activity Impairment Score.||||<0.001
72472606|NCT01646177|144468215|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||ANCOVA|||Includes analysis only from Activity Impairment Score.||||<0.001
72397868|NCT01287897|144301825|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|15.1|STANDARD_ERROR_OF_MEAN|13.7||0.1362|TWO_SIDED|90.0|-7.5|37.6||Type I rate was controlled for the 2 time points (Week 8 and Week 12) at 0.05 (one sided).|GLMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||||37.6|-7.5|0.1362
72472607|NCT01646177|144468215|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||ANCOVA|||Includes analysis only from Activity Impairment Score.||||<0.001
72472608|NCT01646177|144468215|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||ANCOVA|||Includes analysis only from Presenteeism Score.||||<0.001
72472609|NCT01646177|144468215|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||ANCOVA|||Includes analysis only from Presenteeism Score.||||<0.001
72472610|NCT01646177|144468215|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||ANCOVA|||Includes analysis only from Presenteeism Score.||||<0.001
72472611|NCT01646177|144468215|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||ANCOVA|||Includes analysis only from Work Productively Loss Score.||||<0.001
72472612|NCT01646177|144468215|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||ANCOVA|||Includes analysis only from Work Productively Loss Score.||||<0.001
72472613|NCT01646177|144468215|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||ANCOVA|||Includes analysis only from Work Productively Loss Score.||||<0.001
72472614|NCT01646177|144468216|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||ANCOVA|||Includes analysis only from PCS.||||<0.001
72472615|NCT01646177|144468216|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||ANCOVA|||Includes analysis only from PCS.||||<0.001
72472616|NCT01646177|144468216|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||ANCOVA|||Includes analysis only from PCS.||||<0.001
72472617|NCT01646177|144468216|SUPERIORITY_OR_OTHER_LEGACY|||||||0.031|TWO_SIDED||||||ANCOVA|||Includes analysis only from MCS.||||0.031
72472618|NCT01646177|144468216|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||ANCOVA|||Includes analysis only from MCS.||||<0.001
72472619|NCT01646177|144468216|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||ANCOVA|||Includes analysis only from MCS.||||<0.001
72472620|NCT01646177|144468217|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
72472621|NCT01646177|144468217|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
72472622|NCT01646177|144468217|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
72472623|NCT01646177|144468218|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
72472624|NCT01646177|144468218|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
72472625|NCT01646177|144468218|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
72472626|NCT01646177|144468219|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
72472627|NCT01646177|144468219|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
72472628|NCT01646177|144468219|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
72472629|NCT01646177|144468220|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
72472630|NCT01646177|144468220|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
72472631|NCT01646177|144468220|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
72472632|NCT01465763|144468222|SUPERIORITY_OR_OTHER||Percent Difference|10.3||||0.007|TWO_SIDED|95.0|4.3|16.3|||CMH Chi-square test|||P-value based on Cochran-Mantel-Haenszel (CMH) chi-square test stratified by prior treatment with anti-tumor necrosis factor (TNF), steroid use at baseline and geographic region. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using Non-responder imputation (NRI).||16.3|4.3|0.0070
72472633|NCT01465763|144468223|SUPERIORITY_OR_OTHER||Percent Difference|15.7||||0.0005|TWO_SIDED|95.0|8.1|23.4|||CMH Chi-square test|||P-value based on CMH chi-square test stratified by prior treatment with anti-TNF, steroid use at baseline and geographic region. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||23.4|8.1|0.0005
72472634|NCT01465763|144468224|SUPERIORITY_OR_OTHER||Percent Difference|27.1|||<|0.0001|TWO_SIDED|95.0|17.7|36.5|||CMH Chi-square test|||P-value based on CMH chi-square test stratified by prior treatment with anti-TNF, steroid use at baseline and geographic region. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||36.5|17.7|<0.0001
72472635|NCT01465763|144468225|SUPERIORITY_OR_OTHER||Percent Difference|5.1||||0.0345|TWO_SIDED|95.0|1.9|8.3|||CMH Chi-square test|||P-value based on CMH chi-square test stratified by prior treatment with anti-TNF, steroid use at baseline and geographic region. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||8.3|1.9|0.0345
72472636|NCT01465763|144468226|SUPERIORITY_OR_OTHER||Percent Difference|10.3||||0.007|TWO_SIDED|95.0|4.3|16.3|||CMH Chi-square test|||P-value based on CMH chi-square test stratified by prior treatment with anti-TNF, steroid use at baseline and geographic region. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||16.3|4.3|0.0070
72472637|NCT01465763|144468227|SUPERIORITY_OR_OTHER||Percent Difference|6.0||||0.0601|TWO_SIDED|95.0|1.0|11.1|||CMH Chi-square test|||P-value based on CMH chi-square test stratified by prior treatment with anti-TNF, steroid use at baseline and geographic region. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||11.1|1.0|0.0601
72472638|NCT01465763|144468228|SUPERIORITY_OR_OTHER||Percent Difference|6.5||||0.0043|TWO_SIDED|95.0|4.3|8.7|||CMH Chi-square test|||P-value based on CMH chi-square test stratified by prior treatment with anti-TNF, steroid use at baseline and geographic region. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||8.7|4.3|0.0043
72472639|NCT01465763|144468230|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001|TWO_SIDED|95.0|-1.3|-0.5|||Mixed-Effects Model|||At Week 2: The change from baseline was analyzed using mixed effect model with treatment group, prior treatment with antiTNF, steroid use at baseline, geographic region, visit and visit by treatment group all as fixed effects, and participants as a random effect.||-0.5|-1.3|<0.0001
72472640|NCT01465763|144468230|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001|TWO_SIDED|95.0|-1.5|-0.7|||Mixed-Effects Model|||At Week 4: The change from baseline was analyzed using mixed effect model with treatment group, prior treatment with antiTNF, steroid use at baseline, geographic region, visit and visit by treatment group all as fixed effects, and participants as a random effect.||-0.7|-1.5|<0.0001
72472641|NCT01465763|144468230|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-1.5|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001|TWO_SIDED|95.0|-1.9|-1.1|||Mixed-Effects Model|||At Week 8: The change from baseline was analyzed using mixed effect model with treatment group, prior treatment with antiTNF, steroid use at baseline, geographic region, visit and visit by treatment group all as fixed effects, and participants as a random effect.||-1.1|-1.9|<0.0001
72565804|NCT02709486|144662704|SUPERIORITY||Least Square Mean Difference|-0.69|STANDARD_ERROR_OF_MEAN|0.15|<|0.0001|TWO_SIDED|95.0|-0.99|-0.39|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.||-0.39|-0.99|<.0001
72397869|NCT01287897|144301826|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.1|STANDARD_ERROR_OF_MEAN|7.0||0.1527|TWO_SIDED|90.0|-4.3|18.6|||GLMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in CDAI-70 response rate for the 10-mg arm at Week 2.||18.6|-4.3|0.1527
72472642|NCT01465763|144468231|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-1.9|STANDARD_ERROR_OF_MEAN|0.3|<|0.0001|TWO_SIDED|95.0|-2.5|-1.4|||ANCOVA|||The change from Baseline at Week 8 was analyzed using an analysis of covariance (ANCOVA) model with treatment group, prior treatment with anti-TNF, steroid use at baseline and geographic region as factors and baseline as a covariate based on the observed-case data.||-1.4|-2.5|<0.0001
72472643|NCT01711853|144468252|SUPERIORITY_OR_OTHER|||||||0.5186|TWO_SIDED||||||ANOVA|ANOVA model on the logarithmic scale; effects accounting for the following sources of variation: 'gender', 'age group', and 'renal function group'.||"Patients were classified into groups for renal function based on the median values for renal function (1: ≤ median GFR (Glomerular filtration rate), 2: \> median GFR).~Median is calculated based on trial data of treated set"||||0.5186
72472644|NCT01711853|144468252|SUPERIORITY_OR_OTHER|||||||0.9883|TWO_SIDED||||||ANOVA|ANOVA model on the logarithmic scale; effects accounting for the following sources of variation: 'gender', 'age group', and 'renal function group'.||"Patients were classified into groups for renal function based on the median values for renal function (1: ≤ median age, 2: \> median age).~Median is calculated based on trial data of treated set"||||0.9883
72472645|NCT01711853|144468252|SUPERIORITY_OR_OTHER|||||||0.7853|TWO_SIDED||||||ANOVA|ANOVA model on the logarithmic scale; effects accounting for the following sources of variation: 'gender', 'age group', and 'renal function group'.||Patients were classified based on the gender distribution.||||0.7853
72565805|NCT02709486|144662704|SUPERIORITY||Least Square Mean Difference|-0.57|STANDARD_ERROR_OF_MEAN|0.15||0.0002|TWO_SIDED|95.0|-0.87|-0.27|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.||-0.27|-0.87|0.0002
72397870|NCT01287897|144301826|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|18.1|STANDARD_ERROR_OF_MEAN|9.1||0.0235|TWO_SIDED|90.0|3.1|33.2|||GLMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in CDAI-70 response rate for the 10-mg arm at Week 4.||33.2|3.1|0.0235
72397871|NCT01287897|144301826|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.9|STANDARD_ERROR_OF_MEAN|9.9||0.0792|TWO_SIDED|90.0|-2.3|30.2|||GLMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in CDAI-70 response rate for the 10-mg arm at Week 6.||30.2|-2.3|0.0792
72472646|NCT01711853|144468253|SUPERIORITY_OR_OTHER|||||||0.4692|TWO_SIDED||||||ANOVA|ANOVA model on the logarithmic scale; effects accounting for the following sources of variation: 'gender', 'age group', and 'renal function group'.||"Patients were classified into groups for renal function based on the median values for renal function (1: ≤ median GFR, 2: \> median GFR).~Median is calculated based on trial data of treated set"||||0.4692
72472647|NCT01711853|144468253|SUPERIORITY_OR_OTHER|||||||0.9734|TWO_SIDED||||||ANOVA|ANOVA model on the logarithmic scale; effects accounting for the following sources of variation: 'gender', 'age group', and 'renal function group'.||"Patients were classified into groups for renal function based on the median values for renal function (1: ≤ median age, 2: \> median age).~Median is calculated based on trial data of treated set"||||0.9734
72472648|NCT01711853|144468253|SUPERIORITY_OR_OTHER|||||||0.9201|TWO_SIDED||||||ANOVA|ANOVA model on the logarithmic scale; effects accounting for the following sources of variation: 'gender', 'age group', and 'renal function group'.||Patients were classified based on the gender distribution.||||0.9201
72472649|NCT02992691|144468269|OTHER||Mean Difference (Net)|-0.01||||0.6674|TWO_SIDED|95.0|-0.06|0.04||From ANCOVA analysis for change from pre-brushing with treatment and period as fixed effect, participant as random effect, participant-level baseline and period level minus participant-level baseline as covariates.|ANCOVA|||This comparison was tested under a null hypothesis of no difference against alternative hypothesis of a difference between treatments||0.04|-0.06|0.6674
72472650|NCT00392925|144468300|SUPERIORITY_OR_OTHER|||||||0.0004|||||||ANCOVA|||Based on an Analysis of Covariance model including factors for treatment group, sex, enrollment body mass index (BMI) category, lead-in body weight loss category, and baseline (Day 1) weight as a covariate. The p-value is for testing the null hypothesis of no difference between treatments. Analysis performed two-sided at a 5% significance level to compare treatment groups.||||0.0004
72472651|NCT00755105|144468328|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||ANOVA|||||||< 0.05
72472652|NCT01281839|144468329|SUPERIORITY_OR_OTHER||Difference in proportions of SVR12|43.8|||<|0.001|TWO_SIDED|95.0|34.6|53.0|||Cochran-Mantel-Haenszel|||Null hypothesis: There is no difference in proportions of SVR12 between the treatment groups.||53.0|34.6|<0.001
72472653|NCT01281839|144468330|SUPERIORITY_OR_OTHER||Difference in proportions of SVR72|43.3|||<|0.001|TWO_SIDED|95.0|34.1|52.5|||Cochran-Mantel-Haenszel|||Null hypothesis: There is no difference in proportions of SVR72 between the treatment groups.||52.5|34.1|<0.001
72472654|NCT01281839|144468331|SUPERIORITY_OR_OTHER||Difference in proportions of SVR24|44.1|||<|0.001|TWO_SIDED|95.0|34.9|53.2|||Cochran-Mantel-Haenszel|||There is no difference in proportions of SVR24 between the treatment groups.||53.2|34.9|<0.001
72472655|NCT01281839|144468332|SUPERIORITY_OR_OTHER||Difference in proportions of SVR4|41.0|||<|0.001|TWO_SIDED|95.0|32.1|49.9|||Cochran-Mantel-Haenszel|||There is no difference in proportions of SVR24 between the treatment groups.||49.9|32.1|<0.001
72472656|NCT00402051|144468371|SUPERIORITY_OR_OTHER||6-Month PFS Rate|52.8|||||TWO_SIDED|95.0|40.3|65.3||||||Hypothesis testing was done independently for each treatment arm (no direct treatment group comparison).||65.3|40.3|
72472657|NCT00402051|144468371|SUPERIORITY_OR_OTHER||6-Month PFS Rate|39.3|||||TWO_SIDED|95.0|27.8|50.8||||||Hypothesis testing was done independently for each treatment arm (no direct treatment group comparison).||50.8|27.8|
72472658|NCT00402051|144468373|SUPERIORITY_OR_OTHER||Best Overall Response Rate (%)|32.3||||||95.0|21.2|45.1||||||Response rates were evaluated separately for each treatment arm||45.1|21.2|
72472659|NCT00402051|144468373|SUPERIORITY_OR_OTHER||Best Overall Response Rate (%)|20.0||||||95.0|11.1|31.8||||||Response rates were evaluated separately for each treatment arm||31.8|11.1|
72397872|NCT01287897|144301826|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.6|STANDARD_ERROR_OF_MEAN|11.0||0.1909||90.0|-8.4|27.6|||GLMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in CDAI-70 response rate for the 10-mg arm at Week 10.||27.6|-8.4|0.1909
72397873|NCT01287897|144301826|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.8|STANDARD_ERROR_OF_MEAN|6.8||0.1981|TWO_SIDED|90.0|-5.4|17.0|||GLMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in CDAI-70 response rate for the 50-mg arm at Week 2.||17.0|-5.4|0.1981
72397874|NCT01287897|144301826|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|20.6|STANDARD_ERROR_OF_MEAN|9.3||0.0132|TWO_SIDED|90.0|5.3|35.8|||GLMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in CDAI-70 response rate for the 50-mg arm at Week 4.||35.8|5.3|0.0132
72397875|NCT01287897|144301826|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|25.1|STANDARD_ERROR_OF_MEAN|10.1||0.0063|TWO_SIDED|90.0|8.6|41.7|||GLMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in CDAI-70 response rate for the 50-mg arm at Week 6.||41.7|8.6|0.0063
72397876|NCT01287897|144301826|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|24.7|STANDARD_ERROR_OF_MEAN|11.2||0.0138|TWO_SIDED|90.0|6.2|43.1|||GLMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in CDAI-70 response rate for the 50-mg arm at Week 10.||43.1|6.2|0.0138
72472660|NCT01791972|144468395|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.2|STANDARD_ERROR_OF_MEAN|1.982|<|0.0001|TWO_SIDED|95.0|-20.19|-12.14||Significance level is 0.05.|mixed-effect analysis of covariance|Fixed effects of sequence, trt group, period, and center, within period baseline FEV1 as a covariate, and random effect for patient within sequence.||||-12.14|-20.19|<0.0001
72397877|NCT01287897|144301827|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|15.4|STANDARD_ERROR_OF_MEAN|10.2||0.0662|TWO_SIDED|90.0|-1.4|32.1|||GLMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in CDAI-70 response rate for the 200-mg arm at Week 2.||32.1|-1.4|0.0662
72397878|NCT01287897|144301827|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.5|STANDARD_ERROR_OF_MEAN|10.0||0.1708|TWO_SIDED|90.0|-6.9|25.8|||GLMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in CDAI-70 response rate for the 200-mg arm at Week 4.||25.8|-6.9|0.1708
72472661|NCT01791972|144468396|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.68|STANDARD_ERROR_OF_MEAN|0.075|<|0.0001|TWO_SIDED|95.0|0.53|0.84||Terms for treatment and period, computed with the generalized estimating equations (GEE) algorithm, which adjusts for potential correlation between measurements on the same patient. Significance level of 0.05.|Regression, Logistic|||||0.84|0.53|<0.0001
72472662|NCT00630734|144468401|SUPERIORITY_OR_OTHER|||||||0.43||95.0||||Threshold of significance was P\<0.05.|ANOVA|||Relative change data were compared between SLCO1B1 diplotype groups using one-way ANOVA (with post-hoc Bonferroni tests).||||0.43
72472663|NCT00630734|144468402|SUPERIORITY_OR_OTHER|||||||0.28||95.0|||||ANOVA|||||||0.28
72472664|NCT00630734|144468403|SUPERIORITY_OR_OTHER|||||||0.66||95.0|||||ANOVA|||||||0.66
72472665|NCT00630734|144468404|SUPERIORITY_OR_OTHER|||||||0.85||95.0|||||ANOVA|||||||0.85
72472666|NCT00630734|144468405|SUPERIORITY_OR_OTHER|||||||0.11||95.0|||||ANOVA|||||||0.11
72472667|NCT00630734|144468406|SUPERIORITY_OR_OTHER|||||||0.15||95.0|||||ANOVA|||||||0.15
72472668|NCT00630734|144468407|SUPERIORITY_OR_OTHER|||||||0.22||95.0|||||ANOVA|||||||0.22
72472669|NCT00630734|144468408|SUPERIORITY_OR_OTHER|||||||0.67||95.0|||||ANOVA|||||||0.67
72472670|NCT00630734|144468409|SUPERIORITY_OR_OTHER|||||||0.006||95.0|||||ANOVA|||||||0.006
72472671|NCT00630734|144468410|SUPERIORITY_OR_OTHER|||||||0.08||95.0|||||ANOVA|||||||0.08
72472672|NCT06152224|144468431|EQUIVALENCE|Power analysis was determined based on a 3 point improvement on the Vaizey score in both groups. With an allowable difference of 1 point between randomized groups, type I error level = 0.05, power = 0.8, and standard deviation of outcome of 4.|Mean Difference (Final Values)|-3.0|STANDARD_DEVIATION|4.0||0.918|TWO_SIDED|||||a priori threshold 0.05|t-test, 2 sided|continuous outcome||change from baseline||||0.918
72472673|NCT06152224|144468436|EQUIVALENCE|Power analysis was determined based on a 3 point improvement on the Vaizey score in both groups. With an allowable difference of 1 point between randomized groups, type I error level = 0.05, power = 0.8, and standard deviation of outcome of 4.||||||0.801||||||a prior threshold 0.05|t-test, 2 sided|continuous outcome||change from baseline||||0.801
72472674|NCT06152224|144468436|EQUIVALENCE|Power analysis was determined based on a 3 point improvement on the Vaizey score in both groups. With an allowable difference of 1 point between randomized groups, type I error level = 0.05, power = 0.8, and standard deviation of outcome of 4.||||||0.317||||||a priori threshold 0.05|t-test, 2 sided|continuous outcome||change from baseline||||0.317
72472675|NCT06152224|144468437|EQUIVALENCE|Power analysis was determined based on a 3 point improvement on the Vaizey score in both groups. With an allowable difference of 1 point between randomized groups, type I error level = 0.05, power = 0.8, and standard deviation of outcome of 4.|||||<|0.001||||||a prior threshold 0.05|t-test, 2 sided|continuous outcome||change from baseline Brink Score: Pressure||||<0.001
72472676|NCT06152224|144468437|EQUIVALENCE|Power analysis was determined based on a 3 point improvement on the Vaizey score in both groups. With an allowable difference of 1 point between randomized groups, type I error level = 0.05, power = 0.8, and standard deviation of outcome of 4.|||||<|0.001||||||a prior threshold 0.05|t-test, 2 sided|continuous outcome||change from baseline in Brink Score: Pressure||||<0.001
72472677|NCT06152224|144468438|EQUIVALENCE|Power analysis was determined based on a 3 point improvement on the Vaizey score in both groups. With an allowable difference of 1 point between randomized groups, type I error level = 0.05, power = 0.8, and standard deviation of outcome of 4.|||||<|0.001||||||a prior threshold 0.05|t-test, 2 sided|continuous outcome||Change from baseline in Brink Score: Vertical Displacement||||<0.001
72472678|NCT06152224|144468438|EQUIVALENCE|Power analysis was determined based on a 3 point improvement on the Vaizey score in both groups. With an allowable difference of 1 point between randomized groups, type I error level = 0.05, power = 0.8, and standard deviation of outcome of 4.|||||<|0.001||||||a prior threshold 0.05|t-test, 2 sided|continuous outcome||change from baseline in Brink Score: Vertical Displacement||||<0.001
72472679|NCT06152224|144468439|EQUIVALENCE|Power analysis was determined based on a 3 point improvement on the Vaizey score in both groups. With an allowable difference of 1 point between randomized groups, type I error level = 0.05, power = 0.8, and standard deviation of outcome of 4.|||||<|0.001||||||a prior threshold 0.05|t-test, 2 sided|continuous outcome||change from baseline in Brink Score: Duration Contraction||||<0.001
72472680|NCT06152224|144468439|EQUIVALENCE|Power analysis was determined based on a 3 point improvement on the Vaizey score in both groups. With an allowable difference of 1 point between randomized groups, type I error level = 0.05, power = 0.8, and standard deviation of outcome of 4.|||||<|0.001||||||a prior threshold 0.05|t-test, 2 sided|continuous outcome||change from baseline in Brink Score: Duration Contraction||||<0.001
72472681|NCT06152224|144468449|EQUIVALENCE|Power analysis was determined based on a 3 point improvement on the Vaizey score in both groups. With an allowable difference of 1 point between randomized groups, type I error level = 0.05, power = 0.8, and standard deviation of outcome of 4.||||||0.035||||||a prior threshold 0.05|t-test, 2 sided|continuous outcome||Q1. The app was easy to use||||0.035
72472682|NCT06152224|144468449|EQUIVALENCE|Power analysis was determined based on a 3 point improvement on the Vaizey score in both groups. With an allowable difference of 1 point between randomized groups, type I error level = 0.05, power = 0.8, and standard deviation of outcome of 4.||||||0.063||||||a prior threshold 0.05|t-test, 2 sided|continuous outcome||Q2. It was easy for me to learn to use the app||||0.063
72472683|NCT06152224|144468449|EQUIVALENCE|Power analysis was determined based on a 3 point improvement on the Vaizey score in both groups. With an allowable difference of 1 point between randomized groups, type I error level = 0.05, power = 0.8, and standard deviation of outcome of 4.||||||0.587||||||a prior threshold 0.05|t-test, 2 sided|continuous outcome||Q11. I would use this app again||||0.587
72565806|NCT02709486|144662704|SUPERIORITY||Least Square Mean Difference|-0.97|STANDARD_ERROR_OF_MEAN|0.16|<|0.0001|TWO_SIDED|95.0|-1.29|-0.65|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.||-0.65|-1.29|<.0001
72623027|NCT01299961|144776388|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.2|STANDARD_DEVIATION|3.7||0.19|TWO_SIDED||||||t-test, 2 sided|||7 joints were scanned by grey-scale ultra sound of the most affected side: wrist, MCP 2/3, PIP 2/3, and MTP 2/5. GSUS was scored semi-quantitatively on a scale of 0-3 (higher score is worse). The mean score of the 2-3 views obtained for each joint was added across all 7 joints, and the total GSUS (range 0-21) scores were calculated. The change from baseline to 12 months is calculated as the baseline GSUS minus 12 month GSUS.||||0.19
72472684|NCT06152224|144468449|EQUIVALENCE|Power analysis was determined based on a 3 point improvement on the Vaizey score in both groups. With an allowable difference of 1 point between randomized groups, type I error level = 0.05, power = 0.8, and standard deviation of outcome of 4.||||||0.107||||||a prior threshold 0.05|t-test, 2 sided|continuous outcome||Q12. Overall, I am satisfied with this app||||0.107
72472685|NCT06152224|144468449|EQUIVALENCE|Power analysis was determined based on a 3 point improvement on the Vaizey score in both groups. With an allowable difference of 1 point between randomized groups, type I error level = 0.05, power = 0.8, and standard deviation of outcome of 4.||||||0.486||||||a prior threshold 0.05|t-test, 2 sided|continuous outcome||Q15. The app helped me manage my health effectively||||0.486
72472686|NCT02755129|144468465|OTHER||||||||||||||||||"To assess the similarity between the Reveal LINQ measures and those from the reference system, correlation coefficients were used.~The correlation coefficient was calculated over windows of 4 seconds and averaged for each exercise. Then, the average correlation coefficient over all patients and exercise was calculated."|||
72472687|NCT02614183|144468572|SUPERIORITY||Mean Difference (Final Values)|-1.92|STANDARD_ERROR_OF_MEAN|0.28|<|0.001|TWO_SIDED|95.0|-2.48|-1.37|||Mixed Models Analysis|||||-1.37|-2.48|<.001
72472688|NCT02614183|144468572|SUPERIORITY||Mean Difference (Final Values)|-1.76|STANDARD_ERROR_OF_MEAN|0.28|<|0.001|TWO_SIDED|95.0|-2.31|-1.2|||Mixed Models Analysis|||||-1.20|-2.31|<.001
72472689|NCT02614183|144468573|SUPERIORITY||Odds Ratio (OR)|2.63|||||TWO_SIDED|95.0|2.05|3.37||||||Reduction from Baseline ≥50%||3.37|2.05|
72472690|NCT02614183|144468573|SUPERIORITY||Odds Ratio (OR)|2.48|||||TWO_SIDED|95.0|1.94|3.18||||||Reduction from Baseline ≥50%||3.18|1.94|
72472691|NCT02614183|144468573|SUPERIORITY||Odds Ratio (OR)|2.65|||||TWO_SIDED|95.0|2.04|3.45||||||Reduction from Baseline ≥75%||3.45|2.04|
72472692|NCT02614183|144468573|SUPERIORITY||Odds Ratio (OR)|2.62|||||TWO_SIDED|95.0|2.01|3.41||||||Reduction from Baseline ≥75%||3.41|2.01|
72472693|NCT02614183|144468573|SUPERIORITY||Odds Ratio (OR)|2.8|||||TWO_SIDED|95.0|1.96|4.01||||||Reduction from Baseline = 100%||4.01|1.96|
72472694|NCT02614183|144468573|SUPERIORITY||Odds Ratio (OR)|2.61|||||TWO_SIDED|95.0|1.81|3.75||||||Reduction from Baseline = 100%||3.75|1.81|
72472695|NCT02614183|144468574|SUPERIORITY||Mean Difference (Final Values)|7.74|STANDARD_ERROR_OF_MEAN|1.29|<|0.001|TWO_SIDED|95.0|5.2|10.28|||Mixed Models Analysis|||||10.28|5.20|<.001
72472696|NCT02614183|144468574|SUPERIORITY||Mean Difference (Final Values)|7.4|STANDARD_ERROR_OF_MEAN|1.31|<|0.001|TWO_SIDED|95.0|4.83|9.97|||Mixed Models Analysis|||||9.97|4.83|<.001
72472697|NCT02614183|144468575|SUPERIORITY||Mean Difference (Final Values)|-1.81|STANDARD_ERROR_OF_MEAN|0.24|<|0.001|TWO_SIDED|95.0|-2.28|-1.33|||Mixed Models Analysis|||||-1.33|-2.28|<.001
72472698|NCT02614183|144468575|SUPERIORITY||Odds Ratio (OR)|-1.61|STANDARD_ERROR_OF_MEAN|0.26|<|0.001|TWO_SIDED|95.0|-2.09|-1.14|||Mixed Models Analysis|||||-1.14|-2.09|<.001
72472699|NCT02614183|144468576|SUPERIORITY||Mean Difference (Final Values)|-0.32|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.52|-0.12|||Mixed Models Analysis|||||-0.12|-0.52|<.001
72472700|NCT02614183|144468576|SUPERIORITY||Mean Difference (Final Values)|-0.28|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.48|-0.07|||Mixed Models Analysis|||||-0.07|-0.48|<.001
72472701|NCT02614183|144468577|SUPERIORITY||Mean Difference (Final Values)|-13.98|STANDARD_ERROR_OF_MEAN|2.55|<|0.001|TWO_SIDED|95.0|-18.99|-8.97|||Mixed Models Analysis|||||-8.97|-18.99|<.001
72472702|NCT02614183|144468577|SUPERIORITY||Mean Difference (Final Values)|-13.64|STANDARD_ERROR_OF_MEAN|2.57|<|0.001|TWO_SIDED|95.0|-18.68|-8.6|||Mixed Models Analysis|||||-8.60|-18.68|<.001
72472703|NCT02614183|144468578|SUPERIORITY||Mean Difference (Final Values)|-6.29|STANDARD_ERROR_OF_MEAN|1.61|<|0.001|TWO_SIDED|95.0|-9.45|-3.13|||Mixed Models Analysis|||||-3.13|-9.45|<.001
72472704|NCT02614183|144468578|SUPERIORITY||Mean Difference (Final Values)|-5.19|STANDARD_ERROR_OF_MEAN|1.63|<|0.001|TWO_SIDED|95.0|-8.39|-1.98|||Mixed Models Analysis|||||-1.98|-8.39|<.001
72472705|NCT02614183|144468579|SUPERIORITY||||||<|0.16|||||||Fisher Exact|||TE ADA Positive.||||<.160
72472706|NCT02614183|144468579|SUPERIORITY|||||||0.02|||||||Fisher Exact|||TE ADA Positive.||||.020
72472707|NCT02614183|144468579|SUPERIORITY|||||||0.131|||||||Fisher Exact|||Neutralizing Antibodies.||||.131
72472708|NCT02614183|144468579|SUPERIORITY|||||||0.009|||||||Fisher Exact|||Neutralizing Antibodies.||||.009
72472709|NCT01088984|144468585|SUPERIORITY_OR_OTHER|||||||1||||||1-sided p-value is calculated against the null hypothesis of a response rate of 5%.|binomial parameter exact method|||||||1.0000
72472710|NCT01006980|144468618|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.37|||<|0.0001|TWO_SIDED|95.0|0.26|0.55|||Log Rank||The hazard ratio for death for vemurafenib relative to dacarbazine and the associated 95% confidence interval were computed using an unstratified Cox regression model.|The trial had a power of 80% to detect a hazard ratio of 0.65 for overall survival with an alpha level of 0.045 (an increase in median survival from 8 months for dacarbazine to 12.3 months for vemurafenib), one interim analysis for overall survival at 50% information.||0.55|0.26|<0.0001
72472711|NCT01006980|144468619|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.26|||<|0.0001|TWO_SIDED|95.0|0.2|0.33|||Log Rank||Hazard ratios for treatment with vemurafenib, as compared with dacarbazine, were estimated with the use of unstratified Cox regression.|The trial had a power of 90% to detect a hazard ratio of 0.55 for progression-free survival with an alpha level of 0.005 (an increase in median survival from 2.5 months for dacarbazine to 4.5 months for vemurafenib).||0.33|0.20|<.0001
72506655|NCT03478878|144545281|SUPERIORITY||Mean Difference (Final Values)|1.8||||0.577|TWO_SIDED|95.0|-27.43|31.02||Result of statistical analyses were considered significant if the p-value from the two-sided test was \<0.05. No adjustments for multiplicity were made.|Student's paired t-test||The estimate was the difference in mean change in RIT between baseline and the treatment completion visit.|"Analysis: Student's paired t-test on study eyes alone at a two-sided Type I error rate of 5%.~Null hypothesis: the mean RIT at Baseline = the mean RIT at the treatment completion visit (Month 1 for Cohort 2)."||31.02|-27.43|0.577
72506656|NCT03478878|144545282|SUPERIORITY||Mean Difference (Final Values)|1.87||||0.646|TWO_SIDED|95.0|-7.6|11.35||Result of statistical analyses were considered significant if the p-value from the two-sided test was \<0.05. No adjustments for multiplicity were made.|Student's paired t-test||The estimate was the difference in mean change in RIT between baseline and the treatment completion visit.|"Analysis: Student's paired t-test on study eyes alone at a two-sided Type I error rate of 5%.~Null hypothesis: the mean RIT at Baseline = the mean RIT at the post-treatment follow-up visit (Month 3 for Cohort 1)."||11.35|-7.60|0.646
72506657|NCT03478878|144545282|SUPERIORITY||Mean Difference (Final Values)|2.3||||0.405|TWO_SIDED|95.0|-19.3|23.9||Result of statistical analyses were considered significant if the p-value from the two-sided test was \<0.05. No adjustments for multiplicity were made.|Student's paired t-test||The estimate was the difference in mean change in RIT between baseline and the treatment completion visit.|"Analysis: Student's paired t-test on study eyes alone at a two-sided Type I error rate of 5%.~Null hypothesis: the mean RIT at Baseline = the mean RIT at the post-treatment follow-up visit (Month 2 for Cohort 2)."||23.90|-19.30|0.405
72506658|NCT02778867|144545311|OTHER|||||||0.58||||||α \< 0.05|Fisher Exact|Two-sided||||||0.58
72506659|NCT02778867|144545312|OTHER|||||||0.06||||||α \< 0.05|Fisher Exact|Two sided||||||0.06
72506660|NCT02778867|144545315|OTHER|||||||0.9||||||α \< 0.05|Wilcoxon (Mann-Whitney)|||||||0.90
72506661|NCT02778867|144545316|OTHER|||||||0.22||||||α \< 0.05|t-test, 2 sided|Two sample t-test||||||0.22
72506662|NCT02778867|144545317|OTHER|||||||0.71||||||α \< 0.05|Wilcoxon (Mann-Whitney)|||||||0.71
72472712|NCT01182441|144468665|SUPERIORITY|Success for this endpoint was achieved if the probability of experiencing an event was statistically less than the performance goal, defined as 2.67%, with an upper bound of the one-sided 95% credible interval less than the performance goal.|probability of experiencing an event|2.2|||||ONE_SIDED|95.0||2.652||||||Bayesian calculations were used to incorporate the data from PROTECT AF CAP Registry through a conjugate beta-binomial model. A one-sided upper 95% credible interval for the event rate was calculated based off this posterior distribution.||2.652||
72506663|NCT03504774|144545318|OTHER||Mean Difference (Net)|0.6||||0.3|TWO_SIDED||||||Mixed Models Analysis|||analysis of the change from baseline in CD28 expression||||0.30
72506664|NCT03504774|144545319|OTHER||Mean Difference (Net)|0.9||||0.82|TWO_SIDED||||||Mixed Models Analysis|||within-group analysis of change from baseline to week 52||||0.82
72506665|NCT03504774|144545319|OTHER||Mean Difference (Net)|1.2||||0.053|TWO_SIDED||||||Mixed Models Analysis|||within-group analysis on the change from baseline to week 58||||0.053
72506666|NCT03504774|144545319|OTHER||Mean Difference (Net)|0.3||||0.062|TWO_SIDED||||||Mixed Models Analysis|||within-group analysis of change from week 52 to week 58||||0.062
72506667|NCT03504774|144545319|OTHER||Mean Difference (Net)|0.2||||0.3|TWO_SIDED||||||Mixed Models Analysis|||within-group analysis of change from baseline to week 52||||0.30
72472713|NCT01182441|144468666|NON_INFERIORITY|This endpoint is met if the 95% Credible Interval for the rate ratio of WATCHMAN versus Warfarin is entirely less than 1.75.|Risk Ratio (RR)|1.07|||||TWO_SIDED|95.0|0.57|1.89||||||A Bayesian piecewise exponential model was used to model the 18-month event rates. Historical priors for each interval model were based on PROTECT AF. Hazards were modeled for 0-7 day, 7-60 day, 60-182 day, and 182+ day intervals. Event rates were estimated separately by treatment group and event type. The posterior distribution for the 18-month event rate ratio (WATCHMAN vs. Warfarin), and the corresponding equitailed 95% credible interval, were determined via Monte Carlo simulations.||1.89|0.57|
72506668|NCT03504774|144545319|OTHER||Mean Difference (Net)|1.0||||0.54|TWO_SIDED||||||Mixed Models Analysis|||within-group analysis of change from baseline to week 58||||0.54
72623028|NCT02904096|144776389|NON_INFERIORITY|Estimates for PA, PB, and PA-PB were reported together with one-sided 95% confidence interval (CI) for PA-PB constructed via the Farrington-Manning likelihood method. Here PA and PB are the percentage of subjects in Group A and B (Non-inferiority margin = 12%).|Difference in percentage|1.5|||||ONE_SIDED|95.0||3.35||||||||3.35||
72506669|NCT03504774|144545319|OTHER||Mean Difference (Net)|1.2||||0.82|TWO_SIDED||||||Mixed Models Analysis|||within-group analysis of change from week 52 to week 58||||0.82
72506670|NCT03504774|144545320|OTHER||Mean Difference (Net)|4.8||||0.25|TWO_SIDED||||||Mixed Models Analysis|||within-group analysis of change in INFG from baseline to week 52||||0.25
72506671|NCT03504774|144545320|OTHER||Mean Difference (Net)|10.8||||0.24|TWO_SIDED||||||Mixed Models Analysis|||within-group analysis of change in INFG from baseline to week 58||||0.24
72506672|NCT03504774|144545320|OTHER||Mean Difference (Net)|6.0||||0.61|TWO_SIDED||||||Mixed Models Analysis|||within-group analysis of change in INFG from week 52 to week 58||||0.61
72506673|NCT03504774|144545320|OTHER||Mean Difference (Net)|8.5||||0.034|TWO_SIDED||||||Mixed Models Analysis|||within-group analysis of change in INFG from baseline to week 52||||0.034
72506674|NCT03504774|144545320|OTHER||Mean Difference (Net)|0.8||||0.45|TWO_SIDED||||||Mixed Models Analysis|||within-group analysis of change in INFG from baseline to week 58||||0.45
72506675|NCT03504774|144545320|OTHER||Mean Difference (Net)|7.7||||0.12|TWO_SIDED||||||Mixed Models Analysis|||within-group analysis of change in INFG from week 52 to week 58||||0.12
72506676|NCT03504774|144545320|OTHER||Mean Difference (Net)|1.0||||0.83|TWO_SIDED||||||Mixed Models Analysis|||within-group analysis of change in IL4 from baseline to week 52||||0.83
72506677|NCT03504774|144545320|OTHER||Mean Difference (Net)|2.0||||0.67|TWO_SIDED||||||Mixed Models Analysis|||within-group analysis of change in IL4 from baseline to week 58||||0.67
72506678|NCT03504774|144545320|OTHER||Mean Difference (Net)|1.0||||0.8|TWO_SIDED||||||Mixed Models Analysis|||within-group analysis of change in IL4 from week 52 to week 58||||0.80
72506679|NCT03504774|144545320|OTHER||Mean Difference (Net)|1.7||||0.46|TWO_SIDED||||||Mixed Models Analysis|||within-group analysis of change in IL4 from baseline to week 52||||0.46
72506680|NCT03504774|144545320|OTHER||Mean Difference (Net)|3.2||||0.48|TWO_SIDED||||||Mixed Models Analysis|||within-group analysis of change in IL4 from baseline to week 58||||0.48
72623029|NCT02904096|144776390|OTHER||Difference in Percentage|1.5|||||ONE_SIDED|95.0||3.35||||||||3.35||
72472714|NCT01182441|144468667|NON_INFERIORITY|This endpoint is met if either the 95% Credible Interval for the risk ratio \< 2.0 or the 95% Credible Interval for the risk difference is \< 0.0275.|Risk Difference (RD)|0.0053|||||TWO_SIDED|95.0|-0.019|0.0273||||||A Bayesian piecewise exponential model was used to model the 18-month event rates. Historical priors for each interval were based on PROTECT AF. Hazards were modeled for 0-7 day, 7-60 day, 60-182 day, and 182+ day intervals. Event rates were estimated separately for the WATCHMAN and Warfarin groups. The posterior distribution for the 18-month event rate ratio (WATCHMAN vs. Warfarin), and the corresponding equitailed 95% credible interval, were determined via Monte Carlo simulations.||0.0273|-0.0190|
72472715|NCT01182441|144468667|NON_INFERIORITY|This endpoint is met if either the 95% Credible Interval for the risk ratio \< 2.0 or the 95% Credible Interval for the risk difference is \< 0.0275.|Risk Ratio (RR)|1.6|||||TWO_SIDED|95.0|0.5|4.2||||||A Bayesian piecewise exponential model was used to model the 18-month event rates. Historical priors for each interval were based on PROTECT AF. Hazards were modeled for 0-7 day, 7-60 day, 60-182 day, and 182+ day intervals. Event rates were estimated separately for the WATCHMAN and Warfarin groups. The posterior distribution for the 18-month event rate ratio (WATCHMAN vs. Warfarin), and the corresponding equitailed 95% credible interval, were determined via Monte Carlo simulations.||4.2|0.5|
72472716|NCT02304705|144468717|SUPERIORITY|||||||0.052|||||||t-test, 2 sided|||||||.052
72472717|NCT05504954|144468735|SUPERIORITY||Odds Ratio (OR)|0.26||||0.15|TWO_SIDED|95.0|0.04|1.59|||Regression, Logistic|||||1.59|0.04|0.15
72472718|NCT05504954|144468737|SUPERIORITY||Odds Ratio (OR)|2.83||||0.1|TWO_SIDED|95.0|0.81|9.89|||Regression, Logistic|||||9.89|0.81|0.10
72472719|NCT05504954|144468738|SUPERIORITY||beta coefficient|5.0||||0.65|TWO_SIDED|95.0|-17.78|27.78|||Regression, Linear|||||27.78|-17.78|0.65
72472720|NCT05504954|144468739|SUPERIORITY|||||||0.7|||||||Fisher Exact|||||||0.70
72472721|NCT05504954|144468740|SUPERIORITY|||||||0.7|||||||Fisher Exact|||||||.70
72472722|NCT05504954|144468741|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.00
72472723|NCT05504954|144468742|SUPERIORITY|||||||0.64|||||||Fisher Exact|||||||0.64
72472724|NCT01757197|144468753|OTHER|Not evaluable.|Other|0.0|||||TWO_SIDED|||||Not evaluable.||||Not evaluable.|Not evaluable.|||
72472725|NCT01174446|144468766|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence will be established if 90% C.I. of ratio is contained completely in the margins of equivalence of 0.8 to 1.25.|Ratio of Geometric Means|1.063|||||TWO_SIDED|90.0|1.03|1.09||||||||1.09|1.03|
72472726|NCT01174446|144468793|SUPERIORITY_OR_OTHER_LEGACY|||||||0.779||95.0|||||Paired t-test|||||||0.7790
72472727|NCT01174446|144468793|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8999||95.0|||||Paired t-test|||||||0.8999
72472728|NCT01174446|144468794|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0056||95.0|||||Paired t-test|||||||0.0056
72472729|NCT01174446|144468794|SUPERIORITY_OR_OTHER_LEGACY|||||||0.413||95.0|||||Paired t-test|||||||0.4130
72472730|NCT01174446|144468795|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9059||95.0|||||Paired t-test|||||||0.9059
72472731|NCT01174446|144468795|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4098||95.0|||||Paired t-test|||||||0.4098
72506681|NCT03504774|144545320|OTHER||Mean Difference (Net)|3.2||||0.25|TWO_SIDED||||||Mixed Models Analysis|||within-group analysis of change in IL4 from week 52 to week 58||||0.25
72397879|NCT01287897|144301827|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.8|STANDARD_ERROR_OF_MEAN|11.1||0.2416|TWO_SIDED|90.0|-10.5|26.0|||GLMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in CDAI-70 response rate for the 200-mg arm at Week 6.||26.0|-10.5|0.2416
72472732|NCT01174446|144468796|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0189||95.0|||||Paired t-test|||||||0.0189
72472733|NCT01174446|144468796|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2974||95.0|||||Paired t-test|||||||0.2974
72472734|NCT01174446|144468797|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2009||95.0|||||Paired t-test|||||||0.2009
72472735|NCT01174446|144468797|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3552||95.0|||||Paired t-test|||||||0.3552
72472736|NCT01174446|144468798|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5143||95.0|||||Paired t-test|||||||0.5143
72472737|NCT01174446|144468798|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9223||95.0|||||Paired t-test|||||||0.9223
72472738|NCT01174446|144468799|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0162||95.0|||||Paired t-test|||||||0.0162
72472739|NCT01174446|144468799|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3176||95.0|||||Paired t-test|||||||0.3176
72472740|NCT01174446|144468800|SUPERIORITY_OR_OTHER_LEGACY|||||||0.821||95.0|||||Paired t-test|||||||0.8210
72472741|NCT01174446|144468800|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5565||95.0|||||Paired t-test|||||||0.5565
72472742|NCT01174446|144468801|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0146||95.0|||||Paired t-test|||||||0.0146
72506682|NCT03504774|144545320|OTHER||Mean Difference (Net)|2.6||||0.14|TWO_SIDED||||||Mixed Models Analysis|||within-group analysis of change in IL10 from baseline to week 52||||0.14
72506683|NCT03504774|144545320|OTHER||Mean Difference (Net)|0.6||||0.73|TWO_SIDED||||||Mixed Models Analysis|||within-group analysis of change in IL10 from baseline to week 58||||0.73
72472743|NCT01174446|144468801|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4048||95.0|||||Paired t-test|||||||0.4048
72472744|NCT01174446|144468802|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1258||95.0|||||Paired t-test|||||||0.1258
72472745|NCT01174446|144468802|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2567||95.0|||||Paired t-test|||||||0.2567
72472746|NCT01174446|144468803|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1048||95.0|||||Paired t-test|||||||0.1048
72472747|NCT01174446|144468803|SUPERIORITY_OR_OTHER_LEGACY|||||||0.641||95.0|||||Paired t-test|||||||0.6410
72472748|NCT01174446|144468804|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0663||95.0|||||Paired t-test|||||||0.0663
72472749|NCT01174446|144468804|SUPERIORITY_OR_OTHER_LEGACY|||||||0.489||95.0|||||Paired t-test|||||||0.4890
72472750|NCT01174446|144468805|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0562||95.0|||||Paired t-test|||||||0.0562
72472751|NCT01174446|144468805|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3864||95.0|||||Paired t-test|||||||0.3864
72472752|NCT01174446|144468806|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5792||95.0|||||Paired t-test|||||||0.5792
72472753|NCT01174446|144468807|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4208||95.0|||||Paired t-test|||||||0.4208
72506684|NCT03504774|144545320|OTHER||Mean Difference (Net)|2.0||||0.16|TWO_SIDED||||||Mixed Models Analysis|||within-group analysis of change in IL10 from week 52 to week 58||||0.16
72506685|NCT03504774|144545320|OTHER||Mean Difference (Net)|1.8||||0.47|TWO_SIDED||||||Mixed Models Analysis|||within-group analysis of change in IL10 from baseline to week 52||||0.47
72472754|NCT01174446|144468808|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5||95.0|||||Paired t-test|||||||0.5000
72472755|NCT01174446|144468809|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0633||95.0|||||Paired t-test|||||||0.0633
72472756|NCT01174446|144468809|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9363||95.0|||||Paired t-test|||||||0.9363
72472757|NCT00847626|144468823|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-13.0|||<|0.001|TWO_SIDED|95.0|-15.8|-9.5||Tested at 5% significance level.|ANCOVA|||Analysis of covariance model (ANCOVA) using treatment as a fixed effect and baseline as a covariate was performed. Results for Azilsartan Medoxomil 40 mg/Chlorthalidone 25 mg QD and Azilsartan Medoxomil 80 mg/Chlorthalidone 25 mg QD pool were obtained using contrast with coefficients of 0.5 for Azilsartan Medoxomil 40 mg/Chlorthalidone 25 mg QD and 0.5 for Azilsartan Medoxomil 80 mg/Chlorthalidone 25 mg QD from the ANCOVA model.||-9.5|-15.8|<0.001
72472758|NCT00847626|144468823|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.8|||<|0.001|TWO_SIDED|95.0|-16.7|-10.9||Tested at 5% significance level.|ANCOVA|||ANCOVA using treatment as a fixed effect and baseline as a covariate was performed. Results for Azilsartan Medoxomil 40 mg/Chlorthalidone 25 mg QD and Azilsartan Medoxomil 80 mg/Chlorthalidone 25 mg QD pool were obtained using contrast with coefficients of 0.5 for Azilsartan Medoxomil 40 mg/Chlorthalidone 25 mg QD and 0.5 for Azilsartan Medoxomil 80 mg/Chlorthalidone 25 mg QD from the ANCOVA model.||-10.9|-16.7|<0.001
72472759|NCT00847626|144468824|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.7|||<|0.001|TWO_SIDED|95.0|-16.2|-9.2||Tested at 5% significance level.|ANCOVA|||ANCOVA using treatment as a fixed effect and baseline as a covariate was performed.||-9.2|-16.2|<0.001
72472760|NCT00847626|144468824|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.9|||<|0.001|TWO_SIDED|95.0|-13.4|-6.4||Tested at 5% significance level.|ANCOVA|||ANCOVA using treatment as a fixed effect and baseline as a covariate was performed.||-6.4|-13.4|<0.001
72472761|NCT00847626|144468824|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.7|||<|0.001|TWO_SIDED|95.0|-19.2|-12.1||Tested at 5% significance level.|ANCOVA|||ANCOVA using treatment as a fixed effect and baseline as a covariate was performed.||-12.1|-19.2|<0.001
72472762|NCT00847626|144468824|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.4|||<|0.001|TWO_SIDED|95.0|-15.8|-8.9||Tested at 5% significance level.|ANCOVA|||ANCOVA using treatment as a fixed effect and baseline as a covariate was performed.||-8.9|-15.8|<0.001
72472763|NCT00847626|144468824|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.8|||<|0.001|TWO_SIDED|95.0|-19.3|-12.3||Tested at 5% significance level.|ANCOVA|||ANCOVA using treatment as a fixed effect and baseline as a covariate was performed.||-12.3|-19.3|<0.001
72472764|NCT00847626|144468824|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.0|||<|0.001|TWO_SIDED|95.0|-16.5|-9.5||Tested at 5% significance level.|ANCOVA|||ANCOVA using treatment as a fixed effect and baseline as a covariate was performed.||-9.5|-16.5|<0.001
72472765|NCT00847626|144468824|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.0|||<|0.001|TWO_SIDED|95.0|-17.5|-10.5||Tested at 5% significance level.|ANCOVA|||ANCOVA using treatment as a fixed effect and baseline as a covariate was performed.||-10.5|-17.5|<0.001
72472766|NCT00847626|144468824|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.2|||<|0.001|TWO_SIDED|95.0|-20.6|-13.7||Tested at 5% significance level.|ANCOVA|||ANCOVA using treatment as a fixed effect and baseline as a covariate was performed.||-13.7|-20.6|<0.001
72472767|NCT00847626|144468824|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.5|||<|0.001|TWO_SIDED|95.0|-17.0|-9.9||Tested at 5% significance level.|ANCOVA|||ANCOVA using treatment as a fixed effect and baseline as a covariate was performed.||-9.9|-17.0|<0.001
72506686|NCT03504774|144545320|OTHER||Mean Difference (Net)|1.1||||0.84|TWO_SIDED||||||Mixed Models Analysis|||within-group analysis of change in IL10 from baseline to week 58||||0.84
72506687|NCT03504774|144545320|OTHER||Mean Difference (Net)|0.7||||0.55|TWO_SIDED||||||Mixed Models Analysis|||within-group analysis of change in IL10 from week 52 to week 58||||0.55
72506688|NCT03504774|144545321|OTHER||Mean Difference (Net)|2269.0||||0.23|TWO_SIDED||||||Mixed Models Analysis|||within-group analysis of change in GPR15 from baseline to week 52||||0.23
72506689|NCT03504774|144545321|OTHER||Mean Difference (Net)|1311.0||||0.12|TWO_SIDED||||||Mixed Models Analysis|||within-group analysis of change in GPR15 from baseline to week 58||||0.12
72565807|NCT02709486|144662704|SUPERIORITY||Least Square Mean Difference|-0.96|STANDARD_ERROR_OF_MEAN|0.16|<|0.0001|TWO_SIDED|95.0|-1.28|-0.65|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.||-0.65|-1.28|<.0001
72623030|NCT02904096|144776391|OTHER||||||<|0.001|||||||t-test, 1 sided|||Comparison between Group A: Flexion (Left Hand)-baseline and Group A: Flexion (Left Hand)-change from baseline at Month 24.||||<.001
72506690|NCT03504774|144545321|OTHER||Mean Difference (Net)|958.0||||0.79|TWO_SIDED||||||Mixed Models Analysis|||within-group analysis of change in GPR15 from week 52 to week 58||||0.79
72506691|NCT03504774|144545321|OTHER||Mean Difference (Net)|347.0||||0.29|TWO_SIDED||||||Mixed Models Analysis|||within-group analysis of change in GPR15 from baseline to week 52||||0.29
72506692|NCT03504774|144545321|OTHER||Mean Difference (Net)|4364.0||||0.29|TWO_SIDED||||||Mixed Models Analysis|||within-group analysis of change in GPR15 from baseline to week 58||||0.29
72506693|NCT03504774|144545321|OTHER||Mean Difference (Net)|4017.0||||0.42|TWO_SIDED||||||Mixed Models Analysis|||within-group analysis of change in GPR15 from week 52 to week 58||||0.42
72506694|NCT02238028|144545345|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Paired t-test,2 sided|||Paired Student's t tests were used in the absence and presence of wearing respirators. HRV was log-transformed before regression analyses. Linear mixed-effect models were applied to investigate the effects of wearing respirators. Age, sex, body mass index, PM2.5 concentration, 48-h mean temperature and 48-h mean humidity were introduced into the model as fixed-effect terms. At last, we incorporated random-effect intercepts for subjects to account for correlations between repeated measurements.||||<0.05
72506695|NCT02238028|144545346|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Paired t-test,2 sided|||||||<0.05
72623031|NCT02904096|144776391|OTHER||||||<|0.001|||||||t-test, 1 sided|||Comparison between Group A: Flexion (Right Hand)-baseline and Group A: Flexion (Right Hand)-change from baseline at Month 24.||||<.001
72623032|NCT02904096|144776391|OTHER|||||||0.054|||||||t-test, 1 sided|||Comparison between Group B: Flexion (Left Hand)-baseline and Group B: Flexion (Left Hand)-change from baseline at Month 24.||||.054
72397880|NCT01287897|144301827|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|19.1|STANDARD_ERROR_OF_MEAN|14.1||0.088|TWO_SIDED|90.0|-4.1|42.3|||GLMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in CDAI-70 response rate for the 200-mg arm at Week 10.||42.3|-4.1|0.0880
72397881|NCT01287897|144301828|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.0|STANDARD_ERROR_OF_MEAN|3.2||0.261|TWO_SIDED|90.0|-3.2|7.2|||GLMM|Status of anti-TNF experience and concomitant immunosuppressant therapy were included as covariates.||LSM difference from placebo in CDAI remission rate for the 10-mg arm at Week 2.||7.2|-3.2|0.2610
72472768|NCT00847626|144468824|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.2|||<|0.001|TWO_SIDED|95.0|-19.7|-12.7||Tested at 5% significance level.|ANCOVA|||ANCOVA using treatment as a fixed effect and baseline as a covariate was performed.||-12.7|-19.7|<0.001
72472769|NCT00847626|144468824|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.8|||<|0.001|TWO_SIDED|95.0|-16.3|-9.3||Tested at 5% significance level.|ANCOVA|||ANCOVA using treatment as a fixed effect and baseline as a covariate was performed.||-9.3|-16.3|<0.001
72472770|NCT00847626|144468824|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.0|||<|0.001|TWO_SIDED|95.0|-19.4|-12.6||Tested at 5% significance level.|ANCOVA|||ANCOVA using treatment as a fixed effect and baseline as a covariate was performed.||-12.6|-19.4|<0.001
72472771|NCT00847626|144468825|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.8||||0.255|TWO_SIDED|95.0|-13.0|3.5||Tested at 5% significance level.|ANCOVA|||ANCOVA using treatment as a fixed effect and baseline as a covariate was performed. Results for Azilsartan Medoxomil 40 mg/Chlorthalidone 25 mg QD and Azilsartan Medoxomil 80mg/Chlorthalidone 25 mg QD pool were obtained using contrast with coefficients of 0.5 for Azilsartan Medoxomil 40 mg/Chlorthalidone 25 mg QD and 0.5 for Azilsartan Medoxomil 80 mg/Chlorthalidone 25 mg QD from the ANCOVA model.||3.5|-13.0|0.255
72472772|NCT00847626|144468825|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-18.2|||<|0.001|TWO_SIDED|95.0|-25.9|-10.6||Tested at 5% significance level.|ANCOVA|||ANCOVA using treatment as a fixed effect and baseline as a covariate was performed. Results for Azilsartan Medoxomil 40 mg/Chlorthalidone 25 mg QD and Azilsartan Medoxomil 80mg/Chlorthalidone 25 mg QD pool were obtained using contrast with coefficients of 0.5 for Azilsartan Medoxomil 40 mg/Chlorthalidone 25 mg QD and 0.5 for Azilsartan Medoxomil 80 mg/Chlorthalidone 25 mg QD from the ANCOVA model.||-10.6|-25.9|<0.001
72472773|NCT00847626|144468838|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.3|||<|0.001|TWO_SIDED|95.0|-13.6|-7.0||Tested at 5% significance level.|ANCOVA|||ANCOVA using treatment as a fixed effect and baseline as a covariate was performed.||-7.0|-13.6|< 0.001
72472774|NCT00847626|144468838|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.4|||<|0.001|TWO_SIDED|95.0|-13.7|-7.0||Tested at 5% significance level.|ANCOVA|||ANCOVA using treatment as a fixed effect and baseline as a covariate was performed.||-7.0|-13.7|<0.001
72472775|NCT00847626|144468838|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.8|||<|0.001|TWO_SIDED|95.0|-15.1|-8.4||Tested at 5% significance level.|ANCOVA|||ANCOVA using treatment as a fixed effect and baseline as a covariate was performed.||-8.4|-15.1|<0.001
72472776|NCT00847626|144468838|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.9|||<|0.001|TWO_SIDED|95.0|-17.3|-10.6||Tested at 5% significance level.|ANCOVA|||ANCOVA using treatment as a fixed effect and baseline as a covariate was performed.||-10.6|-17.3|<0.001
72472777|NCT00847626|144468838|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.7|||<|0.001|TWO_SIDED|95.0|-17.1|-10.3||Tested at 5% significance level.|ANCOVA|||ANCOVA using treatment as a fixed effect and baseline as a covariate was performed.||-10.3|-17.1|<0.001
72472778|NCT00847626|144468838|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.0|||<|0.001|TWO_SIDED|95.0|-15.4|-8.7||Tested at 5% significance level.|ANCOVA|||ANCOVA using treatment as a fixed effect and baseline as a covariate was performed.||-8.7|-15.4|<0.001
72472779|NCT00847626|144468838|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.9|||<|0.001|TWO_SIDED|95.0|-14.2|-7.6||Tested at 5% significance level.|ANCOVA|||ANCOVA using treatment as a fixed effect and baseline as a covariate was performed.||-7.6|-14.2|<0.001
72397882|NCT01287897|144301828|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.7|STANDARD_ERROR_OF_MEAN|3.8||0.4291|TWO_SIDED|90.0|-5.6|7.0|||GLMM|Status of anti-TNF experience and concomitant immunosuppressant therapy were included as covariates.||LSM difference from placebo in CDAI remission rate for the 10-mg arm at Week 4.||7.0|-5.6|0.4291
72506696|NCT00719576|144545353|SUPERIORITY|The Wilks lambda test statistic and associated single P value from the MANOVA model were used to test the statistical significance of the difference in the co-primary endpoint between MACI and microfracture.||||||0.001|||||||MANOVA|||The changes from Baseline to Week 104 in KOOS Pain and Function (SRA) scores (co-primary efficacy parameter) were analyzed with a multivariate analysis of variance (MANOVA) model, with the last observation carried forward (LOCF) method for handling missing data. Terms included in the model are treatment and center as class variables and baseline KOOS pain and Function (SRA) as continuous covariates.||||0.001
72506697|NCT00719576|144545354|SUPERIORITY_OR_OTHER_LEGACY|||||||0.717||||||Differences between groups were tested using analysis of variance|ANOVA|ANOVA with terms for treatment and center||||||.717
72506698|NCT00719576|144545355|SUPERIORITY|||||||0.92|||||||Cochran-Mantel-Haenszel|Cochran-Mantel Haenszel Row Mean Score Chi-Square||Differences between groups were tested by the Cochran-Mantel-Haenszel row mean score chi-squared test for defect fill.||||.920
72397883|NCT01287897|144301828|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.2|STANDARD_ERROR_OF_MEAN|6.0||0.5791|TWO_SIDED|90.0|-11.0|8.6|||GLMM|Status of anti-TNF experience and concomitant immunosuppressant therapy were included as covariates.||LSM difference from placebo in CDAI remission rate for the 10-mg arm at Week 6.||8.6|-11.0|0.5791
72397884|NCT01287897|144301828|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.5|STANDARD_ERROR_OF_MEAN|8.0||0.7544|TWO_SIDED|90.0|-18.8|7.7|||GLMM|Status of anti-TNF experience and concomitant immunosuppressant therapy were included as covariates.||LSM difference from placebo in CDAI remission rate for the 10-mg arm at Week 8.||7.7|-18.8|0.7544
72472780|NCT00847626|144468838|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.2|||<|0.001|TWO_SIDED|95.0|-17.6|-10.9||Tested at 5% significance level.|ANCOVA|||ANCOVA using treatment as a fixed effect and baseline as a covariate was performed.||-10.9|-17.6|<0.001
72472781|NCT00847626|144468838|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.6|||<|0.001|TWO_SIDED|95.0|-15.0|-8.3||Tested at 5% significance level.|ANCOVA|||ANCOVA using treatment as a fixed effect and baseline as a covariate was performed.||-8.3|-15.0|<0.001
72506699|NCT00719576|144545356|SUPERIORITY|||||||0.016||||||KOOS Response Rate: a participant is regarded as a responder for KOOS if a 10-point improvement in both KOOS Pain and Function (SRA) scores was achieved with respect to Baseline. Otherwise, the patient is regarded as a nonresponder.|Cochran-Mantel-Haenszel|p-value was calculated for response categories 'Responded' and 'Not responded' using a Cochran-Mantel-Haenszel χ2 Test stratified by Center||Differences between groups were tested by the Cochran-Mantel-Haenszel chi-squared test stratified by center for responders.||||0.016
72506700|NCT00719576|144545358|SUPERIORITY||||||<|0.001||||||KOOS activities of daily living p-value \<0.001|ANCOVA|||Analysis of covariance was conducted with treatment and center as fixed effects and Baseline subscale as covariate, conducted at α = 0.05 level of significance. Last observation carried forward was used for missing data imputation.||||<0.001
72506701|NCT00719576|144545358|SUPERIORITY|||||||0.029||||||KOOS knee-related quality of life p-value 0.029|ANCOVA|||Analysis of covariance was conducted with treatment and center as fixed effects and Baseline subscale as covariate, conducted at α = 0.05 level of significance. Last observation carried forward was used for missing data imputation.||||0.029
72506702|NCT00719576|144545358|SUPERIORITY||||||<|0.001||||||KOOS other symptoms p-value \<0.001|ANCOVA|||Analysis of covariance was conducted with treatment and center as fixed effects and Baseline subscale as covariate, conducted at α = 0.05 level of significance. Last observation carried forward was used for missing data imputation.||||<0.001
72506703|NCT00305006|144545360|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.0|STANDARD_DEVIATION|1.0|<|0.01|TWO_SIDED|95.0||||ANOVA|ANOVA|||ANOVA||||<0.01
72506704|NCT00631488|144545368|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.9||||0.002|TWO_SIDED|95.0|5.2|22.7|||Longitudinal Data Analysis|||Hypothesis: After 4 weeks of treatment, MK-0893+sitagliptin provide greater reduction in 24-hour WMG than sitagliptin+metformin. Using a standard deviation (SD) of 23.5 mg/dL, a sample size of 40 participants per group had 80% power to detect a true difference of 15 mg/dL in the mean change from BL in 24-hour WMG between any 2 treatment groups for a two-sided test at alpha=0.05, with a half-width of 10.3 mg/dL around the 95% confidence interval (CI) for the between group difference.||22.7|5.2|0.002
72506705|NCT00631488|144545368|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.8|||<|0.001|TWO_SIDED|95.0|-26.5|-9.2|||Longitudinal Data Analysis|||Hypothesis: After 4 weeks of treatment, MK-0893+metformin provide greater reduction in 24-hour WMG than sitagliptin+metformin. Using a standard deviation (SD) of 23.5 mg/dL, a sample size of 40 participants per group had 80% power to detect a true difference of 15 mg/dL in the mean change from BL in 24-hour WMG between any 2 treatment groups for a two-sided test at alpha=0.05, with a half-width of 10.3 mg/dL around the 95% confidence interval for the between group difference.||-9.2|-26.5|<0.001
72506706|NCT00631488|144545369|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.1||||0.05|TWO_SIDED|95.0|0.0|18.2|||Longitudinal Data Analysis|||Hypothesis: After 4 weeks of treatment, MK-0893+sitagliptin provide greater reduction in 24-hour FPG than sitagliptin+metformin. Using a standard deviation (SD) of 23.5 mg/dL, a sample size of 40 participants per group had 80% power to detect a true difference of 15 mg/dL in the mean change from BL in 24-hour FPG between any 2 treatment groups for a two-sided test at alpha=0.05, with a half-width of 10.3 mg/dL around the 95% confidence interval for the between group difference.||18.2|0.0|0.050
72506707|NCT00631488|144545369|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.1|||<|0.001|TWO_SIDED|95.0|-28.0|-10.1|||Longitudinal Data Analysis|||Hypothesis: After 4 weeks of treatment, MK-0893+metformin provide greater reduction in 24-hour FPG than sitagliptin+metformin. Using a standard deviation (SD) of 23.5 mg/dL, a sample size of 40 participants per group had 80% power to detect a true difference of 15 mg/dL in the mean change from BL in 24-hour FPG between any 2 treatment groups for a two-sided test at alpha=0.05, with a half-width of 10.3 mg/dL around the 95% confidence interval for the between group difference.||-10.1|-28.0|<0.001
72506708|NCT00631488|144545370|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|22.6||||0.056|TWO_SIDED|95.0|-0.6|45.8|||Longitudinal Data Analysis|||Hypothesis: After 4 weeks of treatment, MK-0893+sitagliptin provide greater reduction in 2-hr Glucose AUC than sitagliptin+metformin. Using a SD of 23.5 mg/dL, a sample size of 40 participants per group had 80% power to detect a true difference of 15 mg/dL in the mean change from BL in 2-Hour Glucose Total AUC between any 2 treatment groups for a two-sided test at alpha=0.05, with a half-width of 10.3 mg/dL around the 95% confidence interval for the between group difference.||45.8|-0.6|0.056
72506709|NCT00631488|144545370|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-44.6|||<|0.001|TWO_SIDED|95.0|-67.3|-21.8|||Longitudinal Data Analysis|||Hypothesis: After 4 weeks of treatment, MK-0893+metformin provide greater reduction in 2-hr Glucose AUC than sitagliptin+metformin. Using a SD of 23.5 mg/dL, a sample size of 40 participants per group had 80% power to detect a true difference of 15 mg/dL in the mean change from BL in 2-Hour Glucose Total AUC between any 2 treatment groups for a two-sided test at alpha=0.05, with a half-width of 10.3 mg/dL around the 95% confidence interval for the between group difference.||-21.8|-67.3|<0.001
72506710|NCT00631488|144545371|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.2||||0.001|TWO_SIDED|95.0|1.7|6.7|||Longitudinal Data Analysis|||Hypothesis: After 4 weeks of treatment, MK-0893+sitagliptin provide greater reduction in 2-Hour Total GLP-1 Total AUC than sitagliptin+metformin. Using a SD of 23.5 mg/dL, a sample size of 40 participants/group had 80% power to detect a true difference of 15 mg/dL in the mean change from BL in 2-Hour Total GLP-1 Total AUC between any 2 treatment groups for a 2-sided test at alpha=0.05, with a half-width of 10.3 mg/dL around the 95% CI for the between group difference.||6.7|1.7|0.001
72506711|NCT00631488|144545371|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.2|||<|0.001|TWO_SIDED|95.0|10.7|15.7|||Longitudinal Data Analysis|||Hypothesis: After 4 weeks of treatment, MK-0893+metformin provide greater reduction in 2-Hour Total GLP-1 Total AUC than sitagliptin+metformin. Using a SD of 23.5 mg/dL, a sample size of 40 participants/group had 80% power to detect a true difference of 15 mg/dL in the mean change from BL in 2-Hour Total GLP-1 Total AUC between any 2 treatment groups for a 2-sided test at alpha=0.05, with a half-width of 10.3 mg/dL around the 95% CI for the between group difference.||15.7|10.7|<0.001
72623033|NCT02904096|144776391|OTHER||||||<|0.001|||||||t-test, 1 sided|||Comparison between Group B: Flexion (Right Hand)-baseline and Group B: Flexion (Right Hand)-change from baseline at Month 24.||||<.001
72623034|NCT02904096|144776391|OTHER|||||||0.049|||||||t-test, 1 sided|||Comparison between Group A: Extension (Left Hand)-baseline and Group A: Extension (Left Hand)-change from baseline at Month 24.||||.049
72623035|NCT02904096|144776391|OTHER|||||||0.003|||||||t-test, 1 sided|||Comparison between Group A: Extension (Right Hand)-baseline and Group A: Extension (Right Hand)-change from baseline at Month 24.||||.003
72397885|NCT01287897|144301828|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.8|STANDARD_ERROR_OF_MEAN|9.2||0.2308||90.0|-8.3|21.9|||GLMM|Status of anti-TNF experience and concomitant immunosuppressant therapy were included as covariates.||LSM difference from placebo in CDAI remission rate for the 10-mg arm at Week 10.||21.9|-8.3|0.2308
72472782|NCT00847626|144468838|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.0|||<|0.001|TWO_SIDED|95.0|-20.4|-13.6||Tested at 5% significance level.|ANCOVA|||ANCOVA using treatment as a fixed effect and baseline as a covariate was performed.||-13.6|-20.4|<0.001
72472783|NCT00847626|144468838|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.2|||<|0.001|TWO_SIDED|95.0|-14.7|-7.8||Tested at 5% significance level.|ANCOVA|||ANCOVA using treatment as a fixed effect and baseline as a covariate was performed.||-7.8|-14.7|<0.001
72472784|NCT00847626|144468838|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.8|||<|0.001|TWO_SIDED|95.0|-16.2|-9.4||Tested at 5% significance level.|ANCOVA|||ANCOVA using treatment as a fixed effect and baseline as a covariate was performed.||-9.4|-16.2|<0.001
72472785|NCT00186017|144468897|SUPERIORITY_OR_OTHER|||||||0.08|||||||Wilcoxon (Mann-Whitney)|||||||.08
72472786|NCT00186017|144468898|SUPERIORITY_OR_OTHER||||||>|0.1|||||||Wilcoxon (Mann-Whitney)|||||||>.1
72472787|NCT00186017|144468899|SUPERIORITY_OR_OTHER||||||>|0.1|||||||Wilcoxon (Mann-Whitney)|||||||>.1
72472788|NCT00874731|144468901|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.48|||||TWO_SIDED|90.0|-2.8|3.76|||||Mean Difference in CFB = Ridaforolimus - Placebo||Mean difference and 90% confidence interval generated using a repeated measures mixed model that included treatment, time and treatment-by-time interaction as fixed factors and subject as random factor.|3.76|-2.80|
72472789|NCT00874731|144468904|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.54|||||TWO_SIDED|95.0|-3.83|2.74|||||Mean Difference in CFB = Ridaforolimus - Placebo||Mean difference and 90% confidence interval generated using a repeated measures mixed model that included treatment, time and treatment-by-time interaction as fixed factors and subject as random factor.|2.74|-3.83|
72472790|NCT00874731|144468905|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.18|||||TWO_SIDED|95.0|-4.5|2.14|||||Mean Difference in CFB = Ridaforolimus - Placebo||Mean difference and 90% confidence interval generated using a repeated measures mixed model that included treatment, time and treatment-by-time interaction as fixed factors and subject as random factor.|2.14|-4.50|
72472791|NCT00874731|144468906|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.47|||||TWO_SIDED|95.0|-2.85|3.79|||||Mean Difference in CFB = Ridaforolimus - Placebo||Mean difference and 90% confidence interval generated using a repeated measures mixed model that included treatment, time and treatment-by-time interaction as fixed factors and subject as random factor.|3.79|-2.85|
72472792|NCT00874731|144468907|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.18|||||TWO_SIDED|95.0|-2.1|4.47|||||Mean Difference in CFB = Ridaforolimus - Placebo||Mean difference and 90% confidence interval generated using a repeated measures mixed model that included treatment, time and treatment-by-time interaction as fixed factors and subject as random factor.|4.47|-2.10|
72472793|NCT00874731|144468908|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.49|||||TWO_SIDED|95.0|-0.79|5.78|||||Mean Difference in CFB = Ridaforolimus - Placebo||Mean difference and 90% confidence interval generated using a repeated measures mixed model that included treatment, time and treatment-by-time interaction as fixed factors and subject as random factor.|5.78|-0.79|
72472794|NCT00874731|144468909|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.48|||||TWO_SIDED|95.0|-0.8|5.76|||||Mean Difference in CFB = Ridaforolimus - Placebo||Mean difference and 90% confidence interval generated using a repeated measures mixed model that included treatment, time and treatment-by-time interaction as fixed factors and subject as random factor.|5.76|-0.80|
72472795|NCT00874731|144468910|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.89|||||TWO_SIDED|95.0|0.6|7.17|||||Mean Difference in CFB = Ridaforolimus - Placebo||Mean difference and 90% confidence interval generated using a repeated measures mixed model that included treatment, time and treatment-by-time interaction as fixed factors and subject as random factor.|7.17|0.60|
72472796|NCT00874731|144468911|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.5|||||TWO_SIDED|95.0|-4.85|1.86|||||Mean Difference in CFB = Ridaforolimus - Placebo||Mean difference and 90% confidence interval generated using a repeated measures mixed model that included treatment, time and treatment-by-time interaction as fixed factors and subject as random factor.|1.86|-4.85|
72472797|NCT02224703|144469013|SUPERIORITY||Treatment Ratio|0.743||||0.0299|TWO_SIDED|95.0|0.568|0.971|||Negative binomial regression|||Model includes total number of seizures as a response variable and age group, time (baseline and treatment period), treatment, and treatment by time interaction as fixed effects, and participant as a random effect. Log-transformed number of days in which seizures were reported by period is included as an offset. Null hypothesis was that the ratio of GWP42003-P to placebo would be 1.||0.971|0.568|0.0299
72472798|NCT02224703|144469013|SUPERIORITY||Treatment Ratio|0.702||||0.0095|TWO_SIDED|95.0|0.538|0.916|||Negative binomial regression|||Model includes total number of seizures as a response variable and age group, time (baseline and treatment period), treatment, and treatment by time interaction as fixed effects, and participant as a random effect. Log-transformed number of days in which seizures were reported by period is included as an offset. Null hypothesis was that the ratio of GWP42003-P to placebo would be 1.||0.916|0.538|0.0095
72472799|NCT02224703|144469014|SUPERIORITY||Treatment Ratio|0.749||||0.0255|TWO_SIDED|95.0|0.581|0.965|||Negative binomial regression|||Model includes total number of seizures as a response variable and age group, time (baseline and treatment period), treatment, and treatment by time interaction as fixed effects, and participant as a random effect. Log-transformed number of days in which seizures were reported by period is included as an offset.||0.965|0.581|0.0255
72472800|NCT02224703|144469014|SUPERIORITY||Treatment Ratio|0.62||||0.0003|TWO_SIDED|95.0|0.481|0.799|||Negative binomial regression|||Model includes total number of seizures as a response variable and age group, time (baseline and treatment period), treatment, and treatment by time interaction as fixed effects, and participant as a random effect. Log-transformed number of days in which seizures were reported by period is included as an offset.||0.799|0.481|0.0003
72472801|NCT02224703|144469015|SUPERIORITY||Odds Ratio (OR)|2.74||||0.0069|TWO_SIDED|95.0|1.32|5.7|||Cochran-Mantel-Haenszel|P-value calculated from a Cochran-Mantel-Haenszel test stratified by age group (2-5, 6-12, and 13-18 years).||||5.70|1.32|0.0069
72472802|NCT02224703|144469015|SUPERIORITY||Odds Ratio (OR)|2.21||||0.0332|TWO_SIDED|95.0|1.06|4.62|||Cochran-Mantel-Haenszel|P-value calculated from a Cochran-Mantel-Haenszel test stratified by age group (2-5, 6-12, and 13-18 years).||||4.62|1.06|0.0332
72397886|NCT01287897|144301828|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|7.1||0.5038|TWO_SIDED|90.0|-11.8|11.7|||GLMM|Status of anti-TNF experience and concomitant immunosuppressant therapy were included as covariates.||LSM difference from placebo in CDAI remission rate for the 10-mg arm at Week 12.||11.7|-11.8|0.5038
72397887|NCT01287897|144301828|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.0|STANDARD_ERROR_OF_MEAN|4.9||0.0498|TWO_SIDED|90.0|0.0|16.0|||GLMM|Status of anti-TNF experience and concomitant immunosuppressant therapy were included as covariates.||LSM difference from placebo in CDAI remission rate for the 50-mg arm at Week 2.||16.0|0.0|0.0498
72397888|NCT01287897|144301828|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.3|STANDARD_ERROR_OF_MEAN|7.6||0.0155|TWO_SIDED|90.0|3.9|28.7|||GLMM|Status of anti-TNF experience and concomitant immunosuppressant therapy were included as covariates.||LSM difference from placebo in CDAI remission rate for the 50-mg arm at Week 4.||28.7|3.9|0.0155
72397889|NCT01287897|144301828|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.9|STANDARD_ERROR_OF_MEAN|8.5||0.0399|TWO_SIDED|90.0|0.9|28.9|||GLMM|Status of anti-TNF experience and concomitant immunosuppressant therapy were included as covariates.||LSM difference from placebo in CDAI remission rate for the 50-mg arm at Week 6.||28.9|0.9|0.0399
72397890|NCT01287897|144301828|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.5|STANDARD_ERROR_OF_MEAN|9.6||0.1866|TWO_SIDED|90.0|-7.2|24.3|||GLMM|Status of anti-TNF experience and concomitant immunosuppressant therapy were included as covariates.||LSM difference from placebo in CDAI remission rate for the 50-mg arm at Week 8.||24.3|-7.2|0.1866
72397891|NCT01287897|144301828|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|17.8|STANDARD_ERROR_OF_MEAN|10.3||0.0415|TWO_SIDED|90.0|0.9|34.7|||GLMM|Status of anti-TNF experience and concomitant immunosuppressant therapy were included as covariates.||LSM difference from placebo in CDAI remission rate for the 50-mg arm at Week 10.||34.7|0.9|0.0415
72397892|NCT01287897|144301828|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.5|STANDARD_ERROR_OF_MEAN|9.5||0.0408|TWO_SIDED|90.0|0.9|32.1|||GLMM|Status of anti-TNF experience and concomitant immunosuppressant therapy were included as covariates.||LSM difference from placebo in CDAI remission rate for the 50-mg arm at Week 12.||32.1|0.9|0.0408
72472803|NCT02224703|144469016|SUPERIORITY||Odds Ratio (OR)|2.02||||0.0279|TWO_SIDED|95.0|1.08|3.78|||Regression, Logistic||Proportional odds modelling was carried out by including treatment group as a fixed factor. The estimated OR tested the null hypothesis that OR was equal to 1.|||3.78|1.08|0.0279
72397893|NCT01287897|144301829|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.8|STANDARD_ERROR_OF_MEAN|5.3||0.1342|TWO_SIDED|90.0|-2.8|14.5|||GLMM|Status of anti-TNF experience and concomitant immunosuppressant therapy were included as covariates.||LSM difference from placebo in CDAI remission rate for the 200-mg arm at Week 2.||14.5|-2.8|0.1342
72472804|NCT02224703|144469016|SUPERIORITY||Odds Ratio (OR)|2.93||||0.0009|TWO_SIDED|95.0|1.56|5.53|||Regression, Logistic||Proportional odds modelling was carried out by including treatment group as a fixed factor. The estimated OR tested the null hypothesis that OR was equal to 1.|||5.53|1.56|0.0009
72506712|NCT00631488|144545372|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.7|||<|0.001|TWO_SIDED|95.0|-9.5|-3.8|||Longitudinal Data Analysis|||Hypothesis: After 4 weeks of treatment, MK-0893+sitagliptin provide greater reduction in 2-Hour Active GLP-1 Total AUC than sitagliptin+metformin. Using a SD of 23.5 mg/dL, a sample size of 40 participants/group had 80% power to detect a true difference of 15 mg/dL in the mean change from BL in 2-Hour Active GLP-1 Total AUC between any 2 treatment groups for a 2-sided test at alpha=0.05, with a half-width of 10.3 mg/dL around the 95% CI for the between group difference||-3.8|-9.5|<0.001
72397894|NCT01287897|144301829|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.7|STANDARD_ERROR_OF_MEAN|4.3||0.2623|TWO_SIDED|90.0|-4.3|9.8|||GLMM|Status of anti-TNF experience and concomitant immunosuppressant therapy were included as covariates.||LSM difference from placebo in CDAI remission rate for the 200-mg arm at Week 4.||9.8|-4.3|0.2623
72397895|NCT01287897|144301829|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.7|STANDARD_ERROR_OF_MEAN|6.3||0.3324|TWO_SIDED|90.0|-7.7|13.2|||GLMM|Status of anti-TNF experience and concomitant immunosuppressant therapy were included as covariates.||LSM difference from placebo in CDAI remission rate for the 200-mg arm at Week 6.||13.2|-7.7|0.3324
72397896|NCT01287897|144301829|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.2|STANDARD_ERROR_OF_MEAN|7.5||0.6637|TWO_SIDED|90.0|-15.5|9.1|||GLMM|Status of anti-TNF experience and concomitant immunosuppressant therapy were included as covariates.||LSM difference from placebo in CDAI remission rate for the 200-mg arm at Week 8.||9.1|-15.5|0.6637
72397897|NCT01287897|144301829|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.4|STANDARD_ERROR_OF_MEAN|9.0||0.2721||90.0|-9.3|20.2|||GLMM|Status of anti-TNF experience and concomitant immunosuppressant therapy were included as covariates.||LSM difference from placebo in CDAI remission rate for the 200-mg arm at Week 10.||20.2|-9.3|0.2721
72397898|NCT01287897|144301829|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.0|STANDARD_ERROR_OF_MEAN|7.8||0.3022|TWO_SIDED|90.0|-8.8|16.9|||GLMM|Status of anti-TNF experience and concomitant immunosuppressant therapy were included as covariates.||LSM difference from placebo in CDAI remission rate for the 200-mg arm at Week 12.||16.9|-8.8|0.3022
72397899|NCT01287897|144301830|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.3|STANDARD_ERROR_OF_MEAN|7.0||0.2687|TWO_SIDED|90.0|-7.2|15.8|||GLMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in CDAI-100 response rate for the 10-mg arm at Week 2.||15.8|-7.2|0.2687
72397900|NCT01287897|144301830|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.1|STANDARD_ERROR_OF_MEAN|7.4||0.246|TWO_SIDED|90.0|-7.1|17.3|||GLMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in CDAI-100 response rate for the 10-mg arm at Week 4.||17.3|-7.1|0.2460
72397901|NCT01287897|144301830|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.2|STANDARD_ERROR_OF_MEAN|9.3||0.0633|TWO_SIDED|90.0|-1.1|29.5|||GLMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in CDAI-100 response rate for the 10-mg arm at Week 6.||29.5|-1.1|0.0633
72472805|NCT00659880|144469019|SUPERIORITY_OR_OTHER|||||||0.06|||||||Friedman|||||||0.06
72623036|NCT02904096|144776391|OTHER|||||||0.781|||||||t-test, 1 sided|||Comparison between Group B: Extension (Left Hand)-baseline and Group B: Extension (Left Hand)-change from baseline at Month 24.||||.781
72397902|NCT01287897|144301830|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.4|STANDARD_ERROR_OF_MEAN|9.9||0.4036|TWO_SIDED|90.0|-13.8|18.6|||GLMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in CDAI-100 response rate for the 10-mg arm at Week 8.||18.6|-13.8|0.4036
72506713|NCT00631488|144545372|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.3|||<|0.001|TWO_SIDED|95.0|-14.1|-8.5|||Longitudinal Data Analysis|||Hypothesis: After 4 weeks of treatment, MK-0893+metformin provide greater reduction in 2-Hour Active GLP-1 Total AUC than sitagliptin+metformin. Using a SD of 23.5 mg/dL, a sample size of 40 participants/group had 80% power to detect a true difference of 15 mg/dL in the mean change from BL in 2-Hour Active GLP-1 Total AUC between any 2 treatment groups for a 2-sided test at alpha=0.05, with a half-width of 10.3 mg/dL around the 95% CI for the between group difference.||-8.5|-14.1|<0.001
72506714|NCT00103194|144545373|SUPERIORITY_OR_OTHER||PSA response rate|0.0|||||TWO_SIDED|90.0|0.0|8.2||||||||8.2|0|
72506715|NCT00103194|144545374|SUPERIORITY_OR_OTHER|||||||0.006||95.0|||||Mixed Models Analysis|The analysis is testing the null hypothesis that there is no difference between the pre-treatment and post-treatment PSA slopes.||||||0.006
72506716|NCT01671085|144545410|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-50.49|||<|0.001|TWO_SIDED|90.0|-71.27|-29.7||P-value is for Day 43.|Mixed Effects Model Analysis|||||-29.70|-71.27|<0.001
72506717|NCT01671085|144545410|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-45.11|||<|0.001|TWO_SIDED|90.0|-65.91|-24.31||P-value is for Day 57.|Mixed Effects Models Analysis|||||-24.31|-65.91|<0.001
72506718|NCT00637273|144545411|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.63|STANDARD_ERROR_OF_MEAN|0.131|<|0.0001|TWO_SIDED|95.0|0.37|0.89||Adjusted p-value was derived using Hochberg's procedure for multiple treatment comparisons.|ANOVA|Analysis of Variance (ANOVA) model includes treatment, country, and baseline HbA1c stratum (\<9.0% or \>=9.0%) as factors.||Null hypothesis: no difference across treatments. Alternative hypothesis: a difference exists between exenatide once weekly and at least one comparator group (sitagliptin or pioglitazone). Power: Assuming 10% dropout, delta=0.5%, and common SD=1.2%, 450 subjects would provide \>90% power to detect a treatment difference (alpha=0.05, two-sided) in the change in HbA1c between exenatide once weekly and sitagliptin or pioglitazone, with Hochberg's multiplicity adjustment method.||0.89|0.37|<.0001
72506719|NCT00637273|144545411|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.32|STANDARD_ERROR_OF_MEAN|0.131||0.0165|TWO_SIDED|95.0|0.06|0.57||Adjusted p-value was derived using Hochberg's procedure for multiple treatment comparisons.|ANOVA|Analysis of Variance (ANOVA) model includes treatment, country, and baseline HbA1c stratum (\<9.0% or \>=9.0%) as factors.||Null hypothesis: no difference across treatments. Alternative hypothesis: a difference exists between exenatide once weekly and at least one comparator group (sitagliptin or pioglitazone). Power: Assuming 10% dropout, delta=0.5%, and common SD=1.2%, 450 subjects would provide \>90% power to detect a treatment difference (alpha=0.05, two-sided) in the change in HbA1c between exenatide once weekly and sitagliptin or pioglitazone, with Hochberg's multiplicity adjustment method.||0.57|0.06|0.0165
72506720|NCT00637273|144545412|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Adjusted p-value was derived using Hochberg's procedure for multiple treatment comparisons.|Cochran-Mantel-Haenszel|||Analysis: Percentage of subjects achieving HbA1c target of \<7% at Week 26 were compared between treatments using a Cochran Mantel Haenszel (CMH) test, in which baseline HbA1c stratum (\<9% or \>=9%) and country served as stratification factors. Null hypothesis: no difference across treatments. Power: based on the primary measurement.||||<.0001
72506721|NCT00637273|144545412|SUPERIORITY_OR_OTHER|||||||0.0015|TWO_SIDED|||||Adjusted p-value was derived using Hochberg's procedure for multiple treatment comparisons.|Cochran-Mantel-Haenszel|||Analysis: Percentage of subjects achieving HbA1c target of \<7% at Week 26 were compared between treatments using a Cochran Mantel Haenszel (CMH) test, in which baseline HbA1c stratum (\<9% or \>=9%) and country served as stratification factors. Null hypothesis: no difference across treatments. Power: based on the primary measurement.||||0.0015
72506722|NCT00637273|144545413|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Adjusted p-value was derived using Hochberg's procedure for multiple treatment comparisons.|Cochran-Mantel-Haenszel|||Analysis: Percentages of subjects achieving HbA1c target of \<=6.5% at Week 26 were compared between treatments using a CMH test, in which baseline HbA1c stratum (\<9% or \>=9%) and country served as stratification factors. Null hypothesis: no difference across treatments. Power: based on the primary measurement.||||<.0001
72506723|NCT00637273|144545413|SUPERIORITY_OR_OTHER|||||||0.012|TWO_SIDED|||||Adjusted p-value was derived using Hochberg's procedure for multiple treatment comparisons.|Cochran-Mantel-Haenszel|||Analysis: Percentages of subjects achieving HbA1c target of \<=6.5% at Week 26 were compared between treatments using a CMH test, in which baseline HbA1c stratum (\<9% or \>=9%) and country served as stratification factors. Null hypothesis: no difference across treatments. Power: based on the primary measurement.||||0.0120
72506724|NCT00637273|144545414|SUPERIORITY_OR_OTHER|||||||0.17|TWO_SIDED|||||Adjusted p-value was derived using Hochberg's procedure for multiple treatment comparisons.|Cochran-Mantel-Haenszel|||Analysis: Percentages of subjects achieving HbA1c target of \<=6.0% at Week 26 were compared between treatments using a CMH test, in which baseline HbA1c stratum (\<9% or \>=9%) and country served as stratification factors. Null hypothesis: no difference across treatments. Power: based on the primary measurement.||||0.1700
72506725|NCT00637273|144545414|SUPERIORITY_OR_OTHER|||||||0.0091|TWO_SIDED|||||Adjusted p-value was derived using Hochberg's procedure for multiple treatment comparisons.|Cochran-Mantel-Haenszel|||Analysis: Percentages of subjects achieving HbA1c target of \<=6.0% at Week 26 were compared between treatments using a CMH test, in which baseline HbA1c stratum (\<9% or \>=9%) and country served as stratification factors. Null hypothesis: no difference across treatments. Power: based on the primary measurement.||||0.0091
72506726|NCT00637273|144545415|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|1.54|STANDARD_ERROR_OF_MEAN|0.416||0.0002|TWO_SIDED|95.0|0.72|2.35||Adjusted p-value was derived using Hochberg's procedure for multiple treatment comparisons.|ANCOVA|||Analysis: Change in body weight from baseline (Day 1) to Week 26 was analyzed by an analysis of covariance (ANCOVA) model including treatment, country, and baseline HbA1c stratum (\<9.0% or \>=9.0%) as factors, and baseline value of body weight as a covariate. Null hypothesis: no difference across treatments. Power: based on the primary measurement.||2.35|0.72|0.0002
72623037|NCT02904096|144776391|OTHER|||||||0.573|||||||t-test, 1 sided|||Comparison between Group B: Extension (Right Hand)-baseline and Group B: Extension (Right Hand)-change from baseline at Month 24.||||.573
72397903|NCT01287897|144301830|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.9|STANDARD_ERROR_OF_MEAN|10.2||0.1921||90.0|-7.9|25.6|||GLMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in CDAI-100 response rate for the 10-mg arm at Week 10.||25.6|-7.9|0.1921
72397904|NCT01287897|144301830|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.5|STANDARD_ERROR_OF_MEAN|10.3||0.1541|TWO_SIDED|90.0|-6.5|27.5|||GLMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in CDAI-100 response rate for the 10-mg arm at Week 12.||27.5|-6.5|0.1541
72397905|NCT01287897|144301830|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|6.5||0.4893|TWO_SIDED|90.0|-10.5|10.9|||GLMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in CDAI-100 response rate for the 50-mg arm at Week 2.||10.9|-10.5|0.4893
72472806|NCT01621776|144469089|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|145.1|STANDARD_DEVIATION|78.04||0.971||95.0|129.73|160.47|||ANOVA||This is a three arm study that is not seeking to engage in comparison between individual arms, therefore the mean difference across the study arms is reported.|||160.47|129.73|.971
72472807|NCT01621776|144469090|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|161.09|STANDARD_DEVIATION|62.67||0.698|TWO_SIDED|95.0|144.91|177.28|||ANOVA||This is a three arm study that is not seeking to engage in comparison between individual arms, therefore the mean difference across the study arms is reported.|||177.28|144.91|.698
72472808|NCT01621776|144469091|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|220.46|STANDARD_DEVIATION|89.97||0.806|TWO_SIDED|95.0|197.22|243.71|||ANOVA||This is a three arm study that is not seeking to engage in comparison between individual arms, therefore the mean difference across the study arms is reported.|||243.71|197.22|.806
72472809|NCT02269423|144469100|OTHER||||||<|0.001||||||p-values are pairwise comparisons of log-transformed titers between each V920 dose, between each V920 dose and placebo, between all V920 dose levels combined and placebo and are from an ANOVA model.|ANOVA|Adjustments for multiple comparisons were not performed.||Day 28||||<0.001
72472810|NCT02269423|144469100|OTHER||||||<|0.001||||||p-values are pairwise comparisons of log-transformed titers between each V920 dose, between each V920 dose and placebo, between all V920 dose levels combined and placebo and are from an ANOVA model.|ANOVA|Adjustments for multiple comparisons were not performed.||Day 28||||<0.001
72506727|NCT00637273|144545415|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|5.1|STANDARD_ERROR_OF_MEAN|0.415|<|0.0001|TWO_SIDED|95.0|4.28|5.91||Adjusted p-value was derived using Hochberg's procedure for multiple treatment comparisons.|ANCOVA|||Analysis: Change in body weight from baseline (Day 1) to Week 26 was analyzed by an analysis of covariance (ANCOVA) model including treatment, country, and baseline HbA1c stratum (\<9.0% or \>=9.0%) as factors, and baseline value of body weight as a covariate. Null hypothesis: no difference across treatments. Power: based on the primary measurement.||5.91|4.28|<.0001
72623038|NCT02904096|144776392|OTHER||||||<|0.001|||||||t-test, 1 sided|||Comparison between Group A: (Left Hand)-baseline and Group A: (Left Hand)-change from baseline at Month 24.||||<.001
72472811|NCT02269423|144469100|OTHER||||||<|0.001||||||p-values are pairwise comparisons of log-transformed titers between each V920 dose, between each V920 dose and placebo, between all V920 dose levels combined and placebo and are from an ANOVA model.|ANOVA|Adjustments for multiple comparisons were not performed.||Day 28||||<0.001
72472812|NCT02269423|144469100|OTHER|||||||0.161||||||p-values are pairwise comparisons of log-transformed titers between each V920 dose, between each V920 dose and placebo, between all V920 dose levels combined and placebo and are from an ANOVA model.|ANOVA|Adjustments for multiple comparisons were not performed.||Day 28||||0.161
72472813|NCT02269423|144469100|OTHER|||||||0.008||||||p-values are pairwise comparisons of log-transformed titers between each V920 dose, between each V920 dose and placebo, between all V920 dose levels combined and placebo and are from an ANOVA model.|ANOVA|Adjustments for multiple comparisons were not performed.||Day 28||||0.008
72472814|NCT02269423|144469100|OTHER|||||||0.173||||||p-values are pairwise comparisons of log-transformed titers between each V920 dose, between each V920 dose and placebo, between all V920 dose levels combined and placebo and are from an ANOVA model.|ANOVA|Adjustments for multiple comparisons were not performed.||Day 28||||0.173
72472815|NCT02269423|144469101|OTHER||||||<|0.001||||||p-values are pairwise comparisons of log-transformed titers between each V920 dose, between each V920 dose and placebo, between all V920 dose levels combined and placebo and are from an ANOVA model.|ANOVA|Adjustments for multiple comparisons were not performed.||Day 28||||<0.001
72472816|NCT02269423|144469101|OTHER||||||<|0.001||||||p-values are pairwise comparisons of log-transformed titers between each V920 dose, between each V920 dose and placebo, between all V920 dose levels combined and placebo and are from an ANOVA model.|ANOVA|Adjustments for multiple comparisons were not performed.||Day 28||||<0.001
72472817|NCT02269423|144469101|OTHER||||||<|0.001||||||p-values are pairwise comparisons of log-transformed titers between each V920 dose, between each V920 dose and placebo, between all V920 dose levels combined and placebo and are from an ANOVA model.|ANOVA|Adjustments for multiple comparisons were not performed.||Day 28||||<0.001
72472818|NCT02269423|144469101|OTHER|||||||0.102||||||p-values are pairwise comparisons of log-transformed titers between each V920 dose, between each V920 dose and placebo, between all V920 dose levels combined and placebo and are from an ANOVA model.|ANOVA|Adjustments for multiple comparisons were not performed.||Day 28||||0.102
72472819|NCT02269423|144469101|OTHER|||||||0.124||||||p-values are pairwise comparisons of log-transformed titers between each V920 dose, between each V920 dose and placebo, between all V920 dose levels combined and placebo and are from an ANOVA model.|ANOVA|Adjustments for multiple comparisons were not performed.||Day 28||||0.124
72472820|NCT02269423|144469101|OTHER|||||||0.918||||||p-values are pairwise comparisons of log-transformed titers between each V920 dose, between each V920 dose and placebo, between all V920 dose levels combined and placebo and are from an ANOVA model.|ANOVA|Adjustments for multiple comparisons were not performed.||Day 28||||0.918
72472821|NCT00203268|144469114|SUPERIORITY_OR_OTHER|||||||0.3025|||||||clustered survival analysis|||||||.3025
72397906|NCT01287897|144301830|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.2|STANDARD_ERROR_OF_MEAN|8.6||0.0619|TWO_SIDED|90.0|-0.9|27.4|||GLMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in CDAI-100 response rate for the 50-mg arm at Week 4.||27.4|-0.9|0.0619
72506728|NCT00637273|144545416|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|15.5|STANDARD_ERROR_OF_MEAN|4.95||0.0038|TWO_SIDED|95.0|5.7|25.2||Adjusted p-value was derived using Hochberg's procedure for multiple treatment comparisons.|ANCOVA|||Analysis: Change in fasting plasma glucose from baseline (Day 1) to Week 26 was analyzed using an ANCOVA model including treatment, country, and baseline HbA1c stratum (\<9.0% or \>=9.0%) as factors, and baseline value of fasting plasma glucose as a covariate. Null hypothesis: no difference across treatments. Power: based on the primary measurement.||25.2|5.7|0.0038
72506729|NCT00637273|144545416|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|4.4|STANDARD_ERROR_OF_MEAN|4.98||0.3729|TWO_SIDED|95.0|-5.3|14.2||Adjusted p-value was derived using Hochberg's procedure for multiple treatment comparisons.|ANCOVA|||Analysis: Change in fasting plasma glucose from baseline (Day 1) to Week 26 was analyzed using an ANCOVA model including treatment, country, and baseline HbA1c stratum (\<9.0% or \>=9.0%) as factors, and baseline value of fasting plasma glucose as a covariate. Null hypothesis: no difference across treatments. Power: based on the primary measurement.||14.2|-5.3|0.3729
72506730|NCT00637273|144545417|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|3.8|STANDARD_ERROR_OF_MEAN|1.26||0.0055|TWO_SIDED|95.0|1.3|6.3||Adjusted p-value was derived using Hochberg's procedure for multiple treatment comparisons.|ANCOVA|||Analysis: Change in systolic blood pressure from baseline (Day 1) to Week 26 was analyzed by an ANCOVA model including treatment, country, and baseline HbA1c stratum (\<9.0% or \>=9.0%) as factors, and baseline value of systolic blood pressure as a covariate. Null hypothesis: no difference across treatments. Power: based on the primary measurement.||6.3|1.3|0.0055
72506731|NCT00637273|144545417|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|2.0|STANDARD_ERROR_OF_MEAN|1.25||0.1117|TWO_SIDED|95.0|-0.5|4.5||Adjusted p-value was derived using Hochberg's procedure for multiple treatment comparisons.|ANCOVA|||Analysis: Change in systolic blood pressure from baseline (Day 1) to Week 26 was analyzed by an ANCOVA model including treatment, country, and baseline HbA1c stratum (\<9.0% or \>=9.0%) as factors, and baseline value of systolic blood pressure as a covariate. Null hypothesis: no difference across treatments. Power: based on the primary measurement.||4.5|-0.5|0.1117
72506732|NCT00637273|144545418|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|1.0|STANDARD_ERROR_OF_MEAN|0.75||0.1685|TWO_SIDED|95.0|-0.4|2.5||Adjusted p-value was derived using Hochberg's procedure for multiple treatment comparisons.|ANCOVA|||Analysis: Change in diastolic blood pressure from baseline (Day 1) to Week 26 was analyzed by an ANCOVA model including treatment, country, and baseline HbA1c stratum (\<9.0% or \>=9.0%) as factors, and baseline value of diastolic blood pressure as a covariate. Null hypothesis: no difference across treatments. Power: based on the primary measurement.||2.5|-0.4|0.1685
72565808|NCT02709486|144662704|SUPERIORITY||Least Square Mean Difference|-0.76|STANDARD_ERROR_OF_MEAN|0.18|<|0.0001|TWO_SIDED|95.0|-1.11|-0.42|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.||-0.42|-1.11|<.0001
72623039|NCT02904096|144776392|OTHER||||||<|0.001|||||||t-test, 1 sided|||Comparison between Group A: (Right Hand)-baseline and Group A: (Right Hand)-change from baseline at Month 24.||||<.001
72623040|NCT02904096|144776392|OTHER||||||<|0.001|||||||t-test, 1 sided|||Comparison between Group B: (Left Hand)-baseline and Group B: (Left Hand)-change from baseline at Month 24.||||<.001
72397907|NCT01287897|144301830|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|17.7|STANDARD_ERROR_OF_MEAN|9.3||0.029|TWO_SIDED|90.0|2.3|33.1|||GLMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in CDAI-100 response rate for the 50-mg arm at Week 6.||33.1|2.3|0.0290
72397908|NCT01287897|144301830|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.8|STANDARD_ERROR_OF_MEAN|10.7||0.0988|TWO_SIDED|90.0|-3.8|31.4|||GLMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in CDAI-100 response rate for the 50-mg arm at Week 8.||31.4|-3.8|0.0988
72472822|NCT02514551|144469118|SUPERIORITY||Hazard Ratio (HR)|0.617|||||TWO_SIDED|95.0|0.447|0.853|||||Unstratified cox proportional hazards model comparing Ramucirumab I4T-MC-JVCZ and I4T-IE-JVBE (NCT01170663)|"This analysis were comparison of PFS for participants treated with ramucirumab 12 mg/kg plus paclitaxel in Study I4T-MC-JVCZ versus placebo plus paclitaxel in I4T-IE-JVBE (NCT01170663) using meta-analysis.~Placebo + 80 mg/m² Paclitaxel in I4T-IE-JVBE Number of participants: 335, Median (95% CI), months: 2.86 (2.79 to 3.02)"||0.853|0.447|
72472823|NCT02514551|144469119|SUPERIORITY||Hazard Ratio (HR)|0.963|||||TWO_SIDED|95.0|0.727|1.274|||||Unstratified cox proportional hazards model.|||1.274|0.727|
72472824|NCT05472740|144469144|SUPERIORITY|||||||0.039|||||||Wilcoxon (Mann-Whitney)|||||||0.039
72472825|NCT04944290|144469155|EQUIVALENCE|8AM Day 14|Mean Difference (Net)|-0.14|||||TWO_SIDED|95.0|-0.71|0.51||||||||0.51|-0.71|
72472826|NCT04944290|144469155|EQUIVALENCE|10AM Day 14|Mean Difference (Net)|-0.35|||||TWO_SIDED|95.0|-0.86|0.26||||||10AM Day 14||0.26|-0.86|
72472827|NCT04944290|144469155|EQUIVALENCE|8AM Day 42|Mean Difference (Net)|-0.04|||||TWO_SIDED|95.0|-0.58|0.58||||||||0.58|-0.58|
72472828|NCT04944290|144469155|EQUIVALENCE|10AM Day 42|Mean Difference (Net)|-0.16|||||TWO_SIDED|95.0|-0.7|0.47||||||||0.47|-0.70|
72472829|NCT03838731|144469156|SUPERIORITY||Hazard Ratio (HR)|0.36|||=|0.0083|TWO_SIDED|95.0|0.17|0.77|||Cox Proportional Hazard|||||0.77|0.17|= 0.0083
72472830|NCT03838731|144469157|SUPERIORITY||Hazard Ratio (HR)|0.24|||<|0.0001|TWO_SIDED|95.0|0.12|0.48|||Cox Hazard Model|||Day 29||0.48|0.12|< 0.0001
72472831|NCT03838731|144469157|SUPERIORITY||Hazard Ratio (HR)|0.45|||=|0.0222||95.0|0.22|0.89|||Cox Hazard Model|||Day 57||0.89|0.22|= 0.0222
72472832|NCT03838731|144469157|SUPERIORITY||Hazard Ratio (HR)|0.27|||=|0.0003||95.0|0.13|0.56|||Cox Hazard Model|||Day 85||0.56|0.13|= 0.0003
72472833|NCT03838731|144469158|SUPERIORITY|Day 8|LS Mean Difference|13.56|STANDARD_ERROR_OF_MEAN|3.59|<|0.001|TWO_SIDED|95.0|6.35|20.77|||MMRM|||||20.77|6.35|<0.001
72472834|NCT03838731|144469158|SUPERIORITY|Day 29|LS Mean Difference|16.21|STANDARD_ERROR_OF_MEAN|4.97|=|0.002|TWO_SIDED|95.0|6.18|26.24|||MMRM|||||26.24|6.18|= 0.002
72472835|NCT03838731|144469158|SUPERIORITY|Day 57|LS Mean Difference|12.3|STANDARD_ERROR_OF_MEAN|4.94|=|0.016|TWO_SIDED|95.0|2.4|22.2|||MMRM|||||22.20|2.40|= 0.016
72472836|NCT03838731|144469158|SUPERIORITY|Day 85|LS Mean Difference|12.54|STANDARD_ERROR_OF_MEAN|4.54|=|0.008|TWO_SIDED|95.0|3.43|21.65|||MMRM|||||21.65|3.43|= 0.008
72506733|NCT00637273|144545418|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|0.75||0.1685|TWO_SIDED|95.0|-2.6|0.4||Adjusted p-value was derived using Hochberg's procedure for multiple treatment comparisons.|ANCOVA|||Analysis: Change in diastolic blood pressure from baseline (Day 1) to Week 26 was analyzed by an ANCOVA model including treatment, country, and baseline HbA1c stratum (\<9.0% or \>=9.0%) as factors, and baseline value of diastolic blood pressure as a covariate. Null hypothesis: no difference across treatments. Power: based on the primary measurement.||0.4|-2.6|0.1685
72397909|NCT01287897|144301830|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|17.2|STANDARD_ERROR_OF_MEAN|10.8||0.0549|TWO_SIDED|90.0|-0.5|35.0|||GLMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in CDAI-100 response rate for the 50-mg arm at Week 10.||35.0|-0.5|0.0549
72506734|NCT00637273|144545419|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|3.7|STANDARD_ERROR_OF_MEAN|3.31||0.2686|TWO_SIDED|95.0|-2.8|10.2||Adjusted p-value was derived using Hochberg's procedure for multiple treatment comparisons.|ANCOVA|||Analysis: Change in fasting total cholesterol from baseline (Day 1) to Week 26 was analyzed by an ANCOVA model including treatment, country, and baseline HbA1c stratum (\<9.0% or \>=9.0%) as factors, and baseline value of fasting total cholesterol as a covariate. Null hypothesis: no difference across treatments. Power: based on the primary measurement.||10.2|-2.8|0.2686
72506735|NCT00637273|144545419|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|6.8|STANDARD_ERROR_OF_MEAN|3.3||0.0814|TWO_SIDED|95.0|0.3|13.2||Adjusted p-value was derived using Hochberg's procedure for multiple treatment comparisons.|ANCOVA|||Analysis: Change in fasting total cholesterol from baseline (Day 1) to Week 26 was analyzed by an ANCOVA model including treatment, country, and baseline HbA1c stratum (\<9.0% or \>=9.0%) as factors, and baseline value of fasting total cholesterol as a covariate. Null hypothesis: no difference across treatments. Power: based on the primary measurement.||13.2|0.3|0.0814
72506736|NCT00637273|144545420|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.8||0.9546|TWO_SIDED|95.0|-1.6|1.5||Adjusted p-value was derived using Hochberg's procedure for multiple treatment comparisons.|ANCOVA|||Analysis: Change in fasting HDL from baseline (Day 1) to Week 26 was analyzed by an ANCOVA model including treatment, country, and baseline HbA1c stratum (\<9.0% or \>=9.0%) as factors, and baseline value of fasting HDL as a covariate. Null hypothesis: no difference across treatments. Power: based on the primary measurement.||1.5|-1.6|0.9546
72506737|NCT00637273|144545420|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|4.2|STANDARD_ERROR_OF_MEAN|0.79|<|0.0001|TWO_SIDED|95.0|2.6|5.7||Adjusted p-value was derived using Hochberg's procedure for multiple treatment comparisons.|ANCOVA|||Analysis: Change in fasting HDL from baseline (Day 1) to Week 26 was analyzed by an ANCOVA model including treatment, country, and baseline HbA1c stratum (\<9.0% or \>=9.0%) as factors, and baseline value of fasting HDL as a covariate. Null hypothesis: no difference across treatments. Power: based on the primary measurement.||5.7|2.6|<.0001
72506738|NCT00637273|144545421|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean Ratio|1.0|STANDARD_ERROR_OF_MEAN|0.04||0.9718|TWO_SIDED|95.0|0.93|1.08||Adjusted p-value was derived using Hochberg's procedure for multiple treatment comparisons.|ANCOVA|||Analysis: Triglycerides data were logarithm-transformed and the change at Week 26 to baseline (Day 1), expressed as the ratio, was analyzed by an ANCOVA model including treatment, country, and baseline HbA1c stratum (\<9.0% or \>=9.0%) as factors, and baseline value of fasting triglycerides as a covariate. Null hypothesis: no difference across treatments. Power: based on the primary measurement.||1.08|0.93|0.9718
72506739|NCT00637273|144545421|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean Ratio|0.89|STANDARD_ERROR_OF_MEAN|0.035||0.0062|TWO_SIDED|95.0|0.82|0.96||Adjusted p-value was derived using Hochberg's procedure for multiple treatment comparisons.|ANCOVA|||Analysis: Triglycerides data were logarithm-transformed and the change at Week 26 to baseline (Day 1), expressed as the ratio, was analyzed by an ANCOVA model including treatment, country, and baseline HbA1c stratum (\<9.0% or \>=9.0%) as factors, and baseline value of fasting triglycerides as a covariate. Null hypothesis: no difference across treatments. Power: based on the primary measurement.||0.96|0.82|0.0062
72506740|NCT02202031|144545565|SUPERIORITY||Mean Difference (Final Values)|0.24||||0.6222|TWO_SIDED|95.0|-0.73|1.21|||ANCOVA|change from baseline, adjusted for baseline value||||1.21|-0.73|0.6222
72506741|NCT02202031|144545566|SUPERIORITY||Mean Difference (Final Values)|-0.08||||0.7695|TWO_SIDED|95.0|-0.64|0.47|||ANCOVA|change from baseline, adjusted for baseline value||||0.47|-0.64|0.7695
72506742|NCT02202031|144545567|SUPERIORITY||Mean Difference (Final Values)|0.07||||0.6456|TWO_SIDED|95.0|-0.24|0.39|||ANCOVA|change from baseline value, adjusted for baseline value||||0.39|-0.24|0.6456
72397910|NCT01287897|144301830|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.0|STANDARD_ERROR_OF_MEAN|10.5||0.092|TWO_SIDED|90.0|-3.3|31.3|||GLMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in CDAI-100 response rate for the 50-mg arm at Week 12.||31.3|-3.3|0.0920
72506743|NCT02202031|144545568|SUPERIORITY||Mean Difference (Final Values)|-0.03||||0.919|TWO_SIDED|95.0|-0.66|0.6|||ANCOVA|change from baseline, adjusted for baseline value||||0.60|-0.66|0.9190
72506744|NCT02202031|144545569|SUPERIORITY||Mean Difference (Final Values)|1.16||||0.5358|TWO_SIDED|95.0|-2.51|4.84|||ANCOVA|change from baseline, adjusted for baseline value.||||4.84|-2.51|0.5358
72506745|NCT02202031|144545570|SUPERIORITY||Mean Difference (Final Values)|1.72||||0.4663|TWO_SIDED|95.0|-2.9|6.34|||ANCOVA|change from baseline, adjusted for baseline value||||6.34|-2.90|0.4663
72506746|NCT02202031|144545571|SUPERIORITY||Mean Difference (Final Values)|2.17||||0.3134|TWO_SIDED|95.0|-2.05|6.38|||ANCOVA|change from baseline, adjusted for baseline value||||6.38|-2.05|0.3134
72506747|NCT02202031|144545572|SUPERIORITY||Mean Difference (Final Values)|-1.76||||0.5146|TWO_SIDED|95.0|-7.05|3.53|||ANCOVA|change from baseline, adjusted for baseline value||||3.53|-7.05|0.5146
72506748|NCT02202031|144545573|SUPERIORITY||Mean Difference (Final Values)|-0.14||||0.3611|TWO_SIDED|95.0|-0.44|0.16|||ANCOVA|change from baseline, adjusted for baseline value||||0.16|-0.44|0.3611
72506749|NCT02202031|144545574|SUPERIORITY||Mean Difference (Final Values)|-0.43||||0.6722|TWO_SIDED|95.0|-2.43|1.57|||ANCOVA|change from baseline, adjusted for baseline value||||1.57|-2.43|0.6722
72397911|NCT01287897|144301831|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.7|STANDARD_ERROR_OF_MEAN|6.8||0.4031|TWO_SIDED|90.0|-9.5|12.9|||GLMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in CDAI-100 response rate for the 200-mg arm at Week 2.||12.9|-9.5|0.4031
72397912|NCT01287897|144301831|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.1|STANDARD_ERROR_OF_MEAN|9.6||0.1219|TWO_SIDED|90.0|-4.6|26.8|||GLMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in CDAI-100 response rate for the 200-mg arm at Week 4.||26.8|-4.6|0.1219
72397913|NCT01287897|144301831|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.9|STANDARD_ERROR_OF_MEAN|10.0||0.16|TWO_SIDED|90.0|-6.5|26.4|||GLMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in CDAI-100 response rate for the 200-mg arm at Week 6.||26.4|-6.5|0.1600
72397914|NCT01287897|144301831|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.7|STANDARD_ERROR_OF_MEAN|10.3||0.6019|TWO_SIDED|90.0|-19.5|14.2|||GLMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in CDAI-100 response rate for the 200-mg arm at Week 8.||14.2|-19.5|0.6019
72397915|NCT01287897|144301831|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.3|STANDARD_ERROR_OF_MEAN|12.3||0.1601||90.0|-8.0|32.5|||GLMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in CDAI-100 response rate for the 200-mg arm at Week 10.||32.5|-8.0|0.1601
72397916|NCT01287897|144301831|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.4|STANDARD_ERROR_OF_MEAN|11.7||0.2622|TWO_SIDED|90.0|-11.8|26.6|||GLMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in CDAI-100 response rate for the 200-mg arm at Week 12.||26.6|-11.8|0.2622
72397917|NCT01287897|144301832|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.6|STANDARD_ERROR_OF_MEAN|12.22||0.2173|TWO_SIDED|90.0|-29.8|10.6|||Linear mixed model (LMM)|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in change from baseline in CDAI score for the 10-mg arm at Week 2.||10.6|-29.8|0.2173
72397918|NCT01287897|144301832|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.0|STANDARD_ERROR_OF_MEAN|12.95||0.1778|TWO_SIDED|90.0|-33.4|9.4|||LMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in change from baseline in CDAI score for the 10-mg arm at Week 4.||9.4|-33.4|0.1778
72506750|NCT02202031|144545575|SUPERIORITY||Mean Difference (Final Values)|-0.67||||0.0786|TWO_SIDED|95.0|-1.4|0.07|||ANCOVA|change from baseline, adjusted for baseline value||||0.07|-1.4|0.0786
72506751|NCT02202031|144545576|SUPERIORITY||Mean Difference (Final Values)|-1.04||||0.2284|TWO_SIDED|95.0|-2.87|0.79|||ANCOVA|change from baseline, adjusted for baseline value||||0.79|-2.87|0.2284
72506752|NCT02202031|144545577|SUPERIORITY||Mean Difference (Final Values)|-1.71||||0.0335|TWO_SIDED|95.0|-3.28|-0.13|||ANCOVA|change from baseline, adjusted for baseline value||||-0.13|-3.28|0.0335
72506753|NCT02202031|144545578|SUPERIORITY||Mean Difference (Final Values)|0.08||||0.8408|TWO_SIDED|95.0|-0.66|0.81|||ANCOVA|change from baseline, adjusted for baseline value||||0.81|-0.66|0.8408
72506754|NCT02202031|144545579|SUPERIORITY|adjusted for baseline value, diabetes and the following medications: beta-blockers, alpha-agonists, and sympathomimetic|Mean Difference (Final Values)|0.14||||0.5578|TWO_SIDED|95.0|-0.32|0.6|||ANCOVA|||||0.60|-0.32|0.5578
72397919|NCT01287897|144301832|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.9|STANDARD_ERROR_OF_MEAN|16.37||0.1661|TWO_SIDED|90.0|-43.0|11.2|||LMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in change from baseline in CDAI score for the 10-mg arm at Week 6.||11.2|-43.0|0.1661
72397920|NCT01287897|144301832|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.9|STANDARD_ERROR_OF_MEAN|17.66||0.1993|TWO_SIDED|90.0|-44.1|14.3|||LMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in change from baseline in CDAI score for the 10-mg arm at Week 8.||14.3|-44.1|0.1993
72506755|NCT02202031|144545580|SUPERIORITY|||||||0.5578|||||||ANCOVA|Adjusted for baseline value, diabetes and the following medications: beta-blockers, alpha-agonists, and sympathomimetic.||||||0.5578
72397921|NCT01287897|144301832|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-30.2|STANDARD_ERROR_OF_MEAN|19.66||0.0632|TWO_SIDED|90.0|-62.7|2.3|||LMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in change from baseline in CDAI score for the 10-mg arm at Week 10.||2.3|-62.7|0.0632
72397922|NCT01287897|144301832|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.8|STANDARD_ERROR_OF_MEAN|19.71||0.1975|TWO_SIDED|90.0|-49.4|15.8|||LMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in change from baseline in CDAI score for the 10-mg arm at Week 12.||15.8|-49.4|0.1975
72397923|NCT01287897|144301832|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.7|STANDARD_ERROR_OF_MEAN|12.25||0.5868|TWO_SIDED|90.0|-17.6|22.9|||LMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in change from baseline in CDAI score for the 50-mg arm at Week 2.||22.9|-17.6|0.5868
72397924|NCT01287897|144301832|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-25.7|STANDARD_ERROR_OF_MEAN|12.93||0.0243|TWO_SIDED|90.0|-47.0|-4.3|||LMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in change from baseline in CDAI score for the 50-mg arm at Week 4.||-4.3|-47.0|0.0243
72397925|NCT01287897|144301832|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-22.4|STANDARD_ERROR_OF_MEAN|16.12||0.0834|TWO_SIDED|90.0|-49.0|4.3|||LMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in change from baseline in CDAI score for the 50-mg arm at Week 6.||4.3|-49.0|0.0834
72506756|NCT02202031|144545581|SUPERIORITY||Mean Difference (Final Values)|-0.24||||0.7301|TWO_SIDED|95.0|-0.79|0.31|||ANCOVA|adjusted for baseline value, diabetes and the following medications: beta-blockers, alpha-agonists, and sympathomimetic.||||0.31|-0.79|0.7301
72506757|NCT02202031|144545582|SUPERIORITY||Mean Difference (Final Values)|-0.43||||0.6646|TWO_SIDED|95.0|-0.89|0.04|||ANCOVA|adjusted for baseline value, diabetes and the following medications: beta-blockers, alpha-agonists, and sympathomimetic||||0.04|-0.89|0.6646
72506758|NCT02202031|144545583|SUPERIORITY|||||||0.4993|||||||ANCOVA|Adjusted for baseline value, diabetes and the following medications: beta-blockers, alpha-agonists, and sympathomimetic.||||||0.4993
72472837|NCT03838731|144469159|SUPERIORITY||LS Mean Difference|0.37|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|0.21|0.53|||MMRM|||Day 8||0.53|0.21|< 0.001
72472838|NCT03838731|144469159|SUPERIORITY||LS Mean Difference|0.46|STANDARD_ERROR_OF_MEAN|0.11|<|0.001|TWO_SIDED|95.0|0.23|0.68|||MMRM|||Day 29||0.68|0.23|<0.001
72472839|NCT03838731|144469159|SUPERIORITY||LS Mean Difference|0.34|STANDARD_ERROR_OF_MEAN|0.11|=|0.002|TWO_SIDED|95.0|0.13|0.55|||MMRM|||Day 57||0.55|0.13|= 0.002
72472840|NCT03838731|144469159|SUPERIORITY||LS Mean Difference|0.37|STANDARD_ERROR_OF_MEAN|0.11|=|0.002|TWO_SIDED|95.0|0.15|0.47|||MMRM|||Day 85||0.47|0.15|= 0.002
72472841|NCT03838731|144469160|SUPERIORITY||LS Mean Difference|0.22|STANDARD_ERROR_OF_MEAN|0.53|=|0.675|TWO_SIDED|95.0|-0.85|1.29|||MMRM|||Day 8||1.29|-0.85|= 0.675
72472842|NCT03838731|144469160|SUPERIORITY||LS Mean Difference|-0.68|STANDARD_ERROR_OF_MEAN|0.51|=|0.182|TWO_SIDED|95.0|-1.7|0.33|||MMRM|||Day 29||0.33|-1.70|= 0.182
72472843|NCT03838731|144469160|SUPERIORITY||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.61|=|0.866|TWO_SIDED|95.0|-1.12|1.32|||MMRM|||Day 57||1.32|-1.12|= 0.866
72472844|NCT03838731|144469160|SUPERIORITY||LS Mean Difference|-0.88|STANDARD_ERROR_OF_MEAN|0.6|=|0.146|TWO_SIDED|95.0|-2.08|0.32|||MMRM|||Day 85||0.32|-2.08|= 0.146
72472845|NCT03838731|144469161|SUPERIORITY||LS Mean Difference|0.14|STANDARD_ERROR_OF_MEAN|0.24|=|0.572|TWO_SIDED|95.0|-0.35|0.63|||MMRM|||Day 8||0.63|-0.35|= 0.572
72472846|NCT03838731|144469161|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.2|=|0.997|TWO_SIDED|95.0|-0.41|0.41|||MMRM|||Day 29||0.41|-0.41|= 0.997
72472847|NCT03838731|144469161|SUPERIORITY||LS Mean Difference|0.07|STANDARD_ERROR_OF_MEAN|0.21|=|0.756|TWO_SIDED|95.0|-0.36|0.49|||MMRM|||Day 57||0.49|-0.36|= 0.756
72472848|NCT03838731|144469161|SUPERIORITY||LS Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.15|=|0.333|TWO_SIDED|95.0|-0.46|0.16|||MMRM|||Day 85||0.16|-0.46|= 0.333
72472849|NCT03838731|144469162|SUPERIORITY||LS Mean Difference|39.5|STANDARD_ERROR_OF_MEAN|12.5|=|0.003|TWO_SIDED|95.0|14.36|64.65|||MMRM|||Day 8||64.65|14.36|= 0.003
72472850|NCT03838731|144469162|SUPERIORITY||LS Mean Difference|54.07|STANDARD_ERROR_OF_MEAN|11.97|<|0.001|TWO_SIDED|95.0|30.01|78.12|||MMRM|||Day 29||78.12|30.01|< 0.001
72472851|NCT03838731|144469162|SUPERIORITY||LS Mean Difference|33.44|STANDARD_ERROR_OF_MEAN|14.28|=|0.023|TWO_SIDED|95.0|4.79|62.08|||MMRM|||Day 57||62.08|4.79|= 0.023
72472852|NCT03838731|144469162|SUPERIORITY||LS Mean Difference|41.1|STANDARD_ERROR_OF_MEAN|12.92|=|0.003|TWO_SIDED|95.0|15.1|67.09|||MMRM|||Day 85||67.09|15.10|= 0.003
72472853|NCT03838731|144469163|SUPERIORITY||LS Mean Difference|205.43|STANDARD_ERROR_OF_MEAN|102.09|=|0.049|TWO_SIDED|95.0|0.69|410.17|||MMRM|||Day 8||410.17|0.69|= 0.049
72472854|NCT03838731|144469163|SUPERIORITY||LS Mean Difference|244.6|STANDARD_ERROR_OF_MEAN|99.05|=|0.017|TWO_SIDED|95.0|45.6|443.59|||MMRM|||Day 29||443.59|45.60|= 0.017
72472855|NCT03838731|144469163|SUPERIORITY||LS Mean Difference|183.03|STANDARD_ERROR_OF_MEAN|96.91|=|0.064|TWO_SIDED|95.0|-11.29|377.35|||MMRM|||Day 57||377.35|-11.29|= 0.064
72472856|NCT03838731|144469163|SUPERIORITY||LS Mean Difference|241.01|STANDARD_ERROR_OF_MEAN|114.0|=|0.039|TWO_SIDED|95.0|12.44|469.57|||MMRM|||Day 85||469.57|12.44|= 0.039
72472857|NCT00770029|144469174|SUPERIORITY_OR_OTHER||Difference response rate|0.6|STANDARD_ERROR_OF_MEAN|0.036|<|0.0001|TWO_SIDED|95.0|0.52|0.68|||Fisher Exact|||The efficacy of the treatment was confirmed if H0 was rejected at a given α of 5%, that means if the two sided p-value was ≤0.05. Power of 90%||0.68|0.52|<0.0001
72472858|NCT01294397|144469197|SUPERIORITY_OR_OTHER||Least Squares Mean Ratio of Day 22/Day 1|0.96|||||TWO_SIDED|90.0|0.85|1.08|||||Two one-sided tests|Log-transformed AUC0-168 was analyzed with a mixed-effects model with treatment as the fixed effect and subject as the random effect. The mean difference between day 22 and day 1 was expressed as a percentage of the reference (day 1). The mean differences and the 90% CIs were back transformed to produce the ratio (day 22 vs. day 1) of the geometric means and the 90% CIs. If the CI for the ratio was within the standard acceptance range of 0.80 to 1.25, absence of an interaction was concluded.||1.08|0.85|
72472859|NCT01294397|144469198|SUPERIORITY_OR_OTHER||Least Squares Mean Ratio of Day 22/Day 1|0.92|||||TWO_SIDED|90.0|0.81|1.05|||||Two one-sided tests|Log-transformed Cmax was analyzed with a mixed-effects model with treatment as the fixed effect and subject as the random effect. The mean difference between day 22 and day 1 was expressed as a percentage of the reference (day 1). The mean differences and the 90% CIs were back transformed to produce the ratio (day 22 vs. day 1) of the geometric means and the 90% CIs. If the CI for the ratio was within the standard acceptance range of 0.80 to 1.25, absence of an interaction was concluded.||1.05|0.81|
72472860|NCT01128270|144469229|SUPERIORITY_OR_OTHER||Mean of one group (2A)|1.64|STANDARD_DEVIATION|0.4|||TWO_SIDED|95.0|1.31|1.97||||Analysis applies only to Arm 2A. (Period 3)|Only arm 2A is relevant to this variable. There is no intended statistical comparison, but the point estimate for the mean level and 95% confidence interval are provided.|No comparison is relevant. The statistical method is how we obtained the point estimate and confidence interval. No test was intended.||1.97|1.31|
72472861|NCT01128270|144469230|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2432.0|STANDARD_DEVIATION|1403.0||0.0017|TWO_SIDED|95.0|1260.0|3606.0|||t-test, 2 sided|||Only relevant to Arm 2B.||3606|1260|0.0017
72472862|NCT01128270|144469231|SUPERIORITY_OR_OTHER||Mean|0.38|STANDARD_DEVIATION|0.17|||TWO_SIDED|95.0|0.24|0.51||||||Only relevant for arm 2B||0.51|0.24|
72472863|NCT03596762|144469267|SUPERIORITY||Difference in LS means|-1.52|||=|0.1946|TWO_SIDED|95.0|-3.83|0.78|||Mixed-Effect Model Repeated Measures|||Change from Baseline to Week 4||0.78|-3.83|= 0.1946
72472864|NCT03596762|144469267|SUPERIORITY||Difference in LS means|1.29|||=|0.3682|TWO_SIDED|95.0|-4.11|1.53|||Mixed-Effect Model Repeated Measures|||Change from Baseline to Week 4||1.53|-4.11|= 0.3682
72472865|NCT03596762|144469267|SUPERIORITY||Difference in LS means|-3.93|||=|0.0002|TWO_SIDED|95.0|-5.94|-1.92|||Mixed-Effect Model Repeated Measures|||Change from Baseline to Week 4||-1.92|-5.94|= 0.0002
72472866|NCT03596762|144469267|SUPERIORITY||Difference in LS means|-2.63|||=|0.0115|TWO_SIDED|95.0|-4.66|-0.6|||Mixed-Effect Model Repeated Measures|||Change from Baseline to Week 4||-0.6|-4.66|= 0.0115
72472867|NCT03596762|144469268|SUPERIORITY||Difference in LS means|-1.67|||=|0.2097|TWO_SIDED|95.0|-4.28|-0.95|||Mixed-Effect Model Repeated Measures|||Change from Baseline to Week 12||-0.95|-4.28|= 0.2097
72472868|NCT03596762|144469268|SUPERIORITY||Difference in LS means|-0.77|||=|0.6369|TWO_SIDED|95.0|-3.97|2.44|||Mixed-Effect Model Repeated Measures|||Change from Baseline to Week 12||2.44|-3.97|= 0.6369
72472869|NCT03596762|144469268|SUPERIORITY||Difference in LS means|-2.95|||=|0.0116|TWO_SIDED|95.0|-5.22|-0.67|||Mixed-Effect Model Repeated Measures|||Change from Baseline to Week 12||-0.67|-5.22|= 0.0116
72472870|NCT03596762|144469268|SUPERIORITY||Difference in LS means|-1.78|||=|0.1346|TWO_SIDED|95.0|-4.12|0.56|||Mixed-Effect Model Repeated Measures|||Change from Baseline to Week 12||0.56|-4.12|= 0.1346
72472871|NCT03596762|144469269|SUPERIORITY||Difference in LS means|-0.05|||=|0.7033|TWO_SIDED|95.0|-0.3|0.2|||Mixed-Effect Model Repeated Measures|||Change from Baseline to Week 4||0.2|-0.3|= 0.7033
72472872|NCT03596762|144469269|SUPERIORITY||Difference in LS means|-0.14|||=|0.3724|TWO_SIDED|95.0|-0.45|0.17|||Mixed-Effect Model Repeated Measures|||Change from Baseline to Week 4||0.17|-0.45|= 0.3724
72472873|NCT03596762|144469269|SUPERIORITY||Difference in LS means|-0.19|||=|0.0896|TWO_SIDED|95.0|-0.41|0.03|||Mixed-Effect Model Repeated Measures|||Change from Baseline to Week 4||0.03|-0.41|= 0.0896
72472874|NCT03596762|144469269|SUPERIORITY||Difference in LS means|-0.19|||=|0.09|TWO_SIDED|95.0|-0.41|0.03|||Mixed-Effect Model Repeated Measures|||Change from Baseline to Week 4||0.03|-0.41|= 0.09
72472875|NCT03596762|144469270|SUPERIORITY||Difference in LS means|-0.09|||=|0.5511|TWO_SIDED|95.0|-0.39|0.21|||Mixed-Effect Model Repeated Measures|||Change from Baseline to Week 12||0.21|-0.39|= 0.5511
72472876|NCT03596762|144469270|SUPERIORITY||Difference in LS means|0.16|||=|0.3822|TWO_SIDED|95.0|-0.2|0.52|||Mixed-Effect Model Repeated Measures|||Change from Baseline to Week 12||0.52|-0.2|= 0.3822
72472877|NCT03596762|144469270|SUPERIORITY||Difference in LS means|-0.15|||=|0.2606|TWO_SIDED|95.0|-0.41|0.11|||Mixed-Effect Model Repeated Measures|||Change from Baseline to Week 12||0.11|-0.41|= 0.2606
72472878|NCT03596762|144469270|SUPERIORITY||Difference in LS means|-0.27|||=|0.0479|TWO_SIDED|95.0|-0.53|0.0|||Mixed-Effect Model Repeated Measures|||Change from Baseline to Week 12||0|-0.53|= 0.0479
72506759|NCT02202031|144545584|SUPERIORITY||Mean Difference (Final Values)|0.59||||0.7506|TWO_SIDED|95.0|-3.05|4.23|||ANCOVA|adjusted for baseline value, diabetes and the following medications: beta-blockers, alpha-agonists, and sympathomimetic.||||4.23|-3.05|0.7506
72506760|NCT02202031|144545585|SUPERIORITY||Mean Difference (Final Values)|-1.55||||0.6268|TWO_SIDED|95.0|-6.98|3.87|||ANCOVA|adjusted for baseline value, diabetes and the following medications: beta-blockers, alpha-agonists, and sympathomimetic.||||3.87|-6.98|0.6268
72472879|NCT00895895|144469395|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.7||||0.424|TWO_SIDED|95.0|-1.0|2.3|||Mixed Models Analysis|Mixed Model with repeated measures: change=Mini Mental State Examination (MMSE) Japan baseline baseline times(\*)visit visit treatment treatment\*visit.||Analysis of adjusted difference in change from baseline.||2.3|-1.0|0.424
72472880|NCT00895895|144469395|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2||||0.849|TWO_SIDED|95.0|-1.8|1.5|||Mixed Models Analysis|Mixed Model with repeated measures: change equals (=) MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||1.5|-1.8|0.849
72472881|NCT00895895|144469395|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5||||0.52|TWO_SIDED|95.0|-2.2|1.1|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||1.1|-2.2|0.520
72472882|NCT00895895|144469395|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0||||0.258|TWO_SIDED|95.0|-2.6|0.7|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||0.7|-2.6|0.258
72472883|NCT00895895|144469396|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.6||||0.367|TWO_SIDED|95.0|-5.2|1.9|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||1.9|-5.2|0.367
72472884|NCT00895895|144469396|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2||||0.91|TWO_SIDED|95.0|-3.3|3.7|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||3.7|-3.3|0.910
72472885|NCT00895895|144469396|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.5||||0.16|TWO_SIDED|95.0|-1.0|6.0|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||6.0|-1.0|0.160
72472886|NCT00895895|144469396|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.4||||0.06|TWO_SIDED|95.0|-0.1|6.9|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||6.9|-0.1|0.060
72472887|NCT00895895|144469397|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||0.931|TWO_SIDED|95.0|-2.8|3.1|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||3.1|-2.8|0.931
72472888|NCT00895895|144469397|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.9||||0.054|TWO_SIDED|95.0|-5.8|0.1|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||0.1|-5.8|0.054
72472889|NCT00895895|144469397|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.7||||0.246|TWO_SIDED|95.0|-4.6|1.2|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||1.2|-4.6|0.246
72472890|NCT00895895|144469397|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.2||||0.426|TWO_SIDED|95.0|-4.1|1.7|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||1.7|-4.1|0.426
72472891|NCT00895895|144469398|SUPERIORITY_OR_OTHER|||||||0.265|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.265
72472892|NCT00895895|144469398|SUPERIORITY_OR_OTHER|||||||0.682|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.682
72472893|NCT00895895|144469398|SUPERIORITY_OR_OTHER|||||||0.532|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.532
72506761|NCT00076219|144545586|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.09|STANDARD_ERROR_OF_MEAN|0.12||0.47|TWO_SIDED|95.0|0.86|1.4|||Regression, Logistic|||||1.40|0.86|0.47
72506762|NCT02795767|144545629|OTHER||ABR Ratio|0.01|||||TWO_SIDED|95.0|0.006|0.023|||||Emicizumab QW is the numerator and Prophylactic/Episodic Bypassing Agent is the denominator.|||0.023|0.006|
72506763|NCT02795767|144545630|OTHER||ABR Ratio|0.1|||||TWO_SIDED|95.0|0.051|0.21|||||Emicizumab QW is the numerator and Prophylactic/Episodic Bypassing Agent is the denominator.|||0.210|0.051|
72397926|NCT01287897|144301832|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-28.8|STANDARD_ERROR_OF_MEAN|17.43||0.0499|TWO_SIDED|90.0|-57.7|0.0|||LMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in change from baseline in CDAI score for the 50-mg arm at Week 8.||-0.0|-57.7|0.0499
72472894|NCT00895895|144469398|SUPERIORITY_OR_OTHER|||||||0.087|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.087
72472895|NCT00895895|144469398|SUPERIORITY_OR_OTHER|||||||0.751|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.751
72472896|NCT00895895|144469399|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.7||||0.553|TWO_SIDED|95.0|-3.9|7.3|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||7.3|-3.9|0.553
72472897|NCT00895895|144469399|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4||||0.886|TWO_SIDED|95.0|-6.0|5.2|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||5.2|-6.0|0.886
72472898|NCT00895895|144469399|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0||||0.712|TWO_SIDED|95.0|-6.6|4.5|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||4.5|-6.6|0.712
72472899|NCT00895895|144469399|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.8||||0.785|TWO_SIDED|95.0|-4.8|6.4|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||6.4|-4.8|0.785
72472900|NCT00895895|144469400|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2||||0.251|TWO_SIDED|95.0|-0.5|0.1|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||0.1|-0.5|0.251
72472901|NCT00895895|144469400|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.993|TWO_SIDED|95.0|-0.3|0.3|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||0.3|-0.3|0.993
72506764|NCT02553915|144545659|OTHER|Comparisons were made for each biomarker within each arm pre and post 12 weeks of treatment.|||||<|0.1|||||||Kruskal-Wallis|||To evaluate whether a dose-response relationship exists between dose of EPA and decrease either in plasma IL-6 levels or in mitogen-stimulated PBMC TNF-α expression and secretion, when compared with placebo. \[Time Frame: 12 weeks\]. Comparisons were made within each arm pre and post 12 weeks of treatment.||||<0.10
72506765|NCT02553915|144545660|SUPERIORITY||||||<|0.1|||||||ANOVA|||"To evaluate:~1. whether EPA treatment produces a decrease in ratings of depression severity, when compared with placebo-treated subjects; and~2. whether the changes in IL-6 or mitogen- stimulated PBMC TNF-α expression mediate changes observed in ratings of depression.~\[Time Frame: 12 weeks\]"||||<0.1
72472902|NCT00895895|144469400|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.553|TWO_SIDED|95.0|-0.4|0.2|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||0.2|-0.4|0.553
72472903|NCT00895895|144469400|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.611|TWO_SIDED|95.0|-0.4|0.2|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||0.2|-0.4|0.611
72472904|NCT00895895|144469401|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5||||0.34|TWO_SIDED|95.0|-1.5|0.5|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||0.5|-1.5|0.340
72472905|NCT00895895|144469401|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2||||0.63|TWO_SIDED|95.0|-0.8|1.2|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||1.2|-0.8|0.630
72472906|NCT00895895|144469401|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2||||0.678|TWO_SIDED|95.0|-0.8|1.2|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||1.2|-0.8|0.678
72472907|NCT00895895|144469401|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3||||0.518|TWO_SIDED|95.0|-1.3|0.7|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||0.7|-1.3|0.518
72472908|NCT00895895|144469402|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.953|TWO_SIDED|95.0|-0.7|0.7|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||0.7|-0.7|0.953
72472909|NCT00895895|144469402|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.956|TWO_SIDED|95.0|-0.7|0.6|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||0.6|-0.7|0.956
72472910|NCT00895895|144469402|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4||||0.216|TWO_SIDED|95.0|-1.1|0.2|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||0.2|-1.1|0.216
72472911|NCT00895895|144469402|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.665|TWO_SIDED|95.0|-0.8|0.5|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||0.5|-0.8|0.665
72472912|NCT00895895|144469403|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.5||||0.373|TWO_SIDED|95.0|-0.6|1.7|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||1.7|-0.6|0.373
72472913|NCT00895895|144469403|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2||||0.781|TWO_SIDED|95.0|-1.0|1.3|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||1.3|-1.0|0.781
72472914|NCT00895895|144469403|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.5||||0.417|TWO_SIDED|95.0|-0.7|1.6|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||1.6|-0.7|0.417
72472915|NCT00895895|144469403|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.853|TWO_SIDED|95.0|-1.3|1.0|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||1.0|-1.3|0.853
72472916|NCT00895895|144469404|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7||||0.428|TWO_SIDED|95.0|-2.6|1.1|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||1.1|-2.6|0.428
72472917|NCT00895895|144469404|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3||||0.763|TWO_SIDED|95.0|-2.1|1.5|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||1.5|-2.1|0.763
72472918|NCT00895895|144469404|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9||||0.312|TWO_SIDED|95.0|-2.7|0.9|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||0.9|-2.7|0.312
72472919|NCT00895895|144469404|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.2||||0.215|TWO_SIDED|95.0|-3.0|0.7|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||0.7|-3.0|0.215
72472920|NCT00895895|144469405|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.956|TWO_SIDED|95.0|-2.7|2.5|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||2.5|-2.7|0.956
72472921|NCT00895895|144469405|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.988|TWO_SIDED|95.0|-2.6|2.5|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||2.5|-2.6|0.988
72565809|NCT02709486|144662704|SUPERIORITY||Least Square Mean Difference|-1.01|STANDARD_ERROR_OF_MEAN|0.17|<|0.0001|TWO_SIDED|95.0|-1.35|-0.67|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.||-0.67|-1.35|<.0001
72397927|NCT01287897|144301832|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-44.9|STANDARD_ERROR_OF_MEAN|19.45||0.0111|TWO_SIDED|90.0|-77.1|-12.7|||LMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in change from baseline in CDAI score for the 50-mg arm at Week 10.||-12.7|-77.1|0.0111
72472922|NCT00895895|144469405|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2||||0.89|TWO_SIDED|95.0|-2.7|2.4|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||2.4|-2.7|0.890
72472923|NCT00895895|144469405|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.4||||0.28|TWO_SIDED|95.0|-4.0|1.2|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||1.2|-4.0|0.280
72472924|NCT00895895|144469406|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6||||0.154|TWO_SIDED|95.0|-1.5|0.2|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||0.2|-1.5|0.154
72472925|NCT00895895|144469406|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.74|TWO_SIDED|95.0|-1.0|0.7|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||0.7|-1.0|0.740
72472926|NCT00895895|144469406|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6||||0.179|TWO_SIDED|95.0|-1.4|0.3|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||0.3|-1.4|0.179
72472927|NCT00895895|144469406|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3||||0.543|TWO_SIDED|95.0|-0.6|1.1|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||1.1|-0.6|0.543
72472928|NCT00895895|144469407|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-60.4||||0.861|TWO_SIDED|95.0|-739.7|618.8|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||618.8|-739.7|0.861
72472929|NCT00895895|144469407|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-926.6||||0.007|TWO_SIDED|95.0|-1596.9|-256.3|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||-256.3|-1596.9|0.007
72472930|NCT00895895|144469407|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|141.3||||0.676|TWO_SIDED|95.0|-522.1|804.6|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||804.6|-522.1|0.676
72472931|NCT00895895|144469407|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|230.6||||0.505|TWO_SIDED|95.0|-449.7|910.9|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||910.9|-449.7|0.505
72472932|NCT00895895|144469408|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.8||||0.267|TWO_SIDED|95.0|-2.2|7.8|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||7.8|-2.2|0.267
72397928|NCT01287897|144301832|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-39.5|STANDARD_ERROR_OF_MEAN|19.49||0.0221|TWO_SIDED|90.0|-71.7|-7.3|||LMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in change from baseline in CDAI score for the 50-mg arm at Week 12.||-7.3|-71.7|0.0221
72472933|NCT00895895|144469408|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.6||||0.145|TWO_SIDED|95.0|-1.3|8.6|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||8.6|-1.3|0.145
72472934|NCT00895895|144469408|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.7||||0.139|TWO_SIDED|95.0|-1.2|8.6|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||8.6|-1.2|0.139
72472935|NCT00895895|144469408|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.2||||0.386|TWO_SIDED|95.0|-2.8|7.2|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||7.2|-2.8|0.386
72472936|NCT00895895|144469409|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.2||||0.032|TWO_SIDED|95.0|-2.3|-0.1|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||-0.1|-2.3|0.032
72472937|NCT00895895|144469409|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.6||||0.264|TWO_SIDED|95.0|-0.5|1.7|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||1.7|-0.5|0.264
72472938|NCT00895895|144469409|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||0.893|TWO_SIDED|95.0|-1.0|1.1|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||1.1|-1.0|0.893
72506766|NCT02553915|144545661|OTHER||||||<|0.01|||||||Kruskal-Wallis|||Change in IDS-C30 scores were compared pre and post 12 weeks of treatment with each intervention, within each arm.||||<0.01
72506767|NCT02553915|144545662|OTHER|Exploratory.|||||<|0.1|||||||Spearman Rank Order Correlation|||To evaluate whether EPA treatment produces decreases in mitogen-stimulated PBMC IL-6. \[Time Frame: 12 weeks\] Comparisons were made between pre and post treatment levels in each of the 4 treatment arms.||||<0.1
72397929|NCT01287897|144301833|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.8|STANDARD_ERROR_OF_MEAN|18.27||0.3157|TWO_SIDED|90.0|-39.0|21.4|||LMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in change from baseline in CDAI score for the 200-mg arm at Week 2.||21.4|-39.0|0.3157
72506768|NCT02553915|144545663|OTHER|Exploratory|||||<|0.1|||||||Spearman Rank Order Correlation|||To evaluate whether EPA treatment produces decreases in the expression of inflammation pathway-related genes. \[Time Frame: 12 weeks\] (We evaluated gene expression of IL-6 and TNF-α.)||||<0.1
72506769|NCT00751881|144545712|SUPERIORITY_OR_OTHER||Relative risk reduction (%)|36.3||||0.0001|TWO_SIDED|95.0||||"Step down approach used to adjust for multiplicity:~* H1 tested first~* H2 tested only if the comparison H1 was statistically significant~A priori threshold for statistical significance for both comparisons ≤0.05"|Regression, Poisson||Relative risk reduction with teriflunomide 14 mg compared to placebo|"Null hypothesis:~* H1: No difference between teriflunomide 14 mg and placebo~* H2: No difference between teriflunomide 7 mg and placebo~The study was sized to have 94% power to detect a 25% relative risk reduction in ARR with teriflunomide compared to placebo at a 2-sided 0.05 significance level."||||0.0001
72397930|NCT01287897|144301833|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.8|STANDARD_ERROR_OF_MEAN|18.28||0.4171|TWO_SIDED|90.0|-34.0|26.4|||LMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in change from baseline in CDAI score for the 200-mg arm at Week 4.||26.4|-34.0|0.4171
72472939|NCT00895895|144469409|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.4||||0.525|TWO_SIDED|95.0|-0.7|1.4|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||1.4|-0.7|0.525
72472940|NCT00895895|144469410|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|60.9||||0.056|TWO_SIDED|95.0|-1.6|123.5|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||123.5|-1.6|0.056
72472941|NCT00895895|144469410|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|21.8||||0.488|TWO_SIDED|95.0|-40.0|83.5|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||83.5|-40.0|0.488
72472942|NCT00895895|144469410|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.6||||0.783|TWO_SIDED|95.0|-52.6|69.8|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||69.8|-52.6|0.783
72472943|NCT00895895|144469410|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|17.6||||0.578|TWO_SIDED|95.0|-44.6|79.8|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||79.8|-44.6|0.578
72472944|NCT00895895|144469411|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|31.1||||0.175|TWO_SIDED|95.0|-13.9|76.1|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||76.1|-13.9|0.175
72472945|NCT00895895|144469411|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|21.0||||0.352|TWO_SIDED|95.0|-23.3|65.4|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||65.4|-23.3|0.352
72506770|NCT00751881|144545712|SUPERIORITY_OR_OTHER||Relative Risk Reduction (%)|22.3||||0.0183|TWO_SIDED|95.0||||"Step down approach used to adjust for multiplicity:~* H1 tested first~* H2 tested only if the comparison H1 was statistically significant~A priori threshold for statistical significance for both comparisons ≤0.05"|Regression, Poisson||Relative risk reduction with teriflunomide 7 mg compared to placebo|||||0.0183
72472946|NCT00895895|144469411|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.7||||0.797|TWO_SIDED|95.0|-38.1|49.6|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||49.6|-38.1|0.797
72472947|NCT00895895|144469411|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.9||||0.633|TWO_SIDED|95.0|-55.6|33.9|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||33.9|-55.6|0.633
72472948|NCT00895895|144469412|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|71.2||||0.066|TWO_SIDED|95.0|-4.7|147.0|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||147.0|-4.7|0.066
72472949|NCT00895895|144469412|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|20.0||||0.598|TWO_SIDED|95.0|-54.6|94.7|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||94.7|-54.6|0.598
72472950|NCT00895895|144469412|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.2||||0.766|TWO_SIDED|95.0|-62.9|85.3|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||85.3|-62.9|0.766
72472951|NCT00895895|144469412|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|33.8||||0.378|TWO_SIDED|95.0|-41.5|109.1|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||109.1|-41.5|0.378
72472952|NCT00895895|144469413|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|22.5||||0.481|TWO_SIDED|95.0|-40.2|85.2|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||85.2|-40.2|0.481
72506771|NCT00751881|144545713|SUPERIORITY_OR_OTHER||Hazard ratio reduction (%)|31.5||||0.0442|TWO_SIDED|95.0||||"Step down approach:~* S1 tested only if both comparisons on the primary outcome measure were statistically significant~* S2 tested only if the comparison S1 was statistically significant~A priori threshold for statistical significance ≤0.05"|Log Rank|Two-sided Log-rank test stratified by region of enrollment and baseline EDSS stratum|Relative reduction in the hazard rate with teriflunomide 14 mg compared to placebo (estimated from a Cox proportional hazard model with treatment arm, region of enrollment and baseline EDSS stratum as covariates)|"Null hypothesis:~* S1: No difference between teriflunomide 14 mg and placebo~* S2: No difference between teriflunomide 7 mg and placebo~The study was also sized to have 75% power to detect a 37% hazard ratio reduction in time to disability progression with teriflunomide compared to placebo."||||0.0442
72506772|NCT00751881|144545713|SUPERIORITY_OR_OTHER||Hazard ratio reduction (%)|4.5||||0.762|TWO_SIDED|95.0||||"Step down approach:~* S1 tested only if both comparisons on the primary outcome measure were statistically significant~* S2 tested only if the comparison S1 was statistically significant~A priori threshold for statistical significance ≤0.05"|Log Rank|Two-sided Log-rank test stratified by region of enrollment and baseline EDSS stratum|Relative reduction in the hazard rate with teriflunomide 7 mg compared to placebo (estimated from a Cox proportional hazard model with treatment arm, region of enrollment and baseline EDSS stratum as covariates)|||||0.7620
72506773|NCT03415464|144545748|OTHER|||||||0.134|||||||Chi-squared|||||||0.134
72623041|NCT02904096|144776392|OTHER||||||<|0.001|||||||t-test, 1 sided|||Comparison between Group B: (Right Hand)-baseline and Group B: (Right Hand)-change from baseline at Month 24.||||<.001
72472953|NCT00895895|144469413|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.2||||0.894|TWO_SIDED|95.0|-57.5|65.9|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||65.9|-57.5|0.894
72472954|NCT00895895|144469413|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3||||0.991|TWO_SIDED|95.0|-61.5|60.8|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||60.8|-61.5|0.991
72472955|NCT00895895|144469413|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-25.5||||0.422|TWO_SIDED|95.0|-87.9|36.9|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||36.9|-87.9|0.422
72472956|NCT00895895|144469414|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.73||||0.581|TWO_SIDED|95.0|0.24|2.22|||Regression, Logistic|||||2.22|0.24|0.581
72506774|NCT02273323|144545757|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.23||||0.43|TWO_SIDED|0.23|-0.37|0.83|||Mixed Models Analysis|||Estimated effect of tea vs placebo||0.83|-0.37|0.43
72623042|NCT02904096|144776393|OTHER||||||<|0.001|||||||t-test, 1 sided|||Comparison between Group A: (Left Hand)-baseline and Group A: (Left Hand)-change from baseline at Month 24.||||<.001
72472957|NCT00895895|144469414|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.16||||0.77|TWO_SIDED|95.0|0.42|3.19|||Regression, Logistic|||||3.19|0.42|0.770
72472958|NCT00895895|144469414|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.8||||0.216|TWO_SIDED|95.0|0.71|4.55|||Regression, Logistic|||||4.55|0.71|0.216
72472959|NCT00895895|144469414|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.61||||0.037|TWO_SIDED|95.0|1.06|6.42|||Regression, Logistic|||||6.42|1.06|0.037
72472960|NCT00504777|144469416|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
72472961|NCT00504777|144469419|SUPERIORITY_OR_OTHER|||||||0.0054|||||||t-test, 2 sided|||||||0.0054
72472962|NCT03995316|144469437|SUPERIORITY||Slope|-0.76|STANDARD_ERROR_OF_MEAN|0.25||0.003|TWO_SIDED||||||t-test, 2 sided||The slope value reflects the mean difference between conditions in the linear slope from the pretest to posttest assessment.|||||.003
72472963|NCT03995316|144469438|SUPERIORITY||Slope|-0.18|STANDARD_ERROR_OF_MEAN|0.17||0.283|TWO_SIDED||||||t-test, 2 sided||The slope value reflects the mean difference between conditions in the linear slope from the pretest to posttest assessment.|||||.283
72472964|NCT03995316|144469439|SUPERIORITY||Slope|-0.51|STANDARD_ERROR_OF_MEAN|0.22||0.019|TWO_SIDED||||||t-test, 2 sided||The slope value reflects the mean difference between conditions in the linear slope from the pretest to posttest assessment.|||||.019
72565810|NCT02709486|144662704|SUPERIORITY||Least Square Mean Difference|-0.75|STANDARD_ERROR_OF_MEAN|0.18|<|0.0001|TWO_SIDED|95.0|-1.11|-0.39|||ANCOVA|||Week 12: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.||-0.39|-1.11|<.0001
72472965|NCT03995316|144469440|SUPERIORITY||Slope|0.34|STANDARD_ERROR_OF_MEAN|0.44||0.44|TWO_SIDED||||||t-test, 2 sided||The slope value reflects the mean difference between conditions in the linear slope from the pretest to posttest assessment.|||||.440
72472966|NCT03995316|144469441|SUPERIORITY||Slope|-0.06|STANDARD_ERROR_OF_MEAN|0.03||0.055|TWO_SIDED||||||t-test, 2 sided||The slope value reflects the mean difference between conditions in the linear slope from the pretest to posttest assessment.|||||.055
72472967|NCT03995316|144469442|SUPERIORITY||Slope|0.08|STANDARD_ERROR_OF_MEAN|0.04||0.041|TWO_SIDED||||||t-test, 2 sided||The slope value reflects the mean difference between conditions in the linear slope from the pretest to posttest assessment.|||||.041
72472968|NCT03168542|144469509|SUPERIORITY|Superiority was concluded if the lower 95% of the confidence limit of the proportion of subjects who require no more than one modification was greater than 50%.|Proportion|0.952|||||TWO_SIDED|95.0|0.756|1.0|||Agresti-Coull confidence interval|Agresti-Coull method was used to estimate the confidence interval of the binomial proportions.||||1.000|0.756|
72472969|NCT03197766|144469543|SUPERIORITY||||||<|0.0001||||||Confirmatory statistical testing controlling for the Type I error rate was performed on the primary analysis for the primary endpoint.|ANCOVA|Two subjects in the BMN 111 group discontinued from the study before Week 52. The values for these 2 subjects were imputed for this analysis.||||||< 0.0001
72472970|NCT03197766|144469544|SUPERIORITY||||||<|0.0001||||||Confirmatory statistical testing controlling for the Type I error rate was performed on the primary analyses for the two key secondary endpoints.|ANCOVA|Missing assessments at Week 52 were imputed||||||< 0.0001
72472971|NCT03197766|144469545|SUPERIORITY||||||=|0.506||||||Confirmatory statistical testing controlling for the Type I error rate was performed on the primary analyses for the two key secondary endpoints.|ANCOVA|Missing assessments at Week 52 were imputed||||||= 0.506
72472972|NCT00672737|144469547|SUPERIORITY_OR_OTHER||Slope|0.0025|||<|0.05|TWO_SIDED|95.0|0.0009|0.0041|||Regression, Linear|Adjusted for body mass index, age of the volunteers, and a binary variable indicating the type (home-based vs. in-laboratory).|Mixed linear regression|Beta for IGFBP-1: for every 1-pg/mL increase in its serum level the cold pain threshold will additionally increase by 0.0025 seconds for every 1-mcg/mL increase in the plasma level of remifentanil.||0.0041|0.0009|<0.05
72565811|NCT02709486|144662704|SUPERIORITY||Least Square Mean Difference|-0.87|STANDARD_ERROR_OF_MEAN|0.18|<|0.0001|TWO_SIDED|95.0|-1.23|-0.51|||ANCOVA|||Week 12: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.||-0.51|-1.23|<.0001
72472973|NCT00672737|144469547|SUPERIORITY_OR_OTHER||Slope|-0.9694||||0.05|TWO_SIDED|95.0|-1.9127|-0.0261|||Regression, Linear|Adjusted for body mass index, age of the volunteers, and a binary variable indicating the type (home-based vs. in-laboratory).|Mixed linear regression|Beta for SaO2: for every 1-%-absolute decrease in the nadir SaO2 the cold pain threshold will additionally increase by 0.9694 seconds for every 1-mcg/mL increase in the plasma level of remifentanil.||-0.0261|-1.9127|0.05
72472974|NCT00672737|144469548|SUPERIORITY_OR_OTHER||Slope|-0.0001|||<|0.05|TWO_SIDED|95.0|-0.0001|-0.0001|||Regression, Linear|Adjusted for body mass index, age of the volunteers, and a binary variable indicating the type (home-based vs. in-laboratory).|Mixed linear regression|Beta for IGFBP-1: for every 1-pg/mL increase in its serum level, the heat pain threshold will additionally decrease by 0.0001 'C for every 1-mcg/mL increase in the plasma level of remifentanil.||-0.0001|-0.0001|<0.05
72472975|NCT00672737|144469548|SUPERIORITY_OR_OTHER||Slope|-0.0172|||<|0.05|TWO_SIDED|95.0|-0.018|0.0556|||Regression, Linear|Adjusted for body mass index, age of the volunteers, and a binary variable indicating the type (home-based vs. in-laboratory).|Mixed linear regression|Beta for SaO2: for every 1-%-absolute decrease in the nadir SaO2, the heat pain threshold will additionally increase by 0.0172 'C for every 1-mcg/mL increase in the plasma level of remifentanil.||0.0556|-0.018|<0.05
72472976|NCT00972322|144469551|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.34|STANDARD_ERROR_OF_MEAN|8.7||0.083|TWO_SIDED|90.0|-29.87|-0.82|||Least Squares Means Difference||Placebo - MK-8245 on Day 28|||-0.82|-29.87|0.083
72472977|NCT01460225|144469558|EQUIVALENCE|Based on the results of Camilleri et al, this should be adequate to detect up to a 30% difference in gastric emptying scan times with a p-value of 0.05 and 80% power.||||||0.003|||||||t-test, 2 sided|||Comparison of meal retention between pre-treatment and post treatment at 2 hours post meal||||0.003
72472978|NCT01460225|144469558|EQUIVALENCE|Based on the results of Camilleri et al, this should be adequate to detect up to a 30% difference in gastric emptying scan times with a p-value of 0.05 and 80% power.||||||0.122|||||||t-test, 2 sided|||Comparison of meal retention between pre-treatment and post treatment at 4 hours post meal||||0.122
72472979|NCT03852719|144469576|OTHER||Difference in percentages|46.0|||<|0.0001|TWO_SIDED|96.0|30.5|61.4||Fisher's exact test was used for comparison of bulevirtide 10 mg versus Delayed Treatment using a significance level of 0.04 at Week 48.|Fisher Exact|||||61.4|30.5|<0.0001
72472980|NCT03852719|144469576|OTHER||Difference in percentages|42.9|||<|0.0001|TWO_SIDED|96.0|27.0|58.5||Fisher's exact test was used for comparison of bulevirtide 2 mg versus Delayed Treatment using a significance level of 0.04 at Week 48.|Fisher Exact|||||58.5|27.0|<0.0001
72472981|NCT03852719|144469577|OTHER||Difference in percentages|7.8||||0.4139|TWO_SIDED|96.0|-8.5|24.3||Fisher's exact test was used for the comparison of bulevirtide 10 mg versus bulevirtide 2 mg using a significance level of 0.04 at Week 48.|Fisher Exact|||||24.3|-8.5|0.4139
72472982|NCT03852719|144469578|OTHER||Difference in percentages|39.3|||<|0.0001|TWO_SIDED|95.0|20.0|55.8||Fisher's exact test was used for comparison of bulevirtide 2 mg versus Delayed treatment using a significance level of 0.05.|Fisher Exact|||||55.8|20.0|<0.0001
72623043|NCT02904096|144776393|OTHER||||||<|0.001|||||||t-test, 1 sided|||Comparison between Group A: (Right Hand)-baseline and Group A: (Right Hand)-change from baseline at Month 24.||||<.001
72472983|NCT03852719|144469578|OTHER||Difference in percentage|44.2|||<|0.0001|TWO_SIDED|95.0|25.8|59.9||Fisher's exact test was used for comparison of bulevirtide 10 mg versus Delayed treatment using a significance level of 0.05.|Fisher Exact|||||59.9|25.8|<0.0001
72472984|NCT03852719|144469579|OTHER||Difference in LS Mean|-4.02||||0.001|TWO_SIDED|95.0|-6.39|-1.65|||ANCOVA|||||-1.65|-6.39|0.0010
72472985|NCT03852719|144469579|OTHER||Difference in LS Mean|-3.93||||0.0009|TWO_SIDED|95.0|-6.23|-1.63|||ANCOVA|||||-1.63|-6.23|0.0009
72472986|NCT03852719|144469580|OTHER||Difference in Least Square (LS) Mean|0.57||||0.5156|TWO_SIDED|95.0|-1.16|2.3|||MMRM|||||2.30|-1.16|0.5156
72472987|NCT03852719|144469581|OTHER||Difference in Least Square (LS) Mean|-1.21||||0.2977|TWO_SIDED|95.0|-3.5|1.08|||MMRM|||||1.08|-3.50|0.2977
72472988|NCT03852719|144469582|SUPERIORITY||LS-Mean of Diffrence|-0.04||||0.9719|TWO_SIDED|95.0|-2.23|2.15||P-value was based on the mixed-effects model for repeated measurements (MMRM) model.|MMRM||Least squares (LS) means, standard errors (SE), 95% CIs and p-values were based on the mixed-effects model for repeated measurements (MMRM) model for change from baseline.|||2.15|-2.23|0.9719
72472989|NCT03852719|144469583|SUPERIORITY|P-value was based on the mixed-effects model for repeated measurements (MMRM) model.|LS-Mean of Difference|2.11||||0.2369|TWO_SIDED|95.0|-1.41|5.63|||MMRM||Least squares (LS) means, standard errors (SE), 95% CIs and p-values were based on the mixed-effects model for repeated measurements (MMRM) model for change from baseline.|||5.63|-1.41|0.2369
72506775|NCT02273323|144545758|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.71||||0.2|TWO_SIDED|95.0|-0.4|1.82|||Mixed Models Analysis|Subject=random factor; treatment, on/off medication, period = fixed effects||Estimated effect of tea vs. placebo||1.82|-0.40|0.20
72506776|NCT02273323|144545759|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.35|||||TWO_SIDED|95.0|-5.26|2.55|||Mixed Models Analysis|||||2.55|-5.26|
72623044|NCT02904096|144776393|OTHER||||||<|0.001|||||||t-test, 1 sided|||Comparison between Group B: (Left Hand)-baseline and Group B: (Left Hand)-change from baseline at Month 24.||||<.001
72472990|NCT03852719|144469584|SUPERIORITY||Response Rate Difference|7.6||||0.4695|TWO_SIDED|95.0|-9.6|24.4||P-value was based on Fisher's Exact Test.|Fisher Exact||For response rate difference, the 95% exact unconditional confidence interval (CI) based on the score statistic was presented.|||24.4|-9.6|0.4695
72472991|NCT03852719|144469584|SUPERIORITY||Response Rate Difference|-0.4||||1|TWO_SIDED|95.0|-16.3|15.5||P-value was based on Fisher's Exact Test.|Fisher Exact||For response rate difference, the 95% exact unconditional confidence interval (CI) based on the score statistic was presented|||15.5|-16.3|1.0000
72472992|NCT03852719|144469585|SUPERIORITY||Response Rate Difference|7.7||||0.4539|TWO_SIDED|95.0|-8.8|24.0||P-value was based on Fisher's Exact Test.|Fisher Exact||For response rate difference, the 95% exact unconditional confidence interval (CI) based on the score statistic was presented|||24.0|-8.8|0.4539
72472993|NCT03852719|144469585|SUPERIORITY||Response Rate Difference|-0.3||||1|TWO_SIDED|95.0|-15.6|15.5||P-value was based on Fisher's Exact Test.|Fisher Exact||For response rate difference, the 95% exact unconditional confidence interval (CI) based on the score statistic was presented.|||15.5|-15.6|1.0000
72472994|NCT02819024|144469597|OTHER|||||||0.087|||||||t-test, 2 sided|||||||0.087
72472995|NCT03832595|144469611|EQUIVALENCE|We determined that 1,653 patients provide 80% power to detect a hazard ratio of 0.64, or a 5% absolute risk reduction in intervention arm, assuming a primary end-point rate of 15% in the usual care group at 24 months, 20% loss to follow-up, α = 0.05, and within-practice intra-class correlation of 0.01|Hazard Ratio (HR)|0.96||||0.82|TWO_SIDED|95.0|0.67|1.38|||Mixed Models Analysis|||||1.38|0.67|0.82
72472996|NCT03832595|144469612|EQUIVALENCE|α = 0.05|Slope difference|0.011|||||TWO_SIDED|95.0|-0.008|0.029||||||||0.029|-0.008|
72472997|NCT03832595|144469613|EQUIVALENCE|α = 0.05|Rate ratio|1.21|||||TWO_SIDED|95.0|1.02|1.43||||||||1.43|1.02|
72506777|NCT02273323|144545760|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|||||TWO_SIDED|95.0|-2.16|1.37|||Mixed Models Analysis|||||1.37|-2.16|
72506778|NCT02273323|144545761|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.89|||||TWO_SIDED|95.0|-4.65|0.87|||Mixed Models Analysis|||||0.87|-4.65|
72506779|NCT02273323|144545762|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.68|||||TWO_SIDED|95.0|-0.73|4.09|||Mixed Models Analysis|||||4.09|-0.73|
72472998|NCT03832595|144469614|EQUIVALENCE|α = 0.05|Rate ratio|0.8|||||TWO_SIDED|95.0|0.51|1.25||||||||1.25|0.51|
72472999|NCT03832595|144469615|EQUIVALENCE|α = 0.05|Rate ratio|1.18|||||TWO_SIDED|95.0|0.03|53.78||||||||53.78|0.03|
72473000|NCT03832595|144469616|EQUIVALENCE|α = 0.05|Rate ratio|1.12|||||TWO_SIDED|95.0|0.12|9.96||||||||9.96|0.12|
72473001|NCT03238963|144469663|OTHER||Risk Difference (RD)|0.057|STANDARD_ERROR_OF_MEAN|0.039|||TWO_SIDED|95.0|-0.053|0.192|||Chan and Zhang method|95% confidence interval was calculating using the Chan and Zhang method.|Risk difference of BI 1467335 10 milligram (mg) group minus Placebo group.|||0.192|-0.053|
72473002|NCT04421950|144469751|OTHER||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
72473003|NCT01725126|144469808|OTHER|The analysis used an Estimation approach. No hypothesis testing was performed.|Mean Difference (Final Values)|0.19|||||TWO_SIDED|95.0|-1.38|1.75|||ANCOVA|Repeated measures analysis of variance was used with terms for treatment, visit, treatment by visit interaction and Baseline.|Point estimate was calculated as difference in least squares means: Part B-GSK2890457+Liraglutide minus Part B-Placebo+Liraglutide.|Part B-Placebo+Liraglutide versus Part B-GSK2890457+Liraglutide for Day 42 change from Baseline in body weight.||1.75|-1.38|
72506780|NCT03117049|144545766|SUPERIORITY||Hazard Ratio (HR)|0.56|||<|0.0001|TWO_SIDED|96.37|0.43|0.71|||Stratified log-rank test|||||0.71|0.43|<0.0001
72506781|NCT03117049|144545767|SUPERIORITY||Stratified hazard ratio|0.85|||||TWO_SIDED|95.0|0.63|1.14||||||||1.14|0.63|
72506782|NCT03117049|144545768|SUPERIORITY||Odds Ratio (OR)|1.55|||||TWO_SIDED|95.0|1.11|2.17||||||||2.17|1.11|
72506783|NCT03117049|144545769|SUPERIORITY||Odds Ratio (OR)|0.77|||||TWO_SIDED|95.0|0.46|1.31||||||||1.31|0.46|
72506784|NCT00839098|144545772|SUPERIORITY_OR_OTHER|||||||0.27|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.27
72506785|NCT00839098|144545773|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||>0.05
72506786|NCT00839098|144545774|SUPERIORITY_OR_OTHER|||||||0.04|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.04
72506787|NCT00839098|144545775|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||>0.05
72623045|NCT02904096|144776393|OTHER||||||<|0.001|||||||t-test, 1 sided|||Comparison between Group B: (Right Hand)-baseline and Group B: (Right Hand)-change from baseline at Month 24.||||<.001
72397931|NCT01287897|144301833|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.6|STANDARD_ERROR_OF_MEAN|18.79||0.3837|TWO_SIDED|90.0|-36.6|25.5|||LMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in change from baseline in CDAI score for the 200-mg arm at Week 6.||25.5|-36.6|0.3837
72397932|NCT01287897|144301833|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.0|STANDARD_ERROR_OF_MEAN|19.27||0.3204|TWO_SIDED|90.0|-40.8|22.8|||LMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in change from baseline in CDAI score for the 200-mg arm at Week 8.||22.8|-40.8|0.3204
72397933|NCT01287897|144301833|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-29.9|STANDARD_ERROR_OF_MEAN|19.64||0.0649|TWO_SIDED|90.0|-62.3|2.6|||LMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in change from baseline in CDAI score for the 200-mg arm at Week 10.||2.6|-62.3|0.0649
72397934|NCT01287897|144301833|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-31.0|STANDARD_ERROR_OF_MEAN|19.87||0.0598|TWO_SIDED|90.0|-63.9|1.8|||LMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in change from baseline in CDAI score for the 200-mg arm at Week 12.||1.8|-63.9|0.0598
72397935|NCT00065507|144301838|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.74|||<|0.0001|TWO_SIDED|95.0|-2.3|-1.18|||Regression, Linear|Linear regression model adjusted for baseline HBV DNA and LVDr status.||||-1.18|-2.30|<0.0001
72397936|NCT00065507|144301839|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.4|||<|0.0001|TWO_SIDED|95.0|-1.85|-0.96|||Regression, Linear|adjusted for baseline HBV DNA and LVDr Status||||-0.96|-1.85|<0.0001
72397937|NCT00065507|144301840|SUPERIORITY_OR_OTHER||Mean Percent Difference|32.7|||<|0.0001|TWO_SIDED|95.0|20.2|45.2|||Cochran-Mantel-Haenszel|||||45.2|20.2|<0.0001
72623046|NCT02904096|144776394|OTHER||||||<|0.001|||||||t-test, 1 sided|||Comparison between Group A: Hand grip strength (Left Hand)-baseline and Group A: Hand grip strength (Left Hand)-change from baseline at Month 24.||||<.001
72397938|NCT00065507|144301841|SUPERIORITY_OR_OTHER||Mean percent treatment difference|38.0|||<|0.0001|TWO_SIDED|95.0|24.8|50.3|||Cochran-Mantel-Haenszel|||||50.3|24.8|<0.0001
72397939|NCT00065507|144301842|SUPERIORITY_OR_OTHER||percent treatment difference|19.2||||0.0193|TWO_SIDED|95.0|3.7|34.6|||Cochran-Mantel-Haenszel|||Week 24 treatment difference||34.6|3.7|0.0193
72397940|NCT00065507|144301842|SUPERIORITY_OR_OTHER||percent treatment difference|16.4||||0.0425|TWO_SIDED|95.0|0.9|32.0|||Cochran-Mantel-Haenszel|||Week 48 treatment difference||32.0|0.9|0.0425
72397941|NCT00065507|144301848|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.41||||0.51|TWO_SIDED|95.0|-1.63|0.82|||Regression, Linear|Model estimate incorporates prognostic factors measured at baseline. Adjusted for baseline||Covariate adjusted model for MELD score at Week 24||0.82|-1.63|0.51
72397942|NCT00065507|144301848|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.59|||<|0.0001|TWO_SIDED|95.0|-1.08|1.88|||Regression, Linear|Model estimate incorporates prognostic factors measured at baseline. Adjusted for baseline||Covariate adjusted model for MELD score at Week 48||1.88|-1.08|<0.0001
72397943|NCT00065507|144301856|SUPERIORITY_OR_OTHER||Difference Estimate|10.4|||||TWO_SIDED|95.0|-4.5|25.2||||||Difference estimate ETV - ADV at Week 48||25.2|-4.5|
72397944|NCT00065507|144301857|SUPERIORITY_OR_OTHER||Difference Estimate|-0.4|||||TWO_SIDED|95.0|-8.7|8.0||||||Difference Estimate at Week 48||8.0|-8.7|
72397945|NCT00065507|144301858|SUPERIORITY_OR_OTHER||Difference Estimate|-7.2|||||TWO_SIDED|95.0|-21.3|6.9||||||Difference Estimate at Week 48||6.9|-21.3|
72397946|NCT00065507|144301859|SUPERIORITY_OR_OTHER||Difference Estimate|5.7|||||TWO_SIDED|95.0|-0.3|11.7||||||Difference Estimate at Week 48||11.7|-0.3|
72397947|NCT00065507|144301860|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.74||||0.2|TWO_SIDED|95.0|0.46|1.18|||Regression, Cox|Cox proportional hazard model, adjusted for age \<=45 versus age \>45 years, gender, and race (white versus non-white).||treatment comparison of HCC-free survival at Week 48||1.18|0.46|0.20
72397948|NCT01042236|144301892|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.61|STANDARD_ERROR_OF_MEAN|0.88||0.4907|TWO_SIDED|95.0|-1.18|2.41||A treatment by period interaction term (fixed effect) was included if significant at 10% significance level.|ANCOVA|||Change from baseline (prior to Period 1) at the end of the treatment period was analyzed using an analysis of covariance (ANCOVA) model, with fixed effect terms for sequence, period and treatment, using baseline (prior to Period 1) as a covariate, and participant within sequence as a random effect.||2.41|-1.18|0.4907
72397949|NCT01042236|144301892|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.47|STANDARD_ERROR_OF_MEAN|0.88||0.5944|TWO_SIDED|95.0|-2.27|1.32||A treatment by period interaction term (fixed effect) was included if significant at 10% significance level.|ANCOVA|||Change from baseline (prior to Period 1) at the end of the treatment period was analyzed using an analysis of covariance (ANCOVA) model, with fixed effect terms for sequence, period and treatment, using baseline (prior to Period 1) as a covariate, and participant within sequence as a random effect.||1.32|-2.27|0.5944
72397950|NCT01042236|144301893|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.94||0.987|TWO_SIDED|95.0|-1.91|1.94||A treatment by period interaction term (fixed effect) was included if significant at 10% significance level.|ANCOVA|||Change from baseline (prior to Period 1) at the end of the treatment period was analyzed using an analysis of covariance (ANCOVA) model, with fixed effect terms for sequence, period and treatment, using baseline (prior to Period 1) as a covariate, and participant within sequence as a random effect.||1.94|-1.91|0.9870
72473004|NCT01725126|144469808|OTHER|The analysis used an Estimation approach. No hypothesis testing was performed.|Mean Difference (Final Values)|1.08|||||TWO_SIDED|95.0|-0.2|2.36|||ANCOVA|Repeated measures analysis of variance was used with terms for treatment, visit, treatment by visit interaction and Baseline.|Point estimate was calculated as difference in least squares means: Part C-GSK2890457+Metformin minus Part C-Placebo+Metformin.|Part C-Placebo+Metformin versus Part C-GSK2890457+Metformin for Day 42 change from Baseline in body weight.||2.36|-0.20|
72506788|NCT00839098|144545776|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||>0.05
72506789|NCT00839098|144545777|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||P values below 0.05 were considered statistically significant in this study.|Wilcoxon (Mann-Whitney)|||||||>0.05
72506790|NCT00839098|144545778|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||>0.05
72473005|NCT01725126|144469809|OTHER|The analysis used an Estimation approach. No hypothesis testing was performed.|Mean Difference (Final Values)|0.11|||||TWO_SIDED|95.0|-1.64|1.87|||ANCOVA|Repeated measures analysis of variance was used with terms for treatment, visit, treatment by visit interaction and Baseline.|Point estimate was calculated as difference in least squares means: Part B-GSK2890457+Liraglutide minus Part B-Placebo+Liraglutide.|Part B-Placebo+Liraglutide versus Part B-GSK2890457+Liraglutide for Day 42 percent change from Baseline in body weight.||1.87|-1.64|
72473006|NCT01725126|144469809|OTHER|The analysis used an Estimation approach. No hypothesis testing was performed.|Mean Difference (Final Values)|1.26|||||TWO_SIDED|95.0|-0.24|2.75|||ANCOVA|Repeated measures analysis of variance was used with terms for treatment, visit, treatment by visit interaction and Baseline.|Point estimate was calculated as difference in least squares means: Part C-GSK2890457+Metformin minus Part C-Placebo+Metformin.|Part C-Placebo+Metformin versus Part C-GSK2890457+Metformin for Day 42 percent change from Baseline in body weight.||2.75|-0.24|
72473007|NCT01725126|144469810|OTHER|The analysis used an Estimation approach. No hypothesis testing was performed.|Mean Difference (Final Values)|-0.182|||||TWO_SIDED|95.0|-1.694|1.331|||ANCOVA|Terms for treatment and Baseline were included in the model.|Point estimate was calculated as difference in least squares means: Part B-GSK2890457+Liraglutide minus Part B-Placebo+Liraglutide.|Part B-Placebo+Liraglutide versus Part B-GSK2890457+Liraglutide for Day 42 change from Baseline in AUC (0-4 hour) weighted mean glucose.||1.331|-1.694|
72473008|NCT01725126|144469810|OTHER|The analysis used an Estimation approach. No hypothesis testing was performed.|Mean Difference (Final Values)|-0.356|||||TWO_SIDED|95.0|-1.409|0.698|||ANCOVA|Terms for treatment and Baseline were included in the model.|Point estimate was calculated as difference in least squares means: Part B-GSK2890457+Liraglutide minus Part B-Placebo+Liraglutide.|Part B-Placebo+Liraglutide versus Part B-GSK2890457+Liraglutide for Day 42 change from Baseline in AUC (0-24 hour) weighted mean glucose.||0.698|-1.409|
72473009|NCT01725126|144469810|OTHER|The analysis used an Estimation approach. No hypothesis testing was performed.|Mean Difference (Final Values)|-0.853|||||TWO_SIDED|95.0|-2.232|0.526|||ANCOVA|Terms for treatment and Baseline were included in the model.|Point estimate was calculated as difference in least squares means: Part C-GSK2890457+Metformin minus Part C-Placebo+Metformin.|Part C-Placebo+Metformin versus Part C-GSK2890457+Metformin for Day 42 change from Baseline in AUC (0-4 hour) weighted mean glucose.||0.526|-2.232|
72473010|NCT01725126|144469810|OTHER|The analysis used an Estimation approach. No hypothesis testing was performed.|Mean Difference (Final Values)|-1.219|||||TWO_SIDED|95.0|-2.447|0.009|||ANCOVA|Terms for treatment and Baseline were included in the model.|Point estimate was calculated as difference in least squares means: Part C-GSK2890457+Metformin minus Part C-Placebo+Metformin.|Part C-Placebo+Metformin versus Part C-GSK2890457+Metformin for Day 42 change from Baseline in AUC (0-24 hour) weighted mean glucose.||0.009|-2.447|
72473011|NCT01725126|144469811|OTHER|The analysis used an Estimation approach. No hypothesis testing was performed.|Mean Difference (Final Values)|0.155|||||TWO_SIDED|95.0|-1.277|1.587|||ANCOVA|Terms for treatment and Baseline were included in the model.|Point estimate was calculated as difference in least squares means: Part B-GSK2890457+Liraglutide minus Part B -Placebo+Liraglutide.|Part B-Placebo+Liraglutide versus Part B-GSK2890457+Liraglutide for Day 42 change from Baseline in fasting glucose.||1.587|-1.277|
72473012|NCT01725126|144469811|OTHER|The analysis used an Estimation approach. No hypothesis testing was performed.|Mean Difference (Final Values)|-0.524|||||TWO_SIDED|95.0|-1.939|0.892|||ANCOVA|Terms for treatment and Baseline were included in the model.|Point estimate was calculated as difference in least squares means: Part C-GSK2890457+Metformin minus Part C-Placebo+Metformin.|Part C-Placebo+Metformin versus Part C-GSK2890457+Metformin for Day 42 change from Baseline in fasting glucose.||0.892|-1.939|
72473013|NCT01725126|144469813|OTHER|The analysis used an Estimation approach. No hypothesis testing was performed.|Mean Difference (Final Values)|-0.065|||||TWO_SIDED|95.0|-0.495|0.365|||ANCOVA|Terms for treatment and Baseline were included in the model.|Point estimate was calculated as difference in least squares means: Part B-GSK2890457+Liraglutide minus Part B-Placebo+Liraglutide.|Part B-Placebo+Liraglutide versus Part B-GSK2890457+Liraglutide for Day 42 change from Baseline in HbA1c.||0.365|-0.495|
72473014|NCT01725126|144469813|OTHER|The analysis used an Estimation approach. No hypothesis testing was performed.|Mean Difference (Final Values)|-0.219|||||TWO_SIDED|95.0|-0.91|0.472|||ANCOVA|Terms for treatment and Baseline were included in the model.|Point estimate was calculated as difference in least squares means: Part C-GSK2890457+Metformin minus Part Part C-Placebo+Metformin.|Part C-Placebo+Metformin versus Part C-GSK2890457+Metformin for Day 42 change from Baseline in HbA1c.||0.472|-0.910|
72473015|NCT01725126|144469817|OTHER|The analysis used an Estimation approach. No hypothesis testing was performed.|Ratio|1.046|||||TWO_SIDED|90.0|0.729|1.5008|||Mixed Models Analysis|The PK parameter was log-transformed prior to analysis.|The difference in least squares means and corresponding confidence interval were back-transformed to form ratio of geometric least squares means (Day 42/ Day -1) and confidence interval.|Comparison of Day 42 to Day -1 in GSK2890457+Liraglutide treated participants in the Liraglutide PK Population.||1.5008|0.7290|
72473016|NCT01725126|144469818|OTHER|The analysis used an Estimation approach. No hypothesis testing was performed.|Ratio|1.0334|||||TWO_SIDED|90.0|0.781|1.3673|||Mixed Models Analysis|The PK parameter was log-transformed prior to analysis.|The difference in least squares means and corresponding confidence interval were back-transformed to form ratio of geometric least squares means (Day 42/ Day -1) and confidence interval.|Comparison of Day 42 to Day -1 in GSK2890457+Liraglutide treated participants in the Liraglutide PK Population.||1.3673|0.7810|
72473017|NCT01725126|144469820|OTHER|The analysis used an Estimation approach. No hypothesis testing was performed.|Ratio|0.675|||||TWO_SIDED|90.0|0.585|0.779|||Mixed Models Analysis|The PK parameter was log-transformed prior to analysis.|The difference in least squares means and corresponding confidence interval were back-transformed to form ratio of geometric least squares means (Day 42/ Day 1) and confidence interval.|Comparison of Day 42 to Day 1 in GSK2890457 treated participants in the PK Population.||0.779|0.585|
72623047|NCT02904096|144776394|OTHER|||||||0.001|||||||t-test, 1 sided|||Comparison between Group A: Hand grip strength (Right Hand)-baseline and Group A: Hand grip strength (Right Hand)-change from baseline at Month 24.||||.001
72623048|NCT02904096|144776394|OTHER||||||<|0.001|||||||t-test, 1 sided|||Comparison between Group B: Hand grip strength (Left Hand)-baseline and Group B: Hand grip strength (Left Hand)-change from baseline at Month 24.||||<.001
72623049|NCT02904096|144776394|OTHER|||||||0.002|||||||t-test, 1 sided|||Comparison between Group B: Hand grip strength (Right Hand)-baseline and Group B: Hand grip strength (Right Hand)-change from baseline at Month 24.||||.002
72623050|NCT02904096|144776394|OTHER||||||<|0.001|||||||t-test, 1 sided|||Comparison between Group A: Hand tip pinch strength (Left Hand)-baseline and Group A: Hand tip pinch strength (Left Hand)-change from baseline at Month 24.||||<.001
72473018|NCT01725126|144469821|OTHER|The analysis used an Estimation approach. No hypothesis testing was performed.|Ratio|0.662|||||TWO_SIDED|90.0|0.578|0.757|||Mixed Models Analysis|The PK parameter was log-transformed prior to analysis.|The difference in least squares means and corresponding confidence interval were back-transformed to form ratio of geometric least squares means (Day 42/ Day 1) and confidence interval.|Comparison of Day 42 to Day 1 in GSK2890457 treated participants in the PK Population.||0.757|0.578|
72473019|NCT03296800|144469826|EQUIVALENCE|The acceptance range for bioequivalence is 80.0 - 125.00%.|Point Estimate (%)|118.66|||||TWO_SIDED|90.0|111.12|126.72|||||Point Estimate is the estimated ratio of exponentiated mean difference of log-transformed PK parameter from ANOVA. Confidence interval is obtained from ANOVA with treatment as a fixed effect, and subject as a random effect.|Geometric LS Mean was used as PK parameters||126.72|111.12|
72473020|NCT03296800|144469826|EQUIVALENCE|The acceptance range for bioequivalence is 80.0 - 125.00%.|Point Estimate (%)|119.62|||||TWO_SIDED|90.0|94.39|151.59||||||Geometric LS Mean was used as PK parameters|Point Estimate is the estimated ratio of exponentiated mean difference of log-transformed PK parameter from ANOVA. Confidence interval is obtained from ANOVA with treatment as a fixed effect, and subject as a random effect.|151.59|94.39|
72473021|NCT03296800|144469826|EQUIVALENCE|The acceptance range for bioequivalence is 80.0 - 125.00%.|Point Estimate (%)|106.05|||||TWO_SIDED|90.0|88.81|126.65||||||Geometric LS Mean was used as PK parameters|Point Estimate is the estimated ratio of exponentiated mean difference of log-transformed PK parameter from ANOVA. Confidence interval is obtained from ANOVA with treatment as a fixed effect, and subject as a random effect.|126.65|88.81|
72473022|NCT03296800|144469829|EQUIVALENCE|The acceptance range for bioequivalence is 80.0 - 125.00%.|Point Estimate (%)|140.98|||||TWO_SIDED|90.0|131.39|151.26|||||Point Estimate is the estimated ratio of exponentiated mean difference of log-transformed PK parameter from ANOVA. Confidence interval is obtained from ANOVA with treatment as a fixed effect, and subject as a random effect.|Geometric LS Mean was used as PK parameters||151.26|131.39|
72473023|NCT03296800|144469829|EQUIVALENCE|The acceptance range for bioequivalence is 80.0 - 125.00%.|Point Estimate (%)|86.12|||||TWO_SIDED|90.0|70.24|105.59|||||Point Estimate is the estimated ratio of exponentiated mean difference of log-transformed PK parameter from ANOVA. Confidence interval is obtained from ANOVA with treatment as a fixed effect, and subject as a random effect.|Geometric LS Mean was used as PK parameters||105.59|70.24|
72473024|NCT03296800|144469829|EQUIVALENCE|The acceptance range for bioequivalence is 80.0 - 125.00%.|Point Estimate (%)|97.93|||||TWO_SIDED|90.0|90.26|106.26|||||Point Estimate is the estimated ratio of exponentiated mean difference of log-transformed PK parameter from ANOVA. Confidence interval is obtained from ANOVA with treatment as a fixed effect, and subject as a random effect.|Geometric LS Mean was used as PK parameters||106.26|90.26|
72506791|NCT00121810|144545779|SUPERIORITY_OR_OTHER||Median Difference (Net)|18.7||||0.012||95.0|4.2|33.2||P value comparing the treatment groups calculated using ANCOVA model treatment and baseline calcineurin inhibitor (cyclosporine or tacrolimus) as factors and baseline measurement and time from transplant to randomization as covariates.|ANCOVA|||The primary analysis tested the null hypothesis that mean percent change from baseline to 12 months for Group 1 (mycophenolate mofetil + sirolimus) was equal to that for Group 2 (mycophenolate mofetil + cyclosporine or tacrolimus) based on the intent-to-treat population.||33.2|4.2|0.012
72506792|NCT00121810|144545780|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.3||||0.543||95.0|-9.6|18.2||P value comparing the treatment groups calculated using ANCOVA model treatment and baseline calcineurin inhibitor (cyclosporine or tacrolimus) type as factors and baseline measurement and time from transplant to randomization as covariates.|ANCOVA|||||18.2|-9.6|0.543
72506793|NCT00121810|144545781|SUPERIORITY_OR_OTHER||Median Difference (Net)|-10.8||||0.003||95.0|-17.9|-3.7||P value comparing the two treatment groups is calculated using ANCOVA with treatment and baseline calcineurin inhibitor type (cyclosporine or tacrolimus) as factors, and baseline measurement and time from transplant to randomization as covariates.|ANCOVA|||6 months||-3.7|-17.9|0.003
72506794|NCT00121810|144545781|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-16.0||||0.108||95.0|-35.4|3.5||P value comparing the two treatment groups is calculated using ANCOVA with treatment and baseline calcineurin inhibitor type (cyclosporine or tacrolimus) as factors, and baseline measurement and time from transplant to randomization as covariates.|ANCOVA|||12 months||3.5|-35.4|0.108
72506795|NCT00121810|144545781|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-24.4||||0.039||95.0|-47.7|-1.2||P value comparing the two treatment groups is calculated using ANCOVA with treatment and baseline calcineurin inhibitor type (cyclosporine or tacrolimus) as factors, and baseline measurement and time from transplant to randomization as covariates.|ANCOVA|||24 months||-1.2|-47.7|0.039
72506796|NCT00121810|144545782|SUPERIORITY_OR_OTHER||Mean Difference (Net)|8.7|||<|0.001||95.0|4.1|13.3||P value comparing the two treatment groups is calculated using ANCOVA with treatment and baseline calcineurin inhibitor type (cyclosporine or tacrolimus) as factors, and baseline measurement and time from transplant to randomization as covariates.|ANCOVA|||6 months||13.3|4.1|<0.001
72506797|NCT00121810|144545782|SUPERIORITY_OR_OTHER||Mean Difference (Net)|6.9||||0.029||95.0|0.7|13.1||P value comparing the two treatment groups is calculated using ANCOVA with treatment and baseline calcineurin inhibitor type (cyclosporine or tacrolimus) as factors, and baseline measurement and time from transplant to randomization as covariates.|ANCOVA|||12 months||13.1|0.7|0.029
72506798|NCT00121810|144545782|SUPERIORITY_OR_OTHER||Mean Difference (Net)|8.8||||0.015||95.0|1.7|15.9||P value comparing the two treatment groups is calculated using ANCOVA with treatment and baseline calcineurin inhibitor type (cyclosporine or tacrolimus) as factors, and baseline measurement and time from transplant to randomization as covariates.|ANCOVA|||24 months||15.9|1.7|0.015
72506799|NCT00121810|144545783|SUPERIORITY_OR_OTHER||Mean Difference (Net)|8.5|||<|0.001||95.0|4.2|12.9||P value comparing the two treatment groups is calculated using ANCOVA with treatment and baseline calcineurin inhibitor type (cyclosporine or tacrolimus) as factors, and baseline measurement and time from transplant to randomization as covariates.|ANCOVA|||6 months||12.9|4.2|<0.001
72623051|NCT02904096|144776394|OTHER||||||<|0.001|||||||t-test, 1 sided|||Comparison between Group A: Hand tip pinch strength (Right Hand)-baseline and Group A: Hand tip pinch strength (Right Hand)-change from baseline at Month 24.||||<.001
72397951|NCT01042236|144301893|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.78|STANDARD_ERROR_OF_MEAN|0.94||0.4167|TWO_SIDED|95.0|-2.71|1.15||A treatment by period interaction term (fixed effect) was included if significant at 10% significance level.|ANCOVA|||Change from baseline (prior to Period 1) at the end of the treatment period was analyzed using an analysis of covariance (ANCOVA) model, with fixed effect terms for sequence, period and treatment, using baseline (prior to Period 1) as a covariate, and participant within sequence as a random effect.||1.15|-2.71|0.4167
72397952|NCT01042236|144301894|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.12||0.9403|TWO_SIDED|95.0|-0.24|0.26||A treatment by period interaction term (fixed effect) was included if significant at 10% significance level.|ANCOVA|||Change from baseline (prior to Period 1) at the end of the treatment period was analyzed using an analysis of covariance (ANCOVA) model, with fixed effect terms for sequence, period and treatment, using baseline (prior to Period 1) as a covariate, and participant within sequence as a random effect.||0.26|-0.24|0.9403
72397953|NCT01042236|144301894|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.17|STANDARD_ERROR_OF_MEAN|0.12||0.1881|TWO_SIDED|95.0|-0.42|0.09||A treatment by period interaction term (fixed effect) was included if significant at 10% significance level.|ANCOVA|||Change from baseline (prior to Period 1) at the end of the treatment period was analyzed using an analysis of covariance (ANCOVA) model, with fixed effect terms for sequence, period and treatment, using baseline (prior to Period 1) as a covariate, and participant within sequence as a random effect.||0.09|-0.42|0.1881
72397954|NCT01042236|144301895|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.12||0.8602|TWO_SIDED|95.0|-0.26|0.22||A treatment by period interaction term (fixed effect) was included if significant at 10% significance level.|ANCOVA|||Change from baseline (prior to Period 1) at the end of the treatment period was analyzed using an analysis of covariance (ANCOVA) model, with fixed effect terms for sequence, period and treatment, using baseline (prior to Period 1) as a covariate, and participant within sequence as a random effect.||0.22|-0.26|0.8602
72473025|NCT03031496|144469878|EQUIVALENCE|Bioequivalence of hydrochlorothiazide and amiloride hydrochloride was determined.|Least square mean ratio|91.52|||||TWO_SIDED|90.0|87.77|95.43|||||Comparison of AUC (0-t) of hydrochlorothiazide for test and reference product has been presented.|||95.43|87.77|
72397955|NCT01042236|144301895|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.19|STANDARD_ERROR_OF_MEAN|0.12||0.1271|TWO_SIDED|95.0|-0.43|0.06||A treatment by period interaction term (fixed effect) was included if significant at 10% significance level.|ANCOVA|||Change from baseline (prior to Period 1) at the end of the treatment period was analyzed using an analysis of covariance (ANCOVA) model, with fixed effect terms for sequence, period and treatment, using baseline (prior to Period 1) as a covariate, and participant within sequence as a random effect.||0.06|-0.43|0.1271
72473026|NCT03031496|144469878|EQUIVALENCE|Bioequivalence of hydrochlorothiazide and amiloride hydrochloride was determined.|Least square mean ratio|102.42|||||TWO_SIDED|90.0|98.12|106.91|||||Comparison of AUC (0-t) of amiloride for test and reference product has been presented.|||106.91|98.12|
72473027|NCT03031496|144469879|EQUIVALENCE|Bioequivalence of hydrochlorothiazide and amiloride hydrochloride was determined.|Least square mean ratio|82.86|||||TWO_SIDED|90.0|77.37|88.74|||||Comparison of Cmax of hydrochlorothiazide for test and reference product has been presented.|||88.74|77.37|
72473028|NCT03031496|144469879|EQUIVALENCE|Bioequivalence of hydrochlorothiazide and amiloride hydrochloride was determined.|Least square mean ratio|103.92|||||TWO_SIDED|90.0|97.42|110.86|||||Comparison of Cmax of amiloride for test and reference product has been presented.|||110.86|97.42|
72473029|NCT03031496|144469880|EQUIVALENCE|Bioequivalence of hydrochlorothiazide and amiloride hydrochloride was determined.|Least square mean ratio|92.37|||||TWO_SIDED|90.0|88.75|96.12|||||Comparison of Tmax of hydrochlorothiazide for test and reference product has been presented.|||96.12|88.75|
72397956|NCT00227903|144301903|SUPERIORITY_OR_OTHER_LEGACY|||||||0.88||95.0||||Not corrected for multiple comparison|Mixed Models Analysis|2 degrees of freedom||We estimated that 110 people with 10% attrition would provide 80% power||||0.88
72397957|NCT00227903|144301904|SUPERIORITY_OR_OTHER_LEGACY|||||||0.08||95.0|||||Fisher Exact|||||||0.08
72397958|NCT00227903|144301905|SUPERIORITY_OR_OTHER_LEGACY|||||||0.88||95.0||||Not corrected for multiple comparison.|Mixed Models Analysis|2 degrees of freedom||We estimated that 110 people with 10% attrition would provide 80% power.||||0.88
72397959|NCT00227903|144301906|SUPERIORITY_OR_OTHER_LEGACY|||||||0.41||95.0|||||Fisher Exact|||||||0.41
72397960|NCT00227903|144301907|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.77||||0.79|TWO_SIDED|95.0|0.36|1.67|||Regression, Logistic|||||1.67|0.36|0.79
72473030|NCT03031496|144469880|OTHER||Least square mean ratio|101.47|||||TWO_SIDED|90.0|97.84|105.23|||||Comparison of Tmax of amiloride for test and reference product has been presented.|||105.23|97.84|
72473031|NCT01254552|144469894|OTHER||rate|0.071|||||TWO_SIDED|95.0|0.043|0.1||||||||0.100|0.043|
72506800|NCT00121810|144545783|SUPERIORITY_OR_OTHER||Mean Difference (Net)|5.8||||0.059||95.0|-0.2|11.9||P value comparing the two treatment groups is calculated using ANCOVA with treatment and baseline calcineurin inhibitor type (cyclosporine or tacrolimus) as factors, and baseline measurement and time from transplant to randomization as covariates.|ANCOVA|||12 months||11.9|-0.2|0.059
72623052|NCT02904096|144776394|OTHER||||||<|0.001|||||||t-test, 1 sided|||Comparison between Group B: Hand tip pinch strength (Left Hand)-baseline and Group B: Hand tip pinch strength (Left Hand)-change from baseline at Month 24.||||<.001
72397961|NCT00227903|144301908|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.05||||0.79|TWO_SIDED|95.0|0.42|2.62|||Regression, Logistic|||||2.62|0.42|0.79
72397962|NCT00227903|144301909|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.96||||0.88|TWO_SIDED|95.0|0.34|2.72|||Regression, Logistic|||||2.72|0.34|0.88
72397963|NCT00227903|144301910|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.21||||0.88|TWO_SIDED|95.0|0.57|2.57|||Regression, Logistic|||||2.57|0.57|0.88
72397964|NCT00227903|144301911|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.77||||0.5|TWO_SIDED|95.0|0.32|1.84|||Regression, Logistic|||||1.84|0.32|0.50
72397965|NCT00227903|144301912|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1||95.0|||||Mixed Models Analysis|||||||0.10
72397966|NCT00227903|144301913|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1||95.0|||||Mixed Models Analysis|||||||0.10
72397967|NCT00227903|144301914|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1||95.0|||||Mixed Models Analysis|||||||0.10
72397968|NCT00227903|144301915|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1||95.0|||||Mixed Models Analysis|||||||0.10
72397969|NCT00227903|144301916|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.76||||0.5|TWO_SIDED|95.0|0.27|2.11|||Regression, Logistic|||||2.11|0.27|0.50
72397970|NCT00227903|144301917|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.18||||0.07|TWO_SIDED|95.0|0.44|3.14|||Regression, Logistic|||||3.14|0.44|0.07
72397971|NCT00227903|144301918|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.46||||0.07|TWO_SIDED|95.0|0.47|4.52|||Regression, Logistic|||||4.52|0.47|0.07
72397972|NCT00227903|144301919|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.28||||0.07|TWO_SIDED|95.0|0.08|1.02|||Regression, Logistic|||||1.02|0.08|0.07
72397973|NCT00227903|144301920|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.62||||0.07|TWO_SIDED|95.0|0.1|3.9|||Regression, Logistic|||||3.90|0.10|0.07
72397974|NCT00227903|144301921|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.15||||0.91|TWO_SIDED|95.0|0.32|4.2|||Regression, Logistic|||||4.20|0.32|0.91
72473032|NCT02579135|144469897|SUPERIORITY|Before the onset of the study, we conducted a power calculation to determine the appropriate sample size. We designed the study to have 80% power at a .05 significance level to detect differences in primary outcomes, assuming an effect size of 0.5 and a correlation of 0.4 between assessments. Final enrollment (n= 222) exceeded our target sample size (n= 150).|beta|0.05|STANDARD_ERROR_OF_MEAN|0.05||0.32|TWO_SIDED||||||Regression, Linear|||Third, to assess the effectiveness of the HEART intervention from pretest to immediate posttest, we used linear regression analyses to compute adjusted means and mean differences between intervention and control groups. We included an indicator for school to adjust for clustering by school. For each outcome, the corresponding pretest measure was included as a covariate.||||.32
72473033|NCT02579135|144469898|SUPERIORITY|Before the onset of the study, we conducted a power calculation to determine the appropriate sample size. We designed the study to have 80% power at a .05 significance level to detect differences in primary outcomes, assuming an effect size of 0.5 and a correlation of 0.4 between assessments. Final enrollment (n= 222) exceeded our target sample size (n= 150).|beta|8.31|STANDARD_ERROR_OF_MEAN|2.71|<|0.001|TWO_SIDED||||||Regression, Linear|||We used linear regression analyses to compute adjusted means and mean differences between intervention and control groups. We included an indicator for school to adjust for clustering by school. For each outcome, the corresponding pretest measure was included as a covariate.||||<.001
72473034|NCT01146600|144469899|SUPERIORITY_OR_OTHER|||||||0.47||95.0|||||ANOVA|ANOVA, comparing baseline, clarithromycin, and placebo||||||0.47
72473035|NCT01146600|144469900|SUPERIORITY_OR_OTHER|||||||0.63||95.0|||||ANOVA|ANOVA comparing baseline, clarithromycin, and placebo||||||0.63
72473036|NCT01146600|144469901|SUPERIORITY_OR_OTHER|||||||0.64||95.0|||||ANOVA|ANOVA comparing baseline, clarithromycin, and placebo||||||0.64
72473037|NCT01146600|144469902|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||ANOVA|ANOVA comparing baseline, clarithromycin, and placebo||||||0.002
72473038|NCT01146600|144469903|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||ANOVA|ANOVA comparing baseline, clarithromycin, and placebo||||||0.002
72473039|NCT01146600|144469904|SUPERIORITY_OR_OTHER|||||||0.01||95.0|||||ANOVA|ANOVA comparing baseline, clarithromycin, and placebo||||||0.01
72473040|NCT01146600|144469905|SUPERIORITY_OR_OTHER|||||||0.76||95.0|||||ANOVA|ANOVA comparing baseline, clarithromycin, and placebo||||||0.76
72473041|NCT00588692|144469948|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||For 25-49% Ejection Fraction Subgroup||||<0.05
72473042|NCT00588692|144469948|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||35-49% Ejection Fraction Subgroup||||<0.05
72473043|NCT00588692|144469950|SUPERIORITY_OR_OTHER|||||||0.06|||||||ANOVA|||||||0.06
72506801|NCT00121810|144545783|SUPERIORITY_OR_OTHER||Mean Difference (Net)|7.5||||0.036||95.0|0.5|14.5||P value comparing the two treatment groups is calculated using ANCOVA with treatment and baseline calcineurin inhibitor type (cyclosporine or tacrolimus) as factors, and baseline measurement and time from transplant to randomization as covariates.|ANCOVA|||24 months||14.5|0.5|0.036
72623053|NCT02904096|144776394|OTHER||||||<|0.001|||||||t-test, 1 sided|||Comparison between Group B: Hand tip pinch strength (Right Hand)-baseline and Group B: Hand tip pinch strength (Right Hand)-change from baseline at Month 24.||||<.001
72473044|NCT00588692|144469951|SUPERIORITY_OR_OTHER|||||||0.5|||||||ANOVA|||||||0.5
72473045|NCT00588692|144469951|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||Within group change compared to baseline||||<0.05
72473046|NCT00588692|144469951|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||Within group change compared to baseline||||<0.05
72397975|NCT00227903|144301922|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.33||||0.91|TWO_SIDED|95.0|0.35|5.07|||Regression, Logistic|||||5.07|0.35|0.91
72473047|NCT00588692|144469952|SUPERIORITY_OR_OTHER|||||||0.26|||||||ANOVA|||||||0.26
72397976|NCT00227903|144301923|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.85||||0.91|TWO_SIDED|95.0|0.14|5.23|||Regression, Logistic|||||5.23|0.14|0.91
72397977|NCT00227903|144301924|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.23||||0.91|TWO_SIDED|95.0|0.21|7.12|||Regression, Logistic|||||7.12|0.21|0.91
72397978|NCT00227903|144301925|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.28||||0.04|TWO_SIDED|95.0|0.46|3.55|||Regression, Logistic|||||3.55|0.46|.04
72397979|NCT00227903|144301926|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.21||||0.04|TWO_SIDED|95.0|0.35|4.17|||Regression, Logistic|||||4.17|0.35|0.04
72397980|NCT00227903|144301927|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.25||||0.04|TWO_SIDED|95.0|0.04|1.63|||Regression, Logistic|||||1.63|0.04|0.04
72397981|NCT00227903|144301928|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.4||||0.04|TWO_SIDED|95.0|0.04|3.74|||Regression, Logistic|||||3.74|0.04|0.04
72397982|NCT00227903|144301929|SUPERIORITY_OR_OTHER_LEGACY|||||||0.01||95.0|||||Cochran-Mantel-Haenszel|||||||0.01
72397983|NCT00227903|144301930|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05||95.0|||||Chi-squared|||||||>0.05
72397984|NCT02451839|144301938|SUPERIORITY||||||<|0.001|||||||paired t-test|||||||< 0.001
72397985|NCT02451839|144301939|SUPERIORITY||||||<|0.001|||||||paired t-test|||||||<0.001
72397986|NCT02451839|144301940|SUPERIORITY||||||<|0.001|||||||paired t-test|||||||<0.001
72397987|NCT02451839|144301941|SUPERIORITY||||||<|0.001|||||||paired t-test|||||||<0.001
72397988|NCT02451839|144301942|SUPERIORITY||||||<|0.001|||||||paired t-test|||||||<0.001
72473048|NCT00588692|144469952|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||Within group change compared to baseline||||<0.05
72473049|NCT00588692|144469952|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||Within group change compared to baseline||||<0.05
72506802|NCT02260193|144545796|SUPERIORITY||Least Squares Mean Differences|0.29|||||TWO_SIDED|95.0|-0.25|0.82||||||||0.82|-0.25|
72623054|NCT02904096|144776394|OTHER|||||||0.001|||||||t-test, 1 sided|||Comparison between Group A: Hand key pinch strength (Left Hand)-baseline and Group A: Hand key pinch strength (Left Hand)-change from baseline at Month 24.||||.001
72397989|NCT02451839|144301943|SUPERIORITY||||||<|0.001|||||||paired t-test|||||||<0.001
72397990|NCT02451839|144301944|SUPERIORITY|||||||0.015|||||||paired t-test|||||||0.015
72473050|NCT00588692|144469953|SUPERIORITY_OR_OTHER|||||||0.4|||||||ANOVA|||||||0.4
72473051|NCT00588692|144469954|SUPERIORITY_OR_OTHER|||||||0.9|||||||ANOVA|||||||0.9
72506803|NCT02260193|144545796|SUPERIORITY||Least Squares Mean Differences|0.36|||||TWO_SIDED|95.0|-0.19|0.9||||||||0.90|-0.19|
72506804|NCT02260193|144545796|SUPERIORITY||Least Squares Mean Differences|0.07|||||TWO_SIDED|95.0|-0.48|0.61||||||||0.61|-0.48|
72506805|NCT02260193|144545797|SUPERIORITY||Least Squares Mean Differences|0.04|||||TWO_SIDED|95.0|-0.54|0.61||||||||0.61|-0.54|
72506806|NCT02260193|144545797|SUPERIORITY||Least Squares Mean Differences|0.1|||||TWO_SIDED|95.0|-0.49|0.7||||||||0.70|-0.49|
72506807|NCT02260193|144545797|SUPERIORITY||Least squares mean difference|0.07|||||TWO_SIDED|95.0|-0.53|0.66||||||||0.66|-0.53|
72506808|NCT02260193|144545798|SUPERIORITY||Least squares mean difference|-0.34|||||TWO_SIDED|95.0|-0.71|0.04||||||||0.04|-0.71|
72506809|NCT02260193|144545798|SUPERIORITY||Least squares mean difference|-0.11|||||TWO_SIDED|95.0|-0.5|0.29||||||||0.29|-0.50|
72473052|NCT00588692|144469954|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||Within group change compared to baseline||||<0.05
72473053|NCT00588692|144469954|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||Within group change compared to baseline||||<0.05
72473054|NCT00588692|144469955|SUPERIORITY_OR_OTHER|||||||0.9|||||||ANOVA|||||||0.9
72473055|NCT00588692|144469956|SUPERIORITY_OR_OTHER|||||||0.9|||||||ANOVA|||||||0.9
72473056|NCT00588692|144469957|SUPERIORITY_OR_OTHER|||||||0.3|||||||ANOVA|||||||0.3
72506810|NCT02260193|144545798|SUPERIORITY||Least squares mean difference|0.23|||||TWO_SIDED|95.0|-0.16|0.62||||||||0.62|-0.16|
72506811|NCT02389946|144545829|NON_INFERIORITY|Non-inferiority of the 12-month TLF rate for the Orsiro stent vs. the Xience stent was assessed as the primary endpoint. The null hypothesis H0 was that the Orsiro stent would have a primary endpoint (12-month TLF) rate equal to or exceeding that of the Xience group by the non-inferiority margin or more. The alternative hypothesis HA was that the Orsiro stent would have a 12-month TLF rate less than the Xience group rate plus the non-inferiority margin of 3.85%.|Posterior Probability of non-inferioriry|100.0|||||TWO_SIDED|||||||||Bayesian calculation using a hierarchical model to incorporate data from previous BIOFLOW-II and BIOFLOW-IV trials.||||
72506812|NCT02389946|144545830|OTHER|||||||0.415|||||||Fisher Exact|||||||0.415
72623055|NCT02904096|144776394|OTHER||||||<|0.001|||||||t-test, 1 sided|||Comparison between Group A: Hand key pinch strength (Right Hand)-baseline and Group A: Hand key pinch strength (Right Hand)-change from baseline at Month 24.||||<.001
72397991|NCT02451839|144301945|SUPERIORITY||||||<|0.001|||||||paired t-test|||||||<0.001
72397992|NCT02451839|144301946|SUPERIORITY|||||||0.006|||||||paired t-test|||||||0.006
72397993|NCT02451839|144301947|SUPERIORITY||||||<|0.001|||||||paired t-test|||||||<0.001
72397994|NCT02451839|144301948|SUPERIORITY||||||<|0.001|||||||paired t-test|||||||<0.001
72397995|NCT02451839|144301949|SUPERIORITY|||||||0.006|||||||paired t-test|||||||0.006
72397996|NCT02451839|144301950|SUPERIORITY||||||<|0.001|||||||paired t-test|||||||<0.001
72397997|NCT02451839|144301951|SUPERIORITY||||||<|0.001|||||||paired t-test|||||||<0.001
72397998|NCT02451839|144301952|SUPERIORITY||||||<|0.001|||||||paired t-test|||||||<0.001
72397999|NCT02451839|144301953|SUPERIORITY||||||<|0.001|||||||paired t-test|||||||<0.001
72473057|NCT00588692|144469958|SUPERIORITY_OR_OTHER|||||||0.9|||||||ANOVA|||||||0.9
72473058|NCT00588692|144469958|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||Within group change compared to baseline||||<0.05
72473059|NCT00588692|144469958|SUPERIORITY_OR_OTHER|||||||0.24|||||||t-test, 2 sided|||||||0.24
72473060|NCT00588692|144469959|SUPERIORITY_OR_OTHER|||||||0.6|||||||ANOVA|||||||0.6
72473061|NCT00588692|144469960|SUPERIORITY_OR_OTHER|||||||0.9|||||||ANOVA|||||||0.9
72473062|NCT00588692|144469960|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||Within group change compared to baseline||||<0.05
72506813|NCT00798967|144545839|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002||95.0||||Cochran-Mantel-Haenszel (CMH) test adjusted for the randomization stratification variable (\<= 6 or \> 6 L/week of PN at baseline)|Cochran-Mantel-Haenszel|||||||0.002
72506814|NCT00798967|144545840|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||ANCOVA|||Last Dosing Visit||||< 0.001
72506815|NCT01377467|144545841|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.059|STANDARD_ERROR_OF_MEAN|0.967|<|0.001|TWO_SIDED|95.0|3.137|6.98|||ANCOVA||Percentage change in BMD was compared between the two treatment groups while controlling for the effects of baseline BMD.|We calculated that a sample size of 43 patients per group would provide a statistical power of 86% to detect a 4% difference in the percentage change of areal BMD at the total lumbar spine at 12 months, using a two-sided t-test with an α-level of 0.05 and assuming a mean ± SD change of 4 ± 6% in the denosumab group and 0 ± 6% in the control group. To account for a dropout rate of 5%, it was planned to randomize a total of 90 patients.||6.980|3.137|<0.001
72506816|NCT01377467|144545842|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.895|STANDARD_ERROR_OF_MEAN|0.887||0.035|TWO_SIDED|95.0|0.132|3.659|||ANCOVA||Percentage change in BMD was compared between the two treatment groups while controlling for the effects of baseline BMD.|||3.659|0.132|0.035
72506817|NCT01377467|144545843|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.059|STANDARD_ERROR_OF_MEAN|1.201||0.38|TWO_SIDED|95.0|-1.329|3.447|||ANCOVA||Percentage change in BMD was compared between the two treatment groups while controlling for the effects of baseline BMD.|||3.447|-1.329|0.380
72506818|NCT01377467|144545844|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.567|STANDARD_ERROR_OF_MEAN|0.806|<|0.001|TWO_SIDED|95.0|2.975|6.178|||ANCOVA||Percentage change in BMD was compared between the two treatment groups while controlling for the effects of baseline BMD.|||6.178|2.975|<0.001
72506819|NCT01377467|144545845|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.756|STANDARD_ERROR_OF_MEAN|0.662||0.009|TWO_SIDED|95.0|0.44|3.072|||ANCOVA||Percentage change in BMD was compared between the two treatment groups while controlling for the effects of baseline BMD.|||3.072|0.440|0.009
72506820|NCT01377467|144545846|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.035|STANDARD_ERROR_OF_MEAN|1.085||0.064|TWO_SIDED|95.0|-0.122|4.193|||ANCOVA||Percentage change in BMD was compared between the two treatment groups while controlling for the effects of baseline BMD.|||4.193|-0.122|0.064
72623056|NCT02904096|144776394|OTHER||||||<|0.001|||||||t-test, 1 sided|||Comparison between Group B: Hand key pinch strength (Left Hand)-baseline and Group B: Hand key pinch strength (Left Hand)-change from baseline at Month 24.||||<.001
72398000|NCT01291173|144301955|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.014||||0.8825|TWO_SIDED|95.0|-0.203|0.175|||Mixed Models Analysis|||||0.175|-0.203|0.8825
72473063|NCT00588692|144469960|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||Within group change compared to baseline||||<0.05
72473064|NCT00588692|144469961|SUPERIORITY_OR_OTHER|||||||0.11|||||||ANOVA|||||||0.11
72473065|NCT00588692|144469961|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||Within group change compared to baseline||||<0.05
72473066|NCT00588692|144469961|SUPERIORITY_OR_OTHER|||||||0.16|||||||t-test, 2 sided|||||||0.16
72473067|NCT00588692|144469962|SUPERIORITY_OR_OTHER|||||||0.4|||||||ANOVA|||||||0.4
72473068|NCT00588692|144469962|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||Within group change compared to baseline||||<0.05
72473069|NCT00588692|144469962|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||Within group change compared to baseline||||<0.05
72473070|NCT00588692|144469963|SUPERIORITY_OR_OTHER|||||||0.9|||||||ANOVA|||||||0.9
72473071|NCT00588692|144469963|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||Within group change compared to baseline||||<0.05
72473072|NCT00588692|144469963|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||Within group change compared to baseline||||<0.05
72398001|NCT01291173|144301955|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.258||||0.0077|TWO_SIDED|95.0|-0.446|-0.069|||Mixed Models Analysis|||||-0.069|-0.446|0.0077
72473073|NCT03617835|144469985|OTHER|Relative bioavailability|Ratio of the geometric means (T1/R) [%]|93.67|||||TWO_SIDED|90.0|78.48|111.8|||||The geometric means are adjusted by treatment. The geometric Coefficient of (within matched pair) Variation (gCV) \[%\] = 26.0.|Exploratory trial, no formal hypotheses were tested. Analysis of Variance (ANOVA) model on the logarithmic scale was used which included effects accounting for sources of variation: 'treatment' (fixed effect), 'matched pair' (random effect). For each matched pair in the study (participant in test treatment group matched to participant in reference treatment group), a pair number was assigned for analysis purpose.||111.80|78.48|
72473074|NCT03617835|144469985|OTHER|Relative bioavailability|Ratio of the geometric means (T2/R) [%]|139.95|||||TWO_SIDED|90.0|117.26|167.03|||||The geometric means are adjusted by treatment. The geometric Coefficient of (within matched pair) Variation (gCV) \[%\] = 26.0.|Exploratory trial, no formal hypotheses were tested. Analysis of Variance (ANOVA) model on the logarithmic scale was used which included effects accounting for sources of variation: 'treatment' (fixed effect), 'matched pair' (random effect). For each matched pair in the study (participant in test treatment group matched to participant in reference treatment group), a pair number was assigned for analysis purpose.||167.03|117.26|
72473075|NCT03617835|144469986|OTHER|Relative bioavailability|Ratio of the geometric means (T3/R) [%]|121.84|||||TWO_SIDED|90.0|102.08|145.41|||||The geometric means are adjusted by treatment. The geometric Coefficient of (within matched pair) Variation (gCV) \[%\] = 26.0.|Exploratory trial, no formal hypotheses were tested. Analysis of Variance (ANOVA) model on the logarithmic scale was used which included effects accounting for sources of variation: 'treatment' (fixed effect), 'matched pair' (random effect). For each matched pair in the study (participant in test treatment group matched to participant in reference treatment group), a pair number was assigned for analysis purpose.||145.41|102.08|
72473076|NCT03617835|144469987|OTHER|Relative bioavailability|Ratio of the geometric means (T1/R) [%]|99.17|||||TWO_SIDED|90.0|83.77|117.39|||||The geometric means are adjusted by treatment. The geometric Coefficient of (within matched pair) Variation (gCV) \[%\] = 24.8.|Exploratory trial, no formal hypotheses were tested. Analysis of Variance (ANOVA) model on the logarithmic scale was used which included effects accounting for sources of variation: 'treatment' (fixed effect), 'matched pair' (random effect). For each matched pair in the study (participant in test treatment group matched to participant in reference treatment group), a pair number was assigned for analysis purpose.||117.39|83.77|
72473077|NCT03617835|144469987|OTHER|Relative bioavailability|Ratio of the geometric means (T2/R) [%]|156.2|||||TWO_SIDED|90.0|131.95|184.9|||||The geometric means are adjusted by treatment. The geometric Coefficient of (within matched pair) Variation (gCV) \[%\] = 24.8.|Exploratory trial, no formal hypotheses were tested. Analysis of Variance (ANOVA) model on the logarithmic scale was used which included effects accounting for sources of variation: 'treatment' (fixed effect), 'matched pair' (random effect). For each matched pair in the study (participant in test treatment group matched to participant in reference treatment group), a pair number was assigned for analysis purpose.||184.90|131.95|
72473078|NCT03617835|144469988|OTHER|Relative bioavailability|Ratio of the geometric means (T3/R) [%]|138.34|||||TWO_SIDED|90.0|116.87|163.77|||||The geometric means are adjusted by treatment. The geometric Coefficient of (within matched pair) Variation (gCV) \[%\] = 24.8.|Exploratory trial, no formal hypotheses were tested. Analysis of Variance (ANOVA) model on the logarithmic scale was used which included effects accounting for sources of variation: 'treatment' (fixed effect), 'matched pair' (random effect). For each matched pair in the study (participant in test treatment group matched to participant in reference treatment group), a pair number was assigned for analysis purpose.||163.77|116.87|
72473079|NCT03617835|144469989|OTHER|Relative bioavailability|Ratio of the geometric means (T1/R) [%]|93.58|||||TWO_SIDED|90.0|78.11|112.11|||||The geometric means are adjusted by treatment. The geometric Coefficient of (within matched pair) Variation (gCV) \[%\] = 26.6.|Exploratory trial, no formal hypotheses were tested. Analysis of Variance (ANOVA) model on the logarithmic scale was used which included effects accounting for sources of variation: 'treatment' (fixed effect), 'matched pair' (random effect). For each matched pair in the study (participant in test treatment group matched to participant in reference treatment group), a pair number was assigned for analysis purpose.||112.11|78.11|
72623057|NCT02904096|144776394|OTHER||||||<|0.001|||||||t-test, 1 sided|||Comparison between Group B: Hand key pinch strength (Right Hand)-baseline and Group B: Hand key pinch strength (Right Hand)-change from baseline at Month 24.||||<.001
72398002|NCT01291173|144301955|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.345||||0.0004|TWO_SIDED|95.0|-0.534|-0.155|||Mixed Models Analysis|||||-0.155|-0.534|0.0004
72398003|NCT01291173|144301956|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4676|TWO_SIDED|95.0|||||Cochran-Mantel-Haenszel|||||||0.4676
72398004|NCT01291173|144301956|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0198|TWO_SIDED|95.0|||||Cochran-Mantel-Haenszel|||||||0.0198
72398005|NCT01291173|144301956|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0031|TWO_SIDED|95.0|||||Cochran-Mantel-Haenszel|||||||0.0031
72398006|NCT01291173|144301957|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3341|TWO_SIDED|95.0|||||Cochran-Mantel-Haenszel|||||||0.3341
72398007|NCT01291173|144301957|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0063|TWO_SIDED|95.0|||||Cochran-Mantel-Haenszel|||||||0.0063
72473080|NCT03617835|144469989|OTHER|Relative bioavailability|Ratio of the geometric means (T2/R) [%]|139.73|||||TWO_SIDED|90.0|116.64|167.4|||||The geometric means are adjusted by treatment. The geometric Coefficient of (within matched pair) Variation (gCV) \[%\] = 26.6.|Exploratory trial, no formal hypotheses were tested. Analysis of Variance (ANOVA) model on the logarithmic scale was used which included effects accounting for sources of variation: 'treatment' (fixed effect), 'matched pair' (random effect). For each matched pair in the study (participant in test treatment group matched to participant in reference treatment group), a pair number was assigned for analysis purpose.||167.40|116.64|
72473081|NCT03617835|144469990|OTHER|Relative bioavailability|Ratio of the geometric means (T3/R) [%]|121.34|||||TWO_SIDED|90.0|101.28|145.37|||||The geometric means are adjusted by treatment. The geometric Coefficient of (within matched pair) Variation (gCV) \[%\] = 26.6.|Exploratory trial, no formal hypotheses were tested. Analysis of Variance (ANOVA) model on the logarithmic scale was used which included effects accounting for sources of variation: 'treatment' (fixed effect), 'matched pair' (random effect). For each matched pair in the study (participant in test treatment group matched to participant in reference treatment group), a pair number was assigned for analysis purpose.||145.37|101.28|
72473082|NCT01077518|144469993|SUPERIORITY||Stratified Cox propor.hazards regression|0.82||||0.139|TWO_SIDED|95.0|0.62|1.07|||Stratified Log-Rank|||||1.07|0.62|0.1390
72473083|NCT01077518|144469994|OTHER||Stratified Cox propor.hazards regression|0.76||||0.1076|TWO_SIDED|95.0|0.55|1.06|||Stratified Log-Rank|||||1.06|0.55|0.1076
72473084|NCT01077518|144469995|OTHER|||||||0.8003|||||||Cochran-Mantel-Haenszel|adjusted for stratum||for All participants||||0.8003
72473085|NCT01077518|144469996|OTHER|||||||0.613|||||||Cochran-Mantel-Haenszel|adjusted for stratum||for Follicular Lymphoma (FL) participants||||0.6130
72473086|NCT01077518|144469997|OTHER||Hazard Ratio (HR)|0.87||||0.4046|TWO_SIDED|95.0|0.62|1.21|||Stratified Log Rank|||for All patients||1.21|0.62|0.4046
72473087|NCT01077518|144469998|SUPERIORITY||Hazard Ratio (HR)|0.83||||0.3768|TWO_SIDED|95.0|0.55|1.25|||Stratified Log Rank|||for FL participants||1.25|0.55|0.3768
72473088|NCT01495598|144470022|OTHER|Other = Kaplan Meier||||||0.43|||||||Log Rank|||||||0.43
72473089|NCT01495598|144470032|OTHER|\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.||||||0.19||||||The reported p-value is representative of the changes in levels of IFNƴ among all participants. Two tailed Wilcoxon signed rank test without adjustment for multiple comparisons.|Wilcoxon signed rank test|||||||0.19
72473090|NCT01495598|144470032|OTHER|P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.||||||0.72||||||The reported p-value is representative of the changes in levels of IFNƴ among all participants. Two tailed Wilcoxon signed rank test without adjustment for multiple comparisons.|Wilcoxon signed rank test|||||||0.72
72506821|NCT01377467|144545847|SUPERIORITY_OR_OTHER||between-subjects effect|10.466|||<|0.001|TWO_SIDED||||||repeated measures GLM||Within-subjects effect: p=0.007. Time\*treatment interaction: p=0.002. The a priori threshold for statistical significance is \<0.05.|||||<0.001
72506822|NCT01377467|144545848|SUPERIORITY_OR_OTHER||between-subjects effect|275622.016|||<|0.001|TWO_SIDED||||||repeated measures GLM||Within-subjects effect: p\<0.001. Time\*treatment interaction: p=0.012. The a priori threshold for statistical significance is \<0.05.|||||<0.001
72398008|NCT01291173|144301957|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0022|TWO_SIDED|95.0|||||Cochran-Mantel-Haenszel|||||||0.0022
72473091|NCT01495598|144470032|OTHER|P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.||||||0.03||||||The reported p-value is representative of the changes in levels of IFNƴ among all participants. Two tailed Wilcoxon signed rank test without adjustment for multiple comparisons.|Wilcoxon signed rank test|||||||0.03
72473092|NCT01495598|144470032|OTHER|P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.|||||<|0.0001||||||The reported p-value is representative of the changes in levels of IL4 among all participants. Two tailed Wilcoxon signed rank test without adjustment for multiple comparisons.|Wilcoxon signed rank test|||||||<0.0001
72473093|NCT01495598|144470032|OTHER|P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.|||||<|0.0001||||||The reported p-value is representative of the changes in levels of IL4 among all participants. Two tailed Wilcoxon signed rank test without adjustment for multiple comparisons.|Wilcoxon signed rank test|||||||<0.0001
72506823|NCT01377467|144545849|SUPERIORITY_OR_OTHER||between-subjects effect|0.717||||0.014|TWO_SIDED||||||repeated measures GLM||Within-subjects effect: p\<0.001. Time\*treatment interaction: p\<0.001. The a priori threshold for statistical significance is \<0.05.|||||0.014
72398009|NCT01291173|144301958|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0937|TWO_SIDED|95.0|||||Cochran-Mantel-Haenszel|||||||0.0937
72398010|NCT01291173|144301958|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0127|TWO_SIDED|95.0|||||Cochran-Mantel-Haenszel|||||||0.0127
72398011|NCT01291173|144301958|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0009|TWO_SIDED|95.0|||||Cochran-Mantel-Haenszel|||||||0.0009
72473094|NCT01495598|144470032|OTHER|P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.|||||<|0.0001||||||The reported p-value is representative of the changes in levels of IL4 among all participants. Two tailed Wilcoxon signed rank test without adjustment for multiple comparisons.|Wilcoxon signed rank test|||||||<0.0001
72473095|NCT01495598|144470032|OTHER|P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.||||||0.005||||||The reported p-value is representative of the changes in levels of IL6 among all participants. Two tailed Wilcoxon signed rank test without adjustment for multiple comparisons.|Wilcoxon signed rank test|||||||0.005
72473096|NCT01495598|144470032|OTHER|P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.||||||0.06||||||The reported p-value is representative of the changes in levels of IL6 among all participants. Two tailed Wilcoxon signed rank test without adjustment for multiple comparisons.|Wilcoxon signed rank test|||||||0.06
72506824|NCT01377467|144545850|SUPERIORITY_OR_OTHER||between-subjects effect|0.707||||0.068|TWO_SIDED||||||repeated measures GLM||Within-subjects effect: p\<0.001. Time\*treatment interaction: p=0.047. The a priori threshold for statistical significance is \<0.05.|||||0.068
72506825|NCT01377467|144545851|SUPERIORITY_OR_OTHER||between-subjects effect|99952.126||||0.114|TWO_SIDED||||||repeated measures GLM||Within-subjects effect: p\<0.001. Time\*treatment interaction: p=0.047. The a priori threshold for statistical significance is \<0.05.|||||0.114
72473097|NCT01495598|144470032|OTHER|P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.||||||0.007||||||The reported p-value is representative of the changes in levels of IL6 among all participants. Two tailed Wilcoxon signed rank test without adjustment for multiple comparisons.|Wilcoxon signed rank test|||||||0.007
72473098|NCT01495598|144470032|OTHER|P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.||||||0.0003||||||The reported p-value is representative of the changes in levels of IL8 among all participants. Two tailed Wilcoxon signed rank test without adjustment for multiple comparisons.|Wilcoxon signed rank test|||||||0.0003
72473099|NCT01495598|144470032|OTHER|P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.||||||0.0002||||||The reported p-value is representative of the changes in levels of IL8 among all participants. Two tailed Wilcoxon signed rank test without adjustment for multiple comparisons.|Wilcoxon signed rank test|||||||0.0002
72473100|NCT01495598|144470032|OTHER|P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.||||||0.01||||||The reported p-value is representative of the changes in levels of IL8 among all participants. Two tailed Wilcoxon signed rank test without adjustment for multiple comparisons.|Wilcoxon signed rank test|||||||0.01
72473101|NCT01495598|144470032|OTHER|P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.||||||0.03||||||The reported p-value is representative of the changes in levels of IL6 among all participants. Two tailed Wilcoxon signed rank test without adjustment for multiple comparisons.|Wilcoxon signed rank test|||||||0.03
72473102|NCT01495598|144470032|OTHER|P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.||||||0.91||||||The reported p-value is representative of the changes in levels of IL10 among all participants. Two tailed Wilcoxon signed rank test without adjustment for multiple comparisons.|Wilcoxon signed rank test|||||||0.91
72506826|NCT01377467|144545852|SUPERIORITY_OR_OTHER||between-subjects effect|84.83||||0.578|TWO_SIDED||||||repeated measures GLM||Within-subjects effect: p\<0.001. Time\*treatment interaction: p=0.593. The a priori threshold for statistical significance is \<0.05.|||||0.578
72506827|NCT01377467|144545853|SUPERIORITY_OR_OTHER||between-subjects effect|248.686||||0.607|TWO_SIDED||||||repeated measures GLM||Within-subjects effect: p\<0.001. Time\*treatment interaction: p=0.296. The a priori threshold for statistical significance is \<0.05.|||||0.607
72506828|NCT01377467|144545854|SUPERIORITY_OR_OTHER||z value|-2.342||||0.019|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.019
72473103|NCT01495598|144470032|OTHER|P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.||||||0.64||||||The reported p-value is representative of the changes in levels of IL10 among all participants. Two tailed Wilcoxon signed rank test without adjustment for multiple comparisons.|Wilcoxon signed rank test|||||||0.64
72473104|NCT01495598|144470032|OTHER|P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.||||||0.7||||||The reported p-value is representative of the changes in levels of IL12 among all participants. Two tailed Wilcoxon signed rank test without adjustment for multiple comparisons.|Wilcoxon signed rank test|||||||0.70
72473105|NCT01495598|144470032|OTHER|P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.||||||0.59||||||The reported p-value is representative of the changes in levels of IL12 among all participants. Two tailed Wilcoxon signed rank test without adjustment for multiple comparisons.|Wilcoxon signed rank test|||||||0.59
72473106|NCT01495598|144470032|OTHER|P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.||||||0.26||||||The reported p-value is representative of the changes in levels of IL12 among all participants. Two tailed Wilcoxon signed rank test without adjustment for multiple comparisons.|Wilcoxon signed rank test|||||||0.26
72473107|NCT01495598|144470032|OTHER|P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.||||||0.0008||||||The reported p-value is representative of the changes in levels of IL13 among all participants. Two tailed Wilcoxon signed rank test without adjustment for multiple comparisons.|Wilcoxon signed rank test|||||||0.0008
72473108|NCT01495598|144470032|OTHER|P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.|||||<|0.0001||||||The reported p-value is representative of the changes in levels of IL13 among all participants. Two tailed Wilcoxon signed rank test without adjustment for multiple comparisons.|Wilcoxon signed rank test|||||||<0.0001
72473109|NCT01495598|144470032|OTHER|P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.||||||0.007||||||The reported p-value is representative of the changes in levels of IL13 among all participants. Two tailed Wilcoxon signed rank test without adjustment for multiple comparisons.|Wilcoxon signed rank test|||||||0.007
72473110|NCT01495598|144470032|OTHER|P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.||||||0.005||||||The reported p-value is representative of the changes in levels of TNFα among all participants. Two tailed Wilcoxon signed rank test without adjustment for multiple comparisons.|Wilcoxon signed rank test|||||||0.005
72506829|NCT01377467|144545855|SUPERIORITY_OR_OTHER||z value|-2.049||||0.042|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.042
72506830|NCT01377467|144545856|SUPERIORITY_OR_OTHER||z value|-0.937||||0.371|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.371
72473111|NCT01495598|144470032|OTHER|P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.||||||0.007||||||The reported p-value is representative of the changes in levels of TNFα among all participants. Two tailed Wilcoxon signed rank test without adjustment for multiple comparisons.|Wilcoxon signed rank test|||||||0.007
72506831|NCT01377467|144545857|SUPERIORITY_OR_OTHER||z value|-2.752||||0.005|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.005
72506832|NCT01377467|144545858|SUPERIORITY_OR_OTHER||z value|-2.166||||0.031|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.031
72506833|NCT01377467|144545859|SUPERIORITY_OR_OTHER||z value|-1.288||||0.212|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.212
72506834|NCT01377467|144545860|SUPERIORITY_OR_OTHER||z value|-1.64||||0.108|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.108
72506835|NCT01377467|144545861|SUPERIORITY_OR_OTHER||z value|-1.991||||0.048|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.048
72506836|NCT01354691|144545863|SUPERIORITY||||||<|0.67|||||||ANCOVA|||||||<0.67
72506837|NCT01354691|144545864|SUPERIORITY||||||<|0.21|||||||ANCOVA|||||||<0.21
72506838|NCT01354691|144545865|SUPERIORITY||||||<|0.78|||||||ANCOVA|||||||<0.78
72506839|NCT01354691|144545866|SUPERIORITY||||||=|0.83|||||||ANCOVA|||||||=0.83
72506840|NCT01354691|144545867|SUPERIORITY||||||=|0.77|||||||ANCOVA|||||||=.77
72506841|NCT02160977|144545868|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
72506842|NCT02160977|144545869|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
72506843|NCT02160977|144545870|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
72506844|NCT00410280|144545872|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.44||||0.0947|TWO_SIDED|95.0|-14.04|1.15|||ANOVA|||Repeated measures analysis of variance (ANOVA) model with fixed effects for treatment, time and interaction between treatment and time, and random effects for participant was used. Point estimate for difference between the treatment groups, corresponding 95 % confidence interval (CI) and p-value were derived from the model.||1.15|-14.04|0.0947
72506845|NCT00410280|144545873|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.24||||0.2673|TWO_SIDED|95.0|-11.84|3.35|||ANOVA|||Repeated measures ANOVA model with fixed effects for treatment, time and interaction between treatment and time, and random effects for participant was used. Point estimate for difference between the treatment groups, corresponding 95% CI and p-value were derived from the model.||3.35|-11.84|0.2673
72565812|NCT02709486|144662704|SUPERIORITY||Least Square Mean Difference|-0.66|STANDARD_ERROR_OF_MEAN|0.19||0.0005|TWO_SIDED|95.0|-1.03|-0.29|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.||-0.29|-1.03|0.0005
72565813|NCT02709486|144662704|SUPERIORITY||Least Square Mean Difference|-0.77|STANDARD_ERROR_OF_MEAN|0.19|<|0.0001|TWO_SIDED|95.0|-1.13|-0.4|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.||-0.40|-1.13|<.0001
72565814|NCT02709486|144662704|SUPERIORITY||Least Square Mean Difference|-0.44|STANDARD_ERROR_OF_MEAN|0.2||0.0246|TWO_SIDED|95.0|-0.82|-0.06|||ANCOVA|||Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.||-0.06|-0.82|0.0246
72506846|NCT00410280|144545874|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-23.8||||0.0391|TWO_SIDED|95.0|-46.35|-1.24|||ANOVA|||Day 14: Repeated measures ANOVA model with fixed effects for treatment, time and interaction between treatment and time, and random effects for participant was used. Point estimate for difference between the treatment groups, corresponding 95% CI and p-value were derived from the model.||-1.24|-46.35|0.0391
72506847|NCT00410280|144545874|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.17||||0.1326|TWO_SIDED|95.0|-39.72|5.39|||ANOVA|||Day 35: Repeated measures ANOVA model with fixed effects for treatment, time and interaction between treatment and time, and random effects for participant was used. Point estimate for difference between the treatment groups, corresponding 95% CI and p-value were derived from the model.||5.39|-39.72|0.1326
72506848|NCT00410280|144545875|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.76||||0.0423|TWO_SIDED|95.0|-19.16|-0.35|||ANOVA|||Day 14: Repeated measures ANOVA model with fixed effects for treatment, time and interaction between treatment and time, and random effects for participant was used. Point estimate for difference between the treatment groups, corresponding 95% CI and p-value were derived from the model.||-0.35|-19.16|0.0423
72565815|NCT02709486|144662704|SUPERIORITY||Least Square Mean Difference|-0.71|STANDARD_ERROR_OF_MEAN|0.2||0.0003|TWO_SIDED|95.0|-1.1|-0.33|||ANCOVA|||Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.||-0.33|-1.10|0.0003
72398012|NCT01291173|144301961|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0091|TWO_SIDED|95.0|||||Chi-squared|||||||0.0091
72506849|NCT00410280|144545875|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.06||||0.3902|TWO_SIDED|95.0|-13.46|5.35|||ANOVA|||Day 35: Repeated measures ANOVA model with fixed effects for treatment, time and interaction between treatment and time, and random effects for participant was used. Point estimate for difference between the treatment groups, corresponding 95% CI and p-value were derived from the model.||5.35|-13.46|0.3902
72506850|NCT00410280|144545876|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.05||||0.0302|TWO_SIDED|95.0|-36.21|-1.9|||ANOVA|||Day 14: Repeated measures ANOVA model with fixed effects for treatment, time and interaction between treatment and time, and random effects for participant was used. Point estimate for difference between the treatment groups, corresponding 95% CI and p-value were derived from the model.||-1.90|-36.21|0.0302
72506851|NCT00410280|144545876|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.19||||0.1289|TWO_SIDED|95.0|-30.34|3.97|||ANOVA|||Day 35: Repeated measures ANOVA model with fixed effects for treatment, time and interaction between treatment and time, and random effects for participant was used. Point estimate for difference between the treatment groups, corresponding 95% CI and p-value were derived from the model.||3.97|-30.34|0.1289
72506852|NCT00410280|144545877|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.09||||0.8469|TWO_SIDED|95.0|-0.79|0.96|||Mixed Models Analysis|||Screening: Mixed model with fixed effects for treatment, time and interaction between treatment and time, and random effects for participants was used. Point estimate for difference between the treatment groups, corresponding 95% CI and p-values were derived from the model.||0.96|-0.79|0.8469
72565816|NCT02709486|144662707|SUPERIORITY||Least Square Mean Difference|1.2|STANDARD_ERROR_OF_MEAN|2.57||0.6427|TWO_SIDED|95.0|-3.9|6.29|||ANCOVA|||Week 8: Percent Work Time Missed: WPAI parameters were analyzed using ANCOVA model which included covariates of the corresponding baseline score, baseline diary average pain, index joint, highest Kellgren-Lawrence grade (2, 3 or 4), and treatment, with study site as a random effect.||6.29|-3.90|0.6427
72473112|NCT01495598|144470032|OTHER|P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.||||||0.007||||||The reported p-value is representative of the changes in levels of TNFα among all participants. Two tailed Wilcoxon signed rank test without adjustment for multiple comparisons.|Wilcoxon signed rank test|||||||0.007
72473113|NCT01495598|144470032|OTHER|P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.||||||0.42||||||The reported p-value is representative of the changes in levels of IP-10 among all participants. Two tailed Wilcoxon signed rank test without adjustment for multiple comparisons.|Wilcoxon signed rank test|||||||0.42
72506853|NCT00410280|144545877|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.9995|TWO_SIDED|95.0|-0.86|0.86|||Mixed Models Analysis|||Day 14: Mixed model with fixed effects for treatment, time and interaction between treatment and time, and random effects for participants was used. Point estimate for difference between the treatment groups, corresponding 95% CI and p-values were derived from the model.||0.86|-0.86|0.9995
72506854|NCT00410280|144545877|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.28||||0.528|TWO_SIDED|95.0|-1.14|0.59|||Mixed Models Analysis|||Day 35: Mixed model with fixed effects for treatment, time and interaction between treatment and time, and random effects for participants was used. Point estimate for difference between the treatment groups, corresponding 95% CI and p-values were derived from the model.||0.59|-1.14|0.5280
72506855|NCT00408421|144545925|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for treatment effect at last visit. Effects evaluated based on 2-sided significance level=0.05. Model: treatment, NSAID use, investigator, week, treatment-by-week interaction, baseline score and baseline-by-week interaction.|Mixed-Effects Model Repeated Measures|No adjustments for multiple comparisons were made.||Null hypothesis: the difference in 24-hour average pain score between duloxetine and placebo treatment groups at last visit of treatment phase is zero. This study will have at least 80% power to detect a treatment group difference of 1.0 point in the baseline-to-endpoint mean change on the weekly mean of 24-hour average pain severity between duloxetine and placebo treatment groups based on Baseline Observation Carried Forward (BOCF).||||<0.001
72506856|NCT00408421|144545926|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.53||||0.001||95.0|-0.84|-0.21||Treatment effects and interaction effects were evaluated based on a two-sided significance level of 0.05. No adjustments for multiple comparisons were made.|ANCOVA|||An analysis of covariance (ANCOVA) model was used which contains the terms of treatment, NSAID use (Yes/No), PGI severity at baseline, and investigator. Type III sum-of-squares for the least-squares mean (LSMean) was used to test the null hypothesis that there is no treatment difference on the mean outcome measure at endpoint.||-0.21|-0.84|0.001
72506857|NCT00408421|144545927|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.41||||0.003||95.0|-2.33|-0.48||P-value for Change from Baseline. Treatment effects and interaction effects were evaluated based on a two-sided significance level of 0.05. No adjustments for multiple comparisons were made. Change=Endpoint-Baseline.|ANCOVA||Mean Difference = Duloxetine minus Placebo|An analysis of covariance (ANCOVA) model was used which contains the terms of treatment, NSAID use (Yes/No), the outcome score at baseline, and investigator. Type III sum-of-squares for the least-squares mean (LSMean) was used to test the null hypothesis that there is no treatment difference on the mean change from baseline to the endpoint of the outcome measure.||-0.48|-2.33|0.003
72506858|NCT00408421|144545928|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.65||||0.004||95.0|-1.09|-0.22||P-value for Change from Baseline. Treatment effects and interaction effects were evaluated based on a two-sided significance level of 0.05. No adjustments for multiple comparisons were made. Change=Endpoint-Baseline.|ANCOVA||Mean Difference = Duloxetine minus Placebo|An analysis of covariance (ANCOVA) model was used which contains the terms of treatment, NSAID use (Yes/No), the outcome score at baseline, and investigator. Type III sum-of-squares for the least-squares mean (LSMean) was used to test the null hypothesis that there is no treatment difference on the mean change from baseline to the endpoint of the outcome measure.||-0.22|-1.09|0.004
72506859|NCT00408421|144545929|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.18||||0.001||95.0|-8.33|-2.03||P-value for Change from Baseline. Treatment effects and interaction effects were evaluated based on a two-sided significance level of 0.05. No adjustments for multiple comparisons were made. Change=Endpoint-Baseline.|ANCOVA||Mean Difference = Duloxetine minus Placebo|An analysis of covariance (ANCOVA) model was used which contains the terms of treatment, NSAID use (Yes/No), the outcome score at baseline, and investigator. Type III sum-of-squares for the least-squares mean (LSMean) was used to test the null hypothesis that there is no treatment difference on the mean change from baseline to the endpoint of the outcome measure.||-2.03|-8.33|0.001
72506860|NCT00408421|144545930|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-6.42||||0.004||95.0|-10.72|-2.11||P-value for Change from Baseline. Treatment effects and interaction effects were evaluated based on a two-sided significance level of 0.05. No adjustments for multiple comparisons were made. Change=Endpoint-Baseline.|ANCOVA||Mean Difference = Duloxetine minus Placebo|An analysis of covariance (ANCOVA) model was used which contains the terms of treatment, NSAID use (Yes/No), the outcome score at baseline, and investigator. Type III sum-of-squares for the least-squares mean (LSMean) was used to test the null hypothesis that there is no treatment difference on the mean change from baseline to the endpoint of the outcome measure.||-2.11|-10.72|0.004
72565817|NCT02709486|144662707|SUPERIORITY||Least Square Mean Difference|-2.09|STANDARD_ERROR_OF_MEAN|2.59||0.4208|TWO_SIDED|95.0|-7.22|3.04|||ANCOVA|||Week 8: Percent Work Time Missed: WPAI parameters were analyzed using ANCOVA model which included covariates of the corresponding baseline score, baseline diary average pain, index joint, highest Kellgren-Lawrence grade (2, 3 or 4), and treatment, with study site as a random effect.||3.04|-7.22|0.4208
72565818|NCT02709486|144662707|SUPERIORITY||Least Square Mean Difference|-0.62|STANDARD_ERROR_OF_MEAN|2.73||0.8204|TWO_SIDED|95.0|-6.03|4.79|||ANCOVA|||Week 16: Percent Work Time Missed: WPAI parameters were analyzed using ANCOVA model which included covariates of the corresponding baseline score, baseline diary average pain, index joint, highest Kellgren-Lawrence grade (2, 3 or 4), and treatment, with study site as a random effect.||4.79|-6.03|0.8204
72565819|NCT02709486|144662707|SUPERIORITY||Least Square Mean Difference|-4.52|STANDARD_ERROR_OF_MEAN|2.85||0.1157|TWO_SIDED|95.0|-10.16|1.13|||ANCOVA|||Week 16: Percent Work Time Missed: WPAI parameters were analyzed using ANCOVA model which included covariates of the corresponding baseline score, baseline diary average pain, index joint, highest Kellgren-Lawrence grade (2, 3 or 4), and treatment, with study site as a random effect.||1.13|-10.16|0.1157
72473114|NCT01495598|144470032|OTHER|P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.||||||0.85||||||The reported p-value is representative of the changes in levels of IP-10 among all participants. Two tailed Wilcoxon signed rank test without adjustment for multiple comparisons.|Wilcoxon signed rank test|||||||0.85
72473115|NCT01495598|144470032|OTHER|P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.||||||0.16||||||The reported p-value is representative of the changes in levels of IP-10 among all participants. Two tailed Wilcoxon signed rank test without adjustment for multiple comparisons.|Wilcoxon signed rank test|||||||0.16
72473116|NCT01495598|144470033|OTHER|P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.||||||0.07||||||The reported p-value is representative of the changes in levels of CD4+ cells/µL among all participants.|Wilcoxon signed rank test|||||||0.07
72473117|NCT01495598|144470033|NON_INFERIORITY|P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.||||||0.13||||||The reported p-value is representative of the changes in levels of CD4+cells/µL among all participants.|Wilcoxon signed rank test|||||||0.13
72506861|NCT00408421|144545931|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.83||||0.005||95.0|-1.4|-0.25||P-value for Change from Baseline. Treatment effects and interaction effects were evaluated based on a two-sided significance level of 0.05. No adjustments for multiple comparisons were made. Change=Endpoint-Baseline.|ANCOVA||Mean Difference = Duloxetine minus Placebo|An analysis of covariance (ANCOVA) model was used which contains the terms of treatment, NSAID use (Yes/No), the outcome score at baseline, and investigator. Type III sum-of-squares for the least-squares mean (LSMean) was used to test the null hypothesis that there is no treatment difference on the mean change from baseline to the endpoint of the outcome measure.||-0.25|-1.40|0.005
72473118|NCT01495598|144470033|OTHER|P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.||||||0.15||||||The reported p-value is representative of the changes in levels of CD4+cells/µL among all participants.|Wilcoxon signed rank test|||||||0.15
72473119|NCT01495598|144470033|OTHER|P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.||||||0.03||||||The reported p-value is representative of the changes in levels of CD4+cells/µL among HIV+ participants.|Wilcoxon signed rank test|||||||0.03
72506862|NCT00408421|144545932|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for treatment effect at last visit. Effects evaluated based on 2-sided significance level=0.05. Model: treatment, NSAID use, investigator, week, treatment-by-week interaction, baseline score and baseline-by-week interaction.|Mixed-Effects Model Repeated Measures|No adjustments for multiple comparisons were made.||||||<0.001
72506863|NCT00408421|144545933|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.87||||0.039||95.0|-1.69|-0.05||P-value for Change from Baseline. Treatment effects and interaction effects were evaluated based on a two-sided significance level of 0.05. No adjustments for multiple comparisons were made. Change=Endpoint-baseline.|ANCOVA||Mean Difference = Duloxetine minus Placebo|An analysis of covariance (ANCOVA) model was used which contains the terms of treatment, NSAID use (Yes/No), the outcome score at baseline, and investigator. Type III sum-of-squares for the least-squares mean (LSMean) was used to test the null hypothesis that there is no treatment difference on the mean change from baseline to the endpoint of the outcome measure.||-0.05|-1.69|0.039
72623058|NCT02904096|144776394|OTHER|||||||0.01|||||||t-test, 1 sided|||Comparison between Group A: Hand palmar pinch strength (Left Hand)-baseline and Group A: Hand palmar pinch strength (Left Hand)-change from baseline at Month 24.||||.010
72473120|NCT01495598|144470033|OTHER|P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.||||||0.06||||||The reported p-value is representative of the changes in levels of CD4+cells/µL among HIV+ participants.|Wilcoxon signed rank test|||||||0.06
72473121|NCT01495598|144470033|OTHER|P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.||||||0.79||||||The reported p-value is representative of the changes in levels of CD4+cells/µL among HIV+ participants.|Wilcoxon rank sum test|||||||0.79
72473122|NCT01495598|144470033|OTHER|P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.||||||0.03||||||The reported p-value is representative of the changes in levels of CD8+ cells/µL among all participants.|Wilcoxon signed rank test|||||||0.03
72473123|NCT01495598|144470033|OTHER|P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.||||||0.008||||||The reported p-value is representative of the changes in levels of CD8+ cells/µL among all participants.|Wilcoxon signed rank test|||||||0.008
72473124|NCT01495598|144470033|OTHER|P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.||||||0.12||||||The reported p-value is representative of the changes in levels of CD8+ cells/µL among all participants.|Wilcoxon signed rank test|||||||0.12
72473125|NCT01495598|144470033|OTHER|P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.||||||0.02||||||The reported p-value is representative of the changes in levels of CD8+ cells/µL among HIV+ participants.|Wilcoxon signed rank test|||||||0.02
72473126|NCT01495598|144470033|OTHER|P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.||||||0.02||||||The reported p-value is representative of the changes in levels of CD8+ cells/µL among HIV+ participants.|Wilcoxon signed rank test|||||||0.02
72473127|NCT01495598|144470033|OTHER|P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.||||||0.36||||||The reported p-value is representative of the changes in levels of CD8+ cells/µL among HIV+ participants.|Wilcoxon signed rank test|||||||0.36
72473128|NCT01495598|144470033|OTHER|P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.||||||0.002||||||The reported p-value is representative of the changes in levels of CD19+ cells/µL among all participants.|Wilcoxon signed rank test|||||||0.002
72473129|NCT01495598|144470033|OTHER|P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.||||||0.0002||||||The reported p-value is representative of the changes in levels of CD19+ cells/µL among all participants.|Wilcoxon signed rank test|||||||0.0002
72473130|NCT01495598|144470033|OTHER|P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.|||||<|0.0001||||||The reported p-value is representative of the changes in levels of CD19+ cells/µL among all participants.|Wilcoxon signed rank test|||||||<0.0001
72506864|NCT00408421|144545934|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.35||||0.001||95.0|-0.56|-0.14||P-value for Change from Baseline. Treatment effects and interaction effects were evaluated based on a two-sided significance level of 0.05. No adjustments for multiple comparisons were made. Change=Endpoint-baseline.|ANCOVA||Mean Difference = Duloxetine minus Placebo|An analysis of covariance (ANCOVA) model was used which contains the terms of treatment, NSAID use (Yes/No), the outcome score at baseline, and investigator. Type III sum-of-squares for the least-squares mean (LSMean) was used to test the null hypothesis that there is no treatment difference on the mean change from baseline to the endpoint of the outcome measure.||-0.14|-0.56|0.001
72506865|NCT00408421|144545935|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.06|||<|0.001||95.0|-1.66|-0.46||P-value for Change from Baseline. Treatment effects and interaction effects were evaluated based on a two-sided significance level of 0.05. No adjustments for multiple comparisons were made. Change=Endpoint-baseline.|ANCOVA||Mean Difference = Duloxetine minus Placebo|An analysis of covariance (ANCOVA) model was used which contains the terms of treatment, NSAID use (Yes/No), the outcome score at baseline, and investigator. Type III sum-of-squares for the least-squares mean (LSMean) was used to test the null hypothesis that there is no treatment difference on the mean change from baseline to the endpoint of the outcome measure.||-0.46|-1.66|<0.001
72506866|NCT00408421|144545936|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.76||||0.004||95.0|-1.28|-0.24||P-value for Change from Baseline. Treatment effects and interaction effects were evaluated based on a two-sided significance level of 0.05. No adjustments for multiple comparisons were made. Change=Endpoint-baseline.|ANCOVA||Mean Difference = Duloxetine minus Placebo|An analysis of covariance (ANCOVA) model was used which contains the terms of treatment, NSAID use (Yes/No), the outcome score at baseline, and investigator. Type III sum-of-squares for the least-squares mean (LSMean) was used to test the null hypothesis that there is no treatment difference on the mean change from baseline to the endpoint of the outcome measure.||-0.24|-1.28|0.004
72506867|NCT00408421|144545937|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.97|||<|0.001||95.0|-1.52|-0.42||P-value for Change from Baseline. Treatment effects and interaction effects were evaluated based on a two-sided significance level of 0.05. No adjustments for multiple comparisons were made. Change=Endpoint-baseline.|ANCOVA||Mean Difference = Duloxetine minus Placebo|An analysis of covariance (ANCOVA) model was used which contains the terms of treatment, NSAID use (Yes/No), the outcome score at baseline, and investigator. Type III sum-of-squares for the least-squares mean (LSMean) was used to test the null hypothesis that there is no treatment difference on the mean change from baseline to the endpoint of the outcome measure.||-0.42|-1.52|<0.001
72506868|NCT00408421|144545938|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.91||||0.003||95.0|-1.5|-0.32||P-value for Change from Baseline. Treatment effects and interaction effects were evaluated based on a two-sided significance level of 0.05. No adjustments for multiple comparisons were made. Change=Endpoint-baseline.|ANCOVA||Mean Difference = Duloxetine minus Placebo|An analysis of covariance (ANCOVA) model was used which contains the terms of treatment, NSAID use (Yes/No), the outcome score at baseline, and investigator. Type III sum-of-squares for the least-squares mean (LSMean) was used to test the null hypothesis that there is no treatment difference on the mean change from baseline to the endpoint of the outcome measure.||-0.32|-1.50|0.003
72506869|NCT00408421|144545939|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.71||||0.019||95.0|-1.3|-0.12||P-value for Change from Baseline. Treatment effects and interaction effects were evaluated based on a two-sided significance level of 0.05. No adjustments for multiple comparisons were made. Change=Endpoint-baseline.|ANCOVA||Mean Difference = Duloxetine minus Placebo|An analysis of covariance (ANCOVA) model was used which contains the terms of treatment, NSAID use (Yes/No), the outcome score at baseline, and investigator. Type III sum-of-squares for the least-squares mean (LSMean) was used to test the null hypothesis that there is no treatment difference on the mean change from baseline to the endpoint of the outcome measure.||-0.12|-1.30|0.019
72565820|NCT02709486|144662707|SUPERIORITY||Least Square Mean Difference|-1.32|STANDARD_ERROR_OF_MEAN|2.41||0.5845|TWO_SIDED|95.0|-6.12|3.47|||ANCOVA|||Week 24: Percent Work Time Missed: WPAI parameters were analyzed using ANCOVA model which included covariates of the corresponding baseline score, baseline diary average pain, index joint, highest Kellgren-Lawrence grade (2, 3 or 4), and treatment, with study site as a random effect.||3.47|-6.12|0.5845
72473131|NCT01495598|144470034|OTHER|P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.||||||0.13|||||||Wilcoxon signed rank test|||||||0.13
72473132|NCT01495598|144470034|OTHER|P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.||||||0.65|||||||Wilcoxon signed rank test|||||||0.65
72473133|NCT01495598|144470034|OTHER|P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.||||||0.32|||||||Wilcoxon signed rank test|||||||0.32
72473134|NCT01495598|144470034|OTHER|P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.||||||0.06|||||||Wilcoxon signed rank test|||||||0.06
72473135|NCT01495598|144470034|OTHER|P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.||||||0.007|||||||Wilcoxon signed rank test|||||||0.007
72398013|NCT01291173|144301961|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0004|TWO_SIDED|95.0|||||Chi-squared|||||||0.0004
72473136|NCT01495598|144470035|OTHER|P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.||||||0.56|||||||Wilcoxon signed rank test|||||||0.56
72473137|NCT01495598|144470035|OTHER|P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.||||||0.65|||||||Wilcoxon signed rank test|||||||0.65
72473138|NCT01495598|144470035|OTHER|P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.||||||0.56|||||||Wilcoxon signed rank test|||||||0.56
72473139|NCT05140915|144470064|SUPERIORITY|||||||0.77|||||||t-test, 2 sided|||||||.77
72473140|NCT03746392|144470096|SUPERIORITY|||||||0.036|||||||Fisher Exact|||||||0.036
72473141|NCT04777864|144470109|SUPERIORITY|||||||0.18|||||||t-test, 2 sided|||Parent group only||||0.18
72473142|NCT04777864|144470109|SUPERIORITY|||||||0.91|||||||t-test, 2 sided|||Adolescent group only||||0.91
72473143|NCT04777864|144470110|SUPERIORITY|||||||0.975|||||||Regression, Linear|||Parent: Post-Index Visit||||0.975
72473144|NCT04777864|144470110|SUPERIORITY|||||||0.854|||||||Regression, Linear|||Adolescent: Post-Index Visit||||0.854
72473145|NCT04777864|144470113|SUPERIORITY|||||||0.03|||||||t-test, 2 sided|||Post-Index Visit||||0.03
72473146|NCT04777864|144470113|SUPERIORITY|||||||0.21|||||||t-test, 2 sided|||3 months after initial clinic visit||||0.21
72473147|NCT04777864|144470114|SUPERIORITY|||||||0.76|||||||t-test, 2 sided|||Baseline||||0.76
72473148|NCT04777864|144470114|SUPERIORITY|||||||0.96|||||||t-test, 2 sided|||Post-Index Visit||||0.96
72473149|NCT04777864|144470114|SUPERIORITY|||||||0.96|||||||t-test, 2 sided|||3 months after initial clinic visit||||0.96
72506870|NCT00408421|144545940|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.4||||0.164||95.0|-0.97|0.17||P-value for Change from Baseline. Treatment effects and interaction effects were evaluated based on a two-sided significance level of 0.05. No adjustments for multiple comparisons were made. Change=Endpoint-baseline.|ANCOVA||Mean Difference = Duloxetine minus Placebo|An analysis of covariance (ANCOVA) model was used which contains the terms of treatment, NSAID use (Yes/No), the outcome score at baseline, and investigator. Type III sum-of-squares for the least-squares mean (LSMean) was used to test the null hypothesis that there is no treatment difference on the mean change from baseline to the endpoint of the outcome measure.||0.17|-0.97|0.164
72506871|NCT00408421|144545941|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.63||||0.049||95.0|-1.25|0.0||P-value for Change from Baseline. Treatment effects and interaction effects were evaluated based on a two-sided significance level of 0.05. No adjustments for multiple comparisons were made. Change=Endpoint-baseline.|ANCOVA||Mean Difference = Duloxetine minus Placebo|An analysis of covariance (ANCOVA) model was used which contains the terms of treatment, NSAID use (Yes/No), the outcome score at baseline, and investigator. Type III sum-of-squares for the least-squares mean (LSMean) was used to test the null hypothesis that there is no treatment difference on the mean change from baseline to the endpoint of the outcome measure.||0.00|-1.25|0.049
72542449|NCT00106028|144614668|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.537||||0.6103|TWO_SIDED|95.0|-4.424|7.497|||ANCOVA|LS means and p-value are from ANCOVA model adjusted by baseline and fixed effects for age group, treatment and pooled center for post-baseline.||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.||7.497|-4.424|0.6103
72623059|NCT02904096|144776394|OTHER|||||||0.06|||||||t-test, 1 sided|||Comparison between Group A: Hand palmar pinch strength (Right Hand)-baseline and Group A: Hand palmar pinch strength (Right Hand)-change from baseline at Month 24.||||.060
72473150|NCT01647542|144470115|SUPERIORITY_OR_OTHER||Least squares mean difference|-1.03|STANDARD_ERROR_OF_MEAN|0.126|<|0.001|TWO_SIDED|95.0|-1.27|-0.78||Stepwise Comparison: 1) TAK-875 50 mg versus (vs.) placebo, 2) TAK-875 25 mg vs. placebo. Step 2 was performed only if p-value at step 1 was \<=0.050.|Mixed Model Repeated Measures|Treatment, country, visit, and visit-by-treatment interaction as fixed factors, baseline value as covariate.||Assuming a standard deviation of 0.9% in change from baseline in HbA1c to Week 24 and a dropout rate of 15%, 210 participants per group provided at least 95% power to detect a treatment difference of 0.5% between treatment arms at a 2-sided significance level of 0.05.||-0.78|-1.27|<0.001
72473151|NCT01647542|144470115|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.82|STANDARD_ERROR_OF_MEAN|0.126|<|0.001|TWO_SIDED|95.0|-1.07|-0.57||Stepwise Comparison: 1) TAK-875 50 mg versus (vs.) placebo, 2) TAK-875 25 mg vs. placebo. Step 2 was performed only if p-value at step 1 was \<=0.050.|Mixed Model Repeated Measures|Treatment, country, visit, and visit-by-treatment interaction as fixed factors, baseline value as covariate.||Assuming a standard deviation of 0.9% in change from baseline in HbA1c to Week 24 and a dropout rate of 15%, 210 participants per group provided at least 95% power to detect a treatment difference of 0.5% between treatment arms at a 2-sided significance level of 0.05.||-0.57|-1.07|<0.001
72473152|NCT01647542|144470116|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.66|||<|0.001|TWO_SIDED|95.0|2.99|10.72||No multiplicity adjustment.|Regression, Logistic|Treatment and baseline HbA1c as explanatory variables.||||10.72|2.99|<0.001
72473153|NCT01647542|144470116|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.42|||<|0.001|TWO_SIDED|95.0|1.81|6.49||No multiplicity adjustment.|Regression, Logistic|Treatment and baseline HbA1c as explanatory variables.||||6.49|1.81|<0.001
72473154|NCT01647542|144470117|SUPERIORITY_OR_OTHER||Least squares mean difference|-35.6|STANDARD_ERROR_OF_MEAN|4.36|<|0.001|TWO_SIDED|95.0|-44.2|-26.9||No multiplicity adjustment.|Mixed Model Repeated Measures|Treatment, country, visit, and visit-by-treatment interaction as fixed factors, baseline value covariate.||||-26.9|-44.2|<0.001
72473155|NCT01647542|144470117|SUPERIORITY_OR_OTHER||Least Squares mean Difference|-35.7|STANDARD_ERROR_OF_MEAN|4.36|<|0.001|TWO_SIDED|95.0|-44.3|-27.1||No multiplicity adjustment.|Mixed Model Repeated Measures|Treatment, country, visit, and visit-by-treatment interaction as fixed factors, baseline value as covariate.||||-27.1|-44.3|<0.001
72473156|NCT01647542|144470118|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|5.9|STANDARD_ERROR_OF_MEAN|29.72||0.846|TWO_SIDED|95.0|-57.9|69.6||No multiplicity adjustments.|ANCOVA|Treatment and country as fixed factors and baseline value as covariate.||||69.6|-57.9|0.846
72473157|NCT01647542|144470118|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-24.9|STANDARD_ERROR_OF_MEAN|30.4||0.427|TWO_SIDED|95.0|-90.1|40.3||No multiplicity adjustments.|ANCOVA|Treatment and country as fixed factors and baseline value as covariate.||||40.3|-90.1|0.427
72398014|NCT01291173|144301961|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED|95.0|||||Chi-squared|||||||<0.0001
72398015|NCT01291173|144301962|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.97||||0.0142|TWO_SIDED|95.0|-5.34|-0.6|||Mixed Models Analysis|||||-0.60|-5.34|0.0142
72473158|NCT03086655|144470119|SUPERIORITY||Odds Ratio (OR)|1.32|||||TWO_SIDED|95.0|0.9|1.93|||||This is the 'inflation part' of the zero inflated negative binomial model. We used cluster robust standard errors due to the multiple observations over time being nested within participant. Result shows odds of intervention group relative to control.|"We used zero inflated negative binomial regression due to the count variable being overdispersed and containing a large number of 0. The analysis aggregated over multiple time points per participant. It simultaneously tests the odds of having 0 openings and the difference in the rate of openings between the 2 intervention groups. These 2 results are reported separately.~Null hypothesis 1: the odds of having 0 openings is lower in intervention than control group."||1.93|0.90|
72473159|NCT03086655|144470119|SUPERIORITY||incidence rate ratio (IRR)|0.77|||||TWO_SIDED|95.0|0.61|0.98|||||This is the negative binomial part of the model. We used cluster robust standard errors due to the multiple observations being nested within participant. Result shows intervention group had lower rate of openings relative to control.|"We used zero inflated negative binomial regression due to the count variable being overdispersed and containing many 0s. The analysis aggregated over multiple time points per participant. It simultaneously tests the odds of having 0 openings and the difference in the rate of openings between the 2 intervention groups. These 2 results are reported separately.~Null hypothesis 2: the incidence rate ratio for # days with box opening is \>1, i.e. more openings in intervention than control group."||0.98|0.61|
72506872|NCT00408421|144545942|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.51||||0.093||95.0|-1.1|0.08||P-value for Change from Baseline. Treatment effects and interaction effects were evaluated based on a two-sided significance level of 0.05. No adjustments for multiple comparisons were made. Change=Endpoint-baseline.|ANCOVA||Mean Difference = Duloxetine minus Placebo|An analysis of covariance (ANCOVA) model was used which contains the terms of treatment, NSAID use (Yes/No), the outcome score at baseline, and investigator. Type III sum-of-squares for the least-squares mean (LSMean) was used to test the null hypothesis that there is no treatment difference on the mean change from baseline to the endpoint of the outcome measure.||0.08|-1.10|0.093
72506873|NCT00408421|144545943|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.29||||0.287||95.0|-0.82|0.24||P-value for Change from Baseline. Treatment effects and interaction effects were evaluated based on a two-sided significance level of 0.05. No adjustments for multiple comparisons were made. Change=Endpoint-baseline.|ANCOVA||Mean Difference = Duloxetine minus Placebo|An analysis of covariance (ANCOVA) model was used which contains the terms of treatment, NSAID use (Yes/No), the outcome score at baseline, and investigator. Type III sum-of-squares for the least-squares mean (LSMean) was used to test the null hypothesis that there is no treatment difference on the mean change from baseline to the endpoint of the outcome measure.||0.24|-0.82|0.287
72506874|NCT00408421|144545944|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.64||||0.033||95.0|-1.23|-0.05||P-value for Change from Baseline. Treatment effects and interaction effects were evaluated based on a two-sided significance level of 0.05. No adjustments for multiple comparisons were made. Change=Endpoint-baseline.|ANCOVA||Mean Difference = Duloxetine minus Placebo|An analysis of covariance (ANCOVA) model was used which contains the terms of treatment, NSAID use (Yes/No), the outcome score at baseline, and investigator. Type III sum-of-squares for the least-squares mean (LSMean) was used to test the null hypothesis that there is no treatment difference on the mean change from baseline to the endpoint of the outcome measure.||-0.05|-1.23|0.033
72506875|NCT00408421|144545945|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.78||||0.015||95.0|-1.4|-0.15||P-value for Change from Baseline. Treatment effects and interaction effects were evaluated based on a two-sided significance level of 0.05. No adjustments for multiple comparisons were made. Change=Endpoint-baseline.|ANCOVA||Mean Difference = Duloxetine minus Placebo|An analysis of covariance (ANCOVA) model was used which contains the terms of treatment, NSAID use (Yes/No), the outcome score at baseline, and investigator. Type III sum-of-squares for the least-squares mean (LSMean) was used to test the null hypothesis that there is no treatment difference on the mean change from baseline to the endpoint of the outcome measure.||-0.15|-1.40|0.015
72506876|NCT00408421|144545946|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.56||||0.029||95.0|-1.06|-0.06||P-value for Change from Baseline. Treatment effects and interaction effects were evaluated based on a two-sided significance level of 0.05. No adjustments for multiple comparisons were made. Change=Endpoint-baseline.|ANCOVA||Mean Difference = Duloxetine minus Placebo|An analysis of covariance (ANCOVA) model was used which contains the terms of treatment, NSAID use (Yes/No), the outcome score at baseline, and investigator. Type III sum-of-squares for the least-squares mean (LSMean) was used to test the null hypothesis that there is no treatment difference on the mean change from baseline to the endpoint of the outcome measure.||-0.06|-1.06|0.029
72506877|NCT00408421|144545947|SUPERIORITY_OR_OTHER|||||||0.033||95.0|||||Fisher Exact|||This study will also have at least 85% power to detect a treatment group difference of 25% in the response rates (≥30% reduction from baseline) based on the weekly mean of 24-hour average pain severity between duloxetine and placebo treatment groups.||||0.033
72506878|NCT00408421|144545948|SUPERIORITY_OR_OTHER|||||||0.075||95.0|||||Fisher Exact|||This study will also have at least 85% power to detect a treatment group difference of 25% in the response rates (≥30% reduction from baseline) based on the weekly mean of 24-hour average pain severity between duloxetine and placebo treatment groups.||||0.075
72506879|NCT00408421|144545949|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.83||||0.088||95.0|-0.28|3.94||P-value for Change from Baseline. Treatment effects and interaction effects were evaluated based on a two-sided significance level of 0.05. No adjustments for multiple comparisons were made. Change=Endpoint-baseline.|ANCOVA||Mean Difference = Duloxetine minus Placebo|An analysis of covariance (ANCOVA) model was used which contains the terms of treatment, NSAID use (Yes/No), the outcome score at baseline, and investigator. Type III sum-of-squares for the least-squares mean (LSMean) was used to test the null hypothesis that there is no treatment difference on the mean change from baseline to the endpoint of the outcome measure.||3.94|-0.28|0.088
72506880|NCT00408421|144545950|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.87||||0.08||95.0|-0.22|3.96||P-value for Change from Baseline. Treatment effects and interaction effects were evaluated based on a two-sided significance level of 0.05. No adjustments for multiple comparisons were made. Change=Endpoint-baseline.|ANCOVA||Mean Difference = Duloxetine minus Placebo|An analysis of covariance (ANCOVA) model was used which contains the terms of treatment, NSAID use (Yes/No), the outcome score at baseline, and investigator. Type III sum-of-squares for the least-squares mean (LSMean) was used to test the null hypothesis that there is no treatment difference on the mean change from baseline to the endpoint of the outcome measure.||3.96|-0.22|0.080
72565821|NCT02709486|144662707|SUPERIORITY||Least Square Mean Difference|-2.93|STANDARD_ERROR_OF_MEAN|2.54||0.2514|TWO_SIDED|95.0|-7.97|2.11|||ANCOVA|||Week 24: Percent Work Time Missed: WPAI parameters were analyzed using ANCOVA model which included covariates of the corresponding baseline score, baseline diary average pain, index joint, highest Kellgren-Lawrence grade (2, 3 or 4), and treatment, with study site as a random effect.||2.11|-7.97|0.2514
72398016|NCT01291173|144301962|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.25||||0.0075|TWO_SIDED|95.0|-5.62|-0.88|||Mixed Models Analysis|||||-0.88|-5.62|0.0075
72473160|NCT03086655|144470120|SUPERIORITY|||||||0.08|||||||Chi-squared|overall Wald chi2 (2 d.f.), simultaneously testing if parameters for both 6 mo. by intervention and 12 mo. by intervention are different from 0.||"statistical analyses is a GEE model with logit link function and binomial distribution with odds of undetectable VL as outcome and as predictors: intervention, time and time\*intervention. We hypothesize that over time, the odds of undetectable VL will be higher for the intervention than the control group, which would be reflected in a significant interaction effect time\*intervention.~H0: no significant interaction effect time\*intervention"||||0.08
72473161|NCT03086655|144470121|SUPERIORITY||Mean Difference (Net)|0.16|STANDARD_ERROR_OF_MEAN|0.13|<|0.05|TWO_SIDED|95.0|-0.11|0.43||a priori threshold for statistical significance was p=0.05.|t-test, 2 sided|(equal variances assumed)|Difference = control group - treatment group|||0.43|-0.11|<0.05
72473162|NCT03086655|144470122|SUPERIORITY|||||||0.08|||||||Chi-squared|overall Wald chi2 (4 d.f.), simultaneously testing if parameters for all follow-ups by intervention are different from 0.||"statistical analyses is a GEE model with logit link function and binomial distribution with odds of optimal adherence as outcome and as predictors: intervention, time and time\*intervention. We hypothesize that over time, the odds of optimal adherence will be higher for the intervention than the control group, which would be reflected in a significant interaction effect time\*intervention.~H0: no significant interaction effect time\*intervention"||||0.08
72506881|NCT00408421|144545951|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.06|||<|0.001||95.0|0.03|0.1||P-value for Change from Baseline. Treatment effects and interaction effects were evaluated based on a two-sided significance level of 0.05. No adjustments for multiple comparisons were made. Change=Endpoint-baseline.|ANCOVA||Mean Difference = Duloxetine minus Placebo|An analysis of covariance (ANCOVA) model was used which contains the terms of treatment, NSAID use (Yes/No), the outcome score at baseline, and investigator. Type III sum-of-squares for the least-squares mean (LSMean) was used to test the null hypothesis that there is no treatment difference on the mean change from baseline to the endpoint of the outcome measure.||0.10|0.03|<0.001
72506882|NCT00408421|144545952|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.23||||0.641||95.0|-1.19|0.74||P-value for Change from Baseline. Treatment effects and interaction effects were evaluated based on a two-sided significance level of 0.05. No adjustments for multiple comparisons were made. Change=Endpoint-baseline.|ANCOVA||Mean Difference = Duloxetine minus Placebo|An analysis of covariance (ANCOVA) model was used which contains the terms of treatment, NSAID use (Yes/No), the outcome score at baseline, and investigator. Type III sum-of-squares for the least-squares mean (LSMean) was used to test the null hypothesis that there is no treatment difference on the mean change from baseline to the endpoint of the outcome measure.||0.74|-1.19|0.641
72506883|NCT00408421|144545953|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.47||||0.193||95.0|-1.17|0.24||P-value for Change from Baseline. Treatment effects and interaction effects were evaluated based on a two-sided significance level of 0.05. No adjustments for multiple comparisons were made. Change=Endpoint-baseline.|ANCOVA||Mean Difference = Duloxetine minus Placebo|An analysis of covariance (ANCOVA) model was used which contains the terms of treatment, NSAID use (Yes/No), the outcome score at baseline, and investigator. Type III sum-of-squares for the least-squares mean (LSMean) was used to test the null hypothesis that there is no treatment difference on the mean change from baseline to the endpoint of the outcome measure.||0.24|-1.17|0.193
72506884|NCT00408421|144545954|SUPERIORITY_OR_OTHER|||||||0.003||95.0||||P-value for Change from Baseline. Treatment effects and interaction effects were evaluated based on a two-sided significance level of 0.05. No adjustments for multiple comparisons were made. Change=Endpoint-baseline.|ANOVA|ANOVA on ranked data.||An analysis of variance (ANOVA) model was used which contains the terms of treatment and investigator. Rank-transformed data will be used in the analysis given the view that the change scores for most of the laboratory analytes are not normally distributed. Type III sum-of-squares for the least-squares mean (LSMean) was used to test the null hypothesis that there is no treatment difference on the mean change from baseline to the endpoint of the outcome measure.||||0.003
72565822|NCT02709486|144662707|SUPERIORITY||Least Square Mean Difference|-6.68|STANDARD_ERROR_OF_MEAN|3.67||0.0717|TWO_SIDED|95.0|-13.97|0.6|||ANCOVA|||Week 8: Percent Impairment While Working: WPAI parameters were analyzed using ANCOVA model which included covariates of the corresponding baseline score, baseline diary average pain, index joint, highest Kellgren-Lawrence grade (2, 3 or 4), and treatment, with study site as a random effect.||0.60|-13.97|0.0717
72623060|NCT02904096|144776394|OTHER|||||||0.177|||||||t-test, 1 sided|||Comparison between Group B: Hand palmar pinch strength (Left Hand)-baseline and Group B: Hand palmar pinch strength (Left Hand)-change from baseline at Month 24.||||.177
72473163|NCT05576662|144470124|OTHER||Pooled treatment coefficient|0.026||||0.903|TWO_SIDED|||||Uncorrected p-value. A p-value less than the a priori threshold of 0.05 is considered statistically significant.|Nonparametric permutation test||Weighted average of treatment coefficients. A pooled treatment coefficient \< 0 favors nirmatrelvir plus ritonavir; a pooled treatment coefficient \> 0 favors placebo plus ritonavir.|A proportional odds logistic regression model was fit for severity of each core symptom at week 10, adjusting for baseline severity of the corresponding symptom and fit using only those who experienced the symptom at baseline. A test statistic for overall efficacy was calculated as the weighted average of the treatment coefficient in the proportional odds model for each symptom with inverse variance weighting. The p-value was obtained by a nonparametric permutation test.||||0.903
72473164|NCT05576662|144470125|OTHER||Odds Ratio (OR)|1.55||||0.174|TWO_SIDED|95.0|0.82|2.94||Uncorrected p-value. A p-value less than the a priori threshold of 0.05 is considered statistically significant.|Regression, odds|Proportional odds regression coefficient Wald test|An odds ratio \< 1 favors nirmatrelvir plus ritonavir; an odds ratio \> 1 favors placebo plus ritonavir.|Analysis of fatigue score at day 15||2.94|0.82|0.174
72473165|NCT05576662|144470125|OTHER||Odds Ratio (OR)|1.21||||0.548|TWO_SIDED|95.0|0.65|2.25||Uncorrected p-value. A p-value less than the a priori threshold of 0.05 is considered statistically significant.|Regression, odds|Proportional odds regression coefficient Wald test|An odds ratio \< 1 favors nirmatrelvir plus ritonavir; an odds ratio \> 1 favors placebo plus ritonavir.|Analysis of brain fog score at day 15||2.25|0.65|0.548
72473166|NCT05576662|144470125|OTHER||Odds Ratio (OR)|0.62||||0.134|TWO_SIDED|95.0|0.33|1.16||Uncorrected p-value. A p-value less than the a priori threshold of 0.05 is considered statistically significant.|Regression, odds|Proportional odds regression coefficient Wald test|An odds ratio \< 1 favors nirmatrelvir plus ritonavir; an odds ratio \> 1 favors placebo plus ritonavir.|Analysis of dyspnea score at day 15||1.16|0.33|0.134
72398017|NCT01291173|144301962|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.93|||<|0.0001|TWO_SIDED|95.0|-7.3|-2.56|||Mixed Models Analysis|||||-2.56|-7.30|<0.0001
72398018|NCT01291173|144301963|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.15||||0.7538|TWO_SIDED|95.0|-1.11|0.8|||Mixed Models Analysis|||||0.80|-1.11|0.7538
72398019|NCT01291173|144301963|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.49||||0.3062|TWO_SIDED|95.0|-0.45|1.44|||Mixed Models Analysis|||||1.44|-0.45|0.3062
72473167|NCT05576662|144470125|OTHER||Odds Ratio (OR)|1.45||||0.241|TWO_SIDED|95.0|0.78|2.69||Uncorrected p-value. A p-value less than the a priori threshold of 0.05 is considered statistically significant.|Regression, odds|Proportional odds regression coefficient Wald test|An odds ratio \< 1 favors nirmatrelvir plus ritonavir; an odds ratio \> 1 favors placebo plus ritonavir.|Analysis of body aches score at day 15||2.69|0.78|0.241
72473168|NCT05576662|144470125|OTHER||Odds Ratio (OR)|1.03||||0.922|TWO_SIDED|95.0|0.55|1.92||Uncorrected p-value. A p-value less than the a priori threshold of 0.05 is considered statistically significant.|Regression, odds|Proportional odds regression coefficient Wald test|An odds ratio \< 1 favors nirmatrelvir plus ritonavir; an odds ratio \> 1 favors placebo plus ritonavir.|Analysis of gastrointestinal symptoms score at day 15||1.92|0.55|0.922
72473169|NCT05576662|144470125|OTHER||Odds Ratio (OR)|0.5||||0.032|TWO_SIDED|95.0|0.26|0.94||Uncorrected p-value. A p-value less than the a priori threshold of 0.05 is considered statistically significant.|Regression, odds|Proportional odds regression coefficient Wald test|An odds ratio \< 1 favors nirmatrelvir plus ritonavir; an odds ratio \> 1 favors placebo plus ritonavir.|Analysis of cardiovascular symptoms score at day 15||0.94|0.26|0.032
72473170|NCT05576662|144470126|OTHER||Odds Ratio (OR)|0.55||||0.09|TWO_SIDED|95.0|0.27|1.09||Uncorrected p-value. A p-value less than the a priori threshold of 0.05 is considered statistically significant.|Regression, Logistic|Logistic regression coefficient Wald test|An odds ratio \< 1 favors placebo plus ritonavir; an odds ratio \> 1 favors nirmatrelvir plus ritonavir.|||1.09|0.27|0.09
72473171|NCT05576662|144470127|OTHER||Odds Ratio (OR)|0.72||||0.6|TWO_SIDED|95.0|0.21|2.44||Uncorrected p-value. A p-value less than the a priori threshold of 0.05 is considered statistically significant.|Regression, Linear|Logistic regression coefficient Wald test|An odds ratio \< 1 favors placebo plus ritonavir; an odds ratio \> 1 favors nirmatrelvir plus ritonavir.|||2.44|0.21|.60
72565823|NCT02709486|144662707|SUPERIORITY||Least Square Mean Difference|-12.69|STANDARD_ERROR_OF_MEAN|3.74||0.001|TWO_SIDED|95.0|-20.11|-5.26|||ANCOVA|||Week 8: Percent Impairment While Working: WPAI parameters were analyzed using ANCOVA model which included covariates of the corresponding baseline score, baseline diary average pain, index joint, highest Kellgren-Lawrence grade (2, 3 or 4), and treatment, with study site as a random effect.||-5.26|-20.11|0.0010
72473172|NCT05576662|144470128|OTHER||Odds Ratio (OR)|1.62||||0.156|TWO_SIDED|95.0|0.83|3.15||Uncorrected p-value. A p-value less than the a priori threshold of 0.05 is considered statistically significant.|Regression, odds|Proportional odds regression coefficient Wald test|An odds ratio \< 1 favors nirmatrelvir plus ritonavir; an odds ratio \> 1 favors placebo plus ritonavir.|Analysis of severity at week 5||3.15|0.83|0.156
72473173|NCT05576662|144470128|OTHER||Odds Ratio (OR)|1.99||||0.03|TWO_SIDED|95.0|1.06|3.72||Uncorrected p-value. A p-value less than the a priori threshold of 0.05 is considered statistically significant.|Regression, odds|Proportional odds regression coefficient Wald test|An odds ratio \< 1 favors nirmatrelvir plus ritonavir; an odds ratio \> 1 favors placebo plus ritonavir.|Analysis of severity at week 10||3.72|1.06|0.03
72398020|NCT01291173|144301963|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.14||||0.7697|TWO_SIDED|95.0|-0.81|1.09|||Mixed Models Analysis|||||1.09|-0.81|0.7697
72398021|NCT01291173|144301964|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.53||||0.2046|TWO_SIDED|95.0|-0.29|1.35|||Mixed Models Analysis|||||1.35|-0.29|0.2046
72398022|NCT01291173|144301964|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.4||||0.3348|TWO_SIDED|95.0|-0.42|1.22|||Mixed Models Analysis|||||1.22|-0.42|0.3348
72398023|NCT01291173|144301964|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.81||||0.0505|TWO_SIDED|95.0|0.0|1.63|||Mixed Models Analysis|||||1.63|-0.00|0.0505
72398024|NCT01291173|144301965|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0371|TWO_SIDED|95.0|||||Mixed Models Analysis|||Cognitive Restraint of Eating||||0.0371
72398025|NCT01291173|144301965|SUPERIORITY_OR_OTHER_LEGACY|||||||0.138|TWO_SIDED|95.0|||||Mixed Models Analysis|||Cognitive Restraint of Eating||||0.1380
72398026|NCT01291173|144301965|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0459|TWO_SIDED|95.0|||||Mixed Models Analysis|||Cognitive Restraint of Eating||||0.0459
72398027|NCT01291173|144301965|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0278|TWO_SIDED|95.0|||||Mixed Models Analysis|||Disinhibition||||0.0278
72398028|NCT01291173|144301965|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0022|TWO_SIDED|95.0|||||Mixed Models Analysis|||Disinhibition||||0.0022
72398029|NCT01291173|144301965|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED|95.0|||||Mixed Models Analysis|||Disinhibition||||<0.0001
72398030|NCT01291173|144301965|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0149|TWO_SIDED|95.0|||||Mixed Models Analysis|||Hunger||||0.0149
72398031|NCT01291173|144301965|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0009|TWO_SIDED|95.0|||||Mixed Models Analysis|||Hunger||||0.0009
72398032|NCT01291173|144301965|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED|95.0|||||Mixed Models Analysis|||Hunger||||<0.0001
72398033|NCT01291173|144301966|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.9||||0.03|TWO_SIDED|95.0|-7.44|-0.38|||Mixed Models Analysis|||||-0.38|-7.44|0.030
72398034|NCT01291173|144301966|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.4||||0.002|TWO_SIDED|95.0|-8.95|-1.94|||Mixed Models Analysis|||||-1.94|-8.95|0.002
72398035|NCT01291173|144301966|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-8.5|||<|0.001|TWO_SIDED|95.0|-11.99|-4.92|||Mixed Models Analysis|||||-4.92|-11.99|<0.001
72398036|NCT01291173|144301967|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.65||||0.0824|TWO_SIDED|95.0|-5.64|0.34|||Mixed Models Analysis|||||0.34|-5.64|0.0824
72398037|NCT01291173|144301967|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.07||||0.1725|TWO_SIDED|95.0|-5.05|0.91|||Mixed Models Analysis|||||0.91|-5.05|0.1725
72398038|NCT01291173|144301967|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.71||||0.0148|TWO_SIDED|95.0|-6.69|-0.73|||Mixed Models Analysis|||||-0.73|-6.69|0.0148
72473174|NCT05576662|144470128|OTHER||Odds Ratio (OR)|2.42||||0.01|TWO_SIDED|95.0|1.27|4.6||Uncorrected p-value. A p-value less than the a priori threshold of 0.05 is considered statistically significant.|Regression, odds|Proportional odds regression coefficient Wald test|An odds ratio \< 1 favors nirmatrelvir plus ritonavir; an odds ratio \> 1 favors placebo plus ritonavir.|Analysis of severity at week 15||4.60|1.27|0.01
72473175|NCT05576662|144470129|OTHER||Hazard Ratio (HR)|0.9||||0.744|TWO_SIDED|95.0|0.45|1.77||Uncorrected p-value. A p-value less than the a priori threshold of 0.05 is considered statistically significant.|Cox PH coefficient Wald test||A hazard ratio \< 1 favors nirmatrelvir plus ritonavir; a hazard ratio \> 1 favors placebo plus ritonavir.|"Analysis of data for Time to relief - fatigue"||1.77|0.45|0.744
72506885|NCT00408421|144545955|SUPERIORITY_OR_OTHER|||||||0.026||95.0||||P-value for Change from Baseline. Treatment effects and interaction effects were evaluated based on a two-sided significance level of 0.05. No adjustments for multiple comparisons were made. Change=Endpoint-baseline.|ANOVA|ANOVA on ranked data.||An analysis of variance (ANOVA) model was used which contains the terms of treatment and investigator. Rank-transformed data will be used in the analysis given the view that the change scores for most of the laboratory analytes are not normally distributed. Type III sum-of-squares for the least-squares mean (LSMean) was used to test the null hypothesis that there is no treatment difference on the mean change from baseline to the endpoint of the outcome measure.||||0.026
72506886|NCT00408421|144545956|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.8||||0.459||95.0|-1.32|2.92||P-value for Change from Baseline. Treatment effects and interaction effects were evaluated based on a two-sided significance level of 0.05. No adjustments for multiple comparisons were made. Change=Endpoint-baseline.|ANOVA||Mean Difference = Duloxetine minus Placebo|An analysis of variance (ANOVA) model was used which contains the terms of treatment and investigator. Type III sum-of-squares for the least-squares mean (LSMean) was used to test the null hypothesis that there is no treatment difference on the mean change from baseline to the endpoint of the outcome measure.||2.92|-1.32|0.459
72506887|NCT00408421|144545957|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.09||||0.326||95.0|-1.1|3.28||P-value for Change from Baseline. Treatment effects and interaction effects were evaluated based on a two-sided significance level of 0.05. No adjustments for multiple comparisons were made. Change=Endpoint-baseline.|ANOVA||Mean Difference = Duloxetine minus Placebo|An analysis of variance (ANOVA) model was used which contains the terms of treatment and investigator. Type III sum-of-squares for the least-squares mean (LSMean) was used to test the null hypothesis that there is no treatment difference on the mean change from baseline to the endpoint of the outcome measure.||3.28|-1.10|0.326
72506888|NCT00408421|144545958|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.16||||0.069||95.0|-0.25|6.56||P-value for Change from Baseline. Treatment effects and interaction effects were evaluated based on a two-sided significance level of 0.05. No adjustments for multiple comparisons were made. Change=Endpoint-baseline.|ANOVA||Mean Difference = Duloxetine minus Placebo|An analysis of variance (ANOVA) model was used which contains the terms of treatment and investigator. Type III sum-of-squares for the least-squares mean (LSMean) was used to test the null hypothesis that there is no treatment difference on the mean change from baseline to the endpoint of the outcome measure.||6.56|-0.25|0.069
72506889|NCT00408421|144545959|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.54||||0.107||95.0|-1.2|0.12||P-value for Change from Baseline. Treatment effects and interaction effects were evaluated based on a two-sided significance level of 0.05. No adjustments for multiple comparisons were made. Change=Endpoint-baseline.|ANOVA||Mean Difference = Duloxetine minus Placebo|An analysis of variance (ANOVA) model was used which contains the terms of treatment and investigator. Type III sum-of-squares for the least-squares mean (LSMean) was used to test the null hypothesis that there is no treatment difference on the mean change from baseline to the endpoint of the outcome measure.||0.12|-1.20|0.107
72506890|NCT02772965|144545960|SUPERIORITY||Hazard Ratio (HR)|0.69||||0.08|TWO_SIDED|95.0|0.45|1.05|||Log Rank|||||1.05|0.45|0.08
72565824|NCT02709486|144662707|SUPERIORITY||Least Square Mean Difference|-10.31|STANDARD_ERROR_OF_MEAN|3.8||0.0079|TWO_SIDED|95.0|-17.85|-2.77|||ANCOVA|||Week 16: Percent Impairment While Working: WPAI parameters were analyzed using ANCOVA model which included covariates of the corresponding baseline score, baseline diary average pain, index joint, highest Kellgren-Lawrence grade (2, 3 or 4), and treatment, with study site as a random effect.||-2.77|-17.85|0.0079
72398039|NCT01291173|144301968|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.25||||0.2504|TWO_SIDED|95.0|-0.89|3.38|||Mixed Models Analysis|||Aggregate Physical Score||3.38|-0.89|0.2504
72506891|NCT02772965|144545961|SUPERIORITY||Mean Difference (Final Values)|-1.4|STANDARD_ERROR_OF_MEAN|1.4||0.32|TWO_SIDED||||||Mixed Models Analysis|||||||0.32
72506892|NCT02772965|144545962|SUPERIORITY||Mean Difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|1.8||0.69|TWO_SIDED||||||Mixed Models Analysis|||||||0.69
72398040|NCT01291173|144301968|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.09||||0.309|TWO_SIDED|95.0|-1.02|3.21|||Mixed Models Analysis|||Aggregate Physical Score||3.21|-1.02|0.3090
72473176|NCT05576662|144470129|OTHER||Hazard Ratio (HR)|0.67||||0.259|TWO_SIDED|95.0|0.32|1.37||Uncorrected p-value. A p-value less than the a priori threshold of 0.05 is considered statistically significant.|Cox PH coefficient Wald test||A hazard ratio \< 1 favors nirmatrelvir plus ritonavir; a hazard ratio \> 1 favors placebo plus ritonavir.|"Analysis of data for Time to relief - brain fog"||1.37|0.32|0.259
72473177|NCT05576662|144470129|OTHER||Hazard Ratio (HR)|1.61||||0.286|TWO_SIDED|95.0|0.65|3.99||Uncorrected p-value. A p-value less than the a priori threshold of 0.05 is considered statistically significant.|Cox PH coefficient Wald test||A hazard ratio \< 1 favors nirmatrelvir plus ritonavir; a hazard ratio \> 1 favors placebo plus ritonavir.|"Analysis of data for Time to relief - body aches"||3.99|0.65|0.286
72506893|NCT02772965|144545963|SUPERIORITY||Mean Difference (Final Values)|0.6|STANDARD_ERROR_OF_MEAN|1.6||0.72|TWO_SIDED||||||Mixed Models Analysis|||||||0.72
72565825|NCT02709486|144662707|SUPERIORITY||Least Square Mean Difference|-10.56|STANDARD_ERROR_OF_MEAN|4.0||0.0096|TWO_SIDED|95.0|-18.49|-2.63|||ANCOVA|||Week 16: Percent Impairment While Working: WPAI parameters were analyzed using ANCOVA model which included covariates of the corresponding baseline score, baseline diary average pain, index joint, highest Kellgren-Lawrence grade (2, 3 or 4), and treatment, with study site as a random effect.||-2.63|-18.49|0.0096
72398041|NCT01291173|144301968|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.5||||0.0216|TWO_SIDED|95.0|0.37|4.64|||Mixed Models Analysis|||Aggregate Physical Score||4.64|0.37|0.0216
72506894|NCT02772965|144545964|SUPERIORITY||Mean Difference (Final Values)|0.9|STANDARD_ERROR_OF_MEAN|1.9||0.64|TWO_SIDED||||||Mixed Models Analysis|||||||0.64
72506895|NCT02772965|144545965|SUPERIORITY||Risk Ratio (RR)|0.71||||0.08|TWO_SIDED|95.0|0.49|1.04|||Chi-squared|||||1.04|0.49|0.08
72506896|NCT01614769|144545975|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.41|||||TWO_SIDED|90.0|-22.98|51.8||||||||51.80|-22.98|
72506897|NCT01614769|144545975|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|35.33|||||TWO_SIDED|90.0|-2.08|72.74||||||||72.74|-2.08|
72506898|NCT01614769|144545976|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|||||TWO_SIDED|90.0|-0.21|0.0||||||||0.00|-0.21|
72506899|NCT01614769|144545976|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.13|||||TWO_SIDED|90.0|-0.24|-0.03||||||||-0.03|-0.24|
72506900|NCT01614769|144545977|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.03|||||TWO_SIDED|90.0|-11.12|1.05||||||||1.05|-11.12|
72506901|NCT01614769|144545977|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.27|||||TWO_SIDED|90.0|-13.3|-1.24||||||||-1.24|-13.30|
72506902|NCT00960440|144545984|SUPERIORITY_OR_OTHER||Percentage Difference|23.69|STANDARD_ERROR_OF_MEAN|5.73|<|0.0001|TWO_SIDED|95.0|12.45|34.92||A step-down procedure was used to control for multiple comparisons. In order for the comparison to 5 mg to be statistically significant, the comparison to 10 mg had to be statistically significant.|Normal Approximation|||Normal approximation for the difference in binomial proportions was used to test the superiority of CP-690,550 10 mg to placebo and 2-sided 95% confidence interval (CI) was evaluated for the difference in percentages.||34.92|12.45|<0.0001
72506903|NCT00960440|144545984|SUPERIORITY_OR_OTHER||Percentage Difference|17.23|STANDARD_ERROR_OF_MEAN|5.7||0.0024|TWO_SIDED|95.0|6.06|28.41||A step-down procedure was used to control for multiple comparisons. In order for the comparison to 5 mg to be statistically significant, the comparison to 10 mg had to be statistically significant.|Normal Approximation|||Normal approximation for the difference in binomial proportions was used to test the superiority of CP-690,550 5 mg to placebo and 2-sided 95% CI was evaluated for the difference in percentages.||28.41|6.06|0.0024
72506904|NCT00960440|144545985|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.28|STANDARD_ERROR_OF_MEAN|0.05|<|0.0001|TWO_SIDED|95.0|-0.38|-0.17||A step-down procedure was used to control for multiple comparisons. For the comparison of 10 mg to placebo to be statistically significant in this measure, the comparison of 10 mg to placebo in ACR20 had to be significant.|Mixed Models Analysis|||Least squares mean difference (LS Mean Difference) and corresponding 95% CI was calculated using a mixed effect repeated measure model with treatment, visit, treatment by visit interaction, and geographic region as fixed effects and participants as a random effect.||-0.17|-0.38|<0.0001
72565826|NCT02709486|144662707|SUPERIORITY||Least Square Mean Difference|-4.28|STANDARD_ERROR_OF_MEAN|4.37||0.3302|TWO_SIDED|95.0|-12.97|4.41|||ANCOVA|||Week 24: Percent Impairment While Working: WPAI parameters were analyzed using ANCOVA model which included covariates of the corresponding baseline score, baseline diary average pain, index joint, highest Kellgren-Lawrence grade (2, 3 or 4), and treatment, with study site as a random effect.||4.41|-12.97|0.3302
72398042|NCT01291173|144301968|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.07||||0.9587|TWO_SIDED|95.0|-2.75|2.9|||Mixed Models Analysis|||Aggregate Mental Score||2.90|-2.75|0.9587
72398043|NCT01291173|144301968|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.64||||0.653|TWO_SIDED|95.0|-2.17|3.45|||Mixed Models Analysis|||Aggregate Mental Score||3.45|-2.17|0.6530
72506905|NCT00960440|144545985|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.25|STANDARD_ERROR_OF_MEAN|0.05|<|0.0001|TWO_SIDED|95.0|-0.36|-0.15||Step-down procedure: For the comparison of 5 mg to placebo to be statistically significant in this measure, the comparison of 10 mg to placebo as well as the comparison of 5 mg to placebo in ACR20 had to be statistically significant.|Mixed Models Analysis|||LS Mean Difference and corresponding 95% CI was calculated using a mixed effect repeated measure model with treatment, visit, treatment by visit interaction, and geographic region as fixed effects and participants as a random effect.||-0.15|-0.36|<0.0001
72506906|NCT00960440|144545986|SUPERIORITY_OR_OTHER||Percentage Difference|9.53|STANDARD_ERROR_OF_MEAN|3.05||0.0017|TWO_SIDED|95.0|3.54|15.51||A step-down procedure was used to control for multiple comparisons. For the comparison of 10 mg to placebo to be statistically significant in this measure, the comparison of 10 mg to placebo in HAQ-DI had to be statistically significant.|Normal Approximation|||Normal approximation for the difference in binomial proportions was used to test the superiority of CP-690,550 10 mg to placebo and 2-sided 95% CI was evaluated for the difference in percentages.||15.51|3.54|0.0017
72506907|NCT00960440|144545986|SUPERIORITY_OR_OTHER||Percentage Difference|5.05|STANDARD_ERROR_OF_MEAN|2.57||0.0496|TWO_SIDED|95.0|0.0|10.1||Step-down procedure: For the comparison of 5 mg to placebo to be statistically significant in this measure, the comparison of 10 mg to placebo as well as comparison of 5 mg to placebo in HAQ-DI had to be statistically significant.|Normal Approximation|||Normal approximation for the difference in binomial proportions was used to test the superiority of CP-690,550 5 mg to placebo and 2-sided 95% CI was evaluated for the difference in percentages.||10.10|0.00|0.0496
72506908|NCT02345161|144546036|SUPERIORITY_OR_OTHER||Adjusted LS mean difference|0.171|STANDARD_ERROR_OF_MEAN|0.0118|<|0.001|TWO_SIDED|95.0|0.148|0.194|||Mixed Model Repeated Measures|||||0.194|0.148|<0.001
72506909|NCT02345161|144546037|SUPERIORITY_OR_OTHER||Adjusted LS mean difference|0.179|STANDARD_ERROR_OF_MEAN|0.0242|<|0.001|TWO_SIDED|95.0|0.131|0.226|||Mixed Model Repeated Measures|||||0.226|0.131|<0.001
72506910|NCT02345161|144546038|SUPERIORITY_OR_OTHER||Adjusted LS mean difference|-2.2|STANDARD_ERROR_OF_MEAN|0.64|<|0.001|TWO_SIDED|95.0|-3.5|-1.0|||Mixed Model Repeated Measures|||||-1.0|-3.5|<0.001
72506911|NCT02345161|144546039|SUPERIORITY_OR_OTHER||Adjusted LS mean difference|-2.7|STANDARD_ERROR_OF_MEAN|1.44||0.065|TWO_SIDED|95.0|-5.5|0.2|||Mixed Model Repeated Measures|||||0.2|-5.5|0.065
72565827|NCT02709486|144662707|SUPERIORITY||Least Square Mean Difference|-2.74|STANDARD_ERROR_OF_MEAN|4.54||0.5483|TWO_SIDED|95.0|-11.78|6.3|||ANCOVA|||Week 24: Percent Impairment While Working: WPAI parameters were analyzed using ANCOVA model which included covariates of the corresponding baseline score, baseline diary average pain, index joint, highest Kellgren-Lawrence grade (2, 3 or 4), and treatment, with study site as a random effect.||6.30|-11.78|0.5483
72398044|NCT01291173|144301968|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.03||||0.9814|TWO_SIDED|95.0|-2.79|2.86|||Mixed Models Analysis|||Aggregate Mental Score||2.86|-2.79|0.9814
72398045|NCT01506479|144301982|SUPERIORITY||Mean Difference (Final Values)|14.3|||<|0.0001|TWO_SIDED|95.0|12.0|16.6|||t-test, 2 sided|||||16.6|12.0|<0.0001
72398046|NCT01506479|144301983|OTHER||Mean Difference (Final Values)|2.9||||0.34|ONE_SIDED|90.0||4.6||The a priori threshold for statistical significance was 0.10|t-test, 1 sided|||The null hypothesis is that the vigorous exercise group warrants further investigation using a futility threshold of 3.5 compared to the control group (difference between the mean change in the control group and the mean change in the vigorous exercise group). The alternative hypothesis is that vigorous exercise does not warrant further investigation.||4.6||0.34
72506912|NCT02345161|144546040|SUPERIORITY_OR_OTHER||LS Mean difference|0.57|STANDARD_ERROR_OF_MEAN|0.138|<|0.001|TWO_SIDED|95.0|0.3|0.84|||Mixed effect repeated measures model|||||0.84|0.30|<0.001
72398047|NCT01506479|144301983|OTHER||Mean Difference (Final Values)|1.2||||0.03|ONE_SIDED|90.0||2.8||The a priori threshold for statistical significance was set to 0.10. If the p-value is less than 0.10, the null hypothesis is rejected in favor of the alternative (moderate exercise does not warrant further investigation).|t-test, 1 sided||"The estimate is the difference between the control group and the moderate exercise group.~The upper bound of the confidence interval should be compared to the futility threshold of 3.5 to reject or not reject the null hypothesis."|The null hypothesis is that the moderate exercise group warrants further investigation using a futility threshold of 3.5 compared to the control group (difference in the mean change between the control group and the moderate exercise group). The alternative hypothesis is that moderate exercise does not warrant further investigation .||2.8||0.03
72398048|NCT01506479|144301984|SUPERIORITY|||||||0.1334|||||||t-test, 2 sided|||||||0.1334
72398049|NCT00810407|144302039|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Fisher Exact|||"The factor tested was diagnosis. The null hypothesis was that there was no association between diagnosis and the number of participants with treatment-related adverse events."||||<0.001
72398050|NCT00810407|144302040|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Fisher Exact|||"The factor tested was gender. The null hypothesis was that there was no association between gender and the number of participants with treatment-related adverse events."||||<0.001
72398051|NCT00810407|144302041|SUPERIORITY_OR_OTHER|||||||0.587|||||||Fisher Exact|||"The factor tested was age. The null hypothesis was that there was no association between age of participants and the number of participants with treatment-related adverse events."||||0.587
72398052|NCT00810407|144302041|SUPERIORITY_OR_OTHER|||||||0.428|||||||Cochran-Armitage (EXACT)|||"The factor tested was age. The null hypothesis was that there was no ordinal trend in the number of participants with treatment-related adverse events across the age at baseline."||||0.428
72398053|NCT03108027|144302049|OTHER|A hypothesis test is not planned for this study, inferences are to be performed by interpreting confidence interval of treatment difference.'|Mean Difference (Net)|0.6096|||||TWO_SIDED|90.0|0.538|0.6811|||Mixed Models Analysis|||||0.6811|0.5380|
72398054|NCT03108027|144302049|OTHER|A hypothesis test is not planned for this study, inferences are to be performed by interpreting confidence interval of treatment difference.'|Mean Difference (Net)|0.6152|||||TWO_SIDED|90.0|0.5437|0.6868|||Mixed Models Analysis|||||0.6868|0.5437|
72398055|NCT03108027|144302049|OTHER|A hypothesis test is not planned for this study, inferences are to be performed by interpreting confidence interval of treatment difference.'|Mean Difference (Net)|-0.0057|||||TWO_SIDED|90.0|-0.076|0.0647|||Mixed Models Analysis|||||0.0647|-0.0760|
72398056|NCT03108027|144302050|OTHER|A hypothesis test is not planned for this study, inferences are to be performed by interpreting confidence interval of treatment difference.'|Mean Difference (Net)|0.6206|||||TWO_SIDED|90.0|0.5335|0.7077|||Mixed Models Analysis|||||0.7077|0.5335|
72398057|NCT03108027|144302050|OTHER|A hypothesis test is not planned for this study, inferences are to be performed by interpreting confidence interval of treatment difference.'|Mean Difference (Net)|0.7347|||||TWO_SIDED|90.0|0.6469|0.8225|||Mixed Models Analysis|||||0.8225|0.6469|
72398058|NCT03108027|144302050|OTHER|A hypothesis test is not planned for this study, inferences are to be performed by interpreting confidence interval of treatment difference.'|Mean Difference (Net)|-0.1141|||||TWO_SIDED|90.0|-0.197|-0.0311|||Mixed Models Analysis|||||-0.0311|-0.1970|
72398059|NCT03108027|144302051|OTHER|A hypothesis test is not planned for this study, inferences are to be performed by interpreting confidence interval of treatment difference.'|Mean Difference (Net)|72.1|||||TWO_SIDED|90.0|61.3|82.9|||Mixed Models Analysis|||Morning average PEF||82.9|61.3|
72398060|NCT03108027|144302051|OTHER|A hypothesis test is not planned for this study, inferences are to be performed by interpreting confidence interval of treatment difference.'|Mean Difference (Net)|86.9|||||TWO_SIDED|90.0|76.1|97.8|||Mixed Models Analysis|||Morning average PEF||97.8|76.1|
72398061|NCT03108027|144302051|OTHER|A hypothesis test is not planned for this study, inferences are to be performed by interpreting confidence interval of treatment difference.'|Mean Difference (Net)|-14.8|||||TWO_SIDED|90.0|-25.6|-4.1|||Mixed Models Analysis|||Morning average PEF||-4.1|-25.6|
72398062|NCT03108027|144302051|OTHER|A hypothesis test is not planned for this study, inferences are to be performed by interpreting confidence interval of treatment difference.'|Mean Difference (Net)|73.1|||||TWO_SIDED|90.0|61.9|84.2|||Mixed Models Analysis|||Evening average PEF||84.2|61.9|
72398063|NCT03108027|144302051|OTHER|A hypothesis test is not planned for this study, inferences are to be performed by interpreting confidence interval of treatment difference.'|Mean Difference (Net)|58.7||||||90.0|47.5|69.9|||Mixed Models Analysis|||Evening average PEF||69.9|47.5|
72398064|NCT03108027|144302051|OTHER|A hypothesis test is not planned for this study, inferences are to be performed by interpreting confidence interval of treatment difference.'|Mean Difference (Net)|14.4|||||TWO_SIDED|90.0|3.3|25.5|||Mixed Models Analysis|||Evening average PEF||25.5|3.3|
72398065|NCT02574247|144302059|OTHER|||||||0.34|||||||Spearman partial rank correlation|Age and high-frequency pure-tone average controlled for.||Statistical analysis for the row CRM at -9 dB SNR||||0.34
72506913|NCT02345161|144546041|SUPERIORITY_OR_OTHER||LS Mean difference|0.34|STANDARD_ERROR_OF_MEAN|0.317||0.279|TWO_SIDED|95.0|-0.28|0.97|||Mixed effect repeated measures model|||||0.97|-0.28|0.279
72506914|NCT02345161|144546042|SUPERIORITY_OR_OTHER||LS Mean difference|0.1|STANDARD_ERROR_OF_MEAN|0.51||0.817|TWO_SIDED|95.0|-0.9|1.1|||ANCOVA|||||1.1|-0.9|0.817
72506915|NCT02345161|144546043|SUPERIORITY_OR_OTHER||LS Mean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.95||0.767|TWO_SIDED|95.0|-2.1|1.6|||ANCOVA|||||1.6|-2.1|0.767
72506916|NCT02345161|144546044|SUPERIORITY_OR_OTHER||Rate ratio|0.65||||0.002|TWO_SIDED|95.0|0.49|0.86|||Generalized linear modeL|Generalized linear model assuming a negative binomial distribution||||0.86|0.49|0.002
72398066|NCT02574247|144302059|OTHER|||||||0.64|||||||Spearman partial rank correlation|Age and high-frequency pure-tone average controlled for.||Statistical analysis for the row CRM at -6 dB SNR||||0.64
72398067|NCT02574247|144302059|OTHER|||||||0.24|||||||Spearman partial rank correlation|Age and high-frequency average controlled for.||Statistical analysis for the row IEEE at -6 dB SNR||||0.24
72398068|NCT02574247|144302059|OTHER|||||||0.2|||||||Spearman partial rank correlation|Age and high-frequency average controlled for.||Statistical analysis for the row IEEE at -3 dB SNR||||0.20
72398069|NCT02574247|144302062|OTHER|||||||0.03|||||||Spearman partial rank correlation|Age and high-frequency pure-tone average controlled for.||Statistical analysis for the row CRM slope||||0.03
72398070|NCT02574247|144302062|OTHER|||||||0.04|||||||Spearman partial rank correlation|Age and high-frequency pure-tone average controlled for.||Statistical analysis for row IEEE slope||||0.04
72398071|NCT00268996|144302063|SUPERIORITY_OR_OTHER||Adjusted percentage change|-11.717||||0.348|TWO_SIDED|95.0|-31.995|14.607|||ANCOVA||Adjusted percentage change is shown \[(Darapladib 160 mg EC tablet /Placebo) - 1 multiplied by 100\]|||14.607|-31.995|0.348
72398072|NCT00268996|144302064|SUPERIORITY_OR_OTHER||Adjusted Treatment Difference|-0.082||||0.22|TWO_SIDED|95.0|-0.214|0.049|||ANCOVA||Difference in adjusted means is shown (Darapladib 160 mg EC tablet - Placebo).|||0.049|-0.214|0.220
72398073|NCT00268996|144302065|SUPERIORITY_OR_OTHER||Adjusted percentage change|3.977||||0.751|TWO_SIDED|95.0|-18.331|32.379|||ANCOVA||Adjusted percentage change is shown \[(Darapladib 160 mg EC tablet /Placebo) - 1 multiplied by 100\]|||32.379|-18.331|0.751
72398074|NCT00268996|144302066|SUPERIORITY_OR_OTHER||Adjusted percentage change|-60.737|||<|0.001|TWO_SIDED|95.0|-63.486|-57.78|||ANCOVA||Adjusted percentage change is shown \[(Darapladib 160 mg EC tablet /Placebo) - 1 multiplied by 100\]|Placebo vs Darapladib 160 mg EC tablet at Week 26 (LOCF)||-57.780|-63.486|<0.001
72398075|NCT00268996|144302066|SUPERIORITY_OR_OTHER||Adjusted percentage change|-59.326|||<|0.001|TWO_SIDED|95.0|-62.21|-56.222|||ANCOVA||Adjusted percentage change is shown \[(Darapladib 160 mg EC tablet /Placebo) - 1 multiplied by 100\]|Placebo vs Darapladib 160 mg EC tablet at Week 52 (LOCF)||-56.222|-62.210|<0.001
72398076|NCT00268996|144302067|SUPERIORITY_OR_OTHER||Adjusted Treatment Difference|0.253||||0.945|TWO_SIDED|95.0|-6.998|7.504|||ANCOVA||Difference in adjusted means are shown (Darapladib 160 mg EC tablet - Placebo).|||7.504|-6.998|0.945
72398077|NCT00268996|144302068|SUPERIORITY_OR_OTHER||Difference in adjusted means|-0.062||||0.898|TWO_SIDED|95.0|-1.009|0.886|||ANCOVA||Difference in adjusted means are shown (Darapladib 160 mg EC tablet - Placebo).|||0.886|-1.009|0.898
72398078|NCT00268996|144302069|SUPERIORITY_OR_OTHER||Difference in adjusted means|-5.165||||0.012|TWO_SIDED|95.0|-9.185|-1.145|||ANCOVA||Difference in adjusted means are shown (Darapladib 160 mg EC tablet - Placebo).|||-1.145|-9.185|0.012
72398079|NCT00268996|144302070|SUPERIORITY_OR_OTHER||Difference in adjusted means|-1.967||||0.047|TWO_SIDED|95.0|-3.912|-0.022|||ANCOVA||Difference in adjusted means are shown (Darapladib 160 mg EC tablet - Placebo).|||-0.022|-3.912|0.047
72398080|NCT00268996|144302071|SUPERIORITY_OR_OTHER||Adjusted percentage change|6.958||||0.487|TWO_SIDED|95.0|-11.568|29.364|||ANCOVA||Adjusted percentage change is shown \[(Darapladib 160 mg EC tablet /Placebo) - 1 multiplied by 100\]|Week 26 (LOCF): Comparison between Placebo vs Darapladib 160 mg EC tablet||29.364|-11.568|0.487
72398081|NCT00268996|144302071|SUPERIORITY_OR_OTHER||Adjusted percentage change|12.255||||0.247|TWO_SIDED|95.0|-7.725|36.562|||ANCOVA||Adjusted percentage change is shown \[(Darapladib 160 mg EC tablet /Placebo) - 1 multiplied by 100\]|Week 52 (LOCF): Comparison between Placebo Vs Darapladib 160 mg EC tablet||36.562|-7.725|0.247
72398082|NCT00268996|144302072|SUPERIORITY_OR_OTHER||Adjusted percentage change|-1.112||||0.687|TWO_SIDED|95.0|-6.363|4.433|||ANCOVA||Adjusted percentage change is shown \[(Darapladib 160 mg EC tablet once daily/Placebo) - 1 multiplied by 100\]|Placebo vs Darapladib 160 mg EC tablet once daily at Week 26 (LOCF)||4.433|-6.363|0.687
72398083|NCT00268996|144302072|SUPERIORITY_OR_OTHER||Adjusted percentage change|-3.237||||0.29|TWO_SIDED|95.0|-8.976|2.865|||ANOVA||Adjusted percentage change is shown \[(Darapladib 160 mg EC tablet once daily/Placebo) - 1 multiplied by 100\]|||2.865|-8.976|0.290
72398084|NCT00268996|144302073|SUPERIORITY_OR_OTHER||Adjusted percentage change|16.725||||0.022|TWO_SIDED|95.0|2.232|33.271|||ANCOVA||Adjusted percentage change is shown \[(Darapladib 160 mg EC tablet once daily/Placebo) - 1 multiplied by 100\]|Placebo vs Darapladib 160 mg EC tablet once daily at Week 26 (LOCF)||33.271|2.232|0.022
72398085|NCT00268996|144302073|SUPERIORITY_OR_OTHER||Adjusted percentage change|9.256||||0.252|TWO_SIDED|95.0|-6.136|27.172|||ANCOVA||Adjusted percentage change is shown \[(Darapladib 160 mg EC tablet once daily/Placebo) - 1 multiplied by 100\]|Placebo vs Darapladib 160 mg EC tablet once daily at Week 52 (LOCF)||27.172|-6.136|0.252
72398086|NCT00268996|144302074|SUPERIORITY_OR_OTHER||Adjusted percentage change|15.449||||0.196|TWO_SIDED|95.0|-7.204|43.632|||ANCOVA||Adjusted percentage change is shown \[(Darapladib 160 mg EC tablet once daily/Placebo) - 1 multiplied by 100\]|Placebo vs Darapladib 160 mg EC tablet once daily at Week 26||43.632|-7.204|0.196
72506917|NCT02345161|144546045|SUPERIORITY_OR_OTHER||Rate ratio|0.56||||0.006|TWO_SIDED|95.0|0.37|0.85|||Generalized Linear model|Generalized linear model assuming a negative binomial distribution||||0.85|0.37|0.006
72398087|NCT00268996|144302074|SUPERIORITY_OR_OTHER||Adjusted percentage change|38.567||||0.024|TWO_SIDED|95.0|4.355|83.997|||ANCOVA||Adjusted percentage change is shown \[(Darapladib 160 mg EC tablet once daily/Placebo) - 1 multiplied by 100\]|Placebo vs Darapladib 160 mg EC tablet once daily at Week 52||83.997|4.355|0.024
72398088|NCT00268996|144302075|SUPERIORITY_OR_OTHER||Adjusted percentage change|-2.098||||0.79|TWO_SIDED|95.0|-16.303|14.517|||ANCOVA||Adjusted percentage change is shown \[(Darapladib 160 mg EC tablet once daily/Placebo) - 1 multiplied by 100\]|Placebo vs Darapladib 160 mg EC tablet once daily at Week 26 (LOCF)||14.517|-16.303|0.790
72506918|NCT02345161|144546046|SUPERIORITY_OR_OTHER||LS Mean difference|-0.95|STANDARD_ERROR_OF_MEAN|0.15|<|0.001|TWO_SIDED|95.0|-1.25|-0.66|||Mixed Model Repeated Measures||EXACT-RS Scores, Week 1-4|||-0.66|-1.25|<0.001
72506919|NCT02345161|144546046|SUPERIORITY_OR_OTHER||LS Mean difference|-1.23|STANDARD_ERROR_OF_MEAN|0.183|<|0.001|TWO_SIDED|95.0|-1.59|-0.87|||Mixed Model Repeated Measures||EXACT-RS Scores, Week 5-8|||-0.87|-1.59|<0.001
72506920|NCT02345161|144546046|SUPERIORITY_OR_OTHER||LS Mean difference|-1.18|STANDARD_ERROR_OF_MEAN|0.201|<|0.001|TWO_SIDED|95.0|-1.57|-0.78|||Mixed Model Repeated Measures||EXACT-RS Scores, Week 9-12|||-0.78|-1.57|<0.001
72506921|NCT02345161|144546046|SUPERIORITY_OR_OTHER||LS Mean difference|-1.33|STANDARD_ERROR_OF_MEAN|0.213|<|0.001|TWO_SIDED|95.0|-1.75|-0.91|||Mixed Model Repeated Measures||EXACT-RS Scores, Week 13-16|||-0.91|-1.75|<0.001
72473178|NCT05576662|144470129|OTHER||Hazard Ratio (HR)|0.92||||0.846|TWO_SIDED|95.0|0.38|2.24||Uncorrected p-value. A p-value less than the a priori threshold of 0.05 is considered statistically significant.|Cox PH coefficient Wald test||A hazard ratio \< 1 favors nirmatrelvir plus ritonavir; a hazard ratio \> 1 favors placebo plus ritonavir.|"Analysis of data for Time to relief - cardiovascular symptoms"||2.24|0.38|0.846
72473179|NCT05576662|144470129|OTHER||Hazard Ratio (HR)|1.56||||0.41|TWO_SIDED|95.0|0.51|4.73||Uncorrected p-value. A p-value less than the a priori threshold of 0.05 is considered statistically significant.|Cox PH coefficient Wald test|A hazard ratio \< 1 favors nirmatrelvir plus ritonavir; a hazard ratio \> 1 favors placebo plus ritonavir.||"Analysis of data for Time to relief - shortness of breath"||4.73|0.51|0.410
72473180|NCT05576662|144470129|OTHER||Hazard Ratio (HR)|0.94||||0.88|TWO_SIDED|95.0|0.42|2.11||Uncorrected p-value. A p-value less than the a priori threshold of 0.05 is considered statistically significant.|Cox PH coefficient Wald test||A hazard ratio \< 1 favors nirmatrelvir plus ritonavir; a hazard ratio \> 1 favors placebo plus ritonavir.|"Analysis of data for Time to relief - gastrointestinal symptoms"||2.11|0.42|0.880
72473181|NCT05576662|144470130|OTHER||Hazard Ratio (HR)|0.74||||0.33|TWO_SIDED|95.0|0.4|1.38||Uncorrected p-value. A p-value less than the a priori threshold of 0.05 is considered statistically significant.|Cox PH coefficient Wald test||A hazard ratio \< 1 favors nirmatrelvir plus ritonavir; a hazard ratio \> 1 favors placebo plus ritonavir.|||1.38|0.40|0.33
72473182|NCT05576662|144470131|OTHER||Mean Difference (Net)|0.57||||0.66|TWO_SIDED|95.0|-1.96|3.1||Uncorrected p-value. A p-value less than the a priori threshold of 0.05 is considered statistically significant.|Regression, Linear|Linear regression coefficient Wald test|A mean difference \< 0 favors placebo plus ritonavir; a mean difference \> 0 favors nirmatrelvir plus ritonavir.|||3.10|-1.96|.66
72506922|NCT02345161|144546046|SUPERIORITY_OR_OTHER||LS Mean difference|-1.41|STANDARD_ERROR_OF_MEAN|0.223|<|0.001|TWO_SIDED|95.0|-1.85|-0.97|||Mixed Model Repeated Measures||EXACT-RS Scores, Week 17-20|||-0.97|-1.85|<0.001
72398089|NCT00268996|144302075|SUPERIORITY_OR_OTHER||Adjusted percentage change|1.986||||0.818|TWO_SIDED|95.0|-13.807|20.673|||ANCOVA||Adjusted percentage change is shown \[(Darapladib 160 mg EC tablet once daily/Placebo) - 1 multiplied by 100\]|Placebo vs Darapladib 160 mg EC tablet once daily at Week 52 (LOCF)||20.673|-13.807|0.818
72398090|NCT00268996|144302076|SUPERIORITY_OR_OTHER||Adjusted percentage change|-0.252||||0.98|TWO_SIDED|95.0|-18.151|21.561|||ANCOVA||Adjusted percentage change is shown \[(Darapladib 160 mg EC tablet once daily/Placebo) - 1 multiplied by 100\]|Placebo vs Darapladib 160 mg EC tablet once daily at Week 26 (LOCF)||21.561|-18.151|0.980
72398091|NCT00268996|144302076|SUPERIORITY_OR_OTHER||Adjusted percentage change|-8.585||||0.663|TWO_SIDED|95.0|-39.007|37.012|||ANCOVA||Adjusted percentage change is shown \[(Darapladib 160 mg EC tablet once daily/Placebo) - 1 multiplied by 100\]|Placebo vs Darapladib 160 mg EC tablet once daily at Week 52 (LOCF)||37.012|-39.007|0.663
72473183|NCT05576662|144470132|OTHER||Mean Difference (Net)|0.38||||0.79|TWO_SIDED|95.0|-2.4|3.15||Uncorrected p-value. A p-value less than the a priori threshold of 0.05 is considered statistically significant.|Regression, Linear|Linear regression coefficient Wald test|A mean difference \< 0 favors nirmatrelvir plus ritonavir; a mean difference \> 0 favors placebo plus ritonavir.|||3.15|-2.40|0.79
72473184|NCT05576662|144470133|OTHER||Mean Difference (Net)|0.6||||0.7|TWO_SIDED|95.0|-2.55|3.75||Uncorrected p-value. A p-value less than the a priori threshold of 0.05 is considered statistically significant.|Regression, Linear|Linear regression coefficient Wald test|A mean difference \< 0 favors nirmatrelvir plus ritonavir; a mean difference \> 0 favors placebo plus ritonavir.|||3.75|-2.55|.70
72473185|NCT05576662|144470134|OTHER||Mean Difference (Net)|0.03||||0.98|TWO_SIDED|95.0|-3.21|3.28||Uncorrected p-value. A p-value less than the a priori threshold of 0.05 is considered statistically significant.|Regression, Linear|Linear regression coefficient Wald test|A mean difference \< 0 favors placebo plus ritonavir; a mean difference \> 0 favors nirmatrelvir plus ritonavir.|||3.28|-3.21|.98
72473186|NCT05576662|144470135|OTHER||Mean Difference (Net)|1.73||||0.555|TWO_SIDED|95.0|-4.06|7.53||Uncorrected p-value. A p-value less than the a priori threshold of 0.05 is considered statistically significant.|Regression, Linear|Linear regression coefficient Wald test|A mean difference \< 0 favors nirmatrelvir plus ritonavir; a mean difference \> 0 favors placebo plus ritonavir.|Analysis of data for change of systolic blood pressure||7.53|-4.06|0.555
72473187|NCT05576662|144470135|OTHER||Mean Difference (Net)|-0.68||||0.764|TWO_SIDED|95.0|-5.15|3.79||Uncorrected p-value. A p-value less than the a priori threshold of 0.05 is considered statistically significant.|Regression, Linear|Linear regression coefficient Wald test|A mean difference \< 0 favors nirmatrelvir plus ritonavir; a mean difference \> 0 favors placebo plus ritonavir.|Analysis of data for change of diastolic blood pressure||3.79|-5.15|0.764
72473188|NCT05576662|144470136|OTHER||Mean Difference (Net)|-0.51||||0.856|TWO_SIDED|95.0|-6.15|5.12||Uncorrected p-value. A p-value less than the a priori threshold of 0.05 is considered statistically significant.|Regression, Linear|Linear regression coefficient Wald test|A mean difference \< 0 favors nirmatrelvir plus ritonavir; a mean difference \> 0 favors placebo plus ritonavir.|||5.12|-6.15|0.856
72473189|NCT05576662|144470137|OTHER||Mean Difference (Net)|-0.41||||0.833|TWO_SIDED|95.0|-4.24|3.42||Uncorrected p-value. A p-value less than the a priori threshold of 0.05 is considered statistically significant.|Regression, Linear|Linear regression coefficient Wald test|A mean difference \< 0 favors placebo plus ritonavir; a mean difference \> 0 favors nirmatrelvir plus ritonavir.|||3.42|-4.24|0.833
72473190|NCT05576662|144470138|OTHER||Mean Difference (Final Values)|0.32||||0.096|TWO_SIDED|95.0|-0.06|0.7||Uncorrected p-value. A p-value less than the a priori threshold of 0.05 is considered statistically significant.|Regression, Linear|Linear regression coefficient Wald test|A mean difference \< 0 favors nirmatrelvir plus ritonavir; a mean difference \> 0 favors placebo plus ritonavir.|Analysis of day 15 data||0.70|-0.06|0.096
72506923|NCT02345161|144546046|SUPERIORITY_OR_OTHER||Mixed Model Repeated Measures|-1.35|STANDARD_ERROR_OF_MEAN|0.224|<|0.001|TWO_SIDED|95.0|-1.79|-0.91|||Mixed Model Repeated Measures||EXACT-RS Scores, Week 21-24|||-0.91|-1.79|<0.001
72506924|NCT02345161|144546046|SUPERIORITY_OR_OTHER||LS Mean difference|-0.52|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-0.67|-0.36|||Mixed Model Repeated Measures||Breathlessness EXACT-RS Score, Week 1-4|||-0.36|-0.67|<0.001
72506925|NCT02345161|144546046|SUPERIORITY_OR_OTHER||LS Mean difference|-0.69|STANDARD_ERROR_OF_MEAN|0.098|<|0.001|TWO_SIDED|95.0|-0.88|-0.5|||Mixed Model Repeated Measures||Breathlessness EXACT-RS Score, Week 5-8|||-0.50|-0.88|<0.001
72473191|NCT05576662|144470138|OTHER||Mean Difference (Final Values)|0.22||||0.293|TWO_SIDED|95.0|-0.2|0.64||Uncorrected p-value. A p-value less than the a priori threshold of 0.05 is considered statistically significant.|Regression, Linear|Linear regression coefficient Wald test|A mean difference \< 0 favors nirmatrelvir plus ritonavir; a mean difference \> 0 favors placebo plus ritonavir.|Analysis of week 5 data||0.64|-0.20|0.293
72473192|NCT05576662|144470138|OTHER||Mean Difference (Final Values)|0.19||||0.396|TWO_SIDED|95.0|-0.25|0.62||Uncorrected p-value. A p-value less than the a priori threshold of 0.05 is considered statistically significant.|Regression, Linear|Linear regression coefficient Wald test|A mean difference \< 0 favors nirmatrelvir plus ritonavir; a mean difference \> 0 favors placebo plus ritonavir.|Analysis of week 10 data||0.62|-0.25|0.396
72473193|NCT05576662|144470138|OTHER||Mean Difference (Final Values)|0.37||||0.064|TWO_SIDED|95.0|-0.02|0.77||Uncorrected p-value. A p-value less than the a priori threshold of 0.05 is considered statistically significant.|Regression, Linear|Linear regression coefficient Wald test|A mean difference \< 0 favors nirmatrelvir plus ritonavir; a mean difference \> 0 favors placebo plus ritonavir.|Analysis of week 15 data||0.77|-0.02|0.064
72473194|NCT05576662|144470139|OTHER||Mean Difference (Final Values)|0.19||||0.444|TWO_SIDED|95.0|-0.3|0.67||Uncorrected p-value. A p-value less than the a priori threshold of 0.05 is considered statistically significant.|Regression, Linear|Linear regression coefficient Wald test|A mean difference \< 0 favors nirmatrelvir plus ritonavir; a mean difference \> 0 favors placebo plus ritonavir.|Analysis of day 15 data||0.67|-0.30|0.444
72473195|NCT05576662|144470139|OTHER||Mean Difference (Final Values)|-0.25||||0.346|TWO_SIDED|95.0|-0.78|0.28||Uncorrected p-value. A p-value less than the a priori threshold of 0.05 is considered statistically significant.|Regression, Linear|Linear regression coefficient Wald test|A mean difference \< 0 favors nirmatrelvir plus ritonavir; a mean difference \> 0 favors placebo plus ritonavir.|Analysis of week 5 data||0.28|-0.78|0.346
72473196|NCT05576662|144470139|OTHER||Mean Difference (Final Values)|0.1||||0.738|TWO_SIDED|95.0|-0.48|0.67||Uncorrected p-value. A p-value less than the a priori threshold of 0.05 is considered statistically significant.|Regression, Linear|Linear regression coefficient Wald test|A mean difference \< 0 favors nirmatrelvir plus ritonavir; a mean difference \> 0 favors placebo plus ritonavir.|Analysis of week 10 data||0.67|-0.48|0.738
72506926|NCT02345161|144546046|SUPERIORITY_OR_OTHER||LS Mean difference|-0.69|STANDARD_ERROR_OF_MEAN|0.108|<|0.001|TWO_SIDED|95.0|-0.9|-0.48|||Mixed Model Repeated Measures||Breathlessness EXACT-RS Score, Week 9-12|||-0.48|-0.90|<0.001
72398092|NCT00268996|144302078|SUPERIORITY_OR_OTHER||Adjusted treatment Difference|1.758||||0.811|TWO_SIDED|95.0|-12.675|16.192|||ANCOVA||Difference in adjusted means are shown (Darapladib 160mg EC tablet once daily - Placebo).|For vessel volume||16.192|-12.675|0.811
72473197|NCT05576662|144470139|OTHER||Mean Difference (Final Values)|0.17||||0.578|TWO_SIDED|95.0|-0.43|0.76||Uncorrected p-value. A p-value less than the a priori threshold of 0.05 is considered statistically significant.|Regression, Linear|Linear regression coefficient Wald test|A mean difference \< 0 favors nirmatrelvir plus ritonavir; a mean difference \> 0 favors placebo plus ritonavir.|Analysis of week 15 data||0.76|-0.43|0.578
72473198|NCT05576662|144470140|OTHER||Mean Difference (Final Values)|-0.19||||0.758|TWO_SIDED|95.0|-1.41|1.03||Uncorrected p-value. A p-value less than the a priori threshold of 0.05 is considered statistically significant.|Regression, Linear|Linear regression coefficient Wald test|A mean difference \< 0 favors nirmatrelvir plus ritonavir; a mean difference \> 0 favors placebo plus ritonavir.|Analysis of week 5 data||1.03|-1.41|0.758
72473199|NCT05576662|144470140|OTHER||Mean Difference (Final Values)|-0.24||||0.693|TWO_SIDED|95.0|-1.46|0.97||Uncorrected p-value. A p-value less than the a priori threshold of 0.05 is considered statistically significant.|Regression, Linear|Linear regression coefficient Wald test|A mean difference \< 0 favors nirmatrelvir plus ritonavir; a mean difference \> 0 favors placebo plus ritonavir.|Analysis of week 10 data||0.97|-1.46|0.693
72473200|NCT05576662|144470140|OTHER||Mean Difference (Final Values)|0.37||||0.558|TWO_SIDED|95.0|-0.87|1.61||Uncorrected p-value. A p-value less than the a priori threshold of 0.05 is considered statistically significant.|Regression, Linear|Linear regression coefficient Wald test|A mean difference \< 0 favors nirmatrelvir plus ritonavir; a mean difference \> 0 favors placebo plus ritonavir.|Analysis of week 15 data||1.61|-0.87|0.558
72473201|NCT05576662|144470141|OTHER||Odds Ratio (OR)|0.55||||0.02|TWO_SIDED|95.0|0.33|0.92||Uncorrected p-value. A p-value less than the a priori threshold of 0.05 is considered statistically significant.|Regression, Logistic|Logistic regression coefficient Wald test|An odds ratio \< 1 favors placebo plus ritonavir; an odds ratio \> 1 favors nirmatrelvir plus ritonavir.|Post-hoc analysis of fatigue data||0.92|0.33|0.02
72473202|NCT05576662|144470141|OTHER||Odds Ratio (OR)|0.5||||0.01|TWO_SIDED|95.0|0.31|0.82||Uncorrected p-value. A p-value less than the a priori threshold of 0.05 is considered statistically significant.|Regression, Logistic|Logistic regression coefficient Wald test|An odds ratio \< 1 favors placebo plus ritonavir; an odds ratio \> 1 favors nirmatrelvir plus ritonavir.|Post-hoc analysis of brain fog data||0.82|0.31|0.01
72473203|NCT05576662|144470141|OTHER||Odds Ratio (OR)|1.32||||0.34|TWO_SIDED|95.0|0.74|2.33||Uncorrected p-value. A p-value less than the a priori threshold of 0.05 is considered statistically significant.|Regression, Logistic|Logistic regression coefficient Wald test|An odds ratio \< 1 favors placebo plus ritonavir; an odds ratio \> 1 favors nirmatrelvir plus ritonavir.|Post-hoc analysis of body aches data||2.33|0.74|0.34
72473204|NCT05576662|144470141|OTHER||Odds Ratio (OR)|1.37||||0.29|TWO_SIDED|95.0|0.76|2.48||Uncorrected p-value. A p-value less than the a priori threshold of 0.05 is considered statistically significant.|Regression, Logistic|Logistic regression coefficient Wald test|An odds ratio \< 1 favors placebo plus ritonavir; an odds ratio \> 1 favors nirmatrelvir plus ritonavir.|Post-hoc analysis of cardiovascular symptoms data||2.48|0.76|0.29
72473205|NCT05576662|144470141|OTHER||Odds Ratio (OR)|1.32||||0.35|TWO_SIDED|95.0|0.73|2.38||Uncorrected p-value. A p-value less than the a priori threshold of 0.05 is considered statistically significant.|Regression, Logistic|Logistic regression coefficient Wald test|An odds ratio \< 1 favors placebo plus ritonavir; an odds ratio \> 1 favors nirmatrelvir plus ritonavir.|Post-hoc analysis of shortness of breath data||2.38|0.73|0.35
72506927|NCT02345161|144546046|SUPERIORITY_OR_OTHER||LS Mean difference|-0.75|STANDARD_ERROR_OF_MEAN|0.115|<|0.001|TWO_SIDED|95.0|-0.97|-0.52|||Mixed Model Repeated Measures||Breathlessness EXACT-RS Score, Week 13-16|||-0.52|-0.97|<0.001
72506928|NCT02345161|144546046|SUPERIORITY_OR_OTHER||LS Mean difference|-0.79|STANDARD_ERROR_OF_MEAN|0.12|<|0.001|TWO_SIDED|95.0|-1.03|-0.56|||Mixed Model Repeated Measures||Breathlessness EXACT-RS Score, Week 17-20|||-0.56|-1.03|<0.001
72398093|NCT00268996|144302078|SUPERIORITY_OR_OTHER||Adjusted Treatment Difference|2.627||||0.708|TWO_SIDED|95.0|-11.171|16.425|||ANCOVA||Difference in adjusted means are shown (Darapladib 160 mg EC tablet once daily - Placebo).|For lumen volume||16.425|-11.171|0.708
72398094|NCT00268996|144302079|SUPERIORITY_OR_OTHER||Adjusted Treatment Difference|-0.012||||0.873|TWO_SIDED|95.0|-0.16|0.136||Data analyzed using ANCOVA, with ACS status, pooled country, baseline value , matched segment length and treatment included as covariates.|ANCOVA||Difference in adjusted means are shown (Darapladib 160 mg EC tablet one daily - Placebo).|Placebo vs Darapladib 160 mg EC tablet: Mean vessel area||0.136|-0.160|0.873
72398095|NCT00268996|144302079|SUPERIORITY_OR_OTHER||Adjusted Treatment Difference|0.048||||0.756|TWO_SIDED|95.0|-0.258|0.354|||ANCOVA|Data analyzed using ANCOVA, with ACS status, pooled country, baseline value , matched segment length and treatment included as covariates.|Difference in adjusted means are shown (Darapladib 160 mg EC tablet one daily - Placebo).|Placebo vs Darapladib 160 mg EC tablet: Mean vessel area||0.354|-0.258|0.756
72398096|NCT00268996|144302079|SUPERIORITY_OR_OTHER||Adjusted Treatment Difference|0.061||||0.687|TWO_SIDED|95.0|-0.237|0.36|||ANCOVA|Data analyzed using ANCOVA, with ACS status, pooled country, baseline value , matched segment length and treatment included as covariates.|Difference in adjusted means are shown (Darapladib 160 mg EC tablet one daily - Placebo).|Placebo vs Darapladib 160 mg EC tablet: Mean lumen area||0.360|-0.237|0.687
72473206|NCT05576662|144470141|OTHER||Odds Ratio (OR)|1.4||||0.25|TWO_SIDED|95.0|0.79|2.47||Uncorrected p-value. A p-value less than the a priori threshold of 0.05 is considered statistically significant.|Regression, Logistic|Logistic regression coefficient Wald test|An odds ratio \< 1 favors placebo plus ritonavir; an odds ratio \> 1 favors nirmatrelvir plus ritonavir.|Post-hoc analysis of gastrointestinal symptoms data||2.47|0.79|0.25
72565828|NCT02709486|144662707|SUPERIORITY||Least Square Mean Difference|-6.75|STANDARD_ERROR_OF_MEAN|3.79||0.0774|TWO_SIDED|95.0|-14.26|0.76|||ANCOVA|||Week 8: Percent Overall Work Impairment: WPAI parameters were analyzed using ANCOVA model which included covariates of the corresponding baseline score, baseline diary average pain, index joint, highest Kellgren-Lawrence grade (2, 3 or 4), and treatment, with study site as a random effect.||0.76|-14.26|0.0774
72398097|NCT00268996|144302080|SUPERIORITY_OR_OTHER||Adjusted Treatment Difference|-0.584||||0.854|TWO_SIDED|95.0|-6.819|5.65|||ANCOVA|Data analyzed using ANCOVA, with ACS status, pooled country, baseline value, matched segment length and treatment included as covariates.|Difference in adjusted means are shown (Darapladib 160 mg EC tablet one daily - Placebo).|Placebo vs Darapladib 160 mg EC tablet: Fibrous tissue volume||5.650|-6.819|0.854
72398098|NCT00268996|144302080|SUPERIORITY_OR_OTHER||Adjusted Treatment Difference|1.926||||0.418|TWO_SIDED|95.0|-2.748|6.6||Data analyzed using ANCOVA, with ACS status, pooled country, baseline value, matched segment length and treatment included as covariates.|ANCOVA||Difference in adjusted means are shown (Darapladib 160 mg EC tablet one daily - Placebo).|Placebo vs Darapladib 160 mg EC tablet: Fibro-fatty volume||6.600|-2.748|0.418
72398099|NCT00268996|144302081|SUPERIORITY_OR_OTHER||Adjusted Treatment Difference|2.0||||0.021|TWO_SIDED|95.0|0.299|3.701|||ANOVA|Data analyzed using ANCOVA, with ACS status, pooled country, baseline value, matched segment length and treatment included as covariates.|Difference in adjusted means are shown (Darapladib 160 mg EC tablet one daily - Placebo).|Placebo vs Darapladib 160 mg EC tablet: Fibrous tissue as % of VH plaque||3.701|0.299|0.021
72398100|NCT00268996|144302081|SUPERIORITY_OR_OTHER||Adjusted Treatment Difference|0.739||||0.54|TWO_SIDED|95.0|-1.635|3.114|||ANCOVA|Data analyzed using ANCOVA, with ACS status, pooled country, baseline value, matched segment length and treatment included as covariates.|Difference in adjusted means are shown (Darapladib 160 mg EC tablet one daily - Placebo).|Placebo vs Darapladib 160 mg EC tablet: Fibro-fatty as percentage of VH plaque||3.114|-1.635|0.540
72398101|NCT01528254|144302122|SUPERIORITY||Hazard Ratio (HR)|0.51|||<|0.001|TWO_SIDED|95.0|0.45|0.58|||Regression, Cox|||||0.58|0.45|<0.001
72398102|NCT01528254|144302123|OTHER||Slope|-0.02|STANDARD_ERROR_OF_MEAN|0.01||0.042|TWO_SIDED|95.0|-0.05|0.0|||Mixed Models Analysis|||||0.00|-0.05|0.042
72398103|NCT01528254|144302124|OTHER||Slope|0.09|STANDARD_ERROR_OF_MEAN|0.19||0.635|TWO_SIDED|95.0|-0.29|0.47|||Mixed Models Analysis|||||0.47|-0.29|0.635
72398104|NCT01528254|144302125|OTHER||Slope|-0.01|STANDARD_ERROR_OF_MEAN|0.02||0.53|TWO_SIDED|95.0|-0.05|0.02|||Mixed Models Analysis|||||0.02|-0.05|0.530
72398105|NCT01528254|144302126|OTHER||Slope|0.28|STANDARD_ERROR_OF_MEAN|0.32||0.381|TWO_SIDED|95.0|-0.35|0.9|||Mixed Models Analysis|||||0.90|-0.35|0.381
72398106|NCT01528254|144302127|OTHER||Slope|-0.08|STANDARD_ERROR_OF_MEAN|0.23||0.744|TWO_SIDED|95.0|-0.53|0.38|||Mixed Models Analysis|||From Week 13 to end of Period 1||0.38|-0.53|0.744
72398107|NCT01528254|144302127|OTHER||Slope|-0.5|STANDARD_ERROR_OF_MEAN|0.21||0.017|TWO_SIDED|95.0|-0.91|-0.09|||Mixed Models Analysis|||From Week 13 to end of Period 2||-0.09|-0.91|0.017
72398108|NCT01528254|144302127|OTHER||Slope|-0.58|STANDARD_ERROR_OF_MEAN|0.21||0.006|TWO_SIDED|95.0|-0.99|-0.17|||Mixed Models Analysis|||From Week 13 to end of study||-0.17|-0.99|0.006
72398109|NCT01528254|144302128|OTHER||Slope|-5.03|STANDARD_ERROR_OF_MEAN|2.16||0.02|TWO_SIDED|95.0|-9.26|-0.79|||Mixed Models Analysis|||From Week 13 to end of Period 1||-0.79|-9.26|0.020
72398110|NCT01528254|144302128|OTHER||Slope|-5.08|STANDARD_ERROR_OF_MEAN|1.73||0.003|TWO_SIDED|95.0|-8.46|-1.69|||Mixed Models Analysis|||From Week 13 to end of Period 2||-1.69|-8.46|0.003
72473207|NCT03008005|144470142|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||< 0.05
72473208|NCT03008005|144470143|SUPERIORITY||||||<|0.05|||||||Chi-squared|||||||< 0.05
72473209|NCT01040169|144470171|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
72473210|NCT01040169|144470172|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
72473211|NCT00558792|144470213|SUPERIORITY_OR_OTHER|||||||0.0099||95.0|||||Chi-squared|||||||0.0099
72398111|NCT01528254|144302128|OTHER||Slope|-5.38|STANDARD_ERROR_OF_MEAN|1.64||0.001|TWO_SIDED|95.0|-8.61|-2.16|||Mixed Models Analysis|||From Week 13 to end of study||-2.16|-8.61|0.001
72473212|NCT00558792|144470214|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Chi-squared|||||||<0.0001
72473213|NCT00558792|144470215|SUPERIORITY_OR_OTHER|||||||0.1212||95.0|||||Chi-squared|||||||0.1212
72473214|NCT00558792|144470217|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||ANOVA|||||||0.0200
72473215|NCT00558792|144470218|SUPERIORITY_OR_OTHER|||||||0.0044||95.0|||||ANOVA|||||||0.0044
72473216|NCT00558792|144470219|SUPERIORITY_OR_OTHER|||||||0.0371||95.0|||||ANOVA|||||||0.0371
72473217|NCT00558792|144470220|SUPERIORITY_OR_OTHER||Difference in Sensitivity between Doses|14.1||||0.2758|TWO_SIDED|95.0|-11.4|39.6||Study was not powered for diagnostic performance analyses. Sample size was based on quality of visualization of coronary artery segments.|Chi-squared|||||39.6|-11.4|0.2758
72473218|NCT00558792|144470220|SUPERIORITY_OR_OTHER||Difference in Sensitivity between Doses|12.3||||0.3102|TWO_SIDED|95.0|-11.1|35.6||Study was not powered for diagnostic performance analyses. Sample size was based on quality of visualization of coronary artery segments.|Chi-squared|||||35.6|-11.1|0.3102
72473219|NCT00558792|144470220|SUPERIORITY_OR_OTHER||Difference in Sensitivity between Doses|1.9||||0.8893|TWO_SIDED|95.0|-24.6|28.4||Study was not powered for diagnostic performance analyses. Sample size was based on quality of visualization of coronary artery segments.|Chi-squared|||||28.4|-24.6|0.8893
72473220|NCT00558792|144470221|SUPERIORITY_OR_OTHER||Difference in Specificity between Doses|-1.7||||0.2511|TWO_SIDED|95.0|-4.7|1.3||Study was not powered for diagnostic performance analyses. Sample size was based on quality of visualization of coronary artery segments.|Chi-squared|||||1.3|-4.7|0.2511
72506929|NCT02345161|144546046|SUPERIORITY_OR_OTHER||LS Mean difference|-0.77|STANDARD_ERROR_OF_MEAN|0.122|<|0.001|TWO_SIDED|95.0|-1.01|-0.54|||Mixed Model Repeated Measures||Breathlessness EXACT-RS Score, Week 21-24|||-0.54|-1.01|<0.001
72506930|NCT02345161|144546046|SUPERIORITY_OR_OTHER||LS Mean difference|-0.17|STANDARD_ERROR_OF_MEAN|0.044|<|0.001|TWO_SIDED|95.0|-0.26|-0.09|||Mixed Model Repeated Measures||Cough and sputum EXACT-RS Score, Week 1-4|||-0.09|-0.26|<0.001
72506931|NCT02345161|144546046|SUPERIORITY_OR_OTHER||LS Mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.053|<|0.001|TWO_SIDED|95.0|-0.31|-0.1|||Mixed Model Repeated Measures||Cough and sputum EXACT-RS Score, Week 5-8|||-0.10|-0.31|<0.001
72506932|NCT02345161|144546046|SUPERIORITY_OR_OTHER||LS Mean difference|-0.17|STANDARD_ERROR_OF_MEAN|0.058||0.004|TWO_SIDED|95.0|-0.28|-0.05|||Mixed Model Repeated Measures||Cough and sputum EXACT-RS Score, Week 9-12|||-0.05|-0.28|0.004
72473221|NCT00558792|144470221|SUPERIORITY_OR_OTHER||Difference in Specificity between Doses|1.3||||0.4985|TWO_SIDED|95.0|-2.6|5.3||Study was not powered for diagnostic performance analyses. Sample size was based on quality of visualization of coronary artery segments.|Chi-squared|||||5.3|-2.6|0.4985
72473222|NCT00558792|144470221|SUPERIORITY_OR_OTHER||Difference in Specificity between Doses|-3.1||||0.0693|TWO_SIDED|95.0|-6.5|0.4||Study was not powered for diagnostic performance analyses. Sample size was based on quality of visualization of coronary artery segments.|Chi-squared|||||0.4|-6.5|0.0693
72473223|NCT00558792|144470222|SUPERIORITY_OR_OTHER||Difference in Sensitivity between Doses|-1.5||||0.9104|TWO_SIDED|95.0|-27.9|24.8||Study was not powered for diagnostic performance analyses. Sample size was based on quality of visualization of coronary artery segments.|Chi-squared|||||24.8|-27.9|0.9104
72473224|NCT00558792|144470222|SUPERIORITY_OR_OTHER||Difference in Sensitivity between Doses|-12.6||||0.2857|TWO_SIDED|95.0|-35.7|10.5||Study was not powered for diagnostic performance analyses. Sample size was based on quality of visualization of coronary artery segments.|Chi-squared|||||10.5|-35.7|0.2857
72473225|NCT00558792|144470222|SUPERIORITY_OR_OTHER||Difference in Sensitivity between Doses|11.1||||0.3664|TWO_SIDED|95.0|-13.3|35.5||Study was not powered for diagnostic performance analyses. Sample size was based on quality of visualization of coronary artery segments.|Chi-squared|||||35.5|-13.3|0.3664
72473226|NCT00558792|144470223|SUPERIORITY_OR_OTHER||Difference in Specifcity between Doses|-3.7||||0.1322|TWO_SIDED|95.0|-8.7|1.2||Study was not powered for diagnostic performance analyses. Sample size was based on quality of visualization of coronary artery segments.|Chi-squared|||||1.2|-8.7|0.1322
72473227|NCT00558792|144470223|SUPERIORITY_OR_OTHER||Difference in Specificity between Doses|-1.3||||0.6381|TWO_SIDED|95.0|-6.9|4.2||Study was not powered for diagnostic performance analyses. Sample size was based on quality of visualization of coronary artery segments.|Chi-squared|||||4.2|-6.9|0.6381
72473228|NCT00558792|144470223|SUPERIORITY_OR_OTHER||Difference in Specificity between Doses|-2.4||||0.3217|TWO_SIDED|95.0|-7.2|2.4||Study was not powered for diagnostic performance analyses. Sample size was based on quality of visualization of coronary artery segments.|Chi-squared|||||2.4|-7.2|0.3217
72473229|NCT00558792|144470224|SUPERIORITY_OR_OTHER||Difference in Sensitivity between Doses|7.6||||0.5843|TWO_SIDED|95.0|-19.6|34.7||Study was not powered for diagnostic performance analyses. Sample size was based on quality of visualization of coronary artery segments.|Chi-squared|||||34.7|-19.6|0.5843
72473230|NCT00558792|144470224|SUPERIORITY_OR_OTHER||Difference in Sensitivity between Doses|4.6||||0.7197|TWO_SIDED|95.0|-20.5|29.7||Study was not powered for diagnostic performance analyses. Sample size was based on quality of visualization of coronary artery segments.|Chi-squared|||||29.7|-20.5|0.7197
72473231|NCT00558792|144470224|SUPERIORITY_OR_OTHER||Difference in Sensitivity between Doses|3.0||||0.8292|TWO_SIDED|95.0|-24.1|30.1||Study was not powered for diagnostic performance analyses. Sample size was based on quality of visualization of coronary artery segments.|Chi-squared|||||30.1|-24.1|0.8292
72473232|NCT00558792|144470225|SUPERIORITY_OR_OTHER||Difference in Specificity between Doses|-4.2||||0.0888|TWO_SIDED|95.0|-9.0|0.7||Study was not powered for diagnostic performance analyses. Sample size was based on quality of visualization of coronary artery segments.|Chi-squared|||||0.7|-9.0|0.0888
72506933|NCT02345161|144546046|SUPERIORITY_OR_OTHER||LS Mean difference|-0.22|STANDARD_ERROR_OF_MEAN|0.061|<|0.001|TWO_SIDED|95.0|-0.34|-0.1|||Mixed Model Repeated Measures||Cough and sputum EXACT-RS Score, Week 13-16|||-0.10|-0.34|<0.001
72506934|NCT02345161|144546046|SUPERIORITY_OR_OTHER||LS Mean difference|-0.24|STANDARD_ERROR_OF_MEAN|0.064|<|0.001|TWO_SIDED|95.0|-0.36|-0.11|||Mixed Model Repeated Measures||Cough and sputum EXACT-RS Score, Week 17-20|||-0.11|-0.36|<0.001
72506935|NCT02345161|144546046|SUPERIORITY_OR_OTHER||LS Mean difference|-0.23|STANDARD_ERROR_OF_MEAN|0.065|<|0.001|TWO_SIDED|95.0|-0.35|-0.1|||Mixed Model Repeated Measures||Cough and sputum EXACT-RS Score, Week 21-24|||-0.10|-0.35|<0.001
72506936|NCT02345161|144546046|SUPERIORITY_OR_OTHER||LS Mean difference|-0.27|STANDARD_ERROR_OF_MEAN|0.049|<|0.001|TWO_SIDED|95.0|-0.37|-0.18|||Mixed Model Repeated Measures||Chest EXACT-RS Scores, Week 1-4|||-0.18|-0.37|<0.001
72506937|NCT02345161|144546046|SUPERIORITY_OR_OTHER||LS Mean difference|-0.34|STANDARD_ERROR_OF_MEAN|0.06|<|0.001|TWO_SIDED|95.0|-0.46|-0.23|||Mixed Model Repeated Measures||Chest EXACT-RS Scores, Week 5-8|||-0.23|-0.46|<0.001
72398112|NCT04339296|144302133|EQUIVALENCE|An independent sample t-test was performed between intervention and control group to determine if the difference of the mean medication adherence is equal to zero (null hypothesis).|Mean Difference (Net)|7.18|||<|0.01|TWO_SIDED|||||Statistical test was set at 95% confidence level.|t-test, 2 sided||Medication Adherence Difference = Intervention Adherence - Control Adherence|||||<0.01
72398113|NCT04339296|144302134|EQUIVALENCE|The null hypothesis assumes that the true mean difference for intervention participants self-reported medication adherence scores (from baseline to 6-month) is equal to zero.|Mean Difference (Net)|-1.5|||<|0.01|TWO_SIDED|||||Statistical test was set at 95% confidence level.|t-test, 2 sided||Mean difference (intervention participants self-reported score) = baseline minus 6-month.|||||<0.01
72473233|NCT00558792|144470225|SUPERIORITY_OR_OTHER||Difference in Specificity between Doses|-0.8||||0.7796|TWO_SIDED|95.0|-6.4|4.8||Study was not powered for diagnostic performance analyses. Sample size was based on quality of visualization of coronary artery segments.|Chi-squared|||||4.8|-6.4|0.7796
72473234|NCT00558792|144470225|SUPERIORITY_OR_OTHER||Difference in Specificity between Doses|-3.4||||0.1662|TWO_SIDED|95.0|-8.2|1.5||Study was not powered for diagnostic performance analyses. Sample size was based on quality of visualization of coronary artery segments.|Chi-squared|||||1.5|-8.2|0.1662
72473235|NCT02284009|144470271|SUPERIORITY||Mean Difference (Final Values)|0.12|||||TWO_SIDED|95.0|0.0|0.24|||||Analysis was performed using a Bayesian model incorporating historical placebo data using a robust mixture prior. Values above are 95% credible intervals. Probability of treatment difference (Albiglutide - Placebo) \>= 0.2 nmol/L = 0.097.|||0.24|0.00|
72473236|NCT04092530|144470349|OTHER||Risk Ratio (RR)|0.82||||0.12|TWO_SIDED|95.0|0.64|1.05|||Mixed Models Analysis|Adjusted for time; clustering by clinical site accounted for with random intercept||Please note that there were only 7 units (community health clinics) analyzed at Level 2 of this multilevel study, but due to the crossover design of the study, they were each observed under both the Control and Intervention conditions. Therefore, the Units Analyzed entered above reflect the 7 clinics under both conditions and should not be summed to 14.||1.05|0.64|0.12
72473237|NCT04092530|144470350|OTHER||Risk Ratio (RR)|0.89||||0.33|TWO_SIDED|95.0|0.7|1.13|||Mixed Models Analysis|Adjusted for time; random intercept for clinical site||||1.13|0.70|0.33
72473238|NCT04092530|144470351|OTHER||Risk Ratio (RR)|1.1||||0.88|TWO_SIDED|95.0|0.33|3.73|||Mixed Models Analysis|Adjusted for time; random intercept for clinical site||||3.73|0.33|0.88
72506938|NCT02345161|144546046|SUPERIORITY_OR_OTHER||LS Mean difference|-0.34|STANDARD_ERROR_OF_MEAN|0.066|<|0.001|TWO_SIDED|95.0|-0.47|-0.21|||Mixed Model Repeated Measures||Chest EXACT-RS Scores, Week 9-12|||-0.21|-0.47|<0.001
72398114|NCT04339296|144302134|EQUIVALENCE|The null hypothesis assumes that the true mean difference for control participants self-reported medication adherence scores (from baseline to 6-month) is equal to zero.|Mean Difference (Net)|-1.07||||0.07|TWO_SIDED|||||Statistical tests was set at 95% confidence level.|t-test, 2 sided||Mean difference (control participants self-reported score) = baseline minus 6-month.|||||0.07
72473239|NCT03317990|144470400|SUPERIORITY||Mean Difference (Final Values)|3.18|||<|0.0001|TWO_SIDED|95.0|1.62|4.75|||Regression, Linear|||Normal linear regression model adjusted for recruitment site, participant's age, and IIEF-5 at baseline, in participants with available data||4.75|1.62|<0.0001
72473240|NCT03317990|144470401|SUPERIORITY||Mean Difference (Final Values)|-1.41||||0.006|TWO_SIDED|95.0|-2.42|-0.41|||Regression, Linear|||||-0.41|-2.42|0.006
72506939|NCT02345161|144546046|SUPERIORITY_OR_OTHER||LS Mean difference|-0.38|STANDARD_ERROR_OF_MEAN|0.068|<|0.001|TWO_SIDED|95.0|-0.51|-0.25|||Mixed Model Repeated Measures||Chest EXACT-RS Scores, Week 13-16|||-0.25|-0.51|<0.001
72506940|NCT02345161|144546046|SUPERIORITY_OR_OTHER||LS Mean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.071|<|0.001|TWO_SIDED|95.0|-0.53|-0.26|||Mixed Model Repeated Measures||Chest EXACT-RS Scores, Week 17-20|||-0.26|-0.53|<0.001
72398115|NCT04446377|144302142|SUPERIORITY|The alternative hypothesis for the statistical testing was that LAM-002A would induce greater changes in viral load from Day 1 to Day 4 than would Placebo.|Mean Difference (Final Values)|-0.47|STANDARD_ERROR_OF_MEAN|0.51||0.35|TWO_SIDED|95.0|-1.47|0.53||Pre-specified 2-sided significance level of 0.20|Mixed Models Analysis|ANCOVA linear mixed model to evaluate the relative differences between the LAM-002A and Placebo groups in the log10 viral load from Day 1 to Day 4.|The difference between the groups (LAM-002A vs Placebo).|The analysis tested whether the viral load in nasopharyngeal samples was lower at Day 4 in those receiving LAM-002A compared to Placebo.||0.53|-1.47|0.35
72506941|NCT02345161|144546046|SUPERIORITY_OR_OTHER||LS Mean difference|-0.36|STANDARD_ERROR_OF_MEAN|0.072|<|0.001|TWO_SIDED|95.0|-0.5|-0.22|||Mixed Model Repeated Measures||Chest EXACT-RS Scores, Week 21-24|||-0.22|-0.50|<0.001
72473241|NCT03301155|144470431|SUPERIORITY|||||||0.001|||||||Regression, Logistic|Comparison performed on the regression parameters scale. Estimates for mean time obtained under assumption of exponentially distributed time-to-event.||||||0.001
72473242|NCT03301155|144470431|SUPERIORITY|superiority margin for hazard ratio was prespecified as 0.846. Lower hazard is better thus the upper confidence limit of HR expected to be lesser than margin|Hazard Ratio (HR)|0.645||||0.0218|TWO_SIDED|95.0|0.496|0.839|||Regression, Cox||Lower HR is better|||0.839|0.496|0.0218
72473243|NCT03301155|144470432|SUPERIORITY|||||||0.0003||||||Adjusted with Holm method for multiple comparrisons|Fisher Exact|||Comparison between groups on week 4||||0.0003
72473244|NCT03301155|144470432|SUPERIORITY|Adjusted with Holm method for multiple comparrisons||||||0.0003|||||||Fisher Exact|||Comparison between groups on week 8||||0.0003
72473245|NCT03301155|144470432|SUPERIORITY|||||||0.0021|||||||Fisher Exact|||Comparison between groups on week 12||||0.0021
72473246|NCT03301155|144470433|SUPERIORITY|||||||0.1372|||||||Fisher Exact|||||||0.1372
72473247|NCT03301155|144470434|SUPERIORITY||||||>|0.999|||||||Fisher Exact|||||||>0.999
72473248|NCT03301155|144470435|SUPERIORITY||||||>|0.999|||||||Fisher Exact|||||||>0.999
72473249|NCT00384189|144470436|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|9.8|STANDARD_ERROR_OF_MEAN|4.3||0.0116|TWO_SIDED|95.0|1.4|18.3|||ANCOVA|Baseline value and age as covariates. One-sided p-value, significance level 2.5%.||||18.3|1.4|0.0116
72473250|NCT00384189|144470436|SUPERIORITY_OR_OTHER||Least Square Means Difference|9.4|STANDARD_ERROR_OF_MEAN|4.3||0.0148|TWO_SIDED|95.0|0.9|17.8|||ANCOVA|Baseline value and age as covariates. One-sided p-value, significance level 2.5%.||||17.8|0.9|0.0148
72506942|NCT02345161|144546047|SUPERIORITY_OR_OTHER||LS Mean difference|-0.52|STANDARD_ERROR_OF_MEAN|0.311||0.094|TWO_SIDED|95.0|-1.13|0.09|||Mixed Model Repeated Measures||EXACT-RS Scores, Week 1-4|||0.09|-1.13|0.094
72565829|NCT02709486|144662707|SUPERIORITY||Least Square Mean Difference|-12.48|STANDARD_ERROR_OF_MEAN|3.87||0.0017|TWO_SIDED|95.0|-20.15|-4.81|||ANCOVA|||Week 8: Percent Overall Work Impairment: WPAI parameters were analyzed using ANCOVA model which included covariates of the corresponding baseline score, baseline diary average pain, index joint, highest Kellgren-Lawrence grade (2, 3 or 4), and treatment, with study site as a random effect.||-4.81|-20.15|0.0017
72565830|NCT02709486|144662707|SUPERIORITY||Least Square Mean Difference|-9.41|STANDARD_ERROR_OF_MEAN|3.74||0.0135|TWO_SIDED|95.0|-16.83|-1.99|||ANCOVA|||Week 16: Percent Overall Work Impairment: WPAI parameters were analyzed using ANCOVA model which included covariates of the corresponding baseline score, baseline diary average pain, index joint, highest Kellgren-Lawrence grade (2, 3 or 4), and treatment, with study site as a random effect.||-1.99|-16.83|0.0135
72565831|NCT02709486|144662707|SUPERIORITY||Least Square Mean Difference|-10.04|STANDARD_ERROR_OF_MEAN|3.97||0.0129|TWO_SIDED|95.0|-17.91|-2.17|||ANCOVA|||Week 16: Percent Overall Work Impairment: WPAI parameters were analyzed using ANCOVA model which included covariates of the corresponding baseline score, baseline diary average pain, index joint, highest Kellgren-Lawrence grade (2, 3 or 4), and treatment, with study site as a random effect.||-2.17|-17.91|0.0129
72623061|NCT02904096|144776394|OTHER|||||||0.177|||||||t-test, 1 sided|||Comparison between Group B: Hand palmar pinch strength (Right Hand)-baseline and Group B: Hand palmar pinch strength (Right Hand)-change from baseline at Month 24.||||.177
72473251|NCT00384189|144470436|SUPERIORITY_OR_OTHER||Least Squares Means Difference|12.0|STANDARD_ERROR_OF_MEAN|4.3||0.0028|TWO_SIDED|95.0|3.5|20.4|||ANCOVA|Baseline value and age as covariates. One-sided p-value, significance level 2.5%.||||20.4|3.5|0.0028
72473252|NCT00384189|144470437|SUPERIORITY_OR_OTHER|||||||0.1362||||||Two-sided p-value, significance level 5%.|Log Rank|||||||0.1362
72473253|NCT00384189|144470437|SUPERIORITY_OR_OTHER|||||||0.0891||||||Two-sided p-value, significance level 5%.|Log Rank|||||||0.0891
72506943|NCT02345161|144546047|SUPERIORITY_OR_OTHER||LS Mean difference|-1.07|STANDARD_ERROR_OF_MEAN|0.371||0.004|TWO_SIDED|95.0|-1.8|-0.34|||Mixed Model Repeated Measures||EXACT-RS Scores, Week 5-8|||-0.34|-1.80|0.004
72506944|NCT02345161|144546047|SUPERIORITY_OR_OTHER||LS Mean difference|-0.97|STANDARD_ERROR_OF_MEAN|0.419||0.022|TWO_SIDED|95.0|-1.79|-0.14|||Mixed Model Repeated Measures||EXACT-RS Scores, Week 9-12|||-0.14|-1.79|0.022
72506945|NCT02345161|144546047|SUPERIORITY_OR_OTHER||LS Mean difference|-1.01|STANDARD_ERROR_OF_MEAN|0.445||0.024|TWO_SIDED|95.0|-1.88|-0.13|||Mixed Model Repeated Measures||EXACT-RS Scores, Week 13-16|||-0.13|-1.88|0.024
72506946|NCT02345161|144546047|SUPERIORITY_OR_OTHER||LS Mean difference|-1.11|STANDARD_ERROR_OF_MEAN|0.481||0.021|TWO_SIDED|95.0|-2.06|-0.17|||Mixed Model Repeated Measures||EXACT-RS Scores, Week 17-20|||-0.17|-2.06|0.021
72506947|NCT02345161|144546047|SUPERIORITY_OR_OTHER||LS Mean difference|-1.11|STANDARD_ERROR_OF_MEAN|0.481||0.022|TWO_SIDED|95.0|-2.05|-0.16|||Mixed Model Repeated Measures||EXACT-RS Score, Week 21-24|||-0.16|-2.05|0.022
72506948|NCT02345161|144546047|SUPERIORITY_OR_OTHER||LS Mean difference|-1.32|STANDARD_ERROR_OF_MEAN|0.492||0.008|TWO_SIDED|95.0|-2.29|-0.35|||Mixed Model Repeated Measures||EXACT-RS Scores, Week 25-28|||-0.35|-2.29|0.008
72506949|NCT02345161|144546047|SUPERIORITY_OR_OTHER||LS Mean difference|-1.43|STANDARD_ERROR_OF_MEAN|0.494||0.004|TWO_SIDED|95.0|-2.4|-0.46|||Mixed Model Repeated Measures||EXACT-RS Scores, Week 29-32|||-0.46|-2.40|0.004
72565832|NCT02709486|144662707|SUPERIORITY||Least Square Mean Difference|-3.85|STANDARD_ERROR_OF_MEAN|4.43||0.3869|TWO_SIDED|95.0|-12.66|4.96|||ANCOVA|||Week 24: Percent Overall Work Impairment: WPAI parameters were analyzed using ANCOVA model which included covariates of the corresponding baseline score, baseline diary average pain, index joint, highest Kellgren-Lawrence grade (2, 3 or 4), and treatment, with study site as a random effect.||4.96|-12.66|0.3869
72565833|NCT02709486|144662707|SUPERIORITY||Least Square Mean Difference|-2.11|STANDARD_ERROR_OF_MEAN|4.62||0.6485|TWO_SIDED|95.0|-11.31|7.08|||ANCOVA|||Week 24: Percent Overall Work Impairment: WPAI parameters were analyzed using ANCOVA model which included covariates of the corresponding baseline score, baseline diary average pain, index joint, highest Kellgren-Lawrence grade (2, 3 or 4), and treatment, with study site as a random effect.||7.08|-11.31|0.6485
72623062|NCT04003389|144776425|SUPERIORITY||LSMean difference|-0.08|STANDARD_ERROR_OF_MEAN|0.14||0.0604|TWO_SIDED|95.0|-0.36|0.21||LSM, SE, CI, \& p-values come from an analysis of covariance (ANCOVA) model with change from baseline at Week 52 timepoint as response, treatment \& smoking status (current vs former/never) as fixed effects with baseline weight \& baseline as covariate.|ANCOVA|||LSMeans (LSM), standard errors (SE), confidence intervals (CI)||0.21|-0.36|0.0604
72623063|NCT04003389|144776425|SUPERIORITY||LSMean difference|-0.17|STANDARD_ERROR_OF_MEAN|0.14||0.239|TWO_SIDED|95.0|-0.45|0.11||The LSM, SE, CI, and p-values come from an ANCOVA model with change from baseline at the Week 52 timepoint as response, treatment and smoking status (current vs former/never) as fixed effects with baseline weight and baseline as covariates.|ANCOVA|||||0.11|-0.45|0.239
72473254|NCT00384189|144470437|SUPERIORITY_OR_OTHER|||||||0.1574||||||Two-sided p-value, significance level 5%.|Log Rank|||||||0.1574
72473255|NCT00384189|144470438|SUPERIORITY_OR_OTHER|||||||0.001||||||One-sided p-value for superiority, significance level 2.5%.|Wilcoxon (Mann-Whitney)|||||||0.0010
72473256|NCT00384189|144470438|SUPERIORITY_OR_OTHER|||||||0.0006||||||One-sided p-value for superiority, significance level 2.5%.|Wilcoxon (Mann-Whitney)|||||||0.0006
72473257|NCT00384189|144470438|SUPERIORITY_OR_OTHER|||||||0.0002||||||One-sided p-value for superiority, significance level 2.5%.|Wilcoxon (Mann-Whitney)|||||||0.0002
72506950|NCT02345161|144546047|SUPERIORITY_OR_OTHER||LS Mean difference|-1.5|STANDARD_ERROR_OF_MEAN|0.519||0.004|TWO_SIDED|95.0|-2.52|-0.48|||Mixed Model Repeated Measures||EXACT-RS Scores, Week 33-36|||-0.48|-2.52|0.004
72506951|NCT02345161|144546047|SUPERIORITY_OR_OTHER||LS Mean difference|-1.23|STANDARD_ERROR_OF_MEAN|0.507||0.016|TWO_SIDED|95.0|-2.22|-0.23|||Mixed Model Repeated Measures||EXACT-RS Scores, Week 37-40|||-0.23|-2.22|0.016
72506952|NCT02345161|144546047|SUPERIORITY_OR_OTHER||LS Mean difference|-1.49|STANDARD_ERROR_OF_MEAN|0.513||0.04|TWO_SIDED|95.0|-2.5|-0.48|||Mixed Model Repeated Measures||EXACT-RS Scores, Week 41-44|||-0.48|-2.50|0.04
72506953|NCT02345161|144546047|SUPERIORITY_OR_OTHER||LS Mean difference|-1.53|STANDARD_ERROR_OF_MEAN|0.525||0.007|TWO_SIDED|95.0|-2.56|-0.5|||Mixed Model Repeated Measures||EXACT-RS Scores, Week 45-49|||-0.50|-2.56|0.007
72506954|NCT02345161|144546047|SUPERIORITY_OR_OTHER||LS Mean difference|-1.42|STANDARD_ERROR_OF_MEAN|0.524||0.007|TWO_SIDED|95.0|-2.45|-0.39|||Mixed Model Repeated Measures||EXACT-RS Scores, Week 49-52|||-0.39|-2.45|0.007
72398116|NCT04446377|144302144|SUPERIORITY|The alternative hypothesis for the statistical testing was that LAM-002A would reduce the cumulative rate of hospitalization or death during the 28-day period comprising 10 days of study drug administration and a further 18 days of observation.|Odds Ratio (OR)|2.03||||0.55|TWO_SIDED|95.0|0.18|22.89|||Log Rank|||||22.89|0.18|0.55
72398117|NCT04446377|144302146|SUPERIORITY|The alternative hypothesis for the statistical testing was that a higher proportion of participants would have ≥95% oxygen saturation during LAM-002A administration than during Placebo administration as assessed across Days 1, 4, and 11 of the study drug course.|Risk Difference (RD)|-1.4|||||TWO_SIDED|||||||||Risk Difference from generalized estimating equations (GEE) logistic regression at Baseline||||
72398118|NCT04446377|144302146|SUPERIORITY|The alternative hypothesis for the statistical testing was that a higher proportion of participants would have ≥95% oxygen saturation during LAM-002A administration than during Placebo administration as assessed across Days 1, 4, and 11 of the study drug course.|Risk Difference (RD)|-1.0|||||TWO_SIDED|||||||||Risk Difference from GEE Logistic Regression at Day 1||||
72398119|NCT04446377|144302146|SUPERIORITY|The alternative hypothesis for the statistical testing was that a higher proportion of participants would have ≥95% oxygen saturation during LAM-002A administration than during Placebo administration as assessed across Days 1, 4, and 11 of the study drug course.|Risk Difference (RD)|-8.8|||||TWO_SIDED|||||||||Risk Difference from GEE logistic regression at Day 4||||
72398120|NCT04446377|144302146|SUPERIORITY|The alternative hypothesis for the statistical testing was that a higher proportion of participants would have ≥95% oxygen saturation during LAM-002A administration than during Placebo administration as assessed across Days 1, 4, and 11 of the study drug course.|Risk Difference (RD)|-3.7|||||TWO_SIDED|||||||||Risk Difference from GEE logistic regression at Day 11||||
72473258|NCT04546425|144470468|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC-13vPnC) was greater than -10%.|Percent Difference :|-13.5|||||TWO_SIDED|95.0|-18.3|-8.7|||||2-Sided 95% CIs were calculated using the Miettinen and Nurminen method for the difference in proportions, expressed as a percentage.|Serotype 1||-8.7|-18.3|
72398121|NCT04446377|144302147|SUPERIORITY|The alternative hypothesis for the statistical testing was that, relative to Placebo, LAM-002A would result in a greater proportion of participants with a SARS-CoV-2 viral load \<LLOQ on Day 4.|Relative Risk|2.51||||0.2|TWO_SIDED|95.0|0.74|8.48||Prespecified significance level of 0.20.|Fisher Exact|||||8.48|0.74|0.20
72398122|NCT03557151|144302154|SUPERIORITY||Slope|-0.04|STANDARD_ERROR_OF_MEAN|0.33||0.895|TWO_SIDED|95.0|-0.68|0.6|||Mixed Models Analysis|||Transdisciplinary Care is being compared to Usual Care using the Time 2 HbA1c (as baseline) and Time 5 HbA1c (as the outcome) controlling for race/ethnicity, gender, and age of the patient. The interaction of condition and time is used to evaluate the treatment effect. Missing data were not imputed.||0.60|-0.68|0.895
72398123|NCT03557151|144302155|SUPERIORITY||Slope|2.29|STANDARD_ERROR_OF_MEAN|2.34||0.33|TWO_SIDED|95.0|-2.29|6.88|||Mixed Models Analysis|||TC is being compared to UC using baseline and 12 month data, controlling for patient age, sex, and race/ethnicity. The interaction between condition and time is used to examine the treatment effect. Missing data were not imputed.||6.88|-2.29|.33
72398124|NCT03557151|144302156|SUPERIORITY||Slope|4.1|STANDARD_ERROR_OF_MEAN|2.25||0.07|TWO_SIDED|95.0|-0.32|8.53|||Mixed Models Analysis|||TC is being compared to UC using baseline and 12 month data and controlling for patient age, sex, and race/ethnicity. The interaction between condition and time is used to evaluate the treatment effect. Missing data are not imputed.||8.53|-.32|.07
72398125|NCT03557151|144302157|SUPERIORITY||Slope|-2.38|STANDARD_ERROR_OF_MEAN|3.77||0.527|TWO_SIDED|95.0|-9.77|5.0|||Mixed Models Analysis|||This analysis included baseline and 12-month data. The interaction of condition (TC or UC) and time was used to examine the treatment effect. Child sex, age, and race/ethnicity were covariates. Missing data were not imputed.||5.0|-9.77|.527
72398126|NCT03557151|144302158|SUPERIORITY||Slope|-3.3|STANDARD_ERROR_OF_MEAN|2.89||0.253|TWO_SIDED|95.0|-8.94|2.35|||Mixed Models Analysis|||This analysis uses baseline and 12 month data. The interaction of condition and time is used to evaluate the treatment effect. Child sex, age, and race/ethnicity were used as covariates. Missing data were not imputed.||2.35|-8.94|.253
72398127|NCT03557151|144302159|SUPERIORITY||Slope|9.69|STANDARD_ERROR_OF_MEAN|3.77||0.01|TWO_SIDED|95.0|2.31|17.08|||Mixed Models Analysis|||This analysis included baseline and 12 month data. The condition by time interaction was used to evaluate the treatment effect. Child age, sex, and race/ethnicity were included as covariates. Missing data were not imputed.||17.08|2.31|0.01
72398128|NCT03557151|144302160|SUPERIORITY||Slope|0.45|STANDARD_ERROR_OF_MEAN|2.07||0.83|TWO_SIDED|95.0|-3.62|4.35|||Mixed Models Analysis|||This analysis uses baseline and 12-month data. The interaction between condition and time is used to evaluate the treatment effect. Child age, sex, and race/ethnicity were covariates. Missing data were not imputed.||4.35|-3.62|.83
72398129|NCT01414075|144302161|OTHER|||||||0.0757||||||Threshold for significance at 0.05 level.|ANCOVA|||Analysis of covariance (ANCOVA) model with treatment as a factor, baseline Hb and iron repletion status as covariates was used to compare treatments.||||0.0757
72398130|NCT01414075|144302161|OTHER|||||||0.063||||||Threshold for significance at 0.05 level.|ANCOVA|||ANCOVA model with treatment as a factor, baseline Hb and iron repletion status as covariates was used to compare treatments.||||0.0630
72506955|NCT02345161|144546047|SUPERIORITY_OR_OTHER||LS Mean difference|-0.33|STANDARD_ERROR_OF_MEAN|0.169||0.051|TWO_SIDED|95.0|-0.66|0.0|||Mixed Model Repeated Measures||Breathlessness EXACT-RS score, Week 1-4|||0.00|-0.66|0.051
72506956|NCT02345161|144546047|SUPERIORITY_OR_OTHER||LS Mean difference|-0.61|STANDARD_ERROR_OF_MEAN|0.207||0.003|TWO_SIDED|95.0|-1.02|-0.2|||Mixed Model Repeated Measures||Breathlessness EXACT-RS score, Week 5-8|||-0.20|-1.02|0.003
72506957|NCT02345161|144546047|SUPERIORITY_OR_OTHER||LS Mean difference|-0.61|STANDARD_ERROR_OF_MEAN|0.234||0.01|TWO_SIDED|95.0|-1.07|-0.15|||Mixed Model Repeated Measures||Breathlessness EXACT-RS score, Week 9-12|||-0.15|-1.07|0.010
72506958|NCT02345161|144546047|SUPERIORITY_OR_OTHER||LS Mean difference|-0.62|STANDARD_ERROR_OF_MEAN|0.247||0.013|TWO_SIDED|95.0|-1.1|-0.13|||Mixed Model Repeated Measures||Breathlessness EXACT-RS score, Week 13-16|||-0.13|-1.10|0.013
72506959|NCT02345161|144546047|SUPERIORITY_OR_OTHER||LS Mean difference|-0.67|STANDARD_ERROR_OF_MEAN|0.265||0.012|TWO_SIDED|95.0|-1.19|-0.15|||Mixed Model Repeated Measures||Breathlessness EXACT-RS score, Week 17-20|||-0.15|-1.19|0.012
72398131|NCT01414075|144302161|OTHER|||||||0.8653||||||Threshold for significance at 0.05 level.|ANCOVA|||ANCOVA model with treatment as a factor, baseline Hb and iron repletion status as covariates was used to compare treatments.||||0.8653
72473259|NCT04546425|144470468|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC-13vPnC) was greater than -10%.|Percent Difference|-17.9|||||TWO_SIDED|95.0|-23.2|-12.4|||||2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.|Serotype 3||-12.4|-23.2|
72398132|NCT01414075|144302161|OTHER|||||||0.8982||||||Threshold for significance at 0.05 level.|ANCOVA|||ANCOVA model with treatment as a factor, baseline Hb and iron repletion status as covariates was used to compare treatments.||||0.8982
72398133|NCT01340898|144302211|SUPERIORITY_OR_OTHER||Percentage of subjects|100.0|||||TWO_SIDED|95.0|98.9|100.0|||||Immunogenicity was considered demonstrated if the lower limit of the two-sided exact 95% confidence interval (CI) for the percentage of subjects with rSBA titre ≥ 1:8 was greater than or equal to the pre-defined clinical limit of 80%.|Demonstration of the immunogenicity of the Nimenrix™ conjugate vaccine in terms of bactericidal antibodies to N. meningitidis serogroup A one-month post-dose 3 of Nimenrix™ vaccine at 7 months of age in healthy infants||100|98.9|
72473260|NCT04546425|144470468|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC-13vPnC) was greater than -10%.|Percent Difference|-11.0|||||TWO_SIDED|95.0|-16.0|-5.9|||||2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.|Serotype 4||-5.9|-16.0|
72473261|NCT04546425|144470468|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC-13vPnC) was greater than -10%.|Percent Difference|-12.6|||||TWO_SIDED|95.0|-17.8|-7.2|||||2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.|Serotype 5||-7.2|-17.8|
72473262|NCT04546425|144470468|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC-13vPnC) was greater than -10%.|Percent Difference|-14.1|||||TWO_SIDED|95.0|-19.5|-8.6|||||2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.|Serotype 6A||-8.6|-19.5|
72473263|NCT04546425|144470468|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC-13vPnC) was greater than -10%.|Percent Difference|-15.8|||||TWO_SIDED|95.0|-21.0|-10.6|||||2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.|Serotype 6B||-10.6|-21.0|
72473264|NCT04546425|144470468|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC-13vPnC) was greater than -10%.|Percent Difference|-2.6|||||TWO_SIDED|95.0|-6.3|1.1|||||2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.|Serotype 7F||1.1|-6.3|
72473265|NCT04546425|144470468|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC-13vPnC) was greater than -10%.|Percent Difference|-14.3|||||TWO_SIDED|95.0|-19.7|-8.9|||||2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.|Serotype 9V||-8.9|-19.7|
72473266|NCT04546425|144470468|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC-13vPnC) was greater than -10%.|Percent Difference|-3.3|||||TWO_SIDED|95.0|-7.9|1.4|||||2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.|Serotype 14||1.4|-7.9|
72473267|NCT04546425|144470468|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC-13vPnC) was greater than -10%.|Percent Difference|-5.5|||||TWO_SIDED|95.0|-10.6|-0.4|||||2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.|Serotype 18C||-0.4|-10.6|
72473268|NCT04546425|144470468|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC-13vPnC) was greater than -10%.|Percent Difference|-1.7|||||TWO_SIDED|95.0|-4.8|1.3|||||2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.|Serotype 19A||1.3|-4.8|
72473269|NCT04546425|144470468|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC-13vPnC) was greater than -10%.|Percent Difference|-1.4|||||TWO_SIDED|95.0|-4.0|1.2|||||2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.|Serotype 19F||1.2|-4.0|
72473270|NCT04546425|144470468|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC-13vPnC) was greater than -10%.|Percent Difference|-18.3|||||TWO_SIDED|95.0|-23.6|-12.9|||||2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.|Serotype 23F||-12.9|-23.6|
72473271|NCT04546425|144470468|NON_INFERIORITY|For the additional 7 serotypes, the compared results are from serotype 6B (13vPnC serotype with the lowest percentage, not including serotype 3) in the 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC - lowest 13vPnC) was greater than -10%.|Percent difference|59.9|||||TWO_SIDED|95.0|55.6|64.1|||||2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.|Serotype 8||64.1|55.6|
72398134|NCT01340898|144302211|SUPERIORITY_OR_OTHER||Percentage of subjects|99.7|||||TWO_SIDED|95.0|98.3|100.0|||||Immunogenicity was considered demonstrated if the lower limit of the two-sided exact 95% confidence interval (CI) for the percentage of subjects with rSBA titre ≥ 1:8 was greater than or equal to the pre-defined clinical limit of 80%.|Demonstration of the immunogenicity of the Nimenrix™ conjugate vaccine in terms of bactericidal antibodies to N. meningitidis serogroup C one-month post-dose 3 of Nimenrix™ vaccine at 7 months of age in healthy infants.||100|98.3|
72398135|NCT01340898|144302211|SUPERIORITY_OR_OTHER||Percentage of subjects|99.4|||||TWO_SIDED|95.0|97.8|99.9|||||Immunogenicity was considered demonstrated if the lower limit of the two-sided exact 95% confidence interval (CI) for the percentage of subjects with rSBA titre ≥ 1:8 was greater than or equal to the pre-defined clinical limit of 80%.|Demonstration of the immunogenicity of the Nimenrix™ conjugate vaccine in terms of bactericidal antibodies to N. meningitidis serogroup W-135 one-month post-dose 3 of Nimenrix™ vaccine at 7 months of age in healthy infants||99.9|97.8|
72398136|NCT01340898|144302211|SUPERIORITY_OR_OTHER||Percentage of subjects|99.7|||||TWO_SIDED|95.0|98.3|100.0|||||Immunogenicity was considered demonstrated if the lower limit of the two-sided exact 95% confidence interval (CI) for the percentage of subjects with rSBA titre ≥ 1:8 was greater than or equal to the pre-defined clinical limit of 80%.|Demonstration of the immunogenicity of the Nimenrix™ conjugate vaccine in terms of bactericidal antibodies to N. meningitidis serogroup Y one-month post-dose 3 of Nimenrix™ vaccine at 7 months of age in healthy infants||100|98.3|
72398137|NCT00775645|144302275|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9||||0.17|TWO_SIDED|95.0|-2.2|0.4|||Regression, Linear|Linear regression model adjusted for baseline score, taxane regiment, and age.||||0.4|-2.2|0.17
72398138|NCT00775645|144302276|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2||||0.92|TWO_SIDED|95.0|-3.0|2.7|||Regression, Linear|Linear regression model adjusted for baseline score, taxane regiment, and age.||||2.7|-3|0.92
72473272|NCT04546425|144470468|NON_INFERIORITY|For the additional 7 serotypes, the compared results are from serotype 6B (13vPnC serotype with the lowest percentage, not including serotype 3) in the 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC - lowest 13vPnC) was greater than -10%.|Percent difference|-7.6|||||TWO_SIDED|95.0|-13.1|-2.1|||||2-Sided 95% CI based on the Percent difference for the difference in proportions expressed as a percentage.|Serotype 10A||-2.1|-13.1|
72473273|NCT04546425|144470468|NON_INFERIORITY|For the additional 7 serotypes, the compared results are from serotype 6B (13vPnC serotype with the lowest percentage, not including serotype 3) in the 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC - lowest 13vPnC) was greater than -10%.|Percent difference|57.6|||||TWO_SIDED|95.0|53.1|61.9|||||2-Sided 95% CI based on the Percent difference for the difference in proportions expressed as a percentage.|Serotype 11A||61.9|53.1|
72398139|NCT00775645|144302277|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.3||||0.2|TWO_SIDED|95.0|-0.7|3.3|||Regression, Linear|Linear regression model adjusted for baseline score, taxane regiment, and age.||||3.3|-0.7|0.20
72398140|NCT00775645|144302278|SUPERIORITY|||||||0.46|||||||Regression, Linear|Adjusted for randomization stratification factors.||||||0.46
72398141|NCT03194698|144302310|SUPERIORITY|||||||0.0312|||||||Wilcoxon (Mann-Whitney)|||||||0.0312
72398142|NCT03194698|144302311|SUPERIORITY|||||||0.79|||||||Wilcoxon (Mann-Whitney)|||||||0.79
72398143|NCT03194698|144302312|SUPERIORITY|||||||0.74|||||||Wilcoxon (Mann-Whitney)|||||||0.74
72398144|NCT00665847|144302318|SUPERIORITY_OR_OTHER||Proportion|52.5|STANDARD_ERROR_OF_MEAN|0.05|||TWO_SIDED|95.0|42.7|62.2|||||The standard error for a proportion was calculated as the square root of the variance divided by the number of patients. The variance for a proportion is equal to p\*(1-p), with p being the proportion.|||62.2|42.7|
72398145|NCT03388294|144302324|OTHER|The focus for this analysis is change over time|Mean Difference (Net)|7.32||||0.028|TWO_SIDED||||||Mixed Models Analysis|||||||0.028
72398146|NCT03388294|144302325|OTHER||Mean Difference (Net)|12.75|||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||The focus for this analysis is change over time||||<0.001
72398147|NCT03388294|144302326|SUPERIORITY|||||||0.87|||||||Mixed Models Analysis|||||||0.87
72398148|NCT03388294|144302327|OTHER|The focus for this analysis is change over time|Mean Difference (Net)|0.61||||0.006|TWO_SIDED||||||Mixed Models Analysis|||||||0.006
72398149|NCT03388294|144302328|SUPERIORITY|||||||0.76|||||||Mixed Models Analysis|||||||0.76
72398150|NCT03388294|144302329|OTHER|The focus for this analysis is change over time||||||0.849|||||||Mixed Models Analysis|||||||0.849
72398151|NCT03388294|144302330|OTHER|The focus for this analysis is change over time|Mean Difference (Net)|0.2||||0.063|TWO_SIDED||||||Mixed Models Analysis|||||||0.063
72398152|NCT03388294|144302331|OTHER|The focus for this analysis is change over time|Mean Difference (Net)|0.48|||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
72398153|NCT03388294|144302335|OTHER|The focus for this analysis is change over time|Mean Difference (Net)|-2.9||||0.036|TWO_SIDED||||||Mixed Models Analysis|||||||0.036
72398154|NCT03388294|144302336|OTHER|The focus for this analysis is change over time||||||0.0002|||||||Mixed Models Analysis|||||||0.0002
72398155|NCT03388294|144302337|OTHER|The focus for this analysis is change over time|Mean Difference (Net)|0.36||||0.864|TWO_SIDED||||||Mixed Models Analysis|||||||0.864
72398156|NCT03388294|144302338|OTHER|The focus for this analysis is change over time|Mean Difference (Net)|3.14||||0.12|TWO_SIDED||||||Mixed Models Analysis|||||||0.12
72398157|NCT03388294|144302339|OTHER|The focus for this analysis is change over time|Mean Difference (Net)|0.02||||0.881|TWO_SIDED||||||Mixed Models Analysis|||||||0.881
72398158|NCT03388294|144302340|OTHER|The focus for this analysis is change over time|Mean Difference (Net)|0.02||||0.846|TWO_SIDED||||||Mixed Models Analysis|||||||0.846
72398159|NCT03143569|144302348|OTHER|||||||0.45|||||||Fisher Exact|||||||.45
72398160|NCT03143569|144302349|OTHER|||||||1|||||||Fisher Exact|||||||1.0
72398161|NCT03143569|144302350|OTHER|||||||1|||||||Fisher Exact|||||||1.0
72398162|NCT03143569|144302351|OTHER|||||||1|||||||Fisher Exact|||||||1.0
72398163|NCT03143569|144302352|OTHER|||||||0.018|||||||Chi-squared|||||||.018
72398164|NCT01705288|144302357|SUPERIORITY|||||||0.36|||||||Wilcoxon (Mann-Whitney)|||Intention to Treat Analysis||||0.36
72398165|NCT01705288|144302358|SUPERIORITY|||||||0.05|||||||Wilcoxon (Mann-Whitney)|||Intention to Treat Analysis||||0.05
72473274|NCT04546425|144470468|NON_INFERIORITY|For the additional 7 serotypes, the compared results are from serotype 6B (13vPnC serotype with the lowest percentage, not including serotype 3) in the 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC - lowest 13vPnC) was greater than -10%.|Percent difference|-6.2|||||TWO_SIDED|95.0|-11.7|-0.7|||||2-Sided 95% CI based on the Percent difference for the difference in proportions expressed as a percentage.|Serotype 12F||-0.7|-11.7|
72473275|NCT04546425|144470468|NON_INFERIORITY|For the additional 7 serotypes, the compared results are from serotype 6B (13vPnC serotype with the lowest percentage, not including serotype 3) in the 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC - lowest 13vPnC) was greater than -10%.|Percent difference|57.8|||||TWO_SIDED|95.0|53.3|62.1|||||2-Sided 95% CI based on the Percent difference for the difference in proportions expressed as a percentage.|Serotype 15B||62.1|53.3|
72473276|NCT04546425|144470468|NON_INFERIORITY|For the additional 7 serotypes, the compared results are from serotype 6B (13vPnC serotype with the lowest percentage, not including serotype 3) in the 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC - lowest 13vPnC) was greater than -10%.|Percent difference|57.8|||||TWO_SIDED|95.0|53.3|62.1|||||2-Sided 95% CI based on the Percent difference for the difference in proportions expressed as a percentage.|Serotype 22F||62.1|53.3|
72506960|NCT02345161|144546047|SUPERIORITY_OR_OTHER||LS Mean difference|-0.64|STANDARD_ERROR_OF_MEAN|0.268||0.018|TWO_SIDED|95.0|-1.16|-0.11|||Mixed Model Repeated Measures||Breathlessness EXACT-RS score, Week 21-24|||-0.11|-1.16|0.018
72506961|NCT02345161|144546047|SUPERIORITY_OR_OTHER||LS Mean difference|-0.76|STANDARD_ERROR_OF_MEAN|0.275||0.006|TWO_SIDED|95.0|-1.3|-0.21|||Mixed Model Repeated Measures||Breathlessness EXACT-RS score, Week 25-28|||-0.21|-1.30|0.006
72506962|NCT02345161|144546047|SUPERIORITY_OR_OTHER||LS Mean difference|-0.85|STANDARD_ERROR_OF_MEAN|0.276||0.002|TWO_SIDED|95.0|-1.4|-0.31|||Mixed Model Repeated Measures||Breathlessness EXACT-RS score, Week 29-32|||-0.31|-1.40|0.002
72506963|NCT02345161|144546047|SUPERIORITY_OR_OTHER||LS Mean difference|-0.95|STANDARD_ERROR_OF_MEAN|0.288||0.001|TWO_SIDED|95.0|-1.51|-0.38|||Mixed Model Repeated Measures||Breathlessness EXACT-RS score, Week 33-36|||-0.38|-1.51|0.001
72506964|NCT02345161|144546047|SUPERIORITY_OR_OTHER||LS Mean difference|-0.76|STANDARD_ERROR_OF_MEAN|0.287||0.008|TWO_SIDED|95.0|-1.32|-0.2|||Mixed Model Repeated Measures||Breathlessness EXACT-RS score, Week 37-40|||-0.20|-1.32|0.008
72506965|NCT02345161|144546047|SUPERIORITY_OR_OTHER||LS Mean difference|-0.82|STANDARD_ERROR_OF_MEAN|0.294||0.006|TWO_SIDED|95.0|-1.4|-0.24|||Mixed Model Repeated Measures||Breathlessness EXACT-RS score, Week 41-44|||-0.24|-1.40|0.006
72623064|NCT04003389|144776427|SUPERIORITY||LSMean difference|0.007|STANDARD_ERROR_OF_MEAN|0.003||0.029|TWO_SIDED|95.0|0.001|0.014||The LSM, SE, CI, and p-values come from an ANCOVA model with change from baseline at the Week 52 timepoint as response, treatment and smoking status (current vs former/never) as fixed effects with baseline weight and baseline as covariates.|ANCOVA|||Hip (Femoral Neck)||0.014|0.001|0.029
72398166|NCT01705288|144302359|SUPERIORITY|||||||0.18|||||||Wilcoxon (Mann-Whitney)|||||||0.18
72473277|NCT04546425|144470468|NON_INFERIORITY|For the additional 7 serotypes, the compared results are from serotype 6B (13vPnC serotype with the lowest percentage, not including serotype 3) in the 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC - lowest 13vPnC) was greater than -10%.|Percent difference|10.3|||||TWO_SIDED|95.0|4.5|16.0|||||2-Sided 95% CI based on the Percent difference for the difference in proportions expressed as a percentage.|Serotype 33F||16.0|4.5|
72506966|NCT02345161|144546047|SUPERIORITY_OR_OTHER||LS Mean difference|-0.85|STANDARD_ERROR_OF_MEAN|0.299||0.004|TWO_SIDED|95.0|-1.44|-0.27|||Breathlessness score, Week 41-44||Breathlessness EXACT-RS score, Week 45-48|||-0.27|-1.44|0.004
72506967|NCT02345161|144546047|SUPERIORITY_OR_OTHER||LS Mean difference|-0.87|STANDARD_ERROR_OF_MEAN|0.294||0.003|TWO_SIDED|95.0|-1.45|-0.3|||Mixed Model Repeated Measures||Breathlessness EXACT-RS score, Week 49-52EXA|||-0.30|-1.45|0.003
72506968|NCT02345161|144546047|SUPERIORITY_OR_OTHER||LS Mean difference|-0.02|STANDARD_ERROR_OF_MEAN|0.091||0.84|TWO_SIDED|95.0|-0.2|0.16|||Mixed Model Repeated Measures||Cough and sputum EXACT-RS score, Week 1-4|||0.16|-0.20|0.840
72506969|NCT02345161|144546047|SUPERIORITY_OR_OTHER||LS Mean difference|-0.15|STANDARD_ERROR_OF_MEAN|0.106||0.167|TWO_SIDED|95.0|-0.36|-0.06|||Mixed Model Repeated Measures||Cough and sputum EXACT-RS score, Week 5-8|||-0.06|-0.36|0.167
72506970|NCT02345161|144546047|SUPERIORITY_OR_OTHER||LS Mean difference|-0.11|STANDARD_ERROR_OF_MEAN|0.117||0.359|TWO_SIDED|95.0|-0.34|0.12|||Mixed Model Repeated Measures||Cough and sputum EXACT-RS score, Week 9-12|||0.12|-0.34|0.359
72506971|NCT02345161|144546047|SUPERIORITY_OR_OTHER||LS Mean difference|-0.11|STANDARD_ERROR_OF_MEAN|0.124||0.36|TWO_SIDED|95.0|-0.36|0.13|||Mixed Model Repeated Measures||Cough and sputum EXACT-RS score, Week 13-16|||0.13|-0.36|0.360
72506972|NCT02345161|144546047|SUPERIORITY_OR_OTHER||LS Mean difference|-0.09|STANDARD_ERROR_OF_MEAN|0.134||0.49|TWO_SIDED|95.0|-0.36|0.17|||Mixed Model Repeated Measures||Cough and sputum EXACT-RS score, Week 17-20|||0.17|-0.36|0.490
72506973|NCT02345161|144546047|SUPERIORITY_OR_OTHER||LS Mean difference|-0.12|STANDARD_ERROR_OF_MEAN|0.138||0.388|TWO_SIDED|95.0|-0.39|0.15|||Mixed Model Repeated Measures||Cough and sputum EXACT-RS score, Week 21-24|||0.15|-0.39|0.388
72506974|NCT02345161|144546047|SUPERIORITY_OR_OTHER||LS Mean difference|-0.17|STANDARD_ERROR_OF_MEAN|0.137||0.218|TWO_SIDED|95.0|-0.44|0.1|||Mixed Model Repeated Measures||Cough and sputum EXACT-RS score, Week 25-28|||0.10|-0.44|0.218
72506975|NCT02345161|144546047|SUPERIORITY_OR_OTHER||LS Mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.136||0.138|TWO_SIDED|95.0|-0.47|0.07|||Mixed Model Repeated Measures||Cough and sputum EXACT-RS score, Week 29-32|||0.07|-0.47|0.138
72506976|NCT02345161|144546047|SUPERIORITY_OR_OTHER||LS Mean difference|-0.17|STANDARD_ERROR_OF_MEAN|0.14||0.239|TWO_SIDED|95.0|-0.44|0.11|||Mixed Model Repeated Measures||Cough and sputum EXACT-RS score, Week 33-36|||0.11|-0.44|0.239
72506977|NCT02345161|144546047|SUPERIORITY_OR_OTHER||LS Mean difference|-0.11|STANDARD_ERROR_OF_MEAN|0.138||0.417|TWO_SIDED|95.0|-0.38|0.16|||Mixed Model Repeated Measures||Cough and sputum EXACT-RS score, Week 37-40|||0.16|-0.38|0.417
72506978|NCT02345161|144546047|SUPERIORITY_OR_OTHER||LS Mean difference|-0.25|STANDARD_ERROR_OF_MEAN|0.144||0.078|TWO_SIDED|95.0|-0.54|0.03|||Mixed Model Repeated Measures||Cough and sputum EXACT-RS score, Week 41-44|||0.03|-0.54|0.078
72506979|NCT02345161|144546047|SUPERIORITY_OR_OTHER||LS Mean difference|-0.27|STANDARD_ERROR_OF_MEAN|0.14||0.058|TWO_SIDED|95.0|-0.54|0.01|||Mixed Model Repeated Measures||Cough and sputum EXACT-RS score, Week 45-48|||0.01|-0.54|0.058
72506980|NCT02345161|144546047|SUPERIORITY_OR_OTHER||LS Mean difference|-0.17|STANDARD_ERROR_OF_MEAN|0.141||0.231|TWO_SIDED|95.0|-0.45|0.11|||Mixed Model Repeated Measures||Cough and sputum EXACT-RS score, Week 49-52|||0.11|-0.45|0.231
72506981|NCT02345161|144546047|SUPERIORITY_OR_OTHER||LS Mean difference|-0.18|STANDARD_ERROR_OF_MEAN|0.097||0.068|TWO_SIDED|95.0|-0.37|0.01|||Mixed Model Repeated Measures||Chest EXACT-RS score, Week 1-4|||0.01|-0.37|0.068
72506982|NCT02345161|144546047|SUPERIORITY_OR_OTHER||LS Mean difference|-0.32|STANDARD_ERROR_OF_MEAN|0.118||0.006|TWO_SIDED|95.0|-0.56|-0.09|||Mixed Model Repeated Measures||Chest EXACT-RS score, Week 5-8|||-0.09|-0.56|0.006
72506983|NCT02345161|144546047|SUPERIORITY_OR_OTHER||LS Mean difference|-0.27|STANDARD_ERROR_OF_MEAN|0.131||0.042|TWO_SIDED|95.0|-0.53|-0.01|||Mixed Model Repeated Measures||Chest EXACT-RS score, Week 9-12|||-0.01|-0.53|0.042
72506984|NCT02345161|144546047|SUPERIORITY_OR_OTHER||LS Mean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.136||0.027|TWO_SIDED|95.0|-0.57|-0.03|||Mixed Model Repeated Measures||Chest EXACT-RS score, Week 13-16|||-0.03|-0.57|0.027
72506985|NCT02345161|144546047|SUPERIORITY_OR_OTHER||LS Mean difference|-0.38|STANDARD_ERROR_OF_MEAN|0.146||0.01|TWO_SIDED|95.0|-0.67|-0.09|||Mixed Model Repeated Measures||Chest EXACT-RS score, Week 17-20|||-0.09|-0.67|0.010
72506986|NCT02345161|144546047|SUPERIORITY_OR_OTHER||LS Mean difference|-0.37|STANDARD_ERROR_OF_MEAN|0.144||0.01|TWO_SIDED|95.0|-0.66|-0.09|||Mixed Model Repeated Measures||Chest EXACT-RS score, Week 21-24|||-0.09|-0.66|0.010
72506987|NCT02345161|144546047|SUPERIORITY_OR_OTHER||LS Mean difference|-0.41|STANDARD_ERROR_OF_MEAN|0.148|||TWO_SIDED|95.0|-0.7|-0.12|||Mixed Model Repeated Measures||Chest EXACT-RS score, Week 25-28|||-0.12|-0.70|
72398167|NCT00613938|144302387|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|62.4|STANDARD_ERROR_OF_MEAN|11.9|<|0.001||95.0|39.01|85.73||Comparisons of tapentadol dose groups and placebo was performed with Hochberg procedure for adjustment for the multiple tests.|ANCOVA||The results shown are the treatment group differences between Tapentadol IR 50mg group and placebo.|Null hypothesis: There are no differences in pain intensity measured by SPID-48 hours between any of tapentadol dose groups and placebo. ANCOVA model with factors of treatment, center and baseline pain intensity score was used for the primary analysis.||85.73|39.01|<0.001
72506988|NCT02345161|144546047|SUPERIORITY_OR_OTHER||LS Mean difference|-0.39|STANDARD_ERROR_OF_MEAN|0.152||0.011|TWO_SIDED|95.0|-0.68|-0.09|||Mixed Model Repeated Measures||Chest EXACT-RS score, Week 29-32|||-0.09|-0.68|0.011
72506989|NCT02345161|144546047|SUPERIORITY_OR_OTHER||LS Mean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.157||0.011|TWO_SIDED|95.0|-0.71|-0.09|||Mixed Model Repeated Measures||Chest EXACT-RS score, Week 33-36|||-0.09|-0.71|0.011
72506990|NCT02345161|144546047|SUPERIORITY_OR_OTHER||LS Mean difference|-0.37|STANDARD_ERROR_OF_MEAN|0.151||0.014|TWO_SIDED|95.0|-0.67|-0.07|||Mixed Model Repeated Measures||Chest EXACT-RS score, Week 37-40|||-0.07|-0.67|0.014
72506991|NCT02345161|144546047|SUPERIORITY_OR_OTHER||LS Mean difference|-0.42|STANDARD_ERROR_OF_MEAN|0.153||0.007|TWO_SIDED|95.0|-0.72|-0.12|||Mixed Model Repeated Measures||Chest EXACT-RS score, Week 41-44|||-0.12|-0.72|0.007
72506992|NCT02345161|144546047|SUPERIORITY_OR_OTHER||LS Mean difference|-0.45|STANDARD_ERROR_OF_MEAN|0.16||0.006|TWO_SIDED|95.0|-0.76|-0.13|||Mixed Model Repeated Measures||Chest EXACT-RS score, Week 45-48|||-0.13|-0.76|0.006
72506993|NCT02345161|144546047|SUPERIORITY_OR_OTHER||LS Mean difference|-0.41|STANDARD_ERROR_OF_MEAN|0.163||0.013|TWO_SIDED|95.0|-0.73|-0.09|||Mixed Model Repeated Measures||Chest EXACT-RS score, Week 49-52|||-0.09|-0.73|0.013
72506994|NCT02345161|144546056|SUPERIORITY_OR_OTHER||LS mean difference|1.8|STANDARD_ERROR_OF_MEAN|0.81||0.023|TWO_SIDED|95.0|0.3|3.4|||Mixed Model Repeated Measures||For QTcF|||3.4|0.3|0.023
72506995|NCT02345161|144546056|SUPERIORITY_OR_OTHER||LS mean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.78||0.471|TWO_SIDED|95.0|-2.1|1.0|||Mixed Model Repeated Measures||For PR interval|||1.0|-2.1|0.471
72506996|NCT02345161|144546057|SUPERIORITY_OR_OTHER||LS mean difference|-1.1|STANDARD_ERROR_OF_MEAN|1.83||0.564|TWO_SIDED|95.0|-4.7|2.5|||Mixed Model Repeated Measures||For QTcF|||2.5|-4.7|0.564
72506997|NCT02345161|144546057|SUPERIORITY_OR_OTHER||LS mean difference|0.2|STANDARD_ERROR_OF_MEAN|1.57||0.908|TWO_SIDED|95.0|-2.9|3.3|||Mixed Model Repeated Measures||For PR interval|||3.3|-2.9|0.908
72506998|NCT02345161|144546060|SUPERIORITY_OR_OTHER||LS mean difference|0.1|STANDARD_ERROR_OF_MEAN|0.56||0.849|TWO_SIDED|95.0|-1.0|1.2|||Mixed Model Repeated Measures||Week 24, SBP|||1.2|-1.0|0.849
72506999|NCT02345161|144546060|SUPERIORITY_OR_OTHER||LS mean difference|0.2|STANDARD_ERROR_OF_MEAN|0.38||0.613|TWO_SIDED|95.0|-0.6|0.9|||Mixed Model Repeated Measures||Week 24, DBP|||0.9|-0.6|0.613
72507000|NCT02345161|144546061|SUPERIORITY_OR_OTHER||: LS mean difference|-1.6|STANDARD_ERROR_OF_MEAN|1.19||0.183|TWO_SIDED|95.0|-3.9|0.8|||Mixed Model Repeated Measures||Week 52, SBP|||0.8|-3.9|0.183
72507001|NCT02345161|144546061|SUPERIORITY_OR_OTHER||LS mean difference|-0.9|STANDARD_ERROR_OF_MEAN|0.75||0.253|TWO_SIDED|95.0|-2.3|0.6|||Mixed Model Repeated Measures||Week 52, DBP|||0.6|-2.3|0.253
72507002|NCT02345161|144546063|SUPERIORITY_OR_OTHER||LS mean difference|0.3|STANDARD_ERROR_OF_MEAN|0.45||0.526|TWO_SIDED|95.0|-0.6|1.2|||Mixed Model Repeated Measures|||||1.2|-0.6|0.526
72507003|NCT02345161|144546064|SUPERIORITY_OR_OTHER||LS mean difference|2.6|STANDARD_ERROR_OF_MEAN|0.96||0.007|TWO_SIDED|95.0|0.7|4.5|||Mixed Model Repeated Measures|||||4.5|0.7|0.007
72507004|NCT02606045|144546088|SUPERIORITY||Mean Difference (Final Values)|46.0||||0.039|TWO_SIDED|95.0|2.0|90.0|||Mixed Models Analysis|||||90|2|0.039
72507005|NCT02606045|144546089|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.998|TWO_SIDED|95.0|-0.7|0.7|||Mixed Models Analysis|||||0.7|-0.7|0.998
72507006|NCT02606045|144546090|SUPERIORITY||Mean Difference (Final Values)|2.4||||0.168|TWO_SIDED|95.0|-1.0|5.8|||Mixed Models Analysis|||||5.8|-1.0|0.168
72507007|NCT02606045|144546091|SUPERIORITY||Mean Difference (Final Values)|-2.5||||0.055|TWO_SIDED|95.0|-4.9|0.1|||Mixed Models Analysis|||||0.1|-4.9|0.055
72507008|NCT02606045|144546092|SUPERIORITY||Mean Difference (Final Values)|-0.8||||0.681|TWO_SIDED|95.0|-4.8|3.2|||Mixed Models Analysis|||||3.2|-4.8|0.681
72507009|NCT02606045|144546092|SUPERIORITY||Mean Difference (Final Values)|-2.4||||0.633|TWO_SIDED|95.0|-12.4|7.6|||Mixed Models Analysis|||Role limitations of physical health||7.6|-12.4|0.633
72507010|NCT02606045|144546092|SUPERIORITY||Mean Difference (Final Values)|4.8||||0.362|TWO_SIDED|95.0|-5.7|15.3|||Mixed Models Analysis|||Role limitations of emotional health||15.3|-5.7|0.362
72473278|NCT04546425|144470469|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|0.61|||||TWO_SIDED|95.0|0.54|0.69|||||2-sided 95% CI was calculated by exponentiating the CI (based on the Student's t distribution) for the mean difference of the logarithm of the concentrations.|Serotype 1||0.69|0.54|
72473279|NCT04546425|144470469|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|0.71|||||TWO_SIDED|95.0|0.64|0.79|||||2-sided 95% CI was calculated by exponentiating the CI (based on the Student's t distribution) for the mean difference of the logarithm of the concentrations.|Serotype 3||0.79|0.64|
72473280|NCT04546425|144470469|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|0.6|||||TWO_SIDED|95.0|0.52|0.69|||||2-sided 95% CI was calculated by exponentiating the CI (based on the Student's t distribution) for the mean difference of the logarithm of the concentrations.|Serotype 4||0.69|0.52|
72473281|NCT04546425|144470469|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|0.6|||||TWO_SIDED|95.0|0.52|0.7|||||2-sided 95% CI was calculated by exponentiating the CI (based on the Student's t distribution) for the mean difference of the logarithm of the concentrations.|Serotype 5||0.70|0.52|
72473282|NCT04546425|144470469|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|0.54|||||TWO_SIDED|95.0|0.45|0.65|||||2-sided 95% CI was calculated by exponentiating the CI (based on the Student's t distribution) for the mean difference of the logarithm of the concentrations.|Serotype 6A||0.65|0.45|
72473283|NCT04546425|144470469|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|0.51|||||TWO_SIDED|95.0|0.43|0.61|||||2-sided 95% CI was calculated by exponentiating the CI (based on the Student's t distribution) for the mean difference of the logarithm of the concentrations.|Serotype 6B||0.61|0.43|
72473284|NCT04546425|144470469|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|0.72|||||TWO_SIDED|95.0|0.64|0.8|||||2-sided 95% CI was calculated by exponentiating the CI (based on the Student's t distribution) for the mean difference of the logarithm of the concentrations.|Serotype 7F||0.80|0.64|
72473285|NCT04546425|144470469|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|0.59|||||TWO_SIDED|95.0|0.5|0.69|||||2-sided 95% CI was calculated by exponentiating the CI (based on the Student's t distribution) for the mean difference of the logarithm of the concentrations.|Serotype 9V||0.69|0.50|
72507011|NCT02606045|144546092|SUPERIORITY||Mean Difference (Final Values)|-2.3||||0.375|TWO_SIDED|95.0|-7.4|2.8|||Mixed Models Analysis|||Energy/fatigue||2.8|-7.4|0.375
72398168|NCT02636868|144302393|SUPERIORITY|||||||0.363||||||a priori threshold of statistical significance set at 0.05|Regression, Logistic|Pooled site, treatment, gender, birth weight, and baseline fraction of inspired oxygen (FiO₂) in model||Null hypothesis is no difference across treatment groups||||0.363
72398169|NCT02636868|144302393|SUPERIORITY|||||||0.36||||||a priori threshold of statistical significance set at 0.05|Regression, Logistic|Pooled site, treatment, gender, birth weight, and baseline FiO₂ in model||Null hypothesis of no difference between treatments||||0.360
72473286|NCT04546425|144470469|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|0.82|||||TWO_SIDED|95.0|0.7|0.96|||||2-sided 95% CI was calculated by exponentiating the CI (based on the Student's t distribution) for the mean difference of the logarithm of the concentrations.|Serotype 14||0.96|0.70|
72473287|NCT04546425|144470469|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|0.79|||||TWO_SIDED|95.0|0.67|0.92|||||2-sided 95% CI was calculated by exponentiating the CI (based on the Student's t distribution) for the mean difference of the logarithm of the concentrations.|Serotype 18C||0.92|0.67|
72473288|NCT04546425|144470469|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|0.59|||||TWO_SIDED|95.0|0.51|0.69|||||2-sided 95% CI was calculated by exponentiating the CI (based on the Student's t distribution) for the mean difference of the logarithm of the concentrations.|Serotype 19A||0.69|0.51|
72507012|NCT02606045|144546092|SUPERIORITY||Mean Difference (Final Values)|3.6||||0.068|TWO_SIDED|95.0|-0.3|7.4|||Mixed Models Analysis|||Emotional well-being||7.4|-0.3|0.068
72507013|NCT02606045|144546092|SUPERIORITY||Mean Difference (Final Values)|4.5||||0.189|TWO_SIDED|95.0|-2.3|11.3|||Mixed Models Analysis|||Social functioning||11.3|-2.3|0.189
72507014|NCT02606045|144546092|SUPERIORITY||Mean Difference (Final Values)|-2.4||||0.489|TWO_SIDED|95.0|-9.2|4.5|||Mixed Models Analysis|||Pain||4.5|-9.2|0.489
72507015|NCT02606045|144546092|SUPERIORITY||Mean Difference (Final Values)|0.5||||0.786|TWO_SIDED|95.0|-3.2|4.3|||Mixed Models Analysis|||General Health||4.3|-3.2|0.786
72398170|NCT02636868|144302393|SUPERIORITY|||||||0.461||||||a priori threshold of statistical significance set at 0.05|Regression, Logistic|Pooled site, treatment, gender, birth weight, and baseline FiO₂ in model||Null hypothesis of no difference between treatments||||0.461
72473289|NCT04546425|144470469|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|0.72|||||TWO_SIDED|95.0|0.64|0.82|||||2-sided 95% CI was calculated by exponentiating the CI (based on the Student's t distribution) for the mean difference of the logarithm of the concentrations.|Serotype 19F||0.82|0.64|
72473290|NCT04546425|144470469|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|0.52|||||TWO_SIDED|95.0|0.44|0.62|||||2-sided 95% CI was calculated by exponentiating the CI (based on the Student's t distribution) for the mean difference of the logarithm of the concentrations.|Serotype 23F||0.62|0.44|
72473291|NCT04546425|144470469|NON_INFERIORITY|For the additional 7 serotypes, the compared results are from serotype 6B (13vPnC serotype with the lowest GMC, not including serotype 3) in the 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/lowest 13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|26.55|||||TWO_SIDED|95.0|22.98|30.67|||||2-sided 95% CI was calculated by exponentiating the CI (based on the Student's t distribution) for the mean difference of the logarithm of the concentrations.|Serotype 8||30.67|22.98|
72473292|NCT04546425|144470469|NON_INFERIORITY|For the additional 7 serotypes, the compared results are from serotype 6B (13vPnC serotype with the lowest GMC, not including serotype 3) in the 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/lowest 13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|2.67|||||TWO_SIDED|95.0|2.25|3.17|||||2-sided 95% CI was calculated by exponentiating the CI (based on the Student's t distribution) for the mean difference of the logarithm of the concentrations.|Serotype 10A||3.17|2.25|
72473293|NCT04546425|144470469|NON_INFERIORITY|For the additional 7 serotypes, the compared results are from serotype 6B (13vPnC serotype with the lowest GMC, not including serotype 3) in the 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/lowest 13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|26.6|||||TWO_SIDED|95.0|22.95|30.82|||||2-sided 95% CI was calculated by exponentiating the CI (based on the Student's t distribution) for the mean difference of the logarithm of the concentrations.|Serotype 11A||30.82|22.95|
72473294|NCT04546425|144470469|NON_INFERIORITY|For the additional 7 serotypes, the compared results are from serotype 6B (13vPnC serotype with the lowest GMC, not including serotype 3) in the 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/lowest 13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|2.48|||||TWO_SIDED|95.0|2.08|2.97|||||2-sided 95% CI was calculated by exponentiating the CI (based on the Student's t distribution) for the mean difference of the logarithm of the concentrations.|Serotype 12F||2.97|2.08|
72473295|NCT04546425|144470469|NON_INFERIORITY|For the additional 7 serotypes, the compared results are from serotype 6B (13vPnC serotype with the lowest GMC, not including serotype 3) in the 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/lowest 13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|54.6|||||TWO_SIDED|95.0|46.35|64.3|||||2-sided 95% CI was calculated by exponentiating the CI (based on the Student's t distribution) for the mean difference of the logarithm of the concentrations.|Serotype 15B||64.30|46.35|
72473296|NCT04546425|144470469|NON_INFERIORITY|For the additional 7 serotypes, the compared results are from serotype 6B (13vPnC serotype with the lowest GMC, not including serotype 3) in the 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/lowest 13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|36.8|||||TWO_SIDED|95.0|31.57|42.89|||||2-sided 95% CI was calculated by exponentiating the CI (based on the Student's t distribution) for the mean difference of the logarithm of the concentrations.|Serotype 22F||42.89|31.57|
72473297|NCT04546425|144470469|NON_INFERIORITY|For the additional 7 serotypes, the compared results are from serotype 6B (13vPnC serotype with the lowest GMC, not including serotype 3) in the 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/lowest 13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|5.03|||||TWO_SIDED|95.0|4.27|5.92|||||2-sided 95% CI was calculated by exponentiating the CI (based on the Student's t distribution) for the mean difference of the logarithm of the concentrations.|Serotype 33F||5.92|4.27|
72473298|NCT04546425|144470470|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|0.67|||||TWO_SIDED|95.0|0.6|0.75|||||2-sided 95% CI was calculated by exponentiating the CI (based on the Student's t distribution) for the mean difference of the logarithm of the concentrations.|Serotype 1||0.75|0.60|
72473299|NCT04546425|144470470|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|0.66|||||TWO_SIDED|95.0|0.59|0.73|||||2-sided 95% CI was calculated by exponentiating the CI (based on the Student's t distribution) for the mean difference of the logarithm of the concentrations.|Serotype 3||0.73|0.59|
72473300|NCT04546425|144470470|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|0.77|||||TWO_SIDED|95.0|0.68|0.87|||||2-sided 95% CI was calculated by exponentiating the CI (based on the Student's t distribution) for the mean difference of the logarithm of the concentrations.|Serotype 4||0.87|0.68|
72507016|NCT02606045|144546093|SUPERIORITY||Mean Difference (Final Values)|-1.0||||0.098|TWO_SIDED|95.0|-2.3|0.2|||Mixed Models Analysis|||Physically Unhealthy Days||0.2|-2.3|0.098
72507017|NCT02606045|144546093|SUPERIORITY||Mean Difference (Final Values)|0.7||||0.557|TWO_SIDED|95.0|-1.6|3.0|||Mixed Models Analysis|||Mentally Unhealthy Days||3.0|-1.6|0.557
72507018|NCT02606045|144546094|SUPERIORITY||Mean Difference (Final Values)|1.4||||0.266|TWO_SIDED|95.0|0.8|2.7|||Mixed Models Analysis|||Cycle Severity Rating||2.7|0.8|0.266
72398171|NCT02636868|144302394|SUPERIORITY|||||||0.401||||||a priori threshold of statistical significance set at 0.05|Regression, Logistic|Pooled site, treatment, gender, birth weight, and baseline FiO₂ in model||Null hypothesis is no difference across treatment groups||||0.401
72623065|NCT04003389|144776427|SUPERIORITY||LSMean difference|0.001|STANDARD_ERROR_OF_MEAN|0.003||0.867|TWO_SIDED|95.0|-0.006|0.007||The LSM, SE, CI, and p-values come from an ANCOVA model with change from baseline at the Week 52 timepoint as response, treatment and smoking status (current vs former/never) as fixed effects with baseline weight and baseline as covariates.|ANCOVA|||Hip (Femoral Neck)||0.007|-0.006|0.867
72473301|NCT04546425|144470470|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|0.72|||||TWO_SIDED|95.0|0.64|0.81|||||2-sided 95% CI was calculated by exponentiating the CI (based on the Student's t distribution) for the mean difference of the logarithm of the concentrations.|Serotype 5||0.81|0.64|
72623066|NCT04003389|144776427|SUPERIORITY||LSMean difference|0.006|STANDARD_ERROR_OF_MEAN|0.003||0.027|TWO_SIDED|95.0|0.001|0.012||The LSM, SE, CI, and p-values come from an ANCOVA model with change from baseline at the Week 52 timepoint as response, treatment and smoking status (current vs former/never) as fixed effects with baseline weight and baseline as covariates.|ANCOVA|||Hip (Femur)||0.012|0.001|0.027
72623067|NCT04003389|144776427|SUPERIORITY||LSMean difference|0.002|STANDARD_ERROR_OF_MEAN|0.003||0.41|TWO_SIDED|95.0|-0.003|0.008||The LSM, SE, CI, and p-values come from an ANCOVA model with change from baseline at the Week 52 timepoint as response, treatment and smoking status (current vs former/never) as fixed effects with baseline weight and baseline as covariates.|ANCOVA|||Hip (Femur)||0.008|-0.003|0.410
72473302|NCT04546425|144470470|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|0.66|||||TWO_SIDED|95.0|0.57|0.75|||||2-sided 95% CI was calculated by exponentiating the CI (based on the Student's t distribution) for the mean difference of the logarithm of the concentrations.|Serotype 6A||0.75|0.57|
72473303|NCT04546425|144470470|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|0.57|||||TWO_SIDED|95.0|0.48|0.67|||||2-sided 95% CI was calculated by exponentiating the CI (based on the Student's t distribution) for the mean difference of the logarithm of the concentrations.|Serotype 6B||0.67|0.48|
72473304|NCT04546425|144470470|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|0.73|||||TWO_SIDED|95.0|0.67|0.8|||||2-sided 95% CI was calculated by exponentiating the CI (based on the Student's t distribution) for the mean difference of the logarithm of the concentrations.|Serotype 7F||0.80|0.67|
72473305|NCT04546425|144470470|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|0.73|||||TWO_SIDED|95.0|0.66|0.81|||||2-sided 95% CI was calculated by exponentiating the CI (based on the Student's t distribution) for the mean difference of the logarithm of the concentrations.|Serotype 9V||0.81|0.66|
72473306|NCT04546425|144470470|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|0.8|||||TWO_SIDED|95.0|0.69|0.92|||||2-sided 95% CI was calculated by exponentiating the CI (based on the Student's t distribution) for the mean difference of the logarithm of the concentrations.|Serotype 14||0.92|0.69|
72398172|NCT02636868|144302394|SUPERIORITY|||||||0.372||||||a priori threshold of statistical significance set at 0.05|Regression, Logistic|Pooled site, treatment, gender, birth weight, and baseline FiO₂ in model||Null hypothesis is no difference across treatment groups||||0.372
72473307|NCT04546425|144470470|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|0.75|||||TWO_SIDED|95.0|0.67|0.84|||||2-sided 95% CI was calculated by exponentiating the CI (based on the Student's t distribution) for the mean difference of the logarithm of the concentrations.|Serotype 18C||0.84|0.67|
72473308|NCT04546425|144470470|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|0.82|||||TWO_SIDED|95.0|0.72|0.93|||||2-sided 95% CI was calculated by exponentiating the CI (based on the Student's t distribution) for the mean difference of the logarithm of the concentrations.|Serotype 19A||0.93|0.72|
72473309|NCT04546425|144470470|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|0.77|||||TWO_SIDED|95.0|0.68|0.87|||||2-sided 95% CI was calculated by exponentiating the CI (based on the Student's t distribution) for the mean difference of the logarithm of the concentrations.|Serotype 19F||0.87|0.68|
72507019|NCT00907881|144546095|SUPERIORITY_OR_OTHER|||||||0.0002|||||||Regression, Linear|Pearson correlation coefficient||||||0.0002
72623068|NCT04003389|144776427|SUPERIORITY||LSMean difference|0.005|STANDARD_ERROR_OF_MEAN|0.003||0.087||95.0|-0.001|0.011||The LSM, SE, CI, and p-values come from an ANCOVA model with change from baseline at the Week 52 timepoint as response, treatment and smoking status (current vs former/never) as fixed effects with baseline weight and baseline as covariates.|ANCOVA|||Hip (Trochanter)||0.011|-0.001|0.087
72398173|NCT02636868|144302394|SUPERIORITY|||||||0.648||||||a priori threshold of statistical significance set at 0.05|Regression, Logistic|Pooled site, treatment, gender, birth weight, and baseline FiO₂ in model||Null hypothesis is no difference across treatment groups||||0.648
72623069|NCT04003389|144776427|SUPERIORITY||LSMean difference|0.003|STANDARD_ERROR_OF_MEAN|0.003||0.259||95.0|-0.002|0.009||The LSM, SE, CI, and p-values come from an ANCOVA model with change from baseline at the Week 52 timepoint as response, treatment and smoking status (current vs former/never) as fixed effects with baseline weight and baseline as covariates.|ANCOVA|||Hip (Trochanter)||0.009|-0.002|0.259
72565834|NCT02709486|144662707|SUPERIORITY||Least Square Mean Difference|-6.18|STANDARD_ERROR_OF_MEAN|1.61||0.0001|TWO_SIDED|95.0|-9.34|-3.03|||ANCOVA|||Week 8: Percent Activity Impairment: WPAI parameters were analyzed using ANCOVA model which included covariates of the corresponding baseline score, baseline diary average pain, index joint, highest Kellgren-Lawrence grade (2, 3 or 4), and treatment, with study site as a random effect.||-3.03|-9.34|0.0001
72473310|NCT04546425|144470470|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|0.6|||||TWO_SIDED|95.0|0.52|0.69|||||2-sided 95% CI was calculated by exponentiating the CI (based on the Student's t distribution) for the mean difference of the logarithm of the concentrations.|Serotype 23F||0.69|0.52|
72473311|NCT04546425|144470470|NON_INFERIORITY|For the additional 7 serotypes, the compared results are from serotype 5 (13vPnC serotype with the lowest GMC, not including serotype 3) in the 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/lowest 13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|1.48|||||TWO_SIDED|95.0|1.32|1.66|||||2-sided 95% CI was calculated by exponentiating the CI (based on the Student's t distribution) for the mean difference of the logarithm of the concentrations.|Serotype 8||1.66|1.32|
72473312|NCT04546425|144470470|NON_INFERIORITY|For the additional 7 serotypes, the compared results are from serotype 5 (13vPnC serotype with the lowest GMC, not including serotype 3) in the 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/lowest 13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|2.02|||||TWO_SIDED|95.0|1.77|2.3|||||2-sided 95% CI was calculated by exponentiating the CI (based on the Student's t distribution) for the mean difference of the logarithm of the concentrations.|Serotype 10A||2.30|1.77|
72473313|NCT04546425|144470470|NON_INFERIORITY|For the additional 7 serotypes, the compared results are from serotype 5 (13vPnC serotype with the lowest GMC, not including serotype 3) in the 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/lowest 13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|1.55|||||TWO_SIDED|95.0|1.37|1.75|||||2-sided 95% CI was calculated by exponentiating the CI (based on the Student's t distribution) for the mean difference of the logarithm of the concentrations.|Serotype 11A||1.75|1.37|
72473314|NCT04546425|144470470|NON_INFERIORITY|For the additional 7 serotypes, the compared results are from serotype 5 (13vPnC serotype with the lowest GMC, not including serotype 3) in the 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/lowest 13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|0.77|||||TWO_SIDED|95.0|0.68|0.87|||||2-sided 95% CI was calculated by exponentiating the CI (based on the Student's t distribution) for the mean difference of the logarithm of the concentrations.|Serotype 12F||0.87|0.68|
72473315|NCT04546425|144470470|NON_INFERIORITY|For the additional 7 serotypes, the compared results are from serotype 5 (13vPnC serotype with the lowest GMC, not including serotype 3) in the 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/lowest 13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|5.42|||||TWO_SIDED|95.0|4.82|6.1|||||2-sided 95% CI was calculated by exponentiating the CI (based on the Student's t distribution) for the mean difference of the logarithm of the concentrations.|Serotype 15B||6.10|4.82|
72473316|NCT04546425|144470470|NON_INFERIORITY|For the additional 7 serotypes, the compared results are from serotype 5 (13vPnC serotype with the lowest GMC, not including serotype 3) in the 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/lowest 13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|3.84|||||TWO_SIDED|95.0|3.4|4.34|||||2-sided 95% CI was calculated by exponentiating the CI (based on the Student's t distribution) for the mean difference of the logarithm of the concentrations.|Serotype 22F||4.34|3.40|
72473317|NCT04546425|144470470|NON_INFERIORITY|For the additional 7 serotypes, the compared results are from serotype 5 (13vPnC serotype with the lowest GMC, not including serotype 3) in the 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/lowest 13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|2.64|||||TWO_SIDED|95.0|2.33|2.99|||||2-sided 95% CI was calculated by exponentiating the CI (based on the Student's t distribution) for the mean difference of the logarithm of the concentrations.|Serotype 33F||2.99|2.33|
72507020|NCT03408873|144546106|OTHER||Mean Difference (Final Values)|-31.4|||<|0.001|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||We compared the repeated measure outcome across 2 time-points (difference between screen \& week 24 to determine whether the population medians differed matched on participant with complete data. Of the 29 participants with screen data only 11 had Week 24 data. Statistical Analysis was conducted for 11 participants with data at the 2 timepoints. Thus, the mean difference reported is not consistent with the mean values reported because only those with complete data were included in the analysis.||||<0.001
72473318|NCT04546425|144470471|NON_INFERIORITY|Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC -13vPnC) was greater than -10%.|Percent difference|-0.2|||||TWO_SIDED|95.0|-1.3|0.8|||||2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions (20vPnc - 13vPnC) expressed as a percentage.|Diphtheria||0.8|-1.3|
72473319|NCT04546425|144470471|NON_INFERIORITY|Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC-13vPnC) was greater than -10%.|Percent difference|-0.6|||||TWO_SIDED|95.0|-1.8|0.2|||||2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions (20vPnc - 13vPnC) expressed as a percentage.|Tetanus||0.2|-1.8|
72398174|NCT02636868|144302395|SUPERIORITY|||||||0.996||||||a priori threshold of statistical significance set at 0.05|Log Rank|||Null hypothesis of no difference across treatments||||0.996
72565835|NCT02709486|144662707|SUPERIORITY||Least Square Mean Difference|-9.13|STANDARD_ERROR_OF_MEAN|1.6|<|0.0001|TWO_SIDED|95.0|-12.26|-6.0|||ANCOVA|||Week 8: Percent Activity Impairment: WPAI parameters were analyzed using ANCOVA model which included covariates of the corresponding baseline score, baseline diary average pain, index joint, highest Kellgren-Lawrence grade (2, 3 or 4), and treatment, with study site as a random effect.||-6.00|-12.26|<.0001
72623070|NCT04003389|144776428|SUPERIORITY||LSMean difference|0.048|STANDARD_ERROR_OF_MEAN|0.027||0.079|TWO_SIDED|95.0|-0.006|0.102||The LSM, SE, CI, and p-values come from an ANCOVA model with change from baseline at the Week 52 timepoint as response, treatment and smoking status (current vs former/never) as fixed effects with baseline weight and baseline as covariates.|ANCOVA|||Hip (Femoral Neck)||0.102|-0.006|0.079
72398175|NCT02636868|144302395|SUPERIORITY|||||||0.951||||||a priori threshold of statistical significance set at 0.05|Log Rank|||Null hypothesis of no difference between treatments||||0.951
72398176|NCT02636868|144302395|SUPERIORITY|||||||0.995||||||a priori threshold of statistical significance set at 0.05|Log Rank|||Null hypothesis of no difference between treatments||||0.995
72473320|NCT04546425|144470471|NON_INFERIORITY|Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC-13vPnC) was greater than -10%.|Percent difference|-2.3|||||TWO_SIDED|95.0|-5.3|0.7|||||2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.|PT||0.7|-5.3|
72473321|NCT04546425|144470471|NON_INFERIORITY|Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC-13vPnC) was greater than -10%.|Percent difference|0.2|||||TWO_SIDED|95.0|-2.6|2.9|||||2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.|FHA||2.9|-2.6|
72473322|NCT04546425|144470471|NON_INFERIORITY|Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC-13vPnC) was greater than -10%.|Percent difference|1.6|||||TWO_SIDED|95.0|-0.9|4.2|||||2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.|PRN||4.2|-0.9|
72473323|NCT04546425|144470471|NON_INFERIORITY|Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC-13vPnC) was greater than -10%.|Percent difference|1.1|||||TWO_SIDED|95.0|-1.1|4.0|||||2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions (20vPnc - 13vPnC) expressed as a percentage.|Hepatitis B||4.0|-1.1|
72473324|NCT04546425|144470471|NON_INFERIORITY|Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC -13vPnC) was greater than -10%.|Percent difference|0.0|||||TWO_SIDED|95.0|-4.6|4.2|||||2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions (20vPnc - 13vPnC) expressed as a percentage.|Poliovirus Type 1||4.2|-4.6|
72473325|NCT04546425|144470471|NON_INFERIORITY|Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC-13vPnC) was greater than -10%.|Percent difference|0.0|||||TWO_SIDED|95.0|-4.6|4.2|||||2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions (20vPnc - 13vPnC) expressed as a percentage.|Poliovirus Type 2||4.2|-4.6|
72473326|NCT04546425|144470471|NON_INFERIORITY|Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC-13vPnC) was greater than -10%.|Percent difference|0.0|||||TWO_SIDED|95.0|-4.6|4.2|||||2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions (20vPnc - 13vPnC) expressed as a percentage.|Poliovirus Type 3||4.2|-4.6|
72473327|NCT04546425|144470471|NON_INFERIORITY|Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC-13vPnC) was greater than -10%.|Percent difference|0.0|||||TWO_SIDED|95.0|-2.0|2.2|||||2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions (20vPnc - 13vPnC) expressed as a percentage.|Hib||2.2|-2.0|
72473328|NCT04546425|144470472|NON_INFERIORITY|Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|1.05|||||TWO_SIDED|95.0|0.79|1.42|||||GMR and 2-sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the concentrations (20vPnC - 13vPnC) and the corresponding CIs (based on the Student's t distribution).|Measles||1.42|0.79|
72473329|NCT04546425|144470473|NON_INFERIORITY|Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|1.04|||||TWO_SIDED|95.0|0.76|1.44|||||GMR and 2-sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the concentrations (20vPnC - 13vPnC) and the corresponding CIs (based on the Student's t distribution).|Mumps||1.44|0.76|
72473330|NCT04546425|144470474|NON_INFERIORITY|Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|0.83|||||TWO_SIDED|95.0|0.63|1.1|||||GMR and 2-sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the concentrations (20vPnC - 13vPnC) and the corresponding CIs (based on the Student's t distribution).|Rubella||1.10|0.63|
72507021|NCT03408873|144546106|OTHER||Mean Difference (Final Values)|-11.7||||0.12|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||We compared the repeated measure outcome across 2 time-points (difference between baseline \& week 24 to determine whether the population medians differed matched on participant with complete data. Of the 28 participants with baseline data only 11 had Week 24 data. Statistical Analysis was conducted for 11 participants with data at the 2 timepoints. The mean difference reported is not consistent with the mean values reported because only those with complete data were included in the analysis.||||0.12
72623071|NCT04003389|144776428|SUPERIORITY||LSMean difference|0.001|STANDARD_ERROR_OF_MEAN|0.027||0.98|TWO_SIDED|95.0|-0.052|0.053||The LSM, SE, CI, and p-values come from an ANCOVA model with change from baseline at the Week 52 timepoint as response, treatment and smoking status (current vs former/never) as fixed effects with baseline weight and baseline as covariates.|ANCOVA|||Hip (Femoral Neck)||0.053|-0.052|0.980
72398177|NCT02636868|144302396|SUPERIORITY|||||||0.312||||||A priori threshold of statistical significance set at 0.10|Regression, Linear|Generalized linear model using Poisson distribution with pooled site, treatment, gender, birth weight, and baseline FiO₂ in model||Null hypothesis of no difference between treatment groups||||0.312
72398178|NCT02636868|144302396|SUPERIORITY|||||||0.094||||||A priori threshold of statistical significance set at 0.10|Regression, Linear|Generalized linear model using Poisson distribution with pooled site, treatment, gender, birth weight, and baseline FiO₂ in model||Null hypothesis of no difference between treatment groups||||0.094
72398179|NCT02636868|144302396|SUPERIORITY|||||||0.414||||||A priori threshold of statistical significance set at 0.10|Regression, Linear|Generalized linear model using Poisson distribution with pooled site, treatment, gender, birth weight, and baseline FiO₂ in model.||Null hypothesis of no difference between treatment groups||||0.414
72398180|NCT02636868|144302397|SUPERIORITY|||||||0.099||||||A priori statistical significance of 0.05|Regression, Logistic|Pooled site, treatment, gender, birth weight, and baseline fraction of inspired oxygen (FiO2) in model||Null hypothesis of no difference between treatment groups||||0.099
72398181|NCT02636868|144302397|SUPERIORITY|||||||0.09||||||A priori statistical significance of 0.05|Regression, Logistic|Pooled site, treatment, gender, birth weight, and baseline FiO2 in model||Null hypothesis of no difference between treatments||||0.090
72565836|NCT02709486|144662707|SUPERIORITY||Least Square Mean Difference|-6.0|STANDARD_ERROR_OF_MEAN|1.79||0.0008|TWO_SIDED|95.0|-9.51|-2.5|||ANCOVA|||Week 16: Percent Activity Impairment: WPAI parameters were analyzed using ANCOVA model which included covariates of the corresponding baseline score, baseline diary average pain, index joint, highest Kellgren-Lawrence grade (2, 3 or 4), and treatment, with study site as a random effect.||-2.50|-9.51|0.0008
72565837|NCT02709486|144662707|SUPERIORITY||Least Square Mean Difference|-6.97|STANDARD_ERROR_OF_MEAN|1.77|<|0.0001|TWO_SIDED|95.0|-10.44|-3.51|||ANCOVA|||Week 16: Percent Activity Impairment: WPAI parameters were analyzed using ANCOVA model which included covariates of the corresponding baseline score, baseline diary average pain, index joint, highest Kellgren-Lawrence grade (2, 3 or 4), and treatment, with study site as a random effect.||-3.51|-10.44|<.0001
72565838|NCT02709486|144662707|SUPERIORITY||Least Square Mean Difference|-3.08|STANDARD_ERROR_OF_MEAN|1.87||0.1004|TWO_SIDED|95.0|-6.76|0.6|||ANCOVA|||Week 24: Percent Activity Impairment: WPAI parameters were analyzed using ANCOVA model which included covariates of the corresponding baseline score, baseline diary average pain, index joint, highest Kellgren-Lawrence grade (2, 3 or 4), and treatment, with study site as a random effect.||0.60|-6.76|0.1004
72565839|NCT02709486|144662707|SUPERIORITY||Least Square Mean Difference|-4.94|STANDARD_ERROR_OF_MEAN|1.86||0.0079|TWO_SIDED|95.0|-8.59|-1.3|||ANCOVA|||Week 24: Percent Activity Impairment: WPAI parameters were analyzed using ANCOVA model which included covariates of the corresponding baseline score, baseline diary average pain, index joint, highest Kellgren-Lawrence grade (2, 3 or 4), and treatment, with study site as a random effect||-1.30|-8.59|0.0079
72565840|NCT02709486|144662722|SUPERIORITY||Odds Ratio (OR)|0.1||||0.0027|TWO_SIDED|95.0|0.02|0.46|||Regression, Logistic|||Logistic regression model included baseline diary average pain, baseline WOMAC pain score, classification variables index joint, highest Kellgren-Lawrence grade and treatment. Odds ratio and 95% CI estimated from logistic regression model.||0.46|0.02|0.0027
72565841|NCT02709486|144662722|SUPERIORITY||Odds Ratio (OR)|0.16||||0.0033|TWO_SIDED|95.0|0.05|0.54|||Regression, Logistic|||Logistic regression model included baseline diary average pain, baseline WOMAC pain score, classification variables index joint, highest Kellgren-Lawrence grade and treatment. Odds ratio and 95% CI estimated from logistic regression model.||0.54|0.05|0.0033
72565842|NCT02709486|144662723|SUPERIORITY|||||||0.0002||||||P-value based on the log-rank test.|Log Rank|||Missing data for the selected percentile(s) was due to the Kaplan-Meier estimate not reaching the level for discontinuation due to lack of efficacy.||||0.0002
72398182|NCT02636868|144302397|SUPERIORITY|||||||0.461||||||A priori statistical significance of 0.05|Regression, Logistic|Pooled site, treatment, gender, birth weight, and baseline FiO2 in model||Null hypothesis of no difference between treatment groups||||0.461
72473331|NCT04546425|144470475|NON_INFERIORITY|Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|1.24|||||TWO_SIDED|95.0|0.98|1.57|||||GMR and 2-sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the concentrations (20vPnC - 13vPnC) and the corresponding CIs (based on the Student's t distribution).|Varicella||1.57|0.98|
72565843|NCT02709486|144662723|SUPERIORITY|||||||0.0007||||||P-value based on the log-rank test.|Log Rank|||Missing data for the selected percentile(s) was due to the Kaplan-Meier estimate not reaching the level for discontinuation due to lack of efficacy.||||0.0007
72565844|NCT02709486|144662724|SUPERIORITY||Odds Ratio (OR)|0.42|||<|0.0001|TWO_SIDED|95.0|0.29|0.59|||Regression, Logistic|||Week 2: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||0.59|0.29|<.0001
72565845|NCT02709486|144662724|SUPERIORITY||Odds Ratio (OR)|0.55||||0.001|TWO_SIDED|95.0|0.38|0.78|||Regression, Logistic|||Week 2: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||0.78|0.38|0.0010
72565846|NCT02709486|144662724|SUPERIORITY||Odds Ratio (OR)|0.5|||<|0.0001|TWO_SIDED|95.0|0.36|0.7|||Regression, Logistic|||Week 4: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||0.70|0.36|<.0001
72565847|NCT02709486|144662724|SUPERIORITY||Odds Ratio (OR)|0.62||||0.0067|TWO_SIDED|95.0|0.44|0.88|||Regression, Logistic|||Week 4: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||0.88|0.44|0.0067
72565848|NCT02709486|144662724|SUPERIORITY||Odds Ratio (OR)|0.64||||0.0087|TWO_SIDED|95.0|0.45|0.89|||Regression, Logistic|||Week 8: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||0.89|0.45|0.0087
72565849|NCT02709486|144662724|SUPERIORITY||Odds Ratio (OR)|0.74||||0.0787|TWO_SIDED|95.0|0.53|1.04|||Regression, Logistic|||Week 8: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||1.04|0.53|0.0787
72565850|NCT02709486|144662724|SUPERIORITY||Odds Ratio (OR)|0.65||||0.0129|TWO_SIDED|95.0|0.47|0.91|||Regression, Logistic|||Week 12: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||0.91|0.47|0.0129
72565851|NCT02709486|144662724|SUPERIORITY||Odds Ratio (OR)|0.65||||0.0124|TWO_SIDED|95.0|0.47|0.91|||Regression, Logistic|||Week 12: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||0.91|0.47|0.0124
72565852|NCT02709486|144662724|SUPERIORITY||Odds Ratio (OR)|0.7||||0.0399|TWO_SIDED|95.0|0.5|0.98|||Regression, Logistic|||Week 16: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||0.98|0.50|0.0399
72398183|NCT02636868|144302398|SUPERIORITY|||||||0.534||||||A priori threshold for statistical significance set at 0.05|ANOVA|treatment and pooled site in model||Null hypothesis of no treatment between treatments||||0.534
72398184|NCT02636868|144302398|SUPERIORITY|||||||0.48||||||A priori threshold for statistical significance set at 0.05|ANOVA|Treatment and pooled site in model||Null hypothesis of no difference between treatment groups||||0.480
72398185|NCT02636868|144302398|SUPERIORITY|||||||0.313||||||A priori threshold for statistical significance set at 0.05|ANOVA|Treatment and pooled site in model||Null hypothesis of no difference between treatment groups||||0.313
72398186|NCT02127567|144302478|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.1|||<|0.001|TWO_SIDED|95.0|1.5|2.7|||Mixed Models Analysis|||||2.7|1.5|<0.001
72398187|NCT02127567|144302479|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.8|||<|0.01|TWO_SIDED|95.0|1.1|4.4|||Mixed Models Analysis|||||4.4|1.1|<0.01
72398188|NCT02127567|144302480|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.7||||0.44|TWO_SIDED|95.0|-0.7|2.0|||Mixed Models Analysis|||||2.0|-0.7|0.44
72473332|NCT04546425|144470489|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC is to the corresponding serotype in 13vPnC group.|Percent difference|-1.0|||||TWO_SIDED|95.0|-3.1|0.9|||||2-Sided 95% CIs are calculated using the Miettinen and Nurminen method for the difference in proportions, expressed as a percentage.|Serotype 1 \\||0.9|-3.1|
72473333|NCT04546425|144470489|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC is to the corresponding serotype in 13vPnC group.|Percent difference|-10.6|||||TWO_SIDED|95.0|-14.7|-6.7|||||2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.|Serotype 3||-6.7|-14.7|
72473334|NCT04546425|144470489|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC is to the corresponding serotype in 13vPnC group.|Percent difference|0.0|||||TWO_SIDED|95.0|-1.4|1.3|||||2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.|Serotype 4||1.3|-1.4|
72473335|NCT04546425|144470489|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC is to the corresponding serotype in 13vPnC group.|Percent difference|0.4|||||TWO_SIDED|95.0|-1.4|2.2|||||2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.|Serotype 5||2.2|-1.4|
72473336|NCT04546425|144470489|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC is to the corresponding serotype in 13vPnC group.|Percent difference|0.0|||||TWO_SIDED|95.0|-1.6|1.5|||||2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.|Serotype 6A||1.5|-1.6|
72473337|NCT04546425|144470489|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC is to the corresponding serotype in 13vPnC group.|Percent difference|0.8|||||TWO_SIDED|95.0|-1.1|2.7|||||2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.|Serotype 6B||2.7|-1.1|
72398189|NCT02127567|144302481|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.2|||<|0.01|TWO_SIDED|95.0|0.8|3.6|||Mixed Models Analysis|||||3.6|0.8|<0.01
72398190|NCT02127567|144302482|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|1.8|||<|0.01|TWO_SIDED|95.0|0.7|2.9|||Mixed Models Analysis|||||2.9|0.7|<0.01
72398191|NCT02127567|144302483|SUPERIORITY||Mean Difference (Final Values)|-0.3||||0.78|TWO_SIDED|95.0|-2.0|1.3|||Mixed Models Analysis|||||1.3|-2.0|0.78
72398192|NCT02127567|144302484|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.4|||<|0.01|TWO_SIDED|95.0|4.1|6.7|||Mixed Models Analysis|||||6.7|4.1|<0.01
72398193|NCT02127567|144302485|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.4||||0.002|TWO_SIDED|95.0|0.5|2.3|||Mixed Models Analysis|||||2.3|0.5|0.002
72398194|NCT01969240|144302527|SUPERIORITY||Mean Difference (Final Values)|0.66|||||TWO_SIDED|95.0|0.46|0.86||||||||0.86|0.46|
72398195|NCT01969240|144302528|SUPERIORITY||||||<|0.013|||||||t-test, 2 sided|The a-priori significance level was 0.05.||||||<0.013
72398196|NCT01969240|144302529|SUPERIORITY||Mean Difference (Final Values)|10.3|||||TWO_SIDED|95.0|9.1|11.5||||||||11.5|9.1|
72398197|NCT01969240|144302530|SUPERIORITY|||||||0.998|||||||Regression, Logistic|||||||0.998
72398198|NCT01969240|144302531|SUPERIORITY||||||<|0.001|||||||negative binomial model|||||||<0.001
72398199|NCT01969240|144302532|SUPERIORITY||Mean Difference (Final Values)|-2.9|||||TWO_SIDED|95.0|-4.8|-0.9||||||||-0.90|-4.8|
72398200|NCT01969240|144302533|SUPERIORITY||Median Difference (Final Values)|1.7|||||TWO_SIDED|95.0|-0.2|3.6||||||||3.6|-0.2|
72398201|NCT03518073|144302538|SUPERIORITY||Posterior Mean Ratio|1.1|||||TWO_SIDED|95.0|0.959|1.265|||||Posterior mean ratio with 95% credible interval is reported.|||1.265|0.959|
72398202|NCT03518073|144302538|SUPERIORITY||Posterior Mean Ratio|1.05|||||TWO_SIDED|95.0|0.907|1.209|||||Posterior mean ratio with 95% credible interval is reported.|||1.209|0.907|
72398203|NCT03518073|144302539|SUPERIORITY||Posterior Mean Ratio|1.11|||||TWO_SIDED|95.0|0.943|1.29|||||Posterior mean ratio with 95% credible interval is reported.|||1.290|0.943|
72398204|NCT03518073|144302539|SUPERIORITY||Posterior Mean Ratio|0.89|||||TWO_SIDED|95.0|0.737|1.053|||||Posterior mean ratio with 95% credible interval is reported.|||1.053|0.737|
72398205|NCT03518073|144302540|SUPERIORITY||Posterior Mean Ratio|1.06|||||TWO_SIDED|95.0|0.873|1.284|||||Posterior mean ratio with 95% credible interval is reported.|||1.284|0.873|
72398206|NCT03518073|144302540|SUPERIORITY||Posterior Mean Ratio|1.21|||||TWO_SIDED|95.0|1.006|1.453|||||Posterior mean ratio with 95% credible interval is reported.|||1.453|1.006|
72398207|NCT03518073|144302541|SUPERIORITY||Posterior Mean Ratio|1.12|||||TWO_SIDED|95.0|0.963|1.3|||||Posterior mean ratio with 95% credible interval is reported.|||1.300|0.963|
72398208|NCT03518073|144302541|SUPERIORITY||Posterior Mean Ratio|0.95|||||TWO_SIDED|95.0|0.805|1.119|||||Posterior mean ratio with 95% credible interval is reported.|||1.119|0.805|
72398209|NCT03518073|144302542|SUPERIORITY||Posterior Mean Ratio|1.04|||||TWO_SIDED|95.0|0.88|1.221|||||Posterior mean ratio with 95% credible interval is reported.|||1.221|0.880|
72398210|NCT03518073|144302542|SUPERIORITY||Posterior Mean Ratio|0.89|||||TWO_SIDED|95.0|0.742|1.065|||||Posterior mean ratio with 95% credible interval is reported.|||1.065|0.742|
72398211|NCT03518073|144302543|SUPERIORITY||LS Mean Difference|0.02|STANDARD_ERROR_OF_MEAN|0.016||0.253|TWO_SIDED|95.0|-0.01|0.05|||Mixed Models Analysis|||||0.05|-0.01|0.253
72398212|NCT03518073|144302543|SUPERIORITY||LS Mean Difference|0.02|STANDARD_ERROR_OF_MEAN|0.016||0.354|TWO_SIDED|95.0|-0.02|0.05|||Mixed Models Analysis|||||0.05|-0.02|0.354
72398213|NCT03518073|144302544|SUPERIORITY||LS Mean Difference|0.62|STANDARD_ERROR_OF_MEAN|1.554||0.691|TWO_SIDED|95.0|-2.44|3.68|||Mixed Models Analysis|||||3.68|-2.44|0.691
72507022|NCT03408873|144546107|OTHER||Mean Difference (Final Values)|-19.6||||0.0599|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||We compared the repeated measure outcome across 2 time-points (difference between screen \& week 24 to determine whether the population medians differed matched on participant with complete data. Of the 29 participants with screen data only 11 had Week 24 data. Statistical Analysis was conducted for 11 participants with data at the 2 timepoints. Thus, the mean difference reported is not consistent with the mean values reported because only those with complete data were included in the analysis.||||0.0599
72473338|NCT04546425|144470489|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC is to the corresponding serotype in 13vPnC group.|Percent difference|-0.4|||||TWO_SIDED|95.0|-1.5|0.4|||||2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.|Serotype 7F||0.4|-1.5|
72473339|NCT04546425|144470489|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC is to the corresponding serotype in 13vPnC group.|Percent difference|0.4|||||TWO_SIDED|95.0|-1.0|1.9|||||2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.|Serotype 9V||1.9|-1.0|
72473340|NCT04546425|144470489|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC is to the corresponding serotype in 13vPnC group.|Percent difference|-1.5|||||TWO_SIDED|95.0|-3.7|0.6|||||2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.|Serotype 14||0.6|-3.7|
72473341|NCT04546425|144470489|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC is to the corresponding serotype in 13vPnC group.|Percent difference|1.0|||||TWO_SIDED|95.0|-0.5|2.7|||||2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.|Serotype 18C||2.7|-0.5|
72473342|NCT04546425|144470489|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC is to the corresponding serotype in 13vPnC group.|Percent difference|0.0|||||TWO_SIDED|95.0|-1.1|1.1|||||2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.|Serotype 19A||1.1|-1.1|
72473343|NCT04546425|144470489|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC is to the corresponding serotype in 13vPnC group.|Percent difference|0.2|||||TWO_SIDED|95.0|-0.9|1.4|||||2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.|Serotype 19F||1.4|-0.9|
72473344|NCT04546425|144470489|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC is to the corresponding serotype in 13vPnC group.|Percent difference|-0.9|||||TWO_SIDED|95.0|-3.2|1.4|||||2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.|Serotype 23F||1.4|-3.2|
72473345|NCT04546425|144470489|NON_INFERIORITY|For the additional 7 serotypes, the compared results are from serotype 23F(13vPnC serotype with the lowest percentage, not including serotype 3) in the 13vPnC group.|Percent difference|2.0|||||TWO_SIDED|95.0|0.4|3.9|||||2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.|Serotype 8||3.9|0.4|
72473346|NCT04546425|144470489|NON_INFERIORITY|For the additional 7 serotypes, the compared results are from serotype 23F(13vPnC serotype with the lowest percentage, not including serotype 3) in the 13vPnC group.|Percent difference|0.6|||||TWO_SIDED|95.0|-1.5|2.7|||||2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.|Serotype 10A||2.7|-1.5|
72473347|NCT04546425|144470489|NON_INFERIORITY|For the additional 7 serotypes, the compared results are from serotype 23F (13vPnC serotype with the lowest percentage, not including serotype 3) in the 13vPnC group.|Percent difference|1.2|||||TWO_SIDED|95.0|-0.7|3.2|||||2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.|Serotype 11A||3.2|-0.7|
72473348|NCT04546425|144470489|NON_INFERIORITY|For the additional 7 serotypes, the compared results are from serotype 23F (13vPnC serotype with the lowest percentage, not including serotype 3) in the 13vPnC group.|Percent difference|-0.6|||||TWO_SIDED|95.0|-2.9|1.6|||||2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.|Serotype 12F||1.6|-2.9|
72473349|NCT04546425|144470489|NON_INFERIORITY|For the additional 7 serotypes, the compared results are from serotype 23F (13vPnC serotype with the lowest percentage, not including serotype 3) in the 13vPnC group.|Percent difference|2.2|||||TWO_SIDED|95.0|0.7|4.1|||||2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.|Serotype 15B||4.1|0.7|
72473350|NCT04546425|144470489|NON_INFERIORITY|For the additional 7 serotypes, the compared results are from serotype 23F(13vPnC serotype with the lowest percentage, not including serotype 3) in the 13vPnC group.|Percent difference|2.0|||||TWO_SIDED|95.0|0.4|3.9|||||2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.|Serotype 22F||3.9|0.4|
72398214|NCT03518073|144302544|SUPERIORITY||LS Mean Difference|0.51|STANDARD_ERROR_OF_MEAN|1.599||0.749|TWO_SIDED|95.0|-2.64|3.66|||Mixed Models Analysis|||||3.66|-2.64|0.749
72473351|NCT04546425|144470489|NON_INFERIORITY|For the additional 7 serotypes, the compared results are from serotype 23F (13vPnC serotype with the lowest percentage, not including serotype 3) in the 13vPnC group.|Percent difference|1.4|||||TWO_SIDED|95.0|-0.4|3.4|||||2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.|Serotype 33F||3.4|-0.4|
72473352|NCT04546425|144470493|NON_INFERIORITY|Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/13vPnC) was greater than 0.5 (2-fold criterion).|Percent difference|-4.5|||||TWO_SIDED|95.0|-11.2|2.1|||||2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions (20vPnC - 13vPnC) expressed as a percentage.|Diphtheria||2.1|-11.2|
72473353|NCT04546425|144470493|NON_INFERIORITY|Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/13vPnC) was greater than 0.5 (2-fold criterion).|Percent difference|-3.0|||||TWO_SIDED|95.0|-7.0|0.4|||||2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions (20vPnC - 13vPnC) expressed as a percentage.|Tetanus||0.4|-7.0|
72565853|NCT02709486|144662724|SUPERIORITY||Odds Ratio (OR)|0.62||||0.006|TWO_SIDED|95.0|0.45|0.87|||Regression, Logistic|||Week 16: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||0.87|0.45|0.0060
72473354|NCT04546425|144470493|NON_INFERIORITY|Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/13vPnC) was greater than 0.5 (2-fold criterion).|Percent difference|-0.5|||||TWO_SIDED|95.0|-5.2|4.1|||||2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions (20vPnC - 13vPnC) expressed as a percentage.|PT||4.1|-5.2|
72473355|NCT04546425|144470493|NON_INFERIORITY|Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/13vPnC) was greater than 0.5 (2-fold criterion).|Percent difference|-1.5|||||TWO_SIDED|95.0|-6.4|3.3|||||2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions (20vPnC - 13vPnC) expressed as a percentage.|FHA||3.3|-6.4|
72473356|NCT04546425|144470493|NON_INFERIORITY|Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/13vPnC) was greater than 0.5 (2-fold criterion).|Percent difference|-1.5|||||TWO_SIDED|95.0|-6.4|3.3|||||2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions (20vPnC - 13vPnC) expressed as a percentage.|PRN||3.3|-6.4|
72473357|NCT04546425|144470493|NON_INFERIORITY|Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/13vPnC) was greater than 0.5 (2-fold criterion).|Percent difference|-3.3|||||TWO_SIDED|95.0|-10.0|2.2|||||2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions (20vPnC - 13vPnC) expressed as a percentage.|Poliovirus Type 1||2.2|-10.0|
72473358|NCT04546425|144470493|NON_INFERIORITY|Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/13vPnC) was greater than 0.5 (2-fold criterion).|Percent difference|-2.8|||||TWO_SIDED|95.0|-11.8|5.8|||||2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions (20vPnC - 13vPnC) expressed as a percentage.|Poliovirus Type 2||5.8|-11.8|
72473359|NCT04546425|144470493|NON_INFERIORITY|Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/13vPnC) was greater than 0.5 (2-fold criterion).|Percent difference|-4.2|||||TWO_SIDED|95.0|-10.2|-0.5|||||2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions (20vPnC - 13vPnC) expressed as a percentage.|Poliovirus Type 3||-0.5|-10.2|
72473360|NCT04546425|144470493|NON_INFERIORITY|Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/13vPnC) was greater than 0.5 (2-fold criterion).|Percent difference|0.0|||||TWO_SIDED|95.0|-1.8|2.0|||||2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions (20vPnC - 13vPnC) expressed as a percentage.|Hib||2.0|-1.8|
72473361|NCT01399697|144470546|SUPERIORITY_OR_OTHER|||||||0.7|TWO_SIDED||||||ANCOVA|||||||0.700
72473362|NCT01399697|144470547|SUPERIORITY_OR_OTHER|||||||0.328|TWO_SIDED||||||Chi-squared|||||||0.328
72473363|NCT01399697|144470548|SUPERIORITY_OR_OTHER|||||||0.518|TWO_SIDED||||||Chi-squared|||||||0.518
72473364|NCT01399697|144470549|SUPERIORITY_OR_OTHER|||||||0.358|TWO_SIDED||||||Chi-squared|||||||0.358
72473365|NCT01399697|144470550|SUPERIORITY_OR_OTHER||Difference in Least Square (LS) Mean|0.032||||0.674|TWO_SIDED|95.0|-0.119|0.184|||ANCOVA||Analysis of covariance (ANCOVA) model with treatment as factor and DAS28 value at Week 16 as covariate.|||0.184|-0.119|0.674
72473366|NCT01399697|144470551|SUPERIORITY_OR_OTHER||Difference in LS Mean|-1.873||||0.204|TWO_SIDED|95.0|-4.775|1.03|||ANCOVA||ANCOVA model with treatment as factor and mental component score (MCS) as covariate.|||1.030|-4.775|0.204
72473367|NCT01399697|144470552|SUPERIORITY_OR_OTHER||Difference in LS Mean|3.376||||0.015|TWO_SIDED|95.0|0.676|6.076|||ANCOVA||ANCOVA model with treatment as factor and physical component score (PCS) as covariate.|||6.076|0.676|0.015
72398215|NCT01853046|144302547|SUPERIORITY_OR_OTHER||LS Mean|1.14|||||TWO_SIDED|90.0|0.796|1.63||||||Point estimates (LS-means) and 2-sided exploratory 90% confidence intervals for AUC(0-tlast) of regorafenib calculated by re-transformation of the logarithmic data from ANOVAs.||1.63|0.796|
72473368|NCT01399697|144470553|SUPERIORITY_OR_OTHER||Difference in LS Mean|0.969||||0.769|TWO_SIDED|95.0|-5.526|7.464|||ANCOVA||ANCOVA model with treatment as factor and VAS performed by the participant at Week 16 as a covariate.|||7.464|-5.526|0.769
72473369|NCT01399697|144470554|SUPERIORITY_OR_OTHER||Difference in LS Mean|-1.216||||0.655|TWO_SIDED|95.0|-6.573|4.141|||ANCOVA||ANCOVA model with treatment as factor and VAS performed by the investigator at Week 16 as covariate.|||4.141|-6.573|0.655
72473370|NCT01038427|144470593|EQUIVALENCE|If the 90% confidence intervals were contained within the interval 80.0% to 125.0%, then the two products were considered to be therapeutically equivalent.|Ratio Test/Ref. Least Squares (LS) Means|106.644|||||TWO_SIDED|90.0|91.86|123.997||||||||123.997|91.860|
72473371|NCT01038427|144470594|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
72473372|NCT01038427|144470594|SUPERIORITY|||||||0.0001|||||||ANCOVA|||||||0.0001
72473373|NCT01038427|144470595|EQUIVALENCE|90% confidence intervals within the interval 80.0% to 125.0%.|Ratio Test/Ref. LS Means|109.716|||||TWO_SIDED|90.0|93.316|129.159||||||||129.159|93.316|
72473374|NCT01038427|144470596|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
72473375|NCT01038427|144470596|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
72473376|NCT01038427|144470597|SUPERIORITY|||||||0.2655|||||||Cochran-Mantel-Haenszel|||||||0.2655
72473377|NCT01038427|144470597|SUPERIORITY|||||||0.0009|||||||Cochran-Mantel-Haenszel|||||||0.0009
72473378|NCT01038427|144470597|SUPERIORITY|||||||0.1093|||||||Cochran-Mantel-Haenszel|||||||0.1093
72473379|NCT01038427|144470598|SUPERIORITY|||||||0.9915|||||||Cochran-Mantel-Haenszel|||||||0.9915
72473380|NCT01038427|144470598|SUPERIORITY|||||||0.0312|||||||Cochran-Mantel-Haenszel|||||||0.0312
72473381|NCT01038427|144470598|SUPERIORITY|||||||0.0487|||||||Cochran-Mantel-Haenszel|||||||0.0487
72473382|NCT01327846|144470609|SUPERIORITY|A HR \< 1 favors Canakinumab|Cox Proportional Hazard|0.86||||0.0648|TWO_SIDED|95.0|0.75|0.99||1-sided adjusted for multiplicity using weighted Dunnett test. \[significance level 0.0245\]|Log Rank||MACE|H11: The hazard rate of first adjudication committee confirmed MACE in the canakinumab 300 mg dose group is greater than or equal to the hazard rate of the placebo group||0.99|0.75|0.0648
72473383|NCT01327846|144470609|SUPERIORITY|A HR \< 1 favors Canakinumab|Cox Proportional Hazard|0.85||||0.0241|TWO_SIDED|95.0|0.74|0.98||1-sided adjusted for multiplicity using weighted Dunnett test. \[significance level 0.0245\]|Log Rank||MACE|H21: The hazard rate of first adjudication committee confirmed MACE in the canakinumab 150 mg dose group is greater than or equal to the hazard rate of the placebo group||0.98|0.74|0.0241
72473384|NCT01327846|144470609|SUPERIORITY|A HR \< 1 favors Canakinumab|Cox Proportional Hazard|0.93||||0.1895|TWO_SIDED|95.0|0.8|1.07||1-sided adjusted for multiplicity using weighted Dunnett test. \[significance level 0.0245\]|Log Rank||MACE|H31: The hazard rate of first adjudication committee confirmed MACE in the canakinumab 50 mg dose group is greater than or equal to the hazard rate of the placebo group.||1.07|0.80|0.1895
72473385|NCT01327846|144470609|SUPERIORITY|A HR \< 1 favors Canakinumab|Hazard Ratio (HR)|0.94||||0.572|TWO_SIDED|95.0|0.77|1.16||2-sided unadjusted p-value|Regression, Cox||CV death|||1.16|0.77|0.572
72473386|NCT01327846|144470609|SUPERIORITY|A HR \< 1 favors Canakinumab|Hazard Ratio (HR)|0.9||||0.296|TWO_SIDED|95.0|0.73|1.1||2-sided unadjusted p-value|Regression, Cox||CV death|||1.10|0.73|0.296
72473387|NCT01327846|144470609|SUPERIORITY|A HR \< 1 favors Canakinumab|Hazard Ratio (HR)|0.91||||0.369|TWO_SIDED|95.0|0.73|1.12||2-sided unadjusted p-value|Regression, Cox||CV death|||1.12|0.73|0.369
72473388|NCT01327846|144470609|SUPERIORITY|A HR \< 1 favors Canakinumab|Hazard Ratio (HR)|0.84||||0.067|TWO_SIDED|95.0|0.69|1.01||2-sided unadjusted p-value|Regression, Cox||MI (fatal and non-fatal)|||1.01|0.69|0.067
72473389|NCT01327846|144470609|SUPERIORITY|A HR \< 1 favors Canakinumab|Hazard Ratio (HR)|0.76||||0.006|TWO_SIDED|95.0|0.63|0.92||2-sided unadjusted p-value|Regression, Cox||MI (fatal and non-fatal)|||0.92|0.63|0.006
72473390|NCT01327846|144470609|SUPERIORITY|A HR \< 1 favors Canakinumab|Hazard Ratio (HR)|0.94||||0.542|TWO_SIDED|95.0|0.78|1.14||2-sided unadjusted p-value|Regression, Cox||MI (fatal and non-fatal)|||1.14|0.78|0.542
72473391|NCT01327846|144470609|OTHER|A HR \< 1 favors Canakinumab|Hazard Ratio (HR)|0.83|||||TWO_SIDED|95.0|0.68|1.0|||||MI (non-fatal)|||1.00|0.68|
72473392|NCT01327846|144470609|OTHER|A HR \< 1 favors Canakinumab|Hazard Ratio (HR)|0.76|||||TWO_SIDED|95.0|0.62|0.92|||||MI (non-fatal)|||0.92|0.62|
72623072|NCT04003389|144776428|SUPERIORITY||LSMean difference|0.048|STANDARD_ERROR_OF_MEAN|0.023||0.042||95.0|0.002|0.094||The LSM, SE, CI, and p-values come from an ANCOVA model with change from baseline at the Week 52 timepoint as response, treatment and smoking status (current vs former/never) as fixed effects with baseline weight and baseline as covariates.|ANCOVA|||Hip (Femur)||0.094|0.002|0.042
72473393|NCT01327846|144470609|OTHER|A HR \< 1 favors Canakinumab|Hazard Ratio (HR)|0.94|||||TWO_SIDED|95.0|0.78|1.14|||||MI (non-fatal)|||1.14|0.78|
72473394|NCT01327846|144470609|SUPERIORITY|A HR \< 1 favors Canakinumab|Hazard Ratio (HR)|0.8||||0.19|TWO_SIDED|95.0|0.56|1.12||2-sided unadjusted p-value|Regression, Cox||Stroke (fatal and non-fatal)|||1.12|0.56|0.190
72473395|NCT01327846|144470609|SUPERIORITY|A HR \< 1 favors Canakinumab|Hazard Ratio (HR)|0.98||||0.912|TWO_SIDED|95.0|0.71|1.35||2-sided unadjusted p-value|Regression, Cox||Stroke (fatal and non-fatal)|||1.35|0.71|0.912
72473396|NCT01327846|144470609|SUPERIORITY|A HR \< 1 favors Canakinumab|Hazard Ratio (HR)|1.03||||0.871|TWO_SIDED|95.0|0.74|1.43||2-sided unadjusted p-value|Regression, Cox||Stroke (fatal and non-fatal)|||1.43|0.74|0.871
72473397|NCT01327846|144470609|OTHER|A HR \< 1 favors Canakinumab|Hazard Ratio (HR)|0.8|||||TWO_SIDED|95.0|0.57|1.13|||||Stroke (nonfatal)|||1.13|0.57|
72473398|NCT01327846|144470609|OTHER|A HR \< 1 favors Canakinumab|Hazard Ratio (HR)|0.99|||||TWO_SIDED|95.0|0.72|1.37|||||Stroke (nonfatal)|||1.37|0.72|
72473399|NCT01327846|144470609|OTHER|A HR \< 1 favors Canakinumab|Hazard Ratio (HR)|1.04|||||TWO_SIDED|95.0|0.75|1.45|||||Stroke (nonfatal)|||1.45|0.75|
72473400|NCT01327846|144470612|SUPERIORITY|A HR \< 1 favors Canakinumab|Hazard Ratio (HR)|0.82||||0.0648|TWO_SIDED|95.0|0.72|0.94||1-sided adjusted for multiplicity using weighted Dunnett test. \[significance level 0.0245\]|Log Rank||MACE or unstable angina|||0.94|0.72|0.0648
72473401|NCT01327846|144470612|SUPERIORITY|A HR \< 1 favors Canakinumab|Hazard Ratio (HR)|0.83||||0.0241|TWO_SIDED|95.0|0.73|0.95||1-sided adjusted for multiplicity using weighted Dunnett test. \[significance level 0.0245\]|Log Rank||MACE or unstable angina|||0.95|0.73|0.0241
72473402|NCT01327846|144470612|SUPERIORITY|A HR \< 1 favors Canakinumab|Hazard Ratio (HR)|0.9||||0.1895|TWO_SIDED|95.0|0.79|1.03||1-sided adjusted for multiplicity using weighted Dunnett test. \[significance level 0.0245\]|Log Rank||MACE or unstable angina|||1.03|0.79|0.1895
72473403|NCT01327846|144470612|SUPERIORITY|A HR \< 1 favors Canakinumab|Hazard Ratio (HR)|0.58||||0.007|TWO_SIDED|95.0|0.39|0.86||2-sided unadjusted p-value|Regression, Cox||unstable angina|||0.86|0.39|0.007
72473404|NCT01327846|144470612|SUPERIORITY|A HR \< 1 favors Canakinumab|Hazard Ratio (HR)|0.64||||0.022|TWO_SIDED|95.0|0.44|0.94||2-sided unadjusted p-value|Regression, Cox||unstable angina|||0.94|0.44|0.022
72473405|NCT01327846|144470612|SUPERIORITY|A HR \< 1 favors Canakinumab|Hazard Ratio (HR)|0.71||||0.086|TWO_SIDED|95.0|0.48|1.05||2-sided unadjusted p-value|Regression, Cox||unstable angina|||1.05|0.48|0.086
72473406|NCT01327846|144470613|SUPERIORITY|A HR \< 1 favors Canakinumab|Hazard Ratio (HR)|1.01||||0.8456|TWO_SIDED|95.0|0.83|1.23||1-sided adjusted for multiplicity using weighted Dunnett test. \[significance level 0.0245\]|Log Rank|||||1.23|0.83|0.8456
72473407|NCT01327846|144470613|SUPERIORITY|A HR \< 1 favors Canakinumab|Hazard Ratio (HR)|1.06||||0.8456|TWO_SIDED|95.0|0.87|1.29||1-sided adjusted for multiplicity using weighted Dunnett test. \[significance level 0.0245\]|Log Rank|||||1.29|0.87|0.8456
72473408|NCT01327846|144470613|SUPERIORITY|A HR \< 1 favors Canakinumab|Hazard Ratio (HR)|0.98||||0.6541|TWO_SIDED|95.0|0.8|1.2||1-sided adjusted for multiplicity using weighted Dunnett test. \[significance level 0.0245\]|Log Rank|||||1.20|0.80|0.6541
72473409|NCT01327846|144470614|SUPERIORITY||Hazard Ratio (HR)|0.87||||0.028|TWO_SIDED|95.0|0.77|0.99||2-sided unadjusted p-value|Regression, Cox||All-cause mortality or MI or Stroke|||0.99|0.77|0.028
72473410|NCT01327846|144470614|SUPERIORITY||Hazard Ratio (HR)|0.85||||0.011|TWO_SIDED|95.0|0.75|0.96||2-sided unadjusted p-value|Regression, Cox||All-cause mortality or MI or Stroke|||0.96|0.75|0.011
72473411|NCT01327846|144470614|SUPERIORITY||Hazard Ratio (HR)|0.94||||0.377|TWO_SIDED|95.0|0.83|1.07||2-sided unadjusted p-value|Regression, Cox||All-cause mortality or MI or Stroke|||1.07|0.83|0.377
72473412|NCT01327846|144470615|SUPERIORITY|A HR \< 1 favors Canakinumab|Hazard Ratio (HR)|0.93||||0.406|TWO_SIDED|95.0|0.79|1.1||2-sided unadjusted p-value|Regression, Cox||All-cause mortality|||1.10|0.79|0.406
72473413|NCT01327846|144470615|SUPERIORITY|A HR \< 1 favors Canakinumab|Hazard Ratio (HR)|0.92||||0.329|TWO_SIDED|95.0|0.78|1.09||2-sided unadjusted p-value|Regression, Cox||All-cause mortality|||1.09|0.78|0.329
72623073|NCT04003389|144776428|SUPERIORITY||LSMean difference|0.02|STANDARD_ERROR_OF_MEAN|0.023||0.386||95.0|-0.025|0.065||The LSM, SE, CI, and p-values come from an ANCOVA model with change from baseline at the Week 52 timepoint as response, treatment and smoking status (current vs former/never) as fixed effects with baseline weight and baseline as covariates.|ANCOVA|||Hip (Femur)||0.065|-0.025|0.386
72398216|NCT01853046|144302547|SUPERIORITY_OR_OTHER||LS-means|0.684|||||TWO_SIDED|90.0|0.397|1.18||||||Point estimates (LS-means) and 2-sided exploratory 90% confidence intervals for AUC(0-tlast) of metabolites M-2 calculated by re-transformation of the logarithmic data from ANOVAs.||1.18|0.397|
72473414|NCT01327846|144470615|SUPERIORITY|A HR \< 1 favors Canakinumab|Hazard Ratio (HR)|0.96||||0.597|TWO_SIDED|95.0|0.81|1.13||2-sided unadjusted p-value|Regression, Cox||All-cause mortality|||1.13|0.81|0.597
72473415|NCT02833077|144470686|SUPERIORITY||Responder Rate Difference|28.85||||0.0019|TWO_SIDED|95.0|11.16|45.6||If the 2-sided p-value is \< 0.05, the responder rate is greater for treatment than for control group, and point estimate of the responder rater for treatment group is greater than 50%, then treatment will be considered superior to control group.|Fisher's exact test|||Superiority of treatment group was established if responder rate at month 6 was statistically greater than that for the control group at month 6 and the observed responder rate at month 6 for the treatment group was greater than 50%.||45.60|11.16|0.0019
72473416|NCT02833077|144470687|OTHER||||||<|0.0001||||||P-value is based on a 2-sided paired t-test at the 5% level to demonstrate that the mean overall satisfaction score at month 6 visit is statistically greater than that at the baseline for the treatment group.|Two sided paired t-test|||||||<.0001
72507023|NCT03408873|144546107|OTHER||Mean Difference (Final Values)|-3.2||||0.63|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||We compared the repeated measure outcome across 2 time-points (difference between baseline \& week 24 to determine whether the population medians differed matched on participant with complete data. Of the 28 participants with baseline data only 11 had Week 24 data. Statistical Analysis was conducted for 11 participants with data at the 2 timepoints. The mean difference reported is not consistent with the mean values reported because only those with complete data were included in the analysis.||||0.63
72507024|NCT03408873|144546109|OTHER||Mean Difference (Final Values)|-10.7|||<|0.001|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||We compared the repeated measure outcome across 2 time-points (difference between baseline \& week 24 to determine whether the population medians differed matched on participant with complete data. Of the 30 participants with baseline data only 19 had Week 24 data. Statistical Analysis was conducted for 19 participants with data at the 2 timepoints. The mean difference reported is not consistent with the mean values reported because only those with complete data were included in the analysis.||||<0.001
72507025|NCT03408873|144546110|OTHER||Mean Difference (Final Values)|-8.4|||<|0.001|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||We compared the repeated measure outcome across 2 time-points (difference between screen \& week 24 to determine whether the population medians differed matched on participant with complete data. Of the 30 participants with screen data, only 19 had Week 24 data. Statistical Analysis was conducted for 19 participants with data at the 2 timepoints. Thus, the mean difference reported is not consistent with the mean values reported because only those with complete data were included in the analysis.||||<0.001
72507026|NCT03408873|144546110|OTHER||Mean Difference (Final Values)|-5.8|||<|0.001|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||We compared for the primary and secondary outcomes across two sets of time-points: 1) difference between screen and week 24, and 2) between baseline and week 24. A non-parametric Wilcoxon signed-rank test compared these repeated measurements (matched on participant) between these time-points to determine whether the population medians differed.||||<0.001
72507027|NCT03408873|144546111|OTHER||Mean Difference (Final Values)|-16.6|||<|0.001|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||We compared the repeated measure outcome across 2 time-points (difference between screen \& week 24 to determine whether the population medians differed matched on participant with complete data. Of the 30 participants with screen data, only 21 had Week 24 data. Statistical Analysis was conducted for 21 participants with data at the 2 timepoints. Thus, the mean difference reported is not consistent with the mean values reported because only those with complete data were included in the analysis.||||<0.001
72507028|NCT03408873|144546111|OTHER|We compared the repeated measure outcome across 2 time-points (difference between baseline \& week 24) to determine whether the population medians differed matched on participant with complete data. Of the 30 participants with baseline data, only 21 had Week 24 data. Statistical Analysis was conducted for 21 participants with data at the 2 timepoints. The mean difference reported is not consistent with the mean values reported because only those with complete data were included in the analysis.|Mean Difference (Final Values)|-8.1||||0.003|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||We compared for the primary and secondary outcomes across two sets of time-points: 1) difference between screen and week 24, and 2) between baseline and week 24. A non-parametric Wilcoxon signed-rank test compared these repeated measurements (matched on participant) between these time-points to determine whether the population medians differed.||||0.003
72398217|NCT01853046|144302547|SUPERIORITY_OR_OTHER||LS-means|0.446|||||TWO_SIDED|90.0|0.2|0.996||||||Point estimates (LS-means) and 2-sided exploratory 90% confidence intervals for AUC(0-tlast) of metabolites M-5 calculated by re-transformation of the logarithmic data from ANOVAs||0.996|0.200|
72473417|NCT01310231|144470690|SUPERIORITY||Hazard Ratio (HR)|1.2||||0.71|TWO_SIDED|95.0|0.63|2.31||One-sided p-value for group-effect obtained from Cox model. The prespecified threshold was 0.20 (one-sided).|Regression, Cox|Cox model for PFS with metf/plac and the two randomization stratification variables line of chemotherapy and hormone receptor status.|Ratio of hazard of progression in the Metformin group relative to hazard in the Placebo group|Power: Final study plan called for 40 progression events, giving 80% power to detect a hazard ratio (HR) of 0.58 for PFS with a one-sided type I error of 20%, where the relatively high type I error reflects the Phase II status of the trial||2.31|0.63|0.71
72507029|NCT03408873|144546112|OTHER|We compared the repeated measure outcome across 2 time-points (difference between screen \& week 24 to determine whether the population medians differed matched on participant with complete data.|Mean Difference (Final Values)|-1.8|||<|0.001|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.001
72507030|NCT03408873|144546112|OTHER||Mean Difference (Final Values)|-1.3|||<|0.001|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||We compared for the primary and secondary outcomes across two time-points: difference between baseline and week 24. A non-parametric Wilcoxon signed-rank test compared these repeated measurements (matched on participant with complete data) between these time-points to determine whether the population medians differed.||||<0.001
72565854|NCT02709486|144662724|SUPERIORITY||Odds Ratio (OR)|1.01||||0.9449|TWO_SIDED|95.0|0.72|1.42|||Regression, Logistic|||Week 24: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||1.42|0.72|0.9449
72398218|NCT02057198|144302586|SUPERIORITY||Slope|-0.15||||0.52|TWO_SIDED|95.0|-0.34|0.05||Data from the specified time points were combined to construct a decay slope, representing the reduction in log(CFUs)/day for each treatment group. We compared the slope (rate of change) between treatment groups using mixed effects models.|Mixed Models Analysis|A mixed effects model was used to compare decay slopes for the reduction in log(CFUs)/day according to each treatment group||||0.05|-0.34|0.52
72398219|NCT02057198|144302586|SUPERIORITY||Slope|-0.17||||0.66|TWO_SIDED|95.0|-0.69|0.35||Data from the specified time points were combined to construct a decay slope, representing the reduction in log(CFUs)/day for each treatment group. We compared the slope (rate of change) between treatment groups using mixed effects models.|Mixed Models Analysis|A mixed effects model was used to compare decay slopes for the reduction in log(CFUs)/day according to each treatment group||||0.35|-0.69|0.66
72398220|NCT02057198|144302587|SUPERIORITY||||||<|0.001|||||||Chi square (2 proportion test)|||||||<0.001
72398221|NCT02057198|144302587|SUPERIORITY|||||||0.01|||||||Chi square (2 proportion test)|||||||0.01
72473418|NCT01310231|144470691|SUPERIORITY||Odds Ratio (OR)|1.77||||0.41|TWO_SIDED|95.0|0.45|6.99||Two-side p-value from a logistic regression model.|Regression, Logistic|Logistic regression model included metf/plac and the two stratification variables line of chemotherapy and hormone receptor status.||||6.99|0.45|0.41
72473419|NCT04531982|144470727|SUPERIORITY|||||||0.4825||||||Two-sided p-value for treatment difference at Week 26 from MMRM analysis.|Mixed Models Analysis|||Difference between LSM changes for adjunctive pimavanserin and adjunctive placebo (pimavanserin - placebo) at the specified visit from MMRM analysis.||||0.4825
72473420|NCT04531982|144470728|SUPERIORITY|||||||0.8872||||||Two-sided p-value for treatment difference at Week 26 from MMRM analysis.|Mixed Models Analysis|||||||0.8872
72473421|NCT04854850|144470768|OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
72473422|NCT01123070|144470810|EQUIVALENCE|Bioequivalence declared if the back transformed 90% CI of geometric mean ratio is within the predefined limits of 0.75 to 1.33|Geometric mean ratio|0.93||||0.4265|TWO_SIDED|90.0|0.797|1.084|||ANCOVA|PK parameters were calculated using a logarithmic transformation. Covariates included body weight at screening, gender and treatment.|TL011 arm is the numerator and MabThera arm is the denominator|||1.084|0.797|0.4265
72473423|NCT01123070|144470811|EQUIVALENCE|Bioequivalence declared if the back transformed 90% CI of geometric mean ratio is within the predefined limits of 0.75 to 1.33|Geometric mean ratio|0.862||||0.0368|TWO_SIDED|90.0|0.768|0.968|||ANCOVA|PK parameters were calculated using a logarithmic transformation. Covariates included body weight at screening, gender and treatment.|TL011 arm is the numerator, MabThera arm is the denominator|||0.968|0.768|0.0368
72623074|NCT04003389|144776428|SUPERIORITY||LSMean difference|0.041|STANDARD_ERROR_OF_MEAN|0.029||0.156||95.0|-0.016|0.099||The LSM, SE, CI, and p-values come from an ANCOVA model with change from baseline at the Week 52 timepoint as response, treatment and smoking status (current vs former/never) as fixed effects with baseline weight and baseline as covariates.|ANCOVA|||Hip (Trochanter)||0.099|-0.016|0.156
72398222|NCT02057198|144302588|SUPERIORITY|||||||0.99|||||||Chi square (2 proportion test)|||||||0.99
72398223|NCT02057198|144302588|SUPERIORITY|||||||0.52|||||||Chi square (2 proportion test)|||||||0.52
72473424|NCT01123070|144470813|EQUIVALENCE|Bioequivalence declared if the 90% CI of geometric mean ratio is within the predefined limits of 0.75 to 1.33|Geometric mean ratio|0.909||||0.1484|TWO_SIDED|90.0|0.814|1.014|||ANCOVA|PK parameters were calculated using a logarithmic transformation. Covariates included body weight at screening, gender and treatment.|TL011/MabThera|Cmax1||1.014|0.814|0.1484
72473425|NCT01123070|144470813|EQUIVALENCE|Bioequivalence declared if the 90% CI of geometric mean ratio is within the predefined limits of 0.75 to 1.33|Geometric mean ratio|0.766||||0.0241|TWO_SIDED|90.0|0.633|0.927|||ANCOVA|PK parameters were calculated using a logarithmic transformation. Covariates included body weight at screening, gender and treatment.|TL011/MabThera|Cmax2||0.927|0.633|0.0241
72473426|NCT01123070|144470814|EQUIVALENCE|Bioequivalence declared if the 90% CI of geometric mean ratio is within the predefined limits of 0.75 to 1.33|Geometric mean ratio|0.969||||0.652|TWO_SIDED|90.0|0.863|1.088|||ANCOVA|PK parameters were calculated using a logarithmic transformation. Covariates included body weight at screening, gender and treatment.|TL011 arm is the numerator, MabThera arm is the denominator|AUC1||1.088|0.863|0.6520
72473427|NCT01123070|144470814|EQUIVALENCE|Bioequivalence declared if the 90% CI of geometric mean ratio is within the predefined limits of 0.75 to 1.33|Geometric mean ratio|0.961||||0.7835|TWO_SIDED|90.0|0.757|1.222|||ANCOVA|PK parameters were calculated using a logarithmic transformation. Covariates included body weight at screening, gender and treatment.|TL011/MabThera|AUC2||1.222|0.757|0.7835
72398224|NCT02057198|144302589|SUPERIORITY||Slope|-0.43||||0.05|TWO_SIDED|95.0|-0.67|-0.19|||Mixed Models Analysis|A mixed effects model was used to compare decay slopes for the reduction in log(CFUs)/day according to each treatment group||Data from the specified time points were combined to construct a decay slope, representing the reduction in log(CFUs)/day for each treatment group. We compared the slope (rate of change) between treatment groups using mixed effects models. Data from the specified time points were combined to construct a decay slope, representing the reduction in log(CFUs)/day for each treatment group. We compared the slope (rate of change) between treatment groups using mixed effects models.||-0.19|-0.67|0.05
72398225|NCT02057198|144302589|SUPERIORITY||Slope|-0.85||||0.002|TWO_SIDED|95.0|-1.14|-0.57|||Mixed Models Analysis|A mixed effects model was used to compare decay slopes for the reduction in log(CFUs)/day according to each treatment group||Data from the specified time points were combined to construct a decay slope, representing the reduction in log(CFUs)/day for each treatment group. We compared the slope (rate of change) between treatment groups using mixed effects models. Data from the specified time points were combined to construct a decay slope, representing the reduction in log(CFUs)/day for each treatment group. We compared the slope (rate of change) between treatment groups using mixed effects models.||-0.57|-1.14|0.002
72398226|NCT02057198|144302591|SUPERIORITY|||||||0.48|||||||Chi square (two proportion test)|||||||0.48
72398227|NCT02057198|144302591|SUPERIORITY|||||||0.66|||||||Chi square (two proportion test)|||||||0.66
72398228|NCT01985581|144302592|SUPERIORITY_OR_OTHER||LS mean difference|-3.0||||0.0392|TWO_SIDED|95.0|-5.9|-0.2|||ANOVA|||||-0.2|-5.9|0.0392
72398229|NCT01985581|144302593|SUPERIORITY_OR_OTHER||LS mean difference|0.3||||0.894|TWO_SIDED|95.0|-4.0|4.6|||ANOVA|||||4.6|-4.0|0.894
72473428|NCT04833127|144470853|EQUIVALENCE|Null hypothesis: no difference between the groups|Odds Ratio (OR)|1.0||||1|TWO_SIDED|95.0|0.56|1.8||generalized linear models (GLM) and generalized estimating equations (GEE) for clustering within recruitment chain|GLM (logit link) with GEE|||||1.80|0.56|1.0
72473429|NCT04833127|144470853|EQUIVALENCE|Null H: No difference between the groups|Odds Ratio (OR)|1.13||||0.69|TWO_SIDED|95.0|0.62|2.07||GLM with GEE to account for clustering by recruitment chain.|GLM (logit link) with GEE|Adjusted for age, education, if has a main male partner, which differed between the two groups at baseline.||||2.07|0.62|0.69
72473430|NCT04833127|144470854|EQUIVALENCE|Null hypothesis: No difference between the groups.|Odds Ratio (OR)|1.0||||1|TWO_SIDED|95.0|0.35|2.85|||GLM with GEE|GLM with GEE accounting for clustering by recruitment chain||||2.85|0.35|1.00
72473431|NCT04833127|144470854|EQUIVALENCE|Null H: No difference between the 2 groups|Odds Ratio (OR)|0.95||||0.927|TWO_SIDED|95.0|0.31|2.9||GLM (logit link) with GEE to account for clustering by recruitment chain|GLM (logit link) with GEE|adjusted for baseline differences in age, educational status, and whether has a primary male partner.||||2.90|0.31|0.927
72473432|NCT04833127|144470855|EQUIVALENCE|Null Hypothesis: No difference between the groups|Odds Ratio (OR)|1.72||||0.215|TWO_SIDED|95.0|0.73|4.04|||GLM (logit link) with GEE|Used GEE to account for clustering by recruitment chain.||||4.04|0.73|0.215
72473433|NCT04833127|144470855|EQUIVALENCE|Null hypothesis: No difference between the groups|Odds Ratio (OR)|1.64||||0.295|TWO_SIDED|95.0|0.65|4.13|||GLM (logit link) with GEE|GEE used to account for clustering by recruitment chain|adjusted for baseline differences in age, education, and whether has a main male partner.|||4.13|0.65|0.295
72473434|NCT04552899|144470860|SUPERIORITY||Difference in Change from Baseline|-20.83|STANDARD_ERROR_OF_MEAN|34.11||0.54|TWO_SIDED|95.0|-87.94|46.29|||RCRM|Random Coefficient Regression Model (RCRM)||||46.29|-87.94|0.54
72473435|NCT04552899|144470863|SUPERIORITY||Hazard Ratio (HR)|1.15||||0.2512|TWO_SIDED|95.0|0.91|1.47|||Log Rank|||||1.47|0.91|0.2512
72473436|NCT04552899|144470864|SUPERIORITY||Hazard Ratio (HR)|1.01||||0.9833|TWO_SIDED|95.0|0.51|1.97|||Log Rank|||||1.97|0.51|0.9833
72507031|NCT03408873|144546113|OTHER||Mean Difference (Final Values)|0.8||||0.0566|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||We compared for the primary and secondary outcomes across two sets of time-points: 1) difference between screen and week 24, and 2) between baseline and week 24. A non-parametric Wilcoxon signed-rank test compared these repeated measurements (matched on participant) between these time-points to determine whether the population medians differed.||||0.0566
72473437|NCT04552899|144470867|SUPERIORITY||Hazard Ratio (HR)|0.86||||0.7005|TWO_SIDED|95.0|0.4|1.86|||Log Rank|||||1.86|0.40|0.7005
72473438|NCT00461981|144470882|SUPERIORITY_OR_OTHER_LEGACY||Rate differences|-60.6||||||95.0|-79.7|-31.7||||||The seroconversion rates (the proportions of baseline seronegative subjects achieving a 4 or more fold increase in titer from baseline) were summarized for baseline seronegative subjects by treatment group and by dose number. A two-sided exact 95% confidence interval (CI) was constructed on the rate differences using the unconditional exact method proposed by Chan and Zhang (Chan, 1999).||-31.7|-79.7|
72473439|NCT00461981|144470883|SUPERIORITY_OR_OTHER_LEGACY||Rate differences|-60.9||||||95.0|-83.8|-26.0||||||The seroconversion rates (the proportions of baseline seronegative subjects achieving a 4 or more fold increase in titer from baseline) were summarized for baseline seronegative subjects by treatment group and by dose number. A two-sided exact 95% confidence interval (CI) was constructed on the rate differences using the unconditional exact method proposed by Chan and Zhang (Chan, 1999).||-26.0|-83.8|
72473440|NCT00461981|144470884|SUPERIORITY_OR_OTHER_LEGACY||Rate differences|44.2||||||95.0|12.0|67.8||||||The seroconversion rates (the proportions of baseline seronegative subjects achieving a 4 or more fold increase in titer from baseline) were summarized for baseline seronegative subjects by treatment group and by dose number. A two-sided exact 95% confidence interval (CI) was constructed on the rate differences using the unconditional exact method proposed by Chan and Zhang (Chan, 1999).||67.8|12.0|
72473441|NCT00461981|144470885|SUPERIORITY_OR_OTHER_LEGACY||Rate differences|16.2||||||95.0|-17.6|45.4||||||The seroconversion rates (the proportions of baseline seronegative subjects achieving a 4 or more fold increase in titer from baseline) were summarized for baseline seronegative subjects by treatment group and by dose number. A two-sided exact 95% confidence interval (CI) was constructed on the rate differences using the unconditional exact method proposed by Chan and Zhang (Chan, 1999).||45.4|-17.6|
72473442|NCT00461981|144470886|SUPERIORITY_OR_OTHER_LEGACY||Rate differences|-18.2||||||95.0|-40.0|4.9||||||The seroconversion rates (the proportions of baseline seronegative subjects achieving a 4 or more fold increase in titer from baseline) were summarized for baseline seronegative subjects by treatment group and by dose number. A two-sided exact 95% confidence interval (CI) was constructed on the rate differences using the unconditional exact method proposed by Chan and Zhang (Chan, 1999).||4.9|-40.0|
72473443|NCT00461981|144470887|SUPERIORITY_OR_OTHER_LEGACY||Rate differences|-5.6||||||95.0|-27.4|13.3||||||The seroconversion rates (the proportions of baseline seronegative subjects achieving a 4 or more fold increase in titer from baseline) were summarized for baseline seronegative subjects by treatment group and by dose number. A two-sided exact 95% confidence interval (CI) was constructed on the rate differences using the unconditional exact method proposed by Chan and Zhang (Chan, 1999).||13.3|-27.4|
72473444|NCT00461981|144470888|SUPERIORITY_OR_OTHER_LEGACY||Rate differences|35.7||||||95.0|9.5|57.1||||||The seroconversion rates (the proportions of baseline seronegative subjects achieving a 4 or more fold increase in titer from baseline) were summarized for baseline seronegative subjects by treatment group and by dose number. A two-sided exact 95% confidence interval (CI) was constructed on the rate differences using the unconditional exact method proposed by Chan and Zhang (Chan, 1999).||57.1|9.5|
72473445|NCT00461981|144470889|SUPERIORITY_OR_OTHER_LEGACY||Rate differences|-5.0||||||95.0|-27.7|16.0||||||The seroconversion rates (the proportions of baseline seronegative subjects achieving a 4 or more fold increase in titer from baseline) were summarized for baseline seronegative subjects by treatment group and by dose number. A two-sided exact 95% confidence interval (CI) was constructed on the rate differences using the unconditional exact method proposed by Chan and Zhang (Chan, 1999).||16.0|-27.7|
72473446|NCT00461981|144470890|SUPERIORITY_OR_OTHER_LEGACY||Rate differences|14.7||||||95.0|-6.5|38.4||||||The seroconversion rates (the proportions of baseline seronegative subjects achieving a 4 or more fold increase in titer from baseline) were summarized for baseline seronegative subjects by treatment group and by dose number. A two-sided exact 95% confidence interval (CI) was constructed on the rate differences using the unconditional exact method proposed by Chan and Zhang (Chan, 1999).||38.4|-6.5|
72473447|NCT00461981|144470891|SUPERIORITY_OR_OTHER_LEGACY||Rate differences|38.1||||||95.0|0.9|65.9||||||The seroconversion rates (the proportions of baseline seronegative subjects achieving a 4 or more fold increase in titer from baseline) were summarized for baseline seronegative subjects by treatment group and by dose number. A two-sided exact 95% confidence interval (CI) was constructed on the rate differences using the unconditional exact method proposed by Chan and Zhang (Chan, 1999).||65.9|0.9|
72473448|NCT00461981|144470892|SUPERIORITY_OR_OTHER_LEGACY||Rate differences|11.7||||||95.0|-13.0|34.9||||||The seroconversion rates (the proportions of baseline seronegative subjects achieving a 4 or more fold increase in titer from baseline) were summarized for baseline seronegative subjects by treatment group and by dose number. A two-sided exact 95% confidence interval (CI) was constructed on the rate differences using the unconditional exact method proposed by Chan and Zhang (Chan, 1999).||34.9|-13.0|
72473449|NCT00461981|144470893|SUPERIORITY_OR_OTHER_LEGACY||Rate differences|-15.8||||||95.0|-40.7|8.0||||||The seroconversion rates (the proportions of baseline seronegative subjects achieving a 4 or more fold increase in titer from baseline) were summarized for baseline seronegative subjects by treatment group and by dose number. A two-sided exact 95% confidence interval (CI) was constructed on the rate differences using the unconditional exact method proposed by Chan and Zhang (Chan, 1999).||8.0|-40.7|
72473450|NCT00461981|144470894|SUPERIORITY_OR_OTHER_LEGACY||GMT ratio|0.43||||||95.0|0.24|0.87||||||Corresponding two-sided 95% CIs based on 10,000 bootstrap data sets for the ratios of strain-specific GMTs (FluMist/TIV) were constructed by drawing replicates with replacement from each of the 2 cells (2 treatment groups) of observed data. The number of replicates drawn from each cell in this fashion was equal to the observed sample size within each cell. For each of the 10,000 bootstrap data sets, the overall GMT ratio was calculated.||0.87|0.24|
72473451|NCT00461981|144470895|SUPERIORITY_OR_OTHER_LEGACY||GMT Ratio|0.2||||||95.0|0.09|0.48||||||Corresponding two-sided 95% CIs based on 10,000 bootstrap data sets for the ratios of strain-specific GMTs (FluMist/TIV) were constructed by drawing replicates with replacement from each of the 2 cells (2 treatment groups) of observed data. The number of replicates drawn from each cell in this fashion was equal to the observed sample size within each cell. For each of the 10,000 bootstrap data sets, the overall GMT ratio was calculated.||0.48|0.09|
72473452|NCT00461981|144470896|SUPERIORITY_OR_OTHER_LEGACY||GMT Ratio|3.36||||||95.0|1.54|7.13||||||The seroconversion rates (the proportions of baseline seronegative subjects achieving a 4 or more fold increase in titer from baseline) were summarized for baseline seronegative subjects by treatment group and by dose number. A two-sided exact 95% confidence interval (CI) was constructed on the rate differences using the unconditional exact method proposed by Chan and Zhang (Chan, 1999).||7.13|1.54|
72473453|NCT00461981|144470897|SUPERIORITY_OR_OTHER_LEGACY||GMT ratio|3.26||||||95.0|1.44|7.19||||||Corresponding two-sided 95% CIs based on 10,000 bootstrap data sets for the ratios of strain-specific GMTs (FluMist/TIV) were constructed by drawing replicates with replacement from each of the 2 cells (2 treatment groups) of observed data. The number of replicates drawn from each cell in this fashion was equal to the observed sample size within each cell. For each of the 10,000 bootstrap data sets, the overall GMT ratio was calculated.||7.19|1.44|
72473454|NCT00461981|144470898|SUPERIORITY_OR_OTHER_LEGACY||GMT Ratio|1.06||||||95.0|0.56|1.96||||||Corresponding two-sided 95% CIs based on 10,000 bootstrap data sets for the ratios of strain-specific GMTs (FluMist/TIV) were constructed by drawing replicates with replacement from each of the 2 cells (2 treatment groups) of observed data. The number of replicates drawn from each cell in this fashion was equal to the observed sample size within each cell. For each of the 10,000 bootstrap data sets, the overall GMT ratio was calculated.||1.96|0.56|
72473455|NCT00461981|144470899|SUPERIORITY_OR_OTHER_LEGACY||GMT Ratio|0.58||||||95.0|0.31|1.12||||||Corresponding two-sided 95% CIs based on 10,000 bootstrap data sets for the ratios of strain-specific GMTs (FluMist/TIV) were constructed by drawing replicates with replacement from each of the 2 cells (2 treatment groups) of observed data. The number of replicates drawn from each cell in this fashion was equal to the observed sample size within each cell. For each of the 10,000 bootstrap data sets, the overall GMT ratio was calculated.||1.12|0.31|
72507032|NCT03408873|144546114|OTHER||Mean Difference (Final Values)|-3.4|||<|0.001|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||We compared for the primary and secondary outcomes across two time-points: difference between screen and week 24. A non-parametric Wilcoxon signed-rank test compared these repeated measurements (matched on participant with complete data) between these time-points to determine whether the population medians differed.||||<0.001
72398230|NCT01985581|144302594|SUPERIORITY_OR_OTHER||LS mean difference|-6.2||||0.0001|TWO_SIDED|95.0|-9.1|-3.2|||ANOVA|||||-3.2|-9.1|0.0001
72398231|NCT01985581|144302596|SUPERIORITY_OR_OTHER||LS mean difference|0.3||||0.8706|TWO_SIDED|95.0|-3.2|3.7|||ANOVA|||||3.7|-3.2|0.8706
72473456|NCT00461981|144470900|SUPERIORITY_OR_OTHER_LEGACY||GMT Ratio|2.4||||||95.0|1.48|3.97||||||Corresponding two-sided 95% CIs based on 10,000 bootstrap data sets for the ratios of strain-specific GMTs (FluMist/TIV) were constructed by drawing replicates with replacement from each of the 2 cells (2 treatment groups) of observed data. The number of replicates drawn from each cell in this fashion was equal to the observed sample size within each cell. For each of the 10,000 bootstrap data sets, the overall GMT ratio was calculated.||3.97|1.48|
72473457|NCT00461981|144470901|SUPERIORITY_OR_OTHER_LEGACY||GMT Ratio|0.48||||||95.0|0.27|0.87||||||Corresponding two-sided 95% CIs based on 10,000 bootstrap data sets for the ratios of strain-specific GMTs (FluMist/TIV) were constructed by drawing replicates with replacement from each of the 2 cells (2 treatment groups) of observed data. The number of replicates drawn from each cell in this fashion was equal to the observed sample size within each cell. For each of the 10,000 bootstrap data sets, the overall GMT ratio was calculated.||0.87|0.27|
72473458|NCT00461981|144470902|SUPERIORITY_OR_OTHER_LEGACY||GMT Ratio|1.45||||||95.0|0.8|2.66||||||Corresponding two-sided 95% CIs based on 10,000 bootstrap data sets for the ratios of strain-specific GMTs (FluMist/TIV) were constructed by drawing replicates with replacement from each of the 2 cells (2 treatment groups) of observed data. The number of replicates drawn from each cell in this fashion was equal to the observed sample size within each cell. For each of the 10,000 bootstrap data sets, the overall GMT ratio was calculated.||2.66|0.80|
72473459|NCT00461981|144470903|SUPERIORITY_OR_OTHER_LEGACY||GMT Ratio|1.75||||||95.0|0.88|3.39||||||Corresponding two-sided 95% CIs based on 10,000 bootstrap data sets for the ratios of strain-specific GMTs (FluMist/TIV) were constructed by drawing replicates with replacement from each of the 2 cells (2 treatment groups) of observed data. The number of replicates drawn from each cell in this fashion was equal to the observed sample size within each cell. For each of the 10,000 bootstrap data sets, the overall GMT ratio was calculated.||3.39|0.88|
72473460|NCT00461981|144470904|SUPERIORITY_OR_OTHER_LEGACY||GMT Ratio|1.49||||||95.0|0.8|2.69||||||Corresponding two-sided 95% CIs based on 10,000 bootstrap data sets for the ratios of strain-specific GMTs (FluMist/TIV) were constructed by drawing replicates with replacement from each of the 2 cells (2 treatment groups) of observed data. The number of replicates drawn from each cell in this fashion was equal to the observed sample size within each cell. For each of the 10,000 bootstrap data sets, the overall GMT ratio was calculated.||2.69|0.80|
72473461|NCT00461981|144470905|SUPERIORITY_OR_OTHER_LEGACY||GMT Ratio|0.62||||||95.0|0.33|1.16||||||Corresponding two-sided 95% CIs based on 10,000 bootstrap data sets for the ratios of strain-specific GMTs (FluMist/TIV) were constructed by drawing replicates with replacement from each of the 2 cells (2 treatment groups) of observed data. The number of replicates drawn from each cell in this fashion was equal to the observed sample size within each cell. For each of the 10,000 bootstrap data sets, the overall GMT ratio was calculated.||1.16|0.33|
72507033|NCT03408873|144546115|OTHER||Mean Difference (Final Values)|17.7|||<|0.001|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||We compared the repeated measure outcome across 2 time-points (difference between screen \& week 24 to determine whether the population medians differed matched on participant with complete data. Of the 30 participants with screen data, only 21 had Week 24 data. Statistical Analysis was conducted for 21 participants with data at the 2 timepoints. Thus, the mean difference reported is not consistent with the mean values reported because only those with complete data were included in the analysis.||||<0.001
72507034|NCT03408873|144546116|OTHER||Mean Difference (Final Values)|16.9|||<|0.001|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||We compared the repeated measure outcome across 2 time-points (difference between baseline \& week 24 to determine whether the population medians differed matched on participant with complete data. Of the 30 participants with baseline data, only 21 had Week 24 data. Statistical Analysis was conducted for 21 participants with data at the 2 timepoints. The mean difference reported is not consistent with the mean values reported because only those with complete data were included in the analysis.||||<0.001
72507035|NCT03408873|144546117|OTHER||Mean Difference (Final Values)|14.7|||<|0.001|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||We compared the repeated measure outcome across 2 time-points (difference between screen \& week 24 to determine whether the population medians differed matched on participant with complete data. Of the 29 participants with screen data, only 21 had Week 24 data. Statistical Analysis was conducted for 21 participants with data at the 2 timepoints. Thus, the mean difference reported is not consistent with the mean values reported because only those with complete data were included in the analysis.||||<0.001
72507036|NCT03408873|144546118|OTHER||Mean Difference (Final Values)|19.2|||<|0.001|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||We compared the repeated measure outcome across 2 time-points (difference between screen \& week 24 to determine whether the population medians differed matched on participant with complete data. Of the 30 participants with screen data, only 21 had Week 24 data. Statistical Analysis was conducted for 21 participants with data at the 2 timepoints. Thus, the mean difference reported is not consistent with the mean values reported because only those with complete data were included in the analysis.||||<0.001
72507037|NCT03408873|144546119|OTHER||Mean Difference (Final Values)|-0.5||||0.73|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||We compared the repeated measure outcome across 2 time-points (difference between screen \& week 24 to determine whether the population medians differed matched on participant with complete data. Of the 30 participants with screen data, only 21 had Week 24 data. Statistical Analysis was conducted for 21 participants with data at the 2 timepoints. Thus, the mean difference reported is not consistent with the mean values reported because only those with complete data were included in the analysis.||||0.73
72507038|NCT03408873|144546120|OTHER||Mean Difference (Final Values)|-10.7||||0.02|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||We compared the repeated measure outcome across 2 time-points (difference between screen \& week 24 to determine whether the population medians differed matched on participant with complete data. Of the 30 participants with screen data, only 21 had Week 24 data. Statistical Analysis was conducted for 21 participants with data at the 2 timepoints. Thus, the mean difference reported is not consistent with the mean values reported because only those with complete data were included in the analysis.||||0.02
72507039|NCT01600131|144546121|SUPERIORITY||Slope|-0.68|STANDARD_ERROR_OF_MEAN|1.72||0.693|TWO_SIDED|||||a priori \<.05 threshold|Mixed Models Analysis||group X time interaction|||||0.693
72507040|NCT01600131|144546122|SUPERIORITY||Slope|-2.17|STANDARD_ERROR_OF_MEAN|2.07||0.693|TWO_SIDED|||||a priori \<.05 threshold|Mixed Models Analysis||group x time interaction|||||0.693
72507041|NCT01600131|144546123|SUPERIORITY||Slope|-2.08|STANDARD_ERROR_OF_MEAN|1.08||0.055|TWO_SIDED||||||Mixed Models Analysis||group X time interaction|||||0.055
72507042|NCT01600131|144546124|SUPERIORITY||Slope|-1.08|STANDARD_ERROR_OF_MEAN|1.15||0.346|TWO_SIDED||||||Mixed Models Analysis||group X time interaction|||||0.346
72507043|NCT01600131|144546126|SUPERIORITY||Slope|-0.72|STANDARD_ERROR_OF_MEAN|1.79||0.688|TWO_SIDED|||||a priori \<0.05|Mixed Models Analysis||group X time interaction|||||0.688
72507044|NCT01600131|144546127|SUPERIORITY||Slope|-1.52|STANDARD_ERROR_OF_MEAN|1.87||0.418|TWO_SIDED|||||a priori \<.05|Mixed Models Analysis||group X time interaction|||||0.418
72507045|NCT01600131|144546128|SUPERIORITY||Slope|-1.94|STANDARD_ERROR_OF_MEAN|1.45||0.18|TWO_SIDED|||||a priori \<0.05|Mixed Models Analysis||group X time interaction|||||0.180
72507046|NCT01600131|144546129|SUPERIORITY||Slope|-0.63|STANDARD_ERROR_OF_MEAN|0.65||0.332|TWO_SIDED||||||Mixed Models Analysis||group X time interaction|||||0.332
72507047|NCT01600131|144546130|SUPERIORITY||Slope|-0.56|STANDARD_ERROR_OF_MEAN|0.56||0.318|TWO_SIDED|||||a priori \<0.05|Mixed Models Analysis||group X time interaction|||||0.318
72507048|NCT01600131|144546131|SUPERIORITY||Slope|2.33|STANDARD_ERROR_OF_MEAN|1.31||0.077|TWO_SIDED|||||a priori \<.05|Mixed Models Analysis||group X time interaction|||||0.077
72507049|NCT01600131|144546132|SUPERIORITY||Slope|1.5|STANDARD_ERROR_OF_MEAN|1.46||0.305|TWO_SIDED|||||a priori \<0.05|Mixed Models Analysis||group X time interaction|||||0.305
72507050|NCT01600131|144546135|SUPERIORITY||Slope|-0.62|STANDARD_ERROR_OF_MEAN|0.94||0.514|TWO_SIDED|||||a priori \<0.05|Mixed Models Analysis||group X time interaction|||||0.514
72473462|NCT00461981|144470906|SUPERIORITY_OR_OTHER_LEGACY||Rate differences|-45.9||||||95.0|-71.7|-11.6||||||The seroconversion rates (the proportions of baseline seronegative subjects achieving a 4 or more fold increase in titer from baseline) were summarized for baseline seronegative subjects by treatment group and by dose number. A two-sided exact 95% confidence interval (CI) was constructed on the rate differences using the unconditional exact method proposed by Chan and Zhang (Chan, 1999).||-11.6|-71.7|
72398232|NCT03878745|144302600|SUPERIORITY|Two-sided 95% confidence intervals is calculated for the average relative rating. A linear model was used to evaluate the pen needle group effect on the response to test whether the groups can be combined and to adjust for the order effect. The order of the pen needles used and the group to which the subject belongs were used as covariates. If the lower bound of the CI is \> 0, we can conclude in superiority.|Overall Mean|0.21|||||TWO_SIDED|95.0|0.07|0.35||||||||0.35|0.07|
72398233|NCT03878745|144302601|OTHER||Mean Difference (Final Values)|0.0|||||TWO_SIDED|95.0|-1.6|1.6||||||||1.6|-1.6|
72398234|NCT03878745|144302602|OTHER||Mean Difference (Final Values)|-1.5|||||TWO_SIDED|95.0|-3.6|0.1||||||||0.1|-3.6|
72473463|NCT00461981|144470907|SUPERIORITY_OR_OTHER_LEGACY||Rate difference|-25.0||||||95.0|-57.2|4.8||||||The seroconversion rates (the proportions of baseline seronegative subjects achieving a 4 or more fold increase in titer from baseline) were summarized for baseline seronegative subjects by treatment group and by dose number. A two-sided exact 95% confidence interval (CI) was constructed on the rate differences using the unconditional exact method proposed by Chan and Zhang (Chan, 1999).||4.8|-57.2|
72473464|NCT00461981|144470908|SUPERIORITY_OR_OTHER_LEGACY||Rate difference|65.0||||||95.0|34.4|85.3||||||The seroconversion rates (the proportions of baseline seronegative subjects achieving a 4 or more fold increase in titer from baseline) were summarized for baseline seronegative subjects by treatment group and by dose number. A two-sided exact 95% confidence interval (CI) was constructed on the rate differences using the unconditional exact method proposed by Chan and Zhang (Chan, 1999).||85.3|34.4|
72473465|NCT00461981|144470909|SUPERIORITY_OR_OTHER_LEGACY||Rate difference|-0.6||||||95.0|-30.4|30.3||||||The seroconversion rates (the proportions of baseline seronegative subjects achieving a 4 or more fold increase in titer from baseline) were summarized for baseline seronegative subjects by treatment group and by dose number. A two-sided exact 95% confidence interval (CI) was constructed on the rate differences using the unconditional exact method proposed by Chan and Zhang (Chan, 1999).||30.3|-30.4|
72507051|NCT01600131|144546136|SUPERIORITY||Slope|-1.61|STANDARD_ERROR_OF_MEAN|0.94||0.09|TWO_SIDED|||||a priori \<0.05|Mixed Models Analysis||group X time interaction|||||0.090
72507052|NCT01600131|144546137|SUPERIORITY||Slope|6.71|STANDARD_ERROR_OF_MEAN|2.57||0.009|TWO_SIDED|||||a priori \<0.05|Mixed Models Analysis||group X time interaction|||||0.009
72507053|NCT01600131|144546138|SUPERIORITY||Slope|4.29|STANDARD_ERROR_OF_MEAN|3.53||0.225|TWO_SIDED||||||Mixed Models Analysis||group X time interaction|||||0.225
72507054|NCT01600131|144546139|SUPERIORITY||Slope|3.75|STANDARD_ERROR_OF_MEAN|4.89||0.443|TWO_SIDED|||||a priori \<.05 threshold|Mixed Models Analysis||group X time interaction|||||0.443
72507055|NCT01600131|144546140|SUPERIORITY||Slope|7.39|STANDARD_ERROR_OF_MEAN|5.23||0.158|TWO_SIDED||||||Mixed Models Analysis||group x time interaction|||||0.158
72398235|NCT03878745|144302603|SUPERIORITY|A mixed effect model was used (fixed effects of PN, abdomen site, order of pair, order of PN within pair and random subject effect) to estimate average difference (BD Nano PN - Terumo PN) in delivery time and total injection time. A Box-Cox transformation might be used to normalize the data if necessary.|Median Difference (Final Values)|-0.5|||<|0.001|ONE_SIDED|95.0||-0.026|||Mixed Models Analysis|||||-0.026||<0.001
72398236|NCT03878745|144302604|OTHER||Mean Difference (Final Values)|0.0|||||TWO_SIDED|95.0|-1.2|1.2||||||||1.2|-1.2|
72398237|NCT01172847|144302628|SUPERIORITY_OR_OTHER||mean exposure ratio|0.98|||||TWO_SIDED|90.0|0.91|1.05|||||Estimate of the treatment difference and corresponding 90% CI was derived from the back-transformed model.|Mean exposure ratio of oseltamivir||1.05|0.91|
72398238|NCT01172847|144302628|SUPERIORITY_OR_OTHER||mean exposure ratio|0.98|||||TWO_SIDED|90.0|0.95|1.02|||||Estimate of the treatment difference and corresponding 90% CI was derived from the back-transformed model.|Mean exposure ratio of oseltamivir carboxylate||1.02|0.95|
72398239|NCT01172847|144302629|SUPERIORITY_OR_OTHER||mean exposure ratio|1.03|||||TWO_SIDED|90.0|1.0|1.06|||||Estimate of the treatment difference and corresponding 90% CI was derived from the back-transformed model.|Mean exposure ratio of rimantadine||1.06|1.00|
72398240|NCT01172847|144302630|SUPERIORITY_OR_OTHER||mean exposure ratio|0.86|||||TWO_SIDED|90.0|0.77|0.96|||||Estimate of the treatment difference and corresponding 90% CI was derived from the back-transformed model.|Mean exposure ratio of oseltamivir||0.96|0.77|
72398241|NCT01172847|144302630|SUPERIORITY_OR_OTHER||mean exposure ratio|0.98|||||TWO_SIDED|90.0|0.92|1.05|||||Estimate of the treatment difference and corresponding 90% CI was derived from the back-transformed model.|Mean exposure ratio of oseltamivir carboxylate||1.05|0.92|
72507056|NCT01600131|144546141|SUPERIORITY||Slope|7.28|STANDARD_ERROR_OF_MEAN|3.64||0.046|TWO_SIDED|||||a priori \<.05 threshold|Mixed Models Analysis||group X time interaction|||||0.046
72398242|NCT01172847|144302631|SUPERIORITY_OR_OTHER||mean exposure ratio|1.03|||||TWO_SIDED|90.0|0.99|1.06|||||Estimate of the treatment difference and corresponding 90% CI was derived from the back-transformed model.|mean exposure ratio of rimantadine||1.06|0.99|
72473466|NCT00461981|144470910|SUPERIORITY_OR_OTHER_LEGACY||Rate difference|-37.0||||||95.0|-57.8|-17.5||||||The seroconversion rates (the proportions of baseline seronegative subjects achieving a 4 or more fold increase in titer from baseline) were summarized for baseline seronegative subjects by treatment group and by dose number. A two-sided exact 95% confidence interval (CI) was constructed on the rate differences using the unconditional exact method proposed by Chan and Zhang (Chan, 1999).||-17.5|-57.8|
72473467|NCT00461981|144470911|SUPERIORITY_OR_OTHER_LEGACY||Rate difference|-8.3||||||95.0|-38.5|14.5||||||The seroconversion rates (the proportions of baseline seronegative subjects achieving a 4 or more fold increase in titer from baseline) were summarized for baseline seronegative subjects by treatment group and by dose number. A two-sided exact 95% confidence interval (CI) was constructed on the rate differences using the unconditional exact method proposed by Chan and Zhang (Chan, 1999).||14.5|-38.5|
72507057|NCT01600131|144546142|SUPERIORITY||Slope|5.54|STANDARD_ERROR_OF_MEAN|3.83||0.149|TWO_SIDED||||||Mixed Models Analysis||group X time interaction|||||0.149
72507058|NCT01600131|144546143|SUPERIORITY||Slope|4.16|STANDARD_ERROR_OF_MEAN|1.95||0.034|TWO_SIDED|||||a priori \<0.05|Mixed Models Analysis||group X time interaction|||||0.034
72507059|NCT01600131|144546144|SUPERIORITY||Slope|-0.3|STANDARD_ERROR_OF_MEAN|1.52||0.846|TWO_SIDED|||||a priori \<0.05|Mixed Models Analysis||group X time interaction|||||0.846
72507060|NCT01600131|144546145|SUPERIORITY||Slope|1.67|STANDARD_ERROR_OF_MEAN|2.17||0.0442|TWO_SIDED|||||a priori \<0.05|Mixed Models Analysis||group X time interaction|||||.0442
72507061|NCT01600131|144546146|SUPERIORITY||Slope|1.98|STANDARD_ERROR_OF_MEAN|1.88||0.293|TWO_SIDED|||||a priori \<0.05|Mixed Models Analysis||group X time interaction|||||0.293
72473468|NCT00461981|144470912|SUPERIORITY_OR_OTHER_LEGACY||Rate difference|21.9||||||95.0|-6.7|48.1||||||The seroconversion rates (the proportions of baseline seronegative subjects achieving a 4 or more fold increase in titer from baseline) were summarized for baseline seronegative subjects by treatment group and by dose number. A two-sided exact 95% confidence interval (CI) was constructed on the rate differences using the unconditional exact method proposed by Chan and Zhang (Chan, 1999).||48.1|-6.7|
72473469|NCT00461981|144470913|SUPERIORITY_OR_OTHER_LEGACY||Rate difference|-22.4||||||95.0|-54.4|12.2||||||The seroconversion rates (the proportions of baseline seronegative subjects achieving a 4 or more fold increase in titer from baseline) were summarized for baseline seronegative subjects by treatment group and by dose number. A two-sided exact 95% confidence interval (CI) was constructed on the rate differences using the unconditional exact method proposed by Chan and Zhang (Chan, 1999).||12.2|-54.4|
72473470|NCT00461981|144470914|SUPERIORITY_OR_OTHER_LEGACY||Rate difference|33.3||||||95.0|-81.1|90.6||||||The seroconversion rates (the proportions of baseline seronegative subjects achieving a 4 or more fold increase in titer from baseline) were summarized for baseline seronegative subjects by treatment group and by dose number. A two-sided exact 95% confidence interval (CI) was constructed on the rate differences using the unconditional exact method proposed by Chan and Zhang (Chan, 1999).||90.6|-81.1|
72473471|NCT00461981|144470915|SUPERIORITY_OR_OTHER_LEGACY||Rate difference|0.0||||||95.0|-97.5|84.2||||||The seroconversion rates (the proportions of baseline seronegative subjects achieving a 4 or more fold increase in titer from baseline) were summarized for baseline seronegative subjects by treatment group and by dose number. A two-sided exact 95% confidence interval (CI) was constructed on the rate differences using the unconditional exact method proposed by Chan and Zhang (Chan, 1999).||84.2|-97.5|
72473472|NCT00461981|144470916|SUPERIORITY_OR_OTHER_LEGACY||Rate difference|-9.5||||||95.0|-65.2|58.8||||||The seroconversion rates (the proportions of baseline seronegative subjects achieving a 4 or more fold increase in titer from baseline) were summarized for baseline seronegative subjects by treatment group and by dose number. A two-sided exact 95% confidence interval (CI) was constructed on the rate differences using the unconditional exact method proposed by Chan and Zhang (Chan, 1999).||58.8|-65.2|
72473473|NCT00461981|144470917|SUPERIORITY_OR_OTHER_LEGACY||Rate difference|-20.0||||||95.0|-71.6|33.9||||||The seroconversion rates (the proportions of baseline seronegative subjects achieving a 4 or more fold increase in titer from baseline) were summarized for baseline seronegative subjects by treatment group and by dose number. A two-sided exact 95% confidence interval (CI) was constructed on the rate differences using the unconditional exact method proposed by Chan and Zhang (Chan, 1999).||33.9|-71.6|
72473474|NCT00461981|144470918|SUPERIORITY_OR_OTHER_LEGACY||GMT Ratio|0.23||||||95.0|0.15|0.35||||||Corresponding two-sided 95% CIs based on 10,000 bootstrap data sets for the ratios of strain-specific GMTs (FluMist/TIV) were constructed by drawing replicates with replacement from each of the 2 cells (2 treatment groups) of observed data. The number of replicates drawn from each cell in this fashion was equal to the observed sample size within each cell. For each of the 10,000 bootstrap data sets, the overall GMT ratio was calculated.||0.35|0.15|
72473475|NCT00461981|144470919|SUPERIORITY_OR_OTHER_LEGACY||GMT Ratio|0.11||||||95.0|0.05|0.22||||||Corresponding two-sided 95% CIs based on 10,000 bootstrap data sets for the ratios of strain-specific GMTs (FluMist/TIV) were constructed by drawing replicates with replacement from each of the 2 cells (2 treatment groups) of observed data. The number of replicates drawn from each cell in this fashion was equal to the observed sample size within each cell. For each of the 10,000 bootstrap data sets, the overall GMT ratio was calculated.||0.22|0.05|
72473476|NCT00461981|144470920|SUPERIORITY_OR_OTHER_LEGACY||GMT Ratio|4.85||||||95.0|2.51|9.22||||||Corresponding two-sided 95% CIs based on 10,000 bootstrap data sets for the ratios of strain-specific GMTs (FluMist/TIV) were constructed by drawing replicates with replacement from each of the 2 cells (2 treatment groups) of observed data. The number of replicates drawn from each cell in this fashion was equal to the observed sample size within each cell. For each of the 10,000 bootstrap data sets, the overall GMT ratio was calculated.||9.22|2.51|
72473477|NCT00461981|144470921|SUPERIORITY_OR_OTHER_LEGACY||GMT Ratio|3.31||||||95.0|1.46|7.54||||||Corresponding two-sided 95% CIs based on 10,000 bootstrap data sets for the ratios of strain-specific GMTs (FluMist/TIV) were constructed by drawing replicates with replacement from each of the 2 cells (2 treatment groups) of observed data. The number of replicates drawn from each cell in this fashion was equal to the observed sample size within each cell. For each of the 10,000 bootstrap data sets, the overall GMT ratio was calculated.||7.54|1.46|
72507062|NCT02214186|144546161|SUPERIORITY_OR_OTHER||||||<|0.05|ONE_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|Mann-Whitney followed by Friedman test||||||<0.05
72507063|NCT02214186|144546162|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|Mann-Whitney followed by Friedman test||||||<0.05
72507064|NCT02214186|144546163|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|ANOVA for repeated measures||||||<0.05
72507065|NCT02214186|144546164|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|Mann-Whitney followed by Friedman test||||||<0.05
72507066|NCT02214186|144546165|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|ANOVA for repeated measures.||||||>0.05
72507067|NCT02214186|144546166|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|Mann-Whitney followed by Friedman test||||||<0.05
72507068|NCT02214186|144546167|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
72507069|NCT02214186|144546168|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|ANOVA for repeated measures.||||||<0.05
72507070|NCT02214186|144546169|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<0.05
72507071|NCT03078608|144546233|SUPERIORITY||F statistic|0.0||||1|TWO_SIDED||||||ANOVA|Repeated measures ANOVA||||||1.00
72398243|NCT01163279|144302636|SUPERIORITY_OR_OTHER|||||||0.03||||||Statistical analysis applies to post intervention performance category|Chi-squared|||||||0.03
72398244|NCT01163279|144302636|SUPERIORITY_OR_OTHER|||||||0.32||||||Statistical analysis applies to post intervention satisfaction category|Chi-squared|||||||0.32
72507072|NCT03078608|144546234|SUPERIORITY||F statistic|2.58||||0.11|TWO_SIDED||||||ANOVA|Repeated measures ANOVA||||||0.11
72507073|NCT03078608|144546235|SUPERIORITY||F statistic|0.07||||0.79|TWO_SIDED||||||ANOVA|Repeated measures ANOVA||||||0.79
72507074|NCT03078608|144546236|SUPERIORITY||F statistic|1.17||||0.29|TWO_SIDED||||||ANOVA|Repeated measures ANOVA||||||0.29
72507075|NCT03078608|144546237|SUPERIORITY||F statistic|0.18||||0.67|TWO_SIDED||||||ANOVA|Repeated measures ANOVA||||||0.67
72398245|NCT01163279|144302636|SUPERIORITY_OR_OTHER|||||||0.54||||||Statistical analysis applies to 3-month follow up performance category|Chi-squared|||||||0.54
72398246|NCT01163279|144302636|SUPERIORITY_OR_OTHER|||||||0.26||||||Statistical analysis applies to 3-month follow up satisfaction category|Chi-squared|||||||0.26
72398247|NCT01163279|144302637|SUPERIORITY_OR_OTHER||||||<|0.05||||||Statistical analysis applies to immediately post intervention and 3 months post intervention categories|ANOVA|||||||<0.05
72398248|NCT01163279|144302638|SUPERIORITY_OR_OTHER||||||>|0.05||||||Statistical analysis applies to immediately post intervention and 3 months post intervention categories|ANOVA|||||||>0.05
72398249|NCT01163279|144302639|SUPERIORITY_OR_OTHER||||||>|0.05||||||Statistical analysis applies to immediately post intervention and 3 months post intervention categories|ANOVA|||||||>0.05
72473478|NCT00461981|144470922|SUPERIORITY_OR_OTHER_LEGACY||GMT Ratio|1.35||||||95.0|0.58|3.04||||||Corresponding two-sided 95% CIs based on 10,000 bootstrap data sets for the ratios of strain-specific GMTs (FluMist/TIV) were constructed by drawing replicates with replacement from each of the 2 cells (2 treatment groups) of observed data. The number of replicates drawn from each cell in this fashion was equal to the observed sample size within each cell. For each of the 10,000 bootstrap data sets, the overall GMT ratio was calculated.||3.04|0.58|
72473479|NCT00461981|144470923|SUPERIORITY_OR_OTHER_LEGACY||GMT Ratio|0.44||||||95.0|0.16|1.07||||||Corresponding two-sided 95% CIs based on 10,000 bootstrap data sets for the ratios of strain-specific GMTs (FluMist/TIV) were constructed by drawing replicates with replacement from each of the 2 cells (2 treatment groups) of observed data. The number of replicates drawn from each cell in this fashion was equal to the observed sample size within each cell. For each of the 10,000 bootstrap data sets, the overall GMT ratio was calculated.||1.07|0.16|
72473480|NCT00461981|144470924|SUPERIORITY_OR_OTHER_LEGACY||GMT Ratio|2.46||||||95.0|1.26|5.06||||||Corresponding two-sided 95% CIs based on 10,000 bootstrap data sets for the ratios of strain-specific GMTs (FluMist/TIV) were constructed by drawing replicates with replacement from each of the 2 cells (2 treatment groups) of observed data. The number of replicates drawn from each cell in this fashion was equal to the observed sample size within each cell. For each of the 10,000 bootstrap data sets, the overall GMT ratio was calculated.||5.06|1.26|
72473481|NCT00461981|144470925|SUPERIORITY_OR_OTHER_LEGACY||GMT Ratio|0.89||||||95.0|0.7|1.0||||||Corresponding two-sided 95% CIs based on 10,000 bootstrap data sets for the ratios of strain-specific GMTs (FluMist/TIV) were constructed by drawing replicates with replacement from each of the 2 cells (2 treatment groups) of observed data. The number of replicates drawn from each cell in this fashion was equal to the observed sample size within each cell. For each of the 10,000 bootstrap data sets, the overall GMT ratio was calculated.||1.00|0.70|
72473482|NCT00461981|144470926|SUPERIORITY_OR_OTHER_LEGACY||GMT Ratio|0.51||||||95.0|0.23|1.22||||||Corresponding two-sided 95% CIs based on 10,000 bootstrap data sets for the ratios of strain-specific GMTs (FluMist/TIV) were constructed by drawing replicates with replacement from each of the 2 cells (2 treatment groups) of observed data. The number of replicates drawn from each cell in this fashion was equal to the observed sample size within each cell. For each of the 10,000 bootstrap data sets, the overall GMT ratio was calculated.||1.22|0.23|
72507076|NCT03078608|144546238|SUPERIORITY||F statistic|1.41||||0.24|TWO_SIDED||||||ANOVA|Repeated measures ANOVA||||||0.24
72507077|NCT03078608|144546239|SUPERIORITY||F statistic|1.36||||0.25|TWO_SIDED||||||ANOVA|Repeated measures ANOVA||||||0.25
72398250|NCT01163279|144302640|SUPERIORITY_OR_OTHER||||||<|0.05||||||Statistical analysis applies to immediately post intervention and 3 months post intervention categories|ANOVA|||||||<0.05
72398251|NCT01163279|144302641|SUPERIORITY_OR_OTHER||||||<|0.1||||||Statistical analysis applies to immediately post intervention category|ANOVA|||||||<0.1
72398252|NCT01163279|144302641|SUPERIORITY_OR_OTHER||||||<|0.05||||||Statistical analysis applies to 3 months post intervention category|ANOVA|||||||<0.05
72398253|NCT01163279|144302642|SUPERIORITY_OR_OTHER||||||<|0.05||||||Statistical analysis applies to immediately post intervention category|ANOVA|||||||<0.05
72398254|NCT01163279|144302642|SUPERIORITY_OR_OTHER||||||>|0.05||||||Statistical analysis applies to 3 months post intervention category|ANOVA|||||||>0.05
72398255|NCT01163279|144302643|SUPERIORITY_OR_OTHER||||||<|0.1||||||Statistical analysis applies to immediately post intervention category|ANOVA|||||||<0.1
72398256|NCT01163279|144302643|SUPERIORITY_OR_OTHER||||||<|0.05||||||Statistical analysis applies to 3 months post intervention category|ANOVA|||||||<0.05
72398257|NCT01163279|144302644|SUPERIORITY_OR_OTHER||||||<|0.05||||||Statistical analysis applies to immediately post intervention and 3 months post intervention categories|ANOVA|||||||<0.05
72398258|NCT01163279|144302645|SUPERIORITY_OR_OTHER||||||>|0.05||||||Statistical analysis applies to immediately post intervention category|ANOVA|||||||>0.05
72398259|NCT01163279|144302645|SUPERIORITY_OR_OTHER||||||<|0.05||||||Statistical analysis applies to 3 months post intervention category|ANOVA|||||||<0.05
72398260|NCT01163279|144302646|SUPERIORITY_OR_OTHER||||||>|0.05||||||Statistical analysis applies to immediately post intervention and 3 months post intervention categories|ANOVA|||||||>0.05
72398261|NCT00665353|144302665|SUPERIORITY_OR_OTHER||proportion|0.158||||0.29|ONE_SIDED|90.0|0.059|||This is an unadjusted p-value. Statistical significance was defined a priori as 0.10.|Exact test of proportions|||The proportion of subjects responding was compared to a historical null rate of 0.10. The hypothesized response rate was 0.30.|||0.059|0.29
72398262|NCT00665353|144302668|SUPERIORITY_OR_OTHER||proportion|0.053||||0.42|ONE_SIDED|90.0|0.001|||This is an unadjusted p-value. Statistical significance was defined a priori as 0.10.|Exact test of proportions|||The proportion of subjects responding was compared to a historical null rate of 0.02. The hypothesized response rate was 0.15.|||0.001|0.42
72398263|NCT02632552|144302707|EQUIVALENCE|Using a pre-intervention rate of 18 for both intervention and control, and a post-control change of 1, assuming an alpha of 0.05, we have power (0.8) to detect a difference of differences in change in mean urgent care/ED utilization of 0.75 with a standard deviation equal to the control mean; however, the equivalence boundary did not apply because this is a pragmatic trial.|Incidence Rate Ratio|1.11|STANDARD_ERROR_OF_MEAN|0.15||0.45|TWO_SIDED|95.0|0.85|1.45|||Mixed Effects Negative Binomial Model|A segmented negative binomial regression model was used to estimate changes in ED/urgent care utilization between the intervention and control groups.||||1.45|0.85|0.45
72398264|NCT02632552|144302708|EQUIVALENCE|We initially powered at 80% to detect an effect size of 0.5 for all secondary outcomes; however, the equivalence boundary did not apply because this is a pragmatic trial.|Beta for the Mean Difference|-1.8||||0.05|TWO_SIDED|95.0|-7.21|3.61|||Mixed Models Analysis|||||3.61|-7.21|0.05
72398265|NCT02632552|144302709|EQUIVALENCE|We initially powered at 80% to detect an effect size of 0.5 for all secondary outcomes; however, the equivalence boundary did not apply because this is a pragmatic trial.|Beta for the Mean Difference|0.82|STANDARD_ERROR_OF_MEAN|0.38||0.03|TWO_SIDED|95.0|0.08|1.57|||Mixed Models Analysis|MMA by group, time, and group by time as predictors. We also adjusted by: Marital Status and indicator variable for problems learning online.||||1.57|0.08|0.03
72398266|NCT02632552|144302710|EQUIVALENCE|We initially powered at 80% to detect an effect size of 0.5 for all secondary outcomes; however, the equivalence boundary did not apply because this is a pragmatic trial.|Beta for Mean Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.18||0.75|TWO_SIDED|95.0|-0.41|0.29|||Mixed Models Analysis|MMA by group, time, and group by time as predictors. We also adjusted by: Marital Status and indicator variable for problems learning online.||||0.29|-0.41|0.75
72507078|NCT03078608|144546240|SUPERIORITY||F statistic|0.53||||0.47|TWO_SIDED||||||ANOVA|Repeated measures ANOVA||||||0.47
72565855|NCT02709486|144662724|SUPERIORITY||Odds Ratio (OR)|0.84||||0.3238|TWO_SIDED|95.0|0.6|1.18|||Regression, Logistic|||Week 24: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||1.18|0.60|0.3238
72623075|NCT04003389|144776428|SUPERIORITY||LSMean difference|0.028|STANDARD_ERROR_OF_MEAN|0.029||0.328|TWO_SIDED|95.0|-0.028|0.084||The LSM, SE, CI, and p-values come from an ANCOVA model with change from baseline at the Week 52 timepoint as response, treatment and smoking status (current vs former/never) as fixed effects with baseline weight and baseline as covariates.|ANCOVA|||Hip (Trochanter)||0.084|-0.028|0.328
72507079|NCT03078608|144546241|SUPERIORITY||F statistic|1.54||||0.23|TWO_SIDED||||||ANOVA|Repeated measures ANOVA||||||0.23
72507080|NCT03078608|144546242|SUPERIORITY||F statistic|0.8||||0.39|TWO_SIDED||||||ANOVA|Repeated measures ANOVA||||||0.39
72507081|NCT02086565|144546258|SUPERIORITY||Group differences in expected 12 month c|-0.21|||||TWO_SIDED|95.0|-0.56|0.15||||||||0.15|-0.56|
72507082|NCT02086565|144546259|SUPERIORITY||Group differences in expected 12 month c|0.19|||||TWO_SIDED|95.0|-0.27|0.68|||||Estimation parameter: Other. Group differences in expected 12 month change from baseline|||0.68|-0.27|
72507083|NCT02086565|144546260|SUPERIORITY||Group differences in expected 12 month c|-0.6|||||TWO_SIDED|95.0|-2.21|0.97||||||||0.97|-2.21|
72507084|NCT02086565|144546261|SUPERIORITY||Group differences in expected 12 month c|-0.53|||||TWO_SIDED|95.0|-1.08|-0.24||||||||-0.24|-1.08|
72507085|NCT02086565|144546262|SUPERIORITY||Group differences in expected 12 month c|-0.09|||||TWO_SIDED|95.0|-0.24|0.06||||||||0.06|-0.24|
72507086|NCT02116972|144546270|SUPERIORITY||Mean Difference (Final Values)|-0.58||||0.0821|TWO_SIDED|95.0|-1.22|0.07|||Logitudinal mixed effects model|||The step-down testing procedure to control for multiplicity would be voided if the primary endpoint is not met and analyses proceeded for exploratory purposes.||0.07|-1.22|0.0821
72507087|NCT00784784|144546284|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.23||||0.25|TWO_SIDED|95.0|0.01|4.8|||Fisher Exact|||That in a year with mismatch between influenza vaccine antigen and infecting H3N2 strain, seasonal (10-13 weeks) antiviral prophylaxis in adults will provide better protection from symptomatic influenza infection than trivalent inactivated split virus influenza vaccine.||4.8|0.01|0.25
72565856|NCT02709486|144662726|SUPERIORITY||LS Mean Ratio|0.67|STANDARD_ERROR_OF_MEAN|0.07||0.0001|TWO_SIDED|95.0|0.54|0.82|||Negative binomial model|||Week 2: Least square (LS) Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.||0.82|0.54|0.0001
72623076|NCT04003389|144776429|SUPERIORITY||LSMean difference|0.002|STANDARD_ERROR_OF_MEAN|0.004||0.497||95.0|-0.005|0.009||The LSM, SE, CI, and p-values come from an ANCOVA model with change from baseline at the Week 52 timepoint as response, treatment and smoking status (current vs former/never) as fixed effects with baseline weight and baseline as covariates.|ANCOVA|||||0.009|-0.005|0.497
72398267|NCT02632552|144302711|EQUIVALENCE|We initially powered at 80% to detect an effect size of 0.5 for all secondary outcomes; however, the equivalence boundary did not apply because this is a pragmatic trial.|Beta for Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.3||0.74|TWO_SIDED|95.0|-0.5|0.7|||Mixed Models Analysis|MMA by group, time, and group by time as predictors. We also adjusted by: Marital Status and indicator variable for problems learning online.||||0.70|-0.50|0.74
72507088|NCT01400971|144546285|OTHER|Multivariable logistic regression model examined baseline participant-, physician-, and healthcare system-related factors associated with the occurrence of any change in insulin therapy.|Odds Ratio (OR)|0.7|||||TWO_SIDED|95.0|0.54|0.92||||||Public insurance||0.92|0.54|
72507089|NCT01400971|144546285|OTHER|Multivariable logistic regression model examined baseline participant-, physician-, and healthcare system-related factors associated with the occurrence of any change in insulin therapy.|Odds Ratio (OR)|1.92|||||TWO_SIDED|95.0|1.5|2.46||||||Diabetes support service available||2.46|1.50|
72507090|NCT01400971|144546285|OTHER|Multivariable logistic regression model examined baseline participant-, physician-, and healthcare system-related factors associated with the occurrence of any change in insulin therapy.|Odds Ratio (OR)|1.85|||||TWO_SIDED|95.0|1.38|2.49||||||Baseline HbA1c \> 7.80 (reference:HbA1c≤7.80 median)||2.49|1.38|
72507091|NCT01400971|144546285|OTHER|Multivariable logistic regression model examined baseline participant-, physician-, and healthcare system-related factors associated with the occurrence of any change in insulin therapy.|Odds Ratio (OR)|1.54|||||TWO_SIDED|95.0|1.15|2.07||||||Baseline HbA1c missing (reference:HbA1c≤7.80 median)||2.07|1.15|
72507092|NCT01400971|144546285|OTHER|Multivariable logistic regression model examined baseline participant-, physician-, and healthcare system-related factors associated with the occurrence of any change in insulin therapy.|Odds Ratio (OR)|1.46|||||TWO_SIDED|95.0|1.13|1.88||||||Diabetes duration \> 11 years||1.88|1.13|
72507093|NCT01400971|144546285|OTHER|Multivariable logistic regression model examined baseline participant-, physician-, and healthcare system-related factors associated with the occurrence of any change in insulin therapy.|Odds Ratio (OR)|0.98|||||TWO_SIDED|95.0|0.97|1.0||||||Age (per year increase)||1.00|0.97|
72507094|NCT01400971|144546285|OTHER|Multivariable logistic regression model examined baseline participant-, physician-, and healthcare system-related factors associated with the occurrence of any change in insulin therapy.|Odds Ratio (OR)|10.5|||||TWO_SIDED|95.0|3.3|33.41||||||Baseline insulin therapy: combination||33.41|3.30|
72623077|NCT04003389|144776429|SUPERIORITY||LSMean difference|-0.001|STANDARD_ERROR_OF_MEAN|0.004||0.878||95.0|-0.007|0.006||The LSM, SE, CI, and p-values come from an ANCOVA model with change from baseline at the Week 52 timepoint as response, treatment and smoking status (current vs former/never) as fixed effects with baseline weight and baseline as covariates.|ANCOVA|||||0.006|-0.007|0.878
72623078|NCT04003389|144776430|SUPERIORITY||LSMean difference|0.02|STANDARD_ERROR_OF_MEAN|0.031||0.527|TWO_SIDED|95.0|-0.042|0.082||The LSM, SE, CI, and p-values come from an ANCOVA model with change from baseline at the Week 52 timepoint as response, treatment and smoking status (current vs former/never) as fixed effects with baseline weight and baseline as covariates.|ANCOVA|||||0.082|-0.042|0.527
72623079|NCT04003389|144776430|SUPERIORITY||LSMean difference|-0.005|STANDARD_ERROR_OF_MEAN|0.031||0.872||95.0|-0.066|0.056||The LSM, SE, CI, and p-values come from an ANCOVA model with change from baseline at the Week 52 timepoint as response, treatment and smoking status (current vs former/never) as fixed effects with baseline weight and baseline as covariates.|ANCOVA|||||0.056|-0.066|0.872
72473483|NCT00461981|144470927|SUPERIORITY_OR_OTHER_LEGACY||GMT Ratio|4.0||||||95.0|4.0|4.0||||||Corresponding two-sided 95% CIs based on 10,000 bootstrap data sets for the ratios of strain-specific GMTs (FluMist/TIV) were constructed by drawing replicates with replacement from each of the 2 cells (2 treatment groups) of observed data. The number of replicates drawn from each cell in this fashion was equal to the observed sample size within each cell. For each of the 10,000 bootstrap data sets, the overall GMT ratio was calculated.||4.00|4.00|
72473484|NCT00461981|144470928|SUPERIORITY_OR_OTHER_LEGACY||GMT Ratio|0.8||||||95.0|0.22|3.63||||||Corresponding two-sided 95% CIs based on 10,000 bootstrap data sets for the ratios of strain-specific GMTs (FluMist/TIV) were constructed by drawing replicates with replacement from each of the 2 cells (2 treatment groups) of observed data. The number of replicates drawn from each cell in this fashion was equal to the observed sample size within each cell. For each of the 10,000 bootstrap data sets, the overall GMT ratio was calculated.||3.63|0.22|
72473485|NCT00461981|144470929|SUPERIORITY_OR_OTHER_LEGACY||GMT Ratio|0.66||||||95.0|0.25|1.73||||||Corresponding two-sided 95% CIs based on 10,000 bootstrap data sets for the ratios of strain-specific GMTs (FluMist/TIV) were constructed by drawing replicates with replacement from each of the 2 cells (2 treatment groups) of observed data. The number of replicates drawn from each cell in this fashion was equal to the observed sample size within each cell. For each of the 10,000 bootstrap data sets, the overall GMT ratio was calculated.||1.73|0.25|
72473486|NCT00461981|144470934|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Equivalence|||||<|0.001||95.0|||||Wilcoxon (Mann-Whitney)|||||||< 0.001
72473487|NCT00731133|144470975|SUPERIORITY_OR_OTHER||Slope|2.6466|STANDARD_ERROR_OF_MEAN|0.9016||0.05|TWO_SIDED|95.0|0.7858|4.5073|||Mixed Models Analysis|7,24||Open-label study testing for change in side-effects ratings over time (i.e., slope).||4.5073|.7858|0.05
72473488|NCT00731133|144470976|SUPERIORITY_OR_OTHER||Slope|-0.373|STANDARD_ERROR_OF_MEAN|0.2196||0.05|TWO_SIDED|95.0|-0.8075|0.0615|||Mixed Models Analysis|7,24||Open label study testing changes in amphetamine use over time (i.e., slope).||0.06150|-0.8075|0.05
72473489|NCT03098563|144470998|SUPERIORITY|||||||0.021|||||||ANOVA|||||||.021
72473490|NCT02964325|144471012|NON_INFERIORITY|An NI analysis was carried out to assess the primary efficacy endpoint with the null hypothesis being the MIRASOL group is inferior to the CONTROL group and the alternative hypothesis being the MIRASOL group is non-inferior to the CONTROL group. In this study, the NI margin was 1.6.|Relative Rate|2.79|||||TWO_SIDED|95.0|1.67|4.67|||||The MIRASOL group represents the numerator and the CONTROL group represents the denominator for the relative rate. For days during off-protocol intervals, bleeding data were simulated using an estimate of the individual-specific bleeding rate.|The MIRASOL and CONTROL groups were compared with respect to the number of days of WHO ≥ Grade 2 bleeding. This was carried out by fitting a negative binomial regression model with an offset defined as the natural logarithm (LN) of the number of days that bleeding was assessed in order to account for the fact that subjects had different numbers of bleeding assessment days.||4.67|1.67|
72473491|NCT02964325|144471014|NON_INFERIORITY|A non-inferiority margin of 1.2 was used to evaluated this endpoint.|Relative Risk|1.32||||0.7274|TWO_SIDED|95.0|0.97|1.81|||Wald Non-inferiority Test||The MIRASOL group represents the numerator and the CONTROL group represents the denominator for the relative risk.|The null hypothesis was H0: pt/pc \> 1.2 (ie, MIRASOL had more than a 20% higher probability of a patient experiencing at least one WHO ≥ Grade 2 bleed compared to CONTROL).||1.81|0.97|0.7274
72473492|NCT02964325|144471015|OTHER|||||||0.07|||||||Log-rank test|||||||0.07
72473493|NCT02964325|144471016|OTHER|||||||0.1649|||||||Fisher Exact|||||||0.1649
72473494|NCT02964325|144471017|OTHER||Risk Ratio (RR)|2.15||||0.0015|TWO_SIDED|95.0|1.32|3.49|||Fisher Exact|||||3.49|1.32|0.0015
72473495|NCT04145700|144471076|SUPERIORITY||Posterior Mean Hazard Ratio|2.62||||0.051|TWO_SIDED|80.0|1.19|4.46|||Bayesian hierarchical model|||To conclude success for the intervention, the Bayesian analysis must yield a minimum of 99% posterior probability for PFS Hazard ratio less than 1 \[i.e., Pr(HR \< 1) \> 99%\]. The Bayesian analyses below include posterior mean of Hazard ratio, posterior probabilities instead of p-values, and credible intervals instead of confidence intervals.||4.46|1.19|0.051
72473496|NCT04978493|144471088|OTHER||Difference of adjusted means|1.92|STANDARD_ERROR_OF_MEAN|1.45|||TWO_SIDED|95.0|-0.99|4.84|||||(Adjusted mean BI 706321 and ustekinumab) - (adjusted mean Placebo and ustekinumab)|The analysis was a restricted maximum likelihood (REML) based analysis of covariance (ANCOVA). For the ANCOVA model, absolute change in SES-CD score was the dependent variable, treatment group and baseline corticosteroid use (yes/no) were fixed effects and baseline SES-CD score was a continuous covariate.||4.84|-0.99|
72507095|NCT01400971|144546285|OTHER|Multivariable logistic regression model examined baseline participant-, physician-, and healthcare system-related factors associated with the occurrence of any change in insulin therapy.|Odds Ratio (OR)|5.71|||||TWO_SIDED|95.0|1.77|18.37||||||Baseline insulin therapy: prandial only||18.37|1.77|
72507096|NCT01400971|144546285|OTHER|Multivariable logistic regression model examined baseline participant-, physician-, and healthcare system-related factors associated with the occurrence of any change in insulin therapy.|Odds Ratio (OR)|4.16|||||TWO_SIDED|95.0|3.02|5.73||||||Baseline insulin therapy: pre-mixed only||5.73|3.02|
72507097|NCT01400971|144546285|OTHER|Multivariable logistic regression model examined baseline participant-, physician-, and healthcare system-related factors associated with the occurrence of any change in insulin therapy. IPC ranges from 1-5 with higher scores indicating more discrimination.|Odds Ratio (OR)|0.5|||||TWO_SIDED|95.0|0.39|0.65||||||Discrimination domain of the IPC||0.65|0.39|
72473497|NCT04978493|144471089|OTHER||Difference of adjusted means|13.34|STANDARD_ERROR_OF_MEAN|11.32|||TWO_SIDED|95.0|-9.46|36.14|||||(Adjusted mean BI 706321 and ustekinumab) - (adjusted mean Placebo and ustekinumab)|The analysis was a restricted maximum likelihood (REML) based analysis of covariance (ANCOVA). For the ANCOVA model, absolute change in SES-CD score was the dependent variable, treatment group and baseline corticosteroid use (yes/no) were fixed effects and baseline SES-CD score was a continuous covariate.||36.14|-9.46|
72565857|NCT02709486|144662726|SUPERIORITY||LS Mean Ratio|0.75|STANDARD_ERROR_OF_MEAN|0.08||0.0067|TWO_SIDED|95.0|0.61|0.92|||Negative binomial model|||Week 2: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.||0.92|0.61|0.0067
72473498|NCT04978493|144471090|OTHER||Unadjusted risk difference|-27.5|||||TWO_SIDED|95.0|-48.42|-2.64|||||BI 706321 and ustekinumab - Placebo and ustekinumab|Unadjusted risk difference between treatment groups were calculated simply as the difference in the observed percentage of patients. The method to provide confidence intervals for the unadjusted risk differences was derived from the Newcombe method.||-2.64|-48.42|
72473499|NCT04978493|144471091|OTHER||Unadjusted risk difference|0.67|||||TWO_SIDED|95.0|-20.49|22.12|||||BI 706321 and ustekinumab - Placebo and ustekinumab|Unadjusted risk difference between treatment groups were calculated simply as the difference in the observed percentage of patients. The method to provide confidence intervals for the unadjusted risk differences was derived from the Newcombe method.||22.12|-20.49|
72473500|NCT04978493|144471092|OTHER||Unadjusted risk difference|-3.83|||||TWO_SIDED|95.0|-21.14|13.25|||||BI 706321 and ustekinumab - Placebo and ustekinumab|Unadjusted risk difference between treatment groups were calculated simply as the difference in the observed percentage of patients. The method to provide confidence intervals for the unadjusted risk differences was derived from the Newcombe method.||13.25|-21.14|
72473501|NCT04978493|144471093|OTHER||Unadjusted risk difference|0.33|||||TWO_SIDED|95.0|-17.67|18.78|||||BI 706321 and ustekinumab - Placebo and ustekinumab|Unadjusted risk difference between treatment groups were calculated simply as the difference in the observed percentage of patients. The method to provide confidence intervals for the unadjusted risk differences was derived from the Newcombe method.||18.78|-17.67|
72473502|NCT04978493|144471094|OTHER||Unadjusted risk difference|-3.33|||||TWO_SIDED|95.0|-24.91|18.85|||||BI 706321 and ustekinumab - Placebo and ustekinumab|Unadjusted risk difference between treatment groups were calculated simply as the difference in the observed percentage of patients. The method to provide confidence intervals for the unadjusted risk differences was derived from the Newcombe method.||18.85|-24.91|
72473503|NCT04978493|144471095|OTHER||Unadjusted risk difference|-3.5|||||TWO_SIDED|95.0|-23.86|17.34|||||BI 706321 and ustekinumab - Placebo and ustekinumab|Unadjusted risk difference between treatment groups were calculated simply as the difference in the observed percentage of patients. The method to provide confidence intervals for the unadjusted risk differences was derived from the Newcombe method.||17.34|-23.86|
72473504|NCT04978493|144471096|OTHER||Unadjusted risk difference|-18.5|||||TWO_SIDED|95.0|-42.32|8.89|||||BI 706321 and ustekinumab - Placebo and ustekinumab|Unadjusted risk difference between treatment groups were calculated simply as the difference in the observed percentage of patients. The method to provide confidence intervals for the unadjusted risk differences was derived from the Newcombe method.||8.89|-42.32|
72473505|NCT04978493|144471097|OTHER||Unadjusted risk difference|0.83|||||TWO_SIDED|95.0|-21.53|23.41|||||BI 706321 and ustekinumab - Placebo and ustekinumab|Unadjusted risk difference between treatment groups were calculated simply as the difference in the observed percentage of patients. The method to provide confidence intervals for the unadjusted risk differences was derived from the Newcombe method.||23.41|-21.53|
72473506|NCT04978493|144471098|OTHER||Unadjusted risk difference|-22.17|||||TWO_SIDED|95.0|-45.42|5.19|||||BI 706321 and ustekinumab - Placebo and ustekinumab|Unadjusted risk difference between treatment groups were calculated simply as the difference in the observed percentage of patients. The method to provide confidence intervals for the unadjusted risk differences was derived from the Newcombe method.||5.19|-45.42|
72473507|NCT04608773|144471115|SUPERIORITY||||||<|0.501|||||||ANCOVA|||Null hypothesis is that there was no difference in change of Dry mouth score between Refresh and Biotene. ANCOVA model was performed by regressing the difference in after-treatment measurement between Refresh and Biotene over the difference of baseline between Refresh and Biotene. The test was performed with a significance level of 0.05 (two- sided)||||<0.501
72473508|NCT04608773|144471116|SUPERIORITY|||||||0.109|||||||ANCOVA|||||||.109
72473509|NCT04608773|144471117|SUPERIORITY|||||||0.107|||||||ANCOVA|||||||.107
72473510|NCT04608773|144471118|SUPERIORITY|||||||0.489|||||||ANCOVA|||||||.489
72473511|NCT04608773|144471119|SUPERIORITY|||||||0.213|||||||ANCOVA|||||||.213
72473512|NCT04608773|144471120|SUPERIORITY|||||||0.486|||||||ANCOVA|||||||.486
72473513|NCT02387970|144471122|SUPERIORITY|||||||0.088|||||||t-test, 2 sided|||||||0.088
72473514|NCT02387970|144471123|SUPERIORITY|||||||0.235|||||||t-test, 2 sided|||||||0.235
72565858|NCT02709486|144662726|SUPERIORITY||LS Mean Ratio|0.64|STANDARD_ERROR_OF_MEAN|0.08||0.0003|TWO_SIDED|95.0|0.51|0.82|||Negative binomial model|||Week 4: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.||0.82|0.51|0.0003
72473515|NCT02387970|144471124|SUPERIORITY|||||||0.165|||||||t-test, 2 sided|||||||0.165
72473516|NCT02387970|144471125|SUPERIORITY|||||||0.297|||||||t-test, 2 sided|||||||0.297
72473517|NCT02387970|144471126|SUPERIORITY|||||||0.121|||||||t-test, 2 sided|||||||0.121
72473518|NCT02387970|144471127|SUPERIORITY|||||||0.248|||||||t-test, 2 sided|||||||0.248
72473519|NCT02387970|144471128|SUPERIORITY|||||||0.854|||||||t-test, 2 sided|||||||0.854
72473520|NCT04662060|144471129|OTHER||Hazard Ratio (HR)|0.6||||0.07|TWO_SIDED|95.0|0.34|1.04||A p-value of \<0.05 would be considered statistically significant.|Cox proportional hazards model|Two-sided Cox proportional hazards model adjusted for age, sex, and receipt of baseline receipt of monoclonal antibodies.||A two-sided log rank test at the 0.04999 level of significance for the final analysis required 78 events (i.e., sustained symptom resolution) to provide 80% power to detect a hazard ratio of 1.91. Based on previous outpatient COVID-19 trials at Stanford, assumed placebo and treatment arm median time to symptom resolution of 10 and 5 days, respectively, for a total sample size of 120 patients. Participants with missing data lasting through Day 28 were censored on Day 28.||1.04|0.34|0.07
72473521|NCT04662060|144471130|OTHER|||||||0.2||||||A p-value of \<0.05 would be considered statistically significant.|Linear mixed-effects regression model|||A generalized linear mixed effects model with parameterization was utilized to capture the difference in change in viral shedding at day 10 between treatment arms. SARS-CoV2 viral RNA CT values were transformed using a standard Reference curve.||||0.20
72473522|NCT04662060|144471132|OTHER||Hazard Ratio (HR)|0.62||||0.05|TWO_SIDED|95.0|0.38|1.01|||Linear mixed-effects regression model|||||1.01|0.38|0.05
72473523|NCT04662060|144471133|OTHER||Hazard Ratio (HR)|0.59|||||TWO_SIDED|95.0|0.34|1.01||||||||1.01|0.34|
72473524|NCT04662060|144471134|OTHER|||||||0.21||||||A p-value of \<0.05 would be considered statistically significant.|Fisher Exact|||Difference in incidence of ED visits||||0.21
72507098|NCT01400971|144546285|OTHER|Multivariable logistic regression model examined baseline participant-, physician-, and healthcare system-related factors associated with the occurrence of any change in insulin therapy. Diabetes Distress Scale ranges from 1-6 with higher scores indicating more distress.|Odds Ratio (OR)|0.74|||||TWO_SIDED|95.0|0.57|0.95||||||Diabetes Distress Scale total score \> 2||0.95|0.57|
72507099|NCT01905397|144546289|SUPERIORITY||Difference in proportions|0.05||||0.27|ONE_SIDED||||||t-test, 1 sided|||||||0.27
72507100|NCT00844428|144546292|SUPERIORITY_OR_OTHER||Percent of TMA event-free responders|80.0|||||TWO_SIDED|95.0|56.0|94.0||||||"With a total of 20 patients enrolled between both protocols and, assuming that the true expected probability of TMA Event-Free for eculizumab-treated patients is 40%, then the study had 93.5% power to detect a statistically significant difference. Up to approximately 30 patients were to be enrolled.~All analyses were based on the pooled data from the two protocols: C08-003A (adult) and C08-003B (adolescent), a similar protocol, for patients \<18 years with aHUS."||94|56|
72507101|NCT00844428|144546293|SUPERIORITY_OR_OTHER||Percent of hematologic normalization|90.0|||||TWO_SIDED|95.0|68.0|99.0||||||All analyses were based on the pooled data from the two protocols: C08-003A (adult) and C08-003B (adolescent), a similar protocol, for patients \<18 years with aHUS.||99|68|
72507102|NCT00844428|144546294|SUPERIORITY_OR_OTHER||Percent of complete TMA response|25.0|||||TWO_SIDED|95.0|9.0|49.0||||||All analyses were based on the pooled data from the two protocols: C08-003A (adult) and C08-003B (adolescent), a similar protocol, for patients \<18 years with aHUS.||49|9|
72473525|NCT00316017|144471137|SUPERIORITY_OR_OTHER|||||||0.91||95.0||||The Statistical Analysis applies to the 7.5% hypertonic saline/6% Dextran-70 (HSD),7.5% hypertonic saline (HS), and 0.9% normal saline groups.|test for proportions|||The null hypothesis is that there are no differences in the percent of patients who survived to day 28 day between the three groups.||||0.91
72473526|NCT00316017|144471138|SUPERIORITY_OR_OTHER|||||||0.94||95.0||||The Statistical Analysis applies to the 7.5% hypertonic saline/6% Dextran-70 (HSD),7.5% hypertonic saline (HS), and 0.9% normal saline groups.|test for proportions|||The null hypothesis is that there are no differences in ARDS-free survival through day 28 between the three groups.||||0.94
72473527|NCT00316017|144471139|SUPERIORITY_OR_OTHER|||||||0.73||95.0||||The Statistical Analysis applies to the 7.5% hypertonic saline/6% Dextran-70 (HSD),7.5% hypertonic saline (HS), and 0.9% normal saline groups.|ANOVA|||The null hypothesis is that there are no differences in average Worst Multiple Organ Dysfunction Scores (MODS) through day 28 between the three groups.||||0.73
72507103|NCT00844428|144546295|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.29|||<|0.0001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||All analyses were based on the pooled data from the two protocols: C08-003A (adult) and C08-003B (adolescent), a similar protocol, for patients \<18 years with aHUS.||||<0.0001
72507104|NCT00844428|144546296|SUPERIORITY_OR_OTHER||LS mean change from baseline|6.75||||0.5423|TWO_SIDED|95.0|-15.73|29.23|||ANOVA|Change from baseline were analyzed using a repeated measurement ANOVA model with time and baseline as fixed effects and subject as a random effect.||All analyses were based on the pooled data from the two protocols: C08-003A (adult) and C08-003B (adolescent), a similar protocol, for patients \<18 years||29.23|-15.73|0.5423
72507105|NCT00844428|144546297|SUPERIORITY_OR_OTHER||Percent of platelet count normalization|90.0|||||TWO_SIDED|95.0|68.0|99.0||||||All analyses were based on the pooled data from the two protocols: C08-003A (adult) and C08-003B (adolescent), a similar protocol, for patients \<18 years||99|68|
72507106|NCT00844428|144546298|SUPERIORITY_OR_OTHER||Percent of TMA event-free responders|95.0|||||TWO_SIDED|95.0|75.0|100.0||||||All analyses were based on the pooled data from the two protocols: C08-003A (adult) and C08-003B (adolescent), a similar protocol, for patients \<18 years with aHUS.||100|75|
72507107|NCT00844428|144546299|SUPERIORITY_OR_OTHER||Percent of hematologic normalization|90.0|||||TWO_SIDED|95.0|68.0|99.0||||||All analyses were based on the pooled data from the two protocols: C08-003A (adult) and C08-003B (adolescent), a similar protocol, for patients \<18 years with aHUS.||99|68|
72507108|NCT00844428|144546300|SUPERIORITY_OR_OTHER||Percent of complete TMA response|55.0|||||TWO_SIDED|95.0|32.0|77.0||||||All analyses were based on the pooled data from the two protocols: C08-003A (adult) and C08-003B (adolescent), a similar protocol, for patients \<18 years with aHUS.||77|32|
72507109|NCT00844428|144546301|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.29|||<|0.0001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||All analyses were based on the pooled data from the two protocols: C08-003A (adult) and C08-003B (adolescent), a similar protocol, for patients \<18 years with aHUS.||||<0.0001
72507110|NCT00844428|144546302|SUPERIORITY_OR_OTHER||LS mean change from baseline|-3.68||||0.7307|TWO_SIDED|95.0|-25.15|17.79|||ANOVA|Change from baseline were analyzed using a repeated measurement ANOVA model with time and baseline as fixed effects and subject as a random effect.||All analyses were based on the pooled data from the two protocols: C08-003A (adult) and C08-003B (adolescent), a similar protocol, for patients \<18 years with aHUS.||17.79|-25.15|0.7307
72507111|NCT00844428|144546303|SUPERIORITY_OR_OTHER||Percent of platelet count normalization|90.0|||||TWO_SIDED|95.0|68.0|99.0||||||All analyses were based on the pooled data from the two protocols: C08-003A (adult) and C08-003B (adolescent), a similar protocol, for patients \<18 years||99|68|
72507112|NCT02099799|144546310|SUPERIORITY||Mean Difference (Final Values)|-12.0||||0.189|TWO_SIDED||||||Mixed Models Analysis|||||||0.189
72507113|NCT02099799|144546311|SUPERIORITY||Mean Difference (Final Values)|2.1||||0.572|TWO_SIDED||||||Mixed Models Analysis|||||||0.572
72507114|NCT02099799|144546312|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.799|TWO_SIDED||||||Mixed Models Analysis|||||||0.799
72507115|NCT02099799|144546313|SUPERIORITY||Mean Difference (Final Values)|1312.0|||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
72398268|NCT02632552|144302712|EQUIVALENCE|We initially powered at 80% to detect an effect size of 0.5 for all secondary outcomes; however, the equivalence boundary did not apply because this is a pragmatic trial.|Beta for mean difference|-0.41|STANDARD_ERROR_OF_MEAN|0.87||0.63|TWO_SIDED|95.0|-2.21|1.29|||Mixed Models Analysis|MMA by group, time, and group by time as predictors. We also adjusted by: Marital Status and indicator variable for problems learning online.||||1.29|-2.21|0.63
72398269|NCT02632552|144302713|EQUIVALENCE|We initially powered at 80% to detect an effect size of 0.5 for all secondary outcomes; however, the equivalence boundary did not apply because this is a pragmatic trial.|Beta of Mean Difference|1.54|STANDARD_ERROR_OF_MEAN|1.26||0.23|TWO_SIDED|95.0|-0.97|4.05|||Mixed Models Analysis|MMA by group, time, and group by time as predictors. We also adjusted by: Marital Status and indicator variable for problems learning online.||||4.05|-0.97|0.23
72507116|NCT02099799|144546314|SUPERIORITY|||||||0.2265|||||||t-test, 2 sided|||||||0.2265
72507117|NCT02099799|144546315|SUPERIORITY|||||||0.8897|||||||t-test, 2 sided|||||||0.8897
72398270|NCT02632552|144302714|EQUIVALENCE|We initially powered at 80% to detect an effect size of 0.5 for all secondary outcomes; however, the equivalence boundary did not apply because this is a pragmatic trial.|Beta for the Mean Difference|-2.43|STANDARD_ERROR_OF_MEAN|2.8||0.38|TWO_SIDED|95.0|-7.95|3.1||MMA by group, time, and group by time as predictors. We also adjusted by: Marital Status and indicator variable for problems learning online.|Mixed Models Analysis|||||3.10|-7.95|0.38
72398271|NCT02632552|144302715|EQUIVALENCE|We initially powered at 80% to detect an effect size of 0.5 for all secondary outcomes; however, the equivalence boundary did not apply because this is a pragmatic trial.|Beta for the Mean Difference|-2.79|STANDARD_ERROR_OF_MEAN|3.2||0.38|TWO_SIDED|95.0|-9.1|3.52|||Mixed Models Analysis|MMA by group, time, and group by time as predictors. We also adjusted by: Marital Status and indicator variable for problems learning online.||||3.52|-9.10|0.38
72473528|NCT00316017|144471140|SUPERIORITY_OR_OTHER|||||||0.8||95.0||||The Statistical Analysis applies to the 7.5% hypertonic saline/6% Dextran-70 (HSD),7.5% hypertonic saline (HS), and 0.9% normal saline groups.|test for proportions|||The null hypothesis is that there are no differences in the percent of patients with the Presence of Nosocomial Infection through day 28 between the three groups.||||0.8
72473529|NCT00316017|144471141|SUPERIORITY_OR_OTHER|||||||0.69||95.0||||The Statistical Analysis applies to the 7.5% hypertonic saline/6% Dextran-70 (HSD),7.5% hypertonic saline (HS), and 0.9% normal saline groups.|ANOVA|||The null hypothesis is that there are no differences in the average number of PRBC units given within the first 24 hours between the three groups.||||0.69
72473530|NCT00316017|144471142|SUPERIORITY_OR_OTHER|||||||0.57||95.0||||The Statistical Analysis applies to the 7.5% hypertonic saline/6% Dextran-70 (HSD),7.5% hypertonic saline (HS), and 0.9% normal saline groups.|ANOVA|||The null hypothesis is that there are no differences in the average amount of Total fluids given within the first 24 hours between the three groups.||||0.57
72473531|NCT00316017|144471143|SUPERIORITY_OR_OTHER|||||||0.66||95.0||||The Statistical Analysis applies to the 7.5% hypertonic saline/6% Dextran-70 (HSD),7.5% hypertonic saline (HS), and 0.9% normal saline groups.|ANOVA|||The null hypothesis is that there are no differences in the average number of Ventilator-free days through day 28 between the three groups.||||0.66
72473532|NCT00316017|144471144|SUPERIORITY_OR_OTHER|||||||0.82||95.0||||The Statistical Analysis applies to the 7.5% hypertonic saline/6% Dextran-70 (HSD),7.5% hypertonic saline (HS), and 0.9% normal saline groups.|ANOVA|||The null hypothesis is that there are no differences in the average number of Days alive out of the ICU through day 28 between the three groups.||||0.82
72473533|NCT00316017|144471145|SUPERIORITY_OR_OTHER|||||||0.98||95.0||||The Statistical Analysis applies to the 7.5% hypertonic saline/6% Dextran-70 (HSD),7.5% hypertonic saline (HS), and 0.9% normal saline groups.|ANOVA|||The null hypothesis is that there are no differences in the average number of Days alive out of the hospital through day 28 between the three groups.||||0.98
72473534|NCT00316017|144471146|SUPERIORITY_OR_OTHER|||||||0.85||95.0||||The Statistical Analysis applies to the 7.5% hypertonic saline/6% Dextran-70 (HSD),7.5% hypertonic saline (HS), and 0.9% normal saline groups.|test for proportions|||The null hypothesis is that there are no differences in the percent of patients who survived to hospital discharge between the three groups.||||0.85
72473535|NCT00316017|144471147|SUPERIORITY_OR_OTHER|||||||0.48||95.0||||The Statistical Analysis applies to the 7.5% hypertonic saline/6% Dextran-70 (HSD),7.5% hypertonic saline (HS), and 0.9% normal saline groups.|test for proportions|||The null hypothesis is that there are no differences in the percent of patients who received zero units of PRBC in the first 24 hours between the three groups.||||0.48
72473536|NCT00316017|144471148|SUPERIORITY_OR_OTHER||||||<|0.01||95.0||||The Statistical Analysis applies to the 7.5% hypertonic saline/6% Dextran-70 (HSD),7.5% hypertonic saline (HS), and 0.9% normal saline groups.|test for proportions|||The null hypothesis is that there are no differences in the percent of patients who died in field or ED between the three groups among the patients who received zero units of PRBC.||||<0.01
72473537|NCT00316017|144471149|SUPERIORITY_OR_OTHER||||||<|0.02||95.0||||The Statistical Analysis applies to the 7.5% hypertonic saline/6% Dextran-70 (HSD),7.5% hypertonic saline (HS), and 0.9% normal saline groups.|test for proportions|||The null hypothesis is that there are no differences in percent of patients who died within 6 hours of admission to the hospital between the three groups among patients who received zero units of PRBC.||||<0.02
72473538|NCT00316017|144471150|SUPERIORITY_OR_OTHER||||||<|0.01||95.0||||The Statistical Analysis applies to the 7.5% hypertonic saline/6% Dextran-70 (HSD),7.5% hypertonic saline (HS), and 0.9% normal saline groups.|test for proportions|||The null hypothesis is that there are no differences in the percent of patients who died within 28 days from the time of the 911 call between the three groups among the patients who received zero units of PRBC.||||<0.01
72507118|NCT00772967|144546317|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.611||||0.089||90.0|-1.36|0.14||1-sided, alpha = 0.05|ANCOVA|Baseline measurement included as covariate: Time-weighted average pain intensity during pretreatment walk||||0.14|-1.36|0.089
72507119|NCT00772967|144546317|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.804||||0.043||90.0|-1.57|-0.04||1-sided, alpha = 0.05|ANCOVA|Baseline measurement included as covariate: Time-weighted average pain intensity during pretreatment walk||||-0.04|-1.57|0.043
72507120|NCT00772967|144546318|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.518||||0.048||90.0|-1.03|-0.01||1-sided, alpha = 0.05|ANCOVA|Baseline measurement included as covariate: Time-weighted average pain intensity during pretreatment walk||||-0.01|-1.03|0.048
72565859|NCT02709486|144662726|SUPERIORITY||LS Mean Ratio|0.74|STANDARD_ERROR_OF_MEAN|0.09||0.0112|TWO_SIDED|95.0|0.58|0.93|||Negative binomial model|||Week 4: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.||0.93|0.58|0.0112
72565860|NCT02709486|144662726|SUPERIORITY||LS Mean Ratio|0.72|STANDARD_ERROR_OF_MEAN|0.09||0.0093|TWO_SIDED|95.0|0.56|0.92|||Negative binomial model|||Week 8: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.||0.92|0.56|0.0093
72565861|NCT02709486|144662726|SUPERIORITY||LS Mean Ratio|0.75|STANDARD_ERROR_OF_MEAN|0.09||0.0237|TWO_SIDED|95.0|0.59|0.96|||Negative binomial model|||Week 8: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.||0.96|0.59|0.0237
72623080|NCT00835354|144776467|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model containing factors for sequence of products, subjects within sequence, periods, and products was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|89.2||||||90.0|86.2|92.2|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||92.2|86.2|
72398272|NCT03103919|144302716|SUPERIORITY||Mean Difference (Final Values)|-4.31|||=|0.134|TWO_SIDED|95.0|-10.04|1.41|||ANCOVA|The model used an ANCOVA with baseline as a covariate, center as factor, and group as main factor.|The difference presented is Experimental Group (Rotigotine + Standard Care + Kinesia-360™ wearable device FAS) minus Control Group (Rotigotine + Standard Care FAS).|||1.41|-10.04|=0.134
72473539|NCT00316017|144471151|SUPERIORITY_OR_OTHER|||||||0.51||95.0||||The Statistical Analysis applies to the 7.5% hypertonic saline/6% Dextran-70 (HSD),7.5% hypertonic saline (HS), and 0.9% normal saline groups.|test for proportions|||The null hypothesis is that there are no differences in the percent of patients who received 1-9 units PRBC in the first 24 hours between the three groups.||||0.51
72473540|NCT00316017|144471152|SUPERIORITY_OR_OTHER|||||||0.73||95.0||||The Statistical Analysis applies to the 7.5% hypertonic saline/6% Dextran-70 (HSD),7.5% hypertonic saline (HS), and 0.9% normal saline groups.|test for proportions|||The null hypothesis is that there are no differences in the percent of patients who died in Field or ED between the three groups among the patients who received 1-9 units of PRBC.||||0.73
72473541|NCT00316017|144471153|SUPERIORITY_OR_OTHER|||||||0.83||95.0||||The Statistical Analysis applies to the 7.5% hypertonic saline/6% Dextran-70 (HSD),7.5% hypertonic saline (HS), and 0.9% normal saline groups.|test for proportions|||The null hypothesis is that there are no differences in the percent of patients who died within 6 hours of admission to the hospital between the three groups among the patients who received 1-9 units of PRBC.||||0.83
72473542|NCT00316017|144471154|SUPERIORITY_OR_OTHER|||||||0.31||95.0||||The Statistical Analysis applies to the 7.5% hypertonic saline/6% Dextran-70 (HSD),7.5% hypertonic saline (HS), and 0.9% normal saline groups.|test for proportions|||The null hypothesis is that there are no differences in the percent of patients who died within 28 days from the time of the 911 call between the three groups among the patients who received 1-9 units of PRBC.||||0.31
72473543|NCT00316017|144471155|SUPERIORITY_OR_OTHER|||||||0.97||95.0||||The Statistical Analysis applies to the 7.5% hypertonic saline/6% Dextran-70 (HSD),7.5% hypertonic saline (HS), and 0.9% normal saline groups.|test for proportions|||The null hypothesis is that there are no differences in the percent of patients who received greater than 10 units of PRBC in first 24 hours between the three groups.||||0.97
72473544|NCT00316017|144471157|SUPERIORITY_OR_OTHER|||||||0.35||95.0||||The Statistical Analysis applies to the 7.5% hypertonic saline/6% Dextran-70 (HSD),7.5% hypertonic saline (HS), and 0.9% normal saline groups.|test for proportions|||The null hypothesis is that there are no differences in the percent of patients who died within 6 hours of admission to the hospital between the three groups among the patients who received greater than 10 units of PRBC.||||0.35
72473545|NCT00316017|144471158|SUPERIORITY_OR_OTHER|||||||0.34||95.0||||The Statistical Analysis applies to the 7.5% hypertonic saline/6% Dextran-70 (HSD),7.5% hypertonic saline (HS), and 0.9% normal saline groups.|test for proportions|||The null hypothesis is that there are no differences in the percent of patients who died within 28 days from the time of the 911 call between the three groups among the patients who received greater than 10 units of PRBC.||||0.34
72473546|NCT02671500|144471159|SUPERIORITY||||||<|0.001|||||||2-sided 1 sample exact binomial test|||A sample size of 260 participants in Region 1 would provide more than 80% power to detect an improvement of at least 6 percentage points in SVR12 rate from the performance goal of 85% by using a two-sided exact one-sample binomial test at the significance level of 0.05.||||<0.001
72565862|NCT02709486|144662726|SUPERIORITY||LS Mean Ratio|0.74|STANDARD_ERROR_OF_MEAN|0.11||0.0374|TWO_SIDED|95.0|0.56|0.98|||Negative binomial model|||Week 12: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.||0.98|0.56|0.0374
72565863|NCT02709486|144662726|SUPERIORITY||LS Mean Ratio|0.75|STANDARD_ERROR_OF_MEAN|0.11||0.0468|TWO_SIDED|95.0|0.57|1.0|||Negative binomial model|||Week 12: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.||1.00|0.57|0.0468
72623081|NCT00835354|144776468|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model containing factors for sequence of products, subjects within sequence, periods, and products was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|90.5||||||90.0|88.9|92.1|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||92.1|88.9|
72398273|NCT03103919|144302717|SUPERIORITY||Mean Difference (Final Values)|0.01|||=|0.982|TWO_SIDED|95.0|-0.44|0.45|||ANCOVA|The model used an ANCOVA with baseline as a covariate, center as factor, and group as main factor.|The difference presented is Experimental Group (Rotigotine + Standard Care + Kinesia-360™ wearable device FAS) minus Control Group (Rotigotine + Standard Care FAS).|||0.45|-0.44|=0.982
72473547|NCT05292586|144471166|SUPERIORITY||Adjusted mean difference|0.104|||<|0.001|TWO_SIDED|95.0|0.061|0.148|||ANCOVA|||"1\_Change from baseline~Statistical analysis used all available data and imputed missing data (i.e., whether due to missed visits, unperformed or unevaluable assessments at intermediate timepoints, or early study discontinuation) in ITT population (overall population N=283 in CHF 1535 pMDI 800/24 μg study group; N=280 in the CHF 718 pMDI 800 μg study group)."||0.148|0.061|<0.001
72473548|NCT05292586|144471167|SUPERIORITY||Adjusted mean difference|0.124|||<|0.001|TWO_SIDED|95.0|0.076|0.173|||ANCOVA|||"1\_Change from baseline~Statistical analysis used all available data and imputed missing data (i.e., whether due to missed visits, unperformed or unevaluable assessments at intermediate timepoints, or early study discontinuation) in ITT population (overall population N=283 in CHF 1535 pMDI 800/24 μg study group; N=280 in the CHF 718 pMDI 800 μg study group)."||0.173|0.076|<0.001
72507121|NCT00772967|144546318|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.03||||0.001||90.0|-1.54|-0.53||1-sided, alpha = 0.05|ANCOVA|Baseline measurement included as covariate: Time-weighted average pain intensity during pretreatment walk||||-0.53|-1.54|0.001
72507122|NCT00772967|144546319|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.658||||0.052||90.0|-1.32|0.01||1-sided, alpha = 0.05|ANCOVA|Baseline measurement included as covariate: Time-weighted average pain intensity during pretreatment walk||||0.01|-1.32|0.052
72507123|NCT00772967|144546319|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.15||||0.003||90.0|-1.81|-0.49||1-sided, alpha = 0.05|ANCOVA|Baseline measurement included as covariate: Time-weighted average pain intensity during pretreatment walk||||-0.49|-1.81|0.003
72507124|NCT00772967|144546320|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.875||||0.019||90.0|-1.56|-0.19||1-sided, alpha = 0.05|ANCOVA|Baseline measurement included as covariate: Time-weighted average pain intensity during pretreatment walk||||-0.19|-1.56|0.019
72507125|NCT00772967|144546320|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.07||||0.007||90.0|-1.77|-0.37||1-sided, alpha = 0.05|ANCOVA|Baseline measurement included as covariate: Time-weighted average pain intensity during pretreatment walk||||-0.37|-1.77|0.007
72507126|NCT04172831|144546357|SUPERIORITY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.16||0.01|TWO_SIDED|95.0|-0.7|-0.1|||Mixed Model Repeated Measures||Treatment Difference = TNX-102 - Placebo|||-0.1|-0.7|0.010
72507127|NCT04172831|144546358|SUPERIORITY||Odds Ratio (OR)|1.44||||0.058|TWO_SIDED|95.0|0.99|2.1|||Regression, Logistic|||||2.10|0.99|0.058
72507128|NCT04172831|144546359|SUPERIORITY||LS Mean Difference|-4.3|STANDARD_ERROR_OF_MEAN|1.6||0.007|TWO_SIDED|95.0|-7.5|-1.2|||Mixed Model Repeated Measures||Treatment Difference = TNX-102 - Placebo|||-1.2|-7.5|0.007
72398274|NCT03103919|144302718|SUPERIORITY||Mean Difference (Final Values)|-0.18|||=|0.566|TWO_SIDED|95.0|-0.81|0.45|||ANCOVA|The model used an ANCOVA with baseline as a covariate, center as factor, and group as main factor.|The difference presented is Experimental Group (Rotigotine + Standard Care + Kinesia-360™ wearable device FAS) minus Control Group (Rotigotine + Standard Care FAS).|||0.45|-0.81|=0.566
72507129|NCT04172831|144546360|SUPERIORITY||LS Mean Difference|-4.4|STANDARD_ERROR_OF_MEAN|1.69||0.009|TWO_SIDED|95.0|-7.7|-1.1|||Mixed Model Repeated Measures||Treatment Difference = TNX-102 - Placebo|||-1.1|-7.7|0.009
72507130|NCT04172831|144546361|SUPERIORITY||LS Mean Difference|-2.9|STANDARD_ERROR_OF_MEAN|0.82|<|0.001|TWO_SIDED|95.0|-4.5|-1.3|||Mixed Model Repeated Measures||Treatment Difference = TNX-102 - Placebo|||-1.3|-4.5|<0.001
72507131|NCT04172831|144546362|SUPERIORITY||LS Mean Difference|-1.8|STANDARD_ERROR_OF_MEAN|0.76||0.018|TWO_SIDED|95.0|-3.3|-0.3|||Mixed Model Repeated Measures||Treatment Difference = TNX-102 - Placebo|||-0.3|-3.3|0.018
72507132|NCT04172831|144546363|SUPERIORITY||LS Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.17|<|0.001|TWO_SIDED|95.0|-0.9|-0.3|||Mixed Model Repeated Measures||Treatment Difference = TNX-102 - Placebo|||-0.3|-0.9|<0.001
72507133|NCT01041573|144546364|SUPERIORITY_OR_OTHER_LEGACY|||||||0.641|||||||Fisher Exact|||||||0.641
72507134|NCT01041573|144546364|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Fisher Exact|||||||< 0.001
72507135|NCT01276847|144546379|SUPERIORITY_OR_OTHER|||||||0.016||95.0||||unadjusted 1-sided p-value, α = 0.05|Wilcoxon (Mann-Whitney)|One-sample test||Week 1||||0.016
72507136|NCT01276847|144546379|SUPERIORITY_OR_OTHER|||||||0.007||95.0||||unadjusted 1-sided p-value, α = 0.05|Wilcoxon (Mann-Whitney)|One-sample test||Week 2||||0.007
72507137|NCT01276847|144546379|SUPERIORITY_OR_OTHER|||||||0.00015||95.0||||unadjusted 1-sided p-value, α = 0.05|Wilcoxon (Mann-Whitney)|One-sample test||Week 4||||0.00015
72507138|NCT01276847|144546379|SUPERIORITY_OR_OTHER|||||||0.000184||95.0||||unadjusted 1-sided p-value, α = 0.05|Wilcoxon (Mann-Whitney)|One-sample test||Week 16||||0.000184
72507139|NCT01276847|144546380|SUPERIORITY_OR_OTHER|||||||0.397||95.0||||unadjusted 1-sided p-value, α = 0.05|Wilcoxon (Mann-Whitney)|One-sample test||Week 1||||0.397
72507140|NCT01276847|144546380|SUPERIORITY_OR_OTHER|||||||0.01||95.0||||unadjusted 1-sided p-value, α = 0.05|Wilcoxon (Mann-Whitney)|One-sample test||Week 2||||0.010
72507141|NCT01276847|144546380|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||unadjusted 1-sided p-value, α = 0.05|Wilcoxon (Mann-Whitney)|One-sample test||Week 4||||0.002
72507142|NCT01276847|144546380|SUPERIORITY_OR_OTHER|||||||0.000215||95.0||||unadjusted 1-sided p-value, α = 0.05|Wilcoxon (Mann-Whitney)|One-sample test||Week 16||||0.000215
72507143|NCT01276847|144546381|SUPERIORITY_OR_OTHER|||||||0.787||95.0||||unadjusted 1-sided p-value, α = 0.05|Wilcoxon (Mann-Whitney)|One-sample test||Week 1||||0.787
72507144|NCT01276847|144546381|SUPERIORITY_OR_OTHER|||||||0.577||95.0||||unadjusted 1-sided p-value, α = 0.05|Wilcoxon (Mann-Whitney)|One-sample test||Week 2||||0.577
72507145|NCT01276847|144546381|SUPERIORITY_OR_OTHER|||||||0.053||95.0||||unadjusted 1-sided p-value, α = 0.05|Wilcoxon (Mann-Whitney)|One-sample test||Week 4||||0.053
72507146|NCT01276847|144546381|SUPERIORITY_OR_OTHER|||||||0.098||95.0||||unadjusted 1-sided p-value, α = 0.05|Wilcoxon (Mann-Whitney)|One-sample test||Week 16||||0.098
72507147|NCT02986958|144546395|OTHER|We used generalized estimating equations with an exchangeable correlation structure to assess the direction, magnitude, and statistical significance of between-group differences. Regression models included treatment assignment and patient-level covariates (patient age, gender, and MMSE score) that were postulated as affecting communication outcomes. Statistical tests were 2-sided with a significance level of 0.05. Analyses were performed in SAS statistical software, version 9.4 (SAS, Cary, NC).|Mean Difference (Final Values)|0.16|STANDARD_ERROR_OF_MEAN|0.08||0.046|TWO_SIDED||||||t-test, 2 sided|||||||0.046
72507148|NCT01000064|144546422|SUPERIORITY_OR_OTHER|||||||0.053|TWO_SIDED|95.0|||||t-test, 2 sided|||||||0.053
72507149|NCT01000064|144546423|SUPERIORITY_OR_OTHER|||||||0.052|TWO_SIDED|95.0|||||t-test, 2 sided|||||||0.052
72473549|NCT05292586|144471168|SUPERIORITY||Adjusted mean difference|0.101|||<|0.001|TWO_SIDED|95.0|0.063|0.139|||ANCOVA|||"1\_Change from baseline~Statistical analysis used all available data and imputed missing data (i.e., whether due to missed visits, unperformed or unevaluable assessments at intermediate timepoints, or early study discontinuation) in ITT population (overall population N=283 in CHF 1535 pMDI 800/24 μg study group; N=280 in the CHF 718 pMDI 800 μg study group)."||0.139|0.063|<0.001
72473550|NCT05292586|144471169|SUPERIORITY||Adjusted mean difference|0.113|||<|0.001|TWO_SIDED|95.0|0.071|0.154|||ANCOVA|||"1\_Change from baseline~Statistical analysis used all available data and imputed missing data (i.e., whether due to missed visits, unperformed or unevaluable assessments at intermediate timepoints, or early study discontinuation) in ITT population (overall population N=283 in CHF 1535 pMDI 800/24 μg study group; N=280 in the CHF 718 pMDI 800 μg study group)."||0.154|0.071|<0.001
72473551|NCT05292586|144471170|SUPERIORITY||Adjusted mean difference|0.069||||0.003|TWO_SIDED|95.0|0.023|0.115|||ANCOVA|||"1\_Change from baseline~Statistical analysis used all available data and imputed missing data (i.e., whether due to missed visits, unperformed or unevaluable assessments at intermediate timepoints, or early study discontinuation) in ITT population (overall population N=283 in CHF 1535 pMDI 800/24 μg study group; N=280 in the CHF 718 pMDI 800 μg study group)."||0.115|0.023|0.003
72473552|NCT05292586|144471171|SUPERIORITY||Adjusted mean difference|0.044||||0.05|TWO_SIDED|95.0|0.0|0.088|||ANCOVA|||"1\_Change from baseline -- Week 4~Statistical analysis used all available data and imputed missing data (i.e., whether due to missed visits, unperformed or unevaluable assessments at intermediate timepoints, or early study discontinuation) in ITT population (overall population N=283 in CHF 1535 pMDI 800/24 μg study group; N=280 in the CHF 718 pMDI 800 μg study group)."||0.088|0.000|0.050
72473553|NCT05292586|144471171|SUPERIORITY||Adjusted mean difference|0.041||||0.098|TWO_SIDED|95.0|-0.007|0.089|||ANCOVA|||"2\_Change from baseline -- Week 8~Statistical analysis used all available data and imputed missing data (i.e., whether due to missed visits, unperformed or unevaluable assessments at intermediate timepoints, or early study discontinuation) in ITT population (overall population N=283 in CHF 1535 pMDI 800/24 μg study group; N=280 in the CHF 718 pMDI 800 μg study group)."||0.089|-0.007|0.098
72473554|NCT05292586|144471171|SUPERIORITY||Adjusted mean difference|0.043||||0.056|TWO_SIDED|95.0|-0.001|0.086|||ANCOVA|||"3\_Change from baseline -- Week 12~Statistical analysis used all available data and imputed missing data (i.e., whether due to missed visits, unperformed or unevaluable assessments at intermediate timepoints, or early study discontinuation) in ITT population (overall population N=283 in CHF 1535 pMDI 800/24 μg study group; N=280 in the CHF 718 pMDI 800 μg study group)."||0.086|-0.001|0.056
72473555|NCT05292586|144471172|SUPERIORITY||Odds Ratio (OR)|1.327||||0.098|TWO_SIDED|95.0|0.949|1.855|||Logistic regression model|||1\_Responders at Week 4||1.855|0.949|0.098
72507150|NCT01000064|144546424|SUPERIORITY_OR_OTHER|||||||0.047|TWO_SIDED||||||t-test, 2 sided|||||||0.047
72398275|NCT03103919|144302719|SUPERIORITY||Mean Difference (Final Values)|-0.07|||=|0.72|TWO_SIDED|95.0|-0.5|0.35|||ANCOVA|The model used an ANCOVA with baseline as a covariate, center as factor, and group as main factor.|The difference presented is Experimental Group (Rotigotine + Standard Care + Kinesia-360™ wearable device FAS) minus Control Group (Rotigotine + Standard Care FAS).|||0.35|-0.50|=0.720
72473556|NCT05292586|144471172|SUPERIORITY||Odds Ratio (OR)|1.262||||0.18|TWO_SIDED|95.0|0.898|1.772|||Logistic regression model|||2\_Responders at Week 8||1.772|0.898|0.180
72473557|NCT05292586|144471172|SUPERIORITY||Odds Ratio (OR)|1.568||||0.009|TWO_SIDED|95.0|1.117|2.203|||Logistic regression model|||3\_Responders at Week 12||2.203|1.117|0.009
72473558|NCT05292586|144471173|SUPERIORITY||Odds Ratio (OR)|1.822|||<|0.001|TWO_SIDED|95.0|1.284|2.587|||Logistic regression model|||1\_Responders at Week 12||2.587|1.284|<0.001
72507151|NCT01000064|144546425|SUPERIORITY_OR_OTHER|||||||0.047|TWO_SIDED||||||t-test, 2 sided|||||||0.047
72507152|NCT01000064|144546426|SUPERIORITY_OR_OTHER|||||||0.003|TWO_SIDED||||||t-test, 2 sided|||||||0.003
72473559|NCT05292586|144471174|SUPERIORITY||Adjusted mean difference|8.78||||0.002|TWO_SIDED|95.0|3.3|14.27|||ANCOVA|||"1\_Change From Baseline; Week 0 -- Week 12~Statistical analysis used all available data and imputed missing data (i.e., whether due to missed visits, unperformed or unevaluable assessments at intermediate timepoints, or early study discontinuation) in ITT population (overall population N=283 in CHF 1535 pMDI 800/24 μg study group; N=280 in the CHF 718 pMDI 800 μg study group)."||14.27|3.30|0.002
72473560|NCT05292586|144471175|SUPERIORITY||Adjusted mean difference|8.73||||0.002|TWO_SIDED|95.0|3.32|14.14|||ANCOVA|||"1\_Change From Baseline; Week 0 -- Week 12~Statistical analysis used all available data and imputed missing data (i.e., whether due to missed visits, unperformed or unevaluable assessments at intermediate timepoints, or early study discontinuation) in ITT population (overall population N=283 in CHF 1535 pMDI 800/24 μg study group; N=280 in the CHF 718 pMDI 800 μg study group)."||14.14|3.32|0.002
72473561|NCT05292586|144471176|SUPERIORITY||Adjusted mean difference|-0.112||||0.026|TWO_SIDED|95.0|-0.211|-0.013|||ANCOVA|||"1\_Change From Baseline in ACQ-7 at Week 12~Statistical analysis used all available data and imputed missing data (i.e., whether due to missed visits, unperformed or unevaluable assessments at intermediate timepoints, or early study discontinuation) in ITT population (overall population N=283 in CHF 1535 pMDI 800/24 μg study group; N=280 in the CHF 718 pMDI 800 μg study group)."||-0.013|-0.211|0.026
72507153|NCT01000064|144546427|SUPERIORITY_OR_OTHER|||||||0.04|TWO_SIDED||||||t-test, 2 sided|||||||0.040
72507154|NCT01000064|144546428|SUPERIORITY_OR_OTHER|||||||0.047|TWO_SIDED||||||t-test, 2 sided|||||||0.047
72507155|NCT03141307|144546445|EQUIVALENCE|95% margin|||||<|0.001||||||a priori threshold for statistical significance set for p \< .05|t-test, 2 sided|||||||<.001
72507156|NCT03141307|144546446|EQUIVALENCE|95% margin|||||<|0.05||||||a priori threshold for statistical significance set for p \< .05|t-test, 2 sided|||||||<.05
72507157|NCT03141307|144546447|EQUIVALENCE|95% margin|||||=|0.502||||||a priori threshold for statistical significance set for p \< .05|t-test, 2 sided|||||||=.502
72507158|NCT03141307|144546448|EQUIVALENCE|95% margin|||||=|0.071||||||a priori threshold for statistical significance set for p \< .05|t-test, 2 sided|||||||=.071
72507159|NCT03141307|144546449|EQUIVALENCE|95% margin|||||=|0.124||||||a prior threshold for statistical significance set for p \< .05.|t-test, 2 sided|||||||=.124
72507160|NCT03141307|144546450|EQUIVALENCE|95% margin|||||<|0.05||||||a priori threshold for statistical significance set for p \< .05|t-test, 2 sided|||||||<.05
72507161|NCT04430582|144546458|OTHER|||||||0.9|||||||Wilcoxon (Mann-Whitney)|||||||0.90
72507162|NCT04430582|144546459|OTHER|||||||0.24|||||||Wilcoxon (Mann-Whitney)|||||||0.24
72507163|NCT04430582|144546460|OTHER|||||||0.74|||||||Wilcoxon (Mann-Whitney)|||||||0.74
72473562|NCT05292586|144471176|SUPERIORITY||Adjusted mean difference|0.02||||0.686|TWO_SIDED|95.0|-0.077|0.118|||ANCOVA|||"2\_Change from baseline in ACQ-5 at Week 12~Statistical analysis used all available data and imputed missing data (i.e., whether due to missed visits, unperformed or unevaluable assessments at intermediate timepoints, or early study discontinuation) in ITT population (overall population N=283 in CHF 1535 pMDI 800/24 μg study group; N=280 in the CHF 718 pMDI 800 μg study group)."||0.118|-0.077|0.686
72398276|NCT03103919|144302720|SUPERIORITY||Mean Difference (Final Values)|0.15|||=|0.443|TWO_SIDED|95.0|-0.24|0.53|||ANCOVA|The model used an ANCOVA with baseline as a covariate, center as factor, and group as main factor.|The difference presented is Experimental Group (Rotigotine + Standard Care + Kinesia-360™ wearable device FAS) minus Control Group (Rotigotine + Standard Care FAS).|||0.53|-0.24|=0.443
72473563|NCT05292586|144471177|SUPERIORITY||Adjusted mean difference|3.82||||0.033|TWO_SIDED|95.0|0.31|7.33|||ANCOVA|||"1\_Change From Baseline~Statistical analysis used all available data and imputed missing data (i.e., whether due to missed visits, unperformed or unevaluable assessments at intermediate timepoints, or early study discontinuation) in ITT population (overall population N=283 in CHF 1535 pMDI 800/24 μg study group; N=280 in the CHF 718 pMDI 800 μg study group)."||7.330|0.310|0.033
72473564|NCT05292586|144471178|SUPERIORITY||Adjusted mean difference|3.78||||0.078|TWO_SIDED|95.0|-0.425|7.985|||ANCOVA|||"1\_Change From Baseline~Statistical analysis used all available data and imputed missing data (i.e., whether due to missed visits, unperformed or unevaluable assessments at intermediate timepoints, or early study discontinuation) in ITT population (overall population N=283 in CHF 1535 pMDI 800/24 μg study group; N=280 in the CHF 718 pMDI 800 μg study group)."||7.985|-0.425|0.078
72473565|NCT03841526|144471183|OTHER|Parameters that did not meet normality criterion were analyzed non-parametrically. Overall treatment effect was assessed using Friedman's test.||||||0.0002|||||||ANOVA|||The primary efficacy analysis was analyzed by analysis of variance (ANOVA) comparing the mean incidence rates among the 3 treatment groups in the Outpatient Phase. If the performed Friedman's test yielded an overall p-value less than 0.05, post-hoc analysis of groups means were conducted to statistically determine which group means differed.||||0.0002
72473566|NCT03841526|144471183|OTHER||||||<|0.0001|||||||Tukey Test/Kruskal-Wallis Test|Tukey Test (if the difference between 2 treatments was normally distributed) or Kruskal-Wallis Test (if not normally distributed).||If the overall treatment effect was significant, pairwise treatment comparisons were assessed using: If a difference between 2 treatments was normally distributed, the Tukey Test was used or if not normally distributed and the distribution was highly skewed, the sign test/Kruskal-Allis test was used.||||<0.0001
72473567|NCT03841526|144471183|OTHER|||||||0.0032|||||||Tukey Test/Kruskal-Wallis Test|Tukey Test (if the difference between 2 treatments was normally distributed) or Kruskal-Wallis Test (if not normally distributed).||If the overall treatment effect was significant, pairwise treatment comparisons were assessed using: If a difference between 2 treatments was normally distributed, the Tukey Test was used or if not normally distributed and the distribution was highly skewed, the sign test/Kruskal-Allis test was used.||||0.0032
72473568|NCT03841526|144471183|OTHER|||||||0.2072|||||||Tukey Test/Kruskal-Wallis Test|Tukey Test (if the difference between 2 treatments was normally distributed) or Kruskal-Wallis Test (if not normally distributed).||If the overall treatment effect was significant, pairwise treatment comparisons were assessed using: If a difference between 2 treatments was normally distributed, the Tukey Test was used or if not normally distributed and the distribution was highly skewed, the sign test/Kruskal-Allis test was used.||||0.2072
72473569|NCT03841526|144471186|OTHER|||||||1|||||||Fisher Exact|||||||1.0000
72473570|NCT03841526|144471187|OTHER|||||||0.859|||||||Chi-squared|||||||0.8590
72473572|NCT01498887|144471246|SUPERIORITY_OR_OTHER|||||||0.3118|||||||Wilcoxon (Mann-Whitney)|||||||0.3118
72473573|NCT03079297|144471253|SUPERIORITY||Mean Difference (Final Values)|2.0|STANDARD_ERROR_OF_MEAN|2.5||0.4128|TWO_SIDED|95.0|-3.56|7.56|||t-test, 2 sided|||||7.56|-3.56|0.4128
72473574|NCT03079297|144471254|SUPERIORITY|||||||0.4286|||||||Fisher Exact|||||||0.4286
72473575|NCT03079297|144471255|SUPERIORITY|||||||0.999|||||||Fisher Exact|||||||.999
72473576|NCT03079297|144471256|SUPERIORITY|||||||0.9932||||||P-value for Adverse effect burden 3 days Change. Model: Change from baseline=Baseline, Visit, Treatment, Treatment\*Visit|MMRM|||||||0.9932
72473577|NCT03079297|144471256|SUPERIORITY|||||||0.9932||||||P-value for Adverse effect burden 7 days Change. Model: Change from baseline=Baseline, Visit, Treatment, Treatment\*Visit|MMRM|||||||0.9932
72473578|NCT03079297|144471256|SUPERIORITY|||||||0.2242||||||P-value for Adverse effect burden 14 days Change. Model: Change from baseline=Baseline, Visit, Treatment, Treatment\*Visit|MMRM|||||||0.2242
72473579|NCT03079297|144471257|SUPERIORITY|||||||0.7282||||||P-value for General fatigue 3 days Change. Model: Change from baseline=Baseline, Visit, Treatment, Treatment\*Visit|MMRM|||||||0.7282
72473580|NCT03079297|144471257|SUPERIORITY|||||||0.8781||||||P-value for General fatigue 7 days Change. Model: Change from baseline=Baseline, Visit, Treatment, Treatment\*Visit|MMRM|||||||0.8781
72473581|NCT03079297|144471257|SUPERIORITY|||||||0.226||||||P-value for General fatigue 14 days Change. Model: Change from baseline=Baseline, Visit, Treatment, Treatment\*Visit|MMRM|||||||0.226
72473582|NCT03079297|144471257|SUPERIORITY|||||||0.2158||||||P-value for Mental fatigue 3 days Change. Model: Change from baseline=Baseline, Visit, Treatment, Treatment\*Visit|MMRM|||||||0.2158
72473583|NCT03079297|144471257|SUPERIORITY|||||||0.0081||||||P-value for Mental fatigue 7 days Change. Model: Change from baseline=Baseline, Visit, Treatment, Treatment\*Visit|MMRM|||||||0.0081
72473584|NCT03079297|144471257|SUPERIORITY|||||||0.6768||||||P-value for Mental fatigue 14 days Change. Model: Change from baseline=Baseline, Visit, Treatment, Treatment\*Visit|MMRM|||||||0.6768
72473585|NCT03079297|144471257|SUPERIORITY|||||||0.0076||||||P-value for Physical fatigue 3 days Change. Model: Change from baseline=Baseline, Visit, Treatment, Treatment\*Visit|MMRM|||||||0.0076
72473586|NCT03079297|144471257|SUPERIORITY|||||||0.0858||||||P-value for Physical fatigue 7 days Change. Model: Change from baseline=Baseline, Visit, Treatment, Treatment\*Visit|MMRM|||||||0.0858
72473587|NCT03079297|144471257|SUPERIORITY|||||||0.2065||||||P-value for Physical fatigue 14 days Change. Model: Change from baseline=Baseline, Visit, Treatment, Treatment\*Visit|MMRM|||||||0.2065
72473588|NCT03079297|144471257|SUPERIORITY|||||||0.9712||||||P-value for Reduced motivation 3 days Change. Model: Change from baseline=Baseline, Visit, Treatment, Treatment\*Visit|MMRM|||||||0.9712
72473589|NCT03079297|144471257|SUPERIORITY|||||||0.7572||||||P-value for Reduced motivation 7 days Change. Model: Change from baseline=Baseline, Visit, Treatment, Treatment\*Visit|MMRM|||||||0.7572
72398277|NCT03103919|144302721|SUPERIORITY||Mean Difference (Final Values)|-0.09|||=|0.777|TWO_SIDED|95.0|-0.75|0.57|||ANCOVA|The model used an ANCOVA with baseline as a covariate, center as factor, and group as main factor.|The difference presented is Experimental Group (Rotigotine + Standard Care + Kinesia-360™ wearable device FAS) minus Control Group (Rotigotine + Standard Care FAS).|||0.57|-0.75|=0.777
72398278|NCT03103919|144302722|SUPERIORITY||Mean Difference (Final Values)|-0.01|||=|0.947|TWO_SIDED|95.0|-0.33|0.31|||ANCOVA|The model used an ANCOVA with baseline as a covariate, center as factor, and group as main factor.|The difference presented is Experimental Group (Rotigotine + Standard Care + Kinesia-360™ wearable device FAS) minus Control Group (Rotigotine + Standard Care FAS).|||0.31|-0.33|=0.947
72398279|NCT03103919|144302723|SUPERIORITY||Mean Difference (Final Values)|-0.27|||=|0.306|TWO_SIDED|95.0|-0.79|0.26|||ANCOVA|The model used an ANCOVA with baseline as a covariate, center as factor, and group as main factor.|The difference presented is Experimental Group (Rotigotine + Standard Care + Kinesia-360™ wearable device FAS) minus Control Group (Rotigotine + Standard Care FAS).|||0.26|-0.79|=0.306
72473590|NCT03079297|144471257|SUPERIORITY|||||||0.0588||||||P-value for Reduced motivation 14 days Change. Model: Change from baseline=Baseline, Visit, Treatment, Treatment\*Visit|MMRM|||||||0.0588
72473591|NCT03079297|144471257|SUPERIORITY|||||||0.1857||||||P-value for Reduced activity 3 days Change. Model: Change from baseline=Baseline, Visit, Treatment, Treatment\*Visit|MMRM|||||||0.1857
72473592|NCT03079297|144471257|SUPERIORITY|||||||0.9225||||||P-value for Reduced activity 7 days Change. Model: Change from baseline=Baseline, Visit, Treatment, Treatment\*Visit|MMRM|||||||0.9225
72507164|NCT04430582|144546461|OTHER|||||||0.51|||||||Wilcoxon (Mann-Whitney)|||||||0.51
72623082|NCT00835354|144776469|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model containing factors for sequence of products, subjects within sequence, periods, and products was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|90.7||||||90.0|89.1|92.3|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||92.3|89.1|
72398280|NCT03103919|144302724|SUPERIORITY||Mean Difference (Final Values)|0.03|||=|0.819|TWO_SIDED|95.0|-0.25|0.31|||ANCOVA|The model used an ANCOVA with baseline as a covariate, center as factor, and group as main factor.|The difference presented is Experimental Group (Rotigotine + Standard Care + Kinesia-360™ wearable device FAS) minus Control Group (Rotigotine + Standard Care FAS).|||0.31|-0.25|=0.819
72398281|NCT03103919|144302725|SUPERIORITY||Mean Difference (Final Values)|0.07|||=|0.663|TWO_SIDED|95.0|-0.26|0.41|||ANCOVA|The model used an ANCOVA with baseline as a covariate, center as factor, and group as main factor.||||0.41|-0.26|=0.663
72398282|NCT03103919|144302726|SUPERIORITY||Mean Difference (Final Values)|-0.2|||=|0.197|TWO_SIDED|95.0|-0.51|0.11|||ANCOVA|The model used an ANCOVA with baseline as a covariate, center as factor, and group as main factor.||||0.11|-0.51|=0.197
72507165|NCT04430582|144546462|OTHER|||||||0.7|||||||Wilcoxon (Mann-Whitney)|||||||0.70
72398283|NCT03103919|144302729|SUPERIORITY||Odds Ratio (OR)|1.14|||=|0.876|TWO_SIDED|95.0|0.23|5.66||P-values for the comparison of treatment groups have been calculated using logistic regression with factors for treatment and center.|Regression, Logistic||Odds ratio was calculated as Control Group/Experimental Group (Rotigotine + Standard Care SS / Rotigotine + Standard Care + Kinesia-360™ wearable device SS) calculated using logistic regression with factors for treatment and center.|||5.66|0.23|=0.876
72398284|NCT02707991|144302747|SUPERIORITY||Mean Difference (Final Values)|22.0|STANDARD_ERROR_OF_MEAN|0.115||0.036|ONE_SIDED|||||one-sided test|z-test for difference in proportions|||||||0.036
72398285|NCT02157298|144302782|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.1053|<|0.0001|TWO_SIDED|95.0|-0.81|-0.39||Significant at alpha=0.05 (two-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure|Mixed Models Analysis|with fixed categorical effects of treatment, week, DPP-4, baseline eGFR, treatment-by-week interaction, continuous fixed covariate of baseline value.||H0: mean(dapa) minus mean(placebo) = 0 versus alternative HA: mean(dapa) minus mean(placebo) =/= 0||-0.39|-0.81|<0.0001
72473593|NCT03079297|144471257|SUPERIORITY|||||||0.0414||||||P-value for Reduced activity 14 days Change. Model: Change from baseline=Baseline, Visit, Treatment, Treatment\*Visit|MMRM|||||||0.0414
72473594|NCT03079297|144471258|SUPERIORITY|||||||0.4603||||||P-value for Psychosocial function 3 days Change. Model: Change from baseline=Baseline, Visit, Treatment, Treatment\*Visit|MMRM|||||||0.4603
72473595|NCT03079297|144471258|SUPERIORITY|||||||0.2521||||||P-value for Psychosocial function 7 days Change. Model: Change from baseline=Baseline, Visit, Treatment, Treatment\*Visit|MMRM|||||||0.2521
72473596|NCT03079297|144471258|SUPERIORITY|||||||0.6635||||||P-value for Psychosocial function 14 days Change. Model: Change from baseline=Baseline, Visit, Treatment, Treatment\*Visit|MMRM|||||||0.6635
72473597|NCT03079297|144471259|SUPERIORITY|||||||0.7839||||||P-value for Anhedonia 3 days Change. Model: Change from baseline=Baseline, Visit, Treatment, Treatment\*Visit|MMRM|||||||0.7839
72473598|NCT03079297|144471259|SUPERIORITY|||||||0.0248||||||P-value for Anhedonia function 7 days Change. Model: Change from baseline=Baseline, Visit, Treatment, Treatment\*Visit|MMRM|||||||0.0248
72473599|NCT03079297|144471259|SUPERIORITY|||||||0.0199||||||P-value for Anhedonia 14 days Change. Model: Change from baseline=Baseline, Visit, Treatment, Treatment\*Visit|MMRM|||||||0.0199
72473600|NCT02993406|144471262|SUPERIORITY||Hazard Ratio (HR)|0.87||||0.004|TWO_SIDED|95.0|0.79|0.96|||Log Rank|||||0.96|0.79|0.004
72473601|NCT02993406|144471263|SUPERIORITY||Hazard Ratio (HR)|0.85||||0.0058|TWO_SIDED|95.0|0.76|0.96|||Log Rank|||||0.96|0.76|0.0058
72473602|NCT02993406|144471264|SUPERIORITY||Hazard Ratio (HR)|0.77||||0.0016|TWO_SIDED|95.0|0.66|0.91|||Log Rank|||||0.91|0.66|0.0016
72507166|NCT04430582|144546463|OTHER|||||||0.95|||||||Kruskal-Wallis|||||||0.95
72398286|NCT02157298|144302783|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-22.7|STANDARD_ERROR_OF_MEAN|5.301|<|0.0001|TWO_SIDED|95.0|-33.2|-12.2||Significant at alpha=0.05 (two-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure|Mixed Models Analysis|with fixed categorical effects of treatment, week, DPP-4, baseline eGFR, treatment-by-week interaction, continuous fixed covariate of baseline value.||H0: mean(dapa) minus mean(placebo) = 0 versus alternative HA: mean(dapa) minus mean(placebo) =/= 0||-12.2|-33.2|<0.0001
72398287|NCT02157298|144302784|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.2|STANDARD_ERROR_OF_MEAN|0.255|<|0.0001|TWO_SIDED|95.0|-1.7|-0.7||Significant at alpha=0.05 (two-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure|Mixed Models Analysis|with fixed categorical effects of treatment, week, DPP-4, baseline eGFR, treatment-by-week interaction, continuous fixed covariate of baseline value.||H0: mean(dapa) minus mean(placebo) = 0 versus alternative HA: mean(dapa) minus mean(placebo) =/= 0||-0.7|-1.7|<0.0001
72473603|NCT02993406|144471265|SUPERIORITY||Hazard Ratio (HR)|0.81||||0.0013|TWO_SIDED|95.0|0.72|0.92|||Log Rank|||||0.92|0.72|0.0013
72473604|NCT02993406|144471266|SUPERIORITY||Hazard Ratio (HR)|0.85||||0.1593|TWO_SIDED|95.0|0.67|1.07|||Log Rank|||||1.07|0.67|0.1593
72473605|NCT02993406|144471267|SUPERIORITY||Hazard Ratio (HR)|1.04||||0.6227|TWO_SIDED|95.0|0.88|1.24|||Log Rank|||||1.24|0.88|0.6227
72473606|NCT02993406|144471268|SUPERIORITY||Hazard Ratio (HR)|1.03||||0.6608|TWO_SIDED|95.0|0.9|1.18|||Log Rank|||||1.18|0.90|0.6608
72507167|NCT04430582|144546464|OTHER|||||||0.48|||||||Wilcoxon (Mann-Whitney)|||||||0.48
72507168|NCT04430582|144546465|OTHER|||||||0.85|||||||Wilcoxon (Mann-Whitney)|||||||0.85
72507169|NCT04430582|144546466|OTHER|||||||0.01|||||||Wilcoxon (Mann-Whitney)|||||||0.01
72507170|NCT04430582|144546467|OTHER|||||||0.01|||||||Wilcoxon (Mann-Whitney)|||||||0.01
72507171|NCT04430582|144546468|OTHER|||||||0.03|||||||Wilcoxon (Mann-Whitney)|||||||0.03
72507172|NCT04430582|144546469|OTHER|||||||0.03|||||||Wilcoxon (Mann-Whitney)|||||||0.03
72507173|NCT04430582|144546470|OTHER|||||||0.3|||||||Wilcoxon (Mann-Whitney)|||||||0.30
72507174|NCT04430582|144546471|OTHER|||||||0.045|||||||Wilcoxon (Mann-Whitney)|||||||0.045
72507175|NCT04430582|144546472|OTHER|||||||0.37|||||||Wilcoxon (Mann-Whitney)|||||||0.37
72507176|NCT03151148|144546483|SUPERIORITY||Risk Ratio (RR)|0.56||||0.075|TWO_SIDED|95.0|0.29|1.06|||Negative Binomial Regression|Negative binomial generalized linear model, adjusting for site, offset by follow-up days within the outcome measure time frame|TMT represents the numerator, placebo represents the denominator|||1.06|0.29|0.075
72507177|NCT03151148|144546484|SUPERIORITY||Risk Difference (RD)|-0.28||||0.044|TWO_SIDED|95.0|-0.51|-0.04|||Chi-squared||95% exact unconditional confidence interval is based on the Santner and Snell method|||-0.04|-0.51|0.044
72507178|NCT03151148|144546485|SUPERIORITY||Risk Ratio (RR)|0.63||||0.121|TWO_SIDED|95.0|0.36|1.13|||Negative Binomial Regression|Negative binomial generalized linear model, adjusting for site, offset by follow-up days within the outcome measure time frame|TMT represents the numerator, placebo represents the denominator|||1.13|0.36|0.121
72507179|NCT03151148|144546486|SUPERIORITY||Risk Difference (RD)|-0.25||||0.053|TWO_SIDED|95.0|-0.46|-0.04|||Chi-squared||95% exact unconditional confidence interval is based on the Santner and Snell method|||-0.04|-0.46|0.053
72507180|NCT03151148|144546491|SUPERIORITY||Geometric mean ratio (GMR)|2.76||||0.261|TWO_SIDED|95.0|0.469|16.226|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs. Non-lesional within TMT at Day 0~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||16.226|0.469|0.261
72507181|NCT03151148|144546491|SUPERIORITY||Geometric mean ratio (GMR)|0.41||||0.319|TWO_SIDED|95.0|0.069|2.393|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs. Non-lesional within TMT at Day 4~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||2.393|0.069|0.319
72507182|NCT03151148|144546491|SUPERIORITY||Geometric mean ratio (GMR)|1.02||||0.978|TWO_SIDED|95.0|0.174|6.027|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs. Non-lesional within TMT at Day 7~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||6.027|0.174|0.978
72507183|NCT03151148|144546491|SUPERIORITY||Geometric mean ratio (GMR)|3.44||||0.177|TWO_SIDED|95.0|0.57|20.749|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs. Non-lesional within TMT at Day 8~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||20.749|0.570|0.177
72565864|NCT02709486|144662726|SUPERIORITY||LS Mean Ratio|0.78|STANDARD_ERROR_OF_MEAN|0.11||0.0751|TWO_SIDED|95.0|0.59|1.03|||Negative binomial model|||Week 16: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.||1.03|0.59|0.0751
72473607|NCT05262517|144471269|OTHER||Least square (LS) mean difference|-0.15|||||TWO_SIDED|95.0|-1.78|1.48||||||LS means and CIs were estimated by an analysis of covariance (ANCOVA) model, using restricted maximum likelihood (REML) with baseline NRS value as a covariate and treatment group and stratification factor (use of daily medications/ oral devices to reduce the intensity of TMD symptoms) as the main effects.||1.48|-1.78|
72473608|NCT05262517|144471270|OTHER||LS mean difference|5.12|||||TWO_SIDED|95.0|-21.35|31.59||||||LS means and CIs were estimated by an analysis of covariance model using REML with baseline NRS value as a covariate and treatment group and stratification factor (use of daily medications/ oral devices to reduce the intensity of TMD symptoms) as the main effects.||31.59|-21.35|
72473609|NCT05262517|144471271|OTHER||LS mean difference|0.21|||||TWO_SIDED|95.0|-0.99|1.41||||||LS means, and CIs were based on a generalized linear mixed effect model (GLMEM) that included the baseline value as a covariate and fixed effects for treatment group, stratification factor (use of daily medications/ oral devices to reduce the intensity of TMD symptoms; yes or no), scheduled time point, and time point by-treatment group interaction.||1.41|-0.99|
72473610|NCT05262517|144471272|OTHER||Difference in percentage|-5.2|||||TWO_SIDED|95.0|-21.3|10.9||||||Stratified by use of daily medications/ oral devices to reduce the intensity of TMD symptoms at randomization with Mantel-Haenzsel weighting.||10.9|-21.3|
72473611|NCT05262517|144471275|OTHER||Difference in percentage|4.0|||||TWO_SIDED|95.0|-8.7|16.6||||||Stratified by use of daily medications/oral devices to reduce the intensity of TMD symptoms at randomization with Mantel-Haenszel weighting.||16.6|-8.7|
72473612|NCT04325282|144471276|OTHER|||||||0.04||||||The a priori threshold for statistical significance was \<0.05.|Wilcoxon signed rank test|||Within-group analysis of change after active rTMS (post-rTMS compared to pre-rTMS).||||0.04
72473613|NCT04325282|144471276|OTHER|||||||0.46||||||The a priori threshold for statistical significance was \<0.05.|Wilcoxon signed rank test|||Within-group analysis of change after sham rTMS (post-rTMS compared to pre-rTMS).||||0.46
72473614|NCT04325282|144471276|OTHER|||||||0.12||||||The a priori threshold for statistical significance was \<0.05.|Wilcoxon signed rank test|||Between-group analysis of change induced by active rTMS versus sham rTMS||||0.12
72473615|NCT04325282|144471277|OTHER|Given the multiple ROIs investigated, we adjusted significance thresholds using principal component analysis, which accounts for the effective number of independent tests. This method is suitable when data in each comparison are not completely independent, as is the case with EEG where signal represents summated activity from multiple regions.|||||<|0.0001||||||The threshold for statistical significance was p \< 0.0076.|Wilcoxon signed-rank test|||Within-group analysis of change in cF-iT connectivity during active rTMS (post-rTMS versus pre-rTMS).||||<0.0001
72473616|NCT04325282|144471277|OTHER|Given the multiple ROIs investigated, we adjusted significance thresholds using principal component analysis, which accounts for the effective number of independent tests. This method is suitable when data in each comparison are not completely independent, as is the case with EEG where signal represents summated activity from multiple regions.||||||0.69||||||The threshold for statistical significance was p \< 0.0076.|Wilcoxon signed rank test|||Within-group analysis of change in cF-iT connectivity during sham rTMS (post-rTMS versus pre-rTMS).||||0.69
72473617|NCT04325282|144471277|OTHER|Given the multiple ROIs investigated, we adjusted significance thresholds using principal component analysis, which accounts for the effective number of independent tests. This method is suitable when data in each comparison are not completely independent, as is the case with EEG where signal represents summated activity from multiple regions.|||||<|0.0001||||||The threshold for statistical significance was p \< 0.0071.|Wilcoxon signed rank test|||Between-group analysis of change in cF-iT connectivity induced by active versus sham rTMS.||||<0.0001
72473618|NCT04325282|144471277|OTHER|Given the multiple ROIs investigated, we adjusted significance thresholds using principal component analysis, which accounts for the effective number of independent tests. This method is suitable when data in each comparison are not completely independent, as is the case with EEG where signal represents summated activity from multiple regions.|||||<|0.0001||||||The threshold for statistical significance was p \< 0.0076.|Wilcoxon signed rank test|||Within-group analysis of change in cM-iT connectivity during active rTMS (post-rTMS versus pre-rTMS).||||<0.0001
72473619|NCT04325282|144471277|OTHER|Given the multiple ROIs investigated, we adjusted significance thresholds using principal component analysis, which accounts for the effective number of independent tests. This method is suitable when data in each comparison are not completely independent, as is the case with EEG where signal represents summated activity from multiple regions.||||||0.43||||||The threshold for statistical significance was p \< 0.0076.|Wilcoxon signed rank test|||Within-group analysis of change in cM-iT connectivity during sham rTMS (post-rTMS versus pre-rTMS).||||0.43
72507184|NCT03151148|144546491|SUPERIORITY||Geometric mean ratio (GMR)|1.7||||0.558|TWO_SIDED|95.0|0.288|9.973|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs. Non-lesional within TMT at Day 11~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||9.973|0.288|0.558
72507185|NCT03151148|144546491|SUPERIORITY||Geometric mean ratio (GMR)|1.04||||0.977|TWO_SIDED|95.0|0.082|13.151|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs. Non-lesional within Placebo at Day 0~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||13.151|0.082|0.977
72565865|NCT02709486|144662726|SUPERIORITY||LS Mean Ratio|0.81|STANDARD_ERROR_OF_MEAN|0.11||0.1305|TWO_SIDED|95.0|0.61|1.06|||Negative binomial model|||Week 16: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.||1.06|0.61|0.1305
72398288|NCT02157298|144302785|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.72|STANDARD_ERROR_OF_MEAN|0.4017||0.0743|TWO_SIDED|95.0|-1.51|0.07||Significant at alpha=0.05 (two-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure|Mixed Models Analysis|with fixed categorical effects of treatment, week, DPP-4, baseline eGFR, treatment-by-week interaction, continuous fixed covariate of baseline value.||H0: mean(dapa) minus mean(placebo) = 0 versus alternative HA: mean(dapa) minus mean(placebo) =/= 0||0.07|-1.51|0.0743
72473620|NCT04325282|144471277|OTHER|Given the multiple ROIs investigated, we adjusted significance thresholds using principal component analysis, which accounts for the effective number of independent tests. This method is suitable when data in each comparison are not completely independent, as is the case with EEG where signal represents summated activity from multiple regions.|||||<|0.0001||||||The threshold for statistical significance was p \< 0.0071.|Wilcoxon signed rank test|||Between-group analysis of change in cM-iT connectivity induced by active versus sham rTMS.||||<0.0001
72473621|NCT04325282|144471277|OTHER|Given the multiple ROIs investigated, we adjusted significance thresholds using principal component analysis, which accounts for the effective number of independent tests. This method is suitable when data in each comparison are not completely independent, as is the case with EEG where signal represents summated activity from multiple regions.||||||0.002||||||The threshold for statistical significance was p \< 0.0076.|Wilcoxon signed rank test|||Within-group analysis of change in iF-cM connectivity during active rTMS (post-rTMS versus pre-rTMS).||||0.002
72473622|NCT04325282|144471277|OTHER|Given the multiple ROIs investigated, we adjusted significance thresholds using principal component analysis, which accounts for the effective number of independent tests. This method is suitable when data in each comparison are not completely independent, as is the case with EEG where signal represents summated activity from multiple regions.||||||0.54||||||The threshold for statistical significance was p \< 0.0076.|Wilcoxon signed rank test|||Within-group analysis of change in iF-cM connectivity during sham rTMS (post-rTMS versus pre-rTMS).||||0.54
72473623|NCT04325282|144471277|OTHER|Given the multiple ROIs investigated, we adjusted significance thresholds using principal component analysis, which accounts for the effective number of independent tests. This method is suitable when data in each comparison are not completely independent, as is the case with EEG where signal represents summated activity from multiple regions.||||||0.007||||||The threshold for statistical significance was p \< 0.0071.|Wilcoxon signed rank test|||Between-group analysis of change in iF-cM connectivity induced by active versus sham rTMS.||||0.007
72473624|NCT04325282|144471277|OTHER|Given the multiple ROIs investigated, we adjusted significance thresholds using principal component analysis, which accounts for the effective number of independent tests. This method is suitable when data in each comparison are not completely independent, as is the case with EEG where signal represents summated activity from multiple regions.||||||0.002||||||The threshold for statistical significance was p \< 0.0076.|Wilcoxon signed rank test|||Within-group analysis of change in iF-iT connectivity during active rTMS (post-rTMS versus pre-rTMS).||||0.002
72473625|NCT04325282|144471277|OTHER|Given the multiple ROIs investigated, we adjusted significance thresholds using principal component analysis, which accounts for the effective number of independent tests. This method is suitable when data in each comparison are not completely independent, as is the case with EEG where signal represents summated activity from multiple regions.||||||0.32||||||The threshold for statistical significance was p \< 0.0076.|Wilcoxon signed rank test|||Within-group analysis of change in iF-iT connectivity during sham rTMS (post-rTMS versus pre-rTMS).||||0.32
72473626|NCT04325282|144471277|OTHER|Given the multiple ROIs investigated, we adjusted significance thresholds using principal component analysis, which accounts for the effective number of independent tests. This method is suitable when data in each comparison are not completely independent, as is the case with EEG where signal represents summated activity from multiple regions.||||||0.01||||||The threshold for statistical significance was p \< 0.0071.|Wilcoxon signed rank test|||Between-group analysis of change in iF-iT connectivity induced by active versus sham rTMS.||||0.01
72473627|NCT04325282|144471277|OTHER|Given the multiple ROIs investigated, we adjusted significance thresholds using principal component analysis, which accounts for the effective number of independent tests. This method is suitable when data in each comparison are not completely independent, as is the case with EEG where signal represents summated activity from multiple regions.||||||0.003||||||The threshold for statistical significance was p \< 0.0076.|Wilcoxon signed rank test|||Within-group analysis of change in iF-cF connectivity during active rTMS (post-rTMS versus pre-rTMS).||||0.003
72473628|NCT04325282|144471277|OTHER|Given the multiple ROIs investigated, we adjusted significance thresholds using principal component analysis, which accounts for the effective number of independent tests. This method is suitable when data in each comparison are not completely independent, as is the case with EEG where signal represents summated activity from multiple regions.||||||0.29||||||The threshold for statistical significance was p \< 0.0076.|Wilcoxon signed rank test|||Within-group analysis of change in iF-cF connectivity during sham rTMS (post-rTMS versus pre-rTMS).||||0.29
72473629|NCT04325282|144471277|OTHER|Given the multiple ROIs investigated, we adjusted significance thresholds using principal component analysis, which accounts for the effective number of independent tests. This method is suitable when data in each comparison are not completely independent, as is the case with EEG where signal represents summated activity from multiple regions.||||||0.02||||||The threshold for statistical significance was p \< 0.0071.|Wilcoxon signed rank test|||Between-group analysis of change in iF-cF connectivity induced by active versus sham rTMS.||||0.02
72565866|NCT02709486|144662726|SUPERIORITY||LS Mean Ratio|0.85|STANDARD_ERROR_OF_MEAN|0.13||0.3057|TWO_SIDED|95.0|0.63|1.16|||Negative binomial model|||Week 24: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.||1.16|0.63|0.3057
72565867|NCT02709486|144662726|SUPERIORITY||LS Mean Ratio|0.82|STANDARD_ERROR_OF_MEAN|0.13||0.2056|TWO_SIDED|95.0|0.61|1.11|||Negative binomial model|||Week 24: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.||1.11|0.61|0.2056
72565868|NCT02709486|144662728|SUPERIORITY||LS Mean Ratio|0.62|STANDARD_ERROR_OF_MEAN|0.15||0.0441|TWO_SIDED|95.0|0.39|0.99|||Negative binomial model|||Week 2: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.||0.99|0.39|0.0441
72473630|NCT04325282|144471277|OTHER|Given the multiple ROIs investigated, we adjusted significance thresholds using principal component analysis, which accounts for the effective number of independent tests. This method is suitable when data in each comparison are not completely independent, as is the case with EEG where signal represents summated activity from multiple regions.||||||0.003||||||The threshold for statistical significance was p \< 0.0076.|Wilcoxon signed rank test|||Within-group analysis of change in iM-cT connectivity during active rTMS (post-rTMS versus pre-rTMS).||||0.003
72473631|NCT04325282|144471277|OTHER|Given the multiple ROIs investigated, we adjusted significance thresholds using principal component analysis, which accounts for the effective number of independent tests. This method is suitable when data in each comparison are not completely independent, as is the case with EEG where signal represents summated activity from multiple regions.||||||0.66||||||The threshold for statistical significance was p \< 0.0076.|Wilcoxon signed rank test|||Within-group analysis of change in iM-cT connectivity during sham rTMS (post-rTMS versus pre-rTMS).||||0.66
72473632|NCT04325282|144471277|OTHER|Given the multiple ROIs investigated, we adjusted significance thresholds using principal component analysis, which accounts for the effective number of independent tests. This method is suitable when data in each comparison are not completely independent, as is the case with EEG where signal represents summated activity from multiple regions.||||||0.008||||||The threshold for statistical significance was p \< 0.0071.|Wilcoxon signed rank test|||Between-group analysis of change in iM-cT connectivity induced by active versus sham rTMS.||||0.008
72473633|NCT04325282|144471277|OTHER|Given the multiple ROIs investigated, we adjusted significance thresholds using principal component analysis, which accounts for the effective number of independent tests. This method is suitable when data in each comparison are not completely independent, as is the case with EEG where signal represents summated activity from multiple regions.||||||0.005||||||The threshold for statistical significance was p \< 0.0076.|Wilcoxon signed rank test|||Within-group analysis of change in iF-cT connectivity during active rTMS (post-rTMS versus pre-rTMS).||||0.005
72473634|NCT04325282|144471277|OTHER|Given the multiple ROIs investigated, we adjusted significance thresholds using principal component analysis, which accounts for the effective number of independent tests. This method is suitable when data in each comparison are not completely independent, as is the case with EEG where signal represents summated activity from multiple regions.||||||0.87||||||The threshold for statistical significance was p \< 0.0076.|Wilcoxon signed rank test|||Within-group analysis of change in iF-cT connectivity during sham rTMS (post-rTMS versus pre-rTMS).||||0.87
72473635|NCT04325282|144471277|OTHER|Given the multiple ROIs investigated, we adjusted significance thresholds using principal component analysis, which accounts for the effective number of independent tests. This method is suitable when data in each comparison are not completely independent, as is the case with EEG where signal represents summated activity from multiple regions.||||||0.11||||||The threshold for statistical significance was p \< 0.0071.|Wilcoxon signed rank test|||Between-group analysis of change in iF-cT connectivity induced by active versus sham rTMS.||||0.11
72507186|NCT03151148|144546491|SUPERIORITY||Geometric mean ratio (GMR)|33.86||||0.007|TWO_SIDED|95.0|2.672|429.219|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs. Non-lesional within Placebo at Day 4~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||429.219|2.672|0.007
72507187|NCT03151148|144546491|SUPERIORITY||Geometric mean ratio (GMR)|11.97||||0.055|TWO_SIDED|95.0|0.945|151.752|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs. Non-lesional within Placebo at Day 7~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||151.752|0.945|0.055
72507188|NCT03151148|144546491|SUPERIORITY||Geometric mean ratio (GMR)|0.93||||0.957|TWO_SIDED|95.0|0.062|13.875|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs. Non-lesional within Placebo at Day 8~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||13.875|0.062|0.957
72507189|NCT03151148|144546491|SUPERIORITY||Geometric mean ratio (GMR)|1.78||||0.654|TWO_SIDED|95.0|0.141|22.607|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs. Non-lesional within Placebo at Day 11~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||22.607|0.141|0.654
72473636|NCT04325282|144471277|OTHER|Given the multiple ROIs investigated, we adjusted significance thresholds using principal component analysis, which accounts for the effective number of independent tests. This method is suitable when data in each comparison are not completely independent, as is the case with EEG where signal represents summated activity from multiple regions.||||||0.012||||||The threshold for statistical significance was p \< 0.0076.|Wilcoxon signed rank test|||Within-group analysis of change in iF-iM connectivity during active rTMS (post-rTMS versus pre-rTMS).||||0.012
72473637|NCT04325282|144471277|OTHER|Given the multiple ROIs investigated, we adjusted significance thresholds using principal component analysis, which accounts for the effective number of independent tests. This method is suitable when data in each comparison are not completely independent, as is the case with EEG where signal represents summated activity from multiple regions.||||||0.46||||||The threshold for statistical significance was p \< 0.0076.|Wilcoxon signed rank test|||Within-group analysis of change in iF-iM connectivity during active rTMS (post-rTMS versus pre-rTMS).||||0.46
72473638|NCT04325282|144471277|OTHER|Given the multiple ROIs investigated, we adjusted significance thresholds using principal component analysis, which accounts for the effective number of independent tests. This method is suitable when data in each comparison are not completely independent, as is the case with EEG where signal represents summated activity from multiple regions.||||||0.02||||||The threshold for statistical significance was p \< 0.0071.|Wilcoxon signed rank test|||Between-group analysis of change in iF-iM connectivity induced by active versus sham rTMS.||||0.02
72473639|NCT04325282|144471277|OTHER|Given the multiple ROIs investigated, we adjusted significance thresholds using principal component analysis, which accounts for the effective number of independent tests. This method is suitable when data in each comparison are not completely independent, as is the case with EEG where signal represents summated activity from multiple regions.||||||0.01||||||The threshold for statistical significance was p \< 0.0076.|Wilcoxon signed rank test|||Within-group analysis of change in iT-cT connectivity during active rTMS (post-rTMS versus pre-rTMS).||||0.01
72473640|NCT04325282|144471277|OTHER|Given the multiple ROIs investigated, we adjusted significance thresholds using principal component analysis, which accounts for the effective number of independent tests. This method is suitable when data in each comparison are not completely independent, as is the case with EEG where signal represents summated activity from multiple regions.||||||0.99||||||The threshold for statistical significance was p \< 0.0076.|Wilcoxon signed rank test|||Within-group analysis of change in iT-cT connectivity during sham rTMS (post-rTMS versus pre-rTMS).||||0.99
72473641|NCT04325282|144471277|OTHER|Given the multiple ROIs investigated, we adjusted significance thresholds using principal component analysis, which accounts for the effective number of independent tests. This method is suitable when data in each comparison are not completely independent, as is the case with EEG where signal represents summated activity from multiple regions.||||||0.04||||||The threshold for statistical significance was p \< 0.0071.|Wilcoxon signed rank test|||Between-group analysis of change in iT-cT connectivity induced by active versus sham rTMS.||||0.04
72473642|NCT04325282|144471277|OTHER|Given the multiple ROIs investigated, we adjusted significance thresholds using principal component analysis, which accounts for the effective number of independent tests. This method is suitable when data in each comparison are not completely independent, as is the case with EEG where signal represents summated activity from multiple regions.||||||0.01||||||The threshold for statistical significance was p \< 0.0076.|Wilcoxon signed rank test|||Within-group analysis of change in cF-cT connectivity during active rTMS (post-rTMS versus pre-rTMS).||||0.01
72473643|NCT04325282|144471277|OTHER|Given the multiple ROIs investigated, we adjusted significance thresholds using principal component analysis, which accounts for the effective number of independent tests. This method is suitable when data in each comparison are not completely independent, as is the case with EEG where signal represents summated activity from multiple regions.||||||0.31||||||The threshold for statistical significance was p \< 0.0076.|Wilcoxon signed rank test|||Within-group analysis of change in cF-cT connectivity during sham rTMS (post-rTMS versus pre-rTMS).||||0.31
72473644|NCT04325282|144471277|OTHER|Given the multiple ROIs investigated, we adjusted significance thresholds using principal component analysis, which accounts for the effective number of independent tests. This method is suitable when data in each comparison are not completely independent, as is the case with EEG where signal represents summated activity from multiple regions.||||||0.05||||||The threshold for statistical significance was p \< 0.0071.|Wilcoxon signed rank test|||Between-group analysis of change in cF-cT connectivity induced by active versus sham rTMS.||||0.05
72473645|NCT04325282|144471277|OTHER|Given the multiple ROIs investigated, we adjusted significance thresholds using principal component analysis, which accounts for the effective number of independent tests. This method is suitable when data in each comparison are not completely independent, as is the case with EEG where signal represents summated activity from multiple regions.||||||0.03|||||||Wilcoxon signed rank test|The threshold for statistical significance was p \< 0.0076.||Within-group analysis of change in cF-cM connectivity during active rTMS (post-rTMS versus pre-rTMS).||||0.03
72473646|NCT04325282|144471277|OTHER|Given the multiple ROIs investigated, we adjusted significance thresholds using principal component analysis, which accounts for the effective number of independent tests. This method is suitable when data in each comparison are not completely independent, as is the case with EEG where signal represents summated activity from multiple regions.||||||0.2||||||The threshold for statistical significance was p \< 0.0076.|Wilcoxon signed rank test|||Within-group analysis of change in cF-cM connectivity during sham rTMS (post-rTMS versus pre-rTMS).||||0.20
72473647|NCT04325282|144471277|OTHER|Given the multiple ROIs investigated, we adjusted significance thresholds using principal component analysis, which accounts for the effective number of independent tests. This method is suitable when data in each comparison are not completely independent, as is the case with EEG where signal represents summated activity from multiple regions.||||||0.04||||||The threshold for statistical significance was p \< 0.0071.|Wilcoxon signed rank test|||Between-group analysis of change in cF-cM connectivity induced by active versus sham rTMS.||||0.04
72473648|NCT04325282|144471277|OTHER|Given the multiple ROIs investigated, we adjusted significance thresholds using principal component analysis, which accounts for the effective number of independent tests. This method is suitable when data in each comparison are not completely independent, as is the case with EEG where signal represents summated activity from multiple regions.||||||0.05||||||The threshold for statistical significance was p \< 0.0076.|Wilcoxon signed rank test|||Within-group analysis of change in cF-iM connectivity during active rTMS (post-rTMS versus pre-rTMS).||||0.05
72565869|NCT02709486|144662728|SUPERIORITY||LS Mean Ratio|0.73|STANDARD_ERROR_OF_MEAN|0.17||0.1895|TWO_SIDED|95.0|0.46|1.17|||Negative binomial model|||Week 2: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.||1.17|0.46|0.1895
72398289|NCT02157298|144302786|SUPERIORITY_OR_OTHER||Risk Difference (RD)|3.4|STANDARD_ERROR_OF_MEAN|3.769||0.3727|TWO_SIDED|95.0|-4.0|10.7||Significant at alpha=0.05 (two-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure|Regression, Logistic|Based on methodology of Zhang, Tsiatis \& Davidian and Tsitatis, Davidian, Zhang \& Lu, with adjustment with adjustment for baseline value and DPP-4||H0: proportion(dapa) minus proportion(placebo) = 0 versus alternative HA: proportion(dapa) minus proportion(placebo) =/= 0||10.7|-4.0|0.3727
72473649|NCT04325282|144471277|OTHER|Given the multiple ROIs investigated, we adjusted significance thresholds using principal component analysis, which accounts for the effective number of independent tests. This method is suitable when data in each comparison are not completely independent, as is the case with EEG where signal represents summated activity from multiple regions.||||||0.59||||||The threshold for statistical significance was p \< 0.0076.|Wilcoxon signed rank test|||Within-group analysis of change in cF-iM connectivity during sham rTMS (post-rTMS versus pre-rTMS).||||0.59
72473650|NCT04325282|144471277|OTHER|Given the multiple ROIs investigated, we adjusted significance thresholds using principal component analysis, which accounts for the effective number of independent tests. This method is suitable when data in each comparison are not completely independent, as is the case with EEG where signal represents summated activity from multiple regions.||||||0.12||||||The threshold for statistical significance was p \< 0.0071.|Wilcoxon signed rank test|||Between-group analysis of change in cF-iM connectivity induced by active versus sham rTMS.||||0.12
72473651|NCT04325282|144471277|OTHER|Given the multiple ROIs investigated, we adjusted significance thresholds using principal component analysis, which accounts for the effective number of independent tests. This method is suitable when data in each comparison are not completely independent, as is the case with EEG where signal represents summated activity from multiple regions.||||||0.1||||||The threshold for statistical significance was p \< 0.0076.|Wilcoxon signed rank test|||Within-group analysis of change in iM-iT connectivity during active rTMS (post-rTMS versus pre-rTMS).||||0.10
72473652|NCT04325282|144471277|OTHER|Given the multiple ROIs investigated, we adjusted significance thresholds using principal component analysis, which accounts for the effective number of independent tests. This method is suitable when data in each comparison are not completely independent, as is the case with EEG where signal represents summated activity from multiple regions.||||||0.57||||||The threshold for statistical significance was p \< 0.0076.|Wilcoxon signed rank test|||Within-group analysis of change in iM-iT connectivity during sham rTMS (post-rTMS versus pre-rTMS).||||0.57
72473653|NCT04325282|144471277|OTHER|Given the multiple ROIs investigated, we adjusted significance thresholds using principal component analysis, which accounts for the effective number of independent tests. This method is suitable when data in each comparison are not completely independent, as is the case with EEG where signal represents summated activity from multiple regions.||||||0.06||||||The threshold for statistical significance was p \< 0.0071.|Wilcoxon signed rank test|||Between-group analysis of change in iM-iT connectivity induced by active versus sham rTMS.||||0.06
72473654|NCT04325282|144471277|OTHER|Given the multiple ROIs investigated, we adjusted significance thresholds using principal component analysis, which accounts for the effective number of independent tests. This method is suitable when data in each comparison are not completely independent, as is the case with EEG where signal represents summated activity from multiple regions.||||||0.12||||||The threshold for statistical significance was p \< 0.0076.|Wilcoxon signed rank test|||Within-group analysis of change in cM-cT connectivity during active rTMS (post-rTMS versus pre-rTMS).||||0.12
72473655|NCT04325282|144471277|OTHER|Given the multiple ROIs investigated, we adjusted significance thresholds using principal component analysis, which accounts for the effective number of independent tests. This method is suitable when data in each comparison are not completely independent, as is the case with EEG where signal represents summated activity from multiple regions.||||||0.69||||||The threshold for statistical significance was p \< 0.0076.|Wilcoxon signed rank test|||Within-group analysis of change in cM-cT connectivity during sham rTMS (post-rTMS versus pre-rTMS).||||0.69
72473656|NCT04325282|144471277|OTHER|Given the multiple ROIs investigated, we adjusted significance thresholds using principal component analysis, which accounts for the effective number of independent tests. This method is suitable when data in each comparison are not completely independent, as is the case with EEG where signal represents summated activity from multiple regions.||||||0.14||||||The threshold for statistical significance was p \< 0.0071.|Wilcoxon signed rank test|||Between-group analysis of change in cM-cT connectivity induced by active versus sham rTMS.||||0.14
72507190|NCT03151148|144546493|SUPERIORITY||Geometric mean ratio (GMR)|2.722||||0.432|TWO_SIDED|95.0|0.2227|33.2594|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Change from baseline is based on the difference in log10 post-baseline and log10 baseline values. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs. Non-lesional within TMT at Day 0~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||33.2594|0.2227|0.432
72565870|NCT02709486|144662728|SUPERIORITY||LS Mean Ratio|0.6|STANDARD_ERROR_OF_MEAN|0.16||0.0567|TWO_SIDED|95.0|0.35|1.01|||Negative binomial model|||Week 4: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.||1.01|0.35|0.0567
72398290|NCT03171415|144302790|SUPERIORITY||||||>|0.05|TWO_SIDED|5.0|||||Kruskal-Wallis|||The Kruskal-Wallis T-test was applied for analyzing the difference in between the study groups||||>0.05
72398291|NCT03171415|144302790|SUPERIORITY||||||<|0.05|||||||Kruskal-Wallis|||The Kruskal-Wallis T-test was applied for analyzing the difference in between the study groups, at day 28 and Day 56||||<0.05
72398292|NCT03171415|144302790|SUPERIORITY||||||<|0.05|||||||Kruskal-Wallis|||The Kruskal-Wallis T-test was applied for analyzing the difference in between the study groups||||<0.05
72398293|NCT03171415|144302790|SUPERIORITY||||||<|0.05|||||||Kruskal-Wallis|||The Kruskal-Wallis T-test was applied for analyzing the difference in between the study groups||||<0.05
72398294|NCT03171415|144302791|SUPERIORITY||||||>|0.05|||||||t-test, 2 sided|||||||>0.05
72398295|NCT03171415|144302791|OTHER||||||>|0.05|||||||t-test, 2 sided|||||||>0.05
72507191|NCT03151148|144546493|SUPERIORITY||Geometric mean ratio (GMR)|0.147||||0.133|TWO_SIDED|95.0|0.0121|1.8018|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Change from baseline is based on the difference in log10 post-baseline and log10 baseline values. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs. Non-lesional within TMT at Day 4~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||1.8018|0.0121|0.133
72473657|NCT04325282|144471277|OTHER|Given the multiple ROIs investigated, we adjusted significance thresholds using principal component analysis, which accounts for the effective number of independent tests. This method is suitable when data in each comparison are not completely independent, as is the case with EEG where signal represents summated activity from multiple regions.||||||0.12||||||The threshold for statistical significance was p \< 0.0076.|Wilcoxon signed rank test|||Within-group analysis of change in iM-cM connectivity during active rTMS (post-rTMS versus pre-rTMS).||||0.12
72473658|NCT04325282|144471277|OTHER|Given the multiple ROIs investigated, we adjusted significance thresholds using principal component analysis, which accounts for the effective number of independent tests. This method is suitable when data in each comparison are not completely independent, as is the case with EEG where signal represents summated activity from multiple regions.||||||0.6||||||The threshold for statistical significance was p \< 0.0076.|Wilcoxon signed rank test|||Within-group analysis of change in iM-cM connectivity during sham rTMS (post-rTMS versus pre-rTMS).||||0.60
72507192|NCT03151148|144546493|SUPERIORITY||Geometric mean ratio (GMR)|0.371||||0.437|TWO_SIDED|95.0|0.0304|4.5392|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Change from baseline is based on the difference in log10 post-baseline and log10 baseline values. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs. Non-lesional within TMT at Day 7~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||4.5392|0.0304|0.437
72507193|NCT03151148|144546493|SUPERIORITY||Geometric mean ratio (GMR)|1.247||||0.863|TWO_SIDED|95.0|0.1002|15.5231|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Change from baseline is based on the difference in log10 post-baseline and log10 baseline values. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs. Non-lesional within TMT at Day 8~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||15.5231|0.1002|0.863
72507194|NCT03151148|144546493|SUPERIORITY||Geometric mean ratio (GMR)|0.615||||0.702|TWO_SIDED|95.0|0.0503|7.5106|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Change from baseline is based on the difference in log10 post-baseline and log10 baseline values. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs. Non-lesional within TMT at Day 11~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||7.5106|0.0503|0.702
72542450|NCT00106028|144614669|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.554||||0.0808||95.0|-0.193|3.301|||ANCOVA|LS means and p-value are from ANCOVA model adjusted by baseline and with fixed effects for age group, treatment and pooled center for post-baseline.||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.||3.301|-0.193|0.0808
72473659|NCT04325282|144471277|OTHER|Given the multiple ROIs investigated, we adjusted significance thresholds using principal component analysis, which accounts for the effective number of independent tests. This method is suitable when data in each comparison are not completely independent, as is the case with EEG where signal represents summated activity from multiple regions.||||||0.04||||||The threshold for statistical significance was p \< 0.0071.|Wilcoxon signed rank test|||Between-group analysis of change in iM-cM connectivity induced by active versus sham rTMS.||||0.04
72473660|NCT02672852|144471278|OTHER||Adjusted percentage difference|70.8|||<|0.001|TWO_SIDED|95.0|65.7|76.0|||Cochran-Mantel-Haenszel|||Across strata, P value was calculated from the Cochran-Mantel-Haenszel (CMH) test adjusted for strata. Within each stratum, P value was calculated based on the chi-square test (or Fisher's exact test if ≥25% of the cells had expected cell count \<5).||76.0|65.7|< 0.001
72473661|NCT02672852|144471279|OTHER||Adjusted percentage difference|76.5|||<|0.001|TWO_SIDED|95.0|70.4|82.5|||Cochran-Mantel-Haenszel|||Across strata, P value was calculated from the CMH test adjusted for strata. Within each stratum, P value was calculated based on the chi-square test (or Fisher's exact test if ≥25% of the cells had expected cell count \<5).||82.5|70.4|< 0.001
72473662|NCT02672852|144471280|OTHER||Adjusted percentage difference|25.9|||<|0.001|TWO_SIDED|95.0|17.3|34.6|||Cochran-Mantel-Haenszel|||Across strata, P value was calculated from the CMH test adjusted for strata. Within each stratum, P value was calculated based on the chi-square test (or Fisher's exact test if ≥25% of the cells had expected cell count \<5).||34.6|17.3|< 0.001
72398296|NCT03171415|144302791|OTHER||||||>|0.05|||||||t-test, 2 sided|||||||>0.05
72473663|NCT02672852|144471281|OTHER||Adjusted percentage difference|80.6|||<|0.001|TWO_SIDED|95.0|74.5|86.6|||Cochran-Mantel-Haenszel|||Across strata, P value was calculated from the CMH test adjusted for strata. Within each stratum, P value was calculated based on the chi-square test (or Fisher's exact test if ≥25% of the cells had expected cell count \<5).||86.6|74.5|< 0.001
72473664|NCT02672852|144471282|OTHER||Adjusted percentage difference|45.5|||<|0.001|TWO_SIDED|95.0|40.3|50.8|||Cochran-Mantel-Haenszel|||Across strata, P value was calculated from the CMH test adjusted for strata. Within each stratum, P value was calculated based on the chi-square test (or Fisher's exact test if ≥25% of the cells had expected cell count \<5).||50.8|40.3|< 0.001
72473665|NCT02672852|144471283|OTHER||Adjusted percentage difference|44.8|||<|0.001|TWO_SIDED|95.0|39.5|50.0|||Cochran-Mantel-Haenszel|||Across strata, P value was calculated from the CMH test adjusted for strata. Within each stratum, P value was calculated based on the chi-square test (or Fisher's exact test if ≥25% of the cells had expected cell count \<5).||50.0|39.5|< 0.001
72473666|NCT02672852|144471284|OTHER||Adjusted percentage difference|62.1|||<|0.001|TWO_SIDED|95.0|56.4|67.9|||Cochran-Mantel-Haenszel|||Across strata, P value was calculated from the CMH test adjusted for strata. Within each stratum, P value was calculated based on the chi-square test (or Fisher's exact test if ≥25% of the cells had expected cell count \<5).||67.9|56.4|< 0.001
72473667|NCT02672852|144471285|OTHER||Adjusted percentage difference|73.9|||<|0.001|TWO_SIDED|95.0|66.0|81.9|||Cochran-Mantel-Haenszel|||Across strata, P value was calculated from the CMH test adjusted for strata. Within each stratum, P value was calculated based on the chi-square test (or Fisher's exact test if ≥25% of the cells had expected cell count \<5).||81.9|66.0|< 0.001
72473668|NCT02672852|144471286|OTHER||Adjusted percentage difference|21.2|||<|0.001|TWO_SIDED|95.0|13.7|28.7|||Cochran-Mantel-Haenszel|||Across strata, P value was calculated from the CMH test adjusted for strata. Within each stratum, P value was calculated based on the chi-square test (or Fisher's exact test if ≥25% of the cells had expected cell count \<5).||28.7|13.7|< 0.001
72623083|NCT05472870|144776475|SUPERIORITY|One-way ANOVA with repeated measures was used to examine differences in the effects of cTMS on the SRS. A P value \<0.05 was considered statistically significant for all analyses.|||||<|0.001||||||Bonferroni correction was used to adjust P values in post hoc analyses.|ANOVA|||All clinical behavioral data analysis was performed using Statistical Product and Service Solutions (SPSS) software (version 25.0). A P value \<0.05 was considered statistically significant for all analyses. One-way ANOVA with repeated measures was used to examine differences in the effects of cTMS on the SRS.||||<0.001
72473669|NCT02672852|144471287|OTHER||Adjusted percentage difference|33.1|||<|0.001|TWO_SIDED|95.0|24.0|42.2|||Cochran-Mantel-Haenszel|||Across strata, P value was calculated from the CMH test adjusted for strata. Within each stratum, P value was calculated based on the chi-square test (or Fisher's exact test if ≥25% of the cells had expected cell count \<5).||42.2|24.0|< 0.001
72473670|NCT02672852|144471288|OTHER||Adjusted percentage difference|33.7|||<|0.001|TWO_SIDED|95.0|23.2|44.2|||Cochran-Mantel-Haenszel|||Across strata, P value was calculated from the CMH test adjusted for strata. Within each stratum, P value was calculated based on the chi-square test (or Fisher's exact test if ≥25% of the cells had expected cell count \<5).||44.2|23.2|< 0.001
72473671|NCT02551653|144471310|OTHER||Mean Ratio|0.832|||||TWO_SIDED|95.0|0.682|0.979|||||||Volume of Distribution - Heart, Left Ventricular Wall: The mean ratio was calculated using the posterior distribution of the ratio of group means (PAH subjects to Healthy Volunteers). The 95% confidence interval is a 95% Bayesian credible interval based on the highest posterior density interval.|0.979|0.682|
72473672|NCT02551653|144471310|OTHER||Mean Ratio|1.472|||||TWO_SIDED|95.0|1.113|1.891|||||||Volume of Distribution - Heart, Right Ventricular Wall: The mean ratio was calculated using the posterior distribution of the ratio of group means (PAH subjects to Healthy Volunteers). The 95% confidence interval is a 95% Bayesian credible interval based on the highest posterior density interval.|1.891|1.113|
72473673|NCT02551653|144471310|OTHER||Mean Ratio|0.958|||||TWO_SIDED|95.0|0.692|1.241|||||||Volume of Distribution - Lung: The mean ratio was calculated using the posterior distribution of the ratio of group means (PAH subjects to Healthy Volunteers). The 95% confidence interval is a 95% Bayesian credible interval based on the highest posterior density interval.|1.241|0.692|
72473674|NCT02551653|144471311|OTHER||Mean Ratio|1.013|||||TWO_SIDED|95.0|0.846|1.189|||||||Mean Standardized Uptake Values - Heart, Left Ventricular Wall: The mean ratio was calculated using the posterior distribution of the ratio of group means (PAH subjects to Healthy Volunteers). The 95% confidence interval is a 95% Bayesian credible interval based on the highest posterior density interval.|1.189|0.846|
72473675|NCT02551653|144471311|OTHER||Mean Ratio|1.056|||||TWO_SIDED|95.0|0.853|1.269|||||||Mean Standardized Uptake Values - Heart, Right Ventricular Wall: The mean ratio was calculated using the posterior distribution of the ratio of group means (PAH subjects to Healthy Volunteers). The 95% confidence interval is a 95% Bayesian credible interval based on the highest posterior density interval.|1.269|0.853|
72473676|NCT02551653|144471311|OTHER||Mean Ratio|1.047|||||TWO_SIDED|95.0|0.786|1.34|||||||Mean Standardized Uptake Values - Lung: The mean ratio was calculated using the posterior distribution of the ratio of group means (PAH subjects to Healthy Volunteers). The 95% confidence interval is a 95% Bayesian credible interval based on the highest posterior density interval.|1.340|0.786|
72473677|NCT02683785|144471312|OTHER||Mean Difference (Net)|-0.36||||0.442|TWO_SIDED|95.0|-1.31|0.58||MMRM model with fixed effects of Baseline Value,Treatment Group,Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used.p-value corresponds to the difference over placebo measure and confidence interval|Mixed Model Repeated Measures Analysis||Difference from placebo for Week 6 is presented.|||0.58|-1.31|0.442
72542451|NCT00106028|144614670|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.498||||0.6466|TWO_SIDED|95.0|-1.648|2.644|||ANCOVA|LS means and p-value are from ANCOVA model adjusted by baseline and with fixed effects for age group, treatment and pooled center for post-baseline.||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.||2.644|-1.648|0.6466
72398297|NCT03171415|144302791|OTHER||||||>|0.05|||||||t-test, 2 sided|||||||>0.05
72398298|NCT03171415|144302797|OTHER||||||>|0.05|||||||t-test, 2 sided|||||||>0.05
72473678|NCT02683785|144471313|OTHER||Mean Difference (Net)|-0.46||||0.046|TWO_SIDED|95.0|-0.9|-0.01||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||Difference from placebo for Week 1 is presented|||-0.01|-0.90|0.046
72473679|NCT02683785|144471313|OTHER||Mean Difference (Net)|-0.38||||0.257|TWO_SIDED|95.0|-1.05|0.29||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||Difference from placebo for Week 2 is presented|||0.29|-1.05|0.257
72507195|NCT03151148|144546493|SUPERIORITY||Geometric mean ratio (GMR)|0.465||||0.675|TWO_SIDED|95.0|0.0128|16.8576|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Change from baseline is based on the difference in log10 post-baseline and log10 baseline values. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs. Non-lesional within Placebo at Day 0~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||16.8576|0.0128|0.675
72473680|NCT02683785|144471313|OTHER||Mean Difference (Net)|-0.5||||0.22|TWO_SIDED|95.0|-1.31|0.31||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||Difference from placebo for Week 3 is presented|||0.31|-1.31|0.220
72473681|NCT02683785|144471313|OTHER||Mean Difference (Net)|-0.74||||0.085|TWO_SIDED|95.0|-1.59|0.11||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||Difference from placebo for Week 4 is presented|||0.11|-1.59|0.085
72473682|NCT02683785|144471313|OTHER||Mean Difference (Net)|-0.36||||0.442|TWO_SIDED|95.0|-1.31|0.58||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||Difference from placebo for Week 6 is presented|||0.58|-1.31|0.442
72473683|NCT02683785|144471313|OTHER||Mean Difference (Net)|-0.83||||0.139|TWO_SIDED|95.0|-1.93|0.28||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||Difference from placebo for Week 8 is presented|||0.28|-1.93|0.139
72473684|NCT02683785|144471313|OTHER||Mean Difference (Net)|-0.9||||0.103|TWO_SIDED|95.0|-2.0|0.19||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||Difference from placebo for Week 10 is presented|||0.19|-2.00|0.103
72473685|NCT02683785|144471313|OTHER||Mean Difference (Net)|-0.89||||0.132|TWO_SIDED|95.0|-2.06|0.28||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||Difference from placebo for Week 12 is presented.|||0.28|-2.06|0.132
72473686|NCT02683785|144471314|OTHER||Mean Difference (Net)|-0.45||||0.082|TWO_SIDED|95.0|-0.97|0.06||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||Difference from placebo for Week 1 is presented.|||0.06|-0.97|0.082
72473687|NCT02683785|144471314|OTHER||Mean Difference (Net)|-0.27||||0.426|TWO_SIDED|95.0|-0.96|0.41||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||Difference from placebo for Week 2 is presented|||0.41|-0.96|0.426
72473688|NCT02683785|144471314|OTHER||Mean Difference (Net)|-0.6||||0.129|TWO_SIDED|95.0|-1.38|0.18||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||Difference from placebo for Week 3 is presented|||0.18|-1.38|0.129
72473689|NCT02683785|144471314|OTHER||Mean Difference (Net)|-0.78||||0.067|TWO_SIDED|95.0|-1.63|0.06||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||Difference from placebo for Week 4 is presented.|||0.06|-1.63|0.067
72473690|NCT02683785|144471314|OTHER||Mean Difference (Net)|-0.33||||0.494|TWO_SIDED|95.0|-1.28|0.63||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||Difference from placebo for Week 6 is presented|||0.63|-1.28|0.494
72398299|NCT04059094|144302799|OTHER||Adjusted means difference|1.5|STANDARD_ERROR_OF_MEAN|2.45||0.5468|TWO_SIDED|95.0|-3.5|6.5|||Mixed model with repeated measurements||Adjusted means difference was calculated as value from BI 1265162 200μg minus value from placebo group.|Mixed Model for Repeated Measures (MMRM) with fixed effects for baseline, visit, treatment, treatment-by-visit interaction, baseline-by-visit interaction, and random effect for patient was applied. No hypothesis testing was performed, as this trial was prematurely discontinued. MMRM only included data from 200µg BI and placebo, as the sample size of the BI 20µg, BI 50µg and BI 100µg dose levels was limited because of the premature discontinuation of the trial.||6.5|-3.5|0.5468
72398300|NCT04059094|144302800|OTHER||Adjuste means difference|2.1|STANDARD_ERROR_OF_MEAN|1.83||0.3039|TWO_SIDED|95.0|-2.4|6.5|||ANCOVA||Adjusted means difference was calculated as value from BI 1265162 200μg minus value from placebo group.|ANCOVA based on analysis of covariance with fixed effects for baseline and treatment was applied. Statistical analysis was performed for 200μg BI and placebo groups only. No hypothesis testing was performed, as this trial was prematurely discontinued. ANCOVA only included data from 200µg BI and placebo, as the sample size of the BI 20µg, BI 50µg and BI 100µg dose levels was limited because of the premature discontinuation of the trial.||6.5|-2.4|0.3039
72398301|NCT01338493|144302818|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
72398302|NCT01338493|144302819|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
72398303|NCT02625259|144302833|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.36|||||TWO_SIDED|90.0|1.0|1.83||||||Analysis of variance was performed for calculating 90 percent (%) confidence intervals (CIs) for the ratios of log-transformed geometric mean Cmax of TAK-117 tablet versus capsule dosage form.||1.83|1.00|
72565871|NCT02709486|144662728|SUPERIORITY||LS Mean Ratio|0.75|STANDARD_ERROR_OF_MEAN|0.2||0.296|TWO_SIDED|95.0|0.44|1.28|||Negative binomial model|||Week 4: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.||1.28|0.44|0.2960
72398304|NCT02625259|144302833|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.2|||||TWO_SIDED|90.0|0.86|1.67||||||Analysis of variance was performed for calculating 90% CIs for the ratios of log-transformed geometric mean Cmax of TAK-117 tablet dosage form with food versus without food.||1.67|0.86|
72398305|NCT02625259|144302833|SUPERIORITY_OR_OTHER||Geometric mean ratio|0.03|||||TWO_SIDED|90.0|0.02|0.07||||||Analysis of variance was performed for calculating 90% CIs for the ratios of log-transformed geometric mean Cmax of TAK-117 tablet dosage form with lansoprazole versus a single dose of TAK-117 alone.||0.07|0.02|
72398306|NCT02625259|144302835|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.47|||||TWO_SIDED|90.0|0.98|2.18||||||Analysis of variance was performed for calculating 90 % CIs for the ratios of log-transformed geometric mean AUClast of TAK-117 tablet versus capsule dosage form.||2.18|0.98|
72398307|NCT02625259|144302835|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.76|||||TWO_SIDED|90.0|1.11|2.78||||||Analysis of variance was performed for calculating 90% CIs for the ratios of log-transformed geometric mean AUClast of TAK-117 tablet dosage form with food versus without food.||2.78|1.11|
72398308|NCT02625259|144302835|SUPERIORITY_OR_OTHER||Geometric mean ratio|0.02|||||TWO_SIDED|90.0|0.01|0.04||||||Analysis of variance was performed for calculating 90% CIs for the ratios of log-transformed geometric mean AUClast of TAK-117 tablet dosage form with lansoprazole versus a single dose of TAK-117 alone.||0.04|0.01|
72398309|NCT02625259|144302836|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.53|||||TWO_SIDED|90.0|0.93|2.51||||||Analysis of variance was performed for calculating 90 % CIs for the ratios of log-transformed geometric mean AUC∞ of TAK-117 tablet versus capsule dosage form.||2.51|0.93|
72398310|NCT02625259|144302836|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.5|||||TWO_SIDED|90.0|1.0|2.25||||||Analysis of variance was performed for calculating 90% CIs for the ratios of log-transformed geometric mean AUC∞ of TAK-117 tablet dosage form with food versus without food.||2.25|1.00|
72398311|NCT02625259|144302836|SUPERIORITY_OR_OTHER||Geometric mean ratio|0.08|||||TWO_SIDED|90.0|0.03|0.18||||||Analysis of variance was performed for calculating 90% CIs for the ratios of log-transformed geometric mean AUC∞ of TAK-117 tablet dosage form with lansoprazole versus a single dose of TAK-117 alone.||0.18|0.03|
72398312|NCT00513474|144302838|SUPERIORITY|||||||0.036|||||||Gray's test for competing risks|||||||.036
72398313|NCT01662908|144302987|OTHER||Mean Difference (Final Values)|8.8|STANDARD_ERROR_OF_MEAN|10.74|||TWO_SIDED|95.0|-12.7|30.2||||||||30.2|-12.7|
72398314|NCT00786487|144303001|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||t-test, 2 sided|||||||<0.05
72398315|NCT00786487|144303001|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||t-test, 2 sided|||||||<0.05
72565872|NCT02709486|144662728|SUPERIORITY||LS Mean Ratio|0.65|STANDARD_ERROR_OF_MEAN|0.18||0.1215|TWO_SIDED|95.0|0.37|1.12|||Negative binomial model|||Week 8: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.||1.12|0.37|0.1215
72398316|NCT00412854|144303008|NON_INFERIORITY_OR_EQUIVALENCE|The upper limit of the standardized asymptotic 95% confidence interval (CI) on the group difference \[Infanrix+Hiberix Group minus Infanrix/Hib Group\] in percentage of seroprotected subjects was ≤ 10%.|Difference in seroprotection rate|0.61|||||TWO_SIDED|95.0|-1.68|3.39||||||"Difference in seroprotection rates against diphteria toxoid:~To demonstrate that the immunogenicity of Infanrix™/Hib vaccine administered at 3, 4 and 5 months of age (Infanrix/Hib Group) was non-inferior to that of the concomitant administration of Infanrix™ and Hiberix™ vaccines at the same age (Infanrix+Hiberix Group), in terms of immune response to all vaccine antigens, one month after the three-dose primary vaccination course."||3.39|-1.68|
72398317|NCT00412854|144303008|NON_INFERIORITY_OR_EQUIVALENCE|The upper limit of the standardized asymptotic 95% confidence interval (CI) on the group difference \[Infanrix+Hiberix Group minus Infanrix/Hib Group\] in percentage of seroprotected subjects was ≤ 10%.|Difference in seroprotection rate|0.0|||||TWO_SIDED|95.0|-2.29|2.3||||||"Difference in seroprotection rates against tetanus toxoid:~To demonstrate that the immunogenicity of Infanrix™/Hib vaccine administered at 3, 4 and 5 months of age (Infanrix/Hib Group) was non-inferior to that of the concomitant administration of Infanrix™ and Hiberix™ vaccines at the same age (Infanrix+Hiberix Group), in terms of immune response to all vaccine antigens, one month after the three-dose vaccination course."||2.30|-2.29|
72473691|NCT02683785|144471314|OTHER||Mean Difference (Net)|-0.94||||0.107|TWO_SIDED|95.0|-2.08|0.21||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||Difference from placebo for Week 8 is presented.|||0.21|-2.08|0.107
72473692|NCT02683785|144471314|OTHER||Mean Difference (Net)|-0.98||||0.092|TWO_SIDED|95.0|-2.13|0.17||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||Difference from placebo for Week 10 is presented.|||0.17|-2.13|0.092
72473693|NCT02683785|144471314|OTHER||Mean Difference (Net)|-1.01||||0.098|TWO_SIDED|95.0|-2.22|0.2||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||Difference from placebo for Week 12 is presented.|||0.20|-2.22|0.098
72473694|NCT02683785|144471319|OTHER||Mean Difference (Net)|-2.8||||0.061|TWO_SIDED|95.0|-5.6|0.1||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval|Mixed Model Repeated Measures Analysis||For Pain component, Week 1|||0.1|-5.6|0.061
72507196|NCT03151148|144546493|SUPERIORITY||Geometric mean ratio (GMR)|32.638||||0.057|TWO_SIDED|95.0|0.8994|1184.4298|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Change from baseline is based on the difference in log10 post-baseline and log10 baseline values. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs. Non-lesional within Placebo at Day 4~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||1184.4298|0.8994|0.057
72507197|NCT03151148|144546493|SUPERIORITY||Geometric mean ratio (GMR)|11.539||||0.181|TWO_SIDED|95.0|0.318|418.7586|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Change from baseline is based on the difference in log10 post-baseline and log10 baseline values. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs. Non-lesional within Placebo at Day 7~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||418.7586|0.3180|0.181
72507198|NCT03151148|144546493|SUPERIORITY||Geometric mean ratio (GMR)|0.895||||0.953|TWO_SIDED|95.0|0.0219|36.5559|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Change from baseline is based on the difference in log10 post-baseline and log10 baseline values. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs. Non-lesional within Placebo at Day 8~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||36.5559|0.0219|0.953
72507199|NCT03151148|144546493|SUPERIORITY||Geometric mean ratio (GMR)|1.719||||0.767|TWO_SIDED|95.0|0.0474|62.3828|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Change from baseline is based on the difference in log10 post-baseline and log10 baseline values. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs. Non-lesional within Placebo at Day 11~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||62.3828|0.0474|0.767
72507200|NCT03151148|144546495|SUPERIORITY||Geometric mean ratio (GMR)|1.395||||0.488|TWO_SIDED|95.0|0.5429|3.5835|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Change from baseline is based on the difference in log10 post-baseline and log10 baseline values. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs. Non-lesional within TMT at Day 0~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||3.5835|0.5429|0.488
72473695|NCT02683785|144471319|OTHER||Mean Difference (Net)|-2.0||||0.282|TWO_SIDED|95.0|-5.6|1.7||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||For Pain component, Week 2|||1.7|-5.6|0.282
72473696|NCT02683785|144471319|OTHER||Mean Difference (Net)|-3.7||||0.113|TWO_SIDED|95.0|-8.4|0.9||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval|Mixed Model Repeated Measures Analysis||For Pain component Week 4|||0.9|-8.4|0.113
72473697|NCT02683785|144471319|OTHER||Mean Difference (Net)|-1.0||||0.695|TWO_SIDED|95.0|-5.9|4.0||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval|Mixed Model Repeated Measures Analysis||For Pain component, Week 6|||4.0|-5.9|0.695
72473698|NCT02683785|144471319|OTHER||Mean Difference (Net)|-3.8||||0.176|TWO_SIDED|95.0|-9.4|1.8||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval|Mixed Model Repeated Measures Analysis||For Pain component, Week 8|||1.8|-9.4|0.176
72507201|NCT03151148|144546495|SUPERIORITY||Geometric mean ratio (GMR)|2.823||||0.03|TWO_SIDED|95.0|1.1038|7.221|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Change from baseline is based on the difference in log10 post-baseline and log10 baseline values. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs. Non-lesional within TMT at Day 4~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||7.2210|1.1038|0.030
72507202|NCT03151148|144546495|SUPERIORITY||Geometric mean ratio (GMR)|2.077||||0.127|TWO_SIDED|95.0|0.8122|5.3135|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Change from baseline is based on the difference in log10 post-baseline and log10 baseline values. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs. Non-lesional within TMT at Day 7~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||5.3135|0.8122|0.127
72473699|NCT02683785|144471319|OTHER||Mean Difference (Net)|-5.5||||0.041|TWO_SIDED|95.0|-10.8|-0.2||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval|Mixed Model Repeated Measures Analysis||For Pain component, Week 10|||-0.2|-10.8|0.041
72473700|NCT02683785|144471319|OTHER||Mean Difference (Net)|-4.7||||0.082|TWO_SIDED|95.0|-10.1|0.6||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval|Mixed Model Repeated Measures Analysis||For Pain component, Week 12|||0.6|-10.1|0.082
72473701|NCT02683785|144471319|OTHER||Mean Difference (Net)|-0.2||||0.587|TWO_SIDED|95.0|-1.1|0.6||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval|Mixed Model Repeated Measures Analysis||For Stiffness component, Week 1|||0.6|-1.1|0.587
72473702|NCT02683785|144471319|OTHER||Mean Difference (Net)|-0.4||||0.457|TWO_SIDED|95.0|-1.3|0.6||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval|Mixed Model Repeated Measures Analysis||For Stiffness component, Week 2|||0.6|-1.3|0.457
72473703|NCT02683785|144471319|OTHER||Mean Difference (Net)|-0.6||||0.298|TWO_SIDED|95.0|-1.8|0.6||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval|Mixed Model Repeated Measures Analysis||For Stiffness component, Week 4|||0.6|-1.8|0.298
72473704|NCT02683785|144471319|OTHER||Mean Difference (Net)|-0.2||||0.726|TWO_SIDED|95.0|-1.3|0.9||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||For Stiffness component, Week 6|||0.9|-1.3|0.726
72473705|NCT02683785|144471319|OTHER||Mean Difference (Net)|-0.7||||0.213|TWO_SIDED|95.0|-1.9|0.4||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||For Stiffness component, Week 8|||0.4|-1.9|0.213
72473706|NCT02683785|144471319|OTHER||Mean Difference (Net)|-0.6||||0.331|TWO_SIDED|95.0|-1.9|0.7||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||For Stiffness component, Week 10|||0.7|-1.9|0.331
72473707|NCT02683785|144471319|OTHER||Mean Difference (Net)|-0.8||||0.248|TWO_SIDED|95.0|-2.1|0.6||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||For Stiffness component, Week 12|||0.6|-2.1|0.248
72473708|NCT02683785|144471319|OTHER||Mean Difference (Net)|-2.9||||0.35|TWO_SIDED|95.0|-9.0|3.3||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||For Physical Function component, Week 1|||3.3|-9.0|0.350
72507203|NCT03151148|144546495|SUPERIORITY||Geometric mean ratio (GMR)|0.789||||0.623|TWO_SIDED|95.0|0.3065|2.0331|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Change from baseline is based on the difference in log10 post-baseline and log10 baseline values. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs. Non-lesional within TMT at Day 8~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||2.0331|0.3065|0.623
72473709|NCT02683785|144471319|OTHER||Mean Difference (Net)|-3.0||||0.383|TWO_SIDED|95.0|-9.8|3.8||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||For Physical Function component, Week 2|||3.8|-9.8|0.383
72473710|NCT02683785|144471319|OTHER||Mean Difference (Net)|-4.8||||0.271|TWO_SIDED|95.0|-13.5|3.9||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||For Physical Function component, Week 4|||3.9|-13.5|0.271
72473711|NCT02683785|144471319|OTHER||Mean Difference (Net)|-2.7||||0.565|TWO_SIDED|95.0|-12.1|6.7||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval|Mixed Model Repeated Measures Analysis||For Physical Function component, Week 6|||6.7|-12.1|0.565
72507204|NCT03151148|144546495|SUPERIORITY||Geometric mean ratio (GMR)|0.627||||0.328|TWO_SIDED|95.0|0.245|1.6028|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Change from baseline is based on the difference in log10 post-baseline and log10 baseline values. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs. Non-lesional within TMT at Day 11~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||1.6028|0.2450|0.328
72507205|NCT03151148|144546495|SUPERIORITY||Geometric mean ratio (GMR)|2.231||||0.242|TWO_SIDED|95.0|0.5799|8.5866|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Change from baseline is based on the difference in log10 post-baseline and log10 baseline values. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs. Non-lesional within Placebo at Day 0~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||8.5866|0.5799|0.242
72565873|NCT02709486|144662728|SUPERIORITY||LS Mean Ratio|0.77|STANDARD_ERROR_OF_MEAN|0.22||0.3569|TWO_SIDED|95.0|0.44|1.34|||Negative binomial model|||Week 8: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.||1.34|0.44|0.3569
72473712|NCT02683785|144471319|OTHER||Mean Difference (Net)|-4.9||||0.343|TWO_SIDED|95.0|-15.2|5.4||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||For Physical Function component, Week 8|||5.4|-15.2|0.343
72473713|NCT02683785|144471319|OTHER||Mean Difference (Net)|-6.2||||0.266|TWO_SIDED|95.0|-17.3|4.9||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||For Physical Function component, Week 10|||4.9|-17.3|0.266
72473714|NCT02683785|144471319|OTHER||Mean Difference (Net)|-8.2||||0.136|TWO_SIDED|95.0|-19.1|2.7||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||For Physical Function component, Week 12|||2.7|-19.1|0.136
72473715|NCT02683785|144471319|OTHER||Mean Difference (Net)|-5.5||||0.23|TWO_SIDED|95.0|-14.5|3.6||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||For Total of all component scores, Week 1|||3.6|-14.5|0.230
72473716|NCT02683785|144471319|OTHER||Mean Difference (Net)|-4.6||||0.381|TWO_SIDED|95.0|-15.2|5.9||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||For Total of all component scores, Week 2|||5.9|-15.2|0.381
72473717|NCT02683785|144471319|OTHER||Mean Difference (Net)|-8.7||||0.207|TWO_SIDED|95.0|-22.4|5.0||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||For Total of all component scores, Week 4|||5.0|-22.4|0.207
72473718|NCT02683785|144471319|OTHER||Mean Difference (Net)|-3.4||||0.648|TWO_SIDED|95.0|-18.4|11.6||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||For Total of all component scores, Week 6|||11.6|-18.4|0.648
72473719|NCT02683785|144471319|OTHER||Mean Difference (Net)|-9.0||||0.278|TWO_SIDED|95.0|-25.4|7.5||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||For Total of all component scores, Week 8|||7.5|-25.4|0.278
72473720|NCT02683785|144471319|OTHER||Mean Difference (Net)|-12.1||||0.16|TWO_SIDED|95.0|-29.1|5.0||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||For Total of all component scores, Week 10|||5.0|-29.1|0.160
72473721|NCT02683785|144471319|OTHER||Mean Difference (Net)|-13.3||||0.127|TWO_SIDED|95.0|-30.5|3.9||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||For Total of all component scores, Week 12|||3.9|-30.5|0.127
72473722|NCT02683785|144471320|OTHER||Mean Difference (Net)|0.0||||0.957|TWO_SIDED|95.0|-1.9|1.8||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||Difference from placebo for Week 1 is presented|||1.8|-1.9|0.957
72473723|NCT02683785|144471320|OTHER||Mean Difference (Net)|0.3||||0.775|TWO_SIDED|95.0|-2.1|2.8||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||Difference from placebo for Week 2 is presented|||2.8|-2.1|0.775
72473724|NCT02683785|144471320|OTHER||Mean Difference (Net)|-0.5||||0.624|TWO_SIDED|95.0|-2.7|1.7||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||Difference from placebo for Week 4 is presented|||1.7|-2.7|0.624
72473725|NCT02683785|144471320|OTHER||Mean Difference (Net)|1.4||||0.243|TWO_SIDED|95.0|-1.0|3.8||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||Difference from placebo for Week 6 is presented|||3.8|-1.0|0.243
72473726|NCT02683785|144471320|OTHER||Mean Difference (Net)|0.2||||0.875|TWO_SIDED|95.0|-2.5|2.9||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||Difference from placebo for Week 8 is presented|||2.9|-2.5|0.875
72473727|NCT02683785|144471320|OTHER||Mean Difference (Net)|-0.3||||0.848|TWO_SIDED|95.0|-3.4|2.8||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||Difference from placebo for Week 10 is presented|||2.8|-3.4|0.848
72473728|NCT02683785|144471320|OTHER||Mean Difference (Net)|-0.2||||0.883|TWO_SIDED|95.0|-2.8|2.4||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||Difference from placebo for Week 12 is presented|||2.4|-2.8|0.883
72507206|NCT03151148|144546495|SUPERIORITY||Geometric mean ratio (GMR)|1.977||||0.321|TWO_SIDED|95.0|0.5137|7.6055|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Change from baseline is based on the difference in log10 post-baseline and log10 baseline values. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs. Non-lesional within Placebo at Day 4~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||7.6055|0.5137|0.321
72507207|NCT03151148|144546495|SUPERIORITY||Geometric mean ratio (GMR)|1.86||||0.366|TWO_SIDED|95.0|0.4833|7.1564|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Change from baseline is based on the difference in log10 post-baseline and log10 baseline values. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs. Non-lesional within Placebo at Day 7~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||7.1564|0.4833|0.366
72473729|NCT02683785|144471321|OTHER||Mean Difference (Net)|-1.2||||0.463|TWO_SIDED|95.0|-4.4|2.0||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||Difference from placebo for Week 1 is presented|||2.0|-4.4|0.463
72473730|NCT02683785|144471321|OTHER||Mean Difference (Net)|-0.4||||0.809|TWO_SIDED|95.0|-3.7|2.9||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||Difference from placebo for Week 2 is presented|||2.9|-3.7|0.809
72565874|NCT02709486|144662728|SUPERIORITY||LS Mean Ratio|0.67|STANDARD_ERROR_OF_MEAN|0.21||0.2096|TWO_SIDED|95.0|0.36|1.25|||Negative binomial model|||Week 12: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.||1.25|0.36|0.2096
72473731|NCT02683785|144471321|OTHER||Mean Difference (Net)|-1.9||||0.324|TWO_SIDED|95.0|-5.8|2.0||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||Difference from placebo for Week 4 is presented|||2.0|-5.8|0.324
72473732|NCT02683785|144471321|OTHER||Mean Difference (Net)|-0.5||||0.783|TWO_SIDED|95.0|-4.2|3.2||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||Difference from placebo for Week 6 is presented|||3.2|-4.2|0.783
72398318|NCT00412854|144303009|NON_INFERIORITY_OR_EQUIVALENCE|The upper limit of the standardized asymptotic 95% confidence interval (CI) on the group difference \[Infanrix+Hiberix Group minus Infanrix/Hib Group\] in percentage of seroprotected subjects was ≤ 10%.|Difference in seroprotection rate|2.47|||||TWO_SIDED|95.0|0.15|6.18||||||"Difference in seroprotection rates against PRP:~To demonstrate that the immunogenicity of Infanrix™/Hib vaccine administered at 3, 4 and 5 months of age (Infanrix/Hib Group) was non-inferior to that of the concomitant administration of Infanrix™ and Hiberix™ vaccines at the same age (Infanrix+Hiberix Group), in terms of immune response to all vaccine antigens, one month after the three-dose vaccination course."||6.18|0.15|
72473733|NCT02683785|144471321|OTHER||Mean Difference (Net)|-1.4||||0.464|TWO_SIDED|95.0|-5.4|2.5||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||Difference from placebo for Week 8 is presented|||2.5|-5.4|0.464
72473734|NCT02683785|144471321|OTHER||Mean Difference (Net)|-0.7||||0.736|TWO_SIDED|95.0|-4.9|3.5||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||Difference from placebo for Week 10 is presented|||3.5|-4.9|0.736
72507208|NCT03151148|144546495|SUPERIORITY||Geometric mean ratio (GMR)|3.713||||0.068|TWO_SIDED|95.0|0.908|15.1856|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Change from baseline is based on the difference in log10 post-baseline and log10 baseline values. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs. Non-lesional within Placebo at Day 8~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||15.1856|0.9080|0.068
72473735|NCT02683785|144471321|OTHER||Mean Difference (Net)|-0.5||||0.806|TWO_SIDED|95.0|-4.8|3.7||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||Difference from placebo for Week 12 is presented|||3.7|-4.8|0.806
72473736|NCT02683785|144471322|OTHER||Mean Difference (Net)|0.3||||0.586|TWO_SIDED|95.0|-0.9|1.6||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||Difference from placebo for Week 2 is presented|||1.6|-0.9|0.586
72473737|NCT02683785|144471322|OTHER||Mean Difference (Net)|-0.5||||0.416|TWO_SIDED|95.0|-1.9|0.8||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||Difference from placebo for Week 4 is presented|||0.8|-1.9|0.416
72473738|NCT02683785|144471322|OTHER||Mean Difference (Net)|-1.2||||0.12|TWO_SIDED|95.0|-2.8|0.3||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||Difference from placebo for Week 8 is presented|||0.3|-2.8|0.120
72507209|NCT03151148|144546495|SUPERIORITY||Geometric mean ratio (GMR)|2.858||||0.13|TWO_SIDED|95.0|0.7328|11.1434|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Change from baseline is based on the difference in log10 post-baseline and log10 baseline values. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs. Non-lesional within Placebo at Day 11~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||11.1434|0.7328|0.130
72507210|NCT03151148|144546496|SUPERIORITY||Geometric mean ratio (GMR)|3.16||||0.233|TWO_SIDED|95.0|0.476|20.952|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator.|"TMT vs Placebo on Lesional Skin at Day 0~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||20.952|0.476|0.233
72542452|NCT00106028|144614671|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.465||||0.7391|TWO_SIDED|95.0|-3.224|2.294|||ANCOVA|LS means and p-value are from ANCOVA model adjusted by baseline and with fixed effects for age group, treatment and pooled center for post-baseline.||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.||2.294|-3.224|0.7391
72473739|NCT02683785|144471322|OTHER||Mean Difference (Net)|-0.3||||0.687|TWO_SIDED|95.0|-2.1|1.4||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||Difference from placebo for Week 12 is presented|||1.4|-2.1|0.687
72473740|NCT02683785|144471323|OTHER||Mean Difference (Net)|-0.2||||0.651|TWO_SIDED|95.0|-1.3|0.8||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||Difference from placebo for Week 2 is presented.|||0.8|-1.3|0.651
72473741|NCT02683785|144471323|OTHER||Mean Difference (Net)|-0.7||||0.271|TWO_SIDED|95.0|-1.9|0.5||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||Difference from placebo for Week 4 is presented|||0.5|-1.9|0.271
72473742|NCT02683785|144471323|OTHER||Mean Difference (Net)|-0.9||||0.186|TWO_SIDED|95.0|-2.2|0.4||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||Difference from placebo for Week 8 is presented|||0.4|-2.2|0.186
72473743|NCT02683785|144471323|OTHER||Mean Difference (Net)|-1.1||||0.109|TWO_SIDED|95.0|-2.4|0.2||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||Difference from placebo for Week 12 is presented|||0.2|-2.4|0.109
72473744|NCT01346072|144471338|SUPERIORITY|||||||0.853|||||||Wilcoxon Two-Sample Test|Wilcoxon Two Sample Test was used with Exact Test two sided p value reported||||||0.853
72473745|NCT01346072|144471339|SUPERIORITY|||||||0.035|||||||Wilcoxon Two-Sample Test|Wilcoxon Two Sample Test was used with Exact Test two sided p value reported||||||0.035
72473746|NCT02233803|144471340|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority (NI) is demonstrated as the lower limit of CI for the difference is greater than the pre-specified NI margin of -1.25ML. The lower limit of the 95% CI for the treatment difference (NEUMOTEROL 400 -Symbicort Forte) was greater than the pre-specified non-inferiority margin of -1.25 mL.|Difference of LS means|0.044|||||TWO_SIDED|95.0|-0.008|0.096||||||Sample size calculations are based on the primary efficacy endpoint (change from baseline in trough FEV1 at day 29). Assuming a within-subject standard deviation of 210 mL, 168 completed subjects are required to demonstrate the non-inferiority of BFF 400/12 mcg SINGLE CAPSULE INHALER and BFF 320/9 mcg TURBUHALER BID, assuming a true difference of -50 mL with 90% power and a 2.5% one-sided significance level. The pre-specified NI margin is set at -1.25mL.||0.096|-0.008|
72473747|NCT02233803|144471341|SUPERIORITY_OR_OTHER||Difference of LS means|0.98|||||TWO_SIDED|95.0|0.576|1.384||||||||1.384|0.576|
72507211|NCT03151148|144546496|SUPERIORITY||Geometric mean ratio (GMR)|0.08||||0.008|TWO_SIDED|95.0|0.012|0.514|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator.|"TMT vs Placebo on Lesional Skin at Day 4~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||0.514|0.012|0.008
72507212|NCT03151148|144546496|SUPERIORITY||Geometric mean ratio (GMR)|0.04||||0.001|TWO_SIDED|95.0|0.007|0.298|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator.|"TMT vs Placebo on Lesional Skin at Day 7~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||0.298|0.007|0.001
72623084|NCT01385995|144776485|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.3||||0.57|TWO_SIDED|95.0|0.52|3.24|||Generalized Estimating Equation|Controlled for period and baseline 2 hour OGTT glucose level.||Based on an intent to treat approach a Generalized Estimating Equation (GEE) was used to estimate the effect of therapy (CPAP or Sham) on the odds of normalization of Impaired Glucose Tolerance (IGT). This model provides an estimate of the odds ratio of normalizing the 2-hour oral glucose tolerance test (OGTT) with CPAP compared with Sham-CPAP.||3.24|0.52|0.57
72473748|NCT02233803|144471342|SUPERIORITY_OR_OTHER||Difference of LS means|0.6|||||TWO_SIDED|95.0|0.1|1.1||||||||1.1|0.1|
72507213|NCT03151148|144546496|SUPERIORITY||Geometric mean ratio (GMR)|0.09||||0.017|TWO_SIDED|95.0|0.013|0.651|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator.|"TMT vs Placebo on Lesional Skin at Day 8~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||0.651|0.013|0.017
72623085|NCT01385995|144776486|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.9||||0.38|TWO_SIDED|95.0|-1.2|3.0|||Regression, Linear|Adjusted for period, baseline level of the outcome variable, BMI, Apnea-Hypopnea Index (AHI), gender and race.||Based on an intent-to-treat approach, a linear mixed effect model was used to estimate the association between therapy and measures of glucose indices, in this case fasting glucose, between CPAP and sham-CPAP.||3.0|-1.2|0.38
72473749|NCT03635099|144471343|OTHER||Risk Difference (RD)|5.0||||0.3091|TWO_SIDED|95.0|-1.8|11.8|||Chi-squared||Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).|||11.8|-1.8|0.3091
72473750|NCT03635099|144471343|OTHER||Risk Difference (RD)|7.7||||0.203|TWO_SIDED|95.0|-0.7|16.1|||Chi-squared||Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).|||16.1|-0.7|0.2030
72473751|NCT03635099|144471343|OTHER||Risk Difference (RD)|10.3||||0.138|TWO_SIDED|95.0|0.7|19.8|||Chi-squared||Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).|||19.8|0.7|0.1380
72473752|NCT03635099|144471343|OTHER||Risk Difference (RD)|30.0||||0.0062|TWO_SIDED|95.0|15.8|44.2|||Chi-squared||Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).|||44.2|15.8|0.0062
72507214|NCT03151148|144546496|SUPERIORITY||Geometric mean ratio (GMR)|0.04||||0.001|TWO_SIDED|95.0|0.007|0.292|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator.|"TMT vs Placebo on Lesional Skin at Day 11~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||0.292|0.007|0.001
72507215|NCT03151148|144546496|SUPERIORITY||Geometric mean ratio (GMR)|2.42||||0.358|TWO_SIDED|95.0|0.366|15.967|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator.|"TMT vs Placebo on Non-lesional Skin at Day 0~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||15.967|0.366|0.358
72507216|NCT03151148|144546496|SUPERIORITY||Geometric mean ratio (GMR)|0.1||||0.019|TWO_SIDED|95.0|0.016|0.683|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator.|"TMT vs Placebo on Non-lesional Skin at Day 4~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||0.683|0.016|0.019
72507217|NCT03151148|144546496|SUPERIORITY||Geometric mean ratio (GMR)|0.11||||0.023|TWO_SIDED|95.0|0.017|0.739|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator.|"TMT vs Placebo on Non-lesional Skin at Day 7~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||0.739|0.017|0.023
72507218|NCT03151148|144546496|SUPERIORITY||Geometric mean ratio (GMR)|0.09||||0.017|TWO_SIDED|95.0|0.013|0.647|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator.|"TMT vs Placebo on Non-lesional Skin at Day 8~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||0.647|0.013|0.017
72507219|NCT03151148|144546496|SUPERIORITY||Geometric mean ratio (GMR)|0.37||||0.299|TWO_SIDED|95.0|0.056|2.436|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator.|"TMT vs Placebo on Non-lesional Skin at Day 11~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||2.436|0.056|0.299
72507220|NCT03151148|144546497|SUPERIORITY||Geometric mean ratio (GMR)|1.49||||0.538|TWO_SIDED|95.0|0.415|5.38|||Mixed Models Analysis|||"TMT vs Placebo on Lesional Skin at Day 0~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."|All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator.|5.380|0.415|0.538
72507221|NCT03151148|144546497|SUPERIORITY||Geometric mean ratio (GMR)|0.88||||0.849|TWO_SIDED|95.0|0.245|3.18|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator.|"TMT vs Placebo on Lesional Skin at Day 4~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||3.180|0.245|0.849
72507222|NCT03151148|144546497|SUPERIORITY||Geometric mean ratio (GMR)|0.4||||0.155|TWO_SIDED|95.0|0.11|1.424|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator.|"TMT vs Placebo on Lesional Skin at Day 7~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||1.424|0.110|0.155
72565875|NCT02709486|144662728|SUPERIORITY||LS Mean Ratio|0.69|STANDARD_ERROR_OF_MEAN|0.22||0.2387|TWO_SIDED|95.0|0.37|1.28|||Negative binomial model|||Week 12: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.||1.28|0.37|0.2387
72565876|NCT02709486|144662728|SUPERIORITY||LS Mean Ratio|0.71|STANDARD_ERROR_OF_MEAN|0.22||0.2627|TWO_SIDED|95.0|0.39|1.29|||Negative binomial model|||Week 16: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.||1.29|0.39|0.2627
72473753|NCT03635099|144471343|OTHER||Risk Difference (RD)|25.6|||||TWO_SIDED|95.0|12.5|38.6|||||Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).|The 95% confidence interval for the unadjusted absolute difference in proportion (%) between active group and placebo group was estimated by Chi-square method. As pre-specified, no hypothesis testing was carried out for Part 2 of this trial and no p-values were provided.||38.6|12.5|
72473754|NCT03635099|144471343|OTHER||Risk Difference (RD)|23.8|||||TWO_SIDED|95.0|10.9|36.7|||||Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).|The 95% confidence interval for the unadjusted absolute difference in proportion (%) between active group and placebo group was estimated by Chi-square method. As pre-specified, no hypothesis testing was carried out for Part 2 of this trial and no p-values were provided.||36.7|10.9|
72473755|NCT03635099|144471343|OTHER|First the response rate of PASI 75 at week 12 for each dosage group was estimated by a logistic regression model including the fixed effect of treatment (categorical dose) and baseline PASI score as covariate was performed. The dose-response relationships were then tested using the Multiple Comparison Procedures and Modelling (MCP-Mod) approach based on the estimates from logistic regression.||||||0.0004||||||The multiple comparison procedure was implemented using optimal contrast tests which control the family-wise type I error rate at one-sided α = 0.05.|MCPMod Linear model fit.|||||||0.0004
72473756|NCT03635099|144471343|OTHER|First the response rate of PASI 75 at week 12 for each dosage group was estimated by a logistic regression model including the fixed effect of treatment (categorical dose) and baseline PASI score as covariate was performed. The dose-response relationships were then tested using the Multiple Comparison Procedures and Modelling (MCP-Mod) approach based on the estimates from logistic regression.||||||0.0012||||||The multiple comparison procedure was implemented using optimal contrast tests which control the family-wise type I error rate at one-sided α = 0.05.|MCPMod Logistic model fit.|Model assumption: 10% of the maximum effect is achieved at 25 mg and 80% of the maximum effect is achieved at 100 mg.||||||0.0012
72473757|NCT03635099|144471343|OTHER|First the response rate of PASI 75 at week 12 for each dosage group was estimated by a logistic regression model including the fixed effect of treatment (categorical dose) and baseline PASI score as covariate was performed. The dose-response relationships were then tested using the Multiple Comparison Procedures and Modelling (MCP-Mod) approach based on the estimates from logistic regression.||||||0.0008||||||The multiple comparison procedure was implemented using optimal contrast tests which control the family-wise type I error rate at one-sided α = 0.05.|MCPMod Emax1 model fit.|Model assumption: 30% of the maximum effect is achieved at 50 mg.||||||0.0008
72473758|NCT03635099|144471343|OTHER|First the response rate of PASI 75 at week 12 for each dosage group was estimated by a logistic regression model including the fixed effect of treatment (categorical dose) and baseline PASI score as covariate was performed. The dose-response relationships were then tested using the Multiple Comparison Procedures and Modelling (MCP-Mod) approach based on the estimates from logistic regression.||||||0.0217||||||The multiple comparison procedure was implemented using optimal contrast tests which control the family-wise type I error rate at one-sided α = 0.05.|MCPMod Emax2 model fit.|Model assumption: 80% of the maximum effect is achieved at 50 mg.||||||0.0217
72473759|NCT03635099|144471343|OTHER|First the response rate of PASI 75 at week 12 for each dosage group was estimated by a logistic regression model including the fixed effect of treatment (categorical dose) and baseline PASI score as covariate was performed. The dose-response relationships were then tested using the Multiple Comparison Procedures and Modelling (MCP-Mod) approach based on the estimates from logistic regression.||||||0.0004||||||The multiple comparison procedure was implemented using optimal contrast tests which control the family-wise type I error rate at one-sided α = 0.05.|MCPMod Exponential model fit.|Model assumption: 5% of the maximum effect is achieved at 25 mg.||||||0.0004
72473760|NCT03635099|144471344|OTHER||Risk Difference (RD)|2.5||||0.4758|TWO_SIDED|95.0|-2.3|7.3|||Chi-squared||Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).|||7.3|-2.3|0.4758
72473761|NCT03635099|144471344|OTHER||Risk Difference (RD)|7.7||||0.203|TWO_SIDED|95.0|-0.7|16.1|||Chi-squared||Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).|||16.1|-0.7|0.2030
72473762|NCT03635099|144471344|OTHER||Risk Difference (RD)|5.1||||0.3028|TWO_SIDED|95.0|-1.8|12.1|||Chi-squared||Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).|||12.1|-1.8|0.3028
72473763|NCT03635099|144471344|OTHER||Risk Difference (RD)|27.5||||0.0095|TWO_SIDED|95.0|13.7|41.3|||Chi-squared||Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).|||41.3|13.7|0.0095
72473764|NCT03635099|144471344|OTHER|First the response rate of sPGA 0/1 at week 12 for each dosage group was estimated by a logistic regression model including the fixed effect of treatment (categorical dose) and baseline sPGA score as covariate was performed. The dose-response relationships were then tested using the Multiple Comparison Procedures and Modelling (MCP-Mod) approach based on the estimates from logistic regression.||||||0.0007||||||The multiple comparison procedure was implemented using optimal contrast tests which control the family-wise type I error rate at one-sided α = 0.05.|MCPMod Linear model fit.|||||||0.0007
72473765|NCT03635099|144471344|OTHER|First the response rate of sPGA 0/1 at week 12 for each dosage group was estimated by a logistic regression model including the fixed effect of treatment (categorical dose) and baseline sPGA score as covariate was performed. The dose-response relationships were then tested using the Multiple Comparison Procedures and Modelling (MCP-Mod) approach based on the estimates from logistic regression.||||||0.0023||||||The multiple comparison procedure was implemented using optimal contrast tests which control the family-wise type I error rate at one-sided α = 0.05.|MCPMod Logistic model fit.|Model assumption: 10% of the maximum effect is achieved at 25 mg and 80% of the maximum effect is achieved at 100 mg.||||||0.0023
72473766|NCT03635099|144471344|OTHER|First the response rate of sPGA 0/1 at week 12 for each dosage group was estimated by a logistic regression model including the fixed effect of treatment (categorical dose) and baseline sPGA score as covariate was performed. The dose-response relationships were then tested using the Multiple Comparison Procedures and Modelling (MCP-Mod) approach based on the estimates from logistic regression.||||||0.0018||||||The multiple comparison procedure was implemented using optimal contrast tests which control the family-wise type I error rate at one-sided α = 0.05.|MCPMod Emax1 model fit.|Model assumption: 30% of the maximum effect is achieved at 50 mg.||||||0.0018
72473767|NCT03635099|144471344|OTHER|First the response rate of sPGA 0/1 at week 12 for each dosage group was estimated by a logistic regression model including the fixed effect of treatment (categorical dose) and baseline sPGA score as covariate was performed. The dose-response relationships were then tested using the Multiple Comparison Procedures and Modelling (MCP-Mod) approach based on the estimates from logistic regression.||||||0.0386||||||The multiple comparison procedure was implemented using optimal contrast tests which control the family-wise type I error rate at one-sided α = 0.05.|MCPMod Emax2 model fit.|Model assumption: 80% of the maximum effect is achieved at 50 mg.||||||0.0386
72473768|NCT03635099|144471344|OTHER|First the response rate of sPGA 0/1 at week 12 for each dosage group was estimated by a logistic regression model including the fixed effect of treatment (categorical dose) and baseline sPGA score as covariate was performed. The dose-response relationships were then tested using the Multiple Comparison Procedures and Modelling (MCP-Mod) approach based on the estimates from logistic regression.||||||0.0004||||||The multiple comparison procedure was implemented using optimal contrast tests which control the family-wise type I error rate at one-sided α = 0.05.|MCPMod Exponential model fit.|Model assumption: 5% of the maximum effect is achieved at 25 mg.||||||0.0004
72473769|NCT03635099|144471345|OTHER||Risk Difference (RD)|0.0||||1|TWO_SIDED|95.0|-11.7|11.7|||Chi-squared||Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).|||11.7|-11.7|1.0000
72473770|NCT03635099|144471345|OTHER||Risk Difference (RD)|20.6||||0.054|TWO_SIDED|95.0|3.9|37.3|||Chi-squared||Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).|||37.3|3.9|0.0540
72473771|NCT03635099|144471345|OTHER||Risk Difference (RD)|15.5||||0.1167|TWO_SIDED|95.0|-0.4|31.4|||Chi-squared||Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).|||31.4|-0.4|0.1167
72473772|NCT03635099|144471345|OTHER||Risk Difference (RD)|45.0||||0.0006|TWO_SIDED|95.0|26.8|63.2|||Chi-squared||Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).|||63.2|26.8|0.0006
72473773|NCT03635099|144471345|OTHER||Risk Difference (RD)|45.8|||||TWO_SIDED|95.0|22.0|69.6|||||Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).|The 95% confidence interval for the unadjusted absolute difference in proportion (%) between active group and placebo group was estimated by Chi-square method. As pre-specified, no hypothesis testing was carried out for Part 2 of this trial and no p-values were provided.||69.6|22.0|
72473774|NCT03635099|144471345|OTHER||Risk Difference (RD)|35.2|||||TWO_SIDED|95.0|11.3|59.2|||||Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).|The 95% confidence interval for the unadjusted absolute difference in proportion (%) between active group and placebo group was estimated by Chi-square method. As pre-specified, no hypothesis testing was carried out for Part 2 of this trial and no p-values were provided.||59.2|11.3|
72473775|NCT03635099|144471346|OTHER||Risk Difference (RD)|5.1||||0.3028|TWO_SIDED|95.0|-1.8|12.1|||Chi-squared||Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).|||12.1|-1.8|0.3028
72473776|NCT03635099|144471346|OTHER||Risk Difference (RD)|2.6||||0.4701|TWO_SIDED|95.0|-2.4|7.5|||Chi-squared||Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).|||7.5|-2.4|0.4701
72473777|NCT03635099|144471346|OTHER||Risk Difference (RD)|17.5||||0.0465|TWO_SIDED|95.0|5.7|29.3|||Chi-squared||Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).|||29.3|5.7|0.0465
72473778|NCT03635099|144471346|OTHER||Risk Difference (RD)|9.3|||||TWO_SIDED|95.0|0.6|18.0|||||Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).|The 95% confidence interval for the unadjusted absolute difference in proportion (%) between active group and placebo group was estimated by Chi-square method. As pre-specified, no hypothesis testing was carried out for Part 2 of this trial and no p-values were provided.||18.0|0.6|
72473779|NCT03635099|144471346|OTHER||Risk Difference (RD)|4.8|||||TWO_SIDED|95.0|-1.7|11.2|||||Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).|The 95% confidence interval for the unadjusted absolute difference in proportion (%) between active group and placebo group was estimated by Chi-square method. As pre-specified, no hypothesis testing was carried out for Part 2 of this trial and no p-values were provided.||11.2|-1.7|
72473780|NCT03635099|144471347|OTHER||Risk Difference (RD)|2.6||||0.4701|TWO_SIDED|95.0|-2.4|7.5|||Chi-squared||Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).|||7.5|-2.4|0.4701
72473781|NCT03635099|144471347|OTHER||Risk Difference (RD)|5.0||||0.3091|TWO_SIDED|95.0|-1.8|11.8|||Chi-squared||Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).|||11.8|-1.8|0.3091
72473782|NCT03635099|144471347|OTHER||Risk Difference (RD)|2.3|||||TWO_SIDED|95.0|-2.2|6.8|||||Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).|The 95% confidence interval for the unadjusted absolute difference in proportion (%) between active group and placebo group was estimated by Chi-square method. As pre-specified, no hypothesis testing was carried out for Part 2 of this trial and no p-values were provided.||6.8|-2.2|
72473783|NCT03635099|144471347|OTHER||Risk Difference (RD)|2.4|||||TWO_SIDED|95.0|-2.2|7.0|||||Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).|The 95% confidence interval for the unadjusted absolute difference in proportion (%) between active group and placebo group was estimated by Chi-square method. As pre-specified, no hypothesis testing was carried out for Part 2 of this trial and no p-values were provided.||7.0|-2.2|
72473784|NCT03635099|144471348|OTHER||Risk Difference (RD)|2.5||||0.4758|TWO_SIDED|95.0|-2.3|7.3|||Chi-squared||Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).|||7.3|-2.3|0.4758
72565877|NCT02709486|144662728|SUPERIORITY||LS Mean Ratio|0.72|STANDARD_ERROR_OF_MEAN|0.22||0.2863|TWO_SIDED|95.0|0.4|1.31|||Negative binomial model|||Week 16: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group||1.31|0.40|0.2863
72565878|NCT02709486|144662728|SUPERIORITY||LS Mean Ratio|0.82|STANDARD_ERROR_OF_MEAN|0.27||0.556|TWO_SIDED|95.0|0.43|1.58|||Negative binomial model|||Week 24: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.||1.58|0.43|0.5560
72473785|NCT03635099|144471348|OTHER||Risk Difference (RD)|2.6||||0.4701|TWO_SIDED|95.0|-2.4|7.5|||Chi-squared||Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).|||7.5|-2.4|0.4701
72473786|NCT03635099|144471348|OTHER||Risk Difference (RD)|12.8||||0.0942|TWO_SIDED|95.0|2.3|23.3|||Chi-squared||Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).|||23.3|2.3|0.0942
72473787|NCT03635099|144471348|OTHER||Risk Difference (RD)|27.5||||0.0095|TWO_SIDED|95.0|13.7|41.3|||Chi-squared||Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).|||41.3|13.7|0.0095
72473788|NCT03635099|144471348|OTHER||Risk Difference (RD)|5.0||||0.3091|TWO_SIDED|95.0|-1.8|11.8|||Chi-squared||Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).|||11.8|-1.8|0.3091
72473789|NCT03635099|144471348|OTHER||Risk Difference (RD)|7.7||||0.203|TWO_SIDED|95.0|-0.7|16.1|||Chi-squared||Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).|||16.1|-0.7|0.2030
72473790|NCT03635099|144471348|OTHER||Risk Difference (RD)|10.3||||0.138|TWO_SIDED|95.0|0.7|19.8|||Chi-squared||Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).|||19.8|0.7|0.1380
72473791|NCT03635099|144471348|OTHER||Risk Difference (RD)|32.5||||0.004|TWO_SIDED|95.0|18.0|47.0|||Chi-squared||Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).|||47.0|18.0|0.0040
72473792|NCT03635099|144471348|OTHER||Risk Difference (RD)|10.3||||0.138|TWO_SIDED|95.0|0.7|19.8|||Chi-squared||Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).|||19.8|0.7|0.1380
72473793|NCT03635099|144471348|OTHER||Risk Difference (RD)|35.0||||0.0025|TWO_SIDED|95.0|20.2|49.8|||Chi-squared||Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).|||49.8|20.2|0.0025
72473794|NCT03635099|144471349|OTHER||Risk Difference (RD)|2.6||||0.4701|TWO_SIDED|95.0|-2.4|7.5|||Chi-squared||Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).|||7.5|-2.4|0.4701
72473795|NCT03635099|144471349|OTHER||Risk Difference (RD)|5.0||||0.3091|TWO_SIDED|95.0|-1.8|11.8|||Chi-squared||Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).|||11.8|-1.8|0.3091
72473796|NCT03635099|144471350|OTHER||Risk Difference (RD)|2.5||||0.4758|TWO_SIDED|95.0|-2.3|7.3|||Chi-squared||Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).|||7.3|-2.3|0.4758
72473797|NCT03635099|144471350|OTHER||Risk Difference (RD)|5.1||||0.3028|TWO_SIDED|95.0|-1.8|12.1|||Chi-squared||Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).|||12.1|-1.8|0.3028
72473798|NCT03635099|144471350|OTHER||Risk Difference (RD)|7.7||||0.203|TWO_SIDED|95.0|-0.7|16.1|||Chi-squared||Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).|||16.1|-0.7|0.2030
72473799|NCT03635099|144471350|OTHER||Risk Difference (RD)|30.0||||0.0062|TWO_SIDED|95.0|15.8|44.2|||Chi-squared||Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).|||44.2|15.8|0.0062
72473800|NCT03635099|144471350|OTHER||Risk Difference (RD)|10.3||||0.138|TWO_SIDED|95.0|0.7|19.8|||Chi-squared||Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).|||19.8|0.7|0.1380
72473801|NCT03635099|144471350|OTHER||Risk Difference (RD)|5.1||||0.3028|TWO_SIDED|95.0|-1.8|12.1|||Chi-squared||Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).|||12.1|-1.8|0.3028
72473802|NCT03635099|144471350|OTHER||Risk Difference (RD)|25.0||||0.0143|TWO_SIDED|95.0|11.6|38.4|||Chi-squared||Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).|||38.4|11.6|0.0143
72473803|NCT03635099|144471350|OTHER||Risk Difference (RD)|7.7||||0.203|TWO_SIDED|95.0|-0.7|16.1|||Chi-squared||Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).|||16.1|-0.7|0.2030
72473804|NCT03635099|144471350|OTHER||Risk Difference (RD)|10.3||||0.138|TWO_SIDED|95.0|0.7|19.8|||Chi-squared||Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).|||19.8|0.7|0.1380
72473805|NCT03635099|144471350|OTHER||Risk Difference (RD)|32.5||||0.004|TWO_SIDED|95.0|18.0|47.0|||Chi-squared||Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).|||47.0|18.0|0.0040
72473806|NCT03635099|144471351|OTHER||Adjusted mean|0.5|STANDARD_ERROR_OF_MEAN|1.2||0.7008|TWO_SIDED|95.0|-1.9|2.8|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|MMRM model included treatment, visit and treatment by visit as fixed effects, baseline PSS score and baseline PSS by visit as covariates, patient as a random effect, and an unstructured covariance structure for within patient variation.|||2.8|-1.9|0.7008
72473807|NCT03635099|144471351|OTHER||Adjusted mean|0.6|STANDARD_ERROR_OF_MEAN|1.2||0.6268|TWO_SIDED|95.0|-1.8|3.0|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|MMRM model included treatment, visit and treatment by visit as fixed effects, baseline PSS score and baseline PSS by visit as covariates, patient as a random effect, and an unstructured covariance structure for within patient variation.|||3.0|-1.8|0.6268
72473808|NCT03635099|144471351|OTHER||Adjusted mean|2.7|STANDARD_ERROR_OF_MEAN|1.2||0.0266|TWO_SIDED|95.0|0.3|5.1|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|MMRM model included treatment, visit and treatment by visit as fixed effects, baseline PSS score and baseline PSS by visit as covariates, patient as a random effect, and an unstructured covariance structure for within patient variation.|||5.1|0.3|0.0266
72473809|NCT03635099|144471351|OTHER||Adjusted mean|4.0|STANDARD_ERROR_OF_MEAN|1.2||0.0009|TWO_SIDED|95.0|1.7|6.3|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|MMRM model included treatment, visit and treatment by visit as fixed effects, baseline PSS score and baseline PSS by visit as covariates, patient as a random effect, and an unstructured covariance structure for within patient variation.|||6.3|1.7|0.0009
72473810|NCT03635099|144471351|OTHER||Adjusted mean|3.1|STANDARD_ERROR_OF_MEAN|1.4|||TWO_SIDED|95.0|0.4|5.8|||||MMRM model included treatment, visit and treatment by visit as fixed effects, baseline PSS score and baseline PSS by visit as covariates, patient as a random effect, and an unstructured covariance structure for within patient variation.|||5.8|0.4|
72473811|NCT03635099|144471351|OTHER||Adjusted mean|3.1|STANDARD_ERROR_OF_MEAN|1.4|||TWO_SIDED|95.0|0.4|5.8|||||MMRM model included treatment, visit and treatment by visit as fixed effects, baseline PSS score and baseline PSS by visit as covariates, patient as a random effect, and an unstructured covariance structure for within patient variation.|||5.8|0.4|
72473812|NCT03635099|144471352|OTHER||Risk Difference (RD)|2.5||||0.7144|TWO_SIDED|95.0|-10.1|15.1|||Chi-squared||Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).|||15.1|-10.1|0.7144
72473813|NCT03635099|144471352|OTHER||Risk Difference (RD)|2.7||||0.697|TWO_SIDED|95.0|-10.0|15.4|||Chi-squared||Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).|||15.4|-10.0|0.6970
72473814|NCT03635099|144471352|OTHER||Risk Difference (RD)|2.7||||0.697|TWO_SIDED|95.0|-10.0|15.4|||Chi-squared||Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).|||15.4|-10.0|0.6970
72473815|NCT03635099|144471352|OTHER||Risk Difference (RD)|15.0||||0.125|TWO_SIDED|95.0|-0.6|30.6|||Chi-squared||Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).|||30.6|-0.6|0.1250
72473816|NCT03635099|144471352|OTHER||Risk Difference (RD)|7.9|||||TWO_SIDED|95.0|-20.3|36.1|||||Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).|The 95% confidence interval for the unadjusted absolute difference in proportion (%) between active group and placebo group was estimated by Chi-square method. As pre-specified, no hypothesis testing was carried out for Part 2 of this trial and no p-values were provided.||36.1|-20.3|
72473817|NCT03635099|144471352|OTHER||Risk Difference (RD)|6.2|||||TWO_SIDED|95.0|-21.9|34.3|||||Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).|The 95% confidence interval for the unadjusted absolute difference in proportion (%) between active group and placebo group was estimated by Chi-square method. As pre-specified, no hypothesis testing was carried out for Part 2 of this trial and no p-values were provided.||34.3|-21.9|
72473818|NCT01840410|144471403|SUPERIORITY_OR_OTHER||Mean Difference (Net)|9.94|STANDARD_ERROR_OF_MEAN|1.502|<|0.001|TWO_SIDED|95.0|6.97|12.91|||Mixed Models Analysis|||||12.91|6.97|<0.001
72623086|NCT01385995|144776486|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.3||||0.11|TWO_SIDED|95.0|-16.3|1.7|||Regression, Linear|Adjusted for period, baseline level of the outcome variable, BMI, AHI, gender and race.||Based on an intent-to-treat approach, a linear mixed effect model was used to estimate the association between measures of glucose indices, in this case, 2 hour OGTT, and therapeutic CPAP vs. Sham.||1.7|-16.3|0.11
72473819|NCT00798434|144471468|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.54|STANDARD_ERROR_OF_MEAN|0.29|<|0.0001|TWO_SIDED|95.0|-2.12|-0.97|||ANCOVA|Covariates were treatment, study center, dosing time, age category, and baseline urgency episodes.||Based on a 2-sided t-test (5% significance). Null hypothesis: no difference in mean change in mean micturition-related urgency episodes per 24 hours at Week 12 for the 2 groups. Last observation carried forward (LOCF) method used for statistical analyses of the FAS (change from baseline to Week 12).||-0.97|-2.12|<0.0001
72473820|NCT00798434|144471469|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-14.44|||<|0.0001|TWO_SIDED|95.0|-14.67|-14.25|||2-sided Van Elteren's test||Hodges-Lehman estimate of median treatment difference and confidence interval (CI)|Week 12 LOCF||-14.25|-14.67|<0.0001
72473821|NCT00798434|144471470|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.85|STANDARD_ERROR_OF_MEAN|0.22||0.0001|TWO_SIDED|95.0|-1.28|-0.42|||ANCOVA|Covariates were treatment, study center, dosing time, age category, and baseline severe urgency episodes||Week 12 LOCF||-0.42|-1.28|0.0001
72473822|NCT00798434|144471471|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.0005|TWO_SIDED|95.0|0.0|0.0|||2-sided Van Elteren's test||Hodges-Lehman estimate of median treatment difference and CI|Week 12 LOCF||0.00|0.00|0.0005
72473823|NCT00798434|144471472|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.98|STANDARD_ERROR_OF_MEAN|0.18|<|0.0001|TWO_SIDED|95.0|-1.33|-0.64|||ANCOVA|Covariates were treatment, study center, dosing time, age category, and baseline number of micturitions||Week 12 LOCF||-0.64|-1.33|<0.0001
72473824|NCT00798434|144471473|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-7.31|||<|0.0001|TWO_SIDED|95.0|-7.4|-7.19|||2-sided Van Elteren's test|||Week 12 LOCF||-7.19|-7.40|<0.0001
72565879|NCT02709486|144662728|SUPERIORITY||LS Mean Ratio|0.8|STANDARD_ERROR_OF_MEAN|0.26||0.5076|TWO_SIDED|95.0|0.42|1.53|||Negative binomial model|||Week 24: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.||1.53|0.42|0.5076
72473825|NCT00798434|144471474|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.24|STANDARD_ERROR_OF_MEAN|0.08||0.0026|TWO_SIDED|95.0|-0.4|-0.09|||ANCOVA|Covariates were treatment, study center, dosing time, age category, and baseline number of night-time micturitions||Week 12 LOCF||-0.09|-0.40|0.0026
72473826|NCT00798434|144471475|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-9.52||||0.0012|TWO_SIDED|95.0|-9.52|-9.09|||2-sided Van Elteren's test|||Week 12 LOCF||-9.09|-9.52|0.0012
72565880|NCT04179019|144662802|SUPERIORITY|||||||0.96|||||||t-test, 2 sided|||The intra-individual, paired, 24h urine aldosterone excretion rate following 2 weeks of amlodipine therapy was compared to the baseline pre-treatment 24h urine aldosterone excretion rate. The null hypothesis was that amlodipine therapy would result in no change in the 24h urine aldosterone excretion rate. Because only 2 participants completed the pilot study, the validity of the results is low.||||0.96
72565881|NCT04179019|144662803|SUPERIORITY|||||||0.29|||||||t-test, 2 sided|||The intra-individual, paired, plasma aldosterone concentration following 2 weeks of amlodipine therapy was compared to the baseline pre-treatment aldosterone concentration. The null hypothesis was that amlodipine therapy would result in no change in the plasma aldosterone value. Because only 2 participants completed the pilot study, the validity of the results is low.||||0.29
72473827|NCT00798434|144471476|SUPERIORITY_OR_OTHER||Hodges-Lehman estimate|0.0||||0.1005|TWO_SIDED|95.0|0.0|0.0||The protocol-defined analysis (ANOVA, parametric) not presented because normality assumptions were not met, instead an alternative analysis (Van-Elteren'ts test, non-parametric) as defined in the statistical analysis plan presented.|Van-Elteren's Test||Hodges-Lehman estimate of median treatment difference and CI|Week 12 LOCF||0.00|0.00|0.1005
72473828|NCT00798434|144471477|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.0218|TWO_SIDED|95.0|0.0|0.0|||2-sided Van Elteren's test|||Week 12 LOCF||0.00|0.00|0.0218
72473829|NCT00798434|144471478|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.7|STANDARD_ERROR_OF_MEAN|0.81|<|0.0001|TWO_SIDED|95.0|-6.3|-3.1|||ANCOVA|Covariates were treatment, study center, dosing time, age category, and daily sum rating of USS at baseline||Week 12 LOCF||-3.10|-6.30|<0.0001
72473830|NCT00798434|144471479|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.515||||0.1113|TWO_SIDED|95.0|0.909|2.528||Logistic regression determined the odds of improvement versus no improvement in dryness, where improvement was defined as dry at both weeks 8 and 12 relative to baseline incontinence.|Regression, Logistic|Covariates were treatment, study center, dosing time, and age category||LOCF||2.528|0.909|0.1113
72473831|NCT00798434|144471480|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.25|STANDARD_ERROR_OF_MEAN|0.11||0.023|TWO_SIDED|95.0|-0.47|-0.04|||ANCOVA|Covariates were treatment, study center, dosing time, age category, and baseline number of pads per 24 hours||Incontinence pads at Week 12 LOCF||-0.04|-0.47|0.0230
72473832|NCT00798434|144471480|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.06|STANDARD_ERROR_OF_MEAN|0.03||0.0909|TWO_SIDED|95.0|-0.12|0.01|||ANCOVA|Covariates were treatment, study center, dosing time, age category, and baseline number of creams per 24 hours||Creams at Week 12 LOCF||0.01|-0.12|0.0909
72473833|NCT00798434|144471480|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.03|STANDARD_ERROR_OF_MEAN|0.03||0.2039|TWO_SIDED|95.0|-0.08|0.02|||ANCOVA|Covariates were treatment, study center, dosing time, age category, and baseline number of powders per 24 hours||Powder at Week 12 LOCF||0.02|-0.08|0.2039
72473834|NCT00798434|144471481|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.096|||<|0.0001|TWO_SIDED|95.0|2.181|4.395|||Regression, Logistic|Covariates were treatment, study center, dosing time, and age category||Week 12 LOCF||4.395|2.181|<0.0001
72507223|NCT03151148|144546497|SUPERIORITY||Geometric mean ratio (GMR)|0.45||||0.242|TWO_SIDED|95.0|0.117|1.722|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator.|"TMT vs Placebo on Lesional Skin at Day 8~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||1.722|0.117|0.242
72507224|NCT03151148|144546497|SUPERIORITY||Geometric mean ratio (GMR)|0.47||||0.258|TWO_SIDED|95.0|0.129|1.735|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator.|"TMT vs Placebo on Lesional Skin at Day 11~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||1.735|0.129|0.258
72507225|NCT03151148|144546497|SUPERIORITY||Geometric mean ratio (GMR)|1.26||||0.726|TWO_SIDED|95.0|0.349|4.52|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator.|"TMT vs Placebo on Non-lesional Skin at Day 0~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||4.520|0.349|0.726
72473835|NCT00798434|144471484|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.506|||<|0.0001|TWO_SIDED|95.0|1.767|3.556||Logistic regression determined the odds of improvement versus no improvement in PPBC score, where improvement was defined as a negative change from baseline.|Regression, Logistic|Covariates were treatment, study center, dosing time, age category, and baseline PPBC category||Week 12 LOCF||3.556|1.767|<0.0001
72473836|NCT00798434|144471488|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.916||||0.0009|TWO_SIDED|95.0|1.305|2.811||Logistic regression determined the odds of improvement versus no improvement in PPBC score, where improvement was defined as an increase of 1 or more points in difference of scores relative to baseline.|Regression, Logistic|Covariates were treatment, study center, dosing time, age category, and baseline PPUS category||LOCF||2.811|1.305|0.0009
72473837|NCT00798434|144471490|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.12|STANDARD_ERROR_OF_MEAN|1.29|<|0.0001|TWO_SIDED|95.0|-9.65|-4.59|||ANCOVA|Covariates were treatment, study center, dosing time, age category, and baseline symptom/bother score||Week 12 LOCF||-4.59|-9.65|<0.0001
72473838|NCT00798434|144471491|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.48|STANDARD_ERROR_OF_MEAN|1.14|<|0.0001|TWO_SIDED|95.0|2.24|6.73|||ANCOVA|Covariates were treatment, study center, dosing time, age category, and baseline total health-related quality of life (HRQL) score.||Week 12 LOCF||6.73|2.24|<0.0001
72473839|NCT00798434|144471492|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.39|STANDARD_ERROR_OF_MEAN|1.44||0.0002|TWO_SIDED|95.0|2.57|8.22|||ANCOVA|Covariates were treatment, study center, dosing time, age category, and baseline HRQL subscale score||Coping Subscale at Week 12; LOCF||8.22|2.57|0.0002
72473840|NCT00798434|144471492|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.39|STANDARD_ERROR_OF_MEAN|1.29|<|0.0001|TWO_SIDED|95.0|2.84|7.93|||ANCOVA|Covariates were treatment, study center, dosing time, age category, and baseline HRQL subscale score||Concern Subscale at Week 12; LOCF||7.93|2.84|<0.0001
72473841|NCT00798434|144471492|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.09|STANDARD_ERROR_OF_MEAN|1.38||0.0032|TWO_SIDED|95.0|1.38|6.81|||ANCOVA|Covariates were treatment, study center, dosing time, age category, and baseline HRQL subscale score||Sleep Subscale at Week 12; LOCF||6.81|1.38|0.0032
72473842|NCT00798434|144471492|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.51|STANDARD_ERROR_OF_MEAN|1.03||0.0152|TWO_SIDED|95.0|0.49|4.53|||ANCOVA|Covariates were treatment, study center, dosing time, age category, and baseline HRQL subscale score||Social Subscale at Week 12; LOCF||4.53|0.49|0.0152
72473843|NCT00798434|144471493|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.537|||<|0.001|TWO_SIDED|95.0|2.281|5.484||Analysis determined the odds of responding on the OAB-S scale (satisfaction with OAB control) for Fesoterodine versus placebo, where a responder was defined as a response of 'satisfied' or better on all 7 questions at week 12.|Regression, Logistic|Covariates were treatment, study center, dosing time and age category||LOCF||5.484|2.281|<0.001
72473844|NCT00798434|144471494|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.881|||<|0.0001|TWO_SIDED|95.0|2.045|4.058||Analysis determined the odds of responding on the OAB-S scale (OAB medication expectation) for Fesoterodine versus placebo, where a responder was defined as a response of 'satisfied' or better on all 7 questions at week 12.|Regression, Logistic|Covariates were treatment, study center, dosing time and age category||LOCF||4.058|2.045|<0.0001
72473845|NCT00798434|144471495|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.18|STANDARD_ERROR_OF_MEAN|4.12||0.3163|TWO_SIDED|95.0|-4.13|12.49|||ANCOVA|Covariates were treatment, study center, dosing time, age category, and baseline total domain score||General Health Perception; LOCF||12.49|-4.13|0.3163
72473846|NCT00798434|144471495|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.29|STANDARD_ERROR_OF_MEAN|8.63||0.4698|TWO_SIDED|95.0|-23.7|11.11|||ANCOVA|Covariates were treatment, study center, dosing time, age category, and baseline total domain score||Incontinence Impact; LOCF||11.11|-23.70|0.4698
72473847|NCT00798434|144471495|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.85|STANDARD_ERROR_OF_MEAN|9.28||0.5321|TWO_SIDED|95.0|-24.58|12.88|||ANCOVA|Covariates were treatment, study center, dosing time, age category, and baseline total domain score||Role Limitations; LOCF||12.88|-24.58|0.5321
72473848|NCT00798434|144471495|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.81|STANDARD_ERROR_OF_MEAN|8.39||0.6523|TWO_SIDED|95.0|-20.74|13.12|||ANCOVA|Covariates were treatment, study center, dosing time, age category, and baseline total domain score||Physical Limitations; LOCF||13.12|-20.74|0.6523
72473849|NCT00798434|144471495|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.26|STANDARD_ERROR_OF_MEAN|6.8||0.6344|TWO_SIDED|95.0|-10.47|16.99|||ANCOVA|Covariates were treatment, study center, dosing time, age category, and baseline total domain score||Social Limitations; LOCF||16.99|-10.47|0.6344
72473850|NCT00798434|144471495|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.11|STANDARD_ERROR_OF_MEAN|8.38||0.2013|TWO_SIDED|95.0|-28.71|6.49|||ANCOVA|Covariates were treatment, study center, dosing time, age category, and baseline total domain score||Personal Relationships; LOCF||6.49|-28.71|0.2013
72473851|NCT00798434|144471495|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.07|STANDARD_ERROR_OF_MEAN|6.88||0.3831|TWO_SIDED|95.0|-19.96|7.83|||ANCOVA|Covariates were treatment, study center, dosing time, age category, and baseline total domain score||Emotions; LOCF||7.83|-19.96|0.3831
72473852|NCT00798434|144471495|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.46|STANDARD_ERROR_OF_MEAN|6.82||0.5167|TWO_SIDED|95.0|-9.3|18.23|||ANCOVA|Covariates were treatment, study center, dosing time, age category, and baseline total domain score||Sleep/Energy; LOCF||18.23|-9.30|0.5167
72473853|NCT00798434|144471495|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.19|STANDARD_ERROR_OF_MEAN|5.12||0.0532|TWO_SIDED|95.0|-20.53|0.15|||ANCOVA|Covariates were treatment, study center, dosing time, age category, and baseline total domain score||Severity of Urinary Symptoms; LOCF||0.15|-20.53|0.0532
72473854|NCT00798434|144471496|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0016|STANDARD_ERROR_OF_MEAN|0.0125||0.8959|TWO_SIDED|95.0|-0.0229|0.0262|||ANCOVA|Covariates were treatment, study center, dosing time, age category, and baseline single utility score||||0.0262|-0.0229|0.8959
72473855|NCT03898167|144471505|OTHER||Relative Participation|2.36|||||TWO_SIDED|95.0|1.99|2.8||95% CIs were calculated.||||Bivariable tables, Pearson chi-square and Kruskal-Wallis nonparametric tests were used to compare demographic/health care characteristics by study group. Log binomial regression was used to calculate screening proportion, participation difference, and relative participation (calculated as relative risk), with 95% CIs. Overall participation difference and relative participation for SC and SC with patient navigation vs TR were calculated by combining numerators and denominators from each group.||2.80|1.99|
72473856|NCT05177354|144471508|SUPERIORITY||Proportion|89.3|||<|0.001|ONE_SIDED|97.5|71.8|||"It is hypothesized that the proportion of low-back and leg pain subjects with a reduction in overstimulation sensation during Closed Loop On compared to Closed Loop Off period exceeds a performance goal of 50%.~H0: p ≤ 50% HA: p \> 50%"|Binomial Exact Test||||||71.8|<0.001
72473857|NCT03548220|144471517|SUPERIORITY||||||<|0.0001||||||2-sided p-value|Exact Cochran-Mantel-Haenszel|||||||<0.0001
72473858|NCT03548220|144471518|SUPERIORITY||LS Mean Difference|18.21|||<|0.0001|TWO_SIDED|95.0|12.41|24.01|||Mixed-effect Model Repeated Measure||Standard error = 2.913|||24.01|12.41|<0.0001
72473859|NCT03548220|144471521|SUPERIORITY||LS Mean Difference|-26.26|||<|0.0001|TWO_SIDED|95.0|-37.82|-14.7|||Mixed-effect Model Repeated Measure||Standard error = 5.788|||-14.70|-37.82|<0.0001
72473860|NCT03548220|144471522|SUPERIORITY||LS Mean Difference|-70.81||||0.0027|TWO_SIDED|95.0|-115.88|-25.74|||Mixed-effect Model Repeated Measure||Standard error = 22.488|||-25.74|-115.88|0.0027
72473861|NCT03548220|144471523|SUPERIORITY||LS Mean Difference|0.158||||0.0079|TWO_SIDED|95.0|0.043|0.273|||Mixed-effect Model Repeated Measure||Standard error = 0.0578|||0.273|0.043|0.0079
72565882|NCT04179019|144662804|SUPERIORITY|||||||0.83|||||||t-test, 2 sided|||The intra-individual, paired, change in plasma aldosterone concentration in response to an acute dose of amlodipine (6h post-dose) was compared to the baseline pre-treatment response to an acute dose of amlodipine. The null hypothesis was that an acute amlodipine dose would result in no acute change in the plasma aldosterone levels. Because only 2 participants completed the pilot study, the validity of the results is low.||||0.83
72473862|NCT03548220|144471524|SUPERIORITY||LS Mean Difference|-0.1011|||<|0.0001|TWO_SIDED|95.0|-0.1391|-0.0632|||Mixed-effect Model Repeated Measure||Standard error = 0.01904|||-0.0632|-0.1391|<0.0001
72473863|NCT03548220|144471525|SUPERIORITY||LS Mean Difference|-3.11||||0.0247|TWO_SIDED|95.0|-5.8|-0.41|||Mixed-effect Model Repeated Measure||Standard error = 1.352|||-0.41|-5.80|0.0247
72473864|NCT03548220|144471526|SUPERIORITY||LS Mean Difference|-3.25||||0.0421|TWO_SIDED|95.0|-6.39|-0.12|||Mixed-effect Model Repeated Measure||Standard error = 1.574|||-0.12|-6.39|0.0421
72473865|NCT03570892|144471537|SUPERIORITY||Unadjusted stratified cox model hazard r|1.07|||=|0.694|TWO_SIDED|95.0|0.82|1.4|||Stratified log-rank test one-sided|||||1.40|0.82|= 0.694
72473866|NCT00515671|144471602|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8868|TWO_SIDED||||||Mixed Models Analysis|||||||.8868
72473867|NCT00515671|144471603|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3328|TWO_SIDED||||||Mixed Models Analysis|||||||.3328
72473868|NCT00288639|144471605|SUPERIORITY_OR_OTHER_LEGACY||Mean Response Ratio|-22.72|STANDARD_DEVIATION|55.232||||95.0|-34.16|-11.28|||||Response ratio = 100 x \[(t - b)/(t + b)\] where t=treatment seizure frequency and b=baseline seizure frequency.|Noncomparative study. Summary stats, 2 sided 95% CI to est. effect size. No adjustments made to alpha levels to acct for multiple 2o endpts. Sample size=83 patients (pts) sufficient to detect statistically significant difference in % change from baseline in 28-day seizure rate with 80% power, true change from baseline approximately 25%. Allowing for dropouts assume 85% pts analyzed.||-11.28|-34.16|
72473869|NCT00288639|144471606|SUPERIORITY_OR_OTHER_LEGACY||Mean Response Ratio|-17.26|STANDARD_DEVIATION|48.797||||95.0|-27.36|-7.15|||||Response ratio = 100 x \[(t - b)/(t + b)\] where t=treatment seizure frequency and b=baseline seizure frequency.|Noncomparative study. Summary stats, 2 sided 95% CI to est. effect size. No adjustments made to alpha levels to acct for multiple 2o endpts. Sample size=83 patients (pts) sufficient to detect statistically significant difference in % change from baseline in 28-day seizure rate with 80% power, true change from baseline approximately 25%. Allowing for dropouts assume 85% pts analyzed.||-7.15|-27.36|
72473870|NCT00288639|144471607|SUPERIORITY_OR_OTHER_LEGACY||Mean Response Ratio|-22.43|STANDARD_DEVIATION|56.615||||95.0|-34.16|-10.71|||||1-28 Days. Response ratio = 100 x \[(t - b)/(t + b)\] where t= 4 wk interval seizure frequency and b=baseline seizure frequency.|Noncomparative study.Summary stats, 2 sided 95% CI to est. effect size. No adjustments made to alpha levels to acct for multiple 2o endpts.Sample size=83 patients (pts) sufficient to detect statistically significant difference in % change from baseline in 28-day seizure rate with 80% power, true change from baseline approximately 25%.Allowing for dropouts assume 85% pts analyzed.||-10.71|-34.16|
72473871|NCT00288639|144471607|SUPERIORITY_OR_OTHER_LEGACY||Mean Response Ratio|-22.83|STANDARD_DEVIATION|57.543||||95.0|-34.74|-10.91|||||29-56 Days. Response ratio = 100 x \[(t - b)/(t + b)\] where t= 4 wk interval seizure frequency and b=baseline seizure frequency.|Noncomparative study.Summary stats, 2 sided 95% CI to est. effect size. No adjustments made to alpha levels to acct for multiple 2o endpts. Sample size=83 patients (pts) sufficient to detect statistically significant difference in % change from baseline in 28-day seizure rate with 80% power,true change from baseline approximately 25%. Allowing for dropouts assume 85% pts analyzed.||-10.91|-34.74|
72473872|NCT00288639|144471607|SUPERIORITY_OR_OTHER_LEGACY||Mean Response Ratio|-27.18|STANDARD_DEVIATION|59.323||||95.0|-39.9|-14.46|||||57-84 Days. Response ratio = 100 x \[(t - b)/(t + b)\] where t= 4 wk interval seizure frequency and b=baseline seizure frequency. .|Noncomparative study.Summary stats, 2 sided 95% CI to est. effect size. No adjustments made to alpha levels to acct for multiple 2o endpts. Sample size=83 patients (pts) sufficient to detect statistically significant difference in % change from baseline in 28-day seizure rate with 80% power, true change from baseline approximately 25%. Allowing for dropouts assume 85% pts analyzed.||-14.46|-39.90|
72473873|NCT00288639|144471607|SUPERIORITY_OR_OTHER_LEGACY||Mean Response Ratio|-30.75|STANDARD_DEVIATION|58.11||||95.0|-43.44|-18.06|||||85-112 Days. Response ratio=100 x \[(t - b)/(t + b)\] where t= 4 wk interval seizure frequency and b=baseline seizure frequency.|Noncomparative study.Summary stats, 2 sided 95% CI to est. effect size. No adjustments made to alpha levels to acct for multiple 2o endpts. Sample size=83 patients (pts) sufficient to detect statistically significant difference in % change from baseline in 28-day seizure rate with 80% power, true change from baseline approximately 25%.Allowing for dropouts assume 85% pts analyzed.||-18.06|-43.44|
72473874|NCT00288639|144471607|SUPERIORITY_OR_OTHER_LEGACY||Mean Response Ratio|-38.75|STANDARD_DEVIATION|59.368||||95.0|-51.79|-25.7|||||113-140 Days. Response ratio=100 x \[(t - b)/(t + b)\] where t= 4 wk interval seizure frequency and b=baseline seizure frequency.|Noncomparative study.Summary stats, 2 sided 95% CI to est. effect size. No adjustments made to alpha levels to acct for multiple 2o endpts. Sample size=83 patients (pts) sufficient to detect statistically significant difference in % change from baseline in 28-day seizure rate with 80% power, true change from baseline approximately 25%.Allowing for dropouts assume 85% pts analyzed.||-25.70|-51.79|
72473875|NCT00288639|144471607|SUPERIORITY_OR_OTHER_LEGACY||Mean Response Ratio|-44.24|STANDARD_DEVIATION|62.703||||95.0|-58.47|-30.01|||||\>140 Days. Response ratio= 100 x \[(t - b)/(t + b)\] where t= 4 wk interval seizure frequency and b=baseline seizure frequency.|Noncomparative study.Summary stats, 2 sided 95% CI to est. effect size. No adjustments made to alpha levels to acct for multiple 2o endpts. Sample size=83 patients (pts) sufficient to detect statistically significant difference in % change from baseline in 28-day seizure rate with 80% power,true change from baseline approximately 25%.Allowing for dropouts assume 85% pts analyzed.||-30.01|-58.47|
72473876|NCT00288639|144471608|SUPERIORITY_OR_OTHER_LEGACY||Mean Response Ratio|7.19|STANDARD_DEVIATION|84.425||||95.0|-17.6|31.98|||||Simple Partial Seizures. Response ratio = 100 x \[(t - b)/(t + b)\] where t=treatment seizure frequency and b=baseline seizure frequency.|Noncomparative study. Summary stats, 2 sided 95% CI to est. effect size. No adjustments made to alpha levels to acct for multiple 2o endpts. Sample size=83 patients (pts) sufficient to detect statistically significant difference in % change from baseline in 28-day seizure rate with 80% power, true change from baseline approximately 25%. Allowing for dropouts assume 85% pts analyzed.||31.98|-17.60|
72565883|NCT02610816|144662805|SUPERIORITY|||||||0.04||||||P-values are not adjusted for multiplicity, since a single primary endpoint is analyzed|Mixed Models Analysis|No adjustment of degrees of freedom is needed.||The primary treatment comparison was to compare change in PEESS V2.0 scores of 1FED versus 4FED. The primary null hypothesis was 4FED would be no more effective than 1FED. This was designed as a superiority trial.||||0.04
72565884|NCT02610816|144662806|SUPERIORITY||||||<|0.0001||||||This is a calculated p-value. The threshold for statistical significance is p \<0.05.|Mixed Models Analysis|||||||<0.0001
72565885|NCT02610816|144662806|SUPERIORITY||||||<|0.0001||||||This is a calculated p-value. The threshold for statistical significance is p \<0.05|Mixed Models Analysis|||||||<0.0001
72565886|NCT02610816|144662807|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.0
72565887|NCT02610816|144662810|SUPERIORITY|||||||0.93|||||||Mixed Models Analysis|||||||0.93
72473877|NCT00288639|144471608|SUPERIORITY_OR_OTHER_LEGACY||Mean Response Ratio|-22.24|STANDARD_DEVIATION|68.058||||95.0|-37.8|-6.69|||||Complex Partial Seizures. Response ratio = 100 x \[(t - b)/(t + b)\] where t=treatment seizure frequency and b=baseline seizure frequency.|Noncomparative study. Summary stats, 2 sided 95% CI to est. effect size. No adjustments made to alpha levels to acct for multiple 2o endpts. Sample size=83 patients (pts) sufficient to detect statistically significant difference in % change from baseline in 28-day seizure rate with 80% power, true change from baseline approximately 25%. Allowing for dropouts assume 85% pts analyzed.||-6.69|-37.80|
72473878|NCT00288639|144471608|SUPERIORITY_OR_OTHER_LEGACY||Mean Response Ratio|-23.85|STANDARD_DEVIATION|84.313||||95.0|-55.33|7.64|||||Evolved to Generalized. Response ratio = 100 x \[(t - b)/(t + b)\] where t=treatment seizure frequency and b=baseline seizure frequency.|Noncomparative study. Summary stats, 2 sided 95% CI to est. effect size. No adjustments made to alpha levels to acct for multiple 2o endpts. Sample size=83 patients (pts) sufficient to detect statistically significant difference in % change from baseline in 28-day seizure rate with 80% power, true change from baseline approximately 25%. Allowing for dropouts assume 85% pts analyzed.||7.64|-55.33|
72473879|NCT00288639|144471612|SUPERIORITY_OR_OTHER_LEGACY||Mean Response Ratio|-24.93|STANDARD_DEVIATION|60.867||||95.0|-43.66|-6.2|||||Seizure freq. ≤3 / 28 d. Resp. ratio = 100 x \[(t - b)/(t + b)\] where t=treatment seizure frequency and b=baseline seizure frequency.|Noncomparative study. Summary stats, 2 sided 95% CI to est. effect size. No adjustments made to alpha levels to acct for multiple 2o endpts. Sample size=83 patients (pts) sufficient to detect statistically significant difference in % change from baseline in 28-day seizure rate with 80% power, true change from baseline approximately 25%. Allowing for dropouts assume 85% pts analyzed.||-6.20|-43.66|
72473880|NCT00288639|144471612|SUPERIORITY_OR_OTHER_LEGACY||Mean Response Ratio|-20.78|STANDARD_DEVIATION|50.334||||95.0|-35.24|-6.33|||||Seizure freq. \>3 / 28 d. Resp. ratio = 100 x \[(t - b)/(t + b)\] where t=treatment seizure frequency and b=baseline seizure frequency.|Noncomparative study. Summary stats, 2 sided 95% CI to est. effect size. No adjustments made to alpha levels to acct for multiple 2o endpts. Sample size=83 patients (pts) sufficient to detect statistically significant difference in % change from baseline in 28-day seizure rate with 80% power, true change from baseline approximately 25%. Allowing for dropouts assume 85% pts analyzed.||-6.33|-35.24|
72473881|NCT02385240|144471632|EQUIVALENCE|provides 85% power of success|Equivalence ratio|1.034|||||TWO_SIDED|90.0|-7.52|10.72|||Wald's method|||||10.72|-7.52|
72473882|NCT02385240|144471633|EQUIVALENCE|provides 85% power of success|Equivalence ratio|1.05|||||TWO_SIDED|90.0|-6.94|11.33|||Wald's method|||||11.33|-6.94|
72473883|NCT02385240|144471634|EQUIVALENCE|provides 85% power of success|Equivalence ratio|1.26|||||TWO_SIDED|90.0|-1.77|15.46|||Wald's method|||||15.46|-1.77|
72473884|NCT01014208|144471635|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.12||||0.333|TWO_SIDED|95.0|0.89|1.42||p-value from stratified log-rank test are adjusted for stratification factors.|Stratified Log-rank test||The Pike estimator was the statistical method used to estimate the hazard ratio.|||1.42|0.89|0.333
72473885|NCT01014208|144471636|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.84||||0.4053|TWO_SIDED|95.0|0.56|1.24||p-value for the test of Odds Ratio being 1.|Cochran-Mantel-Haenszel||For Category title- Independent reviewer-assessed OR|||1.24|0.56|0.4053
72473886|NCT01014208|144471636|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.66||||0.1167|TWO_SIDED|95.0|0.39|1.1||p-value for the test of Odds Ratio being 1.|Cochran-Mantel-Haenszel||For Category title- Independent reviewer-assessed CR|||1.10|0.39|0.1167
72473887|NCT01014208|144471637|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.15||||0.8209|TWO_SIDED|95.0|0.55|2.43||p-value for the test of Odds Ratio being 1.|Cochran-Mantel-Haenszel||For Category title- Independent reviewer-assessed OR|||2.43|0.55|0.8209
72473888|NCT01014208|144471637|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.23||||0.6313|TWO_SIDED|95.0|0.62|2.43||p-value for the test of Odds Ratio being 1.|Cochran-Mantel-Haenszel||For Category title- Independent reviewer-assessed CR|||2.43|0.62|0.6313
72565888|NCT02610816|144662811|SUPERIORITY|||||||0.74|||||||Mixed Models Analysis|||||||0.74
72473889|NCT01014208|144471638|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.1||||0.346|TWO_SIDED|95.0|0.9|1.36||p-value from stratified log-rank test are adjusted for stratification factors.|Stratified log-rank test||Confidence Interval estimated using the Brookmeyer-Crowley method. HR are estimated using Pike estimator. A hazard ratio \<1 indicates a lower probability of recovery with Ofatumumab compared to Rituximab. HR was adjusted for stratification factors.|||1.36|0.90|0.346
72473890|NCT01014208|144471639|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.9||||0.377|TWO_SIDED|95.0|0.7|1.15||p-value from stratified log-rank test are adjusted for stratification factors.|Stratified log-rank test||Confidence Interval estimated using the Brookmeyer-Crowley method. HR are estimated using Pike estimator. A hazard ratio \<1 indicates a lower probability of recovery with Ofatumumab compared to Rituximab. HR was adjusted for stratification factors.|||1.15|0.70|0.377
72473891|NCT01014208|144471640|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.57||||0.1161|TWO_SIDED|95.0|0.83|9.5||p-value for the test of Odds Ratio being 1.|Cochran-Mantel-Haenszel|||||9.50|0.83|0.1161
72473892|NCT01014208|144471641|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.84||||0.4481|TWO_SIDED|95.0|0.56|1.27||p-value for the test of Odds Ratio being 1.|Cochran-Mantel-Haenszel||Statistics are presented for Completion rate|||1.27|0.56|0.4481
72473893|NCT01014208|144471642|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.03||||0.978|TWO_SIDED|95.0|-2.11|2.17|||ANCOVA|||||2.170|-2.110|0.978
72473894|NCT01014208|144471643|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.129||||0.387|TWO_SIDED|95.0|-1.434|3.691|||ANCOVA|||||3.691|-1.434|0.387
72565889|NCT02610816|144662812|SUPERIORITY|||||||0.36|||||||Mixed Models Analysis|||||||0.36
72565890|NCT02139124|144662827|SUPERIORITY||Mean Difference (Final Values)|-2.0||||0.675|TWO_SIDED|95.0|-6.6|2.6||The model includes terms for treatment and baseline Clinician ADHD-5-RS score as a covariate.|ANCOVA|Analyses utilize ANCOVA models with Dunnett's adjustments for multiple pairwise comparisons for each active dose group with placebo.||"The null hypothesis is the mean Clinician ADHD-5-RS total score at Visit 6 is not different between the active treatment and placebo."||2.6|-6.6|0.6750
72565891|NCT02139124|144662827|SUPERIORITY||Mean Difference (Final Values)|-6.9||||0.0013|TWO_SIDED|95.0|-11.5|-2.2||The model includes terms for treatment and baseline Clinician ADHD-5-RS score as a covariate.|ANCOVA|Analyses utilize ANCOVA models with Dunnett's adjustments for multiple pairwise comparisons for each active dose group with placebo.||The null hypothesis is the mean Clinician ADHD-5-RS total score at Visit 6 is not different between the active treatment and placebo||-2.2|-11.5|0.0013
72398319|NCT00412854|144303010|NON_INFERIORITY_OR_EQUIVALENCE|The upper limit of the standardized asymptotic 95% confidence interval (CI) on the group difference \[Infanrix+Hiberix Group minus Infanrix/Hib Group\] in percentage of subjects with a vaccine response was ≤ 10%.|Difference in seroresponse rate|0.0|||||TWO_SIDED|95.0|-2.29|2.3||||||"Difference in vaccine response rates against PT:~To demonstrate that the immunogenicity of Infanrix™/Hib vaccine administered at 3, 4 and 5 months of age (Infanrix/Hib Group) was non-inferior to that of the concomitant administration of Infanrix™ and Hiberix™ vaccines at the same age (Infanrix+Hiberix Group), in terms of immune response to all vaccine antigens, one month after the three-dose vaccination course."||2.30|-2.29|
72398320|NCT00412854|144303010|NON_INFERIORITY_OR_EQUIVALENCE|The upper limit of the standardized asymptotic 95% confidence interval (CI) on the group difference \[Infanrix+Hiberix Group minus Infanrix/Hib Group\] in percentage of subjects with a vaccine response was ≤ 10%.|Difference in seroresponse rate|0.0|||||TWO_SIDED|95.0|-2.29|2.3||||||"Difference in vaccine response rates against FHA:~To demonstrate that the immunogenicity of Infanrix™/Hib vaccine administered at 3, 4 and 5 months of age (Infanrix/Hib Group) was non-inferior to that of the concomitant administration of Infanrix™ and Hiberix™ vaccines at the same age (Infanrix+Hiberix Group), in terms of immune response to all vaccine antigens, one month after the three-dose vaccination course."||2.30|-2.29|
72398321|NCT00412854|144303010|NON_INFERIORITY_OR_EQUIVALENCE|The upper limit of the standardized asymptotic 95% confidence interval (CI) on the group difference \[Infanrix+Hiberix Group minus Infanrix/Hib Group\] in percentage of subjects with a vaccine response was ≤ 10%.|Difference in seroresponse rate|1.23|||||TWO_SIDED|95.0|-2.17|5.07||||||"Difference in vaccine response rates against PRN:~To demonstrate that the immunogenicity of Infanrix™/Hib vaccine administered at 3, 4 and 5 months of age (Infanrix/Hib Group) was non-inferior to that of the concomitant administration of Infanrix™ and Hiberix™ vaccines at the same age (Infanrix+Hiberix Group), in terms of immune response to all vaccine antigens, one month after the three-dose vaccination course."||5.07|-2.17|
72473895|NCT01014208|144471644|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.93||||0.479|TWO_SIDED|95.0|0.74|1.16||p-value from stratified log-rank test are adjusted for stratification factors.|Stratified Log-Rank|||Statistics are presented for Category-Neutrophils, Cycle 1. Confidence Interval (CI) estimated using the Brookmeyer-Crowley method. HR are estimated using the Pike estimator. A hazard ratio \<1 indicates a lower probability of recovery with Ofatumumab compared to Rituximab. HR was adjusted for stratification factors.||1.16|0.74|0.479
72473896|NCT01014208|144471644|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.81||||0.059|TWO_SIDED|95.0|0.64|1.02||p-value from stratified log-rank test are adjusted for stratification factors.|Stratified Log-Rank|||Statistics are presented for Category-Neutrophils, Cycle 2. Confidence Interval (CI) estimated using the Brookmeyer-Crowley method. HR are estimated using the Pike estimator. A hazard ratio \<1 indicates a lower probability of recovery with Ofatumumab compared to Rituximab. HR was adjusted for stratification factors.||1.02|0.64|0.059
72473897|NCT01014208|144471644|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.11||||0.451|TWO_SIDED|95.0|0.83|1.48||p-value from stratified log-rank test are adjusted for stratification factors.|Stratified Log-Rank|||Statistics are presented for Category-Neutrophils, Cycle 3. Confidence Interval (CI) estimated using the Brookmeyer-Crowley method. HR are estimated using the Pike estimator. A hazard ratio \<1 indicates a lower probability of recovery with Ofatumumab compared to Rituximab. HR was adjusted for stratification factors.||1.48|0.83|0.451
72473898|NCT01014208|144471644|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.05||||0.597|TWO_SIDED|95.0|0.86|1.29||p-value from stratified log-rank test are adjusted for stratification factors.|Stratified Log-Rank|||Statistics are presented for Category-Platelets, Cycle 1. Confidence Interval (CI) estimated using the Brookmeyer-Crowley method. HR are estimated using the Pike estimator. A hazard ratio \<1 indicates a lower probability of recovery with Ofatumumab compared to Rituximab. HR was adjusted for stratification factors.||1.29|0.86|0.597
72473899|NCT01014208|144471644|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.88||||0.199|TWO_SIDED|95.0|0.7|1.1||p-value from stratified log-rank test are adjusted for stratification factors.|Stratified Log-Rank|||Statistics are presented for Category-Platelets, Cycle 2. Confidence Interval (CI) estimated using the Brookmeyer-Crowley method. HR are estimated using the Pike estimator. A hazard ratio \<1 indicates a lower probability of recovery with Ofatumumab compared to Rituximab. HR was adjusted for stratification factors.||1.10|0.70|0.199
72473900|NCT01014208|144471644|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.21||||0.102|TWO_SIDED|95.0|0.93|1.59||p-value from stratified log-rank test are adjusted for stratification factors.|Stratified Log-Rank|||Statistics are presented for Category-Platelets, Cycle 3. Confidence Interval (CI) estimated using the Brookmeyer-Crowley method. HR are estimated using the Pike estimator. A hazard ratio \<1 indicates a lower probability of recovery with Ofatumumab compared to Rituximab. HR was adjusted for stratification factors.||1.59|0.93|0.102
72398322|NCT04483011|144303019|SUPERIORITY||Mean Difference (Net)|2.12|STANDARD_DEVIATION|4.72||0.034|TWO_SIDED|||||\< 0.05|Wilcoxon (Mann-Whitney)||The p value in RiaGev group at Day 5 over Dave 1 is reported.|A comparison between before and after RiaGev supplementation.||||0.034
72398323|NCT04483011|144303019|SUPERIORITY||Mean Difference (Net)|-0.2|STANDARD_DEVIATION|2.79||0.265|TWO_SIDED|||||p \> 0.05|Wilcoxon (Mann-Whitney)||The p value in Comparator group at Day 5 over Day 1 is reported.|A comparison between before and after supplementation of Comparator.||||0.265
72398324|NCT04483011|144303019|SUPERIORITY||Mean Difference (Net)|2.12|STANDARD_DEVIATION|4.72||0.044|TWO_SIDED|||||\< 0.05|ANCOVA||The p value between RiaGev and Comparator groups at Day 5 over Day 1 is reported.|A comparison between RiaGev and Comparator groups.||||0.044
72473901|NCT01014208|144471645|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.6||||0.035|TWO_SIDED|95.0|0.36|1.0||p-value from stratified log-rank test are adjusted for stratification factors.|Stratified Log-Rank||Confidence Interval estimated using the Brookmeyer-Crowley method. HR are estimated using Pike estimator. A hazard ratio \<1 indicates a lower probability of recovery with Ofatumumab compared to Rituximab. HR was adjusted for stratification factors.|||1.00|0.36|0.035
72473902|NCT00225017|144471657|NON_INFERIORITY_OR_EQUIVALENCE|25 subjects per arm will have 80% power to detect a difference between groups in mean FMD change of 2.9%, and 90% power to detect a mean FMD change of 3.4%|Mean Difference (Net)|-0.384|STANDARD_DEVIATION|1.0||0.601|TWO_SIDED|95.0|-2.08|1.312|||Wilcoxon (Mann-Whitney)|||||1.312|-2.080|0.601
72398325|NCT04483011|144303020|SUPERIORITY||Mean Difference (Net)|1.33|STANDARD_DEVIATION|1.88||0.008|TWO_SIDED|||||p \< 0.05|Wilcoxon (Mann-Whitney)||The p value in RiaGev group at Day 5 over Day 1 is reported.|A comparison between before and after supplementation of RiaGev.||||0.008
72473903|NCT00225017|144471658|SUPERIORITY_OR_OTHER||||||<|0.009||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.009
72473904|NCT00225017|144471659|SUPERIORITY_OR_OTHER|||||||0.141||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.141
72473905|NCT04020185|144471706|OTHER||maximum tolerated dose (monotherapy)|1200.0|||||TWO_SIDED|||||||||||||
72473906|NCT00527787|144471713|SUPERIORITY_OR_OTHER||proportions|4.1||||0.001|TWO_SIDED|95.0|1.9|7.7|||Cochran-Mantel-Haenszel|CMH test stratified by use of low-dose aspirin (Yes/No) at randomization.||The primary efficacy endpoint was the proportion of subjetcs developing gastric ulcers throughout 6 months of study treatment. A summary, including cumulative frequency and percentage with associated 95% confidence intervals was produced for the observational incidences of gastric ulcers at 6 months. The cumulative proportion of subjects developing gastric ulcers at 6 months was analyzed using the CMH test stratified by use of low-dose aspirin (Yes/No) at randomization.||7.7|1.9|0.001
72473907|NCT00527787|144471714|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||Cochran-Mantel-Haenszel|||||||0.001
72473908|NCT00527787|144471715|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||Cochran-Mantel-Haenszel|||||||0.001
72473909|NCT00527787|144471716|SUPERIORITY_OR_OTHER|||||||0.003||95.0|||||Cochran-Mantel-Haenszel|||||||0.003
72473910|NCT00527787|144471717|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||Cochran-Mantel-Haenszel|||||||0.001
72473911|NCT03433677|144471722|SUPERIORITY||Median Difference (Final Values)|0.0||||0.375|TWO_SIDED|95.0|0.0|0.0|||Wilcoxon signed-rank test|||||0.00|0.00|0.375
72473912|NCT03433677|144471723|SUPERIORITY|||||||0.468|||||||Prescott's Exact test|||||||0.468
72473913|NCT03433677|144471724|SUPERIORITY|||||||0.028|||||||Wilcoxon (Mann-Whitney)|||||||0.028
72507226|NCT03151148|144546497|SUPERIORITY||Geometric mean ratio (GMR)|0.32||||0.08|TWO_SIDED|95.0|0.088|1.145|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator.|"TMT vs Placebo on Non-lesional Skin at Day 4~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||1.145|0.088|0.080
72473914|NCT03433677|144471725|SUPERIORITY||LSMean Difference|-1.8||||0.304|TWO_SIDED|95.0|-5.3|1.7|||Mixed Models Analysis|||||1.7|-5.3|0.304
72473915|NCT03433677|144471726|SUPERIORITY||LSMean Difference|-2.4||||0.057|TWO_SIDED|95.0|-4.8|0.1|||Mixed Models Analysis|||||0.1|-4.8|0.057
72473916|NCT03433677|144471727|SUPERIORITY||LSMeans|0.11||||0.177|TWO_SIDED|95.0|-0.05|0.27|||Mixed Models Analysis||LSMean Difference|||0.27|-0.05|0.177
72473917|NCT02783027|144471770|SUPERIORITY|||||||0.76|||||||t-test, 2 sided|Two sample t-test on the change in sleep quality from baseline to 4 months.||||||0.76
72473918|NCT02783027|144471771|SUPERIORITY||||||<|0.0001||||||Test for group\*time interaction.|Mixed Models Analysis|||||||<0.0001
72473919|NCT02783027|144471772|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|Test for group\*time interaction.||||||<0.0001
72473920|NCT02783027|144471773|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|Test for group\*time interaction.||||||<0.0001
72473921|NCT02783027|144471774|SUPERIORITY|||||||0.91|||||||t-test, 2 sided|Two sample t-test for change in Occupational Fatigue Exhaustion Recovery (OFER) inter-shift recovery between groups||||||0.91
72473922|NCT02383940|144471824|SUPERIORITY||Least squares mean difference|-0.35|STANDARD_ERROR_OF_MEAN|0.207||0.1|TWO_SIDED|95.0|-0.76|0.06||Threshold for significance = 0.05|MMRM||Difference is sotagliflozin - placebo|Between-group comparison was based on MMRM model with treatment, randomization strata of insulin delivery (MDI, CSII) and Week-4 A1C (\<=10%, \>10%), time (study week), and a treatment-by-time interaction as fixed categorical effects, and baseline A1C-by-time interaction as a covariate.||0.06|-0.76|0.10
72473923|NCT04308590|144471841|EQUIVALENCE|The primary analysis will determine whether there is a difference between treatment groups in terms of change from Baseline to Week 22 in 24-hour average SBP. This was performed using a linear mixed-model-for-repeated-measures (MMRM) analysis using a placebo wash-out multiple imputation for treatment discontinuation and for patients that use rescue medication.|Least squares mean difference|-2.67||||0.416|TWO_SIDED|95.0|-9.096|3.766|||Mixed Models Analysis|||||3.766|-9.096|0.4160
72473924|NCT02175641|144471940|OTHER|Generalized linear mixed-effects models with a logistic link|Odds Ratio (OR)|1.07|||>|0.05|TWO_SIDED|95.0|0.62|1.84|||Regression, Logistic|||||1.84|0.62|>0.05
72473925|NCT02175641|144471941|OTHER|Mixed effect models controlling for study site.|Time by treatment interaction coefficien|0.15|STANDARD_ERROR_OF_MEAN|0.59||0.804|TWO_SIDED||||||Mixed Models Analysis|||||||0.804
72473926|NCT02175641|144471942|OTHER||Time*treatment interaction coefficient|0.05|STANDARD_ERROR_OF_MEAN|0.09||0.91|TWO_SIDED||||||Mixed Models Analysis|||||||0.91
72473927|NCT02175641|144471943|OTHER|Mixed effect models controlling for study site.|time*treatment interaction coefficient|-0.34|STANDARD_ERROR_OF_MEAN|0.74||0.64|TWO_SIDED||||||Mixed Models Analysis|||||||0.64
72473928|NCT02175641|144471944|OTHER|Mixed effect models controlling for study site.|Time*treatment interaction coefficient|0.08|STANDARD_ERROR_OF_MEAN|0.09||0.38|TWO_SIDED||||||Mixed Models Analysis|||||||0.38
72473929|NCT02175641|144471945|OTHER|Mixed effect models controlling for study site.|Time*treatment interaction coefficient|0.02|STANDARD_ERROR_OF_MEAN|0.02||0.39|TWO_SIDED||||||Mixed Models Analysis|||||||0.39
72473930|NCT02175641|144471946|OTHER|Mixed effect models controlling for study site.|Time*treatment interaction coefficient|0.23|STANDARD_ERROR_OF_MEAN|0.37||0.52|TWO_SIDED||||||Mixed Models Analysis|||||||0.52
72473931|NCT02175641|144471947|OTHER|Mixed effect models controlling for study site.|Time*treatment interaction coefficient|3.83|STANDARD_ERROR_OF_MEAN|3.28||0.24|TWO_SIDED||||||Mixed Models Analysis|||||||0.24
72398326|NCT04483011|144303020|SUPERIORITY||Mean Difference (Net)|0.34|STANDARD_DEVIATION|1.34||0.297|TWO_SIDED|||||p \> 0.05|Wilcoxon (Mann-Whitney)||The p value in Comparator group at Day 5 over Day 1 is reported.|A comparison between before and after supplementation with Comparator.||||0.297
72623087|NCT01385995|144776486|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3||||0.86|TWO_SIDED|95.0|-3.3|2.7|||Regression, Linear|||Based on an intent-to-treat approach, a linear mixed effect model was used to estimate the association between therapy and measures of glucose indices, in this case fasting glucose, between CPAP and sham-CPAP, stratified for the most severe sleep apnea group (Apnea-Hypopnea Index (AHI) \>=30) in order to assess whether the differences in the effect of CPAP on outcomes were observed according to sleep apnea severity. N=25.||2.7|-3.3|0.86
72473932|NCT03921723|144471949|EQUIVALENCE|Bioequivalence is established when the 90 percent (%) confidence interval of the ratio for AUC (0 to t) between treatment formulations (Prototype A versus DTG Reference Treatment) are within the range of 0.80 to 1.25|Ratio|0.97|||||TWO_SIDED|90.0|0.91|1.03||||||||1.03|0.91|
72473933|NCT03921723|144471949|EQUIVALENCE|Bioequivalence is established when the 90% confidence interval of the ratio for AUC (0 to t) between treatment formulations (Prototype B versus DTG Reference Treatment) are within the range of 0.80 to 1.25|Ratio|1.12|||||TWO_SIDED|90.0|1.05|1.2||||||||1.20|1.05|
72473934|NCT03921723|144471968|EQUIVALENCE|Bioequivalence is established when the 90% confidence interval of the ratio for AUC (0 to inf) between treatment formulations (Prototype A versus DTG Reference Treatment) are within the range of 0.80 to 1.25|Ratio|0.96|||||TWO_SIDED|90.0|0.91|1.03||||||||1.03|0.91|
72473935|NCT03921723|144471968|EQUIVALENCE|Bioequivalence is established when the 90% confidence interval of the ratio for AUC (0 to inf) between treatment formulations (Prototype B versus DTG Reference Treatment) are within the range of 0.80 to 1.25|Ratio|1.13||||||90.0|1.06|1.2||||||||1.20|1.06|
72473936|NCT03921723|144471969|EQUIVALENCE|Bioequivalence is established when the 90% confidence interval of the ratio for Cmax between treatment formulations (Prototype A versus DTG Reference Treatment) are within the range of 0.80 to 1.25|Ratio|1.09|||||TWO_SIDED|90.0|1.01|1.19||||||||1.19|1.01|
72473937|NCT03921723|144471969|EQUIVALENCE|Bioequivalence is established when the 90% confidence interval of the ratio for Cmax between treatment formulations (Prototype B versus DTG Reference Treatment) are within the range of 0.80 to 1.25|Ratio|1.22|||||TWO_SIDED|90.0|1.13|1.33||||||||1.33|1.13|
72473938|NCT02574845|144471984|SUPERIORITY_OR_OTHER_LEGACY||Adjusted geometric mean ratio T1/REF (%)|101.95|||||TWO_SIDED|90.0|89.49|116.15|||ANOVA|Analysis of variance (ANOVA) model on the logarithmic scale including the effects: 'sequence', 'subjects within sequence', 'period' and 'treatment'.||This statistical analysis assess the effect of coadministration of 10 mg metformin hydrochloride on the primary outcome measure of the REF treatment.||116.15|89.49|
72473939|NCT02574845|144471984|SUPERIORITY_OR_OTHER_LEGACY||Adjusted geometric mean ratio T2/REF (%)|106.09|||||TWO_SIDED|90.0|96.12|117.11|||ANOVA|ANOVA model on the logarithmic scale including the effects: 'sequence', 'subjects within sequence', 'period' and 'treatment'.||This statistical analysis assess the effect of coadministration of 50 mg metformin hydrochloride on the primary outcome measure of the REF treatment.||117.11|96.12|
72473940|NCT02574845|144471984|SUPERIORITY_OR_OTHER_LEGACY||Adjusted geometric mean ratio T3/REF (%)|152.18|||||TWO_SIDED|90.0|135.12|171.41|||ANOVA|ANOVA model on the logarithmic scale including the effects: 'sequence', 'subjects within sequence', 'period' and 'treatment'.||This statistical analysis assess the effect of coadministration of 500 mg metformin hydrochloride on the primary outcome measure of the REF treatment.||171.41|135.12|
72473941|NCT02574845|144471984|SUPERIORITY_OR_OTHER_LEGACY||Adjusted geometric mean ratio T4/REF (%)|106.97|||||TWO_SIDED|90.0|94.34|121.3|||ANOVA|ANOVA model on the logarithmic scale including the effects: 'sequence', 'subjects within sequence', 'period' and 'treatment'.||This statistical analysis assess the effect of coadministration of 1 mg furosemide on the primary outcome measure of the REF treatment.||121.30|94.34|
72473942|NCT02574845|144471984|SUPERIORITY_OR_OTHER_LEGACY||Adjusted geometric mean ratio T5/REF (%)|115.92|||||TWO_SIDED|90.0|101.93|131.82|||ANOVA|ANOVA model on the logarithmic scale including the effects: 'sequence', 'subjects within sequence', 'period' and 'treatment'.||This statistical analysis assess the effect of coadministration of 5 mg furosemide on the primary outcome measure of the REF treatment.||131.82|101.93|
72473943|NCT02574845|144471985|SUPERIORITY_OR_OTHER_LEGACY||Adjusted geometric mean ratio T1/REF (%)|102.47|||||TWO_SIDED|90.0|87.19|120.42|||ANOVA|ANOVA model on the logarithmic scale including the effects: 'sequence', 'subjects within sequence', 'period' and 'treatment'.||This statistical analysis assess the effect of coadministration of 10 mg metformin hydrochloride on the primary outcome measure of the REF treatment.||120.42|87.19|
72507227|NCT03151148|144546497|SUPERIORITY||Geometric mean ratio (GMR)|0.81||||0.748|TWO_SIDED|95.0|0.225|2.917|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator.|"TMT vs Placebo on Non-lesional Skin at Day 7~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||2.917|0.225|0.748
72473944|NCT02574845|144471985|SUPERIORITY_OR_OTHER_LEGACY||Adjusted geometric mean ratio T2/REF (%)|106.98|||||TWO_SIDED|90.0|92.54|123.69|||ANOVA|ANOVA model on the logarithmic scale including the effects: 'sequence', 'subjects within sequence', 'period' and 'treatment'.||This statistical analysis assess the effect of coadministration of 50 mg metformin hydrochloride on the primary outcome measure of the REF treatment.||123.69|92.54|
72473945|NCT02574845|144471985|SUPERIORITY_OR_OTHER_LEGACY||Adjusted geometric mean ratio T3/REF (%)|154.07|||||TWO_SIDED|90.0|131.7|180.24|||ANOVA|ANOVA model on the logarithmic scale including the effects: 'sequence', 'subjects within sequence', 'period' and 'treatment'.||This statistical analysis assess the effect of coadministration of 500 mg metformin hydrochloride on the primary outcome measure of the REF treatment.||180.24|131.70|
72473946|NCT02574845|144471985|SUPERIORITY_OR_OTHER_LEGACY||Adjusted geometric mean ratio T4/REF (%)|106.81|||||TWO_SIDED|90.0|91.78|124.3|||ANOVA|ANOVA model on the logarithmic scale including the effects: 'sequence', 'subjects within sequence', 'period' and 'treatment'.||This statistical analysis assess the effect of coadministration of 1 mg furosemide on the primary outcome measure of the REF treatment.||124.30|91.78|
72473947|NCT02574845|144471985|SUPERIORITY_OR_OTHER_LEGACY||Adjusted geometric mean ratio T5/REF (%)|117.98|||||TWO_SIDED|90.0|98.27|141.65|||ANOVA|ANOVA model on the logarithmic scale including the effects: 'sequence', 'subjects within sequence', 'period' and 'treatment'.||This statistical analysis assess the effect of coadministration of 5 mg furosemide on the primary outcome measure of the REF treatment.||141.65|98.27|
72473948|NCT02574845|144471986|SUPERIORITY_OR_OTHER_LEGACY||Adjusted geometric mean ratio T1/REF (%)|101.22|||||TWO_SIDED|90.0|89.23|114.82|||ANOVA|ANOVA model on the logarithmic scale including the effects: 'sequence', 'subjects within sequence', 'period' and 'treatment'.||This statistical analysis assess the effect of coadministration of 10 mg metformin hydrochloride on the primary outcome measure of the REF treatment.||114.82|89.23|
72507228|NCT03151148|144546497|SUPERIORITY||Geometric mean ratio (GMR)|1.23||||0.76|TWO_SIDED|95.0|0.327|4.617|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator.|"TMT vs Placebo on Non-lesional Skin at Day 8~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||4.617|0.327|0.760
72507229|NCT03151148|144546497|SUPERIORITY||Geometric mean ratio (GMR)|0.79||||0.713|TWO_SIDED|95.0|0.219|2.832|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator.|"TMT vs Placebo on Non-lesional Skin at Day 11~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||2.832|0.219|0.713
72507230|NCT03151148|144546498|SUPERIORITY||Geometric mean ratio (GMR)|12.08|||<|0.001|TWO_SIDED|95.0|3.524|41.435|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs Non-Lesional within TMT at Day 0~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||41.435|3.524|<0.001
72507231|NCT03151148|144546498|SUPERIORITY||Geometric mean ratio (GMR)|2.58||||0.131|TWO_SIDED|95.0|0.753|8.853|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs Non-Lesional within TMT at Day 4~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||8.853|0.753|0.131
72507232|NCT03151148|144546498|SUPERIORITY||Geometric mean ratio (GMR)|2.2||||0.21|TWO_SIDED|95.0|0.64|7.527|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs Non-Lesional within TMT at Day 7~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||7.527|0.640|0.210
72507233|NCT03151148|144546498|SUPERIORITY||Geometric mean ratio (GMR)|3.98||||0.031|TWO_SIDED|95.0|1.138|13.29|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs Non-Lesional within TMT at Day 8~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||13.290|1.138|0.031
72507234|NCT03151148|144546498|SUPERIORITY||Geometric mean ratio (GMR)|1.64||||0.429|TWO_SIDED|95.0|0.479|5.63|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs Non-Lesional within TMT at Day 11~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||5.630|0.479|0.429
72565892|NCT02139124|144662827|SUPERIORITY||Mean Difference (Final Values)|-2.1||||0.672|TWO_SIDED|95.0|-6.8|2.7||The model includes terms for treatment and baseline Clinician ADHD-5-RS score as a covariate.|ANCOVA|Analyses utilize ANCOVA models with Dunnett's adjustments for multiple pairwise comparisons for each active dose group with placebo.||"The null hypothesis is the mean Clinician ADHD-5-RS total score at Visit 6 is not different between the active treatment and placebo"||2.7|-6.8|0.6720
72565893|NCT02139124|144662827|SUPERIORITY||Mean Difference (Final Values)|-8.1||||0.0002|TWO_SIDED|95.0|-12.9|-3.2||The model include terms for treatment and baseline Clinician ADHD-5-RS score as a covariate.|ANCOVA|Analyses utilize ANCOVA models with Dunnett's adjustments for multiple pairwise comparisons for each active dose group with placebo.||"The null hypothesis is the mean Clinician ADHD-5-RS total score at Visit 6 is not different between the active treatment and placebo"||-3.2|-12.9|0.0002
72473949|NCT02574845|144471986|SUPERIORITY_OR_OTHER_LEGACY||Adjusted geometric mean ratio T2/REF (%)|107.26|||||TWO_SIDED|90.0|97.65|117.81|||ANOVA|ANOVA model on the logarithmic scale including the effects: 'sequence', 'subjects within sequence', 'period' and 'treatment'.||This statistical analysis assess the effect of coadministration of 50 mg metformin hydrochloride on the primary outcome measure of the REF treatment.||117.81|97.65|
72398327|NCT04483011|144303020|SUPERIORITY||Mean Difference (Net)|1.33|STANDARD_DEVIATION|1.88||0.04|TWO_SIDED|||||p \< 0.05|ANCOVA||The p value between RiaGev and Comparator groups at Day 5 over Day 1 is reported.|A comparison between RiaGev and Comparator supplementation.||||0.04
72473950|NCT02574845|144471986|SUPERIORITY_OR_OTHER_LEGACY||Adjusted geometric mean ratio T3/REF (%)|146.45|||||TWO_SIDED|90.0|135.21|158.62|||ANOVA|ANOVA model on the logarithmic scale including the effects: 'sequence', 'subjects within sequence', 'period' and 'treatment'.||This statistical analysis assess the effect of coadministration of 500 mg metformin hydrochloride on the primary outcome measure of the REF treatment.||158.62|135.21|
72473951|NCT02574845|144471986|SUPERIORITY_OR_OTHER_LEGACY||Adjusted geometric mean ratio T4/REF (%)|105.63|||||TWO_SIDED|90.0|92.2|121.0|||ANOVA|ANOVA model on the logarithmic scale including the effects: 'sequence', 'subjects within sequence', 'period' and 'treatment'.||This statistical analysis assess the effect of coadministration of 1 mg furosemide on the primary outcome measure of the REF treatment.||121.00|92.20|
72473952|NCT02574845|144471986|SUPERIORITY_OR_OTHER_LEGACY||Adjusted geometric mean ratio T5/REF (%)|118.1|||||TWO_SIDED|90.0|106.75|130.67|||ANOVA|ANOVA model on the logarithmic scale including the effects: 'sequence', 'subjects within sequence', 'period' and 'treatment'.||This statistical analysis assess the effect of coadministration of 5 mg furosemide on the primary outcome measure of the REF treatment.||130.67|106.75|
72473953|NCT04091061|144471998|OTHER|90% Confidence Intervals (CIs) for the ratios of adjusted geometric means (Test/Reference): Analysis 1: Mild Hepatic Impairment = Test, Without Hepatic Impairment = Reference|Ratio (%)|156.99|||||TWO_SIDED|90.0|83.14|296.44|||||90% CIs for the ratios of adjusted geometric means (Test/Reference): Analysis 1: Mild Hepatic Impairment = Test, Without Hepatic Impairment = Reference.|||296.44|83.14|
72473954|NCT04091061|144471998|OTHER|90% CIs for the ratios of adjusted geometric means (Test/Reference): Analysis 2: Moderate Hepatic Impairment = Test, Without Hepatic Impairment = Reference|Ratio (%)|125.58|||||TWO_SIDED|90.0|66.51|237.13|||||90% CIs for the ratios of adjusted geometric means (Test/Reference): Analysis 2: Moderate Hepatic Impairment = Test, Without Hepatic Impairment = Reference|||237.13|66.51|
72473955|NCT04091061|144471998|OTHER|90% CIs for the ratios of adjusted geometric means (Test/Reference): Analysis 3: Severe Hepatic Impairment = Test, Without Hepatic Impairment = Reference|Ratio (%)|123.75|||||TWO_SIDED|90.0|65.54|233.68|||||90% CIs for the ratios of adjusted geometric means (Test/Reference): Analysis 3: Severe Hepatic Impairment = Test, Without Hepatic Impairment = Reference|||233.68|65.54|
72473956|NCT04091061|144471999|OTHER|90% CIs for the ratios of adjusted geometric means (Test/Reference): Analysis 1: Mild Hepatic Impairment = Test, Without Hepatic Impairment = Reference|Ratio (%)|156.25|||||TWO_SIDED|90.0|81.07|301.16|||||90% CIs for the ratios of adjusted geometric means (Test/Reference): Analysis 1: Mild Hepatic Impairment = Test, Without Hepatic Impairment = Reference|||301.16|81.07|
72473957|NCT04091061|144471999|OTHER|90% CIs for the ratios of adjusted geometric means (Test/Reference): Analysis 2: Moderate Hepatic Impairment = Test, Without Hepatic Impairment = Reference|Ratio (%)|165.66|||||TWO_SIDED|90.0|85.95|319.29|||||90% CIs for the ratios of adjusted geometric means (Test/Reference): Analysis 2: Moderate Hepatic Impairment = Test, Without Hepatic Impairment = Reference|||319.29|85.95|
72473958|NCT04091061|144471999|OTHER|90% CIs for the ratios of adjusted geometric means (Test/Reference): Analysis 3: Severe Hepatic Impairment = Test, Without Hepatic Impairment = Reference|Ratio (%)|152.18|||||TWO_SIDED|90.0|78.96|293.32|||||90% CIs for the ratios of adjusted geometric means (Test/Reference): Analysis 3: Severe Hepatic Impairment = Test, Without Hepatic Impairment = Reference|||293.32|78.96|
72473959|NCT04091061|144472000|OTHER|90% CIs for the ratios of adjusted geometric means (Test/Reference): Analysis 1: Mild Hepatic Impairment = Test, Without Hepatic Impairment = Reference|Ratio (%)|156.0|||||TWO_SIDED|90.0|80.95|300.6|||||90% CIs for the ratios of adjusted geometric means (Test/Reference): Analysis 1: Mild Hepatic Impairment = Test, Without Hepatic Impairment = Reference|||300.60|80.95|
72473960|NCT04091061|144472000|OTHER|90% CIs for the ratios of adjusted geometric means (Test/Reference): Analysis 2: Moderate Hepatic Impairment = Test, Without Hepatic Impairment = Reference|Ratio (%)|165.38|||||TWO_SIDED|90.0|85.82|318.67|||||90% CIs for the ratios of adjusted geometric means (Test/Reference): Analysis 2: Moderate Hepatic Impairment = Test, Without Hepatic Impairment = Reference|||318.67|85.82|
72473961|NCT04091061|144472000|OTHER|90% CIs for the ratios of adjusted geometric means (Test/Reference): Analysis 3: Severe Hepatic Impairment = Test, Without Hepatic Impairment = Reference|Ratio (%)|152.2|||||TWO_SIDED|90.0|78.99|293.29|||||90% CIs for the ratios of adjusted geometric means (Test/Reference): Analysis 3: Severe Hepatic Impairment = Test, Without Hepatic Impairment = Reference|||293.29|78.99|
72473962|NCT03578887|144472040|SUPERIORITY||||||<|0.001|||||||ANOVA|||||||<0.001
72473963|NCT03578887|144472041|SUPERIORITY|||||||0.85|||||||ANOVA|||||||0.85
72473964|NCT05602727|144472062|SUPERIORITY|Difference in LS Means (MK-1942 - Placebo)|LS Mean Difference|2.1||||0.186|TWO_SIDED|97.5|-1.6|5.8|||Longitudinal ANCOVA|||||5.8|-1.6|0.186
72473965|NCT05602727|144472062|SUPERIORITY|Difference in LS Means (MK-1942 - Placebo)|LS Mean Difference|-1.4||||0.4|TWO_SIDED|97.5|-5.2|2.4|||Longitudinal ANCOVA|||||2.4|-5.2|0.400
72473966|NCT05602727|144472066|SUPERIORITY|Difference in LS Means|LS Mean Difference|-2.9||||0.196|TWO_SIDED|97.5|-8.0|2.2|||Longitudinal ANCOVA|||||2.2|-8.0|0.196
72473967|NCT05602727|144472066|SUPERIORITY|Difference in LS Means|LS Mean Difference|-4.2||||0.081|TWO_SIDED|97.5|-9.6|1.3|||Longitudinal ANCOVA|||||1.3|-9.6|0.081
72473968|NCT03268603|144472076|SUPERIORITY|||||||0.38|||||||Wilcoxon (Mann-Whitney)|||||||0.38
72473969|NCT03733314|144472113|SUPERIORITY||Difference|10.3|||||TWO_SIDED|95.0|-24.9|45.4|||||The difference of percentage was calculated as E6011 minus placebo.|||45.4|-24.9|
72473970|NCT03733314|144472118|SUPERIORITY||Difference|-7.1|||||TWO_SIDED|95.0|-32.1|18.0|||||The difference of percentage was calculated as E6011 minus placebo.|||18.0|-32.1|
72473971|NCT03733314|144472119|SUPERIORITY||Difference|8.3|||||TWO_SIDED|95.0|-7.3|24.0|||||The difference of percentage was calculated as E6011 minus placebo.|||24.0|-7.3|
72473972|NCT01240915|144472130|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.4|STANDARD_ERROR_OF_MEAN|0.223||0.96|TWO_SIDED|80.0|0.12|0.69||1-sided p-value|ANCOVA|||Pooled MultiStem versus Pooled Placebo||0.69|0.12|0.96
72473973|NCT01240915|144472131|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.161||0.54|TWO_SIDED|80.0|-0.19|0.22||1-sided p-value|Mixed Models Analysis|MMRM using data up to Week 8||Pooled MultiStem versus Pooled Placebo (Week 4)||0.22|-0.19|0.54
72473974|NCT01240915|144472132|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.08|STANDARD_ERROR_OF_MEAN|0.174||0.67|TWO_SIDED|80.0|-0.15|0.3||1-sided p-value|Mixed Models Analysis|MMRM using data up to Week 8||Pooled MultiStem versus Pooled Placebo (Week 8)||0.30|-0.15|0.67
72473975|NCT01240915|144472139|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.02||||0.53|TWO_SIDED|80.0|0.73|1.42||1-sided p-value|Mixed Models Analysis|MMRM using data up to Week 16||Pooled MultiStem versus Pooled Placebo (Week 4)||1.42|0.73|0.53
72565894|NCT02691741|144662828|NON_INFERIORITY|Non-inferiority is demonstrated if the upper confidence limit of the two-sided 90% confidence interval on the treatment difference is less than 0.1 logMAR unit.|Mean Difference (Final Values)|-0.061|STANDARD_ERROR_OF_MEAN|0.0193|||TWO_SIDED|90.0|-0.093|-0.029||||||||-0.029|-0.093|
72565895|NCT02691741|144662829|SUPERIORITY||Mean Difference (Final Values)|-0.061|STANDARD_ERROR_OF_MEAN|0.0193||0.002|TWO_SIDED|90.0|-0.093|-0.029|||Repeated Measures Analysis of Variance|||||-0.029|-0.093|0.002
72565896|NCT02691741|144662830|NON_INFERIORITY|Non-inferiority is demonstrated if the upper confidence limit of the two-sided 90% confidence interval on the treatment difference is less than 0.1 logMAR unit.|Mean Difference (Final Values)|0.012|STANDARD_ERROR_OF_MEAN|0.0157|||TWO_SIDED|95.0|-0.019|0.043||||||||0.043|-0.019|
72473976|NCT01240915|144472139|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.48||||0.91|TWO_SIDED|80.0|1.02|2.14||1-sided p-value|Mixed Models Analysis|MMRM using data up to Week 16||Pooled MultiStem versus Pooled Placebo (Week 8)||2.14|1.02|0.91
72473977|NCT01240915|144472139|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.38||||0.81|TWO_SIDED|80.0|0.86|2.23||1-sided p-value|Mixed Models Analysis|MMRM using data up to Week 16||Cohort 3 MM versus Cohort 3 PP (Week 12)||2.23|0.86|0.81
72473978|NCT01240915|144472139|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.94||||0.44|TWO_SIDED|80.0|0.59|1.51||1-sided p-value|Mixed Models Analysis|MMRM using data up to Week 16||Cohort 3 MP versus Cohort 3 PP (Week 12)||1.51|0.59|0.44
72473979|NCT01240915|144472139|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.18||||0.67|TWO_SIDED|80.0|0.72|1.94||1-sided p-value|Mixed Models Analysis|MMRM using data up to Week 16||Cohort 3 PM versus Cohort 3 PP (Week 12)||1.94|0.72|0.67
72473980|NCT01240915|144472139|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.12||||0.62|TWO_SIDED|80.0|0.68|1.84||1-sided p-value|Mixed Models Analysis|MMRM using data up to Week 16||Cohort 3 MM versus Cohort 3 PP (Week 16)||1.84|0.68|0.62
72473981|NCT01240915|144472139|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.95||||0.95|TWO_SIDED|80.0|0.58|1.57||1-sided p-value|Mixed Models Analysis|MMRM using data up to Week 16||Cohort 3 MP versus Cohort 3 PP (Week 16)||1.57|0.58|0.95
72473982|NCT01240915|144472139|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.81||||0.3|TWO_SIDED|80.0|0.49|1.36||1-sided p-value|Mixed Models Analysis|MMRM using data up to Week 16||Cohort 3 PM versus Cohort 3 PP (Week 16)||1.36|0.49|0.30
72473983|NCT01240915|144472140|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.17||||0.79|TWO_SIDED|80.0|0.91|1.51||1-sided p-value|Mixed Models Analysis|MMRM using data up to Week 16||Pooled MultiStem versus Pooled Placebo (Week 4)||1.51|0.91|0.79
72473984|NCT01240915|144472140|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.21||||0.8|TWO_SIDED|80.0|0.9|1.63||1-sided p-value|Mixed Models Analysis|MMRM using data up to Week 16||Pooled MultiStem versus Pooled Placebo (Week 8)||1.63|0.90|0.80
72473985|NCT01240915|144472140|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|2.75||||0.99|TWO_SIDED|80.0|1.63|4.64||1-sided p-value|Mixed Models Analysis|MMRM using data up to Week 16||Cohort 3 MM versus Cohort 3 PP (Week 12)||4.64|1.63|0.99
72473986|NCT01240915|144472140|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.96||||0.96|TWO_SIDED|80.0|1.19|3.25||1-sided p-value|Mixed Models Analysis|MMRM using data up to Week 16||Cohort 3 MP versus Cohort 3 PP (Week 12)||3.25|1.19|0.96
72473987|NCT01240915|144472140|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.98||||0.95|TWO_SIDED|80.0|1.15|3.41||1-sided p-value|Mixed Models Analysis|MMRM using data up to Week 16||Cohort 3 PM versus Cohort 3 PP (Week 12)||3.41|1.15|0.95
72473988|NCT01240915|144472140|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|2.3||||0.99|TWO_SIDED|80.0|1.52|3.48||1-sided p-value|Mixed Models Analysis|MMRM using data up to Week 16||Cohort 3 MM versus Cohort 3 PP (Week 16)||3.48|1.52|0.99
72473989|NCT01240915|144472140|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.1||||0.62|TWO_SIDED|80.0|0.74|1.63||1-sided p-value|Mixed Models Analysis|MMRM using data up to Week 16||Cohort 3 MP versus Cohort 3 PP (Week 16)||1.63|0.74|0.62
72473990|NCT01240915|144472140|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.51||||0.89|TWO_SIDED|80.0|0.98|2.32||1-sided p-value|Mixed Models Analysis|MMRM using data up to Week 16||Cohort 3 PM versus Cohort 3 PP (Week 16)||2.32|0.98|0.89
72473991|NCT01240915|144472141|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.21||||0.34|TWO_SIDED|80.0|0.66|2.19||1-sided p-value|Regression, Logistic|||Pooled MultiStem versus Pooled Placebo (Week 4)||2.19|0.66|0.34
72473992|NCT01240915|144472141|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.23||||0.33|TWO_SIDED|80.0|0.68|2.23||1-sided p-value|Regression, Logistic|||Pooled MultiStem versus Pooled Placebo (Week 8)||2.23|0.68|0.33
72473993|NCT01240915|144472141|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.37||||0.1|TWO_SIDED|80.0|0.99|5.67||1-sided p-value|Regression, Logistic|||Cohort 3 MM versus Cohort 3 PP (Week 12)||5.67|0.99|0.10
72473994|NCT01240915|144472141|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.66||||0.74|TWO_SIDED|80.0|0.28|1.55||1-sided p-value|Regression, Logistic|||Cohort 3 MP versus Cohort 3 PP (Week 12)||1.55|0.28|0.74
72473995|NCT01240915|144472141|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.04||||0.48|TWO_SIDED|80.0|0.41|2.64||1-sided p-value|Regression, Logistic|||Cohort 3 PM versus Cohort 3 PP (Week 12)||2.64|0.41|0.48
72473996|NCT01240915|144472141|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.88||||0.58|TWO_SIDED|80.0|0.38|2.03||1-sided p-value|Regression, Logistic|||Cohort 3 MM versus Cohort 3 PP (Week 16)||2.03|0.38|0.58
72473997|NCT01240915|144472141|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.74||||0.68|TWO_SIDED|80.0|0.33|1.66||1-sided p-value|Regression, Logistic|||Cohort 3 MP versus Cohort 3 PP (Week 16)||1.66|0.33|0.68
72473998|NCT01240915|144472141|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.51||||0.84|TWO_SIDED|80.0|0.21|1.23||1-sided p-value|Regression, Logistic|||Cohort 3 PM versus Cohort 3 PP (Week 16)||1.23|0.21|0.84
72565897|NCT02691741|144662830|SUPERIORITY|||||||0.455|||||||Repeated Measures Analysis of Variance|||||||0.455
72473999|NCT01240915|144472142|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.83||||0.57|TWO_SIDED|80.0|0.22|3.07||1-sided p-value|Regression, Logistic|||Pooled MultiStem versus Pooled Placebo||3.07|0.22|0.57
72474000|NCT01240915|144472143|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.39||||0.85|TWO_SIDED|80.0|0.12|1.23||1-sided p-value|Regression, Logistic|||Pooled MultiStem versus Pooled Placebo||1.23|0.12|0.85
72474001|NCT01240915|144472144|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.27||||0.05|TWO_SIDED|80.0|1.21|4.24||1-sided p-value|Regression, Logistic|||Pooled MultiStem versus Pooled Placebo (Week 4)||4.24|1.21|0.05
72474002|NCT01240915|144472144|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.09||||0.43|TWO_SIDED|80.0|0.61|1.95||1-sided p-value|Regression, Logistic|||Pooled MultiStem versus Pooled Placebo (Week 8)||1.95|0.61|0.43
72474003|NCT01240915|144472144|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.11||||0.44|TWO_SIDED|80.0|0.45|2.76||1-sided p-value|Regression, Logistic|||Cohort 3 MM versus Cohort 3 PP (Week 12)||2.76|0.45|0.44
72474004|NCT01240915|144472144|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.23||||0.38|TWO_SIDED|80.0|0.5|3.04||1-sided p-value|Regression, Logistic|||Cohort 3 MP versus Cohort 3 PP (Week 12)||3.04|0.50|0.38
72474005|NCT01240915|144472144|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.38||||0.89|TWO_SIDED|80.0|0.14|1.04||1-sided p-value|Regression, Logistic|||Cohort 3 PM versus Cohort 3 PP (Week 12)||1.04|0.14|0.89
72474006|NCT01240915|144472144|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.05||||0.47|TWO_SIDED|80.0|0.45|2.42||1-sided p-value|Regression, Logistic|||Cohort 3 MM versus Cohort 3 PP (Week 16)||2.42|0.45|0.47
72474007|NCT01240915|144472144|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.58||||0.24|TWO_SIDED|80.0|0.7|3.57||1-sided p-value|Regression, Logistic|||Cohort 3 MP versus Cohort 3 PP (Week 16)||3.57|0.70|0.24
72474008|NCT01240915|144472144|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.53||||0.81|TWO_SIDED|80.0|0.22|1.32||1-sided p-value|Regression, Logistic|||Cohort 3 PM versus Cohort 3 PP (Week 16)||1.32|0.22|0.81
72474009|NCT01240915|144472145|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.49||||0.84|TWO_SIDED|80.0|0.2|1.24||1-sided p-value|Regression, Logistic|||Pooled MultiStem versus Pooled Placebo||1.24|0.20|0.84
72474010|NCT01240915|144472146|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.3||||0.96|TWO_SIDED|80.0|0.12|0.73||1-sided p-value|Regression, Logistic|||Pooled MultiStem versus Pooled Placebo||0.73|0.12|0.96
72474011|NCT01240915|144472147|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.58|STANDARD_ERROR_OF_MEAN|0.513||0.87|TWO_SIDED|80.0|-0.08|1.24||1-sided p-value|ANCOVA|||Pooled MultiStem versus Pooled Placebo||1.24|-0.08|0.87
72474012|NCT01240915|144472148|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.29|STANDARD_ERROR_OF_MEAN|0.345||0.8|TWO_SIDED|80.0|-0.15|0.74||1-sided p-value|Mixed Models Analysis|MMRM using data up to Week 16||Pooled MultiStem versus Pooled Placebo (Week 4)||0.74|-0.15|0.80
72474013|NCT01240915|144472148|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3|STANDARD_ERROR_OF_MEAN|0.418||0.77|TWO_SIDED|80.0|-0.23|0.84||1-sided p-value|Mixed Models Analysis|MMRM using data up to Week 16||Pooled MultiStem versus Pooled Placebo (Week 8)||0.84|-0.23|0.77
72474014|NCT01240915|144472148|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.44|STANDARD_ERROR_OF_MEAN|0.666||0.74|TWO_SIDED|80.0|-0.42|1.3||1-sided p-value|Mixed Models Analysis|MMRM using data up to Week 16||Cohort 3 MM versus Cohort 3 PP (Week 12)||1.30|-0.42|0.74
72474015|NCT01240915|144472148|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.76|STANDARD_ERROR_OF_MEAN|0.645||0.88|TWO_SIDED|80.0|-0.08|1.59||1-sided p-value|Mixed Models Analysis|MMRM using data up to Week 16||Cohort 3 MP versus Cohort 3 PP (Week 12)||1.59|-0.08|0.88
72474016|NCT01240915|144472148|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.42|STANDARD_ERROR_OF_MEAN|0.705||0.72|TWO_SIDED|80.0|-0.5|1.33||1-sided p-value|Mixed Models Analysis|MMRM using data up to Week 16||Cohort 3 PM versus Cohort 3 PP (Week 12)||1.33|-0.50|0.72
72474017|NCT01240915|144472148|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.21|STANDARD_ERROR_OF_MEAN|0.656||0.97|TWO_SIDED|80.0|0.37|2.06||1-sided p-value|Mixed Models Analysis|MMRM using data up to Week 16||Cohort 3 MM versus Cohort 3 PP (Week 16)||2.06|0.37|0.97
72474018|NCT01240915|144472148|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.43|STANDARD_ERROR_OF_MEAN|0.635||0.75|TWO_SIDED|80.0|-0.39|1.25||1-sided p-value|Mixed Models Analysis|MMRM using data up to Week 16||Cohort 3 MP versus Cohort 3 PP (Week 16)||1.25|-0.39|0.75
72474019|NCT01240915|144472148|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.73|STANDARD_ERROR_OF_MEAN|0.692||0.85|TWO_SIDED|80.0|-0.16|1.63||1-sided p-value|Mixed Models Analysis|MMRM using data up to Week 16||Cohort 3 PM versus Cohort 3 PP (Week 16)||1.63|-0.16|0.85
72474020|NCT01240915|144472149|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.52|STANDARD_ERROR_OF_MEAN|0.753||0.75|TWO_SIDED|80.0|-0.46|1.49||1-sided p-value|ANCOVA|||Pooled MultiStem versus Pooled Placebo||1.49|-0.46|0.75
72474021|NCT01240915|144472150|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.144||0.51|TWO_SIDED|80.0|-0.18|0.19||1-sided p-value|Mixed Models Analysis|MMRM using data up to Week 16||Pooled MultiStem versus Pooled Placebo (Week 4)||0.19|-0.18|0.51
72474022|NCT01240915|144472150|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.158||0.62|TWO_SIDED|80.0|-0.16|0.25||1-sided p-value|Mixed Models Analysis|MMRM using data up to Week 16||Pooled MultiStem versus Pooled Placebo (Week 8)||0.25|-0.16|0.62
72474023|NCT01240915|144472150|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.12|STANDARD_ERROR_OF_MEAN|0.213||0.29|TWO_SIDED|80.0|-0.39|0.16||1-sided p-value|Mixed Models Analysis|MMRM using data up to Week 16||Cohort 3 MM versus Cohort 3 PP (Week 12)||0.16|-0.39|0.29
72474024|NCT01240915|144472150|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.13|STANDARD_ERROR_OF_MEAN|0.209||0.74|TWO_SIDED|80.0|-0.14|0.4||1-sided p-value|Mixed Models Analysis|MMRM using data up to Week 16||Cohort 3 MP versus Cohort 3 PP (Week 12)||0.40|-0.14|0.74
72474025|NCT01240915|144472150|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.08|STANDARD_ERROR_OF_MEAN|0.226||0.36|TWO_SIDED|80.0|-0.37|0.21||1-sided p-value|Mixed Models Analysis|MMRM using data up to Week 16||Cohort 3 PM versus Cohort 3 PP (Week 12)||0.21|-0.37|0.36
72474026|NCT01240915|144472150|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.04|STANDARD_ERROR_OF_MEAN|0.234||0.56|TWO_SIDED|80.0|-0.26|0.34||1-sided p-value|Mixed Models Analysis|MMRM using data up to Week 16||Cohort 3 MM versus Cohort 3 PP (Week 16)||0.34|-0.26|0.56
72474027|NCT01240915|144472150|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.21|STANDARD_ERROR_OF_MEAN|0.231||0.18|TWO_SIDED|80.0|-0.51|0.09||1-sided p-value|Mixed Models Analysis|MMRM using data up to Week 16||Cohort 3 MP versus Cohort 3 PP (Week 16)||0.09|-0.51|0.18
72474028|NCT01240915|144472150|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.12|STANDARD_ERROR_OF_MEAN|0.25||0.31|TWO_SIDED|80.0|-0.45|0.2||1-sided p-value|Mixed Models Analysis|MMRM using data up to Week 16||Cohort 3 PM versus Cohort 3 PP (Week 16)||0.20|-0.45|0.31
72474029|NCT04514510|144472151|SUPERIORITY|||||||0.64|||||||ANCOVA with Multiple Imputation|||||||0.64
72474030|NCT04514510|144472157|SUPERIORITY|||||||0.149|||||||Wilcoxon (Mann-Whitney)|||||||0.149
72474031|NCT00406692|144472161|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.7|STANDARD_ERROR_OF_MEAN|1.5|<|0.0003|TWO_SIDED|95.0||||Null Hypothesis: No difference in the mean daily standard drinks consumed for the baseline period and the zonisamide treatment weeks|Mixed Models Analysis|||Null Hypothesis: No difference in the mean daily standard drinks consumed between the baseline period and the zonisamide treatment weeks.||||<0.0003
72474032|NCT00406692|144472162|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-6.7|STANDARD_ERROR_OF_MEAN|3.9|<|0.22|TWO_SIDED|95.0|||||Mixed Models Analysis|||Null Hypothesis: No significant change in the mean number of words produced during phonetic portion of the Controlled Word Association Test between the baseline period and the treatment weeks.||||<0.22
72474033|NCT00406692|144472163|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.5|STANDARD_ERROR_OF_MEAN|4.0|<|0.55|TWO_SIDED|95.0|||||Mixed Models Analysis|||Null Hypothesis: No significant difference for mean scores obtained for baseline, week 4 and week 12.||||< 0.55
72474034|NCT00821587|144472164|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05|TWO_SIDED|95.0||||We hypothesize that subjects on CsA are more likely to achieve undetectable viral level in patients receiving antiviral therapy for recurrent HCV after Liver Transplant|Chi-squared|||We hypothesize that subjects on CsA are more likely to achieve undetectable viral levels after liver transplant. Comparisons between the two groups (Undetectable viral level vs. Detectable viral level) were performed with Pearson Chi-square tests or Fisher's exact test for categorical variables, and Mann-Whitney U test for continuous variables.||||<0.05
72474035|NCT01145898|144472171|SUPERIORITY_OR_OTHER|||||||0.6261||95.0|||||ANCOVA|||There will be (as shown) differences in the number of subjects based upon the time of analysis due to patient loss, data of insufficient quality at visit, or change in the drug use during period of study (patient switched off treatment by their doctor) so the number of data points varies throughout the analysis by availability.||||.6261
72474036|NCT01145898|144472172|SUPERIORITY_OR_OTHER|||||||0.6081||95.0|||||ANCOVA|||||||.6081
72474037|NCT01145898|144472173|SUPERIORITY_OR_OTHER|||||||0.1822||95.0|||||ANCOVA|||||||.1822
72474038|NCT01145898|144472174|SUPERIORITY_OR_OTHER|||||||0.2383||95.0|||||ANCOVA|||||||.2383
72474039|NCT01145898|144472175|SUPERIORITY_OR_OTHER|||||||0.2383||95.0|||||ANCOVA|||||||.2383
72474040|NCT01145898|144472176|SUPERIORITY_OR_OTHER|||||||0.1564||95.0|||||ANCOVA|||||||.1564
72507235|NCT03151148|144546498|SUPERIORITY||Geometric mean ratio (GMR)|9.26||||0.01|TWO_SIDED|95.0|1.712|50.043|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs Non-Lesional within Placebo at Day 0~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||50.043|1.712|0.010
72474041|NCT01145898|144472177|SUPERIORITY_OR_OTHER|||||||0.2265||95.0|||||ANCOVA|||||||.2265
72474042|NCT01145898|144472178|SUPERIORITY_OR_OTHER|||||||0.4645||95.0|||||ANCOVA|||||||.4645
72474043|NCT01145898|144472179|SUPERIORITY_OR_OTHER|||||||0.5998||95.0|||||ANCOVA|||||||.5998
72474044|NCT01145898|144472180|SUPERIORITY_OR_OTHER|||||||0.8119||95.0|||||ANCOVA|||||||.8119
72474045|NCT01145898|144472181|SUPERIORITY_OR_OTHER|||||||0.1319||95.0|||||ANCOVA|||||||.1319
72474046|NCT01145898|144472182|SUPERIORITY_OR_OTHER|||||||0.0199||95.0|||||ANCOVA|||||||.0199
72474047|NCT01145898|144472183|SUPERIORITY_OR_OTHER|||||||0.7597||95.0|||||ANCOVA|||||||.7597
72474048|NCT01145898|144472184|SUPERIORITY_OR_OTHER|||||||0.2528||95.0|||||ANCOVA|||||||.2528
72474049|NCT01712061|144472185|SUPERIORITY_OR_OTHER||Ratio of geometric mean changes|0.92|||||TWO_SIDED|95.0|0.75|1.09|||ANCOVA|Bayesian ANCOVA with covariates for baseline UACR and systolic blood pressure (SBP).||||1.09|0.75|
72474050|NCT02278484|144472214|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
72474051|NCT01401153|144472216|NON_INFERIORITY_OR_EQUIVALENCE|Power calculation based on parallel group design --\> revealed that 68 children are needed to detect a difference of 45ms in the mean reaction time between the groups, with α=.05 and a power of 0.8.||||||0.79|||||||Wilcoxon (Mann-Whitney)|Individual differences of both test days compared on group level (having lunch/skipping lunch vs. skipping lunch/having lunch)||Power calculation had been performed.||||0.79
72474052|NCT01401153|144472217|NON_INFERIORITY_OR_EQUIVALENCE|No power calculation had been performed based on this measure||||||0.07|||||||Wilcoxon (Mann-Whitney)|Individual differences of both test days compared on group level (having lunch/skipping lunch vs. skipping lunch/having lunch)||||||0.07
72474053|NCT01401153|144472218|NON_INFERIORITY_OR_EQUIVALENCE|No power calculation had been performed based on this measure||||||0.61|||||||Wilcoxon (Mann-Whitney)|Individual differences of both test days compared on group level (having lunch/skipping lunch vs. skipping lunch/having lunch)||||||0.61
72474054|NCT01401153|144472219|NON_INFERIORITY_OR_EQUIVALENCE|No power calculation had been perfomed based on this measure||||||0.03|||||||Wilcoxon (Mann-Whitney)|Individual differences of both test days compared on group level (having lunch/skipping lunch vs. skipping lunch/having lunch)||||||0.03
72474055|NCT01401153|144472220|NON_INFERIORITY_OR_EQUIVALENCE|No power calculation had been performed based on this measure||||||0.25|||||||Generalized linear models|The fixed statement considered treatment, test day and the interaction between treatment and test day||||||0.25
72474056|NCT01401153|144472221|NON_INFERIORITY_OR_EQUIVALENCE|No power calculation had been performed based on this measure||||||0.7|||||||Generalized linear models|||||||0.70
72474057|NCT01401153|144472222|NON_INFERIORITY_OR_EQUIVALENCE|No power calculation had been performed based on this measure||||||0.33|||||||Generalized linear models|||||||0.33
72474058|NCT01401153|144472223|NON_INFERIORITY_OR_EQUIVALENCE|No power calculation had been performed based on this measure||||||0.63|||||||Generalized linear models|||||||0.63
72474059|NCT01401153|144472224|NON_INFERIORITY_OR_EQUIVALENCE|No power calculation had been performed based on this measure||||||0.62|||||||Wilcoxon (Mann-Whitney)|Individual differences of both test days compared on group level (having lunch/skipping lunch vs. skipping lunch/having lunch)||||||0.62
72474060|NCT01401153|144472225|NON_INFERIORITY_OR_EQUIVALENCE|No power calculation had been performed based on this measure||||||0.11|||||||Wilcoxon (Mann-Whitney)|Individual differences of both test days compared on group level (having lunch/skipping lunch vs. skipping lunch/having lunch)||||||0.11
72474061|NCT01401153|144472226|NON_INFERIORITY_OR_EQUIVALENCE|No power calculation had been performed based on this measure||||||0.45|||||||t-test, 2 sided|Individual differences of both test days compared on group level (having lunch/skipping lunch vs. skipping lunch/having lunch)||||||0.45
72474062|NCT01401153|144472227|NON_INFERIORITY_OR_EQUIVALENCE|No power calculation had been performed based on this measure||||||0.13|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|Individual differences of both test days compared on group level (having lunch/skipping lunch vs. skipping lunch/having lunch)||||||0.13
72474063|NCT01401153|144472228|NON_INFERIORITY_OR_EQUIVALENCE|No power calculation had been performed based on this measure||||||0.68|||||||Wilcoxon (Mann-Whitney)|Individual differences of both test days compared on group level (having lunch/skipping lunch vs. skipping lunch/having lunch)||||||0.68
72474064|NCT01401153|144472229|NON_INFERIORITY_OR_EQUIVALENCE|No power calculation had been performed based on this measure||||||0.67|||||||Wilcoxon (Mann-Whitney)|Individual differences of both test days compared on group level (having lunch/skipping lunch vs. skipping lunch/having lunch)||||||0.67
72474065|NCT03846453|144472261|SUPERIORITY||Least Squares (LS) Mean Difference|0.08|STANDARD_ERROR_OF_MEAN|0.064||0.1871|TWO_SIDED|95.0|-0.04|0.21||P-value calculated using a model with treatment, baseline score, and site as covariates.|ANCOVA|||||0.21|-0.04|0.1871
72474066|NCT03846453|144472262|SUPERIORITY||LS Mean Difference|0.05|STANDARD_ERROR_OF_MEAN|0.09||0.5549|TWO_SIDED|95.0|-0.12|0.23|||ANCOVA|P-value calculated using a model with treatment, baseline score, and site as covariates.||||0.23|-0.12|0.5549
72474067|NCT00368927|144472362|SUPERIORITY_OR_OTHER|||||||0.85||95.0|||||Fisher Exact|||With a sample size of 60 evaluable participants per intervention arm, we would have 90% power to detect a bronchial dysplasia response rate of 54% and 82% power to detect a bronchial dysplasia response rate of\> 51% among participants assigned to receive active sulindac (2-sided chi-square test with continuity correction; alpha=0.05).||||0.85
72474068|NCT00368927|144472363|SUPERIORITY_OR_OTHER|||||||0.63||95.0|||||t-test, 2 sided|||A sample size of 60 participants per intervention arm would provide 90% power and 80% power to detect effect sizes of 60% and 52%, respectively, using a two-sample t-test(alpha=0.05).||||0.63
72507236|NCT03151148|144546498|SUPERIORITY||Geometric mean ratio (GMR)|3.45||||0.15|TWO_SIDED|95.0|0.637|18.627|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs Non-Lesional within Placebo at Day 4~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||18.627|0.637|0.150
72542453|NCT00106028|144614672|SUPERIORITY_OR_OTHER||Mean Difference (Net)|10.333|||<|0.0001||95.0|5.258|15.408|||ANCOVA|LS Means and p-value are from ANCOVA model adjusted by baseline and with fixed effects for age group, treatment and pooled center for post-baseline.||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.||15.408|5.258|<0.0001
72474069|NCT02229851|144472394|SUPERIORITY||Treatment difference|-1.53|||=|0.009|TWO_SIDED|95.0|-2.68|-0.38|||ANCOVA||Somapacitan-Placebo|Changes in truncal fat percentage from baseline to the 34 week's measurements was analysed using an analysis of covariance model with treatment, growth hormone deficiency (GHD) onset type, sex, region, diabetes mellitus (DM) and sex by region by DM interaction as factors and baseline as a covariate. The analysis was conducted using a multiple imputation technique where trajectory after a withdrawn subjects last observation was imputed based on data from the placebo arm.||-0.38|-2.68|=0.0090
72474070|NCT01607476|144472534|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
72474071|NCT01607476|144472534|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
72474072|NCT01607476|144472534|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
72474073|NCT01607476|144472535|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
72474074|NCT01607476|144472535|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
72474075|NCT01607476|144472535|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
72474076|NCT02299414|144472536|SUPERIORITY||Risk Ratio (RR)|0.82|||<|0.001|TWO_SIDED|95.0|0.73|0.92|||Chi-squared|||||.92|.73|<0.001
72474077|NCT02299414|144472536|SUPERIORITY||Risk Ratio (RR)|0.8|||||TWO_SIDED|95.0|0.7|0.9||||||||.90|.70|
72474078|NCT02299414|144472536|SUPERIORITY||Risk Ratio (RR)|0.73|||||TWO_SIDED|95.0|0.6|0.89||||||||.89|.60|
72474079|NCT02299414|144472536|SUPERIORITY||Risk Ratio (RR)|0.9|||||TWO_SIDED|95.0|0.49|1.64||||||||1.64|.49|
72474080|NCT02299414|144472536|SUPERIORITY||Risk Ratio (RR)|0.81|||||TWO_SIDED|95.0|0.54|1.21||||||||1.21|.54|
72474081|NCT02299414|144472537|SUPERIORITY||Risk Ratio (RR)|1.07||||0.56|TWO_SIDED|95.0|0.85|1.36|||Chi-squared|||||1.36|0.85|0.56
72474082|NCT02299414|144472538|SUPERIORITY||Risk Ratio (RR)|0.75|||||TWO_SIDED|95.0|0.45|1.26||||||||1.26|.45|
72474083|NCT02299414|144472539|SUPERIORITY||Risk Ratio (RR)|0.83|||||TWO_SIDED|95.0|0.77|0.91||||||||0.91|0.77|
72474084|NCT02299414|144472540|SUPERIORITY||Risk Ratio (RR)|0.87|||||TWO_SIDED|95.0|0.77|0.99||||||||.99|.77|
72474085|NCT02299414|144472541|SUPERIORITY||Risk Ratio (RR)|0.77|||||TWO_SIDED|95.0|0.45|1.3||||||||1.3|.45|
72474086|NCT02299414|144472542|SUPERIORITY||Risk Ratio (RR)|1.08|||||TWO_SIDED|95.0|0.98|1.18||||||||1.18|.98|
72474087|NCT02299414|144472543|SUPERIORITY||Risk Ratio (RR)|0.79|||||TWO_SIDED|95.0|0.69|0.89||||||||.89|.69|
72474088|NCT02299414|144472544|SUPERIORITY||Risk Ratio (RR)|0.84|||||TWO_SIDED|95.0|0.68|1.04||||||||1.04|0.68|
72474089|NCT02299414|144472545|SUPERIORITY||Risk Ratio (RR)|0.82|||||TWO_SIDED|95.0|0.74|0.9||||||||.90|.74|
72474090|NCT02299414|144472546|SUPERIORITY||Risk Ratio (RR)|1.01|||||TWO_SIDED|95.0|0.93|1.1||||||||1.10|.93|
72398328|NCT04483011|144303021|SUPERIORITY||Mean Difference (Net)|4.01|STANDARD_DEVIATION|6.57||0.004|TWO_SIDED|||||p \< 0.05|Wilcoxon (Mann-Whitney)||The p value in the RiaGev group at Day 5 over Day 1 is reported.|A comparison between before and after RiaGev supplementation.||||0.004
72398329|NCT04483011|144303021|SUPERIORITY||Mean Difference (Net)|0.4|STANDARD_DEVIATION|3.88||0.64|TWO_SIDED|||||p \> 0.05|Wilcoxon (Mann-Whitney)||The p value in Comparator group at Day 5 over Day 1 is reported.|A comparison between before and after supplementation with Comparator.||||0.640
72474091|NCT02299414|144472547|SUPERIORITY||Risk Ratio (RR)|0.86|||||TWO_SIDED|95.0|0.59|1.27||||||||1.27|.59|
72474092|NCT02299414|144472548|SUPERIORITY||Risk Ratio (RR)|0.91|||||TWO_SIDED|95.0|0.81|1.02||||||||1.02|.81|
72474093|NCT02299414|144472549|SUPERIORITY||Risk Ratio (RR)|0.83|||||TWO_SIDED|95.0|0.71|0.97||||||||.97|.71|
72474094|NCT02299414|144472550|SUPERIORITY||Mean Difference (Final Values)|0.16|||||TWO_SIDED|95.0|-0.11|0.43||||||||0.43|-0.11|
72474095|NCT02299414|144472551|SUPERIORITY||Mean Difference (Final Values)|0.31|||||TWO_SIDED|95.0|0.05|0.56||||||||0.56|0.05|
72474096|NCT02299414|144472552|SUPERIORITY||Mean Difference (Final Values)|1.7|||||TWO_SIDED|95.0|-17.6|20.9||||||||20.9|-17.6|
72474097|NCT02299414|144472553|SUPERIORITY||Risk Ratio (RR)|0.97|||||TWO_SIDED|95.0|0.81|1.17||||||||1.17|.81|
72474098|NCT02299414|144472554|SUPERIORITY||Risk Ratio (RR)|0.88|||||TWO_SIDED|95.0|0.55|1.42||||||||1.42|.55|
72474099|NCT02299414|144472555|SUPERIORITY||Risk Ratio (RR)|0.43|||||TWO_SIDED|95.0|0.18|1.05||||||||1.05|.18|
72474100|NCT02299414|144472556|SUPERIORITY||Risk Ratio (RR)|0.87|||||TWO_SIDED|95.0|0.71|1.06||||||||1.06|.71|
72474101|NCT02299414|144472557|SUPERIORITY||Risk Ratio (RR)|0.57|||||TWO_SIDED|95.0|0.24|1.35||||||||1.35|.24|
72474102|NCT02299414|144472558|SUPERIORITY||Risk Ratio (RR)|0.98|||||TWO_SIDED|95.0|0.85|1.12||||||||1.12|.85|
72474103|NCT02299414|144472559|SUPERIORITY||Risk Ratio (RR)|0.64|||||TWO_SIDED|95.0|0.3|1.37||||||||1.37|0.30|
72474104|NCT02299414|144472560|SUPERIORITY||Risk Ratio (RR)|0.99|||||TWO_SIDED|95.0|0.14|7.06||||||||7.06|.14|
72474105|NCT02299414|144472561|SUPERIORITY||Risk Ratio (RR)|0.93|||||TWO_SIDED|95.0|0.81|1.08||||||||1.08|.81|
72474106|NCT02299414|144472562|SUPERIORITY||Risk Ratio (RR)|0.84|||||TWO_SIDED|95.0|0.62|1.16||||||||1.16|0.62|
72474107|NCT02299414|144472563|SUPERIORITY||Risk Ratio (RR)|0.61|||||TWO_SIDED|95.0|0.36|1.05||||||||1.05|.36|
72474108|NCT02299414|144472564|SUPERIORITY||Mean Difference (Final Values)|-0.1|||||TWO_SIDED|95.0|-0.2|0.03||||||||0.03|-0.2|
72474109|NCT02299414|144472565|SUPERIORITY||Mean Difference (Final Values)|-0.01|||||TWO_SIDED|95.0|-0.1|0.1||||||||0.1|-0.1|
72474110|NCT02299414|144472566|SUPERIORITY||Mean Difference (Final Values)|-0.06|||||TWO_SIDED|95.0|-0.12|0.002||||||||0.002|-0.12|
72474111|NCT02299414|144472567|SUPERIORITY||Mean Difference (Final Values)|0.01|||||TWO_SIDED|95.0|-0.02|0.04||||||||0.04|-0.02|
72474112|NCT02299414|144472568|SUPERIORITY||Risk Ratio (RR)|0.98|||||TWO_SIDED|95.0|0.9|1.06||||||||1.06|0.90|
72474113|NCT04655027|144472600|OTHER|Treatment effect|Difference in Estimate (LSM)|19.5|STANDARD_ERROR_OF_MEAN|15.62||0.212|TWO_SIDED|95.0|-11.155|50.15|||ANCOVA|||||50.150|-11.155|0.212
72474114|NCT04655027|144472601|OTHER|Baseline hepcidin by treatment effect|Difference in Estimate|-0.13|STANDARD_ERROR_OF_MEAN|0.17||0.441|TWO_SIDED|95.0|-0.477|0.208|||ANCOVA|||||0.208|-0.477|0.441
72474115|NCT04655027|144472601|OTHER|Baseline hs CRP by treatment effect|Difference in Estimates|-2.34|STANDARD_ERROR_OF_MEAN|3.76||0.532|TWO_SIDED|95.0|-9.707|5.017|||ANCOVA|||||5.017|-9.707|0.532
72474116|NCT04655027|144472602|OTHER|Treatment effect|Ratio of Estimates|1.09|STANDARD_ERROR_OF_MEAN|1.23||0.688|TWO_SIDED|95.0|0.723|1.635|||Geometric ANCOVA|Geometric ANCOVA of relative change from baseline. The Standard error of Mean (SEM) refers to Geometric SEM.||||1.635|0.723|0.688
72474117|NCT04655027|144472602|OTHER|Baseline hepcidin-by-treatment effect|Difference in Estimates|0.43|STANDARD_ERROR_OF_MEAN|0.2||0.029|TWO_SIDED|95.0|0.045|0.822|||ANCOVA|||||0.822|0.045|0.029
72474118|NCT04655027|144472602|OTHER|Baseline hs-CRP-by-treatment effect|Difference in Estimates|0.08|STANDARD_ERROR_OF_MEAN|0.14||0.568|TWO_SIDED|95.0|-0.201|0.366|||ANCOVA|||||0.366|-0.201|0.568
72474119|NCT04655027|144472603|OTHER|Treatment effect|Ratio of Estimates|0.84|STANDARD_ERROR_OF_MEAN|1.11||0.096|TWO_SIDED|95.0|0.687|1.031|||Geometric ANCOVA|Geometric ANCOVA of relative change from baseline. The Standard error of Mean (SEM) refers to Geometric SEM.||||1.031|0.687|0.096
72474120|NCT04655027|144472603|OTHER|Baseline hepcidin-by-treatment effect|Difference in Estimates|-0.06|STANDARD_ERROR_OF_MEAN|0.12||0.63|TWO_SIDED|95.0|-0.282|0.171|||ANCOVA|||||0.171|-0.282|0.630
72474121|NCT04655027|144472603|OTHER|Baseline hs-CRP-by-treatment effect|Difference in Estimates|0.19|STANDARD_ERROR_OF_MEAN|0.08||0.015|TWO_SIDED|95.0|0.037|0.342|||ANCOVA|||||0.342|0.037|0.015
72474122|NCT04655027|144472604|OTHER|Treatment effect|Ratio of Estimates|1.23|STANDARD_ERROR_OF_MEAN|1.05|<|0.001|TWO_SIDED|95.0|1.123|1.354|||Geometric ANCOVA|Geometric ANCOVA of relative change from baseline. The Standard error of Mean (SEM) refers to Geometric SEM.||||1.354|1.123|< 0.001
72474123|NCT04655027|144472604|OTHER|Baseline hepcidin-by-treatment effect|Difference in Estimates|0.06|STANDARD_ERROR_OF_MEAN|0.04||0.171|TWO_SIDED|95.0|-0.027|0.149|||ANCOVA|||||0.149|-0.027|0.171
72474124|NCT04655027|144472604|OTHER|Baseline hs-CRP-by-treatment effect|Difference in Estimates|0.03|STANDARD_ERROR_OF_MEAN|0.04||0.387|TWO_SIDED|95.0|-0.039|0.101|||ANCOVA|||||0.101|-0.039|0.387
72474125|NCT04655027|144472605|OTHER|Treatment effect|Ratio of Estimates|0.89|STANDARD_ERROR_OF_MEAN|1.22||0.561|TWO_SIDED|95.0|0.606|1.312|||Geometric ANCOVA|Geometric ANCOVA of relative change from baseline. The Standard error of Mean (SEM) refers to Geometric SEM.||||1.312|0.606|0.561
72474126|NCT04655027|144472605|OTHER|Baseline hepcidin-by-treatment effect|Difference in Estimates|0.38|STANDARD_ERROR_OF_MEAN|0.19||0.043|TWO_SIDED|95.0|0.013|0.75|||ANCOVA|||||0.750|0.013|0.043
72474127|NCT04655027|144472605|OTHER|Baseline hs-CRP-by-treatment effect|Difference in Estimates|0.04|STANDARD_ERROR_OF_MEAN|0.13||0.766|TWO_SIDED|95.0|-0.222|0.302|||ANCOVA|||||0.302|-0.222|0.766
72474128|NCT04655027|144472606|OTHER|Treatment effect|Ratio of Estimates|1.23|STANDARD_ERROR_OF_MEAN|1.05|<|0.001|TWO_SIDED|95.0|1.108|1.369|||Geometric ANCOVA|Geometric ANCOVA of relative change from baseline. The Standard error of Mean (SEM) refers to Geometric SEM.||||1.369|1.108|< 0.001
72474129|NCT04655027|144472606|OTHER|Baseline hepcidin-by-treatment effect|Difference in Estimates|0.05|STANDARD_ERROR_OF_MEAN|0.05||0.351|TWO_SIDED|95.0|-0.059|0.159|||ANCOVA|||||0.159|-0.059|0.351
72474130|NCT04655027|144472606|OTHER|Baseline hs-CRP-by-treatment effect|Difference in Estimates|0.04|STANDARD_ERROR_OF_MEAN|0.03||0.248|TWO_SIDED|95.0|-0.031|0.114|||ANCOVA|||||0.114|-0.031|0.248
72474131|NCT04655027|144472607|OTHER|Treatment effect|Ratio of Estimates|1.29|STANDARD_ERROR_OF_MEAN|1.11||0.021|TWO_SIDED|95.0|1.043|1.598|||Geometric ANCOVA|Geometric ANCOVA of relative change from baseline. The Standard error of Mean (SEM) refers to Geometric SEM.||||1.598|1.043|0.021
72474132|NCT04655027|144472607|OTHER|Baseline hepcidin-by-treatment effect|Difference in Estimates|-0.03|STANDARD_ERROR_OF_MEAN|0.12||0.826|TWO_SIDED|95.0|-0.276|0.223|||ANCOVA|||||0.223|-0.276|0.826
72474133|NCT04655027|144472607|OTHER|Baseline hs-CRP-by-treatment effect|Difference in Estimates|-0.04|STANDARD_ERROR_OF_MEAN|0.08||0.634|TWO_SIDED|95.0|-0.212|0.132|||ANCOVA|||||0.132|-0.212|0.634
72474134|NCT04655027|144472608|OTHER|Treatment effect|Ratio of Estimates|0.45|STANDARD_ERROR_OF_MEAN|1.31||0.007|TWO_SIDED|95.0|0.257|0.786|||Geometric ANCOVA|Geometric ANCOVA of relative change from baseline. The Standard error of Mean (SEM) refers to Geometric SEM.||||0.786|0.257|0.007
72507237|NCT03151148|144546498|SUPERIORITY||Geometric mean ratio (GMR)|5.47||||0.048|TWO_SIDED|95.0|1.012|29.578|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs Non-Lesional within Placebo at Day 7~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||29.578|1.012|0.048
72507238|NCT03151148|144546498|SUPERIORITY||Geometric mean ratio (GMR)|3.98||||0.13|TWO_SIDED|95.0|0.665|23.821|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs Non-Lesional within Placebo at Day 8~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||23.821|0.665|0.130
72507239|NCT03151148|144546498|SUPERIORITY||Geometric mean ratio (GMR)|13.74||||0.002|TWO_SIDED|95.0|2.542|74.304|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs Non-Lesional within Placebo at Day 11~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||74.304|2.542|0.002
72507240|NCT03151148|144546499|SUPERIORITY||Geometric mean ratio (GMR)|3.68||||0.001|TWO_SIDED|95.0|1.689|8.028|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs Non-Lesional within TMT at Day 0~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||8.028|1.689|0.001
72507241|NCT03151148|144546499|SUPERIORITY||Geometric mean ratio (GMR)|2.42||||0.027|TWO_SIDED|95.0|1.109|5.267|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs Non-Lesional within TMT at Day 4~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||5.267|1.109|0.027
72565898|NCT02691741|144662831|NON_INFERIORITY|Non-inferiority is demonstrated if the upper confidence limit of the two-sided 90% confidence interval on the treatment difference is less than 0.1 logMAR unit.|Mean Difference (Final Values)|-0.051|STANDARD_ERROR_OF_MEAN|0.0168|||TWO_SIDED|90.0|-0.078|-0.023||||||||-0.023|-0.078|
72474135|NCT04655027|144472608|OTHER|Baseline hepcidin-by-treatment effect|Difference in Estimates|-0.16|STANDARD_ERROR_OF_MEAN|0.31||0.61|TWO_SIDED|95.0|-0.798|0.48|||ANCOVA|||||0.480|-0.798|0.610
72474136|NCT04655027|144472608|OTHER|Baseline hs-CRP-by-treatment effect|Difference in Estimates|0.07|STANDARD_ERROR_OF_MEAN|0.22||0.74|TWO_SIDED|95.0|-0.387|0.536|||ANCOVA|||||0.536|-0.387|0.740
72474137|NCT05718466|144472658|SUPERIORITY|||||||0.11|||||||Log Rank|||||||0.11
72474138|NCT05718466|144472659|SUPERIORITY|||||||0.001|||||||Log Rank|||||||0.001
72474139|NCT01253135|144472690|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.1|STANDARD_DEVIATION|4.7||0.3393|TWO_SIDED|95.0|-3.08|0.84|||Prentice-Wilcoxon test||The Confidence Interval was based on a t-distribution|||0.84|-3.08|.3393
72474140|NCT01253135|144472691|SUPERIORITY_OR_OTHER|||||||0.4771|TWO_SIDED||||||Log Rank|Testing was by a Log Rank test with significance being at P \< 0.05||||||.4771
72474141|NCT00379288|144472728|SUPERIORITY_OR_OTHER_LEGACY||percentage of subjects with TEAEs|77.4||||||95.0||||||||||||
72474142|NCT00379288|144472728|SUPERIORITY_OR_OTHER_LEGACY||percentage of subjects with related AEs|28.4||||||95.0||||||||||||
72474143|NCT00379288|144472728|SUPERIORITY_OR_OTHER_LEGACY||percentage of subjects with severe AEs|5.7||||||95.0||||||||||||
72474144|NCT00379288|144472728|SUPERIORITY_OR_OTHER_LEGACY||percentage of subjects with serious AEs|4.9||||||95.0||||||||||||
72474145|NCT00379288|144472728|SUPERIORITY_OR_OTHER_LEGACY||percentage of subjects with TEAEs|79.2||||||95.0||||||||||||
72474146|NCT00379288|144472728|SUPERIORITY_OR_OTHER_LEGACY||percentage of subjects with related AEs|23.1||||||95.0||||||||||||
72474147|NCT00379288|144472728|SUPERIORITY_OR_OTHER_LEGACY||percentage of subjects with severe AEs|3.8||||||95.0||||||||||||
72474148|NCT00379288|144472728|SUPERIORITY_OR_OTHER_LEGACY||percentage of subjects with serious AEs|6.1||||||95.0||||||||||||
72474149|NCT00379288|144472728|SUPERIORITY_OR_OTHER_LEGACY||percentage of subjects with TEAEs|82.4||||||95.0||||||||||||
72474150|NCT00379288|144472728|SUPERIORITY_OR_OTHER_LEGACY||percentage of subjects with related AEs|23.5||||||95.0||||||||||||
72474151|NCT00379288|144472728|SUPERIORITY_OR_OTHER_LEGACY||percentage of subjects with severe AEs|5.9||||||95.0||||||||||||
72474152|NCT00379288|144472728|SUPERIORITY_OR_OTHER_LEGACY||percentage of subjects with serious AEs|5.8||||||95.0||||||||||||
72474153|NCT00379288|144472728|SUPERIORITY_OR_OTHER_LEGACY||percentage of subjects with TEAEs|76.9||||||95.0||||||||||||
72474154|NCT00379288|144472728|SUPERIORITY_OR_OTHER_LEGACY||percentage of subjects with related AEs|20.0||||||95.0||||||||||||
72474155|NCT00379288|144472728|SUPERIORITY_OR_OTHER_LEGACY||percentage of subjects with severe AEs|6.2||||||95.0||||||||||||
72474156|NCT00379288|144472728|SUPERIORITY_OR_OTHER_LEGACY||percentage of subjects with serious AEs|3.1||||||95.0||||||||||||
72474157|NCT00918879|144472729|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.46|STANDARD_ERROR_OF_MEAN|0.139||0.0011||95.0|-0.73|-0.18|||ANCOVA|\* adjusted for baseline HbA1c||||-0.18|-0.73|0.0011
72474158|NCT00918879|144472730|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-10.19|STANDARD_ERROR_OF_MEAN|5.438||0.0623||95.0|-20.91|0.53|||ANCOVA|\* Adjusted for baseline FPG||||0.53|-20.91|0.0623
72474159|NCT00918879|144472731|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.57|STANDARD_ERROR_OF_MEAN|0.302||0.0623||95.0|-1.17|0.02|||ANCOVA|\* Adjusted for baseline FPG||||0.02|-1.17|0.0623
72474160|NCT00918879|144472732|SUPERIORITY_OR_OTHER||Mean Difference (Net)|8.8||||||95.0|-1.7|19.3|||Fisher Exact|||||19.3|-1.7|
72474161|NCT01531673|144472739|SUPERIORITY||Least Squares (LS) Mean Difference|4.77||||0.0647|TWO_SIDED|95.0|-0.3|9.84|||Mixed-effect repeated measure (MMRM)|||||9.84|-0.3|0.0647
72474162|NCT01531673|144472739|SUPERIORITY||LS Mean Difference|-3.91||||0.1686|TWO_SIDED|95.0|-9.5|1.68|||MMRM|||||1.68|-9.5|0.1686
72474163|NCT01531673|144472739|SUPERIORITY||LS Mean Difference|-4.2||||0.0348|TWO_SIDED|95.0|-8.1|-0.31|||MMRM|||||-0.31|-8.1|0.0348
72474164|NCT01531673|144472739|SUPERIORITY||LS Mean Difference|-19.58|||<|0.0001|TWO_SIDED|95.0|-24.57|-14.59|||MMRM|||||-14.59|-24.57|<0.0001
72474165|NCT01531673|144472739|SUPERIORITY||LS Mean Difference|-5.14||||0.0101|TWO_SIDED|95.0|-9.03|-1.25|||MMRM|||||-1.25|-9.03|0.0101
72474166|NCT01531673|144472739|SUPERIORITY||LS Mean Difference|-5.19||||0.011|TWO_SIDED|95.0|-9.16|-1.21|||MMRM|||||-1.21|-9.16|0.011
72474167|NCT01531673|144472739|SUPERIORITY||LS Mean Difference|-9.6||||0.0001|TWO_SIDED|95.0|-14.38|-4.82|||MMRM|||||-4.82|-14.38|0.0001
72565899|NCT02691741|144662831|SUPERIORITY|||||||0.003|||||||Repeated Measures Analysis of Variance|||||||0.003
72474168|NCT01531673|144472739|SUPERIORITY||LS Mean Difference|-1.77||||0.3745|TWO_SIDED|95.0|-5.71|2.17|||MMRM|||||2.17|-5.71|0.3745
72474169|NCT01531673|144472740|SUPERIORITY||LS Mean Difference|-6.7||||0.0357|TWO_SIDED|95.0|-12.94|-0.46|||MMRM|||||-0.46|-12.94|0.0357
72474170|NCT01531673|144472741|SUPERIORITY||LS Mean Difference|-17.2||||0.0238|TWO_SIDED|95.0|-31.75|-2.65|||MMRM|||||-2.65|-31.75|0.0238
72474171|NCT01008553|144472756|SUPERIORITY_OR_OTHER|||||||0.0003|||||||Log Rank|||||||0.0003
72474172|NCT02187159|144472781|SUPERIORITY||Mean Difference (Final Values)|-0.61|STANDARD_ERROR_OF_MEAN|0.183||0.0008|TWO_SIDED|95.0|-0.97|-0.25|||Difference of means|||Analysis was based on multiple imputation and pattern mixture model with delta shifting.||-0.25|-0.97|0.0008
72474173|NCT02187159|144472781|SUPERIORITY||Mean Difference (Final Values)|-0.38|STANDARD_ERROR_OF_MEAN|0.183||0.0392|TWO_SIDED|95.0|-0.74|-0.02|||Difference of means|||Analysis was based on multiple imputation and pattern mixture model with delta shifting.||-0.02|-0.74|0.0392
72474174|NCT02187159|144472781|SUPERIORITY||Mean Difference (Final Values)|-0.23|STANDARD_ERROR_OF_MEAN|0.183||0.2192|TWO_SIDED|95.0|-0.58|0.13|||Difference of means|||Analysis was based on multiple imputation and pattern mixture model with delta shifting.||0.13|-0.58|0.2192
72474175|NCT02187159|144472781|SUPERIORITY||Mean Difference (Final Values)|0.23|STANDARD_ERROR_OF_MEAN|0.184||0.2095|TWO_SIDED|95.0|-0.13|0.59|||Difference of means|||Analysis was based on multiple imputation and pattern mixture model with delta shifting.||0.59|-0.13|0.2095
72474176|NCT02187159|144472781|SUPERIORITY||Mean Difference (Final Values)|0.38|STANDARD_ERROR_OF_MEAN|0.185||0.0381|TWO_SIDED|95.0|0.02|0.75|||Difference of means|||Analysis was based on multiple imputation and pattern mixture model with delta shifting.||0.75|0.02|0.0381
72474177|NCT02187159|144472783|SUPERIORITY||Mean Difference (Final Values)|-7.67|STANDARD_ERROR_OF_MEAN|1.598|<|0.0001|TWO_SIDED|95.0|-10.71|-4.44|||Difference of means|||Analysis was based on multiple imputation and pattern mixture model with delta shifting.||-4.44|-10.71|<0.0001
72474178|NCT02187159|144472783|SUPERIORITY||Mean Difference (Final Values)|-3.52|STANDARD_ERROR_OF_MEAN|1.613||0.0289|TWO_SIDED|95.0|-6.68|-0.36|||Difference of means|||Analysis was based on multiple imputation and pattern mixture model with delta shifting.||-0.36|-6.68|0.0289
72474179|NCT02187159|144472783|SUPERIORITY||Mean Difference (Final Values)|-2.56|STANDARD_ERROR_OF_MEAN|1.625||0.1148|TWO_SIDED|95.0|-5.75|0.62|||Difference of means|||Analysis was based on multiple imputation and pattern mixture model with delta shifting.||0.62|-5.75|0.1148
72474180|NCT02187159|144472783|SUPERIORITY||Mean Difference (Final Values)|4.05|STANDARD_ERROR_OF_MEAN|1.621||0.0125|TWO_SIDED|95.0|0.87|7.23|||Difference of means|||Analysis was based on multiple imputation and pattern mixture model with delta shifting.||7.23|0.87|0.0125
72474181|NCT02187159|144472783|SUPERIORITY||Mean Difference (Final Values)|5.01|STANDARD_ERROR_OF_MEAN|1.647||0.0023|TWO_SIDED|95.0|1.78|8.24|||Difference of means|||Analysis was based on multiple imputation and pattern mixture model with delta shifting.||8.24|1.78|0.0023
72474182|NCT02187159|144472785|SUPERIORITY||Difference in least squares means|-1.2|STANDARD_ERROR_OF_MEAN|0.29|<|0.0001|TWO_SIDED|95.0|-1.8|-0.7|||ANCOVA|||||-0.7|-1.8|<0.0001
72474183|NCT02187159|144472785|SUPERIORITY||Difference in least squares means|-0.6|STANDARD_ERROR_OF_MEAN|0.29||0.0247|TWO_SIDED|95.0|-1.2|-0.1|||ANCOVA|||||-0.1|-1.2|0.0247
72507242|NCT03151148|144546499|SUPERIORITY||Geometric mean ratio (GMR)|1.76||||0.153|TWO_SIDED|95.0|0.81|3.847|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs Non-Lesional within TMT at Day 7~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||3.847|0.810|0.153
72507243|NCT03151148|144546499|SUPERIORITY||Geometric mean ratio (GMR)|1.76||||0.16|TWO_SIDED|95.0|0.799|3.884|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs Non-Lesional within TMT at Day 8~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||3.884|0.799|0.160
72565900|NCT03465436|144662838|NON_INFERIORITY|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|-3.5|||||TWO_SIDED|90.0|-5.41|-1.59|||Mixed Models Analysis|||30 minutes postdose||-1.59|-5.41|
72565901|NCT03465436|144662838|NON_INFERIORITY|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|-3.54|||||TWO_SIDED|90.0|-5.18|-1.89|||Mixed Models Analysis|||1 hour postdose||-1.89|-5.18|
72565902|NCT03465436|144662838|NON_INFERIORITY|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|-4.1|||||TWO_SIDED|90.0|-5.77|-2.43|||Mixed Models Analysis|||1.5 hours postdose||-2.43|-5.77|
72623088|NCT01385995|144776486|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.6||||0.08|TWO_SIDED|95.0|-24.6|1.3|||Regression, Linear|Adjusted for period, baseline level of the outcome variable, BMI, AHI, gender and race.||Based on an intent-to-treat approach, a linear mixed effect model was used to estimate the association between therapy and measures of glucose indices, in this case 2-hour oral glucose tolerance test (OGTT) glucose, between CPAP and sham-CPAP, stratified for the most severe sleep apnea group (Apnea-Hypopnea Index (AHI) \>=30) in order to assess whether the differences in the effect of CPAP on outcomes were observed according to sleep apnea severity. N= 25.||1.3|-24.6|0.08
72474184|NCT02187159|144472785|SUPERIORITY||Difference in least squares means|-0.6|STANDARD_ERROR_OF_MEAN|0.29||0.0411|TWO_SIDED|95.0|-1.1|0.0|||ANCOVA|||||-0.0|-1.1|0.0411
72474185|NCT02187159|144472785|SUPERIORITY||Difference in least squares means|0.6|STANDARD_ERROR_OF_MEAN|0.29||0.0352|TWO_SIDED|95.0|0.0|1.2|||ANCOVA|||||1.2|0.0|0.0352
72474186|NCT02187159|144472785|SUPERIORITY||Difference in least squares means|0.7|STANDARD_ERROR_OF_MEAN|0.29||0.0214|TWO_SIDED|95.0|0.1|1.2|||ANCOVA|||||1.2|0.1|0.0214
72474187|NCT02187159|144472786|SUPERIORITY||Difference of least squares means|-0.9|STANDARD_ERROR_OF_MEAN|0.26||0.0003|TWO_SIDED|95.0|-1.5|-0.4|||ANCOVA|||Anxiety: Placebo vs Pregabalin 150 mg BID||-0.4|-1.5|0.0003
72474188|NCT02187159|144472786|SUPERIORITY||Difference of least squares means|-0.2|STANDARD_ERROR_OF_MEAN|0.26||0.5066|TWO_SIDED|95.0|-0.7|0.3|||ANCOVA|||Anxiety: Placebo vs DS-5565 15 mg QD||0.3|-0.7|0.5066
72474189|NCT02187159|144472786|SUPERIORITY||Difference of least squares means|-0.4|STANDARD_ERROR_OF_MEAN|0.26||0.1462|TWO_SIDED|95.0|-0.9|0.1|||ANCOVA|||Anxiety: Placebo vs DS-5565 15 mg BID||0.1|-0.9|0.1462
72474190|NCT02187159|144472786|SUPERIORITY||Difference of least squares means|0.8|STANDARD_ERROR_OF_MEAN|0.26||0.0035|TWO_SIDED|95.0|0.3|1.3|||ANCOVA|||Anxiety: Pregabalin 150 mg BID vs DS-5565 15 mg QD||1.3|0.3|0.0035
72565903|NCT03465436|144662838|NON_INFERIORITY|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|-3.21|||||TWO_SIDED|90.0|-5.14|-1.28|||Mixed Models Analysis|||2 hours postdose||-1.28|-5.14|
72565904|NCT03465436|144662838|NON_INFERIORITY|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|-2.46|||||TWO_SIDED|90.0|-4.41|-0.51|||Mixed Models Analysis|||2.5 hours postdose||-0.51|-4.41|
72565905|NCT03465436|144662838|NON_INFERIORITY|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|-0.91|||||TWO_SIDED|90.0|-2.84|1.03|||Mixed Models Analysis|||3 hours postdose||1.03|-2.84|
72565906|NCT03465436|144662838|NON_INFERIORITY|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|-0.62|||||TWO_SIDED|90.0|-2.53|1.29|||Mixed Models Analysis|||3.5 hours postdose||1.29|-2.53|
72623089|NCT01385995|144776487|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.4||||0.14|TWO_SIDED|95.0|-3.4|0.5|||Regression, Linear|Adjusted for period, baseline level of the outcome variable, BMI, Apnea-Hypopnea Index (AHI), gender and race.||Based on an intent-to-treat approach, a linear mixed effect model was used to estimate the association between therapy and measures of insulin indices, in this case, fasting insulin, between CPAP and sham-CPAP.||0.5|-3.4|0.14
72474191|NCT02187159|144472786|SUPERIORITY||Difference in least squares means|0.6|STANDARD_ERROR_OF_MEAN|0.26||0.0338|TWO_SIDED|95.0|0.0|1.1|||ANCOVA|||Anxiety: Pregabalin 150 mg BID vs DS-5565 15 mg BID||1.1|0.0|0.0338
72474192|NCT02187159|144472786|SUPERIORITY||Difference in least squares means|-0.7|STANDARD_ERROR_OF_MEAN|0.28||0.0116|TWO_SIDED|95.0|-1.3|-0.2|||ANCOVA|||Depression: Placebo vs Pregabalin 150 mg BID||-0.2|-1.3|0.0116
72474193|NCT02187159|144472786|SUPERIORITY||Difference of least squares means|-0.1|STANDARD_ERROR_OF_MEAN|0.28||0.7085|TWO_SIDED|95.0|-0.7|0.4|||ANCOVA|||Depression: Placebo vs DS-5565 15 mg QD||0.4|-0.7|0.7085
72474194|NCT02187159|144472786|SUPERIORITY||Difference in least squares means|0.0|STANDARD_ERROR_OF_MEAN|0.28||0.9392|TWO_SIDED|95.0|-0.5|0.6|||ANCOVA|||Depression: Placebo vs DS-5565 15 mg BID||0.6|-0.5|0.9392
72474195|NCT02187159|144472786|SUPERIORITY||Difference in least squares means|0.6|STANDARD_ERROR_OF_MEAN|0.28||0.0311|TWO_SIDED|95.0|0.1|1.2|||ANCOVA|||Depression: Pregabalin 150 mg BID vs DS-5565 15 mg QD||1.2|0.1|0.0311
72474196|NCT02187159|144472786|SUPERIORITY||Difference in least squares means|0.7|STANDARD_ERROR_OF_MEAN|0.28||0.0094|TWO_SIDED|95.0|0.2|1.3|||ANCOVA|||Depression: Pregabalin 150 mg BID vs DS-5565 15 mg BID||1.3|0.2|0.0094
72474197|NCT02187159|144472787|SUPERIORITY||Difference in least squares means|1.256|STANDARD_ERROR_OF_MEAN|0.6027||0.0373|TWO_SIDED|95.0|0.074|2.439|||ANCOVA|||Physical Component: Placebo vs Pregabalin||2.439|0.074|0.0373
72474198|NCT02187159|144472787|SUPERIORITY||Difference of least squares means|0.364|STANDARD_ERROR_OF_MEAN|0.602||0.5458|TWO_SIDED|95.0|-0.817|1.545|||ANCOVA|||Physical Component: Placebo vs DS-5565 15 mg QD||1.545|-0.817|0.5458
72474199|NCT02187159|144472787|SUPERIORITY||Difference in least squares means|0.235|STANDARD_ERROR_OF_MEAN|0.6038||0.6968|TWO_SIDED|95.0|-0.949|1.42|||ANCOVA|||Physical Component: Placebo vs DS-5565 15 mg BID||1.420|-0.949|0.6968
72474200|NCT02187159|144472787|SUPERIORITY||Difference in least squares means|-0.893|STANDARD_ERROR_OF_MEAN|0.6014||0.1379|TWO_SIDED|95.0|-2.073|0.287|||ANCOVA|||Physical Component: Pregabalin vs DS-5565 15 mg QD||0.287|-2.073|0.1379
72474201|NCT02187159|144472787|SUPERIORITY||Difference in least squares means|-1.021|STANDARD_ERROR_OF_MEAN|0.6033||0.0908|TWO_SIDED|95.0|-2.205|0.163|||ANCOVA|||Physical Component: Pregabalin vs DS-5565 15 mg BID||0.163|-2.205|0.0908
72474202|NCT02187159|144472787|SUPERIORITY||Difference in least squares means|1.89|STANDARD_ERROR_OF_MEAN|0.6965||0.0068|TWO_SIDED|95.0|0.523|3.256|||ANCOVA|||Mental Component: Placebo vs Pregabalin||3.256|0.523|0.0068
72474203|NCT02187159|144472787|SUPERIORITY||Difference in least squares means|0.406|STANDARD_ERROR_OF_MEAN|0.6956||0.5594|TWO_SIDED|95.0|-0.959|1.771|||ANCOVA|||Mental Component: Placebo vs DS-5565 15 mg QD||1.771|-0.959|0.5594
72474204|NCT02187159|144472787|SUPERIORITY||Difference in least squares means|0.023|STANDARD_ERROR_OF_MEAN|0.6979||0.9736|TWO_SIDED|95.0|-1.346|1.392|||ANCOVA|||Mental Component: Placebo vs DS-5565 15 mg BID||1.392|-1.346|0.9736
72474205|NCT02187159|144472787|SUPERIORITY||Difference in least squares means|-1.484|STANDARD_ERROR_OF_MEAN|0.6953||0.0331|TWO_SIDED|95.0|-2.848|-0.119|||ANCOVA|||Mental Component: Pregabalin vs DS-5565 15 mg QD||-0.119|-2.848|0.0331
72474206|NCT02187159|144472787|SUPERIORITY||Difference in least squares means|-1.867|STANDARD_ERROR_OF_MEAN|0.6976||0.0076|TWO_SIDED|95.0|-3.235|-0.498|||ANCOVA|||Mental Component: Pregabalin vs DS-5565 15 mg BID||-0.498|-3.235|0.0076
72474207|NCT02187159|144472788|SUPERIORITY||Difference in least squares means|0.0309|STANDARD_ERROR_OF_MEAN|0.01328||0.0201|TWO_SIDED|95.0|0.0048|0.057|||ANCOVA|||||0.0570|0.0048|0.0201
72507244|NCT03151148|144546499|SUPERIORITY||Geometric mean ratio (GMR)|1.32||||0.489|TWO_SIDED|95.0|0.603|2.868|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs Non-Lesional within TMT at Day 11~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||2.868|0.603|0.489
72507245|NCT03151148|144546499|SUPERIORITY||Geometric mean ratio (GMR)|3.1||||0.044|TWO_SIDED|95.0|1.032|9.295|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs Non-Lesional within Placebo at Day 0~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||9.295|1.032|0.044
72507246|NCT03151148|144546499|SUPERIORITY||Geometric mean ratio (GMR)|0.87||||0.805|TWO_SIDED|95.0|0.29|2.614|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs Non-Lesional within Placebo at Day 4~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||2.614|0.290|0.805
72507247|NCT03151148|144546499|SUPERIORITY||Geometric mean ratio (GMR)|3.62||||0.022|TWO_SIDED|95.0|1.205|10.859|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs Non-Lesional within Placebo at Day 7~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||10.859|1.205|0.022
72474208|NCT02187159|144472788|SUPERIORITY||Difference of least squares means|0.0178|STANDARD_ERROR_OF_MEAN|0.01324||0.1798|TWO_SIDED|95.0|-0.0082|0.0438|||ANCOVA|||||0.0438|-0.0082|0.1798
72474209|NCT02187159|144472788|SUPERIORITY||Difference of least squares means|0.0071|STANDARD_ERROR_OF_MEAN|0.01329||0.5922|TWO_SIDED|95.0|-0.0189|0.0332|||ANCOVA|||||0.0332|-0.0189|0.5922
72474210|NCT02187159|144472788|SUPERIORITY||Difference in least squares means|-0.0131|STANDARD_ERROR_OF_MEAN|0.01326||0.3221|TWO_SIDED|95.0|-0.0392|0.0129|||ANCOVA|||||0.0129|-0.0392|0.3221
72474211|NCT02187159|144472788|SUPERIORITY||Difference in least squares means|-0.0238|STANDARD_ERROR_OF_MEAN|0.0133||0.0739|TWO_SIDED|95.0|-0.0499|0.0023|||ANCOVA|||||0.0023|-0.0499|0.0739
72474212|NCT02187159|144472789|SUPERIORITY||Difference in least squares means|-0.49|STANDARD_ERROR_OF_MEAN|0.153||0.0015|TWO_SIDED|95.0|-0.79|-0.19|||Mixed Models Analysis|||||-0.19|-0.79|0.0015
72474213|NCT02187159|144472789|SUPERIORITY||Difference in least squares means|-0.56|STANDARD_ERROR_OF_MEAN|0.153||0.0003|TWO_SIDED|95.0|-0.86|-0.26|||Mixed Models Analysis|||||-0.26|-0.86|0.0003
72474214|NCT02187159|144472789|SUPERIORITY||Difference in least squares means|-0.51|STANDARD_ERROR_OF_MEAN|0.153||0.0008|TWO_SIDED|95.0|-0.81|-0.21|||Mixed Models Analysis|||||-0.21|-0.81|0.0008
72474215|NCT02187159|144472789|SUPERIORITY||Difference in least squares means|-0.07|STANDARD_ERROR_OF_MEAN|0.154||0.6464|TWO_SIDED|95.0|-0.37|0.23|||Mixed Models Analysis|||||0.23|-0.37|0.6464
72474216|NCT02187159|144472789|SUPERIORITY||Difference in least squares means|-0.03|STANDARD_ERROR_OF_MEAN|0.154||0.8543|TWO_SIDED|95.0|-0.33|0.27|||Mixed Models Analysis|||||0.27|-0.33|0.8543
72474217|NCT02187159|144472791|SUPERIORITY||Difference in least squares means|-0.6|STANDARD_ERROR_OF_MEAN|0.19||0.0014|TWO_SIDED|95.0|-1.0|0.2|||ANCOVA|||Worst pain: Placebo vs Pregabalin 150 mg BID||0.2|-1.0|0.0014
72474218|NCT02187159|144472791|SUPERIORITY||Difference of least squares means|-0.3|STANDARD_ERROR_OF_MEAN|0.19||0.1285|TWO_SIDED|95.0|-0.7|0.1|||ANCOVA|||Worst pain: Placebo vs DS-5565 15 mg QD||0.1|-0.7|0.1285
72565907|NCT03465436|144662838|NON_INFERIORITY|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|0.07|||||TWO_SIDED|90.0|-1.84|1.99|||Mixed Models Analysis|||4 hours postdose||1.99|-1.84|
72474219|NCT02187159|144472791|SUPERIORITY||Difference in least squares means|-0.1|STANDARD_ERROR_OF_MEAN|0.19||0.6595|TWO_SIDED|95.0|-0.5|0.3|||ANCOVA|||Worst pain: Placebo vs DS-5565 15 mg BID||0.3|-0.5|0.6595
72474220|NCT02187159|144472791|SUPERIORITY||Difference in least squares means|0.3|STANDARD_ERROR_OF_MEAN|0.19||0.0938|TWO_SIDED|95.0|-0.1|0.7|||ANCOVA|||Worst pain: Pregabalin 150 mg BID vs DS-5565 15 mg QD||0.7|-0.1|0.0938
72474221|NCT02187159|144472791|SUPERIORITY||Difference in least squares means|0.5|STANDARD_ERROR_OF_MEAN|0.19||0.0061|TWO_SIDED|95.0|0.1|0.9|||ANCOVA|||Worst pain: Pregabalin 150 mg BID vs DS-5565 15 mg BID||0.9|0.1|0.0061
72474222|NCT02187159|144472791|SUPERIORITY||Difference in least squares means|-0.4|STANDARD_ERROR_OF_MEAN|0.18||0.0235|TWO_SIDED|95.0|-0.8|-0.1|||ANCOVA|||Least pain: Placebo vs Pregabalin 150 mg BID||-0.1|-0.8|0.0235
72474223|NCT02187159|144472791|SUPERIORITY||Difference in least squares means|-0.2|STANDARD_ERROR_OF_MEAN|0.18||0.3652|TWO_SIDED|95.0|-0.5|0.2|||ANCOVA|||Least pain: Placebo vs DS-5565 15 mg QD||0.2|-0.5|0.3652
72474224|NCT02187159|144472791|SUPERIORITY||Difference in least squares means|-0.1|STANDARD_ERROR_OF_MEAN|0.18||0.6885|TWO_SIDED|95.0|-0.4|0.3|||ANCOVA|||Least pain: Placebo vs DS-5565 15 mg BID||0.3|-0.4|0.6885
72474225|NCT02187159|144472791|SUPERIORITY||Difference in least squares means|0.2|STANDARD_ERROR_OF_MEAN|0.18||0.1726|TWO_SIDED|95.0|-0.1|0.6|||ANCOVA|||Least pain: Pregabalin 150 mg BID vs DS-5565 15 mg QD||0.6|-0.1|0.1726
72474226|NCT02187159|144472791|SUPERIORITY||Difference in least squares means|0.3|STANDARD_ERROR_OF_MEAN|0.18||0.0627|TWO_SIDED|95.0|0.0|0.7|||ANCOVA|||Least pain: Pregabalin 150 mg BID vs DS-5565 15 mg BID||0.7|-0.0|0.0627
72474227|NCT02187159|144472791|SUPERIORITY||Difference in least squares means|-0.5|STANDARD_ERROR_OF_MEAN|0.16||0.0026|TWO_SIDED|95.0|-0.8|-0.2|||ANCOVA|||Average pain: Placebo vs Pregabalin 150 mg BID||-0.2|-0.8|0.0026
72474228|NCT02187159|144472791|SUPERIORITY||Difference in least squares means|-0.2|STANDARD_ERROR_OF_MEAN|0.16||0.1362|TWO_SIDED|95.0|-0.6|0.1|||ANCOVA|||Average pain: Placebo vs DS-5565 15 mg QD||0.1|-0.6|0.1362
72474229|NCT02187159|144472791|SUPERIORITY||Difference in least squares means|-0.1|STANDARD_ERROR_OF_MEAN|0.16||0.4344|TWO_SIDED|95.0|-0.4|0.2|||ANCOVA|||Average pain: Placebo vs DS-5565 15 mg BID||0.2|-0.4|0.4344
72474230|NCT02187159|144472791|SUPERIORITY||Difference in least squares means|0.2|STANDARD_ERROR_OF_MEAN|0.16||0.1264|TWO_SIDED|95.0|-0.1|0.6|||ANCOVA|||Average pain: Pregabalin 150 mg BID vs DS-5565 15 mg QD||0.6|-0.1|0.1264
72474231|NCT02187159|144472791|SUPERIORITY||Difference in least squares means|0.4|STANDARD_ERROR_OF_MEAN|0.16||0.026|TWO_SIDED|95.0|0.0|0.7|||ANCOVA|||Average pain: Pregabalin 150 mg BID vs DS-5565 15 mg BID||0.7|0.0|0.0260
72474232|NCT02187159|144472791|SUPERIORITY||Difference in least squares means|-0.7|STANDARD_ERROR_OF_MEAN|0.2||0.0002|TWO_SIDED|95.0|-1.1|-0.4|||ANCOVA|||Pain right now: Placebo vs Pregabalin 150 mg BID||-0.4|-1.1|0.0002
72474233|NCT02187159|144472791|SUPERIORITY||Difference in least squares means|-0.4|STANDARD_ERROR_OF_MEAN|0.2||0.0597|TWO_SIDED|95.0|-0.8|0.0|||ANCOVA|||Pain right now: Placebo vs DS-5565 15 mg QD||0.0|-0.8|0.0597
72474234|NCT02187159|144472791|SUPERIORITY||Difference in least squares means|-0.3|STANDARD_ERROR_OF_MEAN|0.2||0.1198|TWO_SIDED|95.0|-0.7|0.1|||ANCOVA|||Pain right now: Placebo vs DS-5565 15 mg BID||0.1|-0.7|0.1198
72474235|NCT02187159|144472791|SUPERIORITY||Difference in least squares means|-0.563|STANDARD_ERROR_OF_MEAN|0.1644||0.0006|TWO_SIDED|95.0|-0.885|-0.24|||ANCOVA|||Severity score: Placebo vs Pregabalin 150 mg BID||-0.240|-0.885|0.0006
72474236|NCT02187159|144472791|SUPERIORITY||Difference in least squares means|-0.261|STANDARD_ERROR_OF_MEAN|0.164||0.1118|TWO_SIDED|95.0|-0.583|0.061|||ANCOVA|||Severity score: Placebo vs DS-5565 15 mg QD||0.061|-0.583|0.1118
72474237|NCT02187159|144472791|SUPERIORITY||Difference in least squares means|-0.142|STANDARD_ERROR_OF_MEAN|0.1646||0.387|TWO_SIDED|95.0|-0.465|0.18|||ANCOVA|||Severity score: Placebo vs DS-5565 15 mg BID||0.180|-0.465|0.3870
72565908|NCT03465436|144662838|NON_INFERIORITY|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|-1.06|||||TWO_SIDED|90.0|-3.22|1.1|||Mixed Models Analysis|||6 hours postdose||1.10|-3.22|
72565909|NCT03465436|144662838|NON_INFERIORITY|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|-2.73|||||TWO_SIDED|90.0|-4.88|-0.57|||Mixed Models Analysis|||8 hours postdose||-0.57|-4.88|
72565910|NCT03465436|144662838|NON_INFERIORITY|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|-2.05|||||TWO_SIDED|90.0|-3.77|-0.32|||Mixed Models Analysis|||12 hours postdose||-0.32|-3.77|
72565911|NCT03465436|144662838|NON_INFERIORITY|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|0.21|||||TWO_SIDED|90.0|-1.9|2.33|||Mixed Models Analysis|||24 hours postdose||2.33|-1.90|
72565912|NCT03465436|144662838|NON_INFERIORITY|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|-3.83|||||TWO_SIDED|90.0|-5.56|-2.11|||Mixed Models Analysis|||30 minutes postdose||-2.11|-5.56|
72565913|NCT03465436|144662838|NON_INFERIORITY|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|-0.75|||||TWO_SIDED|90.0|-2.75|1.25|||Mixed Models Analysis|||1 hour postdose||1.25|-2.75|
72474238|NCT02187159|144472791|SUPERIORITY||Difference in least squares means|0.302|STANDARD_ERROR_OF_MEAN|0.1642||0.0633|TWO_SIDED|95.0|-0.02|0.624|||ANCOVA|||Severity score: Pregabalin 150 mg BID vs DS-5565 15 mg QD||0.624|-0.020|0.0633
72474239|NCT02187159|144472791|SUPERIORITY||Difference in least squares means|0.42|STANDARD_ERROR_OF_MEAN|0.1647||0.0108|TWO_SIDED|95.0|0.097|0.744|||ANCOVA|||Severity score: Pregabalin 150 mg BID vs DS-5565 15 mg BID||0.744|0.097|0.0108
72474240|NCT02187159|144472791|SUPERIORITY||Difference in least squares means|7.5|STANDARD_ERROR_OF_MEAN|2.41||0.002|TWO_SIDED|95.0|2.7|12.2|||ANCOVA|||Relief by treatment of pain: Placebo vs Pregabalin 150 mg BID||12.2|2.7|0.0020
72474241|NCT02187159|144472791|SUPERIORITY||Difference in least squares means|3.0|STANDARD_ERROR_OF_MEAN|2.41||0.2188|TWO_SIDED|95.0|-1.8|7.7|||ANCOVA|||Relief by treatment of pain: Placebo vs DS-5565 15 mg QD||7.7|-1.8|0.2188
72474242|NCT02187159|144472791|SUPERIORITY||Difference in least squares means|4.0|STANDARD_ERROR_OF_MEAN|2.41||0.0991|TWO_SIDED|95.0|-0.8|8.7|||ANCOVA|||Relief by treatment of pain: Placebo vs DS-5565 15 mg BID||8.7|-0.8|0.0991
72474243|NCT02187159|144472791|SUPERIORITY||Difference in least squares means|-4.5|STANDARD_ERROR_OF_MEAN|2.41||0.0611|TWO_SIDED|95.0|-9.2|0.2|||ANCOVA|||Relief by treatment of pain: Pregabalin 150 mg BID vs DS-5565 15 mg QD||0.2|-9.2|0.0611
72474244|NCT02187159|144472791|SUPERIORITY||Difference in least squares means|-3.5|STANDARD_ERROR_OF_MEAN|2.41||0.1489|TWO_SIDED|95.0|-8.2|1.2|||ANCOVA|||Relief by treatment of pain: Pregabalin 150 mg BID vs DS-5565 15 mg BID||1.2|-8.2|0.1489
72474245|NCT02187159|144472791|SUPERIORITY||Difference in least squares means|-6.04|STANDARD_ERROR_OF_MEAN|1.751||0.0006|TWO_SIDED|95.0|-9.47|-2.6|||ANCOVA|||Interference: Placebo vs Pregabalin 150 mg BID||-2.60|-9.47|0.0006
72474246|NCT02187159|144472791|SUPERIORITY||Difference in least squares means|-4.09|STANDARD_ERROR_OF_MEAN|1.747||0.0193|TWO_SIDED|95.0|-7.52|-0.67|||ANCOVA|||Interference: Placebo vs DS-5565 15 mg QD||-0.67|-7.52|0.0193
72474247|NCT02187159|144472791|SUPERIORITY||Difference in least squares means|-1.64|STANDARD_ERROR_OF_MEAN|1.752||0.3506|TWO_SIDED|95.0|-5.07|1.8|||ANCOVA|||Interference: Placebo vs DS-5565 15 mg BID||1.80|-5.07|0.3506
72474248|NCT02187159|144472791|SUPERIORITY||Difference in least squares means|1.94|STANDARD_ERROR_OF_MEAN|1.748||0.266|TWO_SIDED|95.0|-1.48|5.37|||ANCOVA|||Interference: Pregabalin 150 mg BID vs DS-5565 15 mg QD||5.37|-1.48|0.2660
72474249|NCT02187159|144472791|SUPERIORITY||Difference in least squares means|4.4|STANDARD_ERROR_OF_MEAN|1.754||0.0122|TWO_SIDED|95.0|0.96|7.84|||ANCOVA|||Interference: Pregabalin 150 mg BID vs DS-5565 15 mg BID||7.84|0.96|0.0122
72474250|NCT02187159|144472791|SUPERIORITY||Difference in least squares means|-0.5|STANDARD_ERROR_OF_MEAN|0.2||0.0119|TWO_SIDED|95.0|-0.9|-0.1|||ANCOVA|||General activity: Placebo vs Pregabalin 150 mg BID||-0.1|-0.9|0.0119
72474251|NCT02187159|144472791|SUPERIORITY||Difference in least squares means|-0.4|STANDARD_ERROR_OF_MEAN|0.2||0.0659|TWO_SIDED|95.0|-0.8|0.0|||ANCOVA|||General activity: Placebo vs DS-5565 15 mg QD||0.0|-0.8|0.0659
72507248|NCT03151148|144546499|SUPERIORITY||Geometric mean ratio (GMR)|4.83||||0.01|TWO_SIDED|95.0|1.458|15.978|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs Non-Lesional within Placebo at Day 8~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||15.978|1.458|0.010
72507249|NCT03151148|144546499|SUPERIORITY||Geometric mean ratio (GMR)|2.19||||0.169|TWO_SIDED|95.0|0.716|6.692|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs Non-Lesional within Placebo at Day 11~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||6.692|0.716|0.169
72474252|NCT02187159|144472791|SUPERIORITY||Difference in least squares means|-0.1|STANDARD_ERROR_OF_MEAN|0.2||0.5104|TWO_SIDED|95.0|-0.5|0.3|||ANCOVA|||General activity: Placebo vs DS-5565 15 mg BID||0.3|-0.5|0.5104
72474253|NCT02187159|144472791|SUPERIORITY||Difference in least squares means|0.1|STANDARD_ERROR_OF_MEAN|0.2||0.4934|TWO_SIDED|95.0|-0.3|0.5|||ANCOVA|||General activity: Pregabalin 150 mg BID vs DS-5565 15 mg QD||0.5|-0.3|0.4934
72474254|NCT02187159|144472791|SUPERIORITY||Difference in least squares means|0.4|STANDARD_ERROR_OF_MEAN|0.2||0.0634|TWO_SIDED|95.0|0.0|0.8|||ANCOVA|||General activity: Pregabalin 150 mg BID vs DS-5565 15 mg BID||0.8|-0.0|0.0634
72474255|NCT02187159|144472791|SUPERIORITY||Difference in least squares means|-0.7|STANDARD_ERROR_OF_MEAN|0.21||0.0007|TWO_SIDED|95.0|-1.1|-0.3|||ANCOVA|||Mood: Placebo vs Pregabalin 150 mg BID||-0.3|-1.1|0.0007
72474256|NCT02187159|144472791|SUPERIORITY||Difference in least squares means|-0.4|STANDARD_ERROR_OF_MEAN|0.21||0.0837|TWO_SIDED|95.0|-0.8|0.0|||ANCOVA|||Mood: Placebo vs DS-5565 15 mg QD||0.0|-0.8|0.0837
72474257|NCT02187159|144472791|SUPERIORITY||Difference in least squares means|-0.2|STANDARD_ERROR_OF_MEAN|0.21||0.2379|TWO_SIDED|95.0|-0.7|0.2|||ANCOVA|||Mood: Placebo vs DS-5565 15 mg BID||0.2|-0.7|0.2379
72474258|NCT02187159|144472791|SUPERIORITY||Difference in least squares means|0.3|STANDARD_ERROR_OF_MEAN|0.21||0.098|TWO_SIDED|95.0|-0.1|0.8|||ANCOVA|||Mood: Pregabalin 150 mg BID vs DS-5565 15 mg QD||0.8|-0.1|0.0980
72474259|NCT02187159|144472791|SUPERIORITY||Difference in least squares means|0.5|STANDARD_ERROR_OF_MEAN|0.21||0.0283|TWO_SIDED|95.0|0.0|0.9|||ANCOVA|||Mood: Pregabalin 150 mg BID vs DS-5565 15 mg BID||0.9|0.0|0.0283
72474260|NCT02187159|144472791|SUPERIORITY||Difference in least squares means|-0.3|STANDARD_ERROR_OF_MEAN|0.21||0.2179|TWO_SIDED|95.0|-0.7|0.2|||ANCOVA|||Walking ability: Placebo vs Pregabalin 150 mg BID||0.2|-0.7|0.2179
72474261|NCT02187159|144472791|SUPERIORITY||Difference in least squares means|-0.1|STANDARD_ERROR_OF_MEAN|0.21||0.6683|TWO_SIDED|95.0|-0.5|0.3|||ANCOVA|||Walking ability: Placebo vs DS-5565 15 mg QD||0.3|-0.5|0.6683
72474262|NCT02187159|144472791|SUPERIORITY||Difference in least squares means|0.3|STANDARD_ERROR_OF_MEAN|0.21||0.2247|TWO_SIDED|95.0|-0.2|0.7|||ANCOVA|||Walking ability: Placebo vs DS-5565 15 mg BID||0.7|-0.2|0.2247
72474263|NCT02187159|144472791|SUPERIORITY||Difference in least squares means|0.2|STANDARD_ERROR_OF_MEAN|0.21||0.4198|TWO_SIDED|95.0|-0.2|0.6|||ANCOVA|||Walking ability: Pregabalin 150 mg BID vs DS-5565 15 mg QD||0.6|-0.2|0.4198
72474264|NCT02187159|144472791|SUPERIORITY||Difference in least squares means|0.5|STANDARD_ERROR_OF_MEAN|0.21||0.0146|TWO_SIDED|95.0|0.1|0.9|||ANCOVA|||Walking ability: Pregabalin 150 mg BID vs DS-5565 15 mg BID||0.9|0.1|0.0146
72474265|NCT02187159|144472791|SUPERIORITY||Difference in least squares means|-0.4|STANDARD_ERROR_OF_MEAN|0.21||0.0662|TWO_SIDED|95.0|-0.8|0.0|||ANCOVA|||Normal work: Placebo vs Pregabalin 150 mg BID||0.0|-0.8|0.0662
72474266|NCT02187159|144472791|SUPERIORITY||Difference in least squares means|-0.3|STANDARD_ERROR_OF_MEAN|0.21||0.2282|TWO_SIDED|95.0|-0.7|0.2|||ANCOVA|||Normal work: Placebo vs DS-5565 15 mg QD||0.2|-0.7|0.2282
72474267|NCT02187159|144472791|SUPERIORITY||Difference in least squares means|-0.1|STANDARD_ERROR_OF_MEAN|0.21||0.7336|TWO_SIDED|95.0|-0.5|0.3|||ANCOVA|||Normal work: Placebo vs DS-5565 15 mg BID||0.3|-0.5|0.7336
72474268|NCT02187159|144472791|SUPERIORITY||Difference in least squares means|0.1|STANDARD_ERROR_OF_MEAN|0.21||0.524|TWO_SIDED|95.0|-0.3|0.5|||ANCOVA|||Normal work: Pregabalin 150 mg BID vs DS-5565 15 mg QD||0.5|-0.3|0.5240
72565914|NCT03465436|144662838|NON_INFERIORITY|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|0.45|||||TWO_SIDED|90.0|-1.49|2.38|||Mixed Models Analysis|||1.5 hours postdose||2.38|-1.49|
72565915|NCT03465436|144662838|NON_INFERIORITY|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|2.58|||||TWO_SIDED|90.0|0.58|4.58|||Mixed Models Analysis|||2 hours postdose||4.58|0.58|
72474269|NCT02187159|144472791|SUPERIORITY||Difference in least squares means|0.3|STANDARD_ERROR_OF_MEAN|0.21||0.1349|TWO_SIDED|95.0|-0.1|0.7|||ANCOVA|||Normal work: Pregabalin 150 mg BID vs DS-5565 15 mg BID||0.7|-0.1|0.1349
72474270|NCT02187159|144472791|SUPERIORITY||Difference in least squares means|-0.4|STANDARD_ERROR_OF_MEAN|0.21||0.0464|TWO_SIDED|95.0|-0.8|0.0|||ANCOVA|||Relations with other people: Placebo vs Pregabalin 150 mg BID||-0.0|-0.8|0.0464
72474271|NCT02187159|144472791|SUPERIORITY||Difference in least squares means|-0.3|STANDARD_ERROR_OF_MEAN|0.21||0.0975|TWO_SIDED|95.0|-0.7|0.1|||ANCOVA|||Relations with other people: Placebo vs DS-5565 15 mg QD||0.1|-0.7|0.0975
72474272|NCT02187159|144472791|SUPERIORITY||Difference in least squares means|0.1|STANDARD_ERROR_OF_MEAN|0.21||0.6088|TWO_SIDED|95.0|-0.3|0.5|||ANCOVA|||Relations with other people: Placebo vs DS-5565 15 mg BID||0.5|-0.3|0.6088
72474273|NCT02187159|144472791|SUPERIORITY||Difference in least squares means|0.1|STANDARD_ERROR_OF_MEAN|0.21||0.7341|TWO_SIDED|95.0|-0.3|0.5|||ANCOVA|||Relations with other people: Pregabalin 150 mg BID vs DS-5565 15 mg QD||0.5|-0.3|0.7341
72474274|NCT02187159|144472791|SUPERIORITY||Difference in least squares means|0.5|STANDARD_ERROR_OF_MEAN|0.21||0.0125|TWO_SIDED|95.0|0.1|0.9|||ANCOVA|||Relations with other people: Pregabalin 150 mg BID vs DS-5565 15 mg BID||0.9|0.1|0.0125
72474275|NCT02187159|144472791|SUPERIORITY||Difference in least squares means|-1.0|STANDARD_ERROR_OF_MEAN|0.23|<|0.0001|TWO_SIDED|95.0|-1.4|-0.5|||ANCOVA|||Sleep: Placebo vs Pregabalin 150 mg BID||-0.5|-1.4|<0.0001
72474276|NCT02187159|144472791|SUPERIORITY||Difference in least squares means|-0.8|STANDARD_ERROR_OF_MEAN|0.23||0.0003|TWO_SIDED|95.0|-1.3|-0.4|||ANCOVA|||Sleep: Placebo vs DS-5565 15 mg QD||-0.4|-1.3|0.0003
72474277|NCT02187159|144472791|SUPERIORITY||Difference in least squares means|-0.7|STANDARD_ERROR_OF_MEAN|0.23||0.004|TWO_SIDED|95.0|-1.1|-0.2|||ANCOVA|||Sleep: Placebo vs DS-5565 15 mg BID||-0.2|-1.1|0.0040
72474278|NCT02187159|144472791|SUPERIORITY||Difference in least squares means|0.1|STANDARD_ERROR_OF_MEAN|0.23||0.5801|TWO_SIDED|95.0|-0.3|0.6|||ANCOVA|||Sleep: Pregabalin 150 mg BID vs DS-5565 15 mg QD||0.6|-0.3|0.5801
72474279|NCT02187159|144472791|SUPERIORITY||Difference in least squares means|0.3|STANDARD_ERROR_OF_MEAN|0.23||0.1869|TWO_SIDED|95.0|-0.1|0.7|||ANCOVA|||Sleep: Pregabalin 150 mg BID vs DS-5565 15 mg BID||0.7|-0.1|0.1869
72474280|NCT02187159|144472791|SUPERIORITY||Difference in least squares means|-0.8|STANDARD_ERROR_OF_MEAN|0.22||0.0002|TWO_SIDED|95.0|-1.3|-0.4|||ANCOVA|||Enjoyment of life: Placebo vs Pregabalin 150 mg BID||-0.4|-1.3|0.0002
72474281|NCT02187159|144472791|SUPERIORITY||Difference in least squares means|-0.5|STANDARD_ERROR_OF_MEAN|0.22||0.0271|TWO_SIDED|95.0|-0.9|-0.1|||ANCOVA|||Enjoyment of life: Placebo vs DS-5565 15 mg QD||-0.1|-0.9|0.0271
72474282|NCT02187159|144472791|SUPERIORITY||Difference in least squares means|-0.4|STANDARD_ERROR_OF_MEAN|0.22||0.1123|TWO_SIDED|95.0|-0.8|0.1|||ANCOVA|||Enjoyment of life: Placebo vs DS-5565 15 mg BID||0.1|-0.8|0.1123
72474283|NCT02187159|144472791|SUPERIORITY||Difference in least squares means|0.3|STANDARD_ERROR_OF_MEAN|0.22||0.1183|TWO_SIDED|95.0|-0.1|0.8|||ANCOVA|||Enjoyment of life: Pregabalin 150 mg BID vs DS-5565 15 mg QD||0.8|-0.1|0.1183
72565916|NCT03465436|144662838|NON_INFERIORITY|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|2.85|||||TWO_SIDED|90.0|0.73|4.98|||Mixed Models Analysis|||2.5 hours postdose||4.98|0.73|
72565917|NCT03465436|144662838|NON_INFERIORITY|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|3.94|||||TWO_SIDED|90.0|1.85|6.03|||Mixed Models Analysis|||3 hours postdose||6.03|1.85|
72565918|NCT03465436|144662838|NON_INFERIORITY|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|5.28|||||TWO_SIDED|90.0|3.61|6.95|||Mixed Models Analysis|||3.5 hours postdose||6.95|3.61|
72565919|NCT03465436|144662838|NON_INFERIORITY|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|6.94|||||TWO_SIDED|90.0|4.99|8.89|||Mixed Models Analysis|||4 hours postdose||8.89|4.99|
72565920|NCT03465436|144662838|NON_INFERIORITY|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|3.13|||||TWO_SIDED|90.0|0.93|5.34|||Mixed Models Analysis|||6 hours postdose||5.34|0.93|
72474284|NCT02187159|144472791|SUPERIORITY||Difference in least squares means|0.5|STANDARD_ERROR_OF_MEAN|0.22||0.0299|TWO_SIDED|95.0|0.0|0.9|||ANCOVA|||Enjoyment of life: Pregabalin 150 mg BID vs DS-5565 15 mg BID||0.9|0.0|0.0299
72474285|NCT02187159|144472792|SUPERIORITY||Difference in least squares means|-0.015|STANDARD_ERROR_OF_MEAN|0.0249||0.5578|TWO_SIDED|95.0|-0.063|0.034|||ANCOVA|||||0.034|-0.063|0.5578
72474286|NCT02187159|144472792|SUPERIORITY||Difference in least squares means|-0.009|STANDARD_ERROR_OF_MEAN|0.0248||0.7034|TWO_SIDED|95.0|-0.058|0.039|||ANCOVA|||||0.039|-0.058|0.7034
72474287|NCT02187159|144472792|SUPERIORITY||Difference in least squares means|-0.02|STANDARD_ERROR_OF_MEAN|0.0249||0.4143|TWO_SIDED|95.0|-0.069|0.028|||ANCOVA|||||0.028|-0.069|0.4143
72474288|NCT02187159|144472792|SUPERIORITY||Difference in least squares means|0.005|STANDARD_ERROR_OF_MEAN|0.0249||0.8365|TWO_SIDED|95.0|-0.044|0.054|||ANCOVA|||||0.054|-0.044|0.8365
72474289|NCT02187159|144472792|SUPERIORITY||Difference in least squares means|-0.006|STANDARD_ERROR_OF_MEAN|0.0249||0.8189|TWO_SIDED|95.0|-0.055|0.043|||ANCOVA|||||0.043|-0.055|0.8189
72474290|NCT00567567|144472793|SUPERIORITY_OR_OTHER_LEGACY||Log Rank Test Statistic|6.9883||||0.0082|TWO_SIDED|95.0|||||Log Rank|||The event-free survival distributions of patients randomized to Regimen A - Single HST (CEM) and randomized to Regimen B - Tandem HST (CEM) were compared using the log-rank test.||||0.0082
72565921|NCT03465436|144662838|NON_INFERIORITY|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|2.09|||||TWO_SIDED|90.0|-0.23|4.4|||Mixed Models Analysis|||8 hours postdose||4.40|-0.23|
72565922|NCT03465436|144662838|NON_INFERIORITY|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|1.37|||||TWO_SIDED|90.0|-0.57|3.3|||Mixed Models Analysis|||12 hours postdose||3.30|-0.57|
72565923|NCT03465436|144662838|NON_INFERIORITY|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|-0.29|||||TWO_SIDED|90.0|-2.21|1.63|||Mixed Models Analysis|||24 hours postdose||1.63|-2.21|
72623090|NCT01385995|144776487|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.7||||0.12|TWO_SIDED|95.0|-23.3|2.8|||Regression, Linear|Adjusted for period, baseline level of the outcome variable, BMI, Apnea-Hypopnea Index (AHI), gender and race.||Based on an intent-to-treat approach, a linear mixed effect model was used to estimate the association between therapy and measures of insulin indices, in this case, 2-hour oral glucose tolerance test (OGTT) insulin, between CPAP and sham-CPAP.||2.8|-23.3|0.12
72474291|NCT00567567|144472794|SUPERIORITY_OR_OTHER_LEGACY||Chi-squared test statistic|8.5751||||0.0034|TWO_SIDED|95.0|||||Chi-squared|||Chi-square test of proportions in all patients to compare the proportion of responders (complete response \[CR\]+ very good partial response \[VGPR\]) at the end of induction therapy in this study to an analogous cohort of responders in A3973.||||0.0034
72474292|NCT00567567|144472795|SUPERIORITY_OR_OTHER_LEGACY||Gray's test statistic|0.33709||||0.5615|TWO_SIDED|95.0|||||Gray's test for competing risks|||The cumulative incidence rates of local recurrence between patients from ANBL0532 randomized or assigned to receive single CEM transplant and boost radiation and A3973 patients who were transplanted and received boost radiation were compared using Gray's test.||||0.5615
72474293|NCT00567567|144472796|SUPERIORITY_OR_OTHER_LEGACY||Slope|-0.0557||||0.0939|TWO_SIDED|95.0|||||Regression, Logistic|||||||0.0939
72474294|NCT00567567|144472797|SUPERIORITY_OR_OTHER_LEGACY||Slope|0.0543||||0.3277|TWO_SIDED|95.0|||||Regression, Logistic|||||||0.3277
72474295|NCT00567567|144472798|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.4328||||0.7598|TWO_SIDED|95.0|0.4105|5.001|||Fisher Exact|Fisher's exact test was used instead of chi-square test due to small expected cell counts.||Null Hypothesis: The response rate after two cycles of induction therapy and the presence of a polymorphism are independent in the study population||5.001|0.4105|0.7598
72474296|NCT00567567|144472802|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.015||||0.6853|TWO_SIDED|95.0|||||Regression, Cox|||The relationship between the peak serum isotretinoin concentration level with event-free survival was explored with a Cox proportional hazards model. Eligible patients treated with isotretinoin on A3973, ANBL0032, ANBL0532, or ANBL0931 with peak serum concentration level data were included in the analysis.||||0.6853
72474297|NCT00403767|144472844|NON_INFERIORITY_OR_EQUIVALENCE|Alternative hypothesis of non-inferiority (NI) by a NI margin of 1.46 in hazard ratio (HR) based on on-treatment data from the per protocol population. The required number of primary efficacy endpoint events was determined based on the following assumptions: NI margin of 1.46, 1-sided alpha of 0.025, power of \>95% when true HR is 1, and exponential distributions. The margin was selected based on clinical appropriateness and quantitative analysis of relevant studies in Hart et al.|Hazard Ratio (HR)|0.79|||<|0.001|TWO_SIDED|95.0|0.66|0.96||The p-value is not adjusted for multiple comparisons. The alpha threshold for statistical significance is 0.025 (1-sided).|Cox Proportional Hazards model|(non-stratified) Cox Proportional Hazards model with treatment as covariate||||0.96|0.66|<0.001
72474298|NCT00403767|144472845|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.79||||0.015|TWO_SIDED|95.0|0.65|0.95||The p-value Is not adjusted for multiple comparisons. The alpha threshold for statistical significance is 0.05 (2-sided).|Cox Proportional Hazards model|(non-stratified) Cox Proportional Hazards model with treatment as covariate||Alternative hypothesis of superiority based on on-treatment data from the safety population.||0.95|0.65|0.015
72474299|NCT00403767|144472846|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.03||||0.442|TWO_SIDED|95.0|0.96|1.11||The p-value is not adjusted for mulitple comparisons. The alpha threshold for statistical significance is 0.05 (2-sided).|Cox Proportional Hazards model|(non-stratified) Cox Proportional Hazards model with treatment as a covariate||Alternate hypothesis of superiority based on on-treatment data from the safety population.||1.11|0.96|0.442
72474300|NCT00403767|144472847|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.86||||0.034|TWO_SIDED|95.0|0.74|0.99||The p-value is not adjusted for multiple comparisons. The alpha threshold for statistical significance is 0.05 (2-sided).|Cox Proportional Hazards model|(non-stratified) Cox Proportional Hazards model with treatment as covariate||Alternative hypothesis of superiority based on on-treatment data from the safety population.||0.99|0.74|0.034
72474301|NCT00403767|144472848|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.85||||0.01|TWO_SIDED|95.0|0.74|0.96||The p-value is not adjusted for multiple comparisons. The alpha threshold for statistical significance is 0.05 (2-sided).|Cox Proportional Hazards model|(non-stratified) Cox Proportional Hazards model with treatment as covariate||Alternative hypothesis of superiority based on on-treatment data from the safety population.||0.96|0.74|0.010
72474302|NCT00403767|144472849|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.85||||0.092|TWO_SIDED|95.0|0.7|1.03||The p-value is not adjusted for multiple comparisons. The alpha threshold for statistical significance is 0.05 (2-sided).|Cox Proportional Hazards model|(non-stratified) Cox Proportional Hazards model with treatment as a covariate||Alternative hypothesis of superiority based on on-treatment data from the safety population.||1.03|0.70|0.092
72565924|NCT03465436|144662838|SUPERIORITY||LS Mean|7.32|||||TWO_SIDED|90.0|5.03|9.6|||Mixed Models Analysis|||30 minutes postdose||9.60|5.03|
72565925|NCT03465436|144662838|SUPERIORITY||LS Mean|12.28|||||TWO_SIDED|90.0|10.47|14.1|||Mixed Models Analysis|||1 hour postdose||14.10|10.47|
72565926|NCT03465436|144662838|SUPERIORITY||LS Mean|11.27|||||TWO_SIDED|90.0|9.54|13.0|||Mixed Models Analysis|||1.5 hours postdose||13.00|9.54|
72565927|NCT03465436|144662838|SUPERIORITY||LS Mean|11.92|||||TWO_SIDED|90.0|9.97|13.87|||Mixed Models Analysis|||2 hours postdose||13.87|9.97|
72565928|NCT03465436|144662838|SUPERIORITY||LS Mean|10.98|||||TWO_SIDED|90.0|9.17|12.79|||Mixed Models Analysis|||2.5 hours postdose||12.79|9.17|
72565929|NCT03465436|144662838|SUPERIORITY||LS Mean|11.99|||||TWO_SIDED|90.0|10.1|13.87|||Mixed Models Analysis|||3 hours postdose||13.87|10.10|
72565930|NCT03465436|144662838|SUPERIORITY||LS Mean|12.19|||||TWO_SIDED|90.0|10.32|14.05|||Mixed Models Analysis|||3.5 hours postdose||14.05|10.32|
72565931|NCT03465436|144662838|SUPERIORITY||LS Mean|11.68|||||TWO_SIDED|90.0|9.83|13.52|||Mixed Models Analysis|||4 hours postdose||13.52|9.83|
72474303|NCT00403767|144472850|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.23||||0.003|TWO_SIDED|95.0|0.09|0.61||The p-value is not adjusted for multiple comparisons. The alpha threshold for statistical significance is 0.05 (2-sided).|Cox Proportional Hazards model|(non-stratified) Cox Proportional Hazards model with treatment as covariate||Alternative hypothesis of superiority based on on-treatment data from the safety population.||0.61|0.09|0.003
72474304|NCT00403767|144472851|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.81||||0.121|TWO_SIDED|95.0|0.63|1.06||The p-value is not adjusted for multiple comparisons. The alpha threshold for statistical significance is 0.05 (2-sided).|Cox Proportional Hazards model|(non-stratified) Cox Proportional Hazards model with treatment as a covariate||Alternative hypothesis of superiority based on on-treatment data from the safety population.||1.06|0.63|0.121
72474305|NCT00403767|144472852|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.89||||0.289|TWO_SIDED|95.0|0.73|1.1||The p-value is not adjusted for multiple comparisons. The alpha threshold for statistical significance is 0.05 (2-sided).|Cox Proportional Hazards model|(non-stratified) Cox Proportional Hazards model with treatment as a covariate||Alternative hypothesis of superiority based on on-treatment data from the safety population.||1.10|0.73|0.289
72474306|NCT00403767|144472853|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.85||||0.073|TWO_SIDED|95.0|0.7|1.02||The p-value is not adjusted for multiple comparisons. The alpha threshold for statistical significance is 0.05 (2-sided).|Cox Proportional Hazards model|(non-stratified) Cox Proportional Hazards model with treatment as covariate||Alternative hypothesis of superiority based on on-treatment data from the safety population.||1.02|0.70|0.073
72474307|NCT03192475|144472854|SUPERIORITY|||||||0.01|||||||Mixed Models Analysis|||||||0.01
72474308|NCT03192475|144472855|SUPERIORITY|||||||0.15|||||||Mixed Models Analysis|||||||0.15
72474309|NCT03192475|144472856|SUPERIORITY|||||||0.25|||||||Mixed Models Analysis|||||||0.25
72474310|NCT03192475|144472857|SUPERIORITY|||||||0.11|||||||Mixed Models Analysis|||||||0.11
72474311|NCT03192475|144472858|SUPERIORITY|||||||0.09|||||||Mixed Models Analysis|||||||0.09
72474312|NCT03192475|144472859|SUPERIORITY|||||||0.53|||||||Mixed Models Analysis|||||||0.53
72474313|NCT03192475|144472860|SUPERIORITY|||||||0.21|||||||Mixed Models Analysis|||||||0.21
72507250|NCT03151148|144546500|SUPERIORITY||Geometric mean ratio (GMR)|0.176||||0.035|TWO_SIDED|95.0|0.0351|0.8807|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Change from baseline is based on the difference in log10 post-baseline and log10 baseline values. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs. Non-lesional within TMT at Day 0~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||0.8807|0.0351|0.035
72565932|NCT03465436|144662838|SUPERIORITY||LS Mean|8.24|||||TWO_SIDED|90.0|6.1|10.39|||Mixed Models Analysis|||6 hours postdose||10.39|6.10|
72565933|NCT03465436|144662838|SUPERIORITY||LS Mean|7.87|||||TWO_SIDED|90.0|5.66|10.07|||Mixed Models Analysis|||8 hours postdose||10.07|5.66|
72565934|NCT03465436|144662838|SUPERIORITY||LS Mean|6.35|||||TWO_SIDED|90.0|4.32|8.38|||Mixed Models Analysis|||12 hours postdose||8.38|4.32|
72565935|NCT03465436|144662838|SUPERIORITY||LS Mean|6.13|||||TWO_SIDED|90.0|3.88|8.38|||Mixed Models Analysis|||24 hours postdose||8.38|3.88|
72474314|NCT03192475|144472861|SUPERIORITY|||||||0.6|||||||Mixed Models Analysis|||||||0.60
72474315|NCT03192475|144472862|SUPERIORITY|||||||0.15|||||||Mixed Models Analysis|||||||0.15
72474316|NCT03192475|144472863|SUPERIORITY|||||||0.96|||||||Mixed Models Analysis|||||||0.96
72474317|NCT03192475|144472864|SUPERIORITY|||||||0.96|||||||Mixed Models Analysis|||||||0.96
72474318|NCT03192475|144472865|SUPERIORITY|||||||0.0009|||||||Mantel Haenszel|||||||0.0009
72474319|NCT03192475|144472866|SUPERIORITY|||||||0.18|||||||Mixed Models Analysis|||||||0.18
72474320|NCT03192475|144472867|SUPERIORITY|||||||0.34|||||||Mixed Models Analysis|||||||0.34
72474321|NCT03192475|144472868|SUPERIORITY|||||||0.82|||||||Mixed Models Analysis|||||||0.82
72474322|NCT05319912|144472877|OTHER||Geometric Mean Ratio (%)|75.81|||||TWO_SIDED|90.0|52.23|110.02||||||Analysis was performed using analysis of variance (ANOVA).||110.02|52.23|
72474323|NCT05319912|144472877|OTHER||Geometric Mean Ratio (%)|25.2|||||TWO_SIDED|90.0|17.21|36.89||||||Analysis was performed using ANOVA.||36.89|17.21|
72474324|NCT05319912|144472878|OTHER||Geometric Mean Ratio (%)|82.65|||||TWO_SIDED|90.0|63.91|106.9||||||Analysis was performed using ANOVA.||106.90|63.91|
72474325|NCT05319912|144472878|OTHER||Geometric Mean Ratio (%)|40.49|||||TWO_SIDED|90.0|31.12|52.68||||||Analysis was performed using ANOVA.||52.68|31.12|
72474326|NCT01204710|144472894|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.29||||0.2201|TWO_SIDED|95.0|0.87|1.9||Analysis was stratified by the randomization stratification factor: best overall response to prior docetaxel-based chemotherapy.|Log Rank||Hazard ratio is expressed as IMC-3G3 + Mitoxantrone / Mitoxantrone and estimated from Cox model.|||1.90|0.87|0.2201
72474327|NCT01204710|144472895|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.08||||0.7291|TWO_SIDED|95.0|0.72|1.61||Analysis was stratified by the randomization stratification factor: best overall response to prior docetaxel-based chemotherapy.|Log Rank||Hazard ratio is expressed as Olaratumab + Mitoxantrone / Mitoxantrone and estimated from Cox model.|||1.61|0.72|0.7291
72474328|NCT01204710|144472896|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3465|TWO_SIDED||||||Fisher Exact|||||||0.3465
72474329|NCT01204710|144472897|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6571|TWO_SIDED||||||Fisher Exact|||||||0.6571
72565936|NCT03465436|144662839|NON_INFERIORITY|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|-4.49|||||TWO_SIDED|90.0|-6.47|-2.52|||Mixed Models Analysis|||30 minutes postdose||-2.52|-6.47|
72565937|NCT03465436|144662839|NON_INFERIORITY|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|-5.3|||||TWO_SIDED|90.0|-7.18|-3.42|||Mixed Models Analysis|||1 hour postdose||-3.42|-7.18|
72474330|NCT01204710|144472898|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4986|TWO_SIDED||||||Fisher Exact|||||||0.4986
72474331|NCT01276379|144472906|SUPERIORITY||Hazard Ratio (HR)|2.01||||0.004|TWO_SIDED|95.0|1.23|3.29|||Log Rank|||||3.29|1.23|0.004
72474332|NCT01276379|144472907|SUPERIORITY||Hazard Ratio (HR)|2.29|||<|0.0001|TWO_SIDED|95.0|1.33|3.96|||Log Rank|||||3.96|1.33|<0.0001
72398330|NCT04483011|144303021|SUPERIORITY||Mean Difference (Net)|4.01|STANDARD_DEVIATION|6.57||0.014|TWO_SIDED|||||p \< 0.05|ANCOVA||The p value between RiaGev and Comparator groups at Day 5 over Day 1 is reported.|A comparison between RiaGev and Comparator supplementation.||||0.014
72474333|NCT00864253|144472912|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.792||||0.044|TWO_SIDED|95.1|0.631|0.992||An interim safety review was performed by DMC. An alpha spending function was utilized to preserve the overall Type 1 error at 0.050. The spending function allocated alpha of 0.001 and 0.049 to the interim and final analyses of PFS, respectively.|Log Rank|The treatment difference was tested using the stratified log-rank test, stratified by metastatic stage, region, and baseline LDH.||Two hundred fifty-seven (257) patients were to be randomized to each treatment group for a total of 514 patients. This sample size was chosen to provide at least 80% power for the final analysis (with a two-sided type I error of 0.049) to reject the null hypothesis that the ABI 007/dacarbazine hazard ratio (HR) for PFS is equal to 1.0. This sample size calculation was based on estimates of HR = 0.750. Proportional hazards were assumed.||0.992|0.631|0.044
72474334|NCT00864253|144472913|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.831||||0.094|TWO_SIDED|99.9|0.578|1.196||At the time of the final PFS analysis, an interim analysis of survival was reported. The spending function allocated an alpha of 0.001 and 0.049 for the interim and final analysis, respectively, to preserve the overall Type I error at 0.050.|Log Rank|The treatment difference was tested using the stratified log-rank test, stratified by metastatic stage, region, and baseline LDH.||For the participant survival, at the time at least 417 events are recorded, this sample size provides at least 80% power with a two-sided Type 1 error of 0.049 to reject the null hypothesis that the ABI-007/dacarbazine hazard ratio is equal to 1.0. This was based on a HR = 0.760. Proportional hazards were assumed.||1.196|0.578|0.094
72474335|NCT00864253|144472914|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.845||||0.086|TWO_SIDED|95.0|0.696|1.025|||Log Rank|The treatment difference was tested using the stratified log-rank test, stratified by metastatic stage, region, and baseline LDH.||||1.025|0.696|0.086
72474336|NCT00864253|144472915|SUPERIORITY_OR_OTHER_LEGACY||Response Rate Ratio|1.305||||0.239|TWO_SIDED|95.0|0.837|2.035|||Chi-squared|||||2.035|0.837|0.239
72474337|NCT00864253|144472916|SUPERIORITY_OR_OTHER_LEGACY||Response Rate Ratio|1.442||||0.004|TWO_SIDED|95.0|1.123|1.582|||Chi-squared|||||1.582|1.123|0.004
72474338|NCT00864253|144472917|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|2.201||||0.057|TWO_SIDED|95.0|0.959|5.053|||Log Rank|||||5.053|0.959|0.057
72474339|NCT02206061|144472933|OTHER|Repeated measure analyses testing the overall treatment effect were performed by fitting the Generalized Estimating Equation (GEE) with SFD at the three follow-up time points (3, 5, 7 months) as the dependent variable and treatment as independent variable. Normal error and identity link was specified and standard error was calculated using Sandwich estimator. Baseline SFDs, poverty level, and the presence of smokers in the home were controlled in the regression model.|Mean Difference (Net)|0.9|STANDARD_DEVIATION|2.6|<|0.05|TWO_SIDED||||||Regression, Linear|||||||<.05
72474340|NCT02193490|144472956|OTHER|||||||0.001|||||||Kruskal-Wallis|||||||0.001
72474341|NCT02193490|144472957|OTHER|||||||0.078|||||||Kruskal-Wallis|||||||0.078
72474342|NCT02193490|144472958|OTHER||||||<|0.001|||||||Kruskal-Wallis|||||||<0.001
72474343|NCT02628028|144472973|SUPERIORITY|||||||0.473|||||||Regression, Logistic|||||||0.473
72474344|NCT02628028|144472973|SUPERIORITY|||||||0.67|||||||Regression, Logistic|||||||0.670
72474345|NCT02628028|144472973|SUPERIORITY|||||||0.823|||||||Regression, Logistic|||||||0.823
72474346|NCT02628028|144472974|SUPERIORITY|||||||0.743|||||||Regression, Logistic|||||||0.743
72398331|NCT04483011|144303022|SUPERIORITY||Mean Difference (Net)|-1037.92|STANDARD_DEVIATION|1590.74||0.013|TWO_SIDED|||||p \< 0.05|Wilcoxon (Mann-Whitney)||The p value in RiaGev group at Day 8 over Day 1 is reported.|A comparison before and after RiaGev supplementation.||||0.013
72398332|NCT04483011|144303022|SUPERIORITY||Mean Difference (Net)|-302.08|STANDARD_DEVIATION|1427.42||0.382|TWO_SIDED|||||p \> 0.05|Wilcoxon (Mann-Whitney)||The p value in Comparator group at Day 8 over Day 1 is reported.|A comparison before before and after supplementation with Comparator.||||0.382
72474347|NCT02628028|144472974|SUPERIORITY|||||||0.124|||||||Regression, Logistic|||||||0.124
72474348|NCT02628028|144472974|SUPERIORITY|||||||0.858|||||||Regression, Logistic|||||||0.858
72474349|NCT02628028|144472975|SUPERIORITY|||||||0.199|||||||Regression, Logistic|||||||0.199
72474350|NCT02628028|144472975|SUPERIORITY|||||||0.028|||||||Regression, Logistic|||||||0.028
72474351|NCT02628028|144472975|SUPERIORITY|||||||0.863|||||||Regression, Logistic|||||||0.863
72474352|NCT02628028|144472976|SUPERIORITY||Mean Difference (Final Values)|-0.04|STANDARD_ERROR_OF_MEAN|0.25||0.863|TWO_SIDED|95.0|-0.53|0.44|||Mixed-effects Model for Repeated Measure|||||0.44|-0.53|0.863
72474353|NCT02628028|144472976|SUPERIORITY||Mean Difference (Final Values)|0.17|STANDARD_ERROR_OF_MEAN|0.25||0.503|TWO_SIDED|95.0|-0.32|0.65|||Mixed-effects Model for Repeated Measure|||||0.65|-0.32|0.503
72474354|NCT02628028|144472976|SUPERIORITY||Mean Difference (Final Values)|-0.27|STANDARD_ERROR_OF_MEAN|0.25||0.289|TWO_SIDED|95.0|-0.77|0.23|||Mixed-effects Model for Repeated Measure|||||0.23|-0.77|0.289
72474355|NCT02628028|144472977|SUPERIORITY|||||||0.626|||||||Regression, Logistic|||||||0.626
72398333|NCT04483011|144303023|SUPERIORITY||Mean Difference (Net)|-135.13|STANDARD_DEVIATION|2153.66||0.793|TWO_SIDED|||||p \> 0.05|Wilcoxon (Mann-Whitney)||The p value in RiaGev group at Day 8 over Day 1 baseline is reported.|A comparison between before and after RiaGev supplementation||||0.793
72398334|NCT04483011|144303023|SUPERIORITY||Mean Difference (Net)|-134.79|STANDARD_DEVIATION|1830.16||0.758|TWO_SIDED|||||p \> 0.05|Wilcoxon (Mann-Whitney)||The p value in Comparator group at Day 8 over Day 1 baseline is reported.|A comparison between before and after supplementation with Comparator.||||0.758
72474356|NCT02628028|144472977|SUPERIORITY|||||||0.418|||||||Regression, Logistic|||||||0.418
72474357|NCT02628028|144472977|SUPERIORITY|||||||0.951|||||||Regression, Logistic|||||||0.951
72474358|NCT02628028|144472978|SUPERIORITY|||||||0.905|||||||Regression, Logistic|||||||0.905
72474359|NCT02628028|144472978|SUPERIORITY|||||||0.069|||||||Regression, Logistic|||||||0.069
72474360|NCT02628028|144472978|SUPERIORITY|||||||0.547|||||||Regression, Logistic|||||||0.547
72474361|NCT02145468|144472980|SUPERIORITY||Hazard Ratio (HR)|1.16||||0.238|TWO_SIDED|95.0|0.91|1.47|||Log Rank||Hazard ratio and CI are estimated using a Cox proportional hazard regression model stratified by baseline STEMI/NSTEMI status with treatment as the only covariate. A hazard ratio \<1 indicates a lower risk with the treatment compared with placebo.|||1.47|0.91|0.238
72474362|NCT02145468|144472981|SUPERIORITY||Hazard Ratio (HR)|1.11||||0.329|TWO_SIDED|95.0|0.9|1.38|||Log Rank||"Hazard ratio and CI are estimated using a Cox proportional hazard regression model stratified by baseline STEMI/NSTEMI status with treatment as the only covariate. A hazard ratio \<1 indicates a lower risk.~with the treatment compared with placebo."|||1.38|0.90|0.329
72474363|NCT02145468|144472982|SUPERIORITY||Hazard Ratio (HR)|1.13||||0.338|TWO_SIDED|95.0|0.88|1.47|||Log Rank||Hazard ratio and CI are estimated using a Cox proportional hazard regression model stratified by baseline STEMI/NSTEMI status with treatment as the only covariate. A hazard ratio \<1 indicates a lower risk with the treatment compared with placebo.|CV death or MI, Placebo Vs Losmapimod 7.5 mg BID at Week 12||1.47|0.88|0.338
72474364|NCT02145468|144472982|SUPERIORITY||Hazard Ratio (HR)|1.1||||0.41|TWO_SIDED|95.0|0.88|1.38|||Log Rank||Hazard ratio and CI are estimated using a Cox proportional hazard regression model stratified by baseline STEMI/NSTEMI status with treatment as the only covariate. A hazard ratio \<1 indicates a lower risk with the treatment compared with placebo.|CV death or MI, Placebo Vs Losmapimod 7.5 mg BID at Week 24||1.38|0.88|0.410
72474365|NCT02145468|144472983|SUPERIORITY||Hazard Ratio (HR)|1.09||||0.472|TWO_SIDED|95.0|0.86|1.38|||Log Rank||Hazard ratio and CI are estimated using a Cox proportional hazard regression model stratified by baseline STEMI/NSTEMI status with treatment as the only covariate. A hazard ratio \<1 indicates a lower risk with the treatment compared with placebo.|CV death, MI or hospitalization for HF, Placebo Vs Losmapimod 7.5 mg BID at Week 12||1.38|0.86|0.472
72474366|NCT02145468|144472984|SUPERIORITY||Hazard Ratio (HR)|1.14|||||TWO_SIDED|95.0|0.91|1.44|||Log Rank||Hazard ratio and CI are estimated using a Cox proportional hazard regression model stratified by baseline STEMI/NSTEMI status with treatment as the only covariate. A hazard ratio \<1 indicates a lower risk with the treatment compared with placebo.|Composite of arterial CV events (CV death, MI, SRI-UR or stroke), Placebo Vs Losmapimod 7.5 mg BID at Week 12||1.44|0.91|
72474367|NCT02145468|144472985|SUPERIORITY||Hazard Ratio (HR)|1.08||||0.505|TWO_SIDED|95.0|0.86|1.36|||Log Rank||Hazard ratio and CI are estimated using a Cox proportional hazard regression model stratified by baseline STEMI/NSTEMI status with treatment as the only covariate. A hazard ratio \<1 indicates a lower risk with the treatment compared with placebo.|Composite of coronary events (CHD death, MI, SRI-UR or any unplanned coronary artery revascularization), Placebo Vs Losmapimod 7.5 mg BID at Week 12||1.36|0.86|0.505
72474368|NCT02145468|144472986|SUPERIORITY||Hazard Ratio (HR)|0.9||||0.536|TWO_SIDED|95.0|0.64|1.26|||Log Rank||Hazard ratio and CI are estimated using a Cox proportional hazard regression model stratified by baseline STEMI/NSTEMI status with treatment as the only covariate. A hazard ratio \<1 indicates a lower risk with the treatment compared with placebo.|Composite of CV death or hospitalization for HF, Placebo Vs Losmapimod 7.5 mg BID at Week 12||1.26|0.64|0.536
72474369|NCT02145468|144472986|SUPERIORITY||Hazard Ratio (HR)|0.92||||0.6|TWO_SIDED|95.0|0.69|1.24|||Log Rank||Hazard ratio and CI are estimated using a Cox proportional hazard regression model stratified by baseline STEMI/NSTEMI status with treatment as the only covariate. A hazard ratio \<1 indicates a lower risk with the treatment compared with placebo.|Composite of CV death or hospitalization for HF, Placebo Vs Losmapimod 7.5 mg BID at Week 24||1.24|0.69|0.6
72474370|NCT02145468|144472987|SUPERIORITY||Hazard Ratio (HR)|1.12||||0.356|TWO_SIDED|95.0|0.88|1.43|||Log Rank||Hazard ratio and CI are estimated using a Cox proportional hazard regression model stratified by baseline STEMI/NSTEMI status with treatment as the only covariate. A hazard ratio \<1 indicates a lower risk with the treatment compared with placebo.|Composite of CV death, MI or stroke, Placebo Vs Losmapimod 7.5 mg BID at Week 12||1.43|0.88|0.356
72474371|NCT02145468|144472988|SUPERIORITY||Hazard Ratio (HR)|1.11||||0.329|TWO_SIDED|95.0|0.9|1.39|||Log Rank||Hazard ratio and CI are estimated using a Cox proportional hazard regression model stratified by baseline STEMI/NSTEMI status with treatment as the only covariate. A hazard ratio \<1 indicates a lower risk with the treatment compared with placebo.|Composite of CV death, MI, SRI-UR, stroke or hospitalization for HF, Placebo Vs Losmapimod 7.5 mg BID at Week 12||1.39|0.9|0.329
72507251|NCT03151148|144546500|SUPERIORITY||Geometric mean ratio (GMR)|0.214||||0.06|TWO_SIDED|95.0|0.0427|1.0702|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Change from baseline is based on the difference in log10 post-baseline and log10 baseline values. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs. Non-lesional within TMT at Day 4~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||1.0702|0.0427|0.060
72507252|NCT03151148|144546500|SUPERIORITY||Geometric mean ratio (GMR)|0.182||||0.038|TWO_SIDED|95.0|0.0363|0.91|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Change from baseline is based on the difference in log10 post-baseline and log10 baseline values. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs. Non-lesional within TMT at Day 7~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||0.9100|0.0363|0.038
72507253|NCT03151148|144546500|SUPERIORITY||Geometric mean ratio (GMR)|0.329||||0.179|TWO_SIDED|95.0|0.065|1.6691|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Change from baseline is based on the difference in log10 post-baseline and log10 baseline values. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs. Non-lesional within TMT at Day 8~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||1.6691|0.0650|0.179
72565938|NCT03465436|144662839|NON_INFERIORITY|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|-5.7|||||TWO_SIDED|90.0|-7.57|-3.82|||Mixed Models Analysis|||1.5 hours postdose||-3.82|-7.57|
72507254|NCT03151148|144546500|SUPERIORITY||Geometric mean ratio (GMR)|0.136||||0.015|TWO_SIDED|95.0|0.0271|0.6805|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Change from baseline is based on the difference in log10 post-baseline and log10 baseline values. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs. Non-lesional within TMT at Day 11~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||0.6805|0.0271|0.015
72565939|NCT03465436|144662839|NON_INFERIORITY|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|-4.47|||||TWO_SIDED|90.0|-6.64|-2.3|||Mixed Models Analysis|||2 hours postdose||-2.30|-6.64|
72565940|NCT03465436|144662839|NON_INFERIORITY|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|-4.53|||||TWO_SIDED|90.0|-6.87|-2.19|||Mixed Models Analysis|||2.5 hours postdose||-2.19|-6.87|
72565941|NCT03465436|144662839|NON_INFERIORITY|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|-2.74|||||TWO_SIDED|90.0|-4.9|-0.59|||Mixed Models Analysis|||3 hours postdose||-0.59|-4.90|
72565942|NCT03465436|144662839|NON_INFERIORITY|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|-1.74|||||TWO_SIDED|90.0|-3.86|0.39|||Mixed Models Analysis|||3.5 hours postdose||0.39|-3.86|
72565943|NCT03465436|144662839|NON_INFERIORITY|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|-1.66|||||TWO_SIDED|90.0|-3.77|0.44|||Mixed Models Analysis|||4 hours postdose||0.44|-3.77|
72623091|NCT01385995|144776487|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.4||||0.1|TWO_SIDED|95.0|-5.2|0.5|||Regression, Linear|Adjusted for period, baseline level of the outcome variable, BMI, AHI, gender and race.||Based on an intent-to-treat approach, a linear mixed effect model was used to estimate the association between therapy and measures of insulin indices, in this case fasting insulin, between CPAP and sham-CPAP, stratified for the most severe sleep apnea group (Apnea-Hypopnea Index (AHI) \>=30) in order to assess whether the differences in the effect of CPAP on outcomes were observed according to sleep apnea severity. N=23.||0.5|-5.2|0.10
72398335|NCT04483011|144303024|SUPERIORITY||Mean Difference (Net)|70.2|STANDARD_DEVIATION|123.89||0.003|TWO_SIDED|||||p \< 0.05|Wilcoxon (Mann-Whitney)||The p value in RiaGev group at Day 5 over Day 1 is reported.|A comparison between before and after RiaGev supplementation||||0.003
72474372|NCT02145468|144472989|SUPERIORITY||Hazard Ratio (HR)|1.14||||0.285|TWO_SIDED|95.0|0.89|1.47|||Log Rank||Hazard ratio and CI are estimated using a Cox proportional hazard regression model stratified by baseline STEMI/NSTEMI status with treatment as the only covariate. A hazard ratio \<1 indicates a lower risk with the treatment compared with placebo.|Composite of CHD death, MI or SRI-UR, Placebo Vs Losmapimod 7.5 mg BID at Week 12||1.47|0.89|0.285
72474373|NCT02145468|144472990|SUPERIORITY||Hazard Ratio (HR)|1.12||||0.401|TWO_SIDED|95.0|0.86|1.46|||Log Rank||Hazard ratio and CI are estimated using a Cox proportional hazard regression model stratified by baseline STEMI/NSTEMI status with treatment as the only covariate. A hazard ratio \<1 indicates a lower risk with the treatment compared with placebo.|Composite of CHD death or MI, Placebo Vs Losmapimod 7.5 mg BID at Week 12||1.46|0.86|0.401
72474374|NCT02145468|144472991|SUPERIORITY||Hazard Ratio (HR)|1.14||||0.295|TWO_SIDED|95.0|0.89|1.44|||Log Rank||Hazard ratio and CI are estimated using a Cox proportional hazard regression model stratified by baseline STEMI/NSTEMI status with treatment as the only covariate. A hazard ratio \<1 indicates a lower risk with the treatment compared with placebo.|Composite of all-cause death, MI or SRI-UR,Placebo Vs Losmapimod 7.5 mg BID at Week 12||1.44|0.89|0.295
72474375|NCT02145468|144472992|SUPERIORITY||Hazard Ratio (HR)|1.11||||0.412|TWO_SIDED|95.0|0.86|1.43|||Log Rank||Hazard ratio and CI are estimated using a Cox proportional hazard regression model stratified by baseline STEMI/NSTEMI status with treatment as the only covariate. A hazard ratio \<1 indicates a lower risk with the treatment compared with placebo.|Composite of all-cause death or MI, Placebo Vs Losmapimod 7.5 mg BID at Week 12||1.43|0.86|0.412
72474376|NCT02145468|144472993|SUPERIORITY||Hazard Ratio (HR)|1.11||||0.469|TWO_SIDED|95.0|0.83|1.49|||Log Rank||Hazard ratio and CI are estimated using a Cox proportional hazard regression model stratified by baseline STEMI/NSTEMI status with treatment as the only covariate. A hazard ratio \<1 indicates a lower risk with the treatment compared with placebo.|Composite of CV death, type I (spontaneous) MI or SRI-UR, Placebo Vs Losmapimod 7.5 mg BID at Week 12||1.49|0.83|0.469
72474377|NCT02145468|144472994|SUPERIORITY||Hazard Ratio (HR)|1.07||||0.664|TWO_SIDED|95.0|0.78|1.48|||Log Rank||Hazard ratio and CI are estimated using a Cox proportional hazard regression model stratified by baseline STEMI/NSTEMI status with treatment as the only covariate. A hazard ratio \<1 indicates a lower risk with the treatment compared with placebo.|Composite of CV death or type I (spontaneous) MI, Placebo Vs Losmapimod 7.5 mg BID at Week 12||1.48|0.78|0.664
72565944|NCT03465436|144662839|NON_INFERIORITY|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|-1.11|||||TWO_SIDED|90.0|-3.17|0.94|||Mixed Models Analysis|||6 hours postdose||0.94|-3.17|
72565945|NCT03465436|144662839|NON_INFERIORITY|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|-2.47|||||TWO_SIDED|90.0|-4.58|-0.35|||Mixed Models Analysis|||8 hours postdose||-0.35|-4.58|
72565946|NCT03465436|144662839|NON_INFERIORITY|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|-2.15|||||TWO_SIDED|90.0|-3.87|-0.43|||Mixed Models Analysis|||12 hours postdose||-0.43|-3.87|
72565947|NCT03465436|144662839|NON_INFERIORITY|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|0.79|||||TWO_SIDED|90.0|-1.14|2.72|||Mixed Models Analysis|||24 hours postdose||2.72|-1.14|
72565948|NCT03465436|144662839|NON_INFERIORITY|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|-4.64|||||TWO_SIDED|90.0|-6.57|-2.71|||Mixed Models Analysis|||30 minutes postdose||-2.71|-6.57|
72565949|NCT03465436|144662839|NON_INFERIORITY|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|-2.49|||||TWO_SIDED|90.0|-4.59|-0.39|||Mixed Models Analysis|||1 hour postdose||-0.39|-4.59|
72565950|NCT03465436|144662839|NON_INFERIORITY|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|-0.96|||||TWO_SIDED|90.0|-3.02|1.09|||Mixed Models Analysis|||1.5 hours postdose||1.09|-3.02|
72474378|NCT02145468|144472995|SUPERIORITY||Hazard Ratio (HR)|0.57||||0.13|TWO_SIDED|95.0|0.27|1.19|||Log Rank||Hazard ratio and CI are estimated using a Cox proportional hazard regression model stratified by baseline STEMI/NSTEMI status with treatment as the only covariate. A hazard ratio \<1 indicates a lower risk with the treatment compared with placebo.|Participants with first occurrence of definite or probable stent thrombosis, Placebo Vs Losmapimod 7.5 mg BID at Week 12||1.19|0.27|0.130
72474379|NCT02145468|144472996|SUPERIORITY||Odds Ratio (OR)|1.03||||0.744|TWO_SIDED|95.0|0.84|1.27|||Wald chi-squared||Odds ratio is estimated using a logistic regression model stratified by baseline STEMI/NSTEMI status with treatment as the only covariate. An odds ratio \<1 indicates a lower risk with the treatment compared with placebo.|||1.27|0.84|0.744
72474380|NCT02145468|144472997|SUPERIORITY||Hazard Ratio (HR)|0.8||||0.309|TWO_SIDED|95.0|0.53|1.22|||Log Rank||Hazard ratio and CI are estimated using a Cox proportional hazard regression model stratified by baseline STEMI/NSTEMI status with treatment as the only covariate. A hazard ratio \<1 indicates a lower risk with the treatment compared with placebo.|Participants with all-cause mortality, Placebo Vs Losmapimod 7.5 mg BID at Week 12||1.22|0.53|0.309
72474381|NCT02145468|144472998|SUPERIORITY||Hazard Ratio (HR)|0.83||||0.398|TWO_SIDED|95.0|0.53|1.28|||Log Rank||Hazard ratio and CI are estimated using a Cox proportional hazard regression model stratified by baseline STEMI/NSTEMI status with treatment as the only covariate. A hazard ratio \<1 indicates a lower risk with the treatment compared with placebo.|CV death events, Placebo Vs Losmapimod 7.5 mg BID at Week 12||1.28|0.53|0.398
72474382|NCT02145468|144472998|SUPERIORITY||Hazard Ratio (HR)|0.8||||0.264|TWO_SIDED|95.0|0.55|1.18|||Log Rank||Hazard ratio and CI are estimated using a Cox proportional hazard regression model stratified by baseline STEMI/NSTEMI status with treatment as the only covariate. A hazard ratio \<1 indicates a lower risk with the treatment compared with placebo.|CV death events, Placebo Vs Losmapimod 7.5 mg BID at Week 24||1.18|0.55|0.264
72474383|NCT02145468|144472999|SUPERIORITY||Hazard Ratio (HR)|0.76||||0.251|TWO_SIDED|95.0|0.47|1.22|||Log Rank||Hazard ratio and CI are estimated using a Cox proportional hazard regression model stratified by baseline STEMI/NSTEMI status with treatment as the only covariate. A hazard ratio \<1 indicates a lower risk with the treatment compared with placebo.|CHD death events, Placebo Vs Losmapimod 7.5 mg BID at Week 12||1.22|0.47|0.251
72474384|NCT02145468|144473000|SUPERIORITY||Hazard Ratio (HR)|1.23||||0.182|TWO_SIDED|95.0|0.91|1.67|||Log Rank||Hazard ratio and CI are estimated using a Cox proportional hazard regression model stratified by baseline STEMI/NSTEMI status with treatment as the only covariate. A hazard ratio \<1 indicates a lower risk with the treatment compared with placebo.|Myocardial infarction (fatal and non-fatal) events, Placebo Vs Losmapimod 7.5 mg BID at Week 12||1.67|0.91|0.182
72474385|NCT02145468|144473000|SUPERIORITY||Hazard Ratio (HR)|1.21||||0.158|TWO_SIDED|95.0|0.93|1.58|||Log Rank||Hazard ratio and CI are estimated using a Cox proportional hazard regression model stratified by baseline STEMI/NSTEMI status with treatment as the only covariate. A hazard ratio \<1 indicates a lower risk with the treatment compared with placebo.|Myocardial infarction (fatal and non-fatal) events, Placebo Vs Losmapimod 7.5 mg BID at Week 24||1.58|0.93|0.158
72474386|NCT02145468|144473001|SUPERIORITY||Hazard Ratio (HR)|1.34||||0.21|TWO_SIDED|95.0|0.85|2.12|||Log Rank||Hazard ratio and CI are estimated using a Cox proportional hazard regression model stratified by baseline STEMI/NSTEMI status with treatment as the only covariate. A hazard ratio \<1 indicates a lower risk with the treatment compared with placebo.|Type I (spontaneous) MI events, Placebo Vs Losmapimod 7.5 mg BID at Week 12||2.12|0.85|0.21
72565951|NCT03465436|144662839|NON_INFERIORITY|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|1.64|||||TWO_SIDED|90.0|-0.46|3.73|||Mixed Models Analysis|||2 hours postdose||3.73|-0.46|
72565952|NCT03465436|144662839|NON_INFERIORITY|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|1.61|||||TWO_SIDED|90.0|-0.59|3.81|||Mixed Models Analysis|||2.5 hours postdose||3.81|-0.59|
72565953|NCT03465436|144662839|NON_INFERIORITY|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|2.41|||||TWO_SIDED|90.0|0.25|4.57|||Mixed Models Analysis|||3 hours postdose||4.57|0.25|
72474387|NCT02145468|144473002|SUPERIORITY||Hazard Ratio (HR)|1.14||||0.697|TWO_SIDED|95.0|0.58|2.24|||Log Rank||Hazard ratio and CI are estimated using a Cox proportional hazard regression model stratified by baseline STEMI/NSTEMI status with treatment as the only covariate. A hazard ratio \<1 indicates a lower risk with the treatment compared with placebo.|SRI-UR events, Placebo Vs Losmapimod 7.5 mg BID at Week 12||2.24|0.58|0.697
72474388|NCT02145468|144473003|SUPERIORITY||Hazard Ratio (HR)|0.95||||0.883|TWO_SIDED|95.0|0.46|1.96|||Log Rank||Hazard ratio and CI are estimated using a Cox proportional hazard regression model stratified by baseline STEMI/NSTEMI status with treatment as the only covariate. A hazard ratio \<1 indicates a lower risk with the treatment compared with placebo.|Stroke (fatal and non-fatal) events, Placebo Vs Losmapimod 7.5 mg BID at Week 12||1.96|0.46|0.883
72474389|NCT02145468|144473004|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.457|TWO_SIDED|95.0|0.54|1.32|||Log Rank||Hazard ratio and CI are estimated using a Cox proportional hazard regression model stratified by baseline STEMI/NSTEMI status with treatment as the only covariate. A hazard ratio \<1 indicates a lower risk with the treatment compared with placebo.|Hospitalization for HF, Placebo Vs Losmapimod 7.5 mg BID at Week 12||1.32|0.54|0.457
72474390|NCT02145468|144473004|SUPERIORITY||Hazard Ratio (HR)|0.94||||0.736|TWO_SIDED|95.0|0.63|1.38|||Log Rank||Hazard ratio and CI are estimated using a Cox proportional hazard regression model stratified by baseline STEMI/NSTEMI status with treatment as the only covariate. A hazard ratio \<1 indicates a lower risk with the treatment compared with placebo.|Hospitalization for HF, Placebo Vs Losmapimod 7.5 mg BID at Week 24||1.38|0.63|0.736
72474391|NCT02145468|144473005|SUPERIORITY||Hazard Ratio (HR)|1.11||||0.581|TWO_SIDED|95.0|0.77|1.59|||Log Rank||Hazard ratio and CI are estimated using a Cox proportional hazard regression model stratified by baseline STEMI/NSTEMI status with treatment as the only covariate. A hazard ratio \<1 indicates a lower risk with the treatment compared with placebo.|Any unplanned coronary revascularization, Placebo Vs Losmapimod 7.5 mg BID at Week 12||1.59|0.77|0.581
72474392|NCT04157400|144473006|OTHER||||||<|0.01|||||||Kruskal-Wallis|||||||<0.01
72474393|NCT04157400|144473007|OTHER||||||<|0.001|||||||ANOVA|||||||<0.001
72565954|NCT03465436|144662839|NON_INFERIORITY|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|4.3|||||TWO_SIDED|90.0|2.48|6.12|||Mixed Models Analysis|||3.5 hours postdose||6.12|2.48|
72474394|NCT04157400|144473008|OTHER||||||||||||||||||Segments of EMG recorded during walking at self-selected walking speed were used to investigate complexity of muscle synergies using a nonnegative matrix factorization (NNMF) algorithm (MATLAB®, Mathworks, Natick, MA). The approach involves calculation of an mxt matrix of the original EMG data (EMG0), where m represents the number of muscles being measured and t represents a time base normalized to percentage of gait cycle. The algorithm also calculates two surrogate matrices, mxn and nxt, where n is the amplitude of muscle activation. The product of the surrogate matrices are considered a reconstruction of EMG (EMGr). EMGr for each module is then compared to EMG0 by finding the variability accounted for (VAF). A threshold necessary for module classification was chosen to be 90% for all conditions (8 muscles + 6 phases of gait) based on similar studies in the literature. Classifications were not increased unless the higher module VAF was at least 5% higher than the preceding module.|||
72474395|NCT00186888|144473027|SUPERIORITY_OR_OTHER_LEGACY||Binomial Proportion|88.9|||||TWO_SIDED|95.0|71.3|96.9||||||||96.9|71.3|
72474396|NCT00186888|144473028|SUPERIORITY_OR_OTHER_LEGACY||Binomial Proportion|91.7|||||TWO_SIDED|95.0|65.1|99.6||||||||99.6|65.1|
72474397|NCT00186888|144473029|SUPERIORITY_OR_OTHER_LEGACY|||||||0.452||95.0|||||ANOVA|||CYP3A4\*1B: The null hypothesis is there is not a statistically significant difference between the genotype groups.||||0.452
72474398|NCT00186888|144473029|SUPERIORITY_OR_OTHER_LEGACY|||||||0.106||95.0|||||ANOVA|||CYP3A5\*3: The null hypothesis is there is not a statistically significant difference between the genotype groups.||||0.106
72474399|NCT00186888|144473030|SUPERIORITY_OR_OTHER_LEGACY|||||||0.245||95.0|||||ANOVA|||BCRP 1143: The null hypothesis is there is not a statistically significant difference between the genotype groups.||||0.245
72474400|NCT00186888|144473030|SUPERIORITY_OR_OTHER_LEGACY|||||||0.297||95.0|||||ANOVA|||BCRP 15622: The null hypothesis is there is not a statistically significant difference between the genotype groups.||||0.297
72474401|NCT00186888|144473030|SUPERIORITY_OR_OTHER_LEGACY|||||||0.372||95.0|||||ANOVA|||BCRP Exon 2: The null hypothesis is there is not a statistically significant difference between the genotype groups.||||0.372
72474402|NCT00186888|144473030|SUPERIORITY_OR_OTHER_LEGACY|||||||0.844||95.0|||||ANOVA|||BCRP Exon 5: The null hypothesis is there is not a statistically significant difference between the genotype groups.||||0.844
72474403|NCT00186888|144473030|SUPERIORITY_OR_OTHER_LEGACY|||||||0.616||95.0|||||ANOVA|||Pgp Exon 21: The null hypothesis is there is not a statistically significant difference between the genotype groups.||||0.616
72507255|NCT03151148|144546500|SUPERIORITY||Geometric mean ratio (GMR)|0.302||||0.309|TWO_SIDED|95.0|0.0299|3.0493|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Change from baseline is based on the difference in log10 post-baseline and log10 baseline values. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs. Non-lesional within Placebo at Day 0~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||3.0493|0.0299|0.309
72398336|NCT04483011|144303024|SUPERIORITY||Mean Difference (Net)|15.55|STANDARD_DEVIATION|88.62||0.766|TWO_SIDED|||||p \> 0.05|Wilcoxon (Mann-Whitney)||The p value in Comparator group at Day 5 over Day 1 is reported.|A comparison between before and after supplementation with Comparator.||||0.766
72474404|NCT00186888|144473030|SUPERIORITY_OR_OTHER_LEGACY|||||||0.424||95.0|||||ANOVA|||Pgp Exon 26: The null hypothesis is there is not a statistically significant difference between the genotype groups.||||0.424
72474405|NCT04711837|144473064|NON_INFERIORITY|Non-inferiority margin equals to -8%|Risk Difference (RD)|-0.0057|STANDARD_ERROR_OF_MEAN|0.0246|||TWO_SIDED|95.0|-0.054|0.042||Non-inferiority margin equals to -8%: 95% CI; (-5.4%, 4.2%)|Farrington-Manning method|||||0.042|-0.054|
72474406|NCT02344290|144473100|SUPERIORITY||Hazard Ratio (HR)|0.64|||||TWO_SIDED|95.0|0.48|0.84|||||Hazard ratio is shown as pitavastatin/placebo. Two-sided 95% repeated confidence interval that adjusts for interim looks according to the realized Lan and DeMets implementation of the O'Brien-Fleming sequential stopping boundary is presented.|||0.84|0.48|
72474407|NCT02344290|144473101|SUPERIORITY||Hazard Ratio (HR)|0.56|||||TWO_SIDED|95.0|0.36|0.87|||||Hazard ratio is shown as pitavastatin/placebo.|||0.87|0.36|
72474408|NCT02344290|144473102|SUPERIORITY||Hazard Ratio (HR)|0.62|||||TWO_SIDED|95.0|0.4|0.97|||||Hazard ratio is shown as pitavastatin/placebo.|||0.97|0.40|
72565955|NCT03465436|144662839|NON_INFERIORITY|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|5.15|||||TWO_SIDED|90.0|3.02|7.27|||Mixed Models Analysis|||4 hours postdose||7.27|3.02|
72565956|NCT03465436|144662839|NON_INFERIORITY|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|2.77|||||TWO_SIDED|90.0|0.75|4.79|||Mixed Models Analysis|||6 hours postdose||4.79|0.75|
72398337|NCT04483011|144303025|SUPERIORITY||Mean Difference (Net)|24.01|STANDARD_DEVIATION|58.2||0.029|TWO_SIDED|||||p \< 0.05|ANCOVA||The p value between RiaGev and Comparator groups at Day 5 is reported.|A comparison between RiaGev and Comparator groups after 7-day supplementation.||||0.029
72474409|NCT02344290|144473103|SUPERIORITY||Hazard Ratio (HR)|0.67|||||TWO_SIDED|95.0|0.11|4.02|||||Hazard ratio is shown as pitavastatin/placebo.|||4.02|0.11|
72474410|NCT02344290|144473104|SUPERIORITY||Hazard Ratio (HR)|0.7|||||TWO_SIDED|95.0|0.35|1.38|||||Hazard ratio is shown as pitavastatin/placebo.|||1.38|0.35|
72474411|NCT02344290|144473105|SUPERIORITY||Hazard Ratio (HR)|0.67|||||TWO_SIDED|95.0|0.44|1.03|||||Hazard ratio is shown as pitavastatin/placebo.|||1.03|0.44|
72474412|NCT02344290|144473106|SUPERIORITY||Hazard Ratio (HR)|0.62|||||TWO_SIDED|95.0|0.36|1.05|||||||Hazard ratio is shown as pitavastatin/placebo.|1.05|0.36|
72474413|NCT02344290|144473108|SUPERIORITY||Hazard Ratio (HR)|0.0|||||TWO_SIDED|95.0|0.0|0.54|||||||Hazard ratio is shown as pitavastatin/placebo. Estimation of the confidence interval used a Bayes analysis with a non-informative prior using adaptive rejection Metropolis sampling. In this case, the interval shown is a 95% highest posterior density (HPD) interval.|0.54|0.00|
72474414|NCT02344290|144473109|SUPERIORITY||Hazard Ratio (HR)|0.77|||||TWO_SIDED|95.0|0.64|0.94|||||Hazard ratio is shown as pitavastatin/placebo.|||0.94|0.64|
72474415|NCT02344290|144473110|SUPERIORITY||Hazard Ratio (HR)|0.88|||||TWO_SIDED|95.0|0.7|1.12|||||Hazard ratio is shown as pitavastatin/placebo.|||1.12|0.70|
72474416|NCT02344290|144473111|SUPERIORITY||Hazard Ratio (HR)|0.92|||||TWO_SIDED|95.0|0.76|1.13|||||Hazard ratio is shown as pitavastatin/placebo.|||1.13|0.76|
72398338|NCT04483011|144303026|SUPERIORITY||Mean Difference (Net)|-0.16|STANDARD_DEVIATION|0.32||0.034|TWO_SIDED|||||p \< 0.05|ANCOVA||The p value between RiaGev and Comparator groups at Day 5 is reported.|A comparison between RiaGev and Comparator groups.||||0.034
72474417|NCT02344290|144473112|SUPERIORITY||Hazard Ratio (HR)|0.93|||||TWO_SIDED|95.0|0.71|1.2|||||Hazard ratio is shown as pitavastatin/placebo.|||1.20|0.71|
72474418|NCT02344290|144473113|SUPERIORITY||Hazard Ratio (HR)|0.94|||||TWO_SIDED|95.0|0.68|1.31|||||Hazard ratio is shown as pitavastatin/placebo.|||1.31|0.68|
72474419|NCT02344290|144473114|SUPERIORITY||Hazard Ratio (HR)|0.6|||||TWO_SIDED|95.0|0.14|2.51|||||Hazard ratio is shown as pitavastatin/placebo.|||2.51|0.14|
72474420|NCT02344290|144473115|SUPERIORITY||Hazard Ratio (HR)|0.92|||||TWO_SIDED|95.0|0.42|2.02|||||Hazard ratio is shown as pitavastatin/placebo.|||2.02|0.42|
72474421|NCT02344290|144473116|SUPERIORITY||Incidence rate ratio|1.0|||||TWO_SIDED|95.0|0.9|1.1|||||Incidence rate ratio is shown as pitavastatin/placebo.|||1.10|0.90|
72474422|NCT02344290|144473117|SUPERIORITY||Incidence rate ratio|1.29|||||TWO_SIDED|95.0|1.07|1.57|||||Incidence rate ratio is shown as pitavastatin/placebo.|||1.57|1.07|
72474423|NCT02344290|144473118|SUPERIORITY||Incidence rate ratio|1.58|||||TWO_SIDED|95.0|1.14|2.19|||||Incidence rate ratio is shown as pitavastatin/placebo.|||2.19|1.14|
72474424|NCT02344290|144473119|SUPERIORITY||Incidence rate ratio|0.75|||||TWO_SIDED|95.0|0.17|3.37|||||Incidence rate ratio is shown as pitavastatin/placebo.|||3.37|0.17|
72474425|NCT02344290|144473120|SUPERIORITY||Incidence rate ratio|1.34|||||TWO_SIDED|95.0|0.56|3.18|||||Incidence rate ratio is shown as pitavastatin/placebo.|||3.18|0.56|
72474426|NCT02344290|144473121|SUPERIORITY||Incidence rate ratio|1.04|||||TWO_SIDED|95.0|0.97|1.12|||||Incidence rate ratio is shown as pitavastatin/placebo.|||1.12|0.97|
72474427|NCT02344290|144473124|SUPERIORITY||Incidence rate ratio|0.75|||||TWO_SIDED|95.0|0.52|1.08|||||Incidence rate ratio is shown as pitavastatin/placebo.|||1.08|0.52|
72474428|NCT02344290|144473125|SUPERIORITY||Incidence rate ratio|1.05|||||TWO_SIDED|95.0|0.96|1.16|||||Incidence rate ratio is shown as pitavastatin/placebo.|||1.16|0.96|
72474429|NCT02344290|144473126|SUPERIORITY||Mean Difference (Net)|-4.3||||0.04|TWO_SIDED|95.0|-8.6|-0.1|||Regression, Linear||Treatment group difference was estimated as baseline-adjusted mean difference in change at year 2, using linear regression.|||-0.1|-8.6|0.04
72474430|NCT02344290|144473127|SUPERIORITY||Risk Ratio (RR)|0.67||||0.003|TWO_SIDED|95.0|0.52|0.88|||Chi-squared||Treatment effect was estimated as relative risk (pitavastatin/placebo), adjusted for presence of NCP at entry.|||0.88|0.52|0.003
72474431|NCT02344290|144473128|SUPERIORITY||Mean Difference (Net)|-4.3|||||TWO_SIDED|95.0|-9.2|0.62|||||Treatment group difference was estimated as baseline-adjusted difference in mean change at year 2, using linear regression.|||0.62|-9.2|
72474432|NCT02344290|144473129|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Comparison of LpPla2 Levels at Month 24||||<0.001
72474433|NCT02344290|144473130|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Comparison of Change in LpPla2 from Baseline at Month 24||||<0.001
72474434|NCT02344290|144473131|SUPERIORITY|||||||0.02|||||||Wilcoxon (Mann-Whitney)|||Comparison of hsCRP Levels at Month 24||||0.02
72474435|NCT02344290|144473132|SUPERIORITY|||||||0.09|||||||Wilcoxon (Mann-Whitney)|||Comparison of Change in hsCRP from Baseline at Month 24||||0.09
72474436|NCT02344290|144473133|SUPERIORITY|||||||0.65|||||||Wilcoxon (Mann-Whitney)|||Comparison of soluble CD163 Levels at Month 24.||||0.65
72474437|NCT02344290|144473134|SUPERIORITY|||||||0.88|||||||Wilcoxon (Mann-Whitney)|||Comparison of Change in soluble CD163 from Baseline at Month 24||||0.88
72474438|NCT02344290|144473135|SUPERIORITY|||||||0.98|||||||Regression, Cox|Treatment effect modification by sex was evaluated via interaction of treatment and sex in the Cox proportional hazards regression model.||Evaluation of treatment effect modification by sex (i.e. pitavastatin effect differing in females compared to males).||||0.98
72474439|NCT02344290|144473135|SUPERIORITY||Hazard Ratio (HR)|0.63|||||TWO_SIDED|95.0|0.39|1.04|||||Hazard ratio is shown as pitavastatin/placebo among females.|Evaluation of pitavastatin effect among females.||1.04|0.39|
72474440|NCT02344290|144473135|SUPERIORITY||Hazard Ratio (HR)|0.64|||||TWO_SIDED|95.0|0.48|0.86|||||Hazard ratio is shown as pitavastatin/placebo among males.|Evaluation of pitavastatin effect among males.||0.86|0.48|
72474441|NCT02344290|144473136|SUPERIORITY|||||||0.14|||||||Regression, Cox|Treatment effect modification by race was evaluated via interaction of treatment and race in the Cox proportional hazards regression model.||Evaluation of treatment effect modification by race (i.e. pitavastatin effect differing between races).||||0.14
72474442|NCT02344290|144473136|SUPERIORITY||Hazard Ratio (HR)|0.22|||||TWO_SIDED|95.0|0.09|0.59||||||Pitavastatin effect among Asians from subgroup analysis by race.|Hazard ratio is shown as pitavastatin/placebo among Asians.|0.59|0.09|
72474443|NCT02344290|144473136|SUPERIORITY||Hazard Ratio (HR)|0.66|||||TWO_SIDED|95.0|0.46|0.96|||||Hazard ratio is shown as pitavastatin/placebo among Blacks.|Pitavastatin effect among Blacks from subgroup analysis by race.||0.96|0.46|
72474444|NCT02344290|144473136|SUPERIORITY||Hazard Ratio (HR)|0.74|||||TWO_SIDED|95.0|0.49|1.13|||||Hazard ratio is shown as pitavastatin/placebo among Whites.|Pitavastatin effect among Whites from subgroup analysis by race.||1.13|0.49|
72474445|NCT02344290|144473136|SUPERIORITY||Hazard Ratio (HR)|0.87|||||TWO_SIDED|95.0|0.36|2.1||||||Pitavastatin effect among Other race from subgroup analysis by race.|Hazard ratio is shown as pitavastatin/placebo among Other race.|2.10|0.36|
72474446|NCT03826030|144473159|SUPERIORITY|||||||0.39|||||||Mixed Models Analysis|||The null hypothesis was no overall difference in FM-UE scale change between the three groups on day 15. The change in FM-UE was modelled using a linear mixed-effects repeated measures model adjusted for visit (ie, day 15, day 45, and day 105), treatment group, treatment group by visit interaction, baseline FM-UE, time from stroke (30-90 vs. 91-180 days), and enrolment site. An AR(1) autocorrelation structure was used for visit, and variance components structure for sites.||||0.39
72565957|NCT03465436|144662839|NON_INFERIORITY|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|1.75|||||TWO_SIDED|90.0|-0.55|4.05|||Mixed Models Analysis|||8 hours postdose||4.05|-0.55|
72474447|NCT05014568|144473163|SUPERIORITY||Risk Ratio, log|2.6|||<|0.0001|TWO_SIDED|95.0|1.66|4.09|||Cochran-Mantel-Haenszel|Stratified by Baseline vIGA-AD Score and Age Group|Adjusted logit-based estimate of the common relative risk of success (Tapinarof Cream 1%/Vehicle Cream) over all strata. Multiple imputation p-value is for null hypothesis that the log (Relative Risk) equals 0.|H0: The proportion of subjects who achieve a vIGA-AD score of clear (0) or almost clear (1) and at least a 2-grade reduction from Baseline at Week 8 is equal between tapinarof cream, 1% and vehicle cream; H1: The proportion of subjects who achieve a vIGA-AD score of clear (0) or almost clear (1) and at least a 2-grade reduction from Baseline at Week 8 is different between the tapinarof cream, 1% and vehicle cream.||4.09|1.66|<0.0001
72398339|NCT04483011|144303027|SUPERIORITY||Mean Difference (Net)|-8.33|STANDARD_DEVIATION|12.99||0.014|TWO_SIDED|||||p \< 0.05|Wilcoxon (Mann-Whitney)||The p value in RiaGev group at Day 5 over Day 1 is reported.|A comparison between before and after RiaGev supplementation.||||0.014
72398340|NCT04483011|144303027|SUPERIORITY||Mean Difference (Net)|-2.56|STANDARD_DEVIATION|5.66||0.049|TWO_SIDED|||||p \< 0.05|Wilcoxon (Mann-Whitney)||The p value in Comparator group at Day 5 over Day 1 is reported.|A comparison between before and after supplementation with Comparator.||||0.049
72398341|NCT03045081|144303031|OTHER|Generalized estimating equations (GEE) were used to test this hypothesis. GEE allows for the analysis of repeated measures with unknown covariance structure and uses all available data that participants provide, even if follow-up data are missing (ie, intent-to-treat analysis). Models for the entire study sample and for only those who provided outcome data at all study time points (0, 3, 6 months; i.e., as treated 'completer' analysis) were evaluated (see Statistical Analysis 2).|||||<|0.05||||||Wald χ2 p-values \< 0.05 considered statistically significant for group x time interactions.|Wald χ2|Intent-to-treat analysis (full sample)||We hypothesized that we would observe a group (usual care vs PTSM) by time (0, 3, 6 months) interaction, such that the PTSM group would demonstrate improvement in pain self efficacy over time compared to the usual care group.||||<0.05
72474448|NCT05014568|144473164|SUPERIORITY||Risk Ratio, log|2.17|||<|0.0001|TWO_SIDED|95.0|1.57|3.0|||Cochran-Mantel-Haenszel|Stratified by vIGA-AD score at Baseline (vIGA-AD scores of 3 or 4) and age group (2-6 yrs, 7-11 yrs, 12-17 yrs, 18+ yrs)|Adjusted logit-based estimate of the common relative risk of success (Tapinarof Cream 1%/Vehicle Cream) over all strata. Multiple imputation p-value is for null hypothesis that the log (Relative Risk) equals 0.|||3.00|1.57|<0.0001
72474449|NCT05014568|144473165|SUPERIORITY||Least squares mean difference|-6.17|STANDARD_ERROR_OF_MEAN|0.657|<|0.0001|TWO_SIDED|95.0|-7.69|-4.66|||ANCOVA|age\*vIGA cohort and treatment as categorical covariates, and baseline %BSA as a continuous covariate||||-4.66|-7.69|<0.0001
72474450|NCT05014568|144473166|SUPERIORITY||Risk Ratio, log|3.74|||<|0.0001|TWO_SIDED|95.0|1.98|7.09|||Cochran-Mantel-Haenszel|Stratified by Baseline vIGA-AD Score and Age Group|Adjusted logit-based estimate of the common relative risk of success (Tapinarof Cream 1%/Vehicle Cream) over all strata. Multiple imputation p-value is for null hypothesis that the log (Relative Risk) equals 0.|||7.09|1.98|<0.0001
72507256|NCT03151148|144546500|SUPERIORITY||Geometric mean ratio (GMR)|0.372||||0.401|TWO_SIDED|95.0|0.0369|3.7569|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Change from baseline is based on the difference in log10 post-baseline and log10 baseline values. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs. Non-lesional within Placebo at Day 4~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||3.7569|0.0369|0.401
72507257|NCT03151148|144546500|SUPERIORITY||Geometric mean ratio (GMR)|0.591||||0.655|TWO_SIDED|95.0|0.0586|5.9658|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Change from baseline is based on the difference in log10 post-baseline and log10 baseline values. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs. Non-lesional within Placebo at Day 7~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||5.9658|0.0586|0.655
72507258|NCT03151148|144546500|SUPERIORITY||Geometric mean ratio (GMR)|0.43||||0.488|TWO_SIDED|95.0|0.0395|4.6836|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Change from baseline is based on the difference in log10 post-baseline and log10 baseline values. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs. Non-lesional within Placebo at Day 8~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||4.6836|0.0395|0.488
72565958|NCT03465436|144662839|NON_INFERIORITY|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|1.75|||||TWO_SIDED|90.0|-0.19|3.69|||Mixed Models Analysis|||12 hours postdose||3.69|-0.19|
72474451|NCT05014568|144473167|SUPERIORITY||Risk Ratio, log|1.54||||0.0366|TWO_SIDED|95.0|1.03|2.31|||Cochran-Mantel-Haenszel|Stratified by Baseline vIGA-AD Score and Age Group|Adjusted logit-based estimate of the common relative risk of success (Tapinarof Cream 1%/Vehicle Cream) over all strata. Multiple imputation p-value is for null hypothesis that the log (Relative Risk) equals 0.|||2.31|1.03|0.0366
72565959|NCT03465436|144662839|NON_INFERIORITY|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|-0.48|||||TWO_SIDED|90.0|-2.44|1.48|||Mixed Models Analysis|||24 hours postdose||1.48|-2.44|
72565960|NCT03465436|144662839|SUPERIORITY||LS Mean|7.07|||||TWO_SIDED|90.0|4.72|9.41|||Mixed Models Analysis|||30 minutes postdose||9.41|4.72|
72565961|NCT03465436|144662839|SUPERIORITY||LS Mean|11.81|||||TWO_SIDED|90.0|9.94|13.69|||Mixed Models Analysis|||1 hour postdose||13.69|9.94|
72565962|NCT03465436|144662839|SUPERIORITY||LS Mean|10.95|||||TWO_SIDED|90.0|9.16|12.74|||Mixed Models Analysis|||1.5 hours postdose||12.74|9.16|
72474452|NCT04893460|144473168|SUPERIORITY|This model is a paired t-test that tests for change in cognitive dissonance from baseline to after the Cost activity|Mean Difference (Final Values)|-1.09|STANDARD_ERROR_OF_MEAN|0.33||0.003|TWO_SIDED||||||t-test, 2 sided|||||||.003
72565963|NCT03465436|144662839|SUPERIORITY||LS Mean|11.5|||||TWO_SIDED|90.0|9.5|13.43|||Mixed Models Analysis|||2 hours postdose||13.43|9.5|
72565964|NCT03465436|144662839|SUPERIORITY||LS Mean|10.81|||||TWO_SIDED|90.0|8.9|12.71|||Mixed Models Analysis|||2.5 hours postdose||12.71|8.9|
72474453|NCT04893460|144473168|SUPERIORITY||Mean Difference (Final Values)|-2.1|STANDARD_ERROR_OF_MEAN|0.44|<|0.001|TWO_SIDED||||||t-test, 2 sided|||This model is a paired t-test that tests for change in cognitive dissonance from baseline to after the Quit Letter activity||||<.001
72474454|NCT04893460|144473168|SUPERIORITY||Mean Difference (Final Values)|-1.44|STANDARD_ERROR_OF_MEAN|0.41||0.004|TWO_SIDED||||||t-test, 2 sided|||This model is a paired t-test that tests for change in cognitive dissonance from baseline to after the Pitfalls activity||||.004
72565965|NCT03465436|144662839|SUPERIORITY||LS Mean|12.35|||||TWO_SIDED|90.0|10.42|14.28|||Mixed Models Analysis|||3 hours postdose||14.28|10.42|
72565966|NCT03465436|144662839|SUPERIORITY||LS Mean|12.65|||||TWO_SIDED|90.0|10.76|14.54|||Mixed Models Analysis|||3.5 hours postdose||14.54|10.76|
72565967|NCT03465436|144662839|SUPERIORITY||LS Mean|11.17|||||TWO_SIDED|90.0|9.23|13.1|||Mixed Models Analysis|||4 hours postdose||13.10|9.23|
72565968|NCT03465436|144662839|SUPERIORITY||LS Mean|8.12|||||TWO_SIDED|90.0|6.02|10.22|||Mixed Models Analysis|||6 hours postdose||10.22|6.02|
72474455|NCT04893460|144473168|SUPERIORITY||Mean Difference (Final Values)|-0.91|STANDARD_ERROR_OF_MEAN|0.48||0.098|TWO_SIDED||||||t-test, 2 sided|||This model is a paired t-test that tests for change in cognitive dissonance from baseline to after the Smoke Free activity||||.098
72474456|NCT04893460|144473168|SUPERIORITY||Mean Difference (Final Values)|-1.46|STANDARD_ERROR_OF_MEAN|0.68||0.042|TWO_SIDED||||||t-test, 2 sided|||This model is a paired t-test that tests for change in cognitive dissonance from baseline to after the Letter to Youth activity||||.042
72474457|NCT04893460|144473168|SUPERIORITY||Mean Difference (Final Values)|-0.25|STANDARD_ERROR_OF_MEAN|0.22||0.364|TWO_SIDED||||||t-test, 2 sided|||This model is a paired t-test that tests for change in cognitive dissonance from baseline to 6 weeks post baseline.||||.364
72474458|NCT04893460|144473169|SUPERIORITY||median pairwise average|17.67|||<|0.001|TWO_SIDED||||||Wilcoxson Signed Rank Test|||The non-parametric Wilcoxon signed-rank test was used to evaluate whether participants were smoking fewer cigarettes per day.||||<.001
72474459|NCT04893460|144473170|SUPERIORITY|This model is a paired t-test that tests for change in readiness to quit smoking from baseline to after the Cost activity|Mean Difference (Net)|-0.12|STANDARD_ERROR_OF_MEAN|0.42||0.776|TWO_SIDED||||||t-test, 2 sided|||||||.776
72474460|NCT04893460|144473170|SUPERIORITY|This model is a paired t-test that tests for change in readiness to quit smoking from baseline to after the Quit Latter activity|Mean Difference (Final Values)|-0.72|STANDARD_ERROR_OF_MEAN|0.45||0.219|TWO_SIDED||||||t-test, 2 sided|||||||.219
72474461|NCT04893460|144473170|SUPERIORITY|This model is a paired t-test that tests for change in readiness to quit smoking from baseline to after the Pitfalls activity|Mean Difference (Final Values)|-1.29|STANDARD_ERROR_OF_MEAN|0.55||0.043|TWO_SIDED||||||t-test, 2 sided|||||||.043
72565969|NCT03465436|144662839|SUPERIORITY||LS Mean|8.1|||||TWO_SIDED|90.0|6.01|10.19|||Mixed Models Analysis|||8 hours postdose||10.19|6.01|
72565970|NCT03465436|144662839|SUPERIORITY||LS Mean|6.26|||||TWO_SIDED|90.0|4.23|8.28|||Mixed Models Analysis|||12 hours postdose||8.28|4.23|
72565971|NCT03465436|144662839|SUPERIORITY||LS Mean|5.74|||||TWO_SIDED|90.0|3.47|8.01|||Mixed Models Analysis|||24 hours postdose||8.01|3.47|
72565972|NCT03465436|144662840|SUPERIORITY||LS Mean|32.89|||||TWO_SIDED|90.0|11.5|54.28|||Mixed Models Analysis|||30 minutes postdose||54.28|11.50|
72565973|NCT03465436|144662840|SUPERIORITY||LS Mean|100.15|||||TWO_SIDED|90.0|77.81|122.5|||Mixed Models Analysis|||1 hour postdose||122.50|77.81|
72565974|NCT03465436|144662840|SUPERIORITY||LS Mean|107.11|||||TWO_SIDED|90.0|83.31|130.91|||Mixed Models Analysis|||1.5 hours postdose||130.91|83.31|
72565975|NCT03465436|144662840|SUPERIORITY||LS Mean|74.48|||||TWO_SIDED|90.0|56.32|92.63|||Mixed Models Analysis|||2 hours postdose||92.63|56.32|
72565976|NCT03465436|144662840|SUPERIORITY||LS Mean|89.19|||||TWO_SIDED|90.0|68.77|109.61|||Mixed Models Analysis|||2.5 hours postdose||109.61|68.77|
72565977|NCT03465436|144662840|SUPERIORITY||LS Mean|74.98|||||TWO_SIDED|90.0|55.41|94.55|||Mixed Models Analysis|||3 hours postdose||94.55|55.41|
72565978|NCT03465436|144662840|SUPERIORITY||LS Mean|52.83|||||TWO_SIDED|90.0|36.03|69.63|||Mixed Models Analysis|||3.5 hours postdose||69.63|36.03|
72565979|NCT03465436|144662840|SUPERIORITY||LS Mean|42.1|||||TWO_SIDED|90.0|24.86|59.35|||Mixed Models Analysis|||4 hours postdose||59.35|24.86|
72565980|NCT03465436|144662840|SUPERIORITY||LS Mean|62.61|||||TWO_SIDED|90.0|42.39|82.83|||Mixed Models Analysis|||6 hours postdose||82.83|42.39|
72565981|NCT03465436|144662840|SUPERIORITY||LS Mean|56.05|||||TWO_SIDED|90.0|32.49|79.61|||Mixed Models Analysis|||8 hours postdose||79.61|32.49|
72565982|NCT03465436|144662840|SUPERIORITY||LS Mean|35.71|||||TWO_SIDED|90.0|11.79|59.63|||Mixed Models Analysis|||12 hours postdose||59.63|11.79|
72565983|NCT03465436|144662840|SUPERIORITY||LS Mean|-4.59|||||TWO_SIDED|90.0|-24.66|15.47|||Mixed Models Analysis|||24 hours postdose||15.47|-24.66|
72565984|NCT03465436|144662840|SUPERIORITY||LS Mean|56.53|||||TWO_SIDED|90.0|36.72|76.35|||Mixed Models Analysis|||30 minutes postdose||76.35|36.72|
72565985|NCT03465436|144662840|SUPERIORITY||LS Mean|103.3|||||TWO_SIDED|90.0|83.88|122.72|||Mixed Models Analysis|||1 hour postdose||122.72|83.88|
72565986|NCT03465436|144662840|SUPERIORITY||LS Mean|94.21|||||TWO_SIDED|90.0|75.15|113.26|||Mixed Models Analysis|||1.5 hours postdose||113.26|75.15|
72565987|NCT03465436|144662840|SUPERIORITY||LS Mean|83.49|||||TWO_SIDED|90.0|67.98|99.0|||Mixed Models Analysis|||2 hours postdose||99.00|67.98|
72565988|NCT03465436|144662840|SUPERIORITY||LS Mean|103.64|||||TWO_SIDED|90.0|87.28|120.0|||Mixed Models Analysis|||2.5 hours postdose||120.00|87.28|
72565989|NCT03465436|144662840|SUPERIORITY||LS Mean|89.26|||||TWO_SIDED|90.0|71.24|107.29|||Mixed Models Analysis|||3 hours postdose||107.29|71.24|
72565990|NCT03465436|144662840|SUPERIORITY||LS Mean|65.29|||||TWO_SIDED|90.0|48.28|82.3|||Mixed Models Analysis|||3.5 hours postdose||82.30|48.28|
72565991|NCT03465436|144662840|SUPERIORITY||LS Mean|52.85|||||TWO_SIDED|90.0|36.1|69.6|||Mixed Models Analysis|||4 hours postdose||69.60|36.10|
72398342|NCT03045081|144303031|OTHER|Generalized estimating equations (GEE) were used to test this hypothesis.|||||<|0.05||||||Wald χ2 values \< 0.05 considered statistically significant for group x time interactions.|Wald χ2|Study 'completers' only||We hypothesized that we would observe a group (usual care vs PTSM) by time (0, 3, 6 months) interaction, such that the PTSM group would demonstrate improvement in chronic pain self-efficacy over time compared to the usual care group. This analysis was limited to those participants who provided data at each of the study time points ('completer analysis').||||<0.05
72398343|NCT03045081|144303032|OTHER|Generalized estimating equations (GEE) were used to test this hypothesis. Main effects of group and time, and group × time interactions were evaluated. Models for the entire study sample and for only those who provided outcome data at all study time points (0, 3, 6 months; 'study completers') were evaluated (see Statistical Analysis 2).||||||0.068||||||Wald χ2 p-values \< 0.05 considered statistically significant for group x time interaction|Wald χ2|Intent-to-treat analysis (full sample)||We hypothesized that we would observe a group (usual care vs PTSM) by time (0, 3, 6 months) interaction, such that the PTSM group would demonstrate improvement in chronic pain acceptance - Activity Engagement - over time compared to the usual care group. Note: this questionnaire has 2 subscales, Activity Engagement and Pain Willingness. Intent-to-treat and as treated analyses were conducted for each subscale.||||0.068
72474462|NCT04893460|144473170|SUPERIORITY|This model is a paired t-test that tests for change in readiness to quit smoking from baseline to after the Smoke Free activity|Mean Difference (Final Values)|-0.98|STANDARD_ERROR_OF_MEAN|0.67||0.219|TWO_SIDED||||||t-test, 2 sided|||||||.219
72474463|NCT04893460|144473170|SUPERIORITY|This model is a paired t-test that tests for change in readiness to quit smoking from baseline to after the Letter to Youth activity|Mean Difference (Final Values)|-1.41|STANDARD_ERROR_OF_MEAN|0.54||0.11|TWO_SIDED||||||t-test, 2 sided|||||||.110
72474464|NCT04893460|144473170|SUPERIORITY|This model is a paired t-test that tests for change in readiness to quit smoking from baseline to 6 week post baseline assessment|Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.26||0.868|TWO_SIDED||||||t-test, 2 sided|||||||.868
72474465|NCT01325311|144473283|SUPERIORITY_OR_OTHER|||||||0.922|TWO_SIDED||||||t-test, 2 sided|||Using the Student t-test. If the normality assumption is tenuous, an appropriate transformation of the data such as logarithm will be considered for Student t-test or a nonparametric test such as Wilcoxon rank-sum test will be used for comparison.||||0.922
72474466|NCT01732822|144473298|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.02||||0.65|TWO_SIDED|95.0|0.92|1.13||The hypothesis will be tested at the 4.94% two-sided significance level to account for the planned interim analysis with the overall type I error preserved at 5%. A hierarchical test sequence will be used to address the issue of multiple testing|Regression, Cox|||||1.13|0.92|0.650
72474467|NCT01732822|144473299|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.02||||0.738|TWO_SIDED|95.0|0.92|1.12||The hypothesis will be tested at the 4.94% two-sided significance level to account for the planned interim analysis with the overall type I error preserved at 5%. A hierarchical test sequence will be used to address the issue of multiple testing|Regression, Cox|||||1.12|0.92|0.738
72474468|NCT01732822|144473300|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.07||||0.4|TWO_SIDED|95.0|0.92|1.23||The hypothesis will be tested at the 4.94% two-sided significance level to account for the planned interim analysis with the overall type I error preserved at 5%. A hierarchical test sequence will be used to address the issue of multiple testing|Regression, Cox|||||1.23|0.92|0.400
72507259|NCT03151148|144546500|SUPERIORITY||Geometric mean ratio (GMR)|1.485||||0.737|TWO_SIDED|95.0|0.1471|14.9869|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Change from baseline is based on the difference in log10 post-baseline and log10 baseline values. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs. Non-lesional within Placebo at Day 11~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||14.9869|0.1471|0.737
72565992|NCT03465436|144662840|SUPERIORITY||LS Mean|86.09|||||TWO_SIDED|90.0|66.36|105.82|||Mixed Models Analysis|||6 hours postdose||105.82|66.36|
72398344|NCT03045081|144303032|OTHER|Generalized estimating equations (GEE) were used to test this hypothesis.|||||<|0.05||||||Wald χ2 \<0.05 considered statistically significant for group x time interaction.|Wald χ2|Study 'completers' only||We hypothesized that we would observe a group by time interaction, such that the PTSM group would demonstrate improvement in chronic pain acceptance - Activity Engagement - over time compared to the usual care group.This analysis was limited to those participants who provided data at each of the study time points ('completer' analysis).||||<0.05
72474469|NCT01732822|144473301|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.06||||0.482|TWO_SIDED|95.0|0.91|1.23||The hypothesis will be tested at the 4.94% two-sided significance level to account for the planned interim analysis with the overall type I error preserved at 5%. A hierarchical test sequence will be used to address the issue of multiple testing|Regression, Cox|||||1.23|0.91|0.482
72565993|NCT03465436|144662840|SUPERIORITY||LS Mean|80.12|||||TWO_SIDED|90.0|58.32|101.91|||Mixed Models Analysis|||8 hours postdose||101.91|58.32|
72565994|NCT03465436|144662840|SUPERIORITY||LS Mean|67.58|||||TWO_SIDED|90.0|44.64|90.51|||Mixed Models Analysis|||12 hours postdose||90.51|44.64|
72474470|NCT01732822|144473302|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.99||||0.913|TWO_SIDED|95.0|0.89|1.11||The hypothesis will be tested at the 4.94% two-sided significance level to account for the planned interim analysis with the overall type I error preserved at 5%. A hierarchical test sequence will be used to address the issue of multiple testing|Regression, Cox|||||1.11|0.89|0.913
72474471|NCT01732822|144473303|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.02||||0.724|TWO_SIDED|95.0|0.92|1.13||The hypothesis will be tested at the 4.94% two-sided significance level to account for the planned interim analysis with the overall type I error preserved at 5%. A hierarchical test sequence will be used to address the issue of multiple testing|Regression, Cox|||||1.13|0.92|0.724
72474472|NCT01732822|144473304|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.03||||0.846|TWO_SIDED|95.0|0.79|1.33||The hypothesis will be tested at the 4.94% two-sided significance level to account for the planned interim analysis with the overall type I error preserved at 5%. A hierarchical test sequence will be used to address the issue of multiple testing|Regression, Cox|||||1.33|0.79|0.846
72565995|NCT03465436|144662840|SUPERIORITY||LS Mean|7.77|||||TWO_SIDED|90.0|-10.01|25.55|||Mixed Models Analysis|||24 hours postdose||25.55|-10.01|
72474473|NCT01732822|144473305|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.95||||0.298|TWO_SIDED|95.0|0.87|1.05||The hypothesis will be tested at the 4.94% two-sided significance level to account for the planned interim analysis with the overall type I error preserved at 5%. A hierarchical test sequence will be used to address the issue of multiple testing|Regression, Cox|||||1.05|0.87|0.298
72474474|NCT01732822|144473306|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.97||||0.462|TWO_SIDED|95.0|0.9|1.05||The hypothesis will be tested at the 4.94% two-sided significance level to account for the planned interim analysis with the overall type I error preserved at 5%. A hierarchical test sequence will be used to address the issue of multiple testing|Regression, Cox|||||1.05|0.90|0.462
72474475|NCT01732822|144473307|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.01||||0.793|TWO_SIDED|95.0|0.92|1.12|||Regression, Cox|||||1.12|0.92|0.793
72474476|NCT01732822|144473308|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.0||||1|TWO_SIDED|95.0|0.92|1.09|||Regression, Cox|||||1.09|0.92|1.000
72474477|NCT01732822|144473309|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.99||||0.829|TWO_SIDED|95.0|0.91|1.08|||Regression, Cox|||||1.08|0.91|0.829
72474478|NCT01732822|144473310|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.0||||0.949|TWO_SIDED|95.0|0.92|1.08|||Regression, Cox|||||1.08|0.92|0.949
72474479|NCT01732822|144473311|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.93||||0.377|TWO_SIDED|95.0|0.78|1.1|||Regression, Cox|||||1.10|0.78|0.377
72474480|NCT01732822|144473315|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.87||||0.164|TWO_SIDED|95.0|0.71|1.06|||Regression, Cox|||||1.06|0.71|0.164
72474481|NCT01732822|144473316|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.87||||0.306|TWO_SIDED|95.0|0.67|1.14|||Regression, Cox|||||1.14|0.67|0.306
72474482|NCT01732822|144473317|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.01||||0.887|TWO_SIDED|95.0|0.93|1.09|||Regression, Cox|||||1.09|0.93|0.887
72507260|NCT03151148|144546501|SUPERIORITY||Geometric mean ratio (GMR)|0.248||||0.011|TWO_SIDED|95.0|0.0844|0.7281|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Change from baseline is based on the difference in log10 post-baseline and log10 baseline values. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs. Non-lesional within TMT at Day 0~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||0.7281|0.0844|0.011
72507261|NCT03151148|144546501|SUPERIORITY||Geometric mean ratio (GMR)|0.656||||0.44|TWO_SIDED|95.0|0.2245|1.9178|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Change from baseline is based on the difference in log10 post-baseline and log10 baseline values. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs. Non-lesional within TMT at Day 4~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||1.9178|0.2245|0.440
72565996|NCT03465436|144662840|SUPERIORITY||LS Mean|-22.02|||||TWO_SIDED|90.0|-38.44|-5.6|||Mixed Models Analysis|||30 minutes postdose||-5.60|-38.44|
72565997|NCT03465436|144662840|SUPERIORITY||LS Mean|-38.87|||||TWO_SIDED|90.0|-57.15|-20.6|||Mixed Models Analysis|||1 hour postdose||-20.60|-57.15|
72565998|NCT03465436|144662840|SUPERIORITY||LS Mean|-22.13|||||TWO_SIDED|90.0|-39.35|-4.91|||Mixed Models Analysis|||1.5 hours postdose||-4.91|-39.35|
72565999|NCT03465436|144662840|SUPERIORITY||LS Mean|-17.35|||||TWO_SIDED|90.0|-32.15|-2.56|||Mixed Models Analysis|||2 hours postdose||-2.56|-32.15|
72474483|NCT01732822|144473318|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.1||||0.489|TWO_SIDED|95.0|0.84|1.43|||Regression, Cox|||||1.43|0.84|0.489
72474484|NCT01732822|144473319|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.17||||0.138|TWO_SIDED|95.0|0.95|1.43|||Regression, Cox|||||1.43|0.95|0.138
72474485|NCT01732822|144473320|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.16||||0.139|TWO_SIDED|95.0|0.95|1.41|||Regression, Cox|||||1.41|0.95|0.139
72474486|NCT01732822|144473321|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.58|||<|0.001|TWO_SIDED|95.0|1.24|2.0|||Regression, Cox|||||2.00|1.24|<0.001
72474487|NCT00384774|144473330|SUPERIORITY_OR_OTHER_LEGACY|||||||1|||||||Fisher Exact|||Headache Response||||1.0000
72474488|NCT00384774|144473330|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0991|||||||Fisher Exact|||Headache Response||||0.0991
72474489|NCT00384774|144473330|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4851|||||||Chi-squared|||Headache Response||||0.4851
72474490|NCT00384774|144473330|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1178|||||||Chi-squared|||Headache Response||||0.1178
72474491|NCT00384774|144473330|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1093|||||||Chi-squared|||Headache Response||||0.1093
72474492|NCT00384774|144473330|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3364|||||||Fisher Exact|||Headache Response||||0.3364
72474493|NCT00568178|144473345|SUPERIORITY_OR_OTHER_LEGACY||Ratio in Geometric Mean|0.63||||0.001|TWO_SIDED|95.0|0.54|0.74|||Mixed Models Analysis|||||0.74|0.54|0.001
72474494|NCT00568178|144473346|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.4||||||95.0|-9.9|-1.0|||Mixed Models Analysis|||||-1.0|-9.9|
72474495|NCT00568178|144473347|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.6||||||95.0|-9.2|-0.1|||Mixed Models Analysis|||||-0.1|-9.2|
72474496|NCT00568178|144473348|SUPERIORITY_OR_OTHER_LEGACY||Geometric Mean Ratio|1.18|||||TWO_SIDED|95.0|0.86|1.6||No P Value was calculated for this outcome.|Mixed Models Analysis|An unstructured variance-covariance was used.||||1.60|0.86|
72474497|NCT00568178|144473349|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean|-3.8||||||95.0|-15.2|7.6||A P-Value was not calculated for this outcome.|Mixed Models Analysis|||||7.6|-15.2|
72474498|NCT02815579|144473350|SUPERIORITY||Difference in log odds|-0.08||||0.86|TWO_SIDED|95.0|-1.0|0.84|||Mixed Models Analysis|||The investigators produced a difference-in-difference estimate between baseline and year 2 using multi-level logistic regression. Units are in log odds.||0.84|-1.0|0.86
72474499|NCT02815579|144473351|SUPERIORITY||Difference in log odds|0.32||||0.23|TWO_SIDED|95.0|-0.28|0.92|||Mixed Models Analysis|||The investigators analyzed longitudinal data measured every 6 months to assess trends in the two study arms and produced a difference-in-differences estimate between baseline and year 2 using multi-level logistic regression. Units are in log odds.||0.92|-0.28|0.23
72474500|NCT02815579|144473352|SUPERIORITY||Mean Difference (Net)|1.39||||0.26|TWO_SIDED|95.0|-1.01|3.78|||Mixed Models Analysis|||The investigators analyzed longitudinal data measured every 6 months to assess trends in the two study arms and produced a difference-in-differences estimate between baseline and year 2.||3.78|-1.01|0.26
72566000|NCT03465436|144662840|SUPERIORITY||LS Mean|-1.03|||||TWO_SIDED|90.0|-18.17|16.12|||Mixed Models Analysis|||2.5 hours postdose||16.12|-18.17|
72566001|NCT03465436|144662840|SUPERIORITY||LS Mean|-4.77|||||TWO_SIDED|90.0|-21.81|12.27|||Mixed Models Analysis|||3 hours postdose||12.27|-21.81|
72566002|NCT03465436|144662840|SUPERIORITY||LS Mean|-16.56|||||TWO_SIDED|90.0|-33.36|0.24|||Mixed Models Analysis|||3.5 hours postdose||0.24|-33.36|
72398345|NCT03045081|144303032|OTHER|Generalized estimating equations (GEE) were used to test this hypothesis.||||||0.173||||||Wald χ2 \< 0.05 considered statistically significant for group x time interaction.|Wald χ2|Intent-to-treat analysis (full sample).||We hypothesized that we would observe a group by time interaction such that the PTSM group would demonstrate improvement in chronic pain acceptance - Pain Willingness - over time compared to the usual care group.||||0.173
72474501|NCT02815579|144473353|SUPERIORITY||Difference in log odds|0.84||||0.31|TWO_SIDED|95.0|-0.79|2.47|||Mixed Models Analysis|||The investigators analyzed longitudinal data measured every 6 months to assess trends in the two study arms and produced a difference-in-differences estimate between baseline and year 2 using multi-level logistic regression. Units are in log odds.||2.47|-0.79|0.31
72474502|NCT02815579|144473354|SUPERIORITY||Difference in log odds|-0.34||||0.44|TWO_SIDED|95.0|-1.22|0.53|||Mixed Models Analysis|||The investigators analyzed longitudinal data measured every 6 months to assess trends in the two study arms and produced a difference-in-differences estimate between baseline and year 2 using multi-level logistic regression. Units are in log odds.||0.53|-1.22|0.44
72474503|NCT02815579|144473355|SUPERIORITY||Mean Difference (Net)|-3.54|||<|0.001|TWO_SIDED|95.0|-4.16|-2.92|||Mixed Models Analysis|||The investigators analyzed longitudinal data measured every 6 months to assess trends in the two study arms and produced a difference-in-differences estimate between baseline and year 2.||-2.92|-4.16|<0.001
72474504|NCT02815579|144473356|SUPERIORITY||Mean Difference (Net)|-0.21||||0.02|TWO_SIDED|95.0|-0.39|-0.04|||Mixed Models Analysis|||The investigators analyzed longitudinal data measured every 6 months to assess trends in the two study arms and produced a difference-in-differences estimate between baseline and year 2.||-0.04|-0.39|0.02
72474505|NCT02815579|144473357|SUPERIORITY||Mean Difference (Net)|0.01||||0.98|TWO_SIDED|95.0|-0.82|0.84|||Mixed Models Analysis|||The investigators analyzed longitudinal data measured every 6 months to assess trends in the two study arms and produced a difference-in-differences estimate between baseline and year 2.||0.84|-0.82|0.98
72474506|NCT02815579|144473358|SUPERIORITY||Mean Difference (Net)|-0.37||||0.001|TWO_SIDED|95.0|-0.59|-0.15|||Mixed Models Analysis|||The investigators analyzed longitudinal data measured every 6 months to assess trends in the two study arms and produced a difference-in-differences estimate between baseline and year 2.||-0.15|-0.59|0.001
72474507|NCT02815579|144473359|SUPERIORITY||Difference in log odds|-0.83||||0.001|TWO_SIDED|95.0|-1.45|-0.2|||Mixed Models Analysis|||The investigators analyzed longitudinal data measured every 6 months to assess trends in the two study arms and produced a difference-in-differences estimate between baseline and year 2 using multi-level logistic regression. Units are in log odds.||-0.20|-1.45|0.001
72474508|NCT02815579|144473360|SUPERIORITY||Mean Difference (Net)|-0.42|||<|0.001|TWO_SIDED|95.0|-0.52|-0.31|||Mixed Models Analysis|||||-0.31|-0.52|<0.001
72474509|NCT00264303|144473361|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.25||||0.005||95.0|0.08|0.43|||ANCOVA|ANCOVA with treatment and pooled center as factors and baseline CIU composite score as covariate.||||0.43|0.08|0.005
72474510|NCT00264303|144473362|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.17||||0.041||95.0|0.01|0.34|||ANCOVA|ANCOVA with treatment and pooled center as factors and baseline CIU composite score as covariate||||0.34|0.01|0.041
72474511|NCT00264303|144473363|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.13||||0.004||95.0|0.04|0.22|||ANCOVA|ANCOVA with treatment and pooled center as factors and baseline pruritus severity score as covariate.||||0.22|0.04|0.004
72474512|NCT00264303|144473364|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.16||||0.002||95.0|0.06|0.26|||ANCOVA|ANCOVA with treatment and pooled center as factors and baseline pruritus duration as covariate.||||0.26|0.06|0.002
72474513|NCT00264303|144473365|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.12||||0.009||95.0|0.03|0.22|||ANCOVA|ANCOVA with treatment and pooled centers as factors and baseline pruritus duration score as covariate.||||0.22|0.03|0.009
72474514|NCT00264303|144473366|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.16|||<|0.001||95.0|0.07|0.26|||ANCOVA|ANCOVA with treatment and pooled center as factors and baseline severity as covariate.||The primary hypothesis to be tested in this study was that the clinical efficacy of Levocetirizine 5 mg is superior to that of Desloratidine 5 mg||0.26|0.07|<0.001
72474515|NCT02389452|144473367|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Paired t-test|||||||<0.0001
72566003|NCT03465436|144662840|SUPERIORITY||LS Mean|-15.29|||||TWO_SIDED|90.0|-32.94|2.37|||Mixed Models Analysis|||4 hours postdose||2.37|-32.94|
72566004|NCT03465436|144662840|SUPERIORITY||LS Mean|6.13|||||TWO_SIDED|90.0|-10.86|23.11|||Mixed Models Analysis|||6 hours postdose||23.11|-10.86|
72566005|NCT03465436|144662840|SUPERIORITY||LS Mean|2.27|||||TWO_SIDED|90.0|-15.25|19.8|||Mixed Models Analysis|||8 hours postdose||19.80|-15.25|
72566006|NCT03465436|144662840|SUPERIORITY||LS Mean|-11.95|||||TWO_SIDED|90.0|-33.46|9.56|||Mixed Models Analysis|||12 hours postdose||9.56|-33.46|
72566007|NCT03465436|144662840|SUPERIORITY||LS Mean|-0.31|||||TWO_SIDED|90.0|-17.32|16.69|||Mixed Models Analysis|||24 hours postdose||16.69|-17.32|
72566008|NCT03465436|144662841|SUPERIORITY||LS Mean|0.02|||||TWO_SIDED|90.0|-0.37|0.41|||Mixed Models Analysis|||30 minutes postdose||0.41|-0.37|
72566009|NCT03465436|144662841|SUPERIORITY||LS Mean|-0.23|||||TWO_SIDED|90.0|-0.61|0.15|||Mixed Models Analysis|||1 hour postdose||0.15|-0.61|
72566010|NCT03465436|144662841|SUPERIORITY||LS Mean|-0.12|||||TWO_SIDED|90.0|-0.47|0.23|||Mixed Models Analysis|||1.5 hours postdose||0.23|-0.47|
72566011|NCT03465436|144662841|SUPERIORITY||LS Mean|-0.44|||||TWO_SIDED|90.0|-0.81|-0.07|||Mixed Models Analysis|||2 hours postdose||-0.07|-0.81|
72566012|NCT03465436|144662841|SUPERIORITY||LS Mean|-0.55|||||TWO_SIDED|90.0|-0.95|-0.15|||Mixed Models Analysis|||2.5 hours postdose||-0.15|-0.95|
72566013|NCT03465436|144662841|SUPERIORITY||LS Mean|-0.38|||||TWO_SIDED|90.0|-0.77|0.0|||Mixed Models Analysis|||3 hours postdose||0.00|-0.77|
72566014|NCT03465436|144662841|SUPERIORITY||LS Mean|-0.41|||||TWO_SIDED|90.0|-0.72|-0.1|||Mixed Models Analysis|||3.5 hours postdose||-0.10|-0.72|
72507262|NCT03151148|144546501|SUPERIORITY||Geometric mean ratio (GMR)|0.479||||0.178|TWO_SIDED|95.0|0.164|1.4007|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Change from baseline is based on the difference in log10 post-baseline and log10 baseline values. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs. Non-lesional within TMT at Day 7~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||1.4007|0.1640|0.178
72507263|NCT03151148|144546501|SUPERIORITY||Geometric mean ratio (GMR)|0.478||||0.18|TWO_SIDED|95.0|0.1624|1.4091|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Change from baseline is based on the difference in log10 post-baseline and log10 baseline values. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs. Non-lesional within TMT at Day 8~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||1.4091|0.1624|0.180
72474516|NCT02311673|144473385|OTHER||Least Squares (LS) Mean Difference|-0.3||||0.42|TWO_SIDED|95.0|-3.1|2.5||One sided p-value.|Longitudinal mixed analysis of variance||A longitudinal mixed analysis of variance model with fixed effects for treatment, time, treatment-by-time interaction, treatment-by-baseline weight interaction, baseline weight as covariate and participant as random effect was used.|||2.5|-3.1|0.420
72474517|NCT02311673|144473385|OTHER||LS Mean Difference|-0.4||||0.348|TWO_SIDED|95.0|-2.3|1.6|||Longitudinal mixed analysis of variance|One sided p-value.|A longitudinal mixed analysis of variance model with fixed effects for treatment, time, treatment-by-time interaction, treatment-by-baseline weight interaction, baseline weight as covariate and participant as random effect was used.|||1.6|-2.3|0.348
72474518|NCT02311673|144473385|OTHER||LS Mean Difference|0.8||||0.779|TWO_SIDED|95.0|-1.3|2.9||One sided p-value.|Longitudinal mixed analysis of variance||A longitudinal mixed analysis of variance model with fixed effects for treatment, time, treatment-by-time interaction, treatment-by-baseline weight interaction, baseline weight as covariate and participant as random effect was used.|||2.9|-1.3|0.779
72507264|NCT03151148|144546501|SUPERIORITY||Geometric mean ratio (GMR)|0.357||||0.06|TWO_SIDED|95.0|0.1222|1.0441|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Change from baseline is based on the difference in log10 post-baseline and log10 baseline values. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs. Non-lesional within TMT at Day 11~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||1.0441|0.1222|0.060
72507265|NCT03151148|144546501|SUPERIORITY||Geometric mean ratio (GMR)|0.498||||0.373|TWO_SIDED|95.0|0.1068|2.3188|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Change from baseline is based on the difference in log10 post-baseline and log10 baseline values. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs. Non-lesional within Placebo at Day 0~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||2.3188|0.1068|0.373
72507266|NCT03151148|144546501|SUPERIORITY||Geometric mean ratio (GMR)|0.281||||0.106|TWO_SIDED|95.0|0.0604|1.3106|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Change from baseline is based on the difference in log10 post-baseline and log10 baseline values. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs. Non-lesional within Placebo at Day 4~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||1.3106|0.0604|0.106
72507267|NCT03151148|144546501|SUPERIORITY||Geometric mean ratio (GMR)|1.168||||0.843|TWO_SIDED|95.0|0.2507|5.4434|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Change from baseline is based on the difference in log10 post-baseline and log10 baseline values. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs. Non-lesional within Placebo at Day 7~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||5.4434|0.2507|0.843
72474519|NCT02311673|144473387|OTHER||LS Mean Difference|21.5||||0.901|TWO_SIDED|95.0|-11.8|54.8||One sided p-value.|Longitudinal mixed analysis of variance||A longitudinal mixed analysis of variance model with fixed effects for treatment, time, treatment-by-time interaction, treatment-by-baseline weight interaction, baseline weight as covariate and participant as random effect was used.|||54.8|-11.8|0.901
72474520|NCT02311673|144473387|OTHER||LS Mean Difference|-3.9||||0.362|TWO_SIDED|95.0|-26.3|18.5||One sided p-value.|Longitudinal mixed analysis of variance||A longitudinal mixed analysis of variance model with fixed effects for treatment, time, treatment-by-time interaction, treatment-by-baseline weight interaction, baseline weight as covariate and participant as random effect was used.|||18.5|-26.3|0.362
72474521|NCT02311673|144473387|OTHER||LS Mean Difference|-3.7||||0.378|TWO_SIDED|95.0|-28.0|20.5||One sided p-value.|Longitudinal mixed analysis of variance||A longitudinal mixed analysis of variance model with fixed effects for treatment, time, treatment-by-time interaction, treatment-by-baseline weight interaction, baseline weight as covariate and participant as random effect was used.|||20.5|-28.0|0.378
72474522|NCT02311673|144473388|OTHER||LS Mean Difference|20.6||||0.84|TWO_SIDED|95.0|-20.9|62.2||One sided p-value.|Longitudinal mixed analysis of variance||A longitudinal mixed analysis of variance model with fixed effects for treatment, time, treatment-by-time interaction, treatment-by-baseline weight interaction, baseline weight as covariate and participant as random effect was used.|||62.2|-20.9|0.840
72474523|NCT02311673|144473388|OTHER||LS Mean Difference|-10.2||||0.236|TWO_SIDED|95.0|-38.7|18.4||One sided p-value.|Longitudinal mixed analysis of variance||A longitudinal mixed analysis of variance model with fixed effects for treatment, time, treatment-by-time interaction, treatment-by-baseline weight interaction, baseline weight as covariate and participant as random effect was used.|||18.4|-38.7|0.236
72474524|NCT02311673|144473388|OTHER||LS Mean Difference|-13.4||||0.191|TWO_SIDED|95.0|-44.2|17.4|||Longitudinal mixed analysis of variance|One sided p-value.||||17.4|-44.2|0.191
72474525|NCT02311673|144473389|OTHER||LS Mean Difference|19.5||||0.812|TWO_SIDED|95.0|-24.8|63.8||One sided p-value.|Longitudinal mixed analysis of variance||||A longitudinal mixed analysis of variance model with fixed effects for treatment, time, treatment-by-time interaction, treatment-by-baseline weight interaction, baseline weight as covariate and participant as random effect was used.|63.8|-24.8|0.812
72474526|NCT02311673|144473389|OTHER||LS Mean Difference|-1.3||||0.464|TWO_SIDED|95.0|-29.9|27.4||One sided p-value.|Longitudinal mixed analysis of variance||A longitudinal mixed analysis of variance model with fixed effects for treatment, time, treatment-by-time interaction, treatment-by-baseline weight interaction, baseline weight as covariate and participant as random effect was used.|||27.4|-29.9|0.464
72474527|NCT02311673|144473389|OTHER||LS Mean Difference|-2.6||||0.432|TWO_SIDED|95.0|-33.6|28.4||One sided p-value.|Longitudinal mixed analysis of variance||A longitudinal mixed analysis of variance model with fixed effects for treatment, time, treatment-by-time interaction, treatment-by-baseline weight interaction, baseline weight as covariate and participant as random effect was used.|||28.4|-33.6|0.432
72474528|NCT02311673|144473390|OTHER||LS Mean Difference|49.9||||0.988|TWO_SIDED|95.0|6.7|93.2||One sided p-value.|Longitudinal mixed analysis of variance||A longitudinal mixed analysis of variance model with fixed effects for treatment, time, treatment-by-time interaction, treatment-by-baseline weight interaction, baseline weight as covariate and participant as random effect was used.|||93.2|6.7|0.988
72474529|NCT02311673|144473390|OTHER||LS Mean Difference|16.0||||0.859|TWO_SIDED|95.0|-13.7|45.6||One sided p-value.|Longitudinal mixed analysis of variance||A longitudinal mixed analysis of variance model with fixed effects for treatment, time, treatment-by-time interaction, treatment-by-baseline weight interaction, baseline weight as covariate and participant as random effect was used.|||45.6|-13.7|0.859
72566015|NCT03465436|144662841|SUPERIORITY||LS Mean|-0.35|||||TWO_SIDED|90.0|-0.66|-0.04|||Mixed Models Analysis|||4 hours postdose||-0.04|-0.66|
72566016|NCT03465436|144662841|SUPERIORITY||LS Mean|-0.54|||||TWO_SIDED|90.0|-0.98|-0.09|||Mixed Models Analysis|||6 hours postdose||-0.09|-0.98|
72474530|NCT02311673|144473390|OTHER||LS Mean Difference|22.2||||0.916|TWO_SIDED|95.0|-9.8|54.3||One sided p-value.|Longitudinal mixed analysis of variance||A longitudinal mixed analysis of variance model with fixed effects for treatment, time, treatment-by-time interaction, treatment-by-baseline weight interaction, baseline weight as covariate and participant as random effect was used.|||54.3|-9.8|0.916
72507268|NCT03151148|144546501|SUPERIORITY||Geometric mean ratio (GMR)|1.559||||0.587|TWO_SIDED|95.0|0.3122|7.7818|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Change from baseline is based on the difference in log10 post-baseline and log10 baseline values. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs. Non-lesional within Placebo at Day 8~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||7.7818|0.3122|0.587
72566017|NCT03465436|144662841|SUPERIORITY||LS Mean|-0.14|||||TWO_SIDED|90.0|-0.58|0.31|||Mixed Models Analysis|||8 hours postdose||0.31|-0.58|
72474531|NCT02311673|144473391|OTHER||LS Mean Difference|32.7||||0.943|TWO_SIDED|95.0|-8.4|73.8||One sided p-value.|Longitudinal mixed analysis of variance||A longitudinal mixed analysis of variance model with fixed effects for treatment, time, treatment-by-time interaction, treatment-by-baseline weight interaction, baseline weight as covariate and participant as random effect was used.|||73.8|-8.4|0.943
72474532|NCT02311673|144473391|OTHER||LS Mean Difference|-4.2||||0.339|TWO_SIDED|95.0|-24.4|16.1||One sided p-value.|Longitudinal mixed analysis of variance||A longitudinal mixed analysis of variance model with fixed effects for treatment, time, treatment-by-time interaction, treatment-by-baseline weight interaction, baseline weight as covariate and participant as random effect was used.|||16.1|-24.4|0.339
72474533|NCT02311673|144473391|OTHER||LS Mean Difference|1.1||||0.533|TWO_SIDED|95.0|-25.0|27.2||One sided p-value.|Longitudinal mixed analysis of variance||A longitudinal mixed analysis of variance model with fixed effects for treatment, time, treatment-by-time interaction, treatment-by-baseline weight interaction, baseline weight as covariate and participant as random effect was used.|||27.2|-25.0|0.533
72566018|NCT03465436|144662841|SUPERIORITY||LS Mean|-0.29|||||TWO_SIDED|90.0|-0.7|0.12|||Mixed Models Analysis|||12 hours postdose||0.12|-0.70|
72566019|NCT03465436|144662841|SUPERIORITY||LS Mean|0.43|||||TWO_SIDED|90.0|0.01|0.84|||Mixed Models Analysis|||24 hours postdose||0.84|0.01|
72566020|NCT03465436|144662841|SUPERIORITY||LS Mean|-0.19|||||TWO_SIDED|90.0|-0.59|0.21|||Mixed Models Analysis|||30 minutes postdose||0.21|-0.59|
72566021|NCT03465436|144662841|SUPERIORITY||LS Mean|0.48|||||TWO_SIDED|90.0|0.06|0.89|||Mixed Models Analysis|||1 hour postdose||0.89|0.06|
72566022|NCT03465436|144662841|SUPERIORITY||LS Mean|0.56|||||TWO_SIDED|90.0|0.19|0.93|||Mixed Models Analysis|||1.5 hours postdose||0.93|0.19|
72566023|NCT03465436|144662841|SUPERIORITY||LS Mean|0.4|||||TWO_SIDED|90.0|0.02|0.77|||Mixed Models Analysis|||2 hours postdose||0.77|0.02|
72566024|NCT03465436|144662841|SUPERIORITY||LS Mean|0.51|||||TWO_SIDED|90.0|0.13|0.88|||Mixed Models Analysis|||2.5 hours postdose||0.88|0.13|
72566025|NCT03465436|144662841|SUPERIORITY||LS Mean|0.33|||||TWO_SIDED|90.0|-0.05|0.71|||Mixed Models Analysis|||3 hours postdose||0.71|-0.05|
72566026|NCT03465436|144662841|SUPERIORITY||LS Mean|0.32|||||TWO_SIDED|90.0|-0.02|0.67|||Mixed Models Analysis|||3.5 hours postdose||0.67|-0.02|
72566027|NCT03465436|144662841|SUPERIORITY||LS Mean|0.5|||||TWO_SIDED|90.0|0.16|0.84|||Mixed Models Analysis|||4 hours postdose||0.84|0.16|
72507269|NCT03151148|144546501|SUPERIORITY||Geometric mean ratio (GMR)|0.707||||0.661|TWO_SIDED|95.0|0.1495|3.3426|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Change from baseline is based on the difference in log10 post-baseline and log10 baseline values. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs. Non-lesional within Placebo at Day 11~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||3.3426|0.1495|0.661
72507270|NCT03151148|144546502|SUPERIORITY||Geometric mean ratio (GMR)|1197.16|||<|0.001|TWO_SIDED|95.0|525.563|2726.953|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator.|"TMT vs Placebo on Lesional Skin at Day 0 (post-treatment)~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||2726.953|525.563|<0.001
72566028|NCT03465436|144662841|SUPERIORITY||LS Mean|-0.1|||||TWO_SIDED|90.0|-0.56|0.36|||Mixed Models Analysis|||6 hours postdose||0.36|-0.56|
72566029|NCT03465436|144662841|SUPERIORITY||LS Mean|-0.11|||||TWO_SIDED|90.0|-0.56|0.33|||Mixed Models Analysis|||8 hours postdose||0.33|-0.56|
72474534|NCT02311673|144473399|OTHER||LS Mean Difference|-0.2||||0.439|TWO_SIDED|95.0|-3.0|2.6||One sided p-value.|Longitudinal mixed analysis of variance||A longitudinal mixed analysis of variance model with fixed effects for treatment, time, treatment-by-time interaction, treatment-by-baseline weight interaction, baseline weight as covariate and participant as random effect was used.|||2.6|-3.0|0.439
72474535|NCT02311673|144473399|OTHER||LS Mean Difference|-0.3||||0.366|TWO_SIDED|95.0|-2.3|1.6||One sided p-value.|Longitudinal mixed analysis of variance||A longitudinal mixed analysis of variance model with fixed effects for treatment, time, treatment-by-time interaction, treatment-by-baseline weight interaction, baseline weight as covariate and participant as random effect was used.|||1.6|-2.3|0.366
72474536|NCT02311673|144473399|OTHER||LS Mean Difference|0.7||||0.744|TWO_SIDED|95.0|-1.4|2.8||One sided p-value.|Longitudinal mixed analysis of variance||A longitudinal mixed analysis of variance model with fixed effects for treatment, time, treatment-by-time interaction, treatment-by-baseline weight interaction, baseline weight as covariate and participant as random effect was used.|||2.8|-1.4|0.744
72474537|NCT02311673|144473400|OTHER||LS Mean Difference|1.0||||0.883|TWO_SIDED|95.0|-0.7|2.8||One sided p-value.|Longitudinal mixed analysis of variance||A longitudinal mixed analysis of variance model with fixed effects for treatment, time, treatment-by-time interaction, treatment-by-baseline weight interaction, baseline weight as covariate and participant as random effect was used.|||2.8|-0.7|0.883
72474538|NCT02311673|144473400|OTHER||LS Mean Difference|-0.2||||0.338|TWO_SIDED|95.0|-1.3|0.9||One sided p-value.|Longitudinal mixed analysis of variance||A longitudinal mixed analysis of variance model with fixed effects for treatment, time, treatment-by-time interaction, treatment-by-baseline weight interaction, baseline weight as covariate and participant as random effect was used.|||0.9|-1.3|0.338
72474539|NCT02311673|144473400|OTHER||LS Mean Difference|-0.2||||0.381|TWO_SIDED|95.0|-1.6|1.2||One sided p-value.|Longitudinal mixed analysis of variance||A longitudinal mixed analysis of variance model with fixed effects for treatment, time, treatment-by-time interaction, treatment-by-baseline weight interaction, baseline weight as covariate and participant as random effect was used.|||1.2|-1.6|0.381
72474540|NCT02311673|144473402|OTHER||LS Mean Difference|1.3||||0.679|TWO_SIDED|95.0|-4.5|7.0||One sided p-value.|Longitudinal mixed analysis of variance||A longitudinal mixed analysis of variance model with fixed effects for treatment, time, treatment-by-time interaction, treatment-by-baseline weight interaction, baseline weight as covariate and participant as random effect was used.|Statistical analysis is provided for percent change from baseline at Day 56.||7.0|-4.5|0.679
72474541|NCT02311673|144473402|OTHER||LS Mean Difference|0.7||||0.641|TWO_SIDED|95.0|-3.3|4.7||One sided p-value.|Longitudinal mixed analysis of variance||A longitudinal mixed analysis of variance model with fixed effects for treatment, time, treatment-by-time interaction, treatment-by-baseline weight interaction, baseline weight as covariate and participant as random effect was used.|Statistical analysis is provided for percent change from baseline at Day 56.||4.7|-3.3|0.641
72474542|NCT02311673|144473402|OTHER||LS Mean Difference|1.9||||0.809|TWO_SIDED|95.0|-2.6|6.4||One sided p-value.|Longitudinal mixed analysis of variance||A longitudinal mixed analysis of variance model with fixed effects for treatment, time, treatment-by-time interaction, treatment-by-baseline weight interaction, baseline weight as covariate and participant as random effect was used.|Statistical analysis is provided for percent change from baseline at Day 56.||6.4|-2.6|0.809
72474543|NCT02311673|144473403|OTHER||LS Mean Difference|0.5||||0.633|TWO_SIDED|95.0|-2.6|3.6||One sided p-value.|Longitudinal mixed analysis of variance||A longitudinal mixed analysis of variance model with fixed effects for treatment, time, treatment-by-time interaction, treatment-by-baseline weight interaction, baseline weight as covariate and participant as random effect was used.|||3.6|-2.6|0.633
72474544|NCT02311673|144473403|OTHER||LS Mean Difference|0.1||||0.528|TWO_SIDED|95.0|-2.1|2.3||One sided p-value.|Longitudinal mixed analysis of variance||A longitudinal mixed analysis of variance model with fixed effects for treatment, time, treatment-by-time interaction, treatment-by-baseline weight interaction, baseline weight as covariate and participant as random effect was used.|||2.3|-2.1|0.528
72474545|NCT02311673|144473403|OTHER||LS Mean Difference|0.5||||0.648|TWO_SIDED|95.0|-2.0|2.9||One sided p-value.|Longitudinal mixed analysis of variance||A longitudinal mixed analysis of variance model with fixed effects for treatment, time, treatment-by-time interaction, treatment-by-baseline weight interaction, baseline weight as covariate and participant as random effect was used.|||2.9|-2.0|0.648
72474546|NCT02311673|144473405|OTHER||LS Mean Difference|0.7||||0.712|TWO_SIDED|95.0|-1.8|3.1||One sided p-value.|Longitudinal mixed analysis of variance||A longitudinal mixed analysis of variance model with fixed effects for treatment, time, treatment-by-time interaction, treatment-by-baseline weight interaction, baseline weight as covariate and participant as random effect was used.|||3.1|-1.8|0.712
72474547|NCT02311673|144473405|OTHER||LS Mean Difference|-0.2||||0.414|TWO_SIDED|95.0|-1.9|1.5||One sided p-value.|Longitudinal mixed analysis of variance||A longitudinal mixed analysis of variance model with fixed effects for treatment, time, treatment-by-time interaction, treatment-by-baseline weight interaction, baseline weight as covariate and participant as random effect was used.|||1.5|-1.9|0.414
72474548|NCT02311673|144473405|OTHER||LS Mean Difference|0.6||||0.732|TWO_SIDED|95.0|-1.3|2.5||One sided p-value|Longitudinal mixed analysis of variance||A longitudinal mixed analysis of variance model with fixed effects for treatment, time, treatment-by-time interaction, treatment-by-baseline weight interaction, baseline weight as covariate and participant as random effect was used.|||2.5|-1.3|0.732
72474549|NCT01006252|144473407|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.23||||0.121||95.0||||Statistical significance was assessed at an alpha level of 0.05.|Stratified log rank|||||||0.121
72474550|NCT01006252|144473408|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.3||||0.048||95.0||||Statistical significance was assessed at an alpha level of 0.05.|Stratified log rank|Analysis adjusted for Baseline Lactate Dehydrogenase (LDH); Disease Stage; Sex; Previous Single Agent Immunotherapy Treatment; Age Group||||||0.048
72474551|NCT01006252|144473409|SUPERIORITY_OR_OTHER|||||||0.396||95.0||||Statistical significance was assessed at an alpha level of 0.05.|Unadjusted normal distribution|Unadjusted normal-distribution approximation for the difference in rates||||||0.396
72474552|NCT01006252|144473411|SUPERIORITY_OR_OTHER|||||||0.483||95.0||||Statistical significance was assessed at an alpha level of 0.05.|Unadjusted normal distribution|Unadjusted normal-distribution approximation for the difference in rates.||||||0.483
72474553|NCT01006252|144473412|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.11||||0.505||95.0||||Statistical significance was assessed at an alpha level of 0.05.|Stratified log rank|||||||0.505
72474554|NCT01006252|144473413|SUPERIORITY_OR_OTHER|||||||0.902||95.0||||P-value given for Overall Main Treatment Effect from the repeated measure model where time was a class variable. Statistical significance was assessed at an alpha level of 0.05.|Mixed Model Repeated Measures (MMRM)|MMRM analyses limited to first 4 cycles due to sparse data; data from 30-day follow-up visit coded to first cycle after last on-treatment cycle.||||||0.902
72474555|NCT01006252|144473413|SUPERIORITY_OR_OTHER|||||||0.97||95.0||||P-value given for Treatment-By-Cycle Interaction from the repeated measure model where time was a class variable. Statistical significance was assessed at an alpha level of 0.05.|Mixed Model Repeated Measures (MMRM)|MMRM analyses limited to first 4 cycles due to sparse data; data from 30-day follow-up visit coded to first cycle after last on-treatment cycle.||||||0.970
72474556|NCT01006252|144473415|SUPERIORITY_OR_OTHER|||||||0.902||95.0||||P-value given for Overall Main Treatment Effect from the repeated measure model where time was a class variable. Statistical significance was assessed at an alpha level of 0.05.|Mixed Model Repeated Measures (MMRM)|MMRM analyses limited to first 4 cycles due to sparse data; data from 30-day follow-up visit coded to first cycle after last on-treatment cycle.||||||0.902
72474557|NCT01006252|144473415|SUPERIORITY_OR_OTHER|||||||0.97||95.0||||P-value given for Overall Treatment-By-Cycle Interaction from the repeated measure model where time was a class variable. Statistical significance was assessed at an alpha level of 0.05.|Mixed Model Repeated Measures (MMRM)|MMRM analyses limited to first 4 cycles due to sparse data; data from 30-day follow-up visit coded to first cycle after last on-treatment cycle.||||||0.970
72566030|NCT03465436|144662841|SUPERIORITY||LS Mean|-0.39|||||TWO_SIDED|90.0|-0.84|0.06|||Mixed Models Analysis|||12 hours postdose||0.06|-0.84|
72566031|NCT03465436|144662841|SUPERIORITY||LS Mean|0.04|||||TWO_SIDED|90.0|-0.37|0.45|||Mixed Models Analysis|||24 hours postdose||0.45|-0.37|
72566032|NCT03465436|144662841|SUPERIORITY||LS Mean|-0.09|||||TWO_SIDED|90.0|-0.45|0.28|||Mixed Models Analysis|||30 minutes postdose||0.28|-0.45|
72566033|NCT03465436|144662841|SUPERIORITY||LS Mean|-0.1|||||TWO_SIDED|90.0|-0.46|0.27|||Mixed Models Analysis|||1 hour postdose||0.27|-0.46|
72474558|NCT01006252|144473416|SUPERIORITY_OR_OTHER|||||||0.547||95.0||||P-value given for Main Treatment Effect from the repeated measure model where time was a class variable. Statistical significance was assessed at an alpha level of 0.05.|Mixed Model Repeated Measures (MMRM)|MMRM analyses limited to first 4 cycles due to sparse data; data from 30-day follow-up visit coded to first cycle after last on-treatment cycle.||||||0.547
72474559|NCT01006252|144473416|SUPERIORITY_OR_OTHER|||||||0.414||95.0||||P-value given for Treatment-By-Cycle Interaction from the repeated measure model where time was a class variable. Statistical significance was assessed at an alpha level of 0.05.|Mixed Model Repeated Measures (MMRM)|MMRM analyses limited to first 4 cycles due to sparse data; data from 30-day follow-up visit coded to first cycle after last on-treatment cycle.||||||0.414
72474560|NCT01006252|144473418|SUPERIORITY_OR_OTHER|||||||0.547||95.0||||P-value given for Main Treatment Effect from the repeated measure model where time was a class variable. Statistical significance was assessed at an alpha level of 0.05.|Mixed Model Repeated Measures (MMRM)|MMRM analyses limited to first 4 cycles due to sparse data; data from 30-day follow-up visit coded to first cycle after last on-treatment cycle.||||||0.547
72474561|NCT01006252|144473418|SUPERIORITY_OR_OTHER|||||||0.414||95.0||||P-value given for Treatment-By-Cycle Interaction from the repeated measure model where time was a class variable. Statistical significance was assessed at an alpha level of 0.05.|Mixed Model Repeated Measures (MMRM)|MMRM analyses limited to first 4 cycles due to sparse data; data from 30-day follow-up visit coded to first cycle after last on-treatment cycle.||||||0.414
72474562|NCT02683772|144473428|NON_INFERIORITY|The method proposed for this analysis was a one-sided paired t-test using a significance level of 0.05 and a non-inferiority margin of 2 events/hour|Mean Difference (Final Values)|-4.45|STANDARD_DEVIATION|17.23||0.0134|TWO_SIDED||||||t-test, 1 sided|||||||0.0134
72474563|NCT00414908|144473436|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Non parametric ANCOVA|||The following null hypothesis was tested (μ0 and μ1 denote the treatment group means respectively in the placebo and pancrelipase delayed release capsules group): H0: μ0 = μ1 (i.e., placebo and pancrelipase delayed release capsules are equal). The hypothesis corresponded to the primary objective to show superior efficacy of pancrelipase delayed release capsules over placebo. A non-parametric ANCOVA was used because the necessary assumptions were not met for the parametric ANCOVA.||||<0.0001
72566034|NCT03465436|144662841|SUPERIORITY||LS Mean|0.25|||||TWO_SIDED|90.0|-0.1|0.6|||Mixed Models Analysis|||1.5 hours postdose||0.60|-0.10|
72566035|NCT03465436|144662841|SUPERIORITY||LS Mean|0.01|||||TWO_SIDED|90.0|-0.38|0.4|||Mixed Models Analysis|||2 hours postdose||0.40|-0.38|
72566036|NCT03465436|144662841|SUPERIORITY||LS Mean|0.02|||||TWO_SIDED|90.0|-0.34|0.37|||Mixed Models Analysis|||2.5 hours postdose||0.37|-0.34|
72474564|NCT00414908|144473437|SUPERIORITY_OR_OTHER|||||||0.0002||95.0|||||Non parametric ANCOVA|||The following null hypothesis was tested (μ0 and μ1 denote the treatment group means respectively in the placebo and pancrelipase delayed release capsules group): H0: μ0 = μ1 (i.e., placebo and pancrelipase delayed release capsules are equal). The hypothesis corresponded to the primary objective to show superior efficacy of pancrelipase delayed release capsules over placebo. A non-parametric ANCOVA was used because the necessary assumptions were not met for the parametric ANCOVA.||||0.0002
72474565|NCT00414908|144473438|SUPERIORITY_OR_OTHER||LS Means difference|-112.45|||<|0.0001||95.0|-147.04|-77.87|||ANCOVA|||"The following null hypothesis was tested (μ0 and μ1 denote the treatment group means in the placebo and pancrelipase delayed release capsules group): H0: μ0 = μ1 (i.e., placebo and pancrelipase capsules are equal).~The hypothesis was to show superior efficacy of pancrelipase delayed release capsules over placebo.~For this secondary efficacy variable, an analysis of covariance (ANCOVA) model was assumed with the treatment group as a fixed factor and the Stool fat at baseline as a covariate."||-77.87|-147.04|<0.0001
72474566|NCT00414908|144473439|SUPERIORITY_OR_OTHER||LS Means difference|-11.68|||<|0.0001||95.0|-17.3|-6.06|||ANCOVA|||"The following null hypothesis was tested (μ0 and μ1 denote the treatment group means in the placebo and pancrelipase delayed release capsules group): H0: μ0 = μ1 (i.e., placebo and pancrelipase capsules are equal).~The hypothesis was to show superior efficacy of pancrelipase delayed release capsules over placebo. For this secondary efficacy variable, an analysis of covariance (ANCOVA) model was assumed with the treatment group as a fixed factor and the Stool nitrogen at baseline as a covariate."||-6.06|-17.30|<0.0001
72474567|NCT00414908|144473440|SUPERIORITY_OR_OTHER||LS Means difference|-0.76||||0.005||95.0|-1.27|-0.24|||ANCOVA|||"The following null hypothesis was tested (μ0 and μ1 denote the treatment group means in the placebo and pancrelipase delayed release capsules group): H0: μ0 = μ1 (i.e., placebo and pancrelipase capsules are equal). The hypothesis was to show superior efficacy of pancrelipase capsules over placebo.~For this secondary efficacy variable, an analysis of covariance (ANCOVA) model was assumed with the treatment group as a fixed factor and the Stool frequency at baseline as a covariate."||-0.24|-1.27|0.005
72474568|NCT00414908|144473444|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Paired t-test|Mean difference based on all subjects combined using the paired t-test between baseline and visit 8 or early termination||||||<0.001
72474569|NCT00921687|144473476|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.53||||0.04|TWO_SIDED|95.0|1.01|2.3|||Generalized Estimating Equation||Intervention clinic (vs control clinic)|||2.30|1.01|0.04
72474570|NCT00921687|144473477|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.12||||0.44||95.0|0.84|1.49|||Generalized Estimating Equation||Intervention clinic (vs control clinic)|||1.49|0.84|0.44
72474571|NCT00316602|144473481|NON_INFERIORITY|The non-inferiority margin to show that Group 2 (Atopic Dermatitis Participants) is non-inferior to Group 1 (Healthy Participants) in terms of seroconversion rate at Week 6 was predefined as -5% for the difference in seroconversion rates.|Difference in seroconversion rates (%)|-1.2|||||ONE_SIDED|97.5|-4.3||||||||||-4.3|
72474572|NCT00626990|144473494|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.76|TWO_SIDED|99.1|0.73|1.28|||Regression, Cox|||||1.28|0.73|0.76
72474573|NCT00626990|144473494|SUPERIORITY||Hazard Ratio (HR)|0.64|||<|0.0001|TWO_SIDED|95.0|0.52|0.79|||Regression, Cox|||||0.79|0.52|<0.0001
72474574|NCT00626990|144473495|SUPERIORITY||Hazard Ratio (HR)|0.86||||0.11|TWO_SIDED|95.0|0.72|1.03|||Regression, Cox|||||1.03|0.72|0.11
72566037|NCT03465436|144662841|SUPERIORITY||LS Mean|-0.09|||||TWO_SIDED|90.0|-0.44|0.25|||Mixed Models Analysis|||3 hours postdose||0.25|-0.44|
72474575|NCT00626990|144473495|SUPERIORITY||Hazard Ratio (HR)|0.59|||<|0.0001|TWO_SIDED|95.0|0.49|0.7|||Regression, Cox|||||0.70|0.49|<0.0001
72474576|NCT01008410|144473541|SUPERIORITY|||||||0.0324||||||Threshold for significance at 0.05 level.|Regression, Logistic|||The logistic regression test was used to test for a difference in the percentages between the 2 treatment arms after adjusting for analysis center (country).||||0.0324
72474577|NCT00297427|144473557|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED||||||t-test, 2 sided|||||||0.02
72474578|NCT00297427|144473558|SUPERIORITY_OR_OTHER|||||||0.32|TWO_SIDED||||||t-test, 2 sided|||||||0.32
72474579|NCT00297427|144473559|SUPERIORITY_OR_OTHER|||||||0.16|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.16
72474580|NCT00297427|144473560|SUPERIORITY_OR_OTHER|||||||0.18|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.18
72474581|NCT00297427|144473562|SUPERIORITY_OR_OTHER|||||||0.04|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.04
72474582|NCT00297427|144473563|SUPERIORITY_OR_OTHER|||||||0.38|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.38
72474583|NCT00297427|144473564|SUPERIORITY_OR_OTHER|||||||0.43|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.43
72474584|NCT00297427|144473566|SUPERIORITY_OR_OTHER|||||||0.04|||||||Repeated measures using GEE|||||||0.04
72474585|NCT00297427|144473567|SUPERIORITY_OR_OTHER|||||||0.01|||||||Repeated measures using GEE|||||||0.01
72474586|NCT00297427|144473568|SUPERIORITY_OR_OTHER|||||||0.41|||||||Repeated measures using GEE|||||||0.41
72474587|NCT00297427|144473569|SUPERIORITY_OR_OTHER|||||||0.04||||||Bivariate (unadjusted) analysis|t-test, 2 sided|||||||0.04
72474588|NCT00297427|144473569|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.208||||0.014|TWO_SIDED|95.0|1.039|1.405|||Regression, Logistic||These are the adjusted results of a multivariate logistic regression.|||1.405|1.039|0.014
72474589|NCT00297427|144473570|SUPERIORITY_OR_OTHER|||||||0.023||||||This is the result from the bivariate (unadjusted) analysis.|t-test, 2 sided|||||||0.023
72474590|NCT00297427|144473570|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.936||||0.03|TWO_SIDED|95.0|0.881|0.994|||Regression, Logistic||These are the adjusted results from a multivariate logistic regression analysis.|||0.994|0.881|0.030
72474591|NCT00297427|144473571|SUPERIORITY_OR_OTHER|||||||0.64|||||||t-test, 2 sided|||||||0.64
72474592|NCT00297427|144473572|SUPERIORITY_OR_OTHER|||||||0.78|||||||Wilcoxon (Mann-Whitney)|||||||0.78
72474593|NCT00297427|144473574|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 1 sided|||||||<.001
72474594|NCT00297427|144473575|SUPERIORITY_OR_OTHER|||||||0.48|||||||t-test, 2 sided|||||||0.48
72474595|NCT00297427|144473576|SUPERIORITY_OR_OTHER|||||||0.86|||||||t-test, 2 sided|||||||0.86
72474596|NCT03248882|144473579|SUPERIORITY||Mean Difference (Net)|-10.7|||||TWO_SIDED|80.0|-19.4|-1.1||||||||-1.1|-19.4|
72474597|NCT03248882|144473579|SUPERIORITY||Mean Difference (Net)|-46.0|||||TWO_SIDED|80.0|-51.3|-40.1||||||||-40.1|-51.3|
72474598|NCT03248882|144473579|SUPERIORITY||Mean Difference (Net)|-52.4|||||TWO_SIDED|80.0|-57.2|-47.1||||||||-47.1|-57.2|
72474599|NCT03248882|144473579|SUPERIORITY||Mean Difference (Net)|-62.1|||||TWO_SIDED|80.0|-66.0|-57.8||||||||-57.8|-66.0|
72474600|NCT03248882|144473580|SUPERIORITY||Mean Difference (Net)|-4.4|||||TWO_SIDED|80.0|-14.0|6.3||||||||6.3|-14.0|
72474601|NCT03248882|144473580|SUPERIORITY||Mean Difference (Net)|-21.0|||||TWO_SIDED|80.0|-29.0|-12.2||||||||-12.2|-29.0|
72507271|NCT03151148|144546502|SUPERIORITY||Geometric mean ratio (GMR)|779.24|||<|0.001|TWO_SIDED|95.0|342.093|1774.996|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator.|"TMT vs Placebo on Lesional Skin at Day 4~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||1774.996|342.093|<0.001
72507272|NCT03151148|144546502|SUPERIORITY||Geometric mean ratio (GMR)|673.56|||<|0.001|TWO_SIDED|95.0|295.697|1534.265|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator.|"TMT vs Placebo on Lesional Skin at Day 7~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||1534.265|295.697|<0.001
72507273|NCT03151148|144546502|SUPERIORITY||Geometric mean ratio (GMR)|60.12|||<|0.001|TWO_SIDED|95.0|24.92|145.027|||Mixed Models Analysis|||"TMT vs Placebo on Lesional Skin at Day 8~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."|All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator.|145.027|24.920|<0.001
72507274|NCT03151148|144546502|SUPERIORITY||Geometric mean ratio (GMR)|3.79||||0.002|TWO_SIDED|95.0|1.636|8.767|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator.|"TMT vs Placebo on Lesional Skin at Day 11~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||8.767|1.636|0.002
72507275|NCT03151148|144546502|SUPERIORITY||Geometric mean ratio (GMR)|757.38|||<|0.001|TWO_SIDED|95.0|331.143|1732.242|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator.|"TMT vs Placebo on Non-lesional Skin at Day 0 (post-treatment)~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||1732.242|331.143|<0.001
72507276|NCT03151148|144546502|SUPERIORITY||Geometric mean ratio (GMR)|199.71|||<|0.001|TWO_SIDED|95.0|87.636|455.127|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator.|"TMT vs Placebo on Non-lesional Skin at Day 4~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||455.127|87.636|<0.001
72474602|NCT03248882|144473580|SUPERIORITY||Mean Difference (Net)|-25.0|||||TWO_SIDED|80.0|-32.8|-16.1||||||||-16.1|-32.8|
72474603|NCT03248882|144473580|SUPERIORITY||Mean Difference (Net)|-41.8|||||TWO_SIDED|80.0|-47.9|-35.0||||||||-35.0|-47.9|
72474604|NCT05731999|144473688|OTHER|"The hypothesis was that k = 0. If the hypothesis could be rejected (p\<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition.~Here the p-value for Dbase at 50 lux is reported."|Slope|7.11|||<|0.0001|TWO_SIDED||||||Regression, Linear|||The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + m||||<0.0001
72474605|NCT05731999|144473688|OTHER|"The hypothesis was that k = 0. If the hypothesis could be rejected (p\<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition.~Here the p-value for Dcon at 50 lux is reported."|Slope|5.98|||<|0.0001|TWO_SIDED||||||Regression, Linear|||The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + m||||<0.0001
72474606|NCT05731999|144473688|OTHER|"The hypothesis was that k = 0. If the hypothesis could be rejected (p\<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition.~Here the p-value for Ctime at 50 lux is reported."|Slope|7.17||||0.0006|TWO_SIDED||||||Regression, Linear|||The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + m||||0.0006
72474607|NCT05731999|144473688|OTHER|"The hypothesis was that k = 0. If the hypothesis could be rejected (p\<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition.~Here the p-value for Dend at 50 lux is reported."|Slope|4.75|||<|0.0001|TWO_SIDED||||||Regression, Linear|||The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + m||||<0.0001
72474608|NCT05731999|144473688|OTHER|"The hypothesis was that k = 0. If the hypothesis could be rejected (p\<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition.~Here the p-value for MCA at 50 lux is reported."|Slope|5.95||||0.0002|TWO_SIDED||||||Regression, Linear|||The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + m||||0.0002
72474609|NCT05731999|144473688|OTHER|"The hypothesis was that k = 0. If the hypothesis could be rejected (p\<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition.~Here the p-value for D2m at 500 lux is reported."|Slope|6.92||||0.0285|TWO_SIDED||||||Regression, Linear|||The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + m||||0.0285
72474610|NCT05731999|144473688|OTHER|"The hypothesis was that k = 0. If the hypothesis could be rejected (p\<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition.~Here the p-value for Dbase at 500 lux is reported."|Slope|6.99|||<|0.0001|TWO_SIDED||||||Regression, Linear|||The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + m||||<0.0001
72507277|NCT03151148|144546502|SUPERIORITY||Geometric mean ratio (GMR)|508.45|||<|0.001|TWO_SIDED|95.0|223.113|1158.715|||Mixed Models Analysis|||"TMT vs Placebo on Non-lesional Skin at Day 7~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."|All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator.|1158.715|223.113|<0.001
72507278|NCT03151148|144546502|SUPERIORITY||Geometric mean ratio (GMR)|107.86|||<|0.001|TWO_SIDED|95.0|45.568|255.313|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator.|"TMT vs Placebo on Non-lesional Skin at Day 8~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||255.313|45.568|<0.001
72507279|NCT03151148|144546502|SUPERIORITY||Geometric mean ratio (GMR)|16.09|||<|0.001|TWO_SIDED|95.0|7.058|36.657|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator.|"TMT vs Placebo on Non-lesional Skin at Day 11~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||36.657|7.058|<0.001
72507280|NCT03151148|144546503|SUPERIORITY||Geometric mean ratio (GMR)|142.89|||<|0.001|TWO_SIDED|95.0|58.484|349.119|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator.|"TMT vs Placebo on Lesional Skin at Day 0 (post-treatment)~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||349.119|58.484|<0.001
72566038|NCT03465436|144662841|SUPERIORITY||LS Mean|-0.39|||||TWO_SIDED|90.0|-0.76|-0.03|||Mixed Models Analysis|||3.5 hours postdose||-0.03|-0.76|
72566039|NCT03465436|144662841|SUPERIORITY||LS Mean|-0.38|||||TWO_SIDED|90.0|-0.73|-0.03|||Mixed Models Analysis|||4 hours postdose||-0.03|-0.73|
72474611|NCT05731999|144473688|OTHER|"The hypothesis was that k = 0. If the hypothesis could be rejected (p\<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition.~Here the p-value for Dcon at 500 lux is reported."|Slope|6.8|||<|0.0001|TWO_SIDED||||||Regression, Linear|||The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + m||||<0.0001
72566040|NCT03465436|144662841|SUPERIORITY||LS Mean|-0.6|||||TWO_SIDED|90.0|-1.03|-0.17|||Mixed Models Analysis|||6 hours postdose||-0.17|-1.03|
72474612|NCT05731999|144473688|OTHER|"The hypothesis was that k = 0. If the hypothesis could be rejected (p\<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition.~Here the p-value for Dend at 500 lux is reported."|Slope|5.94||||0.0001|TWO_SIDED||||||Regression, Linear|||The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + m||||0.0001
72474613|NCT05731999|144473688|OTHER|"The hypothesis was that k = 0. If the hypothesis could be rejected (p\<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition.~Here the p-value for MCA at 500 lux is reported."|Slope|5.85||||0.012|TWO_SIDED||||||Regression, Linear|||The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + m||||0.012
72566041|NCT03465436|144662841|SUPERIORITY||LS Mean|-0.39|||||TWO_SIDED|90.0|-0.82|0.04|||Mixed Models Analysis|||8 hours postdose||0.04|-0.82|
72566042|NCT03465436|144662841|SUPERIORITY||LS Mean|-0.31|||||TWO_SIDED|90.0|-0.7|0.09|||Mixed Models Analysis|||12 hours postdose||0.09|-0.70|
72566043|NCT03465436|144662841|SUPERIORITY||LS Mean|0.19|||||TWO_SIDED|90.0|-0.23|0.61|||Mixed Models Analysis|||24 hours postdose||0.61|-0.23|
72566044|NCT03465436|144662842|SUPERIORITY||LS Mean|-1.53|||||TWO_SIDED|90.0|-2.9|-0.16|||Mixed Models Analysis|||30 minutes postdose||-0.16|-2.90|
72566045|NCT03465436|144662842|SUPERIORITY||LS Mean|-5.09|||||TWO_SIDED|90.0|-6.29|-3.88|||Mixed Models Analysis|||1 hour postdose||-3.88|-6.29|
72566046|NCT03465436|144662842|SUPERIORITY||LS Mean|-5.57|||||TWO_SIDED|90.0|-6.81|-4.32|||Mixed Models Analysis|||1.5 hours postdose||-4.32|-6.81|
72566047|NCT03465436|144662842|SUPERIORITY||LS Mean|-4.01|||||TWO_SIDED|90.0|-5.0|-3.01|||Mixed Models Analysis|||2 hours postdose||-3.01|-5.00|
72566048|NCT03465436|144662842|SUPERIORITY||LS Mean|-4.78|||||TWO_SIDED|90.0|-5.91|-3.65|||Mixed Models Analysis|||2.5 hours postdose||-3.65|-5.91|
72566049|NCT03465436|144662842|SUPERIORITY||LS Mean|-4.14|||||TWO_SIDED|90.0|-5.2|-3.08|||Mixed Models Analysis|||3 hours postdose||-3.08|-5.20|
72566050|NCT03465436|144662842|SUPERIORITY||LS Mean|-2.94|||||TWO_SIDED|90.0|-3.87|-2.01|||Mixed Models Analysis|||3.5 hours postdose||-2.01|-3.87|
72398346|NCT03045081|144303032|OTHER|Generalized estimating equations were used to test this hypothesis.||||||0.167||||||Wald χ2 \>0.05 considered statistically significant for group x time interaction.|Wald χ2|Study 'completers' only||We hypothesized that we would observe a group by time interaction such that the PTSM group would demonstrate improvement in chronic pain acceptance - Pain Willingness - over time compared to the usual care group. This analysis was restricted to those study participants who provided data at each of the study time points ('completer' analysis).||||0.167
72566051|NCT03465436|144662842|SUPERIORITY||LS Mean|-2.42|||||TWO_SIDED|90.0|-3.42|-1.42|||Mixed Models Analysis|||4 hours postdose||-1.42|-3.42|
72566052|NCT03465436|144662842|SUPERIORITY||LS Mean|-4.61|||||TWO_SIDED|90.0|-6.17|-3.06|||Mixed Models Analysis|||6 hours postdose||-3.06|-6.17|
72566053|NCT03465436|144662842|SUPERIORITY||LS Mean|-3.82|||||TWO_SIDED|90.0|-5.38|-2.26|||Mixed Models Analysis|||8 hours postdose||-2.26|-5.38|
72566054|NCT03465436|144662842|SUPERIORITY||LS Mean|-2.65|||||TWO_SIDED|90.0|-4.33|-0.97|||Mixed Models Analysis|||12 hours postdose||-0.97|-4.33|
72566055|NCT03465436|144662842|SUPERIORITY||LS Mean|0.12|||||TWO_SIDED|90.0|-1.22|1.46|||Mixed Models Analysis|||24 hours postdose||1.46|-1.22|
72566056|NCT03465436|144662842|SUPERIORITY||LS Mean|-3.09|||||TWO_SIDED|90.0|-4.16|-2.02|||Mixed Models Analysis|||30 minutes postdose||-2.02|-4.16|
72566057|NCT03465436|144662842|SUPERIORITY||LS Mean|-5.61|||||TWO_SIDED|90.0|-6.65|-4.58|||Mixed Models Analysis|||1 hour postdose||-4.58|-6.65|
72566058|NCT03465436|144662842|SUPERIORITY||LS Mean|-5.39|||||TWO_SIDED|90.0|-6.42|-4.35|||Mixed Models Analysis|||1.5 hours postdose||-4.35|-6.42|
72566059|NCT03465436|144662842|SUPERIORITY||LS Mean|-4.64|||||TWO_SIDED|90.0|-5.55|-3.72|||Mixed Models Analysis|||2 hours postdose||-3.72|-5.55|
72566060|NCT03465436|144662842|SUPERIORITY||LS Mean|-5.82|||||TWO_SIDED|90.0|-6.77|-4.87|||Mixed Models Analysis|||2.5 hours postdose||-4.87|-6.77|
72566061|NCT03465436|144662842|SUPERIORITY||LS Mean|-4.99|||||TWO_SIDED|90.0|-6.03|-3.96|||Mixed Models Analysis|||3 hours postdose||-3.96|-6.03|
72566062|NCT03465436|144662842|SUPERIORITY||LS Mean|-3.69|||||TWO_SIDED|90.0|-4.68|-2.71|||Mixed Models Analysis|||3.5 hours postdose||-2.71|-4.68|
72566063|NCT03465436|144662842|SUPERIORITY||LS Mean|-3.19|||||TWO_SIDED|90.0|-4.21|-2.17|||Mixed Models Analysis|||4 hours postdose||-2.17|-4.21|
72566064|NCT03465436|144662842|SUPERIORITY||LS Mean|-6.29|||||TWO_SIDED|90.0|-7.83|-4.95|||Mixed Models Analysis|||6 hours postdose||-4.95|-7.83|
72566065|NCT03465436|144662842|SUPERIORITY||LS Mean|-5.37|||||TWO_SIDED|90.0|-6.73|-4.02|||Mixed Models Analysis|||8 hours postdose||-4.02|-6.73|
72566066|NCT03465436|144662842|SUPERIORITY||LS Mean|-4.71|||||TWO_SIDED|90.0|-6.25|-3.17|||Mixed Models Analysis|||12 hours postdose||-3.17|-6.25|
72566067|NCT03465436|144662842|SUPERIORITY||LS Mean|-0.55|||||TWO_SIDED|90.0|-1.74|0.63|||Mixed Models Analysis|||24 hours postdose||0.63|-1.74|
72566068|NCT03465436|144662842|SUPERIORITY||LS Mean|1.32|||||TWO_SIDED|90.0|0.32|2.33|||Mixed Models Analysis|||30 minutes postdose||2.33|0.32|
72566069|NCT03465436|144662842|SUPERIORITY||LS Mean|2.29|||||TWO_SIDED|90.0|1.19|3.4|||Mixed Models Analysis|||1 hour postdose||3.40|1.19|
72566070|NCT03465436|144662842|SUPERIORITY||LS Mean|1.3|||||TWO_SIDED|90.0|0.31|2.28|||Mixed Models Analysis|||1.5 hours postdose||2.28|0.31|
72566071|NCT03465436|144662842|SUPERIORITY||LS Mean|1.07|||||TWO_SIDED|90.0|0.17|1.97|||Mixed Models Analysis|||2 hours postdose||1.97|0.17|
72623092|NCT01385995|144776487|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-28.7||||0.002|TWO_SIDED|95.0|-46.5|-10.9|||Regression, Linear|Adjusted for period, baseline level of the outcome variable, BMI, AHI, gender and race.||Based on an intent-to-treat approach, a linear mixed effect model was used to estimate the association between therapy and measures of insulin indices, in this case oral glucose tolerance test (OGTT) insulin, between CPAP and sham-CPAP, stratified for the most severe sleep apnea group (Apnea-Hypopnea Index (AHI) \>=30) in order to assess whether the differences in the effect of CPAP on outcomes were observed according to sleep apnea severity. N=23.||-10.9|-46.5|0.002
72474614|NCT05731999|144473688|OTHER|"The hypothesis was that k = 0. If the hypothesis could be rejected (p\<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition.~Here the p-value for NYmass at 500 lux is reported."|Slope|-9.62||||0.0174|TWO_SIDED||||||Regression, Linear|||The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + m||||0.0174
72474615|NCT05731999|144473688|OTHER|"The hypothesis was that k = 0. If the hypothesis could be rejected (p\<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition.~Here the p-value for D1m at 500 lux is reported."|Slope|-9.15||||0.013|TWO_SIDED||||||Regression, Linear|||The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + m||||0.013
72474616|NCT05731999|144473688|OTHER|"The hypothesis was that k = 0. If the hypothesis could be rejected (p\<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition.~Here the p-value for NCdiff at 50 lux is reported."|Slope|-4.06|||<|0.0001|TWO_SIDED||||||Regression, Linear|||The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + m||||<0.0001
72474617|NCT05731999|144473688|OTHER|"The hypothesis was that k = 0. If the hypothesis could be rejected (p\<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition.~Here the p-value for Dbase at 50 lux is reported."|Slope|0.99||||0.0068|TWO_SIDED||||||Regression, Linear|||The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + m||||0.0068
72474618|NCT05731999|144473688|OTHER|"The hypothesis was that k = 0. If the hypothesis could be rejected (p\<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition.~Here the p-value for MCV at 50 lux is reported."|Slope|1.12||||0.0485|TWO_SIDED||||||Regression, Linear|||The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + m||||0.0485
72566072|NCT03465436|144662842|SUPERIORITY||LS Mean|0.21|||||TWO_SIDED|90.0|-0.81|1.23|||Mixed Models Analysis|||2.5 hours postdose||1.23|-0.81|
72566073|NCT03465436|144662842|SUPERIORITY||LS Mean|0.53|||||TWO_SIDED|90.0|-0.5|1.56|||Mixed Models Analysis|||3 hours postdose||1.56|-0.50|
72566074|NCT03465436|144662842|SUPERIORITY||LS Mean|1.36|||||TWO_SIDED|90.0|0.29|2.44|||Mixed Models Analysis|||3.5 hours postdose||2.44|0.29|
72566075|NCT03465436|144662842|SUPERIORITY||LS Mean|1.21|||||TWO_SIDED|90.0|0.09|2.34|||Mixed Models Analysis|||4 hours postdose||2.34|0.09|
72566076|NCT03465436|144662842|SUPERIORITY||LS Mean|-0.49|||||TWO_SIDED|90.0|-1.97|0.99|||Mixed Models Analysis|||6 hours postdose||0.99|-1.97|
72566077|NCT03465436|144662842|SUPERIORITY||LS Mean|-0.36|||||TWO_SIDED|90.0|-1.54|0.83|||Mixed Models Analysis|||8 hours postdose||0.83|-1.54|
72566078|NCT03465436|144662842|SUPERIORITY||LS Mean|0.73|||||TWO_SIDED|90.0|-0.87|2.34|||Mixed Models Analysis|||12 hours postdose||2.34|-0.87|
72566079|NCT03465436|144662842|SUPERIORITY||LS Mean|-0.12|||||TWO_SIDED|90.0|-1.29|1.04|||Mixed Models Analysis|||24 hours postdose||1.04|-1.29|
72566080|NCT01252719|144662910|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The non-inferiority hypothesis test was a one-sided hypothesis test performed at the 2.5% level of significance. If the lower limit of the two-sided 95% CI for the difference in response rates in the mITT population was greater than -10%, the NI of oritavancin to vancomycin was concluded.|Difference in Proportions|-0.4|||||TWO_SIDED|95.0|-5.5|4.7||||||||4.7|-5.5|
72566081|NCT01252719|144662911|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The non-inferiority hypothesis test was a one-sided hypothesis test performed at the 2.5% level of significance. If the lower limit of the two-sided 95% confidence interval (CI) for the difference in response rates in the mITT population was greater than -10% the non-inferiority (NI) of oritavancin to vancomycin was concluded.|Difference in Proportions|3.4|||||TWO_SIDED|95.0|-1.6|8.4||||||||8.4|-1.6|
72474619|NCT05731999|144473688|OTHER|"The hypothesis was that k = 0. If the hypothesis could be rejected (p\<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition.~Here the p-value for Ctime at 50 lux is reported."|Slope|2.08||||0.0031|TWO_SIDED||||||Regression, Linear|||The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + m||||0.0031
72474620|NCT05731999|144473688|OTHER|"The hypothesis was that k = 0. If the hypothesis could be rejected (p\<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition.~Here the p-value for MCA at 50 lux is reported."|Slope|1.18||||0.0036|TWO_SIDED||||||Regression, Linear|||The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + m||||0.0036
72474621|NCT05731999|144473688|OTHER|"The hypothesis was that k = 0. If the hypothesis could be rejected (p\<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition.~Here the p-value for RMCA at 50 lux is reported."|Slope|1.05||||0.0089|TWO_SIDED||||||Regression, Linear|||The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + m||||0.0089
72474622|NCT05731999|144473688|OTHER|"The hypothesis was that k = 0. If the hypothesis could be rejected (p\<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition.~Here the p-value for NCdiff at 500 lux is reported."|Slope|-4.04|||<|0.0001|TWO_SIDED||||||Regression, Linear|||The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + m||||<0.0001
72474623|NCT05731999|144473688|OTHER|"The hypothesis was that k = 0. If the hypothesis could be rejected (p\<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition.~Here the p-value for MM30 at 500 lux is reported."|Slope|1.62||||0.0239|TWO_SIDED||||||Regression, Linear|||The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + m||||0.0239
72474624|NCT05731999|144473688|OTHER|"The hypothesis was that k = 0. If the hypothesis could be rejected (p\<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition.~Here the p-value for Dcon at 500 lux is reported."|Slope|0.93||||0.0435|TWO_SIDED||||||Regression, Linear|||The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + m||||0.0435
72474625|NCT05731999|144473688|OTHER|"The hypothesis was that k = 0. If the hypothesis could be rejected (p\<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition.~Here the p-value for Ctime at 500 lux is reported."|Slope|1.26||||0.0126|TWO_SIDED||||||Regression, Linear|||The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + m||||0.0126
72474626|NCT05731999|144473688|OTHER|"The hypothesis was that k = 0. If the hypothesis could be rejected (p\<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition.~Here the p-value for NCdiff at 50 lux is reported."|Slope|-0.73||||0.0294|TWO_SIDED||||||Regression, Linear|||The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + m||||0.0294
72507281|NCT03151148|144546503|SUPERIORITY||Geometric mean ratio (GMR)|35.19|||<|0.001|TWO_SIDED|95.0|14.402|85.972|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator.|"TMT vs Placebo on Lesional Skin at Day 4~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||85.972|14.402|<0.001
72398347|NCT03045081|144303033|OTHER|Generalized estimating equations (GEE) were used to test this hypothesis. Main effects of group and time, and group × time interactions were evaluated. Models for the entire study sample and for only those who provided outcome data at all study time points (0, 3, 6 months) were evaluated (see Statistical Analysis 2).||||||0.176||||||Wald χ2 p-values \< 0.05 considered statistically significant for group x time interaction|Wald χ2|Intent-to-treat analysis (full sample).||We hypothesized that we would observe a group (usual care vs PTSM) by time (0, 3, 6 months) interaction, such that the PTSM group would demonstrate improved confidence in patient-provider interactions over time compared to the usual care group.||||0.176
72474627|NCT05731999|144473688|OTHER|"The hypothesis was that k = 0. If the hypothesis could be rejected (p\<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition.~Here the p-value for D1m at 50 lux is reported."|Slope|0.96||||0.0204|TWO_SIDED||||||Regression, Linear|||The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + m||||0.0204
72474628|NCT05731999|144473688|OTHER|"The hypothesis was that k = 0. If the hypothesis could be rejected (p\<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition.~Here the p-value for D2m at 50 lux is reported."|Slope|1.41||||0.0004|TWO_SIDED||||||Regression, Linear|||The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + m||||0.0004
72474629|NCT05731999|144473688|OTHER|"The hypothesis was that k = 0. If the hypothesis could be rejected (p\<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition.~Here the p-value for MCV at 50 lux is reported."|Slope|-0.95||||0.0013|TWO_SIDED||||||Regression, Linear|||The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + m||||0.0013
72507282|NCT03151148|144546503|SUPERIORITY||Geometric mean ratio (GMR)|41.64|||<|0.001|TWO_SIDED|95.0|17.043|101.739|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator.|"TMT vs Placebo on Lesional Skin at Day 7~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||101.739|17.043|<0.001
72507283|NCT03151148|144546503|SUPERIORITY||Geometric mean ratio (GMR)|3.61||||0.008|TWO_SIDED|95.0|1.395|9.33|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator.|"TMT vs Placebo on Lesional Skin at Day 8~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||9.330|1.395|0.008
72507284|NCT03151148|144546503|SUPERIORITY||Geometric mean ratio (GMR)|1.39||||0.474|TWO_SIDED|95.0|0.561|3.458|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator.|"TMT vs Placebo on Lesional Skin at Day 11~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||3.458|0.561|0.474
72507285|NCT03151148|144546503|SUPERIORITY||Geometric mean ratio (GMR)|266.87|||<|0.001|TWO_SIDED|95.0|108.86|654.231|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator.|"TMT vs Placebo on Non-lesional Skin at Day 0 (post-treatment)~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||654.231|108.860|<0.001
72507286|NCT03151148|144546503|SUPERIORITY||Geometric mean ratio (GMR)|51.07|||<|0.001|TWO_SIDED|95.0|20.907|124.768|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator.|"TMT vs Placebo on Non-lesional Skin at Day 4~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||124.768|20.907|<0.001
72623093|NCT01385995|144776488|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.5||||0.18|TWO_SIDED|95.0|-17.6|3.8|||Regression, Linear|||Based on an intent-to-treat approach, a linear mixed effect model was used to estimate the association between therapy and Homeostasis Model Assessment-Insulin Resistance (HOMA-IR), between CPAP and sham-CPAP.||3.8|-17.6|0.18
72398348|NCT03045081|144303033|OTHER|Generalized estimating equations were used to test this hypothesis.||||||0.143||||||Wald χ2 \< 0.05 considered statistically significant for group x time interaction.|Wald χ2|Study 'completers' only||We hypothesized that we would observe a group (usual care vs PTSM) by time (0, 3, 6 months) interaction, such that the PTSM group would demonstrate improved confidence in patient-provider interactions over time compared to the usual care group. This analysis was restricted to those study participants who provided data at each of the study time points ('completer' analysis).||||0.143
72398349|NCT03045081|144303034|OTHER|Generalized estimating equations (GEE) were used to test this hypothesis. Main effects of group and time, and group × time interactions were evaluated. Models for the entire study sample and for only those who provided outcome data at all study time points (0, 3, 6 months) were evaluated (see Statistical Analysis 2).|||||<|0.05||||||Wald χ2 p-values \< 0.05 considered statistically significant.|Wald χ2|Intent-to-treat analysis (full sample).||We hypothesized that we would observe a group (usual care vs PTSM) by time (0, 3, 6 months) interaction, such that the PTSM group would demonstrate improved satisfaction with pain treatment over time compared to the usual care group.||||<0.05
72398350|NCT03045081|144303034|OTHER|Generalized estimating equations (GEE) were used to test this hypothesis.|||||<|0.001||||||Wald χ2 \< 0.05 were considered statistically significant for the group x time interaction.|Wald χ2|Study 'completers' only||We hypothesized that we would observe a group (usual care vs PTSM) by time (0, 3, 6 months) interaction, such that the PTSM group would demonstrate improved satisfaction with pain treatment over time compared to the usual care group. This analysis was restricted to those study participants who provided data at each of the study time points (i.e., 'completer' analysis).||||<0.001
72398351|NCT03045081|144303036|OTHER|Generalized estimating equations (GEE) were used to test this hypothesis.Models for the entire study sample and for only those who provided outcome data at all study time points (0, 3, 6 months) were evaluated (see Statistical Analysis 2).||||||0.102||||||Wald χ2 p-values \< 0.05 considered statistically significant.|Wald χ2|Intent-to-treat analysis (full sample).||We hypothesized that we would observe a group (usual care vs PTSM) by time (0, 3, 6 months) interaction, such that the PTSM group would demonstrate greater reductions in pain intensity and interference over time compared to the usual care group.||||0.102
72474630|NCT05731999|144473688|OTHER|"The hypothesis was that k = 0. If the hypothesis could be rejected (p\<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition.~Here the p-value for MCA at 50 lux is reported."|Slope|-0.77||||0.0003|TWO_SIDED||||||Regression, Linear|||The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + m||||0.0003
72474631|NCT05731999|144473688|OTHER|"The hypothesis was that k = 0. If the hypothesis could be rejected (p\<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition.~Here the p-value for RMCA at 50 lux is reported."|Slope|-0.94|||<|0.0001|TWO_SIDED||||||Regression, Linear|||The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + m||||<0.0001
72474632|NCT05731999|144473688|OTHER|"The hypothesis was that k = 0. If the hypothesis could be rejected (p\<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition.~Here the p-value for Redness at 50 lux is reported."|Slope|0.81|||<|0.0001|TWO_SIDED||||||Regression, Linear|||The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + m||||<0.0001
72507287|NCT03151148|144546503|SUPERIORITY||Geometric mean ratio (GMR)|74.96|||<|0.001|TWO_SIDED|95.0|30.686|183.125|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator.|"TMT vs Placebo on Non-lesional Skin at Day 7~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||183.125|30.686|<0.001
72507288|NCT03151148|144546503|SUPERIORITY||Geometric mean ratio (GMR)|26.06|||<|0.001|TWO_SIDED|95.0|10.262|66.169|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator.|"TMT vs Placebo on Non-lesional Skin at Day 8~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||66.169|10.262|<0.001
72398352|NCT03045081|144303036|OTHER|Generalized estimating equations (GEE) were used to test this hypothesis.|||||<|0.05||||||Wald χ2 \< 0.05 considered statistically significant for group x time interaction|Wald χ2|Study 'completers' only||We hypothesized that we would observe a group (usual care vs PTSM) by time (0, 3, 6 months) interaction, such that the PTSM group would demonstrate greater reductions in pain intensity and interference over time compared to the usual care group. This analysis was restricted to those study participants who provided data at each time point (as treated, 'completer' analysis).||||<0.05
72398353|NCT02493608|144303147|OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
72398354|NCT02493608|144303148|OTHER|||||||0.218||||||POD 1|t-test, 2 sided|||||||0.218
72398355|NCT02493608|144303148|OTHER|||||||0.638||||||POD 2|t-test, 2 sided|||||||0.638
72398356|NCT02493608|144303149|OTHER|||||||0.113|||||||t-test, 2 sided|||||||0.113
72398357|NCT00546637|144303155|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.4|STANDARD_ERROR_OF_MEAN|0.3||0.1959||95.0|-0.9|0.2||P-value was based on an ANCOVA model with terms for country, treatment, and baseline value as covariate. No adjustment of p-value was made for multiple comparisons.|ANCOVA||Mean difference (Net) = Least squares mean|The null hypothesis was that the mean change from Baseline in 24-hour micturition-related urgency was the same at Week 12 for the two treatment groups: fesoterodine + alpha-blocker vs. placebo + alpha-blocker. It was estimated that 900 randomized subjects would have 85% power to detect a mean difference of -0.93(SD = 4.15) between the 2 treatments on the primary endpoint,mean reduction of micturition-related urgency episodes/24hr from Baseline to Week 12,assuming a 10% non-evaluability rate.||0.2|-0.9|0.1959
72474633|NCT05731999|144473688|OTHER|"The hypothesis was that k = 0. If the hypothesis could be rejected (p\<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition.~Here the p-value for NCdiff at 500 lux is reported."|Slope|-0.87||||0.0096|TWO_SIDED||||||Regression, Linear|||The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + m||||0.0096
72474634|NCT05731999|144473688|OTHER|"The hypothesis was that k = 0. If the hypothesis could be rejected (p\<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition.~Here the p-value for Redness at 500 lux is reported."|Slope|0.36||||0.0003|TWO_SIDED||||||Regression, Linear|||The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + m||||0.0003
72507289|NCT03151148|144546503|SUPERIORITY||Geometric mean ratio (GMR)|3.41||||0.007|TWO_SIDED|95.0|1.397|8.338|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator.|"TMT vs Placebo on Non-lesional Skin at Day 11~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||8.338|1.397|0.007
72507290|NCT03151148|144546504|SUPERIORITY||Geometric mean ratio (GMR)|51.1|||<|0.001|TWO_SIDED|95.0|21.692|120.379|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator.|"TMT vs Placebo on Lesional Skin at Day 0 (post-treatment)~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||120.379|21.692|<0.001
72507291|NCT03151148|144546504|SUPERIORITY||Geometric mean ratio (GMR)|12.87|||<|0.001|TWO_SIDED|95.0|5.463|30.317|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator.|"TMT vs Placebo on Lesional Skin at Day 4~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||30.317|5.463|<0.001
72566082|NCT01252719|144662912|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The non-inferiority hypothesis test was a one-sided hypothesis test performed at the 2.5% level of significance. If the lower limit of the two-sided 95% CI for the difference in response rates in the mITT population was greater than -10% the NI of oritavancin to vancomycin was concluded.|Difference in Proportions|4.1|||||TWO_SIDED|95.0|-0.5|8.6||||||||8.6|-0.5|
72474635|NCT05731999|144473688|OTHER|"The hypothesis was that k = 0. If the hypothesis could be rejected (p\<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition.~Here the p-value for MM10 at 50 lux is reported."|Slope|2.13||||0.0063|TWO_SIDED||||||Regression, Linear|||The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + m||||0.0063
72474636|NCT05731999|144473688|OTHER|"The hypothesis was that k = 0. If the hypothesis could be rejected (p\<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition.~Here the p-value for MM30 at 50 lux is reported."|Slope|2.3||||0.0018|TWO_SIDED||||||Regression, Linear|||The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + m||||0.0018
72398358|NCT00546637|144303156|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.5|STANDARD_ERROR_OF_MEAN|0.2||0.0621||95.0|-1.0|0.0||P-value was based on an ANCOVA model with terms for country, treatment, and baseline value as covariate. No adjustment of p-value was made for multiple comparisons.|ANCOVA||Mean difference (net) = Least squares mean|||0.0|-1.0|0.0621
72474637|NCT05731999|144473688|OTHER|"The hypothesis was that k = 0. If the hypothesis could be rejected (p\<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition.~Here the p-value for Pa at 50 lux is reported."|Slope|3.22||||0.0134|TWO_SIDED||||||Regression, Linear|||The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + m||||0.0134
72474638|NCT05731999|144473688|OTHER|"The hypothesis was that k = 0. If the hypothesis could be rejected (p\<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition.~Here the p-value for Dbase at 50 lux is reported."|Slope|-1.48|||<|0.0001|TWO_SIDED||||||Regression, Linear|||The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + m||||<0.0001
72474639|NCT05731999|144473688|OTHER|"The hypothesis was that k = 0. If the hypothesis could be rejected (p\<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition.~Here the p-value for MCV at 50 lux is reported."|Slope|-2.48|||<|0.0001|TWO_SIDED||||||Regression, Linear|||The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + m||||<0.0001
72507292|NCT03151148|144546504|SUPERIORITY||Geometric mean ratio (GMR)|11.46|||<|0.001|TWO_SIDED|95.0|4.863|26.986|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator.|"TMT vs Placebo on Lesional Skin at Day 7~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||26.986|4.863|<0.001
72542454|NCT00106028|144614673|SUPERIORITY_OR_OTHER||Mean Difference (Net)|6.04||||1789|TWO_SIDED|95.0|-2.807|14.887|||ANCOVA|LS means and p-value are from ANCOVA model adjusted by baseline and fixed effects for age group, treatment and pooled center for post-baseline.||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.||14.887|-2.807|01789
72474640|NCT05731999|144473688|OTHER|"The hypothesis was that k = 0. If the hypothesis could be rejected (p\<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition.~Here the p-value for Dcon at 50 lux is reported."|Slope|-1.264|||<|0.0001|TWO_SIDED||||||Regression, Linear|||The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + m||||<0.0001
72474641|NCT05731999|144473688|OTHER|"The hypothesis was that k = 0. If the hypothesis could be rejected (p\<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition.~Here the p-value for Dend at 50 lux is reported."|Slope|-1.47|||<|0.0001|TWO_SIDED||||||Regression, Linear|||The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + m||||<0.0001
72474642|NCT05731999|144473688|OTHER|"The hypothesis was that k = 0. If the hypothesis could be rejected (p\<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition.~Here the p-value for MCA at 50 lux is reported."|Slope|-1.64|||<|0.0001|TWO_SIDED||||||Regression, Linear|||The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + m||||<0.0001
72474643|NCT05731999|144473688|OTHER|"The hypothesis was that k = 0. If the hypothesis could be rejected (p\<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition.~Here the p-value for RMCA at 50 lux is reported."|Slope|-1.63|||<|0.0001|TWO_SIDED||||||Regression, Linear|||The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + m||||<0.0001
72398359|NCT00546637|144303158|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.4|STANDARD_ERROR_OF_MEAN|0.2||0.0056||95.0|-0.8|-0.1||P-value was based on ANCOVA model with terms for country, treatment, and baseline value as a covariate. No adjustment of p-value was made for multiple comparisons.|ANCOVA||Mean difference (net) = Least squares mean|Week 4||-0.1|-0.8|0.0056
72398360|NCT00546637|144303158|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.4|STANDARD_ERROR_OF_MEAN|0.2||0.009||95.0|-0.7|-0.1||P-value was based on ANCOVA model with terms for country, treatment, and baseline value as covariate. No adjustment of p-value was made for multiple comparisons.|ANCOVA||Mean difference (net) = Least squares mean|Week 12||-0.1|-0.7|0.0090
72474644|NCT05731999|144473688|OTHER|"The hypothesis was that k = 0. If the hypothesis could be rejected (p\<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition.~Here the p-value for PESC at 50 lux is reported."|Slope|1.43||||0.0313|TWO_SIDED||||||Regression, Linear|||The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + m||||0.0313
72398361|NCT00546637|144303159|SUPERIORITY_OR_OTHER|||||||0.0012||95.0||||P-value was based on a ranked ANCOVA model with terms for country, treatment, and ranked baseline value as a covariate. No adjustment of p-value was made for multiple comparisons.|Ranked ANCOVA|Treatment comparisons were performed only if the corresponding numerical change from Baseline at the same visit was statistically significant.||Week 4||||0.0012
72474645|NCT05731999|144473688|OTHER|"The hypothesis was that k = 0. If the hypothesis could be rejected (p\<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition.~Here the p-value for MM5 at 500 lux is reported."|Slope|1.92||||0.0481|TWO_SIDED||||||Regression, Linear|||The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + m||||0.0481
72474646|NCT05731999|144473688|OTHER|"The hypothesis was that k = 0. If the hypothesis could be rejected (p\<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition.~Here the p-value for MM10 at 500 lux is reported."|Slope|2.57||||0.0171|TWO_SIDED||||||Regression, Linear|||The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + m||||0.0171
72474647|NCT05731999|144473688|OTHER|"The hypothesis was that k = 0. If the hypothesis could be rejected (p\<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition.~Here the p-value for MM30 at 500 lux is reported."|Slope|3.84||||0.0007|TWO_SIDED||||||Regression, Linear|||The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + m||||0.0007
72474648|NCT05731999|144473688|OTHER|"The hypothesis was that k = 0. If the hypothesis could be rejected (p\<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition.~Here the p-value for dbase at 500 lux is reported."|Slope|-2.15|||<|0.0001|TWO_SIDED||||||Regression, Linear|||The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + m||||<0.0001
72474649|NCT05731999|144473688|OTHER|"The hypothesis was that k = 0. If the hypothesis could be rejected (p\<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition.~Here the p-value for MCV at 500 lux is reported."|Slope|-2.2|||<|0.0001|TWO_SIDED||||||Regression, Linear|||The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + m||||<0.0001
72398362|NCT00546637|144303159|SUPERIORITY_OR_OTHER|||||||0.0027||95.0||||P-value was based on a ranked ANCOVA model with terms for country, treatment, and ranked baseline value as a covariate. No adjustment of p-value was made for multiple comparisons.|Ranked ANCOVA|Treatment comparisons were performed only if the corresponding numerical change from Baseline at the same visit was statistically significant.||Week 12||||0.0027
72398363|NCT00546637|144303160|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1|STANDARD_ERROR_OF_MEAN|0.1||0.1112||95.0|-0.2|0.0||P-value was based on ANCOVA model with terms for country, treatment, and baseline value as covariate. No adjustment of p-value was made for multiple comparisons.|ANCOVA||Mean difference (net) = Least squares mean|Week 4||0.0|-0.2|0.1112
72398364|NCT00546637|144303160|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1|STANDARD_ERROR_OF_MEAN|0.1||0.0855||95.0|-0.3|0.0||P-value was based on ANCOVA model with terms for country, treatment, and baseline value as covariate. No adjustment of p-value was made for multiple comparisons.|ANCOVA||Mean difference (net) = Least squares mean|Week 12||0.0|-0.3|0.0855
72398365|NCT00546637|144303162|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0||||0.3847||95.0||||P-value was based on Van Elteren's Test adjusted by baseline quartiles. No adjustment of p-value was made for multiple comparisons.|Van Elteren's Test||Median difference was estimated using Hodges-Lehmann estimate of the location shift between the two groups.|Week 4||||0.3847
72398366|NCT00546637|144303162|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.0||||0.4449||95.0||||P-value was based on Van Elteren's Test adjusted by baseline quartiles. No adjustment of p-value was made for multiple comparisons.|Van Elteren's Test||Median difference was estimated using Hodges-Lehmann estimate of the location shift between the two groups.|Week 12||||0.4449
72398367|NCT00546637|144303164|SUPERIORITY_OR_OTHER||Median Difference (Net)|-0.33||||0.0062||95.0||||P-value was based on Van Elteren's Test adjusted by baseline quartiles. No adjustment of p-value was made for multiple comparisons.|Van Elteren's Test||Median difference was based on Hodges-Lehmann estimate of the location shift between the two groups.|Week 4||||0.0062
72398368|NCT00546637|144303164|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.0||||0.0825||95.0||||P-value was based on Van Elteren's Test adjusted by baseline quartiles. No adjustment of p-value was made for multiple comparisons.|Van Elteren's Test||Median difference was based on Hodges-Lehmann estimate of the location shift between the two groups.|Week 12||||0.0825
72474650|NCT05731999|144473688|OTHER|"The hypothesis was that k = 0. If the hypothesis could be rejected (p\<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition.~Here the p-value for Dcon at 500 lux is reported."|Slope|-2.44|||<|0.0001|TWO_SIDED||||||Regression, Linear|||The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + m||||<0.0001
72474651|NCT05731999|144473688|OTHER|"The hypothesis was that k = 0. If the hypothesis could be rejected (p\<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition.~Here the p-value for Dend at 500 lux is reported."|Slope|-3.01|||<|0.0001|TWO_SIDED||||||Regression, Linear|||The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + m||||<0.0001
72474652|NCT05731999|144473688|OTHER|"The hypothesis was that k = 0. If the hypothesis could be rejected (p\<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition.~Here the p-value for MCA at 500 lux is reported."|Slope|-1.82|||<|0.0001|TWO_SIDED||||||Regression, Linear|||The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + m||||<0.0001
72507293|NCT03151148|144546504|SUPERIORITY||Geometric mean ratio (GMR)|2.42||||0.058|TWO_SIDED|95.0|0.971|6.024|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator.|"TMT vs Placebo on Lesional Skin at Day 8~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||6.024|0.971|0.058
72398369|NCT00546637|144303165|SUPERIORITY_OR_OTHER|||||||0.0025||95.0||||P-value for median was based on a ranked ANCOVA model with terms for country, treatment, and ranked baseline value as a covariate. No adjustment of p-value was made for multiple comparisons.|Ranked ANCOVA|Treatment comparisons were performed only if the corresponding numerical change from Baseline at the same visit was statistically significant.||Week 4||||0.0025
72576825|NCT00261443|144680657|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.22||||0.073|TWO_SIDED|95.0|-0.46|0.02||Baseline: ANOVA model, controlling for treatment, mood stabilizer, and index mood episode. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 28 Comparison||0.02|-0.46|0.073
72398370|NCT00546637|144303166|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1|STANDARD_ERROR_OF_MEAN|0.1||0.1748||95.0|-0.3|0.0||P-value was based on ANCOVA model with terms for country, treatment, and baseline value as covariate. No adjustment of p-value was made for multiple comparisons.|ANCOVA||Mean difference (net) = Least squares mean|Week 4||0.0|-0.3|0.1748
72398371|NCT00546637|144303166|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|0.1||0.6572||95.0|-0.1|0.2||P-value was based on ANCOVA model with terms for country, treatment, and baseline value as covariate. No adjustment of p-value was made for multiple comparisons.|ANCOVA||Mean difference (net) = Least squares mean|Week 12||0.2|-0.1|0.6572
72398372|NCT00546637|144303168|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.7|STANDARD_ERROR_OF_MEAN|0.6||0.0051||95.0|-2.9|-0.5||P-value was based on ANCOVA model with terms for country, treatment, and baseline value as covariate. No adjustment of p-value was made for multiple comparisons.|ANCOVA||Mean difference (net) = Least squares mean|Week 4||-0.5|-2.9|0.0051
72398373|NCT00546637|144303168|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.0|STANDARD_ERROR_OF_MEAN|0.7||0.1231||95.0|-2.3|0.3||P-value was based on ANCOVA model with terms for country, treatment, and baseline value as covariate. No adjustment of p-value was made for multiple comparisons.|ANCOVA||Mean difference (net) = Least squares mean|Week 12||0.3|-2.3|0.1231
72398374|NCT00546637|144303169|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.3|STANDARD_ERROR_OF_MEAN|0.4||0.3579||95.0|-1.0|0.4||P-value was based on an ANCOVA model with terms for country, treatment, and baseline value as covariate. No adjustment of p-value was made for multiple comparisons.|ANCOVA||Mean difference (net) = Least squares mean|Week 4||0.4|-1.0|0.3579
72398375|NCT00546637|144303169|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|0.4||0.9274||95.0|-0.8|0.7||P-value was based on an ANCOVA model with terms for country, treatment, and baseline value as covariate. No adjustment of p-value was made for multiple comparisons.|ANCOVA||Mean difference (net) = Least squares mean|Week 12||0.7|-0.8|0.9274
72398376|NCT00546637|144303170|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.4|STANDARD_ERROR_OF_MEAN|0.2||0.0223||95.0|-0.7|-0.1||P-value was based on ANCOVA model with terms for country, treatment, and baseline value as a covariate. No adjustment of p-value was made for multiple comparisons.|ANCOVA||Mean difference (net) = Least squares mean|Week 4||-0.1|-0.7|0.0223
72398377|NCT00546637|144303170|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.3|STANDARD_ERROR_OF_MEAN|0.2||0.1744||95.0|-0.6|0.1||P-value was based on ANCOVA model with terms for country, treatment, and baseline value as a covariate. No adjustment of p-value was made for multiple comparisons.|ANCOVA||Mean difference (net) = Least squares mean|Week 12||0.1|-0.6|0.1744
72398378|NCT00546637|144303171|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.1|STANDARD_ERROR_OF_MEAN|0.2||0.7564||95.0|-0.4|0.5||P-value was based on ANCOVA model with terms for country, treatment, and baseline value as a covariate. No adjustment of p-value was made for multiple comparisons.|ANCOVA||Mean difference (net) = Least squares mean|Week 4||0.5|-0.4|0.7564
72474653|NCT05731999|144473688|OTHER|"The hypothesis was that k = 0. If the hypothesis could be rejected (p\<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition.~Here the p-value for RMCA at 500 lux is reported."|Slope|-1.83|||<|0.0001|TWO_SIDED||||||Regression, Linear|||The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + m||||<0.0001
72474654|NCT05731999|144473690|OTHER||probability|0.000244|||<|0.05|TWO_SIDED||||||Regression, Logistic|||The null hypothesis is that the logistic regression classifier is unable to correctly classify subjects into sober or under the influence of D1-D4. The smallest odds ratio from the group false positives and false negative is reported.||||<0.05
72474655|NCT05731999|144473690|OTHER||probability|0.00586|||<|0.05|TWO_SIDED||||||Regression, Logistic|||The null hypothesis is that the logistic regression classifier is unable to correctly classify subjects into sober or under the influence of D1-D4. The greatest p value from the group false positives and false negative is reported.||||<0.05
72474656|NCT05731999|144473690|OTHER||probability|0.0193|||<|0.05|TWO_SIDED||||||Regression, Logistic|||The null hypothesis is that the logistic regression classifier is unable to correctly classify subjects into sober or under the influence of D1-D4. The greatest p value from the group false positives and false negative is reported.||||<0.05
72474657|NCT05731999|144473690|OTHER||probability|0.000488|||<|0.05|TWO_SIDED||||||Regression, Logistic|||The null hypothesis is that the logistic regression classifier is unable to correctly classify subjects into sober or under the influence of D1-D4. The greatest p value from the group false positives and false negative is reported.||||<0.05
72474658|NCT05731999|144473690|OTHER||probability|0.1133|||<|0.05|TWO_SIDED||||||Regression, Logistic|||The null hypothesis is that the logistic regression classifier is unable to correctly classify subjects into sober or under the influence of D1-D4. The greatest p value from the group false positives and false negative is reported.||||<0.05
72542455|NCT00106028|144614674|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.28||||0.9646|TWO_SIDED|95.0|-12.196|12.755|||ANCOVA|LS means and p-value are from ANCOVA model adjusted by baseline and fixed effects for age group, treatment and pooled center for post-baseline.||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.||12.755|-12.196|0.9646
72398379|NCT00546637|144303171|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.2|STANDARD_ERROR_OF_MEAN|0.2||0.401||95.0|-0.3|0.7||P-value was based on ANCOVA model with terms for country, treatment, and baseline value as a covariate. No adjustment of p-value was made for multiple comparisons.|ANCOVA||Mean difference (net) = Least squares mean|Week 12||0.7|-0.3|0.4010
72398380|NCT00546637|144303172|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1|STANDARD_ERROR_OF_MEAN|0.1||0.1472||95.0|-0.2|0.0||P-value was based on ANCOVA model with terms for country, treatment, and baseline value as covariate. No adjustment of p-value was made for multiple comparisons.|ANCOVA||Mean difference (net) = Least squares mean|Week 4||0.0|-0.2|0.1472
72398381|NCT00546637|144303172|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|0.1||0.5839||95.0|-0.2|0.1||P-value was based on ANCOVA model with terms for country, treatment, and baseline value as covariate. No adjustment of p-value was made for multiple comparisons.|ANCOVA||Mean difference (net) = Least squares mean|Week 12||0.1|-0.2|0.5839
72398382|NCT00546637|144303173|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|0.1||0.6621||95.0|-0.1|0.2||P-value was based on ANCOVA model with terms for country, treatment, and baseline value as covariate. No adjustment of p-value was made for multiple comparisons.|ANCOVA||Mean difference (net) = Least squares mean|Week 4 Q1||0.2|-0.1|0.6621
72398383|NCT00546637|144303173|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.3|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001||95.0|-0.5|-0.2||P-value was based on ANCOVA model with terms for country, treatment, and baseline value as covariate. No adjustment of p-value was made for multiple comparisons.|ANCOVA||Mean difference (net) = Least squares mean|Week 4 Q2||-0.2|-0.5|<.0001
72398384|NCT00546637|144303173|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.1|STANDARD_ERROR_OF_MEAN|0.1||0.3242||95.0|-0.1|0.2||P-value was based on ANCOVA model with terms for country, treatment, and baseline value as covariate. No adjustment of p-value was made for multiple comparisons.|ANCOVA||Mean difference (net) = Least squares mean|Week 4 Q3||0.2|-0.1|0.3242
72474659|NCT05731999|144473690|OTHER||probability|0.0107|||<|0.05|TWO_SIDED||||||Regression, Logistic|||||||<0.05
72474660|NCT01167452|144473741|SUPERIORITY_OR_OTHER||Slope|-0.74|STANDARD_DEVIATION|0.19||0.0004|TWO_SIDED||||||Regression, Linear|Multivariate adaptive regression spline (MARS) analysis||We conducted a linear regression analysis of the log transformed elimination rate constant vs. the log transformed weight for each participant.||||0.0004
72398385|NCT00546637|144303173|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1|STANDARD_ERROR_OF_MEAN|0.1||0.1604||95.0|-0.3|0.0||P-value was based on ANCOVA model with terms for country, treatment, and baseline value as covariate. No adjustment of p-value was made for multiple comparisons.|ANCOVA||Mean difference (net) = Least squares mean|Week 4 Q4||0.0|-0.3|0.1604
72474661|NCT01167452|144473741|SUPERIORITY_OR_OTHER||Slope|-0.56|STANDARD_DEVIATION|0.2|<|0.0001|TWO_SIDED||||||Regression, Linear|Multiple Adaptive Regression Spline (MARS)||We conducted a linear regression analysis of the log transformed elimination rate constant vs. the log transformed body mass index for each participant.||||<0.0001
72398386|NCT00546637|144303173|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1|STANDARD_ERROR_OF_MEAN|0.1||0.4102||95.0|-0.2|0.1||P-value was based on ANCOVA model with terms for country, treatment, and baseline value as covariate. No adjustment of p-value was made for multiple comparisons.|ANCOVA||Mean difference (net) = Least squares mean|Week 4 Q5||0.1|-0.2|0.4102
72398387|NCT00546637|144303173|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.1|STANDARD_ERROR_OF_MEAN|0.1||0.3079||95.0|-0.1|0.2||P-value was based on ANCOVA model with terms for country, treatment, and baseline value as covariate. No adjustment of p-value was made for multiple comparisons.|ANCOVA||Mean difference (net) = Least squares mean|Week 4 Q6||0.2|-0.1|0.3079
72474662|NCT03101462|144473798|OTHER|ANOVA||||||0.89|||||||t-test, 2 sided|||A/H1N1 Day 0||||0.89
72474663|NCT03101462|144473798|OTHER|||||||0.00082||||||This is the calculated p-value.|t-test, 2 sided|||A/H1N1 Day 7||||0.00082
72474664|NCT03101462|144473798|OTHER|||||||7.6e-05||||||This is the calculated p-value|t-test, 2 sided|||A/H1N1 Day 45||||0.000076
72474665|NCT03101462|144473798|OTHER|||||||0.63|||||||t-test, 2 sided|||A/H3N2 Day 0||||0.63
72474666|NCT03101462|144473798|OTHER|||||||0.0186||||||This is the calculated p-value|t-test, 2 sided|||A/H3N2 Day 7||||0.0186
72566083|NCT03135899|144662924|OTHER||Mean Difference (Final Values)|0.059|STANDARD_ERROR_OF_MEAN|0.064|||TWO_SIDED|90.0|-0.048|0.165|||Mixed Models Analysis||BI 443651 100 μg is compared to placebo.|The mixed effects model included 'treatment' and 'period' as fixed effects, 'patient' as a random effect, and 'period baseline' as well as 'patient baseline' as covariates. No hypothesis was tested. The patient baseline was obtained by calculating the mean of the period baselines for each patient. Covariance structure variance component (VC) was used for random subject effect.||0.165|-0.048|
72398388|NCT00546637|144303173|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.1|STANDARD_ERROR_OF_MEAN|0.1||0.4066|TWO_SIDED|95.0|-0.1|0.2||P-value was based on ANCOVA model with terms for country, treatment, and baseline value as covariate. No adjustment of p-value was made for multiple comparisons.|ANCOVA||Mean difference (net) = Least squares mean|Week 4 Q7||0.2|-0.1|0.4066
72398389|NCT00546637|144303174|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.1|STANDARD_ERROR_OF_MEAN|0.1||0.1595||95.0|0.0|0.3||P-value was based on ANCOVA model with terms for country, treatment, and baseline value as covariate. No adjustment of p-value was made for multiple comparisons.|ANCOVA||Mean difference (net) = Least squares mean|Week 12 Q1||0.3|-0.0|0.1595
72398390|NCT00546637|144303174|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.2|STANDARD_ERROR_OF_MEAN|0.1||0.0614||95.0|-0.3|0.0||P-value was based on ANCOVA model with terms for country, treatment, and baseline value as covariate. No adjustment of p-value was made for multiple comparisons.|ANCOVA||Mean difference (net) = Least squares mean|Week 12 Q2||0.0|-0.3|0.0614
72398391|NCT00546637|144303174|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.1|STANDARD_ERROR_OF_MEAN|0.1||0.2032||95.0|-0.1|0.3||P-value was based on ANCOVA model with terms for country, treatment, and baseline value as covariate. No adjustment of p-value was made for multiple comparisons.|ANCOVA||Mean difference (net) = Least squares mean|Week 12 Q3||0.3|-0.1|0.2032
72398392|NCT00546637|144303174|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.2|STANDARD_ERROR_OF_MEAN|0.1||0.0631||95.0|-0.3|0.0||P-value was based on ANCOVA model with terms for country, treatment, and baseline value as covariate. No adjustment of p-value was made for multiple comparisons.|ANCOVA||Mean difference (net) = Least squares mean|Week 12 Q4||0.0|-0.3|0.0631
72398393|NCT00546637|144303174|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|0.1||0.9706||95.0|-0.2|0.2||P-value was based on ANCOVA model with terms for country, treatment, and baseline value as covariate. No adjustment of p-value was made for multiple comparisons.|ANCOVA||Mean difference (net) = Least squares mean|Week 12 Q5||0.2|-0.2|0.9706
72398394|NCT00546637|144303174|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|0.1||0.8058||95.0|-0.1|0.2||P-value was based on ANCOVA model with terms for country, treatment, and baseline value as covariate. No adjustment of p-value was made for multiple comparisons.|ANCOVA||Mean difference (net) = Least squares mean|Week 12 Q6||0.2|-0.1|0.8058
72474667|NCT03101462|144473798|OTHER|||||||0.0052||||||This is the calculated p-value|t-test, 2 sided|||A/H3N2 Day 45||||0.0052
72474668|NCT03101462|144473798|OTHER|||||||0.25|||||||t-test, 2 sided|||Influenza B Day 0||||0.25
72474669|NCT03101462|144473798|OTHER|||||||0.061|||||||t-test, 2 sided|||Influenza B Day 7||||0.061
72474670|NCT03101462|144473798|OTHER|||||||0.0025|||||||t-test, 2 sided|||Influenza B Day 45||||0.0025
72474671|NCT03101462|144473799|OTHER|||||||0.24|||||||Wilcoxon (Mann-Whitney)|||Peptide Pool 1 and 2, Day 0 and Day 7||||0.24
72474672|NCT03101462|144473799|OTHER|||||||0.76|||||||Wilcoxon (Mann-Whitney)|||Peptide Pool 1 and 2, Day 0 and Day 45||||0.76
72474673|NCT03101462|144473799|OTHER|||||||0.06|||||||Wilcoxon (Mann-Whitney)|||Live H3N2, Day 0 and Day 7||||0.06
72474674|NCT03101462|144473799|OTHER|||||||0.56|||||||Wilcoxon (Mann-Whitney)|||Live H3N2, Day 0 and Day 45||||0.56
72474675|NCT03101462|144473799|OTHER|||||||0.04|||||||Wilcoxon (Mann-Whitney)|||Flumist, Day 0 and Day 7||||0.04
72474676|NCT03101462|144473799|OTHER|||||||0.16|||||||Wilcoxon (Mann-Whitney)|||Flumist, Day 0 and Day 45||||0.16
72474677|NCT03101462|144473799|OTHER|||||||0.02|||||||Wilcoxon (Mann-Whitney)|||Peptide Pool 1 and 2, Day 0 and Day 7||||0.02
72474678|NCT03101462|144473799|OTHER|||||||0.94|||||||Wilcoxon (Mann-Whitney)|||Peptide Pool 1 and 2, Day 0 and Day 45||||0.94
72474679|NCT03101462|144473799|OTHER|||||||0.002|||||||Wilcoxon (Mann-Whitney)|||Live H3N2, Day 0 and Day 7||||0.002
72474680|NCT03101462|144473799|OTHER|||||||0.16|||||||Wilcoxon (Mann-Whitney)|||Live H3N2, Day 0 and Day 45||||0.16
72474681|NCT03101462|144473799|OTHER|||||||0.02|||||||Wilcoxon (Mann-Whitney)|||Flumist, Day 0 and Day 7||||0.02
72474682|NCT03101462|144473799|OTHER|||||||0.98|||||||Wilcoxon (Mann-Whitney)|||Flumist, Day 0 and Day 45||||0.98
72474683|NCT03101462|144473800|OTHER|||||||0.04|||||||Wilcoxon (Mann-Whitney)|||Peptide Pool 1 CD4+/CFSE(low)/IFN-gamma+, Day 0 and Day 7||||0.04
72398395|NCT00546637|144303174|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.1|STANDARD_ERROR_OF_MEAN|0.1||0.3302|TWO_SIDED|95.0|-0.1|0.2||P-value was based on ANCOVA model with terms for country, treatment, and baseline value as covariate. No adjustment of p-value was made for multiple comparisons.|ANCOVA||Mean difference (net) = Least squares mean|Week 12 Q7||0.2|-0.1|0.3302
72398396|NCT00546637|144303175|SUPERIORITY_OR_OTHER|||||||0.1136||95.0||||P-value was obtained from a Cochran-Mantel-Haenszel test with modified ridit scoring, stratified by center. No adjustment of p-value was made for multiple comparisons.|Cochran-Mantel-Haenszel|||||||0.1136
72474684|NCT03101462|144473800|OTHER|||||||0.02|||||||Wilcoxon (Mann-Whitney)|||Peptide Pool 1 CD4+/CFSE(low)/IFN-gamma+, Day 0 and Day 45||||0.02
72474685|NCT03101462|144473800|OTHER|||||||0.95|||||||Wilcoxon (Mann-Whitney)|||Peptide Pool 2 CD4+/CFSE(low)/IFN-gamma+, Day 0 and Day 7||||0.95
72474686|NCT03101462|144473800|OTHER|||||||0.17|||||||Wilcoxon (Mann-Whitney)|||Peptide Pool 2 CD4+/CFSE(low)/IFN-gamma+, Day 0 and Day 45||||0.17
72474687|NCT03101462|144473800|OTHER|||||||0.06|||||||Wilcoxon (Mann-Whitney)|||Peptide Pool 1 and Peptide Pool 2 CD4+/CFSE(low)/IFN-gamma+, Day 0 and Day 7||||0.06
72474688|NCT03101462|144473800|OTHER|||||||0.14|||||||Wilcoxon (Mann-Whitney)|||Peptide Pool 1 and Peptide Pool 2 CD4+/CFSE(low)/IFN-gamma+, Day 0 and Day 45||||0.14
72474689|NCT03101462|144473800|OTHER|||||||0.02|||||||Wilcoxon (Mann-Whitney)|||Live H3N2 CD4+/CFSE(low)/IFN-gamma+, Day 0 and Day 7||||0.02
72474690|NCT03101462|144473800|OTHER|||||||0.09|||||||Wilcoxon (Mann-Whitney)|||Live H3N2 CD4+/CFSE(low)/IFN-gamma+, Day 0 and Day 45||||0.09
72474691|NCT03101462|144473800|OTHER|||||||0.01|||||||Wilcoxon (Mann-Whitney)|||Flumist CD4+/CFSE(low)/IFN-gamma+, Day 0 and Day 7||||0.01
72474692|NCT03101462|144473800|OTHER|||||||0.08|||||||Wilcoxon (Mann-Whitney)|||Flumist CD4+/CFSE(low)/IFN-gamma+, Day 0 and Day 45||||0.08
72474693|NCT03101462|144473800|OTHER|||||||0.16|||||||Wilcoxon (Mann-Whitney)|||Peptide Pool 1 CD4+/CFSE(low)/IFN-gamma+, Day 0 and Day 7||||0.16
72474694|NCT03101462|144473800|OTHER|||||||0.76|||||||Wilcoxon (Mann-Whitney)|||Peptide Pool 1 CD4+/CFSE(low)/IFN-gamma+, Day 0 and Day 45||||0.76
72398397|NCT00546637|144303176|SUPERIORITY_OR_OTHER|||||||0.5775||95.0||||P-value was obtained from a Cochran-Mantel-Haenszel test with modified ridit scoring, stratified by center. No adjustment of p-value was made for multiple comparisons.|Cochran-Mantel-Haenszel|||||||0.5775
72398398|NCT00546637|144303177|SUPERIORITY_OR_OTHER|||||||0.7433||95.0||||P-value was obtained from a Cochran-Mantel-Haenszel test with modified ridit scoring, stratified by center. No adjustment of p-value was made for multiple comparisons.|Cochran-Mantel-Haenszel|||||||0.7433
72398399|NCT00546637|144303178|SUPERIORITY_OR_OTHER|||||||0.9402||95.0||||P-value was obtained from a Cochran-Mantel-Haenszel test with modified ridit scoring, stratified by center. No adjustment of p-value was made for multiple comparisons.|Cochran-Mantel-Haenszel|||||||0.9402
72474695|NCT03101462|144473800|OTHER|||||||0.84|||||||Wilcoxon (Mann-Whitney)|||Peptide Pool 2 CD4+/CFSE(low)/IFN-gamma+, Day 0 and Day 7||||0.84
72474696|NCT03101462|144473800|OTHER|||||||0.04|||||||Wilcoxon (Mann-Whitney)|||Peptide Pool 2 CD4+/CFSE(low)/IFN-gamma+, Day 0 and Day 45||||0.04
72474697|NCT03101462|144473800|OTHER|||||||0.07|||||||Wilcoxon (Mann-Whitney)|||Peptide Pool 1 and Peptide Pool 2 CD4+/CFSE(low)/IFN-gamma+, Day 0 and Day 7||||0.07
72474698|NCT03101462|144473800|OTHER|||||||0.27|||||||Wilcoxon (Mann-Whitney)|||Peptide Pool 1 and Peptide Pool 2 CD4+/CFSE(low)/IFN-gamma+, Day 0 and Day 45||||0.27
72474699|NCT03101462|144473800|OTHER|||||||0.11|||||||Wilcoxon (Mann-Whitney)|||Live H3N2 CD4+/CFSE(low)/IFN-gamma+, Day 0 and Day 7||||0.11
72474700|NCT03101462|144473800|OTHER|||||||0.46|||||||Wilcoxon (Mann-Whitney)|||Live H3N2 CD4+/CFSE(low)/IFN-gamma+, Day 0 and Day 45||||0.46
72474701|NCT03101462|144473800|OTHER|||||||0.006|||||||Wilcoxon (Mann-Whitney)|||Flumist CD4+/CFSE(low)/IFN-gamma+, Day 0 and Day 7||||0.006
72474702|NCT03101462|144473800|OTHER|||||||0.41|||||||Wilcoxon (Mann-Whitney)|||Flumist CD4+/CFSE(low)/IFN-gamma+, Day 0 and Day 45||||0.41
72474703|NCT03101462|144473801|OTHER|||||||0.72|||||||Wilcoxon (Mann-Whitney)|||Influenza A/H1N1 HA, Day 0 and Day 45||||0.72
72474704|NCT03101462|144473801|OTHER|||||||0.06|||||||Wilcoxon (Mann-Whitney)|||Influenza A/H3N2 HA, Day 0 and 45||||0.06
72474705|NCT03101462|144473801|OTHER|||||||0.75|||||||Wilcoxon (Mann-Whitney)|||Influenza B HA, Day 0 and Day 45||||0.75
72474706|NCT03101462|144473801|OTHER|||||||0.05|||||||Wilcoxon (Mann-Whitney)|||Influenza A/H1N1 HA, Day 0 and Day 45||||0.05
72474707|NCT03101462|144473801|OTHER|||||||0.0004|||||||Wilcoxon (Mann-Whitney)|||Influenza A/H3N2 HA, Day 0 and Day 45||||0.0004
72474708|NCT03101462|144473801|OTHER|||||||0.02|||||||Wilcoxon (Mann-Whitney)|||Influenza B HA, Day 0 and Day 45||||0.02
72474709|NCT03101462|144473802|OTHER|||||||0.02|||||||Fisher Exact|||Fold increase IgA anti-H1N1 HA, Day 7||||0.02
72474710|NCT03101462|144473802|OTHER|||||||0.67|||||||Fisher Exact|||Fold increase IgA anti-H3N2, Day 7||||0.67
72474711|NCT03101462|144473802|OTHER|||||||0.3|||||||Fisher Exact|||Fold increase IgA anti-influenza B HA, Day 7||||0.30
72474712|NCT01696955|144473803|SUPERIORITY|||||||0.99|||||||Fisher Exact|||||||0.99
72474713|NCT01696955|144473806|SUPERIORITY|||||||0.47|||||||t-test, 2 sided|||||||0.47
72474714|NCT01696955|144473807|SUPERIORITY|||||||0.99|||||||Log Rank|||||||0.99
72474715|NCT01696955|144473808|SUPERIORITY|||||||0.58|||||||Log Rank|||||||0.58
72474716|NCT00573859|144473827|SUPERIORITY_OR_OTHER||||||<|0.05|ONE_SIDED|95.0|||||ANOVA|||A 2 (ADHD medication versus Placebo) repeated measure ANOVA||||<0.05
72474717|NCT00573859|144473828|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||ANOVA|||Four-way repeated measure ANOVA||||<0.05
72474718|NCT00573859|144473829|SUPERIORITY_OR_OTHER||||||<|0.05|ONE_SIDED|95.0|||||Friedman's two analysis of ranks|||Friedman's two-way analysis of variance by ranks.||||<0.05
72474719|NCT02001064|144473891|SUPERIORITY||Odds Ratio (OR)|2.3||||0.32|TWO_SIDED||||||t-test, 1 sided|||||||0.32
72474720|NCT02001064|144473892|SUPERIORITY|||||||0.073||||||Cohen's d (ranks) = -.049|Wilcoxon (Mann-Whitney)|||||||0.073
72474721|NCT02001064|144473893|SUPERIORITY|||||||0.24||||||Cohen's d=0.31|Wilcoxon (Mann-Whitney)|||||||0.24
72474722|NCT02314780|144473942|OTHER||||||=|0.001|||||||ANOVA|||||||=0.001
72474723|NCT02314780|144473943|OTHER||||||=|0.002|||||||ANOVA|||||||=0.002
72474724|NCT02314780|144473944|OTHER||||||=|0.002|||||||ANOVA|||||||=0.002
72474725|NCT02314780|144473945|OTHER||||||<|0.001|||||||ANOVA|||||||<0.001
72474726|NCT02314780|144473946|OTHER||||||=|0.138|||||||ANOVA|||||||=0.138
72474727|NCT02314780|144473947|OTHER||||||=|0.696|||||||ANOVA|||||||=0.696
72474728|NCT00215137|144473958|SUPERIORITY_OR_OTHER|||||||0.0002|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||A Wilcoxon Signed Rank test was performed on the difference between the open label endpoint and baseline YBOCS scores.||||0.0002
72398400|NCT00546637|144303179|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.7|STANDARD_ERROR_OF_MEAN|0.9||0.004||95.0|-4.5|-0.9||P-value was based on ANCOVA model with terms for country, treatment, and baseline value as covariate. No adjustment of p-value was made for multiple comparisons.|ANCOVA||Mean difference (net) = Least squares mean|Week 4||-0.9|-4.5|0.0040
72398401|NCT00546637|144303179|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.8|STANDARD_ERROR_OF_MEAN|1.0||0.0068||95.0|-4.8|-0.8||P-value was based on ANCOVA model with terms for country, treatment, and baseline value as covariate. No adjustment of p-value was made for multiple comparisons.|ANCOVA||Mean difference (net) = Least squares mean|Week 12||-0.8|-4.8|0.0068
72398402|NCT00546637|144303180|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.9|STANDARD_ERROR_OF_MEAN|0.9||0.0412||95.0|0.1|3.6||P-value was based on ANCOVA model with terms for country, treatment, and baseline value as covariate. No adjustment of p-value was made for multiple comparisons.|ANCOVA||Mean Difference (net)= Least squares mean|Week 4||3.6|0.1|0.0412
72398403|NCT00546637|144303180|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.5|STANDARD_ERROR_OF_MEAN|1.0||0.1373||95.0|-0.5|3.4||P-value was based on ANCOVA model with terms for country, treatment, and baseline value as covariate. No adjustment of p-value was made for multiple comparisons.|ANCOVA||Mean Difference (net)= Least squares mean|Week 12||3.4|-0.5|0.1373
72474729|NCT00215137|144473958|SUPERIORITY_OR_OTHER|||||||0.0417|TWO_SIDED|95.0|||||Wilcoxon Rank Sum Test|||A Wilcoxon Rank Sum Test was performed on the difference in the pre and post randomization YBOCS scores, using grouping to either escitalopram or placebo as a grouping variable.||||.0417
72474730|NCT02787044|144473997|SUPERIORITY||Hazard Ratio (HR)|1.06||||0.21|TWO_SIDED|95.0|0.97|1.17|||Regression, Cox|||Note, each participant can be included in the primary analysis up to 3 times (participating seasons).||1.17|0.97|0.21
72474731|NCT02787044|144473998|SUPERIORITY||Hazard Ratio (HR)|1.04||||0.44|TWO_SIDED|95.0|0.94|1.15|||Regression, Cox|||||1.15|0.94|0.44
72474732|NCT02787044|144473999|SUPERIORITY||Hazard Ratio (HR)|1.08||||0.16|TWO_SIDED|95.0|0.97|1.2|||Regression, Cox|||Each participant can be analyzed up to three times (seasons)||1.2|.97|0.16
72566084|NCT03135899|144662924|OTHER||Mean Difference (Final Values)|-0.037|STANDARD_ERROR_OF_MEAN|0.064|||TWO_SIDED|90.0|-0.144|0.07|||Mixed Models Analysis||BI 443651 400 μg is compared to placebo.|The mixed effects model included 'treatment' and 'period' as fixed effects, 'patient' as a random effect, and 'period baseline' as well as 'patient baseline' as covariates. No hypothesis was tested. The patient baseline was obtained by calculating the mean of the period baselines for each patient. Covariance structure variance component (VC) was used for random subject effect.||0.070|-0.144|
72398404|NCT00546637|144303181|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.7|STANDARD_ERROR_OF_MEAN|1.0||0.0941||95.0|-0.3|3.8||P-value was based on ANCOVA model with terms for country, treatment, and baseline value as covariate. No adjustment of p-value was made for multiple comparisons.|ANCOVA||Mean Difference (net) = Least squares mean|Week 4||3.8|-0.3|0.0941
72474733|NCT02787044|144474000|SUPERIORITY||Hazard Ratio (HR)|1.05||||0.26|TWO_SIDED|95.0|0.96|1.15|||Regression, Cox|||||1.15|.96|0.26
72474734|NCT02787044|144474001|SUPERIORITY||Hazard Ratio (HR)|1.01||||0.96|TWO_SIDED|95.0|0.84|1.21|||Regression, Cox|||||1.21|0.84|0.96
72474735|NCT03151993|144474030|NON_INFERIORITY|The non-inferiority hypothesis would be declared if the lower limit of the 95% CI for an mRS score of 0-1 on day 90 did not cross the margin of noninferiority of 16%. The non-inferiority hypothesis was tested using Welch's t-test for the primary outcome only.|Odds Ratio (OR)|9.5|||<|0.01|TWO_SIDED|95.0|-1.7|20.7|||Welch's t-test|||||20.7|-1.7|<0.01
72398405|NCT00546637|144303181|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.3|STANDARD_ERROR_OF_MEAN|1.1||0.2273||95.0|-0.8|3.4||P-value was based on ANCOVA model with terms for country, treatment, and baseline value as covariate. No adjustment of p-value was made for multiple comparisons.|ANCOVA||Mean Difference (net) = Least squares mean|Week 12||3.4|-0.8|0.2273
72398406|NCT00546637|144303182|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.1|STANDARD_ERROR_OF_MEAN|1.1||0.0507||95.0|0.0|4.3||P-value was based on ANCOVA model with terms for country, treatment, and baseline value as covariate. No adjustment of p-value was made for multiple comparisons.|ANCOVA||Mean Difference (net)= Least squares mean|Week 4||4.3|-0.0|0.0507
72398407|NCT00546637|144303182|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.9|STANDARD_ERROR_OF_MEAN|1.2||0.1136||95.0|-0.4|4.1||P-value was based on ANCOVA model with terms for country, treatment, and baseline value as covariate. No adjustment of p-value was made for multiple comparisons.|ANCOVA||Mean Difference (net)= Least squares mean|Week 12||4.1|-0.4|0.1136
72398408|NCT00546637|144303183|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.9|STANDARD_ERROR_OF_MEAN|1.1||0.0845||95.0|-0.3|4.1||P-value was based on ANCOVA model with terms for country, treatment, and baseline value as covariate. No adjustment of p-value was made for multiple comparisons.|ANCOVA||Mean Difference (net)= Least squares mean|Week 4||4.1|-0.3|0.0845
72474736|NCT04155047|144474037|SUPERIORITY||Least Squares Mean Difference|-0.323|STANDARD_ERROR_OF_MEAN|0.1861||0.0987|TWO_SIDED|95.0|-0.711|0.066|||Mixed Models Analysis|||||0.066|-0.711|0.0987
72474737|NCT04488770|144474090|OTHER||Ratio of Geometric Mean|0.75|||||TWO_SIDED|90.0|0.61|0.93|||||Mixed Effect Model has been used to assess Food Effect for the log transformed parameter AUC(0-24). Treatment in the fed/fasted state is fitted as Fixed Effect. Participant is fitted as Random Effect. Unstructured covariance structure is used.|||0.93|0.61|
72474738|NCT04488770|144474091|OTHER||Ratio of Geometric Mean|0.8|||||TWO_SIDED|90.0|0.65|0.98|||||Mixed Effect Model was used to assess Food Effect for the log transformed parameter AUC(0-t). Treatment in the fed/fasted state was fitted as Fixed Effect. Participant was fitted as Random Effect. Unstructured covariance structure was used.|||0.98|0.65|
72474739|NCT04488770|144474092|OTHER||Ratio of Geometric Mean|0.8|||||TWO_SIDED|90.0|0.65|0.98|||||Mixed Effect Model was used to assess Food Effect for log transformed parameter AUC(0-infinity). Treatment in the fed/fasted state was fitted as Fixed Effect. Participant was fitted as Random Effect. Unstructured covariance structure was used.|||0.98|0.65|
72474740|NCT04488770|144474093|OTHER||Ratio of Geometric Mean|0.59|||||TWO_SIDED|90.0|0.46|0.75|||||Mixed Effect Model was used to assess Food Effect for the log transformed parameter Cmax. Treatment in the fed/fasted state was fitted as Fixed Effect. Participant was fitted as Random Effect. Unstructured covariance structure was used.|||0.75|0.46|
72474741|NCT04488770|144474094|OTHER||Ratio of Geometric Mean|0.91|||||TWO_SIDED|90.0|0.74|1.11|||||Mixed Effect Model was used to assess Food Effect for the log transformed parameter C24h. Treatment in the fed/fasted state was fitted as Fixed Effect. Participant was fitted as Random Effect. Unstructured covariance structure was used.|||1.11|0.74|
72474742|NCT04488770|144474095|OTHER||Median Difference (Net)|0.0|||||TWO_SIDED|90.0|0.0|2.0|||||Wilcoxon matched pair test was used to assess Food Effect for the parameter Tmax.|||2.000|0.000|
72474743|NCT04488770|144474096|OTHER||Median Difference (Net)|0.0|||||TWO_SIDED|90.0|0.0|0.25|||||Wilcoxon matched pair test was used to assess Food Effect for the parameter Tlag.|||0.250|0.000|
72474744|NCT01417104|144474104|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.16|||<|0.031|TWO_SIDED|95.0|0.85|9.47|||t-test, 2 sided|||||9.47|0.85|<0.031
72474745|NCT01417104|144474105|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.4||||0.041|TWO_SIDED|95.0|0.44|4.36|||t-test, 2 sided|||||4.36|0.44|0.041
72474746|NCT03361605|144474107|SUPERIORITY|"Our study adopted a within-subject design, which is not a randomized controlled trial (RCT) such as testing if one treatment is superior to another. Therefore, here the Superiority indicates if propofol administration has a statistically significant impact on the brain activity in response to sensory stimuli."|Mean Difference (Net)|-0.349|STANDARD_DEVIATION|0.223|<|0.0001|TWO_SIDED|||||The threshold for statistical significance was p=0.05. The p-value was not adjusted for multiple comparisons, as only one comparison was performed.|t-test, 2 sided||Difference = BOLD Response During Sedation - BOLD Response During Baseline|The null hypothesis is no difference in BOLD response between sedated state and baseline.||||<0.0001
72474747|NCT03361605|144474108|SUPERIORITY|"Our study adopted a within-subject design, which is not a randomized controlled trial (RCT) such as testing if one treatment is superior to another. Therefore, here the Superiority indicates if propofol administration has a statistically significant impact on the squeeze pressure in response to verbal instructions."|Mean Difference (Net)|-2.16|STANDARD_DEVIATION|3.09||0.00148|TWO_SIDED|||||The threshold for statistical significance was p=0.05. The p-value was not adjusted for multiple comparisons, as only one comparison was performed.|t-test, 2 sided||Difference = Squeeze Pressure During Sedation - Squeeze Pressure During Baseline|The null hypothesis is no difference in squeeze pressure between sedated state and baseline.||||0.00148
72474748|NCT01305408|144474109|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.4||||0.2717|TWO_SIDED|95.0|-3.76|1.06||Statistical tests were 2-tailed at the 0.05 level of significance.|mixed-model repeated measures (MMRM)|Treatment, visit, treatment-by-visit interaction, concurrent mood-stabilizing medication, and region of the world used as fixed factors.||||1.06|-3.76|0.2717
72474749|NCT00799981|144474148|OTHER|||||||0.8762|||||||Wilcoxon (Mann-Whitney)|||The hypothesis that a 10 cm catheter provides equal emptying of the bladder as a 7 cm catheter was tested.||||0.8762
72474750|NCT00799981|144474149|OTHER|||||||0.7905|||||||McNemar|||||||0.7905
72474751|NCT00799981|144474150|OTHER|||||||1|||||||McNemar|||||||1.00
72474752|NCT00799981|144474153|OTHER|||||||0.0273|||||||Wilcoxon (Mann-Whitney)|||In the table 0=No and 1=Yes.||||0.0273
72474753|NCT03653208|144474161|OTHER||Slope|1.01||||0.1075|TWO_SIDED|90.0|||||Kruskal-Wallis|||||||0.1075
72474754|NCT03653208|144474162|OTHER||Slope|1.2||||0.0548|TWO_SIDED|90.0|||||Kruskal-Wallis|||||||0.0548
72474755|NCT03752970|144474230|OTHER||Risk Difference (RD)|-0.609|||||TWO_SIDED|95.0|-0.88|-0.186||||||||-0.186|-0.880|
72474756|NCT03752970|144474231|OTHER||Risk Difference (RD)|-0.509|||||TWO_SIDED|95.0|-0.816|-0.087||||||||-0.087|-0.816|
72474757|NCT03752970|144474232|OTHER||Risk Difference (RD)|-0.509|||||TWO_SIDED|95.0|-0.816|-0.087||||||||-0.087|-0.816|
72474758|NCT01669577|144474281|SUPERIORITY_OR_OTHER||GEE(Generalyzed Estimation Equation)|0.989214|||<|0.001|TWO_SIDED|95.0|0.982855|0.995613||arterial hemoglobin Oxygen saturation|ANOVA|Non parametric(NPar) ANOVA|GEE model (dichotomous response variable)with logit link function. The NPar ANOVA (p\<0.1 for death) was the test used for inclusion in the model variables for the final models - backward method, with alpha equal to 0.05.|"significance level of 0.05, power of 0.80, moderate correlation of 0.5 between time periods and assumption that the variability is equal within each factor (non-sphericity). Due to the effect size between 0.1 and 0.5, there was no need for samples larger than 140 patients. A total of 200 patients was defined conservatively, with a margin for possible deaths. The software G\*Power 3.1.7 was used for sample size calculation.~Fischer's test, Mann-Whitney, t-test; Non parametric ANOVA and GEE"||0.995613|0.982855|< 0.001
72474759|NCT01669577|144474281|SUPERIORITY_OR_OTHER||GEE|0.99728|||<|0.001|TWO_SIDED|95.0|0.995791|0.998772|||ANOVA|||diastolic arterial blood pressure||0.998772|0.995791|< 0.001
72474760|NCT01669577|144474281|SUPERIORITY_OR_OTHER||GEE|1.046961|||<|0.004|TWO_SIDED|95.0|1.012521|1.082572|||ANOVA|||lactate||1.082572|1.012521|< 0.004
72474761|NCT01669577|144474281|SUPERIORITY_OR_OTHER||GEE|0.973987|||<|0.001|TWO_SIDED|95.0|0.965308|0.982744|||ANOVA|||Glasgow coma score||0.982744|0.965308|<0.001
72474762|NCT01669577|144474281|SUPERIORITY_OR_OTHER||GEE|1.000013|||<|0.023|TWO_SIDED|95.0|1.0|1.000025|||ANOVA|||amount of Infused crystalloids||1.000025|1.000000|<0.023
72474763|NCT02045875|144474320|SUPERIORITY|||||||0.046||||||Effect of interaction of time and treatment group|ANOVA|||||||0.046
72474764|NCT02045875|144474321|OTHER||correlation coefficient|-0.508|||||TWO_SIDED||||||||correlation of asthma control and adherence|||||
72474765|NCT01114880|144474328|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||||||< 0.001
72474766|NCT01114880|144474330|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||||||< 0.001
72474767|NCT01114880|144474332|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||||||< 0.001
72474768|NCT01114880|144474334|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||||||< 0.001
72474769|NCT01114880|144474336|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||||||< 0.001
72474770|NCT01114880|144474338|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared, Corrected|||||||< 0.001
72474771|NCT01114880|144474340|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||||||< 0.001
72474772|NCT01114880|144474342|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||||||< 0.001
72474773|NCT01114880|144474344|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||||||< 0.001
72507294|NCT03151148|144546504|SUPERIORITY||Geometric mean ratio (GMR)|0.75||||0.526|TWO_SIDED|95.0|0.315|1.805|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator.|"TMT vs Placebo on Lesional Skin at Day 11~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||1.805|0.315|0.526
72474774|NCT01114880|144474346|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||||||< 0.001
72474775|NCT01114880|144474348|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||||||< 0.001
72474776|NCT01743989|144474425|SUPERIORITY|||||||0.383|||||||Chi-squared|||||||0.383
72474777|NCT00515723|144474448|SUPERIORITY|||||||0.002||||||The a priori threshold for statistical significance in this planned primary test was p\<0.05.|Mixed Models Analysis|||Primary analysis for change in DEXA total fat used a likelihood-based mixed-effects model using time (0, 6, and 12 weeks) as the independent variable, with Toeplitz covariance structure specified, based on Akaike Information Criterion-Corrected (AIC-C). The null hypothesis was that there was no difference in the outcome over time (main effect of time).||||0.002
72474778|NCT00515723|144474448|SUPERIORITY|||||||0.002||||||The a priori threshold for statistical significance in this planned primary test was p\<0.05.|Mixed Models Analysis|||Primary analysis for change in DEXA total fat used a likelihood-based mixed-effects model using time (0, 6, and 12 weeks) and treatment group as independent variables, with Toeplitz covariance structure specified, based on Akaike Information Criterion-Corrected (AIC-C). The null hypothesis was that there were no differences between groups in the change over time (time by treatment condition).||||0.002
72474779|NCT00515723|144474449|SUPERIORITY|||||||0.05||||||The a priori threshold for statistical significance in this planned primary test was p\<0.05.|Mixed Models Analysis|||Primary analysis for change in insulin sensitivity used a likelihood-based mixed-effects model using time (0 and 12 weeks) as the independent variable, with an unstructured covariance structure specified, based on the Akaike Information Criterion-Corrected (AIC-C). The null hypothesis was that there was no difference in the outcome over time (main effect of time).||||0.05
72474780|NCT00515723|144474449|SUPERIORITY|||||||0.22||||||The a priori threshold for statistical significance in this planned primary test was p\<0.05.|Mixed Models Analysis|||Primary analysis for change in insulin sensitivity used a likelihood-based mixed-effects model using time (0 and 12 weeks) and treatment group as the independent variables, with an unstructured covariance structure specified, based on the Akaike Information Criterion-Corrected (AIC-C). The null hypothesis was that there were no differences between groups in the change over time (time by treatment condition).||||0.22
72474781|NCT02626455|144474455|SUPERIORITY|Comparison of PFS|Hazard Ratio (HR)|1.125|||=|0.827974|TWO_SIDED|95.0|0.881|1.437||Significance level is 0.025.|Log Rank|PFS was evaluated with a one-sided stratified log- rank test. HR and 95% CI are based on the stratified Cox regression model.||||1.437|0.881|= 0.827974
72474782|NCT02626455|144474458|SUPERIORITY|ORR of Copa+R-B/R-CHOP minus ORR of Pbo+R-B/R-CHOP|Difference|-1.25|||=|0.658652|TWO_SIDED|95.0|-7.25|4.75||Significance level is 0.025. P-values are descriptive (nominal) due to multiplicity testing.|Cochran-Mantel-Haenszel|Point estimate and 95% CI are based on Mantel-Haenszel weighted treatment difference.||||4.75|-7.25|= 0.658652
72507295|NCT03151148|144546504|SUPERIORITY||Geometric mean ratio (GMR)|55.53|||<|0.001|TWO_SIDED|95.0|23.49|131.279|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator.|"TMT vs Placebo on Non-lesional Skin at Day 0 (post-treatment)~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||131.279|23.490|<0.001
72507296|NCT03151148|144546504|SUPERIORITY||Geometric mean ratio (GMR)|11.78|||<|0.001|TWO_SIDED|95.0|5.0|27.755|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator.|"TMT vs Placebo on Non-lesional Skin at Day 4~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||27.755|5.000|<0.001
72474783|NCT02626455|144474459|SUPERIORITY|ORR of Copa+R-B/R-CHOP minus ORR of Pbo+R-B/R-CHOP|Difference|-0.8|||=|0.605183|TWO_SIDED|95.0|-6.64|5.05||Significance level is 0.025. P-value is descriptive (nominal) due to multiplicity testing.|Cochran-Mantel-Haenszel|Point estimate and 95% CI are based on Mantel-Haenszel weighted treatment difference.||||5.05|-6.64|=0.605183
72474784|NCT02626455|144474460|SUPERIORITY|Comparison of DOR|Hazard Ratio (HR)|1.145|||=|0.846204|TWO_SIDED|95.0|0.883|1.484||Significance level is 0.025, P-value is descriptive (nominal) due to multiplicity testing.|Log Rank|DOR was evaluated with a one-sided stratified log-rank test. HR and its 95% CI were based on the stratified Cox regression model.||||1.484|0.883|= 0.846204
72474785|NCT02626455|144474461|SUPERIORITY|Comparison of DOR|Hazard Ratio (HR)|1.117|||=|0.801735|TWO_SIDED|95.0|0.865|1.443||Significance level is 0.025, P-value is descriptive (nominal) due to multiplicity testing.|Log Rank|DOR was evaluated with a one-sided stratified log-rank test. HR and its 95% CI were based on the stratified Cox regression model.||||1.443|0.865|= 0.801735
72474786|NCT02626455|144474462|SUPERIORITY|CRR of Copa+R-B/R-CHOP minus CRR of Pbo+R-B/R-CHOP|Difference|-2.74|||=|0.741153|TWO_SIDED|95.0|-11.06|5.57||Significance level is 0.025. P-value is descriptive (nominal) due to multiplicity testing.|Cochran-Mantel-Haenszel|Point estimate and 95% CI are based on Mantel-Haenszel weighted treatment difference.||||5.57|-11.06|= 0.741153
72566085|NCT03135899|144662924|OTHER||Mean Difference (Final Values)|-0.157|STANDARD_ERROR_OF_MEAN|0.066|||TWO_SIDED|90.0|-0.266|-0.047|||Mixed Models Analysis||BI 443651 1200 μg is compared to placebo.|The mixed effects model included 'treatment' and 'period' as fixed effects, 'patient' as a random effect, and 'period baseline' as well as 'patient baseline' as covariates. No hypothesis was tested. The patient baseline was obtained by calculating the mean of the period baselines for each patient. Covariance structure variance component (VC) was used for random subject effect.||-0.047|-0.266|
72398409|NCT00546637|144303183|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.2|STANDARD_ERROR_OF_MEAN|1.2||0.0662||95.0|-0.2|4.6||P-value was based on ANCOVA model with terms for country, treatment, and baseline value as covariate. No adjustment of p-value was made for multiple comparisons.|ANCOVA||Mean Difference (net) = Least squares mean|Week 12||4.6|-0.2|0.0662
72474787|NCT02626455|144474463|SUPERIORITY|CRR of Copa+R-B/R-CHOP minus CRR of Pbo+R-B/R-CHOP|Difference|-2.21|||=|0.696482|TWO_SIDED|95.0|-10.62|6.2||Significance level is 0.025. P-value is descriptive (nominal) due to multiplicity testing.|Cochran-Mantel-Haenszel|Point estimate and 95% CI are based on Mantel-Haenszel weighted treatment difference.||||6.20|-10.62|= 0.696482
72474788|NCT02626455|144474464|SUPERIORITY|DCR of Copa+R-B/R-CHOP minus DCR of Pbo+R-B/R-CHOP|Difference|-3.95|||=|0.936009|TWO_SIDED|95.0|-9.04|1.14||Significance level is 0.025. P-value is descriptive (nominal) due to multiplicity testing.|Cochran-Mantel-Haenszel|Point estimate and 95% CI are based on Mantel-Haenszel weighted treatment difference||||1.14|-9.04|= 0.936009
72474789|NCT02626455|144474465|SUPERIORITY|DCR of Copa+R-B/R-CHOP minus DCR of Pbo+R-B/R-CHOP|Difference|-3.89|||=|0.944242|TWO_SIDED|95.0|-8.68|0.9||Significance level is 0.025. P-value is descriptive (nominal) due to multiplicity testing.|Cochran-Mantel-Haenszel|Point estimate and 95% CI are based on Mantel-Haenszel weighted treatment difference||||0.90|-8.68|= 0.944242
72474790|NCT02626455|144474466|SUPERIORITY|Comparison of TTP|Hazard Ratio (HR)|1.006|||=|0.517849|TWO_SIDED|95.0|0.777|1.303||Significance level is 0.025. P-value is descriptive (nominal) due to multiplicity testing.|Log Rank|TTP was evaluated with a one-sided stratified log-rank test. HR and its 95% CI are based on the stratified Cox regression model.||||1.303|0.777|= 0.517849
72474791|NCT02626455|144474467|SUPERIORITY|Comparison of TTP|Hazard Ratio (HR)|0.971|||=|0.411398|TWO_SIDED|95.0|0.75|1.257||Significance level is 0.025. P-value is descriptive (nominal) due to multiplicity testing.|Log Rank|TTP was evaluated with a one-sided stratified log-rank test. HR and its 95% CI are based on the stratified Cox regression model.||||1.257|0.750|= 0.411398
72474792|NCT02626455|144474468|SUPERIORITY|Comparison of TTNT|Hazard Ratio (HR)|1.289|||=|0.955865|TWO_SIDED|95.0|0.962|1.728||Significance level IS 0.025. P-value is descriptive (nominal) due to multiplicity testing.|Log Rank|TTNT was evaluated with a one-sided stratified log-rank test. HR and its 95% CI are based on the stratified Cox regression model.||||1.728|0.962|= 0.955865
72474793|NCT02626455|144474469|SUPERIORITY|Comparison of OS|Hazard Ratio (HR)|1.132|||=|0.758563|TWO_SIDED|95.0|0.8|1.603||Significance level is 0.025. P-value is descriptive (nominal) due to multiplicity testing.|Log Rank|OS was evaluated with a one-sided stratified log-rank test. HR and 95% CI are based on the stratified Cox regression model.||||1.603|0.800|= 0.758563
72474794|NCT02626455|144474470|SUPERIORITY|Comparison of time to deterioration in DRS-P|Hazard Ratio (HR)|1.394|||=|0.999695|TWO_SIDED|95.0|1.149|1.691||Significance level IS 0.025. P-value is descriptive (nominal) due to multiplicity testing.|Log Rank|Time to deterioration in DRS-P was evaluated with one-sided stratified log-rank test.HR and its 95% CI are based on stratified Cox regression model.||||1.691|1.149|= 0.999695
72474795|NCT02626455|144474471|SUPERIORITY|Comparison of time to improvement in DRS-P|Hazard Ratio (HR)|0.81|||=|0.965639|TWO_SIDED|95.0|0.642|1.02||Significance level is 0.025. P-value is descriptive (nominal) due to multiplicity testing.|Log Rank|Time to improvement in DRS-P was evaluated with one-sided stratified log-rank test.HR and its 95% CI are based on the stratified Cox regression model.||||1.020|0.642|= 0.965639
72474796|NCT01882543|144474491|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0||||0.061|TWO_SIDED|95.0|-2.1|0.0|||ANCOVA|||A sample size of 28 subjects per group had 80% power to detect a 1.5-point difference in the change from baseline pain score between AQX-1125 and placebo assuming a between-subject SD of 2.0 and a 2-sided 5% significance level. Average daily pain scores were calculated using an average of up to the last 7 recordings within 9 days before each visit. Missing data, including premature discontinuation, was imputed using the LOCF approach for the primary efficacy end point of average daily pain score||0.0|-2.1|0.061
72474797|NCT01882543|144474492|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.3||||0.03|TWO_SIDED|95.0|-2.5|-0.1|||ANCOVA|||E-diary maximum daily pain scores were calculated using an average of up to the last 7 recordings within 9 days before each visit. Missing data, including premature discontinuation, was imputed using the LOCF approach for the secondary efficacy variable of maximum daily pain score||-0.1|-2.5|0.030
72474798|NCT01882543|144474493|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.6||||0.008|TWO_SIDED|95.0|-2.8|-0.5|||ANCOVA|||Analyses of the secondary variable was based on observed data without imputation.||-0.5|-2.8|0.008
72474799|NCT01882543|144474494|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.6||||0.028|TWO_SIDED|95.0|-3.0|-0.2|||ANCOVA|||Analyses of the secondary variable was based on observed data without imputation.||-0.2|-3.0|0.028
72474800|NCT01882543|144474495|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.4||||0.011|TWO_SIDED|95.0|-9.5|-1.3|||ANCOVA|||Analyses of the secondary variable was based on observed data without imputation.||-1.3|-9.5|0.011
72474801|NCT01882543|144474496|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.1||||0.007|TWO_SIDED|95.0|-8.8|-1.4||ICSI/PI|ANCOVA|||Analyses of the secondary variable was based on observed data without imputation.||-1.4|-8.8|0.007
72474802|NCT01882543|144474496|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.7||||0.005|TWO_SIDED|95.0|-4.6|-0.9||ICSI|ANCOVA|||Analyses of the secondary variable was based on observed data without imputation.||-0.9|-4.6|0.005
72474803|NCT01882543|144474496|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.5||||0.014|TWO_SIDED|95.0|-4.5|-0.5||ICPI|ANCOVA|||Analyses of the secondary variable was based on observed data without imputation.||-0.5|-4.5|0.014
72474804|NCT01882543|144474497|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.3||||0.592|TWO_SIDED|95.0|-6.3|3.6||Mental Component|ANCOVA|||Analyses of the secondary variable was based on observed data without imputation.||3.6|-6.3|0.592
72623094|NCT01385995|144776488|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.1||||0.08|TWO_SIDED|95.0|-27.5|1.8|||Regression, Linear|Adjusted for period, baseline level of the outcome variable, BMI, AHI, gender and race.||Based on an intent-to-treat approach, a linear mixed effect model was used to estimate the association between therapy and measures of insulin resistance, in this case Homeostasis Model Assessment-Insulin Resistance (HOMA-IR), between CPAP and sham-CPAP, stratified for the most severe sleep apnea group (Apnea-Hypopnea Index (AHI) \>=30) in order to assess whether the differences in the effect of CPAP on outcomes were observed according to sleep apnea severity. N=23.||1.8|-27.5|0.08
72623095|NCT01385995|144776489|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.7||||0.2|TWO_SIDED|95.0|-2.0|9.8|||Regression, Linear|Adjusted for period, baseline level of the outcome variable, BMI, Apnea-Hypopnea Index (AHI), gender and race.||Based on an intent-to-treat approach, a linear mixed effect model was used to estimate the association between therapy and the Insulin Sensivity Index, between CPAP and sham-CPAP.||9.8|-2.0|0.20
72623096|NCT01385995|144776489|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.3||||0.002|TWO_SIDED|95.0|5.2|22.1|||Regression, Linear|Adjusted for period, baseline level of the outcome variable, BMI, AHI, gender and race.||Based on an intent-to-treat approach, a linear mixed effect model was used to estimate the association between therapy and the Insulin Sensitivity Index (ISI(0,120)), between CPAP and sham-CPAP, stratified for the most severe sleep apnea group (Apnea-Hypopnea Index (AHI) \>=30) in order to assess whether the differences in the effect of CPAP on outcomes were observed according to sleep apnea severity. N=23.||22.1|5.2|0.002
72474805|NCT01882543|144474497|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.5||||0.221|TWO_SIDED|95.0|-1.6|6.7||Physical Component|ANCOVA|||Analyses of the secondary variable was based on observed data without imputation.||6.7|-1.6|0.221
72474806|NCT01882543|144474498|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.8||||0.04|TWO_SIDED|95.0|-5.5|-0.1|||ANOVA|||Analyses of the secondary variable was based on observed data without imputation.||-0.1|-5.5|0.040
72398410|NCT00546637|144303184|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.4|STANDARD_ERROR_OF_MEAN|0.9||0.1085||95.0|-0.3|3.2||P-value was based on ANCOVA model with terms for country, treatment, and baseline value as covariate. No adjustment of p-value was made for multiple comparisons.|ANCOVA||Mean Difference (net) = Least squares mean|Week 4||3.2|-0.3|0.1085
72474807|NCT00926497|144474510|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||Fisher Exact|||The trial was designed to obtain a power of 90% to detect a 30% difference between the two groups in the duration of antibiotic therapy with an estimated standard deviation of 50%.||||0.002
72474808|NCT00926497|144474511|SUPERIORITY_OR_OTHER|||||||0.012||95.0|||||t-test, 2 sided|||||||0.012
72474809|NCT00926497|144474511|SUPERIORITY_OR_OTHER|||||||0.004||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.004
72474810|NCT02040584|144474590|SUPERIORITY_OR_OTHER|||||||0.9423|||||||Fisher Exact|Week 52||"Null hypothesis (H0): there were no differences in kidney function between the two groups, in contrast with the alternative hypothesis (H1), in which there were differences:~HO: CBS = CBC versus H1: CBS ≠ CBC, where CBS and CBC were percentages of patients who showed clinical benefit at Week 52 for the study group and control group, respectively."||||0.9423
72474811|NCT02236988|144474639|OTHER||Ratio of Adjusted Geometric Means|65.3|||||TWO_SIDED|90.0|55.0|77.6|||||Ratio of adjusted geometric means (Apremilast Modified Release 1 / Apremilast Immediate Release) expressed as a percentage.|To compare each test formulation with the reference formulation in each group, an analysis of variance (ANOVA) was performed on the natural log-transformed Cmax value. The ANOVA model included treatment, sequence, and period as fixed effects and subject nested within sequence as a random effect.||77.6|55.0|
72474812|NCT02236988|144474639|OTHER||Ratio of Adjusted Geometric Means|80.4|||||TWO_SIDED|90.0|67.8|95.5|||||Ratio of adjusted geometric means (Apremilast Modified Release 2 / Apremilast Immediate Release) expressed as a percentage.|To compare each test formulation with the reference formulation in each group, an ANOVA was performed on the natural log-transformed Cmax value. The ANOVA model included treatment, sequence, and period as fixed effects and subject nested within sequence as a random effect.||95.5|67.8|
72474813|NCT02236988|144474639|OTHER||Ratio of Adjusted Geometric Means|84.2|||||TWO_SIDED|90.0|70.9|99.9|||||Ratio of adjusted geometric means (Apremilast Modified Release 3 / Apremilast Immediate Release) expressed as a percentage.|To compare each test formulation with the reference formulation in each group, an ANOVA was performed on the natural log-transformed Cmax value. The ANOVA model included treatment, sequence, and period as fixed effects and subject nested within sequence as a random effect.||99.9|70.9|
72474814|NCT02236988|144474641|OTHER||Ratio of Adjusted Geometric Means|61.8|||||TWO_SIDED|90.0|51.7|73.9|||||Ratio of adjusted geometric means (Apremilast Modified Release 1 / Apremilast Immediate Release) expressed as a percentage.|To compare each test formulation with the reference formulation in each group, an ANOVA was performed on the natural log-transformed AUC0-t value. The ANOVA model included treatment, sequence, and period as fixed effects and subject nested within sequence as a random effect.||73.9|51.7|
72474815|NCT02236988|144474641|OTHER||Ratio of Adjusted Geometric Means|71.2|||||TWO_SIDED|90.0|59.6|85.1|||||Ratio of adjusted geometric means (Apremilast Modified Release 2 / Apremilast Immediate Release) expressed as a percentage.|To compare each test formulation with the reference formulation in each group, an ANOVA was performed on the natural log-transformed AUC0-t value. The ANOVA model included treatment, sequence, and period as fixed effects and subject nested within sequence as a random effect.||85.1|59.6|
72474816|NCT02236988|144474641|OTHER||Ratio of Adjusted Geometric Means|73.8|||||TWO_SIDED|90.0|61.7|88.2|||||Ratio of adjusted geometric means (Apremilast Modified Release 3 / Apremilast Immediate Release) expressed as a percentage.|To compare each test formulation with the reference formulation in each group, an ANOVA was performed on the natural log-transformed AUC0-t value. The ANOVA model included treatment, sequence, and period as fixed effects and subject nested within sequence as a random effect.||88.2|61.7|
72507297|NCT03151148|144546504|SUPERIORITY||Geometric mean ratio (GMR)|23.17|||<|0.001|TWO_SIDED|95.0|9.833|54.579|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator.|"TMT vs Placebo on Non-lesional Skin at Day 7~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||54.579|9.833|<0.001
72474817|NCT02236988|144474642|OTHER||Ratio of Adjusted Geometric Means|62.3|||||TWO_SIDED|90.0|52.1|74.4|||||Ratio of adjusted geometric means (Apremilast Modified Release 1 / Apremilast Immediate Release) expressed as a percentage.|To compare each test formulation with the reference formulation in each group, an ANOVA was performed on the natural log-transformed AUC0-∞ value. The ANOVA model included treatment, sequence, and period as fixed effects and subject nested within sequence as a random effect.||74.4|52.1|
72474818|NCT02236988|144474642|OTHER||Ratio of Adjusted Geometric Means|71.3|||||TWO_SIDED|90.0|59.7|85.2|||||Ratio of adjusted geometric means (Apremilast Modified Release 2 / Apremilast Immediate Release) expressed as a percentage.|To compare each test formulation with the reference formulation in each group, an ANOVA was performed on the natural log-transformed AUC0-∞ value. The ANOVA model included treatment, sequence, and period as fixed effects and subject nested within sequence as a random effect.||85.2|59.7|
72474819|NCT02236988|144474642|OTHER||Ratio of Adjusted Geometric Means|74.0|||||TWO_SIDED|90.0|62.0|88.4|||||Ratio of adjusted geometric means (Apremilast Modified Release 3 / Apremilast Immediate Release) expressed as a percentage.|To compare each test formulation with the reference formulation in each group, an ANOVA was performed on the natural log-transformed AUC0-∞ value. The ANOVA model included treatment, sequence, and period as fixed effects and subject nested within sequence as a random effect.||88.4|62.0|
72474820|NCT02236988|144474643|OTHER||Median Difference|1.0||||0.009|TWO_SIDED|90.0|0.5|2.0|||Wilcoxon signed-rank test||Median difference (Apremilast Modified Release 1 - Apremilast Immediate Release) calculated from the Hodges-Lehmann estimate.|Tmax was analyzed by nonparametric methods. The median difference and 90% CI of the median difference were calculated from the Hodges-Lehrmann estimate.||2.00|0.5|0.0090
72474821|NCT02236988|144474643|OTHER||Median Difference|1.26||||0.0073|TWO_SIDED|90.0|0.5|3.0|||Wilcoxon signed-rank test||Median difference (Apremilast Modified Release 2 - Apremilast Immediate Release) calculated from the Hodges-Lehmann estimate.|Tmax was analyzed by nonparametric methods. The median difference and 90% CI of the median difference were calculated from the Hodges-Lehrmann estimate.||3.00|0.50|0.0073
72474822|NCT02236988|144474643|OTHER||Median Difference|2.0|||<|0.0001|TWO_SIDED|90.0|1.0|3.0|||Wilcoxon signed-rank test||Median difference (Apremilast Modified Release 3 - Apremilast Immediate Release) calculated from the Hodges-Lehmann estimate|Tmax was analyzed by nonparametric methods. The median difference and 90% CI of the median difference were calculated from the Hodges-Lehrmann estimate.||3.00|1.00|<0.0001
72474823|NCT02236988|144474649|OTHER||Ratio of Adjusted Geometric Means|90.9|||||TWO_SIDED|90.0|81.8|101.1|||||Ratio of adjusted geometric means (Apremilast Modified Release 4 / Apremilast Immediate Release) expressed as a percentage.|To compare each test formulation with the reference formulation in each group, an ANOVA was performed on the natural log-transformed Cmax value. The ANOVA model included treatment, sequence, and period as fixed effects and subject nested within sequence as a random effect.||101.1|81.8|
72474824|NCT02236988|144474649|OTHER||Ratio of Adjusted Geometric Means|73.7|||||TWO_SIDED|90.0|66.3|82.0|||||Ratio of adjusted geometric means (Apremilast Modified Release 5 / Apremilast Immediate Release) expressed as a percentage.|To compare each test formulation with the reference formulation in each group, an ANOVA was performed on the natural log-transformed Cmax value. The ANOVA model included treatment, sequence, and period as fixed effects and subject nested within sequence as a random effect.||82.0|66.3|
72474825|NCT02236988|144474649|OTHER||Ratio of Adjusted Geometric Means|80.2|||||TWO_SIDED|90.0|72.2|89.2|||||Ratio of adjusted geometric means (Apremilast Modified Release 6 / Apremilast Immediate Release) expressed as a percentage.|To compare each test formulation with the reference formulation in each group, an ANOVA was performed on the natural log-transformed Cmax value. The ANOVA model included treatment, sequence, and period as fixed effects and subject nested within sequence as a random effect.||89.2|72.2|
72474826|NCT02236988|144474650|OTHER||Ratio of Adjusted Geometric Means|84.9|||||TWO_SIDED|90.0|77.5|93.0|||||Ratio of adjusted geometric means (Apremilast Modified Release 4 / Apremilast Immediate Release) expressed as a percentage.|To compare each test formulation with the reference formulation in each group, an ANOVA was performed on the natural log-transformed AUC0-t value. The ANOVA model included treatment, sequence, and period as fixed effects and subject nested within sequence as a random effect.||93.0|77.5|
72474827|NCT02236988|144474650|OTHER||Ratio of Adjusted Geometric Means|72.0|||||TWO_SIDED|90.0|65.8|78.9|||||Ratio of adjusted geometric means (Apremilast Modified Release 5 / Apremilast Immediate Release) expressed as a percentage.|To compare each test formulation with the reference formulation in each group, an ANOVA was performed on the natural log-transformed AUC0-t value. The ANOVA model included treatment, sequence, and period as fixed effects and subject nested within sequence as a random effect.||78.9|65.8|
72474828|NCT02236988|144474650|OTHER||Ratio of Adjusted Geometric Means|78.0|||||TWO_SIDED|90.0|71.2|85.5|||||Ratio of adjusted geometric means (Apremilast Modified Release 6 / Apremilast Immediate Release) expressed as a percentage.|To compare each test formulation with the reference formulation in each group, an ANOVA was performed on the natural log-transformed AUC0-t value. The ANOVA model included treatment, sequence, and period as fixed effects and subject nested within sequence as a random effect.||85.5|71.2|
72566086|NCT03135899|144662926|OTHER||Geometric Mean Ratio|0.77|STANDARD_ERROR_OF_MEAN|1.168|||TWO_SIDED|90.0|0.595|0.977|||Mixed Models Analysis||BI 443651 100 μg is compared to placebo. Standard error of the mean is actually geometric standard error.|The mixed effects model included 'treatment' and 'period' as fixed effects, 'patient' as a random effect, and 'period baseline' as well as 'patient baseline' as covariates. No hypothesis was tested. The patient baseline was obtained by calculating the mean of the period baselines for each patient. Covariance structure variance component (VC) was used for random subject effect.||0.977|0.595|
72576826|NCT00261443|144680657|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.26||||0.034|TWO_SIDED|95.0|-0.5|-0.02||Baseline: ANOVA model, controlling for treatment, mood stabilizer, and index mood episode. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 32 Comparison||-0.02|-0.50|0.034
72474829|NCT02236988|144474651|OTHER||Ratio of Adjusted Geometric Means|85.5|||||TWO_SIDED|90.0|78.1|93.6|||||Ratio of adjusted geometric means (Apremilast Modified Release 4 / Apremilast Immediate Release) expressed as a percentage.|To compare each test formulation with the reference formulation in each group, an ANOVA was performed on the natural log-transformed AUC0-∞ value. The ANOVA model included treatment, sequence, and period as fixed effects and subject nested within sequence as a random effect.||93.6|78.1|
72474830|NCT02236988|144474651|OTHER||Ratio of Adjusted Geometric Means|72.6|||||TWO_SIDED|90.0|66.3|79.5|||||Ratio of adjusted geometric means (Apremilast Modified Release 5 / Apremilast Immediate Release) expressed as a percentage.|To compare each test formulation with the reference formulation in each group, an ANOVA was performed on the natural log-transformed AUC0-∞ value. The ANOVA model included treatment, sequence, and period as fixed effects and subject nested within sequence as a random effect.||79.5|66.3|
72474831|NCT02236988|144474651|OTHER||Ratio of Adjusted Geometric Means|78.9|||||TWO_SIDED|90.0|72.0|86.4|||||Ratio of adjusted geometric means (Apremilast Modified Release 6 / Apremilast Immediate Release) expressed as a percentage.|To compare each test formulation with the reference formulation in each group, an ANOVA was performed on the natural log-transformed AUC0-∞ value. The ANOVA model included treatment, sequence, and period as fixed effects and subject nested within sequence as a random effect.||86.4|72.0|
72474832|NCT02236988|144474652|OTHER||Median Difference|2.0||||0.0002|TWO_SIDED|90.0|1.0|3.0|||Wilcoxon signed-rank test||Median difference (Apremilast Modified Release 4 - Apremilast Immediate Release) calculated from the Hodges-Lehmann estimate.|Tmax was analyzed by nonparametric methods. The median difference and 90% CI of the median difference were calculated from the Hodges-Lehrmann estimate.||3.00|1.00|0.0002
72474833|NCT02236988|144474652|OTHER||Median Difference|1.02||||0.0049|TWO_SIDED|90.0|0.5|2.0|||Wilcoxon signed-rank test||Median difference (Apremilast Modified Release 5 - Apremilast Immediate Release) calculated from the Hodges-Lehmann estimate.|Tmax was analyzed by nonparametric methods. The median difference and 90% CI of the median difference were calculated from the Hodges-Lehrmann estimate.||2.00|0.50|0.0049
72474834|NCT02236988|144474652|OTHER||Median Difference|1.5||||0.001|TWO_SIDED|90.0|1.0|2.0|||Wilcoxon signed-rank test||Median difference (Apremilast Modified Release 6 - Apremilast Immediate Release) calculated from the Hodges-Lehmann estimate|Tmax was analyzed by nonparametric methods. The median difference and 90% CI of the median difference were calculated from the Hodges-Lehrmann estimate.||2.00|1.00|0.0010
72474835|NCT02236988|144474658|OTHER||Ratio of Adjusted Geometric Means|91.0|||||TWO_SIDED|90.0|80.4|103.0|||||Ratio of adjusted geometric means (Apremilast Modified Release 8 / Apremilast Immediate Release) expressed as a percentage.|To compare each test formulation with the reference formulation in each group, an ANOVA was performed on the natural log-transformed Cmax value. The ANOVA model included treatment, sequence, and period as fixed effects and subject nested within sequence as a random effect.||103.0|80.4|
72474836|NCT02236988|144474658|OTHER||Ratio of Adjusted Geometric Means|88.4|||||TWO_SIDED|90.0|78.1|100.0|||||Ratio of adjusted geometric means (Apremilast Modified Release 9 / Apremilast Immediate Release) expressed as a percentage.|To compare each test formulation with the reference formulation in each group, an ANOVA was performed on the natural log-transformed Cmax value. The ANOVA model included treatment, sequence, and period as fixed effects and subject nested within sequence as a random effect.||100.0|78.1|
72474837|NCT02236988|144474659|OTHER||Ratio of Adjusted Geometric Means|80.6|||||TWO_SIDED|90.0|73.8|88.0|||||Ratio of adjusted geometric means (Apremilast Modified Release 8 / Apremilast Immediate Release) expressed as a percentage.|To compare each test formulation with the reference formulation in each group, an ANOVA was performed on the natural log-transformed AUC0-t value. The ANOVA model included treatment, sequence, and period as fixed effects and subject nested within sequence as a random effect.||88.0|73.8|
72507298|NCT03151148|144546504|SUPERIORITY||Geometric mean ratio (GMR)|11.05|||<|0.001|TWO_SIDED|95.0|4.516|27.052|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator.|"TMT vs Placebo on Non-lesional Skin at Day 8~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||27.052|4.516|<0.001
72566087|NCT03135899|144662926|OTHER||Geometric Mean Ratio|0.926|STANDARD_ERROR_OF_MEAN|1.168|||TWO_SIDED|90.0|0.715|1.199|||Mixed Models Analysis||BI 443651 400 μg is compared to placebo. Standard error of the mean is actually geometric standard error.|The mixed effects model included 'treatment' and 'period' as fixed effects, 'patient' as a random effect, and 'period baseline' as well as 'patient baseline' as covariates. No hypothesis was tested. The patient baseline was obtained by calculating the mean of the period baselines for each patient. Covariance structure variance component (VC) was used for random subject effect.||1.199|0.715|
72623097|NCT04101331|144776613|OTHER|||||||0.051||||||One-sided p-value.|Exact binomial test|Exact binomial test compares versus a proportion of 0.25.||||||0.051
72474838|NCT02236988|144474659|OTHER||Ratio of Adjusted Geometric Means|78.5|||||TWO_SIDED|90.0|71.9|85.7|||||Ratio of adjusted geometric means (Apremilast Modified Release 9 / Apremilast Immediate Release) expressed as a percentage.|To compare each test formulation with the reference formulation in each group, an ANOVA was performed on the natural log-transformed AUC0-t value. The ANOVA model included treatment, sequence, and period as fixed effects and subject nested within sequence as a random effect.||85.7|71.9|
72474839|NCT02236988|144474660|OTHER||Ratio of Adjusted Geometric Means|81.1|||||TWO_SIDED|90.0|74.3|88.6|||||Ratio of adjusted geometric means (Apremilast Modified Release 8 / Apremilast Immediate Release) expressed as a percentage.|To compare each test formulation with the reference formulation in each group, an ANOVA was performed on the natural log-transformed AUC0-∞ value. The ANOVA model included treatment, sequence, and period as fixed effects and subject nested within sequence as a random effect.||88.6|74.3|
72474840|NCT02236988|144474660|OTHER||Ratio of Adjusted Geometric Means|79.0|||||TWO_SIDED|90.0|72.3|86.3|||||Ratio of adjusted geometric means (Apremilast Modified Release 9 / Apremilast Immediate Release) expressed as a percentage.|To compare each test formulation with the reference formulation in each group, an ANOVA was performed on the natural log-transformed AUC0-∞ value. The ANOVA model included treatment, sequence, and period as fixed effects and subject nested within sequence as a random effect.||86.3|72.3|
72474841|NCT02236988|144474661|OTHER||Median Difference|0.98||||0.0374|TWO_SIDED|90.0|0.02|1.5|||Wilcoxon signed-rank test||Median difference (Apremilast Modified Release 8 - Apremilast Immediate Release) calculated from the Hodges-Lehmann estimate.|Tmax was analyzed by nonparametric methods. The median difference and 90% CI of the median difference were calculated from the Hodges-Lehrmann estimate.||1.50|0.02|0.0374
72623098|NCT04101331|144776614|OTHER|||||||0.051||||||One-sided p-value.|Exact binomial test|Exact binomial test compares versus a proportion of 0.25.||||||0.051
72576827|NCT00261443|144680657|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.17||||0.174|TWO_SIDED|95.0|-0.41|0.07||Baseline: ANOVA model, controlling for treatment, mood stabilizer, and index mood episode. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 36 Comparison||0.07|-0.41|0.174
72474842|NCT02236988|144474661|OTHER||Median Difference|0.51||||0.1907|TWO_SIDED|90.0|0.0|1.5|||Wilcoxon signed-rank test||Median difference (Apremilast Modified Release 9 - Apremilast Immediate Release) calculated from the Hodges-Lehmann estimate.|Tmax was analyzed by nonparametric methods. The median difference and 90% CI of the median difference were calculated from the Hodges-Lehrmann estimate.||1.50|0.00|0.1907
72474843|NCT02236988|144474667|OTHER||Ratio of Adjusted Geometric Means|109.4|||||TWO_SIDED|90.0|98.6|121.3|||||Ratio of adjusted geometric means (Apremilast Modified Release 11 / Apremilast Immediate Release) expressed as a percentage.|To compare each test formulation with the reference formulation in each group, an ANOVA was performed on the natural log-transformed Cmax value. The ANOVA model included treatment, sequence, and period as fixed effects and subject nested within sequence as a random effect.||121.3|98.6|
72474844|NCT02236988|144474667|OTHER||Ratio of Adjusted Geometric Means|107.2|||||TWO_SIDED|90.0|96.4|119.2|||||Ratio of adjusted geometric means (Apremilast Modified Release 12 / Apremilast Immediate Release) expressed as a percentage.|To compare each test formulation with the reference formulation in each group, an ANOVA was performed on the natural log-transformed Cmax value. The ANOVA model included treatment, sequence, and period as fixed effects and subject nested within sequence as a random effect.||119.2|96.4|
72474845|NCT02236988|144474667|OTHER||Ratio of Adjusted Geometric Means|72.7|||||TWO_SIDED|90.0|65.5|80.8|||||Ratio of adjusted geometric means (Apremilast Modified Release 13 / Apremilast Immediate Release) expressed as a percentage.|To compare each test formulation with the reference formulation in each group, an ANOVA was performed on the natural log-transformed Cmax value. The ANOVA model included treatment, sequence, and period as fixed effects and subject nested within sequence as a random effect.||80.8|65.5|
72474846|NCT02236988|144474667|OTHER||Ratio of Adjusted Geometric Means|103.5|||||TWO_SIDED|90.0|93.1|114.9|||||Ratio of adjusted geometric means (Apremilast Modified Release 14 / Apremilast Immediate Release) expressed as a percentage.|To compare each test formulation with the reference formulation in each group, an ANOVA was performed on the natural log-transformed Cmax value. The ANOVA model included treatment, sequence, and period as fixed effects and subject nested within sequence as a random effect.||114.9|93.1|
72474847|NCT02236988|144474668|OTHER||Ratio of Adjusted Geometric Means|81.5|||||TWO_SIDED|90.0|75.2|88.3|||||Ratio of adjusted geometric means (Apremilast Modified Release 11 / Apremilast Immediate Release) expressed as a percentage.|To compare each test formulation with the reference formulation in each group, an ANOVA was performed on the natural log-transformed AUC0-t value. The ANOVA model included treatment, sequence, and period as fixed effects and subject nested within sequence as a random effect.||88.3|75.2|
72474848|NCT02236988|144474668|OTHER||Ratio of Adjusted Geometric Means|82.4|||||TWO_SIDED|90.0|75.9|89.5|||||Ratio of adjusted geometric means (Apremilast Modified Release 12 / Apremilast Immediate Release) expressed as a percentage.|To compare each test formulation with the reference formulation in each group, an ANOVA was performed on the natural log-transformed AUC0-t value. The ANOVA model included treatment, sequence, and period as fixed effects and subject nested within sequence as a random effect.||89.5|75.9|
72474849|NCT02236988|144474668|OTHER||Ratio of Adjusted Geometric Means|68.2|||||TWO_SIDED|90.0|62.9|74.0|||||Ratio of adjusted geometric means (Apremilast Modified Release 13 / Apremilast Immediate Release) expressed as a percentage.|To compare each test formulation with the reference formulation in each group, an ANOVA was performed on the natural log-transformed AUC0-t value. The ANOVA model included treatment, sequence, and period as fixed effects and subject nested within sequence as a random effect.||74.0|62.9|
72474850|NCT02236988|144474668|OTHER||Ratio of Adjusted Geometric Means|77.4|||||TWO_SIDED|90.0|71.3|84.0|||||Ratio of adjusted geometric means (Apremilast Modified Release 14 / Apremilast Immediate Release) expressed as a percentage.|To compare each test formulation with the reference formulation in each group, an ANOVA was performed on the natural log-transformed AUC0-t value. The ANOVA model included treatment, sequence, and period as fixed effects and subject nested within sequence as a random effect.||84.0|71.3|
72474851|NCT02236988|144474669|OTHER||Ratio of Adjusted Geometric Means|81.9|||||TWO_SIDED|90.0|75.6|88.6|||||Ratio of adjusted geometric means (Apremilast Modified Release 11 / Apremilast Immediate Release) expressed as a percentage.|To compare each test formulation with the reference formulation in each group, an ANOVA was performed on the natural log-transformed AUC0-∞ value. The ANOVA model included treatment, sequence, and period as fixed effects and subject nested within sequence as a random effect.||88.6|75.6|
72474852|NCT02236988|144474669|OTHER||Ratio of Adjusted Geometric Means|83.0|||||TWO_SIDED|90.0|76.5|90.1|||||Ratio of adjusted geometric means (Apremilast Modified Release 12 / Apremilast Immediate Release) expressed as a percentage.|To compare each test formulation with the reference formulation in each group, an ANOVA was performed on the natural log-transformed AUC0-∞ value. The ANOVA model included treatment, sequence, and period as fixed effects and subject nested within sequence as a random effect.||90.1|76.5|
72474853|NCT02236988|144474669|OTHER||Ratio of Adjusted Geometric Means|68.8|||||TWO_SIDED|90.0|63.4|74.5|||||Ratio of adjusted geometric means (Apremilast Modified Release 13 / Apremilast Immediate Release) expressed as a percentage.|To compare each test formulation with the reference formulation in each group, an ANOVA was performed on the natural log-transformed AUC0-∞ value. The ANOVA model included treatment, sequence, and period as fixed effects and subject nested within sequence as a random effect.||74.5|63.4|
72474854|NCT02236988|144474669|OTHER||Ratio of Adjusted Geometric Means|77.8|||||TWO_SIDED|90.0|71.8|84.4|||||Ratio of adjusted geometric means (Apremilast Modified Release 14 / Apremilast Immediate Release) expressed as a percentage.|To compare each test formulation with the reference formulation in each group, an ANOVA was performed on the natural log-transformed AUC0-∞ value. The ANOVA model included treatment, sequence, and period as fixed effects and subject nested within sequence as a random effect.||84.4|71.8|
72474855|NCT02236988|144474670|OTHER||Median Difference|0.98||||0.0523|TWO_SIDED|90.0|0.03|1.5|||Wilcoxon signed-rank test||Median difference (Apremilast Modified Release 11 - Apremilast Immediate Release) calculated from the Hodges-Lehmann estimate.|Tmax was analyzed by nonparametric methods. The median difference and 90% CI of the median difference were calculated from the Hodges-Lehrmann estimate.||1.50|0.03|0.0523
72474856|NCT02236988|144474670|OTHER||Median Difference|0.5||||0.2598|TWO_SIDED|90.0|0.0|1.0|||Wilcoxon signed-rank test||Median difference (Apremilast Modified Release 12 - Apremilast Immediate Release) calculated from the Hodges-Lehmann estimate.|Tmax was analyzed by nonparametric methods. The median difference and 90% CI of the median difference were calculated from the Hodges-Lehrmann estimate.||1.00|0.00|0.2598
72474857|NCT02236988|144474670|OTHER||Median Difference|1.5||||0.0053|TWO_SIDED|90.0|1.0|3.0|||Wilcoxon signed-rank test||Median difference (Apremilast Modified Release 13 - Apremilast Immediate Release) calculated from the Hodges-Lehmann estimate.|Tmax was analyzed by nonparametric methods. The median difference and 90% CI of the median difference were calculated from the Hodges-Lehrmann estimate.||3.00|1.00|0.0053
72507299|NCT03151148|144546504|SUPERIORITY||Geometric mean ratio (GMR)|2.43||||0.042|TWO_SIDED|95.0|1.031|5.724|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator.|"TMT vs Placebo on Non-lesional Skin at Day 11~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||5.724|1.031|0.042
72507300|NCT00494871|144546505|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin of 2.0|Hazard Ratio (HR)|1.11||||0.025|TWO_SIDED|95.0|0.87|1.42|||Regression, Cox|||||1.42|0.87|0.025
72507301|NCT00494871|144546506|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.49|||||TWO_SIDED|95.0|0.24|1.0||||||||1.00|0.24|
72507302|NCT00494871|144546507|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.65|||||TWO_SIDED|95.0|0.34|1.22||||||||1.22|0.34|
72507303|NCT00494871|144546508|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.74|||||TWO_SIDED|95.0|0.41|1.34||||||||1.34|0.41|
72507304|NCT00494871|144546509|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.46|||||TWO_SIDED|95.0|0.22|0.98||||||||0.98|0.22|
72507305|NCT00494871|144546510|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.99|||||TWO_SIDED|95.0|0.06|15.85||||||||15.85|0.06|
72507306|NCT00494871|144546511|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.93|||||TWO_SIDED|95.0|0.3|28.16||||||||28.16|0.30|
72507307|NCT00494871|144546512|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.97|||||TWO_SIDED|95.0|0.6|14.7||||||||14.70|0.60|
72507308|NCT00494871|144546513|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.48|||||TWO_SIDED|95.0|0.16|1.4||||||||1.40|0.16|
72507309|NCT00494871|144546514|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.37|||||TWO_SIDED|95.0|0.43|4.31||||||||4.31|0.43|
72507310|NCT00494871|144546515|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.85|||||TWO_SIDED|95.0|0.5|1.43||||||||1.43|0.50|
72507311|NCT00494871|144546516|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.2|||||TWO_SIDED|95.0|0.92|1.56||||||||1.56|0.92|
72576828|NCT00261443|144680657|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.19||||0.132|TWO_SIDED|95.0|-0.43|0.06||Baseline: ANOVA model, controlling for treatment, mood stabilizer, and index mood episode. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 40 Comparison||0.06|-0.43|0.132
72507312|NCT02433210|144546543|SUPERIORITY||||||<|0.001||||||The p value was not adjusted for multiple comparisons and the difference was considered significant at the p\<0.05 level.|t-test, 2 sided|Shapiro-Wilk test for Normality and equal variance was used. If data failed either non-parametric Mann-Whitney Rank sum test was used.||Session 1 clearance beta 2 microglobilin Optiflux vs Revaclear.||||<0.001
72507313|NCT02433210|144546543|SUPERIORITY||||||<|0.001||||||The p value is not adjusted for multiple comparisons and a p\<0.05 is considered significant.|t-test, 2 sided|Shapiro-Wilk test for Normality and equal variance was used. If data failed either non-parametric Mann-Whitney Rank sum test was used.||Session 1 Clearance beta 2 microglobulin Optiflux vs ELISIO.||||<0.001
72507314|NCT02433210|144546543|SUPERIORITY||||||=|0.178||||||The p value was not adjusted for multiple comparisons and the difference was considered significant at the p\<0.05 level.|t-test, 2 sided|Shapiro-Wilk test for Normality and equal variance was used. If data failed either non-parametric Mann-Whitney Rank sum test was used.||Session 1 clearance beta 2 microglobulin Revaclear vs ELISIO..||||=0.178
72507315|NCT02433210|144546543|SUPERIORITY||||||=|0.016||||||The p value was not adjusted for multiple comparisons and the difference was considered significant at the p\<0.05 level.|Wilcoxon (Mann-Whitney)|Shapiro-Wilk test for Normality and equal variance was used. If data failed either non-parametric Mann-Whitney Rank sum test was used.||Session 1 Clearance of myoglobin Optiflux vs Revaclear.||||=0.016
72507316|NCT02433210|144546543|SUPERIORITY||||||=|0.033||||||The p value was not adjusted for multiple comparisons and the difference was considered significant at the p\<0.05 level.|t-test, 2 sided|Shapiro-Wilk test for Normality and equal variance was used. If data failed either non-parametric Mann-Whitney Rank sum test was used.||Session 1 Clearance of myoglobin Optiflux vs ELISIO.||||=0.033
72507317|NCT02433210|144546543|SUPERIORITY||||||=|0.935|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and equal variance was used. If data failed either non-parametric Mann-Whitney Rank sum test was used.||Session 1 Clearance of myoglobin Revaclear vs ELISIO.||||=0.935
72507318|NCT02433210|144546543|SUPERIORITY||||||=|0.463|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and equal variance was used. If data failed either non-parametric Mann-Whitney Rank sum test was used.||Session 2 Clearance of urea nitrogen Optiflux vs Revaclaer.||||=0.463
72507319|NCT02433210|144546543|SUPERIORITY||||||=|0.392|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and equal variance was used. If data failed either non-parametric Mann-Whitney Rank sum test was used.||Session 2 Clearance of urea nitrogen Optiflux vs ELISIO.||||=0.392
72507320|NCT02433210|144546543|SUPERIORITY||||||=|0.597|||||||Wilcoxon (Mann-Whitney)|Shapiro-Wilk test for Normality and equal variance was used. If data failed either non-parametric Mann-Whitney Rank sum test was used.||Session 2 Clearance urea nitrogen Revaclear vs ELISIO.||||=0.597
72507321|NCT02433210|144546543|SUPERIORITY||||||=|0.162|||||||Wilcoxon (Mann-Whitney)|Shapiro-Wilk test for Normality and equal variance was used. If data failed either non-parametric Mann-Whitney Rank sum test was used.||Session 2 Clearance of creatinine Optiflux vs Revaclear.||||=0.162
72507322|NCT02433210|144546543|SUPERIORITY|||||||0.186|||||||Wilcoxon (Mann-Whitney)|Shapiro-Wilk test for Normality and equal variance was used. If data failed either non-parametric Mann-Whitney Rank sum test was used.||Session 2 Clearance of creatinine Optiflux vs ELISIO.||||0.186
72474858|NCT02236988|144474670|OTHER||Median Difference|0.5||||0.1093|TWO_SIDED|90.0|0.0|1.0|||Wilcoxon signed-rank test||Median difference (Apremilast Modified Release 14 - Apremilast Immediate Release) calculated from the Hodges-Lehmann estimate.|Tmax was analyzed by nonparametric methods. The median difference and 90% CI of the median difference were calculated from the Hodges-Lehrmann estimate.||1.00|0.00|0.1093
72474859|NCT04032613|144474679|OTHER|Paired sample t-test||||||0.2||||||Statistically significant p-value is \<0.05|Paired sample t-test|||||||0.20
72474860|NCT04032613|144474680|OTHER|Paired sample t-test||||||0.05||||||Statistically significant p-value is \<0.05|Paired sample t-test|||||||0.05
72474861|NCT04032613|144474681|OTHER|Paired sample t-test||||||0.004||||||Statistically significant p-value is \<0.05|Paired sample t-test|||||||0.004
72474862|NCT04032613|144474682|OTHER|Paired sample t-test||||||0.14||||||Statistically significant p-value is \<0.05|Paired sample t-test|||||||0.14
72474863|NCT02071290|144474686|SUPERIORITY|||||||0.56|||||||Mixed Models Analysis|||||||0.56
72474864|NCT02071290|144474687|SUPERIORITY|||||||0.287|||||||Mixed Models Analysis|||||||0.287
72474865|NCT02071290|144474688|SUPERIORITY|||||||0.597|||||||Mixed Models Analysis|||||||0.597
72507323|NCT02433210|144546543|SUPERIORITY|No Significant difference.||||||0.624|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and equal variance was used. If data failed either non-parametric Mann-Whitney Rank sum test was used.||Session 1 Urea nitrogen clearance Optiflux vs Revaclear.||||0.624
72507324|NCT02433210|144546543|SUPERIORITY|||||||0.732|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and equal variance was used. If data failed either non-parametric Mann-Whitney Rank sum test was used.||Session 1 Urea nitrogen clearance Optiflux vs ELISIO.||||0.732
72566088|NCT03135899|144662926|OTHER||Geometric Mean Ratio|0.845|STANDARD_ERROR_OF_MEAN|1.169|||TWO_SIDED|90.0|0.651|1.095|||Mixed Models Analysis||BI 443651 1200 μg is compared to placebo. Standard error of the mean is actually geometric standard error.|The mixed effects model included 'treatment' and 'period' as fixed effects, 'patient' as a random effect, and 'period baseline' as well as 'patient baseline' as covariates. No hypothesis was tested. The patient baseline was obtained by calculating the mean of the period baselines for each patient. Covariance structure variance component (VC) was used for random subject effect.||1.095|0.651|
72566089|NCT03135899|144662928|OTHER||Hazard Ratio (HR)|2.27|||||TWO_SIDED|95.0|1.31|3.95|||Regression, Cox||BI 443651 100 μg is compared to placebo.|The cox proportional hazard model included treatment and period as fixed effect and patient baseline as covariate. No hypothesis was tested. The patient baseline was obtained by calculating the median of the period baselines for each patient. A hazard ratio greater than 1 gives that active treatment is not-inferior to placebo.||3.95|1.31|
72474866|NCT02071290|144474689|SUPERIORITY|||||||0.307|||||||Mixed Models Analysis|||||||0.307
72474867|NCT02071290|144474690|SUPERIORITY|||||||0.646|||||||Mixed Models Analysis|||||||0.646
72566090|NCT03135899|144662928|OTHER||Hazard Ratio (HR)|2.08|||||TWO_SIDED|95.0|1.22|3.53|||Regression, Cox||BI 443651 400 μg is compared to placebo.|The cox proportional hazard model included treatment and period as fixed effect and patient baseline as covariate. No hypothesis was tested. The patient baseline was obtained by calculating the median of the period baselines for each patient. A hazard ratio greater than 1 gives that active treatment is not-inferior to placebo.||3.53|1.22|
72398411|NCT00546637|144303184|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.3|STANDARD_ERROR_OF_MEAN|0.9||0.7685||95.0|-1.6|2.1||P-value was based on ANCOVA model with terms for country, treatment, and baseline value as covariate. No adjustment of p-value was made for multiple comparisons.|ANCOVA||Mean Difference (net) = Least squares mean|Week 12||2.1|-1.6|0.7685
72474868|NCT02071290|144474691|SUPERIORITY|||||||0.757|||||||Mixed Models Analysis|||||||0.757
72474869|NCT02071290|144474692|SUPERIORITY|||||||0.075|||||||Mixed Models Analysis|||||||0.075
72474870|NCT02071290|144474693|SUPERIORITY|||||||0.967|||||||Mixed Models Analysis|||||||0.967
72474871|NCT02071290|144474694|SUPERIORITY|||||||0.637|||||||Mixed Models Analysis|||||||0.637
72474872|NCT02071290|144474695|SUPERIORITY|||||||0.664|||||||Mixed Models Analysis|||||||0.664
72474873|NCT02071290|144474696|SUPERIORITY|||||||0.661|||||||Mixed Models Analysis|||||||0.661
72474874|NCT02071290|144474697|SUPERIORITY|||||||0.916|||||||Mixed Models Analysis|||||||0.916
72474875|NCT02071290|144474698|SUPERIORITY|||||||0.437|||||||Mixed Models Analysis|||||||0.437
72474876|NCT02071290|144474699|SUPERIORITY|||||||0.353|||||||Mixed Models Analysis|||||||0.353
72474877|NCT02071290|144474700|SUPERIORITY|||||||0.99|||||||Mixed Models Analysis|||||||0.99
72474878|NCT02071290|144474701|SUPERIORITY|||||||0.085|||||||Mixed Models Analysis|||||||0.085
72474879|NCT02071290|144474702|SUPERIORITY|||||||0.371|||||||Mixed Models Analysis|||||||0.371
72474880|NCT02071290|144474703|SUPERIORITY|||||||0.106|||||||Mixed Models Analysis|||||||0.106
72474881|NCT02071290|144474704|SUPERIORITY|||||||0.829|||||||Mixed Models Analysis|||||||0.829
72474882|NCT02071290|144474705|SUPERIORITY|||||||0.323|||||||Wilcoxon (Mann-Whitney)|||||||0.323
72474883|NCT02071290|144474706|SUPERIORITY|||||||0.287|||||||Wilcoxon (Mann-Whitney)|||||||0.287
72474884|NCT02071290|144474707|SUPERIORITY|||||||0.151|||||||Wilcoxon (Mann-Whitney)|||||||0.151
72474885|NCT02071290|144474708|SUPERIORITY|||||||0.51|||||||Chi-squared|||||||0.510
72474886|NCT02071290|144474709|SUPERIORITY|||||||0.348|||||||Chi-squared|||||||0.348
72474887|NCT02071290|144474710|SUPERIORITY|||||||0.911|||||||Chi-squared|||||||0.911
72474888|NCT01072630|144474723|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.1||||0.1302|TWO_SIDED|95.0|-4.67|0.6||All statistical tests were 2-tailed at the 0.05 level of significance.|mixed-model repeated measures (MMRM)|Treatment, visit, treatment-by-visit interaction, concurrent mood-stabilizing medication, and region of the world used as fixed factors.||||0.60|-4.67|0.1302
72507325|NCT02433210|144546543|SUPERIORITY|||||||0.427|||||||Wilcoxon (Mann-Whitney)|Shapiro-Wilk test for Normality and equal variance was used. If data failed either non-parametric Mann-Whitney Rank sum test was used.||Session 1 Urea Nitrogen clearance Revaclear vs Optiflux.||||0.427
72507326|NCT02433210|144546543|SUPERIORITY|||||||0.379|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and equal variance was used. If data failed either non-parametric Mann-Whitney Rank sum test was used.||Session 1 Creatinine clearance Optiflux vs Revaclear..||||0.379
72507327|NCT02433210|144546543|SUPERIORITY|||||||0.318|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and equal variance was used. If data failed either non-parametric Mann-Whitney Rank sum test was used.||Session 1 Creatinine clearance Optiflux vs ELISIO.||||0.318
72474889|NCT01072630|144474723|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.9||||0.135|TWO_SIDED|95.0|-4.51|0.61||All statistical tests were 2-tailed at the 0.05 level of significance.|mixed-model repeated measures (MMRM)|Treatment, visit, treatment-by-visit interaction, concurrent mood-stabilizing medication, and region of the world used as fixed factors.||||0.61|-4.51|0.1350
72474890|NCT01232738|144474746|SUPERIORITY||Mean Difference (Final Values)|-0.25||||0.07|TWO_SIDED|95.0|-0.53|0.02|||Chi-squared|||Difference in slope of decline||0.02|-0.53|0.07
72474891|NCT01232738|144474747|SUPERIORITY|||||||0.58|||||||Log Rank|||||||0.58
72474892|NCT03547739|144474769|SUPERIORITY||Risk Ratio (RR)|4.22|||<|0.001|TWO_SIDED|95.0|2.88|6.18|||Chi-squared||Generalized Estimating Equation model with robust standard errors used. Risk Ratios reported were adjusted for baseline education level, wealth index, length of couple relationship, previous couple testing at baseline, and couple age disparity.|Home visits as compared to Standard Care||6.18|2.88|<0.001
72474893|NCT03547739|144474769|SUPERIORITY||Risk Ratio (RR)|3.69|||<|0.001|TWO_SIDED|95.0|2.5|5.45|||Chi-squared||Generalized Estimating Equation model with robust standard errors used. Risk Ratios reported were adjusted for baseline education level, wealth index, length of couple relationship, previous couple testing at baseline, and couple age disparity.|HIV Self-testing as compared to Standard Care||5.45|2.50|<0.001
72474894|NCT03547739|144474770|SUPERIORITY||Risk Ratio (RR)|1.21||||0.001|TWO_SIDED|95.0|1.12|1.31|||Chi-squared||Generalized Estimating Equation model with robust standard errors used. Risk Ratios reported were adjusted for baseline education level, wealth index, length of couple relationship, previous couple testing at baseline, and and couple age disparity.|Comparison of the Home Visit arm with Standard Care||1.31|1.12|.001
72474895|NCT03547739|144474770|SUPERIORITY||Risk Ratio (RR)|1.26||||0.001|TWO_SIDED|95.0|1.17|1.36|||Chi-squared||Generalized Estimating Equation model with robust standard errors used. Risk Ratios reported were adjusted for baseline education level, wealth index, length of couple relationship, previous couple testing at baseline, and and couple age disparity.|Comparison of HIVST arm with Standard Care arm||1.36|1.17|.001
72474896|NCT03547739|144474784|SUPERIORITY||Risk Ratio (RR)|1.08||||0.011|TWO_SIDED|95.0|1.03|1.12|||Chi-squared||Generalized Estimating Equation model (binomial family and log link) with robust standard errors used. Risk Ratios reported were adjusted for baseline education level, wealth, length of couple relationship, and couple age disparity.|Comparison of the Home Visit arm with Standard Care||1.12|1.03|.011
72507328|NCT02433210|144546543|SUPERIORITY||||||=|0.914|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and equal variance was used. If data failed either non-parametric Mann-Whitney Rank sum test was used.||Session 1 Creatinine clearance Revaclear vs ELISIO.||||=0.914
72507329|NCT02433210|144546543|SUPERIORITY||||||=|0.623|||||||Wilcoxon (Mann-Whitney)|Shapiro-Wilk test for Normality and equal variance was used. If data failed either non-parametric Mann-Whitney Rank sum test was used.||Session 1 Phosphate clearance Optiflux vs Revaclear.||||=0.623
72507330|NCT02433210|144546543|SUPERIORITY||||||=|0.403|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and equal variance was used. If data failed either non-parametric Mann-Whitney Rank sum test was used.||Session 1 Phosphate clearance Optiflux vs ELISIO.||||=0.403
72507331|NCT02433210|144546543|SUPERIORITY||||||=|0.85|||||||Wilcoxon (Mann-Whitney)|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||Session 1 Phosphate clearance Revaclear vs ELISIO.||||=0.850
72507332|NCT02433210|144546543|SUPERIORITY||||||=|0.815|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||Session 2 Clearance of creatinine Revaclear vs ELISIO.||||=0.815
72474897|NCT03547739|144474784|SUPERIORITY||Risk Ratio (RR)|1.02||||0.011|TWO_SIDED|95.0|0.97|1.08|||Chi-squared||Generalized Estimating Equation model (binomial family and log link) with robust standard errors used. Risk Ratios reported were adjusted for baseline education level, wealth, length of couple relationship, and couple age disparity.|Comparison of the HIVST arm with Standard Care||1.08|0.97|0.011
72474898|NCT03547739|144474785|OTHER||Kaplan Meier estimates|0.92||||0.087|TWO_SIDED|95.0|0.86|0.95|||Log Rank|||||0.95|0.86|0.087
72474899|NCT03547739|144474785|OTHER||Kaplan Meier estimates|0.96||||0.087|TWO_SIDED|95.0|0.91|0.98|||Log Rank|||||0.98|0.91|0.087
72474900|NCT03547739|144474785|OTHER||Kaplan Meier estimates|0.98||||0.087|TWO_SIDED|95.0|0.93|0.99|||Log Rank|||||0.99|0.93|0.087
72474901|NCT02770612|144474843|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||We used a one sided one sample Wilcoxon test to compare the median number of oxycodone tablets chosen and prescribed to the institutional standard of 40 tablets of oxycodone 5mg on discharge||||<0.001
72474902|NCT02003222|144474844|SUPERIORITY||Hazard Ratio (HR)|0.44||||0.003|TWO_SIDED|95.0|0.25|0.76|||Log Rank||hazard ratio: blinatumomab + chemotherapy vs. chemotherapy alone|||0.76|0.25|0.003
72474903|NCT02003222|144474845|SUPERIORITY||Hazard Ratio (HR)|0.53||||0.015|TWO_SIDED|95.0|0.31|0.89|||Log Rank||hazard ratio: Blinatumomab + Chemotherapy vs. Chemotherapy alone|||0.89|0.31|0.015
72474904|NCT02003222|144474846|SUPERIORITY||Hazard Ratio (HR)|0.77||||0.67|TWO_SIDED|95.0|0.22|2.65|||Log Rank|||||2.65|0.22|0.67
72474905|NCT02003222|144474847|SUPERIORITY||Hazard Ratio (HR)|1.0||||1|TWO_SIDED|95.0|0.28|3.63|||Log Rank|||||3.63|0.28|1.00
72507333|NCT02433210|144546543|SUPERIORITY||||||=|0.367|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||Session 2 Clearance of Phosphate Optiflux vs Revaclear.||||=0.367
72507334|NCT02433210|144546543|SUPERIORITY||||||=|0.821|||||||Wilcoxon (Mann-Whitney)|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||Session 2 Clearance of phosphate Optiflux vs Elisio.||||=0.821
72507335|NCT02433210|144546543|SUPERIORITY||||||=|0.364|||||||Wilcoxon (Mann-Whitney)|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||Session 2 Clearance phosphate Revaclear vs ELISIO.||||=0.364
72507336|NCT02433210|144546543|SUPERIORITY||||||<|0.001||||||The p value was not adjusted for multiple comparisons and the difference was considered significant at the p\<0.05 level.|t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||Session 2 Clearance of beta 2 microglobulin Optiflux vs Revaclear.||||<0.001
72623099|NCT04101331|144776615|OTHER|||||||0.112||||||One-sided p-value.|Exact binomial test|Exact binomial test compares versus a proportion of 0.25.||||||0.112
72474906|NCT02003222|144474848|SUPERIORITY||Hazard Ratio (HR)|0.59||||0.41|TWO_SIDED|95.0|0.17|2.11|||Log Rank||hazard ratio: blinatumomab + chemotherapy vs. chemotherapy alone|||2.11|0.17|0.41
72474907|NCT02369068|144474859|OTHER|||||||0.072|||||||Kruskal-Wallis|This test was selected since the distribution of the change in pain was not normal nor approximately symmetric.||The null hypothesis assumed there were no differences in the pain score change between groups. Significance level was set at 0.05.||||0.072
72474908|NCT02369068|144474860|OTHER|||||||0.624|||||||Kruskal-Wallis|||The null hypothesis assumed there were no differences in the median change pain severity between the groups. Significance level was set at 0.05||||0.624
72474909|NCT02369068|144474861|OTHER|||||||0.571|||||||Kruskal-Wallis|||The null hypothesis assumed that there is no difference in the change in pain interference between the groups. Statistical significance was set at 0.05||||0.571
72474910|NCT02369068|144474862|OTHER|||||||0.285|||||||Kruskal-Wallis|||The null hypothesis assumed that there was no difference in the distribution between the groups. Significance level was set at 0.05||||0.285
72474911|NCT01989169|144474955|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|If the 90% CI of the geometric mean ratios were within the range (0.80, 1.25), then equivalence was assumed and the hypothesis that a drug interaction occurred was rejected. If the 90% CIs were not wholly contained within the range (0.80, 1.25), then a drug interaction was not excluded.|Ratio of Geometric LS Means|1.215|||||TWO_SIDED|90.0|1.116|1.323|||Mixed-effects Model||The ratio of geometric LS means and 90% CIs for the geometric mean ratio is for Treatment B to Treatment A.|The means of the log-transformed pharmacokinetic parameters were compared between treatments using a mixed-effects model with period and treatment as fixed effects and subject nested within sequence as a random effect. In order to estimate the magnitude of the treatment regimen differences in AUCinf, the geometric mean ratio (i.e., the least squares mean difference in the log-transformed parameters back transformed to the original scale) and their 90% CIs were calculated.||1.323|1.116|
72474912|NCT01989169|144474956|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|If the 90% CI of the geometric mean ratios fell within the range (0.80, 1.25), then equivalence was assumed and the hypothesis that a drug interaction occurred was rejected. If the 90% CIs were not wholly contained within the range (0.80, 1.25), then a drug interaction was not excluded.|Ratio of Geometric LS Means|1.216|||||TWO_SIDED|90.0|1.115|1.327|||Mixed-effects Model||The ratio of geometric LS means and 90% CIs for the geometric mean ratio is for Treatment B to Treatment A.|The means of the log-transformed pharmacokinetic parameters were compared between treatments using a mixed-effects model with period and treatment as fixed effects, and subject nested within sequence as a random effect. In order to estimate the magnitude of the treatment regimen differences in AUClast, the geometric mean ratio (i.e., the least squares mean difference in the log-transformed parameters back transformed to the original scale) and their 90% CIs were calculated.||1.327|1.115|
72474913|NCT01989169|144474957|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|If the 90% CI of the geometric mean ratios fell within the range (0.80, 1.25), then equivalence was assumed and the hypothesis that a drug interaction occurred was rejected. If the 90% CIs were not wholly contained within the range (0.80, 1.25), then a drug interaction was not excluded.|Ratio of Geometric LS Means|1.383|||||TWO_SIDED|90.0|1.282|1.491|||Mixed-effects Model||The ratio of geometric LS means and 90% CIs for the geometric mean ratio is for Treatment B to Treatment A.|The means of the log-transformed pharmacokinetic parameters were compared between treatments using a mixed-effects model with period and treatment as fixed effects, and subject nested within sequence as a random effect. In order to estimate the magnitude of the treatment regimen differences in Cmax, the geometric mean ratio (i.e., the least squares mean difference in the log-transformed parameters back transformed to the original scale) and their 90% CIs were calculated.||1.491|1.282|
72474914|NCT02406677|144474958|SUPERIORITY||Hazard Ratio (HR)|1.073||||0.3503|TWO_SIDED|95.0|0.925|1.246|||Regression, Cox|Cox proportional hazards model accounting for within hospital clustering using robust standard errors|Usual Care arm is the reference group|||1.246|0.925|0.3503
72566091|NCT03135899|144662928|OTHER||Hazard Ratio (HR)|2.59|||||TWO_SIDED|95.0|1.5|4.47|||Regression, Cox||BI 443651 1200 μg is compared to placebo.|The cox proportional hazard model included treatment and period as fixed effect and patient baseline as covariate. No hypothesis was tested. The patient baseline was obtained by calculating the median of the period baselines for each patient. A hazard ratio greater than 1 gives that active treatment is not-inferior to placebo.||4.47|1.50|
72566092|NCT04146363|144662929|SUPERIORITY||Risk Difference (RD)|29.7|||<|1e-06|TWO_SIDED|95.0|21.6|37.8|||Cochran-Mantel-Haenszel|||||37.8|21.6|<0.000001
72566093|NCT04146363|144662930|SUPERIORITY||Risk Difference (RD)|42.0|||<|1e-06|TWO_SIDED|95.0|33.3|50.6|||Cochran-Mantel-Haenszel|||||50.6|33.3|<0.000001
72474915|NCT02406677|144474959|SUPERIORITY||Odds Ratio (OR)|0.838||||0.026|TWO_SIDED|95.0|0.717|0.979|||Regression, Logistic|Logistic regression model with parameters estimated using GEE to account for within hospital clustering for selected patient characteristics||||0.979|0.717|0.0260
72474916|NCT02406677|144474960|SUPERIORITY||Odds Ratio (OR)|2.035|||<|0.0001|TWO_SIDED|95.0|1.564|2.649|||Regression, Logistic|Logistic regression with GEE to account for within hospital clustering||||2.649|1.564|<0.0001
72474917|NCT05384938|144474993|OTHER|Single group|Median time to response|100.0|||||TWO_SIDED|95.0|65.0|160.0|||||Estimate for Time to Response using Kaplan-Meier method|Estimate for Time to Response (Days)||160.0|65.00|
72474918|NCT05384938|144474997|OTHER|Parametric Test|||||<|0.0001|||||||paired t-test|||Week 4 (Visit 2)||||<0.0001
72474919|NCT05384938|144474997|OTHER|Parametric Test|||||<|0.0001|||||||paired t-test|||Week 16 (Visit 4)||||<0.0001
72474920|NCT05384938|144474997|OTHER|Parametric Test|||||<|0.0001|||||||paired t-test|||Week 24 (Visit 5)||||<0.0001
72474921|NCT00128102|144475064|SUPERIORITY||Hazard Ratio (HR)|0.98||||0.858|TWO_SIDED|95.0|0.83|1.17|||Log Rank|||||1.17|0.83|0.858
72474922|NCT00128102|144475068|SUPERIORITY||Hazard Ratio (HR)|0.75|||<|0.001|TWO_SIDED|95.0|0.63|0.88|||Likelihood Based Score Test|||||0.88|0.63|<0.001
72474923|NCT00128102|144475069|SUPERIORITY||Difference in Percentage|0.3||||0.621|TWO_SIDED|95.0|-1.18|1.97|||Fisher Exact|||||1.97|-1.18|0.621
72474924|NCT00128102|144475070|SUPERIORITY||Difference in Percent Change|-52.4||||0.259|TWO_SIDED|95.0|-143.5|38.6|||Longitudinal Model|||||38.6|-143.5|0.259
72474925|NCT00128102|144475071|SUPERIORITY||Difference in Percentage|-1.3||||0.736|TWO_SIDED|95.0|-7.2|4.53|||Fisher Exact|||||4.53|-7.20|0.736
72474926|NCT00128102|144475072|SUPERIORITY||Difference in Percent Change|-0.06||||0.979|TWO_SIDED|95.0|-4.61|4.49|||Longitudinal Model|||||4.49|-4.61|0.979
72474927|NCT00128102|144475073|SUPERIORITY||Difference in Percentage|3.1||||0.488|TWO_SIDED|95.0|-4.97|11.17|||Fisher Exact|||||11.17|-4.97|0.488
72474928|NCT04143945|144475089|OTHER|Comparison|Estimated treatment difference|2.6||||0.0395|TWO_SIDED|95.0|0.1|5.1|||ANOVA|||The intensity of pain was analysed by a fixed analysis of variance model with VAS pain score as the dependent variable, and product, injection side (right side, left side), injection number (first injection, second injection), and participant as fixed effects.||5.1|0.1|0.0395
72474929|NCT00503139|144475108|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 1 sample|A two-sided t-test was performed to test the hypothesis.||The null hypothesis was that mHAQ scores at 6 months, 1 year, 1.5 years, and 2 years were equal to the baseline score.||||<0.001
72474930|NCT00503139|144475109|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 1 sample|A two-sided t-test was performed to test the hypothesis.||The null hypothesis was that VAS Fatigue scores at 6 months, 1 year, 1.5 years, and 2 years were equal to the baseline score.||||<0.001
72474931|NCT00833833|144475113|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.73|||||TWO_SIDED|95.0|0.54|0.99||||||With a 12-month accrual period and 12-month follow-up after the study closed to accrual, assuming a 10% drop out rate, 96 participants in each treatment arm would have had 85% power to detect a hazard rate ratio of 1.67 using a one-sided log rank test with an overall significance level of 0.025 adjusted for one interim analysis) and a significance level of 0.0245 for the final analysis.||0.99|0.54|
72474932|NCT00833833|144475118|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|6.25|||||TWO_SIDED|95.0|0.84|46.66||||||||46.66|0.84|
72474933|NCT00833833|144475119|SUPERIORITY_OR_OTHER|||||||0.07||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.070
72474934|NCT00833833|144475120|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.85|||||TWO_SIDED|95.0|0.57|1.29||||||||1.29|0.57|
72474935|NCT01262677|144475154|SUPERIORITY||Mean Difference|-0.99||||0.9076|TWO_SIDED|95.0|-16.28|17.11||Statistical testing was done at 95% confidence intervals, two-sided, least square means and their standard errors.|ANCOVA||Value is percent reduction in seizures relative to placebo.|ANCOVA model with the following fixed terms was used to calculate the p-value: loge (baseline 28-day seizure rate + 1) as a coninuous covariate, sites pooled by geographic region (ie, U.S., Europe, Asia, rest of the world), and treatment group (placebo, pregabalin 165 mg controlled-release (CR), pregabalin 330 mg CR). 88 participants in each group (264 total) should have provided approximately 90% power.||17.11|-16.28|0.9076
72474936|NCT01262677|144475154|SUPERIORITY||Mean Difference|-13.05||||0.0907|TWO_SIDED|95.0|-26.07|2.25||Statistical testing was done at 95% confidence intervals, two-sided, least square means and their standard errors.|ANCOVA||Value is percent reduction in seizures relative to placebo.|ANCOVA model with the following fixed terms was used to calculate the p-value: loge (baseline 28-day seizure rate + 1) as a coninuous covariate, sites pooled by geographic region (ie, U.S., Europe, Asia, rest of the world), and treatment group (placebo, pregabalin 165 mg controlled-release (CR), pregabalin 330 mg CR). 88 participants in each group (264 total) should have provided approximately 90% power.||2.25|-26.07|0.0907
72474937|NCT01262677|144475155|SUPERIORITY|||||||0.752||||||Statistical testing was done at alpha = 0.05 level, two-sided.|Cochran-Mantel-Haenszel|||A 2-sided Cochran-Mantel-Haenszel test stratified by geographical region (U.S., Europe, Asia, or Rest of the World) was used to calculate the p-value. No adjustments for multiplicity were taken.||||0.752
72474938|NCT01262677|144475155|SUPERIORITY|||||||0.125||||||Statistical testing was done at alpha = 0.05 level, two-sided.|Cochran-Mantel-Haenszel|||A 2-sided Cochran-Mantel-Haenszel test stratified by geographical region (U.S., Europe, Asia, or Rest of the World) was used to calculate the p-value. No adjustments for multiplicity were taken.||||0.125
72474939|NCT01262677|144475156|SUPERIORITY||LS Mean Difference|-9.3||||0.5404|TWO_SIDED|95.0|-39.16|20.56||Statistical testing was done at alpha = 0.05 level, two-sided.|ANCOVA||Value is percent reduction in seizures relative to placebo.|ANCOVA model was used to calculate the p-value.||20.56|-39.16|0.5404
72474940|NCT01262677|144475156|SUPERIORITY||LS Mean Difference|-25.84||||0.0786|TWO_SIDED|95.0|-54.64|2.97||Statistical testing was done at alpha = 0.05 level, two-sided.|ANCOVA||Value is percent reduction in seizures relative to placebo.|ANCOVA model was used to calculate the p-value.||2.97|-54.64|0.0786
72474941|NCT01262677|144475157|SUPERIORITY||LS Mean Difference|-0.11||||0.6073|TWO_SIDED|95.0|-0.53|0.31||Statistical testing was done at alpha = 0.05 level, two-sided.|Generalized linear model (GLM)|||A generalized linear model accounting for treatment and geographical region as fixed effects and baseline seizure frequency as a covariate was used to calculate the p-value. This generalized linear model assumed that the SGTC seizure frequency was from a Poisson distribution with a canonical log link function.||0.31|-0.53|0.6073
72474942|NCT01262677|144475157|SUPERIORITY||LS Mean Difference|-0.16||||0.4109|TWO_SIDED|95.0|-0.53|0.22||Statistical testing was done at alpha = 0.05 level, two-sided.|GLM|||A generalized linear model accounting for treatment and geographical region as fixed effects and baseline seizure frequency as a covariate was used to calculate the p-value. This generalized linear model assumed that the SGTC seizure frequency was from a Poisson distribution with a canonical log link function.||0.22|-0.53|0.4109
72507337|NCT02433210|144546543|SUPERIORITY||||||<|0.001||||||The p value was not adjusted for multiple comparisons and the difference was considered significant at the p\<0.05 level.|t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||Session 2 Clearance of beta 2 microglobulin Optiflux vs ELISIO.||||<0.001
72474943|NCT01262677|144475158|SUPERIORITY||LS Mean Difference|-1.38||||0.8268|TWO_SIDED|95.0|-12.97|11.75||Statistical testing was done at alpha = 0.05 level, two-sided.|ANCOVA||Value is percent reduction in seizures relative to placebo.|ANCOVA model with the following fixed terms was used to calculate the p-value: loge (baseline 28-day seizure rate + 1) as a coninuous covariate, sites pooled by geographic region (ie, U.S., Europe, Asia, rest of the world), and treatment group (placebo, pregabalin 165 mg CR, pregabalin 330 mg CR).||11.75|-12.97|0.8268
72474944|NCT01262677|144475158|SUPERIORITY||LS Mean Difference|0.75||||0.9024|TWO_SIDED|95.0|-10.69|13.66||Statistical testing was done at alpha = 0.05 level, two-sided.|ANCOVA||Value is percent reduction in seizures relative to placebo.|ANCOVA model with the following fixed terms was used to calculate the p-value: loge (baseline 28-day seizure rate + 1) as a coninuous covariate, sites pooled by geographic region (ie, U.S., Europe, Asia, rest of the world), and treatment group (placebo, pregabalin 165 mg CR, pregabalin 330 mg CR).||13.66|-10.69|0.9024
72507338|NCT02433210|144546543|SUPERIORITY||||||=|0.254|||||||t-test, 2 sided|||Session 2 Clearance of beta 2 microglobulin Revaclear vs ELISIO.||||=0.254
72474945|NCT01262677|144475159|SUPERIORITY|||||||0.67||||||Statistical testing was done at alpha = 0.05 level, two-sided.|Cochran-Mantel-Haenszel|||A 2-sided Cochran-Mantel-Haenszel test stratified by geographical region (U.S., Europe, Asia, or Rest of the World) wtih percentage of responders summarized by treatment group was used to calculate the p-value.||||0.670
72474946|NCT01262677|144475159|SUPERIORITY|||||||0.927||||||Statistical testing was done at alpha = 0.05 level, two-sided.|Cochran-Mantel-Haenszel|||A 2-sided Cochran-Mantel-Haenszel test stratified by geographical region (U.S., Europe, Asia, or Rest of the World) wtih percentage of responders summarized by treatment group was used to calculate the p-value.||||0.927
72474947|NCT01262677|144475160|SUPERIORITY||LS Mean Difference|2.28||||0.8034|TWO_SIDED|95.0|-14.37|22.15||Statistical testing was done at 95% confidence intervals, two-sided, least square means and their standard errors.|ANCOVA||Value is percent reduction in seizures relative to placebo.|ANCOVA model with the following fixed terms was used to calculate the p-value: loge (baseline 28-day seizure rate + 1) as a coninuous covariate, sites pooled by geographic region (ie, U.S., Europe, Asia, rest of the world), and treatment group (placebo, pregabalin 165 mg CR, pregabalin 330 mg CR).||22.15|-14.37|0.8034
72474948|NCT01262677|144475160|SUPERIORITY||LS Mean Difference|-10.78||||0.1905|TWO_SIDED|95.0|-24.81|5.87||Statistical testing was done at 95% confidence intervals, two-sided, least square means and their standard errors.|ANCOVA||Value is percent reduction in seizures relative to placebo.|ANCOVA model with the following fixed terms was used to calculate the p-value: loge (baseline 28-day seizure rate + 1) as a coninuous covariate, sites pooled by geographic region (ie, U.S., Europe, Asia, rest of the world), and treatment group (placebo, pregabalin 165 mg CR, pregabalin 330 mg CR).||5.87|-24.81|0.1905
72474949|NCT01262677|144475161|SUPERIORITY||LS Mean Difference|-0.3||||0.465|TWO_SIDED|95.0|-1.1|0.5||Statistical testing was done at 95% confidence intervals, two-sided, least square means and their standard errors.|ANCOVA|||ANCOVA model with the following fixed terms was used to calculate the p-value: HADS-A baseline score as a coninuous covariate, sites pooled by geographic region (ie, U.S., Europe, Asia, rest of the world), and treatment group (placebo, pregabalin 165 mg controlled-release (CR), pregabalin 330 mg CR). No adjustments for multiplicity were taken.||0.5|-1.1|0.4650
72474950|NCT01262677|144475161|SUPERIORITY||LS Mean Difference|0.0||||0.9692|TWO_SIDED|95.0|-0.8|0.8||Statistical testing was done at 95% confidence intervals, two-sided, least square means and their standard errors.|ANCOVA|||ANCOVA model with the following fixed terms was used to calculate the p-value: HADS-A baseline score as a coninuous covariate, sites pooled by geographic region (ie, U.S., Europe, Asia, rest of the world), and treatment group (placebo, pregabalin 165 mg controlled-release (CR), pregabalin 330 mg CR). No adjustments for multiplicity were taken.||0.8|-0.8|0.9692
72474951|NCT01262677|144475162|SUPERIORITY||LS Mean Difference|-0.5||||0.2693|TWO_SIDED|95.0|-1.3|0.4||Statistical testing was done at 95% confidence intervals, two-sided, least square means and their standard errors.|ANCOVA|||ANCOVA model with the following fixed terms was used to calculate the p-value: HADS-D baseline score as a coninuous covariate, sites pooled by geographic region (ie, U.S., Europe, Asia, rest of the world), and treatment group (placebo, pregabalin 165 mg controlled-release (CR), pregabalin 330 mg CR). No adjustments for multiplicity were taken.||0.4|-1.3|0.2693
72474952|NCT01262677|144475162|SUPERIORITY||LS Mean Difference|-0.5||||0.1893|TWO_SIDED|95.0|-1.4|0.3||Statistical testing was done at 95% confidence intervals, two-sided, least square means and their standard errors.|ANCOVA|||ANCOVA model with the following fixed terms was used to calculate the p-value: HADS-D baseline score as a coninuous covariate, sites pooled by geographic region (ie, U.S., Europe, Asia, rest of the world), and treatment group (placebo, pregabalin 165 mg controlled-release (CR), pregabalin 330 mg CR). No adjustments for multiplicity were taken.||0.3|-1.4|0.1893
72474953|NCT01262677|144475163|SUPERIORITY||LS Mean Difference|-0.8||||0.7347|TWO_SIDED|95.0|-5.2|3.6||Statistical testing was done at alpha = 0.05 level, two-sided.|ANOVA|||ANCOVA model with the following fixed terms was used to calculate the p-value: sleep disturbance score at baseline as a coninuous covariate, sites pooled by geographic region (ie, U.S., Europe, Asia, rest of the world), and treatment group (placebo, pregabalin 165 mg CR, pregabalin 330 mg CR).||3.6|-5.2|0.7347
72474954|NCT01262677|144475163|SUPERIORITY||LS Mean Difference|0.3||||0.8971|TWO_SIDED|95.0|-4.0|4.6||Statistical testing was done at alpha = 0.05 level, two-sided.|ANCOVA|||ANCOVA model with the following fixed terms was used to calculate the p-value: sleep disturbance score at baseline as a coninuous covariate, sites pooled by geographic region (ie, U.S., Europe, Asia, rest of the world), and treatment group (placebo, pregabalin 165 mg CR, pregabalin 330 mg CR).||4.6|-4.0|0.8971
72507339|NCT02433210|144546543|SUPERIORITY||||||=|0.079|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||Session 2 Clearance of myoglobin Optiflux vs Revaclear.||||=0.079
72507340|NCT02433210|144546543|SUPERIORITY||||||=|0.086|||||||Wilcoxon (Mann-Whitney)|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||Session 2 Clearance of myoglobin Optiflux vs ELISIO.||||=0.086
72398412|NCT00546637|144303185|SUPERIORITY_OR_OTHER||Median Difference (Net)|6.0||||0.0005||95.0||||P-value was based on Van Elteren's Test adjusted by baseline quartiles. No adjustment of p-value was made for multiple comparisons.|Van Elteren's Test||Median difference was based on Hodges-Lehmann estimate of the location shift between the two groups.|Week 4||||0.0005
72507341|NCT02433210|144546543|SUPERIORITY||||||=|0.888|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||Session 2 Clearance myoglobin Revaclear vs ELISIO.||||=0.888
72507342|NCT02433210|144546543|SUPERIORITY||||||=|0.663||||||The p value was not adjusted for multiple comparisons and the difference was considered significant at the p\<0.05 level.|t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||Session 3 Clearance of urea nitrogen Optiflux vs Revaclear.||||=0.663
72507343|NCT02433210|144546543|SUPERIORITY||||||=|0.391|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||Session 3 Clearance of urea nitrogen Optiflux vs ELISIO.||||=0.391
72507344|NCT02433210|144546543|SUPERIORITY||||||=|0.214|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||Session 3 Clearance of urea nitrogen Revaclear vs ELISIO.||||=0.214
72474955|NCT01262677|144475164|SUPERIORITY||LS Mean Difference|-2.7||||0.3972|TWO_SIDED|95.0|-9.1|3.6||Statistical testing was done at alpha = 0.05 level, two-sided.|ANOVA|||ANCOVA model with the following fixed terms was used to calculate the p-value: snoring score at baseline as a coninuous covariate, sites pooled by geographic region (ie, U.S., Europe, Asia, rest of the world), and treatment group (placebo, pregabalin 165 mg CR, pregabalin 330 mg CR).||3.6|-9.1|0.3972
72474956|NCT01262677|144475164|SUPERIORITY||LS Mean Difference|6.7||||0.0319|TWO_SIDED|95.0|0.6|12.9||Statistical testing was done at alpha = 0.05 level, two-sided.|ANCOVA|||ANCOVA model with the following fixed terms was used to calculate the p-value: snoring score at baseline as a coninuous covariate, sites pooled by geographic region (ie, U.S., Europe, Asia, rest of the world), and treatment group (placebo, pregabalin 165 mg CR, pregabalin 330 mg CR).||12.9|0.6|0.0319
72474957|NCT01262677|144475165|SUPERIORITY||LS Mean Difference|0.8||||0.7708|TWO_SIDED|95.0|-4.4|5.9||Statistical testing was done at alpha = 0.05 level, two-sided.|ANOVA|||ANCOVA model with the following fixed terms was used to calculate the p-value: awaken short of breath or with headache score at baseline as a coninuous covariate, sites pooled by geographic region (ie, U.S., Europe, Asia, rest of the world), and treatment group (placebo, pregabalin 165 mg CR, pregabalin 330 mg CR).||5.9|-4.4|0.7708
72474958|NCT01262677|144475165|SUPERIORITY||LS Mean Difference|2.4||||0.356|TWO_SIDED|95.0|-2.7|7.4||Statistical testing was done at alpha = 0.05 level, two-sided.|ANCOVA|||ANCOVA model with the following fixed terms was used to calculate the p-value: awaken short of breath or with headache score at baseline as a coninuous covariate, sites pooled by geographic region (ie, U.S., Europe, Asia, rest of the world), and treatment group (placebo, pregabalin 165 mg CR, pregabalin 330 mg CR).||7.4|-2.7|0.3560
72474959|NCT01262677|144475166|SUPERIORITY||LS Mean Difference|0.2||||0.1129|TWO_SIDED|95.0|-0.1|0.5||Statistical testing was done at alpha = 0.05 level, two-sided.|ANOVA|||ANCOVA model with the following fixed terms was used to calculate the p-value: quantity of sleep at baseline as a coninuous covariate, sites pooled by geographic region (ie, U.S., Europe, Asia, rest of the world), and treatment group (placebo, pregabalin 165 mg CR, pregabalin 330 mg CR).||0.5|-0.1|0.1129
72474960|NCT01262677|144475166|SUPERIORITY||LS Mean Difference|0.0||||0.9388|TWO_SIDED|95.0|-0.3|0.3||Statistical testing was done at alpha = 0.05 level, two-sided.|ANCOVA|||ANCOVA model with the following fixed terms was used to calculate the p-value: quantity of sleep at baseline as a coninuous covariate, sites pooled by geographic region (ie, U.S., Europe, Asia, rest of the world), and treatment group (placebo, pregabalin 165 mg CR, pregabalin 330 mg CR).||0.3|-0.3|0.9388
72474961|NCT01262677|144475167|SUPERIORITY||LS Mean Difference|-0.4||||0.9053|TWO_SIDED|95.0|-7.5|6.6||Statistical testing was done at alpha = 0.05 level, two-sided.|ANOVA|||ANCOVA model with the following fixed terms was used to calculate the p-value: sleep adequacy score at baseline as a coninuous covariate, sites pooled by geographic region (ie, U.S., Europe, Asia, rest of the world), and treatment group (placebo, pregabalin 165 mg CR, pregabalin 330 mg CR).||6.6|-7.5|0.9053
72474962|NCT01262677|144475167|SUPERIORITY||LS Mean Difference|-1.6||||0.6371|TWO_SIDED|95.0|-8.5|5.2||Statistical testing was done at alpha = 0.05 level, two-sided.|ANCOVA|||ANCOVA model with the following fixed terms was used to calculate the p-value: sleep adequacy score at baseline as a coninuous covariate, sites pooled by geographic region (ie, U.S., Europe, Asia, rest of the world), and treatment group (placebo, pregabalin 165 mg CR, pregabalin 330 mg CR).||5.2|-8.5|0.6371
72474963|NCT01262677|144475168|SUPERIORITY||LS Mean Difference|-6.4||||0.0119|TWO_SIDED|95.0|-11.4|-1.4||Statistical testing was done at alpha = 0.05 level, two-sided.|ANOVA|||ANCOVA model with the following fixed terms was used to calculate the p-value: sleep somnolence score at baseline as a coninuous covariate, sites pooled by geographic region (ie, U.S., Europe, Asia, rest of the world), and treatment group (placebo, pregabalin 165 mg CR, pregabalin 330 mg CR).||-1.4|-11.4|0.0119
72474964|NCT01262677|144475168|SUPERIORITY||LS Mean Difference|0.0||||0.9909|TWO_SIDED|95.0|-4.9|4.8||Statistical testing was done at alpha = 0.05 level, two-sided.|ANCOVA|||ANCOVA model with the following fixed terms was used to calculate the p-value: sleep somnolence score at baseline as a coninuous covariate, sites pooled by geographic region (ie, U.S., Europe, Asia, rest of the world), and treatment group (placebo, pregabalin 165 mg CR, pregabalin 330 mg CR).||4.8|-4.9|0.9909
72398413|NCT00546637|144303185|SUPERIORITY_OR_OTHER||Median Difference (Net)|7.0|||<|0.0001||95.0||||P-value was based on Van Elteren's Test adjusted by baseline quartiles. No adjustment of p-value was made for multiple comparisons.|Van Elteren's Test||Median difference was based on Hodges-Lehmann estimate of the location shift between the two groups.|Week 8||||<.0001
72474965|NCT01262677|144475169|SUPERIORITY||LS Mean Difference|-1.1||||0.5903|TWO_SIDED|95.0|-5.0|2.8||Statistical testing was done at alpha = 0.05 level, two-sided.|ANOVA|||ANCOVA model with the following fixed terms was used to calculate the p-value: sleep problems index I score at baseline as a coninuous covariate, sites pooled by geographic region (ie, U.S., Europe, Asia, rest of the world), and treatment group (placebo, pregabalin 165 mg CR, pregabalin 330 mg CR).||2.8|-5.0|0.5903
72474966|NCT01262677|144475169|SUPERIORITY||LS Mean Difference|0.7||||0.7126|TWO_SIDED|95.0|-3.1|4.5||Statistical testing was done at alpha = 0.05 level, two-sided.|ANCOVA|||ANCOVA model with the following fixed terms was used to calculate the p-value: sleep problems index I score at baseline as a coninuous covariate, sites pooled by geographic region (ie, U.S., Europe, Asia, rest of the world), and treatment group (placebo, pregabalin 165 mg CR, pregabalin 330 mg CR).||4.5|-3.1|0.7126
72474967|NCT01262677|144475170|SUPERIORITY||LS Mean Difference|-2.1||||0.2431|TWO_SIDED|95.0|-5.8|1.5||Statistical testing was done at alpha = 0.05 level, two-sided.|ANOVA|||ANCOVA model with the following fixed terms was used to calculate the p-value: sleep problems index II score at baseline as a coninuous covariate, sites pooled by geographic region (ie, U.S., Europe, Asia, rest of the world), and treatment group (placebo, pregabalin 165 mg CR, pregabalin 330 mg CR).||1.5|-5.8|0.2431
72507345|NCT02433210|144546543|SUPERIORITY||||||=|0.918|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||Session 3 Clearance of creatinine Optiflux vs Revaclear.||||=0.918
72507346|NCT02433210|144546543|SUPERIORITY||||||=|0.394|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||Session 3 Clearance of creatinine Optiflux vs ELISIO.||||=0.394
72507347|NCT02433210|144546543|SUPERIORITY||||||=|0.211|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||Session 3 Clearance of creatinine Revaclear vs ELISIO.||||=0.211
72398414|NCT00546637|144303185|SUPERIORITY_OR_OTHER||Median Difference (Net)|9.0||||0.0003||95.0||||P-value was based on Van Elteren's Test adjusted by baseline quartiles. No adjustment of p-value was made for multiple comparisons.|Van Elteren's Test||Median difference was based on Hodges-Lehmann estimate of the location shift between the two groups.|Week 12||||0.0003
72398415|NCT00546637|144303186|SUPERIORITY_OR_OTHER||Median Difference (Net)|-0.4||||0.2251||95.0||||P-value was based on Van Elteren's Test adjusted by baseline quartiles. No adjustment of p-value was made for multiple comparisons.|Van Elteren's Test||Median difference was based on Hodges-Lehmann estimate of the location shift between the two groups.|||||0.2251
72398416|NCT03274440|144303189|OTHER|A random-effects linear mixed model evaluated changes in YBOCCS as a function of condition (THC, CBD, placebo \[PBO\]), time point, and their interaction.||||||0.577|||||||Linear mixed effects regression|||Test for interaction effect between condition and time (includes all three groups and all time points)||||.577
72398417|NCT03274440|144303189|OTHER|A random-effects linear mixed model evaluated changes in YBOCCS as a function of condition (THC, CBD, placebo \[PBO\]), time point, and their interaction.|||||<|0.001|||||||Linear mixed effects regression|F=10.50; df=6, 10||Test for main effect of time (includes all three groups and all time points)||||<.001
72398418|NCT03274440|144303189|OTHER|A random-effects linear mixed model evaluated changes in YBOCCS as a function of condition (THC, CBD, placebo \[PBO\]), time point, and their interaction.||||||0.72|||||||Linear mixed effects regression|||Test for main effect of condition (includes all three groups and all time points)||||.72
72474968|NCT01262677|144475170|SUPERIORITY||LS Mean Difference|0.3||||0.8654|TWO_SIDED|95.0|-3.2|3.8||Statistical testing was done at alpha = 0.05 level, two-sided.|ANCOVA|||ANCOVA model with the following fixed terms was used to calculate the p-value: sleep problems index II score at baseline as a coninuous covariate, sites pooled by geographic region (ie, U.S., Europe, Asia, rest of the world), and treatment group (placebo, pregabalin 165 mg CR, pregabalin 330 mg CR).||3.8|-3.2|0.8654
72474969|NCT01262677|144475171|SUPERIORITY||Odds Ratio (OR)|1.36||||0.3241|TWO_SIDED|95.0|0.74|2.5||Statistical testing was done at alpha = 0.05 level, two-sided.|Regression, Logistic|||Logistic regression model was used to calculate the p-value, with the fixed effects for sites pooled by geographic region (ie, U.S., Europe, Asia, rest of the world), and treatment group (placebo, pregabalin 165 mg controlled-release (CR), pregabalin 330 mg CR), average hours per night of sleep at baseline as a coninuous covariate, and optimal sleep at Week 14 as dependent variable. No adjustments for multiplicity were taken.||2.50|0.74|0.3241
72474970|NCT01262677|144475171|SUPERIORITY||Odds Ratio (OR)|0.96||||0.8932|TWO_SIDED|95.0|0.54|1.71||Statistical testing was done at alpha = 0.05 level, two-sided.|Regression, Logistic|||Logistic regression model was used to calculate the p-value, with the fixed effects for sites pooled by geographic region (ie, U.S., Europe, Asia, rest of the world), and treatment group (placebo, pregabalin 165 mg controlled-release (CR), pregabalin 330 mg CR), average hours per night of sleep at baseline as a coninuous covariate, and optimal sleep at Week 14 as dependent variable. No adjustments for multiplicity were taken.||1.71|0.54|0.8932
72474971|NCT00574873|144475182|SUPERIORITY_OR_OTHER|||||||0.667||||||p-value was based on a Cochran Mantel Haenszel test for general association between treatment and responder stratification by Sokal risk group (low, intermediate, high) and region (1 to 3) as determined at time of randomization.|Stratified Cochran-Mantel-Haenszel|||||||0.667
72474972|NCT00574873|144475183|SUPERIORITY_OR_OTHER|||||||0.002||||||p-value was based on a Cochran Mantel Haenszel test for general association between treatment and responder stratification by Sokal risk group (low, intermediate, high) and region (1 to 3) as determined at time of randomization.|Stratified Cochran-Mantel-Haenszel|||||||0.002
72507348|NCT02433210|144546543|SUPERIORITY||||||=|0.222|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||Session 3 Clearance of phosphate Optiflux vs ELISIO.||||=0.222
72507349|NCT02433210|144546543|SUPERIORITY||||||=|0.162|||||||Wilcoxon (Mann-Whitney)|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||Session 3 Clearances of phosphate Revaclear vs ELISIO.||||=0.162
72398419|NCT03274440|144303190|OTHER|A random-effects linear mixed model evaluated changes in STAI-S as a function of condition (THC, CBD, placebo \[PBO\]), time point, and their interaction.||||||0.577|||||||Linear mixed effects regression|||Test for interaction between condition and time||||.577
72398420|NCT03274440|144303190|OTHER|A random-effects linear mixed model evaluated changes in STAI-S as a function of condition (THC, CBD, placebo \[PBO\]), time point, and their interaction.|||||<|0.001|||||||Linear mixed effects regression|F=7.00, df=6,10||Test for main effect of time||||<.001
72398421|NCT03274440|144303190|OTHER|A random-effects linear mixed model evaluated changes in STAI-S as a function of condition (THC, CBD, placebo \[PBO\]), time point, and their interaction.||||||0.002|||||||Linear mixed effects regression|F=6.26, df=2, 10||Test for main effect of condition||||.002
72398422|NCT01074450|144303191|NON_INFERIORITY_OR_EQUIVALENCE|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|100.93|||||TWO_SIDED|90.0|94.23|108.1|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||108.1|94.23|
72398423|NCT01074450|144303192|NON_INFERIORITY_OR_EQUIVALENCE|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|104.71|||||TWO_SIDED|90.0|99.74|109.92|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||109.92|99.74|
72398424|NCT01074450|144303193|NON_INFERIORITY_OR_EQUIVALENCE|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|104.15|||||TWO_SIDED|90.0|99.05|109.52|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||109.52|99.05|
72398425|NCT04984993|144303194|OTHER||||||<|0.001||||||Significance level of 0.025|t-test, 1 sided|||Null hypothesis: mu \<= 0 versus alternative hypothesis: mu \>0, where mu is the population mean change from baseline in the EF domain of the IIEF questionnaire at week 24.||||<0.001
72474973|NCT00574873|144475184|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.64|||||TWO_SIDED|95.0|0.31|1.31|||||Hazard ratio (95% confidence interval) based on the treatment effect (bosutinib compared with imatinib) in a stratified (by Sokal risk group and region at randomization) Cox model for the hazard of the respective event.|||1.31|0.31|
72474974|NCT00574873|144475185|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.59|||||TWO_SIDED|95.0|0.32|1.08|||||Hazard ratio (95% confidence interval) based on the treatment effect (bosutinib compared with imatinib) in a stratified (by Sokal risk group and region at randomization) Cox model for the hazard of the respective event.|||1.08|0.32|
72474975|NCT00574873|144475186|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|3.25|||||TWO_SIDED|95.0|0.9|11.72|||||Hazard ratio (95% confidence interval) based on the treatment effect (bosutinib compared with imatinib) in a stratified (by Sokal risk group and region at randomization) Cox model for the hazard of the respective event.|||11.72|0.90|
72474976|NCT00574873|144475187|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.41|||||TWO_SIDED|95.0|0.13|1.29|||||The hazard ratio (95% confidence interval) is obtained from a Cox model for cause-specific hazard as a function of the covariate treatment (bosutinib compared with imatinib) with stratification by region and Sokal risk group at randomization.|||1.29|0.13|
72474977|NCT02055781|144475202|SUPERIORITY|||||||0.0011|||||||Fisher Exact|||BAT arm compared to pooled pacritinib arms (QD + BID - ITT Efficacy)||||0.0011
72507350|NCT02433210|144546543|SUPERIORITY||||||<|0.001||||||The p value was not adjusted for multiple comparisons and the difference was considered significant at the p\<0.05 level.|t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||Session 3 Clearance of beta 2 microglobulin Optiflux vs Revaclear.||||<0.001
72474978|NCT02055781|144475202|SUPERIORITY|||||||0.0173|||||||Fisher Exact|||||||0.0173
72507351|NCT02433210|144546543|SUPERIORITY||||||=|0.025||||||The p value was not adjusted for multiple comparisons and the difference was considered significant at the p\<0.05 level.|Wilcoxon (Mann-Whitney)|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||Session 3 Clearances of beta 2 microglobulin Optiflux vs ELISIO.||||=0.025
72398426|NCT04984993|144303195|OTHER||||||<|0.001||||||Significance level of 0.025|t-test, 1 sided|||Null hypothesis: mu \<= 30 versus alternative hypothesis: mu \>30, where mu is the population mean percentage of MED3000 uses per patient that resulted in the patient noticing their erection starting within 15 minutes.||||<0.001
72474979|NCT02055781|144475202|SUPERIORITY|||||||0.0007|||||||Fisher Exact|||||||0.0007
72474980|NCT02055781|144475203|SUPERIORITY|||||||0.0791|||||||Fisher Exact|||BAT arm compared to pooled pacritinib arms (QD + BID - ITT Efficacy)||||0.0791
72474981|NCT02055781|144475203|SUPERIORITY|||||||0.6524|||||||Fisher Exact|||||||0.6524
72507352|NCT02433210|144546543|SUPERIORITY||||||=|0.903|||||||Wilcoxon (Mann-Whitney)|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||Session 3 Clearance of beta 2 microglobulin Revaclear vs ELISIO.||||=0.903
72474982|NCT02055781|144475203|SUPERIORITY|||||||0.0106|||||||Fisher Exact|||||||0.0106
72474983|NCT00201643|144475204|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.45|STANDARD_ERROR_OF_MEAN|0.1162||0.002|TWO_SIDED|95.0|0.27|0.75||Analysis were also conducted in all randomized women with a known outcome \& in randomized treatment group(modified intent to treat). Analysis of the primary outcome used a repeated measures approach where each baby was considered a repeated measure|Fisher Exact|||Our Hypothesis was that administration of a rescue ACS would show a 40% reduction in incidence of composite neonatal morbity in patients delivering \< 34 weeks. Sample size estimates based on composite morbidity of 28%. Each arm required 217 subjects to have 80% power to detect a 40% reduction to 16.8%(2-tailed,alpha =0.05)using comparison for proportions/groups(Fisher exact test) OR,95% CI \& P values were determined using a repeated measure model where each twin is considered a repeat measure.||0.75|0.27|0.002
72474984|NCT03568318|144475247|SUPERIORITY|The overall type I error rate of the coprimary and all key secondary endpoints for upadacitinib 30 mg was controlled at the 0.05 level using a graphical multiple testing procedure following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|50.6|||<|0.001|TWO_SIDED|95.0|43.8|57.4|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||57.4|43.8|<0.001
72474985|NCT03568318|144475247|SUPERIORITY|The overall type I error rate of the coprimary and all key secondary endpoints for upadacitinib 15 mg was controlled at the 0.05 level using a graphical multiple testing procedure following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|38.1|||<|0.001|TWO_SIDED|95.0|30.8|45.4|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||45.4|30.8|<0.001
72507353|NCT02433210|144546543|SUPERIORITY||||||=|0.003||||||The p value was not adjusted for multiple comparisons and the difference was considered significant at the p\<0.05 level.|Wilcoxon (Mann-Whitney)|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||Session 3 Clearances of myoglobin Optiflux vs Revaclear.||||=0.003
72507354|NCT02433210|144546543|SUPERIORITY||||||<|0.001||||||The p value was not adjusted for multiple comparisons and the difference was considered significant at the p\<0.05 level.|Wilcoxon (Mann-Whitney)|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||Session 3 Clearance of myoglobin Optiflux vs ELISIO.||||<0.001
72507355|NCT02433210|144546543|SUPERIORITY||||||=|0.472|||||||Wilcoxon (Mann-Whitney)|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||Session 3 Clearance of myoglobin Revaclear vs ELISIO.||||=0.472
72507356|NCT02433210|144546544|SUPERIORITY||||||=|0.216||||||The p value was not adjusted for multiple comparisons and the difference was considered significant at the p\<0.05 level.|t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.216
72398427|NCT04984993|144303195|OTHER||||||<|0.001||||||Significance level of 0.025|t-test, 1 sided|||Null hypothesis: mu \<= 30 versus alternative hypothesis: mu \>30, where mu is the population mean percentage of MED3000 uses per patient that resulted in the patient noticing their erection starting within 10 minutes.||||<0.001
72398428|NCT04984993|144303195|OTHER|||||||0.89||||||Significance level of 0.025|t-test, 1 sided|||Null hypothesis: mu \<= 30 versus alternative hypothesis: mu \>30, where mu is the population mean percentage of MED3000 uses per patient that resulted in the patient noticing their erection starting within 5 minutes.||||0.890
72398429|NCT04984993|144303196|OTHER||||||<|0.001||||||Significance level of 0.025|t-test, 1 sided|||||||<0.001
72398430|NCT04984993|144303196|OTHER|||||||0.3327||||||Significance level of 0.025|t-test, 1 sided|||||||0.3327
72474986|NCT03568318|144475248|SUPERIORITY|The overall type I error rate of the coprimary and all key secondary endpoints for upadacitinib 30 mg was controlled at the 0.05 level using a graphical multiple testing procedure following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|47.6|||<|0.001|TWO_SIDED|95.0|41.1|54.0|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response rate difference = Upadacitinib - Placebo|||54.0|41.1|<0.001
72398431|NCT04984993|144303196|OTHER||||||>|0.999||||||Significance level of 0.025|t-test, 1 sided|||||||>0.999
72474987|NCT03568318|144475248|SUPERIORITY|The overall type I error rate of the coprimary and all key secondary endpoints for upadacitinib 15 mg was controlled at the 0.05 level using a graphical multiple testing procedure following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|28.5|||<|0.001|TWO_SIDED|95.0|22.1|34.9|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response rate difference = Upadacitinib - Placebo|||34.9|22.1|<0.001
72474988|NCT03568318|144475249|SUPERIORITY|The overall type I error rate of the coprimary and all key secondary endpoints for upadacitinib 30 mg was controlled at the 0.05 level using a graphical multiple testing procedure following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|48.8|||<|0.001|TWO_SIDED|95.0|41.9|55.7|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||55.7|41.9|<0.001
72474989|NCT03568318|144475249|SUPERIORITY|The overall type I error rate of the coprimary and all key secondary endpoints for upadacitinib 15 mg was controlled at the 0.05 level using a graphical multiple testing procedure following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|36.8|||<|0.001|TWO_SIDED|95.0|29.7|43.8|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||43.8|29.7|<0.001
72474990|NCT03568318|144475250|SUPERIORITY|The overall type I error rate of the coprimary and all key secondary endpoints for upadacitinib 30 mg was controlled at the 0.05 level using a graphical multiple testing procedure following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|49.9|||<|0.001|TWO_SIDED|95.0|43.3|56.4|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||56.4|43.3|<0.001
72474991|NCT03568318|144475250|SUPERIORITY|The overall type I error rate of the coprimary and all key secondary endpoints for upadacitinib 15 mg was controlled at the 0.05 level using a graphical multiple testing procedure following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|29.5|||<|0.001|TWO_SIDED|95.0|22.8|36.3|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||36.3|22.8|<0.001
72507357|NCT02433210|144546544|SUPERIORITY|No significant difference|||||=|0.216||||||The p value was not adjusted for multiple comparisons and the difference was considered significant at the p\<0.05 level.|t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.216
72507358|NCT02433210|144546544|SUPERIORITY|No significant difference|||||=|0.952||||||The p value was not adjusted for multiple comparisons and the difference was considered significant at the p\<0.05 level.|t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.952
72398432|NCT02865187|144303199|SUPERIORITY||Mean Difference (Final Values)|0.0|STANDARD_DEVIATION|7.0||0.71|TWO_SIDED|95.0|-7.4|5.1||a priori threshold for significance was set at p\<0.05|t-test, 2 sided|||||5.1|-7.4|0.71
72398433|NCT02865187|144303200|SUPERIORITY||Chi square|0.0||||1|TWO_SIDED|||||a priori threshold for significance was set at p\< 0.05.|Chi-squared|||||||1.00
72398434|NCT00385996|144303249|SUPERIORITY_OR_OTHER||||||<|0.01|||||||Binomial distribution|Binomial distribution and test proportion =0.50||One arm phase 2 trial. This study is designed to asses response rate and defined as the percentage of subjects achieving at least 50% tumor volume. One-sided alpha is set at no more than 5% and the power no less than 90%,and the null hypothesis of RR of less than 10% and alternative hypothesis of RR of greater than 30%, a total of 30 patients will be enrolled (Fleming 1982).At least 7 responders out of 30 patients are needed to reject the null hypothesis of a 10% RR.||||<0.01
72398435|NCT00385996|144303251|OTHER||TTP [% without disease at 24 months]|63.6|||||TWO_SIDED|95.0|43.4|83.8|||||Using the Kaplan-Meier method.|One arm study||83.8|43.4|
72398436|NCT00385996|144303252|OTHER||% alive without disease at 25 months|72.7|||||TWO_SIDED|95.0|54.1|91.3|||||Using the Kaplan-Meier method.|One arm study||91.3|54.1|
72398437|NCT04249310|144303256|OTHER||Hazard Ratio (HR)|0.89|||||TWO_SIDED|95.0|0.32|2.46|||||\[(Tiotropium/Olodaterol) / Tiotropium\] Cox-regression was used to estimate the hazard ratios and 95% confidence intervals.|||2.46|0.32|
72398438|NCT04249310|144303257|OTHER||Hazard Ratio (HR)|0.85|||||TWO_SIDED|95.0|0.63|1.15|||||\[(Tiotropium/Olodaterol) / Tiotropium\] Cox regression was used to estimate the hazard ratios and 95% confidence intervals.|Moderate or Severe COPD Exacerbation||1.15|0.63|
72398439|NCT04249310|144303257|OTHER||Hazard Ratio (HR)|0.66|||||TWO_SIDED|95.0|0.43|1.01|||||\[(Tiotropium/Olodaterol) / Tiotropium\] Cox regression was used to estimate the hazard ratios and 95% confidence intervals.|Moderate COPD Exacerbation||1.01|0.43|
72507359|NCT02433210|144546544|SUPERIORITY|No Significant difference|||||=|0.714||||||The p value was not adjusted for multiple comparisons and the difference was considered significant at the p\<0.05 level.|t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.714
72507360|NCT02433210|144546544|SUPERIORITY||||||=|0.156||||||The p value was not adjusted for multiple comparisons and the difference was considered significant at the p\<0.05 level.|t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.156
72507361|NCT02433210|144546544|SUPERIORITY||||||=|0.427||||||The p value was not adjusted for multiple comparisons and the difference was considered significant at the p\<0.05 level.|t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.427
72474992|NCT03568318|144475251|SUPERIORITY|The overall type I error rate of the coprimary and all key secondary endpoints for upadacitinib 30 mg was controlled at the 0.05 level using a graphical multiple testing procedure following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|50.6|||<|0.001|TWO_SIDED|95.0|43.8|57.3|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||57.3|43.8|<0.001
72474993|NCT03568318|144475251|SUPERIORITY|The overall type I error rate of the coprimary and all key secondary endpoints for upadacitinib 15 mg was controlled at the 0.05 level using a graphical multiple testing procedure following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|37.4|||<|0.001|TWO_SIDED|95.0|30.4|44.3|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||44.3|30.4|<0.001
72474994|NCT03568318|144475252|SUPERIORITY|The overall type I error rate of the coprimary and all key secondary endpoints for upadacitinib 30 mg was controlled at the 0.05 level using a graphical multiple testing procedure following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|57.6|||<|0.001|TWO_SIDED|95.0|51.2|63.9|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||63.9|51.2|<0.001
72474995|NCT03568318|144475252|SUPERIORITY|The overall type I error rate of the coprimary and all key secondary endpoints for upadacitinib 15 mg was controlled at the 0.05 level using a graphical multiple testing procedure following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|43.8|||<|0.001|TWO_SIDED|95.0|37.0|50.5|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||50.5|37.0|<0.001
72474996|NCT03568318|144475253|SUPERIORITY|The overall type I error rate of the coprimary and all key secondary endpoints for upadacitinib 30 mg was controlled at the 0.05 level using a graphical multiple testing procedure following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|37.2|||<|0.001|TWO_SIDED|95.0|31.0|43.3|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||43.3|31.0|<0.001
72474997|NCT03568318|144475253|SUPERIORITY|The overall type I error rate of the coprimary and all key secondary endpoints for upadacitinib 15 mg was controlled at the 0.05 level using a graphical multiple testing procedure following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|24.0|||<|0.001|TWO_SIDED|95.0|18.1|29.9|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||29.9|18.1|<0.001
72474998|NCT03568318|144475254|SUPERIORITY|The overall type I error rate of the coprimary and all key secondary endpoints for upadacitinib 30 mg was controlled at the 0.05 level using a graphical multiple testing procedure following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|38.8|||<|0.001|TWO_SIDED|95.0|32.8|44.8|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||44.8|32.8|<0.001
72474999|NCT03568318|144475254|SUPERIORITY|The overall type I error rate of the coprimary and all key secondary endpoints for upadacitinib 15 mg was controlled at the 0.05 level using a graphical multiple testing procedure following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|23.3|||<|0.001|TWO_SIDED|95.0|17.7|28.9|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||28.9|17.7|<0.001
72475000|NCT03568318|144475255|SUPERIORITY|The overall type I error rate of the coprimary and all key secondary endpoints for upadacitinib 30 mg was controlled at the 0.05 level using a graphical multiple testing procedure following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|21.2|||<|0.001|TWO_SIDED|95.0|16.3|26.1|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||26.1|16.3|<0.001
72475001|NCT03568318|144475256|SUPERIORITY|The overall type I error rate of the coprimary and all key secondary endpoints for upadacitinib 30 mg was controlled at the 0.05 level using a graphical multiple testing procedure following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|16.2|||<|0.001|TWO_SIDED|95.0|11.3|21.1|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||21.1|11.3|<0.001
72398440|NCT04249310|144303257|OTHER||Hazard Ratio (HR)|0.9|||||TWO_SIDED|95.0|0.62|1.31|||||\[(Tiotropium/Olodaterol) / Tiotropium\] Cox regression was used to estimate the hazard ratios and 95% confidence intervals.|Severe COPD Exacerbation||1.31|0.62|
72398441|NCT02733991|144303310|SUPERIORITY||Mean Difference (Final Values)|-2.88|||<|0.0001|TWO_SIDED|95.0|-3.51|-2.25|||Mixed Models Analysis||Model based Estimated mean; Treatment arm - Control arm|||-2.25|-3.51|<0.0001
72398442|NCT02733991|144303311|SUPERIORITY||Mean Difference (Final Values)|-42.62|||<|0.0001|TWO_SIDED|95.0|-52.01|-33.19|||Mixed Models Analysis||Model based Estimated mean; Treatment arm - Control arm|||-33.19|-52.01|<0.0001
72398443|NCT02733991|144303312|NON_INFERIORITY|Non-inferiority margin of 40 min/day|Mean Difference (Final Values)|-38.8|||||ONE_SIDED|97.5||-0.46|||||Model based Estimated mean; difference = control arm - treatment arm|||-0.46||
72398444|NCT02733991|144303312|SUPERIORITY||Mean Difference (Final Values)|38.8||||0.0474|TWO_SIDED|95.0|0.46|77.11|||Mixed Models Analysis||Model based Estimated mean; Difference = Treatment arm - Control arm|||77.11|0.46|0.0474
72398445|NCT05167734|144303313|SUPERIORITY||Mean Difference (Final Values)|0.7||||0.02|TWO_SIDED|95.0|0.1|1.2|||Mixed Models Analysis|linear mixed effects model adjusting for baseline hemoglobin, age, sex, and surgical vs. non-surgical admission|values greater than 0 infer higher hemoglobin in active intervention|||1.2|0.1|0.02
72398446|NCT05167734|144303314|SUPERIORITY||Mean Difference (Final Values)|0.6||||0.04|TWO_SIDED|95.0|0.0|1.1|||Mixed Models Analysis|linear mixed effects model adjusting for baseline hemoglobin, age, sex, and surgical vs. non-surgical admission|adjusted mean difference|3-months post hospitalization||1.1|0.0|0.04
72398447|NCT05167734|144303314|SUPERIORITY||Mean Difference (Net)|0.2||||0.42|TWO_SIDED|95.0|-0.3|0.7|||Mixed Models Analysis|linear mixed effects model adjusting for baseline hemoglobin, age, sex, and surgical vs. non-surgical admission||Hospital Discharge||0.7|-0.3|0.42
72398448|NCT05167734|144303315|SUPERIORITY|||||||0.352|||||||Mixed Models Analysis|||||||0.352
72398449|NCT05167734|144303316|SUPERIORITY||||||<|0.001||||||threshold for significance - p\<0.05|Mixed Models Analysis|||||||<0.001
72398450|NCT05167734|144303317|SUPERIORITY||Odds Ratio (OR)|1.03||||0.94|TWO_SIDED|95.0|0.44|2.4|||proportional odds|proportional odds models adjusting for baseline hemoglobin, age, sex, and surgical vs. non-surgical admission|Estimates are odds ratios and correspond to the multiplicative increase in odds of higher value/score associated with active intervention|Hospital Discharge||2.40|0.44|0.94
72398451|NCT05167734|144303317|SUPERIORITY||Odds Ratio (OR)|1.79||||0.18|TWO_SIDED|95.0|0.76|4.2|||proportional odds|proportional odds models adjusting for baseline hemoglobin, age, sex, and surgical vs. non-surgical admission|Estimates are odds ratios and correspond to the multiplicative increase in odds of higher value/score associated with active intervention|1-month post hospitalization||4.20|0.76|0.18
72398452|NCT05167734|144303317|SUPERIORITY||Odds Ratio (OR)|1.23||||0.64|TWO_SIDED|95.0|0.51|3.0|||proportional odds|proportional odds models adjusting for baseline hemoglobin, age, sex, and surgical vs. non-surgical admission|Estimates are odds ratios and correspond to the multiplicative increase in odds of higher value/score associated with active intervention|3-months post hospitalization||3.00|0.51|0.64
72398453|NCT05167734|144303318|SUPERIORITY||Odds Ratio (OR)|1.81||||0.23|TWO_SIDED|95.0|0.68|4.8|||proportional odds|proportional odds models adjusting for baseline hemoglobin, age, sex, and surgical vs. non-surgical admission|Estimates are odds ratios and correspond to the multiplicative increase in odds of higher value/score associated with active intervention|Hospital discharge||4.80|0.68|0.23
72475002|NCT03568318|144475256|SUPERIORITY|The overall type I error rate of the coprimary and all key secondary endpoints for upadacitinib 15 mg was controlled at the 0.05 level using a graphical multiple testing procedure following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|9.2|||<|0.001|TWO_SIDED|95.0|4.9|13.4|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||13.4|4.9|<0.001
72475003|NCT03568318|144475257|SUPERIORITY|The overall type I error rate of the coprimary and all key secondary endpoints for upadacitinib 30 mg was controlled at the 0.05 level using a graphical multiple testing procedure following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer. This endpoint was a multiplicity-controlled key secondary endpoint for European Union (EU)/European Medicines Agency (EMA) regulatory purposes only.|Least Squares (LS) Mean Difference|-41.79|STANDARD_ERROR_OF_MEAN|4.417|<|0.001|TWO_SIDED|95.0|-50.46|-33.11|||Mixed Effect Model Repeated Measurement|Mixed-effect model repeat measurement with Baseline, treatment, visit, treatment by visit interaction, Baseline vIGA-AD category and age in the model.|Difference = Upadacitinib - Placebo|||-33.11|-50.46|<0.001
72475004|NCT03568318|144475257|SUPERIORITY|The overall type I error rate of the coprimary and all key secondary endpoints for upadacitinib 15 mg was controlled at the 0.05 level using a graphical multiple testing procedure following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer. This endpoint was a multiplicity-controlled key secondary endpoint for European Union (EU)/European Medicines Agency (EMA) regulatory purposes only.|LS Mean Difference|-33.08|STANDARD_ERROR_OF_MEAN|4.403|<|0.001|TWO_SIDED|95.0|-41.72|-24.44|||Mixed Effect Model Repeated Measurement|Mixed-effect model repeat measurement with Baseline, treatment, visit, treatment by visit interaction, Baseline vIGA-AD category and age in the model.|Difference = Upadacitinib - Placebo|||-24.44|-41.72|<0.001
72507362|NCT02433210|144546544|SUPERIORITY||||||=|0.487||||||The p value was not adjusted for multiple comparisons and the difference was considered significant at the p\<0.05 level.|t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||No significant difference||||=0.487
72507363|NCT02433210|144546544|SUPERIORITY|Failed normality test|||||=|0.111||||||The p value was not adjusted for multiple comparisons and the difference was considered significant at the p\<0.05 level.|Wilcoxon (Mann-Whitney)|The difference in the median values between the two groups is not \> enough to exclude that the difference is due to random sampling variability||No significant difference||||=0.111
72398454|NCT05167734|144303318|SUPERIORITY||Odds Ratio (OR)|2.43||||0.09|TWO_SIDED|95.0|0.87|6.8|||proportional odds|proportional odds models adjusting for baseline hemoglobin, age, sex, and surgical vs. non-surgical admission|Estimates are odds ratios and correspond to the multiplicative increase in odds of higher value/score associated with active intervention|1-month post hospitalization||6.80|0.87|0.09
72398455|NCT05167734|144303318|SUPERIORITY||Odds Ratio (OR)|2.52||||0.084|TWO_SIDED|95.0|0.88|7.2|||proportional odds|proportional odds models adjusting for baseline hemoglobin, age, sex, and surgical vs. non-surgical admission|Estimates are odds ratios and correspond to the multiplicative increase in odds of higher value/score associated with active intervention|3-months post hospitalization||7.20|0.88|0.084
72475005|NCT03568318|144475258|SUPERIORITY||LS Mean Difference|-41.45|STANDARD_ERROR_OF_MEAN|2.662|<|0.001|TWO_SIDED|95.0|-46.68|-36.22|||Mixed Effect Model Repeated Measurement|Mixed-effect model repeat measurement with Baseline, treatment, visit, treatment by visit interaction, Baseline vIGA-AD category and age in the model.|Difference = Upadacitinib - Placebo|The overall type I error rate of the coprimary and all key secondary endpoints for upadacitinib 30 mg was controlled at the 0.05 level using a graphical multiple testing procedure following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer. This endpoint was a multiplicity-controlled key secondary endpoint for EU/EMA regulatory purposes only.||-36.22|-46.68|<0.001
72475006|NCT03568318|144475258|SUPERIORITY|The overall type I error rate of the coprimary and all key secondary endpoints for upadacitinib 15 mg was controlled at the 0.05 level using a graphical multiple testing procedure following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer. This endpoint was a multiplicity-controlled key secondary endpoint for EU/EMA regulatory purposes only.|LS Mean Difference|-32.13|STANDARD_ERROR_OF_MEAN|2.659|<|0.001|TWO_SIDED|95.0|-37.35|-26.91|||Mixed Effect Model Repeated Measurement|Mixed-effect model repeat measurement with Baseline, treatment, visit, treatment by visit interaction, Baseline vIGA-AD category and age in the model.|Difference = Upadacitinib - Placebo|||-26.91|-37.35|<0.001
72475007|NCT03568318|144475259|SUPERIORITY||Adjusted Response Rate Difference|53.1|||<|0.001|TWO_SIDED|95.0|38.8|67.4|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||67.4|38.8|<0.001
72475008|NCT03568318|144475259|SUPERIORITY||Adjusted Response Rate Difference|32.7|||<|0.001|TWO_SIDED|95.0|16.3|49.0|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||49.0|16.3|<0.001
72475009|NCT03568318|144475260|SUPERIORITY||Adjusted Response Rate Difference|55.4|||<|0.001|TWO_SIDED|95.0|41.4|69.5|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||69.5|41.4|<0.001
72566094|NCT04146363|144662931|SUPERIORITY||Risk Difference (RD)|1.7||||0.218644|TWO_SIDED|95.0|-0.6|4.0|||Cochran-Mantel-Haenszel|||||4.0|-0.6|0.218644
72398456|NCT05167734|144303319|SUPERIORITY||Mean Difference (Net)|218.0||||0.13|TWO_SIDED|95.0|-73.0|510.0|||Mixed Models Analysis|adjusting for baseline hemoglobin, age, sex, surgical vs. non-surgical admission, and baseline ADLs|scores greater than 0 reflect greater ambulatory distance in active intervention|1-month post hospitalization||510|-73|0.13
72475010|NCT03568318|144475260|SUPERIORITY||Adjusted Response Rate Difference|26.3|||<|0.001|TWO_SIDED|95.0|12.1|40.4|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||40.4|12.1|<0.001
72475011|NCT03568318|144475261|SUPERIORITY||Adjusted Response Rate Difference|30.5|||<|0.001|TWO_SIDED|95.0|14.1|46.8|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||46.8|14.1|<0.001
72475012|NCT03568318|144475261|SUPERIORITY||Adjusted Response Rate Difference|24.5||||0.003|TWO_SIDED|95.0|8.2|40.8|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||40.8|8.2|0.003
72475013|NCT03568318|144475262|SUPERIORITY||Adjusted Response Rate Difference|52.0|||<|0.001|TWO_SIDED|95.0|37.3|66.7|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||66.7|37.3|<0.001
72475014|NCT03568318|144475262|SUPERIORITY||Adjusted Response Rate Difference|27.1||||0.001|TWO_SIDED|95.0|11.1|43.1|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||43.1|11.1|0.001
72475015|NCT03568318|144475263|SUPERIORITY||Adjusted Response Rate Difference|23.5||||0.006|TWO_SIDED|95.0|6.9|40.1|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||40.1|6.9|0.006
72475016|NCT03568318|144475263|SUPERIORITY||Adjusted Response Rate Difference|22.7||||0.007|TWO_SIDED|95.0|6.2|39.2|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||39.2|6.2|0.007
72475017|NCT03568318|144475264|SUPERIORITY||Adjusted Response Rate Difference|49.3|||<|0.001|TWO_SIDED|95.0|34.1|64.6|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||64.6|34.1|<0.001
72475018|NCT03568318|144475264|SUPERIORITY||Adjusted Response Rate Difference|26.2||||0.002|TWO_SIDED|95.0|9.4|43.1|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||43.1|9.4|0.002
72475019|NCT03568318|144475265|SUPERIORITY||Adjusted Response Rate Difference|41.5|||<|0.001|TWO_SIDED|95.0|27.8|55.1|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||55.1|27.8|<0.001
72475020|NCT03568318|144475265|SUPERIORITY||Adjusted Response Rate Difference|24.4||||0.001|TWO_SIDED|95.0|10.3|38.4|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||38.4|10.3|0.001
72475021|NCT03568318|144475266|SUPERIORITY||Adjusted Response Rate Difference|34.9|||<|0.001|TWO_SIDED|95.0|20.6|49.3|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||49.3|20.6|<0.001
72566095|NCT04146363|144662932|SUPERIORITY||Risk Difference (RD)|9.6||||0.000498|TWO_SIDED|95.0|5.7|13.6|||Cochran-Mantel-Haenszel|||||13.6|5.7|0.000498
72566096|NCT04146363|144662933|SUPERIORITY||Risk Difference (RD)|30.8|||<|1e-06|TWO_SIDED|95.0|22.1|39.4|||Cochran-Mantel-Haenszel|||||39.4|22.1|<0.000001
72566097|NCT04146363|144662934|SUPERIORITY||Risk Difference (RD)|28.8|||<|1e-06|TWO_SIDED|95.0|21.3|36.3|||Cochran-Mantel-Haenszel|||||36.3|21.3|<0.000001
72398457|NCT05167734|144303319|SUPERIORITY||Median Difference (Net)|178.0||||0.27|TWO_SIDED|95.0|-154.0|510.0|||Mixed Models Analysis|adjusting for baseline hemoglobin, age, sex, surgical vs. non-surgical admission, baseline ADLs||3-months post hospitalization||510|-154|0.27
72475022|NCT03568318|144475266|SUPERIORITY||Adjusted Response Rate Difference|24.5||||0.001|TWO_SIDED|95.0|10.4|38.7|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||38.7|10.4|0.001
72475023|NCT03568318|144475267|SUPERIORITY||Adjusted Response Rate Difference|19.8||||0.001|TWO_SIDED|95.0|7.8|31.8|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||31.8|7.8|0.001
72475024|NCT03568318|144475268|SUPERIORITY||Adjusted Response Rate Difference|6.2||||0.306|TWO_SIDED|95.0|-5.7|18.2|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||18.2|-5.7|0.306
72475025|NCT03568318|144475268|SUPERIORITY||Adjusted Response Rate Difference|-1.0||||0.855|TWO_SIDED|95.0|-11.2|9.3|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||9.3|-11.2|0.855
72475026|NCT03568318|144475269|SUPERIORITY||LS Mean Difference|-16.05|STANDARD_ERROR_OF_MEAN|11.956||0.18|TWO_SIDED|95.0|-39.59|7.48|||Mixed Effect Model Repeated Measurement|Mixed-effect model repeat measurement with Baseline, treatment, visit, treatment by visit interaction, and Baseline vIGA-AD category in the model.|Difference = Upadacitinib - Placebo|||7.48|-39.59|0.180
72475027|NCT03568318|144475269|SUPERIORITY||LS Mean Difference|-26.38|STANDARD_ERROR_OF_MEAN|11.986||0.029|TWO_SIDED|95.0|-49.97|-2.79|||Mixed Effect Model Repeated Measurement|Mixed-effect model repeat measurement with Baseline, treatment, visit, treatment by visit interaction, and Baseline vIGA-AD category in the model.|Difference = Upadacitinib - Placebo|||-2.79|-49.97|0.029
72475028|NCT03568318|144475270|SUPERIORITY||LS Mean Difference|-35.69|STANDARD_ERROR_OF_MEAN|5.354|<|0.001|TWO_SIDED|95.0|-46.28|-25.11|||Mixed Effect Model Repeated Measurement|Mixed-Effect Model Repeat Measurement with Baseline, treatment, visit, treatment by visit interaction, and Baseline vIGA-AD category in the model.|Difference = Upadacitinib - Placebo|||-25.11|-46.28|<0.001
72475029|NCT03568318|144475270|SUPERIORITY||LS Mean Difference|-24.37|STANDARD_ERROR_OF_MEAN|5.423|<|0.001|TWO_SIDED|95.0|-35.1|-13.65|||Mixed Effect Model Repeated Measurement|Mixed-Effect Model Repeat Measurement with Baseline, treatment, visit, treatment by visit interaction, and Baseline vIGA-AD category in the model.|Difference = Upadacitinib - Placebo|||-13.65|-35.10|<0.001
72475030|NCT01638429|144475273|SUPERIORITY_OR_OTHER|||||||0.16|||||||t-test, 2 sided|||Values compared in methane eradicators only pre- and post-treatment||||0.16
72475031|NCT01638429|144475275|SUPERIORITY_OR_OTHER|||||||0.028|||||||t-test, 2 sided|||P-value is comparing change in methane eradiacators before and after treatment to change in methane non-eradiacators before and after treatment||||0.028
72475032|NCT01638429|144475276|SUPERIORITY_OR_OTHER|||||||0.01|||||||t-test, 2 sided|||P-value is comparing change in methane eradiacators before and after treatment to change in methane non-eradiacators before and after treatment||||0.01
72475033|NCT01638429|144475277|SUPERIORITY_OR_OTHER|||||||0.97|||||||t-test, 2 sided|||Values compared in methane eradicators only pre- and post-treatment||||0.97
72475034|NCT01638429|144475277|SUPERIORITY_OR_OTHER|||||||0.85|||||||t-test, 2 sided|||Values compared in total study population pre- and post-treatment||||0.85
72475035|NCT01638429|144475278|SUPERIORITY_OR_OTHER|||||||0.61|||||||t-test, 2 sided|||Values compared in methane eradicators only pre- and post-treatment||||0.61
72398458|NCT05167734|144303320|SUPERIORITY||Odds Ratio (OR)|2.49||||0.12|TWO_SIDED|95.0|0.79|7.8|||proportional odds|adjusting for baseline hemoglobin, age, sex, and surgical vs. non-surgical admission|Estimates are odds ratios and correspond to the multiplicative increase in odds of higher value/score associated with active intervention|1-month post hospitalization||7.80|0.79|0.12
72475036|NCT01638429|144475278|SUPERIORITY_OR_OTHER|||||||0.45|||||||t-test, 2 sided|||Values compared in total study population pre- and post-treatment||||0.45
72398459|NCT05167734|144303320|SUPERIORITY||Odds Ratio (OR)|3.1||||0.07|TWO_SIDED|95.0|0.91|10.5|||proportional odds|proportional odds models adjusting for baseline hemoglobin, age, sex, and surgical vs. non-surgical admission|Estimates are odds ratios and correspond to the multiplicative increase in odds of higher value/score associated with active intervention|3-months post hospitalization||10.5|0.91|0.07
72475037|NCT01638429|144475279|SUPERIORITY_OR_OTHER|||||||0.018|||||||t-test, 2 sided|||Values compared in methane eradicators only pre- and post-treatment||||0.018
72475038|NCT01638429|144475279|SUPERIORITY_OR_OTHER|||||||0.14|||||||t-test, 2 sided|||Values compared in total study population pre- and post-treatment||||0.14
72475039|NCT01638429|144475280|SUPERIORITY_OR_OTHER|||||||0.43|||||||t-test, 2 sided|||Values compared in total study population pre- and post-treatment||||0.43
72475040|NCT01638429|144475280|SUPERIORITY_OR_OTHER|||||||0.44|||||||t-test, 2 sided|||Values compared in methane eradicators only pre- and post-treatment||||0.44
72475041|NCT01638429|144475281|SUPERIORITY_OR_OTHER|||||||0.13|||||||t-test, 2 sided|||Values compared in total study population pre- and post-treatment||||0.13
72475042|NCT01638429|144475281|SUPERIORITY_OR_OTHER|||||||0.25|||||||t-test, 2 sided|||Values compared in methane eradicators only pre- and post-treatment||||0.25
72475043|NCT01638429|144475282|SUPERIORITY_OR_OTHER|||||||0.29|||||||t-test, 2 sided|||Values compared in total study population pre- and post-treatment||||0.29
72475044|NCT01638429|144475282|SUPERIORITY_OR_OTHER|||||||0.27|||||||t-test, 2 sided|||Values compared in methane eradicators only pre- and post-treatment||||0.27
72475045|NCT01638429|144475283|SUPERIORITY_OR_OTHER|||||||0.22|||||||t-test, 2 sided|||Values compared in total study population pre- and post-treatment||||0.22
72475046|NCT01638429|144475283|SUPERIORITY_OR_OTHER|||||||0.059|||||||t-test, 2 sided|||Values compared in methane eradicators only pre- and post-treatment||||0.059
72475047|NCT01638429|144475284|SUPERIORITY_OR_OTHER|||||||0.33|||||||t-test, 2 sided|||Values compared in total study population pre- and post-treatment||||0.33
72475048|NCT01638429|144475284|SUPERIORITY_OR_OTHER|||||||0.075|||||||t-test, 2 sided|||Values compared in methane eradicators only pre- and post-treatment||||0.075
72475049|NCT00996476|144475291|SUPERIORITY_OR_OTHER||LS means difference|-2.4|||||TWO_SIDED|95.0|-2.83|-1.97|||ANCOVA||TMC435 50 mg minus PR48 control|Difference in least square (LS) mean change from baseline from the PR48 control group||-1.97|-2.83|
72398460|NCT05167734|144303321|SUPERIORITY||Odds Ratio (OR)|0.5||||0.29|TWO_SIDED|95.0|0.14|1.8|||proportional odds|proportional odds models adjusting for baseline hemoglobin, age, sex, and surgical vs. non-surgical admission|Estimates are odds ratios and correspond to the multiplicative increase in odds of higher value/score associated with active intervention|1-month post hospitalization for anxiety score||1.80|0.14|0.29
72398461|NCT05167734|144303321|SUPERIORITY||Odds Ratio (OR)|0.68||||0.57|TWO_SIDED|95.0|0.18|2.6|||proportional odds|proportional odds models adjusting for baseline hemoglobin, age, sex, and surgical vs. non-surgical admission|Estimates are odds ratios and correspond to the multiplicative increase in odds of higher value/score associated with active intervention|3-months post hospitalization for anxiety score||2.60|0.18|0.57
72475050|NCT00996476|144475291|SUPERIORITY_OR_OTHER||LS Means difference|-2.41|||||TWO_SIDED|95.0|-2.85|-1.98|||ANCOVA||TMC435 100 mg minus PR48 control|Difference in least square (LS) mean change from baseline from the PR48 control group||-1.98|-2.85|
72475051|NCT00996476|144475296|SUPERIORITY_OR_OTHER||Difference in percentage of participants|-24.6|||||TWO_SIDED|95.0|-58.3|11.8|||||PR48 control minus TMC12/PR24|The difference in the percentage of participants between The TMC12/PR24 50 mg treatment group and the PR48 control group||11.8|-58.3|
72475052|NCT00996476|144475296|SUPERIORITY_OR_OTHER||Difference in percentage of participants|-27.5|||||TWO_SIDED|95.0|-61.1|9.8|||||PR48 control minus TMC12/PR24|The difference in the percentage of participants between The TMC12/PR24 100 mg treatment group and the PR48 control group||9.8|-61.1|
72507364|NCT02433210|144546544|SUPERIORITY|Failed normality test|||||=|0.198||||||The p value was not adjusted for multiple comparisons and the difference was considered significant at the p\<0.05 level.|Wilcoxon (Mann-Whitney)|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||No significant difference||||=0.198
72507365|NCT02433210|144546544|SUPERIORITY||||||=|0.007||||||The p value was not adjusted for multiple comparisons and the difference was considered significant at the p\<0.05 level.|t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||Showed a significant difference||||=0.007
72398462|NCT05167734|144303321|SUPERIORITY||Odds Ratio (OR)|0.36||||0.12|TWO_SIDED|95.0|0.1|1.3|||proportional odds|proportional odds models adjusting for baseline hemoglobin, age, sex, and surgical vs. non-surgical admission|Estimates are odds ratios and correspond to the multiplicative increase in odds of higher value/score associated with active intervention|1-month post hospitalization for depression score||1.30|0.10|0.12
72398463|NCT05167734|144303321|SUPERIORITY||Odds Ratio (OR)|0.62||||0.48|TWO_SIDED|95.0|0.16|2.4|||proportional odds|proportional odds models adjusting for baseline hemoglobin, age, sex, and surgical vs. non-surgical admission|Estimates are odds ratios and correspond to the multiplicative increase in odds of higher value/score associated with active intervention|3-months post hospitalization for depression score||2.40|0.16|0.48
72475053|NCT00996476|144475296|SUPERIORITY_OR_OTHER||Difference in percentage of participants|-23.3|||||TWO_SIDED|95.0|-59.9|19.4|||||PR48 control minus TMC24/PR24|The difference in the percentage of participants between The TMC24/PR24 50 mg treatment group and the PR48 control group||19.4|-59.9|
72475054|NCT00996476|144475296|SUPERIORITY_OR_OTHER||Difference in percentage of participants|-32.3|||||TWO_SIDED|95.0|-66.6|8.3|||||PR48 control minus TMC24/PR24|The difference in the percentage of participants between The TMC24/PR24 100 mg treatment group and the PR48 control group||8.3|-66.6|
72398464|NCT05167734|144303322|SUPERIORITY||Odds Ratio (OR)|1.48||||0.56|TWO_SIDED|95.0|0.39|5.6|||proportional odds|proportional odds models adjusting for baseline hemoglobin, age, sex, and surgical vs. non-surgical admission|Estimates are odds ratios and correspond to the multiplicative increase in odds of higher value/score associated with active intervention|1-month post hospitalization||5.60|0.39|0.56
72398465|NCT05167734|144303322|SUPERIORITY||Odds Ratio (OR)|9.16||||0.02|TWO_SIDED|95.0|1.4|59.9|||proportional odds|proportional odds models adjusting for baseline hemoglobin, age, sex, and surgical vs. non-surgical admission|Estimates are odds ratios and correspond to the multiplicative increase in odds of higher value/score associated with active intervention|3-months post hospitalization||59.9|1.40|0.02
72398466|NCT05167734|144303323|SUPERIORITY||Odds Ratio (OR)|0.16||||0.09|TWO_SIDED|95.0|0.02|1.4|||Regression, Logistic|adjusting for baseline hemoglobin, age, sex, and surgical vs. non-surgical admission|Estimates are odds ratios and correspond to the multiplicative increase in odds of higher value/score associated with active intervention|||1.40|0.02|0.09
72398467|NCT05167734|144303325|SUPERIORITY||Odds Ratio (OR)|0.73||||0.48|TWO_SIDED|95.0|0.3|1.8|||Regression, Logistic|logistic models adjusting for baseline hemoglobin, age, sex, and surgical vs. non-surgical admission|Estimates are odds ratios and correspond to the multiplicative increase in odds for the given event associated with intervention associated with active intervention|3-months post hospitalization||1.80|0.30|0.48
72398468|NCT05167734|144303326|SUPERIORITY||Odds Ratio (OR)|2.13||||0.54|TWO_SIDED|95.0|0.19|24.0|||Regression, Logistic|logistic models adjusting for baseline hemoglobin, age, sex, and surgical vs. non-surgical admission|Estimates are odds ratios and correspond to the multiplicative increase in odds for the given event associated with intervention associated with active intervention|3-months post hospitalization||24.0|0.19|0.54
72475055|NCT05540717|144475305|SUPERIORITY||relative difference (%)|-20.25||||0.00048|TWO_SIDED|95.0|-31.0|-9.49|||Mixed Models Analysis|||Linear mixed model using treatment group as fixed effect and pooled geographical region as random effect||-9.49|-31.0|0.00048
72507366|NCT02433210|144546544|SUPERIORITY||||||=|0.202||||||The p value was not adjusted for multiple comparisons and the difference was considered significant at the p\<0.05 level.|t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||No significant difference||||=0.202
72507367|NCT02433210|144546544|SUPERIORITY||||||=|0.54||||||The p value was not adjusted for multiple comparisons and the difference was considered significant at the p\<0.05 level.|t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||No significant difference||||=0.540
72398469|NCT02604212|144303330|SUPERIORITY||LS Mean Difference|-0.042|STANDARD_ERROR_OF_MEAN|0.102||0.6815|TWO_SIDED|95.0|-0.243|0.159|||MMRM|||||0.159|-0.243|0.6815
72398470|NCT02604212|144303330|SUPERIORITY||LS Mean Difference|-0.438|STANDARD_ERROR_OF_MEAN|0.101|<|0.0001|TWO_SIDED|95.0|-0.638|-0.237|||MMRM|||||-0.237|-0.638|<.0001
72507368|NCT02433210|144546545|SUPERIORITY||||||=|0.204|||||||Wilcoxon (Mann-Whitney)|||||||=0.204
72507369|NCT02433210|144546545|SUPERIORITY||||||=|0.234|||||||Wilcoxon (Mann-Whitney)|||||||=0.234
72475056|NCT05540717|144475306|SUPERIORITY||relative difference (%)|-20.2||||0.00032|TWO_SIDED|95.0|-30.13|-10.27|||Mixed Models Analysis|Linear mixed model using treatment group as fixed effect and pooled geographical region as random effect||Linear mixed model using treatment group as fixed effect and pooled geographical region as random effect||-10.27|-30.13|0.00032
72475057|NCT05540717|144475307|SUPERIORITY|Linear mixed model using treatment group as fixed effect and pooled geographical region as random effect|relative difference (%)|-26.54||||0.0008|TWO_SIDED|95.0|-41.15|-11.94|||Mixed Models Analysis|||Comparison of dMS of CSMS on peak GPS||-11.94|-41.15|0.00080
72475058|NCT05540717|144475307|SUPERIORITY|Linear mixed model using treatment group as fixed effect and pooled geographical region as random effect.|relative difference (%)|-26.6||||0.00031|TWO_SIDED|95.0|-40.49|-12.72|||Mixed Models Analysis|||Comparison of dMS of CSMS on entire GPS||-12.72|-40.49|0.00031
72475059|NCT05540717|144475308|SUPERIORITY|Linear mixed model using treatment group as fixed effect and pooled geographical region as random effect|relative difference (%)|-16.35||||0.00223|TWO_SIDED|95.0|-26.27|-6.44|||Mixed Models Analysis|||Comparison of dSS of CSMS on peak GPS||-6.44|-26.27|0.00223
72475060|NCT05540717|144475308|SUPERIORITY|Linear mixed model using treatment group as fixed effect and pooled geographical region as random effect|relative difference (%)|-16.58||||0.00076|TWO_SIDED|95.0|||||Mixed Models Analysis|||Comparison of dSS of CSMS on entire GPS||||0.00076
72475061|NCT05540717|144475309|SUPERIORITY||Mean Difference (Final Values)|-0.49||||0.00032|TWO_SIDED|95.0|-0.76|-0.23|||Mixed Models Analysis|Linear mixed model using treatment group as fixed effect, Baseline total RQLQ score as covariate and pooled geographical region as random effect||Average Total RQLQ Score During Peak GPS||-0.23|-0.76|0.00032
72475062|NCT05540717|144475310|SUPERIORITY||Mean Difference (Final Values)|3.99|||<|1e-05|TWO_SIDED|95.0|3.28|4.7|||Mixed Models Analysis|||Change from baseline to Visit 7 of serum grass-specific IgG4 \[mg/L\]||4.7|3.28|<0.00001
72475063|NCT05540717|144475311|SUPERIORITY||Odds Ratio (OR)|1.254||||0.10846|TWO_SIDED|95.0|0.951|1.652|||Regression, Logistic|The probability of a well day was calculated using a generalized estimating equation (GEE) or similar approaches as appropriate.||Probability of Well Days During Peak (truncated) GPS||1.652|0.951|0.10846
72475064|NCT01470001|144475344|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|17.7||||0.1135|TWO_SIDED|95.0|-4.3|39.7|||Mixed Models Analysis|mixed model with repeated measurements||A planned sample size of 56 subjects per group provided 80% power to detect a difference of 0.25 between post void dribbling response rates (assumed to be 0.35 under the null hypothesis and 0.60 under the alternative hypothesis) at a one-sided 0.05 significance level.||39.7|-4.3|.1135
72475065|NCT01470001|144475345|SUPERIORITY_OR_OTHER||Mean Difference (Net)|14.3||||0.0919|TWO_SIDED|95.0|-2.3|30.8|||Regression, Logistic|logistic regression with repeated measurements||||30.8|-2.3|.0919
72475066|NCT01470001|144475346|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.7||||0.44|TWO_SIDED|95.0|-17.5|6.2||p value was adjusted for age.|ANCOVA||we calculated the estimated difference in change between the placebo and treatment groups.|the difference in change between the groups was measured||6.2|-17.5|0.44
72475067|NCT00734591|144475367|SUPERIORITY_OR_OTHER||Exact method|2.81|||||TWO_SIDED|95.0|0.5|28.46|||||Incidence density ratio confidence interval derived from exact methods utilizing exact binomial limits and ratio of exposures.|||28.46|0.50|
72398471|NCT02604212|144303330|SUPERIORITY||LS Mean Difference|-0.396|STANDARD_ERROR_OF_MEAN|0.088|<|0.0001|TWO_SIDED|95.0|-0.569|-0.223|||MMRM|||||-0.223|-0.569|<.0001
72475068|NCT00734591|144475368|SUPERIORITY_OR_OTHER||Exact method|2.29|||||TWO_SIDED|95.0|0.37|24.01|||||Incidence density ratio confidence interval derived from exact methods utilizing exact binomial limits and ratio of exposures.|||24.01|0.37|
72475069|NCT00734591|144475369|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.81|||||TWO_SIDED|95.0|0.6|1.1||||||||1.10|0.60|
72475070|NCT00734591|144475370|SUPERIORITY_OR_OTHER||Exact method|3.75|||||TWO_SIDED|95.0|1.01|20.68|||||Incidence density ratio confidence interval derived from exact methods utilizing exact binomial limits and ratio of exposures.|||20.68|1.01|
72475071|NCT00338962|144475377|SUPERIORITY_OR_OTHER|||||||0|TWO_SIDED|||||Bonferonni adjustments were applied. Mixed effects models were used to assess changes in PTSD symptoms over time.|Mixed Models Analysis|F=49.633||||||0.00
72475072|NCT00338962|144475379|SUPERIORITY_OR_OTHER|||||||0.007|TWO_SIDED||||||ANOVA|||Gastrointestinal symptoms compared||||0.007
72475073|NCT02310100|144475396|OTHER|This is a one-group comparison to a performance goal.|binomial proportion|0.673||||0.0008|ONE_SIDED|95.0|0.608||||Exact binomial|||H0: PE ≤ 54.9% Ha: PE \> 54.9% Where PE is the primary effectiveness endpoint rate.|||0.608|0.0008
72475074|NCT02310100|144475397|OTHER|One group comparison to a performance goal.|binomial proportion|0.081||||0.0013|ONE_SIDED|95.0||0.124|||Exact binomial|||H0: PS ≥ 16.2% Ha: PS \< 16.2% where PS is the primary safety endpoint rate||0.124||0.0013
72475075|NCT00688870|144475401|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Exact, unconditional, 2-sided 95% CI for the difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|-1.2|||||TWO_SIDED|95.0|-6.8|3.3|||Chan and Zhang|||Common serotypes - serotype 4||3.3|-6.8|
72475076|NCT00688870|144475401|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Exact, unconditional, 2-sided 95% CI for the difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|0.0|||||TWO_SIDED|95.0|-4.6|4.3|||Chan and Zhang|||Common serotypes - serotype 6B||4.3|-4.6|
72475077|NCT00688870|144475401|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Exact, unconditional, 2-sided 95% CI for the difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|-1.2|||||TWO_SIDED|95.0|-6.8|3.3|||Chan and Zhang|||Common serotypes - serotype 9V||3.3|-6.8|
72475078|NCT00688870|144475401|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Exact, unconditional, 2-sided 95% CI for the difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|0.0|||||TWO_SIDED|95.0|-4.6|4.3|||Chan and Zhang|||Common serotypes - serotype 14||4.3|-4.6|
72507370|NCT02433210|144546545|SUPERIORITY||||||=|0.015||||||The p value was not adjusted for multiple comparisons and the difference was considered significant at the \<0.050 level.|t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either then the non-parametric Mann-Whitney Rank Sum Test was used.||||||=0.015
72398472|NCT02604212|144303331|SUPERIORITY||LS Mean Difference|-0.208|STANDARD_ERROR_OF_MEAN|0.083||0.0131|TWO_SIDED|95.0|-0.372|-0.044|||MMRM|||Day 15||-0.044|-0.372|0.0131
72398473|NCT02604212|144303331|SUPERIORITY||LS Mean Difference|-0.247|STANDARD_ERROR_OF_MEAN|0.084||0.0036|TWO_SIDED|95.0|-0.412|-0.082|||MMRM|||Day 15||-0.082|-0.412|0.0036
72398474|NCT02604212|144303331|SUPERIORITY||LS Mean Difference|-0.039|STANDARD_ERROR_OF_MEAN|0.077||0.6136|TWO_SIDED|95.0|-0.192|0.113|||MMRM|||Day 15||0.113|-0.192|0.6136
72398475|NCT02604212|144303331|SUPERIORITY||LS Mean Difference|-0.085|STANDARD_ERROR_OF_MEAN|0.083||0.3104|TWO_SIDED|95.0|-0.249|0.08|||MMRM|||Day 29||0.080|-0.249|0.3104
72398476|NCT02604212|144303331|SUPERIORITY||LS Mean Difference|-0.174|STANDARD_ERROR_OF_MEAN|0.084||0.0401|TWO_SIDED|95.0|-0.34|-0.008|||MMRM|||Day 29||-0.008|-0.340|0.0401
72398477|NCT02604212|144303331|SUPERIORITY||LS Mean Difference|-0.089|STANDARD_ERROR_OF_MEAN|0.077||0.2494|TWO_SIDED|95.0|-0.242|0.063|||MMRM|||Day 29||0.063|-0.242|0.2494
72398478|NCT02604212|144303331|SUPERIORITY||LS Mean Difference|-0.211|STANDARD_ERROR_OF_MEAN|0.085||0.0149|TWO_SIDED|95.0|-0.38|-0.042|||MMRM|||Day 43||-0.042|-0.380|0.0149
72475079|NCT00688870|144475401|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Exact, unconditional, 2-sided 95% CI for the difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|0.0|||||TWO_SIDED|95.0|-4.6|4.3|||Chan and Zhang|||Common serotypes - serotype 18C||4.3|-4.6|
72475080|NCT00688870|144475401|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Exact, unconditional, 2-sided 95% CI for the difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|-1.2|||||TWO_SIDED|95.0|-6.8|3.3|||Chan and Zhang|||Common serotypes - serotype 19F||3.3|-6.8|
72623100|NCT04101331|144776617|OTHER|||||||0.537||||||One-sided p-value.|Exact binomial test|Exact binomial test compares versus a proportion of 0.25.||||||0.537
72398479|NCT02604212|144303331|SUPERIORITY||LS Mean Difference|-0.319|STANDARD_ERROR_OF_MEAN|0.086||0.0003|TWO_SIDED|95.0|-0.489|-0.149|||MMRM|||Day 43||-0.149|-0.489|0.0003
72398480|NCT02604212|144303331|SUPERIORITY||LS Mean Difference|-0.108|STANDARD_ERROR_OF_MEAN|0.078||0.1655|TWO_SIDED|95.0|-0.262|0.045|||MMRM|||Day 29||0.045|-0.262|0.1655
72398481|NCT02604212|144303331|SUPERIORITY||LS Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.088||0.0889|TWO_SIDED|95.0|-0.324|0.023|||MMRM|||Day 57||0.023|-0.324|0.0889
72398482|NCT02604212|144303331|SUPERIORITY||LS Mean Difference|-0.322|STANDARD_ERROR_OF_MEAN|0.088||0.0004|TWO_SIDED|95.0|-0.497|-0.147|||MMRM|||Day 57||-0.147|-0.497|0.0004
72398483|NCT02604212|144303331|SUPERIORITY||LS Mean Difference|-0.172|STANDARD_ERROR_OF_MEAN|0.078||0.0298|TWO_SIDED|95.0|-0.326|-0.017|||MMRM|||Day 57||-0.017|-0.326|0.0298
72398484|NCT02604212|144303331|SUPERIORITY||LS Mean Difference|-0.184|STANDARD_ERROR_OF_MEAN|0.089||0.0415|TWO_SIDED|95.0|-0.361|-0.007|||MMRM|||Day 71||-0.007|-0.361|0.0415
72398485|NCT02604212|144303331|SUPERIORITY||LS Mean Difference|-0.441|STANDARD_ERROR_OF_MEAN|0.091|<|0.0001|TWO_SIDED|95.0|-0.62|-0.261|||MMRM|||Day 71||-0.261|-0.620|<.0001
72398486|NCT02604212|144303331|SUPERIORITY||LS Mean Difference|-0.257|STANDARD_ERROR_OF_MEAN|0.079||0.0015|TWO_SIDED|95.0|-0.413|-0.1|||MMRM|||Day 71||-0.100|-0.413|0.0015
72398487|NCT02604212|144303331|SUPERIORITY||LS Mean Difference|-0.086|STANDARD_ERROR_OF_MEAN|0.092||0.351|TWO_SIDED|95.0|-0.268|0.096|||MMRM|||Day 85||0.096|-0.268|0.3510
72623101|NCT04378153|144776663|SUPERIORITY||Difference in % Participants|2.17||||0.1215|TWO_SIDED|95.0|-0.7|5.7|||Fisher Exact||Confidence interval calculated using the Newcombe-Wilson method without continuity correction. Direction of difference is Discontinue - Continue.|Null hypothesis: proportion of participants changing assigned regimen is the same in Discontinue and Continue arms.||5.7|-0.7|0.1215
72623102|NCT00488293|144776664|SUPERIORITY_OR_OTHER|||||||0.66|TWO_SIDED||||||t-test, 2 sided|||||||0.66
72623103|NCT00488293|144776665|SUPERIORITY_OR_OTHER|||||||0.88|TWO_SIDED||||||Chi-squared|||||||0.88
72398488|NCT02604212|144303331|SUPERIORITY||LS Mean Difference|-0.404|STANDARD_ERROR_OF_MEAN|0.094|<|0.0001|TWO_SIDED|95.0|-0.59|-0.219|||MMRM|||Day 85||-0.219|-0.590|<.0001
72398489|NCT02604212|144303331|SUPERIORITY||LS Mean Difference|-0.318|STANDARD_ERROR_OF_MEAN|0.082||0.0002|TWO_SIDED|95.0|-0.481|-0.156|||MMRM|||Day 85||-0.156|-0.481|0.0002
72398490|NCT02604212|144303331|SUPERIORITY||LS Mean Difference|-0.151|STANDARD_ERROR_OF_MEAN|0.096||0.1198|TWO_SIDED|95.0|-0.341|0.04|||MMRM|||Day 99||0.040|-0.341|0.1198
72398491|NCT02604212|144303331|SUPERIORITY||LS Mean Difference|-0.516|STANDARD_ERROR_OF_MEAN|0.097|<|0.0001|TWO_SIDED|95.0|-0.708|-0.325|||MMRM|||Day 99||-0.325|-0.708|<.0001
72398492|NCT02604212|144303331|SUPERIORITY||LS Mean Difference|-0.366|STANDARD_ERROR_OF_MEAN|0.085|<|0.0001|TWO_SIDED|95.0|-0.535|-0.197|||MMRM|||Day 99||-0.197|-0.535|<.0001
72398493|NCT02604212|144303332|SUPERIORITY|||||||0.0867|||||||Fisher Exact|||||||0.0867
72398494|NCT02604212|144303332|SUPERIORITY|||||||0.6285|||||||Fisher Exact|||||||0.6285
72398495|NCT02604212|144303332|SUPERIORITY|||||||0.7214|||||||Fisher Exact|||||||0.7214
72398496|NCT02604212|144303333|SUPERIORITY|||||||0.0325|||||||Fisher Exact|||||||0.0325
72398497|NCT02604212|144303333|SUPERIORITY|||||||0.1409|||||||Fisher Exact|||||||0.1409
72398498|NCT02604212|144303333|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.0000
72398499|NCT02604212|144303334|SUPERIORITY|||||||0.0824|||||||Fisher Exact|||||||0.0824
72398500|NCT02604212|144303334|SUPERIORITY|||||||0.2217|||||||Fisher Exact|||||||0.2217
72398501|NCT02604212|144303334|SUPERIORITY|||||||0.1409|||||||Fisher Exact|||||||0.1409
72398502|NCT02604212|144303335|SUPERIORITY|||||||0.0625|||||||Fisher Exact|||||||0.0625
72398503|NCT02604212|144303335|SUPERIORITY|||||||0.0684|||||||Fisher Exact|||||||0.0684
72398504|NCT02604212|144303335|SUPERIORITY|||||||0.2105|||||||Fisher Exact|||||||0.2105
72398505|NCT02604212|144303336|SUPERIORITY|||||||0.175|||||||Fisher Exact|||||||0.1750
72398506|NCT02604212|144303336|SUPERIORITY|||||||0.0229|||||||Fisher Exact|||||||0.0229
72398507|NCT02604212|144303336|SUPERIORITY|||||||0.0294|||||||Fisher Exact|||||||0.0294
72398508|NCT02604212|144303337|SUPERIORITY|||||||0.4615|||||||Fisher Exact|||||||0.4615
72398509|NCT02604212|144303337|SUPERIORITY|||||||0.0508|||||||Fisher Exact|||||||0.0508
72398510|NCT02604212|144303337|SUPERIORITY|||||||0.0769|||||||Fisher Exact|||||||0.0769
72398511|NCT02604212|144303338|SUPERIORITY|||||||0.0699|||||||Fisher Exact|||||||0.0699
72398512|NCT02604212|144303338|SUPERIORITY|||||||0.0179|||||||Fisher Exact|||||||0.0179
72398513|NCT02604212|144303338|SUPERIORITY|||||||0.043|||||||Fisher Exact|||||||0.0430
72623104|NCT00488293|144776666|SUPERIORITY_OR_OTHER|||||||0.39|TWO_SIDED||||||t-test, 2 sided|||||||0.39
72623105|NCT00488293|144776667|SUPERIORITY_OR_OTHER|||||||0.22|TWO_SIDED||||||t-test, 2 sided|||||||0.22
72398514|NCT02604212|144303339|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.0000
72398515|NCT02604212|144303339|SUPERIORITY|||||||0.0849|||||||Fisher Exact|||||||0.0849
72398516|NCT02604212|144303339|SUPERIORITY|||||||0.0849|||||||Fisher Exact|||||||0.0849
72475081|NCT00688870|144475401|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Exact, unconditional, 2-sided 95% CI for the difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|-5.0|||||TWO_SIDED|95.0|-12.3|-0.3|||Chan and Zhang|||Common serotypes - serotype 23F||-0.3|-12.3|
72475082|NCT00688870|144475401|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Exact, unconditional, 2-sided 95% CI for the difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|96.3|||||TWO_SIDED|95.0|89.4|99.2|||Chan and Zhang|||Additional serotypes - serotype 1||99.2|89.4|
72475083|NCT00688870|144475401|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Exact, unconditional, 2-sided 95% CI for the difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|95.1|||||TWO_SIDED|95.0|87.7|98.6|||Chan and Zhang|||Additional serotypes - serotype 3||98.6|87.7|
72475084|NCT00688870|144475401|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Exact, unconditional, 2-sided 95% CI for the difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|37.2|||||TWO_SIDED|95.0|26.2|48.9|||Chan and Zhang|||Additional serotypes - serotype 5||48.9|26.2|
72475085|NCT00688870|144475401|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Exact, unconditional, 2-sided 95% CI for the difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|22.9|||||TWO_SIDED|95.0|14.4|33.4|||Chan and Zhang|||Additional serotypes - serotype 6A||33.4|14.4|
72475086|NCT00688870|144475401|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Exact, unconditional, 2-sided 95% CI for the difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|97.6|||||TWO_SIDED|95.0|91.6|99.7|||Chan and Zhang|||Additional serotypes - serotype 7F||99.7|91.6|
72475087|NCT00688870|144475401|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Exact, unconditional, 2-sided 95% CI for the difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|0.0|||||TWO_SIDED|95.0|-4.6|4.5|||Chan and Zhang|||Additional serotypes - serotype 19A||4.5|-4.6|
72475088|NCT00688870|144475402|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Exact, unconditional, 2-sided 95% CI for the difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|-1.3|||||TWO_SIDED|95.0|-6.9|3.1|||Chan and Zhang|||Common serotypes - serotype 4||3.1|-6.9|
72475089|NCT00688870|144475402|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Exact, unconditional, 2-sided 95% CI for the difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|0.0|||||TWO_SIDED|95.0|-4.6|4.4|||Chan and Zhang|||Common serotypes - serotype 6B||4.4|-4.6|
72475090|NCT00688870|144475402|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Exact, unconditional, 2-sided 95% CI for the difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|-1.3|||||TWO_SIDED|95.0|-6.9|3.1|||Chan and Zhang|||Common serotypes - serotype 9V||3.1|-6.9|
72475091|NCT00688870|144475402|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Exact, unconditional, 2-sided 95% CI for the difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|0.0|||||TWO_SIDED|95.0|-4.6|4.4|||Chan and Zhang|||Common serotypes - serotype 14||4.4|-4.6|
72475092|NCT00688870|144475402|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Exact, unconditional, 2-sided 95% CI for the difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|0.0|||||TWO_SIDED|95.0|-4.6|4.4|||Chan and Zhang|||Common serotypes - serotype 18C||4.4|-4.6|
72475093|NCT00688870|144475402|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Exact, unconditional, 2-sided 95% CI for the difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|-1.3|||||TWO_SIDED|95.0|-6.9|3.1|||Chan and Zhang|||Common serotypes - serotype 19F||3.1|-6.9|
72507371|NCT02433210|144546545|SUPERIORITY||||||=|0.413||||||The p value was not adjusted for multiple comparisons and the difference was considered significant at the p\<0.05 level.|Wilcoxon (Mann-Whitney)|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.413
72398517|NCT01119131|144303349|SUPERIORITY_OR_OTHER|||||||0.699|TWO_SIDED||||||ANOVA|||||||0.699
72398518|NCT01119131|144303350|SUPERIORITY_OR_OTHER|||||||0.308|TWO_SIDED||||||ANOVA|||||||0.308
72475094|NCT00688870|144475402|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Exact, unconditional, 2-sided 95% CI for the difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|0.0|||||TWO_SIDED|95.0|-4.6|4.4|||Chan and Zhang|||Common serotypes - serotype 23F||4.4|-4.6|
72566098|NCT04146363|144662935|SUPERIORITY||LS Mean Difference (Final Values)|-30.42|STANDARD_ERROR_OF_MEAN|3.915|<|1e-06|TWO_SIDED|95.0|-38.1|-22.7|||ANCOVA|||||-22.7|-38.1|<0.000001
72398519|NCT01119131|144303351|SUPERIORITY_OR_OTHER|||||||0.419|TWO_SIDED||||||ANOVA|||||||0.419
72398520|NCT01119131|144303352|SUPERIORITY_OR_OTHER|||||||0.253|TWO_SIDED||||||ANOVA|||||||0.253
72398521|NCT01119131|144303353|SUPERIORITY_OR_OTHER|||||||0.793|TWO_SIDED||||||ANOVA|||||||0.793
72398522|NCT01119131|144303355|SUPERIORITY_OR_OTHER|||||||0.949|TWO_SIDED||||||ANOVA|||||||0.949
72398523|NCT01119131|144303356|SUPERIORITY_OR_OTHER|||||||0.957|TWO_SIDED||||||ANOVA|||||||0.957
72398524|NCT01341964|144303357|SUPERIORITY||Median Difference (Final Values)|0.05||||0.66|TWO_SIDED||||||t-test, 2 sided|not normally distributed, values were log-transformed.||||||0.66
72398525|NCT00840294|144303375|SUPERIORITY_OR_OTHER|||||||0.33|||||||t-test, 2 sided|||||||0.33
72398526|NCT00883116|144303391|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.3||||0.0397|TWO_SIDED|95.0|1.0|1.7|||Log Rank|||||1.7|1.0|0.0397
72398527|NCT00883116|144303392|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.0||||0.8011|TWO_SIDED|95.0|0.8|1.3|||Log Rank|||||1.3|0.8|0.8011
72398528|NCT04501666|144303401|SUPERIORITY||Strata adjusted percentage difference|40.1|||<|0.0001|TWO_SIDED|95.0|29.4|50.8||A 2-sided p-value was derived from Cochran-Mantel-Haenszel (CMH) test using the randomized stratification variables (analysis center and body weight at randomization \[\< 90 kg, \>= 90 kg\]). Threshold of significance at 0.05.|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measures were reported and continued when previous outcome measure was statistically significant at two-sided 0.05.||50.8|29.4|< 0.0001
72398529|NCT04501666|144303402|SUPERIORITY||Strata adjusted percentage difference|14.6||||0.0025|TWO_SIDED|95.0|6.7|22.6||A 2-sided p-value was derived from Cochran-Mantel-Haenszel (CMH) test using the randomized stratification variables (analysis center and body weight at randomization \[\< 90 kg, \>= 90 kg\]). Threshold of significance at 0.05.|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measures were reported and continued when previous outcome measure was statistically significant at two-sided 0.05.||22.6|6.7|0.0025
72398530|NCT04501666|144303404|SUPERIORITY||Strata adjusted percentage difference|31.7|||<|0.0001|TWO_SIDED|95.0|23.0|40.4||A 2-sided p-value was derived from CMH test using the randomized stratification variables (analysis center and body weight at randomization \[\< 90 kg, \>= 90 kg\]). Threshold of significance at 0.05.|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measures were reported and continued when previous outcome measure was statistically significant at two-sided 0.05.||40.4|23.0|< 0.0001
72398531|NCT04501666|144303405|SUPERIORITY||Strata adjusted percentage difference|30.5|||<|0.0001|TWO_SIDED|95.0|22.3|38.7||A 2-sided p-value was derived from CMH test using the randomized stratification variables (analysis center and body weight at randomization \[\< 90 kg, \>= 90 kg\]). Threshold of significance at 0.05.|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measures were reported and continued when previous outcome measure was statistically significant at two-sided 0.05.||38.7|22.3|< 0.0001
72398532|NCT04501666|144303406|SUPERIORITY||Strata adjusted percentage difference|38.0|||<|0.0001|TWO_SIDED|95.0|27.8|48.2||A 2-sided p-value was derived from CMH test using the randomized stratification variables (analysis center and body weight at randomization \[\< 90 kg, \>= 90 kg\]). Threshold of significance at 0.05.|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measures were reported and continued when previous outcome measure was statistically significant at two-sided 0.05.||48.2|27.8|< 0.0001
72398533|NCT04501666|144303407|SUPERIORITY||Strata adjusted percentage difference|22.7|||<|0.0001|TWO_SIDED|95.0|14.7|30.7||A 2-sided p-value was derived from CMH test using the randomized stratification variables (analysis center and body weight at randomization \[\< 90 kg, \>= 90 kg\]). Threshold of significance at 0.05.|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measures were reported and continued when previous outcome measure was statistically significant at two-sided 0.05.||30.7|14.7|< 0.0001
72475095|NCT00688870|144475402|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Exact, unconditional, 2-sided 95% CI for the difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|95.0|||||TWO_SIDED|95.0|87.7|98.6|||Chan and Zhang|||Additional serotypes - serotype 1||98.6|87.7|
72475096|NCT00688870|144475402|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Exact, unconditional, 2-sided 95% CI for the difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|82.5|||||TWO_SIDED|95.0|72.0|90.1|||Chan and Zhang|||Additional serotypes - serotype 3||90.1|72.0|
72475097|NCT00688870|144475402|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Exact, unconditional, 2-sided 95% CI for the difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|9.6|||||TWO_SIDED|95.0|3.8|18.1|||Chan and Zhang|||Additional serotypes - serotype 5||18.1|3.8|
72475098|NCT00688870|144475402|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Exact, unconditional, 2-sided 95% CI for the difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|0.0|||||TWO_SIDED|95.0|-4.6|4.4|||Chan and Zhang|||Additional serotypes - serotype 6A||4.4|-4.6|
72507372|NCT02433210|144546545|SUPERIORITY||||||=|0.314||||||The p value was not adjusted for multiple comparisons and the difference was considered significant at the p\<0.05 level.|t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.314
72507373|NCT02433210|144546545|SUPERIORITY||||||=|0.769||||||The p value was not adjusted for multiple comparisons and the difference was considered significant at the p\<0.05 level.|t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.769
72507374|NCT02433210|144546546|SUPERIORITY||||||=|0.376|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.376
72566099|NCT04146363|144662936|SUPERIORITY||Risk Difference (RD)|32.9|||<|1e-06|TWO_SIDED|95.0|24.6|41.3|||Cochran-Mantel-Haenszel|||||41.3|24.6|<0.000001
72398534|NCT04501666|144303408|SUPERIORITY||Strata adjusted percentage difference|18.7|||<|0.0001|TWO_SIDED|95.0|12.3|25.0||A 2-sided p-value was derived from CMH test using the randomized stratification variables (analysis center and body weight at randomization \[\< 90 kg, \>= 90 kg\]). Threshold of significance at 0.05.|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measures were reported and continued when previous outcome measure was statistically significant at two-sided 0.05.||25.0|12.3|< 0.0001
72398535|NCT01722071|144303413|SUPERIORITY_OR_OTHER|||||||0.89|TWO_SIDED|||||The a priori threshold for statistical significance was p\<0.05.|t-test, 2 sided|||A two-sided paired t-test was performed to determine whether oxytocin administration was associated with reward-related BOLD signal changes (within the Nucleus Accumbens \[Bilateral\]). For the group of 18 participants, BOLD signal activity was compared between oxytocin and placebo scanning days.||||0.890
72623106|NCT00488293|144776668|SUPERIORITY_OR_OTHER|||||||0.81|TWO_SIDED||||||t-test, 2 sided|||||||0.81
72475099|NCT00688870|144475402|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Exact, unconditional, 2-sided 95% CI for the difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|93.8|||||TWO_SIDED|95.0|86.0|97.9|||Chan and Zhang|||Additional serotypes - serotype 7F||97.9|86.0|
72475100|NCT00688870|144475402|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Exact, unconditional, 2-sided 95% CI for the difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|1.2|||||TWO_SIDED|95.0|-3.4|6.5|||Chan and Zhang|||Additional serotypes - serotype 19A||6.5|-3.4|
72475101|NCT00688870|144475403|SUPERIORITY_OR_OTHER_LEGACY||ratio of GMCs|0.62|||||TWO_SIDED|95.0|0.5|0.78|||||Confidence intervals for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC-7vPnC reference).|Common serotypes - serotype 4||0.78|0.50|
72398536|NCT01722071|144303413|SUPERIORITY_OR_OTHER|||||||0.422|TWO_SIDED|||||The a priori threshold for statistical significance was p\<0.05.|t-test, 2 sided|||A two-sided paired t-test was performed to determine whether oxytocin administration was associated with reward-related BOLD signal changes (within the Nucleus Accumbens \[Bilateral\]). For the group of 8 participants, BOLD signal activity was compared between oxytocin and placebo scanning days.||||0.422
72398537|NCT01722071|144303413|SUPERIORITY_OR_OTHER|||||||0.814|TWO_SIDED|||||The a priori threshold for statistical significance was p\<0.05.|t-test, 2 sided|||A two-sided paired t-test was performed to determine whether oxytocin administration was associated with reward-related BOLD signal changes (within the Nucleus Accumbens \[Bilateral\]). For the group of 10 participants, BOLD signal activity was compared between oxytocin and placebo scanning days.||||0.814
72398538|NCT00553150|144303437|SUPERIORITY_OR_OTHER_LEGACY||Maximum Tolerated Dose (mg)|70.0|||||TWO_SIDED|||||||||||||
72398539|NCT03061331|144303443|SUPERIORITY||Least Squares Mean Difference|0.1||||0.9277|TWO_SIDED|95.0|-2.5|2.7|||Mixed Model Repeated Measure (MMRM)|||||2.7|-2.5|0.9277
72398540|NCT01686633|144303454|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.108|||<|0.001|TWO_SIDED|95.0|0.045|0.171|||ANCOVA|||||0.171|0.045|<0.001
72507375|NCT02433210|144546546|SUPERIORITY|||||||1||||||The p value was not adjusted for multiple comparisons and the difference was considered significant at the p\<0.05 level.|Wilcoxon (Mann-Whitney)|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||1.000
72507376|NCT02433210|144546546|SUPERIORITY|||||||0.713|||||||Wilcoxon (Mann-Whitney)|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||0.713
72507377|NCT02433210|144546546|SUPERIORITY||||||=|0.424|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.424
72398541|NCT01686633|144303454|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.024|||||TWO_SIDED|95.0|-0.037|0.086||||||||0.086|-0.037|
72398542|NCT01765153|144303484|SUPERIORITY_OR_OTHER|||||||0.04366667|||||||t-test, 2 sided|||||||0.04366667
72398543|NCT00319644|144303530|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|20.0||||0.26||95.0|||||Chi-squared|||The chi-square test(or Fisher exact test where needed) was used to compare proportions with dichotomous variables. The Student-t test was used for quantitative variables woth normal distribution, and Mann-Whitney-U test was used for data not normally distributed.||||0.26
72398544|NCT00312494|144303611|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1077||95.0||||The p-values reported are unadjusted for multiple comparisons. Dunnet's procedure for multiple dose comparisons to placebo was used for primary efficacy measure at Week 3.|Mixed Models Analysis|||N=135/arm (405 total) for 85% power for 2-sample t-test (2-sided alpha=0.05) based on true mean difference=3.5 and SD=10. Interim Analysis (IA) to validate sample-size assumptions and adjust sample-size if needed. Based on IA results total sample-size increased to N=223/arm (669 total) to maintain desired power. Null Hypothesis=No statistically significant difference between add-on ziprasidone (higher, lower dose) and add-on placebo groups with respect to the population mean for primary endpoint||||0.1077
72398545|NCT00312494|144303611|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4274||95.0||||The p-values reported are unadjusted for multiple comparisons. Dunnet's procedure for multiple dose comparisons to placebo was used for primary efficacy measure at Week 3.|Mixed Models Analysis|||Week 3 Mixed Model Repeated Measures (MMRM) with model terms: treatment, length of prior lithium/divalproex usage, type of mood stabilizer therapy, rapid cycling, hospitalization status, visit, treatment by visit interaction, and baseline YMRS total score. Tests were 2-sided and performed at the 0.05 significance level.||||0.4274
72398546|NCT00312494|144303612|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4025||95.0||||The p-values reported are unadjusted for multiple comparisons.|Mixed Models Analysis|||Week 1 MMRM with model terms: treatment, length of prior lithium/divalproex usage, type of mood stabilizer therapy, rapid cycling, hospitalization status, visit, treatment by visit interaction, and baseline YMRS total score.||||0.4025
72398547|NCT00312494|144303612|SUPERIORITY_OR_OTHER_LEGACY|||||||0.283||95.0||||The p-values reported are unadjusted for multiple comparisons.|Mixed Models Analysis|||Week 1 MMRM with model terms: treatment, length of prior lithium/divalproex usage, type of mood stabilizer therapy, rapid cycling, hospitalization status, visit, treatment by visit interaction, and baseline YMRS total score.||||0.2830
72398548|NCT00312494|144303612|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4125||95.0||||The p-values reported are unadjusted for multiple comparisons.|Mixed Models Analysis|||Week 2 MMRM with model terms: treatment, length of prior lithium/divalproex usage, type of mood stabilizer therapy, rapid cycling, hospitalization status, visit, treatment by visit interaction, and baseline YMRS total score.||||0.4125
72507378|NCT02433210|144546546|SUPERIORITY||||||=|0.23|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.230
72507379|NCT02433210|144546546|SUPERIORITY||||||=|0.678|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.678
72507380|NCT02433210|144546546|SUPERIORITY||||||=|0.643|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.643
72507381|NCT02433210|144546546|SUPERIORITY||||||=|0.43|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.430
72623107|NCT00488293|144776669|SUPERIORITY_OR_OTHER|||||||0.61|TWO_SIDED||||||t-test, 2 sided|||||||0.61
72398549|NCT00312494|144303612|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1527||95.0||||The p-values reported are unadjusted for multiple comparisons.|Mixed Models Analysis|||Week 2 MMRM with model terms: treatment, length of prior lithium/divalproex usage, type of mood stabilizer therapy, rapid cycling, hospitalization status, visit, treatment by visit interaction, and baseline YMRS total score.||||0.1527
72398550|NCT00312494|144303613|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0101||95.0||||The p-values reported are unadjusted for multiple comparisons.|Mixed Models Analysis|||Week 1 MMRM with model terms: treatment, length of prior lithium/divalproex usage, type of mood stabilizer therapy, rapid cycling, hospitalization status, visit, treatment by visit interaction, and baseline MADRS total score.||||0.0101
72398551|NCT00312494|144303613|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0694||95.0||||The p-values reported are unadjusted for multiple comparisons.|Mixed Models Analysis|||Week 1 MMRM with model terms: treatment, length of prior lithium/divalproex usage, type of mood stabilizer therapy, rapid cycling, hospitalization status, visit, treatment by visit interaction, and baseline MADRS total score.||||0.0694
72398552|NCT00312494|144303613|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0183||95.0||||The p-values reported are unadjusted for multiple comparisons|Mixed Models Analysis|||Week 2 MMRM with model terms: treatment, length of prior lithium/divalproex usage, type of mood stabilizer therapy, rapid cycling, hospitalization status, visit, treatment by visit interaction, and baseline MADRS total score.||||0.0183
72398553|NCT00312494|144303613|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0176||95.0||||The p-values reported are unadjusted for multiple comparisons|Mixed Models Analysis|||Week 2 MMRM with model terms: treatment, length of prior lithium/divalproex usage, type of mood stabilizer therapy, rapid cycling, hospitalization status, visit, treatment by visit interaction, and baseline MADRS total score.||||0.0176
72398554|NCT00312494|144303613|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2302||95.0||||The p-values reported are unadjusted for multiple comparisons|Mixed Models Analysis|||Week 3 MMRM with model terms: treatment, length of prior lithium/divalproex usage, type of mood stabilizer therapy, rapid cycling, hospitalization status, visit, treatment by visit interaction, and baseline MADRS total score.||||0.2302
72475102|NCT00688870|144475403|SUPERIORITY_OR_OTHER_LEGACY||ratio of GMCs|0.91|||||TWO_SIDED|95.0|0.7|1.17|||||Confidence intervals for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC-7vPnC reference).|Common serotypes - serotype 6B||1.17|0.70|
72475103|NCT00688870|144475403|SUPERIORITY_OR_OTHER_LEGACY||ratio of GMCs|0.67|||||TWO_SIDED|95.0|0.55|0.82|||||Confidence intervals for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC-7vPnC reference).|Common serotypes - serotype 9V||0.82|0.55|
72507382|NCT02433210|144546546|SUPERIORITY||||||=|0.295|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.295
72398555|NCT00312494|144303613|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0796||95.0||||The p-values reported are unadjusted for multiple comparisons.|Mixed Models Analysis|||Week 3 MMRM with model terms: treatment, length of prior lithium/divalproex usage, type of mood stabilizer therapy, rapid cycling, hospitalization status, visit, treatment by visit interaction, and baseline MADRS total score.||||0.0796
72475104|NCT00688870|144475403|SUPERIORITY_OR_OTHER_LEGACY||ratio of GMCs|0.84|||||TWO_SIDED|95.0|0.67|1.06|||||Confidence intervals for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC-7vPnC reference).|Common serotypes - serotype 14||1.06|0.67|
72507383|NCT02433210|144546546|SUPERIORITY||||||=|0.723|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.723
72398556|NCT00312494|144303614|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6191||95.0||||The p-values reported are unadjusted for multiple comparisons.|Mixed Models Analysis|||Week 1 MMRM with model terms: treatment, length of prior lithium/divalproex usage, type of mood stabilizer therapy, rapid cycling, hospitalization status, visit, treatment by visit interaction, and baseline as covariate.||||0.6191
72398557|NCT00312494|144303614|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5629||95.0||||The p-values reported are unadjusted for multiple comparisons.|Mixed Models Analysis|||Week 1 MMRM with model terms: treatment, length of prior lithium/divalproex usage, type of mood stabilizer therapy, rapid cycling, hospitalization status, visit, treatment by visit interaction, and baseline as covariate.||||0.5629
72398558|NCT00312494|144303614|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9049||95.0||||The p-values reported are unadjusted for multiple comparisons.|Mixed Models Analysis|||Week 2 MMRM with model terms: treatment, length of prior lithium/divalproex usage, type of mood stabilizer therapy, rapid cycling, hospitalization status, visit, treatment by visit interaction, and baseline as covariate.||||0.9049
72398559|NCT00312494|144303614|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7153||95.0||||The p-values reported are unadjusted for multiple comparisons.|Mixed Models Analysis|||Week 2 MMRM with model terms: treatment, length of prior lithium/divalproex usage, type of mood stabilizer therapy, rapid cycling, hospitalization status, visit, treatment by visit interaction, and baseline as covariate.||||0.7153
72398560|NCT00312494|144303614|SUPERIORITY_OR_OTHER_LEGACY|||||||0.242||95.0||||The p-values reported are unadjusted for multiple comparisons.|Mixed Models Analysis|||Week 3 MMRM with model terms: treatment, length of prior lithium/divalproex usage, type of mood stabilizer therapy, rapid cycling, hospitalization status, visit, treatment by visit interaction, and baseline as covariate.||||0.2420
72475105|NCT00688870|144475403|SUPERIORITY_OR_OTHER_LEGACY||ratio of GMCs|0.78|||||TWO_SIDED|95.0|0.63|0.97|||||Confidence intervals for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC-7vPnC reference).|Common serotypes - serotype 18C||0.97|0.63|
72507384|NCT02433210|144546546|SUPERIORITY||||||=|0.749|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.749
72507385|NCT02433210|144546546|SUPERIORITY||||||=|0.967|||||||Wilcoxon (Mann-Whitney)|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.967
72507386|NCT02433210|144546547|SUPERIORITY||||||=|0.67|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.670
72566100|NCT04146363|144662937|SUPERIORITY||Risk Difference (RD)|35.1|||<|1e-06|TWO_SIDED|95.0|26.3|43.9|||Cochran-Mantel-Haenszel|||||43.9|26.3|<0.000001
72475106|NCT00688870|144475403|SUPERIORITY_OR_OTHER_LEGACY||ratio of GMCs|0.75|||||TWO_SIDED|95.0|0.6|0.94|||||Confidence intervals for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC-7vPnC reference).|Common serotypes - serotype 19F||0.94|0.60|
72475107|NCT00688870|144475403|SUPERIORITY_OR_OTHER_LEGACY||ratio of GMCs|0.59|||||TWO_SIDED|95.0|0.46|0.77|||||Confidence intervals for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC-7vPnC reference).|Common serotypes - serotype 23F||0.77|0.46|
72507387|NCT02433210|144546547|SUPERIORITY||||||=|0.993|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.993
72623108|NCT00488293|144776670|SUPERIORITY_OR_OTHER|||||||0.36|TWO_SIDED||||||t-test, 2 sided|||||||0.36
72623109|NCT00488293|144776671|SUPERIORITY_OR_OTHER|||||||0.73|TWO_SIDED||||||t-test, 2 sided|||||||0.73
72623110|NCT00488293|144776672|SUPERIORITY_OR_OTHER|||||||0.22|TWO_SIDED||||||t-test, 2 sided|||||||0.22
72623111|NCT00488293|144776673|SUPERIORITY_OR_OTHER|||||||0.65|TWO_SIDED||||||Chi-squared|||||||0.65
72623112|NCT03345550|144776679|SUPERIORITY|||||||0.24|||||||Kruskal-Wallis|||Baseline||||.24
72623113|NCT03345550|144776679|SUPERIORITY|||||||0.43|||||||Kruskal-Wallis|||1 month analysis||||.43
72623114|NCT03345550|144776679|SUPERIORITY|||||||0.54|||||||Kruskal-Wallis|||3 month||||.54
72623115|NCT03345550|144776682|SUPERIORITY|||||||0.31|||||||Chi-squared|||||||.31
72623116|NCT00666263|144776713|SUPERIORITY_OR_OTHER_LEGACY||Difference in least squared means|35.13||||0.005|TWO_SIDED|95.0|8.81|61.46|||ANOVA|Fixed effects ANOVA with factors for sequence (1 or 2), nested within sequence, period (Cross-Over Period 1 or 2), \& treatment (IGIV, 10% or placebo)||||61.46|8.81|0.005
72623117|NCT00666263|144776714|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|ONE_SIDED|95.0|||||McNemar|||||||<0.001
72623118|NCT00666263|144776716|SUPERIORITY_OR_OTHER_LEGACY||Difference in least squared means|32.54|||<|0.001|TWO_SIDED|95.0|14.01|51.06|||ANOVA|||||51.06|14.01|<0.001
72623119|NCT00666263|144776717|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|ONE_SIDED|95.0|||||McNemar|||||||<0.001
72623120|NCT00666263|144776721|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squared Means|6.03||||0.002|TWO_SIDED|95.0|2.14|9.92|||ANOVA|||||9.92|2.14|0.002
72623121|NCT00666263|144776723|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squared Means|-15.57|||<|0.001|TWO_SIDED|95.0|-24.37|-6.77|||ANOVA|||||-6.77|-24.37|<0.001
72623122|NCT00666263|144776725|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squared Means|-26.11|||<|0.001|TWO_SIDED|95.0|-38.96|-13.26|||ANOVA|||||-13.26|-38.96|<0.001
72623123|NCT00666263|144776727|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squared Means|-216.6||||0.059|TWO_SIDED|95.0|-490.41|57.22|||ANOVA|||||57.22|-490.41|0.059
72623124|NCT00666263|144776729|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|ONE_SIDED|95.0|||||McNemar|||||||<0.001
72623125|NCT00666263|144776730|SUPERIORITY_OR_OTHER_LEGACY|||||||0.021||95.0|||||McNemar|||||||0.021
72623126|NCT00586157|144776740|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Z-test|||||||<.001
72623127|NCT00586157|144776741|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||Z-test|||||||.001
72623128|NCT00586157|144776742|SUPERIORITY_OR_OTHER|||||||0.003||95.0|||||Z-test|||||||.003
72623129|NCT00062764|144776747|SUPERIORITY_OR_OTHER|||||||0.004||95.0|||||paired t-test|||||||0.004
72623130|NCT02378480|144776774|NON_INFERIORITY|A non-inferiority margin of 10% was used for the analysis.|treatment difference|-0.7|||||TWO_SIDED|95.0|-6.3|4.9|||||The 95% confidence interval was constructed based on the Miettinen and Nurminen method without stratification. Treatment difference for a response of clinical success was calculated as omadacycline minus linezolid.|||4.9|-6.3|
72623131|NCT02378480|144776775|NON_INFERIORITY|A non-inferiority margin of 10% was used for the analysis.|treatment difference|2.5|||||TWO_SIDED|95.0|-3.2|8.2|||||The 95% confidence interval was constructed based on the Miettinen and Nurminen method without stratification. Treatment difference for a response of clinical success was calculated as omadacycline minus linezolid.|||8.2|-3.2|
72623132|NCT02378480|144776776|NON_INFERIORITY|A non-inferiority margin of 10% was used for the analysis.|treatment difference|2.8|||||TWO_SIDED|95.0|-1.0|6.9|||||The 95% confidence interval was constructed based on the Miettinen and Nurminen method without stratification. Treatment difference for a response of clinical success was calculated as omadacycline minus linezolid.|||6.9|-1.0|
72623133|NCT01217892|144776794|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.22|STANDARD_ERROR_OF_MEAN|0.084||0.0106|TWO_SIDED|95.0|-0.38|-0.05||significant at alpha=0.05 (2-sided) applying Hochberg's method across the two Dapagliflozin BID groups.|ANCOVA|with treatment group as effect (all treatment groups included) and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0 (with alpha = 0.05 using Hochberg's method to control the overall Type I error across hypotheses in the two Dapagliflozin BID groups, two-sided)||-0.05|-0.38|0.0106
72623134|NCT01217892|144776794|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.35|STANDARD_ERROR_OF_MEAN|0.0843|<|0.0001|TWO_SIDED|95.0|-0.52|-0.18||significant at alpha=0.05 (2-sided) applying Hochberg's method across the two Dapagliflozin BID groups.|ANCOVA|with treatment group as effect (all treatment groups included) and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0 (with alpha = 0.05 using Hochberg's method to control the overall Type I error across hypotheses in the two Dapagliflozin BID groups, two-sided)||-0.18|-0.52|<0.0001
72623135|NCT01217892|144776795|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.82|STANDARD_ERROR_OF_MEAN|0.363|<|0.0001|TWO_SIDED|95.0|-2.53|-1.1||significant at alpha=0.05 (2-sided). Key secondary endpoints are tested following a hierarchical closed testing procedure within treatment group for treatment groups tested significantly different from placebo for the primary endpoint.|ANCOVA|with treatment group (all treatment groups included) and stratum (HbA1c \<7.0% vs \>=7.0% at randomization) as effect and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0 (with alpha = 0.05, two-sided)||-1.10|-2.53|<0.0001
72398561|NCT00312494|144303614|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6121||95.0||||The p-values reported are unadjusted for multiple comparisons.|Mixed Models Analysis|||Week 3 MMRM with model terms: treatment, length of prior lithium/divalproex usage, type of mood stabilizer therapy, rapid cycling, hospitalization status, visit, treatment by visit interaction, and baseline as covariate.||||0.6121
72398562|NCT00312494|144303615|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6138||95.0||||The p-values reported are unadjusted for multiple comparisons.|Mixed Models Analysis|||Week 1 MMRM with model terms: treatment, length of prior lithium/divalproex usage, type of mood stabilizer therapy, rapid cycling, hospitalization status, visit, and treatment by visit interaction.||||0.6138
72398563|NCT00312494|144303615|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6536||95.0||||The p-values reported are unadjusted for multiple comparisons.|Mixed Models Analysis|||Week 1 MMRM with model terms: treatment, length of prior lithium/divalproex usage, type of mood stabilizer therapy, rapid cycling, hospitalization status, visit, and treatment by visit interaction.||||0.6536
72398564|NCT00312494|144303615|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4758||95.0||||The p-values reported are unadjusted for multiple comparisons.|Mixed Models Analysis|||Week 2 MMRM with model terms: treatment, length of prior lithium/divalproex usage, type of mood stabilizer therapy, rapid cycling, hospitalization status, visit, and treatment by visit interaction.||||0.4758
72398565|NCT00312494|144303615|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7581||95.0||||The p-values reported are unadjusted for multiple comparisons.|Mixed Models Analysis|||Week 2 MMRM with model terms: treatment, length of prior lithium/divalproex usage, type of mood stabilizer therapy, rapid cycling, hospitalization status, visit, and treatment by visit interaction.||||0.7581
72398566|NCT00312494|144303615|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2221||95.0||||The p-values reported are unadjusted for multiple comparisons.|Mixed Models Analysis|||Week 3 MMRM with model terms: treatment, length of prior lithium/divalproex usage, type of mood stabilizer therapy, rapid cycling, hospitalization status, visit, and treatment by visit interaction.||||0.2221
72398567|NCT00312494|144303615|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5665||95.0||||The p-values reported are unadjusted for multiple comparisons.|Mixed Models Analysis|||Week 3 MMRM with model terms: treatment, length of prior lithium/divalproex usage, type of mood stabilizer therapy, rapid cycling, hospitalization status, visit, and treatment by visit interaction.||||0.5665
72398568|NCT00312494|144303616|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1063||95.0||||The p-values reported are unadjusted for multiple comparisons.|Mixed Models Analysis|||Week 3 total score MMRM with model terms: treatment, length of prior lithium/divalproex usage, type of mood stabilizer therapy, rapid cycling, hospitalization status, visit, treatment by visit interaction, and baseline PANSS total score.||||0.1063
72398569|NCT00312494|144303616|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2499||95.0||||The p-values reported are unadjusted for multiple comparisons.|Mixed Models Analysis|||Week 3 total score MMRM with model terms: treatment, length of prior lithium/divalproex usage, type of mood stabilizer therapy, rapid cycling, hospitalization status, visit, treatment by visit interaction, and baseline PANSS total score.||||0.2499
72398570|NCT00312494|144303616|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0876||95.0||||The p-values reported are unadjusted for multiple comparisons.|Mixed Models Analysis|||Week 3 positive score MMRM with model terms: treatment, length of prior lithium/divalproex usage, type of mood stabilizer therapy, rapid cycling, hospitalization status, visit, treatment by visit interaction, and baseline PANSS positive score.||||0.0876
72398571|NCT00312494|144303616|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3623||95.0||||The p-values reported are unadjusted for multiple comparisons.|Mixed Models Analysis|||Week 3 positive score MMRM with model terms: treatment, length of prior lithium/divalproex usage, type of mood stabilizer therapy, rapid cycling, hospitalization status, visit, treatment by visit interaction, and baseline PANSS positive score.||||0.3623
72398572|NCT00312494|144303616|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4686||95.0||||The p-values reported are unadjusted for multiple comparisons.|Mixed Models Analysis|||Week 3 negative score MMRM with model terms: treatment, length of prior lithium/divalproex usage, type of mood stabilizer therapy, rapid cycling, hospitalization status, visit, treatment by visit interaction, and baseline PANSS negative score.||||0.4686
72398573|NCT00312494|144303616|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2202||95.0||||The p-values reported are unadjusted for multiple comparisons.|Mixed Models Analysis|||Week 3 negative score MMRM with model terms: treatment, length of prior lithium/divalproex usage, type of mood stabilizer therapy, rapid cycling, hospitalization status, visit, treatment by visit interaction, and baseline PANSS negative score.||||0.2202
72398574|NCT00312494|144303617|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0728||95.0||||The p-values reported are unadjusted for multiple comparisons.|Mixed Models Analysis|||Week 3 MMRM with model terms: treatment, length of prior lithium/divalproex usage, type of mood stabilizer therapy, rapid cycling, hospitalization status, visit, treatment by visit interaction, and baseline GAF score.||||0.0728
72475108|NCT00688870|144475403|SUPERIORITY_OR_OTHER_LEGACY||ratio of GMCs|202.58|||||TWO_SIDED|95.0|157.04|261.32|||||Confidence intervals for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC-7vPnC reference).|Additional serotypes - serotype 1||261.32|157.04|
72475109|NCT00688870|144475403|SUPERIORITY_OR_OTHER_LEGACY||ratio of GMCs|24.11|||||TWO_SIDED|95.0|18.46|31.49|||||Confidence intervals for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC-7vPnC reference).|Additional serotypes - serotype 3||31.49|18.46|
72475110|NCT00688870|144475403|SUPERIORITY_OR_OTHER_LEGACY||ratio of GMCs|5.69|||||TWO_SIDED|95.0|4.37|7.41|||||Confidence intervals for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC-7vPnC reference).|Additional serotypes - serotype 5||7.41|4.37|
72475111|NCT00688870|144475403|SUPERIORITY_OR_OTHER_LEGACY||ratio of GMCs|5.82|||||TWO_SIDED|95.0|4.42|7.67|||||Confidence intervals for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC-7vPnC reference).|Additional serotypes - serotype 6A||7.67|4.42|
72475112|NCT00688870|144475403|SUPERIORITY_OR_OTHER_LEGACY||ratio of GMCs|96.1|||||TWO_SIDED|95.0|75.6|122.17|||||Confidence intervals for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC-7vPnC reference).|Additional serotypes - serotype 7F||122.17|75.60|
72566101|NCT04146363|144662938|SUPERIORITY||LS Mean Difference (Final Values)|-38.31|STANDARD_ERROR_OF_MEAN|4.151|<|1e-06|TWO_SIDED|95.0|-46.4|-30.2|||ANCOVA|||||-30.2|-46.4|<0.000001
72475113|NCT00688870|144475403|SUPERIORITY_OR_OTHER_LEGACY||ratio of GMCs|1.5|||||TWO_SIDED|95.0|1.23|1.83|||||Confidence intervals for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC-7vPnC reference).|Additional serotypes - serotype 19A||1.83|1.23|
72398575|NCT00312494|144303617|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3174||95.0||||The p-values reported are unadjusted for multiple comparisons.|Mixed Models Analysis|||Week 3 MMRM with model terms: treatment, length of prior lithium/divalproex usage, type of mood stabilizer therapy, rapid cycling, hospitalization status, visit, treatment by visit interaction, and baseline GAF score.||||0.3174
72475114|NCT00688870|144475404|SUPERIORITY_OR_OTHER_LEGACY||ratio of GMC|0.64|||||TWO_SIDED|95.0|0.49|0.84|||||Confidence intervals for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC-7vPnC reference).|Common serotypes - serotype 4||0.84|0.49|
72475115|NCT00688870|144475404|SUPERIORITY_OR_OTHER_LEGACY||ratio of GMCs|1.03|||||TWO_SIDED|95.0|0.77|1.36|||||Confidence intervals for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC-7vPnC reference).|Common serotypes - serotype 6B||1.36|0.77|
72475116|NCT00688870|144475404|SUPERIORITY_OR_OTHER_LEGACY||ratio of GMCs|0.82|||||TWO_SIDED|95.0|0.64|1.05|||||Confidence intervals for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC-7vPnC reference).|Common serotypes - serotype 9V||1.05|0.64|
72475117|NCT00688870|144475404|SUPERIORITY_OR_OTHER_LEGACY||ratio of GMCs|0.68|||||TWO_SIDED|95.0|0.51|0.91|||||Confidence intervals for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC-7vPnC reference).|Common serotypes - serotype 14||0.91|0.51|
72507388|NCT02433210|144546547|SUPERIORITY||||||=|0.65|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.650
72507389|NCT02433210|144546547|SUPERIORITY||||||=|0.299|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.299
72507390|NCT02433210|144546547|SUPERIORITY||||||=|0.659|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.659
72507391|NCT02433210|144546547|SUPERIORITY||||||=|0.176|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.176
72507392|NCT02433210|144546547|SUPERIORITY||||||=|0.853|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.853
72623136|NCT01217892|144776795|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.18|STANDARD_ERROR_OF_MEAN|0.3636|<|0.0001|TWO_SIDED|95.0|-2.89|-1.46||significant at alpha=0.05 (2-sided). Key secondary endpoints are tested following a hierarchical closed testing procedure within treatment group for treatment groups tested significantly different from placebo for the primary endpoint.|ANCOVA|with treatment group (all treatment groups included) and stratum (HbA1c \<7.0% vs \>=7.0% at randomization) as effect and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0 (with alpha = 0.05, two-sided)||-1.46|-2.89|<0.0001
72623137|NCT01217892|144776796|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.7|STANDARD_ERROR_OF_MEAN|3.04|<|0.0001|TWO_SIDED|95.0|-21.7|-9.7||significant at alpha=0.05 (2-sided). Key secondary endpoints are tested following a hierarchical closed testing procedure within treatment group for treatment groups tested significantly different from placebo for the primary endpoint.|ANCOVA|with treatment group (all treatment groups included) and stratum (HbA1c \<7.0% vs \>=7.0% at randomization) as effect and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0 (with alpha = 0.05, two-sided)||-9.7|-21.7|<0.0001
72475118|NCT00688870|144475404|SUPERIORITY_OR_OTHER_LEGACY||ratio of GMCs|0.75|||||TWO_SIDED|95.0|0.57|0.99|||||Confidence intervals for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC-7vPnC reference).|Common serotypes - serotype 18C||0.99|0.57|
72507393|NCT02433210|144546547|SUPERIORITY||||||=|0.494|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.494
72507394|NCT02433210|144546547|SUPERIORITY||||||=|0.631|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.631
72475119|NCT00688870|144475404|SUPERIORITY_OR_OTHER_LEGACY||ratio of GMCs|1.09|||||TWO_SIDED|95.0|0.83|1.43|||||Confidence intervals for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC-7vPnC reference).|Common serotypes - serotype 19F||1.43|0.83|
72475120|NCT00688870|144475404|SUPERIORITY_OR_OTHER_LEGACY||ratio of GMCs|0.69|||||TWO_SIDED|95.0|0.52|0.92|||||Confidence intervals for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC-7vPnC reference).|Common serotypes - serotype 23F||0.92|0.52|
72507395|NCT02433210|144546547|SUPERIORITY||||||=|0.37|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.370
72507396|NCT02433210|144546547|SUPERIORITY||||||=|0.95|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.950
72507397|NCT02433210|144546547|SUPERIORITY||||||=|0.377|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.377
72507398|NCT02433210|144546548|SUPERIORITY||||||=|0.534|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.534
72507399|NCT02433210|144546548|SUPERIORITY||||||=|0.578|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.578
72507400|NCT02433210|144546548|SUPERIORITY||||||=|0.225|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.225
72475121|NCT00688870|144475404|SUPERIORITY_OR_OTHER_LEGACY||ratio of GMCs|303.73|||||TWO_SIDED|95.0|213.63|431.83|||||Confidence intervals for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC-7vPnC reference).|Additional serotypes - serotype 1||431.83|213.63|
72475122|NCT00688870|144475404|SUPERIORITY_OR_OTHER_LEGACY||ratio of GMCs|10.65|||||TWO_SIDED|95.0|7.77|14.62|||||Confidence intervals for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC-7vPnC reference).|Additional serotypes - serotype 3||14.62|7.77|
72475123|NCT00688870|144475404|SUPERIORITY_OR_OTHER_LEGACY||ratio of GMCs|4.79|||||TWO_SIDED|95.0|3.78|6.08|||||Confidence intervals for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC-7vPnC reference).|Additional serotypes - serotype 5||6.08|3.78|
72475124|NCT00688870|144475404|SUPERIORITY_OR_OTHER_LEGACY||ratio of GMCs|3.05|||||TWO_SIDED|95.0|2.28|4.08|||||Confidence intervals for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC-7vPnC reference).|Additional serotypes - serotype 6A||4.08|2.28|
72475125|NCT00688870|144475404|SUPERIORITY_OR_OTHER_LEGACY||ratio of GMCs|105.0|||||TWO_SIDED|95.0|75.6|145.84|||||Confidence intervals for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC-7vPnC reference).|Additional serotypes - serotype 7F||145.84|75.60|
72475126|NCT00688870|144475404|SUPERIORITY_OR_OTHER_LEGACY||ratio of GMCs|4.45|||||TWO_SIDED|95.0|3.54|5.6|||||Confidence intervals for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC-7vPnC reference).|Additional serotypes - serotype 19A||5.60|3.54|
72475127|NCT00688870|144475405|SUPERIORITY_OR_OTHER_LEGACY|||||||0.735||95.0|||||Fisher Exact|||For Tenderness - Any, Fisher exact test was used to calculate p-value.||||0.735
72475128|NCT00688870|144475405|SUPERIORITY_OR_OTHER_LEGACY|||||||0.533||95.0|||||Fisher Exact|||For Tenderness - Significant, Fisher exact test was used to calculate p-value.||||0.533
72507401|NCT02433210|144546548|SUPERIORITY||||||=|0.125|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.125
72507402|NCT02433210|144546548|SUPERIORITY||||||=|0.466|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.466
72475129|NCT00688870|144475405|SUPERIORITY_OR_OTHER_LEGACY|||||||0.039||95.0|||||Fisher Exact|||For Swelling - Any, Fisher exact test was used to calculate p-value.||||0.039
72475130|NCT00688870|144475405|SUPERIORITY_OR_OTHER_LEGACY|||||||0.059||95.0|||||Fisher Exact|||For Swelling - Mild, Fisher exact test was used to calculate p-value.||||0.059
72507403|NCT02433210|144546548|SUPERIORITY||||||=|0.534|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.534
72475131|NCT00688870|144475405|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.99||95.0|||||Fisher Exact|||For Swelling - Moderate, Fisher exact test was used to calculate p-value.||||>0.99
72507404|NCT02433210|144546548|SUPERIORITY||||||=|0.584|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.584
72398576|NCT00312494|144303618|SUPERIORITY_OR_OTHER_LEGACY|||||||0.446||95.0||||The p-values reported are unadjusted for multiple comparisons.|Mixed Models Analysis|||Week 3 MMRM with model terms: treatment, length of prior lithium/divalproex usage, type of mood stabilizer therapy, rapid cycling, hospitalization status, visit, treatment by visit interaction, and baseline LIFE-RIFT total score.||||0.4460
72475132|NCT00688870|144475405|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.99||95.0|||||Fisher Exact|||For Redness - Any, Fisher exact test was used to calculate p-value.||||>0.99
72475133|NCT00688870|144475405|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.99||95.0|||||Fisher Exact|||For Redness - Mild, Fisher exact test was used to calculate p-value.||||>0.99
72475134|NCT00688870|144475405|SUPERIORITY_OR_OTHER_LEGACY|||||||0.275||95.0|||||Fisher Exact|||For Redness - Moderate, Fisher exact test was used to calculate p-value.||||0.275
72475135|NCT00688870|144475406|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.99||95.0|||||Fisher Exact|||For Tenderness - Any, Fisher exact test was used to calculate p-value.||||>0.99
72475136|NCT00688870|144475406|SUPERIORITY_OR_OTHER_LEGACY|||||||0.617||95.0|||||Fisher Exact|||For Tenderness - Significant, Fisher exact test was used to calculate p-value.||||0.617
72507405|NCT02433210|144546548|SUPERIORITY||||||=|0.981|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.981
72507406|NCT02433210|144546548|SUPERIORITY||||||=|0.568|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.568
72507407|NCT02433210|144546548|SUPERIORITY||||||=|0.24|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.240
72507408|NCT02433210|144546548|SUPERIORITY||||||=|0.724|||||||Wilcoxon (Mann-Whitney)|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.724
72507409|NCT02433210|144546548|SUPERIORITY||||||=|0.445|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.445
72507410|NCT02433210|144546549|SUPERIORITY||||||=|0.114|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.114
72507411|NCT02433210|144546549|SUPERIORITY||||||=|0.292|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.292
72507412|NCT02433210|144546549|SUPERIORITY||||||=|0.714|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.714
72566102|NCT04146363|144662939|SUPERIORITY||LS Mean Difference (Final Values)|-18.5|STANDARD_ERROR_OF_MEAN|2.0|<|1e-06|TWO_SIDED|95.0|-22.4|-14.5|||Mixed Models Analysis|||||-14.5|-22.4|<0.000001
72566103|NCT04146363|144662940|SUPERIORITY||Risk Difference (RD)|10.7||||0.000412|TWO_SIDED|95.0|6.2|15.2|||Cochran-Mantel-Haenszel|||||15.2|6.2|0.000412
72566104|NCT04146363|144662941|SUPERIORITY||LS Mean Difference (Final Values)|-5.8|STANDARD_ERROR_OF_MEAN|0.68|<|1e-06|TWO_SIDED|95.0|-7.1|-4.5|||ANCOVA|||||-4.5|-7.1|<0.000001
72623138|NCT01217892|144776796|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.7|STANDARD_ERROR_OF_MEAN|3.039|<|0.0001|TWO_SIDED|95.0|-22.7|-10.7||significant at alpha=0.05 (2-sided). Key secondary endpoints are tested following a hierarchical closed testing procedure within treatment group for treatment groups tested significantly different from placebo for the primary endpoint.|ANCOVA|with treatment group (all treatment groups included) and stratum (HbA1c \<7.0% vs \>=7.0% at randomization) as effect and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0 (with alpha = 0.05, two-sided)||-10.7|-22.7|<0.0001
72475137|NCT00688870|144475406|SUPERIORITY_OR_OTHER_LEGACY|||||||0.81||95.0|||||Fisher Exact|||For Swelling - Any, Fisher exact test was used to calculate p-value.||||0.810
72475138|NCT00688870|144475406|SUPERIORITY_OR_OTHER_LEGACY|||||||0.81||95.0|||||Fisher Exact|||For Swelling - Mild, Fisher exact test was used to calculate p-value.||||0.810
72475139|NCT00688870|144475406|SUPERIORITY_OR_OTHER_LEGACY|||||||0.674||95.0|||||Fisher Exact|||For Redness - Any, Fisher exact test was used to calculate p-value.||||0.674
72475140|NCT00688870|144475406|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.99||95.0|||||Fisher Exact|||For Redness - Mild, Fisher exact test was used to calculate p-value.||||>0.99
72475141|NCT00688870|144475406|SUPERIORITY_OR_OTHER_LEGACY|||||||0.497||95.0|||||Fisher Exact|||For Redness - Moderate, Fisher exact test was used to calculate p-value.||||0.497
72475142|NCT00688870|144475407|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.99||95.0|||||Fisher Exact|||For Tenderness - Any, Fisher exact test was used to calculate p-value.||||>0.99
72475143|NCT00688870|144475407|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.99||95.0|||||Fisher Exact|||For Tenderness - Significant, Fisher exact test was used to calculate p-value.||||>0.99
72475144|NCT00688870|144475407|SUPERIORITY_OR_OTHER_LEGACY|||||||0.044||95.0|||||Fisher Exact|||For Swelling - Any, Fisher exact test was used to calculate p-value.||||0.044
72475145|NCT00688870|144475407|SUPERIORITY_OR_OTHER_LEGACY|||||||0.076||95.0|||||Fisher Exact|||For Swelling - Mild, Fisher exact test was used to calculate p-value.||||0.076
72475146|NCT00688870|144475407|SUPERIORITY_OR_OTHER_LEGACY|||||||0.496||95.0|||||Fisher Exact|||For Swelling - Moderate, Fisher exact test was used to calculate p-value.||||0.496
72475147|NCT00688870|144475407|SUPERIORITY_OR_OTHER_LEGACY|||||||0.361||95.0|||||Fisher Exact|||For Redness - Any, Fisher exact test was used to calculate p-value.||||0.361
72475148|NCT00688870|144475407|SUPERIORITY_OR_OTHER_LEGACY|||||||0.635||95.0|||||Fisher Exact|||For Redness - Mild, Fisher exact test was used to calculate p-value.||||0.635
72475149|NCT00688870|144475407|SUPERIORITY_OR_OTHER_LEGACY|||||||0.244||95.0|||||Fisher Exact|||For Redness - Moderate, Fisher exact test was used to calculate p-value.||||0.244
72475150|NCT00688870|144475408|SUPERIORITY_OR_OTHER_LEGACY|||||||0.076||95.0|||||Fisher Exact|||For Tenderness - Any, Fisher exact test was used to calculate p-value.||||0.076
72475151|NCT00688870|144475408|SUPERIORITY_OR_OTHER_LEGACY|||||||0.735||95.0|||||Fisher Exact|||For Swelling - Any, Fisher exact test was used to calculate p-value.||||0.735
72475152|NCT00688870|144475408|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.99||95.0|||||Fisher Exact|||For Swelling - Mild, Fisher exact test was used to calculate p-value.||||>0.99
72475153|NCT00688870|144475408|SUPERIORITY_OR_OTHER_LEGACY|||||||0.477||95.0|||||Fisher Exact|||For Swelling - Moderate, Fisher exact test was used to calculate p-value.||||0.477
72475154|NCT00688870|144475408|SUPERIORITY_OR_OTHER_LEGACY|||||||0.805||95.0|||||Fisher Exact|||For Redness - Any, Fisher exact test was used to calculate p-value.||||0.805
72475155|NCT00688870|144475408|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.99||95.0|||||Fisher Exact|||For Redness - Mild, Fisher exact test was used to calculate p-value.||||>0.99
72475156|NCT00688870|144475408|SUPERIORITY_OR_OTHER_LEGACY|||||||0.477||95.0|||||Fisher Exact|||For Redness - Moderate, Fisher exact test was used to calculate p-value.||||0.477
72475157|NCT00688870|144475409|SUPERIORITY_OR_OTHER_LEGACY|||||||0.633||95.0|||||Fisher Exact|||For Fever \>=38 but \<=39 degrees C, Fisher exact test was used to calculate p-value.||||0.633
72507413|NCT02433210|144546549|SUPERIORITY||||||=|0.176|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.176
72507414|NCT02433210|144546549|SUPERIORITY||||||=|0.19|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.190
72507415|NCT02433210|144546549|SUPERIORITY|||||||-0.009|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||-0.009
72507416|NCT02433210|144546549|SUPERIORITY||||||=|0.911|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.911
72507417|NCT02433210|144546549|SUPERIORITY||||||=|0.388|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.388
72566105|NCT04146363|144662942|SUPERIORITY||Risk Difference (RD)|38.8|||<|1e-06|TWO_SIDED|95.0|28.3|49.3|||Cochran-Mantel-Haenszel|||||49.3|28.3|<0.000001
72566106|NCT04146363|144662943|SUPERIORITY||Risk Difference (RD)|41.8|||<|1e-06|TWO_SIDED|95.0|31.2|52.3|||Cochran-Mantel-Haenszel|||||52.3|31.2|<0.000001
72566107|NCT04146363|144662944|SUPERIORITY||LS Mean Difference (Final Values)|-32.35|STANDARD_ERROR_OF_MEAN|5.23|<|1e-06|TWO_SIDED|95.0|-42.6|-22.1|||ANCOVA|||||-22.1|-42.6|<0.000001
72566108|NCT04146363|144662945|SUPERIORITY||LS Mean Difference (Final Values)|-0.75|STANDARD_ERROR_OF_MEAN|0.098|<|1e-06|TWO_SIDED|95.0|-0.9|-0.6|||ANCOVA|||||-0.6|-0.9|<0.000001
72475158|NCT00688870|144475409|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.99||95.0|||||Fisher Exact|||For Fever \>39 but \<=40 degrees C, Fisher exact test was used to calculate p-value.||||>0.99
72475159|NCT00688870|144475409|SUPERIORITY_OR_OTHER_LEGACY|||||||0.527||95.0|||||Fisher Exact|||For Decreased appetite, Fisher exact test was used to calculate p-value.||||0.527
72475160|NCT00688870|144475409|SUPERIORITY_OR_OTHER_LEGACY|||||||0.613||95.0|||||Fisher Exact|||For Irritability, Fisher exact test was used to calculate p-value.||||0.613
72475161|NCT00688870|144475409|SUPERIORITY_OR_OTHER_LEGACY|||||||0.753||95.0|||||Fisher Exact|||For Increased sleep, Fisher exact test was used to calculate p-value.||||0.753
72475162|NCT00688870|144475409|SUPERIORITY_OR_OTHER_LEGACY|||||||0.748||95.0|||||Fisher Exact|||For Decreased sleep, Fisher exact test was used to calculate p-value.||||0.748
72475163|NCT00688870|144475410|SUPERIORITY_OR_OTHER_LEGACY|||||||0.327||95.0|||||Fisher Exact|||For Fever \>=38 but \<=39 degrees C, Fisher exact test was used to calculate p-value.||||0.327
72475164|NCT00688870|144475410|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.99||95.0|||||Fisher Exact|||For Fever \>39 but \<=40 degrees C, Fisher exact test was used to calculate p-value.||||>0.99
72475165|NCT00688870|144475410|SUPERIORITY_OR_OTHER_LEGACY|||||||0.522||95.0|||||Fisher Exact|||For Decreased appetite, Fisher exact test was used to calculate p-value.||||0.522
72475166|NCT00688870|144475410|SUPERIORITY_OR_OTHER_LEGACY|||||||0.872||95.0|||||Fisher Exact|||For Irritability, Fisher exact test was used to calculate p-value.||||0.872
72475167|NCT00688870|144475410|SUPERIORITY_OR_OTHER_LEGACY|||||||0.868||95.0|||||Fisher Exact|||For Increased sleep, Fisher exact test was used to calculate p-value.||||0.868
72475168|NCT00688870|144475410|SUPERIORITY_OR_OTHER_LEGACY|||||||0.237||95.0|||||Fisher Exact|||For Decreased sleep, Fisher exact test was used to calculate p-value.||||0.237
72475169|NCT00688870|144475411|SUPERIORITY_OR_OTHER_LEGACY|||||||0.329||95.0|||||Fisher Exact|||For Fever \>=38 but \<=39 degrees C, Fisher exact test was used to calculate p-value.||||0.329
72475170|NCT00688870|144475411|SUPERIORITY_OR_OTHER_LEGACY|||||||0.492||95.0|||||Fisher Exact|||For Fever \>39 but \<=40 degrees C, Fisher exact test was used to calculate p-value.||||0.492
72475171|NCT00688870|144475411|SUPERIORITY_OR_OTHER_LEGACY|||||||0.496||95.0|||||Fisher Exact|||For Fever \>40 degrees C, Fisher exact test was used to calculate p-value.||||0.496
72475172|NCT00688870|144475411|SUPERIORITY_OR_OTHER_LEGACY|||||||0.322||95.0|||||Fisher Exact|||For Decreased appetite, Fisher exact test was used to calculate p-value.||||0.322
72475173|NCT00688870|144475411|SUPERIORITY_OR_OTHER_LEGACY|||||||0.61||95.0|||||Fisher Exact|||For Irritability, Fisher exact test was used to calculate p-value.||||0.610
72507418|NCT02433210|144546549|SUPERIORITY||||||=|0.337|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.337
72475174|NCT00688870|144475411|SUPERIORITY_OR_OTHER_LEGACY|||||||0.726||95.0|||||Fisher Exact|||For Increased sleep, Fisher exact test was used to calculate p-value.||||0.726
72475175|NCT00688870|144475411|SUPERIORITY_OR_OTHER_LEGACY|||||||0.855||95.0|||||Fisher Exact|||For Decreased sleep, Fisher exact test was used to calculate p-value.||||0.855
72475176|NCT00688870|144475412|SUPERIORITY_OR_OTHER_LEGACY|||||||0.326||95.0|||||Fisher Exact|||For Fever \>=38 but \<=39 degrees C, Fisher exact test was used to calculate p-value.||||0.326
72475177|NCT00688870|144475412|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.99||95.0|||||Fisher Exact|||For Fever \>39 but \<=40 degrees C, Fisher exact test was used to calculate p-value.||||>0.99
72475178|NCT00688870|144475412|SUPERIORITY_OR_OTHER_LEGACY|||||||0.714||95.0|||||Fisher Exact|||For Decreased appetite, Fisher exact test was used to calculate p-value.||||0.714
72475179|NCT00688870|144475412|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.99||95.0|||||Fisher Exact|||For Irritability, Fisher exact test was used to calculate p-value.||||>0.99
72475180|NCT00688870|144475412|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.99||95.0|||||Fisher Exact|||For Increased sleep, Fisher exact test was used to calculate p-value.||||>0.99
72475181|NCT00688870|144475412|SUPERIORITY_OR_OTHER_LEGACY|||||||0.525||95.0|||||Fisher Exact|||For Decreased sleep, Fisher exact test was used to calculate p-value.||||0.525
72475182|NCT01821352|144475427|SUPERIORITY_OR_OTHER||||||<|5e-05|TWO_SIDED||||||Fisher Exact|||||||<0.00005
72507419|NCT02433210|144546549|SUPERIORITY||||||=|0.575|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.575
72507420|NCT02433210|144546549|SUPERIORITY||||||=|0.88|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.880
72507421|NCT02433210|144546549|SUPERIORITY||||||=|0.731|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.731
72507422|NCT03046472|144546550|OTHER||||||<|0.001|||||||ANOVA|||||||<0.001
72507423|NCT03046472|144546551|OTHER||||||<|0.001|||||||ANOVA|||||||<0.001
72475183|NCT01821352|144475428|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Fisher Exact|||||||<0.0001
72475184|NCT01821352|144475429|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||t-test, 2 sided|||||||<0.0001
72475185|NCT02917603|144475430|EQUIVALENCE|Null hypothesis is that there would be no mean difference between baseline and last measure between intervention and control groups with p\<.05|Mean Difference (Net)|0.12|||<|0.009|TWO_SIDED||||||t-test, 2 sided|||The null hypothesis is that the mean differences between baseline and last measure in the PHQ- 9 score will not differ between groups. Study is powered a two-tailed test of significance, allowing the detection of a significant difference in either direction and the following assumptions: expected difference in PHQ-9 is 5 points, the documented clinically significant effect;78 (2) the variance of scores is 5.33; (3) error protection: α =.10, β = .20 and, (4) anticipated attrition of 15%||||<.009
72475186|NCT02917603|144475431|EQUIVALENCE|Null hypothesis is there will be the mean differences between baseline scores will be the same between groups. Study powered after primary outcome measure.|Mean Difference (Net)|0.46|||<|0.21|TWO_SIDED||||||t-test, 2 sided|||||||<.21
72475187|NCT02917603|144475432|EQUIVALENCE|Null hypothesis is there will be the mean differences between baseline scores will be the same between groups. Study powered after primary outcome measure.|Mean Difference (Net)|1.02|||<|0.06|TWO_SIDED||||||t-test, 2 sided|||||||<.06
72475188|NCT02917603|144475433|EQUIVALENCE|Null hypothesis is there will be the mean differences between baseline scores will be the same between groups. Study powered after primary outcome measure.|Mean Difference (Net)|0.23|||<|0.73|TWO_SIDED||||||t-test, 2 sided|||||||<.73
72507424|NCT03046472|144546552|OTHER|||||||0.01|||||||t-test, 2 sided|||||||0.01
72566109|NCT04146363|144662946|SUPERIORITY||Risk Difference (RD)|34.6|||<|1e-06|TWO_SIDED|95.0|26.2|43.0|||Cochran-Mantel-Haenszel|||||43.0|26.2|<0.000001
72566110|NCT04146363|144662947|SUPERIORITY||Risk Difference (RD)|1.5||||0.275529|TWO_SIDED|95.0|-0.8|3.9|||Cochran-Mantel-Haenszel|||||3.9|-0.8|0.275529
72566111|NCT04146363|144662948|SUPERIORITY||Risk Difference (RD)|5.3||||0.016656|TWO_SIDED|95.0|1.9|8.6|||Cochran-Mantel-Haenszel|||||8.6|1.9|0.016656
72566112|NCT04146363|144662949|SUPERIORITY||Risk Difference (RD)|19.3||||3e-06|TWO_SIDED|95.0|13.7|25.0|||Cochran-Mantel-Haenszel|||||25.0|13.7|0.000003
72566113|NCT04146363|144662950|SUPERIORITY||Risk Difference (RD)|1.8||||0.244105|TWO_SIDED|95.0|-0.8|4.3|||Cochran-Mantel-Haenszel|||||4.3|-0.8|0.244105
72566114|NCT04146363|144662951|SUPERIORITY||Risk Difference (RD)|5.8||||0.01445|TWO_SIDED|95.0|2.2|9.4|||Cochran-Mantel-Haenszel|||||9.4|2.2|0.014450
72566115|NCT04146363|144662952|SUPERIORITY||Risk Difference (RD)|20.9||||2e-06|TWO_SIDED|95.0|14.9|26.9|||Cochran-Mantel-Haenszel|||||26.9|14.9|0.000002
72566116|NCT04146363|144662953|SUPERIORITY||LS Mean Difference (Final Values)|-30.29|STANDARD_ERROR_OF_MEAN|3.203|<|1e-06|TWO_SIDED|95.0|-36.59|-24.0|||ANCOVA|||||-24.00|-36.59|<0.000001
72566117|NCT04146363|144662955|SUPERIORITY||Risk Difference (RD)|17.9||||0.072375|TWO_SIDED|95.0|-2.3|38.1|||Cochran-Mantel-Haenszel|||||38.1|-2.3|0.072375
72566118|NCT04146363|144662955|SUPERIORITY||Risk Difference (RD)|17.5||||0.106653|TWO_SIDED|95.0|-4.5|39.5|||Cochran-Mantel-Haenszel|||||39.5|-4.5|0.106653
72566119|NCT04146363|144662956|SUPERIORITY||Risk Difference (RD)|28.0||||0.029857|TWO_SIDED|95.0|2.8|53.2|||Cochran-Mantel-Haenszel|||||53.2|2.8|0.029857
72566120|NCT04146363|144662956|SUPERIORITY||Risk Difference (RD)|29.0||||0.019744|TWO_SIDED|95.0|4.6|53.3|||Cochran-Mantel-Haenszel|||||53.3|4.6|0.019744
72566121|NCT04146363|144662957|SUPERIORITY||Risk Difference (RD)|15.8||||0.268265|TWO_SIDED|95.0|-12.2|43.8|||Cochran-Mantel-Haenszel|||||43.8|-12.2|0.268265
72566122|NCT04146363|144662957|SUPERIORITY||Risk Difference (RD)|16.6||||0.192776|TWO_SIDED|95.0|-9.4|42.7|||Cochran-Mantel-Haenszel|||||42.7|-9.4|0.192776
72566123|NCT04146363|144662958|SUPERIORITY||Risk Difference (RD)|18.6||||0.185361|TWO_SIDED|95.0|-9.3|46.6|||Cochran-Mantel-Haenszel|||||46.6|-9.3|0.185361
72566124|NCT04146363|144662958|SUPERIORITY||Risk Difference (RD)|16.6||||0.192776|TWO_SIDED|95.0|-9.4|42.7|||Cochran-Mantel-Haenszel|||||42.7|-9.4|0.192776
72566125|NCT04146363|144662959|SUPERIORITY||LS Mean Difference (Final Values)|-1.75|STANDARD_ERROR_OF_MEAN|4.756||0.714208|TWO_SIDED|95.0|-11.15|7.66|||ANCOVA|||||7.66|-11.15|0.714208
72566126|NCT04146363|144662959|SUPERIORITY||LS Mean Difference (Final Values)|-5.63|STANDARD_ERROR_OF_MEAN|4.4748||0.237855|TWO_SIDED|95.0|-15.01|3.76|||ANCOVA|||||3.76|-15.01|0.237855
72566127|NCT04146363|144662960|SUPERIORITY||LS Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.02|<|1e-06|TWO_SIDED|95.0|0.1|0.2|||ANCOVA|||UK||0.2|0.1|<0.000001
72566128|NCT04146363|144662960|SUPERIORITY||LS Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.01|<|1e-06|TWO_SIDED|95.0|0.1|0.1|||ANCOVA|||US||0.1|0.1|<0.000001
72566129|NCT04146363|144662961|SUPERIORITY||LS Mean Difference (Final Values)|8.3|STANDARD_ERROR_OF_MEAN|1.66|<|1e-06|TWO_SIDED|95.0|5.0|11.5|||ANCOVA|||||11.5|5.0|<0.000001
72566130|NCT04146363|144662962|SUPERIORITY||LS Mean Difference (Final Values)|-7.3|STANDARD_ERROR_OF_MEAN|0.8|<|1e-06|TWO_SIDED|95.0|-8.9|-5.7|||Mixed Models Analysis|||||-5.7|-8.9|<0.000001
72566131|NCT04146363|144662963|SUPERIORITY||LS Mean Difference (Final Values)|-1.07|STANDARD_ERROR_OF_MEAN|2.917||0.716224|TWO_SIDED|95.0|-6.93|4.8|||ANCOVA|||||4.80|-6.93|0.716224
72566132|NCT04146363|144662964|SUPERIORITY||LS Mean Difference (Final Values)|-4.51|STANDARD_ERROR_OF_MEAN|2.599||0.089275|TWO_SIDED|95.0|-9.73|0.72|||ANCOVA|||||0.72|-9.73|0.089275
72566133|NCT04146363|144662965|SUPERIORITY||LS Mean Difference (Final Values)|-3.31|STANDARD_ERROR_OF_MEAN|0.796||4e-05|TWO_SIDED|95.0|-4.88|-1.75|||ANCOVA|||||-1.75|-4.88|0.000040
72566134|NCT04146363|144662966|SUPERIORITY||LS Mean Difference (Final Values)|-2.7|STANDARD_ERROR_OF_MEAN|0.697||0.000127|TWO_SIDED|95.0|-4.07|-1.33|||ANCOVA|||||-1.33|-4.07|0.000127
72566135|NCT04146363|144662967|SUPERIORITY||LS Mean Difference (Final Values)|-0.09|STANDARD_ERROR_OF_MEAN|0.121||0.455291|TWO_SIDED|95.0|-0.33|0.15|||ANCOVA|||||0.15|-0.33|0.455291
72566136|NCT04146363|144662968|SUPERIORITY||LS Mean Difference (Final Values)|-7.0|STANDARD_ERROR_OF_MEAN|1.52||6.9e-05|TWO_SIDED|95.0|-10.1|-3.9|||Mixed Models Analysis|||||-3.9|-10.1|0.000069
72566137|NCT02914236|144662969|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|Hypothesis was that the mean improvement in NOSE score exceeded 15 points||||||<0.0001
72566138|NCT02914236|144662970|SUPERIORITY||||||<|0.0001|||||||binomial test|Success threshold required at least 55% of subjects to be responders||||||<0.0001
72566139|NCT00836719|144662975|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.0|||<|0.01||95.0|3.4|16.2|||Mixed Models Analysis|Anisotropic power spatial covariance matrix with terms for time and the registered voxel. Kenward Rogers approx. for degrees of freedom.|Dependent variable: NAA. Main effect: visit. Covariates Cre, %GM, %WM, %CSF and %lesion in the voxel.|N-Acetylaspartate acid (NAA) levels were measured at baseline and exit (6 months). Voxels with less than 30% error in NAA and Creatine (Cre) were used.NAA, Cre and Proton Density were log transformed.||16.2|3.4|<0.01
72566140|NCT02678442|144662980|SUPERIORITY|||||||0.01|||||||t-test, 2 sided|||||||0.01
72566141|NCT02678442|144662982|SUPERIORITY|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||||||0.001
72566142|NCT02678442|144662983|SUPERIORITY|||||||0.02|||||||t-test, 2 sided|||||||0.02
72566143|NCT02678442|144662984|SUPERIORITY|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||||||.001
72566144|NCT01045993|144662996|SUPERIORITY_OR_OTHER|||||||0.046|TWO_SIDED|||||Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05.|Proportional hazards regression model|P-value calculated using proportional hazards model with treatment term only in the model.||||||0.046
72566145|NCT01045993|144662997|NON_INFERIORITY_OR_EQUIVALENCE|The statistical alternative hypothesis tested is that the survival curves of time to first perceptible relief confirmed by meaningful relief are not identical between two treatment groups, or equivalently, the hazard ratio between two treatment groups is not equal to 1.||||||0.046|TWO_SIDED|||||Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05.|Proportional hazards regression model|P-value calculated using proportional hazards model with treatment term only in the model.||||||0.046
72398577|NCT00312494|144303618|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3253||95.0||||The p-values reported are unadjusted for multiple comparisons.|Mixed Models Analysis|||Week 3 MMRM with model terms: treatment, length of prior lithium/divalproex usage, type of mood stabilizer therapy, rapid cycling, hospitalization status, visit, treatment by visit interaction, and baseline LIFE-RIFT total score.||||0.3253
72398578|NCT00605813|144303659|SUPERIORITY_OR_OTHER_LEGACY|||||||0.003|TWO_SIDED|||||not adjusted, p=0.050|Chi-squared|||"The risk factor tested was renal dysfunction. The null hypothesis is there is no difference between with and without renal dysfunction in the participants of responders."||||0.003
72566146|NCT01045993|144662998|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05.|ANOVA|P-value calculated using analysis of variance (ANOVA) model with treatment term only in the model.||||||<0.001
72566147|NCT01045993|144662999|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED|||||Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05.|ANOVA|P-value calculated using ANOVA model with treatment term only in the model.||||||0.002
72398579|NCT00605813|144303660|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||not adjusted, p=0.050|Chi-squared|||"The risk factor tested was past medical history of other illness. The null hypothesis is there is no difference between with and without past medical history of other illness in the participants of responders."||||<0.001
72398580|NCT00605813|144303661|SUPERIORITY_OR_OTHER_LEGACY|||||||0.04|TWO_SIDED|||||not adjusted, p=0.050|Chi-squared|||"The risk factor tested was non-pharmaceutical therapies. The null hypothesis is there is no difference between with or without non-pharmaceutical therapies in the participants of responders."||||0.040
72566148|NCT01045993|144663001|SUPERIORITY_OR_OTHER|||||||0.012||95.0||||Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05.|ANOVA|P-value from ANOVA model with treatment term only in the model.||60 minutes timepoint||||0.012
72398581|NCT00605813|144303662|SUPERIORITY_OR_OTHER_LEGACY|||||||0.004|TWO_SIDED|||||not adjusted, p=0.050|Chi-squared|||"The risk factor tested was present or past history of intentional suicidal ideation. The null hypothesis is there is no difference between present or past history of intentional suicidal ideation (including suicide attempt) in the participants of responders."||||0.004
72398582|NCT02132767|144303669|SUPERIORITY_OR_OTHER|||||||0.76|||||||Wilcoxon (Mann-Whitney)|||||||0.76
72398583|NCT02132767|144303670|SUPERIORITY_OR_OTHER|||||||0.003|||||||Log Rank|||||||0.003
72398584|NCT02132767|144303671|SUPERIORITY_OR_OTHER|||||||0.14|||||||Chi-squared|||||||0.14
72398585|NCT02132767|144303672|SUPERIORITY_OR_OTHER|||||||0.71|||||||Chi-squared|||||||0.71
72398586|NCT02132767|144303673|SUPERIORITY_OR_OTHER|||||||0.03|||||||Chi-squared|||||||0.03
72398587|NCT02132767|144303674|SUPERIORITY_OR_OTHER|||||||0.88|||||||Wilcoxon (Mann-Whitney)|||||||0.88
72398588|NCT02132767|144303675|SUPERIORITY_OR_OTHER|||||||0.82|||||||Wilcoxon (Mann-Whitney)|||||||0.82
72398589|NCT02132767|144303676|SUPERIORITY_OR_OTHER|||||||0.73|||||||Regression, Poisson|||||||0.73
72398590|NCT01304966|144303691|SUPERIORITY_OR_OTHER|||||||0.013||95.0|||||t-test, 1 sided|||||||0.013
72398591|NCT00003901|144303695|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.59||||0.007|TWO_SIDED|95.0|1.13|2.23|||Regression, Cox|||||2.23|1.13|0.007
72398592|NCT00003901|144303696|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.03||||0.886|TWO_SIDED|95.0|0.69|1.54|||Regression, Cox|||||1.54|0.69|0.886
72398593|NCT00003901|144303697|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.63||||0.009|TWO_SIDED|95.0|1.13|2.36|||Regression, Cox|||||2.36|1.13|0.009
72398594|NCT00003901|144303698|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.78||||0.332|TWO_SIDED|95.0|0.48|1.28|||Regression, Cox|||||1.28|0.48|0.332
72398595|NCT00680745|144303701|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.44|STANDARD_ERROR_OF_MEAN|0.0867|<|0.0001|TWO_SIDED|95.0|-0.61|-0.27||significant at alpha=0.019 (2-sided) applying Dunnett's adjustment. A hierarchical closed testing procedure was used to control the Type I error rate across the primary and key secondary endpoints.|ANCOVA|with treatment group as effect (all treatment groups included) and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0 (with alpha = 0.019 applying Dunnett's adjustment, two-sided)||-0.27|-0.61|<0.0001
72475189|NCT01253018|144475434|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05|TWO_SIDED||||||t-test, 2 sided|||"Sample size and power calculations were performed based on the difference in the FM score between the two groups with an assumed within group SD of 15.9, the correlation of 0.5 among repeated measures. 30 subjects enrolled in each arm of the study would give 80% power for detecting a difference of 8 points on the FM.~Two sample t-tests were conducted to compare changes in FM between the two interventions groups at final training (12 week)."||||<0.05
72475190|NCT01253018|144475434|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05|TWO_SIDED||||||t-test, 2 sided|||Two sample t-tests were conducted to compare changes in FM between the two interventions groups at retention (24 weeks).||||<0.05
72475191|NCT01253018|144475436|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05|TWO_SIDED||||||t-test, 2 sided|||Two sample t-tests were conducted to compare changes in WMFT between the two interventions groups at final training 12 week.||||<0.05
72475192|NCT01253018|144475436|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05|TWO_SIDED||||||t-test, 2 sided|||Two sample t-tests were conducted to compare changes in WMFT between the two interventions groups at retention 24 weeks.||||<0.05
72475193|NCT01253018|144475437|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05|TWO_SIDED||||||t-test, 2 sided|||Two sample t-tests were conducted to compare changes in SIS Hand between the two interventions groups at final training week 12.||||<0.05
72475194|NCT01253018|144475437|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05|TWO_SIDED||||||t-test, 2 sided|||Two sample t-tests were conducted to compare changes in SIS Hand between the two interventions groups at retention week 24.||||<0.05
72398596|NCT00680745|144303701|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.49|STANDARD_ERROR_OF_MEAN|0.0885|<|0.0001|TWO_SIDED|95.0|-0.67|-0.32||significant at alpha=0.019 (2-sided) applying Dunnett's adjustment. A hierarchical closed testing procedure was used to control the Type I error rate across the primary and key secondary endpoints.|ANCOVA|with treatment group as effect (all treatment groups included) and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0 (with alpha = 0.019 applying Dunnett's adjustment, two-sided).||-0.32|-0.67|<0.0001
72398597|NCT00680745|144303701|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.68|STANDARD_ERROR_OF_MEAN|0.0873|<|0.0001|TWO_SIDED|95.0|-0.86|-0.51||significant at alpha=0.019 (2-sided) applying Dunnett's adjustment. A hierarchical closed testing procedure was used to control the Type I error rate across the primary and key secondary endpoints.|ANCOVA|with treatment group as effect (all treatment groups included) and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0 (with alpha = 0.019 applying Dunnett's adjustment, two-sided).||-0.51|-0.86|<0.0001
72398598|NCT00680745|144303702|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.46|STANDARD_ERROR_OF_MEAN|0.3153||0.141|TWO_SIDED|95.0|-1.08|0.15||not significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure within treatment group.|ANCOVA|with treatment group as effect (all treatment groups included) and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0||0.15|-1.08|0.1410
72398599|NCT00680745|144303702|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.84|STANDARD_ERROR_OF_MEAN|0.3217||0.0091|TWO_SIDED|95.0|-1.47|-0.21||significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure within treatment group.|ANCOVA|with treatment group as effect (all treatment groups included) and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0||-0.21|-1.47|0.0091
72398600|NCT00680745|144303702|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.54|STANDARD_ERROR_OF_MEAN|0.3168|<|0.0001|TWO_SIDED|95.0|-2.17|-0.92||significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure within treatment group.|ANCOVA|with treatment group as effect (all treatment groups included) and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0||-0.92|-2.17|<0.0001
72475195|NCT05260021|144475489|SUPERIORITY||LS Mean difference (Final Values)|-1.8|||<|0.001|TWO_SIDED|95.0|-2.35|-1.25|||ANCOVA|||||-1.25|-2.35|<0.001
72475196|NCT05260021|144475490|SUPERIORITY||LS Mean difference (Final Values)|-1.67|||<|0.001|TWO_SIDED|95.0|-2.31|-1.02|||ANCOVA|||||-1.02|-2.31|<0.001
72475197|NCT05260021|144475490|SUPERIORITY||LS Mean difference (Final Values)|-1.93|||<|0.001|TWO_SIDED|95.0|-2.57|-1.29|||ANCOVA|||||-1.29|-2.57|<0.001
72566149|NCT01045993|144663001|SUPERIORITY_OR_OTHER|||||||0.016||95.0||||Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05.|ANOVA|P-value from ANOVA model with treatment term only in the model.||120 minutes timepoint||||0.016
72398601|NCT00680745|144303703|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-31.5|STANDARD_ERROR_OF_MEAN|6.874|||TWO_SIDED|95.0|-45.0|-18.0||Not significant. Hierarchical closed testing procedure within treatment group stopped at previous endpoint.|ANCOVA|with treatment group as effect (all treatment groups included) and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0||-18.0|-45.0|
72398602|NCT00680745|144303703|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-26.0|STANDARD_ERROR_OF_MEAN|6.968||0.0002|TWO_SIDED|95.0|-39.7|-12.3||significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure within treatment group.|ANCOVA|with treatment group as effect (all treatment groups included) and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0||-12.3|-39.7|0.0002
72398603|NCT00680745|144303703|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-28.9|STANDARD_ERROR_OF_MEAN|6.77|<|0.0001|TWO_SIDED|95.0|-42.2|-15.6||significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure within treatment group.|ANCOVA|with treatment group as effect (all treatment groups included) and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0||-15.6|-42.2|<0.0001
72475198|NCT05260021|144475491|SUPERIORITY||Risk Difference (RD)|40.1|||<|0.001|TWO_SIDED|95.0|18.6|61.7|||Regression, Logistic|||||61.7|18.6|<0.001
72475199|NCT05260021|144475491|SUPERIORITY||Risk Difference (RD)|51.6|||<|0.001|TWO_SIDED|95.0|31.1|72.2|||Regression, Logistic|||||72.2|31.1|<0.001
72475200|NCT05260021|144475491|SUPERIORITY||Risk Difference (RD)|45.8|||<|0.001|TWO_SIDED|95.0|27.5|64.1|||Regression, Logistic|||||64.1|27.5|<0.001
72475201|NCT05260021|144475492|SUPERIORITY||LS Mean difference (Final Values)|-0.36|||<|0.001|TWO_SIDED|95.0|-0.55|-0.16|||ANCOVA|||||-0.16|-0.55|< 0.001
72475202|NCT05260021|144475492|SUPERIORITY||LS Mean difference (Final Values)|-0.66|||<|0.001|TWO_SIDED|95.0|-0.86|-0.47|||ANCOVA|||||-0.47|-0.86|<0.001
72475203|NCT05260021|144475492|SUPERIORITY||LS Mean difference (Final Values)|-0.51|||<|0.001|TWO_SIDED|95.0|-0.68|-0.34|||ANCOVA|||||-0.34|-0.68|< 0.001
72475204|NCT05260021|144475493|SUPERIORITY||LS Mean difference (Final Values)|-28.9||||0.007|TWO_SIDED|95.0|-49.7|-8.0|||ANCOVA|||||-8.0|-49.7|0.007
72475205|NCT05260021|144475493|SUPERIORITY||LS Mean difference (Final Values)|-44.0|||<|0.001|TWO_SIDED|95.0|-64.3|-23.6|||ANCOVA|||||-23.6|-64.3|< 0.001
72475206|NCT05260021|144475493|SUPERIORITY||LS Mean difference (Final Values)|-36.4|||<|0.001|TWO_SIDED|95.0|-54.2|-18.6|||ANCOVA|||||-18.6|-54.2|< 0.001
72475207|NCT05260021|144475494|SUPERIORITY||LS Mean difference (Final Values)|-6.18|||<|0.001|TWO_SIDED|95.0|-9.31|-3.05|||ANCOVA|||||-3.05|-9.31|< 0.001
72475208|NCT05260021|144475494|SUPERIORITY||LS Mean difference (Final Values)|-10.52|||<|0.001|TWO_SIDED|95.0|-13.67|-7.38|||ANCOVA|||||-7.38|-13.67|< 0.001
72566150|NCT01045993|144663001|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05.|ANOVA|P-value from ANOVA model with treatment term only in the model.||180 minutes timepoint||||<0.001
72398604|NCT00680745|144303704|SUPERIORITY_OR_OTHER||Risk Difference (RD)|13.7|STANDARD_ERROR_OF_MEAN|4.265|||TWO_SIDED|95.0|5.4|22.1||Not significant. Hierarchical closed testing procedure within treatment group stopped at previous endpoint.|Regression, Logistic|Based on methodology of Zhang, Tsiatis \& Davidian and Davidian, Tsiatis, Zhang \& Lu, with adjustment for baseline value.||H0: proportion(treat) minus proportion(placebo) = 0 versus the alternative HA: proportion(treat) minus proportion(placebo) =/= 0||22.1|5.4|
72398605|NCT00680745|144303704|SUPERIORITY_OR_OTHER||Risk Difference (RD)|17.3|STANDARD_ERROR_OF_MEAN|4.392||0.0001|TWO_SIDED|95.0|8.7|25.9||significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure within treatment group.|Regression, Logistic|Based on methodology of Zhang, Tsiatis \& Davidian and Davidian, Tsiatis, Zhang \& Lu, with adjustment for baseline value.||H0: proportion(treat) minus proportion(placebo) = 0 versus the alternative HA: proportion(treat) minus proportion(placebo) =/= 0||25.9|8.7|0.0001
72398606|NCT00680745|144303704|SUPERIORITY_OR_OTHER||Risk Difference (RD)|18.7|STANDARD_ERROR_OF_MEAN|4.457|<|0.0001|TWO_SIDED|95.0|9.9|27.4||significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure within treatment group.|Regression, Logistic|Based on methodology of Zhang, Tsiatis \& Davidian and Davidian, Tsiatis, Zhang \& Lu, with adjustment for baseline value.||H0: proportion(treat) minus proportion(placebo) = 0 versus the alternative HA: proportion(treat) minus proportion(placebo) =/= 0||27.4|9.9|<0.0001
72475209|NCT05260021|144475494|SUPERIORITY||LS Mean difference (Final Values)|-8.35|||<|0.001|TWO_SIDED|95.0|-11.05|-5.66|||ANCOVA|||||-5.66|-11.05|< 0.001
72475210|NCT05260021|144475495|SUPERIORITY||Risk Difference (RD)|29.5||||0.006|TWO_SIDED|95.0|8.6|50.3|||Regression, Logistic|||||50.3|8.6|0.006
72475211|NCT05260021|144475495|SUPERIORITY||Risk Difference (RD)|39.5|||<|0.001|TWO_SIDED|95.0|18.8|60.2|||Regression, Logistic|||||60.2|18.8|< 0.001
72475212|NCT05260021|144475495|SUPERIORITY||Risk Difference (RD)|34.6|||<|0.001|TWO_SIDED|95.0|17.0|52.1|||Regression, Logistic|||||52.1|17|< 0.001
72475213|NCT05260021|144475496|SUPERIORITY||Risk Difference (RD)|43.4|||<|0.001|TWO_SIDED|95.0|22.3|64.4|||Regression, Logistic|||||64.4|22.3|< 0.001
72507425|NCT01958671|144546559|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.99|||<|0.001|TWO_SIDED|95.0|-1.22|-0.76|||Constrained longitudinal data analysis|Fixed effects for treatment, time, prior anti-hyperglycemic medication, baseline eGFR and the interaction of time by treatment.||||-0.76|-1.22|<0.001
72398607|NCT00680745|144303705|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.37|STANDARD_ERROR_OF_MEAN|0.4159|||TWO_SIDED|95.0|-1.19|0.45||Not significant. Hierarchical closed testing procedure within treatment group stopped at previous endpoint.|ANCOVA|with treatment group as effect (all treatment groups included) and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0||0.45|-1.19|
72398608|NCT00680745|144303705|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.94|STANDARD_ERROR_OF_MEAN|0.4234||0.0262|TWO_SIDED|95.0|-1.78|-0.11||significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure within treatment group.|ANCOVA|with treatment group as effect (all treatment groups included) and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0||-0.11|-1.78|0.0262
72475214|NCT05260021|144475496|SUPERIORITY||Risk Difference (RD)|47.1|||<|0.001|TWO_SIDED|95.0|26.4|67.7|||Regression, Logistic|||||67.7|26.4|< 0.001
72475215|NCT05260021|144475496|SUPERIORITY||Risk Difference (RD)|45.2|||<|0.001|TWO_SIDED|95.0|26.3|64.1|||Regression, Logistic|||||64.1|26.3|< 0.001
72475216|NCT05260021|144475498|SUPERIORITY||LS Mean difference (Final Values)|0.014||||0.708|TWO_SIDED|95.0|-0.061|0.089|||Mixed Models Analysis|||||0.089|-0.061|0.708
72475217|NCT05260021|144475498|SUPERIORITY||LS Mean difference (Final Values)|-0.001||||0.976|TWO_SIDED|95.0|-0.076|0.074|||Mixed Models Analysis|||||0.074|-0.076|0.976
72475218|NCT05260021|144475498|SUPERIORITY||LS Mean difference (Final Values)|0.007||||0.841|TWO_SIDED|95.0|-0.058|0.071|||Mixed Models Analysis|||||0.071|-0.058|0.841
72475219|NCT05260021|144475499|SUPERIORITY||LS Mean difference (Final Values)|-0.29|||<|0.001|TWO_SIDED|95.0|-0.45|-0.12|||Mixed Models Analysis|||||-0.12|-0.45|< 0.001
72475220|NCT05260021|144475499|SUPERIORITY||LS Mean difference (Final Values)|-0.4|||<|0.001|TWO_SIDED|95.0|-0.57|-0.24|||Mixed Models Analysis|||||-0.24|-0.57|< 0.001
72475221|NCT05260021|144475499|SUPERIORITY||LS Mean difference (Final Values)|-0.34|||<|0.001|TWO_SIDED|95.0|-0.49|-0.2|||Mixed Models Analysis|||||-0.2|-0.49|< 0.001
72475222|NCT03843554|144475511|SUPERIORITY|Primary hypothesis. Null hypothesis is that the proportion of patients with a successful outcome of WHO OM severity grades 0-2 at the post study evaluation will not differ between the two randomized intervention groups. The estimated proportion of successes from our pilot trial is 0.30 with SOC. The alternative hypothesis is that the proportion of patients with a successful outcome differs between the two groups from the SOC proportion of 0.30 by +/-0.265 or more.||||||0.999|||||||Fisher Exact|OM WHO grading scale (less or equal to 2) severity employed a two-sided Fisher's exact test to compare the two arms at Visit 9.||||||0.999
72507426|NCT01958671|144546559|SUPERIORITY_OR_OTHER||Difference in least squares means|-1.16|||<|0.001|TWO_SIDED|95.0|-1.39|-0.93|||Constrained longitudinal data analysis|Fixed effects for treatment, time, prior anti-hyperglycemic medication, baseline eGFR and the interaction of time by treatment.||||-0.93|-1.39|<0.001
72507427|NCT01958671|144546560|SUPERIORITY_OR_OTHER||Difference in percentage|-2.6|||||TWO_SIDED|95.0|-13.1|8.1|||||Based on Miettinen \& Nurminen method.|||8.1|-13.1|
72507428|NCT01958671|144546560|SUPERIORITY_OR_OTHER||Difference in percentage|-4.2|||||TWO_SIDED|95.0|-14.8|6.6|||||Based on Miettinen \& Nurminen method.|||6.6|-14.8|
72507429|NCT01958671|144546561|SUPERIORITY_OR_OTHER||Difference in percentage|-2.0|||||TWO_SIDED|95.0|-7.7|3.3|||||Based on Miettinen \& Nurminen method.|||3.3|-7.7|
72507430|NCT01958671|144546561|SUPERIORITY_OR_OTHER||Difference in percentage|-2.6|||||TWO_SIDED|95.0|-8.2|2.7|||||Based on Miettinen \& Nurminen method.|||2.7|-8.2|
72475223|NCT03843554|144475512|SUPERIORITY|OMDP-STANDARD|Mean Difference (Final Values)|-3.3|STANDARD_ERROR_OF_MEAN|174.6||0.6336|TWO_SIDED|95.0||||The above t-test p-value is for IL1a.|t-test, 2 sided|||The change in the inflammatory marker from baseline to the final intervention visit was analyzed using 95% confidence intervals and presented by treatment group. The two-sided t-test was used to compare the change in inflammatory markers between the two groups.||||0.6336
72475224|NCT03843554|144475512|SUPERIORITY|OMDP-STANDARD|Mean Difference (Final Values)|-17.1|STANDARD_ERROR_OF_MEAN|52.1||0.351|TWO_SIDED|95.0||||IL1b|t-test, 2 sided|||The change in the inflammatory marker from baseline to the final intervention visit was analyzed using 95% confidence intervals and presented by treatment group. The two-sided t- test was used to compare the change in inflammatory markers between the two groups.||||0.3510
72475225|NCT03843554|144475512|SUPERIORITY|OMDP-STANDARD|Mean Difference (Final Values)|-102.2|STANDARD_ERROR_OF_MEAN|252.8||0.351|TWO_SIDED|95.0||||IL2|t-test, 2 sided|||The change in the inflammatory marker from baseline to the final intervention visit was analyzed using 95% confidence intervals and presented by treatment group. The two-sided t- test was used to compare the change in inflammatory markers between the two groups.||||0.3510
72507431|NCT01958671|144546562|SUPERIORITY_OR_OTHER||Difference in least squares means|-34.53|||<|0.001|TWO_SIDED|95.0|-42.76|-26.29|||Constrained longitudinal data analysis|Fixed effects for treatment, time, prior anti-hyperglycemic medication, baseline eGFR and the interaction of time by treatment.||||-26.29|-42.76|<0.001
72507432|NCT01958671|144546562|SUPERIORITY_OR_OTHER||Difference in least squares means|-44.01|||<|0.001|TWO_SIDED|95.0|-52.28|-35.74|||Constrained longitudinal data analysis|Fixed effects for treatment, time, prior anti-hyperglycemic medication, baseline eGFR and the interaction of time by treatment.||||-35.74|-52.28|<0.001
72507433|NCT01958671|144546563|SUPERIORITY_OR_OTHER||Difference in least squares means|-1.76|||<|0.001|TWO_SIDED|95.0|-2.57|-0.95|||Constrained longitudinal data analysis|Fixed effects for treatment, time, prior anti-hyperglycemic medication, baseline eGFR and the interaction of time by treatment.||||-0.95|-2.57|<0.001
72507434|NCT01958671|144546563|SUPERIORITY_OR_OTHER||Difference in least squares means|-2.16|||<|0.001|TWO_SIDED|95.0|-2.98|-1.34|||Constrained longitudinal data analysis|Fixed effects for treatment, time, prior anti-hyperglycemic medication, baseline eGFR and the interaction of time by treatment.||||-1.34|-2.98|<0.001
72507435|NCT01958671|144546564|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.59|||<|0.001|TWO_SIDED|95.0|1.85|6.95|||Regression, Logistic|Fixed effects for treatment, prior antihyperglycemic medication, covariates for baseline A1C and baseline eGFR.||||6.95|1.85|<0.001
72475226|NCT03843554|144475512|SUPERIORITY|IL4|Mean Difference (Final Values)|-20.4|STANDARD_ERROR_OF_MEAN|46.0||0.8371|TWO_SIDED|95.0|||||t-test, 2 sided|||The change in the inflammatory marker from baseline to the final intervention visit was analyzed using 95% confidence intervals and presented by treatment group. The two-sided t- test was used to compare the change in inflammatory markers between the two groups.||||0.8371
72507436|NCT01958671|144546564|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.77|||<|0.001|TWO_SIDED|95.0|3.46|13.24|||Regression, Logistic|Fixed effects for treatment, prior antihyperglycemic medication, covariates for baseline A1C and baseline||||13.24|3.46|<0.001
72507437|NCT01958671|144546566|SUPERIORITY_OR_OTHER||Difference in least squares means|-69.03|||<|0.001|TWO_SIDED|95.0|-83.24|-54.83|||Constrained longitudinal data analysis|Fixed effects for treatment, time, prior anti-hyperglycemic medication, baseline eGFR and the interaction of time by treatment.||||-54.83|-83.24|<0.001
72507438|NCT01958671|144546566|SUPERIORITY_OR_OTHER||Difference in least squares means|-67.33|||<|0.001|TWO_SIDED|95.0|-81.73|-52.93|||Constrained longitudinal data analysis|Fixed effects for treatment, time, prior anti-hyperglycemic medication, baseline eGFR and the interaction of time by treatment.||||-52.93|-81.73|<0.001
72507439|NCT01958671|144546568|SUPERIORITY_OR_OTHER||Difference in least squares means|-3.31||||0.015|TWO_SIDED|95.0|-5.98|-0.65||Nominal p-value|Constrained longitudinal data analysis|Fixed effects for treatment, time, prior anti-hyperglycemic medication, baseline eGFR and the interaction of time by treatment.||||-0.65|-5.98|0.015
72507440|NCT01958671|144546568|SUPERIORITY_OR_OTHER||Difference in least squares means|-1.71||||0.213|TWO_SIDED|95.0|-4.4|0.98|||Constrained longitudinal data analysis|Fixed effects for treatment, time, prior anti-hyperglycemic medication, baseline eGFR and the interaction of time by treatment.||||0.98|-4.40|0.213
72507441|NCT01958671|144546570|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|-1.8||||0.039|TWO_SIDED|95.0|-3.51|-0.09||Nominal p-value|Constrained longitudinal data analysis|Fixed effects for treatment, time, prior anti-hyperglycemic medication, baseline eGFR and the interaction of time by treatment.||||-0.09|-3.51|0.039
72507442|NCT01958671|144546570|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.37||||0.669|TWO_SIDED|95.0|-2.09|1.35||Nominal p-value|Constrained longitudinal data analysis|Fixed effects for treatment, time, prior anti-hyperglycemic medication, baseline eGFR and the interaction of time by treatment.||||1.35|-2.09|0.669
72507443|NCT04760314|144546571|SUPERIORITY||Risk Difference (RD)|22.6|||<|0.001|TWO_SIDED|95.0|11.6|33.6|||Cochran-Mantel-Haenszel|||||33.6|11.6|<0.001
72507444|NCT04760314|144546571|SUPERIORITY||Risk Difference (RD)|27.3|||<|0.001|TWO_SIDED|95.0|17.5|37.0|||Cochran-Mantel-Haenszel|||||37.0|17.5|<0.001
72507445|NCT04760314|144546572|SUPERIORITY||Risk Difference (RD)|33.2|||<|0.001|TWO_SIDED|95.0|20.6|45.8|||Cochran-Mantel-Haenszel|||||45.8|20.6|<0.001
72507446|NCT04760314|144546572|SUPERIORITY||Risk Difference (RD)|37.6|||<|0.001|TWO_SIDED|95.0|26.2|49.0|||Cochran-Mantel-Haenszel|||||49.0|26.2|<0.001
72507447|NCT04760314|144546573|SUPERIORITY||LS Mean Difference|-34.5|||<|0.001|TWO_SIDED|95.0|-44.1|-24.9|||ANCOVA|||||-24.9|-44.1|<0.001
72507448|NCT04760314|144546573|SUPERIORITY||LS Mean Difference|-38.99|||<|0.001|TWO_SIDED|95.0|-47.7|-30.3|||ANCOVA|||||-30.3|-47.7|<0.001
72507449|NCT04760314|144546574|SUPERIORITY||Risk Difference (RD)|18.4||||0.003|TWO_SIDED|95.0|6.8|29.9|||Cochran-Mantel-Haenszel|||||29.9|6.8|0.003
72507450|NCT04760314|144546574|SUPERIORITY||Risk Difference (RD)|24.2|||<|0.001|TWO_SIDED|95.0|13.9|34.5|||Cochran-Mantel-Haenszel|||||34.5|13.9|<0.001
72507451|NCT04760314|144546575|SUPERIORITY||Risk Difference (RD)|1.2||||0.404|TWO_SIDED|95.0|-1.2|3.6|||Cochran-Mantel-Haenszel|||||3.6|-1.2|0.404
72475227|NCT03843554|144475512|SUPERIORITY|IL5|Mean Difference (Final Values)|-1.7|STANDARD_ERROR_OF_MEAN|10.7||0.2991|TWO_SIDED|95.0|||||t-test, 2 sided|||The change in the inflammatory marker from baseline to the final intervention visit was analyzed using 95% confidence intervals and presented by treatment group. The two-sided t- test was used to compare the change in inflammatory markers between the two groups.||||0.2991
72398609|NCT00680745|144303705|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.67|STANDARD_ERROR_OF_MEAN|0.4211|<|0.0001|TWO_SIDED|98.0|-2.5|-0.84||significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure within treatment group.|ANCOVA|with treatment group as effect (all treatment groups included) and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0||-0.84|-2.50|<0.0001
72398610|NCT00680745|144303706|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.9|STANDARD_ERROR_OF_MEAN|3.522|||TWO_SIDED|95.0|-21.8|-7.9||Not significant. Hierarchical closed testing procedure within treatment group stopped at previous endpoint.|ANCOVA|with treatment group as effect (all treatment groups included) and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0||-7.9|-21.8|
72398611|NCT00680745|144303706|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.3|STANDARD_ERROR_OF_MEAN|3.594|<|0.0001|TWO_SIDED|95.0|-26.3|-12.2||significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure within treatment group.|ANCOVA|with treatment group as effect (all treatment groups included) and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0||-12.2|-26.3|<0.0001
72398612|NCT00680745|144303706|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-26.5|STANDARD_ERROR_OF_MEAN|3.545|<|0.0001|TWO_SIDED|95.0|-33.5|-19.5||significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure within treatment group.|ANCOVA|with treatment group as effect (all treatment groups included) and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0||-19.5|-33.5|<0.0001
72398613|NCT02612428|144303707|SUPERIORITY||Hazard Ratio (HR)|0.913||||0.762|TWO_SIDED|95.0|0.509|1.64|||Log Rank|||The primary endpoint was assessed using a Kaplan-Meier survival analysis of the Intent-to-treat (ITT) population utilizing a log-rank test.||1.640|0.509|0.762
72398614|NCT02612428|144303708|SUPERIORITY|||||||0.6829|||||||Chi-squared|||||||0.6829
72398615|NCT02612428|144303709|SUPERIORITY|||||||0.048|||||||Chi-squared|||||||0.048
72475228|NCT03843554|144475513|SUPERIORITY|OMDP-STANDARD|Mean Difference (Final Values)|-0.2293|STANDARD_ERROR_OF_MEAN|0.8555||0.2373|TWO_SIDED|95.0|-1.906|1.4475|||t-test, 2 sided|||||1.4475|-1.9060|0.2373
72398616|NCT00137423|144303710|SUPERIORITY_OR_OTHER||Objective Response Rate|28.3||||||95.0|16.8|42.3|||F distribution|||Objective response rate required a sample size of 100 to test null hypothesis that true response rate was \<=5% versus alternative hypothesis that true response rate was \>=15% with 90% power and alpha level of 0.05. If number of OR\> =11 null hypothesis that true response rate was \<=5% could be rejected with a target α error rate of 0.05.||42.3|16.8|
72398617|NCT00137423|144303710|SUPERIORITY_OR_OTHER||Objective Response Rate|11.5||||||95.0|4.4|23.4|||F distribution|||Objective response rate required a sample size of 100 to test null hypothesis that true response rate was \<=5% versus alternative hypothesis that true response rate was \>=15% with 90% power and alpha level of 0.05. If number of OR\> =11 null hypothesis that true response rate was \<=5% could be rejected with a target α error rate of 0.05.||23.4|4.4|
72398618|NCT00137423|144303714|SUPERIORITY_OR_OTHER||1-year survival rate|77.4||||||95.0|63.6|86.5|||Kaplan-Meier method||valid presentation only if at least 1 patient has overall survival \>=1 year. Based on normal approximation, 95% CI will be derived by log transformation of the cumulative hazard rate.|||86.5|63.6|
72398619|NCT00137423|144303714|SUPERIORITY_OR_OTHER||1-year survival rate|66.0||||||95.0|51.6|77.1|||Kaplan-Meier method||valid presentation only if at least 1 patient has overall survival \>=1 year. Based on normal approximation, 95% CI will be derived by log transformation of the cumulative hazard rate.|||77.1|51.6|
72398620|NCT01928329|144303718|SUPERIORITY||Mean Difference (Final Values)|-0.23|STANDARD_ERROR_OF_MEAN|0.13||0.0816|TWO_SIDED|95.0|-0.5|0.03||The \<0.05 is the apriori threshold for statistical significance.|Mixed Models Analysis|HbA1c Linear Mixed Model Results (adjusts the model for: baseline BMI, gender, study site, race (White/Non White) and Baseline C-Peptide production).||||0.03|-0.50|0.0816
72398621|NCT01928329|144303719|SUPERIORITY||Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.13||0.912|TWO_SIDED|95.0|-0.28|0.25||The \<0.05 is the apriori threshold for statistical significance.|Mixed Models Analysis|HbA1c Linear Mixed Model Results (adjusts the model for: baseline BMI, gender, study site, race (White/Non White) and Baseline C-Peptide production).||||0.25|-0.28|0.912
72398622|NCT01928329|144303720|SUPERIORITY||Z score|-0.801||||0.423|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.423
72398623|NCT01928329|144303721|SUPERIORITY||Z score|-1.312||||0.189|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.189
72398624|NCT02141997|144303737|SUPERIORITY_OR_OTHER||||||=|0.863|||||||Fisher Exact|||P-value calculated using 1-sided Fisher's Exact test.||||=0.863
72398625|NCT02141997|144303737|SUPERIORITY_OR_OTHER||||||=|0.414|||||||Fisher Exact|||P-value calculated using 1-sided Fisher's Exact test.||||=0.414
72507452|NCT04760314|144546576|SUPERIORITY||Risk Difference (RD)|1.8||||0.294|TWO_SIDED|95.0|-1.6|5.1|||Cochran-Mantel-Haenszel|||||5.1|-1.6|0.294
72398626|NCT02141997|144303737|SUPERIORITY_OR_OTHER||||||=|0.196|||||||Fisher Exact|||P-value calculated using 1-sided Fisher's Exact test.||||=0.196
72398627|NCT04105998|144303745|SUPERIORITY|Exploratory analysis without power calculation||||||0.64|||||||t-test, 2 sided|||Exploratory analysis without power calculation||||0.64
72398628|NCT04105998|144303746|SUPERIORITY|Exploratory analysis without power calculation||||||0.19|||||||t-test, 2 sided|||Exploratory analysis without power calculation||||0.19
72398629|NCT04105998|144303747|SUPERIORITY|Exploratory analysis without power calculation||||||0.067|||||||t-test, 2 sided|||Exploratory analysis without power calculation||||0.067
72507453|NCT04760314|144546576|SUPERIORITY||Risk Difference (RD)|3.7||||0.138|TWO_SIDED|95.0|-0.5|7.8|||Cochran-Mantel-Haenszel|||||7.8|-0.5|0.138
72507454|NCT04760314|144546577|SUPERIORITY||Risk Difference (RD)|9.2||||0.013|TWO_SIDED|95.0|1.8|16.5|||Cochran-Mantel-Haenszel|||||16.5|1.8|0.013
72475229|NCT03843554|144475514|SUPERIORITY|OMDP-STANDARD|Mean Difference (Final Values)|0.0569|STANDARD_ERROR_OF_MEAN|0.116||0.6263|TWO_SIDED|95.0|-0.1755|0.2893||A Week 8 general linear mixed effects model (GLM) was used to compare the change in saliva flow rate from Baseline (day 0) to week 8 (day 56) between the two groups. The change was calculated by subtracting week 8 saliva flow rate from the Baseline.|ANCOVA||Estimation of the difference in least-square means for the change from Baseline to FIV in saliva flow rate.|||0.2893|-0.1755|0.6263
72507455|NCT04760314|144546577|SUPERIORITY||Risk Difference (RD)|16.2||||0.001|TWO_SIDED|95.0|8.1|24.3|||Cochran-Mantel-Haenszel|||||24.3|8.1|0.001
72507456|NCT04760314|144546578|SUPERIORITY||Risk Difference (RD)|20.6||||0.001|TWO_SIDED|95.0|8.7|32.4|||Cochran-Mantel-Haenszel|||||32.4|8.7|0.001
72566151|NCT01045993|144663001|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05.|ANOVA|P-value from ANOVA model with treatment term only in the model.||240 minutes timepoint||||0.002
72566152|NCT01045993|144663001|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05.|ANOVA|P-value from ANOVA model with treatment term only in the model.||300 minutes timepoint||||<0.001
72566153|NCT01045993|144663001|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05.|ANOVA|P-value from ANOVA model with treatment term only in the model.||360 minutes timepoint||||<0.001
72475230|NCT03843554|144475515|SUPERIORITY|OMDP-STANDARD|Mean Difference (Net)|-1.94||||0.6956|TWO_SIDED|95.0|||||Regression, Linear|A Week 8 (Day 56) GLM analyzing the pain change Week 8 relative to Baseline (Day 0) was used with treatment and Baseline pain as covariates.|Difference in least-square mean change from baseline to Visit 9 in pain score.|||||0.6956
72507457|NCT04760314|144546578|SUPERIORITY||Risk Difference (RD)|29.2|||<|0.001|TWO_SIDED|95.0|17.9|40.4|||Cochran-Mantel-Haenszel|||||40.4|17.9|<0.001
72507458|NCT01290484|144546579|SUPERIORITY_OR_OTHER||Mean percentage volume change|-3.47||||||||||||||||||
72507459|NCT01505491|144546594|EQUIVALENCE|p-value for ratio outside interval 80% to 125%|Geometric mean ratio (%)|113.22|STANDARD_ERROR_OF_MEAN|1.086||0.1163|TWO_SIDED|90.0|98.752|129.812|||ANOVA||Bio-equivalence of BI 695501 vs. Humira US was estimated by the ratios of the adjusted geometric means (gMean). Standard error of the mean is actually geometric standard error.|ANOVA (analysis of variance) model on the logarithm scale was used with 'treatment' and 'age' as fixed effect.||129.812|98.752|0.1163
72507460|NCT01505491|144546594|EQUIVALENCE|p-value for ratio outside interval 80% to 125%|Geometric mean ratio (%)|132.24|STANDARD_ERROR_OF_MEAN|1.094||0.7345|TWO_SIDED|90.0|113.984|153.412|||ANOVA||Bio-equivalence of BI 695501 vs. Humira EU was estimated by the ratios of the adjusted geometric means (gMean). Standard error of the mean is actually geometric standard error.|ANOVA (analysis of variance) model on the logarithm scale was used with 'treatment' and 'age' as fixed effect.||153.412|113.984|0.7345
72566154|NCT01045993|144663001|SUPERIORITY_OR_OTHER|||||||0.003||95.0||||Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05.|ANOVA|P-value from ANOVA model with treatment term only in the model.||420 minutes timepoint||||0.003
72398630|NCT04105998|144303748|SUPERIORITY|Exploratory analysis without power calculation||||||0.25|||||||t-test, 2 sided|||Exploratory analysis without power calculation||||0.25
72398631|NCT04105998|144303749|SUPERIORITY|Exploratory analysis without power calculation||||||0.058|||||||t-test, 2 sided|||Exploratory analysis without power calculation||||0.058
72475231|NCT03843554|144475516|SUPERIORITY|OMDP-STANDARD|Mean Difference (Final Values)|-0.188|STANDARD_ERROR_OF_MEAN|0.113||0.1153|TWO_SIDED|95.0|-0.4095|0.0334|||ANCOVA|ANCOVA via generalized linear mixed repeated measures model (GLMER)||The statistical analysis comprised an ANCOVA for a longitudinal response based on a generalized linear mixed effects repeated measures model (GLMER). The response variable is the mean change from Baseline to Visit 9 in EORTC QLQ-C30 Questions 31-48 (total).||0.0334|-0.4095|0.1153
72475232|NCT02731690|144475525|SUPERIORITY|||||||0.5303||||||Analyzed using a repeated measure GEE model, which includes the change from baseline as the dependent variable, visit as a fixed factor, and the baseline value as a covariate. Compound symmetry is used as the covariance structure.|GEE model|||Week 12||||0.5303
72475233|NCT02731690|144475525|SUPERIORITY|||||||0.1646||||||Analyzed using a repeated measure GEE model, which includes the change from baseline as the dependent variable, visit as a fixed factor, and the baseline value as a covariate. Compound symmetry is used as the covariance structure.|GEE model|||Week 24||||0.1646
72475234|NCT02731690|144475525|SUPERIORITY|||||||0.1189||||||Analyzed using a repeated measure GEE model, which includes the change from baseline as the dependent variable, visit as a fixed factor, and the baseline value as a covariate. Compound symmetry is used as the covariance structure.|GEE model|||Week 36||||0.1189
72475235|NCT02731690|144475525|SUPERIORITY|||||||0.0706||||||Analyzed using a repeated measure GEE model, which includes the change from baseline as the dependent variable, visit as a fixed factor, and the baseline value as a covariate. Compound symmetry is used as the covariance structure.|GEE model|||Week 48||||0.0706
72475236|NCT02731690|144475526|SUPERIORITY|||||||0.0715||||||Analyzed using a repeated measure GEE model, which includes the change from baseline as the dependent variable, visit as a fixed factor, and the baseline value as a covariate. Compound symmetry is used as the covariance structure.|GEE model|||Week 12||||0.0715
72507461|NCT01505491|144546594|EQUIVALENCE|p-value for ratio outside interval 80% to 125%|Geometric mean ratio (%)|86.51|STANDARD_ERROR_OF_MEAN|1.09||0.1833|TWO_SIDED|90.0|74.974|99.83|||ANOVA||Bio-equivalence of Humira EU vs. Humira US was estimated by the ratios of the adjusted geometric means (gMean). Standard error of the mean is actually geometric standard error.|ANOVA (analysis of variance) model on the logarithm scale was used with 'treatment' and 'age' as fixed effect.||99.830|74.974|0.1833
72507462|NCT01505491|144546595|EQUIVALENCE|p-value for ratio outside interval 80% to 125%|Geometric mean ratio (%)|109.42|STANDARD_ERROR_OF_MEAN|1.073||0.0303|TWO_SIDED|90.0|97.384|122.935|||ANOVA||Bio-equivalence of BI 695501 vs. Humira US was estimated by the ratios of the adjusted geometric means (gMean). Standard error of the mean is actually geometric standard error.|ANOVA (analysis of variance) model on the logarithm scale was used with 'treatment' and 'age' as fixed effect.||122.935|97.384|0.0303
72507463|NCT01505491|144546595|EQUIVALENCE|p-value for ratio outside interval 80% to 125%|Geometric mean ratio (%)|128.88|STANDARD_ERROR_OF_MEAN|1.08||0.6547|TWO_SIDED|90.0|113.492|146.365|||ANOVA||Bio-equivalence of BI 695501 vs. Humira EU was estimated by the ratios of the adjusted geometric means (gMean). Standard error of the mean is actually geometric standard error.|ANOVA (analysis of variance) model on the logarithm scale was used with 'treatment' and 'age' as fixed effect.||146.365|113.492|0.6547
72507464|NCT01505491|144546595|EQUIVALENCE|p-value for ratio outside interval 80% to 125%|Geometric mean ratio (%)|86.24|STANDARD_ERROR_OF_MEAN|1.077||0.1572|TWO_SIDED|90.0|76.238|97.564|||ANOVA||Bio-equivalence of Humira EU vs. Humira US was estimated by the ratios of the adjusted geometric means (gMean). Standard error of the mean is actually geometric standard error.|ANOVA (analysis of variance) model on the logarithm scale was used with 'treatment' and 'age' as fixed effect.||97.564|76.238|0.1572
72507465|NCT01505491|144546596|EQUIVALENCE|p-value for ratio outside interval 80% to 125%|Geometric mean ratio (%)|110.3|STANDARD_ERROR_OF_MEAN|1.063||0.0212|TWO_SIDED|90.0|99.687|122.035|||ANOVA||Bio-equivalence of BI 695501 vs. Humira US was estimated by the ratios of the adjusted geometric means (gMean). Standard error of the mean is actually geometric standard error.|ANOVA (analysis of variance) model on the logarithm scale was used with 'treatment' and 'age' as fixed effect.||122.035|99.687|0.0212
72507466|NCT01505491|144546596|EQUIVALENCE|p-value for ratio outside interval 80% to 125%|Geometric mean ratio (%)|117.53|STANDARD_ERROR_OF_MEAN|1.066||0.17|TWO_SIDED|90.0|105.638|130.757|||ANOVA||Bio-equivalence of BI 695501 vs. Humira EU was estimated by the ratios of the adjusted geometric means (gMean). Standard error of the mean is actually geometric standard error.|ANOVA (analysis of variance) model on the logarithm scale was used with 'treatment' and 'age' as fixed effect.||130.757|105.638|0.1700
72398632|NCT04105998|144303750|SUPERIORITY|Exploratory analysis without power calculation||||||0.111|||||||t-test, 2 sided|||Exploratory analysis without power calculation||||0.111
72398633|NCT00598663|144303751|SUPERIORITY||Mean Difference (Final Values)|0.43|||<|0.0001|ONE_SIDED|97.5|||||ANCOVA|ANOVA with adjustment for period effect and subject as random effect. Period was included in the model regardless of statistical significance.||||||<0.0001
72475237|NCT02731690|144475526|SUPERIORITY|||||||0.1697||||||Analyzed using a repeated measure GEE model, which includes the change from baseline as the dependent variable, visit as a fixed factor, and the baseline value as a covariate. Compound symmetry is used as the covariance structure.|GEE model|||Week 24||||0.1697
72507467|NCT01505491|144546596|EQUIVALENCE|p-value for ratio outside interval 80% to 125%|Geometric mean ratio (%)|96.53|STANDARD_ERROR_OF_MEAN|1.064||0.0016|TWO_SIDED|90.0|87.064|107.017|||ANOVA||Bio-equivalence of Humira EU vs. Humira US was estimated by the ratios of the adjusted geometric means (gMean). Standard error of the mean is actually geometric standard error.|ANOVA (analysis of variance) model on the logarithm scale was used with 'treatment' and 'age' as fixed effect.||107.017|87.064|0.0016
72507468|NCT02759146|144546599|SUPERIORITY||Difference between least squared means|0.09||||0.72|TWO_SIDED|95.0|-0.36|0.52||Adjusted for baseline and balancing factors used in the randomization|Mixed Models Analysis||Difference between reflexology and meditative practice for weeks 1-4|Aim 1: Comparing reflexology vs meditative practice for weeks 1-4||.52|-.36|.72
72475238|NCT02731690|144475526|SUPERIORITY|||||||0.3428||||||Analyzed using a repeated measure GEE model, which includes the change from baseline as the dependent variable, visit as a fixed factor, and the baseline value as a covariate. Compound symmetry is used as the covariance structure.|GEE model|||Week 36||||0.3428
72475239|NCT02731690|144475526|SUPERIORITY|||||||0.0642||||||Analyzed using a repeated measure GEE model, which includes the change from baseline as the dependent variable, visit as a fixed factor, and the baseline value as a covariate. Compound symmetry is used as the covariance structure.|GEE model|||Week 48||||0.0642
72398634|NCT01516424|144303760|NON_INFERIORITY_OR_EQUIVALENCE|The power is 80%, non-inferiority margin is 7.0.|Mean Difference (Final Values)|3.69|||<|0.05|TWO_SIDED|95.0|-0.36|7.75||Satisfaction with the non-inferiority criteria was determined by the upper limit of confidence interval. If the upper limit of 95% confidence interval was less than 7.0, then non-inferiority was concluded.|ANCOVA|Study center and grouping as fixed effects.|This is ITT analysis data.|"ANCOVA was employed to compare the changes of PANSS scores at week 8 relative to the baseline in these 2 groups. Least Squares Means for the differences in changes between the 2 groups (μ blonanserin - μ risperidone) and the two-sided 95% Confidence Interval were calculated in accordance with the main model.~H0: Compared with risperidone, blonanserin reduced more than 7.0 in mean change in PANSS total score from baseline at week 8 of treatment (μ blonanserin-μ risperidone\> 7.0)."||7.75|-0.36|<0.05
72398635|NCT01516424|144303760|NON_INFERIORITY_OR_EQUIVALENCE|The power is 80%, non-inferiority margin is 7.0.|Mean Difference (Final Values)|2.94|||<|0.05|TWO_SIDED|95.0|-0.76|6.65||Satisfaction with the non-inferiority criteria was determined by the upper limit of confidence interval. If the upper limit of 95% confidence interval was less than 7.0, then non-inferiority was concluded.|ANCOVA|Study center and grouping as fixed effects.|This is PPS analysis data.|"ANCOVA was employed to compare the changes of PANSS total scores at end of treatment relative to the baseline in these 2 groups. LSMeans for the differences in changes between the 2 groups (μ blonanserin - μ risperidone) and the two-sided 95% Confidence Interval were calculated in accordance with the main model.~H0: Compared with risperidone, blonanserin reduced more than 7.0 in mean change in PANSS total score from baseline at week 8 of treatment (μ blonanserin-μ risperidone\> 7.0)."||6.65|-0.76|<0.05
72475240|NCT02731690|144475527|SUPERIORITY|||||||0.0568||||||Analyzed using a repeated measure GEE model, which includes the change from baseline as the dependent variable, visit as a fixed factor, and the baseline value as a covariate. Compound symmetry is used as the covariance structure.|GEE model|||Week 12||||0.0568
72475241|NCT02731690|144475527|SUPERIORITY|||||||0.0533||||||Analyzed using a repeated measure GEE model, which includes the change from baseline as the dependent variable, visit as a fixed factor, and the baseline value as a covariate. Compound symmetry is used as the covariance structure.|GEE model|||Week 24||||0.0533
72475242|NCT02731690|144475527|SUPERIORITY|||||||0.0459||||||Analyzed using a repeated measure GEE model, which includes the change from baseline as the dependent variable, visit as a fixed factor, and the baseline value as a covariate. Compound symmetry is used as the covariance structure.|GEE model|||Week 36||||0.0459
72475243|NCT02731690|144475527|SUPERIORITY|||||||0.5678||||||Analyzed using a repeated measure GEE model, which includes the change from baseline as the dependent variable, visit as a fixed factor, and the baseline value as a covariate. Compound symmetry is used as the covariance structure.|GEE model|||Week 48||||0.5678
72475244|NCT02731690|144475528|SUPERIORITY|||||||0.581||||||Analyzed using a repeated measure GEE model, which includes the change from baseline as the dependent variable, visit as a fixed factor, and the baseline value as a covariate. Compound symmetry is used as the covariance structure.|GEE model|||Week 12||||0.5810
72475245|NCT02731690|144475528|SUPERIORITY|||||||0.0465||||||Analyzed using a repeated measure GEE model, which includes the change from baseline as the dependent variable, visit as a fixed factor, and the baseline value as a covariate. Compound symmetry is used as the covariance structure.|GEE model|||Week 24||||0.0465
72475246|NCT02731690|144475528|SUPERIORITY|||||||0.1047||||||Analyzed using a repeated measure GEE model, which includes the change from baseline as the dependent variable, visit as a fixed factor, and the baseline value as a covariate. Compound symmetry is used as the covariance structure.|GEE model|||Week 36||||0.1047
72475247|NCT02731690|144475528|SUPERIORITY|||||||0.0661||||||Analyzed using a repeated measure GEE model, which includes the change from baseline as the dependent variable, visit as a fixed factor, and the baseline value as a covariate. Compound symmetry is used as the covariance structure.|GEE model|||Week 48||||0.0661
72475248|NCT02731690|144475529|SUPERIORITY|||||||0.1615||||||Analyzed using a repeated measure GEE model, which includes the change from baseline as the dependent variable, visit as a fixed factor, and the baseline value as a covariate. Compound symmetry is used as the covariance structure.|GEE model|||Week 12||||0.1615
72507469|NCT02759146|144546599|SUPERIORITY||Difference between least squared means|-0.15||||0.58|TWO_SIDED|95.0|-0.72|0.41|||Mixed Models Analysis||Difference between reflexology and control for weeks 1-4|Aim 1: Comparing reflexology vs control for weeks 1-4||.41|-.72|.58
72475249|NCT02731690|144475529|SUPERIORITY|||||||0.6201||||||Analyzed using a repeated measure GEE model, which includes the change from baseline as the dependent variable, visit as a fixed factor, and the baseline value as a covariate. Compound symmetry is used as the covariance structure.|GEE model|||Week 24||||0.6201
72475250|NCT02731690|144475529|SUPERIORITY|||||||0.9229||||||Analyzed using a repeated measure GEE model, which includes the change from baseline as the dependent variable, visit as a fixed factor, and the baseline value as a covariate. Compound symmetry is used as the covariance structure.|GEE model|||Week 36||||0.9229
72475251|NCT02731690|144475529|SUPERIORITY|||||||0.6307||||||Analyzed using a repeated measure GEE model, which includes the change from baseline as the dependent variable, visit as a fixed factor, and the baseline value as a covariate. Compound symmetry is used as the covariance structure.|GEE model|||Week 48||||0.6307
72475252|NCT02731690|144475530|SUPERIORITY|||||||0.0088||||||Analyzed using a repeated measure GEE model, which includes the change from baseline as the dependent variable, visit as a fixed factor, and the baseline value as a covariate. Compound symmetry is used as the covariance structure.|GEE model|||Week 12||||0.0088
72475253|NCT02731690|144475530|SUPERIORITY|||||||0.2213||||||Analyzed using a repeated measure GEE model, which includes the change from baseline as the dependent variable, visit as a fixed factor, and the baseline value as a covariate. Compound symmetry is used as the covariance structure.|GEE model|||Week 24||||0.2213
72475254|NCT02731690|144475530|SUPERIORITY|||||||0.018||||||Analyzed using a repeated measure GEE model, which includes the change from baseline as the dependent variable, visit as a fixed factor, and the baseline value as a covariate. Compound symmetry is used as the covariance structure.|GEE model|||Week 36||||0.0180
72475255|NCT02731690|144475530|SUPERIORITY|||||||0.197||||||Analyzed using a repeated measure GEE model, which includes the change from baseline as the dependent variable, visit as a fixed factor, and the baseline value as a covariate. Compound symmetry is used as the covariance structure.|GEE model|||Week 48||||0.1970
72398636|NCT00597766|144303765|SUPERIORITY_OR_OTHER||GroupXtime interaction|-0.17||||0.16|TWO_SIDED|95.0||||Comparison 60mg vs. 20mg: F (1,92)=2.06, p=0.16|Linear mixed model|1st order antedependence covariance structure||"Hypothesis that 60mg group would have greater pain relief than the the 20mg group.~The study was powered to detect the difference in pain between the 40mg and placebo at 4-wks. To detect effect size 0.75 with alpha of 0.05, beta of 0.20, 31 the difference between the 60mg and placebo groups (effect size \> 1.0),18 participants per group are needed. \*NOTE\* the design was changed from placebo-control due to ethical concerns arising from ethical concerns of placebo injection."||||0.16
72475256|NCT02731690|144475531|SUPERIORITY|||||||0.0752||||||Analyzed using a repeated measure GEE model, which includes the change from baseline as the dependent variable, visit as a fixed factor, and the baseline value as a covariate. Compound symmetry is used as the covariance structure.|GEE model|||Week 12||||0.0752
72475257|NCT02731690|144475531|SUPERIORITY|Analyzed using a repeated measure GEE model, which includes the change from baseline as the dependent variable, visit as a fixed factor, and the baseline value as a covariate. Compound symmetry is used as the covariance structure.||||||0.6403||||||Analyzed using a repeated measure GEE model, which includes the change from baseline as the dependent variable, visit as a fixed factor, and the baseline value as a covariate. Compound symmetry is used as the covariance structure.|GEE model|||Week 24||||0.6403
72475258|NCT02731690|144475531|SUPERIORITY|Analyzed using a repeated measure GEE model, which includes the change from baseline as the dependent variable, visit as a fixed factor, and the baseline value as a covariate. Compound symmetry is used as the covariance structure.||||||0.2316||||||Analyzed using a repeated measure GEE model, which includes the change from baseline as the dependent variable, visit as a fixed factor, and the baseline value as a covariate. Compound symmetry is used as the covariance structure.|GEE model|||Week 36||||0.2316
72475259|NCT02731690|144475531|SUPERIORITY|||||||0.7635||||||Analyzed using a repeated measure GEE model, which includes the change from baseline as the dependent variable, visit as a fixed factor, and the baseline value as a covariate. Compound symmetry is used as the covariance structure.|GEE model|||Week 48||||0.7635
72475260|NCT02731690|144475532|SUPERIORITY|||||||0.0872||||||Analyzed using a repeated measure GEE model, which includes the change from baseline as the dependent variable, visit as a fixed factor, and the baseline value as a covariate. Compound symmetry is used as the covariance structure.|GEE model|||Week 12||||0.0872
72475261|NCT02731690|144475532|SUPERIORITY|||||||0.0073||||||Analyzed using a repeated measure GEE model, which includes the change from baseline as the dependent variable, visit as a fixed factor, and the baseline value as a covariate. Compound symmetry is used as the covariance structure.|GEE model|||Week 24||||0.0073
72475262|NCT02731690|144475532|SUPERIORITY|||||||0.0086||||||Analyzed using a repeated measure GEE model, which includes the change from baseline as the dependent variable, visit as a fixed factor, and the baseline value as a covariate. Compound symmetry is used as the covariance structure.|GEE model|||Week 36||||0.0086
72507470|NCT02759146|144546599|SUPERIORITY||Difference between least squared means|-0.24||||0.42|TWO_SIDED|95.0|-0.81|0.34|||Mixed Models Analysis||Difference between meditative practice and control for weeks 1-4|Aim 1: Comparing meditative practices vs control for weeks 1-4||.34|-.81|.42
72507471|NCT02759146|144546600|SUPERIORITY||Difference between least squared means|-0.01||||0.96|TWO_SIDED|95.0|-0.44|0.42|||Mixed Models Analysis||Difference between reflexology and meditative practice for weeks 1-4|Aim 1: Comparing reflexology vs meditative practice for weeks 1-4||0.42|-0.44|0.96
72475263|NCT02731690|144475532|SUPERIORITY|||||||0.0489||||||Analyzed using a repeated measure GEE model, which includes the change from baseline as the dependent variable, visit as a fixed factor, and the baseline value as a covariate. Compound symmetry is used as the covariance structure.|GEE model|||Week 48||||0.0489
72475264|NCT03446781|144475546|SUPERIORITY|||||||0.002|||||||Cochran-Mantel-Haenszel|Adjusted for analysis center||CCH 0.84 mg/Buttock versus Placebo||||0.002
72475265|NCT03446781|144475547|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|Adjusted for analysis center||CCH 0.84 mg/Buttock versus Placebo||||<0.001
72475266|NCT03446781|144475548|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|Adjusted for analysis center||CCH 0.84 mg/Buttock versus Placebo||||<0.001
72475267|NCT03446781|144475549|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|Adjusted for analysis center||CCH 0.84 mg/Buttock versus Placebo||||<0.001
72475268|NCT03446781|144475550|SUPERIORITY|||||||0.033|||||||Cochran-Mantel-Haenszel|Adjusted for analysis center||CCH 0.84 mg/Buttock versus Placebo||||0.033
72475269|NCT03446781|144475551|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|Adjusted for analysis center||CCH 0.84 mg/Buttock versus Placebo||||<0.001
72475270|NCT03446781|144475552|SUPERIORITY||||||<|0.001|||||||ANCOVA|With factors of treatment group and analysis center adjusted for baseline values in the model||CCH 0.84 mg/Buttock versus Placebo||||<0.001
72475271|NCT03446781|144475553|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|Adjusted for analysis center||CCH 0.84 mg/Buttock versus Placebo||||<0.001
72475272|NCT03446781|144475554|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|Adjusted for analysis center||CCH 0.84 mg/Buttock versus Placebo||||<0.001
72475273|NCT04410523|144475567|SUPERIORITY||Least Squares mean|0.122|STANDARD_ERROR_OF_MEAN|0.0541||0.025|TWO_SIDED|95.0|0.016|0.229|||MMRM||Treatment difference (CSJ117-placebo)|||0.229|0.016|0.025
72475274|NCT04410523|144475567|SUPERIORITY||Least Squares mean|0.058|STANDARD_ERROR_OF_MEAN|0.0542||0.286|TWO_SIDED|95.0|-0.049|0.165|||MMRM||Treatment difference (CCSJ117-placebo)|||0.165|-0.049|0.286
72475275|NCT04410523|144475567|SUPERIORITY||Least Squares mean|0.065|STANDARD_ERROR_OF_MEAN|0.0521||0.212|TWO_SIDED|95.0|-0.037|0.168|||MMRM||Treatment difference (CCSJ117-placebo)|||0.168|-0.037|0.212
72475276|NCT04410523|144475567|SUPERIORITY||Least Squares mean|0.009|STANDARD_ERROR_OF_MEAN|0.043||0.831|TWO_SIDED|95.0|-0.076|0.094|||MMRM||Treatment difference (CCSJ117-placebo)|||0.094|-0.076|0.831
72475277|NCT04410523|144475567|SUPERIORITY||Least Squares mean|-0.008|STANDARD_ERROR_OF_MEAN|0.0434||0.852|TWO_SIDED|95.0|-0.094|0.077|||MMRM||Treatment difference (CCSJ117-placebo)|||0.077|-0.094|0.852
72475278|NCT04410523|144475568|SUPERIORITY||Least Squares mean|-1.568|STANDARD_ERROR_OF_MEAN|2.363||0.508|TWO_SIDED|95.0|-6.219|3.083|||MMRM||Treatment difference (CSJ117-placebo)|||3.083|-6.219|0.508
72475279|NCT04410523|144475568|SUPERIORITY||Least Squares mean|-3.998|STANDARD_ERROR_OF_MEAN|2.384||0.095|TWO_SIDED|95.0|-8.691|0.695|||MMRM||Treatment difference (CCSJ117-placebo)|||0.695|-8.691|0.095
72475280|NCT04410523|144475568|SUPERIORITY||Least Squares mean|-2.889|STANDARD_ERROR_OF_MEAN|2.2943||0.209|TWO_SIDED|95.0|-7.405|1.627|||MMRM||Treatment difference (CCSJ117-placebo)|||1.627|-7.405|0.209
72475281|NCT04410523|144475568|SUPERIORITY||Least Squares mean|-0.287|STANDARD_ERROR_OF_MEAN|1.8718||0.878|TWO_SIDED|95.0|-3.971|3.398|||MMRM||Treatment difference (CCSJ117-placebo)|||3.398|-3.971|0.878
72507472|NCT02759146|144546600|SUPERIORITY||Difference between least squared means|-0.2||||0.48|TWO_SIDED|95.0|-0.75|0.35|||Mixed Models Analysis||Difference between reflexology and control for weeks 1-4|Aim 1: Comparing reflexology vs control for weeks 1-4||0.35|-0.75|0.48
72507473|NCT02759146|144546600|SUPERIORITY||Difference between least squared means|-0.19||||0.52|TWO_SIDED|95.0|-0.75|0.38|||Mixed Models Analysis||Difference between meditative practice and control for weeks 1-4|Aim 1: Comparing meditative practice vs control for weeks 1-4||0.38|-0.75|0.52
72507474|NCT02759146|144546601|SUPERIORITY||Difference between least squared means|0.67||||0.68|TWO_SIDED|95.0|-2.52|3.86|||Mixed Models Analysis||Comparing reflexology to meditative practices for weeks 1-4|Aim 1: Comparing reflexology vs meditative practice for weeks 1-4||3.86|-2.52|.68
72507475|NCT02759146|144546601|SUPERIORITY||Difference between least squared means|-2.53||||0.23|TWO_SIDED|95.0|-6.64|1.58|||Mixed Models Analysis||Comparing reflexology to control for weeks 1-4|Aim 1: Comparing reflexology vs control for weeks 1-4||1.58|-6.64|.23
72507476|NCT02759146|144546601|SUPERIORITY||Difference between least squared means|-3.2||||0.14|TWO_SIDED|95.0|-7.41|1.01|||Mixed Models Analysis||Comparing meditative practice to control for weeks 1-4|Aim 1: Comparing meditative practice vs control for weeks 1-4||1.01|-7.41|0.14
72566155|NCT01045993|144663001|SUPERIORITY_OR_OTHER|||||||0.001||95.0||||Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05.|ANOVA|P-value from ANOVA model with treatment term only in the model.||480 minutes timepoint||||0.001
72566156|NCT01045993|144663002|SUPERIORITY_OR_OTHER|||||||0.012||95.0||||Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05.|ANOVA|P-value from ANOVA model with treatment term only in the model.||60 minutes timepoint||||0.012
72398637|NCT00597766|144303765|SUPERIORITY_OR_OTHER||group x time interaction|-0.04||||0.77|TWO_SIDED|95.0||||Comparison 40mg vs. 20mg: F (1,90)=0.1, p=0.77|linear mixed model|first order antedependent covariance structure||"Hypothesis that 40mg group would have greater pain reduction than the 20mg group.~The study was powered to detect the difference in pain between the 40mg and placebo at 4-wks. To detect effect size 0.75 with alpha of 0.05, beta of 0.20, 31 the difference between the 60mg and placebo groups (effect size \> 1.0),18 participants per group are needed. \*NOTE\* the design was changed from placebo-control due to ethical concerns arising from ethical concerns of placebo injection."||||0.77
72398638|NCT00597766|144303766|SUPERIORITY_OR_OTHER||group x time interaction|-0.3||||0.2|TWO_SIDED|95.0||||Comparison 60mg vs. 20mg: F (1,36)=1.7, p=0.2|Linear mixed model|first order antedpendent covariance structure||This study was not powered for secondary outcomes. The effect of treatment group over time was analyzed using a linear mixed model for repeated measures with random intercept and subject effects. The dependent variable was treatment group and variables for week (continuous) and group interaction term was included in the model. The effect of treatment at discrete time points was analyzed using a linear mixed model with categorical time.||||0.2
72566157|NCT01045993|144663002|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05.|ANOVA|P-value from ANOVA model with treatment term only in the model.||120 minutes timepoint||||0.002
72566158|NCT01045993|144663002|SUPERIORITY_OR_OTHER|||||||0.033||95.0||||Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05.|ANOVA|P-value from ANOVA model with treatment term only in the model.||180 minutes timepoint||||0.033
72566159|NCT01045993|144663002|SUPERIORITY_OR_OTHER|||||||0.096||95.0||||Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05.|ANOVA|P-value from ANOVA model with treatment term only in the model.||240 minutes timepoint||||0.096
72507477|NCT02759146|144546602|SUPERIORITY||Difference between least squared means|0.01||||0.98|TWO_SIDED|95.0|-0.38|0.39|||Mixed Models Analysis||Difference between reflexology and meditative practice for weeks 1-4|Aim 1: Comparing reflexology vs meditative practice for weeks 1-4||0.39|-0.38|0.98
72507478|NCT02759146|144546602|SUPERIORITY||Difference between least squared means|-0.24||||0.34|TWO_SIDED|95.0|-0.74|0.25|||Mixed Models Analysis||Comparing reflexology to control for weeks 1-4|Aim 1: Comparing reflexology vs control for weeks 1-4||0.25|-0.74|0.34
72507479|NCT02759146|144546602|SUPERIORITY||Difference between least squared means|-0.25||||0.34|TWO_SIDED|95.0|-0.76|0.26|||Mixed Models Analysis||Comparing meditative practices vs control for weeks 1-4|Aim 1: Comparing meditative practices vs control for weeks 1-4||0.26|-0.76|0.34
72507480|NCT02759146|144546603|SUPERIORITY||Difference between least squared means|0.25||||0.57|TWO_SIDED|95.0|-0.63|1.14|||Mixed Models Analysis||After the initial 4 weeks of reflexology, comparing continued reflexology to added meditative practice|Aim 2: After 4 weeks of reflexology, comparing continuing reflexology vs adding meditative practice||1.14|-.63|0.57
72507481|NCT02759146|144546603|SUPERIORITY||Least Square (LS) Mean|0.49||||0.39|TWO_SIDED|95.0|-0.64|1.63|||Mixed Models Analysis||After the initial 4 weeks of meditative practices, comparing continuing meditative practice to adding reflexology|Aim 3: After 4 weeks of meditative practice, comparing continuing with meditative practice vs. adding reflexology for weeks 5-12||1.63|-0.64|0.39
72507482|NCT02759146|144546604|SUPERIORITY||Least Square (LS) Mean|1.94||||0.67|TWO_SIDED|95.0|-10.93|7.04|||Mixed Models Analysis||After 4 weeks of reflexology, comparing continued reflexology vs adding meditative practice|Aim 2: After 4 weeks of reflexology, comparing continued reflexology vs added meditative practice for weeks 5-12||7.04|-10.93|0.67
72507483|NCT02759146|144546604|SUPERIORITY||Least Square (LS) Mean|-1.85||||0.66|TWO_SIDED|95.0|-6.59|10.29|||Mixed Models Analysis||After 4 weeks of meditative practice, comparing continued meditative practice vs adding reflexology for weeks 5-12|Aim 3: After 4 weeks of meditative practices, comparing continued meditative practice vs adding reflexology for weeks 5-12||10.29|-6.59|0.66
72507484|NCT02759146|144546605|SUPERIORITY||Difference between least squared means|-0.19||||0.62|TWO_SIDED|95.0|-0.95|0.57|||Mixed Models Analysis||After 4 weeks of reflexology, comparing continued reflexology vs added meditative practice for weeks 5-12|Aim 2: After 4 weeks of reflexology, comparing continued reflexology vs added meditative practice for weeks 5-12||0.57|-0.95|0.62
72566160|NCT01045993|144663002|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05.|ANOVA|P-value from ANOVA model with treatment term only in the model.||300 minutes timepoint||||0.002
72475282|NCT04410523|144475568|SUPERIORITY||Least Squares mean|1.093|STANDARD_ERROR_OF_MEAN|1.8652||0.558|TWO_SIDED|95.0|-2.578|4.765|||MMRM||Treatment difference (CCSJ117-placebo)|||4.765|-2.578|0.558
72475283|NCT04410523|144475571|SUPERIORITY||Least Squares mean|-0.042|STANDARD_ERROR_OF_MEAN|0.1493||0.78|TWO_SIDED|95.0|-0.336|0.252|||MMRM||Treatment difference (CSJ117-placebo)|||0.252|-0.336|0.780
72507485|NCT02759146|144546605|SUPERIORITY||Least Square (LS) Mean|-0.04||||0.95|TWO_SIDED|95.0|-1.15|1.22|||Mixed Models Analysis||After 4 weeks of meditative practice, comparing continued meditative practice vs adding reflexology for weeks 5-12|Aim 3: After 4 weeks of meditative practice, comparing continuing meditative practice vs adding reflexology for weeks 5-12||1.22|-1.15|0.95
72507486|NCT02759146|144546606|SUPERIORITY||Difference between least squared means|-0.14||||0.77|TWO_SIDED|95.0|-1.04|0.77|||Mixed Models Analysis||After 4 weeks of reflexology, comparing continued reflexology vs added meditative practice for weeks 5-12|Aim 2: After 4 weeks of reflexology, comparing continued reflexology vs adding meditative practice for weeks 5-12||0.77|-1.04|0.77
72507487|NCT02759146|144546606|SUPERIORITY||Least Square (LS) Mean|0.22||||0.67|TWO_SIDED|95.0|-1.23|0.8|||Mixed Models Analysis||After 4 weeks of meditative practice, comparing continued meditative practice vs added reflexology for weeks 5-12|Aim 3: After 4 weeks of meditative practice, comparing continued meditative practice vs added reflexology for weeks 5-12||0.80|-1.23|0.67
72507488|NCT02759146|144546607|SUPERIORITY||Least Square (LS) Mean|0.09||||0.42|TWO_SIDED|95.0|-0.88|0.37|||Mixed Models Analysis||Comparing reflexology vs control for weeks 5-12|Aim 4: Comparing reflexology vs control for weeks 5-12||0.37|-0.88|0.42
72507489|NCT02759146|144546607|SUPERIORITY||Least Square (LS) Mean|-0.34||||0.29|TWO_SIDED|95.0|-0.98|0.29|||Mixed Models Analysis||Comparing meditative practice vs control for weeks 5-12|Aim 4: Comparing meditative practices vs control for weeks 5-12||0.29|-0.98|0.29
72507490|NCT02759146|144546608|SUPERIORITY||Least Square (LS) Mean|-0.42||||0.15|TWO_SIDED|95.0|-1.0|0.15|||Mixed Models Analysis||Comparing reflexology vs control for weeks 5-12|Aim 4: Comparing reflexology vs control for weeks 5-12||0.15|-1.00|0.15
72566161|NCT01045993|144663002|SUPERIORITY_OR_OTHER|||||||0.005||95.0||||Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05.|ANOVA|P-value from ANOVA model with treatment term only in the model.||360 minutes timepoint||||0.005
72475284|NCT04410523|144475571|SUPERIORITY||Least Squares mean|-0.42|STANDARD_ERROR_OF_MEAN|0.1489||0.005|TWO_SIDED|95.0|-0.713|-0.127|||MMRM||Treatment difference (CCSJ117-placebo)|||-0.127|-0.713|0.005
72566162|NCT01045993|144663002|SUPERIORITY_OR_OTHER|||||||0.008||95.0||||Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05.|ANOVA|P-value from ANOVA model with treatment term only in the model.||420 minutes timepoint||||0.008
72566163|NCT01045993|144663002|SUPERIORITY_OR_OTHER|||||||0.004||95.0||||Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05.|ANOVA|P-value from ANOVA model with treatment term only in the model.||480 minutes timepoint||||0.004
72475285|NCT04410523|144475571|SUPERIORITY||Least Squares mean|-0.289|STANDARD_ERROR_OF_MEAN|0.1446||0.047|TWO_SIDED|95.0|-0.573|0.004|||MMRM||Treatment difference (CCSJ117-placebo)|||0.004|-0.573|0.047
72475286|NCT04410523|144475571|SUPERIORITY||Least Squares mean|-0.017|STANDARD_ERROR_OF_MEAN|0.1182||0.887|TWO_SIDED|95.0|-0.249|0.216|||MMRM||Treatment difference (CCSJ117-placebo)|||0.216|-0.249|0.887
72507491|NCT02759146|144546608|SUPERIORITY||Least Square (LS) Mean|-0.2||||0.5|TWO_SIDED|95.0|-0.8|0.39|||Mixed Models Analysis||Comparing meditative practice vs control for weeks 5-12|Aim 4: Comparing meditative practice vs control for weeks 5-12||0.39|-0.80|0.50
72507492|NCT02759146|144546609|SUPERIORITY||Least Square (LS) Mean|-0.27||||0.33|TWO_SIDED|95.0|-0.83|0.28|||Mixed Models Analysis||Comparing reflexology vs control for week 5-12|Aim 4: Comparing reflexology vs control for weeks 5-12||0.28|-0.83|0.33
72507493|NCT02759146|144546609|SUPERIORITY||Least Square (LS) Mean|-0.36||||0.22|TWO_SIDED|95.0|-0.93|0.21|||Mixed Models Analysis|||Aim 4: Comparing meditative practice vs control for weeks 5-12||0.21|-0.93|0.22
72507494|NCT02759146|144546610|SUPERIORITY||Least Square (LS) Mean|0.92||||0.17|TWO_SIDED|95.0|-8.62|1.52|||Mixed Models Analysis||Comparing reflexology vs control for weeks 5-12|Aim 4: Comparing reflexology vs control for weeks 5-12||1.52|-8.62|0.17
72507495|NCT02759146|144546610|SUPERIORITY||Least Square (LS) Mean|-4.48||||0.09|TWO_SIDED|95.0|-9.66|0.7|||Mixed Models Analysis||Comparing meditative practice vs control for weeks 5-12|Aim 4: Comparing meditative practice vs control for weeks 5-12||0.70|-9.66|0.09
72507496|NCT00406315|144546637|SUPERIORITY_OR_OTHER_LEGACY||One-sided upper confidence limit|-0.53|||||ONE_SIDED|95.0|||||||A one-sided 95% confidence interval (CI) was constructed for the mean weight change from baseline to infer whether there was a significant decrease in weight.|Week 16.||||
72507497|NCT00406315|144546637|SUPERIORITY_OR_OTHER_LEGACY||One-sided upper confidence limit|-0.33|||||ONE_SIDED|95.0|||||||A one-sided 95% CI was constructed for the mean weight change from baseline to infer whether there was a significant decrease in weight.|Week 16 LOCF. Based on past information, the standard deviation of the mean weight difference was expected to be 2.2. The sample size of the study was estimated so that the one-sided CI of the mean weight decrease has a certain width. To obtain a one-sided CI with a width of 0.27 kg, a sample size of 180 subjects was needed. In other words, we were 95% certain that the true mean weight decrease was in an interval starting from the observed weight decrease and extending 0.27 kg unit above it.||||
72507498|NCT00406315|144546638|SUPERIORITY_OR_OTHER_LEGACY||Mean|-3.0|||||TWO_SIDED|95.0|-8.48|2.41||||||Week 16. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.||2.41|-8.48|
72507499|NCT00406315|144546639|SUPERIORITY_OR_OTHER_LEGACY||Mean|-0.2|||||TWO_SIDED|95.0|-1.82|1.44||||||HDL. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.||1.44|-1.82|
72507500|NCT00406315|144546639|SUPERIORITY_OR_OTHER_LEGACY||Mean|-2.5|||||TWO_SIDED|95.0|-7.07|2.09||||||LDL. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.||2.09|-7.07|
72566164|NCT01045993|144663003|SUPERIORITY_OR_OTHER|||||||0.268||95.0||||Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05.|ANOVA|P-value from ANOVA model with treatment term only in the model.||At Maximum degrees||||0.268
72475287|NCT04410523|144475571|SUPERIORITY||Least Squares mean|-0.115|STANDARD_ERROR_OF_MEAN|0.1184||0.333|TWO_SIDED|95.0|-0.348|0.118|||MMRM||Treatment difference (CCSJ117-placebo)|||0.118|-0.348|0.333
72475288|NCT04410523|144475572|SUPERIORITY||Least Squares mean|-0.097|STANDARD_ERROR_OF_MEAN|0.1485||0.515|TWO_SIDED|95.0|-0.389|0.195|||MMRM||Treatment difference (CSJ117-placebo)|||0.195|-0.389|0.515
72475289|NCT04410523|144475572|SUPERIORITY||Least Squares mean|0.218|STANDARD_ERROR_OF_MEAN|0.1484||0.143|TWO_SIDED|95.0|-0.074|0.51|||MMRM||Treatment difference (CCSJ117-placebo)|||0.510|-0.074|0.143
72475290|NCT04410523|144475572|SUPERIORITY||Least Squares mean|0.078|STANDARD_ERROR_OF_MEAN|0.145||0.59|TWO_SIDED|95.0|-0.207|0.364|||MMRM||Treatment difference (CCSJ117-placebo)|||0.364|-0.207|0.590
72507501|NCT00406315|144546639|SUPERIORITY_OR_OTHER_LEGACY||Mean|-1.6|||||TWO_SIDED|95.0|-16.44|13.15||||||Triglycerides. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.||13.15|-16.44|
72507502|NCT00406315|144546640|SUPERIORITY_OR_OTHER_LEGACY||Mean|0.1|||||TWO_SIDED|95.0|-0.02|0.14||||||The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.||0.14|-0.02|
72507503|NCT00406315|144546641|SUPERIORITY_OR_OTHER_LEGACY||Mean|3.0|||||TWO_SIDED|95.0|-0.09|6.15||||||The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.||6.15|-0.09|
72507504|NCT00406315|144546642|SUPERIORITY_OR_OTHER_LEGACY||Mean|134.8|||||TWO_SIDED|95.0|-20.43|289.98||||||The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.||289.98|-20.43|
72507505|NCT00406315|144546643|SUPERIORITY_OR_OTHER_LEGACY||Mean|-2.9|||||TWO_SIDED|95.0|-5.93|0.11||||||Waist. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.||0.11|-5.93|
72507506|NCT00406315|144546643|SUPERIORITY_OR_OTHER_LEGACY||Mean|-3.0|||||TWO_SIDED|95.0|-6.2|0.1||||||Hip. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.||0.10|-6.20|
72507507|NCT00406315|144546644|SUPERIORITY_OR_OTHER_LEGACY||Mean|0.05|||||TWO_SIDED|95.0|-0.32|0.42||||||Total Score. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.||0.42|-0.32|
72566165|NCT01045993|144663003|SUPERIORITY_OR_OTHER|||||||0.419||95.0||||Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05.|ANOVA|P-value from ANOVA model with treatment term only in the model.||At Minus 5 degrees||||0.419
72566166|NCT01045993|144663003|SUPERIORITY_OR_OTHER|||||||0.086||95.0||||Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05.|ANOVA|P-value from ANOVA model with treatment term only in the model.||At Plus 5 degrees (beyond maximum)||||0.086
72566167|NCT01045993|144663004|SUPERIORITY_OR_OTHER|||||||0.067||95.0||||Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05.|ANOVA|P-value from ANOVA model with treatment term only in the model.||At Maximum degrees||||0.067
72475291|NCT04410523|144475572|SUPERIORITY||Least Squares mean|0.033|STANDARD_ERROR_OF_MEAN|0.118||0.778|TWO_SIDED|95.0|-0.199|0.265|||MMRM||Treatment difference (CCSJ117-placebo)|||0.265|-0.199|0.778
72475292|NCT04410523|144475572|SUPERIORITY||Least Squares mean|0.073|STANDARD_ERROR_OF_MEAN|0.118||0.539|TWO_SIDED|95.0|-0.16|0.305|||MMRM||Treatment difference (CCSJ117-placebo)|||0.305|-0.160|0.539
72475293|NCT03651622|144475593|SUPERIORITY|||||||0.98|||||||ANOVA|||||||0.98
72475294|NCT03651622|144475594|SUPERIORITY|||||||0.85|||||||ANOVA|||||||0.85
72475295|NCT03651622|144475595|SUPERIORITY|||||||0.4|||||||ANOVA|||||||0.40
72475296|NCT03651622|144475596|SUPERIORITY|||||||0.02|||||||ANOVA|||||||0.02
72475297|NCT03651622|144475597|SUPERIORITY|||||||0.38|||||||ANOVA|||||||0.38
72475298|NCT03651622|144475598|SUPERIORITY|||||||0.18|||||||ANOVA|||||||0.18
72475299|NCT03651622|144475599|SUPERIORITY|||||||0.79|||||||ANOVA|||||||0.79
72475300|NCT03651622|144475600|SUPERIORITY|||||||0.39|||||||ANOVA|||The proposed sample size of n=72 was sufficient to ensure 60% power to detect a moderate effect size (Cohen h=0.68) and 80% to detect a large effect size (Cohen h=0.85) at a significance level of 0.10 for comparing difference in change among the 3 diets. By design, our primary goal for this pilot work is to inform the final efficacy design of a fully powered SMART, and the pilot SMART was therefore not designed to be fully powered for all analyses.||||0.39
72475301|NCT03651622|144475601|SUPERIORITY|||||||0.75|||||||ANOVA|||||||0.75
72475302|NCT03651622|144475602|SUPERIORITY|||||||0.66|||||||ANOVA|||||||0.66
72475303|NCT03651622|144475603|SUPERIORITY|||||||0.96|||||||ANOVA|||||||0.96
72475304|NCT03651622|144475604|SUPERIORITY|||||||0.34|||||||ANOVA|||||||0.34
72475305|NCT03651622|144475605|SUPERIORITY|||||||0.58|||||||ANOVA|||||||0.58
72475306|NCT03651622|144475606|SUPERIORITY|||||||0.95|||||||ANOVA|||||||0.95
72507508|NCT00406315|144546644|SUPERIORITY_OR_OTHER_LEGACY||Mean|0.03|||||TWO_SIDED|95.0|-0.05|0.11||||||Global Severity Score. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.||0.11|-0.05|
72507509|NCT00406315|144546644|SUPERIORITY_OR_OTHER_LEGACY||Mean|0.01|||||TWO_SIDED|95.0|-0.06|0.07||||||Global Incapacitation Score. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.||0.07|-0.06|
72507510|NCT00406315|144546645|SUPERIORITY_OR_OTHER_LEGACY||Mean|-10.22|||||TWO_SIDED|95.0|-12.7|-7.75||||||Total Score, Week 16. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.||-7.75|-12.70|
72507511|NCT00406315|144546645|SUPERIORITY_OR_OTHER_LEGACY||Mean|-6.61|||||TWO_SIDED|95.0|-8.59|-4.63||||||Total Score, Week 16 LOCF. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.||-4.63|-8.59|
72507512|NCT00406315|144546645|SUPERIORITY_OR_OTHER_LEGACY||Mean|-3.3|||||TWO_SIDED|95.0|-4.07|-2.53||||||Positive Subscale Score, Week 16. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.||-2.53|-4.07|
72566168|NCT01045993|144663004|SUPERIORITY_OR_OTHER|||||||0.757||95.0||||Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05.|ANOVA|P-value from ANOVA model with treatment term only in the model.||At Minus 5 degrees||||0.757
72398639|NCT00597766|144303766|SUPERIORITY_OR_OTHER||group x time interaction|-0.02||||0.9|TWO_SIDED|95.0||||Comparison 40mg vs. 20mg: F (1,35)=0.0, p=0.9|linear mixed model|1st order antedependence covariance structure||This study was not powered for secondary outcomes.The effect of treatment group over time was analyzed using a linear mixed model for repeated measures with random intercept and subject effects. The dependent variable was treatment group and variables for week (continuous) and group interaction term was included in the model. The effect of treatment at discrete time points was analyzed using a linear mixed model with categorical time.||||0.9
72398640|NCT00597766|144303767|SUPERIORITY_OR_OTHER||Groupxtime interaction|1.3||||0.2|TWO_SIDED|95.0||||Comparison 60mg vs. 20mg: F (1,36)=1.6, p=0.2|linear mixed model|unstructured covariance structure||The study was not powered for secondary analyses. The effect of treatment group over time was analyzed using a linear mixed model for repeated measures with random intercept and subject effects. The dependent variable was treatment group and variables for week (continuous) and group interaction term was included in the model. The effect of treatment at discrete time points was analyzed using a linear mixed model with categorical time.||||0.2
72475307|NCT03651622|144475607|SUPERIORITY|||||||0.08|||||||ANOVA|||||||0.08
72398641|NCT00597766|144303767|SUPERIORITY_OR_OTHER||Groupxtime interaction|1.1||||0.3|TWO_SIDED|95.0||||Comparison 40mg vs. 20mg: F (1,35)=1.0, p=0.3|linear mixed model|Unstructured covariance structure||Secondary outcomes were not powered for analysis. The effect of treatment group over time was analyzed using a linear mixed model for repeated measures with random intercept and subject effects. The dependent variable was treatment group and variables for week (continuous) and group interaction term was included in the model. The effect of treatment at discrete time points was analyzed using a linear mixed model with categorical time.||||0.3
72398642|NCT00597766|144303768|SUPERIORITY_OR_OTHER||group x time interaction|0.4||||0.8|TWO_SIDED|95.0||||Comparison 60mg vs. 20mg: F (1,36)=0.06, p=0.8|linear mixed model|first order antedepentent covariance structure||This study was not powered for secondary outcomes.The effect of treatment group over time was analyzed using a linear mixed model for repeated measures with random intercept and subject effects. The dependent variable was treatment group and variables for week (continuous) and group interaction term was included in the model. The effect of treatment at discrete time points was analyzed using a linear mixed model with categorical time.||||0.8
72398643|NCT00597766|144303768|SUPERIORITY_OR_OTHER||group x time interaction|1.7||||0.3|TWO_SIDED|95.0||||Comparison 40mg vs. 20mg: F (1,35)=1.1, p=0.3|linear mixed model|first order antedependent covariance structure||This study was not powered for secondary outcomes.The effect of treatment group over time was analyzed using a linear mixed model for repeated measures with random intercept and subject effects. The dependent variable was treatment group and variables for week (continuous) and group interaction term was included in the model. The effect of treatment at discrete time points was analyzed using a linear mixed model with categorical time.||||0.3
72398644|NCT01857232|144303791|SUPERIORITY|||||||0.004|||||||Regression, Logistic|||||||0.004
72398645|NCT01857232|144303791|SUPERIORITY|||||||0.0987|||||||Regression, Logistic|||||||0.0987
72398646|NCT01857232|144303791|SUPERIORITY|||||||0.1041|||||||Regression, Logistic|||||||0.1041
72398647|NCT01857232|144303792|SUPERIORITY|||||||0.0235|||||||Chi-squared, Corrected|1-sided||||||0.0235
72398648|NCT01857232|144303792|SUPERIORITY|||||||0.1651|||||||Chi-squared, Corrected|1-sided||||||0.1651
72398649|NCT01857232|144303792|SUPERIORITY|||||||0.1332|||||||Chi-squared, Corrected|1-sided||||||0.1332
72398650|NCT00416078|144303793|SUPERIORITY_OR_OTHER|||||||0.65|TWO_SIDED|||||F test of time X group effect F(1,3)=.26|Mixed Models Analysis|||intent to treat||||.65
72398651|NCT00416078|144303794|SUPERIORITY_OR_OTHER|||||||0.51|TWO_SIDED|||||t test of differential change over time in the two groups t(30)=.67|Mixed Models Analysis|||intent to treat analysis||||.51
72398652|NCT00416078|144303795|SUPERIORITY_OR_OTHER|||||||0.79|TWO_SIDED|||||t test of differential change over time in the two groups t(29)=.27|Mixed Models Analysis|||intent to treat analysis||||.79
72398653|NCT00416078|144303796|SUPERIORITY_OR_OTHER|||||||0.49|TWO_SIDED|||||t test for differential change over time in the two groups t(29)=.70|Mixed Models Analysis|||intent to treat analysis||||.49
72398654|NCT00416078|144303797|SUPERIORITY_OR_OTHER|||||||0.67|TWO_SIDED|||||t test for differential change over time in the two groups t(29)=.43|Mixed Models Analysis|||intent to treat analysis||||.67
72475308|NCT00127205|144475646|OTHER|||||||0.49|||||||Log Rank|||||||0.49
72475309|NCT00127205|144475646|SUPERIORITY||Hazard Ratio (HR)|1.09||||0.24|TWO_SIDED|95.0|0.94|1.26|||Regression, Cox|||||1.26|0.94|0.24
72475310|NCT00127205|144475646|SUPERIORITY||Hazard Ratio (HR)|1.06||||0.5|TWO_SIDED|95.0|0.9|1.24|||Regression, Cox|||||1.24|0.90|0.50
72475311|NCT00127205|144475647|OTHER|||||||0.5|||||||Log Rank|||||||0.50
72475312|NCT00127205|144475648|OTHER|||||||0.93|||||||Log Rank|||Statistical analysis for recurrence to bone||||0.93
72475313|NCT03582943|144475653|SUPERIORITY|A priori power analyses was designed to detect at least a 3 second difference in change in balance scores between groups.|Mean Difference (Net)|0.74||||0.984|TWO_SIDED|||||Test of differences between groups.|Mixed Models Analysis|||||||0.984
72475314|NCT03582943|144475653|SUPERIORITY||Mean Difference (Net)|-0.023||||0.455|TWO_SIDED|||||Test of interaction between age and RLIC vs. sham|Mixed Models Analysis|||||||.455
72475315|NCT03582943|144475653|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.803|TWO_SIDED|||||Test of interaction between sex and RLIC vs. sham conditioning|Mixed Models Analysis|||||||0.803
72475316|NCT03582943|144475653|SUPERIORITY||Mean Difference (Net)|0.25||||0.233|TWO_SIDED|||||Test of interaction between BMI and RLIC vs. sham conditioning|Mixed Models Analysis|||||||0.233
72475317|NCT03582943|144475653|SUPERIORITY|Test of interaction between presence of co-morbidities and RLIC vs. sham conditioning|Mean Difference (Net)|4.12||||0.29|TWO_SIDED||||||Mixed Models Analysis|||||||0.29
72475318|NCT05126563|144475658|SUPERIORITY||LS Means|0.054|STANDARD_ERROR_OF_MEAN|0.738||0.9416|TWO_SIDED|95.0|-1.42|1.53|||ANCOVA||The value described represents the difference value of the mean change from baseline between HB-adMSC and Placebo groups|The null hypothesis is that the difference in change from baseline to Weeks 26 in Visual Analog Scale of Neurological Symptoms - Extreme fatigue scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero.||1.53|-1.42|0.9416
72507513|NCT00406315|144546645|SUPERIORITY_OR_OTHER_LEGACY||Mean|-2.43|||||TWO_SIDED|95.0|-3.03|-1.83||||||Positive Subscale Score, Week 16 LOCF. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.||-1.83|-3.03|
72398655|NCT00416078|144303798|SUPERIORITY_OR_OTHER|||||||0.64|TWO_SIDED||||||Fisher Exact|||||||.64
72398656|NCT00969150|144303837|SUPERIORITY_OR_OTHER||Least squares mean difference|-1.49||||0.2492|TWO_SIDED|95.0|-4.02|1.05|||Mixed Models Analysis|Mixed-effects model for repeated measures.||||1.05|-4.02|0.2492
72398657|NCT00969150|144303838|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.54||||0.5625|TWO_SIDED|95.0|-2.38|1.29|||Mixed Models Analysis|Mixed-effects model for repeated measures.||||1.29|-2.38|0.5625
72398658|NCT01698801|144303849|SUPERIORITY_OR_OTHER||Overall dichotomized response rate|87.5|||<|0.0001|TWO_SIDED|95.0|74.269|100.0||One sample binomial test for the overall response rate was performed to provide p-value (significance level: 0.05) based on EE population. The hypotheses of interest are: H0: p = 0.3, H1: p ≠ 0.3, where p is overall response.|Binomial test for dichotomized response|||||100|74.269|<0.0001
72475319|NCT05126563|144475659|SUPERIORITY||LS Means|-0.172|STANDARD_ERROR_OF_MEAN|0.685||0.8021|TWO_SIDED|95.0|-1.54|1.2|||ANCOVA||The value described represents the difference value of the mean change from baseline between HB-adMSC and Placebo groups|The null hypothesis is that the difference in change from baseline to Weeks 26 in Visual Analog Scale of Neurological Symptoms - Brain fog scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero.||1.20|-1.54|0.8021
72475320|NCT05126563|144475660|SUPERIORITY||LS Means|0.399|STANDARD_ERROR_OF_MEAN|0.515||0.4417|TWO_SIDED|95.0|-0.63|1.43|||ANCOVA||The value described represents the difference value of the mean change from baseline between HB-adMSC and Placebo groups|The null hypothesis is that the difference in change from baseline to Weeks 26 in Visual Analog Scale of Neurological Symptoms. - Headache scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero.||1.43|-0.63|0.4417
72507514|NCT00406315|144546645|SUPERIORITY_OR_OTHER_LEGACY||Mean|-1.67|||||TWO_SIDED|95.0|-2.36|-0.99||||||Negative Subscale Score, Week 16. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.||-0.99|-2.36|
72507515|NCT00406315|144546645|SUPERIORITY_OR_OTHER_LEGACY||Mean|-0.92|||||TWO_SIDED|95.0|-1.48|-0.35||||||Negative Subscale Score, Week 16 LOCF. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.||-0.35|-1.48|
72507516|NCT00406315|144546646|SUPERIORITY_OR_OTHER_LEGACY||Mean|-0.76|||||TWO_SIDED|95.0|-0.9|-0.61||||||Week 16. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.||-0.61|-0.90|
72507517|NCT00406315|144546646|SUPERIORITY_OR_OTHER_LEGACY||Mean|-0.47|||||TWO_SIDED|95.0|-0.58|-0.36||||||Week 16 LOCF. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.||-0.36|-0.58|
72507518|NCT00406315|144546647|SUPERIORITY_OR_OTHER_LEGACY||Mean|2.7|||||TWO_SIDED|95.0|2.52|2.88||||||Week 16. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.||2.88|2.52|
72507519|NCT00406315|144546647|SUPERIORITY_OR_OTHER_LEGACY||Mean|3.2|||||TWO_SIDED|95.0|3.02|3.34||||||Week 16 LOCF. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.||3.34|3.02|
72507520|NCT00406315|144546648|SUPERIORITY_OR_OTHER_LEGACY||Mean|-2.55|||||TWO_SIDED|95.0|-3.27|-1.83||||||Week 16. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.||-1.83|-3.27|
72398659|NCT00680043|144303874|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.25|STANDARD_ERROR_OF_MEAN|0.238|||TWO_SIDED|97.5|-0.79|0.29|||ANOVA|||||0.29|-0.79|
72398660|NCT00680043|144303874|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.238|||TWO_SIDED|97.5|-0.56|0.52|||ANOVA|||||0.52|-0.56|
72398661|NCT00680043|144303876|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.92|||||TWO_SIDED|95.0|0.84|1.01|||Cochran-Mantel-Haenszel|||||1.01|0.84|
72475321|NCT05126563|144475661|SUPERIORITY||Slope|0.542|STANDARD_ERROR_OF_MEAN|0.721||0.455|TWO_SIDED|95.0|-0.9|1.98|||ANCOVA|||The null hypothesis is that the difference in change from baseline to Weeks 26 in Visual Analog Scale of Neurological Symptoms - Sleep disturbances scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero.||1.98|-0.90|0.4550
72398662|NCT00680043|144303876|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.97|||||TWO_SIDED|95.0|0.92|1.03|||Cochran-Mantel-Haenszel|||||1.03|0.92|
72398663|NCT03761147|144303908|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
72398664|NCT03232281|144303987|NON_INFERIORITY|If the lower limit of the 95% CI for the difference was \>-10%, triptorelin pamoate PR 3-month non-inferiority to triptorelin acetate PR 1-month was confirmed.|Rate difference (%)|-0.7|||||TWO_SIDED|95.0|-4.41|2.58|||||The rate difference (triptorelin pamoate PR 3-month - triptorelin acetate PR 1-month) and the 2-sided 95% CI of the difference were calculated using the Miettinen and Nurminen method, stratified by randomisation stratification factors.|The null hypothesis was that triptorelin pamoate PR 3-month was inferior to triptorelin acetate PR 1-month. The alternative hypothesis was that triptorelin pamoate PR 3-month was non-inferior to triptorelin acetate PR 1-month.||2.58|-4.41|
72475322|NCT05126563|144475662|SUPERIORITY||LS Means|-0.047|STANDARD_ERROR_OF_MEAN|0.466||0.92|TWO_SIDED|95.0|-0.98|0.89|||ANCOVA||The value described represents the difference value of the mean change from baseline between HB-adMSC and Placebo groups|The null hypothesis is that the difference in change from baseline to Weeks 26 in Visual Analog Scale of Neurological Symptoms - Loss of taste scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero.||0.89|-0.98|0.9200
72507521|NCT00406315|144546648|SUPERIORITY_OR_OTHER_LEGACY||Mean|-1.58|||||TWO_SIDED|95.0|-2.16|-0.99||||||Week 16 LOCF. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.||-0.99|-2.16|
72507522|NCT00406315|144546649|SUPERIORITY_OR_OTHER_LEGACY||Mean|-4.61|||||TWO_SIDED|95.0|-5.95|-3.26||||||Total Score, Week 16. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.||-3.26|-5.95|
72507523|NCT00406315|144546649|SUPERIORITY_OR_OTHER_LEGACY||Mean|-4.21|||||TWO_SIDED|95.0|-5.57|-2.85||||||Total Score, Week 16 LOCF. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.||-2.85|-5.57|
72507524|NCT00406315|144546649|SUPERIORITY_OR_OTHER_LEGACY||Mean|-1.02|||||TWO_SIDED|95.0|-1.31|-0.73||||||Global Rating, Week 16. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.||-0.73|-1.31|
72475323|NCT05126563|144475663|SUPERIORITY||LS Means|-0.16|STANDARD_ERROR_OF_MEAN|0.36||0.6589|TWO_SIDED|95.0|-0.88|0.56|||ANCOVA||The value described represents the difference value of the mean change from baseline between HB-adMSC and Placebo groups|The null hypothesis is that the difference in change from baseline to Weeks 26 in PHQ-9 scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero.||0.56|-0.88|0.6589
72475324|NCT05126563|144475664|SUPERIORITY||LS Means|0.162|STANDARD_ERROR_OF_MEAN|0.725||0.824|TWO_SIDED|95.0|-1.29|1.61|||RMA||The value described represents the difference value of the mean change from baseline between HB-adMSC and Placebo groups|The null hypothesis is that the difference in change from baseline to Weeks 26 in Visual Analog Scale of Neurological Symptoms Extreme Fatigue scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero.||1.61|-1.29|0.8240
72475325|NCT05126563|144475665|SUPERIORITY||LS Means|-0.009|STANDARD_ERROR_OF_MEAN|0.686||0.9892|TWO_SIDED|95.0|-1.38|1.36|||RMA||The value described represents the difference value of the mean change from baseline between HB-adMSC and Placebo groups|The null hypothesis is that the difference in change from baseline to Weeks 26 in Visual Analog Scale of Neurological Symptoms - Brain Fog scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero.||1.36|-1.38|0.9892
72475326|NCT05126563|144475666|SUPERIORITY||LS Means|0.439|STANDARD_ERROR_OF_MEAN|0.513||0.3952|TWO_SIDED|95.0|-0.59|1.47|||RMA||The value described represents the difference value of the mean change from baseline between HB-adMSC and Placebo groups|The null hypothesis is that the difference in change from baseline to Weeks 26 in Visual Analog Scale of Neurological Symptoms - Headache scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero.||1.47|-0.59|0.3952
72475327|NCT05126563|144475667|SUPERIORITY||LS Means|0.535|STANDARD_ERROR_OF_MEAN|0.704||0.4504|TWO_SIDED|95.0|-0.87|1.94|||RMA||The value described represents the difference value of the mean change from baseline between HB-adMSC and Placebo groups|The null hypothesis is that the difference in change from baseline to Weeks 26 in Visual Analog Scale of Neurological Symptoms - Sleep Disturbances scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero.||1.94|-0.87|0.4504
72475328|NCT05126563|144475668|SUPERIORITY||LS Means|-0.161|STANDARD_ERROR_OF_MEAN|0.469||0.7318|TWO_SIDED|95.0|-1.1|0.78|||RMA||The value described represents the difference value of the mean change from baseline between HB-adMSC and Placebo groups|The null hypothesis is that the difference in change from baseline to Weeks 26 in Visual Analog Scale of Neurological Symptoms - Loss of Taste scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero.||0.78|-1.10|0.7318
72475329|NCT05126563|144475669|SUPERIORITY||LS Means|-0.215|STANDARD_ERROR_OF_MEAN|0.357||0.5485|TWO_SIDED|95.0|-0.93|0.5|||RMA||The value described represents the difference value of the mean change from baseline between HB-adMSC and Placebo groups|The null hypothesis is that the difference in change from baseline to Weeks 26 in Visual Analog Scale of Neurological Symptoms - Loss of Smell scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero.||0.50|-0.93|0.5485
72507525|NCT00406315|144546649|SUPERIORITY_OR_OTHER_LEGACY||Mean|-0.88|||||TWO_SIDED|95.0|-1.13|-0.63||||||Global Rating, Week 16 LOCF. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.||-0.63|-1.13|
72507526|NCT00406315|144546650|SUPERIORITY_OR_OTHER_LEGACY||Mean|7.88|||||TWO_SIDED|95.0|6.07|9.69||||||Week 16. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.||9.69|6.07|
72507527|NCT00406315|144546650|SUPERIORITY_OR_OTHER_LEGACY||Mean|5.27|||||TWO_SIDED|95.0|3.89|6.65||||||Week 16 LOCF. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.||6.65|3.89|
72475330|NCT05126563|144475700|SUPERIORITY||LS Means|-0.377|STANDARD_ERROR_OF_MEAN|0.407||0.3577|TWO_SIDED|95.0|-1.19|0.44|||ANCOVA||The value described represents the difference value of the mean change from baseline between HB-adMSC and Placebo groups|The null hypothesis is that the difference in change from baseline to Weeks 26 in Visual Analog Scale of Non-Neurological Symptoms. - Dyspnea at rest scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero.||0.44|-1.19|0.3577
72475331|NCT05126563|144475701|SUPERIORITY||LS Means|-0.203|STANDARD_ERROR_OF_MEAN|0.563||0.7196|TWO_SIDED|95.0|-1.33|0.92|||ANCOVA||The value described represents the difference value of the mean change from baseline between HB-adMSC and Placebo groups|The null hypothesis is that the difference in change from baseline to Weeks 26 in Visual Analog Scale of Non-Neurological Symptoms. - Dyspnea during activity scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero.||0.92|-1.33|0.7196
72475332|NCT05126563|144475702|SUPERIORITY||LS Means|-0.306|STANDARD_ERROR_OF_MEAN|0.435||0.4847|TWO_SIDED|95.0|-1.18|0.56|||ANCOVA||The value described represents the difference value of the mean change from baseline between HB-adMSC and Placebo groups|The null hypothesis is that the difference in change from baseline to Weeks 26 in Visual Analog Scale of Non-Neurological Symptoms. - Cough scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero.||0.56|-1.18|0.4847
72475333|NCT05126563|144475703|SUPERIORITY||LS Means|0.619|STANDARD_ERROR_OF_MEAN|0.661||0.3535|TWO_SIDED|95.0|-0.71|1.94|||ANCOVA||The value described represents the difference value of the mean change from baseline between HB-adMSC and Placebo groups|The null hypothesis is that the difference in change from baseline to Weeks 26 in Visual Analog Scale of Non-Neurological Symptoms. - Body aches scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero.||1.94|-0.71|0.3535
72475334|NCT05126563|144475704|SUPERIORITY||LS Means|0.472|STANDARD_ERROR_OF_MEAN|0.655||0.4746|TWO_SIDED|95.0|-0.84|1.78|||ANCOVA||The value described represents the difference value of the mean change from baseline between HB-adMSC and Placebo groups|The null hypothesis is that the difference in change from baseline to Weeks 26 in Visual Analog Scale of Non-Neurological Symptoms. - Joint Pain scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero.||1.78|-0.84|0.4746
72475335|NCT05126563|144475705|SUPERIORITY||LS Means|-1.433|STANDARD_ERROR_OF_MEAN|2.141||0.5059|TWO_SIDED|95.0|-5.72|2.85|||ANCOVA||The value described represents the difference value of the mean change from baseline between HB-adMSC and Placebo groups|The null hypothesis is that the difference in change from baseline to Weeks 26 in Subject's energy - Fatigue Assessment form scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero.||2.85|-5.72|0.5059
72507528|NCT00406315|144546651|SUPERIORITY_OR_OTHER_LEGACY||Mean|10.49|||||TWO_SIDED|95.0|5.95|15.02||||||Effectiveness, Week 16. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.||15.02|5.95|
72507529|NCT00406315|144546651|SUPERIORITY_OR_OTHER_LEGACY||Mean|10.49|||||TWO_SIDED|95.0|5.95|15.02||||||Effectiveness, Week 16 LOCF. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.||15.02|5.95|
72475336|NCT05126563|144475706|SUPERIORITY||LS Means|-6.095|STANDARD_ERROR_OF_MEAN|4.99||0.2269|TWO_SIDED|95.0|-16.08|3.89|||ANCOVA||The value described represents the difference value of the mean change from baseline between HB-adMSC and Placebo groups.|The null hypothesis is that the difference in change from baseline to Weeks 26 in Short Form 36 Health Survey Questionnaire (General Health) between treatment groups (HB-adMSCs - Placebo) is equal to zero.||3.89|-16.08|0.2269
72475337|NCT05126563|144475707|SUPERIORITY||LS Means|-0.122|STANDARD_ERROR_OF_MEAN|1.392||0.8735|TWO_SIDED|95.0|-2.91|2.66|||ANCOVA||The value described represents the difference value of the mean change from baseline between HB-adMSC and Placebo groups|The null hypothesis is that the difference in change from baseline to Weeks 26 in PHQ-9 scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero.||2.66|-2.91|0.8735
72475338|NCT05126563|144475708|SUPERIORITY||LS Means|-3.424|STANDARD_ERROR_OF_MEAN|4.82||0.4802|TWO_SIDED|95.0|-13.07|6.22|||ANCOVA||The value described represents the difference value of the mean change from baseline between HB-adMSC and Placebo groups|The null hypothesis is that the difference in change from baseline to Weeks 26 in PHQ-9 scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero.||6.22|-13.07|0.4802
72475339|NCT06612255|144475709|OTHER|Ratio (%) of adjusted geometric means with comparison presented as test (powder)/reference (tablet).|Fixed Effect Analysis|51.68|||||TWO_SIDED|90.0|45.71|58.43||||||Results obtained from mixed effects model of natural log transformed pharmacokinetic parameters including terms for regimen, period and sequence fitted as fixed effects and subject nested within sequence fitted as a random effect.||58.43|45.71|
72475340|NCT05032872|144475713|SUPERIORITY|||||||0.49||||||Controlled for age, sex, education, and self-reported functional health|Mixed Models Analysis|||Time by condition interaction||||.49
72475341|NCT05032872|144475714|SUPERIORITY|||||||0.48||||||Controlled for age, sex, education, and self-reported functional health|Mixed Models Analysis|||Time x condition interaction||||.48
72507530|NCT00406315|144546651|SUPERIORITY_OR_OTHER_LEGACY||Mean|18.49|||||TWO_SIDED|95.0|11.94|25.04||||||Side Effect, Week 16. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.||25.04|11.94|
72507531|NCT00406315|144546651|SUPERIORITY_OR_OTHER_LEGACY||Mean|18.49|||||TWO_SIDED|95.0|11.94|25.04||||||Side Effect, Week 16 LOCF. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.||25.04|11.94|
72475342|NCT05032872|144475715|SUPERIORITY|||||||0.04||||||Controlled for age, sex, education, and self-reported functional health|Mixed Models Analysis|||Time x condition interaction predicting satisfaction with contact quality||||.04
72475343|NCT05032872|144475715|SUPERIORITY|||||||0.44||||||Controlled for age, sex, education, and self-reported functional health|Mixed Models Analysis|||Time x condition interaction predicting dissatisfaction with contact quantity||||.44
72475344|NCT05032872|144475715|SUPERIORITY|||||||0.99||||||Controlled for age, sex, education, and self-reported functional health|Mixed Models Analysis|||Time x condition interaction predicting satisfaction with contact quantity||||.99
72475345|NCT05032872|144475715|SUPERIORITY|||||||0.87||||||Controlled for age, sex, education, and self-reported functional health|Mixed Models Analysis|||Time x condition interaction predicting knowing others' experience||||.87
72475346|NCT05032872|144475715|SUPERIORITY|||||||0.98||||||Controlled for age, sex, education, and self-reported functional health|Mixed Models Analysis|||Time x condition interaction predicting shared understanding||||.98
72507532|NCT00406315|144546651|SUPERIORITY_OR_OTHER_LEGACY||Mean|6.45|||||TWO_SIDED|95.0|2.98|9.93||||||Convenience, Week 16. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.||9.93|2.98|
72507533|NCT00406315|144546651|SUPERIORITY_OR_OTHER_LEGACY||Mean|6.45|||||TWO_SIDED|95.0|2.98|9.93||||||Convenience, Week 16 LOCF. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.||9.93|2.98|
72507534|NCT00406315|144546651|SUPERIORITY_OR_OTHER_LEGACY||Mean|15.32|||||TWO_SIDED|95.0|9.97|20.68||||||Global Satisfaction, Week 16. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.||20.68|9.97|
72475347|NCT05032872|144475715|SUPERIORITY|||||||0.76||||||Controlled for age, sex, education, and self-reported functional health|Mixed Models Analysis|||Time x condition interaction predicting relationship salience||||.76
72475348|NCT05032872|144475716|SUPERIORITY|||||||0.29||||||Controlled for age, sex, education, and self-reported functional health|Mixed Models Analysis|||Time x condition interaction||||.29
72475349|NCT05032872|144475717|SUPERIORITY|||||||0.51||||||Controlled for age, sex, education, and self-reported functional health|Mixed Models Analysis|||Time x condition predicting positive affect||||.51
72475350|NCT05032872|144475717|SUPERIORITY|||||||0.83||||||Controlled for age, sex, education, and self-reported functional health|Mixed Models Analysis|||Time x condition predicting negative affect||||.83
72475351|NCT05032872|144475718|SUPERIORITY|||||||0.51||||||Controlled for age, sex, education, and self-reported functional health|Mixed Models Analysis|||Time x condition interaction||||.51
72475352|NCT05032872|144475719|SUPERIORITY|||||||0.65||||||Controlled for age, sex, education, and self-reported functional health|Mixed Models Analysis|||Time x condition interaction||||.65
72475353|NCT05032872|144475720|SUPERIORITY|||||||0.01||||||Controlled for age, sex, education, and self-reported functional health|Mixed Models Analysis|||Time x condition interaction predicting management of distress||||.01
72475354|NCT05032872|144475720|SUPERIORITY|||||||0.75||||||Controlled for age, sex, education, and self-reported functional health|Mixed Models Analysis|||time x condition interaction predicting caregiver overload||||.75
72475355|NCT05032872|144475720|SUPERIORITY|||||||0.59||||||Controlled for age, sex, education, and self-reported functional health|Mixed Models Analysis|||Time x condition interaction predicting relational deprivation||||.59
72507535|NCT00406315|144546651|SUPERIORITY_OR_OTHER_LEGACY||Mean|15.32|||||TWO_SIDED|95.0|9.97|20.68||||||Global Satisfaction, Week 16 LOCF. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.||20.68|9.97|
72475356|NCT05032872|144475720|SUPERIORITY|||||||0.51||||||Controlled for age, sex, education, and self-reported functional health|Mixed Models Analysis|||Time x condition interaction predicting job caregiving conflict||||.51
72475357|NCT05032872|144475720|SUPERIORITY|||||||0.25||||||Controlled for age, sex, education, and self-reported functional health|Mixed Models Analysis|||Time x condition interaction predicting role captivity||||.25
72475358|NCT05032872|144475720|SUPERIORITY|||||||0.34||||||Controlled for age, sex, education, and self-reported functional health|Mixed Models Analysis|||Time x condition interaction predicting sense of self||||.34
72398665|NCT03232281|144303988|NON_INFERIORITY|If the lower limit of the 95% CI for the difference was \>-10%, triptorelin pamoate PR 3-month non-inferiority to triptorelin acetate PR 1-month was observed without multiplicity adjustment.|Rate difference (%)|-1.3|||||TWO_SIDED|95.0|-5.26|1.93|||||The rate difference (triptorelin pamoate PR 3-month - triptorelin acetate PR 1-month) and the 2-sided 95% CI of the difference were calculated using the Miettinen and Nurminen method, stratified by randomisation stratification factors.|Rate difference at Week 4. The null hypothesis was that triptorelin pamoate PR 3-month was inferior to triptorelin acetate PR 1-month. The alternative hypothesis was that triptorelin pamoate PR 3-month was non-inferior to triptorelin acetate PR 1-month.||1.93|-5.26|
72475359|NCT05032872|144475720|SUPERIORITY|||||||0.75||||||Controlled for age, sex, education, and self-reported functional health|Mixed Models Analysis|||Time x condition interaction predicting personal gain||||.75
72475360|NCT05032872|144475720|SUPERIORITY|||||||0.99||||||Controlled for age, sex, education, and self-reported functional health|Mixed Models Analysis|||Time x condition interaction predicting caregiving competence||||.99
72475361|NCT05032872|144475720|SUPERIORITY|||||||0.61||||||Controlled for age, sex, education, and self-reported functional health|Mixed Models Analysis|||Time x condition interaction predicting management of situition||||.61
72475362|NCT05032872|144475720|SUPERIORITY|||||||0.92||||||Controlled for age, sex, education, and self-reported functional health|Mixed Models Analysis|||Time x condition interaction predicting management of meaning||||.92
72475363|NCT05032872|144475720|SUPERIORITY|||||||0.96||||||Controlled for age, sex, education, and self-reported functional health|Mixed Models Analysis|||Time x condition interaction predicting expressive support||||.96
72475364|NCT05032872|144475721|SUPERIORITY|||||||0.37||||||Controlled for age, sex, education, and self-reported functional health|Mixed Models Analysis|||Time x condition interaction||||.37
72475365|NCT05032872|144475722|SUPERIORITY|||||||0.89||||||Controlled for age, sex, education, and self-reported functional health|Mixed Models Analysis|||Time x condition interaction||||.89
72475366|NCT05032872|144475723|SUPERIORITY|||||||0.3||||||Controlled for age, sex, education, and self-reported functional health|Mixed Models Analysis|||Time x condition interaction||||.30
72475367|NCT05032872|144475724|SUPERIORITY|||||||0.52||||||Controlled for age, sex, education, and self-reported functional health|Mixed Models Analysis|||Time x condition interaction||||.52
72475368|NCT05032872|144475725|SUPERIORITY|||||||0.45|||||||t-test, 2 sided|||Independent sample T-test comparing the treatment and control group||||.45
72475369|NCT02946853|144475773|SUPERIORITY||Odds Ratio (OR)|1.0||||1|TWO_SIDED|95.0|0.14|7.21|||Regression, Logistic|||||7.21|0.14|1.00
72475370|NCT02946853|144475774|SUPERIORITY||Mean Difference (Net)|-1.0||||0.974|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.974
72475371|NCT02946853|144475775|SUPERIORITY||Mean Difference (Net)|0.5||||1|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Some patients did not undergo 6 month echocardiogram due to restrictions related to COVID-19.||||1.00
72475372|NCT02946853|144475776|SUPERIORITY||Odds Ratio (OR)|1.0||||1|TWO_SIDED|95.0|0.1|84.4|||Fisher Exact|||||84.4|0.1|1.00
72475373|NCT02946853|144475777|SUPERIORITY||Odds Ratio (OR)|1.0||||1|TWO_SIDED||||||Fisher Exact|||||||1.00
72475374|NCT02946853|144475778|SUPERIORITY||Odds Ratio (OR)|0.0||||1|TWO_SIDED|95.0|0.0|42.0|||Fisher Exact|||||42.00|0.00|1.00
72475375|NCT02946853|144475779|SUPERIORITY||Mean Difference (Final Values)|20.6||||0.005|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.005
72475376|NCT02946853|144475780|SUPERIORITY||Median Difference (Final Values)|23.7||||0.565|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.565
72475377|NCT02946853|144475781|SUPERIORITY||Odds Ratio (OR)|0.0||||1|TWO_SIDED|95.0|0.0|42.0|||Fisher Exact|||||42.0|0.0|1.00
72475378|NCT03691909|144475786|OTHER|||||||0.743|||||||Wilcoxon-signed rank test|Effect Size: 0.09||||||0.743
72475379|NCT03691909|144475787|OTHER|||||||0.714|||||||Wilcoxon-signed rank test|Effect Size: 0.10||||||0.714
72475380|NCT03691909|144475788|OTHER|||||||0.183|||||||Wilcoxon-signed rank test|Effect Size: 0.37||||||0.183
72475381|NCT03691909|144475789|OTHER|||||||0.775|||||||Wilcoxon-signed rank test|Effect Size: 0.05||||||0.775
72475382|NCT03691909|144475790|OTHER|||||||0.0008|||||||Wilcoxon-signed rank test|Effect Size: 0.93||Tender Joint Count||||0.0008
72475383|NCT03691909|144475790|OTHER|||||||0.003|||||||Wilcoxon-signed rank test|Effect Size: 0.83||Swollen Joint Count||||0.003
72475384|NCT04150068|144475811|SUPERIORITY|The difference in percentage between 2 treatment groups was compared using an unconditional exact method using 2 invert 1-sided tests with an alpha level at 0.05 to evaluate superiority.|Percentage Difference|70.8|||<|0.0001|TWO_SIDED|95.0|34.9|90.0||The P value and 95% confidence interval (CI) for the point estimate of treatment difference in proportions was estimated and constructed using the Chan and Zhang method.|Chan & Zhang method|||||90.0|34.9|< 0.0001
72475385|NCT04679935|144475825|OTHER|Analysis was purely descriptive.|Difference|-3.74|STANDARD_ERROR_OF_MEAN|1.84|||TWO_SIDED|95.0|-7.47|-0.01|||MMRM model|||Week 40||-0.01|-7.47|
72475386|NCT04679935|144475825|OTHER|Analysis was purely descriptive.|Difference|-4.15|STANDARD_ERROR_OF_MEAN|2.3|||TWO_SIDED|95.0|-8.78|-0.48|||MMRM model|||Week 44||-0.48|-8.78|
72475387|NCT04679935|144475825|OTHER|Analysis was purely descriptive.|Difference|-5.35|STANDARD_ERROR_OF_MEAN|2.38|||TWO_SIDED|95.0|-10.13|-0.58|||MMRM model|||Week 48||-0.58|-10.13|
72475388|NCT04679935|144475825|OTHER|Analysis was purely descriptive.|Difference|-4.19|STANDARD_ERROR_OF_MEAN|2.28|||TWO_SIDED|95.0|-8.77|0.39|||MMRM model|||Week 52||0.39|-8.77|
72475389|NCT04679935|144475825|OTHER|Analysis was purely descriptive.|Difference|-4.36|STANDARD_ERROR_OF_MEAN|2.09|||TWO_SIDED|95.0|-8.56|-0.16|||MMRM model|||Mean of Week 40 to Week 52||-0.16|-8.56|
72475390|NCT04679935|144475833|OTHER|Analysis was purely descriptive.|Difference|-4.19|STANDARD_ERROR_OF_MEAN|2.28|||TWO_SIDED|95.0|-8.77|-0.39|||MMRM model|||Week 52||-0.39|-8.77|
72475391|NCT05116540|144475865|SUPERIORITY||Mean Difference (Final Values)|22.121|STANDARD_ERROR_OF_MEAN|4.616||0.0002|TWO_SIDED|95.0|12.282|31.959|||ANCOVA|||||31.959|12.282|0.0002
72398666|NCT03232281|144303988|NON_INFERIORITY|If the lower limit of the 95% CI for the difference was \>-10%, triptorelin pamoate PR 3-month non-inferiority to triptorelin acetate PR 1-month was observed without multiplicity adjustment.|Rate difference (%)|-2.7|||||TWO_SIDED|95.0|-6.8|-0.16|||||The rate difference (triptorelin pamoate PR 3-month - triptorelin acetate PR 1-month) and the 2-sided 95% CI of the difference were calculated using the Miettinen and Nurminen method, stratified by randomisation stratification factors.|Rate difference at Week 8. The null hypothesis was that triptorelin pamoate PR 3-month was inferior to triptorelin acetate PR 1-month. The alternative hypothesis was that triptorelin pamoate PR 3-month was non-inferior to triptorelin acetate PR 1-month.||-0.16|-6.80|
72398667|NCT03232281|144303989|NON_INFERIORITY|If the lower limit of the 95% CI for the difference was \>-10%, triptorelin pamoate PR 3-month non-inferiority to triptorelin acetate PR 1-month was observed without multiplicity adjustment.|Rate difference (%)|-1.3|||||TWO_SIDED|95.0|-5.26|1.93|||||The rate difference (triptorelin pamoate PR 3-month - triptorelin acetate PR 1-month) and the 2-sided 95% CI of the difference were calculated using the Miettinen and Nurminen method, stratified by randomisation stratification factors.|Rate difference at Week 4. The null hypothesis was that triptorelin pamoate PR 3-month was inferior to triptorelin acetate PR 1-month. The alternative hypothesis was that triptorelin pamoate PR 3-month was non-inferior to triptorelin acetate PR 1-month.||1.93|-5.26|
72398668|NCT03232281|144303989|NON_INFERIORITY|If the lower limit of the 95% CI for the difference was \>-10%, triptorelin pamoate PR 3-month non-inferiority to triptorelin acetate PR 1-month was observed without multiplicity adjustment.|Rate difference (%)|-4.1|||||TWO_SIDED|95.0|-8.93|-0.52|||||The rate difference (triptorelin pamoate PR 3-month - triptorelin acetate PR 1-month) and the 2-sided 95% CI of the difference were calculated using the Miettinen and Nurminen method, stratified by randomisation stratification factors.|Rate difference at Week 8. The null hypothesis was that triptorelin pamoate PR 3-month was inferior to triptorelin acetate PR 1-month. The alternative hypothesis was that triptorelin pamoate PR 3-month was non-inferior to triptorelin acetate PR 1-month.||-0.52|-8.93|
72475392|NCT05116540|144475866|SUPERIORITY||Mean Difference (Final Values)|15.764|STANDARD_ERROR_OF_MEAN|5.844||0.0166|TWO_SIDED|95.0|3.307|28.221|||ANCOVA|||||28.221|3.307|0.0166
72475393|NCT05116540|144475867|SUPERIORITY||Mean Difference (Final Values)|22.137|STANDARD_DEVIATION|4.962||0.9905|TWO_SIDED|95.0|12.361|32.006|||ANCOVA|||||32.006|12.361|0.9905
72475394|NCT05116540|144475868|SUPERIORITY||Mean Difference (Final Values)|15.747|STANDARD_DEVIATION|6.274||0.8292|TWO_SIDED|95.0|3.329|28.177|||ANCOVA|||||28.177|3.329|0.8292
72475395|NCT05116540|144475869|SUPERIORITY||Mean Difference (Final Values)|-1.554|STANDARD_ERROR_OF_MEAN|0.638||0.0278|TWO_SIDED|95.0|-2.914|-0.195|||ANCOVA|||||-0.195|-2.914|0.0278
72475396|NCT05116540|144475870|SUPERIORITY||Mean Difference (Final Values)|5.453|STANDARD_ERROR_OF_MEAN|2.757||0.0666|TWO_SIDED|95.0|-0.424|11.33|||ANCOVA|||||11.330|-0.424|0.0666
72475397|NCT05116540|144475871|SUPERIORITY||Mean Difference (Final Values)|10.112|STANDARD_ERROR_OF_MEAN|5.508||0.0863|TWO_SIDED|95.0|-1.629|21.853|||ANCOVA|||||21.853|-1.629|0.0863
72475398|NCT05116540|144475872|SUPERIORITY||Mean Difference (Final Values)|0.977|STANDARD_ERROR_OF_MEAN|1.633||0.5588|TWO_SIDED|95.0|-2.504|4.457|||ANCOVA|||||4.457|-2.504|0.5588
72507536|NCT00339183|144546656|SUPERIORITY_OR_OTHER_LEGACY||Normal score|-2.91||||0.0036|||||||Stratified log-rank test|P-value based on a 2-sided log-rank test stratified by ECOG (0 or 1 vs. 2), prior bevacizumab exposure, and prior oxaliplatin exposure (yes or no).|A normal score \<0 indicates fewer than expected events for the Panitumumab plus FOLFIRI arm and therefore a longer progression-free survival time.|An overall 5% significance level was used to compare treatments with respect to both overall survival (OS) and PFS. A 4% and 1% level (2-sided) was used to independently test OS and PFS, respectively.||||0.0036
72507537|NCT00339183|144546656|SUPERIORITY_OR_OTHER_LEGACY||Normal score|-1.46||||0.1448|||||||Stratified log-rank test|P-value based on a 2-sided log-rank test stratified by ECOG (0 or 1 vs. 2), prior bevacizumab exposure and prior oxaliplatin exposure (yes or no).|A normal score \<0 indicates fewer than expected events for the Panitumumab plus FOLFIRI arm and therefore a longer progression-free survival time.|PFS in the Mutant Efficacy Analysis Set was compared at a 1% level conditional upon first demonstrating a significant difference in PFS in the Wild-type KRAS Efficacy Analysis Set.||||0.1448
72566169|NCT01045993|144663004|SUPERIORITY_OR_OTHER|||||||0.219||95.0||||Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05.|ANOVA|P-value from ANOVA model with treatment term only in the model.||At Plus 5 degrees (beyond maximum)||||0.219
72566170|NCT01045993|144663005|SUPERIORITY_OR_OTHER|||||||0.043||95.0||||Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05.|ANOVA|P-value from ANOVA model with treatment term only in the model.||At Maximum degrees||||0.043
72475399|NCT05116540|144475873|SUPERIORITY||Mean Difference (Final Values)|-4.593|STANDARD_ERROR_OF_MEAN|1.023||0.0004|TWO_SIDED|95.0|-6.773|-2.413|||ANCOVA|||||-2.413|-6.773|0.0004
72475400|NCT01982448|144475954|SUPERIORITY||Odds Ratio (OR)|2.22|||||TWO_SIDED|95.0|0.39|23.68|||||Association between HRD status and pathologic response was measured by the odds ratio (OR).|In the Cisplatin treated patients, the relationship between HRD status and pathologic response was conducted by arm using a univariate logistic regression model and a likelihood ratio test with a one-sided type I error of alpha 0.05. Assuming 12.5% unevaluable, prevalence of HR deficiency 60%, 70 evaluable patients per in a given arm, there is \~80% power to detect a response rate of 52% in HR-deficient patients vs a 16% in HR non-deficient patients, corresponding to the Odds Ratio 5.7.||23.68|0.39|
72566171|NCT01045993|144663005|SUPERIORITY_OR_OTHER|||||||0.388||95.0||||Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05.|ANOVA|P-value from ANOVA model with treatment term only in the model.||At Minus 5 degrees||||0.388
72475401|NCT01982448|144475954|SUPERIORITY||Odds Ratio (OR)|0.9|||||TWO_SIDED|95.0|0.19|4.95||||||In the Paclitaxel treated patients, the relationship between HRD status and pathologic response was conducted by arm using a univariate logistic regression model and a likelihood ratio test with a one-sided type I error of alpha 0.05. Assuming 12.5% unevaluable, prevalence of HR deficiency 60%, 70 evaluable patients per in a given arm, there is \~80% power to detect a response rate of 37% in HR-deficient patients vs a 16% in HR non-deficient patients, corresponding to the Odds Ratio 0.62.||4.95|0.19|
72475402|NCT01982448|144475955|SUPERIORITY||Odds Ratio (OR)|2.32|||||TWO_SIDED|95.0|0.23|118.07||||||||118.07|0.23|
72566172|NCT01045993|144663005|SUPERIORITY_OR_OTHER|||||||0.039||95.0||||Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05.|ANOVA|P-value from ANOVA model with treatment term only in the model.||At Plus 5 degrees (beyond maximum)||||0.039
72398669|NCT03232281|144303989|NON_INFERIORITY|If the lower limit of the 95% CI for the difference was \>-10%, triptorelin pamoate PR 3-month non-inferiority to triptorelin acetate PR 1-month was observed without multiplicity adjustment.|Rate difference (%)|-2.7|||||TWO_SIDED|95.0|-7.44|1.17|||||The rate difference (triptorelin pamoate PR 3-month - triptorelin acetate PR 1-month) and the 2-sided 95% CI of the difference were calculated using the Miettinen and Nurminen method, stratified by randomisation stratification factors.|Rate difference at Week 12. The null hypothesis was that triptorelin pamoate PR 3-month was inferior to triptorelin acetate PR 1-month. The alternative hypothesis was that triptorelin pamoate PR 3-month was non-inferior to triptorelin acetate PR 1-month.||1.17|-7.44|
72398670|NCT00174915|144303996|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The overall 0.05 level of significance for the multiple comparisons of each febuxostat dose to placebo was controlled using Hochberg's method. The p-value was statistically significant.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL versus \[v.\] \>1.5 mg/dL).||||||<0.001
72398671|NCT00174915|144303996|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The overall 0.05 level of significance for the multiple comparisons of each febuxostat dose to placebo was controlled using Hochberg's method. The p-value was statistically significant.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL v. \>1.5 mg/dL).||||||<0.001
72398672|NCT00174915|144303996|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The overall 0.05 level of significance for the multiple comparisons of each febuxostat dose to placebo was controlled using Hochberg's method. The p-value was statistically significant.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL v. \>1.5 mg/dL).||||||<0.001
72398673|NCT00174915|144303996|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority of febuxostat 80 mg to allopurinol was declared if the value of the lower bound of the 97.5% confidence interval is \> -10%.|Difference in percentage|25.7||||||97.5|16.7|34.7||||||||34.7|16.7|
72475403|NCT01982448|144475955|SUPERIORITY||Odds Ratio (OR)|0.55|||||TWO_SIDED|95.0|0.09|4.14||||||||4.14|0.09|
72475404|NCT03333876|144475959|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Each group was compared to baseline.||||<.001
72475405|NCT00095498|144475964|SUPERIORITY_OR_OTHER_LEGACY|||||||0.264|||||||van Elteren stratified rank test|||||||0.264
72475406|NCT00095498|144475964|SUPERIORITY_OR_OTHER_LEGACY|||||||0.018|||||||van Elteren stratified rank test|||||||0.018
72566173|NCT01045993|144663006|SUPERIORITY_OR_OTHER|||||||0.797||95.0||||Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05.|ANOVA|P-value from ANOVA model with treatment term only in the model.||||||0.797
72566174|NCT01045993|144663007|SUPERIORITY_OR_OTHER|||||||0.371||95.0||||Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05.|ANOVA|P-value from ANOVA model with treatment term only in the model.||||||0.371
72566175|NCT01045993|144663008|SUPERIORITY_OR_OTHER|||||||0.122||95.0||||Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05.|ANOVA|P-value from ANOVA model with treatment term only in the model.||||||0.122
72475407|NCT00095498|144475965|SUPERIORITY_OR_OTHER_LEGACY|||||||0.032|||||||van Elteren Stratified Rank Test|||||||0.032
72475408|NCT00095498|144475965|SUPERIORITY_OR_OTHER_LEGACY|||||||0.18|||||||van Elteren Stratified Rank Test|||||||0.180
72475409|NCT00095498|144475966|SUPERIORITY_OR_OTHER_LEGACY|||||||0.602|||||||van Elteren Stratified Rank Test|||||||0.602
72475410|NCT00095498|144475966|SUPERIORITY_OR_OTHER_LEGACY|||||||0.181|||||||van Elteren Stratified Rank Test|||||||0.181
72475411|NCT00095498|144475967|SUPERIORITY_OR_OTHER_LEGACY|||||||0.012|||||||van Elteren Stratified Rank Test|||||||0.012
72475412|NCT00095498|144475967|SUPERIORITY_OR_OTHER_LEGACY|||||||0.007|||||||van Elteren Stratified Rank Test|||||||0.007
72475413|NCT00095498|144475968|SUPERIORITY_OR_OTHER_LEGACY|||||||0.277|||||||van Elteren Stratified Rank Test|||||||0.277
72475414|NCT00095498|144475968|SUPERIORITY_OR_OTHER_LEGACY|||||||0.019|||||||van Elteren Stratified Rank Test|||||||0.019
72475415|NCT00095498|144475969|SUPERIORITY_OR_OTHER_LEGACY|||||||0.382|||||||van Elteren Stratified Rank Test|||||||0.382
72475416|NCT00095498|144475969|SUPERIORITY_OR_OTHER_LEGACY|||||||0.488|||||||van Elteren Stratified Rank Test|||||||0.488
72475417|NCT00095498|144475970|SUPERIORITY_OR_OTHER_LEGACY|||||||0.236|||||||van Elteren Stratified Rank Test|||||||0.236
72475418|NCT00095498|144475970|SUPERIORITY_OR_OTHER_LEGACY|||||||0.712|||||||van Elteren Stratified Rank Test|||||||0.712
72475419|NCT00095498|144475971|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.93||||0.026||95.0|0.11|1.74|||Repeated Measures Model|||||1.74|0.11|0.026
72475420|NCT00095498|144475971|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.59||||0.155||95.0|-0.23|1.41|||Repeated measures model|||||1.41|-0.23|0.155
72566176|NCT01045993|144663009|SUPERIORITY_OR_OTHER|||||||0.355||95.0||||Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05.|ANOVA|P-value from ANOVA model with treatment term only in the model.||At Maximum degrees||||0.355
72566177|NCT01045993|144663009|SUPERIORITY_OR_OTHER|||||||0.371||95.0||||Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05.|ANOVA|P-value from ANOVA model with treatment term only in the model.||At Minus 5 degrees||||0.371
72475421|NCT00095498|144475972|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.67||||0.002||95.0|0.62|2.72|||Repeated Measures Model|||||2.72|0.62|0.002
72398674|NCT00174915|144303996|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority of febuxostat 120 mg to allopurinol was declared if the value of the lower bound of the 97.5% confidence interval is \> -10%.|Difference in percentage|42.7||||||97.5|34.0|51.3||||||||51.3|34.0|
72507538|NCT00339183|144546657|SUPERIORITY_OR_OTHER_LEGACY||Normal score|-1.57||||0.1154|||||||Stratified log-rank test|P-value based on a 2-sided log-rank test stratified by ECOG (0 or 1 vs. 2), prior bevacizumab exposure, and prior oxaliplatin exposure (yes or no).|A normal score \<0 indicates fewer than expected events for the Panitumumab plus FOLFIRI arm and therefore a longer overall survival time.|An overall 5% significance level was used to compare treatments with respect to both overall survival (OS) and PFS. A 4% and 1% level (2-sided) was used to independently test OS and PFS, respectively.||||0.1154
72507539|NCT00339183|144546657|SUPERIORITY_OR_OTHER_LEGACY||Normal score|-0.6||||0.5503|||||||Stratified log-rank test|P-value based on a 2-sided log-rank test stratified by ECOG (0 or 1 vs. 2), prior bevacizumab exposure, and prior oxaliplatin exposure (yes or no).|A normal score \<0 indicates fewer than expected events for the Panitumumab plus FOLFIRI arm and therefore a longer overall survival time.|The treatment effect on OS in the Mutant KRAS Efficacy Analysis Set was compared at the 4% level conditional on first demonstrating a significant OS treatment effect in the Wild-type KRAS Efficacy Analysis Set.||||0.5503
72507540|NCT00339183|144546658|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|5.33|||<|0.0001|TWO_SIDED|95.0|3.21|8.6|||Stratified exact test|Adjusted for ECOG score, prior bevacizumab exposure, prior oxaliplatin exposure.|The odds ratio is defined as the odds of having an objective response in the panitumumab plus arm relative to the odds on the FOLFIRI alone arm.|||8.60|3.21|<0.0001
72507541|NCT00339183|144546658|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.0||||1|TWO_SIDED|95.0|0.56|1.76|||Stratified exact test|Adjusted for ECOG score, prior bevacizumab exposure, prior oxaliplatin exposure.|The odds ratio is defined as the odds of having an objective response in the panitumumab plus arm relative to the odds on the FOLFIRI alone arm.|||1.76|0.56|1.0000
72398675|NCT00174915|144303996|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Comparisons of each febuxostat dose to allopurinol were adjusted to control the overall 0.05 level of significance for superiority by using Hochberg's method. The p-value was statistically significant.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL v. \>1.5 mg/dL).||||||<0.001
72475422|NCT00095498|144475972|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.89|||<|0.001||95.0|0.84|2.94|||Repeated Measures Model|||||2.94|0.84|<0.001
72475423|NCT00095498|144475973|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.2|||<|0.001||95.0|1.1|3.29|||Repeated Measures Model|||||3.29|1.1|<0.001
72475424|NCT00095498|144475973|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.29|||<|0.001||95.0|2.18|4.39|||Repeated Measures Model|||||4.39|2.18|<0.001
72475425|NCT00095498|144475974|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.01||||0.986||95.0|-1.06|1.08|||Repeated Measures Model|||||1.08|-1.06|0.986
72507542|NCT04392011|144546662|OTHER||AUC ratio (geometric mean)|1.39|||||TWO_SIDED|90.0|1.23|1.57||||||||1.57|1.23|
72507543|NCT04392011|144546663|OTHER||AUC ratio (geometric mean)|0.99|||||TWO_SIDED|90.0|0.83|1.19||||||||1.19|0.83|
72507544|NCT04392011|144546665|OTHER||Cmax ratio (midazolam)|1.5|||||TWO_SIDED|90.0|1.32|1.7||||||||1.70|1.32|
72507545|NCT04392011|144546665|OTHER||Cmax ratio (dextromethorphan)|0.96|||||TWO_SIDED|90.0|0.78|1.19||||||||1.19|0.78|
72507546|NCT04392011|144546667|OTHER||half-life ratio (dextromethorphan)|1.0|||||TWO_SIDED|90.0|0.92|1.08||||||||1.08|0.92|
72507547|NCT04392011|144546667|OTHER||half-life ratio (midazolam)|1.07|||||TWO_SIDED|90.0|0.98|1.17||||||||1.17|0.98|
72507548|NCT01455428|144546721|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.71|STANDARD_ERROR_OF_MEAN|0.188||0.0002|TWO_SIDED|95.0|-1.08|-0.34||Primary analysis was two-sided and performed at the 0.05 significance level.|ANCOVA|||Analysis performed using a general linear model with treatment and center as factors, and baseline value as a covariate.||-0.34|-1.08|0.0002
72507549|NCT01455428|144546722|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.49|STANDARD_ERROR_OF_MEAN|0.149||0.001|TWO_SIDED|95.0|-0.79|-0.2||All analyses were 2-sided and performed at the 0.05 significance level.|Mixed Model Repeated Measures Analysis|||Week 1 Modelled Results. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified.||-0.20|-0.79|0.0010
72507550|NCT01455428|144546722|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.65|STANDARD_ERROR_OF_MEAN|0.15|<|0.0001|TWO_SIDED|95.0|-0.94|-0.35||All analyses were 2-sided and performed at the 0.05 significance level.|Mixed Model Repeated Measures Analysis|||Week 2 Modelled Results. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified.||-0.35|-0.94|<0.0001
72507551|NCT01455428|144546722|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.58|STANDARD_ERROR_OF_MEAN|0.151||0.0001|TWO_SIDED|95.0|-0.88|-0.29||All analyses were 2-sided and performed at the 0.05 significance level.|Mixed Model Repeated Measures Analysis|||Week 3 Modelled Results. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified.||-0.29|-0.88|0.0001
72507552|NCT01455428|144546722|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.51|STANDARD_ERROR_OF_MEAN|0.152||0.0009|TWO_SIDED|95.0|-0.81|-0.21||All analyses were 2-sided and performed at the 0.05 significance level.|Mixed Model Repeated Measures Analysis|||Week 4 Modelled Results. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified.||-0.21|-0.81|0.0009
72507553|NCT01455428|144546722|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.51|STANDARD_ERROR_OF_MEAN|0.153||0.0009|TWO_SIDED|95.0|-0.81|-0.21||All analyses were 2-sided and performed at the 0.05 significance level.|Mixed Model Repeated Measures Analysis|||Week 5 Modelled Results. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified.||-0.21|-0.81|0.0009
72398676|NCT00174915|144303996|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Comparisons of each febuxostat dose to allopurinol were adjusted to control the overall 0.05 level of significance for superiority by using Hochberg's method. The p-value was statistically significant.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL v. \>1.5 mg/dL).||||||<0.001
72398677|NCT00174915|144303996|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL v. \>1.5 mg/dL).||||||<0.001
72398678|NCT00174915|144303996|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL v. \>1.5 mg/dL).||||||<0.001
72475426|NCT00095498|144475974|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.8||||0.141||95.0|-0.27|1.86|||Repeated Measures Model|||||1.86|-0.27|0.141
72475427|NCT00095498|144475975|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.95||||0.073||95.0|-0.09|1.99|||Repeated Measures Model|||||1.99|-0.09|0.073
72475428|NCT00095498|144475975|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.89||||0.09||95.0|-0.14|1.93|||Repeated Measures Model|||||1.93|-0.14|0.09
72566178|NCT01045993|144663009|SUPERIORITY_OR_OTHER|||||||0.216||95.0||||Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05.|ANOVA|P-values from ANOVA model with treatment treatment term only in the model.||At Plus 5 degrees (beyond maximum)||||0.216
72475429|NCT00095498|144475976|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.81||||0.007||95.0|0.51|3.12|||Repeated Measures Model|||||3.12|0.51|0.007
72475430|NCT00095498|144475976|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.98||||0.003||95.0|0.67|3.29|||Repeated Measures Model|||||3.29|0.67|0.003
72398679|NCT00174915|144303996|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL v. \>1.5 mg/dL).||||||<0.001
72398680|NCT00174915|144303996|SUPERIORITY_OR_OTHER|||||||0.479||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL v. \>1.5 mg/dL).||||||0.479
72398681|NCT00174915|144303996|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL v. \>1.5 mg/dL).||||||<0.001
72475431|NCT00095498|144475977|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.02||||0.938||95.0|-0.58|0.63|||Repeated Measures Model|||||0.63|-0.58|0.938
72475432|NCT00095498|144475977|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.08||||0.787||95.0|-0.53|0.69|||Repeated Measures Model|||||0.69|-0.53|0.787
72475433|NCT00095498|144475978|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.0||||0.004||95.0|0.33|1.67|||Repeated Measures Model|||||1.67|0.33|0.004
72475434|NCT00095498|144475978|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.18|||<|0.001||95.0|0.51|1.85|||Repeated Measures Model|||||1.85|0.51|<0.001
72475435|NCT00095498|144475979|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.94|||<|0.001||95.0|1.02|2.85|||Repeated Measures Model|||||2.85|1.02|<0.001
72475436|NCT00095498|144475979|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.04|||<|0.001||95.0|1.13|2.96|||Repeated Measures Model|||||2.96|1.13|<0.001
72475437|NCT00095498|144475980|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||van Elteren Stratified Rank Test|||||||<0.001
72475438|NCT00095498|144475980|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||van Elteren Stratified Rank Test|||||||<0.001
72475439|NCT00095498|144475981|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||van Elteren Stratified Rank Test|||||||<0.001
72475440|NCT00095498|144475981|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||van Elteren Stratified Rank Test|||||||<0.001
72475441|NCT00095498|144475982|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||van Elteren Stratified Rank Test|||||||<0.001
72475442|NCT00095498|144475982|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||van Elteren Stratified Rank Test|||||||<0.001
72475443|NCT00095498|144475983|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||van Elteren Stratified Rank Test|||||||<0.001
72475444|NCT00095498|144475983|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||van Elteren Stratified Rank Test|||||||<0.001
72475445|NCT00095498|144475984|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||van Elteren Stratified Rank Test|||||||<0.001
72475446|NCT00095498|144475984|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||van Elteren Stratified Rank Test|||||||<0.001
72475447|NCT00095498|144475985|SUPERIORITY_OR_OTHER_LEGACY|||||||0.016|||||||van Elteren Stratified Rank Test|||||||0.016
72475448|NCT00095498|144475985|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||van Elteren Stratified Rank Test|||||||<0.001
72475449|NCT00095498|144475986|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||van Elteren Stratified Rank Test|||||||<0.001
72475450|NCT00095498|144475986|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||van Elteren Stratified Rank Test|||||||<0.001
72475451|NCT00095498|144475987|SUPERIORITY_OR_OTHER_LEGACY|||||||0.673|||||||van Elteren Stratified Rank Test|||||||0.673
72475452|NCT00095498|144475987|SUPERIORITY_OR_OTHER_LEGACY|||||||0.589|||||||van Elteren Stratified Rank Test|||||||0.589
72475453|NCT00095498|144475988|SUPERIORITY_OR_OTHER_LEGACY|||||||0.175|||||||van Elteren Stratified Rank Test|||||||0.175
72475454|NCT00095498|144475988|SUPERIORITY_OR_OTHER_LEGACY|||||||0.133|||||||van Elteren Stratified Rank Test|||||||0.133
72475455|NCT03439254|144476117|OTHER||Response ratio(Mantel-Haenszel estimate)|1.13||||0.6172|TWO_SIDED|95.0|0.71|1.79|||Cochran-Mantel-Haenszel||Treatment / Placebo Response Ratio = Percentage of Responders in Active Treatment Arm / Percentage of Responders in Placebo, stratified by Baseline diabetes status (yes/no).|||1.79|0.71|0.6172
72398682|NCT00174915|144303997|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL v. \>1.5 mg/dL).||||||<0.001
72475456|NCT03439254|144476117|OTHER||Response ratio(Mantel-Haenszel estimate)|1.2||||0.4184|TWO_SIDED|95.0|0.77|1.89|||Cochran-Mantel-Haenszel||Treatment / Placebo Response Ratio = Percentage of Responders in Active Treatment Arm / Percentage of Responders in Placebo, stratified by Baseline diabetes status (yes/no).|||1.89|0.77|0.4184
72475457|NCT02075476|144476131|EQUIVALENCE|Normality in sample distribution was tested using the Kolmororov-Smirnov test and graphic models. For descriptive variables we use Pearson's Chi-square, and for the study of numerical variables over time we use a mixed linear test.||||||0.048|||||||Mixed Models Analysis|||||||0.048
72475458|NCT02075476|144476132|EQUIVALENCE|Normality in sample distribution was tested using the Kolmororov-Smirnov test and graphic models. For descriptive variables we use Pearson's Chi-square, and for the study of numerical variables over time we use a mixed linear test.||||||0.001|||||||Mixed Models Analysis|||||||0.001
72475459|NCT02075476|144476133|EQUIVALENCE|Normality in sample distribution was tested using the Kolmororov-Smirnov test and graphic models. For descriptive variables we use Pearson's Chi-square, and for the study of numerical variables over time we use a mixed linear test.||||||0.011|||||||Mixed Models Analysis|||||||0.011
72475460|NCT02898077|144476145|SUPERIORITY||Hazard Ratio (HR)|0.765||||0.0184|TWO_SIDED|95.0|0.613|0.955|||Log Rank|||||0.955|0.613|0.0184
72475461|NCT02898077|144476146|SUPERIORITY||Hazard Ratio (HR)|0.963|||||TWO_SIDED|95.0|0.771|1.203||||||||1.203|0.771|
72475462|NCT02898077|144476147|SUPERIORITY||Hazard Ratio (HR)|0.761|||||TWO_SIDED|95.0|0.598|0.968||||||||0.968|0.598|
72475463|NCT02898077|144476148|SUPERIORITY||Odds Ratio (OR)|0.8|||||TWO_SIDED|95.0|0.5|1.2||||||||1.2|0.5|
72475464|NCT02898077|144476149|SUPERIORITY||Hazard Ratio (HR)|0.905|||||TWO_SIDED|95.0|0.577|1.421||||||||1.421|0.577|
72475465|NCT00307684|144476216|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.89||||0.2586||95.0|-2.2055|7.9774||No adjustment for multiplicity was performed. threshold for significance: 0.05 (2-sided)|ANCOVA|treatment, sex and country as factors, age and baseline sum of inattention and hyperactivity/impulsivity scores as covariate||Based on preliminary results of a controlled study in adults with MPH, the mean (SD=9) change in CAARS total score from randomization to the 4 week post-randomization endpoint was estimated as +2.5 for PR OROS MPH and +14 for placebo. slightly more conservative, a mean change of 3 in the PR OROS MPH group and a mean increase of 10 in the placebo group were expected. With a two-sided type-I error of 5% and a power of 90%, 37 eligible subjects per group were required.||7.9774|-2.2055|0.2586
72475466|NCT00307684|144476219|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.3942||||0.2616||95.0|-12.1928|3.4044||No adjustment for multiplicity was performed.|ANCOVA|ANCOVA on the ranks with sex, treatment and country as factors and age and baseline score as a covariate||||3.4044|-12.1928|0.2616
72475467|NCT00307684|144476220|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.39||||0.5458||95.0|-5.5469|10.3213|||ANCOVA|treatment and country as factors baseline score as covariate||||10.3213|-5.5469|0.5458
72475468|NCT03377699|144476230|NON_INFERIORITY|Non-inferiority was considered confirmed if the upper bound of the two-sided 95% CI for mean treatment difference in HbA1c is strictly below 0.4%.|Mean treatment difference|-0.11|||<|0.0001|TWO_SIDED|95.0|-0.31|0.08|||ANCOVA|||Primary Estimand. Imputation of missing data was done within two groups of participants defined by randomised treatment arm based on a multiple imputation approach (x1000). For each of the 1000 imputed datasets last planned HbA1c prior to delivery after GW 16 was analysed using an ANCOVA with treatment, region and the stratification factor as categorical fixed effects and a pregnancy status at randomisation-by-baseline HbA1c interaction.||0.08|-0.31|<0.0001
72475469|NCT03377699|144476230|EQUIVALENCE|Non-inferiority was considered confirmed if the upper bound of the two-sided 95% CI for mean treatment difference in HbA1c is strictly below 0.4%.|Mean treatment difference|-0.08||||0.3881|TWO_SIDED|95.0|-0.27|0.11|||ANCOVA|||Secondary Estimand. Imputation of missing data was done within two groups of participants defined by randomised treatment arm based on a multiple imputation approach (x1000). For each of the 1000 imputed datasets last planned HbA1c prior to delivery after GW 16 was analysed using an ANCOVA with treatment, region and the stratification factor as categorical fixed effects and a pregnancy status at randomisation-by-baseline HbA1c interaction.||0.11|-0.27|0.3881
72475470|NCT02580305|144476254|SUPERIORITY|||||||0.41||||||Threshold for statistical significance was p≤0.05|Mixed Models Analysis|Statistical Method: Mixed model for repeated measures||||||0.41
72475471|NCT02580305|144476254|SUPERIORITY|||||||0.9||||||Threshold for statistical significance was p≤0.05|Mixed Models Analysis|Statistical Method: Mixed model for repeated measures||||||0.90
72475472|NCT02580305|144476255|SUPERIORITY|||||||0.46||||||Threshold for statistical significance was p≤0.05|Mixed Models Analysis|Statistical Method: Mixed model for repeated measures||||||0.46
72475473|NCT02580305|144476255|SUPERIORITY|||||||0.48||||||Threshold for statistical significance was p≤0.05|Mixed Models Analysis|Statistical Method: Mixed model for repeated measures||||||0.48
72475474|NCT02580305|144476256|SUPERIORITY|||||||0.83||||||Threshold for statistical significance was p≤0.05|Mixed Models Analysis|Statistical Method: Mixed model for repeated measures||||||0.83
72475475|NCT02580305|144476256|SUPERIORITY|||||||0.24||||||Threshold for statistical significance was p≤0.05|Mixed Models Analysis|Statistical Method: Mixed model for repeated measures||||||0.24
72475476|NCT02580305|144476257|SUPERIORITY|||||||0.17||||||Threshold for statistical significance was p≤0.05|Mixed Models Analysis|Statistical Method: Mixed model for repeated measures||||||0.17
72475477|NCT02580305|144476257|SUPERIORITY|||||||0.14||||||Threshold for statistical significance was p≤0.05|Mixed Models Analysis|Statistical Method: Mixed model for repeated measures||||||0.14
72475478|NCT02580305|144476258|SUPERIORITY|||||||0.79||||||Threshold for statistical significance was p≤0.05|Mixed Models Analysis|Statistical Method: Mixed model for repeated measures||||||0.79
72475479|NCT02580305|144476258|SUPERIORITY|||||||0.92||||||Threshold for statistical significance was p≤0.05|Mixed Models Analysis|Statistical Method: Mixed model for repeated measures||||||0.92
72475480|NCT01404429|144476272|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.14||||0.6|TWO_SIDED|95.0|-0.26|0.54|||t-test, 2 sided|||||0.54|-0.26|0.6
72398683|NCT00174915|144303997|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL v. \>1.5 mg/dL).||||||<0.001
72398684|NCT00174915|144303997|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL v. \>1.5 mg/dL).||||||<0.001
72398685|NCT00174915|144303997|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL v. \>1.5 mg/dL).||||||<0.001
72398686|NCT00174915|144303997|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL v. \>1.5 mg/dL).||||||<0.001
72398687|NCT00174915|144303997|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL v. \>1.5 mg/dL).||||||<0.001
72398688|NCT00174915|144303997|SUPERIORITY_OR_OTHER|||||||0.011||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL v. \>1.5 mg/dL).||||||0.011
72398689|NCT00174915|144303997|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL v. \>1.5 mg/dL).||||||<0.001
72475481|NCT01163292|144476295|SUPERIORITY_OR_OTHER|||||||0.144||95.0|||||Wilcoxon Rank Sum|||Week 0||||0.144
72398690|NCT00174915|144303997|SUPERIORITY_OR_OTHER|||||||0.091||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL v. \>1.5 mg/dL).||||||0.091
72398691|NCT00174915|144303997|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL v. \>1.5 mg/dL).||||||<0.001
72475482|NCT01163292|144476295|SUPERIORITY_OR_OTHER|||||||0.004||95.0|||||Wilcoxon Rank Sum|||Week 26||||0.004
72475483|NCT01163292|144476295|SUPERIORITY_OR_OTHER|||||||0.006||95.0|||||Wilcoxon Rank Sum|||Week 52||||0.006
72475484|NCT01163292|144476296|SUPERIORITY_OR_OTHER|||||||0.29||95.0|||||Fisher Exact|||Week 0||||0.290
72566179|NCT01045993|144663010|SUPERIORITY_OR_OTHER|||||||0.054||95.0||||Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05.|ANOVA|P-value from ANOVA model with treatment term only in the model.||At Maximum degrees||||0.054
72398692|NCT00174915|144303998|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL v. \>1.5 mg/dL).||||||<0.001
72398693|NCT00174915|144303998|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL v. \>1.5 mg/dL).||||||<0.001
72475485|NCT01163292|144476296|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|||Week 26||||1.000
72475486|NCT01163292|144476296|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||Fisher Exact|||Week 52||||0.001
72475487|NCT01163292|144476297|SUPERIORITY_OR_OTHER|||||||0.335||95.0|||||Wilcoxon Rank Sum|||||||0.335
72475488|NCT01163292|144476298|SUPERIORITY_OR_OTHER|||||||0.266||95.0|||||Wilcoxon Rank Sum|||Week 0||||0.266
72475489|NCT01163292|144476298|SUPERIORITY_OR_OTHER|||||||0.44||95.0|||||Wilcoxon Rank Sum|||Week 26||||0.440
72475490|NCT01163292|144476298|SUPERIORITY_OR_OTHER|||||||0.609||95.0|||||Wilcoxon Rank Sum|||Week 52||||0.609
72475491|NCT02217475|144476307|SUPERIORITY||Odds Ratio (OR)|0.816||||0.5194|TWO_SIDED|95.0|0.439|1.516|||Regression, Logistic|Logistic regression model was used for analysis. Randomized treatment group, NAS score at screening and fibrosis stage were the factors.||||1.516|0.439|0.5194
72475492|NCT02217475|144476308|SUPERIORITY||Odds Ratio (OR)|1.934||||0.0388|TWO_SIDED|95.0|1.035|3.614|||Regression, Logistic|Logistic regression model was used for analysis. Randomized treatment group, NAS score at screening and fibrosis stage were the factors.||||3.614|1.035|0.0388
72475493|NCT02217475|144476309|SUPERIORITY||Odds Ratio (OR)|1.249||||0.592|TWO_SIDED|95.0|0.553|2.821|||Regression, Logistic|Logistic regression model was used for analysis. Randomized treatment group, NAS score at screening and fibrosis stage were the factors.||||2.821|0.553|0.5920
72475494|NCT02217475|144476310|SUPERIORITY||Odds Ratio (OR)|1.396||||0.4941|TWO_SIDED|95.0|0.537|3.628|||Regression, Logistic|Logistic regression model was used for analysis. Randomized treatment group, NAS score at screening and fibrosis stage were the factors.||||3.628|0.537|0.4941
72475495|NCT02217475|144476311|SUPERIORITY||Odds Ratio (OR)|1.142||||0.8434|TWO_SIDED|95.0|0.305|4.277|||Regression, Logistic|Logistic regression model was used for analysis. Randomized treatment group, NAS score at screening and fibrosis stage were the factors.||||4.277|0.305|0.8434
72475496|NCT02217475|144476312|SUPERIORITY||Odds Ratio (OR)|2.201||||0.0234|TWO_SIDED|95.0|1.113|4.352|||Regression, Logistic|Logistic regression model was used for analysis. Randomized treatment group, NAS score at screening and fibrosis stage were the factors.||||4.352|1.113|0.0234
72475497|NCT02217475|144476313|SUPERIORITY||Odds Ratio (OR)|1.154||||0.7474|TWO_SIDED|95.0|0.484|2.752|||Regression, Logistic|Logistic regression model was used for analysis. Randomized treatment group, NAS score at screening and fibrosis stage were the factors.||||2.752|0.484|0.7474
72398694|NCT00174915|144303998|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL v. \>1.5 mg/dL).||||||<0.001
72398695|NCT00174915|144303998|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL v. \>1.5 mg/dL).||||||<0.001
72398696|NCT00174915|144303998|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL v. \>1.5 mg/dL).||||||<0.001
72398697|NCT00174915|144303998|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL v. \>1.5 mg/dL).||||||<0.001
72398698|NCT00174915|144303998|SUPERIORITY_OR_OTHER|||||||0.074||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL v. \>1.5 mg/dL).||||||0.074
72398699|NCT00174915|144303998|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL v. \>1.5 mg/dL).||||||<0.001
72398700|NCT00174915|144303998|SUPERIORITY_OR_OTHER|||||||0.001||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL v. \>1.5 mg/dL).||||||0.001
72398701|NCT00174915|144303998|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL v. \>1.5 mg/dL).||||||<0.001
72398702|NCT00174915|144303999|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values for pairwise comparisons are from contrast within the framework of the ANOVA model with treatment and baseline renal function as factors. Statistical significance was determined at the 0.05 level without adjustments for multiple comparisons.|ANOVA|||||||<0.001
72398703|NCT00174915|144303999|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values for pairwise comparisons are from contrast within the framework of the ANOVA model with treatment and baseline renal function as factors. Statistical significance was determined at the 0.05 level without adjustments for multiple comparisons.|ANOVA|||||||<0.001
72398704|NCT00174915|144303999|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values for pairwise comparisons are from contrast within the framework of the ANOVA model with treatment and baseline renal function as factors. Statistical significance was determined at the 0.05 level without adjustments for multiple comparisons.|ANOVA|||||||<0.001
72398705|NCT00174915|144303999|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values for pairwise comparisons are from contrast within the framework of the ANOVA model with treatment and baseline renal function as factors. Statistical significance was determined at the 0.05 level without adjustments for multiple comparisons.|ANOVA|||||||<0.001
72398706|NCT00174915|144303999|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values for pairwise comparisons are from contrast within the framework of the ANOVA model with treatment and baseline renal function as factors. Statistical significance was determined at the 0.05 level without adjustments for multiple comparisons.|ANOVA|||||||<0.001
72398707|NCT00174915|144303999|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values for pairwise comparisons are from contrast within the framework of the ANOVA model with treatment and baseline renal function as factors. Statistical significance was determined at the 0.05 level without adjustments for multiple comparisons.|ANOVA|||||||<0.001
72398708|NCT00174915|144303999|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values for pairwise comparisons are from contrast within the framework of the ANOVA model with treatment and baseline renal function as factors. Statistical significance was determined at the 0.05 level without adjustments for multiple comparisons.|ANOVA|||||||<0.001
72398709|NCT00174915|144303999|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values for pairwise comparisons are from contrast within the framework of the ANOVA model with treatment and baseline renal function as factors. Statistical significance was determined at the 0.05 level without adjustments for multiple comparisons.|ANOVA|||||||<0.001
72398710|NCT00174915|144303999|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values for pairwise comparisons are from contrast within the framework of the ANOVA model with treatment and baseline renal function as factors. Statistical significance was determined at the 0.05 level without adjustments for multiple comparisons.|ANOVA|||||||<0.001
72475498|NCT02643472|144476359|SUPERIORITY|||||||0.73|||||||Generalized Estimating Equations|In analyzing predicted means, results of Generalized Estimating Equations (GEE) modeling controlled for time from baseline at each assessment.||||||0.73
72475499|NCT02643472|144476360|SUPERIORITY|||||||0.12|||||||Generalized Estimating Equations|In analyzing predicted means, results of Generalized Estimating Equations (GEE) modeling controlled for time from baseline at each assessment.||STAI Y-1 data was used in these statistical analyses.||||0.12
72475500|NCT02643472|144476361|SUPERIORITY|||||||0.03|||||||Generalized Estimating Equations|In analyzing predicted means, results of Generalized Estimating Equations (GEE) modeling controlled for time from baseline at each assessment.||||||0.03
72475501|NCT02643472|144476364|SUPERIORITY|||||||0.06|||||||Generalized Estimating Equations|In analyzing predicted means, results of Generalized Estimating Equations (GEE) modeling controlled for time from baseline at each assessment.||||||0.06
72475502|NCT02643472|144476365|SUPERIORITY|||||||0.43|||||||Wilcoxon (Mann-Whitney)|||||||0.43
72475503|NCT02643472|144476366|SUPERIORITY|||||||0.64|||||||Wilcoxon (Mann-Whitney)|||||||0.64
72475504|NCT02643472|144476367|SUPERIORITY|||||||0.6|||||||Chi-squared|||||||0.60
72475505|NCT02643472|144476368|SUPERIORITY|||||||0.92|||||||t-test, 2 sided|||Infant development status was evaluated with Bayley subscales. Cognitive subscale.||||0.92
72398711|NCT00174915|144303999|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values for pairwise comparisons are from contrast within the framework of the ANOVA model with treatment and baseline renal function as factors. Statistical significance was determined at the 0.05 level without adjustments for multiple comparisons.|ANOVA|||||||<0.001
72398712|NCT00174915|144304000|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values for pairwise comparisons are from contrast within the framework of the ANOVA model with treatment and baseline renal function as factors. Statistical significance was determined at the 0.05 level without adjustments for multiple comparisons.|ANOVA|||||||<0.001
72398713|NCT00174915|144304000|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values for pairwise comparisons are from contrast within the framework of the ANOVA model with treatment and baseline renal function as factors. Statistical significance was determined at the 0.05 level without adjustments for multiple comparisons.|ANOVA|||||||<0.001
72398714|NCT00174915|144304000|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values for pairwise comparisons are from contrast within the framework of the ANOVA model with treatment and baseline renal function as factors. Statistical significance was determined at the 0.05 level without adjustments for multiple comparisons.|ANOVA|||||||<0.001
72566180|NCT01045993|144663010|SUPERIORITY_OR_OTHER|||||||0.6||95.0||||Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05.|ANOVA|P-value from ANOVA model with treatment term only in the model.||At Minus 5 degrees||||0.600
72566181|NCT01045993|144663010|SUPERIORITY_OR_OTHER|||||||0.294||95.0||||Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05.|ANOVA|P-value from ANOVA model with treatment term only in the model.||At Plus 5 degrees (beyond maximum)||||0.294
72398715|NCT00174915|144304000|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values for pairwise comparisons are from contrast within the framework of the ANOVA model with treatment and baseline renal function as factors. Statistical significance was determined at the 0.05 level without adjustments for multiple comparisons.|ANOVA|||||||<0.001
72398716|NCT00174915|144304000|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values for pairwise comparisons are from contrast within the framework of the ANOVA model with treatment and baseline renal function as factors. Statistical significance was determined at the 0.05 level without adjustments for multiple comparisons.|ANOVA|||||||<0.001
72398717|NCT00174915|144304000|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values for pairwise comparisons are from contrast within the framework of the ANOVA model with treatment and baseline renal function as factors. Statistical significance was determined at the 0.05 level without adjustments for multiple comparisons.|ANOVA|||||||<0.001
72475506|NCT02643472|144476368|SUPERIORITY|||||||0.58|||||||t-test, 2 sided|||Infant development status was evaluated with Bayley subscales. Language subscale.||||0.58
72475507|NCT02643472|144476368|SUPERIORITY|||||||0.87|||||||t-test, 2 sided|||Infant development status was evaluated with Bayley subscales. Motor subscale.||||0.87
72475508|NCT00673400|144476398|SUPERIORITY_OR_OTHER|||||||0.134||95.0||||based on 28 pairwise matches|Wilcoxon (Mann-Whitney)|matched pair test, two-sided, exact method||Lifestyle (LS)||||0.1340
72475509|NCT00673400|144476398|SUPERIORITY_OR_OTHER|||||||0.088||95.0||||based on 29 matched pairs|Wilcoxon (Mann-Whitney)|matched pair test, two-sided, exact method||Coping/behavior (C/B)||||0.088
72475510|NCT00673400|144476398|SUPERIORITY_OR_OTHER|||||||0.0012||95.0||||based on 30 matched pairs|Wilcoxon (Mann-Whitney)|matched pair test, two-sided, exact method||Depression/self-perception (D/S)||||0.0012
72475511|NCT00673400|144476398|SUPERIORITY_OR_OTHER|||||||0.0074||95.0||||based on 30 matched pairs|Wilcoxon (Mann-Whitney)|matched pair test, two-sided, exact method||Embarrassment (E)||||0.0074
72475512|NCT00673400|144476401|SUPERIORITY_OR_OTHER||||||<|1e-07||95.0|||||Wilcoxon (Mann-Whitney)|two-sided, paired test, exact method||||||<0.0000001
72475513|NCT00673400|144476401|SUPERIORITY_OR_OTHER||||||<|1e-07||95.0|||||Wilcoxon (Mann-Whitney)|two-sided, paired test, exact method||||||<0.0000001
72475514|NCT00673400|144476401|SUPERIORITY_OR_OTHER||||||<|1e-07||95.0|||||Wilcoxon (Mann-Whitney)|two-sided, paired test, exact method||||||<0.0000001
72475515|NCT00673400|144476402|SUPERIORITY_OR_OTHER||||||<|1e-07||95.0|||||Wilcoxon (Mann-Whitney)|two-sided, paired test, exact method||||||<0.0000001
72475516|NCT00673400|144476402|SUPERIORITY_OR_OTHER||||||<|1e-07||95.0|||||Wilcoxon (Mann-Whitney)|two-sided, paired test, exact method||||||<0.0000001
72475517|NCT00673400|144476402|SUPERIORITY_OR_OTHER||||||<|1e-07||95.0|||||Wilcoxon (Mann-Whitney)|two-sided, paired test, exact method||||||<0.0000001
72475518|NCT00673400|144476403|SUPERIORITY_OR_OTHER|||||||0.65||95.0||||based on 28 pairwise matches|Wilcoxon (Mann-Whitney)|matched pair test, two-sided, exact method||Physical component summary (PCS)||||0.65
72475519|NCT00673400|144476403|SUPERIORITY_OR_OTHER|||||||0.01||95.0||||based on 28 pairwise matches|Wilcoxon (Mann-Whitney)|matched pair test, two-sided, exact method||Mental component summary (MCS)||||0.010
72475520|NCT00291642|144476413|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.35|STANDARD_ERROR_OF_MEAN|0.64|<|0.001|TWO_SIDED|95.0|-4.61|-2.09|||ANCOVA|||||-2.09|-4.61|<0.001
72475521|NCT00291642|144476413|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.25|STANDARD_ERROR_OF_MEAN|0.637|<|0.001|TWO_SIDED|95.0|-4.5|-2.0|||ANCOVA|||||-2.00|-4.50|<0.001
72475522|NCT00291642|144476413|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.13|STANDARD_ERROR_OF_MEAN|0.637|<|0.001|TWO_SIDED|95.0|-5.38|-2.88|||ANCOVA|||||-2.88|-5.38|<0.001
72475523|NCT00291642|144476413|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.74|STANDARD_ERROR_OF_MEAN|0.637|<|0.001|TWO_SIDED|95.0|-4.99|-2.49|||ANCOVA|||||-2.49|-4.99|<0.001
72475524|NCT02576587|144476427|OTHER|Conditional logistic regression was used to assess the relationship of PAF and AHI on matched pairs of case and control.|Odds Ratio (OR)|0.98|STANDARD_ERROR_OF_MEAN|0.007||0.054|TWO_SIDED|95.0|0.97|1.0|||Conditional logistic regression|||||1.00|0.97|0.054
72475525|NCT02576587|144476427|OTHER|Conditional logistic regression was used to assess the relationship of PAF and LA volume on matched pairs of case and control.|Odds Ratio (OR)|1.02|STANDARD_ERROR_OF_MEAN|0.007||0.014|TWO_SIDED|95.0|1.0|1.03|||Conditional logistic regression|N = 270 (135 cases and 135 controls)||||1.03|1.00|0.014
72398718|NCT00174915|144304000|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values for pairwise comparisons are from contrast within the framework of the ANOVA model with treatment and baseline renal function as factors. Statistical significance was determined at the 0.05 level without adjustments for multiple comparisons.|ANOVA|||||||<0.001
72398719|NCT00174915|144304000|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values for pairwise comparisons are from contrast within the framework of the ANOVA model with treatment and baseline renal function as factors. Statistical significance was determined at the 0.05 level without adjustments for multiple comparisons.|ANOVA|||||||<0.001
72398720|NCT00174915|144304000|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values for pairwise comparisons are from contrast within the framework of the ANOVA model with treatment and baseline renal function as factors. Statistical significance was determined at the 0.05 level without adjustments for multiple comparisons.|ANOVA|||||||<0.001
72398721|NCT00174915|144304000|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values for pairwise comparisons are from contrast within the framework of the ANOVA model with treatment and baseline renal function as factors. Statistical significance was determined at the 0.05 level without adjustments for multiple comparisons.|ANOVA|||||||<0.001
72398722|NCT00174915|144304001|SUPERIORITY_OR_OTHER|||||||0.789||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.789
72398723|NCT00174915|144304001|SUPERIORITY_OR_OTHER|||||||0.32||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.320
72398724|NCT00174915|144304001|SUPERIORITY_OR_OTHER|||||||0.381||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.381
72507554|NCT01455428|144546722|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.59|STANDARD_ERROR_OF_MEAN|0.153||0.0001|TWO_SIDED|95.0|-0.89|-0.29||All analyses were 2-sided and performed at the 0.05 significance level.|Mixed Model Repeated Measures Analysis|||Week 6 Modelled Results. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified.||-0.29|-0.89|0.0001
72507555|NCT01455428|144546722|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.71|STANDARD_ERROR_OF_MEAN|0.154|<|0.0001|TWO_SIDED|95.0|-1.01|-0.41||All analyses were 2-sided and performed at the 0.05 significance level.|Mixed Model Repeated Measures Analysis|||Week 7 Modelled Results. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified.||-0.41|-1.01|<0.0001
72398725|NCT00174915|144304001|SUPERIORITY_OR_OTHER|||||||0.809||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.809
72398726|NCT00174915|144304001|SUPERIORITY_OR_OTHER|||||||0.154||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.154
72398727|NCT00174915|144304001|SUPERIORITY_OR_OTHER|||||||0.247||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.247
72398728|NCT00174915|144304001|SUPERIORITY_OR_OTHER|||||||0.415||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.415
72566182|NCT01045993|144663011|SUPERIORITY_OR_OTHER|||||||0.088||95.0||||Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05.|ANOVA|P-value from ANOVA model with treatment term only in the model.||At Maximum degrees||||0.088
72398729|NCT00174915|144304001|SUPERIORITY_OR_OTHER|||||||0.649||95.0||||Statistical significance was determined at the 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.649
72398730|NCT00174915|144304001|SUPERIORITY_OR_OTHER|||||||0.807||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.807
72398731|NCT00174915|144304001|SUPERIORITY_OR_OTHER|||||||0.844||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.844
72398732|NCT00174915|144304002|SUPERIORITY_OR_OTHER|||||||0.699||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.699
72398733|NCT00174915|144304002|SUPERIORITY_OR_OTHER|||||||0.822||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.822
72398734|NCT00174915|144304002|SUPERIORITY_OR_OTHER|||||||0.579||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.579
72398735|NCT00174915|144304002|SUPERIORITY_OR_OTHER|||||||0.679||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.679
72398736|NCT00174915|144304002|SUPERIORITY_OR_OTHER|||||||0.278||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.278
72398737|NCT00174915|144304002|SUPERIORITY_OR_OTHER|||||||0.104||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.104
72398738|NCT00174915|144304002|SUPERIORITY_OR_OTHER|||||||0.56||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.560
72398739|NCT00174915|144304002|SUPERIORITY_OR_OTHER|||||||0.309||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.309
72398740|NCT00174915|144304002|SUPERIORITY_OR_OTHER|||||||0.759||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.759
72398741|NCT00174915|144304002|SUPERIORITY_OR_OTHER|||||||0.385||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.385
72566183|NCT01045993|144663011|SUPERIORITY_OR_OTHER|||||||0.625||95.0||||Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05.|ANOVA|P-value from ANOVA model with treatment term only in the model.||At Minus 5 degrees||||0.625
72566184|NCT01045993|144663011|SUPERIORITY_OR_OTHER|||||||0.034||95.0||||Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05.|ANOVA|P-value from ANOVA model with treatment term only in the model.||At Plus 5 degrees (beyond maximum)||||0.034
72566185|NCT01045993|144663012|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05.|Cochran-Mantel-Haenszel|P-value from the Cochran-Mantel-Haenszel test with modified ridit scores.||||||<0.001
72566186|NCT00484419|144663045|SUPERIORITY_OR_OTHER|||||||0.0061||95.0|||||t-test, 2 sided|||For a treatment group, assuming a within-subject standard deviation of at most 1.15, a 2-sided t-test of the null hypothesis that the change from baseline (CFB) is zero will have 67% to 85% power to detect a difference of 0.4 to 0.5 with a sample size of 50 randomized subjects.||||0.0061
72566187|NCT00484419|144663045|SUPERIORITY_OR_OTHER|||||||0.109||95.0|||||t-test, 2 sided|||For a treatment group, assuming a within-subject standard deviation of at most 1.15, a 2-sided t-test of the null hypothesis that the change from baseline (CFB) is zero will have 67% to 85% power to detect a difference of 0.4 to 0.5 with a sample size of 50 randomized subjects.||||0.1090
72566188|NCT00484419|144663045|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||For a treatment group, assuming a within-subject standard deviation of at most 1.15, a 2-sided t-test of the null hypothesis that the change from baseline (CFB) is zero will have 67% to 85% power to detect a difference of 0.4 to 0.5 with a sample size of 50 randomized subjects.||||<0.0001
72566189|NCT00484419|144663046|SUPERIORITY_OR_OTHER|||||||0.0234||95.0|||||t-test, 2 sided|||For a treatment group, assuming a within-subject standard deviation of at most 1.15, a 2-sided t-test of the null hypothesis that the change from baseline (CFB) is zero will have 67% to 85% power to detect a difference of 0.4 to 0.5 with a sample size of 50 randomized subjects.||||0.0234
72566190|NCT00484419|144663046|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||For a treatment group, assuming a within-subject standard deviation of at most 1.15, a 2-sided t-test of the null hypothesis that the change from baseline (CFB) is zero will have 67% to 85% power to detect a difference of 0.4 to 0.5 with a sample size of 50 randomized subjects.||||<0.0001
72566191|NCT00484419|144663046|SUPERIORITY_OR_OTHER|||||||0.0011||95.0|||||t-test, 2 sided|||For a treatment group, assuming a within-subject standard deviation of at most 1.15, a 2-sided t-test of the null hypothesis that the change from baseline (CFB) is zero will have 67% to 85% power to detect a difference of 0.4 to 0.5 with a sample size of 50 randomized subjects.||||0.0011
72507556|NCT01455428|144546722|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.154|<|0.0001|TWO_SIDED|95.0|-1.0|-0.4||All analyses were 2-sided and performed at the 0.05 significance level.|Mixed Model Repeated Measures Analysis|||Week 8 Modelled Results. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified.||-0.40|-1.00|<0.0001
72566192|NCT00484419|144663049|SUPERIORITY_OR_OTHER|||||||0.0077||95.0|||||t-test, 2 sided|||P-value presents results from 1-sample t-test for within-treatment difference from baseline.||||0.0077
72566193|NCT00484419|144663049|SUPERIORITY_OR_OTHER|||||||0.0004||95.0|||||t-test, 2 sided|||P-value presents results from 1-sample t-test for within-treatment difference from baseline.||||0.0004
72398742|NCT00174915|144304003|SUPERIORITY_OR_OTHER|||||||0.949||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.949
72398743|NCT00174915|144304003|SUPERIORITY_OR_OTHER|||||||0.05||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.050
72398744|NCT00174915|144304003|SUPERIORITY_OR_OTHER|||||||0.577||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.577
72398745|NCT00174915|144304003|SUPERIORITY_OR_OTHER|||||||0.598||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.598
72398746|NCT00174915|144304003|SUPERIORITY_OR_OTHER|||||||0.062||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.062
72398747|NCT00174915|144304003|SUPERIORITY_OR_OTHER|||||||0.969||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.969
72566194|NCT00484419|144663049|SUPERIORITY_OR_OTHER|||||||0.0483||95.0|||||t-test, 2 sided|||P-value presents results from 1-sample t-test for within-treatment difference from baseline.||||0.0483
72566195|NCT00484419|144663050|SUPERIORITY_OR_OTHER|||||||0.0133||95.0|||||t-test, 2 sided|||P-value presents results from 1-sample t-test for within-treatment difference from baseline.||||0.0133
72566196|NCT00484419|144663050|SUPERIORITY_OR_OTHER|||||||0.0004||95.0|||||t-test, 2 sided|||P-value presents results from 1-sample t-test for within-treatment difference from baseline.||||0.0004
72566197|NCT00484419|144663050|SUPERIORITY_OR_OTHER|||||||0.0125||95.0|||||t-test, 2 sided|||P-value presents results from 1-sample t-test for within-treatment difference from baseline.||||0.0125
72566198|NCT00484419|144663053|SUPERIORITY_OR_OTHER|||||||0.8596||95.0|||||t-test, 2 sided|||P-value presents results from 1-sample t-test for within-treatment difference from baseline.||||0.8596
72566199|NCT00484419|144663053|SUPERIORITY_OR_OTHER|||||||0.0257||95.0|||||t-test, 2 sided|||P-value presents results from 1-sample t-test for within-treatment difference from baseline.||||0.0257
72398748|NCT00174915|144304003|SUPERIORITY_OR_OTHER|||||||0.056||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.056
72398749|NCT00174915|144304003|SUPERIORITY_OR_OTHER|||||||0.659||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.659
72398750|NCT00174915|144304003|SUPERIORITY_OR_OTHER|||||||0.197||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.197
72398751|NCT00174915|144304003|SUPERIORITY_OR_OTHER|||||||0.521||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.521
72398752|NCT00174915|144304004|SUPERIORITY_OR_OTHER|||||||0.683||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.683
72398753|NCT00174915|144304004|SUPERIORITY_OR_OTHER|||||||0.078||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.078
72566200|NCT00484419|144663053|SUPERIORITY_OR_OTHER|||||||0.1862||95.0|||||t-test, 2 sided|||P-value presents results from 1-sample t-test for within-treatment difference from baseline.||||0.1862
72507557|NCT01455428|144546724|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.54|STANDARD_ERROR_OF_MEAN|0.2||0.0079|TWO_SIDED|95.0|-0.93|-0.14||Analysis was two-sided and performed at the 0.05 significance level.|ANCOVA|||Analysis performed using a general linear model with treatment and center as factors, and baseline value as a covariate.||-0.14|-0.93|0.0079
72507558|NCT01455428|144546725|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.52|STANDARD_ERROR_OF_MEAN|0.172||0.0024|TWO_SIDED|95.0|-0.86|-0.19||Analysis was two-sided and performed at the 0.05 significance level.|Mixed Model Repeated Measures Analysis|||Week 1 Modelled Results. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified.||-0.19|-0.86|0.0024
72507559|NCT01455428|144546725|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.65|STANDARD_ERROR_OF_MEAN|0.173||0.0002|TWO_SIDED|95.0|-0.99|-0.31||Analysis was two-sided and performed at the 0.05 significance level.|Mixed Model Repeated Measures Analysis|||Week 2 Modelled Results. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified.||-0.31|-0.99|0.0002
72507560|NCT01455428|144546725|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.57|STANDARD_ERROR_OF_MEAN|0.173||0.0012|TWO_SIDED|95.0|-0.91|-0.22||Analysis was two-sided and performed at the 0.05 significance level.|Mixed Model Repeated Measures Analysis|||Week 3 Modelled Results. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified.||-0.22|-0.91|0.0012
72566201|NCT00484419|144663054|SUPERIORITY_OR_OTHER|||||||0.7094||95.0|||||t-test, 2 sided|||P-value presents results from 1-sample t-test for within-treatment difference from baseline.||||0.7094
72566202|NCT00484419|144663054|SUPERIORITY_OR_OTHER|||||||0.1394||95.0|||||t-test, 2 sided|||P-value presents results from 1-sample t-test for within-treatment difference from baseline.||||0.1394
72566203|NCT00484419|144663054|SUPERIORITY_OR_OTHER|||||||0.4528||95.0|||||t-test, 2 sided|||P-value presents results from 1-sample t-test for within-treatment difference from baseline.||||0.4528
72398754|NCT00174915|144304004|SUPERIORITY_OR_OTHER|||||||0.442||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.442
72398755|NCT00174915|144304004|SUPERIORITY_OR_OTHER|||||||0.99||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.990
72398756|NCT00174915|144304004|SUPERIORITY_OR_OTHER|||||||0.077||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.077
72398757|NCT00174915|144304004|SUPERIORITY_OR_OTHER|||||||0.662||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.662
72398758|NCT00174915|144304004|SUPERIORITY_OR_OTHER|||||||0.139||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.139
72398759|NCT00174915|144304004|SUPERIORITY_OR_OTHER|||||||0.705||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.705
72398760|NCT00174915|144304004|SUPERIORITY_OR_OTHER|||||||0.337||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.337
72398761|NCT00174915|144304004|SUPERIORITY_OR_OTHER|||||||0.643||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.643
72566204|NCT00484419|144663056|SUPERIORITY_OR_OTHER|||||||0.0374||95.0|||||t-test, 2 sided|||P-value presents results from 1-sample t-test for within-treatment difference from baseline.||||0.0374
72566205|NCT00484419|144663056|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||P-value presents results from 1-sample t-test for within-treatment difference from baseline.||||<0.0001
72566206|NCT00484419|144663056|SUPERIORITY_OR_OTHER|||||||0.0001||95.0|||||t-test, 2 sided|||P-value presents results from 1-sample t-test for within-treatment difference from baseline.||||0.0001
72398762|NCT00174915|144304005|SUPERIORITY_OR_OTHER|||||||0.645||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL v. \>1.5 mg/dL).||||||0.645
72398763|NCT00174915|144304005|SUPERIORITY_OR_OTHER|||||||0.756||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL v. \>1.5 mg/dL).||||||0.756
72398764|NCT00174915|144304005|SUPERIORITY_OR_OTHER|||||||0.428||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL v. \>1.5 mg/dL).||||||0.428
72398765|NCT00174915|144304005|SUPERIORITY_OR_OTHER|||||||0.076||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons..|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL v. \>1.5 mg/dL)||||||0.076
72398766|NCT00174915|144304005|SUPERIORITY_OR_OTHER|||||||0.106||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL v. \>1.5 mg/dL).||||||0.106
72398767|NCT00174915|144304005|SUPERIORITY_OR_OTHER|||||||0.069||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL v. \>1.5 mg/dL).||||||0.069
72398768|NCT00174915|144304005|SUPERIORITY_OR_OTHER|||||||0.837||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL v. \>1.5 mg/dL).||||||0.837
72398769|NCT00174915|144304005|SUPERIORITY_OR_OTHER|||||||0.749||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL v. \>1.5 mg/dL).||||||0.749
72398770|NCT00174915|144304005|SUPERIORITY_OR_OTHER|||||||0.581||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL v. \>1.5 mg/dL).||||||0.581
72398771|NCT00174915|144304005|SUPERIORITY_OR_OTHER|||||||0.311||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL v. \>1.5 mg/dL).||||||0.311
72507561|NCT01455428|144546725|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.45|STANDARD_ERROR_OF_MEAN|0.174||0.0101|TWO_SIDED|95.0|-0.79|-0.11||Analysis was two-sided and performed at the 0.05 significance level.|Mixed Model Repeated Measures Analysis|||Week 4 Modelled Results. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified.||-0.11|-0.79|0.0101
72507562|NCT01455428|144546725|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.39|STANDARD_ERROR_OF_MEAN|0.175||0.0258|TWO_SIDED|95.0|-0.73|-0.05||Analysis was two-sided and performed at the 0.05 significance level.|Mixed Model Repeated Measures Analysis|||Week 5 Modelled Results. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified.||-0.05|-0.73|0.0258
72507563|NCT01455428|144546725|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.39|STANDARD_ERROR_OF_MEAN|0.175||0.026|TWO_SIDED|95.0|-0.74|-0.05||Analysis was two-sided and performed at the 0.05 significance level.|Mixed Model Repeated Measures Analysis|||Week 6 Modelled Results. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified.||-0.05|-0.74|0.0260
72566207|NCT00484419|144663057|SUPERIORITY_OR_OTHER|||||||0.2701||95.0|||||t-test, 2 sided|||P-value presents results from 1-sample t-test for within-treatment difference from baseline.||||0.2701
72398772|NCT00183092|144304006|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.43||||0.43|TWO_SIDED|95.0|0.58|3.53|||Regression, Cox|||||3.53|0.58|0.43
72398773|NCT00183092|144304007|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.5||||0.54||95.0||||Threshold for statistical significance = 0.05. One subject in the placebo group was administered only 25 items on the MMSE due to visual impairment, and this subject's score was scaled based on percentage correct.|ANCOVA|||The difference between change scores, adjusted for Month-0 performance. Positive adjusted differences indicate greater adjusted change (worsening) in the placebo group; negative indicate greater adjusted changed (worsening) in the quinacrine group.||||.54
72398774|NCT00183092|144304008|SUPERIORITY_OR_OTHER||Mean Difference (Net)|7.9||||0.36||95.0||||significance threshold p=0.05|Quade's rank analysis of covariance|||The difference between scores, adjusted for Month-0 performance.||||.36
72398775|NCT00183092|144304009|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.8||||0.01||95.0||||Significance threshold p\<0.05|Quade's rank analysis of covariance|||The difference between change scores, adjusted for Month-0 performance. Positive adjusted differences indicate greater adjusted change (worsening) in the placebo group; negative indicate greater adjusted changed (worsening) in the quinacrine group.||||.01
72398776|NCT00183092|144304010|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.5||||0.03||95.0||||Threshold for significance p\<0.05|Quade's rank analysis of covariance|||The difference between change scores, adjusted for Month-0 performance. Positive adjusted differences indicate greater adjusted change (worsening) in the placebo group; negative indicate greater adjusted changed (worsening) in the quinacrine group.||||0.03
72398777|NCT00183092|144304011|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.7||||0.92||95.0||||Significance threshold p\<0.05|ANCOVA|||The difference between change scores, adjusted for Month-0 performance. Positive adjusted differences indicate greater adjusted change (worsening) in the placebo group; negative indicate greater adjusted changed (worsening) in the quinacrine group.||||0.92
72507564|NCT01455428|144546725|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.48|STANDARD_ERROR_OF_MEAN|0.175||0.0062|TWO_SIDED|95.0|-0.83|-0.14||Analysis was two-sided and performed at the 0.05 significance level.|Mixed Model Repeated Measures Analysis|||Week 7 Modelled Results. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified.||-0.14|-0.83|0.0062
72507565|NCT01455428|144546725|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.47|STANDARD_ERROR_OF_MEAN|0.176||0.0081|TWO_SIDED|95.0|-0.81|-0.12||Analysis was two-sided and performed at the 0.05 significance level.|Mixed Model Repeated Measures Analysis|||Week 8 Modelled Results. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified.||-0.12|-0.81|0.0081
72566208|NCT00484419|144663057|SUPERIORITY_OR_OTHER|||||||0.6117||95.0|||||t-test, 2 sided|||P-value presents results from 1-sample t-test for within-treatment difference from baseline.||||0.6117
72566209|NCT00484419|144663057|SUPERIORITY_OR_OTHER|||||||0.2007||95.0|||||t-test, 2 sided|||P-value presents results from 1-sample t-test for within-treatment difference from baseline.||||0.2007
72398778|NCT00183092|144304012|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.4||||0.71||95.0||||Significance threshold p\<0.05|ANCOVA|||The difference between change scores, adjusted for Month-0 performance. Positive adjusted differences indicate greater adjusted change (worsening) in the placebo group; negative indicate greater adjusted changed (worsening) in the quinacrine group.||||0.71
72507566|NCT01455428|144546726|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0007||||||Analysis was two-sided and performed at the 0.05 significance level|Cochran-Mantel-Haenszel|||Cochran-Mantel-Haenszel test comparing pregabalin to placebo adjusted for center.||||0.0007
72507567|NCT01455428|144546729|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-8.18|STANDARD_ERROR_OF_MEAN|1.932|<|0.0001|TWO_SIDED|95.0|-11.99|-4.37||Analysis was two-sided and performed at the 0.05 significance level.|ANCOVA|||Analysis performed using a general linear model with treatment and center as factors, and baseline value as a covariate.||-4.37|-11.99|<0.0001
72507568|NCT01455428|144546730|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.37|STANDARD_ERROR_OF_MEAN|0.107||0.0007|TWO_SIDED|95.0|-0.58|-0.16||Analysis was two-sided and performed at the 0.05 significance level.|ANCOVA|||Analysis performed using a general linear model with treatment and center as factors, and baseline value as a covariate.||-0.16|-0.58|0.0007
72507569|NCT01455428|144546732|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-7.21|STANDARD_ERROR_OF_MEAN|2.464||0.0039|TWO_SIDED|95.0|-12.08|-2.35||Analysis was two-sided and performed at the 0.05 significance level.|ANCOVA|||Analysis performed using a general linear model with treatment and center as factors, and baseline value as a covariate.||-2.35|-12.08|0.0039
72507570|NCT01455428|144546733|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|1.73|STANDARD_ERROR_OF_MEAN|2.783||0.5351|TWO_SIDED|95.0|-3.76|7.22||Analysis was two-sided and performed at the 0.05 significance level.|ANCOVA|||Analysis performed using a general linear model with treatment and center as factors, and baseline value as a covariate.||7.22|-3.76|0.5351
72507571|NCT01455428|144546734|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.36|STANDARD_ERROR_OF_MEAN|2.579||0.8892|TWO_SIDED|95.0|-5.45|4.73||Analysis was two-sided and performed at the 0.05 significance level.|ANCOVA|||Analysis performed using a general linear model with treatment and center as factors, and baseline value as a covariate.||4.73|-5.45|0.8892
72507572|NCT01455428|144546735|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|0.43|STANDARD_ERROR_OF_MEAN|0.147||0.0035|TWO_SIDED|95.0|0.14|0.72||Analysis was two-sided and performed at the 0.05 significance level.|ANCOVA|||Analysis performed using a general linear model with treatment and center as factors, and baseline value as a covariate.||0.72|0.14|0.0035
72507573|NCT01455428|144546736|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.8||||0.0972|TWO_SIDED|95.0|0.9|3.6||Analysis was two-sided and performed at the 0.05 significance level.|Regression, Logistic|||Analysis performed using a logistic regression model with treatment and center as factors, and baseline value as a covariate.||3.60|0.90|0.0972
72507574|NCT01455428|144546737|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|1.8|STANDARD_ERROR_OF_MEAN|3.161||0.5702|TWO_SIDED|95.0|-4.44|8.03||Analysis was two-sided and performed at the 0.05 significance level.|ANCOVA|||Analysis performed using a general linear model with treatment and center as factors, and baseline value as a covariate.||8.03|-4.44|0.5702
72507575|NCT01455428|144546738|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|0.87|STANDARD_ERROR_OF_MEAN|2.194||0.6929|TWO_SIDED|95.0|-3.46|5.2||Analysis was two-sided and performed at the 0.05 significance level.|ANCOVA|||Analysis performed using a general linear model with treatment and center as factors, and baseline value as a covariate.||5.20|-3.46|0.6929
72507576|NCT01455428|144546739|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-2.84|STANDARD_ERROR_OF_MEAN|1.92||0.1403|TWO_SIDED|95.0|-6.63|0.94||Analysis was two-sided and performed at the 0.05 significance level.|ANCOVA|||Analysis performed using a general linear model with treatment and center as factors, and baseline value as a covariate.||0.94|-6.63|0.1403
72507577|NCT01455428|144546740|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.62|STANDARD_ERROR_OF_MEAN|0.118|<|0.0001|TWO_SIDED|95.0|-0.86|-0.39||Analysis was two-sided and performed at the 0.05 significance level.|ANOVA|||Analysis was performed using a general linear model with treatment and center as factors.||-0.39|-0.86|<0.0001
72507578|NCT01455428|144546741|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.49|STANDARD_ERROR_OF_MEAN|0.113|<|0.0001|TWO_SIDED|95.0|-0.72|-0.27||Analysis was two-sided and performed at the 0.05 significance level.|ANOVA|||Analysis was performed using a general linear model with treatment and center as factors.||-0.27|-0.72|<0.0001
72507579|NCT01455428|144546743|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.21|STANDARD_ERROR_OF_MEAN|0.315||0.506|TWO_SIDED|95.0|-0.83|0.41||Analysis was two-sided and performed at the 0.05 significance level.|ANCOVA|||Analysis was performed using a general linear model with treatment and center as factors, and the baseline value as a covariate.||0.41|-0.83|0.5060
72398779|NCT00183092|144304013|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.8||||0.7||95.0||||Significance threshold p\<0.05|ANCOVA|||The difference between change scores, adjusted for Month-0 performance. Positive adjusted differences indicate greater adjusted change (worsening) in the placebo group; negative indicate greater adjusted change (worsening) in the quinacrine group.||||0.70
72398780|NCT03060447|144304015|SUPERIORITY|||||||0.55|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||Dose 1: Day 2||||0.55
72398781|NCT03060447|144304015|SUPERIORITY|||||||0.54|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||Dose 1: Day 8||||0.54
72566210|NCT00484419|144663059|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||P-value presents results from 1-sample t-test for within-treatment difference from baseline.||||<0.0001
72566211|NCT00484419|144663059|SUPERIORITY_OR_OTHER|||||||0.1864||95.0|||||t-test, 2 sided|||P-value presents results from 1-sample t-test for within-treatment difference from baseline.||||0.1864
72566212|NCT00484419|144663059|SUPERIORITY_OR_OTHER|||||||0.0999||95.0|||||t-test, 2 sided|||P-value presents results from 1-sample t-test for within-treatment difference from baseline.||||0.0999
72566213|NCT00484419|144663060|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||P-value presents results from 1-sample t-test for within-treatment difference from baseline.||||<0.0001
72566214|NCT00484419|144663060|SUPERIORITY_OR_OTHER|||||||0.0566||95.0|||||t-test, 2 sided|||P-value presents results from 1-sample t-test for within-treatment difference from baseline.||||0.0566
72566215|NCT00484419|144663060|SUPERIORITY_OR_OTHER|||||||0.0217||95.0|||||t-test, 2 sided|||P-value presents results from 1-sample t-test for within-treatment difference from baseline.||||0.0217
72566216|NCT03095118|144663097|SUPERIORITY|||||||0.001|||||||t-test, 2 sided|||Proteinuria baseline values compared to 6 month follow up values||||0.001
72566217|NCT03095118|144663098|SUPERIORITY|||||||0.004|||||||t-test, 2 sided|||Proteinuria baseline values compared to 12 month follow up values||||0.004
72566218|NCT03095118|144663100|SUPERIORITY|||||||0.15|||||||t-test, 2 sided|||Serum creatinine baseline values compared to 6 month follow up values||||0.15
72566219|NCT03095118|144663101|SUPERIORITY|||||||0.16|||||||t-test, 2 sided|||Serum creatinine baseline values comparted to 12 month follow up values||||0.16
72566220|NCT03176784|144663123|SUPERIORITY||Odds Ratio (OR)|0.9||||0.66|TWO_SIDED|95.0|0.6|1.3|||Regression, Logistic|Study site (Madison vs Milwaukee) was included as a covariate.||||1.3|0.6|.66
72566221|NCT03176784|144663123|SUPERIORITY||Odds Ratio (OR)|1.0||||0.85|TWO_SIDED|95.0|0.7|1.4|||Regression, Logistic|Study site (Madison vs Milwaukee) was included as a covariate.||||1.4|0.7|.85
72398782|NCT03060447|144304015|SUPERIORITY|||||||0.54|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||Dose 2: Day 1||||0.54
72566222|NCT03176784|144663123|SUPERIORITY||Odds Ratio (OR)|1.0||||1|TWO_SIDED|95.0|0.7|1.4|||Regression, Logistic|Study site (Madison vs Milwaukee) was included as a covariate.||||1.4|0.7|1.00
72566223|NCT03176784|144663124|SUPERIORITY||Odds Ratio (OR)|1.2||||0.44|TWO_SIDED|95.0|0.8|1.7||Study site (Madison vs Milwaukee) was included as a covariate.|Regression, Logistic|||||1.7|0.8|.44
72566224|NCT03176784|144663124|SUPERIORITY||Odds Ratio (OR)|1.1||||0.61|TWO_SIDED|95.0|0.8|1.6|||Regression, Logistic|Study site (Madison vs Milwaukee) was included as a covariate.||||1.6|0.8|.61
72566225|NCT03176784|144663124|SUPERIORITY||Odds Ratio (OR)|1.4||||0.12|TWO_SIDED|95.0|0.9|2.0|||Regression, Logistic|Study site (Madison vs Milwaukee) was included as a covariate.||||2.0|0.9|.12
72566226|NCT03176784|144663125|SUPERIORITY||Odds Ratio (OR)|0.8||||0.43|TWO_SIDED|95.0|0.5|1.3|||Regression, Logistic|Study site (Madison vs Milwaukee) was included as a covariate.||||1.3|0.5|.43
72566227|NCT03176784|144663125|SUPERIORITY||Odds Ratio (OR)|0.8||||0.37|TWO_SIDED|95.0|0.5|1.3|||Regression, Logistic|Study site (Madison vs Milwaukee) was included as a covariate.||||1.3|0.5|.37
72566228|NCT03176784|144663125|SUPERIORITY||Odds Ratio (OR)|1.1||||0.81|TWO_SIDED|95.0|0.7|1.6|||Regression, Logistic|Study site (Madison vs Milwaukee) was included as a covariate.||||1.6|0.7|.81
72566229|NCT03176784|144663126|SUPERIORITY||Odds Ratio (OR)|0.9||||0.65|TWO_SIDED|95.0|0.6|1.3|||Regression, Logistic|Study site (Madison vs Milwaukee) was included as a covariate.||||1.3|0.6|.65
72566230|NCT03176784|144663126|SUPERIORITY||Odds Ratio (OR)|0.9||||0.6|TWO_SIDED|95.0|0.6|1.3|||Regression, Logistic|Study site (Madison vs Milwaukee) was included as a covariate.||||1.3|0.6|.60
72566231|NCT03176784|144663126|SUPERIORITY||Odds Ratio (OR)|1.0||||0.86|TWO_SIDED|95.0|0.7|1.5|||Regression, Logistic|Study site (Madison vs Milwaukee) was included as a covariate.||||1.5|0.7|.86
72566232|NCT02646917|144663132|SUPERIORITY||||||<|0.008|||||||Wilcoxon (Mann-Whitney)|||Goodman and Baron's qualitative acne scar severity scores. Calculated from Wilcoxon signed-rank test. Testing hypothesis is that the mean change from baseline is equal to zero.||||<0.008
72566233|NCT02646917|144663133|SUPERIORITY||||||<|0.001|||||||Wilcoxen signed-rank test|||Null hypothesis 4 (no change).||||<.001
72566234|NCT02646917|144663134|SUPERIORITY||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||Calculated from Wilcoxon signed-rank test. The testing hypothesis is that the mean change from baseline is equal to zero||||<0.01
72398783|NCT03060447|144304015|SUPERIORITY|||||||0.54|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||Dose 2: Day 8||||0.54
72398784|NCT03060447|144304015|SUPERIORITY|||||||0.54|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||Dose 3: Day 1||||0.54
72398785|NCT03060447|144304015|SUPERIORITY|||||||0.57|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||Dose 3: Day 8||||0.57
72398786|NCT03060447|144304015|SUPERIORITY|||||||0.54|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||Dose 4: Day 1||||0.54
72398787|NCT03060447|144304015|SUPERIORITY|||||||0.52|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||Dose 4: Day 2||||0.52
72398788|NCT03060447|144304015|SUPERIORITY|||||||0.52|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||Dose 4: Day 4||||0.52
72398789|NCT03060447|144304015|SUPERIORITY|||||||0.61|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||Dose 4: Day 8||||0.61
72398790|NCT03060447|144304015|SUPERIORITY|||||||0.54|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||Dose 5: Day 1||||0.54
72566235|NCT02646917|144663135|SUPERIORITY||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||Calculated from Wilcoxon signed-rank test. The testing hypothesis is that the mean score is equal to 0 (no change in the appearance of acne scars).||||<0.01
72566236|NCT02646917|144663136|SUPERIORITY||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|Calculated from Wilcoxon signed-rank test. Testing hypothesis is that the mean score is equal to 4 (no change).||||||<0.01
72566237|NCT00680186|144663137|NON_INFERIORITY_OR_EQUIVALENCE|Non inferiority margin was set up to 2.75 for the HR analysis|Hazard Ratio (HR)|1.13||||0.0002||95.0|0.69|1.85||Non-inferiority P-Value.Two co-primary analyses performed on primary endpoint. Both non inferiority for the risk difference (RD) (at day 180) and for the HR (up to end of ptp) analyses to be reached in order to conclude positively on primary endpoint|Regression, Cox|Patients without events are censored at the end of ptp.||Hazard ratio (HR) vs. Warfarin (events occurring between randomisation and end of ptp). The time to first occurrence of the primary endpoint was compared between treatment groups using the Cox proportional hazards (PH) model, including the factors treatment, active cancer at baseline, symptomatic PE at baseline, and the interaction between active cancer and symptomatic PE.||1.85|0.69|0.0002
72566238|NCT00680186|144663137|NON_INFERIORITY_OR_EQUIVALENCE|Non inferiority margin was set up to 3.6% for the RD based on KM estimates|Risk Difference (Percentage)|0.2|||<|0.0001||95.0|-1.0|1.3||Non-inferiority P-Value.Two co-primary analyses performed on primary endpoint. Both non inferiority for the RD (at day 180) and for the HR (events up to end of ptp) analyses to be reached in order to conclude positively on the primary endpoint.|Kaplan Meier weighted estimates|||RD vs. Warfarin for Proportion of patients with VTE or death related to VTE at 6 months. Point estimate and 95% CI for the overall RD obtained based on the Kaplan Meier (KM) estimates at 6 months (180 days) after adjusting for the stratification factors active cancer at baseline and symptomatic PE at baseline.||1.3|-1.0|<0.0001
72566239|NCT00680186|144663137|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.08||||||95.0|0.64|1.8|||Regression, Cox|Patients without events are censored at the earliest of last contact date or day 180.||HR vs. Warfarin (events occurring between randomisation and day 180). The time to first occurrence of the primary endpoint was compared between treatment groups using the Cox PH model, including the factors treatment, active cancer at baseline, symptomatic PE at baseline, and the interaction between active cancer and symptomatic PE. This analysis was performed as sensitivity analysis for statistical analysis 1.||1.8|0.64|
72398791|NCT03060447|144304015|SUPERIORITY|||||||0.52|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||Dose 5: Day 8||||0.52
72475526|NCT02576587|144476427|OTHER|Conditional logistic regression was used to assess the relationship of PAF and LA volume index on matched pairs of case and control.|Odds Ratio (OR)|1.03|STANDARD_ERROR_OF_MEAN|0.015||0.03|TWO_SIDED|95.0|1.0|1.06|||Conditional logistic regression|N=268 (134 cases and 134 controls)||||1.06|1.00|0.030
72398792|NCT03060447|144304015|SUPERIORITY|||||||0.52|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||Dose 6: Day 1||||0.52
72398793|NCT03060447|144304015|SUPERIORITY|||||||0.52|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests||Dose 6: Day 4||||0.52
72398794|NCT03060447|144304015|SUPERIORITY|||||||0.52|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||Dose 6: Day 8||||0.52
72398795|NCT03060447|144304015|SUPERIORITY|||||||0.52|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||Dose 7: Day 1||||0.52
72398796|NCT03060447|144304015|SUPERIORITY|||||||0.52|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||Dose 7 - Day 8||||0.52
72398797|NCT03060447|144304015|SUPERIORITY|||||||0.52|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||Dose 8: Day 1||||0.52
72398798|NCT03060447|144304015|SUPERIORITY|||||||0.52|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||Dose 8: Day 8||||0.52
72398799|NCT03060447|144304015|SUPERIORITY|||||||0.52|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||Dose 9: Day 1||||0.52
72398800|NCT03060447|144304015|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests||Dose 9: Day 8||||1.00
72398801|NCT03060447|144304015|SUPERIORITY|||||||0.52|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests||Dose 10: Day 1||||0.52
72398802|NCT03060447|144304015|SUPERIORITY|||||||0.52|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||Dose 10: Day 2||||0.52
72398803|NCT03060447|144304015|SUPERIORITY|||||||0.52|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||Dose 10: Day 4||||0.52
72398804|NCT03060447|144304015|SUPERIORITY|||||||0.52|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||Dose 10: Day 8||||0.52
72398805|NCT03060447|144304015|SUPERIORITY|||||||0.52|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||Dose 10: Day 14||||0.52
72398806|NCT03060447|144304016|SUPERIORITY|||||||0.035|||||||Log Rank|P-value between treatment groups was based on log-rank test.||≥ 50 Copies/mL||||0.035
72398807|NCT03060447|144304016|SUPERIORITY|||||||0.024|||||||Log Rank|P-value between treatment groups was based on log-rank test.||≥ 200 Copies/mL||||0.024
72398808|NCT03060447|144304017|SUPERIORITY|||||||0.67|||||||Wilcoxon (Mann-Whitney)|P-values between treatment groups were based on Wilcoxon rank sum test.||||||0.67
72398809|NCT03060447|144304018|SUPERIORITY|||||||0.78|||||||Wilcoxon (Mann-Whitney)|P-values between treatment groups were based on Wilcoxon rank sum test.||||||0.78
72398810|NCT03060447|144304019|SUPERIORITY|||||||0.34|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||IFN-a, Baseline||||0.34
72398811|NCT03060447|144304019|SUPERIORITY|||||||0.11|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||IFN-a, Dose 1: Day 2||||0.11
72475527|NCT02576587|144476427|OTHER|Conditional logistic regression was used to assess the relationship of PAF and LA systolic strain apical four-chamber (A4C) on matched pairs of case and control.|Odds Ratio (OR)|0.99|STANDARD_ERROR_OF_MEAN|0.013||0.39|TWO_SIDED|95.0|0.96|1.01|||Conditional logistic regression|N=214 (107 cases and 107 controls)||||1.01|0.96|0.39
72475528|NCT02576587|144476427|OTHER|Conditional logistic regression was used to assess the relationship of PAF and LA systolic strain apical two-chamber (A2C) on matched pairs of case and control.|Odds Ratio (OR)|0.99|STANDARD_ERROR_OF_MEAN|0.013||0.49|TWO_SIDED|95.0|0.97|1.02|||Conditional logistic regression|N=212 (106 cases and 106 controls)||||1.02|0.97|0.49
72475529|NCT02576587|144476428|OTHER||median of change|3.4||||0.16|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|Wilcoxon signed rank test was used to compare pre- and post- treatment outcomes.|||Inter-Quartile Range of the change (post minus pre) is (-7.0, 13.7).|||0.16
72475530|NCT02576587|144476429|OTHER||median of change|1.8||||0.088|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|Wilcoxon signed rank test was used to compare pre- and post- treatment outcomes.|Inter-quartile range of the change (post minus pre) is (-2.0, 6.0).|||||0.088
72507580|NCT01455428|144546744|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.285||0.7247|TWO_SIDED|95.0|-0.66|0.46||Analysis was two-sided and performed at the 0.05 significance level.|ANCOVA|||Analysis was performed using a general linear model with treatment and center as factors, and the baseline value as a covariate.||0.46|-0.66|0.7247
72398812|NCT03060447|144304019|SUPERIORITY|||||||0.81|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||IFN-a, Dose 1: Day 8||||0.81
72398813|NCT03060447|144304019|SUPERIORITY|||||||0.83|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||IFN-a, Dose 4: Day 1||||0.83
72475531|NCT02576587|144476430|OTHER||median of change|-3.7||||0.006|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|Wilcoxon signed rank test was used to compare pre- and post- treatment outcomes.|Inter-quartile range of the change (post minus pre) is (-8.0, -0.57).|||||0.006
72475532|NCT02576587|144476431|OTHER||median of change|-0.7||||0.59|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|Wilcoxon signed rank test was used to compare pre- and post- treatment outcomes.|Inter-quartile range of the change (post minus pre) is (-6.2, 10.7).|||||0.59
72475533|NCT02576587|144476432|OTHER||mean of change|0.62|STANDARD_DEVIATION|4.2||0.65|TWO_SIDED||||||t-test, 2 sided|Paired t test was used to compare pre- and post- treatment outcomes.||||||0.65
72475534|NCT02576587|144476433|OTHER||mean of change|-1.7|STANDARD_DEVIATION|12.2||0.65|TWO_SIDED||||||t-test, 2 sided|Paired t test was used to compare pre- and post- treatment outcomes.||||||0.65
72475535|NCT05745701|144476454|OTHER||test/reference ratios|195.9|||||TWO_SIDED|90.0|162.13|236.71||||||Natural loge transformed Cmax of PF-07081532 administered without cyclosporine (Reference) or coadministered with cyclosporine (Test) were analyzed using a mixed effect model with treatment as a fixed effect and participant as a random effect. Estimates of the adjusted mean differences (Test/Reference) and corresponding 90% CIs was obtained from the models. The ratios (and 90% CIs) were expressed as percentages.||236.71|162.13|
72398814|NCT03060447|144304019|SUPERIORITY|||||||0.12|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||IFN-a, Dose 4: Day 2||||0.12
72398815|NCT03060447|144304019|SUPERIORITY|||||||0.45|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||IFN-a, Dose 4: Day 8||||0.45
72398816|NCT03060447|144304019|SUPERIORITY|||||||0.25|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||IFN-a, Dose 10: Day 1||||0.25
72398817|NCT03060447|144304019|SUPERIORITY|||||||0.053|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||IFN-a, Dose 10: Day 2||||0.053
72398818|NCT03060447|144304019|SUPERIORITY|||||||0.16|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||IFN-a, Dose 10: Day 8||||0.16
72398819|NCT03060447|144304019|SUPERIORITY|||||||0.27|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||IFN-a, ATI Remission Visit||||0.27
72398820|NCT03060447|144304019|SUPERIORITY|||||||0.35|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||IL-1RA, Baseline||||0.35
72398821|NCT03060447|144304019|SUPERIORITY|||||||0.013|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||IL-1RA, Dose 1: Day 2||||0.013
72475536|NCT05745701|144476454|OTHER||test/reference ratios|282.13|||||TWO_SIDED|90.0|258.81|307.55||||||Natural loge transformed Cmax of PF-07081532 administered without itraconazole (Reference) or coadministered with itraconazole (Test) were analyzed using a mixed effect model with treatment as a fixed effect and participant as a random effect. Estimates of the adjusted mean differences (Test/Reference) and corresponding 90% CIs was obtained from the models. The ratios (and 90% CIs) were expressed as percentages.||307.55|258.81|
72475537|NCT00422812|144476487|SUPERIORITY|||||||0.0012||||||Overall effect at 2 hr (by Cochran-Mantel-Haenszel) for TREATMENT|Cochran-Mantel-Haenszel|||||||0.0012
72475538|NCT00422812|144476488|SUPERIORITY|||||||0.281|||||||Fisher Exact|||||||0.281
72475539|NCT00422812|144476488|SUPERIORITY|||||||0.0226|||||||Fisher Exact|||||||0.0226
72475540|NCT00422812|144476488|SUPERIORITY|||||||0.0019|||||||Fisher Exact|||||||0.0019
72507581|NCT03303339|144546745|OTHER||Maximum Tolerated Dose|60.0|||||TWO_SIDED|||||||||||||
72507582|NCT00477451|144546758|SUPERIORITY|||||||0.2|||||||Fisher Exact|||||||0.200
72507583|NCT00477451|144546759|SUPERIORITY|||||||0.368|||||||Wilcoxon (Mann-Whitney)|||||||0.368
72623139|NCT01217892|144776797|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.4|STANDARD_ERROR_OF_MEAN|3.132||0.001|TWO_SIDED|95.0|-16.5|-4.2||significant at alpha=0.05 (2-sided). Key secondary endpoints are tested following a hierarchical closed testing procedure within treatment group for treatment groups tested significantly different from placebo for the primary endpoint.|ANCOVA|with treatment group (all treatment groups included) and stratum (HbA1c \<7.0% vs \>=7.0% at randomization) as effect and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0 (with alpha = 0.05, two-sided)||-4.2|-16.5|0.0010
72398822|NCT03060447|144304019|SUPERIORITY|||||||0.15|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||IL-1RA, Dose 1: Day 8||||0.15
72398823|NCT03060447|144304019|SUPERIORITY|||||||0.3|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||IL-1RA, Dose 4: Day 1||||0.30
72398824|NCT03060447|144304019|SUPERIORITY|||||||0.003|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||IL-1RA, Dose 4: Day 2||||0.003
72566240|NCT00680186|144663138|SUPERIORITY_OR_OTHER||Risk Difference (Percentage)|0.3||||0.6932||95.0|-1.1|1.6|||Kaplan Meier weighted estimates|||RD vs. Warfarin for Proportion of patients with VTE or death at 6 months. Point estimate and 95% CI for the overall RD obtained based on the KM estimates at 6 months (180 days) after adjusting for the stratification factors active cancer at baseline and symptomatic PE at baseline.||1.6|-1.1|0.6932
72566241|NCT00680186|144663138|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.09||||0.6383||95.0|0.75|1.6|||Regression, Cox|Patients without events are censored at the end of ptp.||HR vs. Warfarin (events occurring between randomisation and end of ptp). The time to first occurrence of the endpoint was compared between treatment groups using the Cox PH model, including the factors treatment, active cancer at baseline, symptomatic PE at baseline, and the interaction between active cancer and symptomatic PE.||1.60|0.75|0.6383
72566242|NCT00680186|144663139|SUPERIORITY_OR_OTHER||Risk Difference (Percentage)|0.6||||0.1703||95.0|-0.3|1.5|||Kaplan Meier weighted estimates|||RD vs. Warfarin for Proportion of patients with symptomatic DVT at 6 months. Point estimate and 95% CI for the overall RD obtained based on the KM estimates at 6 months (180 days) after adjusting for the stratification factors active cancer at baseline and symptomatic PE at baseline.||1.5|-0.3|0.1703
72566243|NCT00680186|144663139|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.65||||0.1054||95.0|0.9|3.01|||Regression, Cox|Patients without events are censored at the end of ptp.||HR vs. Warfarin (events occurring between randomisation and end of ptp). The time to first occurrence of the endpoint was compared between treatment groups using the Cox PH model, including the factors treatment, active cancer at baseline, symptomatic PE at baseline, and the interaction between active cancer and symptomatic PE.||3.01|0.90|0.1054
72566244|NCT00680186|144663140|SUPERIORITY_OR_OTHER||Risk Difference (Percentage)|-0.4||||0.2283||95.0|-1.1|0.3|||Kaplan Meier weighted estimates|||RD vs. Warfarin for Proportion of patients with symptomatic non-fatal PE at 6 months. Point estimate and 95% CI for the overall RD obtained based on the KM estimates at 6 months (180 days) after adjusting for the stratification factors active cancer at baseline and symptomatic PE at baseline.||0.3|-1.1|0.2283
72566245|NCT00680186|144663140|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.59||||0.2101||95.0|0.26|1.35|||Regression, Cox|||HR vs. Warfarin (events occurring between randomisation and end of ptp). The time to first occurrence of the endpoint was compared between treatment groups using the Cox PH model, including the factors treatment, active cancer at baseline, symptomatic PE at baseline, and the interaction between active cancer and symptomatic PE.||1.35|0.26|0.2101
72566246|NCT00680186|144663141|SUPERIORITY_OR_OTHER||Risk Difference (Percentage)|0.2||||0.083||95.0|0.0|0.5|||Kaplan Meier weighted estimates|||RD at 6 months vs. Warfarin for Proportion of patients who died due to VTE . Point estimate and 95% CI for the overall RD obtained based on the KM estimates at 6 months (180 days) after adjusting for the stratification factors active cancer at baseline and symptomatic PE at baseline.||0.5|0.0|0.0830
72398825|NCT03060447|144304019|SUPERIORITY|||||||0.49|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||IL-1RA, Dose 4: Day 8||||0.49
72398826|NCT03060447|144304019|SUPERIORITY|||||||0.25|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||IL-1RA, Dose 10: Day 1||||0.25
72398827|NCT03060447|144304019|SUPERIORITY|||||||0.055|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||IL-1RA, Dose 10: Day 2||||0.055
72398828|NCT03060447|144304019|SUPERIORITY|||||||0.9|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||IL-1RA, Dose 10: Day 8||||0.90
72398829|NCT03060447|144304019|SUPERIORITY|||||||0.39|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||IL-1RA, ATI Remission Visit||||0.39
72398830|NCT03060447|144304019|SUPERIORITY|||||||0.75|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||IP-10, Baseline||||0.75
72398831|NCT03060447|144304019|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||IP-10, Dose 1: Day 2||||<0.001
72398832|NCT03060447|144304019|SUPERIORITY|||||||0.69|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||IP-10, Dose 1: Day 8||||0.69
72398833|NCT03060447|144304019|SUPERIORITY|||||||0.15|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||IP-10, Dose 4: Day 1||||0.15
72398834|NCT03060447|144304019|SUPERIORITY|||||||0.018|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||IP-10, Dose 4: Day 2||||0.018
72398835|NCT03060447|144304019|SUPERIORITY|||||||0.03|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||IP-10, Dose 4: Day 8||||0.030
72398836|NCT03060447|144304019|SUPERIORITY|||||||0.087|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||IP-10, Dose 10: Day 1||||0.087
72398837|NCT03060447|144304019|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||IP-10, Dose 10: Day 2||||<0.001
72398838|NCT03060447|144304019|SUPERIORITY|||||||0.066|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||IP-10, Dose 10: Day 8||||0.066
72398839|NCT03060447|144304019|SUPERIORITY|||||||0.86|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||IP-10, ATI Remission||||0.86
72398840|NCT03060447|144304019|SUPERIORITY|||||||0.19|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||ITAC, Baseline||||0.19
72398841|NCT03060447|144304019|SUPERIORITY|||||||0.021|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||ITAC, Dose 1: Day 2||||0.021
72507584|NCT00477451|144546760|SUPERIORITY|||||||0.207|||||||t-test, 2 sided|||||||0.207
72398842|NCT03060447|144304019|SUPERIORITY|||||||0.31|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||ITAC, Dose 1: Day 8||||0.31
72398843|NCT03060447|144304019|SUPERIORITY|||||||0.1|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||ITAC, Dose 4: Day 1||||0.10
72398844|NCT03060447|144304019|SUPERIORITY|||||||0.018|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||ITAC, Dose 4: Day 2||||0.018
72398845|NCT03060447|144304019|SUPERIORITY|||||||0.69|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||ITAC, Dose 4: Day 8||||0.69
72398846|NCT03060447|144304019|SUPERIORITY|||||||0.46|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||ITAC, Dose 10: Day 1||||0.46
72398847|NCT03060447|144304019|SUPERIORITY|||||||0.21|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||ITAC, Dose 10: Day 2||||0.21
72398848|NCT03060447|144304019|SUPERIORITY|||||||0.67|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||ITAC, Dose 10: Day 8||||0.67
72398849|NCT03060447|144304019|SUPERIORITY|||||||0.6|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||ITAC, ATI Remission||||0.60
72398850|NCT03060447|144304020|SUPERIORITY|||||||0.002|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||ISG15, Dose 1: Day 2||||0.002
72398851|NCT03060447|144304020|SUPERIORITY|||||||0.58|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||ISG15, Dose 4: Day 1||||0.58
72507585|NCT00455858|144546780|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean|-1.356|||<|0.0001||95.0|-1.368|-1.344|||t-test|||||-1.344|-1.368|<.0001
72507586|NCT00455858|144546781|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean|-1.338|||<|0.0001||95.0|-1.35|-1.327|||t-test|||||-1.327|-1.350|<.0001
72398852|NCT03060447|144304020|SUPERIORITY|||||||0.009|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||ISG15, Dose 4: Day 2||||0.009
72398853|NCT03060447|144304020|SUPERIORITY|ISG15, Dose 10: Day 1||||||0.031|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||||||0.031
72398854|NCT03060447|144304020|SUPERIORITY|||||||0.001|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||ISG15, Dose 10: Day 2||||0.001
72398855|NCT03060447|144304020|SUPERIORITY|||||||0.003|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||OAS-1, Dose 1: Day 2||||0.003
72398856|NCT03060447|144304020|SUPERIORITY|||||||0.057|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||OAS-1, Dose 4: Day 1||||0.057
72398857|NCT03060447|144304020|SUPERIORITY|||||||0.009|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||OAS-1, Dose 4: Day 2||||0.009
72398858|NCT03060447|144304020|SUPERIORITY|||||||0.057|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||OAS-1, Dose 10: Day 1||||0.057
72398859|NCT03060447|144304020|SUPERIORITY|||||||0.005|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||OAS-1, Dose 10: Day 2||||0.005
72398860|NCT03060447|144304020|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||MX1, Dose 1: Day 2||||<0.001
72398861|NCT03060447|144304020|SUPERIORITY|||||||0.17|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||MX1, Dose 4: Day 1||||0.17
72507587|NCT00455858|144546782|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean|-69.553|||<|0.0001||95.0|-70.047|-69.06|||Paired t-test|||Estimated mean decrease in FPG at week 12||-69.060|-70.047|<.0001
72507588|NCT00455858|144546782|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean|-72.159|||<|0.0001||95.0|-72.647|-71.671|||Paired t-test|||Estimated mean decrease in FPG at week 20||-71.671|-72.647|<.0001
72507589|NCT01052012|144546834|SUPERIORITY||LS Mean Difference (Final Values)|-0.89|STANDARD_ERROR_OF_MEAN|0.597||0.1473|TWO_SIDED|95.0|-2.11|0.33|||ANCOVA|With pooled site and treatment group as factors and incision length as a covariate.||||0.33|-2.11|0.1473
72507590|NCT01052012|144546834|SUPERIORITY||LS Mean Difference (Final Values)|-1.06|STANDARD_ERROR_OF_MEAN|0.547||0.0601|TWO_SIDED|95.0|-2.16|0.05|||ANCOVA|with pooled site and treatment group as factors and incision length as a covariate.||||0.05|-2.16|0.0601
72507591|NCT01052012|144546834|SUPERIORITY||LS Mean Difference (Final Values)|-0.34|STANDARD_ERROR_OF_MEAN|0.233||0.1483|TWO_SIDED|95.0|-0.8|0.12|||ANCOVA|with pooled site and treatment group as factors and incision length as a covariate.||||0.12|-0.80|0.1483
72507592|NCT01052012|144546835|SUPERIORITY||Median Difference (Hodge-Lehmann)|-1.0||||0.9901|TWO_SIDED|95.0|-54.5|52.0|||Wilcoxon (Mann-Whitney)|||||52.0|-54.5|0.9901
72507593|NCT01052012|144546835|SUPERIORITY||Median Difference (Hodge-Lehmann)|-5.0||||0.201|TWO_SIDED|95.0|-14.0|3.4|||Wilcoxon Rank-Sum|||||3.4|-14.0|0.2010
72507594|NCT01052012|144546835|SUPERIORITY||Median Difference (Hodge-Lehmann)|-3.0||||0.5897|TWO_SIDED|95.0|-15.0|8.0|||Wilcoxon Rank-Sum|||||8.0|-15.0|0.5897
72398862|NCT03060447|144304020|SUPERIORITY|||||||0.003|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||MX1, Dose 4: Day 2||||0.003
72398863|NCT03060447|144304020|SUPERIORITY|MX1, Dose 10: Day 1||||||0.1|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||||||0.100
72398864|NCT03060447|144304020|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||MX1, Dose 10: Day 2||||<0.001
72398865|NCT03060447|144304021|SUPERIORITY|||||||0.7469|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||CD4/CD38/HLADR, Baseline||||0.7469
72398866|NCT03060447|144304021|SUPERIORITY|||||||0.1207|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||CD4/CD38/HLADR, Dose 4: Day 1||||0.1207
72398867|NCT03060447|144304021|SUPERIORITY|||||||0.4113|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||CD4/CD38/HLADR, Dose 4: Day 2||||0.4113
72398868|NCT03060447|144304021|SUPERIORITY|||||||0.1113|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||CD4/CD38/HLADR, Dose 4: Day 4||||0.1113
72398869|NCT03060447|144304021|SUPERIORITY|||||||0.241|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||CD4/CD38/HLADR, Dose 6: Day 1||||0.2410
72398870|NCT03060447|144304021|SUPERIORITY|||||||0.1098|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||CD4/CD38/HLADR, Dose 6: Day 4||||0.1098
72398871|NCT03060447|144304021|SUPERIORITY|||||||0.0369|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||CD4/CD38/HLADR, Dose 10: Day 1||||0.0369
72507595|NCT02873715|144546843|SUPERIORITY||Mean Difference (Final Values)|-6.21|||<|0.05|TWO_SIDED|95.0|-10.14|-2.29|||ANCOVA||Results are pooled across 10 multiple imputations and reported as mean (standard error)|||-2.29|-10.14|<0.05
72398872|NCT03060447|144304021|SUPERIORITY|||||||0.0814|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||CD4/CD38/HLADR, Dose 10: Day 2||||0.0814
72398873|NCT03060447|144304021|SUPERIORITY|||||||0.1658|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||CD4/CD38/HLADR, Dose 10: Day 4||||0.1658
72398874|NCT03060447|144304021|SUPERIORITY|||||||0.9431|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||CD4/CD38/HLADR, Dose 10: Day 14||||0.9431
72398875|NCT03060447|144304021|SUPERIORITY|||||||0.6514|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||CD8/CD38/HLADR, Baseline||||0.6514
72398876|NCT03060447|144304021|SUPERIORITY|||||||0.0821|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||CD8/CD38/HLADR, Dose 4: Day 1||||0.0821
72398877|NCT03060447|144304021|SUPERIORITY|||||||0.2353|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||CD8/CD38/HLADR, Dose 4: Day 2||||0.2353
72398878|NCT03060447|144304021|SUPERIORITY|||||||0.1779|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||CD8/CD38/HLADR, Dose 4: Day 4||||0.1779
72398879|NCT03060447|144304021|SUPERIORITY|||||||0.7491|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||CD8/CD38/HLADR, Dose 6: Day 1||||0.7491
72398880|NCT03060447|144304021|SUPERIORITY|||||||0.07|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||CD8/CD38/HLADR, Dose 6: Day 4||||0.0700
72507596|NCT02873715|144546844|SUPERIORITY||Mean Difference (Final Values)|-3.97||||0.001|TWO_SIDED|95.0|-5.68|-2.26|||ANCOVA||Results are pooled across 10 multiple imputations and reported as mean (standard error)|||-2.26|-5.68|0.001
72507597|NCT02873715|144546846|SUPERIORITY||Mean Difference (Final Values)|-0.5384||||0.65|TWO_SIDED||||||ANOVA|time x group analysis.||repeated measures analysis of variance for parent delay discounting changes from 0 to 24-month. This includes only parents with complete data for both time points and does not exclude based on johnson-bickel rules. Reporting time x group analysis.||||0.65
72507598|NCT02873715|144546846|SUPERIORITY||Mean Difference (Net)|-0.3913||||0.87|TWO_SIDED|||||time x group analysis|ANOVA|||repeated measures analysis of variance for child delay discounting changes from 0 to 24-month. This includes only parents with complete data for both time points and does not exclude based on johnson-bickel rules. Reporting time x group analysis.||||0.87
72507599|NCT00492401|144546854|SUPERIORITY_OR_OTHER|||||||0.02|||||||Wilcoxon (Mann-Whitney)|||Expression levels of miR-29b in pre treatment marrow samples from responding or non responding patients were compared using Wilcoxon rank sum tests||||.02
72398881|NCT03060447|144304021|SUPERIORITY|||||||0.3711|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||CD8/CD38/HLADR, Dose 10: Day 1||||0.3711
72398882|NCT03060447|144304021|SUPERIORITY|||||||0.0814|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||CD8/CD38/HLADR, Dose 10: Day 2||||0.0814
72398883|NCT03060447|144304021|SUPERIORITY|||||||0.07|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||CD8/CD38/HLADR, Dose 10: Day 4||||0.0700
72398884|NCT03060447|144304021|SUPERIORITY|||||||0.8303|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||CD8/CD38/HLADR, Dose 10: Day 14||||0.8303
72398885|NCT03060447|144304021|SUPERIORITY|||||||0.953|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||CD69+CD56+CD16+, Baseline||||0.9530
72398886|NCT03060447|144304021|SUPERIORITY|||||||0.1735|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||CD69+CD56+CD16+, Dose 4: Day 1||||0.1735
72398887|NCT03060447|144304021|SUPERIORITY|||||||0.2971|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||CD69+CD56+CD16+, Dose 4: Day 2||||0.2971
72398888|NCT03060447|144304021|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||CD69+CD56+CD16+, Dose 4: Day 4||||1.0000
72398889|NCT03060447|144304021|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||CD69+CD56+CD16+, Dose 6: Day 1||||1.0000
72398890|NCT03060447|144304021|SUPERIORITY|||||||0.3374|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||CD69+CD56+CD16+, Dose 6: Day 4||||0.3374
72398891|NCT03060447|144304021|SUPERIORITY|||||||0.7656|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||CD69+CD56+CD16+, Dose 10: Day 1||||0.7656
72623140|NCT01217892|144776797|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.3|STANDARD_ERROR_OF_MEAN|3.139|<|0.0001|TWO_SIDED|95.0|-21.4|-9.1||significant at alpha=0.05 (2-sided). Key secondary endpoints are tested following a hierarchical closed testing procedure within treatment group for treatment groups tested significantly different from placebo for the primary endpoint.|ANCOVA|with treatment group (all treatment groups included) and stratum (HbA1c \<7.0% vs \>=7.0% at randomization) as effect and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0 (with alpha = 0.05, two-sided)||-9.1|-21.4|<0.0001
72623141|NCT01217892|144776798|SUPERIORITY_OR_OTHER||Risk Difference (RD)|12.2|STANDARD_ERROR_OF_MEAN|6.097||0.0455|TWO_SIDED|95.0|0.2|24.1||significant at alpha=0.05 (2-sided). Key secondary endpoints are tested following a hierarchical closed testing procedure within treatment group for treatment groups tested significantly different from placebo for the primary endpoint.|Regression, Logistic|Methodology of Zhang, Tsiatis \& Davidian and Davidian, Tsiatis, Zhang \& Lu, with adjustment for baseline value.||H0: proportion(treat) minus proportion(placebo) = 0 versus the alternative HA: proportion(treat) minus proportion(placebo) =/= 0||24.1|0.2|0.0455
72623142|NCT01217892|144776798|SUPERIORITY_OR_OTHER||Risk Difference (RD)|16.8|STANDARD_ERROR_OF_MEAN|6.153||0.0062|TWO_SIDED|95.0|4.8|28.9||significant at alpha=0.05 (2-sided). Key secondary endpoints are tested following a hierarchical closed testing procedure within treatment group for treatment groups tested significantly different from placebo for the primary endpoint.|Regression, Logistic|Methodology of Zhang, Tsiatis \& Davidian and Davidian, Tsiatis, Zhang \& Lu, with adjustment for baseline value.||H0: proportion(treat) minus proportion(placebo) = 0 versus the alternative HA: proportion(treat) minus proportion(placebo) =/= 0||28.9|4.8|0.0062
72623143|NCT01052779|144776800|NON_INFERIORITY|Non-inferiority was concluded if the lower bound of the 95% CI was ≥-0.5 g/dL and superiority if the lower bound was ≥0 g/dL.|Treatment Difference|0.1||||0.515|TWO_SIDED|95.0|-0.21|0.41||The p-value for hemoglobin change from Baseline (Day 1) was adjusted for baseline hemoglobin level and hemodialysis status.|ANOVA||The 95% CI for hemoglobin change from Baseline (Day 1) was from an ANOVA model and adjusted for baseline hemoglobin level and hemodialysis status.|With LOCF Imputation: The p-value and two-sided 95% confidence interval (CI) for the treatment difference in mean change in hemoglobin from Baseline (Day 1) to Week 5 were generated based on an analysis of variance (ANOVA) model adjusted for baseline hemoglobin level and hemodialysis status.||0.41|-0.21|0.515
72623144|NCT01052779|144776800|NON_INFERIORITY|Non-inferiority was concluded if the lower bound of the 95% CI was ≥-0.5 g/dL and superiority if the lower bound was ≥0 g/dL.|Treatment Difference|0.09||||0.587|TWO_SIDED|95.0|-0.23|0.41||The p-value for hemoglobin change from Baseline (Day 1) was adjusted for baseline hemoglobin level and hemodialysis status.|ANOVA||The 95% CI for hemoglobin change from Baseline (Day 1) was from an ANOVA model and adjusted for baseline hemoglobin level and hemodialysis status.|Without Imputation (Sensitivity Analysis): The p-value and two-sided 95% CI for the treatment difference in mean change in hemoglobin from Baseline (Day 1) to Week 5 were generated based on an ANOVA model adjusted for baseline hemoglobin level and hemodialysis status.||0.41|-0.23|0.587
72507600|NCT00492401|144546854|SUPERIORITY_OR_OTHER|||||||0.06|||||||Wilcoxon (Mann-Whitney)|||Expression levels of DNMT3a in pre treatment marrow samples from responding or non responding patients were compared using Wilcoxon rank sum tests||||.06
72623145|NCT03802916|144776804|SUPERIORITY|||||||0.0074||||||A p-value was calculated for the one-sample proportion test.|One-sample proportion test|||One-sample proportion test to determine if the overall preference for deferiprone DR was greater than chance (i.e., a 50% preference for each formulation)||||0.0074
72623146|NCT03802916|144776804|SUPERIORITY|||||||0.0002||||||A p-value was calculated for the one-sample proportion test.|One-sample proportion test|||One-sample proportion test to determine if the overall preference for deferiprone DR was greater than chance (i.e., a 50% preference for each formulation)||||0.0002
72623147|NCT04023045|144776850|OTHER||||||||||||||||||Descriptive analyses (mean and standard deviation) were used to compare the Habitual condition to the Assist-Knee conditions.|||
72623148|NCT04023045|144776851|OTHER||||||||||||||||||Descriptive analyses (mean and standard deviation) were used to compare the Habitual condition to the Assist-Knee conditions.|||
72623149|NCT04023045|144776852|OTHER||||||||||||||||||Descriptive analyses (mean and standard deviation) were used to compare the Habitual condition to the Assist-Knee conditions.|||
72623150|NCT04023045|144776853|OTHER||||||||||||||||||Descriptive analyses (mean and standard deviation) were used to compare the Habitual condition to the Assist-Knee conditions.|||
72398892|NCT03060447|144304021|SUPERIORITY|||||||0.0814|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||CD69+CD56+CD16+, Dose 10: Day 2||||0.0814
72398893|NCT03060447|144304021|SUPERIORITY|||||||0.3374|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||CD69+CD56+CD16+, Dose 10: Day 4||||0.3374
72398894|NCT03060447|144304021|SUPERIORITY|||||||0.432|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||CD69+CD56+CD16+, Dose 10: Day 14||||0.4320
72398895|NCT03060447|144304021|SUPERIORITY|||||||0.8597|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||CD69+CD56dimCD16neg, Baseline||||0.8597
72398896|NCT03060447|144304021|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||CD69+CD56dimCD16neg, Dose 4: Day 1||||1.0000
72398897|NCT03060447|144304021|SUPERIORITY|||||||0.0306|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||CD69+CD56dimCD16neg, Dose 4: Day 2||||0.0306
72398898|NCT03060447|144304021|SUPERIORITY|||||||0.8345|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||CD69+CD56dimCD16neg, Dose 4: Day 4||||0.8345
72398899|NCT03060447|144304021|SUPERIORITY|||||||0.9151|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||CD69+CD56dimCD16neg, Dose 6: Day 1||||0.9151
72398900|NCT03060447|144304021|SUPERIORITY|||||||0.1098|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||CD69+CD56dimCD16neg, Dose 6: Day 4||||0.1098
72398901|NCT03060447|144304021|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||CD69+CD56dimCD16neg, Dose 10: Day 1||||1.0000
72398902|NCT03060447|144304021|SUPERIORITY|||||||0.0814|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||CD69+CD56dimCD16neg, Dose 10: Day 2||||0.0814
72398903|NCT03060447|144304021|SUPERIORITY|||||||0.4555|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||CD69+CD56dimCD16neg, Dose 10: Day 4||||0.4555
72566247|NCT00680186|144663142|SUPERIORITY_OR_OTHER||Risk Difference (Percentage)|0.1||||0.7348||95.0|-0.7|1.0|||Kaplan Meier weighted estimates|||RD at 6 months vs. Warfarin for Proportion of patients who died from any cause. Point estimate and 95% CI for the overall RD obtained based on the KM estimates at 6 months (180 days) after adjusting for the stratification factors active cancer at baseline and symptomatic PE at baseline.||1.0|-0.7|0.7348
72398904|NCT03060447|144304021|SUPERIORITY|||||||0.6171|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||CD69+CD56dimCD16neg, Dose 10: Day 14||||0.6171
72398905|NCT03060447|144304021|SUPERIORITY|||||||0.0677|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||CD69+CD56brCD16dim, Baseline||||0.0677
72398906|NCT03060447|144304021|SUPERIORITY|||||||0.4712|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||CD69+CD56brCD16dim, Dose 4: Day 1||||0.4712
72398907|NCT03060447|144304021|SUPERIORITY|||||||0.6889|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||CD69+CD56brCD16dim, Dose 4: Day 2||||0.6889
72398908|NCT03060447|144304021|SUPERIORITY|||||||0.1437|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||CD69+CD56brCD16dim, Dose 4: Day 4||||0.1437
72398909|NCT03060447|144304021|SUPERIORITY|||||||0.7491|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||CD69+CD56brCD16dim, Dose 6: Day 1||||0.7491
72398910|NCT03060447|144304021|SUPERIORITY|||||||0.07|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||CD69+CD56brCD16dim, Dose 6: Day 4||||0.0700
72398911|NCT03060447|144304021|SUPERIORITY|||||||0.7656|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||CD69+CD56brCD16dim, Dose 10: Day 1||||0.7656
72398912|NCT03060447|144304021|SUPERIORITY|||||||0.1752|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||CD69+CD56brCD16dim, Dose 10: Day 2||||0.1752
72398913|NCT03060447|144304021|SUPERIORITY|||||||0.07|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||CD69+CD56brCD16dim, Dose 10: Day 4||||0.0700
72398914|NCT03060447|144304021|SUPERIORITY|CD69+CD56brCD16dim, Dose 10: Day 14||||||0.2246|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||||||0.2246
72398915|NCT00778700|144304027|SUPERIORITY||Least Squares (LS) Mean Difference|-1.18|STANDARD_ERROR_OF_MEAN|0.406||0.0041|TWO_SIDED|90.0|-1.85|-0.51|||ANCOVA|The ANCOVA model included treatment as the main factor and Baseline score as the covariate.||||-0.51|-1.85|0.0041
72398916|NCT00778700|144304027|SUPERIORITY||LS Mean Difference|-1.4|STANDARD_ERROR_OF_MEAN|0.408||0.0007|TWO_SIDED|90.0|-2.08|-0.73|||ANCOVA|The ANCOVA model included treatment as the main factor and Baseline score as the covariate.||||-0.73|-2.08|0.0007
72398917|NCT00778700|144304027|SUPERIORITY||LS Mean Difference|-1.21|STANDARD_ERROR_OF_MEAN|0.407||0.0035|TWO_SIDED|90.0|-1.88|-0.53|||ANCOVA|The ANCOVA model included treatment as the main factor and Baseline score as the covariate.||||-0.53|-1.88|0.0035
72398918|NCT00527943|144304063|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.92||||0.072|TWO_SIDED|95.0|0.85|1.01|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio \<1 would indicate a lower hazard associated with vorapaxar relative to placebo.|||1.01|0.85|0.072
72398919|NCT00527943|144304064|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.89||||0.018|TWO_SIDED|95.0|0.81|0.98|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio \<1 would indicate a lower hazard associated with vorapaxar relative to placebo.|||0.98|0.81|0.018
72398920|NCT00527943|144304065|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.36|||<|0.001|TWO_SIDED|95.0|1.18|1.57|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio \<1 would indicate a lower hazard associated with vorapaxar relative to placebo.|||1.57|1.18|<0.001
72475541|NCT00422812|144476489|SUPERIORITY|||||||0.0007||||||Overall effect (0-4 hr) for TREATMENT by Log-rank p-value|Log Rank|There was no adjustment for multiple comparisons.||||||0.0007
72475542|NCT00422812|144476489|SUPERIORITY|||||||0.0008|||||||Log Rank|No adjustments were made for multiple comparisons||||||0.0008
72398921|NCT00527943|144304066|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.41|||<|0.001|TWO_SIDED|95.0|1.29|1.54|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio \<1 would indicate a lower hazard associated with vorapaxar relative to placebo.|||1.54|1.29|<0.001
72398922|NCT00527943|144304067|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.91||||0.038|TWO_SIDED|95.0|0.84|1.0|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio \<1 would indicate a lower hazard associated with vorapaxar relative to placebo.|||1.00|0.84|0.038
72398923|NCT00527943|144304068|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.9||||0.027|TWO_SIDED|95.0|0.81|0.99|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio \<1 would indicate a lower hazard associated with vorapaxar relative to placebo.|||0.99|0.81|0.027
72398924|NCT00527943|144304069|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.94||||0.174|TWO_SIDED|95.0|0.87|1.03|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio \<1 would indicate a lower hazard associated with vorapaxar relative to placebo.|||1.03|0.87|0.174
72398925|NCT00527943|144304070|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.93||||0.108|TWO_SIDED|95.0|0.86|1.02|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio \<1 would indicate a lower hazard associated with vorapaxar relative to placebo.|||1.02|0.86|0.108
72398926|NCT00527943|144304071|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.0||||0.963|TWO_SIDED|95.0|0.83|1.22|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio \<1 would indicate a lower hazard associated with vorapaxar relative to placebo.|||1.22|0.83|0.963
72398927|NCT00527943|144304072|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.88||||0.021|TWO_SIDED|95.0|0.79|0.98|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio \<1 would indicate a lower hazard associated with vorapaxar relative to placebo.|||0.98|0.79|0.021
72398928|NCT00527943|144304073|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.14||||0.418|TWO_SIDED|95.0|0.83|1.58|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio \<1 would indicate a lower hazard associated with vorapaxar relative to placebo.|||1.58|0.83|0.418
72398929|NCT00527943|144304074|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.07||||0.493|TWO_SIDED|95.0|0.88|1.31|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio \<1 would indicate a lower hazard associated with vorapaxar relative to placebo.|||1.31|0.88|0.493
72507601|NCT01651260|144546859|SUPERIORITY_OR_OTHER||upper probability of failure|0.05||||||||||Minimum sample size of 60 subjects was required based on the ability of the device to perform at an observed level of non-failure equivalent to an expected upper probability of failure not to exceed 5%.|||Minimum sample size of 60 subjects was required based on the ability of the device to perform at an observed level of non-failure equivalent to an expected upper probability of failure not to exceed 5%.|||||
72507602|NCT01605396|144546999|SUPERIORITY||Hazard Ratio (HR)|1.18||||0.565|TWO_SIDED|80.0|0.81|1.72|||Regression, Cox|||Hazard ratio (HR) and p-value for treatment difference based on Cox regression model with Efron tie handling for treatment comparison (Ridaforolimus + Dalotuzumab + Exemestane arm versus Ridaforolimus + Exemestane arm).||1.72|0.81|0.565
72507603|NCT01605396|144547001|OTHER||Difference of Percentages|-10.0||||0.267|TWO_SIDED|95.0|-27.8|8.0|||Miettinen and Nurminen's Method|||Miettinen and Nurminen's method was used to compare ORR between the two treatment arms (Ridaforolimus + Dalotuzumab + Exemestane arm versus Ridaforolimus + Exemestane arm), and to calculate a p-value and 95% confidence interval (CI) for the difference in response rates.||8.0|-27.8|0.267
72507604|NCT01605396|144547002|OTHER||Hazard Ratio (HR)|1.38||||0.562|TWO_SIDED|95.0|0.46|4.13|||Regression, Cox|||HR and p-value for treatment difference based on Cox regression model with Efron tie handling for treatment comparison (Ridaforolimus + Dalotuzumab + Exemestane arm versus Ridaforolimus + Exemestane arm).||4.13|0.46|0.562
72507605|NCT01663740|144547005|SUPERIORITY_OR_OTHER||Mean Difference|-40.166|STANDARD_ERROR_OF_MEAN|14.1387||0.0075|TWO_SIDED|95.0|-68.869|-11.463|||Mixed Models Analysis|Model adjusted for Cohort,visit,Cohort by visit interaction,baseline sperm density,age,\& duration of pre-transplant dialysis as explanatory variables.|Change in sperm density from Baseline to EOT|||-11.463|-68.869|0.0075
72507606|NCT01663740|144547006|SUPERIORITY_OR_OTHER||Mean Difference|1.758|STANDARD_ERROR_OF_MEAN|2.646||0.5109|TWO_SIDED|95.0|-3.619|7.135|||Mixed Models Analysis|Model adjusted for Cohort,visit,Cohort by visit interaction,baseline TUNEL score,age,\& duration of pre-transplant dialysis as explanatory variables.|Change in TUNEL score from Baseline to EOT|||7.135|-3.619|0.5109
72398930|NCT00527943|144304075|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.05||||0.515|TWO_SIDED|95.0|0.9|1.23|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio \<1 would indicate a lower hazard associated with vorapaxar relative to placebo.|||1.23|0.90|0.515
72623151|NCT04023045|144776854|OTHER||||||||||||||||||Descriptive analyses (mean and standard deviation) were used to compare the Habitual condition to the Assist-Knee conditions.|||
72398931|NCT00527943|144304076|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.93||||0.606|TWO_SIDED|95.0|0.7|1.23|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio \<1 would indicate a lower hazard associated with vorapaxar relative to placebo.|||1.23|0.70|0.606
72398932|NCT00531817|144304201|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|18.85|||<|0.0001|TWO_SIDED|95.0|12.29|25.42||The p-value was not adjusted. The primary objective was a single comparison with an a priori threshold of 0.05 for statistical significance.|Fisher Exact|||Power calculation: Assuming placebo+DMARDs response rate of 15% and tocilizumab 8 mg/kg+DMARDs response rate of 28% based on previous trials, a sample size of 570 patients (2:1 ratio, tocilizumab+DMARDs n=380 and placebo+DMARDs n=190) will provide \> 90% power to detect a difference between 2 treatment arms with 5% Type I error with a 2-sided Fisher's exact test. Null Hypothesis: The percentage of patients responding in each treatment group (tocilizumab+DMARDs vs placebo+ DMARDs) is the same.||25.42|12.29|<0.0001
72398933|NCT03338855|144304211|SUPERIORITY||Least Square (LS) Mean Difference|-1.068|STANDARD_ERROR_OF_MEAN|1.014||0.3047|TWO_SIDED|95.0|-3.183|1.047|||Linear Mixed Effects Model|A linear mixed model with treatment group, treatment sequence, and period as fixed effects and patient as random effect.||Comparison of delta RD (basal vs high insulin) between dapagliflozin and placebo after 5 weeks of treatment was performed using a random effects analysis of variance model.||1.047|-3.183|0.3047
72398934|NCT03338855|144304212|SUPERIORITY||LS Mean Difference|-1.705|STANDARD_ERROR_OF_MEAN|0.517||0.0036|TWO_SIDED|95.0|-2.784|-0.625|||Linear Mixed Effects Model|A linear mixed model with treatment group, treatment sequence, and period as fixed effects and patient as random effect.||Comparison of delta EGP (basal vs low insulin) between dapagliflozin and placebo after 5 weeks of treatment was performed using a random effects analysis of variance model.||-0.625|-2.784|0.0036
72398935|NCT03338855|144304212|SUPERIORITY||LS Mean Difference|-2.292|STANDARD_ERROR_OF_MEAN|0.409|<|0.0001|TWO_SIDED|95.0|-3.146|-1.438|||Linear Mixed Effects Model|A linear mixed model with treatment group, treatment sequence, and period as fixed effects and patient as random effect.||Comparison of delta EGP (basal vs high insulin) between dapagliflozin and placebo after 5 weeks of treatment was performed using a random effects analysis of variance model.||-1.438|-3.146|<0.0001
72398936|NCT03338855|144304213|SUPERIORITY||LS Mean Difference|0.012|STANDARD_ERROR_OF_MEAN|0.009||0.1842|TWO_SIDED|95.0|-0.006|0.03|||Linear Mixed Effects Model|A linear mixed model with treatment group, treatment sequence, and period as fixed effects and patient as random effect.||Comparison of delta RER (basal vs high insulin) between dapagliflozin and placebo after 5 weeks of treatment was performed using a random effects analysis of variance model.||0.030|-0.006|0.1842
72398937|NCT03338855|144304214|SUPERIORITY||LS Mean Difference|-0.023|STANDARD_ERROR_OF_MEAN|0.005||0.0001|TWO_SIDED|95.0|-0.033|-0.013|||Linear Mixed Effects Model|A linear mixed model with treatment group, treatment sequence, and period as fixed effects and patient as random effect.||Comparison of 24-hour RER between dapagliflozin and placebo after 5 weeks of treatment was performed using a random effects analysis of variance model.||-0.013|-0.033|0.0001
72398938|NCT03338855|144304215|SUPERIORITY||LS Mean Difference|-0.109|STANDARD_ERROR_OF_MEAN|0.065||0.1095|TWO_SIDED|95.0|-0.245|0.027|||Linear Mixed Effects Model|A linear mixed model with treatment group, treatment sequence, and period as fixed effects and patient as random effect.||Comparison of energy expenditure between dapagliflozin and placebo after 5 weeks of treatment was performed using a random effects analysis of variance model.||0.027|-0.245|0.1095
72398939|NCT03338855|144304216|SUPERIORITY||LS Mean Difference|-246.7|STANDARD_ERROR_OF_MEAN|464.3||0.6005|TWO_SIDED|95.0|-1209.5|716.2|||Linear Mixed Effects Model||A linear mixed model with treatment group, treatment sequence, and period as fixed effects and patient as random effect.|Comparison of fat mass between dapagliflozin and placebo after 5 weeks of treatment was performed using a random effects analysis of variance model.||716.2|-1209.5|0.6005
72398940|NCT03338855|144304216|SUPERIORITY||LS Mean Difference|-666.5|STANDARD_ERROR_OF_MEAN|301.1||0.0376|TWO_SIDED|95.0|-1291.0|-41.9|||Linear Mixed Effects Model|A linear mixed model with treatment group, treatment sequence, and period as fixed effects and patient as random effect.||Comparison of lean mass between dapagliflozin and placebo after 5 weeks of treatment was performed using a random effects analysis of variance model.||-41.9|-1291.0|0.0376
72398941|NCT03338855|144304217|SUPERIORITY||LS Mean Difference|-1.256|STANDARD_ERROR_OF_MEAN|0.289||0.0003|TWO_SIDED|95.0|-1.854|-0.657|||Linear Mixed Effects Model||A linear mixed model with treatment group, treatment sequence, and period as fixed effects and patient as random effect.|Comparison of total mass between dapagliflozin and placebo after 5 weeks of treatment was performed using a random effects analysis of variance model.||-0.657|-1.854|0.0003
72507607|NCT01663740|144547006|SUPERIORITY_OR_OTHER||Mean Difference|-1.051|STANDARD_ERROR_OF_MEAN|3.2058||0.7449|TWO_SIDED|95.0|-7.566|5.464|||Mixed Models Analysis|Model adjusted for Cohort,visit,Cohort by visit interaction,baseline TUNEL score,age,\& duration of pre-transplant dialysis as explanatory variables.|Change in TUNEL score from Baseline to end of FU|||5.464|-7.566|0.7449
72398942|NCT03338855|144304218|SUPERIORITY||LS Mean Difference|-244.301|STANDARD_ERROR_OF_MEAN|165.168||0.1555|TWO_SIDED|95.0|-590.002|101.401|||Linear Mixed Effects Model||A linear mixed model with treatment group, treatment sequence, and period as fixed effects and patient as random effect.|Comparison of FGF21 AUC between dapagliflozin and placebo after 5 weeks of treatment was performed using a random effects analysis of variance model.||101.401|-590.002|0.1555
72398943|NCT00056407|144304226|SUPERIORITY_OR_OTHER||Relative Risk Reduction|23.3|||<|0.0001||95.0|15.6|30.3||The p value is given is for the overall assessment.|Mantel-Cox||Estimation data given are for the overall assessment.|||30.3|15.6|<0.0001
72398944|NCT00056407|144304227|SUPERIORITY_OR_OTHER||Relative Risk Reduction|23.1|||<|0.0001||95.0|15.5|30.0||The p value is given is for the overall assessment.|Mantel-Cox||Estimation data are given are for the overall assessment.|||30.0|15.5|<0.0001
72398945|NCT00056407|144304228|SUPERIORITY_OR_OTHER||Relative Risk Reduction|22.8|||<|0.0001||95.0|15.2|29.8||The p value is given for the overall assessment.|Mantel-Cox||Estimation data are given for the overall assessment.|||29.8|15.2|<0.0001
72398946|NCT00056407|144304251|SUPERIORITY_OR_OTHER||Difference in adjusted means|18.8|||<|0.001||95.0|17.3|20.4|||general linear model, t-test||The adjusted mean difference was calculated as the difference between the adjusted means (-6.1 and 12.7) for the placebo and Dutasteride arms, respectively.|||20.4|17.3|<0.001
72475543|NCT00422812|144476489|SUPERIORITY|||||||0.0008||||||No adjustments were made for multiple comparisons|Log Rank|||||||0.0008
72475544|NCT00422812|144476489|SUPERIORITY|||||||0.0003||||||No adjustments were made for multiple comparisons|Log Rank|||||||0.0003
72475545|NCT01397422|144476490|SUPERIORITY||Least Squares Mean Difference|-11.3||||0.0051|TWO_SIDED|95.0|-19.1|-3.5|||ANCOVA|Change from baseline is a dependent variable, treatment group is a factor, and the baseline value is a covariate.||20 subjects per treatment arm provided 80% power using a 2-sided 2-sample test at 5% significance. The null hypothesis for the primary endpoint was that the response of the ADS-5102 340 mg group was equal to that of the placebo group.||-3.5|-19.1|0.0051
72475546|NCT01397422|144476490|SUPERIORITY||Least Squares Mean Difference|-10.0||||0.0131|TWO_SIDED|95.0|-17.8|-2.2|||ANCOVA|||||-2.2|-17.8|0.0131
72475547|NCT01397422|144476490|SUPERIORITY||Least Squares Mean Difference|-5.6||||0.1595|TWO_SIDED|95.0|-13.4|2.2|||ANCOVA|||||2.2|-13.4|0.1595
72475548|NCT01397422|144476491|SUPERIORITY||Least Squares Mean Difference|-0.3||||0.4314|TWO_SIDED|95.0|-1.1|0.5|||ANCOVA|||||0.5|-1.1|0.4314
72507608|NCT01663740|144547007|SUPERIORITY_OR_OTHER||Mean Difference|2.869|STANDARD_ERROR_OF_MEAN|3.2934||0.394|TWO_SIDED|95.0|-4.001|9.739|||Mixed Models Analysis|Model adjusted for Cohort,visit,Cohort by visit interaction,baseline TUNEL score,age,\& duration of pre-transplant dialysis as explanatory variables.|Change in TUNEL score from EOT to end of FU|||9.739|-4.001|0.3940
72507609|NCT01663740|144547008|SUPERIORITY_OR_OTHER||Mean Difference|0.155|STANDARD_ERROR_OF_MEAN|0.3687||0.6773|TWO_SIDED|95.0|-0.594|0.903|||Mixed Models Analysis|Model adjusted for Cohort,visit,Cohort by visit interaction,baseline semen volume,age,\& duration of pre-transplant dialysis as explanatory variables.|Change in seminal volume from Basline to EOT|||0.903|-0.594|0.6773
72507610|NCT01663740|144547008|SUPERIORITY_OR_OTHER||Mean Difference|-0.128|STANDARD_ERROR_OF_MEAN|0.3343||0.7046|TWO_SIDED|95.0|-0.806|0.551|||Mixed Models Analysis|Model adjusted for Cohort,visit,Cohort by visit interaction,baseline semen volume,age,\& duration of pre-transplant dialysis as explanatory variables.|Change in seminal volume from Baseline to end of FU|||0.551|-0.806|0.7046
72507611|NCT01663740|144547009|SUPERIORITY_OR_OTHER||Mean Difference|-0.128|STANDARD_ERROR_OF_MEAN|0.3684||0.7323|TWO_SIDED|95.0|-0.888|0.633|||Mixed Models Analysis|Model adjusted for Cohort,visit,Cohort by visit interaction,baseline semen volume,age,\& duration of pre-transplant dialysis as explanatory variables.|Change in seminal volume from EOT to end of FU|||0.633|-0.888|0.7323
72507612|NCT01663740|144547010|SUPERIORITY_OR_OTHER||Mean Difference|51.267|STANDARD_ERROR_OF_MEAN|36.6869||0.1756|TWO_SIDED|95.0|-24.626|127.159|||Mixed Models Analysis|Model adjusted for Cohort,visit,Cohort by visit interaction,baseline sperm density,age,\& duration of pre-transplant dialysis as explanatory variables.|Change in sperm density from EOT to end of FU|||127.159|-24.626|0.1756
72475549|NCT01397422|144476491|SUPERIORITY||Least Squares Mean Difference|0.3||||0.5223|TWO_SIDED|95.0|-0.5|1.0|||ANCOVA|||||1.0|-0.5|0.5223
72475550|NCT01397422|144476491|SUPERIORITY||Least Squares Mean Difference|0.2||||0.6298|TWO_SIDED|95.0|-0.6|1.0|||ANCOVA|Change from baseline is a dependent variable, treatment group is a factor, baseline value is a covariate||||1.0|-0.6|0.6298
72475551|NCT01397422|144476492|SUPERIORITY||Least Squares Mean Difference|-5.2||||0.0038|TWO_SIDED|95.0|-8.7|-1.7|||ANCOVA|||||-1.7|-8.7|0.0038
72475552|NCT01397422|144476492|SUPERIORITY||Least Squares Mean Difference|-6.4||||0.0004|TWO_SIDED|95.0|-9.8|-2.9|||ANCOVA|||||-2.9|-9.8|0.0004
72475553|NCT01397422|144476492|SUPERIORITY||Least Squares Mean Difference|-2.5||||0.1469|TWO_SIDED|95.0|-6.0|0.9|||ANCOVA|Change from baseline is a dependent variable, treatment group is a factor, and the baseline value is a covariate.||||0.9|-6.0|0.1469
72475554|NCT01397422|144476493|SUPERIORITY||Least Squares Mean Difference|3.0||||0.0078|TWO_SIDED|95.0|0.8|5.2|||ANCOVA|||||5.2|0.8|0.0078
72475555|NCT01397422|144476493|SUPERIORITY||Least Squares Mean Difference|2.7||||0.0179|TWO_SIDED|95.0|0.5|5.0|||ANCOVA|||||5.0|0.5|0.0179
72475556|NCT01397422|144476493|SUPERIORITY||Least Squares Mean Difference|3.3||||0.004|TWO_SIDED|95.0|1.1|5.5|||ANCOVA|Change from baseline is a dependent variable, treatment group is a factor, and the baseline value is a covariate||||5.5|1.1|0.0040
72475557|NCT01397422|144476494|SUPERIORITY||Least Squares Mean Difference|-2.2||||0.6355|TWO_SIDED|95.0|-11.2|6.9|||ANCOVA|||||6.9|-11.2|0.6355
72475558|NCT01397422|144476494|SUPERIORITY||Least Squares Mean Difference|1.7||||0.7053|TWO_SIDED|95.0|-7.2|10.6|||ANCOVA|||||10.6|-7.2|0.7053
72475559|NCT01397422|144476494|SUPERIORITY||Least Squares Mean Difference|1.2||||0.7862|TWO_SIDED|95.0|-7.7|10.1|||ANCOVA|Change from baseline is a dependent variable, treatment group is a factor, and the baseline value is a covariate||||10.1|-7.7|0.7862
72475560|NCT01397422|144476495|SUPERIORITY|||||||0.0036|||||||Cochran-Mantel-Haenszel|||||||0.0036
72475561|NCT01397422|144476495|SUPERIORITY|||||||0.2158|||||||Cochran-Mantel-Haenszel|||||||0.2158
72475562|NCT01397422|144476495|SUPERIORITY|||||||0.1042|||||||Cochran-Mantel-Haenszel|Equally spaced scores||||||0.1042
72475563|NCT00513305|144476516|SUPERIORITY_OR_OTHER|||||||0.425|TWO_SIDED|95.0||||The p-value is from the Pearson chi-square test for testing the equality of two binomial proportions, assuming normal approximation of the binomial proportions.|Chi-squared|There were no adjustments for covariates. Since the primary endpoint was prespecified, no adjustment for multiplicity of endpoints was introduced||The hypothesis of equal complete remission rates between the two treatment groups was tested using a 2-sided, normal approximation to the difference in binomial proportions test with two-sided alpha equal to 0.05.||||0.425
72475564|NCT00513305|144476517|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.027||||0.829|TWO_SIDED|95.0|0.535|1.973|||Log Rank|||||1.973|0.535|0.829
72475565|NCT00513305|144476518|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|2.31||||0.527|TWO_SIDED|95.0|0.16|33.343|||Log Rank||Estimate based on Cox Proportional Hazards Model adjusting for age, Eastern Cooperative Oncology Group (ECOG) status, white blood count and presence of antecedent hematologic disorder.|||33.343|0.160|0.527
72475566|NCT00513305|144476521|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.027||||0.8289|TWO_SIDED|95.0|0.535|1.973|||Log Rank||Estimate based on Cox Proportional Hazards Model adjusting for age, Eastern Cooperative Oncology Group (ECOG) status, white blood count and presence of antecedent hematologic disorder.|||1.973|0.535|0.8289
72475567|NCT01133418|144476593|SUPERIORITY_OR_OTHER|||||||0.36||||||a priori threshold for statistical significance was .05|General Linear Model|||||||.36
72475568|NCT01133418|144476594|SUPERIORITY_OR_OTHER|||||||0.86|||||||General Linear Model|||||||.86
72398947|NCT03204305|144304254|SUPERIORITY||t-test|-2.51||||0.02|TWO_SIDED|||||p \< 0.05 for all analyses. Bonferroni corrections were made to reduce family-wise error rate.|t-test, 2 sided|Composite VT was compared using independent t-tests.||VT in the 8 volumes of interest were analyzed using linear regression model group coded encoded as a dummy variable \[1=females cannabis users; 2= female healthy controls\], age as a covariate, and VT for VOIs (ventral striatum, amygdala, putamen, cingulate, globus pallidus, insula, frontal cortex, and hippocampus) as dependent variables, followed by post hoc Tukey's HSD between between groups.||||0.02
72398948|NCT03204305|144304254|SUPERIORITY||t-test|-2.36||||0.03|TWO_SIDED||||||t-test, 2 sided|||||||0.03
72398949|NCT03204305|144304254|SUPERIORITY||t-test|-2.35||||0.03|TWO_SIDED||||||t-test, 2 sided|||||||0.03
72398950|NCT03204305|144304254|SUPERIORITY||t-test|-2.23||||0.04|TWO_SIDED||||||t-test, 2 sided|||||||0.04
72398951|NCT03204305|144304255|SUPERIORITY||t test|-2.52||||0.03|TWO_SIDED||||||t-test, 2 sided|||||||0.03
72475569|NCT01133418|144476595|SUPERIORITY_OR_OTHER|||||||0.79|||||||General Linear Model|||||||.79
72398952|NCT02335099|144304256|SUPERIORITY||Odds Ratio (OR)|3.77||||0.32|TWO_SIDED|95.0|0.27|217.52|||Fisher Exact|||||217.52|0.27|0.32
72398953|NCT02335099|144304257|SUPERIORITY||Cox Proportional Hazard|0.86||||0.82|TWO_SIDED|95.0|0.23|3.2|||Log Rank|||||3.20|0.23|0.82
72398954|NCT02461225|144304258|SUPERIORITY||||||<|0.0005|||||||Fisher Exact|||||||<.0005
72475570|NCT01133418|144476596|SUPERIORITY_OR_OTHER|||||||0.77|||||||General Linear Model|||||||.77
72475571|NCT05316701|144476597|SUPERIORITY||Hazard Ratio (HR)|0.26|||<|1e-05|TWO_SIDED|95.0|0.14|0.47|||Log Rank|||Log-rank test was stratified by randomization stratification factors.||0.47|0.14|<0.00001
72475572|NCT05316701|144476598|SUPERIORITY||Hazard Ratio (HR)|0.19||||2e-05|TWO_SIDED|95.0|0.08|0.43|||Gray's test|||Gray's test was stratified by randomization stratification factors.||0.43|0.08|0.00002
72475573|NCT05316701|144476599|SUPERIORITY||Hazard Ratio (HR)|0.49||||0.11823|TWO_SIDED|95.0|0.2|1.22|||Log Rank|||Log-rank test was stratified by randomization stratification factors.||1.22|0.20|0.11823
72475574|NCT05316701|144476600|SUPERIORITY||Hazard Ratio (HR)|0.37||||3e-05|TWO_SIDED|95.0|0.23|0.6|||Log Rank|||Log-rank test was stratified by randomization stratification factors.||0.60|0.23|0.00003
72398955|NCT02461225|144304259|SUPERIORITY||||||<|0.0001|||||||ANOVA|||||||<0.0001
72475575|NCT04696653|144476601|SUPERIORITY||Mean Difference (Net)|0.0|||||TWO_SIDED|95.0|-0.2|0.1||||||||0.1|-0.2|
72475576|NCT04696653|144476602|SUPERIORITY||Mean Difference (Net)|1.0|||||TWO_SIDED|95.0|0.2|1.8||||||hypertension||1.8|0.2|
72475577|NCT04696653|144476602|SUPERIORITY||Mean Difference (Net)|1.1|||||TWO_SIDED|95.0|0.0|2.1||||||dyslipidemia||2.1|0.0|
72475578|NCT04696653|144476602|SUPERIORITY||Mean Difference (Net)|1.0|||||TWO_SIDED|95.0|0.1|2.0||||||diabetes||2.0|0.1|
72475579|NCT04696653|144476603|SUPERIORITY||Mean Difference (Net)|-0.2|||||TWO_SIDED|95.0|-0.6|0.1||||||Evidenced based practice||0.1|-0.6|
72475580|NCT04696653|144476603|SUPERIORITY||Mean Difference (Net)|-0.2|||||TWO_SIDED|95.0|-0.6|0.1||||||CUSP strategy||0.1|-0.6|
72475581|NCT04696653|144476604|SUPERIORITY||Mean Difference (Net)|-0.2|||||TWO_SIDED|95.0|-0.6|0.2||||||CUSP strategy||0.2|-0.6|
72398956|NCT00484939|144304260|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Log Rank|||||||<0.001
72398957|NCT00484939|144304261|SUPERIORITY_OR_OTHER|||||||0.029|||||||Fisher Exact|||This statistical analysis compared the number of responders in the 2 treatment groups. A responder was defined as any participant with a best overall response of complete response or partial response. There were 28 responders in the bevacizumab + capecitabine group and 14 responders in the capecitabine group.||||0.029
72398958|NCT00484939|144304264|SUPERIORITY_OR_OTHER|||||||0.13|||||||Log Rank|||||||0.130
72398959|NCT00735787|144304269|SUPERIORITY_OR_OTHER|||||||0.014||95.0|||||Fisher Exact|||The primary null hypothesis for this study was that there was no difference in the proportion of subjects that achieved PGA clear or almost clear at Week 16 between the adalimumab and placebo groups. Analysis was done using a two-sided Fisher's exact test at alpha level=0.05.||||0.014
72398960|NCT01566461|144304302|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||z-test|||||||<0.001
72398961|NCT01566461|144304303|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Chi-squared|||||||<0.001
72475582|NCT04696653|144476604|SUPERIORITY||Mean Difference (Net)|-0.2|||||TWO_SIDED|95.0|-0.5|0.1||||||Evidenced based practice||0.1|-0.5|
72475583|NCT04696653|144476605|SUPERIORITY||Mean Difference (Net)|-0.2|||||TWO_SIDED|95.0|-0.5|0.1||||||evidenced based practice||0.1|-0.5|
72475584|NCT04696653|144476605|SUPERIORITY||Mean Difference (Net)|-0.1|||||TWO_SIDED|95.0|-0.5|0.2||||||CUSP strategy||0.2|-0.5|
72475585|NCT04696653|144476606|SUPERIORITY||Odds Ratio (OR)|1.4|||||TWO_SIDED|95.0|0.9|2.2||||||||2.2|0.9|
72475586|NCT04696653|144476607|SUPERIORITY||Odds Ratio (OR)|1.4|||||TWO_SIDED|95.0|1.1|1.9||||||||1.9|1.1|
72475587|NCT04696653|144476608|SUPERIORITY||Odds Ratio (OR)|1.0|||||TWO_SIDED|95.0|0.7|1.4||||||||1.4|0.7|
72475588|NCT04696653|144476609|SUPERIORITY||Odds Ratio (OR)|1.8|||||TWO_SIDED|95.0|1.2|2.6||||||||2.6|1.2|
72475589|NCT04696653|144476614|SUPERIORITY||Odds Ratio (OR)|1.2|||||TWO_SIDED|95.0|1.0|1.6||||||||1.6|1.0|
72475590|NCT04696653|144476615|SUPERIORITY||Mean Difference (Net)|-0.1|||||TWO_SIDED|95.0|-0.2|0.1||||||||0.1|-0.2|
72475591|NCT04696653|144476616|SUPERIORITY||Mean Difference (Net)|0.0|||||TWO_SIDED|95.0|-0.2|0.2||||||||0.2|-0.2|
72475592|NCT04696653|144476617|SUPERIORITY||Mean Difference (Net)|0.0|||||TWO_SIDED|95.0|-0.2|0.1||||||||0.1|-0.2|
72475593|NCT04696653|144476618|SUPERIORITY||Mean Difference (Net)|0.0|||||TWO_SIDED|95.0|-0.2|0.2||||||||0.2|-0.2|
72475594|NCT04696653|144476619|SUPERIORITY||Mean Difference (Net)|-0.1|||||TWO_SIDED|95.0|-0.3|0.0||||||||0.0|-0.3|
72475595|NCT04696653|144476620|SUPERIORITY||Mean Difference (Net)|-0.2|||||TWO_SIDED|95.0|-0.3|0.0||||||||0.0|-0.3|
72475596|NCT04696653|144476621|SUPERIORITY||Mean Difference (Net)|0.1|||||TWO_SIDED|95.0|-0.1|0.3||||||||0.3|-0.1|
72475597|NCT04696653|144476622|SUPERIORITY||Mean Difference (Net)|0.1|||||TWO_SIDED|95.0|-0.1|0.2||||||||0.2|-0.1|
72475598|NCT04696653|144476623|SUPERIORITY||Mean Difference (Net)|0.0|||||TWO_SIDED|95.0|-0.2|0.2||||||||0.2|-0.2|
72475599|NCT04696653|144476624|SUPERIORITY||Mean Difference (Net)|-0.2|||||TWO_SIDED|95.0|-0.4|0.0||||||||0.0|-0.4|
72475600|NCT04696653|144476625|SUPERIORITY||Odds Ratio (OR)|1.8|||||TWO_SIDED|95.0|1.0|3.3||||||||3.3|1.0|
72623152|NCT04023045|144776855|OTHER||||||||||||||||||Descriptive analyses (mean and standard deviation) were used to compare the Habitual condition to the Assist-Knee conditions.|||
72623153|NCT04023045|144776856|OTHER||||||||||||||||||Descriptive analyses (mean and standard deviation) were used to compare the Habitual condition to the Assist-Knee conditions.|||
72398962|NCT01566461|144304304|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Chi-squared|||||||<0.001
72398963|NCT01566461|144304305|SUPERIORITY_OR_OTHER|||||||0.926|TWO_SIDED||||||Chi-squared|||||||0.926
72475601|NCT04362189|144476631|SUPERIORITY||Slope|-1.93|||||TWO_SIDED||||||||Slope represents beta coefficient for arm \* time interaction.|Analyses relied on Bayesian inference for test of superiority via generalized linear mixed model.||||
72475602|NCT04362189|144476632|SUPERIORITY||Slope|-1.31|||||TWO_SIDED||||||||Slope represents beta coefficient for arm \* time interaction.|||||
72475603|NCT04362189|144476633|SUPERIORITY||Slope|1.36|||||TWO_SIDED||||||||Slope represents beta coefficient for arm \* time interaction.|Analyses relied on Bayesian inference for test of superiority via generalized linear mixed model.||||
72475604|NCT04362189|144476634|SUPERIORITY||Slope|0.23|||||TWO_SIDED||||||||Slope represents beta coefficient for arm \* time interaction.|Analyses relied on Bayesian inference for test of superiority via generalized linear mixed model.||||
72475605|NCT04362189|144476635|SUPERIORITY||Slope|-0.15|||||TWO_SIDED||||||||Slope represents beta coefficient for arm \* time interaction.|Analyses relied on Bayesian inference for test of superiority via generalized linear mixed model.||||
72475606|NCT04362189|144476636|SUPERIORITY||Odds Ratio (OR)|0.2|||||TWO_SIDED||||||||HB-adMSCs represents Numerator and Placebo represents Denominator.|Analyses relied on Bayesian inference for test of superiority via generalized linear mixed model.||||
72475607|NCT04362189|144476643|SUPERIORITY||Slope|-0.17|||||TWO_SIDED||||||||Slope represents beta coefficient for arm \* time interaction.|Analyses relied on Bayesian inference for test of superiority via generalized linear mixed model.||||
72475608|NCT04362189|144476644|SUPERIORITY||Slope|0.55|||||TWO_SIDED||||||||Slope represents beta coefficient for arm \* time interaction.|Analyses relied on Bayesian inference for test of superiority via generalized linear mixed model.||||
72475609|NCT04362189|144476645|SUPERIORITY||Slope|0.26|||||TWO_SIDED||||||||Slope represents beta coefficient for arm \* time interaction.|Analyses relied on Bayesian inference for test of superiority via generalized linear mixed model.||||
72475610|NCT04362189|144476646|SUPERIORITY||Slope|0.81|||||TWO_SIDED||||||||Slope represents beta coefficient for arm \* time interaction.|Analyses relied on Bayesian inference for test of superiority via generalized linear mixed model.||||
72475611|NCT04348435|144476694|SUPERIORITY||Mean Difference (Net)|0.253|STANDARD_ERROR_OF_MEAN|0.49||0.6113|TWO_SIDED|95.0|||||ANCOVA|||||||0.6113
72475612|NCT04348435|144476694|SUPERIORITY||Mean Difference (Net)|-0.434|STANDARD_ERROR_OF_MEAN|0.638||0.5039|TWO_SIDED|95.0|||||ANCOVA|||||||0.5039
72475613|NCT04348435|144476694|SUPERIORITY||Mean Difference (Net)|0.077|STANDARD_ERROR_OF_MEAN|0.555||0.8903|TWO_SIDED|95.0|||||ANCOVA|||||||0.8903
72475614|NCT04348435|144476695|SUPERIORITY||Mean Difference (Net)|-0.247|STANDARD_ERROR_OF_MEAN|1.056||0.8171|TWO_SIDED|95.0|||||ANCOVA|||||||0.8171
72475615|NCT04348435|144476695|SUPERIORITY||Mean Difference (Net)|-0.913|STANDARD_ERROR_OF_MEAN|1.342||0.5034|TWO_SIDED|95.0|||||ANCOVA|||||||0.5034
72475616|NCT04348435|144476695|SUPERIORITY||Mean Difference (Net)|0.008|STANDARD_ERROR_OF_MEAN|1.193||0.9948|TWO_SIDED|95.0|||||ANCOVA|||||||0.9948
72475617|NCT04348435|144476696|SUPERIORITY||Mean Difference (Net)|0.179|STANDARD_ERROR_OF_MEAN|0.156||0.2641|TWO_SIDED|95.0|||||ANCOVA|||||||0.2641
72475618|NCT04348435|144476696|SUPERIORITY||Mean Difference (Net)|-0.045|STANDARD_ERROR_OF_MEAN|0.198||0.822|TWO_SIDED|95.0|||||ANCOVA|||||||0.8220
72475619|NCT04348435|144476696|SUPERIORITY||Median Difference (Net)|0.178|STANDARD_ERROR_OF_MEAN|0.171||0.3097|TWO_SIDED|95.0|||||ANCOVA|||||||0.3097
72475620|NCT04348435|144476697|SUPERIORITY||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|0.07||1|TWO_SIDED|95.0|||||ANCOVA|||||||1.000
72475621|NCT04348435|144476697|SUPERIORITY||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|0.087||1|TWO_SIDED|95.0|||||ANCOVA|||||||1.000
72475622|NCT04348435|144476697|SUPERIORITY||Mean Difference (Net)|0.112|STANDARD_ERROR_OF_MEAN|0.079||0.1713|TWO_SIDED|95.0|||||ANCOVA|||||||0.1713
72475623|NCT04348435|144476698|SUPERIORITY||Mean Difference (Net)|0.08|STANDARD_ERROR_OF_MEAN|0.091||0.3868|TWO_SIDED|95.0|||||ANCOVA|||||||0.3868
72475624|NCT04348435|144476698|SUPERIORITY||Mean Difference (Net)|-0.008|STANDARD_ERROR_OF_MEAN|0.115||0.9429|TWO_SIDED|95.0|||||ANCOVA|||||||0.9429
72475625|NCT04348435|144476698|SUPERIORITY||Mean Difference (Net)|-0.008|STANDARD_ERROR_OF_MEAN|0.103||0.9362|TWO_SIDED|95.0|||||ANCOVA|||||||0.9362
72475626|NCT04348435|144476699|SUPERIORITY||Mean Difference (Net)|-0.708|STANDARD_ERROR_OF_MEAN|8.38||0.9333|TWO_SIDED|95.0|||||ANCOVA|||Average Energy/Fatigue - Treatment Contrast||||0.9333
72475627|NCT04348435|144476699|SUPERIORITY||Mean Difference (Net)|8.78|STANDARD_ERROR_OF_MEAN|9.483||0.3627|TWO_SIDED|95.0|||||ANCOVA|||Average Energy/Fatigue - Treatment Contrast||||0.3627
72475628|NCT04348435|144476699|SUPERIORITY||Mean Difference (Net)|6.282|STANDARD_ERROR_OF_MEAN|7.604||0.416|TWO_SIDED|95.0|||||ANCOVA|||Average Energy/Fatigue - Treatment Contrast||||0.4160
72475629|NCT04348435|144476699|SUPERIORITY||Mean Difference (Net)|0.52|STANDARD_ERROR_OF_MEAN|3.32||0.8768|TWO_SIDED|95.0|||||ANCOVA|||Average Social Functioning - Treatment Contrast||||0.8768
72475630|NCT04348435|144476699|SUPERIORITY||Mean Difference (Net)|-7.719|STANDARD_ERROR_OF_MEAN|4.344||0.0869|TWO_SIDED|95.0|||||ANCOVA|||Average Social Functioning - Treatment Contrast||||0.0869
72475631|NCT04348435|144476699|SUPERIORITY||Mean Difference (Net)|1.434|STANDARD_ERROR_OF_MEAN|3.514||0.6864|TWO_SIDED|95.0|||||ANCOVA|||Average Social Functioning - Treatment Contrast||||0.6864
72475632|NCT04348435|144476699|SUPERIORITY||Mean Difference (Net)|-4.12|STANDARD_ERROR_OF_MEAN|3.571||0.2587|TWO_SIDED|95.0|||||ANCOVA|||Avg. Role Limitations Due to Physical Health - Treatment Contrast||||0.2587
72475633|NCT04348435|144476699|SUPERIORITY||Mean Difference (Net)|8.417|STANDARD_ERROR_OF_MEAN|5.316||0.125|TWO_SIDED|95.0|||||ANCOVA|||Avg. Role Limitations Due to Physical Health - Treatment Contrast||||0.1250
72475634|NCT04348435|144476699|SUPERIORITY||Mean Difference (Net)|-0.104|STANDARD_ERROR_OF_MEAN|3.732||0.978|TWO_SIDED|95.0|||||ANCOVA|||Avg. Role Limitations Due to Physical Health - Treatment Contrast||||0.9780
72475635|NCT04348435|144476699|SUPERIORITY||Mean Difference (Net)|0.963|STANDARD_ERROR_OF_MEAN|5.925||0.8721|TWO_SIDED|95.0|||||ANCOVA|||Average General Health - Treatment Contrast||||0.8721
72398964|NCT01566461|144304306|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Chi-squared|||||||<0.001
72398965|NCT01566461|144304307|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Chi-squared|||||||<0.001
72398966|NCT01566461|144304308|SUPERIORITY_OR_OTHER|||||||0.859|TWO_SIDED||||||t-test, 1 sided|||||||0.859
72398967|NCT01566461|144304309|SUPERIORITY_OR_OTHER||||||>|0.999|TWO_SIDED||||||Chi-squared|||||||>0.999
72475636|NCT04348435|144476699|SUPERIORITY||Mean Difference (Net)|3.34|STANDARD_ERROR_OF_MEAN|7.735||0.6694|TWO_SIDED|95.0|||||ANCOVA|||Average General Health - Treatment Contrast||||0.6694
72475637|NCT04348435|144476699|SUPERIORITY||Mean Difference (Net)|5.498|STANDARD_ERROR_OF_MEAN|6.073||0.3733|TWO_SIDED|95.0|||||ANCOVA|||Average General Health - Treatment Contrast||||0.3733
72475638|NCT04348435|144476699|SUPERIORITY||Mean Difference (Net)|2.433|STANDARD_ERROR_OF_MEAN|4.116||0.5594|TWO_SIDED|95.0|||||ANCOVA|||Average Physical Functioning - Treatment Contrast||||0.5594
72475639|NCT04348435|144476699|SUPERIORITY||Mean Difference (Net)|6.878|STANDARD_ERROR_OF_MEAN|5.389||0.2127|TWO_SIDED|95.0|||||ANCOVA|||Average Physical Functioning - Treatment Contrast||||0.2127
72475640|NCT04348435|144476699|SUPERIORITY||Mean Difference (Net)|3.67|STANDARD_ERROR_OF_MEAN|4.303||0.4012|TWO_SIDED|95.0|||||ANCOVA|||Average Physical Functioning - Treatment Contrast||||0.4012
72475641|NCT04348435|144476699|SUPERIORITY||Mean Difference (Net)|11.678|STANDARD_ERROR_OF_MEAN|5.748||0.0521|TWO_SIDED|95.0|||||ANCOVA|||Average Pain - Treatment Contrast||||0.0521
72475642|NCT04348435|144476699|SUPERIORITY||Mean Difference (Net)|5.635|STANDARD_ERROR_OF_MEAN|7.696||0.4704|TWO_SIDED|95.0|||||ANCOVA|||Average Pain - Treatment Contrast||||0.4704
72475643|NCT04348435|144476699|SUPERIORITY||Mean Difference (Net)|12.101|STANDARD_ERROR_OF_MEAN|6.017||0.0544|TWO_SIDED|95.0|||||ANCOVA|||Average Pain - Treatment Contrast||||0.0544
72475644|NCT04348435|144476699|SUPERIORITY||Mean Difference (Net)|2.333|STANDARD_ERROR_OF_MEAN|3.888||0.5535|TWO_SIDED|95.0|||||ANCOVA|||Average Emotional Well Being - Treatment Contrast||||0.5535
72507613|NCT01663740|144547011|SUPERIORITY_OR_OTHER||Mean Difference|-10.195|STANDARD_ERROR_OF_MEAN|19.5745||0.6058|TWO_SIDED|95.0|-49.934|29.543|||Mixed Models Analysis|Model adjusted for Cohort,visit,Cohort by visit interaction,baseline sperm density,age,\& duration of pre-transplant dialysis as explanatory variables.|Change in sperm density from Baseline to end of FU|||29.543|-49.934|0.6058
72623154|NCT04023045|144776857|OTHER||||||||||||||||||Descriptive analyses (mean and standard deviation) were used to compare the Habitual condition to the Assist-Knee conditions.|||
72398968|NCT01566461|144304310|SUPERIORITY_OR_OTHER|||||||0.096|TWO_SIDED||||||Chi-squared|||||||0.096
72398969|NCT01566461|144304311|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Chi-squared|||||||<0.001
72475645|NCT04348435|144476699|SUPERIORITY||Mean Difference (Net)|3.689|STANDARD_ERROR_OF_MEAN|4.969||0.4642|TWO_SIDED|95.0|||||ANCOVA|||Average Emotional Well Being - Treatment Contrast||||0.4642
72475646|NCT04348435|144476699|SUPERIORITY||Mean Difference (Net)|2.268|STANDARD_ERROR_OF_MEAN|3.936||0.5692|TWO_SIDED|95.0|||||ANCOVA|||Average Emotional Well Being - Treatment Contrast||||0.5692
72475647|NCT04348435|144476699|SUPERIORITY||Median Difference (Net)|2.667|STANDARD_ERROR_OF_MEAN|3.592||0.4642|TWO_SIDED|95.0|||||ANCOVA|||Avg. Role Limitations Due to Emotional Problems - Treatment Contrast||||0.4642
72623155|NCT06045273|144776886|SUPERIORITY||Slope|0.224|STANDARD_ERROR_OF_MEAN|0.064||0.0006|TWO_SIDED||||||Satterthwaite approximations|Also used a mixed models analysis||||||0.0006
72623156|NCT06045273|144776887|SUPERIORITY||Slope|0.084|STANDARD_ERROR_OF_MEAN|0.043||0.0504|TWO_SIDED||||||Satterthwaite approximations|Also used a mixed models analysis||||||0.0504
72623157|NCT06045273|144776888|SUPERIORITY||Slope|0.131|STANDARD_ERROR_OF_MEAN|0.04||0.00134|TWO_SIDED||||||Satterthwaite approximations|Also used a mixed models analysis||||||0.00134
72623158|NCT02743221|144776901|OTHER|This was a non-comparative study.|Hazard Ratio (HR)|0.71||||0.09|TWO_SIDED|95.0|0.48|1.06|||Cox proportional hazard model|Cox proportional hazard model with adjustment for the stratification factors (RAS status, performance status ECOG)||||1.06|0.48|0.09
72623159|NCT02743221|144776902|OTHER|||||||0.73|||||||Fisher Exact|||||||0.73
72623160|NCT02743221|144776903|OTHER||Hazard Ratio (HR)|1.16|||||TWO_SIDED|95.0|0.49|2.74||||||||2.74|0.49|
72623161|NCT02743221|144776904|OTHER|||||||0.22|||||||Fisher Exact|||||||0.22
72623162|NCT02743221|144776905|OTHER||Hazard Ratio (HR)|0.56||||0.04|TWO_SIDED|95.0|0.32|0.98|||Cox proportional hazard model|||||0.98|0.32|0.04
72623163|NCT00437073|144776956|SUPERIORITY_OR_OTHER||percentage of participants|38.0|||||TWO_SIDED|95.0|13.9|68.4|||||The estimated value indicates the percentage of participants with CNS OR in the Lapatinib plus Capecitabine treatment arm.|||68.4|13.9|
72623164|NCT01441492|144776980|OTHER|||||||0.804|||||||Chi-squared|||the study is powered to be able to detect a 15% difference in the ≥ Grade II complication rate between the drain and no drain groups. A total of 342 evaluable patients will be needed for the two study groups (n=171 per group) in order to achieve 80% power to detect a 15% increase or decrease in the complication rate with a significance level of 0.05.||||0.804
72623165|NCT03514134|144776998|SUPERIORITY||||||<|0.001|||||||ANCOVA|Repeated measures ANCOVA||||||<0.001
72623166|NCT03514134|144776999|SUPERIORITY|||||||0.358|||||||ANCOVA|Repeated measures ANCOVA||||||0.358
72623167|NCT03514134|144777000|SUPERIORITY|||||||0.029|||||||ANCOVA|Repeated measures ANCOVA||||||0.029
72623168|NCT03514134|144777001|SUPERIORITY||||||<|0.01|||||||Chi-squared|||||||<0.01
72623169|NCT03514134|144777001|SUPERIORITY||||||<|0.05|||||||Regression, Logistic|||||||<0.05
72623170|NCT03514134|144777002|SUPERIORITY|||||||0.7||||||Group by time interaction|ANOVA|Repeated measures ANOVA||||||0.70
72623171|NCT02471144|144777003|SUPERIORITY||Odds Ratio (OR)|25.78|||<|0.0001|TWO_SIDED|95.0|7.08|114.66|||Regression, Logistic|||vs Placebo||114.66|7.08|<.0001
72623172|NCT02471144|144777003|SUPERIORITY||Odds Ratio (OR)|22.65|||<|0.0001|TWO_SIDED|95.0|6.31|98.93|||Regression, Logistic|||vs Placebo||98.93|6.31|<.0001
72623173|NCT02471144|144777004|SUPERIORITY||Odds Ratio (OR)|51.77|||<|0.0001|TWO_SIDED|95.0|10.02|538.64|||Regression, Logistic|||vs Placebo||538.64|10.02|<.0001
72623174|NCT02471144|144777004|SUPERIORITY||Odds Ratio (OR)|32.52|||<|0.0001||95.0|6.48|329.52|||Regression, Logistic|||vs Placebo||329.52|6.48|<.0001
72623175|NCT02471144|144777005|SUPERIORITY||Odds Ratio (OR)|72.5|||<|0.0001|TWO_SIDED|95.0|55.9|84.9|||Regression, Logistic|||vs Placebo||84.9|55.9|<.0001
72623176|NCT02471144|144777005|SUPERIORITY||Odds Ratio (OR)|67.5|||<|0.0001|TWO_SIDED|95.0|50.8|80.9|||Regression, Logistic|||vs Placebo||80.9|50.8|<.0001
72623177|NCT00107575|144777023|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||Chi-squared|||||||>.05
72623178|NCT00107575|144777024|SUPERIORITY_OR_OTHER||expected count ratio|0.81||||0.027|TWO_SIDED|95.0|0.67|0.98||a priori p-value was p \< .05|generalized estimating equations|Negative binomial model controlling for sex, motivation to change drinking, and baseline drinking||||0.98|0.67|.027
72507614|NCT01663740|144547012|SUPERIORITY_OR_OTHER||Mean Difference|-21.828|STANDARD_ERROR_OF_MEAN|9.1214||0.0222|TWO_SIDED|95.0|-40.346|-3.311|||Mixed Models Analysis|Model adjusted for Cohort,visit,Cohort by visit interaction,baseline sperm motility,age,duration of pre-transplant dialysis as explanatory variables.|Change in total motility of sperm from Baseline to EOT|||-3.311|-40.346|0.0222
72507615|NCT01663740|144547012|SUPERIORITY_OR_OTHER||Mean Difference|-9.802|STANDARD_ERROR_OF_MEAN|8.3702||0.2495|TWO_SIDED|95.0|-26.795|7.19|||Mixed Models Analysis|Model adjusted for Cohort,visit,Cohort by visit interaction,baseline sperm motility,age,duration of pre-transplant dialysis as explanatory variables.|Change in total motility of sperm from Baseline to end of FU|||7.190|-26.795|0.2495
72507616|NCT01663740|144547013|SUPERIORITY_OR_OTHER||Mean Difference|-11.683|STANDARD_ERROR_OF_MEAN|12.2576||0.3505|TWO_SIDED|95.0|-37.039|13.674|||Mixed Models Analysis|Model adjusted for Cohort,visit,Cohort by visit interaction,baseline sperm motility,age,duration of pre-transplant dialysis as explanatory variables.|Change in total motility of sperm from EOT to end of FU|||13.674|-37.039|0.3505
72507617|NCT01663740|144547014|SUPERIORITY_OR_OTHER||Mean Difference|-5.741|STANDARD_ERROR_OF_MEAN|6.7578||0.4021|TWO_SIDED|95.0|-19.524|8.042|||Mixed Models Analysis|Model adjusted for Cohort,visit,Cohort by visit interaction,baseline sperm morphology,age,pre-transplant dialysis duration as explanatory variables.|Change in sperm morphology from Baseline to EOT|||8.042|-19.524|0.4021
72507618|NCT01663740|144547014|SUPERIORITY_OR_OTHER||Mean Difference|-1.854|STANDARD_ERROR_OF_MEAN|5.1817||0.7229|TWO_SIDED|95.0|-12.423|8.714|||Mixed Models Analysis|Model adjusted for Cohort,visit,Cohort by visit interaction,baseline sperm morphology,age,pre-transplant dialysis duration as explanatory variables.|Change in sperm morphology from Baseline to end of FU|||8.714|-12.423|0.7229
72507619|NCT01663740|144547015|SUPERIORITY_OR_OTHER||Mean Difference|-2.95|STANDARD_ERROR_OF_MEAN|7.7598||0.708|TWO_SIDED|95.0|-19.192|13.291|||Mixed Models Analysis|Model adjusted for Cohort,visit,Cohort by visit interaction,baseline sperm morphology,age,pre-transplant dialysis duration as explanatory variables.|Change in sperm morphology from EOT to end of FU|||13.291|-19.192|0.7080
72507620|NCT01663740|144547016|SUPERIORITY_OR_OTHER||Mean Difference|-1.861|STANDARD_ERROR_OF_MEAN|1.6512||0.2673|TWO_SIDED|95.0|-5.213|1.491|||Mixed Models Analysis|Model adjusted for Cohort,visit,Cohort by visit interaction,baseline testosterone,age,duration of pre-transplant dialysis as explanatory variables.|Change in total testosterone level from Baseline to EOT|||1.491|-5.213|0.2673
72507621|NCT01663740|144547016|SUPERIORITY_OR_OTHER||Mean Difference|-1.114|STANDARD_ERROR_OF_MEAN|1.6147||0.4949|TWO_SIDED|95.0|-4.392|2.164|||Mixed Models Analysis|Model adjusted for Cohort,visit,Cohort by visit interaction,baseline testosterone,age,duration of pre-transplant dialysis as explanatory variables.|Change in total testosterone level from Baseline to end of FU|||2.164|-4.392|0.4949
72507622|NCT01663740|144547017|SUPERIORITY_OR_OTHER||Mean Difference|0.047|STANDARD_ERROR_OF_MEAN|1.51||0.9753|TWO_SIDED|95.0|-3.063|3.157|||Mixed Models Analysis|Model adjusted for Cohort,visit,Cohort by visit interaction,baseline testosterone,age,duration of pre-transplant dialysis as explanatory variables.|Change in total testosterone level from EOT to end of FU|||3.157|-3.063|0.9753
72507623|NCT01663740|144547018|SUPERIORITY_OR_OTHER||Mean Difference|0.076|STANDARD_ERROR_OF_MEAN|0.6347||0.9053|TWO_SIDED|95.0|-1.214|1.366|||Mixed Models Analysis|Model adjusted for Cohort,visit,Cohort by visit interaction,baseline LH concentration,age,pre-transplant dialysis duration as explanatory variables.|Change in LH level from Baseline to EOT|||1.366|-1.214|0.9053
72507624|NCT01663740|144547018|SUPERIORITY_OR_OTHER||Mean Difference|-1.215|STANDARD_ERROR_OF_MEAN|0.4477||0.0104|TWO_SIDED|95.0|-2.125|-0.305|||Mixed Models Analysis|Model adjusted for Cohort,visit,Cohort by visit interaction,baseline LH concentration,age,pre-transplant dialysis duration as explanatory variables.|Change in LH level from Baseline to end of FU|||-0.305|-2.125|0.0104
72507625|NCT01663740|144547019|SUPERIORITY_OR_OTHER||Mean Difference|-1.065|STANDARD_ERROR_OF_MEAN|0.4057||0.0143|TWO_SIDED|95.0|-1.899|-0.231|||Mixed Models Analysis|Model adjusted for Cohort,visit,Cohort by visit interaction,baseline LH concentration,age,\& pre-transplant dialysis duration as explanatory variables.|Change in LH level from EOT to end of FU|||-0.231|-1.899|0.0143
72507626|NCT01663740|144547020|SUPERIORITY_OR_OTHER||Mean Difference|2.541|STANDARD_ERROR_OF_MEAN|1.7274||0.1505|TWO_SIDED|95.0|-0.969|6.052|||Mixed Models Analysis|Model adjusted for Cohort,visit,Cohort by visit interaction,baseline FSH concentration,age,pre-transplant dialysis duration as explanatory variables.|Change in FSH level from Baseline to EOT|||6.052|-0.969|0.1505
72507627|NCT01663740|144547020|SUPERIORITY_OR_OTHER||Mean Difference|-0.983|STANDARD_ERROR_OF_MEAN|0.6739||0.1539|TWO_SIDED|95.0|-2.352|0.387|||Mixed Models Analysis|Model adjusted for Cohort,visit,Cohort by visit interaction,baseline FSH concentration,age,pre-transplant dialysis duration as explanatory variables.|Change in FSH level from Baseline to end of FU|||0.387|-2.352|0.1539
72507628|NCT01663740|144547021|SUPERIORITY_OR_OTHER||Mean Difference|-1.474|STANDARD_ERROR_OF_MEAN|0.8084||0.0798|TWO_SIDED|95.0|-3.136|0.188|||Mixed Models Analysis|Model adjusted for Cohort,visit,Cohort by visit interaction,baseline FSH concentration,age,pre-transplant dialysis duration as explanatory variables.|Change in FSH level from EOT to end of FU|||0.188|-3.136|0.0798
72507629|NCT01663740|144547022|SUPERIORITY_OR_OTHER||Mean Difference|-0.104|STANDARD_ERROR_OF_MEAN|23.466||0.9965|TWO_SIDED|95.0|-47.792|47.585|||Mixed Models Analysis|Model adjusted for Cohort,visit,Cohort by visit interaction,baseline prolactin level,age,pre-transplant dialysis duration as explanatory variables.|Change in prolactin level from Baseline to EOT|||47.585|-47.792|0.9965
72507630|NCT01663740|144547022|SUPERIORITY_OR_OTHER||Mean Difference|15.272|STANDARD_ERROR_OF_MEAN|20.6031||0.4636|TWO_SIDED|95.0|-26.599|57.142|||Mixed Models Analysis|Model adjusted for Cohort,visit,Cohort by visit interaction,baseline prolactin level,age,pre-transplant dialysis duration as explanatory variables.|Change in prolactin level from Baseline to end of FU|||57.142|-26.599|0.4636
72507631|NCT01663740|144547023|SUPERIORITY_OR_OTHER||Mean Difference|8.74|STANDARD_ERROR_OF_MEAN|17.0805||0.6134|TWO_SIDED|95.0|-26.438|43.917|||Mixed Models Analysis|Model adjusted for Cohort,visit,Cohort by visit interaction,baseline prolactin level,age,pre-transplant dialysis duration as explanatory variables.|Change in prolactin level from EOT to end of FU|||43.917|-26.438|0.6134
72507632|NCT01663740|144547024|SUPERIORITY_OR_OTHER||Mean Difference|8.142|STANDARD_ERROR_OF_MEAN|11.9301||0.5002|TWO_SIDED|95.0|-16.223|32.506|||Mixed Models Analysis|Model adjusted for Cohort,visit,Cohort by visit interaction,baseline inhibin B level,age,pre-transplant dialysis duration as explanatory variables.|Change in inhibin B level from Baseline to EOT|||32.506|-16.223|0.5002
72623179|NCT00107575|144777025|SUPERIORITY_OR_OTHER|||||||0.18||95.0|||||Chi-squared|||||||.18
72475648|NCT04348435|144476699|SUPERIORITY||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|4.444||1|TWO_SIDED|95.0|||||ANCOVA|||Avg. Role Limitations Due to Emotional Problems - Treatment Contrast||||1.0000
72475649|NCT04348435|144476699|SUPERIORITY||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|3.526||1|TWO_SIDED|95.0|||||ANCOVA|||Avg. Role Limitations Due to Emotional Problems - Treatment Contrast||||1.0000
72475650|NCT04348435|144476700|SUPERIORITY||Mean Difference (Net)|-0.144|STANDARD_ERROR_OF_MEAN|0.825||0.8628|TWO_SIDED|95.0|||||ANCOVA|||||||0.8628
72475651|NCT04348435|144476700|SUPERIORITY||Mean Difference (Net)|-0.605|STANDARD_ERROR_OF_MEAN|0.94||0.5257|TWO_SIDED|95.0|||||ANCOVA|||||||0.5257
72475652|NCT04348435|144476700|SUPERIORITY||Mean Difference (Net)|-0.403|STANDARD_ERROR_OF_MEAN|0.659||0.5467|TWO_SIDED|95.0|||||ANCOVA|||||||0.5467
72507633|NCT01663740|144547024|SUPERIORITY_OR_OTHER||Mean Difference|40.682|STANDARD_ERROR_OF_MEAN|17.6084||0.0279|TWO_SIDED|95.0|4.72|76.643|||Mixed Models Analysis|Model adjusted for Cohort,visit,Cohort by visit interaction,baseline inhibin B level,age,pre-transplant dialysis duration as explanatory variables.|Change in inhibin B level from Baseline to end of FU|||76.643|4.720|0.0279
72507634|NCT01663740|144547025|SUPERIORITY_OR_OTHER||Mean Difference|25.881|STANDARD_ERROR_OF_MEAN|22.1348||0.2548|TWO_SIDED|95.0|-20.024|71.786|||Mixed Models Analysis|Model adjusted for Cohort,visit,Cohort by visit interaction,baseline inhibin B level,age,pre-transplant dialysis duration as explanatory variables|Change in inhibin B level from EOT to end of FU|||71.786|-20.024|0.2548
72507635|NCT01663740|144547026|SUPERIORITY_OR_OTHER||Difference in Percentage|14.3|||||TWO_SIDED|95.0|-19.3|45.3|||||Change in abnormal to abnormal sperm density from Baseline to EOT|||45.3|-19.3|
72507636|NCT01663740|144547026|SUPERIORITY_OR_OTHER||Difference in Percentage|5.0|||||TWO_SIDED|95.0|-34.3|43.3|||||Change in abnormal to abnormal sperm density from Baseline to end of FU|||43.3|-34.3|
72507637|NCT01663740|144547026|SUPERIORITY_OR_OTHER||Difference in Percentage|17.9|||||TWO_SIDED|95.0|-15.3|48.8|||||Change in normal to abnormal sperm density from Baseline to EOT|||48.8|-15.3|
72507638|NCT01663740|144547027|SUPERIORITY_OR_OTHER||Difference in Percentage|4.1|||||TWO_SIDED|95.0|-34.5|42.5|||||Change in abnormal to abnormal sperm density from EOT to end of FU|||42.5|-34.5|
72507639|NCT01663740|144547028|SUPERIORITY_OR_OTHER||Difference in Percentage|1.3|||||TWO_SIDED|95.0|-31.3|33.7|||||Improvement from Baseline to EOT|||33.7|-31.3|
72507640|NCT01663740|144547028|SUPERIORITY_OR_OTHER||Difference in Percentage|6.7|||||TWO_SIDED|95.0|-31.1|44.4|||||Improvement from Baseline to end of FU|||44.4|-31.1|
72398970|NCT01566461|144304312|SUPERIORITY_OR_OTHER|||||||0.121|TWO_SIDED||||||Chi-squared|||||||0.121
72475653|NCT00923260|144476714|SUPERIORITY_OR_OTHER|||||||0.79||95.0|||||t-test, 2 sided|||||||0.79
72475654|NCT00923260|144476715|SUPERIORITY_OR_OTHER|||||||0.49||95.0|||||t-test, 2 sided|||||||0.49
72475655|NCT00923260|144476716|SUPERIORITY_OR_OTHER|||||||0.96||95.0|||||t-test, 2 sided|||||||0.96
72475656|NCT00923260|144476717|SUPERIORITY_OR_OTHER|||||||0.86||95.0|||||t-test, 2 sided|||||||.86
72475657|NCT00923260|144476718|SUPERIORITY_OR_OTHER|||||||0.6||95.0|||||t-test, 2 sided|||||||0.60
72507641|NCT01663740|144547029|SUPERIORITY_OR_OTHER||Difference in Percentage|-11.8|||||TWO_SIDED|95.0|-50.0|29.3|||||Improvement from EOT to end of FU|||29.3|-50.0|
72507642|NCT01663740|144547030|SUPERIORITY_OR_OTHER||Difference in Percentage|-31.0|||||TWO_SIDED|95.0|-59.7|2.7|||||Improvement from Baseline to EOT|||2.7|-59.7|
72507643|NCT01663740|144547030|SUPERIORITY_OR_OTHER||Difference in Percentage|10.0|||||TWO_SIDED|95.0|-29.7|47.7|||||Improvement from Baseline to end of FU|||47.7|-29.7|
72398971|NCT01566461|144304313|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED||||||Chi-squared|||||||0.001
72475658|NCT00923260|144476719|SUPERIORITY_OR_OTHER|||||||0.76||95.0|||||t-test, 2 sided|||||||0.76
72475659|NCT00923260|144476720|SUPERIORITY_OR_OTHER|||||||0.45||95.0|||||t-test, 2 sided|||||||0.45
72475660|NCT00923260|144476721|SUPERIORITY_OR_OTHER|||||||0.81||95.0|||||t-test, 2 sided|||||||0.81
72475661|NCT00923260|144476722|SUPERIORITY_OR_OTHER|||||||0.92||95.0|||||t-test, 2 sided|||||||0.92
72475662|NCT00923260|144476723|SUPERIORITY_OR_OTHER|||||||0.01||95.0|||||t-test, 2 sided|||||||0.01
72475663|NCT00923260|144476724|SUPERIORITY_OR_OTHER|||||||0.15||95.0|||||t-test, 2 sided|||||||0.15
72475664|NCT00923260|144476725|SUPERIORITY_OR_OTHER|||||||0.2||95.0|||||t-test, 2 sided|||||||0.20
72475665|NCT00923260|144476726|SUPERIORITY_OR_OTHER|||||||0.64||95.0|||||t-test, 2 sided|||||||0.64
72475666|NCT00923260|144476727|SUPERIORITY_OR_OTHER|||||||0.92||95.0|||||t-test, 2 sided|||||||0.92
72475667|NCT00923260|144476728|SUPERIORITY_OR_OTHER||||||<|0.01||95.0|||||t-test, 2 sided|||||||<0.01
72475668|NCT00923260|144476729|SUPERIORITY_OR_OTHER|||||||0.21||95.0|||||t-test, 2 sided|||||||0.21
72475669|NCT00923260|144476730|SUPERIORITY_OR_OTHER|||||||0.65||95.0|||||t-test, 2 sided|||||||0.65
72475670|NCT00923260|144476731|SUPERIORITY_OR_OTHER|||||||0.33||95.0|||||t-test, 2 sided|||||||0.33
72475671|NCT00923260|144476732|SUPERIORITY_OR_OTHER|||||||0.39||95.0|||||t-test, 2 sided|||||||0.39
72475672|NCT00923260|144476733|SUPERIORITY_OR_OTHER|||||||0.47||95.0|||||t-test, 2 sided|||||||0.47
72475673|NCT00923260|144476734|SUPERIORITY_OR_OTHER|||||||0.75||95.0|||||t-test, 2 sided|||||||0.75
72475674|NCT00923260|144476735|SUPERIORITY_OR_OTHER|||||||0.94||95.0|||||t-test, 2 sided|||||||0.94
72475675|NCT00923260|144476736|SUPERIORITY_OR_OTHER|||||||0.74||95.0|||||t-test, 2 sided|||||||0.74
72475676|NCT00923260|144476737|SUPERIORITY_OR_OTHER|||||||0.72||95.0|||||t-test, 2 sided|||||||0.72
72475677|NCT00923260|144476738|SUPERIORITY_OR_OTHER|||||||0.67||95.0|||||t-test, 2 sided|||||||0.67
72475678|NCT00923260|144476739|SUPERIORITY_OR_OTHER|||||||0.64||95.0|||||t-test, 2 sided|||||||0.64
72475679|NCT00923260|144476740|SUPERIORITY_OR_OTHER|||||||0.038||95.0|||||t-test, 2 sided|||||||0.038
72475680|NCT00923260|144476741|SUPERIORITY_OR_OTHER|||||||0.14||95.0|||||t-test, 2 sided|||||||0.14
72475681|NCT00923260|144476742|SUPERIORITY_OR_OTHER|||||||0.21||95.0|||||t-test, 2 sided|||||||0.21
72507644|NCT01663740|144547031|SUPERIORITY_OR_OTHER||Difference in Percentage|-9.9|||||TWO_SIDED|95.0|-47.2|27.9|||||Improvement from EOT to end of FU|||27.9|-47.2|
72507645|NCT02574312|144547066|NON_INFERIORITY|Non-Inferiority Analysis of absolute value of mechanical axis alignment with NI margin of 1.5 degrees, using a 1-sided T-test with alpha of 0.05. Anticipated power was 95%.||||||0.028|||||||t-test, 1 sided|||||||0.028
72623180|NCT00107575|144777026|SUPERIORITY_OR_OTHER|||||||0.95||95.0|||||Chi-squared|||||||.95
72623181|NCT00107575|144777027|SUPERIORITY_OR_OTHER|||||||0.76||95.0|||||Chi-squared|||||||.76
72398972|NCT01566461|144304314|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Chi-squared|||||||<0.001
72398973|NCT01566461|144304315|SUPERIORITY_OR_OTHER|||||||0.095|TWO_SIDED||||||t-test, 1 sided|||||||0.095
72398974|NCT01566461|144304316|SUPERIORITY_OR_OTHER|||||||0.878|TWO_SIDED||||||t-test, 1 sided|||||||0.878
72398975|NCT01566461|144304317|SUPERIORITY_OR_OTHER|||||||0.59|TWO_SIDED||||||t-test, 1 sided|||||||0.590
72398976|NCT01566461|144304318|SUPERIORITY_OR_OTHER|||||||0.302|TWO_SIDED||||||Chi-squared|||||||0.302
72398977|NCT01566461|144304319|SUPERIORITY_OR_OTHER|||||||0.111|TWO_SIDED||||||Chi-squared|||||||0.111
72398978|NCT01566461|144304320|SUPERIORITY_OR_OTHER|||||||0.103|TWO_SIDED||||||Chi-squared|||||||0.103
72398979|NCT01566461|144304321|SUPERIORITY_OR_OTHER|||||||0.049|TWO_SIDED||||||t-test, 1 sided|||||||0.049
72398980|NCT01474876|144304332|SUPERIORITY_OR_OTHER|||||||0.0164|TWO_SIDED||||||Regression, Logistic|||Treatment response and participant age||||0.0164
72398981|NCT01474876|144304332|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED||||||Regression, Logistic|||Treatment response and presence of enthesitis at Visit 0||||0.0200
72398982|NCT01474876|144304332|SUPERIORITY_OR_OTHER|||||||0.0867|TWO_SIDED||||||Regression, Logistic|||Treatment response and BASDAI score at Visit 0||||0.0867
72398983|NCT01474876|144304332|SUPERIORITY_OR_OTHER|||||||0.0001|TWO_SIDED||||||Regression, Logistic|||Remission and participant age||||0.0001
72398984|NCT01474876|144304332|SUPERIORITY_OR_OTHER|||||||0.0734|TWO_SIDED||||||Regression, Logistic|||Remission and positive tuberculosis screening at Visit 0||||0.0734
72398985|NCT01474876|144304332|SUPERIORITY_OR_OTHER|||||||0.0438|TWO_SIDED||||||Regression, Logistic|||Remission and male gender||||0.0438
72398986|NCT01474876|144304332|SUPERIORITY_OR_OTHER|||||||0.503|TWO_SIDED||||||Regression, Logistic|||Remission and BASDAI score at Visit 0||||0.5030
72398987|NCT01474876|144304341|SUPERIORITY_OR_OTHER|||||||0.0576|TWO_SIDED||||||Regression, Logistic|||Treatment response and presence of enthesitis at Visit 0||||0.0576
72398988|NCT01474876|144304341|SUPERIORITY_OR_OTHER|||||||0.1739|TWO_SIDED||||||Regression, Logistic|||Treatment response and BASDAI score at Visit 0||||0.1739
72398989|NCT01474876|144304341|SUPERIORITY_OR_OTHER|||||||0.0733|TWO_SIDED||||||Regression, Logistic|||Remission and Psoriasis at Visit 0||||0.0733
72398990|NCT01474876|144304341|SUPERIORITY_OR_OTHER|||||||0.5|TWO_SIDED||||||Regression, Logistic|||Remission and BASDAI at Visit 0||||0.5000
72398991|NCT02226003|144304399|SUPERIORITY_OR_OTHER||Difference in the Least Squares Means|-1.16|||<|0.001|TWO_SIDED|95.0|-1.49|-0.84|||Constrained Longitudinal Data Analysis|||||-0.84|-1.49|< 0.001
72398992|NCT02226003|144304399|SUPERIORITY_OR_OTHER||Difference in the Least Squares Means|-1.24|||<|0.001|TWO_SIDED|95.0|-1.57|-0.91|||Constrained Longitudinal Data Analysis|||||-0.91|-1.57|< 0.001
72398993|NCT02226003|144304400|SUPERIORITY_OR_OTHER||Difference in Percentage vs Placebo|2.6|||||TWO_SIDED|95.0|-11.2|16.4||||||||16.4|-11.2|
72398994|NCT02226003|144304400|SUPERIORITY_OR_OTHER||Difference in Percentage vs Placebo|2.5|||||TWO_SIDED|95.0|-11.4|16.4||||||||16.4|-11.4|
72398995|NCT02226003|144304402|SUPERIORITY_OR_OTHER||Difference in the Least Squares Means|-38.94|||<|0.001|TWO_SIDED|95.0|-49.93|-27.96|||Constrained Longitudinal Data Analysis|||||-27.96|-49.93|< 0.001
72398996|NCT02226003|144304402|SUPERIORITY_OR_OTHER||Difference in the Least Squares Means|-46.05|||<|0.001|TWO_SIDED|95.0|-57.09|-35.02|||Constrained Longitudinal Data Analysis|||||-35.02|-57.09|< 0.001
72398997|NCT02226003|144304403|SUPERIORITY_OR_OTHER||Difference in the Least Squares Means|-62.42|||<|0.001|TWO_SIDED|95.0|-80.47|-44.37|||Constrained Longitudinal Data Analysis|||||-44.37|-80.47|< 0.001
72475682|NCT00923260|144476743|SUPERIORITY_OR_OTHER|||||||0.42||95.0|||||t-test, 2 sided|||||||0.42
72475683|NCT00923260|144476744|SUPERIORITY_OR_OTHER|||||||0.18||95.0|||||t-test, 2 sided|||||||0.18
72475684|NCT00923260|144476745|SUPERIORITY_OR_OTHER|||||||0.1||95.0|||||t-test, 2 sided|||||||0.10
72475685|NCT00923260|144476746|SUPERIORITY_OR_OTHER|||||||0.16||95.0|||||t-test, 2 sided|||||||0.16
72475686|NCT00923260|144476747|SUPERIORITY_OR_OTHER|||||||0.18||95.0|||||t-test, 2 sided|||||||0.18
72475687|NCT00923260|144476748|SUPERIORITY_OR_OTHER|||||||0.4||95.0|||||t-test, 2 sided|||||||0.40
72475688|NCT00923260|144476749|SUPERIORITY_OR_OTHER|||||||0.44||95.0|||||t-test, 2 sided|||||||0.44
72475689|NCT00923260|144476750|SUPERIORITY_OR_OTHER|||||||0.035||95.0|||||t-test, 2 sided|||||||0.035
72475690|NCT00923260|144476751|SUPERIORITY_OR_OTHER|||||||0.07||95.0|||||t-test, 2 sided|||||||0.07
72475691|NCT00923260|144476752|SUPERIORITY_OR_OTHER|||||||0.99||95.0|||||t-test, 2 sided|||||||0.99
72475692|NCT00923260|144476753|SUPERIORITY_OR_OTHER|||||||0.96||95.0|||||t-test, 2 sided|||||||0.96
72475693|NCT00923260|144476754|SUPERIORITY_OR_OTHER|||||||0.44||95.0|||||t-test, 2 sided|||||||0.44
72475694|NCT00923260|144476755|SUPERIORITY_OR_OTHER|||||||0.97||95.0|||||t-test, 2 sided|||||||0.97
72475695|NCT00923260|144476756|SUPERIORITY_OR_OTHER|||||||0.85||95.0|||||t-test, 2 sided|||||||0.85
72475696|NCT00923260|144476757|SUPERIORITY_OR_OTHER|||||||0.61||95.0|||||t-test, 2 sided|||||||0.61
72475697|NCT00923260|144476758|SUPERIORITY_OR_OTHER|||||||0.55||95.0|||||t-test, 2 sided|||||||0.55
72475698|NCT00923260|144476759|SUPERIORITY_OR_OTHER|||||||0.65||95.0|||||t-test, 2 sided|||||||0.65
72475699|NCT00923260|144476760|SUPERIORITY_OR_OTHER|||||||0.74||95.0|||||t-test, 2 sided|||||||0.74
72475700|NCT00923260|144476761|SUPERIORITY_OR_OTHER|||||||0.57||95.0|||||t-test, 2 sided|||||||0.57
72475701|NCT00923260|144476762|SUPERIORITY_OR_OTHER|||||||0.87||95.0|||||t-test, 2 sided|||||||0.87
72475702|NCT00923260|144476763|SUPERIORITY_OR_OTHER|||||||0.28||95.0|||||t-test, 2 sided|||||||0.28
72475703|NCT00923260|144476764|SUPERIORITY_OR_OTHER|||||||0.64||95.0|||||t-test, 2 sided|||||||0.64
72475704|NCT00923260|144476765|SUPERIORITY_OR_OTHER|||||||0.42||95.0|||||t-test, 2 sided|||||||0.42
72475705|NCT00923260|144476766|SUPERIORITY_OR_OTHER|||||||0.72||95.0|||||t-test, 2 sided|||||||0.72
72475706|NCT00923260|144476767|SUPERIORITY_OR_OTHER|||||||0.68||95.0|||||t-test, 2 sided|||||||0.68
72475707|NCT00923260|144476768|SUPERIORITY_OR_OTHER|||||||0.08||95.0|||||t-test, 2 sided|||||||0.08
72475708|NCT00923260|144476769|SUPERIORITY_OR_OTHER|||||||0.71||95.0|||||t-test, 2 sided|||||||0.71
72475709|NCT00923260|144476770|SUPERIORITY_OR_OTHER|||||||0.32||95.0|||||t-test, 2 sided|||||||0.32
72475710|NCT00923260|144476771|SUPERIORITY_OR_OTHER|||||||0.64||95.0|||||t-test, 2 sided|||||||0.64
72475711|NCT00923260|144476772|SUPERIORITY_OR_OTHER|||||||0.52||95.0|||||t-test, 2 sided|||||||0.52
72398998|NCT02226003|144304403|SUPERIORITY_OR_OTHER||Difference in the Least Squares Means|-69.65|||<|0.001|TWO_SIDED|95.0|-87.83|-51.46|||Constrained Longitudinal Data Analysis|||||-51.46|-87.83|< 0.001
72398999|NCT02226003|144304404|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.88|||<|0.001|TWO_SIDED|95.0|2.81|16.83|||Logistic regression model|||||16.83|2.81|< 0.001
72399000|NCT02226003|144304404|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|7.39|||<|0.001|TWO_SIDED|95.0|2.98|18.31|||Logistic regression model|||||18.31|2.98|< 0.001
72399001|NCT02226003|144304405|SUPERIORITY_OR_OTHER||Difference in the Least Squares Means|-2.0|||<|0.001|TWO_SIDED|95.0|-2.99|-1.01|||Constrained Longitudinal Data Analysis|||||-1.01|-2.99|< 0.001
72399002|NCT02226003|144304405|SUPERIORITY_OR_OTHER||Difference in the Least Squares Means|-2.1|||<|0.001|TWO_SIDED|95.0|-3.1|-1.11|||Constrained Longitudinal Data Analysis|||||-1.11|-3.10|< 0.001
72399003|NCT02226003|144304406|SUPERIORITY_OR_OTHER||Difference in the Least Squares Means|-4.44||||0.011|TWO_SIDED|95.0|-7.87|-1.01|||Constrained Longitudinal Data Analysis|||||-1.01|-7.87|0.011
72399004|NCT02226003|144304406|SUPERIORITY_OR_OTHER||Difference in the Least Squares Means|-6.39|||<|0.001|TWO_SIDED|95.0|-9.83|-2.95|||Constrained Longitudinal Data Analysis|||||-2.95|-9.83|< 0.001
72399005|NCT02226003|144304407|SUPERIORITY_OR_OTHER||Difference in the Least Squares Means|-1.65||||0.184|TWO_SIDED|95.0|-4.09|0.79|||Constrained Longitudinal Data Analysis|||||0.79|-4.09|0.184
72399006|NCT02226003|144304407|SUPERIORITY_OR_OTHER||Difference in the Least Squares Means|-2.18||||0.08|TWO_SIDED|95.0|-4.62|0.26|||Constrained Longitudinal Data Analysis|||||0.26|-4.62|0.080
72399007|NCT02467465|144304409|SUPERIORITY|||||||0.175|||||||Wilcoxon (Mann-Whitney)|||||||0.175
72399008|NCT02467465|144304410|SUPERIORITY|||||||0.25|||||||Wilcoxon (Mann-Whitney)|||||||0.250
72399009|NCT02467465|144304411|SUPERIORITY|||||||0.466|||||||Wilcoxon (Mann-Whitney)|||||||0.466
72399010|NCT02467465|144304413|SUPERIORITY|||||||0.737|||||||Wilcoxon (Mann-Whitney)|||||||0.737
72399011|NCT02467465|144304414|SUPERIORITY|||||||0.275|||||||Wilcoxon (Mann-Whitney)|||||||0.275
72507646|NCT02078713|144547125|SUPERIORITY||Odds Ratio (OR)|0.89||||0.46|TWO_SIDED|95.0|0.65|1.22||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison at 7 months post-enrollment||1.22|0.65|0.46
72399012|NCT02467465|144304415|SUPERIORITY|||||||0.066|||||||Wilcoxon (Mann-Whitney)|||||||0.066
72399013|NCT02467465|144304417|SUPERIORITY|||||||0.849|||||||Wilcoxon (Mann-Whitney)|||||||0.849
72399014|NCT02467465|144304418|SUPERIORITY|||||||0.425|||||||Wilcoxon (Mann-Whitney)|||||||0.425
72399015|NCT02467465|144304419|SUPERIORITY|||||||0.487|||||||Wilcoxon (Mann-Whitney)|||||||0.487
72399016|NCT02467465|144304421|SUPERIORITY|||||||0.651|||||||t-test, 1 sided|||||||0.651
72399017|NCT02467465|144304422|SUPERIORITY|||||||0.387|||||||t-test, 1 sided|||||||0.387
72475712|NCT00923260|144476773|SUPERIORITY_OR_OTHER|||||||0.59||95.0|||||t-test, 2 sided|||||||0.59
72475713|NCT00923260|144476774|SUPERIORITY_OR_OTHER|||||||0.57||95.0|||||t-test, 2 sided|||||||0.57
72475714|NCT00923260|144476775|SUPERIORITY_OR_OTHER|||||||0.43||95.0|||||t-test, 2 sided|||||||0.43
72475715|NCT00923260|144476776|SUPERIORITY_OR_OTHER|||||||0.72||95.0|||||t-test, 2 sided|||||||0.72
72475716|NCT00923260|144476777|SUPERIORITY_OR_OTHER|||||||0.56||95.0|||||t-test, 2 sided|||||||0.56
72475717|NCT00660543|144476778|SUPERIORITY_OR_OTHER|||||||0.003|||||||t-test, 1 sided|Differences between groups were assessed by using the Student paired t test and were graphed by using Bland-Altman plots.||||||.003
72399018|NCT02467465|144304423|SUPERIORITY|||||||0.755|||||||t-test, 1 sided|||||||0.755
72399019|NCT02467465|144304425|SUPERIORITY|||||||0.032|||||||t-test, 1 sided|||||||0.032
72399020|NCT02467465|144304426|SUPERIORITY|||||||0.058|||||||t-test, 1 sided|||||||0.058
72399021|NCT02467465|144304427|SUPERIORITY|||||||0.279|||||||t-test, 1 sided|||||||0.279
72399022|NCT04958785|144304447|SUPERIORITY||Hazard Ratio (HR)|0.456||||0.1617|TWO_SIDED|95.0|0.147|1.409|||Log Rank||Hazard Ratio (HR) along with its 2-sided 95% confidence interval (CI) were estimated using the Cox proportional hazards regression model.|||1.409|0.147|0.1617
72399023|NCT04958785|144304449|SUPERIORITY||Odds Ratio (OR)|2.037|||||TWO_SIDED|95.0|0.379|10.938|||||Odds ratios and corresponding 95% CIs were estimated using chi-square test.|||10.938|0.379|
72475718|NCT00660543|144476778|SUPERIORITY_OR_OTHER|||||||0.008|||||||t-test, 1 sided|Differences between groups were assessed by using the Student paired t test and were graphed by using Bland-Altman plots.||||||.008
72475719|NCT03829475|144476780|SUPERIORITY|||||||0.15|||||||Wilcoxon (Mann-Whitney)|||||||0.15
72475720|NCT00359216|144476827|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9219||95.0|||||ANCOVA|||The p-value is obtained by F-test in ANCOVA to assess the treatment group difference in changes from baseline, adjusted for baseline.||||0.9219
72475721|NCT00943852|144476883|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||1-sided, alpha = 0.05|ANOVA|Fixed effects model with terms for subject, treatment and period||||||<0.001
72475722|NCT00943852|144476884|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||1-sided, alpha = 0.05|ANOVA|Fixed effects model with terms for subject, treatment and period||||||<0.001
72475723|NCT04075994|144476902|SUPERIORITY|||||||0.22||||||A priori threshold for statistical significance p\<0.05.|t-test, 2 sided|||Proportion of days covered assessed as a continuous measure (range 0-1) at 12 months between study arms adjusted for trial stratification factors (type of anticoagulant treatment). We determined that a sample size of 120 in the intervention group and 120 in the control group enables us to detect a minimum difference in PDC as small as 12.6% with 90% power. Power calculations assume use of 2-sided tests with 0.05 significance level.||||0.22
72507647|NCT02078713|144547125|SUPERIORITY||Odds Ratio (OR)|0.79||||0.16|TWO_SIDED|95.0|0.57|1.1||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison at 4 months post-enrollment||1.10|0.57|0.16
72507648|NCT02078713|144547126|SUPERIORITY||Odds Ratio (OR)|1.45||||0.03|TWO_SIDED|95.0|1.03|2.05||P-value calculated in multiply imputed dataset|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|||2.05|1.03|0.03
72507649|NCT02078713|144547127|SUPERIORITY||Odds Ratio (OR)|1.61||||0.01|TWO_SIDED|95.0|1.11|2.33||P-value calculated in imputed dataset|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|||2.33|1.11|0.01
72399044|NCT03274687|144304518|NON_INFERIORITY|The non-inferiority margin for the difference in mean change score (∆2 - ∆1) is -5.||||||0.98|||||||t-test, 1 sided|||Null hypothesis (H0): mean change score of HYPORT (∆2) is worse than that of COPORT (∆1), specifically ∆2 - ∆1 \< -5. Alternative hypothesis (HA): ∆2 is not worse than ∆1, specifically ∆2 - ∆1 ≥ -5. The study sample size is based on 90% power for this endpoint and 91% power for the bowel endpoint (resulting in 81.9% statistical power to reject the null hypothesis for both endpoints) and a one-sided alpha=0.025 with an overall type I error of 0.05 with a Bonferroni adjustment.||||0.98
72399045|NCT03274687|144304519|NON_INFERIORITY|The non-inferiority margin for the difference in mean change score (∆2 - ∆1) is -6.||||||0.96|||||||t-test, 1 sided|||Null hypothesis (H0): mean change score of HYPORT (∆2) is worse than that of COPORT (∆1), specifically ∆2 - ∆1 \< -5. Alternative hypothesis (HA): ∆2 is not worse than ∆1, specifically ∆2 - ∆1 ≥ -5. The study sample size is based on 91% power for this endpoint and 90% power for the urinary endpoint (resulting in 81.9% statistical power to reject the null hypothesis for both endpoints) and a one-sided alpha=0.025 with an overall type I error of 0.05 with a Bonferroni adjustment.||||0.96
72399046|NCT03274687|144304520|SUPERIORITY|||||||0.7|||||||t-test, 2 sided|||End of RT||||0.70
72475724|NCT01247285|144476908|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|107.81|||||TWO_SIDED|90.0|97.37|119.38|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||119.38|97.37|
72475725|NCT01247285|144476909|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|100.69|||||TWO_SIDED|90.0|92.9|109.14|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||109.14|92.90|
72475726|NCT01247285|144476910|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|100.77|||||TWO_SIDED|90.0|93.53|108.56|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||108.56|93.53|
72507650|NCT02078713|144547128|SUPERIORITY||Odds Ratio (OR)|1.11||||0.62|TWO_SIDED|95.0|0.74|1.67||P-value calculated in multiply imputed dataset|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|||1.67|0.74|0.62
72507651|NCT02078713|144547129|SUPERIORITY||Relative risk ratio|1.1||||0.85|TWO_SIDED|95.0|0.4|3.04||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The estimation value represents the relative risk of the outcome in the intervention group, compared to relative risk in the control group.|Comparison of patients who wished provider had been less involved to right amount (ref)||3.04|0.40|0.85
72399047|NCT03274687|144304520|SUPERIORITY|||||||0.67|||||||t-test, 2 sided|||6 months||||0.67
72399048|NCT03274687|144304520|SUPERIORITY|||||||0.66|||||||t-test, 2 sided|||1 year||||0.66
72399049|NCT03274687|144304521|SUPERIORITY|||||||0.0011|||||||t-test, 2 sided|||End of RT||||0.0011
72399050|NCT03274687|144304521|SUPERIORITY|||||||0.93|||||||t-test, 2 sided|||6 months||||0.93
72399051|NCT03274687|144304521|SUPERIORITY|||||||0.3|||||||t-test, 2 sided|||1 year||||0.30
72399052|NCT03274687|144304522|SUPERIORITY|||||||0.29|||||||Gray's test|Two-sided significance level 0.05||Protocol definition of biochemical failure||||0.29
72399053|NCT03274687|144304522|SUPERIORITY|||||||0.22|||||||Gray's test|Two-sided significance level 0.05||Phoenix definition of biochemical failure||||0.22
72399054|NCT03274687|144304523|SUPERIORITY|||||||0.96||||||Two-sided significance level 0.05|Gray's test|||||||0.96
72399055|NCT03274687|144304524|SUPERIORITY|||||||0.35||||||Two-sided significance level 0.05|Gray's test|||||||0.35
72399056|NCT03274687|144304525|SUPERIORITY|||||||0.41||||||Two-sided significance level 0.05|Gray's test|||||||0.41
72399057|NCT03274687|144304526|SUPERIORITY|||||||0.6||||||Two-sided significance level 0.05|Gray's test|||||||0.60
72399058|NCT03274687|144304528|SUPERIORITY||Hazard Ratio (HR)|1.58||||0.61|TWO_SIDED|95.0|0.26|9.47||Two-side significance level 0.05|Log Rank||Reference = COPORT|||9.47|0.26|0.61
72399059|NCT03274687|144304529|SUPERIORITY|||||||0.53|||||||Chi-squared|||Patients with any grade 3 or higher adverse event of any attribution||||0.53
72399060|NCT03274687|144304529|SUPERIORITY|||||||0.6929|||||||Chi-squared|||Patients with any grade 3 or higher gastrointestinal adverse event of any attribution||||0.6929
72399061|NCT03274687|144304529|SUPERIORITY|||||||0.2605|||||||Chi-squared|||Patients with any grade 3 or higher genitourinary adverse event of any attribution||||0.2605
72507652|NCT02078713|144547129|SUPERIORITY||Relative risk ratio|1.6||||0.24|TWO_SIDED|95.0|0.73|3.5||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The estimation value represents the relative risk of the outcome in the intervention group, compared to relative risk in the control group.|Comparison of patients who reported they wished their providers had been more involved, compared to right amount (ref)||3.50|0.73|0.24
72507653|NCT02078713|144547130|SUPERIORITY||Relative risk ratio|1.0||||0.997|TWO_SIDED|95.0|0.45|2.25||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The estimation value represents the relative risk of the outcome in the intervention group, compared to relative risk in the control group.|Comparison of patients who wished provider had expressed preference less strongly to right amount (ref).||2.25|0.45|0.997
72507654|NCT02078713|144547130|SUPERIORITY||Relative risk ratio|0.69||||0.16|TWO_SIDED|95.0|0.41|1.16||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The estimation value represents the relative risk of the outcome in the intervention group, compared to relative risk in the control group.|Comparison of patients who reported they wished provider had expressed preference more strongly, compared to right amount (ref).||1.16|0.41|0.16
72507655|NCT02078713|144547131|SUPERIORITY|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|Odds Ratio (OR)|1.3||||0.13|TWO_SIDED|95.0|0.93|1.82||P-value calculated in multiply imputed dataset.|Regression, Logistic||The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|||1.82|0.93|0.13
72507656|NCT02078713|144547132|SUPERIORITY||Relative risk ratio|1.13||||0.5|TWO_SIDED|95.0|0.79|1.61||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The estimation value represents the relative risk of the outcome in the intervention group, compared to relative risk in the control group.|Comparison of patient decision to both (ref)||1.61|0.79|0.50
72507657|NCT02078713|144547132|SUPERIORITY||Relative risk ratio|2.14||||0.09|TWO_SIDED|95.0|0.89|5.15||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The estimation value represents the relative risk of the outcome in the intervention group, compared to relative risk in the control group.|Comparison of provider decision to both (ref)||5.15|0.89|0.09
72507658|NCT02078713|144547133|SUPERIORITY||Odds Ratio (OR)|1.27||||0.12|TWO_SIDED|95.0|0.94|1.71||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|||1.71|0.94|0.12
72507659|NCT02078713|144547134|SUPERIORITY||Odds Ratio (OR)|1.18||||0.41|TWO_SIDED|95.0|0.8|1.74||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison of overall score||1.74|0.80|0.41
72507660|NCT02078713|144547134|SUPERIORITY||Odds Ratio (OR)|1.34||||0.0496|TWO_SIDED|95.0|1.0|1.8|||Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison of informed decision subscale||1.80|1.00|0.0496
72507661|NCT02078713|144547134|SUPERIORITY||Odds Ratio (OR)|1.45||||0.03|TWO_SIDED|95.0|1.03|2.05||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison of uncertainty subscale of DCS||2.05|1.03|0.03
72507662|NCT02078713|144547134|SUPERIORITY||Odds Ratio (OR)|1.13||||0.5|TWO_SIDED|95.0|0.8|1.59||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison of effective decision subscale||1.59|0.80|0.5
72507663|NCT02078713|144547134|SUPERIORITY||Odds Ratio (OR)|1.17||||0.31|TWO_SIDED|95.0|0.86|1.59||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison of values clarity subscale||1.59|0.86|0.31
72507664|NCT02078713|144547134|SUPERIORITY||Odds Ratio (OR)|1.06||||0.73|TWO_SIDED|95.0|0.76|1.49||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison of support subscale||1.49|0.76|0.73
72507665|NCT02078713|144547135|SUPERIORITY||Odds Ratio (OR)|1.27||||0.12|TWO_SIDED|95.0|0.94|1.72||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison of correct knowledge - pills are more effective than condoms||1.72|0.94|0.12
72507666|NCT02078713|144547135|SUPERIORITY||Odds Ratio (OR)|2.65|||<|0.0001|TWO_SIDED|95.0|1.94|3.62||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison of correct knowledge - IUDs are more effective than pills||3.62|1.94|<0.0001
72507667|NCT02078713|144547135|SUPERIORITY||Odds Ratio (OR)|1.77||||0.0004|TWO_SIDED|95.0|1.29|2.44||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison of correct knowledge - depo is more effective than condoms||2.44|1.29|0.0004
72507668|NCT02078713|144547135|SUPERIORITY||Odds Ratio (OR)|1.92||||0.0002|TWO_SIDED|95.0|1.36|2.71||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison of correct knowledge - IUDs are an option for nulliparous young women||2.71|1.36|0.0002
72507669|NCT02078713|144547135|SUPERIORITY||Odds Ratio (OR)|1.86||||0.001|TWO_SIDED|95.0|1.28|2.71||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison of correct knowledge - Methods causing periods to stop are safe.||2.71|1.28|0.001
72507670|NCT02078713|144547135|SUPERIORITY||Odds Ratio (OR)|1.15||||0.36|TWO_SIDED|95.0|0.85|1.57||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison of correct knowledge - LARC can be removed early||1.57|0.85|0.36
72507671|NCT02078713|144547135|SUPERIORITY||Odds Ratio (OR)|2.76|||<|0.0001|TWO_SIDED|95.0|1.72|4.41||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison of knowledge - Copper IUD can act as EC||4.41|1.72|<0.0001
72507672|NCT02078713|144547135|SUPERIORITY||Odds Ratio (OR)|0.77||||0.49|TWO_SIDED|95.0|0.36|1.63||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a regression model in a multiply imputed dataset. This outcome was not adjusted for site due to model being unable to run with imputed data.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison of knowledge - After sex, there is something you can do to prevent pregnancy||1.63|0.36|0.49
72507673|NCT02078713|144547135|SUPERIORITY||Odds Ratio (OR)|0.73||||0.31|TWO_SIDED|95.0|0.39|1.34||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a regression model in a multiply imputed dataset. This outcome was not adjusted for site due to model being unable to run with imputed data.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison of knowledge - EC can prevent pregnancy after sex||1.34|0.39|0.31
72623182|NCT03977155|144777031|SUPERIORITY|Individual BOS-589 dose levels versus placebo were only to be tested if pooled BOS-589 doses versus placebo was significant at p\<0.05.|Mean Difference (Net)|-0.31|STANDARD_ERROR_OF_MEAN|0.35||0.3776|TWO_SIDED|95.0|-1.0|0.38|||t test|P-values were calculated from the independent two-sample t test with equal variance.||Statistical Analysis 1||0.38|-1.00|0.3776
72399071|NCT00594997|144304604|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||p\<0.05 threshold for statistical significance|Regression, Linear|||||||<0.0001
72475727|NCT01247285|144476911|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|104.88|||||TWO_SIDED|90.0|98.53|111.64|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||111.64|98.53|
72475728|NCT01247285|144476912|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|105.64|||||TWO_SIDED|90.0|99.97|111.56|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||111.56|99.97|
72475729|NCT01247285|144476913|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|101.05|||||TWO_SIDED|90.0|94.76|107.77|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||107.77|94.76|
72475730|NCT01141647|144476914|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.56|||||TWO_SIDED|90.0|1.8|7.07||||||||7.07|1.80|
72475731|NCT00858364|144476949|NON_INFERIORITY|Non-inferiority was declared if the upper confidence limit for the hazard ratio (darbepoetin alfa to placebo) was less than 1.15 using a 1-sided significance level of 0.025.|Hazard Ratio (HR)|0.92|||||TWO_SIDED|95.0|0.83|1.01|||||A hazard ratio \< 1.0 indicates a lower risk of death for darbepoetin alfa relative to placebo.|The primary analysis used the Cox Proportional Hazard Model stratified by the randomization stratification factors (geographic region, histology, and screening hemoglobin), with treatment group as the only covariate.||1.01|0.83|
72507674|NCT02078713|144547135|SUPERIORITY||Odds Ratio (OR)|1.33||||0.08|TWO_SIDED|95.0|0.96|1.84||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison of correct knowledge - pill does not affect fertility||1.84|0.96|0.08
72475732|NCT00858364|144476949|NON_INFERIORITY|Non-inferiority was declared if the upper confidence limit for the hazard ratio (darbepoetin alfa to placebo) was less than 1.15 using a 1-sided significance level of 0.025.|Hazard Ratio (HR)|0.91|||||TWO_SIDED|95.0|0.83|1.0|||||A hazard ratio \< 1.0 indicates a lower risk of death for darbepoetin alfa relative to placebo.|As a sensitivity analysis, an unstratified Cox Proportional Hazard Model with treatment group as the only covariate was conducted.||1.00|0.83|
72475733|NCT00858364|144476949|SUPERIORITY|If non-inferiority was demonstrated for both OS and PFS and superiority was demonstrated for the transfusion endpoint, superiority was then tested for both OS and PFS using the Hochberg procedure to adjust for multiplicity.||||||0.07|||||||Stratified log-rank test|Stratified by the randomization stratification factors (geographic region, histology, screening hemoglobin)||||||0.070
72475734|NCT00858364|144476949|SUPERIORITY|||||||0.047|||||||Log Rank|Unstratified log rank test||||||0.047
72475735|NCT00858364|144476949|OTHER||Hazard Ratio (HR)|0.93|||||TWO_SIDED|95.0|0.84|1.02||||||To evaluate the potential effect of cross-in (participants in the placebo group who began treatment with an erythropoiesis-stimulating agent (ESA) at any point after randomization), a sensitivity analysis was conducted that included ESA use as a time-dependent covariate in a Cox regression model stratified by the randomization stratification factors (geographic region, histology, and screening hemoglobin).||1.02|0.84|
72507675|NCT02078713|144547135|SUPERIORITY||Odds Ratio (OR)|1.65||||0.002|TWO_SIDED|95.0|1.2|2.26||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.||Comparison of correct knowledge - patch does not affect fertility|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|2.26|1.2|0.002
72507676|NCT02078713|144547135|SUPERIORITY||Odds Ratio (OR)|1.7||||0.002|TWO_SIDED|95.0|1.23|2.35||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison of correct knowledge - ring does not affect fertility||2.35|1.23|0.002
72507677|NCT02078713|144547135|SUPERIORITY||Odds Ratio (OR)|0.94||||0.77|TWO_SIDED|95.0|0.62|1.43||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison of correct knowledge - Depo does affect fertility||1.43|0.62|0.77
72507678|NCT02078713|144547135|SUPERIORITY||Odds Ratio (OR)|1.61||||0.002|TWO_SIDED|95.0|1.19|2.17||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison of correct knowledge - Hormonal IUD does not affect fertility||2.17|1.19|0.002
72399088|NCT05104476|144304677|SUPERIORITY||Bayesian Progression Model|0.81|||||TWO_SIDED|95.0|0.56|1.13|||||Reported here is the estimated effect parameter from the Bayesian Progression Model and the associated Credibility Interval for the active arm.|||1.13|0.56|
72475736|NCT00858364|144476950|NON_INFERIORITY|If non-inferiority was declared for OS, non-inferiority would be declared for PFS if the upper confidence limit for the hazard ratio was less than 1.15 using a 1-sided significance level of 0.025.|Hazard Ratio (HR)|0.95|||||TWO_SIDED|95.0|0.87|1.04|||||A hazard ratio \< 1.0 indicates a lower risk of death or progression for darbepoetin alfa relative to placebo.|The primary analysis of PFS used a Cox Proportional Hazard Model stratified by the randomization stratification factors (geographic region, histology, and screening hemoglobin), with treatment group as the only covariate.||1.04|0.87|
72475737|NCT00858364|144476950|NON_INFERIORITY|If non-inferiority was declared for OS, non-inferiority would be declared for PFS if the upper confidence limit for the hazard ratio was less than 1.15 using a 1-sided significance level of 0.025.|Hazard Ratio (HR)|0.95|||||TWO_SIDED|95.0|0.87|1.04|||||A hazard ratio \< 1.0 indicates a lower risk of death or progression for darbepoetin alfa relative to placebo.|As a sensitivity analysis, an unstratified Cox Proportional Hazard Model with treatment group as the only covariate was conducted.||1.04|0.87|
72475738|NCT00858364|144476950|SUPERIORITY|If non-inferiority was demonstrated for both OS and PFS and superiority was demonstrated for the transfusion endpoint, superiority was then tested for both OS and PFS using the Hochberg procedure to adjust for multiplicity.||||||0.31|||||||Stratified log-rank test|Stratified by the randomization stratification factors (geographic region, histology, screening hemoglobin).||||||0.31
72475739|NCT00858364|144476950|SUPERIORITY|||||||0.27|||||||Log Rank|Unstratified log rank test||||||0.27
72475740|NCT00858364|144476950|OTHER||Hazard Ratio (HR)|0.96|||||TWO_SIDED|95.0|0.88|1.05||||||To evaluate the potential effect of cross-in (participants in the placebo group who began treatment with an erythropoiesis-stimulating agent (ESA) at any point after randomization), a sensitivity analysis was conducted that included ESA use as a time-dependent covariate in a Cox regression model stratified by the randomization stratification factors (geographic region, histology, and screening hemoglobin).||1.05|0.88|
72507679|NCT02078713|144547135|SUPERIORITY||Odds Ratio (OR)|1.56||||0.004|TWO_SIDED|95.0|1.15|2.1||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison of correct knowledge - Non-hormonal IUD does not affect fertility||2.1|1.15|0.004
72475741|NCT00858364|144476951|SUPERIORITY|If non-inferiority was declared for OS and PFS, superiority would be declared for the transfusion endpoint if the p-value from a two-sided test of significance using the Cochran-Mantel-Haenszel method was less than 0.05 in favor of the darbepoetin alfa group.|Odds Ratio (OR)|0.704|||<|0.001|TWO_SIDED|95.0|0.573|0.864|||Cochran-Mantel-Haenszel||An odds ratio \< 1.0 indicates a lower event rate for darbepoetin alfa relative to placebo.|The primary analysis of the incidence of a transfusion or hemoglobin ≤ 8.0 g/dL from day 29 to EOETP was based on the Cochran-Mantel-Haenszel method to test for treatment group differences while adjusting for the randomization stratification factors (geographic region, histology, and screening hemoglobin).||0.864|0.573|< 0.001
72475742|NCT00858364|144476951|OTHER||Odds Ratio (OR)|0.705|||<|0.001|TWO_SIDED|95.0|0.574|0.866|||Regression, Logistic||An odds ratio \< 1.0 indicates a lower event rate for darbepoetin alfa relative to placebo.|As a sensitivity analysis a logistic regression analysis was conducted, stratified by the randomization stratification factors (geographic region, histology, screening hemoglobin).||0.866|0.574|< 0.001
72475743|NCT00858364|144476953|OTHER||Odds Ratio (OR)|1.173||||0.076|TWO_SIDED|95.0|0.983|1.401|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel method adjusted for the randomization stratification factors (geographic region, histology, screening hemoglobin).|An odds ratio \< 1.0 indicates a lower event rate for darbepoetin alfa relative to placebo.|||1.401|0.983|0.076
72507680|NCT02078713|144547135|SUPERIORITY||Odds Ratio (OR)|1.54||||0.005|TWO_SIDED|95.0|1.14|2.07||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison of correct knowledge - Implant does not affect fertility||2.07|1.14|0.005
72507681|NCT02078713|144547135|SUPERIORITY||Odds Ratio (OR)|2.47|||<|0.0001|TWO_SIDED|95.0|1.75|3.49||P-value calculated in multiply imputed dataset.|Regression, Logistic||OR calculated in multiply imputed dataset. Intervention patients had 2.47 times the odds of control patients to give correct answer.|Comparison of correct knowledge - composite IUD knowledge item (all correct responses on items related to IUD knowledge, versus any incorrect)||3.49|1.75|<0.0001
72507682|NCT02078713|144547136|SUPERIORITY||Odds Ratio (OR)|1.19||||0.25|TWO_SIDED|95.0|0.88|1.61||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison of percentage of patients giving top score at baseline||1.61|0.88|0.25
72507683|NCT02078713|144547136|SUPERIORITY||Odds Ratio (OR)|0.9||||0.5|TWO_SIDED|95.0|0.66|1.22||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention groups in the numerator over the odds of the control group in the denominator.|Comparison of percentage of patients giving top score at 4 months post-enrollment||1.22|0.66|0.5
72623183|NCT03977155|144777031|SUPERIORITY||Mean Difference (Net)|0.04|STANDARD_ERROR_OF_MEAN|0.39|||TWO_SIDED|95.0|-0.73|0.82||||||Statistical Analysis 2||0.82|-0.73|
72475744|NCT00858364|144476953|OTHER||Odds Ratio (OR)|1.173||||0.078|TWO_SIDED|95.0|0.982|1.401|||Cochran-Mantel-Haenszel|Unstratified analysis||||1.401|0.982|0.078
72475745|NCT00858364|144476955|OTHER||Odds Ratio (OR)|0.741||||0.003|TWO_SIDED|95.0|0.61|0.901|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel method adjusted for the randomization stratification factors (geographic region, histology, screening hemoglobin).|An odds ratio \< 1.0 indicates a lower event rate for darbepoetin alfa relative to placebo.|||0.901|0.610|0.003
72475746|NCT00858364|144476955|OTHER||Odds Ratio (OR)|0.758||||0.003|TWO_SIDED|95.0|0.63|0.913|||Cochran-Mantel-Haenszel|Unstratified analysis||||0.913|0.630|0.003
72623184|NCT03977155|144777031|SUPERIORITY||Mean Difference (Net)|-0.61|STANDARD_ERROR_OF_MEAN|0.403|||TWO_SIDED|95.0|-1.41|0.19||||||Statistical Analysis 3||0.19|-1.41|
72507684|NCT02078713|144547136|SUPERIORITY||Odds Ratio (OR)|0.83||||0.23|TWO_SIDED|95.0|0.6|1.13||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison of percentage of patients giving a top score on the 5-point Likert scale at 7 months post-enrollment.||1.13|0.60|0.23
72507685|NCT02078713|144547137|SUPERIORITY||Odds Ratio (OR)|0.91||||0.55|TWO_SIDED|95.0|0.66|1.25||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|||1.25|0.66|0.55
72507686|NCT02078713|144547138|SUPERIORITY||Odds Ratio (OR)|1.22||||0.13|TWO_SIDED|95.0|0.92|1.6||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison of rating for hormonal IUD. Patients excluded from analysis if they had not heard of hormonal IUD.||1.6|0.92|0.13
72507687|NCT02078713|144547138|SUPERIORITY||Odds Ratio (OR)|0.99||||0.92|TWO_SIDED|95.0|0.75|1.3||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison of rating on non-hormonal IUD. Patients were excluded from this analysis if they reported not having heard of the non-hormonal IUD in the post-visit survey.||1.3|0.75|0.92
72507688|NCT02078713|144547138|SUPERIORITY||Odds Ratio (OR)|0.85||||0.17|TWO_SIDED|95.0|0.67|1.07||P-value calculated in multiply imputed dataset|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison of rating of implant||1.07|0.67|0.17
72507689|NCT02078713|144547138|SUPERIORITY||Odds Ratio (OR)|0.71||||0.009|TWO_SIDED|95.0|0.54|0.92||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison of rating on condoms. Patients were excluded from this analysis if they reported not having heard of condoms in the post-visit survey.||0.92|0.54|0.009
72566248|NCT00680186|144663142|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.04||||0.8939||95.0|0.61|1.77|||Regression, Cox|Patients without events are censored at the end of ptp.||HR vs. Warfarin (events occurring between randomisation and end of ptp). The time to first occurrence of the endpoint was compared between treatment groups using the Cox PH model, including the factors treatment, active cancer at baseline, symptomatic PE at baseline, and the interaction between active cancer and symptomatic PE.||1.77|0.61|0.8939
72475747|NCT01680640|144477012|SUPERIORITY||Mean Difference (Net)|-3.8|STANDARD_DEVIATION|0.8|=|0.05|TWO_SIDED|95.0||||The threshold for statistical significance was p=0.05|Regression, Linear|||A total sample size of 100 participants, with a 14% drop out during the study and 43 participants in each group completing the study provided 85% power to detect a difference of 40% in liver fat (in the treatment arm compared with the placebo), using a power calculation test with a 0.05 two-sided significance level. For change in liver fat percentage (and other secondary outcomes), ANCOVA will also be undertaken to assess effect sizes in the intervention group and placebo.||||=0.05
72475748|NCT01680640|144477012|SUPERIORITY|For each primary outcome, a change variable was calculated as the difference between end of study and baseline measurements. Multiple regression analysis was used to assess the effect of synbiotic treatment on each of the change variables of interest.|Median Difference (Final Values)|-1.7|||<|0.001|TWO_SIDED||||||Regression, Linear|||||||<0.001
72475749|NCT01680640|144477013|SUPERIORITY|For each primary outcome, a change variable was calculated as the difference between end-of study and baseline measurements. Multiple regression analysis was used to assess the effect of synbiotic treatment on each of the change variables of interest.|Mean Difference (Final Values)|0.1||||1|TWO_SIDED||||||Regression, Linear|||||||1.00
72475750|NCT01680640|144477014|SUPERIORITY|For each primary outcome, a change variable was calculated as the difference between end of study and baseline measurements. Multiple regression analysis was used to assess the effect of synbiotic treatment on each of the change variables of interest.|Mean Difference (Final Values)|0.2||||0.8|TWO_SIDED||||||Regression, Linear|||||||0.80
72475751|NCT01680640|144477015|SUPERIORITY|For each primary outcome, a change variable was calculated as the difference between end of study and baseline measurements. Multiple regression analysis was used to assess the effect of synbiotic treatment on each of the change variables of interest.|Median Difference (Final Values)|0.97|||<|0.001|TWO_SIDED||||||Beta-diversity indexes|Beta-diversity indexes were first visualized through a Principal Coordinates Analysis (PCoA)||||||<0.001
72507690|NCT02078713|144547138|SUPERIORITY||Odds Ratio (OR)|0.86||||0.26|TWO_SIDED|95.0|0.65|1.12||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison of rating on the shot (Depo Provera). Patients were excluded from this analysis if they reported not having heard of the the shot (Depo Provera) in the post-visit survey.||1.12|0.65|0.26
72507691|NCT02078713|144547138|SUPERIORITY||Odds Ratio (OR)|0.85||||0.23|TWO_SIDED|95.0|0.64|1.11||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison of rating on the pill. Patients were excluded from this analysis if they reported not having heard of the pill in the post-visit survey.||1.11|0.64|0.23
72507692|NCT02078713|144547138|SUPERIORITY||Odds Ratio (OR)|0.92||||0.55|TWO_SIDED|95.0|0.69|1.22||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison of rating on the patch. Patients were excluded from this analysis if they reported not having heard of the patch in the post-visit survey.||1.22|0.69|0.55
72507693|NCT02078713|144547138|SUPERIORITY||Odds Ratio (OR)|0.97||||0.84|TWO_SIDED|95.0|0.76|1.25||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison of rating on the pull-out method. Patients were excluded from this analysis if they reported not having heard of the pull-out method in the post-visit survey.||1.25|0.76|0.84
72507694|NCT02078713|144547138|SUPERIORITY||Odds Ratio (OR)|0.81||||0.07|TWO_SIDED|95.0|0.64|1.02||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison of rating on the ring. Patients were excluded from this analysis if they reported not having heard of the ring in the post-visit survey.||1.02|0.64|0.07
72507695|NCT02078713|144547138|SUPERIORITY||Odds Ratio (OR)|0.59||||0.002|TWO_SIDED|95.0|0.42|0.82||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison of rating on female sterilization/tubal ligation. Patients were excluded from this analysis if they reported not having heard of female sterilization/tubal ligation in the post-visit survey.||0.82|0.42|0.002
72507696|NCT02078713|144547138|SUPERIORITY||Odds Ratio (OR)|0.58||||0.005|TWO_SIDED|95.0|0.4|0.85||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison of rating on male sterilization/vasectomy. Patients were excluded from this analysis if they reported not having heard of male sterilization/vasectomy in the post-visit survey.||0.85|0.4|0.005
72507697|NCT02078713|144547139|SUPERIORITY||Odds Ratio (OR)|1.55||||0.27|TWO_SIDED|95.0|0.71|3.42||P-value calculated in multiply imputed dataset|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison of patients who newly heard of hormonal IUD||3.42|0.71|0.27
72507698|NCT02078713|144547139|SUPERIORITY||Odds Ratio (OR)|1.65||||0.18|TWO_SIDED|95.0|0.8|3.4||P-value calculated in multiply imputed dataset|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison of patients who newly heard of non-hormonal IUD||3.40|0.80|0.18
72507699|NCT02078713|144547139|SUPERIORITY||Odds Ratio (OR)|1.29||||0.5|TWO_SIDED|95.0|0.62|2.69||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison of patients who newly heard of implant||2.69|0.62|0.5
72507700|NCT02078713|144547139|SUPERIORITY||Odds Ratio (OR)|1.7||||0.32|TWO_SIDED|95.0|0.59|4.89||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison of patients who newly heard of the patch||4.89|0.59|0.32
72507701|NCT02078713|144547139|SUPERIORITY||Odds Ratio (OR)|1.38||||0.37|TWO_SIDED|95.0|0.68|2.81||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison of patients who newly heard of ring||2.81|0.68|0.37
72475752|NCT00738894|144477023|SUPERIORITY|This is the first of two primary outcomes for this study. Assumptions for power calculations: expected event free for medical management 92% at 24 months; expected event free for device closure 96.4% at 24 months (55% risk reduction); 664 subjects randomly assigned 2:1 to device closure or medical management provides 80% power with 15% attrition (over 5 years) and 1-sided alpha = 0.024 to allow for interim analysis (interim analysis later rescinded from plan).|Hazard Ratio (HR)|0.23||||0.001|TWO_SIDED|95.0|0.09|0.62||1-sided p-value was adjusted for multiplicity with 2nd primary outcome using Dubey and Armitage-Parmer (D/AP) procedure.|Log Rank||Hazard ratio (test/control) obtained from Cox proportional hazards model with treatment arm as sole explanatory variable, the exponentiated coefficient of which provided the hazard ratio. Unadjusted for multiplicity.|"Test null hypothesis of equal or lower recurrent stroke-free survivorship for device closure compared to medical management.~H0: Sd(t) ≤ Sm(t) for all t, versus H1: Sd(t) \> Sm(t) for all t, where Sd(t) and Sm(t) are true Kaplan-Meier product-limit survivor functions for the device closure and medical management arms and t is time from randomization to event or censoring.~Event-free subjects were censored at time of last follow-up. Significance threshold (1-sided alpha) = 0.025."||0.62|0.09|0.001
72475753|NCT00738894|144477024|SUPERIORITY|This is the second of two primary outcomes for this study. Assumptions for power calculations: expected proportion of brain infarct is 3-7 times the clinical stroke rate; expected brain infarct proportion for medical management 14.5% (2.9% clinical stroke x 5); expected brain infarct for device closure 6.5% (55% risk reduction); 597 subjects (10% attrition from 664) provides 73% power with 1-sided alpha = 0.0125 (based conservatively on a Bonferroni adjustment of alpha/2).|Risk Difference (RD)|0.056||||0.024|TWO_SIDED|95.0|0.003|0.108||1-sided p-value was adjusted for multiplicity with 1st primary outcome using Dubey and Armitage-Parmer (D/AP) procedure.|z-test, 1-sided||Unadjusted for multiplicity.|"Test null hypothesis of equal or higher proportion with brain infarct for device closure compared to medical management.~H0: Pm - Pd ≤ 0, versus H1: Pm - Pd \> 0, where Pd and Pm are true proportions of subjects with brain infarct for the device closure and medical management arms.~Significance threshold (1-sided alpha) = 0.025."||0.108|0.003|0.024
72475754|NCT00719329|144477027|SUPERIORITY_OR_OTHER||Prevalence Rate Ratio|0.75|||||TWO_SIDED|95.0|0.7|0.81|||Binomial Regression, Log Link|General Estimating Equations (GEE) to account for clustered allocation|Prevalence Rate Ratio - Comparing Single CHX Cleansing to Dry Cord Care|Comparison of colonization prevalence, relative to dry cord care group||0.81|0.70|
72475755|NCT00719329|144477027|SUPERIORITY_OR_OTHER||Prevalence Rate Ratio|0.71|||||TWO_SIDED|95.0|0.66|0.77|||Binomial Regression, Log Link|General Estimating Equations (GEE) to account for clustered allocation|Prevalence Rate Ratio - Comparing Multiple CHX Cleansing to Dry Cord Care|Comparison of colonization prevalence, relative to dry cord care group||0.77|0.66|
72475756|NCT00719329|144477028|SUPERIORITY_OR_OTHER||Prevalence Rate Ratio|0.78|||||TWO_SIDED|95.0|0.74|0.82|||Binomial Regression, Log Link|Generalized Estimating Equations to account for clustered allocation|Prevalence Ratio Ratio - Comparing Single Cleansing to Dry Cord Care|Comparison of colonization prevalence, relative to dry cord care group||0.82|0.74|
72475757|NCT00719329|144477028|SUPERIORITY_OR_OTHER||Prevalence Rate Ratio|0.61|||||TWO_SIDED|95.0|0.57|0.65|||Binomial Regression, Log Link|Generalized Estimating Equations to account for clustered allocation|Prevalence Rate Ratio - Comparing Multiple Cleansing to Dry Cord Care|Comparison of colonization prevalence, relative to dry cord care group||0.65|0.57|
72475758|NCT00719329|144477029|SUPERIORITY_OR_OTHER||Prevalence Rate Ratio|0.92|||||TWO_SIDED|95.0|0.89|0.96|||Binomial Regression, Log Link|General Estimating Equations to adjust for clustered allocation|Prevalence Rate Ratio - Comparing Single Cleansing to Dry Cord Care|Comparison of colonization prevalence, relative to dry cord care group||0.96|0.89|
72475759|NCT00719329|144477029|SUPERIORITY_OR_OTHER||Prevalence Rate Ratio|0.57|||||TWO_SIDED|95.0|0.53|0.63|||Binomial Regression, Log Link|General Estimating Equations to account for clustered allocation|Prevalence Ratio Ratio - Comparing Multiple Cleansing to Dry Cord Care|Comparison of colonization prevalence, relative to dry cord care group||0.63|0.53|
72475760|NCT02186600|144477047|OTHER|Hierarchical linear modeling for intent-to-treat analysis to analyze time X group interactions, adjusted for baseline total body lean mass and height.||||||0.7|||||||hierarchical linear modeling|controlled for total lean mass and height||||||0.7
72475761|NCT02186600|144477048|OTHER|hierarchical linear modeling||||||0.01|||||||hierarchical linear modeling|||||||0.01
72475762|NCT02186600|144477049|OTHER|Hierarchical linear modeling|||||<|0.007|||||||hierarchical linear modeling|||||||<0.007
72475763|NCT03026075|144477050|SUPERIORITY||||||<|0.01|||||||McNemar|||"The primary objective of the study is to evaluate the effectiveness of MCS in cleansing a poorly prepared colon.~A sample size of 47 patients is required as per a McNemar test to determine that the paired discordant proportions are significantly different under the followings assumptions:~Probability of Type I Error (α) = 0.05, Power (1 - β) = 0.8 Proportion switching from + to - = 0, Proportion switching from - to + = 0.6 Potential of dropout 10% (i.e. 4 cases)"||||<0.01
72475764|NCT03798691|144477103|SUPERIORITY|||||||0.16|||||||Mann-Whitney U test|||one month after series completion of two dose series||||0.16
72475765|NCT00611975|144477174|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.8|||||||Mixed Models Analysis|||Blood draws were scheduled for early follicular, ovulatory and luteal phases. Menstrual phase for blood samples were re-assigned to phase based on time to onset of next menstrual period. Early follicular(35-21 days before next menstrual period (NMP)), Ovulatory (16-12 before NMP) luteal (11-3 days before NMP).||||>0.8
72623185|NCT03977155|144777031|SUPERIORITY||Mean Difference (Net)|0.65|STANDARD_ERROR_OF_MEAN|0.397|||TWO_SIDED|95.0|-0.13|1.44||||||Statistical Analysis 4||1.44|-0.13|
72623186|NCT03977155|144777033|SUPERIORITY|Individual BOS-589 dose levels versus placebo were only to be tested if pooled BOS-589 doses versus placebo was significant at p\<0.05.|Mean Difference (Net)|-0.03|STANDARD_ERROR_OF_MEAN|0.211||0.884|TWO_SIDED|95.0|-0.45|0.39|||t test|P-values were calculated from the independent two-sample t test with equal variance.||Statistical Analysis 1||0.39|-0.45|0.8840
72475766|NCT00611975|144477174|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.4|||||||Mixed Models Analysis|||This secondary analysis examined main effect of menstrual cycle phase on hormone levels||||>0.4
72475767|NCT00611975|144477175|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.6|||||||Mixed Models Analysis|||Asex questionnaires were scheduled for early follicular, ovulatory and luteal phases. Menstrual phase for ASEX scores were re-assigned to phase based on time to onset of next menstrual period. Follicular(35-21 days before next menstrual period (NMP)), Ovulatory (16-12 before NMP) luteal (11-2 days before NMP).||||>0.6
72475768|NCT00611975|144477175|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.6|||||||Mixed Models Analysis|||This secondary analysis examined main effect of menstrual cycle phase on ASEX scores||||>0.6
72475769|NCT00611975|144477176|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.01|||||||Mixed Models Analysis|||Blood draws were scheduled for early follicular, ovulatory and luteal phases. Menstrual phase for blood samples were re-assigned to phase based on time to onset of next menstrual period. Early follicular(35-21 days before next menstrual period (NMP)), Ovulatory (16-12 before NMP) luteal (11-3 days before NMP).||||<.01
72475770|NCT00611975|144477176|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.01|||||||Mixed Models Analysis|||This secondary analysis examined main effect of menstrual cycle phase on hormone levels||||<0.01
72623187|NCT03977155|144777033|SUPERIORITY||Mean Difference (Net)|-0.1|STANDARD_ERROR_OF_MEAN|0.249|||TWO_SIDED|95.0|-0.6|0.39||||||Statistical Analysis 2||0.39|-0.60|
72623188|NCT03977155|144777033|SUPERIORITY||Mean Difference (Net)|0.03|STANDARD_ERROR_OF_MEAN|0.231|||TWO_SIDED|95.0|-0.43|0.49||||||Statistical Analysis 3||0.49|-0.43|
72475771|NCT00611975|144477177|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.4|||||||Mixed Models Analysis|||Blood draws were scheduled for early follicular, ovulatory and luteal phases. Menstrual phase for blood samples were re-assigned to phase based on time to onset of next menstrual period. Early follicular(35-21 days before next menstrual period (NMP)), Ovulatory (16-12 before NMP) luteal (11-3 days before NMP).||||>0.4
72475772|NCT00611975|144477177|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||Mixed Models Analysis|||This secondary analysis examined main effect of menstrual cycle phase on hormone levels||||<.0001
72475773|NCT00611975|144477178|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.7|||||||Mixed Models Analysis|||Blood draws were scheduled for early follicular, ovulatory and luteal phases. Menstrual phase for blood samples were re-assigned to phase based on time to onset of next menstrual period. Early follicular(35-21 days before next menstrual period (NMP)), Ovulatory (16-12 before NMP) luteal (11-3 days before NMP).||||>0.7
72475774|NCT00611975|144477178|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||Mixed Models Analysis|||This secondary analysis examined main effect of menstrual cycle phase on hormone levels||||<.0001
72475775|NCT00611975|144477179|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.9|||||||Mixed Models Analysis|||Blood draws were scheduled for early follicular, ovulatory and luteal phases. Menstrual phase for blood samples were re-assigned to phase based on time to onset of next menstrual period. Early follicular(35-21 days before next menstrual period (NMP)), Ovulatory (16-12 before NMP) luteal (11-3 days before NMP).||||>0.9
72475776|NCT00611975|144477179|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||Mixed Models Analysis|||This secondary analysis examined main effect of menstrual cycle phase on hormone levels||||<.0001
72475777|NCT00611975|144477180|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.9|||||||Mixed Models Analysis|||Blood draws were scheduled for early follicular, ovulatory and luteal phases. Menstrual phase for blood samples were re-assigned to phase based on time to onset of next menstrual period. Early follicular(35-21 days before next menstrual period (NMP)), Ovulatory (16-12 before NMP) luteal (11-3 days before NMP).||||>0.9
72475778|NCT00611975|144477180|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.9|||||||Mixed Models Analysis|||This secondary analysis examined main effect of menstrual cycle phase on hormone levels||||>0.9
72475779|NCT00611975|144477181|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.1|||||||Mixed Models Analysis|||Blood draws were scheduled for early follicular, ovulatory and luteal phases. Menstrual phase for blood samples were re-assigned to phase based on time to onset of next menstrual period. Early follicular(35-21 days before next menstrual period (NMP)), Ovulatory (16-12 before NMP) luteal (11-3 days before NMP).||||>0.1
72475780|NCT00611975|144477181|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.7|||||||Mixed Models Analysis|||This secondary analysis examined main effect of menstrual cycle phase on hormone levels||||>0.7
72475781|NCT00700427|144477233|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||Fisher Exact|||||||0.001
72475782|NCT00700427|144477235|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||ANCOVA|||||||0.002
72475783|NCT00700427|144477236|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for ADHD Imputed (Attributed) Index Score.|ANCOVA|||||||<0.001
72475784|NCT00700427|144477236|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||P-value for Hyperactivity/Impulsivity Subscale Imputed Score.|ANCOVA|||||||0.002
72475785|NCT00700427|144477236|SUPERIORITY_OR_OTHER|||||||0.009||95.0||||P-value for Inattention Subscale Imputed Score.|ANCOVA|||||||0.009
72475786|NCT00700427|144477236|SUPERIORITY_OR_OTHER|||||||0.003||95.0||||P-value for Total ADHD Symptom Imputed Score.|ANCOVA|||||||0.003
72475787|NCT00700427|144477237|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for ADHD Imputed (Attributed) Index Score.|ANCOVA|||||||<0.001
72475788|NCT00700427|144477237|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Hyperactivity/Impulsivity Subscale Imputed Score.|ANCOVA|||||||<0.001
72475789|NCT00700427|144477237|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Inattention Subscale Imputed Score.|ANCOVA|||||||<0.001
72475790|NCT00700427|144477237|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Total ADHD Symptom Imputed Score.|ANCOVA|||||||<0.001
72475791|NCT00700427|144477238|SUPERIORITY_OR_OTHER|||||||0.006||95.0|||||ANCOVA|||||||0.006
72475792|NCT00700427|144477239|SUPERIORITY_OR_OTHER|||||||0.006||95.0|||||ANCOVA|||||||0.006
72399118|NCT04008030|144304763|SUPERIORITY|Arm B over Arm A|Hazard Ratio (HR)|0.62||||0.0003|TWO_SIDED|95.0|0.48|0.81||Boundary for statistical significance p-value \< 0.0095.|Log Rank|Log-rank test stratified by the same factors as used in the Cox proportional hazard model.|a Cox Model stratified by tumor sidedness (left vs. right) and prior lines of therapy (0, 1, \>= 2) as entered into the IRT.|||0.81|0.48|0.0003
72399119|NCT04008030|144304764|SUPERIORITY|Arm B over Arm C|Hazard Ratio (HR)|0.21|||<|0.0001|TWO_SIDED|95.0|0.14|0.32||Boundary for statistical significance p-value \< 0.0209.|Log Rank|Log-rank test stratified by the same factors as used in the Cox proportional hazard model.|From a Cox Model stratified by tumor sidedness (left vs. right) as entered into the IRT.|||0.32|0.14|<0.0001
72399120|NCT04008030|144304766|SUPERIORITY|Arm B over Arm A|Hazard Ratio (HR)|0.64|||||TWO_SIDED|95.0|0.52|0.79|||||from a Cox Model stratified by tumor sidedness (left vs. right) and prior lines of therapy (0, 1, \>= 2) as entered into the IRT.|||0.79|0.52|
72399121|NCT04008030|144304767|SUPERIORITY|Arm B over Arm C|Hazard Ratio (HR)|0.32|||||TWO_SIDED|95.0|0.23|0.46|||||From a Cox Model stratified by tumor sidedness (left vs. right) as entered into the IRT.|||0.46|0.23|
72399122|NCT04008030|144304769|SUPERIORITY|Arm B over Arm A|Hazard Ratio (HR)|0.6||||||95.0|0.45|0.8|||||from a Cox proportional hazard model stratified by tumor sidedness (left vs right) and prior lines of therapy (0, 1, ≥ 2) per IRT.|||0.80|0.45|
72399123|NCT04008030|144304770|SUPERIORITY|Arm B over Arm A|Hazard Ratio (HR)|0.63||||||95.0|0.48|0.83|||||from a Cox proportional hazard model stratified by tumor sidedness (left vs right) and prior lines of therapy (0, 1, ≥ 2) per IRT.|||0.83|0.48|
72399124|NCT04008030|144304771|SUPERIORITY|Arm B over Arm C|Hazard Ratio (HR)|0.2||||||95.0|0.12|0.31|||||From a stratified Cox proportional hazard model by tumor sidedness (left vs. right) as entered into the IRT.|||0.31|0.12|
72399125|NCT04008030|144304772|SUPERIORITY|Arm B over Arm C|Hazard Ratio (HR)|0.2||||||95.0|0.12|0.31|||||From a stratified Cox proportional hazard model by tumor sidedness (left vs. right) as entered into the IRT.|||0.31|0.12|
72399126|NCT04008030|144304773|SUPERIORITY|Arm B over Arm A|Hazard Ratio (HR)|0.64||||||95.0|0.52|0.79|||||from a Cox Model stratified by tumor sidedness (left vs. right) and prior lines of therapy (0, 1, \>= 2) as entered into the IRT.|||0.79|0.52|
72399127|NCT04008030|144304774|SUPERIORITY|Arm B over Arm A|Hazard Ratio (HR)|0.62||||||95.0|0.48|0.8|||||Cox Model stratified by tumor sidedness (left vs. right) and prior lines of therapy (0, 1, \>= 2) as entered into the IRT.|||0.80|0.48|
72399128|NCT04008030|144304776|SUPERIORITY|Arm B over Arm A|Odds Ratio (OR)|1.77||||0.0011||95.0|1.26|2.5||Boundary for statistical significance p-value \< 0.006|Cochran-Mantel-Haenszel|Two-sided p-value from stratified CMH Test.|||Stratified by tumor sidedness (left vs. right) and prior lines of therapy (0, 1, \>= 2) as entered into the IRT|2.50|1.26|0.0011
72399129|NCT04008030|144304777|SUPERIORITY|Arm B over Arm C|Odds Ratio (OR)|7.02||||||95.0|3.91|12.62|||||Stratified by tumor sidedness (left vs. right)|||12.62|3.91|
72399130|NCT04008030|144304777|SUPERIORITY|Arm B over Arm A|Odds Ratio (OR)|1.67||||||95.0|1.06|2.63|||||Stratified by tumor sidedness (left vs. right)|||2.63|1.06|
72399131|NCT04008030|144304778|SUPERIORITY|Arm B over Arm A|Hazard Ratio (HR)|0.61|||||TWO_SIDED|95.0|0.45|0.83|||||From a Cox Model stratified by tumor sidedness (left vs. right) and prior lines of therapy (0, 1, \>= 2) as entered into the IRT.|||0.83|0.45|
72623189|NCT03977155|144777033|SUPERIORITY||Mean Difference (Net)|-0.14|STANDARD_ERROR_OF_MEAN|0.247|||TWO_SIDED|95.0|-0.63|0.36||||||Statistical Analysis 4||0.36|-0.63|
72475793|NCT01941719|144477241|EQUIVALENCE|This trial aims to show the enhanced education is no better and no worse than the standard education|Mean Difference (Final Values)|-0.1212||||0.077|TWO_SIDED|||||significance level set at 0.05|ANCOVA|At each follow-up point, multivariate ANCOVA models were used to test for significant changes from the baseline||A mixed-effect model with repeated measures is used to compare the difference of group over time.||||0.0770
72475794|NCT01941719|144477242|EQUIVALENCE|This trial aims to show the new treatment is no better and no worse||||||0.6638||||||The threshold of significance level set at 0.05|Mixed Models Analysis|||||||0.6638
72475795|NCT01941719|144477243|EQUIVALENCE|The test will compare the number of complications between the two groups|||||<|0.05|||||||ANOVA|||||||< 0.05
72475796|NCT01480219|144477244|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.74||||0.042|TWO_SIDED|95.0|1.02|2.96|||Regression, Cox|||Crude hazard ratio (HR) and corresponding 95 percent (%) confidence interval (CI) were calculated using an unadjusted Cox proportional hazards regression model.||2.96|1.02|0.042
72507702|NCT02078713|144547139|SUPERIORITY||Odds Ratio (OR)|1.49||||0.39|TWO_SIDED|95.0|0.6|3.73||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison of patients who newly heard of male sterilization (vasectomy)||3.73|0.60|0.39
72507703|NCT02078713|144547139|SUPERIORITY||Odds Ratio (OR)|1.49||||0.39|TWO_SIDED|95.0|0.6|3.73||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison of patients who newly heard of female sterilization||3.73|0.6|0.39
72507704|NCT02078713|144547140|SUPERIORITY||Odds Ratio (OR)|1.27||||0.18|TWO_SIDED|95.0|0.9|1.81||P-value calculated from multiply imputed dataset|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|"The odds ratio represents the odds of the intervention group rating their appointment as much better, in the numerator, over the odds of the control group giving this rating in the denominator."|Patients excluded from test if they reported not having had a previous contraceptive counseling appointment.||1.81|0.90|0.18
72507705|NCT02078713|144547141|SUPERIORITY||Mean Difference (Final Values)|11.81|||<|0.001|TWO_SIDED|95.0|8.54|18.66||P-value calculated in multiple imputed dataset|Regression, Linear|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The estimation parameter is a beta coefficient from a linear regression model, calculated in an imputed dataset. It represents additional minutes in an intervention visit versus a control visit.|||18.66|8.54|<0.001
72566249|NCT00680186|144663143|SUPERIORITY_OR_OTHER||Risk Difference (Percentage)|-0.3||||0.321|TWO_SIDED|95.0|-1.0|0.3|||Kaplan Meier weighted estimates|||RD vs. Warfarin for Proportion of patients with symptomatic fatal and non-fatal PE at 6 months. Point estimate and 95% CI for the overall RD obtained based on the KM estimates at 6 months (180 days) after adjusting for the stratification factors active cancer at baseline and symptomatic PE at baseline.||0.3|-1.0|0.3210
72475797|NCT01480219|144477244|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.23||||0.453|TWO_SIDED|95.0|0.71|2.14|||Regression, Cox|||HR and corresponding 95% CI were calculated using a parsimoniously adjusted Cox proportional hazards regression model.||2.14|0.71|0.453
72475798|NCT01744392|144477246|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.2||||0.73|TWO_SIDED||||||t-test, 2 sided|||Difference between percentages. Increases in value indicate improvement in adherence.||||.73
72475799|NCT01416389|144477255|SUPERIORITY_OR_OTHER_LEGACY|||||||0.344|||||||t-test, 1 sided|||This measure is compared between two treatment arms using a one-sided t-test. This measure followed a normal distribution.||||0.344
72475800|NCT01416389|144477256|SUPERIORITY_OR_OTHER_LEGACY|||||||0.608|||||||Chi-squared|||||||0.608
72475801|NCT01416389|144477258|SUPERIORITY_OR_OTHER_LEGACY|||||||0.365|||||||Chi-squared|||||||0.365
72475802|NCT03980808|144477267|EQUIVALENCE|A priori significance levels were set to 0.05. As this was a pilot study on a demonstration intervention, power analysis were not performed.|Mean Difference (Net)|1.33|STANDARD_ERROR_OF_MEAN|0.56||0.95|TWO_SIDED||||||ANOVA|Total degrees of freedom (dof) = 17, with between groups dof = 1 and within groups dof = 16.||Composite scores were calculated for the knowledge based tests. Differences in the pre and post test composite scores were compared using ANOVA. We tested the null hypothesis that score changes in the intervention group and control group were the same.||||0.95
72475803|NCT03980808|144477268|EQUIVALENCE|A priori significance levels were set to 0.05. As this was a pilot study on a demonstration intervention, power analysis were not performed.|Mean Difference (Net)|1.03|STANDARD_ERROR_OF_MEAN|0.5376||0.093|TWO_SIDED||||||ANOVA|||Composite scores were calculated for the behavioral self-report tests tests. Differences in the pre and post test composite scores were compared using ANOVA. We tested the null hypothesis that score changes in the intervention group and control group were the same.||||0.093
72507706|NCT02078713|144547142|SUPERIORITY||Mean Difference (Final Values)|1.05||||0.63|TWO_SIDED|95.0|-3.19|5.29||P-value calculated in multiply imputed dataset|Regression, Linear|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The estimation parameter is a beta coefficient from a linear regression model, calculated in an imputed dataset. It represents additional minutes in an intervention visit versus a control visit.|||5.29|-3.19|0.63
72507707|NCT02078713|144547143|SUPERIORITY||Observed coefficient|-3.97|STANDARD_ERROR_OF_MEAN|3.34||0.24|TWO_SIDED|95.0|-10.62|2.68|||Regression, Linear||Tool group is compared to control group (ref). Bootstrapping used for standard error.|Test of follow-up score of emotional exhaustion subscale of Maslach Burnout Inventory, controlling for baseline score and site||2.68|-10.62|0.24
72507708|NCT02078713|144547143|SUPERIORITY||Observed coefficient|-1.52|STANDARD_ERROR_OF_MEAN|1.91||0.36|TWO_SIDED|95.0|-4.76|1.72|||Regression, Linear||Tool group is compared to control group (ref). Bootstrapping used for standard error|Linear regression of follow-up score for depersonalization subscale of Maslach Burnout Inventory, controlling for baseline score and site.||1.72|-4.76|0.36
72507709|NCT02078713|144547143|SUPERIORITY||Slope|-1.64|STANDARD_ERROR_OF_MEAN|1.34||0.28|TWO_SIDED|95.0|-4.61|1.34|||Regression, Linear||Tool group compared to control group (ref). Bootstrapping used for standard error.|Linear regression of follow-up score for personal accomplishment subscale of Maslach Burnout Inventory, controlling for site and baseline score.||1.34|-4.61|0.28
72507710|NCT02078713|144547144|SUPERIORITY||Odds Ratio (OR)|1.06||||0.78|TWO_SIDED|95.0|0.69|1.65||P-value calculated in multiply imputed dataset|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|||1.65|0.69|0.78
72507711|NCT02078713|144547145|SUPERIORITY||Odds Ratio (OR)|0.94||||0.75|TWO_SIDED|95.0|0.66|1.35||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison at 4 months post-enrollment||1.35|0.66|0.75
72507712|NCT02078713|144547145|SUPERIORITY||Odds Ratio (OR)|1.07||||0.71|TWO_SIDED|95.0|0.75|1.53||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison at 7 months post-enrollment||1.53|0.75|0.71
72507713|NCT02078713|144547146|SUPERIORITY||Odds Ratio (OR)|0.94||||0.75|TWO_SIDED|95.0|0.66|1.34||P-value calculated in multiply imputed dataset|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison at 4 months post-enrollment||1.34|0.66|0.75
72623190|NCT03977155|144777034|SUPERIORITY|Individual BOS-589 dose levels versus placebo were only to be tested if pooled BOS-589 doses versus placebo was significant at p\<0.05.|Mean Difference (Net)|-0.16|STANDARD_ERROR_OF_MEAN|0.228||0.4725|TWO_SIDED|95.0|-0.62|0.29|||t test|P-values were calculated from the independent two-sample t test with equal variance.||Statistical Analysis 1||0.29|-0.62|0.4725
72399146|NCT04191499|144304899|SUPERIORITY||Hazard Ratio (HR)|0.43|||<|0.0001|TWO_SIDED|95.0|0.32|0.59|||Log Rank|||Hazard ratios were estimated by Cox regression. Hazard ratios and log-rank p-values are using stratified methods by stratifying Visceral Disease, Endocrine Resistance, and Region.||0.59|0.32|<0.0001
72507714|NCT02078713|144547146|SUPERIORITY||Odds Ratio (OR)|1.17||||0.37|TWO_SIDED|95.0|0.83|1.64||P-value calculated in multiply imputed dataset|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison at 7 months post-enrollment||1.64|0.83|0.37
72507715|NCT02078713|144547147|SUPERIORITY||Odds Ratio (OR)|1.27||||0.63|TWO_SIDED|95.0|0.48|3.37||P-value calculated in multiply imputed dataset|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison at 4 months post-enrollment||3.37|0.48|0.63
72507716|NCT02078713|144547147|SUPERIORITY||Odds Ratio (OR)|1.83||||0.11|TWO_SIDED|95.0|0.88|3.8||P-value calculated in multiply imputed dataset|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison at 7 months post-enrollment||3.80|0.88|0.11
72623191|NCT03977155|144777034|SUPERIORITY||Median Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.256|||TWO_SIDED|95.0|-0.71|0.31||||||Statistical Analysis 2||0.31|-0.71|
72623192|NCT03977155|144777034|SUPERIORITY||Mean Difference (Net)|-0.13|STANDARD_ERROR_OF_MEAN|0.248|||TWO_SIDED|95.0|-0.62|0.37||||||Statistical Analysis 3||0.37|-0.62|
72623193|NCT03977155|144777034|SUPERIORITY||Mean Difference (Net)|-0.07|STANDARD_ERROR_OF_MEAN|0.262|||TWO_SIDED|95.0|-0.6|0.45||||||Statistical Analysis 4||0.45|-0.60|
72623194|NCT03977155|144777035|SUPERIORITY|Individual BOS-589 dose levels versus placebo were only to be tested if pooled BOS-589 doses versus placebo was significant at p\<0.05.|Mean Difference (Net)|0.11|STANDARD_ERROR_OF_MEAN|0.2||0.5693|TWO_SIDED|95.0|-0.28|0.51|||t test|P-values were calculated from the independent two-sample t test with equal variance.||Statistical Analysis 1||0.51|-0.28|0.5693
72623195|NCT03977155|144777035|SUPERIORITY||Mean Difference (Net)|0.14|STANDARD_ERROR_OF_MEAN|0.248|||TWO_SIDED|95.0|-0.35|0.63||||||Statistical Analysis 2||0.63|-0.35|
72623196|NCT03977155|144777035|SUPERIORITY||Mean Difference (Net)|0.09|STANDARD_ERROR_OF_MEAN|0.21|||TWO_SIDED|95.0|-0.33|0.51||||||Statistical Analysis 3||0.51|-0.33|
72507717|NCT00696657|144547156|SUPERIORITY||Estimated treatment differences|-1.19|||<|0.0001|TWO_SIDED|95.0|-1.58|-0.8|||ANOVA|Confidence interval (CIs) for treatment differences versus placebo are based on Dunnett's method.||"The comparison sequence should be read as Semaglutide 1.6 mg (with titration) - Placebo. The estimates are from an analysis of variance (ANOVA) model with treatment, country and previous treatment as fixed effects and baseline HbA1c as covariate."||-0.80|-1.58|<0.0001
72507718|NCT00696657|144547156|SUPERIORITY||Estimated treatment differences|-0.95|||<|0.0001|TWO_SIDED|95.0|-1.33|-0.57|||ANOVA|CIs for treatment differences versus placebo are based on Dunnett's method.||"The comparison sequence should be read as Semaglutide 0.8 mg (with titration) - Placebo. The estimates are from an ANOVA model with treatment, country and previous treatment as fixed effects and baseline HbA1c as covariate."||-0.57|-1.33|<0.0001
72507719|NCT00696657|144547156|SUPERIORITY||Estimated treatment differences|-0.97|||<|0.0001|TWO_SIDED|95.0|-1.35|-0.59|||ANOVA|CIs for treatment differences versus placebo are based on Dunnett's method.||"The comparison sequence should be read as Semaglutide 0.8 mg - Placebo. The estimates are from an ANOVA model with treatment, country and previous treatment as fixed effects and baseline HbA1c as covariate."||-0.59|-1.35|<0.0001
72507720|NCT00696657|144547156|SUPERIORITY||Estimated treatment differences|-0.61||||0.0002|TWO_SIDED|95.0|-0.98|-0.23|||ANOVA|CIs for treatment differences versus placebo are based on Dunnett's method.||"The comparison sequence should be read as Semaglutide 0.4 mg - Placebo. The estimates are from an ANOVA model with treatment, country and previous treatment as fixed effects and baseline HbA1c as covariate."||-0.23|-0.98|0.0002
72507721|NCT00696657|144547156|SUPERIORITY||Estimated treatment differences|-0.41||||0.0324|TWO_SIDED|95.0|-0.79|-0.02|||ANOVA|CIs for treatment differences versus placebo are based on Dunnett's method.||"The comparison sequence should be read as Semaglutide 0.2 mg - Placebo. The estimates are from an ANOVA model with treatment, country and previous treatment as fixed effects and baseline HbA1c as covariate."||-0.02|-0.79|0.0324
72507722|NCT00696657|144547156|SUPERIORITY||Estimated treatment differences|-0.09||||0.9772|TWO_SIDED|95.0|-0.46|0.28|||ANOVA|CIs for treatment differences versus placebo are based on Dunnett's method.||"The comparison sequence should be read as Semaglutide 0.1 mg - Placebo. The estimates are from an ANOVA model with treatment, country and previous treatment as fixed effects and baseline HbA1c as covariate."||0.28|-0.46|0.9772
72507723|NCT00696657|144547156|OTHER||Estimated treatment differences|-0.35|||||TWO_SIDED|95.0|-0.64|-0.06|||ANOVA|CIs for treatment differences versus liraglutide are not corrected for multiple testing.||"The comparison sequence should be read as Semaglutide 1.6 mg (with titration) - Liraglutide 1.8 mg. The estimates are from an ANOVA model with treatment, country and previous treatment as fixed effects and baseline HbA1c as covariate."||-0.06|-0.64|
72507724|NCT00696657|144547156|OTHER||Estimated treatment differences|-0.11|||||TWO_SIDED|95.0|-0.39|0.18|||ANOVA|CIs for treatment differences versus liraglutide are not corrected for multiple testing.||"The comparison sequence should be read as Semaglutide 0.8 mg (with titration) - Liraglutide 1.8 mg. The estimates are from an ANOVA model with treatment, country and previous treatment as fixed effects and baseline HbA1c as covariate."||0.18|-0.39|
72507725|NCT00696657|144547156|OTHER||Estimated treatment differences|-0.13|||||TWO_SIDED|95.0|-0.42|0.16|||ANOVA|CIs for treatment differences versus liraglutide are not corrected for multiple testing.||"The comparison sequence should be read as Semaglutide 0.8 mg - Liraglutide 1.8 mg. The estimates are from an ANOVA model with treatment, country and previous treatment as fixed effects and baseline HbA1c as covariate."||0.16|-0.42|
72566250|NCT00680186|144663143|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.66||||0.3021|TWO_SIDED|95.0|0.29|1.46|||Regression, Cox|||HR vs. Warfarin (events occurring between randomisation and end of ptp). The time to first occurrence of the endpoint was compared between treatment groups using the Cox PH model, including the factors treatment, active cancer at baseline, symptomatic PE at baseline, and the interaction between active cancer and symptomatic PE.||1.46|0.29|0.3021
72507726|NCT00696657|144547156|OTHER||Estimated treatment differences|0.24|||||TWO_SIDED|95.0|-0.05|0.52|||ANOVA|CIs for treatment differences versus liraglutide are not corrected for multiple testing.||"The comparison sequence should be read as Semaglutide 0.4 mg - Liraglutide 1.8 mg. The estimates are from an ANOVA model with treatment, country and previous treatment as fixed effects and baseline HbA1c as covariate."||0.52|-0.05|
72507727|NCT00696657|144547156|OTHER||Estimated treatment differences|0.44|||||TWO_SIDED|95.0|0.15|0.73|||ANOVA|CIs for treatment differences versus liraglutide are not corrected for multiple testing.||"The comparison sequence should be read as Semaglutide 0.2 mg - Liraglutide 1.8 mg. The estimates are from an ANOVA model with treatment, country and previous treatment as fixed effects and baseline HbA1c as covariate."||0.73|0.15|
72507728|NCT00696657|144547156|OTHER||Estimated treatment differences|0.75|||||TWO_SIDED|95.0|0.48|1.03|||ANOVA|CIs for treatment differences versus liraglutide are not corrected for multiple testing.||"The comparison sequence should be read as Semaglutide 0.1 mg - Liraglutide 1.8 mg. The estimates are from an ANOVA model with treatment, country and previous treatment as fixed effects and baseline HbA1c as covariate."||1.03|0.48|
72566251|NCT00680186|144663144|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.69||||||95.0|0.36|1.32|||Regression, Cox||This is the analysis of the time to the first MBE.|HR vs. Warfarin (events occurring between 1st intake of study drug and last intake of study drug + 6 days). The time to first occurrence of MBE was compared between treatment groups using the Cox PH model, including the factors treatment, active cancer at baseline, symptomatic PE at baseline, and the interaction between active cancer and symptomatic PE.||1.32|0.36|
72507729|NCT00696657|144547156|OTHER||Estimated treatment differences|-0.84|||||TWO_SIDED|95.0|-1.12|-0.56|||ANOVA|CIs for treatment differences versus liraglutide are not corrected for multiple testing.||"The comparison sequence should be read as Liraglutide 1.8 mg - Placebo . The estimates are from an ANOVA model with treatment, country and previous treatment as fixed effects and baseline HbA1c as covariate."||-0.56|-1.12|
72507730|NCT00696657|144547156|OTHER||Estimated treatment differences|-0.51|||||TWO_SIDED|95.0|-0.8|-0.22|||ANOVA|CIs for treatment differences versus liraglutide are not corrected for multiple testing.||"The comparison sequence should be read as Semaglutide 1.6 mg (with titration) - Liraglutide 1.2 mg. The estimates are from an ANOVA model with treatment, country and previous treatment as fixed effects and baseline HbA1c as covariate."||-0.22|-0.80|
72507731|NCT00696657|144547156|OTHER||Estimated treatment differences|-0.27|||||TWO_SIDED|95.0|-0.56|0.02|||ANOVA|CIs for treatment differences versus liraglutide are not corrected for multiple testing.||"The comparison sequence should be read as Semaglutide 0.8 mg (with titration) - Liraglutide 1.2 mg. The estimates are from an ANOVA model with treatment, country and previous treatment as fixed effects and baseline HbA1c as covariate."||0.02|-0.56|
72566252|NCT00680186|144663144|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.67|||<|0.0001|TWO_SIDED|95.0|0.56|0.81|||Regression, Cox||This is the analysis of the time to the first occurrence of any bleeding event.|HR vs. Warfarin (events occurring between 1st intake of study drug and last intake of study drug + 6 days). The time to first occurrence of any bleeding was compared between treatment groups using the Cox PH model, including the factors treatment, active cancer at baseline, symptomatic PE at baseline, and the interaction between active cancer and symptomatic PE.||0.81|0.56|<0.0001
72566253|NCT00645944|144663147|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.8||||0.039|TWO_SIDED|95.0|-7.5|-0.2|||Mixed Models Analysis|||||-0.2|-7.5|0.039
72475804|NCT01655693|144477269|SUPERIORITY||Hazard Ratio (HR)|1.0|||>|0.991|TWO_SIDED|95.0||||Treatment comparison of DT pooled with BCS used non-stratified Log-rank test at significance level p=0.05.|Log Rank|Log rank test is used after checking the proportional hazards (PH) assumption is valid. The Wilcoxon test is used when the PH assumption fails.|The hazard ratio was controlled for the overall type I error rate at 5% (2-sided) corresponding to 95% confidence interval (CI) and type II error rate as 15%.|Initial 24 month assessment: the primary aim was to demonstrate the superiority of DT pooled (20 mg/m2 and 30 mg/m2) compared to BSC treatment and not individual DT groups per protocol. OS was estimated using the Kaplan-Meier method. The comparison of treatment groups (pooled DT groups versus BSC group) was performed using a non-stratified log-rank test as the primary analysis. The Cox model and Wilcoxon test was used for sensitivity analysis.||||>0.991
72475805|NCT01655693|144477269|SUPERIORITY||Hazard Ratio (HR)|1.0||||0.796|TWO_SIDED|95.0||||Treatment comparison of DT pooled with BCS used non-stratified Log-rank test at significance level p=0.05.|Log Rank|Log rank test is used after checking the proportional hazards (PH) assumption is valid. The Wilcoxon test is used when the PH assumption fails.|The hazard ratio was controlled for the overall type I error rate at 5% (2-sided) corresponding to 95% confidence interval (CI) and type II error rate as 15%.|Follow-up 45 month assessment: the primary aim was to demonstrate the superiority of DT pooled (20 mg/m2 and 30 mg/m2) compared to BSC treatment and not individual DT groups per protocol. OS was estimated using the Kaplan-Meier method. The comparison of treatment groups (pooled DT groups versus BSC group) was performed using a non-stratified log-rank test as the primary analysis. The Cox model and Wilcoxon test was used for sensitivity analysis.||||0.796
72475806|NCT01655693|144477270|SUPERIORITY||Hazard Ratio (HR)|1.0||||0.7|TWO_SIDED|95.0||||Treatment comparison with BCS using non-stratified Log-rank test at significance level p=0.05.|Log Rank||Hazard ratio for treatment variable was determined by Cox model. The hazard ratio was controlled for the overall type I error rate at 5% (2-sided) and type II error rate as 15%.|PFS was estimated using Kaplan-Meier methods and plotted as curves by treatment group. For comparison between treatment groups (pooled DT 20 mg/m2 and 30 mg/m2 versus BSC) used Log-rank test as primary analysis. Hazard ratio, mean, and mean PFS rate were given with corresponding 95% CI.||||0.7
72475807|NCT01655693|144477271|SUPERIORITY|||||||1||||||Treatment comparison with BCS using Fisher's exact test at significance level p=0.05.|Fisher Exact|||The comparisons between groups (pooled DT 20 mg/m2 and 30mg/m2 versus BSC) used Fisher's exact test.||||1.0
72507732|NCT00696657|144547156|OTHER||Estimated treatment differences|-0.29|||||TWO_SIDED|95.0|-0.58|0.01|||ANOVA|CIs for treatment differences versus liraglutide are not corrected for multiple testing.||"The comparison sequence should be read as Semaglutide 0.8 mg - Liraglutide 1.2 mg. The estimates are from an ANOVA model with treatment, country and previous treatment as fixed effects and baseline HbA1c as covariate."||0.01|-0.58|
72507733|NCT00696657|144547156|OTHER||Estimated treatment differences|0.08|||||TWO_SIDED|95.0|-0.22|0.37|||ANOVA|CIs for treatment differences versus liraglutide are not corrected for multiple testing.||"The comparison sequence should be read as Semaglutide 0.4 mg - Liraglutide 1.2 mg. The estimates are from an ANOVA model with treatment, country and previous treatment as fixed effects and baseline HbA1c as covariate."||0.37|-0.22|
72566254|NCT01523587|144663148|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.814||||0.0103|TWO_SIDED|95.0|0.693|0.956||P-value from log-rank stratified by Race (two-sided). Hazard ratio (Afatinib vs Erlotinib) from Cox proportional hazards model stratified by Race.|Log Rank|||A Cox proportional hazards model without the randomization stratification variable was used for each subgroup category, along with the corresponding log-rank test.||0.956|0.693|0.0103
72566255|NCT01523587|144663149|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.841||||0.0193|TWO_SIDED|95.0|0.727|0.973||P-value from log-rank stratified by Race (two-sided). Hazard ratio (Afatinib vs Erlotinib) from Cox proportional hazards model stratified by Race.|Log Rank|||A Cox proportional-hazards model, stratified by race, was used to estimate the hazard ratio and 95% confidence interval (CI) between the two treatment groups.||0.973|0.727|0.0193
72566256|NCT01523587|144663150|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.06||||0.0551|TWO_SIDED|95.0|0.98|4.32||Odds ratio (Afatinib vs Erlotinib), 95% CI and p-value (two-sided) from logistic regression stratified by race.|Regression, Logistic|||||4.32|0.98|0.0551
72475808|NCT03001076|144477340|SUPERIORITY||Difference in LS mean|-28.45|STANDARD_ERROR_OF_MEAN|3.022|<|0.001|TWO_SIDED|95.0|-34.376|-22.531|||ANCOVA|||||-22.531|-34.376|<0.001
72475809|NCT03001076|144477341|SUPERIORITY||Difference in LS mean|-23.56|STANDARD_ERROR_OF_MEAN|2.777|<|0.001|TWO_SIDED|95.0|-29.005|-18.121|||ANCOVA|||||-18.121|-29.005|<0.001
72475810|NCT03001076|144477342|SUPERIORITY||Difference in LS mean|-17.99|STANDARD_ERROR_OF_MEAN|2.018|<|0.001|TWO_SIDED|95.0|-21.94|-14.03|||ANCOVA|||||-14.030|-21.940|<0.001
72475811|NCT03001076|144477343|SUPERIORITY||Difference in LS mean|-19.32|STANDARD_ERROR_OF_MEAN|2.341|<|0.001|TWO_SIDED|95.0|-23.908|-14.732|||ANCOVA|||||-14.732|-23.908|<0.001
72475812|NCT03001076|144477344|SUPERIORITY||Location shift|-31.045|||<|0.001|TWO_SIDED|95.0|-44.761|-17.401|||Wilcoxon Rank Sum Test||The location shift and asymptotic 95% confidence interval are based on Hodges-Lehman estimation.|||-17.401|-44.761|<0.001
72475813|NCT03001076|144477345|SUPERIORITY||Difference in LS mean|-4.53|STANDARD_ERROR_OF_MEAN|5.24|=|0.388|TWO_SIDED|95.0|-14.877|5.812|||ANCOVA|||||5.812|-14.877|=0.388
72566257|NCT01523587|144663151|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.56||||0.002|TWO_SIDED|95.0|1.18|2.06|||Regression, Logistic|Odds ratio (Afatinib vs Erlotinib), 95% CI and p-value (two-sided) from logistic regression stratified by race.||||2.06|1.18|0.0020
72475814|NCT03001076|144477346|SUPERIORITY||Difference in LS mean|-5.89|STANDARD_ERROR_OF_MEAN|1.845|=|0.002|TWO_SIDED|95.0|-9.528|-2.25|||ANCOVA|||||-2.250|-9.528|=0.002
72475815|NCT03001076|144477348|SUPERIORITY||Difference in LS mean|-31.09|STANDARD_ERROR_OF_MEAN|2.238|<|0.001|TWO_SIDED|95.0|-35.498|-26.682|||ANCOVA|||Change from Baseline to Week 4||-26.682|-35.498|<0.001
72475816|NCT03001076|144477348|SUPERIORITY||Difference in LS mean|-29.12|STANDARD_ERROR_OF_MEAN|2.513|<|0.001|TWO_SIDED|95.0|-34.074|-24.168|||ANCOVA|||Change from Baseline to Week 8||-24.168|-34.074|<0.001
72475817|NCT03001076|144477349|SUPERIORITY||Difference in LS mean|-25.26|STANDARD_ERROR_OF_MEAN|2.004|<|0.001|TWO_SIDED|95.0|-29.204|-21.308|||ANCOVA|||Change from Baseline to Week 4||-21.308|-29.204|<0.001
72475818|NCT03001076|144477349|SUPERIORITY||Difference in LS mean|-23.75|STANDARD_ERROR_OF_MEAN|2.268|<|0.001|TWO_SIDED|95.0|-28.219|-19.276|||ANCOVA|||Change from Baseline to Week 8||-19.276|-28.219|<0.001
72507734|NCT00696657|144547156|OTHER||Estimated treatment differences|0.28|||||TWO_SIDED|95.0|-0.02|0.57|||ANOVA|CIs for treatment differences versus liraglutide are not corrected for multiple testing.||"The comparison sequence should be read as Semaglutide 0.2 mg - Liraglutide 1.2 mg. The estimates are from an ANOVA model with treatment, country and previous treatment as fixed effects and baseline HbA1c as covariate."||0.57|-0.02|
72507735|NCT00696657|144547156|OTHER||Estimated treatment differences|0.59|||||TWO_SIDED|95.0|0.31|0.88|||ANOVA|CIs for treatment differences versus liraglutide are not corrected for multiple testing.||"The comparison sequence should be read as Semaglutide 0.1 mg - Liraglutide 1.2 mg. The estimates are from an ANOVA model with treatment, country and previous treatment as fixed effects and baseline HbA1c as covariate."||0.88|0.31|
72507736|NCT00696657|144547156|OTHER||Estimated treatment differences|-0.68|||||TWO_SIDED|95.0|-0.97|-0.4|||ANOVA|CIs for treatment differences versus liraglutide are not corrected for multiple testing.||"The comparison sequence should be read as Liraglutide 1.2 mg - Placebo. The estimates are from an ANOVA model with treatment, country and previous treatment as fixed effects and baseline HbA1c as covariate."||-0.40|-0.97|
72507737|NCT04688346|144547234|NON_INFERIORITY|t-test|Mean Difference (Final Values)|1.0||||0.05|TWO_SIDED||||||t-test, 2 sided|||||||0.05
72475819|NCT03001076|144477350|SUPERIORITY||Difference in LS mean|-20.41|STANDARD_ERROR_OF_MEAN|1.513|<|0.001|TWO_SIDED|95.0|-23.39|-17.43|||ANCOVA|||Change from Baseline to Week 4||-17.430|-23.390|<0.001
72475820|NCT03001076|144477350|SUPERIORITY||Difference in LS mean|-18.46|STANDARD_ERROR_OF_MEAN|1.651|<|0.001|TWO_SIDED|95.0|-21.71|-15.206|||ANCOVA|||Change from Baseline to Week 8||-15.206|-21.710|<0.001
72475821|NCT03001076|144477351|SUPERIORITY||Difference in LS mean|-0.8|STANDARD_ERROR_OF_MEAN|4.99|=|0.873|TWO_SIDED|95.0|-10.663|9.059|||ANCOVA|||Change from Baseline to Week 4||9.059|-10.663|=0.873
72475822|NCT03001076|144477351|SUPERIORITY||Difference in LS mean|-0.08|STANDARD_ERROR_OF_MEAN|5.131|=|0.988|TWO_SIDED|95.0|-10.215|10.055|||ANCOVA|||Change from Baseline to Week 8||10.055|-10.215|=0.988
72475823|NCT03001076|144477352|SUPERIORITY||Difference in LS mean|-8.59|STANDARD_ERROR_OF_MEAN|1.619|<|0.001|TWO_SIDED|95.0|-11.778|-5.394|||ANCOVA|||Change from Baseline to Week 4||-5.394|-11.778|<0.001
72475824|NCT03001076|144477352|SUPERIORITY||Difference in LS mean|-6.42|STANDARD_ERROR_OF_MEAN|1.712|<|0.001|TWO_SIDED|95.0|-9.798|-3.049|||ANCOVA|||Change from Baseline to Week 8||-3.049|-9.798|<0.001
72475825|NCT00293059|144477415|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||inverting 2 one-sided tests|||||||< 0.0001
72475826|NCT00878826|144477502|SUPERIORITY_OR_OTHER|||||||0.4|||||||Kruskal-Wallis|||at 14-18 weeks gestational age||||0.4
72507738|NCT04494633|144547238|SUPERIORITY|||||||0.482314|||||||t-test, 2 sided|The change for each group was analyzed using a 2-tailed, unpaired, independent means, t-test with 61 degrees of freedom.||||||0.482314
72475827|NCT00878826|144477502|SUPERIORITY_OR_OTHER|||||||0.9|||||||Kruskal-Wallis|||at 24-28 weeks gestational age||||0.9
72475828|NCT00878826|144477502|SUPERIORITY_OR_OTHER|||||||0.3|||||||Kruskal-Wallis|||at 32-34 weeks gestational age||||0.3
72475829|NCT01468181|144477508|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.77|||<|0.001|TWO_SIDED|95.0|-1.87|-1.67|||t-test, 2 sided|p-values are from within-group change t-test at the level of 0.05||HbA1c at 26 Weeks||-1.67|-1.87|<0.001
72475830|NCT01468181|144477508|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.65|||<|0.001|TWO_SIDED|95.0|-1.75|-1.55|||t-test, 2 sided|p-values are from within-group change t-test at the level of 0.05||HbA1c at 52 Weeks||-1.55|-1.75|<0.001
72475831|NCT01468181|144477510|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-43.9|||<|0.001|TWO_SIDED|95.0|-47.8|-40.0|||t-test, 2 sided|p-values are from within-group change t-test at the level of 0.05||FBG at 26 Weeks||-40.0|-47.8|<0.001
72507739|NCT04494633|144547239|SUPERIORITY|||||||0.876964|||||||t-test, 2 sided|The change for each group was analyzed using a 2-tailed, unpaired, independent means, t test with 61 degrees of freedom.||||||.876964
72475832|NCT01468181|144477510|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-42.6|||<|0.001|TWO_SIDED|95.0|-46.4|-38.7|||t-test, 2 sided|p-values are from within-group change t-test at the level of 0.05||FBG at 52 Weeks||-38.7|-46.4|<0.001
72475833|NCT01468181|144477511|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-42.42|||<|0.001|TWO_SIDED|95.0|-46.55|-38.29|||t-test, 2 sided|p-values are from within-group change t-test at the level of 0.05||Pre-morning meal at 26 Weeks||-38.29|-46.55|<0.001
72475834|NCT01468181|144477511|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-42.6|||<|0.001|TWO_SIDED|95.0|-46.44|-38.76|||t-test, 2 sided|p-values are from within-group change t-test at the level of 0.05||Pre-morning meal at 52 Weeks||-38.76|-46.44|<0.001
72475835|NCT01468181|144477511|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-68.48|||<|0.001|TWO_SIDED|95.0|-74.18|-62.79|||t-test, 2 sided|p-values are from within-group change t-test at the level of 0.05||2 hours post-morning meal at 26 Weeks||-62.79|-74.18|<0.001
72475836|NCT01468181|144477511|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-66.08|||<|0.001|TWO_SIDED|95.0|-72.12|-60.04|||t-test, 2 sided|p-values are from within-group change t-test at the level of 0.05||2 hours post-morning meal at 52 Weeks||-60.04|-72.12|<0.001
72475837|NCT01468181|144477511|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-48.21|||<|0.001|TWO_SIDED|95.0|-53.32|-43.09|||t-test, 2 sided|p-values are from within-group change t-test at the level of 0.05||Pre-midday meal at 26 Weeks||-43.09|-53.32|<0.001
72507740|NCT04494633|144547240|SUPERIORITY|||||||0.66602|||||||t-test, 2 sided|The change for each group was analyzed using a 2-tailed, unpaired, independent means, with 61 degrees of freedom.||||||.66602
72507741|NCT04494633|144547241|SUPERIORITY|||||||0.726421|||||||t-test, 2 sided|Two-tailed unpaired t test comparing change for control (Pre to 2 weeks later) to case (Pre- to 2 weeks post) with 61 degrees of freedom.||||||.726421
72507742|NCT04494633|144547242|SUPERIORITY|||||||0.908468|||||||t-test, 2 sided|The statistical test used was a 2 tailed, unpaired t test with 61 degrees of freedom.||||||0.908468
72507743|NCT04494633|144547243|SUPERIORITY|||||||0.468104|||||||t-test, 2 sided|The groups were compared using a two tailed unpaired t test with 61 degrees of freedom.||||||.468104
72507744|NCT02948777|144547244|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
72507745|NCT02948777|144547245|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
72507746|NCT02948777|144547246|OTHER|||||||0.31|||||||Wilcoxon (Mann-Whitney)|||||||0.31
72507747|NCT02948777|144547247|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
72507748|NCT02948777|144547248|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
72475838|NCT01468181|144477511|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-47.51|||<|0.001|TWO_SIDED|95.0|-52.77|-42.24|||t-test, 2 sided|p-values are from within-group change t-test at the level of 0.05||Pre-midday meal at 52 Weeks||-42.24|-52.77|<0.001
72475839|NCT01468181|144477511|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-67.06|||<|0.001|TWO_SIDED|95.0|-73.02|-61.11|||t-test, 2 sided|p-values are from within-group change t-test at the level of 0.05||2 hours post-midday meal at 26 Weeks||-61.11|-73.02|<0.001
72475840|NCT01468181|144477511|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-63.17|||<|0.001|TWO_SIDED|95.0|-69.16|-57.18|||t-test, 2 sided|p-values are from within-group change t-test at the level of 0.05||2 hours post-midday meal at 52 Weeks||-57.18|-69.16|<0.001
72475841|NCT01468181|144477511|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-44.0|||<|0.001|TWO_SIDED|95.0|-49.67|-38.34|||t-test, 2 sided|p-values are from within-group change t-test at the level of 0.05||Pre-evening meal at 26 Weeks||-38.34|-49.67|<0.001
72475842|NCT01468181|144477511|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-43.88|||<|0.001|TWO_SIDED|95.0|-49.55|-38.21|||t-test, 2 sided|p-values are from within-group change t-test at the level of 0.05||Pre-evening meal at 52 Weeks||-38.21|-49.55|<0.001
72475843|NCT01468181|144477511|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-62.91|||<|0.001|TWO_SIDED|95.0|-69.32|-56.5|||t-test, 2 sided|p-values are from within-group change t-test at the level of 0.05||2 hours post-evening meal at 26 Weeks||-56.50|-69.32|<0.001
72475844|NCT01468181|144477511|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-60.84|||<|0.001|TWO_SIDED|95.0|-66.95|-54.74|||t-test, 2 sided|p-values are from within-group change t-test at the level of 0.05||2 hours post-evening meal at 52 Weeks||-54.74|-66.95|<0.001
72507749|NCT02948777|144547249|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
72507750|NCT02948777|144547250|OTHER|||||||0.27|||||||Wilcoxon (Mann-Whitney)|||||||0.27
72507751|NCT02948777|144547251|OTHER|||||||0.22|||||||Wilcoxon (Mann-Whitney)|||||||0.22
72475845|NCT01468181|144477511|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-61.15|||<|0.001|TWO_SIDED|95.0|-66.93|-55.37|||t-test, 2 sided|p-values are from within-group change t-test at the level of 0.05||Bedtime meal at 26 Weeks||-55.37|-66.93|<0.001
72475846|NCT01468181|144477511|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-60.16|||<|0.001|TWO_SIDED|95.0|-66.07|-54.25|||t-test, 2 sided|p-values are from within-group change t-test at the level of 0.05||Bedtime meal at 52 Weeks||-54.25|-66.07|<0.001
72507752|NCT02948777|144547252|OTHER|||||||0.31|||||||Kruskal-Wallis|||||||0.31
72507753|NCT02948777|144547253|OTHER|||||||0.61|||||||Wilcoxon (Mann-Whitney)|||||||0.61
72507754|NCT02948777|144547254|OTHER|||||||0.11|||||||Wilcoxon (Mann-Whitney)|||||||0.11
72507755|NCT02948777|144547255|OTHER|||||||0.003|||||||Wilcoxon (Mann-Whitney)|||||||0.003
72507756|NCT02948777|144547256|OTHER|||||||0.027|||||||Wilcoxon (Mann-Whitney)|||||||0.027
72507757|NCT02948777|144547257|OTHER|||||||0.84|||||||Wilcoxon (Mann-Whitney)|||||||0.84
72507758|NCT02948777|144547258|OTHER|||||||0.59|||||||Wilcoxon (Mann-Whitney)|||||||0.59
72507759|NCT02948777|144547259|OTHER|||||||0.81|||||||Wilcoxon (Mann-Whitney)|||||||0.81
72507760|NCT02948777|144547260|OTHER|||||||0.91|||||||Wilcoxon (Mann-Whitney)|||||||0.91
72507761|NCT02948777|144547261|OTHER|||||||1|||||||Wilcoxon (Mann-Whitney)|||||||1
72507762|NCT02948777|144547262|OTHER|||||||0.68|||||||Wilcoxon (Mann-Whitney)|||||||0.68
72507763|NCT02948777|144547263|OTHER|||||||0.013|||||||Wilcoxon (Mann-Whitney)|||||||0.013
72507764|NCT02948777|144547264|OTHER|||||||0.91|||||||Wilcoxon (Mann-Whitney)|||||||0.91
72507765|NCT02948777|144547265|OTHER|||||||0.27|||||||Wilcoxon (Mann-Whitney)|||||||0.27
72507766|NCT02948777|144547267|OTHER|||||||0.84|||||||Wilcoxon (Mann-Whitney)|||||||0.84
72507767|NCT02948777|144547268|OTHER|||||||0.89|||||||Wilcoxon (Mann-Whitney)|||||||0.89
72623197|NCT03977155|144777035|SUPERIORITY||Mean Difference (Net)|0.05|STANDARD_ERROR_OF_MEAN|0.231|||TWO_SIDED|95.0|-0.41|0.51||||||Statistical Analysis 4||0.51|-0.41|
72507768|NCT02311478|144547269|OTHER|Given that this is a observational cohort design we do not use either non-inferiority or equivalence analysis. Using ANOVA we test for differences in the number of days per month of bleeding between the 90 days pre-insertion, the 90 days following insertion, and 91-180 days following insertion.|Mean Difference (Net)|1.77|STANDARD_ERROR_OF_MEAN|0.28|<|0.05|TWO_SIDED|95.0|1.2|2.3||The p-value is not adjusted for multiple comparisons.|ANOVA|df=2||The null hypothesis is that there is no difference between the number of days of bleeding per month at baseline and the days of bleeding per month during 90 days after insertion, and months or 91-180 days following insertion.||2.3|1.2|<0.05
72507769|NCT02311478|144547269|EQUIVALENCE|α of 0.05 or lower.|Mean Difference (Final Values)|0.93|||<|0.05|TWO_SIDED|95.0|0.36|1.5|||t-test, 2 sided|||The estimation parameter compares the 90 days following to the 90 days prior.||1.5|0.36|<0.05
72507770|NCT03242928|144547272|SUPERIORITY||Mean Difference (Final Values)|-0.087|STANDARD_ERROR_OF_MEAN|0.037|=|0.021|TWO_SIDED|95.0|-0.161|-0.013|||ANCOVA|||||-0.013|-0.161|= 0.021
72507771|NCT03242928|144547273|SUPERIORITY||Mean Difference (Final Values)|-0.177|STANDARD_ERROR_OF_MEAN|0.077|=|0.025|TWO_SIDED|95.0|-0.331|-0.023|||ANOVA|||||-0.023|-0.331|= 0.025
72507772|NCT03242928|144547274|SUPERIORITY||Mean Difference (Final Values)|-0.07|STANDARD_ERROR_OF_MEAN|0.038|=|0.072|TWO_SIDED|95.0|-0.146|0.006|||ANCOVA|||||0.006|-0.146|= 0.072
72507773|NCT00390780|144547276|NON_INFERIORITY_OR_EQUIVALENCE|"Non inferiority assumptions:~Type of test: one-sided Inferiority margin: -15% Expected cure rate: 70% Type I error: 2.5% Type II error: 5%"|comparison of proportion clinical cure|0.15|||>|0.025|ONE_SIDED|95.0|-0.15|||Significance level was \<0.025|one-sided test|||"Analyses for ITT and PP populations:~H0: clinical cure rate for miconazole Lauriad minus clinical cure rate for clotrimazole troches is less than or equal to -0.15 H1: clinical cure rate for miconazole Lauriad minus clinical cure rate for Mycelex troches is greater than -0.15"|||-0.15|>0.025
72507774|NCT00390780|144547277|NON_INFERIORITY_OR_EQUIVALENCE|"Non inferiority assumptions:~Type of test: one-sided Inferiority margin: -15% Expected cure rate: 70% Type I error: 2.5% Type II error: 5%"|comparison of proportion clinical cure|0.15|||>|0.025|ONE_SIDED|95.0|-0.15|||Significance level was \<0.025.|one-sided noninferiority test|||"Analysis for ITT and PP populations:~H0: clinical cure rate for miconazole Lauriad minus clinical cure rate for clotrimazole troches is less than or equal to -0.15 H1: clinical cure rate for miconazole Lauriad minus clinical cure rate for Mycelex troches is greater than -0.15"|||-0.15|>0.025
72507775|NCT00390780|144547278|NON_INFERIORITY_OR_EQUIVALENCE|"Non inferiority assumptions:~Type of test: one-sided Inferiority margin: -15% Type I error: 2.5% Type II error: 5%"|compare proportion of clinical success|0.15||||0.0974|ONE_SIDED|95.0|-0.15|||Significance level was \<0.025.|Cochran-Mantel-Haenszel|||"Analysis for ITT population:~H0: clinical success rate for miconazole Lauriad minus clinical success rate for clotrimazole troches is less than or equal to -0.15 H1: clinical success rate for miconazole Lauriad minus clinical success rate for Mycelex troches is greater than -0.15"|||-0.15|0.0974
72507776|NCT00390780|144547278|NON_INFERIORITY_OR_EQUIVALENCE|"Non inferiority assumptions:~Type of test: one-sided Inferiority margin: -15% Type I error: 2.5% Type II error: 5%"|Compare proportion of clinical success|0.15||||0.1115|ONE_SIDED|95.0|-0.15|||Significance level was \<0.025.|Cochran-Mantel-Haenszel|||"Analysis for PP population:~H0: clinical success rate for miconazole Lauriad minus clinical success rate for clotrimazole troches is less than or equal to -0.15 H1: clinical success rate for miconazole Lauriad minus clinical success rate for Mycelex troches is greater than -0.15"|||-0.15|0.1115
72507777|NCT00390780|144547279|NON_INFERIORITY_OR_EQUIVALENCE|"Non inferiority assumptions:~Type of test: one-sided Inferiority margin: -15% Type I error: 2.5% Type II error: 5%"|compare proportion of clinical success|0.15||||0.8787|ONE_SIDED|95.0|-0.15|||Significance level was \<0.025.|Cochran-Mantel-Haenszel|||"Analysis for ITT population:~H0: clinical success rate for miconazole Lauriad minus clinical success rate for clotrimazole troches is less than or equal to -0.15 H1: clinical success rate for miconazole Lauriad minus clinical success rate for Mycelex troches is greater than -0.15"|||-0.15|0.8787
72566258|NCT01523587|144663152|SUPERIORITY_OR_OTHER||Adjusted mean|-1.2|STANDARD_ERROR_OF_MEAN|1.77||0.5|TWO_SIDED|95.0|-4.67|2.28|||ANCOVA||Mean was adjusted for baseline sum of diameters and race.|The analysis will compare the treatments using analysis of covariance (ANCOVA) for minimum sum of diameters, using baseline sum of diameters as a covariate. The randomization strata will be included as classification factors.||2.28|-4.67|0.500
72566259|NCT01523587|144663154|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.89||||0.2562|TWO_SIDED|95.0|0.72|1.09||p-value calculated using log rank test stratified by race.|Regression, Cox||Hazard ratio (Afatinib vs Erlotinib) from Cox proportional hazard model stratified by race.|The results shown relate to Time to Deterioration in Coughing.||1.09|0.72|0.2562
72566260|NCT01523587|144663154|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.79||||0.0078|TWO_SIDED|95.0|0.66|0.94||p-value calculated using log rank test stratified by race.|Regression, Cox||Hazard ratio (Afatinib vs Erlotinib) from Cox proportional hazard model stratified by race.|The results shown relate to Time to Deterioration in Dyspnoea||0.94|0.66|0.0078
72623198|NCT03977155|144777036|SUPERIORITY|Individual BOS-589 dose levels versus placebo were only to be tested if pooled BOS-589 doses versus placebo was significant at p\<0.05.|Mean Difference (Net)|-7.71|STANDARD_ERROR_OF_MEAN|25.208||0.7603|TWO_SIDED|95.0|-57.76|42.33|||t test|P-values were calculated from the independent two-sample t test with equal variance.||Statistical Analysis 1||42.33|-57.76|0.7603
72475847|NCT01468181|144477512|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.14|||<|0.277|TWO_SIDED|95.0|-0.4|0.12|||t-test, 2 sided|p-values are from within-group change t-test at the level of 0.05||Body weight at 26 Weeks||0.12|-0.40|<0.277
72475848|NCT01468181|144477512|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.13||||0.382|TWO_SIDED|95.0|-0.42|0.16|||t-test, 2 sided|p-values are from within-group change t-test at the level of 0.05||Body weight at 52 Weeks||0.16|-0.42|0.382
72475849|NCT01468181|144477513|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|28.59|||<|0.001|TWO_SIDED|95.0|26.0|31.18|||t-test, 2 sided|p-values are from within-group change t-test at the level of 0.05||HOMA2-B% at 26 Weeks||31.18|26.00|<0.001
72507778|NCT00390780|144547279|NON_INFERIORITY_OR_EQUIVALENCE|"Non inferiority assumptions:~Type of test: one-sided Inferiority margin: -15% Type I error: 2.5% Type II error: 5%"|compare proportion of clinical success|0.15||||0.7969|ONE_SIDED|95.0|-0.15|||Significance level was \<0.025.|Cochran-Mantel-Haenszel|||"Analysis for PP population:~H0: clinical success rate for miconazole Lauriad minus clinical success rate for clotrimazole troches is less than or equal to -0.15 H1: clinical success rate for miconazole Lauriad minus clinical success rate for Mycelex troches is greater than -0.15"|||-0.15|0.7969
72475850|NCT01468181|144477513|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|27.57|||<|0.001|TWO_SIDED|95.0|24.73|30.41|||t-test, 2 sided|p-values are from within-group change t-test at the level of 0.05||HOMA2-B% at 52 Weeks||30.41|24.73|<0.001
72475851|NCT01468181|144477513|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.57||||0.194|TWO_SIDED|95.0|-6.46|1.32|||t-test, 2 sided|p-values are from within-group change t-test at the level of 0.05||HOMA2-S% at 26 Weeks||1.32|-6.46|0.194
72507779|NCT00390780|144547280|NON_INFERIORITY_OR_EQUIVALENCE|"Non inferiority assumptions:~Type of test: one-sided Inferiority margin: -15% Type I error: 2.5% Type II error: 5%"|compare proportion of partial response|0.15||||0.882|ONE_SIDED|95.0|-0.15|||Significance level was \<0.025.|Cochran-Mantel-Haenszel|||"Analysis for ITT population:~H0: partial response rate for miconazole Lauriad minus partial response rate for clotrimazole troches is less than or equal to -0.15 H1: partial response rate for miconazole Lauriad minus partial response rate for Mycelex troches is greater than -0.15"|||-0.15|0.8820
72507780|NCT00390780|144547280|NON_INFERIORITY_OR_EQUIVALENCE|"Non inferiority assumptions:~Type of test: one-sided Inferiority margin: -15% Type I error: 2.5% Type II error: 5%"|compare proportion of partial response|0.15||||0.9033|ONE_SIDED|95.0|-0.15|||Significance level was \<0.025.|Cochran-Mantel-Haenszel|||"Analysis for PP population:~H0: partial response rate for miconazole Lauriad minus partial response rate for clotrimazole troches is less than or equal to -0.15 H1: partial response rate for miconazole Lauriad minus partial response rate for Mycelex troches is greater than -0.15"|||-0.15|0.9033
72507781|NCT00390780|144547281|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority statistical analysis for ITT population.|difference in proportion mycologic cure|0.15||||0.5816|ONE_SIDED|95.0|-0.15|||Significance level was \<0.025.|Chi-squared||||||-0.15|0.5816
72507782|NCT00390780|144547281|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority statistical analysis for PP population|difference in proportion mycologic cure|0.15||||0.4439|ONE_SIDED|95.0|-0.15|||Significance level was \<0.025.|Chi-squared||||||-0.15|0.4439
72507783|NCT00390780|144547282|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority statistical analysis for ITT population.|difference in proportion relapsed|0.15||||0.833|ONE_SIDED|95.0|-0.15|||Significance level is \<0.025.|Chi-squared||||||-0.15|0.8330
72507784|NCT00390780|144547282|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority statistical analysis for PP population.|difference in proportion relapsed|0.15||||0.9738|ONE_SIDED|95.0|-0.15|||Significance level is \<0.025.|Chi-squared||||||-0.15|0.9738
72507785|NCT00390780|144547287|SUPERIORITY_OR_OTHER|||||||0.186||95.0|||||Wilcoxon (Mann-Whitney)|||Analysis for Clotrimazole minimum inhibitory concentration (MIC) between treatment groups||||0.1860
72507786|NCT00390780|144547287|SUPERIORITY_OR_OTHER|||||||0.9564||95.0|||||Wilcoxon (Mann-Whitney)|||Analysis for Miconazole minimum inhibitory concentration (MIC) between treatment groups||||0.9564
72507787|NCT00109733|144547289|SUPERIORITY_OR_OTHER|||||||0.177|||||||ANOVA|||"The null hypothesis (% change in trunk fat (kg) from baseline to Wk24 within the treatment group = 0) was tested against the alternative hypothesis (% change in trunk fat (kg) from baseline to Wk24 within the treatment group ≠0).~P-Values for testing this hypothesis for each treatment group are from an analysis of variance (ANOVA) model on ranked data with effects for treatment group, gender and their interaction."||||0.177
72475852|NCT01468181|144477513|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.7||||0.4|TWO_SIDED|65.0|-5.68|2.27|||t-test, 2 sided|p-values are from within-group change t-test at the level of 0.05||HOMA2-S% at 52 Weeks||2.27|-5.68|0.400
72475853|NCT04828837|144477514|SUPERIORITY|The intervention effect was evaluated using the generalized estimating equation (GEE) statistical method. Two-tailed tests were conducted, and p-values less than .05 were considered statistically significant.|Mean Difference (Final Values)|0.39|||<|0.05|TWO_SIDED|95.0||||We used Mann-Whitney U test for independent samples, and Fisher's exact tests when more than 20% of cells have expected frequencies \<5 or less than 10 observations to examine the homogeneity between groups based on demographic characteristics.|Wilcoxon (Mann-Whitney)|||Descriptive statistics, including count, percentage, mean, and standard deviation, were used to summarize the data.||||<0.05
72507788|NCT00109733|144547289|SUPERIORITY_OR_OTHER|||||||0.004|||||||ANOVA|||"The null hypothesis (% change in trunk fat (kg) from baseline to Wk24 within the treatment group = 0) was tested against the alternative hypothesis (% change in trunk fat (kg) from baseline to Wk24 within the treatment group ≠0).~P-Values for testing this hypothesis for each treatment group are from an analysis of variance (ANOVA) model on ranked data with effects for treatment group, gender and their interaction."||||0.004
72507789|NCT00109733|144547290|SUPERIORITY_OR_OTHER|||||||0.004|||||||ANOVA|||"The null hypothesis (% change in lean body mass (kg) from baseline to Wk24 within the treatment group = 0) was tested against the alternative hypothesis (% change in lean body mass (kg) from baseline to Wk24 within the treatment group ≠0).~P-Values for testing this hypothesis for each treatment group are from an analysis of variance (ANOVA) model on ranked data with effects for treatment group, gender and their interaction."||||0.004
72507790|NCT00109733|144547290|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA|||"The null hypothesis (% change in lean body mass (kg) from baseline to Wk24 within the treatment group = 0) was tested against the alternative hypothesis (% change in lean body mass (kg) from baseline to Wk24 within the treatment group ≠0).~P-Values for testing this hypothesis for each treatment group are from an analysis of variance (ANOVA) model on ranked data with effects for treatment group, gender and their interaction."||||<0.001
72507791|NCT00109733|144547291|SUPERIORITY_OR_OTHER|||||||0.653|||||||ANOVA|||"The null hypothesis (% change in total body fat (kg) from baseline to Wk24 within the treatment group = 0) was tested against the alternative hypothesis (% change in total body fat (kg) from baseline to Wk24 within the treatment group ≠0).~P-Values for testing this hypothesis for each treatment group are from an analysis of variance (ANOVA) model on ranked data with effects for treatment group, gender and their interaction."||||0.653
72566261|NCT01523587|144663154|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.99||||0.869|TWO_SIDED|95.0|0.82|1.18||p-value calculated using log rank test stratified by race|Regression, Cox||Hazard ratio (Afatinib vs Erlotinib) from Cox proportional hazard model stratified by race.|The results shown relate to Time to Deterioration in Pain||1.18|0.82|0.8690
72399187|NCT03742037|144304982|SUPERIORITY||LS mean difference to placebo|-0.39|STANDARD_ERROR_OF_MEAN|0.54||0.4749|TWO_SIDED|95.0|-1.45|0.68|||Mixed Models Analysis|||The analysis was performed on the Full Analysis Set (FAS). The FAS included all participants who were randomized. Baseline was defined as the last measurement before randomization.||0.68|-1.45|0.4749
72399188|NCT03742037|144304982|SUPERIORITY||LS mean to placebo|-0.57|STANDARD_ERROR_OF_MEAN|0.54||0.2941|TWO_SIDED|95.0|-1.65|0.49|||Mixed Models Analysis|||The analysis was performed on the Full Analysis Set (FAS). The FAS included all participants who were randomized. Baseline was defined as the last measurement before randomization.||0.49|-1.65|0.2941
72399189|NCT03742037|144304982|SUPERIORITY||LS mean difference to placebo|0.01|STANDARD_ERROR_OF_MEAN|0.54||0.9802|TWO_SIDED|95.0|-1.05|1.08|||Mixed Models Analysis|||The analysis was performed on the Full Analysis Set (FAS). The FAS included all participants who were randomized. Baseline was defined as the last measurement before randomization.||1.08|-1.05|0.9802
72399190|NCT03742037|144304982|SUPERIORITY||LS mean difference|-1.19|STANDARD_ERROR_OF_MEAN|0.54||0.0291|TWO_SIDED|95.0|-2.25|-0.12|||Mixed Models Analysis|||The analysis was performed on the Full Analysis Set (FAS). The FAS included all participants who were randomized. Baseline was defined as the last measurement before randomization.||-0.12|-2.25|0.0291
72507792|NCT00109733|144547291|SUPERIORITY_OR_OTHER|||||||0.002|||||||ANOVA|||"The null hypothesis (% change in total body fat (kg) from baseline to Wk24 within the treatment group = 0) was tested against the alternative hypothesis (% change in total body fat (kg) from baseline to Wk24 within the treatment group ≠0).~P-Values for testing this hypothesis for each treatment group are from an analysis of variance (ANOVA) model on ranked data with effects for treatment group, gender and their interaction."||||0.002
72507793|NCT00109733|144547292|SUPERIORITY_OR_OTHER|||||||0.755|||||||ANOVA|||"The null hypothesis (% change in limb fat (kg) from baseline to Wk24 within the treatment group = 0) was tested against the alternative hypothesis (% change in limb fat (kg) from baseline to Wk24 within the treatment group ≠0).~P-Values for testing this hypothesis for each treatment group are from an analysis of variance (ANOVA) model on ranked data with effects for treatment group, gender and their interaction."||||0.755
72507794|NCT00109733|144547292|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA|||"The null hypothesis (% change in limb fat (kg) from baseline to Wk24 within the treatment group = 0) was tested against the alternative hypothesis (% change in limb fat (kg) from baseline to Wk24 within the treatment group ≠0).~P-Values for testing this hypothesis for each treatment group are from an analysis of variance (ANOVA) model on ranked data with effects for treatment group, gender and their interaction."||||<0.001
72566262|NCT01523587|144663155|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.5|STANDARD_ERROR_OF_MEAN|1.34||0.0091|TWO_SIDED|95.0|-6.15|-0.88|||Regression, Cox|||The results shown relate to Change in scores over time for: Coughing.||-0.88|-6.15|0.0091
72566263|NCT01523587|144663155|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.5|STANDARD_ERROR_OF_MEAN|1.15||0.0024|TWO_SIDED|95.0|-5.75|-1.25|||Regression, Cox|||The results shown relate to Change in scores over time for: Dyspnoea.||-1.25|-5.75|0.0024
72566264|NCT01523587|144663155|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.7|STANDARD_ERROR_OF_MEAN|1.32||0.0384|TWO_SIDED|95.0|-5.33|-0.15|||Regression, Cox|||The results shown relate to Change in scores over time for: Pain.||-0.15|-5.33|0.0384
72566265|NCT04070287|144663156|SUPERIORITY||||||<|0.05|||||||Chi-squared|||||||<0.05
72623199|NCT03977155|144777036|SUPERIORITY||Mean Difference (Net)|24.0|STANDARD_ERROR_OF_MEAN|29.087|||TWO_SIDED|95.0|-34.22|82.22||||||Statistical Analysis 2||82.22|-34.22|
72475854|NCT04828837|144477515|SUPERIORITY|The intervention effect was evaluated using the generalized estimating equation (GEE) statistical method. Two-tailed tests were conducted, and p-values less than .05 were considered statistically significant.|||||<|0.05||||||We used Mann-Whitney U test for independent samples, and Fisher's exact tests when more than 20% of cells have expected frequencies \<5 or less than 10 observations to examine the homogeneity between groups based on demographic characteristics.|The generalized estimating equation (GEE|||Descriptive statistics, including count, percentage, mean, and standard deviation, were used to summarize the data.||||<0.05
72475855|NCT04828837|144477516|SUPERIORITY|The intervention effect was evaluated using the generalized estimating equation (GEE) statistical method. Two-tailed tests were conducted, and p-values less than .05 were considered statistically significant.|||||<|0.05||||||We used Mann-Whitney U test for independent samples, and Fisher's exact tests when more than 20% of cells have expected frequencies \<5 or less than 10 observations to examine the homogeneity between groups based on demographic characteristics.|The generalized estimating equation (GEE|||Descriptive statistics, including count, percentage, mean, and standard deviation, were used to summarize the data.||||<0.05
72475856|NCT04828837|144477517|SUPERIORITY||||||<|0.05|||||||Chi-squared|||||||<0.05
72566266|NCT04070287|144663157|SUPERIORITY||||||<|0.05|||||||Chi-squared|||||||<0.05
72475857|NCT05453201|144477564|OTHER|||||||0.06|||||||paired t-test|||This analysis uses the functional disability subscale from pre- to post-intervention.||||.06
72475858|NCT05453201|144477564|OTHER|||||||0.004|||||||paired t-test|||This analysis uses the symptom severity subscale from pre- to post-intervention.||||.004
72475859|NCT05453201|144477564|OTHER|||||||0.1|||||||paired t-test|||This analysis uses the perceived overall health now subscale (1 item) from pre- to post-intervention.||||.10
72475860|NCT05453201|144477565|OTHER|||||||0.46|||||||paired t-test|||This analysis uses domain 1 from pre- to post-intervention.||||.46
72475861|NCT05453201|144477565|OTHER|||||||0.2|||||||paired t-test|||This analysis uses domain 2 from pre- to post-intervention.||||.20
72475862|NCT05453201|144477565|OTHER|||||||0.42|||||||paired t-test|||This analysis uses domain 3 from pre- to post-intervention.||||.42
72475863|NCT05453201|144477565|OTHER|||||||0.84|||||||paired t-test|||This analysis uses domain 4 from pre- to post-intervention.||||.84
72475864|NCT05453201|144477565|OTHER|||||||0.25|||||||paired t-test|||This analysis uses domain 5 (part 1) from pre- to post-intervention.||||.25
72475865|NCT05453201|144477565|OTHER|||||||0.26|||||||paired t-test|||This analysis uses domain 6 from pre- to post-intervention.||||.26
72475866|NCT05453201|144477566|OTHER|||||||0.89|||||||Wilcoxon test|||This analysis uses the SBQ-R total score from pre- to post-intervention.||||.89
72475867|NCT05453201|144477567|OTHER|||||||0.8|||||||paired t-test|||This analysis uses the MOCS (part A) from pre- to post-intervention.||||.80
72623200|NCT03977155|144777036|SUPERIORITY||Mean Difference (Net)|-33.42|STANDARD_ERROR_OF_MEAN|27.285|||TWO_SIDED|95.0|-87.91|21.07||||||Statistical Analysis 3||21.07|-87.91|
72475868|NCT05453201|144477568|OTHER|||||||0.92|||||||paired t-test|||This analysis uses the FSCQ score (all items) from pre- to post-intervention.||||.92
72475869|NCT05453201|144477568|OTHER|||||||0.9|||||||Wilcoxon test (paired)|||This analysis uses the FSCQ similarity subscale from pre- to post-intervention.||||.90
72475870|NCT05453201|144477568|OTHER|||||||0.74|||||||paired t-test|||This analysis uses the FSCQ vividness subscale from pre- to post-intervention.||||.74
72475871|NCT05453201|144477568|OTHER|||||||0.44|||||||paired t-test|||This analysis uses the FSCQ positivity subscale from pre- to post-intervention.||||.44
72475872|NCT05453201|144477569|OTHER|||||||0.003|||||||paired t-test|||This analysis uses the PHQ-9 from pre- to post-intervention.||||.003
72475873|NCT05453201|144477570|OTHER|||||||0.01|||||||paired t-test|||This analysis uses the GAD-7 from pre- to post-intervention.||||.01
72475874|NCT05453201|144477571|OTHER|||||||0.04|||||||paired t-test|||This analysis uses the QOLS from pre- to post-intervention.||||.04
72566267|NCT04070287|144663158|SUPERIORITY||||||<|0.05|||||||Chi-squared|||||||<0.05
72566268|NCT04070287|144663159|SUPERIORITY||||||<|0.05|||||||Chi-squared|||||||<0.05
72623201|NCT03977155|144777036|SUPERIORITY||Mean Difference (Net)|57.42|STANDARD_ERROR_OF_MEAN|28.174|||TWO_SIDED|95.0|1.16|113.69||||||Statistical Analysis 4||113.69|1.16|
72507795|NCT00109733|144547293|SUPERIORITY_OR_OTHER|||||||0.041|||||||ANOVA|||"The null hypothesis (% change in trunk to limb fat ratio from baseline to Wk24 within the treatment group = 0) was tested against the alternative hypothesis (% change in trunk to limb fat ratio from baseline to Wk24 within the treatment group ≠0).~P-Values for testing this hypothesis for each treatment group are from an analysis of variance (ANOVA) model on ranked data with effects for treatment group, gender and their interaction."||||0.041
72507796|NCT00109733|144547293|SUPERIORITY_OR_OTHER|||||||0.044|||||||ANOVA|||"The null hypothesis (% change in trunk to limb fat ratio from baseline to Wk24 within the treatment group = 0) was tested against the alternative hypothesis (% change in trunk to limb fat ratio from baseline to Wk24 within the treatment group ≠0).~P-Values for testing this hypothesis for each treatment group are from an analysis of variance (ANOVA) model on ranked data with effects for treatment group, gender and their interaction."||||0.044
72507797|NCT04964063|144547328|OTHER||Mean Difference (Final Values)|-1.33|STANDARD_ERROR_OF_MEAN|0.08|<|0.0001|TWO_SIDED|95.0|-1.47|-1.19|||ANOVA||Q1: How intense are the sensation|||-1.19|-1.47|<.0001
72507798|NCT04964063|144547328|OTHER||Mean Difference (Final Values)|-1.61|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001|TWO_SIDED|95.0|-1.77|-1.45|||ANOVA||Q2: How bothered are you by any sensation|||-1.45|-1.77|<.0001
72507799|NCT04964063|144547328|OTHER||Mean Difference (Final Values)|-1.17|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001|TWO_SIDED|95.0|-1.33|-1.0|||ANOVA||Q3: How well can you tolerate sensations|||-1.00|-1.33|<.0001
72507800|NCT04964063|144547329|OTHER||Median Difference (Final Values)|-1.84|STANDARD_ERROR_OF_MEAN|0.08|<|0.0001|TWO_SIDED|95.0|-1.98|-1.7|||ANOVA||Q1: How intense are the sensation|||-1.70|-1.98|<.0001
72399191|NCT03742037|144304983|SUPERIORITY||Odds Ratio (OR)|1.01||||0.974|TWO_SIDED|95.0|0.54|1.9|||Mixed Models Analysis|||A generalized mixed effects model for repeated measures was applied to the SRI-4 response from Month 1 through 6 with treatment group, month, treatment group by month interaction, and stratification factors (oral corticosteroids dose \& mSLEDAI-2K) as fixed effects \& participant as random effect.||1.9|0.54|0.974
72399192|NCT03742037|144304983|SUPERIORITY||Odds Ratio (OR)|1.42||||0.2845|TWO_SIDED|95.0|0.75|2.65|||Mixed Models Analysis|||A generalized mixed effects model for repeated measures was applied to the SRI-4 response from Month 1 through 6 with treatment group, month, treatment group by month interaction, and stratification factors (oral corticosteroids dose \& mSLEDAI-2K) as fixed effects \& participant as random effect.||2.65|0.75|0.2845
72566269|NCT04070287|144663160|SUPERIORITY||||||<|0.05|||||||Chi-squared|||||||<0.05
72566270|NCT04070287|144663161|SUPERIORITY||||||<|0.05|||||||Chi-squared|||||||<0.05
72566271|NCT00606502|144663166|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|0.84|||||TWO_SIDED|95.0|0.61|1.14||||||||1.14|0.61|
72507801|NCT04964063|144547329|OTHER||Mean Difference (Final Values)|-2.17|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001|TWO_SIDED|95.0|-2.33|-2.02|||ANOVA||Q2: How bothered are you by any sensation|||-2.02|-2.33|<.0001
72507802|NCT04964063|144547329|OTHER||Mean Difference (Final Values)|-1.45|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001|TWO_SIDED|95.0|-1.61|-1.29|||ANOVA||Q3: How well can you tolerate sensations|||-1.29|-1.61|<.0001
72507803|NCT04964063|144547330|OTHER||Mean Difference (Final Values)|-2.29|STANDARD_ERROR_OF_MEAN|0.08|<|0.0001|TWO_SIDED|95.0|-2.43|-2.15|||ANOVA||Q1: How intense are the sensation|||-2.15|-2.43|<.0001
72507804|NCT04964063|144547330|OTHER||Mean Difference (Final Values)|-2.63|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001|TWO_SIDED|95.0|-2.79|-2.47|||ANOVA||Q2: How bothered are you by any sensation|||-2.47|-2.79|<.0001
72507805|NCT04964063|144547330|OTHER||Mean Difference (Final Values)|-1.86|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001|TWO_SIDED|95.0|-2.02|-1.7|||ANOVA||Q3: How well can you tolerate sensations|||-1.70|-2.02|<.0001
72507806|NCT04964063|144547331|OTHER||Mean Difference (Final Values)|-2.54|STANDARD_ERROR_OF_MEAN|0.08|<|0.0001|TWO_SIDED|95.0|-2.68|-2.4|||ANOVA||Q1: How intense are the sensation|||-2.40|-2.68|<.0001
72566272|NCT03438227|144663181|SUPERIORITY|||||||0.039|||||||Chi-squared|||||||0.039
72566273|NCT03438227|144663182|SUPERIORITY|||||||0.019|||||||t-test, 2 sided|||||||0.019
72566274|NCT03438227|144663183|SUPERIORITY|||||||0.029|||||||Fisher Exact|||||||0.029
72399193|NCT03742037|144304983|SUPERIORITY||Odds Ratio (OR)|1.23||||0.5115|TWO_SIDED|95.0|0.66|2.32|||Mixed Models Analysis|||A generalized mixed effects model for repeated measures was applied to the SRI-4 response from Month 1 through 6 with treatment group, month, treatment group by month interaction, and stratification factors (oral corticosteroids dose \& mSLEDAI-2K) as fixed effects \& participant as random effect.||2.32|0.66|0.5115
72507807|NCT04964063|144547331|OTHER||Mean Difference (Final Values)|-2.89|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001|TWO_SIDED|95.0|-3.05|-2.73|||ANOVA||Q2: How bothered are you by any sensation|||-2.73|-3.05|<.0001
72507808|NCT04964063|144547331|OTHER||Mean Difference (Final Values)|-2.04|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001|TWO_SIDED|95.0|-2.2|-1.87|||ANOVA||Q3: How well can you tolerate sensations|||-1.87|-2.20|<.0001
72566275|NCT03438227|144663184|SUPERIORITY|||||||0.029|||||||Fisher Exact|||||||0.029
72566276|NCT03438227|144663185|SUPERIORITY|||||||0.19|||||||t-test, 2 sided|||||||0.19
72566277|NCT03438227|144663186|SUPERIORITY|||||||0.194|||||||Fisher Exact|||||||0.194
72566278|NCT03438227|144663187|SUPERIORITY|||||||0.414|||||||Chi-squared|||||||0.414
72566279|NCT03438227|144663188|SUPERIORITY|||||||0.15|||||||t-test, 2 sided|||||||0.15
72566280|NCT03438227|144663189|SUPERIORITY|||||||0.571|||||||t-test, 2 sided|||||||0.571
72566281|NCT03438227|144663190|SUPERIORITY|||||||0.12|||||||t-test, 2 sided|||||||0.12
72566282|NCT03438227|144663191|SUPERIORITY|||||||0.049|||||||Log Rank|||||||0.049
72566283|NCT03438227|144663192|SUPERIORITY|||||||0.933|||||||t-test, 2 sided|||||||0.933
72566284|NCT03438227|144663193|SUPERIORITY|||||||0.66|||||||Fisher Exact|||||||0.66
72566285|NCT03438227|144663194|SUPERIORITY|||||||0.633|||||||t-test, 2 sided|||||||0.633
72576829|NCT00261443|144680657|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.18||||0.152|TWO_SIDED|95.0|-0.42|0.07||Baseline: ANOVA model, controlling for treatment, mood stabilizer, and index mood episode. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 44 Comparison||0.07|-0.42|0.152
72507809|NCT04964063|144547332|OTHER||Mean Difference (Final Values)|-2.69|STANDARD_ERROR_OF_MEAN|0.08|<|0.0001|TWO_SIDED|95.0|-2.84|-2.55|||ANOVA||Q1: How intense are the sensation|||-2.55|-2.84|<.0001
72399194|NCT03742037|144304983|SUPERIORITY||Odds Ratio (OR)|1.23||||0.5115|TWO_SIDED|95.0|0.66|2.32|||Mixed Models Analysis|||A generalized mixed effects model for repeated measures was applied to the SRI-4 response from Month 1 through 6 with treatment group, month, treatment group by month interaction, and stratification factors (oral corticosteroids dose \& mSLEDAI-2K) as fixed effects \& participant as random effect.||2.32|0.66|0.5115
72399195|NCT04600414|144305017|SUPERIORITY||Odds Ratio (OR)|0.1|||<|0.001|TWO_SIDED|95.0|0.03|0.38|||Multi-level model to account for cluster|||||0.38|0.03|<0.001
72399196|NCT04600414|144305018|SUPERIORITY||Mean Difference (Final Values)|-1.2||||0.532|TWO_SIDED|95.0|-4.97|2.57|||Multi-level model to account for cluster|||||2.57|-4.97|0.532
72507810|NCT04964063|144547332|OTHER||Mean Difference (Final Values)|-2.99|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001|TWO_SIDED|95.0|-3.15|-2.83|||ANOVA||Q2: How bothered are you by any sensation|||-2.83|-3.15|<.0001
72507811|NCT04964063|144547332|OTHER||Mean Difference (Final Values)|-2.18|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001|TWO_SIDED|95.0|-2.35|-2.02|||ANOVA||Q3: How well can you tolerate sensations|||-2.02|-2.35|<.0001
72507812|NCT04964063|144547333|OTHER||Median Difference (Final Values)|-2.94|STANDARD_ERROR_OF_MEAN|0.08|<|0.0001|TWO_SIDED|95.0|-3.08|-2.79|||ANOVA||Q1: How intense are the sensation|||-2.79|-3.08|<.0001
72507813|NCT04964063|144547333|OTHER||Median Difference (Final Values)|-3.24|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001|TWO_SIDED|95.0|-3.4|-3.08|||ANOVA||Q2: How bothered are you by any sensation|||-3.08|-3.40|<.0001
72507814|NCT04964063|144547333|OTHER||Mean Difference (Final Values)|-2.37|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001|TWO_SIDED|95.0|-2.53|-2.21|||ANOVA||Q3: How well can you tolerate sensations|||-2.21|-2.53|<.0001
72507815|NCT04964063|144547335|OTHER||Mean Difference (Final Values)|-17.93|STANDARD_ERROR_OF_MEAN|1.91|<|0.0001|TWO_SIDED|95.0|-20.81|-15.05|||ANOVA|||||-15.05|-20.81|<.0001
72507816|NCT04964063|144547336|OTHER||Mean Difference (Final Values)|-31.2|STANDARD_ERROR_OF_MEAN|1.9|<|0.0001|TWO_SIDED|95.0|-34.04|-28.36|||ANOVA|||||-28.36|-34.04|<.0001
72399204|NCT01499563|144305143|SUPERIORITY||Least Squares Mean Difference|-5.8|STANDARD_ERROR_OF_MEAN|2.4||0.017|TWO_SIDED|95.0|-11.1|-0.4|||Mixed Effects model for Repeated Measure||95% CI for LS Mean difference are with Bonferroni correction|The study was powered for prespecified comparison of both doses of ITI-007 with placebo using a Bonferroni correction for multiple comparisons. The study was not statistically powered to include multiple comparisons of risperidone to placebo and thus, this comparison is not presented here.||-0.4|-11.1|0.017
72399205|NCT01499563|144305143|SUPERIORITY||Least Squares Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|2.4||0.708|TWO_SIDED|95.0|-6.3|4.5|||Mixed Effects Model for Repeated Measure||95% CI for LS Mean difference are with Bonferroni correction|The study was powered for prespecified comparison of both doses of ITI-007 with placebo using a Bonferroni correction for multiple comparisons. The study was not statistically powered to include multiple comparisons of risperidone to placebo and thus, this comparison is not presented here.||4.5|-6.3|0.708
72507817|NCT04964063|144547337|OTHER||Mean Difference (Final Values)|-39.45|STANDARD_ERROR_OF_MEAN|1.9|<|0.0001|TWO_SIDED|95.0|-42.3|-36.59|||ANOVA|||||-36.59|-42.30|<.0001
72507818|NCT04964063|144547338|OTHER||Mean Difference (Final Values)|-44.37|STANDARD_ERROR_OF_MEAN|1.91|<|0.0001|TWO_SIDED|95.0|-47.24|-41.49|||ANOVA|||||-41.49|-47.24|<.0001
72507819|NCT04964063|144547339|OTHER||Mean Difference (Final Values)|-48.04|STANDARD_ERROR_OF_MEAN|1.93|<|0.0001|TWO_SIDED|95.0|-50.96|-45.12|||ANOVA|||||-45.12|-50.96|<.0001
72475875|NCT05453201|144477572|OTHER|"The AIM measures an intervention's acceptability. Therefore, the goal is not change over time, the goal is to assess, descriptively, post-intervention acceptability. Because we assessed this measure at baseline (with expectations of the future treatment), we provide a paired t-test with the AIM at pre- and post-intervention."||||||0.24|||||||Paired t-test|||||||.24
72475876|NCT05453201|144477572|OTHER|"The IAM measures an intervention's appropriateness. Therefore, the goal is not change over time, the goal is to assess, descriptively, post-intervention appropriateness. Because we assessed this measure at baseline (with expectations of the future treatment), we provide a paired t-test with the IAM at pre- and post-intervention."||||||0.82|||||||Paired t-test|||||||.82
72475877|NCT05453201|144477572|OTHER|||||||0.38|||||||Paired t-test|||"The FIM measures an intervention's feasibility. Therefore, the goal is not change over time, the goal is to assess, descriptively, post-intervention feasibility. Because we assessed this measure at baseline (with expectations of the future treatment), we provide a paired t-test with the FIM at pre- and post-intervention."||||.38
72475878|NCT04688320|144477577|NON_INFERIORITY|The margin of the non-inferiority was established as a difference in the primary efficacy endpoints between compared groups|Odds Ratio (OR)|0.75|||<|0.05|TWO_SIDED|95.0|0.11|4.52|||Welch's t-test|||||4.52|0.11|<0.05
72475879|NCT01200290|144477591|SUPERIORITY_OR_OTHER|||||||0.324|TWO_SIDED|||||P-value is for Week 8.|Mixed Effect Model Repeat Measurement|||||||0.324
72475880|NCT01200290|144477591|SUPERIORITY_OR_OTHER|||||||0.031|TWO_SIDED|||||P-value is for Week 16.|Mixed Effect Model Repeat Measurement|||||||0.031
72475881|NCT01200290|144477591|SUPERIORITY_OR_OTHER|||||||0.076|TWO_SIDED|||||P-value is for Week 24.|Mixed Effect Model Repeat Measurement|||||||0.076
72507820|NCT04964063|144547340|OTHER||Mean Difference (Final Values)|-52.47|STANDARD_ERROR_OF_MEAN|1.91|<|0.0001|TWO_SIDED|95.0|-55.33|-49.62|||ANOVA|||||-49.62|-55.33|<.0001
72507821|NCT04964063|144547342|OTHER||Mean Difference (Final Values)|-2.45|STANDARD_ERROR_OF_MEAN|0.26|<|0.0001|TWO_SIDED|95.0|-2.88|-2.02|||ANOVA|||||-2.02|-2.88|<.0001
72507822|NCT04964063|144547343|OTHER||Mean Difference (Final Values)|-4.27|STANDARD_ERROR_OF_MEAN|0.25|<|0.0001|TWO_SIDED|95.0|-4.69|-3.85|||ANOVA|||||-3.85|-4.69|<.0001
72475882|NCT01200290|144477591|SUPERIORITY_OR_OTHER|||||||0.013|TWO_SIDED|||||P-value is for Week 36.|Mixed Effect Model Repeat Measurement|||||||0.013
72475883|NCT01200290|144477591|SUPERIORITY_OR_OTHER|||||||0.553|TWO_SIDED|||||P-value is for Week 52.|Mixed Effect Model Repeat Measurement|||||||0.553
72475884|NCT01200290|144477591|SUPERIORITY_OR_OTHER|||||||0.132|TWO_SIDED|||||P-value is for Week 64.|Mixed Effect Model Repeat Measurement|||||||0.132
72475885|NCT01200290|144477591|SUPERIORITY_OR_OTHER|||||||0.23|TWO_SIDED|||||P-value is for Week 76.|Mixed Effect Model Repeat Measurement|||||||0.230
72475886|NCT01200290|144477592|SUPERIORITY_OR_OTHER|||||||0.335|TWO_SIDED|||||P-value is for Week 8.|Mixed Effect Model Repeat Measurement|||||||0.335
72507823|NCT04964063|144547344|OTHER||Mean Difference (Final Values)|-5.71|STANDARD_ERROR_OF_MEAN|0.25|<|0.0001|TWO_SIDED|95.0|-6.13|-5.28|||ANOVA|||||-5.28|-6.13|<.0001
72507824|NCT04964063|144547345|OTHER||Mean Difference (Final Values)|-6.45|STANDARD_ERROR_OF_MEAN|0.26|<|0.0001|TWO_SIDED|95.0|-6.88|-6.02|||ANOVA|||||-6.02|-6.88|<.0001
72475887|NCT01200290|144477592|SUPERIORITY_OR_OTHER|||||||0.043|TWO_SIDED|||||P-value is for Week 16.|Mixed Effect Model Repeat Measurement|||||||0.043
72475888|NCT01200290|144477592|SUPERIORITY_OR_OTHER|||||||0.073|TWO_SIDED|||||P-value is for Week 24.|Mixed Effect Model Repeat Measurement|||||||0.073
72475889|NCT01200290|144477592|SUPERIORITY_OR_OTHER|||||||0.004|TWO_SIDED|||||P-value is for Week 36.|Mixed Effect Model Repeat Measurement|||||||0.004
72475890|NCT01200290|144477592|SUPERIORITY_OR_OTHER|||||||0.699|TWO_SIDED|||||P-value is for Week 52.|Mixed Effect Model Repeat Measurement|||||||0.699
72475891|NCT01200290|144477592|SUPERIORITY_OR_OTHER|||||||0.095|TWO_SIDED|||||P-value is for Week 64.|Mixed Effect Model Repeat Measurement|||||||0.095
72475892|NCT01200290|144477592|SUPERIORITY_OR_OTHER|||||||0.082|TWO_SIDED|||||P-value is for Week 76.|Mixed Effect Model Repeat Measurement|||||||0.082
72475893|NCT00728910|144477599|SUPERIORITY_OR_OTHER||||||>|0.5|TWO_SIDED||||||Mixed Models Analysis|||Null hypothesis was that the sequential addition of a fibrate and niacin to baseline atorvastatin therapy would not have any effect on apo-AI catabolism.||||>0.5
72475894|NCT00728910|144477600|SUPERIORITY_OR_OTHER||||||>|0.5|TWO_SIDED||||||Mixed Models Analysis|||The null hypothesis was that sequential addition of fibrate and niacin to baseline atorvastatin therapy would have no effect on apo-A1 production rates||||>0.5
72475895|NCT00728910|144477601|SUPERIORITY_OR_OTHER||||||<|0.0005|TWO_SIDED||||||Mixed Models Analysis|||Null hypothesis was that sequential addition of fibrate and niacin to baseline atorvastatin therapy would have no effect on post-prandial triglyceride levels following an oral fat load||||<0.0005
72475896|NCT00728910|144477601|SUPERIORITY_OR_OTHER||||||<|0.0005|TWO_SIDED||||||Mixed Models Analysis|||||||<0.0005
72475897|NCT04155203|144477602|EQUIVALENCE|The primary efficacy endpoint was the proportion of subjects in each treatment group with clinical cure, defined as a SIRS score of 0 for all signs and symptoms at Visit 4/Follow-up (7 days after the end of treatment).|equivalence ratio|0.97|||||TWO_SIDED|90.0|-8.19|2.7||||||||2.70|-8.19|
72507825|NCT04964063|144547346|OTHER||Median Difference (Final Values)|-7.01|STANDARD_ERROR_OF_MEAN|0.26|<|0.0001|TWO_SIDED|95.0|-7.45|-6.58|||ANOVA|||||-6.58|-7.45|<.0001
72507826|NCT04964063|144547347|OTHER||Mean Difference (Final Values)|-7.44|STANDARD_ERROR_OF_MEAN|0.25|<|0.0001|TWO_SIDED|95.0|-7.87|-7.01|||ANOVA|||||-7.01|-7.87|<.0001
72507827|NCT04964063|144547349|OTHER||Mean Difference (Final Values)|-6.33|STANDARD_ERROR_OF_MEAN|0.72|<|0.0001|TWO_SIDED|95.0|-7.46|-5.2|||ANOVA|||||-5.20|-7.46|<.0001
72475898|NCT02489968|144477610|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.82|STANDARD_ERROR_OF_MEAN|0.08|<|0.0001|TWO_SIDED|95.0|-0.97|-0.67|||REML based MMRM|Model including baseline HbA1c, treatment, baseline renal function, prior use of antidiabetic drug, visit, and visit by treatment interaction.|Adjusted mean difference: Change in HbA1c in (empagliflozin 10 mg + linagliptin 5 mg) - change in HbA1c in (empagliflozin 10 mg + placebo)|||-0.67|-0.97|<0.0001
72475899|NCT02489968|144477610|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.59|STANDARD_ERROR_OF_MEAN|0.07|<|0.0001|TWO_SIDED|95.0|-0.73|-0.45|||REML based MMRM|Model including baseline HbA1c, treatment, baseline renal function, prior use of antidiabetic drug, visit, and visit by treatment interaction.|Adjusted mean difference: Change in HbA1c in (empagliflozin 25 mg + linagliptin 5 mg) - change in HbA1c in (empagliflozin 25 mg + placebo)|||-0.45|-0.73|<0.0001
72475900|NCT01241604|144477617|EQUIVALENCE|Equivalent non-parametric tests||||||0.753|||||||Wilcoxon signed ranks test|||||||.753
72507828|NCT04964063|144547350|OTHER||Mean Difference (Final Values)|-11.53|STANDARD_ERROR_OF_MEAN|0.72|<|0.0001|TWO_SIDED|95.0|-12.64|-10.41|||ANOVA|||||-10.41|-12.64|<.0001
72507829|NCT04964063|144547351|OTHER||Mean Difference (Final Values)|-14.54|STANDARD_ERROR_OF_MEAN|0.72|<|0.0001|TWO_SIDED|95.0|-15.66|-13.42|||ANOVA|||||-13.42|-15.66|<.0001
72507830|NCT04964063|144547352|OTHER||Median Difference (Final Values)|-16.54|STANDARD_ERROR_OF_MEAN|0.72|<|0.0001|TWO_SIDED|95.0|-17.67|-15.41|||ANOVA|||||-15.41|-17.67|<.0001
72507831|NCT04964063|144547353|OTHER||Mean Difference (Final Values)|-17.73|STANDARD_ERROR_OF_MEAN|0.73|<|0.0001|TWO_SIDED|95.0|-18.87|-16.58|||ANOVA|||||-16.58|-18.87|<.0001
72507832|NCT04964063|144547354|OTHER||Mean Difference (Final Values)|-18.84|STANDARD_ERROR_OF_MEAN|0.72|<|0.0001|TWO_SIDED|95.0|-19.96|-17.72|||ANOVA|||||-17.72|-19.96|<.0001
72566286|NCT02697773|144663255|SUPERIORITY|Step-down testing procedure within each of the primary endpoints was applied to maintain Type I error. Tanezumab 2.5/5 mg vs placebo was tested first and if found significant, then the testing was continued for Tanezumab 2.5 mg vs placebo. Tanezumab treatment group was declared as superior to placebo if the corresponding treatment contrast was significant over all 3 primary endpoints.|Least Square Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.24||0.0129|TWO_SIDED|95.0|-1.07|-0.13||Threshold for significance at 0.05 level.|ANCOVA|||Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain subscale and baseline diary average pain as covariates, and study site as a random effect.||-0.13|-1.07|0.0129
72475901|NCT01865747|144477646|SUPERIORITY||Hazard Ratio (HR)|0.58|||<|0.0001|TWO_SIDED|95.0|0.45|0.74|||Log Rank|The Log-Rank Test was stratified by the Memorial Sloan-Kettering Cancer Center (MSKCC) group and number of prior VEGFR TKIs.||||0.74|0.45|<0.0001
72507833|NCT04964063|144547356|OTHER||Mean Difference (Final Values)|-2.04|STANDARD_ERROR_OF_MEAN|0.31|<|0.0001|TWO_SIDED|95.0|-2.52|-1.56|||ANOVA|||||-1.56|-2.52|<.0001
72475902|NCT01865747|144477647|SUPERIORITY||Hazard Ratio (HR)|0.66||||0.0003|TWO_SIDED|95.0|0.53|0.83|||Log Rank|The Log-Rank test was stratified by the Memorial Sloan-Kettering Cancer Center (MSKCC) risk group and number of prior VEGFR TKIs.||||0.83|0.53|0.0003
72475903|NCT01865747|144477648|SUPERIORITY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
72507834|NCT04964063|144547357|OTHER||Mean Difference (Final Values)|-3.69|STANDARD_ERROR_OF_MEAN|0.31|<|0.0001|TWO_SIDED|95.0|-4.17|-3.22|||ANOVA|||||-3.22|-4.17|<.0001
72507835|NCT04964063|144547358|OTHER||Mean Difference (Final Values)|-4.67|STANDARD_ERROR_OF_MEAN|0.31|<|0.0001|TWO_SIDED|95.0|-5.15|-4.2|||ANOVA|||||-4.20|-5.15|<.0001
72507836|NCT04964063|144547359|OTHER||Mean Difference (Final Values)|-5.24|STANDARD_ERROR_OF_MEAN|0.31|<|0.0001|TWO_SIDED|95.0|-5.72|-4.76|||ANOVA|||||-4.76|-5.72|<.0001
72507837|NCT04964063|144547360|OTHER||Mean Difference (Final Values)|-5.63|STANDARD_ERROR_OF_MEAN|0.32|<|0.0001|TWO_SIDED|95.0|-6.12|-5.14|||ANOVA|||||-5.14|-6.12|<.0001
72507838|NCT04964063|144547361|OTHER||Mean Difference (Final Values)|-6.24|STANDARD_ERROR_OF_MEAN|0.31|<|0.0001|TWO_SIDED|95.0|-6.72|-5.77|||ANOVA|||||-5.77|-6.72|<.0001
72507839|NCT04964063|144547363|OTHER||Mean Difference (Final Values)|-5.25|STANDARD_ERROR_OF_MEAN|0.48|<|0.0001|TWO_SIDED|95.0|-6.06|-4.44|||ANOVA|||||-4.44|-6.06|<.0001
72507840|NCT04964063|144547364|OTHER||Mean Difference (Final Values)|-8.52|STANDARD_ERROR_OF_MEAN|0.47|<|0.0001|TWO_SIDED|95.0|-9.32|-7.72|||ANOVA|||||-7.72|-9.32|<.0001
72507841|NCT04964063|144547365|OTHER||Mean Difference (Final Values)|-10.55|STANDARD_ERROR_OF_MEAN|0.48|<|0.0001|TWO_SIDED|95.0|-11.35|-9.75|||ANOVA|||||-9.75|-11.35|<.0001
72507842|NCT04964063|144547366|OTHER||Mean Difference (Final Values)|-11.6|STANDARD_ERROR_OF_MEAN|0.48|<|0.0001|TWO_SIDED|95.0|-12.41|-10.79|||ANOVA|||||-10.79|-12.41|<.0001
72507843|NCT04964063|144547367|OTHER||Mean Difference (Final Values)|-12.63|STANDARD_ERROR_OF_MEAN|0.48|<|0.0001|TWO_SIDED|95.0|-13.45|-11.81|||ANOVA|||||-11.81|-13.45|<.0001
72507844|NCT04964063|144547368|OTHER||Mean Difference (Final Values)|-13.88|STANDARD_ERROR_OF_MEAN|0.48|<|0.0001|TWO_SIDED|95.0|-14.69|-13.08|||ANOVA|||||-13.08|-14.69|<.0001
72507845|NCT04964063|144547370|OTHER||Mean Difference (Final Values)|-1.88|STANDARD_ERROR_OF_MEAN|0.35|<|0.0001|TWO_SIDED|95.0|-2.43|-1.33|||ANOVA|||||-1.33|-2.43|<.0001
72507846|NCT04964063|144547371|OTHER||Mean Difference (Final Values)|-3.2|STANDARD_ERROR_OF_MEAN|0.35|<|0.0001|TWO_SIDED|95.0|-3.74|-2.65|||ANOVA|||||-2.65|-3.74|<.0001
72507847|NCT04964063|144547372|OTHER||Mean Difference (Final Values)|-3.98|STANDARD_ERROR_OF_MEAN|0.35|<|0.0001|TWO_SIDED|95.0|-4.53|-3.44|||ANOVA|||||-3.44|-4.53|<.0001
72507848|NCT04964063|144547373|OTHER||Mean Difference (Final Values)|-4.55|STANDARD_ERROR_OF_MEAN|0.35|<|0.0001|TWO_SIDED|95.0|-5.1|-4.0|||ANOVA|||||-4.00|-5.10|<.0001
72507849|NCT04964063|144547374|OTHER||Median Difference (Final Values)|-5.04|STANDARD_ERROR_OF_MEAN|0.36|<|0.0001|TWO_SIDED|95.0|-5.6|-4.48|||ANOVA|||||-4.48|-5.60|<.0001
72507850|NCT04964063|144547375|OTHER||Mean Difference (Final Values)|-6.07|STANDARD_ERROR_OF_MEAN|0.35|<|0.0001|TWO_SIDED|95.0|-6.62|-5.53|||ANOVA|||||-5.53|-6.62|<.0001
72507851|NCT04964063|144547377|OTHER||Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.04||0.1091|TWO_SIDED|95.0|-0.12|0.01|||ANOVA|||||0.01|-0.12|0.1091
72507852|NCT04964063|144547378|OTHER||Mean Difference (Final Values)|-0.13|STANDARD_ERROR_OF_MEAN|0.04|<|0.0001|TWO_SIDED|95.0|-0.19|-0.06|||ANOVA|||||-0.06|-0.19|<.0001
72507853|NCT04964063|144547379|OTHER||Mean Difference (Final Values)|-0.16|STANDARD_ERROR_OF_MEAN|0.04|<|0.0001|TWO_SIDED|95.0|-0.23|-0.1|||ANOVA|||||-0.10|-0.23|<.0001
72507854|NCT04964063|144547380|OTHER||Mean Difference (Final Values)|-0.17|STANDARD_ERROR_OF_MEAN|0.04|<|0.0001|TWO_SIDED|95.0|-0.24|-0.11|||ANOVA|||||-0.11|-0.24|<.0001
72507855|NCT04964063|144547381|OTHER||Median Difference (Final Values)|-0.19|STANDARD_ERROR_OF_MEAN|0.04|<|0.0001|TWO_SIDED|95.0|-0.26|-0.13|||ANOVA|||||-0.13|-0.26|<.0001
72507856|NCT04964063|144547382|OTHER||Mean Difference (Final Values)|-0.25|STANDARD_ERROR_OF_MEAN|0.04|<|0.0001|TWO_SIDED|95.0|-0.31|-0.18|||ANOVA|||||-0.18|-0.31|<.0001
72507857|NCT04964063|144547384|OTHER||Mean Difference (Final Values)|-1.7|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-1.95|-1.45|||ANOVA|||||-1.45|-1.95|<.0001
72507858|NCT04964063|144547385|OTHER||Mean Difference (Final Values)|-2.69|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-2.94|-2.44|||ANOVA|||||-2.44|-2.94|<.0001
72507859|NCT04964063|144547386|OTHER||Mean Difference (Final Values)|-3.09|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-3.35|-2.84|||ANOVA|||||-2.84|-3.35|<.0001
72623202|NCT03977155|144777037|SUPERIORITY|Individual BOS-589 dose levels versus placebo were only to be tested if pooled BOS-589 doses versus placebo was significant at p\<0.05.|Mean Difference (Net)|-0.17|STANDARD_ERROR_OF_MEAN|0.137||0.2149|TWO_SIDED|95.0|-0.44|0.1|||t test|P-values were calculated from the independent two-sample t test with equal variance.||Statistical Analysis 1||0.10|-0.44|0.2149
72507860|NCT04964063|144547387|OTHER||Mean Difference (Final Values)|-3.44|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-3.69|-3.19|||ANOVA|||||-3.19|-3.69|<.0001
72507861|NCT04964063|144547388|OTHER||Median Difference (Final Values)|-3.8|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-4.06|-3.55|||ANOVA|||||-3.55|-4.06|<.0001
72507862|NCT04964063|144547389|OTHER||Mean Difference (Final Values)|-4.26|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-4.51|-4.0|||ANOVA|||||-4.00|-4.51|<.0001
72507863|NCT01035606|144547391|SUPERIORITY||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||||||<.01
72507864|NCT01035606|144547392|SUPERIORITY||||||<|0.01|||||||t-test, 2 sided|||||||<.01
72507865|NCT01397071|144547393|OTHER||Mean Difference (Final Values)|2.2||||0.052|TWO_SIDED|95.0|||||t-test, 2 sided|||Comparison of change in PAT measurements was made to beef alone vs. beef with avocado 2 hours post-ingestion||||0.052
72507866|NCT01397071|144547394|OTHER||% of baseline|0.58||||0.03|TWO_SIDED|||||Significance is defined as p\<0.05.|t-test, 2 sided|||Comparison was made to beef patty alone vs. beef patty with avocado added 3 hours post-ingestion.||||0.03
72507867|NCT03350750|144547395|SUPERIORITY||ANCOVA Model Effect (Open vs. Closed)|0.22||||0.071|TWO_SIDED|95.0|-0.02|0.46|||ANCOVA||This is the coefficient for an indicator variable comparing the Open versus Closed shunt group, in a linear regression model with Month 4 gait velocity as the outcome and Baseline gait velocity included as a predictor along with treatment.|||0.46|-0.02|0.071
72507868|NCT03350750|144547396|SUPERIORITY|||||||0.337|||||||ANCOVA|||||||0.337
72507869|NCT03350750|144547397|SUPERIORITY|||||||0.007|||||||ANCOVA|||||||0.007
72507870|NCT03350750|144547398|SUPERIORITY|||||||0.201|||||||ANCOVA|||||||0.201
72507871|NCT03350750|144547399|SUPERIORITY|||||||0.172|||||||ANCOVA|||||||0.172
72507872|NCT03350750|144547400|SUPERIORITY|||||||0.78|||||||ANCOVA|||||||0.780
72507873|NCT03350750|144547401|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
72507874|NCT03350750|144547402|SUPERIORITY|||||||0.24|||||||t-test, 2 sided|||||||0.240
72507875|NCT03350750|144547403|SUPERIORITY|||||||0.013|||||||t-test, 2 sided|||||||0.013
72507876|NCT03350750|144547404|SUPERIORITY|||||||0.019|||||||t-test, 2 sided|||||||0.019
72507877|NCT03350750|144547405|SUPERIORITY|||||||0.04|||||||t-test, 2 sided|||||||0.040
72507878|NCT03350750|144547406|SUPERIORITY|||||||0.013|||||||t-test, 2 sided|||||||0.013
72507879|NCT03350750|144547407|SUPERIORITY|||||||0.235|||||||Fisher Exact|Fisher's exact test with a mid-p-value correction||||||0.235
72507880|NCT02433288|144547410|SUPERIORITY_OR_OTHER|||||||0.0019|||||||Log Rank|||||||0.0019
72507881|NCT02433288|144547411|SUPERIORITY_OR_OTHER|||||||0.0017|||||||Chi-squared|||||||0.0017
72507882|NCT02433288|144547412|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-20.24|STANDARD_ERROR_OF_MEAN|3.39|<|0.0001|TWO_SIDED|95.0|-26.91|-13.57|||t-test, 2 sided|||||-13.57|-26.91|<0.0001
72507883|NCT02433288|144547413|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.38|STANDARD_ERROR_OF_MEAN|1.6||0.3939|TWO_SIDED|95.0|-4.56|1.8|||t-test, 2 sided|||||1.80|-4.56|0.3939
72507884|NCT02433288|144547414|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.63|STANDARD_ERROR_OF_MEAN|1.99||0.7514|TWO_SIDED|95.0|-3.27|4.53|||ANCOVA|linear model including terms for randomized group and baseline LDL-C||||4.53|-3.27|0.7514
72507885|NCT01849250|144547415|SUPERIORITY|||||||0.5|||||||ANCOVA|||||||.50
72507886|NCT01849250|144547418|SUPERIORITY|||||||0.19|||||||ANCOVA|||||||.19
72507887|NCT01849250|144547419|SUPERIORITY|||||||0.52|||||||ANOVA|||||||.52
72507888|NCT01849250|144547420|SUPERIORITY|||||||0.12|||||||ANCOVA|||||||.12
72507889|NCT00367640|144547422|SUPERIORITY_OR_OTHER|||||||0.0006|TWO_SIDED|||||ANCOVA of the average RTSS, with treatment and pooled sites as factors, and retrospective RTSS, asthma and sensitised status as covariates.|ANCOVA|||A step-down approach is performed to address the multiplicity issue.||||0.0006
72475904|NCT03465904|144477666|SUPERIORITY|Our power analysis indicated that a minimum of 239 patients per group was needed to provide 90% power to detect a 13.4% difference in the primary outcome, pain freedom at 2 h. Accounting for an estimated attrition rate of 20%, we aimed to enroll 299 patients per group.|||||<|0.05||||||All analyses were performed using SPSS, version 26.0 with two-sided levels of statistical significance established at p \< 0.05|Chi-squared|A Chi-square test of independent proportions was used to compare primary and secondary efficacy outcomes between groups.||Identical statistical analyses were performed for the intent-to-treat (ITT) and the per protocol (PP) populations. The ITT population consisted of all randomized patients, who received any duration of sham or verum treatment and returned completed study materials. The PP population consisted of patients who strictly met inclusion criteria and completed at least 60 min of treatment.||||<0.05
72475905|NCT01209234|144477687|SUPERIORITY||Cox Proportional Hazard|0.7|STANDARD_ERROR_OF_MEAN|0.024||0.026|TWO_SIDED|95.0|0.52|0.96|||Regression, Cox||This is the estimated standard error of the log hazard ratio|||0.96|0.52|0.026
72475906|NCT01209234|144477688|SUPERIORITY||Cox Proportional Hazard|0.84|STANDARD_ERROR_OF_MEAN|0.009||0.061|TWO_SIDED|95.0|0.7|1.01||Not adjusted for multiple comparisons|Regression, Cox||CDC-defined all-cause infection secondary outcome This is the estimated standard error of the log hazard ratio|||1.01|0.70|0.061
72475907|NCT01209234|144477688|SUPERIORITY||Cox Proportional Hazard|0.83|STANDARD_ERROR_OF_MEAN|0.008||0.035|TWO_SIDED|95.0|0.7|0.99||Not adjusted for multiple comparisons|Regression, Cox||Clinical criteria for all-cause infection This is the estimated standard error of the log hazard ratio|||0.99|0.70|0.035
72475908|NCT00591721|144477697|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.53|STANDARD_DEVIATION|6.47|<|0.05|TWO_SIDED|95.0|-15.47|10.41|||t-test, 2 sided|Each baseline subscale score was subtracted from 7 week subscale score; t-tests assessed mean individual differences between groups.||Hypothesis: Individuals who participate in the program will report significantly reduced fatigue impact immediately post-intervention compared to individuals allocated to the wait-list control group.||10.41|-15.47|<0.05
72475909|NCT02716818|144477698|SUPERIORITY||Mean Difference (Final Values)|-0.069|||=|0.5521|TWO_SIDED|95.0|-0.299|0.161|||ANCOVA|||The primary efficacy variable was the natural logarithm of the mean of the 24-hour SDS profile for the natural logarithm of 17-OHP. The SDS profile was calculated as the SDS of log transformed 17-OHP concentration unsigned. The mean of the 24-hour SDS profile for each visit was the arithmetic mean of all the SDSs, with the first and last (13th) weighted one half relative to the intermediate SDSs.||0.161|-0.299|=0.5521
72623203|NCT03977155|144777037|SUPERIORITY||Mean Difference (Net)|0.01|STANDARD_ERROR_OF_MEAN|0.141|||TWO_SIDED|95.0|-0.27|0.29||||||Statistical Analysis 2||0.29|-0.27|
72475910|NCT02716818|144477699|SUPERIORITY||Mean Difference (Final Values)|0.047|||=|0.7405|TWO_SIDED|95.0|-0.234|0.329|||ANCOVA|||Change from Baseline to 24 Weeks in A4 Using an ANCOVA Model - The analysis conducted for the primary endpoint variable analysis of 17-OHP was repeated for A4.||0.329|-0.234|=0.7405
72475911|NCT02716818|144477700|SUPERIORITY||Mean Difference (Final Values)|-0.037|||=|0.8186|TWO_SIDED|95.0|-0.354|0.281|||ANCOVA|||||0.281|-0.354|=0.8186
72507890|NCT00367640|144547422|SUPERIORITY_OR_OTHER|||||||0.0001|TWO_SIDED|||||ANCOVA of the average RTSS, with treatment and pooled sites as factors, and retrospective RTSS, asthma and sensitised status as covariates.|ANCOVA|||A step-down approach is performed to address the multiplicity issue.||||0.0001
72507891|NCT00367640|144547422|SUPERIORITY_OR_OTHER|||||||0.4606|TWO_SIDED|||||ANCOVA of the average RTSS, with treatment and pooled sites as factors, and retrospective RTSS, asthma and sensitised status as covariates.|ANCOVA|||A step-down approach is performed to address the multiplicity issue.||||0.4606
72507892|NCT01525849|144547459|NON_INFERIORITY_OR_EQUIVALENCE|Significance level=0.025 (1-sided alpha), power=90%, delta=0.8, true difference=0, SD for both arms=1.0. A total sample size of 72 participants (36 per arm) was required to test the hypothesis.|||||<|0.001|||||||t-test, 1 sided|||Non-inferiority test to demonstrate that the long-term (1-year) change in sinus symptoms (overall SNOT-20 score) after balloon dilation is not worse than after FESS.||||<0.001
72507893|NCT01525849|144547460|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 1 sided|||Test for superiority of balloon dilation over FESS. Significance level=0.025 (1-sided alpha), power=90%, BD estimate=0.5, FESS estimate=1.5, SD for both arms=1.0. A total sample size of 46 participants (23 per arm) was required to test the hypothesis.||||<0.0001
72475912|NCT02716818|144477700|SUPERIORITY||Mean Difference (Final Values)|-0.135|||=|0.4655|TWO_SIDED|95.0|-0.508|0.237|||ANCOVA|||||0.237|-0.508|=0.4655
72475913|NCT02716818|144477700|SUPERIORITY||Mean Difference (Final Values)|0.065|||=|0.9081|TWO_SIDED|95.0|-1.32|1.451|||ANCOVA|||||1.451|-1.32|=0.9081
72475914|NCT02716818|144477700|SUPERIORITY||Median Difference (Final Values)|0.092|||=|0.6729|TWO_SIDED|95.0|-0.343|0.527|||ANCOVA|||||0.527|-0.343|=0.6729
72475915|NCT02716818|144477700|SUPERIORITY||Mean Difference (Final Values)|0.116|||=|0.5322|TWO_SIDED|95.0|-0.257|0.489|||ANCOVA|||||0.489|-0.257|=0.5322
72475916|NCT02716818|144477700|SUPERIORITY||Mean Difference (Final Values)|-0.568|||=|0.2885|TWO_SIDED|95.0|-1.799|0.662|||ANCOVA|||||0.662|-1.799|=0.2885
72475917|NCT02716818|144477701|SUPERIORITY||Odds Ratio (OR)|0.99|||=|0.9877|TWO_SIDED|95.0|0.45|2.19|||Regression, Logistic|||||2.19|0.45|=0.9877
72475918|NCT02716818|144477701|SUPERIORITY||Odds Ratio (OR)|0.93|||=|0.8498|TWO_SIDED|95.0|0.43|2.02|||Regression, Logistic|||||2.02|0.43|=0.8498
72475919|NCT02716818|144477702|SUPERIORITY||Mean Difference (Final Values)|-0.96|||=|0.156|TWO_SIDED|95.0|-2.294|0.374|||ANCOVA|||German subjects have been excluded from this analysis group as DEXA scans are not performed at German sites.||0.374|-2.294|=0.156
72475920|NCT02716818|144477702|SUPERIORITY||Median Difference (Final Values)|0.425|||=|0.3392|TWO_SIDED|95.0|-0.455|1.305|||ANCOVA|||German subjects have been excluded from this analysis group as DEXA scans are not performed at German sites.||1.305|-0.455|=0.3392
72475921|NCT02716818|144477703|SUPERIORITY||Median Difference (Final Values)|0.009|||=|0.2614|TWO_SIDED|95.0|-0.007|0.025|||ANCOVA|||||0.025|-0.007|=0.2614
72507894|NCT01525849|144547461|SUPERIORITY_OR_OTHER|||||||0.628|||||||t-test, 2 sided|||||||0.628
72507895|NCT01525849|144547463|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
72623204|NCT03977155|144777037|SUPERIORITY||Mean Difference (Net)|-0.32|STANDARD_ERROR_OF_MEAN|0.159|||TWO_SIDED|95.0|-0.64|-0.01||||||Statistical Analysis 3||-0.01|-0.64|
72507896|NCT02142894|144547473|EQUIVALENCE|The results are analyzed in a 2x2 contingency table with 95%CI.|2 x 2 contingency table|87.9|||||TWO_SIDED|95.0|72.7|95.2||||||||95.2|72.7|
72566287|NCT02697773|144663255|SUPERIORITY|Step-down testing procedure within each of the primary endpoints was applied to maintain Type I error. Tanezumab 2.5/5 mg vs placebo was tested first and if found significant, then the testing was continued for Tanezumab 2.5 mg vs placebo. Tanezumab treatment group was declared as superior to placebo if the corresponding treatment contrast was significant over all 3 primary endpoints.|Least Square Mean Difference|-0.73|STANDARD_ERROR_OF_MEAN|0.24||0.0023|TWO_SIDED|95.0|-1.2|-0.26||Threshold for significance at 0.05 level.|ANCOVA|||Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain subscale and baseline diary average pain as covariates, and study site as a random effect.||-0.26|-1.20|0.0023
72566288|NCT02697773|144663256|SUPERIORITY|Step-down testing procedure within each of the primary endpoints was applied to maintain Type I error. Tanezumab 2.5/5 mg vs placebo was tested first and if found significant, then the testing was continued for Tanezumab 2.5 mg vs placebo. Tanezumab treatment group was declared as superior to placebo if the corresponding treatment contrast was significant over all 3 primary endpoints.|Least Square Mean Difference|-0.66|STANDARD_ERROR_OF_MEAN|0.24||0.0065|TWO_SIDED|95.0|-1.14|-0.19||Threshold for significance at 0.05 level.|ANCOVA|||Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed data sets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariates, and study site as a random effect.||-0.19|-1.14|0.0065
72566289|NCT02697773|144663256|SUPERIORITY|Step-down testing procedure within each of the primary endpoints was applied to maintain Type I error. Tanezumab 2.5/5 mg vs placebo was tested first and if found significant, then the testing was continued for Tanezumab 2.5 mg vs placebo. Tanezumab treatment group was declared as superior to placebo if the corresponding treatment contrast was significant over all 3 primary endpoints.|Least Square Mean Difference|-0.89|STANDARD_ERROR_OF_MEAN|0.24||0.0002|TWO_SIDED|95.0|-1.37|-0.42||Threshold for significance at 0.05 level.|ANCOVA|||Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariates, and study site as a random effect.||-0.42|-1.37|0.0002
72566290|NCT02697773|144663257|SUPERIORITY|Step-down testing procedure within each of the primary endpoints was applied to maintain Type I error. Tanezumab 2.5/5 mg vs placebo was tested first and if found significant, then the testing was continued for Tanezumab 2.5 mg vs placebo. Tanezumab treatment group was declared as superior to placebo if the corresponding treatment contrast was significant over all 3 primary endpoints.|Least Square Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.09||0.0109|TWO_SIDED|95.0|-0.39|-0.05||Threshold for significance at 0.05 level.|ANCOVA|||Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline PGA of osteoarthritis and baseline diary average pain as covariates, and study site as a random effect.||-0.05|-0.39|0.0109
72566291|NCT02697773|144663257|SUPERIORITY|Step-down testing procedure within each of the primary endpoints was applied to maintain Type I error. Tanezumab 2.5/5 mg vs placebo was tested first and if found significant, then the testing was continued for Tanezumab 2.5 mg vs placebo. Tanezumab treatment group was declared as superior to placebo if the corresponding treatment contrast was significant over all 3 primary endpoints.|Least Square Mean Difference|-0.25|STANDARD_ERROR_OF_MEAN|0.09||0.0038|TWO_SIDED|95.0|-0.41|-0.08||Threshold for significance at 0.05 level.|ANCOVA|||Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline PGA of osteoarthritis and baseline diary average pain as covariates, and study site as a random effect.||-0.08|-0.41|0.0038
72623205|NCT03977155|144777037|SUPERIORITY||Mean Difference (Net)|0.33|STANDARD_ERROR_OF_MEAN|0.16|||TWO_SIDED|95.0|0.02|0.65||||||Statistical Analysis 4||0.65|0.02|
72623206|NCT00775658|144777042|SUPERIORITY_OR_OTHER|||||||0.57|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||Before the study, we determined that a sample size of 18 would be adequate to detect a 20% difference in wheal and flare areas with 80% power and a significance level of 0.05.||||0.57
72623207|NCT00775658|144777043|SUPERIORITY|Sample size determined that 18 participants would provide 80% power to detect a 20% difference with a significance level of 0.05.||||||0.09|||||||Wilcoxon (Mann-Whitney)|||||||0.09
72507897|NCT00257192|144547482|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|-1.8|STANDARD_ERROR_OF_MEAN|1.26||0.153|TWO_SIDED|95.0|-4.28|0.67||Mixed effects repeated measures (MMRM) analysis of covariance model with subject as random effect, treatment, region, visit and visit-by-treatment interaction as fixed effects and baseline score as a covariate.|ANCOVA|P-value for final analysis is to be adjusted due to planned interim analysis (0.0462).||Sample size for 85% power 2-tailed 0.05 significance level based on expected difference of -5 with average within-group standard deviation=13 was 276 subjects (2 to 1 ratio of enrollment: 184 ziprasidone, 92 placebo). Interim analysis at 60 percent (%) enrollment (ITT population): may stop trial early for efficacy (2-sided p-value less than (\<) 0.0124) or for futility (2-sided p-value greater than (\>) 0.4772; The final analysis is to employ a 2-sided p-value \<0.0462.||0.67|-4.28|0.1530
72399219|NCT05247229|144305265|SUPERIORITY||Slope|0.37||||0.05|TWO_SIDED|95.0|0.0|0.73|||Chi-squared|||Q10 Difference between pre- and post-program surveys from generalized estimating equation linear regressions accounting for clustering of longitudinal observations within person, adjusted associations and 95% confidence intervals.||0.73|0.00|0.05
72475922|NCT00581555|144477710|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|7.5||0.999|TWO_SIDED|95.0|-14.7|14.7||P-values were not adjusted for multiplicity and the priori threshold for statistical significance was 0.05.|mixed model of ANCOVA|Treatment groups and visits were fixed factors, participant was a random factor and baseline was covariate.||Analysis at randomization to Week 8.||14.7|-14.7|0.999
72475923|NCT00581555|144477710|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.0|STANDARD_ERROR_OF_MEAN|7.5||0.795|TWO_SIDED|95.0|-12.8|16.7||P-values were not adjusted for multiplicity and the priori threshold for statistical significance was 0.05.|mixed model of ANCOVA|Treatment groups and visits were fixed factors, participant was a random factor and baseline was covariate.||Analysis at randomization to Week 10.||16.7|-12.8|0.795
72475924|NCT00581555|144477710|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.3|STANDARD_ERROR_OF_MEAN|7.6||0.758|TWO_SIDED|95.0|-12.5|17.1||P-values were not adjusted for multiplicity and the priori threshold for statistical significance was 0.05.|mixed model of ANCOVA|Treatment groups and visits were fixed factors, participant was a random factor and baseline was covariate.||Analysis at randomization to Week 12.||17.1|-12.5|0.758
72475925|NCT00581555|144477710|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.7|STANDARD_ERROR_OF_MEAN|7.6||0.381|TWO_SIDED|95.0|-8.3|21.6||P-values were not adjusted for multiplicity and the priori threshold for statistical significance was 0.05.|mixed model of ANCOVA|Treatment groups and visits were fixed factors, participant was a random factor and baseline was covariate.||Analysis at randomization to Week 16.||21.6|-8.3|0.381
72475926|NCT00581555|144477710|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.1|STANDARD_ERROR_OF_MEAN|7.8||0.041|TWO_SIDED|95.0|0.8|31.4||P-values were not adjusted for multiplicity and the priori threshold for statistical significance was 0.05.|mixed model of ANCOVA|Treatment groups and visits were fixed factors, participant was a random factor and baseline was a covariate.||Analysis at randomization to Week 20.||31.4|0.8|0.041
72475927|NCT00581555|144477710|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|30.5|STANDARD_ERROR_OF_MEAN|8.0|<|0.001|TWO_SIDED|95.0|14.8|46.3||P-values were not adjusted for multiplicity and the priori threshold for statistical significance was 0.05.|mixed model of ANCOVA|Treatment groups and visits were fixed factors, participant was a random factor and baseline was covariate.||Analysis at randomization to Week 24.||46.3|14.8|<0.001
72475928|NCT00581555|144477711|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.6|STANDARD_ERROR_OF_MEAN|0.3||0.049|TWO_SIDED|95.0|0.0|1.2||P-values were not adjusted for multiplicity and the priori threshold for statistical significance was 0.05.|mixed model of ANCOVA|Treatment groups and visits were fixed factors, participant was a random factor and baseline was a covariate.||Analysis from randomization to Week 24.||1.2|0.0|0.049
72507898|NCT00257192|144547483|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|-0.21|STANDARD_ERROR_OF_MEAN|0.14||0.1289|TWO_SIDED|95.0|-0.48|0.06||Mixed effects repeated measures (MMRM) analysis of covariance model with subject as random effect, treatment, region, visit and visit-by-treatment interaction as fixed effects and baseline score as a covariate.|ANCOVA|Hochberg procedure was applied to p-value to preserve type I error in the analysis of key secondary endpoints (PANSS total score and CGI-S).||Difference from placebo||0.06|-0.48|0.1289
72623208|NCT05796245|144777083|OTHER|Estimation|Cox Proportional Hazard|1.43|||||TWO_SIDED|95.0|0.39|5.2|||||Hazard Ratio of Exposed/Reference, where Exposed is Infliximab-Pfizer Biosimilar and Reference is Remicade.|Comparative analysis set, IPTW weighted||5.20|0.39|
72399220|NCT05247229|144305265|SUPERIORITY||Slope|0.22||||0.36|TWO_SIDED|95.0|-0.25|0.7|||Chi-squared|||Q13 Difference between pre- and post-program surveys from generalized estimating equation linear regressions accounting for clustering of longitudinal observations within person, adjusted associations and 95% confidence intervals.||0.70|-0.25|0.36
72475929|NCT00581555|144477712|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||P-values were not adjusted for multiplicity and the priori threshold for statistical significance was 0.05.|Pearson chi-square|Treatment groups and visits were fixed factors with a logit link, a binomial distribution and an auto-regressive correlation structure.||Analysis from randomization to Week 24.||||0.002
72475930|NCT00581555|144477713|SUPERIORITY_OR_OTHER|||||||0.0003||95.0|||||Log Rank|Time to first relapse was estimated using the Kaplan-Meier's, and comparisons between groups was performed using log rank tests.||||||0.0003
72475931|NCT00581555|144477714|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.7|STANDARD_ERROR_OF_MEAN|1.3|<|0.001|TWO_SIDED|95.0|2.1|7.3||P-values were not adjusted for multiplicity and the priori threshold for statistical significance was 0.05.|mixed model of ANCOVA|Treatment groups and visits were fixed factors, participant was a random factor and baseline was a covariate.||Analysis from randomization to Week 24.||7.3|2.1|<0.001
72475932|NCT00581555|144477715|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|135.2|STANDARD_ERROR_OF_MEAN|42.3||0.001|TWO_SIDED|95.0|52.3|218.1||P-values were not adjusted for multiplicity and the priori threshold for statistical significance was 0.05.|mixed model of ANCOVA|Treatment groups and visits were fixed factors, participant was a random factor and baseline was a covariate.||Analysis from randomization to Week 24.||218.1|52.3|0.001
72475933|NCT00581555|144477716|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.4|STANDARD_ERROR_OF_MEAN|1.6||0.139||95.0|-0.8|5.5||P-values were not adjusted for multiplicity and the priori threshold for statistical significance was 0.05.|mixed model of ANCOVA|Treatment groups and visits were fixed factors, participant was a random factor and baseline was a covariate.||Analysis from randomization to Week 24.||5.5|-0.8|0.139
72475934|NCT00581555|144477717|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|1.2||0.956|TWO_SIDED|95.0|-2.3|2.5||P-values were not adjusted for multiplicity and the priori threshold for statistical significance was 0.05.|mixed model of ANCOVA|Treatment groups and visits were fixed factors, participant was a random factor and baseline was a covariate.||Analysis from baseline to Week 2.||2.5|-2.3|0.956
72475935|NCT00581555|144477717|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.1|STANDARD_ERROR_OF_MEAN|1.3||0.41|TWO_SIDED|95.0|-3.6|1.5||P-values were not adjusted for multiplicity and the priori threshold for statistical significance was 0.05.|mixed model of ANCOVA|Treatment groups and visits were fixed factors, participant was a random factor and baseline was a covariate.||Analysis from baseline to Week 4.||1.5|-3.6|0.41
72507899|NCT00257192|144547484|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|-2.57|STANDARD_ERROR_OF_MEAN|2.0||0.1987||95.0|-6.5|1.36||Mixed effects repeated measures (MMRM) analysis of covariance model with subject as random effect, treatment, region, visit and visit-by-treatment interaction as fixed effects and baseline score as a covariate.|ANCOVA|Hochberg procedure was applied to p-value to preserve type I error in the analysis of key secondary endpoints (PANSS total score and CGI-S).||Total score: difference from placebo||1.36|-6.50|0.1987
72507900|NCT00257192|144547485|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|-1.33|STANDARD_ERROR_OF_MEAN|0.65||0.0412|TWO_SIDED|95.0|-2.61|-0.05||Mixed effects repeated measures (MMRM) analysis of covariance model with subject as random effect, treatment, region, visit, and visit-by-treatment interaction as fixed effects and baseline score as a covariate.|ANCOVA|||Positive score: difference from placebo||-0.05|-2.61|0.0412
72507901|NCT00257192|144547485|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|-0.43|STANDARD_ERROR_OF_MEAN|0.58||0.4661|TWO_SIDED|95.0|-1.57|0.72||Mixed effects repeated measures (MMRM) analysis of covariance model with subject as random effect, treatment, region, visit, and visit-by-treatment interaction as fixed effects and baseline score as a covariate.|ANCOVA|||Negative score: difference from placebo||0.72|-1.57|0.4661
72507902|NCT00257192|144547486|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|-0.19|STANDARD_ERROR_OF_MEAN|0.14||0.182|TWO_SIDED|95.0|-0.47|0.09||Mixed effects MMRM with subject as random effect, treatment, region, visit and visit-by-treatment interaction as fixed effects.|ANOVA|||Difference from placebo||0.09|-0.47|0.1820
72507903|NCT00257192|144547494|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|1.34|STANDARD_ERROR_OF_MEAN|1.19||0.2613|TWO_SIDED|95.0|-1.01|3.69||SAS PROC MIXED to fit a mixed model analysis of covariance with treatment and region as fixed effects and baseline score as covariate.|ANCOVA|Observed cases at Week 6.||Neurocognitive Index score at Week 6: difference from placebo||3.69|-1.01|0.2613
72507904|NCT00570739|144547503|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.15||||0.0123|TWO_SIDED|95.0|-0.27|-0.03||P-Value is for the LS mean difference between treatment groups|ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||Baseline to 4 weeks||-0.03|-0.27|0.0123
72507905|NCT00570739|144547503|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.18||||0.0201|TWO_SIDED|95.0|-0.33|-0.03||P-Value is for the LS Mean Difference between treatment groups.|ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||Baseline to 8 Weeks||-0.03|-0.33|0.0201
72507906|NCT00570739|144547503|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.19||||0.0239|TWO_SIDED|95.0|-0.36|-0.03||P-Value is for the LS Mean Difference between treatment groups.|ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||Baseline to 12 weeks||-0.03|-0.36|0.0239
72475936|NCT00581555|144477717|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|2.2||0.844|TWO_SIDED|95.0|-4.8|3.9||P-values were not adjusted for multiplicity and the priori threshold for statistical significance was 0.05.|mixed model of ANCOVA|Treatment groups and visits were fixed factors, participant was a random factor and baseline was a covariate.||Analysis from baseline to Week 6.||3.9|-4.8|0.844
72475937|NCT00581555|144477717|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.9||0.968|TWO_SIDED|95.0|-1.8|1.8||P-values were not adjusted for multiplicity and the priori threshold for statistical significance was 0.05.|mixed model of ANCOVA|Treatment groups and visits were fixed factors, participant was a random factor and baseline was a covariate.||Analysis from baseline to Week 8.||1.8|-1.8|0.968
72475938|NCT00581555|144477717|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.7|STANDARD_ERROR_OF_MEAN|0.9||0.441|TWO_SIDED|95.0|-1.1|2.5||P-values were not adjusted for multiplicity and the priori threshold for statistical significance was 0.05.|mixed model of ANCOVA|Treatment groups and visits were fixed factors, participant was a random factor and baseline was a covariate.||Analysis from baseline to Week 10.||2.5|-1.1|0.441
72475939|NCT00581555|144477717|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.0|STANDARD_ERROR_OF_MEAN|0.9||0.3|TWO_SIDED|95.0|-0.9|2.8||P-values were not adjusted for multiplicity and the priori threshold for statistical significance was 0.05.|mixed model of ANCOVA|Treatment groups and visits were fixed factors, participant was a random factor and baseline was a covariate.||Analysis from baseline to Week 12.||2.8|-0.9|0.3
72475940|NCT00581555|144477717|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.6|STANDARD_ERROR_OF_MEAN|1.0||0.008|TWO_SIDED|95.0|0.7|4.5||P-values were not adjusted for multiplicity and the priori threshold for statistical significance was 0.05.|mixed model of ANCOVA|Treatment groups and visits were fixed factors, participant was a random factor and baseline was a covariate.||Analysis from baseline to Week 16.||4.5|0.7|0.008
72507907|NCT00570739|144547503|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.25||||0.0046|TWO_SIDED|95.0|-0.42|-0.08||P-Value is for the LS Mean Difference between treatment groups.|ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||Baseline to 16 weeks||-0.08|-0.42|0.0046
72507908|NCT00570739|144547504|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.1||||0.1112|TWO_SIDED|95.0|-11.3|1.2|||ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||Baseline to 4 Weeks||1.2|-11.3|0.1112
72507909|NCT00570739|144547504|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.3||||0.2167|TWO_SIDED|95.0|-8.6|2.0|||ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||Baseline to 8 Weeks||2.0|-8.6|0.2167
72507910|NCT00570739|144547504|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.1||||0.7269|TWO_SIDED|95.0|-7.0|4.9|||ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||Baseline to 12 weeks||4.9|-7.0|0.7269
72475941|NCT00581555|144477717|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.0|STANDARD_ERROR_OF_MEAN|1.0||0.005|TWO_SIDED|95.0|0.9|5.0||P-values were not adjusted for multiplicity and the priori threshold for statistical significance was 0.05.|mixed model of ANCOVA|Treatment groups and visits were fixed factors, participant was a random factor and baseline was a covariate.||Analysis from baseline to Week 20.||5.0|0.9|0.005
72475942|NCT00581555|144477717|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.4|STANDARD_ERROR_OF_MEAN|1.1||0.031|TWO_SIDED|95.0|0.2|4.6||P-values were not adjusted for multiplicity and the priori threshold for statistical significance was 0.05.|mixed model of ANCOVA|Treatment groups and visits were fixed factors, participant was a random factor and baseline was a covariate.||Analysis from baseline to Week 24.||4.6|0.2|0.031
72399221|NCT05247229|144305266|SUPERIORITY||Slope|-0.42||||0.12|TWO_SIDED|95.0|-0.96|0.11|||Chi-squared|||Q6 Difference between pre- and post-program surveys from generalized estimating equation linear regressions accounting for clustering of longitudinal observations within person, adjusted associations and 95% confidence intervals.||0.11|-0.96|0.12
72399222|NCT05247229|144305266|SUPERIORITY||Slope|0.41||||0.21|TWO_SIDED|95.0|-0.23|1.05|||Chi-squared|||Q7 Difference between pre- and post-program surveys from generalized estimating equation linear regressions accounting for clustering of longitudinal observations within person, adjusted associations and 95% confidence intervals.||1.05|-0.23|0.21
72399223|NCT05247229|144305266|SUPERIORITY||Slope|0.07||||0.78|TWO_SIDED|95.0|-0.41|0.54|||Chi-squared|||Q15 Difference between pre- and post-program surveys from generalized estimating equation linear regressions accounting for clustering of longitudinal observations within person, adjusted associations and 95% confidence intervals.||0.54|-0.41|0.78
72399224|NCT05247229|144305267|SUPERIORITY||Slope|0.51||||0.01|TWO_SIDED|95.0|0.16|0.86|||Chi-squared|||Q1 Difference between pre- and post-program surveys from generalized estimating equation linear regressions accounting for clustering of longitudinal observations within person, adjusted associations and 95% confidence intervals.||0.86|0.16|0.01
72399225|NCT05247229|144305267|SUPERIORITY||Slope|0.09||||0.67|TWO_SIDED|95.0|-0.34|0.52|||Chi-squared|||Q2 Difference between pre- and post-program surveys from generalized estimating equation linear regressions accounting for clustering of longitudinal observations within person, adjusted associations and 95% confidence intervals.||0.52|-0.34|0.67
72399226|NCT05247229|144305267|SUPERIORITY||Slope|0.13||||0.35|TWO_SIDED|95.0|-0.15|0.41|||Chi-squared|||Q3 Difference between pre- and post-program surveys from generalized estimating equation linear regressions accounting for clustering of longitudinal observations within person, adjusted associations and 95% confidence intervals.||0.41|-0.15|0.35
72399227|NCT05247229|144305267|SUPERIORITY||Slope|0.09||||0.73|TWO_SIDED|95.0|-0.43|0.61|||Chi-squared|||Q4 Difference between pre- and post-program surveys from generalized estimating equation linear regressions accounting for clustering of longitudinal observations within person, adjusted associations and 95% confidence intervals.||0.61|-0.43|0.73
72399228|NCT05247229|144305267|SUPERIORITY||Slope|0.2||||0.23|TWO_SIDED|95.0|-0.13|0.52|||Chi-squared|||Q5 Difference between pre- and post-program surveys from generalized estimating equation linear regressions accounting for clustering of longitudinal observations within person, adjusted associations and 95% confidence intervals.||0.52|-0.13|0.23
72399229|NCT05247229|144305267|SUPERIORITY||Slope|0.71||||0|TWO_SIDED|95.0|0.27|1.15|||Chi-squared|||Q9 Difference between pre- and post-program surveys from generalized estimating equation linear regressions accounting for clustering of longitudinal observations within person, adjusted associations and 95% confidence intervals.||1.15|0.27|0.00
72399230|NCT05247229|144305267|SUPERIORITY||Slope|0.37||||0.05|TWO_SIDED|95.0|0.0|0.73|||Chi-squared|||Q10 Difference between pre- and post-program surveys from generalized estimating equation linear regressions accounting for clustering of longitudinal observations within person, adjusted associations and 95% confidence intervals.||0.73|0.00|0.05
72399231|NCT05247229|144305267|SUPERIORITY||Slope|0.37||||0.1|TWO_SIDED|95.0|-0.07|0.82|||Chi-squared|||Q11 Difference between pre- and post-program surveys from generalized estimating equation linear regressions accounting for clustering of longitudinal observations within person, adjusted associations and 95% confidence intervals.||0.82|-0.07|0.10
72399232|NCT05247229|144305267|SUPERIORITY||Slope|0.3||||0.32|TWO_SIDED|95.0|-0.3|0.91|||Chi-squared|||Q12 Difference between pre- and post-program surveys from generalized estimating equation linear regressions accounting for clustering of longitudinal observations within person, adjusted associations and 95% confidence intervals.||0.91|-0.30|0.32
72399233|NCT05247229|144305267|SUPERIORITY||Slope|0.22||||0.36|TWO_SIDED|95.0|-0.25|0.7|||Chi-squared|||Q13 Difference between pre- and post-program surveys from generalized estimating equation linear regressions accounting for clustering of longitudinal observations within person, adjusted associations and 95% confidence intervals.||0.70|-0.25|0.36
72399234|NCT05247229|144305267|SUPERIORITY||Slope|0.35||||0.11|TWO_SIDED|95.0|-0.07|0.78|||Chi-squared|||Q14 Difference between pre- and post-program surveys from generalized estimating equation linear regressions accounting for clustering of longitudinal observations within person, adjusted associations and 95% confidence intervals.||0.78|-0.07|0.11
72399235|NCT02472795|144305301|SUPERIORITY||Mean Difference (Final Values)|-0.17|STANDARD_ERROR_OF_MEAN|0.2||0.39|TWO_SIDED|95.0|-0.56|0.22|||ANCOVA|||||0.22|-0.56|0.39
72399236|NCT02472795|144305301|SUPERIORITY||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|0.2||0.02|TWO_SIDED|95.0|-0.91|0.09|||ANCOVA|||||0.09|-0.91|0.02
72399237|NCT02472795|144305301|SUPERIORITY||Mean Difference (Final Values)|-0.57|STANDARD_ERROR_OF_MEAN|0.19||0.004|TWO_SIDED|95.0|-0.95|-0.19|||ANCOVA|||||-0.19|-0.95|0.004
72399238|NCT02472795|144305301|SUPERIORITY||Mean Difference (Final Values)|-0.37|STANDARD_ERROR_OF_MEAN|0.19||0.06|TWO_SIDED|95.0|-0.75|0.02|||ANCOVA|||||0.02|-0.75|0.06
72399239|NCT02472795|144305303|SUPERIORITY||Mean Difference (Final Values)|-0.145|STANDARD_ERROR_OF_MEAN|0.134||0.2837|TWO_SIDED|95.0|-0.413|0.123|||ANCOVA|||||0.123|-0.413|0.2837
72399240|NCT02472795|144305303|SUPERIORITY||Mean Difference (Final Values)|-0.515|STANDARD_ERROR_OF_MEAN|0.14||0.0006|TWO_SIDED|95.0|-0.797|-0.234|||ANCOVA|||||-0.234|-0.797|0.0006
72399241|NCT02472795|144305303|SUPERIORITY||Mean Difference (Final Values)|-0.565|STANDARD_ERROR_OF_MEAN|0.13||0.0001|TWO_SIDED|95.0|-0.825|-0.305|||ANCOVA|||||-0.305|-0.825|0.0001
72399242|NCT02472795|144305303|SUPERIORITY||Mean Difference (Final Values)|-0.88|STANDARD_ERROR_OF_MEAN|0.147|<|0.0001|TWO_SIDED|95.0|-1.173|-0.586|||ANCOVA|||||-0.586|-1.173|<0.0001
72399243|NCT02472795|144305305|SUPERIORITY||Mean Difference (Final Values)|-13.214|STANDARD_ERROR_OF_MEAN|9.626||0.1755|TWO_SIDED|95.0|-32.513|6.085|||ANCOVA|||||6.085|-32.513|0.1755
72399244|NCT02472795|144305305|SUPERIORITY||Mean Difference (Final Values)|-39.311|STANDARD_ERROR_OF_MEAN|10.096||0.0003|TWO_SIDED|95.0|-59.552|-19.069|||ANCOVA|||||-19.069|-59.552|0.0003
72399245|NCT02472795|144305305|SUPERIORITY||Mean Difference (Final Values)|-47.278|STANDARD_ERROR_OF_MEAN|9.329|<|0.0001|TWO_SIDED|95.0|-65.981|-28.574|||ANCOVA|||||-28.574|-65.981|<0.0001
72399246|NCT02472795|144305305|SUPERIORITY||Mean Difference (Final Values)|-56.452|STANDARD_ERROR_OF_MEAN|10.541|<|0.0001|TWO_SIDED|95.0|-77.585|-35.32|||ANCOVA|||||-35.320|-77.585|<0.0001
72623209|NCT05796245|144777083|OTHER|Estimation|Risk Ratio (RR)|1.43|||||TWO_SIDED|95.0|0.38|5.34|||||Risk Ratio of Exposed/Reference, where Exposed is Infliximab-Pfizer Biosimilar and Reference is Remicade.|Comparative analysis set, IPTW weighted||5.34|0.38|
72399247|NCT00597012|144305385|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.4||||0.26|TWO_SIDED|95.0|-1.8|6.5|||ANCOVA|||"The primary analysis was implemented with an analysis of covariance with changes in the WOMAC physical-function score from baseline to 6 months as the dependent variable, treatment as the independent variable of interest, and study site as a covariate.~The primary analysis used a modified intention-to-treat approach in which patients who did not withdraw from the study were evaluated in the group to which they were randomly assigned."||6.5|-1.8|0.26
72399248|NCT00597012|144305386|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.9||||0.16|TWO_SIDED|95.0|-1.2|7.0|||ANCOVA|||||7.0|-1.2|0.16
72399249|NCT00597012|144305387|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|1.1||||0.68|TWO_SIDED|95.0|-4.4|6.6|||ANCOVA|||||6.6|-4.4|0.68
72507911|NCT00570739|144547504|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.5||||0.4063|TWO_SIDED|95.0|-8.4|3.4|||ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||Baseline to 16 weeks||3.4|-8.4|0.4063
72507912|NCT00570739|144547504|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.1||||0.4909|TWO_SIDED|95.0|-8.0|3.9|||ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||Baseline to 16 weeks (LOCF)||3.9|-8.0|0.4909
72507913|NCT00570739|144547505|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.303||||0.7606|TWO_SIDED|95.0|-2.259|1.653||P-Value is for the LS Mean Difference between treatment groups.|ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||Baseline to 4 weeks||1.653|-2.259|0.7606
72507914|NCT00570739|144547505|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.015||||0.1782|TWO_SIDED|95.0|-2.477|0.447||P-Value is for the LS Mean Difference between treatment groups.|ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||Baseline to 8 weeks||0.447|-2.477|0.1782
72507915|NCT00570739|144547505|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.504||||0.0332|TWO_SIDED|95.0|-2.887|-0.121||P-Value is for the LS Mean Difference between treatment groups.|ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||Baseline to 12 weeks||-0.121|-2.887|0.0332
72507916|NCT00570739|144547505|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.176||||0.861|TWO_SIDED|95.0|-1.805|2.158||P-Value is for the LS Mean Difference between treatment groups.|ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||Baseline to 16 weeks||2.158|-1.805|0.8610
72507917|NCT00570739|144547505|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.21||||0.8196|TWO_SIDED|95.0|-1.599|2.019||P-Value is for the LS Mean Difference between treatment groups.|ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||Baseline to 16 weeks (LOCF)||2.019|-1.599|0.8196
72507918|NCT00570739|144547506|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.153||||0.1078|TWO_SIDED|95.0|-0.34|0.034||P-Value is for the LS Mean Difference between treatment groups.|ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 weeks||0.034|-0.340|0.1078
72475943|NCT00581555|144477718|SUPERIORITY_OR_OTHER|||||||0.1196||95.0||||P-values were not adjusted for multiplicity and the priori threshold for statistical significance was 0.05.|Pearson chi-square or Fisher exact test|Treatment groups and visits were fixed factors with a logit link, a binomial distribution and an auto-regressive correlation structure.||Analysis from baseline to Week 24.||||0.1196
72475944|NCT03828747|144477719|SUPERIORITY||Least Squares Mean Difference|-2.89|STANDARD_ERROR_OF_MEAN|0.849||0.0008|TWO_SIDED|95.0|-4.56|-1.21|||Mixed Models Analysis|||Change from Baseline at Week 49||-1.21|-4.56|0.0008
72475945|NCT03828747|144477719|SUPERIORITY||Least Squares Mean Difference|-2.75|STANDARD_ERROR_OF_MEAN|1.287||0.0351|TWO_SIDED|95.0|-5.31|-0.2|||Mixed Models Analysis|||Change from Baseline at Week 61||-0.20|-5.31|0.0351
72475946|NCT03828747|144477720|SUPERIORITY||Least Squares Mean Difference|-0.83|STANDARD_ERROR_OF_MEAN|1.295||0.5207||95.0|-3.39|1.72|||Mixed Models Analysis|||Change from Baseline at Week 49||1.72|-3.39|0.5207
72507919|NCT00570739|144547506|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.141||||0.1146|TWO_SIDED|95.0|-0.317|0.035||P-Value is for the LS Mean Difference between treatment groups.|ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||Baseline to 16 weeks (LOCF)||0.035|-0.317|0.1146
72507920|NCT00570739|144547507|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.9933|TWO_SIDED|95.0|-9.3|9.4||P-Value is for the LS Mean Difference between treatment groups.|ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 weeks||9.4|-9.3|0.9933
72507921|NCT00570739|144547507|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.1||||0.8203|TWO_SIDED|95.0|-10.5|8.3||P-Value is for the LS Mean Difference between treatment groups.|ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 weeks LOCF||8.3|-10.5|0.8203
72507922|NCT00570739|144547508|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.0||||0.195|TWO_SIDED|95.0|-17.5|3.6||P-Value is for the LS Mean Difference between treatment groups.|ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||Baseline to 16 weeks||3.6|-17.5|0.1950
72507923|NCT00570739|144547508|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.7||||0.1583|TWO_SIDED|95.0|-18.3|3.0||P-Value is for the LS Mean Difference between treatment groups.|ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||Baseline to 16 Weeks LOCF||3.0|-18.3|0.1583
72623210|NCT05796245|144777083|OTHER|Estimation|Risk Difference (RD)|0.04|||||TWO_SIDED|95.0|-0.2|0.11|||||Risk Difference (Exposed-Reference), where Exposed is Infliximab-Pfizer Biosimilar and Reference is Remicade.|Comparative analysis set, IPTW weighted||0.11|-0.20|
72475947|NCT03828747|144477720|SUPERIORITY||Least Squares Mean Difference|-1.72|STANDARD_ERROR_OF_MEAN|1.911||0.3704||95.0|-5.5|2.07|||Mixed Models Analysis|||Change from Baseline at Week 61||2.07|-5.50|0.3704
72623211|NCT05796245|144777083|OTHER|Estimation|Cox Proportional Hazard|1.63|||||TWO_SIDED|95.0|0.54|4.9|||||Hazard Ratio of Exposed/Reference, where Exposed is Infliximab-Pfizer Biosimilar and Reference is Remicade.|Comparative matched analysis set||4.90|0.54|
72623212|NCT05796245|144777083|OTHER|Estimation|Risk Ratio (RR)|1.71|||||TWO_SIDED|95.0|0.55|5.26|||||Risk Ratio of Exposed/Reference, where Exposed is Infliximab-Pfizer Biosimilar and Reference is Remicade.|Comparative matched analysis set||5.26|0.55|
72623213|NCT05796245|144777083|OTHER|Estimation|Risk Difference (RD)|0.09|||||TWO_SIDED|95.0|-0.1|0.39|||||Risk Difference (Exposed-Reference), where Exposed is Infliximab-Pfizer Biosimilar and Reference is Remicade.|Comparative matched analysis set||0.39|-0.10|
72475948|NCT03828747|144477721|SUPERIORITY||Least Squares Mean Difference|0.26|STANDARD_ERROR_OF_MEAN|0.282||0.3501||95.0|-0.29|0.82|||Mixed Models Analysis|||Change from Baseline at Week 49||0.82|-0.29|0.3501
72475949|NCT03828747|144477721|SUPERIORITY||Least Squares Mean Difference|0.17|STANDARD_ERROR_OF_MEAN|0.525||0.7431|TWO_SIDED|95.0|-0.87|1.22|||Mixed Models Analysis|||Change from Baseline at Week 61||1.22|-0.87|0.7431
72475950|NCT03828747|144477722|SUPERIORITY||Least Squares Mean Difference|0.27|STANDARD_ERROR_OF_MEAN|0.429||0.5366||95.0|-0.58|1.11|||Mixed Models Analysis|||Change from Baseline at Week 49||1.11|-0.58|0.5366
72623214|NCT05796245|144777083|OTHER|Estimation|Cox Proportional Hazard|2.44|||||TWO_SIDED|95.0|1.05|5.67|||||Crude Hazard Ratio of Exposed/Reference, where Exposed is Infliximab-Pfizer Biosimilar and Reference is Remicade.|Comparative analysis set||5.67|1.05|
72475951|NCT03828747|144477722|SUPERIORITY||Least Squares Mean Difference|1.08|STANDARD_ERROR_OF_MEAN|0.618||0.0851||95.0|-0.15|2.3|||Mixed Models Analysis|||Change from Baseline at Week 61||2.30|-0.15|0.0851
72475952|NCT00355199|144477805|SUPERIORITY||Hazard Ratio (HR)|0.99|||<|0.05|TWO_SIDED|95.0|0.66|1.48|||Regression, Cox||HR refers to R-HDS (R-CHOP is the reference level)|||1.48|0.66|<0.05
72475953|NCT00355199|144477807|SUPERIORITY||Hazard Ratio (HR)|0.6|||<|0.05|TWO_SIDED|95.0|0.29|1.21|||Regression, Cox||HR refers to R-HDS (R-CHOP is the reference level)|||1.21|0.29|<0.05
72475954|NCT00355199|144477808|SUPERIORITY||Hazard Ratio (HR)|0.93|||<|0.05|TWO_SIDED|95.0|0.57|1.52|||Regression, Cox||HR refers to R-HDS (R-CHOP is the reference level)|||1.52|0.57|<0.05
72475955|NCT02503852|144477812|SUPERIORITY|||||||0.032|||||||ANCOVA|||||||0.032
72475956|NCT02503852|144477812|OTHER|||||||0.0318||||||P value cited is the difference in non-vellus hair count between the low-dose ADRC NW3 group and the no-fat saline control at week 24|ANCOVA|||Non-vellus hair count in the low-dose ADRC group in the NW3 subgroup beginning at Week 6 (mean change from baseline persisting through weeks 12 , 24, and 52.||||0.0318
72623215|NCT05796245|144777083|OTHER|Estimation|Risk Ratio (RR)|2.47|||||TWO_SIDED|95.0|1.02|5.99|||||Crude Risk Ratio of Exposed/Reference, where Exposed is Infliximab-Pfizer Biosimilar and Reference is Remicade.|Comparative analysis set||5.99|1.02|
72475957|NCT03231800|144477814|SUPERIORITY||Mean Difference (Final Values)|-5.24|STANDARD_ERROR_OF_MEAN|1.059|<|0.001|TWO_SIDED|95.0|-7.351|-3.137|||ANCOVA|||Least squares means, SEs, 95% CIs, and p-values were generated using an ANCOVA model, with treatment (dasotraline/placebo), mean SKAMP-CS at baseline, and site as fixed effects.||-3.137|-7.351|<0.001
72475958|NCT03231800|144477817|SUPERIORITY||Mean Difference (Final Values)|13.86|STANDARD_ERROR_OF_MEAN|5.612||0.016|TWO_SIDED|95.0|2.694|25.017|||ANCOVA|||||25.017|2.694|0.016
72475959|NCT03231800|144477818|SUPERIORITY||Mean Difference (Final Values)|12.06|STANDARD_ERROR_OF_MEAN|5.508||0.031|TWO_SIDED|95.0|1.105|23.017|||ANCOVA|||||23.017|1.105|0.031
72475960|NCT01670760|144477838|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.69||||0.69|TWO_SIDED||||||ANOVA|||||||0.69
72475961|NCT00741390|144477851|SUPERIORITY_OR_OTHER||Percentage|99.59||||||95.0|98.09|99.59||||||||99.59|98.09|
72475962|NCT00741390|144477851|SUPERIORITY_OR_OTHER||Percentage|100.0||||||95.0|98.79|100.0||||||||100|98.79|
72475963|NCT00741390|144477851|SUPERIORITY_OR_OTHER||Percentage|100.0||||||95.0|97.61|100.0||||||||100|97.61|
72475964|NCT00741390|144477851|SUPERIORITY_OR_OTHER||Percentage|100.0||||||95.0|95.36|100.0||||||||100|95.36|
72507924|NCT00570739|144547509|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.1||||0.3663|TWO_SIDED|95.0|-16.1|6.0||P-Value is for the LS Mean Difference between treatment groups.|ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||Baseline to 16 Weeks||6.0|-16.1|0.3663
72475965|NCT00741390|144477851|SUPERIORITY_OR_OTHER||Percentage|100.0||||||95.0|95.13|100.0||||||||100|95.13|
72475966|NCT00741390|144477852|SUPERIORITY_OR_OTHER||Mean Difference (Net)|10.84|||<|0.001||95.0|6.8|10.84|||ANOVA|A general linear model with subject as a random effect and order within a pair as a fixed effect was fit to each study group.||||10.84|6.80|<0.001
72475967|NCT00741390|144477852|SUPERIORITY_OR_OTHER||Mean Difference (Net)|8.55||||0.003||95.0|3.63|8.55|||ANOVA|A general linear model with subject as a random effect and order within a pair as a fixed effect was fit to each study group.||||8.55|3.63|0.003
72475968|NCT00741390|144477852|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.23||||0.46||95.0|-3.57|0.23|||ANOVA|A general linear model with subject as a random effect and order within a pair as a fixed effect was fit to each study group.||||0.23|-3.57|0.460
72475969|NCT00741390|144477853|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.9||||0.017||95.0|1.14|4.9|||ANOVA|A general linear model with subject as a random effect and order within a pair as a fixed effect was fit to each study group.||||4.90|1.14|0.017
72475970|NCT00741390|144477854|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||Fisher Exact|One proportion two-sided test; p=50%||Analysis consisted of a one proportion test for the 1st device in the lancing pair being preferred, out of the total number of times that a preference was stated. Note: lancing pairs in which no preference was stated or where data were missing were excluded from analysis. The null hypothesis for the one proportion test was that the 1st device in the lancing pair was preferred 50% of the times.||||0.001
72475971|NCT00741390|144477854|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||Fisher Exact|One proportion two-sided test; p=50%||Analysis consisted of a one proportion test for the 1st device in the lancing pair being preferred, out of the total number of times that a preference was stated. Note: lancing pairs in which no preference was stated or where data were missing were excluded from analysis. The null hypothesis for the one proportion test was that the 1st device in the lancing pair was preferred 50% of the times.||||0.002
72507925|NCT00570739|144547509|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.6||||0.2524|TWO_SIDED|95.0|-17.9|4.7||P-Value is for the LS Mean Difference between treatment groups.|ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||Baseline to 16 Weeks LOCF||4.7|-17.9|0.2524
72507926|NCT00570739|144547510|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.051||||0.8158|TWO_SIDED|95.0|-7.828|9.929||P-Value is for the LS Mean Difference between treatment groups.|ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||Baseline to 16 Weeks||9.929|-7.828|0.8158
72507927|NCT00570739|144547510|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.565||||0.7433|TWO_SIDED|95.0|-10.966|7.836||P-Value is for the LS Mean Difference between treatment groups.|ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||Baseline to 16 Weeks LOCF||7.836|-10.966|0.7433
72507928|NCT00570739|144547511|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.215||||0.5161|TWO_SIDED|95.0|-0.437|0.867||P-Value is for the LS Mean Difference between treatment groups.|ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||Baseline to 16 Weeks||0.867|-0.437|0.5161
72623216|NCT05796245|144777083|OTHER|Estimation|Risk Difference (RD)|0.13|||||TWO_SIDED|95.0|-0.06|0.32|||||Crude Risk Difference (Exposed-Reference), where Exposed is Infliximab-Pfizer Biosimilar and Reference is Remicade.|Comparative analysis set||0.32|-0.06|
72507929|NCT00570739|144547511|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.07||||0.8319|TWO_SIDED|95.0|-0.581|0.722||P-Value is for the LS Mean Difference between treatment groups.|ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||Baseline to 16 Weeks LOCF||0.722|-0.581|0.8319
72507930|NCT00570739|144547512|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-18.19|||<|0.0001|TWO_SIDED|95.0|-22.61|-13.76|||ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||Baseline to 8 Weeks||-13.76|-22.61|<0.0001
72507931|NCT00570739|144547512|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.08|||<|0.0001|TWO_SIDED|95.0|-22.09|-12.08|||ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||Baseline to 16 Weeks||-12.08|-22.09|<0.0001
72507932|NCT00570739|144547512|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.33|||<|0.0001|TWO_SIDED|95.0|-20.96|-11.69|||ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||Baseline to 16 Weeks LOCF||-11.69|-20.96|<0.0001
72507933|NCT00570739|144547513|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.4|||<|0.0001|TWO_SIDED|95.0|-15.99|-8.81|||ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||Baseline to 8 Weeks||-8.81|-15.99|<0.0001
72507934|NCT00570739|144547513|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.28|||<|0.0001|TWO_SIDED|95.0|-13.23|-5.34|||ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||Baseline to 16 Weeks||-5.34|-13.23|<0.0001
72507935|NCT00570739|144547513|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.33|||<|0.0001|TWO_SIDED|95.0|-11.98|-4.67|||ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||Baseline to 16 Week LOCF||-4.67|-11.98|<0.0001
72507936|NCT00570739|144547514|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|2.63||||0.2026|TWO_SIDED|95.0|-1.43|6.7|||ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||Baseline to 8 Weeks||6.70|-1.43|0.2026
72507937|NCT00570739|144547514|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.32||||0.4506|TWO_SIDED|95.0|-2.12|4.75|||ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||Baseline to 16 Weeks||4.75|-2.12|0.4506
72507938|NCT00570739|144547514|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.81||||0.2609|TWO_SIDED|95.0|-1.35|4.97|||ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||Baseline to 16 Weeks LOCF||4.97|-1.35|0.2609
72507939|NCT00570739|144547515|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.81|||<|0.0001|TWO_SIDED|95.0|-11.53|-6.08|||ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||Baseline to 8 Weeks||-6.08|-11.53|<0.0001
72507940|NCT00570739|144547515|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.94|||<|0.0001|TWO_SIDED|95.0|-10.23|-3.66|||ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||Baseline to 16 Weeks||-3.66|-10.23|<0.0001
72507941|NCT00570739|144547515|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.09||||0.0001|TWO_SIDED|95.0|-9.14|-3.05|||ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||Baseline to 16 Weeks LOCF||-3.05|-9.14|0.0001
72507942|NCT00570739|144547516|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.05||||0.0171|TWO_SIDED|95.0|-0.33|13.99||The P-Value was from the non-parametric ANCOVA stratified by country.|ANCOVA|The median difference was calculated using Hodges-Lehmann point estimate and corresponding 95% CI was constructed using the method of Moses.||Baseline to 8 weeks||13.99|-0.33|0.0171
72507943|NCT00570739|144547516|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|17.71|||<|0.0001|TWO_SIDED|95.0|9.66|25.54||The P-Value was from the non-parametric ANCOVA stratified by country.|ANCOVA|The median difference was calculated using Hodges-Lehmann point estimate and corresponding 95% CI was constructed using the method of Moses.||Baseline to 16 Weeks||25.54|9.66|<0.0001
72507944|NCT00570739|144547516|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|18.62|||<|0.0001|TWO_SIDED|95.0|11.18|25.74||The P-Value was from the non-parametric ANCOVA stratified by country.|ANCOVA|The median difference was calculated using Hodges-Lehmann point estimate and corresponding 95% CI was constructed using the method of Moses.||Baseline to 16 Weeks LOCF||25.74|11.18|<0.0001
72623217|NCT05796245|144777084|OTHER|Estimation|Risk Difference (RD)|0.0|||||TWO_SIDED|95.0|-0.01|0.0|||||Crude Risk Difference (Exposed-Reference), where Exposed is Infliximab-Pfizer Biosimilar and Reference is Remicade.|Comparative analysis set Note: Hazard ratio, risk ratio, and risk difference for the Comparative analysis set (IPTW weighted) and for the Comparative matched analysis set could not be calculated. Also, crude hazard ratio and crude risk ratio could not be calculated.||0.00|-0.01|
72507945|NCT00570739|144547517|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.81||||0.0496|TWO_SIDED|95.0|0.0|5.62|||ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||Baseline to 8 weeks||5.62|0.0|0.0496
72507946|NCT00570739|144547517|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.65||||0.0117|TWO_SIDED|95.0|0.82|6.47|||ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||Baseline to 16 Weeks||6.47|0.82|0.0117
72507947|NCT00570739|144547517|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.43||||0.0009|TWO_SIDED|95.0|1.83|7.03|||ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||Baseline to 16 Weeks LOCF||7.03|1.83|0.0009
72507948|NCT00570739|144547518|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.56|||<|0.0001|TWO_SIDED|95.0|-14.74|-8.38|||ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||Baseline to 8 Weeks||-8.38|-14.74|<0.0001
72507949|NCT00570739|144547518|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.53||||0.0001|TWO_SIDED|95.0|-13.14|-5.92|||ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||Baseline to 16 Weeks||-5.92|-13.14|0.0001
72623218|NCT05796245|144777085|OTHER|Estimation|Cox Proportional Hazard|1.22|||||TWO_SIDED|95.0|0.12|12.49|||||Hazard Ratio of Exposed/Reference, where Exposed is Infliximab-Pfizer Biosimilar and Reference is Remicade.|Comparative analysis set, IPTW weighted||12.49|0.12|
72623219|NCT05796245|144777085|OTHER|Estimation|Risk Ratio (RR)|1.41|||||TWO_SIDED|95.0|0.12|17.14|||||Risk Ratio of Exposed/Reference, where Exposed is Infliximab-Pfizer Biosimilar and Reference is Remicade.|Comparative analysis set, IPTW weighted||17.14|0.12|
72475972|NCT00741390|144477854|SUPERIORITY_OR_OTHER|||||||0.761||95.0|||||Fisher Exact|One proportion two-sided test; p=50%||Analysis consisted of a one proportion test for the 1st device in the lancing pair being preferred, out of the total number of times that a preference was stated. Note: lancing pairs in which no preference was stated or where data were missing were excluded from analysis. The null hypothesis for the one proportion test was that the 1st device in the lancing pair was preferred 50% of the times.||||0.761
72475973|NCT00741390|144477854|SUPERIORITY_OR_OTHER|||||||0.004||95.0|||||Fisher Exact|One proportion two-sided test; p=50%||Analysis consisted of a one proportion test for the 1st device in the lancing pair being preferred, out of the total number of times that a preference was stated. Note: lancing pairs in which no preference was stated or where data were missing were excluded from analysis. The null hypothesis for the one proportion test was that the 1st device in the lancing pair was preferred 50% of the times.||||0.004
72475974|NCT00620282|144477855|SUPERIORITY_OR_OTHER||Least squares mean|7.43||||0.0549||95.0|-0.164|15.025||2-sided significance level of 5%.|ANCOVA|||Change in Ach-mediated FBF from baseline to end of treatment at 12 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline FBF as a covariate.||15.025|-0.164|0.0549
72475975|NCT00620282|144477855|SUPERIORITY_OR_OTHER||Least squares mean|2.08||||0.5681||95.0|-5.215|9.375||2-sided significance level of 5%.|ANCOVA|||Change in Ach-mediated FBF from baseline to end of treatment at 12 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline FBF as a covariate.||9.375|-5.215|0.5681
72475976|NCT00620282|144477855|SUPERIORITY_OR_OTHER||Least squares mean|5.35||||0.1668||95.0|-2.323|13.024||2-sided significance level of 5%.|ANCOVA|||Change in Ach-mediated FBF from baseline to end of treatment at 12 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline FBF as a covariate.||13.024|-2.323|0.1668
72475977|NCT00620282|144477856|SUPERIORITY_OR_OTHER||Least squares mean|4.499||||0.2648||95.0|-3.535|12.534||2-sided significance level of 5%.|ANCOVA|||Change in SNP-mediated FBF from baseline to end of treatment at 12 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline FBF as a covariate.||12.534|-3.535|0.2648
72475978|NCT00620282|144477856|SUPERIORITY_OR_OTHER||Least squares mean|0.709||||0.8518||95.0|-6.904|8.322||2-sided significance level of 5%.|ANCOVA|||Change in SNP-mediated FBF from baseline to end of treatment at 12 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline FBF as a covariate.||8.322|-6.904|0.8518
72475979|NCT00620282|144477856|SUPERIORITY_OR_OTHER||Least squares mean|3.79||||0.3435||95.0|-4.194|11.774||2-sided significance level of 5%.|ANCOVA|||Change in SNP-mediated FBF from baseline to end of treatment at 12 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline FBF as a covariate.||11.774|-4.194|0.3435
72475980|NCT00620282|144477857|SUPERIORITY_OR_OTHER||Least squares mean|-0.536||||0.0023||95.0|-0.868|-0.203||2-sided significance level of 5%.|ANCOVA|||Change in HbA1c from baseline to end of treatment at 12 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline HbA1c as a covariate.||-0.203|-0.868|0.0023
72507950|NCT00570739|144547518|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.97|||<|0.0001|TWO_SIDED|95.0|-11.35|-4.59|||ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||Baseline to 16 Weeks LOCF||-4.59|-11.35|<0.0001
72475981|NCT00620282|144477857|SUPERIORITY_OR_OTHER||Least squares mean|-0.077||||0.6207||95.0|-0.391|0.236||2-sided significance level of 5%.|ANCOVA|||Change in HbA1c from baseline to end of treatment at 12 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline HbA1c as a covariate.||0.236|-0.391|0.6207
72475982|NCT00620282|144477857|SUPERIORITY_OR_OTHER||Least squares mean|-0.458||||0.0098||95.0|-0.8|-0.116||2-sided significance level of 5%.|ANCOVA|||Change in HbA1c from baseline to end of treatment at 12 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline HbA1c as a covariate.||-0.116|-0.8|0.0098
72507951|NCT00570739|144547519|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.57||||0.0003|TWO_SIDED|95.0|5.76|19.38|||ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||Baseline to 8 Weeks||19.38|5.76|0.0003
72475983|NCT00620282|144477858|SUPERIORITY_OR_OTHER||Least squares mean|-35.605||||||95.0|-46.797|-24.413||2-sided significance level of 5%.|ANCOVA|||Change in FPG from baseline to end of treatment at 12 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline FPG as a covariate.||-24.413|-46.797|
72475984|NCT00620282|144477858|SUPERIORITY_OR_OTHER||Least squares mean|-9.653||||0.0677||95.0|-20.041|0.736||2-sided significance level of 5%.|ANCOVA|||Change in FPG from baseline to end of treatment at 12 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline FPG as a covariate.||0.736|-20.041|0.0677
72475985|NCT00620282|144477858|SUPERIORITY_OR_OTHER||Least squares mean|-25.952||||||95.0|-37.429|-14.475||2-sided significance level of 5%.|ANCOVA|||Change in FPG from baseline to end of treatment at 12 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline FPG as a covariate.||-14.475|-37.429|
72475986|NCT00620282|144477859|SUPERIORITY_OR_OTHER||Least squares mean|-11.871||||0.4121||95.0|-40.943|17.201||2-sided significance level of 5%.|ANCOVA|||Change in PPG from baseline to end of treatment at 12 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline PPG as a covariate.||17.201|-40.943|0.4121
72475987|NCT00620282|144477859|SUPERIORITY_OR_OTHER||Least squares mean|3.815||||0.7622||95.0|-21.618|29.247||2-sided significance level of 5%|ANCOVA|||Change in PPG from baseline to end of treatment at 12 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline PPG as a covariate.||29.247|-21.618|0.7622
72475988|NCT00620282|144477859|SUPERIORITY_OR_OTHER||Least squares mean|-15.686||||0.2651||95.0|-43.838|12.466||2-sided significance level of 5%.|ANCOVA|||Change in PPG from baseline to end of treatment at 12 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline PPG as a covariate.||12.466|-43.838|0.2651
72475989|NCT00620282|144477860|SUPERIORITY_OR_OTHER||Least squares mean|-1.528||||0.0268||95.0|-2.873|-0.184||2-sided significance level of 5%.|ANCOVA|||Change in body weight from baseline to end of treatment at 12 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline body weight as a covariate.||-0.184|-2.873|0.0268
72475990|NCT00620282|144477860|SUPERIORITY_OR_OTHER||Least squares mean|-2.859||||||95.0|-4.139|-1.579||2-sided significance level of 5%.|ANCOVA|||Change in body weight from baseline to end of treatment at 12 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline body weight as a covariate.||-1.579|-4.139|
72507952|NCT00570739|144547519|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.52||||0.0003|TWO_SIDED|95.0|6.64|22.4|||ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||Baseline to 16 Weeks||22.40|6.64|0.0003
72475991|NCT00620282|144477860|SUPERIORITY_OR_OTHER||Least squares mean|1.331||||0.0486||95.0|0.009|2.653||2-sided significance level of 5%.|ANCOVA|||Change in body weight from baseline to end of treatment at 12 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline body weight as a covariate.||2.653|0.0090|0.0486
72475992|NCT00620282|144477861|SUPERIORITY_OR_OTHER||Least squares mean|-2.237||||0.7736||95.0|-17.829|13.354||2-sided significance level of 5%.|ANCOVA|||Change in TC from baseline to end of treatment at 12 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline TC as a covariate.||13.354|-17.829|0.7736
72475993|NCT00620282|144477861|SUPERIORITY_OR_OTHER||Least squares mean|1.912||||0.7993||95.0|-13.168|16.991||2-sided significance level of 5%.|ANCOVA|||Change in TC from baseline to end of treatment at 12 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline TC as a covariate.||16.991|-13.168|0.7993
72475994|NCT00620282|144477861|SUPERIORITY_OR_OTHER||Least squares mean|-4.149||||0.5903||95.0|-19.582|11.284||2-sided significance level of 5%.|ANCOVA|||Change in TC from baseline to end of treatment at 12 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline TC as a covariate.||11.284|-19.582|0.5903
72475995|NCT00620282|144477862|SUPERIORITY_OR_OTHER||Least squares mean|3.702||||0.5583||95.0|-8.96|16.365||2-sided significance level of 5%.|ANCOVA|||Change in LDL-C from baseline to end of treatment at 12 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline LDL-C as a covariate.||16.365|-8.96|0.5583
72475996|NCT00620282|144477862|SUPERIORITY_OR_OTHER||Least squares mean|2.773||||0.6517||95.0|-9.537|15.082||2-sided significance level of 5%.|ANCOVA|||Change in LDL-C from baseline to end of treatment at 12 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline LDL-C as a covariate.||15.082|-9.537|0.6517
72475997|NCT00620282|144477862|SUPERIORITY_OR_OTHER||Least squares mean|0.929||||0.8822||95.0|-11.646|13.505||2-sided significance level of 5%.|ANCOVA|||Change in LDL-C from baseline to end of treatment at 12 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline LDL-C as a covariate.||13.505|-11.646|0.8822
72475998|NCT00620282|144477863|SUPERIORITY_OR_OTHER||Least squares mean|-0.169||||0.9131||95.0|-3.273|2.935||2-sided significance level of 5%.|ANCOVA|||Change in HDL-C from baseline to end of treatment at 12 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline HDL-C as a covariate.||2.935|-3.273|0.9131
72475999|NCT00620282|144477863|SUPERIORITY_OR_OTHER||Least squares mean|-0.723||||0.6362||95.0|-3.785|2.339||2-sided significance level of 5%.|ANCOVA|||Change in HDL-C from baseline to end of treatment at 12 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline HDL-C as a covariate.||2.339|-3.785|0.6362
72476000|NCT00620282|144477863|SUPERIORITY_OR_OTHER||Least squares mean|0.554||||0.7283||95.0|-2.643|3.751||2-sided significance level of 5%.|ANCOVA|||Change in HDL-C from baseline to end of treatment at 12 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline HDL-C as a covariate.||3.751|-2.643|0.7283
72476001|NCT00620282|144477864|SUPERIORITY_OR_OTHER||Least squares mean|-36.709||||0.0694||95.0|-76.467|3.048||2-sided significance level of 5%.|ANCOVA|||Change in TG from baseline to end of treatment at 12 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline TG as a covariate.||3.048|-76.467|0.0694
72476002|NCT00620282|144477864|SUPERIORITY_OR_OTHER||Least squares mean|-3.786||||0.844||95.0|-42.373|34.801||2-sided significance level of 5%.|ANCOVA|||Change in TG from baseline to end of treatment at 12 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline TG as a covariate.||34.801|-42.373|0.844
72476003|NCT00620282|144477864|SUPERIORITY_OR_OTHER||Least squares mean|-32.923||||0.0994||95.0|-72.353|6.507||2-sided significance level of 5%.|ANCOVA|||Change in TG from baseline to end of treatment at 12 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline TG as a covariate.||6.507|-72.353|0.0994
72476004|NCT00620282|144477865|SUPERIORITY_OR_OTHER||Least squares mean|-0.42||||0.2282||95.0|-1.118|0.278||2-sided significance level of 5%.|ANCOVA|||Change in TNF-alpha from baseline to end of treatment at 12 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline TNF-alpha as a covariate.||0.278|-1.118|0.2282
72476005|NCT00620282|144477865|SUPERIORITY_OR_OTHER||Least squares mean|-0.018||||0.9569||95.0|-0.697|0.661||2-sided significance level of 5%.|ANCOVA|||Change in TNF-alpha from baseline to end of treatment at 12 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline TNF-alpha as a covariate.||0.661|-0.697|0.9569
72476006|NCT00620282|144477865|SUPERIORITY_OR_OTHER||Least squares mean|-0.402||||0.2465||95.0|-1.097|0.293||2-sided significance level of 5%.|ANCOVA|||Change in TNF-alpha from baseline to end of treatment at 12 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline TNF-alpha as a covariate.||0.293|-1.097|0.2465
72476007|NCT02285153|144477878|SUPERIORITY||Cox Proportional Hazard|0.434|STANDARD_ERROR_OF_MEAN|1.225||0.57|TWO_SIDED|95.0|0.039|4.792||Due to the low number of participants, the results of the statistical tests must be interpreted with caution!|Chi-squared|||||4.792|0.039|0.57
72476008|NCT02285153|144477879|SUPERIORITY|||||||0.057|||||||Chi-squared|||||||0.057
72476009|NCT02285153|144477880|SUPERIORITY|||||||1|||||||Chi-squared|||||||1
72476010|NCT02285153|144477881|SUPERIORITY|||||||0.467|||||||Chi-squared|||||||0.467
72476011|NCT01472549|144477883|SUPERIORITY||Risk Ratio (RR)|0.55||||0.02|TWO_SIDED|95.0|0.34|0.9|||Chi-squared|||||0.90|0.34|0.02
72476012|NCT01472549|144477884|SUPERIORITY|||||||0.24|||||||Wilcoxon (Mann-Whitney)|||||||0.24
72476013|NCT01472549|144477885|SUPERIORITY||Risk Ratio (RR)|0.76||||0.37|TWO_SIDED|95.0|0.43|1.37|||Chi-squared|||||1.37|0.43|0.37
72476014|NCT01472549|144477886|SUPERIORITY||Risk Ratio (RR)|0.73||||0.49|TWO_SIDED|95.0|0.3|1.8|||Chi-squared|||||1.80|0.30|0.49
72476015|NCT01472549|144477887|SUPERIORITY|||||||0.08|||||||Fisher Exact|||||||0.08
72476016|NCT01472549|144477888|SUPERIORITY||Risk Ratio (RR)|2.02||||0.56|TWO_SIDED|95.0|0.18|22.11|||Fisher Exact|||||22.11|0.18|0.56
72476017|NCT01489891|144477891|NON_INFERIORITY_OR_EQUIVALENCE|Beta 0.1; Alpha 0.05|Median Difference (Final Values)|30.6|STANDARD_DEVIATION|42.1|<|0.05|TWO_SIDED|95.0|||||t-test, 2 sided|||||||<0.05
72476018|NCT01056718|144477922|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||t-test, 2 sided|||Nebivolol treatment group refers to 50 patients that completed 10 weeks of open label nebivolol treatment. Results were compared using paired T-tests in a pre - post study design before and after 10 weeks of treatment. Each subject served as his/her own control.||||<0.05
72476019|NCT01056718|144477923|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||t-test, 2 sided|||Nebivolol treatment group refers to 50 patients that completed 10 weeks of open label nebivolol treatment. Results were compared using paired T-tests in a pre - post study design before and after 10 weeks of his/her treatment. Each subject served as own control.||||<0.05
72476020|NCT01056718|144477924|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||t-test, 2 sided|||Nebivolol treatment group refers to 50 patients that completed 10 weeks of open label nebivolol treatment. Results were compared using paired T-tests in a pre - post study design before and after 10 weeks of his/her treatment. Each subject served as own control.||||<0.05
72476021|NCT01056718|144477925|SUPERIORITY_OR_OTHER||||||=|0.078|TWO_SIDED||||||t-test, 2 sided|||Nebivolol treatment group refers to 50 patients that completed 10 weeks of open label nebivolol treatment. Results were compared using paired T-tests in a pre - post study design before and after 10 weeks of his/her treatment. Each subject served as own control.||||=.078
72476022|NCT01056718|144477926|SUPERIORITY_OR_OTHER||||||=|0.186|TWO_SIDED||||||t-test, 2 sided|||Nebivolol treatment group refers to 50 patients that completed 10 weeks of open label nebivolol treatment. Results were compared using paired T-tests in a pre - post study design before and after 10 weeks of his/her treatment. Each subject served as own control.||||=.186
72476023|NCT01056718|144477927|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||t-test, 2 sided|||Nebivolol treatment group refers to 50 patients that completed 10 weeks of open label nebivolol treatment. Results were compared using paired T-tests in a pre - post study design before and after 10 weeks of his/her treatment. Each subject served as own control.||||<0.05
72476024|NCT01056718|144477928|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||t-test, 2 sided|||Nebivolol treatment group refers to 50 patients that completed 10 weeks of open label nebivolol treatment. Results were compared using paired T-tests in a pre - post study design before and after 10 weeks of his/her treatment. Each subject served as own control.||||<0.05
72476025|NCT01056718|144477929|SUPERIORITY_OR_OTHER||||||=|0.06|TWO_SIDED||||||t-test, 2 sided|||Nebivolol treatment group refers to 50 patients that completed 10 weeks of open label nebivolol treatment. Results were compared using paired T-tests in a pre - post study design before and after 10 weeks of his/her treatment. Each subject served as own control.||||=0.06
72476026|NCT01056718|144477930|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||t-test, 2 sided|||Nebivolol treatment group refers to 50 patients that completed 10 weeks of open label nebivolol treatment. Results were compared using paired T-tests in a pre - post study design before and after 10 weeks of his/her treatment. Each subject served as own control.||||<0.05
72476027|NCT01056718|144477931|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||t-test, 2 sided|||Nebivolol treatment group refers to 50 patients that completed 10 weeks of open label nebivolol treatment. Results were compared using paired T-tests in a pre - post study design before and after 10 weeks of his/her treatment. Each subject served as own control.||||<0.05
72476028|NCT01056718|144477932|SUPERIORITY_OR_OTHER||||||=|0.85|TWO_SIDED||||||t-test, 2 sided|||Nebivolol treatment group refers to 50 patients that completed 10 weeks of open label nebivolol treatment. Results were compared using paired T-tests in a pre - post study design before and after 10 weeks of his/her treatment. Each subject served as own control.||||=0.85
72476029|NCT01056718|144477933|SUPERIORITY_OR_OTHER||||||=|0.4|TWO_SIDED||||||t-test, 2 sided|||Nebivolol treatment group refers to 50 patients that completed 10 weeks of open label nebivolol treatment. Results were compared using paired T-tests in a pre - post study design before and after 10 weeks of his/her treatment. Each subject served as own control.||||=0.40
72476030|NCT01056718|144477934|SUPERIORITY_OR_OTHER||||||=|0.64|TWO_SIDED||||||t-test, 2 sided|||Nebivolol treatment group refers to 50 patients that completed 10 weeks of open label nebivolol treatment. Results were compared using paired T-tests in a pre - post study design before and after 10 weeks of his/her treatment. Each subject served as own control.||||=0.64
72476031|NCT01056718|144477935|SUPERIORITY_OR_OTHER||||||=|0.49|TWO_SIDED||||||t-test, 2 sided|||Nebivolol treatment group refers to 50 patients that completed 10 weeks of open label nebivolol treatment. Results were compared using paired T-tests in a pre - post study design before and after 10 weeks of his/her treatment. Each subject served as own control.||||=0.49
72476032|NCT01056718|144477936|SUPERIORITY_OR_OTHER||||||=|0.47|TWO_SIDED||||||t-test, 2 sided|||Nebivolol treatment group refers to 50 patients that completed 10 weeks of open label nebivolol treatment. Results were compared using paired T-tests in a pre - post study design before and after 10 weeks of his/her treatment. Each subject served as own control.||||=0.47
72476033|NCT01056718|144477937|SUPERIORITY_OR_OTHER||||||=|0.55|TWO_SIDED||||||t-test, 2 sided|||Nebivolol treatment group refers to 50 patients that completed 10 weeks of open label nebivolol treatment. Results were compared using paired T-tests in a pre - post study design before and after 10 weeks of his/her treatment. Each subject served as own control.||||=0.55
72476034|NCT01056718|144477938|SUPERIORITY_OR_OTHER||||||=|0.64|TWO_SIDED||||||t-test, 2 sided|||Nebivolol treatment group refers to 50 patients that completed 10 weeks of open label nebivolol treatment. Results were compared using paired T-tests in a pre - post study design before and after 10 weeks of his/her treatment. Each subject served as own control.||||=0.64
72476035|NCT01056718|144477939|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||t-test, 2 sided|||Nebivolol treatment group refers to 50 patients that completed 10 weeks of open label nebivolol treatment. Results were compared using paired T-tests in a pre - post study design before and after 10 weeks of his/her treatment. Each subject served as own control.||||<0.05
72476036|NCT01056718|144477940|SUPERIORITY_OR_OTHER||||||=|0.526|TWO_SIDED||||||t-test, 2 sided|||Nebivolol treatment group refers to 50 patients that completed 10 weeks of open label nebivolol treatment. Results were compared using paired T-tests in a pre - post study design before and after 10 weeks of his/her treatment. Each subject served as own control.||||=.526
72476037|NCT01056718|144477941|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||t-test, 2 sided|||Nebivolol treatment group refers to 50 patients that completed 10 weeks of open label nebivolol treatment. Results were compared using paired T-tests in a pre - post study design before and after 10 weeks of his/her treatment. Each subject served as own control.||||<0.05
72476038|NCT01056718|144477942|SUPERIORITY_OR_OTHER||||||=|0.925|TWO_SIDED||||||t-test, 2 sided|||Nebivolol treatment group refers to 50 patients that completed 10 weeks of open label nebivolol treatment. Results were compared using paired T-tests in a pre - post study design before and after 10 weeks of his/her treatment. Each subject served as own control.||||=.925
72476039|NCT01056718|144477943|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||t-test, 2 sided|||Nebivolol treatment group refers to 50 patients that completed 10 weeks of open label nebivolol treatment. Results were compared using paired T-tests in a pre - post study design before and after 10 weeks of his/her treatment. Each subject served as own control.||||<0.05
72476040|NCT01056718|144477944|SUPERIORITY_OR_OTHER||||||=|0.458|TWO_SIDED||||||t-test, 2 sided|||Nebivolol treatment group refers to 50 patients that completed 10 weeks of open label nebivolol treatment. Results were compared using paired T-tests in a pre - post study design before and after 10 weeks of his/her treatment. Each subject served as own control.||||=.458
72623220|NCT05796245|144777085|OTHER|Estimation|Risk Difference (RD)|0.0|||||TWO_SIDED|95.0|-0.05|0.01|||||Risk Difference (Exposed-Reference), where Exposed is Infliximab-Pfizer Biosimilar and Reference is Remicade.|Comparative analysis set, IPTW weighted||0.01|-0.05|
72623221|NCT05796245|144777085|OTHER|Estimation|Cox Proportional Hazard|6.12|||||TWO_SIDED|95.0|0.81|45.94|||||Crude Hazard Ratio of Exposed/Reference, where Exposed is Infliximab-Pfizer Biosimilar and Reference is Remicade.|Comparative analysis set Note: Hazard ratio, risk ratio, and risk difference for the comparative matched analysis set could not be calculated.||45.94|0.81|
72623222|NCT05796245|144777085|OTHER|Estimation|Risk Ratio (RR)|7.07|||||TWO_SIDED|95.0|0.93|53.51|||||Crude Risk Ratio of Exposed/Reference, where Exposed is Infliximab-Pfizer Biosimilar and Reference is Remicade.|Comparative analysis set||53.51|0.93|
72623223|NCT05796245|144777085|OTHER|Estimation|Risk Difference (RD)|0.03|||||TWO_SIDED|95.0|-0.04|0.1|||||Crude Risk Difference (Exposed-Reference), where Exposed is Infliximab-Pfizer Biosimilar and Reference is Remicade.|Comparative analysis set||0.10|-0.04|
72476041|NCT01056718|144477945|SUPERIORITY_OR_OTHER||||||=|0.561|TWO_SIDED||||||t-test, 2 sided|||Nebivolol treatment group refers to 50 patients that completed 10 weeks of open label nebivolol treatment. Results were compared using paired T-tests in a pre - post study design before and after 10 weeks of his/her treatment. Each subject served as own control.||||=.561
72476042|NCT01056718|144477946|SUPERIORITY_OR_OTHER||||||=|0.734|TWO_SIDED||||||t-test, 2 sided|||Nebivolol treatment group refers to 50 patients that completed 10 weeks of open label nebivolol treatment. Results were compared using paired T-tests in a pre - post study design before and after 10 weeks of his/her treatment. Each subject served as own control.||||=.734
72476043|NCT01056718|144477947|SUPERIORITY_OR_OTHER||||||=|0.129|TWO_SIDED||||||t-test, 2 sided|||Nebivolol treatment group refers to 50 patients that completed 10 weeks of open label nebivolol treatment. Results were compared using paired T-tests in a pre - post study design before and after 10 weeks of his/her treatment. Each subject served as own control.||||=.129
72476044|NCT05086276|144477949|SUPERIORITY||Odds Ratio (OR)|1.4||||0.525|TWO_SIDED|95.0|0.51|3.73||P value for statistical significance is \<0.05|Chi-squared|||||3.73|0.51|0.525
72476045|NCT05086276|144477949|SUPERIORITY||Mean Difference (Final Values)|3.6||||0.525|TWO_SIDED|95.0|-7.52|14.71||P value for statistical significance is \<0.05|Chi-squared|||||14.71|-7.52|0.525
72476046|NCT05086276|144477950|SUPERIORITY||Least squares mean difference|0.02|STANDARD_ERROR_OF_MEAN|0.491||0.973|TWO_SIDED|95.0|-0.954|0.987||P value for statistical significance is \<0.05|Mixed Models Analysis|||||0.987|-0.954|0.973
72476047|NCT05086276|144477952|SUPERIORITY||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.1||0.16|TWO_SIDED|95.0|-0.06|0.34||P value for statistical significance is \<0.05|ANCOVA|||||0.34|-0.06|0.160
72476048|NCT05086276|144477953|SUPERIORITY||Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|0.1||0.027|TWO_SIDED|95.0|0.03|0.41||P value for statistical significance is \<0.05|ANCOVA|||||0.41|0.03|0.027
72476049|NCT00777088|144477954|NON_INFERIORITY|The cumulative rate of ipsilateral stroke or neurologic death is not ≥ 20% at 180-day clinical follow-up and the cumulative rate of ipsilateral stroke or neurovascular death is not ≥ 25% at 5-year clinical follow-up|||||<|0.001|||||||Bayesian|||||||<.001
72476050|NCT00777088|144477955|NON_INFERIORITY_OR_EQUIVALENCE|The rate of complete IA occlusion without major parent artery stenosis exceeds 50% with a posterior probability \>0.975.|||||<|0.001|||||||Bayesian|||||||<0.001
72476051|NCT03592745|144477963|EQUIVALENCE|Statistical analysis of the median absolute change in bicep peak sEMG amplitude from baseline to DC immediately following 3 weeks of training was measured in the active vs. sham tVNS conditions. Null hypothesis is that there is no difference in median absolute change in bicep peak sEMG amplitude between the active and sham tVNS conditions. A significance level of 0.05 was used (two-tailed).|U value|32.0||||0.002|TWO_SIDED|||||The Mann-Whitney Wilcoxon test was performed to compare median absolute change in bicep peak sEMG amplitude from baseline to 3 weeks (discharge) across two separate study conditions (active vs. sham tVNS).|Wilcoxon (Mann-Whitney)|||||||0.002
72507953|NCT00570739|144547519|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|15.08|||<|0.0001|TWO_SIDED|95.0|7.95|22.2|||ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||Baseline to 16 Weeks LOCF||22.20|7.95|<0.0001
72507954|NCT00570739|144547520|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.84||||0.0363|TWO_SIDED|95.0|0.44|13.24||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Total Very Low Density Lipoprotein (VLDL) Particles||13.24|0.44|0.0363
72507955|NCT00570739|144547520|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.39||||0.0347|TWO_SIDED|95.0|0.46|12.31||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Total Very Low Density Lipoprotein (VLDL) Particles||12.31|0.46|0.0347
72507956|NCT00570739|144547520|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.31||||0.0028|TWO_SIDED|95.0|0.8|3.81||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||VLDL Chylomicron Particles||3.81|0.80|0.0028
72507957|NCT00570739|144547520|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.34||||0.001|TWO_SIDED|95.0|0.96|3.73||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||VLDL Chylomicron Particles||3.73|0.96|0.0010
72507958|NCT00570739|144547520|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.13||||0.0006|TWO_SIDED|95.0|3.1|11.21||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Medium VLDL Particles||11.21|3.10|0.0006
72507959|NCT00570739|144547520|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.13||||0.0003|TWO_SIDED|95.0|3.35|10.91||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Medium VLDL Particles||10.91|3.35|0.0003
72507960|NCT00570739|144547520|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.88||||0.175|TWO_SIDED|95.0|-7.04|1.29||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Small VLDL Particles||1.29|-7.04|0.1750
72507961|NCT00570739|144547520|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.23||||0.1007|TWO_SIDED|95.0|-7.1|0.63||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Small VLDL Particles||0.63|-7.10|0.1007
72507962|NCT00570739|144547520|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-199.3|||<|0.0001|TWO_SIDED|95.0|-272.9|-125.8||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Total Low Density Lipoprotein (LDL) Particles||-125.8|-272.9|<0.0001
72507963|NCT00570739|144547520|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-186.1||||0.0001|TWO_SIDED|95.0|-255.9|-116.3||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Total Low Density Lipoprotein (LDL) Particles||-116.3|-255.9|0.0001
72507964|NCT00570739|144547520|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.7||||0.0466|TWO_SIDED|95.0|-23.3|-0.2||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Intermediate Density Lipoprotein Particles||-0.2|-23.3|0.0466
72507965|NCT00570739|144547520|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.7||||0.057|TWO_SIDED|95.0|-21.8|0.3||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Intermediate Density Lipoprotein Particles||0.3|-21.8|0.0570
72507966|NCT00570739|144547520|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-77.7||||0.0004|TWO_SIDED|95.0|-120.3|-35.0||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Large LDL Particles||-35.0|-120.3|0.0004
72507967|NCT00570739|144547520|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-69.3||||0.0007|TWO_SIDED|95.0|-109.2|-29.3||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Large LDL Particles||-29.3|-109.2|0.0007
72507968|NCT00570739|144547520|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-109.9||||0.0124|TWO_SIDED|95.0|-195.8|-23.9||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Small LDL Particles||-23.9|-195.8|0.0124
72566292|NCT02697773|144663258|SUPERIORITY||Least Square Mean Difference|-0.66|STANDARD_ERROR_OF_MEAN|0.21||0.002|TWO_SIDED|95.0|-1.08|-0.24|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain subscale and baseline diary average pain as covariate, and study site as a random effect.||-0.24|-1.08|0.0020
72566293|NCT02697773|144663258|SUPERIORITY||Least Square Mean Difference|-0.68|STANDARD_ERROR_OF_MEAN|0.21||0.0014|TWO_SIDED|95.0|-1.1|-0.26|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain subscale and baseline diary average pain as covariate, and study site as a random effect.||-0.26|-1.10|0.0014
72566294|NCT02697773|144663258|SUPERIORITY||Least Square Mean Difference|-0.88|STANDARD_ERROR_OF_MEAN|0.22|<|0.0001|TWO_SIDED|95.0|-1.31|-0.45|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain subscale and baseline diary average pain as covariate, and study site as a random effect.||-0.45|-1.31|<.0001
72566295|NCT02697773|144663258|SUPERIORITY||Least Square Mean Difference|-0.87|STANDARD_ERROR_OF_MEAN|0.22|<|0.0001|TWO_SIDED|95.0|-1.3|-0.44|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain subscale and baseline diary average pain as covariate, and study site as a random effect.||-0.44|-1.30|<.0001
72507969|NCT00570739|144547520|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-106.8||||0.0098|TWO_SIDED|95.0|-187.6|-26.0||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Small LDL Particles||-26.0|-187.6|0.0098
72507970|NCT00570739|144547520|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.2||||0.102|TWO_SIDED|95.0|-35.6|3.2||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Medium Small LDL Particles||3.2|-35.6|0.1020
72566296|NCT02697773|144663258|SUPERIORITY||Least Square Mean Difference|-0.59|STANDARD_ERROR_OF_MEAN|0.23||0.0085|TWO_SIDED|95.0|-1.03|-0.15|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain subscale and baseline diary average pain as covariate, and study site as a random effect.||-0.15|-1.03|0.0085
72566297|NCT02697773|144663258|SUPERIORITY||Least Square Mean Difference|-0.41|STANDARD_ERROR_OF_MEAN|0.22||0.0657|TWO_SIDED|95.0|-0.85|0.03|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain subscale and baseline diary average pain as covariate, and study site as a random effect.||0.03|-0.85|0.0657
72507971|NCT00570739|144547520|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.4||||0.0997|TWO_SIDED|95.0|-33.8|3.0||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Medium Small LDL Particles||3.0|-33.8|0.0997
72476052|NCT03592745|144477963|EQUIVALENCE|Statistical analysis of the median absolute change in tricep peak sEMG amplitude from baseline to DC immediately following 3 weeks of training was measured in the active vs. sham tVNS conditions. Null hypothesis is that there is no difference in median absolute change in bicep peak sEMG amplitude between the active and sham tVNS conditions. A significance level of 0.05 was used (two-tailed).|U value|87.0||||0.445|TWO_SIDED|||||The Mann-Whitney Wilcoxon test was performed to compare median absolute change in tricep peak sEMG amplitude from baseline to 3 weeks (discharge) across two separate study conditions (active vs. sham tVNS).|Wilcoxon (Mann-Whitney)|||||||0.445
72476053|NCT03592745|144477963|EQUIVALENCE|Statistical analysis of the median absolute change in bicep peak sEMG amplitude from baseline to week 16 (3 month follow-up after training) was measured in the active vs. sham tVNS conditions. Null hypothesis is that there is no difference in median absolute change in bicep peak sEMG amplitude between the active and sham tVNS conditions. A significance level of 0.05 was used (two-tailed).|U value|95.0||||0.678|TWO_SIDED|||||The Mann-Whitney Wilcoxon test was performed to compare the median absolute change in bicep peak sEMG from baseline to 16 weeks (follow-up) across two separate study conditions (active vs. sham tVNS).|Wilcoxon (Mann-Whitney)|||||||0.678
72476054|NCT03592745|144477963|EQUIVALENCE|Statistical analysis of the median absolute change in tricep peak sEMG amplitude from baseline to week 16 (3 month follow-up after training) was measured in the active vs. sham tVNS conditions. Null hypothesis is that there is no difference in median absolute change in bicep peak sEMG amplitude between the active and sham tVNS conditions. A significance level of 0.05 was used (two-tailed).|U value|98.0||||0.777|TWO_SIDED|||||The Mann-Whitney Wilcoxon test was performed to compare the median absolute change in tricep peak sEMG from baseline to 16 weeks (follow-up) across two separate study conditions (active vs. sham tVNS).|Wilcoxon (Mann-Whitney)|||||||0.777
72476055|NCT03592745|144477964|EQUIVALENCE|Statistical analysis of median change from baseline to DC immediately following 3 weeks of training was assessed with the upper extremity fugl meyer score in the active vs. sham tDCS conditions. Null hypothesis is that there is no difference in median change in upper extremity fugl meyer score between the active and sham tDCS conditions. A significance level of 0.05 was used (two-tailed).|U value|112.0||||1|TWO_SIDED|||||The Mann-Whitney Wilcoxon test was performed to compare median change in Upper Extremity Fugl Meyer score from baseline to 3 weeks (discharge) across two separate study conditions (active vs. sham tVNS).|Wilcoxon (Mann-Whitney)|||||||1.000
72507972|NCT00570739|144547520|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-93.7||||0.0069|TWO_SIDED|95.0|-161.6|-25.9||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Very Small LDL Particles||-25.9|-161.6|0.0069
72507973|NCT00570739|144547520|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-91.4||||0.0052|TWO_SIDED|95.0|-155.2|-27.5||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Very Small LDL Particles||-27.5|-155.2|0.0052
72507974|NCT00570739|144547520|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.94||||0.0524|TWO_SIDED|95.0|-0.01|1.9||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Total High Density Lipoprotein (HDL) Particles||1.90|-0.01|0.0524
72507975|NCT00570739|144547520|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.01||||0.0301|TWO_SIDED|95.0|0.1|1.91||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Total High Density Lipoprotein (HDL) Particles||1.91|0.10|0.0301
72507976|NCT00570739|144547520|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.45||||0.0416|TWO_SIDED|95.0|0.02|0.89||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Large HDL Particles||0.89|0.02|0.0416
72507977|NCT00570739|144547520|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.46||||0.0333|TWO_SIDED|95.0|0.04|0.88||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Large HDL Particles||0.88|0.04|0.0333
72507978|NCT00570739|144547520|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.69||||0.0693|TWO_SIDED|95.0|-0.05|1.44||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Medium HDL Particles||1.44|-0.05|0.0693
72507979|NCT00570739|144547520|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.85||||0.0187|TWO_SIDED|95.0|0.14|1.56||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Medium HDL Particles||1.56|0.14|0.0187
72507980|NCT00570739|144547520|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3||||0.5765|TWO_SIDED|95.0|-1.34|0.75||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Small HDL Particles||0.75|-1.34|0.5765
72507981|NCT00570739|144547520|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.36||||0.4762|TWO_SIDED|95.0|-1.35|0.63||P-Value is for the LS Mean Difference between treatment group|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Small HDL Particles||0.63|-1.35|0.4762
72507982|NCT00570739|144547521|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.21||||0.0652|TWO_SIDED|95.0|-0.14|4.57||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Very Low Density Lipoprotein Particles||4.57|-0.14|0.0652
72507983|NCT00570739|144547521|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.74||||0.0137|TWO_SIDED|95.0|0.57|4.92||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Very Low Density Lipoprotein Particles||4.92|0.57|0.0137
72507984|NCT00570739|144547521|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.05||||0.4726|TWO_SIDED|95.0|-0.2|0.09||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Low Density Lipoprotien Particles||0.09|-0.20|0.4726
72623224|NCT05796245|144777086|OTHER|Estimation|Cox Proportional Hazard|1.7|||||TWO_SIDED|95.0|0.16|17.61|||||Hazard Ratio of Exposed/Reference, where Exposed is Infliximab-Pfizer Biosimilar and Reference is Remicade.|Comparative analysis set, IPTW weighted||17.61|0.16|
72507985|NCT00570739|144547521|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.04||||0.5715|TWO_SIDED|95.0|-0.17|0.1||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Low Density Lipoprotein Particles||0.10|-0.17|0.5715
72507986|NCT00570739|144547521|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.08||||0.0083|TWO_SIDED|95.0|0.02|0.15||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||High Density Lipoprotein Particles||0.15|0.02|0.0083
72507987|NCT00570739|144547521|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.09||||0.0022|TWO_SIDED|95.0|0.03|0.15||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||High Density Lipoprotein Particles||0.15|0.03|0.0022
72507988|NCT00570739|144547522|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|26.0||||0.0036|TWO_SIDED|95.0|8.6|43.5||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks||43.5|8.6|0.0036
72476056|NCT03592745|144477964|EQUIVALENCE|Statistical analysis of median change from baseline to week 16 (3 month follow-up) was assessed with the Upper Extremity Fugl Meyer score in the active vs. sham tVNS conditions. Null hypothesis is that there is no difference in median change in Upper Extremity Fugl Meyer score between the active and sham tVNS conditions. A significance level of 0.05 was used (two-tailed).|U value|110.5||||0.95|TWO_SIDED|||||The Mann-Whitney Wilcoxon test was performed to compare median change in Upper Extremity Fugl Meyer score from baseline to 16 weeks (follow-up) across two separate study conditions (active vs. sham tVNS).|Wilcoxon (Mann-Whitney)|||||||0.950
72476057|NCT04927247|144478003|OTHER||Difference in percentage|7.9||||0.6302|TWO_SIDED|95.0|-15.8|31.7|||Exact Cochran-Mantel-Haenszel test|||||31.7|-15.8|0.6302
72476058|NCT04927247|144478004|OTHER||Hazard Ratio (HR)|0.97||||0.9382|TWO_SIDED|95.0|0.43|2.16|||Stratified log-rank test|||||2.16|0.43|0.9382
72476059|NCT04927247|144478005|OTHER||Difference in percentage|-16.8||||0.1143|TWO_SIDED|95.0|-34.4|0.8|||Exact Cochran-Mantel-Haenszel test|||||0.8|-34.4|0.1143
72476060|NCT04927247|144478006|OTHER||Rate ratio|1.09||||0.7549|TWO_SIDED|95.0|0.63|1.89|||Negative binomial model|||||1.89|0.63|0.7549
72476061|NCT04664400|144478043|OTHER|Paired t test, testing whether the within participant difference is larger than 0.||||||0.043|||||||t-test, 1 sided|||||||0.043
72476062|NCT04664400|144478044|OTHER|Paired t test, testing whether the within participant difference is larger than 0.||||||0.036|||||||t-test, 1 sided|||||||0.036
72476063|NCT04664400|144478045|OTHER|Paired t test, testing whether the within participant difference is larger than 0.||||||0.012|||||||t-test, 1 sided|||||||0.012
72476064|NCT04664400|144478046|OTHER|Paired t test, testing whether the within participant difference is larger than 0.||||||0.835|||||||t-test, 1 sided|||||||0.835
72476065|NCT01781078|144478056|NON_INFERIORITY|The difference in the success rate between the 2 randomized groups was compared to 10% using a one-sided Farrington-Manning score test for non-inferiority at a significance level of 0.05.|difference|-0.3|||<|0.0001|ONE_SIDED|95.0||3.9|||Farrington-Manning score test|||||3.9||<0.0001
72476066|NCT01781078|144478057|NON_INFERIORITY|The difference in the success rate between the 2 randomized groups was compared to 10% using a one-sided Farrington-Manning score test for non-inferiority at a significance level of 0.05.|difference|-0.1||||0.0006|ONE_SIDED|95.0||5.0|||Farrington-Manning score test|||||5.0||0.0006
72476067|NCT01781078|144478057|NON_INFERIORITY|The difference in the success rate between the 2 randomized groups was compared to 10% using a one-sided Farrington-Manning score test for non-inferiority at a significance level of 0.05.|difference|0.0||||0.0002|ONE_SIDED|95.0||4.7|||Farrington-Manning score test|||||4.7||0.0002
72476068|NCT01081132|144478059|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.026|||<|0.001|TWO_SIDED|95.0|-8.865|-3.187|||Mixed Models Repeated Measures Analysis|||||-3.187|-8.865|<0.001
72507989|NCT00570739|144547522|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|27.2||||0.001|TWO_SIDED|95.0|11.2|43.3||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks LOCF||43.3|11.2|0.0010
72507990|NCT00570739|144547523|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|29.8||||0.0008|TWO_SIDED|95.0|12.5|47.0||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks||47.0|12.5|0.0008
72623225|NCT05796245|144777086|OTHER|Estimation|Risk Ratio (RR)|1.85|||||TWO_SIDED|95.0|0.17|19.79|||||Risk Ratio of Exposed/Reference, where Exposed is Infliximab-Pfizer Biosimilar and Reference is Remicade.|Comparative analysis set, IPTW weighted||19.79|0.17|
72476069|NCT01081132|144478060|SUPERIORITY_OR_OTHER_LEGACY|||||||0.01|||||||Cochran-Mantel-Haenszel|||||||0.010
72476070|NCT01081132|144478061|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.115||||0.104|TWO_SIDED|95.0|-0.254|0.024|||Mixed Models Repeated Measures Analysis|||||0.024|-0.254|0.104
72476071|NCT01081132|144478062|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.057||||0.408|TWO_SIDED|95.0|-0.192|0.078|||Mixed Models Repeated Measures Analysis|||||0.078|-0.192|0.408
72476072|NCT01081132|144478063|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.083||||0.176|TWO_SIDED|95.0|-0.203|0.037|||Mixed Models Repeated Measures Analysis|||||0.037|-0.203|0.176
72476073|NCT01081132|144478064|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.05||||0.253|TWO_SIDED|95.0|-0.136|-0.036|||Mixed Models Repeated Measures Analysis|||||-0.036|-0.136|0.253
72476074|NCT01081132|144478065|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.004||||0.912|TWO_SIDED|95.0|-0.061|0.068|||Mixed Models Repeated Measures Analysis|||||0.068|-0.061|0.912
72476075|NCT01081132|144478066|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.029||||0.606|TWO_SIDED|95.0|-0.139|0.081|||Mixed Models Repeated Measures Analysis|||||0.081|-0.139|0.606
72476076|NCT01081132|144478067|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.102||||0.228|TWO_SIDED|95.0|-0.064|0.268|||Mixed Models Repeated Measures Analysis|||||0.268|-0.064|0.228
72476077|NCT01081132|144478068|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.047||||0.41|TWO_SIDED|95.0|-0.159|0.065|||Mixed Models Repeated Measures Analysis|||||0.065|-0.159|0.410
72476078|NCT01081132|144478069|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.208||||0.082|TWO_SIDED|95.0|-0.443|0.026|||Mixed Models Repeated Measures Analysis|||||0.026|-0.443|0.082
72476079|NCT01081132|144478070|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
72476080|NCT01081132|144478071|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.3||||0.134|TWO_SIDED|95.0|-5.3|0.7|||Mixed Models Repeated Measures Analysis|||Global Executive Composite||0.7|-5.3|0.134
72476081|NCT01081132|144478071|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.9||||0.579|TWO_SIDED|95.0|-4.0|2.3|||Mixed Models Repeated Measures Analysis|||Behavioral Regulation Index||2.3|-4.0|0.579
72476082|NCT01081132|144478071|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.7||||0.072|TWO_SIDED|95.0|-5.6|0.2|||Mixed Models Repeated Measures Analysis|||Metacognition Index||0.2|-5.6|0.072
72476083|NCT01081132|144478072|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.5||||0.465|TWO_SIDED|95.0|-1.8|0.8|||Mixed Models Repeated Measures Analysis|||||0.8|-1.8|0.465
72476084|NCT05038163|144478098|SUPERIORITY||Treatment Effect|-0.51|||<|0.001|TWO_SIDED|95.0|-0.63|-0.39|||Regression, Linear|||||-0.39|-0.63|<0.001
72476085|NCT05038163|144478098|SUPERIORITY||Treatment Effect|-0.45|||<|0.001|TWO_SIDED|95.0|-0.57|-0.33|||Regression, Linear|||||-0.33|-0.57|<0.001
72476086|NCT05038163|144478098|SUPERIORITY||Treatment Effect|-0.34|||<|0.001|TWO_SIDED|95.0|-0.44|-0.24|||Regression, Linear|||||-0.24|-0.44|<0.001
72476087|NCT05038163|144478099|SUPERIORITY||Treatment Effect|-0.33||||0.003|TWO_SIDED|95.0|-0.55|-0.11|||Regression, Linear|||||-0.11|-0.55|0.003
72476088|NCT05038163|144478099|SUPERIORITY||Treatment Effect|-0.61|||<|0.001|TWO_SIDED|95.0|-0.87|-0.35|||Regression, Linear|||||-0.35|-0.87|<0.001
72476089|NCT05038163|144478099|SUPERIORITY||Treatment Effect|-0.25|||<|0.001|TWO_SIDED|95.0|-0.48|-0.17|||Regression, Linear|||||-0.17|-0.48|<0.001
72507991|NCT00570739|144547523|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|30.7||||0.0002|TWO_SIDED|95.0|14.9|46.6||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks LOCF||46.6|14.9|0.0002
72507992|NCT00570739|144547524|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.6||||0.0033|TWO_SIDED|95.0|0.9|4.3||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks||4.3|0.9|0.0033
72476090|NCT05038163|144478100|SUPERIORITY||Treatment Effect|-0.5|||<|0.001|TWO_SIDED|95.0|-0.67|-0.32|||Regression, Linear||Unit: $ per 12-pack|Gender subgroup: Female or other||-0.32|-0.67|<0.001
72476091|NCT05038163|144478100|SUPERIORITY||Treatment Effect|-0.53|||<|0.001|TWO_SIDED|95.0|-0.7|-0.36|||Regression, Linear||Unit: $ per 12-pack|Gender subgroup: Male||-0.36|-0.70|<0.001
72476092|NCT05038163|144478100|SUPERIORITY||Treatment Effect|-0.41|||<|0.001|TWO_SIDED|95.0|-0.57|-0.25|||Regression, Linear||Unit: $ per 12-pack|Gender subgroup: Female or other||-0.25|-0.57|<0.001
72476093|NCT05038163|144478100|SUPERIORITY||Treatment Effect|-0.48|||<|0.001|TWO_SIDED|95.0|-0.65|-0.32|||Regression, Linear||Unit: $ per 12-pack|Gender subgroup: Male||-0.32|-0.65|<0.001
72476094|NCT05038163|144478100|SUPERIORITY||Treatment Effect|-0.28|||<|0.001|TWO_SIDED|95.0|-0.42|-0.14|||Regression, Linear||Unit: $ per 12-pack|Gender subgroup: Female or other||-0.14|-0.42|<0.001
72476095|NCT05038163|144478100|SUPERIORITY||Treatment Effect|-0.57|||<|0.001|TWO_SIDED|95.0|-0.57|-0.27|||Regression, Linear|||Gender subgroup: Male|Unit: $ per 12-pack|-0.27|-0.57|<0.001
72476096|NCT05038163|144478100|SUPERIORITY||Treatment Effect|-2.23|||<|0.001|TWO_SIDED|95.0|-3.34|-1.12|||Regression, Linear||Unit: $ per 12-pack|Race subgroup: American Indian or Alaska Native||-1.12|-3.34|<0.001
72476097|NCT05038163|144478100|SUPERIORITY||Treatment Effect|-0.69|||<|0.001|TWO_SIDED|95.0|-1.15|-0.23|||Regression, Linear||Unit: $ per 12-pack|Race subgroup: Asian||-0.23|-1.15|<0.001
72476098|NCT05038163|144478100|SUPERIORITY||Treatment Effect|0.8|||<|0.001|TWO_SIDED|95.0|0.8|0.8|||Regression, Linear||Unit: $ per 12-pack|Race subgroup: Native Hawaiian or Pacific Islander||0.80|0.80|<0.001
72476099|NCT05038163|144478100|SUPERIORITY||Treatment Effect|0.45|||<|0.001|TWO_SIDED|95.0|-0.24|1.14|||Regression, Linear||Unit: $ per 12-pack|Race subgroup: Black or African American||1.14|-0.24|<0.001
72476100|NCT05038163|144478100|SUPERIORITY||Treatment Effect|-0.5|||<|0.001|TWO_SIDED|95.0|-0.63|-0.37|||Regression, Linear||Unit: $ per 12-pack|Race subgroup: White||-0.37|-0.63|<0.001
72476101|NCT05038163|144478100|SUPERIORITY||Treatment Effect|-0.96|||<|0.001|TWO_SIDED|95.0|-1.67|-0.25|||Regression, Linear||Unit: $ per 12-pack|Race subgroup: More Than One Race||-0.25|-1.67|<0.001
72476102|NCT05038163|144478100|SUPERIORITY||Treatment Effect|-0.38|||<|0.001|TWO_SIDED|95.0|-1.16|0.4|||Regression, Linear||Unit: $ per 12-pack|Race subgroup: Unknown or Not Reported||0.40|-1.16|<0.001
72476103|NCT05038163|144478100|SUPERIORITY||Treatment Effect|-0.44|||<|0.001|TWO_SIDED|95.0|-1.07|0.19|||Regression, Linear||Unit: $ per 12-pack|Race subgroup: American Indian or Alaska Native||0.19|-1.07|<0.001
72476104|NCT05038163|144478100|SUPERIORITY||Treatment Effect|-0.54|||<|0.001|TWO_SIDED|95.0|-0.91|-0.17|||Regression, Linear||Unit: $ per 12-pack|Race subgroup: Asian||-0.17|-0.91|<0.001
72476105|NCT05038163|144478100|SUPERIORITY||Treatment Effect|0.0|||<|0.001|TWO_SIDED|95.0|0.0|0.0|||Regression, Linear||Unit: $ per 12-pack|Race subgroup: Native Hawaiian or Pacific Islander||0.00|0.00|<0.001
72476106|NCT05038163|144478100|SUPERIORITY||Treatment Effect|0.16|||<|0.001|TWO_SIDED|95.0|-0.36|0.68|||Regression, Linear||Unit: $ per 12-pack|Race subgroup: Black or African American||0.68|-0.36|<0.001
72476107|NCT05038163|144478100|SUPERIORITY||Treatment Effect|-0.44|||<|0.001|TWO_SIDED|95.0|-0.57|-0.31|||Regression, Linear||Unit: $ per 12-pack|Race subgroup: white||-0.31|-0.57|<0.001
72476108|NCT05038163|144478100|SUPERIORITY||Treatment Effect|-1.18|||<|0.001|TWO_SIDED|95.0|-2.04|-0.32|||Regression, Linear||Unit: $ per 12-pack|Race subgroup: More Than One Race||-0.32|-2.04|<0.001
72476109|NCT05038163|144478100|SUPERIORITY||Treatment Effect|-0.38|||<|0.001|TWO_SIDED|95.0|-0.9|0.14|||Regression, Linear||Unit: $ per 12-pack|Race subgroup: Unknown or Not Reported||0.14|-0.90|<0.001
72476110|NCT05038163|144478100|SUPERIORITY||Treatment Effect|-0.79|||<|0.001|TWO_SIDED|95.0|-1.54|-0.04|||Regression, Linear||Unit: $ per 12-pack|Race subgroup: American Indian or Alaska Native||-0.04|-1.54|<0.001
72476111|NCT05038163|144478100|SUPERIORITY||Treatment Effect|-0.51|||<|0.001|TWO_SIDED|95.0|-0.9|-0.12|||Regression, Linear||Unit: $ per 12-pack|Race subgroup: Asian||-0.12|-0.90|<0.001
72476112|NCT05038163|144478100|SUPERIORITY||Treatment Effect|0.8|||<|0.001|TWO_SIDED|95.0|0.8|0.8|||Regression, Logistic||Unit: $ per 12-pack|Race subgroup: Native Hawaiian or Pacific Islander||0.80|0.80|<0.001
72476113|NCT05038163|144478100|SUPERIORITY||Treatment Effect|-0.04|||<|0.001|TWO_SIDED|95.0|-0.79|0.71|||Regression, Linear||Unit: $ per 12-pack|Race subgroup: Black or African American||0.71|-0.79|<0.001
72476114|NCT05038163|144478100|SUPERIORITY||Treatment Effect|-0.33|||<|0.001|TWO_SIDED|95.0|-0.44|-0.22|||Regression, Linear||Unit: $ per 12-pack|Race subgroup: White||-0.22|-0.44|<0.001
72476115|NCT05038163|144478100|SUPERIORITY||Treatment Effect|-0.41|||<|0.001|TWO_SIDED|95.0|-0.76|-0.06|||Regression, Linear||Unit: $ per 12-pack|Race subgroup: More Than One Race||-0.06|-0.76|<0.001
72476116|NCT05038163|144478100|SUPERIORITY||Treatment Effect|-0.27|||<|0.001|TWO_SIDED|95.0|-0.85|0.31|||Regression, Linear||Unit: $ per 12-pack|Race subgroup: Unknown or Not Reported||0.31|-0.85|<0.001
72476117|NCT05038163|144478100|SUPERIORITY||Treatment Effect|0.23|||<|0.001|TWO_SIDED|95.0|-0.45|0.91|||Regression, Linear||Unit: $ per 12-pack|Ethnicity subgroup: Hispanic||0.91|-0.45|<0.001
72476118|NCT05038163|144478100|SUPERIORITY||Treatment Effect|-0.52|||<|0.001|TWO_SIDED|95.0|-0.65|-0.39|||Regression, Linear||Unit: $ per 12-pack|Ethnicity subgroup: Not Hispanic||-0.39|-0.65|<0.001
72476119|NCT05038163|144478100|SUPERIORITY||Treatment Effect|-0.93|||<|0.001|TWO_SIDED|95.0|-1.48|-0.38|||Regression, Linear||Unit: $ per 12-pack|Ethnicity subgroup: Other or Prefer Not to Say||-0.38|-1.48|<0.001
72476120|NCT05038163|144478100|SUPERIORITY||Treatment Effect|-0.16|||<|0.001|TWO_SIDED|95.0|-0.7|0.38|||Regression, Linear||Unit: $ per 12-pack|Ethnicity subgroup: Hispanic||0.38|-0.70|<0.001
72476121|NCT05038163|144478100|SUPERIORITY||Treatment Effect|-0.45|||<|0.001|TWO_SIDED|95.0|-0.57|-0.33|||Regression, Linear||Unit: $ per 12-pack|Ethnicity subgroup: Not Hispanic||-0.33|-0.57|<0.001
72476122|NCT05038163|144478100|SUPERIORITY||Treatment Effect|-0.79|||<|0.001|TWO_SIDED|95.0|-1.42|-0.16|||Regression, Linear||Unit: $ per 12-pack|Ethnicity subgroup: Other or Prefer Not to Say||-0.16|-1.42|<0.001
72476123|NCT05038163|144478100|SUPERIORITY||Treatment Effect|0.01||||0.98|TWO_SIDED|95.0|-0.4|0.41|||Regression, Linear||Unit: $ per 12-pack|Ethnicity subgroup: Hispanic||0.41|-0.40|0.980
72476124|NCT05038163|144478100|SUPERIORITY||Treatment Effect|-0.36|||<|0.001|TWO_SIDED|95.0|-0.47|-0.25|||Regression, Linear||Unit: $ per 12-pack|Ethnicity subgroup: Not Hispanic||-0.25|-0.47|<0.001
72476125|NCT05038163|144478100|SUPERIORITY||Treatment Effect|-0.39|||<|0.001|TWO_SIDED|95.0|-1.03|0.25|||Regression, Linear||Unit: $ per 12-pack|Ethnicity Subgroup: Other or Prefer Not to Say||0.25|-1.03|<0.001
72476126|NCT00383110|144478105|SUPERIORITY_OR_OTHER|||||||0.648|||||||ANOVA|||||||0.648
72476127|NCT00383110|144478106|SUPERIORITY_OR_OTHER|||||||0.14|||||||ANOVA|||||||0.14
72476128|NCT00383110|144478107|SUPERIORITY_OR_OTHER|||||||0.675|||||||ANOVA|||||||0.675
72476129|NCT00383110|144478108|SUPERIORITY_OR_OTHER|||||||0.03|||||||ANOVA|||||||0.03
72476130|NCT00383110|144478109|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA|||||||<0.001
72476131|NCT00383110|144478110|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA|||||||<0.001
72476132|NCT03762200|144478111|OTHER|Confidence Interval|percentage of sucesses|87.4|||||TWO_SIDED|95.0|79.4|93.1||||||||93.1|79.4|
72476133|NCT03762200|144478112|OTHER|Confidence Interval|Percentage of Successes|77.7|||||TWO_SIDED|95.0|68.4|85.3||||||||85.3|68.4|
72476134|NCT03762200|144478113|OTHER|Confidence Interval|Percentage of Successes|92.2|||||TWO_SIDED|95.0|85.3|96.6||||||||96.6|85.3|
72476135|NCT03973931|144478120|NON_INFERIORITY|Generalized Estimating Equation (GEE) model with an identity link and independence with unequal variances for the covariance structure of the 12 observations|||||<|0.05|||||||GEE|To account for multiple treatment comparisons significance levels of 0.05/3||||||<0.05
72476136|NCT03973931|144478121|NON_INFERIORITY|Analysis of the longitudinal data (12 observations per patient) and estimated absolute differences in PDC between treatment group and usual care was analyzed using Generalized Estimating Equation (GEE) model with an identity link and independence with unequal variances for the covariance structure was used.|||||<|0.05||||||To account for multiple treatment comparisons significance levels of 0.05/3, and if any test was significant, a significance level of (R/3)\*(0.05/3) using the Holm method was used for the 3 pairwise comparisons, R=number of significant stage 1 tests.|GEE|||||||<0.05
72476137|NCT00925353|144478128|SUPERIORITY_OR_OTHER||Actual lab results shown|1.0|||<|0.05||95.0|||||non-compartmental pharmacokinetic|The planned analysis was to estimate pharmacokinetic parameters. There were too few detectable values to be able to perform this analysis.||Null Hypothesis: Application of 4% lidocaine gel on the breasts and chest wall of healthy women occluded for one hour does not result in systemically toxic plasma concentrations of lidocaine or its principal metabolite, monoethylglycinexyliidie (MEGX), electrocardiogram changes, or adverse events.||||<0.05
72476138|NCT02980731|144478135|SUPERIORITY||||||=|0.004||||||P-value is derived from a paired t-test of H0: mean difference (Week 48 - baseline) ≤ 5 versus H1: mean difference (Week 48 - baseline) \> 5|t-test, 2 sided|||||||=0.004
72476139|NCT00605215|144478168|OTHER||Risk Ratio (RR)|0.823|STANDARD_ERROR_OF_MEAN|0.09||0.0746|TWO_SIDED|95.0|0.664|1.02||Threshold for significance at 0.05 level.|Negative Binomial Regression|||Analysis was performed using baseline-adjusted negative binomial regression, where a participant's number of relapses during the double-blind, placebo-controlled phase served as the response variable and an offset based on the log of participant's exposure in years was employed to adjust for variability of treatment exposure. The model included baseline EDSS score, log of (prior 2-year number of relapses+1) and CGR as covariates.||1.020|0.664|0.0746
72476140|NCT00605215|144478168|OTHER||Risk Ratio (RR)|0.741|STANDARD_ERROR_OF_MEAN|0.082||0.0067|TWO_SIDED|95.0|0.596|0.92|||Negative Binomial Regression|||Analysis was performed using baseline-adjusted negative binomial regression, where a participant's number of relapses during the double-blind, placebo-controlled phase served as the response variable and an offset based on the log of participant's exposure in years was employed to adjust for variability of treatment exposure. The model included baseline EDSS score, log of (prior 2-year number of relapses+1) and CGR as covariates.||0.920|0.596|0.0067
72476141|NCT02914275|144478179|NON_INFERIORITY|The non-inferiority criterion for the GMT ratio (adjusted analysis) was that the upper bound of the two-sided 95% confidence interval (CI) of the GMT ratio for the Comparator QIV GMT, divided by the Seqirus QIV GMT, should not exceed 1.5|Geometric Mean Titer Ratio|0.79|||||TWO_SIDED|95.0|0.72|0.88||||||Non-inferiority of immune responses to A/H1N1 vaccine strain measured in terms of Geometric Mean Titer ratios 28 days after the last vaccination||0.88|0.72|
72476142|NCT02914275|144478179|NON_INFERIORITY|The non-inferiority criterion for the GMT ratio (adjusted analysis) was that the upper bound of the two-sided 95% CI of the GMT ratio for the Comparator QIV GMT, divided by the Seqirus QIV GMT, should not exceed 1.5|Geometric Mean Titer Ratio|1.27|||||TWO_SIDED|95.0|1.15|1.42||||||Non-inferiority of immune responses to A/H3N2 vaccine strain measured in terms of Geometric Mean Titer ratios 28 days after the last vaccination||1.42|1.15|
72476143|NCT02914275|144478179|NON_INFERIORITY|The non-inferiority criterion for the GMT ratio (adjusted analysis) was that the upper bound of the two-sided 95% CI of the GMT ratio for the Comparator QIV GMT, divided by the Seqirus QIV GMT, should not exceed 1.5|Geometric Mean Titer Ratio|1.12|||||TWO_SIDED|95.0|1.01|1.24||||||Non-inferiority of immune responses to B/YAM vaccine strain measured in terms of Geometric Mean Titer ratios 28 days after the last vaccination||1.24|1.01|
72476144|NCT02914275|144478179|NON_INFERIORITY|The non-inferiority criterion for the GMT ratio (adjusted analysis) was that the upper bound of the two-sided 95% CI of the GMT ratio for the Comparator QIV GMT, divided by the Seqirus QIV GMT, should not exceed 1.5|Geometric Mean Titer Ratio|0.97|||||TWO_SIDED|95.0|0.86|1.09||||||Non-inferiority of immune responses to B/VIC vaccine strain measured in terms of Geometric Mean Titer ratios 28 days after the last vaccination||1.09|0.86|
72476145|NCT02914275|144478180|NON_INFERIORITY|The noninferiority criterion for the SCR difference was that the upper bound of the two-sided 95% CI on the difference between SCRs for Comparator QIV minus the Seqirus QIV SCR should not exceed 10%.|Seroconversion Rate Difference|-10.3|||||TWO_SIDED|95.0|-15.4|-5.1||||||Non-inferiority of immune responses to A/H1N1 vaccine strain measured in terms of Seroconversion Rate Difference 28 days after the last vaccination||-5.1|-15.4|
72476146|NCT02914275|144478180|NON_INFERIORITY|The noninferiority criterion for the SCR difference was that the upper bound of the two-sided 95% CI on the difference between SCRs for Comparator QIV minus the Seqirus QIV SCR should not exceed 10%.|Seroconversion Rate Difference|2.6|||||TWO_SIDED|95.0|-2.54|7.8||||||Non-inferiority of immune responses to A/H3N2 vaccine strain measured in terms of Seroconversion Rate Difference 28 days after the last vaccination||7.8|-2.54|
72507993|NCT00570739|144547524|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.8||||0.0008|TWO_SIDED|95.0|1.2|4.4||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks LOCF||4.4|1.2|0.0008
72507994|NCT00570739|144547525|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.26||||0.0035|TWO_SIDED|95.0|-0.44|-0.09||P-Value is for the LS mean difference between the treatment groups|ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||||-0.09|-0.44|0.0035
72507995|NCT00570739|144547526|SUPERIORITY_OR_OTHER|||||||0.5848||95.0|||||Cochran-Mantel-Haenszel|Stratified by country.||Baseline to 4 Weeks||||0.5848
72507996|NCT00570739|144547526|SUPERIORITY_OR_OTHER|||||||0.8147||95.0|||||Cochran-Mantel-Haenszel|Stratified by country||Baseline to 8 weeks||||0.8147
72507997|NCT00570739|144547526|SUPERIORITY_OR_OTHER|||||||0.4957||95.0|||||Cochran-Mantel-Haenszel|Stratified by country||Baseline to 12 Weeks||||0.4957
72476147|NCT02914275|144478180|NON_INFERIORITY|The noninferiority criterion for the SCR difference was that the upper bound of the two-sided 95% CI on the difference between SCRs for Comparator QIV minus the Seqirus QIV SCR should not exceed 10%.|Seroconversion Rate Difference|3.1|||||TWO_SIDED|95.0|-2.1|8.2||||||Non-inferiority of immune responses to B/YAM vaccine strain measured in terms of Seroconversion Rate Difference 28 days after the last vaccination||8.2|-2.1|
72507998|NCT00570739|144547526|SUPERIORITY_OR_OTHER|||||||0.0467||95.0|||||Cochran-Mantel-Haenszel|Stratified by country||Baseline to 16 Weeks||||0.0467
72507999|NCT00570739|144547526|SUPERIORITY_OR_OTHER|||||||0.0589||95.0|||||Cochran-Mantel-Haenszel|Stratified by country.||Baseline to 16 Weeks LOCF||||0.0589
72508000|NCT00570739|144547526|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.9||||0.0049|TWO_SIDED|95.0|1.38|6.1|||Regression, Logistic|Contained treatment and country as factors and baseline lab value as a covariate||Baseline to 16 Weeks||6.10|1.38|0.0049
72476148|NCT02914275|144478180|NON_INFERIORITY|The noninferiority criterion for the SCR difference was that the upper bound of the two-sided 95% CI on the difference between SCRs for Comparator QIV minus the Seqirus QIV SCR should not exceed 10%.|Seroconversion Rate Difference|0.9|||||TWO_SIDED|95.0|-4.2|6.1||||||Non-inferiority of immune responses to B/VIC vaccine strain measured in terms of Seroconversion Rate Difference 28 days after the last vaccination||6.1|-4.2|
72476149|NCT01302067|144478191|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.91|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-1.16|-0.66||Primary comparison was 8 mg VS. 4 mg (closed-testing method). Treatment effect of 8 mg VS. placebo was tested 1st. Treatment difference of 8 mg VS. 4 mg was tested if a statistically significant difference between 8 mg and placebo was shown.|ANCOVA|Using a closed testing procedure, no adjustments of α-level was needed at each stage of testing. Each was done at the 0.05 significance level.|Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.|Comparisons were done with 2-sided test at 5% significance level. Null hypothesis: mean change from BL in the number of UUI episodes per 24 hours in the 8mg group was same as 4mg group at Week 12. ANCOVA was used to compare 8mg and 4mg arms for numeric change from BL - Week 12. This included terms for treatment, country, centered BL value and centered BL by treatment interaction, in which centered BL (BL - mean BL) was used to ensure that treatment effect was estimated at mean covariate value.||-0.66|-1.16|<0.0001
72476150|NCT01302067|144478191|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.27|STANDARD_ERROR_OF_MEAN|0.11||0.0109|TWO_SIDED|95.0|-0.48|-0.06||A closed-testing procedure was used for the treatment comparison.|ANCOVA||Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.|Treatment comparisons were performed with a two-sided test at the 5% significance level.||-0.06|-0.48|0.0109
72476151|NCT01302067|144478191|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.64|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-0.89|-0.39||A closed-testing procedure was used for the treatment comparison.|ANCOVA||Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.|Treatment comparisons were performed with a two-sided test at the 5% significance level.||-0.39|-0.89|<0.0001
72476152|NCT01302067|144478192|SUPERIORITY_OR_OTHER||Least squares mean difference|-1.13|STANDARD_ERROR_OF_MEAN|0.18|<|0.0001|TWO_SIDED|95.0|-1.48|-0.79||A closed-testing procedure was used for the treatment comparison.|ANCOVA||Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.|P-value was based on an ANCOVA model with terms for treatment, pooled country, and centered baseline value.||-0.79|-1.48|<0.0001
72476153|NCT01302067|144478192|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.38|STANDARD_ERROR_OF_MEAN|0.14||0.0082|TWO_SIDED|95.0|-0.67|-0.1||A closed-testing procedure was used for the treatment comparison.|ANCOVA||Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.|P-value was based on an ANCOVA model with terms for treatment, pooled country, and centered baseline value.||-0.10|-0.67|0.0082
72476154|NCT01302067|144478192|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.75|STANDARD_ERROR_OF_MEAN|0.18|<|0.0001|TWO_SIDED|95.0|-1.1|-0.41||A closed-testing procedure was used for the treatment comparison.|ANCOVA||Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.|P-value was based on an ANCOVA model with terms for treatment, pooled country, and centered baseline value.||-0.41|-1.10|<0.0001
72476155|NCT01302067|144478193|SUPERIORITY_OR_OTHER||Least squares mean difference|-1.4|STANDARD_ERROR_OF_MEAN|0.19|<|0.0001|TWO_SIDED|95.0|-1.76|-1.03||A closed-testing procedure was used for the treatment comparison.|ANCOVA||Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.|P-value was based on an ANCOVA model with terms for treatment, pooled country, and centered baseline value.||-1.03|-1.76|<0.0001
72476156|NCT01302067|144478193|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.53|STANDARD_ERROR_OF_MEAN|0.15||0.0006|TWO_SIDED|95.0|-0.83|-0.23||A closed-testing procedure was used for the treatment comparison.|ANCOVA||Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.|P-value was based on an ANCOVA model with terms for treatment, pooled country, and centered baseline value.||-0.23|-0.83|0.0006
72476157|NCT01302067|144478193|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.87|STANDARD_ERROR_OF_MEAN|0.19|<|0.0001|TWO_SIDED|95.0|-1.23|-0.51||A closed-testing procedure was used for the treatment comparison.|ANCOVA||Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.|P-value was based on an ANCOVA model with terms for treatment, pooled country, and centered baseline value.||-0.51|-1.23|<0.0001
72476158|NCT01302067|144478194|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||A closed-testing procedure was used for the treatment comparison.|ANCOVA|Testing for percent change from baseline was only carried out for given endpoint if corresponding numeric change result was statistically significant.||P-value was based on a RANKED ANCOVA model with terms for treatment and pooled country with ranked baseline value as a covariate.||||<0.0001
72476159|NCT01302067|144478194|SUPERIORITY_OR_OTHER|||||||0.004|TWO_SIDED|||||A closed-testing procedure was used for the treatment comparison.|ANCOVA|Testing for percent change from baseline was only carried out for given endpoint if corresponding numeric change result was statistically significant.||P-value was based on a RANKED ANCOVA model with terms for treatment and pooled country with ranked baseline value as a covariate.||||0.0040
72476160|NCT01302067|144478194|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||A closed-testing procedure was used for the treatment comparison.|ANCOVA|Testing for percent change from baseline was only carried out for given endpoint if corresponding numeric change result was statistically significant.||P-value was based on a RANKED ANCOVA model with terms for treatment and pooled country with ranked baseline value as a covariate.||||<0.0001
72476161|NCT01302067|144478195|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||A closed-testing procedure was used for the treatment comparison.|ANCOVA|Testing for percent change from baseline was only carried out for given endpoint if corresponding numeric change result was statistically significant.||P-value was based on a RANKED ANCOVA model with terms for treatment and pooled country with ranked baseline value as a covariate.||||<0.0001
72476162|NCT01302067|144478195|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||A closed-testing procedure was used for the treatment comparison.|ANCOVA|Testing for percent change from baseline was only carried out for given endpoint if corresponding numeric change result was statistically significant.||P-value was based on a RANKED ANCOVA model with terms for treatment and pooled country with ranked baseline value as a covariate.||||<0.0001
72508001|NCT00570739|144547526|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.44||||0.0092|TWO_SIDED|95.0|1.25|4.76|||Regression, Logistic|Contained treatment and country as factors and baseline lab value as a covariate||Baseline to 16 Weeks LOCF||4.76|1.25|0.0092
72508002|NCT00570739|144547527|SUPERIORITY_OR_OTHER|||||||0.0008||95.0|||||Cochran-Mantel-Haenszel|Startified by country||Baseline to 4 Weeks||||0.0008
72476163|NCT01302067|144478195|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||A closed-testing procedure was used for the treatment comparison.|ANCOVA|Testing for percent change from baseline was only carried out for given endpoint if corresponding numeric change result was statistically significant.||P-value was based on a RANKED ANCOVA model with terms for treatment and pooled country with ranked baseline value as a covariate.||||<0.0001
72476164|NCT01302067|144478196|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.76|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-1.02|-0.5||A closed-testing procedure was used for the treatment comparison.|ANCOVA||Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.|P-value was based on an ANCOVA model with terms for treatment, pooled country, centered baseline value and centered baseline by treatment interaction.||-0.50|-1.02|<0.0001
72476165|NCT01302067|144478196|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.11||0.0662|TWO_SIDED|95.0|-0.41|0.01||A closed-testing procedure was used for the treatment comparison.|ANCOVA||Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.|P-value was based on an ANCOVA model with terms for treatment, pooled country, centered baseline value and centered baseline by treatment interaction.||0.01|-0.41|0.0662
72476166|NCT01302067|144478196|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.56|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-0.82|-0.3||A closed-testing procedure was used for the treatment comparison.|ANCOVA||Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.|P-value was based on an ANCOVA model with terms for treatment, pooled country, centered baseline value and centered baseline by treatment interaction.||-0.30|-0.82|<0.0001
72476167|NCT01302067|144478197|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||A closed-testing procedure was used for the treatment comparison.|ANCOVA|Testing for percent change from baseline was only carried out for given endpoint if corresponding numeric change result was statistically significant||P-value was based on a RANKED ANCOVA model with terms for treatment and pooled country with ranked baseline value as a covariate.||||<0.0001
72476168|NCT01302067|144478197|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||A closed-testing procedure was used for the treatment comparison.|ANCOVA|Testing for percent change from baseline was only carried out for given endpoint if corresponding numeric change result was statistically significant||P-value was based on a RANKED ANCOVA model with terms for treatment and pooled country with ranked baseline value as a covariate.||||<0.0001
72476169|NCT01302067|144478198|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||A closed-testing procedure was used for the treatment comparison.|ANCOVA|Testing for percent change from baseline was only carried out for given endpoint if corresponding numeric change result was statistically significant||P-value was based on a RANKED ANCOVA model with terms for treatment and pooled country with ranked baseline value as a covariate.||||<0.0001
72508003|NCT00570739|144547527|SUPERIORITY_OR_OTHER|||||||0.028||95.0|||||Cochran-Mantel-Haenszel|Stratified by country||Baseline to 8 Weeks||||0.0280
72508004|NCT00570739|144547527|SUPERIORITY_OR_OTHER|||||||0.0414||95.0|||||Cochran-Mantel-Haenszel|Stratified by country||Baseline to 12 Weeks||||0.0414
72508005|NCT00570739|144547527|SUPERIORITY_OR_OTHER|||||||0.084||95.0|||||Cochran-Mantel-Haenszel|Stratified by country||Baseline to 16 Weeks||||0.0840
72508006|NCT00570739|144547527|SUPERIORITY_OR_OTHER|||||||0.0589||95.0|||||Cochran-Mantel-Haenszel|Stratified by country||Baseline to 16 Weeks LOCF||||0.0589
72476170|NCT01302067|144478198|SUPERIORITY_OR_OTHER|||||||0.0006|TWO_SIDED|||||A closed-testing procedure was used for the treatment comparison.|ANCOVA|Testing for percent change from baseline was only carried out for given endpoint if corresponding numeric change result was statistically significant||P-value was based on a RANKED ANCOVA model with terms for treatment and pooled country with ranked baseline value as a covariate.||||0.0006
72476171|NCT01302067|144478198|SUPERIORITY_OR_OTHER|||||||0.0001|TWO_SIDED|||||A closed-testing procedure was used for the treatment comparison.|ANCOVA|Testing for percent change from baseline was only carried out for given endpoint if corresponding numeric change result was statistically significant||P-value was based on a RANKED ANCOVA model with terms for treatment and pooled country with ranked baseline value as a covariate.||||0.0001
72476172|NCT01302067|144478199|SUPERIORITY_OR_OTHER||Least squares mean difference|-1.55|STANDARD_ERROR_OF_MEAN|0.25|<|0.0001|TWO_SIDED|95.0|-2.04|-1.06||A closed-testing procedure was used for the treatment comparison.|ANCOVA||Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.|P-value was based on an ANCOVA model with terms for treatment, pooled country, and centered baseline value.||-1.06|-2.04|<0.0001
72476173|NCT01302067|144478199|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.52|STANDARD_ERROR_OF_MEAN|0.21||0.0121|TWO_SIDED|95.0|-0.92|-0.11||A closed-testing procedure was used for the treatment comparison.|ANCOVA||Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.|P-value was based on an ANCOVA model with terms for treatment, pooled country, and centered baseline value.||-0.11|-0.92|0.0121
72476174|NCT01302067|144478199|SUPERIORITY_OR_OTHER||Least squares mean difference|-1.04|STANDARD_ERROR_OF_MEAN|0.25|<|0.0001|TWO_SIDED|95.0|-1.52|-0.55||A closed-testing procedure was used for the treatment comparison.|ANCOVA||Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.|P-value was based on an ANCOVA model with terms for treatment, pooled country, and centered baseline value.||-0.55|-1.52|<0.0001
72508007|NCT00570739|144547527|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.19||||0.0095|TWO_SIDED|95.0|1.21|3.96|||Regression, Logistic|Contained treatment and country as factors and baseline lab value as a covariate||Baseline to 16 Weeks||3.96|1.21|0.0095
72508008|NCT00570739|144547527|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.08||||0.0088|TWO_SIDED|95.0|1.2|3.6|||Regression, Logistic|Contained treatment and country as factors and baseline lab value as a covariate||Baseline to 16 Weeks LOCF||3.60|1.20|0.0088
72508009|NCT00570739|144547528|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Cochran-Mantel-Haenszel|Stratified by country||Baseline to 8 Weeks||||<0.0001
72508010|NCT00570739|144547528|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Cochran-Mantel-Haenszel|Stratified by country||Baseline to 16 Weeks||||<0.0001
72508011|NCT00570739|144547528|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Cochran-Mantel-Haenszel|Stratified by country||Baseline to 16 Weeks LOCF||||<0.0001
72508012|NCT00570739|144547528|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.59|||<|0.0001|TWO_SIDED|95.0|2.78|11.23|||Regression, Logistic|Contained treatment and country as factors and baseline lab value as a covariate||Baseline to 16 Weeks||11.23|2.78|<0.0001
72508013|NCT00570739|144547528|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.8|||<|0.0001|TWO_SIDED|95.0|2.53|9.1|||Regression, Logistic|Contained treatment and country as factors and baseline lab value as a covariate||Baseline to 16 Weeks LOCF||9.10|2.53|<0.0001
72508014|NCT00570739|144547529|SUPERIORITY_OR_OTHER|||||||0.0004||95.0|||||Cochran-Mantel-Haenszel|Stratified by country||Baseline to 8 Weeks||||0.0004
72508015|NCT00570739|144547529|SUPERIORITY_OR_OTHER|||||||0.0326||95.0|||||Cochran-Mantel-Haenszel|Stratified by country||Baseline to 16 Weeks||||0.0326
72508016|NCT00570739|144547529|SUPERIORITY_OR_OTHER|||||||0.0157||95.0|||||Cochran-Mantel-Haenszel|Stratified by country||Baseline to 16 Weeks LOCF||||0.0157
72508017|NCT00570739|144547529|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.49||||0.087|TWO_SIDED|95.0|0.88|7.07|||Regression, Logistic|Contained treatment and country as factors and baseline lab value as a covariate||Baseline to 16 Weeks||7.07|0.88|0.0870
72508018|NCT00570739|144547529|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.86||||0.00439|TWO_SIDED|95.0|1.03|7.94|||Regression, Logistic|Contained treatment and country as factors and baseline lab value as a covariate.||Baseline to 16 Weeks LOCF||7.94|1.03|0.00439
72508019|NCT00570739|144547530|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2||||0.7959|TWO_SIDED|95.0|-1.32|1.72||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks||1.72|-1.32|0.7959
72508020|NCT00570739|144547530|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.15||||0.8371|TWO_SIDED|95.0|-1.28|1.57||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks LOCF||1.57|-1.28|0.8371
72508021|NCT00570739|144547531|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.0033||||0.4584|TWO_SIDED|95.0|-0.0122|0.0055||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks||0.0055|-0.0122|0.4584
72508022|NCT00570739|144547531|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.0035||||0.4039|TWO_SIDED|95.0|-0.0118|0.0048||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks LOCF||0.0048|-0.0118|0.4039
72508023|NCT00570739|144547532|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.59|||<|0.0001|TWO_SIDED|95.0|-21.07|-10.11||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate.||||-10.11|-21.07|<0.0001
72508024|NCT00570739|144547533|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.46||||0.2289|TWO_SIDED|95.0|-27.53|6.62||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks||6.62|-27.53|0.2289
72508025|NCT00570739|144547533|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.54||||0.1997|TWO_SIDED|95.0|-29.22|6.14||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks LOCF||6.14|-29.22|0.1997
72508026|NCT00570739|144547534|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.81||||0.0144|TWO_SIDED|95.0|2.57|23.05||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Calculated Triglycerides||23.05|2.57|0.0144
72508027|NCT00570739|144547534|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.12||||0.0037|TWO_SIDED|95.0|4.63|23.61||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Calculated Triglycerides||23.61|4.63|0.0037
72508028|NCT00570739|144547534|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|22.79||||0.006|TWO_SIDED|95.0|6.59|39.0||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Calculated Very Low Density Lipoprotein Triglycerides||39.00|6.59|0.0060
72508029|NCT00570739|144547534|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|24.72||||0.0013|TWO_SIDED|95.0|9.71|39.73||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Calculated Very Low Density Lipoprotein Triglycerides||39.73|9.71|0.0013
72508030|NCT00570739|144547534|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.35||||0.0005|TWO_SIDED|95.0|3.71|13.0|||ANCOVA|||Calculated High Density Lipoprotein-Cholesterol||13.00|3.71|0.0005
72508031|NCT00570739|144547534|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.69||||0.0001|TWO_SIDED|95.0|4.27|13.11||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Calculated High Density Lipoprotein-Cholesterol||13.11|4.27|0.0001
72508032|NCT00570739|144547535|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.21||||0.8804|TWO_SIDED|95.0|0.63|2.34||P-Value for comparing percentages was from the Cochran-Mantel-Haenszel test stratified by country.|Cochran-Mantel-Haenszel|||Baseline to 16 Weeks||2.34|0.63|0.8804
72508033|NCT00570739|144547535|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.38||||0.5525|TWO_SIDED|95.0|0.73|2.6||P-Value for comparing percentages was from the Cochran-Mantel-Haenszel test stratified by country.|Cochran-Mantel-Haenszel|||Baseline to 16 Weeks LOCF||2.60|0.73|0.5525
72508034|NCT00570739|144547535|SUPERIORITY_OR_OTHER|||||||0.5648||95.0|||||Regression, Logistic|Contained treatment and country as factors and baseline lab value as a covariate||Baseline to 16 Weeks||||0.5648
72508035|NCT00570739|144547535|SUPERIORITY_OR_OTHER|||||||0.317||95.0|||||Regression, Logistic|Contained treatment and country as factors and baseline lab value as a covariate||Baseline to 16 Weeks LOCF||||0.3170
72508036|NCT00570739|144547536|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.64||||0.9008|TWO_SIDED|95.0|0.66|4.06||P-Value for comparing percentages was from the Cochran-Mantel-Haenszel test stratified by country.|Cochran-Mantel-Haenszel|||Baseline to 16 Weeks||4.06|0.66|0.9008
72508037|NCT00570739|144547536|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.4||||0.9035|TWO_SIDED|95.0|0.6|3.37||P-Value for comparing percentages was from the Cochran-Mantel-Haenszel test stratified by country.|Cochran-Mantel-Haenszel|||Baseline to 16 Weeks LOCF||3.37|0.60|0.9035
72508038|NCT00570739|144547536|SUPERIORITY_OR_OTHER|||||||0.2874||95.0|||||Regression, Logistic|Contained treatment and country as factors and baseline lab value as a covariate||Baseline to 16 Weeks||||0.2874
72508039|NCT00570739|144547536|SUPERIORITY_OR_OTHER|||||||0.4344||95.0|||||Regression, Logistic|Contained treatment and country as factors and baseline lab value as a covariate||Baseline to 16 Weeks LOCF||||0.4344
72508040|NCT00570739|144547537|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.62|||<|0.0001|TWO_SIDED|95.0|-24.61|-14.63||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 8 Weeks||-14.63|-24.61|<0.0001
72508041|NCT00570739|144547537|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.47|||<|0.0001|TWO_SIDED|95.0|-23.24|-11.69||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks||-11.69|-23.24|<0.0001
72508042|NCT00570739|144547538|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.47|||<|0.0001|TWO_SIDED|95.0|-16.26|-8.69||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 8 Weeks||-8.69|-16.26|<0.0001
72508043|NCT00570739|144547538|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.28|||<|0.0001|TWO_SIDED|95.0|-15.15|-5.41||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks||-5.41|-15.15|<0.0001
72508044|NCT00570739|144547538|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.06||||0.0002|TWO_SIDED|95.0|-13.69|-4.42||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks LOCF||-4.42|-13.69|0.0002
72508045|NCT00570739|144547539|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.96||||0.0357|TWO_SIDED|95.0|0.27|7.66||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 8 Weeks||7.66|0.27|0.0357
72508046|NCT00570739|144547539|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.85||||0.6878|TWO_SIDED|95.0|-5.01|3.31||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks||3.31|-5.01|0.6878
72508047|NCT00570739|144547539|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5||||0.7972|TWO_SIDED|95.0|-4.37|3.36||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks LOCF||3.36|-4.37|0.7972
72508048|NCT00570739|144547540|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.91|||<|0.0001|TWO_SIDED|95.0|-12.02|-5.8||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 8 Weeks||-5.80|-12.02|<0.0001
72508049|NCT00570739|144547540|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.26|||<|0.0001|TWO_SIDED|95.0|-12.25|-4.26||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks||-4.26|-12.25|<0.0001
72508050|NCT00570739|144547540|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.23||||0.0002|TWO_SIDED|95.0|-11.03|-3.44||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks LOCF||-3.44|-11.03|0.0002
72508051|NCT00570739|144547541|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.5||||0.0257|TWO_SIDED|95.0|0.43|6.57||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 8 Weeks||6.57|0.43|0.0257
72508052|NCT00570739|144547541|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.13||||0.2238|TWO_SIDED|95.0|-1.32|5.58||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks||5.58|-1.32|0.2238
72508053|NCT00570739|144547541|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.78||||0.2763|TWO_SIDED|95.0|-1.44|4.99||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks LOCF||4.99|-1.44|0.2763
72508054|NCT00570739|144547542|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.83|||<|0.0001|TWO_SIDED|95.0|-13.68|-5.98||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 8 Weeks||-5.98|-13.68|<0.0001
72476175|NCT01302067|144478200|SUPERIORITY_OR_OTHER||Least squares mean difference|-2.02|STANDARD_ERROR_OF_MEAN|0.27|<|0.0001|TWO_SIDED|95.0|-2.55|-1.49||A closed-testing procedure was used for the treatment comparison.|ANCOVA||Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.|P-value was based on an ANCOVA model with terms for treatment, pooled country, and centered baseline value.||-1.49|-2.55|<0.0001
72476176|NCT01302067|144478200|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.78|STANDARD_ERROR_OF_MEAN|0.22||0.0005|TWO_SIDED|95.0|-1.22|-0.34||A closed-testing procedure was used for the treatment comparison.|ANCOVA||Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.|P-value was based on an ANCOVA model with terms for treatment, pooled country, and centered baseline value.||-0.34|-1.22|0.0005
72476177|NCT01302067|144478200|SUPERIORITY_OR_OTHER||Least squares mean difference|-1.24|STANDARD_ERROR_OF_MEAN|0.27|<|0.0001|TWO_SIDED|95.0|-1.77|-0.71||A closed-testing procedure was used for the treatment comparison.|ANCOVA||Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.|P-value was based on an ANCOVA model with terms for treatment, pooled country, and centered baseline value.||-0.71|-1.77|<0.0001
72476178|NCT01302067|144478201|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||A closed-testing procedure was used for the treatment comparison.|ANCOVA|Testing for percent change from baseline was only carried out for given endpoint if corresponding numeric change result was statistically significant.||P-value was based on a RANKED ANCOVA model with terms for treatment and pooled country with ranked baseline value as a covariate.||||<0.0001
72508055|NCT00570739|144547542|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.67||||0.0004|TWO_SIDED|95.0|-13.4|-3.94||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks||-3.94|-13.40|0.0004
72508056|NCT00570739|144547542|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.09||||0.0004|TWO_SIDED|95.0|-12.5|-3.68||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks LOCF||-3.68|-12.50|0.0004
72508057|NCT00570739|144547543|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.8||||0.0007|TWO_SIDED|95.0|5.87|21.74||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 8 Weeks||21.74|5.87|0.0007
72508058|NCT00570739|144547543|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.58||||0.0901|TWO_SIDED|95.0|-1.83|24.99||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks||24.99|-1.83|0.0901
72508059|NCT00570739|144547543|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.45||||0.0918|TWO_SIDED|95.0|-1.71|22.62||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a||Baseline to 16 Weeks LOCF||22.62|-1.71|0.0918
72508060|NCT00570739|144547544|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|15.78||||0.0005|TWO_SIDED|95.0|6.27|25.83||P-Value is from the non-parametric ANCOVA stratified by country|ANCOVA|Non-parametric|The median difference was calculated using Hodges-Lehmann point estimates and corresponding 95% confidence interval was constructed using the method of Moses.|Baseline to 8 Weeks||25.83|6.27|0.0005
72508061|NCT00570739|144547544|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|16.07||||0.0011|TWO_SIDED|95.0|6.33|26.02||P-Value is from the non-parametric ANCOVA stratified by country|ANCOVA|Non-parametric|The median difference was calculated using Hodges-Lehmann point estimates and corresponding 95% confidence interval was constructed using the method of Moses.|Baseline to 16 Weeks||26.02|6.33|0.0011
72508062|NCT00570739|144547544|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|14.33||||0.0009|TWO_SIDED|95.0|5.11|23.84||P-Value is from the non-parametric ANCOVA stratified by country|ANCOVA|Non-parametric|The median difference was calculated using Hodges-Lehmann point estimates and corresponding 95% confidence interval was constructed using the method of Moses.|Baseline to 16 Weeks LOCF||23.84|5.11|0.0009
72508063|NCT00570739|144547545|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-3.29||||0.6523|TWO_SIDED|95.0|-17.5|10.32||P-Value was from the non-parametric ANCOVA stratified by country|ANCOVA|Non-parametric|The median difference was calculated using Hodges-Lehmann point estimates and corresponding 95% confidence interval was constructed using the method of Moses.|Baseline to 16 Weeks||10.32|-17.50|0.6523
72508064|NCT00570739|144547545|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-4.38||||0.3934|TWO_SIDED|95.0|-17.51|8.77||P-Value was from the non-parametric ANCOVA stratified by country|ANCOVA|Non-parametric|The median difference was calculated using Hodges-Lehmann point estimates and corresponding 95% confidence interval was constructed using the method of Moses.|Baseline to 16 Weeks LOCF||8.77|-17.51|0.3934
72508065|NCT00570739|144547546|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.09||||0.9838|TWO_SIDED|95.0|-8.66|8.84||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Total VLDL Particles||8.84|-8.66|0.9838
72508066|NCT00570739|144547546|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.53||||0.7157|TWO_SIDED|95.0|-6.73|9.79||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Total VLDL Particles||9.79|-6.73|0.7157
72508067|NCT00570739|144547546|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.44|||<|0.0001|TWO_SIDED|95.0|1.25|3.63||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Large VLDL Chylomicron Particles||3.63|1.25|<0.0001
72508068|NCT00570739|144547546|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.39|||<|0.0001|TWO_SIDED|95.0|1.27|3.51||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Large VLDL Chylomicron Particles||3.51|1.27|<0.0001
72508069|NCT00570739|144547546|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.04||||0.0577|TWO_SIDED|95.0|-0.17|10.24||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Medium VLDL Chylomicron Particles||10.24|-0.17|0.0577
72508070|NCT00570739|144547546|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.24||||0.039|TWO_SIDED|95.0|0.27|10.22||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Medium VLDL Chylomicron Particles||10.22|0.27|0.0390
72508071|NCT00570739|144547546|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.49||||0.0044|TWO_SIDED|95.0|-12.61|-2.37||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Small VLDL Particles||-2.37|-12.61|0.0044
72508072|NCT00570739|144547546|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.24||||0.0118|TWO_SIDED|95.0|-11.09|-1.4||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Small VLDL Particles||-1.40|-11.09|0.0118
72508073|NCT00570739|144547546|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-110.6||||0.0293|TWO_SIDED|95.0|-209.9|-11.3||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Total Low Density Lipoprotein (LDL) Particles||-11.3|-209.9|0.0293
72508074|NCT00570739|144547546|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-112.7||||0.0202|TWO_SIDED|95.0|-207.6|-17.8||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Total Low Density Lipoprotein (LDL) Particles||-17.8|-207.6|0.0202
72508075|NCT00570739|144547546|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4||||0.9629|TWO_SIDED|95.0|-15.2|14.5|||ANCOVA|||Intermediate Density Lipoprotein (LDL) Particles||14.5|-15.2|0.9629
72576830|NCT00261443|144680657|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.23||||0.06|TWO_SIDED|95.0|-0.48|0.01||Baseline: ANOVA model, controlling for treatment, mood stabilizer, and index mood episode. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 48 Comparison||0.01|-0.48|0.060
72508076|NCT00570739|144547546|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.3||||0.7485|TWO_SIDED|95.0|-16.5|11.9||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Intermediate Density Lipoprotein (LDL) Particles||11.9|-16.5|0.7485
72508077|NCT00570739|144547546|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-63.6||||0.1007|TWO_SIDED|95.0|-139.7|12.5||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Large LDL Particles||12.5|-139.7|0.1007
72508078|NCT00570739|144547546|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-63.8||||0.0768|TWO_SIDED|95.0|-134.6|6.9||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Large LDL Particles||6.9|-134.6|0.0768
72508079|NCT00570739|144547546|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-47.7||||0.4143|TWO_SIDED|95.0|-162.7|67.3||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Small LDL Particles||67.3|-162.7|0.4143
72566298|NCT02697773|144663258|SUPERIORITY||Least Square Mean Difference|-0.78|STANDARD_ERROR_OF_MEAN|0.24||0.0012|TWO_SIDED|95.0|-1.25|-0.31|||ANCOVA|||Week 12: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain subscale and baseline diary average pain as covariate, and study site as a random effect.||-0.31|-1.25|0.0012
72508080|NCT00570739|144547546|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-46.9||||0.402|TWO_SIDED|95.0|-157.1|63.3||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Small LDL Particles||63.3|-157.1|0.4020
72508081|NCT00570739|144547546|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.6||||0.6378|TWO_SIDED|95.0|-29.1|17.9||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Medium Small LDL Particles||17.9|-29.1|0.6378
72508082|NCT00570739|144547546|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.7||||0.5528|TWO_SIDED|95.0|-29.1|15.6||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Medium Small LDL Particles||15.6|-29.1|0.5528
72508083|NCT00570739|144547546|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-42.0||||0.373|TWO_SIDED|95.0|-134.8|50.8||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Very Small LDL Particles||50.8|-134.8|0.3730
72566299|NCT02697773|144663258|SUPERIORITY||Least Square Mean Difference|-0.86|STANDARD_ERROR_OF_MEAN|0.24||0.0004|TWO_SIDED|95.0|-1.33|-0.38|||ANCOVA|||Week 12: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain subscale and baseline diary average pain as covariate, and study site as a random effect.||-0.38|-1.33|0.0004
72623226|NCT05796245|144777086|OTHER|Estimation|Risk Difference (RD)|0.01|||||TWO_SIDED|95.0|-0.12|0.03|||||Risk Difference (Exposed-Reference), where Exposed is Infliximab-Pfizer Biosimilar and Reference is Remicade.|Comparative analysis set, IPTW weighted||0.03|-0.12|
72623227|NCT05796245|144777086|OTHER|Estimation|Cox Proportional Hazard|2.61|||||TWO_SIDED|95.0|0.15|45.68|||||Hazard Ratio of Exposed/Reference, where Exposed is Infliximab-Pfizer Biosimilar and Reference is Remicade.|Comparative matched analysis set||45.68|0.15|
72623228|NCT05796245|144777086|OTHER|Estimation|Risk Ratio (RR)|2.01|||||TWO_SIDED|95.0|0.12|34.94|||||Risk Ratio of Exposed/Reference, where Exposed is Infliximab-Pfizer Biosimilar and Reference is Remicade.|Comparative matched analysis set||34.94|0.12|
72623229|NCT05796245|144777086|OTHER|Estimation|Risk Difference (RD)|0.02|||||TWO_SIDED|95.0|-0.1|0.26|||||Risk Difference (Exposed-Reference), where Exposed is Infliximab-Pfizer Biosimilar and Reference is Remicade.|Comparative matched analysis set||0.26|-0.10|
72623230|NCT05796245|144777086|OTHER|Estimation|Cox Proportional Hazard|2.7|||||TWO_SIDED|95.0|0.37|19.93|||||Crude Hazard Ratio Exposed/Reference, where Exposed is Infliximab-Pfizer Biosimilar and Reference is Remicade.|Comparative analysis set||19.93|0.37|
72623231|NCT05796245|144777086|OTHER|Estimation|Risk Ratio (RR)|2.66|||||TWO_SIDED|95.0|0.37|19.31|||||Crude Risk Ratio Exposed/Reference, where Exposed is Infliximab-Pfizer Biosimilar and Reference is Remicade.|Comparative analysis set||19.31|0.37|
72623232|NCT05796245|144777086|OTHER|Estimation|Risk Difference (RD)|0.02|||||TWO_SIDED|95.0|-0.05|0.1|||||Crude Risk Difference (Exposed-Reference), where Exposed is Infliximab-Pfizer Biosimilar and Reference is Remicade.|Comparative analysis set||0.10|-0.05|
72623233|NCT05796245|144777087|OTHER|Estimation|Cox Proportional Hazard|0.18|||||TWO_SIDED|95.0|0.02|1.85|||||Hazard Ratio of Exposed/Reference, where Exposed is Infliximab-Pfizer Biosimilar and Reference is Remicade.|Comparative analysis set, IPTW weighted||1.85|0.02|
72623234|NCT05796245|144777087|OTHER|Estimation|Risk Ratio (RR)|0.19|||||TWO_SIDED|95.0|0.02|1.99|||||Risk Ratio of Exposed/Reference, where Exposed is Infliximab-Pfizer Biosimilar and Reference is Remicade.|Comparative analysis set, IPTW weighted||1.99|0.02|
72623235|NCT05796245|144777087|OTHER|Estimation|Risk Difference (RD)|-0.01|||||TWO_SIDED|95.0|-0.17|0.0|||||Risk Difference (Exposed-Reference), where Exposed is Infliximab-Pfizer Biosimilar and Reference is Remicade.|Comparative analysis set, IPTW weighted||0.00|-0.17|
72623236|NCT05796245|144777087|OTHER|Estimation|Cox Proportional Hazard|0.63|||||TWO_SIDED|95.0|0.07|6.0|||||Hazard Ratio of Exposed/Reference, where Exposed is Infliximab-Pfizer Biosimilar and Reference is Remicade.|Comparative matched analysis set||6.00|0.07|
72623237|NCT05796245|144777087|OTHER|Estimation|Risk Ratio (RR)|0.71|||||TWO_SIDED|95.0|0.08|6.61|||||Risk Ratio of Exposed/Reference, where Exposed is Infliximab-Pfizer Biosimilar and Reference is Remicade.|Comparative matched analysis set||6.61|0.08|
72623238|NCT05796245|144777087|OTHER|Estimation|Risk Difference (RD)|-0.01|||||TWO_SIDED|95.0|-0.1|0.21|||||Risk Difference (Exposed-Reference), where Exposed is Infliximab-Pfizer Biosimilar and Reference is Remicade.|Comparative matched analysis set||0.21|-0.10|
72623239|NCT05796245|144777087|OTHER|Estimation|Cox Proportional Hazard|2.07|||||TWO_SIDED|95.0|0.28|15.22|||||Crude Hazard Ratio Exposed/Reference, where Exposed is Infliximab-Pfizer Biosimilar and Reference is Remicade.|Comparative analysis set||15.22|0.28|
72508084|NCT00570739|144547546|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-40.0||||0.3764|TWO_SIDED|95.0|-129.0|49.0||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Very Small LDL Particles||49.0|-129.0|0.3764
72508085|NCT00570739|144547546|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01||||0.9807|TWO_SIDED|95.0|-1.2|1.17||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Total High Density Lipoprotein (HDL) Particles||1.17|-1.20|0.9807
72476179|NCT01302067|144478201|SUPERIORITY_OR_OTHER|||||||0.0348|TWO_SIDED|||||A closed-testing procedure was used for the treatment comparison.|ANCOVA|Testing for percent change from baseline was only carried out for given endpoint if corresponding numeric change result was statistically significant.||P-value was based on a RANKED ANCOVA model with terms for treatment and pooled country with ranked baseline value as a covariate.||||0.0348
72476180|NCT01302067|144478201|SUPERIORITY_OR_OTHER|||||||0.0003|TWO_SIDED|||||A closed-testing procedure was used for the treatment comparison.|ANCOVA|Testing for percent change from baseline was only carried out for given endpoint if corresponding numeric change result was statistically significant.||P-value was based on a RANKED ANCOVA model with terms for treatment and pooled country with ranked baseline value as a covariate.||||0.0003
72476181|NCT01302067|144478202|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||A closed-testing procedure was used for the treatment comparison.|ANCOVA|Testing for percent change from baseline was only carried out for given endpoint if corresponding numeric change result was statistically significant.||P-value was based on a RANKED ANCOVA model with terms for treatment and pooled country with ranked baseline value as a covariate.||||<0.0001
72476182|NCT01302067|144478202|SUPERIORITY_OR_OTHER|||||||0.0002|TWO_SIDED|||||A closed-testing procedure was used for the treatment comparison.|ANCOVA|Testing for percent change from baseline was only carried out for given endpoint if corresponding numeric change result was statistically significant.||P-value was based on a RANKED ANCOVA model with terms for treatment and pooled country with ranked baseline value as a covariate.||||0.0002
72476183|NCT01302067|144478202|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||A closed-testing procedure was used for the treatment comparison.|ANCOVA|Testing for percent change from baseline was only carried out for given endpoint if corresponding numeric change result was statistically significant.||P-value was based on a RANKED ANCOVA model with terms for treatment and pooled country with ranked baseline value as a covariate.||||<0.0001
72476184|NCT01302067|144478203|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||A closed-testing procedure was used for the treatment comparison.|Cochran-Mantel-Haenszel|||Change at Week 12- deterioration, no change, minor improvement and major improvement: Cochran-Mantel-Haenszel (CMH) test with modified ridit scoring controlling for country was used to calculate p-value.||||<0.0001
72476185|NCT01302067|144478203|SUPERIORITY_OR_OTHER|||||||0.0057|TWO_SIDED|||||A closed-testing procedure was used for the treatment comparison.|Cochran-Mantel-Haenszel|||Change at Week 12- deterioration, no change, minor improvement and major improvement: Cochran-Mantel-Haenszel (CMH) test with modified ridit scoring controlling for country was used to calculate p-value.||||0.0057
72476186|NCT01302067|144478203|SUPERIORITY_OR_OTHER|||||||0.0008|TWO_SIDED|||||A closed-testing procedure was used for the treatment comparison.|Cochran-Mantel-Haenszel|||Change at Week 12- deterioration, no change, minor improvement and major improvement: Cochran-Mantel-Haenszel (CMH) test with modified ridit scoring controlling for country was used to calculate p-value.||||0.0008
72476187|NCT01302067|144478204|SUPERIORITY_OR_OTHER|||||||0.0007|TWO_SIDED|||||A closed-testing procedure was used for the treatment comparison.|Cochran-Mantel-Haenszel|||Change at Week 12- deterioration, no change, minor improvement and major improvement: Cochran-Mantel-Haenszel (CMH) test with modified ridit scoring controlling for country was used to calculate p-value.||||0.0007
72476188|NCT01302067|144478204|SUPERIORITY_OR_OTHER|||||||0.0091|TWO_SIDED|||||A closed-testing procedure was used for the treatment comparison.|Cochran-Mantel-Haenszel|||Change at Week 12- deterioration, no change, minor improvement and major improvement: Cochran-Mantel-Haenszel (CMH) test with modified ridit scoring controlling for country was used to calculate p-value.||||0.0091
72476189|NCT01302067|144478204|SUPERIORITY_OR_OTHER|||||||0.3901|TWO_SIDED|||||A closed-testing procedure was used for the treatment comparison.|Cochran-Mantel-Haenszel|||Change at Week 12- deterioration, no change, minor improvement and major improvement: Cochran-Mantel-Haenszel (CMH) test with modified ridit scoring controlling for country was used to calculate p-value.||||0.3901
72566300|NCT02697773|144663260|SUPERIORITY||Least Mean Square Difference|-0.75|STANDARD_ERROR_OF_MEAN|0.21||0.0004|TWO_SIDED|95.0|-1.17|-0.34|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariate, and study site as a random effect.||-0.34|-1.17|0.0004
72566301|NCT02697773|144663260|SUPERIORITY||Least Square Mean Difference|-0.91|STANDARD_ERROR_OF_MEAN|0.21|<|0.0001|TWO_SIDED|95.0|-1.33|-0.5|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariate, and study site as a random effect.||-0.50|-1.33|<.0001
72566302|NCT02697773|144663260|SUPERIORITY||Least Square Mean Difference|-1.02|STANDARD_ERROR_OF_MEAN|0.22|<|0.0001|TWO_SIDED|95.0|-1.45|-0.6|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariate, and study site as a random effect.||-0.60|-1.45|<.0001
72623240|NCT05796245|144777087|OTHER|Estimation|Risk Ratio (RR)|2.1|||||TWO_SIDED|95.0|0.29|15.08|||||Crude Risk Ratio of Exposed/Reference, where Exposed is Infliximab-Pfizer Biosimilar and Reference is Remicade.|Comparative analysis set||15.08|0.29|
72476190|NCT01302067|144478205|SUPERIORITY_OR_OTHER||Least squares mean difference|-12.47|STANDARD_ERROR_OF_MEAN|1.54|<|0.0001|TWO_SIDED|95.0|-15.49|-9.45||A closed-testing procedure was used for the treatment comparison.|ANCOVA||Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.|Change at Week 12- ANCOVA model with terms for treatment, pooled country, centered baseline value and centered baseline by treatment interaction was used to calculate p-value.||-9.45|-15.49|<0.0001
72623241|NCT05796245|144777087|OTHER|Estimation|Risk Difference (RD)|0.02|||||TWO_SIDED|95.0|-0.05|0.09|||||Crude Risk Difference (Exposed-Reference), where Exposed is Infliximab-Pfizer Biosimilar and Reference is Remicade.|Comparative analysis set||0.09|-0.05|
72476191|NCT01302067|144478205|SUPERIORITY_OR_OTHER||Least squares mean difference|-4.69|STANDARD_ERROR_OF_MEAN|1.26||0.0002|TWO_SIDED|95.0|-7.15|-2.22||A closed-testing procedure was used for the treatment comparison.|ANCOVA||Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.|Change at Week 12- ANCOVA model with terms for treatment, pooled country, centered baseline value and centered baseline by treatment interaction was used to calculate p-value.||-2.22|-7.15|0.0002
72476192|NCT01302067|144478205|SUPERIORITY_OR_OTHER||Least squares mean difference|-7.78|STANDARD_ERROR_OF_MEAN|1.53|<|0.0001|TWO_SIDED|95.0|-10.78|-4.78||A closed-testing procedure was used for the treatment comparison.|ANCOVA||Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.|Change at Week 12- ANCOVA model with terms for treatment, pooled country, centered baseline value and centered baseline by treatment interaction was used to calculate p-value.||-4.78|-10.78|<0.0001
72476193|NCT01302067|144478206|SUPERIORITY_OR_OTHER||Least squares mean difference|10.46|STANDARD_ERROR_OF_MEAN|1.67|<|0.0001|TWO_SIDED|95.0|7.2|13.73||A closed-testing procedure was used for the treatment comparison.|ANCOVA||Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.|P-value was based on an ANCOVA model with terms for treatment, pooled country, centered baseline value and centered baseline by treatment interaction.||13.73|7.20|<0.0001
72476194|NCT01302067|144478206|SUPERIORITY_OR_OTHER||Least squares mean difference|4.68|STANDARD_ERROR_OF_MEAN|1.36||0.0006|TWO_SIDED|95.0|2.01|7.36||A closed-testing procedure was used for the treatment comparison.|ANCOVA||Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.|P-value was based on an ANCOVA model with terms for treatment, pooled country, centered baseline value and centered baseline by treatment interaction.||7.36|2.01|0.0006
72508086|NCT00570739|144547546|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.8615|TWO_SIDED|95.0|-1.23|1.03||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Total High Density Lipoprotein (HDL) Particles||1.03|-1.23|0.8615
72508087|NCT00570739|144547546|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.59||||0.0364|TWO_SIDED|95.0|0.04|1.14||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Large HDL Particles||1.14|0.04|0.0364
72508088|NCT00570739|144547546|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.56||||0.034|TWO_SIDED|95.0|0.04|1.08||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Large HDL Particles||1.08|0.04|0.0340
72508089|NCT00570739|144547546|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2||||0.6587|TWO_SIDED|95.0|-0.68|1.07||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Medium HDL Particles||1.07|-0.68|0.6587
72508090|NCT00570739|144547546|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.19||||0.6554|TWO_SIDED|95.0|-0.63|1.0||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Medium HDL Particles||1.00|-0.63|0.6554
72508091|NCT00570739|144547546|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.82||||0.1957|TWO_SIDED|95.0|-2.06|0.42||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Small HDL Particles||0.42|-2.06|0.1957
72508092|NCT00570739|144547546|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.85||||0.1622|TWO_SIDED|95.0|-2.03|0.34||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Small HDL Particles||0.34|-2.03|0.1622
72508093|NCT00570739|144547547|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.99|||<|0.0001|TWO_SIDED|95.0|3.51|8.48||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Very Low Density Lipoprotein Particles||8.48|3.51|<0.0001
72508094|NCT00570739|144547547|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.31|||<|0.0001|TWO_SIDED|95.0|3.0|7.63||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Very Low Density Lipoprotein Particles||7.63|3.00|<0.0001
72508095|NCT00570739|144547547|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.12||||0.1742|TWO_SIDED|95.0|-0.3|0.05||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Low Density Lipoprotein Particles||0.05|-0.30|0.1742
72508096|NCT00570739|144547547|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.11||||0.187|TWO_SIDED|95.0|-0.28|0.06|||ANCOVA|||Low Density Lipoprotein Particles||0.06|-0.28|0.1870
72508097|NCT00570739|144547547|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.09||||0.0063|TWO_SIDED|95.0|0.03|0.16||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||High Density Lipoprotein Particles||0.16|0.03|0.0063
72508098|NCT00570739|144547547|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||0.002|TWO_SIDED|95.0|0.04|0.16||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||High Density Lipoprotein Particles||0.16|0.04|0.0020
72508099|NCT00570739|144547548|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|24.4||||0.0022|TWO_SIDED|95.0|8.9|39.9||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Changes in Calculated Total Triglycerides||39.9|8.9|0.0022
72508100|NCT00570739|144547548|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|24.3||||0.0013|TWO_SIDED|95.0|9.6|39.1||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Changes in Calculated Total Triglycerides||39.1|9.6|0.0013
72508101|NCT00570739|144547548|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|26.3||||0.0006|TWO_SIDED|95.0|11.5|41.0||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Changes: Calculated Very Low Density Triglycerides||41.0|11.5|0.0006
72508102|NCT00570739|144547548|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|26.5||||0.0003|TWO_SIDED|95.0|12.5|40.6||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Changes: Calculated Very Low Density Triglycerides||40.6|12.5|0.0003
72508103|NCT00570739|144547548|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.5||||0.1257|TWO_SIDED|95.0|-0.4|3.5||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Changes in Calculated High Density Lipoprotein-Cholesterol||3.5|-0.4|0.1257
72508104|NCT00570739|144547548|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.5||||0.1054|TWO_SIDED|95.0|-0.3|3.3||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Changes in Calculated High Density Lipoprotein-Cholesterol||3.3|-0.3|0.1054
72508105|NCT00570739|144547549|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.04||||0.2971|TWO_SIDED|95.0|-0.11|0.03||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 4 Weeks||0.03|-0.11|0.2971
72508106|NCT00570739|144547549|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.04||||0.2567|TWO_SIDED|95.0|-0.11|0.03||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 8 Weeks||0.03|-0.11|0.2567
72623242|NCT04999267|144777088|OTHER|Pre-intervention vs. Post-intervention analysis|||||<|0.0001|||||||Chi-squared|||||||<0.0001
72623243|NCT04999267|144777089|OTHER|Pre-intervention vs. Post-intervention analysis|||||<|0.0001|||||||Chi-squared|||||||<.0001
72476195|NCT01302067|144478206|SUPERIORITY_OR_OTHER||Least squares mean difference|5.78|STANDARD_ERROR_OF_MEAN|1.66||0.0005|TWO_SIDED|95.0|2.53|9.03||A closed-testing procedure was used for the treatment comparison.|ANCOVA||Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.|P-value was based on an ANCOVA model with terms for treatment, pooled country, centered baseline value and centered baseline by treatment interaction.||9.03|2.53|0.0005
72476196|NCT01302067|144478207|SUPERIORITY_OR_OTHER||Least squares mean difference|10.91|STANDARD_ERROR_OF_MEAN|1.62|<|0.0001|TWO_SIDED|95.0|7.73|14.09||A closed-testing procedure was used for the treatment comparison.|ANCOVA||Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.|P-value was based on an ANCOVA model with terms for treatment, pooled country, centered baseline value and centered baseline by treatment interaction.||14.09|7.73|<0.0001
72476197|NCT01302067|144478207|SUPERIORITY_OR_OTHER||Least squares mean difference|4.36|STANDARD_ERROR_OF_MEAN|1.33||0.001|TWO_SIDED|95.0|1.76|6.96||A closed-testing procedure was used for the treatment comparison.|ANCOVA||Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.|P-value was based on an ANCOVA model with terms for treatment, pooled country, centered baseline value and centered baseline by treatment interaction.||6.96|1.76|0.0010
72476198|NCT01302067|144478207|SUPERIORITY_OR_OTHER||Least squares mean difference|6.55|STANDARD_ERROR_OF_MEAN|1.61|<|0.0001|TWO_SIDED|95.0|3.39|9.72||A closed-testing procedure was used for the treatment comparison.|ANCOVA||Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.|P-value was based on an ANCOVA model with terms for treatment, pooled country, centered baseline value and centered baseline by treatment interaction.||9.72|3.39|<0.0001
72476199|NCT01302067|144478208|SUPERIORITY_OR_OTHER||Least squares mean difference|7.46|STANDARD_ERROR_OF_MEAN|1.56|<|0.0001|TWO_SIDED|95.0|4.4|10.51||A closed-testing procedure was used for the treatment comparison.|ANCOVA||Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.|P-value was based on an ANCOVA model with terms for treatment, pooled country, centered baseline value and centered baseline by treatment interaction.||10.51|4.40|<0.0001
72566303|NCT02697773|144663260|SUPERIORITY||Least Square Mean Difference|-1.11|STANDARD_ERROR_OF_MEAN|0.22|<|0.0001|TWO_SIDED|95.0|-1.53|-0.68|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariate, and study site as a random effect.||-0.68|-1.53|<.0001
72566304|NCT02697773|144663260|SUPERIORITY||Least Square Mean Difference|-0.63|STANDARD_ERROR_OF_MEAN|0.23||0.0057|TWO_SIDED|95.0|-1.07|-0.18|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariate, and study site as a random effect.||-0.18|-1.07|0.0057
72476200|NCT01302067|144478208|SUPERIORITY_OR_OTHER||Least squares mean difference|3.74|STANDARD_ERROR_OF_MEAN|1.27||0.0034|TWO_SIDED|95.0|1.24|6.23||A closed-testing procedure was used for the treatment comparison.|ANCOVA||Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.|P-value was based on an ANCOVA model with terms for treatment, pooled country, centered baseline value and centered baseline by treatment interaction.||6.23|1.24|0.0034
72476201|NCT01302067|144478208|SUPERIORITY_OR_OTHER||Least squares mean difference|3.72|STANDARD_ERROR_OF_MEAN|1.55||0.0164|TWO_SIDED|95.0|0.68|6.76||A closed-testing procedure was used for the treatment comparison.|ANCOVA||Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.|P-value was based on an ANCOVA model with terms for treatment, pooled country, centered baseline value and centered baseline by treatment interaction.||6.76|0.68|0.0164
72476202|NCT01302067|144478209|SUPERIORITY_OR_OTHER||Least squares mean difference|7.5|STANDARD_ERROR_OF_MEAN|1.26|<|0.0001|TWO_SIDED|95.0|5.03|9.97||A closed-testing procedure was used for the treatment comparison.|ANCOVA||Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.|P-value was based on an ANCOVA model with terms for treatment, pooled country, centered baseline value and centered baseline by treatment interaction.||9.97|5.03|<0.0001
72476203|NCT01302067|144478209|SUPERIORITY_OR_OTHER||Least squares mean difference|3.68|STANDARD_ERROR_OF_MEAN|1.03||0.0004|TWO_SIDED|95.0|1.65|5.7||A closed-testing procedure was used for the treatment comparison.|ANCOVA||Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.|P-value was based on an ANCOVA model with terms for treatment, pooled country, centered baseline value and centered baseline by treatment interaction.||5.70|1.65|0.0004
72476204|NCT01302067|144478209|SUPERIORITY_OR_OTHER||Least squares mean difference|3.82|STANDARD_ERROR_OF_MEAN|1.25||0.0023|TWO_SIDED|95.0|1.36|6.28||A closed-testing procedure was used for the treatment comparison.|ANCOVA||Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.|P-value was based on an ANCOVA model with terms for treatment, pooled country, centered baseline value and centered baseline by treatment interaction.||6.28|1.36|0.0023
72508107|NCT00570739|144547549|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.06||||0.1081|TWO_SIDED|95.0|-0.13|0.01||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 12 Weeks||0.01|-0.13|0.1081
72508108|NCT00570739|144547549|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.08||||0.079|TWO_SIDED|95.0|-0.17|0.01||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks||0.01|-0.17|0.0790
72508109|NCT00570739|144547549|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.0206|TWO_SIDED|95.0|-0.18|-0.01||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks LOCF||-0.01|-0.18|0.0206
72508110|NCT00570739|144547550|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.3||||0.0009|TWO_SIDED|95.0|-6.8|-1.8||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 4 Weeks||-1.8|-6.8|0.0009
72476205|NCT01302067|144478210|SUPERIORITY_OR_OTHER||Least squares mean difference|9.37|STANDARD_ERROR_OF_MEAN|1.43|<|0.0001|TWO_SIDED|95.0|6.56|12.18||A closed-testing procedure was used for the treatment comparison.|ANCOVA||Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.|P-value was based on an ANCOVA model with terms for treatment, pooled country, centered baseline value and centered baseline by treatment interaction.||12.18|6.56|<0.0001
72476206|NCT01302067|144478210|SUPERIORITY_OR_OTHER||Least squares mean difference|4.23|STANDARD_ERROR_OF_MEAN|1.17||0.0003|TWO_SIDED|95.0|1.93|6.53||A closed-testing procedure was used for the treatment comparison.|ANCOVA||Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.|P-value was based on an ANCOVA model with terms for treatment, pooled country, centered baseline value and centered baseline by treatment interaction.||6.53|1.93|0.0003
72476207|NCT01302067|144478210|SUPERIORITY_OR_OTHER||Least squares mean difference|5.14|STANDARD_ERROR_OF_MEAN|1.43||0.0003|TWO_SIDED|95.0|2.34|7.94||A closed-testing procedure was used for the treatment comparison.|ANCOVA||Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.|P-value was based on an ANCOVA model with terms for treatment, pooled country, centered baseline value and centered baseline by treatment interaction.||7.94|2.34|0.0003
72508111|NCT00570739|144547550|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.0||||0.1184|TWO_SIDED|95.0|-4.5|0.5||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 8 Weeks||0.5|-4.5|0.1184
72508112|NCT00570739|144547550|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.8||||0.0615|TWO_SIDED|95.0|-5.8|0.1||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 12 Weeks||0.1|-5.8|0.0615
72508113|NCT00570739|144547550|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.3||||0.3617|TWO_SIDED|95.0|-7.2|2.6||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks||2.6|-7.2|0.3617
72508114|NCT00570739|144547550|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.6||||0.2372|TWO_SIDED|95.0|-7.0|1.7||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks LOCF||1.7|-7.0|0.2372
72508115|NCT00570739|144547551|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.921||||0.2982|TWO_SIDED|95.0|-0.821|2.663||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 4 Weeks||2.663|-0.821|0.2982
72566305|NCT02697773|144663260|SUPERIORITY||Least Square Mean Difference|-0.57|STANDARD_ERROR_OF_MEAN|0.23||0.0114|TWO_SIDED|95.0|-1.02|-0.13|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariate, and study site as a random effect.||-0.13|-1.02|0.0114
72476208|NCT01302067|144478211|SUPERIORITY_OR_OTHER|||||||0.0016|TWO_SIDED|||||A closed-testing procedure was used for the treatment comparison.|Cochran-Mantel-Haenszel|||P-value was obtained from a Cochran-Mantel-Haenszel (CMH) general association test stratified by country.||||0.0016
72476209|NCT01302067|144478211|SUPERIORITY_OR_OTHER|||||||0.8121|TWO_SIDED|||||A closed-testing procedure was used for the treatment comparison.|Cochran-Mantel-Haenszel|||P-value was obtained from a Cochran-Mantel-Haenszel (CMH) general association test stratified by country.||||0.8121
72476210|NCT01302067|144478211|SUPERIORITY_OR_OTHER|||||||0.0015|TWO_SIDED|||||A closed-testing procedure was used for the treatment comparison.|Cochran-Mantel-Haenszel|||P-value was obtained from a Cochran-Mantel-Haenszel (CMH) general association test stratified by country.||||0.0015
72476211|NCT01302067|144478212|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||A closed-testing procedure was used for the treatment comparison.|Cochran-Mantel-Haenszel|||P-value was obtained from a Cochran-Mantel-Haenszel (CMH) general association test stratified by country.||||<0.0001
72476212|NCT01302067|144478212|SUPERIORITY_OR_OTHER|||||||0.0006|TWO_SIDED|||||A closed-testing procedure was used for the treatment comparison.|Cochran-Mantel-Haenszel|||P-value was obtained from a Cochran-Mantel-Haenszel (CMH) general association test stratified by country.||||0.0006
72508116|NCT00570739|144547551|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.695||||0.2361|TWO_SIDED|95.0|-0.458|1.848||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 8 Weeks||1.848|-0.458|0.2361
72508117|NCT00570739|144547551|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.218||||0.0413|TWO_SIDED|95.0|-2.388|-0.049|||ANCOVA|||Baseline to 12 Weeks||-0.049|-2.388|0.0413
72508118|NCT00570739|144547551|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.434||||0.7858|TWO_SIDED|95.0|-3.583|2.715|||ANCOVA|||Baseline to 16 Weeks||2.715|-3.583|0.7858
72476213|NCT01302067|144478212|SUPERIORITY_OR_OTHER|||||||0.0027|TWO_SIDED|||||A closed-testing procedure was used for the treatment comparison.|Cochran-Mantel-Haenszel|||P-value was obtained from a Cochran-Mantel-Haenszel (CMH) general association test stratified by country.||||0.0027
72476214|NCT02704754|144478230|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|||||||<.05
72476215|NCT03809429|144478240|OTHER||Difference|1.31||||0.0185|TWO_SIDED|95.0|0.22|2.4|||Negative binomial regression|Negative binomial regression model with treatment, age strata, and AMH group as factors.||||2.40|0.22|0.0185
72476216|NCT03809429|144478243|OTHER||Difference|1.14||||0.0281|TWO_SIDED|95.0|0.12|2.15|||Negative binomial regression|Negative binomial regression model with treatment, age strata, and AMH group as factors.||\>=10 mm at end of stimulation||2.15|0.12|0.0281
72476217|NCT03809429|144478243|OTHER||Difference|0.99||||0.0258|TWO_SIDED|95.0|0.12|1.86|||Negative binomial regression|Negative binomial regression model with treatment, age strata, and AMH group as factors.||\>=12 mm at end of stimulation||1.86|0.12|0.0258
72476218|NCT03809429|144478243|OTHER||Difference|0.58||||0.0672|TWO_SIDED|95.0|-0.04|1.2|||Negative binomial regression|Negative binomial regression model with treatment, age strata, and AMH group as factors.||\>=15 mm at end of stimulation||1.20|-0.04|0.0672
72476219|NCT03809429|144478243|OTHER||Difference|0.21||||0.339|TWO_SIDED|95.0|-0.22|0.63|||Negative binomial regression|Negative binomial regression model with treatment, age strata, and AMH group as factors.||\>=17 mm at end of stimulation||0.63|-0.22|0.3390
72476220|NCT03809429|144478245|OTHER||Difference|1.11||||0.0962|TWO_SIDED|95.0|-0.2|2.41|||Negative binomial regression|Negative binomial regression model with treatment, age strata, and AMH group as factors.||||2.41|-0.20|0.0962
72476221|NCT03809429|144478247|OTHER||Difference|0.51||||0.1894|TWO_SIDED|95.0|-0.25|1.27|||Negative binomial regression|Negative binomial regression model with treatment, age strata, and AMH group as factors.||Number of embryos||1.27|-0.25|0.1894
72508119|NCT00570739|144547551|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.493||||0.7314|TWO_SIDED|95.0|-3.321|2.335|||ANCOVA|||Baseline to 16 Weeks LOCF||2.335|-3.321|0.7314
72508120|NCT00570739|144547552|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.089||||0.553|TWO_SIDED|95.0|-0.385|0.207||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks||0.207|-0.385|0.5530
72508121|NCT00570739|144547552|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.105||||0.4554|TWO_SIDED|95.0|-0.383|0.172||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks LOCF||0.172|-0.383|0.4554
72508122|NCT00570739|144547553|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9||||0.8583|TWO_SIDED|95.0|-10.7|8.9||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks||8.9|-10.7|0.8583
72508123|NCT00570739|144547553|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.2||||0.7975|TWO_SIDED|95.0|-10.5|8.1||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks LOCF||8.1|-10.5|0.7975
72508124|NCT00570739|144547554|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.0||||0.233||95.0|-18.5|4.5||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks||4.5|-18.5|0.2330
72508125|NCT00570739|144547554|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.2||||0.1412|TWO_SIDED|95.0|-19.2|2.8||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks LOCF||2.8|-19.2|0.1412
72508126|NCT00570739|144547555|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.4||||0.8192|TWO_SIDED|95.0|-13.7|10.8||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks||10.8|-13.7|0.8192
72508127|NCT00570739|144547555|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.9||||0.7513|TWO_SIDED|95.0|-13.5|9.7||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks LOCF||9.7|-13.5|0.7513
72508128|NCT00570739|144547556|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.91||||0.4301|TWO_SIDED|95.0|-24.156|10.336||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks||10.336|-24.156|0.4301
72508129|NCT00570739|144547556|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.17||||0.5369|TWO_SIDED|95.0|-21.661|11.321||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks LOCF||11.321|-21.661|0.5369
72508130|NCT00570739|144547557|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.151||||0.7447|TWO_SIDED|95.0|-1.068|0.765||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks||0.765|-1.068|0.7447
72508131|NCT00570739|144547557|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.029||||0.9476|TWO_SIDED|95.0|-0.853|0.911||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks LOCF||0.911|-0.853|0.9476
72508132|NCT00570739|144547558|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||P-Value for comparing percentages was from the Cochran-Mantel-Haenszel test stratified by country.|Cochran-Mantel-Haenszel|||Baseline to 8 Weeks||||<0.0001
72508133|NCT00570739|144547558|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.23||||0.0018|TWO_SIDED|95.0|2.06|13.58||P-Value for comparing percentages was from the Cochran-Mantel-Haenszel test stratified by country.|Cochran-Mantel-Haenszel|||Baseline to 16 Weeks||13.58|2.06|0.0018
72508134|NCT00570739|144547558|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.46||||0.0019|TWO_SIDED|95.0|1.89|10.54||P-Value for comparing percentages was from the Cochran-Mantel-Haenszel test stratified by country.|Cochran-Mantel-Haenszel|||Baseline to 16 Weeks LOCF||10.54|1.89|0.0019
72508135|NCT00570739|144547558|SUPERIORITY_OR_OTHER|||||||0.0005||95.0|||||Regression, Logistic|Contained treatment and country as factors and baseline lab value as a covariate||Baseline to 16 Weeks||||0.0005
72508136|NCT00570739|144547558|SUPERIORITY_OR_OTHER|||||||0.0007||95.0|||||Regression, Logistic|Contained treatment and country as factors and baseline lab value as a covariate||Baseline to 16 Weeks LOCF||||0.0007
72508137|NCT00570739|144547559|SUPERIORITY_OR_OTHER|||||||0.0104||95.0||||P-Value for comparing percentages was from the Cochran-Mantel-Haenszel test stratified by country.|Cochran-Mantel-Haenszel|||Baseline to 8 Weeks||||0.0104
72508138|NCT00570739|144547559|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.22||||0.2224|TWO_SIDED|95.0|0.53|9.39||P-Value for comparing percentages was from the Cochran-Mantel-Haenszel test stratified by country.|Cochran-Mantel-Haenszel|||Baseline to 16 Weeks||9.39|0.53|0.2224
72508139|NCT00570739|144547559|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.21||||0.199|TWO_SIDED|95.0|0.53|9.33||P-Value for comparing percentages was from the Cochran-Mantel-Haenszel test stratified by country.|Cochran-Mantel-Haenszel|||Baseline to 16 Weeks LOCF||9.33|0.53|0.1990
72508140|NCT00570739|144547559|SUPERIORITY_OR_OTHER|||||||0.2778||95.0|||||Regression, Logistic|Contained treatment and country as factors and baseline lab value as a covariate||Baseline to 16 Weeks||||0.2778
72508141|NCT00570739|144547559|SUPERIORITY_OR_OTHER|||||||0.2785||95.0|||||Regression, Logistic|Contained treatment and country as factors and baseline lab value as a covariate||Baseline to 16 Weeks LOCF||||0.2785
72508142|NCT00570739|144547560|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.68||||0.5353|TWO_SIDED|95.0|-2.84|1.48||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks||1.48|-2.84|0.5353
72508143|NCT00570739|144547560|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.62||||0.5475|TWO_SIDED|95.0|-2.64|1.4||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks LOCF||1.40|-2.64|0.5475
72508144|NCT00570739|144547561|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.0116||||0.0678|TWO_SIDED|95.0|-0.0241|0.0009||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks||0.0009|-0.0241|0.0678
72508145|NCT00570739|144547561|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.0112||||0.0585|TWO_SIDED|95.0|-0.0228|0.0004||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks LOCF||0.0004|-0.0228|0.0585
72476222|NCT03809429|144478247|OTHER||Difference|-0.03||||0.9361|TWO_SIDED|95.0|-0.68|0.63|||Negative binomial regression|Negative binomial regression model with treatment, age strata, and AMH group as factors.||Number of Good-quality embryos||0.63|-0.68|0.9361
72476223|NCT03809429|144478248|OTHER||Difference|0.37||||0.2025|TWO_SIDED|95.0|-0.2|0.94|||Negative binomial regression|Negative binomial regression model with treatment, age strata, and AMH group as factors.||Total number of blastocysts||0.94|-0.20|0.2025
72476224|NCT03809429|144478248|OTHER||Difference|0.12||||0.5946|TWO_SIDED|95.0|-0.31|0.54|||Negative binomial regression|Negative binomial regression model with treatment, age strata, and AMH group as factors.||Number of good-quality blastocysts||0.54|-0.31|0.5946
72476225|NCT03809429|144478254|OTHER||Difference|16.94|||<|0.0001|TWO_SIDED|95.0|12.13|21.74|||ANOVA|ANOVA model with treatment, age strata, and AMH group as factors.||||21.74|12.13|<0.0001
72476226|NCT03809429|144478255|OTHER||Difference|1.56|||<|0.0001|TWO_SIDED|95.0|1.19|1.92|||ANOVA|ANOVA model with treatment, age strata, and AMH group as factors.||||1.92|1.19|<0.0001
72476227|NCT03809429|144478256|OTHER||Difference|6.99||||0.1579|TWO_SIDED|95.0|-2.71|16.7|||Regression, Logistic|Logistic regression model with treatment, age strata, and AMH group as factors.||||16.70|-2.71|0.1579
72476228|NCT03809429|144478258|OTHER||Difference|7.66||||0.1134|TWO_SIDED|95.0|-1.82|17.14|||Regression, Logistic|Logistic regression model with treatment, age strata, and AMH group as factors.||||17.14|-1.82|0.1134
72476229|NCT03809429|144478259|OTHER||Difference|8.81||||0.0642|TWO_SIDED|95.0|-0.52|18.14|||Regression, Logistic|Logistic regression model with treatment, age strata, and AMH group as factors.||||18.14|-0.52|0.0642
72476230|NCT03809429|144478260|OTHER||Difference|7.74||||0.1002|TWO_SIDED|95.0|-1.49|16.97|||Regression, Logistic|Logistic regression model with treatment, age strata, and AMH group as factors.||||16.97|-1.49|0.1002
72476231|NCT03507777|144478292|SUPERIORITY||||||<|0.0001|||||||Linear mixed model|||||||<0.0001
72476232|NCT03507777|144478293|SUPERIORITY|||||||0.2487|||||||A Cox regression model|||||||0.2487
72476233|NCT03507777|144478294|SUPERIORITY|||||||0.2952|||||||A Cox regression model|||||||0.2952
72476234|NCT00006011|144478297|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.9|||||TWO_SIDED|95.0|0.69|1.17||||||"Primary outcome is measured as a treatment hazard ratio stratified by stage and assuming proportional hazards.~Recurrence-free survival hazard ratio: Arm 2 is relative to Arm 1."||1.17|0.69|
72476235|NCT00774930|144478313|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0165|TWO_SIDED||||||ANCOVA|This analysis does not include any imputation for the early roll over subjects||||||0.0165
72476236|NCT00774930|144478314|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2544|||||||ANCOVA|ANCOVA included treatment group and 2 stratification variables at randomisation as factors and average frequency of diarrhoea per day during Screening||||||0.2544
72476237|NCT01498679|144478382|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|51.0|||<|0.001|TWO_SIDED|95.0|42.2|59.7|||ANCOVA|||||59.7|42.2|<0.001
72476238|NCT00548262|144478429|SUPERIORITY_OR_OTHER||percentage of participants with success|59.1|||||TWO_SIDED|95.0|44.6|73.6|||||95% CI based on normal approximation to the binomial.|Success at EOT||73.6|44.6|
72476239|NCT00548262|144478430|SUPERIORITY_OR_OTHER||percentage of participants with success|59.1|||||TWO_SIDED|95.0|44.6|73.6|||||95% CI based on normal approximation to the binomial.|EIVT Success||73.6|44.6|
72476240|NCT00548262|144478430|SUPERIORITY_OR_OTHER||percentage of participants with success|47.7|||||TWO_SIDED|95.0|33.0|62.5|||||95% CI based on normal approximation to the binomial.|Week 2 Follow-up Success||62.5|33.0|
72476241|NCT00548262|144478431|SUPERIORITY_OR_OTHER||percentage of participants with success|52.4|||||TWO_SIDED|95.0|31.0|73.7|||||95% CI based on normal approximation to the binomial.|Candida albicans: Success||73.7|31.0|
72476242|NCT00548262|144478431|SUPERIORITY_OR_OTHER||percentage of participants with success|50.0|||||TWO_SIDED|95.0|0.0|100.0|||||95% CI based on normal approximation to the binomial.|Candida famata: Success||100.0|0.0|
72476243|NCT00548262|144478431|SUPERIORITY_OR_OTHER||percentage of participants with success|66.7|||||TWO_SIDED|95.0|13.3|100.0|||||95% CI based on normal approximation to the binomial.|Candida glabrata: Success||100.0|13.3|
72476244|NCT00548262|144478431|SUPERIORITY_OR_OTHER||percentage of participants with success|66.7|||||TWO_SIDED|95.0|13.3|100.0|||||95% CI based on normal approximation to the binomial.|Candida krusei: Success||100.0|13.3|
72476245|NCT00548262|144478431|SUPERIORITY_OR_OTHER||percentage of participants with success|16.7|||||TWO_SIDED|95.0|0.0|46.5|||||95% CI based on normal approximation to the binomial.|Candida parapsilosis: Success||46.5|0.0|
72476246|NCT00548262|144478431|SUPERIORITY_OR_OTHER||percentage of participants with success|80.0|||||TWO_SIDED|95.0|55.2|100.0|||||95% CI based on normal approximation to the binomial.|Candida tropicalis: Success||100.0|55.2|
72476247|NCT00548262|144478431|SUPERIORITY_OR_OTHER||percentage of participants with success|57.1|||||TWO_SIDED|95.0|20.5|93.8|||||95% CI based on normal approximation to the binomial.|Unidentifiable: Success||93.8|20.5|
72476248|NCT00548262|144478432|SUPERIORITY_OR_OTHER||percentage of participants with success|52.4|||||TWO_SIDED|95.0|31.0|73.7|||||95% CI based on normal approximation to the binomial.|Candida albicans: Success||73.7|31.0|
72476249|NCT00548262|144478432|SUPERIORITY_OR_OTHER||percentage of participants with success|66.7|||||TWO_SIDED|95.0|13.3|100.0|||||95% CI based on normal approximation to the binomial.|Candida glabrata: Success||100.0|13.3|
72476250|NCT00548262|144478432|SUPERIORITY_OR_OTHER||percentage of participants with success|66.7|||||TWO_SIDED|95.0|13.3|100.0|||||95% CI based on normal approximation to the binomial.|Candida krusei: Success||100.0|13.3|
72476251|NCT00548262|144478432|SUPERIORITY_OR_OTHER||percentage of participants with success|16.7|||||TWO_SIDED|95.0|0.0|46.5|||||95% CI based on normal approximation to the binomial.|Candida parapsilosis: Success||46.5|0.0|
72508146|NCT00570739|144547562|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.0||||0.7051|TWO_SIDED|95.0|-18.64|12.64||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks||12.64|-18.64|0.7051
72508147|NCT00570739|144547562|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.8||||0.5267|TWO_SIDED|95.0|-19.72|10.13||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks LOCF||10.13|-19.72|0.5267
72410245|NCT03224468|144328800|SUPERIORITY|Power was determined to be 83.6% using a Monte Carlo simulation approach in which data were simulated from a multi-level linear regression model with a subject-varying random intercept, a shared baseline across WLC and MMC, and fixed effects for a change over each time point. Simulated data were fit with a linear model estimated via GEE - simulations were repeated 1000 times and power was estimated as the proportion where the contrast between WLC and MM had p\<0.05.|Mean Difference (Net)|-0.5|STANDARD_ERROR_OF_MEAN|0.45||0.5|TWO_SIDED|95.0|-1.4|0.4||The p-value is adjusted for multiple comparisons using per Benjamini \& Hochberg (1995) across the five primary outcome measures. Effects were deemed significant for p\<0.05.|Regression, Linear|Estimates were obtained using generalized estimating equations (GEE) with robust standard errors obtained by the sandwich estimator.|Estimate is the mean difference in scale score for MM above and beyond WLC (positive values denote higher score for MM).|The mean difference in scale scores between the MM and WLC groups was estimated via a linear model with a dummy-coded contrast (0 for WLC, 1 for MM). The model adjusted for change at weeks 4 and 12 of the study, and for a subject's scale scores at baseline.||0.4|-1.4|0.50
72476252|NCT00548262|144478432|SUPERIORITY_OR_OTHER||percentage of participants with success|80.0|||||TWO_SIDED|95.0|55.2|100.0|||||95% CI based on normal approximation to the binomial.|Candida tropicalis: Success||100.0|55.2|
72476253|NCT00548262|144478432|SUPERIORITY_OR_OTHER||percentage of participants with success|57.1|||||TWO_SIDED|95.0|20.5|93.8|||||95% CI based on normal approximation to the binomial.|Unidentifiable: Success||93.8|20.5|
72476254|NCT00548262|144478433|SUPERIORITY_OR_OTHER||percentage of participants with success|47.6|||||TWO_SIDED|95.0|26.3|69.0|||||95% CI based on normal approximation to the binomial.|Candida albicans: Success||69.0|26.3|
72476255|NCT00548262|144478433|SUPERIORITY_OR_OTHER||percentage of participants with success|66.7|||||TWO_SIDED|95.0|13.3|100.0|||||95% CI based on normal approximation to the binomial.|Candida krusei: Success||100.0|13.3|
72476256|NCT00548262|144478433|SUPERIORITY_OR_OTHER||percentage of participants with success|70.0|||||TWO_SIDED|95.0|41.6|98.4|||||95% CI based on normal approximation to the binomial.|Candida tropicalis: Success||98.4|41.6|
72508148|NCT00570739|144547563|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.85||||0.5882|TWO_SIDED|95.0|0.4|1.83||P-Value for comparing percentages was from the Cochran-Mantel-Haenszel test stratified by country.|Cochran-Mantel-Haenszel|||Baseline to 16 Weeks||1.83|0.40|0.5882
72508149|NCT00570739|144547563|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.93||||0.7098|TWO_SIDED|95.0|0.44|1.96||P-Value for comparing percentages was from the Cochran-Mantel-Haenszel test stratified by country.|Cochran-Mantel-Haenszel|||Baseline to 16 Weeks LOCF||1.96|0.44|0.7098
72508150|NCT00570739|144547563|SUPERIORITY_OR_OTHER|||||||0.6835||95.0|||||Regression, Logistic|Contained treatment and country as factors and baseline lab value as a covariate||Baseline to 16 Weeks||||0.6835
72508151|NCT00570739|144547563|SUPERIORITY_OR_OTHER|||||||0.8461||95.0|||||Regression, Logistic|Contained treatment and country as factors and baseline lab value as a covariate||Baseline to 16 Weeks LOCF||||0.8461
72508152|NCT00570739|144547564|SUPERIORITY_OR_OTHER|||||||0.2079||95.0||||P-Value for comparing percentages was from the Cochran-Mantel-Haenszel test stratified by country|Cochran-Mantel-Haenszel|||Baseline to 4 Weeks||||0.2079
72399307|NCT00202644|144305459|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Noninferiority of anagrelide could be concluded if lower limit of 95% Confidence Interval for the difference between treatment groups (Hydroxyurea - Anagrelide) was \> -100 x 10\^9/Liter.|Least Square Mean|-100.5|STANDARD_ERROR_OF_MEAN|39.93|||TWO_SIDED|95.0|-179.42|-21.49||||||||-21.49|-179.42|
72476257|NCT00548262|144478433|SUPERIORITY_OR_OTHER||percentage of participants with success|28.6|||||TWO_SIDED|95.0|0.0|62.0|||||95% CI based on normal approximation to the binomial.|Unidentifiable: Success||62.0|0.0|
72476258|NCT00548262|144478434|SUPERIORITY_OR_OTHER||percentage of participants with success|56.3|||||TWO_SIDED|95.0|39.1|73.4|||||95% CI based on normal approximation to the binomial.|ICU stay ≥ 4 days (Yes): Success||73.4|39.1|
72476259|NCT00548262|144478434|SUPERIORITY_OR_OTHER||percentage of participants with success|66.7|||||TWO_SIDED|95.0|40.0|93.3|||||95% CI based on normal approximation to the binomial.|ICU stay ≥ 4 days (No): Success||93.3|40.0|
72508153|NCT00570739|144547564|SUPERIORITY_OR_OTHER|||||||0.4053||95.0||||P-Value for comparing percentages was from the Cochran-Mantel-Haenszel test stratified by country|Cochran-Mantel-Haenszel|||Baseline to 8 Weeks||||0.4053
72476260|NCT00548262|144478434|SUPERIORITY_OR_OTHER||percentage of participants with success|54.5|||||TWO_SIDED|95.0|37.6|71.5|||||95% CI based on normal approximation to the binomial.|Mechanical ventilation (Yes): Success||71.5|37.6|
72476261|NCT00548262|144478434|SUPERIORITY_OR_OTHER||percentage of participants with success|72.7|||||TWO_SIDED|95.0|46.4|99.0|||||95% CI based on normal approximation to the binomial.|Mechanical ventilation (No): Success||99.0|46.4|
72476262|NCT00548262|144478434|SUPERIORITY_OR_OTHER||percentage of participants with success|56.4|||||TWO_SIDED|95.0|40.8|72.0|||||95% CI based on normal approximation to the binomial.|Antibiotics (Yes): Success||72.0|40.8|
72399308|NCT00202644|144305460|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Noninferiority of anagrelide could be concluded if lower limit of 95% Confidence Interval for the difference between treatment groups (Hydroxyurea - Anagrelide) was \> -100 x 10\^9/Liter.|Least Square Mean|-113.1|STANDARD_ERROR_OF_MEAN|37.56|||TWO_SIDED|95.0|-187.4|-38.83||||||Month 3||-38.83|-187.40|
72508154|NCT00570739|144547564|SUPERIORITY_OR_OTHER|||||||0.5752||95.0||||P-Value for comparing percentages was from the Cochran-Mantel-Haenszel test stratified by country|Cochran-Mantel-Haenszel|||Baseline to 12 Weeks||||0.5752
72476263|NCT00548262|144478434|SUPERIORITY_OR_OTHER||percentage of participants with success|80.0|||||TWO_SIDED|95.0|44.9|100.0|||||95% CI based on normal approximation to the binomial.|Antibiotics (No): Success||100.0|44.9|
72476264|NCT00548262|144478434|SUPERIORITY_OR_OTHER||percentage of participants with success|55.3|||||TWO_SIDED|95.0|39.5|71.1|||||95% CI based on normal approximation to the binomial.|CV Catheter (Yes): Success||71.1|39.5|
72476265|NCT00548262|144478434|SUPERIORITY_OR_OTHER||percentage of participants with success|83.3|||||TWO_SIDED|95.0|53.5|100.0|||||95% CI based on normal approximation to the binomial.|CV Catheter (No): Success||100.0|53.5|
72476266|NCT00548262|144478434|SUPERIORITY_OR_OTHER||percentage of participants with success|38.5|||||TWO_SIDED|95.0|12.0|64.9|||||95% CI based on normal approximation to the binomial.|TPN (Yes): Success||64.9|12.0|
72476267|NCT00548262|144478434|SUPERIORITY_OR_OTHER||percentage of participants with success|67.7|||||TWO_SIDED|95.0|51.3|84.2|||||95% CI based on normal approximation to the binomial.|TPN (No): Success||84.2|51.3|
72476268|NCT00548262|144478434|SUPERIORITY_OR_OTHER||percentage of participants with success|42.9|||||TWO_SIDED|95.0|6.2|79.5|||||95% CI based on normal approximation to the binomial.|Dialysis (Yes): Success||79.5|6.2|
72476269|NCT00548262|144478434|SUPERIORITY_OR_OTHER||percentage of participants with success|62.2|||||TWO_SIDED|95.0|46.5|77.8|||||95% CI based on normal approximation to the binomial.|Dialysis (No): Success||77.8|46.5|
72508155|NCT00570739|144547564|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.84||||0.7994|TWO_SIDED|95.0|0.25|2.29||P-Value for comparing percentages was from the Cochran-Mantel-Haenszel test stratified by country|Cochran-Mantel-Haenszel|||Baseline to 16 Weeks||2.29|0.25|0.7994
72508156|NCT00570739|144547564|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.98||||0.996|TWO_SIDED|95.0|0.32|3.03||P-Value for comparing percentages was from the Cochran-Mantel-Haenszel test stratified by country|Cochran-Mantel-Haenszel|||Baseline to 16 Weeks LOCF||3.03|0.32|0.9960
72476270|NCT00548262|144478434|SUPERIORITY_OR_OTHER||percentage of participants with success|57.9|||||TWO_SIDED|95.0|35.7|80.1|||||95% CI based on normal approximation to the binomial.|Abdominal surgery (Yes): Success||80.1|35.7|
72476271|NCT00548262|144478434|SUPERIORITY_OR_OTHER||percentage of participants with success|60.0|||||TWO_SIDED|95.0|40.8|79.2|||||95% CI based on normal approximation to the binomial.|Abdominal surgery (No): Success||79.2|40.8|
72476272|NCT00548262|144478434|SUPERIORITY_OR_OTHER||percentage of participants with success|59.1|||||TWO_SIDED|95.0|44.6|73.6|||||95% CI based on normal approximation to the binomial.|Solid organ transplant (No): Success||73.6|44.6|
72476273|NCT00548262|144478434|SUPERIORITY_OR_OTHER||percentage of participants with success|42.9|||||TWO_SIDED|95.0|6.2|79.5|||||95% CI based on normal approximation to the binomial.|Renal insufficiency (Yes): Success||79.5|6.2|
72476274|NCT00548262|144478434|SUPERIORITY_OR_OTHER||percentage of participants with success|62.2|||||TWO_SIDED|95.0|46.5|77.8|||||95% CI based on normal approximation to the binomial.|Renal insufficiency (No): Success||77.8|46.5|
72476275|NCT00548262|144478434|SUPERIORITY_OR_OTHER||percentage of participants with success|58.1|||||TWO_SIDED|95.0|43.4|72.9|||||95% CI based on normal approximation to the binomial.|Chemotherapy (No): Success||72.9|43.4|
72476276|NCT00548262|144478434|SUPERIORITY_OR_OTHER||percentage of participants with success|20.0|||||TWO_SIDED|95.0|0.0|55.1|||||95% CI based on normal approximation to the binomial.|Pancreatitis (Yes): Success||55.1|0.0|
72476277|NCT00548262|144478434|SUPERIORITY_OR_OTHER||percentage of participants with success|64.1|||||TWO_SIDED|95.0|49.0|79.2|||||95% CI based on normal approximation to the binomial.|Pancreatitis (No): Success||79.2|49.0|
72476278|NCT00548262|144478434|SUPERIORITY_OR_OTHER||percentage of participants with success|50.0|||||TWO_SIDED|95.0|21.7|78.3|||||95% CI based on normal approximation to the binomial.|Systemic steroids/immunos (Yes): Success||78.3|21.7|
72476279|NCT00548262|144478434|SUPERIORITY_OR_OTHER||percentage of participants with success|62.5|||||TWO_SIDED|95.0|45.7|79.3|||||95% CI based on normal approximation to the binomial.|Systemic steroids/immunos (No): Success||79.3|45.7|
72508157|NCT00570739|144547564|SUPERIORITY_OR_OTHER|||||||0.7783||95.0|||||Regression, Logistic|Contained treatment and country as factors and baseline lab value as a covariate||Baseline to 16 Weeks||||0.7783
72508158|NCT00570739|144547564|SUPERIORITY_OR_OTHER|||||||0.9774||95.0|||||Regression, Logistic|Contained treatment and country as factors and baseline lab value as a covariate||Baseline to 16 Weeks LOCF||||0.9774
72476280|NCT00548262|144478434|SUPERIORITY_OR_OTHER||percentage of participants with success|66.7|||||TWO_SIDED|95.0|13.3|100.0|||||95% CI based on normal approximation to the binomial.|Neutropenic: Success||100.0|13.3|
72476281|NCT00548262|144478434|SUPERIORITY_OR_OTHER||percentage of participants with success|62.1|||||TWO_SIDED|95.0|44.4|79.7|||||95% CI based on normal approximation to the binomial.|Non-neutropenic: Success||79.7|44.4|
72508159|NCT00570739|144547565|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||P-Value for comparing percentages was from the Cochran-Mantel-Haenszel test stratified by country.|Cochran-Mantel-Haenszel|||Baseline to 4 Weeks||||<0.0001
72508160|NCT00570739|144547565|SUPERIORITY_OR_OTHER|||||||0.4058||95.0||||P-Value for comparing percentages was from the Cochran-Mantel-Haenszel test stratified by country.|Cochran-Mantel-Haenszel|||Baseline to 8 Weeks||||0.4058
72508161|NCT00570739|144547565|SUPERIORITY_OR_OTHER|||||||0.0254||95.0||||P-Value for comparing percentages was from the Cochran-Mantel-Haenszel test stratified by country.|Cochran-Mantel-Haenszel|||Baseline to 12 Weeks||||0.0254
72476282|NCT00548262|144478435|SUPERIORITY_OR_OTHER||percentage of participants with success|56.3|||||TWO_SIDED|95.0|39.1|73.4|||||95% CI based on normal approximation to the binomial.|ICU stay ≥ 4 days (Yes): Success||73.4|39.1|
72476283|NCT00548262|144478435|SUPERIORITY_OR_OTHER||percentage of participants with success|66.7|||||TWO_SIDED|95.0|40.0|93.3|||||95% CI based on normal approximation to the binomial.|ICU stay ≥ 4 days (No): Success||93.3|40.0|
72476284|NCT00548262|144478435|SUPERIORITY_OR_OTHER||percentage of participants with success|54.5|||||TWO_SIDED|95.0|37.6|71.5|||||95% CI based on normal approximation to the binomial.|Mechanical ventilation (Yes): Success||71.5|37.6|
72566306|NCT02697773|144663260|SUPERIORITY||Least Square Mean Difference|-0.86|STANDARD_ERROR_OF_MEAN|0.24||0.0004|TWO_SIDED|95.0|-1.33|-0.38|||ANCOVA|||Week 12:Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariate, and study site as a random effect.||-0.38|-1.33|0.0004
72566307|NCT02697773|144663260|SUPERIORITY||Least Square Mean Difference|-1.05|STANDARD_ERROR_OF_MEAN|0.24|<|0.0001|TWO_SIDED|95.0|-1.52|-0.58|||ANCOVA|||Week 12: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariate, and study site as a random effect.||-0.58|-1.52|<.0001
72566308|NCT02697773|144663262|SUPERIORITY||Least Mean Square Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.07||0.0236|TWO_SIDED|95.0|-0.32|-0.02|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline PGA of osteoarthritis and baseline diary average pain as covariate, and study site as a random effect.||-0.02|-0.32|0.0236
72476285|NCT00548262|144478435|SUPERIORITY_OR_OTHER||percentage of participants with success|72.7|||||TWO_SIDED|95.0|46.4|99.0|||||95% CI based on normal approximation to the binomial.|Mechanical ventilation (No): Success||99.0|46.4|
72476286|NCT00548262|144478435|SUPERIORITY_OR_OTHER||percentage of participants with success|56.4|||||TWO_SIDED|95.0|40.8|72.0|||||95% CI based on normal approximation to the binomial.|Antibiotics (Yes): Success||72.0|40.8|
72476287|NCT00548262|144478435|SUPERIORITY_OR_OTHER||percentage of participants with success|80.0|||||TWO_SIDED|95.0|44.9|100.0|||||95% CI based on normal approximation to the binomial.|Antibiotics (No): Success||100.0|44.9|
72476288|NCT00548262|144478435|SUPERIORITY_OR_OTHER||percentage of participants with success|55.3|||||TWO_SIDED|95.0|39.5|71.1|||||95% CI based on normal approximation to the binomial.|CV Catheter (Yes): Success||71.1|39.5|
72476289|NCT00548262|144478435|SUPERIORITY_OR_OTHER||percentage of participants with success|83.3|||||TWO_SIDED|95.0|53.5|100.0|||||95% CI based on normal approximation to the binomial.|CV Catheter (No): Success||100.0|53.5|
72476290|NCT00548262|144478435|SUPERIORITY_OR_OTHER||percentage of participants with success|46.2|||||TWO_SIDED|95.0|19.1|73.3|||||95% CI based on normal approximation to the binomial.|TPN (Yes): Success||73.3|19.1|
72476291|NCT00548262|144478435|SUPERIORITY_OR_OTHER||percentage of participants with success|64.5|||||TWO_SIDED|95.0|47.7|81.4|||||95% CI based on normal approximation to the binomial.|TPN (No): Success||81.4|47.7|
72508162|NCT00570739|144547565|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.62||||0.1499|TWO_SIDED|95.0|0.74|3.55||P-Value for comparing percentages was from the Cochran-Mantel-Haenszel test stratified by country.|Cochran-Mantel-Haenszel|||Baseline to 16 Weeks||3.55|0.74|0.1499
72476292|NCT00548262|144478435|SUPERIORITY_OR_OTHER||percentage of participants with success|42.9|||||TWO_SIDED|95.0|6.2|79.5|||||95% CI based on normal approximation to the binomial.|Dialysis (Yes): Success||79.5|6.2|
72476293|NCT00548262|144478435|SUPERIORITY_OR_OTHER||percentage of participants with success|62.2|||||TWO_SIDED|95.0|46.5|77.8|||||95% CI based on normal approximation to the binomial.|Dialysis (No): Success||77.8|46.5|
72476294|NCT00548262|144478435|SUPERIORITY_OR_OTHER||percentage of participants with success|63.2|||||TWO_SIDED|95.0|41.5|84.8|||||95% CI based on normal approximation to the binomial.|Abdominal surgery (Yes): Success||84.8|41.5|
72476295|NCT00548262|144478435|SUPERIORITY_OR_OTHER||percentage of participants with success|56.0|||||TWO_SIDED|95.0|36.5|75.5|||||95% CI based on normal approximation to the binomial.|Abdominal surgery (No): Success||75.5|36.5|
72476296|NCT00548262|144478435|SUPERIORITY_OR_OTHER||percentage of participants with success|59.1|||||TWO_SIDED|95.0|44.6|73.6|||||95% CI based on normal approximation to the binomial.|Solid organ transplant (No): Success||73.6|44.6|
72476297|NCT00548262|144478435|SUPERIORITY_OR_OTHER||percentage of participants with success|42.9|||||TWO_SIDED|95.0|6.2|79.5|||||95% CI based on normal approximation to the binomial.|Renal insufficiency (Yes): Success||79.5|6.2|
72476298|NCT00548262|144478435|SUPERIORITY_OR_OTHER||percentage of participants with success|62.2|||||TWO_SIDED|95.0|46.5|77.8|||||95% CI based on normal approximation to the binomial.|Renal insufficiency (No): Success||77.8|46.5|
72508163|NCT00570739|144547565|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.08||||0.042|TWO_SIDED|95.0|0.97|4.45||P-Value for comparing percentages was from the Cochran-Mantel-Haenszel test stratified by country.|Cochran-Mantel-Haenszel|||Baseline to 16 Weeks LOCF||4.45|0.97|0.0420
72508164|NCT00570739|144547565|SUPERIORITY_OR_OTHER|||||||0.224||95.0|||||Regression, Logistic|Contained treatment and country as factors and baseline lab value as a covariate||Baseline to 16 Weeks||||0.2240
72399309|NCT00202644|144305460|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Noninferiority of anagrelide could be concluded if lower limit of 95% Confidence Interval for the difference between treatment groups (Hydroxyurea - Anagrelide) was \> -100 x 10\^9/Liter.|Least Square Mean|-68.3|STANDARD_ERROR_OF_MEAN|43.83|||TWO_SIDED|95.0|-154.95|18.43||||||Month 36||18.43|-154.95|
72399310|NCT00469092|144305481|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is shown if the upper limit of the 95% CI is less than 0.4%. Furthermore, superiority of BIAsp 30 OD over insulin glargine OD was shown if the upper limit of the 95% CI for the difference is lower than 0%. Equivalence is shown if the upper limit of the 95% CI for the difference is lower than 0.4% and the lower limit of the 95% CI is greater than -0.4%.|Mean Difference (Net)|-0.16||||0.029||95.0|-0.3|-0.02||P-value is for the test for difference in means equals 0 against the alternative that the difference is different from 0.|Regression, Linear|||HbA1c was compared between the treatment groups by fitting a linear regression model (ANCOVA) with treatment and country as factors and the baseline values as a continuous covariate. Mean and SE are estimated from the model.||-0.02|-0.30|0.029
72399311|NCT00469092|144305482|SUPERIORITY_OR_OTHER|||||||0.0059||95.0||||P-value for parallelism is overall test for parallel time profiles between treatment groups i.e. time by treatment group interaction effect.|Mixed Models Analysis|||The profiles were compared between the treatment groups by fitting a repeated measures mixed model including treatment, time, the treatment-by-time interaction and country as fixed effects, and subject as random effect.||||0.0059
72399312|NCT00469092|144305483|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.914||||||95.0|0.57|1.47|||||The OR and 95% CI is for the HbA1c \<= 6.5% treatment target.|||1.47|0.57|
72399313|NCT00469092|144305483|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.014||||||95.0|0.67|1.54|||||The OR and 95% CI is for the HbA1c \< 7.0% treatment target.|||1.54|0.67|
72399314|NCT00469092|144305483|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.131||||||95.0|0.72|1.77|||||The OR and 95% CI is for the reduction more than 1.0% from baseline treatment target.|||1.77|0.72|
72399315|NCT00469092|144305483|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.905||||||95.0|0.59|1.38|||||The OR and 95% CI is for the HbA1c \< 7% no nocturnal (00:00-06:00) hypoglycemia treatment target|||1.38|0.59|
72399316|NCT00469092|144305483|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.181||||||95.0|0.74|1.87|||||The OR and 95% CI is for the HbA1c \< 7%, no daytime (06:01-23:59) hypoglycemia treatment target|||1.87|0.74|
72566309|NCT02697773|144663262|SUPERIORITY||Least Square Mean Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.07||0.0958|TWO_SIDED|95.0|-0.27|0.02|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline PGA of osteoarthritis subscale and baseline diary average pain as covariate, and study site as a random effect.||0.02|-0.27|0.0958
72399317|NCT00469092|144305483|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.122||||||95.0|0.69|1.82|||||The OR and 95% CI is for the HbA1c \< 7%, no hypoglycemia treatment target.|||1.82|0.69|
72399318|NCT00469092|144305484|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.04||||||95.0|-2.4|2.48|||||The mean difference and 95% CI is for the burden score. The scores were compared between the treatment groups by fitting a linear regression model with treatment and country as factors and the baseline values as a continuous covariate.|The Diab MedSat measure was scored as an overall score as well as three subscale scores. The scores were transformed to a 0-100 scale with higher scores indicating greater satisfaction. The score of the subscales was computed as the mean of the items in each subscale. The overall score is the mean of all three subscales.||2.48|-2.40|
72399319|NCT00469092|144305484|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.22||||||95.0|-3.56|3.11|||||The mean difference and 95% CI is for the efficacy score. The scores were compared between the treatment groups by fitting a linear regression model with treatment and country as factors and the baseline values as a continuous covariate.|The Diab MedSat measure was scored as an overall score as well as three subscale scores. The scores were transformed to a 0-100 scale with higher scores indicating greater satisfaction. The score of the subscales was computed as the mean of the items in each subscale. The overall score is the mean of all three subscales.||3.11|-3.56|
72476299|NCT00548262|144478435|SUPERIORITY_OR_OTHER||percentage of participants with success|58.1|||||TWO_SIDED|95.0|43.4|72.9|||||95% CI based on normal approximation to the binomial.|Chemotherapy (No): Success||72.9|43.4|
72476300|NCT00548262|144478435|SUPERIORITY_OR_OTHER||percentage of participants with success|40.0|||||TWO_SIDED|95.0|0.0|82.9|||||95% CI based on normal approximation to the binomial.|Pancreatitis (Yes): Success||82.9|0.0|
72476301|NCT00548262|144478435|SUPERIORITY_OR_OTHER||percentage of participants with success|61.5|||||TWO_SIDED|95.0|46.3|76.8|||||95% CI based on normal approximation to the binomial.|Pancreatitis (No): Success||76.8|46.3|
72476302|NCT00548262|144478435|SUPERIORITY_OR_OTHER||percentage of participants with success|58.3|||||TWO_SIDED|95.0|30.4|86.2|||||95% CI based on normal approximation to the binomial.|Systemic steroids/immunos (Yes): Success||86.2|30.4|
72476303|NCT00548262|144478435|SUPERIORITY_OR_OTHER||percentage of participants with success|59.4|||||TWO_SIDED|95.0|42.4|76.4|||||95% CI based on normal approximation to the binomial.|Systemic steroids/immunos (No): Success||76.4|42.4|
72476304|NCT00548262|144478435|SUPERIORITY_OR_OTHER||percentage of participants with success|66.7|||||TWO_SIDED|95.0|13.3|100.0|||||95% CI based on normal approximation to the binomial.|Neutropenic: Success||100.0|13.3|
72476305|NCT00548262|144478435|SUPERIORITY_OR_OTHER||percentage of participants with success|62.1|||||TWO_SIDED|95.0|44.4|79.7|||||95% CI based on normal approximation to the binomial.|Non-neutropenic: Success||79.7|44.4|
72476306|NCT00548262|144478436|SUPERIORITY_OR_OTHER||percentage of participants with success|37.5|||||TWO_SIDED|95.0|20.7|54.3|||||95% CI based on normal approximation to the binomial.|ICU stay ≥ 4 days (Yes): Success||54.3|20.7|
72476307|NCT00548262|144478436|SUPERIORITY_OR_OTHER||percentage of participants with success|75.0|||||TWO_SIDED|95.0|50.5|99.5|||||95% CI based on normal approximation to the binomial.|ICU stay ≥ 4 days (No): Success||99.5|50.5|
72476308|NCT00548262|144478436|SUPERIORITY_OR_OTHER||percentage of participants with success|39.4|||||TWO_SIDED|95.0|22.7|56.1|||||95% CI based on normal approximation to the binomial.|Mechanical ventilation (Yes): Success||56.1|22.7|
72508165|NCT00570739|144547565|SUPERIORITY_OR_OTHER|||||||0.0593||95.0|||||Regression, Logistic|Contained treatment and country as factors and baseline lab value as a covariate||Baseline to 16 Weeks LOCF||||0.0593
72508166|NCT00570739|144547566|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.66||||0.4794|TWO_SIDED|95.0|0.31|1.4||P-Value for comparing percentages was from the Cochran-Mantel-Haenszel test stratified by country.|Cochran-Mantel-Haenszel|||Baseline to 16 Weeks||1.40|0.31|0.4794
72508167|NCT00570739|144547566|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.75||||0.6667|TWO_SIDED|95.0|0.37|1.55||P-Value for comparing percentages was from the Cochran-Mantel-Haenszel test stratified by country.|Cochran-Mantel-Haenszel|||Baseline to 16 Weeks LOCF||1.55|0.37|0.6667
72508168|NCT00570739|144547566|SUPERIORITY_OR_OTHER|||||||0.2768||95.0|||||Regression, Logistic|Contained treatment and country as factors and baseline lab value as a covariate||Baseline to 16 Weeks||||0.2768
72508169|NCT00570739|144547566|SUPERIORITY_OR_OTHER|||||||0.4395||95.0|||||Regression, Logistic|Contained treatment and country as factors and baseline lab value as a covariate||Baseline to 16 Weeks LOCF||||0.4395
72508170|NCT00570739|144547567|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.43||||0.1375|TWO_SIDED|95.0|0.89|6.64||P-Value for comparing percentages was from the Cochran-Mantel-Haenszel test stratified by country.|Cochran-Mantel-Haenszel|||Baseline to 16 Weeks||6.64|0.89|0.1375
72508171|NCT00570739|144547567|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.22||||0.1996|TWO_SIDED|95.0|0.85|5.82|||Cochran-Mantel-Haenszel|P-Value for comparing percentages was from the Cochran-Mantel-Haenszel test stratified by country.||Baseline to 16 Weeks LOCF||5.82|0.85|0.1996
72508172|NCT00570739|144547567|SUPERIORITY_OR_OTHER|||||||0.0829||95.0|||||Regression, Logistic|Contained treatment and country as factors and baseline lab value as a covariate||Baseline to 16 Weeks||||0.0829
72508173|NCT00570739|144547567|SUPERIORITY_OR_OTHER|||||||0.1037||95.0|||||Regression, Logistic|Contained treatment and country as factors and baseline lab value as a covariate||Baseline to 16 Weeks LOCF||||0.1037
72508174|NCT00325442|144547571|SUPERIORITY_OR_OTHER||Hodges-Lehmann|11.0||||0.072|TWO_SIDED|95.0|0.0|22.0|||ANCOVA|||Change in 6MWD from Baseline to Week 16||22|0|0.072
72508175|NCT00325442|144547572|SUPERIORITY_OR_OTHER||Hodges-Lehmann (H-L)|0.0||||0.062|TWO_SIDED|95.0|-1.0|0.0|||Wilcoxon rank-sum test|||Change in Borg dyspnea score from Baseline to Week 16||0.0|-1.0|0.062
72399320|NCT00469092|144305484|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.39||||||95.0|-3.14|2.35|||||The mean difference and 95% CI is for the symptoms score. The scores were compared between the treatment groups by fitting a linear regression model with treatment and country as factors and the baseline values as a continuous covariate.|The Diab MedSat measure was scored as an overall score as well as three subscale scores. The scores were transformed to a 0-100 scale with higher scores indicating greater satisfaction. The score of the subscales was computed as the mean of the items in each subscale. The overall score is the mean of all three subscales.||2.35|-3.14|
72508176|NCT00325442|144547573|SUPERIORITY_OR_OTHER|||||||0.491||95.0|||||Fisher Exact|||||||0.491
72508177|NCT00325442|144547574|SUPERIORITY_OR_OTHER||Hodges-Lehmann (H-L)|0.0||||0.011|TWO_SIDED|95.0|0.0|1.0|||Wilcoxon sum-rank test|||Change in dyspnea-fatigue index from Baseline to Week 16||1.0|0.0|0.011
72508178|NCT00325442|144547576|SUPERIORITY_OR_OTHER||Hodges-Lehmann (H-L)|13.0||||0.015|TWO_SIDED|95.0|3.0|23.0|||ANCOVA|||Change in 6MWD from Baseline to Week 12||23.0|3.0|0.015
72508179|NCT00325442|144547577|SUPERIORITY_OR_OTHER||Hodges-Lehmann|9.0||||0.051|TWO_SIDED|95.0|0.0|18.0|||ANCOVA|||Change in 6MWD from Baseline to Week 8||18.0|0.0|0.051
72508180|NCT00325442|144547578|SUPERIORITY_OR_OTHER||Hodges-Lehmann ( H-L)|4.0||||0.238|TWO_SIDED|95.0|-2.4|12.0|||ANCOVA|||Change in 6MWD from Baseline to Week 4||12.0|-2.4|0.238
72508181|NCT00325442|144547579|SUPERIORITY_OR_OTHER||Hodges-Lehmann (H-L)|24.0||||0.121|TWO_SIDED|95.0|0.0|45.0|||ANCOVA|||Change in 6MWD from Baseline to Week 16||45|0|0.121
72508182|NCT00325442|144547580|SUPERIORITY_OR_OTHER||Hodges-Lehmann (H-L)|15.0||||0.069|TWO_SIDED|95.0|-7.0|41.0|||ANCOVA|||Change in 6MWD from Baseline to Week 16||41|-7|0.069
72508183|NCT00325442|144547581|SUPERIORITY_OR_OTHER||Hodges-Lehmann (H-L)|4.0||||0.889|TWO_SIDED|95.0|-15.0|24.0|||ANCOVA|||Change in 6MWD from Baseline to Week 16||24|-15|0.889
72508184|NCT00325442|144547582|SUPERIORITY_OR_OTHER||Hodges-Lehmann (H-L)|0.0||||0.966|TWO_SIDED|95.0|-23.0|24.0|||ANCOVA|||Change in 6MWD from Baseline to Week 16||24|-23|0.966
72508185|NCT00325442|144547584|SUPERIORITY_OR_OTHER||Hodges-Lehmann (H-L)|5.0||||0.853|TWO_SIDED|95.0|-16.0|28.0|||ANCOVA|||Change in 6MWD from Baseline to Week 16||28|-16|0.853
72508186|NCT00325442|144547585|SUPERIORITY_OR_OTHER||Hodges-Lehmann (H-L)|7.0||||0.327|TWO_SIDED|95.0|-7.0|21.0|||ANCOVA|||Change in 6MWD from Baseline to Week 16||21|-7|0.327
72508187|NCT00325442|144547586|SUPERIORITY_OR_OTHER||Hodges-Lehmann (H-L)|29.5||||0.085|TWO_SIDED|95.0|1.0|73.0|||ANCOVA|||Change in 6MWD from Baseline to Week 16||73|1|0.085
72508188|NCT00325442|144547587|SUPERIORITY_OR_OTHER||Hodges-Lehmann (H-L)|5.0||||0.615|TWO_SIDED|95.0|-12.0|24.0|||ANCOVA|||Change in 6MWD from Baseline to Week 16||24|-12|0.615
72508189|NCT00325442|144547588|SUPERIORITY_OR_OTHER||Hodges-Lehmann (H-L)|17.0||||0.23|TWO_SIDED|95.0|-6.0|40.0|||ANCOVA|||Change in 6MWD from Baseline to Week 16||40|-6|0.230
72508190|NCT00325442|144547589|SUPERIORITY_OR_OTHER||Hodges-Lehmann (H-L)|10.0||||0.209|TWO_SIDED|95.0|-6.0|28.0|||ANCOVA|||Change in 6MWD from Baseline to Week 16||28|-6|0.209
72508191|NCT01729598|144547592|SUPERIORITY|||||||0.55|||||||t-test, 2 sided|||||||0.55
72508192|NCT01729598|144547593|SUPERIORITY|||||||0.19|||||||t-test, 2 sided|||||||0.19
72508193|NCT01729598|144547594|SUPERIORITY|||||||0.02|||||||t-test, 2 sided|||||||0.02
72508194|NCT01729598|144547595|SUPERIORITY|||||||0.31|||||||t-test, 2 sided|||||||0.31
72508195|NCT00803244|144547630|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.49||||0.2344||95.0|-1.3|0.32|||ANCOVA|||||0.32|-1.30|0.2344
72508196|NCT00803244|144547631|SUPERIORITY_OR_OTHER||LS Mean difference vs. Placebo|-0.09||||0.0401|TWO_SIDED|95.0|-0.18|0.0|||ANCOVA||Relative LS Means difference (%) = -19.7|||0.00|-0.18|0.0401
72508197|NCT00053846|144547682|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.483|STANDARD_ERROR_OF_MEAN|0.275||0.08|TWO_SIDED|95.0|-1.02|0.0576|||ANCOVA||Multiple Imputation (MI) used for estimates. MICE software in R was used to generate 100 imputed datasets. ANCOVA was run on each, and results were pooled.|H0: The true difference in means is equal to zero. Ha: The true difference in means is not equal to zero.||0.0576|-1.020|0.080
72508198|NCT00064662|144547683|SUPERIORITY_OR_OTHER||Other|0.0||||0.01||95.0|||||Log Rank|||Time to event analysis of 24 month success rates. Null hypothesis is that the distributions in the two groups are equal.||||0.01
72623244|NCT01905540|144777091|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The statistical comparison of log-transformed pharmacokinetic parameters between the single-dose treatment groups (Treatments AQ and SS) was based on the 90% CI for the ratio of the geometric means. If the 90% CI was entirely contained within the acceptance range of 0.8-1.25 then it was concluded that there was no statistically significant difference between treatments for the relevant parameter. Doses were normalized to the SSP-004184AQ (40mg/kg) dose prior to statistical analysis.|Ratio of geometric LS means|1.244|||||TWO_SIDED|90.0|1.081|1.43||||||||1.430|1.081|
72476309|NCT00548262|144478436|SUPERIORITY_OR_OTHER||percentage of participants with success|72.7|||||TWO_SIDED|95.0|46.4|99.0|||||95% CI based on normal approximation to the binomial.|Mechanical ventilation (No): Success||99.0|46.4|
72476310|NCT00548262|144478436|SUPERIORITY_OR_OTHER||percentage of participants with success|48.7|||||TWO_SIDED|95.0|33.0|64.4|||||95% CI based on normal approximation to the binomial.|Antibiotics (Yes): Success||64.4|33.0|
72476311|NCT00548262|144478436|SUPERIORITY_OR_OTHER||percentage of participants with success|40.0|||||TWO_SIDED|95.0|0.0|82.9|||||95% CI based on normal approximation to the binomial.|Antibiotics (No): Success||82.9|0.0|
72476312|NCT00548262|144478436|SUPERIORITY_OR_OTHER||percentage of participants with success|47.4|||||TWO_SIDED|95.0|31.5|63.2|||||95% CI based on normal approximation to the binomial.|CV Catheter (Yes): Success||63.2|31.5|
72476313|NCT00548262|144478436|SUPERIORITY_OR_OTHER||percentage of participants with success|50.0|||||TWO_SIDED|95.0|10.0|90.0|||||95% CI based on normal approximation to the binomial.|CV Catheter (No): Success||90.0|10.0|
72476314|NCT00548262|144478436|SUPERIORITY_OR_OTHER||percentage of participants with success|38.5|||||TWO_SIDED|95.0|12.0|64.9|||||95% CI based on normal approximation to the binomial.|TPN (Yes): Success||64.9|12.0|
72476315|NCT00548262|144478436|SUPERIORITY_OR_OTHER||percentage of participants with success|51.6|||||TWO_SIDED|95.0|34.0|69.2|||||95% CI based on normal approximation to the binomial.|TPN (No): Success||69.2|34.0|
72476316|NCT00548262|144478436|SUPERIORITY_OR_OTHER||percentage of participants with success|14.3|||||TWO_SIDED|95.0|0.0|40.2|||||95% CI based on normal approximation to the binomial.|Dialysis (Yes): Success||40.2|0.0|
72476317|NCT00548262|144478436|SUPERIORITY_OR_OTHER||percentage of participants with success|54.1|||||TWO_SIDED|95.0|38.0|70.1|||||95% CI based on normal approximation to the binomial.|Dialysis (No): Success||70.1|38.0|
72476318|NCT00548262|144478436|SUPERIORITY_OR_OTHER||percentage of participants with success|42.1|||||TWO_SIDED|95.0|19.9|64.3|||||95% CI based on normal approximation to the binomial.|Abdominal surgery (Yes): Success||64.3|19.9|
72476319|NCT00548262|144478436|SUPERIORITY_OR_OTHER||percentage of participants with success|52.0|||||TWO_SIDED|95.0|32.4|71.6|||||95% CI based on normal approximation to the binomial.|Abdominal surgery (No): Success||71.6|32.4|
72476320|NCT00548262|144478436|SUPERIORITY_OR_OTHER||percentage of participants with success|47.7|||||TWO_SIDED|95.0|33.0|62.5|||||95% CI based on normal approximation to the binomial.|Solid organ transplant (No): Success||62.5|33.0|
72476321|NCT00548262|144478436|SUPERIORITY_OR_OTHER||percentage of participants with success|14.3|||||TWO_SIDED|95.0|0.0|40.2|||||95% CI based on normal approximation to the binomial.|Renal insufficiency (Yes): Success||40.2|0.0|
72476322|NCT00548262|144478436|SUPERIORITY_OR_OTHER||percentage of participants with success|54.1|||||TWO_SIDED|95.0|38.0|70.1|||||95% CI based on normal approximation to the binomial.|Renal insufficiency (No): Success||70.1|38.0|
72476323|NCT00548262|144478436|SUPERIORITY_OR_OTHER||percentage of participants with success|46.5|||||TWO_SIDED|95.0|31.6|61.4|||||95% CI based on normal approximation to the binomial.|Chemotherapy (No): Success||61.4|31.6|
72476324|NCT00548262|144478436|SUPERIORITY_OR_OTHER||percentage of participants with success|40.0|||||TWO_SIDED|95.0|0.0|82.9|||||95% CI based on normal approximation to the binomial.|Pancreatitis (Yes): Success||82.9|0.0|
72476325|NCT00548262|144478436|SUPERIORITY_OR_OTHER||percentage of participants with success|48.7|||||TWO_SIDED|95.0|33.0|64.4|||||95% CI based on normal approximation to the binomial.|Pancreatitis (No): Success||64.4|33.0|
72476326|NCT00548262|144478436|SUPERIORITY_OR_OTHER||percentage of participants with success|41.7|||||TWO_SIDED|95.0|13.8|69.6|||||95% CI based on normal approximation to the binomial.|Systemic steroids/immunos (Yes): Success||69.6|13.8|
72476327|NCT00548262|144478436|SUPERIORITY_OR_OTHER||percentage of participants with success|50.0|||||TWO_SIDED|95.0|32.7|67.3|||||95% CI based on normal approximation to the binomial.|Systemic steroids/immunos (No): Success||67.3|32.7|
72476328|NCT00548262|144478436|SUPERIORITY_OR_OTHER||percentage of participants with success|66.7|||||TWO_SIDED|95.0|13.3|100.0|||||95% CI based on normal approximation to the binomial.|Neutropenic: Success||100.0|13.3|
72476329|NCT00548262|144478436|SUPERIORITY_OR_OTHER||percentage of participants with success|51.7|||||TWO_SIDED|95.0|33.5|69.9|||||95% CI based on normal approximation to the binomial.|Non-neutropenic: Success||69.9|33.5|
72476330|NCT00548262|144478437|SUPERIORITY_OR_OTHER||percentage of participants with success|68.6|||||TWO_SIDED|95.0|53.2|84.0|||||95% CI based on normal approximation to the binomial.|APACHE \<20 (EIVT): Success||84.0|53.2|
72476331|NCT00548262|144478437|SUPERIORITY_OR_OTHER||percentage of participants with success|22.2|||||TWO_SIDED|95.0|0.0|49.4|||||95% CI based on normal approximation to the binomial.|APACHE ≥20 (EIVT): Success||49.4|0.0|
72476332|NCT00548262|144478437|SUPERIORITY_OR_OTHER||percentage of participants with success|71.4|||||TWO_SIDED|95.0|56.5|86.4|||||95% CI based on normal approximation to the binomial.|APACHE \<20 (EOT): Success||86.4|56.5|
72476333|NCT00548262|144478437|SUPERIORITY_OR_OTHER||percentage of participants with success|11.1|||||TWO_SIDED|95.0|0.0|31.6|||||95% CI based on normal approximation to the binomial.|APACHE ≥20 (EOT): Success||31.6|0.0|
72476334|NCT00548262|144478437|SUPERIORITY_OR_OTHER||percentage of participants with success|57.1|||||TWO_SIDED|95.0|40.7|73.5|||||95% CI based on normal approximation to the binomial.|APACHE \<20 (Week 2 F/U): Success||73.5|40.7|
72476335|NCT00548262|144478437|SUPERIORITY_OR_OTHER||percentage of participants with success|11.1|||||TWO_SIDED|95.0|0.0|31.6|||||95% CI based on normal approximation to the binomial.|APACHE ≥20 (Week 2 F/U): Success||31.6|0.0|
72476336|NCT02729831|144478478|SUPERIORITY||Mean Difference (Net)|9.0|||<|0.001|TWO_SIDED|95.0|6.0|12.0|||Regression, Linear|||The comparison groups were: Interactive decision versus Video decision aid.||12|6|<0.001
72399321|NCT00469092|144305484|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.11||||||95.0|-2.36|2.14|||Regression, Linear||The mean difference and 95% CI is for the overall score. The scores were compared between the treatment groups by fitting a linear regression model with treatment and country as factors and the baseline values as a continuous covariate.|Diab MedSat measure was scored as an overall score as well as three subscale scores, and transformed to a 0-100 scale with higher scores indicating greater satisfaction. The score of the subscales was computed as the mean of the items in each subscale. The overall score is the mean of all three subscales.||2.14|-2.36|
72476337|NCT02729831|144478479|SUPERIORITY||Odds Ratio (OR)|1.03||||0.86|TWO_SIDED|95.0|0.74|1.44|||Regression, Logistic|General Estimating Equations accounted for clustering of patients within surgeons and controlling for baseline EQ-5D, BMI, joint and education.||We tested for interaction effects. Comparison groups were: MD Usual Care vs. MD Provider report.||1.44|0.74|0.86
72476338|NCT02729831|144478479|SUPERIORITY||Odds Ratio (OR)|1.06||||0.75|TWO_SIDED|95.0|0.76|1.47|||Regression, Logistic|General Estimating Equations accounted for clustering of patients within surgeons and controlling for baseline EQ-5D, BMI, joint and education.||We tested for interaction effects. Comparison groups are: Interactive decision versus Video decision aid||1.47|0.76|0.75
72476339|NCT02729831|144478480|SUPERIORITY||Risk Difference (RD)|18.5|||<|0.001|TWO_SIDED|95.0|12.8|24.5|||Chi-squared|Compared patients who reported using all of the DA compared to everyone else.||Comparison groups were: patients who reported using all of the DA versus everyone else.||24.5|12.8|<0.001
72476340|NCT02729831|144478481|SUPERIORITY||Mean Difference (Net)|0.04|||<|0.001|TWO_SIDED|95.0|0.016|0.065|||Regression, Linear|Generalized Estimating Equation accounting for clustering within surgeons. Model included treatment, sex, age, education, site and joint.||We included all 4 study groups, but the comparison group was: informed, patient centered decision yes vs. no.||0.065|0.016|<0.001
72476341|NCT02729831|144478482|SUPERIORITY||Odds Ratio (OR)|25.7|||<|0.001|TWO_SIDED|95.0|16.5|40.1|||Regression, Logistic|General estimating equations were used to account for clustering of patients within surgeons.||We included all 4 study groups, but the comparison group was: informed, patient centered (IPC) decision yes vs. no. We excluded those who did not provide information to calculate the IPC variable.||40.1|16.5|<0.001
72476342|NCT01747551|144478484|SUPERIORITY|||||||0.72|||||||Log Rank|||||||0.72
72476343|NCT01142115|144478488|NON_INFERIORITY_OR_EQUIVALENCE|The estimated difference VAS(Monza) minus VAS(SpeediCath)(i.e. the upper confidence limit) shall be less than 1cm to demonstrate non-inferiority.|Mean Difference (Final Values)|1.052||||0.0018|TWO_SIDED|95.0|0.412|1.692|||Mixed Models Analysis|||||1.692|0.412|0.0018
72476344|NCT01142115|144478489|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.805|||<|0.0001|TWO_SIDED|95.0|2.604|12.939|||Regression, Logistic|||||12.939|2.604|<0.0001
72476345|NCT01142115|144478490|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.822||||0.616|TWO_SIDED|95.0|0.382|1.767|||Proportional odds regression model|||||1.767|0.382|0.6160
72476346|NCT01142115|144478491|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.117||||0.8014|TWO_SIDED|95.0|0.472|2.646|||Proportional odds regression model|||||2.646|0.472|0.8014
72476347|NCT01142115|144478492|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.503||||0.3085|TWO_SIDED|95.0|0.314|39.106|||Regression, Logistic|||||39.106|0.314|0.3085
72476348|NCT01142115|144478493|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.398||||0.4324|TWO_SIDED|95.0|0.606|3.225|||Proportional odds regression model|||||3.225|0.606|0.4324
72476349|NCT03406078|144478494|SUPERIORITY||Cumulative Odds Ratio|1.28||||0.434|TWO_SIDED|95.0|0.69|2.35|||Proportional odds model|Response variable: categorised % reduction from baseline in final OCS dose. Covariates in the model: treatment, region and daily OCS dose at baseline.||||2.35|0.69|0.434
72476350|NCT00350103|144478518|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.45|||=|0.041|TWO_SIDED|95.0|-0.88|-0.02|||ANCOVA||Estimated value is the difference of Least Square Means.|Last Observation Carried Forward (LOCF) procedure was applied for missing daily diary entries between start of trial medication and Visit 8 or last intake of trial medication in the case of discontinuation during the Titration or Maintenance Phase.||-0.02|-0.88|=0.0410
72476351|NCT00350103|144478518|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.23|||=|0.2902|TWO_SIDED|95.0|-0.65|0.2|||ANCOVA||Estimated value is the difference of Least Square Means.|Last Observation Carried Forward (LOCF) procedure was applied for missing daily diary entries between start of trial medication and Visit 8 or last intake of trial medication in the case of discontinuation during the Titration or Maintenance Phase.||0.20|-0.65|=0.2902
72476352|NCT00760474|144478556|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.07|STANDARD_DEVIATION|0.157||0.083||||||Significance was set at p \<0.05.|t-test, 2 sided||Mean difference between the pre-dose (baseline) and post-dose values calculated as post-dose minus pre-dose (post minus pre).|Glu/Cr posterior insula||||0.083
72476353|NCT00760474|144478556|SUPERIORITY_OR_OTHER_LEGACY|||||||0.436||95.0||||Significance was set at p \<0.05.|t-test, 2 sided|||Glu/Cr posterior insula||||0.436
72476354|NCT00760474|144478556|SUPERIORITY_OR_OTHER_LEGACY|||||||0.306||95.0|||||t-test, 2 sided|Significance was set at p \<0.05.||Gln/Cr posterior insula||||0.306
72476355|NCT00760474|144478556|SUPERIORITY_OR_OTHER_LEGACY|||||||0.809||95.0|||||t-test, 2 sided|Significance was set at p \<0.05.||Gln/Cr posterior insula||||0.809
72476356|NCT00760474|144478556|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.116|STANDARD_DEVIATION|0.177||0.016|||||||t-test, 2 sided|Significance was set at p \<0.05.|Mean difference between the pre-dose (baseline) and post-dose values calculated as post-dose minus pre-dose (post minus pre).|Glx/Cr posterior insula||||0.016
72476357|NCT00760474|144478556|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.029|STANDARD_DEVIATION|0.308||0.708||||||Significance was set at p \<0.05.|t-test, 2 sided||Mean difference between the pre-dose (baseline) and post-dose values calculated as post-dose minus pre-dose (post minus pre).|Glx/Cr posterior insula||||0.708
72476358|NCT00760474|144478556|SUPERIORITY_OR_OTHER_LEGACY|||||||0.809||95.0||||Significance was set at p \<0.050.|t-test, 2 sided|||Glu/Cr anterior insula||||0.809
72476359|NCT00760474|144478556|SUPERIORITY_OR_OTHER_LEGACY|||||||0.154||95.0||||Significance was set at p \<0.05.|t-test, 2 sided|||Glu/Cr anterior insula||||0.154
72476360|NCT00760474|144478556|SUPERIORITY_OR_OTHER_LEGACY|||||||0.96||95.0|||||t-test, 2 sided|Significance was set at p \<0.05.||Gln/Cr anterior insula||||0.960
72476361|NCT00760474|144478556|SUPERIORITY_OR_OTHER_LEGACY|||||||0.937||95.0|||||t-test, 2 sided|Significance was set at p \<0.05.||Gln/Cr anterior insula||||0.937
72508199|NCT00064662|144547684|SUPERIORITY_OR_OTHER||Chi-square|16.2|||<|0.001||95.0|||||Log Rank|||Time to event analysis of cumulative success rates in the two groups. Null hypothesis is that the distributions are equal in the two groups.||||<0.001
72508200|NCT00064662|144547684|SUPERIORITY_OR_OTHER||Other|0.0|||<|0.0001||95.0|||||Kalpan Meier (Wald statistic)|||Kaplan Meier time-to-event analysis of cumulative success rates. Used Wald test of equality of survival distributions.||||<0.0001
72508201|NCT03008590|144547685|SUPERIORITY|||||||0.9||||||Significance pre-specified at P\<0.05|Mixed Models Analysis|||Data from the primary or secondary outcome measures were the dependent variables. The patient was the random effect. Dependent fixed effects variables included treatment at the time of data collection (naltrexone or placebo), group (naltrexone first or placebo first), and week (4, 8, 12, and 16).||||0.90
72508202|NCT03008590|144547686|SUPERIORITY|||||||0.22||||||Significance pre-specified at P\<0.05|Mixed Models Analysis|||Data from the primary or secondary outcome measures were the dependent variables. The patient was the random effect. Dependent fixed effects variables included treatment at the time of data collection (naltrexone or placebo), group (naltrexone first or placebo first), and week (4, 8, 12, and 16).||||0.22
72508203|NCT03008590|144547687|SUPERIORITY|||||||0.02||||||Although significance was pre-specified at P\<0.05, it is suspected that this result is spurious due to multiple comparisons|Mixed Models Analysis|||Data from the primary or secondary outcome measures were the dependent variables. The patient was the random effect. Dependent fixed effects variables included treatment at the time of data collection (naltrexone or placebo), group (naltrexone first or placebo first), and week (4, 8, 12, and 16).||||0.02
72508204|NCT03008590|144547688|SUPERIORITY|||||||0.3||||||Significance pre-specified at P\<0.05|Mixed Models Analysis|||Data from the primary or secondary outcome measures were the dependent variables. The patient was the random effect. Dependent fixed effects variables included treatment at the time of data collection (naltrexone or placebo), group (naltrexone first or placebo first), and week (4, 8, 12, and 16).||||0.3
72508205|NCT03008590|144547689|SUPERIORITY|||||||0.04||||||Although significance was pre-specified at P\<0.05, it is suspected that this result is spurious due to multiple comparisons|Mixed Models Analysis|||Data from the primary or secondary outcome measures were the dependent variables. The patient was the random effect. Dependent fixed effects variables included treatment at the time of data collection (naltrexone or placebo), group (naltrexone first or placebo first), and week (4, 8, 12, and 16).||||0.04
72508206|NCT03008590|144547690|SUPERIORITY|||||||0.78||||||Significance pre-specified at P\<0.05|Mixed Models Analysis|||Data from the primary or secondary outcome measures were the dependent variables. The patient was the random effect. Dependent fixed effects variables included treatment at the time of data collection (naltrexone or placebo), group (naltrexone first or placebo first), and week (4, 8, 12, and 16).||||0.78
72508207|NCT03008590|144547691|SUPERIORITY|||||||0.92||||||Significance pre-specified at P\<0.05|Mixed Models Analysis|||Data from the primary or secondary outcome measures were the dependent variables. The patient was the random effect. Dependent fixed effects variables included treatment at the time of data collection (naltrexone or placebo), group (naltrexone first or placebo first), and week (4, 8, 12, and 16).||||0.92
72399322|NCT02024867|144305487|NON_INFERIORITY_OR_EQUIVALENCE|The sample size of 120 per group was calculated according to an assumed treatment cure rate of 95% with 10 days of antibiotics, and a non-inferiority margin of 7% (allowing up to 88% cure rate with 3 days of antibiotics), to achieve a power of 0.80 (alpha=0.05). An additional 25 patients were recruited to account for an estimated 10% lost to follow-up.|Rate Difference|4.0||||0.25|TWO_SIDED|95.0|-1.5|9.5|||Chi-squared|||||9.5|-1.5|0.25
72508208|NCT00872833|144547698|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Chi-squared|||||||<.001
72508209|NCT00872833|144547699|SUPERIORITY_OR_OTHER|||||||0.028|||||||Chi-squared|||||||0.028
72508210|NCT01417780|144547725|OTHER|||||||0.016|||||||ANOVA|||||||0.016
72508211|NCT01417780|144547726|OTHER|||||||0.019|||||||Chi-squared|||The null hypothesis was that the frequency of Day 14 SOFA score less than or equal to 1 was not different among treatment groups.||||0.019
72508212|NCT01417780|144547727|OTHER|||||||0.11||||||Wilcoxon p value represents comparison of active dose groups versus placebo group.|Wilcoxon (Mann-Whitney)|||||||0.11
72508213|NCT01417780|144547728|OTHER|||||||0.18||||||Wilcoxon p value represents comparison of active dose groups versus placebo group.|Wilcoxon (Mann-Whitney)|||||||0.18
72508214|NCT01417780|144547729|OTHER|||||||0.19||||||Wilcoxon p value represents comparison of active dose groups versus placebo group.|Wilcoxon (Mann-Whitney)|||||||0.19
72566310|NCT02697773|144663262|SUPERIORITY||Least Square Mean Difference|-0.26|STANDARD_ERROR_OF_MEAN|0.07||0.0007|TWO_SIDED|95.0|-0.4|-0.11|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline PGA of osteoarthritis and baseline diary average pain as covariate, and study site as a random effect.||-0.11|-0.40|0.0007
72399323|NCT02024867|144305488|NON_INFERIORITY_OR_EQUIVALENCE|described previously|Rate Difference|10.7||||0.02|TWO_SIDED|95.0|2.1|19.2|||Chi-squared|||||19.2|2.1|0.02
72508215|NCT01345786|144547730|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Acceptance criteria of 80 - 125% were used for bioequivalence evaluations (bioequivalence concluded when 90% confidence interval fully contained within acceptance criteria).|Ratio (Test/Ref %)|137.5||||||90.0|131.0|144.4|||||Commercial Batch Test / Phase 3 Batch Reference.|||144.4|131|
72508216|NCT01345786|144547730|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Acceptance criteria of 80 - 125% were used for bioequivalence evaluations (bioequivalence concluded when 90% confidence interval fully contained within acceptance criteria).|Ratio (Test/Ref %)|111.8||||||90.0|107.5|116.4|||||Commercial Batch Test / Phase 3 Batch Reference.|||116.4|107.5|
72508217|NCT01345786|144547731|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Acceptance criteria of 80 - 125% were used for bioequivalence evaluations (bioequivalence concluded when 90% confidence interval fully contained within acceptance criteria).|Ratio (Test/Ref %)|107.3||||||90.0|99.0|116.4|||||Commercial Batch Test / Phase 3 Batch Reference.|||116.4|99|
72508218|NCT01345786|144547731|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Acceptance criteria of 80 - 125% were used for bioequivalence evaluations (bioequivalence concluded when 90% confidence interval fully contained within acceptance criteria).|Ratio (Test/Ref %)|103.6||||||90.0|99.2|108.2|||||"Commercial Batch Test / Phase 3 Batch Reference.~In addition to the participants/profiles excluded, 1 participant from the Phase 3 Batch Reference group did not contribute to this comparison."|||108.2|99.2|
72399324|NCT02024867|144305489|NON_INFERIORITY_OR_EQUIVALENCE|described previously|Rate Difference|10.1||||0.03|TWO_SIDED|95.0|2.1|18.2|||Chi-squared|||||18.2|2.1|0.03
72399325|NCT02024867|144305490|NON_INFERIORITY_OR_EQUIVALENCE|described previously|Rate Difference|0.1|||>|0.05|TWO_SIDED|95.0|-6.9|7.0|||Chi-squared|||||7.0|-6.9|>0.05
72399326|NCT02024867|144305491|NON_INFERIORITY_OR_EQUIVALENCE|described previously|Rate Difference|10.3||||0.046|TWO_SIDED|95.0|0.8|19.9|||Chi-squared|||||19.9|0.8|0.046
72399327|NCT02024867|144305492|NON_INFERIORITY_OR_EQUIVALENCE|described previously|rate difference|0.0|||>|0.05|TWO_SIDED|95.0|||||Chi-squared|||||||>0.05
72399328|NCT03992781|144305522|SUPERIORITY||Relative change|-53.1|||<|0.001|||||||t-test|||Relative change in CUDOS score between Visit 3 and Visit 1 was tested by ratio t-test (paired t-test of logarithm) at 0.05 alpha level. This was expressed in percentage.||||<0.001
72399329|NCT03992781|144305523|SUPERIORITY||Relative change|-35.4|||<|0.001|||||||t-test|||Relative change in CUDOS score between Visit 2 and Visit 1 was tested by ratio t-test (paired t-test of logarithm) at 0.05 alpha level. This was expressed in percentage.||||<0.001
72399330|NCT03992781|144305524|SUPERIORITY||Relative change|-33.2|||<|0.001|||||||t-test|||Relative change in CUXOS score between Visit 2 and Visit 1 was tested by ratio t-test (paired t-test of logarithm) at 0.05 alpha level. This was expressed in percentage.||||<0.001
72399331|NCT03992781|144305524|SUPERIORITY||Relative change|-47.1|||<|0.001|||||||t-test|||Relative change in CUXOS score between Visit 3 and Visit 1 was tested by ratio t-test (paired t-test of logarithm) at 0.05 alpha level. This was expressed in percentage.||||<0.001
72476362|NCT00760474|144478556|SUPERIORITY_OR_OTHER_LEGACY|||||||0.897||95.0||||Significance was set at p \<0.05.|t-test, 2 sided|||Glx/Cr anterior insula||||0.897
72476363|NCT00760474|144478556|SUPERIORITY_OR_OTHER_LEGACY|||||||0.309||95.0||||Significance was set at p \<0.05.|t-test, 2 sided|||Glx/Cr anterior insula||||0.309
72476364|NCT00760474|144478557|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) Mean difference|0.032||||0.6347|TWO_SIDED|95.0|-0.1081|0.1714||Significance was set at p \<0.05.|Mixed Models Analysis|Mixed-effect repeated measure model included participant as a random effect; treatment, visit as fixed effects.||Anterior Cingulate||0.1714|-0.1081|0.6347
72476365|NCT00760474|144478557|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) Mean difference|-0.079||||0.5181|TWO_SIDED|95.0|-0.3356|0.1771||Significance was set at p \<0.05.|Mixed Models Analysis|Mixed-effect repeated measure model included participant as a random effect; treatment, visit as fixed effects.||BA22||0.1771|-0.3356|0.5181
72476366|NCT00760474|144478557|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) Mean difference|-0.072||||0.2987|TWO_SIDED|95.0|-0.2161|0.0714||Significance was set at p \<0.05.|Mixed Models Analysis|Mixed-effect repeated measure model included participant as a random effect; treatment, visit as fixed effects.||BA40||0.0714|-0.2161|0.2987
72476367|NCT00760474|144478557|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) Mean difference|0.029||||0.5151|TWO_SIDED|95.0|-0.064|0.1219||Significance was set at p \<0.05.|Mixed Models Analysis|Mixed-effect repeated measure model included participant as a random effect; treatment, visit as fixed effects.||L\_anIns||0.1219|-0.0640|0.5151
72476368|NCT00760474|144478557|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) Mean difference|-0.081||||0.2369|TWO_SIDED|95.0|-0.2228|0.0599||Significance was set at p \<0.05.|Mixed Models Analysis|Mixed-effect repeated measure model included participant as a random effect; treatment, visit as fixed effects.||L\_Amygdala||0.0599|-0.2228|0.2369
72476369|NCT00760474|144478557|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) Mean difference|-0.077||||0.0758|TWO_SIDED|95.0|-0.1642|0.0092||Significance was set at p \<0.05.|Mixed Models Analysis|Mixed-effect repeated measure model included participant as a random effect; treatment, visit as fixed effects.||L\_Cerebellum||0.0092|-0.1642|0.0758
72476370|NCT00760474|144478557|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) Mean difference|-0.025||||0.4609|TWO_SIDED|95.0|-0.0947|0.0452||Significance was set at p \<0.05.|Mixed Models Analysis|Mixed-effect repeated measure model included participant as a random effect; treatment, visit as fixed effects.||L\_DLPFC||0.0452|-0.0947|0.4609
72476371|NCT00760474|144478557|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) Mean difference|-0.111||||0.3813|TWO_SIDED|95.0|-0.3745|0.1524||Significance was set at p \<0.05.|Mixed Models Analysis|Mixed-effect repeated measure model included participant as a random effect; treatment, visit as fixed effects.||L\_Mid Insula||0.1524|-0.3745|0.3813
72476372|NCT00760474|144478557|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) Mean difference|0.02||||0.72|TWO_SIDED|95.0|-0.0964|0.1361||Significance was set at p \<0.05.|Mixed Models Analysis|Mixed-effect repeated measure model included participant as a random effect; treatment, visit as fixed effects.||L\_Mid Temporal Pole||0.1361|-0.0964|0.7200
72476373|NCT00760474|144478557|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) Mean difference|0.168||||0.2099|TWO_SIDED|95.0|-0.1065|0.4434||Significance was set at p \<0.05.|Mixed Models Analysis|Mixed-effect repeated measure model included participant as a random effect; treatment, visit as fixed effects.||L\_Orbito Front||0.4434|-0.1065|0.2099
72476374|NCT00760474|144478557|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) Mean difference|-0.003||||0.9551|TWO_SIDED|95.0|-0.1047|0.0992||Significance was set at p \<0.05.|Mixed Models Analysis|Mixed-effect repeated measure model included participant as a random effect; treatment, visit as fixed effects.||PAG||0.0992|-0.1047|0.9551
72476375|NCT00760474|144478557|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) Mean difference|0.0||||0.994|TWO_SIDED|95.0|-0.0855|0.0848||Significance was set at p \<0.05.|Mixed Models Analysis|Mixed-effect repeated measure model included participant as a random effect; treatment, visit as fixed effects.||Posterior Insula||0.0848|-0.0855|0.9940
72476376|NCT00760474|144478557|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) Mean difference|-0.049||||0.4291|TWO_SIDED|95.0|-0.1792|0.0806||Significance was set at p \<0.05.|Mixed Models Analysis|Mixed-effect repeated measure model included participant as a random effect; treatment, visit as fixed effects.||L\_Posterior Cingulate||0.0806|-0.1792|0.4291
72476377|NCT00760474|144478557|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) Mean difference|0.027||||0.467|TWO_SIDED|95.0|-0.0496|0.1028||Significance was set at p \<0.05.|Mixed Models Analysis|Mixed-effect repeated measure model included participant as a random effect; treatment, visit as fixed effects.||L\_Precuneus||0.1028|-0.0496|0.4670
72476378|NCT00760474|144478557|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) Mean difference|0.044||||0.4443|TWO_SIDED|95.0|-0.0752|0.1624||Significance was set at p \<0.05.|Mixed Models Analysis|Mixed-effect repeated measure model included participant as a random effect; treatment, visit as fixed effects.||L\_Putamen||0.1624|-0.0752|0.4443
72399332|NCT03992781|144305525|SUPERIORITY||Relative change|-27.6|||<|0.001|||||||t-test|||Relative change in JSEQ score between Visit 2 and Visit 1 was tested by ratio t-test (paired t-test of logarithm) at 0.05 alpha level. This was expressed in percentage.||||<0.001
72399333|NCT03992781|144305525|SUPERIORITY||Relative change|-34.5|||<|0.001|||||||t-test|||Relative change in JSEQ score between Visit 3 and Visit 1 was tested by ratio t-test (paired t-test of logarithm) at 0.05 alpha level. This was expressed in percentage.||||<0.001
72399334|NCT03992781|144305526|SUPERIORITY||Relative change|-43.4|||<|0.001|||||||t-test|||Relative change in VAS score between Visit 2 and Visit 1 was tested by ratio t-test (paired t-test of logarithm) at 0.05 alpha level. This was expressed in percentage.||||<0.001
72399335|NCT03992781|144305526|SUPERIORITY||Relative change|-35.4|||<|0.001|||||||t-test|||Relative change in VAS score between Visit 3 and Visit 1 was tested by ratio t-test (paired t-test of logarithm) at 0.05 alpha level. This was expressed in percentage.||||<0.001
72399336|NCT01086540|144305534|SUPERIORITY||Median Difference (Final Values)|23.1|STANDARD_ERROR_OF_MEAN|14.71||0.12|TWO_SIDED||||||Mixed Models Analysis||Estimate is for the difference (Rituximab - Placebo) at Week 24.|The null hypothesis was that the mean change in 6MWD between baseline and Week 24 does not differ between rituximab and placebo. A repeated measures random effect model was fit to model the distance walked as a function of treatment, visit week, a treatment by visit week interaction, and a quadratic visit term. A random slope and intercept were fit for each participant using a separate unstructured covariance matrix for each treatment group. The model included all available data up to Week 24.||||0.12
72399337|NCT01086540|144305535|SUPERIORITY||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.71||0.42|TWO_SIDED|||||P-values not adjusted for multiple comparisons.|Mixed Models Analysis|||A repeated measures mixed model was fit with PVR as the outcome and treatment, visit week (actual observed week), and their interaction as predictors. Random intercepts and slopes were fit for each participant using an unstructured covariance structure for each treatment group.||||0.42
72399338|NCT01086540|144305536|SUPERIORITY||Mean Difference (Final Values)|16.4|STANDARD_ERROR_OF_MEAN|15.1||0.28|TWO_SIDED|||||Week 48 value. P-values not adjusted for multiple comparisons.|Mixed Models Analysis||Estimate is for the difference (Rituximab - Placebo) at Week 48.|A repeated measures random effect model was fit to model the distance walked as a function of treatment, visit week, a treatment by visit week interaction, and a quadratic visit term. A random slope and intercept were fit for each participant using a separate unstructured covariance matrix for each treatment group. The model included all available data up to Week 48.||||0.28
72399339|NCT01086540|144305536|SUPERIORITY||Mean Difference (Final Values)|25.1|STANDARD_ERROR_OF_MEAN|11.5||0.031|TWO_SIDED|||||Week 24 value. P-values not adjusted for multiple comparisons.|Mixed Models Analysis||Estimate is for the difference (Rituximab - Placebo) at Week 24.|A repeated measures random effect model was fit to model the distance walked as a function of treatment, visit week, a treatment by visit week interaction, and a quadratic visit term. A random slope and intercept were fit for each participant using a separate unstructured covariance matrix for each treatment group. The model included all available data up to Week 48.||||0.031
72399340|NCT01086540|144305537|SUPERIORITY|||||||0.92||||||P-values not adjusted for multiple comparisons.|Log Rank|||Kaplan-Meier curves for time to clinical worsening were compared using a log-rank test.||||0.92
72399341|NCT01086540|144305538|SUPERIORITY|||||||0.36||||||P-values not adjusted for multiple comparisons.|Log Rank|||Kaplan-Meier curves for time to change or addition of PAH medications were compared using a log-rank test.||||0.36
72399342|NCT01086540|144305539|SUPERIORITY||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|2.7||0.81|TWO_SIDED|||||P-values not adjusted for multiple comparisons.|Mixed Models Analysis||Estimate is for the difference (Rituximab - Placebo) at Week 48.|A repeated measures random effect model was fit with the mental component score as the outcome, and treatment, visit week (actual observed week), and their interaction as predictors. Random intercepts and slopes were fit for each participant using an unstructured covariance structure for each treatment group.||||0.81
72399343|NCT01086540|144305540|SUPERIORITY||Mean Difference (Final Values)|-2.2|STANDARD_ERROR_OF_MEAN|2.1||0.3|TWO_SIDED|||||P-values not adjusted for multiple comparisons.|Mixed Models Analysis||Estimate is for the difference (Rituximab - Placebo) at Week 48.|A repeated measures random effect model was fit with the physical component score as the outcome, and treatment, visit week (actual observed week), and their interaction as predictors. Random intercepts and slopes were fit for each participant using an unstructured covariance structure for each treatment group.||||0.30
72399344|NCT01086540|144305541|SUPERIORITY||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.11||0.58|TWO_SIDED|||||P-values not adjusted for multiple comparisons.|Mixed Models Analysis||Estimate is for the difference (Rituximab - Placebo) at Week 48.|A repeated measures random effect model was fit with HAQ-DI as the outcome, and treatment, visit week (actual observed week), and their interaction as predictors. Random intercepts and slopes were fit for each participant using an unstructured covariance structure for each treatment group.||||0.58
72399345|NCT01086540|144305542|SUPERIORITY|||||||0.47||||||P-values not adjusted for multiple comparisons.|Regression, Linear|||A Poisson model was used to describe the rate of new digital ulcers (per week) as the outcome with treatment, number of digital ulcers at Baseline, and if the measurement was affected by changed or new PAH therapeutic agents as covariates.||||0.47
72399346|NCT01086540|144305543|SUPERIORITY||Mean Difference (Final Values)|-4.6|STANDARD_ERROR_OF_MEAN|5.7||0.43|TWO_SIDED|||||P-values not adjusted for multiple comparisons.|Mixed Models Analysis||Estimate is for the difference (Rituximab - Placebo) at Week 48.|A repeated measures random effect model was fit with severity of Raynaud's (0 to 100) as the outcome, and treatment, visit week (actual observed week), and their interaction as predictors. Random intercepts and slopes were fit for each participant using an unstructured covariance structure for each treatment group.||||0.43
72399347|NCT01086540|144305544|SUPERIORITY||Mean Difference (Final Values)|-1.3|STANDARD_ERROR_OF_MEAN|2.8||0.65|TWO_SIDED|||||P-values not adjusted for multiple comparisons.|Mixed Models Analysis||Estimate is for the difference (Rituximab - Placebo) at Week 48.|A repeated measures random effect model was fit with DLCO as the outcome, and treatment, visit week (actual observed week), and their interaction as predictors. Random intercepts and slopes were fit for each participant using an unstructured covariance structure for each treatment group.||||0.65
72566311|NCT02697773|144663262|SUPERIORITY||Least Mean Square Difference|-0.21|STANDARD_ERROR_OF_MEAN|0.07||0.004|TWO_SIDED|95.0|-0.36|-0.07|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline PGA of osteoarthritis and baseline diary average pain as covariate, and study site as a random effect.||-0.07|-0.36|0.0040
72566312|NCT02697773|144663262|SUPERIORITY||Least Square Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.08||0.0498|TWO_SIDED|95.0|-0.31|0.0|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline PGA of osteoarthritis and baseline diary average pain as covariate, and study site as a random effect.||-0.00|-0.31|0.0498
72566313|NCT02697773|144663262|SUPERIORITY||Least Square Mean Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.08||0.238|TWO_SIDED|95.0|-0.24|0.06|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline PGA of osteoarthritis and baseline diary average pain as covariate, and study site as a random effect.||0.06|-0.24|0.2380
72623245|NCT01905540|144777092|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The statistical comparison of log-transformed pharmacokinetic parameters between the single-dose treatment groups (Treatments AQ and SS) was based on the 90% CI for the ratio of the geometric means. If the 90% CI was entirely contained within the acceptance range of 0.8-1.25 then it was concluded that there was no statistically significant difference between treatments for the relevant parameter. Doses were normalized to the SSP-004184AQ (40mg/kg) dose prior to statistical analysis.|Geometric LS Means|1.233|||||TWO_SIDED|90.0|1.07|1.422||||||||1.422|1.070|
72623246|NCT01905540|144777093|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The statistical comparison of log-transformed pharmacokinetic parameters between the single-dose treatment groups (Treatments AQ and SS) was based on the 90% CI for the ratio of the geometric means. If the 90% CI was entirely contained within the acceptance range of 0.8-1.25 then it was concluded that there was no statistically significant difference between treatments for the relevant parameter. Doses were normalized to the SSP-004184AQ (40mg/kg) dose prior to statistical analysis.|Ratio of geometric LS means|1.344|||||TWO_SIDED|90.0|1.135|1.592||||||||1.592|1.135|
72508219|NCT01345786|144547732|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Acceptance criteria of 80 - 125% were used for bioequivalence evaluations (bioequivalence concluded when 90% confidence interval fully contained within acceptance criteria).|Ratio (Test/Ref %)|110.0||||||90.0|106.4|113.7|||||Commercial Batch Test / Phase 3 Batch Reference.|Analysis for AUClast||113.7|106.4|
72508220|NCT01345786|144547732|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Acceptance criteria of 80 - 125% were used for bioequivalence evaluations (bioequivalence concluded when 90% confidence interval fully contained within acceptance criteria).|Ratio (Test/Ref %)|103.3||||||90.0|100.9|105.7|||||Commercial Batch Test / Phase 3 Batch Reference|Analysis for AUC last||105.7|100.9|
72508221|NCT01345786|144547732|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Acceptance criteria of 80 - 125% were used for bioequivalence evaluations (bioequivalence concluded when 90% confidence interval fully contained within acceptance criteria).|Ratio (Test/Ref %)|108.1||||||90.0|104.7|111.6|||||Commercial Batch Test / Phase 3 Batch Reference.|Analysis for AUC infinity||111.6|104.7|
72508222|NCT01345786|144547732|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Acceptance criteria of 80 - 125% were used for bioequivalence evaluations (bioequivalence concluded when 90% confidence interval fully contained within acceptance criteria).|Ratio (Test/Ref %)|103.1||||||90.0|100.5|105.8|||||Commercial Batch Test / Phase 3 Batch Reference|Analysis for AUC infinity||105.8|100.5|
72508223|NCT01345786|144547733|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Acceptance criteria of 80 - 125% were used for bioequivalence evaluations (bioequivalence concluded when 90% confidence interval fully contained within acceptance criteria).|Ratio (Test/Ref %)|101.5||||||90.0|96.7|106.4|||||Commercial Batch Test / Phase 3 Batch Reference.|||106.4|96.7|
72508224|NCT01345786|144547733|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Acceptance criteria of 80 - 125% were used for bioequivalence evaluations (bioequivalence concluded when 90% confidence interval fully contained within acceptance criteria).|Ratio (Test/Ref %)|101.3||||||90.0|98.1|104.7|||||"Commercial Batch Test / Phase 3 Batch Reference.~In addition to the participants/profiles excluded, 1 participant from the Phase 3 Batch Reference group did not contribute to this comparison."|||104.7|98.1|
72508225|NCT01929044|144547740|NON_INFERIORITY_OR_EQUIVALENCE|One-sided test relative to the non-inferiority margin of 1|Mean Difference (Final Values)|-0.42|STANDARD_ERROR_OF_MEAN|0.23|<|0.0001|TWO_SIDED|95.0|-0.88|0.04|||Mixed Models Analysis|Kenward-Roger approximation is used to estimate the denominator degrees of freedom. An unstructured covariance matrix is used.|REML-based repeated measures approach includes baseline pain intensity as continuous covariate, treatment, centre, time and treatment-time interaction as fixed effects. The difference was calculated as Buscopan minus 654-II.|Restricted maximum likelihood (REML) -repeated measures approach||0.04|-0.88|<0.0001
72508226|NCT01929044|144547740|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.42|STANDARD_ERROR_OF_MEAN|0.23||0.0743|TWO_SIDED|95.0|-0.88|0.04|||Mixed Models Analysis|Kenward-Roger approximation is used to estimate the denominator degrees of freedom. An unstructured covariance matrix is used.|REML-based repeated measures approach includes baseline pain intensity as continuous covariate, treatment, centre, time and treatment-time interaction as fixed effects. The difference was calculated as Buscopan minus 654-II.|||0.04|-0.88|0.0743
72508227|NCT01929044|144547741|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.31|STANDARD_ERROR_OF_MEAN|0.2||0.121|TWO_SIDED|95.0|-0.7|0.08|||Mixed Models Analysis|Kenward-Roger approximation is used to estimate the denominator degrees of freedom. An unstructured covariance matrix is used.|REML-based repeated measures approach includes baseline pain intensity as continuous covariate, treatment, centre, time and treatment-time interaction as fixed effects. The difference was calculated as Buscopan minus 654-II.|||0.08|-0.70|0.1210
72508228|NCT01929044|144547742|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.21||0.0658|TWO_SIDED|95.0|-0.82|0.03|||Mixed Models Analysis|Kenward-Roger approximation is used to estimate the denominator degrees of freedom. An unstructured covariance matrix is used.|REML-based repeated measures approach includes baseline pain intensity as continuous covariate, treatment, centre, time and treatment-time interaction as fixed effects. The difference was calculated as Buscopan minus 654-II.|||0.03|-0.82|0.0658
72508229|NCT01929044|144547743|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.46|STANDARD_ERROR_OF_MEAN|0.2||0.022|TWO_SIDED|95.0|-0.85|-0.07|||Mixed Models Analysis|Kenward-Roger approximation is used to estimate the denominator degrees of freedom. An unstructured covariance matrix is used.|REML-based repeated measures approach includes baseline pain intensity as continuous covariate, treatment, centre, time and treatment-time interaction as fixed effects. The difference was calculated as Buscopan minus 654-II.|||-0.07|-0.85|0.0220
72508230|NCT01929044|144547744|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.45|STANDARD_ERROR_OF_MEAN|0.18||0.0149|TWO_SIDED|95.0|-0.81|-0.09|||Mixed Models Analysis|Kenward-Roger approximation is used to estimate the denominator degrees of freedom. An unstructured covariance matrix is used.|REML-based repeated measures approach includes baseline pain intensity as continuous covariate, treatment, centre, time and treatment-time interaction as fixed effects. The difference was calculated as Buscopan minus 654-II.|||-0.09|-0.81|0.0149
72508231|NCT01929044|144547745|SUPERIORITY_OR_OTHER|||||||0.0113|||||||van Elteren test|The van Elteren test stratifying for centre (Cochran-Mantel-Haenszel test using modified ridit scores) was performed.||||||0.0113
72508232|NCT01929044|144547746|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.64||||0.0992|TWO_SIDED|95.0|0.37|1.09|||Regression, Logistic|A logistic regression model was used to evaluate the response with treatment as fixed effect and baseline pain intensity as continuous covariate.|Exact 95% confidence interval obtained by Clopper and Pearson approach.|||1.09|0.37|0.0992
72508233|NCT04436510|144547747|SUPERIORITY||Disease Rate Ratio|0.98|STANDARD_DEVIATION|0.118|||TWO_SIDED|95.0|0.769|1.237||Posterior probability that the disease rate ratio (DRR) is less than 1 (i.e. verdiperstat slowed progression) was 0.57467. NOTE: p-value is not provided for Bayesian model.|Bayesian shared-parameter model|A Bayesian shared-parameter model of change in disease severity as measured by ALSFRS-R total score and mortality.|"DDR \<1 imply slowing of disease progression by verdiperstat relative to placebo. Note: reported Confidence Interval is actually a Bayesian credible interval."||The model includes covariates for baseline use of edaravone, baseline use of riluzole, months since onset of symptoms, and pre-baseline slope of ALSFRS-R, and random effects for regimen and participant-specific slopes.|1.237|0.769|
72508234|NCT04436510|144547749|SUPERIORITY||Mean Difference (Net)|0.29|STANDARD_ERROR_OF_MEAN|2.054||0.8875|TWO_SIDED|95.0|-3.74|4.32|||Mixed Models Analysis|Covariates include baseline use of edaravone and riluzole, months since symptom onset, and pre-baseline ALSFRS-R slope.|Verdiperstat 24-week change from baseline relative to placebo 24-week change from baseline.|||4.32|-3.74|0.8875
72508235|NCT04436510|144547750|SUPERIORITY||Mean Difference (Net)|3.57|STANDARD_ERROR_OF_MEAN|3.848||0.3538|TWO_SIDED|95.0|-3.99|11.13|||Mixed Models Analysis|Covariates include baseline use of edaravone and riluzole, months since symptom onset, and pre-baseline ALSFRS-R slope.|Verdiperstat 24-week change from baseline relative to placebo 24-week change from baseline.|||11.13|-3.99|0.3538
72508236|NCT04436510|144547751|SUPERIORITY|||||||0.318|||||||Log Rank|||||||0.318
72508237|NCT00059215|144547768|SUPERIORITY_OR_OTHER|||||||0.933||95.0|||||Fisher Exact|||||||0.933
72508238|NCT00059215|144547768|SUPERIORITY_OR_OTHER|||||||0.59||95.0|||||Log Rank|||||||0.590
72508239|NCT00059215|144547769|SUPERIORITY_OR_OTHER|||||||0.945||95.0|||||Fisher Exact|||||||0.945
72566314|NCT02697773|144663262|SUPERIORITY||Least Square Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.09||0.0426|TWO_SIDED|95.0|-0.34|-0.01|||ANCOVA|||Week 12: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline PGA of osteoarthritis and baseline diary average pain as covariate, and study site as a random effect.||-0.01|-0.34|0.0426
72399348|NCT01086540|144305546|SUPERIORITY||Mean Difference (Final Values)|-7.9|STANDARD_ERROR_OF_MEAN|9.7||0.42|TWO_SIDED|||||P-values not adjusted for multiple comparisons.|Mixed Models Analysis|||A repeated measures mixed model was fit with percent change in PVR as the outcome and baseline PVR, treatment, visit week (actual observed week), and their interaction as predictors. Random intercepts and slopes were fit for each participant using an unstructured covariance structure for each treatment group.||||0.42
72399349|NCT01086540|144305551|SUPERIORITY|||||||0.17||||||P-values not adjusted for multiple comparisons.|Log Rank|||Kaplan-Meier curves for time to all-cause mortality were compared using a log-rank test.||||0.17
72399350|NCT01086540|144305552|SUPERIORITY|||||||0.35||||||P-values not adjusted for multiple comparisons.|Log Rank|||Kaplan-Meier curves for time to all-cause mortality were compared using a log-rank test.||||0.35
72399351|NCT03164928|144305553|SUPERIORITY||Least Squares Mean Difference|0.11||||0.68|TWO_SIDED|95.0|-0.45|0.673|||ANCOVA|||||0.673|-0.450|0.68
72399352|NCT03164928|144305554|SUPERIORITY||Least Squares Mean Difference|0.17||||0.34|TWO_SIDED|95.0|-0.194|0.542|||Repeated Measures Model|||Month 6||0.542|-0.194|0.34
72508240|NCT00059215|144547769|SUPERIORITY_OR_OTHER|||||||0.26||95.0|||||Log Rank|||||||0.260
72508241|NCT00059215|144547770|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|||||||1.0
72508242|NCT00059215|144547770|SUPERIORITY_OR_OTHER|||||||0.544||95.0|||||Log Rank|||||||0.544
72508243|NCT00059215|144547771|SUPERIORITY_OR_OTHER|||||||0.37||95.0|||||Fisher Exact|||||||0.370
72508244|NCT04985799|144547772|NON_INFERIORITY|For the sample size, a total of 143 participants, or 72 participants per group was needed, based on a 90% effectiveness for both slings 14% non-inferiority margin, 80% power, alpha of 0.05 and a 20% dropout rate.|Risk Difference (RD)|14.8||||0.04|TWO_SIDED|95.0|1.1|28.5|||Chi-squared|||||28.5|1.1|0.04
72399353|NCT03164928|144305554|SUPERIORITY||Least Squares Mean Difference|0.03||||0.93|TWO_SIDED|95.0|-0.609|0.661|||Repeated Measures Model|||Month 18||0.661|-0.609|0.93
72508245|NCT04985799|144547773|NON_INFERIORITY|For the sample size, a total of 143 participants, or 72 participants per group was needed, based on a 90% effectiveness for both slings 14% non-inferiority margin, 80% power, alpha of 0.05 and a 20% dropout rate.|Risk Difference (RD)|7.4||||0.29|TWO_SIDED|95.0|-6.2|21.1|||Chi-squared|||||21.1|-6.2|0.29
72508246|NCT04985799|144547775|SUPERIORITY|||||||0.11|||||||Chi-squared|||||||0.11
72566315|NCT02697773|144663262|SUPERIORITY||Least Square Mean Difference|-0.28|STANDARD_ERROR_OF_MEAN|0.09||0.0014|TWO_SIDED|95.0|-0.45|-0.11|||ANCOVA|||Week 12: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline PGA of osteoarthritis and baseline diary average pain as covariate, and study site as a random effect.||-0.11|-0.45|0.0014
72399354|NCT03164928|144305554|SUPERIORITY||Least Squares Mean Difference|0.11||||0.74|TWO_SIDED|95.0|-0.572|0.795|||Repeated Measures Model|||Month 24||0.795|-0.572|0.74
72566316|NCT02697773|144663264|SUPERIORITY||Odds Ratio (OR)|1.78||||0.0027|TWO_SIDED|95.0|1.22|2.61|||Regression, Logistic|||Week 2: Odds ratio and 95% confidence interval (CI) estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.61|1.22|0.0027
72399355|NCT03164928|144305554|SUPERIORITY||Least Squares Means Difference|-0.8||||0.12|TWO_SIDED|95.0|-1.848|0.239|||Repeated Measures Model|||Month 36||0.239|-1.848|0.12
72399356|NCT03164928|144305555|SUPERIORITY||Least Squares Mean Difference|-0.41||||0.19|TWO_SIDED|95.0|-1.05|0.223|||Repeated Measures Model|||Month 6 (Total Hip)||0.223|-1.050|0.19
72566317|NCT02697773|144663264|SUPERIORITY||Odds Ratio (OR)|1.98||||0.0004|TWO_SIDED|95.0|1.36|2.89|||Regression, Logistic|||Week 2: Odds ratio and 95% confidence interval (CI) estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.89|1.36|0.0004
72566318|NCT02697773|144663264|SUPERIORITY||Odds Ratio (OR)|1.98||||0.0008|TWO_SIDED|95.0|1.33|2.95|||Regression, Logistic|||Week 4: Odds ratio and 95% confidence interval (CI) estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.95|1.33|0.0008
72623247|NCT02743962|144777140|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.75|STANDARD_DEVIATION|2.12|||TWO_SIDED|||||||||The control group reported a mean reduction in O'Leary-Sant Insterstitial Cystitis Symptom Score from baseline to 6 weeks that met the MCID (4 points), whereas the TW group reported a reduction of 1.5 times the MCID (ISCI score change: control group 4.25, + 0.95, TW group 6.2, + 0.83). From 6 to 12 weeks the control group reported no change in ISCI score (0 + 0.95) whereas the Therapeutic Wand group ISCI socre reduced by 1.8 +1.73.||||
72623248|NCT02743962|144777140|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.25|STANDARD_DEVIATION|2.67|||TWO_SIDED|||||||||There was a small mean baseline ICPI score difference of 1.2 points between the groups (control group 10.5, +, TW group 11.2, + 2.68). Both groups reported a reduction in their ICPI scores from baseline to twelve weeks; the control group nearly met the minimal clinically important difference of 4 points and the TW group reported nearly twice the control group's score change (mean change control group 3.75, + 2.44, TW group 7, + 1.87).||||
72623249|NCT04330859|144777198|SUPERIORITY||Agresti-Caffo|95.0||||0.0543|TWO_SIDED|||||58.8 ± 7.2 (intervention) and 57.2 ± 11.2 (control; p = 0.0543)|t-test, 1 sided|||||||0.0543
72623250|NCT04770285|144777225|SUPERIORITY||Treatment Difference|-1.78||||0.0568|TWO_SIDED|95.0|-3.6|0.05|||MMRM|p-value was calculated by MMRM method with model terms: Treatment, trial center, visit, treatment by visit, and baseline by visit interaction.||||0.05|-3.60|0.0568
72623251|NCT04770285|144777226|SUPERIORITY||Treatment Difference|-0.77||||0.0705|TWO_SIDED|95.0|-1.61|0.07|||MMRM|p-value was calculated by MMRM method with model terms: Treatment, trial center, visit, treatment by visit, and baseline by visit interaction.||||0.07|-1.61|0.0705
72623252|NCT04770285|144777227|SUPERIORITY||Treatment Difference|-0.62||||0.3687|TWO_SIDED|95.0|-1.99|0.74||p-value was calculated by MMRM method with model terms: Treatment, trial center, visit, treatment by visit, and baseline by visit interaction.|MMRM|||Week 2||0.74|-1.99|0.3687
72623253|NCT04770285|144777227|SUPERIORITY||Treatment Difference|-1.45||||0.0828|TWO_SIDED|95.0|-3.1|0.19||p-value was calculated by MMRM method with model terms: Treatment, trial center, visit, treatment by visit, and baseline by visit interaction.|MMRM|||Week 4||0.19|-3.10|0.0828
72623254|NCT04770285|144777228|SUPERIORITY||Treatment Difference|-0.34||||0.3549|TWO_SIDED|95.0|-1.06|0.38||p-value was calculated by MMRM method with model terms: Treatment, trial center, visit, treatment by visit, and baseline by visit interaction.|MMRM|||Week 2||0.38|-1.06|0.3549
72623255|NCT04770285|144777228|SUPERIORITY||Treatment Difference|-0.28||||0.4948|TWO_SIDED|95.0|-1.09|0.53||p-value was calculated by MMRM method with model terms: Treatment, trial center, visit, treatment by visit, and baseline by visit interaction.|MMRM|||Week 4||0.53|-1.09|0.4948
72623256|NCT04770285|144777229|SUPERIORITY||Ratio of Response Rate|1.68||||0.142|TWO_SIDED|95.0|0.84|3.34||p-value was calculated by Cochran-Mantel-Haenzsel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 2||3.34|0.84|0.1420
72623257|NCT04770285|144777229|SUPERIORITY||Ratio of Response Rate|1.31||||0.2939|TWO_SIDED|95.0|0.79|2.16||p-value was calculated by Cochran-Mantel-Haenzsel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 4||2.16|0.79|0.2939
72623258|NCT04770285|144777229|SUPERIORITY||Ratio of Response Rate|1.38||||0.0884|TWO_SIDED|95.0|0.96|1.99||p-value was calculated by Cochran-Mantel-Haenzsel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 6||1.99|0.96|0.0884
72623259|NCT04770285|144777230|SUPERIORITY||Treatment Difference|-0.19||||0.0039|TWO_SIDED|95.0|-0.32|-0.06||p-value was calculated by MMRM method with model terms: Treatment, trial center, visit, treatment by visit, and baseline by visit interaction.|MMRM|||Week 2||-0.06|-0.32|0.0039
72623260|NCT04770285|144777230|SUPERIORITY||Treatment Difference|-0.32||||0.0003|TWO_SIDED|95.0|-0.5|-0.15||p-value was calculated by MMRM method with model terms: Treatment, trial center, visit, treatment by visit, and baseline by visit interaction.|MMRM|||Week 4||-0.15|-0.50|0.0003
72623261|NCT04770285|144777230|SUPERIORITY||Treatment Difference|-0.26||||0.0098|TWO_SIDED|95.0|-0.46|-0.06||p-value was calculated by MMRM method with model terms: Treatment, trial center, visit, treatment by visit, and baseline by visit interaction.|MMRM|||Week 6||-0.06|-0.46|0.0098
72623262|NCT04770285|144777231|SUPERIORITY||Treatment Difference|-1.02||||0.4463|TWO_SIDED|95.0|-3.66|1.61||p-value was calculated by ANCOVA model, with treatment and study center as main effects and baseline value as covariate.|ANCOVA|||||1.61|-3.66|0.4463
72623263|NCT04770285|144777232|SUPERIORITY||Treatment Difference|-1.29||||0.0102|TWO_SIDED|95.0|-2.28|-0.31||p-value was calculated by MMRM method with model terms: Treatment, trial center, visit, treatment by visit, and baseline by visit interaction.|MMRM|||Week 4||-0.31|-2.28|0.0102
72623264|NCT04770285|144777232|SUPERIORITY||Treatment Difference|-1.58||||0.0029|TWO_SIDED|95.0|-2.62|-0.54||p-value was calculated by MMRM method with model terms: Treatment, trial center, visit, treatment by visit, and baseline by visit interaction.|MMRM|||Week 6||-0.54|-2.62|0.0029
72399357|NCT03164928|144305555|SUPERIORITY||Least Squares Mean Difference|-0.06||||0.83|TWO_SIDED|95.0|-0.631|0.515|||Repeated Measures Model|||Month 12 (Total Hip)||0.515|-0.631|0.83
72399358|NCT03164928|144305555|SUPERIORITY||Least Squares Mean Difference|-0.27||||0.51|TWO_SIDED|95.0|-1.108|0.565|||Repeated Measures Model|||Month 18 (Total Hip)||0.565|-1.108|0.51
72399359|NCT03164928|144305555|SUPERIORITY||Least Squares Mean Difference|-0.18||||0.69|TWO_SIDED|95.0|-1.098|0.746|||Repeated Measures Model|||Month 24 (Total Hip)||0.746|-1.098|0.69
72399360|NCT03164928|144305555|SUPERIORITY||Least Squares Mean Difference|-0.09||||0.89|TWO_SIDED|95.0|-1.465|1.286|||Repeated Measures Model|||Month 36 (Total Hip)||1.286|-1.465|0.89
72508247|NCT01254604|144547779|NON_INFERIORITY_OR_EQUIVALENCE|The study was planned to enroll 248 subjects (124 per treatment group) to yield approximately 230 evaluable subjects (115 per treatment group). The study had power of 90% to test the primary hypothesis. The power and sample size were based on the following assumptions for treatment difference in change from baseline in IOP at Week 4: α = 0.025 (1-sided), Non-inferiority margin = 1.5 mmHg, True treatment difference = 0 mmHg, Standard deviation = 3.5 mmHg.|Difference in Least Squares Means|-1.7|||||TWO_SIDED|95.0|-2.6|-0.7|||ANCOVA|Analysis model includes terms for treatment, baseline IOP and ocular diagnosis (open-angle glaucoma or ocular hypertension)|Difference is tafluprost - timolol|The study hypothesis was that tafluprost is non-inferior to timolol with respect to change from baseline in diurnal IOP at Week 4 in participants with open-angle glaucoma or ocular hypertension. The study hypothesis would be met if the upper bound of the two-sided 95% confidence interval for the between-treatment difference in mean diurnal IOP change from baseline at Week4 (tafluprost - timolol) was ≤1.5 mmHg.||-0.7|-2.6|
72508248|NCT01254604|144547780|SUPERIORITY_OR_OTHER||Difference in percentage|19.5|||||TWO_SIDED|95.0|5.7|33.4|||Stratified Miettinen and Nurminen method|Participants were stratified by baseline IOP (\<26 mmHg or ≥26 mmHg at 0800 hours) and ocular diagnosis (open-angle glaucoma or ocular hypertension)|Between-group difference in percentage of participants with ≥25% reduction in IOP at Week 4 = percentage (tafluprost) - percentage (timolol)|||33.4|5.7|
72508249|NCT01254604|144547781|SUPERIORITY_OR_OTHER||Difference in percentage|-3.9|||||TWO_SIDED|95.0|-17.3|9.4|||Miettinen and Nurminen||Between-group difference in percentage of participants with an AE = percentage (tafluprost) - percentage (timolol)|||9.4|-17.3|
72508250|NCT01254604|144547782|SUPERIORITY_OR_OTHER||Difference in percentage|1.1|||||TWO_SIDED|95.0|-3.5|5.7|||Miettinen and Nurminen||Between-group difference in percentage of participants discontinued study drug due to an AE = percentage (tafluprost) - percentage (timolol)|||5.7|-3.5|
72508251|NCT03074162|144547783|EQUIVALENCE|The statistical model was an variance (ANOVA) on the logarithmic scale including fixed effects for sequence, subject nested within sequence, period and treatment for comparison of B with R.|Geometric Mean (gMean) Ratio (%)|45.54|STANDARD_ERROR_OF_MEAN|35.99|||TWO_SIDED|90.0|40.11|51.7|||ANOVA|Only the data for the comparison under investigation were included in the statistical analysis.|gMean Ratio=(B/R) \*100. Standard Error of the mean is actually intra-individual geometric coefficient of variation.|||51.70|40.11|
72508252|NCT03074162|144547783|EQUIVALENCE|The statistical model was an analysis of variance (ANOVA) on the logarithmic scale including fixed effects for sequence, subject nested within sequence, period and treatment for comparison of B with A.|Geometric Mean (gMean) Ratio (%)|85.56|STANDARD_ERROR_OF_MEAN|42.05|||TWO_SIDED|90.0|74.11|98.77|||ANOVA|Only the data for the comparison under investigation were included in the statistical analysis.|gMean Ratio=(B/A) \*100. Standard Error of the mean is actually intra-individual geometric coefficient of variation|||98.77|74.11|
72508253|NCT03074162|144547784|EQUIVALENCE|The statistical model was an analysis of variance (ANOVA) on the logarithmic scale including fixed effects for sequence, subject nested within sequence, period and treatment for comparison of B with R.|Geometric Mean (gMean) Ratio (%)|49.6|STANDARD_ERROR_OF_MEAN|38.13|||TWO_SIDED|90.0|43.39|56.71|||ANOVA|Only the data for the comparison under investigation were included in the statistical analysis.|gMean Ratio=(B/R) \*100. Standard Error of the mean is actually intra-individual geometric coefficient of variation.|||56.71|43.39|
72508254|NCT03074162|144547784|EQUIVALENCE|The statistical model was an analysis of variance (ANOVA) on the logarithmic scale including fixed effects for sequence, subject nested within sequence, period and treatment for comparison of B with A.|Geometric Mean (gMean) Ratio (%)|83.57|STANDARD_ERROR_OF_MEAN|72.45|||TWO_SIDED|90.0|66.33|105.31|||ANOVA|Only the data for the comparison under investigation were included in the statistical analysis.|gMean Ratio=(B/A) \*100. Standard Error of the mean is actually intra-individual geometric coefficient of variation|||105.31|66.33|
72508255|NCT01993329|144547788|SUPERIORITY||Geometric means ratio|1.108||||0.616|TWO_SIDED|95.0|0.734|1.673|||ANOVA||Analysis was based on an ANOVA model with log (base 2) PC20 methacholine challenge at each period as dependent variable, treatment and period as fixed effects and participant as random effect.|||1.673|0.734|0.616
72508256|NCT01993329|144547788|SUPERIORITY||Geometric means ratio|1.016||||0.939|TWO_SIDED|95.0|0.673|1.534|||ANOVA||Analysis was based on an ANOVA model with log (base 2) PC20 methacholine challenge at each period as dependent variable, treatment and period as fixed effects and participant as random effect.|||1.534|0.673|0.939
72508257|NCT01993329|144547788|SUPERIORITY||Geometric means ratio|0.917||||0.671|TWO_SIDED|95.0|0.607|1.384|||ANOVA||Analysis was based on an ANOVA model with log (base 2) PC20 methacholine challenge at each period as dependent variable, treatment and period as fixed effects and participant as random effect.|||1.384|0.607|0.671
72508258|NCT01993329|144547789|SUPERIORITY||Mean Difference (Final Values)|-0.111||||0.066|TWO_SIDED|95.0|-0.23|0.008|||ANOVA||Analysis is based on an ANOVA model with minimum highest FEV1 after methacholine challenge at each period as dependent variable, treatment and period as fixed effects and participant as random effect.|||0.008|-0.230|0.066
72399361|NCT03164928|144305555|SUPERIORITY||Least Squares Mean Difference|-0.18||||0.64|TWO_SIDED|95.0|-0.969|0.614|||Repeated Measures Model|||Month 6 (Femoral Neck)||0.614|-0.969|0.64
72399362|NCT03164928|144305555|SUPERIORITY||Least Squares Mean Difference|0.1||||0.83|TWO_SIDED|95.0|-0.808|1.0|||Repeated Measures Model|||Month 12 (Femoral Neck)||1.000|-0.808|0.83
72399363|NCT03164928|144305555|SUPERIORITY||Least Squares Mean Difference|0.37||||0.48|TWO_SIDED|95.0|-0.697|1.442|||Repeated Measures Model|||Month 18 (Femoral Neck)||1.442|-0.697|0.48
72399364|NCT03164928|144305555|SUPERIORITY||Least Squares Mean Difference|0.11||||0.86|TWO_SIDED|95.0|-1.222|1.443|||Repeated Measures Model|||Month 24 (Femoral Neck)||1.443|-1.222|0.86
72508259|NCT01993329|144547789|SUPERIORITY||Mean Difference (Final Values)|-0.012||||0.843|TWO_SIDED|95.0|-0.131|0.107|||ANOVA||Analysis is based on an ANOVA model with minimum highest FEV1 after methacholine challenge at each period as dependent variable, treatment and period as fixed effects and participant as random effect|||0.107|-0.131|0.843
72508260|NCT01993329|144547789|SUPERIORITY||Mean Difference (Final Values)|-0.099||||0.098|TWO_SIDED|95.0|-0.218|0.02|||ANOVA||Analysis is based on an ANOVA model with minimum highest FEV1 after methacholine challenge at each period as dependent variable, treatment and period as fixed effects and participant as random effect|||0.020|-0.218|0.098
72508261|NCT03041116|144547790|SUPERIORITY||Difference in LS Mean|-0.1|STANDARD_ERROR_OF_MEAN|0.8|=|0.9115|TWO_SIDED|95.0|-1.69|1.51||p-value was derived from test of contrast between treatment effects using LSM estimate, adjusted for baseline score and age group from Type III analysis. The test of contrast at Week 24 was considered the primary comparison.|Mixed Models Analysis|||||1.51|-1.69|=0.9115
72508262|NCT03041116|144547792|SUPERIORITY||Difference in LS Mean|2.0|STANDARD_ERROR_OF_MEAN|1.38|=|0.1421|TWO_SIDED|95.0|-0.7|4.78||p-value was derived from the test of contrast between treatment effects using the LSM estimate, adjusted for baseline score and age group from the Type III analysis. The test of contrast at week 24 was considered the primary comparison.|Mixed Models Analysis|||||4.78|-0.7|=0.1421
72508263|NCT00903032|144547801|NON_INFERIORITY_OR_EQUIVALENCE|Previously provided||||||0.003|TWO_SIDED||||||Chi-squared|||Unpaired t tests were used to compare continuous variables, and χ2 testswere used to compare categorical variables across the intervention and usual care. We used a log-rank test to compare the hazardof first hospitalization for MI, revascularization, or death.We used a Wilcoxon rank sum test to compare PDCs between study arms. For all other outcomes, χ2 tests and t testswere used for comparisons, as appropriate.||||0.003
72508264|NCT00931892|144547843|OTHER|||||||0.67|||||||t-test, 2 sided|||||||0.670
72508265|NCT00931892|144547844|OTHER|||||||0.409|||||||t-test, 2 sided|||||||0.409
72508266|NCT00931892|144547845|OTHER|||||||0.387|||||||t-test, 2 sided|||||||0.387
72508267|NCT00931892|144547845|OTHER|||||||0.208|||||||t-test, 2 sided|||||||0.208
72508268|NCT00931892|144547846|SUPERIORITY|||||||0.01|||||||ANOVA|||P Value for IgA anti-tTG||||0.010
72508269|NCT00931892|144547846|SUPERIORITY|||||||0.036|||||||ANOVA|||P Value for IgA/IgG anti-DGP||||0.036
72508270|NCT00931892|144547846|SUPERIORITY|||||||0.013|||||||ANOVA|||P Value for IgA anti-tTG||||0.013
72508271|NCT00931892|144547846|SUPERIORITY|||||||0.006|||||||ANOVA|||P Value for IgA/IgG anti-DGP||||0.006
72508272|NCT00931892|144547848|OTHER|||||||0.05|||||||t-test, 2 sided|||P Value for Celiac Symptom Index (CSI) score for Day 3 of Gluten Challenge||||0.05
72508273|NCT00931892|144547848|OTHER|||||||0.02|||||||t-test, 2 sided|||P Value for Celiac Symptom Index (CSI) Score from baseline to Day 14||||0.020
72508274|NCT00931892|144547848|SUPERIORITY|||||||0.06|||||||ANOVA|||P Value for Celiac Symptom Index (CSI)score between high gluten group and low gluten group across study||||0.060
72399365|NCT03164928|144305555|SUPERIORITY||Least Squares Mean Difference|0.38||||0.66|TWO_SIDED|95.0|-1.378|2.13|||Repeated Measures Model|||Month 36 (Femoral Neck)||2.130|-1.378|0.66
72508275|NCT00931892|144547850|OTHER|||||||0.01|||||||t-test, 2 sided|||P Value for the Gastrointestinal Symptom Rating Scale (GSRS) on Day 3 of the Gluten Challenge||||0.01
72508276|NCT00931892|144547850|OTHER|||||||0.012|||||||t-test, 2 sided|||P Value for Gastrointestinal Symptom Rating Scale (GSRS) from baseline to Day 14 of Gluten Challenge||||0.012
72508277|NCT00931892|144547850|SUPERIORITY|||||||0.09|||||||ANOVA|||P Value for Gastrointestinal Symptom Rating Scale (GSRS) between high gluten group and low gluten group across study||||0.090
72508278|NCT01876732|144547852|SUPERIORITY_OR_OTHER|||||||0.047||||||"P- value for social function"|Wilcoxon signed-rank test|||||||0.047
72508279|NCT01876732|144547852|SUPERIORITY_OR_OTHER|||||||0.688||||||"P- value of  symptom/problem list "|Wilcoxon signed-rank test|||||||0.688
72508280|NCT01876732|144547852|SUPERIORITY_OR_OTHER|||||||0.772||||||"P- value of  effects of kidney disease "|Wilcoxon signed-rank test|||||||0.772
72508281|NCT01876732|144547852|SUPERIORITY_OR_OTHER|||||||0.301||||||"P-value of  burden of kidney disease "|Wilcoxon signed-rank test|||||||0.301
72508282|NCT01876732|144547852|SUPERIORITY_OR_OTHER|||||||0.25||||||"P-value of  work status "|Wilcoxon signed-rank test|||||||0.250
72508283|NCT01876732|144547852|SUPERIORITY_OR_OTHER|||||||0.895||||||"P-value of  cognitive function "|Wilcoxon signed-rank test|||||||0.895
72508284|NCT01876732|144547852|SUPERIORITY_OR_OTHER|||||||0.281||||||"P-value of  quality of social interaction "|Wilcoxon signed-rank test|||||||0.281
72508285|NCT01876732|144547852|SUPERIORITY_OR_OTHER|||||||1||||||"P-value of  sleep "|Wilcoxon signed-rank test|||||||1.00
72508286|NCT01876732|144547852|SUPERIORITY_OR_OTHER|||||||1||||||"P-value of  social support "|Wilcoxon signed-rank test|||||||1.00
72508287|NCT01876732|144547852|SUPERIORITY_OR_OTHER|||||||0.943||||||"P-value of  dialysis staff encouragement "|Wilcoxon signed-rank test|||||||0.943
72508288|NCT01876732|144547852|SUPERIORITY_OR_OTHER|||||||1||||||"P-value of  overall health "|Wilcoxon signed-rank test|||||||1.00
72508289|NCT01876732|144547852|SUPERIORITY_OR_OTHER|||||||0.09||||||"P-value of  patient satisfaction "|Wilcoxon signed-rank test|||||||0.090
72508290|NCT01876732|144547852|SUPERIORITY_OR_OTHER|||||||0.391||||||"P-value of  physical functioning "|Wilcoxon signed-rank test|||||||0.391
72508291|NCT01876732|144547852|SUPERIORITY_OR_OTHER|||||||0.438||||||"P-value of  role-physical "|Wilcoxon signed-rank test|||||||0.438
72508292|NCT01876732|144547852|SUPERIORITY_OR_OTHER|||||||0.424||||||"P-value of  pain "|Wilcoxon signed-rank test|||||||0.424
72508293|NCT01876732|144547852|SUPERIORITY_OR_OTHER|||||||0.169||||||"P-value of  general health "|Wilcoxon signed-rank test|||||||0.169
72508294|NCT01876732|144547852|SUPERIORITY_OR_OTHER|||||||0.858||||||"P-value of  emotional well-being "|Wilcoxon signed-rank test|||||||0.858
72508295|NCT01876732|144547852|SUPERIORITY_OR_OTHER|||||||0.156||||||"P-value of  role-emotional "|Wilcoxon signed-rank test|||||||0.156
72508296|NCT01876732|144547852|SUPERIORITY_OR_OTHER|||||||0.084||||||"P-value of  energy/fatigue "|Wilcoxon signed-rank test|||||||0.084
72476379|NCT00760474|144478557|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) Mean difference|-0.127||||0.2823|TWO_SIDED|95.0|-0.3704|0.1165||Significance was set at p \<0.05.|Mixed Models Analysis|Mixed-effect repeated measure model included participant as a random effect; treatment, visit as fixed effects.||L\_S2||0.1165|-0.3704|0.2823
72476380|NCT00760474|144478557|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) Mean difference|-0.105||||0.1369|TWO_SIDED|95.0|-0.2481|0.0378||Significance was set at p \<0.05.|Mixed Models Analysis|Mixed-effect repeated measure model included participant as a random effect; treatment, visit as fixed effects.||R\_DLPFC||0.0378|-0.2481|0.1369
72476381|NCT00760474|144478557|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) Mean difference|0.078||||0.2376|TWO_SIDED|95.0|-0.0573|0.2127||Significance was set at p \<0.05.|Mixed Models Analysis|Mixed-effect repeated measure model included participant as a random effect; treatment, visit as fixed effects.||R\_anIns||0.2127|-0.0573|0.2376
72476382|NCT00760474|144478557|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) Mean difference|-0.153||||0.0968|TWO_SIDED|95.0|-0.3365|0.0313||Significance was set at p \<0.05.|Mixed Models Analysis|Mixed-effect repeated measure model included participant as a random effect; treatment, visit as fixed effects.||R\_Amygdala||0.0313|-0.3365|0.0968
72476383|NCT00760474|144478557|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) Mean difference|0.023||||0.572|TWO_SIDED|95.0|-0.061|0.1062||Significance was set at p \<0.05.|Mixed Models Analysis|Mixed-effect repeated measure model included participant as a random effect; treatment, visit as fixed effects.||R\_BA23\_base||0.1062|-0.0610|0.5720
72476384|NCT00760474|144478557|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) Mean difference|-0.027||||0.5822|TWO_SIDED|95.0|-0.1303|0.0761||Significance was set at p \<0.05.|Mixed Models Analysis|Mixed-effect repeated measure model included participant as a random effect; treatment, visit as fixed effects.||R\_IPL\_base||0.0761|-0.1303|0.5822
72476385|NCT00760474|144478557|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) Mean difference|-0.044||||0.6851|TWO_SIDED|95.0|-0.2697|0.1824||Significance was set at p \<0.05.|Mixed Models Analysis|Mixed-effect repeated measure model included participant as a random effect; treatment, visit as fixed effects.||R\_Insula\_base||0.1824|-0.2697|0.6851
72476386|NCT00760474|144478557|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) Mean difference|-0.013||||0.8656|TWO_SIDED|95.0|-0.1699|0.1446||Significance was set at p \<0.05.|Mixed Models Analysis|Mixed-effect repeated measure model included participant as a random effect; treatment, visit as fixed effects.||R\_Mid Insula||0.1446|-0.1699|0.8656
72476387|NCT00760474|144478557|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) Mean difference|-0.094||||0.1562|TWO_SIDED|95.0|-0.2296|0.0407||Significance was set at p \<0.05.|Mixed Models Analysis|Mixed-effect repeated measure model included participant as a random effect; treatment, visit as fixed effects.||R\_Mid Front\_DLPFC||0.0407|-0.2296|0.1562
72476388|NCT00760474|144478557|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) Mean difference|-0.012||||0.7752|TWO_SIDED|95.0|-0.0991|0.0754||Significance was set at p \<0.05.|Mixed Models Analysis|Mixed-effect repeated measure model included participant as a random effect; treatment, visit as fixed effects.||R\_Mid Temporal Pole||0.0754|-0.0991|0.7752
72476389|NCT00760474|144478557|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) Mean difference|0.01||||0.9182|TWO_SIDED|95.0|-0.1912|0.2109||Significance was set at p \<0.05.|Mixed Models Analysis|Mixed-effect repeated measure model included participant as a random effect; treatment, visit as fixed effects.||R\_Orbito Front||0.2109|-0.1912|0.9182
72476390|NCT00760474|144478557|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) Mean difference|0.022||||0.6544|TWO_SIDED|95.0|-0.0829|0.1278||Significance was set at p \<0.05.|Mixed Models Analysis|Mixed-effect repeated measure model included participant as a random effect; treatment, visit as fixed effects.||L\_PAG||0.1278|-0.0829|0.6544
72476391|NCT00760474|144478557|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) Mean difference|0.087||||0.0813|TWO_SIDED|95.0|-0.0123|0.1863||Significance was set at p \<0.05.|Mixed Models Analysis|Mixed-effect repeated measure model included participant as a random effect; treatment, visit as fixed effects.||R\_pIns||0.1863|-0.0123|0.0813
72476392|NCT00760474|144478557|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) Mean difference|0.052||||0.4605|TWO_SIDED|95.0|-0.0956|0.2004||Significance was set at p \<0.05.|Mixed Models Analysis|Mixed-effect repeated measure model included participant as a random effect; treatment, visit as fixed effects.||R\_pIns||0.2004|-0.0956|0.4605
72476393|NCT00760474|144478557|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) Mean difference|-0.081||||0.3136|TWO_SIDED|95.0|-0.2484|0.0856||Significance was set at p \<0.05.|Mixed Models Analysis|Mixed-effect repeated measure model included participant as a random effect; treatment, visit as fixed effects.||R\_Posterior Cingulate||0.0856|-0.2484|0.3136
72476394|NCT00760474|144478557|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) Mean difference|0.0||||0.9929|TWO_SIDED|95.0|-0.0885|0.0893||Significance was set at p \<0.05.|Mixed Models Analysis|Mixed-effect repeated measure model included participant as a random effect; treatment, visit as fixed effects.||R\_Precuneus||0.0893|-0.0885|0.9929
72476395|NCT00760474|144478557|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) Mean difference|-0.002||||0.949|TWO_SIDED|95.0|-0.0815|0.0767||Significance was set at p \<0.05.|Mixed Models Analysis|Mixed-effect repeated measure model included participant as a random effect; treatment, visit as fixed effects.||R\_Precuneus\_base||0.0767|-0.0815|0.9490
72508297|NCT01876732|144547852|SUPERIORITY_OR_OTHER|||||||0.583||||||"P-value of  SF-12 physical composite "|Wilcoxon signed-rank test|||||||0.583
72476396|NCT00760474|144478557|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) Mean difference|-0.065||||0.5668|TWO_SIDED|95.0|-0.3019|0.1722||Significance was set at p \<0.05.|Mixed Models Analysis|Mixed-effect repeated measure model included participant as a random effect; treatment, visit as fixed effects.||Superior Temporal||0.1722|-0.3019|0.5668
72476397|NCT00760474|144478557|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) Mean difference|0.0||||0.9958|TWO_SIDED|95.0|-0.1398|0.1391||Significance was set at p \<0.05.|Mixed Models Analysis|Mixed-effect repeated measure model included participant as a random effect; treatment, visit as fixed effects.||R\_Premotor||0.1391|-0.1398|0.9958
72508298|NCT01876732|144547852|SUPERIORITY_OR_OTHER|||||||0.358||||||"p-value of  SF-12 mental composite "|Wilcoxon signed-rank test|||||||0.358
72508299|NCT02531373|144547857|EQUIVALENCE|Miettinen and Nurminen method|Risk Difference (RD)|-4.0|||||TWO_SIDED|95.0|-13.5|3.1||||||||3.1|-13.5|
72566319|NCT02697773|144663264|SUPERIORITY||Odds Ratio (OR)|2.04||||0.0004|TWO_SIDED|95.0|1.37|3.04|||Regression, Logistic|||Week 4: Odds ratio and 95% confidence interval (CI) estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.04|1.37|0.0004
72476398|NCT00760474|144478557|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) Mean difference|0.057||||0.3379|TWO_SIDED|95.0|-0.0659|0.1795||Significance was set at p \<0.05.|Mixed Models Analysis|Mixed-effect repeated measure model included participant as a random effect; treatment, visit as fixed effects.||R\_Putamen||0.1795|-0.0659|0.3379
72476399|NCT00760474|144478557|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) Mean difference|-0.085||||0.2186|TWO_SIDED|95.0|-0.2262|0.0565||Significance was set at p \<0.05.|Mixed Models Analysis|Mixed-effect repeated measure model included participant as a random effect; treatment, visit as fixed effects.||R\_S1||0.0565|-0.2262|0.2186
72476400|NCT00760474|144478557|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) Mean difference|-0.008||||0.8191|TWO_SIDED|95.0|-0.0843|0.0678||Significance was set at p \<0.05.|Mixed Models Analysis|Mixed-effect repeated measure model included participant as a random effect; treatment, visit as fixed effects.||R\_Thalamus||0.0678|-0.0843|0.8191
72476401|NCT00760474|144478557|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) Mean difference|0.012||||0.7647|TWO_SIDED|95.0|-0.0698|0.093||Significance was set at p \<0.05.|Mixed Models Analysis|Mixed-effect repeated measure model included participant as a random effect; treatment, visit as fixed effects.||Precuneus||0.0930|-0.0698|0.7647
72476402|NCT01011153|144478573|NON_INFERIORITY_OR_EQUIVALENCE|Sample sizes computed based on data from smaller studies provided 90% power for the comparison of sensitivity. Under the alternative hypothesis that the biopsy sensitivity of MelaFind would be 0.10 greater than the average biopsy/referral sensitivity of physicians (combined or separate), the probability that a 95% CI lies entirely above zero will be at least 90% when the standard error of the estimated difference is at most 0.0308.|Mean Difference (Final Values)|0.25|STANDARD_DEVIATION|0.03|<|0.0001|TWO_SIDED|95.0|0.18|0.32|||ANOVA|||Using True Positives/All Positives, sensitivity values were calculated for MelaFind as well as the average of the 110 dermatologists.||0.32|0.18|<0.0001
72476403|NCT01011153|144478574|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.26|STANDARD_DEVIATION|0.04|<|0.0001|TWO_SIDED|95.0|0.19|0.34|||ANOVA|||Sensitivity||0.34|0.19|<0.0001
72476404|NCT01011153|144478574|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.24|STANDARD_DEVIATION|0.04|<|0.0001|TWO_SIDED|95.0|0.16|0.31|||ANOVA|||Sensitivity||0.31|0.16|<0.0001
72476405|NCT01011153|144478574|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.26|STANDARD_DEVIATION|0.03|<|0.0001|TWO_SIDED|95.0|0.19|0.33|||ANOVA|||Sensitivity||0.33|0.19|<0.0001
72476406|NCT01011153|144478574|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.36|STANDARD_DEVIATION|0.05|<|0.0001|TWO_SIDED|95.0|-0.46|-0.25|||ANOVA|||Specificity||-0.25|-0.46|<0.0001
72476407|NCT01011153|144478574|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.42|STANDARD_DEVIATION|0.05|<|0.0001|TWO_SIDED|95.0|-0.53|-0.31|||ANOVA|||Specificity||-0.31|-0.53|<0.0001
72476408|NCT01011153|144478574|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.41|STANDARD_DEVIATION|0.05|<|0.0001|TWO_SIDED|95.0|-0.51|-0.3|||ANOVA|||Specificity||-0.30|-0.51|<0.0001
72476409|NCT01011153|144478575|SUPERIORITY_OR_OTHER||Kappa|0.313|STANDARD_ERROR_OF_MEAN|0.003||||0.0||||No comparison is being made.|ANOVA||There is no threshold level-this is a measurement of variability among responses provided by the participants.|||||
72476410|NCT01011153|144478575|SUPERIORITY_OR_OTHER||Kappa|0.276|STANDARD_ERROR_OF_MEAN|0.002||||0.0||||No comparison is being made|ANOVA||There is no threshold level-this is a measurement of variability among responses provided by the participants.|||||
72476411|NCT01011153|144478575|SUPERIORITY_OR_OTHER||Kappa|0.2|STANDARD_ERROR_OF_MEAN|0.003||||0.0||||No comparison is being made|ANOVA||There is no threshold level-this is a measurement of variability among responses provided by the participants.|||||
72476412|NCT01011153|144478575|SUPERIORITY_OR_OTHER||Kappa|0.256|STANDARD_ERROR_OF_MEAN|0.001||||0.0||||N/A - No comparison is being made|ANOVA||There is no threshold level-this is a measurement of variability among responses provided by the participants.|||||
72476413|NCT03014479|144478577|SUPERIORITY||Differences of Least Square Means|2.418||||0.2305|TWO_SIDED|95.0|-1.546|6.382|||ANCOVA||Trelagliptin - Daily DPP-4 inhibitors|||6.382|-1.546|0.2305
72476414|NCT03014479|144478578|SUPERIORITY||Differences of Least Square Means|1.938||||0.4536|TWO_SIDED|95.0|-3.15|7.027|||ANCOVA||Trelagliptin - Daily DPP-4 inhibitors|||7.027|-3.150|0.4536
72476415|NCT03014479|144478579|SUPERIORITY||Differences of Least Square Means|4.16||||0.0896|TWO_SIDED|95.0|-0.649|8.968|||ANCOVA||Trelagliptin - Daily DPP-4 inhibitors|||8.968|-0.649|0.0896
72476416|NCT03014479|144478580|SUPERIORITY||Differences of Least Square Means|-0.563||||0.8506|TWO_SIDED|95.0|-6.448|5.323|||ANCOVA||Trelagliptin - Daily DPP-4 inhibitors|||5.323|-6.448|0.8506
72476417|NCT03014479|144478581|SUPERIORITY||Differences of Least Square Means|2.696||||0.3533|TWO_SIDED|95.0|-3.018|8.41|||ANCOVA||Trelagliptin - Daily DPP-4 inhibitors|||8.410|-3.018|0.3533
72476418|NCT03014479|144478583|SUPERIORITY||Differences of Least Square Means|0.613||||0.5451|TWO_SIDED|95.0|-1.38|2.605|||ANCOVA||Trelagliptin - Daily DPP-4 inhibitors|||2.605|-1.380|0.5451
72476419|NCT00432666|144478636|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.97|STANDARD_ERROR_OF_MEAN|1.49|<|0.001|TWO_SIDED|95.0|1.9|8.3|||Regression, Logistic|||The null hypothesis was equality of the chance (OR = 1) for a clinically relevant treatment effect between incobotulinumtoxinA (Xeomin) and placebo at Week 4 for wrist flexors. Responders were defined as subjects with an improvement of at least 1 point in the Ashworth score compared with Baseline. The dependent variable was the response to treatment, the independent variables were treatment, Ashworth score at the Baseline Visit, pre-treated patient status, gender, age, BMI, and pooled sites.||8.30|1.90|<0.001
72476420|NCT02516332|144478726|OTHER|||||||0.038|||||||ANCOVA|||||||0.038
72476421|NCT02516332|144478726|OTHER|||||||0.002|||||||ANCOVA|||||||0.002
72476422|NCT02516332|144478731|OTHER|||||||0.011|||||||Regression, Linear|||||||0.011
72476423|NCT02516332|144478731|OTHER|||||||0.036|||||||Regression, Linear|||||||0.036
72476424|NCT02366468|144478735|NON_INFERIORITY|non-inferiority margin: -4 letters|Median Difference (Final Values)|-0.9||||0.002|TWO_SIDED|95.0|-3.04|1.27|||ANCOVA|including study treatment (DI, PRN) and center as factors and baseline BCVA as continuous covariate.||The primary objective was to demonstrate that the mean visit-averaged change from baseline of BCVA over month 1 to treatment completion for the DI arm was non-inferior to the PRN arm.||1.27|-3.04|0.002
72476425|NCT02366468|144478739|SUPERIORITY||Mean Difference (Final Values)|5.7||||0.62|TWO_SIDED|95.0|-17.1|28.56|||ANCOVA|containing the baseline values of the dependent variables as continuous covariates, and center and treatment as categorical covariates||||28.56|-17.10|0.620
72476426|NCT02366468|144478740|SUPERIORITY||Mean Difference (Final Values)|-1.5||||0.925|TWO_SIDED|95.0|-33.66|30.59|||ANCOVA|containing the baseline values of the dependent variables as continuous covariates, and center and treatment as categorical covariates||||30.59|-33.66|0.925
72476427|NCT04797650|144478748|SUPERIORITY||Risk Difference (RD)|0.31|STANDARD_ERROR_OF_MEAN|0.031|<|0.0001|TWO_SIDED|95.0|0.25|0.37||P-value was calculated by Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||||0.37|0.25|<0.0001
72476428|NCT04797650|144478748|SUPERIORITY||Risk Difference (RD)|0.36|STANDARD_ERROR_OF_MEAN|0.044|<|0.0001|TWO_SIDED|95.0|0.27|0.45||P-value was calculated by Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||||0.45|0.27|<0.0001
72476429|NCT04797650|144478749|SUPERIORITY||Risk Difference (RD)|0.38|STANDARD_ERROR_OF_MEAN|0.038|<|0.0001|TWO_SIDED|95.0|0.31|0.46||P-value was calculated by Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||Week 12||0.46|0.31|<0.0001
72476430|NCT04797650|144478749|SUPERIORITY||Risk Difference (RD)|0.36|STANDARD_ERROR_OF_MEAN|0.049|<|0.0001|TWO_SIDED|95.0|0.26|0.45||P-value was calculated by Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||Week 12||0.45|0.26|<0.0001
72476431|NCT04797650|144478749|SUPERIORITY||Risk Difference (RD)|0.37|STANDARD_ERROR_OF_MEAN|0.037|<|0.0001|TWO_SIDED|95.0|0.3|0.45||P-value was calculated by Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||Week 16||0.45|0.30|<0.0001
72476432|NCT04797650|144478749|SUPERIORITY||Risk Difference (RD)|0.4|STANDARD_ERROR_OF_MEAN|0.049|<|0.0001|TWO_SIDED|95.0|0.31|0.5||P-value was calculated by Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||Week 16||0.50|0.31|<0.0001
72476433|NCT04797650|144478749|SUPERIORITY||Risk Difference (RD)|0.39|STANDARD_ERROR_OF_MEAN|0.034|<|0.0001|TWO_SIDED|95.0|0.32|0.46||P-value was calculated by Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||Week 20||0.46|0.32|<0.0001
72476434|NCT04797650|144478749|SUPERIORITY||Risk Difference (RD)|0.5|STANDARD_ERROR_OF_MEAN|0.047|<|0.0001|TWO_SIDED|95.0|0.41|0.59||P-value was calculated by Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||Week 20||0.59|0.41|<0.0001
72476435|NCT04797650|144478749|SUPERIORITY||Risk Difference (RD)|0.45|STANDARD_ERROR_OF_MEAN|0.035|<|0.0001|TWO_SIDED|95.0|0.38|0.52||P-value was calculated by Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||Week 24||0.52|0.38|<0.0001
72476436|NCT04797650|144478749|SUPERIORITY||Risk Difference (RD)|0.49|STANDARD_ERROR_OF_MEAN|0.047|<|0.0001|TWO_SIDED|95.0|0.4|0.58||P-value was calculated by Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||Week 24||0.58|0.40|<0.0001
72476437|NCT04797650|144478750|SUPERIORITY||Risk Difference (RD)|0.0|STANDARD_ERROR_OF_MEAN|0.004||0.3175|TWO_SIDED|95.0|0.0|0.01||P-value was calculated by Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||Week 4||0.01|-0.00|0.3175
72476438|NCT04797650|144478750|SUPERIORITY||Risk Difference (RD)|0.02|STANDARD_ERROR_OF_MEAN|0.013||0.102|TWO_SIDED|95.0|0.0|0.05||P-value was calculated by Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||Week 8||0.05|-0.00|0.1020
72476439|NCT04797650|144478750|SUPERIORITY||Risk Difference (RD)|0.02|STANDARD_ERROR_OF_MEAN|0.016||0.3103|TWO_SIDED|95.0|-0.01|0.05||P-value was calculated by Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||Week 8||0.05|-0.01|0.3103
72476440|NCT04797650|144478750|SUPERIORITY||Risk Difference (RD)|0.1|STANDARD_ERROR_OF_MEAN|0.021|<|0.0001|TWO_SIDED|95.0|0.06|0.14||P-value was calculated by Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||Week 12||0.14|0.06|<0.0001
72476441|NCT04797650|144478750|SUPERIORITY||Risk Difference (RD)|0.12|STANDARD_ERROR_OF_MEAN|0.03|<|0.0001|TWO_SIDED|95.0|0.06|0.17||P-value was calculated by Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||Week 12||0.17|0.06|<0.0001
72476442|NCT04797650|144478750|SUPERIORITY||Risk Difference (RD)|0.19|STANDARD_ERROR_OF_MEAN|0.026|<|0.0001|TWO_SIDED|95.0|0.14|0.24||P-value was calculated by Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||Week 16||0.24|0.14|<0.0001
72508300|NCT02531373|144547857|EQUIVALENCE|Miettinen and Nurminen method|Risk Difference (RD)|-6.0|||||TWO_SIDED|95.0|-16.3|1.2||||||||1.2|-16.3|
72508301|NCT02531373|144547857|EQUIVALENCE|Miettinen and Nurminen method|Risk Difference (RD)|-3.9|||||TWO_SIDED|95.0|-13.3|3.2||||||||3.2|-13.3|
72476443|NCT04797650|144478750|SUPERIORITY||Risk Difference (RD)|0.2|STANDARD_ERROR_OF_MEAN|0.037|<|0.0001|TWO_SIDED|95.0|0.13|0.27||P-value was calculated by Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||Week 16||0.27|0.13|<0.0001
72476444|NCT04797650|144478750|SUPERIORITY||Risk Difference (RD)|0.23|STANDARD_ERROR_OF_MEAN|0.028|<|0.0001|TWO_SIDED|95.0|0.18|0.29||P-value was calculated by Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo|Mantel Haenszel|||Week 20||0.29|0.18|<0.0001
72476445|NCT04797650|144478750|SUPERIORITY||Risk Difference (RD)|0.27|STANDARD_ERROR_OF_MEAN|0.041|<|0.0001|TWO_SIDED|95.0|0.19|0.35||P-value was calculated by Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||Week 20||0.35|0.19|<0.0001
72476446|NCT04797650|144478751|SUPERIORITY||Least Square (LS) Mean Difference|-2.8|STANDARD_ERROR_OF_MEAN|0.97||0.0039|TWO_SIDED|95.0|-4.7|-0.9||P-value was calculated by mixed model repeated measures (MMRM) analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value.|MMRM|||Week 4||-0.9|-4.7|0.0039
72476447|NCT04797650|144478751|SUPERIORITY||LS Mean Difference|-3.4|STANDARD_ERROR_OF_MEAN|1.12||0.0027|TWO_SIDED|95.0|-5.6|-1.2||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value.|MMRM|||Week 4||-1.2|-5.6|0.0027
72476448|NCT04797650|144478751|SUPERIORITY||LS Mean Difference|-9.4|STANDARD_ERROR_OF_MEAN|2.15|<|0.0001|TWO_SIDED|95.0|-13.6|-5.1||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value.|MMRM|||Week 8||-5.1|-13.6|<0.0001
72476449|NCT04797650|144478751|SUPERIORITY||LS Mean Difference|-14.2|STANDARD_ERROR_OF_MEAN|2.47|<|0.0001|TWO_SIDED|95.0|-19.0|-9.3||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value.|MMRM|||Week 8||-9.3|-19|<0.0001
72476450|NCT04797650|144478751|SUPERIORITY||LS Mean Difference|-23.0|STANDARD_ERROR_OF_MEAN|2.92|<|0.0001|TWO_SIDED|95.0|-28.8|-17.3||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value.|MMRM|||Week 12||-17.3|-28.8|<0.0001
72476451|NCT04797650|144478751|SUPERIORITY||LS Mean Difference|-29.3|STANDARD_ERROR_OF_MEAN|3.36|<|0.0001|TWO_SIDED|95.0|-35.9|-22.7||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value.|MMRM|||Week 12||-22.7|-35.9|< 0.0001
72476452|NCT04797650|144478751|SUPERIORITY||LS Mean Difference|-34.8|STANDARD_ERROR_OF_MEAN|3.37|<|0.0001|TWO_SIDED|95.0|-41.4|-28.2||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value.|MMRM|||Week 16||-28.2|-41.4|< 0.0001
72476453|NCT04797650|144478751|SUPERIORITY||LS Mean Difference|-40.2|STANDARD_ERROR_OF_MEAN|3.86|<|0.0001|TWO_SIDED|95.0|-47.8|-32.6||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value.|MMRM|||Week 16||-32.6|-47.8|< 0.0001
72476454|NCT04797650|144478751|SUPERIORITY||LS Mean Difference|-38.7|STANDARD_ERROR_OF_MEAN|3.63|<|0.0001|TWO_SIDED|95.0|-45.9|-31.6||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value.|MMRM|||Week 20||-31.6|-45.9|< 0.0001
72476455|NCT04797650|144478751|SUPERIORITY||LS Mean Difference|-46.6|STANDARD_ERROR_OF_MEAN|4.17|<|0.0001|TWO_SIDED|95.0|-54.8|-38.4||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value.|MMRM|||Week 20||-38.4|-54.8|< 0.0001
72476456|NCT04797650|144478751|SUPERIORITY||LS Mean Difference|-45.9|STANDARD_ERROR_OF_MEAN|3.8|<|0.0001|TWO_SIDED|95.0|-53.4|-38.5||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value.|MMRM|||Week 24||-38.5|-53.4|< 0.0001
72476457|NCT04797650|144478751|SUPERIORITY||LS Mean Difference|-52.8|STANDARD_ERROR_OF_MEAN|4.36|<|0.0001|TWO_SIDED|95.0|-61.4|-44.2|||MMRM|||Week 24||-44.2|-61.4|< 0.0001
72476458|NCT04797650|144478752|SUPERIORITY||||||<|0.0001||||||P-value was calculated by cochran mantel haenszel (CMH) test stratified by baseline scalp hair loss (partial vs complete/near-complete) for responders in each treatment group compared to placebo.|Cochran-Mantel-Haenszel|||Week 12||||< 0.0001
72476459|NCT04797650|144478752|SUPERIORITY||||||<|0.0001||||||P-value was calculated by CMH test stratified by baseline scalp hair loss (partial vs complete/near-complete) for responders in each treatment group compared to placebo.|Cochran-Mantel-Haenszel|||Week 12||||< 0.0001
72476460|NCT04797650|144478752|SUPERIORITY||||||<|0.0001||||||P-value was calculated by CMH test stratified by baseline scalp hair loss (partial vs complete/near-complete) for responders in each treatment group compared to placebo.|Cochran-Mantel-Haenszel|||Week 16||||< 0.0001
72476461|NCT04797650|144478752|SUPERIORITY||||||<|0.0001||||||P-value was calculated by CMH test stratified by baseline scalp hair loss (partial vs complete/near-complete) for responders in each treatment group compared to placebo.|Cochran-Mantel-Haenszel|||Week 16||||< 0.0001
72476462|NCT04797650|144478752|SUPERIORITY||||||<|0.0001||||||P-value was calculated by CMH test stratified by baseline scalp hair loss (partial vs complete/near-complete) for responders in each treatment group compared to placebo|Cochran-Mantel-Haenszel|||Week 20||||< 0.0001
72476463|NCT04797650|144478752|SUPERIORITY||||||<|0.0001||||||P-value was calculated by CMH test stratified by baseline scalp hair loss (partial vs complete/near-complete) for responders in each treatment group compared to placebo.|Cochran-Mantel-Haenszel|||Week 20||||< 0.0001
72476464|NCT04797650|144478752|SUPERIORITY||||||<|0.0001||||||P-value was calculated by CMH test stratified by baseline scalp hair loss (partial vs complete/near-complete) for responders in each treatment group compared to placebo.|Cochran-Mantel-Haenszel|||Week 24||||< 0.0001
72508302|NCT02531373|144547857|EQUIVALENCE|Miettinen and Nurminen method|Risk Difference (RD)|-1.9|||||TWO_SIDED|95.0|-10.2|5.1||||||||5.1|-10.2|
72476465|NCT04797650|144478752|SUPERIORITY||||||<|0.0001||||||P-value was calculated by CMH test stratified by baseline scalp hair loss (partial vs complete/near-complete) for responders in each treatment group compared to placebo.|Cochran-Mantel-Haenszel|||Week 24||||< 0.0001
72508303|NCT02531373|144547858|EQUIVALENCE|Miettinen and Nurminen method|Risk Difference (RD)|0.0|||||TWO_SIDED|95.0|-6.9|7.2||||||||7.2|-6.9|
72508304|NCT02531373|144547858|EQUIVALENCE|Miettinen and Nurminen method|Risk Difference (RD)|0.0|||||TWO_SIDED|95.0|-6.9|7.2||||||||7.2|-6.9|
72508305|NCT02531373|144547858|EQUIVALENCE|Miettinen and Nurminen method|Risk Difference (RD)|0.0|||||TWO_SIDED|95.0|-6.9|7.1||||||||7.1|-6.9|
72476466|NCT04797650|144478753|SUPERIORITY||||||<|0.0001||||||P-value was calculated by CMH test stratified by baseline scalp hair loss (partial vs complete/near-complete) for responders in each treatment group compared to placebo.|Cochran-Mantel-Haenszel|||Week 12||||< 0.0001
72476467|NCT04797650|144478753|SUPERIORITY||||||<|0.0001||||||P-value was calculated by CMH test stratified by baseline scalp hair loss (partial vs complete/near-complete) for responders in each treatment group compared to placebo.|Cochran-Mantel-Haenszel|||Week 12||||< 0.0001
72476468|NCT04797650|144478753|SUPERIORITY||||||<|0.0001||||||P-value was calculated by CMH test stratified by baseline scalp hair loss (partial vs complete/near-complete) for responders in each treatment group compared to placebo.|Cochran-Mantel-Haenszel|||Week 16||||< 0.0001
72476469|NCT04797650|144478753|SUPERIORITY||||||<|0.0001||||||P-value was calculated by CMH test stratified by baseline scalp hair loss (partial vs complete/near-complete) for responders in each treatment group compared to placebo.|Cochran-Mantel-Haenszel|||Week 16||||< 0.0001
72476470|NCT04797650|144478753|SUPERIORITY||||||<|0.0001||||||P-value was calculated by CMH test stratified by baseline scalp hair loss (partial vs complete/near-complete) for responders in each treatment group compared to placebo.|Cochran-Mantel-Haenszel|||Week 20||||< 0.0001
72476471|NCT04797650|144478753|SUPERIORITY||||||<|0.0001||||||P-value was calculated by CMH test stratified by baseline scalp hair loss (partial vs complete/near-complete) for responders in each treatment group compared to placebo.|Cochran-Mantel-Haenszel|||Week 20||||< 0.0001
72476472|NCT04797650|144478753|SUPERIORITY||||||<|0.0001||||||P-value was calculated by CMH test stratified by baseline scalp hair loss (partial vs complete/near-complete) for responders in each treatment group compared to placebo.|Cochran-Mantel-Haenszel|||Week 24||||< 0.0001
72476473|NCT04797650|144478753|SUPERIORITY||||||<|0.0001||||||P-value was calculated by CMH test stratified by baseline scalp hair loss (partial vs complete/near-complete) for responders in each treatment group compared to placebo.|Cochran-Mantel-Haenszel|||Week 24||||< 0.0001
72476474|NCT04797650|144478754|SUPERIORITY||LS Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-1.5|-1.0||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Week 12||-1|-1.5|< 0.0001
72476475|NCT04797650|144478754|SUPERIORITY||LS Mean Difference|-1.4|STANDARD_ERROR_OF_MEAN|0.16|<|0.0001|TWO_SIDED|95.0|-1.7|-1.1||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Week 12||-1.1|-1.7|< 0.0001
72476476|NCT04797650|144478754|SUPERIORITY||LS Mean Difference|-1.6|STANDARD_ERROR_OF_MEAN|0.15|<|0.0001|TWO_SIDED|95.0|-1.9|-1.3||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Week 16||-1.3|-1.9|< 0.0001
72476477|NCT04797650|144478754|SUPERIORITY||LS Mean Difference|-1.8|STANDARD_ERROR_OF_MEAN|0.18|<|0.0001|TWO_SIDED|95.0|-2.2|-1.5||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Week 16||-1.5|-2.2|< 0.0001
72476478|NCT04797650|144478754|SUPERIORITY||LS Mean Difference|-1.7|STANDARD_ERROR_OF_MEAN|0.18|<|0.0001|TWO_SIDED|95.0|-2.0|-1.3||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Week 20||-1.3|-2|< 0.0001
72476479|NCT04797650|144478754|SUPERIORITY||LS Mean Difference|-2.1|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001|TWO_SIDED|95.0|-2.5|-1.7||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Week 20||-1.7|-2.5|< 0.0001
72476480|NCT04797650|144478754|SUPERIORITY||LS Mean Difference|-2.2|STANDARD_ERROR_OF_MEAN|0.19|<|0.0001|TWO_SIDED|95.0|-2.5|-1.8||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Week 24||-1.8|-2.5|< 0.0001
72476481|NCT04797650|144478754|SUPERIORITY||LS Mean Difference|-2.4|STANDARD_ERROR_OF_MEAN|0.22|<|0.0001|TWO_SIDED|95.0|-2.8|-2.0||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Week 24||-2|-2.8|< 0.0001
72476482|NCT04797650|144478755|SUPERIORITY||LS Mean Difference|-1.4|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001|TWO_SIDED|95.0|-1.8|-1.0||P-value was calculated by MMRM with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Week 12||-1|-1.8|< 0.0001
72476483|NCT04797650|144478755|SUPERIORITY||LS Mean Difference|-1.6|STANDARD_ERROR_OF_MEAN|0.23|<|0.0001|TWO_SIDED|95.0|-2.0|-1.1||P-value was calculated by MMRM with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Week 12||-1.1|-2|< 0.0001
72476484|NCT04797650|144478755|SUPERIORITY||LS Mean Difference|-1.6|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001|TWO_SIDED|95.0|-2.0|-1.2||P-value was calculated by MMRM with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Week 16||-1.2|-2|< 0.0001
72476485|NCT04797650|144478755|SUPERIORITY||LS Mean Difference|-1.8|STANDARD_ERROR_OF_MEAN|0.23|<|0.0001|TWO_SIDED|95.0|-2.3|-1.4||P-value was calculated by MMRM with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Week 16||-1.4|-2.3|< 0.0001
72476486|NCT04797650|144478755|SUPERIORITY||LS Mean Difference|-1.7|STANDARD_ERROR_OF_MEAN|0.21|<|0.0001|TWO_SIDED|95.0|-2.2|-1.3||P-value was calculated by MMRM with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Week 20||-1.3|-2.2|< 0.0001
72508306|NCT02531373|144547858|EQUIVALENCE|Miettinen and Nurminen method|Risk Difference (RD)|0.0|||||TWO_SIDED|95.0|-6.9|6.9||||||||6.9|-6.9|
72508307|NCT02531373|144547859|EQUIVALENCE|Miettinen and Nurminen method|Risk Difference (RD)|20.3||||0.029|TWO_SIDED|95.0|2.1|37.3|||Miettinen and Nurminen method|||||37.3|2.1|0.029
72508308|NCT02531373|144547859|EQUIVALENCE|Miettinen and Nurminen method|Risk Difference (RD)|22.3||||0.016|TWO_SIDED|95.0|4.3|39.1|||Miettinen and Nurminen method|||||39.1|4.3|0.016
72508309|NCT02531373|144547859|EQUIVALENCE|Miettinen and Nurminen method|Risk Difference (RD)|1.1||||0.908|TWO_SIDED|95.0|-17.7|19.9|||Miettinen and Nurminen method|||||19.9|-17.7|0.908
72476487|NCT04797650|144478755|SUPERIORITY||LS Mean Difference|-1.9|STANDARD_ERROR_OF_MEAN|0.24|<|0.0001|TWO_SIDED|95.0|-2.4|-1.5||P-value was calculated by MMRM with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Week 20||-1.5|-2.4|< 0.0001
72399366|NCT04949165|144305605|NON_INFERIORITY|The study employed a non-inferiority design with a non-inferiority margin of 1 g/dL for haemoglobin levels at 4 months, a 1-sided alpha level of 0.025, at least 85% power and under the assumption that the true difference in the means was 0.3 g/dL. The estimated sample size also allowed for up to 10% loss to follow- up or iron supplementation for those initially not requiring supplements, thus the sample size was 292.||||||0.025||||||Non-inferiority threshold of -1 g/dL for the lower bound of the 97.5% CI.|t-test, 1 sided|||||||0.025
72399367|NCT03033511|144305634|SUPERIORITY||Hazard Ratio (HR)|1.07||||0.537|TWO_SIDED|95.0|0.84|1.36||stratified log-rank test|Log Rank|||||1.36|0.84|0.537
72476488|NCT04797650|144478755|SUPERIORITY||LS Mean Difference|-2.1|STANDARD_ERROR_OF_MEAN|0.21|<|0.0001|TWO_SIDED|95.0|-2.5|-1.7||P-value was calculated by MMRM with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Week 24||-1.7|-2.5|< 0.0001
72476489|NCT04797650|144478755|SUPERIORITY||LS Mean Difference|-2.3|STANDARD_ERROR_OF_MEAN|0.24|<|0.0001|TWO_SIDED|95.0|-2.8|-1.8||P-value was calculated by MMRM with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Week 24||-1.8|-2.8|< 0.0001
72476490|NCT04797650|144478756|SUPERIORITY||Risk Difference (RD)|0.09|STANDARD_ERROR_OF_MEAN|0.018|<|0.0001|TWO_SIDED|95.0|0.05|0.12||P-value was calculated by mantel-haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||75% Relative Reduction: Week 12||0.12|0.05|< 0.0001
72476491|NCT04797650|144478756|SUPERIORITY||Risk Difference (RD)|0.12|STANDARD_ERROR_OF_MEAN|0.029|<|0.0001|TWO_SIDED|95.0|0.06|0.17||P-value was calculated by mantel-haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||75% Relative Reduction: Week 12||0.17|0.06|< 0.0001
72476492|NCT04797650|144478756|SUPERIORITY||Risk Difference (RD)|0.33|STANDARD_ERROR_OF_MEAN|0.03|<|0.0001|TWO_SIDED|95.0|0.27|0.38||P-value was calculated by mantel-haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||75% Relative Reduction: Week 24||0.38|0.27|< 0.0001
72476493|NCT04797650|144478756|SUPERIORITY||Risk Difference (RD)|0.37|STANDARD_ERROR_OF_MEAN|0.043|<|0.0001|TWO_SIDED|95.0|0.28|0.45||P-value was calculated by mantel-haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||75% Relative Reduction: Week 24||0.45|0.28|< 0.0001
72476494|NCT04797650|144478756|SUPERIORITY||Risk Difference (RD)|0.02|STANDARD_ERROR_OF_MEAN|0.009||0.0409|TWO_SIDED|95.0|0.0|0.03||P-value was calculated by mantel-haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||90% Relative Reduction: Week 12||0.03|0.00|0.0409
72476495|NCT04797650|144478756|SUPERIORITY||Risk Difference (RD)|0.05|STANDARD_ERROR_OF_MEAN|0.019||0.012|TWO_SIDED|95.0|0.01|0.09||P-value was calculated by mantel-haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||90% Relative Reduction: Week 12||0.09|0.01|0.012
72476496|NCT04797650|144478756|SUPERIORITY||Risk Difference (RD)|0.21|STANDARD_ERROR_OF_MEAN|0.026|<|0.0001|TWO_SIDED|95.0|0.16|0.26||P-value was calculated by mantel-haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||90% Relative Reduction: Week 24||0.26|0.16|< 0.0001
72476497|NCT04797650|144478756|SUPERIORITY||Risk Difference (RD)|0.24|STANDARD_ERROR_OF_MEAN|0.038|<|0.0001|TWO_SIDED|95.0|0.16|0.31||P-value was calculated by mantel-haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||90% Relative Reduction: Week 24||0.31|0.16|< 0.0001
72476498|NCT04797650|144478757|SUPERIORITY||LS Mean Difference|1.0|STANDARD_ERROR_OF_MEAN|0.17|<|0.0001|TWO_SIDED|95.0|0.7|1.4||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Week 12||1.4|0.7|< 0.0001
72476499|NCT04797650|144478757|SUPERIORITY||LS Mean Difference|1.1|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001|TWO_SIDED|95.0|0.7|1.5||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Week 12||1.5|0.7|< 0.0001
72476500|NCT04797650|144478757|SUPERIORITY||LS Mean Difference|1.5|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001|TWO_SIDED|95.0|1.1|1.8||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Week 24||1.8|1.1|< 0.0001
72476501|NCT04797650|144478757|SUPERIORITY||LS Mean Difference|1.7|STANDARD_ERROR_OF_MEAN|0.23|<|0.0001|TWO_SIDED|95.0|1.3|2.2||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Week 24||2.2|1.3|< 0.0001
72476502|NCT04797650|144478758|SUPERIORITY||LS Mean Difference|1.1|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001|TWO_SIDED|95.0|0.7|1.5||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Week 12||1.5|0.7|< 0.0001
72476503|NCT04797650|144478758|SUPERIORITY||LS Mean Difference|1.2|STANDARD_ERROR_OF_MEAN|0.23|<|0.0001|TWO_SIDED|95.0|0.7|1.6||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Week 12||1.6|0.7|< 0.0001
72476504|NCT04797650|144478758|SUPERIORITY||LS Mean Difference|1.5|STANDARD_ERROR_OF_MEAN|0.24|<|0.0001|TWO_SIDED|95.0|1.0|2.0||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Week 24||2|1|< 0.0001
72508310|NCT02531373|144547859|EQUIVALENCE|Miettinen and Nurminen method|Risk Difference (RD)|23.1||||0.011|TWO_SIDED|95.0|5.4|39.6|||Miettinen and Nurminen method|||||39.6|5.4|0.011
72508311|NCT02531373|144547860|EQUIVALENCE|Miettinen and Nurminen method|Risk Difference (RD)|-0.5||||0.943|TWO_SIDED|95.0|-14.0|12.9|||Miettinen and Nurminen method|||||12.9|-14.0|0.943
72399368|NCT03033511|144305635|SUPERIORITY||Hazard Ratio (HR)|1.12||||0.237|TWO_SIDED|95.0|0.92|1.36||stratified log-rank test|Log Rank|||||1.36|0.92|0.237
72476505|NCT04797650|144478758|SUPERIORITY||LS Mean Difference|1.5|STANDARD_ERROR_OF_MEAN|0.29|<|0.0001|TWO_SIDED|95.0|1.0|2.1||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Week 24||2.1|1|< 0.0001
72508312|NCT02531373|144547860|EQUIVALENCE|Miettinen and Nurminen method|Risk Difference (RD)|-2.5||||0.711|TWO_SIDED|95.0|-16.4|11.2|||Miettinen and Nurminen method|||||11.2|-16.4|0.711
72508313|NCT02531373|144547860|EQUIVALENCE|Miettinen and Nurminen method|Risk Difference (RD)|3.7||||0.529|TWO_SIDED|95.0|-8.7|16.4|||Miettinen and Nurminen method|||||16.4|-8.7|0.529
72508314|NCT02531373|144547860|EQUIVALENCE|Miettinen and Nurminen method|Risk Difference (RD)|5.8||||0.298|TWO_SIDED|95.0|-5.8|18.2|||Miettinen and Nurminen method|||||18.2|-5.8|0.298
72508315|NCT02531373|144547861|EQUIVALENCE|2-sample t-test|Risk Ratio (RR)|0.82|||||TWO_SIDED|95.0|0.61|1.1||||||Serotype 1||1.10|0.61|
72508316|NCT02531373|144547861|EQUIVALENCE|2-sample t-test|Risk Ratio (RR)|1.77|||||TWO_SIDED|95.0|1.33|2.35||||||Serotype 3||2.35|1.33|
72508317|NCT02531373|144547861|EQUIVALENCE|2-sample t-test|Risk Ratio (RR)|1.28|||||TWO_SIDED|95.0|0.91|1.81||||||Serotype 4||1.81|0.91|
72508318|NCT02531373|144547861|EQUIVALENCE|2-sample t-test|Risk Ratio (RR)|0.95|||||TWO_SIDED|95.0|0.59|1.51||||||Serotype 5||1.51|0.59|
72508319|NCT02531373|144547861|EQUIVALENCE|2-sample t-test|Risk Ratio (RR)|0.5||||||95.0|0.29|0.86||||||Serotype 6A||0.86|0.29|
72508320|NCT02531373|144547861|EQUIVALENCE|2-sample t-test|Risk Ratio (RR)|1.11|||||TWO_SIDED|95.0|0.58|2.1||||||Serotype 6B||2.10|0.58|
72508321|NCT02531373|144547861|EQUIVALENCE|2-sample t-test|Risk Ratio (RR)|0.75|||||TWO_SIDED|95.0|0.55|1.03||||||Serotype 7F||1.03|0.55|
72508322|NCT02531373|144547861|EQUIVALENCE|2-sample t-test|Risk Ratio (RR)|1.14|||||TWO_SIDED|95.0|0.74|1.75||||||Serotype 9V||1.75|0.74|
72508323|NCT02531373|144547861|EQUIVALENCE|2-sample t-test|Risk Ratio (RR)|0.86|||||TWO_SIDED|95.0|0.58|1.27||||||Serotype 14||1.27|0.58|
72623265|NCT04770285|144777233|SUPERIORITY||Ratio of Response Rate|1.18||||0.5757|TWO_SIDED|95.0|0.65|2.16||p-value was calculated by Cochran-Mantel-Haenzsel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 2||2.16|0.65|0.5757
72399369|NCT03033511|144305636|SUPERIORITY||Least Squares (LS) Mean of Difference|-0.36|STANDARD_ERROR_OF_MEAN|1.39|||TWO_SIDED|95.0|-3.08|2.35||||||Change at Week 6||2.35|-3.08|
72508324|NCT02531373|144547861|EQUIVALENCE|2-sample t-test|Risk Ratio (RR)|0.63||||||95.0|0.43|0.92||||||Serotype 18C||0.92|0.43|
72508325|NCT02531373|144547861|EQUIVALENCE|2-sample t-test|Risk Ratio (RR)|0.9|||||TWO_SIDED|95.0|0.64|1.26||||||Serotype 19A||1.26|0.64|
72508326|NCT02531373|144547861|EQUIVALENCE|2-sample t-test|Risk Ratio (RR)|0.83|||||TWO_SIDED|95.0|0.62|1.11||||||Serotype 19F||1.11|0.62|
72508327|NCT02531373|144547861|EQUIVALENCE|2-sample t-test|Risk Ratio (RR)|81.47|||||TWO_SIDED|95.0|60.51|109.68||||||Serotype 22F (non-Prevnar serotype)||109.68|60.51|
72508328|NCT02531373|144547861|EQUIVALENCE|2-sample t-test|Risk Ratio (RR)|0.91|||||TWO_SIDED|95.0|0.56|1.47||||||Serotype 23F||1.47|0.56|
72508329|NCT02531373|144547861|EQUIVALENCE|2-sample t-test|Risk Ratio (RR)|22.23|||||TWO_SIDED|95.0|11.77|41.97||||||Serotype 33F (non-Prevnar serotype)||41.97|11.77|
72623266|NCT04770285|144777233|SUPERIORITY||Ratio of Response Rate|1.16||||0.5102|TWO_SIDED|95.0|0.75|1.78||p-value was calculated by Cochran-Mantel-Haenzsel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 4||1.78|0.75|0.5102
72623267|NCT04770285|144777233|SUPERIORITY||Ratio of Response Rate|1.15||||0.5342|TWO_SIDED|95.0|0.74|1.79||p-value was calculated by Cochran-Mantel-Haenzsel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 6||1.79|0.74|0.5342
72623268|NCT04770285|144777234|SUPERIORITY||Ratio of Response Rate|1.0|||||TWO_SIDED|95.0|0.82|1.22||||||Week 8||1.22|0.82|
72623269|NCT04770285|144777234|SUPERIORITY||Ratio of Response Rate|1.05|||||TWO_SIDED|95.0|0.88|1.25||||||Week 10||1.25|0.88|
72623270|NCT03766399|144777259|OTHER||LS means difference|-0.44||||0.9511|TWO_SIDED|90.0|-12.9|12.0|||Linear Mixed Model|||Comparison of Part 2a (MAD) Cohort 1 Vs Part 2a (MAD) Cohort 2||12.0|-12.9|0.9511
72508330|NCT02531373|144547861|EQUIVALENCE|2-sample t-test|Risk Ratio (RR)|0.92|||||TWO_SIDED|95.0|0.68|1.23||||||Serotype 1||1.23|0.68|
72508331|NCT02531373|144547861|EQUIVALENCE|2-sample t-test|Risk Ratio (RR)|2.11|||||TWO_SIDED|95.0|1.6|2.8||||||Serotype 3||2.80|1.60|
72508332|NCT02531373|144547861|EQUIVALENCE|2-sample t-test|Risk Ratio (RR)|1.15|||||TWO_SIDED|95.0|0.82|1.62||||||Serotype 4||1.62|0.82|
72508333|NCT02531373|144547861|EQUIVALENCE|2-sample t-test|Risk Ratio (RR)|0.83|||||TWO_SIDED|95.0|0.53|1.31||||||Serotype 5||1.31|0.53|
72508334|NCT02531373|144547861|EQUIVALENCE|2-sample t-test|Risk Ratio (RR)|0.54|||||TWO_SIDED|95.0|0.31|0.92||||||Serotype 6A||0.92|0.31|
72508335|NCT02531373|144547861|EQUIVALENCE|2-sample t-test|Risk Ratio (RR)|0.8|||||TWO_SIDED|95.0|0.42|1.5||||||Serotype 6B||1.50|0.42|
72508336|NCT02531373|144547861|EQUIVALENCE|2-sample t-test|Risk Ratio (RR)|0.97|||||TWO_SIDED|95.0|0.71|1.31||||||Serotype 7F||1.31|0.71|
72508337|NCT02531373|144547861|EQUIVALENCE|2-sample t-test|Risk Ratio (RR)|0.98|||||TWO_SIDED|95.0|0.64|1.49||||||Serotype 9V||1.49|0.64|
72508338|NCT02531373|144547861|EQUIVALENCE|2-sample t-test|Risk Ratio (RR)|0.93|||||TWO_SIDED|95.0|0.63|1.37||||||Serotype 14||1.37|0.63|
72508339|NCT02531373|144547861|EQUIVALENCE|2-sample t-test|Risk Ratio (RR)|0.79|||||TWO_SIDED|95.0|0.55|1.16||||||Serotype 18C||1.16|0.55|
72508340|NCT02531373|144547861|EQUIVALENCE|2-sample t-test|Risk Ratio (RR)|0.88|||||TWO_SIDED|95.0|0.63|1.22||||||Serotype 19A||1.22|0.63|
72508341|NCT02531373|144547861|EQUIVALENCE|2-sample t-test|Risk Ratio (RR)|1.08|||||TWO_SIDED|95.0|0.81|1.44||||||Serotype 19F||1.44|0.81|
72508342|NCT02531373|144547861|EQUIVALENCE|2-sample t-test|Risk Ratio (RR)|89.87|||||TWO_SIDED|95.0|67.02|120.51||||||Serotype 22F (non-Prevnar serotype)||120.51|67.02|
72508343|NCT02531373|144547861|EQUIVALENCE|2-sample t-test|Risk Ratio (RR)|0.98|||||TWO_SIDED|95.0|0.61|1.57||||||Serotype 23F||1.57|0.61|
72508344|NCT02531373|144547861|EQUIVALENCE|2-sample t-test|Risk Ratio (RR)|18.38|||||TWO_SIDED|95.0|9.82|34.41||||||Serotype 33F (non-Prevnar serotype)||34.41|9.82|
72508345|NCT00623467|144547886|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.03|STANDARD_DEVIATION|0.86|<|0.0001||||||for contrast enhancement|paired t-test|||||||< 0.0001
72508346|NCT00623467|144547886|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.85|STANDARD_DEVIATION|0.74|<|0.0001||||||for border delineation|paired t test|||||||< 0.0001
72508347|NCT00623467|144547886|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.53|STANDARD_DEVIATION|0.54|<|0.0001||||||for internal morphology|paired t test|||||||< 0.0001
72508348|NCT00623467|144547887|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.94|STANDARD_DEVIATION|0.8|<|0.0001||||||for contrast enhancement|paired t-test|||||||< 0.0001
72508349|NCT00623467|144547887|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.17|STANDARD_DEVIATION|0.94|<|0.0001||||||for border delineation|paired t test|||||||< 0.0001
72399370|NCT03033511|144305636|SUPERIORITY||LS Mean of Difference|-10.43|STANDARD_ERROR_OF_MEAN|2.12|||TWO_SIDED|95.0|-14.58|-6.29||||||Change at Week 12||-6.29|-14.58|
72476506|NCT04797650|144478759|SUPERIORITY||LS Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-1.4|-0.9||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value.|MMRM|||Week 12||-0.9|-1.4|< 0.0001
72508350|NCT00623467|144547887|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.08|STANDARD_DEVIATION|0.74|<|0.0001||||||for internal morphology|paired t test|||||||< 0.0001
72508351|NCT00623467|144547888|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.93|STANDARD_DEVIATION|0.82|<|0.0001||||||for contrast enhancement|paired t-test|||||||<0.0001
72508352|NCT00623467|144547888|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.12|STANDARD_DEVIATION|0.74|<|0.0001||||||for border delineation|paired t test|||||||< 0.0001
72508353|NCT00623467|144547888|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.77|STANDARD_DEVIATION|0.57|<|0.0001||||||for internal morphology|paired t test|||||||< 0.0001
72508354|NCT00623467|144547889|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.94|STANDARD_DEVIATION|0.77|<|0.0001||||||for contrast enhancement|paired t-test|||||||< 0.0001
72508355|NCT00623467|144547889|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.02|STANDARD_DEVIATION|0.71|<|0.0001||||||for border delineation|paired t test|||||||< 0.0001
72508356|NCT00623467|144547889|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.78|STANDARD_DEVIATION|0.53|<|0.0001||||||for internal morphology|paired t test|||||||< 0.0001
72399371|NCT03033511|144305636|SUPERIORITY||LS Mean of Difference|-27.67|STANDARD_ERROR_OF_MEAN|10.57|||TWO_SIDED|95.0|-46.19|-9.16||||||Change at Week 18||-9.16|-46.19|
72399372|NCT03033511|144305636|SUPERIORITY||LS Mean of Difference|-18.44|STANDARD_ERROR_OF_MEAN|9.99|||TWO_SIDED|95.0|-38.28|1.39||||||Change at Week 24||1.39|-38.28|
72399373|NCT03033511|144305636|SUPERIORITY||LS Mean of Difference|-22.0|STANDARD_ERROR_OF_MEAN|11.27|||TWO_SIDED|95.0|-42.63|-1.37||||||Change at Week 30||-1.37|-42.63|
72399374|NCT03033511|144305636|SUPERIORITY||LS Mean of Difference|0.0|||||TWO_SIDED|||||||||Change at Week 36||||
72399375|NCT03033511|144305636|SUPERIORITY||LS Mean of Difference|3.33|||||TWO_SIDED|||||||||Change at Week 42||||
72508357|NCT00623467|144547890|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.66|STANDARD_DEVIATION|5.31|||||||||||for BR1|||||
72508358|NCT00623467|144547890|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.17|STANDARD_DEVIATION|8.77|||||||||||for BR2|||||
72508359|NCT00623467|144547890|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.45|STANDARD_DEVIATION|4.2|||||||||||for BR3|||||
72508360|NCT00623467|144547890|NON_INFERIORITY_OR_EQUIVALENCE|noninferiority margin = -0.35|Mean Difference (Final Values)|0.32|STANDARD_DEVIATION|3.53|||TWO_SIDED|95.0|-0.07|0.704|||95% confidence interval for paired means||confidence interval provided for average reader, lower limit is compared to noninferiority margin|||0.704|-0.070|
72508361|NCT00623467|144547891|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.89|STANDARD_DEVIATION|0.68|<|0.0001||||||for border delineation|paired t-test|||||||< 0.0001
72508362|NCT00623467|144547891|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.74|STANDARD_DEVIATION|0.65|<|0.0001||||||for internal morphology|paired t test|||||||< 0.0001
72508363|NCT00623467|144547892|NON_INFERIORITY_OR_EQUIVALENCE|noninferiority margin = -0.35|Mean Difference (Final Values)|0.21|STANDARD_DEVIATION|1.6||||95.0|0.03|0.381|||||lower limit of the confidence interval is compared to the noninferiority margin|||0.381|0.030|
72508364|NCT00623467|144547893|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.59|STANDARD_DEVIATION|1.47|<|0.0001||||||for contrast enhancement|paired t-test|||||||< 0.0001
72508365|NCT00623467|144547893|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.75|STANDARD_DEVIATION|1.34|<|0.0001||||||for border delineation|paired t test|||||||< 0.0001
72508366|NCT00623467|144547893|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.45|STANDARD_DEVIATION|1.03|<|0.0001||||||for internal morphology|paired t test|||||||< 0.0001
72508367|NCT00623467|144547894|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.49|STANDARD_DEVIATION|1.38|<|0.0001||||||for contrast enhancement|paired t-test|||||||< 0.0001
72399376|NCT03033511|144305636|SUPERIORITY||LS Mean of Difference|-56.67|||||TWO_SIDED|||||||||Change at Week 48||||
72399377|NCT03033511|144305636|SUPERIORITY||LS Mean of Difference|0.0|||||TWO_SIDED|||||||||Change at Week 60||||
72399378|NCT03033511|144305636|SUPERIORITY||LS Mean of Difference|0.0|||||TWO_SIDED|||||||||Change at Week 66||||
72399379|NCT03033511|144305636|SUPERIORITY||LS Mean of Difference|0.0|||||TWO_SIDED|||||||||Change at Week 78||||
72399380|NCT03033511|144305636|SUPERIORITY||LS Mean of Difference|-9.17|STANDARD_ERROR_OF_MEAN|1.52|||TWO_SIDED|95.0|-12.16|-6.19||||||Change at Final Visit||-6.19|-12.16|
72476507|NCT04797650|144478759|SUPERIORITY||LS Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|0.15|<|0.0001|TWO_SIDED|95.0|-1.5|-0.9||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value.|MMRM|||Week 12||-0.9|-1.5|< 0.0001
72476508|NCT04797650|144478759|SUPERIORITY||LS Mean Difference|-1.4|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-1.6|-1.1||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value.|MMRM|||Week 16||-1.1|-1.6|< 0.0001
72508368|NCT00623467|144547894|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.12|STANDARD_DEVIATION|1.6|<|0.0001||||||for border delineation|paired t test|||||||< 0.0001
72508369|NCT00623467|144547894|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.02|STANDARD_DEVIATION|1.25|<|0.0001||||||for internal morphology|paired t test|||||||< 0.0001
72508370|NCT00623467|144547895|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.67|STANDARD_DEVIATION|1.39|<|0.0001||||||for contrast enhancement|paired t-test|||||||< 0.0001
72508371|NCT00623467|144547895|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.26|STANDARD_DEVIATION|1.3|<|0.0001||||||for border delineation|paired t test|||||||< 0.0001
72508372|NCT00623467|144547895|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.91|STANDARD_DEVIATION|1.02|<|0.0001||||||for internal morphology|paired t test|||||||< 0.0001
72508373|NCT00623467|144547896|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.51|STANDARD_DEVIATION|1.32|<|0.0001||||||for contrast enhancement|paired t-test|||||||< 0.0001
72508374|NCT00623467|144547896|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.0|STANDARD_DEVIATION|1.27|<|0.0001||||||for border delineation|paired t test|||||||< 0.0001
72508375|NCT00623467|144547896|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.77|STANDARD_DEVIATION|0.99|<|0.0001||||||for internal morphology|paired t test|||||||< 0.0001
72399381|NCT00894322|144305798|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.95|STANDARD_ERROR_OF_MEAN|0.269||0.0013|TWO_SIDED|95.0|-1.5|-0.4||Treatment group and HbA1c stratum at screening were factors. Placebo was reference group.|ANOVA|||||-0.40|-1.50|0.0013
72399382|NCT00894322|144305799|SUPERIORITY_OR_OTHER|||||||0.0033|||||||Cochran-Mantel-Haenszel|Adjusted for HbA1c strata at screening.||||||0.0033
72399383|NCT00894322|144305800|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.03|STANDARD_ERROR_OF_MEAN|0.835||0.2285|TWO_SIDED|95.0|-2.73|0.68|||ANOVA|treatment group and HbA1c stratum at screening were factors.||Least square mean (LS) mean, 95% confidence interval (CI) and p-value calculated for the changes in weight from baseline in participants in cohort 2 treated with exenatide with placebo as reference group.||0.68|-2.73|0.2285
72508376|NCT00623467|144547897|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.4|STANDARD_DEVIATION|0.48|<|0.0001||||||for contrast enhancement|paired t-test|||||||< 0.0001
72476509|NCT04797650|144478759|SUPERIORITY||LS Mean Difference|-1.5|STANDARD_ERROR_OF_MEAN|0.15|<|0.0001|TWO_SIDED|95.0|-1.8|-1.2||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value.|MMRM|||Week 16||-1.2|-1.8|< 0.0001
72476510|NCT04797650|144478759|SUPERIORITY||LS Mean Difference|-1.4|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-1.6|-1.1||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value.|MMRM|||Week 20||-1.1|-1.6|< 0.0001
72476511|NCT04797650|144478759|SUPERIORITY||LS Mean Difference|-1.7|STANDARD_ERROR_OF_MEAN|0.15|<|0.0001|TWO_SIDED|95.0|-2.0|-1.4||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value.|MMRM|||Week 20||-1.4|-2|< 0.0001
72476512|NCT04797650|144478759|SUPERIORITY||LS Mean Difference|-1.5|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-1.8|-1.3||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value.|MMRM|||Week 24||-1.3|-1.8|< 0.0001
72476513|NCT04797650|144478759|SUPERIORITY||LS Mean Difference|-1.8|STANDARD_ERROR_OF_MEAN|0.16|<|0.0001|TWO_SIDED|95.0|-2.1|-1.4||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value.|MMRM|||Week 24||-1.4|-2.1|< 0.0001
72476514|NCT04797650|144478760|SUPERIORITY||Risk Difference (RD)|0.34|STANDARD_ERROR_OF_MEAN|0.046|<|0.0001|TWO_SIDED|95.0|0.25|0.43||P-value was calculated by the Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||Week 12||0.43|0.25|< 0.0001
72476515|NCT04797650|144478760|SUPERIORITY||Risk Difference (RD)|0.43|STANDARD_ERROR_OF_MEAN|0.055|<|0.0001|TWO_SIDED|95.0|0.33|0.54||P-value was calculated by the Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||Week 12||0.54|0.33|< 0.0001
72476516|NCT04797650|144478760|SUPERIORITY||Risk Difference (RD)|0.43|STANDARD_ERROR_OF_MEAN|0.042|<|0.0001|TWO_SIDED|95.0|0.35|0.51||P-value was calculated by the Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||Week 16||0.51|0.35|< 0.0001
72476517|NCT04797650|144478760|SUPERIORITY||Risk Difference (RD)|0.47|STANDARD_ERROR_OF_MEAN|0.052|<|0.0001|TWO_SIDED|95.0|0.37|0.57||P-value was calculated by the Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||Week 16||0.57|0.37|< 0.0001
72508377|NCT00623467|144547897|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.93|STANDARD_DEVIATION|0.46|<|0.0001||||||for border delineation|paired t test|||||||<0.0001
72508378|NCT00623467|144547897|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.62|STANDARD_DEVIATION|0.32|<|0.0001||||||for internal morphology|paired t test|||||||< 0.0001
72508379|NCT00623467|144547898|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.35|STANDARD_DEVIATION|0.4|<|0.0001||||||for contrast enhancement|paired t-test|||||||< 0.0001
72399384|NCT00894322|144305801|SUPERIORITY_OR_OTHER||LS Mean Difference|-40.4|STANDARD_ERROR_OF_MEAN|12.8||0.0035|TWO_SIDED|95.0|-66.5|-14.3|||ANOVA|treatment group and HbA1c stratum at screening were factors.||||-14.3|-66.5|0.0035
72399385|NCT00951808|144305808|SUPERIORITY_OR_OTHER||optimal threshold level of sPLA2|48.0|STANDARD_DEVIATION|5.0|||TWO_SIDED|95.0|38.0|58.0|||||The optimal threshold level (TL) was determined to be the same for all analysis groups.|The optimal threshold level (TL), determined via receiver operating characteristic (ROC) curve analysis, maximizes the difference between the true positive rate (TPR) and the false positive rate (FPR). Since there is no corresponding analytic standard deviation (SD) for this value, we computed a robust SD based upon the interquartile range (IQR)/1.35 from a bootstrap sample of optimal TLs.||58|38|
72508380|NCT00623467|144547898|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.27|STANDARD_DEVIATION|0.38|<|0.0001||||||for border delineation|paired t test|||||||< 0.0001
72508381|NCT00623467|144547898|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.17|STANDARD_DEVIATION|0.34|<|0.0001||||||for internal morphology|paired t test|||||||< 0.0001
72399386|NCT00455429|144305812|SUPERIORITY_OR_OTHER|||||||0.6|||||||Cochran-Mantel-Haenszel|||||||0.600
72399387|NCT00455429|144305812|SUPERIORITY_OR_OTHER|||||||0.822|||||||Cochran-Mantel-Haenszel|||||||0.822
72476518|NCT04797650|144478760|SUPERIORITY||Risk Difference (RD)|0.42|STANDARD_ERROR_OF_MEAN|0.041|<|0.0001|TWO_SIDED|95.0|0.34|0.5||P-value was calculated by the Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||Week 20||0.5|0.34|< 0.0001
72476519|NCT04797650|144478760|SUPERIORITY||Risk Difference (RD)|0.54|STANDARD_ERROR_OF_MEAN|0.05|<|0.0001|TWO_SIDED|95.0|0.44|0.63||P-value was calculated by the Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||Week 20||0.63|0.44|< 0.0001
72476520|NCT04797650|144478760|SUPERIORITY||Risk Difference (RD)|0.44|STANDARD_ERROR_OF_MEAN|0.041|<|0.0001|TWO_SIDED|95.0|0.36|0.52||P-value was calculated by the Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||Week 24||0.52|0.36|< 0.0001
72476521|NCT04797650|144478760|SUPERIORITY||Risk Difference (RD)|0.52|STANDARD_ERROR_OF_MEAN|0.051|<|0.0001|TWO_SIDED|95.0|0.42|0.62||P-value was calculated by the Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||Week 24||0.62|0.42|< 0.0001
72476522|NCT04797650|144478761|SUPERIORITY||LS Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-1.2|-0.8||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Satisfied Thickness Hair Coverage: Week 12||-0.8|-1.2|< 0.0001
72476523|NCT04797650|144478761|SUPERIORITY||LS Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-1.4|-0.8||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Satisfied Thickness Hair Coverage: Week 12||-0.8|-1.4|< 0.0001
72476524|NCT04797650|144478761|SUPERIORITY||LS Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-1.3|-0.9||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Satisfied Thickness Hair Coverage: Week 16||-0.9|-1.3|< 0.0001
72476525|NCT04797650|144478761|SUPERIORITY||LS Mean Difference|-1.3|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-1.6|-1.1||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Satisfied Thickness Hair Coverage: Week 16||-1.1|-1.6|< 0.0001
72476526|NCT04797650|144478761|SUPERIORITY||LS Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-1.5|-1.0||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Satisfied Thickness Hair Coverage: Week 20||-1|-1.5|< 0.0001
72476527|NCT04797650|144478761|SUPERIORITY||LS Mean Difference|-1.6|STANDARD_ERROR_OF_MEAN|0.15|<|0.0001|TWO_SIDED|95.0|-1.9|-1.3||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Satisfied Thickness Hair Coverage: Week 20||-1.3|-1.9|< 0.0001
72476528|NCT04797650|144478761|SUPERIORITY||LS Mean Difference|-1.3|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-1.6|-1.1||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Satisfied Thickness Hair Coverage: Week 24||-1.1|-1.6|< 0.0001
72476529|NCT04797650|144478761|SUPERIORITY||LS Mean Difference|-1.5|STANDARD_ERROR_OF_MEAN|0.15|<|0.0001|TWO_SIDED|95.0|-1.8|-1.2||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Satisfied Thickness Hair Coverage: Week 24||-1.2|-1.8|< 0.0001
72476530|NCT04797650|144478761|SUPERIORITY||LS Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001|TWO_SIDED|95.0|-1.1|-0.7||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Satisfied evenness hair coverage: Week 12||-0.7|-1.1|< 0.0001
72476531|NCT04797650|144478761|SUPERIORITY||LS Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-1.3|-0.8||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Satisfied evenness hair coverage: Week 12||-0.8|-1.3|< 0.0001
72476532|NCT04797650|144478761|SUPERIORITY||LS Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001|TWO_SIDED|95.0|-1.2|-0.7||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Satisfied evenness hair coverage: Week 16||-0.7|-1.2|< 0.0001
72476533|NCT04797650|144478761|SUPERIORITY||LS Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-1.4|-0.9||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Satisfied evenness hair coverage: Week 16||-0.9|-1.4|< 0.0001
72476534|NCT04797650|144478761|SUPERIORITY||LS Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-1.3|-0.9||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Satisfied evenness hair coverage: Week 20||-0.9|-1.3|< 0.0001
72476535|NCT04797650|144478761|SUPERIORITY||LS Mean Difference|-1.4|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-1.6|-1.1||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Satisfied evenness hair coverage: Week 20||-1.1|-1.6|< 0.0001
72476536|NCT04797650|144478761|SUPERIORITY||LS Mean Difference|-1.3|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-1.5|-1.0||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Satisfied evenness hair coverage: Week 24||-1.0|-1.5|< 0.0001
72476537|NCT04797650|144478761|SUPERIORITY||LS Mean Difference|-1.5|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-1.8|-1.2||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Satisfied evenness hair coverage: Week 24||-1.2|-1.8|< 0.0001
72476538|NCT04797650|144478761|SUPERIORITY||LS Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-1.3|-0.8||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||How satisfied with your eyebrows: Week 12||-0.8|-1.3|< 0.0001
72476539|NCT04797650|144478761|SUPERIORITY||LS Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-1.4|-0.8||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||How satisfied with your eyebrows: Week 12||-0.8|-1.4|< 0.0001
72476540|NCT04797650|144478761|SUPERIORITY||LS Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-1.3|-0.8||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||How satisfied with your eyebrows: Week 16||-0.8|-1.3|< 0.0001
72476541|NCT04797650|144478761|SUPERIORITY||LS Mean Difference|-1.3|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-1.6|-1.0||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||How satisfied with your eyebrows: Week 16||-1|-1.6|< 0.0001
72476542|NCT04797650|144478761|SUPERIORITY||LS Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-1.5|-1.0||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||How satisfied with your eyebrows: Week 20||-1.0|-1.5|< 0.0001
72508382|NCT00623467|144547899|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.21|STANDARD_DEVIATION|0.37|<|0.0001||||||for contrast enhancement|paired t-test|||||||< 0.0001
72508383|NCT00623467|144547899|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.07|STANDARD_DEVIATION|0.45|<|0.0001||||||for border delineation|paired t test|||||||< 0.0001
72508384|NCT00623467|144547899|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.72|STANDARD_DEVIATION|0.3|<|0.0001||||||for internal morphology|paired t test|||||||<0.0001
72508385|NCT00623467|144547900|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.32|STANDARD_DEVIATION|0.34|<|0.0001||||||for contrast enhancement|paired t-test|||||||< 0.0001
72508386|NCT00623467|144547900|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.09|STANDARD_DEVIATION|0.3|<|0.0001||||||for border delineation|paired t test|||||||< 0.0001
72508387|NCT00623467|144547900|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.84|STANDARD_DEVIATION|0.22|<|0.0001||||||for internal morphology|paired t test|||||||< 0.0001
72508388|NCT00623467|144547902|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.82|STANDARD_DEVIATION|1.0|<|0.0001||||||for border delineation|paired t-test|||||||< 0.0001
72508389|NCT00623467|144547902|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.66|STANDARD_DEVIATION|0.9|<|0.0001||||||for internal morphology|paired t test|||||||< 0.0001
72508390|NCT00623467|144547903|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.99|STANDARD_DEVIATION|0.63|<|0.0001||||||for border delineation|paired t-test|||||||< 0.0001
72508391|NCT00623467|144547903|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.85|STANDARD_DEVIATION|0.64|<|0.0001||||||for internal morphology|paired t test|||||||< 0.0001
72508392|NCT00623467|144547904|SUPERIORITY_OR_OTHER||Risk Difference (RD)|9.4||||0.0002|||||||McNemar|||||||0.0002
72508393|NCT00623467|144547905|SUPERIORITY_OR_OTHER||Risk Difference (RD)|7.3||||0.0001|||||||McNemar|||||||0.0001
72508394|NCT00623467|144547906|SUPERIORITY_OR_OTHER||Risk Difference (RD)|5.0||||0.0285|||||||McNemar|||||||0.0285
72508395|NCT00623467|144547907|SUPERIORITY_OR_OTHER||Risk Difference (RD)|8.5||||0.0004|||||||McNemar|||||||0.0004
72508396|NCT00623467|144547908|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-12.5||||0.0588|||||||McNemar|||||||0.0588
72508397|NCT00623467|144547909|SUPERIORITY_OR_OTHER||Risk Difference (RD)|5.0||||0.0093|||||||McNemar|||||||0.0093
72508398|NCT00623467|144547910|SUPERIORITY_OR_OTHER||Risk Difference (RD)|20.6||||0.0003|||||||McNemar|||||||0.0003
72508399|NCT00623467|144547911|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.0||||1|||||||McNemar|||||||1.0000
72508400|NCT00623467|144547912|SUPERIORITY_OR_OTHER||Risk Difference (RD)|3.8||||0.0016|||||||McNemar|||||||0.0016
72508401|NCT00623467|144547913|SUPERIORITY_OR_OTHER||Risk Difference (RD)|7.9||||0.0253|||||||McNemar|||||||0.0253
72508402|NCT00623467|144547914|SUPERIORITY_OR_OTHER||Risk Difference (RD)|2.5||||0.0253|||||||McNemar|||||||0.0253
72508403|NCT00623467|144547915|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.44|STANDARD_DEVIATION|0.7|<|0.0001|||||||paired t-test|||||||< 0.0001
72508404|NCT00623467|144547916|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.84|STANDARD_DEVIATION|0.81|<|0.0001|||||||paired t-test|||||||< 0.0001
72508405|NCT02795988|144547930|SUPERIORITY||Cox proportional hazard regression model|0.603||||0.078|TWO_SIDED|80.0|0.38|0.957||1-sided p-value was calculated from Log-rank test stratified by factor tumor stage which used for randomization at screening.|Log Rank|||||0.957|0.380|0.078
72508406|NCT04705597|144547953|SUPERIORITY||Odds Ratio (OR)|1.366||||0.3312|TWO_SIDED|95.0|0.728|2.562|||Regression, Logistic|||||2.562|0.728|0.3312
72508407|NCT04705597|144547955|SUPERIORITY||Odds Ratio (OR)|0.574||||0.4561|TWO_SIDED|95.0|0.133|2.475|||Regression, Logistic|||Day 14||2.475|0.133|0.4561
72508408|NCT04705597|144547955|SUPERIORITY||Odds Ratio (OR)|0.521||||0.1559|TWO_SIDED|95.0|0.212|1.282|||Regression, Logistic|||Day 28||1.282|0.212|0.1559
72508409|NCT04705597|144547955|SUPERIORITY||Odds Ratio (OR)|0.498||||0.1293|TWO_SIDED|95.0|0.203|1.226|||Regression, Logistic|||Day 57||1.226|0.203|0.1293
72508410|NCT04705597|144547956|SUPERIORITY|||||||0.2687|||||||Log Rank|||Statistical analysis was only performed for Day 28. This is timeframe used for the primary endpoint||||0.2687
72508411|NCT04705597|144547957|SUPERIORITY|||||||0.3977|||||||Log Rank|||||||0.3977
72508412|NCT04705597|144547958|SUPERIORITY|||||||0.2229|||||||Log Rank|||||||0.2229
72508413|NCT04705597|144547959|SUPERIORITY||Odds Ratio (OR)|1.388||||0.2941|TWO_SIDED|95.0|0.752|2.561|||Regression, Logistic|||||2.561|0.752|0.2941
72508414|NCT04705597|144547960|SUPERIORITY|||||||0.3325|||||||Log Rank|||||||0.3325
72508415|NCT04705597|144547961|SUPERIORITY||Mean Difference (Final Values)|0.64||||0.0254|TWO_SIDED|95.0|0.08|1.2||Change at Day 14|ANCOVA|||||1.2|0.08|0.0254
72508416|NCT04705597|144547961|SUPERIORITY||Mean Difference (Final Values)|0.53||||0.1109|TWO_SIDED|95.0|-0.12|1.18|||ANCOVA|||Change at Day 28||1.18|-0.12|0.1109
72508417|NCT04705597|144547961|SUPERIORITY||Mean Difference (Final Values)|0.01||||0.864|TWO_SIDED|95.0|-0.1|0.12|||ANCOVA|||Change at Day 57||0.12|-0.10|0.8640
72508418|NCT04705597|144547962|SUPERIORITY||Odds Ratio (OR)|2.046||||0.0919|TWO_SIDED|95.0|0.89|4.706|||Regression, Logistic|||||4.706|0.89|0.0919
72508419|NCT04705597|144547963|SUPERIORITY||Mean Difference (Final Values)|3.83||||0.749|TWO_SIDED|95.0|-0.42|8.08|||ANCOVA|||||8.08|-0.42|0.749
72508420|NCT04705597|144547964|SUPERIORITY||Mean Difference (Final Values)|3.69||||0.1769|TWO_SIDED|95.0|-1.75|9.13|||ANCOVA|||||9.13|-1.75|0.1769
72508421|NCT04705597|144547965|SUPERIORITY||Odds Ratio (OR)|0.54||||0.2621|TWO_SIDED|95.0|0.184|1.586|||Regression, Logistic|||||1.586|0.184|0.2621
72508422|NCT04705597|144547966|SUPERIORITY||Mean Difference (Final Values)|2.81||||0.2265|TWO_SIDED|95.0|-1.76|7.37|||ANCOVA|||||7.37|-1.76|0.2265
72508423|NCT04705597|144547967|SUPERIORITY||Odds Ratio (OR)|1.223||||0.5497|TWO_SIDED|95.0|0.633|2.364|||Regression, Logistic|||||2.364|0.633|0.5497
72508424|NCT04705597|144547968|SUPERIORITY||Mean Difference (Final Values)|4.89||||0.1172|TWO_SIDED|95.0|-1.27|11.05|||ANCOVA|||||11.05|-1.27|0.1172
72508425|NCT04705597|144547969|SUPERIORITY||Odds Ratio (OR)|0.914||||0.853|TWO_SIDED|95.0|0.353|2.368|||Regression, Logistic|||||2.368|0.353|0.853
72508426|NCT04705597|144547970|SUPERIORITY||Mean Difference (Final Values)|3.16||||0.1991|TWO_SIDED|95.0|-1.86|8.18|||ANCOVA|||||8.18|-1.86|0.1991
72508427|NCT04705597|144547971|SUPERIORITY||Odds Ratio (OR)|4.103||||0.0166|TWO_SIDED|95.0|1.293|13.027|||Regression, Logistic|||||13.027|1.293|0.0166
72508428|NCT04705597|144547972|SUPERIORITY||Mean Difference (Final Values)|4.56||||0.1297|TWO_SIDED|95.0|-1.51|10.64|||ANCOVA|||||10.64|-1.51|0.1297
72508429|NCT04705597|144547973|SUPERIORITY||Mean Difference (Final Values)|-0.14||||0.1916|TWO_SIDED|95.0|-0.35|0.07|||ANCOVA|||Baseline||0.07|-0.35|0.1916
72623271|NCT03766399|144777259|OTHER||LS means difference|-7.87||||0.2849|TWO_SIDED|90.0|-20.3|4.59|||Linear Mixed Model|||Comparison of Part 2a (MAD) Cohort 2 Vs Part 2a (MAD) Placebo||4.59|-20.3|0.2849
72508430|NCT04705597|144547973|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.1097|TWO_SIDED|95.0|-0.44|0.05|||ANCOVA|||Treatment Day 2||0.05|-0.44|0.1097
72508431|NCT04705597|144547973|SUPERIORITY||Mean Difference (Final Values)|-0.33||||0.0276|TWO_SIDED|95.0|-0.63|-0.04|||ANCOVA|||Treatment Day 3||-0.04|-0.63|0.0276
72508432|NCT04705597|144547973|SUPERIORITY||Mean Difference (Final Values)|-0.36||||0.0463|TWO_SIDED|95.0|-0.71|-0.01|||ANCOVA|||Treatment Day 4||-0.01|-0.71|0.0463
72508433|NCT04705597|144547973|SUPERIORITY||Mean Difference (Final Values)|-0.33||||0.0969|TWO_SIDED|95.0|-0.71|0.06|||ANCOVA|||Treatment Day 5||0.06|-0.71|0.0969
72508434|NCT04705597|144547973|SUPERIORITY||Mean Difference (Final Values)|-0.16||||0.4367|TWO_SIDED|95.0|-0.57|0.25|||ANCOVA|||Treatment Day 6||0.25|-0.57|0.4367
72508435|NCT04705597|144547973|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.6685|TWO_SIDED|95.0|-0.54|0.35|||ANCOVA|||Treatment Day 7||0.35|-0.54|0.6685
72508436|NCT04705597|144547973|SUPERIORITY||Mean Difference (Final Values)|-0.28||||0.2287|TWO_SIDED|95.0|-0.73|0.18|||ANCOVA|||Treatment Day 8||0.18|-0.73|0.2287
72508437|NCT04705597|144547973|SUPERIORITY||Mean Difference (Final Values)|-0.43||||0.1061|TWO_SIDED|95.0|-0.96|0.09|||ANCOVA|||Treatment Day 9||0.09|-0.96|0.1061
72508438|NCT04705597|144547973|SUPERIORITY||Mean Difference (Final Values)|-0.54||||0.0415|TWO_SIDED|95.0|-1.06|-0.02|||ANCOVA|||Treatment Day 10||-0.02|-1.06|0.0415
72508439|NCT04705597|144547973|SUPERIORITY||Mean Difference (Final Values)|-0.44||||0.1236|TWO_SIDED|95.0|-1.0|0.12|||ANCOVA|||Treatment Day 11||0.12|-1.00|0.1236
72508440|NCT04705597|144547973|SUPERIORITY||Mean Difference (Final Values)|-0.71||||0.0097|TWO_SIDED|95.0|-1.23|-0.18|||ANCOVA|||Treatment Day 12||-0.18|-1.23|0.0097
72508441|NCT04705597|144547973|SUPERIORITY||Mean Difference (Final Values)|-0.57||||0.0157|TWO_SIDED|95.0|-1.02|-0.11|||ANCOVA|||Treatment Day 13||-0.11|-1.02|0.0157
72508442|NCT04705597|144547973|SUPERIORITY||Mean Difference (Final Values)|-0.84||||0.001|TWO_SIDED|95.0|-1.32|-0.36|||ANCOVA|||Treatment Day 14||-0.36|-1.32|0.0010
72508443|NCT04705597|144547973|SUPERIORITY||Mean Difference (Final Values)|-0.07||||0.644|TWO_SIDED|95.0|-0.4|0.25|||ANCOVA|||Time of Discharge Visit||0.25|-0.40|0.6440
72623272|NCT03766399|144777259|OTHER||LS means difference|-8.31||||0.2595|TWO_SIDED|90.0|-20.8|4.14|||Linear Mixed Model|||Comparison of Part 2a (MAD) Cohort 1 Vs Part 2a (MAD) Placebo||4.14|-20.8|0.2595
72508444|NCT04705597|144547973|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.9869|TWO_SIDED|95.0|-0.6|0.59|||ANCOVA|||Follow up Day 28||0.59|-0.60|0.9869
72508445|NCT04705597|144547974|SUPERIORITY||Mean Difference (Final Values)|1.69||||0.2399|TWO_SIDED|95.0|-1.14|4.52|||ANCOVA|||||4.52|-1.14|0.2399
72508446|NCT04705597|144547975|SUPERIORITY||Odds Ratio (OR)|0.869||||0.8081|TWO_SIDED|95.0|0.28|2.695|||Regression, Logistic|||||2.695|0.28|0.8081
72508447|NCT04705597|144547976|SUPERIORITY||Odds Ratio (OR)|1.436||||0.3193|TWO_SIDED|95.0|0.704|2.929|||Regression, Logistic|||||2.929|0.704|0.3193
72508448|NCT03691623|144547977|SUPERIORITY||LS Mean Difference|-588.08|||<|0.001|TWO_SIDED|95.0|-719.8|-456.35|||ANCOVA|||||-456.35|-719.8|< 0.001
72508449|NCT03691623|144547977|SUPERIORITY||LS Mean Difference|-564.63|||<|0.001|TWO_SIDED|95.0|-689.23|-440.02|||ANCOVA|||||-440.02|-689.23|< 0.001
72508450|NCT03691623|144547977|SUPERIORITY||LS Mean Difference|-716.08|||<|0.001|TWO_SIDED|95.0|-879.92|-552.24|||ANCOVA|||||-552.24|-879.92|< 0.001
72508451|NCT03691623|144547977|SUPERIORITY||LS Mean Difference|-736.23|||<|0.001|TWO_SIDED|95.0|-916.36|-556.11|||ANCOVA|||||-556.11|-916.36|< 0.001
72508452|NCT03691623|144547978|SUPERIORITY||LS Mean Difference|-355.91|||<|0.001|TWO_SIDED|95.0|-506.12|-205.69|||ANCOVA|||||-205.69|-506.12|< 0.001
72508453|NCT03691623|144547978|SUPERIORITY||LS Mean Difference|-326.64|||<|0.001|TWO_SIDED|95.0|-469.68|-183.6|||ANCOVA|||||-183.6|-469.68|< 0.001
72508454|NCT03691623|144547978|SUPERIORITY||LS Mean Difference|-313.98|||=|0.001|TWO_SIDED|95.0|-494.27|-133.69|||ANCOVA|||||-133.69|-494.27|= 0.001
72508455|NCT03691623|144547978|SUPERIORITY||LS Mean Difference|-312.73|||=|0.003|TWO_SIDED|95.0|-508.05|-117.4|||ANCOVA|||||-117.4|-508.05|= 0.003
72623273|NCT03766399|144777259|OTHER||LS means difference|-3.04||||0.3604|TWO_SIDED|90.0|-8.6|2.51|||Linear Mixed Model|||Comparison of Part 3a (DPI/PoM) Vs Part 3a (DPI/PoM) Placebo||2.51|-8.60|0.3604
72623274|NCT03766399|144777260|OTHER||LS means difference|-25.4||||0.7544|TWO_SIDED|90.0|-166.0|115.0|||Linear Mixed Model|||Comparison of Part 2a (MAD) Cohort 1 Vs Part 2a (MAD) Cohort 2||115|-166|0.7544
72623275|NCT03766399|144777260|OTHER||LS means difference|-73.3||||0.375|TWO_SIDED|90.0|-214.0|67.6|||Linear Mixed Model|||Comparison of Part 2a (MAD) Cohort 2 Vs Part 2a (MAD) Placebo||67.6|-214|0.3750
72399388|NCT00455429|144305812|SUPERIORITY_OR_OTHER|||||||0.656|||||||Cochran-Mantel-Haenszel|||||||0.656
72508456|NCT03691623|144547979|SUPERIORITY||LS Mean Difference|-3.7|||<|0.001|TWO_SIDED|95.0|-5.3|-2.0|||ANCOVA|||||-2|-5.3|< 0.001
72508457|NCT03691623|144547979|SUPERIORITY||LS Mean Difference|-3.9|||<|0.001|TWO_SIDED|95.0|-5.5|-2.4|||ANCOVA|||||-2.4|-5.5|< 0.001
72508458|NCT03691623|144547979|SUPERIORITY||LS Mean Difference|-3.0|||=|0.002|TWO_SIDED|95.0|-4.9|-1.2|||ANCOVA|||||-1.2|-4.9|= 0.002
72508459|NCT03691623|144547979|SUPERIORITY||LS Mean Difference|-2.9|||=|0.006|TWO_SIDED|95.0|-4.9|-0.9|||ANCOVA|||||-0.9|-4.9|= 0.006
72508460|NCT03691623|144547981|SUPERIORITY||LS Mean Difference|-0.82|||=|0.199|TWO_SIDED|95.0|-2.09|0.44|||ANCOVA|||||0.44|-2.09|= 0.199
72508461|NCT03691623|144547981|SUPERIORITY||LS Mean Difference|0.22|||=|0.714|TWO_SIDED|95.0|-0.98|1.43|||ANCOVA|||||1.43|-0.98|= 0.714
72508462|NCT03691623|144547981|SUPERIORITY||LS Mean Difference|-0.19|||=|0.844|TWO_SIDED|95.0|-2.15|1.77|||ANCOVA|||||1.77|-2.15|= 0.844
72508463|NCT03691623|144547981|SUPERIORITY||LS Mean Difference|-1.34|||=|0.21|TWO_SIDED|95.0|-3.46|0.79|||ANCOVA|||||0.79|-3.46|= 0.21
72508464|NCT03691623|144547982|SUPERIORITY||LS Mean Difference|-1.01|||=|0.145|TWO_SIDED|95.0|-2.37|0.36|||ANCOVA|||||0.36|-2.37|= 0.145
72508465|NCT03691623|144547982|SUPERIORITY||LS Mean Difference|-0.65|||=|0.352|TWO_SIDED|95.0|-2.03|0.73|||ANCOVA|||||0.73|-2.03|= 0.352
72508466|NCT03691623|144547982|SUPERIORITY||LS Mean Difference|-2.85|||=|0.002|TWO_SIDED|95.0|-4.55|-1.15|||ANCOVA|||||-1.15|-4.55|= 0.002
72508467|NCT03691623|144547982|SUPERIORITY||LS Mean Difference|-3.4|||<|0.001|TWO_SIDED|95.0|-5.19|-1.61|||ANCOVA|||||-1.61|-5.19|< 0.001
72508468|NCT03691623|144547983|SUPERIORITY||LS Mean Difference|-24.081|||<|0.001|TWO_SIDED|95.0|-36.554|-11.607|||ANCOVA|||||-11.607|-36.554|< 0.001
72476543|NCT04797650|144478761|SUPERIORITY||LS Mean Difference|-1.4|STANDARD_ERROR_OF_MEAN|0.15|<|0.0001|TWO_SIDED|95.0|-1.7|-1.1||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||How satisfied with your eyebrows: Week 20||-1.1|-1.7|< 0.0001
72476544|NCT04797650|144478761|SUPERIORITY||LS Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-1.5|-1.0||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||How satisfied with your eyebrows: Week 24||-1.0|-1.5|< 0.0001
72476545|NCT04797650|144478761|SUPERIORITY||LS Mean Difference|-1.5|STANDARD_ERROR_OF_MEAN|0.15|<|0.0001|TWO_SIDED|95.0|-1.8|-1.2||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||How satisfied with your eyebrows: Week 24||-1.2|-1.8|< 0.0001
72476546|NCT04797650|144478761|SUPERIORITY||LS Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-1.1|-0.7||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||How satisfied with your eyelashes: Week 12||-0.7|-1.1|< 0.0001
72476547|NCT04797650|144478761|SUPERIORITY||LS Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-1.2|-0.7||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||How satisfied with your eyelashes: Week 12||-0.7|-1.2|< 0.0001
72476548|NCT04797650|144478761|SUPERIORITY||LS Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-1.2|-0.7||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||How satisfied with your eyelashes: Week 16||-0.7|-1.2|< 0.0001
72476549|NCT04797650|144478761|SUPERIORITY||LS Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-1.3|-0.8||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||How satisfied with your eyelashes: Week 16||-0.8|-1.3|< 0.0001
72476550|NCT04797650|144478761|SUPERIORITY||LS Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-1.3|-0.8||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||How satisfied with your eyelashes: Week 20||-0.8|-1.3|< 0.0001
72476551|NCT04797650|144478761|SUPERIORITY||LS Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-1.5|-1.0||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||How satisfied with your eyelashes: Week 20||-1.0|-1.5|< 0.0001
72476552|NCT04797650|144478761|SUPERIORITY||LS Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-1.4|-0.9||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||How satisfied with your eyelashes: Week 24||-0.9|-1.4|< 0.0001
72476553|NCT04797650|144478761|SUPERIORITY||LS Mean Difference|-1.4|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-1.6|-1.1||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||How satisfied with your eyelashes: Week 24||-1.1|-1.6|< 0.0001
72476554|NCT04797650|144478762|SUPERIORITY||LS Mean Difference|0.5|STANDARD_ERROR_OF_MEAN|0.29||0.1206|TWO_SIDED|95.0|-0.1|1.0||P-value was calculated by analysis of covariance (ANCOVA) analysis with effects for treatment, visit, baseline SALT score, and baseline HADS value.|ANCOVA|||Anxiety||1.0|-0.1|0.1206
72476555|NCT04797650|144478762|SUPERIORITY||LS Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|0.34||0.5367|TWO_SIDED|95.0|-0.5|0.9||P-value was calculated by ANCOVA analysis with effects for treatment, visit, baseline SALT score, and baseline HADS value.|ANCOVA|||Anxiety||0.9|-0.5|0.5367
72476556|NCT04797650|144478762|SUPERIORITY||LS Mean Difference|0.8|STANDARD_ERROR_OF_MEAN|0.29||0.0064|TWO_SIDED|95.0|0.2|1.3||P-value was calculated by ANCOVA analysis with effects for treatment, visit, baseline SALT score, and baseline HADS value.|ANCOVA|||Depression||1.3|0.2|0.0064
72476557|NCT04797650|144478762|SUPERIORITY||LS Mean Difference|1.1|STANDARD_ERROR_OF_MEAN|0.33||0.0011|TWO_SIDED|95.0|0.4|1.7||P-value was calculated by ANCOVA analysis with effects for treatment, visit, baseline SALT score, and baseline HADS value.|ANCOVA|||Depression||1.7|0.4|0.0011
72476558|NCT04797650|144478763|SUPERIORITY||Risk Difference (RD)|0.24|STANDARD_ERROR_OF_MEAN|0.027|<|0.0001|TWO_SIDED|95.0|0.19|0.3||P-value was calculated by the Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||||0.3|0.19|< 0.0001
72476559|NCT04797650|144478763|SUPERIORITY||Risk Difference (RD)|0.25|STANDARD_ERROR_OF_MEAN|0.039|<|0.0001|TWO_SIDED|95.0|0.18|0.33||P-value was calculated by the Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||||0.33|0.18|< 0.0001
72476560|NCT00657020|144478776|SUPERIORITY_OR_OTHER|||||||0.296||95.0|||||ANOVA|||Region of Interest is left anterior insula.||||0.2960
72476561|NCT00657020|144478776|SUPERIORITY_OR_OTHER|||||||0.345||95.0|||||ANOVA|||Region of interest is left anterior insula.||||0.3450
72476562|NCT00657020|144478776|SUPERIORITY_OR_OTHER|||||||0.1192||95.0|||||ANOVA|||Region of interest is left anterior putamen.||||0.1192
72476563|NCT00657020|144478776|SUPERIORITY_OR_OTHER|||||||0.6639||95.0|||||ANOVA|||Region of interest is left anterior putamen.||||0.6639
72476564|NCT00657020|144478776|SUPERIORITY_OR_OTHER|||||||0.8295||95.0|||||ANOVA|||Region of interest is left dorsal anterior cingulate cortex.||||0.8295
72476565|NCT00657020|144478776|SUPERIORITY_OR_OTHER|||||||0.0078||95.0|||||ANOVA|||Region of interest is left dorsal anterior cingulate cortex.||||0.0078
72476566|NCT00657020|144478776|SUPERIORITY_OR_OTHER|||||||0.7153||95.0|||||ANOVA|||Region of interest is left dorsolateral pre-frontal cortex.||||0.7153
72476567|NCT00657020|144478776|SUPERIORITY_OR_OTHER|||||||0.8511||95.0|||||ANOVA|||Region of interest is left dorsolateral pre-frontal cortex||||0.8511
72508469|NCT03691623|144547983|SUPERIORITY||LS Mean Difference|-25.954|||<|0.001|TWO_SIDED|95.0|-37.695|-14.213|||ANCOVA|||||-14.213|-37.695|< 0.001
72476568|NCT00657020|144478776|SUPERIORITY_OR_OTHER|||||||0.4228||95.0|||||ANOVA|||Region of interest is left parietal cortex||||0.4228
72476569|NCT00657020|144478776|SUPERIORITY_OR_OTHER|||||||0.0611||95.0|||||ANOVA|||Region of interest is left parietal cortex||||0.0611
72508470|NCT03691623|144547983|SUPERIORITY||LS Mean Difference|-18.13|||<|0.001|TWO_SIDED|95.0|-27.176|-9.083|||ANCOVA|||||-9.083|-27.176|< 0.001
72476570|NCT00657020|144478776|SUPERIORITY_OR_OTHER|||||||0.9879||95.0|||||ANOVA|||Region of interest is left premotor cortex||||0.9879
72476571|NCT00657020|144478776|SUPERIORITY_OR_OTHER|||||||0.2065||95.0|||||ANOVA|||Region of interest is left premotor cortex||||0.2065
72476572|NCT00657020|144478776|SUPERIORITY_OR_OTHER|||||||0.1837||95.0|||||ANOVA|||Region of interest is left substantia nigra/ventral tegmental area||||0.1837
72476573|NCT00657020|144478776|SUPERIORITY_OR_OTHER|||||||0.8195||95.0|||||ANOVA|||Region of interest is left substantia nigra/ventral tegmental area||||0.8195
72476574|NCT00657020|144478776|SUPERIORITY_OR_OTHER|||||||0.642||95.0|||||ANOVA|||Region of interest is left thalamus||||0.6420
72476575|NCT00657020|144478776|SUPERIORITY_OR_OTHER|||||||0.7475||95.0|||||ANOVA|||Region of interest is left thalamus||||0.7475
72476576|NCT00657020|144478776|SUPERIORITY_OR_OTHER|||||||0.9049||95.0|||||ANOVA|||Region of interest is left visual cortex||||0.9049
72476577|NCT00657020|144478776|SUPERIORITY_OR_OTHER|||||||0.183||95.0|||||ANOVA|||Region of interest is left visual cortex||||0.1830
72476578|NCT00657020|144478776|SUPERIORITY_OR_OTHER|||||||0.5318||95.0|||||ANOVA|||Region of interest is right anterior insula||||0.5318
72476579|NCT00657020|144478776|SUPERIORITY_OR_OTHER|||||||0.9588||95.0|||||ANOVA|||Region of interest is right anterior insula||||0.9588
72476580|NCT00657020|144478776|SUPERIORITY_OR_OTHER|||||||0.7551||95.0|||||ANOVA|||Region of interest is right dorsal anterior cingulate cortex||||0.7551
72476581|NCT00657020|144478776|SUPERIORITY_OR_OTHER|||||||0.7895||95.0|||||ANOVA|||Region of interest is right dorsal anterior cingulate cortex||||0.7895
72476582|NCT00657020|144478776|SUPERIORITY_OR_OTHER|||||||0.9494||95.0|||||ANOVA|||Region of interest is right dorsolateral pre-frontal cortex||||0.9494
72476583|NCT00657020|144478776|SUPERIORITY_OR_OTHER|||||||0.4482||95.0|||||ANOVA|||Region of interest is right dorsolateral pre-frontal cortex||||0.4482
72476584|NCT00657020|144478776|SUPERIORITY_OR_OTHER|||||||0.9343||95.0|||||ANOVA|||Region of interest is right parietal cortex||||0.9343
72476585|NCT00657020|144478776|SUPERIORITY_OR_OTHER|||||||0.7711||95.0|||||ANOVA|||Region of interest is right parietal cortex||||0.7711
72476586|NCT00657020|144478776|SUPERIORITY_OR_OTHER|||||||0.4755||95.0|||||ANOVA|||Region of interest is right premotor cortex||||0.4755
72476587|NCT00657020|144478776|SUPERIORITY_OR_OTHER|||||||0.3982||95.0|||||ANOVA|||Region of interest is right premotor cortex||||0.3982
72476588|NCT00657020|144478776|SUPERIORITY_OR_OTHER|||||||0.4622||95.0|||||ANOVA|||Region of interest is right thalamus||||0.4622
72476589|NCT00657020|144478776|SUPERIORITY_OR_OTHER|||||||0.4604||95.0|||||ANOVA|||Region of interest is right thalamus||||0.4604
72476590|NCT00657020|144478776|SUPERIORITY_OR_OTHER|||||||0.2485||95.0|||||ANOVA|||Region of interest is right visual cortex||||0.2485
72476591|NCT00657020|144478776|SUPERIORITY_OR_OTHER|||||||0.1931||95.0|||||ANOVA|||Region of interest is right visual cortex||||0.1931
72476592|NCT00657020|144478777|SUPERIORITY_OR_OTHER|||||||0.4535||95.0|||||ANOVA|||Null hypothesis considered the response time of treatments in comparison to be equal.||||0.4535
72476593|NCT00657020|144478777|SUPERIORITY_OR_OTHER|||||||0.1811||95.0|||||ANOVA|||Null hypothesis considered the response time of treatments in comparison to be equal.||||0.1811
72476594|NCT00657020|144478778|SUPERIORITY_OR_OTHER|||||||0.6261||95.0|||||ANOVA|||Null hypothesis considered treatments in comparison to be equal.||||0.6261
72476595|NCT00657020|144478778|SUPERIORITY_OR_OTHER|||||||0.0106||95.0|||||ANOVA|||Null hypothesis considered treatments in comparison to be equal.||||0.0106
72476596|NCT00657020|144478779|SUPERIORITY_OR_OTHER|||||||0.5544||95.0|||||ANOVA|||Region of interest is left parietal cortex.||||0.5544
72476597|NCT00657020|144478779|SUPERIORITY_OR_OTHER|||||||0.6716||95.0|||||ANOVA|||Region of interest is left parietal cortex.||||0.6716
72476598|NCT00657020|144478779|SUPERIORITY_OR_OTHER|||||||0.7511||95.0|||||ANOVA|||Region of interest is left superior occipital cortex.||||0.7511
72476599|NCT00657020|144478779|SUPERIORITY_OR_OTHER|||||||0.7959||95.0|||||ANOVA|||Region of interest is left superior occipital cortex.||||0.7959
72476600|NCT00657020|144478779|SUPERIORITY_OR_OTHER|||||||0.6418||95.0|||||ANOVA|||Region of interest is left visual cortex.||||0.6418
72476601|NCT00657020|144478779|SUPERIORITY_OR_OTHER|||||||0.2205||95.0|||||ANOVA|||Region of interest is left visual cortex.||||0.2205
72476602|NCT00657020|144478779|SUPERIORITY_OR_OTHER|||||||0.5135||95.0|||||ANOVA|||Region of interest is right parietal cortex.||||0.5135
72476603|NCT00657020|144478779|SUPERIORITY_OR_OTHER|||||||0.9781||95.0|||||ANOVA|||Region of interest is right parietal cortex.||||0.9781
72476604|NCT00657020|144478779|SUPERIORITY_OR_OTHER|||||||0.3755||95.0|||||ANOVA|||Region of interest is right premotor cortex.||||0.3755
72476605|NCT00657020|144478779|SUPERIORITY_OR_OTHER|||||||0.2612||95.0|||||ANOVA|||Region of interest is right premotor cortex.||||0.2612
72476606|NCT00657020|144478779|SUPERIORITY_OR_OTHER|||||||0.8486||95.0|||||ANOVA|||Region of interest is right superior occipital cortex.||||0.8486
72476607|NCT00657020|144478779|SUPERIORITY_OR_OTHER|||||||0.8318||95.0|||||ANOVA|||Region of interest is right superior occipital cortex.||||0.8318
72476608|NCT00657020|144478779|SUPERIORITY_OR_OTHER|||||||0.7554||95.0|||||ANOVA|||Region of interest is right visual cortex.||||0.7554
72476609|NCT00657020|144478779|SUPERIORITY_OR_OTHER|||||||0.5421||95.0|||||ANOVA|||Region of interest is right visual cortex.||||0.5421
72476610|NCT00657020|144478780|SUPERIORITY_OR_OTHER|||||||0.1963||95.0|||||ANOVA|||Null hypothesis considered response time of treatments in comparison to be equal.||||0.1963
72476611|NCT00657020|144478780|SUPERIORITY_OR_OTHER|||||||0.0959||95.0|||||ANOVA|||Null hypothesis considered response time of treatments in comparison to be equal.||||0.0959
72476612|NCT00657020|144478781|SUPERIORITY_OR_OTHER|||||||0.54||95.0|||||ANOVA|||Null hypothesis considered treatments in comparison to be equal.||||0.5400
72476613|NCT00657020|144478781|SUPERIORITY_OR_OTHER|||||||0.18||95.0|||||ANOVA|||Null hypothesis considered the treatments in comparison to be equal.||||0.1800
72476614|NCT01144052|144478788|NON_INFERIORITY_OR_EQUIVALENCE|No statistical hypothesis tests for efficacy were performed as this was a pilot study serving to generate first data and hypotheses.||||||0.125||95.0|||||Log Rank|||||||0.125
72476615|NCT01144052|144478789|SUPERIORITY_OR_OTHER|||||||0.447||95.0|||||non-parametric|||||||0.447
72476616|NCT01144052|144478790|SUPERIORITY_OR_OTHER|||||||0.447|||||||non-parametric|||||||0.447
72476617|NCT01144052|144478791|SUPERIORITY_OR_OTHER|||||||0.206|||||||t-test, 2 sided|||||||0.206
72399389|NCT00455429|144305813|SUPERIORITY_OR_OTHER||LS Mean difference|-3.4|STANDARD_ERROR_OF_MEAN|2.63||0.427|TWO_SIDED|95.0|-9.7|2.9|||Dunnett-Hsu|||||2.90|-9.70|0.427
72399390|NCT00455429|144305813|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.3|STANDARD_ERROR_OF_MEAN|2.55||0.922|TWO_SIDED|95.0|-7.37|4.82|||Dunnett-Hsu|||||4.82|-7.37|0.922
72399391|NCT00455429|144305813|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|2.24||0.919|TWO_SIDED|95.0|-6.49|4.21|||Dunnett-Hsu|||||4.21|-6.49|0.919
72399392|NCT00455429|144305814|SUPERIORITY_OR_OTHER||LS Mean difference|3.7|STANDARD_ERROR_OF_MEAN|8.15||0.941|TWO_SIDED|95.0|-15.83|23.18|||Dunnett-Hsu|||||23.18|-15.83|0.941
72399393|NCT00455429|144305814|SUPERIORITY_OR_OTHER||LS Mean Difference|14.2|STANDARD_ERROR_OF_MEAN|8.07||0.196|TWO_SIDED|95.0|-5.12|33.52|||Dunnett-Hsu|||||33.52|-5.12|0.196
72476618|NCT01144052|144478793|NON_INFERIORITY_OR_EQUIVALENCE|No statistical hypothesis tests for efficacy were performed, as this was pilot study serving to generate first data and hypotheses.||||||0.234||95.0|||||Wilcoxon (Mann-Whitney)|p-value refers to nT2L at month 12||||||0.234
72476619|NCT00105001|144478797|SUPERIORITY_OR_OTHER_LEGACY|||||||0.09|TWO_SIDED|||||Overall test of homogeneity among arms, reflecting events over the entire period of follow-up|Regression, Cox|||||||0.09
72476620|NCT00105001|144478797|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.69||||0.1|TWO_SIDED|95.0|0.4|1.1|||Regression, Cox||HR for Arm II relative to Arm I, reflecting events over the entire period of follow-u\[|||1.1|0.4|0.10
72476621|NCT00105001|144478797|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.62||||0.04|TWO_SIDED|95.0|0.6|1.0|||Regression, Cox||HR for Arm III relative to Arm I, reflecting events over the entire period of follow-up|||1.0|0.6|0.04
72476622|NCT00105001|144478798|SUPERIORITY_OR_OTHER_LEGACY|||||||0.55|TWO_SIDED|||||Overall test of homogeneity among arms, reflecting events over the entire period of follow-up|Regression, Cox|||||||0.55
72476623|NCT00105001|144478799|SUPERIORITY_OR_OTHER_LEGACY|||||||0.009|TWO_SIDED|||||Overall test of homogeneity among arms, reflecting events over the entire period of follow-up|Regression, Cox|||||||0.009
72476624|NCT00105001|144478799|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.86||||0.51|TWO_SIDED|95.0|0.5|1.4|||Regression, Cox||HR for Arm II relative to Arm I, reflecting events over the entire period of follow-up|||1.4|0.5|0.51
72476625|NCT00105001|144478799|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.47||||0.004|TWO_SIDED|95.0|0.3|0.8|||Regression, Cox||HR for Arm III relative to Arm I, reflecting events over the entire period of follow-up|||0.8|0.3|0.004
72476626|NCT00105001|144478800|SUPERIORITY_OR_OTHER_LEGACY|||||||0.93|TWO_SIDED|||||Overall test of homogeneity among arms, reflecting events over the entire period of follow-up|Regression, Cox|||||||0.93
72476627|NCT00105001|144478801|SUPERIORITY_OR_OTHER_LEGACY|||||||0.96|TWO_SIDED|||||Overall test of homogeneity among arms, reflecting events over the entire period of follow-up|Regression, Cox|||||||0.96
72476628|NCT01534689|144478837|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||t-test, 2 sided|||||||<0.0001
72476629|NCT01534689|144478838|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||t-test, 2 sided|||results at 12 weeks compared to baseline||||<0.0001
72476630|NCT02015455|144478839|SUPERIORITY||Percent Difference in Median|-0.7||||0.54|TWO_SIDED|95.0|-2.9|1.5|||Mixed Models Analysis|Adjusted for site, clinic size, age, sex, image modality, comorbidity, and site time trends. Random effects for clinic and provider.|Percent difference in median of the intervention group with respect to the control group.|||1.5|-2.9|0.54
72476631|NCT02015455|144478840|SUPERIORITY||Odds Ratio (OR)|0.95||||0.04|TWO_SIDED|95.0|0.91|1.0||A p-value \<0.05 was considered significant.|Mixed Models Analysis|Adjusted for site, clinic size, age, sex, image modality, comorbidity, prior opioid use, site time trends. Random effects for clinic and provider.|Odds ratio is for the intervention group with respect to the control group.|||1.00|0.91|0.04
72476632|NCT02015455|144478841|SUPERIORITY||Odds Ratio (OR)|0.95||||0.02|TWO_SIDED|95.0|0.9|0.99||The p-value is not adjusted for multiple comparisons.|Mixed Models Analysis|Adjusted for site, clinic size, age, sex, image modality, comorbidity, prior opioid use, site time trends. Random effects for clinic and provider.|Odds ratio is for the intervention group with respect to the control group.|||0.99|0.90|0.02
72476633|NCT02015455|144478842|SUPERIORITY||Odds Ratio (OR)|0.95||||0.02|TWO_SIDED|95.0|0.91|0.99||The p-value is not adjusted for multiple comparisons.|Mixed Models Analysis|Adjusted for site, clinic size, age, sex, image modality, comorbidity, prior opioid use, site time trends. Random effects for clinic and provider.|Odds ratio is for the intervention group with respect to the control group.|||0.99|0.91|0.02
72476634|NCT02015455|144478846|SUPERIORITY||Odds Ratio (OR)|0.99||||0.74|TWO_SIDED|95.0|0.91|1.07||Statistical significance defined as P\<0.05|Mixed Models Analysis|Adjusted for site, clinic size, age, sex, image modality, comorbidity, site time trends. Random effects for clinic and provider.|Odds ratio is for the intervention group with respect to the control group.|||1.07|0.91|0.74
72476635|NCT01177800|144478895|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Fisher Exact|||||||<0.001
72399394|NCT00455429|144305814|SUPERIORITY_OR_OTHER||LS Mean Difference|14.9|STANDARD_ERROR_OF_MEAN|7.08||0.096|TWO_SIDED|95.0|-2.0|31.86|||Dunnett-Hsu|||||31.86|-2.00|0.096
72399395|NCT00455429|144305815|SUPERIORITY_OR_OTHER|||||||0.46|||||||Regression, Logistic|||||||0.460
72399396|NCT00455429|144305815|SUPERIORITY_OR_OTHER|||||||0.479|||||||Regression, Logistic|||||||0.479
72399397|NCT00455429|144305815|SUPERIORITY_OR_OTHER|||||||0.462|||||||Regression, Logistic|||||||0.462
72399398|NCT00455429|144305816|SUPERIORITY_OR_OTHER|||||||0.363|||||||Regression, Logistic|||||||0.363
72399399|NCT00455429|144305816|SUPERIORITY_OR_OTHER|||||||0.968|||||||Regression, Logistic|||||||0.968
72399400|NCT00455429|144305816|SUPERIORITY_OR_OTHER|||||||0.501|||||||Regression, Logistic|||||||0.501
72399401|NCT00455429|144305817|SUPERIORITY_OR_OTHER|||||||0.333|||||||Regression, Logistic|||||||0.333
72399402|NCT00455429|144305817|SUPERIORITY_OR_OTHER|||||||0.527|||||||Regression, Logistic|||||||0.527
72399403|NCT00455429|144305817|SUPERIORITY_OR_OTHER|||||||0.353|||||||Regression, Logistic|||||||0.353
72399404|NCT00455429|144305818|SUPERIORITY_OR_OTHER|||||||0.631|||||||Regression, Logistic|||||||0.631
72399405|NCT00455429|144305818|SUPERIORITY_OR_OTHER|||||||0.523|||||||Regression, Logistic|||||||0.523
72399406|NCT00455429|144305818|SUPERIORITY_OR_OTHER|||||||0.101|||||||Regression, Logistic|||||||0.101
72399407|NCT00455429|144305819|SUPERIORITY_OR_OTHER|||||||0.429|||||||Regression, Logistic|||||||0.429
72399408|NCT00455429|144305819|SUPERIORITY_OR_OTHER|||||||0.206|||||||Regression, Logistic|||||||0.206
72508471|NCT03691623|144547983|SUPERIORITY||LS Mean Difference|-19.329|||<|0.001|TWO_SIDED|95.0|-29.106|-9.552|||ANCOVA|||||-9.552|-29.106|< 0.001
72476636|NCT01177800|144478896|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Non parametric ANOVA by van der Waerden|||Change at Week 10: p-value was calculated by Non parametric ANOVA by van der Waerden method.||||<0.001
72508472|NCT03691623|144547984|SUPERIORITY||LS Mean Difference|-2.1292|||<|0.001|TWO_SIDED|95.0|-2.8491|-1.4093|||ANCOVA|||||-1.4093|-2.8491|< 0.001
72508473|NCT03691623|144547984|SUPERIORITY||LS Mean Difference|-2.1129|||<|0.001|TWO_SIDED|95.0|-2.7938|-1.4319|||ANCOVA|||||-1.4319|-2.7938|< 0.001
72476637|NCT01177800|144478897|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Fisher Exact|||||||<0.001
72476638|NCT01177800|144478898|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Non parametric ANOVA by van der Waerden|||Change at Week 26: p-value was calculated by Non parametric ANOVA by van der Waerden method.||||<0.001
72476639|NCT03527550|144478900|SUPERIORITY|||||||0.95|||||||ANOVA|Repeated-measures ANOVA. P-value reflects the significance of the interaction term (condition x time).||A 2 (condition: TAU, TAU + cognitive training) x 2 (time) repeated-measures Analysis of Variance (ANOVA) was used to test change in negative urgency at time 1 (admission) and time 2 (discharge), and whether participants differ in their average change in negative urgency as a function of condition (interaction of condition X time; reported below).||||0.95
72476640|NCT03527550|144478901|SUPERIORITY|||||||0.64|||||||ANOVA|Repeated-measures ANOVA. P-value reflects the significance of the interaction term (condition x time).||A 2 (condition: TAU, TAU + cognitive training) x 2 (time) repeated-measures Analysis of Variance (ANOVA) was used to test change in positive urgency at time 1 (admission) and time 2 (discharge), and whether participants differ in their average change in positive urgency as a function of condition (interaction of condition X time; reported below).||||0.64
72476641|NCT03527550|144478902|SUPERIORITY|||||||0.91||||||Repeated-measures ANOVA. P-value reflects the significance of the interaction term (condition x time).|ANOVA|||A 2 (condition: TAU, TAU + cognitive training) x 2 (time) repeated-measures Analysis of Variance (ANOVA) was used to test change in stop-signal reaction time at time 1 (admission) and time 2 (discharge), and whether participants differ in their average change in stop-signal reaction time as a function of condition (interaction of condition X time; reported below).||||0.91
72476642|NCT03527550|144478906|SUPERIORITY|||||||0.24|||||||ANOVA|Repeated-measures ANOVA. P-value reflects the significance of the interaction term (condition x time).||A 2 (condition: TAU, TAU + cognitive training) x 2 (time) repeated-measures Analysis of Variance (ANOVA) was used to test change in distress intolerance at time 1 (admission) and time 2 (discharge), and whether participants differ in their average change in distress intolerance as a function of condition (interaction of condition X time; reported below).||||.24
72476643|NCT00911937|144478908|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.22|STANDARD_ERROR_OF_MEAN|0.08||0.003|TWO_SIDED|95.0|-0.37|-0.08||Statistical testing, two-sided, was done at alpha = 0.05 level.|ANCOVA|||Analysis of covariance (ANCOVA) model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.||-0.08|-0.37|0.0030
72476644|NCT00911937|144478909|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.13|STANDARD_ERROR_OF_MEAN|0.07||0.0772|TWO_SIDED|95.0|-0.27|0.01||Statistical testing, two-sided, was done at alpha = 0.05 level.|ANCOVA|||ANCOVA model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.||0.01|-0.27|0.0772
72476645|NCT00911937|144478910|SUPERIORITY_OR_OTHER|||||||0.0001|TWO_SIDED|||||Statistical testing, two-sided, was done at alpha = 0.05 level.|Ranked ANCOVA|Testing for percent change from baseline was only carried out for given endpoint if corresponding numeric change result was statistically significant.||Change at Week 12: Ranked ANCOVA model with terms for treatment and center with ranked baseline value as a covariate was used to calculate p-value.||||0.0001
72476646|NCT00911937|144478912|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.12|STANDARD_ERROR_OF_MEAN|0.07||0.0827|TWO_SIDED|95.0|-0.25|0.01||Statistical testing, two-sided, was done at alpha = 0.05 level.|ANCOVA|||Change at Week 4: ANCOVA model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.||0.01|-0.25|0.0827
72476647|NCT00911937|144478912|SUPERIORITY_OR_OTHER||Least Squares mean difference|-0.19|STANDARD_ERROR_OF_MEAN|0.07||0.0112|TWO_SIDED|95.0|-0.33|-0.04||Statistical testing, two-sided, was done at alpha = 0.05 level.|ANCOVA|||Change at Week 12: ANCOVA model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.||-0.04|-0.33|0.0112
72508474|NCT03691623|144547984|SUPERIORITY||LS Mean Difference|-3.2191|||<|0.001|TWO_SIDED|95.0|-4.1915|-2.2467|||ANCOVA|||||-2.2467|-4.1915|< 0.001
72508475|NCT03691623|144547984|SUPERIORITY||LS Mean Difference|-2.7831|||<|0.001|TWO_SIDED|95.0|-3.8522|-1.714|||ANCOVA|||||-1.714|-3.8522|< 0.001
72508476|NCT03691623|144547985|SUPERIORITY||LS Mean Difference|-2.01|||<|0.001|TWO_SIDED|95.0|-2.67|-1.35|||ANCOVA|||||-1.35|-2.67|< 0.001
72508477|NCT03691623|144547985|SUPERIORITY||LS Mean Difference|-1.78|||<|0.001|TWO_SIDED|95.0|-2.4|-1.16|||ANCOVA|||||-1.16|-2.4|< 0.001
72508478|NCT03691623|144547985|SUPERIORITY||LS Mean Difference|-1.98|||=|0.009|TWO_SIDED|95.0|-3.43|-0.54|||ANCOVA|||||-0.54|-3.43|= 0.009
72508479|NCT03691623|144547985|SUPERIORITY||LS Mean Difference|-2.41|||=|0.004|TWO_SIDED|95.0|-4.0|-0.82|||ANCOVA|||||-0.82|-4|= 0.004
72508480|NCT03691623|144547986|SUPERIORITY||LS Mean Difference|-2.1|||<|0.001|TWO_SIDED|95.0|-3.04|-1.17|||ANCOVA|||||-1.17|-3.04|< 0.001
72508481|NCT03691623|144547986|SUPERIORITY||LS Mean Difference|-2.0|||<|0.001|TWO_SIDED|95.0|-2.89|-1.11|||ANCOVA|||||-1.11|-2.89|< 0.001
72508482|NCT03691623|144547986|SUPERIORITY||LS Mean Difference|-1.97|||<|0.001|TWO_SIDED|95.0|-3.06|-0.89|||ANCOVA|||||-0.89|-3.06|< 0.001
72508483|NCT03691623|144547986|SUPERIORITY||LS Mean Difference|-2.46|||<|0.001|TWO_SIDED|95.0|-3.64|-1.29|||ANCOVA|||||-1.29|-3.64|< 0.001
72508484|NCT03691623|144547987|SUPERIORITY||||||<|0.001|||||||Log Rank|||||||< 0.001
72508485|NCT03691623|144547987|SUPERIORITY||||||<|0.001|||||||Log Rank|||||||< 0.001
72508486|NCT03691623|144547987|SUPERIORITY||||||=|0.001|||||||Log Rank|||||||= 0.001
72508487|NCT03691623|144547987|SUPERIORITY||||||<|0.001|||||||Log Rank|||||||< 0.001
72508488|NCT01070550|144548030|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.903||||0.0126|TWO_SIDED|95.0|0.833|0.978|||Regression, Logistic|||The statistical analysis is presented for age per 10 years. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.978|0.833|0.0126
72399409|NCT00455429|144305819|SUPERIORITY_OR_OTHER|||||||0.107|||||||Regression, Logistic|||||||0.107
72399410|NCT00455429|144305820|SUPERIORITY_OR_OTHER|||||||0.097|||||||Regression, Logistic|||||||0.097
72399411|NCT00455429|144305820|SUPERIORITY_OR_OTHER|||||||0.077|||||||Regression, Logistic|||||||0.077
72399412|NCT00455429|144305820|SUPERIORITY_OR_OTHER|||||||0.489|||||||Regression, Logistic|||||||0.489
72399413|NCT00455429|144305821|SUPERIORITY_OR_OTHER|||||||0.566|||||||Regression, Logistic|||||||0.566
72399414|NCT00455429|144305821|SUPERIORITY_OR_OTHER|||||||0.382|||||||Regression, Logistic|||||||0.382
72476648|NCT00911937|144478913|SUPERIORITY_OR_OTHER|||||||0.0023|TWO_SIDED|||||Statistical testing, two-sided, was done at alpha = 0.05 level.|Ranked ANCOVA|Testing for percent change from baseline was only carried out for given endpoint if corresponding numeric change result was statistically significant.||Change at Week 12: Ranked ANCOVA model with terms for treatment and center with ranked baseline value as a covariate was used to calculate p-value.||||0.0023
72476649|NCT00911937|144478915|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.45|STANDARD_ERROR_OF_MEAN|0.15||0.0026|TWO_SIDED|95.0|-0.74|-0.16||Statistical testing, two-sided, was done at alpha = 0.05 level.|ANCOVA|||Change at Week 4: ANCOVA model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.||-0.16|-0.74|0.0026
72476650|NCT00911937|144478915|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.56|STANDARD_ERROR_OF_MEAN|0.17||0.0014|TWO_SIDED|95.0|-0.9|-0.22||Statistical testing, two-sided, was done at alpha = 0.05 level.|ANCOVA|||Change at Week 12: ANCOVA model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.||-0.22|-0.90|0.0014
72476651|NCT00911937|144478916|SUPERIORITY_OR_OTHER|||||||0.0016|TWO_SIDED|||||Statistical testing, two-sided, was done at alpha = 0.05 level.|Ranked ANCOVA|Testing for percent change from baseline was only carried out for given endpoint if corresponding numeric change result was statistically significant.||Change at Week 4: Ranked ANCOVA model with terms for treatment and center with ranked baseline value as a covariate was used to calculate p-value.||||0.0016
72476652|NCT00911937|144478916|SUPERIORITY_OR_OTHER|||||||0.0004|TWO_SIDED|||||Statistical testing, two-sided, was done at alpha = 0.05 level.|Ranked ANCOVA|Testing for percent change from baseline was only carried out for given endpoint if corresponding numeric change result was statistically significant.||Change at Week 12: Ranked ANCOVA model with terms for treatment and center with ranked baseline value as a covariate was used to calculate p-value.||||0.0004
72476653|NCT00911937|144478918|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.59|STANDARD_ERROR_OF_MEAN|0.22||0.0072|TWO_SIDED|95.0|-1.03|-0.16||Statistical testing, two-sided, was done at alpha = 0.05 level.|ANCOVA|||Change at Week 4: ANCOVA model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.||-0.16|-1.03|0.0072
72623276|NCT03766399|144777260|OTHER||LS means difference|-98.7||||0.2377|TWO_SIDED|90.0|-240.0|42.3|||Linear Mixed Model|||Comparison of Part 2a (MAD) Cohort 1 Vs Part 2a (MAD) Placebo||42.3|-240|0.2377
72399415|NCT00455429|144305821|SUPERIORITY_OR_OTHER|||||||0.282|||||||Regression, Logistic|||||||0.282
72399416|NCT00455429|144305822|SUPERIORITY_OR_OTHER|||||||0.206|||||||Regression, Logistic|||||||0.206
72399417|NCT00455429|144305822|SUPERIORITY_OR_OTHER|||||||0.433|||||||Regression, Logistic|||||||0.433
72399418|NCT00455429|144305822|SUPERIORITY_OR_OTHER|||||||0.29|||||||Regression, Logistic|||||||0.290
72399419|NCT00455429|144305823|SUPERIORITY_OR_OTHER|||||||0.484|||||||Regression, Logistic|||||||0.484
72399420|NCT00455429|144305823|SUPERIORITY_OR_OTHER|||||||0.952|||||||Regression, Logistic|||||||0.952
72399421|NCT00455429|144305823|SUPERIORITY_OR_OTHER|||||||0.35|||||||Regression, Logistic|||||||0.350
72399422|NCT04351087|144305849|EQUIVALENCE|Power analysis based on (MCID) for the KOOS-Pain, alpha 0.05 \& SD 15 points, 88 patients (44/group) would be required to detect a 9-point difference between treatment groups with 80% power. Due to change in regulatory requirements during accrual, enrollment was halted at 79 patients with 71 meeting inclusion criteria. A repeated power calculation demonstrated that the study achieved 56% power to detect a between-group difference in excess of the 9-point MCID for the KOOS-Pain.|Mean Difference (Final Values)|2.17||||0.69|TWO_SIDED|95.0|-8.57|12.92|||t-test, 2 sided|||||12.92|-8.57|0.69
72399423|NCT05517382|144305872|SUPERIORITY|||||||0.2|||||||t-test, 2 sided|||At baseline||||0.20
72476654|NCT00911937|144478918|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.79|STANDARD_ERROR_OF_MEAN|0.24||0.0009|TWO_SIDED|95.0|-1.25|-0.32||Statistical testing, two-sided, was done at alpha = 0.05 level.|ANCOVA|||Change at Week 12: ANCOVA model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.||-0.32|-1.25|0.0009
72623277|NCT03766399|144777260|OTHER||LS means difference|-50.4||||0.1105|TWO_SIDED|90.0|-102.0|1.61|||Linear Mixed Model|||Comparison of Part 3a (DPI/PoM) Vs Part 3a (DPI/PoM) Placebo||1.61|-102|0.1105
72399424|NCT05517382|144305872|SUPERIORITY|||||||0.59|||||||t-test, 2 sided|||At Post game||||0.59
72399425|NCT05517382|144305872|SUPERIORITY|||||||0.94|||||||t-test, 2 sided|||At 3 month||||0.94
72399426|NCT05517382|144305872|SUPERIORITY|||||||0.55|||||||GEE|Controlling for baseline thriving status, this reflects the interaction between the intervention group and time.||||||0.55
72399427|NCT05517382|144305873|SUPERIORITY||Mean Difference (Net)|-0.09||||0.1759|TWO_SIDED|95.0|-0.23|0.04|||Mixed Models Analysis||Group effect.|At post game.||0.04|-0.23|0.1759
72399428|NCT05517382|144305873|SUPERIORITY||Mean Difference (Net)|-0.16||||0.0857|TWO_SIDED|95.0|-0.35|0.02|||Mixed Models Analysis||Group effect.|At 3 month||0.02|-0.35|0.0857
72399429|NCT01641692|144305883|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.066||||0.036|TWO_SIDED|95.0|0.004|0.127|||Mixed Models Analysis|||||0.127|0.004|0.036
72399430|NCT01641692|144305883|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.03||||0.331|TWO_SIDED|95.0|-0.03|0.09|||Mixed Models Analysis|||||0.090|-0.030|0.331
72399431|NCT01641692|144305883|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.034||||0.272|TWO_SIDED|95.0|-0.027|0.095|||Mixed Models Analysis|||||0.095|-0.027|0.272
72399432|NCT01641692|144305883|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.088||||0.005|TWO_SIDED|95.0|0.026|0.149|||Mixed Models Analysis|||||0.149|0.026|0.005
72399433|NCT01641692|144305883|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.011||||0.722|TWO_SIDED|95.0|-0.05|0.073|||Mixed Models Analysis|||||0.073|-0.050|0.722
72399434|NCT01641692|144305883|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.057||||0.076|TWO_SIDED|95.0|-0.006|0.119|||Mixed Models Analysis|||||0.119|-0.006|0.076
72399435|NCT01641692|144305883|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.051||||0.101|TWO_SIDED|95.0|-0.01|0.113|||Mixed Models Analysis|||||0.113|-0.010|0.101
72399436|NCT01641692|144305886|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2||||0.84|TWO_SIDED|95.0|-2.1|1.7|||Mixed Models Analysis|||||1.7|-2.1|0.840
72399437|NCT01641692|144305886|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6||||0.553|TWO_SIDED|95.0|-2.4|1.3|||Mixed Models Analysis|||||1.3|-2.4|0.553
72476655|NCT00911937|144478919|SUPERIORITY_OR_OTHER|||||||0.0041|TWO_SIDED|||||Statistical testing, two-sided, was done at alpha = 0.05 level.|Ranked ANCOVA|Testing for percent change from baseline was only carried out for given endpoint if corresponding numeric change result was statistically significant.||Change at Week 4: Ranked ANCOVA model with terms for treatment and center with ranked baseline value as a covariate was used to calculate p-value.||||0.0041
72476656|NCT00911937|144478919|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Statistical testing, two-sided, was done at alpha = 0.05 level.|Ranked ANCOVA|Testing for percent change from baseline was only carried out for given endpoint if corresponding numeric change result was statistically significant.||Change at Week 4: Ranked ANCOVA model with terms for treatment and center with ranked baseline value as a covariate was used to calculate p-value.||||<0.0001
72476657|NCT00911937|144478921|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.14|STANDARD_ERROR_OF_MEAN|0.17||0.3954|TWO_SIDED|95.0|-0.47|0.19||Statistical testing, two-sided, was done at alpha = 0.05 level.|ANCOVA|||Change at Week 4: ANCOVA model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.||0.19|-0.47|0.3954
72508489|NCT01070550|144548030|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.966||||0.0042|TWO_SIDED|95.0|0.944|0.989|||Regression, Logistic|||The statistical analysis is presented for Body Mass Index (BMI) in kilogram per square meter (kg/m\^2). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.989|0.944|0.0042
72508490|NCT01070550|144548030|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.732|||<|0.0001|TWO_SIDED|95.0|0.656|0.816|||Regression, Logistic|||The statistical analysis is presented for HCV RNA at Baseline (BL) in log10(IU/mL). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.816|0.656|<0.0001
72566320|NCT02697773|144663264|SUPERIORITY||Odds Ratio (OR)|1.27||||0.2283|TWO_SIDED|95.0|0.86|1.87|||Regression, Logistic|||Week 8: Odds ratio and 95% confidence interval (CI) estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||1.87|0.86|0.2283
72566321|NCT02697773|144663264|SUPERIORITY||Odds Ratio (OR)|1.38||||0.1066|TWO_SIDED|95.0|0.93|2.03|||Regression, Logistic|||Week 8: Odds ratio and 95% confidence interval (CI) estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.03|0.93|0.1066
72566322|NCT02697773|144663264|SUPERIORITY||Odds Ratio (OR)|1.68||||0.0154|TWO_SIDED|95.0|1.1|2.54|||Regression, Logistic|||Week 12: Odds ratio and 95% confidence interval (CI) estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.54|1.10|0.0154
72566323|NCT02697773|144663264|SUPERIORITY||Odds Ratio (OR)|2.13||||0.0006|TWO_SIDED|95.0|1.38|3.27|||Regression, Logistic|||Week 12: Odds ratio and 95% confidence interval (CI) estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.27|1.38|0.0006
72566324|NCT02697773|144663264|SUPERIORITY||Odds Ratio (OR)|1.39||||0.1139|TWO_SIDED|95.0|0.92|2.07|||Regression, Logistic|||Week 16: Odds ratio and 95% confidence interval (CI) estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.07|0.92|0.1139
72399438|NCT01641692|144305886|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.5||||0.121|TWO_SIDED|95.0|-0.4|3.3|||Mixed Models Analysis|||||3.3|-0.4|0.121
72508491|NCT01070550|144548030|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.686|||<|0.0001|TWO_SIDED|95.0|1.347|2.109|||Regression, Logistic|||The statistical analysis is presented for liver fibrosis (no cirrhosis vs cirrhosis). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||2.109|1.347|<0.0001
72623278|NCT02014376|144777261|SUPERIORITY||||||=|0.3699|||||||Fisher Exact|||||||=0.3699
72399439|NCT01641692|144305886|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2||||0.814|TWO_SIDED|95.0|-2.1|1.7|||Mixed Models Analysis|||||1.7|-2.1|0.814
72399440|NCT01641692|144305886|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.4||||0.683|TWO_SIDED|95.0|-1.5|2.3|||Mixed Models Analysis|||||2.3|-1.5|0.683
72399441|NCT01641692|144305886|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.7||||0.456|TWO_SIDED|95.0|-1.2|2.7|||Mixed Models Analysis|||||2.7|-1.2|0.456
72399442|NCT01641692|144305886|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8||||0.399|TWO_SIDED|95.0|-2.7|1.1|||Mixed Models Analysis|||||1.1|-2.7|0.399
72399443|NCT01641692|144305887|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.7||||0.03|TWO_SIDED|95.0|0.2|3.2|||Mixed Models Analysis|||||3.2|0.2|0.030
72399444|NCT01641692|144305887|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.3||||0.077|TWO_SIDED|95.0|-0.1|2.8|||Mixed Models Analysis|||||2.8|-0.1|0.077
72399445|NCT01641692|144305887|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.0||||0.01|TWO_SIDED|95.0|0.5|3.5|||Mixed Models Analysis|||||3.5|0.5|0.010
72399446|NCT01641692|144305887|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.4||||0.002|TWO_SIDED|95.0|0.9|3.9|||Mixed Models Analysis|||||3.9|0.9|0.002
72476658|NCT00911937|144478921|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.19|STANDARD_ERROR_OF_MEAN|0.15||0.2166|TWO_SIDED|95.0|-0.48|0.11||Statistical testing, two-sided, was done at alpha = 0.05 level.|ANCOVA|||Change at Week 12: ANCOVA model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.||0.11|-0.48|0.2166
72476659|NCT00911937|144478924|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.39|STANDARD_ERROR_OF_MEAN|0.24||0.1018|TWO_SIDED|95.0|-0.85|0.08||Statistical testing, two-sided, was done at alpha = 0.05 level.|ANCOVA|||Change at Week 4: ANCOVA model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.||0.08|-0.85|0.1018
72476660|NCT00911937|144478924|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.73|STANDARD_ERROR_OF_MEAN|0.24||0.0027|TWO_SIDED|95.0|-1.2|-0.25||Statistical testing, two-sided, was done at alpha = 0.05 level.|ANCOVA|||Change at Week 12: ANCOVA model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.||-0.25|-1.20|0.0027
72476661|NCT00911937|144478926|SUPERIORITY_OR_OTHER||Least squares mean difference|-1.56|STANDARD_ERROR_OF_MEAN|0.63||0.0131|TWO_SIDED|95.0|-2.79|-0.33||Statistical testing, two-sided, was done at alpha = 0.05 level.|ANCOVA|||Change at Week 4: ANCOVA model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.||-0.33|-2.79|0.0131
72476662|NCT00911937|144478926|SUPERIORITY_OR_OTHER||Least squares mean difference|-2.43|STANDARD_ERROR_OF_MEAN|0.69||0.0004|TWO_SIDED|95.0|-3.78|-1.08||Statistical testing, two-sided, was done at alpha = 0.05 level.|ANCOVA|||Change at Week 12: ANCOVA model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.||-1.08|-3.78|0.0004
72476663|NCT00911937|144478928|SUPERIORITY_OR_OTHER||Least squares mean difference|1.32|STANDARD_ERROR_OF_MEAN|7.2||0.8547|TWO_SIDED|95.0|-12.82|15.46||Statistical testing, two-sided, was done at alpha = 0.05 level.|ANCOVA|||ANCOVA model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.||15.46|-12.82|0.8547
72476664|NCT00911937|144478930|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.85|STANDARD_ERROR_OF_MEAN|4.22||0.8396|TWO_SIDED|95.0|-9.14|7.44||Statistical testing, two-sided, was done at alpha = 0.05 level.|ANCOVA|||ANCOVA model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.||7.44|-9.14|0.8396
72476665|NCT00911937|144478932|SUPERIORITY_OR_OTHER||Least squares mean difference|-4.37|STANDARD_ERROR_OF_MEAN|1.26||0.0006|TWO_SIDED|95.0|-6.84|-1.89||Statistical testing, two-sided, was done at alpha = 0.05 level.|ANCOVA|||Change at Week 12: ANCOVA model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.||-1.89|-6.84|0.0006
72476666|NCT00911937|144478934|SUPERIORITY_OR_OTHER||Least squares mean difference|3.42|STANDARD_ERROR_OF_MEAN|1.34||0.011|TWO_SIDED|95.0|0.79|6.05||Statistical testing, two-sided, was done at alpha = 0.05 level.|ANCOVA|||Change at Week 12: Concern domain- ANCOVA model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.||6.05|0.79|0.0110
72476667|NCT00911937|144478934|SUPERIORITY_OR_OTHER||Least squares mean difference|3.14|STANDARD_ERROR_OF_MEAN|1.35||0.02|TWO_SIDED|95.0|0.5|5.79||Statistical testing, two-sided, was done at alpha = 0.05 level.|ANCOVA|||Change at Week 12: Coping domain- ANCOVA model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.||5.79|0.50|0.0200
72476668|NCT00911937|144478934|SUPERIORITY_OR_OTHER||Least squares mean difference|3.48|STANDARD_ERROR_OF_MEAN|1.51||0.0218|TWO_SIDED|95.0|0.51|6.45||Statistical testing, two-sided, was done at alpha = 0.05 level.|ANCOVA|||Change at Week 12: Sleep domain- ANCOVA model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.||6.45|0.51|0.0218
72476669|NCT00911937|144478934|SUPERIORITY_OR_OTHER||Least squares mean difference|1.86|STANDARD_ERROR_OF_MEAN|0.93||0.0458|TWO_SIDED|95.0|0.03|3.68||Statistical testing, two-sided, was done at alpha = 0.05 level.|ANCOVA|||Change at Week 12: Social interaction domain- ANCOVA model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.||3.68|0.03|0.0458
72476670|NCT00911937|144478934|SUPERIORITY_OR_OTHER||Least squares mean difference|3.02|STANDARD_ERROR_OF_MEAN|1.17||0.01|TWO_SIDED|95.0|0.72|5.32||Statistical testing, two-sided, was done at alpha = 0.05 level.|ANCOVA|||Change at Week 12: Total- ANCOVA model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.||5.32|0.72|0.0100
72476671|NCT03484273|144478982|SUPERIORITY||||||<|0.001|||||||ANOVA|Repeated Measures ANOVA||Repeated Measured ANOVA was used to compare the 4 compression garment configurations.||||<0.001
72476672|NCT03484273|144478983|SUPERIORITY||||||<|0.001|||||||Repeated Measures ANOVA|||||||<0.001
72476673|NCT03484273|144478984|SUPERIORITY||||||<|0.001|||||||Repeated Measures ANOVA|||||||<0.001
72476674|NCT03484273|144478985|SUPERIORITY|||||||0.01|||||||Repeated Measures ANOVA|||||||0.01
72476675|NCT03484273|144478986|SUPERIORITY||||||<|0.001|||||||Repeated Measures ANOVA|||||||<0.001
72476676|NCT03484273|144478987|SUPERIORITY|||||||0.001|||||||Repeated Measures ANOVA|||||||0.001
72476677|NCT03484273|144478988|SUPERIORITY|||||||0.04|||||||Repeated Measures ANOVA|||||||0.04
72476678|NCT00294515|144479001|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.4|||<=|0.0002|TWO_SIDED|95.0|0.25|0.66|||Cochran-Mantel-Haenszel|Stratified by Center Pools||||0.66|0.25|<=0.0002
72476679|NCT00294515|144479002|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.2|||<|0.0001||95.0|0.11|0.37|||Cochran-Mantel-Haenszel|Stratified by Center Pools||||0.37|0.11|<0.0001
72476680|NCT00294515|144479003|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.37||||0.0001||95.0|0.22|0.6|||Cochran-Mantel-Haenszel|Stratified by Center Pools||||0.60|0.22|0.0001
72476681|NCT00294515|144479004|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.56||||0.0126||95.0|0.35|0.88|||Cochran-Mantel-Haenszel|Stratified by Center Pools||||0.88|0.35|0.0126
72476682|NCT00294515|144479005|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.55||||0.01||95.0|0.34|0.86|||Cochran-Mantel-Haenszel|Stratified by Center Pools||||0.86|0.34|0.0100
72508492|NCT01070550|144548030|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.103||||0.4759|TWO_SIDED|95.0|0.843|1.442|||Regression, Logistic|||The statistical analysis is presented for liver fibrosis (not assessed/missed vs cirrhosis). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.442|0.843|0.4759
72508493|NCT01070550|144548030|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.656||||0.018|TWO_SIDED|95.0|0.462|0.93|||Regression, Logistic|||The statistical analysis is presented for Alanine transaminase (ALT) ratio at BL (\<=1 vs \> 3). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.930|0.462|0.0180
72508494|NCT01070550|144548030|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.742||||0.0262|TWO_SIDED|95.0|0.57|0.965|||Regression, Logistic|||The statistical analysis is presented for ALT ratio at BL (\> 1 - 3 vs \> 3). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.965|0.570|0.0262
72508495|NCT01070550|144548030|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.717||||0.0069|TWO_SIDED|95.0|0.563|0.913|||Regression, Logistic|||The statistical analysis is presented for aspartate aminotransferase (AST) ratio at BL (\> 1.5 vs \<=1.5). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.913|0.563|0.0069
72508496|NCT01070550|144548030|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.062|||<|0.0001|TWO_SIDED|95.0|1.056|1.067|||Regression, Logistic|||The statistical analysis is presented for treatment duration after VR in weeks. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.067|1.056|<0.0001
72508497|NCT01070550|144548030|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.107||||0.0062|TWO_SIDED|95.0|1.029|1.191|||Regression, Logistic|||The statistical analysis is presented for cumulative ribavirin dose per 10000 mg, first 12 weeks. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.191|1.029|0.0062
72476683|NCT00371683|144479100|NON_INFERIORITY_OR_EQUIVALENCE|Two criteria were to be met to demonstrate non-inferiority: the upper bound of the 95% confidence interval (CI) for the Relative Risk should be \< 1.25, and the upper bound of the 95% CI for the risk difference should be \< 5.6%.|Risk Ratio (RR)|1.02||||0.0635|TWO_SIDED|95.0|0.78|1.32||If p-value is less than 0.025, it is statistically significant.|t-test, 1 sided|||||1.32|0.78|0.0635
72476684|NCT00371683|144479100|NON_INFERIORITY_OR_EQUIVALENCE|Two criteria were to be met to demonstrate non-inferiority: the upper bound of the 95% CI for the relative risk should be \< 1.25, and the upper bound of the 95% CI for the risk difference should be \< 5.6%.|Risk Difference (RD)|0.11|||<|0.0001|TWO_SIDED|95.0|-2.22|2.44||If p-value is less than 0.025, it is statistically significant.|t-test, 1 sided|||||2.44|-2.22|<0.0001
72476685|NCT00371683|144479101|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.25|||||TWO_SIDED|95.0|0.7|2.23|||||If the upper bound of the two-sided 95% CI for the Relative Risk was \< 1 then superiority for the key secondary efficacy endpoint was demonstrated.|||2.23|0.70|
72476686|NCT00371683|144479101|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.36|||||TWO_SIDED|95.0|-0.68|1.4||||||||1.40|-0.68|
72476687|NCT00371683|144479101|SUPERIORITY_OR_OTHER|||||||0.7779|TWO_SIDED||||||t-test, 1 sided|||||||0.7779
72476688|NCT00371683|144479102|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.04|||||TWO_SIDED|95.0|0.8|1.35||||||||1.35|0.80|
72476689|NCT00371683|144479102|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.28|||||TWO_SIDED|95.0|-2.04|2.59||||||||2.59|-2.04|
72476690|NCT00371683|144479102|SUPERIORITY_OR_OTHER|||||||0.7754|TWO_SIDED|||||For descriptive purposes only, p-values were presented for the test of equality of event rates|test of equality|||||||0.7754
72476691|NCT00371683|144479103|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.41|||||TWO_SIDED|95.0|0.77|2.6||||||||2.60|0.77|
72476692|NCT00371683|144479103|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.53|||||TWO_SIDED|95.0|-0.47|1.52||||||||1.52|-0.47|
72476693|NCT00371683|144479103|SUPERIORITY_OR_OTHER|||||||0.2626|TWO_SIDED|||||For descriptive purposes only, p-values were presented for the test of equality of event rates|test of equality|||||||0.2626
72476694|NCT00371683|144479104|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.08|||||TWO_SIDED|95.0|0.63|1.87||||||||1.87|0.63|
72476695|NCT00371683|144479104|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.11|||||TWO_SIDED|95.0|-0.99|1.21||||||||1.21|-0.99|
72476696|NCT00371683|144479104|SUPERIORITY_OR_OTHER|||||||0.77|TWO_SIDED|||||For descriptive purposes only, p-values were presented for the test of equality of event rates|test of equality|||||||0.7700
72476697|NCT00371683|144479105|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.19|||||TWO_SIDED|95.0|0.68|2.11||||||||2.11|0.68|
72476698|NCT00371683|144479105|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.28|||||TWO_SIDED|95.0|-0.78|1.33||||||||1.33|-0.78|
72476699|NCT00371683|144479105|SUPERIORITY_OR_OTHER|||||||0.5443|TWO_SIDED||||||test of equality|For descriptive purposes only, p-values were presented for the test of equality of event rates||||||0.5443
72476700|NCT00371683|144479106|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.0|||||TWO_SIDED|95.0|0.2|4.93||||||||4.93|0.20|
72476701|NCT00371683|144479106|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.0|||||TWO_SIDED|95.0|-0.3|0.3||||||||0.30|-0.30|
72476702|NCT00371683|144479106|SUPERIORITY_OR_OTHER|||||||0.9975|TWO_SIDED|||||For descriptive purposes only, p-values were presented for the test of equality of event rates|test of equality|||||||0.9975
72476703|NCT00371683|144479107|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.13|||||TWO_SIDED|95.0|-0.05|0.3||||||||0.30|-0.05|
72476704|NCT00371683|144479107|SUPERIORITY_OR_OTHER|||||||0.1578|TWO_SIDED|||||For descriptive purposes only, p-values were presented for the test of equality of event rates|test of equality|||||||0.1578
72476705|NCT00371683|144479108|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.25|||||TWO_SIDED|95.0|0.65|2.4||||||||2.40|0.65|
72476706|NCT00371683|144479108|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.25|||||TWO_SIDED|95.0|-0.47|0.98||||||||0.98|-0.47|
72476707|NCT00371683|144479109|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.46|||||TWO_SIDED|95.0|0.72|2.95||||||||2.95|0.72|
72399447|NCT01641692|144305887|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.2||||0.005|TWO_SIDED|95.0|0.7|3.7|||Mixed Models Analysis|||||3.7|0.7|0.005
72476708|NCT00371683|144479109|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.38|||||TWO_SIDED|95.0|-0.3|1.06||||||||1.06|-0.30|
72476709|NCT00371683|144479109|SUPERIORITY_OR_OTHER|||||||0.2873|TWO_SIDED|||||For descriptive purposes only, p-values were presented for the test of equality of event rates|test of equality|||||||0.2873
72476710|NCT00371683|144479110|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.94|||||TWO_SIDED|95.0|0.74|1.2||||||||1.20|0.74|
72476711|NCT00371683|144479110|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.83|||||TWO_SIDED|95.0|-3.3|1.63||||||||1.63|-3.30|
72476712|NCT00371683|144479110|SUPERIORITY_OR_OTHER|||||||0.6145|TWO_SIDED|||||For descriptive purposes only, p-values were presented for the test of equality of event rates|test of equality|||||||0.6145
72476713|NCT00371683|144479113|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.25|||||TWO_SIDED|95.0|-0.55|0.05||||||Adjusted difference of event rates of MI/Stroke. Type of surgery was taken into consideration as a stratification factor.||0.05|-0.55|
72476714|NCT00371683|144479113|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.19|||||TWO_SIDED|95.0|-0.46|0.09||||||Adjusted difference of event rates of MI. Type of surgery was taken into consideration as a stratification factor.||0.09|-0.46|
72476715|NCT00371683|144479113|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.13|||||TWO_SIDED|95.0|-0.3|0.05||||||Adjusted difference of event rates of Stroke. Type of surgery was taken into consideration as a stratification factor.||0.05|-0.30|
72476716|NCT00371683|144479113|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.13|||||TWO_SIDED|95.0|-0.3|0.05||||||Adjusted difference of event rates of thrombocytopenia. Type of surgery was taken into consideration as a stratification factor.||0.05|-0.30|
72476717|NCT00371683|144479114|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.81|||||TWO_SIDED|95.0|-1.49|-0.14||||||Adjusted difference of event rates of Major Bleeding. Type of surgery was taken into consideration as a stratification factor.||-0.14|-1.49|
72476718|NCT00371683|144479114|SUPERIORITY_OR_OTHER|||||||0.0533|TWO_SIDED|||||For descriptive purposes only, p-values were presented for the test of equality of event rates|test of equality|||Major Bleeding Endpoint||||0.0533
72476719|NCT00371683|144479114|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.77|||||TWO_SIDED|95.0|-1.87|0.33||||||Adjusted difference of event rates of Clinically Relevant Non-Major Bleeding. Type of surgery was taken into consideration as a stratification factor.||0.33|-1.87|
72476720|NCT00371683|144479114|SUPERIORITY_OR_OTHER|||||||0.1709|TWO_SIDED|||||For descriptive purposes only, p-values were presented for the test of equality of event rates|test of equality|||Clinically relevant Non-Major Bleeding endpoint||||0.1709
72476721|NCT00371683|144479114|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-1.46|||||TWO_SIDED|95.0|-2.75|-0.17||||||Adjusted difference of event rates of Major or Clinically Relevant Non-Major Bleeding. Type of surgery was taken into consideration as a stratification factor.||-0.17|-2.75|
72476722|NCT00371683|144479114|SUPERIORITY_OR_OTHER|||||||0.0338|TWO_SIDED||||||test of equality|For descriptive purposes only, p-values were presented for the test of equality of event rates||Major or Clinically Relevant Non-Major Bleeding endpoint.||||0.0338
72476723|NCT00371683|144479114|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-1.52|||||TWO_SIDED|95.0|-3.18|0.13||||||Adjusted difference of event rates of Any Bleeding. Type of surgery was taken into consideration as a stratification factor.||0.13|-3.18|
72476724|NCT00371683|144479114|SUPERIORITY_OR_OTHER|||||||0.0816|TWO_SIDED|||||For descriptive purposes only, p-values were presented for the test of equality of event rates|test of equality|||Any Bleeding Endpoint.||||0.0816
72476725|NCT01151410|144479149|NON_INFERIORITY_OR_EQUIVALENCE|Indicates statistical significance at 0.025 level for one sided non-inferiority testing at 4mmHg margin.|Mean Difference (Net)|0.31||||0.004|ONE_SIDED|95.0|-2.4||||ANCOVA||||||-2.40|0.0040
72476726|NCT01237587|144479259|SUPERIORITY||LS mean change difference|-0.65|STANDARD_ERROR_OF_MEAN|0.33||0.052|TWO_SIDED|95.0|-1.3|0.0|||Repeated Measures|||||0.00|-1.30|0.052
72566325|NCT02697773|144663264|SUPERIORITY||Odds Ratio (OR)|1.99||||0.0014|TWO_SIDED|95.0|1.31|3.04|||Regression, Logistic|||Week 16: Odds ratio and 95% confidence interval (CI) estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.04|1.31|0.0014
72399448|NCT01641692|144305887|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.7|||<|0.001|TWO_SIDED|95.0|1.2|4.3|||Mixed Models Analysis|||||4.3|1.2|<0.001
72399449|NCT01641692|144305887|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.5||||0.054|TWO_SIDED|95.0|0.0|3.0|||Mixed Models Analysis|||||3.0|0.0|0.054
72476727|NCT01237587|144479260|SUPERIORITY||Mean Difference (Final Values)|-0.68|STANDARD_ERROR_OF_MEAN|0.36||0.059|TWO_SIDED|95.0|-1.4|0.03|||Mixed Models Analysis|||Worst Pain||0.03|-1.40|.059
72476728|NCT01237587|144479260|SUPERIORITY||Mean Difference (Final Values)|-0.61|STANDARD_ERROR_OF_MEAN|0.319||0.059|TWO_SIDED|95.0|-1.24|0.02|||Mixed Models Analysis|||Least Pain||0.02|-1.24|0.059
72476729|NCT01237587|144479260|SUPERIORITY||Mean Difference (Final Values)|-0.51|STANDARD_ERROR_OF_MEAN|0.365||0.165|TWO_SIDED|95.0|-1.23|0.21|||Mixed Models Analysis|||Pain Right Now||0.21|-1.23|.165
72476730|NCT01237587|144479260|SUPERIORITY||Mean Difference (Final Values)|-0.97|STANDARD_ERROR_OF_MEAN|0.344||0.005|TWO_SIDED|95.0|-1.65|-0.3|||Mixed Models Analysis|||General Activity||-0.30|-1.65|0.005
72476731|NCT01237587|144479260|SUPERIORITY||Mean Difference (Final Values)|-0.54|STANDARD_ERROR_OF_MEAN|0.356||0.128|TWO_SIDED|95.0|-1.25|0.16|||Mixed Models Analysis|||Mood||0.16|-1.25|.128
72476732|NCT01237587|144479260|SUPERIORITY||Mean Difference (Final Values)|-0.21|STANDARD_ERROR_OF_MEAN|0.352||0.56|TWO_SIDED|95.0|-0.9|0.49|||Mixed Models Analysis|||Walking ability||0.49|-0.90|.560
72476733|NCT01237587|144479260|SUPERIORITY||Mean Difference (Final Values)|-0.28|STANDARD_ERROR_OF_MEAN|0.371||0.448|TWO_SIDED|95.0|-1.01|0.45|||Mixed Models Analysis|||Normal Work||0.45|-1.01|0.448
72476734|NCT01237587|144479260|SUPERIORITY||Mean Difference (Final Values)|-0.8|STANDARD_ERROR_OF_MEAN|0.312||0.011|TWO_SIDED|95.0|-1.42|-0.19|||Mixed Models Analysis|||Relations With Other||-0.19|-1.42|.011
72476735|NCT01237587|144479260|SUPERIORITY||Mean Difference (Final Values)|-0.35|STANDARD_ERROR_OF_MEAN|0.454||0.443|TWO_SIDED|95.0|-1.25|0.55|||Mixed Models Analysis|||Sleep||0.55|-1.25|.443
72476736|NCT01237587|144479260|SUPERIORITY||Mean Difference (Final Values)|-0.29|STANDARD_ERROR_OF_MEAN|0.338||0.39|TWO_SIDED|95.0|-0.96|0.38|||Mixed Models Analysis|||Enjoyment of Life||0.38|-0.96|.390
72623279|NCT04875533|144777288|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the ratio of GMT20vPnC/saline to GMT13vPnC/PPSV23 for that serotype is greater than 0.5 (2-fold criterion).|Ratio of GMTs (20vPnC/13vPnC)|0.78|||||TWO_SIDED|95.0|0.66|0.92||||||Serotype 1: the ratio of GMT (GMR) (the 20vPnC/saline group to the 13vPnC/PPSV23 group) and the 2-sided 95% CI||0.92|0.66|
72476737|NCT01237587|144479260|SUPERIORITY||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.424||0.16|TWO_SIDED|95.0|-1.44|0.24|||Mixed Models Analysis|||School Work||0.24|-1.44|.160
72476738|NCT01237587|144479262|SUPERIORITY|||||||0.051|||||||Fisher Exact|||||||.051
72476739|NCT01237587|144479263|SUPERIORITY|||||||0.038|||||||Fisher Exact|||||||.038
72476740|NCT01237587|144479264|SUPERIORITY||Mean Difference (Final Values)|1.62||||0.669|TWO_SIDED|95.0|-9.1|5.86|||ANCOVA|||Average Pain Score||5.86|-9.10|.669
72476741|NCT01237587|144479264|SUPERIORITY||Mean Difference (Final Values)|-5.9||||0.169|TWO_SIDED|95.0|-14.32|2.53|||ANCOVA|||Worst Pain Score||2.53|-14.32|.169
72476742|NCT01237587|144479264|SUPERIORITY||Mean Difference (Final Values)|-1.79||||0.647|TWO_SIDED|95.0|-9.53|5.94|||ANCOVA|||Pain Score Right Now||5.94|-9.53|.647
72623280|NCT04875533|144777288|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the ratio of GMT20vPnC/saline to GMT13vPnC/PPSV23 for that serotype is greater than 0.5 (2-fold criterion).|Ratio of GMTs (20vPnC/13vPnC)|0.89|||||TWO_SIDED|95.0|0.79|0.99||||||Serotype 3: GMR (the 20vPnC/saline group to the 13vPnC/PPSV23 group) and the 2-sided 95% CI||0.99|0.79|
72623281|NCT04875533|144777288|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the ratio of GMT20vPnC/saline to GMT13vPnC/PPSV23 for that serotype is greater than 0.5 (2-fold criterion).|Ratio of GMTs (20vPnC/13vPnC)|0.79|||||TWO_SIDED|95.0|0.67|0.94||||||Serotype 4: GMR (the 20vPnC/saline group to the 13vPnC/PPSV23 group) and the 2-sided 95% CI||0.94|0.67|
72623282|NCT04875533|144777288|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the ratio of GMT20vPnC/saline to GMT13vPnC/PPSV23 for that serotype is greater than 0.5 (2-fold criterion).|Ratio of GMTs (20vPnC/13vPnC)|0.77|||||TWO_SIDED|95.0|0.65|0.91||||||Serotype 5: GMR (the 20vPnC/saline group to the 13vPnC/PPSV23 group) and the 2-sided 95% CI||0.91|0.65|
72476743|NCT01237587|144479265|SUPERIORITY||Mean Difference (Final Values)|-0.22||||0.146|TWO_SIDED|95.0|-0.52|0.08|||ANCOVA|||||0.08|-0.52|.146
72476744|NCT01237587|144479266|SUPERIORITY||Mean Difference (Final Values)|-0.01||||0.927|TWO_SIDED|95.0|-0.23|0.21|||ANCOVA|||||0.21|-0.23|.927
72476745|NCT01237587|144479267|SUPERIORITY||Mean Difference (Final Values)|1.03||||0.431|TWO_SIDED|95.0|-1.54|3.59|||ANCOVA|||||3.59|-1.54|.431
72476746|NCT01237587|144479268|SUPERIORITY||Mean Difference (Final Values)|0.92||||0.529|TWO_SIDED|95.0|-1.95|3.79|||ANCOVA|||||3.79|-1.95|.529
72476747|NCT01237587|144479269|SUPERIORITY||Mean Difference (Final Values)|-0.83||||0.335|TWO_SIDED|95.0|-2.52|0.86|||ANCOVA|||||0.86|-2.52|.335
72476748|NCT01237587|144479270|SUPERIORITY||Mean Difference (Final Values)|0.05||||0.955|TWO_SIDED|95.0|-1.59|1.68|||ANCOVA|||Physical Symptoms Score||1.68|-1.59|.955
72476749|NCT01237587|144479270|SUPERIORITY||Mean Difference (Final Values)|-0.56||||0.381|TWO_SIDED|95.0|-1.82|0.7|||ANCOVA|||Harm Avoidance||0.70|-1.82|.381
72623283|NCT04875533|144777288|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the ratio of GMT20vPnC/saline to GMT13vPnC/PPSV23 for that serotype is greater than 0.5 (2-fold criterion).|Ratio of GMTs (20vPnC/13vPnC)|0.87|||||TWO_SIDED|95.0|0.73|1.05||||||Serotype 6A: GMR (the 20vPnC/saline group to the 13vPnC/PPSV23 group) and the 2-sided 95% CI||1.05|0.73|
72476750|NCT01237587|144479270|SUPERIORITY||Mean Difference (Final Values)|-0.43||||0.486|TWO_SIDED|95.0|-1.66|0.79|||ANCOVA|||Social Anxiety||0.79|-1.66|.486
72476751|NCT01237587|144479270|SUPERIORITY||Mean Difference (Final Values)|-0.19||||0.7|TWO_SIDED|95.0|-1.17|0.79|||ANCOVA|||Separation/Panic||0.79|-1.17|.700
72476752|NCT01237587|144479270|SUPERIORITY||Mean Difference (Final Values)|-1.21||||0.54|TWO_SIDED|95.0|-5.12|2.69|||ANCOVA|||Total Score||2.69|-5.12|.540
72476753|NCT03208036|144479287|SUPERIORITY||||||=|0.69|||||||Mixed Models Analysis|||Mixed effect, repeated measure ANOVA to assess change between baseline, 4-month, and 5.5 month assessments. Test for a Group x Time interaction.||||= .69
72623284|NCT04875533|144777288|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the ratio of GMT20vPnC/saline to GMT13vPnC/PPSV23 for that serotype is greater than 0.5 (2-fold criterion).|Ratio of GMTs (20vPnC/13vPnC)|0.91|||||TWO_SIDED|95.0|0.77|1.08||||||Serotype 6B: GMR (the 20vPnC/saline group to the 13vPnC/PPSV23 group) and the 2-sided 95% CI||1.08|0.77|
72476754|NCT03208036|144479287|SUPERIORITY||||||=|0.74|||||||Mixed Models Analysis|||Mixed effect, repeated measure ANOVA to assess change between baseline, 4-month, and 5.5 month assessments. Test for a Main Effect of Time.||||= .74
72476755|NCT03208036|144479288|SUPERIORITY||||||=|0.62|||||||Mixed Models Analysis|||Mixed effect, repeated measure ANOVA to assess change between baseline, 4-month, and 5.5 month assessments. Test for a Group x Time interaction.||||= .62
72476756|NCT03208036|144479288|SUPERIORITY||||||=|0.24|||||||Mixed Models Analysis|||Mixed effect, repeated measure ANOVA to assess change between baseline, 4-month, and 5.5 month assessments. Test for a Main Effect of Time.||||= .24
72476757|NCT03208036|144479289|SUPERIORITY||||||=|0.47|||||||Mixed Models Analysis|||Mixed effect, repeated measure ANOVA to assess change between baseline, 4-month, and 5.5 month assessments. Test for a Group x Time interaction.||||= .47
72476758|NCT03208036|144479289|SUPERIORITY||||||=|0.09|||||||Mixed Models Analysis|||Mixed effect, repeated measure ANOVA to assess change between baseline, 4-month, and 5.5 month assessments. Test for a Main Effect of Time.||||= .09
72476759|NCT03208036|144479289|SUPERIORITY||||||=|0.02|||||||t-test, 2 sided|||Within group change assessed between baseline and 4-month assessment.||||= .02
72476760|NCT03208036|144479289|SUPERIORITY||||||=|0.48|||||||t-test, 2 sided|||Within group change assessed between baseline and the 5.5 month assessment.||||= .48
72476761|NCT03208036|144479289|SUPERIORITY||||||=|0.66|||||||t-test, 2 sided|||Within group change assessed between baseline and 4-month assessment.||||= .66
72476762|NCT03208036|144479289|SUPERIORITY||||||=|0.46|||||||t-test, 2 sided|||Within group change assessed between baseline and 5.5 month assessment.||||= .46
72623285|NCT04875533|144777288|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the ratio of GMT20vPnC/saline to GMT13vPnC/PPSV23 for that serotype is greater than 0.5 (2-fold criterion).|Ratio of GMTs (20vPnC/13vPnC)|0.84|||||TWO_SIDED|95.0|0.75|0.93||||||Serotype 7F: GMR (the 20vPnC/saline group to the 13vPnC/PPSV23 group) and the 2-sided 95% CI||0.93|0.75|
72623286|NCT04875533|144777288|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the ratio of GMT20vPnC/saline to GMT13vPnC/PPSV23 for that serotype is greater than 0.5 (2-fold criterion).|Ratio of GMTs (20vPnC/13vPnC)|0.88|||||TWO_SIDED|95.0|0.76|1.02||||||Serotype 9V: GMR (the 20vPnC/saline group to the 13vPnC/PPSV23 group) and the 2-sided 95% CI||1.02|0.76|
72623287|NCT04875533|144777288|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the ratio of GMT20vPnC/saline to GMT13vPnC/PPSV23 for that serotype is greater than 0.5 (2-fold criterion).|Ratio of GMTs (20vPnC/13vPnC)|1.09|||||TWO_SIDED|95.0|0.92|1.29||||||Serotype 14: GMR (the 20vPnC/saline group to the 13vPnC/PPSV23 group) and the 2-sided 95% CI||1.29|0.92|
72623288|NCT04875533|144777288|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the ratio of GMT20vPnC/saline to GMT13vPnC/PPSV23 for that serotype is greater than 0.5 (2-fold criterion).|Ratio of GMTs (20vPnC/13vPnC)|0.73|||||TWO_SIDED|95.0|0.62|0.85||||||Serotype 18C: GMR (the 20vPnC/saline group to the 13vPnC/PPSV23 group) and the 2-sided 95% CI||0.85|0.62|
72623289|NCT04875533|144777288|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the ratio of GMT20vPnC/saline to GMT13vPnC/PPSV23 for that serotype is greater than 0.5 (2-fold criterion).|Ratio of GMTs (20vPnC/13vPnC)|0.74|||||TWO_SIDED|95.0|0.63|0.86||||||Serotype 19A: GMR (the 20vPnC/saline group to the 13vPnC/PPSV23 group) and the 2-sided 95% CI||0.86|0.63|
72476763|NCT03208036|144479290|SUPERIORITY||||||=|0.68|||||||Mixed Models Analysis|||Mixed effect, repeated measure ANOVA to assess change between baseline, 4-month, and 5.5 month assessments. Test for a Group x Time interaction.||||= .68
72476764|NCT03208036|144479290|SUPERIORITY||||||=|0.45|||||||Mixed Models Analysis|||Mixed effect, repeated measure ANOVA to assess change between baseline, 4-month, and 5.5 month assessments. Test for a Main Effect of Time.||||= .45
72399450|NCT01641692|144305888|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3||||0.752|TWO_SIDED|95.0|-1.4|2.0|||Mixed Models Analysis|||||2.0|-1.4|0.752
72476765|NCT03208036|144479291|SUPERIORITY||||||=|0.81|||||||Mixed Models Analysis|||Mixed effect, repeated measure ANOVA to assess change between baseline, 4-month, and 5.5 month assessments. Test for a Group x Time interaction.||||= .81
72476766|NCT03208036|144479291|SUPERIORITY||||||=|0.31|||||||Mixed Models Analysis|||Mixed effect, repeated measure ANOVA to assess change between baseline, 4-month, and 5.5 month assessments. Test for a Main Effect of Time.||||= .31
72476767|NCT03208036|144479292|SUPERIORITY||||||=|0.79|||||||Mixed Models Analysis|||Mixed effect, repeated measure ANOVA to assess change between baseline, 4-month, and 5.5 month assessments. Test for a Group x Time interaction.||||= .79
72476768|NCT03208036|144479292|SUPERIORITY||||||=|0.5|||||||Mixed Models Analysis|||Mixed effect, repeated measure ANOVA to assess change between baseline, 4-month, and 5.5 month assessments. Test for a Main Effect of Time.||||= .50
72476769|NCT03208036|144479293|SUPERIORITY||||||=|0.47|||||||Mixed Models Analysis|||Mixed effect, repeated measure ANOVA to assess change between baseline, 4-month, and 5.5 month assessments. Test for a Group x Time interaction.||||= .47
72476770|NCT03208036|144479293|SUPERIORITY||||||=|0.09|||||||Mixed Models Analysis|||Mixed effect, repeated measure ANOVA to assess change between baseline, 4-month, and 5.5 month assessments. Test for a Main Effect of Time.||||= .09
72476771|NCT03208036|144479293|SUPERIORITY||||||=|0.02|||||||t-test, 2 sided|||Within group change assessed between baseline and 4-month assessment.||||= .02
72476772|NCT03208036|144479293|SUPERIORITY||||||=|0.48|||||||t-test, 2 sided|||Within group change assessed between baseline and the 5.5 month assessment.||||= .48
72476773|NCT03208036|144479293|SUPERIORITY||||||=|0.66|||||||t-test, 2 sided|||Within group change assessed between baseline and 4-month assessment.||||= .66
72476774|NCT03208036|144479293|SUPERIORITY||||||=|0.46|||||||t-test, 2 sided|||Within group change assessed between baseline and the 5.5 month assessment.||||= .46
72476775|NCT03208036|144479294|SUPERIORITY||||||=|0.99|||||||Mixed Models Analysis|||Mixed effect, repeated measure ANOVA to assess change between baseline, 4-month, and 5.5 month assessments. Test for a Group x Time interaction.||||= .99
72476776|NCT03208036|144479294|SUPERIORITY||||||=|0.84|||||||Mixed Models Analysis|||Mixed effect, repeated measure ANOVA to assess change between baseline, 4-month, and 5.5 month assessments. Test for a Main Effect of Time.||||= .84
72476777|NCT03208036|144479295|SUPERIORITY||||||=|0.25|||||||Mixed Models Analysis|||Mixed effect, repeated measure ANOVA to assess change between baseline, 4-month, and 5.5 month assessments. Test for a Group x Time interaction.||||= .25
72476778|NCT03208036|144479295|SUPERIORITY||||||=|0.08|||||||Mixed Models Analysis|||Mixed effect, repeated measure ANOVA to assess change between baseline, 4-month, and 5.5 month assessments. Test for a Main Effect of Time.||||= .08
72476779|NCT03208036|144479295|SUPERIORITY||||||=|0.14|||||||t-test, 2 sided|||Within group change assessed between baseline and 4-month assessment.||||= .14
72623290|NCT04875533|144777288|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the ratio of GMT20vPnC/saline to GMT13vPnC/PPSV23 for that serotype is greater than 0.5 (2-fold criterion).|Ratio of GMTs (20vPnC/13vPnC)|0.64|||||TWO_SIDED|95.0|0.53|0.76||||||Serotype 19F: GMR (the 20vPnC/saline group to the 13vPnC/PPSV23 group) and the 2-sided 95% CI||0.76|0.53|
72623291|NCT04875533|144777288|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the ratio of GMT20vPnC/saline to GMT13vPnC/PPSV23 for that serotype is greater than 0.5 (2-fold criterion).|Ratio of GMTs (20vPnC/13vPnC)|0.8|||||TWO_SIDED|95.0|0.65|0.99||||||Serotype 23F: GMR (the 20vPnC/saline group to the 13vPnC/PPSV23 group) and the 2-sided 95% CI||0.99|0.65|
72399451|NCT01641692|144305888|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.5||||0.072|TWO_SIDED|95.0|-0.1|3.2|||Mixed Models Analysis|||||3.2|-0.1|0.072
72399452|NCT01641692|144305888|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.6||||0.503|TWO_SIDED|95.0|-1.1|2.2|||Mixed Models Analysis|||||2.2|-1.1|0.503
72476780|NCT03208036|144479295|SUPERIORITY||||||=|0.02|||||||t-test, 2 sided|||Within group change assessed between baseline and 5.5-month assessment.||||= .02
72476781|NCT03208036|144479295|SUPERIORITY||||||=|0.24|||||||t-test, 2 sided|||Within group change assessed between baseline and 4-month assessment.||||= .24
72476782|NCT03208036|144479295|SUPERIORITY||||||=|0.93|||||||t-test, 2 sided|||Within group change assessed between baseline and 5.5-month assessment.||||= .93
72476783|NCT03208036|144479296|SUPERIORITY||||||=|0.98|||||||Mixed Models Analysis|||Mixed effect, repeated measure ANOVA to assess change between baseline, 4-month, and 5.5 month assessments. Test for a Group x Time interaction.||||= .98
72476784|NCT03208036|144479296|SUPERIORITY||||||=|0.08|||||||Mixed Models Analysis|||Mixed effect, repeated measure ANOVA to assess change between baseline, 4-month, and 5.5 month assessments. Test for a Main Effect of Time.||||= .08
72476785|NCT03208036|144479296|SUPERIORITY||||||=|0.08|||||||t-test, 2 sided|||Within group change assessed between baseline and 4-month assessment.||||= .08
72476786|NCT03208036|144479296|SUPERIORITY||||||=|0.06|||||||t-test, 2 sided|||Within group change assessed between baseline and 5.5-month assessment.||||= .06
72476787|NCT03208036|144479296|SUPERIORITY||||||=|0.28|||||||t-test, 2 sided|||Within group change assessed between baseline and 4-month assessment.||||= .28
72476788|NCT03208036|144479296|SUPERIORITY||||||=|0.23|||||||t-test, 2 sided|||Within group change assessed between baseline and 5.5-month assessment.||||= .23
72476789|NCT02217501|144479312|SUPERIORITY|||||||0.6595||||||Alpha of 0.05|Cochran-Mantel-Haenszel|||||||0.6595
72476790|NCT05121246|144479313|EQUIVALENCE|CI 90% of least squares geometric means must be entirely contained within the range \[80%-125%\].||||||||||||||||PK parameters will be determined using a non-compartmental analysis method. Bioequivalence between MB05 and EU-Synagis®, between MB05 and US-Synagis® and between EU-Synagis® and US-Synagis® will be established by analysis of variance for the PK parameters AUC0-inf, and Cmax.|PK parameters for each participant will be listed and summarised by treatment using descriptive statistics.|||
72476791|NCT05121246|144479314|EQUIVALENCE|CI 90% of least squares geometric means must be entirely contained within the range \[80%-125%\].||||||||||||||||PK parameters will be determined using a non-compartmental analysis method. Bioequivalence between MB05 and EU-Synagis®, between MB05 and US-Synagis® and between EU-Synagis® and US-Synagis® will be established by analysis of variance for the PK parameters AUC0-inf, and Cmax.|PK parameters for each participant will be listed and summarised by treatment using descriptive statistics.|||
72476792|NCT00435591|144479323|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.23|||||TWO_SIDED|95.0|-0.37|0.83||||||"Aggregated data were used to determine differences between groups. Statistical analysis is relevant to the aggregated data of all rows except the no assessment row."||0.83|-0.37|
72476793|NCT00210470|144479330|EQUIVALENCE|The correlation of each of the above variables at biopsy/Day 1, surgery/Day 21, and change with percent change in the longest diameter (LD) of the primary tumor was calculated using Spearman rank correlations (183 correlations). Due to outliers in the distribution of percent change in the longest diameter, it was felt that the Spearman rank correlations would be more appropriate than Pearson correlations.|||||<|0.1|||||||Spearman Rank|||||||<0.10
72508498|NCT01070550|144548030|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.739||||0.0295|TWO_SIDED|95.0|0.563|0.97|||Regression, Logistic|||The statistical analysis is presented for age per 10 years. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.970|0.563|0.0295
72566326|NCT02697773|144663265|SUPERIORITY||Odds Ratio (OR)|1.9||||0.0009|TWO_SIDED|95.0|1.3|2.78|||Regression, Logistic|||Week 2, \>=30%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.78|1.30|0.0009
72623292|NCT04875533|144777289|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the ratio of GMT20vPnC/saline to GMT13vPnC/PPSV23 for that serotype is greater than 0.5 (2-fold criterion).|Ratio of GMTs (20vPnC/PPSV23)|0.58|||||TWO_SIDED|95.0|0.5|0.67||||||Serotype 8: GMR (the 20vPnC/saline group to the 13vPnC/PPSV23 group) and the 2-sided 95% CI||0.67|0.50|
72623293|NCT04875533|144777289|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the ratio of GMT20vPnC/saline to GMT13vPnC/PPSV23 for that serotype is greater than 0.5 (2-fold criterion).|Ratio of GMTs (20vPnC/PPSV23)|2.14|||||TWO_SIDED|95.0|1.8|2.53||||||Serotype 10A: GMR (the 20vPnC/saline group to the 13vPnC/PPSV23 group) and the 2-sided 95% CI||2.53|1.80|
72476794|NCT02245737|144479339|SUPERIORITY||LS Mean Difference (Final Values)|-0.93|STANDARD_ERROR_OF_MEAN|0.77||0.232|TWO_SIDED|95.0|-2.447|0.594|||Mixed Models Analysis|||||0.594|-2.447|0.232
72399453|NCT01641692|144305888|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.6||||0.476|TWO_SIDED|95.0|-1.1|2.3|||Mixed Models Analysis|||||2.3|-1.1|0.476
72476795|NCT02245737|144479339|SUPERIORITY||LS Mean Difference (Final Values)|0.41|STANDARD_ERROR_OF_MEAN|0.78||0.599|TWO_SIDED|95.0|-1.124|1.947|||Mixed Models Analysis|||||1.947|-1.124|0.599
72476796|NCT02245737|144479340|SUPERIORITY||LS Mean Difference (Final Values)|0.03|STANDARD_ERROR_OF_MEAN|0.83||0.971|TWO_SIDED|95.0|-1.609|1.669|||Mixed Models Analysis|||||1.669|-1.609|0.971
72476797|NCT02245737|144479340|SUPERIORITY||LS Mean Difference (Final Values)|0.08|STANDARD_ERROR_OF_MEAN|0.85||0.923|TWO_SIDED|95.0|-1.58|1.743|||Mixed Models Analysis|||||1.743|-1.580|0.923
72476798|NCT02245737|144479341|SUPERIORITY||LS Mean Difference (Final Values)|-0.14|STANDARD_ERROR_OF_MEAN|0.53||0.796|TWO_SIDED|95.0|-1.172|0.899|||Mixed Models Analysis|||||0.899|-1.172|0.796
72476799|NCT02245737|144479341|SUPERIORITY||LS Mean Difference (Final Values)|0.61|STANDARD_ERROR_OF_MEAN|0.53||0.252|TWO_SIDED|95.0|-0.437|1.66|||Mixed Models Analysis|||||1.660|-0.437|0.252
72566327|NCT02697773|144663265|SUPERIORITY||Odds Ratio (OR)|1.99||||0.0004|TWO_SIDED|95.0|1.36|2.9|||Regression, Logistic|||Week 2, \>=30%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.90|1.36|0.0004
72399454|NCT01641692|144305888|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.5||||0.084|TWO_SIDED|95.0|-0.2|3.2|||Mixed Models Analysis|||||3.2|-0.2|0.084
72399455|NCT01641692|144305888|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.97|TWO_SIDED|95.0|-1.8|1.7|||Mixed Models Analysis|||||1.7|-1.8|0.970
72399456|NCT01641692|144305888|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7||||0.423|TWO_SIDED|95.0|-2.4|1.0|||Mixed Models Analysis|||||1.0|-2.4|0.423
72399457|NCT00657241|144305930|SUPERIORITY|All hemodynamic variables are continuous and all participants received both treatments, so paired-t analysis could be used. While paired t-tests do not necessarily require a power and sample size analysis, we estimated that 30 subjects were sufficient to detect an 8% difference in CTTI between comparators at p\<0.05 with a conservatively estimated power of 0.8.|||||<|0.05|||||||t-test, 2 sided|||Statistical analysis performed on treatment groups (valsartan or carvedilol CR) at end of treatment period (4 weeks), not on the randomization arms in the crossover design (which controlled for carryover effects of the prior treatment arm).||||<0.05
72399458|NCT00657241|144305932|SUPERIORITY|||||||0.05|||||||t-test, 2 sided|paired t-test||Statistical analysis performed on treatment groups (valsartan or carvedilol CR) at end of treatment period (4 weeks), not on the randomization arms in the crossover design (which controlled for carryover effects of the prior treatment arm).||||0.05
72476800|NCT02245737|144479342|SUPERIORITY||LS Mean Difference (Final Values)|1.11|STANDARD_ERROR_OF_MEAN|1.4||0.428|TWO_SIDED|95.0|-1.637|3.852|||Mixed Models Analysis|||||3.852|-1.637|0.428
72476801|NCT02245737|144479342|SUPERIORITY||LS Mean Difference (Final Values)|-0.13|STANDARD_ERROR_OF_MEAN|1.42||0.926|TWO_SIDED|95.0|-2.918|2.655|||Mixed Models Analysis|||||2.655|-2.918|0.926
72476802|NCT02245737|144479343|SUPERIORITY||LS Mean Difference (Final Values)|0.15|STANDARD_ERROR_OF_MEAN|0.24||0.533|TWO_SIDED|95.0|-0.322|0.622|||Mixed Models Analysis|||||0.622|-0.322|0.533
72476803|NCT02245737|144479343|SUPERIORITY||LS Mean Difference (Final Values)|0.15|STANDARD_ERROR_OF_MEAN|0.24||0.537|TWO_SIDED|95.0|-0.328|0.63|||Mixed Models Analysis|||||0.630|-0.328|0.537
72566328|NCT02697773|144663265|SUPERIORITY||Odds Ratio (OR)|1.95||||0.0015|TWO_SIDED|95.0|1.29|2.96|||Regression, Logistic|||Week 2, \>=50%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.96|1.29|0.0015
72399459|NCT00657241|144305933|SUPERIORITY|||||||0.05|||||||t-test, 2 sided|Paired t-test||Statistical analysis performed on treatment groups (valsartan or carvedilol CR) at end of treatment period (4 weeks), not on the randomization arms in the crossover design (which controlled for carryover effects of the prior treatment arm).||||0.05
72399460|NCT00657241|144305934|SUPERIORITY|||||||0.05|||||||t-test, 2 sided|paired t-test||Statistical analysis performed on treatment groups (valsartan or carvedilol CR) at end of treatment period (4 weeks), not on the randomization arms in the crossover design (which controlled for carryover effects of the prior treatment arm).||||0.05
72476804|NCT02245737|144479345|SUPERIORITY||LS Mean Difference (Final Values)|1.77|STANDARD_ERROR_OF_MEAN|1.13||0.116|TWO_SIDED|95.0|-0.441|3.986|||Mixed Models Analysis|||||3.986|-0.441|0.116
72476805|NCT02245737|144479345|SUPERIORITY||LS Mean Difference (Final Values)|1.45|STANDARD_ERROR_OF_MEAN|1.15||0.208|TWO_SIDED|95.0|-0.808|3.704|||Mixed Models Analysis|||||3.704|-0.808|0.208
72476806|NCT02245737|144479346|SUPERIORITY||LS Mean Difference (Final Values)|0.32|STANDARD_ERROR_OF_MEAN|0.36||0.379|TWO_SIDED|95.0|-0.391|1.027|||Mixed Models Analysis|||||1.027|-0.391|0.379
72566329|NCT02697773|144663265|SUPERIORITY||Odds Ratio (OR)|2.03||||0.0008|TWO_SIDED|95.0|1.34|3.07|||Regression, Logistic|||Week 2, \>=50%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.07|1.34|0.0008
72566330|NCT02697773|144663265|SUPERIORITY||Odds Ratio (OR)|1.72||||0.0251|TWO_SIDED|95.0|1.07|2.75|||Regression, Logistic|||Week 2, \>=70%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.75|1.07|0.0251
72399461|NCT00657241|144305935|SUPERIORITY|||||||0.05|||||||t-test, 2 sided|paired t-test||Statistical analysis performed on treatment groups (valsartan or carvedilol CR) at end of treatment period (4 weeks), not on the randomization arms in the crossover design (which controlled for carryover effects of the prior treatment arm).||||0.05
72399462|NCT00670800|144305939|SUPERIORITY_OR_OTHER|||||||0.143||95.0|||||t-test, 2 sided|||||||0.143
72399463|NCT00670800|144305939|SUPERIORITY_OR_OTHER|||||||0.9||95.0|||||t-test, 2 sided|||||||0.900
72399464|NCT00670800|144305939|SUPERIORITY_OR_OTHER|||||||0.133||95.0|||||t-test, 2 sided|||||||0.133
72566331|NCT02697773|144663265|SUPERIORITY||Odds Ratio (OR)|1.7||||0.0276|TWO_SIDED|95.0|1.06|2.72|||Regression, Logistic|||Week 2, \>=70%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.72|1.06|0.0276
72566332|NCT02697773|144663265|SUPERIORITY||Odds Ratio (OR)|1.95||||0.0404|TWO_SIDED|95.0|1.03|3.71|||Regression, Logistic|||Week 2, \>=90%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.71|1.03|0.0404
72566333|NCT02697773|144663265|SUPERIORITY||Odds Ratio (OR)|1.38||||0.3486|TWO_SIDED|95.0|0.7|2.72|||Regression, Logistic|||Week 2, \>=90%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.72|0.70|0.3486
72566334|NCT02697773|144663265|SUPERIORITY||Odds Ratio (OR)|2.07||||0.0002|TWO_SIDED|95.0|1.42|3.02|||Regression, Logistic|||Week 4, \>=30%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.02|1.42|0.0002
72566335|NCT02697773|144663265|SUPERIORITY||Odds Ratio (OR)|1.92||||0.0006|TWO_SIDED|95.0|1.32|2.79|||Regression, Logistic|||Week 4, \>=30%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.79|1.32|0.0006
72399465|NCT00670800|144305940|SUPERIORITY_OR_OTHER|||||||0.049||95.0|||||t-test, 2 sided|||||||0.049
72399466|NCT00670800|144305940|SUPERIORITY_OR_OTHER|||||||0.717||95.0|||||t-test, 2 sided|||||||0.717
72399467|NCT00670800|144305940|SUPERIORITY_OR_OTHER|||||||0.038||95.0|||||t-test, 2 sided|||||||0.038
72399468|NCT00670800|144305941|SUPERIORITY_OR_OTHER|||||||0.498||95.0|||||t-test, 2 sided|||||||0.498
72399469|NCT00670800|144305941|SUPERIORITY_OR_OTHER|||||||0.835||95.0|||||t-test, 2 sided|||||||0.835
72399470|NCT00670800|144305941|SUPERIORITY_OR_OTHER|||||||0.606||95.0|||||t-test, 2 sided|||||||0.606
72399471|NCT00670800|144305942|SUPERIORITY_OR_OTHER|||||||0.118||95.0|||||t-test, 2 sided|||||||0.118
72399472|NCT00670800|144305942|SUPERIORITY_OR_OTHER|||||||0.581||95.0|||||t-test, 2 sided|||||||0.581
72399473|NCT00670800|144305942|SUPERIORITY_OR_OTHER|||||||0.19||95.0|||||t-test, 2 sided|||||||0.190
72399474|NCT04736199|144305944|SUPERIORITY||Hazard Ratio (HR)|0.541|||<|0.0001|TWO_SIDED|95.0|0.413|0.707||One-sided|Log Rank|||Analyzed with log-rank test and Cox regression proportional hazard model, stratified by the same factor as used for randomization visceral disease (present versus absent), prior local therapy (Yes versus No).||0.707|0.413|<0.0001
72399475|NCT04736199|144305945|SUPERIORITY||Hazard Ratio (HR)|0.813||||0.1007|TWO_SIDED|95.0|0.591|1.118||One-sided|Log Rank||significance level of 0.0185 (one-sided)|Analyzed with log-rank test and Cox regression proportional hazard model, stratified by the same factor as used for randomization visceral disease (present versus absent), prior local therapy (Yes versus No).||1.118|0.591|0.1007
72399476|NCT04736199|144305946|OTHER||Hazard Ratio (HR)|0.404|||||TWO_SIDED|95.0|0.321|0.508||||||Analyzed with log-rank test and Cox regression proportional hazard model, stratified by the same factor as used for randomization visceral disease (present versus absent), prior local therapy (Yes versus No).||0.508|0.321|
72399477|NCT04736199|144305947|OTHER||Hazard Ratio (HR)|0.401|||||TWO_SIDED|95.0|0.288|0.558||||||Analyzed with log-rank test and Cox regression proportional hazard model, stratified by the same factor as used for randomization visceral disease (present versus absent), prior local therapy (Yes versus No).||0.558|0.288|
72399478|NCT04736199|144305948|OTHER||Hazard Ratio (HR)|0.306|||||TWO_SIDED|95.0|0.231|0.405||||||Analyzed with log-rank test and Cox regression proportional hazard model, stratified by the same factor as used for randomization visceral disease (present versus absent), prior local therapy (Yes versus No).||0.405|0.231|
72399479|NCT04736199|144305949|OTHER||Rate difference|44.3|||||TWO_SIDED|95.0|37.4|51.2||||||Analyzed with log-rank test and Cox regression proportional hazard model, stratified by the same factor as used for randomization visceral disease (present versus absent), prior local therapy (Yes versus No).||51.2|37.4|
72399480|NCT04736199|144305950|OTHER||Hazard Ratio (HR)|0.721|||||TWO_SIDED|95.0|0.544|0.957||||||Analyzed with log-rank test and Cox regression proportional hazard model, stratified by the same factor as used for randomization visceral disease (present versus absent), prior local therapy (Yes versus No).||0.957|0.544|
72399481|NCT04318080|144305952|SUPERIORITY|Analysis tested whether ORR with tislelizumab was superior to a historical ORR of 45% using a one-sided binomial exact test (α = 0.05).|Z-test|2.62||||0.0044|TWO_SIDED|||||One-sided p-value based on a binomial exact test comparing observed ORR to historical rate of 45%.|Binomial Exact Test|||The primary analysis was conducted on both cohorts combined, A binomial exact test was performed to test the null hypothesis (H0: ORR = 45% based on previous clinical trials) and alternative hypothesis (ORR \>45%). If the one-sided p-value was ≤ 0.05, tislelizumab was considered to statistically significantly increase ORR compared to the historical control.||||0.0044
72399482|NCT00861146|144305988|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.01|||||||Chi-squared|df = 1||||||<.01
72399483|NCT00861146|144305989|SUPERIORITY_OR_OTHER_LEGACY||mixed model regression analyses (F)|2.04|||>|0.15|||||||mixed model regression analyses|||Drinking outcomes assessed using the timeline follow-back were evaluated with mixed model regression analyses using maximum likelihood estimation. Time was measured in three monthly periods and treated as a repeated factor (due to the fixed time period between estimates).||||> .15
72399484|NCT00861146|144305990|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Chi-squared|df=1||||||<.001
72399485|NCT02981342|144305991|SUPERIORITY|||||||0.0495|||||||Cochran-Mantel-Haenszel|||||||0.0495
72399486|NCT02981342|144305991|SUPERIORITY|||||||0.023|||||||Cochran-Mantel-Haenszel|||||||0.0230
72399487|NCT02981342|144305992|SUPERIORITY|||||||0.0085|||||||Log Rank|||||||0.0085
72399488|NCT02981342|144305992|SUPERIORITY|||||||0.0123|||||||Log Rank|||||||0.0123
72399489|NCT02981342|144305993|SUPERIORITY|||||||1|||||||Cochran-Mantel-Haenszel|||||||1
72399490|NCT02981342|144305993|SUPERIORITY|||||||0.3017|||||||Cochran-Mantel-Haenszel|||||||0.3017
72399491|NCT02981342|144305998|SUPERIORITY|||||||1|||||||Cochran-Mantel-Haenszel|||||||1
72399492|NCT02981342|144305998|SUPERIORITY|||||||0.3017|||||||Cochran-Mantel-Haenszel|||||||0.3017
72399493|NCT02981342|144306000|SUPERIORITY||Hazard Ratio (HR)|1.6||||0.1938|TWO_SIDED|95.0|0.782|3.272|||Log Rank|||||3.272|0.782|0.1938
72399494|NCT02981342|144306000|SUPERIORITY||Hazard Ratio (HR)|1.533||||0.2477|TWO_SIDED|95.0|0.746|3.15|||Log Rank|||||3.150|0.746|0.2477
72399495|NCT02981342|144306002|SUPERIORITY||LSMean Difference|0.65|STANDARD_ERROR_OF_MEAN|0.74||0.383|TWO_SIDED|95.0|-0.84|2.13|||Mixed Models Analysis|||Pain at its Worst in Last 24 Hours||2.13|-0.84|0.383
72399496|NCT02981342|144306002|SUPERIORITY||LSMean Difference|-0.31|STANDARD_ERROR_OF_MEAN|0.79||0.692|TWO_SIDED|95.0|-1.91|1.28|||Mixed Models Analysis|||Pain at its Worst in Last 24 Hours||1.28|-1.91|0.692
72399497|NCT02981342|144306002|SUPERIORITY||LSMean Difference|0.48|STANDARD_ERROR_OF_MEAN|0.66||0.469|TWO_SIDED|95.0|-0.85|1.8|||Mixed Models Analysis|||Pain at its Least in Last 24 Hours||1.80|-0.85|0.469
72399498|NCT02981342|144306002|SUPERIORITY||LSMean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.7||0.776|TWO_SIDED|95.0|-1.62|1.22|||Mixed Models Analysis|||Pain at its Least in Last 24 Hours||1.22|-1.62|0.776
72399499|NCT02981342|144306002|SUPERIORITY||LSMean Difference|0.69|STANDARD_ERROR_OF_MEAN|0.7||0.328|TWO_SIDED|95.0|-0.72|2.11|||Mixed Models Analysis|||Pain on the Average||2.11|-0.72|0.328
72399500|NCT02981342|144306002|SUPERIORITY||LSMean Difference|0.04|STANDARD_ERROR_OF_MEAN|0.74||0.954|TWO_SIDED|95.0|-1.45|1.54|||Mixed Models Analysis|||Pain on the Average||1.54|-1.45|0.954
72399501|NCT02981342|144306002|SUPERIORITY||LSMean Difference|0.75|STANDARD_ERROR_OF_MEAN|0.8||0.35|TWO_SIDED|95.0|-0.85|2.36|||Mixed Models Analysis|||Pain Right Now||2.36|-0.85|0.350
72399502|NCT02981342|144306002|SUPERIORITY||LSMean Difference|0.72|STANDARD_ERROR_OF_MEAN|0.85||0.405|TWO_SIDED|95.0|-1.01|2.44|||Mixed Models Analysis|||Pain right now.||2.44|-1.01|0.405
72399503|NCT02981342|144306002|SUPERIORITY||LSMean Difference|0.43|STANDARD_ERROR_OF_MEAN|0.73||0.565|TWO_SIDED|95.0|-1.06|1.91|||Mixed Models Analysis|||Pain Interfered General Activity||1.91|-1.06|0.565
72399504|NCT02981342|144306002|SUPERIORITY||LSMean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.79||0.848|TWO_SIDED|95.0|-1.74|1.43|||Mixed Models Analysis|||Pain Interfered General Activity||1.43|-1.74|0.848
72399505|NCT02981342|144306002|SUPERIORITY||LSMean Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.65||0.928|TWO_SIDED|95.0|-1.37|1.25|||Mixed Models Analysis|||Pain Interfered with Mood||1.25|-1.37|0.928
72399506|NCT02981342|144306002|SUPERIORITY||LSMean Difference|-0.32|STANDARD_ERROR_OF_MEAN|0.69||0.65|TWO_SIDED|95.0|-1.71|1.08|||Mixed Models Analysis|||Pain Interfered with Mood||1.08|-1.71|0.650
72399507|NCT02981342|144306002|SUPERIORITY||LSMean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.86||0.865|TWO_SIDED|95.0|-1.89|1.6|||Mixed Models Analysis|||Pain Interfered Walking Ability||1.60|-1.89|0.865
72399508|NCT02981342|144306002|SUPERIORITY||LSMean Difference|0.63|STANDARD_ERROR_OF_MEAN|0.92||0.497|TWO_SIDED|95.0|-1.23|2.5|||Mixed Models Analysis|||Pain Interfered Walking Ability||2.50|-1.23|0.497
72399509|NCT02981342|144306002|SUPERIORITY||LSMean Difference|0.89|STANDARD_ERROR_OF_MEAN|0.8||0.272|TWO_SIDED|95.0|-0.72|2.5|||Mixed Models Analysis|||Pain Interfered with Normal Work||2.50|-0.72|0.272
72399510|NCT02981342|144306002|SUPERIORITY||LSMean Difference|0.47|STANDARD_ERROR_OF_MEAN|0.85||0.583|TWO_SIDED|95.0|-1.25|2.19|||Mixed Models Analysis|||Pain Interfered with Normal Work||2.19|-1.25|0.583
72399511|NCT02981342|144306002|SUPERIORITY||LSMean Difference|0.13|STANDARD_ERROR_OF_MEAN|0.82||0.876|TWO_SIDED|95.0|-1.53|1.79|||Mixed Models Analysis|||Pain Interfered with Relations||1.79|-1.53|0.876
72399512|NCT02981342|144306002|SUPERIORITY||LSMean Difference|0.41|STANDARD_ERROR_OF_MEAN|0.88||0.644|TWO_SIDED|95.0|-1.37|2.19|||Mixed Models Analysis|||Pain Interfered with relations.||2.19|-1.37|0.644
72399513|NCT02981342|144306002|SUPERIORITY||LSMean Difference|0.75|STANDARD_ERROR_OF_MEAN|0.85||0.384|TWO_SIDED|95.0|-0.97|2.48|||Mixed Models Analysis|||Pain Interfered with Sleep||2.48|-0.97|0.384
72399514|NCT02981342|144306002|SUPERIORITY||LSMean Difference|0.9|STANDARD_ERROR_OF_MEAN|0.89||0.318|TWO_SIDED|95.0|-0.9|2.71|||Mixed Models Analysis|||||2.71|-0.90|0.318
72399515|NCT02981342|144306002|SUPERIORITY||LSMean Difference|0.81|STANDARD_ERROR_OF_MEAN|0.97||0.407|TWO_SIDED|95.0|-1.15|2.78|||Mixed Models Analysis|||Pain Interfered Enjoyment of Life||2.78|-1.15|0.407
72399516|NCT02981342|144306002|SUPERIORITY||LSMean Difference|0.52|STANDARD_ERROR_OF_MEAN|1.04||0.62|TWO_SIDED|95.0|-1.58|2.62|||Mixed Models Analysis|||Pain Interfered Enjoyment of Life||2.62|-1.58|0.620
72399517|NCT02981342|144306002|SUPERIORITY||LSMean Difference|0.5|STANDARD_ERROR_OF_MEAN|0.7||0.475|TWO_SIDED|95.0|-0.9|1.91|||Mixed Models Analysis|||BPI-Mean Interference Score||1.91|-0.90|0.475
72399518|NCT02981342|144306002|SUPERIORITY||LSMean Difference|0.46|STANDARD_ERROR_OF_MEAN|0.74||0.54|TWO_SIDED|95.0|-1.04|1.96|||Mixed Models Analysis|||BPI-Mean Interference Score||1.96|-1.04|0.540
72399519|NCT02981342|144306003|SUPERIORITY||LSMean Difference|-1.39|STANDARD_ERROR_OF_MEAN|5.98||0.818|TWO_SIDED|95.0|-13.46|10.68|||Mixed Models Analysis|||Global health status||10.68|-13.46|0.818
72476807|NCT02245737|144479346|SUPERIORITY||LS Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.37||0.992|TWO_SIDED|95.0|-0.714|0.721|||Mixed Models Analysis|||||0.721|-0.714|0.992
72508499|NCT01070550|144548030|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.166|||<|0.0001|TWO_SIDED|95.0|0.083|0.329|||Regression, Logistic|||The statistical analysis is presented for sex (male vs female). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.329|0.083|<0.0001
72508500|NCT01070550|144548030|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.049||||0.0048|TWO_SIDED|95.0|1.015|1.084|||Regression, Logistic|||The statistical analysis is presented for treatment duration after VR in weeks. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.084|1.015|0.0048
72566336|NCT02697773|144663265|SUPERIORITY||Odds Ratio (OR)|2.07||||0.0002|TWO_SIDED|95.0|1.41|3.05|||Regression, Logistic|||Week 4, \>=50%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.05|1.41|0.0002
72399520|NCT02981342|144306003|SUPERIORITY||LSMean Difference|-3.8|STANDARD_ERROR_OF_MEAN|6.06||0.533|TWO_SIDED|95.0|-16.03|8.42|||Mixed Models Analysis|||Global health status||8.42|-16.03|0.533
72399521|NCT02981342|144306003|SUPERIORITY||LSMean Difference|-2.79|STANDARD_ERROR_OF_MEAN|6.75||0.681|TWO_SIDED|95.0|-16.4|10.82|||Mixed Models Analysis|||Functional Scales: Physical functioning||10.82|-16.40|0.681
72399522|NCT02981342|144306003|SUPERIORITY||LSMean Difference|-9.02|STANDARD_ERROR_OF_MEAN|6.75||0.189|TWO_SIDED|95.0|-22.63|4.59|||Mixed Models Analysis|||Functional Scales: Physical functioning||4.59|-22.63|0.189
72399523|NCT02981342|144306003|SUPERIORITY||LSMean Difference|0.96|STANDARD_ERROR_OF_MEAN|9.54||0.921|TWO_SIDED|95.0|-18.29|20.21|||Mixed Models Analysis|||Functional Scales: Role functioning||20.21|-18.29|0.921
72399524|NCT02981342|144306003|SUPERIORITY||LSMean Difference|0.01|STANDARD_ERROR_OF_MEAN|9.62||0.999|TWO_SIDED|95.0|-19.4|19.42|||Mixed Models Analysis|||Functional Scales: Role functioning.||19.42|-19.40|0.999
72399525|NCT02981342|144306003|SUPERIORITY||LSMean Difference|-4.26|STANDARD_ERROR_OF_MEAN|6.91||0.541|TWO_SIDED|95.0|-18.2|9.68|||Mixed Models Analysis|||Functional Scales: Emotional functioning||9.68|-18.20|0.541
72399526|NCT02981342|144306003|SUPERIORITY||LSMean Difference|-6.95|STANDARD_ERROR_OF_MEAN|7.05||0.33|TWO_SIDED|95.0|-21.17|7.27|||Mixed Models Analysis|||Functional Scales: Emotional functioning||7.27|-21.17|0.330
72399527|NCT02981342|144306003|SUPERIORITY||LSMean Difference|-2.04|STANDARD_ERROR_OF_MEAN|6.29||0.747|TWO_SIDED|95.0|-14.74|10.66|||Mixed Models Analysis|||Functional Scales: Cognitive Functioning||10.66|-14.74|0.747
72399528|NCT02981342|144306003|SUPERIORITY||LSMean Difference|-5.25|STANDARD_ERROR_OF_MEAN|6.43||0.419|TWO_SIDED|95.0|-18.22|7.73|||Mixed Models Analysis|||Functional Scales: Cognitive functioning||7.73|-18.22|0.419
72566337|NCT02697773|144663265|SUPERIORITY||Odds Ratio (OR)|2.15|||<|0.0001|TWO_SIDED|95.0|1.46|3.15|||Regression, Logistic|||Week 4, \>=50%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.15|1.46|<.0001
72566338|NCT02697773|144663265|SUPERIORITY||Odds Ratio (OR)|2.02||||0.0024|TWO_SIDED|95.0|1.28|3.18|||Regression, Logistic|||Week 4, \>=70%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.18|1.28|0.0024
72566339|NCT02697773|144663265|SUPERIORITY||Odds Ratio (OR)|2.13||||0.0011|TWO_SIDED|95.0|1.35|3.34|||Regression, Logistic|||Week 4, \>=70%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.34|1.35|0.0011
72476808|NCT02245737|144479347|SUPERIORITY||LS Mean Difference (Final Values)|-51.27|STANDARD_ERROR_OF_MEAN|2.89|<|0.001|TWO_SIDED|95.0|-56.963|-45.578|||ANCOVA|||||-45.578|-56.963|<0.001
72476809|NCT02245737|144479347|SUPERIORITY||LS Mean Difference (Final Values)|-65.48|STANDARD_ERROR_OF_MEAN|2.77|<|0.001|TWO_SIDED|95.0|-70.947|-60.022|||ANCOVA|||||-60.022|-70.947|<0.001
72476810|NCT02245737|144479348|SUPERIORITY||LS Mean Difference (Final Values)|-57.99|STANDARD_ERROR_OF_MEAN|2.47|<|0.001|TWO_SIDED|95.0|-62.865|-53.108|||ANCOVA|||||-53.108|-62.865|<0.001
72476811|NCT02245737|144479348|SUPERIORITY||LS Mean Difference (Final Values)|-73.25|STANDARD_ERROR_OF_MEAN|2.37|<|0.001|TWO_SIDED|95.0|-77.926|-68.575|||ANCOVA|||||-68.575|-77.926|<0.001
72476812|NCT02245737|144479349|SUPERIORITY||LS Mean Difference (Final Values)|-19.87|STANDARD_ERROR_OF_MEAN|11.33||0.081|TWO_SIDED|95.0|-42.21|2.464|||ANCOVA|||||2.464|-42.210|0.081
72476813|NCT02245737|144479349|SUPERIORITY||LS Mean Difference (Final Values)|-15.31|STANDARD_ERROR_OF_MEAN|10.78||0.157|TWO_SIDED|95.0|-36.555|5.938|||ANCOVA|||||5.938|-36.555|0.157
72476814|NCT02245737|144479350|SUPERIORITY||LS Mean Difference (Final Values)|-2.62|STANDARD_ERROR_OF_MEAN|1.33||0.05|TWO_SIDED|95.0|-5.243|-0.002|||ANCOVA|||||-0.002|-5.243|0.050
72476815|NCT02245737|144479350|SUPERIORITY||LS Mean Difference (Final Values)|-2.12|STANDARD_ERROR_OF_MEAN|1.27||0.095|TWO_SIDED|95.0|-4.618|0.373|||ANCOVA|||||0.373|-4.618|0.095
72476816|NCT02245737|144479351|SUPERIORITY||LS Mean Difference (Final Values)|-13.68|STANDARD_ERROR_OF_MEAN|2.6|<|0.001|TWO_SIDED|95.0|-18.785|-8.574|||ANCOVA|||||-8.574|-18.785|<0.001
72476817|NCT02245737|144479351|SUPERIORITY||LS Mean Difference (Final Values)|-17.66|STANDARD_ERROR_OF_MEAN|2.66|<|0.001|TWO_SIDED|95.0|-22.887|-12.428|||ANCOVA|||||-12.428|-22.887|<0.001
72476818|NCT02245737|144479352|SUPERIORITY||LS Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.01||0.426|TWO_SIDED|95.0|-0.033|0.014|||ANCOVA|||||0.014|-0.033|0.426
72476819|NCT02245737|144479352|SUPERIORITY||LS Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.01||0.66|TWO_SIDED|95.0|-0.029|0.018|||ANCOVA|||||0.018|-0.029|0.660
72476820|NCT02245737|144479353|SUPERIORITY||LS Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.0||0.21|TWO_SIDED|95.0|-0.015|0.003|||ANCOVA|||||0.003|-0.015|0.210
72476821|NCT02245737|144479353|SUPERIORITY||LS Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.0||0.568|TWO_SIDED|95.0|-0.013|0.007|||ANCOVA|||||0.007|-0.013|0.568
72476822|NCT02245737|144479354|SUPERIORITY||LS Mean Difference (Final Values)|-2.34|STANDARD_ERROR_OF_MEAN|0.47|<|0.001|TWO_SIDED|95.0|-3.258|-1.413|||ANCOVA|||||-1.413|-3.258|<0.001
72476823|NCT02245737|144479354|SUPERIORITY||LS Mean Difference (Final Values)|-3.18|STANDARD_ERROR_OF_MEAN|0.48|<|0.001|TWO_SIDED|95.0|-4.118|-2.247|||ANCOVA|||||-2.247|-4.118|<0.001
72476824|NCT00768079|144479421|SUPERIORITY_OR_OTHER_LEGACY|||||||0.312|||||||Fisher Exact|||Non-adjudicated exacerbations: Fisher's exact test was used for statistical analysis.||||0.312
72476825|NCT00768079|144479421|SUPERIORITY_OR_OTHER_LEGACY|||||||1|||||||Fisher Exact|||Non-adjudicated exacerbations: Fisher's exact test was used for statistical analysis.||||1.000
72476826|NCT00768079|144479421|SUPERIORITY_OR_OTHER_LEGACY|||||||0.312|||||||Fisher Exact|||Adjudicated exacerbations: Fisher's exact test was used for statistical analysis.||||0.312
72476827|NCT00768079|144479421|SUPERIORITY_OR_OTHER_LEGACY|||||||1|||||||Fisher Exact|||Adjudicated exacerbations: Fisher's exact test was used for statistical analysis.||||1.000
72476828|NCT00768079|144479423|SUPERIORITY_OR_OTHER_LEGACY|||||||0.343|||||||Fisher Exact|||Week 4, non-adjudicated exacerbations: Fisher's exact test was used for statistical analysis.||||0.343
72476829|NCT00768079|144479423|SUPERIORITY_OR_OTHER_LEGACY|||||||1|||||||Fisher Exact|||Week 4, non-adjudicated exacerbations: Fisher's exact test was used for statistical analysis.||||1.000
72476830|NCT00768079|144479423|SUPERIORITY_OR_OTHER_LEGACY|||||||0.343|||||||Fisher Exact|||Week 4, adjudicated exacerbations: Fisher's exact test was used for statistical analysis.||||0.343
72476831|NCT00768079|144479423|SUPERIORITY_OR_OTHER_LEGACY|||||||1|||||||Fisher Exact|||Week 4, adjudicated exacerbations: Fisher's exact test was used for statistical analysis.||||1.000
72476832|NCT00768079|144479423|SUPERIORITY_OR_OTHER_LEGACY|||||||0.474|||||||Fisher Exact|||Week 24, non-adjudicated exacerbations: Fisher's exact test was used for statistical analysis.||||0.474
72476833|NCT00768079|144479423|SUPERIORITY_OR_OTHER_LEGACY|||||||1|||||||Fisher Exact|||Week 24, non-adjudicated exacerbations: Fisher's exact test was used for statistical analysis.||||1.000
72476834|NCT00768079|144479423|SUPERIORITY_OR_OTHER_LEGACY|||||||0.474|||||||Fisher Exact|||Week 24, adjudicated exacerbations: Fisher's exact test was used for statistical analysis.||||0.474
72476835|NCT00768079|144479423|SUPERIORITY_OR_OTHER_LEGACY|||||||1|||||||Fisher Exact|||Week 24, adjudicated exacerbations: Fisher's exact test was used for statistical analysis.||||1.000
72476836|NCT02029872|144479469|OTHER|The study was powered for enrollment of 100 subjects with MRSA colonization at baseline. Despite substantial screening, we were unable to enroll enough subjects to meet the necessary sample size.||||||||||||||||Due to low enrollment in the intervention, statistical analysis was not possible.|The study was powered for enrollment of 100 subjects with MRSA colonization at baseline. Despite substantial screening, we were unable to enroll enough subjects to meet the necessary sample size.|||
72476837|NCT05383508|144479470|OTHER||Geometric LS Mean Ratio (%)|17.05|||||TWO_SIDED|95.0|10.69|27.19||95% confidence intervals are provided for this analysis.|Mixed Models Analysis|The model included terms for sequence, period, and product exposure as fixed effects and subject as a categorical random effect.|Analysis was performed on log transformed data with Kenward Roger degrees of freedom approximation. Ratio and related 95% CI were derived by exponentiating the estimates obtained on the log scale.|The objective of this study was to determine the Cmax ratio of P4M3 variants:Cigarettes along with the corresponding 95% confidence intervals||27.19|10.69|
72476838|NCT05383508|144479470|OTHER||Geometric LS Mean Ratio (%)|19.47|||||TWO_SIDED|95.0|11.89|31.87||95% confidence intervals are provided for this analysis.|Mixed Models Analysis|The model included terms for sequence, period, and product exposure as fixed effects and subject as a categorical random effect.|Analysis was performed on log transformed data with Kenward Roger degrees of freedom approximation. Ratio and related 95% CI were derived by exponentiating the estimates obtained on the log scale.|The objective of this study was to determine the Cmax ratio of P4M3 variants:Cigarettes along with the corresponding 95% confidence intervals||31.87|11.89|
72476839|NCT05383508|144479471|OTHER||Median Difference (Net)|3.0|||||TWO_SIDED|95.0|0.0|11.0||95% confidence intervals are provided for this analysis.|Wilcoxon signed rank test||Hodges-Lehmann estimator of location shift and Moses 95% CI|The objective of this study was to determine the Tmax difference of P4M3 variants:Cigarettes along with the corresponding 95% confidence intervals||11.00|0.00|
72476840|NCT05383508|144479471|OTHER||Mean Difference (Net)|2.0|||||TWO_SIDED|95.0|0.0|4.0||95% confidence intervals are provided for this analysis.|Wilcoxon signed rank test||Hodges-Lehmann estimator of location shift and Moses 95% CI|The objective of this study was to determine the Tmax difference of P4M3 variants:Cigarettes along with the corresponding 95% confidence intervals||4.00|0.00|
72476841|NCT05383508|144479472|OTHER||Geometric LS Mean Ratio (%)|28.29|||||TWO_SIDED|95.0|16.0|50.04||95% confidence intervals are provided for this analysis.|Mixed Models Analysis|The model included terms for sequence, period, and product exposure as fixed effects and subject as a categorical random effect.|Analysis was performed on log transformed data with Kenward Roger degrees of freedom approximation. Ratio and related 95% CI were derived by exponentiating the estimates obtained on the log scale.|The objective of this study was to determine the AUC0-infinity ratio of P4M3 variants:Cigarettes along with the corresponding 95% confidence intervals||50.04|16.00|
72476842|NCT05383508|144479472|OTHER||Geometric LS Mean Ratio (%)|26.16|||||TWO_SIDED|95.0|12.74|53.69||95% confidence intervals are provided for this analysis.|Mixed Models Analysis|The model included terms for sequence, period, and product exposure as fixed effects and subject as a categorical random effect.|Analysis was performed on log transformed data with Kenward Roger degrees of freedom approximation. Ratio and related 95% CI were derived by exponentiating the estimates obtained on the log scale.|The objective of this study was to determine the AUC0-infinity ratio of P4M3 variants:Cigarettes along with the corresponding 95% confidence intervals||53.69|12.74|
72476843|NCT05383508|144479473|OTHER||Geometric LS Mean Ratio (%)|10.84|||||TWO_SIDED|95.0|5.57|21.1||95% confidence intervals are provided for this analysis.|Mixed Models Analysis|The model included terms for sequence, period, and product exposure as fixed effects and subject as a categorical random effect.|Analysis was performed on log transformed data with Kenward Roger degrees of freedom approximation. Ratio and related 95% CI were derived by exponentiating the estimates obtained on the log scale.|The objective of this study was to determine the maximum ratio of background-corrected concentration over time of P4M3 variants:Cigarettes along with the corresponding 95% confidence intervals||21.10|5.57|
72476844|NCT05383508|144479473|OTHER||Geometric LS Mean Ratio (%)|16.83|||||TWO_SIDED|95.0|9.93|28.53||95% confidence intervals are provided for this analysis.|Mixed Models Analysis|The model included terms for sequence, period, and product exposure as fixed effects and subject as a categorical random effect.|Analysis was performed on log transformed data with Kenward Roger degrees of freedom approximation. Ratio and related 95% CI were derived by exponentiating the estimates obtained on the log scale.|The objective of this study was to determine the maximum ratio of background-corrected concentration over time of P4M3 variants:Cigarettes along with the corresponding 95% confidence intervals||28.53|9.93|
72476845|NCT03412747|144479480|NON_INFERIORITY|The evaluation of non-inferiority is tested at a 1-sided alpha level of 0.025 and based on a 1-sided 97.5% CI and a non-inferiority margin of 10%.|Risk Difference (RD)|39.3|||||TWO_SIDED|95.0|30.9|47.7||||||Risk Difference: BKZ-ADA calculated using stratified CMH.||47.7|30.9|
72476846|NCT03412747|144479480|SUPERIORITY||Odds Ratio (OR)|7.459|||<|0.001|TWO_SIDED|95.0|4.709|11.816||P-values for the comparison of treatment groups were based on the CMH test from the general association.|Cochran-Mantel-Haenszel|||Odds ratio: BKZ/ADA calculated using stratified Cochran-Mantel-Haenszel (CMH) test with region and prior biologic exposure as stratification variables.||11.816|4.709|<0.001
72476847|NCT03412747|144479481|NON_INFERIORITY|The evaluation of non-inferiority is tested at a 1-sided alpha level of 0.025 and based on a 1-sided 97.5% CI and a non-inferiority margin of 10%.|Risk Difference (RD)|28.2|||||TWO_SIDED|95.0|19.7|36.7||||||Risk Difference: BKZ-ADA calculated using stratified CMH.||36.7|19.7|
72476848|NCT03412747|144479481|SUPERIORITY||Odds Ratio (OR)|4.341|||<|0.001|TWO_SIDED|95.0|2.785|6.765||P-values for the comparison of treatment groups were based on the CMH test from the general association.|Cochran-Mantel-Haenszel|||Odds ratio: BKZ/ADA calculated using stratified Cochran-Mantel-Haenszel (CMH) test with region and prior biologic exposure as stratification variables.||6.765|2.785|<0.001
72476849|NCT03412747|144479482|SUPERIORITY||Odds Ratio (OR)|6.231|||<|0.001|TWO_SIDED|95.0|3.515|11.046||P-values for the comparison of treatment groups were based on the CMH test from the general association.|Cochran-Mantel-Haenszel|||Odds ratio: BKZ/ADA calculated using stratified Cochran-Mantel-Haenszel (CMH) test with region and prior biologic exposure as stratification variables.||11.046|3.515|<0.001
72476850|NCT03412747|144479482|SUPERIORITY||Odds Ratio (OR)|5.75|||<|0.001|TWO_SIDED|95.0|3.657|9.041||P-values for the comparison of treatment groups were based on the CMH test from the general association.|Cochran-Mantel-Haenszel|||Odds ratio: BKZ/ADA calculated using stratified CMH test with region and prior biologic exposure as stratification variables.||9.041|3.657|<0.001
72399529|NCT02981342|144306003|SUPERIORITY||LSMean Difference|-4.02|STANDARD_ERROR_OF_MEAN|7.53||0.596|TWO_SIDED|95.0|-19.23|11.19|||Mixed Models Analysis|||Functional Scales: Social functioning||11.19|-19.23|0.596
72476851|NCT03412747|144479483|SUPERIORITY||Odds Ratio (OR)|4.724|||<|0.001|TWO_SIDED|95.0|2.683|8.318||P-values for the comparison of treatment groups were based on the CMH test from the general association.|Cochran-Mantel-Haenszel|||Odds ratio: BKZ/ADA calculated using stratified Cochran-Mantel-Haenszel (CMH) test with region and prior biologic exposure as stratification variables.||8.318|2.683|<0.001
72399530|NCT02981342|144306003|SUPERIORITY||LSMean Difference|-19.12|STANDARD_ERROR_OF_MEAN|7.71||0.017|TWO_SIDED|95.0|-34.68|-3.55|||Mixed Models Analysis|||Functional Scales: Social functioning||-3.55|-34.68|0.017
72399531|NCT02981342|144306003|SUPERIORITY||LSMean Difference|-0.77|STANDARD_ERROR_OF_MEAN|7.57||0.919|TWO_SIDED|95.0|-16.03|14.49||Social Scales: Fatigue|Mixed Models Analysis|||Symptoms Scales: Fatigue||14.49|-16.03|0.919
72476852|NCT03412747|144479483|SUPERIORITY||Odds Ratio (OR)|4.762|||<|0.001|TWO_SIDED|95.0|3.014|7.523||P-values for the comparison of treatment groups were based on the CMH test from the general association.|Cochran-Mantel-Haenszel|||Odds ratio: BKZ/ADA calculated using stratified CMH test with region and prior biologic exposure as stratification variables.||7.523|3.014|<0.001
72476853|NCT03412747|144479484|SUPERIORITY||Odds Ratio (OR)|7.103|||<|0.001|TWO_SIDED|95.0|4.637|10.88||P-values for the comparison of treatment groups were based on the CMH test from the general association.|Cochran-Mantel-Haenszel|||Odds ratio: BKZ/ADA calculated using stratified Cochran-Mantel-Haenszel (CMH) test with region and prior biologic exposure as stratification variables.||10.880|4.637|<0.001
72476854|NCT03412747|144479485|SUPERIORITY||Odds Ratio (OR)|4.974|||<|0.001|TWO_SIDED|95.0|3.23|7.661||P-values for the comparison of treatment groups were based on the CMH test from the general association.|Cochran-Mantel-Haenszel|||Odds ratio: BKZ/ADA calculated using stratified Cochran-Mantel-Haenszel (CMH) test with region and prior biologic exposure as stratification variables.||7.661|3.230|<0.001
72476855|NCT03412747|144479486|SUPERIORITY||Odds Ratio (OR)|5.249|||<|0.001|TWO_SIDED|95.0|3.207|8.593||P-values for the comparison of treatment groups were based on the CMH test from the general association.|Cochran-Mantel-Haenszel|||Odds ratio: BKZ/ADA calculated using stratified Cochran-Mantel-Haenszel (CMH) test with region and prior biologic exposure as stratification variables.||8.593|3.207|<0.001
72508501|NCT01070550|144548030|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|7.797||||0.0019|TWO_SIDED|95.0|2.136|28.458|||Regression, Logistic|||The statistical analysis is presented for cumulative PEG-IFN alfa-2a dose per 1000 ug, first 12 weeks. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||28.458|2.136|0.0019
72476856|NCT03412747|144479486|SUPERIORITY||Odds Ratio (OR)|4.974|||<|0.001|TWO_SIDED|95.0|3.257|7.594||P-values for the comparison of treatment groups were based on the CMH test from the general association.|Cochran-Mantel-Haenszel|||Odds ratio: BKZ/ADA calculated using stratified CMH test with region and prior biologic exposure as stratification variables.||7.594|3.257|<0.001
72476857|NCT02081417|144479495|NON_INFERIORITY|Based on the PCL-C if the interventions fell within 2.5 points of each other|Mean Difference (Net)|0.18||||0.01|TWO_SIDED|95.0|-3.4|3.8|||Mixed Models Analysis|||||3.8|-3.4|0.01
72476858|NCT03097484|144479501|SUPERIORITY|||||||0.03|||||||t-test, 2 sided|||||||0.03
72476859|NCT03097484|144479502|SUPERIORITY|||||||0.05||||||0.05 is the calculated p-value (not the threshold for statistical significance)|t-test, 2 sided|||||||0.05
72476860|NCT00468104|144479525|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Chi-squared|||A univariate analysis was done to identify possible predictors of successful resolution of symptoms. The chi-square analysis was used to compare the percent successful.||||<0.001
72476861|NCT02327351|144479581|SUPERIORITY||survival distribution function|86.0||||0.95|TWO_SIDED|95.0|79.0|94.0|||Gray test|||||94|79|0.95
72476862|NCT02327351|144479587|SUPERIORITY|||||||0.35|||||||Log Rank|||||||0.35
72399532|NCT02981342|144306003|SUPERIORITY||LSMean Difference|8.48|STANDARD_ERROR_OF_MEAN|7.54||0.267|TWO_SIDED|95.0|-6.72|23.69|||Mixed Models Analysis|||Symptom Scales: Fatigue||23.69|-6.72|0.267
72476863|NCT03988920|144479588|SUPERIORITY||Odds Ratio (OR)|0.9||||0.7439|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.7439
72476864|NCT02656329|144479591|NON_INFERIORITY|Non-inferiority of AdreView™ group over SoC group was demonstrated if upper bound of the 95% confidence interval (CI) for the hazard ratio (HR) (AdreView™ group / SoC) was equal to 1.20.|Hazard Ratio (HR)|1.047||||0.8459|TWO_SIDED|95.0|0.295|3.719||Threshold for significance at 0.025 level.|Log Rank||AdreView™ vs. Standard of Care|Analysis was performed using the Cox proportional hazards model stratified by country, with method of treatment guidance (SoC vs AdreView™ group) as the only covariate.||3.719|0.295|0.8459
72476865|NCT01139580|144479600|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel|||||||<0.001
72476866|NCT01139580|144479603|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||Cochran-Mantel-Haenszel|||||||0.001
72476867|NCT00633880|144479606|SUPERIORITY_OR_OTHER|||||||0.509||||||Statistical analysis plan involved a hierarchical assessment of secondary endpoints to prevent inflation of type I errors. As the primary endpoint was not positive, statistical analysis was not performed on secondary endpoints.|Wilcoxon (Mann-Whitney)|||||||0.509
72476868|NCT00633880|144479611|SUPERIORITY_OR_OTHER|||||||0.026|||||||Wilcoxon (Mann-Whitney)|||||||0.026
72476869|NCT00515853|144479634|SUPERIORITY|||||||0.54|||||||Regression, Linear|||CCI final||||0.54
72399533|NCT02981342|144306003|SUPERIORITY||LSMean Difference|-1.45|STANDARD_ERROR_OF_MEAN|8.54||0.866|TWO_SIDED|95.0|-18.66|15.77|||Mixed Models Analysis|||Symptom Scales: Nausea and Vomiting||15.77|-18.66|0.866
72508502|NCT01070550|144548030|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.638||||0.0255|TWO_SIDED|95.0|0.431|0.946|||Regression, Logistic|||The statistical analysis is presented for sex (male vs female). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.946|0.431|0.0255
72508503|NCT01070550|144548030|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.755||||0.0059|TWO_SIDED|95.0|0.618|0.922|||Regression, Logistic|||The statistical analysis is presented for HCV RNA at BL in log10(IU/mL). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.922|0.618|0.0059
72476870|NCT00589121|144479637|SUPERIORITY_OR_OTHER|The fixed rate of 37% comes from the published National Cancer Institute of Canada trial SR2 (CAN-NCIC-SR2: Phase III Randomized Study of Pre- vs Postoperative Radiotherapy in Curable Extremity Soft Tissue Sarcoma) receiving preoperative radiation therapy without image-guided radiation therapy (IGRT).||||||0.0005|||||||Fisher Exact|||Initially designed to test for a 20% absolute improvement from 37% (fixed rate) to 17% using Fisher's exact test, requiring 41 patients per cohort (51 with 20% ineligibility) with 5% type I error and 90% statistical power. During accrual, the sample size for cohort B was increased to 66 (83 with 20% ineligibility) to test for a 15% improvement with 5% type I error and 85% power.||||0.0005
72476871|NCT03748992|144479653|OTHER|Since no hypothesis testing was planned, no power analysis was required||||||||||||Non Applicable||Non Applicable||This was a single arm trial. there is no comparator group.|The overall response rates were calculated, and exact binomial confidence intervals was constructed.|||
72476872|NCT03748992|144479655|OTHER|Since no hypothesis testing was planned, no power analysis was required||||||||||||||||This was a single arm trial. there is no comparator group.|The overall response rates were calculated, and exact binomial confidence intervals was constructed.|||
72476873|NCT03924765|144479670|OTHER|A one-way repeated measures analysis of variance (ANOVA) was performed on different exoskeleton assistance strategies (including the baseline of not wearing the exoskeleton) on the subject's overground self-selected walking speed by setting an alpha value to 0.05.||||||5e-06|||||||ANOVA|||Primary Outcome Measure - Arm/Group 1||||0.000005
72476874|NCT03924765|144479671|OTHER|A one-way repeated measures analysis of variance (ANOVA) was performed on different exoskeleton assistance strategies (including the baseline of not wearing the exoskeleton) on the subject's step length asymmetry by setting an alpha value to 0.05.||||||0.131|||||||ANOVA|||Secondary Outcome Measure - Arm/Group 1||||0.131
72476875|NCT04548544|144479680|OTHER|||||||0.38|||||||ANOVA|||timepoint × group interaction|timepoint × group interaction F = 0.77, p = 0.38|||0.38
72476876|NCT01370590|144479699|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Ezetimibe/atorvastatin 10 mg/20 mg combination tablet was considered equivalent to co-administration of ezetimibe 10 mg and atorvastatin 20 mg, if the two-sided 97.5% expanded confidence intervals of the treatment difference in least squares means for percent change in LDL-C from baseline after 6 weeks of treatment (combination minus co-administration) was contained within -4% and 4% (equivalence margins).|Difference in Least-square Means|-0.2|||||TWO_SIDED|97.5|-1.7|3.3|||ANCOVA|||It was anticipated that 85% of the enrolled participants would be evaluable to achieve 95% power in order to establish equivalence between the Ezetimibe/Atorvastatin Fixed Dose Combination and the co-administration of Ezetimibe and Atorvastatin with respect to percent change from baseline in LDL-C after 6 weeks of treatment using two one-sided tests each at 2.5% α-level, assuming the underlying true treatment difference is ±1.4% and that the standard deviation of the difference is 12.8%.||3.3|-1.7|
72476877|NCT01370590|144479700|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least-square means|0.3|||||TWO_SIDED|97.5|-0.8|1.4|||ANCOVA|||||1.4|-0.8|
72476878|NCT01370590|144479701|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least-squares mean|0.8|||||TWO_SIDED|97.5|-0.6|2.2|||ANCOVA|||||2.2|-0.6|
72476879|NCT01370590|144479702|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-squares means|0.0|||||TWO_SIDED|97.5|-1.3|1.4|||ANCOVA|||||1.4|-1.3|
72399534|NCT02981342|144306003|SUPERIORITY||LSMean Difference|-3.9|STANDARD_ERROR_OF_MEAN|8.59||0.652|TWO_SIDED|95.0|-21.23|13.43|||Mixed Models Analysis|||Symptom Scales: Nausea and Vomiting||13.43|-21.23|0.652
72566340|NCT02697773|144663265|SUPERIORITY||Odds Ratio (OR)|2.06||||0.0172|TWO_SIDED|95.0|1.14|3.72|||Regression, Logistic|||Week 4, \>=90%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.72|1.14|0.0172
72399535|NCT02981342|144306003|SUPERIORITY||LSMean Difference|7.11|STANDARD_ERROR_OF_MEAN|8.67||0.417|TWO_SIDED|95.0|-10.39|24.6|||Mixed Models Analysis|||Symptom Scales: Pain||24.60|-10.39|0.417
72399536|NCT02981342|144306003|SUPERIORITY||LSMean Difference|4.36|STANDARD_ERROR_OF_MEAN|8.69||0.618|TWO_SIDED|95.0|-13.16|21.89|||Mixed Models Analysis|||Symptom Scales: Pain||21.89|-13.16|0.618
72399537|NCT02981342|144306003|SUPERIORITY||LSMean Difference|-10.84|STANDARD_ERROR_OF_MEAN|8.44||0.206|TWO_SIDED|95.0|-27.85|6.18|||Mixed Models Analysis|||Symptom Scales: Dyspnoea||6.18|-27.85|0.206
72399538|NCT02981342|144306003|SUPERIORITY||LSMean Difference|4.86|STANDARD_ERROR_OF_MEAN|8.4||0.566|TWO_SIDED|95.0|-12.08|21.8|||Mixed Models Analysis|||Symptom Scales: Dyspnoea||21.80|-12.08|0.566
72476880|NCT01370590|144479703|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-squares means|0.7|||||TWO_SIDED|97.5|-0.6|1.9|||ANCOVA|||||1.9|-0.6|
72476881|NCT01370590|144479704|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-squares means|1.6|||||TWO_SIDED|97.5|-3.2|6.3|||Constrained Longitudinal Data Analysis|||Analyses were based on log-transformed data.||6.3|-3.2|
72476882|NCT05172050|144479705|SUPERIORITY|Analysis is based on Exact Binary logistic regression model with treatment group, age group and status as main effects.|Odds Ratio (OR)|9.99||||0.0109|TWO_SIDED|95.0|1.781||Upper limit is not estimable (NE) due to the low number of events||Regression, Logistic||||||1.781|0.0109
72476883|NCT05172050|144479705|SUPERIORITY|Analysis is based on Exact Binary logistic regression model with treatment group, age group and status as main effects.|Odds Ratio (OR)|5.414||||0.0673|TWO_SIDED|95.0|0.858||The upper limit is not estimable (NE), due to the low number of events||Regression, Logistic||||||0.858|0.0673
72476884|NCT05172050|144479705|SUPERIORITY||Odds Ratio (OR)|12.186||||0.0061|TWO_SIDED|95.0|2.147||The upper limit was not estimable due to the low number of events|Analysis is based on Exact Binary logistic regression model with treatment group, age group and status as main effects.|Regression, Logistic|||This sensitivity analysis is conducted on the per protocol (PP) population: n=18 in the Raloxifene 60 mg arm; n=17 in the Raloxifene 120 mg arm; and n=17 in the Placebo arm.|||2.147|0.0061
72476885|NCT05172050|144479705|SUPERIORITY||Odds Ratio (OR)|5.936||||0.0567|TWO_SIDED|95.0|0.938||The upper limit was not estimable due to the low number of events|Analysis is based on Exact Binary logistic regression model with treatment group, age group and status as main effects.|Regression, Logistic|||This sensitivity analysis is conducted on the per protocol (PP) population: n=18 in the Raloxifene 60 mg arm; n=17 in the Raloxifene 120 mg arm; and n=17 in the Placebo arm|||0.938|0.0567
72476886|NCT05172050|144479706|SUPERIORITY|Analysis is based on Exact Binary logistic regression model with treatment group, age group and status as main effects|Odds Ratio (OR)|1.663||||0.7121|TWO_SIDED|95.0|0.337|9.053|||Regression, Logistic|||||9.053|0.337|0.7121
72566341|NCT02697773|144663265|SUPERIORITY||Odds Ratio (OR)|2.06||||0.0173|TWO_SIDED|95.0|1.14|3.72|||Regression, Logistic|||Week 4, \>=90%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.72|1.14|0.0173
72566342|NCT02697773|144663265|SUPERIORITY||Odds Ratio (OR)|1.62||||0.0118|TWO_SIDED|95.0|1.11|2.35|||Regression, Logistic|||Week 8, \>=30%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.35|1.11|0.0118
72399539|NCT02981342|144306003|SUPERIORITY||LSMean Difference|-7.02|STANDARD_ERROR_OF_MEAN|7.93||0.38|TWO_SIDED|95.0|-23.01|8.96|||Mixed Models Analysis|||Symptom Scales: Insomnia||8.96|-23.01|0.380
72566343|NCT02697773|144663265|SUPERIORITY||Odds Ratio (OR)|1.6||||0.0132|TWO_SIDED|95.0|1.1|2.32|||Regression, Logistic|||Week 8, \>=30%:Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.32|1.10|0.0132
72566344|NCT02697773|144663265|SUPERIORITY||Odds Ratio (OR)|1.99||||0.0005|TWO_SIDED|95.0|1.35|2.92|||Regression, Logistic|||Week 8, \>=50%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.92|1.35|0.0005
72566345|NCT02697773|144663265|SUPERIORITY||Odds Ratio (OR)|1.66||||0.01|TWO_SIDED|95.0|1.13|2.45|||Regression, Logistic|||Week 8, \>=50%:Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.45|1.13|0.0100
72566346|NCT02697773|144663265|SUPERIORITY||Odds Ratio (OR)|2.0||||0.0023|TWO_SIDED|95.0|1.28|3.12|||Regression, Logistic|||Week 8, \>=70%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.12|1.28|0.0023
72566347|NCT02697773|144663265|SUPERIORITY||Odds Ratio (OR)|1.64||||0.0322|TWO_SIDED|95.0|1.04|2.58|||Regression, Logistic|||Week 8, \>=70%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.58|1.04|0.0322
72566348|NCT02697773|144663265|SUPERIORITY||Odds Ratio (OR)|1.48||||0.2005|TWO_SIDED|95.0|0.81|2.67|||Regression, Logistic|||Week 8, \>=90%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.67|0.81|0.2005
72566349|NCT02697773|144663265|SUPERIORITY||Odds Ratio (OR)|1.48||||0.1923|TWO_SIDED|95.0|0.82|2.68|||Regression, Logistic|||Week 8, \>=90%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.68|0.82|0.1923
72566350|NCT02697773|144663265|SUPERIORITY||Odds Ratio (OR)|1.89||||0.0013|TWO_SIDED|95.0|1.28|2.79|||Regression, Logistic|||Week 12, \>=30%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.79|1.28|0.0013
72566351|NCT02697773|144663265|SUPERIORITY||Odds Ratio (OR)|2.5|||<|0.0001|TWO_SIDED|95.0|1.68|3.73|||Regression, Logistic|||Week 12, \>=30%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.73|1.68|<.0001
72566352|NCT02697773|144663265|SUPERIORITY||Odds Ratio (OR)|2.12|||<|0.0001|TWO_SIDED|95.0|1.45|3.1|||Regression, Logistic|||Week 12, \>=50%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.10|1.45|<.0001
72566353|NCT02697773|144663265|SUPERIORITY||Odds Ratio (OR)|1.84||||0.0014|TWO_SIDED|95.0|1.26|2.67|||Regression, Logistic|||Week 12, \>=50%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.67|1.26|0.0014
72566354|NCT02697773|144663265|SUPERIORITY||Odds Ratio (OR)|2.0||||0.0008|TWO_SIDED|95.0|1.33|2.99|||Regression, Logistic|||Week 12, \>=70%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.99|1.33|0.0008
72566355|NCT02697773|144663265|SUPERIORITY||Odds Ratio (OR)|2.05||||0.0005|TWO_SIDED|95.0|1.37|3.06|||Regression, Logistic|||Week 12, \>=70%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.06|1.37|0.0005
72566356|NCT02697773|144663265|SUPERIORITY||Odds Ratio (OR)|2.01||||0.0127|TWO_SIDED|95.0|1.16|3.49|||Regression, Logistic|||Week 12, \>=90%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.49|1.16|0.0127
72566357|NCT02697773|144663265|SUPERIORITY||Odds Ratio (OR)|2.11||||0.0075|TWO_SIDED|95.0|1.22|3.64|||Regression, Logistic|||Week 12, \>=90%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.64|1.22|0.0075
72399540|NCT02981342|144306003|SUPERIORITY||LSMean Difference|1.52|STANDARD_ERROR_OF_MEAN|7.99||0.85|TWO_SIDED|95.0|-14.6|17.64|||Mixed Models Analysis|||Symptom Scales: Insomnia||17.64|-14.60|0.850
72508504|NCT01070550|144548030|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.521||||0.0005|TWO_SIDED|95.0|1.501|4.236|||Regression, Logistic|||The statistical analysis is presented for liver fibrosis (no cirrhosis vs cirrhosis). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||4.236|1.501|0.0005
72399541|NCT02981342|144306003|SUPERIORITY||LSMean Difference|-2.79|STANDARD_ERROR_OF_MEAN|8.91||0.756|TWO_SIDED|95.0|-20.78|15.21|||Mixed Models Analysis|||Symptom Scales: Appetite loss||15.21|-20.78|0.756
72508505|NCT01070550|144548030|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.602||||0.0011|TWO_SIDED|95.0|1.463|4.627|||Regression, Logistic|||The statistical analysis is presented for liver fibrosis (not assessed/missed vs cirrhosis). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||4.627|1.463|0.0011
72399542|NCT02981342|144306003|SUPERIORITY||LSMean Difference|3.02|STANDARD_ERROR_OF_MEAN|9.31||0.747|TWO_SIDED|95.0|-15.77|21.82|||Mixed Models Analysis|||Symptom Scales: Appetite loss||21.82|-15.77|0.747
72508506|NCT01070550|144548030|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.727||||0.0034|TWO_SIDED|95.0|1.198|2.491|||Regression, Logistic|||The statistical analysis is presented for mode of infection (other vs injection drug U). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||2.491|1.198|0.0034
72508507|NCT01070550|144548030|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.545||||0.0014|TWO_SIDED|95.0|0.376|0.792|||Regression, Logistic|||The statistical analysis is presented for AST ratio at BL (\> 1.5 vs \<=1.5). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.792|0.376|0.0014
72508508|NCT01070550|144548030|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.047|||<|0.0001|TWO_SIDED|95.0|1.029|1.065|||Regression, Logistic|||The statistical analysis is presented for treatment duration after VR in weeks. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.065|1.029|<0.0001
72566358|NCT02697773|144663265|SUPERIORITY||Odds Ratio (OR)|1.72||||0.0061|TWO_SIDED|95.0|1.17|2.52|||Regression, Logistic|||Week 16 \>=30%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.52|1.17|0.0061
72566359|NCT02697773|144663265|SUPERIORITY||Odds Ratio (OR)|1.95||||0.0007|TWO_SIDED|95.0|1.33|2.88|||Regression, Logistic|||Week 16 \>=30%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.88|1.33|0.0007
72566360|NCT02697773|144663265|SUPERIORITY|The two comparisons for 'Participants with \>=50% reduction from baseline in WOMAC Pain at Week 16' (tanezumab 2.5 mg treatment group versus placebo and tanezumab 2.5/5 mg treatment group versus placebo) were adjusted for multiple comparisons using the Hochberg procedure and an overall significance level of 0.05.|Odds Ratio (OR)|1.89||||0.001|TWO_SIDED|95.0|1.29|2.76|||Regression, Logistic|||Week 16 \>=50%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.76|1.29|0.0010
72399543|NCT02981342|144306003|SUPERIORITY||LSMean Difference|9.47|STANDARD_ERROR_OF_MEAN|9.23||0.311|TWO_SIDED|95.0|-9.16|28.09|||Mixed Models Analysis|||Symptom Scales: Constipation||28.09|-9.16|0.311
72399544|NCT02981342|144306003|SUPERIORITY||LSMean Difference|-9.97|STANDARD_ERROR_OF_MEAN|9.3||0.29|TWO_SIDED|95.0|-28.75|8.8|||Mixed Models Analysis|||Symptom Scales: Constipation||8.80|-28.75|0.290
72399545|NCT02981342|144306003|SUPERIORITY||LSMean Difference|-10.57|STANDARD_ERROR_OF_MEAN|10.58||0.323|TWO_SIDED|95.0|-31.93|10.78|||Mixed Models Analysis|||Symptom Scales: Diarrhoea||10.78|-31.93|0.323
72399546|NCT02981342|144306003|SUPERIORITY||LSMean Difference|-4.8|STANDARD_ERROR_OF_MEAN|10.54||0.651|TWO_SIDED|95.0|-26.08|16.48|||Mixed Models Analysis|||Symptom Scales: Diarrhoea||16.48|-26.08|0.651
72399547|NCT02981342|144306003|SUPERIORITY||LSMean Difference|1.51|STANDARD_ERROR_OF_MEAN|7.47||0.841|TWO_SIDED|95.0|-13.57|16.59|||Mixed Models Analysis|||Symptom Scales: Financial Difficulties||16.59|-13.57|0.841
72508509|NCT01070550|144548030|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.896||||0.0074|TWO_SIDED|95.0|0.827|0.971|||Regression, Logistic|||The statistical analysis is presented for age per 10 years. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.971|0.827|0.0074
72508510|NCT01070550|144548030|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.971||||0.0088|TWO_SIDED|95.0|0.95|0.993|||Regression, Logistic|||The statistical analysis is presented for BMI in kg/m\^2. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.993|0.950|0.0088
72508511|NCT01070550|144548030|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.719|||<|0.0001|TWO_SIDED|95.0|0.643|0.803|||Regression, Logistic|||The statistical analysis is presented for HCV RNA at BL in log10(IU/mL). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.803|0.643|<0.0001
72399548|NCT02981342|144306003|SUPERIORITY||LSMean Difference|7.26|STANDARD_ERROR_OF_MEAN|7.57||0.344|TWO_SIDED|95.0|-8.03|22.54|||Mixed Models Analysis|||Symptom Scales: Financial Difficulties||22.54|-8.03|0.344
72476887|NCT05172050|144479706|SUPERIORITY|Analysis is based on Exact Binary logistic regression model with treatment group, age group and status as main effects|Odds Ratio (OR)|0.963|||>|0.999|TWO_SIDED|95.0|0.185|4.977|||Regression, Logistic|||||4.977|0.185|>0.999
72508512|NCT01070550|144548030|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.683|||<|0.0001|TWO_SIDED|95.0|1.346|2.106|||Regression, Logistic|||The statistical analysis is presented for liver fibrosis (no cirrhosis vs cirrhosis). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||2.106|1.346|<0.0001
72508513|NCT01070550|144548030|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.11||||0.4479|TWO_SIDED|95.0|0.848|1.453|||Regression, Logistic|||The statistical analysis is presented for liver fibrosis (not assessed/missing vs cirrhosis). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.453|0.848|0.4479
72508514|NCT01070550|144548030|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.64||||0.0123|TWO_SIDED|95.0|0.451|0.908|||Regression, Logistic|||The statistical analysis is presented for ALT ratio at BL (\<=1 vs \> 3). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.908|0.451|0.0123
72508515|NCT01070550|144548030|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.72||||0.0147|TWO_SIDED|95.0|0.553|0.937|||Regression, Logistic|||The statistical analysis is presented for ALT ratio at BL (\> 1 - 3 vs \> 3). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.937|0.553|0.0147
72476888|NCT05172050|144479706|SUPERIORITY||Odds Ratio (OR)|2.34||||0.5378|TWO_SIDED|95.0|0.35|20.153||Analysis is based on Exact Binary logistic regression model with treatment group, age group and status as main effects.|Regression, Logistic|||This sensitivity analysis is conducted on the per protocol (PP) population: n=18 in the Raloxifene 60 mg arm; n=17 in the Raloxifene 120 mg arm; and n=17 in the Placebo arm||20.153|0.350|0.5378
72476889|NCT05172050|144479706|SUPERIORITY||Odds Ratio (OR)|1.209|||>|0.999|TWO_SIDED|95.0|0.185|8.589||Analysis is based on Exact Binary logistic regression model with treatment group, age group and status as main effects.|Regression, Logistic|||This sensitivity analysis is conducted on the per protocol (PP) population: n=18 in the Raloxifene 60 mg arm; n=17 in the Raloxifene 120 mg arm; and n=17 in the Placebo arm||8.589|0.185|>0.999
72508516|NCT01070550|144548030|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.718||||0.0071|TWO_SIDED|95.0|0.564|0.914|||Regression, Logistic|||The statistical analysis is presented for AST ratio at BL (\> 1.5 vs \<=1.5). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.914|0.564|0.0071
72508517|NCT01070550|144548030|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.058|||<|0.0001|TWO_SIDED|95.0|1.052|1.064|||Regression, Logistic|||The statistical analysis is presented for treatment duration after VR in weeks. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.064|1.052|<0.0001
72508518|NCT01070550|144548030|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.014||||0.0019|TWO_SIDED|95.0|1.005|1.023|||Regression, Logistic|||The statistical analysis is presented for cumulative ribavirin dose per 10000 mg. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.023|1.005|0.0019
72508519|NCT01070550|144548030|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.701||||0.0083|TWO_SIDED|95.0|0.539|0.913|||Regression, Logistic|||The statistical analysis is presented for age per 10 years. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.913|0.539|0.0083
72508520|NCT01070550|144548030|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.174|||<|0.0001|TWO_SIDED|95.0|0.09|0.338|||Regression, Logistic|||The statistical analysis is presented for sex (male vs female). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.338|0.090|<0.0001
72399549|NCT02432846|144306072|OTHER|Exploratory superiority (non-powered)|Hazard Ratio (HR)|0.978||||0.964|TWO_SIDED|95.0|0.371|2.579|||Log Rank|||||2.579|0.371|0.964
72476890|NCT05172050|144479707|SUPERIORITY||Odds Ratio (OR)|1.114|||>|0.999|TWO_SIDED|95.0|0.219|5.708|||Regression, Logistic|Analysis is based on Exact Binary logistic regression model with treatment group, age group and status as main effects.||at Day 14||5.708|0.219|>0.999
72476891|NCT05172050|144479707|SUPERIORITY||Odds Ratio (OR)|3.202||||0.2553|TWO_SIDED|95.0|0.541|22.116|||Regression, Logistic|Analysis is based on Exact Binary logistic regression model with treatment group, age group and status as main effects.||At day 14||22.116|0.541|0.2553
72476892|NCT05172050|144479707|SUPERIORITY||Odds Ratio (OR)|2.16||||0.6189|TWO_SIDED|95.0|0.294|18.532|||Regression, Logistic|Analysis is based on Exact Binary logistic regression model with treatment group, age group and status as main effects.||at Day 28||18.532|0.294|0.6189
72566361|NCT02697773|144663265|SUPERIORITY||Odds Ratio (OR)|1.53||||0.0411|TWO_SIDED|95.0|1.02|2.31|||Regression, Logistic|||Week 16, \>=70%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.31|1.02|0.0411
72399550|NCT02432846|144306072|OTHER|Exploratory superiority (non-powered)|Hazard Ratio (HR)|0.619||||0.163|TWO_SIDED|95.0|0.314|1.222|||Log Rank|||||1.222|0.314|0.163
72476893|NCT05172050|144479707|SUPERIORITY||Odds Ratio (OR)|7.22||||0.1662|TWO_SIDED|95.0|0.586|413.499|||Regression, Logistic|Analysis is based on Exact Binary logistic regression model with treatment group, age group and status as main effects.||at Day 28||413.499|0.586|0.1662
72476894|NCT05172050|144479708|SUPERIORITY||Odds Ratio (OR)|0.972|||>|0.999|TWO_SIDED|95.0|0.193|4.906|||Regression, Logistic|Analysis is based on Exact Binary logistic regression model with treatment group, age group and status as main effects||at Day 7||4.906|0.193|>0.999
72476895|NCT05172050|144479708|SUPERIORITY||Odds Ratio (OR)|1.156|||>|0.999|TWO_SIDED|95.0|0.2|6.822|||Regression, Logistic|Analysis is based on Exact Binary logistic regression model with treatment group, age group and status as main effects||at Day 7||6.822|0.200|>0.999
72476896|NCT05172050|144479708|SUPERIORITY||Odds Ratio (OR)|1.066|||>|0.999|TWO_SIDED|95.0|0.208|5.478|||Regression, Logistic|Analysis is based on Exact Binary logistic regression model with treatment group, age group and status as main effects||at Day 28||5.478|0.208|>0.999
72508521|NCT01070550|144548030|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.057||||0.0008|TWO_SIDED|95.0|1.023|1.091|||Regression, Logistic|||The statistical analysis is presented for treatment duration after VR in weeks. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.091|1.023|0.0008
72508522|NCT01070550|144548030|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.638||||0.0255|TWO_SIDED|95.0|0.431|0.946|||Regression, Logistic|||The statistical analysis is presented for sex (male vs female). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.946|0.431|0.0255
72508523|NCT01070550|144548030|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.755||||0.0059|TWO_SIDED|95.0|0.618|0.922|||Regression, Logistic|||The statistical analysis is presented for HCV RNA at BL in log10(IU/mL). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.922|0.618|0.0059
72508524|NCT01070550|144548030|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.521||||0.0005|TWO_SIDED|95.0|1.501|4.236|||Regression, Logistic|||The statistical analysis is presented for liver fibrosis (no cirrhosis vs cirrhosis). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||4.236|1.501|0.0005
72508525|NCT01070550|144548030|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.602||||0.0011|TWO_SIDED|95.0|1.463|4.627|||Regression, Logistic|||The statistical analysis is presented for liver fibrosis (not assessed/missing vs cirrhosis). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||4.627|1.463|0.0011
72399551|NCT02432846|144306072|OTHER|Exploratory superiority (non-powered)|Hazard Ratio (HR)|0.732||||0.25|TWO_SIDED|95.0|0.421|1.27|||Log Rank|||||1.270|0.421|0.250
72476897|NCT05172050|144479708|SUPERIORITY||Odds Ratio (OR)|2.068||||0.5465|TWO_SIDED|95.0|0.369|12.58|||Regression, Logistic|Analysis is based on Exact Binary logistic regression model with treatment group, age group and status as main effects||at Day 28||12.580|0.369|0.5465
72476898|NCT05172050|144479711|SUPERIORITY|||||||0.3899||||||P-Value comparing % among treatment groups Raloxifene 60mg versus Placebo using Fisher's Exact test.|Fisher Exact|||The proportion of hospitalized participants who at the beginning of the study were at domicile isolation at Day 7, Day 14 and Day 28 after randomization was analysed using comparison of proportions (i.e. comparisons of each active treatment group versus placebo at each assessment day) through Fisher's exact test and was summarized using frequency and percent by treatment and visit. Herein Day 7 R60 vs Placebo||||0.3899
72476899|NCT05172050|144479711|SUPERIORITY|||||||0.4075||||||P-Value comparing % among treatment groups Raloxifene 120 mg versus Placebo using Fisher's Exact test.|Fisher Exact|||The proportion of hospitalized participants who at the beginning of the study were at domicile isolation at Day 7, Day 14 and Day 28 after randomization was analysed using comparison of proportions (i.e. comparisons of each active treatment group versus placebo at each assessment day) through Fisher's exact test and was summarized using frequency and percent by treatment and visit. Herein Day 7 R120 vs placebo||||0.4075
72508526|NCT01070550|144548030|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.727||||0.0034|TWO_SIDED|95.0|1.198|2.491|||Regression, Logistic|||The statistical analysis is presented for mode of infection (other vs injection drug U). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||2.491|1.198|0.0034
72508527|NCT01070550|144548030|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.545||||0.0014|TWO_SIDED|95.0|0.376|0.792|||Regression, Logistic|||The statistical analysis is presented for AST ratio at BL (\> 1.5 vs \<=1.5). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.792|0.376|0.0014
72508528|NCT01070550|144548030|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.89||||0.0042|TWO_SIDED|95.0|0.822|0.964|||Regression, Logistic|||The statistical analysis is presented for age per 10 years. The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.964|0.822|0.0042
72508529|NCT01070550|144548030|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.824||||0.0363|TWO_SIDED|95.0|0.687|0.988|||Regression, Logistic|||The statistical analysis is presented for sex (male vs female). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.988|0.687|0.0363
72399552|NCT02432846|144306073|OTHER|Exploratory superiority (non-powered)|Hazard Ratio (HR)|0.756||||0.596|TWO_SIDED|95.0|0.268|2.134|||Log Rank|||||2.134|0.268|0.596
72399553|NCT02432846|144306073|OTHER|Exploratory superiority (non-powered)|Hazard Ratio (HR)|0.661||||0.285|TWO_SIDED|95.0|0.308|1.418|||Log Rank|||||1.418|0.308|0.285
72399554|NCT02432846|144306073|OTHER|Exploratory superiority (non-powered)|Hazard Ratio (HR)|0.699||||0.24|TWO_SIDED|95.0|0.378|1.29|||Log Rank|||||1.290|0.378|0.240
72399555|NCT02432846|144306074|OTHER|Exploratory superiority (non-powered)|||||=|0.812|||||||Log Rank|||||||= 0.812
72399556|NCT02432846|144306075|OTHER|Exploratory superiority (non-powered)|||||=|0.861|||||||Log Rank|||||||= 0.861
72399557|NCT01770379|144306087|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.55||||0.2001|TWO_SIDED|95.0|0.79|3.03|||Regression, Logistic|||||3.03|0.79|0.2001
72399558|NCT01770379|144306087|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.62||||0.1574|TWO_SIDED|95.0|0.83|3.15|||Regression, Logistic|||||3.15|0.83|0.1574
72399559|NCT03045887|144306111|OTHER||Ratio|0.41|STANDARD_ERROR_OF_MEAN|0.243|||TWO_SIDED|90.0|0.27|0.61|||||AUC(0-t). Standard error of mean was on logged scale|||0.61|0.27|
72399560|NCT03045887|144306111|OTHER||Ratio|0.98|STANDARD_ERROR_OF_MEAN|0.243|||TWO_SIDED|90.0|0.65|1.47|||||AUC(0-t).Standard error of mean was on logged scale|||1.47|0.65|
72399561|NCT03045887|144306111|OTHER||Ratio|1.33|STANDARD_ERROR_OF_MEAN|0.161|||TWO_SIDED|90.0|1.01|1.74|||||AUC(0-t).Standard error of mean was on logged scale|||1.74|1.01|
72399562|NCT03045887|144306111|OTHER||Ratio|1.06|STANDARD_ERROR_OF_MEAN|0.255|||TWO_SIDED|90.0|0.69|1.62|||||AUC(0-t).Standard error of mean was on logged scale|||1.62|0.69|
72399563|NCT03045887|144306111|OTHER||Ratio|1.25|STANDARD_ERROR_OF_MEAN|0.161|||TWO_SIDED|90.0|0.95|1.64|||||AUC(0-t).Standard error of mean was on logged scale|||1.64|0.95|
72399564|NCT03045887|144306112|OTHER||Ratio|1.22|STANDARD_ERROR_OF_MEAN|0.098|||TWO_SIDED|90.0|1.01|1.47|||||Treatment ratio of adjusted geometric mean (Day 14/Day 1) for AUC(0-24) is presented|||1.47|1.01|
72399565|NCT03045887|144306113|OTHER||ratio|0.78|STANDARD_ERROR_OF_MEAN|0.145|||TWO_SIDED|90.0|0.61|0.99||||||||0.99|0.61|
72399566|NCT03045887|144306113|OTHER||ratio|0.96|STANDARD_ERROR_OF_MEAN|0.145|||TWO_SIDED|90.0|0.75|1.22||||||||1.22|0.75|
72399567|NCT03045887|144306113|OTHER||ratio|0.81|STANDARD_ERROR_OF_MEAN|0.106|||TWO_SIDED|90.0|0.68|0.97||||||||0.97|0.68|
72476900|NCT05172050|144479711|SUPERIORITY|||||||0.3899||||||P-Value comparing % among treatment groups Raloxifene 60mg versus Placebo using Fisher's Exact test.|Fisher Exact|||The proportion of hospitalized participants who at the beginning of the study were at domicile isolation at Day 7, Day 14 and Day 28 after randomization was analysed using comparison of proportions (i.e. comparisons of each active treatment group versus placebo at each assessment day) through Fisher's exact test and was summarized using frequency and percent by treatment and visit. Herein Day 14 R60 vs placebo||||0.3899
72399568|NCT03045887|144306113|OTHER||ratio|0.66|STANDARD_ERROR_OF_MEAN|0.154|||TWO_SIDED|90.0|0.51|0.86||||||||0.86|0.51|
72399569|NCT03045887|144306113|OTHER||ratio|0.76|STANDARD_ERROR_OF_MEAN|0.106|||TWO_SIDED|90.0|0.63|0.9||||||||0.90|0.63|
72399570|NCT03045887|144306114|OTHER||ratio|1.14|STANDARD_ERROR_OF_MEAN|0.104|||TWO_SIDED|90.0|0.96|1.36|||||Treatment ratio of adjusted geometric mean (Day 14/Day 1) for Cmax is presented|||1.36|0.96|
72399571|NCT03045887|144306120|OTHER||Ratio|2.06|STANDARD_ERROR_OF_MEAN|0.128|||TWO_SIDED|90.0|1.67|2.55|||||Treatment ratio of adjusted geometric mean (Day 14/Day 1) for Ctau is presented.|||2.55|1.67|
72399572|NCT01912287|144306125|SUPERIORITY||Odds Ratio (OR)|2.46||||0.03|TWO_SIDED|95.0|1.12|5.42|||Generalized Linear Mixed Models|||This comparison is from the Generalized Linear Mixed Models (GLMM) analysis using a quadratic growth curve over time. This comparison is at post-treatment. Note, although all 3 groups are included in the GLMM, this statistical test specifically compares response rates of KY vs. SE at post-treatment||5.42|1.12|.03
72399573|NCT01912287|144306125|SUPERIORITY||Odds Ratio, log|5.0|||<|0.001|TWO_SIDED|95.0|2.12|11.82|||Generalized Linear Mixed Models|||This comparison is from the Generalized Linear Mixed Models (GLMM) analysis using a quadratic growth curve over time. This comparison is at post-treatment. Note, although all 3 groups are included in the GLMM, this statistical test specifically compares response rates of CBT vs. SE at post-treatment||11.82|2.12|<.001
72399574|NCT01912287|144306125|SUPERIORITY||Odds Ratio (OR)|0.49||||0.07|TWO_SIDED|95.0|0.24|1.03|||Generalized Linear Mixed Models|||This comparison is from the Generalized Linear Mixed Models (GLMM) analysis using a quadratic growth curve over time. This comparison is at post-treatment. Note, although all 3 groups are included in the GLMM, this statistical test specifically compares response rates of KY vs. CBT at post-treatment||1.03|0.24|0.07
72399575|NCT03914326|144306130|SUPERIORITY|Time from randomisation to first EAC-confirmed MACE was analysed using a Cox proportional hazards model with treatment as categorical fixed factor.|Hazard Ratio (HR)|0.86||||0.0028|TWO_SIDED|95.0|0.77|0.96|||Regression, Cox|||||0.96|0.77|0.0028
72399576|NCT03226392|144306158|SUPERIORITY||Mean Difference (Net)|-0.031||||0.214|TWO_SIDED|95.0|-0.08|0.018|||ANCOVA|||||0.018|-0.080|0.214
72399577|NCT03226392|144306159|SUPERIORITY||Mean Difference (Net)|-0.1||||0.035|TWO_SIDED|0.035|-0.19|0.01|||ANCOVA|||||0.01|-0.19|0.035
72399578|NCT03226392|144306160|SUPERIORITY||Mean Difference (Net)|0.093||||0.893|TWO_SIDED|95.0|-0.2|0.17|||ANCOVA|||||0.17|-0.20|0.893
72399579|NCT03226392|144306161|SUPERIORITY||Mean Difference (Net)|0.061||||0.448|TWO_SIDED|95.0|-0.07|0.17|||ANCOVA|||||0.17|-0.07|0.448
72399580|NCT02357901|144306162|SUPERIORITY||||||<|0.0001||||||significance at the 0.025 level|Wilcoxon rank-sum test|||||||<0.0001
72399581|NCT02357901|144306162|SUPERIORITY||||||<|0.0001||||||significance at the 0.025 level|Wilcoxon rank-sum test|||||||<0.0001
72399582|NCT02357901|144306163|SUPERIORITY||||||<|0.0001||||||Significance level of 0.05.|Cochran-Mantel-Haenszel|||||||<0.0001
72399583|NCT02357901|144306163|SUPERIORITY||||||<|0.0001||||||Significance level of 0.05.|Cochran-Mantel-Haenszel|||||||<0.0001
72399584|NCT02357901|144306164|SUPERIORITY||||||<|0.0001||||||Significance level of 0.05.|Wilcoxon rank-sum test|||||||<0.0001
72399585|NCT02357901|144306164|SUPERIORITY||||||<|0.0001||||||Significance level of 0.05.|Wilcoxon rank-sum test|||||||<0.0001
72399586|NCT02357901|144306165|SUPERIORITY||||||<|0.0001||||||Significance level of 0.05.|Wilcoxon rank-sum test|||||||<0.0001
72399587|NCT02357901|144306165|SUPERIORITY||||||<|0.0001||||||Significance level of 0.05.|Wilcoxon rank-sum test|||||||<0.0001
72566362|NCT02697773|144663265|SUPERIORITY||Odds Ratio (OR)|1.72||||0.009|TWO_SIDED|95.0|1.14|2.57|||Regression, Logistic|||Week 16, \>=70%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.57|1.14|0.0090
72476901|NCT05172050|144479711|SUPERIORITY|||||||0.4075|||||||Fisher Exact|P-Value comparing % among treatment groups Raloxifene 120mg versus Placebo using Fisher's Exact test.||The proportion of hospitalized participants who at the beginning of the study were at domicile isolation at Day 7, Day 14 and Day 28 after randomization was analysed using comparison of proportions (i.e. comparisons of each active treatment group versus placebo at each assessment day) through Fisher's exact test and was summarized using frequency and percent by treatment and visit. Herein Day 14 R120 vs placebo||||0.4075
72476902|NCT05172050|144479711|SUPERIORITY|||||||0.6846||||||P-Value comparing % among treatment groups Raloxifene 60mg versus Placebo using Fisher's Exact test.|Fisher Exact|||The proportion of hospitalized participants who at the beginning of the study were at domicile isolation at Day 7, Day 14 and Day 28 after randomization was analysed using comparison of proportions (i.e. comparisons of each active treatment group versus placebo at each assessment day) through Fisher's exact test and was summarized using frequency and percent by treatment and visit. Herein Day 28 R60 vs placebo||||0.6846
72476903|NCT05172050|144479711|SUPERIORITY|||||||0.6614||||||P-Value comparing % among treatment groups Raloxifene 120mg versus Placebo using Fisher's Exact test.|Fisher Exact|||The proportion of hospitalized participants who at the beginning of the study were at domicile isolation at Day 7, Day 14 and Day 28 after randomization was analysed using comparison of proportions (i.e. comparisons of each active treatment group versus placebo at each assessment day) through Fisher's exact test and was summarized using frequency and percent by treatment and visit. Herein Day 28 R120 vs placebo||||0.6614
72476904|NCT05172050|144479713|SUPERIORITY||Hazard Ratio (HR)|1.0|||||TWO_SIDED|95.0|1.0|1.0|||Log Rank|||||1.00|1.00|
72476905|NCT05172050|144479713|SUPERIORITY||Hazard Ratio (HR)|1.0|||||TWO_SIDED|95.0|1.0|1.0||p value= not estimable|Log Rank|||||1.00|1.00|
72476906|NCT00604825|144479726|SUPERIORITY||Adjusted Mean Difference|0.75||||0.215|TWO_SIDED|95.0|-0.44|1.93||Analysis included the terms for: Treatment + Baseline + country + uterine strata.|General linear model|||Placebo vs. GSK232802 25 mg||1.93|-0.44|0.215
72476907|NCT00604825|144479726|SUPERIORITY||Adjusted Mean Difference|1.21||||0.041|TWO_SIDED|95.0|0.05|2.37||Analysis included the terms for: Treatment + Baseline + country + uterine strata.|General linear model|||Placebo vs. GSK232802 75 mg||2.37|0.05|0.041
72476908|NCT00604825|144479726|SUPERIORITY||Adjusted Mean Difference|-2.06|||<|0.001|TWO_SIDED|95.0|-3.2|-0.92||Analysis included the terms for: Treatment + Baseline + country + uterine strata.|General linear model|||Placebo vs. Premarin 0.3 mg||-0.92|-3.20|<0.001
72476909|NCT00604825|144479727|SUPERIORITY||Adjusted Mean Difference|0.15||||0.202|TWO_SIDED|95.0|-0.08|0.38||Analysis included the terms for: Treatment + Baseline + country + uterine strata.|General linear model|||Placebo vs. GSK232802 25 mg||0.38|-0.08|0.202
72476910|NCT00604825|144479727|SUPERIORITY||Adjusted Mean Difference|0.31||||0.008|TWO_SIDED|95.0|0.08|0.54||Analysis included the terms for: Treatment + Baseline + country + uterine strata.|General linear model|||Placebo vs. GSK232802 75 mg||0.54|0.08|0.008
72476911|NCT00604825|144479727|SUPERIORITY||Adjusted Mean Difference|-0.52|||<|0.001|TWO_SIDED|95.0|-0.75|-0.3||Analysis included the terms for: Treatment + Baseline + country + uterine strata.|General linear model|||Placebo vs. Premarin 0.3 mg||-0.30|-0.75|<0.001
72476912|NCT04617275|144479770|SUPERIORITY||Mean Difference (Final Values)|2.31||||0.5863|TWO_SIDED|90.0|-15.23|19.85||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||19.85|-15.23|0.5863
72476913|NCT04617275|144479770|SUPERIORITY||Mean Difference (Final Values)|-17.41||||0.0494|TWO_SIDED|90.0|-34.75|-0.06||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-0.06|-34.75|0.0494
72476914|NCT04617275|144479770|SUPERIORITY||Mean Difference (Final Values)|-30.85||||0.0019|TWO_SIDED|90.0|-48.09|-13.61||1-Sided|Mixed Models Analysis|MMRM|Test = PF06882961 Reference = Placebo|||-13.61|-48.09|0.0019
72566363|NCT02697773|144663265|SUPERIORITY||Odds Ratio (OR)|1.6||||0.1149|TWO_SIDED|95.0|0.89|2.86|||Regression, Logistic|||Week 16, \>=90%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.86|0.89|0.1149
72476915|NCT04617275|144479770|SUPERIORITY||Mean Difference (Final Values)|-33.66||||0.0009|TWO_SIDED|90.0|-51.0|-16.32||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-16.32|-51.00|0.0009
72476916|NCT04617275|144479770|SUPERIORITY||Mean Difference (Final Values)|-19.52||||0.0343|TWO_SIDED|90.0|-37.12|-1.92||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-1.92|-37.12|0.0343
72476917|NCT04617275|144479771|SUPERIORITY||Mean Difference (Final Values)|-3.33||||0.3804|TWO_SIDED|90.0|-21.41|14.76||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||14.76|-21.41|0.3804
72476918|NCT04617275|144479771|SUPERIORITY||Mean Difference (Final Values)|-19.65||||0.0348|TWO_SIDED|90.0|-37.44|-1.87||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-1.87|-37.44|0.0348
72476919|NCT04617275|144479771|SUPERIORITY||Mean Difference (Final Values)|-32.8||||0.0014|TWO_SIDED|90.0|-50.54|-15.05||1-Sided|Mixed Models Analysis|MMRM|Test = PF06882961 Reference = Placebo|||-15.05|-50.54|0.0014
72476920|NCT04617275|144479771|SUPERIORITY||Mean Difference (Final Values)|-35.85||||0.0007|TWO_SIDED|90.0|-53.9|-17.81||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-17.81|-53.90|0.0007
72476921|NCT04617275|144479771|SUPERIORITY||Mean Difference (Final Values)|-28.49||||0.0052|TWO_SIDED|90.0|-46.6|-10.37||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-10.37|-46.60|0.0052
72476922|NCT04617275|144479772|SUPERIORITY||Mean Difference (Final Values)|-25.58||||0.025|TWO_SIDED|90.0|-46.97|-4.18||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-4.18|-46.97|0.0250
72476923|NCT04617275|144479772|SUPERIORITY||Mean Difference (Final Values)|-32.95||||0.0053|TWO_SIDED|90.0|-53.95|-11.95||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-11.95|-53.95|0.0053
72476924|NCT04617275|144479772|SUPERIORITY||Mean Difference (Final Values)|-40.07||||0.0012|TWO_SIDED|90.0|-61.41|-18.73|||Mixed Models Analysis|MMRM|Test = PF06882961 Reference = Placebo|||-18.73|-61.41|0.0012
72476925|NCT04617275|144479772|SUPERIORITY||Mean Difference (Final Values)|-45.47||||0.0003|TWO_SIDED|90.0|-66.85|-24.1||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-24.10|-66.85|0.0003
72399588|NCT02357901|144306166|SUPERIORITY||LSM difference|-9.4|STANDARD_ERROR_OF_MEAN|2.62||0.0003|TWO_SIDED|95.0|-14.56|-4.3||Significance level of 0.05.|mixed model for repeated measures|||Change from baseline was analyzed using a mixed model for repeated measures (MMRM) with terms for treatment, visit, and treatment-by-visit interaction as factors and baseline value as a covariate. Center was included in the model as a random effect.||-4.30|-14.56|0.0003
72476926|NCT04617275|144479772|SUPERIORITY||Mean Difference (Final Values)|-33.63||||0.0055|TWO_SIDED|90.0|-55.19|-12.08||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-12.08|-55.19|0.0055
72476927|NCT04617275|144479773|SUPERIORITY||Mean Difference (Final Values)|-27.79||||0.0127|TWO_SIDED|90.0|-48.12|-7.47||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-7.47|-48.12|0.0127
72476928|NCT04617275|144479773|SUPERIORITY||Mean Difference (Final Values)|-25.67||||0.0171|TWO_SIDED|90.0|-45.51|-5.83||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-5.83|-45.51|0.0171
72476929|NCT04617275|144479773|SUPERIORITY||Mean Difference (Final Values)|-46.94||||0.0001|TWO_SIDED|90.0|-67.16|-26.72||1-Sided|Mixed Models Analysis|MMRM|Test = PF06882961 Reference = Placebo|||-26.72|-67.16|0.0001
72476930|NCT04617275|144479773|SUPERIORITY||Mean Difference (Final Values)|-33.79||||0.0037|TWO_SIDED|90.0|-54.32|-13.27||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-13.27|-54.32|0.0037
72476931|NCT04617275|144479773|SUPERIORITY||Mean Difference (Final Values)|-42.13||||0.0005|TWO_SIDED|90.0|-62.85|-21.4||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-21.40|-62.85|0.0005
72476932|NCT04617275|144479774|SUPERIORITY||Mean Difference (Final Values)|-12.85||||0.1678|TWO_SIDED|90.0|-34.9|9.21||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||9.21|-34.90|0.1678
72476933|NCT04617275|144479774|SUPERIORITY||Mean Difference (Final Values)|-14.82||||0.1223|TWO_SIDED|90.0|-35.85|6.21||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||6.21|-35.85|0.1223
72476934|NCT04617275|144479774|SUPERIORITY||Mean Difference (Final Values)|-33.97||||0.0054|TWO_SIDED|90.0|-55.66|-12.28||1-Sided|Mixed Models Analysis|MMRM|Test = PF06882961 Reference = Placebo|||-12.28|-55.66|0.0054
72476935|NCT04617275|144479774|SUPERIORITY||Mean Difference (Final Values)|1.31||||0.5398|TWO_SIDED|90.0|-20.38|22.99||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||22.99|-20.38|0.5398
72508530|NCT01070550|144548030|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.842||||0.0033|TWO_SIDED|95.0|0.751|0.944|||Regression, Logistic|||The statistical analysis is presented for HCV RNA at BL in log10(IU/mL). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.944|0.751|0.0033
72508531|NCT01070550|144548030|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.477||||0.0006|TWO_SIDED|95.0|1.183|1.844|||Regression, Logistic|||The statistical analysis is presented for liver fibrosis (no cirrhosis vs cirrhosis). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.844|1.183|0.0006
72476936|NCT04617275|144479774|SUPERIORITY||Mean Difference (Final Values)|-14.42||||0.1409|TWO_SIDED|90.0|-36.56|7.72||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||7.72|-36.56|0.1409
72476937|NCT04617275|144479775|SUPERIORITY||Mean Difference (Final Values)|-28.65||||0.0236|TWO_SIDED|90.0|-52.31|-4.99||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-4.99|-52.31|0.0236
72476938|NCT04617275|144479775|SUPERIORITY||Mean Difference (Final Values)|-27.32||||0.0226|TWO_SIDED|90.0|-49.67|-4.97||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-4.97|-49.67|0.0226
72476939|NCT04617275|144479775|SUPERIORITY||Mean Difference (Final Values)|-40.85||||0.0022|TWO_SIDED|90.0|-64.11|-17.59||1-Sided|Mixed Models Analysis|MMRM|Test = PF06882961 Reference = Placebo|||-17.59|-64.11|0.0022
72476940|NCT04617275|144479775|SUPERIORITY||Mean Difference (Final Values)|-10.25||||0.2335|TWO_SIDED|90.0|-33.59|13.08||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||13.08|-33.59|0.2335
72476941|NCT04617275|144479775|SUPERIORITY||Mean Difference (Final Values)|-24.38||||0.0494|TWO_SIDED|90.0|-48.69|-0.08||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-0.08|-48.69|0.0494
72476942|NCT04617275|144479776|SUPERIORITY||Mean Difference (Final Values)|-0.09||||0.2485|TWO_SIDED|90.0|-0.31|0.13||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||0.13|-0.31|0.2485
72476943|NCT04617275|144479776|SUPERIORITY||Mean Difference (Final Values)|-0.26||||0.0252|TWO_SIDED|90.0|-0.48|-0.04||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-0.04|-0.48|0.0252
72476944|NCT04617275|144479776|SUPERIORITY||Mean Difference (Final Values)|-0.34||||0.0053|TWO_SIDED|90.0|-0.56|-0.12||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-0.12|-0.56|0.0053
72476945|NCT04617275|144479776|SUPERIORITY||Mean Difference (Final Values)|-0.32||||0.009|TWO_SIDED|90.0|-0.54|-0.1||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-0.10|-0.54|0.0090
72476946|NCT04617275|144479776|SUPERIORITY||Mean Difference (Final Values)|-0.17||||0.1066|TWO_SIDED|90.0|-0.39|0.05||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||0.05|-0.39|0.1066
72476947|NCT04617275|144479777|SUPERIORITY||Mean Difference (Final Values)|-0.11||||0.274|TWO_SIDED|90.0|-0.4|0.19||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||0.19|-0.40|0.2740
72476948|NCT04617275|144479777|SUPERIORITY||Mean Difference (Final Values)|-0.37||||0.0196|TWO_SIDED|90.0|-0.66|-0.08||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-0.08|-0.66|0.0196
72476949|NCT04617275|144479777|SUPERIORITY||Mean Difference (Final Values)|-0.59||||0.0006|TWO_SIDED|90.0|-0.88|-0.3|||Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-0.30|-0.88|0.0006
72476950|NCT04617275|144479777|SUPERIORITY||Mean Difference (Final Values)|-0.53||||0.0019|TWO_SIDED|90.0|-0.82|-0.23||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-0.23|-0.82|0.0019
72476951|NCT04617275|144479777|SUPERIORITY||Mean Difference (Final Values)|-0.36||||0.0243|TWO_SIDED|90.0|-0.66|-0.06||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-0.06|-0.66|0.0243
72476952|NCT04617275|144479778|SUPERIORITY||Mean Difference (Final Values)|-0.23||||0.1587|TWO_SIDED|90.0|-0.62|0.15||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||0.15|-0.62|0.1587
72476953|NCT04617275|144479778|SUPERIORITY||Mean Difference (Final Values)|-0.66||||0.0027|TWO_SIDED|90.0|-1.04|-0.27||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-0.27|-1.04|0.0027
72623294|NCT04875533|144777289|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the ratio of GMT20vPnC/saline to GMT13vPnC/PPSV23 for that serotype is greater than 0.5 (2-fold criterion).|Ratio of GMTs (20vPnC/PPSV23)|1.72|||||TWO_SIDED|95.0|1.44|2.06||||||Serotype 11A: GMR (the 20vPnC/saline group to the 13vPnC/PPSV23 group) and the 2-sided 95% CI||2.06|1.44|
72623295|NCT04875533|144777289|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the ratio of GMT20vPnC/saline to GMT13vPnC/PPSV23 for that serotype is greater than 0.5 (2-fold criterion).|Ratio of GMTs (20vPnC/PPSV23)|1.68|||||TWO_SIDED|95.0|1.39|2.04||||||Serotype 12F: GMR (the 20vPnC/saline group to the 13vPnC/PPSV23 group) and the 2-sided 95% CI||2.04|1.39|
72399589|NCT02357901|144306166|SUPERIORITY||LSM difference|-12.4|STANDARD_ERROR_OF_MEAN|2.61|<|0.0001|TWO_SIDED|95.0|-17.51|-7.28||Significance level of 0.05.|mixed model for repeated measures|||Change from baseline was analyzed using a mixed model for repeated measures (MMRM) with terms for treatment, visit, and treatment-by-visit interaction as factors and baseline value as a covariate. Center was included in the model as a random effect.||-7.28|-17.51|<0.0001
72476954|NCT04617275|144479778|SUPERIORITY||Mean Difference (Final Values)|-0.85||||0.0002|TWO_SIDED|90.0|-1.24|-0.47||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-0.47|-1.24|0.0002
72476955|NCT04617275|144479778|SUPERIORITY||Mean Difference (Final Values)|-0.71||||0.0016|TWO_SIDED|90.0|-1.1|-0.32||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-0.32|-1.10|0.0016
72476956|NCT04617275|144479778|SUPERIORITY||Mean Difference (Final Values)|-0.67||||0.0027|TWO_SIDED|90.0|-1.07|-0.28||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-0.28|-1.07|0.0027
72476957|NCT04617275|144479779|SUPERIORITY||Mean Difference (Final Values)|-0.43||||0.0472|TWO_SIDED|90.0|-0.86|-0.01||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-0.01|-0.86|0.0472
72476958|NCT04617275|144479779|SUPERIORITY||Mean Difference (Final Values)|-0.87||||0.0004|TWO_SIDED|90.0|-1.29|-0.45||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-0.45|-1.29|0.0004
72476959|NCT04617275|144479779|SUPERIORITY||Mean Difference (Final Values)|-1.1|||<|0.0001|TWO_SIDED|90.0|-1.53|-0.68||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-0.68|-1.53|<0.0001
72476960|NCT04617275|144479779|SUPERIORITY||Mean Difference (Final Values)|-0.93||||0.0003|TWO_SIDED|90.0|-1.36|-0.5||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-0.50|-1.36|0.0003
72476961|NCT04617275|144479779|SUPERIORITY||Mean Difference (Final Values)|-0.91||||0.0004|TWO_SIDED|90.0|-1.34|-0.47||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-0.47|-1.34|0.0004
72476962|NCT04617275|144479780|SUPERIORITY||Mean Difference (Final Values)|-0.69||||0.0116|TWO_SIDED|90.0|-1.18|-0.19||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-0.19|-1.18|0.0116
72508532|NCT01070550|144548030|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.128||||0.381|TWO_SIDED|95.0|0.862|1.477|||Regression, Logistic|||The statistical analysis is presented for liver fibrosis (not assessed/missing vs cirrhosis). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.477|0.862|0.3810
72508533|NCT01070550|144548030|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.812||||0.0279|TWO_SIDED|95.0|0.674|0.978|||Regression, Logistic|||The statistical analysis is presented for AST ratio at BL (\> 1.5 vs \<=1.5). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.978|0.674|0.0279
72508534|NCT01070550|144548030|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|45.894|||<|0.0001|TWO_SIDED|95.0|27.972|75.299|||Regression, Logistic|||The statistical analysis is presented for On-treatment response (RVR vs no RVR/EVR). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||75.299|27.972|<0.0001
72508535|NCT01070550|144548030|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|32.176|||<|0.0001|TWO_SIDED|95.0|20.129|51.434|||Regression, Logistic|||The statistical analysis is presented for on-treatment response (cEVR vs no RVR/EVR). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||51.434|20.129|<0.0001
72508536|NCT01070550|144548030|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.928|||<|0.0001|TWO_SIDED|95.0|4.291|11.188|||Regression, Logistic|||The statistical analysis is presented for on-treatment response (pEVR vs NO RVR/EVR). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||11.188|4.291|<0.0001
72508537|NCT01070550|144548030|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.733||||0.0204|TWO_SIDED|95.0|0.564|0.953|||Regression, Logistic|||The statistical analysis is presented for age per 10 years. The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.953|0.564|0.0204
72623296|NCT04875533|144777289|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the ratio of GMT20vPnC/saline to GMT13vPnC/PPSV23 for that serotype is greater than 0.5 (2-fold criterion).|Ratio of GMTs (20vPnC/PPSV23)|2.13|||||TWO_SIDED|95.0|1.72|2.64||||||Serotype 15B: GMR (the 20vPnC/saline group to the 13vPnC/PPSV23 group) and the 2-sided 95% CI||2.64|1.72|
72623297|NCT04875533|144777289|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the ratio of GMT20vPnC/saline to GMT13vPnC/PPSV23 for that serotype is greater than 0.5 (2-fold criterion).|Ratio of GMTs (20vPnC/PPSV23)|1.62|||||TWO_SIDED|95.0|1.33|1.98||||||Serotype 22F: GMR (the 20vPnC/saline group to the 13vPnC/PPSV23 group) and the 2-sided 95% CI||1.98|1.33|
72476963|NCT04617275|144479780|SUPERIORITY||Mean Difference (Final Values)|-0.94||||0.0008|TWO_SIDED|90.0|-1.43|-0.46|||Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-0.46|-1.43|0.0008
72508538|NCT01070550|144548030|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.17|||<|0.0001|TWO_SIDED|95.0|0.087|0.331|||Regression, Logistic|||The statistical analysis is presented for sex (male vs female). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.331|0.087|<0.0001
72508539|NCT01070550|144548030|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.806||||0.001|TWO_SIDED|95.0|1.514|5.201|||Regression, Logistic|||The statistical analysis is presented for on-treatment response, combined (RVR vs no RVR). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||5.201|1.514|0.0010
72508540|NCT01070550|144548030|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.663||||0.0459|TWO_SIDED|95.0|0.443|0.993|||Regression, Logistic|||The statistical analysis is presented for sex (male vs female). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.993|0.443|0.0459
72508541|NCT01070550|144548030|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.758||||0.0087|TWO_SIDED|95.0|0.616|0.932|||Regression, Logistic|||The statistical analysis is presented for HCV RNA at BL in log10(IU/mL). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.932|0.616|0.0087
72508542|NCT01070550|144548030|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.054||||0.0064|TWO_SIDED|95.0|1.224|3.447|||Regression, Logistic|||The statistical analysis is presented for liver fibrosis (no cirrhosis vs cirrhosis). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||3.447|1.224|0.0064
72508543|NCT01070550|144548030|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.931||||0.0271|TWO_SIDED|95.0|1.077|3.461|||Regression, Logistic|||The statistical analysis is presented for liver fibrosis (not assessed/missed vs cirrhosis). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||3.461|1.077|0.0271
72508544|NCT01070550|144548030|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.738||||0.0039|TWO_SIDED|95.0|1.194|2.528|||Regression, Logistic|||The statistical analysis is presented for mode of infection (other vs injection drug U). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||2.528|1.194|0.0039
72508545|NCT01070550|144548030|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.565||||0.0035|TWO_SIDED|95.0|0.386|0.829|||Regression, Logistic|||The statistical analysis is presented for AST ratio at BL (\> 1.5 vs \<=1.5). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.829|0.386|0.0035
72508546|NCT01070550|144548030|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.533||||0.0071|TWO_SIDED|95.0|1.593|19.219|||Regression, Logistic|||The statistical analysis is presented for on-treatment response (RVR vs no RVR/EVR). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||19.219|1.593|0.0071
72623298|NCT04875533|144777289|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the ratio of GMT20vPnC/saline to GMT13vPnC/PPSV23 for that serotype is greater than 0.5 (2-fold criterion).|Ratio of GMTs (20vPnC/PPSV23)|1.14|||||TWO_SIDED|95.0|0.97|1.34||||||Serotype 33F: GMR (the 20vPnC/saline group to the 13vPnC/PPSV23 group) and the 2-sided 95% CI||1.34|0.97|
72508547|NCT01070550|144548030|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.964||||0.3042|TWO_SIDED|95.0|0.542|7.114|||Regression, Logistic|||The statistical analysis is presented for on-treatment response (cEVR vs no RVR/EVR). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||7.114|0.542|0.3042
72508548|NCT01070550|144548030|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.726||||0.41|TWO_SIDED|95.0|0.471|6.318|||Regression, Logistic|||The statistical analysis is presented for on-treatment response (pEVR vs no RVR/EVR). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||6.318|0.471|0.4100
72508549|NCT01070550|144548046|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.379|||<|0.0001|TWO_SIDED|95.0|1.236|1.538|||Regression, Logistic|||The statistical analysis is presented for age per 10 years. The logistic regression analysis for relapse 24 weeks after EOT was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.538|1.236|<0.0001
72508550|NCT01070550|144548046|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.033||||0.0251|TWO_SIDED|95.0|1.004|1.063|||Regression, Logistic|||The statistical analysis is presented for BMI in kg/m\^2. The logistic regression analysis for relapse 24 Weeks after EOT was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.063|1.004|0.0251
72623299|NCT00330733|144777328|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05|||||||t-test, 2 sided|||Paired comparisons (follow-up vs baseline) and unpaired group comparisons were performed by Student's t tests or Wilcoxon signed rank tests.||||<0.05
72399590|NCT02357901|144306167|SUPERIORITY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|stratified by site||||||<0.0001
72399591|NCT02357901|144306167|SUPERIORITY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|stratified by site||||||<0.0001
72399592|NCT02357901|144306168|SUPERIORITY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|stratified by site||||||<0.0001
72399593|NCT02357901|144306168|SUPERIORITY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|stratified by site||||||<0.0001
72476964|NCT04617275|144479780|SUPERIORITY||Mean Difference (Final Values)|-1.16|||<|0.0001|TWO_SIDED|90.0|-1.66|-0.67||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-0.67|-1.66|<0.0001
72476965|NCT04617275|144479780|SUPERIORITY||Mean Difference (Final Values)|-0.9||||0.0017|TWO_SIDED|90.0|-1.4|-0.4||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-0.40|-1.40|0.0017
72476966|NCT04617275|144479780|SUPERIORITY||Mean Difference (Final Values)|-1.05||||0.0004|TWO_SIDED|90.0|-1.55|-0.55||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-0.55|-1.55|0.0004
72476967|NCT04617275|144479781|SUPERIORITY||Mean Difference (Final Values)|-0.76||||0.0132|TWO_SIDED|90.0|-1.32|-0.2||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-0.20|-1.32|0.0132
72476968|NCT04617275|144479781|SUPERIORITY||Mean Difference (Final Values)|-1.0||||0.0014|TWO_SIDED|90.0|-1.55|-0.46||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-0.46|-1.55|0.0014
72476969|NCT04617275|144479781|SUPERIORITY||Mean Difference (Final Values)|-1.25||||0.0002|TWO_SIDED|90.0|-1.8|-0.69||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-0.69|-1.80|0.0002
72476970|NCT04617275|144479781|SUPERIORITY||Mean Difference (Final Values)|-0.73||||0.0174|TWO_SIDED|90.0|-1.29|-0.16|||Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-0.16|-1.29|0.0174
72476971|NCT04617275|144479781|SUPERIORITY||Mean Difference (Final Values)|-1.25||||0.0002|TWO_SIDED|90.0|-1.82|-0.69||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-0.69|-1.82|0.0002
72476972|NCT04617275|144479782|SUPERIORITY||Mean Difference (Final Values)|-0.26||||0.2843|TWO_SIDED|90.0|-1.02|0.5||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||0.50|-1.02|0.2843
72476973|NCT04617275|144479782|SUPERIORITY||Mean Difference (Final Values)|-0.08||||0.431|TWO_SIDED|90.0|-0.84|0.68||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||0.68|-0.84|0.4310
72476974|NCT04617275|144479782|SUPERIORITY||Mean Difference (Final Values)|-0.32||||0.2402|TWO_SIDED|90.0|-1.07|0.43||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||0.43|-1.07|0.2402
72476975|NCT04617275|144479782|SUPERIORITY||Mean Difference (Final Values)|-0.49||||0.1397|TWO_SIDED|90.0|-1.24|0.26||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||0.26|-1.24|0.1397
72476976|NCT04617275|144479782|SUPERIORITY||Mean Difference (Final Values)|-0.07||||0.4393|TWO_SIDED|90.0|-0.85|0.71||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||0.71|-0.85|0.4393
72476977|NCT04617275|144479783|SUPERIORITY||Mean Difference (Final Values)|-0.77||||0.1491|TWO_SIDED|90.0|-2.0|0.45||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||0.45|-2.00|0.1491
72476978|NCT04617275|144479783|SUPERIORITY||Median Difference (Final Values)|0.12||||0.5664|TWO_SIDED|90.0|-1.09|1.34||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||1.34|-1.09|0.5664
72476979|NCT04617275|144479783|SUPERIORITY||Median Difference (Final Values)|-1.12||||0.0632|TWO_SIDED|90.0|-2.33|0.09||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||0.09|-2.33|0.0632
72476980|NCT04617275|144479783|SUPERIORITY||Median Difference (Final Values)|-1.01||||0.0847|TWO_SIDED|90.0|-2.23|0.2||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||0.20|-2.23|0.0847
72476981|NCT04617275|144479783|SUPERIORITY||Mean Difference (Final Values)|0.05||||0.5264|TWO_SIDED|90.0|-1.2|1.3||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||1.30|-1.20|0.5264
72476982|NCT04617275|144479784|SUPERIORITY||Mean Difference (Final Values)|-1.48||||0.0395|TWO_SIDED|90.0|-2.86|-0.1||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-0.10|-2.86|0.0395
72476983|NCT04617275|144479784|SUPERIORITY||Mean Difference (Final Values)|-0.27||||0.3726|TWO_SIDED|90.0|-1.63|1.1||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||1.10|-1.63|0.3726
72476984|NCT04617275|144479784|SUPERIORITY||Mean Difference (Final Values)|-2.36||||0.0028|TWO_SIDED|90.0|-3.74|-0.98||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-0.98|-3.74|0.0028
72476985|NCT04617275|144479784|SUPERIORITY||Mean Difference (Final Values)|-1.85||||0.0139|TWO_SIDED|90.0|-3.23|-0.47||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-0.47|-3.23|0.0139
72476986|NCT04617275|144479784|SUPERIORITY||Mean Difference (Final Values)|-0.78||||0.1815|TWO_SIDED|90.0|-2.19|0.64||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||0.64|-2.19|0.1815
72476987|NCT04617275|144479785|SUPERIORITY||Mean Difference (Final Values)|-2.16||||0.0112|TWO_SIDED|90.0|-3.71|-0.61||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-0.61|-3.71|0.0112
72476988|NCT04617275|144479785|SUPERIORITY||Mean Difference (Final Values)|-0.72||||0.2161|TWO_SIDED|90.0|-2.24|0.8||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||0.80|-2.24|0.2161
72476989|NCT04617275|144479785|SUPERIORITY||Mean Difference (Final Values)|-3.47||||0.0002|TWO_SIDED|90.0|-5.02|-1.92||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-1.92|-5.02|0.0002
72476990|NCT04617275|144479785|SUPERIORITY||Mean Difference (Final Values)|-2.05||||0.0147|TWO_SIDED|90.0|-3.59|-0.51||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-0.51|-3.59|0.0147
72476991|NCT04617275|144479785|SUPERIORITY||Mean Difference (Final Values)|-2.97||||0.0013|TWO_SIDED|90.0|-4.56|-1.37||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-1.37|-4.56|0.0013
72476992|NCT04617275|144479786|SUPERIORITY||Mean Difference (Final Values)|-2.46||||0.0111|TWO_SIDED|90.0|-4.22|-0.7||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-0.70|-4.22|0.0111
72476993|NCT04617275|144479786|SUPERIORITY||Mean Difference (Final Values)|-1.03||||0.16|TWO_SIDED|90.0|-2.75|0.68||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||0.68|-2.75|0.1600
72476994|NCT04617275|144479786|SUPERIORITY||Mean Difference (Final Values)|-4.27|||<|0.0001|TWO_SIDED|90.0|-6.03|-2.52||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-2.52|-6.03|<0.0001
72476995|NCT04617275|144479786|SUPERIORITY||Mean Difference (Final Values)|-2.68||||0.0061|TWO_SIDED|90.0|-4.42|-0.94||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-0.94|-4.42|0.0061
72399594|NCT02357901|144306169|SUPERIORITY||LSM difference|-0.7|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-0.96|-0.46||Significance level of 0.05.|mixed model for repeated measures|||Change from baseline was analyzed using a mixed model for repeated measures (MMRM) with terms for treatment, visit, and treatment-by-visit interaction as factors and baseline value as a covariate. Center was included in the model as a random effect.||-0.46|-0.96|<0.0001
72399595|NCT02357901|144306169|SUPERIORITY||LSM difference|-0.9|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-1.12|-0.62||Significance level of 0.05.|mixed model for repeated measures|||Change from baseline was analyzed using a mixed model for repeated measures (MMRM) with terms for treatment, visit, and treatment-by-visit interaction as factors and baseline value as a covariate. Center was included in the model as a random effect.||-0.62|-1.12|<0.0001
72399596|NCT02357901|144306170|SUPERIORITY||LSM difference|-0.6|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-0.89|-0.33||Significance level of 0.05.|mixed model for repeated measures|||Change from baseline was analyzed using a mixed model for repeated measures (MMRM) with terms for treatment, visit, and treatment-by-visit interaction as factors and baseline value as a covariate. Center was included in the model as a random effect.||-0.33|-0.89|<0.0001
72399597|NCT02357901|144306170|SUPERIORITY||LSM difference|-0.7|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-0.97|-0.41||Significance level of 0.05.|mixed model for repeated measures|||Change from baseline was analyzed using a mixed model for repeated measures (MMRM) with terms for treatment, visit, and treatment-by-visit interaction as factors and baseline value as a covariate. Center was included in the model as a random effect.||-0.41|-0.97|<0.0001
72399598|NCT02357901|144306171|SUPERIORITY||LSM difference|-0.4|STANDARD_ERROR_OF_MEAN|0.38||0.3143|TWO_SIDED|95.0|-1.13|0.36||Significance level of 0.05.|mixed model for repeated measures|||Change from baseline was analyzed using a mixed model for repeated measures (MMRM) with terms for treatment, visit, and treatment-by-visit interaction as factors and baseline value as a covariate. Center was included in the model as a random effect.||0.36|-1.13|0.3143
72399599|NCT02357901|144306171|SUPERIORITY||LSM difference|-1.0|STANDARD_ERROR_OF_MEAN|0.38||0.0101|TWO_SIDED|95.0|-1.72|-0.23||Significance level of 0.05.|mixed model for repeated measures|||Change from baseline was analyzed using a mixed model for repeated measures (MMRM) with terms for treatment, visit, and treatment-by-visit interaction as factors and baseline value as a covariate. Center was included in the model as a random effect.||-0.23|-1.72|0.0101
72399600|NCT02357901|144306172|SUPERIORITY||LSM difference|-1.6|STANDARD_ERROR_OF_MEAN|0.87||0.0726|TWO_SIDED|95.0|-3.29|0.14||Significance level of 0.05.|mixed model for repeated measures|||Change from baseline was analyzed using a mixed model for repeated measures (MMRM) with terms for treatment, visit, and treatment-by-visit interaction as factors and baseline value as a covariate. Center was included in the model as a random effect.||0.14|-3.29|0.0726
72476996|NCT04617275|144479786|SUPERIORITY||Mean Difference (Final Values)|-3.71||||0.0005|TWO_SIDED|90.0|-5.52|-1.89||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-1.89|-5.52|0.0005
72508551|NCT01070550|144548046|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.585|||<|0.0001|TWO_SIDED|95.0|1.358|1.849|||Regression, Logistic|||The statistical analysis is presented for HCV RNA at BL in log10(IU/mL). The logistic regression analysis for relapse 24 Weeks after EOT was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.849|1.358|<0.0001
72508552|NCT01070550|144548046|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.501||||0.0317|TWO_SIDED|95.0|1.036|2.174|||Regression, Logistic|||The statistical analysis is presented for ALT ratio at BL (\<=1 vs \> 3). The logistic regression analysis for relapse 24 Weeks after EOT was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||2.174|1.036|0.0317
72399601|NCT02357901|144306172|SUPERIORITY||LSM difference|-2.6|STANDARD_ERROR_OF_MEAN|0.87||0.0028|TWO_SIDED|95.0|-4.32|-0.9||Significance level of 0.05.|mixed model for repeated measures|||Change from baseline was analyzed using a mixed model for repeated measures (MMRM) with terms for treatment, visit, and treatment-by-visit interaction as factors and baseline value as a covariate. Center was included in the model as a random effect.||-0.90|-4.32|0.0028
72399602|NCT02357901|144306173|SUPERIORITY||LSM difference|7.5|STANDARD_ERROR_OF_MEAN|0.86|<|0.0001|TWO_SIDED|95.0|5.81|9.2||Significance level of 0.05.|ANOVA|a random effects ANOVA model with treatment included as fixed effect and center as random effect.||||9.20|5.81|<0.0001
72399603|NCT02357901|144306173|SUPERIORITY||LSM difference|7.5|STANDARD_ERROR_OF_MEAN|0.86|<|0.0001|TWO_SIDED|95.0|5.82|9.21||Significance level of 0.05.|ANOVA|a random effects ANOVA model with treatment included as fixed effect and center as random effect.||||9.21|5.82|<0.0001
72399604|NCT04788953|144306177|SUPERIORITY||||||<|0.001||||||Change from baseline using mixed-effects tobit regression model (censored normal). Group (Solriamfetol, Placebo), visit (Baseline, End-of-Treatment), trial (1-4) main factors and their interactions. Covariates considered: age, sex, ethnicity, race.|Mixed Models Analysis|P-value is difference between groups.||The statistical null hypothesis was that solriamfetol does not improve change in MWT scores versus placebo after 4 weeks of treatment (H0: µsol - µpl ≤ 0). Study was designed to have 97% power to detect a difference of 5.7 minutes or greater on MWT sleep latency (α=0.05, assumed σ=7.2) with 100 participants. Blinded interim power analysis on the baseline data conducted in October 2023 indicated the trial would have \>99% power to detect a similar difference with only 74 participants.||||<0.001
72399605|NCT04788953|144306178|SUPERIORITY||||||<|0.001||||||Change from baseline using mixed-effects linear regression model. Group (Solriamfetol, Placebo), visit (Baseline, End-of-Treatment), trial (1-4) main factors and their interactions. Covariates considered: age, sex, ethnicity, race.|Mixed Models Analysis|P-value is difference between groups.||||||<0.001
72476997|NCT04617275|144479787|SUPERIORITY||Mean Difference (Final Values)|-3.21||||0.0047|TWO_SIDED|90.0|-5.22|-1.2||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-1.20|-5.22|0.0047
72476998|NCT04617275|144479787|SUPERIORITY||Mean Difference (Final Values)|-1.51||||0.1003|TWO_SIDED|90.0|-3.45|0.44||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||0.44|-3.45|0.1003
72476999|NCT04617275|144479787|SUPERIORITY||Mean Difference (Final Values)|-4.95|||<|0.0001|TWO_SIDED|90.0|-6.96|-2.95||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-2.95|-6.96|<0.0001
72623300|NCT01979185|144777355|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|If the 90% CI of the geometric mean ratios fell within the range (0.80, 1.25), then equivalence was assumed and the hypothesis that a drug interaction occurred was rejected. If the 90% CIs were not wholly contained within the range (0.80, 1.25), then a drug interaction was not excluded.|Ratio of Geometric LS Means|0.632|||||TWO_SIDED|90.0|0.538|0.744|||Mixed-effects Model|||The means of the log-transformed pharmacokinetic parameters were compared between treatments using a mixed-effects model with period and treatment as fixed effects, and subject nested within sequence as a random effect. In order to estimate the magnitude of the treatment regimen differences in pharmacokinetic parameters, the geometric mean ratio (i.e., the least squares mean difference in the log-transformed parameters back transformed to the original scale) and their 90% CIs were calculated.||0.744|0.538|
72477000|NCT04617275|144479787|SUPERIORITY||Mean Difference (Final Values)|-2.5||||0.0197|TWO_SIDED|90.0|-4.49|-0.51||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-0.51|-4.49|0.0197
72477001|NCT04617275|144479787|SUPERIORITY||Mean Difference (Final Values)|-4.94|||<|0.0001|TWO_SIDED|90.0|-7.03|-2.85||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-2.85|-7.03|<0.0001
72508553|NCT01070550|144548046|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.493||||0.0129|TWO_SIDED|95.0|1.089|2.048|||Regression, Logistic|||The statistical analysis is presented for ALT ratio at BL (\> 1 - 3 vs \> 3). The logistic regression analysis for relapse 24 Weeks after EOT was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||2.048|1.089|0.0129
72508554|NCT01070550|144548046|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.616||||0.0128|TWO_SIDED|95.0|1.107|2.357|||Regression, Logistic|||The statistical analysis is presented for Platelets x 10\^9/L at BL (\< 140 vs \>=180). The logistic regression analysis for relapse 24 Weeks after EOT was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||2.357|1.107|0.0128
72399606|NCT04788953|144306179|SUPERIORITY|||||||0.01||||||"Chi-squared tests performed on dichotomized CGI-Change data (Improved \[very much improved, much improved, minimally improved\] vs. Not Improved \[no change, minimally worse, much worse, very much worse\])."|Chi-squared|P-value is difference between groups.||||||0.01
72508555|NCT01070550|144548046|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.046||||0.7809|TWO_SIDED|95.0|0.763|1.432|||Regression, Logistic|||The statistical analysis is presented for Platelets x 10\^9/L at BL (\>=140 - \< 180 vs \>=180). The logistic regression analysis for relapse 24 Weeks after EOT was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.432|0.763|0.7809
72508556|NCT01070550|144548046|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.969|||<|0.0001|TWO_SIDED|95.0|0.962|0.976|||Regression, Logistic|||The statistical analysis is presented for treatment duration after VR in weeks. The logistic regression analysis for relapse 24 Weeks after EOT was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.976|0.962|<0.0001
72508557|NCT01070550|144548046|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.298||||0.0189|TWO_SIDED|95.0|1.273|14.512|||Regression, Logistic|||The statistical analysis is presented for Cumulative PEG-IFN alfa-2a dose per 1000 ug, first 12 weeks. The logistic regression analysis for relapse 24 Weeks after EOT was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||14.512|1.273|0.0189
72477002|NCT04617275|144479788|SUPERIORITY||Mean Difference (Final Values)|-0.96||||0.0836|TWO_SIDED|90.0|-2.12|0.19||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||0.19|-2.12|0.0836
72477003|NCT04617275|144479789|SUPERIORITY||Mean Difference (Final Values)|-1.59||||0.0386|TWO_SIDED|90.0|-3.07|-0.12||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-0.12|-3.07|0.0386
72477004|NCT04617275|144479790|SUPERIORITY||Mean Difference (Final Values)|-1.5||||0.1566|TWO_SIDED|90.0|-3.99|1.0||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||1.00|-3.99|0.1566
72508558|NCT01070550|144548046|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.567||||0.0316|TWO_SIDED|95.0|1.04|2.359|||Regression, Logistic|||The statistical analysis is presented for age per 10 years. The logistic regression analysis for relapse 24 weeks after EOT was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||2.359|1.040|0.0316
72508559|NCT01070550|144548046|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.495||||0.0024|TWO_SIDED|95.0|1.701|11.879|||Regression, Logistic|||The statistical analysis is presented for sex (male vs female). The logistic regression analysis for relapse 24 Weeks after EOT was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||11.879|1.701|0.0024
72477005|NCT04617275|144479791|SUPERIORITY||Mean Difference (Final Values)|-2.62||||0.0916|TWO_SIDED|90.0|-5.91|0.67||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||0.67|-5.91|0.0916
72477006|NCT04617275|144479792|SUPERIORITY||Mean Difference (Final Values)|-3.07||||0.059|TWO_SIDED|90.0|-6.31|0.17||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||0.17|-6.31|0.0590
72477007|NCT04617275|144479793|SUPERIORITY||Mean Difference (Final Values)|-3.74||||0.0826|TWO_SIDED|90.0|-8.23|0.75||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||0.75|-8.23|0.0826
72399607|NCT04788953|144306181|SUPERIORITY|Change from baseline using mixed-effects linear regression model. Group (Solriamfetol vs. Placebo) and visit (Baseline vs. End-of-Treatment) as main factors and their interactions. Covariates considered: age, sex, ethnicity, race.||||||0.02|||||||Mixed Models Analysis|P-value is difference between groups.||||||0.02
72399608|NCT04788953|144306182|SUPERIORITY|||||||0.64||||||Change from baseline using mixed-effects linear regression model. Group (Solriamfetol vs. Placebo) and visit (Baseline vs. End-of-Treatment) as main factors and their interactions. Covariates considered: age, sex, ethnicity, race.|Mixed Models Analysis|P-value is difference between groups.||||||0.64
72399609|NCT04788953|144306183|SUPERIORITY|||||||0.04||||||Change from baseline using mixed-effects linear regression model. Group (Solriamfetol vs. Placebo) and visit (Baseline vs. End-of-Treatment) as main factors and their interactions. Covariates considered: age, sex, ethnicity, race.|Mixed Models Analysis|P-value is difference between groups.||||||0.04
72477008|NCT05593445|144479827|SUPERIORITY||Odds Ratio (OR)|0.83||||0.737|TWO_SIDED|95.0|0.29|2.41|||Chi-squared|||||2.41|0.29|0.737
72477009|NCT05593445|144479827|SUPERIORITY||response rate difference|-4.3|STANDARD_ERROR_OF_MEAN|12.73|||TWO_SIDED|95.0|-29.2|20.7|||||The 95% confidence interval for the response rate difference was constructed from approximately normal distribution.|||20.7|-29.2|
72477010|NCT05593445|144479828|SUPERIORITY||least squares mean difference|-2.76|STANDARD_ERROR_OF_MEAN|1.14||0.0188|TWO_SIDED|95.0|-5.05|-0.47|||Mixed Model Repeated Measures (MMRM)|||||-0.47|-5.05|0.0188
72477011|NCT05593445|144479829|SUPERIORITY||least squares mean difference|-0.53|STANDARD_ERROR_OF_MEAN|0.72||0.4674|TWO_SIDED|95.0|-1.96|0.91|||MMRM|||||0.91|-1.96|0.4674
72477012|NCT05593445|144479830|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.9072|TWO_SIDED|95.0|0.503|1.869|||Log Rank||Cox regression model was conducted to compare the difference in hazard rate.|||1.869|0.503|0.9072
72477013|NCT05559476|144479839|NON_INFERIORITY|The non-inferiority is demonstrated if the Upper Limit (UL) of the 2-sided 95% Confidence Interval (CI) of the GMT ratio (Control group divided by Co-Ad group) for RSVPreF3 OA vaccine is less than or equal (\<=)1.5.|GMT Ratio|1.18|||||TWO_SIDED|95.0|1.03|1.35|||||The comparison is done using the adjusted group ratio of GMT (ANCOVA model applied to the logarithm- transformed titers). The ANCOVA model included the treatment group, the age category as fixed effects and the pre-dose log-10 titer as covariate.|To demonstrate the non-inferiority of the RSVPreF3 OA vaccine when co-administered with the FLU vaccine compared to the RSVPreF3 OA vaccine administered alone, in terms of RSV-A neutralizing antibody titers, at 1 month after the RSVPreF3 OA vaccine dose (Day 31 for the Co-Ad Group and Day 61 for the Control Group).||1.35|1.03|
72477014|NCT05559476|144479840|NON_INFERIORITY|The non-inferiority is demonstrated if the UL of the 2-sided 95% CI of the group GMT ratio (Control group divided by Co-Ad group) for HI antibody titers for the Flu strain is \<=1.5.|GMT Ratio|0.99|||||TWO_SIDED|95.0|0.85|1.16|||||The comparison was done using the adjusted group ratio of GMT (ANCOVA model applied to the logarithm- transformed titers). The ANCOVA model included the treatment group, the age category as fixed effects and the pre-dose log-10 titer as covariate.|To demonstrate the non-inferiority of the FLU vaccine when co-administered with the RSVPreF3 OA vaccine compared to the FLU vaccine administered alone, in terms of HI GMTs against the Flu A/Darwin/6/2021 H3N2 influenza strain, at 1 month post-FLU vaccine dose administration (Day 31 for both groups).||1.16|0.85|
72508560|NCT01070550|144548046|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.112||||0.0247|TWO_SIDED|95.0|1.014|1.219|||Regression, Logistic|||The statistical analysis is presented for BMI in kg/m\^2. The logistic regression analysis for relapse 24 weeks after EOT was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.219|1.014|0.0247
72508561|NCT01070550|144548046|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.844||||0.0258|TWO_SIDED|95.0|1.077|3.158|||Regression, Logistic|||The statistical analysis is presented for HCV RNA at BL in log10(IU/mL). The logistic regression analysis for relapse 24 weeks after EOT was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||3.158|1.077|0.0258
72399610|NCT04788953|144306184|SUPERIORITY|||||||0.61||||||Change from baseline using mixed-effects linear regression model. Group (Solriamfetol vs. Placebo) and Condition (Baseline vs. Treatment) as main factors and their interactions. Covariates considered: age, sex, ethnicity, race.|Mixed Models Analysis|P-value is difference between groups.||||||0.61
72399611|NCT04788953|144306185|SUPERIORITY|||||||0.57||||||Change from baseline using mixed-effects linear regression model. Group (Solriamfetol vs. Placebo) and Condition (Baseline vs. Treatment) as main factors and their interactions. Covariates considered: age, sex, ethnicity, race.|Mixed Models Analysis|P-value is difference between groups.||||||0.57
72508562|NCT01070550|144548046|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.677||||0.0007|TWO_SIDED|95.0|1.243|2.263|||Regression, Logistic|||The statistical analysis is presented for age per 10 years. The logistic regression analysis for relapse 24 weeks after EOT was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||2.263|1.243|0.0007
72399612|NCT04788953|144306186|SUPERIORITY||||||<|0.001||||||Change from baseline using mixed-effects linear regression model. Group (Solriamfetol vs. Placebo) and visit (Baseline vs. End-of-Treatment) as main factors and their interactions. Covariates considered: age, sex, ethnicity, race.|Mixed Models Analysis|P-value is difference between groups.||||||<0.001
72399613|NCT04262232|144306366|SUPERIORITY||Mean Difference (Net)|-1.8||||0.0001|TWO_SIDED|95.0|-2.6|-0.95|||Paired t-test, two-sided||Baseline value minus two weeks post-intervention value.|||-0.95|-2.6|0.0001
72477015|NCT05559476|144479840|NON_INFERIORITY|The non-inferiority is demonstrated if the UL of the 2-sided 95% CI of the group GMT ratio (Control group divided by Co-Ad group) for HI antibody titers for the Flu strain is \<=1.5.|GMT Ratio|0.93|||||TWO_SIDED|95.0|0.8|1.09|||||The comparison was done using the adjusted group ratio of GMT (ANCOVA model applied to the logarithm- transformed titers). The ANCOVA model included the treatment group, the age category as fixed effects and the pre-dose log-10 titer as covariate.|To demonstrate the non-inferiority of the FLU vaccine when co-administered with the RSVPreF3 OA vaccine compared to the FLU vaccine administered alone, in terms of HI GMTs against the Flu A/Victoria/2570/2019 H1N1 influenza strain, at 1 month post-FLU vaccine dose administration (Day 31 for both groups).||1.09|0.80|
72399614|NCT04262232|144306367|SUPERIORITY||Mean Difference (Net)|1.4|||<|0.0001|TWO_SIDED|95.0|1.17|1.63|||Paired t-test, two-sided||Baseline value minus two weeks post-intervention value.|||1.63|1.17|<0.0001
72399615|NCT04262232|144306369|SUPERIORITY||Mean Difference (Net)|-2.8||||0.01|TWO_SIDED|95.0|-4.99|-0.61|||Paired t-test, two-sided||Baseline value minus two weeks post-intervention value.|||-0.61|-4.99|0.01
72477016|NCT05559476|144479840|NON_INFERIORITY|The non-inferiority is demonstrated if the UL of the 2-sided 95% CI of the group GMT ratio (Control group divided by Co-Ad group) for HI antibody titers for the Flu strain is \<=1.5.|GMT Ratio|0.95|||||TWO_SIDED|95.0|0.88|1.03|||||The comparison was done using the adjusted group ratio of GMT (ANCOVA model applied to the logarithm- transformed titers). The ANCOVA model included the treatment group, the age category as fixed effects and the pre-dose log-10 titer as covariate.|To demonstrate the non-inferiority of the FLU vaccine when co administered with the RSVPreF3 OA vaccine compared to the FLU vaccine administered alone, in terms of HI GMTs against the Flu B/Austria/1359417/2021 influenza strain, at 1 month post-FLU vaccine dose administration (Day 31 for both groups).||1.03|0.88|
72477017|NCT05559476|144479840|NON_INFERIORITY|The non-inferiority is demonstrated if the UL of the 2-sided 95% CI of the group GMT ratio (Control group divided by Co-Ad group) for HI antibody titers for the Flu strain is \<=1.5.|GMT Ratio|0.93|||||TWO_SIDED|95.0|0.84|1.02|||||The comparison was done using the adjusted group ratio of GMT (ANCOVA model applied to the logarithm- transformed titers). The ANCOVA model included the treatment group, the age category as fixed effects and the pre-dose log-10 titer as covariate.|To demonstrate the non-inferiority of the FLU vaccine when co administered with the RSVPreF3 OA vaccine compared to the FLU vaccine administered alone, in terms of HI GMTs against the Flu B/Phuket/3073/2013 Yamagata influenza strain, at 1 month post-FLU vaccine dose administration (Day 31 for both groups).||1.02|0.84|
72477018|NCT05559476|144479841|NON_INFERIORITY|The non-inferiority is demonstrated if the UL of the 2-sided 95% CI of the GMT ratio (Control group divided by Co-Ad group) for RSVPreF3 OA vaccine is \<=1.5.|GMT Ratio|1.01|||||TWO_SIDED|95.0|0.89|1.15|||||The comparison was done using the adjusted group ratio of GMT (ANCOVA model applied to the logarithm- transformed titers). The ANCOVA model included the treatment group, the age category as fixed effects and the pre-dose log-10 titer as covariate.|To demonstrate the non-inferiority of the RSVPreF3 OA vaccine when co-administered with the FLU vaccine compared to the RSVPreF3 OA vaccine administered alone, in terms of RSV-B neutralizing antibody titers, at 1 month after the RSVPreF3 OA vaccine dose (Day 31 for the Co-Ad Group and Day 61 for the Control Group).||1.15|0.89|
72508563|NCT01070550|144548046|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.384||||0.0002|TWO_SIDED|95.0|1.166|1.641|||Regression, Logistic|||The statistical analysis is presented for weight per 10 kg. The logistic regression analysis for relapse 24 weeks after EOT was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.641|1.166|0.0002
72508564|NCT01070550|144548046|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.09||||0.0002|TWO_SIDED|95.0|1.421|3.074|||Regression, Logistic|||The statistical analysis is presented for HCV RNA at BL in log10 (IU/mL). The logistic regression analysis for relapse 24 Weeks after EOT was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||3.074|1.421|0.0002
72508565|NCT01070550|144548046|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.288||||0.0006|TWO_SIDED|95.0|0.141|0.588|||Regression, Logistic|||The statistical analysis is presented for liver fibrosis (no cirrhosis vs cirrhosis). The logistic regression analysis for relapse 24 Weeks after EOT was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.588|0.141|0.0006
72508566|NCT01070550|144548046|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.247||||0.0013|TWO_SIDED|95.0|0.106|0.579|||Regression, Logistic|||The statistical analysis is presented for liver fibrosis (not assessed/missing vs cirrhosis). The logistic regression analysis for relapse 24 Weeks after EOT was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.579|0.106|0.0013
72508567|NCT01070550|144548046|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.959||||0.0062|TWO_SIDED|95.0|0.931|0.988|||Regression, Logistic|||The statistical analysis is presented for treatment duration after VR in weeks. The logistic regression analysis for relapse 24 Weeks after EOT was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.988|0.931|0.0062
72508568|NCT01070550|144548046|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.708||||0.002|TWO_SIDED|95.0|0.568|0.881|||Regression, Logistic|||The statistical analysis is presented for cumulative ribavirin dose per 10000 mg, first 12 weeks. The logistic regression analysis for relapse 24 weeks after EOT was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.881|0.568|0.0020
72508569|NCT01070550|144548046|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.434|||<|0.0001|TWO_SIDED|95.0|1.288|1.596|||Regression, Logistic|||The statistical analysis is presented for age per 10 years. The logistic regression analysis for relapse 24 Weeks after EOT was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.596|1.288|<0.0001
72399616|NCT04262232|144306371|SUPERIORITY||Mean Difference (Net)|0.5||||0.51|TWO_SIDED|95.0|-1.02|2.02|||Paired t-test, two-sided||Baseline value minus two weeks post-intervention value.|||2.02|-1.02|0.51
72399617|NCT01975909|144306372|EQUIVALENCE|We hypothesized that the real TMS would improve the performance of SARA (i.e., greater percent decrease of SARA score from baseline) as compared to the sham TMS.||||||0.29|||||||t-test, 2 sided|||||||0.29
72399618|NCT01975909|144306373|EQUIVALENCE|We hypothesized that the real TMS would improve the performance of 25-foot walking test (i.e., greater percent increase of walking speed from baseline) as compared to the sham TMS.||||||0.47|||||||t-test, 2 sided|||||||0.47
72477019|NCT05559476|144479842|NON_INFERIORITY|The non-inferiority is demonstrated if the UL of the 2-sided 95% CI on the group difference (Control group minus Co-Ad group) in terms of SCR is \<=10% for anti-HI antibodies.|Difference of Percentage|-1.71|||||TWO_SIDED|95.0|-8.15|4.74||||||To evaluate the non-inferiority of the FLU vaccine when co-administered with the RSVPreF3 OA vaccine compared to the FLU vaccine administered alone as measured by the difference of percentage of participants achieving seroconversion for HI antibody titers against Flu A/Darwin/6/2021 H3N2 strain at 1 month post-FLU vaccine dose administration (Day 31 for both groups).||4.74|-8.15|
72477020|NCT05559476|144479842|NON_INFERIORITY|The non-inferiority is demonstrated if the UL of the 2-sided 95% CI on the group difference (Control group minus Co-Ad group) in terms of SCR is \<=10% for anti-HI antibodies.|Difference of Percentage|-4.11|||||TWO_SIDED|95.0|-10.67|2.48||||||To evaluate the non-inferiority of the FLU vaccine when co administered with the RSVPreF3 OA vaccine compared to the FLU vaccine administered alone as measured by the difference of percentage of participants achieving seroconversion for HI antibody titers against Flu A/Victoria/2570/2019 H1N1 strain at 1 month post-FLU vaccine dose administration (Day 31 for both groups).||2.48|-10.67|
72477021|NCT05559476|144479842|NON_INFERIORITY|The non-inferiority is demonstrated if the UL of the 2-sided 95% CI on the group difference (Control group minus Co-Ad group) in terms of SCR is \<=10% for anti-HI antibodies.|Difference of Percentage|-8.56|||||TWO_SIDED|95.0|-14.75|-2.29||||||To evaluate the non-inferiority of the FLU vaccine when co-administered with the RSVPreF3 OA vaccine compared to the FLU vaccine administered alone as measured by the difference of percentage of participants achieving seroconversion for HI antibody titers against Flu B/Austria/1359417/2021 Victoria at 1 month post-FLU vaccine dose administration (Day 31 for both groups).||-2.29|-14.75|
72477022|NCT05559476|144479842|NON_INFERIORITY|The non-inferiority is demonstrated if the UL of the 2-sided 95% CI on the group difference (Control group minus Co-Ad group) in terms of SCR is \<=10% for anti-HI antibodies.|Difference of Percentage|-5.89|||||TWO_SIDED|95.0|-12.28|0.56||||||To evaluate the non-inferiority of the FLU vaccine when co-administered with the RSVPreF3 OA vaccine compared to the FLU vaccine administered alone as measured by the difference of percentage of participants achieving seroconversion for HI antibody titers against Flu B/Phuket/3073/2013 Yamagata strain at 1 month post-FLU vaccine dose administration (Day 31 for both groups).||0.56|-12.28|
72477023|NCT00775463|144479868|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehmann Estimate of Treatment Eff|0.0||||0.2|TWO_SIDED|95.0|-1.0|0.0|||Cochran-Mantel-Haenszel|||A Cochran-Mantel Haenszel mean score test was used on the standardized reverse mid-ranks (overall reverse ranks divided by the number of ranks +1, or modified ridit scores; largely negative changes had ranks near 1 and largely positive changes had ranks near 0)of the residuals from an ordinary least squares regression with change in net ulcer burden at Week 20 as a linear function of Baseline PDEI or prostacyclin use (binary variable:Yes/No) and net ulcer burden at Baseline(continuous variable).||0.0|-1.0|0.20
72477024|NCT00775463|144479869|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehmann Estimate of Treatment Eff|-0.4||||0.31|TWO_SIDED|95.0|-1.4|0.4||Analyses of secondary endpoints were descriptive in nature, no adjustments for multiplicity were made. P-values are for the purpose of describing the random imbalance between treatment groups and not to test formal hypotheses.|Wilcoxon (Mann-Whitney)|||The difference between treatment groups for the change from Baseline was tested using the Wilcoxon rank-sum test.||0.40|-1.40|0.31
72477025|NCT00775463|144479870|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehmann Estimate of Treatment Eff|-9.3||||0.12|TWO_SIDED|95.0|-21.3|2.7||Analyses of secondary endpoints were descriptive in nature, no adjustments for multiplicity were made. P-values are for the purpose of describing the random imbalance between treatment groups and not to test formal hypotheses.|Wilcoxon (Mann-Whitney)|||The VAS-global assessments were recorded in centimeters, with possible values ranging from 0.0 to 15.0. The recorded value was divided by 15, then multiplied by 100 to convert it to the VAS-Global scale, with values ranging from 0 (no disease activity) to 100 (very severe disease). The difference between treatment groups for the change from Baseline was tested using the Wilcoxon rank-sum test.||2.7|-21.3|0.12
72508570|NCT01070550|144548046|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.475|||<|0.0001|TWO_SIDED|95.0|1.26|1.726|||Regression, Logistic|||The statistical analysis is presented for HCV RNA at BL in log10 (IU/mL). The logistic regression analysis for relapse 24 weeks after EOT was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.726|1.260|<0.0001
72508571|NCT01070550|144548046|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.963|||<|0.0001|TWO_SIDED|95.0|0.956|0.97|||Regression, Logistic|||The statistical analysis is presented for treatment duration after VR in weeks. The logistic regression analysis for relapse 24 weeks after EOT was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.970|0.956|<0.0001
72508572|NCT01070550|144548046|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.195|||<|0.0001|TWO_SIDED|95.0|1.12|1.275|||Regression, Logistic|||The statistical analysis is presented for cumulative PEG-IFN alfa-2a dose per 1000 ug. The logistic regression analysis for relapse 24 weeks after EOT was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.275|1.120|<0.0001
72508573|NCT01070550|144548046|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.567||||0.0316|TWO_SIDED|95.0|1.04|2.359|||Regression, Logistic|||The statistical analysis is presented for age per 10 years. The logistic regression analysis for relapse 24 weeks after EOT was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||2.359|1.040|0.0316
72508574|NCT01070550|144548046|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.495||||0.0024|TWO_SIDED|95.0|1.701|11.879|||Regression, Logistic|||The statistical analysis is presented for sex (male vs female). The logistic regression analysis for relapse 24 Weeks after EOT was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||11.879|1.701|0.0024
72623301|NCT01979185|144777356|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|If the 90% CI of the geometric mean ratios fell within the range (0.80, 1.25), then equivalence was assumed and the hypothesis that a drug interaction occurred was rejected. If the 90% CIs were not wholly contained within the range (0.80, 1.25), then a drug interaction was not excluded.|Ratio of Geometric LS Means|0.63|||||TWO_SIDED|90.0|0.543|0.73|||Mixed-effects Model|||The means of the log-transformed pharmacokinetic parameters were compared between treatments using a mixed-effects model with period and treatment as fixed effects, and subject nested within sequence as a random effect. In order to estimate the magnitude of the treatment regimen differences in pharmacokinetic parameters, the geometric mean ratio (i.e., the least squares mean difference in the log-transformed parameters back transformed to the original scale) and their 90% CIs were calculated.||0.730|0.543|
72477026|NCT00775463|144479871|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehmann Estimate of Treatment Eff|-9.3||||0.04|TWO_SIDED|95.0|-18.0|0.0||Analyses of secondary endpoints were descriptive in nature, no adjustments for multiplicity were made. P-values are for the purpose of describing the random imbalance between treatment groups and not to test formal hypotheses.|Wilcoxon (Mann-Whitney)|||The VAS-global assessments were recorded in centimeters, with possible values ranging from 0.0 to 15.0. The recorded value was divided by 15, then multiplied by 100 to convert it to the VAS-Global scale, with values ranging from 0 (no disease activity) to 100 (very severe disease). The difference between treatment groups for the change from Baseline was tested using the Wilcoxon rank-sum test.||0.0|-18.0|0.04
72477027|NCT00775463|144479872|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehmann Estimate of Treatment Eff|-1.0||||0.47|TWO_SIDED|95.0|-4.0|2.0||Analyses of secondary endpoints were descriptive in nature, no adjustments for multiplicity were made. P-values are for the purpose of describing the random imbalance between treatment groups and not to test formal hypotheses.|Wilcoxon (Mann-Whitney)|||The difference between treatment groups for the change from Baseline in CHFS Score were tested using the Wilcoxon rank-sum test.||2.0|-4.0|0.47
72477028|NCT00775463|144479874|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehmann Estimate of Treatment Eff|0.0||||0.68|TWO_SIDED|95.0|0.0|1.0|||Wilcoxon (Mann-Whitney)|||he difference between treatment groups for the change from Baseline and at Week 20 in the mRSS was tested using the Wilcoxon rank-sum test.||1.0|0.0|0.68
72477029|NCT00775463|144479875|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehmann Estimate of Treatment Eff|-1.0||||0.54|TWO_SIDED|95.0|-3.0|2.0||P value for Total Pain Rating Index Score|Wilcoxon (Mann-Whitney)|||P value for Total Pain Rating Index Score||2.0|-3.0|0.54
72508575|NCT01070550|144548046|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.112||||0.0247|TWO_SIDED|95.0|1.014|1.219|||Regression, Logistic|||The statistical analysis is presented for BMI in kg/m\^2. The logistic regression analysis for relapse 24 weeks after EOT was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.219|1.014|0.0247
72477030|NCT00775463|144479875|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehmann Estimate of Treatment Ef|-0.6||||0.18|TWO_SIDED|95.0|-1.6|0.3||P value for Pain VAS|Wilcoxon (Mann-Whitney)|||P value for Pain VAS||0.3|-1.6|0.18
72477031|NCT00775463|144479875|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehmann Estimate of Treatment Eff|0.0||||0.1|TWO_SIDED|95.0|-1.0|0.0||P value for Total Pain Rating Index Score|Wilcoxon (Mann-Whitney)|||P value for Total Pain Rating Index Score||0.0|-1.0|0.10
72477032|NCT00969709|144479880|SUPERIORITY_OR_OTHER||Least squares mean difference|-3.23||||0.0186|TWO_SIDED|95.0|-5.92|-0.54|||Mixed Models Analysis|Mixed-effects model for repeated measures.||||-0.54|-5.92|0.0186
72477033|NCT00969709|144479880|SUPERIORITY_OR_OTHER||Least squares mean difference|-3.99||||0.0038|TWO_SIDED|95.0|-6.69|-1.29|||Mixed Models Analysis|Mixed-effects model for repeated measures.||||-1.29|-6.69|0.0038
72477034|NCT00969709|144479880|SUPERIORITY_OR_OTHER||Least squares mean difference|-4.86||||0.0005|TWO_SIDED|95.0|-7.59|-2.12|||Mixed Models Analysis|Mixed-effects model for repeated measures.||||-2.12|-7.59|0.0005
72399619|NCT01975909|144306374|EQUIVALENCE|We hypothesized that the real TMS would improve the performance of 9-hole peg test (i.e., greater percent decrease of time to complete the test from baseline) as compared to the sham TMS.||||||0.12|||||||t-test, 2 sided|||||||0.12
72477035|NCT00969709|144479881|SUPERIORITY_OR_OTHER||Least squares mean difference|-1.41||||0.1687|TWO_SIDED|95.0|-3.42|0.6|||Mixed Models Analysis|Mixed-effects model for repeated measures.||||0.60|-3.42|0.1687
72477036|NCT00969709|144479881|SUPERIORITY_OR_OTHER||least squares mean difference|-2.51||||0.0151|TWO_SIDED|95.0|-4.54|-0.49|||Mixed Models Analysis|Mixed-effects model for repeated measures.||||-0.49|-4.54|0.0151
72477037|NCT00969709|144479881|SUPERIORITY_OR_OTHER||Least squares mean difference|-2.57||||0.0141|TWO_SIDED|95.0|-4.62|-0.52|||Mixed Models Analysis|Mixed-effects model for repeated measures.||||-0.52|-4.62|0.0141
72477038|NCT00266227|144479896|SUPERIORITY_OR_OTHER|||||||0.0195|||||||Cochran-Mantel-Haenszel|||||||0.0195
72477039|NCT00266227|144479898|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4||||||95.0|-0.7|-0.1|||ANOVA|Adjusted mean for Arm A (Rituxan) is -1.9 and adjusted mean for Arm B (Placebo) is -1.5.||Assessed using an analysis of variance (ANOVA) model, with retreatment group, baseline DAS28-ESR score, baseline RF status, and ≥20% improvement in both SJC and TJC at Week 24 from baseline (yes/no) as explanatory terms in the model.||-0.1|-0.7|
72477040|NCT00852540|144479934|SUPERIORITY_OR_OTHER||percentage of participants|56.9|||||TWO_SIDED|95.0|45.5|68.4|||||The estimated value is the percentage of participants achieving clinical response. Confidence intervals are not adjusted for multiplicity.|||68.4|45.5|
72508576|NCT01070550|144548046|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.844||||0.0258|TWO_SIDED|95.0|1.077|3.158|||Regression, Logistic|||The statistical analysis is presented for HCV RNA at BL in log10 (IU/mL). The logistic regression analysis for relapse 24 weeks after EOT was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||3.158|1.077|0.0258
72508577|NCT01070550|144548046|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.66||||0.0009|TWO_SIDED|95.0|1.232|2.235|||Regression, Logistic|||The statistical analysis is presented for age per 10 years. The logistic regression analysis for relapse 24 weeks after EOT was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||2.235|1.232|0.0009
72508578|NCT01070550|144548046|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.255||||0.0045|TWO_SIDED|95.0|1.073|1.467|||Regression, Logistic|||The statistical analysis is presented for weight per 10 kg. The logistic regression analysis for relapse 24 weeks after EOT was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.467|1.073|0.0045
72508579|NCT01070550|144548046|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.086||||0.0001|TWO_SIDED|95.0|1.434|3.034|||Regression, Logistic|||The statistical analysis is presented for HCV RNA at BL in log10 (IU/mL). The logistic regression analysis for relapse 24 weeks after EOT was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||3.034|1.434|0.0001
72508580|NCT01070550|144548046|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.318||||0.001|TWO_SIDED|95.0|0.16|0.63|||Regression, Logistic|||The statistical analysis is presented for liver fibrosis (no cirrhosis vs cirrhosis). The logistic regression analysis for relapse 24 weeks after EOT was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.630|0.160|0.0010
72508581|NCT01070550|144548046|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.275||||0.0021|TWO_SIDED|95.0|0.121|0.626|||Regression, Logistic|||The statistical analysis is presented for liver fibrosis (not assessed/missing vs cirrhosis). The logistic regression analysis for relapse 24 weeks after EOT was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.626|0.121|0.0021
72508582|NCT01070550|144548046|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.962||||0.0064|TWO_SIDED|95.0|0.935|0.989|||Regression, Logistic|||The statistical analysis is presented for treatment duration after VR in weeks. The logistic regression analysis for relapse 24 weeks after EOT was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.989|0.935|0.0064
72508583|NCT01070550|144548046|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.391|||<|0.0001|TWO_SIDED|95.0|1.245|1.553|||Regression, Logistic|||The statistical analysis is presented for age per 10 years. The logistic regression analysis for relapse 24 weeks after EOT was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.553|1.245|<0.0001
72508584|NCT01070550|144548046|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.295||||0.0029|TWO_SIDED|95.0|1.092|1.535|||Regression, Logistic|||The statistical analysis is presented for HCV RNA at BL in log10(IU/mL). The logistic regression analysis for relapse 24 weeks after EOT was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.535|1.092|0.0029
72508585|NCT01070550|144548046|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.109|||<|0.0001|TWO_SIDED|95.0|0.05|0.236|||Regression, Logistic|||The statistical analysis is presented for On-treatment response (RVR vs no RVR/EVR). The logistic regression analysis for relapse 24 weeks after EOT was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.236|0.050|<0.0001
72508586|NCT01070550|144548046|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.32||||0.0014|TWO_SIDED|95.0|0.159|0.645|||Regression, Logistic|||The statistical analysis is presented for on-treatment response (cEVR vs no RVR/EVR). The logistic regression analysis for relapse 24 weeks after EOT was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.645|0.159|0.0014
72508587|NCT01070550|144548046|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.248||||0.539|TWO_SIDED|95.0|0.616|2.528|||Regression, Logistic|||The statistical analysis is presented for on-treatment response (pEVR vs no RVR/EVR). The logistic regression analysis for relapse 24 weeks after EOT was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||2.528|0.616|0.5390
72566364|NCT02697773|144663265|SUPERIORITY||Odds Ratio (OR)|1.56||||0.1351|TWO_SIDED|95.0|0.87|2.79|||Regression, Logistic|||Week 16, \>=90%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.79|0.87|0.1351
72566365|NCT02697773|144663265|SUPERIORITY|The two comparisons for 'Participants with ≥50% reduction from baseline in WOMAC Pain at Week 16' (tanezumab 2.5 mg treatment group versus placebo and tanezumab 2.5/5 mg treatment group versus placebo) were adjusted for multiple comparisons using the Hochberg procedure and an overall significance level of 0.05.|Odds Ratio (OR)|2.17|||<|0.0001|TWO_SIDED|95.0|1.48|3.16|||Regression, Logistic|||Week 16 \>=50%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.16|1.48|<.0001
72566366|NCT02697773|144663267|SUPERIORITY||Odds Ratio (OR)|2.12||||0.0001|TWO_SIDED|95.0|1.45|3.11|||Regression, Logistic|||Week 2, \>=30%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.11|1.45|0.0001
72566367|NCT02697773|144663267|SUPERIORITY||Odds Ratio (OR)|2.32|||<|0.0001|TWO_SIDED|95.0|1.59|3.4|||Regression, Logistic|||Week 2, \>=30%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.40|1.59|<.0001
72566368|NCT02697773|144663267|SUPERIORITY||Odds Ratio (OR)|1.58||||0.0312|TWO_SIDED|95.0|1.04|2.39|||Regression, Logistic|||Week 2, \>=50%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.39|1.04|0.0312
72623302|NCT01979185|144777357|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|If the 90% CI of the geometric mean ratios fell within the range (0.80, 1.25), then equivalence was assumed and the hypothesis that a drug interaction occurred was rejected. If the 90% CIs were not wholly contained within the range (0.80, 1.25), then a drug interaction was not excluded.|Ratio of Geometric LS Means|0.594|||||TWO_SIDED|90.0|0.526|0.672|||Mixed-effects Model|||The means of the log-transformed pharmacokinetic parameters were compared between treatments using a mixed-effects model with period and treatment as fixed effects, and subject nested within sequence as a random effect. In order to estimate the magnitude of the treatment regimen differences in pharmacokinetic parameters, the geometric mean ratio (i.e., the least squares mean difference in the log-transformed parameters back transformed to the original scale) and their 90% CIs were calculated.||0.672|0.526|
72623303|NCT00980798|144777358|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.2365||||0.1212|TWO_SIDED|95.0|-0.5357|0.0627||No adjustment for multiple comparisons necessary, as only 1 primary hypothesis was tested. Threshold for statistical significance was 0.05.|Mixed-model regression analysis|The difference above is presented as the difference OROS hydromorphone HCl minus placebo, so negative scores favour OROS hydromorphone HCl.|The analysis was adjusted for baseline BPI item 5 score, time on study, and whether the primary affected joint was the hip or knee.|The F test for treatment tested the null hypothesis of no treatment difference. Assuming that 3 baseline measures and 7 post baseline measures were collected 81 patients were required per group to detect a difference of 1 point in the BPI measure with 90% power at a significance level of 5%. To allow for a drop-out rate of approximately 40%, the study planned to recruit 135 patients per group (i.e. 270 in total).||0.0627|-0.5357|0.1212
72623304|NCT04724837|144777360|SUPERIORITY|Two-sided p-value is presented. A p-value \<0.10 indicates statistical significance, which is consistent with a one-sided test at the 5% level.|Adjusted % mean change from baseline|-33.7|||<|0.001|TWO_SIDED|90.0|-42.5|-23.5|||Mixed Models Analysis||If adjusted percentage mean change from baseline \>0 then the result favours Dapa 10 mg + PBO for UACR.|Comparison between Zibotentan 1.5 mg + Dapagliflozin and Dapagliflozin 10 mg + Placebo (PBO)||-23.5|-42.5|<0.001
72623305|NCT04724837|144777361|SUPERIORITY|Two-sided p-value is presented. A p-value \<0.10 indicates statistical significance, which is consistent with a one-sided test at the 5% level.|Adjusted % mean change from baseline|-27.0||||0.002|TWO_SIDED|90.0|-38.4|-13.6|||Mixed Models Analysis||If adjusted percentage mean change from baseline \>0 then the result favours Dapa 10 mg + PBO for UACR.|Comparison between Zibotentan 0.25 mg + Dapagliflozin and Dapagliflozin 10 mg + PBO||-13.6|-38.4|0.002
72623306|NCT04724837|144777362|SUPERIORITY||Least Square (LS) mean CFB|-3.6|||||TWO_SIDED|90.0|-6.8|-0.5|||Mixed Models Analysis||If mean change from baseline (CFB) \>0 then the result favours Dapa 10 mg + PBO for office systolic blood pressure.|Comparison between Zibotentan 0.25 mg + Dapagliflozin and Dapagliflozin 10 mg + PBO||-0.5|-6.8|
72623307|NCT04724837|144777362|SUPERIORITY||LS mean CFB|-7.6|||||TWO_SIDED|90.0|-10.3|-4.9|||Mixed Models Analysis||If mean change from baseline \>0 then the result favours Dapa 10 mg + PBO for office systolic blood pressure.|Comparison between Zibotentan 1.5 mg + Dapagliflozin and Dapagliflozin 10 mg + PBO||-4.9|-10.3|
72623308|NCT04724837|144777363|SUPERIORITY||LS Mean CFB|-3.0|||||TWO_SIDED|90.0|-5.0|-1.0|||Mixed Models Analysis||If mean change from baseline \>0 then the result favours Dapa 10 mg + PBO for office diastolic blood pressure.|Comparison between Zibotentan 0.25 mg + Dapagliflozin and Dapagliflozin 10 mg + PBO||-1.0|-5.0|
72623309|NCT04724837|144777363|SUPERIORITY||LS Mean CFB|-5.4|||||TWO_SIDED|90.0|-7.1|-3.7|||Mixed Models Analysis||If mean change from baseline \>0 then the result favours Dapa 10 mg + PBO for office diastolic blood pressure.|Comparison between Zibotentan 1.5 mg + Dapagliflozin and Dapagliflozin 10 mg + PBO||-3.7|-7.1|
72623310|NCT04724837|144777364|SUPERIORITY||Adjusted % mean change from baseline|-27.0|||||TWO_SIDED|90.0|-38.4|-13.6|||Mixed Models Analysis||If adjusted percentage mean change from baseline \>0 then the result favours Dapa 10 mg + PBO for UACR.|Comparison between Zibotentan 0.25 mg + Dapagliflozin and Dapagliflozin 10 mg + PBO||-13.6|-38.4|
72623311|NCT04724837|144777364|SUPERIORITY||Adjusted % mean change from baseline|-33.7|||||TWO_SIDED|90.0|-42.5|-23.5|||Mixed Models Analysis||If adjusted percentage mean change from baseline \>0 then the result favours Dapa 10 mg + PBO for UACR.|Comparison between Zibotentan 1.5 mg + Dapagliflozin and Dapagliflozin 10 mg + PBO||-23.5|-42.5|
72623312|NCT04724837|144777365|SUPERIORITY||LS mean CFB|1.1|||||TWO_SIDED|90.0|-0.5|2.6|||Mixed Models Analysis||If mean change from baseline \<0 then the result favours Dapa 10 mg + PBO for eGFR.|Week 1 - Comparison between Zibotentan 0.25 mg + Dapagliflozin and Dapagliflozin 10 mg + PBO||2.6|-0.5|
72623313|NCT04724837|144777365|SUPERIORITY||LS mean CFB|-0.8|||||TWO_SIDED|90.0|-2.1|0.5|||Mixed Models Analysis||If mean change from baseline \<0 then the result favours Dapa 10 mg + PBO for eGFR.|Week 1 - Comparison between Zibotentan 1.5 mg + Dapagliflozin and Dapagliflozin 10 mg + PBO||0.5|-2.1|
72477041|NCT00852540|144479934|SUPERIORITY_OR_OTHER||Percentage of participants|84.2|||||TWO_SIDED|95.0|72.6|95.8|||||The estimated value is the percentage of participants achieving clinical response. Confidence intervals are not adjusted for multiplicity.|||95.8|72.6|
72477042|NCT01639495|144479947|SUPERIORITY_OR_OTHER||Percentage of subjects|60.6|||||TWO_SIDED|95.0|51.9|68.8|||||The 2-sided 95% confidence intervals are based on exact binomial|||68.8|51.9|
72623314|NCT04724837|144777365|SUPERIORITY||LS mean CFB|-1.2|||||TWO_SIDED|90.0|-2.8|0.5|||Mixed Models Analysis||If mean change from baseline \<0 then the result favours Dapa 10 mg + PBO for eGFR.|Week 12 - Comparison between Zibotentan 0.25 mg + Dapagliflozin and Dapagliflozin 10 mg + PBO||0.5|-2.8|
72623315|NCT04724837|144777365|SUPERIORITY||LS mean CFB|-1.1|||||TWO_SIDED|90.0|-2.5|0.3|||Mixed Models Analysis||If mean change from baseline \<0 then the result favours Dapa 10 mg + PBO for eGFR.|Week 12 - Comparison between Zibotentan 1.5 mg + Dapagliflozin and Dapagliflozin 10 mg + PBO||0.3|-2.5|
72508588|NCT01070550|144548046|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.604||||0.0223|TWO_SIDED|95.0|1.069|2.405|||Regression, Logistic|||The statistical analysis is presented for age per 10 years. The logistic regression analysis for relapse 24 weeks after EOT was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||2.405|1.069|0.0223
72477043|NCT01639495|144479949|SUPERIORITY_OR_OTHER||Percentage of subjects with primary AEs|17.4|||||TWO_SIDED|95.0|11.6|24.6|||||The 2-sided 95% confidence interval is exact binomial|||24.6|11.6|
72477044|NCT01639495|144479950|SUPERIORITY_OR_OTHER||Percentage of subjects|97.2|||||TWO_SIDED|95.0|95.6|98.2|||||The 2-sided 95% confidence intervals are exact binomial|||98.2|95.6|
72399620|NCT01975909|144306375|EQUIVALENCE|We hypothesized that the real TMS would improve the performance of 90-second walking test (i.e., greater percent increase of walking speed from baseline) as compared to the sham TMS.||||||0.69|||||||t-test, 2 sided|||||||0.69
72399621|NCT01975909|144306376|EQUIVALENCE|We hypothesized that the real TMS would improve the standing postural control stability (i.e., greater percent decrease increase of postural sway speed from baseline) as compared to the sham TMS.||||||0.009|||||||t-test, 2 sided|||||||0.009
72399622|NCT01975909|144306377|EQUIVALENCE|We hypothesized that the real TMS would improve the performance of TUG test (i.e., greater percent decrease of time to complete TUG test from baseline) as compared to the sham TMS.||||||0.18|||||||t-test, 2 sided|||||||0.18
72399623|NCT05027438|144306464|SUPERIORITY||Mean Difference (Net)|-7.58|STANDARD_DEVIATION|5.19|<|0.001|TWO_SIDED||||||Mixed Models Analysis||post-treatment - baseline (negative value indicates reduction of symptoms)|baseline to post-treatment|effect size (f2) = 1.42 (large \>=0.35)|||<0.001
72399624|NCT05027438|144306464|SUPERIORITY||Mean Difference (Net)|-7.06|STANDARD_DEVIATION|4.4|<|0.001|TWO_SIDED||||||Mixed Models Analysis||3-month follow-up - baseline (negative value indicates reduction of symptoms)|baseline to 3-month follow-up|effect size (f2) = 1.54 (large \>=0.35)|||<0.001
72399625|NCT05027438|144306465|SUPERIORITY||Mean Difference (Net)|58.55|STANDARD_DEVIATION|43.98||0.004|TWO_SIDED|||||Bonferroni correction|Friedman test|||% change in medication dose from baseline to post-treatment||||0.004
72399626|NCT05027438|144306465|SUPERIORITY||Mean Difference (Net)|62.26|STANDARD_DEVIATION|54.93||0.005|TWO_SIDED|||||Bonferroni correction|Friedman test|||% change in medication dose from baseline to 3-month follow-up||||0.005
72399627|NCT05027438|144306466|SUPERIORITY||Proportion (%)|31.8||||0.052|TWO_SIDED||||||Cochran's Q test|Bonferroni correction||baseline to post-treatment||||0.052
72508589|NCT01070550|144548046|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.444||||0.0056|TWO_SIDED|95.0|1.547|12.766|||Regression, Logistic|||The statistical analysis is presented for sex (male vs female). The logistic regression analysis for relapse 24 weeks after EOT was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||12.766|1.547|0.0056
72508590|NCT01070550|144548046|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.403||||0.0267|TWO_SIDED|95.0|1.04|1.892|||Regression, Logistic|||The statistical analysis is presented for weight per 10 kg. The logistic regression analysis for relapse 24 weeks after EOT was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.892|1.040|0.0267
72623316|NCT04724837|144777365|SUPERIORITY||LS mean CFB|0.1|||||TWO_SIDED|90.0|-1.6|1.8|||Mixed Models Analysis||If mean change from baseline \<0 then the result favours Dapa 10 mg + PBO for eGFR.|Week 14 - Comparison between Zibotentan 0.25 mg + Dapagliflozin and Dapagliflozin 10 mg + PBO||1.8|-1.6|
72399628|NCT05027438|144306466|SUPERIORITY||Proportion (%)|60.0|||<|0.001|TWO_SIDED||||||Cochran's Q test|Bonferroni correction||baseline to 3-month follow-up||||<0.001
72399629|NCT05027438|144306467|SUPERIORITY||Mean Difference (Net)|-16.67|STANDARD_DEVIATION|20.57|<|0.001|TWO_SIDED||||||Mixed Models Analysis||post-treatment - baseline (negative value indicates reduction of symptoms)|baseline to post-treatment|effect size (f2) = 0.54 (large \>=0.35)|||<0.001
72623317|NCT04724837|144777365|SUPERIORITY||LS mean CFB|-2.1|||||TWO_SIDED|90.0|-3.5|-0.7|||Mixed Models Analysis||If mean change from baseline \<0 then the result favours Dapa 10 mg + PBO for eGFR.|Week 14 - Comparison between Zibotentan 1.5 mg + Dapagliflozin and Dapagliflozin 10 mg + PBO||-0.7|-3.5|
72623318|NCT04724837|144777367|SUPERIORITY||LS mean change|-2.2|||||TWO_SIDED|90.0|-4.0|-0.4|||Mixed Models Analysis||If mean change \<0 then the result favours Dapa 10 mg + PBO for eGFR.|Week 1 and Week 12 - Comparison between Zibotentan 0.25 mg + Dapagliflozin and Dapagliflozin 10 mg + PBO||-0.4|-4.0|
72399630|NCT05027438|144306467|SUPERIORITY||Mean Difference (Net)|-17.11|STANDARD_DEVIATION|22.11|<|0.001|TWO_SIDED||||||Mixed Models Analysis||3-month follow-up - baseline (negative value indicates reduction of symptoms)|baseline to 3-month follow-up|effect size (f2) = 0.47 (large \>=0.35)|||<0.001
72399631|NCT05027438|144306468|SUPERIORITY||Mean Difference (Net)|-6.24|STANDARD_DEVIATION|20.34||0.101|TWO_SIDED||||||Mixed Models Analysis||post-treatment - baseline (negative value indicates reduction of symptoms)|baseline to post-treatment|effect size (f2) = 0.10 (small \>=0.02)|||0.101
72399632|NCT05027438|144306468|SUPERIORITY||Mean Difference (Net)|-10.34|STANDARD_DEVIATION|18.28|<|0.001|TWO_SIDED||||||Mixed Models Analysis||3-month follow-up - baseline (negative value indicates reduction of symptoms)|baseline to 3-month follow-up|effect size (f2) = 0.34 (medium; large \>=0.35)|||<0.001
72399633|NCT05027438|144306469|SUPERIORITY||Mean Difference (Net)|5.0|STANDARD_DEVIATION|6.0|<|0.001|TWO_SIDED||||||Mixed Models Analysis||post-treatment - baseline (positive value indicates improvement)|baseline to post-treatment|effect size (f2) = 0.87 (large \>=0.35)|||<0.001
72399634|NCT05027438|144306469|SUPERIORITY||Mean Difference (Net)|6.0|STANDARD_DEVIATION|6.0|<|0.001|TWO_SIDED||||||Mixed Models Analysis||3-month follow-up - baseline (positive value indicates improvement)|baseline to 3-month follow-up|effect size (f2) = 0.96 (large \>=0.35)|||<0.001
72399635|NCT05027438|144306470|SUPERIORITY||Mean Difference (Net)|-7.48|STANDARD_DEVIATION|6.08|<|0.001|TWO_SIDED||||||Mixed Models Analysis||post-treatment - baseline (negative value indicates improvement)|Sleep Disturbance - higher scores indicate more sleep disturbance. The T-score rescales the raw score into a standardized T-score with a mean of 50 and a standard deviation (SD) of 10.|effect size (f2) = 1.14 (large \>=0.35)|||<0.001
72399636|NCT05027438|144306470|SUPERIORITY||Mean Difference (Net)|-7.82|STANDARD_DEVIATION|5.62|<|0.001|TWO_SIDED||||||Mixed Models Analysis||3-month follow-up - baseline (negative value indicates improvement)|Sleep Disturbance - higher scores indicate more sleep disturbance. The T-score rescales the raw score into a standardized T-score with a mean of 50 and a standard deviation (SD) of 10.|effect size (f2) = 1.21 (large \>=0.35)|||<0.001
72399637|NCT05027438|144306471|SUPERIORITY||Mean Difference (Net)|0.11|STANDARD_DEVIATION|0.21||0.22|TWO_SIDED||||||Mixed Models Analysis||post-treatment - baseline (positive value indicates improvement)||effect size (f2) = 0.18 (medium \>=0.15)|||0.22
72399638|NCT05027438|144306471|SUPERIORITY||Mean Difference (Net)|0.2|STANDARD_DEVIATION|0.12|<|0.001|TWO_SIDED||||||Mixed Models Analysis||3-month follow-up - baseline (positive value indicates improvement)||effect size (f2) = 1.99 (large \>=0.35)|||<0.001
72399639|NCT01921179|144306516|EQUIVALENCE|A repeated measures MANOVA was used to compare the impact of GOALS training versus the BHE training on neurocognitive performance Attention and Executive Function Overall Domain Z Score|||||<|0.01|||||||ANOVA|||||||<0.01
72399640|NCT01921179|144306517|EQUIVALENCE|A repeated measure multivariate analysis of variance (MANOVA) was used to compare neurocognitive performance on Overall Attention /Executive Function overall score at baseline and at 6+ month post-GOALS training follow-up|||||<|0.001|||||||ANOVA|Repeated measure MANOVA was used to compare performance on neurocognitive domain scores at baseline and at 6+ month follow-up post-GOALS training||||||<0.001
72399641|NCT01921179|144306518|EQUIVALENCE|A repeated measures MANOVA was used to compare the impact of GOALS training versus the BHE training on functional performance|||||>|0.05|||||||ANOVA|A repeated measures MANOVA was used to compare the impact of GOALS training versus the BHE training on functional performance||||||>0.05
72399642|NCT01921179|144306519|EQUIVALENCE|A repeated measure multivariate analysis of variance (MANOVA) was used to compare performance on Goal Processing Scale Overall domain scores at baseline and 6+ month post-GOALS training follow-up|||||<|0.001|||||||ANOVA|||||||<0.001
72399643|NCT01921179|144306520|EQUIVALENCE|A repeated measures MANOVA was used to compare the impact of GOALS training versus the BHE training on emotional regulation measures - POMS Total score|||||<|0.05|||||||ANOVA|A repeated measures MANOVA was used to compare the impact of GOALS versus the BHE training on emotional regulation measures - POMS Total score||||||<0.05
72399644|NCT01921179|144306521|EQUIVALENCE|A repeated measure multivariate analysis of variance (MANOVA) was used to compare participants' self-report on POMS Total Mood Disturbance overall score at baseline and 6+ month post-GOALS training follow-up|||||<|0.01|||||||ANOVA|||||||<0.01
72399645|NCT00858442|144306586|NON_INFERIORITY_OR_EQUIVALENCE|"Applies normality test of shapiro Wilks = 0.953, P\> 0.449 in group without PRP and in PRP group shapiro Wilks=0.946, P \> 0.259.~The data were normally distributed, with equal variances (Test of levene: F = 0.1234, P\> 0.99)"|Mean Difference (Final Values)|-2.452|STANDARD_ERROR_OF_MEAN|2.452|>|0.1574|TWO_SIDED|95.0|-7.332|2.428||Applies t-test for equality of means. t = -1.016 is obtained. p\> 0.1574|t-test, 1 sided|||||2.428|-7.332|>0.1574
72399646|NCT00858442|144306587|NON_INFERIORITY_OR_EQUIVALENCE|"Applies normality test of shapiro Wilks =0.972, P\> 0.687 in group without PRP and in PRP group shapiro Wilks = 0.964, P \> 0.410.~The data were normally distributed, with equal variances (Test of levene: F = 3.153, P\> 0.082)"|Mean Difference (Final Values)|-0.27186|STANDARD_ERROR_OF_MEAN|0.50519|>|0.593|TWO_SIDED|95.0|-1.28561|0.74189||Applies t-test for equality of means. t = -0.538 is obtained. p\> 0.593|t-test, 2 sided|||||0.74189|-1.28561|>0.593
72477045|NCT00618618|144479961|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.6||||0.005|TWO_SIDED|95.0|-1.0|-0.2|||ANCOVA|Based on an analysis of covariance (ANCOVA) model with treatment as the main effect and baseline SMF Rating Scale score as a covariate.||||-0.2|-1.0|0.005
72477046|NCT00618618|144479961|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.9||||0.001|TWO_SIDED|95.0|-1.4|-0.4|||ANCOVA|Based on an ANCOVA model with treatment as the main effect and baseline SMF Rating Scale score as a covariate.||||-0.4|-1.4|0.001
72477047|NCT00618618|144479961|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4||||0.069|TWO_SIDED|95.0|-0.8|0.0|||ANCOVA|Based on an ANCOVA model with treatment as the main effect and baseline SMF Rating Scale score as a covariate.||||0.0|-0.8|0.069
72477048|NCT00618618|144479962|SUPERIORITY_OR_OTHER||LS Mean Difference|1.8||||0.005|TWO_SIDED|95.0|0.6|3.0|||ANCOVA|Based on an ANCOVA model with treatment as the main effect and baseline SMF Rating Scale score as a covariate.||||3.0|0.6|0.005
72477049|NCT00618618|144479962|SUPERIORITY_OR_OTHER||LS Mean Difference|2.5||||0.001|TWO_SIDED|95.0|1.0|4.0|||ANCOVA|Based on an ANCOVA model with treatment as the main effect and baseline SMF Rating Scale score as a covariate.||||4.0|1.0|0.001
72477050|NCT00618618|144479962|SUPERIORITY_OR_OTHER||LS Mean Difference|1.0||||0.122|TWO_SIDED|95.0|-0.3|2.2|||ANCOVA|Based on an ANCOVA model with treatment as the main effect and baseline SMF Rating Scale score as a covariate.||||2.2|-0.3|0.122
72477051|NCT00618618|144479963|SUPERIORITY_OR_OTHER||Difference from Placebo|38.3||||0.008|TWO_SIDED|95.0|11.0|65.7|||Fisher Exact|||||65.7|11.0|0.008
72508591|NCT01070550|144548046|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.226||||0.0018|TWO_SIDED|95.0|0.089|0.575|||Regression, Logistic|||The statistical analysis is presented for on-treatment response, combined (RVR vs no RVR). The logistic regression analysis for relapse 24 weeks after EOT was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.575|0.089|0.0018
72623319|NCT04724837|144777367|SUPERIORITY||LS mean change|-0.3|||||TWO_SIDED|90.0|-1.8|1.3|||Mixed Models Analysis||If mean change \<0 then the result favours Dapa 10 mg + PBO for eGFR.|Week 1 and 12 - Comparison between Zibotentan 1.5 mg + Dapagliflozin and Dapagliflozin 10 mg + PBO||1.3|-1.8|
72623320|NCT00967499|144777397|SUPERIORITY|||||||0.401|||||||Cochran-Mantel-Haenszel|||||||0.4010
72399647|NCT00858442|144306588|NON_INFERIORITY_OR_EQUIVALENCE|"Applies normality test of shapiro Wilks=0.822, P\<0.001 in group without PRP, and in PRP group shapiro Wilks =0.910, P\<0.017.~The data were no normally distributed, with equal variances (Test of levene, F=1.324, P\>0.255)"|||||>|0.398|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|Mean rank group without PRP= 28.88 Mean rank group with PRP= 26.31 Z value = -0.027||||||>0.398
72477052|NCT00618618|144479963|SUPERIORITY_OR_OTHER||Difference from Placebo|32.9||||0.172|TWO_SIDED|95.0|1.0|64.8|||Fisher Exact|||||64.8|1.0|0.172
72477053|NCT00618618|144479963|SUPERIORITY_OR_OTHER||Difference from Placebo|22.9||||0.252|TWO_SIDED|95.0|-8.4|54.2|||Fisher Exact|||||54.2|-8.4|0.252
72477054|NCT00618618|144479964|SUPERIORITY_OR_OTHER||Difference from Placebo|46.1||||0.011|TWO_SIDED|95.0|16.3|75.9|||Fisher Exact|||||75.9|16.3|0.011
72477055|NCT00618618|144479964|SUPERIORITY_OR_OTHER||Difference from Placebo|54.3||||0.013|TWO_SIDED|95.0|23.0|85.5|||Fisher Exact|||||85.5|23.0|0.013
72477056|NCT00618618|144479964|SUPERIORITY_OR_OTHER||Difference from Placebo|24.3||||0.296|TWO_SIDED|95.0|-8.7|57.3|||Fisher Exact|||||57.3|-8.7|0.296
72477057|NCT00618618|144479965|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1||||0.46|TWO_SIDED|95.0|-0.5|0.2|||Repeated Measures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 4||0.2|-0.5|0.460
72477058|NCT00618618|144479965|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0||||0.906|TWO_SIDED|95.0|-0.5|0.4|||Repeated Measures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 4||0.4|-0.5|0.906
72477059|NCT00618618|144479965|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2||||0.404|TWO_SIDED|95.0|-0.6|0.2|||Repeated Measures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 4||0.2|-0.6|0.404
72623321|NCT00967499|144777398|SUPERIORITY|||||||0.5672|||||||Cochran-Mantel-Haenszel|||||||0.5672
72623322|NCT00967499|144777399|SUPERIORITY|||||||0.057|||||||Cochran-Mantel-Haenszel|||||||0.0570
72623323|NCT00967499|144777400|SUPERIORITY|||||||0.515|||||||Cochran-Mantel-Haenszel|||||||0.5150
72623324|NCT00967499|144777401|SUPERIORITY|||||||0.3601||||||P-values are based on Cochran-Mantel-Haenszel row mean score test with gender adjustment for the ranks of the change from baseline values.|Cochran-Mantel-Haenszel|||||||0.3601
72623325|NCT00967499|144777402|SUPERIORITY|||||||0.3453|||||||Mann-Whitney Test|||24 hours postdose||||0.3453
72623326|NCT00967499|144777402|SUPERIORITY|||||||0.7874|||||||Mann-Whitney Test|||48 hours postdose||||0.7874
72623327|NCT00967499|144777402|SUPERIORITY|||||||0.8485|||||||Mann-Whitney Test|||72 Hours Postdose||||0.8485
72623328|NCT04562090|144777416|SUPERIORITY|Statistical testing was conducted using 2-sided at a significance level of 0.05.|LS Mean|-3.73|STANDARD_ERROR_OF_MEAN|0.29|<|0.001|TWO_SIDED|95.0|-4.3|-3.16||Repeated Measures Analysis (RMA): CFB as response, treatment group (TG), visit (week 4, 8 and 12), pooled site, sex and the interaction between TG and visit as fixed effects and mean number of micturitions per 24 hours at baseline as covariate.|MMRM|||Week 12||-3.16|-4.30|<0.001
72623329|NCT04562090|144777419|SUPERIORITY|Statistical testing was conducted using 2-sided at a significance level of 0.05.|LS Mean|-2.62|STANDARD_ERROR_OF_MEAN|0.32|<|0.001|TWO_SIDED|95.0|-3.25|-1.99||RMA: CFB as response, TG, visit (week 4, 8 and 12), pooled site, sex and interaction between TG and visit as fixed effects and mean (SD) number of grade 3 or 4 (PPIUS) urgency episodes per 24 hours at baseline as covariate.|MMRM|||Week 4||-1.99|-3.25|<0.001
72623330|NCT04562090|144777419|SUPERIORITY|Statistical testing was conducted using 2-sided at a significance level of 0.05.|LS Mean|-2.47|STANDARD_ERROR_OF_MEAN|0.23|<|0.001|TWO_SIDED|95.0|-2.93|-2.02||RMA: CFB as response, TG, visit (week 4, 8 and 12), pooled site, sex and interaction between TG and visit as fixed effects and mean (SD) number of grade 3 or 4 (PPIUS) urgency episodes per 24 hours at baseline as covariate.|MMRM|||Week 4||-2.02|-2.93|<0.001
72623331|NCT04562090|144777419|SUPERIORITY|Statistical testing was conducted using 2-sided at a significance level of 0.05.|LS Mean|-3.13|STANDARD_ERROR_OF_MEAN|0.42|<|0.001|TWO_SIDED|95.0|-3.96|-2.3||RMA: CFB as response, TG, visit (week 4, 8 and 12), pooled site, sex and interaction between TG and visit as fixed effects and mean (SD) number of grade 3 or 4 (PPIUS) urgency episodes per 24 hours at baseline as covariate.|MMRM|||Week 8||-2.30|-3.96|<0.001
72623332|NCT04562090|144777419|SUPERIORITY|Statistical testing was conducted using 2-sided at a significance level of 0.05.|LS Mean|-2.93|STANDARD_ERROR_OF_MEAN|0.23|<|0.001|TWO_SIDED|95.0|-3.39|-2.47||RMA: CFB as response, TG, visit (week 4, 8 and 12), pooled site, sex and interaction between TG and visit as fixed effects and mean (SD) number of grade 3 or 4 (PPIUS) urgency episodes per 24 hours at baseline as covariate.|MMRM|||Week 8||-2.47|-3.39|<0.001
72623333|NCT04562090|144777419|SUPERIORITY|Statistical testing was conducted using 2-sided at a significance level of 0.05.|LS Mean|-3.47|STANDARD_ERROR_OF_MEAN|0.46|<|0.001|TWO_SIDED|95.0|-4.37|-2.56||RMA: CFB as response, TG, visit (week 4, 8 and 12), pooled site, sex and interaction between TG and visit as fixed effects and mean (SD) number of grade 3 or 4 (PPIUS) urgency episodes per 24 hours at baseline as covariate.|MMRM|||Week 12||-2.56|-4.37|<0.001
72623334|NCT04562090|144777419|SUPERIORITY|Statistical testing was conducted using 2-sided at a significance level of 0.05.|LS Mean|-3.59|STANDARD_ERROR_OF_MEAN|0.24|<|0.001|TWO_SIDED|95.0|-4.06|-3.12||RMA: CFB as response, TG, visit (week 4, 8 and 12), pooled site, sex and interaction between TG and visit as fixed effects and mean (SD) number of grade 3 or 4 (PPIUS) urgency episodes per 24 hours at baseline as covariate.|MMRM|||Week 12||-3.12|-4.06|<0.001
72623335|NCT04562090|144777420|SUPERIORITY|Statistical testing was conducted using 2-sided at a significance level of 0.05.|LS Mean|-0.66|STANDARD_ERROR_OF_MEAN|0.11|<|0.001|TWO_SIDED|95.0|-0.88|-0.44||RMA: CFB as response, TG, visit (week 4, 8 and 12), pooled site, sex and the interaction between TG and visit as fixed effects and mean number of daytime incontinence episodes per 24 hours at baseline as covariate.|MMRM|||Week 4||-0.44|-0.88|<0.001
72623336|NCT04562090|144777420|SUPERIORITY|Statistical testing was conducted using 2-sided at a significance level of 0.05.|LS Mean|-0.81|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-0.97|-0.65||RMA: CFB as response, TG, visit (week 4, 8 and 12), pooled site, sex and the interaction between TG and visit as fixed effects and mean number of daytime incontinence episodes per 24 hours at baseline as covariate.|MMRM|||Week 4||-0.65|-0.97|<0.001
72623337|NCT04562090|144777420|SUPERIORITY|Statistical testing was conducted using 2-sided at a significance level of 0.05.|LS Mean|-0.88|STANDARD_ERROR_OF_MEAN|0.15|<|0.001|TWO_SIDED|95.0|-1.17|-0.58||RMA: CFB as response, TG, visit (week 4, 8 and 12), pooled site, sex and the interaction between TG and visit as fixed effects and mean number of daytime incontinence episodes per 24 hours at baseline as covariate.|MMRM|||Week 8||-0.58|-1.17|<0.001
72623338|NCT04562090|144777420|SUPERIORITY|Statistical testing was conducted using 2-sided at a significance level of 0.05.|LS Mean|-0.94|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-1.1|-0.78||RMA: CFB as response, TG, visit (week 4, 8 and 12), pooled site, sex and the interaction between TG and visit as fixed effects and mean number of daytime incontinence episodes per 24 hours at baseline as covariate.|MMRM|||Week 8||-0.78|-1.10|<0.001
72623339|NCT04562090|144777420|SUPERIORITY|Statistical testing was conducted using 2-sided at a significance level of 0.05.|LS Mean|-1.03|STANDARD_ERROR_OF_MEAN|0.16|<|0.001|TWO_SIDED|95.0|-1.35|-0.71||RMA: CFB as response, TG, visit (week 4, 8 and 12), pooled site, sex and the interaction between TG and visit as fixed effects and mean number of daytime incontinence episodes per 24 hours at baseline as covariate.|MMRM|||Week 12||-0.71|-1.35|<0.001
72623340|NCT04562090|144777420|SUPERIORITY|Statistical testing was conducted using 2-sided at a significance level of 0.05.|LS Mean|-0.98|STANDARD_ERROR_OF_MEAN|0.09|<|0.001|TWO_SIDED|95.0|-1.14|-0.81||RMA: CFB as response, TG, visit (week 4, 8 and 12), pooled site, sex and the interaction between TG and visit as fixed effects and mean number of daytime incontinence episodes per 24 hours at baseline as covariate.|MMRM|||Week 12||-0.81|-1.14|<0.001
72623341|NCT04562090|144777421|SUPERIORITY|Statistical testing was conducted using 2-sided at a significance level of 0.05.|LS Mean|-0.48|STANDARD_ERROR_OF_MEAN|0.05|<|0.001|TWO_SIDED|95.0|-0.58|-0.37||RMA: CFB as response, TG, visit (week 4, 8 and 12), pooled site, sex and the interaction between TG and visit as fixed effects and mean number of nighttime incontinence episodes per 24 hours at baseline as covariate.|MMRM|||Week 4||-0.37|-0.58|<0.001
72477060|NCT00618618|144479965|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1||||0.791|TWO_SIDED|95.0|-0.5|0.3|||Repeated Measures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 8||0.3|-0.5|0.791
72477061|NCT00618618|144479965|SUPERIORITY_OR_OTHER||LS Mean Difference|0.2||||0.41|TWO_SIDED|95.0|-0.3|0.6|||Repeated Measures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 8||0.6|-0.3|0.410
72477062|NCT00618618|144479965|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1||||0.733|TWO_SIDED|95.0|-0.3|0.5|||Repeated Measures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 8||0.5|-0.3|0.733
72477063|NCT00618618|144479965|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1||||0.542|TWO_SIDED|95.0|-0.3|0.5|||Repeated Measures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 12||0.5|-0.3|0.542
72477064|NCT00618618|144479965|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0||||0.882|TWO_SIDED|95.0|-0.4|0.5|||Repeated Measures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 12||0.5|-0.4|0.882
72477065|NCT00618618|144479965|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0||||0.934|TWO_SIDED|95.0|-0.4|0.4|||Repeated Measures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 12||0.4|-0.4|0.934
72477066|NCT00618618|144479965|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0||||0.838|TWO_SIDED|95.0|-0.4|0.4|||Repeated Measures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 16||0.4|-0.4|0.838
72623342|NCT04562090|144777421|SUPERIORITY|Statistical testing was conducted using 2-sided at a significance level of 0.05.|LS Mean|-0.46|STANDARD_ERROR_OF_MEAN|0.04|<|0.001|TWO_SIDED|95.0|-0.53|-0.38||RMA: CFB as response, TG, visit (week 4, 8 and 12), pooled site, sex and the interaction between TG and visit as fixed effects and mean number of nighttime incontinence episodes per 24 hours at baseline as covariate.|MMRM|||Week 4||-0.38|-0.53|<0.001
72623343|NCT04562090|144777421|SUPERIORITY|Statistical testing was conducted using 2-sided at a significance level of 0.05.|LS Mean|-0.53|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|95.0|-0.67|-0.39||RMA: CFB as response, TG, visit (week 4, 8 and 12), pooled site, sex and the interaction between TG and visit as fixed effects and mean number of nighttime incontinence episodes per 24 hours at baseline as covariate.|MMRM|||Week 8||-0.39|-0.67|<0.001
72623344|NCT04562090|144777421|SUPERIORITY|Statistical testing was conducted using 2-sided at a significance level of 0.05.|LS Mean|-0.45|STANDARD_ERROR_OF_MEAN|0.04|<|0.001|TWO_SIDED|95.0|-0.52|-0.37||RMA: CFB as response, TG, visit (week 4, 8 and 12), pooled site, sex and the interaction between TG and visit as fixed effects and mean number of nighttime incontinence episodes per 24 hours at baseline as covariate.|MMRM|||Week 8||-0.37|-0.52|<0.001
72623345|NCT04562090|144777421|SUPERIORITY|Statistical testing was conducted using 2-sided at a significance level of 0.05.|LS Mean|-0.53|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-0.68|-0.38||RMA: CFB as response, TG, visit (week 4, 8 and 12), pooled site, sex and the interaction between TG and visit as fixed effects and mean number of nighttime incontinence episodes per 24 hours at baseline as covariate.|MMRM|||Week 12||-0.38|-0.68|<0.001
72399648|NCT01466348|144306634|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|3.6||||0.0008|TWO_SIDED|95.0|1.5|5.6|||ANOVA|No baseline covariate adjustment was carried out.|A positive difference favors the paracetamol/ caffeine treatment.|Null hypothesis was no difference in treatments in the change from baseline in the number of valid responses from the RVIP.||5.6|1.5|0.0008
72477067|NCT00618618|144479965|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1||||0.777|TWO_SIDED|95.0|-0.5|0.4|||Repeated Measures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 16||0.4|-0.5|0.777
72477068|NCT00618618|144479965|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1||||0.795|TWO_SIDED|95.0|-0.4|0.5|||Repeated Measures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 16||0.5|-0.4|0.795
72477069|NCT00618618|144479965|SUPERIORITY_OR_OTHER||LS mean Difference|0.0||||0.852|TWO_SIDED|95.0|-0.4|0.4|||Repeated Measures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 24||0.4|-0.4|0.852
72477070|NCT00618618|144479965|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2||||0.444|TWO_SIDED|95.0|-0.6|0.3|||Repeated Measures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 24||0.3|-0.6|0.444
72477071|NCT00618618|144479965|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1||||0.724|TWO_SIDED|95.0|-0.3|0.5|||Repeated Measures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 24||0.5|-0.3|0.724
72477072|NCT00618618|144479966|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0||||0.934|TWO_SIDED|95.0|-0.4|0.4|||Repeated Measures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 4||0.4|-0.4|0.934
72477073|NCT00618618|144479966|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2||||0.286|TWO_SIDED|95.0|-0.7|0.2|||Repeated Measures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 4||0.2|-0.7|0.286
72477074|NCT00618618|144479966|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3||||0.19|TWO_SIDED|95.0|-0.1|0.7|||Repeated Measures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 4||0.7|-0.1|0.190
72508592|NCT01070550|144548046|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.529||||0.0083|TWO_SIDED|95.0|1.116|2.097|||Regression, Logistic|||The statistical analysis is presented for age per 10 years. The logistic regression analysis for relapse 24 weeks after EOT was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||2.097|1.116|0.0083
72477075|NCT00618618|144479966|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2||||0.402|TWO_SIDED|95.0|-0.5|0.2|||Repeated Measures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 8||0.2|-0.5|0.402
72477076|NCT00618618|144479966|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2||||0.29|TWO_SIDED|95.0|-0.7|0.2|||Repeated Measures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 8||0.2|-0.7|0.290
72477077|NCT00618618|144479966|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0||||0.863|TWO_SIDED|95.0|-0.4|0.4|||Repeated Measures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 8||0.4|-0.4|0.863
72477078|NCT00618618|144479966|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3||||0.128|TWO_SIDED|95.0|-0.7|0.1|||Repeated Measures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 12||0.1|-0.7|0.128
72477079|NCT00618618|144479966|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.5||||0.018|TWO_SIDED|95.0|-0.9|-0.1|||Repeated Measures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 12||-0.1|-0.9|0.018
72477080|NCT00618618|144479966|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1||||0.489|TWO_SIDED|95.0|-0.5|0.3|||Repeated Measures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 12||0.3|-0.5|0.489
72477081|NCT00618618|144479966|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.5||||0.007|TWO_SIDED|95.0|-0.9|-0.1|||Repeated Measures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 16||-0.1|-0.9|0.007
72477082|NCT00618618|144479966|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.8|||<|0.001|TWO_SIDED|95.0|-1.3|-0.4|||Repeated Measures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 16||-0.4|-1.3|<0.001
72477083|NCT00618618|144479966|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3||||0.122|TWO_SIDED|95.0|-0.7|0.1|||Repeated Measures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 16||0.1|-0.7|0.122
72566369|NCT02697773|144663267|SUPERIORITY||Odds Ratio (OR)|2.12||||0.0003|TWO_SIDED|95.0|1.4|3.19|||Regression, Logistic|||Week 2, \>=50%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.19|1.40|0.0003
72399649|NCT01466348|144306635|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|6.5|||<|0.0001|TWO_SIDED|95.0|4.5|8.4|||ANOVA|No baseline covariate adjustment was applied.|A positive difference favors the paracetamol/ caffeine treatment.|Null hypothesis was no difference in treatments in the change from baseline in the number of valid responses from the RVIP.||8.4|4.5|<0.0001
72477084|NCT00618618|144479966|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.6||||0.005|TWO_SIDED|95.0|-0.9|-0.2|||Repeated Measures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 24||-0.2|-0.9|0.005
72508593|NCT01070550|144548046|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.285||||0.0028|TWO_SIDED|95.0|1.09|1.515|||Regression, Logistic|||The statistical analysis is presented for weight per 10 kg. The logistic regression analysis for relapse 24 weeks after EOT was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.515|1.090|0.0028
72566370|NCT02697773|144663267|SUPERIORITY||Odds Ratio (OR)|2.44||||0.0005|TWO_SIDED|95.0|1.48|4.01|||Regression, Logistic|||Week 2, \>=70%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||4.01|1.48|0.0005
72566371|NCT02697773|144663267|SUPERIORITY||Odds Ratio (OR)|2.39||||0.0006|TWO_SIDED|95.0|1.45|3.94|||Regression, Logistic|||Week 2, \>=70%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.94|1.45|0.0006
72399650|NCT03989440|144306656|SUPERIORITY||LS Mean Difference|0.54||||0.59|TWO_SIDED|95.0|-1.48|2.55|||Mixed Models Analysis|||||2.55|-1.48|0.59
72477085|NCT00618618|144479966|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.8|||<|0.001|TWO_SIDED|95.0|-1.2|-0.3|||Repeated Measures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 24||-0.3|-1.2|<0.001
72477086|NCT00618618|144479966|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.6||||0.007|TWO_SIDED|95.0|-1.0|-0.2|||Repeated Measures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 24||-0.2|-1.0|0.007
72477087|NCT00618618|144479968|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.9||||0.573|TWO_SIDED|95.0|-8.6|4.8|||ANCOVA|Based on an ANCOVA model with treatment as the main effect and baseline SMF Rating Scale score as a covariate.||||4.8|-8.6|0.573
72477088|NCT00618618|144479968|SUPERIORITY_OR_OTHER||LS Mean Difference|1.8||||0.653|TWO_SIDED|95.0|-6.3|9.9|||ANCOVA|Based on an ANCOVA model with treatment as the main effect and baseline SMF Rating Scale score as a covariate.||||9.9|-6.3|0.653
72477089|NCT00618618|144479968|SUPERIORITY_OR_OTHER||LS Mean Difference|1.4||||0.688|TWO_SIDED|95.0|-5.4|8.1|||ANCOVA|Based on an ANCOVA model with treatment as the main effect and baseline SMF Rating Scale score as a covariate.||||8.1|-5.4|0.688
72477090|NCT02929329|144479970|SUPERIORITY|"The overall type I error was 0.05 for 2-sided testing across primary and secondary outcomes.~Control for multiple comparisons was achieved using the following testing algorithm: if the primary outcome met the P-value threshold of 0.05, the alpha error would be divided unequally between cardiovascular death (96% of the overall alpha error, or 0.048) and change from baseline to week 24 in the Kansas City Cardiomyopathy Questionnaire total symptom score (4% of the overall alpha error, or 0.002)."|Hazard Ratio (HR)|0.92||||0.0252|TWO_SIDED|95.0|0.86|0.99|||Regression, Cox|Stratified by randomization setting and region, including terms for baseline estimated glomerular filtration rate (eGFR) and treatment group.|Cox proportional-hazards model with baseline hazards stratified according to the randomization setting and geographic region and with the treatment group and baseline eGFR as covariates.|||0.99|0.86|0.0252
72477091|NCT02929329|144479970|SUPERIORITY|||||||0.0211|||||||Stratified log-rank test|Log-rank test stratified by randomization setting and region.||||||0.0211
72477092|NCT02929329|144479970|SUPERIORITY||Hazard Ratio (HR)|0.92|||||TWO_SIDED|95.0|0.86|0.99|||||Cox proportional-hazards model with baseline hazards stratified according to the randomization setting and geographic region and with the treatment group and baseline eGFR as covariates.|Competing risk subdistribution hazard ratio and associated 95% confidence intervals for treatment were computed. Deaths not included in the endpoint were considered as the competing risk.||0.99|0.86|
72477093|NCT02929329|144479971|SUPERIORITY||Hazard Ratio (HR)|1.01||||0.8555|TWO_SIDED|95.0|0.92|1.11||If significance for the primary outcome was determined, cardiovascular death was tested against an alpha of 0.048.|Regression, Cox|Stratified by randomization setting and region, including terms for baseline eGFR and treatment group.|Cox proportional-hazards model with baseline hazards stratified according to the randomization setting and geographic region and with the treatment group and baseline eGFR as covariates.|||1.11|0.92|0.8555
72477094|NCT02929329|144479971|SUPERIORITY||Hazard Ratio (HR)|1.01|||||TWO_SIDED|95.0|0.92|1.11|||||Cox proportional-hazards model with baseline hazards stratified according to the randomization setting and geographic region and with the treatment group and baseline eGFR as covariates.|Competing risk subdistribution hazard ratio and associated 95% confidence intervals for treatment were computed. Deaths not included in the endpoint were considered as the competing risk.||1.11|0.92|
72477095|NCT02929329|144479972|OTHER||Least Squares (LS) Mean Difference|-0.46|STANDARD_ERROR_OF_MEAN|0.48|||TWO_SIDED|95.0|-1.4|0.48|||||Treatment difference = Omecamtiv mecarbil - Placebo|||0.48|-1.40|
72477096|NCT02929329|144479972|OTHER||LS Mean Difference|2.5|STANDARD_ERROR_OF_MEAN|1.0|||TWO_SIDED|95.0|0.54|4.46|||||Treatment difference = Omecamtiv mecarbil - Placebo|||4.46|0.54|
72477097|NCT02929329|144479972|SUPERIORITY|If significance for the primary outcome was determined, change from baseline in the KCCQ total symptom score was tested against an alpha of 0.002.||||||0.0278|||||||Omnibus F-test|||||||0.0278
72477098|NCT02929329|144479972|OTHER||Pooled treatment difference|0.75|||||TWO_SIDED|95.0|-2.55|4.51|||||Overall pooled estimate of treatment difference (Omecamtiv mecarbil - Placebo) using random effects meta-analysis approach.|||4.51|-2.55|
72508594|NCT01070550|144548046|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.061||||0.0002|TWO_SIDED|95.0|1.401|3.032|||Regression, Logistic|||The statistical analysis is presented for HCV RNA at BL in log10(IU/mL). The logistic regression analysis for relapse 24 weeks after EOT was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||3.032|1.401|0.0002
72477099|NCT02929329|144479972|SUPERIORITY||LS Mean Difference|-0.71|||||TWO_SIDED|95.0|-1.62|0.2|||||Treatment difference = Omecamtiv mecarbil - Placebo|As a sensitivity for missing data due to death, joint longitudinal and survival models were fit using KCCQ TSS observed values with random subject slopes and intercepts for the longitudinal models with terms for baseline eGFR, region, and treatment by slope. The survival models were fit for all-cause death with baseline eGFR and treatment in the proportional hazard part of the models, KCCQ TSS modeled values as the shared parameterization, stratified by region with Weibull baseline functions.||0.20|-1.62|
72508595|NCT01070550|144548046|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.327||||0.0019|TWO_SIDED|95.0|0.162|0.662|||Regression, Logistic|||The statistical analysis is presented for liver fibrosis (no cirrhosis vs cirrhosis). The logistic regression analysis for relapse 24 Weeks after EOT was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.662|0.162|0.0019
72508596|NCT01070550|144548046|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.32||||0.0086|TWO_SIDED|95.0|0.137|0.749|||Regression, Logistic|||The statistical analysis is presented for liver fibrosis (not assessed/missed vs cirrhosis). The logistic regression analysis for relapse 24 weeks after EOT was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.749|0.137|0.0086
72508597|NCT01070550|144548046|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.247|||<|0.0001|TWO_SIDED|95.0|0.138|0.441|||Regression, Logistic|||The statistical analysis is presented for on-treatment response, combined (RVR vs NO RVR). The logistic regression analysis for relapse 24 weeks after EOT was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.441|0.138|<0.0001
72566372|NCT02697773|144663267|SUPERIORITY||Odds Ratio (OR)|2.1||||0.0436|TWO_SIDED|95.0|1.02|4.32|||Regression, Logistic|||Week 2, \>=90%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||4.32|1.02|0.0436
72399651|NCT03989440|144306657|SUPERIORITY||LS Mean Difference|-1.56||||0.13|TWO_SIDED|95.0|-3.62|0.5|||Mixed Models Analysis|||||0.50|-3.62|0.13
72399652|NCT03989440|144306658|SUPERIORITY||LS Mean Difference|-1.16||||0.16|TWO_SIDED|95.0|-2.81|0.5|||Mixed Models Analysis|||||0.50|-2.81|0.16
72477100|NCT02929329|144479972|SUPERIORITY||LS mean difference|2.31|||||TWO_SIDED|95.0|0.8|3.82|||||Treatment difference = Omecamtiv mecarbil - Placebo|As a sensitivity for missing data due to death, joint longitudinal and survival models were fit using KCCQ TSS observed values with random subject slopes and intercepts for the longitudinal models with terms for baseline eGFR, region, and treatment by slope. The survival models were fit for all-cause death with baseline eGFR and treatment in the proportional hazard part of the models, KCCQ TSS modeled values as the shared parameterization, stratified by region with Weibull baseline functions.||3.82|0.80|
72477101|NCT02929329|144479973|SUPERIORITY||Hazard Ratio (HR)|0.95||||0.1902|TWO_SIDED|95.0|0.87|1.03||If statistical significance was achieved for both the time to CV death and change from baseline in the KCCQ TSS, time to first heart failure hospitalization was to be tested at the full alpha.|Regression, Cox|Stratified by randomization setting and region, including terms for baseline eGFR and treatment group.|Cox proportional-hazards model with baseline hazards stratified according to the randomization setting and geographic region and with the trial group and the baseline eGFR as covariates.|||1.03|0.87|0.1902
72477102|NCT02929329|144479973|SUPERIORITY||Hazard Ratio (HR)|0.96|||||TWO_SIDED|95.0|0.88|1.04|||||Cox proportional-hazards model with baseline hazards stratified according to the randomization setting and geographic region and with the trial group and the baseline eGFR as covariates.|Competing risk subdistribution hazard ratio and associated 95% confidence intervals for treatment were computed. Deaths not included in the endpoint are considered as the competing risk.||1.04|0.88|
72477103|NCT02929329|144479974|SUPERIORITY||Hazard Ratio (HR)|1.0||||0.9633|TWO_SIDED|95.0|0.92|1.09||If time to first heart failure hospitalization was statistically significant, time to all-cause death was to be tested with the same alpha as time to first heart failure hospitalization.|Regression, Cox||Cox proportional-hazards model with baseline hazards stratified according to the randomization setting and geographic region and with the trial group and the baseline eGFR as covariates.|||1.09|0.92|0.9633
72477104|NCT01183234|144479975|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Point estimates and 90% confidence intervals for the ratio of the treatment regimen means were provided by back-transformation on to the linear scale and were assessed against the currently accepted bioequivalence criteria for log-transformed data (0.80, 1.25).|Ratio of geometric LS means|0.953|||||TWO_SIDED|90.0|0.915|0.993|||Mixed Models Analysis|||||0.993|0.915|
72477105|NCT01183234|144479976|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Point estimates and 90% confidence intervals for the ratio of the treatment regimen means were provided by back-transformation on to the linear scale and were assessed against the currently accepted bioequivalence criteria for log-transformed data (0.80, 1.25).|Ratio of geometric LS means|0.988|||||TWO_SIDED|90.0|0.931|1.05|||Mixed Models Analysis|||||1.05|0.931|
72477106|NCT01183234|144479977|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|0.0|||||TWO_SIDED|90.0|-0.15|0.492|||Wilcoxon (Hodges-Lehmann)|||||0.492|-0.150|
72477107|NCT00704379|144479978|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|3.6|||<|0.05|TWO_SIDED|95.0|1.1|16.2|||Log Rank|||||16.2|1.1|<0.05
72477108|NCT00560560|144480002|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||The final analysis was intended to be a binomial test (death prior to 6 months, yes or no). However, 2 participants in the 30/kg mg group were censored prior to 6 months, so the six month Kaplan and Meier estimates were used for each group instead.|Test of probability of 6 month survival|p-Value \>0.05 applies to each group (20 mg/kg and 30 mg/kg). Greenwood's formula was used for standard deviation.||The hypotheses for each group were H0:p=0.45 vs H1:p\>0.45. There was one interim analysis for futility for each group based on the method of Case and Morgan. The futility boundary was not crossed for 20/kg mg group, but was crossed for the 30/kg mg group. It was recommended to investigators that participants be discontinued from treatment with 30 mg/kg of figitumumab.||||>0.05
72477109|NCT00037830|144480029|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||The null hypothesis for Phase I was that at week 24, there is no difference between UPDRS motor scores in placebo vs. GM1-treated subjects.||||<0.0001
72477110|NCT00037830|144480030|SUPERIORITY_OR_OTHER|||||||0.0368|||||||t-test, 2 sided|||The null hypothesis for Phase II is that long-term use of GM1 does not affect the progression of PD symptoms and that there is no benefit to early start of GM1 use.||||0.0368
72477111|NCT00037830|144480031|SUPERIORITY_OR_OTHER|||||||0.1903|||||||estimate of slope of change over time|random intercept model and a variance components covariance structure||||||0.1903
72508598|NCT01809262|144548068|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.07|STANDARD_ERROR_OF_MEAN|0.02||0.0005||95.0|0.031|0.109|||ANCOVA|||||0.109|0.031|0.0005
72477112|NCT00037830|144480031|SUPERIORITY_OR_OTHER|||||||0.0063||95.0|||||estimate slope of change over time|random intercept model and a variance components covariance structure||||||0.0063
72477113|NCT00037830|144480032|SUPERIORITY_OR_OTHER|||||||0.0502|||||||estimate of slope of change over time|random intercept model and a variance components covariance structure||||||0.0502
72477114|NCT00037830|144480032|SUPERIORITY_OR_OTHER|||||||0.0003||95.0|||||estimate slope of change over time|random intercept model and a variance components covariance structure||||||0.0003
72477115|NCT00037830|144480033|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
72477116|NCT00037830|144480034|SUPERIORITY_OR_OTHER|||||||0.131|||||||t-test, 2 sided|||||||0.1310
72477117|NCT00037830|144480035|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||t-test, 2 sided|||Analysis was paired sample t-test on change from baseline.||||<0.05
72477118|NCT00037830|144480036|SUPERIORITY_OR_OTHER||||||<|0.01||95.0|||||t-test, 2 sided|||||||<0.01
72508599|NCT01809262|144548068|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.099|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001||95.0|0.06|0.138|||ANCOVA|||||0.138|0.060|<0.0001
72477119|NCT00037830|144480037|SUPERIORITY_OR_OTHER||||||<|0.01||95.0|||||t-test, 2 sided|||||||<0.01
72477120|NCT00037830|144480038|SUPERIORITY_OR_OTHER||||||<|0.01||95.0|||||t-test, 2 sided|||||||<0.01
72477121|NCT03292432|144480045|SUPERIORITY||Risk Difference (RD)|-3.5||||0.8|TWO_SIDED|95.0|-21.8|15.2|||Fisher Exact||Risk difference reflects percentage of participants achieving HIV-1 RNA \< 50 copies/mL in TERA arm minus SOC arm|||15.2|-21.8|0.80
72477122|NCT03292432|144480046|SUPERIORITY||Risk Difference (RD)|-0.7|||>|0.99|TWO_SIDED|95.0|-20.9|19.6|||Fisher Exact||Risk difference reflects percentage of participants achieving HIV-1 RNA \< 200 copies/ml in TERA arm minus SOC arm|||19.6|-20.9|>0.99
72477123|NCT03292432|144480047|SUPERIORITY||Risk Difference (RD)|-13.1||||0.24|TWO_SIDED|95.0|-32.1|7.2|||Fisher Exact||Risk difference reflects percentage of participants with HIV-1 RNA \< 50 copies/mL at Week 24 in TERA arm minus SOC arm|Comparison of percentages at Week 24||7.2|-32.1|0.24
72508600|NCT01809262|144548068|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.113|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001||95.0|0.074|0.152|||ANCOVA|||||0.152|0.074|<0.0001
72508601|NCT01809262|144548068|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.119|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001||95.0|0.08|0.158|||ANCOVA|||||0.158|0.080|<0.0001
72399653|NCT03989440|144306659|SUPERIORITY||% Difference in responder rate|-9.3||||0.68|TWO_SIDED|95.0|-43.3|25.4|||Fisher Exact|||||25.4|-43.3|0.68
72477124|NCT03292432|144480047|SUPERIORITY||Risk Difference (RD)|3.8||||0.76|TWO_SIDED|95.0|-16.0|22.6|||Fisher Exact||Risk difference reflects percentage of participants with HIV-1 RNA \< 50 copies/mL at Week 36 in TERA arm minus SOC arm|Comparison of percentages at Week 36||22.6|-16.0|0.76
72477125|NCT03292432|144480047|SUPERIORITY||Risk Difference (RD)|3.6|||>|0.99|TWO_SIDED|95.0|-21.8|27.4|||Fisher Exact||Risk difference reflects percentage of participants with HIV-1 RNA \< 50 copies/mL at Week 48 in TERA arm minus SOC arm|Comparison of percentages at Week 48||27.4|-21.8|>0.99
72477126|NCT03292432|144480048|SUPERIORITY||Risk Difference (RD)|-13.0||||0.26|TWO_SIDED|95.0|-32.7|7.3|||Fisher Exact||Risk difference reflects percentage of participants with HIV-1 RNA \< 200 copies/mL at Week 24 in TERA arm minus SOC arm|Comparison of percentages at Week 24||7.3|-32.7|0.26
72477127|NCT03292432|144480048|SUPERIORITY||Risk Difference (RD)|11.5||||0.42|TWO_SIDED|95.0|-11.2|32.8|||Fisher Exact||Risk difference reflects percentage of participants with HIV-1 RNA \< 200 copies/mL at Week 36 in TERA arm minus SOC arm|Comparison of percentages at Week 36||32.8|-11.2|0.42
72477128|NCT03292432|144480048|SUPERIORITY||Risk Difference (RD)|-4.4||||0.77|TWO_SIDED|95.0|-29.5|20.7|||Fisher Exact||Risk difference reflects percentage of participants with HIV-1 RNA \< 200 copies/mL at Week 48 in TERA arm minus SOC arm|Comparison of percentages at Week 48||20.7|-29.5|0.77
72477129|NCT03292432|144480049|SUPERIORITY||Risk Difference (RD)|5.8||||0.67|TWO_SIDED|95.0|-14.6|25.3|||Fisher Exact||Risk difference reflects percentage of participants with HIV-1 RNA \< 200 copies/mL at Week 12 and maintained to Week 48 in TERA arm minus SOC arm|||25.3|-14.6|0.67
72477130|NCT03292432|144480050|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Comparison of percentages of doses taken from Weeks 0 -12||||<0.001
72477131|NCT03292432|144480050|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Comparison of percentage of doses taken from Weeks \>12 to 24||||<0.001
72477132|NCT03292432|144480050|SUPERIORITY|||||||0.06|||||||Wilcoxon (Mann-Whitney)|||Comparison of percentage of doses taken from Weeks \>24 to 36||||0.06
72477133|NCT03292432|144480050|SUPERIORITY|||||||0.5|||||||Wilcoxon (Mann-Whitney)|||Comparison of percentage of doses taken from Weeks \>36 to 48||||0.50
72477134|NCT03292432|144480051|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Comparison of percentage of doses taken on time from Weeks 0 - 12||||<0.001
72477135|NCT03292432|144480051|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Comparison of percentage of doses taken on time from Weeks \>12 - 24||||<0.001
72477136|NCT03292432|144480051|SUPERIORITY|||||||0.05||||||p-value equal to a priori threshold for statistical significance|Wilcoxon (Mann-Whitney)|||Comparison of percentages of doses taken on time from Weeks \>24 - 36||||0.05
72477137|NCT03292432|144480051|SUPERIORITY|||||||0.49|||||||Wilcoxon (Mann-Whitney)|||Comparison of doses taken on time from Weeks \>36 - 48||||0.49
72477138|NCT03292432|144480052|SUPERIORITY||Risk Ratio (RR)|2.51|||<|0.001|TWO_SIDED|95.0|1.9|3.33|||Chi-squared|Pearson Chi-square test from generalized linear model with Poisson link|Risk ratio for SOC arm relative to TERA arm|Comparison of incidence rates from Weeks 0 - 12||3.33|1.90|<0.001
72477139|NCT03292432|144480052|SUPERIORITY||Risk Ratio (RR)|1.56|||<|0.001|TWO_SIDED|95.0|1.29|1.89|||Chi-squared|Pearson Chi-square test from generalized linear model with Poisson link|Risk ratio for SOC arm relative to TERA arm|Comparison of incidence rates from Weeks \>12 - 24||1.89|1.29|<0.001
72477140|NCT03292432|144480052|SUPERIORITY||Risk Ratio (RR)|1.23||||0.02|TWO_SIDED|95.0|1.03|1.47|||Chi-squared|Pearson Chi-square test from generalized linear model with Poisson link|P-value from Pearson Chi-square test from generalized linear model with Poisson link|Comparison of incidence rates from Weeks \>24 - 36||1.47|1.03|0.020
72477141|NCT03292432|144480052|SUPERIORITY||Risk Ratio (RR)|1.08||||0.39|TWO_SIDED|95.0|0.9|1.3|||Chi-squared|Pearson Chi-square test from generalized linear model with Poisson link|Risk ratio for SOC arm relative to TERA arm|Comparison of incidence rates from Weeks \>36 - 48||1.30|0.90|0.39
72477142|NCT03292432|144480053|SUPERIORITY||Risk Difference (RD)|2.3|||>|0.99|TWO_SIDED|95.0|-16.4|21.1|||Fisher Exact||Risk difference reflects percentage of participants achieving HIV-1 RNA \< 200 copies/mL in TERA arm minus SOC arm|||21.1|-16.4|>0.99
72477143|NCT03292432|144480054|SUPERIORITY||Risk Difference (RD)|4.7||||0.71|TWO_SIDED|95.0|-9.0|19.4|||Fisher Exact||Risk difference reflects percentage of participants achieving sustained virologic control in TERA arm minus SOC arm|||19.4|-9.0|0.71
72477144|NCT01014143|144480063|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANOVA|||The null hypothesis states that there is no difference between groups.||||0.05
72477145|NCT03699085|144480077|EQUIVALENCE|A p value of \< 0.05 suggests the groups are different.||||||0.38||||||A p value of \< 0.05 suggests the groups are different.|Wilcoxon (Mann-Whitney)|||Wilcoxon rank-sum test is used, which ranks the values in each group, sums the ranks and determines the probability that they are the same. The probability p-value is reported.||||0.38
72508602|NCT01809262|144548069|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.108|STANDARD_ERROR_OF_MEAN|0.016|<|0.0001||95.0|0.077|0.139|||ANCOVA|||||0.139|0.077|<0.0001
72477146|NCT03699085|144480078|SUPERIORITY|Adjusted mixed effects regression models were used to determine whether patients in the intervention and control group manifested different patterns of change in days of heroin use in the past 30 days in terms of incidence-rate ratio. We applied a negative binomial distribution to help account for overdispersion of outcome data.|Incidence rate ratio|1.29||||0.68|TWO_SIDED|95.0|0.38|4.37||A p value of \< 0.05 suggests the groups are different.|Regression, Cox||A number greater than 1.0 indicates a higher incidence rate of heroin use in past 30 days for intervention group compared to control group|Comparison of control and intervention populations based on substance use measured utilizing a time-line follow back (TLFB) calendar administered by the research assistant to for past 30-day heroin use. This is a covariate-adjusted mixed effects regression model at TLFB timepoint of 6 months. A number greater than 1.0 indicates a higher incidence of heroin use in the past 30 days at the 6 month timepoint for intervention group compared to control group.||4.37|0.38|0.68
72477147|NCT01859988|144480094|SUPERIORITY_OR_OTHER||Least square (LS) mean difference|-55.7|STANDARD_ERROR_OF_MEAN|6.74|<|0.0001|TWO_SIDED|95.0|-68.9|-42.4||Threshold for significance at 0.05 level.|ANCOVA||Dupilumab 300 mg qw vs Placebo|LS mean and standard error were obtained using analysis of covariance (ANCOVA) model with treatment and randomization strata (moderate vs severe;Japan vs rest of world) and relevant baseline values as covariates. Multiplicity was controlled using hierarchical testing procedure:highest dose vs. placebo was tested first. Comparison order was 300 mg qw,300 mg q2w,200 mg q2w,300 mg q4w \& 100 mg q4w, vs placebo respectively. Testing continues only if previous comparison was statistically significant.||-42.4|-68.9|<0.0001
72477148|NCT01859988|144480094|SUPERIORITY_OR_OTHER||LS mean difference|-50.1|STANDARD_ERROR_OF_MEAN|6.67|<|0.0001|TWO_SIDED|95.0|-63.3|-37.0||Threshold for significance at 0.05 level.|ANCOVA||Dupilumab 300 mg q2w vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-37.0|-63.3|<0.0001
72477149|NCT01859988|144480094|SUPERIORITY_OR_OTHER||LS mean difference|-47.4|STANDARD_ERROR_OF_MEAN|6.76|<|0.0001|TWO_SIDED|95.0|-60.6|-34.1||Threshold for significance at 0.05 level.|ANCOVA||Dupilumab 200 mg q2w vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-34.1|-60.6|<0.0001
72477150|NCT01859988|144480094|SUPERIORITY_OR_OTHER||LS mean difference|-45.4|STANDARD_ERROR_OF_MEAN|6.66|<|0.0001|TWO_SIDED|95.0|-58.5|-32.3||Threshold for significance at 0.05 level.|ANCOVA||Dupilumab 300 mg q4w vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-32.3|-58.5|<0.0001
72477151|NCT01859988|144480094|SUPERIORITY_OR_OTHER||LS mean difference|-26.8|STANDARD_ERROR_OF_MEAN|6.65|<|0.0001|TWO_SIDED|95.0|-39.8|-13.7||Threshold for significance at 0.05 level.|ANCOVA||Dupilumab 100 mg q4w vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-13.7|-39.8|<0.0001
72566373|NCT02697773|144663267|SUPERIORITY||Odds Ratio (OR)|1.76||||0.1348|TWO_SIDED|95.0|0.84|3.69|||Regression, Logistic|||Week 2, \>=90%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.69|0.84|0.1348
72566374|NCT02697773|144663267|SUPERIORITY||Odds Ratio (OR)|2.3|||<|0.0001|TWO_SIDED|95.0|1.58|3.36|||Regression, Logistic|||Week 4, \>=30%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.36|1.58|<.0001
72566375|NCT02697773|144663267|SUPERIORITY||Odds Ratio (OR)|2.12|||<|0.0001|TWO_SIDED|95.0|1.46|3.09|||Regression, Logistic|||Week 4, \>=30%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.09|1.46|<.0001
72399654|NCT04259762|144306701|OTHER|This is a summary of the total number of participants in the focus groups who endorsed the particular theme.|Proportion endorsing themes|1.0|||||TWO_SIDED|||||||||All focus groups were summarized together and, therefore, the denominators (N=85 \[Community\], N=11 \[Provider\]) for each theme are the same. Further, the focus groups only made qualitative (and no quantitative) assessments/endoresement of themes. No formal comparisons among groups were made.||||
72477152|NCT02065687|144480115|EQUIVALENCE|The null hypothesis is that there is no relationship between BMI and metformin treatment (i.e. the parameter associated with the interaction term of BMI \* treatment is equal to 0).|Cox Proportional Hazard|-0.01787|STANDARD_ERROR_OF_MEAN|0.27472||0.9482|TWO_SIDED||||||Regression, Cox|||The interaction between BMI and metformin treatment will be examined with an interaction term in a Cox proportional hazards model. Historical data indicate that approximately 50% of people are obese (BMI\>=30). For the purposes of examining the relationship, we will classify patients into two levels (high versus low) at the median BMI, which will increase the likelihood of detecting an interaction between metformin treatment and obesity.||||0.9482
72477153|NCT01871805|144480122|SUPERIORITY|||||||0.0056||||||Tests null hypothesis that the response rate is equal to 35% versus the alternative hypothesis that the response rate is not equal to 35%.|Exact Clopper-Pearson CI, 2 sided|||||||0.0056
72477154|NCT01871805|144480123|SUPERIORITY|||||||0.0251||||||Tests null hypothesis that the response rate is equal to 35% versus the alternative hypothesis that the response rate is not equal to 35%.|Exact Clopper-Pearson CI, 2 sided|||||||0.0251
72477155|NCT01871805|144480123|SUPERIORITY|||||||0.0203||||||Tests null hypothesis that the response rate is equal to 35% versus the alternative hypothesis that the response rate is not equal to 35%.|Exact Clopper-Pearson CI, 2 sided|||||||0.0203
72477156|NCT01871805|144480125|SUPERIORITY|||||||0.001||||||Tests null hypothesis that the response rate is equal to 35% versus the alternative hypothesis that the response rate is not equal to 35%.|Exact Clopper-Pearson CI, 2 sided|||||||0.0010
72477157|NCT01131182|144480181|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0005||95.0||||Assessed for relative risk using prior therapy (monotherapy or combination therapy) as a stratification factor.|Cochran-Mantel-Haenszel|||||||0.0005
72566376|NCT02697773|144663267|SUPERIORITY||Odds Ratio (OR)|2.41|||<|0.0001|TWO_SIDED|95.0|1.62|3.57|||Regression, Logistic|||Week 4, \>=50%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.57|1.62|<.0001
72477158|NCT00662818|144480183|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.62||||0.329|TWO_SIDED|95.0|0.62|4.25|||Regression, Logistic|Computed using a logistic regression model adjusting for geographic region, baseline migraine severity, and age.||||4.25|0.62|0.329
72477159|NCT00662818|144480184|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.44||||0.42|TWO_SIDED|95.0|0.59|3.5|||Regression, Logistic|Computed using a logistic regression model adjusting for geographic region, baseline migraine severity, and age.||||3.50|0.59|0.420
72477160|NCT00662818|144480188|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.22||||0.648|TWO_SIDED|95.0|0.52|2.85|||Regression, Logistic|Computed using a logistic regression model adjusting for geographic region, baseline migraine severity, and age.||||2.85|0.52|0.648
72477161|NCT00662818|144480189|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.8||||0.647|TWO_SIDED|95.0|0.31|2.07|||Regression, Logistic|Computed using a logistic regression model adjusting for geographic region, baseline migraine severity, and age.||||2.07|0.31|0.647
72399655|NCT04259762|144306703|OTHER|Formal statistical comparisons were not made.|Proportion endorsing attempt to screen|0.567|||||TWO_SIDED|95.0|0.303|0.831|||||"Pooled estimate of attempt to screening. Using R:~n1 \<- c(20,28,11,15,26,23,21); nt \<- c(45,50,45,50,50,50,22) p1 \<- n1/nt; v1 \<- p1\*(1-p1)/nt fit \<- lm(p1 \~ 1,weight=1/v1) summary(fit)$coef\[1\] + qt(.975,6)\*c(0,-1,1)\*summary(fit)$coef\[2\]"|||0.831|0.303|
72477162|NCT00662818|144480190|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.83||||0.201|TWO_SIDED|95.0|0.73|4.6|||Regression, Logistic|Computed using a logistic regression model adjusting for geographic region, baseline migraine severity, and age.||||4.60|0.73|0.201
72477163|NCT00662818|144480191|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.35||||0.579|TWO_SIDED|95.0|0.47|3.85|||Regression, Logistic|Computed using a logistic regression model adjusting for geographic region, baseline migraine severity, and age.||||3.85|0.47|0.579
72477164|NCT04602221|144480192|OTHER||Difference of adjusted means|-0.339|STANDARD_ERROR_OF_MEAN|3.8242||0.9296|TWO_SIDED|95.0|-7.975|7.297|||ANCOVA||The difference was calculated as treatment group minus placebo group.|A linear mixed effects model, i.e. analyses of covariance (ANCOVA) was used for analysis of the primary endpoint. This model included effects for sequence, subject within sequence, period, baseline values (pre-ketamine baseline and on-ketamine baseline) and treatment. The effect 'subject within sequence' were considered as random, whereas the other effects were considered as fixed.||7.297|-7.975|0.9296
72477165|NCT04602221|144480192|OTHER||Difference of adjusted means|4.002|STANDARD_ERROR_OF_MEAN|3.8224||0.299|TWO_SIDED|95.0|-3.631|11.634|||ANCOVA||The difference was calculated as treatment group minus placebo group.|A linear mixed effects model, i.e. analyses of covariance (ANCOVA) was used for analysis of the primary endpoint. This model included effects for sequence, subject within sequence, period, baseline values (pre-ketamine baseline and on-ketamine baseline) and treatment. The effect 'subject within sequence' were considered as random, whereas the other effects were considered as fixed.||11.634|-3.631|0.2990
72477166|NCT04602221|144480192|OTHER||Difference of adjusted means|-1.258|STANDARD_ERROR_OF_MEAN|3.6608||0.7322|TWO_SIDED|95.0|-8.565|6.05|||ANCOVA||The difference was calculated as treatment group minus placebo group.|A linear mixed effects model, i.e. analyses of covariance (ANCOVA) was used for analysis of the primary endpoint. This model included effects for sequence, subject within sequence, period, baseline values (pre-ketamine baseline and on-ketamine baseline) and treatment. The effect 'subject within sequence' were considered as random, whereas the other effects were considered as fixed.||6.050|-8.565|0.7322
72477167|NCT04602221|144480193|OTHER||Difference of adjusted means|0.347|STANDARD_ERROR_OF_MEAN|1.563||0.8249|TWO_SIDED|95.0|-2.776|3.471|||ANCOVA||The difference was calculated as treatment group minus placebo group.|A linear mixed effects model, i.e. analyses of covariance (ANCOVA) was used for analysis of the secondary endpoint. This model included effects for sequence, subject within sequence, period, baseline values (pre-ketamine baseline and on-ketamine baseline) and treatment. The effect 'subject within sequence' were considered as random, whereas the other effects were considered as fixed.||3.471|-2.776|0.8249
72477168|NCT04602221|144480193|OTHER||Difference of adjusted means|-1.085|STANDARD_ERROR_OF_MEAN|1.5889||0.4973|TWO_SIDED|95.0|-4.26|2.091|||ANCOVA||The difference was calculated as treatment group minus placebo group.|A linear mixed effects model, i.e. analyses of covariance (ANCOVA) was used for analysis of the secondary endpoint. This model included effects for sequence, subject within sequence, period, baseline values (pre-ketamine baseline and on-ketamine baseline) and treatment. The effect 'subject within sequence' were considered as random, whereas the other effects were considered as fixed.||2.091|-4.260|0.4973
72477169|NCT04602221|144480193|OTHER||Difference of adjusted means|-2.858|STANDARD_ERROR_OF_MEAN|1.5266||0.0658|TWO_SIDED|95.0|-5.909|0.192|||ANCOVA||The difference was calculated as treatment group minus placebo group.|A linear mixed effects model, i.e. analyses of covariance (ANCOVA) was used for analysis of the secondary endpoint. This model included effects for sequence, subject within sequence, period, baseline values (pre-ketamine baseline and on-ketamine baseline) and treatment. The effect 'subject within sequence' were considered as random, whereas the other effects were considered as fixed.||0.192|-5.909|0.0658
72508603|NCT01809262|144548069|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.155|STANDARD_ERROR_OF_MEAN|0.016|<|0.0001||95.0|0.124|0.186|||ANCOVA|||||0.186|0.124|<0.0001
72508604|NCT01809262|144548069|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.161|STANDARD_ERROR_OF_MEAN|0.016|<|0.0001||95.0|0.13|0.192|||ANCOVA|||||0.192|0.130|<0.0001
72508605|NCT01809262|144548069|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.192|STANDARD_ERROR_OF_MEAN|0.016|<|0.0001||95.0|0.161|0.223|||ANCOVA|||||0.223|0.161|<0.0001
72508606|NCT01809262|144548070|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.099|STANDARD_ERROR_OF_MEAN|0.016|<|0.0001||95.0|0.068|0.131|||ANCOVA|||||0.131|0.068|<0.0001
72508607|NCT01809262|144548070|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.139|STANDARD_ERROR_OF_MEAN|0.016|<|0.0001||95.0|0.107|0.171|||ANCOVA|||||0.171|0.107|<0.0001
72508608|NCT01809262|144548070|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.153|STANDARD_ERROR_OF_MEAN|0.016|<|0.0001||95.0|0.122|0.185|||ANCOVA|||||0.185|0.122|<0.0001
72508609|NCT01809262|144548070|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.184|STANDARD_ERROR_OF_MEAN|0.016|<|0.0001||95.0|0.152|0.215|||ANCOVA|||||0.215|0.152|<0.0001
72508610|NCT01809262|144548071|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.087|STANDARD_ERROR_OF_MEAN|0.015|<|0.0001||95.0|0.056|0.117|||ANCOVA|||||0.117|0.056|<0.0001
72508611|NCT01809262|144548071|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.118|STANDARD_ERROR_OF_MEAN|0.015|<|0.0001||95.0|0.087|0.148|||ANCOVA|||||0.148|0.087|<0.0001
72508612|NCT01809262|144548071|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.138|STANDARD_ERROR_OF_MEAN|0.015|<|0.0001||95.0|0.107|0.168|||ANCOVA|||||0.168|0.107|<0.0001
72508613|NCT01809262|144548071|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.162|STANDARD_ERROR_OF_MEAN|0.015|<|0.0001||95.0|0.132|0.193|||ANCOVA|||||0.193|0.132|<0.0001
72508614|NCT01809262|144548072|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.074|STANDARD_ERROR_OF_MEAN|0.017|<|0.0001||95.0|0.041|0.108|||ANCOVA|||||0.108|0.041|<0.0001
72508615|NCT01809262|144548072|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.096|STANDARD_ERROR_OF_MEAN|0.017|<|0.0001||95.0|0.062|0.13|||ANCOVA|||||0.130|0.062|<0.0001
72508616|NCT01809262|144548072|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.122|STANDARD_ERROR_OF_MEAN|0.017|<|0.0001||95.0|0.089|0.156|||ANCOVA|||||0.156|0.089|<0.0001
72508617|NCT01809262|144548072|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.141|STANDARD_ERROR_OF_MEAN|0.017|<|0.0001||95.0|0.107|0.174|||ANCOVA|||||0.174|0.107|<0.0001
72508618|NCT01809262|144548073|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.121|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.084|0.158|||ANCOVA|||||0.158|0.084|<0.0001
72508619|NCT01809262|144548073|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.166|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.129|0.203|||ANCOVA|||||0.203|0.129|<0.0001
72566377|NCT02697773|144663267|SUPERIORITY||Odds Ratio (OR)|2.57|||<|0.0001|TWO_SIDED|95.0|1.74|3.82|||Regression, Logistic|||Week 4, \>=50%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.82|1.74|<.0001
72566378|NCT02697773|144663267|SUPERIORITY||Odds Ratio (OR)|2.33||||0.0003|TWO_SIDED|95.0|1.47|3.7|||Regression, Logistic|||Week 4, \>=70%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.70|1.47|0.0003
72566379|NCT02697773|144663267|SUPERIORITY||Odds Ratio (OR)|2.45||||0.0001|TWO_SIDED|95.0|1.55|3.89|||Regression, Logistic|||Week 4, \>=70%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.89|1.55|0.0001
72566380|NCT02697773|144663267|SUPERIORITY||Odds Ratio (OR)|2.02||||0.031|TWO_SIDED|95.0|1.07|3.82|||Regression, Logistic|||Week 4, \>=90%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.82|1.07|0.0310
72566381|NCT02697773|144663267|SUPERIORITY||Odds Ratio (OR)|2.31||||0.0088|TWO_SIDED|95.0|1.24|4.34|||Regression, Logistic|||Week 4, \>=90%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||4.34|1.24|0.0088
72566382|NCT02697773|144663267|SUPERIORITY||Odds Ratio (OR)|1.49||||0.036|TWO_SIDED|95.0|1.03|2.16|||Regression, Logistic|||Week 8, \>=30%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.16|1.03|0.0360
72566383|NCT02697773|144663267|SUPERIORITY||Odds Ratio (OR)|1.73||||0.0039|TWO_SIDED|95.0|1.19|2.51|||Regression, Logistic|||Week 8, \>=30%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.51|1.19|0.0039
72566384|NCT02697773|144663267|SUPERIORITY||Odds Ratio (OR)|2.12||||0.0002|TWO_SIDED|95.0|1.43|3.13|||Regression, Logistic|||Week 8, \>=50%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.13|1.43|0.0002
72566385|NCT02697773|144663267|SUPERIORITY||Odds Ratio (OR)|1.77||||0.004|TWO_SIDED|95.0|1.2|2.62|||Regression, Logistic|||Week 8, \>=50%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.62|1.20|0.0040
72566386|NCT02697773|144663267|SUPERIORITY||Odds Ratio (OR)|1.74||||0.0175|TWO_SIDED|95.0|1.1|2.74|||Regression, Logistic|||Week 8, \>=70%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.74|1.10|0.0175
72566387|NCT02697773|144663267|SUPERIORITY||Odds Ratio (OR)|1.87||||0.0065|TWO_SIDED|95.0|1.19|2.94|||Regression, Logistic|||Week 8, \>=70%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.94|1.19|0.0065
72566388|NCT02697773|144663267|SUPERIORITY||Odds Ratio (OR)|1.74||||0.0796|TWO_SIDED|95.0|0.94|3.23|||Regression, Logistic|||Week 8, \>=90%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.23|0.94|0.0796
72566389|NCT02697773|144663267|SUPERIORITY||Odds Ratio (OR)|1.76||||0.0718|TWO_SIDED|95.0|0.95|3.27|||Regression, Logistic|||Week 8, \>=90%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.27|0.95|0.0718
72508620|NCT01809262|144548073|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.176|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.139|0.214|||ANCOVA|||||0.214|0.139|<0.0001
72508621|NCT01809262|144548073|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.213|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.176|0.25|||ANCOVA|||||0.250|0.176|<0.0001
72508622|NCT01809262|144548074|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.306|STANDARD_ERROR_OF_MEAN|0.049|<|0.0001||95.0|0.21|0.402|||ANCOVA|||||0.402|0.210|<0.0001
72508623|NCT01809262|144548074|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.355|STANDARD_ERROR_OF_MEAN|0.049|<|0.0001||95.0|0.258|0.452|||ANCOVA|||||0.452|0.258|<0.0001
72508624|NCT01809262|144548074|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.35|STANDARD_ERROR_OF_MEAN|0.049|<|0.0001||95.0|0.253|0.447|||ANCOVA|||||0.447|0.253|<0.0001
72508625|NCT01809262|144548074|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.455|STANDARD_ERROR_OF_MEAN|0.049|<|0.0001||95.0|0.359|0.551|||ANCOVA|||||0.551|0.359|<0.0001
72477170|NCT04602221|144480194|OTHER||Difference of adjusted means|0.0053|STANDARD_ERROR_OF_MEAN|0.00798||0.5081|TWO_SIDED|95.0|-0.0106|0.0213|||ANCOVA||The difference was calculated as treatment group minus placebo group.|A linear mixed effects model, i.e. analyses of covariance (ANCOVA) was used for analysis of the secondary endpoint. This model included effects for sequence, subject within sequence, period, baseline values (pre-ketamine baseline and on-ketamine baseline) and treatment. The effect 'subject within sequence' were considered as random, whereas the other effects were considered as fixed.||0.0213|-0.0106|0.5081
72477171|NCT04602221|144480194|OTHER||Difference of adjusted means|0.0058|STANDARD_ERROR_OF_MEAN|0.00798||0.4723|TWO_SIDED|95.0|-0.0102|0.0217|||ANCOVA||The difference was calculated as treatment group minus placebo group.|A linear mixed effects model, i.e. analyses of covariance (ANCOVA) was used for analysis of the secondary endpoint. This model included effects for sequence, subject within sequence, period, baseline values (pre-ketamine baseline and on-ketamine baseline) and treatment. The effect 'subject within sequence' were considered as random, whereas the other effects were considered as fixed.||0.0217|-0.0102|0.4723
72477172|NCT04602221|144480194|OTHER||Difference of adjusted means|0.0333|STANDARD_ERROR_OF_MEAN|0.00767|<|0.0001|TWO_SIDED|95.0|0.018|0.0486|||ANCOVA||The difference was calculated as treatment group minus placebo group.|A linear mixed effects model, i.e. analyses of covariance (ANCOVA) was used for analysis of the secondary endpoint. This model included effects for sequence, subject within sequence, period, baseline values (pre-ketamine baseline and on-ketamine baseline) and treatment. The effect 'subject within sequence' were considered as random, whereas the other effects were considered as fixed.||0.0486|0.0180|< .0001
72477173|NCT02270515|144480201|SUPERIORITY_OR_OTHER|||||||0.002||||||This is the PCS KDQOL Subscale p-value for change in 0-6 months shown in Primary Outcome table 3.|Mixed Models Analysis|||"PCS:~From random-intercept linear mixed models with an AR(1) covariance pattern in the residual, adjusted for baseline age, sex, race (AA, all other), interview language, dialysis vintage (months), site, education (not HS grad, HS grad), marital status (married or living with partner, other), self-reported diabetes at baseline, PCP at baseline, urea reduction ratio (URR), hemoglobin (g/dL), and albumin (g/dL). The 3 lab values are time-varying covariates."||||0.002
72477174|NCT02270515|144480201|SUPERIORITY_OR_OTHER|||||||0.23||||||This is the MCS KDQOL Subscale p-value for change in 0-6 months shown in Primary Outcome table 3.|Mixed Models Analysis|||"MCS:~From random-intercept linear mixed models with an AR(1) covariance pattern in the residual, adjusted for baseline age, sex, race (AA, all other), interview language, dialysis vintage (months), site, education (not HS grad, HS grad), marital status (married or living with partner, other), self-reported diabetes at baseline, PCP at baseline, urea reduction ratio (URR), hemoglobin (g/dL), and albumin (g/dL). The 3 lab values are time-varying covariates."||||0.23
72477175|NCT02270515|144480201|SUPERIORITY_OR_OTHER|||||||0.18||||||This is the Burden KDQOL Subscale p-value for change in 0-6 months shown in Primary Outcome table 3.|Mixed Models Analysis|||"Burden:~From random-intercept linear mixed models with an AR(1) covariance pattern in the residual, adjusted for baseline age, sex, race (AA, all other), interview language, dialysis vintage (months), site, education (not HS grad, HS grad), marital status (married or living with partner, other), self-reported diabetes at baseline, PCP at baseline, urea reduction ratio (URR), hemoglobin (g/dL), and albumin (g/dL). The 3 lab values are time-varying covariates."||||0.18
72477176|NCT02270515|144480201|SUPERIORITY_OR_OTHER|||||||0.02||||||This is the Symptoms KDQOL Subscale p-value for change in 0-6 months shown in Primary Outcome table 3.|Mixed Models Analysis|||"Symptoms:~From random-intercept linear mixed models with an AR(1) covariance pattern in the residual, adjusted for baseline age, sex, race (AA, all other), interview language, dialysis vintage (months), site, education (not HS grad, HS grad), marital status (married or living with partner, other), self-reported diabetes at baseline, PCP at baseline, urea reduction ratio (URR), hemoglobin (g/dL), and albumin (g/dL). The 3 lab values are time-varying covariates."||||0.02
72477177|NCT02270515|144480201|SUPERIORITY_OR_OTHER|||||||0.004||||||This is the Effects KDQOL Subscale p-value for change in 0-6 months shown in Primary Outcome table 3.|Mixed Models Analysis|||"Effects:~From random-intercept linear mixed models with an AR(1) covariance pattern in the residual, adjusted for baseline age, sex, race (AA, all other), interview language, dialysis vintage (months), site, education (not HS grad, HS grad), marital status (married or living with partner, other), self-reported diabetes at baseline, PCP at baseline, urea reduction ratio (URR), hemoglobin (g/dL), and albumin (g/dL). The 3 lab values are time-varying covariates."||||0.004
72477178|NCT02270515|144480201|SUPERIORITY_OR_OTHER|||||||0.01||||||This is the PCS KDQOL Subscale p-value for change in 6-12 months shown in Primary Outcome table 3.|Mixed Models Analysis|||"PCS:~From random-intercept linear mixed models with an AR(1) covariance pattern in the residual, adjusted for baseline age, sex, race (AA, all other), interview language, dialysis vintage (months), site, education (not HS grad, HS grad), marital status (married or living with partner, other), self-reported diabetes at baseline, PCP at baseline, urea reduction ratio (URR), hemoglobin (g/dL), and albumin (g/dL). The 3 lab values are time-varying covariates."||||0.01
72477179|NCT02270515|144480201|SUPERIORITY_OR_OTHER|||||||0.21||||||This is the MCS KDQOL Subscale p-value for change in 6-12 months shown in Primary Outcome table 3.|Mixed Models Analysis|||"MCS:~From random-intercept linear mixed models with an AR(1) covariance pattern in the residual, adjusted for baseline age, sex, race (AA, all other), interview language, dialysis vintage (months), site, education (not HS grad, HS grad), marital status (married or living with partner, other), self-reported diabetes at baseline, PCP at baseline, urea reduction ratio (URR), hemoglobin (g/dL), and albumin (g/dL). The 3 lab values are time-varying covariates."||||0.21
72508626|NCT02064439|144548082|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.34||||0.0001|TWO_SIDED|95.0|0.2|0.59||P-value and hazard ratio estimates based on stratified proportional hazards model, with stratification based index event (DVT or PE with or without DVT).|Wald test|||Statistical analysis was performed on the first occurrence of the composite outcome.||0.59|0.20|0.0001
72508627|NCT02064439|144548082|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.26|||<|0.0001|TWO_SIDED|98.0|0.14|0.47||P-value and hazard ratio estimates based on stratified proportional hazards model, with stratification based index event (DVT or PE with or without DVT).|Wald test|||Statistical analysis was performed on the first occurrence of the composite outcome.||0.47|0.14|<0.0001
72399656|NCT01203046|144306704|NON_INFERIORITY_OR_EQUIVALENCE|It was used for the calculation of statistical power an author of 5% level, it was felt that the difference between the minimum value of non inferiority does not exceed 10%.|Odds Ratio (OR)|2.65|||<|0.05|TWO_SIDED|95.0|0.35|19.83|||Regression, Logistic|||||19.83|0.35|<0.05
72399657|NCT01203046|144306705|NON_INFERIORITY_OR_EQUIVALENCE|Consider a 5% confidence level, the power of assigned contrast was 80% to detect a difference minima of at least 10% of equivalence between the analyzed groups.|Odds Ratio (OR)|1.18|||<|0.05|TWO_SIDED|95.0|0.21|6.51|||Regression, Logistic|||||6.51|0.21|<0.05
72399658|NCT02293655|144306706|SUPERIORITY||Mean Difference (Final Values)|1.6|STANDARD_ERROR_OF_MEAN|2.6||0.55|TWO_SIDED||||||t-test, 2 sided|||Compared at Baseline Time point||||0.55
72399659|NCT02293655|144306706|SUPERIORITY||Mean Difference (Final Values)|2.41|STANDARD_ERROR_OF_MEAN|2.3||0.3|TWO_SIDED||||||t-test, 2 sided|||Comparison at MPH Maintenance Visit (Week 8)||||.30
72399660|NCT02293655|144306706|SUPERIORITY||Mean Difference (Final Values)|4.01|STANDARD_ERROR_OF_MEAN|3.9||0.28|TWO_SIDED||||||t-test, 2 sided|||Comparison at Randomization Phase 1 (Week 9)||||.28
72399661|NCT02293655|144306706|SUPERIORITY||Mean Difference (Final Values)|9.64|STANDARD_ERROR_OF_MEAN|2.5||0|TWO_SIDED||||||t-test, 2 sided|||Comparison at Randomization Phase 2 (Week 10)||||.00
72399662|NCT02293655|144306706|SUPERIORITY||Mean Difference (Final Values)|7.96|STANDARD_ERROR_OF_MEAN|3.2||0.01|TWO_SIDED||||||t-test, 2 sided|||Comparison at Randomization Phase 3 (Week 12)||||.01
72399663|NCT02293655|144306707|SUPERIORITY||Mean Difference (Final Values)|36.04|STANDARD_ERROR_OF_MEAN|25.4||0.32|TWO_SIDED||||||t-test, 2 sided|||Compared at baseline timepoint||||.32
72399664|NCT02293655|144306707|SUPERIORITY||Mean Difference (Final Values)|4.38|STANDARD_ERROR_OF_MEAN|30.1||0.9|TWO_SIDED||||||t-test, 2 sided|||Compared at Maintenance Time Point (week 8)||||.90
72477180|NCT02270515|144480201|SUPERIORITY_OR_OTHER|||||||0.77||||||This is the Burden KDQOL Subscale p-value for change in 6-12 months shown in Primary Outcome table 3.|Mixed Models Analysis|||"Burden:~From random-intercept linear mixed models with an AR(1) covariance pattern in the residual, adjusted for baseline age, sex, race (AA, all other), interview language, dialysis vintage (months), site, education (not HS grad, HS grad), marital status (married or living with partner, other), self-reported diabetes at baseline, PCP at baseline, urea reduction ratio (URR), hemoglobin (g/dL), and albumin (g/dL). The 3 lab values are time-varying covariates."||||0.77
72508628|NCT02064439|144548082|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.34||||0.4328|TWO_SIDED|95.0|0.65|2.75||P-value and hazard ratio estimates based on stratified proportional hazards model, with stratification based index event (DVT or PE with or without DVT).|Wald test|||Statistical analysis was performed on the first occurrence of the composite outcome.||2.75|0.65|0.4328
72399665|NCT02293655|144306707|SUPERIORITY||Mean Difference (Final Values)|100.81|STANDARD_ERROR_OF_MEAN|37.5||0.007|TWO_SIDED||||||t-test, 2 sided|||Compared at Randomization Phase 1 (week 9)||||.007
72399666|NCT02293655|144306707|SUPERIORITY||Mean Difference (Final Values)|49.07|STANDARD_ERROR_OF_MEAN|56.6||0.26|TWO_SIDED||||||t-test, 2 sided|||Compared at Randomization Phase 2 (week 10)||||.26
72399667|NCT02293655|144306707|SUPERIORITY||Mean Difference (Final Values)|123.9|STANDARD_ERROR_OF_MEAN|37.6||0.01|TWO_SIDED||||||t-test, 2 sided|||Compared at Randomization Phase 3 (week 12)||||.01
72399668|NCT02293655|144306708|SUPERIORITY||Mean Difference (Final Values)|31.13|STANDARD_ERROR_OF_MEAN|32.9||0.33|TWO_SIDED||||||t-test, 2 sided|||Comparison at Baseline||||.33
72399669|NCT02293655|144306708|SUPERIORITY||Mean Difference (Final Values)|56.86|STANDARD_ERROR_OF_MEAN|29.5||0.06|TWO_SIDED||||||t-test, 2 sided|||Comparison at Maintenance (week 8)||||.06
72399670|NCT02293655|144306708|SUPERIORITY||Mean Difference (Final Values)|108.78|STANDARD_ERROR_OF_MEAN|46.8||0.05|TWO_SIDED||||||t-test, 2 sided|||Comparison at Randomization Phase 1 (week 9)||||.05
72399671|NCT02293655|144306708|SUPERIORITY||Mean Difference (Final Values)|118.12|STANDARD_ERROR_OF_MEAN|44.2||0.008|TWO_SIDED||||||t-test, 2 sided|||Comparison at Randomization Phase 2 (week 10)||||.008
72399672|NCT02293655|144306708|SUPERIORITY||Mean Difference (Final Values)|77.09|STANDARD_ERROR_OF_MEAN|42.9||0.07|TWO_SIDED||||||t-test, 2 sided|||Comparison at Randomization Phase 3 (week 12)||||.07
72399673|NCT03814746|144306725|SUPERIORITY||Rate ratio|1.08|||>|0.999|TWO_SIDED|95.0|0.76|1.55|||negative binomial regression model|||||1.55|0.76|> 0.999
72508629|NCT02064439|144548083|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.01||||0.3235|TWO_SIDED|95.0|0.5|8.04||P-value and hazard ratio estimates based on stratified proportional hazards model, with stratification based index event (DVT or PE with or without DVT).|Wald test|||Statistical analysis was performed on the first occurrence of the composite outcome.||8.04|0.50|0.3235
72399674|NCT03814746|144306725|SUPERIORITY||Rate ratio|0.89|||>|0.999|TWO_SIDED|95.0|0.62|1.27|||negative binomial regression model|||||1.27|0.62|> 0.999
72508630|NCT02064439|144548083|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.64||||0.5005|TWO_SIDED|95.0|0.39|6.84||P-value and hazard ratio estimates based on stratified proportional hazards model, with stratification based index event (DVT or PE with or without DVT).|Wald test|||Statistical analysis was performed on the first occurrence of the composite outcome.||6.84|0.39|0.5005
72399675|NCT03814746|144306726|SUPERIORITY||Rate ratio|1.21|||||TWO_SIDED|95.0|0.87|1.7|||negative binomial regression model|||||1.70|0.87|
72399676|NCT03814746|144306726|SUPERIORITY||Rate ratio|0.83|||||TWO_SIDED|95.0|0.59|1.17|||negative binomial regression model|||||1.17|0.59|
72399677|NCT03814746|144306731|SUPERIORITY||Hazard Ratio (HR)|1.34|||||TWO_SIDED|95.0|0.92|1.97|||Cox Model|for time to first occurrence of VOC||||1.97|0.92|
72399678|NCT03814746|144306731|SUPERIORITY||Hazard Ratio (HR)|1.07|||||TWO_SIDED|95.0|0.72|1.58|||Cox Model|for time to first occurrence of VOC||||1.58|0.72|
72399679|NCT03814746|144306731|SUPERIORITY|for time to second occurrence of VOC|Hazard Ratio (HR)|1.29|||||TWO_SIDED|95.0|0.81|2.04|||Cox Model|||||2.04|0.81|
72399680|NCT03814746|144306731|SUPERIORITY||Hazard Ratio (HR)|0.95|||||TWO_SIDED|95.0|0.59|1.54|||Cox Model|for time to second occurrence of VOC||||1.54|0.59|
72399681|NCT03814746|144306732|SUPERIORITY||Rate ratio|1.03|||||TWO_SIDED|95.0|0.75|1.43|||Negative binomial regression model|for the Annualized rate of all visits to clinics, emergency rooms and hospitalizations||||1.43|0.75|
72399682|NCT03814746|144306732|SUPERIORITY||Rate ratio|0.82|||||TWO_SIDED|95.0|0.59|1.14|||Negative binomial regression model|for the Annualized rate of all visits to clinics, emergency rooms and hospitalizations||||1.14|0.59|
72399683|NCT03814746|144306732|SUPERIORITY||Rate ratio|1.11|||||TWO_SIDED|95.0|0.77|1.59|||Negative binomial regression model|for the Annualized rate of VOC-related visits to clinics, emergency rooms and hospitalizations||||1.59|0.77|
72399684|NCT03814746|144306732|SUPERIORITY||Rate ratio|0.87|||||TWO_SIDED|95.0|0.6|1.25|||Negative binomial regression model|for the Annualized rate of VOC-related visits to clinics, emergency rooms and hospitalizations||||1.25|0.60|
72399685|NCT03814746|144306733|SUPERIORITY||Rate ratio|1.34|||||TWO_SIDED|95.0|0.85|2.09|||Negative binomial regression model|for the Annualized days of all visits to clinics, emergency rooms and hospitalizations||||2.09|0.85|
72399686|NCT03814746|144306733|SUPERIORITY||Rate ratio|0.88|||||TWO_SIDED|95.0|0.57|1.38|||Negative binomial regression model|for the Annualized days of all visits to clinics, emergency rooms and hospitalizations||||1.38|0.57|
72477181|NCT02270515|144480201|SUPERIORITY_OR_OTHER|||||||0.77||||||This is the Symptoms KDQOL Subscale p-value for change in 6-12 months shown in Primary Outcome table 3.|Mixed Models Analysis|||"Symptoms:~From random-intercept linear mixed models with an AR(1) covariance pattern in the residual, adjusted for baseline age, sex, race (AA, all other), interview language, dialysis vintage (months), site, education (not HS grad, HS grad), marital status (married or living with partner, other), self-reported diabetes at baseline, PCP at baseline, urea reduction ratio (URR), hemoglobin (g/dL), and albumin (g/dL). The 3 lab values are time-varying covariates."||||0.77
72477182|NCT02270515|144480201|SUPERIORITY_OR_OTHER|||||||0.14||||||This is the Effects KDQOL Subscale p-value for change in 6-12 months shown in Primary Outcome table 3.|Mixed Models Analysis|||"Effects:~From random-intercept linear mixed models with an AR(1) covariance pattern in the residual, adjusted for baseline age, sex, race (AA, all other), interview language, dialysis vintage (months), site, education (not HS grad, HS grad), marital status (married or living with partner, other), self-reported diabetes at baseline, PCP at baseline, urea reduction ratio (URR), hemoglobin (g/dL), and albumin (g/dL). The 3 lab values are time-varying covariates."||||0.14
72477183|NCT02270515|144480201|SUPERIORITY_OR_OTHER|||||||0.45||||||This is the PCS KDQOL Subscale p-value for change in 12-18 months shown in Primary Outcome table 3.|Mixed Models Analysis|||"PCS:~From random-intercept linear mixed models with an AR(1) covariance pattern in the residual, adjusted for baseline age, sex, race (AA, all other), interview language, dialysis vintage (months), site, education (not HS grad, HS grad), marital status (married or living with partner, other), self-reported diabetes at baseline, PCP at baseline, urea reduction ratio (URR), hemoglobin (g/dL), and albumin (g/dL). The 3 lab values are time-varying covariates."||||0.45
72477184|NCT02270515|144480201|SUPERIORITY_OR_OTHER|||||||0.79||||||This is the MCS KDQOL Subscale p-value for change in 12-18 months shown in Primary Outcome table 3.|Mixed Models Analysis|||"MCS:~From random-intercept linear mixed models with an AR(1) covariance pattern in the residual, adjusted for baseline age, sex, race (AA, all other), interview language, dialysis vintage (months), site, education (not HS grad, HS grad), marital status (married or living with partner, other), self-reported diabetes at baseline, PCP at baseline, urea reduction ratio (URR), hemoglobin (g/dL), and albumin (g/dL). The 3 lab values are time-varying covariates."||||0.79
72477185|NCT02270515|144480201|SUPERIORITY_OR_OTHER|||||||0.77||||||This is the Burden KDQOL Subscale p-value for change in 12-18 months shown in Primary Outcome table 3.|Mixed Models Analysis|||"Burden:~From random-intercept linear mixed models with an AR(1) covariance pattern in the residual, adjusted for baseline age, sex, race (AA, all other), interview language, dialysis vintage (months), site, education (not HS grad, HS grad), marital status (married or living with partner, other), self-reported diabetes at baseline, PCP at baseline, urea reduction ratio (URR), hemoglobin (g/dL), and albumin (g/dL). The 3 lab values are time-varying covariates."||||0.77
72477186|NCT02270515|144480201|SUPERIORITY_OR_OTHER|||||||0.03||||||This is the Symptoms KDQOL Subscale p-value for change in 12-18 months shown in Primary Outcome table 3.|Mixed Models Analysis|||"Symptoms:~From random-intercept linear mixed models with an AR(1) covariance pattern in the residual, adjusted for baseline age, sex, race (AA, all other), interview language, dialysis vintage (months), site, education (not HS grad, HS grad), marital status (married or living with partner, other), self-reported diabetes at baseline, PCP at baseline, urea reduction ratio (URR), hemoglobin (g/dL), and albumin (g/dL). The 3 lab values are time-varying covariates."||||0.03
72477187|NCT02270515|144480201|SUPERIORITY_OR_OTHER|||||||0.12||||||This is the Effects KDQOL Subscale p-value for change in 12-18 months shown in Primary Outcome table 3.|Mixed Models Analysis|||"Effects:~From random-intercept linear mixed models with an AR(1) covariance pattern in the residual, adjusted for baseline age, sex, race (AA, all other), interview language, dialysis vintage (months), site, education (not HS grad, HS grad), marital status (married or living with partner, other), self-reported diabetes at baseline, PCP at baseline, urea reduction ratio (URR), hemoglobin (g/dL), and albumin (g/dL). The 3 lab values are time-varying covariates."||||0.12
72508631|NCT02064439|144548083|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.23||||0.7337|TWO_SIDED|95.0|0.37|4.03||P-value and hazard ratio estimates based on stratified proportional hazards model, with stratification based index event (DVT or PE with or without DVT).|Wald test|||Statistical analysis was performed on the first occurrence of the composite outcome.||4.03|0.37|0.7337
72508632|NCT02064439|144548084|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.34|||<|0.0001|TWO_SIDED|95.0|0.2|0.57||P-value and hazard ratio estimates based on stratified proportional hazards model, with stratification based index event (DVT or PE with or without DVT).|Wald test|||Statistical analysis was performed on the first occurrence of the composite outcome.||0.57|0.20|<0.0001
72508633|NCT02064439|144548084|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.32|||<|0.0001|TWO_SIDED|95.0|0.19|0.54||P-value and hazard ratio estimates based on stratified proportional hazards model, with stratification based index event (DVT or PE with or without DVT).|Wald test|||Statistical analysis was performed on the first occurrence of the composite outcome.||0.54|0.19|<0.0001
72508634|NCT02064439|144548084|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.08||||0.8172|TWO_SIDED|95.0|0.57|2.06||P-value and hazard ratio estimates based on stratified proportional hazards model, with stratification based index event (DVT or PE with or without DVT).|Wald test|||Statistical analysis was performed on the first occurrence of the composite outcome.||2.06|0.57|0.8172
72566390|NCT02697773|144663267|SUPERIORITY||Odds Ratio (OR)|2.01||||0.0004|TWO_SIDED|95.0|1.36|2.96|||Regression, Logistic|||Week 12, \>=30%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.96|1.36|0.0004
72399687|NCT03814746|144306733|SUPERIORITY||Rate ratio|1.27|||||TWO_SIDED|95.0|0.77|2.09|||Negative binomial regression model|for the Annualized days of VOC-related visits to clinics, emergency rooms and hospitalizations||||2.09|0.77|
72399688|NCT03814746|144306733|SUPERIORITY||Rate ratio|0.87|||||TWO_SIDED|95.0|0.52|1.44|||Negative binomial regression model|for the Annualized days of VOC-related visits to clinics, emergency rooms and hospitalizations||||1.44|0.52|
72477188|NCT02270515|144480201|SUPERIORITY_OR_OTHER|||||||0.29||||||This is the PCS KDQOL Subscale p-value for change in 0-18 months shown in Primary Outcome table 3.|Mixed Models Analysis|||"PCS:~From random-intercept linear mixed models with an AR(1) covariance pattern in the residual, adjusted for baseline age, sex, race (AA, all other), interview language, dialysis vintage (months), site, education (not HS grad, HS grad), marital status (married or living with partner, other), self-reported diabetes at baseline, PCP at baseline, urea reduction ratio (URR), hemoglobin (g/dL), and albumin (g/dL). The 3 lab values are time-varying covariates."||||0.29
72477189|NCT02270515|144480201|SUPERIORITY_OR_OTHER|||||||0.01||||||This is the MCS KDQOL Subscale p-value for change in 0-18 months shown in Primary Outcome table 3.|Mixed Models Analysis|||"MCS:~From random-intercept linear mixed models with an AR(1) covariance pattern in the residual, adjusted for baseline age, sex, race (AA, all other), interview language, dialysis vintage (months), site, education (not HS grad, HS grad), marital status (married or living with partner, other), self-reported diabetes at baseline, PCP at baseline, urea reduction ratio (URR), hemoglobin (g/dL), and albumin (g/dL). The 3 lab values are time-varying covariates."||||0.01
72477190|NCT02270515|144480201|SUPERIORITY_OR_OTHER|||||||0.08||||||This is the Burden KDQOL Subscale p-value for change in 0-18 months shown in Primary Outcome table 3.|Mixed Models Analysis|||"Burden:~From random-intercept linear mixed models with an AR(1) covariance pattern in the residual, adjusted for baseline age, sex, race (AA, all other), interview language, dialysis vintage (months), site, education (not HS grad, HS grad), marital status (married or living with partner, other), self-reported diabetes at baseline, PCP at baseline, urea reduction ratio (URR), hemoglobin (g/dL), and albumin (g/dL). The 3 lab values are time-varying covariates."||||0.08
72477191|NCT02270515|144480201|SUPERIORITY_OR_OTHER|||||||0.61||||||This is the Symptoms KDQOL Subscale p-value for change in 0-18 months shown in Primary Outcome table 3.|Mixed Models Analysis|||"Symptoms:~From random-intercept linear mixed models with an AR(1) covariance pattern in the residual, adjusted for baseline age, sex, race (AA, all other), interview language, dialysis vintage (months), site, education (not HS grad, HS grad), marital status (married or living with partner, other), self-reported diabetes at baseline, PCP at baseline, urea reduction ratio (URR), hemoglobin (g/dL), and albumin (g/dL). The 3 lab values are time-varying covariates."||||0.61
72477192|NCT02270515|144480201|SUPERIORITY_OR_OTHER|||||||0.02||||||This is the Effects KDQOL Subscale p-value for change in 0-18 months shown in Primary Outcome table 3.|Mixed Models Analysis|||"Effects:~From random-intercept linear mixed models with an AR(1) covariance pattern in the residual, adjusted for baseline age, sex, race (AA, all other), interview language, dialysis vintage (months), site, education (not HS grad, HS grad), marital status (married or living with partner, other), self-reported diabetes at baseline, PCP at baseline, urea reduction ratio (URR), hemoglobin (g/dL), and albumin (g/dL). The 3 lab values are time-varying covariates."||||0.02
72477193|NCT00911768|144480207|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.181|STANDARD_ERROR_OF_MEAN|0.416|<|0.05||95.0|-0.647|1.008|||t-test, 2 sided|||||1.008|-0.647|<0.05
72477194|NCT00911768|144480208|NON_INFERIORITY_OR_EQUIVALENCE|A non-inferiority analysis was conducted. We just compared the difference of stimulated salivary rates between both groups at 8 weeks, because there were no definition of the effective margin.|Mean Difference (Final Values)|-0.346|STANDARD_ERROR_OF_MEAN|0.116|<|0.05||95.0|-0.576|-0.115|||t-test, 2 sided|||||-0.115|-0.576|<0.05
72477195|NCT00911768|144480209|NON_INFERIORITY_OR_EQUIVALENCE|A non-inferiority analysis was conducted. We just compared the difference of unstimulated salivary rates between both groups at 8 weeks, because there were no definition of the effective margin.|Mean Difference (Final Values)|-0.086|STANDARD_ERROR_OF_MEAN|0.035|<|0.05||95.0|-0.155|-0.017|||t-test, 2 sided|||||-0.017|-0.155|<0.05
72477196|NCT00467350|144480210|SUPERIORITY_OR_OTHER_LEGACY|"Similar to previous studies, the main outcome measure was the change in the child's main symptom. Changes were determined by the question Has your child's main symptom improved, stayed the same or gotten worse? The main symptom was defined as the chief complaint identified during the triage process. For analysis, responses were dichotomized into 2 groups: improved/better versus worse/same."|||||||||||||||||A χ2 test was used to examine the difference in probabilities of experiencing an outcome between treatment arms and differences were expressed by Mantel-Haenszel common OR estimate with 95% confidence interval (CI).|||
72508635|NCT02064439|144548085|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.44||||0.3318|TWO_SIDED|95.0|0.69|3.02||P-value and hazard ratio estimates based on stratified proportional hazards model, with stratification based index event (DVT or PE with or without DVT).|Wald test|||||3.02|0.69|0.3318
72508636|NCT02064439|144548085|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.99||||0.9726|TWO_SIDED|95.0|0.44|2.2||P-value and hazard ratio estimates based on stratified proportional hazards model, with stratification based index event (DVT or PE with or without DVT).|Wald test|||||2.20|0.44|0.9726
72477197|NCT03538301|144480212|SUPERIORITY||Slope|-0.004153||||0.049|TWO_SIDED|95.0|-0.008284|-0.000021|||random coefficient model|||Slope in FVC (L/week) in the 45 mg cohort versus placebo||-0.000021|-0.008284|0.049
72477198|NCT03538301|144480212|SUPERIORITY||Slope|-0.002112||||0.316|TWO_SIDED|95.0|-0.00626|0.002036|||random coefficient model|||Slope in FVC (L/week) in the 90 mg cohort versus placebo||0.002036|-0.006260|0.316
72477199|NCT03538301|144480213|SUPERIORITY||Slope|-0.091238||||0.098|TWO_SIDED|95.0|-0.199456|0.016979|||random coefficient model|||||0.016979|-0.199456|0.098
72508637|NCT02064439|144548085|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.46||||0.3137|TWO_SIDED|95.0|0.7|3.06||P-value and hazard ratio estimates based on stratified proportional hazards model, with stratification based index event (DVT or PE with or without DVT).|Wald test|||||3.06|0.70|0.3137
72508638|NCT02262039|144548124|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
72508639|NCT02262039|144548125|SUPERIORITY_OR_OTHER|||||||0.92|||||||t-test, 2 sided|||||||0.92
72508640|NCT02262039|144548126|SUPERIORITY_OR_OTHER|||||||0.78|||||||t-test, 2 sided|||||||0.78
72508641|NCT02262039|144548127|SUPERIORITY_OR_OTHER|||||||0.52|||||||t-test, 2 sided|||||||0.52
72508642|NCT02262039|144548128|SUPERIORITY_OR_OTHER|||||||0.25|||||||t-test, 2 sided|||||||0.25
72508643|NCT02262039|144548129|SUPERIORITY_OR_OTHER|||||||0.82|||||||t-test, 2 sided|||||||0.82
72508644|NCT02262039|144548130|SUPERIORITY_OR_OTHER|||||||0.45|||||||t-test, 2 sided|||||||0.45
72508645|NCT04174638|144548131|SUPERIORITY||||||<|0.001||||||The threshold for statistical significance was p=0.05. The p value was the value of the total score of the Fluid Control in Hemodialysis Patients Scale.|t-test, 2 sided|||||||<0.001
72508646|NCT04174638|144548132|SUPERIORITY||||||<|0.001||||||The threshold for statistical significance was p=0.05.|t-test, 2 sided|||||||<0.001
72477200|NCT03538301|144480213|SUPERIORITY||Slope|-0.039596||||0.473|TWO_SIDED|95.0|-0.148248|0.069056|||random coefficient model|||||0.069056|-0.148248|0.473
72477201|NCT03538301|144480214|SUPERIORITY||Mean Difference (Final Values)|-0.0997||||0.049|TWO_SIDED|95.0|-0.1988|-0.0005|||random coefficient model|||Change from Baseline to Week 24 in FVC (L) in the 45 mg cohort versus placebo||-0.0005|-0.1988|0.049
72477202|NCT03538301|144480214|SUPERIORITY||Mean Difference (Final Values)|-0.0507||||0.316|TWO_SIDED|95.0|-0.1502|0.0489|||random coefficient model|||Change from Baseline to Week 24 in FVC (L) in the 90 mg cohort versus placebo||0.0489|-0.1502|0.316
72477203|NCT03538301|144480215|SUPERIORITY||Median Difference (Final Values)|-3.16||||0.668|TWO_SIDED|95.0|-17.59|11.28|||random coefficient model|||||11.28|-17.59|0.668
72477204|NCT03538301|144480215|SUPERIORITY||Median Difference (Final Values)|-1.72||||0.821|TWO_SIDED|95.0|-16.57|13.13|||random coefficient model|||||13.13|-16.57|0.821
72477205|NCT03538301|144480216|SUPERIORITY||Median Difference (Final Values)|-2.1897||||0.098|TWO_SIDED|95.0|-4.7869|0.4075|||random coefficient model|||Change from baseline to Week 24 in ppFVC||0.4075|-4.7869|0.098
72508647|NCT04174638|144548133|SUPERIORITY||||||<|0.001||||||The threshold for statistical significance was p=0.05.|t-test, 2 sided|||It was calculated for detect of difference in mean the knowledge sub-dimension score of Modified Morisky Scale between intervention and control group from baseline to week 12.||||<0.001
72508648|NCT04174638|144548133|SUPERIORITY||||||<|0.001||||||The threshold for statistical significance was p=0.05.|t-test, 2 sided|||It was calculated for detect of difference in mean the motivation sub-dimension score of Modified Morisky Scale between intervention and control group from baseline to week 12.||||<0.001
72477206|NCT03538301|144480216|SUPERIORITY||Median Difference (Final Values)|-0.9503||||0.473|TWO_SIDED|95.0|-3.5579|1.6573|||random coefficient model|||Change from Baseline to Week 24 in ppFVC||1.6573|-3.5579|0.473
72477207|NCT03538301|144480217|SUPERIORITY||Median Difference (Final Values)|-2.53||||0.7|TWO_SIDED|95.0|-15.4|10.34|||random coefficient model|||||10.34|-15.40|0.700
72477208|NCT03538301|144480217|SUPERIORITY||Median Difference (Final Values)|-1.12||||0.867|TWO_SIDED|95.0|-14.31|12.07|||random coefficient model|||||12.07|-14.31|0.867
72477209|NCT03538301|144480220|SUPERIORITY||Mean Difference (Final Values)|0.146||||0.708|TWO_SIDED|95.0|-0.6226|0.9147|||random coefficient|||Change from Baseline to Week 24 in DLCO Corrected for Hemoglobin (mL/min/mmHg) in the 45 mg cohort versus placebo||0.9147|-0.6226|0.708
72477210|NCT03538301|144480220|SUPERIORITY||Mean Difference (Final Values)|0.7038||||0.074|TWO_SIDED|95.0|-0.0695|1.4771|||random coefficient|||Change from Baseline to Week 24 in DLCO Corrected for Hemoglobin (mL/min/mmHg) in the 90 mg cohort versus placebo||1.4771|-0.0695|0.074
72508649|NCT04174638|144548137|SUPERIORITY|||||||0.297||||||The threshold for statistical significance was p=0.05.|t-test, 2 sided|||It was calculated for detect of difference in mean the physical functions sub-dimension score of Kidney Disease Quality of Life Instrument 36 Scale between intervention and control group from baseline to week 12.||||0.297
72508650|NCT04174638|144548137|SUPERIORITY|||||||0.742||||||The threshold for statistical significance was p=0.05|t-test, 2 sided|||It was calculated for detect of difference in mean the mental functions sub-dimension score of Kidney Disease Quality of Life Instrument 36 Scale between intervention and control group from baseline to week 12.||||0.742
72508651|NCT04174638|144548137|SUPERIORITY|||||||0.719||||||The threshold for statistical significance was p=0.05.|t-test, 2 sided|||It was calculated for detect of difference in mean the burden of kidney disease sub-dimension score of Kidney Disease Quality of Life Instrument 36 Scale between intervention and control group from baseline to week 12.||||0.719
72477211|NCT03538301|144480220|SUPERIORITY||Mean Difference (Final Values)|0.114||||0.765|TWO_SIDED|95.0|-0.6362|0.8641|||random coefficient model|||Change from Baseline to Week 24 in DLCO Not Corrected for Hemoglobin (mL/min/mmHg) in the 45 mg cohort versus placebo||0.8641|-0.6362|0.765
72508652|NCT04174638|144548137|SUPERIORITY|||||||0.063||||||The threshold for statistical significance was p=0.05|t-test, 2 sided|||It was calculated for detect of difference in mean the symptoms/problems sub-dimension score of Kidney Disease Quality of Life Instrument 36 Scale between intervention and control group from baseline to week 12.||||0.063
72477212|NCT03538301|144480220|SUPERIORITY||Mean Difference (Final Values)|0.556||||0.148|TWO_SIDED|95.0|-0.1986|1.3107|||random coefficient model|||Change from Baseline to Week 24 in DLCO Not Corrected for Hemoglobin (mL/min/mmHg) in the 90 mg cohort versus placebo||1.3107|-0.1986|0.148
72477213|NCT03538301|144480221|SUPERIORITY||Mean Difference (Final Values)|-0.48||||0.765|TWO_SIDED|95.0|-3.68|2.71|||random coefficient model|||Change from Baseline to Week 24 in QLF Score (% of whole lung field volume) in the 45 mg cohort versus placebo||2.71|-3.68|0.765
72477214|NCT03538301|144480221|SUPERIORITY||Mean Difference (Final Values)|1.4||||0.37|TWO_SIDED|95.0|-1.68|4.47|||random coefficient model|||Change from Baseline to Week 24 in QLF Score (% of whole lung field volume) in the 90 mg cohort versus placebo||4.47|-1.68|0.370
72477215|NCT03538301|144480221|SUPERIORITY||Mean Difference (Final Values)|-0.18||||0.499|TWO_SIDED|95.0|-0.7|0.34|||random coefficient model|||Change from Baseline to Week 24 in Ground Glass Opacity (% of whole lung field volume) in the 45 mg cohort versus placebo||0.34|-0.70|0.499
72477216|NCT03538301|144480221|SUPERIORITY||Mean Difference (Final Values)|0.03||||0.901|TWO_SIDED|95.0|-0.47|0.54|||random coefficient model|||Change from Baseline to Week 24 in Ground Glass Opacity (% of whole lung field volume) in the 90 mg cohort versus placebo||0.54|-0.47|0.901
72477217|NCT03538301|144480221|SUPERIORITY||Mean Difference (Final Values)|0.6||||0.676|TWO_SIDED|95.0|-2.25|3.46|||random coefficient model|||Change from Baseline to Week 24 in Reticulation (% of whole lung field volume) in the 45 mg cohort versus placebo||3.46|-2.25|0.676
72477218|NCT03538301|144480221|SUPERIORITY||Mean Difference (Final Values)|1.64||||0.242|TWO_SIDED|95.0|-1.13|4.42|||random coefficient model|||Change from Baseline to Week 24 in Reticulation (% of whole lung field volume) in the 90 mg cohort versus placebo||4.42|-1.13|0.242
72477219|NCT03538301|144480221|SUPERIORITY||Mean Difference (Final Values)|-1.21||||0.14|TWO_SIDED|95.0|-2.82|0.4|||random coefficient model|||Change from Baseline to Week 24 in Honeycombing (% of whole lung field volume) in the 45 mg cohort versus placebo||0.40|-2.82|0.140
72477220|NCT03538301|144480221|SUPERIORITY||Mean Difference (Final Values)|-0.98||||0.211|TWO_SIDED|95.0|-2.53|0.56|||random coefficient model|||Change from Baseline to Week 24 in Honeycombing (% of whole lung field volume) in the 90 mg cohort versus placebo||0.56|-2.53|0.211
72477221|NCT03538301|144480221|SUPERIORITY||Mean Difference (Final Values)|0.88||||0.568|TWO_SIDED|95.0|-2.16|3.91|||random coefficient model|||Change from Baseline to Week 24 in Normal Lung (% of whole lung field volume) in the 45 mg cohort versus placebo||3.91|-2.16|0.568
72566391|NCT02697773|144663267|SUPERIORITY||Odds Ratio (OR)|2.64|||<|0.0001|TWO_SIDED|95.0|1.78|3.93|||Regression, Logistic|||Week 12, \>=30%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.93|1.78|<.0001
72477222|NCT03538301|144480221|SUPERIORITY||Mean Difference (Final Values)|-0.83||||0.573|TWO_SIDED|95.0|-3.76|2.09|||random coefficient model|||Change from Baseline to Week 24 in Normal Lung (% of whole lung field volume) in the 90 mg cohort versus placebo||2.09|-3.76|0.573
72508653|NCT04174638|144548137|SUPERIORITY||||||<|0.001||||||The threshold for statistical significance was p=0.05.|t-test, 2 sided|||It was calculated for detect of difference in mean the effects of kidney disease on daily life sub-dimension score of Kidney Disease Quality of Life Instrument 36 Scale between intervention and control group from baseline to week 12.||||<0.001
72508654|NCT00321984|144548142|SUPERIORITY_OR_OTHER||||||<|1e-05||||||The overall 0.0025 level of significance for the multiple comparisons of each dexlansoprazole MR dose to placebo was controlled using Hochberg's method.|Wilcoxon (Mann-Whitney)|||The comparison between the two treatment groups was made using Wilcoxon rank-sum test.||||<0.00001
72508655|NCT00321984|144548142|SUPERIORITY_OR_OTHER||||||<|1e-05||||||The overall 0.0025 level of significance for the multiple comparisons of each dexlansoprazole MR dose to placebo was controlled using Hochberg's method.|Wilcoxon (Mann-Whitney)|||The comparison between the two treatment groups was made using Wilcoxon rank-sum test.||||<0.00001
72508656|NCT00321984|144548142|SUPERIORITY_OR_OTHER|||||||0.72941||||||Statistical significance was determined at 0.0025 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||The comparison between the two treatment groups was made using Wilcoxon rank-sum test.||||0.72941
72508657|NCT00321984|144548144|SUPERIORITY_OR_OTHER||||||<|1e-05||||||The overall 0.0025 level of significance for the multiple comparisons of each dexlansoprazole MR dose to placebo was controlled using Hochberg's method.|Wilcoxon (Mann-Whitney)|||The comparison between the two treatment groups was made using Wilcoxon rank-sum test.||||<0.00001
72508658|NCT00321984|144548144|SUPERIORITY_OR_OTHER||||||<|1e-05||||||The overall 0.0025 level of significance for the multiple comparisons of each dexlansoprazole MR dose to placebo was controlled using Hochberg's method.|Wilcoxon (Mann-Whitney)|||The comparison between the two treatment groups was made using Wilcoxon rank-sum test.||||<0.00001
72508659|NCT00321984|144548144|SUPERIORITY_OR_OTHER|||||||0.3146||||||Statistical significance was determined at 0.0025 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||The comparison between the two treatment groups was made using Wilcoxon rank-sum test.||||0.31460
72508660|NCT00739297|144548146|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least-Squares Means|0.04||||||95.0|-0.01|0.08|||||Mixed effects model with terms for treatment (including dose of montelukast), period and baseline covariate.|||0.08|-0.01|
72508661|NCT00739297|144548146|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least-Squares Means|0.1||||||95.0|0.04|0.15|||||Mixed effects model with terms for treatment (including dose of montelukast), period and baseline covariate.|||0.15|0.04|
72508662|NCT00739297|144548146|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least-Squares Means|0.06||||||95.0|0.02|0.11|||||Mixed effects model with terms for treatment (including dose of montelukast), period and baseline covariate.|||0.11|0.02|
72508663|NCT00739297|144548146|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least-Squares Means|0.05||||||95.0|-0.01|0.11|||||Mixed effects model with terms for treatment (including dose of montelukast), period and baseline covariate.|||0.11|-0.01|
72508664|NCT00739297|144548146|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least-Squares Means|0.08||||||95.0|0.04|0.13|||||Mixed effects model with terms for treatment (including dose of montelukast), period and baseline covariate.|||0.13|0.04|
72477223|NCT03538301|144480221|SUPERIORITY||Mean Difference (Final Values)|-3.58||||0.012|TWO_SIDED|95.0|-6.35|-0.81|||random coefficient model|||Change from Baseline to Week 24 in Emphysema (% of whole lung field volume) in the 45 mg cohort versus placebo||-0.81|-6.35|0.012
72477224|NCT03538301|144480221|SUPERIORITY||Mean Difference (Final Values)|-2.16||||0.112|TWO_SIDED|95.0|-4.82|0.51|||random coefficient model|||Change from Baseline to Week 24 in Emphysema (% of whole lung field volume) in the 90 mg cohort versus placebo||0.51|-4.82|0.112
72477225|NCT03538301|144480222|SUPERIORITY|||||||0.256|||||||Wilcoxon (Mann-Whitney)|||||||0.256
72508665|NCT00739297|144548147|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least-Squares Means|0.19||||||95.0|0.04|0.34|||||Repeated measures model with terms for treatment (Albuterol/Placebo), dose, treatment-by-dose interaction and baseline FEV1|||0.34|0.04|
72508666|NCT00739297|144548148|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least-Squares Means|0.06||||||95.0|-0.01|0.12|||||Mixed effects model with terms for treatment (including dose of montelukast), period and baseline covariate.|||0.12|-0.01|
72566392|NCT02697773|144663267|SUPERIORITY||Odds Ratio (OR)|2.11||||0.0001|TWO_SIDED|95.0|1.44|3.09|||Regression, Logistic|||Week 12, \>=50%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.09|1.44|0.0001
72477226|NCT03538301|144480222|SUPERIORITY|||||||0.241|||||||Wilcoxon (Mann-Whitney)|||||||0.241
72477227|NCT03538301|144480223|SUPERIORITY||Hazard Ratio (HR)|0.649||||0.517|TWO_SIDED|95.0|0.189|2.225|||Log Rank|||Time to First IPF Exacerbation or Death (weeks) in the 45 mg cohort versus placebo||2.225|0.189|0.517
72477228|NCT03538301|144480223|SUPERIORITY||Hazard Ratio (HR)|0.678||||0.506|TWO_SIDED|95.0|0.198|2.324|||Log Rank|||Time to First IPF Exacerbation or Death (weeks) in the 90 mg cohort versus placebo||2.324|0.198|0.506
72477229|NCT03538301|144480223|SUPERIORITY||Proportion Difference (Final Values)|-9.3||||0.313|TWO_SIDED|95.0|-25.2|5.5|||Fisher Exact||The 95% Confidence Interval for difference in proportions are based on the Chan-Zhang method.|Rate of First IPF Exacerbation (%) in the 45 mg cohort versus placebo||5.5|-25.2|0.313
72477230|NCT03538301|144480223|SUPERIORITY|The 95% Confidence Interval for difference in proportions are based on the Chan-Zhang method.|Proportion Difference (Final Values)|-6.7||||0.376|TWO_SIDED|95.0|-22.6|9.2|||Chi-squared|||Rate of First IPF Exacerbation (%) in the 90 mg cohort versus placebo||9.2|-22.6|0.376
72508667|NCT00739297|144548148|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least-Squares Means|0.07||||||95.0|0.0|0.15|||||Mixed effects model with terms for treatment (including dose of montelukast), period and baseline covariate.|||0.15|-0.00|
72508668|NCT00739297|144548148|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least-Squares Means|0.05||||||95.0|-0.01|0.11|||||Mixed effects model with terms for treatment (including dose of montelukast), period and baseline covariate.|||0.11|-0.01|
72508669|NCT00739297|144548148|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least-Squares Means|0.06||||||95.0|-0.03|0.14|||||Mixed effects model with terms for treatment (including dose of montelukast), period and baseline covariate.|||0.14|-0.03|
72508670|NCT00739297|144548148|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least-Squares Means|0.08||||||95.0|0.01|0.15|||||Mixed effects model with terms for treatment (including dose of montelukast), period and baseline covariate.|||0.15|0.01|
72508671|NCT00739297|144548149|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least-Squares Means|0.04||||||95.0|-0.03|0.1|||||Mixed effects model with terms for treatment (including dose of montelukast), period and baseline covariate.|||0.10|-0.03|
72508672|NCT00739297|144548149|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least-Squares Means|0.09||||||95.0|0.01|0.17|||||Mixed effects model with terms for treatment (including dose of montelukast), period and baseline covariate.|||0.17|0.01|
72399689|NCT02278263|144306766|SUPERIORITY||||||<|0.05|||||||ANOVA|||Assuming a common standard deviation of 412 mL, to detect a difference of 300 mL of blood loss between the two treatment arms (sTXA and tTXA) and the placebo group, a sample size of 125 participants is required for a statistical power of 0.85, and a type I error of 0.05. The sample size required was 125 participants in total. The was increased by 15% to allow for expected dropouts. Therefore, a minimum of 147 patients was required for the study.||||<0.05
72477231|NCT03538301|144480224|SUPERIORITY||Proportion Difference (Final Values)|-4.6||||0.713|TWO_SIDED|95.0|-19.2|9.6|||Fisher Exact||The 95% Confidence Interval for difference in proportions are based on the Chan-Zhang method.|Rate of Hospitalization for Respiratory Ailments (%) in the 45 mg cohort versus placebo||9.6|-19.2|0.713
72566393|NCT02697773|144663267|SUPERIORITY||Odds Ratio (OR)|2.08||||0.0002|TWO_SIDED|95.0|1.42|3.04|||Regression, Logistic|||Week 12, \>=50%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.04|1.42|0.0002
72477232|NCT03538301|144480224|SUPERIORITY||Proportion Difference (Final Values)|-4.4||||0.713|TWO_SIDED|95.0|-19.2|10.7|||Fisher Exact||The 95% Confidence Interval for difference in proportions are based on the Chan-Zhang method.|Rate of Hospitalization for Respiratory Ailments (%) in the 90 mg cohort versus placebo||10.7|-19.2|0.713
72477233|NCT03538301|144480225|SUPERIORITY|||||||0.937|||||||Log Rank|||Overall Survival (weeks) in the 45 mg cohort versus placebo||||0.937
72477234|NCT03538301|144480225|SUPERIORITY|||||||0.414|||||||Log Rank|||Overall Survival (weeks) in the 90 mg cohort versus placebo||||0.414
72477235|NCT03538301|144480225|SUPERIORITY||Proportion Difference (Final Values)|0.1|||>|0.999|TWO_SIDED|95.0|-10.4|10.9|||Fisher Exact||The 95% Confidence Interval for difference in proportions are based on the Chan-Zhang method.|Rate of Mortality (%) in the 45 mg cohort versus placebo||10.9|-10.4|>0.999
72508673|NCT00739297|144548149|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least-Squares Means|0.05||||||95.0|-0.01|0.1|||||Mixed effects model with terms for treatment (including dose of montelukast), period and baseline covariate.|||0.10|-0.01|
72477236|NCT03538301|144480225|SUPERIORITY||Proportion Difference (Final Values)|-2.4|||>|0.999|TWO_SIDED|95.0|-13.1|6.8|||Fisher Exact||The 95% Confidence Interval for difference in proportions are based on the Chan-Zhang method.|Rate of Mortality (%) in the 90 mg cohort versus placebo||6.8|-13.1|>0.999
72477237|NCT03538301|144480226|SUPERIORITY||Proportion Difference (Final Values)|-4.8||||0.494|TWO_SIDED|95.0|-16.6|4.6|||Fisher Exact||The 95% Confidence Interval for difference in proportions are based on the Chan-Zhang method.|Rate of Deterioration of IPF Resulting in Lung Transplantation (%) in the 45 mg cohort versus placebo||4.6|-16.6|0.494
72477238|NCT03538301|144480226|SUPERIORITY||Proportion Difference (Final Values)|-4.8||||0.494|TWO_SIDED|95.0|-16.2|4.5|||Fisher Exact||The 95% Confidence Interval for difference in proportions are based on the Chan-Zhang method.|Rate of Deterioration of IPF Resulting in Lung Transplantation (%) in the 90 mg cohort versus placebo||4.5|-16.2|0.494
72508674|NCT00739297|144548149|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least-Squares Means|0.07||||||95.0|-0.02|0.15|||||Mixed effects model with terms for treatment (including dose of montelukast), period and baseline covariate.|||0.15|-0.02|
72508675|NCT00739297|144548149|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least-Squares Means|0.08||||||95.0|0.01|0.15|||||Mixed effects model with terms for treatment (including dose of montelukast), period and baseline covariate.|||0.15|0.01|
72566394|NCT02697773|144663267|SUPERIORITY||Odds Ratio (OR)|2.13||||0.0003|TWO_SIDED|95.0|1.41|3.23|||Regression, Logistic|||Week 12, \>=70%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.23|1.41|0.0003
72477239|NCT02842151|144480243|EQUIVALENCE|Difference in A-Constant is manifest refraction minus autorefraction. The criteria for equivalence (based on paired difference t-test) was established if the bounds of the 90% two-sided confidence interval (CI) on the difference was contained within the equivalence range (-0.15, 0.15).|Mean Difference (Final Values)|0.05|STANDARD_DEVIATION|0.346|||TWO_SIDED|90.0|-0.03|0.13||||||To demonstrate equivalency at Site 1, A-constant with manifest refraction was compared to A-constant with autorefraction.||0.13|-0.03|
72477240|NCT02842151|144480243|EQUIVALENCE|Difference in A-Constant is manifest refraction minus autorefraction. The criteria for equivalence (based on paired difference t-test) was established if the bounds of the 90% two-sided confidence interval (CI) on the difference was contained within the equivalence range (-0.15, 0.15).|Mean Difference (Net)|-0.07|STANDARD_DEVIATION|0.595|||TWO_SIDED|90.0|-0.21|0.07||||||To demonstrate equivalency at Site 2, A-constant with manifest refraction was compared to A-constant with autorefraction.||0.07|-0.21|
72508676|NCT01757704|144548152|SUPERIORITY_OR_OTHER||Median Difference (Net)|56.0|||<|0.01||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.01
72508677|NCT02749721|144548158|OTHER||||||<|0.001|||||||Paired t-test|||||||<0.001
72508678|NCT02749721|144548159|OTHER|||||||0.012|||||||Paired t-test|||||||0.012
72508679|NCT02749721|144548160|OTHER||Pearson's R|0.125||||0.61|TWO_SIDED||||||Pearson's correlation|||Correlation between MADRS and AOB P200 (amplitude) baseline scores||||0.610
72508680|NCT02749721|144548160|OTHER||Pearson's R|-0.294||||0.288|TWO_SIDED||||||Pearson's correlation|||Correlation between MADRS and AOB P3a (amplitude) baseline scores||||0.288
72508681|NCT02749721|144548160|OTHER||Pearson's R|-0.405||||0.134|TWO_SIDED||||||Pearson's correlation|||Correlation between MADRS and AOB P3b (amplitude) baseline scores||||0.134
72477241|NCT02842151|144480243|EQUIVALENCE|Difference in A-Constant is manifest refraction minus autorefraction. The criteria for equivalence (based on paired difference t-test) was established if the bounds of the 90% two-sided confidence interval (CI) on the difference was contained within the equivalence range (-0.15, 0.15).|Mean Difference (Net)|-0.13|STANDARD_DEVIATION|0.34|||TWO_SIDED|90.0|-0.22|-0.04||||||To demonstrate equivalency at Site 3, A-constant with manifest refraction was compared to A-constant with autorefraction.||-0.04|-0.22|
72477242|NCT02559895|144480255|SUPERIORITY||Mean Difference (Final Values)|-1.11|STANDARD_DEVIATION|3.4||0.0001|TWO_SIDED|95.0|-1.68|-0.54|||ANCOVA|||||-0.54|-1.68|0.0001
72477243|NCT02559895|144480255|SUPERIORITY||Mean Difference (Final Values)|-0.69|STANDARD_DEVIATION|3.4||0.0182|TWO_SIDED|95.0|-1.25|-0.12|||ANCOVA|||||-0.12|-1.25|0.0182
72477244|NCT02559895|144480255|SUPERIORITY||Mean Difference (Final Values)|-0.82|STANDARD_DEVIATION|3.4||0.0046|TWO_SIDED|95.0|-1.39|-0.25|||ANCOVA|||||-0.25|-1.39|0.0046
72477245|NCT02559895|144480256|SUPERIORITY||Mean Difference (Final Values)|13.5||||0.0007|TWO_SIDED|95.0|5.8|21.2|||Cochran-Mantel-Haenszel|||||21.2|5.8|0.0007
72477246|NCT02559895|144480256|SUPERIORITY||Mean Difference (Final Values)|6.0||||0.1126|TWO_SIDED|95.0|-1.4|13.3|||Cochran-Mantel-Haenszel|||||13.3|-1.4|0.1126
72477247|NCT02559895|144480256|SUPERIORITY||Mean Difference (Final Values)|8.4||||0.0272|TWO_SIDED|95.0|1.0|15.9|||Cochran-Mantel-Haenszel|||||15.9|1.0|0.0272
72477248|NCT02559895|144480257|SUPERIORITY||Mean Difference (Final Values)|11.3||||0.0066|TWO_SIDED|95.0|3.2|19.3|||Cochran-Mantel-Haenszel|||||19.3|3.2|0.0066
72477249|NCT02559895|144480257|SUPERIORITY||Mean Difference (Final Values)|10.5||||0.0112|TWO_SIDED|95.0|2.4|18.6|||Cochran-Mantel-Haenszel|||||18.6|2.4|0.0112
72477250|NCT02559895|144480257|SUPERIORITY||Mean Difference (Final Values)|9.8||||0.017|TWO_SIDED|95.0|1.8|17.8|||Cochran-Mantel-Haenszel|||||17.8|1.8|0.0170
72477251|NCT02559895|144480258|SUPERIORITY||Mean Difference (Final Values)|18.9||||0.0001|TWO_SIDED|95.0|9.8|28.0|||Cochran-Mantel-Haenszel|||||28.0|9.8|0.0001
72477252|NCT02559895|144480258|SUPERIORITY||Mean Difference (Final Values)|12.4||||0.0085|TWO_SIDED|95.0|3.2|21.5|||Cochran-Mantel-Haenszel|||||21.5|3.2|0.0085
72477253|NCT02559895|144480258|SUPERIORITY||Mean Difference (Final Values)|12.8||||0.0064|TWO_SIDED|95.0|3.7|22.0|||Cochran-Mantel-Haenszel|||||22.0|3.7|0.0064
72477254|NCT02559895|144480259|SUPERIORITY|||||||0.0159|||||||Cochran-Mantel-Haenszel|||||||0.0159
72477255|NCT02559895|144480259|SUPERIORITY|||||||0.0312|||||||Cochran-Mantel-Haenszel|||||||0.0312
72477256|NCT02559895|144480259|SUPERIORITY|||||||0.1539|||||||Cochran-Mantel-Haenszel|||||||0.1539
72477257|NCT00452426|144480312|SUPERIORITY_OR_OTHER|||||||0.028|TWO_SIDED||||||ANOVA|||||||0.028
72477258|NCT00452426|144480314|SUPERIORITY_OR_OTHER|||||||0.007||95.0|||||ANOVA|||||||0.007
72477259|NCT00452426|144480315|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA|||||||<0.001
72477260|NCT00091169|144480321|SUPERIORITY_OR_OTHER_LEGACY|||||||0.57|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.57
72477261|NCT00091169|144480322|SUPERIORITY_OR_OTHER_LEGACY|||||||0.64|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.64
72477262|NCT00091169|144480323|SUPERIORITY_OR_OTHER_LEGACY|||||||0.93|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.93
72477263|NCT00091169|144480324|SUPERIORITY_OR_OTHER_LEGACY|||||||0.61|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.61
72477264|NCT00091169|144480325|SUPERIORITY_OR_OTHER_LEGACY|||||||1e-05|TWO_SIDED||||||Fisher Exact|||||||0.00001
72477265|NCT00091169|144480326|SUPERIORITY_OR_OTHER_LEGACY|||||||0.677|TWO_SIDED||||||Fisher Exact|||||||0.677
72477266|NCT00872989|144480327|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.99||||0.49|TWO_SIDED|80.0|0.79|1.26|||Regression, Cox|||||1.26|0.79|0.49
72477267|NCT00872989|144480329|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.25||||0.83|TWO_SIDED|80.0|0.93|1.68|||Regression, Cox|||||1.68|0.93|0.83
72477268|NCT02233543|144480379|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.44||||0.2419|TWO_SIDED|95.0|-1.21|0.32|||Mixed Models Analysis|||||0.32|-1.21|0.2419
72477269|NCT02233543|144480380|SUPERIORITY_OR_OTHER||Mean Difference (Net)|7.79||||0.2016|TWO_SIDED|95.0|-4.51|20.08|||Mixed Models Analysis|||||20.08|-4.51|0.2016
72477270|NCT03573583|144480391|SUPERIORITY||Mean Difference (Final Values)|2.29||||0.03|TWO_SIDED|95.0|0.22|4.36||No formal adjustment for type I error due to the pilot nature of the study. All significance tests were 2-tailed and an alpha level of 0.05 was required for significance.|ANCOVA|Adjusted for baseline score.||Continuous variables were expressed as mean (SD) and categorical variables were as frequencies and percentages. A 2-sided independent-sample t test was used to compare group differences in change scores. Change scores were calculated as Week 16 measurements minus baseline measurements. Statistical analyses were done by a blinded statistician without knowledge of group membership.||4.36|0.22|0.03
72477271|NCT03573583|144480392|SUPERIORITY||Mean Difference (Final Values)|1.04||||0.009|TWO_SIDED|95.0|0.31|1.77|||ANCOVA|Adjusted for baseline score.||||1.77|0.31|0.009
72477272|NCT03573583|144480393|SUPERIORITY||Mean Difference (Final Values)|1.29||||0.07|TWO_SIDED|95.0|-0.1|2.67|||ANCOVA|Baseline as covariate||||2.67|-0.10|0.07
72508682|NCT02749721|144548160|OTHER||Pearson's R|-0.397||||0.083|TWO_SIDED||||||Pearson's correlation|||Correlation between MADRS and VGNG P200 (amplitude) baseline scores||||0.083
72508683|NCT02749721|144548160|OTHER||Pearson's R|-0.476||||0.034|TWO_SIDED||||||Pearson's correlation|||Correlation between MADRS and VGNG P3a (amplitude) baseline scores||||0.034
72508684|NCT02749721|144548160|OTHER||Pearson's R|-0.509||||0.031|TWO_SIDED||||||Pearson's correlation|||Correlation between DSST and AOB P200 baseline scores||||0.031
72508685|NCT02749721|144548160|OTHER||Pearson's R|-0.197||||0.5|TWO_SIDED||||||Pearson's correlation|||Correlation between DSST and AOB P3a (amplitude) baseline scores||||0.500
72508686|NCT02749721|144548160|OTHER||Pearson's R|0.376||||0.185|TWO_SIDED||||||Pearson's correlation|||Correlation between DSST and AOB P3b baseline scores||||0.185
72508687|NCT02749721|144548160|OTHER||Pearson's R|-0.108||||0.659|TWO_SIDED||||||Pearson's correlation|||Correlation between DSST and VGNG P200 baseline scores||||0.659
72508688|NCT02749721|144548160|OTHER||Pearson's R|0.125||||0.611|TWO_SIDED||||||Pearson's correlation|||Correlation between DSST and VGNG P3a baseline scores||||0.611
72477273|NCT03573583|144480394|OTHER|Pearson's correlation coefficients, along with their 95% confidence intervals (CIs)|Pearson's Correlation coefficient|0.19||||0.49|TWO_SIDED|95.0|-0.35|0.64|||Pearson's Correlation coefficient|||||0.64|-0.35|0.49
72477274|NCT03730480|144480401|OTHER|count of number of results within 15% of reference analyzer||||||||||||||||count of number of responses|The number of results that are within 15% of reference analyzer is reported.|||
72477275|NCT02480153|144480403|NON_INFERIORITY_OR_EQUIVALENCE|Confidence interval (CIs) calculated by the score statistic method were used for the inference of the equivalence for ACR20 at Week 12. Therapeutic equivalence could be established if the 2-sided 95% CI fell within (-14%, 14%). Non-responder imputation was applied. Comparisons between treatments were computed as PF-06410293 versus Adalimumab-EU.|Week 12 ACR20 response rate difference|-2.98|||||TWO_SIDED|95.0|-10.38|4.44||||||||4.44|-10.38|
72477276|NCT02480153|144480403|NON_INFERIORITY_OR_EQUIVALENCE|Confidence interval (CIs) calculated by the score statistic method were used for the inference of the equivalence for ACR20 at Week 12. Therapeutic equivalence could be established if 2-sided 90% CI fell within (-12%, 15%). Non-responder imputation was applied. Comparisons between treatments were computed as PF-06410293 versus Adalimumab-EU.|Week 12 ACR20 response rate difference|-2.98|||||TWO_SIDED|90.0|-9.25|3.28||||||||3.28|-9.25|
72477277|NCT00495586|144480459|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence.|Mean Difference (Final Values)|14.2|STANDARD_DEVIATION|9.5|<|0.05|TWO_SIDED|95.0|3.7|24.3|||Chi-squared|||For the comparison of the efficacy of antibiotic versus placebo, we accepted a null hypothesis if the cure rate in the intervention group was the same or ±7% as that observed in the placebo arm. Based on previous studies, the expected rate of cure among patients assigned to antibiotic therapy was 90%. For an alpha of 0.05 and a beta of 0.2 and accepting possible losses of 15%, we calculated that the sample size is 677 patients in total.||24.3|3.7|<0.05
72477278|NCT00158860|144480463|SUPERIORITY||Kaplan-Meier estimates|27.3|||<|0.001|TWO_SIDED|95.0|16.0|38.6|||Log Rank|||||38.6|16.0|<0.001
72477279|NCT00158860|144480463|SUPERIORITY||Hazard Ratio (HR)|0.401|||<|0.001|TWO_SIDED|95.0|0.282|0.57|||Log Rank|||||0.570|0.282|<0.001
72477280|NCT00158860|144480464|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon rank sum test|||||||<0.001
72477281|NCT00964886|144480508|SUPERIORITY_OR_OTHER|||||||0.7|||||||ANCOVA|||In an intent-to-treat analysis of all randomized participants assigned to experimental drug (desipramine) or active placebo (benztropine) an analysis of variance compared mean Descriptor Differential Scale scores at 12 weeks (or last observation carried forward) adjusted fro mean baseline score ( = ).||||0.7
72508689|NCT02749721|144548160|OTHER||Pearson's R|-0.111||||0.671|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P200 (amplitude) and MADRS (baseline to endpoint percent change)||||0.671
72477282|NCT00964886|144480509|SUPERIORITY_OR_OTHER|||||||0.84|||||||ANCOVA|Means are adjusted for baseline Roland and Morris scores.||In the intent-to-treat sample of all randomized participants assigned to experimental drug (desipramine) or active placebo (benztropine) an analysis of variance (ANOVA) compared mean Roland and Morris scores at 12 weeks adjusted for mean baseline scores.||||0.84
72477283|NCT00964886|144480510|SUPERIORITY_OR_OTHER|||||||0.6|||||||ANCOVA|||||||0.6
72477284|NCT00964886|144480511|SUPERIORITY_OR_OTHER|||||||0.8|||||||ANCOVA|||This analysis compares outcomes for participants assigned at baseline to receive cognitive behavioral therapy or not to receive cognitive behavioral therapy (behavioral effect)||||0.8
72477285|NCT04587752|144480517|SUPERIORITY|||||||0.047|||||||t-test, 2 sided|||||||.047
72477286|NCT04587752|144480518|SUPERIORITY|||||||0.01|||||||t-test, 2 sided|||||||.01
72508690|NCT02749721|144548160|OTHER||Pearson's R|-0.026||||0.931|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P3a (amplitude) and MADRS (baseline to endpoint percent change)||||0.931
72477287|NCT04587752|144480519|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<.001
72477288|NCT00652327|144480534|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0026|||||||Wilcoxon rank sum test|||||||.0026
72477289|NCT02926898|144480543|SUPERIORITY||Percent difference|-54.0|||<|0.001|TWO_SIDED|95.0|-67.2|-35.6||Analysis of covariance (ANCOVA) model with treatment group (ZX008 or placebo) and age group (\< 6 years, ≥ 6 years) as factors, and with log baseline frequency as a covariate, and log CSF as the outcome variable.|ANCOVA|||||-35.6|-67.2|<0.001
72477290|NCT02926898|144480544|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|A logistic regression model using a categorical response variable as a function of Treatment group, Baseline seizure frequency, and age group.||||||<0.001
72477291|NCT02926898|144480545|SUPERIORITY|||||||0.004|||||||Wilcoxon (Mann-Whitney)|||||||0.004
72477292|NCT03535597|144480566|OTHER||Risk Ratio (RR)|0.99||||0.906|TWO_SIDED|95.0|0.89|1.11|||Chi-squared|||||1.11|0.89|0.906
72477293|NCT03535597|144480566|OTHER||Risk Ratio (RR)|1.27||||0.002|TWO_SIDED|95.0|1.09|1.53|||Chi-squared|||||1.53|1.09|0.002
72477294|NCT03535597|144480566|OTHER||Risk Ratio (RR)|0.97||||0.613|TWO_SIDED|95.0|0.86|1.09|||Chi-squared|||||1.09|0.86|0.613
72477295|NCT03535597|144480567|OTHER||Mean Difference (Net)|-98.5|||<|0.001|TWO_SIDED||||||t-test, 2 sided|||||||<0.001
72477296|NCT03535597|144480567|OTHER||Mean Difference (Net)|-120.6|||<|0.001|TWO_SIDED||||||t-test, 2 sided|||||||< 0.001
72477297|NCT03535597|144480567|OTHER||Mean Difference (Net)|-94.3|||<|0.001|TWO_SIDED||||||t-test, 2 sided|||||||< 0.001
72477298|NCT03535597|144480568|OTHER||Risk Ratio (RR)|0.77||||0.744|TWO_SIDED|95.0|0.23|2.57|||Fisher Exact|||||2.57|0.23|0.744
72477299|NCT03535597|144480568|OTHER||Risk Ratio (RR)|1.02|||>|0.999|TWO_SIDED|95.0|0.31|3.41|||Fisher Exact|||||3.41|0.31|>0.999
72477300|NCT03535597|144480568|OTHER||Risk Ratio (RR)|0.67||||0.724|TWO_SIDED|95.0|0.18|2.46|||Fisher Exact|||||2.46|0.18|0.724
72477301|NCT03535597|144480569|OTHER||Risk Ratio (RR)|1.44||||0.594|TWO_SIDED|95.0|0.56|3.76|||Fisher Exact|||||3.76|0.56|0.594
72477302|NCT03535597|144480569|OTHER||Risk Ratio (RR)|1.1|||>|0.999|TWO_SIDED|95.0|0.37|3.26|||Fisher Exact|||||3.26|0.37|>0.999
72477303|NCT03535597|144480569|OTHER||Risk Ratio (RR)|1.45||||0.581|TWO_SIDED|95.0|0.55|3.88|||Fisher Exact|||||3.88|0.55|0.581
72508691|NCT02749721|144548160|OTHER||Pearson's R|0.516||||0.155|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P3b (amplitude) and MADRS (baseline to endpoint percent change)||||0.155
72508692|NCT02749721|144548160|OTHER||Pearson's R|0.268||||0.297|TWO_SIDED||||||Pearson's correlation|||Correlation between VGNG P200 (amplitude) and MADRS (baseline to endpoint percent change)||||0.297
72508693|NCT02749721|144548160|OTHER||Pearson's R|0.184||||0.494|TWO_SIDED||||||Pearson's correlation|||Correlation between VGNG P3a (amplitude) and MADRS (baseline to endpoint percent change)||||0.494
72508694|NCT02749721|144548160|OTHER||Pearson's R|-0.065||||0.811|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P200 (amplitude) and DSST (baseline to endpoint percent change)||||0.811
72477304|NCT03535597|144480570|OTHER||Risk Ratio (RR)|1.92||||0.284|TWO_SIDED|95.0|0.71|5.22|||Fisher Exact|||||5.22|0.71|0.284
72477305|NCT03535597|144480570|OTHER||Risk Ratio (RR)|2.1||||0.243|TWO_SIDED|95.0|0.75|5.9|||Fisher Exact|||||5.9|0.75|0.243
72477306|NCT03535597|144480570|OTHER||Risk Ratio (RR)|2.01||||0.266|TWO_SIDED|95.0|0.74|5.54|||Fisher Exact|||||5.54|0.74|0.266
72477307|NCT00141219|144480583|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|1.115||||0.289||95.0|0.785|1.583||All statistical testing was 2-sided and was conducted at the 5% level of significance.|Cochran-Mantel-Haenszel|P-value in above table was from Cochran-Mantel-Haenszel test comparing Pregabalin and Placebo adjusted for center.|RR estimates relative responder rate between Pregabalin and Placebo (the ratio of the former responder rate to the latter). Estimated RR was center-adjusted ie, assumed common RR in all centers, then a weighted average of center specific RRs computed|Null hypothesis of no treatment difference in each of the centers.||1.583|0.785|0.289
72477308|NCT00141219|144480584|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|1.644||||0.041||95.0|0.915|2.954||All statistical testing was 2-sided and was conducted at the 5% level of significance.|Cochran-Mantel-Haenszel|P-value in above table was from Cochran-Mantel-Haenszel test comparing Pregabalin and Placebo adjusted for center.|RR estimates relative responder rate between Pregabalin and Placebo (the ratio of the former responder rate to the latter). Estimated RR was center-adjusted ie, assumed common RR in all centers, then a weighted average of center specific RRs computed|Null hypothesis of no treatment difference in each of the centers.||2.954|0.915|0.041
72477309|NCT00141219|144480585|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|0.252||0.049||95.0|-1.0|0.0||All statistical testing was 2-sided and was conducted at the 5% level of significance.|General Linear Model|Estimated from the general linear model with treatment and center fitted as factors and the baseline value as a covariate.||Null hypotheses stated there was no difference in pregabalin and placebo in the primary endpoint versus the alternative that there was. The target sample size was 234 subjects (156 and 78 respectively pregabalin vs placebo using a 2:1 ratio). The calculations assumed a 2-sided comparison at 0.05 alpha, 80% power and 3% dropout. Also, a treatment difference of 1 point and a standard deviation for endpoint mean pain scores of 2.5 were assumed based on previous studies.||-0.00|-1.00|0.049
72477310|NCT00141219|144480585|SUPERIORITY_OR_OTHER_LEGACY|||||||0.729||95.0||||Interaction p-value based on adding interaction term to the main model.|General Linear Model|"In supportive model 1, a treatment by center independent variable added to the main model."||This was a supportive analysis of the primary endpoint to determine if the main results were generalizable across centers.||||0.729
72477311|NCT00141219|144480585|SUPERIORITY_OR_OTHER_LEGACY|||||||0.979||95.0||||Interaction p-value based on adding interaction term to the main model.|General Linear Model|"In supportive model 2, a treatment by baseline mean pain independent variable added to the main model."||This was a supportive analysis of the primary endpoint to determine if the main results were generalizable across different baseline values.||||0.979
72477312|NCT00141219|144480586|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.48|STANDARD_ERROR_OF_MEAN|0.267||0.077||95.0|-1.0|0.05||All statistical testing was 2-sided and was conducted at the 5% level of significance.|General Linear Model|Estimated from general linear model with treatment and center fitted as factors and the baseline value as a covariate.||"Endpoint Mean Pain Score~Pregabalin minus Placebo"||0.05|-1.00|0.077
72477313|NCT00141219|144480587|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.38|STANDARD_ERROR_OF_MEAN|0.186||0.042||95.0|-0.75|-0.01||All statistical testing was 2-sided and was conducted at the 5% level of significance.|Linear Mixed Model|Estimated from a linear mixed model with treatment, week, center, and treatment by week interaction as factors and baseline value as a covariate.||"Mean Pain Score Weeks 1 to 8~Overall Comparison (8-week average)~Pregabalin minus Placebo"||-0.01|-0.75|0.042
72477314|NCT00141219|144480587|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.38|STANDARD_ERROR_OF_MEAN|0.21||0.071||95.0|-0.79|0.03||All statistical testing was 2-sided and was conducted at the 5% level of significance.|Linear Mixed Model|Estimated from a linear mixed model with treatment, week, center and treatment by week interaction as factors and baseline value as a covariate.||"Week 1 Mean Pain Score~Pregabalin minus Placebo"||0.03|-0.79|0.071
72477315|NCT00141219|144480587|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.31|STANDARD_ERROR_OF_MEAN|0.212||0.149||95.0|-0.72|0.11||All statistical testing was 2-sided and was conducted at the 5% level of significance.|Linear Mixed Model|Estimated from a linear mixed model with treatment, week, center and treatment by week interaction as factors and baseline value as a covariate.||"Week 2 Mean Pain Score~Pregabalin minus Placebo"||0.11|-0.72|0.149
72477316|NCT00141219|144480587|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.41|STANDARD_ERROR_OF_MEAN|0.213||0.057||95.0|-0.82|0.01||All statistical testing was 2-sided and was conducted at the 5% level of significance.|Linear Mixed Model|Estimated from a linear mixed model with treatment, week, center and treatment by week interaction as factors and baseline value as a covariate.||"Week 3 Mean Pain Score~Pregabalin minus Placebo"||0.01|-0.82|0.057
72477317|NCT00141219|144480587|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.43|STANDARD_ERROR_OF_MEAN|0.215||0.044||95.0|-0.85|-0.01||All statistical testing was 2-sided and was conducted at the 5% level of significance.|Linear Mixed Model|Estimated from a linear mixed model with treatment, week, center and treatment by week interaction as factors and baseline value as a covariate.||"Week 4 Mean Pain Score~Pregabalin minus Placebo"||-0.01|-0.85|0.044
72508695|NCT02749721|144548160|OTHER||Pearson's R|-0.048||||0.877|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P3a (amplitude) and DSST (baseline to endpoint percent change)||||0.877
72508696|NCT02749721|144548160|OTHER||Pearson's R|-0.246||||0.557|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P3b (amplitude) and DSST (baseline to endpoint percent change)||||0.557
72477318|NCT00141219|144480587|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.42|STANDARD_ERROR_OF_MEAN|0.216||0.051||95.0|-0.85|0.0||All statistical testing was 2-sided and was conducted at the 5% level of significance.|Linear Mixed Model|Estimated from a linear mixed model with treatment, week, center and treatment by week interaction as factors and baseline value as a covariate.||"Week 5 Mean Pain Score~Pregabalin minus Placebo"||0.00|-0.85|0.051
72477319|NCT00141219|144480587|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.29|STANDARD_ERROR_OF_MEAN|0.216||0.178||95.0|-0.72|0.13||All statistical testing was 2-sided and was conducted at the 5% level of significance.|Linear Mixed Model|Estimated from a linear mixed model with treatment, week, center and treatment by week interaction as factors and baseline value as a covariate.||"Week 6 Mean Pain Score~Pregabalin minus Placebo"||0.13|-0.72|0.178
72477320|NCT00141219|144480587|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.35|STANDARD_ERROR_OF_MEAN|0.218||0.104||95.0|-0.78|0.07||All statistical testing was 2-sided and was conducted at the 5% level of significance.|Linear Mixed Model|Estimated from a linear mixed model with treatment, week, center and treatment by week interaction as factors and baseline value as a covariate.||"Week 7 Mean Pain Score~Pregabalin minus Placebo"||0.07|-0.78|0.104
72477321|NCT00141219|144480587|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.45|STANDARD_ERROR_OF_MEAN|0.218||0.039||95.0|-0.88|-0.02||All statistical testing was 2-sided and was conducted at the 5% level of significance.|Linear Mixed Model|Estimated from a linear mixed model with treatment, week, center and treatment by week interaction as factors and baseline value as a covariate.||"Week 8 Mean Pain Score~Pregabalin minus Placebo"||-0.02|-0.88|0.039
72477322|NCT00141219|144480588|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.38|STANDARD_ERROR_OF_MEAN|0.186||0.044||95.0|-0.74|-0.01||All statistical testing was 2-sided and was conducted at the 5% level of significance.|General Linear Model|Estimated from general linear model with treatment and center as factors and baseline value as a covariate.||"Duration Adjusted Average Change (DAAC)~Pregabalin minus Placebo"||-0.01|-0.74|0.044
72477323|NCT00141219|144480589|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.65|STANDARD_ERROR_OF_MEAN|0.272||0.018||95.0|-1.19|-0.11||All statistical testing was 2-sided and was conducted at the 5% level of significance.|General Linear Model|Estimated from general linear model with treatment and center as factors and baseline value as a covariate.||"Endpoint Sleep Interference Score~Pregabalin minus Placebo"||-0.11|-1.19|0.018
72477324|NCT00141219|144480590|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.51|STANDARD_ERROR_OF_MEAN|0.226||0.024||95.0|-0.96|-0.07||All statistical testing was 2-sided and was conducted at the 5% level of significance.|Linear Mixed Model|Estimated from a linear mixed model with treatment, week, center and treatment by week interaction as factors and baseline value as a covariate.||"Weeks 1 to 8 Mean Sleep Score~Overall Comparison (8-week average)~Pregabalin minus Placebo"||-0.07|-0.96|0.024
72477325|NCT00141219|144480590|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.38|STANDARD_ERROR_OF_MEAN|0.245||0.12||95.0|-0.86|0.1||All statistical testing was 2-sided and was conducted at the 5% level of significance.|Linear Mixed Model|Estimated from a linear mixed model with treatment, week, center and treatment by week interaction as factors and baseline value as a covariate.||"Week 1 Sleep Interference Score~Pregabalin minus Placebo"||0.10|-0.86|0.120
72508697|NCT02749721|144548160|OTHER||Pearson's R|0.182||||0.5|TWO_SIDED||||||Pearson's correlation|||Correlation between VGNG P200 (amplitude) and DSST (baseline to endpoint percent change)||||0.500
72508698|NCT02749721|144548160|OTHER||Pearson's R|0.288||||0.297|TWO_SIDED||||||Pearson's correlation|||Correlation between VGNG P3a (amplitude) and DSST (baseline to endpoint percent change)||||0.297
72508699|NCT02749721|144548160|OTHER|Differences in BNA scores between MDD and healthy subjects were analyzed for baseline visits using an ANCOVA model with group as a factor, and age as a covariate.|F statistic|0.318||||0.575|TWO_SIDED||||||ANCOVA|||"A comparison between vortioxetine arm patients' and healthy controls' AOB P200 amplitudes at baseline.~The healthy control group subjects have been previously documented in NCT02418208 (Clinical trials of the Rockies, Inc. Denver, Colorado, US and Clinical Research Center of Nevada Las Vegas, Nevada, US ) and in NCT02875496 (The Villages Health, The Villages, Florida, US)."||||0.575
72508700|NCT02749721|144548160|OTHER||F statistic|0.378||||0.541|TWO_SIDED||||||ANCOVA|||"A comparison between vortioxetine arm patients' and healthy controls' AOB P200 amplitudes at Endpoint.~The healthy control group subjects have been previously documented in NCT02418208 (Clinical trials of the Rockies, Inc. Denver, Colorado, US and Clinical Research Center of Nevada Las Vegas, Nevada, US ) and in NCT02875496 (The Villages Health, The Villages, Florida, US)."||||0.541
72508701|NCT02749721|144548160|OTHER||F|0.012||||0.912|TWO_SIDED||||||ANCOVA|||"A comparison between vortioxetine arm patients' and healthy controls' AOB P3a amplitudes at baseline.~The healthy control group subjects have been previously documented in NCT02418208 (Clinical trials of the Rockies, Inc. Denver, Colorado, US and Clinical Research Center of Nevada Las Vegas, Nevada, US ) and in NCT02875496 (The Villages Health, The Villages, Florida, US)."||||0.912
72508702|NCT02749721|144548160|OTHER||F statistic|1.586||||0.214|TWO_SIDED||||||ANCOVA|||"A comparison between vortioxetine arm patients' and healthy controls' AOB P3a amplitudes at Endpoint.~The healthy control group subjects have been previously documented in NCT02418208 (Clinical trials of the Rockies, Inc. Denver, Colorado, US and Clinical Research Center of Nevada Las Vegas, Nevada, US ) and in NCT02875496 (The Villages Health, The Villages, Florida, US)."||||0.214
72477326|NCT00141219|144480590|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.51|STANDARD_ERROR_OF_MEAN|0.246||0.041||95.0|-0.99|-0.02||All statistical testing was 2-sided and was conducted at the 5% level of significance.|Linear Mixed Model|Estimated from a linear mixed model with treatment, week, center and treatment by week interaction as factors and baseline value as a covariate.||"Week 2 Sleep Interference Score~Pregabalin minus Placebo"||-0.02|-0.99|0.041
72477327|NCT00141219|144480590|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.59|STANDARD_ERROR_OF_MEAN|0.248||0.017||95.0|-1.07|-0.1||All statistical testing was 2-sided and was conducted at the 5% level of significance.|Linear Mixed Model|Estimated from a linear mixed model with treatment, week, center and treatment by week interaction as factors and baseline value as a covariate.||"Week 3 Sleep Interference Score~Pregabalin minus Placebo"||-0.10|-1.07|0.017
72566395|NCT02697773|144663267|SUPERIORITY||Odds Ratio (OR)|2.29|||<|0.0001|TWO_SIDED|95.0|1.52|3.46|||Regression, Logistic|||Week 12, \>=70%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.46|1.52|<.0001
72399690|NCT03997383|144306775|SUPERIORITY||Median Difference (Net)|14.693||||0.0162|TWO_SIDED|95.0|0.693|28.692||P-value was determined by the Wilcoxon Rank Sum test,stratified by baseline tafamidis use.Analysis was performed on the 100 multiply-imputed datasets.|Wilcoxon Rank Sum Test||Median difference estimated by the Hodges-Lehmann method, stratified by baseline tafamidis use. Analysis was performed on the 100 multiply-imputed datasets.|||28.692|0.693|0.0162
72477328|NCT00141219|144480590|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.53|STANDARD_ERROR_OF_MEAN|0.249||0.033||95.0|-1.02|-0.04||All statistical testing was 2-sided and was conducted at the 5% level of significance.|Linear Mixed Model|Estimated from a linear mixed model with treatment, week, center and treatment by week interaction as factors and baseline value as a covariate.||"Week 4 Sleep Interference Score~Pregabalin minus Placebo"||-0.04|-1.02|0.033
72508703|NCT02749721|144548160|OTHER||F statistic|0.453||||0.504|TWO_SIDED||||||ANCOVA|||"A comparison between vortioxetine arm patients' and healthy controls' AOB P3b amplitudes at baseline.~The healthy control group subjects have been previously documented in NCT02418208 (Clinical trials of the Rockies, Inc. Denver, Colorado, US and Clinical Research Center of Nevada Las Vegas, Nevada, US ) and in NCT02875496 (The Villages Health, The Villages, Florida, US)."||||0.504
72399691|NCT03997383|144306776|SUPERIORITY||Least squares (LS) mean difference|3.709|STANDARD_ERROR_OF_MEAN|1.796||0.0397|TWO_SIDED|95.0|0.176|7.242||P-value was analyzed using mixed model repeated measures (MMRM) as described in the Statistical analysis plan.|MMRM|||||7.242|0.176|0.0397
72477329|NCT00141219|144480590|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.44|STANDARD_ERROR_OF_MEAN|0.25||0.078||95.0|-0.93|0.05||All statistical testing was 2-sided and was conducted at the 5% level of significance.|Linear Mixed Model|Estimated from a linear mixed model with treatment, week, center and treatment by week interaction as factors and baseline value as a covariate.||"Week 5 Sleep Interference Score~Pregabalin minus Placebo"||0.05|-0.93|0.078
72477330|NCT00141219|144480590|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.52|STANDARD_ERROR_OF_MEAN|0.25||0.038||95.0|-1.01|-0.03||All statistical testing was 2-sided and was conducted at the 5% level of significance.|Linear Mixed Model|Estimated from a linear mixed model with treatment, week, center and treatment by week interaction as factors and baseline value as a covariate.||"Week 6 Sleep Interference Score~Pregabalin minus Placebo"||-0.03|-1.01|0.038
72477331|NCT00141219|144480590|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.53|STANDARD_ERROR_OF_MEAN|0.252||0.037||95.0|-1.02|-0.03||All statistical testing was 2-sided and was conducted at the 5% level of significance.|Linear Mixed Model|Estimated from a linear mixed model with treatment, week, center and treatment by week interaction as factors and baseline value as a covariate.||"Week 7 Sleep Interference Score~Pregabalin minus Placebo"||-0.03|-1.02|0.037
72477332|NCT00141219|144480590|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.61|STANDARD_ERROR_OF_MEAN|0.252||0.015||95.0|-1.11|-0.12||All statistical testing was 2-sided and was conducted at the 5% level of significance.|Linear Mixed Model|Estimated from a linear mixed model with treatment, week, center and treatment by week interaction as factors and baseline value as a covariate.||"Week 8 Sleep Interference Score~Pregabalin minus Placebo"||-0.12|-1.11|0.015
72508704|NCT02749721|144548160|OTHER||F statistic|0.37||||0.546|TWO_SIDED||||||ANCOVA|||"A comparison between vortioxetine arm patients' and healthy controls' AOB P3b amplitudes at Endpoint.~The healthy control group subjects have been previously documented in NCT02418208 (Clinical trials of the Rockies, Inc. Denver, Colorado, US and Clinical Research Center of Nevada Las Vegas, Nevada, US ) and in NCT02875496 (The Villages Health, The Villages, Florida, US)."||||0.546
72477333|NCT00141219|144480591|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.62|STANDARD_ERROR_OF_MEAN|2.639||0.034||95.0|-10.82|-0.42||All statistical testing was 2-sided and was conducted at the 5% level of significance.|General Linear Model|Estimated from general linear model with treatment and center as factors and baseline value as a covariate.||"Week 8 Sleep Disturbance~Pregabalin minus Placebo"||-0.42|-10.82|0.034
72477334|NCT00141219|144480592|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.05|STANDARD_ERROR_OF_MEAN|3.309||0.128||95.0|-1.47|11.58||All statistical testing was 2-sided and was conducted at the 5% level of significance.|General Linear Model|Estimated from general linear model with treatment and center as factors and baseline value as a covariate.||"Week 8 Snoring Score~Pregabalin minus Placebo"||11.58|-1.47|0.128
72477335|NCT00141219|144480593|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.09|STANDARD_ERROR_OF_MEAN|1.887||0.103||95.0|-6.81|0.63||All statistical testing was 2-sided and was conducted at the 5% level of significance.|General Linear Model|Estimated from general linear model with treatment and center as factors and baseline value as a covariate.||"Week 8 Awaken Short of Breath or Headache~Pregabalin minus Placebo"||0.63|-6.81|0.103
72508705|NCT02749721|144548160|OTHER||F statistic|0.017||||0.895|TWO_SIDED||||||ANCOVA|||"A comparison between vortioxetine arm patients' and healthy controls' VGNG P200 amplitudes at baseline.~The healthy control group subjects have been previously documented in NCT02418208 (Clinical trials of the Rockies, Inc. Denver, Colorado, US and Clinical Research Center of Nevada Las Vegas, Nevada, US ) and in NCT02875496 (The Villages Health, The Villages, Florida, US)."||||0.895
72508706|NCT02749721|144548160|OTHER||F statistic|0.179||||0.673|TWO_SIDED||||||ANCOVA|||"A comparison between vortioxetine arm patients' and healthy controls' VGNG P200 amplitudes at Endpoint.~The healthy control group subjects have been previously documented in NCT02418208 (Clinical trials of the Rockies, Inc. Denver, Colorado, US and Clinical Research Center of Nevada Las Vegas, Nevada, US ) and in NCT02875496 (The Villages Health, The Villages, Florida, US)."||||0.673
72508707|NCT02749721|144548160|OTHER||F statistic|1.241||||0.27|TWO_SIDED||||||ANCOVA|||"A comparison between vortioxetine arm patients' and healthy controls' VGNG P3a amplitudes at baseline.~The healthy control group subjects have been previously documented in NCT02418208 (Clinical trials of the Rockies, Inc. Denver, Colorado, US and Clinical Research Center of Nevada Las Vegas, Nevada, US ) and in NCT02875496 (The Villages Health, The Villages, Florida, US)."||||0.27
72399692|NCT03997383|144306777|SUPERIORITY||Stratified Win Ratio|1.27||||0.0574|TWO_SIDED|95.0|0.99|1.61|||Z-test|P-value was analyzed by a z-test using the mean and variance of the log-transformed win ratio estimate.||||1.61|0.99|0.0574
72477336|NCT00141219|144480594|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.44|STANDARD_ERROR_OF_MEAN|0.182||0.018||95.0|0.08|0.8||All statistical testing was 2-sided and was conducted at the 5% level of significance.|General Linear Model|Estimated from general linear model with treatment and center as factors and baseline value as a covariate.||"Week 8 Sleep Quantity~Pregabalin minus Placebo"||0.80|0.08|0.018
72477337|NCT00141219|144480595|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.23|STANDARD_ERROR_OF_MEAN|0.37||0.504||95.0|0.67|2.24||All statistical testing was 2-sided and was conducted at the 5% level of significance.|Regression, Logistic|OR estimated from model with Optimal sleep status (Yes/No) as response variable, and treatment, baseline Optimal sleep status as explanatory variables|"The OR estimates ratio of Odds of optimal sleep between Pregabalin and Placebo (ie, the former to the latter). Odds of optimal sleep in treatment group is ratio of Probability of having optimal sleep vs Probability of Not having optimal sleep"|"Week 8 Optimal Sleep~Optimal Sleep is a binary outcome derived from Sleep Quantity (SQ): the response is YES (or 1) if SQ = 7 or 8 hours per night.~Odds ratio measured the odds of optimal sleep in pregabalin to that in placebo.~Standard Error of the Mean equals Standard Error of the Odds Ratio (OR)."||2.24|0.67|.504
72477338|NCT00141219|144480596|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.15|STANDARD_ERROR_OF_MEAN|3.796||0.571||95.0|-5.33|9.63||All statistical testing was 2-sided and was conducted at the 5% level of significance.|General Linear model|Estimated from general linear model with treatment and center as factors and baseline value as a covariate.||"Week 8 Sleep Adequacy~Pregabalin minus Placebo"||9.63|-5.33|0.571
72477339|NCT00141219|144480597|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.71|STANDARD_ERROR_OF_MEAN|2.349||0.046||95.0|0.08|9.34||All statistical testing was 2-sided and was conducted at the 5% level of significance.|General Linear Model|Estimated from general linear model with treatment and center as factors and baseline value as a covariate.||"Week 8 Somnolence~Pregabalin minus Placebo"||9.34|0.08|0.046
72477340|NCT00141219|144480598|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.12|STANDARD_ERROR_OF_MEAN|2.044||0.3||95.0|-6.15|1.91||All statistical testing was 2-sided and was conducted at the 5% level of significance.|General Linear Model|Estimated from general linear model with treatment and center as factors and baseline value as a covariate.||"Week 8 Overall Sleep Problem~Pregabalin minus Placebo"||1.91|-6.15|0.300
72477341|NCT00141219|144480599|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.026|STANDARD_ERROR_OF_MEAN|0.0325||0.429||95.0|-0.038|0.09||All statistical testing was 2-sided and was conducted at the 5% level of significance.|General Linear Model|Estimated from general linear model with treatment and center as factors and baseline value as a covariate.||"Endpoint Utility Score~Pregabalin minus Placebo"||0.090|-0.038|0.429
72477342|NCT00141219|144480600|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.5|STANDARD_ERROR_OF_MEAN|2.375||0.142||95.0|-1.18|8.18||All statistical testing was 2-sided and was conducted at the 5% level of significance.|General Linear Model|Estimated from general linear model with treatment and center as factors and baseline value as a covariate.||"Endpoint VAS Score~Pregabalin minus Placebo"||8.18|-1.18|0.142
72477343|NCT00141219|144480601|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.85|STANDARD_ERROR_OF_MEAN|0.409||0.038||95.0|-1.66|-0.05||All statistical testing was 2-sided and was conducted at the 5% level of significance.|General Linear Model|Estimated from general linear model with treatment and center as factors and baseline value as a covariate.||"Endpoint Anxiety Score~Pregabalin minus Placebo"||-0.05|-1.66|0.038
72508708|NCT02749721|144548160|OTHER||F statistic|0.042||||0.837|TWO_SIDED||||||ANCOVA|||"A comparison between vortioxetine arm patients' and healthy controls' VGNG P3a amplitudes at Endpoint.~The healthy control group subjects have been previously documented in NCT02418208 (Clinical trials of the Rockies, Inc. Denver, Colorado, US and Clinical Research Center of Nevada Las Vegas, Nevada, US ) and in NCT02875496 (The Villages Health, The Villages, Florida, US)."||||0.837
72508709|NCT02749721|144548161|OTHER||Pearson's R|0.359||||0.143|TWO_SIDED||||||Pearson's correlation|||Correlation between DSST and AOB P200 (Latency) baseline scores||||0.143
72508710|NCT02749721|144548161|OTHER||Pearson's R|-0.197||||0.5|TWO_SIDED||||||Pearson's correlation|||Correlation between DSST and AOB P3b (latency) baseline scores||||0.500
72477344|NCT00141219|144480602|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.19|STANDARD_ERROR_OF_MEAN|0.438||0.664||95.0|-1.05|0.67||All statistical testing was 2-sided and was conducted at the 5% level of significance.|General Linear Model|Estimated from general linear model with treatment and center as factors and baseline value as a covariate.||"Endpoint Depression Score~Pregabalin minus Placebo"||0.67|-1.05|0.664
72477345|NCT00141219|144480603|SUPERIORITY_OR_OTHER_LEGACY|||||||0.473||95.0||||All statistical testing was 2-sided and was conducted at the 5% level of significance. p-value is from comparing Pregabalin versus Placebo.|Cochran-Mantel-Haenszel|"To apply CMH, each category is given a numerical score; the method of modified rdit used to assign numeric scores."||Cochran-Mantel-Haenszel (CMH) test on the null hypothesis of no treatment difference in all centers. CMH test comparing Pregabalin to Placebo adjusted for center.||||0.473
72477346|NCT00141219|144480604|SUPERIORITY_OR_OTHER_LEGACY|||||||0.119||95.0||||All statistical testing was 2-sided and was conducted at the 5% level of significance.|Cochran-Mantel-Haenszel|"To apply CMH, each category is given a numerical score; the method of modified rdit used to assign numeric scores."||Cochran-Mantel-Haenszel (CMH) test on the null hypothesis of no treatment difference in all centers. CMH test comparing Pregabalin to Placebo adjusted for center.||||0.119
72477347|NCT02224690|144480606|SUPERIORITY||Median Difference (Final Values)|-17.21||||0.0135|TWO_SIDED|95.0|-30.32|-4.09|||Wilcoxon rank-sum test||Calculated using the Hodges-Lehmann approach|||-4.09|-30.32|0.0135
72477348|NCT02224690|144480607|SUPERIORITY||Odds Ratio (OR)|2.57||||0.0043|TWO_SIDED|95.0|1.33|4.97|||Cochran-Mantel-Haenszel|Calculated using a Cochran-Mantel-Haenszel test stratified by age group (2-5, 6-11, 12-17 and 18-55 years)||||4.97|1.33|0.0043
72508711|NCT02749721|144548161|OTHER||Pearson's R|0.277||||0.337|TWO_SIDED||||||Pearson's correlation|||Correlation between DSST and AOB P3b (latency) baseline scores||||0.337
72508712|NCT02749721|144548161|OTHER||Pearson's R|0.052||||0.832|TWO_SIDED||||||Pearson's correlation|||Correlation between DSST and VGNG P200 (latency) baseline scores||||0.832
72508713|NCT02749721|144548161|OTHER||Pearson's R|0.103||||0.68|TWO_SIDED||||||Pearson's correlation|||Correlation between DSST and VGNG P3a (latency) baseline scores||||0.68
72508714|NCT02749721|144548161|OTHER||Pearson's R|-0.074||||0.777|TWO_SIDED||||||Pearson's correlation|||Correlation between DSST and AOB P200 (Latency) baseline to endpoint percentage change||||0.777
72477349|NCT02224690|144480608|SUPERIORITY||Mean Difference (Final Values)|-21.13||||0.0005|TWO_SIDED|95.0|-33.26|-9.37|||Wilcoxon rank-sum test||Calculated using the Hodges-Lehmann approach|||-9.37|-33.26|0.0005
72508715|NCT02749721|144548161|OTHER||Pearson's R|0.061||||0.834|TWO_SIDED||||||Pearson's correlation|||Correlation between DSST and AOB P3a (Latency) baseline to endpoint percentage change||||0.834
72399693|NCT03997383|144306778|SUPERIORITY||Hazard Ratio (HR)|0.997||||0.9888|TWO_SIDED|95.0|0.62|1.602|||Andersen-Gill||HR was derived using an Andersen-Gill model, including the treatment arm, type of ATTR amyloidosis, baseline New York Heart Association (NYHA) class, and age as covariates.|||1.602|0.620|0.9888
72477350|NCT02224690|144480609|SUPERIORITY||Odds Ratio (OR)|2.54||||0.0012|TWO_SIDED|95.0|1.45|4.47|||Regression, Logistic|Ordinal logistic regression model with treatment group as a fixed factor.|Odds of participants recording a lower score (improvement) on a continuous scale|||4.47|1.45|0.0012
72477351|NCT00122460|144480612|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.797||||0.036|TWO_SIDED|95.0|0.644|0.986|||Stratified Log Rank|||"The primary analysis tested the equality of OS between treatment groups applying a 2-sided stratified log-rank test (α=5%), taking into account the strata used for randomization (previous chemotherapy (CTX) \[no vs. yes\] and Karnofsky Performance Status (KPS) \[\<80 vs. ≥80\]).~Median overall survival was estimated using the Kaplan-Meier method. The Hazard Ratio (HR) of cetuximab + CTX over CTX alone was calculated using the Cox proportional hazards model stratified by randomization strata."||0.986|0.644|0.036
72477352|NCT00122460|144480613|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.538|||<|0.0001|TWO_SIDED|95.0|0.431|0.672|||Stratified Log Rank|||"To test the equality of PFS between treatment groups, a two-sided stratified log-rank test (α=5%)was used, taking into account strata used for randomization (previous CTX \[yes/no\] and KPS \[\<80 vs. ≥80\]).~Median PFS time was estimated using the Kaplan-Meier method. The HR of cetuximab + CTX over CTX alone was calculated using the Cox proportional hazards model stratified by randomization strata."||0.672|0.431|<0.0001
72477353|NCT00122460|144480614|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.326||||0.0001|TWO_SIDED|95.0|1.504|3.6|||Cochran-Mantel-Haenszel|||A Cochran-Mantel-Haenszel (CMH) test was performed using the randomization strata previous CTX (no vs. yes) and KPS (\<80 vs. ≥80). Treatment group comparisons were performed two-sided with α=5%.||3.600|1.504|0.0001
72477354|NCT00122460|144480615|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.881|||<|0.0001|TWO_SIDED|95.0|1.87|4.441|||Cochran-Mantel-Haenszel|||A Cochran-Mantel-Haenszel (CMH) test was performed using the randomization strata previous CTX (no vs. yes) and KPS (\<80 vs. ≥80). Treatment group comparisons were performed two-sided with α=5%.||4.441|1.870|<0.0001
72477355|NCT00122460|144480616|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.593|||<|0.0001|TWO_SIDED|95.0|0.484|0.727|||Stratified Log Rank|||"Treatment groups were compared applying a two-sided stratified log-rank test (α=5%), taking into account strata used for randomization (previous CTX \[yes/no\] and KPS \[\<80 vs. ≥80\]).~Median time to treatment failure was estimated using the Kaplan-Meier method. The HR of cetuximab + CTX over CTX alone was calculated using the Cox proportional hazards model stratified by randomization strata."||0.727|0.484|<0.0001
72477356|NCT00122460|144480617|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.762||||0.21|TWO_SIDED|95.0|0.497|1.168|||Stratified Log Rank|||"To test the equality of duration of response between treatment groups, the two-sided stratified log-rank test (α=5%) was used taking strata used for randomization into account (previous CTX \[no vs. yes\] and KPS \[\<80 vs. ≥80\]).~Median duration of response was estimated using the Kaplan-Meier method. The HR of cetuximab + CTX over CTX alone was calculated using the Cox proportional hazards model stratified by randomization strata."||1.168|0.497|0.21
72477357|NCT02595073|144480621|SUPERIORITY|||||||0.3353|||||||z-test, 2-tailed|||||||0.3353
72477358|NCT02595073|144480622|SUPERIORITY|||||||0.619|||||||ANCOVA|||||||0.6190
72477359|NCT05326815|144480684|OTHER|Spearman Correlation.|||||<|0.001|||||||t-test, 1 sided|||||||<0.001
72477360|NCT02545933|144480688|SUPERIORITY||least square mean difference|27.0||||0.011|TWO_SIDED|95.0|19.0|34.0|||ANOVA||DAPT group vs DAPT plus vorapaxar group|We hypothesized that adjunctive vorapaxar would result in a significant reduction of CAT-induced platelet aggregation. Assuming a 10% absolute reduction in CAT-induced maximal platelet aggregation with a common standard deviation of 13%, 37 patients per group with valid primary endpoint data were required to detect a significant difference with a 90% power and 2-sided alpha=0.05.||34|19|0.011
72477361|NCT00935818|144480691|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.49||||0.03|TWO_SIDED|95.0|1.05|2.12|||Regression, Logistic|||Logistic regression with covariate included for study site.||2.12|1.05|0.03
72477362|NCT00935818|144480692|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.52||||0.03|TWO_SIDED|95.0|1.04|2.22|||Regression, Logistic|||Logistic Regression - adjusting for study site||2.22|1.04|0.03
72477363|NCT00935818|144480693|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||||||< 0.001
72508716|NCT02749721|144548161|OTHER||Pearson's R|-0.006||||0.988|TWO_SIDED||||||Pearson's correlation|||Correlation between DSST and AOB P3b (Latency) baseline to endpoint percentage change||||0.988
72477364|NCT00935818|144480694|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.36||||0.09|TWO_SIDED|95.0|0.95|1.93|||Regression, Logistic|||Logistic regression adjusted for study site||1.93|0.95|0.09
72477365|NCT00935818|144480695|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.32||||0.14|TWO_SIDED|95.0|0.91|1.91|||Regression, Logistic|||Logistic Regression adjusting for study site||1.91|0.91|0.14
72477366|NCT00935818|144480696|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.39||||0.11|TWO_SIDED|95.0|0.93|2.07|||Regression, Logistic|||Logistic Regression - adjusting for study site||2.07|0.93|0.11
72477367|NCT00935818|144480697|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.4||||0.08|TWO_SIDED|95.0|0.96|2.05|||Regression, Logistic|||Logistic Regression - adjusting for site||2.05|0.96|0.08
72477368|NCT01846494|144480710|OTHER|||||||0.6173|||||||Log Rank|||||||0.6173
72477369|NCT05180500|144480711|OTHER|||||||0.7|||||||Fisher Exact|||||||.70
72477370|NCT05180500|144480712|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Concentrations that were below the lower limit of quantification (\<15 ng/mL) were set to 7.5 ng/mL for analyses.||||<.001
72477371|NCT05180500|144480715|OTHER|||||||0.28|||||||Fisher Exact|||||||0.28
72477372|NCT05180500|144480716|OTHER|||||||0.6|||||||t-test, 2 sided|||||||0.60
72477373|NCT05180500|144480717|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Concentrations that were below the lower limit of quantification (\<15 ng/mL) were set to 7.5 ng/mL for analyses.||||<.001
72477374|NCT05180500|144480718|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Concentrations that were below the lower limit of quantification (\<15 ng/mL) were set to 7.5 ng/mL for analyses.||||<.001
72477375|NCT05180500|144480719|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Concentrations that were below the lower limit of quantification (\<15 ng/mL) were set to 7.5 ng/mL for analyses.||||<.001
72477376|NCT05180500|144480720|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
72477377|NCT02317432|144480728|SUPERIORITY||Slope|-0.12|||<|0.01|TWO_SIDED|||||Threshold for statistical significance was p\<0.05|Mixed Models Analysis|||||||<0.01
72477378|NCT02317432|144480729|SUPERIORITY||Slope|0.6||||0.03|TWO_SIDED|||||Threshold for statistical significance was p\<0.05|Mixed Models Analysis|||||||0.03
72477379|NCT02317432|144480730|SUPERIORITY||Slope|6.0||||0.02|TWO_SIDED|||||Threshold for statistical significance was p\<0.05|Mixed Models Analysis|||||||0.02
72477380|NCT02317432|144480731|SUPERIORITY||Slope|-1.24||||0.15|TWO_SIDED|||||Threshold for statistical significance was p\<0.05|Mixed Models Analysis|||||||0.15
72477381|NCT02317432|144480732|SUPERIORITY||Slope|-0.49||||0.35|TWO_SIDED|||||Threshold for statistical significance was p\<0.05|Mixed Models Analysis|||||||0.35
72623346|NCT04562090|144777421|SUPERIORITY|Statistical testing was conducted using 2-sided at a significance level of 0.05.|LS Mean|-0.52|STANDARD_ERROR_OF_MEAN|0.04|<|0.001|TWO_SIDED|95.0|-0.6|-0.45||RMA: CFB as response, TG, visit (week 4, 8 and 12), pooled site, sex and the interaction between TG and visit as fixed effects and mean number of nighttime incontinence episodes per 24 hours at baseline as covariate.|MMRM|||Week 12||-0.45|-0.60|<0.001
72623347|NCT04562090|144777422|SUPERIORITY|Statistical testing was conducted using 2-sided at a significance level of 0.05.|LS Mean|-1.1|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-1.31|-0.9||RMA: CFB as response, treatment group, visit (week 4, 8 and 12), pooled site, sex and the interaction between treatment group and visit as fixed effects and mean number of urge incontinence episodes per 24 hours at baseline as covariate.|MMRM|||Week 4||-0.90|-1.31|<0.001
72477382|NCT03992846|144480742|OTHER|The criterion for defining a subject as a responder over the last 28 days of randomized treatment up to Month 3 was a reduction of 1.10 or greater from baseline pain for Dysmenorrhea (DYS).|Odds Ratio (OR)|2.56|||<|0.001|TWO_SIDED|97.5|1.46|4.49|||Bonferroni-corrected p-value|||||4.49|1.46|<0.001
72477383|NCT03992846|144480742|OTHER|The criterion for defining a subject as a responder over the last 28 days of randomized treatment up to Month 3 was a reduction of 1.10 or greater from baseline pain for Dysmenorrhea (DYS).|Odds Ratio (OR)|8.8|||<|0.001|TWO_SIDED|97.5|4.86|15.91|||Bonferroni-corrected p-value|||||15.91|4.86|<0.001
72477384|NCT03992846|144480743|OTHER|The criterion for defining a subject as a responder over the last 28 days of randomized treatment up to Month 3 was a reduction of 0.80 or greater from baseline pain for Non-Menstrual Pelvic Pain (NMPP).|Odds Ratio (OR)|1.43||||0.279|TWO_SIDED|97.5|0.83|2.45|||Bonferroni-corrected p-value|||||2.45|0.83|0.279
72477385|NCT03992846|144480743|OTHER|The criterion for defining a subject as a responder over the last 28 days of randomized treatment up to Month 3 was a reduction of 0.80 or greater from baseline pain for Non-Menstrual Pelvic Pain (NMPP).|Odds Ratio (OR)|2.01||||0.007|TWO_SIDED|97.5|1.18|3.42|||Bonferroni-corrected p-value|||||3.42|1.18|0.007
72477386|NCT03541174|144480776|SUPERIORITY||LS Mean difference to placebo|-3.79||||0.0042|TWO_SIDED|97.5|-6.76|-0.82||Mixed effects model for Repeated Measures: Change from baseline in SiSBP = baseline SiSBP + treatment + visit + treatment x visit + baseline x visit.|Mixed Models Analysis|||||-0.82|-6.76|0.0042
72477387|NCT03541174|144480776|SUPERIORITY||LS Mean difference to placebo|-3.73||||0.0046|TWO_SIDED|97.5|-6.67|-0.78||Mixed effects model for Repeated Measures: Change from baseline in SiSBP = baseline SiSBP + treatment + visit + treatment x visit + baseline x visit.|Mixed Models Analysis|||||-0.78|-6.67|0.0046
72477388|NCT03541174|144480777|SUPERIORITY||LS mean difference to placebo.|-5.82|||<|0.0001|TWO_SIDED|95.0|-7.94|-3.71||Mixed effects model for Repeated Measures: Change from DB-WD baseline in SiSBP = DB-WD baseline SiSBP + stratum (randomized treatment in DB part) + treatment + visit + treatment x visit + DB-WD baseline x visit.|Mixed Models Analysis|||||-3.71|-7.94|<0.0001
72477389|NCT03541174|144480778|OTHER||LS Mean difference to placebo|-3.94|||<|0.0001|TWO_SIDED|95.0|-5.57|-2.31||Mixed effects model for Repeated Measures: Change from baseline in SiDBP = baseline SiDBP + treatment + visit + treatment x visit + baseline x visit.|Mixed Models Analysis|||||-2.31|-5.57|<0.0001
72477390|NCT03541174|144480778|OTHER||LS Mean difference to placebo|-4.47|||<|0.0001|TWO_SIDED|95.0|-6.09|-2.85||Mixed effects model for Repeated Measures: Change from baseline in SiDBP = baseline SiDBP + treatment + visit + treatment x visit + baseline x visit.|Mixed Models Analysis|||||-2.85|-6.09|<0.0001
72477391|NCT03541174|144480779|OTHER||LS Mean difference to placebo|-4.18|||<|0.0001|TWO_SIDED|95.0|-6.25|-2.12|||ANCOVA|||24-hour mean systolic (SBP)||-2.12|-6.25|<0.0001
72477392|NCT03541174|144480779|OTHER||LS Mean difference to placebo|-5.9|||<|0.0001|TWO_SIDED|95.0|-7.94|-3.85|||ANCOVA|||24-hour mean systolic (SBP)||-3.85|-7.94|<0.0001
72477393|NCT03541174|144480779|OTHER||LS Mean difference to placebo|-4.32|||<|0.0001|TWO_SIDED|95.0|-5.66|-2.98|||ANCOVA|||24-hour mean diastolic (DBP)||-2.98|-5.66|<0.0001
72477394|NCT03541174|144480779|OTHER||LS Mean|-5.81|||<|0.0001|TWO_SIDED|95.0|-7.14|-4.49|||ANCOVA|||24-hour mean diastolic (DBP)||-4.49|-7.14|<0.0001
72477395|NCT03541174|144480780|OTHER||LS Mean difference to placebo|-5.19|||<|0.0001|TWO_SIDED|95.0|-6.62|-3.76||Mixed effects model for Repeated Measures: Change from DB-WD baseline in SiDBP = Double-blind withdrawal baseline SiDBP + stratum (randomized treatment in DB part) + treatment + visit + treatment x visit + Double-blind withdrawal baseline x visit.|Mixed Models Analysis|||||-3.76|-6.62|<0.0001
72477396|NCT03541174|144480781|OTHER||LS Mean difference to placebo|-6.53|||<|0.0001|TWO_SIDED|95.0|-8.5|-4.56|||ANCOVA|||24-hour mean systolic (SBP)||-4.56|-8.50|<0.0001
72477397|NCT03541174|144480781|OTHER||LSM Mean difference to placebo|-6.75|||<|0.0001|TWO_SIDED|95.0|-7.98|-5.52|||ANCOVA|||24-hour mean diastolic (DBP)||-5.52|-7.98|<0.0001
72477398|NCT02217332|144480784|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|Paired t-test comparing baseline to month 6 on log scale within the dexpramipexole treatment group.||Null hypothesis is the ratio of Month 6 to Baseline within the dexpramipexole group equals '1'.||||< 0.001
72477399|NCT02217332|144480785|SUPERIORITY|||||||0.885||||||Month 6/LOCF was used for the analysis of change from Baseline to Month 6 within the dexpramipexole group.|t-test, 2 sided|||||||0.885
72477400|NCT02217332|144480789|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|Paired t-test comparing baseline to month 3 on log scale within the dexpramipexole treatment group.||Null hypothesis is the ratio of Month 3 to Baseline within the dexpramipexole group equals '1'.||||<.001
72399694|NCT03997383|144306779|SUPERIORITY||Hazard Ratio (HR)|0.883||||0.5609|TWO_SIDED|95.0|0.582|1.341|||Modified Andersen-Gill|P-value was derived using the modified Andersen-Gill model stratified by baseline tafamidis use.|HR was derived using the modified Andersen-Gill model stratified by baseline tafamidis use, including treatment arm, type of ATTR amyloidosis, baseline NYHA class, and age as covariates.|||1.341|0.582|0.5609
72399695|NCT06273124|144306880|SUPERIORITY||Kaplan-Meier 7 Day Survival Estimate|95.0|||<|0.001|TWO_SIDED|95.0|94.0|97.0|||Bootstrapping Kaplan-Meier estimates|||Ninety-five percent confidence intervals for the 7-day survival rates and p-values for the survival probabilities being greater than 75% were calculated with a bootstrap to account for the correlated data from having each participant wear multiple infusion sets.||97|94|<0.001
72399696|NCT06273124|144306881|SUPERIORITY||Kaplan-Meier 7 Day Survival Estimate|95.0|||<|0.001|TWO_SIDED|95.0|93.0|96.0|||Bootstrapping Kaplan-Meier estimates|||Ninety-five percent confidence intervals for the 7-day survival rates and p-values for the survival probabilities being greater than 75% were calculated with a bootstrap to account for the correlated data from having each participant wear multiple infusion sets.||96|93|<0.001
72399697|NCT04103892|144306882|SUPERIORITY||Least square (LS) mean difference|-1.26|STANDARD_ERROR_OF_MEAN|1.69||0.46|TWO_SIDED|95.0|-4.6|2.09|||Mixed Models Repeated Measures (MMRM|||||2.09|-4.60|0.46
72399698|NCT04103892|144306883|SUPERIORITY||Least square (LS) mean difference|-5.28|STANDARD_ERROR_OF_MEAN|2.34||0.03|TWO_SIDED|95.0|-9.91|-0.65|||Mixed Models Repeated Measures (MMRM)|||||-0.65|-9.91|0.03
72399699|NCT03341533|144306911|EQUIVALENCE|The null hypothesis is that there is no difference in NPIS between the two groups.|difference in medians|0.0||||0.39|TWO_SIDED||||||Kruskal-Wallis|||||||0.39
72477401|NCT02217332|144480790|SUPERIORITY|||||||1||||||Month 3/LOCF was used for the analysis of change from Baseline to Month 3 within the dexpramipexole group.|t-test, 2 sided|Paired t-test comparing baseline to month 3 within the dexpramipexole treatment group||||||1.0
72477402|NCT02217332|144480791|SUPERIORITY||log scale|||||0.001|||||||Wilcoxon Signed Rank Test (paired)|||Null hypothesis is the ratio of Month 6 to Baseline within the dexpramipexole group equals '1'; 68% confidence interval is equal to plus/minus 1 standard error||||0.001
72477403|NCT04433585|144480819|SUPERIORITY||Odds Ratio (OR)|1.46||||0.309|TWO_SIDED|95.0|0.7|3.04|||Regression, Logistic|||||3.04|0.70|0.309
72508717|NCT02749721|144548161|OTHER||Pearson's R|0.073||||0.788|TWO_SIDED||||||Pearson's correlation|||Correlation between DSST and VGNG P200 (Latency) baseline to endpoint percentage change||||0.788
72508718|NCT02749721|144548161|OTHER||Pearson's R|0.375||||0.168|TWO_SIDED||||||Pearson's correlation|||Correlation between DSST and VGNG P3a (Latency) baseline to endpoint percentage change||||0.168
72399700|NCT03341533|144306912|EQUIVALENCE|The null hypothesis is that there is no difference in MME use on the hospital floor between groups.|Difference of medians|-4.5||||0.88|TWO_SIDED||||||Kruskal-Wallis||Ice packs - Usual care|||||0.88
72477404|NCT04433585|144480819|SUPERIORITY||Odds Ratio (OR)|0.97||||0.944|TWO_SIDED|95.0|0.47|2.03|||Regression, Logistic|||||2.03|0.47|0.944
72508719|NCT02749721|144548161|OTHER||Pearson's R|-0.392||||0.108|TWO_SIDED||||||Pearson's correlation|||Correlation between MADRS and AOB P200 (Latency) baseline scores||||0.108
72508720|NCT02749721|144548161|OTHER||Pearson's R|0.415||||0.124|TWO_SIDED||||||Pearson's correlation|||Correlation between MADRS and AOB P3a (Latency) baseline scores||||0.124
72508721|NCT02749721|144548161|OTHER||Pearson's R|0.362||||0.185|TWO_SIDED||||||Pearson's correlation|||Correlation between MADRS and AOB P3b (Latency) baseline scores||||0.185
72508722|NCT02749721|144548161|OTHER||Pearson's R|-0.023||||0.923|TWO_SIDED||||||Pearson's correlation|||Correlation between MADRS and VGNG P200 (Latency) baseline scores||||0.923
72399701|NCT03341533|144306913|EQUIVALENCE|The null hypothesis is that the outpatient MME consumption will be the same across the two groups.|difference in medians|-7.5||||0.75|TWO_SIDED||||||Kruskal-Wallis||Ice packs - Usual Care|||||0.75
72399702|NCT03341533|144306914|EQUIVALENCE|The null hypothesis is that the postoperative BPI pain severity score will be the same between groups|difference in medians|-0.3||||0.8|TWO_SIDED||||||Kruskal-Wallis||Ice Packs - Usual Care|||||0.80
72399703|NCT00399360|144306983|SUPERIORITY_OR_OTHER|||||||0.37||95.0|||||ANOVA|||||||0.37
72399704|NCT00399360|144306984|SUPERIORITY_OR_OTHER|||||||0.8||95.0|||||ANOVA|||||||0.80
72399705|NCT00399360|144306985|SUPERIORITY_OR_OTHER|||||||0.08||95.0|||||ANOVA|||||||0.08
72399706|NCT00399360|144306986|SUPERIORITY_OR_OTHER|||||||0.13||95.0|||||ANOVA|||||||0.13
72399707|NCT00399360|144306987|SUPERIORITY_OR_OTHER|||||||0.85||95.0|||||ANOVA|||||||0.85
72399708|NCT00399360|144306988|SUPERIORITY_OR_OTHER|||||||0.03||95.0|||||ANOVA|||||||0.03
72399709|NCT00399360|144306989|SUPERIORITY_OR_OTHER|||||||0.1||95.0|||||ANOVA|||||||0.10
72399710|NCT00399360|144306990|SUPERIORITY_OR_OTHER|||||||0.63||95.0|||||ANOVA|||||||0.63
72399711|NCT00399360|144306991|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANOVA|||||||0.05
72399712|NCT00399360|144306992|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||ANOVA|||||||0.02
72399713|NCT01412021|144306993|SUPERIORITY||||||<|0.0001|||||||paired t-test|redundancy is not taken into consideration||||||< 0.0001
72399714|NCT01412021|144306994|SUPERIORITY||||||<|0.0001|||||||paired t-test|redundancy is not taken into consideration||||||< 0.0001
72399715|NCT01412021|144306995|SUPERIORITY||||||<|0.0001|||||||paired t-test|redundancy is not taken into consideration||||||< 0.0001
72399716|NCT01412021|144306996|SUPERIORITY||||||<|0.0001|||||||paired t-test|redundancy is not taken into consideration||||||< 0.0001
72477405|NCT04433585|144480819|SUPERIORITY||Odds Ratio (OR)|0.84||||0.649|TWO_SIDED|95.0|0.4|1.78|||Regression, Logistic|||||1.78|0.40|0.649
72477406|NCT04433585|144480820|SUPERIORITY||Odds Ratio (OR)|1.89||||0.131|TWO_SIDED|95.0|0.83|4.3|||Regression, Logistic|||||4.30|0.83|0.131
72477407|NCT04433585|144480820|SUPERIORITY||Odds Ratio (OR)|1.09||||0.844|TWO_SIDED|95.0|0.47|2.5|||Regression, Logistic|||||2.50|0.47|0.844
72477408|NCT04433585|144480820|SUPERIORITY||Odds Ratio (OR)|0.57||||0.218|TWO_SIDED|95.0|0.24|1.39|||Regression, Logistic|||||1.39|0.24|0.218
72477409|NCT04433585|144480821|SUPERIORITY||Odds Ratio (OR)|0.97||||0.944|TWO_SIDED|95.0|0.47|2.03|||Regression, Logistic|||||2.03|0.47|0.944
72477410|NCT04433585|144480821|SUPERIORITY||Odds Ratio (OR)|1.46||||0.309|TWO_SIDED|95.0|0.7|3.04|||Regression, Logistic|||||3.04|0.70|0.309
72508723|NCT02749721|144548161|OTHER||Pearson's R|0.071||||0.77|TWO_SIDED||||||Pearson's correlation|||Correlation between MADRS and VGNG P3a (Latency) baseline scores||||0.77
72508724|NCT02749721|144548161|OTHER||Pearson's R|0.097||||0.712|TWO_SIDED||||||Pearson's correlation|||Correlation between MADRS and AOB P200 (Latency) baseline to endpoint percent change||||0.712
72508725|NCT02749721|144548161|OTHER||Pearson's R|-0.058||||0.845|TWO_SIDED||||||Pearson's correlation|||Correlation between MADRS and AOB P3a (Latency) baseline to endpoint percent change||||0.845
72508726|NCT02749721|144548161|OTHER||Pearson's R|0.194||||0.616|TWO_SIDED||||||Pearson's correlation|||Correlation between MADRS and AOB P3b (Latency) baseline to endpoint percent change||||0.616
72508727|NCT02749721|144548161|OTHER||Pearson's R|0.255||||0.323|TWO_SIDED||||||Pearson's correlation|||Correlation between MADRS and VGNG P200 (Latency) baseline to endpoint percent change||||0.323
72508728|NCT02749721|144548161|OTHER||Pearson's R|-0.193||||0.473|TWO_SIDED||||||Pearson's correlation|||Correlation between MADRS and VGNG P3a (Latency) baseline to endpoint percent change||||0.473
72508729|NCT02749721|144548161|OTHER||F statistic|4.909||||0.031|TWO_SIDED||||||ANCOVA|||"A comparison between vortioxetine arm patients' and healthy controls' AOB P200 latencies at baseline.~The healthy control group subjects have been previously documented in NCT02418208 (Clinical trials of the Rockies, Inc. Denver, Colorado, US and Clinical Research Center of Nevada Las Vegas, Nevada, US ) and in NCT02875496 (The Villages Health, The Villages, Florida, US)."||||0.031
72623348|NCT04562090|144777422|SUPERIORITY|Statistical testing was conducted using 2-sided at a significance level of 0.05.|LS Mean|-1.11|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|95.0|-1.25|-0.96||RMA: CFB as response, treatment group, visit (week 4, 8 and 12), pooled site, sex and the interaction between treatment group and visit as fixed effects and mean number of urge incontinence episodes per 24 hours at baseline as covariate.|MMRM|||Week 4||-0.96|-1.25|<0.001
72477411|NCT04433585|144480821|SUPERIORITY||Odds Ratio (OR)|0.84||||0.649|TWO_SIDED|95.0|0.4|1.78|||Regression, Logistic|||||1.78|0.40|0.649
72477412|NCT04433585|144480822|SUPERIORITY||Odds Ratio (OR)|1.91||||0.203|TWO_SIDED|95.0|0.71|5.2|||Regression, Logistic|||||5.20|0.71|0.203
72477413|NCT04433585|144480822|SUPERIORITY||Odds Ratio (OR)|1.1||||0.865|TWO_SIDED|95.0|0.38|3.16|||Regression, Logistic|||||3.16|0.38|0.865
72477414|NCT04433585|144480822|SUPERIORITY||Odds Ratio (OR)|1.07||||0.896|TWO_SIDED|95.0|0.38|3.05|||Regression, Logistic|||||3.05|0.38|0.896
72477415|NCT02937454|144480832|OTHER||Annualised event rate ratio (RR)|0.79||||0.059|TWO_SIDED|95.0|0.62|1.01|||Negative binomial model|Negative binomial model adjusted for baseline covariates: sex, age, HF aetiology, HF duration, and country.||Full Analysis Set (FAS)||1.01|0.62|0.059
72477416|NCT02937454|144480832|OTHER||Annualised event rate ratio (RR)|0.75||||0.024|TWO_SIDED|95.0|0.59|0.96|||Negative binomial model|Negative binomial model adjusted for baseline covariates: sex, age, HF aetiology, HF duration, and country.||Covid-19 Sensitivity Analysis||0.96|0.59|0.024
72477417|NCT02937454|144480833|OTHER||Annualised event rate ratio (RR)|0.8||||0.05|TWO_SIDED|95.0|0.64|1.0|||Negative binomial model|Negative binomial model adjusted for baseline covariates: sex, age, HF aetiology, HF duration, and country.||Full Analysis Set (FAS)||1.0|0.64|0.050
72508730|NCT02749721|144548161|OTHER||F statistic|1.189||||0.281|TWO_SIDED||||||ANCOVA|||"A comparison between vortioxetine arm patients' and healthy controls' AOB P200 latencies at Endpoint.~The healthy control group subjects have been previously documented in NCT02418208 (Clinical trials of the Rockies, Inc. Denver, Colorado, US and Clinical Research Center of Nevada Las Vegas, Nevada, US ) and in NCT02875496 (The Villages Health, The Villages, Florida, US)."||||0.281
72623349|NCT04562090|144777422|SUPERIORITY|Statistical testing was conducted using 2-sided at a significance level of 0.05.|LS Mean|-1.26|STANDARD_ERROR_OF_MEAN|0.14|<|0.001|TWO_SIDED|95.0|-1.53|-0.99||RMA: CFB as response, treatment group, visit (week 4, 8 and 12), pooled site, sex and the interaction between treatment group and visit as fixed effects and mean number of urge incontinence episodes per 24 hours at baseline as covariate.|MMRM|||Week 8||-0.99|-1.53|<0.001
72477418|NCT02937454|144480833|OTHER||Annualised event rate ratio (RR)|0.77||||0.024|TWO_SIDED|95.0|0.62|0.97|||Negative binomial model|Negative binomial model adjusted for baseline covariates: sex, age, HF aetiology, HF duration, and country.||COVID-19 sensitivity analyses||0.97|0.62|0.024
72477419|NCT02937454|144480834|OTHER||Annualised event rate ratio (RR)|0.74||||0.013|TWO_SIDED|95.0|0.58|0.94|||Negative binomial model|Negative binomial model adjusted for baseline covariates: sex, age, HF aetiology, HF duration, and country.||Full Analysis Set (FAS)||0.94|0.58|0.013
72477420|NCT02937454|144480834|OTHER||Annualised event rate ratio (RR)|0.7||||0.005|TWO_SIDED|95.0|0.55|0.9|||Negative binomial model|Negative binomial model adjusted for baseline covariates: sex, age, HF aetiology, HF duration, and country.||COVID-19 sensitivity analyses||0.90|0.55|0.005
72477421|NCT02937454|144480835|OTHER||Hazard Ratio (HR)|0.96||||0.809|TWO_SIDED|95.0|0.7|1.32|||Regression, Cox|Cox regression adjusted for sex, age, HF aetiology, HF duration, and country at baseline.||Full Analysis Set (FAS)||1.32|0.70|0.809
72477422|NCT02937454|144480835|OTHER||Hazard Ratio (HR)|0.94||||0.687|TWO_SIDED|95.0|0.68|1.29|||Regression, Cox|Cox regression adjusted for sex, age, HF aetiology, HF duration, and country at baseline||Covid-19 Sensitivity Analysis||1.29|0.68|0.687
72477423|NCT02937454|144480836|OTHER||Hazard Ratio (HR)|0.8||||0.03|TWO_SIDED|95.0|0.66|0.98|||Regression, Cox|Cox regression adjusted for sex, age, HF aetiology, HF duration, and country at baseline||Full Analysis Set (FAS)||0.98|0.66|0.030
72508731|NCT02749721|144548161|OTHER||F statistic|0.001||||0.966|TWO_SIDED||||||ANCOVA|||"A comparison between vortioxetine arm patients' and healthy controls' AOB P3a latencies at baseline.~The healthy control group subjects have been previously documented in NCT02418208 (Clinical trials of the Rockies, Inc. Denver, Colorado, US and Clinical Research Center of Nevada Las Vegas, Nevada, US ) and in NCT02875496 (The Villages Health, The Villages, Florida, US)."||||0.966
72508732|NCT02749721|144548161|OTHER||F statistic|4.121||||0.048|TWO_SIDED||||||ANCOVA|||"A comparison between vortioxetine arm patients' and healthy controls' AOB P3a latencies at Endpoint.~The healthy control group subjects have been previously documented in NCT02418208 (Clinical trials of the Rockies, Inc. Denver, Colorado, US and Clinical Research Center of Nevada Las Vegas, Nevada, US ) and in NCT02875496 (The Villages Health, The Villages, Florida, US)."||||0.048
72508733|NCT02749721|144548161|OTHER||F statistic|8.573||||0.005|TWO_SIDED||||||ANCOVA|||"A comparison between vortioxetine arm patients' and healthy controls' AOB P3b latencies at baseline.~The healthy control group subjects have been previously documented in NCT02418208 (Clinical trials of the Rockies, Inc. Denver, Colorado, US and Clinical Research Center of Nevada Las Vegas, Nevada, US ) and in NCT02875496 (The Villages Health, The Villages, Florida, US)."||||0.005
72477424|NCT02937454|144480836|OTHER||Hazard Ratio (HR)|0.79||||0.023|TWO_SIDED|95.0|0.65|0.97|||Regression, Cox|Cox regression adjusted for sex, age, HF aetiology, HF duration, and country at baseline||Covid-19 Sensitivity Analysis||0.97|0.65|0.023
72477425|NCT02937454|144480837|OTHER||Annualised event rate ratio (RR)|0.67||||0.035|TWO_SIDED|95.0|0.47|0.97|||Negative binomial model|Negative binomial model adjusted for baseline covariates: sex, age, HF aetiology, HF duration, and country.||Full Analysis Set (FAS)||0.97|0.47|0.035
72477426|NCT02937454|144480837|OTHER||Annualised event rate ratio (RR)|0.61||||0.009|TWO_SIDED|95.0|0.42|0.88|||Negative binomial model|Negative binomial model adjusted for baseline covariates: sex, age, HF aetiology, HF duration, and country||Covid-19 Sensitivity Analysis||0.88|0.42|0.009
72477427|NCT02937454|144480838|OTHER||Hazard Ratio (HR)|0.73||||0.006|TWO_SIDED|95.0|0.59|0.92|||Regression, Cox|Cox regression adjusted for sex, age, HF aetiology, HF duration, and country at baseline.||Full Analysis Set (FAS)||0.92|0.59|0.006
72477428|NCT02937454|144480839|OTHER||Hazard Ratio (HR)|0.77||||0.009|TWO_SIDED|95.0|0.63|0.94|||Regression, Cox|Cox regression adjusted for sex, age, HF aetiology, HF duration, and country at baseline.||Full Analysis Set (FAS)||0.94|0.63|0.009
72477429|NCT02937454|144480840|OTHER||Hazard Ratio (HR)|0.99||||0.944|TWO_SIDED|95.0|0.75|1.31|||Regression, Cox|Cox regression adjusted for sex, age, HF aetiology, HF duration, and country at baseline||Full Analysis Set (FAS)||1.31|0.75|0.944
72477430|NCT02937454|144480841|OTHER||Odds Ratio (OR)|1.14||||0.196|TWO_SIDED|95.0|0.93|1.39|||Generalised Estimating Equations (GEE)|The following variables are included in the GEE model: treatment, visit, baseline NYHA class, sex, age, HF aetiology, HF duration, and country||Full Analysis Set (FAS)||1.39|0.93|0.196
72477431|NCT02937454|144480842|OTHER|||||||0.208|||||||Mixed-effect model of repeated measures|MMRM using unstructured covariance matrix: Change score = Baseline score + Treatment + Visit + Treatment\*Visit + Baseline covariates.||Week 6||||0.208
72508734|NCT02749721|144548161|OTHER||F statistic|2.823||||0.101|TWO_SIDED||||||ANCOVA|||"A comparison between vortioxetine arm patients' and healthy controls' AOB P3b latencies at Endpoint.~The healthy control group subjects have been previously documented in NCT02418208 (Clinical trials of the Rockies, Inc. Denver, Colorado, US and Clinical Research Center of Nevada Las Vegas, Nevada, US ) and in NCT02875496 (The Villages Health, The Villages, Florida, US)."||||0.101
72508735|NCT02749721|144548161|OTHER||F statistic|0.806||||0.373|TWO_SIDED||||||ANCOVA|||"A comparison between vortioxetine arm patients' and healthy controls' VGNG P200 latencies at baseline.~The healthy control group subjects have been previously documented in NCT02418208 (Clinical trials of the Rockies, Inc. Denver, Colorado, US and Clinical Research Center of Nevada Las Vegas, Nevada, US ) and in NCT02875496 (The Villages Health, The Villages, Florida, US)."||||0.373
72508736|NCT02749721|144548161|OTHER||F statistic|1.822||||0.183|TWO_SIDED||||||ANCOVA|||"A comparison between vortioxetine arm patients' and healthy controls' VGNG P200 latencies at Endpoint.~The healthy control group subjects have been previously documented in NCT02418208 (Clinical trials of the Rockies, Inc. Denver, Colorado, US and Clinical Research Center of Nevada Las Vegas, Nevada, US ) and in NCT02875496 (The Villages Health, The Villages, Florida, US)."||||0.183
72508737|NCT02749721|144548161|OTHER||F statistic|0.516||||0.475|TWO_SIDED||||||ANCOVA|||"A comparison between vortioxetine arm patients' and healthy controls' VGNG P3a latencies at baseline.~The healthy control group subjects have been previously documented in NCT02418208 (Clinical trials of the Rockies, Inc. Denver, Colorado, US and Clinical Research Center of Nevada Las Vegas, Nevada, US ) and in NCT02875496 (The Villages Health, The Villages, Florida, US)."||||0.475
72477432|NCT02937454|144480842|OTHER|||||||0.408|||||||Mixed-effect model of repeated measures|MMRM using unstructured covariance matrix: Change score = Baseline score + Treatment + Visit + Treatment\*Visit + Baseline covariates.||Week 24||||0.408
72477433|NCT02937454|144480842|OTHER|||||||0.999|||||||Mixed-effect model of repeated measures|MMRM using unstructured covariance matrix: Change score = Baseline score + Treatment + Visit + Treatment\*Visit + Baseline covariates.||Week 52||||0.999
72477434|NCT02937454|144480843|OTHER|||||||0.227|||||||Mixed-effect model of repeated measures|MMRM using unstructured covariance matrix: Change score = Baseline score + Treatment + Visit + Treatment\*Visit + Baseline covariates.||Week 2||||0.227
72477435|NCT02937454|144480843|OTHER|||||||0.018|||||||Mixed-effect model of repeated measures|MMRM using unstructured covariance matrix: Change score = Baseline score + Treatment + Visit + Treatment\*Visit + Baseline covariates.||Week 4||||0.018
72477436|NCT02937454|144480843|OTHER|||||||0.005|||||||Mixed-effect model of repeated measures|MMRM using unstructured covariance matrix: Change score = Baseline score + Treatment + Visit + Treatment\*Visit + Baseline covariates.||Week 6||||0.005
72477437|NCT02937454|144480843|OTHER|||||||0.006|||||||Mixed-effect model of repeated measures|MMRM using unstructured covariance matrix: Change score = Baseline score + Treatment + Visit + Treatment\*Visit + Baseline covariates.||Week 12||||0.006
72477438|NCT02937454|144480843|OTHER|||||||0.028|||||||Mixed-effect model of repeated measures|MMRM using unstructured covariance matrix: Change score = Baseline score + Treatment + Visit + Treatment\*Visit + Baseline covariates.||Week 24||||0.028
72477439|NCT02937454|144480843|OTHER|||||||0.136|||||||Mixed-effect model of repeated measures|MMRM using unstructured covariance matrix: Change score = Baseline score + Treatment + Visit + Treatment\*Visit + Baseline covariates.||Week 36||||0.136
72477440|NCT02937454|144480843|OTHER|||||||0.329|||||||Mixed-effect model of repeated measures|MMRM using unstructured covariance matrix: Change score = Baseline score + Treatment + Visit + Treatment\*Visit + Baseline covariates.||Week 52||||0.329
72477441|NCT01639560|144480859|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.7|||<|0.001|TWO_SIDED|95.0|2.5|18.1|||Regression, Logistic|||||18.1|2.5|<0.001
72477442|NCT01639560|144480860|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|7.33||||0.001|TWO_SIDED|95.0|2.2|24.0|||Regression, Logistic|||||24.0|2.2|0.001
72477443|NCT01639560|144480861|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.5||||0.047|TWO_SIDED|95.0|1.0|6.3|||Regression, Logistic|||||6.3|1.0|0.047
72508738|NCT02749721|144548161|OTHER||F statistic|0.214||||0.645|TWO_SIDED||||||ANCOVA|||"A comparison between vortioxetine arm patients' and healthy controls' VGNG P3a latencies at Endpoint.~The healthy control group subjects have been previously documented in NCT02418208 (Clinical trials of the Rockies, Inc. Denver, Colorado, US and Clinical Research Center of Nevada Las Vegas, Nevada, US ) and in NCT02875496 (The Villages Health, The Villages, Florida, US)."||||0.645
72508739|NCT02749721|144548162|OTHER||||||<|0.001|||||||Paired t-test|||||||<0.001
72508740|NCT02749721|144548163|OTHER||||||<|0.001|||||||Paired t-test|||||||<0.001
72508741|NCT02749721|144548164|OTHER||||||<|0.001|||||||Paired t-test|||||||<0.001
72477444|NCT01639560|144480862|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.0||||0.009|TWO_SIDED|95.0|1.5|16.5|||Regression, Logistic|||||16.5|1.5|0.009
72477445|NCT01160289|144480863|SUPERIORITY_OR_OTHER|||||||0.5||95.0||||The p-value was 1-sided and adjusted for multiple comparisons. The level of significance was 1-sided of 0.04.|ANCOVA|Treatment group (tx grp), baseline IIEF EF domain score, baseline testosterone level, tx grp\*baseline IIEF, tx grp\*testosterone level interactions.||Only the treatment effects of 1 mg LY2452473 and 5 mg tadalafil versus 5 mg tadalafil and the treatment effects of 5 mg LY2452473 and 5 mg tadalafil versus 5 mg tadalafil were analyzed.||||0.5
72477446|NCT01160289|144480863|SUPERIORITY_OR_OTHER|||||||0.498||95.0||||The p-value was 1-sided and adjusted for multiple comparisons. The level of significance was 1-sided of 0.04.|ANCOVA|The model included tx grp, baseline IIEF EF domain score, baseline testosterone level, tx grp\*baseline IIEF, tx grp\*testosterone level interactions.||Only the treatment effects of the treatment effects of 5 mg LY2452473 and 5 mg tadalafil versus 5 mg tadalafil and 1 mg LY2452473 and 5 mg tadalafil versus 5 mg tadalafil were analyzed.||||0.498
72477447|NCT01160289|144480864|SUPERIORITY_OR_OTHER||LS mean of treatment difference|1.178|STANDARD_ERROR_OF_MEAN|3.312||0.722||95.0||||"The p-value is for the change from baseline to Week 12 in the percentage of Yes responses on the SEP diary, Q1; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity."|Mixed model repeated measures analysis|||||||0.722
72477448|NCT01160289|144480864|SUPERIORITY_OR_OTHER||LS mean of treatment difference|-1.552|STANDARD_ERROR_OF_MEAN|3.253||0.634||95.0||||"The p-value is for the change from baseline to Week 12 in the percentage of Yes responses on the SEP diary, Q1; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity."|Mixed model repeated measures analysis|||||||0.634
72477449|NCT01160289|144480864|SUPERIORITY_OR_OTHER||LS mean of treatment difference|-4.674|STANDARD_ERROR_OF_MEAN|3.218||0.147||95.0||||"The p-value is for the change from baseline to Week 12 in the percentage of Yes responses on the SEP diary, Q1; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity."|Mixed model repeated measures analysis|||||||0.147
72477450|NCT01160289|144480864|SUPERIORITY_OR_OTHER||LS mean of treatment difference|-7.404|STANDARD_ERROR_OF_MEAN|3.157||0.02||95.0||||"The p-value is for the change from baseline to Week 12 in the percentage of Yes responses on the SEP diary, Q1; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity."|Mixed model repeated measures analysis|||||||0.020
72508742|NCT02749721|144548165|OTHER||||||<|0.001|||||||Paired t-test|||||||<0.001
72508743|NCT02749721|144548166|OTHER||Pearson's R|-0.044||||0.859|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P200 (amplitude) and HDRS-28 baseline scores||||0.859
72477451|NCT01160289|144480864|SUPERIORITY_OR_OTHER||LS mean of treatment difference|1.33|STANDARD_ERROR_OF_MEAN|4.658||0.775||95.0||||"The p-value is for the change from baseline to Week 12 in the percentage of Yes responses on the SEP diary, Q2; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity."|Mixed model repeated measures analysis|||||||0.775
72477452|NCT01160289|144480864|SUPERIORITY_OR_OTHER||LS mean of treatment difference|1.844|STANDARD_ERROR_OF_MEAN|4.573||0.687||95.0||||"The p-value is for the change from baseline to Week 12 in the percentage of Yes responses on the SEP diary, Q2; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity."|Mixed model repeated measures analysis|||||||0.687
72477453|NCT01160289|144480864|SUPERIORITY_OR_OTHER||LS mean of treatment difference|-7.092|STANDARD_ERROR_OF_MEAN|4.535||0.119||95.0||||"The p-value is for the change from baseline to Week 12 in the percentage of Yes responses on the SEP diary, Q2; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity."|Mixed model repeated measures analysis|||||||0.119
72477454|NCT01160289|144480864|SUPERIORITY_OR_OTHER||LS mean of treatment difference|-6.578|STANDARD_ERROR_OF_MEAN|4.45||0.14||95.0||||"The p-value is for the change from baseline to Week 12 in the percentage of Yes responses on the SEP diary, Q2; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity."|Mixed model repeated measures analysis|||||||0.140
72477455|NCT01160289|144480864|SUPERIORITY_OR_OTHER||LS mean of treatment difference|6.703|STANDARD_ERROR_OF_MEAN|5.302||0.207||95.0||||"The p-value is for the change from baseline to Week 12 in the percentage of Yes responses on the SEP diary, Q3; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity."|Mixed model repeated measures analysis|||||||0.207
72477456|NCT01160289|144480864|SUPERIORITY_OR_OTHER||LS mean of treatment difference|9.159|STANDARD_ERROR_OF_MEAN|5.206||0.079||95.0||||"The p-value is for the change from baseline to Week 12 in the percentage of Yes responses on the SEP diary, Q3; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity."|Mixed model repeated measures analysis|||||||0.079
72477457|NCT01160289|144480864|SUPERIORITY_OR_OTHER||LS mean of treatment difference|-5.349|STANDARD_ERROR_OF_MEAN|5.165||0.301||95.0||||"The p-value is for the change from baseline to Week 12 in the percentage of Yes responses on the SEP diary, Q3; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity."|Mixed model repeated measures analysis|||||||0.301
72477458|NCT01160289|144480864|SUPERIORITY_OR_OTHER||LS mean of treatment difference|-2.893|STANDARD_ERROR_OF_MEAN|5.067||0.568||95.0||||"The p-value is for the change from baseline to Week 12 in the percentage of Yes responses on the SEP diary, Q3; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity."|Mixed model repeated measures analysis|||||||0.568
72508744|NCT02749721|144548166|OTHER||Pearson's R|-0.211||||0.451|TWO_SIDED||||||Pearson's correlation|||AOB P3a (amplitude)||||0.451
72508745|NCT02749721|144548166|OTHER||Pearson's R|0.015||||0.957|TWO_SIDED||||||Pearson's correlation|||AOB P3b (amplitude)||||0.957
72508746|NCT02749721|144548166|OTHER||Pearson's R|-0.322||||0.166|TWO_SIDED||||||Pearson's correlation|||VGNG P200 (amplitude)||||0.166
72508747|NCT02749721|144548166|OTHER||Pearson's R|-0.374||||0.105|TWO_SIDED||||||Pearson's correlation|||VGNG P3a (amplitude)||||0.105
72508748|NCT02749721|144548166|OTHER||Pearson's R|-0.137||||0.601|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P200 (amplitude) and HDRS-28 baseline to endpoint percent change||||0.601
72508749|NCT02749721|144548166|OTHER||Pearson's R|-0.234||||0.421|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P3a (amplitude) and HDRS-28 baseline to endpoint percent change||||0.421
72508750|NCT02749721|144548166|OTHER||Pearson's R|0.378||||0.316|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P3b (amplitude) and HDRS-28 baseline to endpoint percent change||||0.316
72477459|NCT01160289|144480864|SUPERIORITY_OR_OTHER||LS mean of treatment difference|4.079|STANDARD_ERROR_OF_MEAN|5.566||0.464||95.0||||"The p-value is for the change from baseline to Week 12 in the percentage of Yes responses on the SEP diary, Q4; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity."|Mixed model repeated measures analysis|||||||0.464
72477460|NCT01160289|144480864|SUPERIORITY_OR_OTHER||LS mean of treatment difference|5.054|STANDARD_ERROR_OF_MEAN|5.463||0.356||95.0||||"The p-value is for the change from baseline to Week 12 in the percentage of Yes responses on the SEP diary, Q4; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity."|Mixed model repeated measures analysis|||||||0.356
72477461|NCT01160289|144480864|SUPERIORITY_OR_OTHER||LS mean of treatment difference|-11.266|STANDARD_ERROR_OF_MEAN|5.418||0.038||95.0||||"The p-value is for the change from baseline to Week 12 in the percentage of Yes responses on the SEP diary, Q4; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity."|Mixed model repeated measures analysis|||||||0.038
72477462|NCT01160289|144480864|SUPERIORITY_OR_OTHER||LS mean of treatment difference|-10.292|STANDARD_ERROR_OF_MEAN|5.312||0.054||95.0||||"The p-value is for the change from baseline to Week 12 in the percentage of Yes responses on the SEP diary, Q4; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity."|Mixed model repeated measures analysis|||||||0.054
72477463|NCT01160289|144480864|SUPERIORITY_OR_OTHER||LS mean of treatment difference|4.202|STANDARD_ERROR_OF_MEAN|5.603||0.454||95.0||||"The p-value is for the change from baseline to Week 12 in the percentage of Yes responses on the SEP diary, Q5; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity."|Mixed model repeated measures analysis|||||||0.454
72477464|NCT01160289|144480864|SUPERIORITY_OR_OTHER||LS mean of treatment difference|5.796|STANDARD_ERROR_OF_MEAN|5.499||0.293||95.0||||"The p-value is for the change from baseline to Week 12 in the percentage of Yes responses on the SEP diary, Q5; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity."|Mixed model repeated measures analysis|||||||0.293
72477465|NCT01160289|144480864|SUPERIORITY_OR_OTHER||LS mean of treatment difference|-8.808|STANDARD_ERROR_OF_MEAN|5.457||0.107||95.0||||"The p-value is for the change from baseline to Week 12 in the percentage of Yes responses on the SEP diary, Q5; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity."|Mixed model repeated measures analysis|||||||0.107
72477466|NCT01160289|144480864|SUPERIORITY_OR_OTHER||LS mean of treatment difference|-7.214|STANDARD_ERROR_OF_MEAN|5.349||0.178||95.0||||"The p-value is for the change from baseline to Week 12 in the percentage of Yes responses on the SEP diary, Q5; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity."|Mixed model repeated measures analysis|||||||0.178
72477467|NCT01160289|144480865|SUPERIORITY_OR_OTHER||LS mean of treatment difference|-0.079|STANDARD_ERROR_OF_MEAN|0.472||0.867||95.0||||The p-value is for the change from baseline to Week 12 in the IIEF IS domain score; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed model repeated measures analysis|||||||0.867
72477468|NCT01160289|144480865|SUPERIORITY_OR_OTHER||LS mean of treatment difference|-0.039|STANDARD_ERROR_OF_MEAN|0.458||0.931||95.0||||The p-value is for the change from baseline to Week 12 in the IIEF IS domain score; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed model repeated measures analysis|||||||0.931
72508751|NCT02749721|144548166|OTHER||Pearson's R|0.185||||0.478|TWO_SIDED||||||Pearson's correlation|||||||0.478
72399717|NCT01412021|144306997|SUPERIORITY||||||<|0.0001|||||||paired t-test|redundancy is not taken into consideration||||||< 0.0001
72477469|NCT01160289|144480865|SUPERIORITY_OR_OTHER||LS mean of treatment difference|-0.652|STANDARD_ERROR_OF_MEAN|0.46||0.158||95.0||||The p-value is for the change from baseline to Week 12 in the IIEF IS domain score; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed model repeated measures analysis|||||||0.158
72477470|NCT01160289|144480865|SUPERIORITY_OR_OTHER||LS mean of treatment difference|-0.612|STANDARD_ERROR_OF_MEAN|0.447||0.172||95.0||||The p-value is for the change from baseline to Week 12 in the IIEF IS domain score; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed model repeated measures analysis|||||||0.172
72477471|NCT01160289|144480865|SUPERIORITY_OR_OTHER||LS mean of treatment difference|-0.223|STANDARD_ERROR_OF_MEAN|0.401||0.579||95.0||||The p-value is for the change from baseline to Week 12 in the IIEF OF domain score; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed model repeated measures analysis|||||||0.579
72477472|NCT01160289|144480865|SUPERIORITY_OR_OTHER||LS mean of treatment difference|-0.616|STANDARD_ERROR_OF_MEAN|0.39||0.115||95.0||||The p-value is for the change from baseline to Week 12 in the IIEF OF domain score; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed model repeated measures analysis|||||||0.115
72477473|NCT01160289|144480865|SUPERIORITY_OR_OTHER||LS mean of treatment difference|-0.168|STANDARD_ERROR_OF_MEAN|0.392||0.668||95.0||||The p-value is for the change from baseline to Week 12 in the IIEF OF domain score; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed model repeated measures analysis|||||||0.668
72477474|NCT01160289|144480865|SUPERIORITY_OR_OTHER||LS mean of treatment difference|-0.561|STANDARD_ERROR_OF_MEAN|0.38||0.141||95.0||||The p-value is for the change from baseline to Week 12 in the IIEF OF domain score; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed model repeated measures analysis|||||||0.141
72477475|NCT01160289|144480865|SUPERIORITY_OR_OTHER||LS mean of treatment difference|-0.088|STANDARD_ERROR_OF_MEAN|0.258||0.734||95.0||||The p-value is for the change from baseline to Week 12 in the IIEF SD domain score; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed model repeated measures analysis|||||||0.734
72477476|NCT01160289|144480865|SUPERIORITY_OR_OTHER||LS mean of treatment difference|-0.179|STANDARD_ERROR_OF_MEAN|0.251||0.477||95.0||||The p-value is for the change from baseline to Week 12 in the IIEF SD domain score; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed model repeated measures analysis|||||||0.477
72508752|NCT02749721|144548166|OTHER||Pearson's R|0.011||||0.969|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P3a (amplitude) and HDRS-28 baseline to endpoint percent change||||0.969
72508753|NCT02749721|144548166|OTHER||Pearson's R|-0.018||||0.943|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P200 (amplitude) and HDRS-17 baseline scores||||0.943
72508754|NCT02749721|144548166|OTHER||Pearson's R|-0.074||||0.795|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P3a (amplitude) and HDRS-17 baseline scores||||0.795
72399718|NCT01412021|144306999|SUPERIORITY||||||<|0.0001|||||||paired t-test|redundancy is not taken into consideration||||||< 0.0001
72399719|NCT01412021|144307001|SUPERIORITY||||||<|0.0001|||||||paired t-test|redundancy is not taken into consideration||||||< 0.0001
72477477|NCT01160289|144480865|SUPERIORITY_OR_OTHER||LS mean of treatment difference|-0.3|STANDARD_ERROR_OF_MEAN|0.252||0.235||95.0||||The p-value is for the change from baseline to Week 12 in the IIEF SD domain score; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed model repeated measures analysis|||||||0.235
72477478|NCT01160289|144480865|SUPERIORITY_OR_OTHER||LS mean of treatment difference|-0.391|STANDARD_ERROR_OF_MEAN|0.245||0.111||95.0||||The p-value is for the change from baseline to Week 12 in the IIEF SD domain score; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed model repeated measures analysis|||||||0.111
72477479|NCT01160289|144480865|SUPERIORITY_OR_OTHER||LS mean of treatment difference|-0.349|STANDARD_ERROR_OF_MEAN|0.343||0.31||95.0||||The p-value is for the change from baseline to Week 12 in the IIEF OS domain score; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed model repeated measures analysis|||||||0.310
72477480|NCT01160289|144480865|SUPERIORITY_OR_OTHER||LS mean of treatment difference|-0.568|STANDARD_ERROR_OF_MEAN|0.334||0.09||95.0||||The p-value is for the change from baseline to Week 12 in the IIEF OS domain score; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed model repeated measures analysis|||||||0.090
72477481|NCT01160289|144480865|SUPERIORITY_OR_OTHER||LS mean of treatment difference|-0.729|STANDARD_ERROR_OF_MEAN|0.335||0.03||95.0||||The p-value is for the change from baseline to Week 12 in the IIEF OS domain score; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed model repeated measures analysis|||||||0.030
72477482|NCT01160289|144480865|SUPERIORITY_OR_OTHER||LS mean of treatment difference|-0.948|STANDARD_ERROR_OF_MEAN|0.326||0.004||95.0||||The p-value is for the change from baseline to Week 12 in the IIEF OS domain score; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed model repeated measures analysis|||||||0.004
72477483|NCT01160289|144480867|SUPERIORITY_OR_OTHER|||||||0.656||||||The p-value is for the change from baseline to Week 12 in the IIEF EF domain scores reported by optimal testosterone level \<340 ng/dL; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|ANCOVA|||||||0.656
72477484|NCT01160289|144480867|SUPERIORITY_OR_OTHER|||||||0.46||||||The p-value is for the change from baseline to Week 12 in the IIEF EF domain scores reported by optimal testosterone level \<340 ng/dL; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|ANCOVA|||||||0.460
72508755|NCT02749721|144548166|OTHER||Pearson's R|-0.011||||0.969|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P3b (amplitude) and HDRS-17 baseline scores||||0.969
72566396|NCT02697773|144663267|SUPERIORITY||Odds Ratio (OR)|2.09||||0.0113|TWO_SIDED|95.0|1.18|3.68|||Regression, Logistic|||Week 12, \>=90%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.68|1.18|0.0113
72399720|NCT01412021|144307002|SUPERIORITY||||||<|0.0001|||||||paired t-test|redundancy is not taken into consideration||||||< 0.0001
72399721|NCT01412021|144307003|SUPERIORITY||||||<|0.0001|||||||paired t-test|||||||< 0.0001
72399722|NCT01412021|144307004|SUPERIORITY||||||<|0.0001|||||||paired t-test|||||||< 0.0001
72399723|NCT01412021|144307005|SUPERIORITY||||||<|0.0001|||||||paired t-test|||||||< 0.0001
72399724|NCT01412021|144307006|SUPERIORITY||||||<|0.0001|||||||paired t-test|||||||< 0.0001
72399725|NCT01412021|144307007|SUPERIORITY||||||<|0.0001|||||||paired t-test|||||||< 0.0001
72399726|NCT01412021|144307008|SUPERIORITY||||||<|0.0001|||||||paired t-test|||||||< 0.0001
72399727|NCT01412021|144307009|SUPERIORITY||||||<|0.0001|||||||paired t-test|||||||< 0.0001
72399728|NCT01412021|144307010|SUPERIORITY||||||<|0.0001|||||||paired t-test|||||||< 0.0001
72399729|NCT01412021|144307011|SUPERIORITY||||||<|0.0001|||||||paired t-test|||||||< 0.0001
72399730|NCT01412021|144307013|SUPERIORITY|||||||0.0132|||||||paired t-test|||||||0.0132
72477485|NCT01160289|144480867|SUPERIORITY_OR_OTHER|||||||0.198||95.0||||The p-value is for the change from baseline to Week 12 in the IIEF EF domain scores reported by optimal testosterone level \<340 ng/dL; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|ANCOVA|||||||0.198
72477486|NCT01160289|144480867|SUPERIORITY_OR_OTHER|||||||0.009||95.0||||The p-value is for the change from baseline to Week 12 in the IIEF EF domain scores reported by optimal testosterone level ≥340 ng/dL; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|ANCOVA|||||||0.009
72477487|NCT01160289|144480867|SUPERIORITY_OR_OTHER|||||||0.671||||||The p-value is for the change from baseline to Week 12 in the IIEF EF domain scores reported by optimal testosterone level ≥340 ng/dL; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|ANCOVA|||||||0.671
72477488|NCT01160289|144480867|SUPERIORITY_OR_OTHER|||||||0.259||||||The p-value is for the change from baseline to Week 12 in the IIEF EF domain scores reported by optimal testosterone level ≥340 ng/dL; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|ANCOVA|||||||0.259
72477489|NCT01160289|144480867|SUPERIORITY_OR_OTHER|||||||0.441||95.0||||The p-value is for the change from baseline to Week 12 in the IIEF EF domain scores reported by optimal testosterone level ≥340 ng/dL; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|ANCOVA|||||||0.441
72477490|NCT01160289|144480867|SUPERIORITY_OR_OTHER|||||||0.433||95.0||||The p-value is for the change from baseline to Week 12 in the IIEF EF domain scores reported by optimal testosterone level ≥340 ng/dL; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|ANCOVA|||||||0.433
72477491|NCT01160289|144480868|SUPERIORITY_OR_OTHER||LS mean of treatment difference|0.13||||0.423||95.0||||Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed model repeated measures analysis|||||||0.423
72508756|NCT02749721|144548166|OTHER||Pearson's R|-0.197||||0.406|TWO_SIDED||||||Pearson's correlation|||Correlation between VGNG P200 (amplitude) and HDRS-17 baseline scores||||0.406
72508757|NCT02749721|144548166|OTHER||Pearson's R|-0.309||||0.185|TWO_SIDED||||||Pearson's correlation|||Correlation between VGNG P3a (amplitude) and HDRS-17 baseline scores||||0.185
72508758|NCT02749721|144548166|OTHER||Pearson's R|-0.195||||0.454|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P200 (amplitude) and HDRS-17 baseline to endpoint percent change||||0.454
72566397|NCT02697773|144663267|SUPERIORITY||Odds Ratio (OR)|2.19||||0.0064|TWO_SIDED|95.0|1.25|3.85|||Regression, Logistic|||Week 12, \>=90%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.85|1.25|0.0064
72566398|NCT02697773|144663267|SUPERIORITY||Odds Ratio (OR)|1.58||||0.02|TWO_SIDED|95.0|1.07|2.31|||Regression, Logistic|||Week 16 \>=30%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.31|1.07|0.0200
72399731|NCT01412021|144307014|SUPERIORITY||||||<|0.0001|||||||paired t-test|||||||< 0.0001
72399732|NCT01412021|144307015|SUPERIORITY||||||<|0.0001|||||||paired t-test|||||||< 0.0001
72477492|NCT01160289|144480868|SUPERIORITY_OR_OTHER||LS mean of treatment difference|-0.12||||0.443||95.0||||Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed model repeated measures analysis|||||||0.443
72508759|NCT02749721|144548166|OTHER||Pearson's R|-0.162||||0.579|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P3a (amplitude) and HDRS-17 baseline to endpoint percent change||||0.579
72508760|NCT02749721|144548166|OTHER||Pearson's R|0.232||||0.549|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P3b (amplitude) and HDRS-17 baseline to endpoint percent change||||0.549
72508761|NCT02749721|144548166|OTHER||Pearson's R|0.169||||0.518|TWO_SIDED||||||Pearson's correlation|||Correlation between VGNG P200 (amplitude) and HDRS-17 baseline to endpoint percent change||||0.518
72508762|NCT02749721|144548166|OTHER||Pearson's R|0.027||||0.922|TWO_SIDED||||||Pearson's correlation|||Correlation between VGNG P3a (amplitude) and HDRS-17 baseline to endpoint percent change||||0.922
72508763|NCT02749721|144548166|OTHER||Pearson's R|-0.064||||0.796|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P200 (amplitude) and QIDS-SR baseline scores||||0.796
72508764|NCT02749721|144548166|OTHER||Pearson's R|-0.506||||0.054|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P3a (amplitude) and QIDS-SR baseline scores||||0.054
72508765|NCT02749721|144548166|OTHER||Pearson's R|0.002||||0.995|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P3b (amplitude) and QIDS-SR baseline scores||||0.995
72566399|NCT02697773|144663267|SUPERIORITY||Odds Ratio (OR)|2.12||||0.0002|TWO_SIDED|95.0|1.43|3.14|||Regression, Logistic|||Week 16 \>=30%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.14|1.43|0.0002
72399733|NCT01412021|144307016|SUPERIORITY||||||<|0.0001|||||||paired t-test|||||||< 0.0001
72399734|NCT01412021|144307017|SUPERIORITY||||||<|0.0001|||||||paired t-test|||||||< 0.0001
72399735|NCT01412021|144307018|SUPERIORITY||||||<|0.0001|||||||paired t-test|||||||< 0.0001
72399736|NCT01412021|144307019|SUPERIORITY||||||<|0.0001|||||||paired t-test|||||||< 0.0001
72399737|NCT01412021|144307020|SUPERIORITY||||||<|0.0001|||||||paired t-test|||||||< 0.0001
72399738|NCT01412021|144307021|SUPERIORITY||||||<|0.0001|||||||paired t-test|||||||< 0.0001
72399739|NCT01412021|144307022|SUPERIORITY||||||<|0.0001|||||||paired t-test|||||||< 0.0001
72477493|NCT01160289|144480868|SUPERIORITY_OR_OTHER||LS mean of treatment difference|-0.084||||0.599||95.0||||Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed model repeated measures analysis|||||||0.599
72477494|NCT01160289|144480868|SUPERIORITY_OR_OTHER||LS mean of treatment difference|-0.334||||0.029||95.0||||Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed model repeated measures analysis|||||||0.029
72508766|NCT02749721|144548166|OTHER||Pearson's R|0.102||||0.668|TWO_SIDED||||||Pearson's correlation|||Correlation between VGNG P200 (amplitude) and QIDS-SR baseline scores||||0.668
72508767|NCT02749721|144548166|OTHER||Pearson's R|0.037||||0.875|TWO_SIDED||||||Pearson's correlation|||Correlation between VGNG P3a (amplitude) and QIDS-SR baseline scores||||0.875
72508768|NCT02749721|144548166|OTHER||Pearson's R|-0.049||||0.852|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P200 (amplitude) and QIDS-SR baseline to endpoint percent change||||0.852
72508769|NCT02749721|144548166|OTHER||Pearson's R|-0.34||||0.234|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P3a (amplitude) and QIDS-SR baseline to endpoint percent change||||0.234
72508770|NCT02749721|144548166|OTHER||Pearson's R|0.655||||0.056|TWO_SIDED||||||Pearson's correlation|||||||0.056
72508771|NCT02749721|144548166|OTHER||Pearson's R|0.297||||0.248|TWO_SIDED||||||Pearson's correlation|||Correlation between VGNG P200 (amplitude) and QIDS-SR baseline to endpoint percent change||||0.248
72508772|NCT02749721|144548166|OTHER||Pearson's R|0.179||||0.507|TWO_SIDED||||||Pearson's correlation|||Correlation between VGNG P3a (amplitude) and QIDS-SR baseline to endpoint percent change||||0.507
72508773|NCT02749721|144548166|OTHER||Pearson's R|0.049||||0.841|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P200 (amplitude) and PDQ baseline scores||||0.841
72508774|NCT02749721|144548166|OTHER||Pearson's R|-0.185||||0.508|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P3a (amplitude) and PDQ baseline scores||||0.508
72508775|NCT02749721|144548166|OTHER||Pearson's R|-0.03||||0.916|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P3b (amplitude) and PDQ baseline scores||||0.916
72508776|NCT02749721|144548166|OTHER||Pearson's R|-0.345||||0.147|TWO_SIDED||||||Pearson's correlation|||Correlation between VGNG P200 (amplitude) and PDQ baseline scores||||0.147
72508777|NCT02749721|144548166|OTHER||Pearson's R|-0.284||||0.225|TWO_SIDED||||||Pearson's correlation|||Correlation between VGNG P3a (amplitude) and PDQ baseline scores||||0.225
72508778|NCT02749721|144548166|OTHER||Pearson's R|-0.044||||0.868|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P200 (amplitude) and PDQ baseline to endpoint percent change||||0.868
72508779|NCT02749721|144548166|OTHER||Pearson's R|-0.18||||0.537|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P3a (amplitude) and PDQ baseline to endpoint percent change||||0.537
72508780|NCT02749721|144548166|OTHER||Pearson's R|0.476||||0.195|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P3b (amplitude) and PDQ baseline to endpoint percent change||||0.195
72508781|NCT02749721|144548166|OTHER||Pearson's R|0.594||||0.015|TWO_SIDED||||||Pearson's correlation|||Correlation between VGNG P200 (amplitude) and PDQ baseline to endpoint percent change||||0.015
72477495|NCT01160289|144480869|SUPERIORITY_OR_OTHER||LS Mean of treatment difference|-0.152||||0.148||95.0||||The p-value is for the change from baseline to Week 12 in total cholesterol; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed model repeated measures analysis|||||||0.148
72477496|NCT01160289|144480869|SUPERIORITY_OR_OTHER||LS mean of treatment difference|-0.216||||0.033||95.0||||The p-value is for the change from baseline to Week 12 in total cholesterol; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed model repeated measures analysis|||||||0.033
72477497|NCT01160289|144480869|SUPERIORITY_OR_OTHER||LS mean of treatment difference|-0.124||||0.224||95.0||||The p-value is for the change from baseline to Week 12 in total cholesterol; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed model repeated measures analysis|||||||0.224
72477498|NCT01160289|144480869|SUPERIORITY_OR_OTHER||LS mean of treatment difference|-0.189||||0.056||95.0||||The p-value is for the change from baseline to Week 12 in total cholesterol; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed model repeated measures analysis|||||||0.056
72477499|NCT01160289|144480869|SUPERIORITY_OR_OTHER||LS mean of treatment difference|-0.211||||0.031||95.0||||The p-value is for the change from baseline to Week 12 in triglycerides; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed model repeated measures analysis|||||||0.031
72477500|NCT01160289|144480869|SUPERIORITY_OR_OTHER||LS mean of treatment difference|-0.227||||0.017||95.0||||The p-value is for the change from baseline to Week 12 in triglycerides; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed model repeated measures analysis|||||||0.017
72477501|NCT01160289|144480869|SUPERIORITY_OR_OTHER||LS mean of treatment difference|-0.016||||0.866||95.0||||The p-value is for the change from baseline to Week 12 in triglycerides; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed model repeated measures analysis|||||||0.866
72477502|NCT01160289|144480869|SUPERIORITY_OR_OTHER||LS mean of treatment difference|-0.032||||0.726||95.0||||The p-value is for the change from baseline to Week 12 in triglycerides; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed model repeated measures analysis|||||||0.726
72477503|NCT01160289|144480870|SUPERIORITY_OR_OTHER||LS Mean of treatment difference|-9.014|||<|0.001||95.0||||The p-value is for the percent change from baseline to Week 12 in HDL-C; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed model repeated measures analysis|||||||<0.001
72508782|NCT02749721|144548166|OTHER||Pearson's R|-0.009||||0.972|TWO_SIDED||||||Pearson's correlation|||Correlation between VGNG P3a (amplitude) and PDQ baseline to endpoint percent change||||0.972
72508783|NCT02749721|144548166|OTHER||Pearson's R|0.067||||0.785|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P200 (amplitude) and MGH-CPFQ baseline scores||||0.785
72508784|NCT02749721|144548166|OTHER||Pearson's R|-0.129||||0.646|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P3a (amplitude) and MGH-CPFQ baseline scores||||0.646
72623350|NCT04562090|144777422|SUPERIORITY|Statistical testing was conducted using 2-sided at a significance level of 0.05.|LS Mean|-1.2|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|95.0|-1.34|-1.05||RMA: CFB as response, treatment group, visit (week 4, 8 and 12), pooled site, sex and the interaction between treatment group and visit as fixed effects and mean number of urge incontinence episodes per 24 hours at baseline as covariate.|MMRM|||Week 8||-1.05|-1.34|<0.001
72477504|NCT01160289|144480870|SUPERIORITY_OR_OTHER||LS mean of treatment difference|-18.547|||<|0.001||95.0||||The p-value is for the percent change from baseline to Week 12 in HDL-C; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed model repeated measures analysis|||||||<0.001
72508785|NCT02749721|144548166|OTHER||Pearson's R|0.364||||0.182|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P3b (amplitude) and MGH-CPFQ baseline scores||||0.182
72477505|NCT01160289|144480870|SUPERIORITY_OR_OTHER||LS mean of treatment difference|-9.216|||<|0.001||95.0||||The p-value is for the percent change from baseline to Week 12 in HDL-C; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed model repeated measures analysis|||||||<0.001
72477506|NCT01160289|144480870|SUPERIORITY_OR_OTHER||LS mean of treatment difference|-18.75|||<|0.001||95.0||||The p-value is for the percent change from baseline to Week 12 in HDL-C; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed model repeated measures analysis|||||||<0.001
72477507|NCT01160289|144480870|SUPERIORITY_OR_OTHER||LS mean of treatment difference|-0.977||||0.776||95.0||||The p-value is for the percent change from baseline to Week 12 in LDL-C; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed model repeated measures analysis|||||||0.776
72477508|NCT01160289|144480870|SUPERIORITY_OR_OTHER||LS mean of treatment difference|0.78||||0.814||95.0||||The p-value is for the percent change from baseline to Week 12 in LDL-C; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed model repeated measures analysis|||||||0.814
72477509|NCT01160289|144480870|SUPERIORITY_OR_OTHER||LS mean of treatment difference|-1.629||||0.627||95.0||||The p-value is for the percent change from baseline to Week 12 in LDL-C; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed model repeated measures analysis|||||||0.627
72477510|NCT01160289|144480870|SUPERIORITY_OR_OTHER||LS mean of treatment difference|0.128||||0.968||95.0||||The p-value is for the percent change from baseline to Week 12 in LDL-C; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed model repeated measures analysis|||||||0.968
72477511|NCT01160289|144480871|SUPERIORITY_OR_OTHER||LS Mean of treatment difference|-0.006||||0.984||95.0||||Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed model repeated measures analysis|||||||0.984
72477512|NCT01160289|144480871|SUPERIORITY_OR_OTHER||LS mean of treatment difference|-0.465||||0.076||95.0||||Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed model repeated measures analysis|||||||0.076
72477513|NCT01160289|144480871|SUPERIORITY_OR_OTHER||LS mean of treatment difference|0.387||||0.142||95.0||||Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed model repeated measures analysis|||||||0.142
72477514|NCT01160289|144480871|SUPERIORITY_OR_OTHER||LS mean of treatment difference|-0.072||||0.776||95.0||||Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed model repeated measures analysis|||||||0.776
72508786|NCT02749721|144548166|OTHER||Pearson's R|-0.414||||0.069|TWO_SIDED||||||Pearson's correlation|||Correlation between VGNG P200 (amplitude) and MGH-CPFQ baseline scores||||0.069
72477515|NCT01160289|144480872|SUPERIORITY_OR_OTHER||LS Mean of treatment difference|5.031||||0.103||95.0||||Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed model repeated measures analysis|||||||0.103
72477516|NCT01160289|144480872|SUPERIORITY_OR_OTHER||LS mean treatment difference|-3.225||||0.277||95.0||||Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed model repeated measures analysis|||||||0.277
72477517|NCT01160289|144480872|SUPERIORITY_OR_OTHER||LS mean of treatment difference|7.056||||0.019||95.0||||Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed model repeated measures analysis|||||||0.019
72477518|NCT01160289|144480872|SUPERIORITY_OR_OTHER||LS mean of treatment difference|-1.201||||0.676||95.0||||Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed model repeated measures analysis|||||||0.676
72477519|NCT01156792|144480890|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.026|||=|0.268|TWO_SIDED|95.0|-0.02|0.07|||Mixed Models Analysis|||||0.07|-0.02|=0.268
72477520|NCT01156792|144480890|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.042|||=|0.08|TWO_SIDED|95.0|0.0|0.09|||Mixed Models Analysis|||||0.09|-0.00|=0.080
72477521|NCT01156792|144480890|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.056|||=|0.017|TWO_SIDED|95.0|0.01|0.1|||Mixed Models Analysis|||||0.10|0.01|=0.017
72477522|NCT01156792|144480890|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.074|||=|0.002|TWO_SIDED|95.0|0.03|0.12|||Mixed Models Analysis|||||0.12|0.03|=0.002
72477523|NCT01156792|144480891|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.946|||=|0.751|TWO_SIDED|95.0|-4.91|6.81|||Mixed Models Analysis|||||6.81|-4.91|=0.751
72477524|NCT01156792|144480891|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.771|||=|0.049|TWO_SIDED|95.0|0.03|11.51|||Mixed Models Analysis|||||11.51|0.03|=0.049
72477525|NCT01156792|144480891|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.983|||=|0.123|TWO_SIDED|95.0|-1.35|11.32|||Mixed Models Analysis|||||11.32|-1.35|=0.123
72508787|NCT02749721|144548166|OTHER||Pearson's R|-0.416||||0.068|TWO_SIDED||||||Pearson's correlation|||Correlation between VGNG P3a (amplitude) and MGH-CPFQ baseline scores||||0.068
72508788|NCT02749721|144548166|OTHER||Pearson's R|-0.023||||0.929|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P200 (amplitude) and MGH-CPFQ baseline to endpoint percent change||||0.929
72508789|NCT02749721|144548166|OTHER||Pearson's R|-0.074||||0.802|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P3a (amplitude) and MGH-CPFQ baseline to endpoint percent change||||0.802
72508790|NCT02749721|144548166|OTHER||Pearson's R|0.518||||0.153|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P3b (amplitude) and MGH-CPFQ baseline to endpoint percent change||||0.153
72508791|NCT02749721|144548166|OTHER||Pearson's R|0.268||||0.298|TWO_SIDED||||||Pearson's correlation|||Correlation between VGNG P200 (amplitude) and MGH-CPFQ baseline to endpoint percent change||||0.298
72477526|NCT01156792|144480891|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.14|||<|0.001|TWO_SIDED|95.0|5.93|18.35|||Mixed Models Analysis|||||18.35|5.93|<0.001
72477527|NCT01156792|144480892|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.651|||=|0.563|TWO_SIDED|95.0|-3.97|7.27|||Mixed Models Analysis|||||7.27|-3.97|=0.563
72477528|NCT01156792|144480892|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.1|||=|0.072|TWO_SIDED|95.0|-0.47|10.67|||Mixed Models Analysis|||||10.67|-0.47|=0.072
72477529|NCT01156792|144480892|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.822|||=|0.126|TWO_SIDED|95.0|-1.37|11.02|||Mixed Models Analysis|||||11.02|-1.37|=0.126
72477530|NCT01156792|144480892|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.292|||=|0.001|TWO_SIDED|95.0|4.21|16.38|||Mixed Models Analysis|||||16.38|4.21|=0.001
72477531|NCT01156792|144480893|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.154|||||TWO_SIDED|95.0|-9.36|1.06||||||||1.06|-9.36|
72477532|NCT01156792|144480893|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.364|||||TWO_SIDED|95.0|-6.22|5.5||||||||5.50|-6.22|
72477533|NCT01156792|144480894|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.005|||=|0.957|TWO_SIDED|95.0|-0.18|0.17|||Mixed Models Analysis|||||0.17|-0.18|=0.957
72477534|NCT01156792|144480894|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.108|||=|0.213|TWO_SIDED|95.0|-0.28|0.06|||Mixed Models Analysis|||||0.06|-0.28|=0.213
72477535|NCT01156792|144480894|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.038|||=|0.647|TWO_SIDED|95.0|-0.2|0.12|||Mixed Models Analysis|||||0.12|-0.20|=0.647
72477536|NCT01156792|144480894|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.011|||=|0.894|TWO_SIDED|95.0|-0.17|0.15|||Mixed Models Analysis|||||0.15|-0.17|=0.894
72477537|NCT01156792|144480895|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.025|||=|0.811|TWO_SIDED|95.0|-0.23|0.18|||Mixed Models Analysis|||||0.18|-0.23|=0.811
72477538|NCT01156792|144480895|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.133|||=|0.2|TWO_SIDED|95.0|-0.34|0.07|||Mixed Models Analysis|||||0.07|-0.34|=0.200
72477539|NCT01156792|144480895|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.076|||=|0.415|TWO_SIDED|95.0|-0.26|0.11|||Mixed Models Analysis|||||0.11|-0.26|=0.415
72477540|NCT01156792|144480895|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.084|||=|0.358|TWO_SIDED|95.0|-0.26|0.1|||Mixed Models Analysis|||||0.10|-0.26|=0.358
72477541|NCT01156792|144480896|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.666|||=|0.285|TWO_SIDED|95.0|-2.24|7.57|||Mixed Models Analysis|||||7.57|-2.24|=0.285
72477542|NCT01156792|144480896|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.3|||=|0.035|TWO_SIDED|95.0|0.38|10.22|||Mixed Models Analysis|||||10.22|0.38|=0.035
72477543|NCT01156792|144480896|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.036|||=|0.09|TWO_SIDED|95.0|-0.63|8.7|||Mixed Models Analysis|||||8.70|-0.63|=0.090
72477544|NCT01156792|144480896|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.602|||=|0.047|TWO_SIDED|95.0|0.06|9.14|||Mixed Models Analysis|||||9.14|0.06|=0.047
72477545|NCT01156792|144480897|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.014|||=|0.668|TWO_SIDED|95.0|-3.64|5.67|||Mixed Models Analysis|||||5.67|-3.64|=0.668
72477546|NCT01156792|144480897|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.349|||=|0.156|TWO_SIDED|95.0|-1.29|7.98|||Mixed Models Analysis|||||7.98|-1.29|=0.156
72477547|NCT01156792|144480897|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.496|||=|0.822|TWO_SIDED|95.0|-3.83|4.82|||Mixed Models Analysis|||||4.82|-3.83|=0.822
72477548|NCT01156792|144480897|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.26|||=|0.555|TWO_SIDED|95.0|-2.94|5.46|||Mixed Models Analysis|||||5.46|-2.94|=0.555
72399740|NCT03658538|144307079|SUPERIORITY||Mean Difference (Final Values)|-4.4||||0.025|TWO_SIDED|95.0|-8.2|-0.5||P-value corresponds to the statistical significance of the group difference (active vs. control) in the primary outcome, and was not adjusted for the multiple comparison and based on the a priori threshold for statistical significance (P\<0.05).|Generalized Linear Mixed Model (GLMM)|The analysis was adjusted for covariates.||||-0.5|-8.2|0.025
72399741|NCT03658538|144307080|SUPERIORITY|||||||0.061||||||P-value corresponds to the statistical significance of the group difference (active vs. control) in the primary outcome, and was not adjusted for the multiple comparison and based on the a priori threshold for statistical significance (P\<0.05).|Generalized Linear Mixed Model (GLMM)|The analysis was adjusted for covariates.||||||0.061
72399742|NCT02446990|144307089|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|1.08|STANDARD_ERROR_OF_MEAN|0.06||0.1969|TWO_SIDED|95.0|0.96|1.2|||Regression, Cox|||||1.2|0.96|0.1969
72623351|NCT04562090|144777422|SUPERIORITY|Statistical testing was conducted using 2-sided at a significance level of 0.05.|LS Mean|-1.25|STANDARD_ERROR_OF_MEAN|0.15|<|0.001|TWO_SIDED|95.0|-1.54|-0.96||RMA: CFB as response, treatment group, visit (week 4, 8 and 12), pooled site, sex and the interaction between treatment group and visit as fixed effects and mean number of urge incontinence episodes per 24 hours at baseline as covariate.|MMRM|||Week 12||-0.96|-1.54|<0.001
72399743|NCT02446990|144307090|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|1.06|STANDARD_ERROR_OF_MEAN|0.07||0.3461|TWO_SIDED|95.0|0.94|1.21|||Regression, Cox|||||1.21|0.94|0.3461
72399744|NCT02446990|144307091|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|1.1|STANDARD_ERROR_OF_MEAN|0.09||0.2493|TWO_SIDED|95.0|0.94|1.28|||Regression, Cox|||||1.28|0.94|0.2493
72399745|NCT02446990|144307092|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|1.06|STANDARD_ERROR_OF_MEAN|0.09||0.5162|TWO_SIDED|95.0|0.89|1.26|||Regression, Cox|||||1.26|0.89|0.5162
72508792|NCT02749721|144548166|OTHER||Pearson's R|-0.001||||0.996|TWO_SIDED||||||Pearson's correlation|||Correlation between VGNG P3a (amplitude) and MGH-CPFQ baseline to endpoint percent change||||0.996
72508793|NCT02749721|144548166|OTHER||Pearson's R|0.242||||0.531|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P200 (amplitude) and WLQ baseline scores||||0.531
72508794|NCT02749721|144548166|OTHER||Pearson's R|-0.598||||0.21|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P3a (amplitude) and WLQ baseline scores||||0.210
72508795|NCT02749721|144548166|OTHER||Pearson's R|0.054||||0.899|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P3b (amplitude) and WLQ baseline scores||||0.899
72508796|NCT02749721|144548166|OTHER||Pearson's R|0.568||||0.087|TWO_SIDED||||||Pearson's correlation|||||||0.087
72508797|NCT02749721|144548166|OTHER||Pearson's R|0.568||||0.087|TWO_SIDED||||||Pearson's correlation|||Correlation between VGNG P3a (amplitude) and WLQ baseline scores||||0.087
72508798|NCT02749721|144548166|OTHER||Pearson's R|0.231||||0.55|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P200 (amplitude) and WLQ baseline to endpoint percent change||||0.550
72508799|NCT02749721|144548166|OTHER||Pearson's R|0.158||||0.766|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P3a (amplitude) and WLQ baseline to endpoint percent change||||0.766
72508800|NCT02749721|144548166|OTHER||Pearson's R|-0.406||||0.498|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P3b (amplitude) and WLQ baseline to endpoint percent change||||0.498
72508801|NCT02749721|144548166|OTHER||Pearson's R|0.221||||0.599|TWO_SIDED||||||Pearson's correlation|||Correlation between VGNG P200 (amplitude) and WLQ baseline to endpoint percent change||||0.599
72508802|NCT02749721|144548166|OTHER||Pearson's R|0.679||||0.064|TWO_SIDED||||||Pearson's correlation|||Correlation between VGNG P3a (amplitude) and WLQ baseline to endpoint percent change||||0.064
72508803|NCT02749721|144548167|OTHER||Pearson's R|-0.038||||0.881|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P200 (latency) and HDRS-28 baseline scores||||0.881
72508804|NCT02749721|144548167|OTHER||Pearson's R|0.299||||0.279|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P3a (latency) and HDRS-28 baseline scores||||0.279
72508805|NCT02749721|144548167|OTHER||Pearson's R|0.538||||0.039|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P3b (latency) and HDRS-28 baseline scores||||0.039
72508806|NCT02749721|144548167|OTHER||Pearson's R|-0.018||||0.94|TWO_SIDED||||||Pearson's correlation|||Correlation between VGNG P200 (latency) and HDRS-28 baseline scores||||0.940
72508807|NCT02749721|144548167|OTHER||Pearson's R|0.107||||0.65|TWO_SIDED||||||Pearson's correlation|||Correlation between VGNG P3a (latency) and HDRS-28 baseline scores||||0.65
72508808|NCT02749721|144548167|OTHER||Pearson's R|0.247||||0.34|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P200 (latency) and HDRS-28 baseline to endpoint percentage change||||0.340
72508809|NCT02749721|144548167|OTHER||Pearson's R|0.067||||0.819|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P3a (latency) and HDRS-28 baseline to endpoint percentage change||||0.819
72508810|NCT02749721|144548167|OTHER||Pearson's R|0.321||||0.4|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P3b (latency) and HDRS-28 baseline to endpoint percentage change||||0.400
72508811|NCT02749721|144548167|OTHER||Pearson's R|0.279||||0.278|TWO_SIDED||||||Pearson's correlation|||Correlation between VGNG P200 (latency) and HDRS-28 baseline to endpoint percentage change||||0.278
72508812|NCT02749721|144548167|OTHER||Pearson's R|-0.136||||0.614|TWO_SIDED||||||Pearson's correlation|||Correlation between VGNG P3a (latency) and HDRS-28 baseline to endpoint percentage change||||0.614
72508813|NCT02749721|144548167|OTHER||Pearson's R|0.0||||0.999|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P200 (latency) and HDRS-17 baseline scores||||0.999
72508814|NCT02749721|144548167|OTHER||Pearson's R|0.193||||0.491|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P3a (latency) and HDRS-17 baseline scores||||0.491
72508815|NCT02749721|144548167|OTHER||Pearson's R|0.567||||0.028|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P3b (latency) and HDRS-17 baseline scores||||0.028
72399746|NCT02446990|144307093|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|1.35|STANDARD_ERROR_OF_MEAN|0.29||0.1647|TWO_SIDED|95.0|0.88|2.05|||Regression, Cox|||||2.05|0.88|0.1647
72399747|NCT02446990|144307094|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|1.04|STANDARD_ERROR_OF_MEAN|0.08||0.6024|TWO_SIDED|95.0|0.9|1.21|||Regression, Cox|||||1.21|0.90|0.6024
72399748|NCT02446990|144307095|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|0.89||||0.1458|TWO_SIDED|95.0|0.75|1.04|||Regression, Cox|||||1.04|0.75|0.1458
72399749|NCT02446990|144307096|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|1.0||||0.979|TWO_SIDED|95.0|0.89|1.12|||Regression, Cox|||||1.12|0.89|0.9790
72477549|NCT01156792|144480898|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.992|||=|0.367|TWO_SIDED|95.0|-2.35|6.33|||Mixed Models Analysis|||||6.33|-2.35|=0.367
72477550|NCT01156792|144480898|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.147|||=|0.332|TWO_SIDED|95.0|-2.2|6.49|||Mixed Models Analysis|||||6.49|-2.20|=0.332
72477551|NCT01156792|144480898|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.331|||=|0.277|TWO_SIDED|95.0|-1.88|6.55|||Mixed Models Analysis|||||6.55|-1.88|=0.277
72477552|NCT01156792|144480898|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.521|||=|0.467|TWO_SIDED|95.0|-2.59|5.63|||Mixed Models Analysis|||||5.63|-2.59|=0.467
72477553|NCT01156792|144480899|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.575|||=|0.789|TWO_SIDED|95.0|-3.65|4.8|||Mixed Models Analysis|||||4.80|-3.65|=0.789
72477554|NCT01156792|144480899|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.669|||=|0.087|TWO_SIDED|95.0|-0.54|7.87|||Mixed Models Analysis|||||7.87|-0.54|=0.087
72477555|NCT01156792|144480899|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2|||=|0.923|TWO_SIDED|95.0|-3.84|4.24|||Mixed Models Analysis|||||4.24|-3.84|=0.923
72477556|NCT01156792|144480899|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.137|||=|0.571|TWO_SIDED|95.0|-5.08|2.81|||Mixed Models Analysis|||||2.81|-5.08|=0.571
72477557|NCT01156792|144480900|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.014|||=|0.668|TWO_SIDED|95.0|-3.64|5.67|||Mixed Models Analysis|||||5.67|-3.64|=0.668
72477558|NCT01156792|144480900|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.349|||=|0.156|TWO_SIDED|95.0|-1.29|7.98|||Mixed Models Analysis|||||7.98|-1.29|=0.156
72508816|NCT02749721|144548167|OTHER||Pearson's R|-0.03||||0.9|TWO_SIDED||||||Pearson's correlation|||Correlation between VGNG P200 (latency) and HDRS-17 baseline scores||||0.900
72508817|NCT02749721|144548167|OTHER||Pearson's R|0.141||||0.55|TWO_SIDED||||||Pearson's correlation|||Correlation between VGNG P3a (latency) and HDRS-17 baseline scores||||0.55
72399750|NCT02446990|144307097|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|1.06||||0.4299|TWO_SIDED|95.0|0.92|1.22|||Regression, Cox|||||1.22|0.92|0.4299
72399751|NCT02446990|144307098|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|0.97||||0.5916|TWO_SIDED|95.0|0.88|1.08|||Regression, Cox|||||1.08|0.88|0.5916
72399752|NCT02446990|144307099|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|0.98||||0.6963|TWO_SIDED|95.0|0.89|1.08|||Regression, Cox|||||1.08|0.89|0.6963
72399753|NCT02446990|144307100|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|1.06||||0.2222|TWO_SIDED|95.0|0.96|1.18|||Regression, Cox|||||1.18|0.96|0.2222
72399754|NCT02446990|144307101|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|1.05||||0.3671|TWO_SIDED|95.0|0.94|1.18|||Regression, Cox|||||1.18|0.94|0.3671
72477559|NCT01156792|144480900|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.496|||=|0.822|TWO_SIDED|95.0|-3.83|4.82|||Mixed Models Analysis|||||4.82|-3.83|=0.822
72477560|NCT01156792|144480900|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.26|||=|0.555|TWO_SIDED|95.0|-2.94|5.46|||Mixed Models Analysis|||||5.46|-2.94|=0.555
72477561|NCT01156792|144480901|SUPERIORITY_OR_OTHER||||||=|0.408||95.0|||||Fisher Exact|||||||=0.408
72477562|NCT01156792|144480901|SUPERIORITY_OR_OTHER||||||=|0.138||95.0|||||Fisher Exact|||||||=0.138
72477563|NCT01156792|144480901|SUPERIORITY_OR_OTHER||||||=|0.797||95.0|||||Fisher Exact|||||||=0.797
72477564|NCT01156792|144480901|SUPERIORITY_OR_OTHER||||||=|0.408||95.0|||||Fisher Exact|||||||=0.408
72477565|NCT00952120|144480943|SUPERIORITY_OR_OTHER|||||||0.8|TWO_SIDED||||||Regression, Logistic|robust standard errors were used to account for the multiple observations per patient||||||0.80
72477566|NCT03618823|144480950|EQUIVALENCE|All pain scores were included due to the sample size. Alpha =.05 Power = .80 Desired effect size of 0.30 Size of n=145 in each group was determined, however this was not reached for sufficient power.||||||0.912|||||||Mixed Models Analysis|Two-way mixed-model analysis of variance||There will be no difference in pain scores between opioid and non-opioid groups from before medication to after while controlling for total duration of mediation use (duration mean=10.11 days).||||.912
72477567|NCT03618823|144480951|SUPERIORITY||Odds Ratio (OR)|1.311||||0.63|TWO_SIDED|95.0|0.494|3.478|||Fisher Exact|||There will be no difference in ED (Emergency Department) or urgent care visits between opioid and non-opioid pain control groups.||3.478|.494|.630
72477568|NCT00523640|144480964|SUPERIORITY_OR_OTHER||Proportion responding|0.24|||||TWO_SIDED|95.0|0.1|0.44||||||||0.44|0.10|
72477569|NCT01506609|144480971|SUPERIORITY||Hazard Ratio (HR)|0.789||||0.227|TWO_SIDED|95.0|0.536|1.162|||Log Rank|||||1.162|0.536|0.227
72477570|NCT01506609|144480971|SUPERIORITY||Hazard Ratio (HR)|1.858||||0.001|TWO_SIDED|95.0|1.278|2.702|||Log Rank|||||2.702|1.278|0.001
72477571|NCT01506609|144480972|SUPERIORITY||Hazard Ratio (HR)|0.848||||0.368|TWO_SIDED|95.0|0.59|1.218|||Log Rank|||||1.218|0.590|0.368
72477572|NCT01506609|144480972|SUPERIORITY||Hazard Ratio (HR)|1.512||||0.017|TWO_SIDED|95.0|1.074|2.127|||Log Rank|||||2.127|1.074|0.017
72477573|NCT01506609|144480973|SUPERIORITY|||||||0.434||||||P-value is from Cochran-Mantel-Haenszel test stratified by estrogen receptor/progesterone receptor status and prior cytotoxic therapy use.|Cochran-Mantel-Haenszel|||||||0.434
72477574|NCT01506609|144480973|SUPERIORITY|||||||0.019||||||P-value is from Cochran-Mantel-Haenszel test stratified by estrogen receptor/progesterone receptor status and prior cytotoxic therapy use.|Cochran-Mantel-Haenszel|||||||0.019
72477575|NCT01506609|144480974|SUPERIORITY|||||||0.027||||||P-value is from Cochran-Mantel-Haenszel test stratified by estrogen receptor/progesterone receptor status and prior cytotoxic therapy use.|Cochran-Mantel-Haenszel|||||||0.027
72477576|NCT01506609|144480974|SUPERIORITY||||||<|0.001||||||P-value is from Cochran-Mantel-Haenszel test stratified by estrogen receptor/progesterone receptor status and prior cytotoxic therapy use.|Cochran-Mantel-Haenszel|||||||< 0.001
72477577|NCT01506609|144480975|SUPERIORITY||Least Squares (LS) Mean of Difference|-2.302|STANDARD_ERROR_OF_MEAN|2.476||0.354|TWO_SIDED|95.0|-7.2|2.6||ANCOVA with treatment arm and baseline value as covariate.|ANCOVA|||||2.60|-7.20|0.354
72623352|NCT04562090|144777422|SUPERIORITY|Statistical testing was conducted using 2-sided at a significance level of 0.05.|LS Mean|-1.27|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-1.42|-1.12||RMA: CFB as response, treatment group, visit (week 4, 8 and 12), pooled site, sex and the interaction between treatment group and visit as fixed effects and mean number of urge incontinence episodes per 24 hours at baseline as covariate.|MMRM|||Week 12||-1.12|-1.42|<0.001
72623353|NCT04562090|144777423|SUPERIORITY|Statistical testing was conducted using 2-sided at a significance level of 0.05.|LS Mean|-2.97|STANDARD_ERROR_OF_MEAN|0.27|<|0.001|TWO_SIDED|95.0|-3.5|-2.43||RMA: CFB as response, TG, visit (week 4, 8 and 12), pooled site, sex and the interaction between TG and visit as fixed effects and mean number of OABSS at baseline as covariate.|MMRM|||Week 4||-2.43|-3.50|<0.001
72623354|NCT04562090|144777423|SUPERIORITY|Statistical testing was conducted using 2-sided at a significance level of 0.05.|LS Mean|-3.05|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|-3.44|-2.65||RMA: CFB as response, TG, visit (week 4, 8 and 12), pooled site, sex and the interaction between TG and visit as fixed effects and mean number of OABSS at baseline as covariate.|MMRM|||Week 4||-2.65|-3.44|<0.001
72623355|NCT04562090|144777423|SUPERIORITY|Statistical testing was conducted using 2-sided at a significance level of 0.05.|LS Mean|-5.09|STANDARD_ERROR_OF_MEAN|0.36|<|0.001|TWO_SIDED|95.0|-5.8|-4.39||RMA: CFB as response, TG, visit (week 4, 8 and 12), pooled site, sex and the interaction between TG and visit as fixed effects and mean number of OABSS at baseline as covariate.|MMRM|||Week 8||-4.39|-5.80|<0.001
72623356|NCT04562090|144777423|SUPERIORITY|Statistical testing was conducted using 2-sided at a significance level of 0.05.|LS Mean|-4.3|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|-4.7|-3.9||RMA: CFB as response, TG, visit (week 4, 8 and 12), pooled site, sex and the interaction between TG and visit as fixed effects and mean number of OABSS at baseline as covariate.|MMRM|||Week 8||-3.90|-4.70|<0.001
72623357|NCT04562090|144777423|SUPERIORITY|Statistical testing was conducted using 2-sided at a significance level of 0.05.|LS Mean|-6.01|STANDARD_ERROR_OF_MEAN|0.39|<|0.001|TWO_SIDED|95.0|-6.78|-5.24||RMA: CFB as response, TG, visit (week 4, 8 and 12), pooled site, sex and the interaction between TG and visit as fixed effects and mean number of OABSS at baseline as covariate.|MMRM|||Week 12||-5.24|-6.78|<0.001
72399755|NCT02446990|144307102|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|0.97||||0.5285|TWO_SIDED|95.0|0.87|1.07|||Regression, Cox|||||1.07|0.87|0.5285
72477578|NCT00116753|144480987|SUPERIORITY_OR_OTHER||Percentage of partcipants|78.3|||||TWO_SIDED|96.5|69.0|86.0|||||Estimated value is the percentage of participants with all testosterone values from Day 28 to end of study \<=0.5 ng/mL. Measure dispersion is the 96.5% two-sided confidence interval which was calculated by the Clopper-Pearson method.|||86|69|
72477579|NCT00116753|144480987|SUPERIORITY_OR_OTHER||Percentage of participants|79.5|||||TWO_SIDED|96.5|71.0|87.0|||||Estimated value is the percentage of participants with all testosterone values from Day 28 to end of study \<=0.5 ng/mL. Measure dispersion is the 96.5% two-sided confidence interval which was calculated by the Clopper-Pearson method.|||87|71|
72477580|NCT00116753|144480987|SUPERIORITY_OR_OTHER||Percentage of participants|85.3|||||TWO_SIDED|96.5|77.0|91.0|||||Estimated value is the percentage of participants with all testosterone values from Day 28 to end of study \<=0.5 ng/mL. Measure dispersion is the 96.5% two-sided confidence interval which was calculated by the Clopper-Pearson method.|||91|77|
72477581|NCT00116753|144480987|SUPERIORITY_OR_OTHER|||||||0.3022||95.0|||||Mantel Haenszel|||||||0.3022
72623358|NCT04562090|144777423|SUPERIORITY|Statistical testing was conducted using 2-sided at a significance level of 0.05.|LS Mean|-5.4|STANDARD_ERROR_OF_MEAN|0.21|<|0.001|TWO_SIDED|95.0|-5.82|-4.98||RMA: CFB as response, TG, visit (week 4, 8 and 12), pooled site, sex and the interaction between TG and visit as fixed effects and mean number of OABSS at baseline as covariate.|MMRM|||Week 12||-4.98|-5.82|<0.001
72477582|NCT00116753|144480987|SUPERIORITY_OR_OTHER|||||||0.7797||95.0|||||Mantel Haenszel|||||||0.7797
72623359|NCT04562090|144777424|SUPERIORITY|Statistical testing was conducted using 2-sided at a significance level of 0.05.|LS Mean|-1.97|STANDARD_ERROR_OF_MEAN|0.38|<|0.001|TWO_SIDED|95.0|-2.73|-1.21||RMA: CFB as response, TG, visit (week 4, 8), pooled site, sex and the interaction between TG and visit as fixed effects and mean number of micturitions per 24 hours at baseline as covariate.|MMRM|||Week 4||-1.21|-2.73|<0.001
72623360|NCT04562090|144777424|SUPERIORITY|Statistical testing was conducted using 2-sided at a significance level of 0.05.|LS Mean|-2.36|STANDARD_ERROR_OF_MEAN|0.28|<|0.001|TWO_SIDED|95.0|-2.9|-1.81||RMA: CFB as response, TG, visit (week 4, 8), pooled site, sex and the interaction between TG and visit as fixed effects and mean number of micturitions per 24 hours at baseline as covariate.|MMRM|||Week 4||-1.81|-2.90|<0.001
72399756|NCT02921776|144307105|SUPERIORITY||Mean Difference (Final Values)|0.18||||0.45|TWO_SIDED||||||t-test, 2 sided|||||||0.45
72399757|NCT02921776|144307106|SUPERIORITY||Mean Difference (Final Values)|0.48||||0.55|TWO_SIDED||||||t-test, 2 sided|||||||0.55
72399758|NCT02921776|144307107|OTHER|||||||0.1|||||||Effect size|Effect size =-0.29||||||0.10
72399759|NCT02921776|144307107|SUPERIORITY||Mean Difference (Final Values)|0.39||||0.1|TWO_SIDED||||||t-test, 2 sided|||||||.10
72477583|NCT00116753|144480987|SUPERIORITY_OR_OTHER|||||||0.1557||95.0|||||Mantel Haenszel|||||||0.1557
72477584|NCT00116753|144480987|SUPERIORITY_OR_OTHER|||||||0.2208||95.0|||||Mantel Haenszel|||||||0.2208
72477585|NCT00116753|144480988|SUPERIORITY_OR_OTHER||Percentage of participants|80.7|||||TWO_SIDED|96.5|72.0|88.0|||||Estimated value is the percentage of participants with all testosterone values from after Day 28 to end of study \<=0.5 ng/mL. Measure dispersion is the 96.5% two-sided confidence interval which was calculated by the Clopper-Pearson method.|||88|72|
72477586|NCT00116753|144480988|SUPERIORITY_OR_OTHER||Percentage of participants|80.2|||||TWO_SIDED|96.5|72.0|87.0|||||Estimated value is the percentage of participants with all testosterone values from Day 28 to end of study \<=0.5 ng/mL. Measure dispersion is the 96.5% two-sided confidence interval which was calculated by the Clopper-Pearson method.|||87|72|
72477587|NCT00116753|144480988|SUPERIORITY_OR_OTHER||Percentage of participants|86.0|||||TWO_SIDED|96.5|78.0|92.0|||||Estimated value is the percentage of participants with all testosterone values from Day 28 to end of study \<=0.5 ng/mL. Measure dispersion is the 96.5% two-sided confidence interval which was calculated by the Clopper-Pearson method.|||92|78|
72477588|NCT00116753|144480988|SUPERIORITY_OR_OTHER|||||||0.383||95.0|||||Mantel Haenszel|||||||0.3830
72477589|NCT00116753|144480988|SUPERIORITY_OR_OTHER|||||||0.9587||95.0|||||Mantel Haenszel|||||||0.9587
72477590|NCT00116753|144480988|SUPERIORITY_OR_OTHER|||||||0.2579||95.0|||||Mantel Haenszel|||||||0.2579
72399760|NCT02921776|144307108|SUPERIORITY|||||||0.02|||||||Mixed Models Analysis|||Benzodiazepine exposure||||0.02
72477591|NCT00116753|144480988|SUPERIORITY_OR_OTHER|||||||0.2072||95.0|||||Mantel Haenszel|||||||0.2072
72477592|NCT00116753|144480989|SUPERIORITY_OR_OTHER||Percentage of participants|97.3|||||TWO_SIDED|95.0|93.0|99.0|||||Estimated value is the percentage of participants with testosterone \<=0.5 ng/mL at Day 28. Measure dispersion is the 95% two-sided confidence interval which was calculated by the Clopper-Pearson method.|||99|93|
72477593|NCT00116753|144480989|SUPERIORITY_OR_OTHER||Percentage of participants|97.9|||||TWO_SIDED|95.0|94.0|100.0|||||Estimated value is the percentage of participants with testosterone \<=0.5 ng/mL at Day 28. Measure dispersion is the 95% two-sided confidence interval which was calculated by the Clopper-Pearson method.|||100|94|
72477594|NCT00116753|144480989|SUPERIORITY_OR_OTHER||Percentage of participants|97.9|||||TWO_SIDED|95.0|94.0|100.0|||||Estimated value is the percentage of participants with testosterone \<=0.5 ng/mL at Day 28. Measure dispersion is the 95% two-sided confidence interval which was calculated by the Clopper-Pearson method.|||100|94|
72477595|NCT01642251|144480993|SUPERIORITY||Hazard Ratio (HR)|0.34|||<|0.001|TWO_SIDED|80.0|0.22|0.51||one-sided p value|Regression, Cox|adjusted for ECOG performance status, abnormal protein in the Cox proportional hazard model||The significance test reported here was for treatment arms comparison in patients within the male/abnormal LDH stratum||0.51|0.22|<0.001
72477596|NCT01642251|144480993|SUPERIORITY||Hazard Ratio (HR)|0.81||||0.18|TWO_SIDED|80.0|0.6|1.09||one-sided p value|Regression, Cox|adjusted for ECOG performance status, abnormal protein in the Cox proportional hazard model||The significance test reported here was for treatment arms comparison in patients not in the male/abnormal LDH stratum.||1.09|0.60|0.18
72477597|NCT01642251|144480993|SUPERIORITY|||||||0.028||||||p value for the interaction by treatment and stratification factor|Regression, Cox|||If there was a significant treatment-by-stratification factor interaction, the results would be reported separately for each stratum. Significance was defined as the p value was less than 0.05.||||0.028
72477598|NCT01642251|144480994|SUPERIORITY||Hazard Ratio (HR)|0.83||||0.17|TWO_SIDED|80.0|0.64|1.07|||Regression, Cox|stratified on the stratification factors used for randomization||||1.07|0.64|0.17
72477599|NCT01642251|144480996|SUPERIORITY|||||||0.13|||||||t-test, 2 sided|||||||0.13
72477600|NCT01445301|144480997|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-11.0|||<|0.001|TWO_SIDED|95.0|-15.0|-7.0|||ANCOVA|||||-7.0|-15.0|<0.001
72477601|NCT01445301|144480997|NON_INFERIORITY|If the upper 95% confidence was less than the pre-defined threshold (-Δ \[non-inferiority margin, -3.8\]) of 3.8, non-inferiority of GSK2585823 once daily to CLDM twice daily would be established|Mean Difference (Net)|-8.2|||<|0.001|TWO_SIDED|95.0|-12.9|-3.6|||ANCOVA|||||-3.6|-12.9|<0.001
72477602|NCT01445301|144480999|NON_INFERIORITY|If the upper 95% confidence was less than the pre-defined threshold (-Δ \[non-inferiority margin, -3.8\]) of 3.8, non-inferiority of GSK2585823 once daily to CLDM twice daily would be established.|Mean Difference (Net)|-3.0|||<|0.001|TWO_SIDED|95.0|-4.4|-1.5|||ANCOVA|||WEEK 1||-1.5|-4.4|<0.001
72477603|NCT01445301|144480999|NON_INFERIORITY|If the upper 95% confidence was less than the pre-defined threshold (-Δ \[non-inferiority margin, -3.8\]) of 3.8, non-inferiority of GSK2585823 once daily to CLDM twice daily would be established|Mean Difference (Net)|-1.8||||0.113|TWO_SIDED|95.0|-4.0|0.4|||ANCOVA|||WEEK 2||0.4|-4.0|0.113
72399761|NCT02921776|144307108|SUPERIORITY|||||||0.291|||||||Mixed Models Analysis|||Opioid Exposure||||0.291
72399762|NCT02921776|144307109|SUPERIORITY||Mean Difference (Final Values)|3.04||||0.38|TWO_SIDED||||||t-test, 2 sided|||||||0.38
72399763|NCT02921776|144307110|SUPERIORITY|||||||0.32|TWO_SIDED|95.0|||||Chi-squared|||||||0.32
72399764|NCT02921776|144307111|SUPERIORITY||Odds Ratio (OR)|0.93||||0.93|TWO_SIDED|95.0|0.19|4.72|||Mixed Models Analysis|||||4.72|0.19|0.93
72399765|NCT02921776|144307112|SUPERIORITY||Mean Difference (Final Values)|10.6||||0.07|TWO_SIDED||||||t-test, 2 sided|||||||0.07
72477604|NCT01445301|144480999|NON_INFERIORITY|If the upper 95% confidence was less than the pre-defined threshold (-Δ \[non-inferiority margin, -3.8\]) of 3.8, non-inferiority of GSK2585823 once daily to CLDM twice daily would be established|Mean Difference (Net)|-2.0||||0.084|TWO_SIDED|95.0|-4.2|0.3|||ANCOVA|||WEEK 4||0.3|-4.2|0.084
72477605|NCT01445301|144480999|NON_INFERIORITY|If the upper 95% confidence was less than the pre-defined threshold (-Δ \[non-inferiority margin, -3.8\]) of 3.8, non-inferiority of GSK2585823 once daily to CLDM twice daily would be established|Mean Difference (Net)|-2.7||||0.026|TWO_SIDED|95.0|-5.1|-0.3|||ANCOVA|||WEEK 8||-0.3|-5.1|0.026
72477606|NCT01445301|144480999|NON_INFERIORITY|If the upper 95% confidence was less than the pre-defined threshold (-Δ \[non-inferiority margin, -3.8\]) of 3.8, non-inferiority of GSK2585823 once daily to CLDM twice daily would be established|Mean Difference (Net)|-2.6||||0.03|TWO_SIDED|95.0|-5.0|-0.3|||ANCOVA|||WEEK 12||-0.3|-5.0|0.030
72477607|NCT01445301|144480999|NON_INFERIORITY|If the upper 95% confidence was less than the pre-defined threshold (-Δ \[non-inferiority margin, -3.8\]) of 3.8, non-inferiority of GSK2585823 once daily to CLDM twice daily would be established|Mean Difference (Net)|-3.4||||0.028|TWO_SIDED|95.0|-6.5|-0.4|||ANCOVA|||WEEK 1||-0.4|-6.5|0.028
72477608|NCT01445301|144480999|NON_INFERIORITY|If the upper 95% confidence was less than the pre-defined threshold (-Δ \[non-inferiority margin, -3.8\]) of 3.8, non-inferiority of GSK2585823 once daily to CLDM twice daily would be established|Mean Difference (Net)|-5.4||||0.004|TWO_SIDED|95.0|-9.1|-1.7|||ANCOVA|||WEEK 2||-1.7|-9.1|0.004
72477609|NCT01445301|144480999|NON_INFERIORITY|If the upper 95% confidence was less than the pre-defined threshold (-Δ \[non-inferiority margin, -3.8\]) of 3.8, non-inferiority of GSK2585823 once daily to CLDM twice daily would be established|Odds Ratio (OR)|-5.8||||0.003|TWO_SIDED|95.0|-9.6|-1.9|||ANCOVA|||WEEK 4||-1.9|-9.6|0.003
72477610|NCT01445301|144480999|NON_INFERIORITY|If the upper 95% confidence was less than the pre-defined threshold (-Δ \[non-inferiority margin, -3.8\]) of 3.8, non-inferiority of GSK2585823 once daily to CLDM twice daily would be established|Mean Difference (Net)|-5.5||||0.006|TWO_SIDED|95.0|-9.4|-1.6|||ANCOVA|||WEEK 8||-1.6|-9.4|0.006
72477611|NCT01445301|144480999|NON_INFERIORITY|If the upper 95% confidence was less than the pre-defined threshold (-Δ \[non-inferiority margin, -3.8\]) of 3.8, non-inferiority of GSK2585823 once daily to CLDM twice daily would be established|Mean Difference (Net)|-5.6||||0.005|TWO_SIDED|95.0|-9.5|-1.7|||ANCOVA|||WEEK 12||-1.7|-9.5|0.005
72399766|NCT02921776|144307114|SUPERIORITY|||||||0.71|||||||t-test, 2 sided|||||||0.71
72399767|NCT02921776|144307115|SUPERIORITY|||||||0.94|||||||t-test, 2 sided|||Baseline||||0.94
72399768|NCT02921776|144307115|SUPERIORITY|||||||0.89|||||||t-test, 2 sided|||Patient Extubation or Discharge from ICU||||0.89
72477612|NCT01445301|144480999|SUPERIORITY||Mean Difference (Net)|-2.5|||<|0.001|TWO_SIDED|95.0|-3.9|-1.1|||ANCOVA|||WEEK 1||-1.1|-3.9|<0.001
72477613|NCT01445301|144480999|SUPERIORITY||Mean Difference (Net)|-3.2|||<|0.001|TWO_SIDED|95.0|-4.7|-1.6|||ANCOVA|||WEEK 2||-1.6|-4.7|<0.001
72477614|NCT01445301|144480999|SUPERIORITY||Mean Difference (Net)|-2.5||||0.002|TWO_SIDED|95.0|-4.1|-0.9|||ANCOVA|||WEEK 4||-0.9|-4.1|0.002
72477615|NCT01445301|144480999|SUPERIORITY||Mean Difference (Net)|-2.7||||0.003|TWO_SIDED|95.0|-4.5|-0.9|||ANCOVA|||WEEK 8||-0.9|-4.5|0.003
72477616|NCT01445301|144480999|SUPERIORITY||Mean Difference (Net)|-2.8||||0.002|TWO_SIDED|95.0|-4.6|-1.0|||ANCOVA|||WEEK 12||-1.0|-4.6|0.002
72477617|NCT01445301|144480999|SUPERIORITY||Mean Difference (Net)|-6.0|||<|0.001|TWO_SIDED|95.0|-8.8|-3.2|||ANCOVA|||WEEK 1||-3.2|-8.8|<0.001
72477618|NCT01445301|144480999|SUPERIORITY||Mean Difference (Net)|-8.1|||<|0.001|TWO_SIDED|95.0|-11.4|-4.7|||ANCOVA|||WEEK 2||-4.7|-11.4|<0.001
72477619|NCT01445301|144480999|SUPERIORITY||Mean Difference (Net)|-9.7|||<|0.001|TWO_SIDED|95.0|-13.1|-6.2|||ANCOVA|||WEEK 4||-6.2|-13.1|<0.001
72477620|NCT01445301|144480999|SUPERIORITY||Mean Difference (Net)|-8.6|||<|0.001|TWO_SIDED|95.0|-12.1|-5.1|||ANCOVA|||WEEK 8||-5.1|-12.1|<0.001
72477621|NCT01445301|144480999|SUPERIORITY||Mean Difference (Net)|-8.2|||<|0.001|TWO_SIDED|95.0|-11.6|-4.8|||ANCOVA|||WEEK 12||-4.8|-11.6|<0.001
72508818|NCT02749721|144548167|OTHER||Pearson's R|0.231||||0.373|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P200 (latency) and HDRS-17 baseline to endpoint percent change||||0.373
72399769|NCT02921776|144307115|SUPERIORITY|||||||0.38|||||||t-test, 2 sided|||1-Month||||0.38
72399770|NCT02921776|144307115|SUPERIORITY|||||||0.63|||||||t-test, 2 sided|||3-Month||||0.63
72508819|NCT02749721|144548167|OTHER||Pearson's R|0.019||||0.949|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P3a (latency) and HDRS-17 baseline to endpoint percent change||||0.949
72399771|NCT02921776|144307115|SUPERIORITY|||||||0.73|||||||t-test, 2 sided|||||||.73
72399772|NCT02921776|144307116|SUPERIORITY|||||||0.82|||||||t-test, 2 sided|||Baseline||||0.82
72399773|NCT02921776|144307116|SUPERIORITY|||||||0.84|||||||t-test, 2 sided|||Patient extubation or discharge from ICU||||0.84
72399774|NCT02921776|144307116|SUPERIORITY|||||||0.96|||||||t-test, 2 sided|||1-month||||0.96
72399775|NCT02921776|144307116|SUPERIORITY|||||||0.17|||||||t-test, 2 sided|||3-Month||||0.17
72399776|NCT02921776|144307116|SUPERIORITY|||||||0.39|||||||t-test, 2 sided|||||||.39
72399777|NCT02921776|144307117|SUPERIORITY|||||||0.26|||||||Wilcoxon (Mann-Whitney)|||1-month||||0.26
72399778|NCT02921776|144307117|SUPERIORITY|||||||0.25|||||||Wilcoxon (Mann-Whitney)|||3-month||||0.25
72399779|NCT02921776|144307117|SUPERIORITY|||||||0.79|||||||Wilcoxon (Mann-Whitney)|||6-month||||0.79
72399780|NCT02921776|144307125|SUPERIORITY||Odds Ratio (OR)|0.23||||0.05|TWO_SIDED|95.0|0.05|1.01|||t-test, 2 sided|||||1.01|0.05|0.05
72399781|NCT02921776|144307125|SUPERIORITY||Odds Ratio (OR)|0.27||||0.1|TWO_SIDED|95.0|0.06|1.3|||Regression, Linear|||Adjusted for baseline communication difficulty||1.30|0.06|0.10
72477622|NCT01445301|144481000|NON_INFERIORITY_OR_EQUIVALENCE|If the upper 95% confidence was less than the pre-defined threshold (-Δ \[non-inferiority margin, -3.8\]) of 3.8, non-inferiority of GSK2585823 once daily to CLDM twice daily would be established|Mean Difference (Net)|-7.71|||<|0.001|TWO_SIDED|95.0|-11.3|-4.12|||ANCOVA|||Total Lesion Counts, WEEK 1||-4.12|-11.30|<0.001
72477623|NCT01445301|144481000|NON_INFERIORITY_OR_EQUIVALENCE|If the upper 95% confidence was less than the pre-defined threshold (-Δ \[non-inferiority margin, -3.8\]) of 3.8, non-inferiority of GSK2585823 once daily to CLDM twice daily would be established|Mean Difference (Net)|-8.51|||<|0.001|TWO_SIDED|95.0|-13.24|-3.77|||ANCOVA|||Total Lesion Counts, WEEK 2||-3.77|-13.24|<0.001
72477624|NCT01445301|144481000|NON_INFERIORITY_OR_EQUIVALENCE|If the upper 95% confidence was less than the pre-defined threshold (-Δ \[non-inferiority margin, -3.8\]) of 3.8, non-inferiority of GSK2585823 once daily to CLDM twice daily would be established.|Mean Difference (Net)|-8.89|||<|0.001|TWO_SIDED|95.0|-13.37|-4.41|||ANCOVA|||Total Lesion Counts, WEEK 4||-4.41|-13.37|<0.001
72477625|NCT01445301|144481000|NON_INFERIORITY_OR_EQUIVALENCE|If the upper 95% confidence was less than the pre-defined threshold (-Δ \[non-inferiority margin, -3.8\]) of 3.8, non-inferiority of GSK2585823 once daily to CLDM twice daily would be established.|Mean Difference (Net)|-9.12|||<|0.001|TWO_SIDED|95.0|-13.82|-4.43|||ANCOVA|||Total Lesion Counts, WEEK 8||-4.43|-13.82|<0.001
72477626|NCT01445301|144481000|NON_INFERIORITY_OR_EQUIVALENCE|If the upper 95% confidence was less than the pre-defined threshold (-Δ \[non-inferiority margin, -3.8\]) of 3.8, non-inferiority of GSK2585823 once daily to CLDM twice daily would be established.|Mean Difference (Net)|-9.43|||<|0.001|TWO_SIDED|95.0|-14.11|-4.75|||ANCOVA|||Total Lesion Counts, WEEK 12||-4.75|-14.11|<0.001
72477627|NCT01445301|144481000|NON_INFERIORITY_OR_EQUIVALENCE|If the upper 95% confidence was less than the pre-defined threshold (-Δ \[non-inferiority margin, -3.8\]) of 3.8, non-inferiority of GSK2585823 once daily to CLDM twice daily would be established.|Mean Difference (Net)|-10.54|||<|0.001|TWO_SIDED|95.0|-15.12|-5.97|||ANCOVA|||Inflammatory Lesion Counts, WEEK 1||-5.97|-15.12|<0.001
72477628|NCT01445301|144481000|NON_INFERIORITY_OR_EQUIVALENCE|If the upper 95% confidence was less than the pre-defined threshold (-Δ \[non-inferiority margin, -3.8\]) of 3.8, non-inferiority of GSK2585823 once daily to CLDM twice daily would be established|Mean Difference (Net)|-7.21||||0.011|TWO_SIDED|95.0|-12.73|-1.69|||ANCOVA|||Inflammatory Lesion Counts, WEEK 2||-1.69|-12.73|0.011
72477629|NCT01445301|144481000|NON_INFERIORITY_OR_EQUIVALENCE|If the upper 95% confidence was less than the pre-defined threshold (-Δ \[non-inferiority margin, -3.8\]) of 3.8, non-inferiority of GSK2585823 once daily to CLDM twice daily would be established.|Mean Difference (Net)|-7.64||||0.005|TWO_SIDED|95.0|-12.93|-2.35|||ANCOVA|||Inflammatory Lesion Counts, WEEK 4||-2.35|-12.93|0.005
72477630|NCT01445301|144481000|NON_INFERIORITY_OR_EQUIVALENCE|If the upper 95% confidence was less than the pre-defined threshold (-Δ \[non-inferiority margin, -3.8\]) of 3.8, non-inferiority of GSK2585823 once daily to CLDM twice daily would be established.|Mean Difference (Net)|-8.73||||0.002|TWO_SIDED|95.0|-14.2|-3.26|||ANCOVA|||Inflammatory Lesion Counts, WEEK 8||-3.26|-14.20|0.002
72623361|NCT04562090|144777424|SUPERIORITY|Statistical testing was conducted using 2-sided at a significance level of 0.05.|LS Mean|-3.2|STANDARD_ERROR_OF_MEAN|0.51|<|0.001|TWO_SIDED|95.0|-4.2|-2.2||RMA: CFB as response, TG, visit (week 4, 8), pooled site, sex and the interaction between TG and visit as fixed effects and mean number of micturitions per 24 hours at baseline as covariate.|MMRM|||Week 8||-2.20|-4.20|<0.001
72399782|NCT05478252|144307170|NON_INFERIORITY|Non-inferiority of insulin semaglutide J versus insulin semaglutide B was considered as confirmed if the 95% confidence interval (CI) for the mean treatment difference lied entirely below 2.5%. Non-inferiority was investigated on the FAS.|Treatment difference|-0.11|||<|0.0001|TWO_SIDED|95.0|-0.3|0.08|||ANCOVA|||||0.08|-0.30|<.0001
72477631|NCT01445301|144481000|NON_INFERIORITY_OR_EQUIVALENCE|If the upper 95% confidence was less than the pre-defined threshold (-Δ \[non-inferiority margin, -3.8\]) of 3.8, non-inferiority of GSK2585823 once daily to CLDM twice daily would be established.|Mean Difference (Net)|-8.2||||0.002|TWO_SIDED|95.0|-13.34|-3.06|||ANCOVA|||Inflammatory Lesion Counts, WEEK 12||-3.06|-13.34|0.002
72477632|NCT01445301|144481000|NON_INFERIORITY_OR_EQUIVALENCE|If the upper 95% confidence was less than the pre-defined threshold (-Δ \[non-inferiority margin, -3.8\]) of 3.8, non-inferiority of GSK2585823 once daily to CLDM twice daily would be established.|Mean Difference (Net)|-5.8||||0.011|TWO_SIDED|95.0|-10.29|-1.32|||ANCOVA|||Non-Inflammatory Lesion Counts, WEEK 1||-1.32|-10.29|0.011
72477633|NCT01445301|144481000|NON_INFERIORITY_OR_EQUIVALENCE|If the upper 95% confidence was less than the pre-defined threshold (-Δ \[non-inferiority margin, -3.8\]) of 3.8, non-inferiority of GSK2585823 once daily to CLDM twice daily would be established.|Mean Difference (Net)|-8.3||||0.005|TWO_SIDED|95.0|-14.1|-2.5|||ANCOVA|||Non-Inflammatory Lesion Counts, WEEK 2||-2.50|-14.10|0.005
72477634|NCT01445301|144481000|NON_INFERIORITY_OR_EQUIVALENCE|If the upper 95% confidence was less than the pre-defined threshold (-Δ \[non-inferiority margin, -3.8\]) of 3.8, non-inferiority of GSK2585823 once daily to CLDM twice daily would be established.|Mean Difference (Net)|-9.27|||<|0.001|TWO_SIDED|95.0|-14.72|-3.83|||ANCOVA|||Non-Inflammatory Lesion Counts, WEEK 4||-3.83|-14.72|<0.001
72477635|NCT01445301|144481000|NON_INFERIORITY_OR_EQUIVALENCE|If the upper 95% confidence was less than the pre-defined threshold (-Δ \[non-inferiority margin, -3.8\]) of 3.8, non-inferiority of GSK2585823 once daily to CLDM twice daily would be established.|Mean Difference (Net)|-8.84||||0.002|TWO_SIDED|95.0|-14.28|-3.39|||ANCOVA|||Non-Inflammatory Lesion Counts, WEEK 8||-3.39|-14.28|0.002
72477636|NCT01445301|144481000|NON_INFERIORITY_OR_EQUIVALENCE|If the upper 95% confidence was less than the pre-defined threshold (-Δ \[non-inferiority margin, -3.8\]) of 3.8, non-inferiority of GSK2585823 once daily to CLDM twice daily would be established.|Mean Difference (Net)|-9.68|||<|0.001|TWO_SIDED|95.0|-15.06|-4.3|||ANCOVA|||Non-Inflammatory Lesion Counts, WEEK 12||-4.30|-15.06|<0.001
72477637|NCT01445301|144481000|SUPERIORITY||Mean Difference (Net)|-8.9|||<|0.001|TWO_SIDED|95.0|-12.32|-5.48|||ANCOVA|||Total Lesion Counts, WEEK 1||-5.48|-12.32|<0.001
72477638|NCT01445301|144481000|SUPERIORITY||Mean Difference (Net)|-11.17|||<|0.001|TWO_SIDED|95.0|-15.18|-7.16|||ANCOVA|||Total Lesion Counts, WEEK 2||-7.16|-15.18|<0.001
72477639|NCT01445301|144481000|SUPERIORITY||Mean Difference (Net)|-12.12|||<|0.001|TWO_SIDED|95.0|-15.9|-8.35|||ANCOVA|||Total Lesion Counts, WEEK 4||-8.35|-15.90|<0.001
72477640|NCT01445301|144481000|SUPERIORITY||Mean Difference (Net)|-11.33|||<|0.001|TWO_SIDED|95.0|-15.37|-7.3|||ANCOVA|||Total Lesion Counts, WEEK 8||-7.30|-15.37|<0.001
72508820|NCT02749721|144548167|OTHER||Pearson's R|0.122||||0.754|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P3b (latency) and HDRS-17 baseline to endpoint percent change||||0.754
72508821|NCT02749721|144548167|OTHER||Pearson's R|0.176||||0.499|TWO_SIDED||||||0.176|||Correlation between VGNG P200 (latency) and HDRS-17 baseline to endpoint percent change||||0.499
72477641|NCT01445301|144481000|SUPERIORITY||Mean Difference (Net)|-11.18|||<|0.001|TWO_SIDED|95.0|-15.11|-7.25|||ANCOVA|||Total Lesion Counts, WEEK 12||-7.25|-15.11|<0.001
72477642|NCT01445301|144481000|SUPERIORITY||Mean Difference (Net)|-8.32|||<|0.001|TWO_SIDED|95.0|-12.76|-3.88|||ANCOVA|||Inflammatory Lesion Counts, WEEK 1||-3.88|-12.76|<0.001
72477643|NCT01445301|144481000|SUPERIORITY||Mean Difference (Net)|-9.57|||<|0.001|TWO_SIDED|95.0|-13.83|-5.3|||ANCOVA|||Inflammatory Lesion Counts, WEEK 2||-5.30|-13.83|<0.001
72477644|NCT01445301|144481000|SUPERIORITY||Mean Difference (Net)|-7.83|||<|0.001|TWO_SIDED|95.0|-12.03|-3.62|||ANCOVA|||Inflammatory Lesion Counts, WEEK 4||-3.62|-12.03|<0.001
72477645|NCT01445301|144481000|SUPERIORITY||Mean Difference (Net)|-8.08|||<|0.001|TWO_SIDED|95.0|-12.63|-3.53|||ANCOVA|||Inflammatory Lesion Counts, WEEK 8||-3.53|-12.63|<0.001
72477646|NCT01445301|144481000|SUPERIORITY||Mean Difference (Net)|-8.56|||<|0.001|TWO_SIDED|95.0|-12.71|-4.41|||ANCOVA|||Inflammatory Lesion Counts, WEEK 12||-4.41|-12.71|<0.001
72477647|NCT01445301|144481000|SUPERIORITY||Mean Difference (Net)|-9.11|||<|0.001|TWO_SIDED|95.0|-13.53|-4.68|||ANCOVA|||Non-Inflammatory Lesion Counts, WEEK 1||-4.68|-13.53|<0.001
72477648|NCT01445301|144481000|SUPERIORITY||Mean Difference (Net)|-11.05|||<|0.001|TWO_SIDED|95.0|-16.3|-5.8|||ANCOVA|||Non-Inflammatory Lesion Counts, WEEK 2||-5.80|-16.30|<0.001
72477649|NCT01445301|144481000|SUPERIORITY||Mean Difference (Net)|-14.17|||<|0.001|TWO_SIDED|95.0|-18.97|-9.37|||ANCOVA|||Non-Inflammatory Lesion Counts, WEEK 4||-9.37|-18.97|<0.001
72477650|NCT01445301|144481000|SUPERIORITY||Mean Difference (Net)|-13.04|||<|0.001|TWO_SIDED|95.0|-17.83|-8.25|||ANCOVA|||Non-Inflammatory Lesion Counts, WEEK 8||-8.25|-17.83|<0.001
72477651|NCT01445301|144481000|SUPERIORITY||Mean Difference (Net)|-12.37|||<|0.001|TWO_SIDED|95.0|-17.05|-7.68|||ANCOVA|||Non-Inflammatory Lesion Counts, WEEK 12||-7.68|-17.05|<0.001
72477652|NCT01445301|144481001|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel|||||||<0.001
72477653|NCT01445301|144481001|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel|||||||<0.001
72477654|NCT01445301|144481002|SUPERIORITY_OR_OTHER|||||||0.47||95.0|||||Cochran-Mantel-Haenszel|||Comparison of ISGA Score of 0 or 1 between GSK2585823 twice daily and CLDM twice daily at Week 1||||0.470
72477655|NCT01445301|144481002|SUPERIORITY_OR_OTHER|||||||0.844||95.0|||||Cochran-Mantel-Haenszel|||Comparison of ISGA Score of 0 or 1 between GSK2585823 twice daily and CLDM twice daily at Week 2||||0.844
72623362|NCT04562090|144777424|SUPERIORITY|Statistical testing was conducted using 2-sided at a significance level of 0.05.|LS Mean|-2.92|STANDARD_ERROR_OF_MEAN|0.28|<|0.001|TWO_SIDED|95.0|-3.47|-2.37||RMA: CFB as response, TG, visit (week 4, 8), pooled site, sex and the interaction between TG and visit as fixed effects and mean number of micturitions per 24 hours at baseline as covariate.|MMRM|||Week 8||-2.37|-3.47|<0.001
72477656|NCT01445301|144481002|SUPERIORITY_OR_OTHER|||||||0.022||95.0|||||Cochran-Mantel-Haenszel|||Comparison of ISGA Score of 0 or 1 between GSK2585823 twice daily and CLDM twice daily at Week 4||||0.022
72477657|NCT01445301|144481002|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel|||Comparison of ISGA Score of 0 or 1 between GSK2585823 twice daily and CLDM twice daily at Week 8||||<0.001
72477658|NCT01445301|144481002|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel|||Comparison of ISGA Score of 0 or 1 between GSK2585823 twice daily and CLDM twice daily at Week 12||||<0.001
72477659|NCT01445301|144481002|SUPERIORITY_OR_OTHER|||||||0.572||95.0|||||Cochran-Mantel-Haenszel|||Comparison of ISGA Score of 0 or 1 between GSK2585823 once daily and CLDM twice daily at Week 1||||0.572
72623363|NCT03312543|144777435|SUPERIORITY|Superiority to baseline concluded if the lower bound of the 95% confidence interval for the mean difference is above 0.5.|Mean Difference (Net)|0.18|STANDARD_DEVIATION|0.328|<|0.001|TWO_SIDED|95.0|0.09|0.26|||t-test, 2 sided|||||0.26|0.09|<0.001
72477660|NCT01445301|144481002|SUPERIORITY_OR_OTHER|||||||0.335||95.0|||||Cochran-Mantel-Haenszel|||Comparison of ISGA Score of 0 or 1 between GSK2585823 once daily and CLDM twice daily at Week 2||||0.335
72477661|NCT01445301|144481002|SUPERIORITY_OR_OTHER|||||||0.187||95.0|||||Cochran-Mantel-Haenszel|||Comparison of ISGA Score of 0 or 1 between GSK2585823 once daily and CLDM twice daily at Week 4||||0.187
72477662|NCT01445301|144481002|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel|||Comparison of ISGA Score of 0 or 1 between GSK2585823 once daily and CLDM twice daily at Week 8||||<0.001
72477663|NCT01445301|144481002|SUPERIORITY_OR_OTHER|||||||0.006||95.0|||||Cochran-Mantel-Haenszel|||Comparison of ISGA Score of 0 or 1 between GSK2585823 once daily and CLDM twice daily at Week 12||||0.006
72477664|NCT01445301|144481003|SUPERIORITY_OR_OTHER|||||||0.002|||||||Cochran-Mantel-Haenszel|||Comparison of GSK2585823 twice daily and CLDM twice daily at Week 1||||0.002
72477665|NCT01445301|144481003|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||Comparison of GSK2585823 twice daily and CLDM twice daily at Week 2||||<0.001
72477666|NCT01445301|144481003|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||Comparison of GSK2585823 twice daily and CLDM twice daily at Week 4||||<0.001
72477667|NCT01445301|144481003|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||Comparison of GSK2585823 twice daily and CLDM twice daily at Week 8||||<0.001
72508822|NCT02749721|144548167|OTHER||Pearson's R|-0.162||||0.549|TWO_SIDED||||||Pearson's correlation|||Correlation between VGNG P3a (latency) and HDRS-17 baseline to endpoint percent change||||0.549
72477668|NCT01445301|144481003|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||Comparison of GSK2585823 twice daily and CLDM twice daily at Week 12||||<0.001
72477669|NCT01445301|144481003|SUPERIORITY_OR_OTHER|||||||0.48|||||||Cochran-Mantel-Haenszel|||Comparison of GSK2585823 once daily and CLDM twice daily at Week 1||||0.480
72477670|NCT01445301|144481003|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||Comparison of GSK2585823 once daily and CLDM twice daily at Week 2||||<0.001
72477671|NCT01445301|144481003|SUPERIORITY_OR_OTHER|||||||0.009|||||||Cochran-Mantel-Haenszel|||Comparison of GSK2585823 once daily and CLDM twice daily at Week 4||||0.009
72477672|NCT01445301|144481003|SUPERIORITY_OR_OTHER|||||||0.008|||||||Cochran-Mantel-Haenszel|||Comparison of GSK2585823 once daily and CLDM twice daily at Week 8||||0.008
72477673|NCT01445301|144481003|SUPERIORITY_OR_OTHER|||||||0.065|||||||Cochran-Mantel-Haenszel|||Comparison of GSK2585823 once daily and CLDM twice daily at Week 12||||0.065
72477674|NCT04493502|144481045|SUPERIORITY||Mean Difference (Final Values)|17.1||||0.189|TWO_SIDED|95.0|-7.3|41.4|||Regression, Logistic|||||41.4|-7.3|0.189
72477675|NCT04493502|144481046|SUPERIORITY||Mean Difference (Final Values)|-4.67||||0.024|TWO_SIDED|95.0|-8.69|-0.64|||ANCOVA|||||-0.64|-8.69|0.024
72477676|NCT04493502|144481047|SUPERIORITY||Mean Difference (Final Values)|0.05||||0.949|TWO_SIDED|95.0|-1.44|1.53|||ANCOVA|||||1.53|-1.44|0.949
72477677|NCT02891837|144481050|OTHER|||||||0.493|||||||Wilcoxon (Mann-Whitney)|||||||0.4930
72477678|NCT02891837|144481052|OTHER|||||||0.1924|||||||Wilcoxon (Mann-Whitney)|||||||0.1924
72477679|NCT02891837|144481053|OTHER|||||||0.8678|||||||Wilcoxon (Mann-Whitney)|||||||0.8678
72477680|NCT02891837|144481060|OTHER|||||||0.6422|||||||Wilcoxon (Mann-Whitney)|||||||0.6422
72477681|NCT02891837|144481061|OTHER|||||||0.7572|||||||Wilcoxon (Mann-Whitney)|||||||0.7572
72477682|NCT02891837|144481063|OTHER|||||||0.3681|||||||Wilcoxon (Mann-Whitney)|||||||0.3681
72477683|NCT02891837|144481067|OTHER|"Sample size calculated with nQuery 7.0. Assumed standard deviation = 50 h, \& mean values of 44 h (placebo) \& 14 h (L-citrulline group), estimated effect size = 0.600, yielding a sample size N=92/group (two-sided Wilcoxon-rank-sum test with 0.01 significance level and 90% power). Assumptions for standard deviation \& mean based on Study CIT-002-01 results.~To allow for subjects being enrolled but not assigned to the full analysis set (FAS), an overall N=95 subjects per group were to be enrolled."|Location shift|219.0||||0.156|TWO_SIDED|95.0|-88.0|626.0||The threshold for statistical significance was p = 0.05|Wilcoxon (Mann-Whitney)||Treatment difference = L-citrulline - placebo For the mean and median values, that the estimated values are given in minutes \[min\]|H0: Composite endpoint in L-citrulline group = placebo group H1: Composite endpoint in L-citrulline group ≠ placebo group H0 tested using Wilcoxon-rank-sum test. Significance level = 1% (2-sided).||626.0|-88.0|0.1560
72477684|NCT02891837|144481067|OTHER||Location shift|813.1||||0.1627|TWO_SIDED|95.0|-335.5|1961.6||The threshold for statistical significance was 0.05.|t-test, 2 sided|The results of the T-test should be interpreted with caution since the endpoint is not normally distributed.|Treatment difference = L-citrulline - placebo. For the mean and median values, the estimated values are given in minutes|Post hoc analyses were done for US patients on mechanical ventilation for \<=48 hours. For all post hoc analyses a significance level of 5% was applied.||1961.6|-335.5|0.1627
72508823|NCT02749721|144548167|OTHER||Pearson's R|-0.126||||0.617|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P200 (latency) and QIDS-SR baseline scores||||0.617
72623364|NCT03312543|144777435|SUPERIORITY|Superiority to baseline concluded if the lower bound of the 95% confidence interval for the mean difference is above 0.5.|Mean Difference (Net)|0.3|STANDARD_DEVIATION|0.341|<|0.001|TWO_SIDED|95.0|0.21|0.39|||t-test, 2 sided|||||0.39|0.21|<0.001
72623365|NCT03312543|144777435|OTHER|The null hypothesis was that the change from baseline to Week 12 was equal for the active cell and the sham cell. The alternative hypothesis was that the mean change from Baseline was not equal between the two cells.|Mean Difference (Net)|0.14|STANDARD_ERROR_OF_MEAN|0.06||0.025|TWO_SIDED|95.0|0.02|0.25|||ANCOVA|With treatment and skin type group as factors and the corresponding averaged baseline score as a covariate.||||0.25|0.02|0.025
72623366|NCT03312543|144777436|SUPERIORITY|Superiority to baseline concluded if the lower bound of the 95% confidence interval for the mean difference is above 0.5.|Mean Difference (Net)|0.2|STANDARD_DEVIATION|0.349|<|0.001|TWO_SIDED|95.0|0.11|0.29|||t-test, 2 sided|||||0.29|0.11|<0.001
72623367|NCT03312543|144777436|SUPERIORITY|Superiority to baseline concluded if the lower bound of the 95% confidence interval for the mean difference is above 0.5.|Mean Difference (Net)|0.22|STANDARD_DEVIATION|0.328|<|0.001|TWO_SIDED|95.0|0.13|0.31|||t-test, 2 sided|||||0.31|0.13|<0.001
72623368|NCT03312543|144777436|EQUIVALENCE|The null hypothesis was that the change from baseline to Week 12 was equal for the active cell and the sham cell. The alternative hypothesis was that the mean change from Baseline was not equal between the two cells.|Mean Difference (Net)|0.04|STANDARD_ERROR_OF_MEAN|0.062||0.54|TWO_SIDED|95.0|-0.09|0.16|||ANCOVA|With treatment and skin type group as factors and the corresponding averaged baseline score as a covariate.||||0.16|-0.09|0.540
72623369|NCT03312543|144777437|SUPERIORITY|Superiority to baseline concluded if the lower bound of the 95% confidence interval for the mean difference is above 0.5.|Mean Difference (Net)|-0.03|STANDARD_DEVIATION|0.532||0.627|TWO_SIDED|95.0|-0.17|0.1|||t-test, 2 sided|||||0.10|-0.17|0.627
72623370|NCT03312543|144777437|SUPERIORITY|Superiority to baseline concluded if the lower bound of the 95% confidence interval for the mean difference is above 0.5.|Mean Difference (Net)|0.21|STANDARD_DEVIATION|0.5||0.002|TWO_SIDED|95.0|0.08|0.34|||t-test, 2 sided|||||0.34|0.08|0.002
72477685|NCT02891837|144481075|OTHER|||||||0.0326||||||The threshold for statistical significance was 0.05.|ANOVA|||"Values at 48 hours post-surgery start for all US patients on ventilation for ≤48 hours are presented.~Treatment group, baseline values and site were included as fixed factors, site\*treatment as interaction terms in this ANOVA. The normality assumption of residuals is critical for all considered timepoints. Please interpret results with caution."||||0.0326
72623371|NCT03312543|144777437|EQUIVALENCE|The null hypothesis was that the change from baseline to Week 12 was equal for the active cell and the sham cell. The alternative hypothesis was that the mean change from Baseline was not equal between the two cells.|Mean Difference (Net)|0.24|STANDARD_ERROR_OF_MEAN|0.092||0.009|TWO_SIDED|95.0|0.06|0.42|||ANCOVA|With treatment and skin type group as factors and the corresponding averaged baseline score as a covariate.||||0.42|0.06|0.009
72477686|NCT02891837|144481075|OTHER|||||||0.0026||||||The threshold for statistical significance was 0.05.|ANOVA|||"Values at 48 hours post-surgery start for ALL patients on ventilation for ≤48 hours are presented.~Treatment group, baseline values and site were included as fixed factors, site\*treatment as interaction terms in this ANOVA. The normality assumption of residuals is critical for all considered timepoints. Please interpret results with caution."||||0.0026
72477687|NCT02632526|144481087|SUPERIORITY_OR_OTHER||Slope|1.24|STANDARD_ERROR_OF_MEAN|0.0433|||TWO_SIDED|90.0|1.17|1.31||||||||1.31|1.17|
72477688|NCT02632526|144481087|SUPERIORITY_OR_OTHER||Slope|0.322|STANDARD_ERROR_OF_MEAN|0.182|||TWO_SIDED|90.0|-0.0124|0.656||||||||0.656|-0.0124|
72477689|NCT02632526|144481088|SUPERIORITY_OR_OTHER||Slope|1.22|STANDARD_ERROR_OF_MEAN|0.0813|||TWO_SIDED|90.0|1.08|1.36||||||Day 1||1.36|1.08|
72477690|NCT02632526|144481090|SUPERIORITY_OR_OTHER||Slope|1.23|STANDARD_ERROR_OF_MEAN|0.0851|||TWO_SIDED|90.0|1.08|1.38||||||Day 10||1.38|1.08|
72477691|NCT02632526|144481091|SUPERIORITY_OR_OTHER||Slope|1.55|STANDARD_ERROR_OF_MEAN|0.0692|||TWO_SIDED|90.0|1.43|1.66||||||||1.66|1.43|
72623372|NCT03312543|144777438|SUPERIORITY|Superiority to baseline concluded if the lower bound of the 95% confidence interval for the mean difference is above 0.5.|Mean Difference (Net)|0.36|STANDARD_DEVIATION|0.465|<|0.001|TWO_SIDED|95.0|0.23|0.48|||t-test, 2 sided|||||0.48|0.23|<0.001
72477692|NCT02632526|144481091|SUPERIORITY_OR_OTHER||Slope|0.35|STANDARD_ERROR_OF_MEAN|0.176|||TWO_SIDED|90.0|0.0315|0.669||||||||0.669|0.0315|
72477693|NCT02632526|144481092|SUPERIORITY_OR_OTHER||Slope|1.48|STANDARD_ERROR_OF_MEAN|0.0839|||TWO_SIDED|90.0|1.34|1.63||||||For Day 1||1.63|1.34|
72477694|NCT02632526|144481092|SUPERIORITY_OR_OTHER||Slope|1.43|STANDARD_ERROR_OF_MEAN|0.104|||TWO_SIDED|90.0|1.25|1.6||||||Day 10||1.60|1.25|
72477695|NCT02632526|144481105|SUPERIORITY_OR_OTHER||Ratio|28.13|||||TWO_SIDED|90.0|20.98|37.73||||||Cmax||37.73|20.98|
72477696|NCT02632526|144481106|SUPERIORITY_OR_OTHER||Ratio|64.58|||||TWO_SIDED|90.0|54.34|76.74||||||AUC(0-τ)||76.74|54.34|
72477697|NCT02751320|144481116|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.09||||0.7603|TWO_SIDED|95.0|-8.11|5.94||From ANCOVA: Participant (random), treatment \& period (fixed), subject-level baseline SMH, period-level baseline SMH, subject-level pre-treatment acid challenge SMH and period-level pre-treatment acid challenge SMH (covariates).|ANCOVA||Difference is first named treatment minus second named treatment such that positive difference favors the first named treatment.|||5.94|-8.11|0.7603
72477698|NCT02751320|144481116|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.3||||0.3555|TWO_SIDED|95.0|-10.34|3.74||From ANCOVA: Participant (random), treatment \& period (fixed), subject-level baseline SMH, period-level baseline SMH, subject-level pre-treatment acid challenge SMH and period-level pre-treatment acid challenge SMH (covariates).|ANCOVA||Difference is first named treatment minus second named treatment such that positive difference favors the first named treatment.|||3.74|-10.34|0.3555
72477699|NCT02751320|144481116|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.21||||0.5335|TWO_SIDED|95.0|-4.81|9.23||ANCOVA: Participant (random), treatment \& period (fixed), Participant-level baseline SMH, period-level baseline SMH, Participant-level pre-treatment acid challenge SMH and period-level pre-treatment acid challenge SMH (covariates)|ANCOVA||Difference is first named treatment minus second named treatment such that positive difference favors the first named treatment.|||9.23|-4.81|0.5335
72508824|NCT02749721|144548167|OTHER||Pearson's R|0.1||||0.722|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P3a (latency) and QIDS-SR baseline scores||||0.722
72477700|NCT02751320|144481116|SUPERIORITY_OR_OTHER||Mean Difference (Net)|22.96|||<|0.0001|TWO_SIDED|95.0|16.02|29.9||From ANCOVA: Participant (random), treatment \& period (fixed), Participant -level baseline SMH, period-level baseline SMH, Participant -level pre-treatment acidchallenge SMH and period-level pre-treatment acid challenge SMH (covariates) .|ANCOVA||Difference is first named treatment minus second named treatment such that positive difference favors the first named treatment.|Treatment comparison corresponding to qualifying criteria for the analysis||29.90|16.02|<.0001
72477701|NCT03954392|144481127|OTHER||||||<|0.05|||||||ANCOVA|Only one statistical test was conducted, therefore no adjustments for multiple comparisons was needed.||Statistical analysis will compare the post-intervention scores on the primary outcome (Faux Pas Recognition Test scores), controlling for pre-intervention scores.||||< 0.05
72477702|NCT03954392|144481128|OTHER||||||<|0.05|||||||ANCOVA|||||||< 0.05
72477703|NCT01226095|144481328|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||||||<0.0001
72477704|NCT03143166|144481383|OTHER||Adjusted gMean ratio Test/Reference (%)|28.85|STANDARD_ERROR_OF_MEAN|86.7|||TWO_SIDED|90.0|21.346|38.996|||ANOVA|An analysis of variance (ANOVA) was used on the logarithmic scale including effects for 'subjects' and 'treatment'.|The dispersion value standard error of the mean is actually intra individual geometric coefficient of variation (gCV) (%).|||38.996|21.346|
72477705|NCT03143166|144481384|OTHER||Adjusted gMean ratio Test/Reference (%)|26.37|STANDARD_ERROR_OF_MEAN|76.6|||TWO_SIDED|90.0|20.066|34.665|||ANOVA|An analysis of variance (ANOVA) was used on the logarithmic scale including effects for 'subjects' and 'treatment'.|The dispersion value standard error of the mean is actually intra individual geometric coefficient of variation (gCV) (%).|||34.665|20.066|
72477706|NCT03143166|144481385|OTHER||Adjusted gMean ratio Test/Reference (%)|28.02|STANDARD_ERROR_OF_MEAN|83.4|||TWO_SIDED|90.0|20.914|37.537|||ANOVA|An analysis of variance (ANOVA) was used on the logarithmic scale including effects for 'subjects' and 'treatment'.|The dispersion value standard error of the mean is actually intra individual geometric coefficient of variation (gCV) (%).|||37.537|20.914|
72477707|NCT03143166|144481386|OTHER||Adjusted gMean ratio Test/Reference (%)|27.56|STANDARD_ERROR_OF_MEAN|75.6|||TWO_SIDED|90.0|21.023|36.118|||ANOVA|An analysis of variance (ANOVA) was used on the logarithmic scale including effects for 'subjects' and 'treatment'.|The dispersion value standard error of the mean is actually intra individual geometric coefficient of variation (gCV) (%).|||36.118|21.023|
72477708|NCT03143166|144481387|OTHER||Adjusted gMean ratio Test/Reference (%)|30.59|STANDARD_ERROR_OF_MEAN|76.8|||TWO_SIDED|90.0|23.26|40.234|||ANOVA|An analysis of variance (ANOVA) was used on the logarithmic scale including effects for 'subjects' and 'treatment'.|The dispersion value standard error of the mean is actually intra individual geometric coefficient of variation (gCV) (%).|||40.234|23.260|
72477709|NCT03143166|144481388|OTHER||Adjusted gMean ratio Test/Reference (%)|30.61|STANDARD_ERROR_OF_MEAN|74.9|||TWO_SIDED|90.0|23.404|40.037|||ANOVA|An analysis of variance (ANOVA) was used on the logarithmic scale including effects for 'subjects' and 'treatment'.|The dispersion value standard error of the mean is actually intra individual geometric coefficient of variation (gCV) (%).|||40.037|23.404|
72477710|NCT00715962|144481425|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Fisher Exact|Fisher's exact test used as the rate of falling was low.||||||<.05
72477711|NCT00715962|144481426|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||ANCOVA|||||||<.05
72477712|NCT01850446|144481464|NON_INFERIORITY|Non-inferiority margin was prespecified as 20% (on each day). Type I error (alpha) level of 0.025 was prospectively planned for this analysis. Power of this analysis was planned to be greater than 0.8|Z-value|8.56|||<|0.0001|TWO_SIDED|||||Global test statistics (GTS) was constructed in accordance with O'Brien Procedures for Comparing Samples with Multiple Endpoints.|Z-test for Global test statistics|||Individual day analyses were combined into Global Test Statistics (patient diary analysis)||||<0.0001
72477713|NCT01850446|144481464|NON_INFERIORITY|Non-inferiority margin was prespecified as 20% (on each day). Type I error (alpha) level of 0.025 was prospectievely planned for this analysis. Power of this analysis was planned to be greater than 0.8|Z-value|7.31|||<|0.0001|TWO_SIDED|||||Global test statistics (GTS) was constructed in accordance with O'Brien, P. (1984). Procedures for Comparing Samples with Multiple Endpoints. Biometrics, 40(4), 1079-1087. doi:10.2307/2531158|Z-test for Global test statistics|||Individual day analyses were combined into Global Test Statistics (physician's examination analysis)||||<0.0001
72477714|NCT01850446|144481465|NON_INFERIORITY|Non-inferiority margin was prespecified as 1.2 degree\*day|Mean Difference (Final Values)|0.44||||0.027|ONE_SIDED|97.5|-0.23||||t-test, 1 sided|||Severity of fever was measured as area under curve (body temperature-time)|||-0.23|0.027
72477715|NCT01850446|144481466|NON_INFERIORITY|Non-inferiority magrin was prespecified as 20% of comparator duration|Mean Difference (Final Values)|0.23||||0.02|ONE_SIDED|97.5||0.63|||t-test, 1 sided|mean survival time estimates obtained from survival analysis were compared by means of t-test with infinite degrees of freedom||||0.63||0.02
72477716|NCT01850446|144481467|NON_INFERIORITY|Non-inferiority margin was prespecified as 20% (on each day)|Z-value|6.95|||<|0.0001|TWO_SIDED|||||Global test statistics (GTS) was constructed in accordance with O'Brien, P. (1984). Procedures for Comparing Samples with Multiple Endpoints. Biometrics, 40(4), 1079-1087. doi:10.2307/2531158|Z-test for Global test statistics|||Individual day analyses were combined into Global Test Statistics||||<0.0001
72477717|NCT01850446|144481468|NON_INFERIORITY|N.I. margin was prespecified as 20% of comparator (with respect to timeframe)|Mean Difference (Final Values)|-0.49|||<|0.001|ONE_SIDED|97.5||1.33|||t-test, 1 sided|||Severity of influenza symptoms (day1 morning)||1.33||<0.001
72477718|NCT01850446|144481468|NON_INFERIORITY|N.I. margin was prespecified as 20% of comparator (with respect to timeframe)|Mean Difference (Final Values)|0.56||||0.013|ONE_SIDED|97.5||2.59|||t-test, 1 sided|||Severity of influenza symptoms (day2 morning)||2.59||0.013
72477719|NCT01850446|144481468|NON_INFERIORITY|N.I. margin was prespecified as 20% of comparator (with respect to timeframe)|Mean Difference (Final Values)|0.82||||0.084|ONE_SIDED|97.5||2.66|||t-test, 1 sided|||Severity of influenza symptoms (day3 morning)||2.66||0.084
72477720|NCT01850446|144481468|NON_INFERIORITY|N.I. margin was prespecified as 20% of comparator (with respect to timeframe)|Mean Difference (Final Values)|0.62||||0.22|ONE_SIDED|97.5||2.2|||t-test, 1 sided|||Severity of influenza symptoms (day4 morning)||2.2||0.22
72477721|NCT01850446|144481468|NON_INFERIORITY|N.I. margin was prespecified as 20% of comparator (with respect to timeframe)|Mean Difference (Final Values)|-0.27||||0.04|ONE_SIDED|97.5||1.07|||t-test, 1 sided|||Severity of influenza symptoms (day5 morning)||1.07||0.04
72477722|NCT01850446|144481468|NON_INFERIORITY|N.I. margin was prespecified as 20% of comparator (with respect to timeframe)|Mean Difference (Final Values)|-0.08||||0.13|ONE_SIDED|97.5||0.98|||t-test, 1 sided|||Severity of influenza symptoms (day6 morning)||0.98||0.13
72477723|NCT01850446|144481468|NON_INFERIORITY|N.I. margin was prespecified as 20% of comparator (with respect to timeframe)|Mean Difference (Final Values)|-0.25||||0.135|ONE_SIDED|97.5||0.74|||t-test, 1 sided|||severity of influenza symptoms (day1 morning)||0.74||0.135
72477724|NCT01850446|144481468|NON_INFERIORITY|N.I. margin was prespecified as 20% of comparator (with respect to timeframe)|Mean Difference (Final Values)|0.64||||0.004|ONE_SIDED|97.5||2.67|||t-test, 1 sided|||Severity of influenza symptoms (day1 evening)||2.67||0.004
72477725|NCT01850446|144481468|NON_INFERIORITY|N.I. margin was prespecified as 20% of comparator (with respect to timeframe)|Mean Difference (Final Values)|0.9||||0.05|ONE_SIDED|97.5||2.94|||t-test, 1 sided|||Severity of influenza symptoms (day2 evening)||2.94||0.05
72477726|NCT01850446|144481468|NON_INFERIORITY|N.I. margin was prespecified as 20% of comparator (with respect to timeframe)|Mean Difference (Final Values)|1.34||||0.447|ONE_SIDED|97.5||3.08|||t-test, 1 sided|||Severity of influenza symptoms (day3 evening)||3.08||0.447
72477727|NCT01850446|144481468|NON_INFERIORITY|N.I. margin was prespecified as 20% of comparator (with respect to timeframe)|Mean Difference (Final Values)|-0.08||||0.042|ONE_SIDED|97.5||1.4|||t-test, 1 sided|||Severity of influenza symptoms (day4 evening)||1.4||0.042
72477728|NCT01850446|144481468|NON_INFERIORITY|N.I. margin was prespecified as 20% of comparator (with respect to timeframe)|Mean Difference (Final Values)|0.29||||0.313|ONE_SIDED|97.5||1.53|||t-test, 1 sided|||Severity of influenza symptoms (day5 evening)||1.53||0.313
72477729|NCT01850446|144481468|NON_INFERIORITY|N.I. margin was prespecified as 20% of comparator (with respect to timeframe)|Mean Difference (Final Values)|-0.27||||0.087|ONE_SIDED|97.5||0.77|||t-test, 1 sided|||Severity of influenza symptoms (day6 evening)||0.77||0.087
72477730|NCT01850446|144481468|NON_INFERIORITY|N.I. margin was prespecified as 20% of comparator (with respect to timeframe)|Mean Difference (Final Values)|-0.43|||<|0.001|ONE_SIDED|97.5||1.41|||t-test, 1 sided|||Severity of influenza symptoms (day1 physician's objective examination)||1.41||<0.001
72477731|NCT01850446|144481468|NON_INFERIORITY|N.I. margin was prespecified as 20% of comparator (with respect to timeframe)|Mean Difference (Final Values)|1.34||||0.305|ONE_SIDED|97.5||3.11|||t-test, 1 sided|||Severity of influenza symptoms (day3 physician's objective examination)||3.11||0.305
72477732|NCT01850446|144481469|NON_INFERIORITY|N.I. margin was prespecified as 20% of comparator (with respect to timeframe)|Mean Difference (Final Values)|0.08||||0.02|ONE_SIDED|97.5||0.5|||t-test, 1 sided|||Fever duration||0.5||0.02
72623373|NCT03312543|144777438|SUPERIORITY|Superiority to baseline concluded if the lower bound of the 95% confidence interval for the mean difference is above 0.5.|Mean Difference (Net)|0.47|STANDARD_DEVIATION|0.578|<|0.001|TWO_SIDED|95.0|0.32|0.63|||t-test, 2 sided|||||0.63|0.32|<0.001
72477733|NCT01850446|144481469|NON_INFERIORITY|N.I. margin was prespecified as 20% of comparator (with respect to timeframe)|Mean Difference (Final Values)|-0.18|||<|0.001|ONE_SIDED|97.5||0.14|||t-test, 1 sided|||Non-specific symptoms duration||0.14||<0.001
72477734|NCT01850446|144481469|NON_INFERIORITY|N.I. margin was prespecified as 20% of comparator (with respect to timeframe)|Mean Difference (Final Values)|-0.25|||<|0.001|ONE_SIDED|97.5||0.11|||t-test, 1 sided|||Nasal/ throat/ chest symptoms duration||0.11||<0.001
72477735|NCT01850446|144481470|NON_INFERIORITY|N.I. margin was prespecified as 20% (AUC ratio supposed to be less than 1.2)|AUC ratio|1.04||||0.015|TWO_SIDED|95.0|0.9|1.17||bootstrap (100000 rep) confidence limits were constructed for AUC ratio|one-sample Z-test|AUC ratio was compared with N.I. margin||Severity of influenza was measured as area under curve (symptoms score-time)||1.17|0.9|0.015
72477736|NCT01850446|144481471|NON_INFERIORITY|N.I. margin was prespecified as 20%|Risk Difference (RD)|0.05||||0.036|ONE_SIDED|97.5||0.19|||Z test for proportions|||Percentage difference of Patients, Who Used Antipyretics (day1)||0.19||0.036
72477737|NCT01850446|144481471|NON_INFERIORITY|N.I. margin was prespecified as 20%|Risk Difference (RD)|0.01||||0.009|ONE_SIDED|97.5||0.15|||Z test for proportions|||Percentage difference of Patients, Who Used Antipyretics (day2)||0.15||0.009
72508825|NCT02749721|144548167|OTHER||Pearson's R|0.249||||0.371|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P3b (latency) and QIDS-SR baseline scores||||0.371
72508826|NCT02749721|144548167|OTHER||Pearson's R|-0.072||||0.764|TWO_SIDED||||||Pearson's correlation|||Correlation between VGNG P200 (latency) and QIDS-SR baseline scores||||0.764
72477738|NCT01850446|144481471|NON_INFERIORITY|N.I. margin was prespecified as 20%|Risk Difference (RD)|0.03|||<|0.001|ONE_SIDED|97.5||0.13|||Z test for proportions|||Percentage difference of Patients, Who Used Antipyretics (day3)||0.13||<0.001
72477739|NCT01850446|144481471|NON_INFERIORITY|N.I. margin was prespecified as 20%|Risk Difference (RD)|-0.02|||<|0.001|ONE_SIDED|97.5||0.13|||Z test for proportions|||Percentage difference of Patients, Who Used Antipyretics (day4)||0.13||<0.001
72477740|NCT01850446|144481471|NON_INFERIORITY|N.I. margin was prespecified as 20%|Risk Difference (RD)|-0.02|||<|0.001|ONE_SIDED|97.5||0.01|||Z test for proportions|||Percentage difference of Patients, Who Used Antipyretics (day5)||0.01||<0.001
72477741|NCT01850446|144481472|NON_INFERIORITY|N.I. margin was prespecified as 20%|Risk Difference (RD)|0.0|||<|0.001|ONE_SIDED|97.5||0.03|||Z test for proportions|||Percentage of Patients Requiring Antibiotics Administration||0.03||<0.001
72477742|NCT01850446|144481473|NON_INFERIORITY|N.I. margin was prespecified as 20%|Risk Difference (RD)|-0.01||||0.014|ONE_SIDED|97.5||0.15|||Z test for proportions|||Proportion difference of Patients With Negative Results (day3)||0.15||0.014
72477743|NCT01850446|144481473|NON_INFERIORITY|N.I. margin was prespecified as 20%|Risk Difference (RD)|-0.08||||0.037|ONE_SIDED|97.5||0.03|||Z test for proportions|||Proportion difference of Patients With Negative Results (day5)||0.03||0.037
72477744|NCT01850446|144481473|NON_INFERIORITY|N.I. margin was prespecified as 20%|Risk Difference (RD)|-0.03|||<|0.001|ONE_SIDED|97.5||0.03|||Z test for proportions|||Proportion difference of Patients With Negative Results (day7)||0.03||<0.001
72477745|NCT01850446|144481474|SUPERIORITY||Mean Difference (Final Values)|1.89||||0.03|TWO_SIDED|95.0|0.19|3.59||P-value IL2 provided for between-group comparisson of difference from days 3 to day 1.|t-test, 2 sided|||difference between changes from day 1 to day 3 (IL-2)||3.59|0.19|0.03
72477746|NCT01850446|144481474|SUPERIORITY||Mean Difference (Final Values)|1.23||||0.19|TWO_SIDED|95.0|-0.64|3.12||P-value IL2 provided for between-group comparisson of difference from day 7 to day 1.|t-test, 2 sided|||difference between changes from day 1 to day 7 (IL-2)||3.12|-0.64|0.19
72477747|NCT01850446|144481474|SUPERIORITY|||||||0.012|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 3 (IFN-γ)||||0.012
72477748|NCT01850446|144481474|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 7 (IFN-γ)||||<0.0001
72477749|NCT01850446|144481474|SUPERIORITY|||||||0.795|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 3 (IL-18)||||0.795
72477750|NCT01850446|144481474|SUPERIORITY|||||||0.992|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 7 (IL-18)||||0.992
72477751|NCT01850446|144481474|SUPERIORITY||Mean Difference (Final Values)|0.47||||0.04|TWO_SIDED|95.0|0.02|0.92|||t-test, 2 sided|||difference between changes from day 1 to day 3 (IL-4)||0.92|0.02|0.04
72477752|NCT01850446|144481474|SUPERIORITY||Median Difference (Final Values)|0.37||||0.08|TWO_SIDED|95.0|-0.04|0.79|||t-test, 2 sided|||difference between changes from day 1 to day 7 (IL-4)||0.79|-0.04|0.08
72477753|NCT01850446|144481474|SUPERIORITY|||||||0.062|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 3 (IL-16)||||0.062
72477754|NCT01850446|144481474|SUPERIORITY|||||||0.638|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 7 (IL-16)||||0.638
72477755|NCT01850446|144481475|SUPERIORITY|||||||0.065|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 3 (Spontaneous IFN-α)||||0.065
72477756|NCT01850446|144481475|SUPERIORITY|||||||0.404|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 3 (Spontaneous IFN-α)||||0.404
72477757|NCT01850446|144481475|SUPERIORITY|||||||0.204|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 3 (Induced IFN-α)||||0.204
72477758|NCT01850446|144481475|SUPERIORITY|||||||0.386|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 7 (Induced IFN-α)||||0.386
72477759|NCT01850446|144481475|SUPERIORITY|||||||0.592|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 3 (Spontaneous IFN-γ)||||0.592
72477760|NCT01850446|144481475|SUPERIORITY|||||||0.356|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 7 (Spontaneous IFN-γ)||||0.356
72477761|NCT01850446|144481475|SUPERIORITY|||||||0.475|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 3 (Induced IFN-γ)||||0.475
72477762|NCT01850446|144481475|SUPERIORITY||||||>|0.99|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 7 (Induced IFN-γ)||||>0.99
72477763|NCT01850446|144481476|SUPERIORITY|||||||0.364|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 3 (leukocytes)||||0.364
72477764|NCT01850446|144481476|SUPERIORITY|||||||0.07|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 7 (leukocytes)||||0.07
72477765|NCT01850446|144481476|SUPERIORITY|||||||0.607|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day1 to day 3 (neutrophils)||||0.607
72477766|NCT01850446|144481476|SUPERIORITY|||||||0.028|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 7 (neutrophils)||||0.028
72477767|NCT01850446|144481476|SUPERIORITY|||||||0.759|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 3 (lymphocytes)||||0.759
72477768|NCT01850446|144481476|SUPERIORITY|||||||0.777|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 7 (lymphocytes)||||0.777
72477769|NCT01850446|144481476|SUPERIORITY|||||||0.02|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 3 (monocytes)||||0.02
72477770|NCT01850446|144481476|SUPERIORITY|||||||0.343|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 7 (lymphocytes)||||0.343
72477771|NCT01850446|144481476|SUPERIORITY|||||||0.575|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 3 (eosinophils)||||0.575
72477772|NCT01850446|144481476|SUPERIORITY|||||||0.912|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 7 (eosinophils)||||0.912
72477773|NCT01850446|144481476|SUPERIORITY|||||||0.242|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 3 (basophils)||||0.242
72477774|NCT01850446|144481476|SUPERIORITY|||||||0.102|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 7 (basophils)||||0.102
72477775|NCT01850446|144481476|SUPERIORITY|||||||0.429|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 3 (CD3+)||||0.429
72477776|NCT01850446|144481476|SUPERIORITY|||||||0.783|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 7 (CD3+)||||0.783
72477777|NCT01850446|144481476|SUPERIORITY|||||||0.466|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 3 (CD3+CD4+)||||0.466
72477778|NCT01850446|144481476|SUPERIORITY|||||||0.945|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 7 (CD3+CD4+)||||0.945
72477779|NCT01850446|144481476|SUPERIORITY|||||||0.335|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 3 (CD3+CD8+)||||0.335
72477780|NCT01850446|144481476|SUPERIORITY|||||||0.66|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 7 (CD3+CD8+)||||0.66
72477781|NCT01850446|144481476|SUPERIORITY|||||||0.01|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 3 (CD3+CD16+CD56+)||||0.01
72477782|NCT01850446|144481476|SUPERIORITY|||||||0.573|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 7 (CD3+CD16+CD56+)||||0.573
72477783|NCT01850446|144481476|SUPERIORITY|||||||0.472|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 3 (CD3-CD16+CD56+)||||0.472
72477784|NCT01850446|144481476|SUPERIORITY|||||||0.69|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 7 (CD3-CD16+CD56+)||||0.69
72477785|NCT01850446|144481476|SUPERIORITY|||||||0.727|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 3 (CD3-CD8+)||||0.727
72477786|NCT01850446|144481476|SUPERIORITY|||||||0.554|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 7 (CD3-CD8+)||||0.554
72477787|NCT01850446|144481476|SUPERIORITY|||||||0.837|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 3 (CD19+CD3-)||||0.837
72399783|NCT01955161|144307190|SUPERIORITY||Mean Difference (Final Values)|0.33|STANDARD_ERROR_OF_MEAN|0.47||0.9591|TWO_SIDED|95.0|-0.59|1.26||Corrected for multiplicity|Mixed Models Analysis|Treatment, country, MMSE stratum, week as fixed effects, baseline score, treatment-by-week, MMSE stratum-by-week, and baseline-by-week interactions|A negative mean difference indicates a treatment effect in favour of idalopirdine|For demonstrating efficacy of a dose, change in cognition (ADAS-cog) and either change in daily functioning (ADCS-ADL23) or change in global clinical impression (ADCS-CGIC) had to show statistically significant favourable differences compared to placebo at Week 24. Multiple testing procedures were used to control the overall type 1 error at 5%. The null hypothesis of no difference in mean change from baseline in ADAS-cog total score at Week 24 was tested for each dose at significance level 2.5%.||1.26|-0.59|0.9591
72399784|NCT01955161|144307190|SUPERIORITY||Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.47||1|TWO_SIDED|95.0|-0.88|0.98||Corrected for multiplicity according to the multiple testing procedure|Mixed Models Analysis|Treatment, country, MMSE stratum, week as fixed effects, baseline score, treatment-by-week, MMSE stratum-by-week, and baseline-by-week interactions|A negative mean difference indicates a treatment effect in favour of idalopirdine.|For demonstrating efficacy of a dose, change in cognition (ADAS-cog) and either change in daily functioning (ADCS-ADL23) or change in global clinical impression (ADCS-CGIC) had to show statistically significant favourable differences compared to placebo at Week 24. Multiple testing procedures were used to control the overall type 1 error at 5%. The null hypothesis of no difference in mean change from baseline in ADAS-cog total score at Week 24 was tested for each dose at significance level 2.5%.||0.98|-0.88|1.000
72399785|NCT01955161|144307191|SUPERIORITY||Mean Difference (Final Values)|-0.08|STANDARD_ERROR_OF_MEAN|0.66||1|TWO_SIDED|95.0|-1.37|1.21||Corrected for multiplicity according toe the multiple testing procedure|Mixed Models Analysis|Treatment, country, MMSE stratum, week as fixed effects, baseline score, treatment-by-week, MMSE stratum-by-week, and baseline-by-week interactions|A positive mean difference indicates a treatment effect in favour of idalopirdine.|For demonstrating efficacy of a dose, change in cognition (ADAS-cog) and either change in daily functioning (ADCS-ADL23) or change in global clinical impression (ADCS-CGIC) had to show statistically significant favourable differences compared to placebo at Week 24. Multiple testing procedures were used to control the overall type 1 error at 5%. The null hypothesis of no difference in mean change from baseline in ADAS-cog total score at Week 24 was tested for each dose at significance level 2.5%.||1.21|-1.37|1.000
72477788|NCT01850446|144481476|SUPERIORITY|||||||0.967|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 7 (CD19+CD3-)||||0.967
72477789|NCT01850446|144481476|SUPERIORITY|||||||0.473|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 3 (CD3+CD119+)||||0.473
72477790|NCT01850446|144481476|SUPERIORITY|||||||0.736|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 7 (CD3+CD119+)||||0.736
72477791|NCT01850446|144481477|SUPERIORITY|||||||0.282|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 3 (RC of neutrophils)||||0.282
72477792|NCT01850446|144481477|SUPERIORITY|||||||0.071|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 7 (RC of neutrophils)||||0.071
72477793|NCT01850446|144481477|SUPERIORITY|||||||0.45|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 3 (RC of lymphocytes)||||0.45
72477794|NCT01850446|144481477|SUPERIORITY|||||||0.58|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 7 (RC of lymphocytes)||||0.58
72477795|NCT01850446|144481477|SUPERIORITY|||||||0.017|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 3 (RC of monocytes)||||0.017
72477796|NCT01850446|144481477|SUPERIORITY|||||||0.019|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 7 (RC of monocytes)||||0.019
72508827|NCT02749721|144548167|OTHER||Pearson's R|-0.225||||0.34|TWO_SIDED||||||Pearson's correlation|||Correlation between VGNG P3a (latency) and QIDS-SR baseline scores||||0.34
72508828|NCT02749721|144548167|OTHER||Pearson's R|0.148||||0.57|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P200 (latency) and QIDS-SR baseline to endpoint percent change||||0.570
72508829|NCT02749721|144548167|OTHER||Pearson's R|0.228||||0.434|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P3a (latency) and QIDS-SR baseline to endpoint percent change||||0.434
72477797|NCT01850446|144481477|SUPERIORITY|||||||0.424|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 3 (RC of eosinophils)||||0.424
72477798|NCT01850446|144481477|SUPERIORITY|||||||0.666|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 7 (RC of eosinophils)||||0.666
72477799|NCT01850446|144481477|SUPERIORITY|||||||0.268|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 3 (RC of basophils)||||0.268
72508830|NCT02749721|144548167|OTHER||Pearson's R|0.22||||0.569|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P3b (latency) and QIDS-SR baseline to endpoint percent change||||0.569
72508831|NCT02749721|144548167|OTHER||Pearson's R|0.645||||0.005|TWO_SIDED||||||Pearson's correlation|||Correlation between VGNG P200 (latency) and QIDS-SR baseline to endpoint percent change||||0.005
72508832|NCT02749721|144548167|OTHER||Pearson's R|0.105||||0.698|TWO_SIDED||||||Pearson's correlation|||Correlation between VGNG P3a (latency) and QIDS-SR baseline to endpoint percent change||||0.698
72508833|NCT02749721|144548167|OTHER||Pearson's R|-0.073||||0.774|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P200 (latency) and PDQ baseline scores||||0.774
72508834|NCT02749721|144548167|OTHER||Pearson's R|0.577||||0.024|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P3a (latency) and PDQ baseline score||||0.024
72508835|NCT02749721|144548167|OTHER||Pearson's R|0.146||||0.603|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P3b (latency) and PDQ baseline scores||||0.603
72508836|NCT02749721|144548167|OTHER||Pearson's R|-0.232||||0.326|TWO_SIDED||||||Pearson's correlation|||Correlation between VGNG P200 (latency) and PDQ baseline scores||||0.326
72477800|NCT01850446|144481477|SUPERIORITY|||||||0.031|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 7 (RC of basophils)||||0.031
72477801|NCT01850446|144481477|SUPERIORITY|||||||0.361|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 3 (RC of CD3+)||||0.361
72477802|NCT01850446|144481477|SUPERIORITY|||||||0.699|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 7 (RC of CD3+)||||0.699
72477803|NCT01850446|144481477|SUPERIORITY|||||||0.418|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 3 (RC of CD3+CD4+)||||0.418
72399786|NCT01955161|144307191|SUPERIORITY||Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.66||1|TWO_SIDED|95.0|-1.29|1.31||Corrected for multiplicity according to the multiple testing procedure|Mixed Models Analysis|Treatment, country, MMSE stratum, week as fixed effects, baseline score, treatment-by-week, MMSE stratum-by-week, and baseline-by-week interactions|A positive mean difference indicates a treatment effect in favour of idalopirdine.|For demonstrating efficacy of a dose, change in cognition (ADAS-cog) and either change in daily functioning (ADCS-ADL23) or change in global clinical impression (ADCS-CGIC) had to show statistically significant favourable differences compared to placebo at Week 24. Multiple testing procedures were used to control the overall type 1 error at 5%. The null hypothesis of no difference in mean change from baseline in ADAS-cog total score at Week 24 was tested for each dose at significance level 2.5%.||1.31|-1.29|1.000
72399787|NCT01955161|144307192|SUPERIORITY||Mean Difference (Final Values)|0.03|STANDARD_ERROR_OF_MEAN|0.09||1|TWO_SIDED|95.0|-0.15|0.2||Corrected for multiplicity according to the multiple testing procedure|Mixed Models Analysis|Treatment, country, MMSE stratum, week as fixed effects, baseline score, treatment-by-week, MMSE stratum-by-week, and baseline-by-week interactions|A negative mean difference indicates a treatment effect in favour of idalopirdine.|For demonstrating efficacy of a dose, change in cognition (ADAS-cog) and either change in daily functioning (ADCS-ADL23) or change in global clinical impression (ADCS-CGIC) had to show statistically significant favourable differences compared to placebo at Week 24. Multiple testing procedures were used to control the overall type 1 error at 5%. The null hypothesis of no difference in mean change from baseline in ADAS-cog total score at Week 24 was tested for each dose at significance level 2.5%.||0.20|-0.15|1.000
72399788|NCT01955161|144307192|SUPERIORITY||Mean Difference (Final Values)|-0.16|STANDARD_ERROR_OF_MEAN|0.09||1|TWO_SIDED|95.0|-0.34|0.02||Corrected for multiplicity according to the multiple testing procedure|Mixed Models Analysis|Treatment, country, MMSE stratum, week as fixed effects, baseline score, treatment-by-week, MMSE stratum-by-week, and baseline-by-week interactions|A negative mean difference indicates a treatment effect in favour of idalopirdine.|For demonstrating efficacy of a dose, ADAS-cog total score and either ADCS-ADL23 total score or ADCS CGIC had to show statistically significant favourable differences compared to placebo at Week 24. Multiple testing procedures were used to control the overall type 1 error at 5%. The null hypothesis of no difference in mean change from baseline in ADAS-cog total score at Week 24 was tested for each dose at significance level 2.5%.||0.02|-0.34|1.000
72399789|NCT01245270|144307201|SUPERIORITY_OR_OTHER_LEGACY|||||||0.003||95.0||||"For the incremental area under the curve (AUCi), only the extent of interpolated values above baseline contributed.~Values obtained following the control and extract capsules were compared by paired t-tests."|t-test, 2 sided|||||||0.003
72399790|NCT01245270|144307202|SUPERIORITY_OR_OTHER_LEGACY|||||||0.028||95.0||||For incremental area under the curve (AUCi), only the extent of interpolated values above baseline contributed. Values obtained following the control and extract capsules were compared by paired t-tests.|t-test, 2 sided|||||||0.028
72399791|NCT01277523|144307211|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.111|STANDARD_ERROR_OF_MEAN|0.055||0.0457|TWO_SIDED|95.0|0.002|0.22||Stepwise testing of the null hypothesis was used to test the efficacy of Tio R5 and then Tio R2.5, each over placebo.|Mixed Models Analysis||Difference calculated as Tio R2.5 minus placebo|||0.220|0.002|0.0457
72477804|NCT01850446|144481477|SUPERIORITY||||||>|0.99|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 7 (RC of CD3+CD4+)||||>0.99
72477805|NCT01850446|144481477|SUPERIORITY|||||||0.172|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 3 (RC of CD3+CD8+)||||0.172
72623374|NCT03312543|144777438|EQUIVALENCE|The null hypothesis was that the change from baseline to Week 12 was equal for the active cell and the sham cell. The alternative hypothesis was that the mean change from Baseline was not equal between the two cells.|Mean Difference (Net)|0.11|STANDARD_ERROR_OF_MEAN|0.094||0.224|TWO_SIDED|95.0|-0.07|0.3|||ANCOVA|With treatment and skin type group as factors and the corresponding averaged baseline score as a covariate.||||0.30|-0.07|0.224
72399792|NCT01277523|144307211|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.09|STANDARD_ERROR_OF_MEAN|0.055||0.1039|TWO_SIDED|95.0|-0.019|0.198||Stepwise testing of the null hypothesis was used to test the efficacy of Tio R5 and then Tio R2.5, each over placebo.|Mixed Models Analysis||Difference calculated as Tio R5 minus placebo|||0.198|-0.019|0.1039
72399793|NCT01277523|144307212|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.115|STANDARD_ERROR_OF_MEAN|0.059||0.0509|TWO_SIDED|95.0|0.0|0.231||Stepwise testing of the null hypothesis was used to test the efficacy of Tio R5 and then Tio R2.5, each over placebo.|Mixed Models Analysis||Difference calculated as Tio R2.5 minus placebo|||0.231|-0.000|0.0509
72477806|NCT01850446|144481477|SUPERIORITY|||||||0.904|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 7 (RC of CD3+CD8+)||||0.904
72477807|NCT01850446|144481477|SUPERIORITY|||||||0.148|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 3 (RC of CD3+CD16+CD56+)||||0.148
72477808|NCT01850446|144481477|SUPERIORITY|||||||0.821|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 7 (RC of CD3+CD16+CD56+)||||0.821
72477809|NCT01850446|144481477|SUPERIORITY|||||||0.31|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 3 (RC of CD3-CD16+CD56+)||||0.31
72477810|NCT01850446|144481477|SUPERIORITY||||||>|0.99|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 7 (RC of CD3-CD16+CD56+)||||>0.99
72477811|NCT01850446|144481477|SUPERIORITY|||||||0.43|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 3 (RC of CD3-CD8+)||||0.43
72477812|NCT01850446|144481477|SUPERIORITY|||||||0.821|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 7 (RC of CD3-CD8+)||||0.821
72477813|NCT01850446|144481477|SUPERIORITY|||||||0.943|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 3 (RC of CD19+CD3-)||||0.943
72477814|NCT01850446|144481477|SUPERIORITY|||||||0.841|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 7 (RC of CD19+CD3-)||||0.841
72477815|NCT00759915|144481478|NON_INFERIORITY_OR_EQUIVALENCE|The 90% confidence intervals for the ratios (test/reference) of the least squares means of the non-transformed parameters Cmax, AUClast, AUCinf, Tmax, λz, and T1/2, were calculated.|mean ratio|109.98||||||90.0|100.1|120.8|||ANOVA|log-transformation||||120.8|100.1|
72623375|NCT05535972|144777487|OTHER||Least Square Mean|-6.81|STANDARD_ERROR_OF_MEAN|0.241|||TWO_SIDED|95.0|-7.28|-6.33|||||CFB in CAT score was analyzed using Mixed Model Repeated Measures(MMRM) model with covariates of smoking status, CAT score at Baseline, visit, interaction of CAT score at Baseline\*visit. Estimates derived from inverse probability weighted MMRM model.|||-6.33|-7.28|
72399794|NCT01277523|144307212|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.054|STANDARD_ERROR_OF_MEAN|0.058||0.3605|TWO_SIDED|95.0|-0.061|0.168||Stepwise testing of the null hypothesis was used to test the efficacy of Tio R5 and then Tio R2.5, each over placebo.|Mixed Models Analysis||Difference calculated as Tio R5 minus placebo|||0.168|-0.061|0.3605
72399795|NCT01277523|144307213|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.091|STANDARD_ERROR_OF_MEAN|0.059||0.1264|TWO_SIDED|95.0|-0.026|0.207|||Mixed Models Analysis||Difference calculated as Tio R2.5 minus placebo|||0.207|-0.026|0.1264
72399796|NCT01277523|144307213|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.063|STANDARD_ERROR_OF_MEAN|0.059||0.2845|TWO_SIDED|95.0|-0.053|0.179|||Mixed Models Analysis||Difference calculated as Tio R5 minus placebo|||0.179|-0.053|0.2845
72399797|NCT01277523|144307214|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.113|STANDARD_ERROR_OF_MEAN|0.053||0.0338|TWO_SIDED|95.0|0.009|0.217|||Mixed Models Analysis||Difference calculated as Tio R2.5 minus placebo|||0.217|0.009|0.0338
72566400|NCT02697773|144663267|SUPERIORITY||Odds Ratio (OR)|1.96||||0.0005|TWO_SIDED|95.0|1.34|2.87|||Regression, Logistic|||Week 16 \>=50%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.87|1.34|0.0005
72566401|NCT02697773|144663267|SUPERIORITY||Odds Ratio (OR)|1.69||||0.0141|TWO_SIDED|95.0|1.11|2.56|||Regression, Logistic|||Week 16, \>=70%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.56|1.11|0.0141
72566402|NCT02697773|144663267|SUPERIORITY||Odds Ratio (OR)|1.9||||0.0022|TWO_SIDED|95.0|1.26|2.87|||Regression, Logistic|||Week 16, \>=70%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.87|1.26|0.0022
72566403|NCT02697773|144663267|SUPERIORITY||Odds Ratio (OR)|1.42||||0.2286|TWO_SIDED|95.0|0.8|2.5|||Regression, Logistic|||Week 16, \>=90%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.50|0.80|0.2286
72566404|NCT02697773|144663267|SUPERIORITY||Odds Ratio (OR)|1.47||||0.1808|TWO_SIDED|95.0|0.84|2.57|||Regression, Logistic|||Week 16, \>=90%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.57|0.84|0.1808
72566405|NCT02697773|144663267|SUPERIORITY||Odds Ratio (OR)|2.3|||<|0.0001|TWO_SIDED|95.0|1.57|3.36|||Regression, Logistic|||Week 16, \>=50%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.36|1.57|<.0001
72566406|NCT02697773|144663269|SUPERIORITY||Odds Ratio (OR)|1.44||||0.1463|TWO_SIDED|95.0|0.88|2.34|||Regression, Logistic|||Week 2: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline PGA of osteoarthritis, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.34|0.88|0.1463
72399798|NCT01277523|144307214|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.087|STANDARD_ERROR_OF_MEAN|0.053||0.0999|TWO_SIDED|95.0|-0.017|0.191|||Mixed Models Analysis||Difference calculated as Tio R5 minus placebo|||0.191|-0.017|0.0999
72566407|NCT02697773|144663269|SUPERIORITY||Odds Ratio (OR)|0.99||||0.9644|TWO_SIDED|95.0|0.6|1.62|||Regression, Logistic|||Week 2: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline PGA of osteoarthritis, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||1.62|0.60|0.9644
72566408|NCT02697773|144663269|SUPERIORITY||Odds Ratio (OR)|1.62||||0.0422|TWO_SIDED|95.0|1.02|2.59|||Regression, Logistic|||Week 4: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline PGA of osteoarthritis, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.59|1.02|0.0422
72566409|NCT02697773|144663269|SUPERIORITY||Odds Ratio (OR)|1.36||||0.1995|TWO_SIDED|95.0|0.85|2.16|||Regression, Logistic|||Week 4: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline PGA of osteoarthritis, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.16|0.85|0.1995
72399799|NCT01277523|144307215|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.087|STANDARD_ERROR_OF_MEAN|0.057||0.1252|TWO_SIDED|95.0|-0.024|0.198|||Mixed Models Analysis||Difference calculated as Tio R2.5 minus placebo|||0.198|-0.024|0.1252
72399800|NCT01277523|144307215|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.052|STANDARD_ERROR_OF_MEAN|0.056||0.3549|TWO_SIDED|95.0|-0.058|0.163|||Mixed Models Analysis||Difference calculated as Tio R5 minus placebo|||0.163|-0.058|0.3549
72399801|NCT01277523|144307216|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.118|STANDARD_ERROR_OF_MEAN|0.088||0.1819|TWO_SIDED|95.0|-0.055|0.292|||Mixed Models Analysis||Difference calculated as Tio R2.5 minus placebo|||0.292|-0.055|0.1819
72399802|NCT01277523|144307216|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.053|STANDARD_ERROR_OF_MEAN|0.088||0.5448|TWO_SIDED|95.0|-0.119|0.226|||Mixed Models Analysis||Difference calculated as Tio R5 minus placebo|||0.226|-0.119|0.5448
72399803|NCT01277523|144307218|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.058|STANDARD_ERROR_OF_MEAN|0.082||0.4762|TWO_SIDED|95.0|-0.102|0.219|||Mixed Models Analysis||Difference calculated as Tio R2.5 minus placebo|||0.219|-0.102|0.4762
72399804|NCT01277523|144307218|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.036|STANDARD_ERROR_OF_MEAN|0.081||0.6558|TWO_SIDED|95.0|-0.123|0.196|||Mixed Models Analysis||Difference calculated as Tio R5 minus placebo|||0.196|-0.123|0.6558
72399805|NCT01277523|144307220|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.001|STANDARD_ERROR_OF_MEAN|0.153||0.996|TWO_SIDED|95.0|-0.301|0.3|||Mixed Models Analysis|||||0.300|-0.301|0.9960
72399806|NCT01277523|144307220|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.058|STANDARD_ERROR_OF_MEAN|0.151||0.703|TWO_SIDED|95.0|-0.355|0.239|||Mixed Models Analysis|||||0.239|-0.355|0.7030
72399807|NCT01277523|144307221|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.032|STANDARD_ERROR_OF_MEAN|0.094||0.7309|TWO_SIDED|95.0|-0.217|0.153|||Mixed Models Analysis|||||0.153|-0.217|0.7309
72399808|NCT01277523|144307221|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.049|STANDARD_ERROR_OF_MEAN|0.093||0.5954|TWO_SIDED|95.0|-0.232|0.133|||Mixed Models Analysis|||||0.133|-0.232|0.5954
72399809|NCT01277523|144307222|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.089|STANDARD_ERROR_OF_MEAN|0.083||0.2841|TWO_SIDED|95.0|-0.074|0.252|||Mixed Models Analysis|||||0.252|-0.074|0.2841
72399810|NCT01277523|144307222|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.021|STANDARD_ERROR_OF_MEAN|0.082||0.795|TWO_SIDED|95.0|-0.14|0.182|||Mixed Models Analysis|||||0.182|-0.140|0.7950
72477816|NCT00759915|144481480|NON_INFERIORITY_OR_EQUIVALENCE|The 90% confidence intervals for the ratios (test/reference) of the least squares means of the non-transformed parameters Cmax, AUClast, AUCinf, Tmax, λz, and T1/2, were calculated.|mean ratio|100.91||||||90.0|96.96|105.0|||ANOVA|log-transformation||||105.0|96.96|
72477817|NCT00759915|144481481|NON_INFERIORITY_OR_EQUIVALENCE|The 90% confidence intervals for the ratios (test/reference) of the least squares means of the non-transformed parameters Cmax, AUClast, AUCinf, Tmax, λz, and T1/2, were calculated.|mean ratio|96.5||||||90.0|92.3|100.97|||ANOVA|log-transformation||||100.97|92.3|
72508837|NCT02749721|144548167|OTHER||Pearson's R|0.098||||0.68|TWO_SIDED||||||Pearson's correlation|||Correlation between VGNG P3a (latency) and PDQ baseline scores||||0.68
72623376|NCT04197583|144777503|OTHER||Proportion by group|0.984|||||TWO_SIDED|95.0|0.948|0.995|||||For Tria subjects with stone management indication only|||0.995|0.948|
72477818|NCT03241225|144481491|SUPERIORITY||Mean Difference (Final Values)|3.59||||0.16|TWO_SIDED|95.0|-1.43|8.61|||t-test, 2 sided||Mean change in EM/PROTECT group not significantly different from mean change in EM/MH group, at week 12.|Week 12||8.61|-1.43|0.16
72477819|NCT03241225|144481492|SUPERIORITY||Mean Difference (Final Values)|-0.16||||0.79|TWO_SIDED|95.0|-1.37|1.05|||t-test, 2 sided|||Domain #1, Week 12||1.05|-1.37|0.79
72399811|NCT01277523|144307223|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.06||||0.9671|TWO_SIDED|95.0|0.07|16.95|||Regression, Cox|||||16.95|0.07|0.9671
72399812|NCT01277523|144307223|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.06||||0.5557|TWO_SIDED|95.0|0.19|22.7|||Regression, Cox|||||22.70|0.19|0.5557
72399813|NCT01277523|144307224|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.75||||0.3567|TWO_SIDED|95.0|0.41|1.38|||Regression, Cox|||||1.38|0.41|0.3567
72399814|NCT01277523|144307224|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.6||||0.1168|TWO_SIDED|95.0|0.32|1.14|||Regression, Cox|||||1.14|0.32|0.1168
72399815|NCT03928847|144307226|SUPERIORITY|The mean EGCG blood levels were compared among 450 mg, 600 mg, and 750 mg groups.|Mean Difference (Net)|250.0|||||TWO_SIDED|||||||||||||
72399816|NCT03928847|144307227|OTHER|ELISA data from each patient before and after EGCG treatment were compared and analyzed with the use of the Wilcoxon signed-rank test (two-tailed).|||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||||||<0.01
72477820|NCT03241225|144481492|SUPERIORITY||Mean Difference (Final Values)|1.38||||0.19|TWO_SIDED|95.0|-0.7|3.46|||t-test, 2 sided|||Domain #2, Week 12||3.46|-0.70|0.19
72477821|NCT03241225|144481492|SUPERIORITY||Mean Difference (Final Values)|-4.53||||0.37|TWO_SIDED|95.0|-14.99|5.93|||t-test, 2 sided|||Domain #3, Week 12||5.93|-14.99|0.37
72477822|NCT03241225|144481492|SUPERIORITY||Mean Difference (Final Values)|-5.24||||0.026|TWO_SIDED|95.0|-9.75|-0.73|||t-test, 2 sided|||Domain #4, Week 12||-0.73|-9.75|0.026
72508838|NCT02749721|144548167|OTHER||Pearson's R|-0.073||||0.774|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P200 (latency) and PDQ baseline to endpoint percent change||||0.774
72508839|NCT02749721|144548167|OTHER||Pearson's R|0.577||||0.024|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P3a (latency) and PDQ baseline to endpoint percent change||||0.024
72399817|NCT03928847|144307228|OTHER|ELISA data from each patient before and after EGCG treatment were compared and analyzed with the use of the Wilcoxon signed-rank test (two-tailed).|||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||||||<0.01
72399818|NCT03928847|144307229|OTHER||||||<|0.01|||||||Kruskal-Wallis|||||||<0.01
72399819|NCT03928847|144307230|OTHER||||||<|0.01|||||||Kruskal-Wallis|||||||<0.01
72399820|NCT03928847|144307231|OTHER||||||<|0.01|||||||Kruskal-Wallis|||||||<0.01
72399821|NCT01881230|144307232|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.692||||0.0183|TWO_SIDED|95.0|1.089|2.629|||Log Rank|||For stratified analysis, the stratified log-rank test and stratified Cox proportional hazards model were used, where the stratification factor is the disease free interval (\<= 1 year; \> 1 year).||2.629|1.089|0.0183
72399822|NCT01881230|144307232|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.581||||0.0152|TWO_SIDED|95.0|0.373|0.904|||Log Rank|||For stratified analysis, the stratified log-rank test and stratified Cox proportional hazards model were used, where the stratification factor is the disease free interval (\<= 1 year; \> 1 year).||0.904|0.373|0.0152
72399823|NCT01881230|144307232|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.039||||0.8599|TWO_SIDED|95.0|0.676|1.597|||Log Rank|||For stratified analysis, the stratified log-rank test and stratified Cox proportional hazards model were used, where the stratification factor is the disease free interval (\<= 1 year; \> 1 year).||1.597|0.676|0.8599
72477823|NCT03241225|144481492|SUPERIORITY||Mean Difference (Final Values)|-0.62||||0.66|TWO_SIDED|95.0|-3.51|2.27|||t-test, 2 sided|||Domain #5, Week 12||2.27|-3.51|0.66
72477824|NCT03241225|144481493|SUPERIORITY||Mean Difference (Final Values)|0.7||||0.14|TWO_SIDED|95.0|-0.26|1.66|||t-test, 2 sided|||Domain #1, Week 12||1.66|-0.26|0.14
72477825|NCT03241225|144481493|SUPERIORITY||Mean Difference (Final Values)|0.78||||0.047|TWO_SIDED|95.0|0.011|1.55||Domain #2|t-test, 2 sided|||Domain #2, Week 12||1.55|0.011|0.047
72477826|NCT03241225|144481493|SUPERIORITY||Mean Difference (Final Values)|0.65||||0.18|TWO_SIDED|95.0|-0.34|1.64|||t-test, 2 sided|||Domain #3, Week 12||1.64|-0.34|0.18
72399824|NCT01881230|144307235|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.375||||0.1579|TWO_SIDED|95.0|0.882|2.143|||Log Rank|||Hazard ratios and associated two-sided 95% confidence intervals were estimated using stratified Cox proportional hazard model. The stratification factor is the disease free interval (≤ 1 year; \> 1 year).||2.143|0.882|0.1579
72399825|NCT01881230|144307235|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.796||||0.2945|TWO_SIDED|95.0|0.52|1.221|||Log Rank|||Hazard ratios and associated two-sided 95% confidence intervals were estimated using stratified Cox proportional hazard model. The stratification factor is the disease free interval (≤ 1 year; \> 1 year).||1.221|0.520|0.2945
72399826|NCT01881230|144307235|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.101||||0.6691|TWO_SIDED|95.0|0.71|1.708|||Log Rank|||Hazard ratios and associated two-sided 95% confidence intervals were estimated using stratified Cox proportional hazard model. The stratification factor is the disease free interval (≤ 1 year; \> 1 year).||1.708|0.710|0.6691
72399827|NCT02389998|144307277|SUPERIORITY||||||<|0.03|||||||ANCOVA|||||||<0.03
72399828|NCT02389998|144307278|SUPERIORITY|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||||||.001
72477827|NCT00007345|144481508|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED|||||An exact Cochran-Armitage trend test was used to compare the distributions. In view of the large number of tests performed, we only refer to those with P-values \<0.01 as statistically significant, with those for which 0.01 \<P\< 0.05 considered trends.|Cochran-Armitage trend test|||||||<0.01
72477828|NCT02074553|144481513|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|100.5|||||TWO_SIDED|90.0|93.14|108.44|||||The reported values are percentages of geometric least square mean ratio.|Analysis of variance (ANOVA) (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% confidence interval (CI).||108.44|93.14|
72477829|NCT02074553|144481513|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|97.82|||||TWO_SIDED|90.0|90.71|105.48|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.||105.48|90.71|
72623377|NCT00323622|144777534|SUPERIORITY_OR_OTHER||1 - (HR1/HR2)|16.8||||0.08|TWO_SIDED|95.0|-2.5|32.4||The p-value presented is the Wald Chi-square p-value from the Cox regression model.|Regression, Cox|Point estimate of efficacy was adjusted for age, geographical area of residence, bednet use and distance from health center.||The analysis aimed to compare rates of first PFMI (RPFMI) between groups over the Months 21-33 time period. Using RFPMI, a Cox model was used to evaluate vaccine efficacy (VE) allowing for adjustment factors. VE, point estimate of efficacy adjusted for covariates, was calculated as 1 - (minus) \[Hazard Ratio (HR) in Cohort 1 - GSK RTS,S/AS02A Group \[HR1\]) divided by HR in Cohort 1 - Engerix-B/Prevnar-Hiberix Group \[HR2\])\], i. e. 1 - (HR1/HR2).||32.40|-2.50|0.08
72623378|NCT00323622|144777534|SUPERIORITY_OR_OTHER||1 - (HR1/HR2)|11.8||||0.43|TWO_SIDED|95.0|-20.11|35.18||The p-value presented is the Wald Chi-square p-value from the Cox regression model|Regression, Cox|Point estimate of efficacy was adjusted for age, geographical area of residence, bednet use and distance from health center.||The analysis aimed to compare rates of first PFMI (RPFMI) between groups over the Months 33-45 time period. Using RFPMI, a Cox model was used to evaluate vaccine efficacy (VE) allowing for adjustment factors. VE, point estimate of efficacy adjusted for covariates, was calculated as 1 - (minus) \[Hazard Ratio (HR) in Cohort 1 - RTS,S/AS02A Group \[HR1\]) divided by HR in Cohort 1 - Engerix-B/Prevnar-Hiberix Group \[HR2\])\], i. e. 1 - (HR1/HR2).||35.18|-20.11|0.43
72399829|NCT02389998|144307279|SUPERIORITY|||||||0.3|||||||McNemar|||||||0.3
72399830|NCT00706979|144307297|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.2||||0.008|TWO_SIDED|95.0|1.1|1.4|||Regression, Logistic|||A logistic regression model was used to examine the primary hypothesis that NRT-enhanced PQAs would yield a higher rate of any ever-occurring quit attempt.||1.4|1.1|0.008
72477830|NCT02074553|144481513|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|86.66|||||TWO_SIDED|90.0|80.32|93.5|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.||93.5|80.32|
72477831|NCT02074553|144481513|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|88.62|||||TWO_SIDED|90.0|85.15|92.24|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.||92.24|85.15|
72399831|NCT00706979|144307298|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.3||||0.09|TWO_SIDED|95.0|1.0|1.7|||Regression, Logistic|||A logistic regression model was used to examine the secondary hypothesis that NRT-enhanced PQAs would yield a higher rate of 7 days of abstinence at some point during the study.||1.7|1.0|0.09
72399832|NCT00706979|144307299|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.3||||0.004|TWO_SIDED|95.0|1.1|1.5|||Regression, Logistic|||A logistic regression model was used to examine the primary hypothesis that NRT-enhanced PQAs would yield a higher rate for the primary outcome of any 24hr quit attempt.||1.5|1.1|0.004
72399833|NCT00706979|144307300|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.2||||0.3|TWO_SIDED|95.0|0.9|1.6|||Regression, Logistic|||A logistic regression model was used to examine the secondary hypothesis that NRT-enhanced PQAs would yield a higher rate for 7 days of abstinence at the six month follow-up.||1.6|0.9|0.3
72508840|NCT02749721|144548167|OTHER||Pearson's R|0.146||||0.603|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P3b (latency) and PDQ baseline to endpoint percent change||||0.603
72508841|NCT02749721|144548167|OTHER||Pearson's R|-0.232||||0.326|TWO_SIDED||||||Pearson's correlation|||Correlation between VGNG P200 (latency) and PDQ baseline to endpoint percent change||||0.326
72566410|NCT02697773|144663269|SUPERIORITY||Odds Ratio (OR)|1.17||||0.4878|TWO_SIDED|95.0|0.75|1.84|||Regression, Logistic|||Week 8: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline PGA of osteoarthritis, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||1.84|0.75|0.4878
72566411|NCT02697773|144663269|SUPERIORITY||Odds Ratio (OR)|1.06||||0.7856|TWO_SIDED|95.0|0.68|1.67|||Regression, Logistic|||Week 8: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline PGA of osteoarthritis, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||1.67|0.68|0.7856
72566412|NCT02697773|144663269|SUPERIORITY||Odds Ratio (OR)|1.55||||0.0476|TWO_SIDED|95.0|1.0|2.39|||Regression, Logistic|||Week 12: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline PGA of osteoarthritis, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.39|1.00|0.0476
72566413|NCT02697773|144663269|SUPERIORITY||Odds Ratio (OR)|1.72||||0.0124|TWO_SIDED|95.0|1.12|2.63|||Regression, Logistic|||Week 12: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline PGA of osteoarthritis, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.63|1.12|0.0124
72508842|NCT02749721|144548167|OTHER||Pearson's R|0.098||||0.68|TWO_SIDED||||||Pearson's correlation|||Correlation between VGNG P3a (latency) and PDQ baseline to endpoint percent change||||0.68
72566414|NCT02697773|144663269|SUPERIORITY||Odds Ratio (OR)|1.66||||0.0307|TWO_SIDED|95.0|1.05|2.62|||Regression, Logistic|||Week 16: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline PGA of osteoarthritis, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.62|1.05|0.0307
72566415|NCT02697773|144663269|SUPERIORITY||Odds Ratio (OR)|1.49||||0.0846|TWO_SIDED|95.0|0.95|2.35|||Regression, Logistic|||Week 16: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline PGA of osteoarthritis, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.35|0.95|0.0846
72508843|NCT02749721|144548167|OTHER||Pearson's R|-0.1||||0.692|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P200 (latency) and MGH-CPFQ baseline scores||||0.692
72508844|NCT02749721|144548167|OTHER||Pearson's R|0.498||||0.059|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P3a (latency) and MGH-CPFQ baseline scores||||0.059
72508845|NCT02749721|144548167|OTHER||Pearson's R|-0.332||||0.227|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P3b (latency) and MGH-CPFQ baseline scores||||0.227
72508846|NCT02749721|144548167|OTHER||Pearson's R|-0.125||||0.6|TWO_SIDED||||||Pearson's correlation|||Correlation between VGNG P200 (latency) and MGH-CPFQ baseline scores||||0.600
72508847|NCT02749721|144548167|OTHER||Pearson's R|-0.096||||0.69|TWO_SIDED||||||Pearson's correlation|||Correlation between VGNG P3a (latency) and MGH-CPFQ baseline scores||||0.69
72508848|NCT02749721|144548167|OTHER||Pearson's R|0.259||||0.315|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P200 (latency) and MGH-CPFQ baseline to endpoint percent change||||0.315
72508849|NCT02749721|144548167|OTHER||Pearson's R|0.002||||0.996|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P3a (latency) and MGH-CPFQ baseline to endpoint percent change||||0.996
72508850|NCT02749721|144548167|OTHER||Pearson's R|0.234||||0.544|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P3b (latency) and MGH-CPFQ baseline to endpoint percent change||||0.544
72508851|NCT02749721|144548167|OTHER||Pearson's R|0.455||||0.066|TWO_SIDED||||||Pearson's correlation|||Correlation between VGNG P200 (latency) and MGH-CPFQ baseline to endpoint percent change||||0.066
72508852|NCT02749721|144548167|OTHER||Pearson's R|-0.28||||0.293|TWO_SIDED||||||Pearson's correlation|||Correlation between VGNG P3a (latency) and MGH-CPFQ baseline to endpoint percent change||||0.293
72508853|NCT02749721|144548167|OTHER||Pearson's R|0.783||||0.013|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P200 (latency) and WLQ baseline scores||||0.013
72566416|NCT02697773|144663270|SUPERIORITY||Least Square Mean Difference|-0.33|STANDARD_ERROR_OF_MEAN|0.15||0.0319|TWO_SIDED|95.0|-0.63|-0.03|||ANCOVA|||Week 1: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline diary average pain as covariate, and study site as a random effect.||-0.03|-0.63|0.0319
72566417|NCT02697773|144663270|SUPERIORITY||Least Square Mean Difference|-0.38|STANDARD_ERROR_OF_MEAN|0.15||0.0139|TWO_SIDED|95.0|-0.68|-0.08|||ANCOVA|||Week 1:Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline diary average pain as covariate, and study site as a random effect.||-0.08|-0.68|0.0139
72508854|NCT02749721|144548167|OTHER||Pearson's R|0.135||||0.799|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P3a (latency) and WLQ baseline scores||||0.799
72508855|NCT02749721|144548167|OTHER||Pearson's R|0.506||||0.201|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P3b (latency) and WLQ baseline scores||||0.201
72508856|NCT02749721|144548167|OTHER||Pearson's R|-0.197||||0.586|TWO_SIDED||||||Pearson's correlation|||Correlation between VGNG P200 (latency) and WLQ baseline scores||||0.586
72508857|NCT02749721|144548167|OTHER||Pearson's R|-0.024||||0.95|TWO_SIDED||||||Pearson's correlation|||Correlation between VGNG P3a (latency) and WLQ baseline scores||||0.95
72508858|NCT02749721|144548167|OTHER||Pearson's R|0.039||||0.92|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P200 (latency) and WLQ baseline to endpoint percent change||||0.920
72508859|NCT02749721|144548167|OTHER||Pearson's R|0.113||||0.831|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P3a (latency) and WLQ baseline to endpoint percent change||||0.831
72508860|NCT02749721|144548167|OTHER||Pearson's R|0.655||||0.23|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P3b (latency) and WLQ baseline to endpoint percent change||||0.230
72477832|NCT02074553|144481513|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|80.17|||||TWO_SIDED|90.0|77.08|83.39|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.||83.39|77.08|
72477833|NCT02074553|144481513|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|79.95|||||TWO_SIDED|90.0|76.84|83.19|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.||83.19|76.84|
72477834|NCT02074553|144481514|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|99.12|||||TWO_SIDED|90.0|91.83|106.99|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.||106.99|91.83|
72477835|NCT02074553|144481514|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|93.79|||||TWO_SIDED|90.0|86.94|101.17|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.||101.17|86.94|
72477836|NCT02074553|144481514|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|80.32|||||TWO_SIDED|90.0|74.41|86.7|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.||86.7|74.41|
72508861|NCT02749721|144548167|OTHER||Pearson's R|-0.602||||0.115|TWO_SIDED||||||Pearson's correlation|||Correlation between VGNG P200 (latency) and WLQ baseline to endpoint percent change||||0.115
72508862|NCT02749721|144548167|OTHER||Pearson's R|-0.313||||0.45|TWO_SIDED||||||Pearson's correlation|||Correlation between VGNG P3a (latency) and WLQ baseline to endpoint percent change||||0.450
72508863|NCT02137772|144548168|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|-23.5|||<|0.0001|TWO_SIDED|95.0|-32.5|-14.6||A 1-sided p-value ≤0.0249 for the risk difference was used for declaring statistical significance|Mantel Haenszel|The Mantel Haenszel analysis was adjusted for sample size for each stratum (high or low risk for CMV reactivation)||||-14.6|-32.5|<0.0001
72508864|NCT02137772|144548169|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Nominal 2-sided p-value|Log Rank|The log rank test was adjusted for sample size for each stratum (high or low risk for CMV reactivation)||||||<0.0001
72508865|NCT02137772|144548170|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|-31.3|||<|0.0001|TWO_SIDED|95.0|-39.9|-22.6||Nominal 1-sided p-value|Mantel Haenszel|The Mantel Haenszel analysis was adjusted for sample size for each stratum (high or low risk for CMV reactivation)||||-22.6|-39.9|<0.0001
72508866|NCT02137772|144548171|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|-0.4||||0.4056|TWO_SIDED|95.0|-4.0|3.2||Nominal 1-sided p-value|Mantel Haenszel|The Mantel Haenszel analysis was adjusted for sample size for each stratum (high or low risk for CMV reactivation)||||3.2|-4.0|0.4056
72508867|NCT02137772|144548172|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|-1.0||||0.2258|TWO_SIDED|95.0|-3.5|1.5||Nominal 1-sided p-value|Mantel Haenszel|The Mantel Haenszel analysis was adjusted for sample size for each stratum (high or low risk for CMV reactivation)||||1.5|-3.5|0.2258
72508868|NCT02137772|144548173|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|-31.0|||<|0.0001|TWO_SIDED|95.0|-39.6|-22.4||Nominal 1-sided p-value|Mantel Haenszel|The Mantel Haenszel analysis was adjusted for sample size for each stratum (high or low risk for CMV reactivation)||||-22.4|-39.6|<0.0001
72508869|NCT02137772|144548174|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|-23.3|||<|0.0001|TWO_SIDED|95.0|-32.3|-14.3||Nominal 1-sided p-value|Mantel Haenszel|The Mantel Haenszel analysis was adjusted for sample size for each stratum (high or low risk for CMV reactivation)||||-14.3|-32.3|<0.0001
72508870|NCT02137772|144548175|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Nominal 2-sided p-value|Log Rank|The log rank test analysis was adjusted for sample size for each stratum (high or low risk for CMV reactivation)||||||<0.0001
72508871|NCT02144220|144548183|SUPERIORITY_OR_OTHER|||||||0.39|||||||t-test, 2 sided|||||||0.39
72508872|NCT00418262|144548208|SUPERIORITY||Mean Difference (Net)|0.05|||||TWO_SIDED|95.0|-0.21|0.3|||||This is the (growth) model-estimated mean difference between visit 1 and visit 8. This estimate utilizes imputed values for missing observations.|"Tested single-group change over time from baseline (visit 1) to the study endpoint (visit 10). The null hypothesis stated that there was no change in PSE ratings over time. Bayesian growth curve models were estimated using Markov Chain Monte Carlo techniques. Several linear and nonlinear trajectory models were compared on fit to data. Mean differences and confidence intervals were generated from the posterior-predictive distribution of the best fitting growth model."||0.30|-0.21|
72508873|NCT00418262|144548208|SUPERIORITY||Mean Difference (Net)|0.11|||||TWO_SIDED|95.0|-0.42|0.6|||||This is the (growth) model-estimated mean difference between visit 1 and visit 10. This estimate utilizes imputed values for missing observations.|"Tested single-group change over time from baseline (visit 1) to the study endpoint (visit 10). The null hypothesis stated that there was no change in PSE ratings over time. Bayesian growth curve models were estimated using Markov Chain Monte Carlo techniques. Several linear and nonlinear trajectory models were compared on fit to data. Mean differences and confidence intervals were generated from the posterior-predictive distribution of the best fitting growth model."||0.60|-0.42|
72623379|NCT00323622|144777535|SUPERIORITY_OR_OTHER||1 - (R1/R2)|14.9||||0.11|TWO_SIDED|95.0|-3.88|30.28||The p-value presented is the Wald Chi-square p-value from the Cox regression model.|Regression, Cox|Point estimate of efficacy was adjusted for age, geographical area of residence, bednet use and distance from health center.||The analysis aimed to compare rates of first PFMI (RPFMI) between groups over the Months 21-33 time period. Using RFPMI, a Cox model was used to evaluate vaccine efficacy (VE) allowing for adjustment factors. VE, point estimate of efficacy adjusted for covariates, was calculated as 1 - (minus) \[Hazard Ratio (HR) in Cohort 1 - RTS,S/AS02A Group \[HR1\]) divided by HR in Cohort 1 - Engerix-B/Prevnar-Hiberix Group \[HR2\])\], i. e. 1 - (HR1/HR2).||30.28|-3.88|0.11
72477837|NCT02074553|144481514|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|87.42|||||TWO_SIDED|90.0|83.92|91.07|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.||91.07|83.92|
72477838|NCT02074553|144481514|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|78.87|||||TWO_SIDED|90.0|75.76|82.11|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.||82.11|75.76|
72477839|NCT02074553|144481514|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|78.66|||||TWO_SIDED|90.0|75.53|81.92|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.||81.92|75.53|
72623380|NCT00323622|144777535|SUPERIORITY_OR_OTHER||1 - (R1/R2)|12.79||||0.35|TWO_SIDED|95.0|-16.27|34.59||The p-value presented is the Wald Chi-square p-value from the Cox regression model.|Regression, Cox|Point estimate of efficacy was adjusted for age, geographical area of residence, bednet use and distance from health center.||The analysis aimed to compare rates of first PFMI (RPFMI) between groups over the Months 33-45 time period. Using RFPMI, a Cox model was used to evaluate vaccine efficacy (VE) allowing for adjustment factors. VE, point estimate of efficacy adjusted for covariates, was calculated as 1 - (minus) \[Hazard Ratio (HR) in Cohort 1 - RTS,S/AS02A Group \[HR1\]) divided by HR in Cohort 1 - Engerix-B/Prevnar-Hiberix Group \[HR2\])\], i. e. 1 - (HR1/HR2).||34.59|-16.27|0.35
72508874|NCT00418262|144548209|SUPERIORITY||Mean Difference (Net)|0.12|||||TWO_SIDED|95.0|-0.11|0.39|||||This is the (growth) model-estimated mean difference between visit 1 and visit 8. This estimate utilizes imputed values for missing observations.|"Tested single-group change over time from baseline (visit 1) to the study endpoint (visit 10). The null hypothesis stated that there was no change in PSE ratings over time. Bayesian growth curve models were estimated using Markov Chain Monte Carlo techniques. Several linear and nonlinear trajectory models were compared on fit to data. Mean differences and confidence intervals were generated from the posterior-predictive distribution of the best fitting growth model."||0.39|-0.11|
72508875|NCT00418262|144548209|SUPERIORITY||Mean Difference (Net)|0.24|||||TWO_SIDED|95.0|-0.23|0.77|||||This is the (growth) model-estimated mean difference between visit 1 and visit 10. This estimate utilizes imputed values for missing observations.|"Tested single-group change over time from baseline (visit 1) to the study endpoint (visit 10). The null hypothesis stated that there was no change in PSE ratings over time. Bayesian growth curve models were estimated using Markov Chain Monte Carlo techniques. Several linear and nonlinear trajectory models were compared on fit to data. Mean differences and confidence intervals were generated from the posterior-predictive distribution of the best fitting growth model."||0.77|-0.23|
72508876|NCT00418262|144548210|SUPERIORITY||Mean Difference (Net)|0.1|||||TWO_SIDED|95.0|-0.17|0.36|||||This is the (growth) model-estimated mean difference between visit 1 and visit 8. This estimate utilizes imputed values for missing observations.|"Tested single-group change over time from baseline (visit 1) to the study endpoint (visit 10). The null hypothesis stated that there was no change in PSE ratings over time. Bayesian growth curve models were estimated using Markov Chain Monte Carlo techniques. Several linear and nonlinear trajectory models were compared on fit to data. Mean differences and confidence intervals were generated from the posterior-predictive distribution of the best fitting growth model."||0.36|-0.17|
72508877|NCT00418262|144548210|SUPERIORITY||Mean Difference (Net)|0.1|||||TWO_SIDED|95.0|-0.17|0.36|||||This is the (growth) model-estimated mean difference between visit 1 and visit 10. This estimate utilizes imputed values for missing observations.|"Tested single-group change over time from baseline (visit 1) to the study endpoint (visit 10). The null hypothesis stated that there was no change in PSE ratings over time. Bayesian growth curve models were estimated using Markov Chain Monte Carlo techniques. Several linear and nonlinear trajectory models were compared on fit to data. Mean differences and confidence intervals were generated from the posterior-predictive distribution of the best fitting growth model."||0.36|-0.17|
72508878|NCT00418262|144548211|SUPERIORITY||Mean Difference (Net)|0.13|||||TWO_SIDED|95.0|-0.16|0.4|||||This is the (growth) model-estimated mean difference between visit 1 and visit 8. This estimate utilizes imputed values for missing observations.|"Tested single-group change over time from baseline (visit 1) to the study endpoint (visit 10). The null hypothesis stated that there was no change in PSE ratings over time. Bayesian growth curve models were estimated using Markov Chain Monte Carlo techniques. Several linear and nonlinear trajectory models were compared on fit to data. Mean differences and confidence intervals were generated from the posterior-predictive distribution of the best fitting growth model."||0.40|-0.16|
72508879|NCT00418262|144548211|SUPERIORITY||Mean Difference (Net)|0.13|||||TWO_SIDED|95.0|-0.16|0.4|||||This is the (growth) model-estimated mean difference between visit 1 and visit 10. This estimate utilizes imputed values for missing observations.|"Tested single-group change over time from baseline (visit 1) to the study endpoint (visit 10). The null hypothesis stated that there was no change in PSE ratings over time. Bayesian growth curve models were estimated using Markov Chain Monte Carlo techniques. Several linear and nonlinear trajectory models were compared on fit to data. Mean differences and confidence intervals were generated from the posterior-predictive distribution of the best fitting growth model."||0.40|-0.16|
72477840|NCT02074553|144481515|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|90.34|||||TWO_SIDED|90.0|82.33|99.12|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.||99.12|82.33|
72477841|NCT02074553|144481515|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|66.28|||||TWO_SIDED|90.0|60.45|72.68|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.||72.68|60.45|
72477842|NCT02074553|144481515|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|41.04|||||TWO_SIDED|90.0|37.4|45.03|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.||45.03|37.40|
72477843|NCT02074553|144481515|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|86.3|||||TWO_SIDED|90.0|81.77|91.09|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.||91.09|81.77|
72477844|NCT02074553|144481515|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|77.0|||||TWO_SIDED|90.0|73.01|81.2|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.||81.20|73.01|
72477845|NCT02074553|144481515|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|75.65|||||TWO_SIDED|90.0|71.71|79.82|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.||79.82|71.71|
72477846|NCT02074553|144481517|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|91.67|||||TWO_SIDED|90.0|82.34|102.05|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.||102.05|82.34|
72477847|NCT02074553|144481517|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|67.24|||||TWO_SIDED|90.0|60.44|74.79|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.||74.79|60.44|
72477848|NCT02074553|144481517|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|34.32|||||TWO_SIDED|90.0|30.83|38.21|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.||38.21|30.83|
72477849|NCT02074553|144481517|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|95.15|||||TWO_SIDED|90.0|89.1|101.62|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.||101.62|89.10|
72477850|NCT02074553|144481517|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|73.26|||||TWO_SIDED|90.0|68.67|78.16|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.||78.16|68.67|
72477851|NCT02074553|144481517|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|67.76|||||TWO_SIDED|90.0|63.48|72.33|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.||72.33|63.48|
72566418|NCT02697773|144663270|SUPERIORITY||Least Square Mean Difference|-0.64|STANDARD_ERROR_OF_MEAN|0.2||0.0011|TWO_SIDED|95.0|-1.03|-0.25|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline diary average pain as covariate, and study site as a random effect.||-0.25|-1.03|0.0011
72566419|NCT02697773|144663270|SUPERIORITY||Least Square Mean Difference|-0.55|STANDARD_ERROR_OF_MEAN|0.2||0.0053|TWO_SIDED|95.0|-0.93|-0.16|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline diary average pain as covariate, and study site as a random effect.||-0.16|-0.93|0.0053
72477852|NCT02074553|144481519|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|95.77|||||TWO_SIDED|90.0|87.54|104.79|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.||104.79|87.54|
72477853|NCT02074553|144481519|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|78.69|||||TWO_SIDED|90.0|71.97|86.04|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.||86.04|71.97|
72477854|NCT02074553|144481519|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|53.91|||||TWO_SIDED|90.0|49.27|58.98|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.||58.98|49.27|
72477855|NCT02074553|144481519|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|90.16|||||TWO_SIDED|90.0|86.14|94.37|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.||94.37|86.14|
72477856|NCT02074553|144481519|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|73.76|||||TWO_SIDED|90.0|70.52|77.15|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.||77.15|70.52|
72477857|NCT02074553|144481519|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|70.94|||||TWO_SIDED|90.0|67.8|74.22|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.||74.22|67.80|
72477858|NCT02074553|144481520|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|93.05|||||TWO_SIDED|90.0|84.24|102.78|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.||102.78|84.24|
72477859|NCT02074553|144481520|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|74.35|||||TWO_SIDED|90.0|67.37|82.06|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.||82.06|67.37|
72477860|NCT02074553|144481520|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|43.94|||||TWO_SIDED|90.0|39.78|48.53|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.||48.53|39.78|
72477861|NCT02074553|144481520|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|90.21|||||TWO_SIDED|90.0|86.12|94.49|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.||94.49|86.12|
72477862|NCT02074553|144481520|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|72.72|||||TWO_SIDED|90.0|69.48|76.12|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.||76.12|69.48|
72477863|NCT02074553|144481520|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|69.34|||||TWO_SIDED|90.0|66.23|72.61|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.||72.61|66.23|
72477864|NCT02074553|144481523|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|98.79|||||TWO_SIDED|90.0|91.25|106.95|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.||106.95|91.25|
72477865|NCT02074553|144481523|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|91.58|||||TWO_SIDED|90.0|84.65|99.08|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.||99.08|84.65|
72477866|NCT02074553|144481523|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|73.41|||||TWO_SIDED|90.0|67.81|79.47|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.||79.47|67.81|
72477867|NCT02074553|144481523|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|88.81|||||TWO_SIDED|90.0|85.62|92.13|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.||92.13|85.62|
72477868|NCT02074553|144481523|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|77.74|||||TWO_SIDED|90.0|74.99|80.6|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.||80.60|74.99|
72477869|NCT02074553|144481523|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|76.65|||||TWO_SIDED|90.0|73.92|79.49|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.||79.49|73.92|
72477870|NCT02074553|144481524|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|89.41|||||TWO_SIDED|90.0|81.7|97.84|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.||97.84|81.7|
72477871|NCT02074553|144481524|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|66.84|||||TWO_SIDED|90.0|61.12|73.1|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.||73.1|61.12|
72477872|NCT02074553|144481524|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|42.32|||||TWO_SIDED|90.0|38.68|46.32|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.||46.32|38.68|
72508880|NCT00418262|144548212|SUPERIORITY||Mean Difference (Net)|-0.07|||||TWO_SIDED|95.0|-0.36|0.18|||||This is the (growth) model-estimated mean difference between visit 1 and visit 8. This estimate utilizes imputed values for missing observations.|"Tested single-group change over time from baseline (visit 1) to the study endpoint (visit 10). The null hypothesis stated that there was no change in PSE ratings over time. Bayesian growth curve models were estimated using Markov Chain Monte Carlo techniques. Several linear and nonlinear trajectory models were compared on fit to data. Mean differences and confidence intervals were generated from the posterior-predictive distribution of the best fitting growth model."||0.18|-0.36|
72508881|NCT00418262|144548212|SUPERIORITY||Mean Difference (Net)|-0.07|||||TWO_SIDED|95.0|-0.36|0.18|||||This is the (growth) model-estimated mean difference between visit 1 and visit 10. This estimate utilizes imputed values for missing observations.|"Tested single-group change over time from baseline (visit 1) to the study endpoint (visit 10). The null hypothesis stated that there was no change in PSE ratings over time. Bayesian growth curve models were estimated using Markov Chain Monte Carlo techniques. Several linear and nonlinear trajectory models were compared on fit to data. Mean differences and confidence intervals were generated from the posterior-predictive distribution of the best fitting growth model."||0.18|-0.36|
72566420|NCT02697773|144663270|SUPERIORITY||Least Square Mean Difference|-0.67|STANDARD_ERROR_OF_MEAN|0.21||0.0014|TWO_SIDED|95.0|-1.08|-0.26|||ANCOVA|||Week 3: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline diary average pain as covariate, and study site as a random effect.||-0.26|-1.08|0.0014
72477873|NCT02074553|144481524|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|88.76|||||TWO_SIDED|90.0|84.21|93.56|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.||93.56|84.21|
72477874|NCT02074553|144481524|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|75.82|||||TWO_SIDED|90.0|71.99|79.86|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.||79.86|71.99|
72477875|NCT02074553|144481524|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|73.26|||||TWO_SIDED|90.0|69.53|77.19|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.||77.19|69.53|
72477876|NCT02074553|144481525|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|97.23|||||TWO_SIDED|90.0|89.85|105.21|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.||105.21|89.85|
72477877|NCT02074553|144481525|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|87.16|||||TWO_SIDED|90.0|80.59|94.26|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.||94.26|80.59|
72477878|NCT02074553|144481525|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|67.86|||||TWO_SIDED|90.0|62.71|73.43|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.||73.43|62.71|
72477879|NCT02074553|144481525|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|88.28|||||TWO_SIDED|90.0|85.06|91.63|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.||91.63|85.06|
72508882|NCT00418262|144548213|SUPERIORITY||Mean Difference (Net)|0.04|||||TWO_SIDED|95.0|-0.2|0.35|||||This is the (growth) model-estimated mean difference between visit 1 and visit 8. This estimate utilizes imputed values for missing observations.|"Tested single-group change over time from baseline (visit 1) to the study endpoint (visit 10). The null hypothesis stated that there was no change in PSE ratings over time. Bayesian growth curve models were estimated using Markov Chain Monte Carlo techniques. Several linear and nonlinear trajectory models were compared on fit to data. Mean differences and confidence intervals were generated from the posterior-predictive distribution of the best fitting growth model."||0.35|-0.20|
72508883|NCT00418262|144548213|SUPERIORITY||Mean Difference (Net)|0.04|||||TWO_SIDED|95.0|-0.2|0.35|||||This is the (growth) model-estimated mean difference between visit 1 and visit 10. This estimate utilizes imputed values for missing observations.|"Tested single-group change over time from baseline (visit 1) to the study endpoint (visit 10). The null hypothesis stated that there was no change in PSE ratings over time. Bayesian growth curve models were estimated using Markov Chain Monte Carlo techniques. Several linear and nonlinear trajectory models were compared on fit to data. Mean differences and confidence intervals were generated from the posterior-predictive distribution of the best fitting growth model."||0.35|-0.20|
72477880|NCT02074553|144481525|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|76.79|||||TWO_SIDED|90.0|74.03|79.65|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.||79.65|74.03|
72477881|NCT02074553|144481525|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|75.43|||||TWO_SIDED|90.0|72.7|78.27|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.||78.27|72.70|
72477882|NCT02342743|144481566|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
72477883|NCT02342743|144481567|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
72477884|NCT02342743|144481568|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
72477885|NCT02342743|144481569|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
72477886|NCT02342743|144481570|SUPERIORITY|||||||0.012||||||Threshold for statistical significance set to 0.05|Wilcoxon (Mann-Whitney)|||||||0.012
72477887|NCT02342743|144481571|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
72508884|NCT00418262|144548214|SUPERIORITY||Mean Difference (Net)|-0.03|||||TWO_SIDED|95.0|-0.24|0.24|||||This is the (growth) model-estimated mean difference between visit 1 and visit 8. This estimate utilizes imputed values for missing observations.|"Tested single-group change over time from baseline (visit 1) to the study endpoint (visit 10). The null hypothesis stated that there was no change in PSE ratings over time. Bayesian growth curve models were estimated using Markov Chain Monte Carlo techniques. Several linear and nonlinear trajectory models were compared on fit to data. Mean differences and confidence intervals were generated from the posterior-predictive distribution of the best fitting growth model."||0.24|-0.24|
72508885|NCT00418262|144548214|SUPERIORITY||Mean Difference (Net)|-0.06|||||TWO_SIDED|95.0|-0.49|0.49|||||This is the (growth) model-estimated mean difference between visit 1 and visit 10. This estimate utilizes imputed values for missing observations.|"Tested single-group change over time from baseline (visit 1) to the study endpoint (visit 10). The null hypothesis stated that there was no change in PSE ratings over time. Bayesian growth curve models were estimated using Markov Chain Monte Carlo techniques. Several linear and nonlinear trajectory models were compared on fit to data. Mean differences and confidence intervals were generated from the posterior-predictive distribution of the best fitting growth model."||0.49|-0.49|
72508886|NCT00418262|144548215|SUPERIORITY||Mean Difference (Net)|0.0|||||TWO_SIDED|95.0|-0.28|0.26|||||This is the (growth) model-estimated mean difference between visit 1 and visit 8. This estimate utilizes imputed values for missing observations.|"Tested single-group change over time from baseline (visit 1) to the study endpoint (visit 10). The null hypothesis stated that there was no change in PSE ratings over time. Bayesian growth curve models were estimated using Markov Chain Monte Carlo techniques. Several linear and nonlinear trajectory models were compared on fit to data. Mean differences and confidence intervals were generated from the posterior-predictive distribution of the best fitting growth model."||0.26|-0.28|
72477888|NCT02342743|144481573|SUPERIORITY|||||||0.03||||||Threshold for statistical significance set to 0.05|Wilcoxon (Mann-Whitney)|||||||0.030
72477889|NCT04187989|144481574|OTHER|Two-sided test of the null hypothesis of no difference between groups|Cohen's D|-0.006|STANDARD_ERROR_OF_MEAN|0.239||0.98|TWO_SIDED|95.0|-0.478|0.466|||t-test, 2 sided|The p-value is for the coefficient of the treatment/control indicator in the above mixed model|The effect size used is the adjusted Cohen's D, calculated from the coefficient for treatment group in the mixed model, divided by total pooled SD (the square root of the sum of the residual variance+the variance of the group-level random effects).|We fixed linear mixed effects models adjusted for baseline values, balancing factors (age, sex, recreational cannabis), and included a random intercept for group because this is an individually randomized group treatment trial. We tested for treatment effects with a two-sided test of the coefficient for the treatment/control indicator, and estimated Cohen's D (mean difference between the 2 groups at follow-up divided by the total variation not captured by the fixed effects) along with 95% CIs.||.466|-.478|.980
72477890|NCT04187989|144481575|OTHER|Two-sided test of the null hypothesis of no difference between groups|Cohen's D|0.265|STANDARD_ERROR_OF_MEAN|0.18||0.14|TWO_SIDED|95.0|-0.092|0.621||The p-value is for the coefficient of the treatment/control indicator in the above mixed model|t-test, 2 sided||The effect size used is the adjusted Cohen's D, calculated from the coefficient for treatment group in the mixed model, divided by total pooled SD (the square root of the sum of the residual variance+the variance of the group-level random effects).|We fixed linear mixed effects models adjusted for baseline values, balancing factors (age, sex, recreational cannabis), and included a random intercept for group because this is an individually randomized group treatment trial. We tested for treatment effects with a two-sided test of the coefficient for the treatment/control indicator, and estimated Cohen's D (mean difference between the 2 groups at follow-up divided by the total variation not captured by the fixed effects) along with 95% CIs.||.621|-.092|.140
72477891|NCT04187989|144481577|OTHER|Two-sided test of the null hypothesis of no difference between groups|Cohen's D|0.064|STANDARD_ERROR_OF_MEAN|0.181||0.724|TWO_SIDED|95.0|-0.294|0.421||Two-sided test of the null hypothesis of no difference between groups|t-test, 2 sided|The p-value is for the coefficient of the treatment/control indicator in the above mixed model|The effect size used is the adjusted Cohen's D, calculated from the coefficient for treatment group in the mixed model, divided by total pooled SD (the square root of the sum of the residual variance+the variance of the group-level random effects).|We fixed linear mixed effects models adjusted for baseline values, balancing factors (age, sex, recreational cannabis), and included a random intercept for group because this is an individually randomized group treatment trial. We tested for treatment effects with a two-sided test of the coefficient for the treatment/control indicator, and estimated Cohen's D (mean difference between the 2 groups at follow-up divided by the total variation not captured by the fixed effects) along with 95% CIs.||.421|-.294|.724
72477892|NCT04187989|144481578|OTHER|Two-sided test of the null hypothesis of no difference between groups|Cohen's D|-0.078|STANDARD_ERROR_OF_MEAN|0.175||0.656|TWO_SIDED|95.0|-0.425|0.269|||t-test, 2 sided|The p-value is for the coefficient of the treatment/control indicator in the above mixed model|The effect size used is the adjusted Cohen's D, calculated from the coefficient for treatment group in the mixed model, divided by total pooled SD (the square root of the sum of the residual variance+the variance of the group-level random effects).|We fixed linear mixed effects models adjusted for baseline values, balancing factors (age, sex, recreational cannabis), and included a random intercept for group because this is an individually randomized group treatment trial. We tested for treatment effects with a two-sided test of the coefficient for the treatment/control indicator, and estimated Cohen's D (mean difference between the 2 groups at follow-up divided by the total variation not captured by the fixed effects) along with 95% CIs.||.269|-.425|.656
72477893|NCT04187989|144481579|OTHER|Two-sided test of the null hypothesis of no difference between groups|Cohen's D|-0.339|STANDARD_ERROR_OF_MEAN|0.205||0.158|TWO_SIDED|95.0|-0.746|0.067||The p-value is for the coefficient of the treatment/control indicator in the above mixed model|t-test, 2 sided||The effect size used is the adjusted Cohen's D, calculated from the coefficient for treatment group in the mixed model, divided by total pooled SD (the square root of the sum of the residual variance+the variance of the group-level random effects).|||0.067|-.746|.158
72399834|NCT01996826|144307301|OTHER|Based on prior studies endothelial rejection episodes tend to occur in the range of about 60% of transplants. We used rates ranging from 50 to 70 % to compute the sample size. We specified the probability of a type 1 error equal to 0.05, study power equal to 80%, a follow-up period of 12 months, and 4% loss to follow-up. Calculations resulted in sample size estimates of between 65 and 124 participants.|Hazard Ratio (HR)|0.35||||0.1|TWO_SIDED|95.0|0.12|1.14|||Log Rank|||Endothelial rejection rates in patients in the treatment group and the control group were calculated using the Kaplan-Meier survival curve. The Kaplan-Meier/product limit estimator is a non-parametric statistical test used to show the probability of an event occurring at a given time interval. The Kaplan-Meier estimator is used to show what the probability of corneal transplant rejection (and therefore transplant survival) after administration of the active treatment or control.||1.14|0.12|0.10
72399835|NCT01996826|144307302|OTHER|The count of ocular adverse events for subjects in intervention group (Avastin® (bevacizumab) and control group (0.9% NaCl \& Refresh Liquigel) were counted and compared.|Risk Ratio (RR)|0.92||||0.36|TWO_SIDED|95.0|0.78|1.06|||Fisher Exact|||The incidence of Ocular Adverse Events for subjects in intervention group (Avastin® (bevacizumab) and control group (0.9% NaCl \& Refresh Liquigel) were counted and compared.||1.06|0.78|0.36
72399836|NCT01996826|144307302|OTHER|Mild ocular adverse events for subjects in intervention group and control group were counted and compared.|Risk Ratio (RR)|0.95||||0.82|TWO_SIDED|95.0|0.63|1.4|||Fisher Exact|||The number of mild severity Ocular Adverse Events for subjects in intervention group (Avastin® (bevacizumab) and control group (0.9% NaCl \& Refresh Liquigel) were counted and compared.||1.4|0.63|0.82
72399837|NCT01996826|144307302|OTHER|Moderate severity ocular adverse events for subjects in intervention group and control group were counted and compared.|Risk Ratio (RR)|0.95|||>|0.99|TWO_SIDED|95.0|0.41|2.2|||Fisher Exact|||The number of moderate severity Ocular Adverse Events for subjects in intervention group (Avastin® (bevacizumab) and control group (0.9% NaCl \& Refresh Liquigel) were counted and compared.||2.2|0.41|>0.99
72399838|NCT01996826|144307302|OTHER|Severe ocular adverse events for subjects in intervention group and control group were counted and compared.|Risk Ratio (RR)|0.63||||0.51|TWO_SIDED|95.0|0.2|1.9|||Fisher Exact|||Severe ocular adverse events for subjects in intervention group and control group were counted and compared.||1.9|0.20|0.51
72399839|NCT01996826|144307303|OTHER|The incidence of Systematic Adverse Events for subjects in intervention group (Avastin® (bevacizumab) and control group (0.9% NaCl \& Refresh Liquigel) were calculated and compared.|Risk Ratio (RR)|0.92||||0.24|TWO_SIDED|95.0|0.79|1.02|||Fisher Exact|||||1.02|0.79|0.24
72399840|NCT01996826|144307303|OTHER|Mild severity systemic adverse events for subjects in intervention group and control group were counted and compared.|Risk Ratio (RR)|1.62||||0.4|TWO_SIDED|95.0|0.68|3.9|||Fisher Exact|||The number of mild systemic Adverse Events for subjects in intervention group (Avastin® (bevacizumab) and control group (0.9% NaCl \& Refresh Liquigel) were counted and compared.||3.9|0.68|0.40
72399841|NCT01996826|144307303|OTHER|Moderate severity systemic adverse events for subjects in intervention group and control group were counted and compared.|Risk Ratio (RR)|1.95|||>|0.99|TWO_SIDED|95.0|0.26|14.5|||Fisher Exact|||The number of moderate severity systemic Adverse Events for subjects in intervention group (Avastin® (bevacizumab) and control group (0.9% NaCl \& Refresh Liquigel) were counted and compared.||14.5|0.26|>0.99
72477894|NCT04187989|144481580|OTHER|Two-sided test of the null hypothesis of no difference between groups|Cohen's D|0.143|STANDARD_ERROR_OF_MEAN|0.178||0.422|TWO_SIDED|95.0|-0.21|0.495|||t-test, 2 sided|The p-value is for the coefficient of the treatment/control indicator in the above mixed model|The effect size used is the adjusted Cohen's D, calculated from the coefficient for treatment group in the mixed model, divided by total pooled SD (the square root of the sum of the residual variance+the variance of the group-level random effects).|We fixed linear mixed effects models adjusted for baseline values, balancing factors (age, sex, recreational cannabis), and included a random intercept for group because this is an individually randomized group treatment trial. We tested for treatment effects with a two-sided test of the coefficient for the treatment/control indicator, and estimated Cohen's D (mean difference between the 2 groups at follow-up divided by the total variation not captured by the fixed effects) along with 95% CIs.||.495|-.210|.422
72508887|NCT00418262|144548215|SUPERIORITY||Mean Difference (Net)|-0.01|||||TWO_SIDED|95.0|-0.56|0.52|||||This is the (growth) model-estimated mean difference between visit 1 and visit 10. This estimate utilizes imputed values for missing observations.|"Tested single-group change over time from baseline (visit 1) to the study endpoint (visit 10). The null hypothesis stated that there was no change in PSE ratings over time. Bayesian growth curve models were estimated using Markov Chain Monte Carlo techniques. Several linear and nonlinear trajectory models were compared on fit to data. Mean differences and confidence intervals were generated from the posterior-predictive distribution of the best fitting growth model."||0.52|-0.56|
72508888|NCT00418262|144548216|SUPERIORITY||Mean Difference (Net)|-0.06|||||TWO_SIDED|95.0|-0.32|0.2|||||This is the (growth) model-estimated mean difference between visit 1 and visit 8. This estimate utilizes imputed values for missing observations.|"Tested single-group change over time from baseline (visit 1) to the study endpoint (visit 10). The null hypothesis stated that there was no change in PSE ratings over time. Bayesian growth curve models were estimated using Markov Chain Monte Carlo techniques. Several linear and nonlinear trajectory models were compared on fit to data. Mean differences and confidence intervals were generated from the posterior-predictive distribution of the best fitting growth model."||0.20|-0.32|
72566421|NCT02697773|144663270|SUPERIORITY||Least Square Mean Difference|-0.77|STANDARD_ERROR_OF_MEAN|0.21||0.0002|TWO_SIDED|95.0|-1.17|-0.36|||ANCOVA|||Week 3: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline diary average pain as covariate, and study site as a random effect.||-0.36|-1.17|0.0002
72399842|NCT01996826|144307303|OTHER|Severe systemic adverse events for subjects in intervention group and control group were counted and compared.|Risk Ratio (RR)|1.9|||>|0.99|TWO_SIDED|95.0|0.26|14.5|||Fisher Exact|||The number of severe systemic Adverse Events for subjects in intervention group (Avastin® (bevacizumab) and control group (0.9% NaCl \& Refresh Liquigel) were counted and compared.||14.5|0.26|>0.99
72477895|NCT04187989|144481581|OTHER|Two-sided test of the null hypothesis of no difference between groups|Cohen's D|0.027|STANDARD_ERROR_OF_MEAN|0.179||0.882|TWO_SIDED|95.0|-0.328|0.381|||t-test, 2 sided||The effect size used is the adjusted Cohen's D, calculated from the coefficient for treatment group in the mixed model, divided by total pooled SD (the square root of the sum of the residual variance+the variance of the group-level random effects).|We fixed linear mixed effects models adjusted for baseline values, balancing factors (age, sex, recreational cannabis), and included a random intercept for group because this is an individually randomized group treatment trial. We tested for treatment effects with a two-sided test of the coefficient for the treatment/control indicator, and estimated Cohen's D (mean difference between the 2 groups at follow-up divided by the total variation not captured by the fixed effects) along with 95% CIs||.381|-.328|.882
72477896|NCT04187989|144481582|OTHER|Two-sided test of the null hypothesis of no difference between groups|Cohen's D|-0.197|STANDARD_ERROR_OF_MEAN|0.268||0.497|TWO_SIDED|95.0|-0.728|0.334||The p-value is for the coefficient of the treatment/control indicator in the above mixed model|t-test, 2 sided||The effect size used is the adjusted Cohen's D, calculated from the coefficient for treatment group in the mixed model, divided by total pooled SD (the square root of the sum of the residual variance+the variance of the group-level random effects).|We fixed linear mixed effects models adjusted for baseline values, balancing factors (age, sex, recreational cannabis), and included a random intercept for group because this is an individually randomized group treatment trial. We tested for treatment effects with a two-sided test of the coefficient for the treatment/control indicator, and estimated Cohen's D (mean difference between the 2 groups at follow-up divided by the total variation not captured by the fixed effects) along with 95% CIs.||.334|-.728|.497
72477897|NCT04187989|144481583|OTHER|Two-sided test of the null hypothesis of no difference between groups|Cohen's D|-0.042|STANDARD_ERROR_OF_MEAN|0.18||0.813|TWO_SIDED|95.0|-0.398|0.313||The p-value is for the coefficient of the treatment/control indicator in the above mixed model|t-test, 2 sided||The effect size used is the adjusted Cohen's D, calculated from the coefficient for treatment group in the mixed model, divided by total pooled SD (the square root of the sum of the residual variance+the variance of the group-level random effects).|We fixed linear mixed effects models adjusted for baseline values, balancing factors (age, sex, recreational cannabis), and included a random intercept for group because this is an individually randomized group treatment trial. We tested for treatment effects with a two-sided test of the coefficient for the treatment/control indicator, and estimated Cohen's D (mean difference between the 2 groups at follow-up divided by the total variation not captured by the fixed effects) along with 95% CIs.||.313|-.398|.813
72477898|NCT04187989|144481584|OTHER|Two-sided test of the null hypothesis of no difference between groups|Cohen's D|-0.034|STANDARD_ERROR_OF_MEAN|0.176||0.849|TWO_SIDED|95.0|-0.381|0.314||The p-value is for the coefficient of the treatment/control indicator in the above mixed model|t-test, 2 sided||The effect size used is the adjusted Cohen's D, calculated from the coefficient for treatment group in the mixed model, divided by total pooled SD (the square root of the sum of the residual variance+the variance of the group-level random effects).|We fixed linear mixed effects models adjusted for baseline values, balancing factors (age, sex, recreational cannabis), and included a random intercept for group because this is an individually randomized group treatment trial. We tested for treatment effects with a two-sided test of the coefficient for the treatment/control indicator, and estimated Cohen's D (mean difference between the 2 groups at follow-up divided by the total variation not captured by the fixed effects) along with 95% CIs.||.314|-.381|.849
72477899|NCT04187989|144481585|OTHER|Two-sided test of the null hypothesis of no difference between groups|Cohen's D|-0.118|STANDARD_ERROR_OF_MEAN|0.247||0.667|TWO_SIDED|95.0|-0.607|0.371||The p-value is for the coefficient of the treatment/control indicator in the above mixed model|t-test, 2 sided||The effect size used is the adjusted Cohen's D, calculated from the coefficient for treatment group in the mixed model, divided by total pooled SD (the square root of the sum of the residual variance+the variance of the group-level random effects|We fixed linear mixed effects models adjusted for baseline values, balancing factors (age, sex, recreational cannabis), and included a random intercept for group because this is an individually randomized group treatment trial. We tested for treatment effects with a two-sided test of the coefficient for the treatment/control indicator, and estimated Cohen's D (mean difference between the 2 groups at follow-up divided by the total variation not captured by the fixed effects) along with 95% CIs.||.371|-.607|.667
72477900|NCT04187989|144481586|OTHER|Two-sided test of the null hypothesis of no difference between groups|Cohen's D|-0.342|STANDARD_ERROR_OF_MEAN|0.175||0.051|TWO_SIDED|95.0|-0.689|0.005|||t-test, 2 sided|The p-value is for the coefficient of the treatment/control indicator in the above mixed model|The effect size used is the adjusted Cohen's D, calculated from the coefficient for treatment group in the mixed model, divided by total pooled SD (the square root of the sum of the residual variance+the variance of the group-level random effects|We fixed linear mixed effects models adjusted for baseline values, balancing factors (age, sex, recreational cannabis), and included a random intercept for group because this is an individually randomized group treatment trial. We tested for treatment effects with a two-sided test of the coefficient for the treatment/control indicator, and estimated Cohen's D (mean difference between the 2 groups at follow-up divided by the total variation not captured by the fixed effects) along with 95% CIs||.005|-.689|.051
72477901|NCT04187989|144481587|OTHER|Two-sided test of the null hypothesis of no difference between groups|Cohen's D|-0.064|STANDARD_ERROR_OF_MEAN|0.176||0.714|TWO_SIDED|95.0|-0.412|0.284|||t-test, 2 sided|The p-value is for the coefficient of the treatment/control indicator in the above mixed model||We fixed linear mixed effects models adjusted for baseline values, balancing factors (age, sex, recreational cannabis), and included a random intercept for group because this is an individually randomized group treatment trial. We tested for treatment effects with a two-sided test of the coefficient for the treatment/control indicator, and estimated Cohen's D (mean difference between the 2 groups at follow-up divided by the total variation not captured by the fixed effects) along with 95% CIs.|The effect size used is the adjusted Cohen's D, calculated from the coefficient for treatment group in the mixed model, divided by total pooled SD (the square root of the sum of the residual variance+the variance of the group-level random effects).|.284|-.412|.714
72508889|NCT00418262|144548216|SUPERIORITY||Median Difference (Net)|-0.12|||||TWO_SIDED|95.0|-0.64|0.39|||||This is the (growth) model-estimated mean difference between visit 1 and visit 10. This estimate utilizes imputed values for missing observations.|"Tested single-group change over time from baseline (visit 1) to the study endpoint (visit 10). The null hypothesis stated that there was no change in PSE ratings over time. Bayesian growth curve models were estimated using Markov Chain Monte Carlo techniques. Several linear and nonlinear trajectory models were compared on fit to data. Mean differences and confidence intervals were generated from the posterior-predictive distribution of the best fitting growth model."||0.39|-0.64|
72508890|NCT00418262|144548217|SUPERIORITY||Mean Difference (Net)|-0.05|||||TWO_SIDED|95.0|-0.28|0.24|||||This is the (growth) model-estimated mean difference between visit 1 and visit 8. This estimate utilizes imputed values for missing observations.|"Tested single-group change over time from baseline (visit 1) to the study endpoint (visit 10). The null hypothesis stated that there was no change in PSE ratings over time. Bayesian growth curve models were estimated using Markov Chain Monte Carlo techniques. Several linear and nonlinear trajectory models were compared on fit to data. Mean differences and confidence intervals were generated from the posterior-predictive distribution of the best fitting growth model."||0.24|-0.28|
72508891|NCT00418262|144548217|SUPERIORITY||Mean Difference (Net)|-0.09|||||TWO_SIDED|95.0|-0.57|0.47|||||This is the (growth) model-estimated mean difference between visit 1 and visit 10. This estimate utilizes imputed values for missing observations.|"Tested single-group change over time from baseline (visit 1) to the study endpoint (visit 10). The null hypothesis stated that there was no change in PSE ratings over time. Bayesian growth curve models were estimated using Markov Chain Monte Carlo techniques. Several linear and nonlinear trajectory models were compared on fit to data. Mean differences and confidence intervals were generated from the posterior-predictive distribution of the best fitting growth model."||0.47|-0.57|
72508892|NCT00418262|144548218|SUPERIORITY||Mean Difference (Net)|0.07|||||TWO_SIDED|95.0|-0.21|0.32|||||This is the (growth) model-estimated mean difference between visit 1 and visit 8. This estimate utilizes imputed values for missing observations.|"Tested single-group change over time from baseline (visit 1) to the study endpoint (visit 10). The null hypothesis stated that there was no change in PSE ratings over time. Bayesian growth curve models were estimated using Markov Chain Monte Carlo techniques. Several linear and nonlinear trajectory models were compared on fit to data. Mean differences and confidence intervals were generated from the posterior-predictive distribution of the best fitting growth model."||0.32|-0.21|
72508893|NCT00418262|144548218|SUPERIORITY||Mean Difference (Net)|0.07|||||TWO_SIDED|95.0|-0.21|0.32|||||This is the (growth) model-estimated mean difference between visit 1 and visit 10. This estimate utilizes imputed values for missing observations.|"Tested single-group change over time from baseline (visit 1) to the study endpoint (visit 10). The null hypothesis stated that there was no change in PSE ratings over time. Bayesian growth curve models were estimated using Markov Chain Monte Carlo techniques. Several linear and nonlinear trajectory models were compared on fit to data. Mean differences and confidence intervals were generated from the posterior-predictive distribution of the best fitting growth model."||0.32|-0.21|
72508894|NCT00418262|144548219|SUPERIORITY||Mean Difference (Net)|-0.11|||||TWO_SIDED|95.0|-0.36|0.13|||||This is the (growth) model-estimated mean difference between visit 1 and visit 8. This estimate utilizes imputed values for missing observations.|"Tested single-group change over time from baseline (visit 1) to the study endpoint (visit 10). The null hypothesis stated that there was no change in PSE ratings over time. Bayesian growth curve models were estimated using Markov Chain Monte Carlo techniques. Several linear and nonlinear trajectory models were compared on fit to data. Mean differences and confidence intervals were generated from the posterior-predictive distribution of the best fitting growth model."||0.13|-0.36|
72508895|NCT00418262|144548219|SUPERIORITY||Mean Difference (Net)|-0.22|||||TWO_SIDED|95.0|-0.72|0.27|||||This is the (growth) model-estimated mean difference between visit 1 and visit 10. This estimate utilizes imputed values for missing observations.|"Tested single-group change over time from baseline (visit 1) to the study endpoint (visit 10). The null hypothesis stated that there was no change in PSE ratings over time. Bayesian growth curve models were estimated using Markov Chain Monte Carlo techniques. Several linear and nonlinear trajectory models were compared on fit to data. Mean differences and confidence intervals were generated from the posterior-predictive distribution of the best fitting growth model."||0.27|-0.72|
72508896|NCT00418262|144548220|SUPERIORITY||Mean Difference (Net)|0.08|||||TWO_SIDED|95.0|-0.19|0.35|||||This is the (growth) model-estimated mean difference between visit 1 and visit 8. This estimate utilizes imputed values for missing observations.|"Tested single-group change over time from baseline (visit 1) to the study endpoint (visit 10). The null hypothesis stated that there was no change in PSE ratings over time. Bayesian growth curve models were estimated using Markov Chain Monte Carlo techniques. Several linear and nonlinear trajectory models were compared on fit to data. Mean differences and confidence intervals were generated from the posterior-predictive distribution of the best fitting growth model."||0.35|-0.19|
72508897|NCT00418262|144548220|SUPERIORITY||Mean Difference (Net)|0.08|||||TWO_SIDED|95.0|-0.19|0.35|||||This is the (growth) model-estimated mean difference between visit 1 and visit 10. This estimate utilizes imputed values for missing observations.|"Tested single-group change over time from baseline (visit 1) to the study endpoint (visit 10). The null hypothesis stated that there was no change in PSE ratings over time. Bayesian growth curve models were estimated using Markov Chain Monte Carlo techniques. Several linear and nonlinear trajectory models were compared on fit to data. Mean differences and confidence intervals were generated from the posterior-predictive distribution of the best fitting growth model."||0.35|-0.19|
72508898|NCT00418262|144548221|SUPERIORITY||Mean Difference (Net)|-7.4|||||TWO_SIDED|95.0|-7.76|-7.04|||||This is the (growth) model-estimated mean difference between visit 1 and visit 8. This estimate utilizes imputed values for missing observations.|"Tested single-group change over time from baseline (visit 1) to the study endpoint (visit 10). The null hypothesis stated that there was no change in PSE ratings over time. Bayesian growth curve models were estimated using Markov Chain Monte Carlo techniques. Several linear and nonlinear trajectory models were compared on fit to data. Mean differences and confidence intervals were generated from the posterior-predictive distribution of the best fitting growth model."||-7.04|-7.76|
72477902|NCT04187989|144481588|OTHER|Two-sided test of the null hypothesis of no difference between groups|Cohen's D|-0.11|STANDARD_ERROR_OF_MEAN|0.212||0.603|TWO_SIDED|95.0|-0.531|0.311|||t-test, 2 sided|The p-value is for the coefficient of the treatment/control indicator in the above mixed model|The effect size used is the adjusted Cohen's D, calculated from the coefficient for treatment group in the mixed model, divided by total pooled SD (the square root of the sum of the residual variance+the variance of the group-level random effects).|: We fixed linear mixed effects models adjusted for baseline values, balancing factors (age, sex, recreational cannabis), and included a random intercept for group because this is an individually randomized group treatment trial. We tested for treatment effects with a two-sided test of the coefficient for the treatment/control indicator, and estimated Cohen's D (mean difference between the 2 groups at follow-up divided by the total variation not captured by the fixed effects) along with 95% CIs.||.311|-.531|.603
72477903|NCT04187989|144481589|OTHER|Two-sided test of the null hypothesis of no difference between groups|Cohen's D|0.162|STANDARD_ERROR_OF_MEAN|0.219||0.457|TWO_SIDED|95.0|-0.273|0.597|||Cohen's D|The p-value is for the coefficient of the treatment/control indicator in the above mixed model|The effect size used is the adjusted Cohen's D, calculated from the coefficient for treatment group in the mixed model, divided by total pooled SD (the square root of the sum of the residual variance+the variance of the group-level random effects)|We fixed linear mixed effects models adjusted for baseline values, balancing factors (age, sex, recreational cannabis), and included a random intercept for group because this is an individually randomized group treatment trial. We tested for treatment effects with a two-sided test of the coefficient for the treatment/control indicator, and estimated Cohen's D (mean difference between the 2 groups at follow-up divided by the total variation not captured by the fixed effects) along with 95% CIs.||.597|-.273|.457
72477904|NCT04187989|144481590|OTHER|Two-sided test of the null hypothesis of no difference between groups|Cohen's D|-0.265|STANDARD_ERROR_OF_MEAN|0.212||0.209|TWO_SIDED|95.0|-0.686|0.156|||t-test, 2 sided|The p-value is for the coefficient of the treatment/control indicator in the above mixed model|The effect size used is the adjusted Cohen's D, calculated from the coefficient for treatment group in the mixed model, divided by total pooled SD (the square root of the sum of the residual variance+the variance of the group-level random effects).|We fixed linear mixed effects models adjusted for baseline values, balancing factors (age, sex, recreational cannabis), and included a random intercept for group because this is an individually randomized group treatment trial. We tested for treatment effects with a two-sided test of the coefficient for the treatment/control indicator, and estimated Cohen's D (mean difference between the 2 groups at follow-up divided by the total variation not captured by the fixed effects) along with 95% CIs.||.156|-.686|.209
72477905|NCT04187989|144481591|OTHER|Two-sided test of the null hypothesis of no difference between groups|Cohen's D|-0.107|STANDARD_ERROR_OF_MEAN|0.219||0.623|TWO_SIDED|95.0|-0.541|0.328|||t-test, 2 sided|The p-value is for the coefficient of the treatment/control indicator in the above mixed model|The effect size used is the adjusted Cohen's D, calculated from the coefficient for treatment group in the mixed model, divided by total pooled SD (the square root of the sum of the residual variance+the variance of the group-level random effects)|We fixed linear mixed effects models adjusted for baseline values, balancing factors (age, sex, recreational cannabis), and included a random intercept for group because this is an individually randomized group treatment trial. We tested for treatment effects with a two-sided test of the coefficient for the treatment/control indicator, and estimated Cohen's D (mean difference between the 2 groups at follow-up divided by the total variation not captured by the fixed effects) along with 95% CIs.||.328|-.541|.623
72477906|NCT00092495|144481606|NON_INFERIORITY_OR_EQUIVALENCE|The difference in seroconversion rates (girls - women) must be greater than -5%.|||||<|0.001||95.0|||||Miettinen and Nurminen|"Miettinen and Nurminen method for difference in proportions~Miettinen and Nurminen, Stat Med 1985;4:213-26"||||||<0.001
72477907|NCT00092495|144481606|NON_INFERIORITY_OR_EQUIVALENCE|The difference in seroconversion rates (boys - women) must be greater than -5%.|||||<|0.001||95.0|||||Miettinen and Nurminen|"Miettinen and Nurminen method for difference in proportions~Miettinen and Nurminen, Stat Med 1985;4:213-26"||||||<0.001
72477908|NCT00092495|144481607|NON_INFERIORITY_OR_EQUIVALENCE|The ratio of GMTs (girls/women) must be greater than 0.5.|||||<|0.001||95.0|||||ANOVA|ANOVA on natural log titer with fixed effects for region and comparison group.||||||<0.001
72477909|NCT00092495|144481607|NON_INFERIORITY_OR_EQUIVALENCE|The ratio of GMTs (boys/women) must be greater than 0.5.|||||<|0.001||95.0|||||ANOVA|ANOVA on natural log titer with fixed effects for region and comparison group.||||||<0.001
72477910|NCT00092495|144481608|NON_INFERIORITY_OR_EQUIVALENCE|The difference in seroconversion rates (partial dose - full dose) must be greater than -5%.|||||<|0.001||95.0|||||Miettinen and Nurminen|"Miettinen and Nurminen method for difference in proportions~Miettinen and Nurminen, Stat Med 1985;4:213-26"||||||<0.001
72477911|NCT00092495|144481608|NON_INFERIORITY_OR_EQUIVALENCE|The difference in seroconversion rates (partial dose - full dose) must be greater than -5%.|||||<|0.001||95.0|||||Miettinen and Nurminen|"Miettinen and Nurminen method for difference in proportions~Miettinen and Nurminen, Stat Med 1985;4:213-26"||||||<0.001
72508899|NCT00418262|144548221|SUPERIORITY||Mean Difference (Net)|-2.44|||||TWO_SIDED|95.0|-3.03|-1.9|||||This is the (growth) model-estimated mean difference between visit 1 and visit 10. This estimate utilizes imputed values for missing observations.|"Tested single-group change over time from baseline (visit 1) to the study endpoint (visit 10). The null hypothesis stated that there was no change in PSE ratings over time. Bayesian growth curve models were estimated using Markov Chain Monte Carlo techniques. Several linear and nonlinear trajectory models were compared on fit to data. Mean differences and confidence intervals were generated from the posterior-predictive distribution of the best fitting growth model."||-1.90|-3.03|
72566422|NCT02697773|144663270|SUPERIORITY||Least Square Mean Difference|-0.91|STANDARD_ERROR_OF_MEAN|0.22|<|0.0001|TWO_SIDED|95.0|-1.33|-0.49|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline diary average pain as covariate, and study site as a random effect.||-0.49|-1.33|<.0001
72566423|NCT02697773|144663270|SUPERIORITY||Least Square Mean Difference|-0.94|STANDARD_ERROR_OF_MEAN|0.21|<|0.0001|TWO_SIDED|95.0|-1.36|-0.52|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline diary average pain as covariate, and study site as a random effect.||-0.52|-1.36|<.0001
72477912|NCT00092495|144481608|NON_INFERIORITY_OR_EQUIVALENCE|The difference in seroconversion rates (partial dose - full dose) must be greater than -5%.|||||<|0.001||95.0|||||Miettinen and Nurminen|"Miettinen and Nurminen method for difference in proportions~Miettinen and Nurminen, Stat Med 1985;4:213-26"||||||<0.001
72477913|NCT00092495|144481609|NON_INFERIORITY_OR_EQUIVALENCE|The ratio of GMTs (partial dose/full dose) must be greater than 0.5.|||||<|0.001||95.0|||||ANOVA|ANOVA on natural log titer with fixed effects for region and comparison group.||||||<0.001
72477914|NCT00092495|144481609|NON_INFERIORITY_OR_EQUIVALENCE|The ratio of GMTs (partial dose/full dose) must be greater than 0.5.|||||<|0.001||95.0|||||ANOVA|ANOVA on natural log titer with fixed effects for region and comparison group.||||||<0.001
72477915|NCT00092495|144481609|NON_INFERIORITY_OR_EQUIVALENCE|The ratio of GMTs (partial dose/full dose) must be greater than 0.5.|||||<|0.001||95.0|||||ANOVA|ANOVA on natural log titer with fixed effects for region and comparison group.||||||<0.001
72477916|NCT00092495|144481610|NON_INFERIORITY_OR_EQUIVALENCE|The difference in seroconversion rates (girls - women) must be greater than -5%.|||||<|0.001||95.0|||||Miettinen and Nurminen|"Miettinen and Nurminen method for difference in proportions~Miettinen and Nurminen, Stat Med 1985;4:213-26"||||||<0.001
72477917|NCT00092495|144481610|NON_INFERIORITY_OR_EQUIVALENCE|The difference in seroconversion rates (boys - women) must be greater than -5%.|||||<|0.001||95.0|||||Miettinen and Nurminen|"Miettinen and Nurminen method for difference in proportions~Miettinen and Nurminen, Stat Med 1985;4:213-26"||||||<0.001
72477918|NCT00092495|144481611|NON_INFERIORITY_OR_EQUIVALENCE|The ratio of GMTs (girls/women) must be greater than 0.5.|||||<|0.001||95.0|||||ANOVA|ANOVA on natural log titer with fixed effects for region and comparison group||||||<0.001
72477919|NCT00092495|144481611|NON_INFERIORITY_OR_EQUIVALENCE|The ratio of GMTs (boys/women) must be greater than 0.5.|||||<|0.001||95.0|||||ANOVA|ANOVA on natural log titer with fixed effects for region and comparison group||||||<0.001
72477920|NCT00092495|144481612|NON_INFERIORITY_OR_EQUIVALENCE|The difference in seroconversion rates (partial dose - full dose) must be greater than -5%.|||||<|0.001||95.0|||||Miettinen and Nurminen|"Miettinen and Nurminen method for difference in proportions~Miettinen and Nurminen, Stat Med 1985;4:213-26"||||||<0.001
72477921|NCT00092495|144481612|NON_INFERIORITY_OR_EQUIVALENCE|The difference in seroconversion rates (partial dose - full dose) must be greater than -5%.|||||<|0.001||95.0|||||Miettinen and Nurminen|"Miettinen and Nurminen method for difference in proportions~Miettinen and Nurminen, Stat Med 1985;4:213-26"||||||<0.001
72477922|NCT00092495|144481612|NON_INFERIORITY_OR_EQUIVALENCE|The difference in seroconversion rates (partial dose - full dose) must be greater than -5%.|||||<|0.001||95.0|||||Miettinen and Nurminen|"Miettinen and Nurminen method for difference in proportions~Miettinen and Nurminen, Stat Med 1985;4:213-26"||||||<0.001
72477923|NCT00092495|144481613|NON_INFERIORITY_OR_EQUIVALENCE|The ratio of GMTs (partial dose/full dose) must be greater than 0.5.|||||<|0.001||95.0|||||ANOVA|ANOVA on natural log titer with fixed effects for region and comparison group.||||||<0.001
72477924|NCT00092495|144481613|NON_INFERIORITY_OR_EQUIVALENCE|The ratio of GMTs (partial dose/full dose) must be greater than 0.5.|||||<|0.001||95.0|||||ANOVA|ANOVA on natural log titer with fixed effects for region and comparison group||||||<0.001
72477925|NCT00092495|144481613|NON_INFERIORITY_OR_EQUIVALENCE|The ratio of GMTs (partial dose/full dose) must be greater than 0.5.|||||<|0.001||95.0|||||ANOVA|ANOVA on natural log titer with fixed effects for region and comparison group.||||||<0.001
72477926|NCT00092495|144481614|NON_INFERIORITY_OR_EQUIVALENCE|The difference in seroconversion rates (girls - women) must be greater than -5%.|||||<|0.001||95.0|||||Miettinen and Nurminen|"Miettinen and Nurminen method for difference in proportions~Miettinen and Nurminen, Stat Med 1985;4:213-26"||||||<0.001
72477927|NCT00092495|144481614|NON_INFERIORITY_OR_EQUIVALENCE|The difference in seroconversion rates (boys - women) must be greater than -5%.|||||<|0.001||95.0|||||Miettinen and Nurminen|"Miettinen and Nurminen method for difference in proportions~Miettinen and Nurminen, Stat Med 1985;4:213-26"||||||<0.001
72477928|NCT00092495|144481615|NON_INFERIORITY_OR_EQUIVALENCE|The ratio of GMTs (girls/women) must be greater than 0.5.|||||<|0.001||95.0|||||ANOVA|ANOVA on natural log titer with fixed effects for region and comparison group.||||||<0.001
72477929|NCT00092495|144481615|NON_INFERIORITY_OR_EQUIVALENCE|The ratio of GMTs (boys/women) must be greater than 0.5.|||||<|0.001||95.0|||||ANOVA|ANOVA on natural log titer with fixed effects for region and comparison group.||||||<0.001
72477930|NCT00092495|144481616|NON_INFERIORITY_OR_EQUIVALENCE|The difference in seroconversion rates (partial dose - full dose) must be greater than -5%.|||||<|0.01||95.0|||||Miettinen and Nurminen|"Miettinen and Nurminen method for difference in proportions~Miettinen and Nurminen, Stat Med 1985;4:213-26"||||||<0.01
72477931|NCT00092495|144481616|NON_INFERIORITY_OR_EQUIVALENCE|The difference in seroconversion rates (partial dose - full dose) must be greater than -5%.|||||<|0.001||95.0|||||Miettinen and Nurminen|"Miettinen and Nurminen method for difference in proportions~Miettinen and Nurminen, Stat Med 1985;4:213-26"||||||<0.001
72477932|NCT00092495|144481616|NON_INFERIORITY_OR_EQUIVALENCE|The difference in seroconversion rates (partial dose - full dose) must be greater than -5%.|||||<|0.001||95.0|||||Miettinen and Nurminen|"Miettinen and Nurminen method for difference in proportions~Miettinen and Nurminen, Stat Med 1985;4:213-26"||||||<0.001
72477933|NCT00092495|144481617|NON_INFERIORITY_OR_EQUIVALENCE|The ratio of GMTs (partial dose/full dose) must be greater than 0.5.|||||<|0.001||95.0|||||ANOVA|ANOVA on natural log titer with fixed effects for region and comparison group.||||||<0.001
72477934|NCT00092495|144481617|NON_INFERIORITY_OR_EQUIVALENCE|The ratio of GMTs (partial dose/full dose) must be greater than 0.5.|||||<|0.001||95.0|||||ANOVA|ANOVA on natural log titer with fixed effects for region and comparison group.||||||<0.001
72508900|NCT00418262|144548222|SUPERIORITY||Mean Difference (Net)|0.39|||||TWO_SIDED|95.0|-0.69|1.38|||||This is the (growth) model-estimated mean difference between visit 1 and visit 8. This estimate utilizes imputed values for missing observations.|"Tested single-group change over time from baseline (visit 1) to the study endpoint (visit 10). The null hypothesis stated that there was no change in PSE ratings over time. Bayesian growth curve models were estimated using Markov Chain Monte Carlo techniques. Several linear and nonlinear trajectory models were compared on fit to data. Mean differences and confidence intervals were generated from the posterior-predictive distribution of the best fitting growth model."||1.38|-0.69|
72477935|NCT00092495|144481617|NON_INFERIORITY_OR_EQUIVALENCE|The ratio of GMTs (partial dose/full dose) must be greater than 0.5.|||||<|0.001||95.0|||||ANOVA|ANOVA on natural log titer with fixed effects for region and comparison group.||||||<0.001
72477936|NCT00092495|144481618|NON_INFERIORITY_OR_EQUIVALENCE|The difference in seroconversion rates (girls - women) must be greater than -5%.|||||<|0.001||95.0|||||Miettinen and Nurminen|"Miettinen and Nurminen method for difference in proportions~Miettinen and Nurminen, Stat Med 1985;4:213-26"||||||<0.001
72477937|NCT00092495|144481618|NON_INFERIORITY_OR_EQUIVALENCE|The difference in seroconversion rates (boys - women) must be greater than -5%.|||||<|0.001||95.0|||||Miettinen and Nurminen|"Miettinen and Nurminen method for difference in proportions~Miettinen and Nurminen, Stat Med 1985;4:213-26"||||||<0.001
72477938|NCT00092495|144481619|NON_INFERIORITY_OR_EQUIVALENCE|The ratio of GMTs (girls/women) must be greater than 0.5.|||||<|0.001||95.0|||||ANOVA|ANOVA on natural log titer with fixed effects for region and comparison group.||||||<0.001
72477939|NCT00092495|144481619|NON_INFERIORITY_OR_EQUIVALENCE|The ratio of GMTs (boys/women) must be greater than 0.5.|||||<|0.001||95.0|||||ANOVA|ANOVA on natural log titer with fixed effects for region and comparison group.||||||<0.001
72477940|NCT00092495|144481620|NON_INFERIORITY_OR_EQUIVALENCE|The difference in seroconversion rates (partial dose - full dose) must be greater than -5%.|||||<|0.001||95.0|||||Miettinen and Nurminen|"Miettinen and Nurminen method for difference in proportions~Miettinen and Nurminen, Stat Med 1985;4:213-26"||||||<0.001
72477941|NCT00092495|144481620|NON_INFERIORITY_OR_EQUIVALENCE|The difference in seroconversion rates (partial dose - full dose) must be greater than -5%.|||||<|0.001||95.0|||||Miettinen and Nurminen|"Miettinen and Nurminen method for difference in proportions~Miettinen and Nurminen, Stat Med 1985;4:213-26"||||||<0.001
72477942|NCT00092495|144481620|NON_INFERIORITY_OR_EQUIVALENCE|The difference in seroconversion rates (partial dose - full dose) must be greater than -5%.|||||<|0.001||95.0|||||Miettinen and Nurminen|"Miettinen and Nurminen method for difference in proportions~Miettinen and Nurminen, Stat Med 1985;4:213-26"||||||<0.001
72477943|NCT00092495|144481621|NON_INFERIORITY_OR_EQUIVALENCE|The ratio of GMTs (partial dose/full dose) must be greater than 0.5.|||||<|0.001||95.0|||||ANOVA|ANOVA on natural log titer with fixed effects for region and comparison group.||||||<0.001
72477944|NCT00092495|144481621|NON_INFERIORITY_OR_EQUIVALENCE|The ratio of GMTs (partial dose/full dose) must be greater than 0.5.|||||<|0.001||95.0|||||ANOVA|ANOVA on natural log titer with fixed effects for region and comparison group.||||||<0.001
72477945|NCT00092495|144481621|NON_INFERIORITY_OR_EQUIVALENCE|The ratio of GMTs (partial dose/full dose) must be greater than 0.5.|||||<|0.001||95.0|||||ANOVA|ANOVA on natural log titer with fixed effects for region and comparison group.||||||<0.001
72477946|NCT02630693|144481631|OTHER|As stated in the protocol, the primary objective of this trial is to estimate the hazard ratio and the corresponding 90% confidence interval. Therefore, we do not conduct any statistical hypothesis test for progression free survival.|Hazard Ratio (HR)|0.93|||||TWO_SIDED|90.0|0.66|1.3|||||Hazard ratio of Palbociclib100mg arm vs 125 mg arm|||1.30|0.66|
72566424|NCT02697773|144663270|SUPERIORITY||Least Square Mean Difference|-0.72|STANDARD_ERROR_OF_MEAN|0.23||0.0015|TWO_SIDED|95.0|-1.16|-0.28|||ANCOVA|||Week 6: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline diary average pain as covariate, and study site as a random effect.||-0.28|-1.16|0.0015
72566425|NCT02697773|144663270|SUPERIORITY||Least Square Mean Difference|-0.68|STANDARD_ERROR_OF_MEAN|0.22||0.0023|TWO_SIDED|95.0|-1.12|-0.24|||ANCOVA|||Week 6: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline diary average pain as covariate, and study site as a random effect.||-0.24|-1.12|0.0023
72623381|NCT00323622|144777536|SUPERIORITY_OR_OTHER||1 - (R1/R2)|19.42||||0.01|TWO_SIDED|95.0|4.62|31.93||The p-value presented is the Wald Chi-square p-value from the Cox regression model.|Regression, Cox|Point estimate of efficacy was adjusted for age, geographical area of residence, bednet use and distance from health center.||The analysis aimed to compare rates of first PFMI (RPFMI) between groups over the Months 21-33 time period. Using RFPMI, a Cox model was used to evaluate vaccine efficacy (VE) allowing for adjustment factors. VE, point estimate of efficacy adjusted for covariates, was calculated as 1 - (minus) \[Hazard Ratio (HR) in Cohort 1 - RTS,S/AS02A Group \[HR1\]) divided by HR in Cohort 1 - Engerix-B/Prevnar-Hiberix Group \[HR2\])\], i. e. 1 - (HR1/HR2).||31.93|4.62|0.01
72477947|NCT02630693|144481634|OTHER|As stated in the protocol, the objective of this trial is to estimate the hazard ratio and the corresponding 90% confidence interval. Therefore, we do not conduct any statistical hypothesis test for overall survival.|Hazard Ratio (HR)|1.07|||||TWO_SIDED|90.0|0.67|1.69|||||Hazard ratio for Palbociclib 100mg arm vs 125 mg arm|||1.69|0.67|
72477948|NCT04601870|144481635|SUPERIORITY||Odds Ratio (OR)|1.5||||0.4137|TWO_SIDED|95.0|0.566|3.973|||Chi-squared|Chi squared equals 0.668 with 1 degrees of freedom|Odds ratio for completing counseling in $50 arm vs. $0 arm|||3.973|.566|0.4137
72477949|NCT04601870|144481635|SUPERIORITY||Odds Ratio (OR)|1.5||||0.4137|TWO_SIDED|95.0|0.566|3.973|||Chi-squared|Chi squared equals 0.668 with 1 degrees of freedom|Odds ratio for completing counseling in $100 arm vs. $0 arm|||3.973|.566|0.4137
72477950|NCT04601870|144481635|SUPERIORITY||Odds Ratio (OR)|1.5||||0.3383|TWO_SIDED|95.0|0.653|3.446|||Chi-squared|Chi squared equals 0.917 with 1 degrees of freedom|Odds ratio for completing counseling in $50 or $100 arm vs. $0 arm|$0 vs. $50 or $100||3.446|.653|.3383
72477951|NCT04601870|144481636|SUPERIORITY||Odds Ratio (OR)|2.333||||0.265|TWO_SIDED|95.0|0.51|10.6751|||Chi-squared|Chi squared equals 1.243 with 1 degrees of freedom|Odds ratio for achieving confirmed abstinence at 6 months post-tqd in $50 arm vs. $0 arm|||10.6751|.5100|.2650
72477952|NCT04601870|144481636|SUPERIORITY||Odds Ratio (OR)|0.8333||||0.8472|TWO_SIDED|95.0|0.1301|5.3369|||Chi-squared|Chi squared equals 0.037 with 1 degrees of freedom|Odds ratio for achieving confirmed abstinence at 6 months post-tqd in $100 arm vs. $0 arm|||5.3369|.1301|.8472
72477953|NCT04601870|144481636|SUPERIORITY||Odds Ratio (OR)|1.541||||0.5478|TWO_SIDED|95.0|0.3731|6.364|||Chi-squared|Chi squared equals 0.361 with 1 degrees of freedom|Odds ratio for achieving confirmed abstinence at 6 months post-tqd in $50 or $100 arms vs. $0 arm|$0 vs. $50 or $100||6.3640|.3731|.5478
72477954|NCT04601870|144481636|SUPERIORITY||Odds Ratio (OR)|0.3571||||0.2276|TWO_SIDED|95.0|0.06355|2.007|||Chi-squared|Chi squared equals 1.456 with 1 degrees of freedom|Odds ratio for achieving confirmed abstinence at 6 months post-tqd in $100 arm vs. $50 arm|||2.0070|.06355|.2276
72399843|NCT00518323|144307304|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.1|STANDARD_ERROR_OF_MEAN|3.17||0.508||95.0|-8.36|4.16||The p value was associated with the closed testing procedure using Dunnett's test.|ANCOVA|Used ANCOVA model with treatment(placebo, pali ER Low, pali ER Medium, and pali ER High) and country as factors and baseline value as a covariate.|The 95% confidence intervals were unadjusted for multiplicity.|If there were approximately 49 subjects per treatment group who had Week 6 (LOCF or end point) PANSS total measurements, the study was expected to have approximately 80% power to detect a clinically relevant difference of 13.2 points between any paliperidone ER group compared with placebo for the primary outcome measure.||4.16|-8.36|0.508
72477955|NCT03932812|144481638|SUPERIORITY||Mean Difference (Net)|1.128|STANDARD_ERROR_OF_MEAN|1.622||0.206|TWO_SIDED||||||Regression, Linear|We used generalized estimating equations to fit linear regression model for longitudinal data under the unstructured correlation matrix.|Estimated value: presented value is mean difference at month 6 from BL. Information from month 3 is included in the linear regression model. The reported p-value is the significance of the interaction effect between time and the intervention.|||||0.206
72477956|NCT03932812|144481639|SUPERIORITY||Mean Difference (Final Values)|2.376|STANDARD_ERROR_OF_MEAN|1.793||0.101|TWO_SIDED||||||Regression, Linear|We used generalized estimating equations to fit linear regression model for longitudinal data under the unstructured correlation matrix.|Estimated value: presented value is mean difference at month 6 from BL. Information from month 3 is included in the linear regression model. The reported p-value is the significance of the interaction effect between time and the intervention.|||||0.101
72477957|NCT03932812|144481640|SUPERIORITY||Mean Difference (Net)|-0.201|STANDARD_ERROR_OF_MEAN|1.174||0.836|TWO_SIDED||||||Regression, Linear|We used generalized estimating equations to fit linear regression model for longitudinal data under the unstructured correlation matrix.|Estimated value: presented value is mean difference at month 6 from BL. Information from month 3 is included in the linear regression model. The reported p-value is the significance of the interaction effect between time and the intervention.|||||0.836
72477958|NCT03932812|144481641|SUPERIORITY||Mean Difference (Final Values)|0.117|STANDARD_ERROR_OF_MEAN|0.414||0.567|TWO_SIDED||||||Chi-squared||Estimated value: presented value is for month 6. Since the outcome measure is count data, a log link function is used. The reported p-value is the significance of the interaction effect between time and intervention.|The outcome for this analyses is use of emergency care.||||0.567
72477959|NCT03932812|144481642|SUPERIORITY||Mean Difference (Final Values)|-0.363|STANDARD_ERROR_OF_MEAN|0.165||0.014|TWO_SIDED||||||Chi-squared||Estimated value: presented value is for month 6. Since the outcome measure is count data, a log link function is used. The reported p-value is the significance of the interaction effect between time and intervention.|||||0.014
72477960|NCT03932812|144481643|SUPERIORITY||Mean Difference (Final Values)|0.467|STANDARD_ERROR_OF_MEAN|0.301||0.01|TWO_SIDED||||||Chi-squared||Estimated value: presented value is for month 6. Since the outcome measure is count data, a log link function is used. The reported p-value is the significance of the interaction effect between time and intervention.|||||0.010
72566426|NCT02697773|144663270|SUPERIORITY||Least Square Mean Difference|-0.44|STANDARD_ERROR_OF_MEAN|0.23||0.0512|TWO_SIDED|95.0|-0.89|0.0|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline diary average pain as covariate, and study site as a random effect.||0.00|-0.89|0.0512
72566427|NCT02697773|144663270|SUPERIORITY||Least Square Mean Difference|-0.41|STANDARD_ERROR_OF_MEAN|0.22||0.0693|TWO_SIDED|95.0|-0.85|0.03|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline diary average pain as covariate, and study site as a random effect.||0.03|-0.85|0.0693
72566428|NCT02697773|144663270|SUPERIORITY||Least Square Mean Difference|-0.68|STANDARD_ERROR_OF_MEAN|0.24||0.0043|TWO_SIDED|95.0|-1.14|-0.21|||ANCOVA|||Week 10: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline diary average pain as covariate, and study site as a random effect.||-0.21|-1.14|0.0043
72566429|NCT02697773|144663270|SUPERIORITY||Least Square Mean Difference|-0.67|STANDARD_ERROR_OF_MEAN|0.23||0.0041|TWO_SIDED|95.0|-1.13|-0.21|||ANCOVA|||Week 10: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline diary average pain as covariate, and study site as a random effect.||-0.21|-1.13|0.0041
72566430|NCT02697773|144663270|SUPERIORITY||Least Square Mean Difference|-0.73|STANDARD_ERROR_OF_MEAN|0.24||0.0024|TWO_SIDED|95.0|-1.19|-0.26|||ANCOVA|||Week 12: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline diary average pain as covariate, and study site as a random effect.||-0.26|-1.19|0.0024
72566431|NCT02697773|144663270|SUPERIORITY||Least Square Mean Difference|-0.75|STANDARD_ERROR_OF_MEAN|0.24||0.0015|TWO_SIDED|95.0|-1.22|-0.29|||ANCOVA|||Week 12: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline diary average pain as covariate, and study site as a random effect.||-0.29|-1.22|0.0015
72566432|NCT02697773|144663270|SUPERIORITY||Least Square Mean Difference|-0.67|STANDARD_ERROR_OF_MEAN|0.25||0.0063|TWO_SIDED|95.0|-1.16|-0.19|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline diary average pain as covariate, and study site as a random effect.||-0.19|-1.16|0.0063
72477961|NCT03932812|144481644|SUPERIORITY||Mean Difference (Net)|2.11|STANDARD_ERROR_OF_MEAN|2.682||0.188|TWO_SIDED||||||Regression, Linear|We used generalized estimating equations to fit linear regression model for longitudinal data under the unstructured correlation matrix.|Estimated value: presented value is mean difference at month 6 from BL. Information from month 3 is included in the linear regression model. The reported p-value is the significance of the interaction effect between time and the intervention.|||||0.188
72477962|NCT04193436|144481645|OTHER||Ratio (%) of Adjusted Means|92.89|||||TWO_SIDED|90.0|68.15|126.6||||||The effect of the hepatic impairment on PK parameter AUCinf were assessed by constructing 90% confidence intervals around the estimated difference between each of the Test (impaired) cohorts and the Reference (without hepatic impairment) cohort using a one-way analysis of variance (ANOVA) model based on natural log transformed data.||126.60|68.15|
72477963|NCT04193436|144481645|OTHER||Ratio (%) of Adjusted Means|134.4|||||TWO_SIDED|90.0|98.61|183.17||||||The effect of the hepatic impairment on PK parameter AUCinf were assessed by constructing 90% confidence intervals around the estimated difference between each of the Test (impaired) cohorts and the Reference (without hepatic impairment) cohort using a one-way ANOVA model based on natural log transformed data.||183.17|98.61|
72477964|NCT04193436|144481645|OTHER||Ratio (%) of Adjusted Means|139.33|||||TWO_SIDED|90.0|100.69|192.78||||||The effect of the hepatic impairment on PK parameter AUCinf were assessed by constructing 90% confidence intervals around the estimated difference between each of the Test (impaired) cohorts and the Reference (without hepatic impairment) cohort using a one-way ANOVA model based on natural log transformed data.||192.78|100.69|
72477965|NCT04193436|144481646|OTHER||Ratio (%) of Adjusted Means|87.2|||||TWO_SIDED|90.0|63.61|119.53||||||The effect of the hepatic impairment on PK parameter Cmax were assessed by constructing 90% confidence intervals around the estimated difference between each of the Test (impaired) cohorts and the Reference (without hepatic impairment) cohort using a one-way ANOVA model based on natural log transformed data.||119.53|63.61|
72477966|NCT04193436|144481646|OTHER||Ratio (%) of Adjusted Means|102.24|||||TWO_SIDED|90.0|74.59|140.15||||||The effect of the hepatic impairment on PK parameter Cmax were assessed by constructing 90% confidence intervals around the estimated difference between each of the Test (impaired) cohorts and the Reference (without hepatic impairment) cohort using a one-way ANOVA model based on natural log transformed data.||140.15|74.59|
72477967|NCT04193436|144481646|OTHER||Ratio (%) of Adjusted Means|83.78|||||TWO_SIDED|90.0|60.18|116.62||||||The effect of the hepatic impairment on PK parameter Cmax were assessed by constructing 90% confidence intervals around the estimated difference between each of the Test (impaired) cohorts and the Reference (without hepatic impairment) cohort using a one-way ANOVA model based on natural log transformed data.||116.62|60.18|
72477968|NCT04193436|144481647|OTHER||Ratio (%) of Adjusted Means|121.81|||||TWO_SIDED|90.0|88.69|167.31||||||The effect of the hepatic impairment on PK parameter AUCinf,u were assessed by constructing 90% confidence intervals around the estimated difference between each of the Test (impaired) cohorts and the Reference (without hepatic impairment) cohort using a one-way ANOVA model based on natural log transformed data.||167.31|88.69|
72508901|NCT00418262|144548222|SUPERIORITY||Mean Difference (Net)|0.39|||||TWO_SIDED|95.0|-0.69|1.38|||||This is the (growth) model-estimated mean difference between visit 1 and visit 10. This estimate utilizes imputed values for missing observations.|"Tested single-group change over time from baseline (visit 1) to the study endpoint (visit 10). The null hypothesis stated that there was no change in PSE ratings over time. Bayesian growth curve models were estimated using Markov Chain Monte Carlo techniques. Several linear and nonlinear trajectory models were compared on fit to data. Mean differences and confidence intervals were generated from the posterior-predictive distribution of the best fitting growth model."||1.38|-0.69|
72477969|NCT04193436|144481647|OTHER||Ratio (%) of Adjusted Means|178.5|||||TWO_SIDED|90.0|129.96|245.18||||||The effect of the hepatic impairment on PK parameter AUCinf,u were assessed by constructing 90% confidence intervals around the estimated difference between each of the Test (impaired) cohorts and the Reference (without hepatic impairment) cohort using a one-way ANOVA model based on natural log transformed data.||245.18|129.96|
72477970|NCT04193436|144481647|OTHER||Ratio (%) of Adjusted Means|195.73|||||TWO_SIDED|90.0|140.31|273.03||||||The effect of the hepatic impairment on PK parameter AUCinf,u were assessed by constructing 90% confidence intervals around the estimated difference between each of the Test (impaired) cohorts and the Reference (without hepatic impairment) cohort using a one-way ANOVA model based on natural log transformed data.||273.03|140.31|
72477971|NCT04193436|144481648|OTHER||Ratio (%) of Adjusted Means|114.45|||||TWO_SIDED|90.0|88.13|148.63||||||The effect of the hepatic impairment on PK parameter Cmax,u were assessed by constructing 90% confidence intervals around the estimated difference between each of the Test (impaired) cohorts and the Reference (without hepatic impairment) cohort using a one-way ANOVA model based on natural log transformed data.||148.63|88.13|
72477972|NCT04193436|144481648|OTHER||Ratio (%) of Adjusted Means|136.04|||||TWO_SIDED|90.0|104.75|176.67||||||The effect of the hepatic impairment on PK parameter Cmax,u were assessed by constructing 90% confidence intervals around the estimated difference between each of the Test (impaired) cohorts and the Reference (without hepatic impairment) cohort using a one-way ANOVA model based on natural log transformed data.||176.67|104.75|
72477973|NCT04193436|144481648|OTHER||Ratio (%) of Adjusted Means|117.87|||||TWO_SIDED|90.0|89.61|155.03||||||The effect of the hepatic impairment on PK parameter Cmax,u were assessed by constructing 90% confidence intervals around the estimated difference between each of the Test (impaired) cohorts and the Reference (without hepatic impairment) cohort using a one-way ANOVA model based on natural log transformed data.||155.03|89.61|
72477974|NCT02585232|144481653|SUPERIORITY|||||||0.483|||||||ANCOVA|Caregiver education, cognitive status of the person with dementia, and baseline caregiver burden scores were included in the model as covariates.||||||.483
72477975|NCT02585232|144481654|SUPERIORITY|||||||0.169|||||||ANCOVA|Caregiver education, cognitive status of the person with dementia, and baseline Dyadic Adjustment Scale scores were included as covariates.||Only caregivers that were currently or previously in a romantic relationship (e.g., spouses, partners) with the person with dementia reported on the Dyadic Adjustment Scale (i.e., N = 20, n = 9 in CC group and n = 11 in CC+C group).||||0.169
72477976|NCT02585232|144481655|SUPERIORITY|||||||0.763|||||||ANCOVA|Baseline quality of life scores, education, and cognitive status were included as covariates in the model.||||||0.763
72477977|NCT02585232|144481656|SUPERIORITY|||||||0.78|||||||ANCOVA|Baseline depression scores, cognitive status scores (i.e., MoCA), and education were included in the model as covariates.||||||0.780
72477978|NCT02313233|144481662|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||t-test, 1 sided|||||||<0.05
72477979|NCT02313233|144481663|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||t-test, 1 sided|||||||<0.05
72477980|NCT02313233|144481666|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||t-test, 1 sided|||||||<0.05
72477981|NCT02313233|144481667|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||t-test, 1 sided|||||||<0.05
72477982|NCT02679573|144481688|NON_INFERIORITY|Used on a normal approximation approach (Miettinen and Nurminen's Likelihood Score Test), 860 subjects in the ITT population provided a 90% power to assess non-inferiority of delafloxacin vs. moxifloxacin based on the following assumptions: (1) a rate of ECR for moxifloxacin therapy and delafloxacin of 77% and 74%, respectively; (2) 1 sided type I error (α) of 0.025; and (3) a non-inferiority margin of 12.5%.|Difference in responder rates|-0.2|||||TWO_SIDED|95.0|-4.4|4.1|||||Difference = Difference in responder rates (Delafloxacin treatment group minus Moxifloxacin treatment group). Confidence intervals are calculated using Miettinen and Nurminen method without stratification.|"The null (H0) and alternative (Ha) hypotheses to be tested to establish the noninferiority of delafloxacin were:~H0: Pd - Pm ≤ -0.125 Ha: Pd - Pm \> -0.125 where Pd and Pm are the probabilities of the ECR for delafloxacin and moxifloxacin, respectively.~The treatment difference (delafloxacin - moxifloxacin) were presented, and the Miettinen-Nurminen test, without stratification, was used for the 2 sided 95% CI on the difference in response rate."||4.1|-4.4|
72508902|NCT02650284|144548224|EQUIVALENCE|Equivalence defined as less than or equal to 1 standard deviation between the two means.||||||0.46||||||The number of recruited patients did not reach the required sample size. Power score assessments no longer hold, thus there is low confidence in the findings.|t-test, 2 sided|||Comparison between groups at pre-operation timepoint.||||0.46
72508903|NCT02650284|144548224|EQUIVALENCE|Equivalence defined as less than or equal to 1 standard deviation between the two means.||||||0.23||||||The number of recruited patients did not reach the required sample size. Power score assessments no longer hold, thus there is low confidence in the findings.|t-test, 2 sided|||Comparison between groups at 6-week timepoint.||||0.23
72508904|NCT02650284|144548224|EQUIVALENCE|Equivalence defined as less than or equal to 1 standard deviation between the two means.||||||0.1||||||The number of recruited patients did not reach the required sample size. Power score assessments no longer hold, thus there is low confidence in the findings.|t-test, 2 sided|||Comparison between groups at 3-month timepoint.||||0.10
72508905|NCT02650284|144548224|EQUIVALENCE|Equivalence defined as less than or equal to 1 standard deviation between the two means.||||||0.98||||||The number of recruited patients did not reach the required sample size. Power score assessments no longer hold, thus there is low confidence in the findings.|t-test, 2 sided|||Comparison between groups at 12-month timepoint.||||0.98
72508906|NCT02650284|144548224|EQUIVALENCE|Equivalence defined as less than or equal to 1 standard deviation between the two means.||||||0.5||||||The number of recruited patients did not reach the required sample size. Power score assessments no longer hold, thus there is low confidence in the findings.|t-test, 2 sided|||Comparison between groups at 24-month timepoint.||||0.50
72508907|NCT02650284|144548225|EQUIVALENCE|Equivalence defined as less than or equal to 1 standard deviation between the two means.||||||0.59||||||The number of recruited patients did not reach the required sample size. Power score assessments no longer hold, thus there is low confidence in the findings.|t-test, 2 sided|||To compare EQ-5D Index preoperatively between both groups.||||0.59
72508908|NCT02650284|144548225|EQUIVALENCE|Equivalence defined as less than or equal to 1 standard deviation between the two means.||||||0.9||||||The number of recruited patients did not reach the required sample size. Power score assessments no longer hold, thus there is low confidence in the findings.|t-test, 2 sided|||To compare EQ-5D index at 3-months between both groups.||||0.90
72508909|NCT02650284|144548225|EQUIVALENCE|Equivalence defined as less than or equal to 1 standard deviation between the two means.||||||0.57||||||The number of recruited patients did not reach the required sample size. Power score assessments no longer hold, thus there is low confidence in the findings.|t-test, 2 sided|||To compare EQ-5D index at 12-months between both groups.||||0.57
72508910|NCT02650284|144548225|EQUIVALENCE|Equivalence defined as less than or equal to 1 standard deviation between the two means.||||||0.49||||||The number of recruited patients did not reach the required sample size. Power score assessments no longer hold, thus there is low confidence in the findings.|t-test, 2 sided|||To compare EQ-5D index at 24-months between both groups.||||0.49
72508911|NCT02650284|144548225|EQUIVALENCE|Equivalence defined as less than or equal to 1 standard deviation between the two means||||||0.65||||||The number of recruited patients did not reach the required sample size. Power score assessments no longer hold, thus there is low confidence in the findings.|t-test, 2 sided|||To compare EQ-5D VAS preoperatively between both groups.||||0.65
72508912|NCT02650284|144548225|EQUIVALENCE|Equivalence defined as less than or equal to 1 standard deviation between the two means.||||||0.3||||||The number of recruited patients did not reach the required sample size. Power score assessments no longer hold, thus there is low confidence in the findings.|t-test, 2 sided|||To compare EQ-5D VAS at 3-months between both groups.||||0.30
72508913|NCT02650284|144548225|EQUIVALENCE|Equivalence defined as less than or equal to 1 standard deviation between the two means.||||||0.06||||||The number of recruited patients did not reach the required sample size. Power score assessments no longer hold, thus there is low confidence in the findings.|t-test, 2 sided|||To compare EQ-5D VAS at 12-months between both groups.||||0.06
72508914|NCT02650284|144548225|EQUIVALENCE|Equivalence defined as less than or equal to 1 standard deviation between the two means.||||||0.44||||||The number of recruited patients did not reach the required sample size. Power score assessments no longer hold, thus there is low confidence in the findings.|t-test, 2 sided|||To compare EQ-5D VAS at 24-months between both groups.||||0.44
72508915|NCT02650284|144548226|EQUIVALENCE|Equivalence defined as less than or equal to 1 standard deviation between the two means.||||||0.97||||||The number of recruited patients did not reach the required sample size. Power score assessments no longer hold, thus there is low confidence in the findings.|t-test, 2 sided|||To compare VAS Pain at Rest preoperatively between both groups.||||0.97
72508916|NCT02650284|144548226|EQUIVALENCE|Equivalence defined as less than or equal to 1 standard deviation between the two means.||||||0.45||||||The number of recruited patients did not reach the required sample size. Power score assessments no longer hold, thus there is low confidence in the findings.|t-test, 2 sided|||To compare VAS Pain at Rest at 3-months between both groups.||||0.45
72399844|NCT00518323|144307304|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.1|STANDARD_ERROR_OF_MEAN|3.27||0.006||95.0|-16.58|-3.67||The p value was associated with the closed testing procedure using Dunnett's test.|ANCOVA|Used ANCOVA model with treatment(placebo, pali ER Low, pali ER Medium, and pali ER High) and country as factors and baseline value as a covariate.|The 95% confidence intervals were unadjusted for multiplicity.|If there were approximately 49 subjects per treatment group who had Week 6 (LOCF or end point) PANSS total measurements, the study was expected to have approximately 80% power to detect a clinically relevant difference of 13.2 points between any paliperidone ER group compared with placebo for the primary outcome measure.||-3.67|-16.58|0.006
72399845|NCT00518323|144307304|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.6|STANDARD_ERROR_OF_MEAN|3.29||0.086||95.0|-13.07|-0.09||The p value was associated with the closed testing procedure using Dunnett's test.|ANCOVA|Used ANCOVA model with treatment(placebo, pali ER Low, pali ER Medium, and pali ER High) and country as factors and baseline value as a covariate.|The 95% confidence intervals were unadjusted for multiplicity.|If there were approximately 49 subjects per treatment group who had Week 6 (LOCF or end point) PANSS total measurements, the study was expected to have approximately 80% power to detect a clinically relevant difference of 13.2 points between any paliperidone ER group compared with placebo for the primary outcome measure.||-0.09|-13.07|0.086
72399846|NCT00518323|144307305|SUPERIORITY_OR_OTHER|||||||0.968||95.0||||Comparison with placebo was without multiplicity adjustment.|ANCOVA|||Analysis of the change in the CGI-S score at end point was performed using an analysis of covariance model on the ranks of the change in score at end point with treatment (placebo, pali ER Low, pali ER Medium, and pali ER High) and country as factors, and (non-ranked) baseline CGI-S score as a covariate.||||0.968
72399847|NCT00518323|144307305|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Comparison with placebo was without multiplicity adjustment.|ANCOVA|||Analysis of the change in the CGI-S score at end point was performed using an analysis of covariance model on the ranks of the change in score at end point with treatment (placebo, pali ER Low, pali ER Medium, and pali ER High) and country as factors, and (non-ranked) baseline CGI-S score as a covariate.||||<0.001
72399848|NCT00518323|144307305|SUPERIORITY_OR_OTHER|||||||0.021||95.0||||Comparison with placebo was without multiplicity adjustment.|ANCOVA|||Analysis of the change in the CGI-S score at end point was performed using an analysis of covariance model on the ranks of the change in score at end point with treatment (placebo, pali ER Low, pali ER Medium, and pali ER High) and country as factors, and (non-ranked) baseline CGI-S score as a covariate.||||0.021
72399849|NCT00518323|144307306|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|2.1||0.846||95.0|-4.54|3.73||Comparison with placebo was without multiplicity adjustment.|ANCOVA|Used ANCOVA model with treatment (placebo, pali ER Low, pali ER Medium, and pali ER High) and country as factors and baseline value as a covariate.||||3.73|-4.54|0.846
72399850|NCT00518323|144307306|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.6|STANDARD_ERROR_OF_MEAN|2.17|<|0.001||95.0|4.28|12.82||Comparison with placebo was without multiplicity adjustment.|ANCOVA|Used ANCOVA model with treatment(placebo, pali ER Low, pali ER Medium, and pali ER High) and country as factors and baseline value as a covariate.||||12.82|4.28|<0.001
72399851|NCT00518323|144307306|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.0|STANDARD_ERROR_OF_MEAN|2.18||0.067||95.0|-0.28|8.33||Comparison with placebo was without multiplicity adjustment.|ANCOVA|Used ANCOVA model with treatment(placebo, pali ER Low, pali ER Medium, and pali ER High) and country as factors and baseline value as a covariate.||||8.33|-0.28|0.067
72399852|NCT00518323|144307307|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.1|STANDARD_ERROR_OF_MEAN|4.27||0.058||95.0|-0.29|16.56||Comparison with placebo was without multiplicity adjustment.|ANCOVA|Used ANCOVA model with treatment(placebo, pali ER Low, pali ER Medium, and pali ER High) and country as factors and baseline value as a covariate.||||16.56|-0.29|0.058
72399853|NCT00518323|144307307|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.8|STANDARD_ERROR_OF_MEAN|4.4|<|0.001||95.0|8.08|25.43||Comparison with placebo was without multiplicity adjustment.|ANCOVA|Used ANCOVA model with treatment(placebo, pali ER Low, pali ER Medium, and pali ER High) and country as factors and baseline value as a covariate.||||25.43|8.08|<0.001
72399854|NCT00518323|144307307|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.5|STANDARD_ERROR_OF_MEAN|4.43||0.003||95.0|4.76|22.23||Comparison with placebo was without multiplicity adjustment.|ANCOVA|Used ANCOVA model with treatment(placebo, pali ER Low, pali ER Medium, and pali ER High) and country as factors and baseline value as a covariate.||||22.23|4.76|0.003
72477983|NCT02679573|144481689|NON_INFERIORITY|Used on a normal approximation approach (Miettinen and Nurminen's Likelihood Score Test), 860 subjects in the ITT population provided a 90% power to assess non-inferiority of delafloxacin vs. moxifloxacin based on the following assumptions: (1) a rate of ECR for moxifloxacin therapy and delafloxacin of 77% and 74%, respectively; (2) 1 sided type I error (α) of 0.025; and (3) a non-inferiority margin of 12.5%.|Difference in responder rates|9.7|||||TWO_SIDED|95.0|3.0|16.3||||||"The null (H0) and alternative (Ha) hypotheses to be tested to establish the noninferiority of delafloxacin were:~H0: Pd - Pm ≤ -0.125 Ha: Pd - Pm \> -0.125~where Pd and Pm are the probabilities of the ECR for delafloxacin and moxifloxacin, respectively.~The treatment difference (delafloxacin - moxifloxacin) was presented, and the Miettinen-Nurminen test without stratification was used for the 2 sided 95% CI on the difference in response rate."||16.3|3.0|
72477984|NCT02679573|144481690|NON_INFERIORITY|Used on a normal approximation approach (Miettinen and Nurminen's Likelihood Score Test), 860 subjects in the ITT population provided a 90% power to assess non-inferiority of delafloxacin vs. moxifloxacin based on the following assumptions: (1) a rate of ECR for moxifloxacin therapy and delafloxacin of 77% and 74%, respectively; (2) 1 sided type I error (α) of 0.025; and (3) a non-inferiority margin of 12.5%.|Difference in responder rates|0.8|||||TWO_SIDED|95.0|-3.3|4.8||||||"The null (H0) and alternative (Ha) hypotheses to be tested to establish the noninferiority of delafloxacin were:~H0: Pd - Pm ≤ -0.125 Ha: Pd - Pm \> -0.125~where Pd and Pm are the probabilities of the ECR for delafloxacin and moxifloxacin, respectively.~The treatment difference (delafloxacin - moxifloxacin) was presented, and the Miettinen-Nurminen test without stratification was used for the 2 sided 95% CI on the difference in response rate."||4.8|-3.3|
72508917|NCT02650284|144548226|EQUIVALENCE|Equivalence defined as less than or equal to 1 standard deviation between the two means.||||||0.64||||||The number of recruited patients did not reach the required sample size. Power score assessments no longer hold, thus there is low confidence in the findings.|t-test, 2 sided|||To compare VAS Pain at Rest at 12-months between both groups.||||0.64
72477985|NCT02679573|144481691|NON_INFERIORITY|Used on a normal approximation approach (Miettinen and Nurminen's Likelihood Score Test), 860 subjects in the ITT population provided a 90% power to assess non-inferiority of delafloxacin vs. moxifloxacin based on the following assumptions: (1) a rate of ECR for moxifloxacin therapy and delafloxacin of 77% and 74%, respectively; (2) 1 sided type I error (α) of 0.025; and (3) a non-inferiority margin of 12.5%.|Difference in responder rates|0.8|||||TWO_SIDED|95.0|-3.0|4.6||||||"The null (H0) and alternative (Ha) hypotheses to be tested to establish the noninferiority of delafloxacin were:~H0: Pd - Pm ≤ -0.125 Ha: Pd - Pm \> -0.125~where Pd and Pm are the probabilities of the ECR for delafloxacin and moxifloxacin, respectively.~The treatment difference (delafloxacin - moxifloxacin) was presented, and the Miettinen-Nurminen test without stratification was used for the 2 sided 95% CI on the difference in response rate."||4.6|-3.0|
72477986|NCT02679573|144481692|NON_INFERIORITY|Used on a normal approximation approach (Miettinen and Nurminen's Likelihood Score Test), 860 subjects in the ITT population provided a 90% power to assess non-inferiority of delafloxacin vs. moxifloxacin based on the following assumptions: (1) a rate of ECR for moxifloxacin therapy and delafloxacin of 77% and 74%, respectively; (2) 1 sided type I error (α) of 0.025; and (3) a non-inferiority margin of 12.5%.|Difference in responder rates|0.5|||||TWO_SIDED|95.0|-4.8|5.9||||||"The null (H0) and alternative (Ha) hypotheses to be tested to establish the noninferiority of delafloxacin were:~H0: Pd - Pm ≤ -0.125 Ha: Pd - Pm \> -0.125~where Pd and Pm are the probabilities of the ECR for delafloxacin and moxifloxacin, respectively.~The treatment difference (delafloxacin - moxifloxacin) was presented, and the Miettinen-Nurminen test without stratification was used for the 2 sided 95% CI on the difference in response rate."||5.9|-4.8|
72508918|NCT02650284|144548226|EQUIVALENCE|Equivalence defined as less than or equal to 1 standard deviation between the two means.||||||0.19||||||The number of recruited patients did not reach the required sample size. Power score assessments no longer hold, thus there is low confidence in the findings.|t-test, 2 sided|||To compare VAS Pain at Rest at 24-months between both groups.||||0.19
72566433|NCT02697773|144663270|SUPERIORITY||Least Square Mean Difference|-0.82|STANDARD_ERROR_OF_MEAN|0.24||0.0008|TWO_SIDED|95.0|-1.3|-0.34|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline diary average pain as covariate, and study site as a random effect.||-0.34|-1.30|0.0008
72477987|NCT02679573|144481693|OTHER|||||||0.5951||||||The log-rank test was used to compare the time to all-cause mortality between the 2 treatment groups.|Log Rank|||||||0.5951
72477988|NCT00682890|144481695|SUPERIORITY_OR_OTHER|||||||0.63|||||||ANOVA|||P value on change at 3 months for placebo group||||0.63
72508919|NCT02650284|144548226|EQUIVALENCE|Equivalence defined as less than or equal to 1 standard deviation between the two means.||||||0.57||||||The number of recruited patients did not reach the required sample size. Power score assessments no longer hold, thus there is low confidence in the findings.|t-test, 2 sided|||To compare VAS Pain at Mobilisation preoperatively between both groups.||||0.57
72508920|NCT02650284|144548226|EQUIVALENCE|Equivalence defined as less than or equal to 1 standard deviation between the two means.||||||0.98||||||The number of recruited patients did not reach the required sample size. Power score assessments no longer hold, thus there is low confidence in the findings.|t-test, 2 sided|||To compare VAS Pain at Mobilisation at 3-months between both groups.||||0.98
72508921|NCT02650284|144548226|EQUIVALENCE|Equivalence defined as less than or equal to 1 standard deviation between the two means.||||||0.58||||||The number of recruited patients did not reach the required sample size. Power score assessments no longer hold, thus there is low confidence in the findings.|t-test, 2 sided|||To compare VAS Pain at Mobilisation at 12-months between both groups.||||0.58
72508922|NCT02650284|144548226|EQUIVALENCE|Equivalence defined as less than or equal to 1 standard deviation between the two means.||||||0.16||||||The number of recruited patients did not reach the required sample size. Power score assessments no longer hold, thus there is low confidence in the findings.|t-test, 2 sided|||To compare VAS Pain at Mobilisation at 24-months between both groups.||||0.16
72477989|NCT00682890|144481695|SUPERIORITY_OR_OTHER|||||||0.42|||||||ANOVA|||||||0.42
72477990|NCT00682890|144481696|SUPERIORITY_OR_OTHER|||||||0.51|||||||ANOVA|||||||0.51
72508923|NCT02650284|144548227|EQUIVALENCE|Equivalence defined as less than or equal to 1 standard deviation between the two means.||||||0.62||||||The number of recruited patients did not reach the required sample size. Power score assessments no longer hold, thus there is low confidence in the findings.|t-test, 2 sided|||To compare New Knee Society Function Score preoperatively between both groups.||||0.62
72508924|NCT02650284|144548227|EQUIVALENCE|Equivalence defined as less than or equal to 1 standard deviation between the two means.||||||0.06||||||The number of recruited patients did not reach the required sample size. Power score assessments no longer hold, thus there is low confidence in the findings.|t-test, 2 sided|||To compare New Knee Society Function Score at 3-months between both groups.||||0.06
72508925|NCT02650284|144548227|EQUIVALENCE|Equivalence defined as less than or equal to 1 standard deviation between the two means.||||||0.93||||||The number of recruited patients did not reach the required sample size. Power score assessments no longer hold, thus there is low confidence in the findings.|t-test, 2 sided|||To compare New Knee Society Function Score at 24-months between both groups.||||0.93
72566434|NCT02697773|144663272|SUPERIORITY||Least Square Mean Difference|-1.04|STANDARD_ERROR_OF_MEAN|0.22|<|0.0001|TWO_SIDED|95.0|-1.47|-0.61|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC stiffness subscales and baseline diary average pain as covariates, and study site as a random effect.||-0.61|-1.47|<.0001
72477991|NCT00682890|144481696|SUPERIORITY_OR_OTHER|||||||0.03|||||||ANOVA|||||||0.03
72477992|NCT03028220|144481697|OTHER|||||||0.01|||||||Wilcoxon (Mann-Whitney)|||||||0.01
72477993|NCT03028220|144481698|OTHER||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||||||<0.01
72477994|NCT03028220|144481699|OTHER||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||||||<0.01
72477995|NCT03028220|144481700|OTHER|||||||1|||||||Wilcoxon (Mann-Whitney)|||||||1.00
72477996|NCT03028220|144481701|OTHER|||||||1|||||||Wilcoxon (Mann-Whitney)|||||||1
72477997|NCT03028220|144481702|OTHER|||||||0.82|||||||Wilcoxon (Mann-Whitney)|||||||0.820
72477998|NCT03028220|144481703|OTHER|||||||0.82|||||||Wilcoxon (Mann-Whitney)|||||||0.820
72477999|NCT03028220|144481704|OTHER|||||||0.57|||||||Wilcoxon (Mann-Whitney)|||||||0.570
72478000|NCT03028220|144481705|OTHER||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||||||<0.01
72478001|NCT03028220|144481706|OTHER|||||||0.91|||||||Wilcoxon (Mann-Whitney)|||||||0.910
72478002|NCT03028220|144481707|OTHER|||||||0.46|||||||Wilcoxon (Mann-Whitney)|||||||0.460
72478003|NCT03028220|144481708|OTHER|||||||0.191|||||||Wilcoxon (Mann-Whitney)|||||||0.191
72478004|NCT00324116|144481713|SUPERIORITY_OR_OTHER||percent responders|85.0||||||95.0|76.0|95.0|||||Proportion of responders estimated by Kaplan-Meier analysis. Proportion of responders along with 95% CI calculated directly from estimate of survival distribution function. Percentage denominator = total number of subjects without missing data.|||95|76|
72478005|NCT00324116|144481714|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.29||||||95.0|-6.83|-1.75|||||95% CI for the change in mean value obtained from one sample t-test.|6 weeks||-1.75|-6.83|
72478006|NCT00324116|144481714|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.86||||||95.0|-9.06|-2.67|||||95% CI for the change in mean value obtained from one sample t-test.|12 weeks||-2.67|-9.06|
72478007|NCT00324116|144481714|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-11.12||||||95.0|-16.28|-5.96|||||95% CI for the change in mean value obtained from one sample t-test.|54 weeks||-5.96|-16.28|
72478008|NCT00324116|144481715|SUPERIORITY_OR_OTHER||percentage of subjects|5.0||||||95.0|1.61|11.32|||||Proportion of subjects gaining vision was estimated on an observed case basis. Percentage denominator = total number of subjects in the FAS. 95% confidence intervals were calculated from Fleiss quadratic equations|||11.32|1.61|
72478009|NCT00324116|144481716|SUPERIORITY_OR_OTHER||percentage of subjects|22.5||||||95.0|14.22|32.11|||||Proportion of subjects maintaining vision was estimated on an observed case basis. Percentage denominator = total number of subjects in the FAS. 95% confidence intervals were calculated from Fleiss quadratic equations.|||32.11|14.22|
72508926|NCT02650284|144548228|EQUIVALENCE|Equivalence defined as less than or equal to 1 standard deviation between the two means.||||||0.57||||||The number of recruited patients did not reach the required sample size. Power score assessments no longer hold, thus there is low confidence in the findings.|t-test, 2 sided|||Comparison between groups at pre-operation timepoint.||||0.57
72478010|NCT00324116|144481717|SUPERIORITY_OR_OTHER||percentage of subjects|13.75||||||95.0|7.39|22.24|||||Proportion of subjects with severe visual loss was estimated on an observed case basis. Percentage denominator = total number of subjects in the FAS. 95% confidence intervals were calculated from Fleiss quadratic equations.|||22.24|7.39|
72478011|NCT00324116|144481718|SUPERIORITY_OR_OTHER||percentage of subjects|25.97||||||95.0|16.28|34.81|||||Proportion of subjects progressing to \<=20/200 was estimated on an observed case basis. Percentage denominator = total number of subjects in the FAS. 95% confidence intervals were calculated from Fleiss quadratic equations.|||34.81|16.28|
72478012|NCT01451827|144481749|SUPERIORITY_OR_OTHER||Ratio of geometric means|0.98||||0.0127|TWO_SIDED|95.0|0.96|1.0|||ANCOVA|||Hierarchical tests were used to control the type I error in the primary analysis. They are given in the following order: 1. Pooled tolvaptan treatment groups (IR and MR) versus placebo; 2. Tolvaptan MR 80 mg versus placebo; 3. Tolvaptan MR 50 mg versus placebo; 4. Tolvaptan IR 60/30 mg versus placebo.||1.00|0.96|0.0127
72478013|NCT01451827|144481749|SUPERIORITY_OR_OTHER||Ratio of geometric means|0.97||||0.0108|TWO_SIDED|95.0|0.95|0.99|||ANCOVA|||Hierarchical tests were used to control the type I error in the primary analysis. They are given in the following order: 1. Pooled tolvaptan treatment groups (IR and MR) versus placebo; 2. Tolvaptan MR 80 mg versus placebo; 3. Tolvaptan MR 50 mg versus placebo; 4. Tolvaptan IR 60/30 mg versus placebo.||0.99|0.95|0.0108
72478014|NCT01451827|144481749|SUPERIORITY_OR_OTHER||Ratio of geometric means|0.98||||0.0155|TWO_SIDED|95.0|0.96|1.0|||ANCOVA|||Hierarchical tests were used to control the type I error in the primary analysis. They are given in the following order: 1. Pooled tolvaptan treatment groups (IR and MR) versus placebo; 2. Tolvaptan MR 80 mg versus placebo; 3. Tolvaptan MR 50 mg versus placebo; 4. Tolvaptan IR 60/30 mg versus placebo.||1.00|0.96|0.0155
72478015|NCT01451827|144481749|SUPERIORITY_OR_OTHER||Ratio of geometric means|0.99||||0.2417|TWO_SIDED|95.0|0.97|1.01|||ANCOVA|||Hierarchical tests were used to control the type I error in the primary analysis. They are given in the following order: 1. Pooled tolvaptan treatment groups (IR and MR) versus placebo; 2. Tolvaptan MR 80 mg versus placebo; 3. Tolvaptan MR 50 mg versus placebo; 4. Tolvaptan IR 60/30 mg versus placebo.||1.01|0.97|0.2417
72478016|NCT01451827|144481750|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.65||||0.0002|TWO_SIDED|95.0|0.31|0.99|||ANCOVA|||Urinary Frequency||0.99|0.31|0.0002
72478017|NCT01451827|144481750|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.74|||<|0.0001|TWO_SIDED|95.0|0.4|1.08|||ANCOVA|||Urinary Frequency||1.08|0.40|< 0.0001
72478018|NCT01451827|144481750|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.92|||<|0.0001|TWO_SIDED|95.0|0.58|1.25|||ANCOVA|||Urinary Frequency||1.25|0.58|< 0.0001
72478019|NCT01451827|144481750|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.66||||0.0004|TWO_SIDED|95.0|0.3|1.01|||ANCOVA|||Urinary Urgency||1.01|0.30|0.0004
72478020|NCT01451827|144481750|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.65||||0.0004|TWO_SIDED|95.0|0.29|1.01|||ANCOVA|||Urinary Urgency||1.01|0.29|0.0004
72478021|NCT01451827|144481750|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.99|||<|0.0001|TWO_SIDED|95.0|0.63|1.34|||ANCOVA|||Urinary Urgency||1.34|0.63|< 0.0001
72478022|NCT01451827|144481750|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.86||||0.0002|TWO_SIDED|95.0|0.42|1.3|||ANCOVA|||Nocturia||1.30|0.42|0.0002
72478023|NCT01451827|144481750|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|1.07|||<|0.0001|TWO_SIDED|95.0|0.63|1.51|||ANCOVA|||Nocturia||1.51|0.63|< 0.0001
72478024|NCT01451827|144481750|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.23|||<|0.0001|TWO_SIDED|95.0|0.8|1.66|||ANCOVA|||Nocturia||1.66|0.80|< 0.0001
72478025|NCT01451827|144481751|SUPERIORITY_OR_OTHER||Ratio of geometric means|0.97||||0.0209|TWO_SIDED|95.0|0.94|0.99|||ANCOVA|||Hierarchical tests were used to control the type I error in the primary analysis. They are given in the following order: 1. Pooled tolvaptan treatment groups (IR and MR) versus placebo; 2. Tolvaptan MR 80 mg versus placebo; 3. Tolvaptan MR 50 mg versus placebo; 4. Tolvaptan IR 60/30 mg versus placebo.||0.99|0.94|0.0209
72478026|NCT01451827|144481751|SUPERIORITY_OR_OTHER||Ratio of geometric means|0.96||||0.0287|TWO_SIDED|95.0|0.93|1.0|||ANCOVA|||Hierarchical tests were used to control the type I error in the primary analysis. They are given in the following order: 1. Pooled tolvaptan treatment groups (IR and MR) versus placebo; 2. Tolvaptan MR 80 mg versus placebo; 3. Tolvaptan MR 50 mg versus placebo; 4. Tolvaptan IR 60/30 mg versus placebo||1.00|0.93|0.0287
72478027|NCT01451827|144481751|SUPERIORITY_OR_OTHER||Ratio of geometric means|0.96||||0.0298|TWO_SIDED|95.0|0.93|1.0|||ANCOVA|||Hierarchical tests were used to control the type I error in the primary analysis. They are given in the following order: 1. Pooled tolvaptan treatment groups (IR and MR) versus placebo; 2. Tolvaptan MR 80 mg versus placebo; 3. Tolvaptan MR 50 mg versus placebo; 4. Tolvaptan IR 60/30 mg versus placebo||1.00|0.93|0.0298
72478028|NCT01451827|144481751|SUPERIORITY_OR_OTHER||Ratio of geometric means|0.98||||0.2306|TWO_SIDED|95.0|0.94|1.01|||ANCOVA|||Hierarchical tests were used to control the type I error in the primary analysis. They are given in the following order: 1. Pooled tolvaptan treatment groups (IR and MR) versus placebo; 2. Tolvaptan MR 80 mg versus placebo; 3. Tolvaptan MR 50 mg versus placebo; 4. Tolvaptan IR 60/30 mg versus placebo||1.01|0.94|0.2306
72478029|NCT01942590|144481834|OTHER|||||||0.0512|||||||t-test, 1 sided|||||||0.0512
72478030|NCT01942590|144481834|OTHER|||||||0.434|||||||t-test, 1 sided|||||||0.434
72478031|NCT01942590|144481835|OTHER|||||||0.0816||||||Paired t test comparing each subject's performance at Week 52 to Baseline|t-test, 1 sided|||||||0.0816
72478032|NCT01942590|144481835|OTHER|||||||0.3318||||||Paired t test comparing each subject's performance at Week 52 to Baseline|t-test, 1 sided|||||||0.3318
72478033|NCT01942590|144481836|OTHER|||||||0.2074|||||||t-test, 1 sided|||||||0.2074
72478034|NCT01942590|144481836|OTHER|||||||0.332|||||||t-test, 1 sided|||||||0.332
72478035|NCT01942590|144481837|OTHER|||||||0.233||||||Paired t test comparing each subject's performance at Week 52 to Baseline|t-test, 1 sided|||||||0.233
72478036|NCT01942590|144481837|OTHER|||||||0.142||||||Paired t test comparing each subject's performance at Week 52 to Baseline|t-test, 1 sided|||||||0.142
72478037|NCT01942590|144481838|OTHER|||||||0.019|||||||t-test, 1 sided|||||||0.019
72508927|NCT02650284|144548228|EQUIVALENCE|Equivalence defined as less than or equal to 1 standard deviation between the two means.||||||0.17||||||The number of recruited patients did not reach the required sample size. Power score assessments no longer hold, thus there is low confidence in the findings.|t-test, 2 sided|||To compare FJS at 3-months between both groups.||||0.17
72508928|NCT02650284|144548228|EQUIVALENCE|Equivalence defined as less than or equal to 1 standard deviation between the two means.||||||0.8||||||The number of recruited patients did not reach the required sample size. Power score assessments no longer hold, thus there is low confidence in the findings.|t-test, 2 sided|||To compare FJS at 12-months between both groups.||||0.80
72508929|NCT02650284|144548228|EQUIVALENCE|Equivalence defined as less than or equal to 1 standard deviation between the two means.||||||0.9||||||The number of recruited patients did not reach the required sample size. Power score assessments no longer hold, thus there is low confidence in the findings.|t-test, 2 sided|||To compare FJS at 24-months between both groups.||||0.90
72508930|NCT02650284|144548230|EQUIVALENCE|Equivalence defined as less than or equal to 1 standard deviation between the two means.||||||0.81||||||The number of recruited patients did not reach the required sample size. Power score assessments no longer hold, thus there is low confidence in the findings.|t-test, 2 sided|||To compare length of hospital stay (number of nights) between both groups.||||0.81
72478038|NCT01942590|144481838|OTHER|||||||0.366|||||||t-test, 1 sided|||||||0.366
72478039|NCT01942590|144481839|OTHER|||||||0.161|||||||t-test, 1 sided|||||||0.161
72478040|NCT01942590|144481839|OTHER|||||||0.43|||||||t-test, 1 sided|||||||0.43
72478041|NCT01942590|144481840|OTHER|||||||0.01|||||||t-test, 1 sided|||Baseline, week 18||||0.01
72478042|NCT01942590|144481840|OTHER|||||||0.004|||||||t-test, 1 sided|||Baseline, week 52||||0.004
72478043|NCT01942590|144481840|OTHER|||||||0.154|||||||t-test, 1 sided|||Baseline, week 18||||0.154
72478044|NCT01942590|144481840|OTHER|||||||0.211|||||||t-test, 1 sided|||Baseline, Week 52||||0.211
72478045|NCT01942590|144481841|OTHER|||||||0.006|||||||t-test, 1 sided|||Baseline, Week 18||||0.006
72478046|NCT01942590|144481841|OTHER|||||||0.007|||||||t-test, 1 sided|||Baseline, Week 52||||0.007
72478047|NCT01942590|144481841|OTHER|||||||0.297|||||||t-test, 1 sided|||Baseline, Week 18||||0.297
72478048|NCT01942590|144481841|OTHER|||||||0.196|||||||t-test, 1 sided|||Baseline, Week 52||||0.196
72478049|NCT01942590|144481842|OTHER|||||||0.3639|||||||t-test, 1 sided|||Baseline Week 18||||0.3639
72478050|NCT01942590|144481842|OTHER|||||||0.0371|||||||t-test, 1 sided|||Baseline, Week 52||||0.0371
72478051|NCT01942590|144481843|OTHER|||||||0.268|||||||t-test, 1 sided|||Baseline, Week 18||||0.268
72478052|NCT01942590|144481843|OTHER|||||||0.0036|||||||t-test, 1 sided|||Baseline, Week 52||||0.0036
72478053|NCT01942590|144481843|OTHER|||||||0.286|||||||t-test, 1 sided|||Baseline, Week 18||||0.286
72478054|NCT01942590|144481843|OTHER|||||||0.279|||||||t-test, 1 sided|||Baseline, Week 52||||0.279
72478055|NCT01942590|144481844|OTHER|||||||0.479|||||||t-test, 1 sided|||Baseline, Week 18||||0.479
72478056|NCT01942590|144481844|OTHER|||||||0.059|||||||t-test, 1 sided|||Baseline, Week 52||||0.059
72478057|NCT01942590|144481844|OTHER|||||||0.152|||||||t-test, 1 sided|||Baseline, Week 18||||0.152
72478058|NCT01942590|144481844|OTHER|||||||0.118|||||||t-test, 1 sided|||Baseline, Week 52||||0.118
72478059|NCT00857272|144481852|NON_INFERIORITY_OR_EQUIVALENCE|Fifteen percent has been established as an acceptable non-inferiority margin for evaluation of investigational bowel preparations in previous studies of FDA approved preparations (e.g. NuLytely, MoviPrep).|Difference in success rates|-2.5||||0.005|TWO_SIDED|95.0|-11.9|6.8|||Chi-squared|||"The primary endpoint of preparation success was tested using a non-inferiority test based upon the difference D=P1-P2,~Null Hypothesis H0: P1-P2\<=D0 versus Alternative Hypothesis H1: P1-P2=D1\>D0,~Where P1 is the % of patients with successful preps in the HalfLytely 5mg group and P2 is the % of patients with successful preps in the HalfLytely 10mg group and D0 is the acceptable margin of equivalence equal to an absolute margin of 15%."||6.8|-11.9|0.005
72508931|NCT00554294|144548231|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.69|||<|0.05||95.0|0.48|0.98|||Regression, Logistic|The Odds Ratio (OR) describes the probability ob beeing overweight of the intervention group compared to the control group (reference, denominator).||adjusted for overweight at baseline, age at baseline,sex and clustering by school||0.98|0.48|<0.05
72399855|NCT00518323|144307308|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.9|STANDARD_ERROR_OF_MEAN|4.15||0.237||95.0|-13.11|3.26||Comparison with placebo was without multiplicity adjustment.|ANCOVA|Used ANCOVA model with treatment(placebo, pali ER Low, pali ER Medium, and pali ER High) and country as factors and baseline value as a covariate.||||3.26|-13.11|0.237
72399856|NCT00518323|144307308|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.7|STANDARD_ERROR_OF_MEAN|4.28||0.119||95.0|-15.15|1.74||Comparison with placebo was without multiplicity adjustment.|ANCOVA|Used ANCOVA model with treatment(placebo, pali ER Low, pali ER Medium, and pali ER High) and country as factors and baseline value as a covariate.||||1.74|-15.15|0.119
72399857|NCT00518323|144307308|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.4|STANDARD_ERROR_OF_MEAN|4.34||0.574||95.0|-11.0|6.11||Comparison with placebo was without multiplicity adjustment.|ANCOVA|Used ANCOVA model with treatment(placebo, pali ER Low, pali ER Medium, and pali ER High) and country as factors and baseline value as a covariate.||||6.11|-11.00|0.574
72399858|NCT01514760|144307312|SUPERIORITY_OR_OTHER|||||||0.03|TWO_SIDED||||||ANCOVA|||This a comparison for participants with uncontrolled asthma at baseline and change in scores over time.||||0.03
72399859|NCT02876900|144307338|SUPERIORITY|Assuming an effect size of 0.35 on the change in PANSS total score from baseline to Week 6 for the 2 pairwise comparisons between each active asenapine maleate transdermal patch treatment arm and placebo, the power for detecting a statistically significant HP-3070 advantage was approximately 0.90, having 204 evaluable participants per each treatment arm using a 2-sided alpha level of 0.025 for each comparison.|Least Square Mean Difference|-4.8|STANDARD_ERROR_OF_MEAN|1.634||0.003|TWO_SIDED|95.0|-8.06|-1.64||Adjusted p-value was calculated according to the truncated Hochberg procedure with a truncation factor y=0.9. Adjustment for multiple comparisons uses a parallel gatekeeping procedure.|Mixed Model Repeated Measures Analysis|||The mixed model for repeated measures includes treatment, country, visit, treatment by visit interaction, and baseline value as covariates, and participant as random effect. The correlation of repeated measures within a participant is estimated with an unstructured covariance matrix. The Kenward-Rogers method is used to estimate the denominator degrees of freedom.||-1.64|-8.06|0.003
72399860|NCT02876900|144307338|SUPERIORITY|Assuming an effect size of 0.35 on the change in PANSS total score from baseline to Week 6 for the 2 pairwise comparisons between each active asenapine maleate transdermal patch treatment arm and placebo, the power for detecting a statistically significant HP-3070 advantage was approximately 0.90, having 204 evaluable participants per each treatment arm using a 2-sided alpha level of 0.025 for each comparison.|Least Square Mean Difference|-6.6|STANDARD_ERROR_OF_MEAN|1.63|<|0.001|TWO_SIDED|95.0|-9.81|-3.4||Adjusted p-value was calculated according to the truncated Hochberg procedure with a truncation factor y=0.9. Adjustment for multiple comparisons uses a parallel gatekeeping procedure.|Mixed Model Repeated Measures Analysis|||The mixed model for repeated measures includes treatment, country, visit, treatment by visit interaction, and baseline value as covariates, and participant as random effect. The correlation of repeated measures within a participant is estimated with an unstructured covariance matrix. The Kenward-Rogers method is used to estimate the denominator degrees of freedom.||-3.4|-9.81|<0.001
72399861|NCT02876900|144307339|SUPERIORITY||Least Square Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.55|-0.16||Adjusted p-value was calculated according to the Hochberg procedure. Adjustment for multiple comparisons uses a parallel gatekeeping procedure.|Mixed Model Repeated Measures Analysis|||The mixed model for repeated measures includes treatment, country, visit, treatment by visit interaction, and baseline value as covariates, and participant as random effect. The correlation of repeated measures within a participant is estimated with an unstructured covariance matrix. The Kenward-Rogers method is used to estimate the denominator degrees of freedom.||-0.16|-0.55|<0.001
72399862|NCT02876900|144307339|SUPERIORITY||Least Square Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.099|<|0.001|TWO_SIDED|95.0|-0.64|-0.25||Adjusted p-value was calculated according to the Hochberg procedure. Adjustment for multiple comparisons uses a parallel gatekeeping procedure.|Mixed Model Repeated Measures Analysis|||The mixed model for repeated measures includes treatment, country, visit, treatment by visit interaction, and baseline value as covariates, and participant as random effect. The correlation of repeated measures within a participant is estimated with an unstructured covariance matrix. The Kenward-Rogers method is used to estimate the denominator degrees of freedom.||-0.25|-0.64|<0.001
72399863|NCT01592344|144307340|SUPERIORITY_OR_OTHER|||||||0.0048|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.0048
72399864|NCT01592344|144307341|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||t-test, 2 sided|||||||<0.0001
72399865|NCT01592344|144307342|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||t-test, 2 sided|||||||<0.0001
72399866|NCT01592344|144307343|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||t-test, 2 sided|||||||<0.0001
72399867|NCT04327388|144307402|SUPERIORITY||Hazard Ratio (HR)|1.026||||0.9561|TWO_SIDED|95.0|0.751|1.402|||Log-rank test|Analyzed based on logrank test stratified by severity of illness (severe, critical) and use of systemic corticosteroids (Yes, No) as entered in IRT.|Hazard ratio for estimation of treatment effect of each sarilumab dose versus placebo was assessed by cox proportional hazard model stratified by severity of illness (severe, critical) and use of systemic corticosteroids (Yes, No) as entered in IRT.|||1.402|0.751|0.9561
72399868|NCT04327388|144307402|SUPERIORITY||Hazard Ratio (HR)|1.135||||0.3376|TWO_SIDED|95.0|0.835|1.543|||Log-rank test|Analyzed based on logrank test stratified by severity of illness (severe, critical) and use of systemic corticosteroids (Yes, No) as entered in IRT.|Hazard ratio for estimation of treatment effect of each sarilumab dose versus placebo was assessed by cox proportional hazard model stratified by severity of illness (severe, critical) and use of systemic corticosteroids (Yes, No) as entered in IRT.|||1.543|0.835|0.3376
72399869|NCT04327388|144307403|SUPERIORITY||Difference in percentage|-1.7||||0.628|TWO_SIDED|95.0|-9.27|5.81|||Cochran-Mantel-Haenszel|By Cochran-Mantel-Haenszel test stratified by severity of illness (severe, critical) and use of systemic corticosteroids (Yes, No) as entered in IRT.||||5.81|-9.27|0.6280
72508932|NCT00337467|144548313|SUPERIORITY_OR_OTHER||Percentage of Participants|21.3|||||TWO_SIDED|95.0|11.9|33.7|||exact binomial methods|Given the small sample size, the 95% confidence interval is made with exact binomial methods.||||33.7|11.9|
72508933|NCT00337467|144548314|SUPERIORITY_OR_OTHER||Percentage of Participants|34.4|||||TWO_SIDED|95.0|22.7|47.7|||exact binomial methods|Given the small sample size, the 95% confidence interval is made with exact binomial methods.||||47.7|22.7|
72508934|NCT00337467|144548319|SUPERIORITY_OR_OTHER||Mean Change (Final Values)|61.0|STANDARD_ERROR_OF_MEAN|24.3|||TWO_SIDED|95.0|12.3|109.8|||normal approximation for 95% CI|||||109.8|12.3|
72623382|NCT00323622|144777536|SUPERIORITY_OR_OTHER||1 - (R1/R2)|7.08||||0.54|TWO_SIDED|95.0|-17.37|26.44||The p-value presented is the Wald Chi-square p-value from the Cox regression model.|Regression, Cox|||The analysis aimed to compare rates of first PFMI (RPFMI) between groups over the Months 33-45 time period. Using RFPMI, a Cox model was used to evaluate vaccine efficacy (VE) allowing for adjustment factors. VE, point estimate of efficacy adjusted for covariates, was calculated as 1 - (minus) \[Hazard Ratio (HR) in Cohort 1 - RTS,S/AS02A Group \[HR1\]) divided by HR in Cohort 1 - Engerix-B/Prevnar-Hiberix Group \[HR2\])\], i. e. 1 - (HR1/HR2).||26.44|-17.37|0.54
72623383|NCT00323622|144777537|SUPERIORITY_OR_OTHER||1 - (R1/R2)|16.79||||0.1|TWO_SIDED|95.0|-3.75|33.25||The p-value presented is the Wald Chi-square p-value from the Cox regression model.|Regression, Cox|||The analysis aimed to compare rates of first PFMI (RPFMI) between groups over the Months 21-33 time period. Using RFPMI, a Cox model was used to evaluate vaccine efficacy (VE) allowing for adjustment factors. VE, point estimate of efficacy adjusted for covariates, was calculated as 1 - (minus) \[Hazard Ratio (HR) in Cohort 1 - RTS,S/AS02A Group \[HR1\]) divided by HR in Cohort 1 - Engerix-B/Prevnar-Hiberix Group \[HR2\])\], i. e. 1 - (HR1/HR2).||33.25|-3.75|0.10
72623384|NCT00323622|144777537|SUPERIORITY_OR_OTHER||1 - (R1/R2)|6.31||||0.7|TWO_SIDED|95.0|-31.0|32.99||The p-value presented is the Wald Chi-square p-value from the Cox regression model.|Regression, Cox|Point estimate of efficacy was adjusted for age, geographical area of residence, bednet use and distance from health center.||The analysis aimed to compare rates of first PFMI (RPFMI) between groups over the Months 33-45 time period. Using RFPMI, a Cox model was used to evaluate vaccine efficacy (VE) allowing for adjustment factors. VE, point estimate of efficacy adjusted for covariates, was calculated as 1 - (minus) \[Hazard Ratio (HR) in Cohort 1 - RTS,S/AS02A Group \[HR1\]) divided by HR in Cohort 1 - Engerix-B/Prevnar-Hiberix Group \[HR2\])\], i. e. 1 - (HR1/HR2).||32.99|-31.00|0.70
72399870|NCT04327388|144307403|SUPERIORITY||Difference in percentage|0.2||||0.8478|TWO_SIDED|95.0|-6.93|7.41|||Cochran-Mantel-Haenszel|By Cochran-Mantel-Haenszel test stratified by severity of illness (severe, critical) and use of systemic corticosteroids (Yes, No) as entered in IRT.||||7.41|-6.93|0.8478
72399871|NCT00391274|144307445|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.5||||0.1326||95.0|0.76|8.25||Logistic regression of best overall tumor response (complete response + partial response).|Regression, Logistic|Treatment was the only covariate.||||8.25|0.76|0.1326
72399872|NCT00391274|144307446|SUPERIORITY_OR_OTHER|||||||0.7704||95.0|||||Log Rank|||||||0.7704
72399873|NCT00391274|144307446|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.05||||0.7784||95.0|0.75|1.46|||Regression, Cox|Treatment was the only covariate.||||1.46|0.75|0.7784
72399874|NCT00391274|144307449|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.14||||0.4921||95.0|0.78|1.68||P-value for Overall Survival (up to 24 months)|Regression, Cox|Treatment was the only covariate.||||1.68|0.78|0.4921
72399875|NCT00391274|144307449|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.02||||0.9256|TWO_SIDED|95.0|0.74|1.4||P-value for Overall Survival (up to 30 months)|Regression, Cox|||||1.40|0.74|0.9256
72399876|NCT01387347|144307451|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.18||||0.2596|||||||t-test, 2 sided|||Inferior corneal fluorescein staining score at Day 29(primary sign) was summarized using descriptive statistics (number of observations, mean, standard deviation, median, minimum, and maximum). Active treatment was compared to placebo using a two-sample t-test assuming unequal variances, assessed at the α = 0.05 level||||0.2596
72399877|NCT01387347|144307451|SUPERIORITY_OR_OTHER|||||||0.0075|TWO_SIDED||||||t-test, 2 sided|||Comparison of central corneal fluorescein staining score between the placebo and Thymosin beta 4 groups||||0.0075
72399878|NCT01387347|144307451|SUPERIORITY_OR_OTHER|||||||0.021|TWO_SIDED||||||t-test, 2 sided|||Comparison of superior corneal fluorescein staining score between the placebo and Thymosin beta 4 groups||||0.0210
72399879|NCT01387347|144307452|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3||||0.3734|TWO_SIDED||||||t-test, 2 sided|||Comparison between the groups uses a two-sample t-test assuming unequal variances, assessed at the alpha = 0.05 level.||||0.3734
72399880|NCT01387347|144307452|SUPERIORITY_OR_OTHER|||||||0.0244|TWO_SIDED||||||t-test, 2 sided|||Comparison of discomfort score between the placebo and Thymosin beta 4 groups on Day 28||||0.0244
72399881|NCT01519960|144307454|OTHER||Odds Ratio (OR)|5.43|||=|0.0043|TWO_SIDED|95.0|1.54|19.2|||Cochran-Mantel-Haenszel|||Analysis stratified by hepatitis B virus (HBV) genotype A versus non-A genotypes and alanine aminotransferase (ALT) less than (\<) 5 times (×) upper limit of normal (ULN) versus greater than or equal to (≥) 5 × ULN at Baseline. The OR was calculated using Group B as reference.||19.2|1.54|= 0.0043
72399882|NCT01519960|144307454|OTHER||||||=|0.3732|||||||Breslow-Day|||||||= 0.3732
72399883|NCT00561080|144307530|NON_INFERIORITY_OR_EQUIVALENCE|Superiority was achieved if the lower bound of the 2-sided 95% CI of the GMT ratio was greater than 1.2|Geometric Mean Titer Ratio (GMTR)|1.11||||0.948|TWO_SIDED|95.0|1.02|1.22|||ANOVA||GMTR = GMT Post Dose 2/GMT Post dose 1|||1.22|1.02|0.948
72399884|NCT00561080|144307530|NON_INFERIORITY_OR_EQUIVALENCE|Superiority was achieved if the lower bound of the 2-sided 95% CI of the GMT ratio was greater than 1.2|GMTR|0.78|||>|0.999|TWO_SIDED|95.0|0.73|0.85|||ANOVA||GMTR = GMT Post Dose 2/GMT Post dose 1|||0.85|0.73|>0.999
72399885|NCT00561080|144307531|SUPERIORITY_OR_OTHER||GMFR|2.35|||||TWO_SIDED|95.0|2.11|2.62|||||GMFR=GMT Post Dose/GMT Pre Dose|||2.62|2.11|
72399886|NCT00561080|144307533|SUPERIORITY_OR_OTHER||GMT Ratio|1.06|||||TWO_SIDED|95.0|0.96|1.17|||||GMT Ratio = Group 2 GMT/Group 1 GMT|ANCOVA model includes country and age at first vaccination as independent variables and baseline antibody titre as covariate. The GMT 12-month post-last dose is the GMT adjusted from the ANCOVA model||1.17|0.96|
72399887|NCT00561080|144307533|SUPERIORITY_OR_OTHER||GMT Ratio|1.08|||||TWO_SIDED|95.0|0.98|1.19|||||GMT Ratio = GMT Group 3/GMT Group 1|ANCOVA model includes country and age at first vaccination as independent variables and baseline antibody titre as covariate. The GMT 12-month post-last dose is the GMT adjusted from the ANCOVA model||1.19|0.98|
72399888|NCT05778786|144307577|SUPERIORITY|A superiority margin of 0.0 logMAR was used.|Least-Square Mean|-0.13|STANDARD_ERROR_OF_MEAN|0.012|||ONE_SIDED|95.0||-0.1|||Linear Mixed Model|||It was calculated using a 1-sided one sample mean t-test with a type I error rate of 0.025 that 9 subjects provide at least 99% statistical power to test for superiority.||-0.10||
72399889|NCT05778786|144307578|SUPERIORITY|A superiority margin of 62 points was used.|Least-quares mean|69.4|STANDARD_ERROR_OF_MEAN|2.13|||ONE_SIDED|95.0|65.2||||Linear Mixed Model|||It was calculated using a 1-sided one sample mean t-test with a type I error rate of 0.025 that 165 subjects provide at least 99% statistical power to test for superiority.|||65.2|
72399890|NCT05778786|144307579|SUPERIORITY|A superiority margin of 0.80 was used|Mean Central Posterior Proportion|0.974|STANDARD_DEVIATION|0.01|||TWO_SIDED|95.0|0.95|0.989|||Bayesian beta- binomial model|Method used is Bayesian beta- binomial model for correlated binary data||It was calculated using a Bayesian beta-binomial model for correlated data with a reference rate of 0.99 and an intraclass correlation of 0.70, that 100 subjects were required to test for superiority to achieve a minimum statistical power of 99% with 95% central posterior credible interval.||0.989|0.950|
72478060|NCT01285609|144481863|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.907||||0.2517|TWO_SIDED|95.0|0.767|1.072|||Log Rank|p-value based on an unstratified 2-sided log rank test|Hazard of Ipilimumab over Hazard of Placebo with 2-sided 95% confidence intervals are based on an unstratified Cox proportional hazards model with treatment as the single covariate|Hazard ratio = Ipilimumab with Paclitaxel/Carboplatin over Placebo with Paclitaxel/Carboplatin||1.072|0.767|0.2517
72478061|NCT01285609|144481864|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.917||||0.2421|TWO_SIDED|95.0|0.792|1.061||p-value based on stratified 2-sided log-rank test|Log Rank||Hazard of Ipilimumab over Placebo with 2-sided 95% confidence intervals based on a stratified Cox proportional hazards model with several stratification factors and treatment as the single covariate|Hazard ratio = Ipilimumab with Paclitaxel/Carboplatin over Placebo with Paclitaxel/Carboplatin||1.061|0.792|0.2421
72478062|NCT01285609|144481865|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.869||||0.0678|TWO_SIDED|95.0|0.749|1.009|||Log Rank|p-value based on an unstratified 2-sided log rank test|Hazard of Ipilimumab over Hazard of Placebo with 2-sided 95% confidence intervals are based on an unstratified Cox proportional hazards model with treatment as the single covariate|Hazard ratio = Ipilimumab with Paclitaxel/Carboplatin over Placebo with Paclitaxel/Carboplatin||1.009|0.749|0.0678
72478063|NCT03283072|144481866|SUPERIORITY|||||||0.592|||||||ANCOVA|Within, within repeated measures ANCOVA (gender as co-variate).||||||0.592
72478064|NCT03283072|144481867|SUPERIORITY|||||||0.721|||||||ANCOVA|Within, within repeated measures ANCOVA (gender as co-variate).||||||0.721
72478065|NCT03283072|144481868|SUPERIORITY|||||||0.553|||||||ANCOVA|Within, within repeated measures ANVOA (gender as covariate)||||||0.553
72478066|NCT02552368|144481885|SUPERIORITY|||||||0.002|||||||Paired t-Test|||||||0.002
72478067|NCT02552368|144481886|SUPERIORITY|||||||0.022|||||||Wilcoxon (Mann-Whitney)|||Signed-Rank Test for Performance COPM between Baseline and 12 weeks||||0.022
72478068|NCT02552368|144481886|SUPERIORITY|||||||0.031|||||||Wilcoxon (Mann-Whitney)|||Signed-Rank Test for Satisfaction COPM between Baseline and 12 weeks||||0.031
72478069|NCT03616977|144481888|EQUIVALENCE|Bioequivalence will be concluded if the 2-sided 90% Confidence Interval is completely contained within the interval (0.80, 1.25).|Ratio of geometric least squares means|1.01|||||TWO_SIDED|90.0|0.961|1.06||||||||1.06|0.961|
72478070|NCT01323972|144481899|OTHER||GMT ratio|1.32|||||TWO_SIDED|95.0|1.06|1.65|||||Consistency was demonstrated if one month post Dose 3, the 2-sided 95% confidence interval (CI) of the geometric mean titer (GMT) ratio between all pairs of lots were within \[0.5, 2\].|Demonstration of the lot-to-lot consistency between GSK 257049-Lot 1 and GSK 257049-Lot 2 in terms of anti-Circumsporozoite (anti-CS) immunogenicity.||1.65|1.06|
72478071|NCT01323972|144481899|OTHER||GMT ratio|1.06|||||TWO_SIDED|95.0|0.85|1.32|||||Consistency was demonstrated if one month post Dose 3, the 2-sided 95% confidence interval (CI) of the geometric mean titer (GMT) ratio between all pairs of lots were within \[0.5, 2\].|Demonstration of the lot-to-lot consistency between GSK 257049-Lot 1 and GSK 257049-Lot 3 in terms of anti-Circumsporozoite (anti-CS) immunogenicity.||1.32|0.85|
72478072|NCT01323972|144481899|OTHER||GMT ratio|0.8||||||95.0|0.64|1.0|||||Consistency was demonstrated if one month post Dose 3, the 2-sided 95% confidence interval (CI) of the geometric mean titer (GMT) ratio between all pairs of lots were within \[0.5, 2\].|Demonstration of the lot-to-lot consistency between GSK 257049-Lot 2 and GSK 257049-Lot 3 in terms of anti-Circumsporozoite (anti-CS) immunogenicity.||1|0.64|
72478073|NCT01323972|144481899|NON_INFERIORITY|Non-inferiority was demonstrated if one month post Dose 3, the upper limit (UL) of the 2-sided 95% CI of the GMT ratio of the pilot scale lot (Control Group) over the pooled commercial scale lots (Pooled Log Group) was below 2.|GMT ratio|0.95||||||95.0|0.79|1.15||||||Demonstration of non-inferiority of the commercial scale lots of GSK 257049 to the pilot scale lot in terms of anti-Circumsporozoite (anti-CS) immunogenicity.||1.15|0.79|
72478074|NCT02909764|144481933|OTHER|||||||0.3|||||||ANOVA|||||||0.30
72478075|NCT02909764|144481934|OTHER|Yates's chi-square analyses were used to determine which of the two cereals children in each group preferred at baseline and after the 8-week exposure period, and whether the number of children who shifted preference from the regular cereal at baseline to the low salt cereal after the exposure period differed between groups.|||||<|0.05|||||||Chi-squared|||Yates's chi-square analyses were used to determine which of the two cereals children in each group preferred at baseline and after the 8-week exposure period, and whether the number of children who shifted preference from the regular cereal at baseline to the low salt cereal after the exposure period differed between groups.||||<0.05
72478076|NCT02909764|144481935|OTHER|||||||0.32|||||||ANOVA|||||||0.32
72508935|NCT00337467|144548320|SUPERIORITY_OR_OTHER||Mean Change (Final Values)|53.0|STANDARD_ERROR_OF_MEAN|30.0|||TWO_SIDED|95.0|-7.1|113.7|||normal approximation for 95% CI|||||113.7|-7.1|
72508936|NCT00337467|144548321|SUPERIORITY_OR_OTHER||Mean Change (Final Values)|63.0|STANDARD_ERROR_OF_MEAN|32.9|||TWO_SIDED|95.0|-4.0|129.1|||normal approximation for 95% CI|||||129.1|-4.0|
72478077|NCT02909764|144481936|OTHER|||||||0.77|||||||ANOVA|||||||0.77
72478078|NCT02909764|144481937|OTHER|General estimating equations (GEE)|||||<|0.05|||||||GEE|||Generalized estimating equations (GEE) were conducted on the amount of cereal in grams ingested during 28 days home-exposure period. The GEE approach accounts for the repeated measurements of outcomes over time for each child and examines whether the slopes of the lines created differ between the treatment groups.||||<0.05
72478079|NCT02909764|144481938|OTHER|T-tests were conducted to determine whether differences in baseline blood pressure between groups|||||>|0.4|||||||t-test, 2 sided|||T-tests were conducted to determine whether differences in baseline blood pressure between the two groups.||||>0.40
72508937|NCT00337467|144548323|SUPERIORITY_OR_OTHER||Mean Change|9.0|STANDARD_ERROR_OF_MEAN|3.0|||TWO_SIDED|95.0|2.5|14.6|||normal approximation for 95% CI|||Percent Change from Baseline in Fasting Total Cholesterol at Week 48||14.6|2.5|
72508938|NCT00337467|144548323|SUPERIORITY_OR_OTHER||Mean Change|2.0|STANDARD_ERROR_OF_MEAN|3.1|||TWO_SIDED|95.0|-3.9|8.8|||normal approximation for 95% CI|||Percent Change from Baseline in Fasting HDL Cholesterol at Week 48||8.8|-3.9|
72399891|NCT05778786|144307580|SUPERIORITY|A superiority margin of 0.80 was used|Mean Central Posterior Proportion|0.989|STANDARD_DEVIATION|0.0054|||TWO_SIDED|95.0|0.976|0.997|||Bayesian beta-binomial model|Method used is Bayesian beta- binomial model for correlated binary data||It was calculated using a Bayesian beta-binomial model for correlated data with a reference rate of 0.99 and an intraclass correlation of 0.70, that 100 subjects were required to test for superiority to achieve a minimum statistical power of 99% with 95% central posterior credible interval.||0.997|0.976|
72478080|NCT03527173|144481993|NON_INFERIORITY|VE in reduction of shigellosis is demonstrated if lower limit (LL) of 90% CI of VE estimated with Miettinen-Nurminen (M-N) method is above 0. This estimated CI was complemented with Barnard test. The LL of the 90% CI for VE calculated with M-N method is above 0 if the p-value of the one-sided Barnard test is below 5%.|Vaccine efficacy rate|-9.4||||0.4266|TWO_SIDED|90.0|-96.7|33.7|||1-sided Barnard Unconditional Exact Test|||To demonstrate the efficacy of two vaccinations with 25 µg of S. sonnei vaccine in healthy adults compared to placebo in preventing shigellosis, fulfilling the protocol primary case definition, after challenge with S. sonnei 53G strain. Vaccine efficacy (VE) rate was assessed as 1-Risk Ratio(RR) with RR = ratio of proportion of subjects with shigellosis in the vaccinated group on the proportion of subjects with shigellosis in the placebo group.||33.7|-96.7|0.4266
72478081|NCT01248780|144482019|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
72478082|NCT01248780|144482020|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
72478083|NCT01248780|144482021|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
72478084|NCT01248780|144482022|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA|||||||<0.001
72478085|NCT01190514|144482063|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence of the two treatments was to be concluded if the 90% CIs for the ratio of adjusted geometric means for AUC48 fell wholly within (80%, 125%).|ratio (%) of adjusted geometric means|95.56|||||TWO_SIDED|90.0|86.94|105.04|||Mixed Models Analysis||Adjusted mean difference and the 90% CI for the difference were exponentiated to provide an estimate of the ratio of adjusted geometric means (test/reference).|"DVS SR 25 mg\*2 fasted (test); DVS SR 50 mg fasted (reference).~Natural log transformed AUC48: mixed models analysis with sequence, period, treatment (formulation by food status) as fixed effects and subject within sequence as a random effect."||105.04|86.94|
72478086|NCT01190514|144482063|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence of the two treatments was to be concluded if the 90% CIs for the ratio of adjusted geometric means for AUC48 fell wholly within (80%, 125%).|ratio (%) of adjusted geometric means|101.31|||||TWO_SIDED|90.0|97.17|105.64|||Mixed Models Analysis||Adjusted mean difference and the 90% CI for the difference were exponentiated to provide an estimate of the ratio of adjusted geometric means (test/reference).|"DVS SR 25 mg\*2 fed (test); DVS SR 50 mg fed (reference).~Natural log transformed AUC48: mixed models analysis with sequence, period, treatment (formulation by food status) as fixed effects and subject within sequence as a random effect."||105.64|97.17|
72478087|NCT01190514|144482063|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence of the two treatments was to be concluded if the 90% CIs for the ratio of adjusted geometric means for AUC48 fell wholly within (80%, 125%).|ratio (%) of adjusted geometric means|108.76|||||TWO_SIDED|90.0|101.1|117.01|||Mixed Models Analysis||Adjusted mean difference and the 90% CI for the difference were exponentiated to provide an estimate of the ratio of adjusted geometric means (test/reference).|"Food effect DVS SR 50 mg fed (test) versus DVS SR 50 mg fasted (reference).~Natural log transformed AUC48: mixed models analysis with sequence, period, treatment (formulation by food status) as fixed effects and subject within sequence as a random effect."||117.01|101.10|
72478088|NCT01190514|144482065|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence of the two treatments was to be concluded if the 90% CIs for the ratio of adjusted geometric means for Cmax fell wholly within (80%, 125%).|Ratio (%) of adjusted geometric means|95.1|||||TWO_SIDED|90.0|89.37|101.2|||Mixed Models Analysis||Adjusted mean difference and the 90% CI for the difference were exponentiated to provide an estimate of the ratio of adjusted geometric means (test/reference).|"DVS SR 25 mg\*2 fasted (test); DVS SR 50 mg fasted (reference).~Natural log transformed Cmax: mixed models analysis with sequence, period, treatment (formulation by food status) as fixed effects and subject within sequence as a random effect."||101.20|89.37|
72478089|NCT01190514|144482065|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence of the two treatments was to be concluded if the 90% CIs for the ratio of adjusted geometric means for Cmax fell wholly within (80%, 125%).|Ratio (%) of adjusted geometric means|101.3|||||TWO_SIDED|90.0|94.66|108.4|||Mixed Models Analysis||Adjusted mean difference and the 90% CI for the difference were exponentiated to provide an estimate of the ratio of adjusted geometric means (test/reference).|"DVS SR 25 mg\*2 fed (test); DVS SR 50 mg fed (reference).~Natural log transformed Cmax: mixed models analysis with sequence, period, treatment (formulation by food status) as fixed effects and subject within sequence as a random effect."||108.40|94.66|
72478090|NCT01190514|144482065|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence of the two treatments was to be concluded if the 90% CIs for the ratio of adjusted geometric means for Cmax fell wholly within (80%, 125%).|ratio (%) of adjusted geometric means|115.54|||||TWO_SIDED|90.0|108.59|122.94|||Mixed Models Analysis||Adjusted mean difference and the 90% CI for the difference were exponentiated to provide an estimate of the ratio of adjusted geometric means (test/reference).|"Food effect DVS SR 50 mg fed (test) versus DVS SR 50 mg fasted (reference).~Natural log transformed Cmax: mixed models analysis with sequence, period, treatment (formulation by food status) as fixed effects and subject within sequence as a random effect."||122.94|108.59|
72478091|NCT00107120|144482072|SUPERIORITY_OR_OTHER||Least Square Means Difference|-3.4|STANDARD_ERROR_OF_MEAN|1.458||0.022||95.0|-6.2|-0.5||Two-sided at 5% level of significance p \< 0.05 considered significant|ANCOVA|The model included study center and treatment as factors and baseline core as covariate|Differences are Escitalopram-Placebo|The null hypothesis is that there is no difference in the Change from Baseline to Week 8 in CDRS-R total score between treatment groups. The power calculation was based on the change from baseline to Week 8 in CDRS-R total score (LOCF approach). Assuming an effect size (treatment group difference relative to standard deviation) of 0.325, a sample size of approximately 150 patients per treatment group was used to provide at least 80% power at a significance level of 0.05 using a two-sided test.||-0.5|-6.2|0.022
72399892|NCT05778786|144307581|SUPERIORITY|A superiority margin of 0.80 was used|Mean Central Posterior Proportion|0.989|STANDARD_DEVIATION|0.0053|||TWO_SIDED|95.0|0.977|0.997|||Bayesian beta- binomial model|Method used is Bayesian beta- binomial model for correlated binary data||It was calculated using a Bayesian beta-binomial model for correlated data with a reference rate of 0.99 and an intraclass correlation of 0.70, that 100 subjects were required to test for superiority to achieve a minimum statistical power of 99% with 95% central posterior credible interval.||0.997|0.977|
72399893|NCT05778786|144307582|SUPERIORITY|A superiority margin of 0.05 was used.|Mean Central Posterior Proportion|0.003|STANDARD_DEVIATION|0.0028|||TWO_SIDED|95.0|0.0|0.01|||Bayesian beta-binomial model|Bayesian beta- binomial model for correlated binary data||It was calculated using a Bayesian beta-binomial model for correlated data with a reference rate of 0.01 and an intraclass correlation of 0.70, that 100 subjects were required to test for superiority to achieve a minimum statistical power of 99% with 95% central posterior credible Interval.||0.010|0.000|
72399894|NCT05778786|144307583|SUPERIORITY|A superiority margin of 58 points was used.|Least-squares Mean|66.1|STANDARD_ERROR_OF_MEAN|2.48|||ONE_SIDED|95.0|61.2||||Linear Mixed Model|||It was calculated using a 1-sided one sample mean t-test with a type I error rate of 0.025 that 135 subjects provide at least 97% statistical power to test for superiority.|||61.2|
72399895|NCT05778786|144307584|SUPERIORITY|A superiority margin of 61 points was used.|Least-squares Mean|69.9|STANDARD_ERROR_OF_MEAN|1.66|||ONE_SIDED|95.0|66.6||||Linear Mixed Model|||It was calculated using a 1-sided one sample mean t-test with a type I error rate of 0.025 that 135 subjects provide at least 97% statistical power to test for superiority.|||66.6|
72399896|NCT01602380|144307585|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.797||||0.0486|TWO_SIDED|95.0|0.637|0.999||2-sided p-value|Log Rank|Stratified log-rank test with factors for prior chemotherapy for locally advanced or metastatic disease and measurable disease at baseline.|A hazard ratio \< 1 favours fulvestrant.|If the true PFS HR for comparison of fulvestrant vs. anastrozole was 0.69 (likely to correspond to a 45% prolongation of PFS) the study had 90% power to demonstrate a statistically significant difference for PFS with a one-sided type 1 error of 2.5% (two-sided 5%).||0.999|0.637|0.0486
72478092|NCT00107120|144482073|SUPERIORITY_OR_OTHER||Least Square Means Difference|-0.344|STANDARD_ERROR_OF_MEAN|0.1128||0.008||95.0|-0.595|0.092||Two-sided at 5% level of significance|ANCOVA|The model included treatment and center as factors and baseline CGI-Severity score as covariate.|Differences are Escitalopram-Placebo|Missing values were imputed using the LOCF approach.||0.092|-0.595|0.008
72478093|NCT00107120|144482074|SUPERIORITY_OR_OTHER||Least Square Means Difference|2.169|STANDARD_ERROR_OF_MEAN|1.324||0.103||95.0|-0.439|4.777||Two-sided at 5% level of significance|ANCOVA||Differences are Escitalopram-Placebo|ANCOVA on the Change from Baseline to Week 8 in CGAS score. The model included treatment and center as factors and baseline score as covariate. Missing values were imputed using the LOCF approach.||4.777|-0.439|0.103
72478094|NCT01171807|144482119|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
72478095|NCT04101318|144482134|SUPERIORITY||Mean Difference (Final Values)|0.12||||0.625|TWO_SIDED|95.0|-0.38|0.62||The threshold for statistical significance was p=0.05. Furthermore, p-value was not adjusted for multiple comparisons|Mixed Models Analysis|Model was with the following fixed effects: product and period. Subject and the interaction between product and subject were random effects|Difference between Arm 1 and Arm 2= Mean (Arm 1) - Mean (Arm 2)|Null hypothesis: There is no difference between the two arms.||0.62|-0.38|0.625
72478096|NCT04101318|144482135|SUPERIORITY||Odds Ratio (OR)|1.737||||0.036|TWO_SIDED|95.0|1.038|2.908||The threshold for statistical significance was p=0.05. Furthermore, p-value was not adjusted for multiple comparisons|Proportional odds ratio model|Ordinal regression model for itching evaluated on a 5 point scale. Product and period are fixed effects and subject is a random effect.|Odds ratio, marginal= Arm1/Arm2|Null hypothesis: There is no difference between the two arms.||2.908|1.038|0.036
72478097|NCT04101318|144482136|SUPERIORITY||Mean Difference (Final Values)|-0.35||||0.202|TWO_SIDED|95.0|-0.9|0.2||The threshold for statistical significance was p=0.05. Furthermore, p-value was not adjusted for multiple comparisons|Mixed Models Analysis|The mode had following fixed effects: product and period. Subject and the interaction between product and subject were random effects.|Difference between Arm 1 and Arm 2= Mean (Arm 1) - Mean (Arm 2)|Null hypothesis: There is no difference between the two arms.||0.20|-0.90|0.202
72478098|NCT04101318|144482137|SUPERIORITY||Odds Ratio (OR)|1.369||||0.267|TWO_SIDED|95.0|0.781|2.401||The threshold for statistical significance was p=0.05. Furthermore, p-value was not adjusted for multiple comparisons|Proportional odds ratio model|Ordinal regression model for pain evaluated on a 5 point scale. Product and period are fixed effects and subject is a random effect.|Odds ratio, marginal= Arm1/Arm2|Null hypothesis: There is no difference between the two arms.||2.401|0.781|0.267
72478099|NCT04101318|144482138|SUPERIORITY||Mean Difference (Final Values)|-0.13||||0.545|TWO_SIDED|95.0|-0.57|0.3||The threshold for statistical significance was p=0.05. Furthermore, p-value was not adjusted for multiple comparisons|Mixed Models Analysis|Model was with the following fixed effects: product and period. Subject and the interaction between product and subject were random effects|Difference between Arm 1 and Arm 2= Mean (Arm 1) - Mean (Arm 2)|Null hypothesis: There is no difference between the two arms.||0.30|-0.57|0.545
72478100|NCT04101318|144482139|SUPERIORITY||Odds Ratio (OR)|1.316||||0.293|TWO_SIDED|95.0|0.783|2.211||The threshold for statistical significance was p=0.05. Furthermore, p-value was not adjusted for multiple comparisons|Proportional odds ratio model|Ordinal regression model for burning evaluated on a 5 point scale. Product and period are fixed effects and subject is a random effect.|Odds ratio, marginal= Arm1/Arm2|Null hypothesis: There is no difference between the two arms.||2.211|0.783|0.293
72478101|NCT04101318|144482140|SUPERIORITY||Odds Ratio (OR)|0.82||||0.375|TWO_SIDED|95.0|0.53|1.27||The threshold for statistical significance was p=0.05. Furthermore, p-value was not adjusted for multiple comparisons|Mixed Models Analysis|generalized linear mixed repeated model with fixed effects|Odds ratio, marginal= Arm1/Arm2|There is no difference between the two arms.||1.27|0.53|0.375
72478102|NCT04101318|144482141|SUPERIORITY||Odds Ratio (OR)|0.83||||0.482|TWO_SIDED|95.0|0.49|1.4||The threshold for statistical significance was p=0.05. Furthermore, p-value was not adjusted for multiple comparisons|Mixed Models Analysis|generalized linear mixed repeated model with fixed effects|Odds ratio, marginal= Arm1/Arm2|Null hypothesis: There is no difference between the two arms.||1.40|0.49|0.482
72508939|NCT00337467|144548323|SUPERIORITY_OR_OTHER||Mean Change|12.0|STANDARD_ERROR_OF_MEAN|4.1|||TWO_SIDED|95.0|4.0|20.8|||normal approximation for 95% CI|||Percent Change from Baseline in Fasting Non-HDL Cholesterol at Week 48||20.8|4.0|
72478103|NCT04101318|144482142|SUPERIORITY||Odds Ratio (OR)|0.7||||0.151|TWO_SIDED|95.0|0.43|1.14||The threshold for statistical significance was p=0.05. Furthermore, p-value was not adjusted for multiple comparisons|Mixed Models Analysis|generalized linear mixed repeated model with fixed effects||Null hypothesis: There is no difference between the two arms.|Odds ratio, marginal= Arm1/Arm2|1.14|0.43|0.151
72566435|NCT02697773|144663272|SUPERIORITY||Least Mean Square Difference|-1.05|STANDARD_ERROR_OF_MEAN|0.22|<|0.0001|TWO_SIDED|95.0|-1.47|-0.62|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC stiffness subscales and baseline diary average pain as covariates, and study site as a random effect.||-0.62|-1.47|<.0001
72478104|NCT04101318|144482143|SUPERIORITY||Mean Difference (Final Values)|0.08||||0.725|TWO_SIDED|95.0|-0.39|0.56||The threshold for statistical significance was p=0.05. Furthermore, p-value was not adjusted for multiple comparisons|Mixed Models Analysis|Model was with the following fixed effects: product and period. Subject and the interaction between product and subject were random effects.|Difference between Arm 1 and Arm 2= Mean (Arm 1) - Mean (Arm 2)|Null hypothesis: There is no difference between the two arms.||0.56|-0.39|0.725
72478105|NCT04101318|144482144|SUPERIORITY||Mean Difference (Final Values)|0.09||||0.721|TWO_SIDED|95.0|-0.39|0.56||The threshold for statistical significance was p=0.05. Furthermore, p-value was not adjusted for multiple comparisons|Mixed Models Analysis|Model was with the following fixed effects: product and period. Subject and the interaction between product and subject were random effects.|Difference between Arm 1 and Arm 2= Mean (Arm 1) - Mean (Arm 2)|Null hypothesis: There is no difference between the two arms.||0.56|-0.39|0.721
72478106|NCT04101318|144482145|SUPERIORITY||Mean Difference (Final Values)|-0.05||||0.753|TWO_SIDED|95.0|-0.38|0.28||The threshold for statistical significance was p=0.05. Furthermore, p-value was not adjusted for multiple comparisons|Mixed Models Analysis|Model was with the following fixed effects: product and period. Subject and the interaction between product and subject were random effects.|Difference between Arm 1 and Arm 2= Mean (Arm 1) - Mean (Arm 2)|Null hypothesis: There is no difference between the two arms.||0.28|-0.38|0.753
72478107|NCT04101318|144482146|SUPERIORITY||Mean Difference (Final Values)|1.37||||0.331|TWO_SIDED|95.0|-1.43|4.18||The threshold for statistical significance was p=0.05. Furthermore, p-value was not adjusted for multiple comparisons|Mixed Models Analysis|Model was with the following fixed effects: product and period. Subject and the interaction between product and subject were random effects.|Difference between Arm 1 and Arm 2= Mean (Arm 1) - Mean (Arm 2)|Null hypothesis: There is no difference between the two arms.||4.18|-1.43|0.331
72478108|NCT04101318|144482147|SUPERIORITY||Mean Difference (Final Values)|11.68||||0.239|TWO_SIDED|95.0|-7.98|31.34||The threshold for statistical significance was p=0.05. Furthermore, p-value was not adjusted for multiple comparisons|Mixed Models Analysis|Model was with the following fixed effects: product and period. Subject and the interaction between product and subject were random effects.|Difference between Arm 1 and Arm 2= Mean (Arm 1) - Mean (Arm 2)|Null hypothesis: There is no difference between the two arms.||31.34|-7.98|0.239
72478109|NCT04101318|144482148|SUPERIORITY||Mean Difference (Final Values)|-0.3||||0.322|TWO_SIDED|95.0|-0.91|0.31||The threshold for statistical significance was p=0.05. Furthermore, p-value was not adjusted for multiple comparisons|Mixed Models Analysis|Model was with the following fixed effects: product and period. Subject was a random effect.|Difference between Arm 1 and Arm 2= Mean (Arm 1) - Mean (Arm 2)|Null hypothesis: There is no difference between the two arms.||0.31|-0.91|0.322
72478110|NCT04101318|144482149|SUPERIORITY||Mean Difference (Final Values)|-0.14||||0.343|TWO_SIDED|95.0|-0.44|0.15||The threshold for statistical significance was p=0.05. Furthermore, p-value was not adjusted for multiple comparisons|Mixed Models Analysis|Model was with the following fixed effects: product and period. Subject was a random effect.|Difference between Arm 1 and Arm 2= Mean (Arm 1) - Mean (Arm 2)|Null hypothesis: There is no difference between the two arms.||0.15|-0.44|0.343
72478111|NCT04101318|144482150|SUPERIORITY||Mean Difference (Final Values)|-0.16||||0.387|TWO_SIDED|95.0|-0.53|0.21||The threshold for statistical significance was p=0.05. Furthermore, p-value was not adjusted for multiple comparisons|Mixed Models Analysis|Model was with the following fixed effects: product and period. Subject was a random effect.|Difference between Arm 1 and Arm 2= Mean (Arm 1) - Mean (Arm 2)|Null hypothesis: There is no difference between the two arms.||0.21|-0.53|0.387
72478112|NCT04101318|144482151|SUPERIORITY||Mean Difference (Final Values)|-0.01||||0.899|TWO_SIDED|95.0|-0.18|0.16||The threshold for statistical significance was p=0.05. Furthermore, p-value was not adjusted for multiple comparisons|Mixed Models Analysis|Model was with the following fixed effects: product and period. Subject was a random effect.|Difference between Arm 1 and Arm 2= Mean (Arm 1) - Mean (Arm 2)|Null hypothesis: There is no difference between the two arms.||0.16|-0.18|0.899
72478113|NCT01981473|144482160|SUPERIORITY_OR_OTHER||||||<|0.0001||||||As there was only one primary endpoint, no adjustment was made for multiple comparisons.|Fisher Exact|Logistic regression was to be used but the model was not fit as there were no antibodies in the etanercept group. Fisher's exact test was used.||This sample was to provide \>95% power to detect a difference of 12% in the proportion of participants positive for antidrug antibodies between the group of participants treated with a soluble receptor TNF inhibitor (etanercept) and the group of participants treated with mAB TNF inhibitors (adalimumab and infliximab) (5% vs 17%, respectively), using a Chi square test with continuity correction, an alpha of 0.05, and attrition rate of 15%.||||<0.0001
72478114|NCT02257567|144482206|SUPERIORITY||Difference in Response Rates|5.82||||0.5353|TWO_SIDED|95.0|-14.53|25.38|||Cochran-Mantel-Haenszel|||||25.38|-14.53|0.5353
72478115|NCT02257567|144482206|SUPERIORITY||Difference in Response Rates (4.89|25.0||||0.0128|TWO_SIDED|95.0|4.89|42.63|||Cochran-Mantel-Haenszel|||||42.63|4.89|0.0128
72478116|NCT02257567|144482215|SUPERIORITY||Difference in Response Rates|0.69||||0.8817|TWO_SIDED|95.0|-19.68|20.86|||Cochran-Mantel-Haenszel|||||20.86|-19.68|0.8817
72478117|NCT02257567|144482215|SUPERIORITY||Difference in Response Rates|27.5||||0.0061|TWO_SIDED|95.0|7.66|44.74|||Cochran-Mantel-Haenszel|||||44.74|7.66|0.0061
72478118|NCT02257567|144482217|SUPERIORITY||Difference in Response Rates|-1.0||||0.9523|TWO_SIDED|95.0|-18.66|16.46|||Cochran-Mantel-Haenszel|||||16.46|-18.66|0.9523
72623385|NCT04191135|144777571|SUPERIORITY||Hazard Ratio (HR)|0.98||||0.4556|TWO_SIDED|95.0|0.72|1.33||One-sided p-value based on log-rank test stratified by response to the induction therapy (CR/PR versus SD), tumor PD-L1 status (CPS ≥1 vs CPS \<1) and BRCA Status (BRCAm versus wild type BRCA gene).|Log Rank||Estimate via stratified Cox model with Efron's handling method with treatment as a covariate stratified by response to the induction therapy (CR/PR versus SD), tumor PD-L1 status (CPS ≥1 vs CPS \<1) and BRCA Status (BRCAm versus wild type BRCA gene).|||1.33|0.72|0.4556
72478119|NCT02257567|144482217|SUPERIORITY||Difference in Response Rates|30.0||||0.0036|TWO_SIDED|95.0|9.48|47.37|||Cochran-Mantel-Haenszel|||||47.37|9.48|0.0036
72478120|NCT02257567|144482218|SUPERIORITY||Difference in Response Rates|3.75||||0.6574|TWO_SIDED|95.0|-15.14|22.11|||Cochran-Mantel-Haenszel|||||22.11|-15.14|0.6574
72478121|NCT02257567|144482218|SUPERIORITY||Difference in Response Rates|25.0||||0.0128|TWO_SIDED|95.0|4.89|42.63|||Cochran-Mantel-Haenszel|||||42.63|4.89|0.0128
72508940|NCT00337467|144548323|SUPERIORITY_OR_OTHER||Mean Change|20.0|STANDARD_ERROR_OF_MEAN|5.8|||TWO_SIDED|95.0|8.0|31.7|||normal approximation for 95% CI|||Percent Change from Baseline in Fasting LDL Cholesterol at Week 48||31.7|8.0|
72508941|NCT00337467|144548323|SUPERIORITY_OR_OTHER||Mean Change|17.0|STANDARD_ERROR_OF_MEAN|8.6|||TWO_SIDED|95.0|-0.4|34.4|||normal approximation for 95% CI|||Percent Change from Baseline in Fasting Triglycerides at Week 48||34.4|-0.4|
72508942|NCT00337467|144548324|SUPERIORITY_OR_OTHER||Mean Change|14.0|STANDARD_ERROR_OF_MEAN|3.2||||95.0|6.9|20.1|||normal approximation for 95% CI|||Percent Change from Baseline in Fasting Total Cholesterol at Week 96||20.1|6.9|
72508943|NCT00337467|144548324|SUPERIORITY_OR_OTHER||Mean Change|2.0|STANDARD_ERROR_OF_MEAN|3.9|||TWO_SIDED|95.0|-6.0|10.2|||normal approximation for 95% CI|||Percent Change from Baseline in Fasting HDL Cholesterol at Week 96||10.2|-6.0|
72508944|NCT00337467|144548324|SUPERIORITY_OR_OTHER||Mean Change|19.0|STANDARD_ERROR_OF_MEAN|4.4|||TWO_SIDED|95.0|10.3|28.4|||normal approximation for 95% CI|||Percent Change from Baseline in Fasting Non-HDL Cholesterol at Week 96||28.4|10.3|
72508945|NCT00337467|144548324|SUPERIORITY_OR_OTHER||Mean Change|29.0|STANDARD_ERROR_OF_MEAN|6.5|||TWO_SIDED|95.0|15.3|42.0|||normal approximation for 95% CI|||Percent Change from Baseline in Fasting LDL Cholesterol at Week 96||42.0|15.3|
72508946|NCT00337467|144548324|SUPERIORITY_OR_OTHER||Mean Change|16.0|STANDARD_ERROR_OF_MEAN|12.5|||TWO_SIDED|95.0|-9.5|41.6|||normal approximation for 95% CI|||Percent Change from Baseline in Fasting Triglycerides at Week 96||41.6|-9.5|
72508947|NCT04083222|144548327|SUPERIORITY||||||<|0.001||||||P-value was analyzed using Analysis of Variance (ANOVA) with treatment and screening angiotensin-converting enzyme inhibitor/ angiotensin receptor blockers (ACEi/ARB) dose status stratification factor.|ANOVA|||||||< 0.001
72508948|NCT04083222|144548328|SUPERIORITY|||||||0.399||||||P-value was analyzed using ANOVA with treatment and screening ACE/ARB dose status stratification factor.|ANOVA|||Day 3||||0.399
72508949|NCT04083222|144548328|SUPERIORITY|||||||0.338||||||P-value was analyzed using ANOVA with treatment and screening ACE/ARB dose status stratification factor.|ANOVA|||Day 8||||0.338
72508950|NCT04083222|144548328|SUPERIORITY|||||||0.207||||||P-value was analyzed using ANOVA with treatment and screening ACE/ARB dose status stratification factor.|ANOVA|||Day 15||||0.207
72508951|NCT04083222|144548328|SUPERIORITY|||||||0.927||||||P-value was analyzed using ANOVA with treatment and screening ACE/ARB dose status stratification factor.|ANOVA|||Day 22||||0.927
72508952|NCT04083222|144548328|SUPERIORITY|||||||0.146||||||P-value was analyzed using ANOVA with treatment and screening ACE/ARB dose status stratification factor.|ANOVA|||Day 29||||0.146
72508953|NCT04083222|144548328|SUPERIORITY|||||||0.055||||||P-value was analyzed using ANOVA with treatment and screening ACE/ARB dose status stratification factor.|ANOVA|||Day 36||||0.055
72508954|NCT04083222|144548328|SUPERIORITY|||||||0.095||||||P-value was analyzed using ANOVA with treatment and screening ACE/ARB dose status stratification factor.|ANOVA|||Day 43||||0.095
72508955|NCT04083222|144548328|SUPERIORITY|||||||0.046||||||P-value was analyzed using ANOVA with treatment and screening ACE/ARB dose status stratification factor.|ANOVA|||Day 50||||0.046
72478122|NCT02257567|144482221|SUPERIORITY||Difference in Response Rates|3.88||||0.6225|TWO_SIDED|95.0|-14.49|21.72|||Cochran-Mantel-Haenszel|||||21.72|-14.49|0.6225
72478123|NCT02257567|144482221|SUPERIORITY||Difference in Response Rates|30.0||||0.0032|TWO_SIDED|95.0|9.94|47.12|||Cochran-Mantel-Haenszel|||||47.12|9.94|0.0032
72478124|NCT02257567|144482222|SUPERIORITY||Difference in Response Rates|-6.13||||0.4835|TWO_SIDED|95.0|-24.14|12.12|||Cochran-Mantel-Haenszel|||||12.12|-24.14|0.4835
72478125|NCT02257567|144482222|SUPERIORITY||Difference in Response Rates|25.0||||0.0096|TWO_SIDED|95.0|5.39|42.33|||Cochran-Mantel-Haenszel|||||42.33|5.39|0.0096
72478126|NCT02257567|144482223|SUPERIORITY||Difference in Response Rates|-0.5||||0.939|TWO_SIDED|95.0|-15.07|13.71|||Cochran-Mantel-Haenszel|||||13.71|-15.07|0.9390
72478127|NCT02257567|144482223|SUPERIORITY||Difference in Response Rates|37.5||||0.0006|TWO_SIDED|95.0|15.64|54.71|||Cochran-Mantel-Haenszel|||||54.71|15.64|0.0006
72478128|NCT02257567|144482224|SUPERIORITY||Difference in Response Rates|37.5||||0.0005|TWO_SIDED|95.0|15.82|54.62|||Cochran-Mantel-Haenszel|||||54.62|15.82|0.0005
72508956|NCT04083222|144548328|SUPERIORITY|||||||0.246||||||P-value was analyzed using ANOVA with treatment and screening ACE/ARB dose status stratification factor.|ANOVA|||Day 57||||0.246
72508957|NCT04083222|144548328|SUPERIORITY|||||||0.17||||||P-value was analyzed using ANOVA with treatment and screening ACE/ARB dose status stratification factor.|ANOVA|||Day 64||||0.170
72508958|NCT04083222|144548328|SUPERIORITY|||||||0.527||||||P-value was analyzed using ANOVA with treatment and screening ACE/ARB dose status stratification factor.|ANOVA|||Day 78||||0.527
72508959|NCT04083222|144548328|SUPERIORITY|||||||0.167||||||P-value was analyzed using ANOVA with treatment and screening ACE/ARB dose status stratification factor.|ANOVA|||Day 92||||0.167
72508960|NCT04083222|144548328|SUPERIORITY|||||||0.266||||||P-value was analyzed using ANOVA with treatment and screening ACE/ARB dose status stratification factor.|ANOVA|||Day 120||||0.266
72508961|NCT04083222|144548328|SUPERIORITY|||||||0.078||||||P-value was analyzed using ANOVA with treatment and screening ACE/ARB dose status stratification factor.|ANOVA|||Day 141||||0.078
72508962|NCT04083222|144548329|SUPERIORITY|||||||0.661||||||P-value was analyzed using ANOVA with treatment and screening ACE/ARB dose status stratification factor.|ANOVA|||Day 3||||0.661
72508963|NCT04083222|144548329|SUPERIORITY||||||<|0.001||||||P-value was analyzed using ANOVA with treatment and screening ACE/ARB dose status stratification factor.|ANOVA|||Day 8||||<0.001
72478129|NCT02257567|144482225|SUPERIORITY||Hazard Ratio (HR)|0.42||||0.0245|TWO_SIDED|95.0|0.19|0.91|||Log Rank|||||0.91|0.19|0.0245
72478130|NCT02257567|144482226|SUPERIORITY||Hazard Ratio (HR)|0.6||||0.2451|TWO_SIDED|95.0|0.25|1.43|||Log Rank|||||1.43|0.25|0.2451
72478131|NCT02257567|144482227|SUPERIORITY||Hazard Ratio (HR)|0.33|||<|0.0001|TWO_SIDED|95.0|0.2|0.56|||Log Rank|||||0.56|0.20|<.0001
72478132|NCT02257567|144482228|SUPERIORITY||Hazard Ratio (HR)|0.39||||0.0003|TWO_SIDED|95.0|0.23|0.66|||Log Rank|||||0.66|0.23|0.0003
72478133|NCT01288521|144482325|SUPERIORITY|The null hypothesis is that the tacrolimus biovailability alone is equal to the tacrolimus bioavailability when given with ketoconazole.||||||0.006|||||||Regression, Linear|The bioavailability with Tac alone vs. Tac +keto was compared using linear model adjusting for sex and creatinine clearance.||The bioavailability of Tac alone vs. Tac +keto was compared using a general linear model including sex and creatinine clearance as covariates.||||0.006
72478134|NCT02884908|144482329|SUPERIORITY|Based on randomization to treatment condition, the model assumed no differences at baseline (any difference was assumed due to random sampling error).||||||0.8|||||||Mixed Models Analysis|||||||0.80
72478135|NCT02884908|144482330|SUPERIORITY|Based on randomization to treatment condition, the model assumed no differences at baseline (any difference was assumed due to random sampling error).||||||0.9|||||||Mixed Models Analysis|||||||0.90
72478136|NCT02884908|144482331|SUPERIORITY|Based on randomization to treatment condition, the model assumed no differences at baseline (any difference was assumed due to random sampling error).||||||0.38|||||||Mixed Models Analysis|||||||0.38
72478137|NCT01502631|144482336|SUPERIORITY||Least Squares (LS) Mean|5.61|STANDARD_ERROR_OF_MEAN|4.497||0.2182|TWO_SIDED|90.0|-1.93|13.14|||Mixed Model Repeated Measures (MMRM)|||Difference (SUN13837 - Placebo) at Week 2||13.14|-1.93|0.2182
72478138|NCT01502631|144482336|SUPERIORITY||Least Squares (LS) Mean|6.87|STANDARD_ERROR_OF_MEAN|5.583||0.226|TWO_SIDED|90.0|-2.54|16.27|||Mixed Model Repeated Measures (MMRM)|||Difference (SUN13837 - Placebo) at Week 4||16.27|-2.54|0.2260
72478139|NCT01502631|144482336|SUPERIORITY||Least Squares (LS) Mean|3.03|STANDARD_ERROR_OF_MEAN|6.023||0.6184|TWO_SIDED|90.0|-7.15|13.21|||Mixed Model Repeated Measures (MMRM)|||Difference (SUN13837 - Placebo) at Week 8||13.21|-7.15|0.6184
72508964|NCT04083222|144548329|SUPERIORITY||||||<|0.001||||||P-value was analyzed using ANOVA with treatment and screening ACE/ARB dose status stratification factor.|ANOVA|||Day 15||||<0.001
72399897|NCT01602380|144307586|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.966||||0.7579|TWO_SIDED|95.0|0.773|1.206||2-sided p-value|Log Rank|Stratified log-rank test with factors for prior chemotherapy for locally advanced or metastatic disease and measurable disease at baseline.|A HR of \<1 favours fulvestrant.|65% OS maturity||1.206|0.773|0.7579
72399898|NCT01602380|144307587|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.074||||0.729|TWO_SIDED|95.0|0.716|1.614||2-sided p-value|Regression, Logistic|||||1.614|0.716|0.7290
72478140|NCT01502631|144482336|SUPERIORITY||Least Squares (LS) Mean|4.54|STANDARD_ERROR_OF_MEAN|6.524||0.4912|TWO_SIDED|90.0|-6.48|15.56|||Mixed Model Repeated Measures (MMRM)|||Difference (SUN13837 - Placebo) at Week 16||15.56|-6.48|0.4912
72478141|NCT02084056|144482343|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratios of the geometric means (FDC/free combination) using an acceptance range of 80.00 to 125.00%.|Adjusted Geometric Means ratio|103.68|STANDARD_ERROR_OF_MEAN|1.018|<|0.0001|TWO_SIDED|90.0|100.703|106.747|||ANOVA|ANOVA on the logarithmic scale including effects for 'sequence', 'subjects within sequences', 'period', and 'treatment'|Ratio of (FDC 2000 fasted/ L+M 2000 fasted)|||106.747|100.703|<0.0001
72478142|NCT02084056|144482343|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratios of the geometric means (FDC/free combination) using an acceptance range of 80.00 to 125.00%.|Adjusted Geometric Means ratio|101.63|STANDARD_ERROR_OF_MEAN|1.047||0.0003|TWO_SIDED|90.0|93.721|110.202|||ANOVA|ANOVA on the logarithmic scale including effects for 'sequence', 'subjects within sequences', 'period', and 'treatment'.|Ratio of (FDC 2000 fed/ L+M 2000 fed)|||110.202|93.721|0.0003
72478143|NCT02084056|144482344|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratios of the geometric means (FDC/free combination) using an acceptance range of 80.00 to 125.00%.|Adjusted Geometric Means ratio|114.58|STANDARD_ERROR_OF_MEAN|1.038||0.0113|TWO_SIDED|90.0|107.687|121.908|||ANOVA|ANOVA on the logarithmic scale including effects for 'sequence', 'subjects within sequences', 'period', and 'treatment'|Ratio of (FDC 2000 fasted/ L+M 2000 fasted)|||121.908|107.687|0.0113
72478144|NCT02084056|144482344|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratios of the geometric means (FDC/free combination) using an acceptance range of 80.00 to 125.00%.|Adjusted Geometric Means ratio|98.28|STANDARD_ERROR_OF_MEAN|1.075||0.0064|TWO_SIDED|90.0|86.543|111.609|||ANOVA|ANOVA on the logarithmic scale including effects for 'sequence', 'subjects within sequences', 'period', and 'treatment'.|Ratio of (FDC 2000 fed/ L+M 2000 fed)|||111.609|86.543|0.0064
72478145|NCT02084056|144482345|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratios of the geometric means (FDC/free combination) using an acceptance range of 80.00 to 125.00%.|Adjusted Geometric Means ratio|96.45|STANDARD_ERROR_OF_MEAN|1.03|<|0.0001|TWO_SIDED|90.0|91.23|101.97|||ANOVA|ANOVA on the logarithmic scale including effects for 'sequence', 'subjects within sequences', 'period', and 'treatment'|Ratio of (FDC 2000 fasted/ L+M 2000 fasted)|||101.97|91.23|<0.0001
72399899|NCT01602380|144307589|SUPERIORITY_OR_OTHER_LEGACY||Rato of EDoR|1.52||||0.0367|TWO_SIDED|95.0|1.03|2.26||2-sided p-value|Method of Ellis et al|||||2.26|1.03|0.0367
72508965|NCT04083222|144548329|SUPERIORITY||||||<|0.001||||||P-value was analyzed using ANOVA with treatment and screening ACE/ARB dose status stratification factor.|ANOVA|||Day 22||||<0.001
72508966|NCT04083222|144548329|SUPERIORITY||||||<|0.001||||||P-value was analyzed using ANOVA with treatment and screening ACE/ARB dose status stratification factor.|ANOVA|||Day 29||||<0.001
72508967|NCT04083222|144548329|SUPERIORITY||||||<|0.001||||||P-value was analyzed using ANOVA with treatment and screening ACE/ARB dose status stratification factor.|ANOVA|||Day 36||||<0.001
72508968|NCT04083222|144548329|SUPERIORITY||||||<|0.001||||||P-value was analyzed using ANOVA with treatment and screening ACE/ARB dose status stratification factor.|ANOVA|||Day 43||||<0.001
72566436|NCT02697773|144663272|SUPERIORITY||Least Square Mean Difference|-1.24|STANDARD_ERROR_OF_MEAN|0.22|<|0.0001|TWO_SIDED|95.0|-1.67|-0.81|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC stiffness subscales and baseline diary average pain as covariates, and study site as a random effect.||-0.81|-1.67|<.0001
72399900|NCT01602380|144307590|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.253||||0.3045|TWO_SIDED|95.0|0.815|1.932||2-sided p-value|Regression, Logistic|||||1.932|0.815|0.3045
72478146|NCT02084056|144482345|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratios of the geometric means (FDC/free combination) using an acceptance range of 80.00 to 125.00%.|Adjusted Geometric Means ratio|97.75|STANDARD_ERROR_OF_MEAN|1.04||0.0002|TWO_SIDED|90.0|90.47|105.63|||ANOVA|ANOVA on the logarithmic scale including effects for 'sequence', 'subjects within sequences', 'period', and 'treatment'.|Ratio of (FDC 2000 fed/ L+M 2000 fed)|||105.63|90.47|0.0002
72566437|NCT02697773|144663272|SUPERIORITY||Least Square Mean Difference|-1.23|STANDARD_ERROR_OF_MEAN|0.22|<|0.0001|TWO_SIDED|95.0|-1.66|-0.8|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC stiffness subscales and baseline diary average pain as covariates, and study site as a random effect.||-0.80|-1.66|<.0001
72478147|NCT02084056|144482346|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratios of the geometric means (FDC/free combination) using an acceptance range of 80.00 to 125.00%.|Adjusted Geometric Means ratio|97.96|STANDARD_ERROR_OF_MEAN|1.038|<|0.0001|TWO_SIDED|90.0|92.046|104.257|||ANOVA|ANOVA on the logarithmic scale including effects for 'sequence', 'subjects within sequences', 'period', and 'treatment'|Ratio of (FDC 2000 fasted/ L+M 2000 fasted)|||104.257|92.046|<0.0001
72478148|NCT02084056|144482346|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratios of the geometric means (FDC/free combination) using an acceptance range of 80.00 to 125.00%.|Adjusted Geometric Means ratio|105.85|STANDARD_ERROR_OF_MEAN|1.053||0.003|TWO_SIDED|90.0|96.705|115.861|||ANOVA|ANOVA on the logarithmic scale including effects for 'sequence', 'subjects within sequences', 'period', and 'treatment'.|Ratio of (FDC 2000 fed/ L+M 2000 fed)|||115.861|96.705|0.0030
72478149|NCT02084056|144482347|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratios of the geometric means (FDC/free combination) using an acceptance range of 80.00 to 125.00%.|Adjusted Geometric Means ratio|103.48|STANDARD_ERROR_OF_MEAN|1.03|<|0.0001|TWO_SIDED|90.0|98.426|108.79|||ANOVA|ANOVA on the logarithmic scale including effects for 'sequence', 'subjects within sequences', 'period', and 'treatment'|Ratio of (FDC 2000 fasted/ L+M 2000 fasted)|||108.790|98.426|<0.0001
72478150|NCT02084056|144482347|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratios of the geometric means (FDC/free combination) using an acceptance range of 80.00 to 125.00%.|Adjusted Geometric Means ratio|101.35|STANDARD_ERROR_OF_MEAN|1.062||0.0019|TWO_SIDED|90.0|91.13|112.708|||ANOVA|ANOVA on the logarithmic scale including effects for 'sequence', 'subjects within sequences', 'period', and 'treatment'.|Ratio of (FDC 2000 fed/ L+M 2000 fed)|||112.708|91.130|0.0019
72478151|NCT02084056|144482348|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratios of the geometric means (FDC/free combination) using an acceptance range of 80.00 to 125.00%.|Adjusted Geometric Means ratio|95.49|STANDARD_ERROR_OF_MEAN|1.04|<|0.0001|TWO_SIDED|90.0|89.73|101.62|||ANOVA|ANOVA on the logarithmic scale including effects for 'sequence', 'subjects within sequences', 'period', and 'treatment'|Ratio of (FDC 2000 fasted/ L+M 2000 fasted)|||101.62|89.73|<0.0001
72478152|NCT02084056|144482348|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratios of the geometric means (FDC/free combination) using an acceptance range of 80.00 to 125.00%.|Adjusted Geometric Means ratio|98.19|STANDARD_ERROR_OF_MEAN|1.05||0.0002|TWO_SIDED|90.0|90.73|106.27|||ANOVA|ANOVA on the logarithmic scale including effects for 'sequence', 'subjects within sequences', 'period', and 'treatment'.|Ratio of (FDC 2000 fed/ L+M 2000 fed)|||106.27|90.73|0.0002
72478153|NCT00395460|144482389|NON_INFERIORITY_OR_EQUIVALENCE|The analysis was performed by means of a Confidence Interval (CI) approach: noninferiority of Gadavist was assumed if the one-sided 95% CI for pGadavist-pMagnevist was lying entirely to the right of the value -delta, where p is the estimated change in CNR and with pre-defined non-inferiority margin delta of 15% (=6.52 or 15% of 43.467).|Mean Difference (Final Values)|6.939|STANDARD_DEVIATION|38.83|||ONE_SIDED|95.0|-3.897||||non-inferiority||||||-3.897|
72478154|NCT00190749|144482454|SUPERIORITY_OR_OTHER|||||||0.226||95.0||||P-value for change to last observation|t-test, 2 sided|||||||0.226
72399901|NCT01602380|144307592|SUPERIORITY_OR_OTHER_LEGACY||Ratio of EDoCB|1.26||||0.0561||95.0|0.99|1.59||2-sided p-value|Method of Ellis et al|||||1.59|0.99|0.0561
72478155|NCT00190749|144482454|SUPERIORITY_OR_OTHER|||||||0.03||95.0||||P-value is change to last observation|t-test, 2 sided|||||||0.030
72478156|NCT00190749|144482454|SUPERIORITY_OR_OTHER|||||||0.204||95.0||||P-value for change to last observation.|ANCOVA|||||||0.204
72478157|NCT00190749|144482455|SUPERIORITY_OR_OTHER|||||||0.184||95.0|||||Pearson's correlation coefficient|||||||0.184
72478158|NCT00190749|144482455|SUPERIORITY_OR_OTHER|||||||0.295||95.0|||||Pearson's correlation coefficient|||||||0.295
72478159|NCT00190749|144482456|SUPERIORITY_OR_OTHER|||||||0.256||95.0|||||Pearson's correlation coefficient|||||||0.256
72478160|NCT00190749|144482456|SUPERIORITY_OR_OTHER|||||||0.277||95.0|||||Pearson's correlation coefficient|||||||0.277
72478161|NCT00190749|144482457|SUPERIORITY_OR_OTHER|||||||0.766||95.0|||||Pearson's correlation coefficient|||||||0.766
72478162|NCT00190749|144482457|SUPERIORITY_OR_OTHER|||||||0.622||95.0|||||Pearson's correlation coefficient|||||||0.622
72478163|NCT00190749|144482458|SUPERIORITY_OR_OTHER|||||||0.829||95.0|||||Pearson's correlation coefficient|||||||0.829
72566438|NCT02697773|144663272|SUPERIORITY||Least Square Mean Difference|-0.79|STANDARD_ERROR_OF_MEAN|0.23||0.0007|TWO_SIDED|95.0|-1.25|-0.33|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC stiffness subscales and baseline diary average pain as covariates, and study site as a random effect.||-0.33|-1.25|0.0007
72566439|NCT02697773|144663272|SUPERIORITY||Least Square Mean Difference|-0.74|STANDARD_ERROR_OF_MEAN|0.23||0.0013|TWO_SIDED|95.0|-1.2|-0.29|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC stiffness subscales and baseline diary average pain as covariates, and study site as a random effect.||-0.29|-1.20|0.0013
72566440|NCT02697773|144663272|SUPERIORITY||Least Square Mean Difference|-1.03|STANDARD_ERROR_OF_MEAN|0.24|<|0.0001|TWO_SIDED|95.0|-1.51|-0.55|||ANCOVA|||Week 12: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC stiffness subscales and baseline diary average pain as covariates, and study site as a random effect.||-0.55|-1.51|<.0001
72566441|NCT02697773|144663272|SUPERIORITY||Least Square Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|0.24|<|0.0001|TWO_SIDED|95.0|-1.67|-0.73|||ANCOVA|||Week 12: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC stiffness subscales and baseline diary average pain as covariates, and study site as a random effect.||-0.73|-1.67|<.0001
72566442|NCT02697773|144663272|SUPERIORITY||Least Square Mean Difference|-0.84|STANDARD_ERROR_OF_MEAN|0.25||0.0007|TWO_SIDED|95.0|-1.32|-0.35|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC stiffness subscales and baseline diary average pain as covariates, and study site as a random effect.||-0.35|-1.32|0.0007
72566443|NCT02697773|144663272|SUPERIORITY||Least Square Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.25|<|0.0001|TWO_SIDED|95.0|-1.48|-0.51|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC stiffness subscales and baseline diary average pain as covariates, and study site as a random effect.||-0.51|-1.48|<.0001
72566444|NCT02697773|144663274|SUPERIORITY||Least Square Mean Difference|-0.82|STANDARD_ERROR_OF_MEAN|0.21|<|0.0001|TWO_SIDED|95.0|-1.22|-0.41|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC average score and baseline diary average pain as covariates, and study site as a random effect.||-0.41|-1.22|<.0001
72399902|NCT01602380|144307593|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.88||||0.2846|TWO_SIDED|95.0|0.7|1.11||2-sided p-value|Log Rank|Stratified log-rank test with factors for prior chemotherapy for locally advanced/metastatic disease and measurable/non-measurable disease at baseline|A hazard ratio \< 1 favours fulvestrant.|Comparative statistical analysis for time to deterioration of TOI score is presented (fulvestrant versus anastrozole).||1.11|0.70|0.2846
72399903|NCT01602380|144307593|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.82||||0.0844|TWO_SIDED|95.0|0.66|1.03||2-sided p-value|Log Rank|Stratified log-rank test with factors for prior chemotherapy for locally advanced/metastatic disease and measurable/non-measurable disease at baseline|A hazard ratio \< 1 favours fulvestrant.|Comparative statistical analysis for time to deterioration of FACT-B total score is presented (fulvestrant versus anastrozole).||1.03|0.66|0.0844
72399904|NCT01064401|144307596|SUPERIORITY_OR_OTHER||Rate Ratio|0.55|||<|0.0001|TWO_SIDED|95.0|0.469|0.645||Estimated from a negative binomial regression model adjusted for the baseline relapse rate, history of prior IFN beta use, baseline EDSS (≤ 2.5 vs \> 2.5) and baseline age (≤ 35 vs \> 35 years).|Negative Binomial Regression|||||0.645|0.469|< 0.0001
72566445|NCT02697773|144663274|SUPERIORITY||Least Square Mean Difference|-0.88|STANDARD_ERROR_OF_MEAN|0.21|<|0.0001|TWO_SIDED|95.0|-1.29|-0.48|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC average score and baseline diary average pain as covariates, and study site as a random effect.||-0.48|-1.29|<.0001
72566446|NCT02697773|144663274|SUPERIORITY||Least Square Mean Difference|-1.05|STANDARD_ERROR_OF_MEAN|0.21|<|0.0001|TWO_SIDED|95.0|-1.46|-0.63|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC average score and baseline diary average pain as covariates, and study site as a random effect.||-0.63|-1.46|<.0001
72623386|NCT04191135|144777572|SUPERIORITY||Hazard Ratio (HR)|0.95||||0.3903|TWO_SIDED|95.0|0.64|1.4||One-sided p-value based on log-rank test stratified by response to the induction therapy (CR/PR versus SD), tumor PD-L1 status (CPS ≥1 vs CPS \<1) and BRCA Status (BRCAm versus wild type BRCA gene).|Log Rank||Estimate via stratified Cox model with Efron's handling method with treatment as a covariate stratified by response to the induction therapy (CR/PR versus SD), tumor PD-L1 status (CPS ≥1 vs CPS \<1) and BRCA Status (BRCAm versus wild type BRCA gene).|||1.40|0.64|0.3903
72623387|NCT04191135|144777573|OTHER||Hazard Ratio (HR)|0.92|||||TWO_SIDED|95.0|0.59|1.43|||||Estimate based on stratified Cox model with Efron's method of tie handling with treatment as a covariate stratified by response to the induction therapy (CR or PR versus SD) and BRCA status (BRCAm versus BRCAwt).|||1.43|0.59|
72623388|NCT04191135|144777574|OTHER||Hazard Ratio (HR)|0.97|||||TWO_SIDED|95.0|0.53|1.76|||||Estimate based on stratified Cox model with Efron's method of tie handling with treatment as a covariate stratified by response to the induction therapy (CR or PR versus SD) and BRCA status (BRCAm versus BRCAwt).|||1.76|0.53|
72399905|NCT01064401|144307596|SUPERIORITY_OR_OTHER||Percent Reduction|45.0|||||TWO_SIDED|95.0|35.5|53.1||||||||53.1|35.5|
72623389|NCT04191135|144777575|OTHER||Hazard Ratio (HR)|0.7|||||TWO_SIDED|95.0|0.33|1.48|||||Estimate based on stratified Cox model with Efron's method of tie handling with treatment as a covariate stratified by response to the induction therapy (CR or PR versus SD) and tumor PD-L1 status (CPS≥1 vs CPS\<1).|||1.48|0.33|
72399906|NCT01064401|144307597|SUPERIORITY_OR_OTHER||Percent Reduction|54.4|||<|0.0001|TWO_SIDED|95.0|46.9|60.8||Estimated from a negative binomial regression model, adjusted for baseline volume of T2 hyperintense lesions, history of prior IFN beta use and baseline age (≤ 35 vs \> 35 years).|Negative Binomial Regression|The logarithmic transformation of the scan number of the MRI assessment was included in the model as the 'offset' parameter.||||60.8|46.9|< 0.0001
72399907|NCT01064401|144307598|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.84||||0.1575|TWO_SIDED|95.0|0.66|1.07||Based on Cox Proportional Hazards model, adjusted by baseline EDSS values as continuous variable, history of prior IFN beta use, and baseline age (≤ 35 vs \> 35 years).|Cox Proportional Hazard|||||1.07|0.66|0.1575
72508969|NCT04083222|144548329|SUPERIORITY||||||<|0.001||||||P-value was analyzed using ANOVA with treatment and screening ACE/ARB dose status stratification factor.|ANOVA|||Day 50||||<0.001
72508970|NCT04083222|144548329|SUPERIORITY||||||<|0.001||||||P-value was analyzed using ANOVA with treatment and screening ACE/ARB dose status stratification factor.|ANOVA|||Day 57||||<0.001
72508971|NCT04083222|144548329|SUPERIORITY||||||<|0.001||||||P-value was analyzed using ANOVA with treatment and screening ACE/ARB dose status stratification factor.|ANOVA|||Day 64||||<0.001
72508972|NCT04083222|144548329|SUPERIORITY||||||<|0.001||||||P-value was analyzed using ANOVA with treatment and screening ACE/ARB dose status stratification factor.|ANOVA|||Day 78||||<0.001
72508973|NCT04083222|144548329|SUPERIORITY||||||<|0.001||||||P-value was analyzed using ANOVA with treatment and screening ACE/ARB dose status stratification factor.|ANOVA|||Day 92||||<0.001
72508974|NCT04083222|144548329|SUPERIORITY|||||||0.106||||||P-value was analyzed using ANOVA with treatment and screening ACE/ARB dose status stratification factor.|ANOVA|||Day 120||||0.106
72508975|NCT04083222|144548329|SUPERIORITY|||||||0.318||||||P-value was analyzed using ANOVA with treatment and screening ACE/ARB dose status stratification factor.|ANOVA|||Day 141||||0.318
72399908|NCT01064401|144307598|SUPERIORITY_OR_OTHER||Percent Reduction|16.1|||||TWO_SIDED|95.0|-7.0|34.2||||||||34.2|-7.0|
72508976|NCT04083222|144548330|SUPERIORITY|||||||0.609||||||P-value was analyzed using ANOVA with treatment and screening ACE/ARB dose status stratification factor.|ANOVA|||Day 3||||0.609
72508977|NCT04083222|144548330|SUPERIORITY||||||<|0.001||||||P-value was analyzed using ANOVA with treatment and screening ACE/ARB dose status stratification factor.|ANOVA|||Day 8||||<0.001
72399909|NCT01064401|144307599|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.59|||<|0.0001|TWO_SIDED|95.0|0.5|0.69||Based on Cox proportional hazards model, adjusted for baseline relapse rate, history of prior IFN beta use, baseline EDSS (EDSS ≤ 2.5 vs EDSS \> 2.5) and baseline age (≤ 35 vs \> 35 years).|Cox Proportional Hazard|||||0.69|0.50|< 0.0001
72508978|NCT04083222|144548330|SUPERIORITY||||||<|0.001||||||P-value was analyzed using ANOVA with treatment and screening ACE/ARB dose status stratification factor.|ANOVA|||Day 15||||<0.001
72508979|NCT04083222|144548330|SUPERIORITY||||||<|0.001||||||P-value was analyzed using ANOVA with treatment and screening ACE/ARB dose status stratification factor.|ANOVA|||Day 22||||<0.001
72508980|NCT04083222|144548330|SUPERIORITY||||||<|0.001||||||P-value was analyzed using ANOVA with treatment and screening ACE/ARB dose status stratification factor.|ANOVA|||Day 29||||<0.001
72508981|NCT04083222|144548330|SUPERIORITY||||||<|0.001||||||P-value was analyzed using ANOVA with treatment and screening ACE/ARB dose status stratification factor.|ANOVA|||Day 36||||<0.001
72508982|NCT04083222|144548330|SUPERIORITY||||||<|0.001||||||P-value was analyzed using ANOVA with treatment and screening ACE/ARB dose status stratification factor.|ANOVA|||Day 43||||<0.001
72508983|NCT04083222|144548330|SUPERIORITY||||||<|0.001||||||P-value was analyzed using ANOVA with treatment and screening ACE/ARB dose status stratification factor.|ANOVA|||Day 50||||<0.001
72508984|NCT04083222|144548330|SUPERIORITY||||||<|0.001||||||P-value was analyzed using ANOVA with treatment and screening ACE/ARB dose status stratification factor.|ANOVA|||Day 64||||<0.001
72508985|NCT04083222|144548330|SUPERIORITY||||||<|0.001||||||P-value was analyzed using ANOVA with treatment and screening ACE/ARB dose status stratification factor.|ANOVA|||Day 78||||<0.001
72508986|NCT04083222|144548330|SUPERIORITY||||||<|0.001||||||P-value was analyzed using ANOVA with treatment and screening ACE/ARB dose status stratification factor.|ANOVA|||Day 92||||<0.001
72508987|NCT04083222|144548330|SUPERIORITY|||||||0.112||||||P-value was analyzed using ANOVA with treatment and screening ACE/ARB dose status stratification factor.|ANOVA|||Day 120||||0.112
72508988|NCT04083222|144548330|SUPERIORITY|||||||0.371||||||P-value was analyzed using ANOVA with treatment and screening ACE/ARB dose status stratification factor.|ANOVA|||Day 141||||0.371
72508989|NCT03103750|144548332|SUPERIORITY|||||||0.016|||||||Mixed Models Analysis|||The primary hypothesis of calcitriol-related differences in amphetamine-induced dopamine release was determined by significance of the main effect of medication (calcitriol vs. placebo) on %change in BPND (i.e., post-Amp relative to pre-Amp scans) at a threshold of p\<0.05.||||0.016
72508990|NCT03103750|144548334|SUPERIORITY|||||||0.55|||||||t-test, 2 sided|||||||0.55
72508991|NCT01128972|144548335|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|11.66|||<|0.0001|TWO_SIDED|95.0|7.09|16.24||No adjustments made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment, study period, and subject (random effect).|Difference is first named treatment minus second named treatment such that a positive difference favours the first named treatment.|Null hypothesis considered population means for the test dentifrice+ test MR treatment regimen and test dentifrice + sterile water rinse treatment regimen to be equal with respect to percent NER. Statistical tests were 2-sided with a significance level of 0.05.||16.24|7.09|<0.0001
72576831|NCT00261443|144680657|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.22||||0.085|TWO_SIDED|95.0|-0.46|0.03||Baseline: ANOVA model, controlling for treatment, mood stabilizer, and index mood episode. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 52 Comparison||0.03|-0.46|0.085
72399910|NCT01064401|144307599|SUPERIORITY_OR_OTHER||Percent Reduction in Risk of Relapse|40.9|||||TWO_SIDED|95.0|30.8|49.5||||||||49.5|30.8|
72399911|NCT01064401|144307600|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.76||||0.0176|TWO_SIDED|95.0|0.6|0.95||Based on logistic regression model, adjusted for baseline MSIS-29 physical score, baseline Beck Depression Inventory (BDI) score, history of prior IFN beta use, and baseline age (≤ 35 vs \> 35 years).|Regression, Logistic|||||0.95|0.60|0.0176
72399912|NCT01064401|144307600|SUPERIORITY_OR_OTHER||Percent Reduction in Odds of Worsening|24.2|||||TWO_SIDED|95.0|4.7|39.6||||||||39.6|4.7|
72399913|NCT02738151|144307627|NON_INFERIORITY|Non-inferiority of Toujeo vs Tresiba was demonstrated if the upper bound of the two-sided 95% confidence interval (CI) for the difference between groups was \<0.3%.|Least Square (LS) Mean difference|-0.05|STANDARD_ERROR_OF_MEAN|0.052|<|0.0001|TWO_SIDED|95.0|-0.152|0.051||Threshold for significance at 0.025 level.|Mixed Models Analysis||Toujeo vs. Tresiba|A hierarchical step-down testing procedure was used to control type 1 error. Analysis was performed using a MMRM approach with treatment groups, randomization strata, visit, and treatment-by-visit interaction as fixed categorical effects and baseline HbA1c value and baseline HbA1c value-by-visit interaction as continuous fixed covariates.||0.051|-0.152|<.0001
72399914|NCT02738151|144307627|SUPERIORITY||LS Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.052||0.3302|TWO_SIDED|95.0|-0.152|0.051|||Mixed Models Analysis|||Superiority of Toujeo over Tresiba was demonstrated if the upper bound of the two-sided 95% CI for the difference in the mean change in HbA1c from baseline to Week 24 between Toujeo over Tresiba on ITT population was \<0 (zero).||0.051|-0.152|0.3302
72399915|NCT03649711|144307662|OTHER|Post treatment values were compared using ANCOVA||||||0.002|||||||ANCOVA|||||||0.002
72399916|NCT03649711|144307662|OTHER|||||||0.18|||||||Wilcoxon (Mann-Whitney)|||mean changes in values were compared by Wilcoxon rank sum test adjusted for multiple comparisons (Bonferonni method) between CKD-ticagrelor arm, and the non-CKD controls||||0.18
72399917|NCT03649711|144307663|OTHER|||||||0.22|||||||ANCOVA|||CKD groups randomized were compared for post treatment values.||||0.22
72399918|NCT03939897|144307695|OTHER|This test is used to compare the survival distributions of different groups in a survival analysis. It's a nonparametric test.||||||0.506|||||||Log Rank|||||||0.5060
72399919|NCT03939897|144307698|OTHER|This test is used to compare the survival distributions of different groups in a survival analysis. It's a nonparametric test.||||||0.2989|||||||Log Rank|||||||0.2989
72399920|NCT00380978|144307705|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence|Risk Ratio (RR)|1.04||||0.65|TWO_SIDED|95.0|0.9|1.2|||Chi-squared, Corrected|||Group sample sizes of 800 in each group achieve 80% power to detect equivalence when the margin of equivalence extends from 0.1 to 0.25||1.20|0.90|0.65
72399921|NCT00380978|144307706|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.98||||0.63|TWO_SIDED|95.0|0.8|1.2|||Chi-squared|||There rate of instrumented vaginal delivery will be equal in both groups.||1.20|0.80|0.63
72399922|NCT00380978|144307707|SUPERIORITY_OR_OTHER|||||||0.047||95.0|||||Log Rank|||||||0.047
72399923|NCT00380978|144307708|SUPERIORITY_OR_OTHER|||||||0.35||95.0|||||Chi-squared|||||||0.35
72399924|NCT00380978|144307709|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-4.0|||<|0.005|TWO_SIDED|95.0|-4.0|-3.0|||Wilcoxon (Mann-Whitney)|||||-3|-4|<0.005
72399925|NCT00380978|144307710|SUPERIORITY_OR_OTHER||||||<|0.005||95.0|||||Chi-squared, Corrected|||||||<0.005
72399926|NCT00380978|144307711|SUPERIORITY_OR_OTHER|||||||0.11||95.0|||||Fisher Exact|||||||0.11
72399927|NCT00380978|144307712|SUPERIORITY_OR_OTHER||||||<|0.005||95.0|||||Chi-squared, Corrected|||||||<0.005
72399928|NCT01729754|144307715|SUPERIORITY||Difference in percentages|59.8|||<|0.001|TWO_SIDED|95.0|52.9|65.9|||Cochran-Mantel-Haenszel|Stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.|Difference and confidence intervals (CIs) are calculated using Miettinen-Nurminen stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no) with sample size weights.|||65.9|52.9|<0.001
72399929|NCT01729754|144307715|SUPERIORITY||Difference in percentages|55.5|||<|0.001|TWO_SIDED|95.0|48.3|61.8|||Cochran-Mantel-Haenszel|Stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.|Difference and CIs are calculated using Miettinen-Nurminen stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no) with sample size weights.|||61.8|48.3|<0.001
72399930|NCT01729754|144307716|SUPERIORITY||Difference in percentages|54.7|||<|0.001|TWO_SIDED|95.0|47.9|60.8|||Cochran-Mantel-Haenszel|Stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.|Difference and CIs are calculated using Miettinen-Nurminen stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no) with sample size weights.|||60.8|47.9|<0.001
72399931|NCT01729754|144307716|SUPERIORITY||Difference in percentages|50.2|||<|0.001|TWO_SIDED|95.0|43.2|56.5||Stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.|Cochran-Mantel-Haenszel||Difference and CIs are calculated using Miettinen-Nurminen stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no) with sample size weights.|||56.5|43.2|<0.001
72399932|NCT01729754|144307719|SUPERIORITY||Difference in percentages|19.2|||<|0.001|TWO_SIDED|95.0|11.5|26.7||Stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.|Cochran-Mantel-Haenszel||Difference and CIs are calculated using Miettinen-Nurminen stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no) with sample size weights.|||26.7|11.5|<0.001
72399933|NCT01729754|144307719|SUPERIORITY||Difference in percentages|20.1|||<|0.001|TWO_SIDED|95.0|12.4|27.6||Stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.|Cochran-Mantel-Haenszel||Difference and CIs are calculated using Miettinen-Nurminen stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no) with sample size weights.|||27.6|12.4|<0.001
72399934|NCT01729754|144307722|SUPERIORITY||Difference in percentages|24.1|||<|0.001|TWO_SIDED|95.0|16.2|31.7|||Cochran-Mantel-Haenszel|Stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.|Difference and CIs are calculated using Miettinen-Nurminen stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no) with sample size weights.|||31.7|16.2|<0.001
72478164|NCT00190749|144482458|SUPERIORITY_OR_OTHER|||||||0.714||95.0|||||Pearson's correlation coefficient|||||||0.714
72478165|NCT00190749|144482459|SUPERIORITY_OR_OTHER|||||||0.672||95.0|||||Pearson's correlation coefficient|||||||0.672
72478166|NCT00190749|144482459|SUPERIORITY_OR_OTHER|||||||0.191||95.0|||||Pearson's correlation coefficient|||||||0.191
72478167|NCT00190749|144482460|SUPERIORITY_OR_OTHER|||||||0.994||95.0|||||Pearson's correlation coefficient|||||||0.994
72478168|NCT00190749|144482460|SUPERIORITY_OR_OTHER|||||||0.456||95.0|||||Pearson's correlation coefficient|||||||0.456
72478169|NCT00190749|144482461|SUPERIORITY_OR_OTHER|||||||0.454||95.0|||||Pearson's correlation coefficient|||||||0.454
72478170|NCT00190749|144482461|SUPERIORITY_OR_OTHER|||||||0.974||95.0|||||Pearson's correlation coefficient|||||||0.974
72478171|NCT00190749|144482462|SUPERIORITY_OR_OTHER|||||||0.249||95.0|||||Pearson's correlation coefficient|||||||0.249
72478172|NCT00190749|144482462|SUPERIORITY_OR_OTHER|||||||0.163||95.0|||||Pearson's correlation coefficient|||||||0.163
72478173|NCT00190749|144482463|SUPERIORITY_OR_OTHER|||||||0.201||95.0|||||Pearson's correlation coefficient|||||||0.201
72566447|NCT02697773|144663274|SUPERIORITY||Least Square Mean Difference|-1.07|STANDARD_ERROR_OF_MEAN|0.21|<|0.0001|TWO_SIDED|95.0|-1.49|-0.66|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC average score and baseline diary average pain as covariates, and study site as a random effect.||-0.66|-1.49|<.0001
72399935|NCT01729754|144307722|SUPERIORITY||Difference in percentages|19.6|||<|0.001|TWO_SIDED|95.0|11.7|27.3|||Cochran-Mantel-Haenszel|Stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.|Difference and CIs are calculated using Miettinen-Nurminen stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no) with sample size weights|||27.3|11.7|<0.001
72478174|NCT00190749|144482463|SUPERIORITY_OR_OTHER|||||||0.168||95.0|||||Pearson's correlation coefficient|||||||0.168
72478175|NCT00190749|144482464|SUPERIORITY_OR_OTHER|||||||0.793||95.0|||||Pearson's correlation coefficient|||||||0.793
72478176|NCT00190749|144482464|SUPERIORITY_OR_OTHER|||||||0.777||95.0|||||Pearson's correlation coefficient|||||||0.777
72478177|NCT00190749|144482465|SUPERIORITY_OR_OTHER|||||||0.815||95.0|||||Pearson's correlation coefficient|||||||0.815
72478178|NCT00190749|144482465|SUPERIORITY_OR_OTHER|||||||0.675||95.0|||||Pearson's correlation coefficient|||||||0.675
72478179|NCT00190749|144482466|SUPERIORITY_OR_OTHER|||||||0.393||95.0|||||Pearson's correlation coefficient|||Change in Eating Behavior Item 1||||0.393
72478180|NCT00190749|144482466|SUPERIORITY_OR_OTHER|||||||0.033||95.0|||||Pearson's correlation coefficient|||Change in Eating Behavior Item 1||||0.033
72478181|NCT00190749|144482466|SUPERIORITY_OR_OTHER|||||||0.392||95.0|||||Pearson's correlation coefficient|||Change in Eating Behavior Item 2||||0.392
72478182|NCT00190749|144482466|SUPERIORITY_OR_OTHER|||||||0.129||95.0|||||Pearson's correlation coefficient|||Change in Eating Behavior Item 2||||0.129
72478183|NCT00190749|144482466|SUPERIORITY_OR_OTHER|||||||0.956||95.0|||||Pearson's correlation coefficient|||Change in Eating Bahavior Item 3||||0.956
72478184|NCT00190749|144482466|SUPERIORITY_OR_OTHER|||||||0.846||95.0|||||Pearson's correlation coefficient|||Change in Eating Behavior Item 3||||0.846
72478185|NCT00190749|144482466|SUPERIORITY_OR_OTHER|||||||0.675||95.0|||||Pearson's correlation coefficient|||Change in Eating Behavior Item 4||||0.675
72478186|NCT00190749|144482466|SUPERIORITY_OR_OTHER|||||||0.306||95.0|||||Pearson's correlation coefficient|||Change in Eating Behavior Item 4||||0.306
72478187|NCT00190749|144482466|SUPERIORITY_OR_OTHER|||||||0.468||95.0|||||Pearson's correlation coefficient|||Change in Eating Behavior Item 5||||0.468
72478188|NCT00190749|144482466|SUPERIORITY_OR_OTHER|||||||0.739||95.0|||||Pearson's correlation coefficient|||Change in Eating Behavior Item 5||||0.739
72478189|NCT00190749|144482466|SUPERIORITY_OR_OTHER|||||||0.404||95.0|||||Pearson's correlation coefficient|||Change in Eating Behavior Item 6||||0.404
72478190|NCT00190749|144482466|SUPERIORITY_OR_OTHER|||||||0.711||95.0|||||Pearson's correlation coefficient|||Change in Eating Behavior Item 6||||0.711
72478191|NCT00190749|144482466|SUPERIORITY_OR_OTHER|||||||0.281||95.0|||||Pearson's correlation coefficient|||Change in Eating Behavior Item 7||||0.281
72478192|NCT00190749|144482466|SUPERIORITY_OR_OTHER|||||||0.805||95.0|||||Pearson's correlation coefficient|||Change in Eating Behavior Item 7||||0.805
72478193|NCT00190749|144482466|SUPERIORITY_OR_OTHER|||||||0.844||95.0|||||Pearson's correlation coefficient|||Change in Eating Behavior Item 8||||0.844
72478194|NCT00190749|144482466|SUPERIORITY_OR_OTHER|||||||0.359||95.0|||||Pearson's correlation coefficient|||Change in Eating Bahavior Item 8||||0.359
72478195|NCT00190749|144482466|SUPERIORITY_OR_OTHER|||||||0.642||95.0|||||Pearson's correlation coefficient|||Change in Eating Behavior Item 9||||0.642
72478196|NCT00190749|144482466|SUPERIORITY_OR_OTHER|||||||0.043||95.0|||||Pearson's correlation coefficient|||Change in Eating Behavior Item 9||||0.043
72478197|NCT00190749|144482467|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on Least Squares Mean (LSMean) change||||||<.001
72478198|NCT00190749|144482467|SUPERIORITY_OR_OTHER|||||||0.019||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||||||0.019
72478199|NCT00190749|144482467|SUPERIORITY_OR_OTHER|||||||0.065||95.0|||||ANCOVA|Overall p-values are from Type 3 sums of squares ANCOVA, Model: Change =Baseline Treatment Pooled Investigator||||||0.065
72478200|NCT00190749|144482468|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|With group p-values are from t-tests on LSMean change||||||<.001
72478201|NCT00190749|144482468|SUPERIORITY_OR_OTHER|||||||0.013||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||||||0.013
72478202|NCT00190749|144482468|SUPERIORITY_OR_OTHER|||||||0.076||95.0|||||ANCOVA|Overall p-values are from Type 3 sums of squares ANCOVA, Model: Change = Baseline Treatment Pooled Investigator||||||0.076
72478203|NCT00190749|144482469|SUPERIORITY_OR_OTHER|||||||0.007||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||||||0.007
72478204|NCT00190749|144482469|SUPERIORITY_OR_OTHER|||||||0.266||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||||||0.266
72478205|NCT00190749|144482469|SUPERIORITY_OR_OTHER|||||||0.239||95.0|||||ANCOVA|Overall p-values are from Type 3 sums of squares ANCOVA, Model: Change = Baseline Treatment Pooled Investigator||||||0.239
72623390|NCT04191135|144777576|OTHER||Hazard Ratio (HR)|0.81|||||TWO_SIDED|95.0|0.28|2.37|||||Estimate based on stratified Cox model with Efron's method of tie handling with treatment as a covariate stratified by response to the induction therapy (CR or PR versus SD) and tumor PD-L1 status (CPS≥1 vs CPS\<1).|||2.37|0.28|
72399936|NCT01729754|144307725|SUPERIORITY||Difference in percentages|35.3|||<|0.001|TWO_SIDED|95.0|29.2|41.1|||Cochran-Mantel-Haenszel|Stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.|Difference and CIs are calculated using Miettinen-Nurminen stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no) with sample size weights.|||41.1|29.2|<0.001
72399937|NCT01729754|144307725|SUPERIORITY||Difference in percentages|37.5|||<|0.001|TWO_SIDED|95.0|31.1|43.4|||Cochran-Mantel-Haenszel|Stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.|Difference and CIs are calculated using Miettinen-Nurminen stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no) with sample size weights|||43.4|31.1|<0.001
72399938|NCT01729754|144307725|SUPERIORITY||Difference in percentages|15.2|||<|0.001|TWO_SIDED|95.0|8.3|22.1|||Cochran-Mantel-Haenszel|Stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.|Difference and CIs are calculated using Miettinen-Nurminen stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no) with sample size weights.|||22.1|8.3|<0.001
72399939|NCT01729754|144307725|SUPERIORITY||Difference in percentages|17.4|||<|0.001|TWO_SIDED|95.0|10.3|24.4|||Cochran-Mantel-Haenszel|Stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.|Difference and CIs are calculated using Miettinen-Nurminen stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no) with sample size weights.|||24.4|10.3|<0.001
72399940|NCT01729754|144307726|OTHER||Difference in percentages|27.1|||<|0.001|TWO_SIDED|95.0|19.1|34.7||Stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.|Cochran-Mantel-Haenszel||Difference and CIs are calculated using Miettinen-Nurminen stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no) with sample size weights.|||34.7|19.1|<0.001
72478206|NCT00190749|144482470|SUPERIORITY_OR_OTHER|||||||0.274||95.0|||||t-test, 2 sided|Within group p-vales are from t-tests on LSMean change||||||0.274
72478207|NCT00190749|144482470|SUPERIORITY_OR_OTHER|||||||0.105||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change.||||||0.105
72478208|NCT00190749|144482470|SUPERIORITY_OR_OTHER|||||||0.609||95.0|||||ANCOVA|Overall p-values are from Type 3 sums of squares ANCOVA, Model: Change= Baseline Treatment Pooled Investigator||||||0.609
72623391|NCT04191135|144777577|SUPERIORITY||Difference in Least Squares Means|-3.28||||0.143|TWO_SIDED|95.0|-7.69|1.12|||cLDA|cLDA model with PRO scores as the response variable with covariates for treatment by time interaction, stratification factors as covariates.||||1.12|-7.69|0.1430
72478209|NCT00190749|144482471|SUPERIORITY_OR_OTHER|||||||0.406||95.0|||||t-test, 2 sided|With group p-values are from t-tests on LSMean change||||||0.406
72478210|NCT00190749|144482471|SUPERIORITY_OR_OTHER|||||||0.011||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||||||0.011
72478211|NCT00190749|144482471|SUPERIORITY_OR_OTHER|||||||0.076||95.0|||||ANCOVA|Overall group p-values are from Type 3 sums of squares ANCOVA, Model: Change=Baseline Treatment Pooled Investigator||||||0.076
72478212|NCT00190749|144482472|SUPERIORITY_OR_OTHER|||||||0.456||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||||||0.456
72478213|NCT00190749|144482472|SUPERIORITY_OR_OTHER|||||||0.712||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||||||0.712
72478214|NCT00190749|144482472|SUPERIORITY_OR_OTHER|||||||0.689||95.0|||||ANCOVA|Overall p-values are from Type 3 sums of squares ANCOVA, Model: Change= Baseline Treatment Pooled Investigator||||||0.689
72478215|NCT00190749|144482473|SUPERIORITY_OR_OTHER|||||||0.111||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean||Total Score||||0.111
72478216|NCT00190749|144482473|SUPERIORITY_OR_OTHER|||||||0.159||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean changes||Total Score||||0.159
72478217|NCT00190749|144482473|SUPERIORITY_OR_OTHER|||||||0.951||95.0|||||ANCOVA|Overall p-values are from Type 3 sums of squares ANCOVA, Model: Change =Baseline Treatment Pooled Investigator||Total Score||||0.951
72478218|NCT00190749|144482473|SUPERIORITY_OR_OTHER|||||||0.012||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||Positive Subscale||||0.012
72478219|NCT00190749|144482473|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||t-test, 2 sided|With group p-values are from t-tests on LSMean||Positive subscale||||0.002
72478220|NCT00190749|144482473|SUPERIORITY_OR_OTHER|||||||0.467||95.0|||||ANCOVA|Overall p-values are from Type 3 sums of squares ANCOVA, Model: Change =Baseline Treatment Pooled Investigator||Positive subscale||||0.467
72478221|NCT00190749|144482473|SUPERIORITY_OR_OTHER|||||||0.365||95.0|||||t-test, 2 sided|With group p-values are from t-tests on LSMean change||Negative subscale||||0.365
72478222|NCT00190749|144482473|SUPERIORITY_OR_OTHER|||||||0.846||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||Negative subscale||||0.846
72478223|NCT00190749|144482473|SUPERIORITY_OR_OTHER|||||||0.559||95.0|||||ANCOVA|Overall p-values are from Type 3 sums of squares ANCOVA, Model: Change=Baseline Treatment Pooled Investigator||Negative subscale||||0.559
72478224|NCT00190749|144482473|SUPERIORITY_OR_OTHER|||||||0.15||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||Anxiety-Depression subscale||||0.150
72478225|NCT00190749|144482473|SUPERIORITY_OR_OTHER|||||||0.612||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||Anxiety-Depression subscale||||0.612
72478226|NCT00190749|144482473|SUPERIORITY_OR_OTHER|||||||0.475||95.0|||||ANCOVA|Overall p-values are from Type 3 sums of squares ANCOVA, Model: Change=Baseline Treatment Pooled Investigator||Anxiety-Depression subscale||||0.475
72478227|NCT00190749|144482474|SUPERIORITY_OR_OTHER|||||||0.012||95.0||||Within group p-values are from t-tests on LSMean change|t-test, 2 sided|||||||.012
72478228|NCT00190749|144482474|SUPERIORITY_OR_OTHER|||||||0.01||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||||||0.010
72478229|NCT00190749|144482474|SUPERIORITY_OR_OTHER|||||||0.76||95.0|||||ANCOVA|Overall p-values are from Type 3 sums of square ANCOVA, Model: Change=Baseline Treatment Pooled Investigator||||||0.760
72478230|NCT00190749|144482475|SUPERIORITY_OR_OTHER|||||||0.943||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||||||0.943
72478231|NCT00190749|144482475|SUPERIORITY_OR_OTHER|||||||0.763||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||||||0.763
72478232|NCT00190749|144482475|SUPERIORITY_OR_OTHER|||||||0.832||95.0|||||ANCOVA|Overall p-values are from Type 3 sums of squares ANCOVA, Model: Change=Baseline Treatment Pooled Investigator||||||0.832
72478233|NCT00190749|144482476|SUPERIORITY_OR_OTHER|||||||0.623||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||||||0.623
72478234|NCT00190749|144482476|SUPERIORITY_OR_OTHER|||||||0.853||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||||||0.853
72478235|NCT00190749|144482476|SUPERIORITY_OR_OTHER|||||||0.591||95.0|||||ANCOVA|Overall p-values are from Type 3 sums of squares ANCOVA, Model: Change=Baseline Treatment Pooled Investigator||||||0.591
72478236|NCT00190749|144482477|SUPERIORITY_OR_OTHER|||||||0.302||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||||||0.302
72478237|NCT00190749|144482477|SUPERIORITY_OR_OTHER|||||||0.922||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||||||0.922
72478238|NCT00190749|144482477|SUPERIORITY_OR_OTHER|||||||0.479||95.0|||||ANCOVA|Overall group p-values are from Type 3 sums of squares ANCOVA, Model: Change=Baseline Treatment Pooled Investigator||||||0.479
72623392|NCT04191135|144777578|SUPERIORITY||Difference in Least Squares Means|-0.16||||0.9454|TWO_SIDED|95.0|-4.89|4.56|||cLDA|cLDA model with PRO scores as the response variable with covariates for treatment by time interaction, stratification factors as covariates.||||4.56|-4.89|0.9454
72478239|NCT00190749|144482478|SUPERIORITY_OR_OTHER|||||||0.004||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||Item 1||||0.004
72478240|NCT00190749|144482478|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||Item 1||||0.001
72478241|NCT00190749|144482478|SUPERIORITY_OR_OTHER|||||||0.549||95.0|||||ANCOVA|Overall p-values are from Type 3 sums of squares, ANCOVA, Model: Change=Baseline Treatment Pooled Investigator||Item 1||||0.549
72478242|NCT00190749|144482478|SUPERIORITY_OR_OTHER|||||||0.011||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||Item 2||||0.011
72478243|NCT00190749|144482478|SUPERIORITY_OR_OTHER|||||||0.009||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||Item 2||||0.009
72478244|NCT00190749|144482478|SUPERIORITY_OR_OTHER|||||||0.793||95.0|||||ANCOVA|Overall p-values are from Type 3 sums of squares ANCOVA, Model: Change=Baseline Treatment Pooled Investigator||Item 2||||0.793
72478245|NCT00190749|144482478|SUPERIORITY_OR_OTHER|||||||0.045||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||Item 3||||0.045
72478246|NCT00190749|144482478|SUPERIORITY_OR_OTHER|||||||0.027||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||Item 3||||0.027
72478247|NCT00190749|144482478|SUPERIORITY_OR_OTHER|||||||0.699||95.0|||||ANCOVA|Overall p-values are from Type 3 sums of squares ANCOVA, Model: Change=Baseline Treatment Pooled Investigator||Item 3||||0.699
72478248|NCT00190749|144482478|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||Item 4||||0.002
72478249|NCT00190749|144482478|SUPERIORITY_OR_OTHER|||||||0.019||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||ITem 4||||0.019
72478250|NCT00190749|144482478|SUPERIORITY_OR_OTHER|||||||0.733||95.0|||||ANCOVA|Overall p-values are from Type 3 sums of squares ANCOVA, Model: Change=Baseline Treatment Pooled Investigator||Item 4||||0.733
72478251|NCT00190749|144482478|SUPERIORITY_OR_OTHER|||||||0.034||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||Item 5||||0.034
72478252|NCT00190749|144482478|SUPERIORITY_OR_OTHER|||||||0.235||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||Item 5||||0.235
72478253|NCT00190749|144482478|SUPERIORITY_OR_OTHER|||||||0.532||95.0|||||ANCOVA|Overall p-values are from Type 3 sums of squares ANCOVA, Model: Change=Baseline Treatment Pooled Investigator||Item 5||||0.532
72478254|NCT00190749|144482478|SUPERIORITY_OR_OTHER|||||||0.242||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||Item 6||||0.242
72623393|NCT04191135|144777579|SUPERIORITY||Difference in Least Squares Means|2.08||||0.4351|TWO_SIDED|95.0|-3.16|7.31|||cLDA|cLDA model with PRO scores as the response variable with covariates for treatment by time interaction, stratification factors as covariates.||||7.31|-3.16|0.4351
72623394|NCT04191135|144777580|SUPERIORITY||Difference in Least Squares Means|0.93||||0.5588|TWO_SIDED|95.0|-2.2|4.06|||cLDA|cLDA model with PRO scores as the response variable with covariates for treatment by time interaction, stratification factors as covariates.||||4.06|-2.20|0.5588
72623395|NCT04191135|144777581|SUPERIORITY||Difference in Least Squares Means|-0.37||||0.8408|TWO_SIDED|95.0|-4.03|3.28|||cLDA|cLDA model with PRO scores as the response variable with covariates for treatment by time interaction, stratification factors as covariates.||||3.28|-4.03|0.8408
72478255|NCT00190749|144482478|SUPERIORITY_OR_OTHER|||||||0.186||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||Item 6||||0.186
72478256|NCT00190749|144482478|SUPERIORITY_OR_OTHER|||||||0.799||95.0|||||ANCOVA|Overall p-values are from Type 3 sums of squares ANCOVA, Model: Change=Baseline Treatment Pooled Investigator||Item 6||||0.799
72478257|NCT00190749|144482478|SUPERIORITY_OR_OTHER|||||||0.097||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||Item 7||||0.097
72478258|NCT00190749|144482478|SUPERIORITY_OR_OTHER|||||||0.214||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||Item 7||||0.214
72478259|NCT00190749|144482478|SUPERIORITY_OR_OTHER|||||||0.827||95.0|||||ANCOVA|Overall p-values are from Type 3 sums of squares ANCOVA, Model: Change=Baseline Treatment Pooled Investigator||Item 7||||0.827
72478260|NCT00190749|144482478|SUPERIORITY_OR_OTHER|||||||0.151||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||Item 8||||0.151
72478261|NCT00190749|144482478|SUPERIORITY_OR_OTHER|||||||0.071||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||Item 8||||0.071
72478262|NCT00190749|144482478|SUPERIORITY_OR_OTHER|||||||0.629||95.0|||||ANCOVA|Overall p-values are from Type 3 sums of squares ANCOVA, Model: Change=Baseline Treatment Pooled Investigator||Item 8||||0.629
72399941|NCT01729754|144307726|OTHER||Difference in percentages|24.9|||<|0.001|TWO_SIDED|95.0|17.0|32.6|||Cochran-Mantel-Haenszel|Stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.|Difference and CIs are calculated using Miettinen-Nurminen stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no) with sample size weights.|||32.6|17.0|<0.001
72399942|NCT01729754|144307729|SUPERIORITY||Difference in percentages|11.7|||<|0.001|TWO_SIDED|95.0|7.8|16.0|||Cochran-Mantel-Haenszel|Stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.|Difference and CIs are calculated using Miettinen-Nurminen stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no) with sample size weights.|||16.0|7.8|<0.001
72399943|NCT01729754|144307729|SUPERIORITY||Difference in percentages|12.4|||<|0.001|TWO_SIDED|95.0|8.5|16.6|||Cochran-Mantel-Haenszel|Stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.|Difference and CIs are calculated using Miettinen-Nurminen stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no) with sample size weights.|||16.6|8.5|<0.001
72478263|NCT00190749|144482478|SUPERIORITY_OR_OTHER|||||||0.036||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||Item 9||||0.036
72478264|NCT00190749|144482478|SUPERIORITY_OR_OTHER|||||||0.112||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||Item 9||||0.112
72478265|NCT00190749|144482478|SUPERIORITY_OR_OTHER|||||||0.806||95.0|||||ANCOVA|Overall p-values are from Type 3 sums of squares ANCOVA, Model: Change=Baseline Treatment Pooled Investigator||Item 9||||0.806
72478266|NCT00190749|144482479|SUPERIORITY_OR_OTHER|||||||0.156||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||||||0.156
72478267|NCT00190749|144482479|SUPERIORITY_OR_OTHER|||||||0.829||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||||||0.829
72478268|NCT00190749|144482479|SUPERIORITY_OR_OTHER|||||||0.352||95.0|||||ANCOVA|Overall p-values are from Type 3 sums of squares ANCOVA, Model: Change=Baseline Treatment Pooled Investigator||||||0.352
72478269|NCT00190749|144482480|SUPERIORITY_OR_OTHER|||||||0.74||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||||||0.740
72478270|NCT00190749|144482480|SUPERIORITY_OR_OTHER|||||||0.76||95.0|||||t-test, 2 sided|Within group p-values are frm t-tests on LSMean change||||||0.760
72478271|NCT00190749|144482480|SUPERIORITY_OR_OTHER|||||||0.997||95.0|||||ANCOVA|Overall p-values are from Type 3 sums of squares ANCOVA, Model: Change=Baseline Treatment Pooled Investigator||||||0.997
72478272|NCT00190749|144482481|SUPERIORITY_OR_OTHER|||||||0.176||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||||||0.176
72478273|NCT00190749|144482481|SUPERIORITY_OR_OTHER|||||||0.237||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||||||0.237
72508992|NCT01128972|144548335|SUPERIORITY_OR_OTHER||Adjusted Mean DIfference|26.6|||<|0.0001|TWO_SIDED|95.0|22.02|31.18||No adjustments made for multiple comparisons as primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment, study period, and subject (random effect).|Difference is first named treatment minus second named treatment such that a positive difference favours the first named treatment.|Null hypothesis considered population means for the test dentifrice+ test MR treatment regimen and reference dentifrice + sterile water rinse treatment regimen to be equal with respect to percent NER. Statistical tests were 2-sided with a significance level of 0.05.||31.18|22.02|<0.0001
72623396|NCT04191135|144777582|SUPERIORITY||Difference in Least Squares Means|-1.34||||0.795|TWO_SIDED|95.0|-11.63|8.95|||cLDA|cLDA model with PRO scores as the response variable with covariates for treatment by time interaction, stratification factors as covariates.||||8.95|-11.63|0.7950
72478274|NCT00190749|144482481|SUPERIORITY_OR_OTHER|||||||0.996||95.0|||||ANCOVA|Overall p-values are from Type 3 sums of squares ANCOVA, Model: Change=Baseline Treatment Pooled Investigator||||||0.996
72478275|NCT00190749|144482482|SUPERIORITY_OR_OTHER|||||||0.027||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||||||0.027
72478276|NCT00190749|144482482|SUPERIORITY_OR_OTHER|||||||0.545||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||||||0.545
72478277|NCT00190749|144482482|SUPERIORITY_OR_OTHER|||||||0.024||95.0|||||ANCOVA|Overall p-values are from Type 3 sums of squares ANCOVA, Model: Change=Baseline Treatment Pooled Investigator||||||0.024
72478278|NCT00190749|144482483|SUPERIORITY_OR_OTHER|||||||0.009||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||HDL particles, total||||0.009
72478279|NCT00190749|144482483|SUPERIORITY_OR_OTHER|||||||0.959||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||HDL particles, total||||0.959
72478280|NCT00190749|144482483|SUPERIORITY_OR_OTHER|||||||0.038||95.0||||Overall p-values are from Type 3 sums of squares ANCOVA, Model: Change=Baseline TReatment Pooled Investigator|ANCOVA|||HDL particles, total||||0.038
72478281|NCT00190749|144482483|SUPERIORITY_OR_OTHER|||||||0.013||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||IDL||||0.013
72478282|NCT00190749|144482483|SUPERIORITY_OR_OTHER|||||||0.928||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||IDL||||0.928
72478283|NCT00190749|144482483|SUPERIORITY_OR_OTHER|||||||0.049||95.0|||||ANCOVA|Overall p-values are from Type 3 sums of squares ANCOVA, Model: Change=Baseline Treatment Pooled Investigator||IDL||||0.049
72478284|NCT00190749|144482483|SUPERIORITY_OR_OTHER|||||||0.009||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||Medium small LDL||||0.009
72478285|NCT00190749|144482483|SUPERIORITY_OR_OTHER|||||||0.662||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||Medium small LDL||||0.662
72478286|NCT00190749|144482483|SUPERIORITY_OR_OTHER|||||||0.12||95.0|||||ANCOVA|Overall p-values are from Type 3 sums of squares ANCOVA, Model: Change=Baseline Treatment Pooled Investigator||Medium small LDL||||0.12
72478287|NCT00190749|144482483|SUPERIORITY_OR_OTHER|||||||0.099||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||Small LDL||||0.099
72478288|NCT00190749|144482483|SUPERIORITY_OR_OTHER|||||||0.304||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||Small LDL||||0.304
72478289|NCT00190749|144482483|SUPERIORITY_OR_OTHER|||||||0.024||95.0|||||ANCOVA|Overall p-values are from Type 3 sums of squares ANCOVA, Model: Change=Baseline Treatment Pooled Investigator||Small LDL||||0.024
72478290|NCT00190749|144482483|SUPERIORITY_OR_OTHER|||||||0.176||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||Very small LDL||||0.176
72478291|NCT00190749|144482483|SUPERIORITY_OR_OTHER|||||||0.246||95.0|||||t-test, 2 sided|Withn group p-values are from t-tests on LSMean change||Very small LDL||||0.246
72478292|NCT00190749|144482483|SUPERIORITY_OR_OTHER|||||||0.033||95.0||||Overall p-values are from Type 3 sums of squares ANCOVA, Model: Change=Baseline Treatment Pooled Investigator|ANCOVA|||Very small LDL||||0.033
72478293|NCT00190749|144482483|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||VLDL mean particle size||||<0.001
72478294|NCT00190749|144482483|SUPERIORITY_OR_OTHER|||||||0.047||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||VLDL mean particle size||||0.047
72478295|NCT00190749|144482483|SUPERIORITY_OR_OTHER|||||||0.221||95.0|||||ANCOVA|Overall p-values are from Type 3 sums of squares ANCOVA, Model: Change=Baseline Treatment Pooled Investigator||VLDL mean particle size||||0.221
72478296|NCT01090427|144482484|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|Stratified by body weight (less than or equal to 60 kg vs greater than 60 kg).||||||<0.001
72478297|NCT01090427|144482484|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|Stratified by body weight (less than or equal to 60 kg vs greater than 60 kg).||||||<0.001
72478298|NCT01090427|144482485|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|Stratified by body weight (less than or equal to 60 kg vs greater than 60 kg).||||||<0.001
72478299|NCT01090427|144482485|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|Stratified by body weight (less than or equal to 60 kg vs greater than 60 kg).||||||<0.001
72508993|NCT01128972|144548335|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|37.17|||<|0.0001|TWO_SIDED|95.0|32.59|41.74||No adjustments made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment, study period, and subject (random effect).|Difference is first named treatment minus second named treatment such that a positive difference favours the first named treatment.|Null hypothesis considered population means for the test dentifrice+ test MR treatment regimen and placebo dentifrice + sterile water rinse treatment regimen to be equal with respect to percent NER. Statistical tests were 2-sided with a significance level of 0.05.||41.74|32.59|<0.0001
72576832|NCT00261443|144680660|SUPERIORITY_OR_OTHER_LEGACY||Difference|0.04||||0.774|TWO_SIDED|95.0|-0.25|0.33||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 4 Comparison||0.33|-0.25|0.774
72478300|NCT01090427|144482486|SUPERIORITY_OR_OTHER|||||||0.003|||||||ANOVA on van der Waerden normal Score|Treatment and baseline weight \[less than or equal to 60 kg vs greater than 60 kg\] will be used as factors in the model.||||||0.003
72478301|NCT01090427|144482486|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA on van der Waerden normal Score|Treatment and baseline weight \[less than or equal to 60 kg vs greater than 60 kg\] will be used as factors in the model.||||||<0.001
72478302|NCT01090427|144482487|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|Stratified by body weight (less than or equal to 60 kg vs greater than 60 kg).||||||<0.001
72478303|NCT01090427|144482487|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|Stratified by body weight (less than or equal to 60 kg vs greater than 60 kg).||||||<0.001
72478304|NCT01090427|144482488|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|Stratified by body weight (less than or equal to 60 kg vs greater than 60 kg).||PGA of 0||||<0.001
72478305|NCT01090427|144482488|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|Stratified by body weight (less than or equal to 60 kg vs greater than 60 kg).||PGA of 0||||<0.001
72478306|NCT01090427|144482488|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|Stratified by body weight (less than or equal to 60 kg vs greater than 60 kg).||PGA of 0, 1, or 2||||<0.001
72478307|NCT01090427|144482488|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|Stratified by body weight (less than or equal to 60 kg vs greater than 60 kg).||PGA of 0, 1, or 2||||<0.001
72478308|NCT01090427|144482489|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|Stratified by body weight (less than or equal to 60 kg vs greater than 60 kg).||PASI 50 responders||||<0.001
72478309|NCT01090427|144482489|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|Stratified by body weight (less than or equal to 60 kg vs greater than 60 kg).||PASI 50 responders||||<0.001
72478310|NCT01090427|144482489|SUPERIORITY_OR_OTHER|||||||0.014|||||||Cochran-Mantel-Haenszel|Stratified by body weight (less than or equal to 60 kg vs greater than 60 kg).||Participants with PASI score of 0||||0.014
72478311|NCT01090427|144482489|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|Stratified by body weight (less than or equal to 60 kg vs greater than 60 kg).||Participants with PASI score of 0||||<0.001
72478312|NCT01090427|144482490|SUPERIORITY_OR_OTHER|||||||0.003|||||||ANOVA on van der Waerden normal Score|Treatment and baseline weight \[less than or equal to 60 kg vs greater than 60 kg\] were used as factors in the model.||PedsQL Total Scale Score||||0.003
72478313|NCT01090427|144482490|SUPERIORITY_OR_OTHER|||||||0.028|||||||ANOVA on van der Waerden normal Score|Treatment and baseline weight \[less than or equal to 60 kg vs greater than 60 kg\] were used as factors in the model.||PedsQL Total Scale Score||||0.028
72478314|NCT01090427|144482490|SUPERIORITY_OR_OTHER|||||||0.005|||||||ANOVA on van der Waerden normal Score|Treatment and baseline weight \[less than or equal to 60 kg vs greater than 60 kg\] were used as factors in the model.||PedsQL Psychosocial health summary score||||0.005
72478315|NCT01090427|144482490|SUPERIORITY_OR_OTHER|||||||0.063|||||||ANOVA on van der Waerden normal Score|Treatment and baseline weight \[less than or equal to 60 kg vs greater than 60 kg\] were used as factors in the model.||PedsQL Psychosocial health summary score||||0.063
72478316|NCT01090427|144482490|SUPERIORITY_OR_OTHER|||||||0.007|||||||ANOVA on van der Waerden normal Score|Treatment and baseline weight \[less than or equal to 60 kg vs greater than 60 kg\] were used as factors in the model.||PedsQL Physical health summary score||||0.007
72478317|NCT01090427|144482490|SUPERIORITY_OR_OTHER|||||||0.02|||||||ANOVA on van der Waerden normal Score|Treatment and baseline weight \[less than or equal to 60 kg vs greater than 60 kg\] were used as factors in the model.||PedsQL Physical health summary score||||0.020
72478318|NCT01090427|144482491|SUPERIORITY_OR_OTHER|||||||0.027|||||||Cochran-Mantel-Haenszel|Stratified by body weight (less than or equal to 60 kg vs greater than 60 kg).||||||0.027
72478319|NCT01090427|144482491|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|Stratified by body weight (less than or equal to 60 kg vs greater than 60 kg).||||||<0.001
72478320|NCT01200589|144482492|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.15|||||TWO_SIDED|95.0|0.89|1.49||||||||1.49|0.89|
72478321|NCT01049217|144482506|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) Mean Difference|0.07|STANDARD_ERROR_OF_MEAN|0.191||0.709|TWO_SIDED|95.0|-0.3|0.45|||ANCOVA|||Analysis of covariance (ANCOVA) model was used with terms of treatment, pooled site, dideoxynucleoside analogue (D-drug) anti-retroviral agent (ART) use and baseline score.||0.45|-0.30|0.7090
72478322|NCT01049217|144482507|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5049|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Overall p-value was derived from Cochran-Mantel-Haenszel (CMH) test adjusted for pooled site and D-drug ART use using modified ridit scores.||||0.5049
72478323|NCT01049217|144482508|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4271|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Overall p-value was derived from Cochran-Mantel-Haenszel (CMH) test adjusted for pooled site and D-drug ART use using modified ridit scores.||||0.4271
72478324|NCT01049217|144482509|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.095||0.2084|TWO_SIDED|95.0|-0.31|0.07|||ANCOVA|||Change at Week 1: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.07|-0.31|0.2084
72478325|NCT01049217|144482509|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.126||0.1516|TWO_SIDED|95.0|-0.43|0.07|||ANCOVA|||Change at Week 2: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.07|-0.43|0.1516
72478326|NCT01049217|144482509|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.28|STANDARD_ERROR_OF_MEAN|0.142||0.0468|TWO_SIDED|95.0|-0.56|0.0|||ANCOVA|||Change at Week 3: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||-0.00|-0.56|0.0468
72478327|NCT01049217|144482509|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.27|STANDARD_ERROR_OF_MEAN|0.177||0.1224|TWO_SIDED|95.0|-0.62|0.07|||ANCOVA|||Change at Week 4: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.07|-0.62|0.1224
72478328|NCT01049217|144482509|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.39|STANDARD_ERROR_OF_MEAN|0.184||0.0373|TWO_SIDED|95.0|-0.75|-0.02|||ANCOVA|||Change at Week 5: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||-0.02|-0.75|0.0373
72478329|NCT01049217|144482509|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.28|STANDARD_ERROR_OF_MEAN|0.199||0.166|TWO_SIDED|95.0|-0.67|0.12|||ANCOVA|||Change at Week 6: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.12|-0.67|0.1660
72623397|NCT04191135|144777583|SUPERIORITY||Difference in Least Squares Means|4.82||||0.1597|TWO_SIDED|95.0|-1.97|11.62|||cLDA|cLDA model with PRO scores as the response variable with covariates for treatment by time interaction, stratification factors as covariates.||||11.62|-1.97|0.1597
72478330|NCT01049217|144482509|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.21|STANDARD_ERROR_OF_MEAN|0.214||0.3246|TWO_SIDED|95.0|-0.63|0.21|||ANCOVA|||Change at Week 7: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.21|-0.63|0.3246
72478331|NCT01049217|144482509|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.219||0.4879|TWO_SIDED|95.0|-0.58|0.28|||ANCOVA|||Change at Week 8: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.28|-0.58|0.4879
72478332|NCT01049217|144482509|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.25|STANDARD_ERROR_OF_MEAN|0.223||0.2669|TWO_SIDED|95.0|-0.69|0.19|||ANCOVA|||Change at Week 9: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.19|-0.69|0.2669
72478333|NCT01049217|144482509|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.219||0.5452|TWO_SIDED|95.0|-0.56|0.3|||ANCOVA|||Change at Week 10: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.30|-0.56|0.5452
72478334|NCT01049217|144482509|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.229||0.5469|TWO_SIDED|95.0|-0.59|0.31|||ANCOVA|||Change at Week 11: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.31|-0.59|0.5469
72478335|NCT01049217|144482509|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.24||0.7843|TWO_SIDED|95.0|-0.54|0.41|||ANCOVA|||Change at Week 12: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.41|-0.54|0.7843
72478336|NCT01049217|144482509|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.24||0.9008|TWO_SIDED|95.0|-0.5|0.44|||ANCOVA|||Change at Week 13: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.44|-0.50|0.9008
72478337|NCT01049217|144482509|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.03|STANDARD_ERROR_OF_MEAN|0.24||0.9064|TWO_SIDED|95.0|-0.45|0.5|||ANCOVA|||Change at Week 14: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.50|-0.45|0.9064
72478338|NCT01049217|144482509|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.243||0.7205|TWO_SIDED|95.0|-0.57|0.39|||ANCOVA|||Change at Week 15: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.39|-0.57|0.7205
72478339|NCT01049217|144482509|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.259||0.4334|TWO_SIDED|95.0|-0.71|0.31|||ANCOVA|||Change at Week 16: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.31|-0.71|0.4334
72478340|NCT01049217|144482509|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.199||0.8402|TWO_SIDED|95.0|-0.43|0.35|||ANCOVA|||Change at Endpoint: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.35|-0.43|0.8402
72478341|NCT01049217|144482510|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.085||0.3098|TWO_SIDED|95.0|-0.25|0.08|||ANCOVA|||Change at Week 1: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.08|-0.25|0.3098
72478342|NCT01049217|144482510|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.118||0.2429|TWO_SIDED|95.0|-0.37|0.09|||ANCOVA|||Change at Week 2: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.09|-0.37|0.2429
72508994|NCT01128972|144548336|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|4.11||||0.0083|TWO_SIDED|95.0|1.07|7.15||No adjustments made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment, study period, and subject (random effect).|Difference is first named treatment minus second named treatment such that a positive difference favours the first named treatment.|Null hypothesis considered population means for the test dentifrice+ test MR treatment regimen and test dentifrice + Sterile water rinse to be equal with respect to percent SMH recovery. Statistical tests were 2-sided with a significance level of 0.05.||7.15|1.07|0.0083
72478343|NCT01049217|144482510|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.27|STANDARD_ERROR_OF_MEAN|0.137||0.0504|TWO_SIDED|95.0|-0.54|0.0|||ANCOVA|||Change at Week 3: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.00|-0.54|0.0504
72478344|NCT01049217|144482510|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.26|STANDARD_ERROR_OF_MEAN|0.164||0.1141|TWO_SIDED|95.0|-0.58|0.06|||ANCOVA|||Change at Week 4: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.06|-0.58|0.1141
72478345|NCT01049217|144482510|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.32|STANDARD_ERROR_OF_MEAN|0.173||0.0667|TWO_SIDED|95.0|-0.66|0.02|||ANCOVA|||Change at Week 5: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.02|-0.66|0.0667
72478346|NCT01049217|144482510|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.24|STANDARD_ERROR_OF_MEAN|0.189||0.2104|TWO_SIDED|95.0|-0.61|0.13|||ANCOVA|||Change at Week 6: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.13|-0.61|0.2104
72508995|NCT01128972|144548336|SUPERIORITY_OR_OTHER||Adjusted Mean DIfference|11.25|||<|0.0001|TWO_SIDED|95.0|8.22|14.29||No adjustments made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment, study period, and subject (random effect)|Difference is first named treatment minus second named treatment such that a positive difference favours the first named treatment.|Null hypothesis considered population means for the test dentifrice+ test MR treatment regimen and reference dentifrice + Sterile water rinse treatment regimen to be equal with respect to percent SMH recovery. Statistical tests were 2-sided with a significance level of 0.05.||14.29|8.22|<0.0001
72623398|NCT04191135|144777584|SUPERIORITY||Difference in Least Squares Means|2.52||||0.6138|TWO_SIDED|95.0|-7.45|12.49|||cLDA|cLDA model with PRO scores as the response variable with covariates for treatment by time interaction, stratification factors as covariates.||||12.49|-7.45|0.6138
72478347|NCT01049217|144482510|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.197||0.483|TWO_SIDED|95.0|-0.53|0.25|||ANCOVA|||Change at Week 7: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.25|-0.53|0.4830
72478348|NCT01049217|144482510|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.203||0.5757|TWO_SIDED|95.0|-0.51|0.29|||ANCOVA|||Change at Week 8: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.29|-0.51|0.5757
72478349|NCT01049217|144482510|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.21|STANDARD_ERROR_OF_MEAN|0.208||0.3231|TWO_SIDED|95.0|-0.62|0.2|||ANCOVA|||Change at Week 9: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.20|-0.62|0.3231
72508996|NCT01128972|144548336|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|11.56|||<|0.0001|TWO_SIDED|95.0|8.53|14.6||No adjustments made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment, study period, and subject (random effect)|Difference is first named treatment minus second named treatment such that a positive difference favours the first named treatment.|Null hypothesis considered population means for the test dentifrice+ test MR treatment regimen and placebo dentifrice + Sterile water rinse treatment regimen to be equal with respect to percent SMH recovery. Statistical tests were 2-sided with a significance level of 0.05.||14.60|8.53|<0.0001
72508997|NCT01128972|144548337|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.88||||0.7041|TWO_SIDED|95.0|-5.46|3.69||No adjustments made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment, study period, and subject (random effect).|Difference is first named treatment minus second named treatment such that a positive difference favours the first named treatment.|Null hypothesis considered population means for the Placebo Dentifrice + Test MR and Test dentifrice+ Test MR treatment regimen treatment regimen to be equal with respect to percent NER. Statistical tests were 2-sided with a significance level of 0.05.||3.69|-5.46|0.7041
72478350|NCT01049217|144482510|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.21|STANDARD_ERROR_OF_MEAN|0.212||0.3143|TWO_SIDED|95.0|-0.63|0.2|||ANCOVA|||Change at Week 10: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.20|-0.63|0.3143
72478351|NCT01049217|144482510|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.222||0.63|TWO_SIDED|95.0|-0.54|0.33|||ANCOVA|||Change at Week 11: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.33|-0.54|0.6300
72478352|NCT01049217|144482510|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.227||0.5752|TWO_SIDED|95.0|-0.57|0.32|||ANCOVA|||Change at Week 12: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.32|-0.57|0.5752
72478353|NCT01049217|144482510|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.219||0.8905|TWO_SIDED|95.0|-0.46|0.4|||ANCOVA|||Change at Week 13: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.40|-0.46|0.8905
72478354|NCT01049217|144482510|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.228||0.9991|TWO_SIDED|95.0|-0.45|0.45|||ANCOVA|||Change at Week 14: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.45|-0.45|0.9991
72478355|NCT01049217|144482510|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.228||0.8927|TWO_SIDED|95.0|-0.48|0.42|||ANCOVA|||Change at Week 15: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.42|-0.48|0.8927
72623399|NCT04191135|144777585|SUPERIORITY||Difference in Least Squares Means|-1.6||||0.5567|TWO_SIDED|95.0|-7.02|3.83|||cLDA|cLDA model with PRO scores as the response variable with covariates for treatment by time interaction, stratification factors as covariates.||||3.83|-7.02|0.5567
72623400|NCT04191135|144777586|SUPERIORITY||Difference in Least Squares Means|5.56||||0.105|TWO_SIDED|95.0|-1.2|12.32|||cLDA|cLDA model with PRO scores as the response variable with covariates for treatment by time interaction, stratification factors as covariates.||||12.32|-1.20|0.1050
72508998|NCT01128972|144548337|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|10.78|||<|0.0001|TWO_SIDED|95.0|6.21|15.36||No adjustments made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment, study period, and subject (random effect).|Difference is first named treatment minus second named treatment such that a positive difference favours the first named treatment.|Null hypothesis considered population means for the Placebo dentifrice+ test MR treatment regimen and test dentifrice + sterile water rinse treatment regimen to be equal with respect to percent NER. Statistical tests were 2-sided with a significance level of 0.05.||15.36|6.21|<0.0001
72399944|NCT01729754|144307729|SUPERIORITY||Difference in percentages|7.0||||0.001|TWO_SIDED|95.0|2.8|11.6|||Cochran-Mantel-Haenszel|Stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.|Difference and CIs are calculated using Miettinen-Nurminen stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no) with sample size weights.|||11.6|2.8|0.001
72508999|NCT01128972|144548337|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|25.72|||<|0.0001|TWO_SIDED|95.0|21.14|30.29||No adjustments made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment, study period, and subject (random effect).|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered population means for the Placebo dentifrice+ Test MR treatment regimen and Reference dentifrice + sterile water rinse treatment regimen to be equal with respect to percent NER. Statistical tests were 2-sided with a significance level of 0.05.||30.29|21.14|<0.0001
72399945|NCT01729754|144307729|SUPERIORITY||Difference in percentages|7.6|||<|0.001|TWO_SIDED|95.0|3.3|12.3|||Cochran-Mantel-Haenszel|Stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.|Difference and CIs are calculated using Miettinen-Nurminen stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no) with sample size weights.|||12.3|3.3|<0.001
72509000|NCT01128972|144548337|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|36.29|||<|0.0001|TWO_SIDED|95.0|31.71|40.86||No adjustments made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment, study period, and subject (random effect).|Difference is first named treatment minus second named treatment such that a positive difference favours the first named treatment.|Null hypothesis considered population means for the Placebo dentifrice+ test MR treatment regimen and Placebo dentifrice + sterile water rinse treatment regimen to be equal with respect to percent NER. Statistical tests were 2-sided with a significance level of 0.05.||40.86|31.71|<0.0001
72566448|NCT02697773|144663274|SUPERIORITY||Least Square Mean Difference|-0.68|STANDARD_ERROR_OF_MEAN|0.22||0.0024|TWO_SIDED|95.0|-1.12|-0.24|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC average score and baseline diary average pain as covariates, and study site as a random effect.||-0.24|-1.12|0.0024
72566449|NCT02697773|144663274|SUPERIORITY||Least Square Mean Difference|-0.59|STANDARD_ERROR_OF_MEAN|0.22||0.0078|TWO_SIDED|95.0|-1.03|-0.16|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC average score and baseline diary average pain as covariates, and study site as a random effect.||-0.16|-1.03|0.0078
72566450|NCT02697773|144663274|SUPERIORITY||Least Square Mean Difference|-0.89|STANDARD_ERROR_OF_MEAN|0.24||0.0002|TWO_SIDED|95.0|-1.35|-0.43|||ANCOVA|||Week 12: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC average score and baseline diary average pain as covariates, and study site as a random effect.||-0.43|-1.35|0.0002
72478356|NCT01049217|144482510|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.245||0.8067|TWO_SIDED|95.0|-0.54|0.42|||ANCOVA|||Change at Week 16: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.42|-0.54|0.8067
72478357|NCT01049217|144482510|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.02|STANDARD_ERROR_OF_MEAN|0.19||0.9009|TWO_SIDED|95.0|-0.35|0.4|||ANCOVA|||Change at Endpoint: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.40|-0.35|0.9009
72478358|NCT01049217|144482511|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.177||0.0948|TWO_SIDED|95.0|-0.64|0.05|||ANCOVA|||Change at Week 4, PSI: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.05|-0.64|0.0948
72478359|NCT01049217|144482511|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.203||0.4167|TWO_SIDED|95.0|-0.57|0.23|||ANCOVA|||Change at Week 8, PSI: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.23|-0.57|0.4167
72478360|NCT01049217|144482511|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.05|STANDARD_ERROR_OF_MEAN|0.226||0.8179|TWO_SIDED|95.0|-0.39|0.5|||ANCOVA|||Change at Week 12, PSI: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.50|-0.39|0.8179
72478361|NCT01049217|144482511|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.08|STANDARD_ERROR_OF_MEAN|0.209||0.6913|TWO_SIDED|95.0|-0.33|0.5|||ANCOVA|||Change at Week 16, PSI: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.50|-0.33|0.6913
72478362|NCT01049217|144482511|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.203||0.9475|TWO_SIDED|95.0|-0.39|0.41|||ANCOVA|||Change at Endpoint, PSI: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.41|-0.39|0.9475
72478363|NCT01049217|144482511|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.204||0.7412|TWO_SIDED|95.0|-0.47|0.33|||ANCOVA|||Change at Week 4, PII: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.33|-0.47|0.7412
72478364|NCT01049217|144482511|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.213||0.9715|TWO_SIDED|95.0|-0.41|0.43|||ANCOVA|||Change at Week 8, PII: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.43|-0.41|0.9715
72399946|NCT01729754|144307730|SUPERIORITY||Difference in percentages|15.7|||<|0.001|TWO_SIDED|95.0|9.4|22.1|||Cochran-Mantel-Haenszel|Stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.|Difference and CIs are calculated using Miettinen-Nurminen stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no) with sample size weights.|||22.1|9.4|<0.001
72399947|NCT01729754|144307730|SUPERIORITY||Difference in percentages|11.7|||<|0.001|TWO_SIDED|95.0|5.6|17.9|||Cochran-Mantel-Haenszel|Stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.|Difference and CIs are calculated using Miettinen-Nurminen stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no) with sample size weights.|||17.9|5.6|<0.001
72399948|NCT01729754|144307734|OTHER||Difference in least squares means|-8.2|||<|0.001|TWO_SIDED|95.0|-9.3|-7.2|||cLDA|Terms for time, the interaction of time by treatment, body weight (\<=90 kg, \>90 kg), and prior exposure to biologic therapy for psoriasis (yes/no).||||-7.2|-9.3|<0.001
72399949|NCT01729754|144307734|OTHER||Difference in least squares means|-8.3|||<|0.001|TWO_SIDED|95.0|-9.3|-7.3|||cLDA|Terms for time, the interaction of time by treatment, body weight (\<=90 kg, \>90 kg), and prior exposure to biologic therapy for psoriasis (yes/no).||||-7.3|-9.3|<0.001
72399950|NCT01729754|144307734|OTHER||Difference in least squares means|-1.3||||0.002|TWO_SIDED|95.0|-2.1|-0.5|||cLDA|Terms for time, the interaction of time by treatment, body weight (\<=90 kg, \>90 kg), and prior exposure to biologic therapy for psoriasis (yes/no).||||-0.5|-2.1|0.002
72399951|NCT01729754|144307734|OTHER||Difference in least squares means|-1.4||||0.001|TWO_SIDED|95.0|-2.2|-0.6|||cLDA|Terms for time, the interaction of time by treatment, body weight (\<=90 kg, \>90 kg), and prior exposure to biologic therapy for psoriasis (yes/no).||||-0.6|-2.2|0.001
72399952|NCT01729754|144307735|OTHER||Difference in least squares means|-1.7|||<|0.001|TWO_SIDED|95.0|-2.4|-1.0|||cLDA|Terms for time, the interaction of time by treatment, body weight (\<=90 kg, \>90 kg), and prior exposure to biologic therapy for psoriasis (yes/no).||||-1.0|-2.4|<0.001
72399953|NCT01729754|144307735|OTHER||Difference in least squares means|-2.2|||<|0.001|TWO_SIDED|95.0|-2.9|-1.5|||cLDA|Terms for time, the interaction of time by treatment, body weight (\<=90 kg, \>90 kg), and prior exposure to biologic therapy for psoriasis (yes/no).||||-1.5|-2.9|<0.001
72399954|NCT01729754|144307738|OTHER||Difference in percentages|39.3|||<|0.001|TWO_SIDED|95.0|31.8|46.1|||Cochran-Mantel-Haenszel|Stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.|Difference and CIs are calculated using Miettinen-Nurminen stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no) with sample size weights.|||46.1|31.8|<0.001
72399955|NCT01729754|144307738|OTHER||Difference in percentages|32.1|||<|0.001|TWO_SIDED|95.0|24.5|39.1|||Cochran-Mantel-Haenszel|Stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.|Difference and CIs are calculated using Miettinen-Nurminen stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no) with sample size weights.|||39.1|24.5|<0.001
72399956|NCT01729754|144307738|OTHER||Difference in percentages|11.9||||0.003|TWO_SIDED|95.0|4.1|19.5|||Cochran-Mantel-Haenszel|Stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.|Difference and CIs are calculated using Miettinen-Nurminen stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no) with sample size weights.|||19.5|4.1|0.003
72399957|NCT01729754|144307738|OTHER||Difference in percentages|4.8||||0.221|TWO_SIDED|95.0|-2.9|12.5|||Cochran-Mantel-Haenszel|Stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.|Difference and CIs are calculated using Miettinen-Nurminen stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no) with sample size weights.|||12.5|-2.9|0.221
72399958|NCT01729754|144307739|OTHER||Difference in percentages|25.7|||<|0.001|TWO_SIDED|95.0|17.7|33.4|||Cochran-Mantel-Haenszel|Stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.|Difference and CIs are calculated using Miettinen-Nurminen stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no) with sample size weights.|||33.4|17.7|<0.001
72399959|NCT01729754|144307739|OTHER||Difference in percentages|15.0|||<|0.001|TWO_SIDED|95.0|6.9|22.9|||Cochran-Mantel-Haenszel|Stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.|Difference and CIs are calculated using Miettinen-Nurminen stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no) with sample size weights.|||22.9|6.9|<0.001
72399960|NCT00773292|144307749|OTHER|change from baseline||||||0.24|||||||t-test, 2 sided|||||||0.24
72399961|NCT00112502|144307756|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.2|||||TWO_SIDED|95.0|0.8|1.7||||||||1.7|0.8|
72399962|NCT00112502|144307757|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.8|||||TWO_SIDED|95.0|0.6|1.2||||||||1.2|0.6|
72399963|NCT00112502|144307758|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.3|||||TWO_SIDED|95.0|0.9|1.8||||||||1.8|0.9|
72623401|NCT04191135|144777587|SUPERIORITY||Hazard Ratio (HR)|1.78||||0.00676|TWO_SIDED|95.0|1.16|2.71|||Log Rank|Stratified log-rank test|Estimate via stratified Cox model with Efron's handling method with treatment as a covariate stratified by response to the induction therapy (CR/PR versus SD), tumor PD-L1 status (CPS ≥1 vs CPS \<1) and BRCA Status (BRCAm versus wild type BRCA gene).|||2.71|1.16|0.00676
72623402|NCT04191135|144777588|SUPERIORITY||Hazard Ratio (HR)|1.01||||0.96425|TWO_SIDED|95.0|0.61|1.69|||Log Rank|Stratified log-rank test|Estimate via stratified Cox model with Efron's handling method with treatment as a covariate stratified by response to the induction therapy (CR/PR versus SD), tumor PD-L1 status (CPS ≥1 vs CPS \<1) and BRCA Status (BRCAm versus wild type BRCA gene).|||1.69|0.61|0.96425
72399964|NCT00112502|144307759|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.9|||||TWO_SIDED|95.0|0.6|1.3||||||||1.3|0.6|
72399965|NCT00112502|144307761|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.0|||||TWO_SIDED|95.0|0.7|1.5||||||||1.5|0.7|
72399966|NCT00112502|144307762|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.8|||||TWO_SIDED|95.0|0.5|1.2||||||||1.2|0.5|
72478365|NCT01049217|144482511|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.05|STANDARD_ERROR_OF_MEAN|0.218||0.8163|TWO_SIDED|95.0|-0.38|0.48|||ANCOVA|||Change at Week 12, PII: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.48|-0.38|0.8163
72478366|NCT01049217|144482511|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.18|STANDARD_ERROR_OF_MEAN|0.204||0.3682|TWO_SIDED|95.0|-0.22|0.58|||ANCOVA|||Change at Week 16, PII: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.58|-0.22|0.3682
72478367|NCT01049217|144482511|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.19|STANDARD_ERROR_OF_MEAN|0.199||0.3511|TWO_SIDED|95.0|-0.21|0.58|||ANCOVA|||Change at Endpoint, PII: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.58|-0.21|0.3511
72478368|NCT01049217|144482512|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.25||0.9686|TWO_SIDED|95.0|-0.5|0.5|||ANCOVA|||Change at Endpoint, Burning: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.5|-0.5|0.9686
72478369|NCT01049217|144482512|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.23||0.4476|TWO_SIDED|95.0|-0.6|0.3|||ANCOVA|||Change at Endpoint, Squeezing: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.3|-0.6|0.4476
72478370|NCT01049217|144482512|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.24||0.563|TWO_SIDED|95.0|-0.6|0.3|||ANCOVA|||Change at Endpoint, Pressure: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.3|-0.6|0.5630
72478371|NCT01049217|144482512|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.25||0.9937|TWO_SIDED|95.0|-0.5|0.5|||ANCOVA|||Change at Endpoint, Electric Shocks: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.5|-0.5|0.9937
72478372|NCT01049217|144482512|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.25||0.8718|TWO_SIDED|95.0|-0.5|0.5|||ANCOVA|||Change at Endpoint, Stabbing: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.5|-0.5|0.8718
72478373|NCT01049217|144482512|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.24||0.8241|TWO_SIDED|95.0|-0.5|0.4|||ANCOVA|||Change at Endpoint, Light Touching: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.4|-0.5|0.8241
72478374|NCT01049217|144482512|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.25||0.3164|TWO_SIDED|95.0|-0.7|0.2|||ANCOVA|||Change at Endpoint, Pressure of Area: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.2|-0.7|0.3164
72478375|NCT01049217|144482512|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.25||0.8996|TWO_SIDED|95.0|-0.5|0.5|||ANCOVA|||Change at Endpoint, Cold of Area: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.5|-0.5|0.8996
72566451|NCT02697773|144663274|SUPERIORITY||Least Square Mean Difference|-1.04|STANDARD_ERROR_OF_MEAN|0.24|<|0.0001|TWO_SIDED|95.0|-1.5|-0.57|||ANCOVA|||Week 12: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC average score and baseline diary average pain as covariates, and study site as a random effect.||-0.57|-1.50|<.0001
72623403|NCT04191135|144777589|SUPERIORITY||Hazard Ratio (HR)|1.08||||0.74965|TWO_SIDED|95.0|0.69|1.71|||Log Rank|Stratified log-rank test|Estimate via stratified Cox model with Efron's handling method with treatment as a covariate stratified by response to the induction therapy (CR/PR versus SD), tumor PD-L1 status (CPS ≥1 vs CPS \<1) and BRCA Status (BRCAm versus wild type BRCA gene).|||1.71|0.69|0.74965
72478376|NCT01049217|144482512|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.26||0.9676|TWO_SIDED|95.0|-0.5|0.5|||ANCOVA|||Change at Endpoint, Pins and Needles: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.5|-0.5|0.9676
72478377|NCT01049217|144482512|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.25||0.9091|TWO_SIDED|95.0|-0.5|0.5|||ANCOVA|||Change at Endpoint, Tingling: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.5|-0.5|0.9091
72478378|NCT01049217|144482513|SUPERIORITY_OR_OTHER_LEGACY|||||||0.73|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Duration of Spontaneous Pain: Overall p-value was derived from CMH test adjusted for pooled site and D-drug ART use using modified ridit scores.||||0.7300
72478379|NCT01049217|144482513|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0559|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Number of Pain Attacks: Overall p-value was derived from CMH test adjusted for pooled site and D-drug ART use using modified ridit scores.||||0.0559
72478380|NCT01049217|144482514|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.025||0.9686|TWO_SIDED|95.0|-0.05|0.05|||ANCOVA|||Change at Endpoint, Burning Pain: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.05|-0.05|0.9686
72478381|NCT01049217|144482514|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.022||0.4711|TWO_SIDED|95.0|-0.06|0.03|||ANCOVA|||Change at Endpoint, Pressing Pain: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.03|-0.06|0.4711
72478382|NCT01049217|144482514|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.023||0.9215|TWO_SIDED|95.0|-0.04|0.05|||ANCOVA|||Change at Endpoint, Paroxysmal Pain: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.05|-0.04|0.9215
72478383|NCT01049217|144482514|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.021||0.6042|TWO_SIDED|95.0|-0.05|0.03|||ANCOVA|||Change at Endpoint, Evoked Pain: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.03|-0.05|0.6042
72478384|NCT01049217|144482514|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.024||0.9394|TWO_SIDED|95.0|-0.05|0.04|||ANCOVA|||Change at Endpoint, P/D: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.04|-0.05|0.9394
72478385|NCT01049217|144482514|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.02||0.7801|TWO_SIDED|95.0|-0.04|0.03|||ANCOVA|||Change at Endpoint, Total Score: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.03|-0.04|0.7801
72566452|NCT02697773|144663274|SUPERIORITY||Least Square Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.24||0.0034|TWO_SIDED|95.0|-1.16|-0.23|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC average score and baseline diary average pain as covariates, and study site as a random effect.||-0.23|-1.16|0.0034
72566453|NCT02697773|144663274|SUPERIORITY||Least Square Mean Difference|-0.87|STANDARD_ERROR_OF_MEAN|0.24||0.0003|TWO_SIDED|95.0|-1.33|-0.4|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC average score and baseline diary average pain as covariates, and study site as a random effect.||-0.40|-1.33|0.0003
72566454|NCT02697773|144663276|SUPERIORITY||Least Square Mean Difference|-0.66|STANDARD_ERROR_OF_MEAN|0.22||0.0026|TWO_SIDED|95.0|-1.1|-0.23|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects,baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.||-0.23|-1.10|0.0026
72566455|NCT02697773|144663276|SUPERIORITY||Least Mean Square Difference|-0.67|STANDARD_ERROR_OF_MEAN|0.22||0.0023|TWO_SIDED|95.0|-1.1|-0.24|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects,baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.||-0.24|-1.10|0.0023
72566456|NCT02697773|144663276|SUPERIORITY||Least Square Mean Difference|-0.85|STANDARD_ERROR_OF_MEAN|0.23||0.0002|TWO_SIDED|95.0|-1.29|-0.4|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects,baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.||-0.40|-1.29|0.0002
72566457|NCT02697773|144663276|SUPERIORITY||Least Square Mean Difference|-0.91|STANDARD_ERROR_OF_MEAN|0.22|<|0.0001|TWO_SIDED|95.0|-1.35|-0.47|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects,baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.||-0.47|-1.35|<.0001
72566458|NCT02697773|144663276|SUPERIORITY||Least Square Mean Difference|-0.64|STANDARD_ERROR_OF_MEAN|0.24||0.0066|TWO_SIDED|95.0|-1.11|-0.18|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects,baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.||-0.18|-1.11|0.0066
72566459|NCT02697773|144663276|SUPERIORITY||Least Square Mean Difference|-0.34|STANDARD_ERROR_OF_MEAN|0.23||0.1506|TWO_SIDED|95.0|-0.79|0.12|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects,baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.||0.12|-0.79|0.1506
72399967|NCT00112502|144307763|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.2|||||TWO_SIDED|95.0|0.8|1.8||||||||1.8|0.8|
72478386|NCT01049217|144482515|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-3.44|STANDARD_ERROR_OF_MEAN|6.58||0.6012|TWO_SIDED||||||ANCOVA|||Endpoint TST: ANCOVA model was used with treatment as a fixed effect and D-drug ART, pooled site value, baseline value as covariates.||||0.6012
72566460|NCT02697773|144663276|SUPERIORITY||Least Square Mean Difference|-0.76|STANDARD_ERROR_OF_MEAN|0.25||0.0021|TWO_SIDED|95.0|-1.25|-0.28|||ANCOVA|||Week 12: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects,baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.||-0.28|-1.25|0.0021
72566461|NCT02697773|144663276|SUPERIORITY||Least Square Mean Difference|-0.83|STANDARD_ERROR_OF_MEAN|0.25||0.0008|TWO_SIDED|95.0|-1.32|-0.35|||ANCOVA|||Week 12: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects,baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.||-0.35|-1.32|0.0008
72623404|NCT04191135|144777590|SUPERIORITY||Hazard Ratio (HR)|1.76||||0.10502|TWO_SIDED|95.0|0.88|3.53|||Log Rank|Stratified log-rank test|Estimate via stratified Cox model with Efron's handling method with treatment as a covariate stratified by response to the induction therapy (CR/PR versus SD), tumor PD-L1 status (CPS ≥1 vs CPS \<1) and BRCA Status (BRCAm versus wild type BRCA gene).|||3.53|0.88|0.10502
72399968|NCT00112502|144307764|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.7|||||TWO_SIDED|95.0|0.5|1.1||||||||1.1|0.5|
72478387|NCT01049217|144482515|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-3.66|STANDARD_ERROR_OF_MEAN|1.89||0.0534|TWO_SIDED||||||ANCOVA|||Endpoint MIS: ANCOVA model was used with treatment as a fixed effect and D-drug ART, pooled site value, baseline value as covariates.||||0.0534
72478388|NCT01049217|144482516|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.03|STANDARD_ERROR_OF_MEAN|0.62||0.0966|TWO_SIDED||||||ANCOVA|||ANCOVA model was used with treatment as a fixed effect and D-drug ART, pooled site value, baseline value as covariates.||||0.0966
72399969|NCT00870363|144307766|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Kruskal-Wallis|||||||>0.05
72399970|NCT01959542|144307779|OTHER|Pearson's product-moment correlation|Pearson's product-moment correlation|-0.53||||0.09|TWO_SIDED|95.0|-86.0|0.1|||Pearson's product-moment correlation|||||0.10|-086|0.09
72399971|NCT01959542|144307780|OTHER||Pearson's product-moment correlation|-0.62||||0.03|TWO_SIDED|95.0|-0.62|-0.15|||Pearson's product-moment correlation|Pearson's product moment correlation||||-0.15|-0.62|0.03
72399972|NCT03388138|144307802|NON_INFERIORITY|Non-inferiority of the etafilcon A with ketotifen lens relative to the etafilcon A lens was established if the upper limit of the 95% confidence interval was below 0.1 logMAR.|Least-Square Mean Difference|0.0017|STANDARD_ERROR_OF_MEAN|0.01169|||TWO_SIDED|95.0|-0.021|0.025|||Linear Mixed Model|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.|LS Mean difference was calculated as etafilcon A with ketotifen - etafilcon A|||0.025|-0.021|
72478389|NCT01049217|144482517|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.97|STANDARD_ERROR_OF_MEAN|0.51||0.0611|TWO_SIDED||||||ANCOVA|||ANCOVA model was used with treatment as a fixed effect and D-drug ART, pooled site value, baseline value as covariates.||||0.0611
72478390|NCT01049217|144482518|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-8436.0|STANDARD_ERROR_OF_MEAN|6855.2||0.2195|TWO_SIDED||||||ANCOVA|||ANCOVA model was used with treatment as a fixed effect and D-drug ART, pooled site value, baseline value as covariates.||||0.2195
72478391|NCT01049217|144482519|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|ANCOVA model was used with treatment as a fixed effect and D-drug ART, pooled site value, baseline value as covariates.|LS Mean Difference|0.15|STANDARD_ERROR_OF_MEAN|0.66||0.8241|TWO_SIDED||||||ANCOVA|||||||0.8241
72478392|NCT01049217|144482520|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.38|STANDARD_ERROR_OF_MEAN|2.052||0.8528|TWO_SIDED|95.0|-4.42|3.66|||ANCOVA|||Change at Endpoint, Sleep Disturbance: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||3.66|-4.42|0.8528
72509001|NCT01128972|144548338|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-4.39||||0.0049|TWO_SIDED|95.0|-7.43|-1.35||No adjustments made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment, study period, and subject (random effect).|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment|Null hypothesis considered population means for the Placebo dentifrice+ Test MR treatment regimen and Test dentifrice + Test MR to be equal with respect to percent SMH recovery. Statistical tests were 2-sided with a significance level of 0.05.||-1.35|-7.43|0.0049
72509002|NCT01128972|144548338|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.28||||0.8571|TWO_SIDED|95.0|-3.31|2.76||No adjustments made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment, study period, and subject (random effect).|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered population means for the Placebo dentifrice+ test MR treatment regimen and test dentifrice + sterile water rinse to be equal with respect to percent SMH recovery. Statistical tests were 2-sided with a significance level of 0.05.||2.76|-3.31|0.8571
72566462|NCT02697773|144663276|SUPERIORITY||Least Square Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.25||0.0167|TWO_SIDED|95.0|-1.09|-0.11|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects,baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.||-0.11|-1.09|0.0167
72623405|NCT04191135|144777591|SUPERIORITY||Hazard Ratio (HR)|1.31||||0.5019|TWO_SIDED|95.0|0.57|3.0|||Log Rank|Stratified log-rank test|Estimate via stratified Cox model with Efron's handling method with treatment as a covariate stratified by response to the induction therapy (CR/PR versus SD), and tumor PD-L1 status (CPS ≥1 vs CPS \<1).|||3.00|0.57|0.50190
72623406|NCT04191135|144777592|SUPERIORITY||Hazard Ratio (HR)|0.68||||0.47384|TWO_SIDED|95.0|0.24|1.97|||Log Rank|Stratified log-rank test|Estimate via stratified Cox model with Efron's handling method with treatment as a covariate stratified by response to the induction therapy (CR/PR versus SD), and tumor PD-L1 status (CPS ≥1 vs CPS \<1).|||1.97|0.24|0.47384
72399973|NCT03388138|144307803|NON_INFERIORITY|Non-inferiority of the etafilcon A with ketotifen lens relative to the etafilcon A lens was established if the upper limit of the 95% confidence interval was below 0.1 logMAR.|Least-Square Mean Difference|0.0007|STANDARD_ERROR_OF_MEAN|0.01158|||TWO_SIDED|95.0|-0.022|0.024|||Linear Mixed Model|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.|LS Mean difference was calculated as etafilcon A with ketotifen - etafilcon A|||0.024|-0.022|
72399974|NCT01268111|144307806|SUPERIORITY_OR_OTHER|||||||0.4||95.0|||||t-test, 2 sided|||||||0.4
72399975|NCT03329690|144307813|SUPERIORITY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|CMH test with region as a stratification factor||||||<0.0001
72399976|NCT02418468|144307831|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1|STANDARD_ERROR_OF_MEAN|0.08||0.262|TWO_SIDED|95.0|-0.26|0.07|||mixed models for repeated measures (MMRM|||||0.07|-0.26|0.262
72399977|NCT02337907|144307832|SUPERIORITY|H0: The dose group with the peak response in the respective model Mean NTB response = Mean NTB response of placebo.|Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.073||0.7907|TWO_SIDED|95.0|-0.163|0.124||p-value was nominal and not adjusted.|Mixed Model Repeated Measurement (MMRM)|Kenward-Roger was used to model degrees of freedom.|The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|Mixed Model Repeated Measurement (MMRM) includes fixed, categorical effects of treatment, visit, current Acetylcholine Esterase Inhibitor (AChEI) use (Yes, No), and treatment-by-visit interaction, as well as the continuous fixed covariates of baseline, and baseline-by-visit interaction.||0.124|-0.163|0.7907
72478393|NCT01049217|144482520|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|2.88|STANDARD_ERROR_OF_MEAN|3.179||0.365|TWO_SIDED|95.0|-3.37|9.14|||ANCOVA|||Change at Endpoint, Snoring: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||9.14|-3.37|0.3650
72478394|NCT01049217|144482520|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.89|STANDARD_ERROR_OF_MEAN|2.525||0.7237|TWO_SIDED|95.0|-4.07|5.86|||ANCOVA|||Change at Endpoint, SOB: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||5.86|-4.07|0.7237
72478395|NCT01049217|144482520|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.165||0.2783|TWO_SIDED|95.0|-0.5|0.15|||ANCOVA|||Change at Endpoint, Quantity: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.15|-0.50|0.2783
72478396|NCT01049217|144482520|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|3.02|STANDARD_ERROR_OF_MEAN|2.611||0.2475|TWO_SIDED|95.0|-2.11|8.16|||ANCOVA|||Change at Endpoint, Adequacy: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||8.16|-2.11|0.2475
72399978|NCT02337907|144307832|SUPERIORITY|H0: The dose group with the peak response in the respective model Mean NTB response = Mean NTB response of placebo.|Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.075||0.7622|TWO_SIDED|95.0|-0.125|0.171||p-value was nominal and not adjusted.|Mixed Model Repeated Measurement (MMRM)|Kenward-Roger was used to model degrees of freedom.|The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|Mixed Model Repeated Measurement (MMRM) includes fixed, categorical effects of treatment, visit, current Acetylcholine Esterase Inhibitor (AChEI) use (Yes, No), and treatment-by-visit interaction, as well as the continuous fixed covariates of baseline, and baseline-by-visit interaction.||0.171|-0.125|0.7622
72478397|NCT01049217|144482520|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|1.16|STANDARD_ERROR_OF_MEAN|1.933||0.5492|TWO_SIDED|95.0|-2.64|4.96|||ANCOVA|||Change at Endpoint, Somnolence: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||4.96|-2.64|0.5492
72478398|NCT01049217|144482520|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.18|STANDARD_ERROR_OF_MEAN|1.614||0.9113|TWO_SIDED|95.0|-3.0|3.36|||ANCOVA|||Change at Endpoint, Sleep Problems Index: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||3.36|-3.00|0.9113
72478399|NCT01049217|144482521|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7399|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Endpoint: Overall p-value was derived from CMH test adjusted for pooled site and D-drug ART use using modified ridit scores.||||0.7399
72478400|NCT01049217|144482522|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.08|STANDARD_ERROR_OF_MEAN|0.386||0.8258|TWO_SIDED|95.0|-0.67|0.84|||ANCOVA|||Change at Endpoint, HADS-A: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.84|-0.67|0.8258
72478401|NCT01049217|144482522|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.65|STANDARD_ERROR_OF_MEAN|0.372||0.084|TWO_SIDED|95.0|-0.09|1.38|||ANCOVA|||Change at Endpoint, HADS-D: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||1.38|-0.09|0.0840
72478402|NCT01049217|144482523|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|1.22|STANDARD_ERROR_OF_MEAN|2.393||0.6114|TWO_SIDED|95.0|-3.49|5.92|||ANCOVA|||Change at Endpoint, Ph Fn: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||5.92|-3.49|0.6114
72478403|NCT01049217|144482523|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.57|STANDARD_ERROR_OF_MEAN|2.522||0.8209|TWO_SIDED|95.0|-4.39|5.53|||ANCOVA|||Change at Endpoint, R-P: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||5.53|-4.39|0.8209
72478404|NCT01049217|144482523|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.08|STANDARD_ERROR_OF_MEAN|2.335||0.9737|TWO_SIDED|95.0|-4.52|4.67|||ANCOVA|||Change at Endpoint, BP: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||4.67|-4.52|0.9737
72509003|NCT01128972|144548338|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|6.87|||<|0.0001|TWO_SIDED|95.0|3.83|9.9||No adjustments made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment, study period, and subject (random effect).|Difference is first named treatment minus second named treatment such that a positive difference favours the first named treatment.|Null hypothesis considered population means for the Placebo Dentifrice + Test MR treatment regimen and Reference Dentifrice + Sterile water rinse to be equal with respect to percent SMH recovery. Statistical tests were 2-sided with a significance level of 0.05.||9.90|3.83|<0.0001
72509004|NCT01128972|144548338|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|7.17|||<|0.0001|TWO_SIDED|95.0|4.14|10.21||No adjustments made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment, study period, and subject (random effect).|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered population means for the Placebo Dentifrice + Test MR treatment regimen and Placebo dentifrice + Sterile water rinse to be equal with respect to percent SMH recovery. Statistical tests were 2-sided with a significance level of 0.05.||10.21|4.14|<0.0001
72566463|NCT02697773|144663276|SUPERIORITY||Least Square Mean Difference|-0.68|STANDARD_ERROR_OF_MEAN|0.25||0.0073|TWO_SIDED|95.0|-1.17|-0.18|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects,baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.||-0.18|-1.17|0.0073
72478405|NCT01049217|144482523|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.76|STANDARD_ERROR_OF_MEAN|1.937||0.6966|TWO_SIDED|95.0|-3.05|4.57|||ANCOVA|||Change at Endpoint, GH: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||4.57|-3.05|0.6966
72478406|NCT01049217|144482523|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.15|STANDARD_ERROR_OF_MEAN|0.807||0.8569|TWO_SIDED|95.0|-1.44|1.73|||ANCOVA|||Change at Endpoint, Ph C: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||1.73|-1.44|0.8569
72478407|NCT01049217|144482523|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.33|STANDARD_ERROR_OF_MEAN|1.847||0.4734|TWO_SIDED|95.0|-4.96|2.31|||ANCOVA|||Change at Endpoint, Vit: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||2.31|-4.96|0.4734
72478408|NCT01049217|144482523|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.97|STANDARD_ERROR_OF_MEAN|2.159||0.3625|TWO_SIDED|95.0|-6.22|2.28|||ANCOVA|||Change at Endpoint, So Fn: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||2.28|-6.22|0.3625
72478409|NCT01049217|144482523|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|2.79|STANDARD_ERROR_OF_MEAN|2.543||0.2736|TWO_SIDED|95.0|-2.21|7.79|||ANCOVA|||Change at Endpoint, R-E: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||7.79|-2.21|0.2736
72478410|NCT01049217|144482523|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.41|STANDARD_ERROR_OF_MEAN|1.811||0.8199|TWO_SIDED|95.0|-3.98|3.15|||ANCOVA|||Change at Endpoint, MnH: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||3.15|-3.98|0.8199
72478411|NCT01049217|144482523|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.08|STANDARD_ERROR_OF_MEAN|0.967||0.9361|TWO_SIDED|95.0|-1.82|1.98|||ANCOVA|||Change at Endpoint, Mn C: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||1.98|-1.82|0.9361
72478412|NCT00903682|144482539|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Regression, Logistic|||The hypothesis is that the proportion of patients with at least 1 treatment-emergent Grade 1-4 neuropsychiatric adverse event, observed between Baseline through Week 12 and judged to be at least possibly drug-related, is significantly lower in the ETR arm than in the EFV arm. Assuming a significance level of 5%, a sample size of 75 subjects per arm would provide over 90% power to detect a 29% difference in treatment-emergent, drug-related Grade 1-4 neuropsychiatric adverse events.||||<0.001
72478413|NCT00903682|144482540|SUPERIORITY_OR_OTHER||Difference in proportion of response|1.61|||||TWO_SIDED|95.0|-12.0|15.23|||||Difference in proportion of response ETR minus EFV|||15.23|-12.00|
72478414|NCT02495792|144482548|OTHER||Risk Ratio (RR)|5.98|||||TWO_SIDED|95.0|1.6|21.7||||||||21.7|1.6|
72478415|NCT00686725|144482558|SUPERIORITY_OR_OTHER|||||||0.183||95.0|||||Log Rank|||||||0.183
72478416|NCT00686725|144482559|SUPERIORITY_OR_OTHER|||||||0.35||95.0|||||Log Rank|||||||0.35
72478417|NCT00686725|144482562|SUPERIORITY_OR_OTHER|||||||0.648||95.0|||||Log Rank|||||||0.648
72478418|NCT00686725|144482563|SUPERIORITY_OR_OTHER|||||||0.915||95.0|||||Log Rank|||||||0.915
72478419|NCT00955253|144482603|SUPERIORITY|||||||0.013|||||||t-test, 2 sided|||between the placebo and guanfacine conditions||||0.013
72623407|NCT04191135|144777593|SUPERIORITY||Hazard Ratio (HR)|0.88||||0.81463|TWO_SIDED|95.0|0.33|2.38|||Log Rank|Stratified log-rank test|Estimate via stratified Cox model with Efron's handling method with treatment as a covariate stratified by response to the induction therapy (CR/PR versus SD), and tumor PD-L1 status (CPS ≥1 vs CPS \<1).|||2.38|0.33|0.81463
72509005|NCT01128972|144548339|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|14.94|||||TWO_SIDED|95.0|10.36|19.51||No adjustments made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment, study period, and subject (random effect).|Difference is first named treatment minus second named treatment such that a positive difference favours the first named treatment.|Null hypothesis considered population means for the Test Dentifrice + Sterile water rinse treatment regimen andReference Dentifrice + Sterile water rinse treatment regimen to be equal with respect to percent NER. Statistical tests were 2-sided with a significance level of 0.05.||19.51|10.36|
72623408|NCT04191135|144777594|SUPERIORITY||Hazard Ratio (HR)|1.47||||0.67255|TWO_SIDED|95.0|0.24|8.82|||Log Rank|Stratified log-rank test|Estimate via stratified Cox model with Efron's handling method with treatment as a covariate stratified by response to the induction therapy (CR/PR versus SD), and tumor PD-L1 status (CPS ≥1 vs CPS \<1).|||8.82|0.24|0.67255
72478420|NCT00558259|144482605|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.08|STANDARD_ERROR_OF_MEAN|0.05|<|0.0001||95.0|0.02|0.25|||Regression, Cox|||Dabigatran vs placebo||0.25|0.02|<0.0001
72478421|NCT00558259|144482606|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.08|STANDARD_ERROR_OF_MEAN|0.05|<|0.0001||95.0|0.03|0.27|||Regression, Cox|||Dabigatran vs placebo||0.27|0.03|<0.0001
72478422|NCT00558259|144482607|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Fisher Exact|||||||< 0.0001
72478423|NCT00558259|144482607|SUPERIORITY_OR_OTHER||Percentage of participants with events|0.3|||||TWO_SIDED|95.0|0.04|1.06|||||The confidence interval (Clopper-Pearson method) was calculated for the percentage of participants experiencing DVT in Dabigatran group.|||1.06|0.04|
72478424|NCT00558259|144482607|SUPERIORITY_OR_OTHER||Percentage of participants with events|3.5|||||TWO_SIDED|95.0|2.21|5.17|||||The confidence interval (Clopper-Pearson method) was calculated for the percentage of participants experiencing DVT in placebo group.|||5.17|2.21|
72478425|NCT00558259|144482608|SUPERIORITY_OR_OTHER|||||||0.0004|||||||Fisher Exact|||Dabigatran vs. Placebo||||0.0004
72478426|NCT00558259|144482608|SUPERIORITY_OR_OTHER||Percentage of participants with events|0.1|||||TWO_SIDED|95.0|0.0|0.82|||||The confidence interval (Clopper-Pearson method) was calculated for the percentage of participants experiencing PE in Dabigatran group.|||0.82|0.00|
72478427|NCT00558259|144482608|SUPERIORITY_OR_OTHER||Percentage of participants with events|2.1|||||TWO_SIDED|95.0|1.16|3.52|||||The confidence interval (Clopper-Pearson method) was calculated for the percentage of participants experiencing PE in placebo group.|||3.52|1.16|
72478428|NCT00558259|144482609|SUPERIORITY_OR_OTHER|||||||0.2428|||||||Fisher Exact|||Dabigatran vs. Placebo||||0.2428
72478429|NCT00558259|144482609|SUPERIORITY_OR_OTHER||Percentage of participants with events|0.0|||||TWO_SIDED|95.0|0.0|0.54|||||The confidence interval (Clopper-Pearson method) was calculated for the percentage of participants with unexplained death in Dabigatran group.|||0.54|0.00|
72478430|NCT00558259|144482609|SUPERIORITY_OR_OTHER||Percentage of participants with events|0.3|||||TWO_SIDED|95.0|0.04|1.09|||||The confidence interval (Clopper-Pearson method) was calculated for the percentage of participants with unexplained death in placebo group.|||1.09|0.04|
72478431|NCT00558259|144482610|SUPERIORITY_OR_OTHER|||||||0.4998||||||As the Cox model did not converge due to too few events, hazard ratios are not estimable.|Fisher Exact|||Dabigatran vs. Placebo - Analysis of time to first occurrence of an MBE during the treatment period - FAS - as treated.||||0.4998
72478432|NCT00558259|144482610|SUPERIORITY_OR_OTHER||Percentage of participants with events|0.3|||||TWO_SIDED|95.0|0.04|1.05|||||The confidence interval (Clopper-Pearson method) was calculated for the percentage of participants experiencing MBE in Dabigatran group.|||1.05|0.04|
72478433|NCT00558259|144482610|SUPERIORITY_OR_OTHER||Percentage of participants with events|0.0|||||TWO_SIDED|95.0|0.0|0.56|||||The confidence interval (Clopper-Pearson method) was calculated for the percentage of participants experiencing MBE in placebo group.|||0.56|0.00|
72478434|NCT00558259|144482610|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.92|STANDARD_ERROR_OF_MEAN|0.97||0.0013|TWO_SIDED|95.0|1.52|5.6|||Regression, Cox|||Dabigatran vs. Placebo- Analysis of time to first occurrence of a MBE or CRBE during the treatment period - FAS - as treated.||5.60|1.52|0.0013
72478435|NCT00558259|144482610|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.82|STANDARD_ERROR_OF_MEAN|0.36||0.0027|TWO_SIDED|95.0|1.23|2.68|||Regression, Cox|||Dabigatran vs. Placebo- Analysis of time to first occurrence of any bleeding event during the treatment period - FAS - as treated||2.68|1.23|0.0027
72478436|NCT02874924|144482613|EQUIVALENCE|Pilot study, therefore, no power calculation available.|Mean Difference (Net)|-1.81||||0.56|TWO_SIDED|95.0|-8.48|4.86|||t-test, 2 sided|||Null hypothesis||4.86|-8.48|0.56
72478437|NCT00822172|144482634|SUPERIORITY|||||||0.076|||||||two-sample equal-variances t-test|||||||0.076
72478438|NCT00822172|144482635|SUPERIORITY|||||||0.048|||||||two-sample equal-variances t-test|||||||0.048
72478439|NCT00822172|144482636|SUPERIORITY|||||||0.65|||||||two-sample equal-variances t-test|||||||0.650
72478440|NCT01874431|144482664|OTHER||Least square mean ratio|0.926||||0.1973|TWO_SIDED|90.0|0.799|1.074|||t-test, 1 sided|||To demonstrate a dose-dependent effect of finerenone, an analysis of covariance (ANCOVA) with factors treatment group, type of albuminuria at screening and region, and log-transformed baseline value as covariate nested within type of albuminuria at screening was performed in the FAS using a last-observation carried-forward (LOCF) method for missing observations.||1.074|0.799|0.1973
72478441|NCT01874431|144482664|OTHER||Least square mean ratio|0.949||||0.2808|TWO_SIDED|90.0|0.818|1.101|||t-test, 1 sided|||To demonstrate a dose-dependent effect of finerenone, an ANCOVA with factors treatment group, type of albuminuria at screening and region, and log-transformed baseline value as covariate nested within type of albuminuria at screening was performed in the FAS using a LOCF method for missing observations.||1.101|0.818|0.2808
72478442|NCT01874431|144482664|OTHER||Least square mean ratio|0.878||||0.0723|TWO_SIDED|90.0|0.758|1.017|||t-test, 1 sided|||To demonstrate a dose-dependent effect of finerenone, an ANCOVA with factors treatment group, type of albuminuria at screening and region, and log-transformed baseline value as covariate nested within type of albuminuria at screening was performed in the FAS using a LOCF method for missing observations.||1.017|0.758|0.0723
72478443|NCT01874431|144482664|OTHER||Least square mean ratio|0.787||||0.0039|TWO_SIDED|90.0|0.68|0.912|||t-test, 1 sided|||To demonstrate a dose-dependent effect of finerenone, an ANCOVA with factors treatment group, type of albuminuria at screening and region, and log-transformed baseline value as covariate nested within type of albuminuria at screening was performed in the FAS using a LOCF method for missing observations.||0.912|0.68|0.0039
72478444|NCT01874431|144482664|OTHER||Least square mean ratio|0.755||||0.0009|TWO_SIDED|90.0|0.651|0.875|||t-test, 1 sided|||To demonstrate a dose-dependent effect of finerenone, an ANCOVA with factors treatment group, type of albuminuria at screening and region, and log-transformed baseline value as covariate nested within type of albuminuria at screening was performed in the FAS using a LOCF method for missing observations.||0.875|0.651|0.0009
72478445|NCT01874431|144482664|OTHER||Least square mean ratio|0.671|||<|0.0001|TWO_SIDED|90.0|0.584|0.772|||t-test, 1 sided|||To demonstrate a dose-dependent effect of finerenone, an ANCOVA with factors treatment group, type of albuminuria at screening and region, and log-transformed baseline value as covariate nested within type of albuminuria at screening was performed in the FAS using a LOCF method for missing observations.||0.772|0.584|< 0.0001
72478446|NCT01874431|144482664|OTHER||Least square mean ratio|0.624|||<|0.0001|TWO_SIDED|90.0|0.542|0.718|||t-test, 1 sided|||To demonstrate a dose-dependent effect of finerenone, an ANCOVA with factors treatment group, type of albuminuria at screening and region, and log-transformed baseline value as covariate nested within type of albuminuria at screening was performed in the FAS using a LOCF method for missing observations.||0.718|0.542|< 0.0001
72478447|NCT01874431|144482665|OTHER||Least squares mean difference|0.107||||0.0428|TWO_SIDED|95.0|0.003|0.21|||t-test, 2 sided|||||0.21|0.003|0.0428
72478448|NCT01874431|144482665|OTHER||Least squares mean difference|0.121||||0.0223|TWO_SIDED|95.0|0.017|0.225|||t-test, 2 sided|||||0.225|0.017|0.0223
72478449|NCT01874431|144482665|OTHER||Least squares mean difference|0.2||||0.0002|TWO_SIDED|95.0|0.096|0.305|||t-test, 2 sided|||||0.305|0.096|0.0002
72478450|NCT01874431|144482665|OTHER||Least squares mean difference|0.125||||0.0181|TWO_SIDED|95.0|0.021|0.229|||t-test, 2 sided|||||0.229|0.021|0.0181
72478451|NCT01874431|144482665|OTHER||Least squares mean difference|0.166||||0.0019|TWO_SIDED|95.0|0.061|0.27|||t-test, 2 sided|||||0.27|0.061|0.0019
72478452|NCT01874431|144482665|OTHER||Least squares mean difference|0.236|||<|0.0001|TWO_SIDED|95.0|0.137|0.334|||t-test, 2 sided|||||0.334|0.137|< 0.0001
72509006|NCT01128972|144548340|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|7.14|||<|0.0001|TWO_SIDED|95.0|4.11|10.18||No adjustments made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment, study period, and subject (random effect).|Difference is first named treatment minus second named treatment such that a positive difference favours the first named treatment.|Null hypothesis considered population means for the Test Dentifrice + Sterile water rinse treatment regimen and Reference Dentifrice + Sterile water rinse to be equal with respect to percent SMH recovery. Statistical tests were 2-sided with a significance level of 0.05.||10.18|4.11|<0.0001
72509007|NCT02429427|144548343|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.751|TWO_SIDED|95.0|0.8|1.17|||Log Rank|Analysis stratified by oestrogen receptor status and country.|Analysis stratified by oestrogen receptor status and country.|||1.17|0.80|0.751
72478453|NCT01874431|144482665|OTHER||Least squares mean difference|0.186||||0.0002|TWO_SIDED|95.0|0.088|0.284|||t-test, 2 sided|||||0.284|0.088|0.0002
72478454|NCT01874431|144482666|OTHER||Least squares mean difference|-0.786||||0.5454|TWO_SIDED|95.0|-3.337|1.765|||t-test, 2 sided|||||1.765|-3.337|0.5454
72478455|NCT01874431|144482666|OTHER||Least squares mean difference|-1.61||||0.2186|TWO_SIDED|95.0|-4.177|0.957|||t-test, 2 sided|||||0.957|-4.177|0.2186
72478456|NCT01874431|144482666|OTHER||Least squares mean difference|-0.918||||0.4859|TWO_SIDED|95.0|-3.503|1.667|||t-test, 2 sided|||||1.667|-3.503|0.4859
72478457|NCT01874431|144482666|OTHER||Least squares mean difference|-1.8||||0.1677|TWO_SIDED|95.0|-4.358|0.759|||t-test, 2 sided|||||0.759|-4.358|0.1677
72478458|NCT01874431|144482666|OTHER||Least squares mean difference|-2.613||||0.0462|TWO_SIDED|95.0|-5.183|-0.044|||t-test, 2 sided|||||-0.044|-5.183|0.0462
72478459|NCT01874431|144482666|OTHER||Least squares mean difference|-2.228||||0.0705|TWO_SIDED|95.0|-4.643|0.187|||t-test, 2 sided|||||0.187|-4.643|0.0705
72478460|NCT01874431|144482666|OTHER||Least squares mean difference|-2.446||||0.048|TWO_SIDED|95.0|-4.869|-0.022|||t-test, 2 sided|||||-0.022|-4.869|0.048
72478461|NCT01874431|144482667|OTHER||Least square mean difference|-2.863||||0.0757|TWO_SIDED|95.0|-6.022|0.297|||t-test, 2 sided|||||0.297|-6.022|0.0757
72478462|NCT01874431|144482667|OTHER||Least square mean difference|-0.643||||0.6941|TWO_SIDED|95.0|-3.851|2.565|||t-test, 2 sided|||||2.565|-3.851|0.6941
72478463|NCT01874431|144482667|OTHER||Least square mean difference|-1.976||||0.2228|TWO_SIDED|95.0|-5.155|1.203|||t-test, 2 sided|||||1.203|-5.155|0.2228
72478464|NCT01874431|144482667|OTHER||Least square mean difference|-1.932||||0.2313|TWO_SIDED|95.0|-5.098|1.234|||t-test, 2 sided|||||1.234|-5.098|0.2313
72478465|NCT01874431|144482667|OTHER||Least square mean difference|-3.342||||0.0386|TWO_SIDED|95.0|-6.509|-0.176|||t-test, 2 sided|||||-0.176|-6.509|0.0386
72509008|NCT02429427|144548344|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.781|TWO_SIDED|95.0|0.76|1.22|||Log Rank|Analysis is stratified for oestrogen receptor status and country.|Analysis is stratified for oestrogen receptor status and country.|||1.22|0.76|0.781
72478466|NCT01874431|144482667|OTHER||Least square mean difference|-0.634||||0.677|TWO_SIDED|95.0|-3.624|2.355|||t-test, 2 sided|||||2.355|-3.624|0.677
72478467|NCT01874431|144482667|OTHER||Least square mean difference|-0.688||||0.6536|TWO_SIDED|95.0|-3.699|2.322|||t-test, 2 sided|||||2.322|-3.699|0.6536
72509009|NCT00747617|144548347|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Mixed Models Analysis|||||||<0.05
72509010|NCT02279524|144548357|SUPERIORITY||Difference in least square means|-3.09||||0.0655|TWO_SIDED|1.6|||||Mixed Models Analysis||||Post-Hoc Responder Analysis - was also carried out. See Post-Hoc analysis|||0.0655
72509011|NCT02279524|144548357|SUPERIORITY||Difference in least square means|-3.32||||0.045|TWO_SIDED|1.6|||||Mixed Models Analysis||||Post-Hoc Responder Analysis - was also carried out. See Post-Hoc analysis|||0.0450
72509012|NCT02279524|144548358|SUPERIORITY||Odds Ratio (OR)|4.74||||0.0514|TWO_SIDED|95.0|0.99|22.66|||Regression, Logistic|The method used was a Baseline Adjusted Logistic Regression||||22.66|0.99|0.0514
72509013|NCT02279524|144548358|SUPERIORITY||Odds Ratio (OR)|1.79||||0.4955|TWO_SIDED|95.0|0.33|9.61|||Regression, Logistic|||||9.61|0.33|0.4955
72509014|NCT02279524|144548359|SUPERIORITY||Odds Ratio (OR)|1.88||||0.211|TWO_SIDED|95.0|0.7|5.04|||Regression, Logistic|||||5.04|0.70|0.2110
72509015|NCT02279524|144548359|SUPERIORITY||Odds Ratio (OR)|1.11||||0.8425|TWO_SIDED|95.0|0.4|3.05|||Regression, Logistic|||||3.05|0.40|0.8425
72478468|NCT01874431|144482668|OTHER||Least square mean difference|-3.044||||0.0816|TWO_SIDED|95.0|-6.471|0.383|||t-test, 2 sided|||||0.383|-6.471|0.0816
72478469|NCT01874431|144482668|OTHER||Least square mean difference|-0.537||||0.7625|TWO_SIDED|95.0|-4.027|2.953|||t-test, 2 sided|||||2.953|-4.027|0.7625
72509016|NCT02279524|144548360|SUPERIORITY||Difference in least square means|-29.1|STANDARD_ERROR_OF_MEAN|6.4|<|0.0001|TWO_SIDED||||||Mixed Models Analysis|||||||< 0.0001
72478470|NCT01874431|144482668|OTHER||Least square mean difference|-1.301|||=|0.4603|TWO_SIDED|95.0|-4.759|2.157|||t-test, 2 sided|||||2.157|-4.759|= 0.4603
72478471|NCT01874431|144482668|OTHER||Least square mean difference|-1.574||||0.3678|TWO_SIDED|95.0|-5.004|1.855|||t-test, 2 sided|||||1.855|-5.004|0.3678
72509017|NCT02279524|144548360|SUPERIORITY||Difference in least square means|-23.8|STANDARD_ERROR_OF_MEAN|6.3||0.0002|TWO_SIDED||||||Mixed Models Analysis|||||||0.0002
72509018|NCT02279524|144548361|SUPERIORITY||Difference in least square means|-0.447||||0.0008|TWO_SIDED|95.0|-0.7063|-0.1877|||Mixed Models Analysis|||||-0.1877|-0.7063|0.0008
72509019|NCT02279524|144548361|SUPERIORITY||Difference in least square means|-0.362||||0.0061|TWO_SIDED|95.0|-0.6196|-0.1043|||Mixed Models Analysis|||||-0.1043|-0.6196|0.0061
72509020|NCT02279524|144548362|SUPERIORITY||Difference in least square means|-17.5|STANDARD_ERROR_OF_MEAN|4.2|<|0.0001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.0001
72509021|NCT02279524|144548362|SUPERIORITY||Difference in least square means|-13.9|STANDARD_ERROR_OF_MEAN|4.2||0.0011|TWO_SIDED||||||Mixed Models Analysis|||||||0.0011
72509022|NCT02279524|144548363|SUPERIORITY||Odds Ratio (OR)|2.77||||0.0279|TWO_SIDED|95.0|1.11|6.88|||Mixed Models Analysis|||||6.88|1.11|0.0279
72509023|NCT02279524|144548363|SUPERIORITY||Odds Ratio (OR)|2.2||||0.0878|TWO_SIDED|95.0|0.89|5.46|||Regression, Logistic|||||5.46|0.89|0.0878
72509024|NCT02279524|144548364|SUPERIORITY||Odds Ratio (OR)|0.14||||0.1008|TWO_SIDED|95.0|0.01|1.46|||Regression, Logistic||This analysis is limited by low number of events, and the duration of the study.|||1.46|0.01|0.1008
72509025|NCT02279524|144548364|SUPERIORITY||Odds Ratio (OR)|0.63||||0.5693|TWO_SIDED|95.0|0.13|3.05|||Regression, Logistic||This analysis is limited by low number of events, and the duration of the study.|||3.05|0.13|0.5693
72509026|NCT00137436|144548377|SUPERIORITY_OR_OTHER|||||||0.942||95.0|||||Wilcoxon rank-sum test|||C1D14 : C1D1||||0.942
72509027|NCT00137436|144548377|SUPERIORITY_OR_OTHER|||||||0.323||95.0|||||Wilcoxon rank-sum test|||C2.D1 : C1D1||||0.323
72509028|NCT00137436|144548377|SUPERIORITY_OR_OTHER|||||||0.865||95.0|||||Wilcoxon rank-sum test|||C2.D14 : C1D1||||0.865
72509029|NCT00137436|144548377|SUPERIORITY_OR_OTHER|||||||0.873||95.0|||||Wilcoxon rank-sum test|||C3.D14 : C1D1||||0.873
72509030|NCT00137436|144548378|SUPERIORITY_OR_OTHER|||||||0.736||95.0|||||Wilcoxon rank-sum test|||C1D14 : C1D1||||0.736
72509031|NCT00137436|144548378|SUPERIORITY_OR_OTHER|||||||0.962||95.0|||||Wilcoxon rank-sum test|||C2.D1 : C1D1||||0.962
72509032|NCT00137436|144548378|SUPERIORITY_OR_OTHER|||||||0.185||95.0|||||Wilcoxon rank-sum test|||C2.D14 : C1D1||||0.185
72509033|NCT00137436|144548378|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Wilcoxon rank-sum test|||C3.D14 : C1D1||||1.000
72478472|NCT01874431|144482668|OTHER||Least square mean difference|-1.727||||0.3279|TWO_SIDED|95.0|-5.191|1.736|||t-test, 2 sided|||||1.736|-5.191|0.3279
72478473|NCT01874431|144482668|OTHER||Least square mean difference|-1.682||||0.3102|TWO_SIDED|95.0|-4.935|1.57|||t-test, 2 sided|||||1.57|-4.935|0.3102
72509034|NCT00137436|144548379|SUPERIORITY_OR_OTHER|||||||0.386||95.0|||||Wilcoxon rank-sum test|||C1D14 : C1D1||||0.386
72509035|NCT00137436|144548379|SUPERIORITY_OR_OTHER|||||||0.904||95.0|||||Wilcoxon rank-sum test|||C2.D1 : C1D1||||0.904
72509036|NCT00137436|144548379|SUPERIORITY_OR_OTHER|||||||0.812||95.0|||||Wilcoxon rank-sum test|||C2.D14 : C1D1||||0.812
72509037|NCT00137436|144548379|SUPERIORITY_OR_OTHER|||||||0.49||95.0|||||Wilcoxon rank-sum test|||C3.D14 : C1D1||||0.490
72509038|NCT00137436|144548380|SUPERIORITY_OR_OTHER|||||||0.839||95.0|||||Wilcoxon rank-sum test|||C1D14 : C1D1||||0.839
72509039|NCT00137436|144548380|SUPERIORITY_OR_OTHER|||||||0.219||95.0|||||Wilcoxon rank-sum test|||C2.D1 : C1D1||||0.219
72509040|NCT00137436|144548380|SUPERIORITY_OR_OTHER|||||||0.788||95.0|||||Wilcoxon rank-sum test|||C2.D14 : C1D1||||0.788
72509041|NCT00137436|144548380|SUPERIORITY_OR_OTHER|||||||0.164||95.0|||||Wilcoxon rank-sum test|||C3.D14 : C1D1||||0.164
72509042|NCT00137436|144548381|SUPERIORITY_OR_OTHER|||||||0.656||95.0|||||Wilcoxon rank-sum test|||C1D14 : C1D1||||0.656
72509043|NCT00137436|144548381|SUPERIORITY_OR_OTHER|||||||0.628||95.0|||||Wilcoxon rank-sum test|||C2.D1 : C1D1||||0.628
72509044|NCT00137436|144548381|SUPERIORITY_OR_OTHER|||||||0.42||95.0|||||Wilcoxon rank-sum test|||C2.D14 : C1D1||||0.420
72509045|NCT00137436|144548381|SUPERIORITY_OR_OTHER|||||||0.296||95.0|||||Wilcoxon rank-sum test|||C3.D14 : C1D1||||0.296
72399979|NCT02337907|144307832|SUPERIORITY|H0: The dose group with the peak response in the respective model Mean NTB response = Mean NTB response of placebo.|Mean Difference (Net)|0.01|STANDARD_ERROR_OF_MEAN|0.071||0.8789|TWO_SIDED|95.0|-0.13|0.152||p-value was nominal and not adjusted.|Mixed Model Repeated Measurement (MMRM)|Kenward-Roger was used to model degrees of freedom.|The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|Mixed Model Repeated Measurement (MMRM) includes fixed, categorical effects of treatment, visit, current Acetylcholine Esterase Inhibitor (AChEI) use (Yes, No), and treatment-by-visit interaction, as well as the continuous fixed covariates of baseline, and baseline-by-visit interaction.||0.152|-0.130|0.8789
72623409|NCT03809000|144777660|SUPERIORITY||Hazard Ratio (HR)|0.72||||0.1396|TWO_SIDED|80.0|0.56|0.94|||Log Rank|One-sided significance level = 0.10|Reference level = standard ADT|After protocol amendments, the 3-year PFS rate of the standard arm was expected to be 24%. Assuming a hazard ratio of 0.65 (treatment/control) results in a hypothesized 3-year PFS rate of 39.5% on the enhanced ADT arm. A one-sided log-rank test with alpha=0.10 at 80% statistical power was calculated to require 101 events from 170 patients, taking into account expected accrual rate and follow-up time.||0.94|0.56|0.1396
72478474|NCT01874431|144482668|OTHER||Least square mean difference|-2.511||||0.1317|TWO_SIDED|95.0|-5.778|0.755|||t-test, 2 sided|||||0.755|-5.778|0.1317
72478475|NCT00545051|144482685|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.25|||<|0.001|TWO_SIDED|95.0|2.09|4.41|||ANCOVA|||||4.41|2.09|<0.001
72478476|NCT00545051|144482686|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.22|||<|0.001|TWO_SIDED|95.0|1.22|3.23|||ANCOVA|||||3.23|1.22|<0.001
72478477|NCT00545051|144482687|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.55||||0.122|TWO_SIDED|95.0|-0.15|1.25|||ANCOVA|||Month 6||1.25|-0.15|0.122
72478478|NCT00545051|144482687|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.81|||<|0.001|TWO_SIDED|95.0|0.96|2.66|||ANCOVA|||Month 12||2.66|0.96|<0.001
72478479|NCT00545051|144482688|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANCOVA|||sCTX at Month 1||||<0.001
72478480|NCT00545051|144482688|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANCOVA|||sCTX at Month 6||||<0.001
72478481|NCT00545051|144482688|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANCOVA|||sCTX at Month 12||||<0.001
72478482|NCT00545051|144482688|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANCOVA|||P1NP at Month 1||||<0.001
72478483|NCT00545051|144482688|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANCOVA|||P1NP at Month 6||||<0.001
72478484|NCT00545051|144482688|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANCOVA|||P1NP at Month 12||||<0.001
72478485|NCT00545051|144482688|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANCOVA|||TRACP at Month 1||||<0.001
72478486|NCT00545051|144482688|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANCOVA|||TRACP at Month 6||||<0.001
72478487|NCT00545051|144482688|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANCOVA|||TRACP at Month 12||||<0.001
72478488|NCT01383499|144482700|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.087|STANDARD_ERROR_OF_MEAN|0.023||0.0002|TWO_SIDED|95.0|0.042|0.132||First step of closed testing procedure, where the active treatments are compared to placebo. If this statistical test significant at the 0.05 alpha level then proceed to comparison of the next lower dose to placebo.|Mixed model repeated measures (MMRM)|This MMRM model includes treatment, period and baseline as fixed effects, and patient as random effect.||Tio R5 minus Placebo||0.132|0.042|0.0002
72478489|NCT01383499|144482700|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.104|STANDARD_ERROR_OF_MEAN|0.023|<|0.0001|TWO_SIDED|95.0|0.059|0.149||Second step of closed testing procedure. If this statistical test significant at the 0.05 alpha level then proceed to comparison of the next lower dose to placebo.|Mixed model repeated measures (MMRM)|This MMRM model includes treatment, period and baseline as fixed effects, and patient as random effect.||Tio R2.5 minus Placebo||0.149|0.059|<.0001
72478490|NCT01383499|144482700|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.075|STANDARD_ERROR_OF_MEAN|0.023||0.0011|TWO_SIDED|95.0|0.03|0.12|||Mixed model repeated measures (MMRM)|This MMRM model includes treatment, period and baseline as fixed effects, and patient as a random effect.||Tio R1.25 minus Placebo||0.120|0.030|0.0011
72478491|NCT01383499|144482700|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.012|STANDARD_ERROR_OF_MEAN|0.023|||TWO_SIDED|95.0|-0.034|0.057|||Mixed model repeated measures (MMRM)|||Tio R5 minus Tio R1.25||0.057|-0.034|
72478492|NCT01383499|144482700|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.017|STANDARD_ERROR_OF_MEAN|0.023|||TWO_SIDED|95.0|-0.063|0.028|||Mixed model repeated measures (MMRM)|||Tio R5 minus Tio R2.5||0.028|-0.063|
72478493|NCT01383499|144482700|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.029|STANDARD_ERROR_OF_MEAN|0.023|||TWO_SIDED|95.0|-0.016|0.074|||Mixed models repeated measures (MMRM)|||Tio R2.5 minus Tio R1.25||0.074|-0.016|
72478494|NCT02469389|144482711|SUPERIORITY|Based on randomization to treatment condition, the model assumed no differences at BL (any difference was assumed due to random sampling error).||||||0.295|||||||Mixed Models Analysis|Post-hoc mixed effects model analyses of all outcomes were performed adjusting for BL CAINS MAP score.||Analyses of the primary and secondary outcomes utilized a linear mixed effects model accounting for random therapy group effects and included all available data at baseline (BL), post-treatment (PT; 12-week), and follow-up (FU; 24-week) timepoints (TPs). Error terms across TPs were assumed correlated with unstructured correlation matrix. To test time specific hypotheses, terms in the mean model included separate indicators for PT \& FU \& interaction terms between these indicators and conditions.||||0.295
72478495|NCT02469389|144482712|SUPERIORITY|||||||0.182|||||||Mixed Models Analysis|||||||0.182
72478496|NCT02469389|144482713|SUPERIORITY|||||||0.114|||||||Mixed Models Analysis|||||||0.114
72478497|NCT02469389|144482714|SUPERIORITY|||||||0.22|||||||Mixed Models Analysis|||||||0.220
72478498|NCT02469389|144482715|SUPERIORITY|||||||0.018|||||||Mixed Models Analysis|||||||0.018
72478499|NCT02469389|144482716|SUPERIORITY|||||||0.903|||||||Mixed Models Analysis|||||||0.903
72478500|NCT02469389|144482717|SUPERIORITY|||||||0.535|||||||Mixed Models Analysis|||||||0.535
72478501|NCT02469389|144482718|SUPERIORITY|||||||0.01|||||||Mixed Models Analysis|||||||0.010
72478502|NCT02469389|144482719|SUPERIORITY|||||||0.692|||||||Mixed Models Analysis|||||||0.692
72478503|NCT02469389|144482720|SUPERIORITY|||||||0.498|||||||Mixed Models Analysis|||||||0.498
72478504|NCT02469389|144482721|SUPERIORITY|||||||0.079|||||||Mixed Models Analysis|||||||0.079
72478505|NCT02469389|144482722|SUPERIORITY|||||||0.539|||||||Mixed Models Analysis|||||||0.539
72478506|NCT01079663|144482730|SUPERIORITY||Mean Difference (Final Values)|-0.49||||0.1629|TWO_SIDED|95.0|-1.19|0.2|||Mixed Models Analysis|||||0.20|-1.19|0.1629
72478507|NCT01079663|144482731|SUPERIORITY||Mean Difference (Final Values)|-0.76||||0.0347|TWO_SIDED|95.0|-1.46|-0.06|||Mixed Models Analysis|||||-0.06|-1.46|0.0347
72478508|NCT03038438|144482736|OTHER|Single arm study with a hypothesis test comparing to performance goal|Proportion|88.0|||<|0.0001|ONE_SIDED|97.5|82.5||||Fisher Exact|||"The primary effectiveness endpoint, primary patency at 12 months, was tested against a PG of 75%. The null and alternative hypotheses tested appear below:~H0: π ≤ PG vs. HA: π \> PG where π is the primary patency rate at 12 months in the study population and PG is the performance goal of 75%. The primary effectiveness objective will be met if the lower limit of the 97.5% one-sided confidence interval is above 75%."|||82.5|<0.0001
72478509|NCT03038438|144482737|OTHER|Single-arm study with a hypothesis test comparing to performance goal|Proportion|2.0|||<|0.0001|ONE_SIDED|97.5||5.0|||Fisher Exact|||"The primary safety endpoint, major adverse events at 30 days post-procedure, was tested against a performance goal of 12.5%. The null and alternative hypotheses tested appear below:~H0: P ≥ PG vs. HA: P \< PG where P is the primary safety endpoint at 30 days in the study population and PG is the performance goal.~The primary safety objective will be met if the upper limit of the 97.5% one-sided confidence interval is below 12.5%."||5.0||<0.0001
72478510|NCT02476279|144482761|NON_INFERIORITY|To declare noninferiority, the upper bound of the two-sided 95% CI for the risk difference in post-ERCP pancreatitis (indomethacin alone minus indomethacin plus stent) needed to be less than 5% in both the intention-to-treat and per protocol analysis populations.|Risk Difference (RD)|0.036|||||TWO_SIDED|95.0|0.006|0.066|||||These numbers are in the intention-to-treat analysis population. Risk difference in post-ERCP pancreatitis (PEP) is calculated as risk of PEP in indomethacin alone arm minus risk of PEP in indomethacin plus stent arm.|||0.066|0.006|
72509046|NCT00137436|144548382|SUPERIORITY_OR_OTHER|||||||0.903||95.0|||||Wilcoxon rank-sum test|||C1D14 : C1D1||||0.903
72509047|NCT00137436|144548382|SUPERIORITY_OR_OTHER|||||||0.434||95.0|||||Wilcoxon rank-sum test|||C2.D1 : C1D1||||0.434
72509048|NCT00137436|144548382|SUPERIORITY_OR_OTHER|||||||0.687||95.0|||||Wilcoxon rank-sum test|||C2.D14 : C1D1||||0.687
72509049|NCT00137436|144548382|SUPERIORITY_OR_OTHER|||||||0.296||95.0|||||Wilcoxon rank-sum test|||C3.D14 : C1D1||||0.296
72566464|NCT02697773|144663278|SUPERIORITY||Least Square Mean Difference|-0.64|STANDARD_ERROR_OF_MEAN|0.23||0.0058|TWO_SIDED|95.0|-1.09|-0.18|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.||-0.18|-1.09|0.0058
72566465|NCT02697773|144663278|SUPERIORITY||Least Square Mean Difference|-0.86|STANDARD_ERROR_OF_MEAN|0.23||0.0002|TWO_SIDED|95.0|-1.31|-0.41|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.||-0.41|-1.31|0.0002
72478511|NCT02476279|144482761|NON_INFERIORITY|To declare noninferiority, the upper bound of the two-sided 95% CI for the risk difference in post-ERCP pancreatitis (indomethacin alone minus indomethacin plus stent) needed to be less than 5% in both the intention-to-treat and per protocol analysis populations.|Risk Difference (RD)|0.028|||||TWO_SIDED|95.0|-0.003|0.06|||||These numbers are in the per protocol analysis population. Risk difference in post-ERCP pancreatitis (PEP) is calculated as risk of PEP in indomethacin alone arm minus risk of PEP in indomethacin plus stent arm.|||0.060|-0.003|
72566466|NCT02697773|144663278|SUPERIORITY||Least Square Mean Difference|-0.98|STANDARD_ERROR_OF_MEAN|0.24|<|0.0001|TWO_SIDED|95.0|-1.44|-0.51|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.||-0.51|-1.44|<.0001
72478512|NCT02476279|144482762|OTHER||Risk Difference (RD)|0.021|||||TWO_SIDED|95.0|-0.002|0.043|||||These numbers are in the intention-to-treat analysis population. Risk difference is calculated as risk of moderate-severe PEP in indomethacin alone arm minus risk of moderate-severe PEP in indomethacin plus stent arm.|||0.043|-0.002|
72509050|NCT00738543|144548387|NON_INFERIORITY_OR_EQUIVALENCE|A minimal sample of 20 volunteers was calculated to to find a difference of 200 CFU/mL, with a power of 80% and bilateral error of 5%.|||||<|0.05||||||Post-hoc test of Kruskal-Wallis for multiple comparisons of Z values was used to determine which arm was different.|Kruskal-Wallis|2 degrees of freedom corrected for ties||The null hypothesis established that the three medians were equal. To test significant differences for non-normally distributed data, a range test (Kruskal-Wallis) was used.||||<0.05
72509051|NCT00738543|144548389|NON_INFERIORITY_OR_EQUIVALENCE|The minimal sample of 20 volunteers was calculated to find a difference of 200 CFU/mL.|||||<|0.05||95.0||||Post-hoc test of Kruskal-Wallis for multiple comparisons of Z values was used to determine which arm was different.|Kruskal-Wallis|2 degrees of freedom corrected for ties||The null hypothesis established that the 3 medians were equal. To test significant differences for non-normally distributed data, a range test (Kruskal-Wallis) was used. The alpha level for significance was established at 5%. A minimal sample of 20 volunteers was calculated for a power of 80%, and bilateral error of 5%.||||<0.05
72509052|NCT02361762|144548428|OTHER|||||||0.36|||||||ANCOVA|ANCOVA-of-change was used to compare the Training and Waitlist groups at post-testing while controlling for baseline (baseline was co-varied)||||||0.36
72509053|NCT02361762|144548429|OTHER|||||||0.79|||||||ANCOVA|ANCOVA-of-change was used to compare the Training and Waitlist groups at post-testing while controlling for baseline (baseline was co-varied)||||||0.79
72509054|NCT02361762|144548430|OTHER|||||||0.009|||||||ANOVA|Repeated measures ANOVA compared group (Training/Waitlist) by time (Pre/Post) by condition (Congruent/Incongruent)||||||0.009
72509055|NCT02361762|144548431|OTHER|||||||0.79||||||ANCOVA-of-change was used to compare the Training and Waitlist groups at post-testing while controlling for baseline (baseline was co-varied)|ANCOVA|Compared scores at post testing with baseline scores covaried.||||||.79
72509056|NCT02361762|144548432|OTHER|||||||0.61|||||||ANCOVA|ANCOVA-of-change was used to compare the Training and Waitlist groups at post-testing while controlling for baseline (baseline was co-varied)||||||0.61
72399980|NCT02337907|144307832|SUPERIORITY|H0: The dose group with the peak response in the respective model Mean NTB response = Mean NTB response of placebo.|Mean Difference (Final Values)|-0.14|STANDARD_ERROR_OF_MEAN|0.074||0.0609|TWO_SIDED|95.0|-0.285|0.006||p-value was nominal and not adjusted.|Mixed Model Repeated Measurement (MMRM)|Kenward-Roger was used to model degrees of freedom.|The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences|Mixed Model Repeated Measurement (MMRM) includes fixed, categorical effects of treatment, visit, current Acetylcholine Esterase Inhibitor (AChEI) use (Yes, No), and treatment-by-visit interaction, as well as the continuous fixed covariates of baseline, and baseline-by-visit interaction.||0.006|-0.285|0.0609
72478513|NCT02476279|144482762|OTHER||Risk Difference (RD)|0.02|||||TWO_SIDED|95.0|-0.004|0.044|||||These numbers are in the per protocol analysis population. Risk difference is calculated as risk of moderate-severe PEP in indomethacin alone arm minus risk of moderate-severe PEP in indomethacin plus stent arm.|||0.044|-0.004|
72509057|NCT02361762|144548433|OTHER|||||||0.68|||||||ANCOVA|ANCOVA-of-change was used to compare the Training and Waitlist groups at post-testing while controlling for baseline (baseline was co-varied)0.||||||0.68
72509058|NCT02361762|144548434|OTHER|||||||0.54|||||||ANCOVA|ANCOVA-of-change was used to compare the Training and Waitlist groups at post-testing while controlling for baseline (baseline was co-varied)||||||0.54
72509059|NCT02361762|144548435|OTHER|||||||0.08|||||||ANCOVA|ANCOVA-of-change was used to compare the Training and Waitlist groups at post-testing while controlling for baseline (baseline was co-varied)||||||0.08
72478514|NCT00577473|144482763|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.0455||||0.4411|TWO_SIDED|95.0|-7.01|16.11||4.8 g/day compared to 2.4 g/day|Chi-squared|||It was assumed that the true rate of improvement for the 2.4 g/day treatment group is 40% and for the 4.8 g/day group is 60%. To detect a true difference of 20% between these 2 groups with a 2-sided test, type I error of 0.05 (α = 0.05), and power of 90%, 140 patients were required per group to complete the study. To account for a 10% dropout/withdrawal rate, approximately 308 patients were to be enrolled in the study.||16.11|-7.01|0.4411
72478515|NCT00577473|144482764|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.0331||||0.5677|TWO_SIDED|95.0|-14.67|8.04|||Chi-squared|||It was assumed that the true rate of improvement for the 2.4 g/day treatment group is 40% and for the 4.8 g/day group is 60%. To detect a true difference of 20% between these 2 groups with a 2-sided test, type I error of 0.05 (α = 0.05), and power of 90%, 140 patients were required per group to complete the study. To account for a 10% dropout/withdrawal rate, approximately 308 patients were to be enrolled in the study.||8.04|-14.67|0.5677
72478516|NCT00577473|144482765|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.0445||||0.473|TWO_SIDED|95.0|-16.6|7.7|||Chi-squared|||It was assumed that the true rate of improvement for the 2.4 g/day treatment group is 40% and for the 4.8 g/day group is 60%. To detect a true difference of 20% between these 2 groups with a 2-sided test, type I error of 0.05 (α = 0.05), and power of 90%, 140 patients were required per group to complete the study. To account for a 10% dropout/withdrawal rate, approximately 308 patients were to be enrolled in the study.||7.7|-16.6|0.4730
72478517|NCT00577473|144482766|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.0339||||0.5761|TWO_SIDED|95.0|-8.48|15.26|||Chi-squared|||It was assumed that the true rate of improvement for the 2.4 g/day treatment group is 40% and for the 4.8 g/day group is 60%. To detect a true difference of 20% between these 2 groups with a 2-sided test, type I error of 0.05 (α = 0.05), and power of 90%, 140 patients were required per group to complete the study. To account for a 10% dropout/withdrawal rate, approximately 308 patients were to be enrolled in the study.||15.26|-8.48|0.5761
72478518|NCT00577473|144482767|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.0766||||0.215|TWO_SIDED|95.0|-4.41|19.74|||Chi-squared|||It was assumed that the true rate of improvement for the 2.4 g/day treatment group is 40% and for the 4.8 g/day group is 60%. To detect a true difference of 20% between these 2 groups with a 2-sided test, type I error of 0.05 (α = 0.05), and power of 90%, 140 patients were required per group to complete the study. To account for a 10% dropout/withdrawal rate, approximately 308 patients were to be enrolled in the study.||19.74|-4.41|0.2150
72623410|NCT03360344|144777671|OTHER|non-parametric tests were used as data was not normally distributed.||||||0.48|||||||Wilcoxan signed Rank|||statistical analysis for wrist||||0.48
72478519|NCT00577473|144482768|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.0351||||0.5569|TWO_SIDED|95.0|-8.18|15.2|||Chi-squared|||It was assumed that the true rate of improvement for the 2.4 g/day treatment group is 40% and for the 4.8 g/day group is 60%. To detect a true difference of 20% between these 2 groups with a 2-sided test, type I error of 0.05 (α = 0.05), and power of 90%, 140 patients were required per group to complete the study. To account for a 10% dropout/withdrawal rate, approximately 308 patients were to be enrolled in the study.||15.20|-8.18|0.5569
72509060|NCT02361762|144548436|OTHER|||||||0.37|||||||ANCOVA|ANCOVA-of-change was used to compare the Training and Waitlist groups at post-testing while controlling for baseline (baseline was co-varied)||||||0.37
72509061|NCT02361762|144548438|OTHER|||||||0.62|||||||ANCOVA|ANCOVA-of-change was used to compare the Training and Waitlist groups at post-testing while controlling for baseline (baseline was co-varied)||||||0.62
72509062|NCT02361762|144548439|OTHER|||||||0.1|||||||ANCOVA|Repeated measures ANOVA compared group (Training/Waitlist) by time (Pre/Post) by condition (Go/Nogo)||||||0.10
72509063|NCT02361762|144548440|OTHER|||||||0.02|||||||ANCOVA|ANCOVA-of-change was used to compare the Training and Waitlist groups at post-testing while controlling for baseline (baseline was co-varied)||||||0.02
72509064|NCT05070429|144548457|SUPERIORITY||Maximum likelihood (MLE)|-0.035||||0.92|TWO_SIDED|95.0|-0.727|0.657||To account for the non-normal distribution of the outcome, confidence intervals and p-values were obtained using a bias corrected and accelerated bootstrap resampling procedure with 10,000 replicates.|generalized linear model (GLM)|generalized linear model (GLM) with an identity link|Confidence intervals and p-values were obtained using a bias-corrected and accelerated bootstrap resampling procedure with 10,000 replicates.|Used a weighted regression model with an identity link to compare average daily hours of hearing aid use at one-year post-randomization between participants assigned to the telehealth HHC or conventional HHC. Inverse probability of treatment weights will be calculated and included in the model for the primary outcome.||0.657|-0.727|0.92
72623411|NCT03360344|144777671|OTHER|nonparametric test were used as the distribution was not normal.||||||0.99|||||||Wilcoxan Signed Rank|||statistical analysis for forearm||||.99
72623412|NCT03360344|144777672|OTHER|||||||0.001|||||||ANOVA|||statistical analysis for forearm||||.001
72623413|NCT03360344|144777672|OTHER|||||||0.001|||||||ANOVA|||statistical analysis for wrist||||.001
72566467|NCT02697773|144663278|SUPERIORITY||Least Square Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|0.23|<|0.0001|TWO_SIDED|95.0|-1.56|-0.64|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.||-0.64|-1.56|<.0001
72566468|NCT02697773|144663278|SUPERIORITY||Least Square Mean Difference|-0.63|STANDARD_ERROR_OF_MEAN|0.24||0.0091|TWO_SIDED|95.0|-1.11|-0.16|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.||-0.16|-1.11|0.0091
72566469|NCT02697773|144663278|SUPERIORITY||Least Square Mean Difference|-0.44|STANDARD_ERROR_OF_MEAN|0.24||0.0668|TWO_SIDED|95.0|-0.92|0.03|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.||0.03|-0.92|0.0668
72623414|NCT03360344|144777673|OTHER|||||||0.06|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||.06
72623415|NCT03360344|144777674|OTHER|||||||0.01|||||||ANCOVA|||||||.01
72623416|NCT03360344|144777675|OTHER|||||||0.001|||||||Kruskal-Wallis|||||||.001
72623417|NCT03257657|144777687|OTHER|||||||0.1|||||||t-test, 2 sided|||||||0.1
72623418|NCT03257657|144777689|OTHER|||||||0.13|||||||t-test, 2 sided|||||||0.13
72623419|NCT03257657|144777691|OTHER|||||||0.02|||||||t-test, 2 sided|||||||0.02
72399981|NCT02337907|144307832|SUPERIORITY|H1-0: Mean NTB response of pooled doses of 10 mg QD, 25 mg QD, 25 mg BID and 50 mg QD = Mean NTB response of placebo|Mean Difference (Final Values)|-0.03|STANDARD_ERROR_OF_MEAN|0.053||0.5687|TWO_SIDED|95.0|-0.135|0.074||p-value was nominal and not adjusted.|Mixed Model Repeated Measurement (MMRM)|Kenward-Roger was used to model degrees of freedom.|The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences|Mixed Model Repeated Measurement (MMRM) includes fixed, categorical effects of treatment, visit, current Acetylcholine Esterase Inhibitor (AChEI) use (Yes, No), and treatment-by-visit interaction, as well as the continuous fixed covariates of baseline, and baseline-by-visit interaction.||0.074|-0.135|0.5687
72399982|NCT02337907|144307833|SUPERIORITY|H0: The dose group with the peak response in the respective model Mean NTB response = Mean NTB response of placebo.|Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.056||0.8694|TWO_SIDED|95.0|-0.101|0.12||p-value was nominal and not adjusted.|Mixed Model Repeated Measurement (MMRM)|Kenward-Roger was used to model degrees of freedom.|The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|Mixed Model Repeated Measurement (MMRM) includes fixed, categorical effects of treatment, visit, current Acetylcholine Esterase Inhibitor (AChEI) use (Yes, No), and treatment-by-visit interaction, as well as the continuous fixed covariates of baseline, and baseline-by-visit interaction. The study identifier is also a categorical covariate for the twin studies analyses.||0.120|-0.101|0.8694
72623420|NCT02296099|144777699|EQUIVALENCE|The Mann-Whitney U test was utilized.||||||0.014||||||The p-value was not adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|There were no adjustments.||The null hypothesis is that there is no difference in the pain scores between the two groups.||||0.014
72623421|NCT04033640|144777723|OTHER||||||<|0.001|||||||K-sample test|The p-value was calculated using a nonparametric k-sample test on the equality of medians.||Comparison of SD Biosensor POC G6PD test results for capillary and venous samples||||<0.001
72623422|NCT00688740|144777730|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.795||||0.0043|TWO_SIDED|95.0|0.679|0.932||Pairwise stratified log-rank test on the number of positive axillary nodes as per randomization|Log Rank|||||0.932|0.679|0.0043
72623423|NCT00688740|144777731|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.742||||0.002|TWO_SIDED|95.0|0.613|0.898||Pairwise stratified log-rank test on the number of positive axillary nodes as per randomization|Log Rank|||||0.898|0.613|0.0020
72623424|NCT00856557|144777734|SUPERIORITY_OR_OTHER|||||||0.33|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Null hypothesis is equal distribution of proportion of successful encounters among groups||||0.33
72623425|NCT00856557|144777734|SUPERIORITY_OR_OTHER||Odds Ratio, log|0.724|STANDARD_ERROR_OF_MEAN|0.346||0.036|TWO_SIDED||||||Mixed Models Analysis|||Considering all encounters (n=179) of all physicians for who outcomes were measured (n=111) together, are encounters in which physicians contextualized the plan of care more likely to be associated with target health outcome achievement than encounters in which physicians did not, controlling for clustering of encounters within physicians. (Generalized logistic mixed model, with random intercept for physician)||||.036
72623426|NCT00856557|144777735|SUPERIORITY_OR_OTHER|||||||0.99|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.99
72623427|NCT00856557|144777736|SUPERIORITY_OR_OTHER|||||||0.39|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.39
72623428|NCT01432444|144777737|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value was derived from Exact McNemar test.|McNemar|||Inpatient hospitalization for retrospective period (Months 4-6) and prospective period (Months 4-6) for closed or open unit.||||<.0001
72623429|NCT01432444|144777738|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Derived from T-test of Mean=0.|t-test|Mean duration was derived as the cumulative duration divided by the number of inpatient non-psychiatric hospitalization.||Statistical analyses for Week 4, 12 and 24.||||<.0001
72623430|NCT01432444|144777739|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Derived from T-test of Mean=0.|t-test, 2 sided|Mean duration was derived as the cumulative duration divided by the number of inpatient non-psychiatric hospitalization.||Statistical analyses for Week 4, Week 12 and Week 24.||||<.0001
72623431|NCT01432444|144777740|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Derived from T-test of Mean=0.|t-test, 2 sided|Mean duration was derived as the cumulative duration divided by the number of inpatient non-psychiatric hospitalization.||Statistical analysis for Week 4, 12 and 24.||||<.0001
72623432|NCT01432444|144777741|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Derived from t-test of mean=0.|t-test|||Statistical analysEs for Week 4, 12 and 24.||||<.0001
72623433|NCT02301897|144777752|SUPERIORITY|||||||0.0008|||||||Chi-Square Test|||||||0.0008
72623434|NCT02301897|144777752|SUPERIORITY||||||<|0.001|||||||Chi-Square Test|||||||<0.001
72399983|NCT02337907|144307833|SUPERIORITY|H0: The dose group with the peak response in the respective model Mean NTB response = Mean NTB response of placebo.|Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.057||0.9512|TWO_SIDED|95.0|-0.116|0.109||p-value was nominal and not adjusted.|Mixed Model Repeated Measurement (MMRM)|Kenward-Roger was used to model degrees of freedom.|The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|Mixed Model Repeated Measurement (MMRM) includes fixed, categorical effects of treatment, visit, current Acetylcholine Esterase Inhibitor (AChEI) use (Yes, No), and treatment-by-visit interaction, as well as the continuous fixed covariates of baseline, and baseline-by-visit interaction. The study identifier is also a categorical covariate for the twin studies analyses.||0.109|-0.116|0.9512
72399984|NCT02337907|144307833|SUPERIORITY|H0: The dose group with the peak response in the respective model Mean NTB response = Mean NTB response of placebo.|Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|0.056||0.9321|TWO_SIDED|95.0|-0.105|0.115||p-value was nominal and not adjusted.|Mixed Model Repeated Measurement (MMRM)|Kenward-Roger was used to model degrees of freedom.|The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|Mixed Model Repeated Measurement (MMRM) includes fixed, categorical effects of treatment, visit, current Acetylcholine Esterase Inhibitor (AChEI) use (Yes, No), and treatment-by-visit interaction, as well as the continuous fixed covariates of baseline, and baseline-by-visit interaction. The study identifier is also a categorical covariate for the twin studies analyses.||0.115|-0.105|0.9321
72399985|NCT02337907|144307833|SUPERIORITY|H0: The dose group with the peak response in the respective model Mean NTB response = Mean NTB response of placebo.|Mean Difference (Final Values)|-0.09|STANDARD_ERROR_OF_MEAN|0.057||0.1288|TWO_SIDED|95.0|-0.199|0.025||p-value was nominal and not adjusted.|Mixed Model Repeated Measurement (MMRM)|Kenward-Roger was used to model degrees of freedom.|The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences|Mixed Model Repeated Measurement (MMRM) includes fixed, categorical effects of treatment, visit, current Acetylcholine Esterase Inhibitor (AChEI) use (Yes, No), and treatment-by-visit interaction, as well as the continuous fixed covariates of baseline, and baseline-by-visit interaction. The study identifier is also a categorical covariate for the twin studies analyses.||0.025|-0.199|0.1288
72478520|NCT00577473|144482769|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.1091||||0.0769|TWO_SIDED|95.0|-1.1|22.91|||Chi-squared|||It was assumed that the true rate of improvement for the 2.4 g/day treatment group is 40% and for the 4.8 g/day group is 60%. To detect a true difference of 20% between these 2 groups with a 2-sided test, type I error of 0.05 (α = 0.05), and power of 90%, 140 patients were required per group to complete the study. To account for a 10% dropout/withdrawal rate, approximately 308 patients were to be enrolled in the study.||22.91|-1.10|0.0769
72478521|NCT00577473|144482770|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.1139||||0.0551|TWO_SIDED|95.0|-0.13|22.92|||Chi-squared|||It was assumed that the true rate of improvement for the 2.4 g/day treatment group is 40% and for the 4.8 g/day group is 60%. To detect a true difference of 20% between these 2 groups with a 2-sided test, type I error of 0.05 (α = 0.05), and power of 90%, 140 patients were required per group to complete the study. To account for a 10% dropout/withdrawal rate, approximately 308 patients were to be enrolled in the study.||22.92|-0.13|0.0551
72478522|NCT00577473|144482771|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.0738||||0.2306|TWO_SIDED|95.0|-4.66|19.43|||Chi-squared|||It was assumed that the true rate of improvement for the 2.4 g/day treatment group is 40% and for the 4.8 g/day group is 60%. To detect a true difference of 20% between these 2 groups with a 2-sided test, type I error of 0.05 (α = 0.05), and power of 90%, 140 patients were required per group to complete the study. To account for a 10% dropout/withdrawal rate, approximately 308 patients were to be enrolled in the study.||19.43|-4.66|0.2306
72509065|NCT05070429|144548458|SUPERIORITY||Maximum likelihood (MLE)|-0.011||||0.87|TWO_SIDED|95.0|-0.147|0.125|||generalized linear model (GLM)||To account for the non-normal distribution of the outcome, confidence intervals and p-values were obtained using a bias corrected and accelerated bootstrap resampling procedure with 10,000 replicates.|Used a weighted regression model with an identity link to compare treatment satisfaction at one-year post-randomization between participants assigned to the telehealth HHC or conventional HHC. Inverse probability of treatment weights will be calculated and included in the model for the secondary outcome.||0.125|-0.147|0.87
72509066|NCT05070429|144548459|SUPERIORITY||Maximum likelihood (MLE)|0.059||||0.66|TWO_SIDED|95.0|-0.201|0.32|||generalized linear model (GLM)||To account for the non-normal distribution of the outcome, confidence intervals and p-values were obtained using a bias corrected and accelerated bootstrap resampling procedure with 10,000 replicates.|Used a weighted regression model with an identity link to compare primary COSI goal achievement at one-year post-randomization between participants assigned to the telehealth HHC or conventional HHC. Inverse probability of treatment weights will be calculated and included in the model for the secondary outcome.||0.320|-0.201|0.66
72478523|NCT00577473|144482772|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.0652||||0.2931|TWO_SIDED|95.0|-5.6|18.64|||Chi-squared|||It was assumed that the true rate of improvement for the 2.4 g/day treatment group is 40% and for the 4.8 g/day group is 60%. To detect a true difference of 20% between these 2 groups with a 2-sided test, type I error of 0.05 (α = 0.05), and power of 90%, 140 patients were required per group to complete the study. To account for a 10% dropout/withdrawal rate, approximately 308 patients were to be enrolled in the study.||18.64|-5.60|0.2931
72566470|NCT02697773|144663278|SUPERIORITY||Least Square Mean Difference|-0.85|STANDARD_ERROR_OF_MEAN|0.26||0.0011|TWO_SIDED|95.0|-1.36|-0.34|||ANCOVA|||Week 12: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.||-0.34|-1.36|0.0011
72566471|NCT02697773|144663278|SUPERIORITY||Least Square Mean Difference|-0.97|STANDARD_ERROR_OF_MEAN|0.26||0.0002|TWO_SIDED|95.0|-1.48|-0.46|||ANCOVA|||Week 12: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.||-0.46|-1.48|0.0002
72623435|NCT02301897|144777753|SUPERIORITY|||||||0.0719|||||||Chi-Square Test|||||||0.0719
72623436|NCT02301897|144777753|SUPERIORITY|||||||0.0004|||||||Chi-Square Test|||||||0.0004
72399986|NCT02337907|144307833|SUPERIORITY|H1-0: Mean NTB response of pooled doses of 10 mg QD, 25 mg QD, 25 mg BID and 50 mg QD = Mean NTB response of placebo.|Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.041||0.6492|TWO_SIDED|95.0|-0.098|0.061||p-value was nominal and not adjusted.|Mixed Model Repeated Measurement (MMRM)|Kenward-Roger was used to model degrees of freedom.|The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences|Mixed Model Repeated Measurement (MMRM) includes fixed, categorical effects of treatment, visit, current Acetylcholine Esterase Inhibitor (AChEI) use (Yes, No), and treatment-by-visit interaction, as well as the continuous fixed covariates of baseline, and baseline-by-visit interaction. The study identifier is also a categorical covariate for the twin studies analyses.||0.061|-0.098|0.6492
72399987|NCT02337907|144307834|SUPERIORITY|Analyses of covariance (ANCOVA) were used to assess between-group differences in the modelled changes from baseline to Week 12.|Mean Difference (Final Values)|0.67|STANDARD_ERROR_OF_MEAN|1.066||0.5287|TWO_SIDED|95.0|-1.43|2.77||p-value was nominal and not adjusted.|ANCOVA||The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|The dependent variable was the change from the baseline score at Week 12. The model included fixed, categorical covariates of treatment as well as fixed continuous covariates of baseline score.||2.77|-1.43|0.5287
72399988|NCT02337907|144307834|SUPERIORITY|Analyses of covariance (ANCOVA) were used to assess between-group differences in the modelled changes from baseline to Week 12.|Mean Difference (Final Values)|-0.41|STANDARD_ERROR_OF_MEAN|1.099||0.7105|TWO_SIDED|95.0|-2.57|1.76||p-value was nominal and not adjusted.|ANCOVA||The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|The dependent variable was the change from the baseline score at Week 12. The model included fixed, categorical covariates of treatment as well as fixed continuous covariates of baseline score.||1.76|-2.57|0.7105
72399989|NCT02337907|144307834|SUPERIORITY|Analyses of covariance (ANCOVA) were used to assess between-group differences in the modelled changes from baseline to Week 12.|Mean Difference (Final Values)|0.93|STANDARD_ERROR_OF_MEAN|1.064||0.3822|TWO_SIDED|95.0|-1.16|3.03||p-value was nominal and not adjusted.|ANCOVA||The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|The dependent variable was the change from the baseline score at Week 12. The model included fixed, categorical covariates of treatment as well as fixed continuous covariates of baseline score.||3.03|-1.16|0.3822
72478524|NCT00577473|144482773|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.0051||||0.9349|TWO_SIDED|95.0|-11.67|12.69|||Chi-squared|||It was assumed that the true rate of improvement for the 2.4 g/day treatment group is 40% and for the 4.8 g/day group is 60%. To detect a true difference of 20% between these 2 groups with a 2-sided test, type I error of 0.05 (α = 0.05), and power of 90%, 140 patients were required per group to complete the study. To account for a 10% dropout/withdrawal rate, approximately 308 patients were to be enrolled in the study.||12.69|-11.67|0.9349
72509067|NCT05070429|144548460|SUPERIORITY||Maximum likelihood (MLE)|-1.96||||0.38|TWO_SIDED|95.0|-6.349|2.435|||generalized linear model (GLM)||To account for the non-normal distribution of the outcome, confidence intervals and p-values were obtained using a bias corrected and accelerated bootstrap resampling procedure with 10,000 replicates.|Used a weighted regression model with an identity link to compare hearing-specific quality of life at one-year post-randomization between participants assigned to the telehealth HHC or conventional HHC. Inverse probability of treatment weights will be calculated and included in the model for the secondary outcome.||2.435|-6.349|0.38
72509068|NCT00943319|144548470|OTHER||Median Survival time|161.0|||||TWO_SIDED|95.0|121.0|305.0|||Product limit survival estimate|||||305|121|
72509069|NCT00943319|144548471|OTHER||Median Disease Free Survival Time|172.0|||||TWO_SIDED|95.0|85.0|436.0||||||Estimated median survival time||436|85|
72509070|NCT02043301|144548472|SUPERIORITY_OR_OTHER|Ratios (and 90% confidence intervals) were expressed as percentages.|Adjusted Geometric Means Ratio (%)|120.96|||||TWO_SIDED|90.0|101.99|143.45|||ANCOVA|ANCOVA model with treatment group as a fixed effect and log-transformed body weight as a covariate.||Thigh (Test) versus Abdomen (Reference)||143.45|101.99|
72566472|NCT02697773|144663278|SUPERIORITY||Least Square Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.25||0.0059|TWO_SIDED|95.0|-1.2|-0.2|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.||-0.20|-1.20|0.0059
72576833|NCT00261443|144680660|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.19||||0.213|TWO_SIDED|95.0|-0.49|0.11||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 8 Comparison||0.11|-0.49|0.213
72509071|NCT02043301|144548472|SUPERIORITY_OR_OTHER|Ratios (and 90% confidence intervals) were expressed as percentages.|Adjusted Geometric Means Ratio (%)|94.93|||||TWO_SIDED|90.0|80.2|112.38|||ANCOVA|ANCOVA model with treatment group as a fixed effect and log-transformed body weight as a covariate.||Upper Arm (Test) versus Abdomen (Reference)||112.38|80.20|
72509072|NCT02043301|144548473|SUPERIORITY_OR_OTHER|Ratios (and 90% confidence intervals) were expressed as percentages.|Adjusted Geometric Means Ratio (%)|127.65|||||TWO_SIDED|90.0|107.19|152.02|||ANCOVA|ANCOVA model with treatment group as a fixed effect and log-transformed body weight as a covariate.||Thigh (Test) versus Abdomen (Reference)||152.02|107.19|
72509073|NCT02043301|144548473|SUPERIORITY_OR_OTHER|Ratios (and 90% confidence intervals) were expressed as percentages.|Adjusted Geometric Means Ratio (%)|86.16|||||TWO_SIDED|90.0|72.49|102.4|||ANCOVA|ANCOVA model with treatment group as a fixed effect and log-transformed body weight as a covariate.||Upper Arm (Test) versus Abdomen (Reference)||102.40|72.49|
72509074|NCT02043301|144548474|SUPERIORITY_OR_OTHER|Ratios (and 90% confidence intervals) were expressed as percentages.|Adjusted Geometric Means Ratio (%)|129.98|||||TWO_SIDED|90.0|106.76|158.27|||ANCOVA|ANCOVA model with treatment group as a fixed effect and log-transformed body weight as a covariate.||Thigh (Test) versus Abdomen (Reference)||158.27|106.76|
72509075|NCT02043301|144548474|SUPERIORITY_OR_OTHER|Ratios (and 90% confidence intervals) were expressed as percentages.|Adjusted Geometric Means Ratio (%)|100.27|||||TWO_SIDED|90.0|82.54|121.82|||ANCOVA|ANCOVA model with treatment group as a fixed effect and log-transformed body weight as a covariate.||Upper Arm (Test) versus Abdomen (Reference)||121.82|82.54|
72399990|NCT02337907|144307834|SUPERIORITY|Analyses of covariance (ANCOVA) were used to assess between-group differences in the modelled changes from baseline to Week 12.|Mean Difference (Final Values)|-0.49|STANDARD_ERROR_OF_MEAN|1.066||0.6472|TWO_SIDED|95.0|-2.59|1.61||p-value was nominal and not adjusted.|ANCOVA||The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|The dependent variable was the change from the baseline score at Week 12. The model included fixed, categorical covariates of treatment as well as fixed continuous covariates of baseline score.||1.61|-2.59|0.6472
72399991|NCT02337907|144307835|SUPERIORITY||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.28||0.7551|TWO_SIDED|95.0|-0.46|0.64||p-value was nominal and not adjusted.|Mixed-effects Model for Repeated Measure|Kenward-Roger was used to model degrees of freedom.|The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|Mixed Model Repeated Measurement (MMRM) includes fixed, categorical effects of treatment, visit, current Acetylcholine Esterase Inhibitor (AChEI) use (Yes, No), and treatment-by-visit interaction, as well as the continuous fixed covariates of baseline, and baseline-by-visit interaction.||0.64|-0.46|0.7551
72399992|NCT02337907|144307835|SUPERIORITY||Mean Difference (Final Values)|0.3|STANDARD_ERROR_OF_MEAN|0.28||0.3643|TWO_SIDED|95.0|-0.29|0.8||p-value was nominal and not adjusted.|Mixed-effects Model for Repeated Measure|Kenward-Roger was used to model degrees of freedom.|The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|Mixed Model Repeated Measurement (MMRM) includes fixed, categorical effects of treatment, visit, current Acetylcholine Esterase Inhibitor (AChEI) use (Yes, No), and treatment-by-visit interaction, as well as the continuous fixed covariates of baseline, and baseline-by-visit interaction.||0.80|-0.29|0.3643
72478525|NCT00577473|144482774|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.065||||0.2583|TWO_SIDED|95.0|-4.72|17.73|||Chi-squared|||It was assumed that the true rate of improvement for the 2.4 g/day treatment group is 40% and for the 4.8 g/day group is 60%. To detect a true difference of 20% between these 2 groups with a 2-sided test, type I error of 0.05 (α = 0.05), and power of 90%, 140 patients were required per group to complete the study. To account for a 10% dropout/withdrawal rate, approximately 308 patients were to be enrolled in the study.||17.73|-4.72|0.2583
72478526|NCT00968227|144482833|SUPERIORITY|Paired t-test||||||0.001|||||||t-test, 2 sided|||||||0.001
72478527|NCT01856868|144482835|EQUIVALENCE|Difference in baseline and 8 week scores was evaluated using a paired t-test analysis.||||||0.0434|||||||t-test, 2 sided|||||||0.0434
72478528|NCT01856868|144482836|EQUIVALENCE|Difference in baseline and 8 week scores was evaluated using a paired t-test analysis.||||||0.0185|||||||t-test, 2 sided|||||||0.0185
72509076|NCT02043301|144548479|SUPERIORITY_OR_OTHER|Ratios (and 90% confidence intervals) were expressed as percentages.|Adjusted Geometric Means Ratio (%)|97.35|||||TWO_SIDED|90.0|84.659|111.943|||ANCOVA|ANCOVA model with treatment group as a fixed effect and log-transformed baseline LDL-C as a covariate.||||111.943|84.659|
72509077|NCT02043301|144548479|SUPERIORITY_OR_OTHER|Ratios (and 90% confidence intervals) were expressed as percentages.|Adjusted Geometric Means Ratio (%)|103.96|||||TWO_SIDED|90.0|90.405|119.557|||ANCOVA|ANCOVA model with treatment group as a fixed effect and log-transformed baseline LDL-C as a covariate.||||119.557|90.405|
72623437|NCT02301897|144777754|SUPERIORITY|||||||0.0167|||||||Wilcoxon Rank-Sum Test|||CFB to Week 18 Course 1||||0.0167
72478529|NCT01856868|144482837|EQUIVALENCE|Difference in baseline and 8 week scores was evaluated using a paired t-test analysis.||||||0.0434|||||||t-test, 2 sided|||||||0.0434
72478530|NCT01856868|144482838|EQUIVALENCE|Difference in baseline and 8 week scores was evaluated using a paired t-test analysis.||||||0.0078|||||||t-test, 2 sided|||||||0.0078
72509078|NCT02043301|144548480|SUPERIORITY_OR_OTHER|Ratios (and 90% confidence intervals) were expressed as percentages.|Adjusted Geometric Means Ratio (%)|97.1|||||TWO_SIDED|90.0|86.558|108.926|||ANCOVA|ANCOVA model with treatment group as a fixed effect and log-transformed baseline LDL-C as a covariate.||||108.926|86.558|
72509079|NCT02043301|144548480|SUPERIORITY_OR_OTHER|Ratios (and 90% confidence intervals) were expressed as percentages.|Adjusted Geometric Means Ratio (%)|93.52|||||TWO_SIDED|90.0|83.359|104.912|||ANCOVA|ANCOVA model with treatment group as a fixed effect and log-transformed baseline LDL-C as a covariate.||||104.912|83.359|
72478531|NCT01856868|144482839|EQUIVALENCE|Difference in baseline and 8 week scores was evaluated using a paired t-test analysis.||||||0.0025|||||||t-test, 2 sided|||||||0.0025
72478532|NCT01856868|144482840|EQUIVALENCE|Difference in baseline and 8 week scores was evaluated using a paired t-test analysis.||||||0.0082|||||||t-test, 2 sided|||||||0.0082
72478533|NCT01856868|144482841|EQUIVALENCE|Difference in baseline and 8 week scores was evaluated using a paired t-test analysis.||||||0.031|||||||t-test, 2 sided|||||||0.031
72509080|NCT02043301|144548481|SUPERIORITY_OR_OTHER|Ratios (and 90% confidence intervals) were expressed as percentages.|Adjusted Geometric Means Ratio (%)|97.1|||||TWO_SIDED|90.0|86.558|108.926|||ANCOVA|ANCOVA model with treatment group as a fixed effect and log-transformed baseline LDL-C as a covariate.||||108.926|86.558|
72623438|NCT02301897|144777754|SUPERIORITY|||||||0.1257|||||||Wilcoxon Rank-Sum Test|||CFB to Week 18 Course 1||||0.1257
72623439|NCT02301897|144777754|SUPERIORITY|||||||0.9754|||||||Wilcoxon Rank-Sum Test|||CFB to ODI Course 1||||0.9754
72623440|NCT02301897|144777754|SUPERIORITY|||||||0.7672|||||||Wilcoxon Rank-Sum Test|||CFB to ODI Course 1||||0.7672
72623441|NCT02301897|144777754|SUPERIORITY|||||||0.2232|||||||Wilcoxon Rank-Sum Test|||CFB to Week 18 Course 2||||0.2232
72478534|NCT01856868|144482842|EQUIVALENCE|Difference in baseline and 8 week scores was evaluated using a paired t-test analysis.||||||0.0238|||||||Wilcoxon (Mann-Whitney)|||||||0.0238
72478535|NCT01856868|144482843|EQUIVALENCE|Difference in baseline and 8 week scores was evaluated using a paired t-test analysis.||||||0.0321|||||||t-test, 2 sided|||||||0.0321
72478536|NCT01856868|144482844|EQUIVALENCE|Difference in baseline and 8 week scores was evaluated using a paired t-test analysis.||||||0.0182|||||||t-test, 2 sided|||||||0.0182
72478537|NCT01856868|144482845|EQUIVALENCE|Difference in baseline and 8 week scores was evaluated using a paired t-test analysis.||||||0.0371|||||||t-test, 2 sided|||||||0.0371
72478538|NCT01856868|144482846|EQUIVALENCE|Difference in baseline and 8 week scores was evaluated using a paired t-test analysis.||||||0.0257|||||||t-test, 2 sided|||||||0.0257
72478539|NCT01856868|144482849|EQUIVALENCE|Difference in baseline and 8 week scores was evaluated using a mixed model regression analysis, including fixed effects for height and weight using patient identity as source of random variation. As a pilot study, these measures were not subject to a formal power analysis but will be used in future sample size calculations.|Mean Difference (Net)|-1.82|STANDARD_ERROR_OF_MEAN|2.51||0.47|TWO_SIDED||||||Mixed Models Analysis|||||||0.47
72399993|NCT02337907|144307835|SUPERIORITY||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.27||0.7822|TWO_SIDED|95.0|-0.45|0.6||p-value was nominal and not adjusted.|Mixed-effects Model for Repeated Measure|Kenward-Roger was used to model degrees of freedom.|The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|Mixed Model Repeated Measurement (MMRM) includes fixed, categorical effects of treatment, visit, current Acetylcholine Esterase Inhibitor (AChEI) use (Yes, No), and treatment-by-visit interaction, as well as the continuous fixed covariates of baseline, and baseline-by-visit interaction.||0.60|-0.45|0.7822
72399994|NCT02337907|144307835|SUPERIORITY||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.28||0.6889|TWO_SIDED|95.0|-0.43|0.65||p-value was nominal and not adjusted.|Mixed-effects Model for Repeated Measure|Kenward-Roger was used to model degrees of freedom.|The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|Mixed Model Repeated Measurement (MMRM) includes fixed, categorical effects of treatment, visit, current Acetylcholine Esterase Inhibitor (AChEI) use (Yes, No), and treatment-by-visit interaction, as well as the continuous fixed covariates of baseline, and baseline-by-visit interaction.||0.65|-0.43|0.6889
72399995|NCT02337907|144307836|SUPERIORITY|Analyses of covariance (ANCOVA) were used to assess between-group differences in the modelled changes from baseline to Week 12.|Mean Difference (Final Values)|1.32|STANDARD_ERROR_OF_MEAN|0.933||0.1595|TWO_SIDED|95.0|-0.52|3.15||p-value was nominal and not adjusted.|ANCOVA||The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|The dependent variable was the change from the baseline score at Week 12. The model included fixed, categorical covariates of treatment as well as fixed continuous covariates of baseline score.||3.15|-0.52|0.1595
72399996|NCT02337907|144307836|SUPERIORITY|Analyses of covariance (ANCOVA) were used to assess between-group differences in the modelled changes from baseline to Week 12.|Mean Difference (Final Values)|1.12|STANDARD_ERROR_OF_MEAN|0.962||0.2455|TWO_SIDED|95.0|-0.77|3.01||p-value was nominal and not adjusted.|ANCOVA||The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|The dependent variable was the change from the baseline score at Week 12. The model included fixed, categorical covariates of treatment as well as fixed continuous covariates of baseline score.||3.01|-0.77|0.2455
72399997|NCT02337907|144307836|SUPERIORITY|Analyses of covariance (ANCOVA) were used to assess between-group differences in the modelled changes from baseline to Week 12.|Mean Difference (Final Values)|1.28|STANDARD_ERROR_OF_MEAN|0.94||0.1732|TWO_SIDED|95.0|-0.57|3.13||p-value was nominal and not adjusted.|ANCOVA||The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|The dependent variable was the change from the baseline score at Week 12. The model included fixed, categorical covariates of treatment as well as fixed continuous covariates of baseline score.||3.13|-0.57|0.1732
72399998|NCT02337907|144307836|SUPERIORITY|Analyses of covariance (ANCOVA) were used to assess between-group differences in the modelled changes from baseline to Week 12.|Mean Difference (Final Values)|2.47|STANDARD_ERROR_OF_MEAN|0.936||0.0088|TWO_SIDED|95.0|0.63|4.31||p-value was nominal and not adjusted.|ANCOVA||The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|The dependent variable was the change from the baseline score at Week 12. The model included fixed, categorical covariates of treatment as well as fixed continuous covariates of baseline score.||4.31|0.63|0.0088
72478540|NCT01856868|144482850|EQUIVALENCE|Difference in baseline and 8 week scores was evaluated using a mixed model regression analysis, including fixed effects for height, weight and knee extension strength using patient identity as source of random variation. As a pilot study, these measures were not subject to a formal power analysis but will be used in future sample size calculations.|Mean Difference (Net)|11.2|STANDARD_ERROR_OF_MEAN|16.6||0.5|TWO_SIDED||||||Mixed Models Analysis|||||||0.50
72478541|NCT01856868|144482852|EQUIVALENCE|Difference in baseline and 8 week scores was evaluated using a mixed model regression analysis, including fixed effects for height, weight and knee extension strength using patient identity as source of random variation. As a pilot study, these measures were not subject to a formal power analysis but will be used in future sample size calculations.|Mean Difference (Net)|5.33|STANDARD_ERROR_OF_MEAN|3.79||0.159|TWO_SIDED||||||Mixed Models Analysis|||||||0.159
72478542|NCT00986973|144482855|SUPERIORITY_OR_OTHER||||||>|0.05|ONE_SIDED||||||t-test, 2 sided|||||||>0.05
72509081|NCT02043301|144548481|SUPERIORITY_OR_OTHER|Ratios (and 90% confidence intervals) were expressed as percentages.|Adjusted Geometric Means Ratio (%)|93.52|||||TWO_SIDED|90.0|83.359|104.912|||ANCOVA|ANCOVA model with treatment group as a fixed effect and log-transformed baseline LDL-C as a covariate.||||104.912|83.359|
72509082|NCT02043301|144548483|SUPERIORITY_OR_OTHER|Ratios (and 90% confidence intervals) were expressed as percentages.|Adjusted Geometric Means Ratio (%)|102.51|||||TWO_SIDED|90.0|97.555|107.717|||ANCOVA|ANCOVA model with treatment group as a fixed effect and log-transformed baseline LDL-C as a covariate.||||107.717|97.555|
72623442|NCT02301897|144777754|SUPERIORITY|||||||0.4512|||||||Wilcoxon Rank-Sum Test|||CFB to Week 18 Course 2||||0.4512
72399999|NCT01519414|144307865|OTHER|||||||0.02|||||||Log Rank|||||||0.02
72509083|NCT02043301|144548483|SUPERIORITY_OR_OTHER|Ratios (and 90% confidence intervals) were expressed as percentages.|Adjusted Geometric Means Ratio (%)|102.02|||||TWO_SIDED|90.0|97.131|107.151|||ANCOVA|ANCOVA model with treatment group as a fixed effect and log-transformed baseline LDL-C as a covariate.||||107.151|97.131|
72400000|NCT03255382|144307896|OTHER||Adjusted percentage difference|73.3|||<|0.001|TWO_SIDED|95.0|61.3|85.3|||Cochran-Mantel-Haenszel|||P-value was calculated from the Cochran-Mantel-Haenszel (CMH) test adjusted for strata (prior phototherapy \[yes/no\]).||85.3|61.3|< 0.001
72400001|NCT03255382|144307897|OTHER||Adjusted percentage difference|46.8|||<|0.001|TWO_SIDED|95.0|32.8|60.8|||Cochran-Mantel-Haenszel|||P-value was calculated from the CMH test adjusted for strata (prior phototherapy \[yes/no\]).||60.8|32.8|< 0.001
72400002|NCT03255382|144307898|OTHER||Adjusted percentage difference|63.4|||<|0.001|TWO_SIDED|95.0|50.2|76.6|||Cochran-Mantel-Haenszel|||P-value was calculated from the CMH test adjusted for strata (prior phototherapy \[yes/no\]).||76.6|50.2|< 0.001
72400003|NCT03255382|144307899|OTHER||Adjusted percentage difference|53.1|||<|0.001|TWO_SIDED|95.0|40.4|65.7|||Cochran-Mantel-Haenszel|||P-value was calculated from the CMH test adjusted for strata (prior phototherapy \[yes/no\]).||65.7|40.4|< 0.001
72400004|NCT03255382|144307900|OTHER||Adjusted percentage difference|39.6|||<|0.001|TWO_SIDED|95.0|27.3|51.9|||Cochran-Mantel-Haenszel|||P-value was calculated from the CMH test adjusted for strata (prior phototherapy \[yes/no\]).||51.9|27.3|< 0.001
72400005|NCT03255382|144307901|OTHER||Adjusted percentage difference|36.3|||<|0.001|TWO_SIDED|95.0|24.1|48.5|||Cochran-Mantel-Haenszel|||P-value was calculated from the CMH test adjusted for strata (prior phototherapy \[yes/no\]).||48.5|24.1|< 0.001
72400006|NCT03255382|144307902|OTHER||Adjusted percentage difference|46.4|||<|0.001|TWO_SIDED|95.0|33.7|59.0|||Cochran-Mantel-Haenszel|||P-value was calculated from the CMH test adjusted for strata (prior phototherapy \[yes/no\]).||59.0|33.7|< 0.001
72400007|NCT03255382|144307903|OTHER||Adjusted percentage difference|9.9||||0.047|TWO_SIDED|95.0|0.1|19.7|||Cochran-Mantel-Haenszel|||P-value was calculated from the CMH test adjusted for strata (prior phototherapy \[yes/no\]).||19.7|0.1|0.047
72400008|NCT03255382|144307904|OTHER||Adjusted percentage difference|66.6|||<|0.001|TWO_SIDED|95.0|53.8|79.5|||Cochran-Mantel-Haenszel|||P-value was calculated from the CMH test adjusted for strata (prior phototherapy \[yes/no\]).||79.5|53.8|< 0.001
72400009|NCT03255382|144307905|OTHER||Adjusted percentage difference|66.6|||<|0.001|TWO_SIDED|95.0|53.3|79.9|||Cochran-Mantel-Haenszel|||P-value was calculated from the CMH test adjusted for strata (prior phototherapy \[yes/no\]).||79.9|53.3|< 0.001
72400010|NCT03255382|144307906|OTHER||Adjusted percentage difference|66.6|||<|0.001|TWO_SIDED|95.0|53.8|79.5|||Cochran-Mantel-Haenszel|||P-value was calculated from the CMH test adjusted for strata (prior phototherapy \[yes/no\]).||79.5|53.8|< 0.001
72478543|NCT00986973|144482856|SUPERIORITY_OR_OTHER|||||||0.82|TWO_SIDED||||||Friedman test|Non-parametric test was used to examine neuropsychological outcomes||||||0.82
72400011|NCT03255382|144307907|OTHER||Adjusted percentage difference|56.5|||<|0.001|TWO_SIDED|95.0|43.0|70.0|||Cochran-Mantel-Haenszel|||P-value was calculated from the CMH test adjusted for strata (prior phototherapy \[yes/no\]).||70.0|43.0|< 0.001
72400012|NCT03255382|144307908|OTHER||Adjusted percentage difference|64.8|||<|0.001|TWO_SIDED|95.0|52.5|77.2|||Cochran-Mantel-Haenszel|||P-value was calculated from the CMH test adjusted for strata (prior phototherapy \[yes/no\]).||77.2|52.5|< 0.001
72478544|NCT00986973|144482857|SUPERIORITY_OR_OTHER|||||||0.46|TWO_SIDED||||||Friedman test|Non-parametric test was used to examine neuropsychological outcomes||||||0.46
72478545|NCT00986973|144482858|SUPERIORITY_OR_OTHER|||||||0.071|TWO_SIDED||||||Friedman test|Non-parametric test was used to examine neuropsychological outcomes||||||0.071
72509084|NCT02043301|144548484|SUPERIORITY_OR_OTHER|Ratios (and 90% confidence intervals) were expressed as percentages.|Adjusted Geometric Means Ratio (%)|79.09|||||TWO_SIDED|90.0|60.883|102.735|||ANCOVA|ANCOVA model with treatment group as a fixed effect and log-transformed baseline LDL-C as a covariate.||||102.735|60.883|
72509085|NCT02043301|144548484|SUPERIORITY_OR_OTHER|Ratios (and 90% confidence intervals) were expressed as percentages.|Adjusted Geometric Means Ratio (%)|91.15|||||TWO_SIDED|90.0|70.269|118.248|||ANCOVA|ANCOVA model with treatment group as a fixed effect and log-transformed baseline LDL-C as a covariate.||||118.248|70.269|
72400013|NCT03255382|144307909|OTHER||Adjusted percentage difference|1.7||||0.392|TWO_SIDED|95.0|-2.1|5.4|||Cochran-Mantel-Haenszel|||P-value was calculated from the CMH test adjusted for strata (prior phototherapy \[yes/no\]).||5.4|-2.1|0.392
72478546|NCT00986973|144482859|SUPERIORITY_OR_OTHER|||||||0.25|TWO_SIDED||||||Friedman test|Non-parametric test was used to examine neuropsychological outcomes||||||0.25
72509086|NCT02043301|144548485|SUPERIORITY_OR_OTHER|Ratios (and 90% confidence intervals) were expressed as percentages.|Adjusted Geometric Means Ratio (%)|79.09|||||TWO_SIDED|90.0|60.883|102.735|||ANCOVA|ANCOVA model with treatment group as a fixed effect and log-transformed baseline LDL-C as a covariate.||||102.735|60.883|
72509087|NCT02043301|144548485|SUPERIORITY_OR_OTHER|Ratios (and 90% confidence intervals) were expressed as percentages.|Adjusted Geometric Means Ratio (%)|91.15|||||TWO_SIDED|90.0|70.269|118.248|||ANCOVA|ANCOVA model with treatment group as a fixed effect and log-transformed baseline LDL-C as a covariate.||||118.248|70.269|
72566473|NCT02697773|144663278|SUPERIORITY||Least Square Mean Difference|-0.89|STANDARD_ERROR_OF_MEAN|0.25||0.0005|TWO_SIDED|95.0|-1.39|-0.39|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.||-0.39|-1.39|0.0005
72566474|NCT02697773|144663281|SUPERIORITY||Least Square Mean Difference|0.61|STANDARD_ERROR_OF_MEAN|1.56||0.6984|TWO_SIDED|95.0|-2.48|3.7|||ANCOVA|||Percent Work Time Missed: WPAI parameters were analyzed using ANCOVA model which included covariates of the corresponding baseline score, baseline diary average pain, index joint, highest Kellgren-Lawrence grade (2, 3 or 4), and treatment, with study site as a random effect.||3.70|-2.48|0.6984
72400014|NCT03255382|144307910|OTHER||Adjusted percentage difference|36.6|||<|0.001|TWO_SIDED|95.0|23.8|49.3|||Cochran-Mantel-Haenszel|||P-value was calculated from the CMH test adjusted for strata (prior phototherapy \[yes/no\]).||49.3|23.8|< 0.001
72400015|NCT03255382|144307911|OTHER||Adjusted percentage difference|56.6|||<|0.001|TWO_SIDED|95.0|43.2|70.0|||Cochran-Mantel-Haenszel|||P-value was calculated from the CMH test adjusted for strata (prior phototherapy \[yes/no\]).||70.0|43.2|< 0.001
72400016|NCT03255382|144307912|OTHER||Adjusted percentage difference|64.9|||<|0.001|TWO_SIDED|95.0|51.5|78.3|||Cochran-Mantel-Haenszel|||P-value was calculated from the CMH test adjusted for strata (prior phototherapy \[yes/no\]).||78.3|51.5|< 0.001
72400017|NCT03255382|144307913|OTHER||Adjusted percentage difference|66.6|||<|0.001|TWO_SIDED|95.0|53.3|79.8|||Cochran-Mantel-Haenszel|||P-value was calculated from the CMH test adjusted for strata (prior phototherapy \[yes/no\]).||79.8|53.3|< 0.001
72400018|NCT03255382|144307914|OTHER||Adjusted percentage difference|0.0||||0.991|TWO_SIDED|95.0|-2.0|2.1|||Cochran-Mantel-Haenszel|||P-value was calculated from the CMH test adjusted for strata (prior phototherapy \[yes/no\]).||2.1|-2.0|0.991
72400019|NCT03255382|144307915|OTHER||Adjusted percentage difference|3.3||||0.323|TWO_SIDED|95.0|-3.2|9.8|||Cochran-Mantel-Haenszel|||P-value was calculated from the CMH test adjusted for strata (prior phototherapy \[yes/no\]).||9.8|-3.2|0.323
72400020|NCT03255382|144307916|OTHER||Adjusted percentage difference|21.5|||<|0.001|TWO_SIDED|95.0|10.4|32.6|||Cochran-Mantel-Haenszel|||P-value was calculated from the CMH test adjusted for strata (prior phototherapy \[yes/no\]).||32.6|10.4|< 0.001
72400021|NCT03255382|144307917|OTHER||Adjusted percentage difference|33.1|||<|0.001|TWO_SIDED|95.0|20.7|45.5|||Cochran-Mantel-Haenszel|||P-value was calculated from the CMH test adjusted for strata (prior phototherapy \[yes/no\]).||45.5|20.7|< 0.001
72400022|NCT03255382|144307918|OTHER||Adjusted percentage difference|41.3|||<|0.001|TWO_SIDED|95.0|27.3|55.3|||Cochran-Mantel-Haenszel|||P-value was calculated from the CMH test adjusted for strata (prior phototherapy \[yes/no\]).||55.3|27.3|< 0.001
72400023|NCT03255382|144307919|OTHER||Adjusted percentage difference|44.7|||<|0.001|TWO_SIDED|95.0|30.9|58.5|||Cochran-Mantel-Haenszel|||P-value was calculated from the CMH test adjusted for strata (prior phototherapy \[yes/no\]).||58.5|30.9|< 0.001
72400024|NCT03255382|144307920|OTHER||Least Squares Mean Difference|-7.19|STANDARD_ERROR_OF_MEAN|0.825|<|0.001|TWO_SIDED|95.0|-8.82|-5.56|||ANCOVA|||P-values were calculated using ANCOVA with strata (phototherapy \[yes/no\]), baseline value, and the treatment in this model.||-5.56|-8.82|< 0.001
72478547|NCT00986973|144482860|SUPERIORITY_OR_OTHER|||||||0.05|TWO_SIDED||||||Friedman test|Non-parametric test was used to examine neuropsychological outcomes||||||0.050
72478548|NCT00986973|144482861|SUPERIORITY_OR_OTHER|||||||0.34|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.34
72478549|NCT02891408|144482939|OTHER||Geometric least-square mean (GLSM) ratio|181.0|||||TWO_SIDED|90.0|98.0|332.0||||||AUClast of Firsocostat||332|98|
72478550|NCT02891408|144482939|OTHER||GLSM ratio|881.0|||||TWO_SIDED|90.0|488.0|1589.0||||||AUClast of Firsocostat||1589|488|
72478551|NCT02891408|144482939|OTHER||GLSM ratio|3081.0|||||TWO_SIDED|90.0|2446.0|3881.0||||||AUClast of Firsocostat||3881|2446|
72509088|NCT00883558|144548510|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority of INSULIN-PH20 NP to insulin lispro was supported if the upper limit of the one-sided 95% confidence interval for the difference in blood glucose between the treatments did not exceed 21.6 mg/dL.|LS Mean Difference|3.06||||0.3217|ONE_SIDED|95.0||14.11|||Mixed Models Analysis|Adjustments included treatment, phase, and treatment sequence as fixed effects and participant within treatment sequence as a random effect.||A total of at least 40 participants were to be enrolled in the study, and 30 participants were expected to complete both treatment cycles. Assuming a standard deviation for blood glucose of 45 milligrams per deciliter (mg/dL) and a true difference between the treatments of 0 mg/dL, the study had approximately 80% power to show that INSULIN-PH20 NP was non-inferior to insulin lispro with respect to the overall two-hour postprandial blood glucose excursion.||14.11||0.3217
72509089|NCT02436577|144548513|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|93.16|||||TWO_SIDED|90.0|85.8|101.15|||ANOVA|||Statistical Assessment of Bioequivalence for Ticagrelor Following Ticagrelor OD Tablets Compared to Ticagrelor IR Tablets.||101.15|85.80|
72623443|NCT02301897|144777754|SUPERIORITY|||||||0.3545|||||||Wilcoxon Rank-Sum Test|||CFB to Course 2 Week 28 FU||||0.3545
72400025|NCT03255382|144307921|OTHER||Least Squares Mean Difference|-9.58|STANDARD_ERROR_OF_MEAN|0.936|<|0.001|TWO_SIDED|95.0|-11.43|-7.72|||ANCOVA|||P-values were calculated using ANCOVA with strata (phototherapy \[yes/no\]), baseline value, and treatment in the model.||-7.72|-11.43|< 0.001
72478552|NCT02891408|144482939|OTHER||GLSM ratio|430.0|||||TWO_SIDED|90.0|185.0|998.0||||||AUClast of GS-834773||998|185|
72478553|NCT02891408|144482939|OTHER||GLSM ratio|4417.0|||||TWO_SIDED|90.0|1867.0|10449.0||||||AUClast of GS-834773||10449|1867|
72478554|NCT02891408|144482939|OTHER||GLSM ratio|14676.0|||||TWO_SIDED|90.0|7932.0|27153.0||||||AUClast of GS-834773||27153|7932|
72478555|NCT02891408|144482939|OTHER||GLSM ratio|122.0|||||TWO_SIDED|90.0|86.0|173.0||||||AUClast of Fenofibric Acid||173|86|
72478556|NCT02891408|144482940|OTHER||GLSM ratio|183.0|||||TWO_SIDED|90.0|100.0|337.0||||||AUCinf of Firsocostat||337|100|
72478557|NCT02891408|144482940|OTHER||GLSM ratio|869.0|||||TWO_SIDED|90.0|482.0|1568.0||||||AUCinf of Firsocostat||1568|482|
72509090|NCT02436577|144548513|SUPERIORITY_OR_OTHER||Geometric mean ratio|93.67|||||TWO_SIDED|90.0|87.88|99.84|||ANOVA|||Statistical Assessment of Bioequivalence for Ticagrelor Following Ticagrelor OD Tablets Compared to Ticagrelor IR Tablets.||99.84|87.88|
72509091|NCT02436577|144548513|SUPERIORITY_OR_OTHER||Geometric mean ratio|96.79|||||TWO_SIDED|90.0|88.27|106.14|||ANOVA|||Statistical Assessment of Bioequivalence for metabolite AR-C124910XX Following Ticagrelor OD Tablets Compared to Ticagrelor IR Tablets.||106.14|88.27|
72623444|NCT02301897|144777754|SUPERIORITY|||||||0.2482|||||||Wilcoxon Rank-Sum Test|||CFB to Course 2 Week 28 FU||||0.2482
72623445|NCT02301897|144777755|SUPERIORITY|||||||0.0016|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Week 18 Course 1||||0.0016
72623446|NCT02301897|144777755|SUPERIORITY|||||||0.0003|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Week 18 Course 1||||0.0003
72623447|NCT02301897|144777755|SUPERIORITY|||||||0.6666|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to ODI Course 1||||0.6666
72478558|NCT02891408|144482940|OTHER||GLSM ratio|2976.0|||||TWO_SIDED|90.0|2389.0|3708.0||||||AUCinf of Firsocostat||3708|2389|
72478559|NCT02891408|144482940|OTHER||GLSM ratio|399.0|||||TWO_SIDED|90.0|179.0|892.0||||||AUCinf of GS-834773||892|179|
72478560|NCT02891408|144482940|OTHER||GLSM ratio|3843.0|||||TWO_SIDED|90.0|1641.0|9000.0||||||AUCinf of GS-834773||9000|1641|
72478561|NCT02891408|144482940|OTHER||GLSM ratio|10712.0|||||TWO_SIDED|90.0|6525.0|17585.0||||||AUCinf of GS-834773||17585|6525|
72478562|NCT02891408|144482940|OTHER||GLSM ratio|125.0|||||TWO_SIDED|90.0|89.0|174.0||||||AUCinf of Fenofibric Acid||174|89|
72400026|NCT03255382|144307922|OTHER||Least Squares Mean Difference|-8.8|STANDARD_ERROR_OF_MEAN|0.972|<|0.001|TWO_SIDED|95.0|-10.72|-6.87|||ANCOVA|||P-values were calculated using ANCOVA with strata (phototherapy \[yes/no\]), baseline value, and treatment in the model.||-6.87|-10.72|< 0.001
72400027|NCT03255382|144307923|OTHER||Least Squares Mean Difference|-7.78|STANDARD_ERROR_OF_MEAN|0.958|<|0.001|TWO_SIDED|95.0|-9.68|-5.88|||ANCOVA|||P-values were calculated using ANCOVA with strata (phototherapy \[yes/no\]), baseline value, and treatment in the model.||-5.88|-9.68|< 0.001
72478563|NCT02891408|144482941|OTHER||GLSM ratio|169.0|||||TWO_SIDED|90.0|87.0|326.0||||||Cmax of Firsocostat||326|87|
72478564|NCT02891408|144482941|OTHER||GLSM ratio|905.0|||||TWO_SIDED|90.0|537.0|1526.0||||||Cmax of Firsocostat||1526|537|
72478565|NCT02891408|144482941|OTHER||GLSM ratio|2719.0|||||TWO_SIDED|90.0|1994.0|3708.0||||||Cmax of Firsocostat||3708|1994|
72478566|NCT02891408|144482941|OTHER||GLSM ratio|391.0|||||TWO_SIDED|90.0|163.0|942.0||||||Cmax of GS-834773||942|163|
72478567|NCT02891408|144482941|OTHER||GLSM ratio|4470.0|||||TWO_SIDED|90.0|2170.0|9207.0||||||Cmax of GS-834773||9207|2170|
72478568|NCT02891408|144482941|OTHER||GLSM ratio|9278.0|||||TWO_SIDED|90.0|4945.0|17407.0||||||Cmax of GS-834773||17407|4945|
72478569|NCT02891408|144482941|OTHER||GLSM ratio|109.0|||||TWO_SIDED|90.0|81.0|146.0||||||Cmax of Fenofibric Acid||146|81|
72478570|NCT00709852|144482966|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.26|STANDARD_DEVIATION|0.61|<|0.0001||||||for contrast enhancement|paired t-test|||||||< 0.0001
72478571|NCT00709852|144482966|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.67|STANDARD_DEVIATION|0.66|<|0.0001||||||for border delineation|paired t-test|||||||< 0.0001
72400028|NCT03255382|144307924|OTHER||Least Squares Mean Difference|-7.89|STANDARD_ERROR_OF_MEAN|1.101|<|0.001|TWO_SIDED|95.0|-10.07|-5.71|||ANCOVA|||P-values were calculated using ANCOVA with strata (phototherapy \[yes/no\]), baseline value, and treatment in the model.||-5.71|-10.07|< 0.001
72478572|NCT00709852|144482966|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.62|STANDARD_DEVIATION|0.47|<|0.0001||||||for internal morphology|paired t-test|||||||< 0.0001
72478573|NCT00709852|144482967|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.59|STANDARD_DEVIATION|0.77|<|0.0001||||||for contrast enhancement|paired t test|||||||< 0.0001
72478574|NCT00709852|144482967|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.72|STANDARD_DEVIATION|0.78|<|0.0001||||||for border delineation|paired t test|||||||< 0.0001
72478575|NCT00709852|144482967|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.82|STANDARD_DEVIATION|0.61|<|0.0001||||||for internal morphology|paired t test|||||||< 0.0001
72478576|NCT00709852|144482968|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.06|STANDARD_DEVIATION|0.51|<|0.0001||||||for contrast enhancement|paired t test|||||||< 0.0001
72478577|NCT00709852|144482968|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.43|STANDARD_DEVIATION|0.5|<|0.0001||||||for border delineation|paired t test|||||||< 0.0001
72509092|NCT02436577|144548513|SUPERIORITY_OR_OTHER||Geometric mean ratio|92.32|||||TWO_SIDED|90.0|85.04|100.23|||ANOVA|||Statistical Assessment of Bioequivalence for metabolite AR-C124910XX Following Ticagrelor OD Tablets Compared to Ticagrelor IR Tablets.||100.23|85.04|
72623448|NCT02301897|144777755|SUPERIORITY|||||||0.3612|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to ODI Course 1||||0.3612
72623449|NCT02301897|144777755|SUPERIORITY|||||||0.0309|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Week 18 Course 2||||0.0309
72478578|NCT00709852|144482968|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.41|STANDARD_DEVIATION|0.52|<|0.0001||||||for internal morphology|paired t test|||||||< 0.0001
72478579|NCT00709852|144482969|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.29|STANDARD_DEVIATION|0.56|<|0.0001||||||for contrast enhancement|paired t test|||||||< 0.0001
72478580|NCT00709852|144482969|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.6|STANDARD_DEVIATION|0.53|<|0.0001||||||for border delineation|paired t test|||||||< 0.0001
72478581|NCT00709852|144482969|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.61|STANDARD_DEVIATION|0.42|<|0.0001||||||for internal morphology|paired t test|||||||< 0.0001
72478582|NCT00709852|144482970|NON_INFERIORITY_OR_EQUIVALENCE|noninferiority margin = -0.35|Mean Difference (Final Values)|0.39|STANDARD_DEVIATION|5.51|||TWO_SIDED|95.0|-0.199|0.984|||confidence interval for paired means|lower limit of interval is compared to noninferiority margin||BR 1||0.984|-0.199|
72478583|NCT00709852|144482970|NON_INFERIORITY_OR_EQUIVALENCE|noninferiority margin = -0.35|Mean Difference (Final Values)|-0.44|STANDARD_DEVIATION|12.38|||TWO_SIDED|95.0|-1.772|0.885|||confidence interval for paired means|lower limit of confidence interval (CI) is compared to noninferiority margin||BR 2||0.885|-1.772|
72478584|NCT00709852|144482970|NON_INFERIORITY_OR_EQUIVALENCE|noninferiority margin = -0.35|Mean Difference (Final Values)|0.56|STANDARD_DEVIATION|4.07|||TWO_SIDED|95.0|0.125|1.0|||confidence interval for paired means|lower limit of confidence interval is compared to noninferiority margin||BR 3||1.000|0.125|
72478585|NCT00709852|144482970|NON_INFERIORITY_OR_EQUIVALENCE|noninferiority margin = -0.35|Mean Difference (Final Values)|0.17|STANDARD_DEVIATION|5.68|||TWO_SIDED|95.0|-0.439|0.78|||confidence interval for paired means|lower limit of confidence interval is compared to noninferiority margin||AR||0.780|-0.439|
72478586|NCT00709852|144482971|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.62|STANDARD_DEVIATION|0.3|<|0.0001||||||for contrast enhancement|paired t test|||||||< 0.0001
72478587|NCT00709852|144482971|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.81|STANDARD_DEVIATION|0.37|<|0.0001||||||for border delineation|paired t test|||||||< 0.0001
72478588|NCT00709852|144482971|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.77|STANDARD_DEVIATION|0.38|<|0.0001||||||for internal morphology|paired t test|||||||< 0.0001
72478589|NCT00709852|144482972|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.13|STANDARD_DEVIATION|0.62|<|0.0001||||||for contrast enhancement|paired t test|||||||< 0.0001
72509093|NCT02436577|144548514|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|97.76|||||TWO_SIDED|90.0|94.46|101.18|||ANOVA|||Statistical Assessment of Bioequivalence for Ticagrelor Following Ticagrelor OD Tablets Compared to Ticagrelor IR Tablets.||101.18|94.46|
72509094|NCT02436577|144548514|SUPERIORITY_OR_OTHER||Geometric Mean ratio|96.38|||||TWO_SIDED|90.0|93.24|99.63|||ANOVA|||Statistical Assessment of Bioequivalence for Ticagrelor Following Ticagrelor OD Tablets Compared to Ticagrelor IR Tablets.||99.63|93.24|
72478590|NCT00709852|144482972|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.86|STANDARD_DEVIATION|0.46|<|0.0001||||||for border delineation|paired t test|||||||< 0.0001
72478591|NCT00709852|144482972|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.1|STANDARD_DEVIATION|0.39|<|0.0001||||||for internal morphology|paired t test|||||||< 0.0001
72478592|NCT00709852|144482973|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.36|STANDARD_DEVIATION|0.33|<|0.0001||||||for contrast enhancement|paired t test|||||||< 0.0001
72478593|NCT00709852|144482973|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.5|STANDARD_DEVIATION|0.33|<|0.0001||||||for border delineation|paired t test|||||||< 0.0001
72478594|NCT00709852|144482973|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.43|STANDARD_DEVIATION|0.32|<|0.0001||||||for internal morphology|paired t test|||||||< 0.0001
72478595|NCT00709852|144482974|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.7|STANDARD_DEVIATION|0.3|<|0.0001||||||for contrast enhancement|paired t test|||||||< 0.0001
72478596|NCT00709852|144482974|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.72|STANDARD_DEVIATION|0.23|<|0.0001||||||for border delineation|paired t test|||||||< 0.0001
72478597|NCT00709852|144482974|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.76|STANDARD_DEVIATION|0.22|<|0.0001||||||for internal morphology|paired t test|||||||< 0.0001
72478598|NCT00709852|144482975|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.83|STANDARD_DEVIATION|1.16|<|0.0001||||||for contrast enhancement|paired t test|||||||< 0.0001
72623450|NCT02301897|144777755|SUPERIORITY|||||||0.0007|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Week 18 Course 2||||0.0007
72623451|NCT02301897|144777755|SUPERIORITY|||||||0.0641|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Course 2 Week 28 FU||||0.0641
72623452|NCT02301897|144777755|SUPERIORITY|||||||0.3743|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Course 2 Week 28 FU||||0.3743
72623453|NCT02301897|144777756|SUPERIORITY|||||||0.0049|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Week 18 Course 1||||0.0049
72623454|NCT02301897|144777756|SUPERIORITY|||||||0.0064|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Week 18 Course 1||||0.0064
72478599|NCT00709852|144482975|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.52|STANDARD_DEVIATION|1.26|<|0.0001||||||for border delineation|paired t test|||||||< 0.0001
72566475|NCT02697773|144663281|SUPERIORITY||Least Square Mean Difference|-1.68|STANDARD_ERROR_OF_MEAN|1.6||0.2953|TWO_SIDED|95.0|-4.84|1.48|||ANCOVA|||Percent Work Time Missed: WPAI parameters were analyzed using ANCOVA model which included covariates of the corresponding baseline score, baseline diary average pain, index joint, highest Kellgren-Lawrence grade (2, 3 or 4), and treatment, with study site as a random effect.||1.48|-4.84|0.2953
72566476|NCT02697773|144663281|SUPERIORITY||Least Square Mean Difference|-5.43|STANDARD_ERROR_OF_MEAN|4.14||0.1911|TWO_SIDED|95.0|-13.59|2.74|||ANCOVA|||Percent Impairment While Working: WPAI parameters were analyzed using ANCOVA model which included covariates of the corresponding baseline score, baseline diary average pain, index joint, highest Kellgren-Lawrence grade (2, 3 or 4), and treatment, with study site as a random effect.||2.74|-13.59|0.1911
72566477|NCT02697773|144663281|SUPERIORITY||Least Square Mean Difference|-5.59|STANDARD_ERROR_OF_MEAN|4.2||0.1857|TWO_SIDED|95.0|-13.89|2.71|||ANCOVA|||Percent Impairment While Working: WPAI parameters were analyzed using ANCOVA model which included covariates of the corresponding baseline score, baseline diary average pain, index joint, highest Kellgren-Lawrence grade (2, 3 or 4), and treatment, with study site as a random effect.||2.71|-13.89|0.1857
72566478|NCT02697773|144663281|SUPERIORITY||Least Square Mean Difference|-5.8|STANDARD_ERROR_OF_MEAN|4.21||0.1707|TWO_SIDED|95.0|-14.12|2.52|||ANCOVA|||Percent Overall Work Impairment: WPAI parameters were analyzed using ANCOVA model which included covariates of the corresponding baseline score, baseline diary average pain, index joint, highest Kellgren-Lawrence grade (2, 3 or 4), and treatment, with study site as a random effect.||2.52|-14.12|0.1707
72623455|NCT02301897|144777756|SUPERIORITY|||||||0.5637|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to On-Drug Course 2||||0.5637
72623456|NCT02301897|144777756|SUPERIORITY|||||||0.0505|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to On-Drug Course 2||||0.0505
72623457|NCT02301897|144777756|SUPERIORITY|||||||0.4262|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Week 18 Course 2||||0.4262
72478600|NCT00709852|144482975|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.44|STANDARD_DEVIATION|0.82|<|0.0001||||||for internal morphology|paired t test|||||||< 0.0001
72478601|NCT00709852|144482976|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.89|STANDARD_DEVIATION|1.29|<|0.0001||||||for contrast enhancement|paired t test|||||||< 0.0001
72478602|NCT00709852|144482976|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.54|STANDARD_DEVIATION|1.44|<|0.0001||||||for border delineation|paired t test|||||||< 0.0001
72478603|NCT00709852|144482976|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.48|STANDARD_DEVIATION|1.11|<|0.0001||||||for internal morphology|paired t test|||||||< 0.0001
72478604|NCT00709852|144482977|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.69|STANDARD_DEVIATION|0.95|<|0.0001||||||for contrast enhancement|paired t test|||||||< 0.0001
72478605|NCT00709852|144482977|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.33|STANDARD_DEVIATION|0.97|<|0.0001||||||for border delineation|paired t test|||||||< 0.0001
72478606|NCT00709852|144482977|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.39|STANDARD_DEVIATION|0.96|<|0.0001||||||for internal morphology|paired t test|||||||< 0.0001
72478607|NCT00709852|144482978|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.78|STANDARD_DEVIATION|1.06|<|0.0001||||||for contrast enhancement|paired t test|||||||< 0.0001
72478608|NCT00709852|144482978|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.44|STANDARD_DEVIATION|1.07|<|0.0001||||||for border delineation|paired t test|||||||< 0.0001
72478609|NCT00709852|144482978|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.42|STANDARD_DEVIATION|0.83|<|0.0001||||||for internal morphology|paired t test|||||||< 0.0001
72478610|NCT00709852|144482979|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.24|STANDARD_DEVIATION|0.53|<|0.0001||||||for contrast enhancement|paired t test|||||||< 0.0001
72478611|NCT00709852|144482979|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.56|STANDARD_DEVIATION|0.48|<|0.0001||||||for border delineation|paired t test|||||||< 0.0001
72478612|NCT00709852|144482979|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.58|STANDARD_DEVIATION|0.41|<|0.0001||||||for internal morphology|paired t test|||||||< 0.0001
72478613|NCT00709852|144482980|NON_INFERIORITY_OR_EQUIVALENCE|noninferiority margin = -0.35|Mean Difference (Final Values)|0.16|STANDARD_DEVIATION|6.44|||TWO_SIDED|95.0|-0.532|0.851|||confidence interval for paired means|lower limit of confidence interval is compared to noninferiority margin||||0.851|-0.532|
72566479|NCT02697773|144663281|SUPERIORITY||Least Square Mean Difference|-6.39|STANDARD_ERROR_OF_MEAN|4.29||0.138|TWO_SIDED|95.0|-14.85|2.07|||ANCOVA|||Percent Overall Work Impairment: WPAI parameters were analyzed using ANCOVA model which included covariates of the corresponding baseline score, baseline diary average pain, index joint, highest Kellgren-Lawrence grade (2, 3 or 4), and treatment, with study site as a random effect.||2.07|-14.85|0.1380
72566480|NCT02697773|144663281|SUPERIORITY||Least Square Mean Difference|-3.82|STANDARD_ERROR_OF_MEAN|2.42||0.1151|TWO_SIDED|95.0|-8.58|0.94|||ANCOVA|||Percent Activity Impairment: WPAI parameters were analyzed using ANCOVA model which included covariates of the corresponding baseline score, baseline diary average pain, index joint, highest Kellgren-Lawrence grade (2, 3 or 4), and treatment, with study site as a random effect.||0.94|-8.58|0.1151
72566481|NCT02697773|144663281|SUPERIORITY||Least Square Mean Difference|-3.77|STANDARD_ERROR_OF_MEAN|2.41||0.1195|TWO_SIDED|95.0|-8.51|0.98|||ANCOVA|||Percent Activity Impairment: WPAI parameters were analyzed using ANCOVA model which included covariates of the corresponding baseline score, baseline diary average pain, index joint, highest Kellgren-Lawrence grade (2, 3 or 4), and treatment, with study site as a random effect.||0.98|-8.51|0.1195
72400029|NCT03255382|144307925|OTHER||Least Squares Mean Difference|-8.39|STANDARD_ERROR_OF_MEAN|1.175|<|0.001|TWO_SIDED|95.0|-10.71|-6.06|||ANCOVA|||P-values were calculated using ANCOVA with strata (phototherapy \[yes/no\]), baseline value, and treatment in the model.||-6.06|-10.71|< 0.001
72478614|NCT00709852|144482981|NON_INFERIORITY_OR_EQUIVALENCE|noninferiority margin = -0.35|Mean Difference (Final Values)|0.04|STANDARD_DEVIATION|0.33||||95.0|0.0004|0.078|||CI for paired means|lower limit of confidence interval is compared to noninferiority margin||analysis for contrast enhancement||0.078|0.0004|
72478615|NCT00709852|144482981|NON_INFERIORITY_OR_EQUIVALENCE|noninferiority margin = -0.35|Mean Difference (Final Values)|0.04|STANDARD_DEVIATION|0.41||||95.0|-0.009|0.082|||CI for paired means|lower limit of confidence interval is compared to noninferiority margin||analysis for border delineation||0.082|-0.009|
72478616|NCT00709852|144482981|NON_INFERIORITY_OR_EQUIVALENCE|noninferiority margin = -0.35|Mean Difference (Final Values)|0.03|STANDARD_DEVIATION|0.29||||95.0|-0.006|0.059|||CI for paired means|lower limit of confidence interval is compared to noninferiority margin||analysis for internal morphology||0.059|-0.006|
72478617|NCT00709852|144482982|NON_INFERIORITY_OR_EQUIVALENCE|noninferiority margin = -0.35|Mean Difference (Final Values)|0.01|STANDARD_DEVIATION|5.7||||95.0|-0.601|0.622|||confidence interval for paired means|lower limit of confidence interval is compared to noninferiority margin||||0.622|-0.601|
72509095|NCT02436577|144548514|SUPERIORITY_OR_OTHER||Geometric mean ratio|98.43|||||TWO_SIDED|90.0|94.75|102.25|||ANOVA|||Statistical assessment of metabolite AR-C124910XX relative bioavailability following ticagrelor OD tablets administered compared to ticagrelor IR tablets.||102.25|94.75|
72509096|NCT02436577|144548514|SUPERIORITY_OR_OTHER||Geometric mean ratio|95.15|||||TWO_SIDED|90.0|91.59|98.85|||ANOVA|||Statistical assessment of metabolite AR-C124910XX relative bioavailability following ticagrelor OD tablets administered compared to ticagrelor IR tablets.||98.85|91.59|
72509097|NCT02436577|144548515|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|97.75|||||TWO_SIDED|90.0|94.4|101.21|||ANOVA|||Statistical Assessment of Bioequivalence for Ticagrelor Following Ticagrelor OD Tablets Compared to Ticagrelor IR Tablets.||101.21|94.40|
72509098|NCT02436577|144548515|SUPERIORITY_OR_OTHER||Geometric mean ratio|96.5|||||TWO_SIDED|90.0|93.31|99.8|||ANOVA|||Statistical Assessment of Bioequivalence for Ticagrelor Following Ticagrelor OD Tablets Compared to Ticagrelor IR Tablets.||99.80|93.31|
72509099|NCT02436577|144548515|SUPERIORITY_OR_OTHER||Geometric mean ratio|98.46|||||TWO_SIDED|90.0|94.85|102.2|||ANOVA|||Statistical assessment of metabolite AR-C124910XX relative bioavailability following ticagrelor OD tablets administered compared to ticagrelor IR tablets.||102.20|94.85|
72623458|NCT02301897|144777756|SUPERIORITY|||||||0.1419|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Week 18 Course 2||||0.1419
72623459|NCT02301897|144777756|SUPERIORITY|||||||0.4497|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Course 2 Week 24 FU||||0.4497
72478618|NCT00709852|144482983|SUPERIORITY_OR_OTHER||Difference in percentages|8.3|||||||||||||for BR1|||||
72478619|NCT00709852|144482983|SUPERIORITY_OR_OTHER||Difference in percentages|-0.9|||||||||||||for BR2|||||
72478620|NCT00709852|144482983|SUPERIORITY_OR_OTHER||Difference in percentages|15.8|||||||||||||for BR3|||||
72509100|NCT02436577|144548515|SUPERIORITY_OR_OTHER||Geometric mean ratio|95.47|||||TWO_SIDED|90.0|91.99|99.08|||ANOVA|||Statistical assessment of metabolite AR-C124910XX relative bioavailability following ticagrelor OD tablets administered compared to ticagrelor IR tablets.||99.08|91.99|
72509101|NCT03703375|144548529|SUPERIORITY||Hazard Ratio (HR)|0.67||||0.0541|TWO_SIDED|95.0|0.41|1.09|||Stratified Cox|Stratified Cox proportional hazards model||||1.09|0.41|0.0541
72623460|NCT02301897|144777756|SUPERIORITY|||||||0.5371|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Course 2 Week 24 FU||||0.5371
72623461|NCT02301897|144777757|SUPERIORITY|||||||0.0069|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Week 18 Course 1||||0.0069
72478621|NCT00709852|144482983|NON_INFERIORITY_OR_EQUIVALENCE|noninferiority margin = -10%|Difference in percentages|8.9|||||TWO_SIDED|95.0|-0.5|18.4|||CI for paired percentages|confidence interval is given for AR; lower limit is compared to the noninferiority margin||||18.4|-0.5|
72509102|NCT03703375|144548530|SUPERIORITY||Hazard Ratio (HR)|0.56||||0.0166|TWO_SIDED|95.0|0.32|0.96|||Efron|Stratified Cox proportional hazards model||||0.96|0.32|0.0166
72509103|NCT03703375|144548531|SUPERIORITY||Hazard Ratio (HR)|0.82||||0.2139|TWO_SIDED|95.0|0.51|1.33|||Stratified Cox|Stratified Cox proportional hazards model||||1.33|0.51|0.2139
72509104|NCT01234402|144548563|OTHER||Hazard Ratio (HR)|0.691||||0.1315|TWO_SIDED|95.0|0.429|1.114|||Log Rank|||Kaplan-Meier methodology estimated median PFS||1.114|0.429|0.1315
72509105|NCT01234402|144548563|OTHER||Hazard Ratio (HR)|1.48||||0.0851|TWO_SIDED|95.0|0.938|2.335|||Log Rank|||Kaplan-Meier methodology estimated median PFS||2.335|0.938|0.0851
72509106|NCT01234402|144548564|OTHER||Hazard Ratio (HR)|1.833||||0.0283|TWO_SIDED|95.0|1.06|3.169|||Log Rank|||||3.169|1.060|0.0283
72509107|NCT01234402|144548564|OTHER||Hazard Ratio (HR)|1.468||||0.155|TWO_SIDED|95.0|0.862|2.501|||Log Rank|||||2.501|0.862|0.1550
72509108|NCT01234402|144548565|OTHER|||||||0.6691|||||||Fisher Exact|||||||0.6691
72623462|NCT02301897|144777757|SUPERIORITY|||||||0.0059|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Week 18 Course 1||||0.0059
72478622|NCT00709852|144482984|NON_INFERIORITY_OR_EQUIVALENCE|noninferiority margin = -10%|Difference in percentages|3.6||||||95.0|-5.9|13.1|||CI for paired percentages|lower limit of confidence interval is compared to noninferiority margin||||13.1|-5.9|
72478623|NCT00709852|144482985|NON_INFERIORITY_OR_EQUIVALENCE|noninferiority margin = -10%|Difference in percentages|8.3||||||95.0|-0.9|17.6|||CI for paired percentages|lower limit of confidence interval is compared to noninferiority margin||||17.6|-0.9|
72478624|NCT00709852|144482986|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.74|STANDARD_DEVIATION|0.78|<|0.0001||||||for border delineation|paired t test|||||||< 0.0001
72509109|NCT01234402|144548565|OTHER|||||||0.1743|||||||Fisher Exact|||||||0.1743
72509110|NCT00385268|144548576|SUPERIORITY||Odds Ratio (OR)|1.68||||0.44|TWO_SIDED|95.0|0.55|5.14|||GEE model of repeated measures|GEE on repeated binary indicators of BE positive / negative test||||5.14|0.55|0.44
72509111|NCT02389816|144548577|SUPERIORITY||Least square (LS) mean difference|-2.66|STANDARD_ERROR_OF_MEAN|0.999||0.008|TWO_SIDED|95.0|-4.63|-0.7|||Mixed Models Analysis|Mixed Models for Repeated Measures (MMRM)||||-0.70|-4.63|0.0080
72509112|NCT02389816|144548577|SUPERIORITY||LS mean difference|-3.07|STANDARD_ERROR_OF_MEAN|1.003||0.0023|TWO_SIDED|95.0|-5.05|-1.1|||Mixed Models Analysis|Mixed Models for Repeated Measures (MMRM)||||-1.10|-5.05|0.0023
72509113|NCT02389816|144548578|SUPERIORITY||Odds Ratio (OR)|1.621||||0.0341|TWO_SIDED|95.0|1.037|2.533|||Regression, Logistic|||||2.533|1.037|0.0341
72623463|NCT02301897|144777757|SUPERIORITY|||||||0.2117|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to On-Drug Course 2||||0.2117
72623464|NCT02301897|144777757|SUPERIORITY|||||||0.0006|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to On-Drug Course 2||||0.0006
72623465|NCT02301897|144777757|SUPERIORITY|||||||0.0788|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Week 18 Course 2||||0.0788
72623466|NCT02301897|144777757|SUPERIORITY|||||||0.008|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Week 18 Course 2||||0.0080
72623467|NCT02301897|144777757|SUPERIORITY|||||||0.1516|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Course 2 Week 24 FU||||0.1516
72623468|NCT02301897|144777757|SUPERIORITY|||||||0.0565|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Course 2 Week 24 FU||||0.0565
72478625|NCT00709852|144482986|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.61|STANDARD_DEVIATION|0.61|<|0.0001||||||for internal morphology|paired t test|||||||< 0.0001
72478626|NCT00709852|144482987|NON_INFERIORITY_OR_EQUIVALENCE|noninferiority margin = -0.35|Mean Difference (Final Values)|0.29|STANDARD_DEVIATION|3.21||||95.0|-0.053|0.636|||confidence interval for paired means|lower limit of confidence interval is compared to noninferiority margin||||0.636|-0.053|
72478627|NCT00709852|144482988|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.77|STANDARD_DEVIATION|0.64|<|0.0001||||||for border delineation|paired t test|||||||< 0.0001
72478628|NCT00709852|144482988|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.64|STANDARD_DEVIATION|0.5|<|0.0001||||||for internal morphology|paired t test|||||||< 0.0001
72478629|NCT00709852|144482989|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.74|STANDARD_DEVIATION|1.26|<|0.0001||||||for border delineation|paired t test|||||||< 0.0001
72478630|NCT00709852|144482989|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.56|STANDARD_DEVIATION|0.97|<|0.0001||||||for internal morphology|paired t test|||||||< 0.0001
72509114|NCT02389816|144548578|SUPERIORITY||Odds Ratio (OR)|1.788||||0.011||95.0|1.143|2.799|||Regression, Logistic|||||2.799|1.143|0.0110
72509115|NCT02389816|144548579|SUPERIORITY||Odds Ratio (OR)|1.839||||0.0186|TWO_SIDED|95.0|1.107|3.054|||Regression, Logistic|||||3.054|1.107|0.0186
72509116|NCT02389816|144548579|SUPERIORITY||Odds Ratio (OR)|1.7||||0.0418|TWO_SIDED|95.0|1.02|2.834|||Regression, Logistic|||||2.834|1.020|0.0418
72509117|NCT02389816|144548580|SUPERIORITY||LS mean difference|-1.81|STANDARD_ERROR_OF_MEAN|0.753||0.0165|TWO_SIDED|95.0|-3.29|-0.332|||ANCOVA|||||-0.332|-3.290|0.0165
72623469|NCT02301897|144777758|SUPERIORITY|||||||0.011|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Week 18 Course 1||||0.0110
72478631|NCT00709852|144482990|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.71|STANDARD_DEVIATION|0.76|<|0.0001||||||for border delineation|paired t test|||||||< 0.0001
72478632|NCT00709852|144482990|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.58|STANDARD_DEVIATION|0.63|<|0.0001||||||for internal morphology|paired t test|||||||< 0.0001
72478633|NCT00709852|144482991|NON_INFERIORITY_OR_EQUIVALENCE|noninferiority margin = -0.35|Mean Difference (Final Values)|0.28|STANDARD_DEVIATION|3.39||||95.0|-0.087|0.641|||confidence interval for paired means|lower limit of confidence interval is compared to noninferiority margin||||0.641|-0.087|
72478634|NCT00709852|144482992|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.78|STANDARD_DEVIATION|0.61|<|0.0001||||||for border delineation|paired t test|||||||< 0.0001
72509118|NCT02389816|144548580|SUPERIORITY||LS mean difference|-1.79|STANDARD_ERROR_OF_MEAN|0.759||0.019|TWO_SIDED|95.0|-3.278|-0.295|||ANCOVA|||||-0.295|-3.278|0.0190
72623470|NCT02301897|144777758|SUPERIORITY|||||||0.0601|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Week 18 Course 1||||0.0601
72478635|NCT00709852|144482992|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.63|STANDARD_DEVIATION|0.49|<|0.0001||||||for internal morphology|paired t test|||||||< 0.0001
72478636|NCT00709852|144482993|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.65|STANDARD_DEVIATION|1.27|<|0.0001||||||for border delineation|paired t test|||||||< 0.0001
72478637|NCT00709852|144482993|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.51|STANDARD_DEVIATION|1.01|<|0.0001||||||for internal morphology|paired t test|||||||< 0.0001
72478638|NCT00709852|144482994|NON_INFERIORITY_OR_EQUIVALENCE|noninferiority margin = -0.35|Mean Difference (Final Values)|0.06||||||95.0|0.03|0.096|||CI for paired means|lower limit of confidence interval is compared to noninferiority margin||analysis for contrast enhancement||0.096|0.030|
72478639|NCT00709852|144482994|NON_INFERIORITY_OR_EQUIVALENCE|noninferiority margin = -0.35|Mean Difference (Final Values)|0.04||||||95.0|0.003|0.071|||CI for paired means|lower limit of confidence interval is compared to noninferiority margin||analysis for border delineation||0.071|0.003|
72478640|NCT00709852|144482994|NON_INFERIORITY_OR_EQUIVALENCE|noninferiority margin = -0.35|Mean Difference (Final Values)|0.03||||||95.0|0.003|0.055|||CI for paired means|lower limit of confidence interval is compared to noninferiority margin||analysis for internal morphology||0.055|0.003|
72478641|NCT00709852|144482995|NON_INFERIORITY_OR_EQUIVALENCE|noninferiority margin = -0.35|Mean Difference (Final Values)|0.01|STANDARD_DEVIATION|0.59||||95.0|-0.049|0.078|||confidence interval for paired means|lower limit of confidence interval is compared to noninferiority margin||||0.078|-0.049|
72509119|NCT02389816|144548581|SUPERIORITY||LS mean difference|-0.36|STANDARD_ERROR_OF_MEAN|0.12||0.0031|TWO_SIDED|95.0|-0.59|-0.121|||ANCOVA|||||-0.121|-0.590|0.0031
72509120|NCT02389816|144548581|SUPERIORITY||LS mean difference|-0.39|STANDARD_ERROR_OF_MEAN|0.12||0.0011|TWO_SIDED|95.0|-0.629|-0.158|||ANCOVA|||||-0.158|-0.629|0.0011
72509121|NCT02389816|144548582|SUPERIORITY||LS mean difference|-0.23|STANDARD_ERROR_OF_MEAN|0.123||0.0609|TWO_SIDED|95.0|-0.474|0.011|||ANCOVA|||||0.011|-0.474|0.0609
72509122|NCT02389816|144548582|SUPERIORITY||LS mean difference|-0.29|STANDARD_ERROR_OF_MEAN|0.124||0.0179|TWO_SIDED|95.0|-0.537|-0.051|||ANCOVA|||||-0.051|-0.537|0.0179
72509123|NCT02389816|144548583|SUPERIORITY||LS mean difference|-1.34|STANDARD_ERROR_OF_MEAN|0.621||0.0311|TWO_SIDED|95.0|-2.564|-0.122|||ANCOVA|||||-0.122|-2.564|0.0311
72509124|NCT02389816|144548583|SUPERIORITY||LS mean difference|-1.57|STANDARD_ERROR_OF_MEAN|0.628||0.0126|TWO_SIDED|95.0|-2.807|-0.339|||ANCOVA|||||-0.339|-2.807|0.0126
72509125|NCT02389816|144548584|SUPERIORITY||LS mean difference|-0.79|STANDARD_ERROR_OF_MEAN|0.893||0.3793|TWO_SIDED|95.0|-2.539|0.968|||ANCOVA|||||0.968|-2.539|0.3793
72509126|NCT02389816|144548584|SUPERIORITY||LS mean difference|-0.11|STANDARD_ERROR_OF_MEAN|0.891||0.9011|TWO_SIDED|95.0|-1.862|1.641|||ANCOVA|||||1.641|-1.862|0.9011
72509127|NCT02389816|144548585|SUPERIORITY||LS mean difference|-0.87|STANDARD_ERROR_OF_MEAN|0.329||0.0089|TWO_SIDED|95.0|-1.512|-0.218|||ANCOVA|||||-0.218|-1.512|0.0089
72509128|NCT02389816|144548585|SUPERIORITY||LS mean difference|-1.27|STANDARD_ERROR_OF_MEAN|0.332||0.0001|TWO_SIDED|95.0|-1.922|-0.619|||ANCOVA|||||-0.619|-1.922|0.0001
72509129|NCT02417233|144548586|OTHER||Odds Ratio (OR)|0.958||||0.848|TWO_SIDED|95.0|0.62|1.49|||Regression, Logistic|||||1.49|0.62|0.848
72509130|NCT02417233|144548586|OTHER||Odds Ratio (OR)|1.492||||0.125|TWO_SIDED|95.0|0.9|2.49|||Regression, Logistic|||||2.49|0.90|0.125
72509131|NCT02417233|144548587|OTHER||Odds Ratio (OR)|0.866||||0.636|TWO_SIDED|96.0|0.48|1.57|||Regression, Logistic|||||1.57|0.48|0.636
72509132|NCT02417233|144548587|OTHER||Odds Ratio (OR)|1.401||||0.165|TWO_SIDED|95.0|0.87|2.26|||Regression, Logistic|||||2.26|0.87|0.165
72509133|NCT02417233|144548588|OTHER||Odds Ratio (OR)|1.48||||0.16|TWO_SIDED|95.0|0.86|2.55|||Regression, Logistic|||||2.55|0.86|0.16
72623471|NCT02301897|144777758|SUPERIORITY|||||||0.2168|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to On-Drug Course 2||||0.2168
72400030|NCT03255382|144307926|OTHER||Adjusted percentage difference|29.7|||<|0.001|TWO_SIDED|95.0|17.1|42.4|||Cochran-Mantel-Haenszel|||P-value was calculated from the CMH test adjusted for strata (prior phototherapy \[yes/no\]).||42.4|17.1|< 0.001
72566482|NCT02697773|144663292|SUPERIORITY||Odds Ratio (OR)|0.48||||0.1444|TWO_SIDED|95.0|0.18|1.29|||Regression, Logistic|||Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||1.29|0.18|0.1444
72400031|NCT03255382|144307927|OTHER||Adjusted percentage difference|66.7|||<|0.001|TWO_SIDED|95.0|53.4|80.0|||Cochran-Mantel-Haenszel|||P-value was calculated from the CMH test adjusted for strata (prior phototherapy \[yes/no\]).||80.0|53.4|< 0.001
72400032|NCT03255382|144307928|OTHER||Adjusted percentage difference|56.8|||<|0.001|TWO_SIDED|95.0|42.7|70.8|||Cochran-Mantel-Haenszel|||P-value was calculated from the CMH test adjusted for strata (prior phototherapy \[yes/no\]).||70.8|42.7|< 0.001
72478642|NCT00709852|144482996|NON_INFERIORITY_OR_EQUIVALENCE|noninferiority margin = -0.35|Mean Difference (Final Values)|0.03||||||95.0|-0.009|0.065|||CI for paired means|lower limit of confidence interval is compared to noninferiority margin||analysis for contrast enhancement||0.065|-0.009|
72478643|NCT00709852|144482996|NON_INFERIORITY_OR_EQUIVALENCE|noninferiority margin = -0.35|Mean Difference (Final Values)|-0.01||||||95.0|-0.04|0.02|||CI for paired means|lower limit of confidence interval is compared to noninferiority margin||analysis for border delineation||0.020|-0.040|
72478644|NCT00709852|144482996|NON_INFERIORITY_OR_EQUIVALENCE|noninferiority margin = -0.35|Mean Difference (Final Values)|0.01||||||95.0|-0.015|0.035|||CI for paired means|lower limit of confidence interval is compared to noninferiority margin||analysis for internal morphology||0.035|-0.015|
72478645|NCT00709852|144482997|NON_INFERIORITY_OR_EQUIVALENCE|noninferiority margin = -0.35|Mean Difference (Final Values)|0.1||||||95.0|0.042|0.153|||CI for paired means|lower limit of confidence interval is compared to noninferiority margin||analysis for contrast enhancement||0.153|0.042|
72478646|NCT00709852|144482997|NON_INFERIORITY_OR_EQUIVALENCE|noninferiority margin = -0.35|Mean Difference (Final Values)|0.1||||||95.0|0.03|0.161|||CI for paired means|lower limit of confidence interval is compared to noninferiority margin||analysis for border delineation||0.161|0.030|
72478647|NCT00709852|144482997|NON_INFERIORITY_OR_EQUIVALENCE|noninferiority margin = -0.35|Mean Difference (Final Values)|0.05||||||95.0|0.006|0.098|||CI for paired means|lower limit of confidence interval is compared to noninferiority margin||analysis for internal morphology||0.098|0.006|
72478648|NCT00709852|144482998|SUPERIORITY_OR_OTHER||Difference|6.2||||0.0082|||||||McNemar|||||||0.0082
72478649|NCT00709852|144482999|SUPERIORITY_OR_OTHER||Difference|9.9|||<|0.0001|||||||McNemar|||||||< 0.0001
72478650|NCT00709852|144483000|SUPERIORITY_OR_OTHER||Difference|6.8||||0.0039|||||||McNemar|||||||0.0039
72478651|NCT00709852|144483001|SUPERIORITY_OR_OTHER||Difference|9.2|||<|0.0001|||||||McNemar|||||||< 0.0001
72478652|NCT00709852|144483002|NON_INFERIORITY_OR_EQUIVALENCE|noninferiority margin = -10%|Difference in percentages|-0.4||||||95.0|-3.8|2.9|||CI for paired percentages|lower limit of confidence interval is compared to noninferiority margin||||2.9|-3.8|
72478653|NCT00709852|144483003|NON_INFERIORITY_OR_EQUIVALENCE|noninferiority margin = -10%|Difference in percentages|0.7||||||95.0|-0.3|1.6|||CI for paired percentages|lower limit of interval is compared to noninferiority margin||||1.6|-0.3|
72478654|NCT00709852|144483004|SUPERIORITY_OR_OTHER||Difference|10.5||||0.0002|||||||McNemar|||||||0.0002
72478655|NCT00709852|144483005|SUPERIORITY_OR_OTHER||Difference|13.6|||<|0.0001|||||||McNemar|||||||< 0.0001
72478656|NCT00709852|144483006|SUPERIORITY_OR_OTHER||Difference|0.0||||1|||||||McNemar|||||||1.0000
72478657|NCT00709852|144483007|SUPERIORITY_OR_OTHER||Difference|10.5||||0.0002|||||||McNemar|||||||0.0002
72566483|NCT02697773|144663292|SUPERIORITY||Odds Ratio (OR)|0.29||||0.0335|TWO_SIDED|95.0|0.09|0.91|||Regression, Logistic|||Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||0.91|0.09|0.0335
72478658|NCT00709852|144483008|SUPERIORITY_OR_OTHER||Difference|13.1||||0.0001|||||||McNemar|||||||0.0001
72478659|NCT00709852|144483009|SUPERIORITY_OR_OTHER||Difference|1.6||||0.763|||||||McNemar|||||||0.7630
72478660|NCT00709852|144483010|NON_INFERIORITY_OR_EQUIVALENCE|noninferiority margin = -10%|Difference in percentages|0.0||||||95.0|-3.1|3.1|||CI for paired percentages|lower limit of confidence interval is compared to noninferiority margin||||3.1|-3.1|
72478661|NCT00709852|144483011|NON_INFERIORITY_OR_EQUIVALENCE|noninferiority margin = -10%|Difference in percentages|0.5||||||95.0|-2.7|3.6|||CI for paired percentages|lower limit of confidence interval is compared to noninferiority margin||||3.6|-2.7|
72478662|NCT00709852|144483012|NON_INFERIORITY_OR_EQUIVALENCE|noninferiority margin = -10%|Difference in percentages|-1.6||||||95.0|-10.1|6.9|||CI for paired percentages|lower limit of confidence interval is compared to noninferiority margin||||6.9|-10.1|
72478663|NCT00709852|144483013|SUPERIORITY_OR_OTHER||Difference|6.5||||0.0006|||||||McNemar|||||||0.0006
72478664|NCT00709852|144483014|SUPERIORITY_OR_OTHER||Difference|19.4||||0.0004|||||||McNemar|||||||0.0004
72478665|NCT00709852|144483015|SUPERIORITY_OR_OTHER||Difference|0.5||||0.6547|||||||McNemar|||||||0.6547
72478666|NCT00709852|144483016|SUPERIORITY_OR_OTHER||Difference|7.9|||<|0.0001|||||||McNemar|||||||< 0.0001
72478667|NCT00709852|144483017|SUPERIORITY_OR_OTHER||Difference|21.5|||<|0.0001|||||||McNemar|||||||< 0.0001
72478668|NCT00709852|144483018|SUPERIORITY_OR_OTHER||Difference|1.5||||0.0833|||||||McNemar|||||||0.0833
72478669|NCT00709852|144483019|SUPERIORITY_OR_OTHER||Difference|4.5||||0.0236|||||||McNemar|||||||0.0236
72478670|NCT00709852|144483020|SUPERIORITY_OR_OTHER||Difference|12.9||||0.0186|||||||McNemar|||||||0.0186
72478671|NCT00709852|144483021|SUPERIORITY_OR_OTHER||Difference|0.5||||0.7055|||||||McNemar|||||||0.7055
72478672|NCT00709852|144483022|SUPERIORITY_OR_OTHER||Difference|7.2|||<|0.0001|||||||McNemar|||||||< 0.0001
72478673|NCT00709852|144483023|SUPERIORITY_OR_OTHER||Difference|20.4|||<|0.0001|||||||McNemar|||||||< 0.0001
72478674|NCT00709852|144483024|SUPERIORITY_OR_OTHER||Difference|1.0||||0.1573|||||||McNemar|||||||0.1573
72478675|NCT00709852|144483025|NON_INFERIORITY_OR_EQUIVALENCE|noninferiority margin = -10%|Difference in percentages|2.1||||||95.0|0.2|3.9|||CI for paired percentages|lower limit of confidence interval is compared to noninferiority margin||||3.9|0.2|
72623472|NCT02301897|144777758|SUPERIORITY|||||||0.0101|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to On-Drug Course 2||||0.0101
72623473|NCT02301897|144777758|SUPERIORITY|||||||0.243|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Week 18 Course 2||||0.2430
72478676|NCT00709852|144483026|NON_INFERIORITY_OR_EQUIVALENCE|noninferiority margin = -10%|Difference in percentages|6.5||||||95.0|1.5|11.4|||CI for paired percentages|lower limit of confidence interval is compared to noninferiority margin||||11.4|1.5|
72478677|NCT00709852|144483027|NON_INFERIORITY_OR_EQUIVALENCE|noninferiority margin = -10%|Difference in percentages|0.0||||||95.0|-1.4|1.4|||CI for paired percentages|lower limit of confidence interval is compared to noninferiority margin||||1.4|-1.4|
72478678|NCT00709852|144483028|NON_INFERIORITY_OR_EQUIVALENCE|noninferiority margin = -10%|Difference in percentages|0.7||||||95.0|-0.3|1.6|||CI for paired percentages|lower limit of confidence interval is compared to noninferiority margin||||1.6|-0.3|
72478679|NCT00709852|144483029|NON_INFERIORITY_OR_EQUIVALENCE|noninferiority margin = -10%|Difference in percentages|1.1||||||95.0|-1.0|3.2|||CI for paired percentages|lower limit of confidence interval is compared to noninferiority margin||||3.2|-1.0|
72478680|NCT00709852|144483030|NON_INFERIORITY_OR_EQUIVALENCE|noninferiority margin = -10%|Difference in percentages|0.5||||||95.0|-0.5|1.5|||CI for paired percentages|lower limit of confidence interval is compared to noninferiority margin||||1.5|-0.5|
72478681|NCT00709852|144483031|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.57|STANDARD_DEVIATION|0.56|<|0.0001|||||||paired t test|||||||< 0.0001
72478682|NCT00709852|144483032|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.57|STANDARD_DEVIATION|0.58|<|0.0001|||||||paired t test|||||||< 0.0001
72478683|NCT00709852|144483033|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_DEVIATION|0.48||||||||||||||||
72478684|NCT00709852|144483034|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.76|STANDARD_DEVIATION|0.93|<|0.0001|||||||paired t test|||||||< 0.0001
72478685|NCT00709852|144483035|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.73|STANDARD_DEVIATION|0.89|<|0.0001|||||||paired t test|||||||< 0.0001
72478686|NCT00709852|144483036|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.04|STANDARD_DEVIATION|0.39||||||||||||||||
72478687|NCT00709852|144483037|SUPERIORITY_OR_OTHER||||||<|0.0001||||||for all three readers|t-test, 2 sided|||||||< 0.0001
72478688|NCT00709852|144483039|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_DEVIATION|1.06||||||||||||||||
72478689|NCT00709852|144483040|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.4|STANDARD_DEVIATION|26.6||||||||||||||||
72478690|NCT00825825|144483112|SUPERIORITY_OR_OTHER|||||||0.000704||95.0|||||Mixed Models Analysis|||This analysis is a comparison between the escitalopram and citalopram medication periods.||||0.000704
72478691|NCT00825825|144483113|SUPERIORITY_OR_OTHER|||||||1.62e-05||95.0|||||Mixed Models Analysis|||This analysis is a comparison between the escitalopram and citalopram medication periods.||||0.0000162
72509134|NCT02417233|144548588|OTHER||Odds Ratio (OR)|1.82||||0.03|TWO_SIDED|95.0|1.06|3.14|||Regression, Logistic|||||3.14|1.06|0.03
72478692|NCT00825825|144483114|SUPERIORITY_OR_OTHER|||||||9.36e-06||95.0|||||Mixed Models Analysis|||This analysis is a comparison between the citalopram and placebo medication periods.||||0.00000936
72478693|NCT00825825|144483115|SUPERIORITY_OR_OTHER|||||||0.0279||95.0|||||Mixed Models Analysis|||This analysis is a comparison between the citalopram and placebo medication periods.||||0.0279
72478694|NCT00825825|144483116|SUPERIORITY_OR_OTHER|||||||0.00124||95.0|||||Mixed Models Analysis|||This analysis is a comparison between the escitalopram and placebo medication periods.||||0.00124
72478695|NCT00825825|144483117|SUPERIORITY_OR_OTHER|||||||6.33e-05||95.0|||||Mixed Models Analysis|||This analysis is a comparison between the placebo and citalopram medication periods.||||0.0000633
72478696|NCT00825825|144483118|SUPERIORITY_OR_OTHER|||||||0.0241||95.0|||||Mixed Models Analysis|||This analysis is a comparison between the escitalopram and citalopram medication periods.||||0.0241
72478697|NCT02697292|144483119|SUPERIORITY||Odds Ratio (OR)|10.5||||0.044|TWO_SIDED|95.0|1.1|98.9|||t-test, 1 sided|||||98.9|1.1|0.044
72478698|NCT02697292|144483120|SUPERIORITY|||||||0.1|||||||Wilcoxon (Mann-Whitney)|||||||0.100
72478699|NCT01043393|144483163|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.779|||||TWO_SIDED|95.0|0.055|11.126||||||||11.126|0.055|
72478700|NCT02673515|144483215|OTHER|||||||0.797|||||||t-test, 2 sided|||Comparison of changes from baseline to 4 weeks between groups was tested with student´s t-test or Mann Whitney-U-Test||||0.797
72478701|NCT00910689|144483306|SUPERIORITY_OR_OTHER||||||<|0.01||||||Post tests consisted of 6 pair wise contrasts: The first 3 contrasts compared each of the 3 additive treatments (Trial Arms 2, 3, 4) to OAT + PL (Trial arm 1); 3 additional contrasts compared the 3 additive treatments to one another.|Mixed Models Analysis|A Bonferoni procedure was used to control the family-wise type I error for the 6 post test contrasts at .05. Adjusted p =.0083.||Omnibus Test: A mixed model with fixed effects for treatment,natural time(defined as natural log of months) and treatment-by-time interaction was used to obtain maximum likelihood estimates of missing values and to evaluate treatment effects(using the PROC MIXED procedure in SAS statistical software,version 9;www.sas.com). A significant treatment by time interaction(p \< .05, 2-tailed) was followed by post-tests (see below). Details of significant post tests are reported as separate analyses.||||< .01
72478702|NCT00910689|144483306|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.2|STANDARD_DEVIATION|0.57|<|0.001||95.0||||Bonferoni adjusted critical value p = .0083.|t-test, 2 sided|Degrees of freedom = 1 and 122.||Post-test contrast. Mean difference in change.||||< .001
72478703|NCT00910689|144483306|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.1|STANDARD_DEVIATION|0.68|>|0.25|TWO_SIDED|95.0||||Bonferoni adjusted critical value p = .0083.|t-test, 2 sided|Degrees of freedom = 1 and 108.||Post-test contrast. Mean difference in change.||||> .25
72478704|NCT00910689|144483306|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0|STANDARD_DEVIATION|0.59|>|0.98|TWO_SIDED|95.0||||Bonferoni adjusted critical value p = .0083.|t-test, 2 sided|Degrees of freedom = 1 and 106.||Post-test contrast. Mean difference in change.||||> .98
72509135|NCT02417233|144548589|OTHER||Odds Ratio (OR)|0.27||||0.24|TWO_SIDED|95.0|0.03|2.45|||Regression, Logistic|||||2.45|0.03|0.24
72509136|NCT02417233|144548589|OTHER||Odds Ratio (OR)|2.68||||0.2|TWO_SIDED|95.0|0.59|12.16|||Regression, Logistic|||||12.16|0.59|0.20
72509137|NCT02417233|144548590|OTHER||Odds Ratio (OR)|1.943||||0.093|TWO_SIDED|95.0|0.9|4.21|||Regression, Logistic|||||4.21|0.90|0.093
72509138|NCT02417233|144548590|OTHER||Odds Ratio (OR)|1.764||||0.152|TWO_SIDED|95.0|0.81|3.83|||Regression, Logistic|||||3.83|0.81|0.152
72623474|NCT02301897|144777758|SUPERIORITY|||||||0.0843|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Week 18 Course 2||||0.0843
72623475|NCT02301897|144777758|SUPERIORITY|||||||0.557|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Course 2 Week 24 FU||||0.5570
72478705|NCT00910689|144483306|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.1|STANDARD_DEVIATION|0.69|<|0.001|TWO_SIDED|95.0||||Bonferoni adjusted critical value p = .0083.|t-test, 2 sided|Degrees of freedom = 1 and 122.||Post-test contrast. Mean difference in change.||||< .001
72478706|NCT00910689|144483306|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.3|STANDARD_DEVIATION|0.61|<|0.001|TWO_SIDED|95.0||||Bonferoni adjusted critical value p = .0083.|t-test, 2 sided|Degrees of freedom = 1 and 120.||Post-test contrast. Mean difference in change.||||<.001
72478707|NCT00910689|144483306|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.1|STANDARD_DEVIATION|0.72|>|0.29|TWO_SIDED|95.0||||Bonferoni adjusted critical value p = .0083.|t-test, 2 sided|Degrees of freedom = 1 and 106.||Post-test contrast. Mean difference in change.||||>.29
72478708|NCT00910689|144483307|SUPERIORITY_OR_OTHER||||||<|0.03|TWO_SIDED|95.0||||6 pair wise contrasts were conducted: The first 3 contrasts compared each of the 3 additive treatments to OAT + PL. The 3 additional contrasts compared the 3 additive treatments to one another.|Mixed Models Analysis|A Bonferoni procedure was used to control the family wise type I error for the 6 post test contrasts at .05. Adjusted p =.0083.||Omnibus test:A mixed model with fixed effects for treatment, time (defined as the natural log of months), and the treatment-by-time interaction was used to obtain maximum likelihood estimates of missing values and to evaluate treatment effects (PROC MIXED, SAS 9).When the treatment by time interaction was significant (p \< .05, 2-tailed)post-tests were conducted (see below).Details of significant post tests are reported as separate analyses.||||< .03
72509139|NCT02985450|144548611|OTHER||Mean Difference (Final Values)|513.5|STANDARD_DEVIATION|73.6||0.02|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||Anti-HBs levels difference: high risk obesity group - low risk obesity group NAFLD patients|||||0.02
72509140|NCT00431847|144548621|SUPERIORITY_OR_OTHER||Slope|-0.0323|STANDARD_ERROR_OF_MEAN|0.00619|<|0.0001|TWO_SIDED|95.0|-0.0448|-0.02013|||Mixed Models Analysis|||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group. The overall slope of the model (below) is reported as a continuous variable for time since injury.||-0.02013|-0.0448|<0.0001
72509141|NCT00431847|144548621|SUPERIORITY_OR_OTHER||Chi Squared|2.65||||0.4492|TWO_SIDED||||||Chi-squared|Degrees of Freedom: 3||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The time interaction component of the model is reported below.||||0.4492
72478709|NCT00910689|144483307|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.0|STANDARD_DEVIATION|1.03|<|0.001|TWO_SIDED|95.0||||Bonferoni adjusted critical value p = .0083.|t-test, 2 sided|Degrees of freedom = 1 and 122.||Post-test contrast. Mean difference in change.||||< .001
72478710|NCT00910689|144483307|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.5|STANDARD_DEVIATION|1.12|<|0.001|TWO_SIDED|95.0||||Bonferoni adjusted critical value p = .0083.|t-test, 2 sided|Degrees of freedom = 1 and 122.||Post-test contrast. Mean difference in change.||||< .001
72478711|NCT00910689|144483307|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.1|STANDARD_DEVIATION|1.26|<|0.001|TWO_SIDED|95.0||||Bonferoni adjusted critical value p = .0083.|t-test, 2 sided|Degrees of freedom = 1 and 122.||Post-test contrast. Mean difference in change.||||< .001
72509142|NCT00431847|144548621|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.108|STANDARD_ERROR_OF_MEAN|0.2308||0.64|TWO_SIDED|95.0|-0.5621|0.3461|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.|Estimated intercept group difference|A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.||0.3461|-0.5621|0.640
72623476|NCT02301897|144777758|SUPERIORITY|||||||0.5302|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Course 2 Week 24 FU||||0.5302
72478712|NCT00910689|144483307|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.5|STANDARD_DEVIATION|1.2|>|0.02|TWO_SIDED|95.0||||Bonferoni adjusted critical value p = .0083.|t-test, 2 sided|Degrees of freedom = 1 and 106.||Post-test contrast. Mean difference in change.||||> .02
72478713|NCT00910689|144483307|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.1|STANDARD_DEVIATION|1.35|>|0.79||95.0||||Bonferoni adjusted critical value p = .0083.|t-test, 2 sided|Degrees of freedom = 1 and 108.||Post-test contrast. Mean difference in change.||||>.79
72509143|NCT00431847|144548621|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.3299|STANDARD_ERROR_OF_MEAN|0.3372||0.3286|TWO_SIDED|95.0|-0.3334|0.9932|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.||0.9932|-0.3334|0.3286
72509144|NCT00431847|144548621|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.8591|STANDARD_ERROR_OF_MEAN|0.4716||0.0694|TWO_SIDED|95.0|-0.06841|1.7866|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.||1.7866|-0.06841|0.0694
72509145|NCT00431847|144548622|SUPERIORITY_OR_OTHER||Slope|-0.02332|STANDARD_ERROR_OF_MEAN|0.003777|<|0.0001|TWO_SIDED|95.0|-0.03076|-0.01589|||Mixed Models Analysis|||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group. The overall slope of the model (below) is reported as a continuous variable for time since injury.||-0.01589|-0.03076|<0.0001
72623477|NCT02301897|144777759|SUPERIORITY|||||||0.0504|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Week 18 Course 1||||0.0504
72623478|NCT02301897|144777759|SUPERIORITY|||||||0.0151|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Week 18 Course 1||||0.0151
72623479|NCT02301897|144777759|SUPERIORITY|||||||0.5932|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to On-Drug Course 2||||0.5932
72400033|NCT03255382|144307929|OTHER||Adjusted percentage difference|59.9|||<|0.001|TWO_SIDED|95.0|46.3|73.6|||Cochran-Mantel-Haenszel|||P-value was calculated from the CMH test adjusted for strata (prior phototherapy \[yes/no\]).||73.6|46.3|< 0.001
72400034|NCT03255382|144307930|OTHER||Adjusted percentage difference|44.9|||<|0.001|TWO_SIDED|95.0|30.8|59.1|||Cochran-Mantel-Haenszel|||P-value was calculated from the CMH test adjusted for strata (prior phototherapy \[yes/no\]).||59.1|30.8|< 0.001
72400035|NCT03255382|144307931|OTHER||Adjusted percentage difference|55.0|||<|0.001|TWO_SIDED|95.0|41.2|68.8|||Cochran-Mantel-Haenszel|||P-value was calculated from the CMH test adjusted for strata (prior phototherapy \[yes/no\]).||68.8|41.2|< 0.001
72509146|NCT00431847|144548622|SUPERIORITY_OR_OTHER||Chi-Squared|2.49||||0.4772|TWO_SIDED||||||Chi-squared|Degrees of Freedom: 3||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The time interaction component of the model is reported below.||||0.4772
72509147|NCT00431847|144548622|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.07724|STANDARD_ERROR_OF_MEAN|0.1503||0.6077|TWO_SIDED|95.0|-0.2184|0.3729|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.||0.3729|-0.2184|0.6077
72509148|NCT00431847|144548622|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.2004|STANDARD_ERROR_OF_MEAN|0.2194||0.3616|TWO_SIDED|95.0|-0.2311|0.6319|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.||0.6319|-0.2311|0.3616
72400036|NCT03255382|144307932|OTHER||Adjusted percentage difference|1.7||||0.392|TWO_SIDED|95.0|-2.1|5.4|||Cochran-Mantel-Haenszel|||P-value was calculated from the CMH test adjusted for strata (prior phototherapy \[yes/no\]).||5.4|-2.1|0.392
72478714|NCT00910689|144483307|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.6|STANDARD_DEVIATION|1.43|>|0.02||95.0||||Bonferoni adjusted critical value p = .0083.|t-test, 2 sided|||Post-test contrast. Mean difference in change.||||>.02
72478715|NCT00910689|144483308|SUPERIORITY_OR_OTHER||||||<|0.005|TWO_SIDED|95.0||||Post tests consisted of 6 pair wise contrasts: The first 3 contrasts compared each of the 3 additive treatments (Trial Arms 2, 3, 4) to OAT + PL (Trial arm 1); three additional contrasts compared the 3 additive treatments to one another.|Mixed Models Analysis|A Bonferoni procedure controlled the familywise type I error for the 6 contrasts at .05. Adjusted p=.0083.||Omnibus test:A mixed model with fixed effects for treatment, time (defined as the natural log of months), and the treatment-by-time interaction and pretreatment Migraine Specific Quality of Life scores as covariate was used to obtain maximum likelihood estimates of missing values and to evaluate treatment effects (using the PROC MIXED procedure in SAS statistical software, version 9; www. sas.com).A significant treatment by time interaction (p \< .05, 2-tailed) was followed by post-tests||||<.005
72509149|NCT00431847|144548622|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.3082|STANDARD_ERROR_OF_MEAN|0.3066||0.3155|TWO_SIDED|95.0|-0.2948|0.9112|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.||0.9112|-0.2948|0.3155
72509150|NCT00431847|144548623|SUPERIORITY_OR_OTHER||Slope|-0.02746|STANDARD_ERROR_OF_MEAN|0.004202|<|0.0001|TWO_SIDED|95.0|-0.03573|-0.01919|||Mixed Models Analysis|||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group. The overall slope of the model (below) is reported as a continuous variable for time since injury.||-0.01919|-0.03573|<0.0001
72509151|NCT00431847|144548623|SUPERIORITY_OR_OTHER||Chi-Squared|3.4||||0.3345|TWO_SIDED||||||Chi-squared|Degrees of Freedom: 3||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The time interaction component of the model is reported below.||||0.3345
72566484|NCT02697773|144663293|SUPERIORITY|||||||0.0809||||||P-value was based on the log-rank test.|Log Rank|||Missing data for the selected percentile(s) was due to the Kaplan-Meier estimate not reaching the level for discontinuation due to lack of efficacy.||||0.0809
72623480|NCT02301897|144777759|SUPERIORITY|||||||0.0831|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to On-Drug Course 2||||0.0831
72400037|NCT03255382|144307933|OTHER||Adjusted percentage difference|8.4||||0.048|TWO_SIDED|95.0|0.1|16.7|||Cochran-Mantel-Haenszel|||P-value was calculated from the CMH test adjusted for strata (prior phototherapy \[yes/no\]).||16.7|0.1|0.048
72400038|NCT03255382|144307934|OTHER||Adjusted percentage difference|18.3||||0.001|TWO_SIDED|95.0|7.1|29.5|||Cochran-Mantel-Haenszel|||P-value was calculated from the CMH test adjusted for strata (prior phototherapy \[yes/no\]).||29.5|7.1|0.001
72400039|NCT03255382|144307935|OTHER||Adjusted percentage difference|33.0|||<|0.001|TWO_SIDED|95.0|20.2|45.9|||Cochran-Mantel-Haenszel|||P-value was calculated from the CMH test adjusted for strata (prior phototherapy \[yes/no\]).||45.9|20.2|< 0.001
72400040|NCT03255382|144307936|OTHER||Adjusted percentage difference|41.3|||<|0.001|TWO_SIDED|95.0|27.3|55.3|||Cochran-Mantel-Haenszel|||P-value was calculated from the CMH test adjusted for strata (prior phototherapy \[yes/no\]).||55.3|27.3|< 0.001
72400041|NCT03255382|144307937|OTHER||Adjusted percentage difference|46.4|||<|0.001|TWO_SIDED|95.0|32.6|60.1|||Cochran-Mantel-Haenszel|||P-value was calculated from the CMH test adjusted for strata (prior phototherapy \[yes/no\]).||60.1|32.6|< 0.001
72400042|NCT03255382|144307938|OTHER||Adjusted percentage difference|19.8||||0.001|TWO_SIDED|95.0|7.6|31.9|||Cochran-Mantel-Haenszel|||P-value was calculated from the CMH test adjusted for strata (prior phototherapy \[yes/no\]).||31.9|7.6|0.001
72623481|NCT02301897|144777759|SUPERIORITY|||||||0.1416|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Week 18 Course 2||||0.1416
72566485|NCT02697773|144663293|SUPERIORITY|||||||0.0239||||||P-value was based on the log-rank test.|Log Rank|||Missing data for the selected percentile(s) was due to the Kaplan-Meier estimate not reaching the level for discontinuation due to lack of efficacy.||||0.0239
72566486|NCT02697773|144663294|SUPERIORITY||Odds Ratio (OR)|0.7||||0.0761|TWO_SIDED|95.0|0.48|1.04|||Regression, Logistic|||Week 2: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||1.04|0.48|0.0761
72566487|NCT02697773|144663294|SUPERIORITY||Odds Ratio (OR)|0.65||||0.0312|TWO_SIDED|95.0|0.44|0.96|||Regression, Logistic|||Week 2: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||0.96|0.44|0.0312
72566488|NCT02697773|144663294|SUPERIORITY||Odds Ratio (OR)|0.65||||0.0262|TWO_SIDED|95.0|0.45|0.95|||Regression, Logistic|||Week 4: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||0.95|0.45|0.0262
72566489|NCT02697773|144663294|SUPERIORITY||Odds Ratio (OR)|0.54||||0.0013|TWO_SIDED|95.0|0.37|0.79|||Regression, Logistic|||Week 4: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||0.79|0.37|0.0013
72566490|NCT02697773|144663294|SUPERIORITY||Odds Ratio (OR)|0.92||||0.6706|TWO_SIDED|95.0|0.64|1.33|||Regression, Logistic|||Week 8: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||1.33|0.64|0.6706
72566491|NCT02697773|144663294|SUPERIORITY||Odds Ratio (OR)|0.99||||0.972|TWO_SIDED|95.0|0.69|1.43|||Regression, Logistic|||Week 8: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||1.43|0.69|0.9720
72566492|NCT02697773|144663294|SUPERIORITY||Odds Ratio (OR)|0.89||||0.5311|TWO_SIDED|95.0|0.61|1.29|||Regression, Logistic|||Week 12: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||1.29|0.61|0.5311
72566493|NCT02697773|144663294|SUPERIORITY||Odds Ratio (OR)|0.77||||0.1712|TWO_SIDED|95.0|0.53|1.12|||Regression, Logistic|||Week 12: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||1.12|0.53|0.1712
72566494|NCT02697773|144663294|SUPERIORITY||Odds Ratio (OR)|1.06||||0.7475|TWO_SIDED|95.0|0.73|1.54|||Regression, Logistic|||Week 16: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||1.54|0.73|0.7475
72566495|NCT02697773|144663294|SUPERIORITY||Odds Ratio (OR)|0.92||||0.6564|TWO_SIDED|95.0|0.63|1.33|||Regression, Logistic|||Week 16: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||1.33|0.63|0.6564
72566496|NCT02697773|144663296|SUPERIORITY||LS Mean Ratio|0.92|STANDARD_ERROR_OF_MEAN|0.11||0.4833|TWO_SIDED|95.0|0.73|1.16|||Negative binomial model|||Week 2: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.||1.16|0.73|0.4833
72566497|NCT02697773|144663296|SUPERIORITY|Week 2: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.|LS Mean Ratio|0.82|STANDARD_ERROR_OF_MEAN|0.1||0.0942|TWO_SIDED|95.0|0.65|1.03|||Negative binomial model|||||1.03|0.65|0.0942
72400043|NCT03255382|144307939|OTHER||Adjusted percentage difference|38.3|||<|0.001|TWO_SIDED|95.0|25.0|51.5|||Cochran-Mantel-Haenszel|||P-value was calculated from the CMH test adjusted for strata (prior phototherapy \[yes/no\]).||51.5|25.0|< 0.001
72566498|NCT02697773|144663296|SUPERIORITY||LS Mean Ratio|0.88|STANDARD_ERROR_OF_MEAN|0.12||0.3371|TWO_SIDED|95.0|0.67|1.15|||Negative binomial model|||Week 4: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.||1.15|0.67|0.3371
72566499|NCT02697773|144663296|SUPERIORITY||LS Mean Ratio|0.76|STANDARD_ERROR_OF_MEAN|0.11||0.0508|TWO_SIDED|95.0|0.58|1.0|||Negative binomial model|||Week 4: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.||1.00|0.58|0.0508
72566500|NCT02697773|144663296|SUPERIORITY||LS Mean Ratio|0.95|STANDARD_ERROR_OF_MEAN|0.14||0.728|TWO_SIDED|95.0|0.71|1.27|||Negative binomial model|||Week 8: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.||1.27|0.71|0.7280
72566501|NCT02697773|144663296|SUPERIORITY||LS Mean Ratio|0.87|STANDARD_ERROR_OF_MEAN|0.13||0.3244|TWO_SIDED|95.0|0.65|1.15|||Negative binomial model|||Week 8: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.||1.15|0.65|0.3244
72623482|NCT02301897|144777759|SUPERIORITY|||||||0.0392|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Week 18 Course 2||||0.0392
72623483|NCT02301897|144777759|SUPERIORITY|||||||0.8275|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Course 2 Week 24 FU||||0.8275
72623484|NCT02301897|144777759|SUPERIORITY|||||||0.8733|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Course 2 Week 24 FU||||0.8733
72478716|NCT00910689|144483308|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.5|STANDARD_DEVIATION|2.18|<|0.001|TWO_SIDED|95.0||||Bonferoni adjusted critical value p = .0083.|t-test, 2 sided|Degrees of freedom = 1 and 108.||Post-test contrast. Mean difference in change.||||< .001
72478717|NCT00910689|144483308|SUPERIORITY_OR_OTHER||Mean Difference (Net)|6.0|STANDARD_DEVIATION|2.41|<|0.001|TWO_SIDED|95.0||||Bonferoni adjusted critical value p = .0083.|t-test, 2 sided|Degrees of freedom = 1 and 122.||Post-test contrast. Mean difference in change.||||< .001
72478718|NCT00910689|144483308|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.4|STANDARD_DEVIATION|1.67|<|0.001|TWO_SIDED|95.0||||Bonferoni adjusted critical value p = .0083.|t-test, 2 sided|Degrees of freedom = 1 and 106.||Post-test contrast. Mean difference in change.||||< .001
72478719|NCT00910689|144483308|SUPERIORITY_OR_OTHER||Mean Difference (Net)|5.9|STANDARD_DEVIATION|2.03|<|0.001|TWO_SIDED|95.0||||Bonferoni adjusted critical value p = .0083.|t-test, 2 sided|Degrees of freedom = 1 and 120.||Post-test contrast. Mean difference in change.||||<.001
72478720|NCT00910689|144483308|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.5|STANDARD_DEVIATION|1.83|<|0.001|TWO_SIDED|95.0||||Bonferoni adjusted critical value p = .0083.|t-test, 2 sided|Degrees of freedom = 1 and 122.||Post-test contrast. Mean difference in change.||||< .001
72478721|NCT00910689|144483308|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.1|STANDARD_DEVIATION|2.38|>|0.87||95.0||||Bonferoni adjusted critical value p = .0083.|t-test, 2 sided|Degrees of freedom = 1 and 106.||Post-test contrast. Mean difference in change.||||>.87
72478722|NCT00910689|144483309|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.3|STANDARD_DEVIATION|0.77|<|0.001|TWO_SIDED|95.0||||Bonferoni adjusted critical value p = .0083.|t-test, 2 sided|Degrees of freedom = 1 and 122.||Post-test contrast. Mean difference in change.||||<.001
72509152|NCT00431847|144548623|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0386|STANDARD_ERROR_OF_MEAN|0.1718||0.8223|TWO_SIDED|95.0|-0.2993|0.3765|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.||0.3765|-0.2993|0.8223
72509153|NCT00431847|144548623|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.2919|STANDARD_ERROR_OF_MEAN|0.2506||0.2448|TWO_SIDED|95.0|-0.2009|0.7848|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.||0.7848|-0.2009|0.2448
72509154|NCT00431847|144548623|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.4482|STANDARD_ERROR_OF_MEAN|0.3502||0.2014|TWO_SIDED|95.0|-0.2405|1.1369|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.||1.1369|-0.2405|0.2014
72566502|NCT02697773|144663296|SUPERIORITY||LS Mean Ratio|0.91|STANDARD_ERROR_OF_MEAN|0.16||0.5681|TWO_SIDED|95.0|0.65|1.27|||Negative binomial model|||Week 12: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.||1.27|0.65|0.5681
72566503|NCT02697773|144663296|SUPERIORITY||LS Mean Ratio|0.77|STANDARD_ERROR_OF_MEAN|0.13||0.1387|TWO_SIDED|95.0|0.55|1.09|||Negative binomial model|||Week 12: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.||1.09|0.55|0.1387
72478723|NCT00910689|144483309|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0|STANDARD_DEVIATION|0.79|>|0.83|TWO_SIDED|95.0||||Bonferoni adjusted critical value p = .0083.|t-test, 2 sided|Degrees of freedom = 1 and 106.||Post-test contrast. Mean difference in change.||||> .83
72478724|NCT00910689|144483309|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.2|STANDARD_DEVIATION|0.67|>|0.05|TWO_SIDED|95.0||||Bonferoni adjusted critical value p = .0083.|t-test, 2 sided|Degrees of freedom = 1 and 108.||Post-test contrast. Mean difference in change.||||> .05
72478725|NCT00910689|144483309|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.1|STANDARD_DEVIATION|0.86|<|0.001|TWO_SIDED|95.0||||Bonferoni adjusted critical value p = .0083.|t-test, 2 sided|Degrees of freedom = 1 and 122.||Significant post-test contrast. Mean difference in change.||||< .001
72478726|NCT00910689|144483309|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.3|STANDARD_DEVIATION|0.95|<|0.001|TWO_SIDED|95.0||||Bonferoni adjusted critical value p = .0083.|t-test, 2 sided|Degrees of freedom = 1 and 120.||Post-test contrast. Mean difference in change.||||<.001
72478727|NCT00910689|144483309|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.2|STANDARD_DEVIATION|0.89|>|0.2|TWO_SIDED|95.0||||Bonferoni adjusted critical value p = .0083.|t-test, 2 sided|Degrees of freedom = 1 and 106.||Post-test contrast. Mean difference in change.||||> .20
72478728|NCT00910689|144483310|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.2|STANDARD_DEVIATION|1.7|<|0.001|TWO_SIDED|95.0||||Bonferoni adjusted critical value p = .0083.|t-test, 2 sided|Degrees of freedom = 1 and 122.||Post-test contrast. Mean difference in change.||||<.001
72509155|NCT00431847|144548624|SUPERIORITY_OR_OTHER||Slope|-0.0403|STANDARD_ERROR_OF_MEAN|0.007196|<|0.0001|TWO_SIDED|95.0|-0.5446|-0.02613|||Mixed Models Analysis|||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.||-0.02613|-0.5446|<0.0001
72509156|NCT00431847|144548624|SUPERIORITY_OR_OTHER||Chi-Squared|3.19||||0.3631|TWO_SIDED||||||Chi-squared|Degrees of Freedom: 3||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The time interaction component of the model is reported below.||||0.3631
72623485|NCT02301897|144777760|SUPERIORITY|||||||0.0651|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Week 18 Course 1||||0.0651
72623486|NCT02301897|144777760|SUPERIORITY|||||||0.0298|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Week 18 Course 1||||0.0298
72623487|NCT02301897|144777760|SUPERIORITY|||||||0.4005|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to On-Drug Course 2||||0.4005
72623488|NCT02301897|144777760|SUPERIORITY|||||||0.1114|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to On-Drug Course 2||||0.1114
72623489|NCT02301897|144777760|SUPERIORITY|||||||0.1318|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Week 18 Course 2||||0.1318
72623490|NCT02301897|144777760|SUPERIORITY|||||||0.0807|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Week 18 Course 2||||0.0807
72623491|NCT02301897|144777760|SUPERIORITY|||||||0.4506|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Course 2 Week 24 FU||||0.4506
72623492|NCT02301897|144777760|SUPERIORITY|||||||0.4614|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Course 2 Week 24 FU||||0.4614
72400044|NCT03255382|144307940|OTHER||Least Squares Mean Difference|-3.2|STANDARD_ERROR_OF_MEAN|0.63|<|0.001|TWO_SIDED|95.0|-4.5|-2.0|||van Elteren test|||P-values were calculated by stratified van Elteren test.||-2.0|-4.5|< 0.001
72400045|NCT03255382|144307941|OTHER||Least Squares Mean Difference|-3.9|STANDARD_ERROR_OF_MEAN|0.59|<|0.001|TWO_SIDED|95.0|-5.1|-2.7|||van Elteren test|||P-values were calculated by stratified van Elteren test.||-2.7|-5.1|< 0.001
72478729|NCT00910689|144483310|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.6|STANDARD_DEVIATION|1.96|<|0.001|TWO_SIDED|95.0||||Bonferoni adjusted critical value p = .0083.|t-test, 2 sided|Degrees of freedom = 1 and 120.||Post-test contrast. Mean difference in change.||||<.001
72478730|NCT00910689|144483310|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.0|STANDARD_DEVIATION|1.69|<|0.001|TWO_SIDED|95.0||||Bonferoni adjusted critical value p = .0083.|t-test, 2 sided|Degrees of freedom = 1 and 122.||Post-test contrast. Mean difference in change.||||< .001
72478731|NCT00910689|144483310|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.6|STANDARD_DEVIATION|1.69|>|0.04||95.0||||Bonferoni adjusted critical value p = .0083.|t-test, 2 sided|Degrees of freedom = 1 and 106.||Post-test contrast. Mean difference in change.||||>.04
72478732|NCT00910689|144483310|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.2|STANDARD_DEVIATION|1.34|>|0.33||95.0||||Bonerfoni adjusted critical value p = .0083.|t-test, 2 sided|Degrees of freedom = 1 and 108.||Post-test contrast. Mean difference in change.||||>0.33
72478733|NCT00910689|144483310|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.2|STANDARD_DEVIATION|1.68|>|0.21||95.0||||Bonferoni adjusted critical value p = .0083.|t-test, 2 sided|Degrees of freedom = 1 and 106.||Post-test contrast. Mean difference in change.||||>0.21
72478734|NCT00910689|144483311|SUPERIORITY_OR_OTHER||Mean Difference (Net)|6.4|STANDARD_DEVIATION|3.0|<|0.001|TWO_SIDED|95.0||||Bonferoni adjusted critical value p = .0083.|t-test, 2 sided|Degrees of freedom = 1 and 122.||Post-test contrast. Mean difference in change.||||< .001
72478735|NCT00910689|144483311|SUPERIORITY_OR_OTHER||Mean Difference (Net)|6.7|STANDARD_DEVIATION|3.29|<|0.001|TWO_SIDED|95.0||||Bonferoni adjusted critical value p = .0083.|t-test, 2 sided|Degrees of freedom = 1 and 122.||Post-test contrast. Mean difference in change.||||< .001
72478736|NCT00910689|144483311|SUPERIORITY_OR_OTHER||Mean Difference (Net)|5.6|STANDARD_DEVIATION|2.99|<|0.001|TWO_SIDED|95.0||||Bonferoni adjusted critical value p = .0083.|t-test, 2 sided|Degrees of freedom = 1 and 122.||Post-test contrast. Mean difference in change.||||< .001
72478737|NCT00910689|144483311|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.3|STANDARD_DEVIATION|2.85|>|0.56||95.0||||Bonferoni adjusted critical value p = .0083.|t-test, 2 sided|Degrees of freedom = 1 and 106.||Post-test contrast. Mean difference in change.||||>0.56
72478738|NCT00910689|144483311|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.8|STANDARD_DEVIATION|2.45|>|0.08||95.0||||Bonferoni adjusted critical value p = .0083.|t-test, 2 sided|Degrees of freedom = 1 and 108.||Post-test contrast. Mean difference in change.||||>0.08
72623493|NCT02301897|144777761|SUPERIORITY|||||||0.0653|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Week 18 Course 1||||0.0653
72623494|NCT02301897|144777761|SUPERIORITY|||||||0.048|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Week 18 Course 1||||0.0480
72623495|NCT02301897|144777761|SUPERIORITY|||||||0.401|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to On-Drug Course 2||||0.4010
72623496|NCT02301897|144777761|SUPERIORITY|||||||0.0772|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to On-Drug Course 2||||0.0772
72623497|NCT02301897|144777761|SUPERIORITY|||||||0.3206|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Week 18 Course 2||||0.3206
72623498|NCT02301897|144777761|SUPERIORITY|||||||0.1605|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Week 18 Course 2||||0.1605
72623499|NCT02301897|144777761|SUPERIORITY|||||||0.557|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Course 2 Week 24 FU||||0.5570
72623500|NCT02301897|144777761|SUPERIORITY|||||||0.3437|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Course 2 Week 24 FU||||0.3437
72623501|NCT02301897|144777762|SUPERIORITY|||||||0.2624|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Week 18 Course 1||||0.2624
72623502|NCT02301897|144777762|SUPERIORITY|||||||0.0688|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Week 18 Course 1||||0.0688
72623503|NCT02301897|144777762|SUPERIORITY|||||||0.279|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to On-Drug Course 2||||0.2790
72623504|NCT02301897|144777762|SUPERIORITY|||||||0.6541|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to On-Drug Course 2||||0.6541
72623505|NCT02301897|144777762|SUPERIORITY|||||||0.8559|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Week 18 Course 2||||0.8559
72623506|NCT02301897|144777762|SUPERIORITY|||||||0.4326|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Week 18 Course 2||||0.4326
72623507|NCT02301897|144777762|SUPERIORITY|||||||0.1052|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Course 2 Week 24 FU||||0.1052
72623508|NCT02301897|144777762|SUPERIORITY|||||||0.9206|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Course 2 Week 24 FU||||0.9206
72623509|NCT02301897|144777763|SUPERIORITY|||||||0.1439|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Week 18 Course 1||||0.1439
72623510|NCT02301897|144777763|SUPERIORITY|||||||0.067|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Week 18 Course 1||||0.0670
72623511|NCT02301897|144777763|SUPERIORITY|||||||0.6761|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to On-Drug Course 2||||0.6761
72623512|NCT02301897|144777763|SUPERIORITY|||||||0.0639|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to On-Drug Course 2||||0.0639
72623513|NCT02301897|144777763|SUPERIORITY|||||||0.2218|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Week 18 Course 2||||0.2218
72623514|NCT02301897|144777763|SUPERIORITY|||||||0.4468|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Week 18 Course 2||||0.4468
72478739|NCT00910689|144483311|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.1|STANDARD_DEVIATION|2.83|>|0.03||95.0||||Bonferoni adjusted critical value p = .0083.|t-test, 2 sided|Degrees of freedom = 1 and 106.||Post-test contrast. Mean difference in change.||||>0.03
72478740|NCT02349425|144483340|SUPERIORITY||Estimated percent change|-41.222||||0.0055|TWO_SIDED|95.0|-59.294|-15.127|||Mixed Models Analysis|Per protocol, statistical analysis follows a Mixed Model which uses log-transformation|Percent change difference between Gefapixant and placebo was estimated by 100 x \[e\^diff - 1\] where e=exponent of difference; and diff = the treatment mean difference from mixed model of change from baseline based on log-transformed data.|||-15.127|-59.294|0.0055
72478741|NCT02349425|144483340|SUPERIORITY||Estimated percent change|-51.973||||0.0008|TWO_SIDED|95.0|-68.23|-27.397|||Mixed Models Analysis|Per protocol, statistical analysis follows a Mixed Model which uses log-transformation.|Percent change difference between Gefapixant and placebo was estimated by 100 x \[e\^diff - 1\] where e=exponent of difference; and diff = the treatment mean difference from mixed model of change from baseline based on log-transformed data.|||-27.397|-68.230|0.0008
72509157|NCT00431847|144548624|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1004|STANDARD_ERROR_OF_MEAN|0.2746||0.7148|TWO_SIDED|95.0|-0.6404|0.4396|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.||0.4396|-0.6404|0.7148
72478742|NCT02349425|144483340|SUPERIORITY||Estimated percent change|-46.853||||0.0075|TWO_SIDED|95.0|-66.291|-16.206|||Mixed Models Analysis|Per protocol, statistical analysis follows a Mixed Model which uses log-transformation.|Percent change difference between Gefapixant and placebo was estimated by 100 x \[e\^diff - 1\] where e=exponent of difference; and diff = the treatment mean difference from mixed model of change from baseline based on log-transformed data.|||-16.206|-66.291|0.0075
72509158|NCT00431847|144548624|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.3568|STANDARD_ERROR_OF_MEAN|0.4009||0.3741|TWO_SIDED|95.0|-0.4318|1.1453|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.||1.1453|-0.4318|0.3741
72509159|NCT00431847|144548624|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.2969|STANDARD_ERROR_OF_MEAN|0.5609||0.0213|TWO_SIDED|95.0|0.1938|2.4|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.||2.4000|0.1938|0.0213
72509160|NCT00431847|144548625|SUPERIORITY_OR_OTHER||Slope|-0.02776|STANDARD_ERROR_OF_MEAN|0.004706|<|0.0001|TWO_SIDED|95.0|-0.03702|-0.0185|||Mixed Models Analysis|||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group. The overall slope of the model (below) is reported as a continuous variable for time since injury.||-0.01850|-0.03702|<0.0001
72509161|NCT00431847|144548625|SUPERIORITY_OR_OTHER||Chi-Squared|3.88||||0.2752|TWO_SIDED||||||Chi-squared|Degrees of Freedom: 3||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The time interaction component of the model is reported below.||||0.2752
72509162|NCT00431847|144548625|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.3079|STANDARD_ERROR_OF_MEAN|0.1918||0.1094|TWO_SIDED|95.0|-0.6851|0.06941|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.||0.06941|-0.6851|0.1094
72509163|NCT00431847|144548625|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0428|STANDARD_ERROR_OF_MEAN|0.28||0.8786|TWO_SIDED|95.0|-0.5079|0.5935|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.||0.5935|-0.5079|0.8786
72509164|NCT00431847|144548625|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.6759|STANDARD_ERROR_OF_MEAN|0.391||0.0847|TWO_SIDED|95.0|-0.09297|1.4448|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.||1.4448|-0.09297|0.0847
72509165|NCT00431847|144548626|SUPERIORITY_OR_OTHER||Slope|-0.03645|STANDARD_ERROR_OF_MEAN|0.005913|<|0.0001|TWO_SIDED|95.0|-0.04808|-0.02481|||Mixed Models Analysis|||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group. The overall slope of the model (below) is reported as a continuous variable for time since injury.||-0.02481|-0.04808|<0.0001
72509166|NCT00431847|144548626|SUPERIORITY_OR_OTHER||Chi-Squared|3.16||||0.3677|TWO_SIDED||||||Chi-squared|Degrees of Freedom: 3||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The time interaction component of the model is reported below.||||0.3677
72623515|NCT02301897|144777763|SUPERIORITY|||||||0.7678|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Course 2 Week 24 FU||||0.7678
72478743|NCT02349425|144483340|SUPERIORITY||Estimated percent change|-57.067||||0.0009|TWO_SIDED|95.0|-73.375|-30.771|||Mixed Models Analysis|Per protocol, statistical analysis follows a Mixed Model which uses log-transformation.|Percent change difference between Gefapixant and placebo was estimated by 100 x \[e\^diff - 1\] where e=exponent of difference; and diff = the treatment mean difference from mixed model of change from baseline based on log-transformed data.|||-30.771|-73.375|0.0009
72478744|NCT02349425|144483341|SUPERIORITY||Estimated percent change|-14.691||||0.2542|TWO_SIDED|95.0|-35.307|12.493|||Mixed Models Analysis|Per protocol, statistical analysis follows a Mixed Model which uses log-transformation.|Percent change difference between Gefapixant and placebo was estimated by 100 x \[e\^diff - 1\] where e=exponent of difference; and diff = the treatment mean difference from mixed model of change from baseline based on log-transformed data.|||12.493|-35.307|0.2542
72478745|NCT02349425|144483341|SUPERIORITY||Estimated percent change|-25.165||||0.0267|TWO_SIDED|95.0|-42.014|-3.421|||Mixed Models Analysis|Per protocol, statistical analysis follows a Mixed Model which uses log-transformation.|Percent change difference between Gefapixant and placebo was estimated by 100 x \[e\^diff - 1\] where e=exponent of difference; and diff = the treatment mean difference from mixed model of change from baseline based on log-transformed data.|||-3.4210|-42.014|0.0267
72623516|NCT02301897|144777763|SUPERIORITY|||||||0.8922|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Course 2 Week 24 FU||||0.8922
72623517|NCT02301897|144777764|SUPERIORITY|||||||0.1262|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Week 18 Course 1||||0.1262
72509167|NCT00431847|144548626|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.05816|STANDARD_ERROR_OF_MEAN|0.221||0.7926|TWO_SIDED|95.0|-0.4929|0.3766|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.||0.3766|-0.4929|0.7926
72509168|NCT00431847|144548626|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.1708|STANDARD_ERROR_OF_MEAN|0.3212||0.5953|TWO_SIDED|95.0|-0.461|0.8026|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.||0.8026|-0.4610|0.5953
72509169|NCT00431847|144548626|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.6873|STANDARD_ERROR_OF_MEAN|0.4482||0.1261|TWO_SIDED|95.0|-0.1943|1.5689|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.||1.5689|-0.1943|0.1261
72509170|NCT00431847|144548627|SUPERIORITY_OR_OTHER||Slope|-0.4831|STANDARD_ERROR_OF_MEAN|0.1243||0.0002|TWO_SIDED|95.0|-0.7286|-0.2377|||Mixed Models Analysis|||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group. The overall slope of the model (below) is reported as a continuous variable for time since injury.||-0.2377|-0.7286|0.0002
72509171|NCT00431847|144548627|SUPERIORITY_OR_OTHER||Chi-Squared|3.2||||0.3617|TWO_SIDED||||||Chi-squared|Degrees of Freedom: 3||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The time interaction component of the model is reported below.||||0.3617
72509172|NCT00431847|144548627|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.1574|STANDARD_ERROR_OF_MEAN|2.7573||0.2532|TWO_SIDED|95.0|-2.2715|8.5863|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.||8.5863|-2.2715|0.2532
72509173|NCT00431847|144548627|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.2227|STANDARD_ERROR_OF_MEAN|3.9633||0.758|TWO_SIDED|95.0|-6.5833|9.0286|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.||9.0286|-6.5833|0.7580
72509174|NCT00431847|144548627|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-7.1649|STANDARD_ERROR_OF_MEAN|5.3759||0.1837|TWO_SIDED|95.0|-17.7484|3.4187|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.||3.4187|-17.7484|0.1837
72566504|NCT02697773|144663296|SUPERIORITY||LS Mean Ratio|1.06|STANDARD_ERROR_OF_MEAN|0.18||0.7275|TWO_SIDED|95.0|0.76|1.48|||Negative binomial model|||Week 16: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.||1.48|0.76|0.7275
72566505|NCT02697773|144663296|SUPERIORITY||LS Mean Ratio|0.94|STANDARD_ERROR_OF_MEAN|0.16||0.709|TWO_SIDED|95.0|0.67|1.31|||Negative binomial model|||Week 16: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.||1.31|0.67|0.7090
72623518|NCT02301897|144777764|SUPERIORITY|||||||0.2075|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Week 18 Course 1||||0.2075
72623519|NCT02301897|144777764|SUPERIORITY|||||||0.5904|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to On-Drug Course 2||||0.5904
72509175|NCT00431847|144548628|SUPERIORITY_OR_OTHER||Slope|0.4741|STANDARD_ERROR_OF_MEAN|0.03909|<|0.0001|TWO_SIDED|95.0|0.3971|0.5511|||Mixed Models Analysis|||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group. The overall slope of the model (below) is reported as a continuous variable for time since injury.||0.5511|0.3971|<0.0001
72478746|NCT02349425|144483341|SUPERIORITY||Estimated percent change|-37.146||||0.0198|TWO_SIDED|95.0|-57.345|-7.3821|||Mixed Models Analysis|Per protocol, statistical analysis follows a Mixed Model which uses log-transformation.|Percent change difference between Gefapixant and placebo was estimated by 100 x \[e\^diff - 1\] where e=exponent of difference; and diff = the treatment mean difference from mixed model of change from baseline based on log-transformed data.|||-7.3821|-57.345|0.0198
72478747|NCT02349425|144483341|SUPERIORITY||Estimated percent change|-55.92||||0.0006|TWO_SIDED|95.0|-71.923|-30.797|||Mixed Models Analysis|Per protocol, statistical analysis follows a Mixed Model which uses log-transformation.|Percent change difference between Gefapixant and placebo was estimated by 100 x \[e\^diff - 1\] where e=exponent of difference; and diff = the treatment mean difference from mixed model of change from baseline based on log-transformed data.|||-30.797|-71.923|0.0006
72478748|NCT02349425|144483346|SUPERIORITY||Mean Difference (Final Values)|-19.0||||0.003|TWO_SIDED|95.0|-31.2|-6.8|||Mixed Models Analysis|Per Protocol, statistical analysis follows a Mixed Model.||||-6.8|-31.2|0.003
72478749|NCT02349425|144483346|SUPERIORITY||Mean Difference (Final Values)|-24.4|||<|0.001|TWO_SIDED|95.0|-36.7|-12.1|||Mixed Models Analysis|Per Protocol, statistical analysis follows a Mixed Model.||||-12.1|-36.7|<0.001
72478750|NCT02349425|144483346|SUPERIORITY||Mean Difference (Final Values)|-29.3||||0.005|TWO_SIDED|95.0|-49.0|-9.5|||Mixed Models Analysis|Per protocol, statistical analysis follows a Mixed Model.||||-9.5|-49.0|0.005
72478751|NCT02349425|144483346|SUPERIORITY||Mean Difference (Final Values)|-29.6|||<|0.001|TWO_SIDED|95.0|-44.6|-14.7|||Mixed Models Analysis|Per Protocol, statistical analysis follows a Mixed Model.||||-14.7|-44.6|<0.001
72478752|NCT02349425|144483347|SUPERIORITY||Mean Difference (Final Values)|-6.9||||0.332|TWO_SIDED|95.0|-21.0|7.2|||Mixed Models Analysis|Per Protocol, statistical analysis follows a Mixed Model.||||7.2|-21.0|0.332
72478753|NCT02349425|144483347|SUPERIORITY||Mean Difference (Final Values)|-13.5||||0.008|TWO_SIDED|95.0|-23.3|-3.6|||Mixed Models Analysis|Per Protocol, statistical analysis follows a Mixed Model.||||-3.6|-23.3|0.008
72478754|NCT02349425|144483347|SUPERIORITY||Mean Difference (Final Values)|-30.2|||<|0.001|TWO_SIDED|95.0|-44.7|-15.7|||Mixed Models Analysis|Per Protocol, statistical analysis follows a Mixed Model.||||-15.7|-44.7|<0.001
72478755|NCT02349425|144483347|SUPERIORITY||Mean Difference (Final Values)|-26.7||||0.001|TWO_SIDED|95.0|-42.3|-11.0|||Mixed Models Analysis|Per Protocol, statistical analysis follows a Mixed Model.||||-11.0|-42.3|0.001
72478756|NCT02349425|144483348|SUPERIORITY||Mean Difference (Final Values)|-15.2|||<|0.001|TWO_SIDED|95.0|-23.5|-6.8|||Mixed Models Analysis|Per Protocol, statistical analysis follows a Mixed Model.||||-6.8|-23.5|<0.001
72478757|NCT02349425|144483348|SUPERIORITY||Mean Difference (Final Values)|-16.7|||<|0.001|TWO_SIDED|95.0|-26.1|-7.4|||Mixed Models Analysis|Per Protocol, statistical analysis follows a Mixed Model.||||-7.4|-26.1|<0.001
72478758|NCT02349425|144483348|SUPERIORITY||Mean Difference (Final Values)|-19.5||||0.002|TWO_SIDED|95.0|-31.1|-7.8|||Mixed Models Analysis|Per Protocol, statistical analysis follows a Mixed Model.||||-7.8|-31.1|0.002
72478759|NCT02349425|144483348|SUPERIORITY||Mean Difference (Final Values)|-20.5|||<|0.001|TWO_SIDED|95.0|-31.8|-9.3|||Mixed Models Analysis|Per Protocol, statistical analysis follows a Mixed Model.||||-9.3|-31.8|<0.001
72478760|NCT02349425|144483349|SUPERIORITY||Mean Difference (Final Values)|-4.1||||0.315|TWO_SIDED|95.0|-12.3|4.0|||Mixed Models Analysis|Per Protocol, statistical analysis follows a Mixed Model.||||4.0|-12.3|0.315
72478761|NCT02349425|144483349|SUPERIORITY||Mean Difference (Final Values)|-7.2||||0.03|TWO_SIDED|95.0|-13.7|-0.7|||Mixed Models Analysis|Per Protocol, statistical analysis follows a Mixed Model.||||-0.7|-13.7|0.030
72478762|NCT02349425|144483349|SUPERIORITY||Mean Difference (Final Values)|-18.2|||<|0.001|TWO_SIDED|95.0|-27.4|-9.1|||Mixed Models Analysis|Per Protocol, statistical analysis follows a Mixed Model.||||-9.1|-27.4|<0.001
72478763|NCT02349425|144483349|SUPERIORITY||Mean Difference (Final Values)|-17.6|||<|0.001|TWO_SIDED|95.0|-26.3|-9.0|||Mixed Models Analysis|Per Protocol, statistical analysis follows a Mixed Model.||||-9.0|-26.3|<0.001
72478764|NCT02349425|144483350|SUPERIORITY||Mean Difference (Final Values)|-3.5||||0.169|TWO_SIDED|95.0|-8.6|1.6|||Mixed Models Analysis|Per Protocol, statistical analysis follows a Mixed Model.||||1.6|-8.6|0.169
72478765|NCT02349425|144483350|SUPERIORITY||Mean Difference (Final Values)|-2.4||||0.341|TWO_SIDED|95.0|-7.5|2.6|||Mixed Models Analysis|Per Protocol, statistical analysis follows a Mixed Model.||||2.6|-7.5|0.341
72478766|NCT02349425|144483350|SUPERIORITY||Mean Difference (Final Values)|-2.0||||0.311|TWO_SIDED|95.0|-5.8|1.9|||Mixed Models Analysis|Per Protocol, statistical analysis follows a Mixed Model.||||1.9|-5.8|0.311
72478767|NCT02349425|144483350|SUPERIORITY||Mean Difference (Final Values)|-3.7||||0.128|TWO_SIDED|95.0|-8.6|1.1|||Mixed Models Analysis|Per Protocol, statistical analysis follows a Mixed Model.||||1.1|-8.6|0.128
72478768|NCT02349425|144483351|SUPERIORITY||Mean Difference (Final Values)|1.2||||0.613|TWO_SIDED|95.0|-3.5|5.9|||Mixed Models Analysis|Per Protocol, statistical analysis follows a Mixed Model.||||5.9|-3.5|0.613
72478769|NCT02349425|144483351|SUPERIORITY||Mean Difference (Final Values)|-0.6||||0.743|TWO_SIDED|95.0|-4.3|3.1|||Mixed Models Analysis|Per Protocol, statistical analysis follows a Mixed Model.||||3.1|-4.3|.743
72478770|NCT02349425|144483351|SUPERIORITY||Mean Difference (Final Values)|-0.9||||0.589|TWO_SIDED|95.0|-4.1|2.3|||Mixed Models Analysis|Per Protocol, statistical analysis follows a Mixed Model.||||2.3|-4.1|0.589
72478771|NCT02349425|144483351|SUPERIORITY||Mean Difference (Final Values)|-5.1||||0.205|TWO_SIDED|95.0|-13.2|2.9|||Mixed Models Analysis|Per Protocol, statistical analysis follows a Mixed Model.||||2.9|-13.2|0.205
72478772|NCT02349425|144483352|SUPERIORITY||Mean Difference (Final Values)|-0.6||||0.0811|TWO_SIDED|95.0|-1.4|0.1|||Mixed Models Analysis|Per Protocol, statistical analysis follows a Mixed Model.||||0.1|-1.4|0.0811
72478773|NCT02349425|144483352|SUPERIORITY||Mean Difference (Final Values)|-1.3||||0.0097|TWO_SIDED|95.0|-2.2|-0.3|||Mixed Models Analysis|Per Protocol, statistical analysis follows a Mixed Model.||||-0.3|-2.2|0.0097
72400046|NCT03255382|144307942|OTHER||Least Squares Mean Difference|1.146|||<|0.001|TWO_SIDED|95.0|0.764|1.528|||ANCOVA|||P-values were calculated using ANCOVA with strata (phototherapy \[yes/no\]), baseline value, and treatment in the model.||1.528|0.764|< 0.001
72623520|NCT02301897|144777764|SUPERIORITY|||||||0.243|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to On-Drug Course 2||||0.2430
72623521|NCT02301897|144777764|SUPERIORITY|||||||0.7067|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Week 18 Course 2||||0.7067
72623522|NCT02301897|144777764|SUPERIORITY|||||||0.2725|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Week 18 Course 2||||0.2725
72623523|NCT02301897|144777764|SUPERIORITY|||||||0.7016|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Course 2 Week 24 FU||||0.7016
72623524|NCT02301897|144777764|SUPERIORITY|||||||0.8751|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Course 2 Week 24 FU||||0.8751
72623525|NCT02301897|144777765|SUPERIORITY|||||||0.0338|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Week 18 Course 1||||0.0338
72478774|NCT02349425|144483352|SUPERIORITY||Mean Difference (Final Values)|-1.6||||0.0025|TWO_SIDED|95.0|-2.6|-0.6|||Mixed Models Analysis|Per Protocol, statistical analysis follows a Mixed Model.||||-0.6|-2.6|0.0025
72478775|NCT02349425|144483352|SUPERIORITY||Mean Difference (Final Values)|-1.7||||0.005|TWO_SIDED|95.0|-2.8|-0.5|||Mixed Models Analysis|Per Protocol, statistical analysis follows a Mixed Model.||||-0.5|-2.8|0.0050
72478776|NCT02349425|144483353|SUPERIORITY||Mean Difference (Final Values)|-0.7||||0.0506|TWO_SIDED|95.0|-1.4|0.0|||Mixed Models Analysis|Per Protocol, statistical analysis follows a Mixed Model.||||0.0|-1.4|0.0506
72478777|NCT02349425|144483353|SUPERIORITY||Mean Difference (Final Values)|-0.9||||0.0447|TWO_SIDED|95.0|-1.7|0.0|||Mixed Models Analysis|Per Protocol, statistical analysis follows a Mixed Model.||||-0.0|-1.7|0.0447
72478778|NCT02349425|144483353|SUPERIORITY||Mean Difference (Final Values)|-1.3||||0.0026|TWO_SIDED|95.0|-2.2|-0.5|||Mixed Models Analysis|Per Protocol, statistical analysis follows a Mixed Model.||||-0.5|-2.2|0.0026
72623526|NCT02301897|144777765|SUPERIORITY|||||||0.0004|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Week 18 Course 1||||0.0004
72623527|NCT02301897|144777765|SUPERIORITY|||||||0.0807|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to On-Drug Course 2||||0.0807
72623528|NCT02301897|144777765|SUPERIORITY|||||||0.0142|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to On-Drug Course 2||||0.0142
72623529|NCT02301897|144777765|SUPERIORITY|||||||0.0807|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Week 18 Course 2||||0.0807
72478779|NCT02349425|144483353|SUPERIORITY||Mean Difference (Final Values)|-1.1||||0.0405|TWO_SIDED|95.0|-2.2|0.0|||Mixed Models Analysis|Per Protocol, statistical analysis follows a Mixed Model.||||-0.0|-2.2|0.0405
72478780|NCT02349425|144483354|SUPERIORITY||Mean Difference (Final Values)|3.84|||<|0.001|TWO_SIDED|95.0|1.88|5.8|||Mixed Models Analysis|Per Protocol, statistical analysis follows a Mixed Model.||||5.80|1.88|<0.001
72478781|NCT02349425|144483354|SUPERIORITY||Mean Difference (Final Values)|3.52|||<|0.001|TWO_SIDED|95.0|1.66|5.38|||Mixed Models Analysis|Per Protocol, statistical analysis follows a Mixed Model.||||5.38|1.66|<0.001
72623530|NCT02301897|144777765|SUPERIORITY|||||||0.0142|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Week 18 Course 2||||0.0142
72400047|NCT03255382|144307943|OTHER||Least Squares Mean Difference|1.32|||<|0.001|TWO_SIDED|95.0|0.936|1.704|||ANCOVA|||P-values were calculated using ANCOVA with strata (phototherapy \[yes/no\]), baseline value, and treatment in the model.||1.704|0.936|< 0.001
72478782|NCT02349425|144483355|SUPERIORITY||Mean Difference (Final Values)|-10.6||||0.096|TWO_SIDED|95.0|-23.2|1.9|||Mixed Models Analysis|Per Protocol, statistical analysis follows a Mixed Model.||||1.9|-23.2|0.096
72478783|NCT02349425|144483355|SUPERIORITY||Mean Difference (Final Values)|-20.0||||0.005|TWO_SIDED|95.0|-33.6|-6.3|||Mixed Models Analysis|Per Protocol, statistical analysis follows a Mixed Model.||||-6.3|-33.6|0.005
72478784|NCT02349425|144483355|SUPERIORITY||Mean Difference (Final Values)|-26.1|||<|0.001|TWO_SIDED|95.0|-40.7|-11.6|||Mixed Models Analysis|Per Protocol, statistical analysis follows a Mixed Model.||||-11.6|-40.7|<0.001
72478785|NCT02349425|144483355|SUPERIORITY||Mean Difference (Final Values)|-33.8|||<|0.001|TWO_SIDED|95.0|-48.4|-19.1|||Mixed Models Analysis|Per Protocol, statistical analysis follows a Mixed Model.||||-19.1|-48.4|<0.001
72478786|NCT02349425|144483356|SUPERIORITY||Mean Difference (Final Values)|-6.4||||0.311|TWO_SIDED|95.0|-19.1|6.2|||Mixed Models Analysis|Per Protocol, statistical analysis follows a Mixed Model.||||6.2|-19.1|0.311
72478787|NCT02349425|144483356|SUPERIORITY||Mean Difference (Final Values)|-7.4||||0.232|TWO_SIDED|95.0|-19.7|4.9|||Mixed Models Analysis|Per Protocol, statistical analysis follows a Mixed Model.||||4.9|-19.7|0.232
72623531|NCT02301897|144777765|SUPERIORITY|||||||0.1859|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Course 2 Off-drug||||0.1859
72623532|NCT02301897|144777765|SUPERIORITY|||||||0.0896|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Course 2 Off-drug||||0.0896
72623533|NCT03895372|144777796|SUPERIORITY||Risk Difference (RD)|8.87||||0.2621|TWO_SIDED|90.0|-4.5|26.26||One-sided Hochberg p-value, significant level is 0.05.|Chan and Zhang method|||The analysis was based on the data at Week 16.||26.26|-4.50|0.2621
72623534|NCT03895372|144777796|SUPERIORITY||Risk Difference (RD)|4.76||||0.2621|TWO_SIDED|90.0|-7.07|21.48||One-sided Hochberg p-value, significant level is 0.05.|Chan and Zhang method|||The analysis was based on the data at Week 16.||21.48|-7.07|0.2621
72623535|NCT03895372|144777796|SUPERIORITY||Risk Difference (RD)|33.02||||0.0004|TWO_SIDED|90.0|18.01|47.11||One-sided Hochberg p-value, significant level is 0.05.|Chan and Zhang method|||The analysis was based on the data at Week 16.||47.11|18.01|0.0004
72623536|NCT03895372|144777796|SUPERIORITY||Risk Difference (RD)|46.46|||<|0.0001|TWO_SIDED|90.0|30.62|60.56||One-sided Hochberg p-value, significant level is 0.05.|Chan and Zhang method|||The analysis was based on the data at Week 16.||60.56|30.62|<0.0001
72623537|NCT03895372|144777804|SUPERIORITY||Risk Difference (RD)|3.9|||||TWO_SIDED|90.0|-11.82|23.42||||||The analysis was based on the data at Week 16.||23.42|-11.82|
72623538|NCT03895372|144777804|SUPERIORITY||Risk Difference (RD)|-4.76|||||TWO_SIDED|90.0|-18.61|13.29||||||The analysis was based on the data at Week 16.||13.29|-18.61|
72623539|NCT03895372|144777804|SUPERIORITY||Risk Difference (RD)|32.38|||||TWO_SIDED|90.0|14.32|47.52||||||The analysis was based on the data at Week 16.||47.52|14.32|
72623540|NCT03895372|144777804|SUPERIORITY||Risk Difference (RD)|58.89|||||TWO_SIDED|90.0|41.01|72.41||||||The analysis was based on the data at Week 16.||72.41|41.01|
72623541|NCT03895372|144777805|SUPERIORITY||Risk Difference (RD)|1.52|||||TWO_SIDED|90.0|-14.52|20.77||||||The analysis was based on the data at Week 16.||20.77|-14.52|
72400048|NCT03255382|144307944|OTHER||Least Squares Mean Difference|-2.3|STANDARD_ERROR_OF_MEAN|0.63|<|0.001|TWO_SIDED|95.0|-3.6|-1.1|||ANCOVA|||P-values were calculated using ANCOVA with strata (phototherapy \[yes/no\]), baseline value, and treatment in the model.||-1.1|-3.6|< 0.001
72400049|NCT03255382|144307945|OTHER||Least Squares Mean Difference|-3.0|STANDARD_ERROR_OF_MEAN|0.66|<|0.001|TWO_SIDED|95.0|-4.3|-1.6|||ANCOVA|||P-values were calculated using ANCOVA with strata (phototherapy \[yes/no\]), baseline value, and treatment in the model.||-1.6|-4.3|< 0.001
72400050|NCT03255382|144307946|OTHER||Least Squares Mean Difference|-0.29|STANDARD_ERROR_OF_MEAN|0.307||0.352|TWO_SIDED|95.0|-0.9|0.32|||ANCOVA|||P-values were calculated using ANCOVA with strata (phototherapy \[yes/no\]), baseline value, and treatment in the model.||0.32|-0.90|0.352
72400051|NCT03255382|144307947|OTHER||Least Squares Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.296||0.315|TWO_SIDED|95.0|-0.88|0.29|||ANCOVA|||P-values were calculated using ANCOVA with strata (phototherapy \[yes/no\]), baseline value, and treatment in the model.||0.29|-0.88|0.315
72478788|NCT02349425|144483356|SUPERIORITY||Mean Difference (Final Values)|-15.6||||0.012|TWO_SIDED|95.0|-27.6|-3.6|||Mixed Models Analysis|Per Protocol, statistical analysis follows a Mixed Model.||||-3.6|-27.6|0.012
72478789|NCT02349425|144483356|SUPERIORITY||Mean Difference (Final Values)|-15.4||||0.043|TWO_SIDED|95.0|-30.4|-0.5|||Mixed Models Analysis|Per Protocol, statistical analysis follows a Mixed Model.||||-0.5|-30.4|0.043
72478790|NCT02915302|144483364|NON_INFERIORITY|Non-inferiority was demonstrated if the upper limit of the 2-sided 95% confidence interval (CI) of the difference in fever rate was \<5%.|Difference in Fever Rate|0.84|||||TWO_SIDED|95.0|-2.13|3.8|||||Fever rate: Fluzone Quadrivalent vaccine (0.5-mL vs. 0.25-mL)|Difference in fever rate was defined as the fever rate following a 0.5-mL dose of Fluzone Quadrivalent vaccine minus the fever rate following a 0.25-mL dose of Fluzone Quadrivalent vaccine.||3.80|-2.13|
72478791|NCT02915302|144483365|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the ratio of GMTs was \>0.667.|GMTs Ratio (A/H1N1)|1.45|||||TWO_SIDED|95.0|1.19|1.77|||||A/H1N1 strain: Fluzone Quadrivalent Vaccine (0.5-mL vs. 0.25-mL)|For A/H1N1 strain, GMT ratio was defined as the GMT after 0.5 mL dose(s) of Fluzone Quadrivalent vaccine divided by the GMT after 0.25 mL dose(s) of Fluzone Quadrivalent vaccine.||1.77|1.19|
72509176|NCT00431847|144548628|SUPERIORITY_OR_OTHER||Chi-Squared|1.83||||0.6075|TWO_SIDED||||||Chi-squared|Degrees of Freedom: 3||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The time interaction component of the model is reported below.||||0.6075
72400052|NCT03255382|144307948|OTHER||Least Squares Mean Difference|-4.8|STANDARD_ERROR_OF_MEAN|1.06|<|0.001|TWO_SIDED|95.0|-6.9|-2.7|||ANCOVA|||P-values were calculated using ANCOVA with strata (phototherapy \[yes/no\]), baseline value, and treatment in the model.||-2.7|-6.9|< 0.001
72400053|NCT03255382|144307949|OTHER||Least Squares Mean Difference|-9.3|STANDARD_ERROR_OF_MEAN|1.64|<|0.001|TWO_SIDED|95.0|-12.6|-6.1|||ANCOVA|||P-values were calculated using ANCOVA with strata (phototherapy \[yes/no\]), baseline value, and treatment in the model.||-6.1|-12.6|< 0.001
72478792|NCT02915302|144483365|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the ratio of GMTs was \>0.667.|GMTs Ratio (A/H3N2)|1.5|||||TWO_SIDED|95.0|1.23|1.83|||||A/H3N2 strain: Fluzone Quadrivalent Vaccine (0.5-mL vs. 0.25-mL)|For A/H3N2 strain, GMT ratio was defined as the GMT after 0.5 mL dose(s) of Fluzone Quadrivalent vaccine divided by the GMT after 0.25 mL dose(s) of Fluzone Quadrivalent vaccine.||1.83|1.23|
72478793|NCT02915302|144483365|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the ratio of GMTs was \>0.667.|GMTs Ratio (B Victoria lineage)|1.33|||||TWO_SIDED|95.0|1.1|1.62|||||B Victoria lineage strain: Fluzone Quadrivalent Vaccine (0.5-mL vs. 0.25-mL)|For B Victoria lineage strain, GMT ratio was defined as the GMT after 0.5 mL dose(s) of Fluzone Quadrivalent vaccine divided by the GMT after 0.25 mL dose(s) of Fluzone Quadrivalent vaccine.||1.62|1.10|
72400054|NCT03255382|144307950|OTHER||Least Squares Mean Difference|-10.2|STANDARD_ERROR_OF_MEAN|1.51|<|0.001|TWO_SIDED|95.0|-13.2|-7.2|||ANCOVA|||P-values were calculated using ANCOVA with strata (phototherapy \[yes/no\]), baseline value, and treatment in the model.||-7.2|-13.2|< 0.001
72400055|NCT03255382|144307951|OTHER||Least Squares Mean Difference|-9.8|STANDARD_ERROR_OF_MEAN|1.51|<|0.001|TWO_SIDED|95.0|-12.8|-6.8|||ANCOVA|||P-values were calculated using ANCOVA with strata (phototherapy \[yes/no\]), baseline value, and treatment in the model.||-6.8|-12.8|< 0.001
72400056|NCT03255382|144307952|OTHER||Least Squares Mean Difference|-9.6|STANDARD_ERROR_OF_MEAN|1.39|<|0.001|TWO_SIDED|95.0|-12.4|-6.8|||ANCOVA|||P-values were calculated using ANCOVA with strata (phototherapy \[yes/no\]), baseline value, and treatment in the model.||-6.8|-12.4|< 0.001
72400057|NCT03255382|144307953|OTHER||Least Squares Mean Difference|-10.0|STANDARD_ERROR_OF_MEAN|1.47|<|0.001|TWO_SIDED|95.0|-12.9|-7.1|||ANCOVA|||P-values were calculated using ANCOVA with strata (phototherapy \[yes/no\]), baseline value, and treatment in the model.||-7.1|-12.9|< 0.001
72400058|NCT03255382|144307954|OTHER||Least Squares Mean Difference|4.49|STANDARD_ERROR_OF_MEAN|1.385||0.002|TWO_SIDED|95.0|1.74|7.23|||ANCOVA|||P-values were calculated using ANCOVA with strata (phototherapy \[yes/no\]), baseline value, and treatment in the model.||7.23|1.74|0.002
72400059|NCT03255382|144307955|OTHER||Least Squares Mean Difference|4.63|STANDARD_ERROR_OF_MEAN|1.322|<|0.001|TWO_SIDED|95.0|2.01|7.25|||ANCOVA|||P-values were calculated using ANCOVA with strata (phototherapy \[yes/no\]), baseline value, and treatment in the model.||7.25|2.01|< 0.001
72400060|NCT03255382|144307956|OTHER||Least Squares Mean Difference|6.66|STANDARD_ERROR_OF_MEAN|1.787|<|0.001|TWO_SIDED|95.0|3.11|10.2|||ANCOVA|||P-values were calculated using ANCOVA with strata (phototherapy \[yes/no\]), baseline value, and treatment in the model.||10.20|3.11|< 0.001
72566506|NCT02697773|144663298|SUPERIORITY||LS Mean Ratio|0.97|STANDARD_ERROR_OF_MEAN|0.25||0.9164|TWO_SIDED|95.0|0.58|1.62|||Negative binomial model|||Week 2: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.||1.62|0.58|0.9164
72566507|NCT02697773|144663298|SUPERIORITY|Week 2: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.|LS Mean Ratio|0.79|STANDARD_ERROR_OF_MEAN|0.2||0.3542|TWO_SIDED|95.0|0.47|1.31|||Negative binomial model|||||1.31|0.47|0.3542
72400061|NCT03255382|144307957|OTHER||Least Squares Mean Difference|7.85|STANDARD_ERROR_OF_MEAN|1.784|<|0.001|TWO_SIDED|95.0|4.31|11.38|||ANCOVA|||P-values were calculated using ANCOVA with strata (phototherapy \[yes/no\]), baseline value, and treatment in the model.||11.38|4.31|< 0.001
72400062|NCT03255382|144307958|OTHER||Least Squares Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.13|<|0.001|TWO_SIDED|95.0|-1.2|-0.7|||ANCOVA|||P-values were calculated using ANCOVA with strata (phototherapy \[yes/no\]), baseline value, and treatment in the model.||-0.7|-1.2|< 0.001
72400063|NCT03255382|144307959|OTHER||Least Squares Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.13|<|0.001|TWO_SIDED|95.0|-1.3|-0.8|||ANCOVA|||P-values were calculated using ANCOVA with strata (phototherapy \[yes/no\]), baseline value, and treatment in the model.||-0.8|-1.3|< 0.001
72400064|NCT03255382|144307960|OTHER||Least Squares Mean Difference|-2.0|STANDARD_ERROR_OF_MEAN|0.57|<|0.001|TWO_SIDED|95.0|-3.2|-0.9|||ANCOVA|||P-values were calculated using ANCOVA with strata (phototherapy \[yes/no\]), baseline value, and treatment in the model.||-0.9|-3.2|< 0.001
72400065|NCT03255382|144307961|OTHER||Least Squares Mean Difference|-2.3|STANDARD_ERROR_OF_MEAN|0.59|<|0.001|TWO_SIDED|95.0|-3.5|-1.1|||ANCOVA|||P-values were calculated using ANCOVA with strata (phototherapy \[yes/no\]), baseline value, and treatment in the model.||-1.1|-3.5|< 0.001
72400066|NCT03255382|144307962|OTHER||Least Squares Mean Difference|-3.1|STANDARD_ERROR_OF_MEAN|0.61|<|0.001|TWO_SIDED|95.0|-4.3|-1.9|||ANCOVA|||P-values were calculated using ANCOVA with strata (phototherapy \[yes/no\]), baseline value, and treatment in the model.||-1.9|-4.3|< 0.001
72478794|NCT02915302|144483365|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the ratio of GMTs was \>0.667.|GMTs Ratio (B Yamagata lineage)|1.44|||||TWO_SIDED|95.0|1.2|1.73|||||B Yamagata lineage strain: Fluzone Quadrivalent Vaccine (0.5-mL vs. 0.25-mL)|For B Yamagata lineage strain, GMT ratio was defined as the GMT after 0.5 mL dose(s) of Fluzone Quadrivalent vaccine divided by the GMT after 0.25 mL dose(s) of Fluzone Quadrivalent vaccine.||1.73|1.20|
72478795|NCT02915302|144483366|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference in SCRs was \>-10%.|Difference in SCR (A/H1N1)|5.1|||||TWO_SIDED|95.0|0.189|10.0|||||A/H1N1 strain: Fluzone Quadrivalent Vaccine (0.5-mL vs. 0.25-mL)|For A/H1N1 strain, difference in SCR was defined as SCR after 0.5-mL dose(s) of Fluzone Quadrivalent Vaccine minus SCR after 0.25-mL dose(s) of Fluzone Quadrivalent Vaccine.||10.0|0.189|
72400067|NCT03255382|144307963|OTHER||Least Squares Mean Difference|-3.1|STANDARD_ERROR_OF_MEAN|0.65|<|0.001|TWO_SIDED|95.0|-4.4|-1.8|||ANCOVA|||P-values were calculated using ANCOVA with strata (phototherapy \[yes/no\]), baseline value, and treatment in the model.||-1.8|-4.4|< 0.001
72478796|NCT02915302|144483366|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference in SCRs was \>-10%.|Difference in SCR (A/H3N2)|4.3|||||TWO_SIDED|95.0|-0.283|8.99|||||A/H3N2 strain: Fluzone Quadrivalent Vaccine (0.5-mL vs. 0.25-mL)|For A/H3N2 strain, difference in SCR was defined as SCR after 0.5-mL dose(s) of Fluzone Quadrivalent Vaccine minus SCR after 0.25-mL dose(s) of Fluzone Quadrivalent Vaccine.||8.99|-0.283|
72478797|NCT02915302|144483366|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference in SCRs was \>-10%.|Difference in SCR (B Victoria lineage)|1.4|||||TWO_SIDED|95.0|-2.78|5.56|||||B Victoria lineage strain: Fluzone Quadrivalent Vaccine (0.5-mL vs. 0.25-mL)|For B Victoria lineage strain, difference in SCR was defined as SCR after 0.5-mL dose(s) of Fluzone Quadrivalent Vaccine minus SCR after 0.25-mL dose(s) of Fluzone Quadrivalent Vaccine.||5.56|-2.78|
72478798|NCT02915302|144483366|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference in SCRs was \>-10%.|Difference in SCR (B Yamagata lineage)|3.4|||||TWO_SIDED|95.0|-0.465|7.36|||||B Yamagata lineage strain: Fluzone Quadrivalent Vaccine (0.5-mL vs. 0.25-mL)|For B Yamagata lineage strain, difference in SCR was defined as SCR after 0.5-mL dose(s) of Fluzone Quadrivalent Vaccine minus SCR after 0.25-mL dose(s) of Fluzone Quadrivalent Vaccine.||7.36|-0.465|
72478799|NCT00645801|144483370|SUPERIORITY|||||||0.05||||||A 2-sided 2 sample t test was used to compare the overall cleanliness score between the 2 treatment groups.|t-test, 2 sided|||Based on the assumption that 70% of patients using PEG plus placebo (group 2) will have good results, by allocating 100 cases in each group, we will have 84% power to detect a difference of 18% or more in the effectiveness of PEG plus lubiprostone combination (group 1) (eg, 70% in group 2 vs. 88% in group 1) at the alpha level of significancelevel of significance.||||0.05
72478800|NCT00645801|144483371|SUPERIORITY||||||<|0.05|||||||2 sided Cochran-Armitage trend test|||||||<0.05
72400068|NCT03255382|144307964|OTHER||Adjusted percentage difference|38.3|||<|0.001|TWO_SIDED|95.0|23.6|53.1|||Cochran-Mantel-Haenszel|||P-value was calculated from the CMH test adjusted for strata (prior phototherapy \[yes/no\]).||53.1|23.6|< 0.001
72400069|NCT03255382|144307965|OTHER||Adjusted percentage difference|56.8|||<|0.001|TWO_SIDED|95.0|42.7|70.9|||Cochran-Mantel-Haenszel|||P-value was calculated from the CMH test adjusted for strata (prior phototherapy \[yes/no\]).||70.9|42.7|< 0.001
72400070|NCT03255382|144307966|OTHER||Least Squares Mean Difference|-7.4|STANDARD_ERROR_OF_MEAN|1.15|<|0.001|TWO_SIDED|95.0|-9.6|-5.1|||ANCOVA|||P-values were calculated using ANCOVA with prior phototherapy (yes/no), baseline value, and treatment in the model.||-5.1|-9.6|< 0.001
72400071|NCT03255382|144307967|OTHER||Least Squares Mean Difference|-7.6|STANDARD_ERROR_OF_MEAN|1.06|<|0.001|TWO_SIDED|95.0|-9.7|-5.5|||ANCOVA|||P-values were calculated using ANCOVA with strata (phototherapy \[yes/no\]), baseline value, and treatment in the model.||-5.5|-9.7|< 0.001
72478801|NCT00645801|144483372|SUPERIORITY||||||<|0.05|||||||ANCOVA|||||||<0.05
72400072|NCT03255382|144307968|OTHER||Least Squares Mean Difference|-6.6|STANDARD_ERROR_OF_MEAN|1.23|<|0.001|TWO_SIDED|95.0|-9.0|-4.1|||ANCOVA|||P-values were calculated using ANCOVA with strata (phototherapy \[yes/no\]), baseline value, and treatment in the model.||-4.1|-9.0|< 0.001
72400073|NCT03255382|144307969|OTHER||Least Squares Mean Difference|-8.1|STANDARD_ERROR_OF_MEAN|1.53|<|0.001|TWO_SIDED|95.0|-11.1|-5.0|||ANCOVA|||P-values were calculated using ANCOVA with strata (phototherapy \[yes/no\]), baseline value, and treatment in the model.||-5.0|-11.1|< 0.001
72400074|NCT03255382|144307970|OTHER||Least Squares Mean Difference|0.087|STANDARD_ERROR_OF_MEAN|0.0215|<|0.001|TWO_SIDED|95.0|0.045|0.13|||ANCOVA|||P-values were calculated using ANCOVA with strata (phototherapy \[yes/no\]), baseline value, and treatment in the model.||0.130|0.045|< 0.001
72623542|NCT03895372|144777805|SUPERIORITY||Risk Difference (RD)|-2.38|||||TWO_SIDED|90.0|-17.67|17.01||||||The analysis was based on the data at Week 16.||17.01|-17.67|
72478802|NCT00705679|144483376|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.85||||0.37|TWO_SIDED|95.0|0.61|1.21||The two-sided test a priori threshold for statistical significance is 0.05 against an alternative of 0% effectiveness for estimated effectiveness levels between 33.3% and 50.0%.|Regression, Cox|The Cox proportional-hazards model was stratified by site.|A ratio less than 1 indicates a lower rate of HIV infection in the active arm compared to the placebo arm. A ratio more than 1 indicates a higher rate of HIV infection in the active arm compared to the placebo arm.|The null hypothesis is that the active product will be no more than 25% effective. The trial was designed so that 94 events per pairwise comparison are needed to detect 55% effectiveness while ruling out a lower effectiveness of 25% with 90% power and a false-positive error rate of 0.0025.||1.21|0.61|0.37
72478803|NCT00705679|144483379|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.49||||0.07|TWO_SIDED|95.0|0.97|2.29||The two-sided test a priori threshold for statistical significance is 0.05 against an alternative of 0% effectiveness for estimated effectiveness levels between 33.3% and 50.0%.|Regression, Cox|The Cox proportional-hazards model was stratified by site.|A ratio less than 1 indicates a lower rate of HIV infection in the active arm compared to the placebo arm. A ratio more than 1 indicates a higher rate of HIV infection in the active arm compared to the placebo arm.|The null hypothesis is that the active product will be no more than 25% effective. The trial was designed so that 94 events per pairwise comparison are needed to detect 55% effectiveness while ruling out a lower effectiveness of 25% with 90% power and a false-positive error rate of 0.0025.||2.29|0.97|0.07
72478804|NCT00705679|144483382|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.04||||0.81|TWO_SIDED|95.0|0.73|1.49||The two-sided test a priori threshold for statistical significance is 0.05 against an alternative of 0% effectiveness for estimated effectiveness levels between 33.3% and 50.0%.|Regression, Cox|The Cox proportional-hazards model was stratified by site.|A ratio less than 1 indicates a lower rate of HIV infection in the active arm compared to the placebo arm. A ratio more than 1 indicates a higher rate of HIV infection in the active arm compared to the placebo arm.|The null hypothesis is that the active product will be no more than 25% effective. The trial was designed so that 94 events per pairwise comparison are needed to detect 55% effectiveness while ruling out a lower effectiveness of 25% with 90% power and a false-positive error rate of 0.0025.||1.49|0.73|0.81
72478805|NCT00705679|144483383|SUPERIORITY_OR_OTHER_LEGACY|||||||0.004|TWO_SIDED||||||Fisher Exact|Two-sided Fisher's Exact Test.||||||0.004
72509177|NCT00431847|144548628|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.9534|STANDARD_ERROR_OF_MEAN|1.2763||0.4558|TWO_SIDED|95.0|-3.4675|1.5607|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.||1.5607|-3.4675|0.4558
72478806|NCT00932113|144483384|OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
72478807|NCT00896051|144483399|SUPERIORITY_OR_OTHER||Least Squares (LS) Means Ratio|0.82|||||TWO_SIDED|90.0|0.55|1.22|||Linear mixed effects model|A linear mixed effects model was used controlling for treatment as fixed effect, and participant as a random effect.||Parameter: minimum plasma concentration (Cmin)||1.22|0.55|
72478808|NCT00896051|144483399|SUPERIORITY_OR_OTHER||Least Squares (LS) Mean Ratio|0.96|||||TWO_SIDED|90.0|0.8|1.16|||Linear mixed effects model|A linear mixed effects model was used controlling for treatment as fixed effect, and participant as a random effect.||Parameter: maximum plasma concentration (Cmax)||1.16|0.80|
72478809|NCT00896051|144483400|SUPERIORITY_OR_OTHER||Least Squares (LS) Means Ratio|0.96|||||TWO_SIDED|90.0|0.76|1.22|||Linear mixed effects model|linear mixed effects model was used controlling for treatment as fixed effect, and participant as a random effect.||Parameter: area under the plasma concentration-time curve from time of intake to 24 hours after dosing (AUC24hr)||1.22|0.76|
72478810|NCT00896051|144483401|SUPERIORITY_OR_OTHER||Least Squares (LS) Means Ratio|0.91|||||TWO_SIDED|90.0|0.63|1.33|||Linear mixed effects model|A linear mixed effects model was used controlling for treatment as fixed effect, and participant as a random effect.||Parameter: Minimum plasma concentration (Cmin)||1.33|0.63|
72478811|NCT00896051|144483401|SUPERIORITY_OR_OTHER||Least Squares (LS) Means Ratio|1.05|||||TWO_SIDED|90.0|0.86|1.27|||Linear mixed effects model|A linear mixed effects model was used controlling for treatment as fixed effect, and participant as a random effect.||Parameter: maximum plasma concentration (Cmax)||1.27|0.86|
72478812|NCT00896051|144483402|SUPERIORITY_OR_OTHER||Least Squares (LS) Means Ratio|0.99|||||TWO_SIDED|90.0|0.81|1.21|||Llinear mixed effects model|A linear mixed effects model was used controlling for treatment as fixed effect, and participant as a random effect.||Parameter: area under the plasma concentration-time curve from time of intake to 24 hours after dosing (AUC24hr)||1.21|0.81|
72478813|NCT00876928|144483421|SUPERIORITY_OR_OTHER||Percent of patients developing diabetes|10.0||||0.61|TWO_SIDED|95.0|8.0|12.0||A chi square test was used for the number of participants developing diabetes and a 2-way repeated measures ANOVA for the disposition index|Chi-squared||Primary outcome compared the number of participants developing diabetes after receiving vitamin D or placebo for one year. Secondary outcome compared changes in 2-way repeated measures ANOVA; therefore,no confidence intervals/dispersion parameters|Null hypothesis is that there is no effect of vitamin D on the development of diabetes in people with pre-diabetes and hypovitaminosis D. There were no published data when this trial was started on the effect of vitamin D in pre-diabetes making a power calculation difficult.||12|8|0.61
72478814|NCT00876928|144483422|SUPERIORITY_OR_OTHER|||||||0.39||95.0|||||ANOVA|||The null hypothesis is that there would be no difference in the changes in the Disposition Index between the 2 groups over the year.||||0.39
72509178|NCT00431847|144548628|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.3505|STANDARD_ERROR_OF_MEAN|1.977||0.0914|TWO_SIDED|95.0|-7.2442|0.5432|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.||0.5432|-7.2442|0.0914
72566508|NCT02697773|144663298|SUPERIORITY||LS Mean Ratio|0.93|STANDARD_ERROR_OF_MEAN|0.28||0.8065|TWO_SIDED|95.0|0.51|1.68|||Negative binomial model|||Week 4: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.||1.68|0.51|0.8065
72478815|NCT03719170|144483423|SUPERIORITY||Slope|0.0000684|||||TWO_SIDED|95.0|-0.0003|0.000413||||||"Power Calculation:~Assuming approximately the same number of eligible subjects in each VISN (with an average of 10,563 candidates per VISN) and an Intraclass correlation coefficient (ICC) of 0.12, randomizing 17 VISNs will give more than 80% power to detect % days on PPI of 75% vs. 50%, 85% vs. 60%, 80% vs. 55%, or 70% vs. 45%, but to detect a difference between 70% vs. 50%, power is only 61% using 0.05 level 2-sided test."||0.000413|-0.0003|
72478816|NCT00118755|144483424|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.89||||0.3883|TWO_SIDED|95.0|0.67|1.17|||Log Rank|||||1.17|0.67|0.3883
72478817|NCT00118755|144483425|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.85||||0.2458|TWO_SIDED|95.0|0.64|1.12|||Log Rank|||||1.12|0.64|0.2458
72478818|NCT00118755|144483426|SUPERIORITY_OR_OTHER||Difference in Response Rate|9.8||||||95.0|0.9|18.7|||||95% Wald asymptotic CI using normal approximation (continuity corrected)|||18.7|0.9|
72478819|NCT00118755|144483427|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.14||||0.6294||95.0|0.66|1.97|||Log Rank|||||1.97|0.66|0.6294
72478820|NCT01143038|144483428|SUPERIORITY_OR_OTHER_LEGACY||Mean|9.2|||||TWO_SIDED|95.0|8.3|10.1|||||Based on the t-distribution|||10.1|8.3|
72478821|NCT01143038|144483428|SUPERIORITY_OR_OTHER_LEGACY||Bootstrap mean|9.1|STANDARD_ERROR_OF_MEAN|0.4|||TWO_SIDED|95.0|8.3|10.0|||||Estimates are based on bootstrap method with 1000 samples with replacement.|Bootstrap analysis||10.0|8.3|
72566509|NCT02697773|144663298|SUPERIORITY||LS Mean Ratio|0.66|STANDARD_ERROR_OF_MEAN|0.2||0.1752|TWO_SIDED|95.0|0.36|1.2|||Negative binomial model|||Week 4: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.||1.20|0.36|0.1752
72478822|NCT01346475|144483435|SUPERIORITY_OR_OTHER||Incident Risk Ratio|0.54|||<|0.001|TWO_SIDED|95.0|0.44|0.66|||Incident risk ratio|The model is adjusted for period effects.||This study had 80% power to detect a 50% reduction in HSV genital shedding rates for high-dose valacyclovir compared to standard dose valacyclovir.||0.66|0.44|<0.001
72478823|NCT00370331|144483439|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|8.2|||<|0.001||99.0|3.59|18.73|||Repeated measures model for binary data|Repeated measures model for binary data using Generalized Estimating Equations (GEE)||||18.73|3.59|<0.001
72478824|NCT00757588|144483449|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.41|STANDARD_ERROR_OF_MEAN|0.089|<|0.0001|TWO_SIDED|95.0|-0.59|-0.24||Significance testing based on hierarchical testing. Primary and secondary endpoints are presented in order of testing.|ANCOVA|Adjusted mean difference for saxagliptin groups vs placebo in Week 24 (LOCF). Adjusted for baseline.|ANCOVA model: difference between week t and baseline values = baseline values + treatment + metformin use|||-0.24|-0.59|<0.0001
72478825|NCT00757588|144483450|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3829.8|STANDARD_ERROR_OF_MEAN|1165.99||0.0011|TWO_SIDED|95.0|-6122.4|-1537.1||Significance testing based on hierarchical testing. Primary and secondary endpoints are presented in order of testing.|ANCOVA|Adjusted mean difference for saxagliptin groups vs placebo in Week 24 (LOCF). Adjusted for baseline.|ANCOVA model: difference between week t and baseline values = baseline values + treatment + metformin use|||-1537.1|-6122.4|0.0011
72478826|NCT00757588|144483451|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-23.0|STANDARD_ERROR_OF_MEAN|7.24||0.0016|TWO_SIDED|95.0|-37.2|-8.7||Significance testing based on hierarchical testing. Primary and secondary endpoints are presented in order of testing.|ANCOVA|Adjusted mean difference for saxagliptin groups vs placebo in Week 24 (LOCF). Adjusted for baseline.|ANCOVA model: difference between week t and baseline values = baseline values + treatment + metformin use|||-8.7|-37.2|0.0016
72566510|NCT02697773|144663298|SUPERIORITY||LS Mean Ratio|0.91|STANDARD_ERROR_OF_MEAN|0.3||0.7837|TWO_SIDED|95.0|0.48|1.73|||Negative binomial model|||Week 8: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.||1.73|0.48|0.7837
72478827|NCT00757588|144483452|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.02|STANDARD_ERROR_OF_MEAN|4.732||0.3958|TWO_SIDED|95.0|-13.32|5.28||Significance testing based on hierarchical testing. Primary and secondary endpoints are presented in order of testing.|ANCOVA|Adjusted mean difference for saxagliptin groups vs placebo in Week 24 (LOCF). Adjusted for baseline.|ANCOVA model: difference between week t and baseline values = baseline values + treatment + metformin use|||5.28|-13.32|0.3958
72478828|NCT00757588|144483454|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.3|STANDARD_ERROR_OF_MEAN|1.16|||TWO_SIDED|95.0|-5.6|-1.1||Significance testing based on hierarchical testing. Primary and secondary endpoints are presented in order of testing.|ANCOVA|Adjusted mean difference for saxagliptin groups vs placebo in Week 24 (LOCF). Adjusted for baseline.|ANCOVA model: difference between week t and baseline values = baseline values + treatment + metformin use|||-1.1|-5.6|
72478829|NCT01052103|144483463|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|1.0|STANDARD_ERROR_OF_MEAN|1.6||0.732||95.0||||One-sided p-value.|Type 3 Tests|||Changes from baseline to all post-baseline visits were analyzed using a restricted maximum likelihood-based MMRM. Model terms included fixed class effects for visit, investigative site, treatment, SOC type, baseline positive symptom stratum, and treatment-by-visit interaction as well as the continuous, fixed covariates of baseline measurement and baseline-by-visit interaction.||||0.732
72478830|NCT01052103|144483464|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|2.2|STANDARD_ERROR_OF_MEAN|2.1||0.846||95.0||||One-sided p-value.|Type 3 Tests|||Changes from baseline to all post-baseline visits were analyzed using a restricted maximum likelihood-based MMRM. Model terms included fixed class effects for visit, investigative site, treatment, SOC type, baseline positive symptom stratum, and treatment-by-visit interaction as well as the continuous, fixed covariates of baseline measurement and baseline-by-visit interaction.||||0.846
72478831|NCT01052103|144483465|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|-0.1|STANDARD_ERROR_OF_MEAN|0.1||0.201||95.0||||One-sided p-value.|Type 3 Tests|||Changes from baseline to all post-baseline visits were analyzed using a restricted maximum likelihood-based MMRM. Model terms included fixed class effects for visit, investigative site, treatment, SOC type, baseline positive symptom stratum, and treatment-by-visit interaction as well as the continuous, fixed covariates of baseline measurement and baseline-by-visit interaction.||||0.201
72566511|NCT02697773|144663298|SUPERIORITY||LS Mean Ratio|0.81|STANDARD_ERROR_OF_MEAN|0.26||0.5062|TWO_SIDED|95.0|0.43|1.52|||Negative binomial model|||Week 8: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.||1.52|0.43|0.5062
72478832|NCT01052103|144483466|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|1.4|STANDARD_ERROR_OF_MEAN|1.3||0.136||95.0||||One-sided p-value.|Type 3 Tests|||Changes from baseline to all post-baseline visits were analyzed using a restricted maximum likelihood-based MMRM. Model terms included fixed class effects for visit, investigative site, treatment, SOC type, baseline positive symptom stratum, and treatment-by-visit interaction as well as the continuous, fixed covariates of baseline measurement and baseline-by-visit interaction.||||0.136
72478833|NCT01052103|144483467|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|1.5|STANDARD_ERROR_OF_MEAN|2.4||0.739||95.0||||One-sided p-value.|Type 3 Sums of Squares|||Changes from baseline to all post-baseline visits were analyzed using a restricted maximum likelihood-based MMRM. Model terms included fixed class effects for visit, investigative site, treatment, SOC type, baseline positive symptom stratum, and treatment-by-visit interaction as well as the continuous, fixed covariates of baseline measurement and baseline-by-visit interaction.||||0.739
72478834|NCT01052103|144483468|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|-0.1|STANDARD_ERROR_OF_MEAN|0.1||0.19||95.0|||||Type 3 Sums of Squares|||Changes from baseline to all post-baseline visits were analyzed using a restricted maximum likelihood-based MMRM. Model terms included fixed class effects for visit, investigative site, treatment, SOC type, baseline positive symptom stratum, and treatment-by-visit interaction as well as the continuous, fixed covariates of baseline measurement and baseline-by-visit interaction.||||0.190
72478835|NCT01052103|144483469|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|-0.1|STANDARD_ERROR_OF_MEAN|0.2||0.702||95.0|||||Type 3 Sums of Squares|||Changes from baseline to all post-baseline visits were analyzed using a restricted maximum likelihood-based MMRM. Model terms included fixed class effects for visit, investigative site, treatment, SOC type, baseline positive symptom stratum, and treatment-by-visit interaction as well as the continuous, fixed covariates of baseline measurement and baseline-by-visit interaction.||||0.702
72509179|NCT00431847|144548628|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-8.37|STANDARD_ERROR_OF_MEAN|3.0921||0.007|TWO_SIDED|95.0|-14.4589|-2.281|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.||-2.2810|-14.4589|0.007
72509180|NCT00431847|144548629|SUPERIORITY_OR_OTHER||Slope|-0.2169|STANDARD_ERROR_OF_MEAN|0.04148|<|0.0001|TWO_SIDED|95.0|-0.2987|-0.1352|||Mixed Models Analysis|||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group. The overall slope of the model (below) is reported as a continuous variable for time since injury.||-0.1352|-0.2987|<0.0001
72509181|NCT00431847|144548629|SUPERIORITY_OR_OTHER||Chi-Squared|6.37||||0.095|TWO_SIDED||||||Chi-squared|Degrees of Freedom: 3||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The time interaction component of the model is reported below.||||0.0950
72509182|NCT00431847|144548629|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.7246|STANDARD_ERROR_OF_MEAN|1.3351||0.5878|TWO_SIDED|95.0|-1.9056|3.3547|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.||3.3547|-1.9056|0.5878
72509183|NCT00431847|144548629|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.2466|STANDARD_ERROR_OF_MEAN|2.0697||0.9053|TWO_SIDED|95.0|-4.3231|3.8299|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.||3.8299|-4.3231|0.9053
72509184|NCT00431847|144548629|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.3457|STANDARD_ERROR_OF_MEAN|3.2285||0.4682|TWO_SIDED|95.0|-8.7034|4.012|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.||4.0120|-8.7034|0.4682
72509185|NCT00431847|144548630|SUPERIORITY_OR_OTHER||Slope|0.04639|STANDARD_ERROR_OF_MEAN|0.03562||0.1938|TWO_SIDED|95.0|-0.02369|0.1165|||Mixed Models Analysis|||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group. The overall slope of the model (below) is reported as a continuous variable for time since injury.||0.1165|-0.02369|0.1938
72509186|NCT00431847|144548630|SUPERIORITY_OR_OTHER||Chi-Squared|2.43||||0.4884|TWO_SIDED||||||Chi-squared|Degrees of Freedom: 3||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The time interaction component of the model is reported below.||||0.4884
72509187|NCT00431847|144548630|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.6174|STANDARD_ERROR_OF_MEAN|1.3991||0.6593|TWO_SIDED|95.0|-2.1348|3.3696|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.||3.3696|-2.1348|0.6593
72623543|NCT03895372|144777805|SUPERIORITY||Risk Difference (RD)|27.78|||||TWO_SIDED|90.0|8.86|43.26||||||The analysis was based on the data at Week 16.||43.26|8.86|
72623544|NCT03895372|144777805|SUPERIORITY||Risk Difference (RD)|54.07|||||TWO_SIDED|90.0|36.46|68.27||||||The analysis was based on the data at Week 16.||68.27|36.46|
72400075|NCT03255382|144307971|OTHER||Least Squares Mean Difference|0.059|STANDARD_ERROR_OF_MEAN|0.0186||0.002|TWO_SIDED|95.0|0.022|0.096|||ANCOVA|||P-values were calculated using ANCOVA with strata (phototherapy \[yes/no\]), baseline value, and treatment in the model.||0.096|0.022|0.002
72400076|NCT03255382|144307972|OTHER||Least Squares Mean Difference|14.9|STANDARD_ERROR_OF_MEAN|2.8|<|0.001|TWO_SIDED|95.0|9.4|20.5|||ANCOVA|||P-values were calculated using ANCOVA with strata (phototherapy \[yes/no\]), baseline value, and treatment in the model.||20.5|9.4|< 0.001
72400077|NCT03255382|144307973|OTHER||Least Squares Mean Difference|16.8|STANDARD_ERROR_OF_MEAN|2.73|<|0.001|TWO_SIDED|95.0|11.4|22.2|||ANCOVA|||P-values were calculated using ANCOVA with strata (phototherapy \[yes/no\]), baseline value, and treatment in the model.||22.2|11.4|< 0.001
72400078|NCT03255382|144307974|OTHER||Least Squares Mean Difference|-11.4|STANDARD_ERROR_OF_MEAN|2.64|<|0.001|TWO_SIDED|95.0|-16.6|-6.2|||ANCOVA|||P-values were calculated using ANCOVA with strata (phototherapy \[yes/no\]), baseline value, and the treatment in this model.||-6.2|-16.6|< 0.001
72478836|NCT01052103|144483470|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|0.0|STANDARD_ERROR_OF_MEAN|0.2||0.851||95.0|||||Type 3 Sums of Squares|||Changes from baseline to all post-baseline visits were analyzed using a restricted maximum likelihood-based MMRM. Model terms included fixed class effects for visit, investigative site, treatment, SOC type, baseline positive symptom stratum, and treatment-by-visit interaction as well as the continuous, fixed covariates of baseline measurement and baseline-by-visit interaction.||||0.851
72478837|NCT01052103|144483474|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|0.0||||0.999|TWO_SIDED|95.0|-4.3|4.3||P-value is for standing systolic BP.|Type 3 Sums of Squares|||Changes from baseline to all post-baseline visits were analyzed using a restricted maximum likelihood-based MMRM. Model terms included fixed class effects for visit, investigative site, treatment, SOC type, baseline positive symptom stratum, and treatment-by-visit interaction as well as the continuous, fixed covariates of baseline measurement and baseline-by-visit interaction.||4.3|-4.3|0.999
72478838|NCT01052103|144483474|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|3.8||||0.009|TWO_SIDED|95.0|1.0|6.7||P-value is for standing diastolic BP.|Type 3 Sums of Squares|||Changes from baseline to all post-baseline visits were analyzed using a restricted maximum likelihood-based MMRM. Model terms included fixed class effects for visit, investigative site, treatment, SOC type, baseline positive symptom stratum, and treatment-by-visit interaction as well as the continuous, fixed covariates of baseline measurement and baseline-by-visit interaction.||6.7|1.0|0.009
72478839|NCT01052103|144483475|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|-0.5||||0.818|TWO_SIDED|95.0|-5.0|3.9|||Type 3 Sums of Squares|||Changes from baseline to all post-baseline visits were analyzed using a restricted maximum likelihood-based MMRM. Model terms included fixed class effects for visit, investigative site, treatment, SOC type, baseline positive symptom stratum, and treatment-by-visit interaction as well as the continuous, fixed covariates of baseline measurement and baseline-by-visit interaction.||3.9|-5.0|0.818
72478840|NCT01052103|144483476|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|-0.44||||0.571|TWO_SIDED|95.0|-1.98|1.1|||Type 3 Sums of Squares|||Changes from baseline to all post-baseline visits were analyzed using a restricted maximum likelihood-based MMRM. Model terms included fixed class effects for visit, investigative site, treatment, SOC type, baseline positive symptom stratum, and treatment-by-visit interaction as well as the continuous, fixed covariates of baseline measurement and baseline-by-visit interaction.||1.10|-1.98|0.571
72478841|NCT01052103|144483481|SUPERIORITY_OR_OTHER_LEGACY|||||||0.682||95.0||||P-value is for treatment-emergent suicidal ideation.|Fisher Exact|||||||0.682
72478842|NCT01052103|144483482|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|1.0|STANDARD_ERROR_OF_MEAN|1.7||0.727||95.0||||One-sided p-value.|Type 3 Sums of Squares|||Changes from baseline to all post-baseline visits were analyzed using a restricted maximum likelihood-based MMRM. Model terms included fixed class effects for visit, investigative site, treatment, SOC type, baseline positive symptom stratum, and treatment-by-visit interaction as well as the continuous, fixed covariates of baseline measurement and baseline-by-visit interaction.||||0.727
72478843|NCT01052103|144483486|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|-1.7|STANDARD_ERROR_OF_MEAN|3.4||0.305||95.0||||One-sided p-value.|Type 3 Sums of Squares|||Changes from baseline to all post-baseline visits were analyzed using a restricted maximum likelihood-based MMRM. Model terms included fixed class effects for visit, investigative site, treatment, SOC type, baseline positive symptom stratum, and treatment-by-visit interaction as well as the continuous, fixed covariates of baseline measurement and baseline-by-visit interaction.||||0.305
72478844|NCT01052103|144483487|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|-0.5|STANDARD_ERROR_OF_MEAN|2.5||0.42||95.0||||One-sided p-value.|Type 3 Sums of Squares|||Changes from baseline to all post-baseline visits were analyzed using a restricted maximum likelihood-based MMRM. Model terms included fixed class effects for visit, investigative site, treatment, SOC type, baseline positive symptom stratum, and treatment-by-visit interaction as well as the continuous, fixed covariates of baseline measurement and baseline-by-visit interaction.||||0.420
72478845|NCT05398237|144483518|OTHER|A self-contained, subject-level permutation test for changes of all analytes in a pathway, assuming all analyte levels increasing after SSL exposure.||||||0.0122||||||Change in pathway from baseline to 1 hour post-SSL. Threshold for p-value of each test is 0.05/4=0.0125 based on Bonferroni adjustment for four tests, with two time points and two pathways (TLR4 and TOPK/PRPK).|Permutation test|The self-contained, subject-level permutation test comparing the pre- and post-SSL levels of all analytes in the pathway.||This is a single-arm study||||0.0122
72478846|NCT05398237|144483518|OTHER|A self-contained, subject-level permutation test for changes of all analytes in a pathway, assuming all analyte levels increasing after SSL exposure.||||||0.009||||||Change in pathway from baseline to 24 hours post-SSL. Threshold for p-value of each test is 0.05/4=0.0125 based on Bonferroni adjustment for four tests, with two time points and two pathways (TLR4 and TOPK/PRPK)|Permutation test|The self-contained, subject-level permutation test comparing the pre- and post-SSL levels of all analytes in the pathway.||This is a single-arm study.||||0.009
72623545|NCT03895372|144777806|SUPERIORITY||Risk Difference (RD)|1.52|||||TWO_SIDED|90.0|-14.52|20.77||||||The analysis was based on the data at Week 16.||20.77|-14.52|
72400079|NCT03255382|144307975|OTHER||Least Squares Mean Difference|-13.7|STANDARD_ERROR_OF_MEAN|2.7|<|0.001|TWO_SIDED|95.0|-19.1|-8.4|||ANCOVA|||P-values were calculated using ANCOVA with strata (phototherapy \[yes/no\]), baseline value, and the treatment in this model.||-8.4|-19.1|< 0.001
72400080|NCT03255382|144307976|OTHER||Least Squares Mean Difference|-17.3|STANDARD_ERROR_OF_MEAN|3.75|<|0.001|TWO_SIDED|95.0|-24.8|-9.8|||ANCOVA|||P-values were calculated using ANCOVA with strata (phototherapy \[yes/no\]), baseline value, and the treatment in this model.||-9.8|-24.8|< 0.001
72400081|NCT03255382|144307977|OTHER||Least Squares Mean Difference|-21.5|STANDARD_ERROR_OF_MEAN|3.66|<|0.001|TWO_SIDED|95.0|-28.8|-14.2|||ANCOVA|||P-values were calculated using ANCOVA with strata (phototherapy \[yes/no\]), baseline value, and the treatment in this model.||-14.2|-28.8|< 0.001
72478847|NCT05398237|144483519|OTHER|A self-contained, subject-level permutation test for changes of all analytes in a pathway, assuming all analyte levels increasing after SSL exposure.||||||0.0063||||||Change in pathway from baseline to 1 hour post-SSL. Threshold for p-value of each test is 0.05/4=0.0125 based on Bonferroni adjustment for four tests, with two time points and two pathways (TLR4 and TOPK/PRPK)|Permutation test|The self-contained, subject-level permutation test comparing the pre- and post-SSL levels of all analytes in the pathway.||This is a single-arm study||||0.0063
72478848|NCT05398237|144483519|OTHER|A self-contained, subject-level permutation test for changes of all analytes in a pathway, assuming all analyte levels increasing after SSL exposure.||||||0.0056||||||Change in pathway from baseline to 24 hours post-SSL. Threshold for p-value of each test is 0.05/4=0.0125 based on Bonferroni adjustment for four tests, with two time points and two pathways (TLR4 and TOPK/PRPK)|Permutation test|The self-contained, subject-level permutation test comparing the pre- and post-SSL levels of all analytes in the pathway.||This is a single-arm study.||||0.0056
72478849|NCT01749904|144483523|NON_INFERIORITY|The 2 treatments were compared for each time point by visit. LS mean of each treatment group, the difference in the LS mean, and the 2-sided 95% CI for the difference were obtained. Noninferiority could be claimed if the upper limit of the CIs \<1.5 mmHg at all time points of each visit and \<1.00 mmHg for at least 5 out of the 9 time points. If noninferiority was determined, superiority at each time point could be claimed if the upper limit of the 95% CI\<0 mmHg at all time points of each visit.|||||<|0.01||||||The ANCOVA results for the comparison of LS means of mean IOP between treatment groups demonstrated noninferiority of BOL-303259-X to timolol and also superiority of BOL-303259-X to timolol|ANCOVA|||||||<0.01
72478850|NCT01749904|144483524|OTHER|||||||0.005|||||||Chi-squared|||||||0.005
72478851|NCT01749904|144483525|OTHER|||||||0.001|||||||Chi-squared|||||||0.001
72478852|NCT01749904|144483526|OTHER||||||||||||||||||No statistical analysis was performed on these proportions.|||
72478853|NCT02318992|144483562|OTHER|||||||0.157|||||||Chi-squared, Corrected|||||||0.157
72478854|NCT02318992|144483563|OTHER|||||||0.041|||||||Chi-squared, Corrected|||||||0.041
72478855|NCT00552240|144483564|NON_INFERIORITY_OR_EQUIVALENCE|A point estimate of -6.5% or higher for the diff. in the prop. of responders (NVP - ATV/r) was to be considered consistent with a successful ArTEN study. In the worst case for both studies, if the 2 studies were to be pooled, the non-inferiority margin of -12% would then be outside the 95% confidence interval (CI).|Difference in proportion of responders|-0.041||||0.7142||95.0|-0.183|0.101|||Cochran-Mantel-Haenszel|Controlling for screening viral load and CD4+ categories||With 75 evaluable patients per treatment group, this study had 80% power to observe a difference no lower than -6.5% assuming the true proportions of responders are both 65%.||0.101|-0.183|0.7142
72478856|NCT00552240|144483565|NON_INFERIORITY_OR_EQUIVALENCE|Same as for the primary analysis|Difference in proportion of responders|-0.027||||0.6479||95.0|-0.167|0.113|||Cochran-Mantel-Haenszel|Controlling for screening viral load and CD4+ categories||||0.113|-0.167|0.6479
72478857|NCT00552240|144483566|NON_INFERIORITY_OR_EQUIVALENCE|Same as for primary analysis|Difference in proportion of responders|0.084||||0.1477||95.0|-0.03|0.197|||Cochran-Mantel-Haenszel|Controlling for screening viral load and CD4+ categories||||0.197|-0.030|0.1477
72478858|NCT00552240|144483567|NON_INFERIORITY_OR_EQUIVALENCE|Same as for primary analysis|Difference in proportion of responders|-0.067||||0.3703||95.0|-0.215|0.08|||Cochran-Mantel-Haenszel|Controlling for screening viral load and CD4+ categories||||0.080|-0.215|0.3703
72478859|NCT00552240|144483568|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.666||||0.0314||95.0|0.46|0.964|||Regression, Cox|Controlling for screening viral load and CD4+ categories.||Hazard ratio Atazanavir plus ritonavir / Nevirapine. Values \< 1 indicate faster response in nevirapine.||0.964|0.460|0.0314
72478860|NCT00552240|144483569|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.628||||0.0172||95.0|0.428|0.921|||Regression, Cox|Controlling for screening viral load and CD4+ categories||"Responders only~Hazard ratio Atazanavir plus ritonavir / Nevirapine. Values \< 1 indicate faster response in nevirapine."||0.921|0.428|0.0172
72478861|NCT00552240|144483597|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|1.8||||0.7315||95.0|-8.4|11.9|||ANCOVA|Controlling for screening viral load and CD4+ categories||||11.9|-8.4|0.7315
72400082|NCT03706794|144307993|SUPERIORITY||Mann-Whitney U|43.0||||0.829|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.829
72400083|NCT03706794|144307994|SUPERIORITY||Mann-Whitney U|45.5||||0.633|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.633
72400084|NCT03706794|144307995|SUPERIORITY||Mann-Whitney U|45.5||||0.633|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.633
72400085|NCT03706794|144307996|SUPERIORITY||Mann-Whitney U|46.0||||0.633|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.633
72400086|NCT03706794|144307997|SUPERIORITY||Mann-Whitney U|52.0||||0.315|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.315
72478862|NCT00552240|144483598|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-10.6||||0.3625||95.0|-33.4|12.3|||ANCOVA|Controlling for screening viral load and CD4+ categories||||12.3|-33.4|0.3625
72478863|NCT00552240|144483599|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.8||||0.0164||95.0|0.9|8.8|||ANCOVA|Controlling for screening viral load and CD4+ categories||||8.8|0.9|0.0164
72478864|NCT00552240|144483600|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.4||||0.9257||95.0|-8.4|9.3|||ANCOVA|Controlling for screening viral load and CD4+ categories||||9.3|-8.4|0.9257
72478865|NCT00552240|144483601|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.33||||0.0375||95.0|-0.64|-0.02|||ANCOVA|Controlling for screening viral load and CD4+ categories||||-0.02|-0.64|0.0375
72478866|NCT00552240|144483602|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.28||||0.4645||95.0|-1.02|0.47|||ANCOVA|Controlling for screening viral load and CD4+ categories||||0.47|-1.02|0.4645
72566512|NCT02697773|144663298|SUPERIORITY||LS Mean Ratio|0.85|STANDARD_ERROR_OF_MEAN|0.33||0.6821|TWO_SIDED|95.0|0.4|1.82|||Negative binomial model|||Week 12: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.||1.82|0.40|0.6821
72623546|NCT03895372|144777806|SUPERIORITY||Risk Difference (RD)|-2.38|||||TWO_SIDED|90.0|-17.67|17.01||||||The analysis was based on the data at Week 16.||17.01|-17.67|
72623547|NCT03895372|144777806|SUPERIORITY||Risk Difference (RD)|27.78|||||TWO_SIDED|90.0|8.86|43.26||||||The analysis was based on the data at Week 16.||43.26|8.86|
72623548|NCT03895372|144777806|SUPERIORITY||Risk Difference (RD)|54.07|||||TWO_SIDED|90.0|36.46|68.27||||||The analysis was based on the data at Week 16.||68.27|36.46|
72400087|NCT03011307|144308032|SUPERIORITY|A likelihood-ratio test for change in pain was conducted for each outcome comparing a model with and without oxytocin treatment group. A statistically significant result is interpreted as evidence to support that the oxytocin treatment impacts some element of change after surgery (i.e, intercept or slope).|Intercept Difference in score on a scale|0.1||||0.75|TWO_SIDED|95.0|0.0|0.2||P value not adjusted for multiple comparisons, with threshold of statistical significance set at \<0.05|Mixed Models Analysis|||The estimates were conducted using a linear mixed effects model contrasting differences in the oxytocin group versus placebo. In all cases, these differences are adjusted for prognostic variables including baseline pain, baseline opioid use, age, sex, baseline PROMIS depression and number of other painful conditions.||.2|0|0.75
72478867|NCT02783768|144483616|OTHER|Testing for difference in the outcome measure according to the exposure (which was not a treatment) in a randomized crossover setting.|Mean Difference (Net)|13.98||||0.012|TWO_SIDED|95.0|4.012|23.94|||Mixed Models Analysis||Measurements were included for participants with at least one valid MRI measurement.|"Within-person effects of e-cigarette exposure on pulmonary microvascular blood flow (PMBF) was assessed via mixed models accounting for order effects.~Null hypothesis: e-cigarette exposure is NOT associated with a change in PMBF.~Alternative hypothesis: e-cigarette exposure IS associated with a change in PMBF.~Power calculation: not applicable since this was a pilot/feasibility study."||23.94|4.012|0.012
72623549|NCT03895372|144777809|SUPERIORITY||Least Squares Mean Difference|-1.46|||||TWO_SIDED|90.0|-5.42|2.51||||||The analysis was based on the data at Week 16.||2.51|-5.42|
72623550|NCT03895372|144777809|SUPERIORITY||Least Squares Mean Difference|-3.54|||||TWO_SIDED|90.0|-7.5|0.42||||||The analysis was based on the data at Week 16.||0.42|-7.50|
72623551|NCT03895372|144777809|SUPERIORITY||Least Squares Mean Difference|-9.8|||||TWO_SIDED|90.0|-13.05|-6.56||||||The analysis was based on the data at Week 16.||-6.56|-13.05|
72478868|NCT02319525|144483658|SUPERIORITY_OR_OTHER|||||||0.005|||||||t-test, 2 sided|||||||0.005
72478869|NCT02319525|144483659|SUPERIORITY_OR_OTHER|||||||0.08||||||We compared informed choice vs. no informed choice made between the decision aid and the pamphlet groups.|Chi-squared|||||||0.08
72478870|NCT02319525|144483660|SUPERIORITY_OR_OTHER|||||||0.252|||||||Chi-squared|||We compared concordance between preferred and actual roles vs. no concordance between roles between decision aid and pamphlet.||||0.252
72478871|NCT02319525|144483661|SUPERIORITY_OR_OTHER|||||||0.504|||||||t-test, 2 sided|||||||0.504
72478872|NCT02319525|144483662|SUPERIORITY_OR_OTHER|||||||0.06|||||||t-test, 2 sided|||||||0.06
72478873|NCT02319525|144483663|SUPERIORITY_OR_OTHER|||||||0.006|||||||Chi-squared|||"statistical analysis comparing the decision-aid vs. pamphlet for patient rating of acceptability of information and presentation related to the Impact of lupus nephritis"||||0.006
72566513|NCT02697773|144663298|SUPERIORITY||LS Mean Ratio|0.77|STANDARD_ERROR_OF_MEAN|0.3||0.5032|TWO_SIDED|95.0|0.36|1.65|||Negative binomial model|||Week 12: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.||1.65|0.36|0.5032
72566514|NCT02697773|144663298|SUPERIORITY||LS Mean Ratio|1.24|STANDARD_ERROR_OF_MEAN|0.47||0.5796|TWO_SIDED|95.0|0.58|2.61|||Negative binomial model|||Week 16: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.||2.61|0.58|0.5796
72566515|NCT02697773|144663298|SUPERIORITY||LS Mean Ratio|0.94|STANDARD_ERROR_OF_MEAN|0.36||0.8725|TWO_SIDED|95.0|0.44|2.0|||Negative binomial model|||Week 16: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.||2.00|0.44|0.8725
72623552|NCT03895372|144777809|SUPERIORITY||Least Squares Mean Difference|-12.33|||||TWO_SIDED|90.0|-15.61|-9.04||||||The analysis was based on the data at Week 16.||-9.04|-15.61|
72623553|NCT03895372|144777810|SUPERIORITY||Least Squares Mean Difference|-8.63|||||TWO_SIDED|90.0|-23.61|6.35||||||The analysis was based on the data at Week 16.||6.35|-23.61|
72623554|NCT03895372|144777810|SUPERIORITY||Least Squares Mean Difference|-13.02|||||TWO_SIDED|90.0|-27.98|1.94||||||The analysis was based on the data at Week 16.||1.94|-27.98|
72478874|NCT02319525|144483663|SUPERIORITY_OR_OTHER|||||||0.006|||||||Chi-squared|||"statistical analysis comparing the decision-aid vs. pamphlet for patient rating of acceptability of information and presentation related to the Risk factors"||||0.006
72478875|NCT02319525|144483663|SUPERIORITY_OR_OTHER|||||||0.003|||||||Chi-squared|||"statistical analysis comparing the decision-aid vs. pamphlet for patient rating of acceptability of information and presentation related to the medication options"||||0.003
72478876|NCT02319525|144483663|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Chi-squared|||"statistical analysis comparing the decision-aid vs. pamphlet for patient rating of acceptability of information and presentation related to the evidence about medications"||||<0.001
72478877|NCT02319525|144483663|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Chi-squared|||"statistical analysis comparing the decision-aid vs. pamphlet for patient rating of acceptability of information and presentation related to the study about other patients"||||<0.001
72623555|NCT03895372|144777810|SUPERIORITY||Least Squares Mean Difference|-40.74|||||TWO_SIDED|90.0|-53.02|-28.46||||||The analysis was based on the data at Week 16.||-28.46|-53.02|
72623556|NCT03895372|144777810|SUPERIORITY||Least Squares Mean Difference|-53.04|||||TWO_SIDED|90.0|-65.44|-40.63||||||The analysis was based on the data at Week 16.||-40.63|-65.44|
72623557|NCT03895372|144777811|SUPERIORITY||Least Squares Mean Difference|-1.22|||||TWO_SIDED|90.0|-2.52|0.09||||||The analysis was based on the data at Week 16.||0.09|-2.52|
72623558|NCT03895372|144777811|SUPERIORITY||Least Squares Mean Difference|-1.21|||||TWO_SIDED|90.0|-2.46|0.05||||||The analysis was based on the data at Week 16.||0.05|-2.46|
72623559|NCT03895372|144777811|SUPERIORITY||Least Squares Mean Difference|-3.47|||||TWO_SIDED|90.0|-4.51|-2.43||||||The analysis was based on the data at Week 16.||-2.43|-4.51|
72478878|NCT02319525|144483664|SUPERIORITY_OR_OTHER|||||||0.006|||||||Chi-squared|||The test of significance compared all the rows, i.e., all response options for the statement.||||0.006
72478879|NCT05249829|144483713|NON_INFERIORITY|Non-inferiority was demonstrated if the lower bound of the 99% CI of the Geometric Mean Ratio was \>0.667.|Geometric Mean Ratio|1.73|||||TWO_SIDED|99.0|1.493|2.005||||||Geometric Mean Ratio = GMCmRNA-1273.529/GMCmRNA-1273 against the B.1.1.529 strain at Day 29 after study vaccine administration.||2.005|1.493|
72509188|NCT00431847|144548630|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.4575|STANDARD_ERROR_OF_MEAN|2.0263||0.0889|TWO_SIDED|95.0|-0.528|7.4431|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.||7.4431|-0.5280|0.0889
72509189|NCT00431847|144548630|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.4499|STANDARD_ERROR_OF_MEAN|2.8061||0.8727|TWO_SIDED|95.0|-5.9692|5.0694|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.||5.0694|-5.9692|0.8727
72509190|NCT00431847|144548631|SUPERIORITY_OR_OTHER||Slope|-0.523|STANDARD_ERROR_OF_MEAN|0.08855|<|0.0001|TWO_SIDED|95.0|-0.6973|-0.3486|||Mixed Models Analysis|||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group. The overall slope of the model (below) is reported as a continuous variable for time since injury.||-0.3486|-0.6973|<.0001
72566516|NCT00842530|144663316|SUPERIORITY|The vaccine efficacy of the CYD dengue vaccine against severe VCD cases was considered significant only if the lower bound of its 95% CI was greater than 0%.|Vaccine efficacy (%)|30.2|||||TWO_SIDED|95.0|-13.4|56.6||||||Vaccine efficacy of CYD dengue vaccine: The statistical methodology was based on the use of the two-sided 95% confidence interval (CI) of the vaccine efficacy. The CI was calculated using the exact method conditional on the total number of cases in both groups.||56.6|-13.4|
72566517|NCT00842530|144663317|OTHER|The statistical methodology was based on the use of the two-sided 95% CI of the vaccine efficacy. The CI was calculated using the exact method conditional on the total number of cases in both groups. The vaccine efficacy of the CYD dengue vaccine against severe VCD cases was considered significant if the lower bound of its 95% CI was greater than 0%.|Vaccine efficacy (%)|75.2|||||TWO_SIDED|95.0|-377.0|99.6||||||Vaccine efficacy against severe VCD (IDMC)||99.6|-377|
72566518|NCT00842530|144663317|OTHER|The statistical methodology was based on the use of the two-sided 95% CI of the vaccine efficacy. The CI was calculated using the exact method conditional on the total number of cases in both groups. The vaccine efficacy of the CYD dengue vaccine against severe VCD cases was considered significant if the lower bound of its 95% CI was greater than 0%.|Vaccine efficacy (%)|50.3|||||TWO_SIDED|95.0|-585.0|96.4||||||Vaccine efficacy of against severe VCD (WHO 1999)||96.4|-585|
72566519|NCT00842530|144663318|SUPERIORITY|The statistical methodology was based on the use of the two-sided 95% CI of the vaccine efficacy. The CI was calculated using the exact method conditional on the total number of cases in both groups. The vaccine efficacy of the CYD dengue vaccine against severe VCD cases was considered significant only if the lower bound of its 95% CI was greater than 0%.|Vaccine efficacy (%)|41.5|||||TWO_SIDED|95.0|-38.4|74.9||||||Vaccine efficacy:- 28 days Post-Inj. 2 up to Inj. 3||74.9|-38.4|
72623560|NCT03895372|144777811|SUPERIORITY||Least Squares Mean Difference|-3.66|||||TWO_SIDED|90.0|-4.71|-2.61||||||The analysis was based on the data at Week 16.||-2.61|-4.71|
72623561|NCT03895372|144777812|SUPERIORITY||Risk Difference (RD)|12.99|||||TWO_SIDED|90.0|-4.52|32.87||||||The analysis was based on the data at Week 16.||32.87|-4.52|
72478880|NCT05249829|144483714|NON_INFERIORITY|Non-inferiority was demonstrated if the lower bound of the 96% CI of the Geometric Mean Ratio was \>0.667.|Geometric Mean Ratio|1.763|||||TWO_SIDED|96.0|1.546|2.01||||||Geometric Mean Ratio = GMCmRNA-1273.529/GMCmRNA-1273 against the B.1.1.529 strain at Day 85 after study vaccine administration.||2.010|1.546|
72478881|NCT05249829|144483715|OTHER|Non-inferiority was demonstrated if the lower bound of the 99% CI of the Geometric Mean Ratio was \>0.667. Superiority was demonstrated if the lower bound of the 99% CI of the Geometric Mean Ratio was \>1.|Geometric Mean Ratio|1.535|||||TWO_SIDED|99.0|1.409|1.672||||||Geometric Mean Ratio = GMCmRNA-1273.214/GMCmRNA-1273 against the B.1.1.529 strain at Day 29 after study vaccine administration.||1.672|1.409|
72509191|NCT00431847|144548631|SUPERIORITY_OR_OTHER||Chi-Squared|4.89||||0.18|TWO_SIDED||||||Chi-squared|Degrees of Freedom: 3||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The time interaction component of the model is reported below.||||0.1800
72509192|NCT00431847|144548631|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.302|STANDARD_ERROR_OF_MEAN|2.8198||0.4151|TWO_SIDED|95.0|-3.253|7.857|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.||7.8570|-3.2530|0.4151
72509193|NCT00431847|144548631|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.3376|STANDARD_ERROR_OF_MEAN|4.314||0.3157|TWO_SIDED|95.0|-4.1592|12.8344|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.||12.8344|-4.1592|0.3157
72623562|NCT03895372|144777812|SUPERIORITY||Risk Difference (RD)|23.81|||||TWO_SIDED|90.0|2.62|44.64||||||The analysis was based on the data at Week 16.||44.64|2.62|
72623563|NCT03895372|144777812|SUPERIORITY||Risk Difference (RD)|41.27|||||TWO_SIDED|90.0|23.47|56.18||||||The analysis was based on the data at Week 16.||56.18|23.47|
72509194|NCT00431847|144548631|SUPERIORITY_OR_OTHER||Mean Difference (Net)|11.825|STANDARD_ERROR_OF_MEAN|6.9715||0.0911|TWO_SIDED|95.0|-1.904|25.5541|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.||25.5541|-1.9040|0.0911
72509195|NCT00431847|144548632|SUPERIORITY_OR_OTHER||Slope|-0.2888|STANDARD_ERROR_OF_MEAN|0.09078||0.0016|TWO_SIDED|95.0|-0.4675|-0.11|||Mixed Models Analysis|||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group. The overall slope of the model (below) is reported as a continuous variable for time since injury.||-0.1100|-0.4675|0.0016
72478882|NCT05249829|144483716|OTHER|Non-inferiority was demonstrated if the lower bound of the 99% CI of the Geometric Mean Ratio was \>0.667. Superiority was demonstrated if the lower bound of the 99% CI of the Geometric Mean Ratio was \>1.|Geometric Mean Ratio|1.713|||||TWO_SIDED|96.0|1.583|1.853||||||Geometric Mean Ratio = GMCmRNA-1273.214/GMCmRNA-1273 against the B.1.1.529 strain at Day 85 after study vaccine administration.||1.853|1.583|
72478883|NCT05249829|144483717|NON_INFERIORITY|Non-inferiority was demonstrated if the lower bound of the 99% CI of the Geometric Mean Ratio was \>0.667.|Geometric Mean Ratio|1.048|||||TWO_SIDED|99.0|0.958|1.147||||||Geometric Mean Ratio = GMCmRNA-1273.214/GMCmRNA-1273 against the ancestral strain at Day 29 after study vaccine administration. Reported statistical analysis based upon the number of participants with non-missing data at baseline and the corresponding timepoint (N=1818).||1.147|0.958|
72478884|NCT05249829|144483718|OTHER|Non-inferiority was demonstrated if the lower bound of the 99% CI of the Geometric Mean Ratio was \>0.667.|Geometric Mean Ratio|1.104|||||TWO_SIDED|96.0|1.032|1.18||||||Geometric Mean Ratio = GMCmRNA-1273.214/GMCmRNA-1273 against the ancestral strain at Day 85 after study vaccine administration. Reported statistical analysis based upon the number of participants with non-missing data at baseline and the corresponding timepoint (N=1418).||1.180|1.032|
72478885|NCT05249829|144483725|SUPERIORITY|Superiority was demonstrated if the lower bound of the 99% CI of the Geometric Mean Ratio was \>1.|Geometric Mean Ratio|1.73|||||TWO_SIDED|99.0|1.493|2.005||||||Geometric Mean Ratio = GMCmRNA-1273.529/GMCmRNA-1273 against the B.1.1.529 strain at Day 29 after study vaccine administration.||2.005|1.493|
72478886|NCT05249829|144483725|SUPERIORITY|Superiority was demonstrated if the lower bound of the 96% CI of the Geometric Mean Ratio was \>1.|Geometric Mean Ratio|1.763|||||TWO_SIDED|96.0|1.546|2.01||||||Geometric Mean Ratio = GMCmRNA-1273.529/GMCmRNA-1273 against the B.1.1.529 strain at Day 85 after study vaccine administration. Reported statistical analysis based upon the number of participants with non-missing data at baseline and the corresponding timepoint (N=460).||2.010|1.546|
72478887|NCT02842827|144483776|OTHER|||||||0.3868|||||||Kruskal-Wallis|p-value of the treatment effect was calculated between all dose arms with ≥3 participants||||||0.3868
72478888|NCT02842827|144483777|OTHER|||||||0.7744|||||||Kruskal-Wallis|p-value of the treatment effect was calculated between all dose arms with ≥3 participants||||||0.7744
72509196|NCT00431847|144548632|SUPERIORITY_OR_OTHER||Chi-Squared|6.33||||0.0966|TWO_SIDED||||||Chi-squared|Degrees of Freedom: 3||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The time interaction component of the model is reported below.||||0.0966
72478889|NCT02842827|144483778|OTHER|||||||0.508|||||||Kruskal-Wallis|p-value of the treatment effect was calculated between all dose arms with ≥3 participants||||||0.5080
72478890|NCT02842827|144483779|OTHER|||||||0.6109|||||||Kruskal-Wallis|p-value of the treatment effect was calculated between all dose arms with ≥3 participants||||||0.6109
72478891|NCT02842827|144483780|OTHER|||||||0.1151|||||||Kruskal-Wallis|p-value of the treatment effect was calculated between all dose arms with ≥3 participants||||||0.1151
72478892|NCT02842827|144483781|OTHER|||||||0.0791|||||||Kruskal-Wallis|p-value of the treatment effect was calculated between all dose arms with ≥3 participants||||||0.0791
72478893|NCT03386110|144483782|SUPERIORITY||Risk Ratio, log|1.19||||0.08|TWO_SIDED|95.0|-0.15|2.54|||Mixed Models Analysis|Model testing whether condition predicted illicit drug use at 3-months||Multi-level models tested whether treatment condition predicted outcome at 3-month follow-up, and controlled for the nesting of participants within couples.||2.54|-0.15|0.08
72478894|NCT03386110|144483782|SUPERIORITY||Risk Ratio, log|0.7||||0.25|TWO_SIDED|95.0|-0.49|1.89|||Mixed Models Analysis|Model testing whether condition predicted illicit drug use at 6-months||Multi-level models tested whether treatment condition predicted outcome at 6-months, and controlled for the nesting of participants within couples.||1.89|-0.49|0.25
72509197|NCT00431847|144548632|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.9879|STANDARD_ERROR_OF_MEAN|2.4264||0.2195|TWO_SIDED|95.0|-1.7938|7.7697|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.||7.7697|-1.7938|0.2195
72509198|NCT00431847|144548632|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.4636|STANDARD_ERROR_OF_MEAN|3.7381||0.5105|TWO_SIDED|95.0|-9.8289|4.9018|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.||4.9018|-9.8289|0.5105
72509199|NCT00431847|144548632|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-10.3871|STANDARD_ERROR_OF_MEAN|6.1087||0.0903|TWO_SIDED|95.0|-22.4174|1.6433|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.||1.6433|-22.4174|0.0903
72566520|NCT00842530|144663318|SUPERIORITY|The statistical methodology was based on the use of the two-sided 95% CI of the vaccine efficacy. The CI was calculated using the exact method conditional on the total number of cases in both groups. The vaccine efficacy of the CYD dengue vaccine against severe VCD cases was considered significant only if the lower bound of its 95% CI was greater than 0%.|Vaccine efficacy (%)|35.3|||||TWO_SIDED|95.0|3.3|56.5||||||Vaccine efficacy: 28 days Post-Inj. 2 up to end of Active Phase||56.5|3.3|
72566521|NCT00842530|144663324|OTHER|The statistical methodology was based on the use of the two-sided 95% CI of the vaccine efficacy. The CI was calculated using the exact method conditional on the total number of cases in both groups. The vaccine efficacy of the CYD dengue vaccine against severe VCD cases was considered significant if the lower bound of its 95% CI was greater than 0%.|Vaccine efficacy (%)|33.4|||||TWO_SIDED|95.0|4.1|53.5||||||Vaccine efficacy: 28 days Post-Inj. 1 up to end of Active Phase||53.5|4.1|
72566522|NCT00842530|144663324|OTHER|The statistical methodology was based on the use of the two-sided 95% CI of the vaccine efficacy. The CI was calculated using the exact method conditional on the total number of cases in both groups. The vaccine efficacy of the CYD dengue vaccine against severe VCD cases was considered significant if the lower bound of its 95% CI was greater than 0%.|Vaccine efficacy (%)|34.9|||||TWO_SIDED|95.0|6.7|54.3||||||Vaccine efficacy: Day 0 up to end of Active Phase||54.3|6.7|
72566523|NCT00486018|144663333|SUPERIORITY_OR_OTHER||Difference in Least Squares means|9.4|||<|0.0001||95.0|6.6|12.2||The Hochberg-Bonferroni multiple comparison procedure was used to adjust for comparisons of the two ranibizumab groups with the sham-injection group to maintain an overall type I error rate of 0.05.|ANOVA|Stratified by baseline visual acuity score (≤ 34, 35-54, ≥ 55 letters).||||12.2|6.6|<0.0001
72566524|NCT00486018|144663333|SUPERIORITY_OR_OTHER||Difference in Least Squares means|10.6|||<|0.0001||95.0|7.6|13.6||The Hochberg-Bonferroni multiple comparison procedure was used to adjust for comparisons of the two ranibizumab groups with the sham-injection group to maintain an overall type I error rate of 0.05.|ANOVA|Stratified by baseline visual acuity score (≤ 34, 35-54, ≥ 55 letters).||||13.6|7.6|<0.0001
72566525|NCT00486018|144663334|SUPERIORITY_OR_OTHER||Difference in percentage|26.8|||<|0.0001||95.0|15.6|38.0|||Cochran-Mantel-Haenszel χ²|Stratified by baseline visual acuity score (≤ 34, 35-54, ≥ 55 letters).|Weighted estimates adjusted for baseline visual acuity score (≤ 34, 35-54, ≥ 55 letters) using Cochran-Mantel-Haenszel weights.|||38.0|15.6|<0.0001
72566526|NCT00486018|144663334|SUPERIORITY_OR_OTHER||Difference in percentage|31.3|||<|0.0001||95.0|20.1|42.6|||Cochran-Mantel-Haenszel χ²|Stratified by baseline visual acuity score (≤ 34, 35-54, ≥ 55 letters).|Weighted estimates adjusted for baseline visual acuity score (≤ 34, 35-54, ≥ 55 letters) using Cochran-Mantel-Haenszel weights.|||42.6|20.1|<0.0001
72566527|NCT00486018|144663335|SUPERIORITY_OR_OTHER||Difference in percentage|4.5||||0.0141||95.0|1.6|9.9|||Fisher Exact||Exact confidence interval based on inverting the exact two-sided score test.|||9.9|1.6|0.0141
72623564|NCT03895372|144777812|SUPERIORITY||Risk Difference (RD)|49.13|||||TWO_SIDED|90.0|30.62|63.69||||||The analysis was based on the data at Week 16.||63.69|30.62|
72478895|NCT03386110|144483782|SUPERIORITY||Risk Ratio, log|1.79||||0.007|TWO_SIDED|95.0|0.49|3.09|||Mixed Models Analysis|Three-way interaction model testing whether baseline use (actor and partner) moderated the effect of condition on illicit drug use at 3-months||"Moderation analysis in 3-month follow-up data.~The hypothesis that baseline frequency may moderate the effects of treatment at 3-months was evaluated using models incorporating participants' baseline report of the outcome (actor) as well as their partners' report (partner) at Level 1. Interactions among actor and partner baseline scores and treatment condition were also included at Level 1. Additionally, the model controlled for the nesting of participants within couples."||3.09|0.49|0.007
72478896|NCT03386110|144483782|SUPERIORITY||Risk Ratio, log|-0.36||||0.71|TWO_SIDED|95.0|-2.26|1.53|||Mixed Models Analysis|Three-way interaction model testing whether baseline use (actor and partner) moderated the effect of condition on illicit drug use at 6-months||"Moderation analysis in 6-month follow-up data.~The hypothesis that baseline frequency may moderate the effects of treatment at 6-months was evaluated using models incorporating participants' baseline report of the outcome (actor) as well as their partners' report (partner) at Level 1. Interactions among actor and partner baseline scores and treatment condition were also included at Level 1. Additionally, the model controlled for the nesting of participants within couples."||1.53|-2.26|0.71
72566528|NCT00486018|144663335|SUPERIORITY_OR_OTHER||Difference in percentage|3.0||||0.2815||95.0|-1.5|8.3|||Fisher Exact||Exact confidence interval based on inverting the exact two-sided score test.|||8.3|-1.5|0.2815
72566529|NCT00486018|144663336|SUPERIORITY_OR_OTHER||Difference in percentage|45.5|||<|0.0001||95.0|36.0|55.0|||Cochran-Mantel-Haenszel χ²|Stratified by baseline visual acuity score (≤ 34, 35-54, ≥ 55 letters).|Weighted estimates adjusted for baseline visual acuity score (≤ 34, 35-54, ≥ 55 letters) using Cochran-Mantel-Haenszel weights.|||55.0|36.0|<0.0001
72566530|NCT00486018|144663336|SUPERIORITY_OR_OTHER||Difference in percentage|40.1|||<|0.0001||95.0|29.9|50.2|||Cochran-Mantel-Haenszel χ²|Stratified by baseline visual acuity score (≤ 34, 35-54, ≥ 55 letters).|Weighted estimates adjusted for baseline visual acuity score (≤ 34, 35-54, ≥ 55 letters) using Cochran-Mantel-Haenszel weights.|||50.2|29.9|<0.0001
72566531|NCT00486018|144663337|SUPERIORITY_OR_OTHER||Difference in Least Squares means|-148.7|||<|0.0001||95.0|-183.6|-113.8|||ANCOVA|Pairwise ANCOVA models adjusted for baseline visual acuity score (≤ 34, 35-54, ≥ 55 letters) and baseline value of central foveal thickness.||||-113.8|-183.6|<0.0001
72566532|NCT00486018|144663337|SUPERIORITY_OR_OTHER||Difference in Least Squares means|-134.8|||<|0.0001||95.0|-172.7|-96.8|||ANCOVA|Pairwise ANCOVA models adjusted for baseline visual acuity score (≤ 34, 35-54, ≥ 55 letters) and baseline value of central foveal thickness.||||-96.8|-172.7|<0.0001
72566533|NCT00486018|144663338|SUPERIORITY_OR_OTHER||Difference in Least Squares means|4.1||||0.0214||95.0|0.6|7.6|||ANCOVA|Pairwise ANCOVA models adjusted for baseline visual acuity score (≤ 34, 35-54, ≥ 55 letters) and baseline Near Activities Subscale score.||||7.6|0.6|0.0214
72566534|NCT00486018|144663338|SUPERIORITY_OR_OTHER||Difference in Least Squares means|6.4||||0.0002||95.0|3.0|9.8|||ANCOVA|Pairwise ANCOVA models adjusted for baseline visual acuity score (≤ 34, 35-54, ≥ 55 letters) and baseline Near Activities Subscale score.||||9.8|3.0|0.0002
72623565|NCT03895372|144777813|SUPERIORITY||Least Squares Mean Difference|-4.21|||||TWO_SIDED|90.0|-7.82|-0.59||||||The analysis was based on the data at Week 16.||-0.59|-7.82|
72400088|NCT03011307|144308033|SUPERIORITY|A likelihood-ratio test for change in pain was conducted for each outcome comparing a model with and without oxytocin treatment group. A statistically significant result is interpreted as evidence to support that the oxytocin treatment impacts some element of change after surgery (i.e, intercept or slope).|Slope Difference|0.1||||0.057|TWO_SIDED|95.0|0.0|0.2||P value not adjusted for multiple comparisons, with threshold of statistical significance set at \<0.05|Mixed Models Analysis|||The estimates were conducted using a linear mixed effects model contrasting differences in the oxytocin group versus placebo. In all cases, these differences are adjusted for prognostic variables including baseline pain, baseline opioid use, age, sex, baseline PROMIS depression and number of other painful conditions.||0.2|0.0|0.057
72478897|NCT03386110|144483783|SUPERIORITY||Risk Ratio, log|0.36||||0.36|TWO_SIDED|95.0|-0.65|1.37|||Mixed Models Analysis|Model testing whether condition predicted CAS events at 3-months||Multi-level models tested whether treatment condition predicted outcome at 3-months, and controlled for the nesting of participants within couples.||1.37|-0.65|0.36
72478898|NCT03386110|144483783|SUPERIORITY||Risk Ratio, log|-0.18||||0.63|TWO_SIDED|95.0|-1.15|0.78|||Mixed Models Analysis|Model testing whether condition predicted CAS events at 6-months||Multi-level models tested whether treatment condition predicted outcome at 6-months, and controlled for the nesting of participants within couples.||0.78|-1.15|0.63
72478899|NCT03386110|144483783|SUPERIORITY||Risk Ratio, log|-0.54||||0.42|TWO_SIDED|95.0|-1.85|0.77|||Mixed Models Analysis|Three-way interaction model testing whether baseline rates of CAS (actor and partner) moderated the effect of condition on CAS events at 3-months||"Moderation analysis in 3-month follow-up data.~The hypothesis that baseline frequency may moderate the effects of treatment at 3-months was evaluated using models incorporating participants' baseline report of the outcome (actor) as well as their partners' report (partner) at Level 1. Interactions among actor and partner baseline scores and treatment condition were also included at Level 1. Additionally, the model controlled for the nesting of participants within couples."||0.77|-1.85|0.42
72478900|NCT03386110|144483783|SUPERIORITY||Risk Ratio, log|-1.7||||0.02|TWO_SIDED|95.0|-3.14|-0.27|||Mixed Models Analysis|Three-way interaction model testing whether baseline rates of CAS (actor and partner) moderated the effect of condition on CAS events at 6-months||"Moderation analysis in 6-month follow-up data.~The hypothesis that baseline frequency may moderate the effects of treatment at 6-months was evaluated using models incorporating participants' baseline report of the outcome (actor) as well as their partners' report (partner) at Level 1. Interactions among actor and partner baseline scores and treatment condition were also included at Level 1. Additionally, the model controlled for the nesting of participants within couples."||-0.27|-3.14|0.02
72478901|NCT03386110|144483784|SUPERIORITY||Risk Ratio, log|0.48||||0.15|TWO_SIDED|95.0|-0.18|1.44|||Mixed Models Analysis|Model testing whether condition predicted marijuana use at 3-months||Multi-level models tested whether treatment condition predicted outcome at 3-months, and controlled for the nesting of participants within couples.||1.44|-0.18|0.15
72478902|NCT03386110|144483784|SUPERIORITY||Risk Ratio, log|0.24||||0.5|TWO_SIDED|95.0|-0.44|0.92|||Mixed Models Analysis|Model testing whether condition predicted marijuana use at 6-months||Multi-level models tested whether treatment condition predicted outcome at 6-months, and controlled for the nesting of participants within couples.||0.92|-0.44|0.50
72478903|NCT03386110|144483784|SUPERIORITY||Risk Ratio, log|-0.02||||0.91|TWO_SIDED|95.0|-0.34|0.31|||Mixed Models Analysis|Three-way interaction model testing whether baseline use moderated the effect of condition on marijuana use at 3-months||"Moderation analysis in 3-month follow-up data.~The hypothesis that baseline frequency may moderate the effects of treatment was evaluated using models incorporating participants' baseline report of the outcome (actor) as well as their partners' report (partner) at Level 1. Interactions among actor and partner baseline scores and treatment condition were also included at Level 1. Additionally, the model controlled for the nesting of participants within couples."||0.31|-0.34|0.910
72509200|NCT00431847|144548633|SUPERIORITY_OR_OTHER||Slope|-0.04113|STANDARD_ERROR_OF_MEAN|-0.04113||0.6602|TWO_SIDED|95.0|-0.2252|0.1429|||Mixed Models Analysis|||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group. The overall slope of the model (below) is reported as a continuous variable for time since injury.||0.1429|-0.2252|0.6602
72478904|NCT03386110|144483784|SUPERIORITY||Risk Ratio, log|0.34||||0.11|TWO_SIDED|95.0|-0.07|0.75|||Mixed Models Analysis|||"Moderation analysis in 6-month follow-up data.~The hypothesis that baseline frequency may moderate the effects of treatment was evaluated using models incorporating participants' baseline report of the outcome (actor) as well as their partners' report (partner) at Level 1. Interactions among actor and partner baseline scores and treatment condition were also included at Level 1. Additionally, the model controlled for the nesting of participants within couples."||0.75|-0.07|0.11
72478905|NCT00943111|144483785|NON_INFERIORITY_OR_EQUIVALENCE|The sample size for study was based on expected stability rates of 95% for the Imiglucerase group and 85% for the Eliglustat group, power of 85%, a one-sided significance level of 0.025, a non-inferiority margin of 25%, and a 20% non-evaluable/drop-out rate. Eliglustat was declared non-inferior to Imiglucerase if the lower-bound of the 95% confidence interval for the difference was within the non-inferiority margin of 25%.|Difference in Percentage Stable|-8.8|||||TWO_SIDED|95.0|-17.6|4.2||||||||4.2|-17.6|
72478906|NCT04227704|144483854|SUPERIORITY|||||||0.09|||||||ANOVA|||||||0.09
72509201|NCT00431847|144548633|SUPERIORITY_OR_OTHER||Chi-Squared|1.53||||0.6764|TWO_SIDED||||||Chi-squared|Degrees of Freedom: 3||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The time interaction component of the model is reported below.||||0.6764
72509202|NCT00431847|144548633|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.4902|STANDARD_ERROR_OF_MEAN|2.6357||0.3458|TWO_SIDED|95.0|-2.7036|7.684|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.||7.6840|-2.7036|0.3458
72623566|NCT03895372|144777813|SUPERIORITY||Least Squares Mean Difference|-6.44|||||TWO_SIDED|90.0|-9.89|-2.99||||||The analysis was based on the data at Week 16.||-2.99|-9.89|
72400089|NCT03011307|144308034|SUPERIORITY|A likelihood-ratio test for change in pain was conducted for each outcome comparing a model with and without oxytocin treatment group. A statistically significant result is interpreted as evidence to support that the oxytocin treatment impacts some element of change after surgery (i.e, intercept or slope).|Intercept Difference in Daily Steps|-402.0||||0.41|TWO_SIDED|95.0|-1358.0|553.0||P value not adjusted for multiple comparisons, with threshold of statistical significance set at \<0.05|Mixed Models Analysis|||The estimates were conducted using a linear mixed effects model contrasting differences in the oxytocin group versus placebo. In all cases, these differences are adjusted for prognostic variables including baseline pain, baseline opioid use, age, sex, baseline PROMIS depression and number of other painful conditions.||553|-1358|0.41
72566535|NCT00486018|144663339|SUPERIORITY_OR_OTHER||Difference in Least Squares means|3.8||||0.0248||95.0|0.5|7.0|||ANCOVA|Pairwise ANCOVA models adjusted for baseline visual acuity score (≤ 34, 35-54, ≥ 55 letters) and baseline Distance Activities Subscale score.||||7.0|0.5|0.0248
72566536|NCT00486018|144663339|SUPERIORITY_OR_OTHER||Difference in Least Squares means|5.1||||0.0014||95.0|2.0|8.3|||ANCOVA|Pairwise ANCOVA models adjusted for baseline visual acuity score (≤ 34, 35-54, ≥ 55 letters) and baseline Distance Activities Subscale score.||||8.3|2.0|0.0014
72478907|NCT04227704|144483855|SUPERIORITY|||||||0.08|||||||ANOVA|||||||0.08
72478908|NCT04227704|144483862|SUPERIORITY|||||||0.44|||||||ANOVA|||||||0.44
72478909|NCT00112047|144483863|NON_INFERIORITY_OR_EQUIVALENCE|Assuming 70% response rate for each group at Week 48, 500 participants (250 per group) were sufficient to achieve at least 85% power to establish non-inferiority between the 2 study groups with a delta of 13%. The definition of clinical non-inferiority used a 'delta' of 0.13 (response rate was expressed as a decimal-valued number between 0 and 1). The EFV+FTC+TDF group was declared non-inferior to the CBV+EFV group if the lower confidence bound was \> -0.13.|Difference in percentages|11.4||||0.002|TWO_SIDED|95.0|4.3|18.6||The difference and 95% CI are stratum-weighted on baseline CD4 using normal approximation. The p-value for the superiority test is from the Cochran-Mantel-Haenzel test stratified on baseline CD4 cell count.|Cochran-Mantel-Haenszel|No other adjustments were made.||"Null Hypothesis: the percentage of responders (who achieved and maintained confirmed HIV-1 RNA \< 400 c/mL \[defined by the TLOVR algorithm\]) through Week 48 in the EFV+FTC+TDF group is more than 13% worse than in the CBV+EFV group.~Alternative Hypothesis: the percentage of responders who achieved and maintained confirmed HIV-1 RNA \< 400 c/mL \[defined by the TLOVR algorithm\]) through Week 48 in the EFV+FTC+TDF group is no more than 13% worse than in the CBV+EFV group."||18.6|4.3|0.002
72478910|NCT00112047|144483864|NON_INFERIORITY_OR_EQUIVALENCE|The definition of clinical non-inferiority used a 'delta' of 0.13 (response rate was expressed as a decimal-valued number between 0 and 1). The EFV+FTC+TDF group was declared non-inferior to the CBV+EFV group if the lower confidence bound was \> -0.13.|Difference in percentages|9.1||||0.021|TWO_SIDED|95.0|1.6|16.6||The difference and 95% CI are stratum-weighted on baseline CD4 using normal approximation. The p-value for the superiority test is from the Cochran-Mantel-Haenzel test stratified on baseline CD4 cell count.|Cochran-Mantel-Haenszel|No other adjustments were made.||"Null Hypothesis: the percentage of responders (who achieved and maintained confirmed HIV-1 RNA \< 50 c/mL \[defined by the TLOVR algorithm\]) through Week 48 in the EFV+FTC+TDF group is more than 13% worse than in the CBV+EFV group.~Alternative Hypothesis: the percentage of responders who achieved and maintained confirmed HIV-1 RNA \< 50 c/mL \[defined by the TLOVR algorithm\]) through Week 48 in the EFV+FTC+TDF group is no more than 13% worse than in the CBV+EFV group."||16.6|1.6|0.021
72478911|NCT00112047|144483865|NON_INFERIORITY_OR_EQUIVALENCE|The definition of clinical non-inferiority used a 'delta' of 0.13 (response rate was expressed as a decimal-valued number between 0 and 1). The EFV+FTC+TDF group was declared non-inferior to the CBV+EFV group if the lower confidence bound was \> -0.13.|Difference in percentages|11.2||||0.004|TWO_SIDED|95.0|3.7|18.6||The difference and 95% CI are stratum-weighted on baseline CD4 using normal approximation. The p-value for the superiority test is from the Cochran-Mantel-Haenzel test stratified on baseline CD4 cell count.|Cochran-Mantel-Haenszel|No other adjustments were made||Null hypothesis: The percentage of participants with HIV-1 RNA \< 400 c/mL at Week 48 in the EFV+FTC+TDF group is more than 13% worse than the CBV+EFV group. Alternative hypothesis: The percentage of participants with HIV-1 RNA \< 400 c/mL at Week 48 in the EFV+FTC+TDF group is no more than 13% worse than the CBV+EFV group.||18.6|3.7|0.004
72478912|NCT00112047|144483866|NON_INFERIORITY_OR_EQUIVALENCE|The definition of clinical non-inferiority used a 'delta' of 0.13 (response rate was expressed as a decimal-valued number between 0 and 1). The EFV+FTC+TDF group was declared non-inferior to the CBV+EFV group if the lower confidence bound was \> -0.13.|Difference in percentages|7.9||||0.058|TWO_SIDED|95.0|0.1|15.6||The difference and 95% CI are stratum-weighted on baseline CD4 using normal approximation. The p-value for the superiority test is from the Cochran-Mantel-Haenzel test stratified on baseline CD4 cell count.|Cochran-Mantel-Haenszel|No other adjustments were made.||Null hypothesis: The percentage of participants with HIV-1 RNA \< 50 c/mL at Week 48 in the EFV+FTC+TDF group is more than 13% worse than the CBV+EFV group. Alternative hypothesis: The percentage of participants with HIV-1 RNA \< 50 c/mL at Week 48 in the EFV+FTC+TDF group is no more than 13% worse than the CBV+EFV group.||15.6|0.1|0.058
72566537|NCT02243293|144663341|NON_INFERIORITY|The non-inferiority of the rate of sustained virologic response at 12 weeks after treatment as compared to historical control (in genotype 2 (GT2) DAA-naive participants in Part 4, arm S) was analyzed; the lower confidence bound of the 2-sided 95% confidence interval (95% CI) for the percentage of participants with sustained virologic response at 12 weeks after treatment must exceed 89% to achieve noninferiority.|Percentage of Participants|98.5|||||TWO_SIDED|95.0|96.5|100.0|||||95% CI was calculated using the normal approximation to the binomial distribution.|||100.0|96.5|
72576834|NCT00261443|144680660|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.12||||0.465|TWO_SIDED|95.0|-0.43|0.2||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 12 Comparison||0.20|-0.43|0.465
72623567|NCT03895372|144777813|SUPERIORITY||Least Squares Mean Difference|-10.51|||||TWO_SIDED|90.0|-13.4|-7.62||||||The analysis was based on the data at Week 16.||-7.62|-13.40|
72623568|NCT03895372|144777813|SUPERIORITY||Least Squares Mean Difference|-10.81|||||TWO_SIDED|90.0|-13.68|-7.94||||||The analysis was based on the data at Week 16.||-7.94|-13.68|
72400090|NCT03011307|144308035|SUPERIORITY|A likelihood-ratio test for change in pain was conducted for each outcome comparing a model with and without oxytocin treatment group. A statistically significant result is interpreted as evidence to support that the oxytocin treatment impacts some element of change after surgery (i.e, intercept or slope).|Mean Difference (Final Values)|344.0|||<|0.001|TWO_SIDED|95.0|173.0|515.0||P value not adjusted for multiple comparisons, with threshold of statistical significance set at \<0.05|Slope Difference|||"The estimates were conducted using a linear mixed effects model contrasting differences in the oxytocin group versus placebo. In all cases, these differences are adjusted for prognostic variables including baseline pain, baseline opioid use, age, sex, baseline PROMIS depression and number of other painful conditions.~The slope is the number of daily steps divided by the natural log of time in days."||515|173|<0.001
72478913|NCT00112047|144483867|SUPERIORITY_OR_OTHER|||||||0.003||95.0||||The distribution of time to loss-of-virologic response was estimated using the Kaplan-Meier product limit method and compared between treatment groups using a baseline CD4 stratum-weighted log-rank test.|Log Rank|No other adjustments were made.||Null Hypothesis: The percentage of participants with Loss of Virologic Response through Week 48 is equal between the two treatment groups. Alternative hypothesis: The percentage of participants with Loss of Virologic Response through Week 48 is different between the two treatment groups.||||0.003
72478914|NCT00112047|144483868|SUPERIORITY_OR_OTHER|||||||0.046||95.0||||The distribution of time to loss-of-virologic response was estimated using the Kaplan-Meier product limit method and compared between treatment groups using a baseline CD4 stratum-weighted log-rank test.|Log Rank|No other adjustments were made.||Null hypothesis: The percentage of participants with Loss of Virologic Response through Week 48 is equal between the two treatment groups. Alternative hypothesis: The percentage of participants with Loss of Virologic Response through Week 48 is different between the two treatment groups.||||0.046
72478915|NCT00112047|144483869|SUPERIORITY_OR_OTHER|||||||0.026||95.0||||The distribution of pure virological failure was estimated using the Kaplan-Meier product limit method and compared between treatment groups using a baseline CD4 stratum-weighted log-rank test.|Log Rank|No other adjustments were made.||Null Hypothesis: The percentage of participants with pure virological failure (confirmed HIV-1 RNA \< 400 c/mL) at Week 48 is equal for the 2 treatment groups. Alternative Hypothesis: The percentage of participants with pure virological failure (confirmed HIV-1 RNA \< 400 c/mL) at Week 48 is different between the 2 treatment groups.||||0.026
72478916|NCT00112047|144483870|SUPERIORITY_OR_OTHER|||||||0.063||95.0||||The distribution of pure virological failure was estimated using the Kaplan-Meier product limit method and compared between treatment groups using a baseline CD4 stratum-weighted log-rank test.|Log Rank|No other adjustments were made.||Null Hypothesis: The percentage of participants with pure virological failure (confirmed HIV-1 RNA \< 50 c/mL) through Week 48 for the EFV+FTC+TDF and CBV+EFV groups are equal. Alternative Hypothesis: The percentage of participants with pure virological failure (confirmed HIV-1 RNA \< 50 c/mL) through Week 48 for the EFV+FTC+TDF and CBV+EFV groups are different.||||0.063
72478917|NCT00112047|144483871|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.05||||0.31|TWO_SIDED|95.0|-0.16|0.06||The change from baseline to Week 48 in HIV-1 RNA was compared between the 2 treatment groups using baseline CD4 stratum-weighted CI around the mean difference. P-value is from stratum-weighted Van Elteren test.|Van Elteren|No other adjustments were made.||Null Hypothesis: Changes from baseline through Week 48 in plasma HIV-1 RNA for the EFV+FTC+TDF and CBV+EFV groups are equal. Alternative hypothesis: Changes from baseline through Week 48 in plasma HIV-1 RNA for the EFV+FTC+TDF and CBV+EFV groups are different.||0.06|-0.16|0.31
72478918|NCT00112047|144483872|SUPERIORITY_OR_OTHER||stratum-weighted difference|31.74||||0.002||95.0|8.96|54.52||The change from baseline to Week 48 in HIV-1 RNA was compared between the 2 treatment groups using baseline CD4 stratum-weighted CI around the mean difference. P-value is from stratum weighted Van Elteren test.|Van Elteren|No other adjustments were made.||Null Hypothesis: Changes from baseline through Week 48 in CD4 cell count for the EFV+FTC+TDF and CBV+EFV groups are equal. Alternative hypothesis: Changes from baseline through Week 48 in CD4 cell count for the EFV+FTC+TDF and CBV+EFV groups are different.||54.52|8.96|0.002
72478919|NCT00112047|144483873|NON_INFERIORITY_OR_EQUIVALENCE|The definition of clinical non-inferiority used a 'delta' of 0.13 (response rate was expressed as a decimal-valued number between 0 and 1). The EFV+FTC+TDF group was declared non-inferior to the CBV+EFV group if the lower confidence bound was \> -0.13.|Difference in percentages|12.7||||0.004|TWO_SIDED|95.0|4.3|21.1||The difference and 95% CI are stratum weighted on baseline CD4 using normal approximation. The p-value for the superiority test is from Cochran-Mantel-Haenszel test stratified on baseline CD4 cell count.|Cochran-Mantel-Haenszel|No other adjustments were made.||"Null Hypothesis: the percentage of responders (who achieved and maintained confirmed HIV-1 RNA \< 400 c/mL \[defined by the TLOVR algorithm\]) through Week 96 in the EFV+FTC+TDF group is more than 13% worse than in the CBV+EFV group.~Alternative Hypothesis: the percentage of responders who achieved and maintained confirmed HIV-1 RNA \< 400 c/mL \[defined by the TLOVR algorithm\]) through Week 96 in the EFV+FTC+TDF group is no more than 13% worse than in the CBV+EFV group."||21.1|4.3|0.004
72478920|NCT00112047|144483874|NON_INFERIORITY_OR_EQUIVALENCE|The definition of clinical non-inferiority used a 'delta' of 0.13 (response rate was expressed as a decimal-valued number between 0 and 1). The EFV+FTC+TDF group was declared non-inferior to the CBV+EFV group if the lower confidence bound was \> -0.13.|Difference in proportions|6.4||||0.158|TWO_SIDED|95.0|-2.3|15.0||The difference and 95% CI are stratum weighted on baseline CD4 using normal approximation. The p-value for the superiority test is from Cochran-Mantel-Haenszel test stratified on baseline CD4 cell count.|Cochran-Mantel-Haenszel|No other adjustments were made.||"Null Hypothesis: the percentage of responders (who achieved and maintained confirmed HIV-1 RNA \< 50 c/mL \[defined by the TLOVR algorithm\]) through Week 96 in the EFV+FTC+TDF group is more than 13% worse than in the CBV+EFV group.~Alternative Hypothesis: the percentage of responders who achieved and maintained confirmed HIV-1 RNA \< 50 c/mL \[defined by the TLOVR algorithm\]) through Week 96 in the EFV+FTC+TDF group is no more than 13% worse than in the CBV+EFV group."||15.0|-2.3|0.158
72478921|NCT00112047|144483875|SUPERIORITY_OR_OTHER|||||||0.003||95.0||||The distribution of time to loss-of-virologic response was estimated using the Kaplan-Meier product limit method and compared between treatment groups using a baseline CD4 stratum-weighted log-rank test.|Log Rank|No other adjustments were made.||Null Hypothesis: Ther percentage of participants with loss of virologic response (confirmed HIV-1 RNA \< 400 c/mL) at Week 96 for the EFV+FTC+TDF and CBV+EFV groups are equal. Alternative Hypothesis: The percentage of participants with loss of virologic response (confirmed HIV-1 RNA \< 400 c/mL) at Week 96 for the EFV+FTC+TDF and CBV+EFV groups are different||||0.003
72566538|NCT02409329|144663364|SUPERIORITY|We performed an omnibus test of the treatment effect at 3 and 6 months using a robust variance-covariance based Wald statistic. We used ordinary least squares linear regression with Huber-White heteroscedasticity-consistent standard errors to obtain point estimates and 95% CIs for the intervention effect at each time.|Predicted mean difference|-0.313||||0.0493|TWO_SIDED|95.0|-0.61|-0.017||A priori threshold p\<.05.|GEE, Wald test|Adjusted for baseline values with cubic splines (3 knots).|6-month point estimate|Any REACH vs. Helpline and A1c results. We used generalized estimating equations (GEE) with a working-exchangeable correlation structure and identity link, adjusting for baseline and allowing a time-treatment interaction. For the HbA1c model, we allowed for a three-way interaction between time, treatment group, and baseline HbA1c because there was descriptive evidence that the effect was modified by baseline HbA1c values. Multiply imputed data (m=1,000) using chained equations.||-0.017|-0.610|.0493
72576835|NCT00261443|144680660|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.29||||0.068|TWO_SIDED|95.0|-0.59|0.02||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 16 Comparison||0.02|-0.59|0.068
72623569|NCT01472185|144777825|SUPERIORITY_OR_OTHER||difference in least squares mean (LSM)|-0.56|||<|0.0001|TWO_SIDED|95.0|-0.76|-0.36||P-value is from a mixed effects model including terms for baseline HbA1c value, treatment group, visit week, and treatment by visit week interaction. Unstructured covariance matrix was used.|Mixed Effects Model Analysis||The estimation (LSM) is of the placebo-corrected change from baseline.|Assuming a common standard deviation of 1.2%, an effective sample size of 400 would provide at least 90% power to detect a statistically significant treatment difference of -0.5% (ranolazine vs. placebo) for the reduction of HbA1c from baseline at Week 24 based on a 2-sided alpha of 0.05 and 1:1 randomization.||-0.36|-0.76|< 0.0001
72478922|NCT00112047|144483876|SUPERIORITY_OR_OTHER|||||||0.124||95.0||||The distribution of time to loss-of-virologic response was estimated using the Kaplan-Meier product limit method and compared between treatment groups using a baseline CD4 stratum-weighted log-rank test.|Log Rank|No other adjustments were made.||Null Hypothesis: The percentage of participants with loss of virologic response (confirmed HIV-1 RNA \< 50 c/mL) through Week 96 for the EFV+FTC+TDF and CBV+EFV groups are equal. Alternative Hypothesis: The percentage of participants with loss of virologic response (confirmed HIV-1 RNA \< 50 c/mL) through Week 96 for the EFV+FTC+TDF and CBV+EFV groups are different||||0.124
72478923|NCT00112047|144483877|SUPERIORITY_OR_OTHER|||||||0.025||95.0||||The distribution of pure virological failure was estimated using the Kaplan-Meier product limit method and compared between treatment groups using a baseline CD4 stratum-weighted log-rank test.|Log Rank|No other adjustments were made.||Null Hypothesis: The percentage of participants with pure virological failure (confirmed HIV-1 RNA \< 400 c/mL) at Week 96 is equal for the 2 treatment groups. Alternative Hypothesis: The percentage of participants with pure virological failure (confirmed HIV-1 RNA \< 400 c/mL) at Week 96 is different between the 2 treatment groups.||||0.025
72478924|NCT00112047|144483878|SUPERIORITY_OR_OTHER|||||||0.41||95.0||||The distribution of pure virological failure was estimated using the Kaplan-Meier product limit method and compared between treatment groups using a baseline CD4 stratum-weighted log-rank test.|Log Rank|No other adjustments were made.||Null Hypothesis: The percentage of participants with pure virological failure (HIV-1 RNA \< 50 c/mL) through Week 96 for the EFV+FTC+TDF and CBV+EFV groups are equal. Alternative Hypothesis: The percentage of participants with pure virological failure (HIV-1 RNA \< 50 c/mL) through Week 96 for the EFV+FTC+TDF and CBV+EFV groups are different||||0.41
72478925|NCT00112047|144483879|SUPERIORITY_OR_OTHER||stratum-weighted difference|-0.05||||0.45||95.0|-0.17|0.08||The change from baseline to Week 96 in HIV-1 RNA was compared between the 2 treatment groups using baseline CD4 stratum-weighted CI around the mean difference.|Van Elteren|No other adjustments were made.||Null Hypothesis: Changes from baseline through Week 96 in plasma HIV-1 RNA for the EFV+FTC+TDF and CBV+EFV groups are equal. Alternative hypothesis: Changes from baseline through Week 96 in plasma HIV-1 RNA for the EFV+FTC+TDF and CBV+EFV groups are different.||0.08|-0.17|0.45
72478926|NCT00112047|144483880|SUPERIORITY_OR_OTHER||stratum-weighted difference|32.93||||0.036||95.0|0.87|64.99||The change from baseline to Week 96 in CD4 cell count was compared between the 2 treatment groups using baseline CD4 stratum-weighted CI around the mean difference. P-value is from stratum weighted Van Elteren test.|Van Elteren|No other adjustments were made.||Null Hypothesis: Changes from baseline through Week 96 in CD4 cell count for the EFV+FTC+TDF and CBV+EFV groups are equal. Alternative hypothesis: Changes from baseline through Week 96 in CD4 cell count for the EFV+FTC+TDF and CBV+EFV groups are different.||64.99|0.87|0.036
72478927|NCT00112047|144483881|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The change from Week 48 to Week 96 in limb fat was compared between the 2 treatment groups; the P-value is from the Wilcoxon Rank Sum Test.|Wilcoxon Rank Sum Test|No other adjustments were made.||Null Hypothesis: Change from Week 48 to Week 96 in limb fat for the EFV+FTC+TDF and CBV+EFV groups are equal. Alternative hypothesis: Change from Week 48 to Week 96 in limb fat for the EFV+FTC+TDF and CBV+EFV groups are not equal||||<0.001
72478928|NCT00112047|144483882|SUPERIORITY_OR_OTHER|||||||0.025||95.0||||The change from Week 48 to Week 96 in trunk fat was compared between the 2 treatment groups; the P-value is from the Wilcoxon Rank Sum Test.|Wilcoxon Rank Sum test|No other adjustments were made.||Null Hypothesis: Changes from Week 48 to Week 96 in Trunk Fat for the EFV+FTC+TDF and CBV+EFV groups are equal. Alternative hypothesis: Changes from Week 48 to Week 96 in Trunk Fat for the EFV+FTC+TDF and CBV+EFV groups are different||||0.025
72623570|NCT02951481|144777838|SUPERIORITY|||||||0.56|||||||Chi-squared|||||||0.56
72623571|NCT02951481|144777839|SUPERIORITY|||||||0.55|TWO_SIDED|95.0|||||Fisher Exact|||||||0.55
72623572|NCT02951481|144777840|SUPERIORITY|||||||0.023|||||||Chi-squared|||||||0.023
72623573|NCT02951481|144777841|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
72478929|NCT00112047|144483883|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The change from Week 48 to Week 96 in trunk fat was compared between the 2 treatment groups; the P-value is from the Wilcoxon Rank Sum Test.|Wilcoxon Rank Sum test|No other adjustments were made.||Null Hypothesis: Changes from Week 48 to Week 96 in Total Body Fat for the EFV+FTC+TDF and CBV+EFV groups are equal. Alternative hypothesis: Changes from Week 48 to Week 96 in Total Body Fat for the EFV+FTC+TDF and CBV+EFV groups are different||||<0.001
72478930|NCT00112047|144483884|NON_INFERIORITY_OR_EQUIVALENCE|The definition of clinical non-inferiority used a 'delta' of 0.13 (response rate was expressed as a decimal-valued number between 0 and 1). The EFV+FTC+TDF group was declared non-inferior to the CBV+EFV group if the lower confidence bound was \> -0.13.|Difference in proportions|12.9||||0.004|TWO_SIDED|95.0|4.2|21.6||The difference and 95% CI are stratum weighted on baseline CD4 using normal approximation. The p-value for the superiority test is from Cochran-Mantel-Haenzel test.|Cochran-Mantel-Haenszel|No other adjustments were made.||"Null Hypothesis: the proportion of responders (who achieved and maintained confirmed HIV-1 RNA \< 400 c/mL \[defined by the TLOVR algorithm\]) through Week 144 in the EFV+FTC+TDF group is more than 13% worse than in the CBV+EFV group.~Alternative Hypothesis: the proportion of responders who achieved and maintained confirmed HIV-1 RNA \< 400 c/mL \[defined by the TLOVR algorithm\]) through Week 144 in the EFV+FTC+TDF group is no more than 13% worse than in the CBV+EFV group."||21.6|4.2|0.004
72478931|NCT00112047|144483885|NON_INFERIORITY_OR_EQUIVALENCE|The definition of clinical non-inferiority used a 'delta' of 0.13 (response rate was expressed as a decimal-valued number between 0 and 1). The EFV+FTC+TDF group was declared non-inferior to the CBV+EFV group if the lower confidence bound was \> -0.13.|Difference in proportions|8.1||||0.082|TWO_SIDED|95.0|-0.8|17.0||The difference and 95% CI are stratum weighted on baseline CD4 using normal approximation. The p-value for the superiority test is from the Cochran-Mantel-Haenszel test stratified on baseline CD4 cell count.|Cochran-Mantel-Haenszel|No other adjustments were made.||"Null Hypothesis: the proportion of responders (who achieved and maintained confirmed HIV-1 RNA \< 50 c/mL \[defined by the TLOVR algorithm\]) through Week 144 in the EFV+FTC+TDF group is more than 13% worse than in the CBV+EFV group.~Alternative Hypothesis: the proportion of responders who achieved and maintained confirmed HIV-1 RNA \< 50 c/mL \[defined by the TLOVR algorithm\]) through Week 144 in the EFV+FTC+TDF group is no more than 13% worse than in the CBV+EFV group."||17.0|-0.8|0.082
72478932|NCT00112047|144483886|NON_INFERIORITY_OR_EQUIVALENCE|The definition of clinical non-inferiority used a 'delta' of 0.13 (response rate was expressed as a decimal-valued number between 0 and 1). The EFV+FTC+TDF group was declared non-inferior to the CBV+EFV group if the lower confidence bound was \> -0.13.|Difference in proportions|11.6||||0.009||95.0|3.1|20.1||The difference and 95% CI are stratum weighted on baseline CD4 using normal approximation. The p-value for the superiority test is from Cochran-Mantel-Haenzel test stratified on baseline CD4 cell count.|Cochran-Mantel-Haenszel|No other adjustments were made.||Null Hypothesis: The percentage of participants with HIV-1 RNA \< 400 c/mL at Week 144 in the EFV+FTC+TDF group is more than 13% worse than the CBV+EFV group. Alternative hypothesis: The percentage of participants with HIV-1 RNA \< 400 c/mL at Week 144 in the EFV+FTC+TDF group is no more than 13% worse than the CBV+EFV group.||20.1|3.1|0.009
72509203|NCT00431847|144548633|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.2518|STANDARD_ERROR_OF_MEAN|4.0583||0.1969|TWO_SIDED|95.0|-13.2466|2.743|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.||2.7430|-13.2466|0.1969
72509204|NCT00431847|144548633|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-12.9796|STANDARD_ERROR_OF_MEAN|6.5287||0.048|TWO_SIDED|95.0|-25.8429|-0.1162|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.||-0.1162|-25.8429|0.0480
72509205|NCT00431847|144548634|SUPERIORITY_OR_OTHER||Slope|-0.2349|STANDARD_ERROR_OF_MEAN|0.1003||0.0199|TWO_SIDED|95.0|-0.4323|-0.03745|||Mixed Models Analysis|||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group. The overall slope of the model (below) is reported as a continuous variable for time since injury.||-0.03745|-0.4323|0.0199
72509206|NCT00431847|144548634|SUPERIORITY_OR_OTHER||Chi-Squared|2.6||||0.4577|TWO_SIDED||||||Chi-squared|Degrees of Freedom: 3||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The time interaction component of the model is reported below.||||0.4577
72509207|NCT00431847|144548634|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.9502|STANDARD_ERROR_OF_MEAN|2.8797||0.7417|TWO_SIDED|95.0|-6.624|4.7236|||Mixed Models Analysis|||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.||4.7236|-6.6240|0.7417
72509208|NCT00431847|144548634|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.258|STANDARD_ERROR_OF_MEAN|4.4523||0.7778|TWO_SIDED|95.0|-7.5129|10.0289|||Mixed Models Analysis|||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.||10.0289|-7.5129|0.7778
72509209|NCT00431847|144548634|SUPERIORITY_OR_OTHER||Mean Difference (Net)|8.5232|STANDARD_ERROR_OF_MEAN|7.2532||0.2411|TWO_SIDED|95.0|-5.7608|22.8073|||Mixed Models Analysis|||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.||22.8073|-5.7608|0.2411
72623574|NCT02951481|144777842|SUPERIORITY|||||||0.5|||||||Chi-squared|||||||0.5
72478933|NCT00112047|144483887|NON_INFERIORITY_OR_EQUIVALENCE|The definition of clinical non-inferiority used a 'delta' of 0.13 (response rate was expressed as a decimal-valued number between 0 and 1). The EFV+FTC+TDF group was declared non-inferior to the CBV+EFV group if the lower confidence bound was \> -0.13.|Difference in proportions|10.4||||0.019|TWO_SIDED|95.0|1.8|19.0||The p-value for the superiority test is from Cochran-Mantel-Haenzel test stratified on baseline CD4 cell count.|Cochran-Mantel-Haenszel|No other adjustments were made.||Null hypothesis: The percentage of participants with HIV-1 RNA \< 50 c/mL at Week 144 in the EFV+FTC+TDF group is more than 13% worse than the CBV+EFV group. Alternative hypothesis: The percentage of participants with HIV-1 RNA \< 50 c/mL at Week 144 in the EFV+FTC+TDF group is no more than 13% worse than the CBV+EFV group.||19.0|1.8|0.019
72623575|NCT02951481|144777843|SUPERIORITY|||||||0.07|||||||Chi-squared|||||||0.07
72478934|NCT00112047|144483888|SUPERIORITY_OR_OTHER|||||||0.003||95.0||||The distribution of loss of virological response was estimated using the Kaplan-Meier product limit method and compared between treatment groups using a baseline CD4 stratum-weighted log-rank test.|Log Rank|No other adjustments were made.||Null Hypothesis: The percentage of participants with loss of virologic response (confirmed HIV-1 RNA \< 400 c/mL) through Week 144 for the EFV+FTC+TDF and CBV+EFV groups are equal. Alternative Hypothesis: The percentage of participants with loss of virologic response (confirmed HIV-1 RNA \< 400 c/mL) through Week 144 for the EFV+FTC+TDF and CBV+EFV groups are different||||0.003
72478935|NCT00112047|144483889|SUPERIORITY_OR_OTHER|||||||0.056||95.0||||The distribution of pure virological failure was estimated using the Kaplan-Meier product limit method and compared between treatment groups using a baseline CD4 stratum-weighted log-rank test.|Log Rank|No other adjustments were made.||Null Hypothesis: The percentage of participants with loss of virologic response (confirmed HIV-1 RNA \< 50 c/mL) through Week 144 for the EFV+FTC+TDF and CBV+EFV groups are equal. Alternative Hypothesis: The percentage of participants with loss of virologic response (confirmed HIV-1 RNA \< 50 c/mL) through Week 144 for the EFV+FTC+TDF and CBV+EFV groups are different||||0.056
72478936|NCT00112047|144483890|SUPERIORITY_OR_OTHER|||||||0.066||95.0||||The distribution of pure virological failure was estimated using the Kaplan-Meier product limit method and compared between treatment groups using a baseline CD4 stratum-weighted log-rank test.|Log Rank|No other adjustments were made.||Null Hypothesis: The percentage of participants with pure virological failure (confirmed HIV-1 RNA \< 400 c/mL) at Week 144 is equal for the 2 treatment groups. Alternative Hypothesis: The percentage of participants with pure virological failure (confirmed HIV-1 RNA \< 400 c/mL) at Week 144 is different between the 2 treatment groups||||0.066
72478937|NCT00112047|144483891|SUPERIORITY_OR_OTHER|||||||0.3||95.0||||The distribution of pure virological failure was estimated using the Kaplan-Meier product limit method and compared between treatment groups using a baseline CD4 stratum-weighted log-rank test.|Log Rank|No other adjustments were made.||Null Hypothesis: The percentage of participants with pure virological failure (confirmed HIV-1 RNA \< 50 c/mL) at Week 144 is equal for the 2 treatment groups. Alternative Hypothesis: The percentage of participants with pure virological failure (confirmed HIV-1 RNA \< 50 c/mL) at Week 144 is different between the 2 treatment groups||||0.30
72478938|NCT00112047|144483892|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.04||||0.39|TWO_SIDED|95.0|-0.16|0.08||The change from baseline to Week 144 in HIV-1 RNA was compared between the 2 treatment groups using baseline CD4 stratum-weighted CI around the mean difference. P-value is from a stratum weighted Van Elteren test.|Van Elteren|No other adjustments were made||Null Hypothesis: Changes from baseline to Week 144 in plasma HIV-1 RNA for the EFV+FTC+TDF and CBV+EFV groups are equal. Alternative hypothesis: Changes from baseline to Week 144 in plasma HIV-1 RNA for the EFV+FTC+TDF and CBV+EFV groups are different.||0.08|-0.16|0.39
72478939|NCT00112047|144483893|SUPERIORITY_OR_OTHER||Mean Difference (Net)|41.3||||0.089|TWO_SIDED|95.0|4.05|78.55||The change from baseline to Week 144 in CD4 cell count was compared between the 2 treatment groups using baseline CD4 stratum-weighted CI around the mean difference. P-value is from a stratum weighted Van Elteren test.|Van Elteren|No other adjustments were made||Null Hypothesis: Changes from baseline toWeek 144 in CD4 cell count for the EFV+FTC+TDF and CBV+EFV groups are equal. Alternative hypothesis: Changes from baseline to Week 144 in CD4 cell count for the EFV+FTC+TDF and CBV+EFV groups are different.||78.55|4.05|0.089
72478940|NCT00112047|144483894|SUPERIORITY_OR_OTHER|||||||0.001||95.0||||P-value is from the Wilcoxon Rank Sum Test|Wilcoxon Rank Sum test|No other adjustments were made||Null Hypothesis: Changes from Week 48 baseline to Week 144 in Limb Fat for the EFV+FTC+TDF and CBV+EFV groups are equal. Alternative hypothesis: Changes from Week 48 baseline to Week 144 in Limb Fat for the EFV+FTC+TDF and CBV+EFV groups are different||||0.001
72509210|NCT00431847|144548635|SUPERIORITY_OR_OTHER||Slope|0.1629|STANDARD_ERROR_OF_MEAN|0.08284||0.0504|TWO_SIDED|95.0|-0.00029|0.3261|||Mixed Models Analysis|||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group. The overall slope of the model (below) is reported as a continuous variable for time since injury.||0.3261|-0.00029|0.0504
72509211|NCT00431847|144548635|SUPERIORITY_OR_OTHER||Chi-Squared|1.45||||0.6942|TWO_SIDED||||||Chi-squared|Degrees of Freedom: 3||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The time interaction component of the model is reported below.||||0.6942
72509212|NCT00431847|144548635|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.5241|STANDARD_ERROR_OF_MEAN|2.4216||0.5297|TWO_SIDED|95.0|-3.2469|6.2951|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.||6.2951|-3.2469|0.5297
72623576|NCT02951481|144777844|SUPERIORITY|||||||0.47|||||||Chi-squared|||||||0.47
72623577|NCT02951481|144777845|SUPERIORITY|||||||0.29|||||||Fisher Exact|||||||0.29
72478941|NCT00112047|144483895|SUPERIORITY_OR_OTHER|||||||0.011||95.0||||P-value is from the Wilcoxon Rank Sum Test|Wilcoxon Rank Sum test|No other adjustments were made||Null Hypothesis: Changes from Week 48 baseline to Week 144 in Trunk Fat for the EFV+FTC+TDF and CBV+EFV groups are equal. Alternative hypothesis: Changes from Week 48 baseline to Week 144 in Trunk Fat for the EFV+FTC+TDF and CBV+EFV groups are different||||0.011
72478942|NCT00112047|144483896|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is from the Wilcoxon Rank Sum Test|Wilcoxon Rank Sum test|No other adjustments were made||Null Hypothesis: Changes from Week 48 baseline to Week 144 in Total Body Fat for the EFV+FTC+TDF and CBV+EFV groups are equal. Alternative hypothesis: Changes from Week 48 baseline to Week 144 in Total Body Fat for the EFV+FTC+TDF and CBV+EFV groups are different||||<0.001
72478943|NCT00112047|144483906|SUPERIORITY_OR_OTHER|||||||0.16||95.0||||P-value is from the Wilcoxon Signed Rank test. No adjustments for multiple comparisons were made|Wilcoxon Signed Rank test|||Null Hypothesis: Change from Week 144 (Atripla baseline) to Week 240 (Atripla Week 96) limb fat value is equal to zero. Alternative hypothesis: Change from Week 144 (Atripla baseline) to Week 240 (Atripla Week 96) limb fat value is not equal to zero.||||0.16
72478944|NCT00112047|144483907|SUPERIORITY_OR_OTHER|||||||0.049||95.0||||P-value is from the Wilcoxon Signed Rank test. No adjustments for multiple comparisons were made|Wilcoxon Signed Rank test|||Null Hypothesis: Change from Week 144 (Atripla baseline) to Week 240 (Atripla Week 96) trunk fat value is equal to zero. Alternative hypothesis: Change from Week 144 (Atripla baseline) to Week 240 (Atripla Week 96) trunk fat value is not equal to zero.||||0.049
72478945|NCT00112047|144483908|SUPERIORITY_OR_OTHER|||||||0.055||95.0||||P-value is from the Wilcoxon Signed Rank test. No adjustments for multiple comparisons were made|Wilcoxon Signed Rank test|||Null Hypothesis: Change from Week 144 (Atripla baseline) to Week 240 (Atripla Week 96) total body fat value is equal to zero. Alternative hypothesis: Change from Week 144 (Atripla baseline) to Week 240 (Atripla Week 96) total body fat value is not equal to zero.||||0.055
72478946|NCT00112047|144483909|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||"The number and proportion of participants in each category (very satisfied, not very satisfied) were summarized. The P-value for the category shift from Week 144 baseline within a treatment group was calculated using the McNemar test."|McNemar|||Null Hypothesis: There is no category shift from Week 144 (Atripla baseline) to Week 240 (Atripla Week 96). Alternative Hypothesis: There is a category shift from Week 144 (Atripla baseline) to Week 240 (Atripla Week 96).||||<0.001
72478947|NCT00112047|144483910|SUPERIORITY_OR_OTHER|||||||0.12||95.0||||"The number and proportion of participants in each category (very satisfied, not very satisfied) were summarized. The P-value for the category shift from Week 144 baseline within a treatment group was calculated using the McNemar test."|McNemar|||Null Hypothesis: There is no category shift from Week 144 (Atripla baseline) to Week 240 (Atripla Week 96). Alternative Hypothesis: There is a category shift from Week 144 (Atripla baseline) to Week 240 (Atripla Week 96).||||0.12
72478948|NCT00112047|144483911|SUPERIORITY_OR_OTHER|||||||0.037||95.0||||"The number and proportion of participants in each category (very satisfied, not very satisfied) were summarized. The P-value for the category shift from Week 144 baseline within a treatment group was calculated using the McNemar test."|McNemar|||Null Hypothesis: There is no category shift from Week 144 (Atripla baseline) to Week 240 (Atripla Week 96). Alternative Hypothesis: There is a category shift from Week 144 (Atripla baseline) to Week 240 (Atripla Week 96).||||0.037
72478949|NCT00112047|144483912|SUPERIORITY_OR_OTHER|||||||0.013||95.0||||"The number and proportion of participants in each category (very satisfied, not very satisfied) were summarized. The P-value for the category shift from Week 144 baseline within a treatment group was calculated using the McNemar test."|McNemar|||Null Hypothesis: There is no category shift from Week 144 (Atripla baseline) to Week 240 (Atripla Week 96). Alternative Hypothesis: There is a category shift from Week 144 (Atripla baseline) to Week 240 (Atripla Week 96).||||0.013
72478950|NCT00112047|144483913|SUPERIORITY_OR_OTHER|||||||0.7||95.0||||"The number and proportion of participants in each category (bothers, does not bother) were summarized. The P-value for the category shift from Week 144 baseline within a treatment group was calculated using the McNemar test."|McNemar|||Null Hypothesis: There is no category shift from Week 144 (Atripla baseline) to Week 240 (Atripla Week 96). Alternative Hypothesis: There is a category shift from Week 144 (Atripla baseline) to Week 240 (Atripla Week 96).||||0.70
72478951|NCT00112047|144483914|SUPERIORITY_OR_OTHER|||||||0.95||95.0||||P-value is from the Wilcoxon Signed Rank Test.|Wilcoxon Signed Rank Test|||Null Hypothesis: There is no change in the PCS score from Week 144 (Atripla baseline) to Week 240 (Atripla Week 96). Alternative Hypothesis: There is a change in the PCS score from Week 144 (Atripla baseline) to Week 240 (Atripla Week 96).||||0.95
72478952|NCT00112047|144483915|SUPERIORITY_OR_OTHER|||||||0.23||95.0||||P-value is from the Wilcoxon Signed Rank Test|Wilcoxon Signed Rank Test|||Null Hypothesis: There is no change in the MCS score from Week 144 (Atripla baseline) to Week 240 (Atripla Week 96). Alternative Hypothesis: There is a change in the MCS score from Week 144 (Atripla baseline) to Week 240 (Atripla Week 96).||||0.23
72478953|NCT00153062|144483925|NON_INFERIORITY_OR_EQUIVALENCE|The pre-defined non-inferiority margin of 1.075|Hazard Ratio (HR)|1.01||||0.783|TWO_SIDED|95.0|0.92|1.11|||Cox Proportional Hazard model|Cox proportional hazards model with age, baseline diabetes status, baseline ACE-I use, and baseline modified Rankin score as covariates||ASA+ER-DP vs clopidogrel||1.11|0.92|0.7830
72478954|NCT00153062|144483926|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.99||||0.8292|TWO_SIDED|95.0|0.92|1.07|||Cox Proportional Hazard model|Cox proportional hazards model with age, baseline diabetes status, baseline ACE-I use, and baseline modified Rankin score as covariates||ASA+ER-DP vs Clopidogrel||1.07|0.92|0.8292
72478955|NCT00153062|144483927|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.94||||0.1073|TWO_SIDED|95.0|0.87|1.01|||Cox Proportional Hazard model|Cox proportional hazards model with age, baseline diabetes status, baseline ACE-I use, and baseline modified Rankin score as covariates.||Telmisartan vs Placebo||1.01|0.87|0.1073
72478956|NCT00153062|144483928|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.82||||0.1007|TWO_SIDED|95.0|0.65|1.04|||Cox Proportional Hazard model|Cox proportional hazards model with age, baseline ACE-I use, and baseline modified Rankin score as covariates||Telmisartan vs Placebo||1.04|0.65|0.1007
72400091|NCT03011307|144308036|SUPERIORITY|A likelihood-ratio test for change in World Health Organization Disability Assessment Score 2.0 value was conducted for each outcome comparing a model with and without oxytocin treatment group. A statistically significant result is interpreted as evidence to support that the oxytocin treatment impacts some element of change after surgery (i.e, intercept or slope).|Intercept Difference: score on a scale|-5.9||||0.002|TWO_SIDED|95.0|-9.5|-2.3||P value not adjusted for multiple comparisons, with threshold of statistical significance set at \<0.05|Mixed Models Analysis|||The estimates were conducted using a linear mixed effects model contrasting differences in the oxytocin group versus placebo. In all cases, these differences are adjusted for prognostic variables including baseline World Health Organization Disability Assessment Score 2.0 value, baseline opioid use, age, sex, baseline PROMIS depression and number of other painful conditions.||-2.3|-9.5|0.002
72478957|NCT00153062|144483929|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.95||||0.2312|TWO_SIDED|95.0|0.86|1.04|||Cox Proportional Hazard model|Cox proportional hazards model with age, baseline diabetes status, baseline ACE-I use, and baseline Modified Rankin score as covariates||Telmisartan vs placebo||1.04|0.86|0.2312
72478958|NCT00275262|144483938|SUPERIORITY_OR_OTHER|||||||0.125|||||||ANOVA|The statistical method used for a 1-way ANOVA between treatment groups.||The final on treatment values were included in the analysis.||||0.125
72478959|NCT00275262|144483939|SUPERIORITY_OR_OTHER|||||||0.299|||||||ANOVA|The statistical method used for a 1-way ANOVA between treatment groups.||The final on treatment values were included in the analysis.||||0.299
72509213|NCT00431847|144548635|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.7679|STANDARD_ERROR_OF_MEAN|3.7464||0.3155|TWO_SIDED|95.0|-11.1478|3.612|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.||3.6120|-11.1478|0.3155
72509214|NCT00431847|144548635|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-9.7558|STANDARD_ERROR_OF_MEAN|6.092||0.1105|TWO_SIDED|95.0|-21.7515|2.2399|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.||2.2399|-21.7515|0.1105
72509215|NCT00431847|144548636|SUPERIORITY_OR_OTHER||Slope|-0.2979|STANDARD_ERROR_OF_MEAN|0.07538||0.001|TWO_SIDED|95.0|-0.4465|-0.1493|||Mixed Models Analysis|||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group. The overall slope of the model (below) is reported as a continuous variable for time since injury.||-0.1493|-0.4465|0.001
72509216|NCT00431847|144548636|SUPERIORITY_OR_OTHER||Chi-Squared|2.72||||0.4361|TWO_SIDED||||||Chi-squared|Degrees of Freedom: 3||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The time interaction component of the model is reported below.||||0.4361
72509217|NCT00431847|144548636|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.9001|STANDARD_ERROR_OF_MEAN|2.6015||0.7297|TWO_SIDED|95.0|-6.0247|4.2246|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.||4.2246|-6.0247|0.7297
72509218|NCT00431847|144548636|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.2896|STANDARD_ERROR_OF_MEAN|4.0186||0.2868|TWO_SIDED|95.0|-3.625|12.2043|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.||12.2043|-3.6250|0.2868
72509219|NCT00431847|144548636|SUPERIORITY_OR_OTHER||Mean Difference (Net)|9.0118|STANDARD_ERROR_OF_MEAN|6.2663||0.1516|TWO_SIDED|95.0|-3.327|21.3505|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.||21.3505|-3.3270|0.1516
72509220|NCT00431847|144548637|SUPERIORITY_OR_OTHER||Slope|-0.9776|STANDARD_ERROR_OF_MEAN|0.1426|<|0.0001|TWO_SIDED|95.0|-1.2584|-0.6967|||Mixed Models Analysis|||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group. The overall slope of the model (below) is reported as a continuous variable for time since injury. T||-0.6967|-1.2584|<0.0001
72509221|NCT00431847|144548637|SUPERIORITY_OR_OTHER||Chi-Squared|0.78||||0.8548|TWO_SIDED||||||Chi-squared|Degrees of Freedom: 3||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The time interaction component of the model is reported below.||||0.8548
72509222|NCT00431847|144548637|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.3635|STANDARD_ERROR_OF_MEAN|3.8899||0.3882|TWO_SIDED|95.0|-4.3026|11.0296|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.||11.0296|-4.3026|0.3882
72400092|NCT03011307|144308037|SUPERIORITY|A likelihood-ratio test for change in pain was conducted for each outcome comparing a model with and without oxytocin treatment group. A statistically significant result is interpreted as evidence to support that the oxytocin treatment impacts some element of change after surgery (i.e, intercept or slope).|Slope Difference|1.5||||0.001|TWO_SIDED|95.0|0.6|2.4||P value not adjusted for multiple comparisons, with threshold of statistical significance set at \<0.05|Mixed Models Analysis|||The estimates were conducted using a linear mixed effects model contrasting differences in the oxytocin group versus placebo. In all cases, these differences are adjusted for prognostic variables including baseline pain, baseline opioid use, age, sex, baseline PROMIS depression and number of other painful conditions.||2.4|0.6|0.001
72400093|NCT03011307|144308038|SUPERIORITY|A likelihood-ratio test for change in pain was conducted for each outcome comparing a model with and without oxytocin treatment group. A statistically significant result is interpreted as evidence to support that the oxytocin treatment impacts some element of change after surgery (i.e, intercept or slope).|Mean Difference (Final Values)|0.00035||||0.537|TWO_SIDED|95.0|-0.00085|0.0015||P value not adjusted for multiple comparisons, with threshold of statistical significance set at \<0.05|Intercept difference: Opioid probability|||The estimates were conducted using a linear mixed effects model contrasting differences in the oxytocin group versus placebo. In all cases, these differences are adjusted for prognostic variables including baseline opioid use, age, sex, baseline PROMIS depression and number of other painful conditions.||.0015|-.00085|0.537
72400094|NCT03011307|144308039|SUPERIORITY|A likelihood-ratio test for change in pain was conducted for each outcome comparing a model with and without oxytocin treatment group. A statistically significant result is interpreted as evidence to support that the oxytocin treatment impacts some element of change after surgery (i.e, intercept or slope).|Slope Difference: Opioid probability|-0.166||||0.01|TWO_SIDED|95.0|-0.172|-0.16||P value not adjusted for multiple comparisons, with threshold of statistical significance set at \<0.05|Mixed Models Analysis|||The estimates were conducted using a linear mixed effects model contrasting differences in the oxytocin group versus placebo. In all cases, these differences are adjusted for prognostic variables including baseline pain, baseline opioid use, age, sex, baseline PROMIS depression and number of other painful conditions.||-0.160|-0.172|0.010
72400095|NCT03011307|144308040|SUPERIORITY||Mean Difference (Net)|3.0|STANDARD_DEVIATION|14.0||0.55|TWO_SIDED||||||Regression, Linear|||Scores were compared statistically at baseline and 2 months between groups using a generalized linear model with time as a fixed factor.||||.55
72400096|NCT03011307|144308041|SUPERIORITY||Mean Difference (Net)|1.2|STANDARD_DEVIATION|2.2||0.46|TWO_SIDED||||||Regression, Linear|||Groups were compared over time from baseline to 2 months using a generalized linear model with time as a fixed factor.||||0.46
72400097|NCT03011307|144308042|SUPERIORITY||Mean Difference (Final Values)|0.24|STANDARD_DEVIATION|0.84||0.38|TWO_SIDED||||||Regression, Linear|||Groups were compared between preoperative and 2 month postoperative sessions using linear regression with time as a fixed factor.||||0.38
72400098|NCT03526458|144308043|SUPERIORITY||Mean Difference (Final Values)|16.6|STANDARD_ERROR_OF_MEAN|5.6||0.012|TWO_SIDED|95.0|4.4|28.9|||t-test, 2 sided|||||28.9|4.4|0.012
72400099|NCT03526458|144308044|SUPERIORITY||Mean Difference (Final Values)|11.3|STANDARD_ERROR_OF_MEAN|7.3||0.132|TWO_SIDED|95.0|-3.6|26.3|||t-test, 2 sided|||||26.3|-3.6|0.132
72400100|NCT03526458|144308045|SUPERIORITY||Mean Difference (Final Values)|1.2|STANDARD_ERROR_OF_MEAN|2.7||0.654|TWO_SIDED|95.0|-4.4|6.9|||t-test, 2 sided|||||6.9|-4.4|0.654
72400101|NCT03526458|144308046|SUPERIORITY|||||||0.299|||||||Chi-squared|||||||0.299
72400102|NCT03526458|144308047|SUPERIORITY|||||||0.076|||||||Chi-squared|||||||0.076
72478960|NCT00189488|144483977|SUPERIORITY_OR_OTHER||Adjusted Treatment Difference (%)|-17.9||||0.034|TWO_SIDED|95.0|-33.4|-2.4|||Cochran-Mantel-Haenszel|Adjusted for the stratification factors (TBI use, matched donor type, and source of donor cells) using the Cochran-Mantel-Haenszel weights.|The difference between treatment groups in the percentage of participants with Grade 2 to 4 acute GVHD, adjusted for the stratification factors (TBI use, matched donor type, and source of donor cells) using the Cochran-Mantel-Haenszel weights.|||-2.4|-33.4|0.034
72478961|NCT00189488|144483978|SUPERIORITY_OR_OTHER||Adjusted Difference (%)|0.5||||0.929|TWO_SIDED|95.0|-11.0|12.1|||Cochran-Mantel-Haenszel|Adjusted for the stratification factors (TBI use, matched donor type, and source of donor cells) using the Cochran-Mantel-Haenszel weights.|The difference between treatment groups in the percentage of participants with severe GVHD, adjusted for the stratification factors (TBI use, matched donor type, and source of donor cells) using the Cochran-Mantel-Haenszel weights.|||12.1|-11.0|0.929
72478962|NCT00189488|144483979|SUPERIORITY_OR_OTHER||Adjusted Treatment Difference (%)|-6.5||||0.352|TWO_SIDED|95.0|-19.4|6.4|||Cochran-Mantel-Haenszel|Adjusted for the stratification factors (TBI use, matched donor type, and source of donor cells) using the Cochran-Mantel-Haenszel weights.|The difference between treatment groups in the percentage of participants with Day 11 Methotrexate GVHD, adjusted for the stratification factors (TBI use, matched donor type, and source of donor cells) using the Cochran-Mantel-Haenszel weights.|||6.4|-19.4|0.352
72400103|NCT03526458|144308048|SUPERIORITY||Mean Difference (Final Values)|10.4|STANDARD_ERROR_OF_MEAN|143.9||0.943|TWO_SIDED|95.0|-286.0|306.8|||t-test, 2 sided|||||306.8|-286|0.943
72400104|NCT03526458|144308049|SUPERIORITY|||||||0.185|||||||Chi-squared|||||||0.185
72400105|NCT00529542|144308065|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.0||||0.58|TWO_SIDED|95.0|-9.3|5.3||All hypotheses tests were two-sided.|Linear mixed-effects models|Linear mixed-effects models were fit to continuous outcomes to assess the change from baseline to 6 weeks between groups.|This analysis revealed that the required sample size was 235 subjects per group for 80% power to detect an absolute 2% increase in FMD with Atorvastatin vs. Placebo. We stopped the trial because we had insufficient funds for the required sample size.|This study was initiated as a pilot study with the goal of enrolling 19 women in each group, which we hypothesized would provide 80% power to detect an absolute difference in the change in FMD from baseline between the two groups (Atorvastatin vs. Placebo) of 3.75%, assuming a common standard deviation (SD) of 4%, using a two-sided, two-sample t-test with α=0.05. Recruitment was slow due to strict inclusion/ exclusion criteria so we analyzed our data after the first 20 women completed the study.||5.3|-9.3|0.58
72400106|NCT00529542|144308066|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.7||||0.39|TWO_SIDED|95.0|-0.9|2.3|||Linear mixed-effects models|||"What is being compared for this analysis is the change from baseline for Atorvastatin to the change from baseline for Placebo."||2.3|-0.9|0.39
72478963|NCT00189488|144483980|SUPERIORITY_OR_OTHER||Adjusted Treatment Difference (%)|-2.6||||0.675|TWO_SIDED|95.0|-14.2|9.0|||Cochran-Mantel-Haenszel|Adjusted for the stratification factors (TBI use, matched donor type, and source of donor cells) using the Cochran-Mantel-Haenszel weights.|Difference between treatment groups in the percentage of participants with severe oral mucositis, adjusted for the stratification factors (TBI use, matched donor type, and source of donor cells) using the Cochran-Mantel-Haenszel weights.|"Participants with Unknown incidence are treated as Yes when constructing the differences, 95% confidence intervals and p-value."||9.0|-14.2|0.675
72478964|NCT00189488|144483981|SUPERIORITY_OR_OTHER||Adjusted Treatment Difference|0.5||||0.953|TWO_SIDED|95.0|-1.5|2.5|||Cochran-Mantel-Haenszel|Adjusted for the stratification factors (TBI use, matched donor type, and source of donor cells) using the Cochran-Mantel-Haenszel weights.|Adjusted for the stratification factors (TBI use, matched donor type, and source of donor cells) using the Cochran-Mantel-Haenszel weights.|||2.5|-1.5|0.953
72478965|NCT00189488|144483982|SUPERIORITY_OR_OTHER||Adjusted Treatment Difference (%)|2.0||||0.797|TWO_SIDED|95.0|-12.5|16.5|||Cochran-Mantel-Haenszel|Adjusted for the stratification factors (TBI use, matched donor type, and source of donor cells) using the Cochran-Mantel-Haenszel weights.|Difference between treatment groups in the percentage of participants with opioid analgesic use, adjusted for the stratification factors (TBI use, matched donor type, and source of donor cells) using the Cochran-Mantel-Haenszel weights.|||16.5|-12.5|0.797
72478966|NCT00189488|144483983|SUPERIORITY_OR_OTHER||Adjusted Treatment Difference|-5.5||||0.186|TWO_SIDED|95.0|-12.7|1.8|||Cochran-Mantel-Haenszel|Adjusted for the stratification factors (TBI use, matched donor type, and source of donor cells) using the Cochran-Mantel-Haenszel weights.|Adjusted for the stratification factors (TBI use, matched donor type, and source of donor cells) using the Cochran-Mantel-Haenszel weights.|||1.8|-12.7|0.186
72478967|NCT00189488|144483984|SUPERIORITY_OR_OTHER||Adjusted Treatment Difference|-4.1||||0.219|TWO_SIDED|5.0|-12.2|4.0|||Cochran-Mantel-Haenszel|Adjusted for the stratification factors (TBI use, matched donor type, and source of donor cells) using the Cochran-Mantel-Haenszel weights.|Adjusted for the stratification factors (TBI use, matched donor type, and source of donor cells) using the Cochran-Mantel-Haenszel weights.|||4.0|-12.2|0.219
72478968|NCT01878214|144484086|SUPERIORITY_OR_OTHER|||||||0.76|TWO_SIDED||||||Chi-squared|||||||0.76
72478969|NCT01878214|144484087|SUPERIORITY_OR_OTHER|||||||0.79|TWO_SIDED||||||Regression, Logistic|||||||0.79
72478970|NCT01878214|144484088|SUPERIORITY_OR_OTHER|||||||0.63|TWO_SIDED||||||Regression, Logistic|||Smoking frequency||||0.63
72478971|NCT01878214|144484088|SUPERIORITY_OR_OTHER|||||||0.3|TWO_SIDED||||||Regression, Logistic|||Smoking quantity||||0.30
72400107|NCT00529542|144308067|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-70.8|||<|0.001|TWO_SIDED|95.0|-95.2|-46.4|||Linear mixed-effects models|||"What is being compared for this analysis is the change from baseline for Atorvastatin to the change from baseline for Placebo."||-46.4|-95.2|<0.001
72478972|NCT01878214|144484089|SUPERIORITY_OR_OTHER|||||||0.28|TWO_SIDED||||||Regression, Logistic|||||||0.28
72478973|NCT01878214|144484090|SUPERIORITY_OR_OTHER|||||||0.09|TWO_SIDED||||||Regression, Logistic|||Motivation to quit||||0.09
72478974|NCT01878214|144484090|SUPERIORITY_OR_OTHER|||||||0.04|TWO_SIDED||||||Regression, Logistic|||Thinking about quitting||||0.04
72478975|NCT00946101|144484096|NON_INFERIORITY_OR_EQUIVALENCE|For the calculation of the power to rule out a 10% increase of fever rate in vaccine recipients with 300 evaluable subjects (240 vaccine and 60 placebo recipients), it is assumed that the true fever rate in the monovalent vaccine group is 3.0% to 8.0%,and the true fever rate in placebo group is 0% to 3% lower than the fever rate in the vaccine group.|rate difference|0.0|||||TWO_SIDED|95.0|-6.4|3.1|||score|||The rate of subjects with fever between the two treatment groups was compared based on the upper limit of the two-sided 95% exact confidence intervals for the rate difference (Vaccine minus Placebo). The upper limit of the two-sided 95% confidence intervals was evaluated against the pre-specified equivalence criterion of 10% which corresponds to the following hypotheses: H0 (null): rate difference ≥ 10%, HA (alternative): rate difference \< 10%||3.1|-6.4|
72478976|NCT00946101|144484097|SUPERIORITY_OR_OTHER||rate difference|1.5|||||TWO_SIDED|95.0|-12.8|9.8|||score|||The number of subjects who experienced a post-dose seroresponse was compared based on the upper limit of the two-sided 95% exact confidence intervals for the rate difference (Vaccine minus Placebo).||9.8|-12.8|
72478977|NCT00946101|144484098|SUPERIORITY_OR_OTHER||rate difference|4.9|||||TWO_SIDED|95.0|-9.6|13.8|||score|||The number of subjects who experienced a post-dose seroresponse was compared based on the upper limit of the two-sided 95% exact confidence intervals for the rate difference (Vaccine minus Placebo).||13.8|-9.6|
72478978|NCT00946101|144484099|SUPERIORITY_OR_OTHER||rate difference|17.5|||||TWO_SIDED|95.0|5.5|27.1|||score|||The number of subjects who experienced a post-dose seroresponse was compared based on the upper limit of the two-sided 95% exact confidence intervals for the rate difference (Vaccine minus Placebo).||27.1|5.5|
72478979|NCT00946101|144484100|SUPERIORITY_OR_OTHER||rate difference|5.1|||||TWO_SIDED|95.0|-8.4|17.6|||score|||Rates of solicited symptoms following each dose (Days 1 to 8 and Days 1 to 15) between the two treatment groups were compated following each dose. Exact two-sided 95% confidence intervals (Chan and Zhang, 1999) on the rate difference (Vaccine minus Placebo) were constructed. There were no prespecified equivalence criteria for the secondary analyses.||17.6|-8.4|
72400108|NCT00529542|144308068|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-57.6|||<|0.001|TWO_SIDED|95.0|-79.3|-35.9|||Linear mixed-effects models|||"What is being compared for this analysis is the change from baseline for Atorvastatin to the change from baseline for Placebo."||-35.9|-79.3|<0.001
72478980|NCT00946101|144484103|SUPERIORITY_OR_OTHER||rate difference|13.3|||||TWO_SIDED|95.0|-0.4|25.7|||score|||Rates of solicited symptoms following each dose (Days 1 to 8 and Days 1 to 15) between the two treatment groups were compared following each dose. Exact two-sided 95% confidence intervals (Chan and Zhang, 1999) on the rate difference (Vaccine minus Placebo) were constructed. There were no prespecified equivalence criteria for the secondary analyses.||25.7|-0.4|
72400109|NCT00529542|144308069|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.4||||0.26|TWO_SIDED|95.0|-2.7|9.5|||Linear mixed-effects models|||"What is being compared for this analysis is the change from baseline for Atorvastatin to the change from baseline for Placebo."||9.5|-2.7|0.26
72623578|NCT01051661|144777846|SUPERIORITY|The non-inferiority objective was met if the lower limit (LL) of the 95% CI for the Vaccine Efficacy Improvement (VEI) was \> -33%. Furthermore, the superiority objective was met if the LL of the 95% CI for the VEI was \>0.|Vaccine efficacy increase|76.7|||||TWO_SIDED|95.0|18.53|93.39||||||Evaluation of the relative protective efficacy of 2 doses of Arepanrix™ vaccine (Arepanrix 2D Group) compared to two doses of GSK2340273A vaccine (GSK2340273A Group) beginning 14 days after Dose 1 vaccination (for each subject enrolled) and continuing until study conclusion on Day 385.||93.39|18.53|
72623579|NCT01051661|144777874|OTHER||Adjusted GMT ratios|5.61|||||TWO_SIDED|95.0|4.92|6.41||||||Adjusted Geometric mean titer (GMT) ratios of Hemagglutination Inhibition (HI) antibody post vaccination between Arepanrix 2D Group and GSK2340273A Group for A/California influenza strain (Arepanrix 2D Group/GSK2340273A Group).||6.41|4.92|
72623580|NCT01051661|144777874|OTHER||Adjusted GMT ratios|1.05|||||TWO_SIDED|95.0|0.93|1.19||||||Adjusted Geometric mean titer (GMT) ratios of Hemagglutination Inhibition (HI) antibody post vaccination between Arepanrix 1D Group and GSK2340273A Group for A/California influenza strain (Arepanrix 1D Group/GSK2340273A Group).||1.19|0.93|
72400110|NCT00529542|144308070|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-82.2|||<|0.001|TWO_SIDED|95.0|-126.2|-38.1|||Linear mixed-effects models|||"What is being compared for this analysis is the change from baseline for Atorvastatin to the change from baseline for Placebo."||-38.1|-126.2|<0.001
72478981|NCT00946101|144484106|SUPERIORITY_OR_OTHER||rate difference|-6.3|||||TWO_SIDED|95.0|-19.7|6.1|||score|||Rates of solicited symptoms following each dose (Days 1 to 8 and Days 1 to 15) between the two treatment groups were compared following each dose. Exact two-sided 95% confidence intervals (Chan and Zhang, 1999) on the rate difference (Vaccine minus Placebo) were constructed. There were no prespecified equivalence criteria for the secondary analyses.||6.1|-19.7|
72478982|NCT00946101|144484109|SUPERIORITY_OR_OTHER||rate difference|-6.4|||||TWO_SIDED|95.0|-20.3|7.1|||score|||Rates of solicited symptoms following each dose (Days 1 to 8 and Days 1 to 15) between the two treatment groups were compared following each dose. Exact two-sided 95% confidence intervals (Chan and Zhang, 1999) on the rate difference (Vaccine minus Placebo) were constructed. There were no prespecified equivalence criteria for the secondary analyses.||7.1|-20.3|
72478983|NCT00946101|144484118|SUPERIORITY_OR_OTHER||rate difference|7.0|||||TWO_SIDED|95.0|-6.1|14.7|||score|||The number of subjects who achieved a post Dose 1 HAI titer greater than or equal to 32 against the H1N1 strain was compared based on the upper limit of the two-sided 95% exact confidence intervals for the rate difference (Vaccine minus Placebo).||14.7|-6.1|
72478984|NCT00946101|144484119|SUPERIORITY_OR_OTHER||rate difference|7.2|||||TWO_SIDED|95.0|-5.8|15.1|||score|||The number of subjects who achieved a post Dose 1 HAI titer greater than or equal to 32 against the H1N1 strain was compared based on the upper limit of the two-sided 95% exact confidence intervals for the rate difference (Vaccine minus Placebo).||15.1|-5.8|
72478985|NCT00946101|144484120|SUPERIORITY_OR_OTHER||rate difference|16.7|||||TWO_SIDED|95.0|5.9|25.2|||score|||The number of subjects who achieved a post Dose 2 HAI titer greater than or equal to 32 against the H1N1 strain was compared based on the upper limit of the two-sided 95% exact confidence intervals for the rate difference (Vaccine minus Placebo).||25.2|5.9|
72623581|NCT02412982|144777901|SUPERIORITY|||||||0.092|||||||Wilcoxon (Mann-Whitney)|||||||0.092
72623582|NCT00635050|144777907|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.28|||||TWO_SIDED|||||||||||||
72623583|NCT04011241|144777948|OTHER|Relative bioavailability|Ratio of the geometric means (T/R) %|173.71|||||TWO_SIDED|90.0|154.58|195.21|||ANOVA|"The statistical model was analysis of variance (ANOVA) on the logarithmic scale considering the effects subjects as random and treatment as fixed."|Intra-individual geometric coefficient of variation (gCV%) = 17.6.|||195.21|154.58|
72478986|NCT00069108|144484141|NON_INFERIORITY_OR_EQUIVALENCE|The pre-specified non-inferiority margin (1.30) was compared with the upper limit of the 95% confidence interval (CI) of the hazard ratio (HR, XELOX vs FOLFOX-4) in the population|Hazard Ratio (HR)|1.03||||0.00584|TWO_SIDED|95.0|0.87|1.24|||Chi-squared||The pre-specified non-inferiority margin (1.30) was compared with the upper limit of the 95% confidence interval (CI) of the hazard ratio (HR, XELOX vs FOLFOX-4) in the population|||1.24|0.87|0.00584
72478987|NCT00069108|144484142|NON_INFERIORITY_OR_EQUIVALENCE|While the study was not designed to demonstrate non-inferiority in PFS based on IRC assessments the pre-specified margin (1.30) was compared with the upper limit of the 95% confidence interval (CI) of the hazard ratio (HR, XELOX vs FOLFOX-4) in the population.|Hazard Ratio (HR)|0.93||||0.00223|TWO_SIDED|95.0|0.74|1.17|||Chi-squared||The pre-specified non-inferiority margin (1.30) was compared with the upper limit of the 95% confidence interval (CI) of the hazard ratio (HR, XELOX vs FOLFOX-4) in the population|||1.17|0.74|0.00223
72478988|NCT00069108|144484143|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.11|||||TWO_SIDED|95.0|0.91|1.37||||||||1.37|0.91|
72478989|NCT00069108|144484144|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.18|||||TWO_SIDED|95.0|0.95|1.47||||||||1.47|0.95|
72478990|NCT00069108|144484145|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.19||||0.4028|TWO_SIDED|95.0|0.79|1.77||p-value is for difference between response rates.|Chi-squared|||||1.77|0.79|0.4028
72478991|NCT00069108|144484146|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.28||||0.2911|TWO_SIDED|95.0|0.81|2.01||p-value is for difference between response rates.|Chi-squared|||||2.01|0.81|0.2911
72478992|NCT00069108|144484147|NON_INFERIORITY_OR_EQUIVALENCE|The pre-specified non-inferiority margin (1.30) was compared with the upper limit of the 95% CI of the hazard ratio (HR, XELOX vs FOLFOX-4) in the population.|Hazard Ratio (HR)|1.03|||||TWO_SIDED|95.0|0.87|1.23||||||||1.23|0.87|
72478993|NCT00069108|144484149|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.15|||||TWO_SIDED|95.0|0.79|1.68||||||||1.68|0.79|
72478994|NCT00069108|144484150|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.96|||||TWO_SIDED|95.0|0.81|1.12||||||||1.12|0.81|
72478995|NCT01415531|144484152|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-6.3|||<|0.0001|TWO_SIDED|95.0|-7.7|-4.8|||ANCOVA|||||-4.8|-7.7|<0.0001
72478996|NCT02054741|144484161|SUPERIORITY||Risk Ratio (RR)|0.74||||0.0001|TWO_SIDED|95.0|0.64|0.86|||Mixed Models Analysis|Generalized Linear Mixed Model||||0.86|0.64|0.0001
72478997|NCT02054741|144484162|SUPERIORITY||Hazard Ratio (HR)|1.13||||0.39|TWO_SIDED|95.0|0.85|1.5|||Regression, Cox|||||1.50|0.85|0.39
72623584|NCT04011241|144777949|OTHER|Relative bioavailability|Ratio of the geometric means (T/R) %|137.4|||||TWO_SIDED|90.0|120.84|156.24|||ANOVA|"The statistical model was analysis of variance (ANOVA) on the logarithmic scale considering the effects subjects as random and treatment as fixed."|Intra-individual geometric coefficient of variation (gCV%) = 19.4.|||156.24|120.84|
72400111|NCT00529542|144308071|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.3||||0.45|TWO_SIDED|95.0|-12.4|5.8|||Linear mixed-effects models|||"What is being compared for this analysis is the change from baseline for Atorvastatin to the change from baseline for Placebo."||5.8|-12.4|0.45
72478998|NCT02054741|144484163|SUPERIORITY||Risk Ratio (RR)|1.38||||0.015|TWO_SIDED|95.0|1.06|1.78|||Mixed Models Analysis|Generalized Linear Mixed Model||||1.78|1.06|0.015
72478999|NCT02344004|144484191|SUPERIORITY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||The proportion of participants achieving culture conversion by Month 6 was analyzed using the Cochran-Mantel-Haenszel test, stratified by smoking status and prior multi-drug regimen. The treatment comparison was tested at two-sided significance level of 0.05. The null hypothesis assumed that culture conversion by Month 6 is independent of treatment, and the alternative hypothesis assumed that culture conversion by Month 6 is associated with treatment.|The final analysis of the primary endpoint, the number of participants achieving culture conversion at by Month 6, was performed after the last participants completed Month 6 and his/her Month 6 sputum culture result was available.|||<0.0001
72479000|NCT02344004|144484192|SUPERIORITY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
72479001|NCT02344004|144484193|SUPERIORITY|||||||0.7804|||||||Mixed Model Repeated Measures (MMRM)|||This was analyzed using a mixed model repeated measures (MMRM) analysis of change from Baseline at Months 4\&6. MMRM included treatment, month, treatment-by-month interaction, combination of smoking status \& prior MDR (4 levels: Yes/Yes, Yes/No, No/Yes, and No/No) as fixed factors, baseline 6MWD as a covariate \& baseline 6MWD-by-month interaction. An unstructured covariance matrix was used for the MMRM.|"* Baseline is defined as the last non-missing value prior to first dose of study drug.~* Statistics were obtained from an mixed-effects model repeated measures (MMRM) model with pattern-mixture modeling of missing values due to dropout, which included treatment, month, the treatment-by-month interaction, and the combination of smoking status and prior multidrug regimen as fixed factors, the baseline 6MWT distance as a covariate and baseline 6MWT distance-by-month interaction. MMRM included postbaseline data through Month 6.~* For baseline, n is the number of participants with a baseline score and at least 1 postbaseline score. For Month 6, n is the number of participants with a baseline score and a postbaseline score at the summarized visit."|||0.7804
72479002|NCT02344004|144484194|SUPERIORITY||Cox Proportional Hazard|3.92|||<|0.0001|TWO_SIDED|95.0|2.01|7.63|||Regression, Cox|||Kaplan Meier estimates for the distribution of time to culture conversion were constructed for treatment arms. The treatment comparison was made using the stratified log rank test for the ITT population. The estimated median time to culture conversion for each treatment arm was not estimable. The time to culture conversion was analyzed using Cox regression model to estimate hazards ratio.||7.63|2.01|<0.0001
72479003|NCT02996565|144484214|SUPERIORITY||Mean Difference (Net)|-0.76||||0.45|TWO_SIDED|95.0|-2.84|1.33||The threshold for statistical significance was p = 0.05.|planned contrast|The planned contrast compares model-predicted change in SBP from index to 365 days in Telehealth Care vs. Best Practice Clinic-Based Care.|adjusted for baseline SBP, baseline DBP, baseline age, sex, Asian race|||1.33|-2.84|0.45
72479004|NCT02996565|144484215|SUPERIORITY|Random coefficients model predicted all EHR-documented DBPs from treatment group, days elapsed from index to each DBP (time) and treatment group by time with random clinic and patient intercepts.|Mean Difference (Net)|0.28||||0.64|TWO_SIDED|95.0|-0.95|1.51||The threshold for statistical significance was p\<0.05|planned contrast|The planned contrast compares the model-predicted change in DBP from index to 365 days in Telehealth care vs. index to 365 days in clinic based care.|adjusted for baseline SBP, baseline DBP, baseline age, sex, Asian race|||1.51|-0.95|0.64
72479005|NCT02996565|144484216|SUPERIORITY|Random coefficients model predicted baseline and 6 month patient-reported outcome from treatment group, time point and treatment group by time with random clinic intercept and patient scale parameter.|Risk Ratio (RR)|1.53|||<|0.001|TWO_SIDED|95.0|1.27|1.85||The threshold for statistical significance was p\<0.05|Mixed Models Analysis|The interaction RR compares the likelihood pf reporting high satisfaction at 6 months relative to baseline in Telehealth care vs. clinic based care|adjusted for baseline DBP, baseline age, sex|||1.85|1.27|<0.001
72479006|NCT02996565|144484217|SUPERIORITY|Random coefficients model predicted baseline and 6 month patient-reported outcome from treatment group, time point and treatment group by time with random clinic intercept and patient scale parameter.|Risk Ratio (RR)|1.25||||0.03|TWO_SIDED|95.0|1.02|1.52||The threshold for statistical significance was p\<0.05|Mixed Models Analysis|The interaction RR compares the likelihood pf reporting high satisfaction at 6 months relative to baseline in Telehealth care vs. clinic based care|adjusted for baseline DBP, baseline age, sex|||1.52|1.02|0.03
72479007|NCT02996565|144484218|SUPERIORITY|Random coefficients model predicted the likelihood that smoking was current 12 months by treatment group with random clinic intercept.|Risk Ratio (RR)|1.01||||0.73|TWO_SIDED|95.0|0.95|1.07||The threshold for statistical significance was p\<0.05|Mixed Models Analysis|The risk ratio compares the likelihood of current smoking at 12 months in Telehealth care vs. clinic based care|unadjusted|||1.07|0.95|0.73
72479008|NCT02996565|144484219|SUPERIORITY|Random coefficients model predicted baseline and 6 month patient-reported outcome from treatment group, time point and treatment group by time with random clinic intercept and patient scale parameter.|Risk Ratio (RR)|1.17||||0.08|TWO_SIDED|95.0|0.98|1.4||The threshold for statistical significance was p\<0.05|Mixed Models Analysis|The interaction RR compares the likelihood of reporting the side effect was a problem at 6m relative to baseline in Telehealth vs. clinic based care|adjusted for baseline DBP, baseline age, sex|||1.4|.98|0.08
72479009|NCT02996565|144484220|SUPERIORITY|Random coefficients model predicted baseline and 6 month patient-reported outcome from treatment group, time point and treatment group by time with random clinic intercept and patient scale parameter.|Risk Ratio (RR)|1.11||||0.18|TWO_SIDED|95.0|0.95|1.29||The threshold for statistical significance was p\<0.05|Mixed Models Analysis|The interaction RR compares the likelihood of reporting the side effect was a problem at 6m relative to baseline in Telehealth vs. clinic based care|adjusted for baseline DBP, baseline age, sex|||1.29|0.95|0.18
72479010|NCT02996565|144484221|SUPERIORITY|Random coefficients model predicted baseline and 6 month patient-reported outcome from treatment group, time point and treatment group by time with random clinic intercept and patient scale parameter.|Risk Ratio (RR)|0.98||||0.77|TWO_SIDED|95.0|0.87|1.11||The threshold for statistical significance was p\<0.05|Mixed Models Analysis|The interaction RR compares the likelihood of reporting the side effect was a problem at 6m relative to baseline in Telehealth vs. clinic based care|adjusted for baseline DBP, baseline age, sex|||1.11|0.87|0.77
72623585|NCT04011241|144777950|OTHER|Relative bioavailability|Ratio of the geometric means (T/R) %|168.64|||||TWO_SIDED|90.0|145.59|195.34|||ANOVA|"The statistical model was analysis of variance (ANOVA) on the logarithmic scale considering the effects subjects as random and treatment as fixed."|Intra-individual geometric coefficient of variation (gCV%) = 18.1.|||195.34|145.59|
72623586|NCT00086515|144777963|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.65|||<|0.001|TWO_SIDED|95.0|-0.77|-0.53|||ANCOVA|Model terms: treatment, prior AHA status (not on AHA, on monotherapy oral AHA, or on metformin-based oral combination AHA), and baseline A1C||||-0.53|-0.77|<0.001
72623587|NCT00086515|144777964|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-25.4|||<|0.001|TWO_SIDED|95.0|-31.0|-19.8|||ANCOVA|Model terms: treatment, prior AHA status (not on AHA, on monotherapy oral AHA, or on metformin-based oral combination AHA), and baseline FPG||||-19.8|-31.0|<0.001
72400112|NCT00529542|144308072|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.5||||0.33|TWO_SIDED|95.0|-2.8|7.9|||Linear mixed-effects models|||"What is being compared for this analysis is the change from baseline for Atorvastatin to the change from baseline for Placebo."||7.9|-2.8|0.33
72400113|NCT00529542|144308073|SUPERIORITY_OR_OTHER||Mean Difference (Net)|586.0||||0.61|TWO_SIDED|95.0|-1811.0|2983.0|||Linear mixed-effects models|||"What is being compared for this analysis is the change from baseline for Atorvastatin to the change from baseline for Placebo."||2983|-1811|0.61
72566539|NCT02409329|144663364|SUPERIORITY|We performed an omnibus test of the treatment effect at 3, 6, 12, and 15 months using a robust variance-covariance based Wald statistic. We used ordinary least squares linear regression with Huber-White heteroscedasticity-consistent standard errors to obtain point estimates and 95% CIs for the intervention effect at each time.|Predicted mean difference|-0.07||||0.26|TWO_SIDED|95.0|-0.38|0.24||A priori threshold p\<.05.|GEE, Wald test|Adjusted for baseline values with cubic splines (3 knots).|15-month point estimate|Any REACH vs. Helpline and A1c results. We used generalized estimating equations (GEE) with a working-exchangeable correlation structure and identity link, adjusting for baseline and allowing a time-treatment interaction. For the HbA1c model, we allowed for a three-way interaction between time, treatment group, and baseline HbA1c because there was descriptive evidence that the effect was modified by baseline HbA1c values. Multiply imputed data (m=1,000) using chained equations.||0.240|-0.380|0.260
72566540|NCT02409329|144663365|SUPERIORITY|We performed an omnibus test of the treatment effect at 3 and 6 months using a robust variance-covariance based Wald statistic. We used ordinary least squares linear regression with Huber-White heteroscedasticity-consistent standard errors to obtain point estimates and 95% CIs for the intervention effect at each time.|Predicted mean difference|0.406|||<|0.001|TWO_SIDED|95.0|0.196|0.615||A priori threshold p\<.05.|Wald statistic|Adjusted for baseline values with cubic splines (3 knots).|6-month point estimate|Any REACH vs. Helpline and A1c results. We used generalized estimating equations with a working-exchangeable correlation structure and identity link, adjusting for baseline and allowing a time-treatment interaction. Multiply imputed data (m=1,000) using chained equations.||0.615|0.196|<.001
72566541|NCT02409329|144663365|SUPERIORITY|We performed an omnibus test of the treatment effect at 3, 6, 12, and 15 months using a robust variance-covariance based Wald statistic. We used ordinary least squares linear regression with Huber-White heteroscedasticity-consistent standard errors to obtain point estimates and 95% CIs for the intervention effect at each time.|Predicted mean difference|0.21||||0.003|TWO_SIDED|95.0|-0.031|0.45||A priori threshold p\<.05.|GEE, Wald test|Adjusted for baseline values with cubic splines (3 knots).|15-month point estimate|Any REACH vs. Helpline and A1c results. We used generalized estimating equations (GEE) with a working-exchangeable correlation structure and identity link, adjusting for baseline and allowing a time-treatment interaction. For the HbA1c model, we allowed for a three-way interaction between time, treatment group, and baseline HbA1c because there was descriptive evidence that the effect was modified by baseline HbA1c values. Multiply imputed data (m=1,000) using chained equations.||0.450|-0.031|0.003
72566542|NCT02409329|144663366|SUPERIORITY|We performed an omnibus test of the treatment effect at 3 and 6 months using a robust variance-covariance based Wald statistic. We used ordinary least squares linear regression with Huber-White heteroscedasticity-consistent standard errors to obtain point estimates and 95% CIs for the intervention effect at each time.|Predicted mean difference|0.54||||0.376|TWO_SIDED|95.0|-0.012|1.09||A priori threshold p\<.05.|GEE, Wald test|Adjusted for baseline values with cubic splines (3 knots).|6-month point estimate|Any REACH vs. Helpline and A1c results. We used generalized estimating equations (GEE) with a working-exchangeable correlation structure and identity link, adjusting for baseline and allowing a time-treatment interaction. Multiply imputed data (m=1,000) using chained equations.||1.090|-0.012|0.376
72566543|NCT02409329|144663366|SUPERIORITY|We performed an omnibus test of the treatment effect at 3, 6, 12, and 15 months using a robust variance-covariance based Wald statistic. We used ordinary least squares linear regression with Huber-White heteroscedasticity-consistent standard errors to obtain point estimates and 95% CIs for the intervention effect at each time.|Predicted mean difference|0.278||||0.434|TWO_SIDED|95.0|-0.319|0.875||A priori threshold p\<.05.|GEE, Wald test|Adjusted for baseline values with cubic splines (3 knots).|15-month point estimate|Any REACH vs. Helpline and A1c results. We used generalized estimating equations (GEE) with a working-exchangeable correlation structure and identity link, adjusting for baseline and allowing a time-treatment interaction. Multiply imputed data (m=1,000) using chained equations.||0.875|-0.319|0.434
72623588|NCT00086515|144777965|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-50.6|||<|0.001|TWO_SIDED|95.0|-60.5|-40.8|||ANCOVA|Model terms: treatment, prior AHA status (not on AHA, on monotherapy oral AHA, or on metformin-based oral combination AHA), and baseline 2-hour PMG||||-40.8|-60.5|<0.001
72623589|NCT00049543|144777966|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.24||||0.14|TWO_SIDED|95.0|0.94|1.64|||Log Rank|||The Kaplan-Meier estimates of survival distribution for overall survival by treatment arm are reported, and the log rank test stratified by the stratification factors at randomization (exclude center) was used to compare the difference in the overall survival between two treatment arms. Hazard ratio of comparison of study treatment arm to placebo and it 95% C.I. were reported.||1.64|0.94|0.14
72400114|NCT00529542|144308074|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3385.0||||0.07|TWO_SIDED|95.0|-287.0|7056.0|||Linear mixed-effects models|||"What is being compared for this analysis is the change from baseline for Atorvastatin to the change from baseline for Placebo."||7056|-287|0.07
72566544|NCT02409329|144663367|SUPERIORITY|We performed an omnibus test of the treatment effect at 3 and 6 months using a robust variance-covariance based Wald statistic. We used ordinary least squares linear regression with Huber-White heteroscedasticity-consistent standard errors to obtain point estimates and 95% CIs for the intervention effect at each time.|Predicted mean difference|0.399||||0.0012|TWO_SIDED|95.0|0.16|0.637||A priori threshold p\<.05.|GEE, Wald test|Adjusted for baseline values with cubic splines (3 knots).|6-month point estimate|Any REACH vs. Helpline and A1c results. We used generalized estimating equations (GEE) with a working-exchangeable correlation structure and identity link, adjusting for baseline and allowing a time-treatment interaction. Multiply imputed data (m=1,000) using chained equations||0.637|0.160|0.0012
72566545|NCT02409329|144663367|SUPERIORITY|We performed an omnibus test of the treatment effect at 3, 6, 12, and 15 months using a robust variance-covariance based Wald statistic. We used ordinary least squares linear regression with Huber-White heteroscedasticity-consistent standard errors to obtain point estimates and 95% CIs for the intervention effect at each time.|Predicted mean difference|0.152||||0.003|TWO_SIDED|95.0|-0.121|0.426||A priori threshold p\<.05.|GEE, Wald test|Adjusted for baseline values with cubic splines (3 knots).|15-month point estimate|Any REACH vs. Helpline and A1c results. We used generalized estimating equations (GEE) with a working-exchangeable correlation structure and identity link, adjusting for baseline and allowing a time-treatment interaction. Multiply imputed data (m=1,000) using chained equations.||0.426|-0.121|0.003
72566546|NCT02409329|144663368|SUPERIORITY|We performed an omnibus test of the treatment effect at 3 and 6 months using a robust variance-covariance based Wald statistic. We used ordinary least squares linear regression with Huber-White heteroscedasticity-consistent standard errors to obtain point estimates and 95% CIs for the intervention effect at each time.|Predicted mean difference|-0.061||||0.632|TWO_SIDED|95.0|-0.218|0.095||A priori threshold p\<.05.|GEE, Wald test|Adjusted for baseline values with cubic splines (3 knots).|6-month point estimate|Any REACH vs. Helpline and A1c results. We used generalized estimating equations (GEE) with a working-exchangeable correlation structure and identity link, adjusting for baseline and allowing a time-treatment interaction. Multiply imputed data (m=1,000) using chained equations.||0.095|-0.218|0.632
72566547|NCT02409329|144663368|SUPERIORITY|We performed an omnibus test of the treatment effect at 3, 6, 12, and 15 months using a robust variance-covariance based Wald statistic. We used ordinary least squares linear regression with Huber-White heteroscedasticity-consistent standard errors to obtain point estimates and 95% CIs for the intervention effect at each time.|Predicted mean difference|0.005||||0.572|TWO_SIDED|95.0|-0.202|1.1||A priori threshold p\<.05.|GEE, Wald test|Adjusted for baseline values with cubic splines (3 knots).|15-month point estimate|Any REACH vs. Helpline and A1c results. We used generalized estimating equations (GEE) with a working-exchangeable correlation structure and identity link, adjusting for baseline and allowing a time-treatment interaction. Multiply imputed data (m=1,000) using chained equations.||1.100|-0.202|0.572
72566548|NCT02409329|144663369|SUPERIORITY|We performed an omnibus test of the treatment effect at 3 and 6 months using a robust variance-covariance based Wald statistic. We used ordinary least squares linear regression with Huber-White heteroscedasticity-consistent standard errors to obtain point estimates and 95% CIs for the intervention effect at each time.|Predicted mean difference|369.0||||0.703|TWO_SIDED|95.0|-142.0|881.0||A priori threshold p\<.05.|GEE, Wald test|Adjusted for baseline values with cubic splines (3 knots).|6-month point estimate|Any REACH vs. Helpline and A1c results. We used generalized estimating equations (GEE) with a working-exchangeable correlation structure and identity link, adjusting for baseline and allowing a time-treatment interaction. Multiply imputed data (m=1,000) using chained equations.||881|-142|0.703
72400115|NCT00529542|144308075|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.8||||0.88|TWO_SIDED|95.0|-24.1|27.8|||Linear mixed-effects models|||"What is being compared for this analysis is the change from baseline for Atorvastatin to the change from baseline for Placebo."||27.8|-24.1|0.88
72566549|NCT02409329|144663369|SUPERIORITY|We performed an omnibus test of the treatment effect at 3, 6, 12, and 15 months using a robust variance-covariance based Wald statistic. We used ordinary least squares linear regression with Huber-White heteroscedasticity-consistent standard errors to obtain point estimates and 95% CIs for the intervention effect at each time.|Predicted mean difference|26.0||||0.465|TWO_SIDED|95.0|-459.0|511.0||A priori threshold p\<.05.|GEE, Wald test|Adjusted for baseline values with cubic splines (3 knots).|15-month point estimate|Any REACH vs. Helpline and A1c results. We used generalized estimating equations (GEE) with a working-exchangeable correlation structure and identity link, adjusting for baseline and allowing a time-treatment interaction. Multiply imputed data (m=1,000) using chained equations.||511|-459|0.465
72400116|NCT00529542|144308076|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.1|||<|0.001|TWO_SIDED|95.0|-1.6|-0.5|||Linear mixed-effects models|||"What is being compared for this analysis is the change from baseline for Atorvastatin to the change from baseline for Placebo."||-0.5|-1.6|<0.001
72566550|NCT02409329|144663370|SUPERIORITY|Testing superiority of REACH only relative to control. We used ordinary least squares linear regression with Huber-White heteroscedasticity-consistent standard errors to obtain point estimates and 95% CIs for the intervention effect at each time.|Predicted mean difference|-0.75|||||TWO_SIDED|95.0|-1.38|-0.12|||||6-month point estimate|To evaluate if REACH only and REACH+FAMS had similar effects on HbA1c relative to control, we subsetted to participants with baseline HbA1c greater than or equal to 8.5% to maximize our power for these analyses. We used generalized estimating equations (GEE) with a working-exchangeable correlation structure and identity link, adjusting for baseline and allowing a time-treatment interaction. Multiply imputed data (m=1,000) using chained equations.||-0.12|-1.38|
72400117|NCT00529542|144308077|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-364.3||||0.02|TWO_SIDED|95.0|-655.3|-73.2|||Linear mixed-effects models|||"What is being compared for this analysis is the change from baseline for Atorvastatin to the change from baseline for Placebo."||-73.2|-655.3|0.02
72400118|NCT00529542|144308078|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.4||||0.21|TWO_SIDED|95.0|-6.4|1.5|||Linear mixed-effects models|||"What is being compared for this analysis is the change from baseline for Atorvastatin to the change from baseline for Placebo."||1.5|-6.4|0.21
72400119|NCT00529542|144308079|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.9||||0.27|TWO_SIDED|95.0|-16.9|5.0|||Linear mixed-effects models|||"What is being compared for this analysis is the change from baseline for Atorvastatin to the change from baseline for Placebo."||5.0|-16.9|0.27
72400120|NCT00529542|144308080|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-7.8||||0.05|TWO_SIDED|95.0|-15.8|0.1|||Linear mixed-effects models|||"What is being compared for this analysis is the change from baseline for Atorvastatin to the change from baseline for Placebo."||0.1|-15.8|0.05
72509223|NCT00431847|144548637|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.5029|STANDARD_ERROR_OF_MEAN|5.9044||0.9322|TWO_SIDED|95.0|-12.1376|11.1317|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.||11.1317|-12.1376|0.9322
72576836|NCT00261443|144680660|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.27||||0.095|TWO_SIDED|95.0|-0.58|0.05||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 20 Comparison||0.05|-0.58|0.095
72400121|NCT00529542|144308081|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.5||||0.48|TWO_SIDED|95.0|-6.8|13.7|||Linear mixed-effects models|||"What is being compared for this analysis is the change from baseline for Atorvastatin to the change from baseline for Placebo."||13.7|-6.8|0.48
72479011|NCT02996565|144484222|SUPERIORITY|Random coefficients model predicted baseline and 6 month patient-reported outcome from treatment group, time point and treatment group by time with random clinic intercept and patient scale parameter.|Risk Ratio (RR)|0.93||||0.32|TWO_SIDED|95.0|0.8|1.08||The threshold for statistical significance was p\<0.05|Mixed Models Analysis|The interaction RR compares the likelihood of reporting the side effect was a problem at 6m relative to baseline in Telehealth vs. clinic based care|adjusted for baseline DBP, baseline age, sex|||1.08|0.80|0.32
72479012|NCT02996565|144484223|SUPERIORITY|Random coefficients model predicted baseline and 6 month patient-reported outcome from treatment group, time point and treatment group by time with random clinic intercept and patient scale parameter.|Risk Ratio (RR)|0.95||||0.62|TWO_SIDED|95.0|0.76|1.19||The threshold for statistical significance was p\<0.05|Mixed Models Analysis|The interaction RR compares the likelihood of reporting the side effect was a problem at 6m relative to baseline in Telehealth vs. clinic based care|adjusted for baseline DBP, baseline age, sex|||1.19|0.76|0.62
72479013|NCT02996565|144484224|SUPERIORITY|Random coefficients model predicted baseline and 6 month patient-reported outcome from treatment group, time point and treatment group by time with random clinic intercept and patient scale parameter.|Risk Ratio (RR)|0.99||||0.87|TWO_SIDED|95.0|0.91|1.08||The threshold for statistical significance was p\<0.05|Mixed Models Analysis|The interaction RR compares the likelihood of reporting the side effect was a problem at 6m relative to baseline in Telehealth vs. clinic based care|adjusted for baseline DBP, baseline age, sex|||1.08|0.91|0.87
72479014|NCT02996565|144484225|SUPERIORITY|Random coefficients model predicted baseline and 6 month patient-reported outcome from treatment group, time point and treatment group by time with random clinic intercept and patient scale parameter.|Risk Ratio (RR)|0.95||||0.51|TWO_SIDED|95.0|0.82|1.11||The threshold for statistical significance was p\<0.05|Mixed Models Analysis|The interaction RR compares the likelihood of reporting the activity is helpful at 6m relative to baseline in Telehealth care vs. clinic based care|adjusted for baseline DBP, baseline age, sex|||1.11|0.82|0.51
72479015|NCT02996565|144484226|SUPERIORITY|Random coefficients model predicted baseline and 6 month patient-reported outcome from treatment group, time point and treatment group by time with random clinic intercept and patient scale parameter.|Risk Ratio (RR)|1.09||||0.41|TWO_SIDED|95.0|0.87|1.37||The threshold for statistical significance was p\<0.05|Mixed Models Analysis|The interaction RR compares the likelihood of reporting the activity is helpful at 6m relative to baseline in Telehealth care vs. clinic based care|adjusted for baseline DBP, baseline age, sex|||1.37|0.87|0.41
72479016|NCT02996565|144484227|SUPERIORITY|Random coefficients model predicted baseline and 6 month patient-reported outcome from treatment group, time point and treatment group by time with random clinic intercept and patient scale parameter.|Risk Ratio (RR)|0.9||||0.18|TWO_SIDED|95.0|0.77|1.06||The threshold for statistical significance was p\<0.05|Mixed Models Analysis|The interaction RR compares the likelihood of reporting the activity was helpful at 6m relative to baseline in Telehealth care vs. clinic based care|adjusted for baseline DBP, baseline age, sex|||1.06|0.77|0.18
72479017|NCT02996565|144484228|SUPERIORITY|Random coefficients model predicted baseline and 6 month patient-reported outcome from treatment group, time point and treatment group by time with random clinic intercept and patient scale parameter.|Risk Ratio (RR)|0.92||||0.31|TWO_SIDED|95.0|0.78|1.09||The threshold for statistical significance was p\<0.05|Mixed Models Analysis|The interaction RR compares the likelihood of reporting the activity is helpful at 6m relative to baseline in Telehealth care vs. clinic based care|adjusted for baseline DBP, baseline age, sex|||1.09|0.78|0.31
72509224|NCT00431847|144548637|SUPERIORITY_OR_OTHER||Mean Difference (Net)|21.1166|STANDARD_ERROR_OF_MEAN|9.2462||0.0233|TWO_SIDED|95.0|2.8992|39.3341|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.||39.3341|2.8992|0.0233
72400122|NCT00529542|144308082|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.2||||0.63|TWO_SIDED|95.0|-0.6|1.0|||Linear mixed-effects models|||"What is being compared for this analysis is the change from baseline for Atorvastatin to the change from baseline for Placebo."||1.0|-0.6|0.63
72509225|NCT01469013|144548638|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Regression, Logistic|||||||<0.001
72509226|NCT01469013|144548640|SUPERIORITY_OR_OTHER_LEGACY|||||||0.009|TWO_SIDED||||||Cochran-Armitage trend test|||||||0.009
72400123|NCT01082965|144308083|SUPERIORITY_OR_OTHER||Leasts Square (LS) Mean|-0.01|STANDARD_ERROR_OF_MEAN|0.265||0.9742|TWO_SIDED|95.0|-0.6|0.58||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Mixed model for repeated measures (MMRM) was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, Apolipoprotein E (ApoE) genotype, site as covariates.||0.58|-0.60|0.9742
72400124|NCT01082965|144308084|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.232||0.9638|TWO_SIDED|95.0|-0.51|0.49||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||0.49|-0.51|0.9638
72400125|NCT01082965|144308085|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.153||0.2548|TWO_SIDED|95.0|-0.53|0.16||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||0.16|-0.53|0.2548
72400126|NCT01082965|144308086|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.057||0.6316|TWO_SIDED|95.0|-0.18|0.12||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 4 on Day 1, Whole Brain Gray: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||0.12|-0.18|0.6316
72400127|NCT01082965|144308086|SUPERIORITY_OR_OTHER||LS Mean Difference|0.03|STANDARD_ERROR_OF_MEAN|0.063||0.6256|TWO_SIDED|95.0|-0.12|0.19||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 0 on Day 8, Whole Brain Gray: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||0.19|-0.12|0.6256
72400128|NCT01082965|144308086|SUPERIORITY_OR_OTHER||LS Mean Difference|0.03|STANDARD_ERROR_OF_MEAN|0.059||0.5847|TWO_SIDED|95.0|-0.12|0.19||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 4 on Day 8, Whole Brain Gray: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||0.19|-0.12|0.5847
72400129|NCT01082965|144308086|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.123||0.1555|TWO_SIDED|95.0|-0.46|0.09||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 4 on Day 1, Superior Temporal Cortex: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||0.09|-0.46|0.1555
72400130|NCT01082965|144308086|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.151||0.2416|TWO_SIDED|95.0|-0.51|0.14||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 0 on Day 8, Superior Temporal Cortex: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||0.14|-0.51|0.2416
72400131|NCT01082965|144308086|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.134||0.807|TWO_SIDED|95.0|-0.33|0.26||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 4 on Day 8, Superior Temporal Cortex: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||0.26|-0.33|0.8070
72400132|NCT01082965|144308086|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.189||0.6828|TWO_SIDED|95.0|-0.59|0.43||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 4 on Day 1, Medial Temporal Cortex: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||0.43|-0.59|0.6828
72400133|NCT01082965|144308086|SUPERIORITY_OR_OTHER||LS Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.109||0.8987|TWO_SIDED|95.0|-0.26|0.29||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 0 on Day 8, Medial Temporal Cortex: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||0.29|-0.26|0.8987
72479018|NCT02996565|144484229|SUPERIORITY|Random coefficients model predicted baseline and 6 month patient-reported outcome from treatment group, time point and treatment group by time with random clinic intercept and patient scale parameter.|Risk Ratio (RR)|1.04||||0.56|TWO_SIDED|95.0|0.89|1.22||The threshold for statistical significance was p\<0.05|Mixed Models Analysis|The interaction RR compares the likelihood of reporting the activity is helpful at 6m relative to baseline in Telehealth care vs. clinic based care|adjusted for baseline DBP, baseline age, sex|||1.22|0.89|0.56
72623590|NCT00049543|144777967|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.22||||0.15|TWO_SIDED|95.0|0.93|1.61||Stratified by stratification factors at randomization (except center)|Log Rank|Stratified by stratification factors at randomization (except center)||||1.61|0.93|0.15
72623591|NCT02106832|144777969|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.7062||||0.0511|TWO_SIDED|99.9|0.3928|1.2698|||Wald-type test|||The hazard ratio for time to first exacerbation event within 48 weeks and 99.9% Confidence Interval (CI) was calculated by using Cox proportional hazards model by comparison of Cipro 28/Pooled Placebo reporting groups. P-value was analysed using Wald-type test.||1.2698|0.3928|0.0511
72479019|NCT02996565|144484230|SUPERIORITY|Random coefficients model predicted baseline and 6 month patient-reported outcome from treatment group, time point and treatment group by time with random clinic intercept and patient scale parameter.|Risk Ratio (RR)|0.84||||0.08|TWO_SIDED|95.0|0.68|1.03||The threshold for statistical significance was p\<0.05|Mixed Models Analysis|The interaction RR compares the likelihood of reporting the burden was a problem at 6m relative to baseline in Telehealth care vs. clinic based care|adjusted for baseline DBP, baseline age, sex|||1.03|0.68|0.08
72623592|NCT02106832|144777977|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.8662||||0.3965|TWO_SIDED|95.1|0.6206|1.209|||Wald-type test|||The hazard ratio for time to first exacerbation event within 48 weeks and 95.1% Confidence Interval (CI) was calculated by using Cox proportional hazards model by comparison of Cipro 28/Pooled Placebo reporting groups. P-value was analysed using Wald-type test.||1.2090|0.6206|0.3965
72400134|NCT01082965|144308086|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.117||0.8922|TWO_SIDED|95.0|-0.28|0.25||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 4 on Day 8, Medial Temporal Cortex: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||0.25|-0.28|0.8922
72400135|NCT01082965|144308086|SUPERIORITY_OR_OTHER||LS Mean Difference|0.07|STANDARD_ERROR_OF_MEAN|0.203||0.7555|TWO_SIDED|95.0|-0.39|0.52||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 4 on Day 1, Inferior Temporal Cortex: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||0.52|-0.39|0.7555
72509227|NCT03161678|144548676|OTHER|The effect of CES1 genotype on agonist-stimulated change in platelet aggregation was calculated using variance component method that simultaneously adjusted for age, sex, body mass index (BMI), and relatedness among study participants. Relatedness among participants were accounted for by including a polygenic component as a random effect. Please see the Study Protocol and Statistical Analysis Plan document for additional information.|||||<|0.001|||||||Regression, Linear|All analyses were adjusted for age, sex, body mass index (BMI), and relatedness among study participants.||Change in platelet aggregation was assessed between the wild-type group and the carriers of the CES1 G143E mutation. The null hypothesis is that, following drug intervention, there is no difference in the change in platelet aggregation between genotype groups.||||<0.001
72509228|NCT03161678|144548676|OTHER|The effect of CES1 genotype on agonist-stimulated change in platelet aggregation was calculated using variance component method that simultaneously adjusted for age, sex, body mass index (BMI), and relatedness among study participants. Relatedness among participants were accounted for by including a polygenic component as a random effect. Please see the Study Protocol and Statistical Analysis Plan document for additional information.||||||0.24|||||||Regression, Linear|All analyses were adjusted for age, sex, body mass index (BMI), and relatedness among study participants.||Change in platelet aggregation was assessed between the wild-type group and the carriers of the CES1 functional mutation (rs7498748). The null hypothesis is that, following drug intervention, there is no difference in the change in platelet aggregation between genotype groups.||||0.24
72509229|NCT03161678|144548677|OTHER|The effect of CES1 genotype on agonist-stimulated change in platelet aggregation was calculated using variance component method that simultaneously adjusted for age, sex, body mass index (BMI), and relatedness among study participants. Relatedness among participants were accounted for by including a polygenic component as a random effect. Please see the Study Protocol and Statistical Analysis Plan document for additional information.||||||0.75|||||||Regression, Linear|All analyses were adjusted for age, sex, body mass index (BMI), and relatedness among study participants.||Change in platelet aggregation was assessed between the wild-type group and the carriers of the CES1 G143E mutation. The null hypothesis is that, following drug intervention, there is no difference in the change in platelet aggregation between genotype groups.||||0.75
72509230|NCT03161678|144548677|OTHER|The effect of CES1 genotype on agonist-stimulated change in platelet aggregation was calculated using variance component method that simultaneously adjusted for age, sex, body mass index (BMI), and relatedness among study participants. Relatedness among participants were accounted for by including a polygenic component as a random effect. Please see the Study Protocol and Statistical Analysis Plan document for additional information.||||||0.011|||||||Regression, Linear|All analyses were adjusted for age, sex, body mass index (BMI), and relatedness among study participants.||Change in platelet aggregation was assessed between the wild-type group and the carriers of the CES1 functional mutation (rs7498748). The null hypothesis is that, following drug intervention, there is no difference in the change in platelet aggregation between genotype groups.||||0.011
72623593|NCT00265122|144777989|SUPERIORITY_OR_OTHER|||||||0.337||95.0||||The P-Value is from a Cochran-Mantel-Haenszel (CMH) test stratified by the route of administration.|Cochran-Mantel-Haenszel|||Null hypothesis: No difference between ustekinumab and placebo at a significant level of 0.05.||||0.337
72623594|NCT00265122|144777991|SUPERIORITY_OR_OTHER|||||||0.292||95.0||||The P-Value is from a CMH test stratified by the route of administration.|Cochran-Mantel-Haenszel|||||||0.292
72623595|NCT03620981|144778008|SUPERIORITY||LS Mean Difference (Final Values)|-7.2|||<|0.0001|TWO_SIDED|95.0|-10.0|-4.3|||Mixed Models Analysis|||Statistical analysis to compare brexpiprazole 2 mg/day and placebo was performed at Week 10.||-4.3|-10.0|< 0.0001
72623596|NCT03620981|144778008|SUPERIORITY||LS Mean Difference (Final Values)|-3.7||||0.0175|TWO_SIDED|95.0|-6.8|-0.7|||Mixed Models Analysis|||Statistical analysis to compare brexpiprazole 1 mg/day and placebo was performed at Week 10.||-0.7|-6.8|0.0175
72623597|NCT03620981|144778009|SUPERIORITY||LS Mean Difference (Final Values)|-0.8|||<|0.0001|TWO_SIDED|95.0|-1.0|-0.5|||Mixed Models Analysis|||Statistical analysis to compare brexpiprazole 2 mg/day and placebo was performed at Week 10.||-0.5|-1.0|< 0.0001
72623598|NCT03620981|144778009|SUPERIORITY||LS Mean Difference (Final Values)|-0.3||||0.0083|TWO_SIDED|95.0|-0.6|-0.1|||Mixed Models Analysis|||Statistical analysis to compare brexpiprazole 1 mg/day and placebo was performed at Week 10.||-0.1|-0.6|0.0083
72479020|NCT02996565|144484231|SUPERIORITY|Random coefficients model predicted baseline and 6 month patient-reported outcome from treatment group, time point and treatment group by time with random clinic intercept and patient scale parameter.|Risk Ratio (RR)|0.9||||0.32|TWO_SIDED|95.0|0.73|1.11||The threshold for statistical significance was p\<0.05|Mixed Models Analysis|The interaction RR compares the likelihood of reporting the burden was a problem at 6m relative to baseline in Telehealth care vs. clinic based care|adjusted for baseline DBP, baseline age, sex|||1.11|.73|0.32
72479021|NCT02996565|144484232|SUPERIORITY|Random coefficients model predicted baseline and 6 month patient-reported outcome from treatment group, time point and treatment group by time with random clinic intercept and patient scale parameter.|Risk Ratio (RR)|1.14||||0.09|TWO_SIDED|95.0|0.98|1.33||The threshold for statistical significance was p\<0.05|Mixed Models Analysis|The interaction RR compares the likelihood of reporting the burden was a problem at 6m relative to baseline in Telehealth care vs. clinic based care|adjusted for baseline DBP, baseline age, sex|||1.33|0.98|0.09
72479022|NCT02996565|144484233|SUPERIORITY|Random coefficients model predicted baseline and 6 month patient-reported outcome from treatment group, time point and treatment group by time with random clinic intercept and patient scale parameter.|Risk Ratio (RR)|0.98||||0.77|TWO_SIDED|95.0|0.83|1.16||The threshold for statistical significance was p\<0.05|Mixed Models Analysis|The interaction RR compares the likelihood of reporting the burden was a problem at 6m relative to baseline in Telehealth care vs. clinic based care|adjusted for baseline DBP, baseline age, sex|||1.16|0.83|0.77
72479023|NCT02996565|144484234|SUPERIORITY|Random coefficients model predicted baseline and 6 month patient-reported outcome from treatment group, time point and treatment group by time with random clinic intercept and patient scale parameter.|Risk Ratio (RR)|1.21||||0.09|TWO_SIDED|95.0|0.97|1.5||The threshold for statistical significance was p\<0.05|Mixed Models Analysis|The interaction RR compares the likelihood of reporting the burden was a problem at 6m relative to baseline in Telehealth care vs. clinic based care|adjusted for baseline DBP, baseline age, sex|||1.5|.97|0.09
72479024|NCT02996565|144484235|SUPERIORITY|Random coefficients model predicted baseline and 6 month patient-reported outcome from treatment group, time point and treatment group by time with random clinic intercept and patient scale parameter.|Risk Ratio (RR)|0.64||||0.02|TWO_SIDED|95.0|0.45|0.92||The threshold for statistical significance was p\<0.05|Mixed Models Analysis|The interaction RR compares the likelihood of reporting the burden was a problem at 6m relative to baseline in Telehealth care vs. clinic based care|adjusted for baseline DBP, baseline age, sex|||0.92|0.45|0.02
72479025|NCT02996565|144484236|SUPERIORITY|Random coefficients model predicted baseline and 6 month patient-reported outcome from treatment group, time point and treatment group by time with random clinic intercept and patient scale parameter.|Risk Ratio (RR)|0.7||||0.006|TWO_SIDED|95.0|0.55|0.89||The threshold for statistical significance was p\<0.05|Mixed Models Analysis|The interaction RR compares the likelihood of reporting the burden was a problem at 6m relative to baseline in Telehealth care vs. clinic based care|adjusted for baseline DBP, baseline age, sex|||.89|.55|0.006
72479026|NCT02996565|144484237|SUPERIORITY|Random coefficients model predicted baseline and 6 month patient-reported outcome from treatment group, time point and treatment group by time with random clinic intercept and patient scale parameter.|Risk Ratio (RR)|0.78||||0.06|TWO_SIDED|95.0|0.6|1.01||The threshold for statistical significance was p\<0.05|Mixed Models Analysis|The interaction RR compares the likelihood of reporting the burden was a problem at 6m relative to baseline in Telehealth care vs. clinic based care|adjusted for baseline DBP, baseline age, sex|||1.01|0.60|0.06
72479027|NCT02996565|144484238|SUPERIORITY|Random coefficients model predicted baseline and 6 month patient-reported outcome from treatment group, time point and treatment group by time with random clinic intercept and patient scale parameter.|Risk Ratio (RR)|1.02||||0.65|TWO_SIDED|95.0|0.94|1.1||The threshold for statistical significance was p\<0.05|Mixed Models Analysis|The interaction RR compares the likelihood of reporting very/extremely confident at 6m relative to baseline in Telehealth care vs. clinic based care|adjusted for baseline DBP, baseline age, sex|||1.10|0.94|0.65
72479028|NCT02996565|144484239|SUPERIORITY|Random coefficients model predicted baseline and 6 month patient-reported outcome from treatment group, time point and treatment group by time with random clinic intercept and patient scale parameter.|Risk Ratio (RR)|1.02||||0.83|TWO_SIDED|95.0|0.83|1.25||The threshold for statistical significance was p\<0.05|Mixed Models Analysis|The interaction RR compares the likelihood of reporting very/extremely confident at 6m relative to baseline in Telehealth care vs. clinic based care|adjusted for baseline DBP, baseline age, sex|||1.25|0.83|0.83
72479029|NCT02996565|144484240|SUPERIORITY|Random coefficients model predicted baseline and 6 month patient-reported outcome from treatment group, time point and treatment group by time with random clinic intercept and patient scale parameter.|Risk Ratio (RR)|1.04||||0.41|TWO_SIDED|95.0|0.95|1.13||The threshold for statistical significance was p\<0.05|Mixed Models Analysis|The interaction RR compares the likelihood of reporting very/extremely confident at 6m relative to baseline in Telehealth care vs. clinic based care|adjusted for baseline DBP, baseline age, sex|||1.13|0.95|0.41
72479030|NCT02996565|144484241|SUPERIORITY|Random coefficients model predicted baseline and 6 month patient-reported outcome from treatment group, time point and treatment group by time with random clinic intercept and patient scale parameter.|Risk Ratio (RR)|1.04||||0.4|TWO_SIDED|95.0|0.94|1.16||The threshold for statistical significance was p\<0.05|Mixed Models Analysis|The interaction RR compares the likelihood of reporting very/extremely confident at 6m relative to baseline in Telehealth care vs. clinic based care|adjusted for baseline DBP, baseline age, sex|||1.16|0.94|0.40
72509231|NCT05022004|144548711|EQUIVALENCE|Type of Statistical Test - Therapeutic equivalence. Sample size was based on 90% power at an alpha=0.05 significance level when the true difference between the means is 0 and SD=3.5 and the 95% equivalence limits are -1.0 and 1.0; 20% dropout was assumed|Mean Difference (Final Values)|0.31|||||TWO_SIDED|95.0|-0.28|0.91|||||The reported mean difference represents value for Left Eye at Week 2, 08:00am|||0.91|-0.28|
72509232|NCT05022004|144548711|EQUIVALENCE|Type of Statistical Test - Therapeutic equivalence. Sample size was based on 90% power at an alpha=0.05 significance level when the true difference between the means is 0 and SD=3.5 and the 95% equivalence limits are -1.0 and 1.0; 20% dropout was assumed|Mean Difference (Final Values)|0.19|||||TWO_SIDED|95.0|-0.39|0.76|||||The reported mean difference represents value for Right Eye at Week 2, 08:00am|||0.76|-0.39|
72509233|NCT05022004|144548711|EQUIVALENCE|Type of Statistical Test - Therapeutic equivalence. Sample size was based on 90% power at an alpha=0.05 significance level when the true difference between the means is 0 and SD=3.5 and the 95% equivalence limits are -1.0 and 1.0; 20% dropout was assumed|Mean Difference (Final Values)|-0.04|||||TWO_SIDED|95.0|-0.59|0.5|||||The reported mean difference represents value for Left Eye at Week 6, 08:00am|||0.50|-0.59|
72566551|NCT02409329|144663370|SUPERIORITY|Testing superiority of REACH only relative to control. We used ordinary least squares linear regression with Huber-White heteroscedasticity-consistent standard errors to obtain point estimates and 95% CIs for the intervention effect at each time.|Predicted mean difference|-0.31|||||TWO_SIDED|95.0|-1.0|0.39|||||12-month point estimate|To evaluate if REACH only and REACH+FAMS had similar effects on HbA1c relative to control, we subsetted to participants with baseline HbA1c greater than or equal to 8.5% to maximize our power for these analyses. We used generalized estimating equations (GEE) with a working-exchangeable correlation structure and identity link, adjusting for baseline and allowing a time-treatment interaction. Multiply imputed data (m=1,000) using chained equations.||0.39|-1.00|
72623599|NCT03620981|144778010|SUPERIORITY||Mean Difference (Final Values)|-0.9|||<|0.0001|TWO_SIDED|95.0|-1.2|-0.6|||Cochran-Mantel-Haenszel|Cochran Mantel Haenszel (CMH), Last observation carried forward (LOCF)||Statistical analysis to compare brexpiprazole 2 mg/day and placebo was performed at Week 10.||-0.6|-1.2|< 0.0001
72509234|NCT05022004|144548711|EQUIVALENCE|Type of Statistical Test - Therapeutic equivalence. Sample size was based on 90% power at an alpha=0.05 significance level when the true difference between the means is 0 and SD=3.5 and the 95% equivalence limits are -1.0 and 1.0; 20% dropout was assumed|Mean Difference (Final Values)|-0.12|||||TWO_SIDED|95.0|-0.64|0.4|||||The reported mean difference represents value for Right Eye at Week 6, 08:00am|||0.40|-0.64|
72509235|NCT05022004|144548712|EQUIVALENCE|Type of Statistical Test - Therapeutic equivalence. Sample size was based on 90% power at an alpha=0.05 significance level when the true difference between the means is 0 and SD=3.5 and the 95% equivalence limits are -1.0 and 1.0; 20% dropout was assumed||||||0.0015||||||P value reported for Left Eye at Week 2; 08:00 am|two-sample t-test|||||||0.0015
72623600|NCT03620981|144778010|SUPERIORITY||Mean Difference (Final Values)|-0.5||||0.0052|TWO_SIDED|95.0|-0.8|-0.1|||Cochran-Mantel-Haenszel|CMH, LOCF||Statistical analysis to compare brexpiprazole 1 mg/day and placebo was performed at Week 10.||-0.1|-0.8|0.0052
72479031|NCT02996565|144484242|SUPERIORITY|Random coefficients model predicted baseline and 6 month patient-reported outcome from treatment group, time point and treatment group by time with random clinic intercept and patient scale parameter.|Risk Ratio (RR)|1.01||||0.74|TWO_SIDED|95.0|0.95|1.07||The threshold for statistical significance was p\<0.05|Mixed Models Analysis|The interaction RR compares the likelihood of reporting very/extremely confident at 6m relative to baseline in Telehealth care vs. clinic based care|adjusted for baseline DBP, baseline age, sex|||1.07|0.95|0.74
72479032|NCT02996565|144484243|SUPERIORITY|Random coefficients model predicted the likelihood that a new statin was current at 12 months by treatment group with random clinic intercept.|Risk Ratio (RR)|1.05||||0.71|TWO_SIDED|95.0|0.81|1.37||The threshold for statistical significance was p\<0.05|Mixed Models Analysis|The risk ratio compares the likelihood of a new statin medication that is current at 12 months in Telehealth care vs. clinic based care|adjusted for baseline SBP , baseline DBP, baseline age, sex, Asian race|||1.37|0.81|0.71
72479033|NCT00598273|144484247|NON_INFERIORITY_OR_EQUIVALENCE|A non-inferiority margin of -1.0 g/dL was used in the primary efficacy assessments. Non-inferiority was established if the lower limit of the two-sided 97.5% confidence interval for the difference between the means of the primary endpoint (peginesatide minus control ESA) was ≥ -1.0 g/dL.|Least Squares Mean Difference|0.03|STANDARD_ERROR_OF_MEAN|0.099|||TWO_SIDED|97.5|-0.19|0.26|||ANOVA|The ANOVA cell means model was used to estimate primary efficacy endpoint within the specified cells formed by the combination of treatment and strata||The sample size for this study was determined based on a two-group evaluation of non-inferiority in means with a non-inferiority margin (Δ) of -1.0 g/dL (one-sided significance level of 0.0125, or, comparably, a two-sided significance level of 0.025). A sample size of 450 (150 per treatment group) provided power greater than 99% for the evaluation of non-inferiority, assuming an expected treatment difference of 0.0 g/dL and a pooled standard deviation of 1.5 g/dL.||0.26|-0.19|
72479034|NCT00598273|144484247|NON_INFERIORITY_OR_EQUIVALENCE|A non-inferiority margin of -1.0 g/dL was used in the primary efficacy assessments. Non-inferiority was established if the lower limit of the two-sided 97.5% confidence interval for the difference between the means of the primary endpoint (peginesatide minus control ESA) was ≥ -1.0 g/dL.|Least Squares Mean Difference|0.26|STANDARD_ERROR_OF_MEAN|0.098|||TWO_SIDED|97.5|0.04|0.48|||ANOVA|The ANOVA cell means model was used to estimate primary efficacy endpoint within the specified cells formed by the combination of treatment and strata||The sample size for this study was determined based on a two-group evaluation of non-inferiority in means with a non-inferiority margin (Δ) of -1.0 g/dL (one-sided significance level of 0.0125, or, comparably, a two-sided significance level of 0.025). A sample size of 450 (150 per treatment group) provided power greater than 99% for the evaluation of non-inferiority, assuming an expected treatment difference of 0.0 g/dL and a pooled standard deviation of 1.5 g/dL.||0.48|0.04|
72479035|NCT00598273|144484248|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.25|||||TWO_SIDED|95.0|0.51|3.1|||Cochran-Mantel-Haenszel|||||3.10|0.51|
72479036|NCT00598273|144484248|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.48|||||TWO_SIDED|95.0|0.62|3.56|||Cochran-Mantel-Haenszel|||||3.56|0.62|
72479037|NCT00598273|144484249|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.99|||||TWO_SIDED|95.0|0.94|1.05|||Cochran-Mantel-Haenszel|||||1.05|0.94|
72479038|NCT00598273|144484249|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.0|||||TWO_SIDED|95.0|0.95|1.06|||Cochran-Mantel-Haenszel|||||1.06|0.95|
72479039|NCT02481947|144484265|NON_INFERIORITY|Non-inferiority margin = 12.6% (pre-specified)||||||0.016||||||The a priori threshold for statistical significance was 0.05.|Chi-squared|||||||0.016
72479040|NCT01815138|144484274|OTHER||Odds Ratio (OR)|0.05|||<|0.05|TWO_SIDED||||||Fisher Exact|||||||<0.05
72479041|NCT01815138|144484275|SUPERIORITY|||||||0.04|||||||t-test, 2 sided|||||||0.04
72479042|NCT03426267|144484277|OTHER||||||<|0.0001|||||||Chi-squared|||||||<.0001
72479043|NCT03426267|144484278|OTHER||||||<|0.0001|||||||Chi-squared|||||||<.0001
72479044|NCT00882687|144484285|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3235|||||||Wilcoxon rank-sum test|||||||0.3235
72479045|NCT00882687|144484285|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9144|||||||Wilcoxon rank-sum test|||||||0.9144
72479046|NCT00882687|144484285|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3324|TWO_SIDED||||||Wilcoxon rank-sum test|||||||0.3324
72479047|NCT00882687|144484286|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5846|TWO_SIDED||||||Wilcoxon rank-sum test|||||||0.5846
72479048|NCT00882687|144484286|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1493|TWO_SIDED||||||Wilcoxon rank-sum test|||||||0.1493
72479049|NCT00882687|144484286|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0404|TWO_SIDED||||||Wilcoxon rank-sum test|||||||0.0404
72479050|NCT00882687|144484287|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0578|TWO_SIDED||||||Wilcoxon rank-sum test|||||||0.0578
72479051|NCT00882687|144484287|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8988|TWO_SIDED||||||Wilcoxon rank-sum test|||||||0.8988
72479052|NCT00882687|144484287|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4709|TWO_SIDED||||||Wilcoxon rank-sum test|||||||0.4709
72479053|NCT00882687|144484288|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1773|TWO_SIDED||||||Wilcoxon rank-sum test|||||||0.1773
72479054|NCT00882687|144484288|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4222|TWO_SIDED||||||Wilcoxon rank-sum test|||||||0.4222
72623601|NCT04938427|144778026|SUPERIORITY||Hodges-Lehmann Location Shift Estimate|-1.17|||=|0.785|TWO_SIDED|95.0|-13.02|9.99||The p-value was calculated using Rank Analysis of Covariance (ANCOVA) model using treatment group, age stratum (≤6 years, \>6 years), and rank of Baseline seizure frequency per 28 days as predictors.|ANCOVA||The location shift between soticlestat and placebo (soticlestat - placebo) and its asymptotic 95% confidence interval (CI) are based on the Hodges-Lehmann estimation.|||9.99|-13.02|=0.785
72479055|NCT00882687|144484288|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4326|TWO_SIDED||||||Wilcoxon rank-sum test|||||||0.4326
72479056|NCT02649946|144484291|SUPERIORITY|TLPP evaluated at 6 months post-index procedure to assess if TLPP of COVERA is superior to that of PTA alone, by direct comparison.|||||<|0.001||||||Test successful if the one-side p-value is less than 0.025 and the result is in favor of the COVERA Vascular Covered Stent.|Chi-squared|||"Hypothesis: The (survival) rate in subjects treated with the COVERA Vascular Covered Stent (following PTA) with respect to TLPP through 6 months is greater than that in subjects treated with PTA alone in the treatment of stenoses in the upper extremity venous outflow of subjects dializing with an AV fistula.~Sample size calculation: 238 randomized subjects \[214 evaluable\] will give 92% power with one-sided type 1 error = 0.025."||||<0.001
72400136|NCT01082965|144308086|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|0.218||0.1928|TWO_SIDED|95.0|-0.18|0.79||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 0 on Day 8, Inferior Temporal Cortex: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||0.79|-0.18|0.1928
72400137|NCT01082965|144308086|SUPERIORITY_OR_OTHER||LS Mean Difference|0.12|STANDARD_ERROR_OF_MEAN|0.161||0.4946|TWO_SIDED|95.0|-0.26|0.49||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 4 on Day 8, Inferior Temporal Cortex: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||0.49|-0.26|0.4946
72479057|NCT02649946|144484292|NON_INFERIORITY|Non-inferiority Farrington and Manning Exact Test is used to test the primary safety hypothesis. The test is successful if the one-sided p-value is less than 0.025.||||||0.0022|||||||Farrington and Manning|Non-inferiority test with non-inferiority margin of 10%.||"Hypothesis: The safety rate in subjects treated with the COVERA Vascular Covered Stent (following PTA) is non-inferior to the safety rate in subjects treated with PTA alone through 30 days in the treatment of stenotic lesions.~Sample size: 238 randomized subjects \[226 evaluable\] will give 85% power with one-sided type 1 error = 0.025."||||0.0022
72479058|NCT01809002|144484338|NON_INFERIORITY|The primary endpoint tested non-inferiority as compared to collagen nerve cuff and superior to no treatment. Non-inferiority is defined as the lower limit of the 95% CI about the difference of \> -2 and the upper limit of the 95% CI for s2PD for Avance of \< 13 in ITT table.|Mean Difference (Net)|0.2|||||TWO_SIDED|95.0|-1.087|1.574|||ANCOVA|||The analysis was performed using a pre-defined standard statistical analysis with a non-response/failure assigned a worst-case scenario value of 16mm.||1.574|-1.087|
72479059|NCT01809002|144484339|SUPERIORITY|||||||0.035|||||||Wilcoxon (Mann-Whitney)|||||||0.035
72509236|NCT05022004|144548712|EQUIVALENCE|Type of Statistical Test - Therapeutic equivalence. Sample size was based on 90% power at an alpha=0.05 significance level when the true difference between the means is 0 and SD=3.5 and the 95% equivalence limits are -1.0 and 1.0; 20% dropout was assumed||||||0.0008|||||||two-sample t-test|P value reported for Right Eye at Week 2; 08:00am||||||0.0008
72509237|NCT05022004|144548712|EQUIVALENCE|Type of Statistical Test - Therapeutic equivalence. Sample size was based on 90% power at an alpha=0.05 significance level when the true difference between the means is 0 and SD=3.5 and the 95% equivalence limits are -1.0 and 1.0; 20% dropout was assumed|||||<|0.0001|||||||two-sample t-test|P value reported for left eye at week 6, 08:00 am||||||<.0001
72509238|NCT05022004|144548712|EQUIVALENCE|Type of Statistical Test - Therapeutic equivalence. Sample size was based on 90% power at an alpha=0.05 significance level when the true difference between the means is 0 and SD=3.5 and the 95% equivalence limits are -1.0 and 1.0; 20% dropout was assumed|||||<|0.0001|||||||two-sample t-test|P value reported for Right eye at Week 6; 08:00 am||||||<.0001
72400138|NCT01082965|144308086|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.196||0.7029|TWO_SIDED|95.0|-0.56|0.4||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 4 on Day 1, Medial Prefrontal Cortex: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||0.40|-0.56|0.7029
72400139|NCT01082965|144308086|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.171||0.1085|TWO_SIDED|95.0|-0.68|0.08||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 0 on Day 8, Medial Prefrontal Cortex: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||0.08|-0.68|0.1085
72479060|NCT01809002|144484339|SUPERIORITY|||||||0.365|||||||Wilcoxon (Mann-Whitney)|||||||0.365
72479061|NCT01809002|144484340|SUPERIORITY|||||||0.915||||||The number and percentage of all treated subjects who recovered s2PD in the target repair at Month 12 (i.e., s2PD of 2 - 15 mm) were summarized by repair type. Differences between the repair types were assessed using a logistic regression analysis.|Regression, Logistic|||Responders were defined as subjects achieving s2PD of 2-15 mm on the target nerve repair.||||0.915
72509239|NCT00374907|144548715|SUPERIORITY_OR_OTHER||Adjusted Percent Difference|18.5||||0.035|TWO_SIDED|95.0|1.3|38.7||Between-group comparisons significant at alpha = 0.05, significance testing based on hierarchical testing. Primary and secondary endpoints are presented in order of testing.|ANCOVA|Adjusted percent difference for saxagliptin 5 mg vs placebo in Week 12 (LOCF) to baseline ratio. Adjusted for baseline.|ANCOVA model: logarithm(post/pre) = logarithm(pre) treatment|||38.7|1.3|0.0350
72509240|NCT00374907|144548716|SUPERIORITY_OR_OTHER||Adjusted Percent Difference|27.9||||0.0204|TWO_SIDED|95.0|4.2|57.1||Between-group comparisons significant at alpha = 0.05, significance testing based on hierarchical testing. Primary and secondary endpoints are presented in order of testing.|ANCOVA|Adjusted percent difference for saxagliptin 5 mg vs placebo in Week 12 (LOCF) to baseline ratio. Adjusted for baseline.|ANCOVA model: logarithm(post/pre) = logarithm(pre) treatment|||57.1|4.2|0.0204
72509241|NCT01323673|144548743|SUPERIORITY_OR_OTHER|||||||0.151||95.0||||Cochran-Mantel-Haenszel (CMH) test stratified by center was used for analysis.|Cochran-Mantel-Haenszel|||||||0.151
72576837|NCT00261443|144680660|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.29||||0.082|TWO_SIDED|95.0|-0.62|0.04||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 24 Comparison||0.04|-0.62|0.082
72576838|NCT00261443|144680660|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.36||||0.033|TWO_SIDED|95.0|-0.69|-0.03||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 28 Comparison||-0.03|-0.69|0.033
72576839|NCT00261443|144680660|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.31||||0.062|TWO_SIDED|95.0|-0.64|0.02||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 32 Comparison||0.02|-0.64|0.062
72400140|NCT01082965|144308086|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.132||0.3588|TWO_SIDED|95.0|-0.44|0.18||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 4 on Day 8, Medial Prefrontal Cortex: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||0.18|-0.44|0.3588
72400141|NCT01082965|144308086|SUPERIORITY_OR_OTHER||LS Mean Difference|0.17|STANDARD_ERROR_OF_MEAN|0.151||0.3053|TWO_SIDED|95.0|-0.2|0.53||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 4 on Day 1, Inferior Prefrontal Cortex: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||0.53|-0.20|0.3053
72400142|NCT01082965|144308086|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.16||0.9861|TWO_SIDED|95.0|-0.36|0.36||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 0 on Day 8, Inferior Prefrontal Cortex: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||0.36|-0.36|0.9861
72400143|NCT01082965|144308086|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.14||0.6558|TWO_SIDED|95.0|-0.41|0.28||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 4 on Day 8, Inferior Prefrontal Cortex: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||0.28|-0.41|0.6558
72400144|NCT01082965|144308086|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.145||0.9471|TWO_SIDED|95.0|-0.53|0.51||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 4 on Day 1, Superior Prefrontal Cortex: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||0.51|-0.53|0.9471
72400145|NCT01082965|144308086|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.27|STANDARD_ERROR_OF_MEAN|0.186||0.2136|TWO_SIDED|95.0|-0.77|0.23||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 0 on Day 8, Superior Prefrontal Cortex: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||0.23|-0.77|0.2136
72479062|NCT01809002|144484341|SUPERIORITY||LS Means difference|-2.84|||||TWO_SIDED|95.0|-11.6316|5.9541||Pre-injury baseline was defined as s2PD in the contralateral digit associated with the target digit.|ANCOVA|This analysis was assessed in the ITT population, at Month 12 using the LS Mean differences from a repeated measures ANCOVA model.||||5.9541|-11.6316|
72479063|NCT01809002|144484342|SUPERIORITY|||||||0.792|||||||Kaplan-Meier median and 95% CI|Differences between the repair types were assessed with a KM log-rank test that was appropriate for the handing of interval-censored data.||||||0.792
72479064|NCT01809002|144484343|SUPERIORITY|||||||0.526|||||||Wilcoxon (Mann-Whitney)|This analysis was completed to detect a distribution shift of the MRCC score between repairs with PNA and repairs with nerve cuff at Month 12.||||||0.526
72400146|NCT01082965|144308086|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.189||0.6435|TWO_SIDED|95.0|-0.47|0.67||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 4 on Day 8, Superior Prefrontal Cortex: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||0.67|-0.47|0.6435
72479065|NCT01809002|144484344|OTHER||Mean Difference (Final Values)|-24.09|||||TWO_SIDED|||||||||"This analysis compares the change in 12 Month Pain VAS scores from Baseline. Missing or incomplete data was extrapolated using a pre-defined repeated measures modeling approach for calculations in this analysis.~This analysis assesses each treatment group for clinically meaningful improvement in VAS from Baseline assuming a Meaningful Clinically Important Difference delta of 20 points (mm)."||||
72576840|NCT00261443|144680660|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.43||||0.011|TWO_SIDED|95.0|-0.76|-0.1||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 36 Comparison||-0.10|-0.76|0.011
72400147|NCT01082965|144308086|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.086||0.0659|TWO_SIDED|95.0|-0.41|0.02||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 4 on Day 1, Inferior Parietal Cortex: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||0.02|-0.41|0.0659
72400148|NCT01082965|144308086|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.158||0.7687|TWO_SIDED|95.0|-0.41|0.31||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 0 on Day 8, Inferior Parietal Cortex: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||0.31|-0.41|0.7687
72400149|NCT01082965|144308086|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.32|STANDARD_ERROR_OF_MEAN|0.163||0.1061|TWO_SIDED|95.0|-0.73|0.1||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 4 on Day 8, Inferior Parietal Cortex: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||0.10|-0.73|0.1061
72479066|NCT01809002|144484346|SUPERIORITY|||||||0.012|||||||Wilcoxon (Mann-Whitney)|||||||0.012
72479067|NCT01809002|144484347|SUPERIORITY|||||||0.037|||||||Wilcoxon (Mann-Whitney)|This analysis was completed utilizing a one-sided Wilcoxon Rank Sum test.||||||0.037
72479068|NCT01809002|144484348|SUPERIORITY|||||||0.021|||||||Wilcoxon (Mann-Whitney)|One-sided Wilcoxon Rank Sum test was utilized for this analysis.||||||0.021
72400150|NCT01082965|144308086|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.124||0.3925|TWO_SIDED|95.0|-0.41|0.19||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 4 on Day 1, Insula: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||0.19|-0.41|0.3925
72479069|NCT02318797|144484380|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||Treatment by time interaction test||||<0.0001
72479070|NCT02318797|144484380|SUPERIORITY|||||||0.0019|||||||Mixed Models Analysis|||Test for gender by treatment by time interaction||||0.0019
72479071|NCT02318797|144484381|SUPERIORITY|||||||0.4103|||||||Mixed Models Analysis|||Treatment by time interaction test||||0.4103
72400151|NCT01082965|144308086|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.161||0.1991|TWO_SIDED|95.0|-0.58|0.14||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 0 on Day 8, Insula: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||0.14|-0.58|0.1991
72400152|NCT01082965|144308086|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.151||0.5176|TWO_SIDED|95.0|-0.45|0.24||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 4 on Day 8, Insula: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||0.24|-0.45|0.5176
72400153|NCT01082965|144308086|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.143||0.314|TWO_SIDED|95.0|-0.5|0.18||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 4 on Day 1, Precuneus: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||0.18|-0.50|0.3140
72400154|NCT01082965|144308086|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.171||0.6348|TWO_SIDED|95.0|-0.46|0.29||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 0 on Day 8, Precuneus: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||0.29|-0.46|0.6348
72400155|NCT01082965|144308086|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.26|STANDARD_ERROR_OF_MEAN|0.165||0.1491|TWO_SIDED|95.0|-0.64|0.12||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 4 on Day 8, Precuneus: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||0.12|-0.64|0.1491
72400156|NCT01082965|144308086|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.192||0.4226|TWO_SIDED|95.0|-0.59|0.27||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 4 on Day 1, Anterior Cingulate Cortex: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||0.27|-0.59|0.4226
72400157|NCT01082965|144308086|SUPERIORITY_OR_OTHER||LS Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.228||0.9778|TWO_SIDED|95.0|-0.49|0.5||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 0 on Day 8, Anterior Cingulate Cortex: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||0.50|-0.49|0.9778
72479072|NCT02318797|144484381|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||Test for change over time from baseline (only conducted if treatment by time interaction test non-significant)||||<0.0001
72479073|NCT02318797|144484381|SUPERIORITY|||||||0.4068|||||||Mixed Models Analysis|||Test for gender by treatment by time interaction||||0.4068
72479074|NCT02318797|144484381|SUPERIORITY|||||||0.2656|||||||Mixed Models Analysis|||Test for gender by treatment interaction (only calculated if gender by treatment by time non-significant)||||0.2656
72400158|NCT01082965|144308086|SUPERIORITY_OR_OTHER||LS Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.179||0.9456|TWO_SIDED|95.0|-0.4|0.43||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 4 on Day 8, Anterior Cingulate Cortex: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||0.43|-0.40|0.9456
72479075|NCT02318797|144484382|SUPERIORITY|||||||0.4582|||||||Mixed Models Analysis|||Treatment by time interaction test||||0.4582
72400159|NCT01082965|144308086|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.162||0.2299|TWO_SIDED|95.0|-0.55|0.15||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 4 on Day 1, Amygdala: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||0.15|-0.55|0.2299
72400160|NCT01082965|144308086|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.188||0.5069|TWO_SIDED|95.0|-0.54|0.28||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 0 on Day 8, Amygdala: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||0.28|-0.54|0.5069
72479076|NCT02318797|144484382|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||Test for change over time from baseline (only conducted if treatment by time interaction test non-significant)||||<0.0001
72479077|NCT02318797|144484382|SUPERIORITY|||||||0.05|||||||Mixed Models Analysis|||Test for gender by treatment by time interaction||||0.05
72479078|NCT02318797|144484382|SUPERIORITY|||||||0.1792|||||||Mixed Models Analysis|||Test for gender by treatment interaction (only calculated if gender by treatment by time non-significant)||||0.1792
72479079|NCT02318797|144484383|SUPERIORITY|||||||0.2179|||||||Mixed Models Analysis|||Treatment by time interaction test||||0.2179
72479080|NCT02318797|144484383|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||Test for change over time from baseline (only conducted if treatment by time interaction test non-significant)||||<0.0001
72400161|NCT01082965|144308086|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.143||0.3524|TWO_SIDED|95.0|-0.45|0.17||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 4 on Day 8, Amygdala: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||0.17|-0.45|0.3524
72479081|NCT02318797|144484383|SUPERIORITY|||||||0.4797|||||||Mixed Models Analysis|||Test for gender by treatment by time interaction||||0.4797
72479082|NCT02318797|144484383|SUPERIORITY|||||||0.0014|||||||Mixed Models Analysis|||Test for gender by treatment interaction (only calculated if gender by treatment by time non-significant)||||0.0014
72479083|NCT02318797|144484384|SUPERIORITY|||||||0.0058|||||||Mixed Models Analysis|||Treatment by time interaction test||||0.0058
72479084|NCT02318797|144484385|SUPERIORITY|||||||0.0014|||||||Mixed Models Analysis|||Treatment by time interaction test||||0.0014
72479085|NCT02318797|144484386|SUPERIORITY|||||||0.0001|||||||Mixed Models Analysis|||Test for treatment by time interaction||||0.0001
72479086|NCT02318797|144484387|SUPERIORITY|||||||0.5566|||||||Mixed Models Analysis|||Treatment by time interaction test||||0.5566
72479087|NCT02318797|144484387|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||Test for change over time (only calculated if treatment by time interaction non-significant)||||<0.0001
72400162|NCT01082965|144308086|SUPERIORITY_OR_OTHER||LS Mean Difference|0.34|STANDARD_ERROR_OF_MEAN|0.358||0.4182|TWO_SIDED|95.0|-0.8|1.47||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 4 on Day 1, Thalamus: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||1.47|-0.80|0.4182
72400163|NCT01082965|144308086|SUPERIORITY_OR_OTHER||LS Mean Difference|0.31|STANDARD_DEVIATION|0.326||0.363|TWO_SIDED|95.0|-0.42|1.04||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 0 on Day 8, Thalamus: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||1.04|-0.42|0.3630
72400164|NCT01082965|144308086|SUPERIORITY_OR_OTHER||LS Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.263||0.9837|TWO_SIDED|95.0|-0.73|0.74||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 4 on Day 8, Thalamus: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||0.74|-0.73|0.9837
72400165|NCT01082965|144308086|SUPERIORITY_OR_OTHER||LS Mean Difference|0.19|STANDARD_ERROR_OF_MEAN|0.102||0.0974|TWO_SIDED|95.0|-0.04|0.42||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 4 on Day 1, Basal Ganglia: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||0.42|-0.04|0.0974
72400166|NCT01082965|144308086|SUPERIORITY_OR_OTHER||LS Mean Difference|0.11|STANDARD_ERROR_OF_MEAN|0.067||0.1246|TWO_SIDED|95.0|-0.04|0.27||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 0 on Day 8, Basal Ganglia: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||0.27|-0.04|0.1246
72400167|NCT01082965|144308086|SUPERIORITY_OR_OTHER||LS Mean Difference|0.06|STANDARD_ERROR_OF_MEAN|0.119||0.619|TWO_SIDED|95.0|-0.2|0.32||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 4 on Day 8, Basal Ganglia: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||0.32|-0.20|0.6190
72400168|NCT01082965|144308086|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.14||0.635|TWO_SIDED|95.0|-0.39|0.25||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 4 on Day 1, Hippocampus: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||0.25|-0.39|0.6350
72479088|NCT02318797|144484388|SUPERIORITY|||||||0.002|||||||Mixed Models Analysis|||Test for treatment by time interaction||||0.002
72479089|NCT02318797|144484389|SUPERIORITY|||||||0.0029|||||||Mixed Models Analysis|||Test for treatment by time interaction||||0.0029
72479090|NCT02318797|144484390|SUPERIORITY|||||||0.0021|||||||Mixed Models Analysis|||Test for treatment by time interaction||||0.0021
72479091|NCT02318797|144484391|SUPERIORITY|||||||0.1183|||||||Mixed Models Analysis|||Test for treatment by time interaction||||0.1183
72479092|NCT02318797|144484391|SUPERIORITY|||||||0.0569|||||||Mixed Models Analysis|||Test for change over time (only calculated if treatment by time interaction non-significant)||||0.0569
72479093|NCT02318797|144484392|SUPERIORITY|||||||0.0745|||||||Mixed Models Analysis|||Test for treatment by time interaction||||0.0745
72400169|NCT01082965|144308086|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.164||0.8205|TWO_SIDED|95.0|-0.4|0.32||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 0 on Day 8, Hippocampus: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||0.32|-0.40|0.8205
72479094|NCT02318797|144484392|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||Test for change over time (only calculated if treatment by time interaction non-significant)||||<0.0001
72479095|NCT02318797|144484393|SUPERIORITY|||||||0.1653|||||||Mixed Models Analysis|||Test for treatment by time interaction||||0.1653
72479096|NCT02318797|144484393|SUPERIORITY|||||||0.1772|||||||Mixed Models Analysis|||Test for change over time (only calculated if treatment by time interaction non-significant)||||0.1772
72479097|NCT02318797|144484394|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||Test for treatment by time interaction||||<0.0001
72479098|NCT02318797|144484395|SUPERIORITY|||||||0.0202|||||||Mixed Models Analysis|||Test for treatment by time interaction||||0.0202
72400170|NCT01082965|144308086|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.123||0.2959|TWO_SIDED|95.0|-0.42|0.14||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 4 on Day 8, Hippocampus: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||0.14|-0.42|0.2959
72400171|NCT01082965|144308086|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.194||0.552|TWO_SIDED|95.0|-0.56|0.32||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 4 on Day 1, Landau: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||0.32|-0.56|0.5520
72479099|NCT02318797|144484396|SUPERIORITY|||||||0.4715|||||||Mixed Models Analysis|||Test for treatment by time interaction||||0.4715
72479100|NCT02318797|144484396|SUPERIORITY|||||||0.9209|||||||Mixed Models Analysis|||Test for change over time (only calculated if treatment by time interaction non-significant)||||0.9209
72479101|NCT00704405|144484410|SUPERIORITY_OR_OTHER||Adjusted difference in percentage|53.6|||<|0.001|TWO_SIDED|95.0|34.5|69.1|||Miettinen and Nurminen method||Adjusted difference subtracts the percentage of PBO-treated participants (i.e., 19.0%) that achieved SVR24 and stratifies by prior treatment response.|||69.1|34.5|<0.001
72479102|NCT00704405|144484410|SUPERIORITY_OR_OTHER||Adjusted difference in percentage|64.4|||<|0.001|TWO_SIDED|95.0|45.2|78.3|||Miettinen and Nurminen method||Adjusted difference subtracts the percentage of PBO-treated participants (i.e., 19.0%) that achieved SVR24 and stratifies by prior treatment response.|||78.3|45.2|<0.001
72479103|NCT00704405|144484410|SUPERIORITY_OR_OTHER||Adjusted difference in percentage|59.0|||<|0.001|TWO_SIDED|95.0|40.2|73.4|||Miettinen and Nurminen||Adjusted difference subtracts the percentage of PBO-treated participants (i.e., 19.0%) that achieved SVR24 and stratifies by prior treatment response.|||73.4|40.2|<0.001
72576841|NCT00261443|144680660|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.37||||0.027|TWO_SIDED|95.0|-0.7|-0.04||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 40 Comparison||-0.04|-0.70|0.027
72400172|NCT01082965|144308086|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.22||0.9046|TWO_SIDED|95.0|-0.5|0.45||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 0 on Day 8, Landau: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||0.45|-0.50|0.9046
72479104|NCT00704405|144484413|SUPERIORITY_OR_OTHER||Adjusted difference in percentage|47.3|||<|0.001|TWO_SIDED|95.0|29.2|63.2|||Miettinen and Nurminen||Adjusted difference subtracts the percentage of PBO-treated participants (i.e., 19.0%) that achieved SVR24 and stratifies by prior treatment response.|||63.2|29.2|<0.001
72479105|NCT00704405|144484414|SUPERIORITY_OR_OTHER||Adjusted difference in percentage|82.6|||||TWO_SIDED|95.0|69.5|90.2|||||Adjusted difference subtracts the percentage of PBO-treated participants (i.e., 9.5%) that achieved cEVR and stratifies by prior treatment response.|||90.2|69.5|
72479106|NCT00704405|144484414|SUPERIORITY_OR_OTHER||Adjusted difference in percentage|76.1|||||TWO_SIDED|95.0|60.1|86.7|||||Adjusted difference subtracts the percentage of PBO-treated participants (i.e., 9.5%) that achieved cEVR and stratifies by prior treatment response.|||86.7|60.1|
72479107|NCT00704405|144484415|SUPERIORITY_OR_OTHER||Adjusted difference in percentage|35.8|||||TWO_SIDED|95.0|15.5|53.4|||Miettinen and Nurminen method||Adjusted difference subtracts the percentage of PBO patients (36.6%) with undetectable HCV RNA at Week 48 and stratifies by prior treatment response.|||53.4|15.5|
72479108|NCT01395888|144484416|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.259||||0.484|TWO_SIDED|95.0|-0.468|0.986|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM)||||0.986|-0.468|0.484
72479109|NCT03218397|144484417|SUPERIORITY||Difference in means|5.6||||0.013|TWO_SIDED|95.0|1.2|10.0||alpha = 0.05|t-test, 2 sided||Difference in mean hours to first antibiotic modification (Standard Blood Culture and AST minus Rapid Organism Identification and AST)|||10|1.2|0.013
72479110|NCT03218397|144484418|SUPERIORITY|||||||0.265||||||alpha = 0.05|Fisher Exact|||||||0.265
72479111|NCT03218397|144484419|SUPERIORITY|||||||0.093||||||alpha = 0.05|t-test, 2 sided|T-test for the difference in mean length of stay (days) between treatment arms among subjects alive at 30 days.||||||0.093
72479112|NCT03218397|144484420|SUPERIORITY|||||||0.014||||||alpha = 0.05|Fisher Exact|||||||0.014
72479113|NCT03218397|144484421|SUPERIORITY||Difference in means|7.5||||0.009|TWO_SIDED|95.0|1.9|13.1||alpha = 0.05|t-test, 2 sided||Difference in mean hours to first antibiotic escalation (Standard Blood Culture and AST minus Rapid Organism Identification and AST)|||13.1|1.9|0.009
72479114|NCT03218397|144484422|SUPERIORITY||Difference in means|6.5||||0.022|TWO_SIDED|95.0|0.9|12.0||alpha = 0.05|t-test, 2 sided||Difference in mean hours to first gram-negative antibiotic escalation (Standard Blood Culture and AST minus Rapid Organism Identification and AST)|||12.0|0.9|0.022
72479115|NCT03218397|144484423|SUPERIORITY||Difference in means|0.7||||0.46|TWO_SIDED|95.0|-1.2|2.7||alpha = 0.05|t-test, 2 sided||Difference in mean hours to first gram-positive antibiotic escalation (Standard Blood Culture and AST minus Rapid Organism Identification and AST)|||2.7|-1.2|0.46
72479116|NCT03218397|144484424|SUPERIORITY||Difference in means|4.6||||0.074|TWO_SIDED|95.0|-0.4|9.6||alpha = 0.05|t-test, 2 sided||Difference in mean hours to first antibiotic de-escalation (Standard Blood Culture and AST minus Rapid Organism Identification and AST)|||9.6|-0.4|0.074
72479117|NCT03218397|144484425|SUPERIORITY||Difference in means|6.5||||0.008|TWO_SIDED|95.0|1.7|11.2||alpha = 0.05|t-test, 2 sided||Difference in mean hours to first gram-negative antibiotic de-escalation (Standard Blood Culture and AST minus Rapid Organism Identification and AST)|||11.2|1.7|0.008
72479118|NCT03218397|144484426|SUPERIORITY||Difference in means|-1.9||||0.37|TWO_SIDED|95.0|-5.9|2.2||alpha = 0.05|t-test, 2 sided||Difference in mean hours to first gram-positive antibiotic de-escalation (Standard Blood Culture and AST minus Rapid Organism Identification and AST)|||2.2|-5.9|0.37
72479119|NCT00409773|144484497|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-13.1|STANDARD_ERROR_OF_MEAN|1.7|<|0.001||95.0|-16.5|-9.8||Reported p-value is multiplicity-adjusted. Hochberg procedure was used to adjust for multiple comparisons.|ANOVA|ANOVA with terms for treatment and baseline risk stratum||||-9.8|-16.5|<0.001
72479120|NCT00409773|144484497|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-10.2|STANDARD_ERROR_OF_MEAN|1.7|<|0.001||95.0|-13.6|-6.9||Reported p-value is multiplicity-adjusted. Hochberg procedure was used to adjust for multiple comparisons.|ANOVA|ANOVA with terms for treatment and baseline risk stratum||||-6.9|-13.6|<0.001
72479121|NCT00409773|144484497|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-8.0|STANDARD_ERROR_OF_MEAN|1.7|<|0.001||95.0|-11.3|-4.6||Reported p-value is multiplicity-adjusted. Hochberg procedure was used to adjust for multiple comparisons.|ANOVA|ANOVA with terms for treatment and baseline risk stratum||||-4.6|-11.3|<0.001
72479122|NCT00409773|144484498|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-7.2|STANDARD_ERROR_OF_MEAN|1.2|<|0.001||95.0|-9.6|-4.8|||ANOVA|ANOVA with terms for treatment and baseline risk stratum||||-4.8|-9.6|<0.001
72479123|NCT00409773|144484498|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.4|STANDARD_ERROR_OF_MEAN|1.2|<|0.001||95.0|-7.8|-2.9|||ANOVA|ANOVA with terms for treatment and baseline risk stratum||||-2.9|-7.8|<0.001
72623602|NCT04938427|144778027|SUPERIORITY||Hodges-Lehmann Location Shift Estimate|2.43|||=|0.778|TWO_SIDED|95.0|-10.86|15.14||The p-value was calculated using the Rank ANCOVA model using the treatment group, age stratum (≤6 years, \>6 years), and rank of Baseline seizure frequency per 28 days as predictors.|ANCOVA||The location shift between soticlestat and placebo (soticlestat - placebo) and its asymptotic 95% CI are based on the Hodges-Lehmann estimation.|||15.14|-10.86|=0.778
72623603|NCT04938427|144778028|SUPERIORITY||Odds Ratio (OR)|1.91|||||TWO_SIDED|95.0|0.94|3.87||||||||3.87|0.94|
72400173|NCT01082965|144308086|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.32|STANDARD_ERROR_OF_MEAN|0.125||0.0402|TWO_SIDED|95.0|-0.62|-0.02||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 4 on Day 8, Landau: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||-0.02|-0.62|0.0402
72400174|NCT01082965|144308087|SUPERIORITY_OR_OTHER||LS Mean Difference|5.0|STANDARD_ERROR_OF_MEAN|12.11||0.688|TWO_SIDED|95.0|-21.82|31.82||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 5 on Day 1: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||31.82|-21.82|0.6880
72400175|NCT01082965|144308087|SUPERIORITY_OR_OTHER||LS Mean Difference|9.79|STANDARD_ERROR_OF_MEAN|9.143||0.3157|TWO_SIDED|95.0|-11.3|30.87||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 0 on Day 8: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||30.87|-11.30|0.3157
72400176|NCT01082965|144308087|SUPERIORITY_OR_OTHER||LS Mean Difference|9.86|STANDARD_ERROR_OF_MEAN|8.921||0.3228|TWO_SIDED|95.0|-13.56|33.28||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 5 on Day 8: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||33.28|-13.56|0.3228
72479124|NCT00409773|144484498|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.4|STANDARD_ERROR_OF_MEAN|1.2|<|0.001||95.0|-6.8|-2.0|||ANOVA|ANOVA with terms for treatment and baseline risk stratum||||-2.0|-6.8|<0.001
72479125|NCT00409773|144484499|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.9||||0.69||95.0|-5.4|3.3|||Non-parametric ANOVA|ANOVA using normal scores (Tukey method) based on ranks with terms for treatment and baseline risk stratum||||3.3|-5.4|0.690
72479126|NCT00409773|144484499|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|2.8||||0.2||95.0|-1.6|7.1|||Non-parametric ANOVA|ANOVA using normal scores (Tukey method) based on ranks with terms for treatment and baseline risk stratum||||7.1|-1.6|0.200
72479127|NCT00409773|144484499|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-0.4||||0.48||95.0|-4.7|3.9|||Non-parametric ANOVA|ANOVA using normal scores (Tukey method) based on ranks with terms for treatment and baseline risk stratum||||3.9|-4.7|0.480
72479128|NCT00409773|144484500|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.4|STANDARD_ERROR_OF_MEAN|1.3||0.013||95.0|0.7|6.0|||ANOVA|ANOVA with terms for treatment and baseline risk stratum||||6.0|0.7|0.013
72479129|NCT00409773|144484500|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.2|STANDARD_ERROR_OF_MEAN|1.3||0.378||95.0|-1.5|3.8|||ANOVA|ANOVA with terms for treatment and baseline risk stratum||||3.8|-1.5|0.378
72479130|NCT00409773|144484500|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.0|STANDARD_ERROR_OF_MEAN|1.3||0.003||95.0|1.3|6.6|||ANOVA|ANOVA with terms for treatment and baseline risk stratum||||6.6|1.3|0.003
72479131|NCT00409773|144484501|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-10.3|STANDARD_ERROR_OF_MEAN|1.5|<|0.001||95.0|-13.3|-7.3|||ANOVA|ANOVA with terms for treatment and baseline risk stratum||||-7.3|-13.3|<0.001
72479132|NCT00409773|144484501|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-7.3|STANDARD_ERROR_OF_MEAN|1.5|<|0.001||95.0|-10.2|-4.3|||ANOVA|ANOVA with terms for treatment and baseline risk stratum||||-4.3|-10.2|<0.001
72479133|NCT00409773|144484501|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.9|STANDARD_ERROR_OF_MEAN|1.5|<|0.001||95.0|-9.9|-3.9|||ANOVA|ANOVA with terms for treatment and baseline risk stratum||||-3.9|-9.9|<0.001
72479134|NCT00409773|144484502|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|2.6||0.809||95.0|-5.7|4.5|||ANOVA|ANOVA with terms for treatment and baseline risk stratum||||4.5|-5.7|0.809
72509242|NCT04598165|144548751|SUPERIORITY||Risk Ratio (RR)|1.25||||0.314|TWO_SIDED|95.0|0.81|1.92||The primary intention to treat analysis was adjusted for differences in exposure to other SMS programs and phone ownership. The threshold for statistical significance was p=0.05.|Poisson regression||SMS group is the numerator|We estimated a sample size of 5000 to detect a risk ratio of ≤0.53 assuming a neonatal mortality rate of 23 per 1000 in the control arm with 80% power and, 95% confidence and taking into account a 10% attrition. Multiple imputation with chain equations (MICE) was used to impute missing values for any outcome with greater than 10% missingness. Any variables associated with the outcome or outcome missingness were included in the imputation model.||1.92|0.81|0.314
72509243|NCT04598165|144548752|SUPERIORITY||Risk Ratio (RR)|1.36||||0.217|TWO_SIDED|95.0|0.84|2.21||The intention to treat analysis was adjusted for differences in exposure to other SMS programs and phone ownership. We corrected for multiple comparisons using the Benjamini-Hochberg method. The threshold for statistical significance was p=0.05.|Poisson regression||SMS group is the numerator|We estimated a sample size of 5000 to detect a risk ratio of ≤0.53 assuming a neonatal mortality rate of 23 per 1000 in the control arm with 80% power and, 95% confidence and taking into account a 10% attrition. Multiple imputation with chain equations (MICE) was used to impute missing values for any outcome with greater than 10% missingness. Any variables associated with the outcome or outcome missingness were included in the imputation model.||2.21|0.84|0.217
72509244|NCT04598165|144548753|SUPERIORITY||Risk Ratio (RR)|1.04||||0.064|TWO_SIDED|95.0|1.0|1.08||The intention to treat analysis was adjusted for differences in exposure to other SMS programs and phone ownership. We corrected for multiple comparisons using the Benjamini-Hochberg method. The threshold for statistical significance was p=0.05.|Poisson regression||SMS group is the numerator|We estimated a sample size of 5000 to detect a risk ratio of ≤0.53 assuming a neonatal mortality rate of 23 per 1000 in the control arm with 80% power and, 95% confidence and assuming 10% attrition. With this sample size, assuming alpha=0.0045 (Bonferroni adjusted for 11 tests), we also had 80% power to detect a risk ratio of 1.05 in early initiation of breast feeding assuming 80% uptake in controls.||1.08|1.00|0.064
72479135|NCT00409773|144484502|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.2|STANDARD_ERROR_OF_MEAN|2.6||0.217||95.0|-1.9|8.4|||ANOVA|ANOVA with terms for treatment and baseline risk stratum||||8.4|-1.9|0.217
72479136|NCT00409773|144484502|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|2.6||0.796||95.0|-5.8|4.4|||ANOVA|ANOVA with terms for treatment and baseline risk stratum||||4.4|-5.8|0.796
72479137|NCT00409773|144484503|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-9.4|STANDARD_ERROR_OF_MEAN|1.4|<|0.001||95.0|-12.1|-6.6|||ANOVA|ANOVA with terms for treatment and baseline risk stratum||||-6.6|-12.1|<0.001
72479138|NCT00409773|144484503|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.3|STANDARD_ERROR_OF_MEAN|1.4|<|0.001||95.0|-8.1|-2.6|||ANOVA|ANOVA with terms for treatment and baseline risk stratum||||-2.6|-8.1|<0.001
72479139|NCT00409773|144484503|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.3|STANDARD_ERROR_OF_MEAN|1.4|<|0.001||95.0|-8.0|-2.5|||ANOVA|ANOVA with terms for treatment and baseline risk stratum||||-2.5|-8.0|<0.001
72479140|NCT00409773|144484504|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.4|STANDARD_ERROR_OF_MEAN|1.2||0.042||95.0|0.1|4.8|||ANOVA|ANOVA with terms for treatment and baseline risk stratum||||4.8|0.1|0.042
72479141|NCT00409773|144484504|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.2|STANDARD_ERROR_OF_MEAN|1.2|<|0.001||95.0|-0.2|4.5|||ANOVA|ANOVA with terms for treatment and baseline risk stratum||||4.5|-0.2|<0.001
72479142|NCT00409773|144484504|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.6|STANDARD_ERROR_OF_MEAN|1.2|<|0.001||95.0|-7.0|4.0|||ANOVA|ANOVA with terms for treatment and baseline risk stratum||||4.0|-7.0|<0.001
72479143|NCT00409773|144484505|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-8.8|STANDARD_ERROR_OF_MEAN|1.4|<|0.001||95.0|-11.6|-6.0|||ANOVA|ANOVA with terms for treatment and baseline risk stratum||||-6.0|-11.6|<0.001
72479144|NCT00409773|144484505|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.3|STANDARD_ERROR_OF_MEAN|1.4|<|0.001||95.0|-8.2|-2.5|||ANOVA|ANOVA with terms for treatment and baseline risk stratum||||-2.5|-8.2|<0.001
72479145|NCT00409773|144484505|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.9|STANDARD_ERROR_OF_MEAN|1.4|<|0.001||95.0|-8.7|-3.1|||ANOVA|ANOVA with terms for treatment and baseline risk stratum||||-3.1|-8.7|<0.001
72479146|NCT00409773|144484506|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-14.0|STANDARD_ERROR_OF_MEAN|1.8|<|0.001||95.0|-17.6|-10.5|||ANOVA|ANOVA with terms for treatment and baseline risk stratum||||-10.5|-17.6|<0.001
72479147|NCT00409773|144484506|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-9.7|STANDARD_ERROR_OF_MEAN|1.8|<|0.001||95.0|-13.2|-6.1|||ANOVA|ANOVA with terms for treatment and baseline risk stratum||||-6.1|-13.2|<0.001
72479148|NCT00409773|144484506|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-8.5|STANDARD_ERROR_OF_MEAN|1.8|<|0.001||95.0|-12.0|-4.9|||ANOVA|ANOVA with terms for treatment and baseline risk stratum||||-4.9|-12.0|<0.001
72479149|NCT00409773|144484507|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-11.0|STANDARD_ERROR_OF_MEAN|1.5|<|0.001||95.0|-14.0|-8.0|||ANOVA|ANOVA with terms for treatment and baseline risk stratum||||-8.0|-14.0|<0.001
72623604|NCT04938427|144778029|SUPERIORITY||Odds Ratio (OR)|1.93|||||TWO_SIDED|95.0|0.92|4.05||||||||4.05|0.92|
72479150|NCT00409773|144484507|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.4|STANDARD_ERROR_OF_MEAN|1.5|<|0.001||95.0|-9.4|-3.3|||ANOVA|ANOVA with terms for treatment and baseline risk stratum||||-3.3|-9.4|<0.001
72479151|NCT00409773|144484507|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.7|STANDARD_ERROR_OF_MEAN|1.5|<|0.001||95.0|-8.7|-2.7|||ANOVA|ANOVA with terms for treatment and baseline risk stratum||||-2.7|-8.7|<0.001
72479152|NCT00409773|144484508|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-11.5|STANDARD_ERROR_OF_MEAN|1.8|<|0.001||95.0|-15.0|-8.1|||ANOVA|ANOVA with terms for treatment and baseline risk stratum||||-8.1|-15.0|<0.001
72479153|NCT00409773|144484508|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-7.0|STANDARD_ERROR_OF_MEAN|1.8|<|0.001||95.0|-10.4|-3.6|||ANOVA|ANOVA with terms for treatment and baseline risk stratum||||-3.6|-10.4|<0.001
72479154|NCT00409773|144484508|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-7.7|STANDARD_ERROR_OF_MEAN|1.8|<|0.001||95.0|-11.2|-4.3|||ANOVA|ANOVA with terms for treatment and baseline risk stratum||||-4.3|-11.2|<0.001
72479155|NCT00409773|144484511|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-2.9||||0.42||95.0|-11.0|5.0|||Non-parametric ANOVA|ANOVA using normal scores (Tukey method) based on ranks with terms for treatment and baseline risk stratum||||5.0|-11.0|0.420
72479156|NCT00409773|144484511|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-0.9||||0.555||95.0|-9.5|7.2|||Non-parametric ANOVA|ANOVA using normal scores (Tukey method) based on ranks with terms for treatment and baseline risk stratum||||7.2|-9.5|0.555
72479157|NCT00409773|144484511|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|2.3||||0.41||95.0|-5.1|9.6|||Non-parametric ANOVA|ANOVA using normal scores (Tukey method) based on ranks with terms for treatment and baseline risk stratum||||9.6|-5.1|0.410
72479158|NCT01919814|144484518|SUPERIORITY||||||>|0.05||||||Threshold P-Value was 0.05|t-test, 2 sided|||||||>0.05
72479159|NCT02164383|144484521|SUPERIORITY||Mean Difference (Final Values)|1.82||||0.85|TWO_SIDED||||||ANOVA||ANOVA results: F(1,28)=.04, p=.85, partial eta-squared (as a measure of effect size) = .001|||||.85
72479160|NCT02831387|144484524|SUPERIORITY||Mean Difference (Net)|-1.88||||0.749|TWO_SIDED|95.0|-13.696|9.936|||Mixed Models Analysis|||Statistical Analysis 1 for Change From Baseline to Day 29 in the Subject Reported Dry Eye Questionnaire||9.936|-13.696|0.749
72479161|NCT02831387|144484525|SUPERIORITY||Mean Difference (Net)|-6.6||||0.267|TWO_SIDED|95.0|-18.4|5.3|||Mixed Models Analysis|||Statistical Analysis 1 for Change From Baseline (Visit 2) to Day 29 in Frequency Scores||5.3|-18.4|0.267
72542456|NCT00106028|144614675|SUPERIORITY_OR_OTHER||Mean Difference (Net)|5.494||||0.003||95.0|1.912|9.077|||ANCOVA|LS means and p-value are from ANCOVA model adjusted by baseline and fixed effects for age group, treatment and pooled center for post-baseline.||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.||9.077|1.912|0.0030
72400177|NCT01082965|144308088|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.39|STANDARD_ERROR_OF_MEAN|3.479||0.254|TWO_SIDED|95.0|-12.9|4.12||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Total IR: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||4.12|-12.90|0.2540
72400178|NCT01082965|144308088|SUPERIORITY_OR_OTHER||LS Mean Difference|0.6|STANDARD_ERROR_OF_MEAN|1.95||0.7684|TWO_SIDED|95.0|-4.17|5.37||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Total DR: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||5.37|-4.17|0.7684
72400179|NCT01082965|144308089|SUPERIORITY_OR_OTHER||LS Mean Difference|0.04|STANDARD_ERROR_OF_MEAN|0.059||0.494|TWO_SIDED|95.0|-0.09|0.17||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 5 on Day 1, Detection Task: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||0.17|-0.09|0.4940
72400180|NCT01082965|144308089|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.057||0.1031|TWO_SIDED|95.0|-0.02|0.22||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 0 on Day 8, Detection Task: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||0.22|-0.02|0.1031
72400181|NCT01082965|144308089|SUPERIORITY_OR_OTHER||LS Mean Difference|0.05|STANDARD_ERROR_OF_MEAN|0.048||0.3277|TWO_SIDED|95.0|-0.06|0.16||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 5 on Day 8, Detection Task: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||0.16|-0.06|0.3277
72400182|NCT01082965|144308089|SUPERIORITY_OR_OTHER||LS Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.029||0.6585|TWO_SIDED|95.0|-0.05|0.08||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 5 on Day 1, Identification Task: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||0.08|-0.05|0.6585
72400183|NCT01082965|144308089|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.033||0.8863|TWO_SIDED|95.0|-0.07|0.08||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 0 on Day 8, Identification Task: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||0.08|-0.07|0.8863
72400184|NCT01082965|144308089|SUPERIORITY_OR_OTHER||LS Mean Difference|0.04|STANDARD_ERROR_OF_MEAN|0.044||0.4388|TWO_SIDED|95.0|-0.06|0.13||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 5 on Day 8, Identification Task: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||0.13|-0.06|0.4388
72400185|NCT02587065|144308090|OTHER||Spearman's correlation coefficient|-0.85||||0.56|TWO_SIDED|95.0|-3.72|2.02|||Mixed-effects REML regression|||Adjusted change of convenience satisfaction domain of TSQM-9.||2.02|-3.72|0.56
72566552|NCT02409329|144663370|SUPERIORITY|Testing superiority of REACH\_FAMS relative to control. We used ordinary least squares linear regression with Huber-White heteroscedasticity-consistent standard errors to obtain point estimates and 95% CIs for the intervention effect at each time.|Predicted mean difference|-0.65|||||TWO_SIDED|95.0|-1.26|-0.05|||||6-month point estimate|To evaluate if REACH only and REACH+FAMS had similar effects on HbA1c relative to control, we subsetted to participants with baseline HbA1c greater than or equal to 8.5% to maximize our power for these analyses. We used generalized estimating equations (GEE) with a working-exchangeable correlation structure and identity link, adjusting for baseline and allowing a time-treatment interaction. Multiply imputed data (m=1,000) using chained equations.||-0.05|-1.26|
72400186|NCT04035161|144308104|NON_INFERIORITY|A non-inferiority criterion with a 0.5 log10 margin will be implemented for the average treatment effect (ATE) of the Investigational Product compared to the Active Control (i.e., the upper two-sided 95% confidence bound of the post-product application bacterial load corrected for pre-product application bacterial load of the Investigational Product - Active Control should be less than 0.5 log10).|Mean Difference (Final Values)|0.01|||||TWO_SIDED|95.0|-0.15|0.16||||||"Abdomen at 10 minutes post-product application.~Average treatment effect (ATE) of the Investigational Product compared to the Active Control on the abdomen at 10 minutes post-product application. ATE was calculated using a linear regression model for each body site used for primary analysis. In the model, the response was the post-treatment log10 bacterial counts and predictors were the treatment effect as a fixed effect and the pre-treatment log10 bacterial counts as a covariate."||0.16|-0.15|
72400187|NCT04035161|144308104|NON_INFERIORITY|A non-inferiority criterion with a 0.5 log10 margin will be implemented for the average treatment effect (ATE) of the Investigational Product compared to the Active Control (i.e., the upper two-sided 95% confidence bound of the post-product application bacterial load corrected for pre-product application bacterial load of the Investigational Product - Active Control should be less than 0.5 log10).|Mean Difference (Final Values)|-0.24|||||TWO_SIDED|95.0|-0.43|-0.05||||||"Groin at 10 minutes post-product application.~Average treatment effect (ATE) of the Investigational Product compared to the Active Control on the groin at 10 minutes post-product application. ATE was calculated using a linear regression model for each body site used for primary analysis. In the model, the response was the post-treatment log10 bacterial counts and predictors were the treatment effect as a fixed effect and the pre-treatment log10 bacterial counts as a covariate."||-0.05|-0.43|
72400188|NCT04035161|144308104|SUPERIORITY||Mean Difference (Final Values)|1.82|||||TWO_SIDED|95.0|1.66|1.97||||||"Abdomen at 10 minutes post-product application.~Average treatment effect (ATE) of the Investigational Product compared to the Negative Control on the abdomen at 10 minutes post-product application. ATE was calculated using a linear regression model for each body site used for primary analysis. In the model, the response was the post-treatment log10 bacterial counts and predictors were the treatment effect as a fixed effect and the pre-treatment log10 bacterial counts as a covariate."||1.97|1.66|
72576842|NCT00261443|144680660|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.37||||0.029|TWO_SIDED|95.0|-0.71|-0.04||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 44 Comparison||-0.04|-0.71|0.029
72479162|NCT02831387|144484526|SUPERIORITY||Mean Difference (Net)|3.9||||0.495|TWO_SIDED|95.0|-7.6|15.4|||Mixed Models Analysis|||Statistical Analysis 1 for Change From Baseline (Visit 2) to Day 29 in Severity Scores||15.4|-7.6|0.495
72479163|NCT02831387|144484527|SUPERIORITY||Mean Difference (Net)|0.6||||0.316|TWO_SIDED|95.0|-0.6|1.9|||Mixed Models Analysis|||Statistical Analysis 1 for Change From Baseline to Day 29 in Fluorescein Staining of the Cornea||1.9|-0.6|0.316
72479164|NCT02831387|144484528|SUPERIORITY||Mean Difference (Net)|-0.2||||0.823|TWO_SIDED|95.0|-1.9|1.5|||Mixed Models Analysis|||Statistical Analysis 1 for Change From Baseline to Day 29 in Lissamine Green Staining of the Conjunctiva||1.5|-1.9|0.823
72479165|NCT02831387|144484529|SUPERIORITY||Odds Ratio (OR)|1.923|||||TWO_SIDED|95.0|0.515|7.184||||||Statistical Analysis 1 for the Number of participants with at least 20% improvement in symptoms from baseline to Day 29||7.184|0.515|
72479166|NCT02831387|144484530|SUPERIORITY||Mean Difference (Net)|1.666||||0.723|TWO_SIDED|95.0|-7.759|11.092|||Mixed Models Analysis|||Statistical Analysis 1 for Change From Baseline (Visit 2) to Day 15 (Visit 3) in the Subject-reported Dry Eye Symptom Score||11.092|-7.759|0.723
72479167|NCT00192647|144484531|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.16||||0.2893|TWO_SIDED|95.0|0.88|1.52|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by viral load and country||||1.52|0.88|0.2893
72479168|NCT00192647|144484532|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.22|||||TWO_SIDED|95.0|0.91|1.63||||||||1.63|0.91|
72479169|NCT00192647|144484533|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.68|||||TWO_SIDED|95.0|1.24|2.27||||||Week 4||2.27|1.24|
72479170|NCT00192647|144484533|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.64|||||TWO_SIDED|95.0|1.24|2.17||||||Week 8||2.17|1.24|
72566553|NCT02409329|144663370|SUPERIORITY|Testing superiority of REACH+FAMS relative to control. We used ordinary least squares linear regression with Huber-White heteroscedasticity-consistent standard errors to obtain point estimates and 95% CIs for the intervention effect at each time.|Predicted mean difference|-0.31|||||TWO_SIDED|95.0|-0.96|0.51|||||12-month point estimate|To evaluate if REACH only and REACH+FAMS had similar effects on HbA1c relative to control, we subsetted to participants with baseline HbA1c greater than or equal to 8.5% to maximize our power for these analyses. We used generalized estimating equations (GEE) with a working-exchangeable correlation structure and identity link, adjusting for baseline and allowing a time-treatment interaction. Multiply imputed data (m=1,000) using chained equations.||0.51|-0.96|
72566554|NCT03291041|144663371|SUPERIORITY|LS mean and p-value are from ANCOVA with treatment and time-zone-shift as main effects and baseline value as a covariate.|Mean Difference (Net)|34.75||||0.0354|TWO_SIDED||||||ANCOVA|||||||0.0354
72566555|NCT03291041|144663372|SUPERIORITY|LS mean and p-value are from ANCOVA with treatment and time-zone-shift as main effects and baseline value as a covariate.|Mean Difference (Net)|-0.63||||0.0168|TWO_SIDED||||||ANCOVA|||||||0.0168
72566556|NCT03291041|144663373|SUPERIORITY|LS mean and p-value are from ANCOVA with treatment and time-zone-shift as main effects and baseline value as a covariate.|Mean Difference (Net)|90.56||||0.0785|TWO_SIDED||||||ANCOVA|||||||0.0785
72623605|NCT04938427|144778031|SUPERIORITY||Odds Ratio (OR)|1.35|||||TWO_SIDED|95.0|0.86|2.13||||||||2.13|0.86|
72479171|NCT00192647|144484533|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.88|||||TWO_SIDED|95.0|1.4|2.53||||||Week 12||2.53|1.40|
72479172|NCT00192647|144484533|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.46|||||TWO_SIDED|95.0|1.08|1.98||||||Week 24||1.98|1.08|
72479173|NCT01828073|144484539|OTHER||Clopper-Pearson Confidence Interval (CI)|31.82|||||TWO_SIDED|90.0|16.0|51.5|||||With the small sample size, the CI estimate tend to be wide.|Point and 90% CI estimates of percentage of full term infants meeting the composite safety endpoint (grade 3/4 adverse event, adverse birth outcome, death)||51.50|16.00|
72479174|NCT01828073|144484539|OTHER||Clopper-Pearson Confidence Interval (CI)|50.0|||||TWO_SIDED|90.0|29.1|70.9|||||With the small sample size, the CI estimate tend to be wide.|Point and 90% CI estimates of percentage of full term infants meeting the composite safety endpoint (grade 3/4 adverse event, death)||70.90|29.10|
72479175|NCT01828073|144484543|OTHER|||||||0.747||||||The study was not powered to do the comparison. This was an exploratory analysis.|Wilcoxon (Mann-Whitney)|||To investigate the relationship between neonatal RAL elimination and UGT1A1 genotype in full term infants.||||0.747
72566557|NCT03291041|144663374|SUPERIORITY|LS mean and p-value are from ANCOVA with treatment and time-zone-shift as main effects and baseline value as a covariate.|Mean Difference (Net)|78.45||||0.0225|TWO_SIDED||||||ANCOVA|||||||0.0225
72566558|NCT03291041|144663375|SUPERIORITY|LS mean and p-value are from ANCOVA with treatment and time-zone-shift as main effects and baseline value as a covariate.|Mean Difference (Net)|0.95||||0.0198|TWO_SIDED||||||ANCOVA|||||||0.0198
72566559|NCT03291041|144663376|SUPERIORITY|LS mean and p-value are from ANCOVA with treatment and time-zone-shift as main effects and baseline value as a covariate.|Mean Difference (Net)|-26.55||||0.0347|TWO_SIDED||||||ANCOVA|||||||0.0347
72566560|NCT03291041|144663377|SUPERIORITY|LS mean and p-value are from ANCOVA with treatment and time-zone-shift as main effects and baseline value as a covariate.|Mean Difference (Net)|-56.44||||0.084|TWO_SIDED||||||ANCOVA|||||||0.0840
72623606|NCT04938427|144778032|SUPERIORITY||Odds Ratio (OR)|1.4|||||TWO_SIDED|95.0|0.89|2.21||||||||2.21|0.89|
72623607|NCT04938427|144778033|SUPERIORITY||Odds Ratio (OR)|1.4|||||TWO_SIDED|95.0|0.85|2.3||||||Alertness Domain||2.30|0.85|
72623608|NCT04938427|144778033|SUPERIORITY||Odds Ratio (OR)|1.5|||||TWO_SIDED|95.0|0.91|2.48||||||Communication Domain||2.48|0.91|
72479176|NCT01828073|144484543|OTHER|||||||0.341||||||The study was not powered to do the comparison. This was an exploratory analysis.|Wilcoxon (Mann-Whitney)|||To investigate the relationship between neonatal RAL elimination and UGT1A1 genotype in LBW infants.||||0.341
72479177|NCT01350336|144484546|NON_INFERIORITY|An upper 95% confidence limit of the difference between Year 2 compared to the first 12-month proportion is less than 20% will demonstrate that the proportions are not substantially worse during each of the subsequent evaluation periods.|Difference of proportions|-0.038|||||TWO_SIDED|95.0|-0.1251|0.0497||||||Comparison of Years 1 and 2||0.0497|-0.1251|
72479178|NCT01350336|144484546|NON_INFERIORITY|An upper 95% confidence limit of the difference between Year 3 compared to the first 12-month proportion is less than 20% will demonstrate that the proportions are not substantially worse during each of the subsequent evaluation periods.|Difference of proportions|-0.0325|||||TWO_SIDED|95.0|-0.1197|0.0565||||||Comparison of Years 1 and 3||0.0565|-0.1197|
72479179|NCT01350336|144484546|NON_INFERIORITY|An upper 95% confidence limit of the difference between Year 4 compared to the first 12-month proportion is less than 20% will demonstrate that the proportions are not substantially worse during each of the subsequent evaluation periods.|Difference of proportions|-0.0566|||||TWO_SIDED|95.0|-0.1444|0.0329||||||Comparison of Years 1 and 4||0.0329|-0.1444|
72479180|NCT01350336|144484546|NON_INFERIORITY|An upper 95% confidence limit of the difference between Year 5 compared to the first 12-month proportion is less than 20% will demonstrate that the proportions are not substantially worse during each of the subsequent evaluation periods.|Difference of proportions|-0.0765|||||TWO_SIDED|95.0|-0.1661|0.013||||||Comparison of Years 1 and 5||0.0130|-0.1661|
72479181|NCT02079610|144484558|SUPERIORITY||Mean Difference (Final Values)|10.0|STANDARD_DEVIATION|3.93|<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
72509245|NCT04598165|144548754|SUPERIORITY||Risk Ratio (RR)|0.99||||0.363|TWO_SIDED|95.0|0.98|1.01||The intention to treat analysis was adjusted for differences in exposure to other SMS programs and phone ownership. We corrected for multiple comparisons using the Benjamini-Hochberg method. The threshold for statistical significance was p=0.05.|Poisson regression||SMS group is the numerator|We estimated a sample size of 5000 to detect a risk ratio of ≤0.53 assuming a neonatal mortality rate of 23 per 1000 in the control arm with 80% power and, 95% confidence and assuming 10% attrition. With this sample size, assuming alpha=0.0045 (Bonferroni adjusted for 11 tests), we also had 80% power to detect a risk ratio of 1.05 in exclusive breast feeding assuming 80% uptake in controls.||1.01|0.98|0.363
72479182|NCT02079610|144484559|SUPERIORITY||Mean Difference (Final Values)|8.2|STANDARD_DEVIATION|5.2||0.03|TWO_SIDED||||||Mixed Models Analysis|||||||0.03
72509246|NCT04598165|144548755|SUPERIORITY||Risk Ratio (RR)|1.01||||0.093|TWO_SIDED|95.0|1.0|1.02||The intention to treat analysis was adjusted for differences in exposure to other SMS programs and phone ownership. We corrected for multiple comparisons using the Benjamini-Hochberg method. The threshold for statistical significance was p=0.05.|Poisson regression||SMS group is the numerator|We estimated a sample size of 5000 to detect a risk ratio of ≤0.53 assuming a neonatal mortality rate of 23 per 1000 in the control arm with 80% power and, 95% confidence and assuming 10% attrition. With this sample size, assuming alpha=0.0045 (Bonferroni adjusted for 11 tests), we also had 80% power to detect a risk ratio of 1.11 in application of substances to the cord or delaying first bath assuming 50% in controls.||1.02|1.00|0.093
72542457|NCT00106028|144614676|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.473||||0.6106|TWO_SIDED|95.0|-4.245|7.192|||ANCOVA|LS means and p-value are from ANCOVA model adjusted by baseline and fixed effects for age group, treatment and pooled center for post-baseline.||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.||7.192|-4.245|0.6106
72566561|NCT03291041|144663378|SUPERIORITY||Mean Difference (Net)|-1.0||||0.0765|TWO_SIDED||||||ANCOVA|||||||0.0765
72479183|NCT02079610|144484560|SUPERIORITY||Mean Difference (Final Values)|6.8|STANDARD_DEVIATION|3.5||0.01|TWO_SIDED||||||Mixed Models Analysis|||||||0.01
72479184|NCT01016977|144484563|SUPERIORITY_OR_OTHER|||||||0.9597||95.0||||Week 1|ANCOVA|||||||0.9597
72479185|NCT01016977|144484563|SUPERIORITY_OR_OTHER|||||||0.5538||95.0||||Week 2|ANCOVA|||||||0.5538
72479186|NCT01016977|144484563|SUPERIORITY_OR_OTHER|||||||0.6315||95.0||||Week 4|ANCOVA|||||||0.6315
72479187|NCT01016977|144484563|SUPERIORITY_OR_OTHER|||||||0.5655||95.0||||Week 8|ANCOVA|||||||0.5655
72479188|NCT01016977|144484563|SUPERIORITY_OR_OTHER|||||||0.7917||95.0||||Week 12|ANCOVA|||||||0.7917
72479189|NCT01016977|144484564|SUPERIORITY_OR_OTHER|||||||0.5961||95.0||||Week 1|ANCOVA|||||||0.5961
72479190|NCT01016977|144484564|SUPERIORITY_OR_OTHER|||||||0.2293||95.0||||Week 2|ANCOVA|||||||0.2293
72566562|NCT02985879|144663382|SUPERIORITY|The primary efficacy analysis utilized a likelihood-based, mixed-effects model, repeated measures (MMRM) analysis of the change from baseline for each postbaseline value and compared each ABBV-8E12 dose group with the placebo group. The model, which used all observed data, included fixed, categorical effects for treatment, site, visit, baseline score-by-visit interaction and treatment-by-visit interaction, with continuous fixed covariates for the corresponding baseline score.|LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|1.34|=|0.998|TWO_SIDED|95.0|-2.63|2.63|||Mixed-effects model, repeated measures||ABBV-8E12 2000 mg - Placebo|ABBV-8E12 2000 mg vs Placebo||2.63|-2.63|=0.998
72566563|NCT02985879|144663382|SUPERIORITY|The primary efficacy analysis utilized a likelihood-based, mixed-effects model, repeated measures (MMRM) analysis of the change from baseline for each postbaseline value and compared each ABBV-8E12 dose group with the placebo group. The model, which used all observed data, included fixed, categorical effects for treatment, site, visit, baseline score-by-visit interaction and treatment-by-visit interaction, with continuous fixed covariates for the corresponding baseline score.|LS Mean Difference|1.0|STANDARD_ERROR_OF_MEAN|1.32|=|0.464|TWO_SIDED|95.0|-1.63|3.58|||Mixed-effects model, repeated measures||ABBV-8E12 4000 mg - Placebo|ABBV-8E12 4000 mg vs Placebo||3.58|-1.63|=0.464
72566564|NCT02985879|144663384|SUPERIORITY|The analysis utilized a likelihood-based, mixed-effects model, repeated measures (MMRM) analysis of the change from baseline for each postbaseline value and compared each ABBV-8E12 dose group with the placebo group. The model, which used all observed data, included fixed, categorical effects for treatment, site, visit, baseline score-by-visit interaction and treatment-by-visit interaction, with continuous fixed covariates for the corresponding baseline score.|LS Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|0.88|=|0.812|TWO_SIDED|95.0|-1.52|1.93|||Mixed-effects model, repeated measures||ABBV-8E12 2000 mg - Placebo|ABBV-8E12 2000 mg vs Placebo||1.93|-1.52|=0.812
72566565|NCT02985879|144663384|SUPERIORITY|The analysis utilized a likelihood-based, mixed-effects model, repeated measures (MMRM) analysis of the change from baseline for each postbaseline value and compared each ABBV-8E12 dose group with the placebo group. The model, which used all observed data, included fixed, categorical effects for treatment, site, visit, baseline score-by-visit interaction and treatment-by-visit interaction, with continuous fixed covariates for the corresponding baseline score.|LS Mean Difference|1.4|STANDARD_ERROR_OF_MEAN|0.88|=|0.104|TWO_SIDED|95.0|-0.3|3.16|||Mixed-effects model, repeated measures||ABBV-8E12 4000 mg - Placebo|ABBV-8E12 4000 mg vs Placebo||3.16|-0.30|=0.104
72623609|NCT04938427|144778033|SUPERIORITY||Odds Ratio (OR)|1.91|||||TWO_SIDED|95.0|1.06|3.43||||||Disruptive Behaviors Domain||3.43|1.06|
72623610|NCT04938427|144778034|SUPERIORITY||Least Square Mean Difference|0.52|||||TWO_SIDED|95.0|-2.2|3.24||||||||3.24|-2.20|
72623611|NCT04938427|144778035|SUPERIORITY||Odds Ratio (OR)|1.67|||||TWO_SIDED|95.0|1.06|2.65||||||||2.65|1.06|
72623612|NCT04938427|144778036|SUPERIORITY||Hodges-Lehmann Location Shift Estimate|-6.37|||||TWO_SIDED|95.0|-16.83|4.16|||||The location shift between soticlestat and placebo (soticlestat - placebo) and its asymptotic 95% CI are based on the Hodges-Lehmann estimation.|||4.16|-16.83|
72479191|NCT01016977|144484564|SUPERIORITY_OR_OTHER|||||||0.9852||95.0||||Week 4|ANCOVA|||||||0.9852
72479192|NCT01016977|144484564|SUPERIORITY_OR_OTHER|||||||0.5538||95.0||||Week 8|ANCOVA|||||||0.5538
72479193|NCT01016977|144484564|SUPERIORITY_OR_OTHER|||||||0.654||95.0||||Week 12|ANCOVA|||||||0.6540
72479194|NCT01016977|144484565|SUPERIORITY_OR_OTHER|||||||0.8545||95.0||||Week 1|ANCOVA|||||||0.8545
72479195|NCT01016977|144484565|SUPERIORITY_OR_OTHER|||||||0.2895||95.0||||Week 2|ANCOVA|||||||0.2895
72479196|NCT01016977|144484565|SUPERIORITY_OR_OTHER|||||||0.8234||95.0||||Week 4|ANCOVA|||||||0.8234
72479197|NCT01016977|144484565|SUPERIORITY_OR_OTHER|||||||0.3644||95.0||||Week 8|ANCOVA|||||||0.3644
72542458|NCT00106028|144614677|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.315||||0.9372|TWO_SIDED|95.0|-7.598|8.229|||ANCOVA|LS means and p-value are from ANCOVA model adjusted by baseline and fixed effects for age group, treatment and pooled center for post-baseline.||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.||8.229|-7.598|0.9372
72623613|NCT04938427|144778037|SUPERIORITY||Hodges-Lehmann Location Shift Estimate|-6.65|||||TWO_SIDED|95.0|-16.67|3.12|||||The location shift between soticlestat and placebo (soticlestat - placebo) and its asymptotic 95% CI are based on the Hodges-Lehmann estimation.|||3.12|-16.67|
72623614|NCT04938427|144778038|SUPERIORITY||LS Mean Difference|2.47|||||TWO_SIDED|95.0|-1.74|6.67|||||A linear model with treatment group and age stratum as factors and baseline percentage as a covariate was used for analysis.|||6.67|-1.74|
72623615|NCT04938427|144778039|SUPERIORITY||LS Mean Difference|5.4|||||TWO_SIDED|95.0|1.9|8.9||||||||8.9|1.9|
72623616|NCT04938427|144778040|SUPERIORITY||LS Mean Difference|-0.9|||||TWO_SIDED|95.0|-3.7|2.0||||||||2.0|-3.7|
72623617|NCT01373281|144778043|SUPERIORITY_OR_OTHER_LEGACY||Vaccine efficacy|56.5|||||TWO_SIDED|95.0|43.8|66.4||||||The statistical methodology was based on the use of the two-sided 95% confidence interval (CI) of the vaccine efficacy (expressed in %). The CI was calculated using the exact method conditional on the total number of cases in both groups (exact method by Breslow \& Day). The vaccine efficacy of the CYD dengue vaccine was considered significant if the lower bound of its 95% CI was greater than 25%.||66.4|43.8|
72479198|NCT01016977|144484565|SUPERIORITY_OR_OTHER|||||||0.654||95.0||||Week 12|ANCOVA|||||||0.6540
72479199|NCT01016977|144484566|SUPERIORITY_OR_OTHER|||||||0.7546||95.0||||Week 1|ANCOVA|||||||0.7546
72479200|NCT01016977|144484566|SUPERIORITY_OR_OTHER|||||||0.7705||95.0||||Week 2|ANCOVA|||||||0.7705
72479201|NCT01016977|144484566|SUPERIORITY_OR_OTHER|||||||0.0259||95.0||||Week 4|ANCOVA|||||||0.0259
72479202|NCT01016977|144484566|SUPERIORITY_OR_OTHER|||||||0.9252||95.0||||Week 8|ANCOVA|||||||0.9252
72479203|NCT01016977|144484566|SUPERIORITY_OR_OTHER|||||||0.2927||95.0||||Week 12|ANCOVA|||||||0.2927
72479204|NCT01016977|144484567|SUPERIORITY_OR_OTHER|||||||0.401||95.0||||Week 1|ANCOVA|||||||0.4010
72479205|NCT01016977|144484567|SUPERIORITY_OR_OTHER|||||||0.0963||95.0||||Week 2|ANCOVA|||||||0.0963
72479206|NCT01016977|144484567|SUPERIORITY_OR_OTHER|||||||0.9291||95.0||||Week 4|ANCOVA|||||||0.9291
72479207|NCT01016977|144484567|SUPERIORITY_OR_OTHER|||||||0.5523||95.0||||Week 8|ANCOVA|||||||0.5523
72509247|NCT04598165|144548756|SUPERIORITY||Risk Ratio (RR)|1.03||||0.353|TWO_SIDED|95.0|0.97|1.09||The intention to treat analysis was adjusted for differences in exposure to other SMS programs and phone ownership. We corrected for multiple comparisons using the Benjamini-Hochberg method. The threshold for statistical significance was p=0.05.|Poisson regression||SMS group is the numerator|We estimated a sample size of 5000 to detect a risk ratio of ≤0.53 assuming a neonatal mortality rate of 23 per 1000 in the control arm with 80% power and, 95% confidence and assuming 10% attrition. With this sample size, assuming alpha=0.0045 (Bonferroni adjusted for 11 tests), we also had 80% power to detect a risk ratio of 1.11 in application of substances to the cord or delaying first bath assuming 50% in controls.||1.09|0.97|0.353
72509248|NCT04598165|144548757|SUPERIORITY||Risk Ratio (RR)|1.14||||0.751|TWO_SIDED|95.0|0.5|2.61||The intention to treat analysis was adjusted for differences in exposure to other SMS programs and phone ownership. We corrected for multiple comparisons using the Benjamini-Hochberg method. The threshold for statistical significance was p=0.05.|Poisson regression||SMS group is the numerator|We estimated a sample size of 5000 to detect a risk ratio of ≤0.53 assuming a neonatal mortality rate of 23 per 1000 in the control arm with 80% power and, 95% confidence and assuming 10% attrition. With this sample size, assuming alpha=0.0045 (Bonferroni adjusted for 11 tests), we also had 80% power to detect a risk ratio of 1.53 in provision of Kangaroo Mother Care assuming 25% in controls.||2.61|0.50|0.751
72400189|NCT04035161|144308104|SUPERIORITY||Mean Difference (Final Values)|2.38|||||TWO_SIDED|95.0|2.19|2.56||||||"Groin at 10 minutes post-product application.~Average treatment effect (ATE) of the Investigational Product compared to the Negative Control on the groin at 10 minutes post-product application. ATE was calculated using a linear regression model for each body site used for primary analysis. In the model, the response was the post-treatment log10 bacterial counts and predictors were the treatment effect as a fixed effect and the pre-treatment log10 bacterial counts as a covariate."||2.56|2.19|
72576843|NCT00261443|144680660|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.4||||0.022|TWO_SIDED|95.0|-0.74|-0.06||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 48 Comparison||-0.06|-0.74|0.022
72479208|NCT01016977|144484567|SUPERIORITY_OR_OTHER|||||||0.2556||95.0||||Week 12|ANCOVA|||||||0.2556
72479209|NCT01016977|144484568|SUPERIORITY_OR_OTHER|||||||0.4037||95.0||||Week 1|ANCOVA|||||||0.4037
72479210|NCT01016977|144484568|SUPERIORITY_OR_OTHER|||||||0.8662||95.0||||Week 2|ANCOVA|||||||0.8662
72479211|NCT01016977|144484568|SUPERIORITY_OR_OTHER|||||||0.5951||95.0||||Week 4|ANCOVA|||||||0.5951
72479212|NCT01016977|144484568|SUPERIORITY_OR_OTHER|||||||0.2349||95.0||||Week 8|ANCOVA|||||||0.2349
72479213|NCT01016977|144484568|SUPERIORITY_OR_OTHER|||||||0.3461||95.0||||Week 12|ANCOVA|||||||0.3461
72479214|NCT01016977|144484569|SUPERIORITY_OR_OTHER|||||||0.725||95.0||||Week 1|ANCOVA|||||||0.7250
72479215|NCT01016977|144484569|SUPERIORITY_OR_OTHER|||||||0.9743||95.0||||Week 2|ANCOVA|||||||0.9743
72576844|NCT00261443|144680660|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.4||||0.023|TWO_SIDED|95.0|-0.75|-0.06||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 52 Comparison||-0.06|-0.75|0.023
72576845|NCT00261443|144680662|SUPERIORITY_OR_OTHER_LEGACY||Difference|0.09||||0.486|TWO_SIDED|95.0|-0.17|0.36||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 4 Comparison||0.36|-0.17|0.486
72576846|NCT00261443|144680662|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.04||||0.793|TWO_SIDED|95.0|-0.3|0.23||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 8 Comparison||0.23|-0.30|0.793
72576847|NCT00261443|144680662|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.06||||0.665|TWO_SIDED|95.0|-0.34|0.22||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 12 Comparison||0.22|-0.34|0.665
72576848|NCT00261443|144680662|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.07||||0.65|TWO_SIDED|95.0|-0.35|0.22||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 16 Comparison||0.22|-0.35|0.650
72576849|NCT00261443|144680662|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.06||||0.705|TWO_SIDED|95.0|-0.34|0.23||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 20 Comparison||0.23|-0.34|0.705
72576850|NCT00261443|144680662|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.08||||0.572|TWO_SIDED|95.0|-0.38|0.21||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 24 Comparison||0.21|-0.38|0.572
72479216|NCT01016977|144484569|SUPERIORITY_OR_OTHER|||||||0.9816||95.0||||Week 4|ANCOVA|||||||0.9816
72479217|NCT01016977|144484569|SUPERIORITY_OR_OTHER|||||||0.8809||95.0||||Week 8|ANCOVA|||||||0.8809
72479218|NCT01016977|144484569|SUPERIORITY_OR_OTHER|||||||0.1679||95.0||||Week 12|ANCOVA|||||||0.1679
72479219|NCT00522873|144484621|SUPERIORITY_OR_OTHER||proportion|0.0|||||TWO_SIDED|95.0|0.0|0.0119|||||The number of women who had a biopsy classified as 'hyperplasia or worse' was divided by the number of women with an evaluable biopsy (i.e. classified as 'normal' after 1 year of treatment or as 'hyperplasia or worse' at any time during the study).|Exact 95% confidence interval for proportion of participants with hyperplasia or worse at EoS||0.0119|0.0000|
72509249|NCT04598165|144548758|SUPERIORITY||Risk Ratio (RR)|1.0||||0.431|TWO_SIDED|95.0|1.0|1.01||The intention to treat analysis was adjusted for differences in exposure to other SMS programs and phone ownership. We corrected for multiple comparisons using the Benjamini-Hochberg method. The threshold for statistical significance was p=0.05.|Poisson generalized estimating equations||n (%) are values at 6-week visit, and RR compares change over time for enrollment, 2- and 6-week visits. SMS group is the numerator.|We estimated a sample size of 5000 to detect a risk ratio of ≤0.53 assuming a neonatal mortality rate of 23 per 1000 in the control arm with 80% power and, 95% confidence and assuming 10% attrition. With this sample size, assuming alpha=0.0045 (Bonferroni adjusted for 11 tests), we also had 80% power to detect a risk ratio of 1.04 in number of danger signs correctly named assuming median of 3 in controls.||1.01|1.00|0.431
72509250|NCT04598165|144548759|SUPERIORITY||Risk Ratio (RR)|1.03||||0.321|TWO_SIDED|95.0|0.98|1.08||The intention to treat analysis was adjusted for differences in exposure to other SMS programs and phone ownership. We corrected for multiple comparisons using the Benjamini-Hochberg method. The threshold for statistical significance was p=0.05.|Poisson regression||SMS group is the numerator.|We estimated a sample size of 5000 to detect a risk ratio of ≤0.53 assuming a neonatal mortality rate of 23 per 1000 in the control arm with 80% power and, 95% confidence and assuming 10% attrition. With this sample size, assuming alpha=0.0045 (Bonferroni adjusted for 11 tests), we also had 80% power to detect a risk ratio of 1.11 in appropriate care seeking assuming 1 clinic visit in the 6-weeks postpartum for controls.||1.08|0.98|0.321
72509251|NCT04598165|144548760|SUPERIORITY||Risk Ratio (RR)|1.01||||0.65|TWO_SIDED|95.0|0.98|1.04||The intention to treat analysis was adjusted for differences in exposure to other SMS programs and phone ownership. We corrected for multiple comparisons using the Benjamini-Hochberg method. The threshold for statistical significance was p=0.05.|Poisson generalized estimating equations||n (%) are values at 6-week visit, and RR compares change over time for enrollment, 2- and 6-week visits. SMS group is the numerator.|We estimated a sample size of 5000 to detect a risk ratio of ≤0.53 assuming a neonatal mortality rate of 23 per 1000 in the control arm with 80% power and, 95% confidence and assuming 10% attrition. With this sample size, assuming alpha=0.0045 (Bonferroni adjusted for 11 tests), we also had 80% power to detect a risk ratio of 0.76 in elevated depression symptoms assuming 19% in controls.||1.04|0.98|0.650
72623618|NCT01373281|144778046|SUPERIORITY_OR_OTHER_LEGACY||Vaccine Efficacy|55.4|||||TWO_SIDED|95.0|47.3|62.3||||||The statistical methodology was based on the use of the two-sided 95% CI of the vaccine efficacy (expressed in %) calculated using the exact method conditional on the total number of cases in both groups.||62.3|47.3|
72623619|NCT01373281|144778047|SUPERIORITY_OR_OTHER_LEGACY||Vaccine Efficacy|57.9|||||TWO_SIDED|95.0|49.0|65.2||||||The statistical methodology was based on the use of the two-sided 95% CI of the vaccine efficacy (expressed in %) calculated using the exact method conditional on the total number of cases in both groups.||65.2|49.0|
72479220|NCT00522873|144484622|SUPERIORITY_OR_OTHER||proportion|0.687|||||TWO_SIDED|95.0|0.637|0.734||||||exact 95% confidence intervall (Clopper-Pearson) for proportion of participants with amenorrhea||0.734|0.637|
72479221|NCT00522873|144484622|SUPERIORITY_OR_OTHER||proportion|0.593|||||TWO_SIDED|95.0|0.496|0.684||||||exact 95% confidence intervall (Clopper-Pearson) for proportion of participants with amenorrhea||0.684|0.496|
72623620|NCT01373281|144778048|SUPERIORITY_OR_OTHER_LEGACY||Vaccine Efficacy|54.8|||||TWO_SIDED|95.0|46.8|61.7||||||The statistical methodology was based on the use of the two-sided 95% CI of the vaccine efficacy (expressed in %) calculated using the exact method conditional on the total number of cases in both groups.||61.7|46.8|
72623621|NCT00734032|144778063|SUPERIORITY||Ratio|0.514|||<|0.001|TWO_SIDED|95.0|0.449|0.59|||ANCOVA||The point estimate was calculated as adjusted geometric mean ratio of placebo and SB-480848 40 mg. Dunnett adjustment was used for comparison of each dose group to placebo.|||0.590|0.449|<.001
72623622|NCT00734032|144778063|SUPERIORITY||Ratio|0.421|||<|0.001|TWO_SIDED|95.0|0.367|0.483|||ANCOVA||The point estimate was calculated as adjusted geometric mean ratio of placebo and SB-480848 80 mg. Dunnett adjustment was used for comparison of each dose group to placebo.|||0.483|0.367|<.001
72479222|NCT00522873|144484623|SUPERIORITY_OR_OTHER||proportion|0.789|||||TWO_SIDED|95.0|0.743|0.83||||||exact 95% confidence intervall (Clopper-Pearson) for proportion of participants with amenorrhea||0.830|0.743|
72479223|NCT00522873|144484623|SUPERIORITY_OR_OTHER||proportion|0.84|||||TWO_SIDED|95.0|0.756|0.904||||||exact 95% confidence intervall (Clopper-Pearson) for proportion of participants with amenorrhea||0.904|0.756|
72479224|NCT00666679|144484633|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least-Squares Means|0.05||||0.033||95.0|0.0|0.09|||Mixed Models Analysis|Model with fixed effects for treatment, time (weeks 1 and 2), treatment-by-time interaction, period and baseline covariate.|Least-Squares Means for average change from baseline are derived using appropriate contrast from mixed model with fixed effects for treatment, time (weeks 1 and 2), treatment-by-time interaction, period and baseline covariate.|||0.09|0.00|0.033
72479225|NCT00666679|144484634|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least-Squares Means|-0.15||||0.005||95.0|-0.26|-0.05|||Mixed Models Analysis|Model with fixed effects for treatment, time (weeks 1 and 2), treatment-by-time interaction, period and baseline covariate.|Least-Squares Means for average change from baseline are derived using appropriate contrast from mixed model with fixed effects for treatment, time (weeks 1 and 2), treatment-by-time interaction, period and baseline covariate.|||-0.05|-0.26|0.005
72479226|NCT00666679|144484635|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least-Squares Means|-0.09||||0.015||95.0|-0.17|-0.02|||Mixed Models Analysis|Model with fixed effects for treatment, time (weeks 1 and 2), treatment-by-time interaction, period and baseline covariate.|Least-Squares Means for average change from baseline are derived using appropriate contrast from mixed model with fixed effects for treatment, time (weeks 1 and 2), treatment-by-time interaction, period and baseline covariate.|||-0.02|-0.17|0.015
72623623|NCT00734032|144778063|SUPERIORITY||Ratio|0.326|||<|0.001|TWO_SIDED|95.0|0.284|0.375|||ANCOVA||The point estimate was calculated as adjusted geometric mean ratio of placebo and SB-480848 160 mg. Dunnett adjustment was used for comparison of each dose group to placebo.|||0.375|0.284|<.001
72623624|NCT01342666|144778070|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.1154|STANDARD_ERROR_OF_MEAN|0.9057|<|0.0001|TWO_SIDED|95.0|3.2925|6.9383||We did only one comparison. The a priori threshold for statistical significance was \<0.05.|t-test, 2 sided||We compare de mean difference of the delta (final-basal levels) between groups. The values posted are the difference found in the tomato group in comparison of the control group. The mean represent the increment of HDL-c in the tomato group.|We test the effect of two daily roma tomatoes during one month in HDL-c levels. We estimate the sample size to have a 80% study power.||6.9383|3.2925|<0.0001
72623625|NCT01342666|144778070|SUPERIORITY_OR_OTHER||Slope|5.656|STANDARD_ERROR_OF_MEAN|0.789|<|0.0001|TWO_SIDED|95.0|4.027|7.232||A priori p value of \<0.05|Regression, Linear|Adjusted for adherence, smoking, age, gender, waist to hip ratio, triglycerides, body mass index, exercise, omega 3, alcohol, fish, simple sugars.|Parameters of the model: F= 4.06; r = 0.798; r2 = 0.638; p=0.001|||7.232|4.027|<0.0001
72623626|NCT00600340|144778098|NON_INFERIORITY|"Null hypothesis: Hazard Ratio (HR) \>= 1.33~Based on Cox proportional hazards model adjusted by stratification factors at randomization:~1. estrogen and/or progesterone status (positive vs. other)~2. country~3. menopausal status (premenopausal or male \<=50 years of age vs. postmenopausal or male \>50 years of age)"|Hazard Ratio (HR)|1.042||||0.1983|ONE_SIDED|97.5||1.689||Based on approach using repeated confidence intervals, with one-sided 97.5% repeated confidence intervals|Regression, Cox||HR is the hazard rate of Bevacizumab plus Capecitabine divided by hazard rate of Bevacizumab plus Paclitaxel.|HR of Bevacizumab plus Capecitabine vs. Bevacizumab plus Paclitaxel for OS (interim, stratified).||1.689||0.1983
72623627|NCT00600340|144778098|NON_INFERIORITY|"Null hypothesis: Hazard Ratio (HR) \>= 1.33~Based on Cox proportional hazards model adjusted by stratification factors at randomization:~1. estrogen and/or progesterone status (positive vs. other)~2. country~3. menopausal status (premenopausal or male \<=50 years of age vs. postmenopausal or male \>50 years of age)"|Hazard Ratio (HR)|1.018||||0.007|ONE_SIDED|97.5||1.261||Based on approach using repeated confidence intervals, with one-sided 97.5% repeated confidence intervals. Non-inferiority margin was a HR of 1.33.|Regression, Cox||HR is the hazard rate of Bevacizumab Plus Capecitabine divided by hazard rate of Bevacizumab plus Paclitaxel.|HR of Bevacizumab Plus Capecitabine vs. Bevacizumab plus Paclitaxel for OS (final, stratified).||1.261||0.0070
72479227|NCT00666679|144484636|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least-Squares Means|-0.6||||0.073||95.0|-1.26|0.06|||Mixed Models Analysis|Model with fixed effects for treatment, time (weeks 1 and 2), treatment-by-time interaction, period and baseline covariate.|Least-Squares Means for average change from baseline are derived using appropriate contrast from mixed model with fixed effects for treatment, time (weeks 1 and 2), treatment-by-time interaction, period and baseline covariate.|||0.06|-1.26|0.073
72479228|NCT00666679|144484637|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least-Squares Means|6.08||||0.004||95.0|1.94|10.23|||Mixed Models Analysis|Model with fixed effects for treatment, time (weeks 1 and 2), treatment-by-time interaction and period.|Least-Squares Means for average percentage of days are derived using appropriate contrast from mixed model with fixed effects for treatment, time (weeks 1 and 2), treatment-by-time interaction and period.|||10.23|1.94|0.004
72479229|NCT00666679|144484638|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least-Squares Means|-5.43|||<=|0.001||95.0|-8.67|-2.19|||ANCOVA|Model with terms for patient, treatment and period.|Least-Squares Means for percentage of days are derived from ANCOVA model with terms for patient, treatment and period.|||-2.19|-8.67|<=0.001
72479230|NCT00666679|144484639|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least-Squares Means|-0.07||||0.013||95.0|-0.12|-0.01|||Mixed Models Analysis|Model with fixed effects for treatment, period and baseline covariate.|Least-Squares Means for change from baseline are derived from mixed model with terms for treatment, period and baseline covariate.|||-0.01|-0.12|0.013
72479231|NCT00666679|144484640|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least-Squares Means|0.08||||0.002||95.0|0.03|0.13|||Mixed Models Analysis|Model with fixed effects for treatment, time (weeks 1 and 2), treatment-by-time interaction, period and baseline covariate.|Least-Squares Means for average change from baseline are derived using appropriate contrast from mixed model with fixed effects for treatment, time (weeks 1 and 2), treatment-by-time interaction, period and baseline covariate.|||0.13|0.03|0.002
72479232|NCT05062759|144484653|OTHER||Geometric Least square (LS) mean ratio|0.65|||||TWO_SIDED|90.0|0.43|0.98||||||Influenza A H1N1 Ratio of placebo over tezepelumab. Results based on ANCOVA model.||0.98|0.43|
72479233|NCT05062759|144484653|OTHER||Geometeric LS mean ratio|0.83|||||TWO_SIDED|90.0|0.6|1.15||||||Influenza B Yamagata Lineage Ratio of placebo over tezepelumab. Results based on ANCOVA model||1.15|0.60|
72479234|NCT05062759|144484653|OTHER||Geometric LS mean ratio|0.99|||||TWO_SIDED|90.0|0.71|1.37||||||Influenza B Victoria Lineage Ratio of placebo over tezepelumab. Results based on ANCOVA model||1.37|0.71|
72479235|NCT05062759|144484654|OTHER||Geometeric LS mean ratio|0.73|||||TWO_SIDED|90.0|0.42|1.28||||||Influenza A H1N1 Ratio of placebo over tezepelumab. Results based on ANCOVA model||1.28|0.42|
72479236|NCT05062759|144484654|OTHER||Geometeric LS mean ratio|1.25|||||TWO_SIDED|90.0|0.72|2.17||||||Influenza A H3N2 Ratio of placebo over tezepelumab. Results based on ANCOVA model||2.17|0.72|
72479237|NCT05062759|144484654|OTHER||Geometric LS mean ratio|1.23|||||TWO_SIDED|90.0|0.73|2.07||||||Influenza B Victoria Lineage Ratio of placebo over tezepelumab. Results based on ANCOVA model||2.07|0.73|
72479238|NCT05062759|144484654|OTHER||Geometeric LS mean ratio|0.89|||||TWO_SIDED|90.0|0.54|1.48||||||Influenza B Yamagata Lineage Ratio of placebo over tezepelumab. Results based on ANCOVA model||1.48|0.54|
72479239|NCT05062759|144484655|OTHER||Geometeric LS mean ratio|0.74|||||TWO_SIDED|90.0|0.52|1.04||||||Influenza A H1N1 Ratio of placebo over tezepelumab. Results based on ANCOVA model||1.04|0.52|
72479240|NCT05062759|144484655|OTHER||Geometeric LS mean ratio|0.96|||||TWO_SIDED|90.0|0.72|1.29||||||Influenza B Yamagata Lineage Ratio of placebo over tezepelumab. Results based on ANCOVA model||1.29|0.72|
72479241|NCT05062759|144484655|OTHER||Geometric LS mean ratio|1.03|||||TWO_SIDED|90.0|0.73|1.46||||||Influenza B Victoria Lineage Ratio of placebo over tezepelumab. Results based on ANCOVA model||1.46|0.73|
72479242|NCT05062759|144484656|OTHER||Geometeric LS mean ratio|0.79|||||TWO_SIDED|90.0|0.51|1.25||||||Influenza A H1N1 Ratio of placebo over tezepelumab. Results based on ANCOVA model||1.25|0.51|
72400190|NCT04035161|144308107|NON_INFERIORITY|A non-inferiority criterion with a 0.5 log10 margin will be implemented for the average treatment effect (ATE) of the Investigational Product compared to the Active Control (i.e., the upper two-sided 95% confidence bound of the post-product application bacterial load corrected for pre-product application bacterial load of the Investigational Product - Active Control should be less than 0.5 log10).|Mean Difference (Final Values)|0.08|||||TWO_SIDED|95.0|-0.08|0.23||||||"Abdomen at 30 seconds post-product application.~Average treatment effect (ATE) of the Investigational Product compared to the Active Control on the abdomen at 30 seconds post-product application. ATE was calculated using a linear regression model for each body site used for primary analysis. In the model, the response was the post-treatment log10 bacterial counts and predictors were the treatment effect as a fixed effect and the pre-treatment log10 bacterial counts as a covariate."||0.23|-0.08|
72509252|NCT04598165|144548761|SUPERIORITY||Coefficient|0.09||||0.071|TWO_SIDED|95.0|-0.007|0.18||The intention to treat analysis was adjusted for differences in exposure to other SMS programs and phone ownership. We corrected for multiple comparisons using the Benjamini-Hochberg method. The threshold for statistical significance was p=0.05.|Linear generalized estimating equations||n (%) are values at 6-week visit, and RR compares change over time for enrollment, 2- and 6-week visits. SMS group is the numerator. Coefficient (95% CI) for linear GEE using enrollment, 2- and 6-week visits.|||0.18|-0.007|0.071
72509253|NCT04598165|144548762|SUPERIORITY||Coefficient|0.02||||0.19|TWO_SIDED|95.0|-0.01|0.04||The intention to treat analysis was adjusted for differences in exposure to other SMS programs and phone ownership. We corrected for multiple comparisons using the Benjamini-Hochberg method. The threshold for statistical significance was p=0.05.|Linear generalized estimating equations||n (%) are values at 6-week visit, and RR compares change over time for enrollment, 2- and 6-week visits. SMS group is the numerator. Coefficient (95% CI) for linear GEE using enrollment, 2- and 6-week visits.|||0.04|-0.01|0.190
72509254|NCT00426751|144548772|NON_INFERIORITY_OR_EQUIVALENCE|For the assessment of differences between both treatment groups, a generalized model (under binomial probability distribution), adjusted for center, was applied.|Median Difference (Final Values)|2.1||||||90.0|-8.5|12.8||||||||12.8|-8.5|
72509255|NCT00426751|144548773|NON_INFERIORITY_OR_EQUIVALENCE|For the assessment of differences between both treatment groups a generalised model (under binomial probability distribution), adjusted for centre, was applied.|Mean Difference (Final Values)|6.8||||||95.0|-3.0|16.6|||||Analysis based on the ITT population confirmed the results observed in the PP population.|||16.6|-3.0|
72509256|NCT04400318|144548814|SUPERIORITY||Odds Ratio (OR)|9.81|||<|0.001|TWO_SIDED|95.0|3.13|30.82|||Cochran-Mantel-Haenszel|||Odds Ratio, 95% confidence interval (CI) of the odds ratio and p-value between the dupilumab and placebo group based on the Cochran-Mantel-Haenszel (CMH) test adjusted by ICS dose level (medium/high) and region (Eastern Europe/ROW).||30.82|3.13|<0.001
72509257|NCT04400318|144548815|SUPERIORITY||Least square mean difference|21.76|STANDARD_ERROR_OF_MEAN|14.022||0.138|TWO_SIDED|95.0|-7.73|51.25|||MMRM|||The mixed model for repeated measures (MMRM) included study intervention, baseline value, region, ICS dose level, visits, study intervention by visit interaction, and baseline by visit interaction terms all as fixed effects. Region, ICS, study intervention and visits were considered as categorical parameters.||51.25|-7.73|0.138
72509258|NCT04400318|144548816|SUPERIORITY|A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measure is reported and continued when previous outcome measure was statistically significant at two-sided 0.05. Only 2 secondary outcome measures (#4 and #5) were included in this procedure.|Least square mean difference|-4.92|STANDARD_ERROR_OF_MEAN|0.798|<|0.001|TWO_SIDED|95.0|-6.5|-3.34|||MMRM|||MMRM model included study intervention (dupilumab, placebo), baseline value of global lung UCSF mucus scoring, region (Eastern Europe/ROW), ICS dose level (medium/high), visit (up to Week 24), study intervention-by-visit interaction and baseline-by-visit interaction as covariates.||-3.34|-6.50|<0.001
72509259|NCT04400318|144548817|SUPERIORITY|A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measure is reported and continued when previous outcome measure was statistically significant at two-sided 0.05. Only 2 secondary outcome measures (#4 and #5) were included in this procedure.|Least square mean difference|-53.45|STANDARD_ERROR_OF_MEAN|39.562||0.18|TWO_SIDED|95.0|-132.09|25.19|||MMRM|||MMRM model included study intervention (dupilumab, placebo), baseline value of trimmed distal \[s\]iRaw at TLC, region (Eastern Europe/ROW), ICS dose level (medium/high), visit (up to Week 24), study intervention-by-visit interaction, and baseline-by-visit interaction as covariates.||25.19|-132.09|0.180
72509260|NCT01096446|144548827|NON_INFERIORITY_OR_EQUIVALENCE|The Chi Square satistical calculation was used for analysis.||||||0.011|TWO_SIDED|95.0|||||Chi-squared|||Four infants(44%)in the control group developed hypertriglyceridemia (\>200 mg/dl) while 100% of the infants in the experimental group developed hypertriglyceridemia (\>200 mg/dl) during the first week of life.||||0.011
72509261|NCT04657016|144548833|SUPERIORITY||Mean Difference (Net)|-24.5|||<|0.001|TWO_SIDED|95.0|-26.1|-22.8|||Mixed Models Analysis|||||-22.8|-26.1|<0.001
72509262|NCT04657016|144548834|SUPERIORITY||Odds Ratio (OR)|130.36|||<|0.001|TWO_SIDED|95.0|69.98|242.84|||Regression, Logistic|||||242.84|69.98|<0.001
72509263|NCT04657016|144548835|SUPERIORITY||Odds Ratio (OR)|101.6|||<|0.001|TWO_SIDED|95.0|39.17|263.55|||Regression, Logistic|||||263.55|39.17|<0.001
72509264|NCT04657016|144548836|SUPERIORITY||Odds Ratio (OR)|153.95|||<|0.001|TWO_SIDED|95.0|78.9|300.37|||Regression, Logistic|||||300.37|78.90|<0.001
72509265|NCT04657016|144548837|SUPERIORITY||Odds Ratio (OR)|144.48|||<|0.001|TWO_SIDED|95.0|62.65|333.21|||Regression, Logistic|||||333.21|62.65|<0.001
72509266|NCT04657016|144548838|SUPERIORITY||Odds Ratio (OR)|118.06|||<|0.001|TWO_SIDED|95.0|40.08|347.74|||Regression, Logistic|||||347.74|40.08|<0.001
72509267|NCT04657016|144548839|SUPERIORITY||Mean Difference (Net)|-17.9|||<|0.001|TWO_SIDED|95.0|-19.5|-16.3|||Mixed Models Analysis|||||-16.3|-19.5|<0.001
72509268|NCT04657016|144548840|SUPERIORITY||Mean Difference (Net)|-25.0|||<|0.001|TWO_SIDED|95.0|-26.9|-23.2|||Mixed Models Analysis|||||-23.2|-26.9|<0.001
72509269|NCT04657016|144548841|SUPERIORITY||Mean Difference (Net)|-8.9|||<|0.001|TWO_SIDED|95.0|-9.6|-8.3|||Mixed Models Analysis|||||-8.3|-9.6|<0.001
72509270|NCT04657016|144548842|SUPERIORITY||Mean Difference (Net)|-10.2|||<|0.001|TWO_SIDED|95.0|-12.2|-8.1|||Mixed Models Analysis|||||-8.1|-12.2|<0.001
72509271|NCT04657016|144548843|SUPERIORITY||Mean Difference (Net)|-5.7|||<|0.001|TWO_SIDED|95.0|-7.2|-4.3|||Mixed Models Analysis|||||-4.3|-7.2|<0.001
72566566|NCT02985879|144663385|SUPERIORITY|The analysis utilized a likelihood-based, mixed-effects model, repeated measures (MMRM) analysis of the change from baseline for each postbaseline value and compared each ABBV-8E12 dose group with the placebo group. The model, which used all observed data, included fixed, categorical effects for treatment, site, visit, baseline score-by-visit interaction and treatment-by-visit interaction, with continuous fixed covariates for the corresponding baseline score.|LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.16|=|0.756|TWO_SIDED|95.0|-0.36|0.26|||Mixed-effects model, repeated measures||ABBV-8E12 2000 mg - Placebo|ABBV-8E12 2000 mg vs Placebo||0.26|-0.36|=0.756
72623628|NCT00600340|144778098|NON_INFERIORITY|Null hypothesis: Hazard Ratio (HR) \>= 1.33 Based on Cox proportional hazards model.|Hazard Ratio (HR)|1.058||||0.2024|ONE_SIDED|97.5||1.674||Based on approach using repeated confidence intervals, with one-sided 97.5% repeated confidence intervals. Non-inferiority margin was a HR of 1.33.|Regression, Cox||HR is the hazard rate of Bevacizumab Plus Capecitabine divided by hazard rate of Bevacizumab plus Paclitaxel.|HR of Bevacizumab Plus Capecitabine vs. Bevacizumab plus Paclitaxel for OS (interim, unstratified).||1.674||0.2024
72400191|NCT04035161|144308107|SUPERIORITY||Mean Difference (Final Values)|1.99|||||TWO_SIDED|95.0|1.84|2.15||||||"Abdomen at 30 seconds post-product application.~Average treatment effect (ATE) of the Investigational Product compared to the Negative Control on the abdomen at 30 seconds post-product application. ATE was calculated using a linear regression model for each body site used for primary analysis. In the model, the response was the post-treatment log10 bacterial counts and predictors were the treatment effect as a fixed effect and the pre-treatment log10 bacterial counts as a covariate."||2.15|1.84|
72400192|NCT03479307|144308157|SUPERIORITY||Mean Difference (Final Values)|-0.71|||<|0.0001|TWO_SIDED|95.0|-1.013|-0.407|||ANCOVA|||Treatment Difference (95% CI): Bilastine Ophthalmic Solution 0.6% arm minus Vehicle of Bilastine Ophthalmic Solution arm at Visit 4b (including all time points).||-0.407|-1.013|< 0.0001
72400193|NCT03479307|144308157|SUPERIORITY||Mean Difference (Final Values)|-1.167|||<|0.0001|TWO_SIDED|95.0|-1.439|-0.895|||ANCOVA|||Treatment Difference (95% CI): Bilastine Ophthalmic Solution 0.6% arm minus Vehicle of Bilastine Ophthalmic Solution arm at Visit 5 (including all time points).||-0.895|-1.439|< 0.0001
72479243|NCT05062759|144484656|OTHER||Geometeric LS mean ratio|0.76|||||TWO_SIDED|90.0|0.42|1.28||||||Influenza A H3N2 Ratio of placebo over tezepelumab. Results based on ANCOVA model||1.28|0.42|
72479244|NCT05062759|144484656|OTHER||Geometric LS mean ratio|0.99|||||TWO_SIDED|90.0|0.49|1.99||||||Influenza B Victoria Lineage Ratio of placebo over tezepelumab. Results based on ANCOVA model||1.99|0.49|
72479245|NCT05062759|144484656|OTHER||Geometeric LS mean ratio|1.03|||||TWO_SIDED|90.0|0.7|1.52||||||Influenza B Yamagata Lineage Ratio of placebo over tezepelumab. Results based on ANCOVA model||1.52|0.70|
72400194|NCT03479307|144308157|SUPERIORITY||Mean Difference (Final Values)|-1.14|||<|0.0001|TWO_SIDED|95.0|-1.413|-0.868|||ANCOVA|||Treatment Difference (95% CI): Ketotifen Ophthalmic Solution 0.025% (Zaditen) arm minus Vehicle of Bilastine Ophthalmic Solution arm at Visit 5 (including all time points).||-0.868|-1.413|< 0.0001
72400195|NCT03479307|144308157|NON_INFERIORITY|Non-inferiority margin of 0.40|Mean Difference (Final Values)|0.009||||0.0007|ONE_SIDED|97.5||0.235|||ANCOVA|||Treatment Difference (one-sided, 97.5% CI): Bilastine Ophthalmic Solution 0.6% arm minus Ketotiphen Ophthalmic Solution 0.025% (Zaditen) arm at Visit 5, 3 minutes Post-CAC (non-inferiority test).||0.235||0.0007
72400196|NCT03479307|144308157|NON_INFERIORITY|Non-inferiority margin of 0.40|Mean Difference (Final Values)|-0.077||||0.0002|ONE_SIDED|97.5||0.175|||ANCOVA|||Treatment Difference (one-sided, 97.5% CI): Bilastine Ophthalmic Solution 0.6% arm minus Ketotiphen Ophthalmic Solution 0.025% (Zaditen) arm at Visit 5, 5 minutes Post-CAC (non-inferiority test).||0.175||0.0002
72509272|NCT04657016|144548844|SUPERIORITY||Mean Difference (Net)|-7.79|STANDARD_ERROR_OF_MEAN|1.348|<|0.001|TWO_SIDED|95.0|-10.4|-5.1|||Mixed Models Analysis|||||-5.10|-10.40|<0.001
72509273|NCT04657016|144548845|SUPERIORITY||Mean Difference (Net)|11.4|STANDARD_ERROR_OF_MEAN|1.67|<|0.001|TWO_SIDED|95.0|8.2|14.7|||Mixed Models Analysis|||||14.7|8.2|<0.001
72479246|NCT00477334|144484713|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.26||||0.4161|TWO_SIDED|95.0|-0.4|0.98|||Hodges-Lehman Shift Model||Difference in time to healing= time to healing for Famciclovir-time to healing for Placebo. Hodges-Lehman shift model is used to estimate the difference in treatment effect. P-value is from the Wilcoxon rank-sum test.|Participants who discontinued from the study before healing of non-aborted lesions was confirmed and participants who completed the study 21 days since treatment initiation without non-aborted lesion stages and without a final assessment on aborted lesion status are imputed according to the distribution of the time to healing among the subjects in the placebo group whose time to healing is greater than or equal to the observed discontinuation time. (Censor time)||0.98|-0.40|0.4161
72509274|NCT04657016|144548846|SUPERIORITY||Mean Difference (Net)|-11.5|STANDARD_ERROR_OF_MEAN|1.97|<|0.001|TWO_SIDED|95.0|-15.3|-7.53|||Mixed Models Analysis|||||-7.53|-15.30|<0.001
72509275|NCT04657016|144548847|SUPERIORITY||Mean Difference (Net)|-27.8|STANDARD_ERROR_OF_MEAN|2.25|<|0.001|TWO_SIDED|95.0|-32.1|-23.2|||Mixed Models Analysis|||||-23.2|-32.1|<0.001
72509276|NCT04657016|144548848|SUPERIORITY||Mean Difference (Net)|-28.0|STANDARD_ERROR_OF_MEAN|2.26|<|0.001|TWO_SIDED|95.0|-32.3|-23.4|||Mixed Models Analysis|||||-23.4|-32.3|<0.001
72509277|NCT04657016|144548849|SUPERIORITY||Mean Difference (Net)|-21.3|STANDARD_ERROR_OF_MEAN|3.76|<|0.001|TWO_SIDED|95.0|-28.4|-13.6|||Mixed Models Analysis|||||-13.6|-28.4|<0.001
72509278|NCT04657016|144548850|SUPERIORITY||Mean Difference (Net)|-11.2|||<|0.001|TWO_SIDED|95.0|-13.5|-8.8|||Mixed Models Analysis|||||-8.8|-13.5|<0.001
72509279|NCT04657016|144548851|SUPERIORITY||Mean Difference (Net)|-0.47|||<|0.001|TWO_SIDED|95.0|-0.53|-0.42|||Mixed Models Analysis|||||-0.42|-0.53|<0.001
72509280|NCT04657016|144548852|SUPERIORITY||Mean Difference (Net)|-48.1|STANDARD_ERROR_OF_MEAN|3.04|<|0.001|TWO_SIDED|95.0|-53.7|-41.7|||Mixed Models Analysis|||||-41.7|-53.7|<0.001
72509281|NCT04657016|144548853|SUPERIORITY||Mean Difference (Net)|3.8|||<|0.001|TWO_SIDED|95.0|2.8|4.9|||ANCOVA|||||4.9|2.8|<0.001
72509282|NCT04657016|144548854|SUPERIORITY||Mean Difference (Net)|12.8|||<|0.001|TWO_SIDED|95.0|9.7|16.0|||ANCOVA|||||16.0|9.7|<0.001
72509283|NCT03470922|144548862|SUPERIORITY||Cox Proportional Hazard|0.75||||0.0055|TWO_SIDED|95.0|0.62|0.92|||Log Rank|Log-rank test stratified by LAG-3 (≥ 1% vs \< 1%), BRAF (mutation positive vs mutation wild-type), AJCC M-stage (M0/M1any\[0\] vs M1any\[1\])||||0.92|0.62|0.0055
72400197|NCT03479307|144308157|NON_INFERIORITY|Non-inferiority margin of 0.40|Mean Difference (Final Values)|-0.159|||<|0.0001|ONE_SIDED|97.5||0.101|||ANCOVA|||Treatment Difference (one-sided, 97.5% CI): Bilastine Ophthalmic Solution 0.6% arm minus Ketotiphen Ophthalmic Solution 0.025% (Zaditen) arm at Visit 5, 7 minutes Post-CAC (non-inferiority test).||0.101||< 0.0001
72400198|NCT02295995|144308165|OTHER|||||||||||||||||The between-group difference at 12 weeks \[mean difference (MD) and 95% Confidence Interval\] was calculated for all outcome measures. Cohen's d effect sizes were calculated as the difference in mean-level change (from baseline to 12 weeks) between the two groups divided by the standard deviation (SD) and is interpreted as d=0.20 (small), d=0.50 (medium), and d=0.80 (large). Cohen's d for physical activity in this sample was 1.37|Cohen's d calculated as the change from baseline to 12 weeks in both groups.|||
72400199|NCT02295995|144308166|OTHER|||||||||||||||||The between-group difference at 12 weeks \[mean difference (MD) and 95% Confidence Interval\] was calculated for all outcome measures. Cohen's d effect sizes were calculated as the difference in mean-level change (from baseline to 12 weeks) between the two groups divided by the standard deviation (SD) and is interpreted as d=0.20 (small), d=0.50 (medium), and d=0.80 (large). Cohen's d for PCL-5 in this sample was 0.38|Cohen's d calculated as the change from baseline to 12 weeks in both groups.|||
72400200|NCT02295995|144308167|OTHER|||||||||||||||||The between-group difference at 12 weeks \[mean difference (MD) and 95% Confidence Interval\] was calculated for all outcome measures. Cohen's d effect sizes were calculated as the difference in mean-level change (from baseline to 12 weeks) between the two groups divided by the standard deviation (SD) and is interpreted as d=0.20 (small), d=0.50 (medium), and d=0.80 (large). Cohen's d for 6-minute walk in this sample was 0.50|Cohen's d calculated as the change from baseline to 12 weeks in both groups.|||
72479247|NCT00477334|144484713|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.01||||0.9372|TWO_SIDED|95.0|0.74|1.39|||Kaplan-Meier & Cox Regression||"Hazard ratio in time to healing=hazard rate of Famciclovir/hazard rate of Placebo.~Based on Cox proportional hazards model with treatment, pooled center and gender as explanatory variables."|Participants who discontinued from the study before healing of non-aborted lesions was confirmed and participants who completed the study after 21 days since treatment initiation without non-aborted lesion stages and without a final assessment on aborted lesion status were censored at the time of the last clinical lesion observation.||1.39|0.74|0.9372
72479248|NCT03486457|144484752|SUPERIORITY||Difference in percentage of participants|32.35|STANDARD_ERROR_OF_MEAN|5.05|<|0.0001|TWO_SIDED|95.0|22.45|42.25|||Normal approximation|||The normal approximation to the difference in binomial proportions was used to test the difference between tofacitinib 5 mg BID and placebo and to generate 95% CI and p-value for the difference in response rates.||42.25|22.45|<0.0001
72509284|NCT04467164|144548937|SUPERIORITY|||||||0.03|||||||ANCOVA|||The null hypothesis is that there were no differences in change of brain activity in the subgenual anterior cingulate cortex (fMRI BOLD signal) between exhalatory-gated and inhalatory-gated tVNS. An ANCOVA model was used with average beta weights in response to stress task at baseline as a covariate. The test was performed with a significance level of 0.05 (two-sided).||||0.03
72509285|NCT04467164|144548937|SUPERIORITY|||||||0.022|||||||ANCOVA|||The null hypothesis is that there were no differences in change of brain activity in the orbitofrontal cortex (fMRI BOLD signal) between exhalatory-gated and inhalatory-gated tVNS. An ANCOVA model was used with average beta weights in response to stress task at baseline as a covariate. The test was performed with a significance level of 0.05 (two-sided).||||0.022
72509286|NCT04467164|144548937|SUPERIORITY|||||||0.027|||||||ANCOVA|||The null hypothesis is that there were no differences in change of brain activity in the ventromedial prefrontal cortex (fMRI BOLD signal) between exhalatory-gated and inhalatory-gated tVNS. An ANCOVA model was used with average beta weights in response to stress task at baseline as a covariate. The test was performed with a significance level of 0.05 (two-sided).||||0.027
72509287|NCT04467164|144548938|SUPERIORITY|||||||0.03|||||||ANOVA|||Null hypothesis is that there was no difference in the change in BDI scale score between exhalatory-gated tVNS and inhalatory-gated tVNS. A repeated measures ANOVA controlled by baseline values was used to test this difference. A p\<0.05 was designated for statistical significance. A positive difference indicates an increase in depressive symptomatology, whereas a negative difference indicates a reduction in depressive symptoms.||||0.03
72509288|NCT04467164|144548939|SUPERIORITY|||||||0.01|||||||Regression, Linear|||The null hypothesis is that there were no differences in percent HFn changes post-pre stimulation between exhalatory-gated and inhalatory-gated tVNS. A General Linear Model (GLM) analysis adjusted by baseline values was used for evaluating differences in this measure between treatment groups. A p\<0.05 was designated for statistical significance. A positive percent change value indicates an increase in cardiovagal activity, whereas a negative change indicates a reduction in cardiovagal activity.||||0.01
72509289|NCT02369835|144548940|OTHER|||||||0.8872|||||||Chi-squared|||||||.8872
72509290|NCT01703286|144548947|SUPERIORITY_OR_OTHER||Geometric mean ratio (net)|0.884||||0.5403|TWO_SIDED|90.0|0.633|1.235|||ANOVA|||||1.235|0.633|0.5403
72509291|NCT01703286|144548947|SUPERIORITY_OR_OTHER||Geometric mean ratio (net)|0.884||||0.5402|TWO_SIDED|90.0|0.632|1.235|||ANOVA|||||1.235|0.632|0.5402
72509292|NCT01703286|144548947|SUPERIORITY_OR_OTHER||Geometric mean ratio (net)|1.0||||0.9989|TWO_SIDED|90.0|0.715|1.397|||ANOVA|||||1.397|0.715|0.9989
72509293|NCT01703286|144548948|SUPERIORITY_OR_OTHER||Geometric mean ratio (net)|1.208||||0.3885|TWO_SIDED|90.0|0.84|1.738|||ANOVA|||||1.738|0.840|0.3885
72509294|NCT01703286|144548948|SUPERIORITY_OR_OTHER||Geometric mean ratio (net)|1.251||||0.3105|TWO_SIDED|90.0|0.868|1.801|||ANOVA|||||1.801|0.868|0.3105
72509295|NCT01703286|144548948|SUPERIORITY_OR_OTHER||Geometric mean ratio (net)|1.035||||0.8749|TWO_SIDED|90.0|0.721|1.485|||ANOVA|||||1.485|0.721|0.8749
72509296|NCT01703286|144548949|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.05|STANDARD_ERROR_OF_MEAN|0.048||0.2982|TWO_SIDED|90.0|-0.13|0.03|||ANOVA|||||0.030|-0.130|0.2982
72509297|NCT01703286|144548949|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.021|STANDARD_ERROR_OF_MEAN|0.048||0.6601|TWO_SIDED|90.0|-0.059|0.101|||ANOVA|||||0.101|-0.059|0.6601
72479249|NCT03486457|144484753|SUPERIORITY||Difference in percentage of participants|15.44|STANDARD_ERROR_OF_MEAN|4.79||0.0013|TWO_SIDED|95.0|6.05|24.83|||Normal approximation|||Week 2: The normal approximation to the difference in binomial proportions was used to test the difference between the two treatment arms and to generate 95% CI and p-value for the difference in response rates.||24.83|6.05|0.0013
72479250|NCT03486457|144484753|SUPERIORITY||Difference in percentage of participants|30.15|STANDARD_ERROR_OF_MEAN|5.41|<|0.0001|TWO_SIDED|95.0|19.53|40.76|||Normal approximation|||Month 1: The normal approximation to the difference in binomial proportions was used to test the difference between the two treatment arms and to generate 95% CI and p-value for the difference in response rates.||40.76|19.53|<0.0001
72479251|NCT03486457|144484753|SUPERIORITY||Difference in percentage of participants|51.47|STANDARD_ERROR_OF_MEAN|5.56|<|0.0001|TWO_SIDED|95.0|40.57|62.37|||Normal approximation|||Month 2: The normal approximation to the difference in binomial proportions was used to test the difference between the two treatment arms and to generate 95% CI and p-value for the difference in response rates.||62.37|40.57|<0.0001
72479252|NCT03486457|144484753|SUPERIORITY||Difference in percentage of participants|36.76|STANDARD_ERROR_OF_MEAN|6.81|<|0.0001|TWO_SIDED|95.0|23.41|50.12|||Normal approximation|||Month 3: The normal approximation to the difference in binomial proportions was used to test the difference between the two treatment arms and to generate 95% CI and p-value for the difference in response rates.||50.12|23.41|<0.0001
72566567|NCT02985879|144663385|SUPERIORITY|The analysis utilized a likelihood-based, mixed-effects model, repeated measures (MMRM) analysis of the change from baseline for each postbaseline value and compared each ABBV-8E12 dose group with the placebo group. The model, which used all observed data, included fixed, categorical effects for treatment, site, visit, baseline score-by-visit interaction and treatment-by-visit interaction, with continuous fixed covariates for the corresponding baseline score.|LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.16|=|0.409|TWO_SIDED|95.0|-0.44|0.18|||Mixed-effects model, repeated measures||ABBV-8E12 4000 mg - Placebo|ABBV-8E12 4000 mg vs Placebo||0.18|-0.44|=0.409
72566568|NCT02985879|144663386|SUPERIORITY|The analysis utilized a likelihood-based, mixed-effects model, repeated measures (MMRM) analysis of the change from baseline for each postbaseline value and compared each ABBV-8E12 dose group with the placebo group. The model, which used all observed data, included fixed, categorical effects for treatment, site, visit, baseline score-by-visit interaction and treatment-by-visit interaction, with continuous fixed covariates for the corresponding baseline score.|LS Mean Difference|-7.2|STANDARD_ERROR_OF_MEAN|13.54|=|0.597|TWO_SIDED|95.0|-33.86|19.53|||Mixed-effects model, repeated measures||ABBV-8E12 2000 mg - Placebo|ABBV-8E12 2000 mg vs Placebo||19.53|-33.86|=0.597
72566569|NCT02985879|144663386|SUPERIORITY|The analysis utilized a likelihood-based, mixed-effects model, repeated measures (MMRM) analysis of the change from baseline for each postbaseline value and compared each ABBV-8E12 dose group with the placebo group. The model, which used all observed data, included fixed, categorical effects for treatment, site, visit, baseline score-by-visit interaction and treatment-by-visit interaction, with continuous fixed covariates for the corresponding baseline score.|LS Mean Difference|-6.3|STANDARD_ERROR_OF_MEAN|13.56|=|0.642|TWO_SIDED|95.0|-33.04|20.42|||Mixed-effects model, repeated measures||ABBV-8E12 4000 mg - Placebo|ABBV-8E12 4000 mg vs Placebo||20.42|-33.04|=0.642
72576851|NCT00261443|144680662|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.12||||0.418|TWO_SIDED|95.0|-0.43|0.18||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 28 Comparison||0.18|-0.43|0.418
72576852|NCT00261443|144680662|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.2||||0.185|TWO_SIDED|95.0|-0.51|0.1||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 32 Comparison||0.10|-0.51|0.185
72576853|NCT00261443|144680662|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.1||||0.536|TWO_SIDED|95.0|-0.41|0.21||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 36 Comparison||0.21|-0.41|0.536
72479253|NCT03486457|144484753|SUPERIORITY||Difference in percentage of participants|24.26|STANDARD_ERROR_OF_MEAN|7.21||0.0008|TWO_SIDED|95.0|10.14|38.39|||Normal approximation|||Month 4: The normal approximation to the difference in binomial proportions was used to test the difference between the two treatment arms and to generate 95% CI and p-value for the difference in response rates.||38.39|10.14|0.0008
72509298|NCT01703286|144548949|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.072|STANDARD_ERROR_OF_MEAN|0.048||0.1412|TWO_SIDED|90.0|-0.009|0.152|||ANOVA|||||0.152|-0.009|0.1412
72509299|NCT01984346|144548951|SUPERIORITY||Mean Difference (Net)|16.7||||0.0472|TWO_SIDED|95.0|0.1|33.2||A prior threshold for statistical significance was 0.05|Chi-square test|||||33.2|0.1|0.0472
72509300|NCT00972244|144548979|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.47|STANDARD_ERROR_OF_MEAN|0.0987|<|0.0001|TWO_SIDED|95.0|-0.67|-0.28||significant at alpha=0.015 (2-sided) applying Dunnett's adjustment. A sequential closed testing procedure was used to control Type I error rate across the primary and key secondary endpoints.|ANCOVA|with treatment group (all treatment groups included) as fixed effect and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0 (with alpha = 0.015 applying Dunnett's adjustment, two-sided)||-0.28|-0.67|<0.0001
72509301|NCT00972244|144548979|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.45|STANDARD_ERROR_OF_MEAN|0.1009|<|0.0001|TWO_SIDED|95.0|-0.65|-0.26||significant at alpha=0.015 (2-sided) applying Dunnett's adjustment. A sequential closed testing procedure was used to control Type I error rate across the primary and key secondary endpoints.|ANCOVA|with treatment group (all treatment groups included) as fixed effect and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0 (with alpha = 0.015 applying Dunnett's adjustment, two-sided)||-0.26|-0.65|<0.0001
72400201|NCT01787175|144308179|SUPERIORITY_OR_OTHER||Difference in time to complete A&P|-17.73||||0.047|TWO_SIDED|95.0|-35.24|-0.23|||Mixed-effects linear model|||Null hypothesis: Participants will require the same amount of time to complete assessments and plans using either IMM or CPRS. Power calculation: With 2 replications per subject, and assuming an ICC of 0.15, a two-sided alpha 0.05 comparison adjusted for 5 multiple comparisons (adjusted alpha = 0.01), and power of 80%, an N of 32 clinicians was required for each group (32 using IMM, and 32 using CPRS).||-0.23|-35.24|0.047
72400202|NCT01787175|144308180|SUPERIORITY_OR_OTHER||Value of problem scores for A&P complete|0.04||||0.15|TWO_SIDED|95.0|-0.01|0.09|||Mixed-effects linear model|||Null hypothesis: Participants will receive the same scores for assessments and plans completed using either IMM or CPRS. Power calculation: With 2 replications per subject, and assuming an ICC of 0.15, a two-sided alpha 0.05 comparison adjusted for 5 multiple comparisons (adjusted alpha = 0.01), and power of 80%, an N of 32 clinicians was required for each group (32 using IMM, and 32 using CPRS).||0.09|-0.01|0.15
72566570|NCT02985879|144663387|SUPERIORITY|The analysis utilized a likelihood-based, mixed-effects model, repeated measures (MMRM) analysis of the change from baseline for each postbaseline value and compared each ABBV-8E12 dose group with the placebo group. The model, which used all observed data, included fixed, categorical effects for treatment, site, visit, baseline score-by-visit interaction and treatment-by-visit interaction, with continuous fixed covariates for the corresponding baseline score.|LS Mean Difference|2.5|STANDARD_ERROR_OF_MEAN|2.53|=|0.323|TWO_SIDED|95.0|-2.48|7.51|||Mixed-effects model, repeated measures||ABBV-8E12 2000 mg - Placebo|ABBV-8E12 2000 mg vs Placebo||7.51|-2.48|=0.323
72479254|NCT03486457|144484753|SUPERIORITY||Difference in percentage of participants|13.97|STANDARD_ERROR_OF_MEAN|7.08||0.0486|TWO_SIDED|95.0|0.09|27.85|||Normal approximation|||Month 6: The normal approximation to the difference in binomial proportions was used to test the difference between the two treatment arms and to generate 95% CI and p-value for the difference in response rates.||27.85|0.09|0.0486
72479255|NCT03486457|144484754|SUPERIORITY||Difference in percentage of participants|1.1|STANDARD_ERROR_OF_MEAN|1.53||0.473|TWO_SIDED|95.0|-1.9|4.1|||Normal approximation|||Week 2: The normal approximation to the difference in binomial proportions was used to test the difference between the two treatment arms and to generate 95% CI and p-value for the difference in response rates.||4.10|-1.90|0.4730
72479256|NCT03486457|144484754|SUPERIORITY||Difference in percentage of participants|1.83|STANDARD_ERROR_OF_MEAN|1.69||0.2792|TWO_SIDED|95.0|-1.48|5.14|||Normal approximation|||Month 1: The normal approximation to the difference in binomial proportions was used to test the difference between the two treatment arms and to generate 95% CI and p-value for the difference in response rates.||5.14|-1.48|0.2792
72479257|NCT03486457|144484754|SUPERIORITY||Difference in percentage of participants|7.35|STANDARD_ERROR_OF_MEAN|2.84||0.0095|TWO_SIDED|95.0|1.79|12.91|||Normal approximation|||Month 2: The normal approximation to the difference in binomial proportions was used to test the difference between the two treatment arms and to generate 95% CI and p-value for the difference in response rates.||12.91|1.79|0.0095
72479258|NCT03486457|144484754|SUPERIORITY||Difference in percentage of participants|13.24|STANDARD_ERROR_OF_MEAN|3.37|<|0.0001|TWO_SIDED|95.0|6.63|19.84|||Normal approximation|||Month 3: The normal approximation to the difference in binomial proportions was used to test the difference between the two treatment arms and to generate 95% CI and p-value for the difference in response rates.||19.84|6.63|<0.0001
72479259|NCT03486457|144484754|SUPERIORITY||Difference in percentage of participants|13.24|STANDARD_ERROR_OF_MEAN|4.69||0.0048|TWO_SIDED|95.0|4.03|22.44|||Normal approximation|||Month 4: The normal approximation to the difference in binomial proportions was used to test the difference between the two treatment arms and to generate 95% CI and p-value for the difference in response rates.||22.44|4.03|0.0048
72479260|NCT03486457|144484754|SUPERIORITY||Difference in percentage of participants|13.24|STANDARD_ERROR_OF_MEAN|6.6||0.0449|TWO_SIDED|95.0|0.3|26.17|||Normal approximation|||Month 6: The normal approximation to the difference in binomial proportions was used to test the difference between the two treatment arms and to generate 95% CI and p-value for the difference in response rates.||26.17|0.30|0.0449
72479261|NCT03486457|144484755|SUPERIORITY||Difference in percentage of participants|2.94|STANDARD_ERROR_OF_MEAN|2.29||0.1985|TWO_SIDED|95.0|-1.54|7.42|||Normal approximation|||Week 2: The normal approximation to the difference in binomial proportions was used to test the difference between the two treatment arms and to generate 95% CI and p-value for the difference in response rates.||7.42|-1.54|0.1985
72479262|NCT03486457|144484755|SUPERIORITY||Difference in percentage of participants|8.09|STANDARD_ERROR_OF_MEAN|2.91||0.0055|TWO_SIDED|95.0|2.38|13.8|||Normal approximation|||Month 1: The normal approximation to the difference in binomial proportions was used to test the difference between the two treatment arms and to generate 95% CI and p-value for the difference in response rates.||13.80|2.38|0.0055
72479263|NCT03486457|144484755|SUPERIORITY||Difference in percentage of participants|27.21|STANDARD_ERROR_OF_MEAN|4.44|<|0.0001|TWO_SIDED|95.0|18.51|35.9|||Normal approximation|||Month 2: The normal approximation to the difference in binomial proportions was used to test the difference between the two treatment arms and to generate 95% CI and p-value for the difference in response rates.||35.90|18.51|<0.0001
72479264|NCT03486457|144484755|SUPERIORITY||Difference in percentage of participants|22.06|STANDARD_ERROR_OF_MEAN|6.37||0.0005|TWO_SIDED|95.0|9.58|34.54|||Normal approximation|||Month 4: The normal approximation to the difference in binomial proportions was used to test the difference between the two treatment arms and to generate 95% CI and p-value for the difference in response rates.||34.54|9.58|0.0005
72479265|NCT03486457|144484755|SUPERIORITY||Difference in percentage of participants|18.38|STANDARD_ERROR_OF_MEAN|7.24||0.0111|TWO_SIDED|95.0|4.2|32.57|||Normal approximation|||Month 6: The normal approximation to the difference in binomial proportions was used to test the difference between the two treatment arms and to generate 95% CI and p-value for the difference in response rates.||32.57|4.20|0.0111
72479266|NCT03486457|144484756|SUPERIORITY||LS mean difference|-0.11|STANDARD_ERROR_OF_MEAN|0.044||0.0097|TWO_SIDED|95.0|-0.2|-0.03|||Mixed Models Analysis|||Week 2: Analysis performed using mixed model for repeated measures (MMRM) which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-0.03|-0.20|0.0097
72400203|NCT01787175|144308181|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.9||||0.005|TWO_SIDED|95.0|1.22|2.98|||Regression, Logistic|||Null hypothesis: Participants will receive the same proportion of acceptable scores for assessments and plans completed using either IMM or CPRS. Power calculation: With 2 replications per subject, and assuming an ICC of 0.15, a two-sided alpha 0.05 comparison adjusted for 5 multiple comparisons (adjusted alpha = 0.01), and power of 80%, an N of 32 clinicians was required for each group (32 using IMM, and 32 using CPRS).||2.98|1.22|0.005
72400204|NCT00827983|144308182|NON_INFERIORITY_OR_EQUIVALENCE|The null hypothesis (H0) was tested against the alternative by calculating a two-sided 95% confidence interval for the difference in ongoing pregnancy rates. If the lower bound of the 95% confidence interval was greater than the non-inferiority limit (-10.0%), the null hypothesis was rejected and the test group considered not inferior to the control treatment.|Difference in pregnancy rates|-3.1||||0.37|TWO_SIDED|95.0|-9.9|3.7|||Chi-squared|||"The non -inferiority hypothesis to be tested for the primary endpoint was that the ongoing pregnancy rate (oPR) in the test group (Pe)was lower than the oPR in the control group (Pc)against the alternative one that the oPR in the test group was equal to or higher than the oPR in the control group.~H0 : Pc\>= Pe + d(-10%) H1 : Pc\< Pe + d(-10%)"||3.7|-9.9|0.37
72400205|NCT00827983|144308183|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-3.1||||0.37|TWO_SIDED|95.0|-9.87|3.68|||Chi-squared|||||3.68|-9.87|0.37
72400206|NCT00827983|144308184|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|1.33||0.85|TWO_SIDED|95.0|-4.7|5.8|||t-test, 2 sided|||||5.8|-4.7|0.85
72400207|NCT02113956|144308186|SUPERIORITY||Incident Rate Ratio (IRR)|1.42|||||TWO_SIDED|95.0|0.79|2.57|||Poisson regression||Adjusted for age and baseline number of condomless sex acts|||2.57|0.79|
72400208|NCT02113956|144308187|SUPERIORITY||Odds Ratio (OR)|0.63|||||TWO_SIDED|95.0|0.36|1.12|||Regression, Logistic||||Adjusted for age and baseline rate of abstinence|1.12|0.36|
72400209|NCT02113956|144308188|SUPERIORITY||Incident Rate Ratio|0.95|||||TWO_SIDED|95.0|0.45|2.02|||Poisson||||Adjusted for age and baseline number of condomless sex acts|2.02|0.45|
72400210|NCT02113956|144308189|SUPERIORITY||Incident Rate Ratio (IRR)|0.62|||||TWO_SIDED|95.0|0.12|3.18|||Poisson||||Adjusted for age and baseline number of condomless sex acts|3.18|0.12|
72400211|NCT02113956|144308190|SUPERIORITY||Odds Ratio (OR)|0.48|||||TWO_SIDED|95.0|0.23|0.997|||Regression, Logistic||||Adjusted for age and baseline rate of abstinence|0.997|0.23|
72400212|NCT02113956|144308191|SUPERIORITY||Odds Ratio (OR)|0.98|||||TWO_SIDED|95.0|0.38|2.53|||Regression, Logistic||||Adjusted for age and baseline rate of abstinence|2.53|0.38|
72479267|NCT03486457|144484756|SUPERIORITY||LS mean difference|-0.13|STANDARD_ERROR_OF_MEAN|0.045||0.0043|TWO_SIDED|95.0|-0.22|-0.04|||Mixed Models Analysis|||Month 1: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-0.04|-0.22|0.0043
72479268|NCT03486457|144484756|SUPERIORITY||LS mean difference|-0.21|STANDARD_ERROR_OF_MEAN|0.048|<|0.0001|TWO_SIDED|95.0|-0.3|-0.11|||Mixed Models Analysis|||Month 2: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-0.11|-0.30|<0.0001
72479269|NCT03486457|144484756|SUPERIORITY||LS mean difference|-0.22|STANDARD_ERROR_OF_MEAN|0.053|<|0.0001|TWO_SIDED|95.0|-0.32|-0.11|||Mixed Models Analysis|||Month 3: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-0.11|-0.32|<0.0001
72479270|NCT03486457|144484756|SUPERIORITY||LS mean difference|-0.09|STANDARD_ERROR_OF_MEAN|0.046||0.0535|TWO_SIDED|95.0|-0.18|0.0|||Mixed Models Analysis|||Month 4: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||0.00|-0.18|0.0535
72479271|NCT03486457|144484756|SUPERIORITY||LS mean difference|-0.07|STANDARD_ERROR_OF_MEAN|0.044||0.094|TWO_SIDED|95.0|-0.16|0.01|||Mixed Models Analysis|||Month 6: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||0.01|-0.16|0.0940
72479272|NCT03486457|144484757|SUPERIORITY||Difference in percentage of participants|13.07|STANDARD_ERROR_OF_MEAN|8.56||0.127|TWO_SIDED|95.0|-3.72|29.85|||Normal approximation|||Week 2: The normal approximation to the difference in binomial proportions was used to test the difference between the two treatment arms and to generate 95% CI and p-value for the difference in response rates.||29.85|-3.72|0.1270
72400213|NCT02113956|144308192|SUPERIORITY||Odds Ratio (OR)|3.42|||||TWO_SIDED|95.0|1.65|7.09|||Regression, Logistic||||Adjusted for age and baseline rate of HIV testing|7.09|1.65|
72400214|NCT02113956|144308193|SUPERIORITY||Incident Risk Ratio (IRR)|0.58|||||TWO_SIDED|95.0|0.22|1.5|||Poisson||||Adjusted for age and baseline number of condomless sex acts|1.5|0.22|
72400215|NCT02113956|144308194|SUPERIORITY||Odds Ratio (OR)|1.12|||||TWO_SIDED|95.0|0.6|2.09|||Regression, Logistic||||Adjusted for age and baseline rate of abstinence|2.09|0.6|
72400216|NCT02113956|144308195|SUPERIORITY||Incident Rate Ratio (IRR)|0.6|||||TWO_SIDED|95.0|0.22|1.68|||||||Adjusted for age and baseline number of condomless sex acts|1.68|0.22|
72400217|NCT02113956|144308196|SUPERIORITY||Incident Rate Ratio (IRR)|1.1|||||TWO_SIDED|95.0|0.01|92.03|||||||Adjusted for age and baseline number of condomless sex acts|92.03|0.01|
72400218|NCT02113956|144308197|SUPERIORITY||Odds Ratio (OR)|0.93|||||TWO_SIDED|95.0|0.46|1.88|||Regression, Logistic||||Adjusted for age and baseline rate of abstinence|1.88|0.46|
72400219|NCT02113956|144308198|SUPERIORITY||Odds Ratio (OR)|3.4|||||TWO_SIDED|95.0|0.88|16.95|||Regression, Logistic||||Adjusted for age and baseline rate of abstinence|16.95|0.88|
72400220|NCT02113956|144308199|SUPERIORITY||Odds Ratio (OR)|3.39|||||TWO_SIDED|95.0|1.52|7.58|||Regression, Logistic||||Adjusted for age and baseline rate of HIV testing|7.58|1.52|
72400221|NCT02117999|144308228|NON_INFERIORITY|Sample size calculation was performed to detect a difference of 0.95 D between the average Kmax changes for the T-ionto CL and standard CL groups at 12 months, at a significance level of 5% and a power of 81%, assuming a standard deviation of 1.20 D.|||||<|0.05|||||||ANOVA|||Analysis of changes from baseline in each group was made using the paired Student t-test. Treatment effects were assessed using repeated measures ANOVA between groups and time (3 days, 7 days, 1-, 3-, 6- and 12-months). The outcome measures over time were corrected for baseline values. The relationship between the change in Kmax at 12 months and baseline parameters was assessed using Pearson's correlation analysis for either group.||||<0.05
72479273|NCT03486457|144484757|SUPERIORITY||Difference in percentage of participants|4.02|STANDARD_ERROR_OF_MEAN|9.23||0.6634|TWO_SIDED|95.0|-14.07|22.1|||Normal approximation|||Month 1: The normal approximation to the difference in binomial proportions was used to test the difference between the two treatment arms and to generate 95% CI and p-value for the difference in response rates.||22.10|-14.07|0.6634
72479274|NCT03486457|144484757|SUPERIORITY||Difference in percentage of participants|21.78|STANDARD_ERROR_OF_MEAN|9.46||0.0214|TWO_SIDED|95.0|3.23|40.33|||Normal approximation|||Month 2: The normal approximation to the difference in binomial proportions was used to test the difference between the two treatment arms and to generate 95% CI and p-value for the difference in response rates.||40.33|3.23|0.0214
72479275|NCT03486457|144484757|SUPERIORITY||Difference in percentage of participants|24.03|STANDARD_ERROR_OF_MEAN|9.46||0.011|TWO_SIDED|95.0|5.5|42.57|||Normal approximation|||Month 3: The normal approximation to the difference in binomial proportions was used to test the difference between the two treatment arms and to generate 95% CI and p-value for the difference in response rates.||42.57|5.50|0.0110
72479276|NCT03486457|144484757|SUPERIORITY||Difference in percentage of participants|12.57|STANDARD_ERROR_OF_MEAN|9.58||0.1896|TWO_SIDED|95.0|-6.21|31.36|||Normal approximation|||Month 4: The normal approximation to the difference in binomial proportions was used to test the difference between the two treatment arms and to generate 95% CI and p-value for the difference in response rates.||31.36|-6.21|0.1896
72479277|NCT03486457|144484757|SUPERIORITY||Difference in percentage of participants|6.83|STANDARD_ERROR_OF_MEAN|8.97||0.4466|TWO_SIDED|95.0|-10.75|24.41|||Normal approximation|||Month 6: The normal approximation to the difference in binomial proportions was used to test the difference between the two treatment arms and to generate 95% CI and p-value for the difference in response rates.||24.41|-10.75|0.4466
72479278|NCT03486457|144484758|SUPERIORITY||Difference in percentage of participants|13.07|STANDARD_ERROR_OF_MEAN|8.56||0.127|TWO_SIDED|95.0|-3.72|29.85|||Normal approximation|||Week 2: The normal approximation to the difference in binomial proportions was used to test the difference between the two treatment arms and to generate 95% CI and p-value for the difference in response rates.||29.85|-3.72|0.1270
72479279|NCT03486457|144484758|SUPERIORITY||Difference in percentage of participants|4.02|STANDARD_ERROR_OF_MEAN|9.23||0.6634|TWO_SIDED|95.0|-14.07|22.1|||Normal approximation|||Month 1: The normal approximation to the difference in binomial proportions was used to test the difference between the two treatment arms and to generate 95% CI and p-value for the difference in response rates.||22.10|-14.07|0.6634
72479280|NCT03486457|144484758|SUPERIORITY||Difference in percentage of participants|21.78|STANDARD_ERROR_OF_MEAN|9.46||0.0214|TWO_SIDED|95.0|3.23|40.33|||Normal approximation|||Month 2: The normal approximation to the difference in binomial proportions was used to test the difference between the two treatment arms and to generate 95% CI and p-value for the difference in response rates.||40.33|3.23|0.0214
72479281|NCT03486457|144484758|SUPERIORITY||Difference in percentage of participants|24.03|STANDARD_ERROR_OF_MEAN|9.46||0.011|TWO_SIDED|95.0|5.5|42.57|||Normal approximation|||Month 3: The normal approximation to the difference in binomial proportions was used to test the difference between the two treatment arms and to generate 95% CI and p-value for the difference in response rates.||42.57|5.50|0.0110
72479282|NCT03486457|144484758|SUPERIORITY||Difference in percentage of participants|12.57|STANDARD_ERROR_OF_MEAN|9.58||0.1896|TWO_SIDED|95.0|-6.21|31.36|||Normal approximation|||Month 4: The normal approximation to the difference in binomial proportions was used to test the difference between the two treatment arms and to generate 95% CI and p-value for the difference in response rates.||31.36|-6.21|0.1896
72479283|NCT03486457|144484758|SUPERIORITY||Difference in percentage of participants|6.83|STANDARD_ERROR_OF_MEAN|8.97||0.4466|TWO_SIDED|95.0|-10.75|24.41|||Normal approximation|||Month 6: The normal approximation to the difference in binomial proportions was used to test the difference between the two treatment arms and to generate 95% CI and p-value for the difference in response rates.||24.41|-10.75|0.4466
72479284|NCT03486457|144484759|SUPERIORITY||LS mean difference|-2.7|STANDARD_ERROR_OF_MEAN|0.633|<|0.0001|TWO_SIDED|95.0|-3.95|-1.45|||Mixed Models Analysis|||Week 2: Analysis performed using mixed model for repeated measures (MMRM) which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-1.45|-3.95|<0.0001
72479285|NCT03486457|144484759|SUPERIORITY||LS mean difference|-3.79|STANDARD_ERROR_OF_MEAN|0.711|<|0.0001|TWO_SIDED|95.0|-5.2|-2.39|||Mixed Models Analysis|||Month 1: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-2.39|-5.20|<0.0001
72479286|NCT03486457|144484759|SUPERIORITY||LS mean difference|-4.89|STANDARD_ERROR_OF_MEAN|0.76|<|0.0001|TWO_SIDED|95.0|-6.39|-3.39|||Mixed Models Analysis|||Month 2: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-3.39|-6.39|<0.0001
72479287|NCT03486457|144484759|SUPERIORITY||LS mean difference|-5.85|STANDARD_ERROR_OF_MEAN|0.852|<|0.0001|TWO_SIDED|95.0|-7.53|-4.17|||Mixed Models Analysis|||Month 3: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-4.17|-7.53|<0.0001
72479288|NCT03486457|144484759|SUPERIORITY||LS mean difference|-3.2|STANDARD_ERROR_OF_MEAN|0.583|<|0.0001|TWO_SIDED|95.0|-4.35|-2.04|||Mixed Models Analysis|||Month 4: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-2.04|-4.35|<0.0001
72479289|NCT03486457|144484759|SUPERIORITY||LS mean difference|-2.59|STANDARD_ERROR_OF_MEAN|0.668||0.0002|TWO_SIDED|95.0|-3.91|-1.27|||Mixed Models Analysis|||Month 6: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-1.27|-3.91|0.0002
72479290|NCT03486457|144484760|SUPERIORITY||LS mean difference|-3.4|STANDARD_ERROR_OF_MEAN|1.012||0.001|TWO_SIDED|95.0|-5.4|-1.4|||Mixed Models Analysis|||Week 2: Analysis performed using mixed model for repeated measures (MMRM) which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-1.40|-5.40|0.0010
72479291|NCT03486457|144484760|SUPERIORITY||LS mean difference|-5.03|STANDARD_ERROR_OF_MEAN|1.024|<|0.0001|TWO_SIDED|95.0|-7.05|-3.01|||Mixed Models Analysis|||Month 1: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-3.01|-7.05|<0.0001
72400222|NCT02117999|144308229|NON_INFERIORITY|sample size calculation was performed to detect a difference of 0.95 D between the average Kmax changes for the T-ionto CL and standard CL groups at 12 months, at a significance level of 5% and a power of 81%, assuming a standard deviation of 1.20 D. The sample size of the study was 34 cases (allocation ratio of 2:1)|Mean Difference (Final Values)|35.0||||0.05|TWO_SIDED||||||ANOVA|||Analysis of changes from baseline in each group was made using the paired Student t-test. Treatment effects were assessed using repeated measures ANOVA between groups and time (3 days, 7 days, 1-, 3-, 6- and 12-months). The outcome measures over time were corrected for baseline values.||||0.05
72400223|NCT02496533|144308241|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.8|||<|0.001|TWO_SIDED|||||No multiple comparisons were conducted in this analysis. P-value not adjusted for multiple comparisons. No interim analyses performed.|ANOVA|||H0: No difference in reported anxiety as self-reported change of VAS between Baseline and After Imaging time points between the Massage and No Massage groups After Imaging.||||<0.001
72400224|NCT02496533|144308242|SUPERIORITY_OR_OTHER||||||<|0.02||||||No multiple comparisons were conducted in this analysis. P-value not adjusted for multiple comparisons. No interim analyses performed.|ANOVA|||H0: No difference in reported systolic blood pressure measurements between Baseline and After Imaging time points between the Massage and No Massage groups After Imaging.||||<0.02
72400225|NCT02496533|144308242|SUPERIORITY_OR_OTHER||||||<|0.09||||||No multiple comparisons were conducted in this analysis. P-Value not adjusted for multiple comparisons. No interim analyses were performed.|ANOVA|||H0: No difference in reported diastolic blood pressure between Baseline and After Imaging time points between the Massage and No Massage groups After Imaging.||||<0.09
72400226|NCT02496533|144308243|SUPERIORITY_OR_OTHER||||||<|0.009||||||No multiple comparisons were conducted in this analysis. P-value not adjusted for multiple comparisons. No interim analyses performed.|ANOVA|||H0: No difference in reported respiration rate between Baseline and After Imaging time points between the Massage and No Massage groups After Imaging.||||<0.009
72400227|NCT02496533|144308244|SUPERIORITY_OR_OTHER||||||<|0.45||||||No multiple comparisons were conducted in this analysis. P-value not adjusted for multiple comparisons. No interim analyses performed.|ANOVA|||H0: No difference in reported pulse rate between Baseline and After Imaging time points between the Massage and No Massage groups After Imaging.||||<0.45
72400228|NCT02016625|144308265|NON_INFERIORITY_OR_EQUIVALENCE|Null hypothesis (H0): ratio is outside of interval (80%, 125%) vs. alternative hypothesis (H1): ratio is inside of interval (80%, 125%)|gMean ratio (%)|108.2|STANDARD_ERROR_OF_MEAN|11.5||0.0033|TWO_SIDED|90.0|99.992|117.076|||ANOVA||ratio of cyclo + FDV to cyclo treatment. The standard error of the mean actually is the geometric coefficient of variation (%).|Geometric mean (gMean) ratio of cyclo + FDV to cyclo treatment. The statistical model used for the analysis of primary endpoints was an analysis of variance (ANOVA) model on the logarithmic scale. This model accounted for variation from 'subject' and 'treatment' effects. The 'subject' effect was considered to be random, whereas the 'treatment' effect was considered as fixed.||117.076|99.992|0.0033
72400229|NCT02016625|144308266|NON_INFERIORITY_OR_EQUIVALENCE|H0: ratio is outside of interval (80%, 125%) vs. H1: ratio is inside of interval (80%, 125%)|gMean ratio (%)|106.6|STANDARD_ERROR_OF_MEAN|11.7||0.0019|TWO_SIDED|90.0|98.36|115.534|||ANOVA||gMean ratio of cyclo+FDV to cyclo treatment. The standard error of the mean actually is the geometric coefficient of variation (%).|gMean ratio of cyclo+FDV to cyclo treatment The statistical model used for the analysis of primary endpoints was an analysis of variance (ANOVA) model on the logarithmic scale. This model accounted for variation from 'subject' and 'treatment' effects. The 'subject' effect was considered to be random, whereas the 'treatment' effect was considered as fixed.||115.534|98.360|0.0019
72479292|NCT03486457|144484760|SUPERIORITY||LS mean difference|-5.68|STANDARD_ERROR_OF_MEAN|1.023|<|0.0001|TWO_SIDED|95.0|-7.7|-3.66|||Mixed Models Analysis|||Month 2: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-3.66|-7.70|<0.0001
72479293|NCT03486457|144484760|SUPERIORITY||LS mean difference|-7.01|STANDARD_ERROR_OF_MEAN|1.111|<|0.0001|TWO_SIDED|95.0|-9.2|-4.82|||Mixed Models Analysis|||Month 3: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-4.82|-9.20|<0.0001
72479294|NCT03486457|144484760|SUPERIORITY||LS mean difference|-3.95|STANDARD_ERROR_OF_MEAN|1.073||0.0003|TWO_SIDED|95.0|-6.07|-1.83|||Mixed Models Analysis|||Month 4: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-1.83|-6.07|0.0003
72479295|NCT03486457|144484760|SUPERIORITY||LS mean difference|-2.39|STANDARD_ERROR_OF_MEAN|1.108||0.0323|TWO_SIDED|95.0|-4.58|-0.2|||Mixed Models Analysis|||Month 6: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-0.20|-4.58|0.0323
72479296|NCT03486457|144484761|SUPERIORITY||LS mean difference|-6.57|STANDARD_ERROR_OF_MEAN|2.481||0.0087|TWO_SIDED|95.0|-11.46|-1.68|||Mixed Models Analysis|||Week 2: Analysis performed using mixed model for repeated measures (MMRM) which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-1.68|-11.46|0.0087
72479297|NCT03486457|144484761|SUPERIORITY||LS mean difference|-11.7|STANDARD_ERROR_OF_MEAN|2.487|<|0.0001|TWO_SIDED|95.0|-16.6|-6.79|||Mixed Models Analysis|||Month 1: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-6.79|-16.60|<0.0001
72479298|NCT03486457|144484761|SUPERIORITY||LS mean difference|-16.14|STANDARD_ERROR_OF_MEAN|2.796|<|0.0001|TWO_SIDED|95.0|-21.66|-10.63|||Mixed Models Analysis|||Month 2: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-10.63|-21.66|<0.0001
72479299|NCT03486457|144484761|SUPERIORITY||LS mean difference|-21.87|STANDARD_ERROR_OF_MEAN|3.027|<|0.0001|TWO_SIDED|95.0|-27.84|-15.9|||Mixed Models Analysis|||Month 3: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-15.90|-27.84|<0.0001
72479300|NCT03486457|144484761|SUPERIORITY||LS mean difference|-6.94|STANDARD_ERROR_OF_MEAN|2.865||0.0163|TWO_SIDED|95.0|-12.6|-1.29|||Mixed Models Analysis|||Month 4: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-1.29|-12.60|0.0163
72509302|NCT00972244|144548979|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.72|STANDARD_ERROR_OF_MEAN|0.099|<|0.0001|TWO_SIDED|95.0|-0.92|-0.53||significant at alpha=0.015 (2-sided) applying Dunnett's adjustment. A sequential closed testing procedure was used to control Type I error rate across the primary and key secondary endpoints.|ANCOVA|with treatment group (all treatment groups included) as fixed effect and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0 (with alpha = 0.015 applying Dunnett's adjustment, two-sided)||-0.53|-0.92|<0.0001
72479301|NCT03486457|144484761|SUPERIORITY||LS mean difference|-3.1|STANDARD_ERROR_OF_MEAN|2.967||0.2977|TWO_SIDED|95.0|-8.95|2.76|||Mixed Models Analysis|||Month 6: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||2.76|-8.95|0.2977
72509303|NCT00972244|144548979|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.79|STANDARD_ERROR_OF_MEAN|0.1018|<|0.0001|TWO_SIDED|95.0|-0.99|-0.59||significant at alpha=0.015 (2-sided) applying Dunnett's adjustment. A sequential closed testing procedure was used to control Type I error rate across the primary and key secondary endpoints.|ANCOVA|with treatment group (all treatment groups included) as fixed effect and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0 (with alpha = 0.015 applying Dunnett's adjustment, two-sided)||-0.59|-0.99|<0.0001
72509304|NCT00972244|144548980|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-26.08|STANDARD_ERROR_OF_MEAN|4.7589|<|0.0001|TWO_SIDED|95.0|-35.45|-16.7||significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a sequential closed testing procedure within treatment group.|ANCOVA|with treatment group (all treatment groups included) as fixed effect and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0||-16.70|-35.45|<0.0001
72479302|NCT03486457|144484762|SUPERIORITY||LS mean difference|-6.15|STANDARD_ERROR_OF_MEAN|2.646||0.0211|TWO_SIDED|95.0|-11.37|-0.93|||Mixed Models Analysis|||Week 2: Analysis performed using mixed model for repeated measures (MMRM) which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-0.93|-11.37|0.0211
72479303|NCT03486457|144484762|SUPERIORITY||LS mean difference|-13.08|STANDARD_ERROR_OF_MEAN|2.79|<|0.0001|TWO_SIDED|95.0|-18.59|-7.58|||Mixed Models Analysis|||Month 1: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-7.58|-18.59|<0.0001
72479304|NCT03486457|144484762|SUPERIORITY||LS mean difference|-13.16|STANDARD_ERROR_OF_MEAN|2.928|<|0.0001|TWO_SIDED|95.0|-18.93|-7.38|||Mixed Models Analysis|||Month 2: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-7.38|-18.93|<0.0001
72479305|NCT03486457|144484762|SUPERIORITY||LS mean difference|-18.77|STANDARD_ERROR_OF_MEAN|3.187|<|0.0001|TWO_SIDED|95.0|-25.06|-12.49|||Mixed Models Analysis|||Month 3: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-12.49|-25.06|<0.0001
72479306|NCT03486457|144484762|SUPERIORITY||LS mean difference|-7.01|STANDARD_ERROR_OF_MEAN|2.827||0.014|TWO_SIDED|95.0|-12.59|-1.43|||Mixed Models Analysis|||Month 4: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-1.43|-12.59|0.0140
72479307|NCT03486457|144484762|SUPERIORITY||LS mean difference|-5.14|STANDARD_ERROR_OF_MEAN|2.931||0.0811|TWO_SIDED|95.0|-10.93|0.64|||Mixed Models Analysis|||Month 6: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||0.64|-10.93|0.0811
72479308|NCT03486457|144484763|SUPERIORITY||LS mean difference|-9.64|STANDARD_ERROR_OF_MEAN|1.939|<|0.0001|TWO_SIDED|95.0|-13.46|-5.81|||Mixed Models Analysis|||Week 2: Analysis performed using mixed model for repeated measures (MMRM) which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-5.81|-13.46|<0.0001
72479309|NCT03486457|144484763|SUPERIORITY||LS mean difference|-9.52|STANDARD_ERROR_OF_MEAN|2.305|<|0.0001|TWO_SIDED|95.0|-14.07|-4.98|||Mixed Models Analysis|||Month 1: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-4.98|-14.07|<0.0001
72479310|NCT03486457|144484763|SUPERIORITY||LS mean difference|-16.97|STANDARD_ERROR_OF_MEAN|2.472|<|0.0001|TWO_SIDED|95.0|-21.85|-12.1|||Mixed Models Analysis|||Month 2: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-12.10|-21.85|<0.0001
72479311|NCT03486457|144484763|SUPERIORITY||LS mean difference|-18.42|STANDARD_ERROR_OF_MEAN|2.506|<|0.0001|TWO_SIDED|95.0|-23.36|-13.48|||Mixed Models Analysis|||Month 3: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-13.48|-23.36|<0.0001
72479312|NCT03486457|144484763|SUPERIORITY||LS mean difference|-7.22|STANDARD_ERROR_OF_MEAN|2.453||0.0037|TWO_SIDED|95.0|-12.06|-2.38|||Mixed Models Analysis|||Month 4: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-2.38|-12.06|0.0037
72479313|NCT03486457|144484763|SUPERIORITY||LS mean difference|-7.66|STANDARD_ERROR_OF_MEAN|2.267||0.0009|TWO_SIDED|95.0|-12.13|-3.18|||Mixed Models Analysis|||Month 6: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-3.18|-12.13|0.0009
72479314|NCT03486457|144484764|SUPERIORITY||LS mean difference|-7.2|STANDARD_ERROR_OF_MEAN|1.108|<|0.0001|TWO_SIDED|95.0|-9.39|-5.02|||Mixed Models Analysis|||Week 2: Analysis performed using mixed model for repeated measures (MMRM) which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-5.02|-9.39|<0.0001
72479315|NCT03486457|144484764|SUPERIORITY||LS mean difference|-7.87|STANDARD_ERROR_OF_MEAN|1.171|<|0.0001|TWO_SIDED|95.0|-10.18|-5.56|||Mixed Models Analysis|||Month 1: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-5.56|-10.18|<0.0001
72479316|NCT03486457|144484764|SUPERIORITY||LS mean difference|-7.41|STANDARD_ERROR_OF_MEAN|1.182|<|0.0001|TWO_SIDED|95.0|-9.74|-5.08|||Mixed Models Analysis|||Month 2: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-5.08|-9.74|<0.0001
72479317|NCT03486457|144484764|SUPERIORITY||LS mean difference|-7.8|STANDARD_ERROR_OF_MEAN|1.221|<|0.0001|TWO_SIDED|95.0|-10.21|-5.39|||Mixed Models Analysis|||Month 3: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-5.39|-10.21|<0.0001
72509305|NCT00972244|144548980|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-29.42|STANDARD_ERROR_OF_MEAN|4.71|<|0.0001|TWO_SIDED|95.0|-38.7|-20.14||significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a sequential closed testing procedure within treatment group.|ANCOVA|with treatment group (all treatment groups included) as fixed effect and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0||-20.14|-38.70|<0.0001
72509306|NCT00972244|144548980|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-32.94|STANDARD_ERROR_OF_MEAN|4.7402|<|0.0001|TWO_SIDED|95.0|-42.28|-23.6||significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a sequential closed testing procedure within treatment group.|ANCOVA|with treatment group (all treatment groups included) as fixed effect and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0||-23.60|-42.28|<0.0001
72509307|NCT00972244|144548980|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-41.37|STANDARD_ERROR_OF_MEAN|4.8358|<|0.0001|TWO_SIDED|95.0|-50.9|-31.85||significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a sequential closed testing procedure within treatment group.|ANCOVA|with treatment group (all treatment groups included) as fixed effect and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0||-31.85|-50.90|<0.0001
72566571|NCT02985879|144663387|SUPERIORITY|The analysis utilized a likelihood-based, mixed-effects model, repeated measures (MMRM) analysis of the change from baseline for each postbaseline value and compared each ABBV-8E12 dose group with the placebo group. The model, which used all observed data, included fixed, categorical effects for treatment, site, visit, baseline score-by-visit interaction and treatment-by-visit interaction, with continuous fixed covariates for the corresponding baseline score.|LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|2.51|=|0.974|TWO_SIDED|95.0|-4.86|5.02|||Mixed-effects model, repeated measures||ABBV-8E12 4000 mg - Placebo|ABBV-8E12 4000 mg vs Placebo||5.02|-4.86|=0.974
72623629|NCT00600340|144778098|NON_INFERIORITY|Null hypothesis: Hazard Ratio (HR) \>= 1.33 Based on Cox proportional hazards model.|Hazard Ratio (HR)|1.134||||0.0612|ONE_SIDED|97.5||1.386||Based on approach using repeated confidence intervals, with one-sided 97.5% repeated confidence intervals. Non-inferiority margin was a HR of 1.33.|Regression, Cox||HR is the hazard rate of Bevacizumab Plus Capecitabine divided by hazard rate of Bevacizumab plus Paclitaxel.|HR of Bevacizumab Plus Capecitabine vs. Bevacizumab plus Paclitaxel for OS (final, unstratified).||1.386||0.0612
72479318|NCT03486457|144484764|SUPERIORITY||LS mean difference|0.3|STANDARD_ERROR_OF_MEAN|0.615||0.6264|TWO_SIDED|95.0|-0.91|1.51|||Mixed Models Analysis|||Month 4: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||1.51|-0.91|0.6264
72509308|NCT00972244|144548981|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.2||||1|TWO_SIDED|95.0|-9.1|7.6||not significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a sequential closed testing procedure within treatment group.|Fisher Exact|||H0: proportion(treat) minus proportion(placebo) = 0 versus HA: proportion(treat) minus proportion(placebo) =/= 0||7.6|-9.1|1.0000
72509309|NCT00972244|144548981|SUPERIORITY_OR_OTHER||Risk Difference (RD)|7.3||||0.2057|TWO_SIDED|95.0|-2.3|18.8||not significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a sequential closed testing procedure within treatment group.|Fisher Exact|||H0: proportion(treat) minus proportion(placebo) = 0 versus HA: proportion(treat) minus proportion(placebo) =/= 0||18.8|-2.3|0.2057
72509310|NCT00972244|144548981|SUPERIORITY_OR_OTHER||Risk Difference (RD)|3.2||||0.6203|TWO_SIDED|95.0|-6.2|13.2||not significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a sequential closed testing procedure within treatment group.|Fisher Exact|||H0: proportion(treat) minus proportion(placebo) = 0 versus HA: proportion(treat) minus proportion(placebo) =/= 0||13.2|-6.2|0.6203
72400230|NCT02016625|144308267|NON_INFERIORITY_OR_EQUIVALENCE|H0: ratio is outside of interval (80%, 125%) VS H1: ratio is inside of interval (80%, 125%)|gMean ratio (%)|90.14|STANDARD_ERROR_OF_MEAN|16.6||0.0457|TWO_SIDED|90.0|80.281|101.205|||ANOVA||gMean ratio of cyclo+FDV to cyclo treatment. The standard error of the mean actually is the geometric coefficient of variation (%).|gMean ratio of cyclo+FDV to cyclo treatment The statistical model used for the analysis of primary endpoints was an analysis of variance (ANOVA) model on the logarithmic scale. This model accounted for variation from 'subject' and 'treatment' effects. The 'subject' effect was considered to be random, whereas the 'treatment' effect was considered as fixed.||101.205|80.281|0.0457
72400231|NCT02016625|144308268|NON_INFERIORITY_OR_EQUIVALENCE|H0: ratio is outside of interval (80%, 125%) VS H1: ratio is inside of interval (80%, 125%)|gMean ratio (%)|140.98|STANDARD_ERROR_OF_MEAN|35.8||0.8122|TWO_SIDED|90.0|111.772|177.833|||ANOVA||gMean ratio of cyclo+FDV to FDV treatment. The standard error of the mean actually is the geometric coefficient of variation (%).|gMean ratio of cyclo+FDV to FDV treatment. The statistical model used for the analysis of primary endpoints was an analysis of variance (ANOVA) model on the logarithmic scale. This model accounted for variation from 'subject' and 'treatment' effects. The 'subject' effect was considered to be random, whereas the 'treatment' effect was considered as fixed.||177.833|111.772|0.8122
72479319|NCT03486457|144484764|SUPERIORITY||LS mean difference|-1.29|STANDARD_ERROR_OF_MEAN|0.778||0.1008|TWO_SIDED|95.0|-2.82|0.25|||Mixed Models Analysis|||Month 6: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||0.25|-2.82|0.1008
72479320|NCT03486457|144484765|SUPERIORITY||Difference in percentage of participants|0.44|STANDARD_ERROR_OF_MEAN|1.77||0.8032|TWO_SIDED|95.0|-3.02|3.9|||Normal approximation|||Month 1: The normal approximation to the difference in binomial proportions was used to test the difference between the two treatment arms and to generate 95% CI and p-value for the difference in response rates.||3.90|-3.02|0.8032
72479321|NCT03486457|144484765|SUPERIORITY||Difference in percentage of participants|7.47|STANDARD_ERROR_OF_MEAN|3.44||0.0298|TWO_SIDED|95.0|0.73|14.21|||Normal approximation|||Month 3: The normal approximation to the difference in binomial proportions was used to test the difference between the two treatment arms and to generate 95% CI and p-value for the difference in response rates.||14.21|0.73|0.0298
72479322|NCT03486457|144484765|SUPERIORITY||Difference in percentage of participants|-11.19|STANDARD_ERROR_OF_MEAN|6.48||0.084|TWO_SIDED|95.0|-23.88|1.5|||Normal approximation|||Month 6: The normal approximation to the difference in binomial proportions was used to test the difference between the two treatment arms and to generate 95% CI and p-value for the difference in response rates.||1.50|-23.88|0.0840
72479323|NCT03486457|144484766|SUPERIORITY||LS mean difference|-0.35|STANDARD_ERROR_OF_MEAN|0.111||0.002|TWO_SIDED|95.0|-0.57|-0.13|||Mixed Models Analysis|||Month 1: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-0.13|-0.57|0.0020
72479324|NCT03486457|144484766|SUPERIORITY||LS mean difference|-0.59|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-0.87|-0.32|||Mixed Models Analysis|||Month 3: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-0.32|-0.87|<0.0001
72479325|NCT03486457|144484766|SUPERIORITY||LS mean difference|0.01|STANDARD_ERROR_OF_MEAN|0.156||0.9678|TWO_SIDED|95.0|-0.3|0.31|||Mixed Models Analysis|||Month 6: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||0.31|-0.30|0.9678
72479326|NCT03486457|144484767|SUPERIORITY||Difference in percentage of participants|14.96|STANDARD_ERROR_OF_MEAN|5.78||0.0097|TWO_SIDED|95.0|3.63|26.3|||Normal approximation|||Month 1: The normal approximation to the difference in binomial proportions was used to test the difference between the two treatment arms and to generate 95% CI and p-value for the difference in response rates.||26.30|3.63|0.0097
72479327|NCT03486457|144484767|SUPERIORITY||Difference in percentage of participants|24.89|STANDARD_ERROR_OF_MEAN|8.2||0.0024|TWO_SIDED|95.0|8.81|40.97|||Normal approximation|||Month 3: The normal approximation to the difference in binomial proportions was used to test the difference between the two treatment arms and to generate 95% CI and p-value for the difference in response rates.||40.97|8.81|0.0024
72479328|NCT03486457|144484767|SUPERIORITY||Difference in percentage of participants|-17.93|STANDARD_ERROR_OF_MEAN|11.03||0.1042|TWO_SIDED|95.0|-39.55|3.7|||Normal approximation|||Month 6: The normal approximation to the difference in binomial proportions was used to test the difference between the two treatment arms and to generate 95% CI and p-value for the difference in response rates.||3.70|-39.55|0.1042
72479329|NCT03486457|144484768|SUPERIORITY||LS mean difference|-25.89|STANDARD_ERROR_OF_MEAN|7.858||0.0014|TWO_SIDED|95.0|-41.49|-10.29|||Mixed Models Analysis|||Month 1: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-10.29|-41.49|0.0014
72479330|NCT03486457|144484768|SUPERIORITY||LS mean difference|-34.91|STANDARD_ERROR_OF_MEAN|8.948||0.0002|TWO_SIDED|95.0|-52.69|-17.13|||Mixed Models Analysis|||Month 3: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-17.13|-52.69|0.0002
72479331|NCT03486457|144484768|SUPERIORITY||LS mean difference|5.31|STANDARD_ERROR_OF_MEAN|10.663||0.62|TWO_SIDED|95.0|-15.9|26.51|||Mixed Models Analysis|||Month 6: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||26.51|-15.90|0.6200
72479332|NCT03486457|144484769|SUPERIORITY||LS mean difference|-39.65|STANDARD_ERROR_OF_MEAN|10.862||0.0004|TWO_SIDED|95.0|-61.21|-18.08|||Mixed Models Analysis|||Month 1, Erythema: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-18.08|-61.21|0.0004
72479333|NCT03486457|144484769|SUPERIORITY||LS mean difference|-25.18|STANDARD_ERROR_OF_MEAN|8.453||0.0037|TWO_SIDED|95.0|-41.97|-8.4|||Mixed Models Analysis|||Month 1, Induration: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-8.40|-41.97|0.0037
72479334|NCT03486457|144484769|SUPERIORITY||LS mean difference|-21.3|STANDARD_ERROR_OF_MEAN|10.423||0.0438|TWO_SIDED|95.0|-42.0|-0.61|||Mixed Models Analysis|||Month 1, Scaling: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-0.61|-42.00|0.0438
72479335|NCT03486457|144484769|SUPERIORITY||LS mean difference|-49.11|STANDARD_ERROR_OF_MEAN|10.529|<|0.0001|TWO_SIDED|95.0|-70.03|-28.19|||Mixed Models Analysis|||Month 3, Erythema: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-28.19|-70.03|<0.0001
72479336|NCT03486457|144484769|SUPERIORITY||LS mean difference|-29.71|STANDARD_ERROR_OF_MEAN|9.47||0.0023|TWO_SIDED|95.0|-48.52|-10.89|||Mixed Models Analysis|||Month 3, Induration: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-10.89|-48.52|0.0023
72509311|NCT00972244|144548981|SUPERIORITY_OR_OTHER||Risk Difference (RD)|7.7||||0.205|TWO_SIDED|95.0|-2.0|19.5||not significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a sequential closed testing procedure within treatment group.|Fisher Exact|||H0: proportion(treat) minus proportion(placebo) = 0 versus HA: proportion(treat) minus proportion(placebo) =/= 0||19.5|-2.0|0.2050
72509312|NCT03480282|144548985|OTHER|Because the observations were matched by the patient, we used the Wilcoxon signed-rank test, a nonparametric paired test|Mean Difference (Final Values)|2.5|||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||This was a descriptive feasibility study.|This was an exploratory and descriptive study to learn if it was feasible to provide PCPs with their patients (aged 76-89) with information about their 10-year prognosis and engage in shared decision making around stopping screening. We measured among the 90 patients that the 45 PCPs saw whether their intentions to be screened declined after seeing their PCP.|This was a descriptive feasibility study.|||<0.001
72509313|NCT03480282|144548985|OTHER|This was a descriptive feasibility study.|Risk Difference (RD)|0.05|||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||This was a descriptive feasibility study.|Because the observations were matched by the patient, we used the Wilcoxon signed-rank test, a nonparametric paired test|||<0.001
72509314|NCT05761444|144549004|OTHER||Least Squares (LS) mean difference|-21.22|||<|0.0001|TWO_SIDED|95.0|-29.26|-13.19||The analysis of covariance (ANCOVA) model with treatment group (ezetimibe/atorvastatin, atorvastatin) and history of statin administration (yes, no) as fixed effects and baseline LDL-C as a covariate.|ANCOVA|||||-13.19|-29.26|<0.0001
72509315|NCT05761444|144549007|OTHER||LS mean difference|-15.96|||<|0.0001|TWO_SIDED|95.0|-23.56|-8.36||The ANCOVA model with treatment group (ezetimibe/atorvastatin, atorvastatin) and history of statin administration (yes, no) as fixed effects and baseline LDL-C as a covariate.|ANCOVA|||||-8.36|-23.56|<0.0001
72479337|NCT03486457|144484769|SUPERIORITY||LS mean difference|-36.78|STANDARD_ERROR_OF_MEAN|10.72||0.0009|TWO_SIDED|95.0|-58.08|-15.49|||Mixed Models Analysis|||Month 3, Scaling: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-15.49|-58.08|0.0009
72479338|NCT03486457|144484769|SUPERIORITY||LS mean difference|7.03|STANDARD_ERROR_OF_MEAN|10.495||0.5048|TWO_SIDED|95.0|-13.84|27.9|||Mixed Models Analysis|||Month 6, Erythema: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||27.90|-13.84|0.5048
72509316|NCT00968253|144549088|SUPERIORITY_OR_OTHER||Maximum tolerated dose|5.0|||||TWO_SIDED||||||||Maximum tolerated dose (MTD) of Everolimus measured in mg/day in combination with HyperCVAD|||||
72509317|NCT03596177|144549091|SUPERIORITY||Mean Difference (Net)|-2.58||||0.011|TWO_SIDED|90.0|-4.15|-1.0|||ANCOVA|||||-1.00|-4.15|0.011
72509318|NCT03596177|144549092|SUPERIORITY||Mean Difference (Net)|-45.481||||0.002|TWO_SIDED|90.0|-67.777|-23.186|||ANCOVA|||Statistical Analysis for Day 32||-23.186|-67.777|0.002
72509319|NCT03596177|144549092|SUPERIORITY||Mean Difference (Net)|-41.323||||0.011|TWO_SIDED|90.0|-66.74|-15.907|||ANCOVA|||Statistical Analysis for Day 59||-15.907|-66.740|0.011
72509320|NCT03596177|144549093|SUPERIORITY||Mean Difference (Net)|-1551.194|||<|0.001|TWO_SIDED|90.0|-2190.515|-911.873|||ANCOVA|||Statistical Analysis for Day 32||-911.873|-2190.515|<0.001
72509321|NCT03596177|144549093|SUPERIORITY||Mean Difference (Net)|-1332.515||||0.015|TWO_SIDED|90.0|-2187.711|-477.318|||ANCOVA|||Statistical Analysis for Day 59||-477.318|-2187.711|0.015
72509322|NCT03596177|144549094|SUPERIORITY||Mean Difference (Net)|-3.173||||0.384|TWO_SIDED|90.0|-9.368|3.022|||ANCOVA|||||3.022|-9.368|0.384
72509323|NCT03596177|144549095|SUPERIORITY||Mean Difference (Net)|-10.039||||0.351|TWO_SIDED|90.0|-28.287|8.209|||ANCOVA|||||8.209|-28.287|0.351
72509324|NCT03596177|144549096|SUPERIORITY||Mean Difference (Net)|0.186||||0.968|TWO_SIDED|90.0|-7.858|8.229|||ANCOVA|||||8.229|-7.858|0.968
72509325|NCT03596177|144549097|SUPERIORITY||Mean Difference (Net)|0.867||||0.58|TWO_SIDED|90.0|-1.81|3.545|||ANCOVA|||||3.545|-1.810|0.580
72509326|NCT03596177|144549098|SUPERIORITY||Mean Difference (Net)|-3.645||||0.324|TWO_SIDED|90.0|-9.894|2.603|||ANCOVA|||||2.603|-9.894|0.324
72509327|NCT03596177|144549099|SUPERIORITY||Mean Difference (Net)|-5.672||||0.412|TWO_SIDED|90.0|-17.415|6.072|||ANCOVA|||||6.072|-17.415|0.412
72509328|NCT03596177|144549100|SUPERIORITY||Mean Difference (Net)|7.357||||0.177|TWO_SIDED|90.0|-1.742|16.456|||ANCOVA|||||16.456|-1.742|0.177
72509329|NCT03596177|144549101|SUPERIORITY||Mean Difference (Net)|15.186||||0.168|TWO_SIDED|90.0|-3.151|33.523|||ANCOVA|||||33.523|-3.151|0.168
72509330|NCT03596177|144549102|SUPERIORITY||Mean Difference (Net)|-2.54||||0.009|TWO_SIDED|90.0|-4.05|-1.03|||ANCOVA|||||-1.03|-4.05|0.009
72509331|NCT03596177|144549103|SUPERIORITY||Mean Difference (Net)|-5.122||||0.107|TWO_SIDED|90.0|-10.364|0.119|||ANCOVA|||||0.119|-10.364|0.107
72509332|NCT03596177|144549104|SUPERIORITY||Mean Difference (Net)|-1.848||||0.085|TWO_SIDED|90.0|-3.605|-0.091|||ANCOVA|||||-0.091|-3.605|0.085
72509333|NCT03596177|144549105|SUPERIORITY||Mean Difference (Net)|-3.159||||0.204|TWO_SIDED|90.0|-7.326|1.007|||ANCOVA|||||1.007|-7.326|0.204
72509334|NCT03596177|144549106|SUPERIORITY||Mean Difference (Net)|-0.019||||0.145|TWO_SIDED|90.0|-0.041|0.003|||ANCOVA|||||0.003|-0.041|0.145
72509335|NCT03596177|144549107|SUPERIORITY||Mean Difference (Net)|-26.001||||0.001|TWO_SIDED|90.0|-37.801|-14.201|||ANCOVA|||||-14.201|-37.801|0.001
72509336|NCT03596177|144549108|SUPERIORITY||Mean Difference (Net)|-12.332||||0.01|TWO_SIDED|90.0|-19.726|-4.938|||ANCOVA|||||-4.938|-19.726|0.010
72566572|NCT02985879|144663392|SUPERIORITY|The analysis utilized a likelihood-based, mixed-effects model, repeated measures (MMRM) analysis of the change from baseline for each postbaseline value and compared each ABBV-8E12 dose group with the placebo group. The model, which used all observed data, included fixed, categorical effects for treatment, site, visit, baseline score-by-visit interaction and treatment-by-visit interaction, with continuous fixed covariates for the corresponding baseline score.|LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.14|=|0.761|TWO_SIDED|95.0|-0.31|0.23|||Mixed-effects model, repeated measures||ABBV-8E12 2000 mg - Placebo|ABBV-8E12 2000 mg vs Placebo||0.23|-0.31|=0.761
72566573|NCT02985879|144663392|SUPERIORITY|The analysis utilized a likelihood-based, mixed-effects model, repeated measures (MMRM) analysis of the change from baseline for each postbaseline value and compared each ABBV-8E12 dose group with the placebo group. The model, which used all observed data, included fixed, categorical effects for treatment, site, visit, baseline score-by-visit interaction and treatment-by-visit interaction, with continuous fixed covariates for the corresponding baseline score.|LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.13|=|0.678|TWO_SIDED|95.0|-0.32|0.21|||Mixed-effects model, repeated measures||ABBV-8E12 4000 mg - Placebo|ABBV-8E12 4000 mg vs Placebo||0.21|-0.32|=0.678
72479339|NCT03486457|144484769|SUPERIORITY||LS mean difference|9.16|STANDARD_ERROR_OF_MEAN|12.273||0.4575|TWO_SIDED|95.0|-15.24|33.57|||Mixed Models Analysis|||Month 6, Induration: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||33.57|-15.24|0.4575
72479340|NCT03486457|144484769|SUPERIORITY||LS mean difference|0.69|STANDARD_ERROR_OF_MEAN|11.539||0.9523|TWO_SIDED|95.0|-22.26|23.65|||Mixed Models Analysis|||Month 6, Scaling: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||23.65|-22.26|0.9523
72479341|NCT03486457|144484770|SUPERIORITY||LS mean difference|-28.69|STANDARD_ERROR_OF_MEAN|8.386||0.0008|TWO_SIDED|95.0|-45.24|-12.15|||Mixed Models Analysis|||Month 1: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-12.15|-45.24|0.0008
72479342|NCT03486457|144484770|SUPERIORITY||LS mean difference|-46.47|STANDARD_ERROR_OF_MEAN|10.632|<|0.0001|TWO_SIDED|95.0|-67.45|-25.49|||Mixed Models Analysis|||Month 3: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-25.49|-67.45|<0.0001
72479343|NCT03486457|144484770|SUPERIORITY||LS mean difference|-26.76|STANDARD_ERROR_OF_MEAN|10.778||0.0141|TWO_SIDED|95.0|-48.05|-5.47|||Mixed Models Analysis|||Month 6: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-5.47|-48.05|0.0141
72479344|NCT03486457|144484771|SUPERIORITY||LS mean difference|-10.75|STANDARD_ERROR_OF_MEAN|2.399|<|0.0001|TWO_SIDED|95.0|-15.48|-6.02|||Mixed Models Analysis|||Month 1: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-6.02|-15.48|<0.0001
72479345|NCT03486457|144484771|SUPERIORITY||LS mean difference|-19.45|STANDARD_ERROR_OF_MEAN|2.575|<|0.0001|TWO_SIDED|95.0|-24.52|-14.37|||Mixed Models Analysis|||Month 3: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-14.37|-24.52|<0.0001
72479346|NCT03486457|144484771|SUPERIORITY||LS mean difference|-6.7|STANDARD_ERROR_OF_MEAN|2.289||0.0039|TWO_SIDED|95.0|-11.22|-2.18|||Mixed Models Analysis|||Month 6: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-2.18|-11.22|0.0039
72479347|NCT03486457|144484772|SUPERIORITY||Difference in percentage of participants|14.19|STANDARD_ERROR_OF_MEAN|5.89||0.016|TWO_SIDED|95.0|2.64|25.73|||Normal approximation|||Month 1: The normal approximation to the difference in binomial proportions was used to test the difference between the two treatment arms and to generate 95% CI and p-value for the difference in response rates.||25.73|2.64|0.0160
72479348|NCT03486457|144484772|SUPERIORITY||Difference in percentage of participants|25.65|STANDARD_ERROR_OF_MEAN|8.06||0.0015|TWO_SIDED|95.0|9.86|41.44|||Normal approximation|||Month 3: The normal approximation to the difference in binomial proportions was used to test the difference between the two treatment arms and to generate 95% CI and p-value for the difference in response rates.||41.44|9.86|0.0015
72566574|NCT02985879|144663393|SUPERIORITY|The analysis utilized a likelihood-based, mixed-effects model, repeated measures (MMRM) analysis of the change from baseline for each postbaseline value and compared each ABBV-8E12 dose group with the placebo group. The model, which used all observed data, included fixed, categorical effects for treatment, site, visit, baseline score-by-visit interaction and treatment-by-visit interaction, with continuous fixed covariates for the corresponding baseline score.|LS Mean Difference|1.0|STANDARD_ERROR_OF_MEAN|2.3|=|0.653|TWO_SIDED|95.0|-3.5|5.57|||Mixed-effects model, repeated measures||ABBV-8E12 2000 mg - Placebo|ABBV-8E12 2000 mg vs Placebo||5.57|-3.50|=0.653
72479349|NCT03486457|144484772|SUPERIORITY||Difference in percentage of participants|23.05|STANDARD_ERROR_OF_MEAN|9.16||0.0118|TWO_SIDED|95.0|5.11|41.0|||Normal approximation|||Month 6: The normal approximation to the difference in binomial proportions was used to test the difference between the two treatment arms and to generate 95% CI and p-value for the difference in response rates.||41.00|5.11|0.0118
72479350|NCT03486457|144484773|SUPERIORITY||LS mean difference|-3.09|STANDARD_ERROR_OF_MEAN|1.259||0.0156|TWO_SIDED|95.0|-5.58|-0.6|||Mixed Models Analysis|||Month 1: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-0.60|-5.58|0.0156
72479351|NCT03486457|144484773|SUPERIORITY||LS mean difference|-4.06|STANDARD_ERROR_OF_MEAN|0.989|<|0.0001|TWO_SIDED|95.0|-6.02|-2.1|||Mixed Models Analysis|||Month 3: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-2.10|-6.02|<0.0001
72479352|NCT03486457|144484773|SUPERIORITY||LS mean difference|-0.97|STANDARD_ERROR_OF_MEAN|0.346||0.0061|TWO_SIDED|95.0|-1.65|-0.28|||Mixed Models Analysis|||Month 6: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-0.28|-1.65|0.0061
72479353|NCT03486457|144484774|SUPERIORITY||Difference in percentage of participants|13.03|STANDARD_ERROR_OF_MEAN|10.01||0.193|TWO_SIDED|95.0|-6.59|32.64|||Normal approximation|||Month 1: The normal approximation to the difference in binomial proportions was used to test the difference between the two treatment arms and to generate 95% CI and p-value for the difference in response rates.||32.64|-6.59|0.1930
72479354|NCT03486457|144484774|SUPERIORITY||Difference in percentage of participants|24.3|STANDARD_ERROR_OF_MEAN|10.11||0.0162|TWO_SIDED|95.0|4.48|44.11|||Normal approximation|||Month 3: The normal approximation to the difference in binomial proportions was used to test the difference between the two treatment arms and to generate 95% CI and p-value for the difference in response rates.||44.11|4.48|0.0162
72479355|NCT03486457|144484774|SUPERIORITY||Difference in percentage of participants|4.07|STANDARD_ERROR_OF_MEAN|10.83||0.7068|TWO_SIDED|95.0|-17.15|25.3|||Normal approximation|||Month 6: The normal approximation to the difference in binomial proportions was used to test the difference between the two treatment arms and to generate 95% CI and p-value for the difference in response rates.||25.30|-17.15|0.7068
72479356|NCT03486457|144484775|SUPERIORITY||LS mean difference|-0.29|STANDARD_ERROR_OF_MEAN|0.271||0.2811|TWO_SIDED|95.0|-0.83|0.25|||Mixed Models Analysis|||Month 1: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||0.25|-0.83|0.2811
72566575|NCT02985879|144663393|SUPERIORITY|The primary efficacy analysis utilized a likelihood-based, mixed-effects model, repeated measures (MMRM) analysis of the change from baseline for each postbaseline value and compared each ABBV-8E12 dose group with the placebo group. The model, which used all observed data, included fixed, categorical effects for treatment, site, visit, baseline score-by-visit interaction and treatment-by-visit interaction, with continuous fixed covariates for the corresponding baseline score.|LS Mean Difference|1.0|STANDARD_ERROR_OF_MEAN|2.3|=|0.748|TWO_SIDED|95.0|-3.5|5.57|||Mixed-effects model, repeated measures||ABBV-8E12 4000 mg - Placebo|ABBV-8E12 4000 mg vs Placebo||5.57|-3.50|=0.748
72566576|NCT02985879|144663394|SUPERIORITY|The analysis utilized a likelihood-based, mixed-effects model, repeated measures (MMRM) analysis of the change from baseline for each postbaseline value and compared each ABBV-8E12 dose group with the placebo group. The model, which used all observed data, included fixed, categorical effects for treatment, site, visit, baseline score-by-visit interaction and treatment-by-visit interaction, with continuous fixed covariates for the corresponding baseline score.|LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.34|=|0.828|TWO_SIDED|95.0|-0.6|0.74|||Mixed-effects model, repeated measures||ABBV-8E12 2000 mg - Placebo|ABBV-8E12 2000 mg vs Placebo||0.74|-0.60|=0.828
72479357|NCT03486457|144484775|SUPERIORITY||LS mean difference|-0.37|STANDARD_ERROR_OF_MEAN|0.295||0.214|TWO_SIDED|95.0|-0.96|0.22|||Mixed Models Analysis|||Month 3: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||0.22|-0.96|0.2140
72479358|NCT03486457|144484775|SUPERIORITY||LS mean difference|-0.26|STANDARD_ERROR_OF_MEAN|0.239||0.2817|TWO_SIDED|95.0|-0.74|0.22|||Mixed Models Analysis|||Month 6: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||0.22|-0.74|0.2817
72479359|NCT03486457|144484776|SUPERIORITY||LS mean difference|-0.01|STANDARD_ERROR_OF_MEAN|0.182||0.9407|TWO_SIDED|95.0|-0.37|0.35|||Mixed Models Analysis|||Month 1: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||0.35|-0.37|0.9407
72479360|NCT03486457|144484776|SUPERIORITY||LS mean difference|-0.23|STANDARD_ERROR_OF_MEAN|0.293||0.4295|TWO_SIDED|95.0|-0.81|0.35|||Mixed Models Analysis|||Month 3: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||0.35|-0.81|0.4295
72479361|NCT03486457|144484776|SUPERIORITY||LS mean difference|-0.33|STANDARD_ERROR_OF_MEAN|0.314||0.2946|TWO_SIDED|95.0|-0.95|0.29|||Mixed Models Analysis|||Month 6: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||0.29|-0.95|0.2946
72479362|NCT03486457|144484777|SUPERIORITY||Difference in percentage of participants|21.32|STANDARD_ERROR_OF_MEAN|5.62||0.0001|TWO_SIDED|95.0|10.32|32.33|||Normal approximation|||Week 2: The normal approximation to the difference in binomial proportions was used to test the difference between the two treatment arms and to generate 95% CI and p-value for the difference in response rates.||32.33|10.32|0.0001
72479363|NCT03486457|144484777|SUPERIORITY||Difference in percentage of participants|36.03|STANDARD_ERROR_OF_MEAN|6.49|<|0.0001|TWO_SIDED|95.0|23.31|48.75|||Normal approximation|||Month 1: The normal approximation to the difference in binomial proportions was used to test the difference between the two treatment arms and to generate 95% CI and p-value for the difference in response rates.||48.75|23.31|<0.0001
72479364|NCT03486457|144484777|SUPERIORITY||Difference in percentage of participants|52.21|STANDARD_ERROR_OF_MEAN|5.79|<|0.0001|TWO_SIDED|95.0|40.86|63.55|||Normal approximation|||Month 2: The normal approximation to the difference in binomial proportions was used to test the difference between the two treatment arms and to generate 95% CI and p-value for the difference in response rates.||63.55|40.86|<0.0001
72479365|NCT03486457|144484777|SUPERIORITY||Difference in percentage of participants|39.71|STANDARD_ERROR_OF_MEAN|6.8|<|0.0001|TWO_SIDED|95.0|26.38|53.03|||Normal approximation|||Month 3: The normal approximation to the difference in binomial proportions was used to test the difference between the two treatment arms and to generate 95% CI and p-value for the difference in response rates.||53.03|26.38|<0.0001
72479366|NCT03486457|144484777|SUPERIORITY||Difference in percentage of participants|18.38|STANDARD_ERROR_OF_MEAN|7.23||0.011|TWO_SIDED|95.0|4.22|32.55|||Normal approximation|||Month 4: The normal approximation to the difference in binomial proportions was used to test the difference between the two treatment arms and to generate 95% CI and p-value for the difference in response rates.||32.55|4.22|0.0110
72479367|NCT03486457|144484777|SUPERIORITY||Difference in percentage of participants|16.18|STANDARD_ERROR_OF_MEAN|6.8||0.0173|TWO_SIDED|95.0|2.85|29.5|||Normal approximation|||Month 6: The normal approximation to the difference in binomial proportions was used to test the difference between the two treatment arms and to generate 95% CI and p-value for the difference in response rates.||29.50|2.85|0.0173
72479368|NCT03486457|144484778|SUPERIORITY||LS mean difference|-0.63|STANDARD_ERROR_OF_MEAN|0.08|<|0.0001|TWO_SIDED|95.0|-0.79|-0.47|||Mixed Models Analysis|||Week 2: Analysis performed using mixed model for repeated measures (MMRM) which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-0.47|-0.79|<0.0001
72479369|NCT03486457|144484778|SUPERIORITY||LS mean difference|-0.81|STANDARD_ERROR_OF_MEAN|0.095|<|0.0001|TWO_SIDED|95.0|-0.99|-0.62|||Mixed Models Analysis|||Month 1: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-0.62|-0.99|<0.0001
72479370|NCT03486457|144484778|SUPERIORITY||LS mean difference|-0.87|STANDARD_ERROR_OF_MEAN|0.105|<|0.0001|TWO_SIDED|95.0|-1.08|-0.66|||Mixed Models Analysis|||Month 2: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-0.66|-1.08|<0.0001
72479371|NCT03486457|144484778|SUPERIORITY||LS mean difference|-1.04|STANDARD_ERROR_OF_MEAN|0.122|<|0.0001|TWO_SIDED|95.0|-1.28|-0.8|||Mixed Models Analysis|||Month 3: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-0.80|-1.28|<0.0001
72479372|NCT03486457|144484778|SUPERIORITY||LS mean difference|-0.44|STANDARD_ERROR_OF_MEAN|0.129||0.0009|TWO_SIDED|95.0|-0.69|-0.18|||Mixed Models Analysis|||Month 4: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-0.18|-0.69|0.0009
72479373|NCT03486457|144484778|SUPERIORITY||LS mean difference|-0.23|STANDARD_ERROR_OF_MEAN|0.145||0.1202|TWO_SIDED|95.0|-0.51|0.06|||Mixed Models Analysis|||Month 6: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||0.06|-0.51|0.1202
72479374|NCT03486457|144484779|SUPERIORITY||LS mean difference|3.72|STANDARD_ERROR_OF_MEAN|0.998||0.0003|TWO_SIDED|95.0|1.76|5.69|||Mixed Models Analysis|||Month 1, Physical Functioning Domain: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||5.69|1.76|0.0003
72479375|NCT03486457|144484779|SUPERIORITY||LS mean difference|3.18|STANDARD_ERROR_OF_MEAN|1.102||0.0043|TWO_SIDED|95.0|1.01|5.35|||Mixed Models Analysis|||Month 1, Role - Physical Domain: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||5.35|1.01|0.0043
72479376|NCT03486457|144484779|SUPERIORITY||LS mean difference|3.12|STANDARD_ERROR_OF_MEAN|0.861||0.0004|TWO_SIDED|95.0|1.42|4.82|||Mixed Models Analysis|||Month 1, Bodily Pain Domain: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||4.82|1.42|0.0004
72479377|NCT03486457|144484779|SUPERIORITY||LS mean difference|3.54|STANDARD_ERROR_OF_MEAN|0.938||0.0002|TWO_SIDED|95.0|1.69|5.39|||Mixed Models Analysis|||Month 1, General Health Domain: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||5.39|1.69|0.0002
72479378|NCT03486457|144484779|SUPERIORITY||LS mean difference|3.04|STANDARD_ERROR_OF_MEAN|1.203||0.0123|TWO_SIDED|95.0|0.67|5.41|||Mixed Models Analysis|||Month 1, Vitality Domain: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||5.41|0.67|0.0123
72509337|NCT01301742|144549122|NON_INFERIORITY_OR_EQUIVALENCE|Ratio calculated as empa and gemfibrozil divided by empa alone|Geometric Mean Ratio|158.5|STANDARD_DEVIATION|7.5|||TWO_SIDED|90.0|151.77|165.53|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment.|Standard deviation is actually the intra-individual geometric coefficient of variation (gCV)|||165.53|151.77|
72509338|NCT01301742|144549123|NON_INFERIORITY_OR_EQUIVALENCE|Ratio calculated as empa and gemfibrozil divided by empa alone|Geometric Mean Ratio|115.0|STANDARD_DEVIATION|13.8|||TWO_SIDED|90.0|106.15|124.59|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment.|Standard deviation is actually the intra-individual gCV|||124.59|106.15|
72479379|NCT03486457|144484779|SUPERIORITY||LS mean difference|2.58|STANDARD_ERROR_OF_MEAN|1.115||0.0216|TWO_SIDED|95.0|0.38|4.78|||Mixed Models Analysis|||Month 1, Social Function Domain: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||4.78|0.38|0.0216
72479380|NCT03486457|144484779|SUPERIORITY||LS mean difference|2.04|STANDARD_ERROR_OF_MEAN|1.336||0.129|TWO_SIDED|95.0|-0.6|4.67|||Mixed Models Analysis|||Month 1, Role - Emotional Domain: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||4.67|-0.60|0.1290
72479381|NCT03486457|144484779|SUPERIORITY||LS mean difference|1.91|STANDARD_ERROR_OF_MEAN|1.172||0.1043|TWO_SIDED|95.0|-0.4|4.22|||Mixed Models Analysis|||Month 1, Mental Health Domain: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||4.22|-0.40|0.1043
72479382|NCT03486457|144484779|SUPERIORITY||LS mean difference|3.77|STANDARD_ERROR_OF_MEAN|0.763|<|0.0001|TWO_SIDED|95.0|2.26|5.27|||Mixed Models Analysis|||Month 1, Physical Component Summary: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||5.27|2.26|<0.0001
72479383|NCT03486457|144484779|SUPERIORITY||LS mean difference|1.78|STANDARD_ERROR_OF_MEAN|1.178||0.1318|TWO_SIDED|95.0|-0.54|4.1|||Mixed Models Analysis|||Month 1, Mental Component Summary: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||4.10|-0.54|0.1318
72479384|NCT03486457|144484779|SUPERIORITY||LS mean difference|2.53|STANDARD_ERROR_OF_MEAN|1.225||0.0402|TWO_SIDED|95.0|0.11|4.95|||Mixed Models Analysis|||Month 3, Physical Functioning Domain: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||4.95|0.11|0.0402
72509339|NCT01301742|144549124|NON_INFERIORITY_OR_EQUIVALENCE|Ratio calculated as empa and gemfibrozil divided by empa alone|Geometric Mean Ratio|158.29|STANDARD_DEVIATION|7.7|||TWO_SIDED|90.0|151.41|165.49|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment.|Standard deviation is actually the intra-individual gCV|||165.49|151.41|
72509340|NCT03141086|144549125|SUPERIORITY||Mean Difference (Final Values)|1.711||||0.1272|TWO_SIDED|95.0|-1.34|4.762|||ANOVA|||||4.762|-1.340|0.1272
72509341|NCT03141086|144549126|SUPERIORITY||Mean Difference (Final Values)|2.866||||0.0607|TWO_SIDED|95.0|-0.821|6.553|||Mixed Models Analysis|||3.5 hours post dose||6.553|-0.821|0.0607
72509342|NCT03141086|144549126|SUPERIORITY||Mean Difference (Net)|1.975||||0.0919|TWO_SIDED|95.0|-1.024|4.973|||Mixed Models Analysis|||5.5 hours post dose||4.973|-1.024|0.0919
72509343|NCT03141086|144549126|SUPERIORITY||Mean Difference (Net)|1.576||||0.0811|TWO_SIDED|95.0|-0.697|3.848|||Mixed Models Analysis|||7.5 hours post dose||3.848|-0.697|0.0811
72479385|NCT03486457|144484779|SUPERIORITY||LS mean difference|4.41|STANDARD_ERROR_OF_MEAN|1.227||0.0004|TWO_SIDED|95.0|1.99|6.83|||Mixed Models Analysis|||Month 3, Role - Physical Domain: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||6.83|1.99|0.0004
72479386|NCT03486457|144484779|SUPERIORITY||LS mean difference|5.29|STANDARD_ERROR_OF_MEAN|1.069|<|0.0001|TWO_SIDED|95.0|3.18|7.4|||Mixed Models Analysis|||Month 3, Bodily Pain Domain: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||7.40|3.18|<0.0001
72479387|NCT03486457|144484779|SUPERIORITY||LS mean difference|5.28|STANDARD_ERROR_OF_MEAN|1.261|<|0.0001|TWO_SIDED|95.0|2.79|7.76|||Mixed Models Analysis|||Month 3, General Health Domain: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||7.76|2.79|<0.0001
72509344|NCT03141086|144549126|SUPERIORITY||Mean Difference (Net)|0.879||||0.2026|TWO_SIDED|95.0|-1.268|3.026|||Mixed Models Analysis|||9.5 hours post dose||3.026|-1.268|0.2026
72479388|NCT03486457|144484779|SUPERIORITY||LS mean difference|2.1|STANDARD_ERROR_OF_MEAN|1.366||0.1254|TWO_SIDED|95.0|-0.59|4.8|||Mixed Models Analysis|||Month 3, Vitality Domain: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||4.80|-0.59|0.1254
72479389|NCT03486457|144484779|SUPERIORITY||LS mean difference|4.34|STANDARD_ERROR_OF_MEAN|1.186||0.0003|TWO_SIDED|95.0|2.0|6.68|||Mixed Models Analysis|||Month 3, Social Function Domain: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||6.68|2.00|0.0003
72509345|NCT01678807|144549156|SUPERIORITY_OR_OTHER||Percent Difference|13.8|||||TWO_SIDED|95.0|-3.4|30.3|||||Estimate based on Miettinen \& Nurminen method stratified by asthma status.|||30.3|-3.4|
72509346|NCT01678807|144549156|SUPERIORITY_OR_OTHER||Percent Difference|10.8|||||TWO_SIDED|95.0|-6.4|27.4|||||Estimate based on Miettinen \& Nurminen method stratified by asthma status.|||27.4|-6.4|
72509347|NCT01678807|144549157|SUPERIORITY_OR_OTHER||Percent Difference|6.2|||||TWO_SIDED|95.0|0.4|14.8|||||Estimate based on Miettinen \& Nurminen method stratified by asthma status.|||14.8|0.4|
72509348|NCT01678807|144549157|SUPERIORITY_OR_OTHER||Percent Difference|6.2|||||TWO_SIDED|95.0|0.4|14.8|||||Estimate based on Miettinen \& Nurminen method stratified by asthma status.|||14.8|0.4|
72509349|NCT06018350|144549187|OTHER|||||||0.002|||||||McNemar|||||||0.002
72509350|NCT03625986|144549189|OTHER||Mean Difference (Final Values)|-186.68||||0.0039|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.0039
72509351|NCT03625986|144549190|OTHER||Mean Difference (Final Values)|-0.06||||0.8103|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.8103
72509352|NCT03625986|144549191|OTHER||Mean Difference (Final Values)|-3.14||||0.0105|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.0105
72509353|NCT03625986|144549192|OTHER||Mean Difference (Final Values)|2415.93||||0.0182|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.0182
72509354|NCT03625986|144549193|OTHER||Mean Difference (Final Values)|1.18||||0.8429|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.8429
72509355|NCT03625986|144549194|OTHER||Mean Difference (Final Values)|0.49||||0.4881|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.4881
72509356|NCT03625986|144549195|OTHER||Mean Difference (Final Values)|1.76||||0.0835|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.0835
72509357|NCT03625986|144549196|OTHER||Mean Difference (Final Values)|-0.96||||0.043|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.043
72509358|NCT03625986|144549197|OTHER||Odds Ratio (OR)|4.35||||0.0052|TWO_SIDED||||||Fisher Exact|||||||0.0052
72509359|NCT03625986|144549198|OTHER||Mean Difference (Final Values)|-1.95||||0.0797|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.0797
72509360|NCT03625986|144549199|OTHER||Mean Difference (Final Values)|-1.44||||0.1084|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.1084
72509361|NCT03625986|144549200|OTHER||Mean Difference (Final Values)|3.81||||0.3469|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.3469
72509362|NCT03625986|144549201|OTHER||Odds Ratio (OR)|3.3632||||0.0272|TWO_SIDED||||||Fisher Exact|||||||0.0272
72509363|NCT03625986|144549202|OTHER||Mean Difference (Final Values)|0.6||||0.589|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.589
72509364|NCT03625986|144549203|OTHER||Mean Difference (Final Values)|-0.3||||0.5448|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.5448
72509365|NCT03625986|144549204|OTHER||Mean Difference (Final Values)|15.3||||0.65|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.65
72509366|NCT03625986|144549205|OTHER||Mean Difference (Final Values)|-4.0||||0.1567|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.1567
72509367|NCT01109004|144549231|SUPERIORITY|||||||0.87||||||The primary analysis involved pairwise comparisons of PFS between the three treatment arms. To control the familywise type I error rate at 0.05, two-sided testing was performed at a Bonferroni-adjusted significance level of 0.0167 = 0.05 / 3.|Log Rank|The log rank test was stratified on risk status (high risk vs. standard risk)||The null hypothesis is that the percentages of participants with PFS at 38 months post-randomization are equal for those receiving Tandem auto transplant and RVD consolidation therapy.||||0.87
72509368|NCT01109004|144549231|SUPERIORITY|||||||0.37||||||The primary analysis involved pairwise comparisons of PFS between the three treatment arms. To control the familywise type I error rate at 0.05, two-sided testing was performed at a Bonferroni-adjusted significance level of 0.0167 = 0.05 / 3.|Log Rank|The log rank test was stratified on risk status (high risk vs. standard risk)||The null hypothesis is that the percentages of participants with PFS at 38 months post-randomization are equal for those receiving Tandem auto transplant and Lenalidomide maintenance therapy.||||0.37
72509369|NCT01109004|144549231|SUPERIORITY|||||||0.27||||||The primary analysis involved pairwise comparisons of PFS between the three treatment arms. To control the familywise type I error rate at 0.05, two-sided testing was performed at a Bonferroni-adjusted significance level of 0.0167 = 0.05 / 3.|Log Rank|The log rank test was stratified on risk status (high risk vs. standard risk)||The null hypothesis is that the percentages of participants with PFS at 38 months post-randomization are equal for those receiving RVD consolidation and Lenalidomide maintenance therapy.||||0.27
72400232|NCT02016625|144308269|NON_INFERIORITY_OR_EQUIVALENCE|H0: ratio is outside of interval (80%, 125%) VS H1: ratio is inside of interval (80%, 125%)|gMean ratio (%)|116.92|STANDARD_ERROR_OF_MEAN|11.0||0.065|TWO_SIDED|90.0|108.674|125.801|||ANOVA||gMean ratio of cyclo+FDV to FDV treatment. The standard error of the mean actually is the geometric coefficient of variation (%).|gMean ratio of cyclo+FDV to FDV treatment. The statistical model used for the analysis of primary endpoints was an analysis of variance (ANOVA) model on the logarithmic scale. This model accounted for variation from 'subject' and 'treatment' effects. The 'subject' effect was considered to be random, whereas the 'treatment' effect was considered as fixed.||125.801|108.674|0.0650
72623630|NCT00600340|144778099|NON_INFERIORITY|"Null hypothesis: Hazard ratio (HR) \>= 1.33~Based on Cox proportional hazards model adjusted by stratification factors at randomization:~1. estrogen and/or progesterone status (positive vs. other)~2. country~3. menopausal status (premenopausal or male \<=50 years of age vs. postmenopausal or male \>50 years of age)"|Hazard Ratio (HR)|1.027||||0.1534|ONE_SIDED|97.5||1.606||Based on approach using repeated confidence intervals, with one-sided 97.5% repeated confidence intervals|Regression, Cox||HR is the hazard rate of Bevacizumab Plus Capecitabine divided by hazard rate of Bevacizumab plus Paclitaxel.|HR of Bevacizumab Plus Capecitabine vs. Bevacizumab plus Paclitaxel for OS (interim, stratified).||1.606||0.1534
72623631|NCT00600340|144778099|NON_INFERIORITY|"Null hypothesis: Hazard ratio (HR) \>= 1.33~Based on Cox proportional hazards model adjusted by stratification factors at randomization:~1. estrogen and/or progesterone status (positive vs. other)~2. country~3. menopausal status (premenopausal or male \<=50 years of age vs. postmenopausal or male \>50 years of age)"|Hazard Ratio (HR)|1.035||||0.0085|ONE_SIDED|97.5||1.273||Based on approach using repeated confidence intervals, with one-sided 97.5% repeated confidence intervals|Regression, Cox||HR is the hazard rate of Bevacizumab Plus Capecitabine divided by hazard rate of Bevacizumab plus Paclitaxel.|HR of Bevacizumab Plus Capecitabine vs. Bevacizumab plus Paclitaxel for OS (final, stratified).||1.273||0.0085
72623632|NCT00600340|144778099|NON_INFERIORITY|Null hypothesis: Hazard Ratio (HR) \>= 1.33 Based on Cox proportional hazards model.|Hazard Ratio (HR)|1.058||||0.1778|ONE_SIDED|97.5||1.623||Based on approach using repeated confidence intervals, with one-sided 97.5% repeated confidence intervals|Regression, Cox||HR is the hazard rate of Bevacizumab Plus Capecitabine divided by hazard rate of Bevacizumab plus Paclitaxel.|HR of Bevacizumab Plus Capecitabine vs. Bevacizumab plus Paclitaxel for OS (interim, unstratified).||1.623||0.1778
72623633|NCT00600340|144778099|NON_INFERIORITY|Null hypothesis: Hazard Ratio (HR) \>= 1.33 Based on Cox proportional hazards model.|Hazard Ratio (HR)|1.126||||0.049|ONE_SIDED|97.5||1.37||Based on approach using repeated confidence intervals, with one-sided 97.5% repeated confidence intervals|Regression, Cox||HR is the hazard rate of Bevacizumab Plus Capecitabine divided by hazard rate of Bevacizumab plus Paclitaxel.|HR of Bevacizumab Plus Capecitabine vs. Bevacizumab plus Paclitaxel for OS (final, unstratified).||1.37||0.049
72623634|NCT00600340|144778105|SUPERIORITY|OR is the odds for objective response of Bevacizumab Plus Capecitabine divided by the odds for objective response of Bevacizumab plus Paclitaxel|Odds Ratio (OR)|0.47|||<|0.0001|TWO_SIDED|95.0|0.33|0.67||"Test adjusted by stratification factors at randomization:~1. estrogen and/or progesterone status (positive vs. other)~2. country~3. menopausal status (premenopausal or male \<=50 years of age vs. postmenopausal or male \>50 years of age"|Cochran-Mantel-Haenszel||OR is the odds for objective response of Bevacizumab Plus Capecitabine divided by the odds for objective response of Bevacizumab plus Paclitaxel|Odds Ratio (OR) of objective response and Cochran-Mantel-Haenszel (CMH) test (stratified)||0.67|0.33|< 0.0001
72623635|NCT00600340|144778105|SUPERIORITY||Risk Difference (RD)|-17.0|||||TWO_SIDED|95.0|-24.0|-9.0|||||Difference calculated as ORR in Bevacizumab Plus Capecitabine minus ORR in Bevacizumab plus Paclitaxel, units in percent.|Difference in ORR in Bevacizumab Plus Capecitabine vs. Bevacizumab plus Paclitaxel||-9|-24|
72623636|NCT00600340|144778105|SUPERIORITY|OR is the odds for disease control of Bevacizumab Plus Capecitabine divided by the odds for disease control of Bevacizumab plus Paclitaxel|Odds Ratio (OR)|0.43||||0.0006|TWO_SIDED|95.0|0.27|0.7||"Test adjusted by stratification factors at randomization:~1. estrogen and/or progesterone status (positive vs. other)~2. country~3. menopausal status (premenopausal or male \<=50 years of age vs. postmenopausal or male \>50 years of age"|Cochran-Mantel-Haenszel||OR is the odds for disease control of Bevacizumab Plus Capecitabine divided by the odds for disease control of Bevacizumab plus Paclitaxel|OR of disease control and CMH test (stratified)||0.70|0.27|0.0006
72479390|NCT03486457|144484779|SUPERIORITY||LS mean difference|3.43|STANDARD_ERROR_OF_MEAN|1.384||0.014|TWO_SIDED|95.0|0.7|6.16|||Mixed Models Analysis|||Month 3, Role - Emotional Domain: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||6.16|0.70|0.0140
72509370|NCT01109004|144549232|SUPERIORITY|||||||0.92||||||Two sided testing was performed at a significance level of 0.05|Gray's test|Death prior to disease progression was treated as a competing risk||The null hypothesis is that the percentages of participants with disease progression at 38 months post-randomization are equal for those receiving Tandem auto transplant and RVD consolidation therapy.||||0.92
72623637|NCT00600340|144778105|SUPERIORITY||Risk Difference (RD)|-12.0|||||TWO_SIDED|95.0|-18.0|-6.0|||||Difference calculated as the DCR in Bevacizumab Plus Capecitabine minus ORR in Bevacizumab plus Paclitaxel, units in percent.|Difference in DCR in Bevacizumab Plus Capecitabine vs. Bevacizumab plus Paclitaxel||-6|-18|
72509371|NCT01109004|144549232|SUPERIORITY|||||||0.21||||||Two sided testing was performed at a significance level of 0.05|Gray's test|Death prior to disease progression was treated as a competing risk||The null hypothesis is that the percentages of participants with disease progression at 38 months post-randomization are equal for those receiving Tandem auto transplant and Lenalidomide maintenance therapy.||||0.21
72509372|NCT01109004|144549232|SUPERIORITY|||||||0.22||||||Two sided testing was performed at a significance level of 0.05|Gray's test|Death prior to disease progression was treated as a competing risk||The null hypothesis is that the percentages of participants with disease progression at 38 months post-randomization are equal for those receiving RVD consolidation and Lenalidomide maintenance therapy.||||0.22
72479391|NCT03486457|144484779|SUPERIORITY||LS mean difference|3.47|STANDARD_ERROR_OF_MEAN|1.268||0.0067|TWO_SIDED|95.0|0.97|5.98|||Mixed Models Analysis|||Month 3, Mental Health Domain: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||5.98|0.97|0.0067
72479392|NCT03486457|144484779|SUPERIORITY||LS mean difference|4.17|STANDARD_ERROR_OF_MEAN|0.986|<|0.0001|TWO_SIDED|95.0|2.23|6.12|||Mixed Models Analysis|||Month 3, Physical Component Summary: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||6.12|2.23|<0.0001
72479393|NCT03486457|144484779|SUPERIORITY||LS mean difference|3.27|STANDARD_ERROR_OF_MEAN|1.248||0.0094|TWO_SIDED|95.0|0.81|5.73|||Mixed Models Analysis|||Month 3, Mental Component Summary: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||5.73|0.81|0.0094
72479394|NCT03486457|144484779|SUPERIORITY||LS mean difference|0.39|STANDARD_ERROR_OF_MEAN|1.049||0.7098|TWO_SIDED|95.0|-1.68|2.46|||Mixed Models Analysis|||Month 6, Physical Functioning Domain: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||2.46|-1.68|0.7098
72400233|NCT02016625|144308270|NON_INFERIORITY_OR_EQUIVALENCE|H0: ratio is outside of interval (80%, 125%) VS H1: ratio is inside of interval (80%, 125%)|gMean ratio (%)|122.68|STANDARD_ERROR_OF_MEAN|23.9||0.4181|TWO_SIDED|90.0|104.8|143.6|||ANOVA||gMean ratio of cyclo+FDV to FDV treatment. The standard error of the mean actually is the geometric coefficient of variation (%).|gMean ratio of cyclo+FDV to FDV treatment. The statistical model used for the analysis of primary endpoints was an analysis of variance (ANOVA) model on the logarithmic scale. This model accounted for variation from 'subject' and 'treatment' effects. The 'subject' effect was considered to be random, whereas the 'treatment' effect was considered as fixed.||143.60|104.80|0.4181
72400234|NCT02016625|144308271|NON_INFERIORITY_OR_EQUIVALENCE|H0: ratio is outside of interval (80%, 125%) VS H1: ratio is inside of interval (80%, 125%)|gMean ratio (%)|127.41|STANDARD_ERROR_OF_MEAN|16.8||0.6207|TWO_SIDED|90.0|114.453|141.827|||ANOVA||gMean ratio of tac+FDV to FDV treatment. The standard error of the mean actually is the geometric coefficient of variation (%).|gMean ratio of tac+FDV to FDV treatment. The statistical model used for the analysis of primary endpoints was an analysis of variance (ANOVA) model on the logarithmic scale. This model accounted for variation from 'subject' and 'treatment' effects. The 'subject' effect was considered to be random, whereas the 'treatment' effect was considered as fixed.||141.827|114.453|0.6207
72479395|NCT03486457|144484779|SUPERIORITY||LS mean difference|1.04|STANDARD_ERROR_OF_MEAN|1.234||0.4019|TWO_SIDED|95.0|-1.4|3.47|||Mixed Models Analysis|||Month 6, Role - Physical Domain: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||3.47|-1.40|0.4019
72479396|NCT03486457|144484779|SUPERIORITY||LS mean difference|0.37|STANDARD_ERROR_OF_MEAN|1.186||0.7537|TWO_SIDED|95.0|-1.97|2.71|||Mixed Models Analysis|||Month 6, Bodily Pain Domain: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||2.71|-1.97|0.7537
72509373|NCT01109004|144549233|SUPERIORITY|||||||0.26||||||Two sided testing was performed at a significance level of 0.05|Log Rank|||The null hypothesis is that the percentages of participants with OS at 38 months post-randomization are equal for those receiving Tandem auto transplant and RVD consolidation therapy.||||0.26
72509374|NCT01109004|144549233|SUPERIORITY|||||||0.53||||||Two sided testing was performed at a significance level of 0.05|Log Rank|||The null hypothesis is that the percentages of participants with OS at 38 months post-randomization are equal for those receiving Tandem auto transplant and Lenalidomide maintenance therapy.||||0.53
72509375|NCT01109004|144549233|SUPERIORITY|||||||0.57||||||Two sided testing was performed at a significance level of 0.05|Log Rank|||The null hypothesis is that the percentages of participants with OS at 38 months post-randomization are equal for those receiving RVD consolidation and Lenalidomide maintenance therapy.||||0.57
72509376|NCT01109004|144549234|SUPERIORITY|||||||0.63||||||Two sided testing was performed at a significance level of 0.05|Gray's test|Death prior to disease progression was treated as a competing risk||The null hypothesis is that the percentages of participants with TRM at 38 months post-randomization are equal for those receiving Tandem auto transplant and RVD consolidation therapy.||||0.63
72479397|NCT03486457|144484779|SUPERIORITY||LS mean difference|1.22|STANDARD_ERROR_OF_MEAN|1.33||0.3595|TWO_SIDED|95.0|-1.4|3.85|||Mixed Models Analysis|||Month 6, General Health Domain: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||3.85|-1.40|0.3595
72479398|NCT03486457|144484779|SUPERIORITY||LS mean difference|1.99|STANDARD_ERROR_OF_MEAN|1.52||0.1919|TWO_SIDED|95.0|-1.01|4.99|||Mixed Models Analysis|||Month 6, Vitality Domain: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||4.99|-1.01|0.1919
72479399|NCT03486457|144484779|SUPERIORITY||LS mean difference|0.28|STANDARD_ERROR_OF_MEAN|1.209||0.8163|TWO_SIDED|95.0|-2.1|2.67|||Mixed Models Analysis|||Month 6, Social Function Domain: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||2.67|-2.10|0.8163
72479400|NCT03486457|144484779|SUPERIORITY||LS mean difference|2.23|STANDARD_ERROR_OF_MEAN|1.368||0.1048|TWO_SIDED|95.0|-0.47|4.93|||Mixed Models Analysis|||Month 6, Role - Emotional Domain: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||4.93|-0.47|0.1048
72509377|NCT01109004|144549234|SUPERIORITY|||||||0.15||||||Two sided testing was performed at a significance level of 0.05|Gray's test|Death prior to disease progression was treated as a competing risk||The null hypothesis is that the percentages of participants with TRM at 38 months post-randomization are equal for those receiving Tandem auto transplant and Lenalidomide maintenance therapy.||||0.15
72623638|NCT00600340|144778106|SUPERIORITY|OR is the odds for objective response of Bevacizumab Plus Capecitabine divided by the odds for objective response of Bevacizumab plus Paclitaxel|Odds Ratio (OR)|0.45|||<|0.0001|TWO_SIDED|95.0|0.31|0.65||"Test adjusted by stratification factors at randomization:~1. estrogen and/or progesterone status (positive vs. other)~2. country~3. menopausal status (premenopausal or male \<=50 years of age vs. postmenopausal or male \>50 years of age"|Cochran-Mantel-Haenszel||OR is the odds for objective response of Bevacizumab Plus Capecitabine divided by the odds for objective response of Bevacizumab plus Paclitaxel|OR of objective response and CMH test (stratified)||0.65|0.31|< 0.0001
72479401|NCT03486457|144484779|SUPERIORITY||LS mean difference|0.71|STANDARD_ERROR_OF_MEAN|1.392||0.6118|TWO_SIDED|95.0|-2.04|3.45|||Mixed Models Analysis|||Month 6, Mental Health Domain: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||3.45|-2.04|0.6118
72479402|NCT03486457|144484779|SUPERIORITY||LS mean difference|0.39|STANDARD_ERROR_OF_MEAN|1.014||0.6996|TWO_SIDED|95.0|-1.61|2.39|||Mixed Models Analysis|||Month 6, Physical Component Summary: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||2.39|-1.61|0.6996
72509378|NCT01109004|144549234|SUPERIORITY|||||||0.33||||||Two sided testing was performed at a significance level of 0.05|Gray's test|Death prior to disease progression was treated as a competing risk||The null hypothesis is that the percentages of participants with TRM at 38 months post-randomization are equal for those receiving RVD consolidation and Lenalidomide maintenance therapy.||||0.33
72509379|NCT02410902|144549262|OTHER|ANCOVA using MMRM analysis|Mean Difference (Final Values)|-2.56||||0.038|TWO_SIDED|95.0|-4.98|-0.14|||ANCOVA|||||-0.14|-4.98|0.038
72623639|NCT00600340|144778106|SUPERIORITY||Risk Difference (RD)|-18.0|||||TWO_SIDED|95.0|-26.0|-10.0|||||Difference calculated as ORR in Bevacizumab Plus Capecitabine minus ORR in Bevacizumab plus Paclitaxel, units in percent.|Difference in ORR in Bevacizumab Plus Capecitabine vs. Bevacizumab plus Paclitaxel||-10|-26|
72623640|NCT00600340|144778106|SUPERIORITY|OR is the odds for disease control of Bevacizumab Plus Capecitabine divided by the odds for disease control of Bevacizumab plus Paclitaxel|Odds Ratio (OR)|0.39||||0.0003|TWO_SIDED|95.0|0.24|0.65||"Test adjusted by stratification factors at randomization:~1. estrogen and/or progesterone status (positive vs. other)~2. country~3. menopausal status (premenopausal or male \<=50 years of age vs. postmenopausal or male \>50 years of age"|Cochran-Mantel-Haenszel||OR is the odds for disease control of Bevacizumab Plus Capecitabine divided by the odds for disease control of Bevacizumab plus Paclitaxel|OR of disease control and CMH test (stratified)||0.65|0.24|0.0003
72623641|NCT00600340|144778106|SUPERIORITY||Risk Difference (RD)|-12.0|||||TWO_SIDED|95.0|-19.0|-6.0|||||Difference calculated as the DCR in Bevacizumab Plus Capecitabine minus ORR in Bevacizumab plus Paclitaxel, units in percent.|Difference in DCR in Bevacizumab Plus Capecitabine vs. Bevacizumab plus Paclitaxel||-6|-19|
72623642|NCT00600340|144778107|SUPERIORITY|OR is the odds for objective response of Bevacizumab Plus Capecitabine divided by the odds for objective response of Bevacizumab plus Paclitaxel|Odds Ratio (OR)|0.44|||<|0.0001|TWO_SIDED|95.0|0.31|0.63||"Test adjusted by stratification factors at randomization:~1. estrogen and/or progesterone status (positive vs. other)~2. country~3. menopausal status (premenopausal or male \<=50 years of age vs. postmenopausal or male \>50 years of age"|Cochran-Mantel-Haenszel||OR is the odds for objective response of Bevacizumab Plus Capecitabine divided by the odds for objective response of Bevacizumab plus Paclitaxel|OR of objective response and CMH test (stratified)||0.63|0.31|< 0.0001
72400235|NCT02016625|144308272|NON_INFERIORITY_OR_EQUIVALENCE|H0: ratio is outside of interval (80%, 125%) VS H1: ratio is inside of interval (80%, 125%)|gMean ratio (%)|136.85|STANDARD_ERROR_OF_MEAN|22.4||0.8592|TWO_SIDED|90.0|118.683|157.793|||ANOVA||gMean ratio of tac+FDV to FDV treatment. The standard error of the mean actually is the geometric coefficient of variation (%).|gMean ratio of tac+FDV to FDV treatment. The statistical model used for the analysis of primary endpoints was an analysis of variance (ANOVA) model on the logarithmic scale. This model accounted for variation from 'subject' and 'treatment' effects. The 'subject' effect was considered to be random, whereas the 'treatment' effect was considered as fixed.||157.793|118.683|0.8592
72479403|NCT03486457|144484779|SUPERIORITY||LS mean difference|1.78|STANDARD_ERROR_OF_MEAN|1.424||0.2122|TWO_SIDED|95.0|-1.03|4.59|||Mixed Models Analysis|||Month 6, Mental Component Summary: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||4.59|-1.03|0.2122
72509380|NCT02410902|144549263|OTHER|ANCOVA using MMRM analysis|Mean Difference (Final Values)|-1.07||||0.325|TWO_SIDED|95.0|-3.21|1.07|||ANCOVA|||||1.07|-3.21|0.325
72623643|NCT00600340|144778107|SUPERIORITY||Risk Difference (RD)|-20.0|||||TWO_SIDED|95.0|-28.0|-11.0|||||Difference calculated as ORR in Bevacizumab Plus Capecitabine minus ORR in Bevacizumab plus Paclitaxel, units in percent.|Difference in ORR in Bevacizumab Plus Capecitabine vs. Bevacizumab plus Paclitaxel||-11|-28|
72479404|NCT03486457|144484780|SUPERIORITY||LS mean difference|-0.12|STANDARD_ERROR_OF_MEAN|0.067||0.0722|TWO_SIDED|95.0|-0.25|0.01|||Mixed Models Analysis|||Month 1, Mobility: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||0.01|-0.25|0.0722
72479405|NCT03486457|144484780|SUPERIORITY||LS mean difference|-0.16|STANDARD_ERROR_OF_MEAN|0.055||0.0035|TWO_SIDED|95.0|-0.27|-0.05|||Mixed Models Analysis|||Month 1, Self-Care: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-0.05|-0.27|0.0035
72479406|NCT03486457|144484780|SUPERIORITY||LS mean difference|-0.14|STANDARD_ERROR_OF_MEAN|0.069||0.0475|TWO_SIDED|95.0|-0.27|0.0|||Mixed Models Analysis|||Month 1, Usual Activities: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||0.00|-0.27|0.0475
72509381|NCT03059810|144549272|NON_INFERIORITY|A non-inferiority margin of -5 points was used. This margin is based on a 10% shift in the distribution of CLUE scores.|Mean Difference (Final Values)|0.7|STANDARD_DEVIATION|2.63|||TWO_SIDED|95.0|-4.6|5.9|||Linear mixed model (LMM)|A 95% Confidence Interval for the least squares mean difference between the follow up and baseline was used to test for non-inferiority.|Mean difference was calculated as Test (at 12-16 days follow up) - Habitual (at baseline)|It was a single arm study and the subjects' overall vision was compared against the baseline with the habitual lens. Sample size was determined using Power procedure in SAS 9.4 using the input from historical data (alpha=0.05).||5.9|-4.6|
72509382|NCT03395197|144549332|SUPERIORITY||Hazard Ratio (HR)|0.627|||<|0.0001|TWO_SIDED|95.0|0.506|0.777||1-sided|Log Rank||Hazard ratio was based on Cox proportional hazards model; under proportional hazards, if hazard ratio \< 1, it indicates reduction in hazard rate in favor of Talazoparib+Enzalutamide compared to Placebo+Enzalutamide.|The following statistical hypotheses was tested to address the primary objectives: H01: HRrPFS ≥1 vs H11: HRrPFS \<1, where HRrPFS and HRrPFS+ are the hazard ratios (talazoparib in combination with enzalutamide vs. placebo in combination with enzalutamide) of rPFS based on BICR assessment in the all-comers population for Part 2 Cohort 1.||0.777|0.506|<0.0001
72509383|NCT03395197|144549333|SUPERIORITY||Hazard Ratio (HR)|0.447|||<|0.0001|TWO_SIDED|95.0|0.328|0.61||1-sided|Log Rank||Hazard ratio was based on Cox proportional hazards model; under proportional hazards, hazard ratio \< 1 indicates reduction in hazard rate in favor of Talazoparib+Enzalutamide compared to Placebo+Enzalutamide.|The following statistical hypotheses was tested to address the primary objectives: H02: HRrPFS+ ≥1 vs H12: HRrPFS+ \<1, where HRrPFS and HRrPFS+ are the hazard ratios (talazoparib in combination with enzalutamide vs. placebo in combination with enzalutamide) of rPFS based on BICR assessment in the DDR deficient population for Part 2 Cohort 2.||0.610|0.328|<0.0001
72509384|NCT01808118|144549386|OTHER||||||<|0.001||||||2-sided Pearson's chi-square test|Chi-squared|||||||<0.001
72509385|NCT01808118|144549405|OTHER||||||<|0.001|||||||Log Rank|||The statistical test was performed at a 2-sided significance level of 0.05. Time to flare analysis showed statistically significant lower risk of flare in the adalimumab group than in the placebo group.||||<0.001
72509386|NCT03650452|144549431|SUPERIORITY||Hodges-Lehmann Estimation|-30.48||||0.0007|TWO_SIDED|95.0|-46.99|-13.19||The p-value is 2-sided and it is for the difference of percent change from baseline between TAK-935 and Placebo were computed using Rank Transformed Analysis of Covariance (ANCOVA) adjusting for baseline seizure frequency and indication.|Ranked ANCOVA||The location shift (TAK-935 - Placebo) and Asymptotic 95% confidence interval between TAK-935 and Placebo (TAK-935 - Placebo) were based on Hodges-Lehmann Estimation from un-adjusted rank statistics.|||-13.19|-46.99|0.0007
72509387|NCT03650452|144549432|SUPERIORITY||Hodges-Lehmann Estimate|-25.93||||0.0024|TWO_SIDED|95.0|-43.96|-10.69||The p-value is 2-sided and it is for the difference of percent change from baseline between TAK-935 and Placebo were computed using Rank Transformed ANCOVA adjusting for baseline seizure frequency and indication.|Ranked ANCOVA||The location shift (TAK-935 - Placebo) and Asymptotic 95% confidence interval between TAK-935 and Placebo (TAK-935 - Placebo) were based on Hodges-Lehmann Estimation from un-adjusted rank statistics.|||-10.69|-43.96|0.0024
72509388|NCT03650452|144549433|SUPERIORITY||Hodges-Lehmann Estimate|-50.0||||0.0001|TWO_SIDED|95.0|-75.03|-25.09||The p-value is 2-sided and it is for the difference of percent change from baseline between TAK-935 and Placebo were computed using Rank Transformed ANCOVA adjusting for baseline seizure frequency.|Ranked ANCOVA||The location shift (TAK-935 - Placebo) and Asymptotic 95% confidence interval between TAK-935 and Placebo (TAK-935 - Placebo) were based on Hodges-Lehmann Estimation from un-adjusted rank statistics.|||-25.09|-75.03|0.0001
72479407|NCT03486457|144484780|SUPERIORITY||LS mean difference|-0.13|STANDARD_ERROR_OF_MEAN|0.066||0.0537|TWO_SIDED|95.0|-0.26|0.0|||Mixed Models Analysis|||Month 1, Pain/Discomfort: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||0.00|-0.26|0.0537
72509389|NCT03650452|144549434|SUPERIORITY||Hodges-Lehmann Estimate|-16.22||||0.147|TWO_SIDED|95.0|-39.5|4.49||The p-value is 2-sided and it is for the difference of percent change from baseline between TAK-935 and Placebo were computed using Rank Transformed ANCOVA adjusting for baseline seizure frequency.|Ranked ANCOVA||The location shift (TAK-935 - Placebo) and Asymptotic 95% confidence interval between TAK-935 and Placebo (TAK-935 - Placebo) were based on Hodges-Lehmann Estimation from un-adjusted rank statistics.|||4.49|-39.50|0.1470
72509390|NCT03650452|144549437|SUPERIORITY||Least Square (LS) Mean|0.1|STANDARD_DEVIATION|0.21||0.6829|TWO_SIDED|95.0|-0.32|0.49||The p-value is 2-sided and it is for the difference (TAK-935 - Placebo) of change from baseline between TAK-935 and Placebo was computed using MMRM.|Mixed-Model Repeated Measure (MMRM)||The MMRM model included treatment and visit as factors along with treatment\*visit interaction and baseline score as a covariate; and visit as repeated measure.|||0.49|-0.32|0.6829
72509391|NCT02273050|144549442|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.885|STANDARD_ERROR_OF_MEAN|0.0994|<|0.001|TWO_SIDED|95.0|-1.08|-0.689|||ANCOVA|||||-0.689|-1.080|<0.001
72509392|NCT02273050|144549442|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.213|STANDARD_ERROR_OF_MEAN|0.1005||0.034|TWO_SIDED|95.0|-0.41|-0.016|||ANCOVA|||||-0.016|-0.410|0.034
72509393|NCT02273050|144549443|SUPERIORITY_OR_OTHER||Mean Difference (Net)|37.5|||<|0.001|TWO_SIDED|95.0|29.0|46.0|||Fisher Exact|||||46.0|29.0|<0.001
72509394|NCT02273050|144549443|SUPERIORITY_OR_OTHER||Mean Difference (Net)|10.7||||0.011|TWO_SIDED|95.0|2.6|18.9|||Fisher Exact|||||18.9|2.6|0.011
72509395|NCT02273050|144549444|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.39|STANDARD_ERROR_OF_MEAN|0.158|<|0.001|TWO_SIDED|95.0|-1.7|-1.08|||ANCOVA|||||-1.08|-1.70|<0.001
72479408|NCT03486457|144484780|SUPERIORITY||LS mean difference|-0.08|STANDARD_ERROR_OF_MEAN|0.062||0.1977|TWO_SIDED|95.0|-0.2|0.04|||Mixed Models Analysis|||Month 1, Anxiety/Depression: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||0.04|-0.20|0.1977
72479409|NCT03486457|144484780|SUPERIORITY||LS mean difference|-0.25|STANDARD_ERROR_OF_MEAN|0.064||0.0001|TWO_SIDED|95.0|-0.38|-0.13|||Mixed Models Analysis|||Month 3, Mobility: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-0.13|-0.38|0.0001
72479410|NCT03486457|144484780|SUPERIORITY||LS mean difference|-0.18|STANDARD_ERROR_OF_MEAN|0.057||0.0018|TWO_SIDED|95.0|-0.29|-0.07|||Mixed Models Analysis|||Month 3, Self-Care: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-0.07|-0.29|0.0018
72479411|NCT03486457|144484780|SUPERIORITY||LS mean difference|-0.33|STANDARD_ERROR_OF_MEAN|0.07|<|0.0001|TWO_SIDED|95.0|-0.47|-0.19|||Mixed Models Analysis|||Month 3, Usual Activities: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-0.19|-0.47|<0.0001
72479412|NCT03486457|144484780|SUPERIORITY||LS mean difference|-0.28|STANDARD_ERROR_OF_MEAN|0.073||0.0002|TWO_SIDED|95.0|-0.42|-0.14|||Mixed Models Analysis|||Month 3, Pain/Discomfort: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-0.14|-0.42|0.0002
72479413|NCT03486457|144484780|SUPERIORITY||LS mean difference|-0.11|STANDARD_ERROR_OF_MEAN|0.063||0.0835|TWO_SIDED|95.0|-0.23|0.01|||Mixed Models Analysis|||Month 3, Anxiety/Depression: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||0.01|-0.23|0.0835
72479414|NCT03486457|144484780|SUPERIORITY||LS mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.056||0.0825|TWO_SIDED|95.0|-0.21|0.01|||Mixed Models Analysis|||Month 6, Mobility: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||0.01|-0.21|0.0825
72479415|NCT03486457|144484780|SUPERIORITY||LS mean difference|-0.03|STANDARD_ERROR_OF_MEAN|0.049||0.5616|TWO_SIDED|95.0|-0.13|0.07|||Mixed Models Analysis|||Month 6, Self-Care: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||0.07|-0.13|0.5616
72479416|NCT03486457|144484780|SUPERIORITY||LS mean difference|-0.12|STANDARD_ERROR_OF_MEAN|0.065||0.0748|TWO_SIDED|95.0|-0.24|0.01|||Mixed Models Analysis|||Month 6, Usual Activities: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||0.01|-0.24|0.0748
72479417|NCT03486457|144484780|SUPERIORITY||LS mean difference|0.01|STANDARD_ERROR_OF_MEAN|0.08||0.9477|TWO_SIDED|95.0|-0.15|0.16|||Mixed Models Analysis|||Month 6, Pain/Discomfort: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||0.16|-0.15|0.9477
72479418|NCT03486457|144484780|SUPERIORITY||LS mean difference|0.06|STANDARD_ERROR_OF_MEAN|0.067||0.3829|TWO_SIDED|95.0|-0.07|0.19|||Mixed Models Analysis|||Month 6, Anxiety/Depression: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||0.19|-0.07|0.3829
72479419|NCT03486457|144484781|SUPERIORITY||LS mean difference|6.01|STANDARD_ERROR_OF_MEAN|2.084||0.0044|TWO_SIDED|95.0|1.9|10.12|||Mixed Models Analysis|||Month 1: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||10.12|1.90|0.0044
72479420|NCT03486457|144484781|SUPERIORITY||LS mean difference|10.8|STANDARD_ERROR_OF_MEAN|2.578|<|0.0001|TWO_SIDED|95.0|5.71|15.88|||Mixed Models Analysis|||Month 3: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||15.88|5.71|<0.0001
72566577|NCT02985879|144663394|SUPERIORITY|The primary efficacy analysis utilized a likelihood-based, mixed-effects model, repeated measures (MMRM) analysis of the change from baseline for each postbaseline value and compared each ABBV-8E12 dose group with the placebo group. The model, which used all observed data, included fixed, categorical effects for treatment, site, visit, baseline score-by-visit interaction and treatment-by-visit interaction, with continuous fixed covariates for the corresponding baseline score.|LS Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|0.34|=|0.543|TWO_SIDED|95.0|-0.46|0.87|||Mixed-effects model, repeated measures||ABBV-8E12 4000 mg - Placebo|ABBV-8E12 4000 mg vs Placebo||0.87|-0.46|=0.543
72479421|NCT03486457|144484781|SUPERIORITY||LS mean difference|0.92|STANDARD_ERROR_OF_MEAN|2.442||0.7062|TWO_SIDED|95.0|-3.9|5.74|||Mixed Models Analysis|||Month 6: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||5.74|-3.90|0.7062
72479422|NCT03486457|144484782|SUPERIORITY||LS mean difference|0.86|STANDARD_ERROR_OF_MEAN|2.404||0.7228|TWO_SIDED|95.0|-3.92|5.63|||Mixed Models Analysis|||Month 3, Work Time Missed: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||5.63|-3.92|0.7228
72566578|NCT02985879|144663395|SUPERIORITY|The analysis utilized a likelihood-based, mixed-effects model, repeated measures (MMRM) analysis of the change from baseline for each postbaseline value and compared each ABBV-8E12 dose group with the placebo group. The model, which used all observed data, included fixed, categorical effects for treatment, site, visit, baseline score-by-visit interaction and treatment-by-visit interaction, with continuous fixed covariates for the corresponding baseline score.|LS Mean Difference|-5.5|STANDARD_ERROR_OF_MEAN|25.44|=|0.829|TWO_SIDED|95.0|-55.66|44.63|||Mixed-effects model, repeated measures||ABBV-8E12 2000 mg - Placebo|ABBV-8E12 2000 mg vs Placebo||44.63|-55.66|=0.829
72479423|NCT03486457|144484782|SUPERIORITY||LS mean difference|-6.34|STANDARD_ERROR_OF_MEAN|4.561||0.1682|TWO_SIDED|95.0|-15.39|2.72|||Mixed Models Analysis|||Month 3, Impairment While Working: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||2.72|-15.39|0.1682
72479424|NCT03486457|144484782|SUPERIORITY||LS mean difference|-6.21|STANDARD_ERROR_OF_MEAN|4.707||0.19|TWO_SIDED|95.0|-15.56|3.13|||Mixed Models Analysis|||Month 3, Overall Work Impairment: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||3.13|-15.56|0.1900
72400236|NCT02016625|144308273|NON_INFERIORITY_OR_EQUIVALENCE|H0: ratio is outside of interval (80%, 125%) VS H1: ratio is inside of interval (80%, 125%)|gMean ratio (%)|99.15|STANDARD_ERROR_OF_MEAN|28.5||0.0269|TWO_SIDED|90.0|82.857|118.644|||ANOVA||gMean ratio of tac+FDV to FDV treatment. The standard error of the mean actually is the geometric coefficient of variation (%).|gMean ratio of tac+FDV to FDV treatment. The statistical model used for the analysis of primary endpoints was an analysis of variance (ANOVA) model on the logarithmic scale. This model accounted for variation from 'subject' and 'treatment' effects. The 'subject' effect was considered to be random, whereas the 'treatment' effect was considered as fixed.||118.644|82.857|0.0269
72479425|NCT03486457|144484782|SUPERIORITY||LS mean difference|-1.08|STANDARD_ERROR_OF_MEAN|2.581||0.6757|TWO_SIDED|95.0|-6.22|4.05|||Mixed Models Analysis|||Month 6, Work Time Missed: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||4.05|-6.22|0.6757
72400237|NCT02016625|144308274|NON_INFERIORITY_OR_EQUIVALENCE|H0: ratio is outside of interval (80%, 125%) VS H1: ratio is inside of interval (80%, 125%)|gMean ratio (%)|93.85|STANDARD_ERROR_OF_MEAN|25.1||0.0493|TWO_SIDED|90.0|80.059|110.022|||ANOVA||gMean ratio of tac+FDV to FDV treatment. The standard error of the mean actually is the geometric coefficient of variation (%).|gMean ratio of tac+FDV to FDV treatment. The statistical model used for the analysis of primary endpoints was an analysis of variance (ANOVA) model on the logarithmic scale. This model accounted for variation from 'subject' and 'treatment' effects. The 'subject' effect was considered to be random, whereas the 'treatment' effect was considered as fixed.||110.022|80.059|0.0493
72400238|NCT02016625|144308275|NON_INFERIORITY_OR_EQUIVALENCE|H0: ratio is outside of interval (80%, 125%) VS H1: ratio is inside of interval (80%, 125%)|gMean ratio (%)|99.54|STANDARD_ERROR_OF_MEAN|10.0||0|TWO_SIDED|90.0|93.375|106.115|||ANOVA||gMean ratio of tac+FDV to FDV treatment. The standard error of the mean actually is the geometric coefficient of variation (%).|gMean ratio of tac+FDV to FDV treatment. The statistical model used for the analysis of primary endpoints was an analysis of variance (ANOVA) model on the logarithmic scale. This model accounted for variation from 'subject' and 'treatment' effects. The 'subject' effect was considered to be random, whereas the 'treatment' effect was considered as fixed.||106.115|93.375|0.0000
72400239|NCT02016625|144308276|NON_INFERIORITY_OR_EQUIVALENCE|H0: ratio is outside of interval (80%, 125%) VS H1: ratio is inside of interval (80%, 125%)|gMean ratio (%)|96.16|STANDARD_ERROR_OF_MEAN|12.9||0.0008|TWO_SIDED|90.0|88.53|104.45|||ANOVA||gMean ratio of tac+FDV to FDV treatment. The standard error of the mean actually is the geometric coefficient of variation (%).|gMean ratio of tac+FDV to FDV treatment. The statistical model used for the analysis of primary endpoints was an analysis of variance (ANOVA) model on the logarithmic scale. This model accounted for variation from 'subject' and 'treatment' effects. The 'subject' effect was considered to be random, whereas the 'treatment' effect was considered as fixed.||104.45|88.53|0.0008
72400240|NCT00887354|144308277|SUPERIORITY_OR_OTHER_LEGACY||LS Mean|0.04|||<|0.0001|TWO_SIDED|95.0|0.025|0.055|||Mixed Models Analysis|||||0.055|0.025|<.0001
72479426|NCT03486457|144484782|SUPERIORITY||LS mean difference|-2.38|STANDARD_ERROR_OF_MEAN|4.905||0.6285|TWO_SIDED|95.0|-12.13|7.37|||Mixed Models Analysis|||Month 6, Impairment While Working: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||7.37|-12.13|0.6285
72479427|NCT03486457|144484782|SUPERIORITY||LS mean difference|-2.63|STANDARD_ERROR_OF_MEAN|5.333||0.6228|TWO_SIDED|95.0|-13.23|7.97|||Mixed Models Analysis|||Month 6, Overall Work Impairment: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||7.97|-13.23|0.6228
72479428|NCT03486457|144484783|SUPERIORITY||LS mean difference|-12.81|STANDARD_ERROR_OF_MEAN|3.089|<|0.0001|TWO_SIDED|95.0|-18.9|-6.72|||Mixed Models Analysis|||Month 3, Activity Impairment: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-6.72|-18.90|<0.0001
72400241|NCT04608500|144308300|SUPERIORITY||Mean Difference (Final Values)|3.85|STANDARD_ERROR_OF_MEAN|0.861|<|0.0001|TWO_SIDED|95.0|2.16|5.54|||ANCOVA|Analysis of covariance (ANCOVA) model includes treatment, Baseline inflammatory lesion count, and analysis center.||||5.54|2.16|<0.0001
72479429|NCT03486457|144484783|SUPERIORITY||LS mean difference|1.06|STANDARD_ERROR_OF_MEAN|3.157||0.7384|TWO_SIDED|95.0|-5.17|7.28|||Mixed Models Analysis|||Month 6, Activity Impairment: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||7.28|-5.17|0.7384
72479430|NCT00372229|144484784|SUPERIORITY_OR_OTHER_LEGACY||Difference|-28.5|STANDARD_ERROR_OF_MEAN|5.45|||TWO_SIDED|96.0|-39.7|-17.3||||||||-17.3|-39.7|
72479431|NCT00372229|144484785|SUPERIORITY_OR_OTHER_LEGACY||Difference|-11.3|STANDARD_ERROR_OF_MEAN|3.83|||TWO_SIDED|96.0|-19.2|-3.4||||||||-3.4|-19.2|
72479432|NCT00372229|144484786|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.2509|STANDARD_ERROR_OF_MEAN|0.1838||0.1739|TWO_SIDED|99.0|-0.2271|0.7289|||F-test|||||0.7289|-0.2271|0.1739
72479433|NCT00372229|144484819|OTHER|Descriptive analysis|Mean Difference (Final Values)|-3.2|STANDARD_ERROR_OF_MEAN|8.71|||TWO_SIDED|95.0|-20.2|13.9||||||||13.9|-20.2|
72509396|NCT02273050|144549444|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.32|STANDARD_ERROR_OF_MEAN|0.159||0.046|TWO_SIDED|95.0|-0.63|0.0|||ANCOVA|||||0.00|-0.63|0.046
72479434|NCT00372229|144484820|OTHER|Descriptive analysis|Mean Difference (Final Values)|12.1|STANDARD_ERROR_OF_MEAN|6.21|||TWO_SIDED|95.0|-0.1|24.2||||||||24.2|-0.1|
72479435|NCT02943226|144484838|SUPERIORITY|||||||0.4487|||||||two sample t-test|||||||0.4487
72479436|NCT02943226|144484839|SUPERIORITY|||||||0.0112|||||||Wilcoxon (Mann-Whitney)|||||||0.0112
72479437|NCT02943226|144484840|SUPERIORITY|||||||0.0784|||||||two sample t-test|||||||0.0784
72479438|NCT01602562|144484841|SUPERIORITY_OR_OTHER||percentage of participants|0.0|||||TWO_SIDED|95.0|0.0|16.11|||||The estimated value reflects the percentage of participants with an HSV infection.|||16.11|0.00|
72479439|NCT01602562|144484841|SUPERIORITY_OR_OTHER||percentage of participants|0.0|||||TWO_SIDED|95.0|0.0|17.65|||||The estimated value reflects the percentage of participants with an HSV infection.|||17.65|0.00|
72479440|NCT03881553|144484856|OTHER|Non-parametric Friedmans||||||0.081||||||χ2 =5.03|Friedman's|||||||0.081
72479441|NCT03881553|144484856|OTHER|Post hoc: Wilcoxon||||||0.05||||||ON1 compared to OFF1|Wilcoxon (Mann-Whitney)|||||||0.05
72479442|NCT03881553|144484856|OTHER|Post Hoc Wilcoxon||||||0.021||||||ON1 compared to OFF2|Wilcoxon (Mann-Whitney)|||||||0.021
72400242|NCT04608500|144308301|SUPERIORITY||Risk Ratio (RR)|1.263||||0.0077|TWO_SIDED|95.0|1.064|1.499||The p-value is for the null hypothesis that the combined risk ratio equals 1.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by analysis center.||||1.499|1.064|0.0077
72400243|NCT04608500|144308302|SUPERIORITY||Risk Ratio (RR)|1.193||||0.0189|TWO_SIDED|95.0|1.024|1.39||The p-value is for the null hypothesis that the combined risk ratio equals 1.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel Test Stratified by Analysis Center||||1.390|1.024|0.0189
72400244|NCT04608500|144308303|SUPERIORITY||Mean Difference (Final Values)|11.3|STANDARD_ERROR_OF_MEAN|2.672|<|0.0001|TWO_SIDED|95.0|6.05|16.54|||ANCOVA|ANCOVA model includes treatment, Baseline inflammatory lesion count, and analysis center.||||16.54|6.05|<0.0001
72479443|NCT04217590|144484977|SUPERIORITY||Odds Ratio (OR)|5.1|||<|0.001|TWO_SIDED|95.0|1.9|15.12|||Fisher Exact||The CI for OR is calculated as an exact CI. An OR \> 1 favours SZC.|||15.12|1.90|<0.001
72479444|NCT04217590|144484978|SUPERIORITY||Odds Ratio (OR)|6.41|||<|0.001|TWO_SIDED|95.0|2.64|15.55|||Regression, Logistic|The OR, 95% CI and p-value are obtained from a pooled logistic regression model after multiple imputation (MI) of missing pre-dialysis S-K values.|An OR \> 1 favours SZC.|||15.55|2.64|<0.001
72479445|NCT04217590|144484979|SUPERIORITY||Odds Ratio (OR)|6.41|||<|0.001|TWO_SIDED|95.0|2.71|15.12|||Regression, Logistic|The OR, 95% CI and p-value are obtained from a pooled logistic regression model after multiple imputation (MI) of missing pre-dialysis S-K values.|An OR \> 1 favours SZC.|||15.12|2.71|<0.001
72479446|NCT04217590|144484980|SUPERIORITY||Odds Ratio (OR)|4.41|||<|0.001|TWO_SIDED|95.0|2.53|7.67|||Generalised linear mixed model (GLMM)|The p-value was obtained from a test of equality of odds ratios.|The OR was obtained from GLMM model with random intercept and logit link. Treatment, visit, visit by treatment interaction and baseline were specified as fixed effects. An OR \> 1 favours SZC.|||7.67|2.53|<0.001
72479447|NCT04217590|144484981|SUPERIORITY||Mean Difference (Final Values)|1.2|||||TWO_SIDED|95.0|0.77|1.64|||||Endpoint analysed with Generalised linear mixed model. The CI for the mean difference was calculated by bootstrapping. A mean difference \> 0 favours SZC.|||1.64|0.77|
72479448|NCT04217590|144484982|SUPERIORITY||Odds Ratio (OR)|5.82|||<|0.001|TWO_SIDED|95.0|3.15|10.73|||Generalised linear mixed model (GLMM)|The p-value was obtained from a test of equality of odds ratios.|The OR was obtained from GLMM model with random intercept and logit link. Treatment, visit, visit by treatment interaction and baseline were specified as fixed effects. An OR \> 1 favours SZC.|||10.73|3.15|<0.001
72479449|NCT04619251|144484984|OTHER|Since the main focus is on estimation and not testing, a formal hypothesis test and associated acceptance range is not specified.|Geometric Least Squares Mean ratio (%)|337.6|||||TWO_SIDED|90.0|302.8|376.4|||||Geometric Least Squares Mean ratio was estimated by the ratios of the geometric means (T/R). Intra-individual geometric coefficient variation (gCV %) =15.9|The PK endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model. This model included effects accounting for the following sources of variation: subject and treatment. The effect 'subject' was considered as random, whereas the effect 'treatment' was considered as fixed. These quantities were then back-transformed to the original scale.||376.4|302.8|
72479450|NCT04619251|144484985|OTHER|Since the main focus is on estimation and not testing, a formal hypothesis test and associated acceptance range is not specified.|Geometric Least Squares Mean ratio (%)|184.4|||||TWO_SIDED|90.0|156.0|218.0|||||Geometric Least Squares Mean ratio was estimated by the ratios of the geometric means (T/R). Intra-individual geometric coefficient variation (gCV %) =26.4|The PK endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model. This model included effects accounting for the following sources of variation: subject and treatment. The effect 'subject' was considered as random, whereas the effect 'treatment' was considered as fixed. These quantities were then back-transformed to the original scale.||218.0|156.0|
72400245|NCT04608500|144308304|SUPERIORITY||Mean Difference (Final Values)|4.38|STANDARD_ERROR_OF_MEAN|0.821|<|0.0001|TWO_SIDED|95.0|2.77|5.99|||ANCOVA|ANCOVA model includes treatment, Baseline inflammatory lesion count, and analysis center.||Statistical Analysis For Week 4||5.99|2.77|<0.0001
72400246|NCT04608500|144308304|SUPERIORITY||Mean Difference (Final Values)|5.07|STANDARD_ERROR_OF_MEAN|0.793|<|0.0001|TWO_SIDED|95.0|3.52|6.63|||ANCOVA|ANCOVA model includes treatment, Baseline inflammatory lesion count, and analysis center.||Statistical Analysis For Week 8||6.63|3.52|<0.0001
72479451|NCT04619251|144484986|OTHER|Since the main focus is on estimation and not testing, a formal hypothesis test and associated acceptance range is not specified.|Geometric Least Squares Mean ratio (%)|356.8|||||TWO_SIDED|90.0|315.7|403.2|||||Geometric Least Squares Mean ratio was estimated by the ratios of the geometric means (T/R). Intra-individual geometric coefficient variation (gCV %) =18.4|The PK endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model. This model included effects accounting for the following sources of variation: subject and treatment. The effect 'subject' was considered as random, whereas the effect 'treatment' was considered as fixed. These quantities were then back-transformed to the original scale.||403.2|315.7|
72479452|NCT00803751|144484995|SUPERIORITY_OR_OTHER|||||||0.17||95.0|||||Fisher Exact|||||||0.17
72509397|NCT02273050|144549445|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-416.0|STANDARD_ERROR_OF_MEAN|51.54|<|0.001|TWO_SIDED|95.0|-517.3|-314.6|||ANCOVA|||||-314.6|-517.3|<0.001
72400247|NCT04608500|144308305|SUPERIORITY||Risk Ratio (RR)|1.715||||0.0114|TWO_SIDED|95.0|1.129|2.605||p-value is for the null hypothesis that the risk ratio equals 1.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by analysis center.||Statistical Analysis For Week 4||2.605|1.129|0.0114
72400248|NCT04608500|144308305|SUPERIORITY||Risk Ratio (RR)|1.319||||0.0061|TWO_SIDED|95.0|1.082|1.607||p-value is for the null hypothesis that the risk ratio equals 1.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by analysis center.||Statistical Analysis For Week 8||1.607|1.082|0.0061
72400249|NCT00914810|144308312|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.3||||0.55|TWO_SIDED|95.0|-0.8|1.5|||t-test, 2 sided|||||1.5|-0.8|0.55
72479453|NCT00803751|144484996|SUPERIORITY_OR_OTHER|||||||0.45||95.0|||||Fisher Exact|||||||0.45
72479454|NCT00803751|144484997|SUPERIORITY_OR_OTHER|||||||0.36||95.0|||||t-test, 2 sided|||||||0.36
72479455|NCT00803751|144484998|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||t-test, 2 sided|||||||0.002
72479456|NCT00803751|144484999|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Fisher Exact|||||||<0.001
72479457|NCT00803751|144485000|SUPERIORITY_OR_OTHER|||||||0.0004||95.0|||||t-test, 2 sided|||||||0.0004
72479458|NCT03102645|144485005|SUPERIORITY||Mean Difference (Final Values)|6.5||||0.07|TWO_SIDED|95.0|-0.5|13.5|||t-test, 2 sided|CROS. DF=14.||CROS test||13.5|-0.5|0.07
72479459|NCT03102645|144485006|SUPERIORITY||Mean Difference (Final Values)|15.2||||0.03|TWO_SIDED|95.0|2.0|28.2|||t-test, 2 sided|CROS test||CROS test||28.2|2.0|0.03
72479460|NCT01413087|144485007|SUPERIORITY|||||||0.483|||||||Log Rank|P value by log-rank test for the difference between treatment groups||||||0.483
72479461|NCT01413087|144485008|SUPERIORITY|||||||0.992|||||||Log Rank|P value by log-rank test for the difference between treatment groups||||||0.992
72479462|NCT00998335|144485036|SUPERIORITY_OR_OTHER|||||||0.03|TWO_SIDED||||||ANOVA|||Baseline versus 3 months||||0.03
72479463|NCT02390050|144485068|SUPERIORITY||Difference of LS Means|-0.55|||<|0.0001|TWO_SIDED|95.0|-0.76|-0.34||P-value from Type III F-test|ANCOVA|Study center, treatment, visit and a treatment-by-visit interaction as fixed effects; prior anti-diabetic treatment and baseline HbA1c as covariates||||-0.34|-0.76|< 0.0001
72509398|NCT02273050|144549445|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-169.3|STANDARD_ERROR_OF_MEAN|52.05||0.001|TWO_SIDED|95.0|-271.7|-66.9|||ANCOVA|||||-66.9|-271.7|0.001
72509399|NCT02273050|144549446|SUPERIORITY_OR_OTHER||Mean Difference (Net)|34.9|||<|0.001|TWO_SIDED|95.0|26.0|43.9|||Fisher Exact|||||43.9|26.0|<0.001
72576854|NCT00261443|144680662|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.07||||0.637|TWO_SIDED|95.0|-0.39|0.24||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 40 Comparison||0.24|-0.39|0.637
72400250|NCT00914810|144308313|SUPERIORITY_OR_OTHER||Mean Difference (Net)|10.5|||<|0.0001|TWO_SIDED|95.0|7.4|13.6|||t-test, 2 sided|||||13.6|7.4|<0.0001
72479464|NCT02390050|144485068|SUPERIORITY||Difference of LS Means|-0.68|||<|0.0001|TWO_SIDED|95.0|-0.89|-0.47||P-value from Type III F-test|ANCOVA|Study center, treatment, visit and a treatment-by-visit interaction as fixed effects; prior anti-diabetic treatment and baseline HbA1c as covariates||||-0.47|-0.89|< 0.0001
72479465|NCT02390050|144485068|SUPERIORITY||Difference of LS Means|-0.8|||<|0.0001|TWO_SIDED|95.0|-1.01|-0.59||P-value from Type III F-test|ANCOVA|Study center, treatment, visit and a treatment-by-visit interaction as fixed effects; prior anti-diabetic treatment and baseline HbA1c as covariates||||-0.59|-1.01|< 0.0001
72479466|NCT02390050|144485069|SUPERIORITY||Odds Ratio (OR)|2.1||||0.1308|TWO_SIDED|95.0|0.8|5.3|||Regression, Logistic|Treatment, country, baseline HbA1c and prior anti-diabetic treatment status as predictor variables and a dependable variable of 1 (\<7%) or 0 (\>7%).||Odds ratio of having at least 1 post-baseline HbA1c value \<7% in the 5 mg bexagliflozin group was compared to placebo group.||5.3|0.8|0.1308
72479467|NCT02390050|144485069|SUPERIORITY||Odds Ratio (OR)|2.0||||0.1294|TWO_SIDED|95.0|0.8|5.1|||Regression, Logistic|Treatment, country, baseline HbA1c and prior anti-diabetic treatment status as predictor variables and a dependable variable of 1 (\<7%) or 0 (\>7%).||Odds ratio of having at least 1 post-baseline HbA1c value \<7% in the 10 mg bexagliflozin group was compared to placebo group.||5.1|0.8|0.1294
72479468|NCT02390050|144485069|SUPERIORITY||Odds Ratio (OR)|4.2||||0.0015|TWO_SIDED|95.0|1.7|10.3|||Regression, Logistic|Treatment, country, baseline HbA1c and prior anti-diabetic treatment status as predictor variables and a dependable variable of 1 (\<7%) or 0 (\>7%).||Odds ratio of having at least 1 post-baseline HbA1c value \<7% in the 20 mg bexagliflozin group was compared to placebo group.||10.3|1.7|0.0015
72479469|NCT02390050|144485070|SUPERIORITY||Difference of LS Means|-0.74|||||TWO_SIDED|95.0|-1.13|-0.36||||||Week 2: Difference in LS mean change in body weight from baseline to week 2 was obtained by comparing Bexagliflozin 5 mg group and Placebo group||-0.36|-1.13|
72479470|NCT02390050|144485070|SUPERIORITY||Difference of LS Means|-0.76|||||TWO_SIDED|95.0|-1.15|-0.38||||||Week 2: Difference in LS mean change in body weight from baseline to week 2 was obtained by comparing Bexagliflozin 10 mg group and Placebo group||-0.38|-1.15|
72479471|NCT02390050|144485070|SUPERIORITY||Difference of LS Means|-0.99|||||TWO_SIDED|95.0|-1.38|-0.61||||||Week 2: Difference in LS mean change in body weight from baseline to week 2 was obtained by comparing Bexagliflozin 20 mg group and Placebo group||-0.61|-1.38|
72479472|NCT02390050|144485070|SUPERIORITY||Difference of LS Means|-1.02|||||TWO_SIDED|95.0|-1.53|-0.52||||||Week 6: Difference in LS mean change in body weight from baseline to week 6 was obtained by comparing Bexagliflozin 5 mg group and Placebo group||-0.52|-1.53|
72479473|NCT02390050|144485070|SUPERIORITY||Difference of LS Means|-1.45|||||TWO_SIDED|95.0|-1.95|-0.94||||||Week 6: Difference in LS mean change in body weight from baseline to week 6 was obtained by comparing Bexagliflozin 10 mg group and Placebo group||-0.94|-1.95|
72509400|NCT02273050|144549446|SUPERIORITY_OR_OTHER||Mean Difference (Net)|11.6||||0.02|TWO_SIDED|95.0|2.3|20.9|||Fisher Exact|||||20.9|2.3|0.020
72509401|NCT02273050|144549447|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.97|STANDARD_ERROR_OF_MEAN|0.37|<|0.001|TWO_SIDED|95.0|-3.7|-2.25|||ANCOVA|||||-2.25|-3.70|<0.001
72509402|NCT02273050|144549447|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.14|STANDARD_ERROR_OF_MEAN|0.374||0.002|TWO_SIDED|95.0|-1.88|-0.41|||ANCOVA|||||-0.41|-1.88|0.002
72509403|NCT02273050|144549448|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-8.9|||<|0.001|TWO_SIDED|95.0|-13.3|-4.5|||Fisher Exact|||||-4.5|-13.3|<0.001
72509404|NCT02273050|144549448|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0|||>|0.999|TWO_SIDED|95.0|-2.3|2.3|||Fisher Exact|||||2.3|-2.3|>0.999
72509405|NCT02042404|144549449|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||repeated measures ANOVA|||||||<0.0001
72509406|NCT02042404|144549450|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||repeated measures ANOVA|||||||<0.0001
72509407|NCT02042404|144549451|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||repeated measures ANOVA|||||||<0.0001
72400251|NCT01327300|144308319|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.72||||0.001||95.0|||||t-test, 2 sided|||"The GIS scoring system is from 1-7 with one being a worse outcome and 7 the better outcome.~Comparisons below list the p values for comparison of difference in GIS between baseline and mesalamine."||||.001
72509408|NCT02042404|144549452|SUPERIORITY_OR_OTHER|||||||0.0281|TWO_SIDED||||||repeated measures ANOVA|||||||0.0281
72509409|NCT05692154|144549589|SUPERIORITY||Least Square Mean Difference|-4.24|STANDARD_ERROR_OF_MEAN|2.015||0.038|TWO_SIDED|95.0|-8.24|-0.23|||ANCOVA||Least-squares means, standard errors and p-value are taken from an analysis of covariance model, with treatment group as fixed effect and baseline TNSS (H0 at Visit 4) as covariate.|||-0.23|-8.24|0.038
72509410|NCT05692154|144549590|SUPERIORITY||Least Square Mean Difference|-4.75|STANDARD_ERROR_OF_MEAN|2.088||0.025|TWO_SIDED|95.0|-8.9|-0.6|||ANCOVA||Least-squares means, standard errors and p-value are taken from an analysis of covariance, with treatment group as fixed categorical effect and baseline TOSS (H0 at Visit 4) as covariate.|||-0.60|-8.90|0.025
72509411|NCT05692154|144549591|SUPERIORITY||Least Square Mean Difference|-6.5|STANDARD_ERROR_OF_MEAN|3.247||0.048|TWO_SIDED|95.0|-12.95|-0.05|||ANCOVA||Least-squares means, standard errors and p-value are taken from an analysis of covariance model, with treatment group as fixed effect and baseline TNSS (H0 at Visit 4) as covariate.|||-0.05|-12.95|0.048
72509412|NCT05692154|144549592|SUPERIORITY||Least Square Mean Difference|-7.47|STANDARD_ERROR_OF_MEAN|2.89||0.011|TWO_SIDED|95.0|-13.21|-1.73|||ANCOVA||Least-squares means, standard errors and p-value are taken from an analysis of covariance, with treatment group as fixed categorical effect and baseline TOSS (H0 at Visit 4) as covariate.|||-1.73|-13.21|0.011
72509413|NCT05692154|144549593|SUPERIORITY||Least Square Mean Difference|-18.45|STANDARD_ERROR_OF_MEAN|10.211||0.074|TWO_SIDED|95.0|-38.74|1.83|||ANCOVA||Least-squares means, standard errors and p-value are taken from an analysis of covariance, with treatment group as fixed categorical effect and baseline TNSS (Day 1) as covariate.|||1.83|-38.74|0.074
72509414|NCT05692154|144549594|SUPERIORITY||Least Square Mean Difference|-4.06|STANDARD_ERROR_OF_MEAN|11.672||0.729|TWO_SIDED|95.0|-27.24|19.12|||ANCOVA||Least-squares means, standard errors and p-value are taken from an analysis of covariance, with treatment group as fixed categorical effect and baseline TOSS (H0 at Day 1) as covariate.|||19.12|-27.24|0.729
72623644|NCT00600340|144778107|SUPERIORITY||Odds Ratio (OR)|0.43||||0.0006|TWO_SIDED|95.0|0.27|0.7||"Test adjusted by stratification factors at randomization:~1. estrogen and/or progesterone status (positive vs. other)~2. country~3. menopausal status (premenopausal or male \<=50 years of age vs. postmenopausal or male \>50 years of age"|Cochran-Mantel-Haenszel||OR is the odds for disease control of Bevacizumab Plus Capecitabine divided by the odds for disease control of Bevacizumab plus Paclitaxel|OR of disease control and CMH test (stratified)||0.70|0.27|0.0006
72400252|NCT01327300|144308319|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.22||||0.008||95.0|||||t-test, 2 sided|||Comparisons of mean difference in GIS scores between baseline and placebo is made below.||||0.008
72509415|NCT01519245|144549598|SUPERIORITY_OR_OTHER|||||||0.0493||95.0|||||t-test, 2 sided|||Intention to Treat principles of data analysis were applied. The two-sided T-test (95% confidence interval) was used for statistical calculation of primary outcomes. The null hypothesis was that no difference in chest tube losses would be found between the topical tranexamic acid and placebo groups in low-risk cardiac patients undergoing CABG.||||0.0493
72509416|NCT01519245|144549600|SUPERIORITY_OR_OTHER|||||||0.1876||95.0|||||t-test, 2 sided|||Intention to Treat principles of data analysis were applied. The two-sided T-test (95% confidence interval) was used for statistical calculation of secondary outcomes. The null hypothesis was that no difference in chest tube losses would be found between the topical tranexamic acid and placebo groups in low-risk cardiac patients undergoing CABG.||||0.1876
72509417|NCT01519245|144549601|SUPERIORITY_OR_OTHER|||||||0.093||95.0|||||t-test, 2 sided|||Intention to Treat principles of data analysis were applied. The two-sided T-test (95% confidence interval) was used for statistical calculation of secondary outcomes. The null hypothesis was that no difference in chest tube losses would be found between the topical tranexamic acid and placebo groups in low-risk cardiac patients undergoing CABG.||||0.0930
72509418|NCT00783705|144549650|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.4||||0.39|TWO_SIDED|95.0|0.7|3.0|||Generalized estimating equation model|||Generalized estimating equation model on lesions (progressive disease vs. complete response/stable disease) was used to account for intra-patient correlation in the lesion-specific analysis.||3.0|0.7|0.39
72509419|NCT00783705|144549654|SUPERIORITY_OR_OTHER|||||||0.1|TWO_SIDED||||||Wilcoxon Rank-Sum|||Comparison of the median difference in biomarker CC-16 level between arms.||||0.10
72509420|NCT00783705|144549655|SUPERIORITY_OR_OTHER|||||||0.03|TWO_SIDED||||||Wilcoxon Rank-Sum|||Comparison of the median difference in biomarker IL-6 level between arms.||||0.03
72509421|NCT00783705|144549656|SUPERIORITY_OR_OTHER|||||||0.58|TWO_SIDED||||||Wilcoxon Rank-Sum|||Comparison of the median difference in biomarker CCL-2 level between arms.||||0.58
72509422|NCT00783705|144549657|SUPERIORITY_OR_OTHER|||||||0.06|TWO_SIDED||||||Wilcoxon Rank-Sum|||Comparison of the median difference in biomarker MPO level between arms.||||0.06
72509423|NCT00783705|144549658|SUPERIORITY_OR_OTHER|||||||0.63|TWO_SIDED||||||Wilcoxon Rank-Sum|||Comparison of the median difference in biomarker CC18 level between arms.||||0.63
72509424|NCT00783705|144549659|SUPERIORITY_OR_OTHER|||||||0.22|TWO_SIDED||||||Wilcoxon Rank-Sum|||Comparison of the median difference in biomarker SFTPD level between arms.||||0.22
72509425|NCT00783705|144549660|SUPERIORITY_OR_OTHER|||||||0.06|TWO_SIDED||||||Wilcoxon Rank-Sum|||Comparison of the median difference in biomarker Total Glutathione level between arms.||||0.06
72509426|NCT00783705|144549661|SUPERIORITY_OR_OTHER|||||||0.35|TWO_SIDED||||||Wilcoxon Rank-Sum|||Comparison of the median difference in biomarker CC-16 level between arms.||||0.35
72509427|NCT00783705|144549662|SUPERIORITY_OR_OTHER|||||||0.8|TWO_SIDED||||||Wilcoxon Rank-Sum|||Comparison of the median difference in biomarker CRP level between arms.||||0.80
72509428|NCT00783705|144549663|SUPERIORITY_OR_OTHER|||||||0.22|TWO_SIDED||||||Wilcoxon Rank-Sum|||Comparison of the median difference in biomarker IL-6 level between arms.||||0.22
72509429|NCT00783705|144549664|SUPERIORITY_OR_OTHER|||||||0.74|TWO_SIDED||||||Wilcoxon Rank-Sum|||Comparison of the median difference in biomarker CCL-2 level between arms.||||0.74
72509430|NCT00783705|144549665|SUPERIORITY_OR_OTHER|||||||0.55|TWO_SIDED||||||Wilcoxon Rank-Sum|||Comparison of the median difference in biomarker MPO level between arms.||||0.55
72479474|NCT02390050|144485070|SUPERIORITY||Difference of LS Means|-1.51|||||TWO_SIDED|95.0|-2.01|-1.01||||||Week 6: Difference in LS mean change in body weight from baseline to week 6 was obtained by comparing Bexagliflozin 20 mg group and Placebo group||-1.01|-2.01|
72479475|NCT02390050|144485070|SUPERIORITY||Difference of LS Means|-1.44|||<|0.0001|TWO_SIDED|95.0|-2.12|-0.76||P-value from Type III F-test|ANCOVA|Study center, treatment, visit and a treatment-by-visit interaction as fixed effects; prior anti-diabetic treatment and baseline weight as covariates||Week 12: Difference in LS mean change in body weight from baseline to week 12 was obtained by comparing Bexagliflozin 5 mg group and Placebo group||-0.76|-2.12|< 0.0001
72566579|NCT02985879|144663395|SUPERIORITY|The analysis utilized a likelihood-based, mixed-effects model, repeated measures (MMRM) analysis of the change from baseline for each postbaseline value and compared each ABBV-8E12 dose group with the placebo group. The model, which used all observed data, included fixed, categorical effects for treatment, site, visit, baseline score-by-visit interaction and treatment-by-visit interaction, with continuous fixed covariates for the corresponding baseline score.|LS Mean Difference|-32.9|STANDARD_ERROR_OF_MEAN|25.92|=|0.206|TWO_SIDED|95.0|-83.94|18.23|||Mixed-effects model, repeated measures||ABBV-8E12 4000 mg - Placebo|ABBV-8E12 4000 mg vs Placebo||18.23|-83.94|=0.206
72479476|NCT02390050|144485070|SUPERIORITY||Difference of LS Means|-1.59|||<|0.0001|TWO_SIDED|95.0|-2.26|-0.91||P-value from Type III F-test|ANCOVA|Study center, treatment, visit and a treatment-by-visit interaction as fixed effects; prior anti-diabetic treatment and baseline weight as covariates||Week 12: Difference in LS mean change in body weight from baseline to week 12 was obtained by comparing Bexagliflozin 10 mg group and Placebo group||-0.91|-2.26|< 0.0001
72479477|NCT02390050|144485070|SUPERIORITY||Difference of LS Means|-1.75|||<|0.0001|TWO_SIDED|95.0|-2.43|-1.08||P-value from Type III F-test|ANCOVA|Study center, treatment, visit and a treatment-by-visit interaction as fixed effects; prior anti-diabetic treatment and baseline weight as covariates||Week 12: Difference in LS mean change in body weight from baseline to week 12 was obtained by comparing Bexagliflozin 20 mg group and Placebo group||-1.08|-2.43|< 0.0001
72479478|NCT02390050|144485071|SUPERIORITY||Difference of LS Means|-0.48|||||TWO_SIDED|95.0|-0.9|-0.06||||||Week 2: Difference in LS mean change in FPG from baseline to week 2 was obtained by comparing Bexagliflozin 5 mg group and Placebo group||-0.06|-0.90|
72479479|NCT02390050|144485071|SUPERIORITY||Difference of LS Means|-0.9|||||TWO_SIDED|95.0|-1.31|-0.48||||||Week 2: Difference in LS mean change in FPG from baseline to week 2 was obtained by comparing Bexagliflozin 10 mg group and Placebo group||-0.48|-1.31|
72479480|NCT02390050|144485071|SUPERIORITY||Difference of LS Means|-1.04|||||TWO_SIDED|95.0|-1.45|-0.62||||||Week 2: Difference in LS mean change in FPG from baseline to week 2 was obtained by comparing Bexagliflozin 20 mg group and Placebo group||-0.62|-1.45|
72479481|NCT02390050|144485071|SUPERIORITY||Difference of LS Means|-0.93|||||TWO_SIDED|95.0|-1.39|-0.48||||||Week 6: Difference in LS mean change in FPG from baseline to week 6 was obtained by comparing Bexagliflozin 5 mg group and Placebo group||-0.48|-1.39|
72479482|NCT02390050|144485071|SUPERIORITY||Difference of LS Means|-1.17|||||TWO_SIDED|95.0|-1.62|-0.72||||||Week 6: Difference in LS mean change in FPG from baseline to week 6 was obtained by comparing Bexagliflozin 10 mg group and Placebo group||-0.72|-1.62|
72479483|NCT02390050|144485071|SUPERIORITY||Difference of LS Means|-1.1|||||TWO_SIDED|95.0|-1.55|-0.65||||||Week 6: Difference in LS mean change in FPG from baseline to week 6 was obtained by comparing Bexagliflozin 20 mg group and Placebo group||-0.65|-1.55|
72479484|NCT02390050|144485071|SUPERIORITY||Difference of LS Means|-0.85||||0.0002|TWO_SIDED|95.0|-1.29|-0.41||P-value from Type III F-test|ANCOVA|Study center, treatment, visit and a treatment-by-visit interaction as fixed effects; prior anti-diabetic treatment and baseline FPG as covariates||Week 12: Difference in LS mean change in FPG from baseline to week 12 was obtained by comparing Bexagliflozin 5 mg group and Placebo group||-0.41|-1.29|0.0002
72479485|NCT02390050|144485071|SUPERIORITY||Difference of LS Means|-1.05|||<|0.0001|TWO_SIDED|95.0|-1.49|-0.6||P-value from Type III F-test|ANCOVA|Study center, treatment, visit and a treatment-by-visit interaction as fixed effects; prior anti-diabetic treatment and baseline FPG as covariates||Week 12: Difference in LS mean change in FPG from baseline to week 12 was obtained by comparing Bexagliflozin 10 mg group and Placebo group||-0.60|-1.49|< 0.0001
72623645|NCT00600340|144778107|SUPERIORITY||Risk Difference (RD)|-12.0|||||TWO_SIDED|95.0|-18.0|-6.0|||||Difference calculated as DCR in Bevacizumab Plus Capecitabine minus DCR in Bevacizumab plus Paclitaxel, units in percent.|Difference in DCR in Bevacizumab Plus Capecitabine vs. Bevacizumab plus Paclitaxel||-6|-18|
72479486|NCT02390050|144485071|SUPERIORITY||Difference of LS Means|-1.07|||<|0.0001|TWO_SIDED|95.0|-1.52|-0.63||P-value from Type III F-test|ANCOVA|Study center, treatment, visit and a treatment-by-visit interaction as fixed effects; prior anti-diabetic treatment and baseline FPG as covariates||Week 12: Difference in LS mean change in FPG from baseline to week 12 was obtained by comparing Bexagliflozin 20 mg group and Placebo group||-0.63|-1.52|< 0.0001
72479487|NCT02390050|144485072|SUPERIORITY||Difference of LS Means|-0.19|||||TWO_SIDED|95.0|-3.9|3.51||||||Week 2: Difference in LS mean change in SBP from baseline to week 2 was obtained by comparing Bexagliflozin 5 mg group and Placebo group||3.51|-3.90|
72479488|NCT02390050|144485072|SUPERIORITY||Difference of LS Means|-2.41|||||TWO_SIDED|95.0|-6.09|1.28||||||Week 2: Difference in LS mean change in SBP from baseline to week 2 was obtained by comparing Bexagliflozin 10 mg group and Placebo group||1.28|-6.09|
72479489|NCT02390050|144485072|SUPERIORITY||Difference of LS Means|-4.25|||||TWO_SIDED|95.0|-7.93|-0.58||||||Week 2: Difference in LS mean change in SBP from baseline to week 2 was obtained by comparing Bexagliflozin 20 mg group and Placebo group||-0.58|-7.93|
72479490|NCT02390050|144485072|SUPERIORITY||Difference of LS Means|-0.18|||||TWO_SIDED|95.0|-2.5|2.13||||||Week 2: Difference in LS mean change in DBP from baseline to week 2 was obtained by comparing Bexagliflozin 5 mg group and Placebo group||2.13|-2.50|
72479491|NCT02390050|144485072|SUPERIORITY||Difference of LS Means|-1.74|||||TWO_SIDED|95.0|-4.03|0.56||||||Week 2: Difference in LS mean change in DBP from baseline to week 2 was obtained by comparing Bexagliflozin 10 mg group and Placebo group||0.56|-4.03|
72479492|NCT02390050|144485072|SUPERIORITY||Difference of LS Means|-2.15|||||TWO_SIDED|95.0|-4.45|0.14||||||Week 2: Difference in LS mean change in DBP from baseline to week 2 was obtained by comparing Bexagliflozin 20 mg group and Placebo group||0.14|-4.45|
72479493|NCT02390050|144485072|SUPERIORITY||Difference of LS Means|-0.84|||||TWO_SIDED|95.0|-4.57|2.9||||||Week 6: Difference in LS mean change in SBP from baseline to week 6 was obtained by comparing Bexagliflozin 5 mg group and Placebo group||2.90|-4.57|
72479494|NCT02390050|144485072|SUPERIORITY||Difference of LS Means|-3.39|||||TWO_SIDED|95.0|-7.12|0.34||||||Week 6: Difference in LS mean change in SBP from baseline to week 6 was obtained by comparing Bexagliflozin 10 mg group and Placebo group||0.34|-7.12|
72479495|NCT02390050|144485072|SUPERIORITY||Difference of LS Means|-2.51|||||TWO_SIDED|95.0|-6.21|1.2||||||Week 6: Difference in LS mean change in SBP from baseline to week 6 was obtained by comparing Bexagliflozin 20 mg group and Placebo group||1.20|-6.21|
72479496|NCT02390050|144485072|SUPERIORITY||Difference of LS Means|0.25|||||TWO_SIDED|95.0|-2.15|2.66||||||Week 6: Difference in LS mean change in DBP from baseline to week 6 was obtained by comparing Bexagliflozin 5 mg group and Placebo group||2.66|-2.15|
72479497|NCT02390050|144485072|SUPERIORITY||Difference of LS Means|-1.02|||||TWO_SIDED|95.0|-3.42|1.38||||||Week 6: Difference in LS mean change in DBP from baseline to week 6 was obtained by comparing Bexagliflozin 10 mg group and Placebo group||1.38|-3.42|
72479498|NCT02390050|144485072|SUPERIORITY||Difference of LS Means|-0.84|||||TWO_SIDED|95.0|-3.22|1.54||||||Week 6: Difference in LS mean change in DBP from baseline to week 6 was obtained by comparing Bexagliflozin 20 mg group and Placebo group||1.54|-3.22|
72479499|NCT02390050|144485072|SUPERIORITY||Difference of LS Means|-2.16||||0.3001|TWO_SIDED|95.0|-6.26|1.94||P-value from Type III F-test|ANCOVA|Study center, treatment, visit and a treatment-by-visit interaction as fixed effects; prior anti-diabetic treatment and baseline SBP as covariates||Week 12: Difference in LS mean change in SBP from baseline to week 12 was obtained by comparing Bexagliflozin 5 mg group and Placebo group||1.94|-6.26|0.3001
72479500|NCT02390050|144485072|SUPERIORITY||Difference of LS Means|-4.41||||0.0343|TWO_SIDED|95.0|-8.49|-0.33||P-value from Type III F-test|ANCOVA|Study center, treatment, visit and a treatment-by-visit interaction as fixed effects; prior anti-diabetic treatment and baseline SBP as covariates||Week 12: Difference in LS mean change in SBP from baseline to week 12 was obtained by comparing Bexagliflozin 10 mg group and Placebo group||-0.33|-8.49|0.0343
72479501|NCT02390050|144485072|SUPERIORITY||Difference of LS Means|-3.83||||0.0679|TWO_SIDED|95.0|-7.95|0.28|||ANCOVA|Study center, treatment, visit and a treatment-by-visit interaction as fixed effects; prior anti-diabetic treatment and baseline SBP as covariates||Week 12: Difference in LS mean change in SBP from baseline to week 12 was obtained by comparing Bexagliflozin 20 mg group and Placebo group||0.28|-7.95|0.0679
72479502|NCT02390050|144485072|SUPERIORITY||Difference of LS Means|-2.24||||0.0776|TWO_SIDED|95.0|-4.73|0.25||P-value from Type III F-test|ANCOVA|Study center, treatment, visit and a treatment-by-visit interaction as fixed effects; prior anti-diabetic treatment and baseline SBP as covariates||Week 12: Difference in LS mean change in DBP from baseline to week 12 was obtained by comparing Bexagliflozin 5 mg group and Placebo group||0.25|-4.73|0.0776
72479503|NCT02390050|144485072|SUPERIORITY||Difference of LS Means|-1.47||||0.2415|TWO_SIDED|95.0|-3.95|1.0||P-value from Type III F-test|ANCOVA|Study center, treatment, visit and a treatment-by-visit interaction as fixed effects; prior anti-diabetic treatment and baseline SBP as covariates||Week 12: Difference in LS mean change in DBP from baseline to week 12 was obtained by comparing Bexagliflozin 10 mg group and Placebo group||1.00|-3.95|0.2415
72479504|NCT02390050|144485072|SUPERIORITY||Difference of LS Means|-2.04||||0.1086|TWO_SIDED|95.0|-4.54|0.46||P-value from Type III F-test|ANCOVA|Study center, treatment, visit and a treatment-by-visit interaction as fixed effects; prior anti-diabetic treatment and baseline SBP as covariates||Week 12: Difference in LS mean change in DBP from baseline to week 12 was obtained by comparing Bexagliflozin 20 mg group and Placebo group||0.46|-4.54|0.1086
72479505|NCT02390050|144485073|SUPERIORITY||Difference of LS Means|-0.09|||||TWO_SIDED|95.0|-0.2|0.03||||||Week 2: Difference in LS Mean change in HbA1c (%) from baseline to Week 2 was obtained by comparing Bexagliflozin 5 mg group and Placebo group||0.03|-0.20|
72479506|NCT02390050|144485073|SUPERIORITY||Difference of LS Means|-0.13|||||TWO_SIDED|95.0|-0.24|-0.02||||||Week 2: Difference in LS Mean change in HbA1c (%) from baseline to Week 2 was obtained by comparing Bexagliflozin 10 mg group and Placebo group||-0.02|-0.24|
72623646|NCT00600340|144778108|SUPERIORITY||Odds Ratio (OR)|0.42|||<|0.0001|TWO_SIDED|95.0|0.29|0.6||"Test adjusted by stratification factors at randomization:~1. estrogen and/or progesterone status (positive vs. other)~2. country~3. menopausal status (premenopausal or male \<=50 years of age vs. postmenopausal or male \>50 years of age"|Cochran-Mantel-Haenszel||OR is the odds for objective response of Bevacizumab Plus Capecitabine divided by the odds for objective response of Bevacizumab plus Paclitaxel|OR of objective response and CMH test (stratified)||0.60|0.29|< 0.0001
72400253|NCT01327300|144308320|SUPERIORITY_OR_OTHER|||||||0.873|||||||Wilcoxon (Mann-Whitney)|||Correlation coefficients were used for each of three biomarkers in relation to other biomarkers and to the questionnaires and patient's symptoms.||||0.873
72479507|NCT02390050|144485073|SUPERIORITY||Difference of LS Means|-0.13|||||TWO_SIDED|95.0|-0.24|-0.02||||||Week 2: Difference in LS Mean change in HbA1c (%) from baseline to Week 2 was obtained by comparing Bexagliflozin 20 mg group and Placebo group||-0.02|-0.24|
72479508|NCT02390050|144485073|SUPERIORITY||Difference of LS Means|-0.45|||||TWO_SIDED|95.0|-0.62|-0.28||||||Week 6: Difference in LS Mean change in HbA1c (%) from baseline to Week 6 was obtained by comparing Bexagliflozin 5 mg group and Placebo group||-0.28|-0.62|
72623647|NCT00600340|144778108|SUPERIORITY||Risk Difference (RD)|-21.0|||||TWO_SIDED|95.0|-30.0|-13.0|||||Difference calculated as ORR in Bevacizumab Plus Capecitabine minus ORR in Bevacizumab plus Paclitaxel, unit in percent.|Difference in ORR in Bevacizumab Plus Capecitabine vs. Bevacizumab plus Paclitaxel||-13|-30|
72479509|NCT02390050|144485073|SUPERIORITY||Difference of LS Means|-0.49|||||TWO_SIDED|95.0|-0.66|-0.32||||||Week 6: Difference in LS Mean change in HbA1c (%) from baseline to Week 6 was obtained by comparing Bexagliflozin 10 mg group and Placebo group||-0.32|-0.66|
72479510|NCT02390050|144485073|SUPERIORITY||Difference of LS Means|-0.53|||||TWO_SIDED|95.0|-0.7|-0.36||||||Week 6: Difference in LS Mean change in HbA1c (%) from baseline to Week 6 was obtained by comparing Bexagliflozin 20 mg group and Placebo group||-0.36|-0.70|
72479511|NCT02390050|144485073|SUPERIORITY||Difference of LS Means|-0.55|||<|0.0001|TWO_SIDED|95.0|-0.76|-0.34||P-value from Type III F-test|ANCOVA|Study center, treatment, visit and a treatment-by-visit interaction as fixed effects; prior anti-diabetic treatment and baseline HbA1c as covariates||Week 12: Difference in LS Mean change in HbA1c (%) from baseline to Week 12 was obtained by comparing Bexagliflozin 5 mg group and Placebo group||-0.34|-0.76|< 0.0001
72509431|NCT00783705|144549666|SUPERIORITY_OR_OTHER|||||||0.91|TWO_SIDED||||||Wilcoxon Rank-Sum|||Comparison of the median difference in biomarker Nitrotyrosine level between arms.||||0.91
72400254|NCT01327300|144308320|SUPERIORITY_OR_OTHER|||||||0.81|||||||Wilcoxon (Mann-Whitney)|Pearson's linear coefficient||The study tested three biomarkers and symptom domains at baseline and the end of 12 weeks of placebo using the Mann-Whitney test, as well as correlations between domains with Pearson's linear correlation coefficient.||||0.810
72479512|NCT02390050|144485073|SUPERIORITY||Difference of LS Means|-0.68|||<|0.0001|TWO_SIDED|95.0|-0.89|-0.47||P-value from Type III F-test|ANCOVA|Study center, treatment, visit and a treatment-by-visit interaction as fixed effects; prior anti-diabetic treatment and baseline HbA1c as covariates||Week 12: Difference in LS Mean change in HbA1c (%) from baseline to Week 12 was obtained by comparing Bexagliflozin 10 mg group and Placebo group||-0.47|-0.89|< 0.0001
72479513|NCT02390050|144485073|SUPERIORITY||Difference of LS Means|-0.8|||<|0.0001|TWO_SIDED|95.0|-1.01|-0.59||P-value from Type III F-test|ANCOVA|Study center, treatment, visit and a treatment-by-visit interaction as fixed effects; prior anti-diabetic treatment and baseline HbA1c as covariates||Week 12: Difference in LS Mean change in HbA1c (%) from baseline to Week 12 was obtained by comparing Bexagliflozin 20 mg group and Placebo group||-0.59|-1.01|< 0.0001
72479514|NCT01775124|144485074|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.6|||||TWO_SIDED|95.0|-2.95|-0.2|||ANOVA|||Descriptive, no hypothesis||-0.2|-2.95|
72479515|NCT00346268|144485086|SUPERIORITY_OR_OTHER||least square (LS) mean difference (net)|-7.58|STANDARD_ERROR_OF_MEAN|3.55||0.035|TWO_SIDED|95.0|-14.63|-0.53||Adjusted for treatment group and center|ANOVA|||||-0.53|-14.63|0.035
72479516|NCT00346268|144485087|SUPERIORITY_OR_OTHER||least square (LS) mean difference (net)|-15.16|STANDARD_ERROR_OF_MEAN|5.2||0.004|TWO_SIDED|95.0|-25.47|-4.85||Adjusted for treatment group and center|ANOVA|||||-4.85|-25.47|0.004
72479517|NCT00346268|144485088|SUPERIORITY_OR_OTHER|||||||0.257||95.0|||||Log Rank|Stratified by center||||||0.257
72479518|NCT00346268|144485089|SUPERIORITY_OR_OTHER||LS mean difference (net)|-0.07|STANDARD_ERROR_OF_MEAN|0.3||0.81|TWO_SIDED|95.0|-0.68|0.53||Adjusted for treatment group and center|ANCOVA|Covariates:Total RBCUs and RBCUs substituted during surgery, baseline hemoglobin, swab and lavage weights, intraoperative blood loss fluid volume||||0.53|-0.68|0.810
72479519|NCT00346268|144485091|SUPERIORITY_OR_OTHER||Least squares mean difference (net)|0.17|STANDARD_ERROR_OF_MEAN|0.09||0.07|TWO_SIDED|95.0|-0.01|0.35|||ANOVA|||The difference in pain at rest prior to administration and pain at rest post administration compared between treatments at 48 hours post surgery.||0.35|-0.01|0.070
72479520|NCT00346268|144485091|SUPERIORITY_OR_OTHER||LS Mean Difference (net)|0.16|STANDARD_ERROR_OF_MEAN|0.09||0.074|TWO_SIDED|95.0|-0.02|0.33|||ANOVA|||The difference in pain at movement prior to administration and pain at movement post administration compared between treatments at 48 hours post surgery.||0.33|-0.02|0.074
72479521|NCT00346268|144485092|SUPERIORITY_OR_OTHER||LS mean difference (net)|-0.71|STANDARD_ERROR_OF_MEAN|0.23||0.002|TWO_SIDED|95.0|-1.16|-0.26||Adjusted for treatment group and center|ANOVA|||24 hours post surgery||-0.26|-1.16|0.002
72479522|NCT00346268|144485092|SUPERIORITY_OR_OTHER||LS mean difference (net)|-0.73|STANDARD_ERROR_OF_MEAN|0.25||0.004|TWO_SIDED|95.0|-1.22|-0.23||Adjusted for treatment group and center|ANOVA|||48 hours post surgery||-0.23|-1.22|0.004
72479523|NCT00346268|144485093|SUPERIORITY_OR_OTHER||LS mean difference (net)|-1.16|STANDARD_ERROR_OF_MEAN|0.3||0.001|TWO_SIDED|95.0|-1.77|-0.56||Adjusted for treatment group and center|ANOVA|||24 hours post surgery||-0.56|-1.77|0.001
72566580|NCT02985879|144663396|SUPERIORITY|The analysis utilized a likelihood-based, mixed-effects model, repeated measures (MMRM) analysis of the change from baseline for each postbaseline value and compared each ABBV-8E12 dose group with the placebo group. The model, which used all observed data, included fixed, categorical effects for treatment, site, visit, baseline score-by-visit interaction and treatment-by-visit interaction, with continuous fixed covariates for the corresponding baseline score.|LS Mean Difference|4.0|STANDARD_ERROR_OF_MEAN|3.88|=|0.304|TWO_SIDED|95.0|-3.65|11.65|||Mixed-effects model, repeated measures||ABBV-8E12 2000 mg - Placebo|ABBV-8E12 2000 mg vs Placebo||11.65|-3.65|=0.304
72623648|NCT00600340|144778108|SUPERIORITY|OR is the odds for disease control of Bevacizumab Plus Capecitabine divided by the odds for disease control of Bevacizumab plus Paclitaxel|Odds Ratio (OR)|0.39||||0.0003|TWO_SIDED|95.0|0.24|0.65||"Test adjusted by stratification factors at randomization:~1. estrogen and/or progesterone status (positive vs. other)~2. country~3. menopausal status (premenopausal or male \<=50 years of age vs. postmenopausal or male \>50 years of age"|Cochran-Mantel-Haenszel||OR is the odds for disease control of Bevacizumab Plus Capecitabine divided by the odds for disease control of Bevacizumab plus Paclitaxel|OR of disease control and CMH test (stratified)||0.65|0.24|0.0003
72623649|NCT00600340|144778108|SUPERIORITY||Risk Difference (RD)|-12.0|||||TWO_SIDED|95.0|-19.0|-6.0|||||Difference calculated as DCR in Bevacizumab Plus Capecitabine minus DCR in Bevacizumab plus Paclitaxel, unit in percent.|Difference in DCR in Bevacizumab Plus Capecitabine vs. Bevacizumab plus Paclitaxel||-6|-19|
72400255|NCT01327300|144308321|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.5||||0.67|||||||t-test, 2 sided|Two-tailed P values are listed for baseline versus 12 weeks of mesalamine||"The FBDSI score is based on the severity of abdominal pian. Severity is rated as the following:~None= 0 points Mild= (1-36) Moderate =(37-110) Severe= (\>110 points)"||||0.67
72479524|NCT00346268|144485093|SUPERIORITY_OR_OTHER||LS mean difference (net)|-0.83|STANDARD_ERROR_OF_MEAN|0.3||0.006|TWO_SIDED|95.0|-1.41|-0.24||Adjusted for treatment group and center|ANOVA|||48 hours post surgery||-0.24|-1.41|0.006
72479525|NCT02502097|144485104|SUPERIORITY|MMRM model uses the change from baseline as the dependent variable and includes the period, treatment group (Gefapixant 50 mg, Placebo), visit (Day 7 and Day 14 at each Period), all interactions terms as fixed factors, and baseline as a covariate.|Mean Difference (Final Values)|-2.5||||0.5096|TWO_SIDED|95.0|-10.1|5.1|||Mixed Models Analysis||LS mean difference Day 7|||5.1|-10.1|0.5096
72479526|NCT02502097|144485104|SUPERIORITY|MMRM model uses the change from baseline as the dependent variable and includes the period, treatment group (Gefapixant 50 mg, Placebo), visit (Day 7 and Day 14 at each Period), all interactions terms as fixed factors, and baseline as a covariate.|Mean Difference (Final Values)|-0.8||||0.8983|TWO_SIDED|95.0|-13.4|11.8|||Mixed Models Analysis||LS mean difference Day 14|||11.8|-13.4|0.8983
72479527|NCT02502097|144485108|SUPERIORITY|MMRM model uses the change from baseline as the dependent variable and includes the period, treatment group (Gefapixant 50 mg, Placebo), visit (Day 7 and Day 14 at each Period), all interactions terms as fixed factors, and baseline as a covariate.|Mean Difference (Final Values)|-3.7||||0.5005|TWO_SIDED|95.0|-14.6|7.2|||Mixed Models Analysis||LS means difference Day 7|||7.2|-14.6|0.5005
72400256|NCT01327300|144308321|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|17.0||||0.77|||||||t-test, 2 sided|||See prior description of the FBDSI score. Change in the FBDSI after 12 weeks of intervention is made using a two sided t-test.||||0.77
72509432|NCT00783705|144549667|SUPERIORITY_OR_OTHER|||||||0.46|TWO_SIDED||||||Wilcoxon Rank-Sum|||Comparison of the median difference in biomarker CC18 level between arms.||||0.46
72400257|NCT01327300|144308322|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.0||||0.61|||||||t-test, 2 sided|||For the IBS QOL we compared the change in IBS-Quality of Life (IBS-QOL) after 12 weeks of mesalamine.||||0.61
72509433|NCT00783705|144549668|SUPERIORITY_OR_OTHER|||||||0.52|TWO_SIDED||||||Wilcoxon Rank-Sum|||Comparison of the median difference in biomarker SFTPD level between arms.||||0.52
72576855|NCT00261443|144680662|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.03||||0.875|TWO_SIDED|95.0|-0.34|0.29||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 44 Comparison||0.29|-0.34|0.875
72479528|NCT02502097|144485108|SUPERIORITY|MMRM model uses the change from baseline as the dependent variable and includes the period, treatment group (Gefapixant 50 mg, Placebo), visit (Day 7 and Day 14 at each Period), all interactions terms as fixed factors, and baseline as a covariate.|Mean Difference (Final Values)|-1.8||||0.8382|TWO_SIDED|95.0|-19.8|16.1|||Mixed Models Analysis||LS means difference Day 14|||16.1|-19.8|0.8382
72479529|NCT02502097|144485109|SUPERIORITY|MMRM model uses the change from baseline as the dependent variable and includes the period, treatment group (Gefapixant 50 mg, Placebo), visit (Day 7 and Day 14 at each Period), all interactions terms as fixed factors, and baseline as a covariate.|Mean Difference (Final Values)|-1.3||||0.8008|TWO_SIDED|95.0|-11.9|9.2|||Mixed Models Analysis||LS means difference Day 7|||9.2|-11.9|0.8008
72479530|NCT02502097|144485109|SUPERIORITY|MMRM model uses the change from baseline as the dependent variable and includes the period, treatment group (Gefapixant 50 mg, Placebo), visit (Day 7 and Day 14 at each Period), all interactions terms as fixed factors, and baseline as a covariate.|Mean Difference (Final Values)|0.2||||0.9805|TWO_SIDED|95.0|-17.6|18.0|||Mixed Models Analysis||LS means difference Day 14|||18.0|-17.6|0.9805
72479531|NCT02502097|144485112|SUPERIORITY|MMRM model uses the change from baseline as the dependent variable and includes the period, treatment group (Gefapixant 50 mg, Placebo), visit (Day 7 and Day 14 at each Period), all interactions terms as fixed factors, and baseline as a covariate.|Mean Difference (Final Values)|-2.4||||0.3279|TWO_SIDED|95.0|-7.1|2.4|||Mixed Models Analysis||LS means difference Day 7|||2.4|-7.1|0.3279
72479532|NCT02502097|144485112|SUPERIORITY|MMRM model uses the change from baseline as the dependent variable and includes the period, treatment group (Gefapixant 50 mg, Placebo), visit (Day 7 and Day 14 at each Period), all interactions terms as fixed factors, and baseline as a covariate.|Mean Difference (Final Values)|1.5||||0.7772|TWO_SIDED|95.0|-9.2|12.3|||Mixed Models Analysis||LS means difference Day 14|||12.3|-9.2|0.7772
72479533|NCT02502097|144485113|SUPERIORITY|MMRM model uses the change from baseline as the dependent variable and includes the period, treatment group (Gefapixant 50 mg, Placebo), visit (Day 7 and Day 14 at each Period), all interactions terms as fixed factors, and baseline as a covariate.|Mean Difference (Final Values)|-3.2||||0.3493|TWO_SIDED|95.0|-10.1|3.6|||Mixed Models Analysis||LS means difference Day 7|||3.6|-10.1|0.3493
72479534|NCT02502097|144485113|SUPERIORITY|MMRM model uses the change from baseline as the dependent variable and includes the period, treatment group (Gefapixant 50 mg, Placebo), visit (Day 7 and Day 14 at each Period), all interactions terms as fixed factors, and baseline as a covariate.|Mean Difference (Final Values)|1.0||||0.8952|TWO_SIDED|95.0|-14.3|16.3|||Mixed Models Analysis||LS means difference Day 14|||16.3|-14.3|0.8952
72479535|NCT02502097|144485114|SUPERIORITY|MMRM model uses the change from baseline as the dependent variable and includes the period, treatment group (Gefapixant 50 mg, Placebo), visit (Day 7 and Day 14 at each Period), all interactions terms as fixed factors, and baseline as a covariate.|Mean Difference (Final Values)|-1.5||||0.6597|TWO_SIDED|95.0|-8.1|5.2|||Mixed Models Analysis||LS means difference Day 7|||5.2|-8.1|0.6597
72479536|NCT02502097|144485114|SUPERIORITY|MMRM model uses the change from baseline as the dependent variable and includes the period, treatment group (Gefapixant 50 mg, Placebo), visit (Day 7 and Day 14 at each Period), all interactions terms as fixed factors, and baseline as a covariate.|Mean Difference (Final Values)|2.1||||0.788|TWO_SIDED|95.0|-13.1|17.2|||Mixed Models Analysis||LS means difference Day 14|||17.2|-13.1|0.7880
72479537|NCT02502097|144485118|SUPERIORITY|MMRM model uses the change from baseline as the dependent variable and includes the period, treatment group (Gefapixant 50 mg, Placebo), visit (Day 7 and Day 14 at each Period), all interactions terms as fixed factors, and baseline as a covariate.|Mean Difference (Final Values)|-2.5||||0.1856|TWO_SIDED|95.0|-6.3|1.3|||Mixed Models Analysis||LS mean difference Day 7|||1.3|-6.3|0.1856
72479538|NCT02502097|144485118|SUPERIORITY|MMRM model uses the change from baseline as the dependent variable and includes the period, treatment group (Gefapixant 50 mg, Placebo), visit (Day 7 and Day 14 at each Period), all interactions terms as fixed factors, and baseline as a covariate.|Mean Difference (Final Values)|2.7||||0.5658|TWO_SIDED|95.0|-6.6|12.1|||Mixed Models Analysis||LS mean difference Day 14|||12.1|-6.6|0.5658
72479539|NCT02502097|144485119|SUPERIORITY|MMRM model uses the change from baseline as the dependent variable and includes the period, treatment group (Gefapixant 50 mg, Placebo), visit (Day 7 and Day 14 at each Period), all interactions terms as fixed factors, and baseline as a covariate.|Mean Difference (Final Values)|-8.0||||0.0847|TWO_SIDED|95.0|-17.2|1.1|||Mixed Models Analysis||LS mean difference Day 7|||1.1|-17.2|0.0847
72479540|NCT02502097|144485119|SUPERIORITY|MMRM model uses the change from baseline as the dependent variable and includes the period, treatment group (Gefapixant 50 mg, Placebo), visit (Day 7 and Day 14 at each Period), all interactions terms as fixed factors, and baseline as a covariate.|Mean Difference (Final Values)|-5.8||||0.3083|TWO_SIDED|95.0|-17.0|5.4|||Mixed Models Analysis||LS mean difference Day 14|||5.4|-17.0|0.3083
72479541|NCT02502097|144485120|SUPERIORITY|MMRM model uses the change from baseline as the dependent variable and includes the period, treatment group (Gefapixant 50 mg, Placebo), visit (Day 7 and Day 14 at each Period), all interactions terms as fixed factors, and baseline as a covariate.|Mean Difference (Final Values)|-2.0||||0.229|TWO_SIDED|95.0|-5.3|1.3|||Mixed Models Analysis||LS mean difference Day 7|||1.3|-5.3|0.2290
72400258|NCT01327300|144308322|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.2||||0.33|||||||t-test, 2 sided|||Comparison of change in IBS-Quality of Life (IBS-QOL)from baseline after 12 weeks of intervention was made.||||0.33
72479542|NCT02502097|144485120|SUPERIORITY|MMRM model uses the change from baseline as the dependent variable and includes the period, treatment group (Gefapixant 50 mg, Placebo), visit (Day 7 and Day 14 at each Period), all interactions terms as fixed factors, and baseline as a covariate.|Mean Difference (Final Values)|0.0||||0.9794|TWO_SIDED|95.0|-3.5|3.4|||Mixed Models Analysis||LS mean difference Day 14|||3.4|-3.5|0.9794
72479543|NCT02502097|144485121|SUPERIORITY|MMRM model uses the change from baseline as the dependent variable and includes the period, treatment group (Gefapixant 50 mg, Placebo), visit (Day 7 and Day 14 at each Period), all interactions terms as fixed factors, and baseline as a covariate.|Mean Difference (Final Values)|-1.0||||0.0009|TWO_SIDED|95.0|-1.5|-0.4|||Mixed Models Analysis||LS mean difference Week 1|||-0.4|-1.5|0.0009
72479544|NCT02502097|144485121|SUPERIORITY|MMRM model uses the change from baseline as the dependent variable and includes the period, treatment group (Gefapixant 50 mg, Placebo), visit (Day 7 and Day 14 at each Period), all interactions terms as fixed factors, and baseline as a covariate.|Mean Difference (Final Values)|-1.0||||0.005|TWO_SIDED|95.0|-1.7|-0.3|||Mixed Models Analysis||LS mean difference Week 2|||-0.3|-1.7|0.0050
72479545|NCT02502097|144485122|SUPERIORITY|MMRM model uses the change from baseline as the dependent variable and includes the period, treatment group (Gefapixant 50 mg, Placebo), visit (Day 7 and Day 14 at each Period), all interactions terms as fixed factors, and baseline as a covariate.|Mean Difference (Final Values)|-2.8||||0.2938|TWO_SIDED|95.0|-8.2|2.5|||Mixed Models Analysis||LS mean difference Day 7|||2.5|-8.2|0.2938
72479546|NCT02502097|144485122|SUPERIORITY|MMRM model uses the change from baseline as the dependent variable and includes the period, treatment group (Gefapixant 50 mg, Placebo), visit (Day 7 and Day 14 at each Period), all interactions terms as fixed factors, and baseline as a covariate.|Mean Difference (Final Values)|-4.0||||0.1319|TWO_SIDED|95.0|-9.2|1.2|||Mixed Models Analysis||LS mean difference Day 14|||1.2|-9.2|0.1319
72479547|NCT02502097|144485123|SUPERIORITY||Mean Difference (Final Values)|-0.6||||0.2175|TWO_SIDED|95.0|-1.5|0.4|||Mixed Models Analysis||LS mean difference Day 7|||0.4|-1.5|0.2175
72479548|NCT02502097|144485123|SUPERIORITY||Mean Difference (Final Values)|-0.3||||0.5312|TWO_SIDED|95.0|-1.4|0.7|||Mixed Models Analysis||LS mean difference Day 14|||0.7|-1.4|0.5312
72479549|NCT00252733|144485151|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.821||||0.0508|TWO_SIDED|95.0|0.673|1.001|||Log Rank|Generalized||||1.001|0.673|0.0508
72509434|NCT01954121|144549669|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin for the adjusted difference in seizure free proportion in the LEV minus the seizure free proportion in the CBZ-IR group was set to absolute -20% points.|adjusted difference in proportions|-22.9|||||TWO_SIDED|95.0|-33.1|-12.6||||||The adjusted absolute difference in treatment group seizure-free proportions (referenced as 'Adjusted difference in proportions' in 'Method of Estimation' below) was derived from the adjusted treatment group proportions of seizure-free subjects. The adjusted proportions were derived from a logistic regression model of seizure freedom using treatment and the categories for the number of seizures in the 3-month period prior to Visit 1 (≤2 seizures and \>2 seizures) as covariates.||-12.6|-33.1|
72509435|NCT00576693|144549702|SUPERIORITY_OR_OTHER|||||||0.0252|||||||Log Rank|||The statistical analysis was based on a comparison of the of the two treatment groups with respect to the time to a primary outcome using the logrank test.||||0.0252
72400259|NCT01327300|144308323|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.3||||0.71||95.0|||||t-test, 2 sided|||Comparison of the change in HADS score of baseline to 12 weeks of mesalamine is made.||||0.71
72400260|NCT01327300|144308323|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.4||||0.57||95.0|||||t-test, 2 sided|||Comparison of change in HADS score between baseline and after 12 weeks of placebo is made.||||0.57
72400261|NCT01327300|144308324|SUPERIORITY_OR_OTHER|||||||0.55||95.0|||||t-test, 2 sided|||Comparison of the lactulose/mannitol ratio is made after a 12 week intervention with mesalamine to 12 weeks of placebo.||||0.55
72400262|NCT02807350|144308333|OTHER||Risk Difference (RD)|19.0|||||TWO_SIDED|95.0|7.0|29.0||||||\>1 point analysis||29|7|
72400263|NCT02807350|144308333|OTHER|\>2 points analysis|Risk Difference (RD)|20.0|||||TWO_SIDED|95.0|10.0|28.0||||||||28|10|
72400264|NCT02807350|144308334|OTHER|\>1 analysis|Risk Difference (RD)|4.0|||||TWO_SIDED|95.0|-7.0|15.0||||||||15|-7|
72400265|NCT02807350|144308334|OTHER|\>2 analysis|Risk Difference (RD)|8.0|||||TWO_SIDED|95.0|-2.0|17.0||||||||17|-2|
72400266|NCT03739112|144308352|NON_INFERIORITY|Non-inferiority was concluded if the lower limit of the two-sided 95% confidence interval (CI) for relative vaccine efficacy (VE) was \> -20%.|percent VE|8.8|||||TWO_SIDED|95.0|-16.7|28.7|||||VE of VLP vaccine versus Fluarix = (1-ARVv/ARVc) x 100% where ARVv = attack rate in participants vaccinated with the Quadrivalent VLP Influenza vaccine and ARVc = attack rate in participants vaccinated with an active Fluarix.|||28.7|-16.7|
72479550|NCT00706433|144485173|SUPERIORITY_OR_OTHER|||||||0.768||95.0|||||ANCOVA|Rank ANCOVA with baseline total inflammatory lesion counts serving as the covariate.||Null hypothesis: equal median changes from baseline in total inflammatory lesion counts among the treatments||||0.7680
72479551|NCT00706433|144485174|SUPERIORITY_OR_OTHER|||||||0.7975||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Null hypothesis: equal success rates.||||0.7975
72479552|NCT00706433|144485175|SUPERIORITY_OR_OTHER||||||>|0.1||95.0|||||ANOVA|Rank transformed data.||Null hypothesis: equal median percent changes from baseline in total inflammatory lesion counts among the treatments||||>0.10
72479553|NCT00706433|144485176|SUPERIORITY_OR_OTHER||||||>|0.1||95.0|||||ANOVA|Rank transformed data.||Null hypothesis: equal median percent changes from baseline in total inflammatory lesion counts among the treatments||||>0.10
72479554|NCT00706433|144485178|SUPERIORITY_OR_OTHER|||||||0.1103||95.0|||||ANCOVA|Rank ANCOVA with baseline total inflammatory lesion counts serving as the covariate.||Null hypothesis: equal median changes from baseline in total inflammatory lesion counts among the treatments||||0.1103
72479555|NCT00706433|144485179|SUPERIORITY_OR_OTHER|||||||0.7228||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Null hypothesis: equal success rates.||||0.7228
72576856|NCT00261443|144680662|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.14||||0.378|TWO_SIDED|95.0|-0.46|0.17||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 48 Comparison||0.17|-0.46|0.378
72479556|NCT00706433|144485180|SUPERIORITY_OR_OTHER|||||||0.3416||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates||||0.3416
72479557|NCT00706433|144485181|SUPERIORITY_OR_OTHER|||||||0.5759||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.5759
72479558|NCT00706433|144485182|SUPERIORITY_OR_OTHER|||||||0.4754||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.4754
72479559|NCT00706433|144485183|SUPERIORITY_OR_OTHER|||||||0.4096||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.4096
72479560|NCT00706433|144485184|SUPERIORITY_OR_OTHER|||||||0.5812||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.5812
72479561|NCT00706433|144485185|SUPERIORITY_OR_OTHER|||||||0.8679||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.8679
72479562|NCT00706433|144485186|SUPERIORITY_OR_OTHER|||||||0.3666||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.3666
72479563|NCT00706433|144485187|SUPERIORITY_OR_OTHER|||||||0.308||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.3080
72479564|NCT00706433|144485188|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||1.0
72479565|NCT00706433|144485189|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||1.0
72479566|NCT00706433|144485190|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||1.0
72400267|NCT00587483|144308407|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.81||||0.427|TWO_SIDED|95.0|0.48|1.37||An alpha of 0.0167 was used to account for multiple comparisons among the 3 groups. Given the total of 3 comparisons, 0.05/3 = 0.0167 was used in the calculation.|Regression, Logistic|||The expected overall incidence of ventricular fibrillation after removal of the aortic clamp is at least 70%. Using a chi square analysis with 80% power and an alpha of 0.0167, we estimate that we will need 113 patients in each group to show a 30% reduction in the incidence of ventricular fibrillation with amiodarone.||1.37|0.48|0.427
72400268|NCT00587483|144308407|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.65||||0.117|TWO_SIDED|95.0|0.39|1.11|||Regression, Logistic|||||1.11|0.39|0.117
72400269|NCT00587483|144308407|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.8||||0.433|TWO_SIDED|95.0|0.47|1.37|||Regression, Logistic|||||1.37|0.47|0.433
72400270|NCT00587483|144308408|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.74||||0.215|TWO_SIDED|95.0|0.45|1.19|||Regression, Logistic|||||1.19|0.45|0.215
72400271|NCT00587483|144308408|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.51||||0.008|TWO_SIDED|95.0|0.32|0.84|||Regression, Logistic|||||0.84|0.32|0.008
72400272|NCT00587483|144308408|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.82||||0.424|TWO_SIDED|95.0|0.52|1.33|||Regression, Logistic|||||1.33|0.52|0.424
72400273|NCT02063516|144308414|SUPERIORITY_OR_OTHER|||||||0.04|TWO_SIDED|95.0|||||t-test, 2 sided|||It was calculated that 80 adult patients randomized from different surgical department would have 80% power to detect a difference in 2 point in mean. Sampling size was determined using 2 sided t-test (alpha=0.05).||||0.04
72400274|NCT02063516|144308415|SUPERIORITY_OR_OTHER|||||||0.836|TWO_SIDED|95.0|||||Chi-squared|||||||0.836
72400275|NCT02063516|144308416|SUPERIORITY_OR_OTHER|||||||0.0035|TWO_SIDED||||||t-test, 2 sided|||Amount of air added at 30 minutes to maintain cuff pressure 60cmH2O||||0.0035
72400276|NCT02063516|144308416|SUPERIORITY_OR_OTHER|||||||0.003|TWO_SIDED||||||t-test, 2 sided|||Amount of air added at 60 minutes to maintain cuff pressure 60cmH2O||||0.003
72400277|NCT02063516|144308416|SUPERIORITY_OR_OTHER|||||||0.0042|TWO_SIDED||||||t-test, 2 sided|||Amount of air added at 90 minutes to maintain cuff pressure 60cmH2O||||0.0042
72400278|NCT02063516|144308416|SUPERIORITY_OR_OTHER|||||||0.004|TWO_SIDED||||||t-test, 2 sided|||Amount of air added at 120 minutes to maintain cuff pressure 60cmH2O||||0.004
72400279|NCT02063854|144308417|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was tested using t-test at a one-sided significance level of 2.5% and a non-inferiority margin (Δ) of 1.5%.||||||0.1346|||||||t-test, 1 sided|With a non-inferiority margin (Δ) of 1.5%.||||||0.1346
72400280|NCT02063854|144308417|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was tested using t-test at a one-sided significance level of 2.5% and a non-inferiority margin (Δ) of 1.5%.||||||0.6711|||||||t-test, 1 sided|With a non-inferiority margin (Δ) of 1.5%.||||||0.6711
72400281|NCT02063854|144308417|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.96|||||TWO_SIDED|95.0|-1.92|0.001||||||||0.001|-1.920|
72400282|NCT02063854|144308417|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.71|||||TWO_SIDED|95.0|-2.617|-0.794||||||||-0.794|-2.617|
72400283|NCT02063854|144308417|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.75|||||TWO_SIDED|95.0|-0.166|1.658||||||||1.658|-0.166|
72400284|NCT03538158|144308430|SUPERIORITY||Slope|5.7||||0.82|TWO_SIDED|95.0|-287.7|299.1|||Mixed Models Analysis|F(2,131)=.07||||299.1|-287.7|.82
72400285|NCT03538158|144308431|SUPERIORITY||Slope|0.5||||0.97|TWO_SIDED|95.0|-3.5|4.4|||Mixed Models Analysis|F(2,75)=.03||||4.4|-3.5|.97
72400286|NCT02255981|144308447|OTHER|Non-inferiority could be considered if the outcomes were comparable to the most known studies yet published or, in the case of non-treatable disorder, if the acupuncture treatment got to maintain the VA and prevent the losses. There are many known studies with conventional treatment and estimations of the worsening of vision in this pathologies on the time without treatment.|Mean Difference (Final Values)|15.392|||<|0.05|TWO_SIDED|95.0||||"Using the SPSS program and the non-parametrical technic of Wilcoxon it was determined the p-value.~It should be noted that the null hypothesis is that all these eyes should have a zero gain or perhaps a loss in VA at two years of follow-up."|t-test, 1 sided|From this estimation, it is induced that there are differences in results before and after the treatment.|The datum corresponds to the difference in letters seen between exams at the start and the final examination for all participants. Calculi were made by a Microsoft Excel Descriptive Statistics program.|"Besides that it is of interest to compare with the published studies outcomes, realized with anti-VEGF treatments, and with the known expectations of AV lost without treatment, the data were converted in letters ETDRS chart and here are registered the mean number of letters gained or lost in each group.~Ho: Differences between mean measurements before and after are similar H1: Differences between mean measurements before and after are different."|The null hypothesis was no gain or loss in VA. The alternative hypothesis was stabilization or some gain in letters seen over the baseline count.The published studies report a small gain in VA in about a third of participants and only in cases of NV-AMD with conventional treatment, and an expectancy of loss of vision in the other non treated or non-treatable macular diseases. Some of the participants in this trial had had ocular injections without positive change. Non-inferiority in this trial means outcomes of similar magnitude to the known studies.|||<0.05
72400287|NCT02246673|144308475|SUPERIORITY_OR_OTHER||Geometric Least Squares mean Ratio|-28.18|||<|0.0001|TWO_SIDED|95.0|-33.85|-22.51|||Mixed Models Analysis|The model included treatment and period as fixed effects and subject(s) as a random effect.||Cohort 1||-22.51|-33.85|<0.0001
72400288|NCT02246673|144308475|SUPERIORITY_OR_OTHER||Geometric Least Squares mean Ratio|-25.29|||<|0.0001|TWO_SIDED|95.0|-31.23|-19.34|||Mixed Models Analysis|The model included treatment and period as fixed effects and subject(s) as a random effect.||Cohort 1||-19.34|-31.23|<0.0001
72509436|NCT00804193|144549708|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|90% CI was constructed for the difference in the Therapeutic Success rates between the Test Product and Reference Product at Visit 4/Week 6 (Follow-Up). The interval was calculated using Wald's method with Yates' continuity correction. Therapeutic equivalence (bioequivalence) was established if this 90% CI was contained within the interval -0.20 to +0.20 (-20% to +20%).|Difference in Percentage of Participants|9.0|||||TWO_SIDED|90.0|-0.69|18.85|||Wald's method, Yates|CI calculated using Wald's method with Yates' continuity correction.|The sample size for this study was calculated assuming that both active treatments would have equivalent success proportions of at least 55% and the Vehicle would have a success proportion no greater than 25%.|||18.85|-0.69|
72509437|NCT00804193|144549709|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|90% CI was constructed for the difference in the Success rates between the Test Product and Reference Product at Visit 4/Week 6 (Follow-Up). The interval was calculated using Wald's method with Yates' continuity correction. Bioequivalence was established if this 90% confidence interval was contained within the interval -0.20 to +0.20).|Difference in Percentage of Participants|1.0||||0.001|TWO_SIDED|90.0|-7.08|9.24|||Wald's method with Yates' continuity cor||The sample size for this study was calculated assuming that both active treatments would have equivalent success proportions of at least 55% and the Vehicle would have a success proportion no greater than 25%.|||9.24|-7.08|0.001
72509438|NCT00804193|144549710|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|90% CI was constructed for the difference in the Success rates between the Test Product and Reference Product at Visit 4/Week 6 (Follow-Up). The interval was calculated using Wald's method with Yates' continuity correction. Bioequivalence was established if this 90% confidence interval was contained within the interval -0.20 to +0.20).|Difference in Percentage of Participants|4.0||||0.001|TWO_SIDED|90.0|-4.6|14.24|||Wald's method Yates' continuity cor||The sample size for this study was calculated assuming that both active treatments would have equivalent success proportions of at least 55% and the Vehicle would have a success proportion no greater than 25%.|||14.24|-4.60|0.001
72509439|NCT01617434|144549724|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.19|||<|0.0001||95.0|-1.39|-0.99|||Mixed Models Analysis|||The null hypothesis of no difference between the two treatment arms with regard to changes from baseline in HbA1c (%) after 26 weeks of randomised treatment was analysed using a mixed model repeated measurements (MMRM) analysis with treatment, country, stratification groups as factors and baseline HbA1c as a covariate, all nested within visit.||-0.99|-1.39|<0.0001
72509440|NCT01617434|144549725|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.28|||<|0.0001||95.0|-1.7|-0.86|||Mixed Models Analysis|||The response was analysed using a mixed model repeated measurements (MMRM) analysis with treatment, country, stratification groups as factors and baseline as a covariate, all nested within visit.||-0.86|-1.70|<0.0001
72509441|NCT01617434|144549726|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.59|||<|0.0001||95.0|-2.01|-1.18|||Mixed Models Analysis|||The response was analysed using a mixed model repeated measurements (MMRM) analysis with treatment, country, stratification groups as factors and baseline as a covariate, all nested within visit.||-1.18|-2.01|<0.0001
72509442|NCT01617434|144549727|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.11|||<|0.0001||95.0|-3.85|-2.37|||Mixed Models Analysis|||The response was analysed using a mixed model repeated measurements (MMRM) analysis with treatment, country, stratification groups as factors and baseline as a covariate, all nested within visit.||-2.37|-3.85|<0.0001
72509443|NCT01617434|144549728|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|8.91|||<|0.0001||95.0|5.45|14.59|||Regression, Logistic|||This endpoint was analysed using a logistic regression model with treatment and stratification factors as fixed factors and the HbA1c value at baseline as a covariate. Subjects previously treated with insulin detemir without the use of metformin were not included in the analysis due to the small size of the stratum.||14.59|5.45|<0.0001
72509444|NCT01617434|144549729|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|20.12|||<|0.0001||95.0|9.92|40.84|||Regression, Logistic|||This endpoint was analysed using a logistic regression model with treatment and stratification factors as fixed factors and the HbA1c value at baseline as a covariate. Subjects previously treated with insulin detemir without the use of metformin were not included in the analysis due to the small size of the stratum.||40.84|9.92|<0.0001
72509445|NCT03283163|144549733|OTHER|||||||0.04|||||||t-test, 2 sided|||paired samples t-test to compare PTSD severity from baseline to endpoint (week 13).||||.040
72509446|NCT03283163|144549734|OTHER|||||||0.69|||||||t-test, 2 sided|||paired samples t-test to compare degree of pain-related interference from baseline to endpoint (week 13).||||.69
72509447|NCT03283163|144549735|OTHER|||||||0.098|||||||t-test, 2 sided|||paired samples t-test to compare severity of pain catastrophizing from baseline to endpoint (week 13).||||.098
72509448|NCT03283163|144549736|OTHER|||||||0.194|||||||t-test, 2 sided|||paired samples t-tests were conducted for comparison of resting ALLO+PA levels from baseline to endpoint (week 13).||||.194
72479567|NCT00706433|144485191|SUPERIORITY_OR_OTHER|||||||0.3916||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.3916
72479568|NCT00706433|144485192|SUPERIORITY_OR_OTHER|||||||0.8387||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.8387
72479569|NCT00706433|144485193|SUPERIORITY_OR_OTHER|||||||0.1489||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.1489
72509449|NCT03283163|144549737|OTHER|paired samples t-test||||||0.343|||||||t-test, 2 sided|||paired samples t-tests were conducted for comparison of peak ALLO+PA levels (30 minutes post MAXEX) from baseline to endpoint (week 13).||||.343
72509450|NCT04238663|144549749|EQUIVALENCE|"Two treatments are judged not to be different from one another if the 90% CI of the ratio of a log-transformed exposure measure (Cmax) falls completely within the range 0.80-1.25.~The PK parameter Cmax was log-transformed (base e) prior to analysis and was analysed using an ANCOVA model. The model included treatment as a fixed effect and body weight as a covariate."|Ratio of Geometric Least Square Mean|1.06|||||TWO_SIDED|90.0|0.976|1.16|||||For the comparison, MB02 represents the numerator and EU Avastin represents the denominator.|||1.16|0.976|
72509451|NCT04238663|144549749|EQUIVALENCE|"Two treatments are judged not to be different from one another if the 90% CI of the ratio of a log-transformed exposure measure (Cmax) falls completely within the range 0.80-1.25.~The PK parameter Cmax was log-transformed (base e) prior to analysis and was analysed using an ANCOVA model. The model included treatment as a fixed effect and body weight as a covariate."|Ratio of Geometric Least Square Mean|0.983|||||TWO_SIDED|90.0|0.897|1.08||||||For the comparison, MB02 represents the numerator and US Avastin represents the denominator.||1.08|0.897|
72479570|NCT00706433|144485194|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||<0.0001
72509452|NCT04238663|144549749|EQUIVALENCE|"Two treatments are judged not to be different from one another if the 90% CI of the ratio of a log-transformed exposure measure (Cmax) falls completely within the range 0.80-1.25.~The PK parameter Cmax was log-transformed (base e) prior to analysis and was analysed using an ANCOVA model. The model included treatment as a fixed effect and body weight as a covariate."|Ratio of Geometric Least Square Mean|0.926|||||TWO_SIDED|90.0|0.851|1.01|||||For Ratio of geometric least square mean (GLSM): EU is the numerator and US Avastin acts as the denominator|||1.01|0.851|
72576857|NCT00261443|144680662|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.12||||0.474|TWO_SIDED|95.0|-0.43|0.2||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 52 Comparison||0.20|-0.43|0.474
72479571|NCT00706433|144485194|SUPERIORITY_OR_OTHER|||||||0.4143||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.4143
72479572|NCT00706433|144485194|SUPERIORITY_OR_OTHER|||||||0.0005||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.0005
72479573|NCT00706433|144485194|SUPERIORITY_OR_OTHER|||||||0.0003||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.0003
72479574|NCT00706433|144485194|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||<0.0001
72509453|NCT04238663|144549750|EQUIVALENCE|"Two treatments are judged not to be different from one another if the 90% CI of the ratio of a log-transformed exposure measure (AUC) falls completely within the range 0.80-1.25.~The PK parameter AUC\[0-∞\] was log-transformed (base e) prior to analysis and was analysed using an ANCOVA model. The model included treatment as a fixed effect and body weight as a covariate."|Ratio of GLSM|1.07|||||TWO_SIDED|90.0|1.0|1.14|||||For the comparison, MB02 represents the numerator and EU Avastin represents the denominator|||1.14|1.00|
72509454|NCT04238663|144549750|EQUIVALENCE|"Two treatments are judged not to be different from one another if the 90% CI of the ratio of a log-transformed exposure measure (AUC) falls completely within the range 0.80-1.25.~The PK parameter AUC\[0-∞\] was log-transformed (base e) prior to analysis and was analysed using an ANCOVA model. The model included treatment as a fixed effect and body weight as a covariate."|Ratio of GLSM|0.998|||||TWO_SIDED|90.0|0.944|1.05|||||For the comparison, MB02 represents the numerator and US Avastin represents the denominator.|||1.05|0.944|
72509455|NCT04238663|144549750|EQUIVALENCE|"Two treatments are judged not to be different from one another if the 90% CI of the ratio of a log-transformed exposure measure (AUC) falls completely within the range 0.80-1.25.~The PK parameter AUC\[0-∞\] was log-transformed (base e) prior to analysis and was analysed using an ANCOVA model. The model included treatment as a fixed effect and body weight as a covariate."|Ratio of GLSM|0.934|||||TWO_SIDED|90.0|0.884|0.988|||||EU Avastin corresponds to the numerator and US Avastin corresponds to the denominator|||0.988|0.884|
72509456|NCT03259334|144549764|SUPERIORITY|||||||0.617|||||||Cochran-Mantel-Haenszel|P-value was based on Cochran-Mantel-Haenszel chi-square test stratified by actual status of prior anti-TNF treatment and glucocorticoid at baseline.||||||0.617
72509457|NCT03259334|144549764|SUPERIORITY|||||||0.018|||||||Cochran-Mantel-Haenszel|P-value was based on Cochran-Mantel-Haenszel chi-square test stratified by actual status of prior anti-TNF treatment and glucocorticoid at baseline.||||||0.018
72509458|NCT03259334|144549765|SUPERIORITY|||||||0.253|||||||Cochran-Mantel-Haenszel|P-value was based on Cochran-Mantel-Haenszel chi-square test stratified by actual status of prior anti-TNF treatment and glucocorticoid at baseline.||||||0.253
72479575|NCT00706433|144485194|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||<0.0001
72400289|NCT02246673|144308475|SUPERIORITY_OR_OTHER||Geometric Least Squares mean Ratio|-29.15|||<|0.0001|TWO_SIDED|95.0|-33.15|-25.15|||Mixed Models Analysis|The model included treatment and period as fixed effects and subject(s) as a random effect.||Cohort 2||-25.15|-33.15|<0.0001
72400290|NCT02246673|144308475|SUPERIORITY_OR_OTHER||Geometric Least Squares mean Ratio|-22.25|||<|0.0001|TWO_SIDED|95.0|-26.36|-18.14|||Mixed Models Analysis|The model included treatment and period as fixed effects and subject(s) as a random effect.||Cohort 2||-18.14|-26.36|<0.0001
72400291|NCT02246673|144308475|SUPERIORITY_OR_OTHER||Geometric Least Squares mean Ratio|-17.52|||<|0.0001|TWO_SIDED|95.0|-21.54|-13.5|||Mixed Models Analysis|The model included treatment and period as fixed effects and subject(s) as a random effect.||Cohort 3||-13.50|-21.54|<0.0001
72400292|NCT02246673|144308475|SUPERIORITY_OR_OTHER||Geometric Least Squares mean Ratio|-15.51|||<|0.0001|TWO_SIDED|95.0|-19.53|-11.49|||Mixed Models Analysis|The model included treatment and period as fixed effects and subject(s) as a random effect.||Cohort 3||-11.49|-19.53|<0.0001
72400293|NCT02246673|144308475|SUPERIORITY_OR_OTHER||Geometric Least Squares mean Ratio|-9.74|||<|0.0001|TWO_SIDED|95.0|-13.97|-5.51|||Mixed Models Analysis|The model included treatment and period as fixed effects and subject(s) as a random effect.||Cohort 4||-5.51|-13.97|<0.0001
72400294|NCT02246673|144308475|SUPERIORITY_OR_OTHER||Geometric Least Squares mean Ratio|-4.98||||0.0221|TWO_SIDED|95.0|-9.19|-0.76|||Mixed Models Analysis|The model included treatment and period as fixed effects and subject(s) as a random effect||Cohort 4||-0.76|-9.19|0.0221
72566581|NCT02985879|144663396|SUPERIORITY|The analysis utilized a likelihood-based, mixed-effects model, repeated measures (MMRM) analysis of the change from baseline for each postbaseline value and compared each ABBV-8E12 dose group with the placebo group. The model, which used all observed data, included fixed, categorical effects for treatment, site, visit, baseline score-by-visit interaction and treatment-by-visit interaction, with continuous fixed covariates for the corresponding baseline score.|LS Mean Difference|4.5|STANDARD_ERROR_OF_MEAN|3.88|=|0.243|TWO_SIDED|95.0|-3.11|12.19|||Mixed-effects model, repeated measures||ABBV-8E12 4000 mg - Placebo|ABBV-8E12 4000 mg vs Placebo||12.19|-3.11|=0.243
72400295|NCT02246673|144308475|SUPERIORITY_OR_OTHER||Geometric Least Squares mean Ratio|-35.38|||<|0.0001|TWO_SIDED|95.0|-38.89|-31.87|||Mixed Models Analysis|The model included treatment and period as fixed effects and subject(s) as a random effect.||Cohort 5||-31.87|-38.89|<0.0001
72400296|NCT02246673|144308475|SUPERIORITY_OR_OTHER||Geometric Least Squares mean Ratio|-27.08|||<|0.0001|TWO_SIDED|95.0|-30.6|-23.57|||Mixed Models Analysis|The model included treatment and period as fixed effects and subject(s) as a random effect.||Cohort 5||-23.57|-30.60|<0.0001
72400297|NCT02246673|144308475|SUPERIORITY_OR_OTHER||Geometric Least Squares mean Ratio|-31.26|||<|0.0001|TWO_SIDED|95.0|-34.77|-27.75|||Mixed Models Analysis|The model included treatment and period as fixed effects and subject(s) as a random effect.||Cohort 5||-27.75|-34.77|<0.0001
72400298|NCT02246673|144308476|SUPERIORITY_OR_OTHER||Geometric Least Squares mean Ratio|24.27||||0.0002|TWO_SIDED|95.0|12.57|35.98|||Mixed Models Analysis|The model included treatment and period as fixed effects and subject(s) as a random effect.||Cohort 1||35.98|12.57|0.0002
72400299|NCT02246673|144308476|SUPERIORITY_OR_OTHER||Geometric Least Squares mean Ratio|20.08||||0.0013|TWO_SIDED|95.0|8.38|31.79|||Mixed Models Analysis|The model included treatment and period as fixed effects and subject(s) as a random effect.||Cohort 1||31.79|8.38|0.0013
72400300|NCT02246673|144308476|SUPERIORITY_OR_OTHER||Geometric Least Squares mean Ratio|23.7|||<|0.0001|TWO_SIDED|95.0|14.23|33.17|||Mixed Models Analysis|The model included treatment and period as fixed effects and subject(s) as a random effect.||Cohort 2||33.17|14.23|<0.0001
72400301|NCT02246673|144308476|SUPERIORITY_OR_OTHER||Geometric Least Squares mean Ratio|18.37||||0.0008|TWO_SIDED|95.0|8.3|28.44|||Mixed Models Analysis|The model included treatment and period as fixed effects and subject(s) as a random effect.||Cohort 2||28.44|8.30|0.0008
72400302|NCT02246673|144308476|SUPERIORITY_OR_OTHER||Geometric Least Squares mean Ratio|18.82||||0.0101|TWO_SIDED|95.0|4.86|32.79|||Mixed Models Analysis|The model included treatment and period as fixed effects and subject(s) as a random effect.||Cohort 3||32.79|4.86|0.0101
72400303|NCT02246673|144308476|SUPERIORITY_OR_OTHER||Geometric Least Squares mean Ratio|20.52||||0.0055|TWO_SIDED|95.0|6.56|34.48|||Mixed Models Analysis|The model included treatment and period as fixed effects and subject(s) as a random effect.||Cohort 3||34.48|6.56|0.0055
72400304|NCT02246673|144308476|SUPERIORITY_OR_OTHER||Geometric Least Squares mean Ratio|10.36||||0.0065|TWO_SIDED|95.0|3.13|17.59|||Mixed Models Analysis|The model included treatment and period as fixed effects and subject(s) as a random effect.||Cohort 4||17.59|3.13|0.0065
72479576|NCT00706433|144485194|SUPERIORITY_OR_OTHER|||||||0.97||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.9700
72479577|NCT00706433|144485195|SUPERIORITY_OR_OTHER|||||||0.2544||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.2544
72479578|NCT00706433|144485196|SUPERIORITY_OR_OTHER|||||||0.4321||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.4321
72479579|NCT00706433|144485197|SUPERIORITY_OR_OTHER|||||||0.0317||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.0317
72479580|NCT00706433|144485197|SUPERIORITY_OR_OTHER|||||||0.5818||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.5818
72400305|NCT02246673|144308476|SUPERIORITY_OR_OTHER||Geometric Least Squares mean Ratio|1.79||||0.614|TWO_SIDED|95.0|-5.37|8.94|||Mixed Models Analysis|The model included treatment and period as fixed effects and subject(s) as a random effect||Cohort 4||8.94|-5.37|0.6140
72400306|NCT02246673|144308476|SUPERIORITY_OR_OTHER||Geometric Least Squares mean Ratio|30.83||||0.0002|TWO_SIDED|95.0|15.62|46.04|||Mixed Models Analysis|The model included treatment and period as fixed effects and subject(s) as a random effect.||Cohort 5||46.04|15.62|0.0002
72400307|NCT02246673|144308476|SUPERIORITY_OR_OTHER||Geometric Least Squares mean Ratio|24.38||||0.0019|TWO_SIDED|95.0|9.63|39.14|||Mixed Models Analysis|The model included treatment and period as fixed effects and subject(s) as a random effect.||Cohort 5||39.14|9.63|0.0019
72400308|NCT02246673|144308476|SUPERIORITY_OR_OTHER||Geometric Least Squares mean Ratio|26.35||||0.0009|TWO_SIDED|95.0|11.59|41.11|||Mixed Models Analysis|The model included treatment and period as fixed effects and subject(s) as a random effect.||Cohort 5||41.11|11.59|0.0009
72400309|NCT02246673|144308477|SUPERIORITY_OR_OTHER||Geometric Least Squares mean Ratio|139.11|||<|0.0001|TWO_SIDED|95.0|93.92|184.31|||Mixed Models Analysis|The model included treatment and period as fixed effects and subject(s) as a random effect.||Cohort 1||184.31|93.92|<0.0001
72400310|NCT02246673|144308477|SUPERIORITY_OR_OTHER||Geometric Least Squares mean Ratio|174.47|||<|0.0001|TWO_SIDED|95.0|125.52|233.42|||Mixed Models Analysis|The model included treatment and period as fixed effects and subject(s) as a random effect.||Cohort 1||233.42|125.52|<0.0001
72400311|NCT02246673|144308477|SUPERIORITY_OR_OTHER||Geometric Least Squares mean Ratio|168.03|||<|0.0001|TWO_SIDED|95.0|123.13|212.93|||Mixed Models Analysis|The model included treatment and period as fixed effects and subject(s) as a random effect.||Cohort 2||212.93|123.13|<0.0001
72400312|NCT02246673|144308477|SUPERIORITY_OR_OTHER||Geometric Least Squares mean Ratio|188.75|||<|0.0001|TWO_SIDED|95.0|138.04|239.46|||Mixed Models Analysis|The model included treatment and period as fixed effects and subject(s) as a random effect.||Cohort 2||239.46|138.04|<0.0001
72400313|NCT02246673|144308477|SUPERIORITY_OR_OTHER||Geometric Least Squares mean Ratio|70.43||||0.0005|TWO_SIDED|95.0|33.74|107.12|||Mixed Models Analysis|The model included treatment and period as fixed effects and subject(s) as a random effect.||Cohort 3||107.12|33.74|0.0005
72400314|NCT02246673|144308477|SUPERIORITY_OR_OTHER||Geometric Least Squares mean Ratio|91.5|||<|0.0001|TWO_SIDED|95.0|54.81|128.19|||Mixed Models Analysis|The model included treatment and period as fixed effects and subject(s) as a random effect.||Cohort 3||128.19|54.81|<0.0001
72400315|NCT02246673|144308477|SUPERIORITY_OR_OTHER||Geometric Least Squares mean Ratio|40.11|||<|0.0001|TWO_SIDED|95.0|25.17|55.05|||Mixed Models Analysis|The model included treatment and period as fixed effects and subject(s) as a random effect.||Cohort 4||55.05|25.17|<0.0001
72400316|NCT02246673|144308477|SUPERIORITY_OR_OTHER||Geometric Least Squares mean Ratio|15.96||||0.035|TWO_SIDED|95.0|1.2|30.71|||Mixed Models Analysis|The model included treatment and period as fixed effects and subject(s) as a random effect.||Cohort 4||30.71|1.20|0.0350
72400317|NCT02246673|144308477|SUPERIORITY_OR_OTHER||Geometric Least Squares mean Ratio|236.08|||<|0.0001|TWO_SIDED|95.0|178.29|293.86|||Mixed Models Analysis|The model included treatment and period as fixed effects and subject(s) as a random effect.||Cohort 5||293.86|178.29|<0.0001
72400318|NCT02246673|144308477|SUPERIORITY_OR_OTHER||Geometric Least Squares mean Ratio|146.2|||<|0.0001|TWO_SIDED|95.0|90.4|202.01|||Mixed Models Analysis|The model included treatment and period as fixed effects and subject(s) as a random effect.||Cohort 5||202.01|90.40|<0.0001
72400319|NCT02246673|144308477|SUPERIORITY_OR_OTHER||Geometric Least Squares mean Ratio|176.57|||<|0.0001|TWO_SIDED|95.0|120.77|232.38|||Mixed Models Analysis|The model included treatment and period as fixed effects and subject(s) as a random effect.||Cohort 5||232.38|120.77|<0.0001
72400320|NCT02246673|144308478|SUPERIORITY_OR_OTHER||Geometric Least Squares mean Ratio|135.82|||<|0.0001|TWO_SIDED|95.0|93.33|178.32|||Mixed Models Analysis|The model included treatment and period as fixed effects and subject(s) as a random effect.||Cohort 1||178.32|93.33|<0.0001
72400321|NCT02246673|144308478|SUPERIORITY_OR_OTHER||Geometric Least Squares mean Ratio|178.58|||<|0.0001|TWO_SIDED|95.0|129.25|227.9|||Mixed Models Analysis|The model included treatment and period as fixed effects and subject(s) as a random effect.||Cohort 1||227.90|129.25|<0.0001
72400322|NCT02246673|144308478|SUPERIORITY_OR_OTHER||Geometric Least Squares mean Ratio|163.98|||<|0.0001|TWO_SIDED|95.0|120.8|207.16|||Mixed Models Analysis|The model included treatment and period as fixed effects and subject(s) as a random effect.||Cohort 2||207.16|120.80|<0.0001
72400323|NCT02246673|144308478|SUPERIORITY_OR_OTHER||Geometric Least Squares mean Ratio|169.93|||<|0.0001|TWO_SIDED|95.0|122.82|217.03|||Mixed Models Analysis|The model included treatment and period as fixed effects and subject(s) as a random effect.||Cohort 2||217.03|122.82|<0.0001
72400324|NCT02246673|144308478|SUPERIORITY_OR_OTHER||Geometric Least Squares mean Ratio|59.6||||0.0007|TWO_SIDED|95.0|28.85|90.34|||Mixed Models Analysis|The model included treatment and period as fixed effects and subject(s) as a random effect.||Cohort 3||90.34|28.85|0.0007
72400325|NCT02246673|144308478|SUPERIORITY_OR_OTHER||Geometric Least Squares mean Ratio|73.54|||<|0.0001|TWO_SIDED|95.0|42.79|104.28|||Mixed Models Analysis|The model included treatment and period as fixed effects and subject(s) as a random effect.||Cohort 3||104.28|42.79|<0.0001
72400326|NCT02246673|144308478|SUPERIORITY_OR_OTHER||Geometric Least Squares mean Ratio|33.7|||<|0.0001|TWO_SIDED|95.0|21.21|46.2|||Mixed Models Analysis|The model included treatment and period as fixed effects and subject(s) as a random effect.||Cohort 4||46.20|21.21|<0.0001
72509459|NCT03259334|144549765|SUPERIORITY|||||||0.002|||||||Cochran-Mantel-Haenszel|P-value was based on Cochran-Mantel-Haenszel chi-square test stratified by actual status of prior anti-TNF treatment and glucocorticoid at baseline.||||||0.002
72509460|NCT03259334|144549766|SUPERIORITY|||||||0.764|||||||Cochran-Mantel-Haenszel|P-value was based on Cochran-Mantel-Haenszel chi-square test stratified by actual status of prior anti-TNF treatment and glucocorticoid at baseline||||||0.764
72509461|NCT03259334|144549766|SUPERIORITY|||||||0.08|||||||Cochran-Mantel-Haenszel|P-value was based on Cochran-Mantel-Haenszel chi-square test stratified by actual status of prior anti-TNF treatment and glucocorticoid at baseline.||||||0.080
72509462|NCT03259334|144549767|SUPERIORITY|||||||0.44|||||||Cochran-Mantel-Haenszel|P-value was based on Cochran-Mantel-Haenszel chi-square test stratified by actual status of prior anti-TNF treatment and glucocorticoid at baseline.||||||0.440
72509463|NCT03259334|144549767|SUPERIORITY|||||||0.002|||||||Cochran-Mantel-Haenszel|P-value was based on Cochran-Mantel-Haenszel chi-square test stratified by actual status of prior anti-TNF treatment and glucocorticoid at baseline||||||0.002
72400327|NCT02246673|144308478|SUPERIORITY_OR_OTHER||Geometric Least Squares mean Ratio|27.08||||0.0001|TWO_SIDED|95.0|14.58|39.58|||Mixed Models Analysis|The model included treatment and period as fixed effects and subject(s) as a random effect.||Cohort 4||39.58|14.58|0.0001
72400328|NCT02246673|144308478|SUPERIORITY_OR_OTHER||Geometric Least Squares mean Ratio|188.83|||<|0.0001|TWO_SIDED|95.0|152.55|225.1|||Mixed Models Analysis|The model included treatment and period as fixed effects and subject(s) as a random effect.||Cohort 5||225.10|152.55|<0.0001
72509464|NCT03259334|144549768|SUPERIORITY|||||||0.286|||||||Cochran-Mantel-Haenszel|P-value was based on Cochran-Mantel-Haenszel chi-square test stratified by actual status of prior anti-TNF treatment and glucocorticoid at baseline||||||0.286
72509465|NCT03259334|144549768|SUPERIORITY|||||||0.005|||||||Cochran-Mantel-Haenszel|P-value was based on Cochran-Mantel-Haenszel chi-square test stratified by actual status of prior anti-TNF treatment and glucocorticoid at baseline.||||||0.005
72509466|NCT00701727|144549788|SUPERIORITY_OR_OTHER|||||||0.019|||||||t-test, 2 sided|||||||0.019
72509467|NCT00701727|144549789|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
72509468|NCT00701727|144549790|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||||||<0.001
72509469|NCT00701727|144549791|SUPERIORITY_OR_OTHER|||||||0.12|||||||t-test, 2 sided|||||||0.12
72509470|NCT00701727|144549792|SUPERIORITY_OR_OTHER||||||>|0.05|||||||t-test, 2 sided|||||||>0.05
72509471|NCT00701727|144549793|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
72509472|NCT00701727|144549794|SUPERIORITY_OR_OTHER|||||||0.95|||||||t-test, 2 sided|||||||0.95
72509473|NCT05113953|144549805|SUPERIORITY||Treatment Difference|-0.42||||0.1893|TWO_SIDED|95.0|-1.06|0.21||P-value was analysed by MMRM method with change from baseline in binge eating days per week at scheduled visit as dependent variable and included fixed effect terms for treatment, trial center, visit week, interaction term of treatment by visit week.|MMRM|||||0.21|-1.06|0.1893
72509474|NCT05113953|144549805|SUPERIORITY||Treatment Difference|-0.06||||0.8502|TWO_SIDED|95.0|-0.69|0.57||P-value was analysed by MMRM method with change from baseline in binge eating days per week at scheduled visit as dependent variable and included fixed effect terms for treatment, trial center, visit week, interaction term of treatment by visit week.|MMRM|||||0.57|-0.69|0.8502
72400329|NCT02246673|144308478|SUPERIORITY_OR_OTHER||Geometric Least Squares mean Ratio|116.83|||<|0.0001|TWO_SIDED|95.0|81.76|151.9|||Mixed Models Analysis|The model included treatment and period as fixed effects and subject(s) as a random effect.||Cohort 5||151.90|81.76|<0.0001
72400330|NCT02246673|144308478|SUPERIORITY_OR_OTHER||Geometric Least Squares mean Ratio|151.66|||<|0.0001|TWO_SIDED|95.0|116.59|186.73|||Mixed Models Analysis|The model included treatment and period as fixed effects and subject(s) as a random effect.||Cohort 5||186.73|116.59|<0.0001
72400331|NCT05413369|144308508|NON_INFERIORITY|The non-inferiority was assessed using the upper bound of the 2-sided 95% confidence interval (CI). Non-inferiority p-value was calculated from a non-inferiority margin of 0.3%.|Least Squares (LS) Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|95.0|-0.33|-0.07|||ANCOVA|Treatment groups and randomization stratum of previous oral anti-diabetic drug(OADs) as fixed effects,and baseline HbA1c continuous value as covariate||Statistical analysis for change from baseline in HbA1c||-0.07|-0.33|<0.001
72400332|NCT05413369|144308509|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.07||0.003|TWO_SIDED|97.5|-0.35|-0.05|||ANCOVA|Treatment groups and randomization stratum of previous as fixed effects, and baseline HbA1c continuous value as covariate||Statistical analysis for change from baseline in HbA1c||-0.05|-0.35|0.003
72400333|NCT05413369|144308510|SUPERIORITY||LS Mean Difference|-1.49|STANDARD_ERROR_OF_MEAN|0.37|<|0.001|TWO_SIDED|97.5|-2.32|-0.66|||ANCOVA|Treatment groups, randomization stratums of HbA1c and previous OADs as fixed effects, and baseline body weight continuous value as covariate.||Statistical analysis for change from baseline in body weight||-0.66|-2.32|<0.001
72400334|NCT05413369|144308511|SUPERIORITY||Odds Ratio (OR)|1.89|||<|0.001|TWO_SIDED|97.5|1.25|2.85|||Regression, Logistic|Adjusted for treatment group, randomization stratum of previous OADs, and continuous baseline value of HbA1c||Statistical analysis for percentage of participants reaching HbA1c value \<7% at Week 24||2.85|1.25|<0.001
72400335|NCT05413369|144308512|SUPERIORITY||Odds Ratio (OR)|2.59|||<|0.001|TWO_SIDED|95.0|1.79|3.76|||Regression, Logistic|Adjusted for treatment group, randomization stratum of previous OADs, and continuous baseline value of HbA1c and body weight.||Statistical analysis for percentage of participants reaching HbA1c value \<7% with no body weight gain at Week 24||3.76|1.79|<0.001
72400336|NCT05413369|144308513|SUPERIORITY||Odds Ratio (OR)|2.34|||<|0.001|TWO_SIDED|95.0|1.52|3.6|||Regression, Logistic|Adjusted for treatment group, randomization stratum of previous OADs, and continuous baseline value of HbA1c and body weight.||Statistical analysis for percentage of participants reaching HbA1c value \<7% with no body weight gain at Week 24 and no hypoglycemia during treatment||3.60|1.52|<0.001
72400337|NCT00720057|144308527|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||The treatment differences between the two groups were tested each at the 5% two-sided significant level using a hierarchal testing procedure to control the overall type 1 error. SPID16-24 was eligible for testing only after a statistically significant difference between the two arms with respect to SPID0-24 was observed. The SPIDs were analyzed via ANCOVA model with treatment and trial site as fixed effects and baseline pain intensity score as the covariate.||||<0.001
72509475|NCT05113953|144549806|SUPERIORITY||Treatment Difference|-0.54||||0.0313|TWO_SIDED|95.0|-1.02|-0.05||P-value was analysed by MMRM method with change from baseline value as dependent variable and included treatment, trial center, visit week, treatment-by-week interaction as fixed effects and baseline-by-week interaction as covariates.|MMRM|||Change from baseline at Week 8||-0.05|-1.02|0.0313
72509476|NCT05113953|144549806|SUPERIORITY||Treatment Difference|0.19||||0.4471|TWO_SIDED|95.0|-0.3|0.67||P-value was analysed by MMRM method with change from baseline value as dependent variable and included treatment, trial center, visit week, treatment-by-week interaction as fixed effects and baseline-by-week interaction as covariates.|MMRM|||Change from baseline at Week 8||0.67|-0.30|0.4471
72400338|NCT00720057|144308528|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||||||<0.001
72400339|NCT00720057|144308529|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||||||<0.001
72400340|NCT00720057|144308530|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Log Rank|||The statistics are from the Kaplan-Meier method. The median for naproxen treatment arm was not estimable from Kaplan-Meier method, therefore it is presented as the maximum value from the full range.||||<0.001
72400341|NCT00720057|144308531|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel|||||||<0.001
72400342|NCT00720057|144308532|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Log Rank|||||||<0.001
72400343|NCT03559257|144308593|SUPERIORITY||LSMean Difference|-3.12|STANDARD_ERROR_OF_MEAN|0.41|<|0.0001|TWO_SIDED|95.0|-3.92|-2.32|||Mixed Models Analysis|||||-2.32|-3.92|<0.0001
72509477|NCT05137041|144549872|SUPERIORITY|||||||0.002|||||||Fisher Exact|||||||0.002
72509478|NCT05137041|144549874|SUPERIORITY||Least Square Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.17||0.015|TWO_SIDED|95.0|-0.817|-0.137|||ANCOVA|The p-value was adjusted using a False Discovery Rate approach (Benjamini-Hochberg).||||-0.137|-0.817|0.015
72509479|NCT05137041|144549875|SUPERIORITY||Least Square Mean Difference|-15.9|STANDARD_ERROR_OF_MEAN|8.47||0.103|TWO_SIDED|95.0|-32.661|0.828||The p-value was adjusted using a False Discovery Rate approach (Benjamini-Hochberg).|ANCOVA|||||0.828|-32.661|0.103
72509480|NCT05137041|144549876|SUPERIORITY||Least Square Mean Difference|1.0|STANDARD_ERROR_OF_MEAN|0.27|<|0.001|TWO_SIDED|95.0|0.511|1.581||The p-value was adjusted using a False Discovery Rate approach (Benjamini-Hochberg).|ANCOVA|||||1.581|0.511|<0.001
72509481|NCT05137041|144549877|SUPERIORITY||Least Square Mean Difference|-1.4|STANDARD_ERROR_OF_MEAN|0.82||0.121|TWO_SIDED|95.0|-2.976|0.25||The p-value was adjusted using a False Discovery Rate approach (Benjamini-Hochberg).|ANCOVA|||||0.250|-2.976|0.121
72509482|NCT05137041|144549878|SUPERIORITY|||||||0.564||||||The p-value is adjusted using a False Discovery Rate approach (Benjamini-Hochberg).|Log Rank|||||||0.564
72509483|NCT05137041|144549879|SUPERIORITY|||||||0.289|||||||Log Rank|||||||0.289
72509484|NCT05137041|144549880|SUPERIORITY|||||||0.001|||||||Satterthwaite t-test|||Change from Baseline at Day 1 Evening||||0.001
72400344|NCT03559257|144308594|SUPERIORITY||LSMean Difference|-2.57|STANDARD_ERROR_OF_MEAN|0.43|<|0.0001|TWO_SIDED|95.0|-3.41|-1.72|||Mixed Models Analysis|||||-1.72|-3.41|<0.0001
72400345|NCT03559257|144308595|SUPERIORITY||Odds Ratio (OR)|3.935|||<|0.0001|TWO_SIDED|95.0|2.719|5.693|||pseudo likelihood-based repeated measure|||||5.693|2.719|<0.0001
72400346|NCT03559257|144308596|SUPERIORITY||Odds Ratio (OR)|3.481|||<|0.0001|TWO_SIDED|95.0|2.252|5.381|||Pseudo likelihood-based repeated measure|||||5.381|2.252|<0.0001
72509485|NCT05137041|144549880|SUPERIORITY|||||||0.035|||||||Satterthwaite t-test|||Change from Baseline at Day 2 Morning||||0.035
72623650|NCT00600340|144778109|SUPERIORITY|HR is the hazard rate of Bevacizumab Plus Capecitabine divided by hazard rate of Bevacizumab plus Paclitaxel.|Hazard Ratio (HR)|1.32||||0.0066|TWO_SIDED|95.0|1.08|1.61|||Log Rank|Two-sided log-rank test adjusted by stratification factors at randomization|HR is the hazard rate of Bevacizumab Plus Capecitabine divided by hazard rate of Bevacizumab plus Paclitaxel.|"HR of Bevacizumab Plus Capecitabine vs. Bevacizumab plus Paclitaxel for PFS (stratified)~Based on Cox proportional hazards model adjusted by stratification factors at randomization:~1. estrogen and/or progesterone status (positive vs. other)~2. country~3. menopausal status (premenopausal or male \<=50 years of age vs. postmenopausal or male \>50 years of age)"||1.61|1.08|0.0066
72623651|NCT00600340|144778110|SUPERIORITY|HR is the hazard rate of Bevacizumab plus Capecitabine divided by hazard rate of Bevacizumab plus Paclitaxel.|Hazard Ratio (HR)|1.31||||0.0094|TWO_SIDED|95.0|1.07|1.61|||Log Rank|Two-sided log-rank test adjusted by stratification factors at randomization|HR is the hazard rate of Bevacizumab plus Capecitabine divided by hazard rate of Bevacizumab plus Paclitaxel.|"HR of Bevacizumab plus Capecitabine vs. Bevacizumab plus Paclitaxel for PFS (stratified)~Based on Cox proportional hazards model adjusted by stratification factors at randomization:~1. estrogen and/or progesterone status (positive vs. other)~2. country~3. menopausal status (premenopausal or male \<=50 years of age vs. postmenopausal or male \>50 years of age)"||1.61|1.07|0.0094
72623652|NCT00600340|144778111|SUPERIORITY|HR is the hazard rate of Bevacizumab plus Capecitabine divided by hazard rate of Bevacizumab plus Paclitaxel.|Hazard Ratio (HR)|1.13||||0.1957|TWO_SIDED|95.0|0.94|1.35||Two-sided log-rank test adjusted by stratification factors at randomization|Log Rank||HR is the hazard rate of Bevacizumab plus Capecitabine divided by hazard rate of Bevacizumab plus Paclitaxel.|"HR of Bevacizumab plus Capecitabine vs. Bevacizumab plus Paclitaxel for TTF (stratified)~Based on Cox proportional hazards model adjusted by stratification factors at randomization:~1. estrogen and/or progesterone status (positive vs. other)~2. country~3. menopausal status (premenopausal or male \<=50 years of age vs. postmenopausal or male \>50 years of age)"||1.35|0.94|0.1957
72400347|NCT03559257|144308597|SUPERIORITY||LSMean Difference|12.53|STANDARD_ERROR_OF_MEAN|1.7|<|0.0001|TWO_SIDED|95.0|9.19|15.87|||Mixed Models Analysis|||||15.87|9.19|<0.0001
72623653|NCT00600340|144778112|SUPERIORITY|HR is the hazard rate of Bevacizumab plus Capecitabine divided by hazard rate of Bevacizumab plus Paclitaxel.|Hazard Ratio (HR)|1.11||||0.2583|TWO_SIDED|95.0|0.92|1.34||Two-sided log-rank test adjusted by stratification factors at randomization|Log Rank||HR is the hazard rate of Bevacizumab plus Capecitabine divided by hazard rate of Bevacizumab plus Paclitaxel.|"HR of Bevacizumab plus Capecitabine vs. Bevacizumab plus Paclitaxel for TTF (stratified)~Based on Cox proportional hazards model adjusted by stratification factors at randomization:~1. estrogen and/or progesterone status (positive vs. other)~2. country~3. menopausal status (premenopausal or male \<=50 years of age vs. postmenopausal or male \>50 years of age)"||1.34|0.92|0.2583
72623654|NCT00600340|144778113|SUPERIORITY|HR is the hazard rate of Bevacizumab Plus Capecitabine divided by hazard rate of Bevacizumab plus Paclitaxel.|Hazard Ratio (HR)|0.57||||0.0001|TWO_SIDED|95.0|0.43|0.77||Two-sided log-rank test adjusted by stratification factors at randomization|Log Rank||HR is the hazard rate of Bevacizumab Plus Capecitabine divided by hazard rate of Bevacizumab plus Paclitaxel.|"HR of Bevacizumab Plus Capecitabine vs. Bevacizumab plus Paclitaxel for TR (stratified)~Based on Cox proportional hazards model adjusted by stratification factors at randomization:~1. estrogen and/or progesterone status (positive vs. other)~2. country~3. menopausal status (premenopausal or male \<=50 years of age vs. postmenopausal or male \>50 years of age)"||0.77|0.43|0.0001
72400348|NCT03559257|144308598|SUPERIORITY||LSMean Difference|11.51|STANDARD_ERROR_OF_MEAN|2.22|<|0.0001|TWO_SIDED|95.0|7.14|15.89|||Mixed Models Analysis|||||15.89|7.14|<0.0001
72400349|NCT03559257|144308599|SUPERIORITY||Odds Ratio (OR)|5.878||||0.0001|TWO_SIDED|95.0|2.374|14.554|||Pseudo likelihood-based repeated measure|||||14.554|2.374|0.0001
72400350|NCT03559257|144308600|SUPERIORITY||Odds Ratio (OR)|999.999|||<|0.0001|TWO_SIDED|95.0|548.706|999.999|||Pseudo likelihood-based repeated measure||Estimated value and upper bound are \>999.999|||999.999|548.706|<0.0001
72400351|NCT03559257|144308601|SUPERIORITY||Odds Ratio (OR)|5.012|||<|0.0001|TWO_SIDED|95.0|2.352|10.679|||pseudo likelihood-based repeated measure|||||10.679|2.352|<0.0001
72400352|NCT03559257|144308602|SUPERIORITY||Odds Ratio (OR)|999.99|||<|0.0001|TWO_SIDED|95.0|999.99|999.99|||Pseudo likelihood-based repeated measure||Point estimate, upper limit and lower limit are \>999.99|||999.99|999.99|<0.0001
72400353|NCT03559257|144308603|SUPERIORITY||LSMean Difference|-3.4|STANDARD_ERROR_OF_MEAN|0.38|<|0.0001|TWO_SIDED|95.0|-4.14|-2.65|||Mixed Models Analysis|||||-2.65|-4.14|<0.0001
72400354|NCT03559257|144308604|SUPERIORITY||LSMean Difference|-3.13|STANDARD_ERROR_OF_MEAN|0.42|<|0.0001|TWO_SIDED|95.0|-3.96|-2.29|||Mixed Models Analysis|||||-2.29|-3.96|<0.0001
72400355|NCT03559257|144308605|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
72509486|NCT05137041|144549880|SUPERIORITY|||||||0.004|||||||Satterthwaite t-test|||Change from Baseline at Day 2 Evening||||0.004
72509487|NCT05137041|144549880|SUPERIORITY|||||||0.007|||||||Satterthwaite t-test|||Change from Baseline at Day 3 Morning||||0.007
72509488|NCT05137041|144549880|SUPERIORITY|||||||0.005|||||||Satterthwaite t-test|||Change from Baseline at Day 3 Evening||||0.005
72509489|NCT05137041|144549880|SUPERIORITY|||||||0.001|||||||Satterthwaite t-test|||Change from Baseline at Day 4 Morning||||0.001
72509490|NCT05137041|144549880|SUPERIORITY|||||||0.007|||||||Satterthwaite t-test|||Change from Baseline at Day 4 Evening||||0.007
72509491|NCT05137041|144549880|SUPERIORITY|||||||0.096|||||||Satterthwaite t-test|||Change from Baseline at Day 5 Morning||||0.096
72509492|NCT05137041|144549880|SUPERIORITY|||||||0.015|||||||Satterthwaite t-test|||Change from Baseline at Day 5||||0.015
72400356|NCT03559257|144308606|SUPERIORITY||LSMean Difference|-1.06|STANDARD_ERROR_OF_MEAN|0.27|<|0.0001|TWO_SIDED|95.0|-1.58|-0.54|||Mixed Models Analysis|||||-0.54|-1.58|<0.0001
72400357|NCT03559257|144308607|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||Activity Impairment.||||<0.0001
72400358|NCT03559257|144308607|SUPERIORITY|||||||0.388|||||||ANCOVA|||Absenteeism.||||0.3880
72400359|NCT03559257|144308607|SUPERIORITY|||||||0.0004|||||||ANCOVA|||Presenteeism.||||0.0004
72400360|NCT03559257|144308607|SUPERIORITY|||||||0.0003|||||||ANCOVA|||Work impairment.||||0.0003
72400361|NCT03559257|144308608|SUPERIORITY|||||||0.0003|||||||ANCOVA|||||||0.0003
72400362|NCT03559257|144308609|SUPERIORITY|||||||0.1267|||||||ANCOVA|||||||0.1267
72400363|NCT03559257|144308610|SUPERIORITY|||||||0.163|||||||ANCOVA|||||||0.1630
72400364|NCT03559257|144308611|SUPERIORITY|||||||0.0277|||||||ANCOVA|||||||0.0277
72400365|NCT03194555|144308650|SUPERIORITY||Risk Difference (RD)|-2.17||||0.4267|TWO_SIDED|95.0|-3.67|8.01|||Chi-squared|||||8.01|-3.67|0.4267
72400366|NCT03194555|144308651|SUPERIORITY||Risk Difference (RD)|2.0||||0.268|TWO_SIDED|95.0|-18.46|66.83|||Chi-squared|||||66.83|-18.46|0.268
72400367|NCT03194555|144308652|SUPERIORITY||Risk Difference (RD)|3.0||||0.0926|TWO_SIDED|95.0|-17.2|67.4|||Chi-squared|||||67.4|-17.2|0.0926
72400368|NCT03194555|144308653|SUPERIORITY||Risk Difference (RD)|2.0||||0.2894|TWO_SIDED|95.0|-17.2|67.4|||Chi-squared|||||67.4|-17.2|0.2894
72400369|NCT03194555|144308654|SUPERIORITY||Risk Difference (RD)|-1.83||||0.5724|TWO_SIDED|95.0|-5.1557|8.8157|||Chi-squared|||||8.8157|-5.1557|0.5724
72400370|NCT03194555|144308655|SUPERIORITY||Risk Difference (RD)|-9.84||||0.2998|TWO_SIDED|95.0|-11.15|30.83|||Chi-squared|||||30.83|-11.15|0.2998
72400371|NCT03194555|144308656|SUPERIORITY||Risk Difference (RD)|-11.67||||0.2673|TWO_SIDED||||||Chi-squared|||||||0.2673
72400372|NCT03194555|144308659|SUPERIORITY||Risk Difference (RD)|28.76||||0.3527|TWO_SIDED|95.0|-94.5005|36.9805|||Chi-squared|||||36.9805|-94.5005|0.3527
72400373|NCT03194555|144308660|SUPERIORITY||Risk Difference (RD)|-1.95||||0.5246|TWO_SIDED||||||Chi-squared|||||||0.5246
72400374|NCT03194555|144308662|SUPERIORITY||Risk Difference (RD)|0.34||||0.8649|TWO_SIDED||||||Chi-squared|||||||0.8649
72400375|NCT03760146|144308713|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the geometric mean ratio (GMR) for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|0.8|||||TWO_SIDED|95.0|0.71|0.9||||||Serotype 1: Geometric mean ratio (20vPnC/Saline vs 13vPnC/PPSV23) and the 2-sided 95% CI||0.90|0.71|
72400376|NCT03760146|144308713|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|0.85|||||TWO_SIDED|95.0|0.78|0.93||||||Serotype 3: Geometric mean ratio (20vPnC/Saline vs 13vPnC/PPSV23) and the 2-sided 95% CI||0.93|0.78|
72400377|NCT03760146|144308713|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|0.81|||||TWO_SIDED|95.0|0.71|0.93||||||Serotype 4: Geometric mean ratio (20vPnC/Saline vs 13vPnC/PPSV23) and the 2-sided 95% CI||0.93|0.71|
72400378|NCT03760146|144308713|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|0.83|||||TWO_SIDED|95.0|0.74|0.94||||||Serotype 5: Geometric mean ratio (20vPnC/Saline vs 13vPnC/PPSV23) and the 2-sided 95% CI||0.94|0.74|
72400379|NCT03760146|144308713|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|0.76|||||TWO_SIDED|95.0|0.66|0.88||||||Serotype 6A: Geometric mean ratio (20vPnC/Saline vs 13vPnC/PPSV23) and the 2-sided 95% CI||0.88|0.66|
72400380|NCT03760146|144308713|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|0.83|||||TWO_SIDED|95.0|0.73|0.95||||||Serotype 6B: Geometric mean ratio (20vPnC/Saline vs 13vPnC/PPSV23) and the 2-sided 95% CI||0.95|0.73|
72509493|NCT05137041|144549881|SUPERIORITY||||||<|0.001|||||||Satterthwaite t-test|||VRS: Day 1 Evening||||<0.001
72509494|NCT05137041|144549881|SUPERIORITY|||||||0.001|||||||Satterthwaite t-test|||VRS: Day 2 Morning||||0.001
72509495|NCT05137041|144549881|SUPERIORITY||||||<|0.001|||||||Satterthwaite t-test|||VRS: Day 2 Evening||||<0.001
72509496|NCT05137041|144549881|SUPERIORITY||||||<|0.001|||||||Satterthwaite t-test|||VRS: Day 3 Morning||||<0.001
72509497|NCT05137041|144549881|SUPERIORITY||||||<|0.001|||||||Satterthwaite t-test|||VRS: Day 3 Evening||||<0.001
72509498|NCT05137041|144549881|SUPERIORITY||||||<|0.001|||||||Satterthwaite t-test|||VRS: Day 4 Morning||||<0.001
72509499|NCT05137041|144549881|SUPERIORITY||||||<|0.001|||||||Satterthwaite t-test|||VRS: Day 4 Evening||||<0.001
72509500|NCT05137041|144549881|SUPERIORITY|||||||0.024|||||||Satterthwaite t-test|||VRS: Day 5 Morning||||0.024
72509501|NCT05137041|144549881|SUPERIORITY||||||<|0.001|||||||Satterthwaite t-test|||VRS: Day 5||||<0.001
72509502|NCT05137041|144549882|SUPERIORITY||Least Square Mean Difference|0.7|STANDARD_ERROR_OF_MEAN|0.12|<|0.001|TWO_SIDED|95.0|0.415|0.903|||ANCOVA|||||0.903|0.415|<0.001
72509503|NCT02626819|144549883|SUPERIORITY||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|Weight change was analyzed using Wilcoxon Rank-Sum test along with multiple imputation to adjust for missing data||||||<0.05
72509504|NCT02626819|144549884|SUPERIORITY||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|Weight change was analyzed using Wilcoxon Rank-Sum test along with multiple imputation to adjust for missing data.||||||<0.05
72509505|NCT02626819|144549885|SUPERIORITY||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|Weight change was analyzed using Wilcoxon Rank-Sum test along with multiple imputation to adjust for missing data||||||<0.05
72509506|NCT02626819|144549886|SUPERIORITY||||||<|0.05|||||||Fisher Exact|||||||<0.05
72509507|NCT02626819|144549887|SUPERIORITY||||||<|0.05|||||||Fisher Exact|||||||<0.05
72400381|NCT03760146|144308713|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|0.86|||||TWO_SIDED|95.0|0.77|0.96||||||Serotype 7F: Geometric mean ratio (20vPnC/Saline vs 13vPnC/PPSV23) and the 2-sided 95% CI||0.96|0.77|
72400382|NCT03760146|144308713|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|0.93|||||TWO_SIDED|95.0|0.82|1.05||||||Serotype 9V: Geometric mean ratio (20vPnC/Saline vs 13vPnC/PPSV23) and the 2-sided 95% CI||1.05|0.82|
72400383|NCT03760146|144308713|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|1.0|||||TWO_SIDED|95.0|0.89|1.13||||||Serotype 14: Geometric mean ratio (20vPnC/Saline vs 13vPnC/PPSV23) and the 2-sided 95% CI||1.13|0.89|
72400384|NCT03760146|144308713|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|0.85|||||TWO_SIDED|95.0|0.74|0.97||||||Serotype 18C: Geometric mean ratio (20vPnC/Saline vs 13vPnC/PPSV23) and the 2-sided 95% CI||0.97|0.74|
72400385|NCT03760146|144308713|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|0.8|||||TWO_SIDED|95.0|0.71|0.9||||||Serotype 19A: Geometric mean ratio (20vPnC/Saline vs 13vPnC/PPSV23) and the 2-sided 95% CI||0.90|0.71|
72400386|NCT03760146|144308713|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|0.8|||||TWO_SIDED|95.0|0.7|0.91||||||Serotype 19F: Geometric mean ratio (20vPnC/Saline vs 13vPnC/PPSV23) and the 2-sided 95% CI||0.91|0.70|
72400387|NCT03760146|144308713|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|0.83|||||TWO_SIDED|95.0|0.7|0.97||||||Serotype 23F: Geometric mean ratio (20vPnC/Saline vs 13vPnC/PPSV23) and the 2-sided 95% CI||0.97|0.70|
72509508|NCT02626819|144549888|SUPERIORITY||||||<|0.05|||||||Fisher Exact|||||||<0.05
72509509|NCT02626819|144549889|SUPERIORITY||||||<|0.05|||||||Fisher Exact|||||||<0.05
72509510|NCT02626819|144549890|SUPERIORITY||||||<|0.05|||||||Fisher Exact|||||||<0.05
72400388|NCT03760146|144308714|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|0.55|||||TWO_SIDED|95.0|0.49|0.62||||||Serotype 8: Geometric mean ratio (20vPnC/Saline vs 13vPnC/PPSV23) and the 2-sided 95% CI||0.62|0.49|
72400389|NCT03760146|144308714|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|1.86|||||TWO_SIDED|95.0|1.63|2.12||||||Serotype 10A: Geometric mean ratio (20vPnC/Saline vs 13vPnC/PPSV23) and the 2-sided 95% CI||2.12|1.63|
72400390|NCT03760146|144308714|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|1.75|||||TWO_SIDED|95.0|1.52|2.01||||||Serotype 11A: Geometric mean ratio (20vPnC/Saline vs 13vPnC/PPSV23) and the 2-sided 95% CI||2.01|1.52|
72400391|NCT03760146|144308714|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|1.48|||||TWO_SIDED|95.0|1.27|1.72||||||Serotype 12F: Geometric mean ratio (20vPnC/Saline vs 13vPnC/PPSV23) and the 2-sided 95% CI||1.72|1.27|
72509511|NCT00502307|144549896|OTHER||Exact binomial distribution|24.6|||||TWO_SIDED|95.0|19.6|30.2||||||||30.2|19.6|
72509512|NCT00502307|144549896|OTHER||Exact binomial distribution|18.0|||||TWO_SIDED|95.0|13.6|23.1||||||||23.1|13.6|
72509513|NCT00502307|144549897|OTHER|||||||0.001|||||||Cochran-Mantel-Haenszel|||||||0.001
72509514|NCT00502307|144549897|OTHER|||||||0.001|||||||Cochran-Mantel-Haenszel|||||||0.001
72509515|NCT00502307|144549898|OTHER|||||||0.005|||||||Log Rank|||||||0.005
72509516|NCT00502307|144549898|OTHER|||||||0.129|||||||Log Rank|||||||0.129
72509517|NCT00502307|144549899|OTHER|||||||0.003|||||||Log Rank|||||||0.003
72509518|NCT00502307|144549899|OTHER|||||||0.089|||||||Log Rank|||||||0.089
72509519|NCT00051558|144549920|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||All comparisons were conducted using a 2-sided significance level of 0.05.|ANOVA|ANOVA Model: Change in BMD=treatment+region+prior bisphosponate use+gender. Least Squares Means from treatment.||This is a last observation carried forward analysis that included all patients with a baseline and at least one postbaseline lumbar spine bone mineral density (BMD) measurement.||||<0.001
72509520|NCT00051558|144549921|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||All comparisons were conducted using a 2-sided significance level of 0.05.|ANOVA|ANOVA Model: Change in BMD=treatment+region+prior bisphosponate use. Least Squares Means from treatment.||This is a last observation carried forward analysis that included all patients with a baseline and at least one postbaseline lumbar spine bone mineral density (BMD) measurement.||||<0.001
72509521|NCT00051558|144549922|SUPERIORITY_OR_OTHER|||||||0.058||95.0||||P-value for Month 3|Mixed Models Analysis|Least Squares Means obtained from the treatment\*visit interaction term from the above mixed model repeated measures model.||Mixed Model Repeated Measures: Change in BMD=treatment+region+prior bisphosphonate use+gender+baseline BMD+visit+treatment\*visit.||||0.058
72509522|NCT00051558|144549922|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for 6 months|Mixed Models Analysis|Least Squares Means obtained from the treatment\*visit interaction term from the above mixed model repeated measures model.||Mixed Model Repeated Measures: Change in BMD=treatment+region+prior bisphosphonate use+gender+baseline BMD+visit+treatment\*visit.||||<0.001
72509523|NCT00051558|144549922|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for 12 months|Mixed Models Analysis|Least Squares Means obtained from the treatment\*visit interaction term from the above mixed model repeated measures model.||Mixed Model Repeated Measures: Change in BMD=treatment+region+prior bisphosphonate use+gender+baseline BMD+visit+treatment\*visit.||||<0.001
72509524|NCT00051558|144549922|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for 18 months|Mixed Models Analysis|Least Squares Means obtained from the treatment\*visit interaction term from the above mixed model repeated measures model.||Mixed Model Repeated Measures: Change in BMD=treatment+region+prior bisphosphonate use+gender+baseline BMD+visit+treatment\*visit.||||<0.001
72400392|NCT03760146|144308714|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|3.12|||||TWO_SIDED|95.0|2.62|3.71||||||Serotype 15B: Geometric mean ratio (20vPnC/Saline vs 13vPnC/PPSV23) and the 2-sided 95% CI||3.71|2.62|
72509525|NCT00051558|144549922|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for 24 months|Mixed Models Analysis|Least Squares Means obtained from the treatment\*visit interaction term from the above mixed model repeated measures model.||Mixed Model Repeated Measures: Change in BMD=treatment+region+prior bisphosphonate use+gender+baseline BMD+visit+treatment\*visit.||||<0.001
72566582|NCT02985879|144663397|SUPERIORITY|The analysis utilized a likelihood-based, mixed-effects model, repeated measures (MMRM) analysis of the change from baseline for each postbaseline value and compared each ABBV-8E12 dose group with the placebo group. The model, which used all observed data, included fixed, categorical effects for treatment, site, visit, baseline score-by-visit interaction and treatment-by-visit interaction, with continuous fixed covariates for the corresponding baseline score.|LS Mean Difference|-26.4|STANDARD_ERROR_OF_MEAN|53.86||0.625|TWO_SIDED|95.0|-132.76|79.94|||Mixed-effects model, repeated measures||ABBV-8E12 2000 mg - Placebo|ABBV-8E12 2000 mg vs Placebo||79.94|-132.76|0.625
72400393|NCT03760146|144308714|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|1.99|||||TWO_SIDED|95.0|1.7|2.32||||||Serotype 22F: Geometric mean ratio (20vPnC/Saline vs 13vPnC/PPSV23) and the 2-sided 95% CI||2.32|1.70|
72566583|NCT02985879|144663397|SUPERIORITY|The analysis utilized a likelihood-based, mixed-effects model, repeated measures (MMRM) analysis of the change from baseline for each postbaseline value and compared each ABBV-8E12 dose group with the placebo group. The model, which used all observed data, included fixed, categorical effects for treatment, site, visit, baseline score-by-visit interaction and treatment-by-visit interaction, with continuous fixed covariates for the corresponding baseline score.|LS Mean Difference|33.2|STANDARD_ERROR_OF_MEAN|55.47|=|0.55|TWO_SIDED|95.0|-76.34|142.71|||Mixed-effects model, repeated measures||ABBV-8E12 4000 mg - Placebo|ABBV-8E12 4000 mg vs Placebo||142.71|-76.34|=0.550
72400394|NCT03760146|144308714|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|1.38|||||TWO_SIDED|95.0|1.21|1.57||||||Serotype 33F: Geometric mean ratio (20vPnC/Saline vs 13vPnC/PPSV23) and the 2-sided 95% CI||1.57|1.21|
72400395|NCT03760146|144308715|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|1.03|||||TWO_SIDED|95.0|0.84|1.26||||||Serotype 1: GMR (20vPnC Cohort 2 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI||1.26|0.84|
72400396|NCT03760146|144308715|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|1.06|||||TWO_SIDED|95.0|0.92|1.22||||||Serotype 3: GMR (20vPnC Cohort 2 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI||1.22|0.92|
72400397|NCT03760146|144308715|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|1.1|||||TWO_SIDED|95.0|0.87|1.38||||||Serotype 4: GMR (20vPnC Cohort 2 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI||1.38|0.87|
72400398|NCT03760146|144308715|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|0.88|||||TWO_SIDED|95.0|0.72|1.07||||||Serotype 5: GMR (20vPnC Cohort 2 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI||1.07|0.72|
72400399|NCT03760146|144308715|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|1.21|||||TWO_SIDED|95.0|0.95|1.53||||||Serotype 6A: GMR (20vPnC Cohort 2 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI||1.53|0.95|
72400400|NCT03760146|144308715|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|1.25|||||TWO_SIDED|95.0|1.0|1.56||||||Serotype 6B: GMR (20vPnC Cohort 2 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI||1.56|1.00|
72400401|NCT03760146|144308715|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|0.89|||||TWO_SIDED|95.0|0.74|1.07||||||Serotype 7F: GMR (20vPnC Cohort 2 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI||1.07|0.74|
72400402|NCT03760146|144308715|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|1.02|||||TWO_SIDED|95.0|0.83|1.26||||||Serotype 9V: GMR (20vPnC Cohort 2 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI||1.26|0.83|
72400403|NCT03760146|144308715|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|1.25|||||TWO_SIDED|95.0|1.01|1.54||||||Serotype 14: GMR (20vPnC Cohort 2 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI||1.54|1.01|
72400404|NCT03760146|144308715|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|1.33|||||TWO_SIDED|95.0|1.06|1.68||||||Serotype 18C: GMR (20vPnC Cohort 2 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI||1.68|1.06|
72400405|NCT03760146|144308715|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|1.03|||||TWO_SIDED|95.0|0.85|1.25||||||Serotype 19A: GMR (20vPnC Cohort 2 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI||1.25|0.85|
72400406|NCT03760146|144308715|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|0.99|||||TWO_SIDED|95.0|0.8|1.22||||||Serotype 19F: GMR (20vPnC Cohort 2 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI||1.22|0.80|
72509526|NCT00051558|144549922|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for 36 months|Mixed Models Analysis|Least Squares Means obtained from the treatment\*visit interaction term from the above mixed model repeated measures model.||Mixed Model Repeated Measures: Change in BMD=treatment+region+prior bisphosphonate use+gender+baseline BMD+visit+treatment\*visit.||||<0.001
72400407|NCT03760146|144308715|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|1.68|||||TWO_SIDED|95.0|1.27|2.22||||||Serotype 23F: GMR (20vPnC Cohort 2 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI||2.22|1.27|
72509527|NCT00051558|144549923|SUPERIORITY_OR_OTHER|||||||0.12||95.0||||P-value for 3 Months|Mixed Models Analysis|Least Squares Means obtained from the treatment\*visit interaction term from the above mixed model repeated measures model.||Mixed Model Repeated Measures: Change in BMD=treatment+region+prior bisphosphonate use+gender+baseline BMD+visit+treatment\*visit.||||0.120
72509528|NCT00051558|144549923|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for 6 months|Mixed Models Analysis|Least Squares Means obtained from the treatment\*visit interaction term from the above mixed model repeated measures model.||Mixed Model Repeated Measures: Change in BMD=treatment+region+prior bisphosphonate use+gender+baseline BMD+visit+treatment\*visit.||||<0.001
72509529|NCT00051558|144549923|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for 12 months|Mixed Models Analysis|Least Squares Means obtained from the treatment\*visit interaction term from the above mixed model repeated measures model.||Mixed Model Repeated Measures: Change in BMD=treatment+region+prior bisphosphonate use+gender+baseline BMD+visit+treatment\*visit.||||<0.001
72509530|NCT00051558|144549923|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for 18 months|Mixed Models Analysis|Least Squares Means obtained from the treatment\*visit interaction term from the above mixed model repeated measures model.||Mixed Model Repeated Measures: Change in BMD=treatment+region+prior bisphosphonate use+gender+baseline BMD+visit+treatment\*visit.||||<0.001
72509531|NCT00051558|144549924|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value for 36 month endpoint|ANOVA|ANOVA Model: Change in BMD=treatment+region+prior bisphosponate use+gender. Least Squares Means from treatment.||This is a last observation carried forward analysis that included all patients with a baseline and at least one postbaseline lumbar spine bone mineral density (BMD) measurement.||||<0.001
72509532|NCT00051558|144549924|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value for 36 months|Mixed Models Analysis|Least Squares Means obtained from the treatment\*visit interaction term from the above mixed model repeated measures model.||Mixed Model Repeated Measures: Change in BMD=treatment+region+prior bisphosphonate use+gender+baseline BMD+visit+treatment\*visit.||||<0.001
72576858|NCT00261443|144680664|SUPERIORITY_OR_OTHER_LEGACY||Difference|0.1||||0.488|TWO_SIDED|95.0|-0.19|0.4||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 4 Comparison||0.40|-0.19|0.488
72400408|NCT03760146|144308715|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|0.97|||||TWO_SIDED|95.0|0.78|1.2||||||Serotype 8: GMR (20vPnC Cohort 2 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI||1.20|0.78|
72400409|NCT03760146|144308715|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|1.03|||||TWO_SIDED|95.0|0.84|1.28||||||Serotype 10A: GMR (20vPnC Cohort 2 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI||1.28|0.84|
72400410|NCT03760146|144308715|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|1.22|||||TWO_SIDED|95.0|0.96|1.56||||||Serotype 11A: GMR (20vPnC Cohort 2 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI||1.56|0.96|
72509533|NCT00051558|144549924|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for 24 months|Mixed Models Analysis|Least Squares Means obtained from the treatment\*visit interaction term from the above mixed model repeated measures model.||Mixed Model Repeated Measures: Change in BMD=treatment+region+prior bisphosphonate use+gender+baseline BMD+visit+treatment\*visit.||||<0.001
72509534|NCT00051558|144549925|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for 36-month endpoint|ANOVA|ANOVA Model: Change in BMD=treatment+region+prior bisphosponate use+gender. Least Squares Means from treatment.||This is a last observation carried forward analysis that included all patients with a baseline and at least one postbaseline femoral neck bone mineral density (BMD) measurement.||||<0.001
72509535|NCT00051558|144549925|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for 36 months|Mixed Models Analysis|Least Squares Means obtained from the treatment\*visit interaction term from the above mixed model repeated measures model.||Mixed Model Repeated Measures: Change in BMD=treatment+region+prior bisphosphonate use+gender+baseline BMD+visit+treatment\*visit.||||<0.001
72509536|NCT00051558|144549925|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||P-value for 24 months|Mixed Models Analysis|Least Squares Means obtained from the treatment\*visit interaction term from the above mixed model repeated measures model.||Mixed Model Repeated Measures: Change in BMD=treatment+region+prior bisphosphonate use+gender+baseline BMD+visit+treatment\*visit.||||0.002
72509537|NCT00051558|144549925|SUPERIORITY_OR_OTHER|||||||0.011||95.0||||P-value for 18 month endpoint|ANOVA|ANOVA Model: Change in BMD=treatment+region+prior bisphosponate use+gender. Least Squares Means from treatment.||This is a last observation carried forward analysis that included all patients with a baseline and at least one postbaseline femoral neck bone mineral density (BMD) measurement.||||0.011
72509538|NCT00051558|144549925|SUPERIORITY_OR_OTHER|||||||0.015||95.0||||P-value for 18 months|Mixed Models Analysis|Least Squares Means obtained from the treatment\*visit interaction term from the above mixed model repeated measures model.||Mixed Model Repeated Measures: Change in BMD=treatment+region+prior bisphosphonate use+gender+baseline BMD+visit+treatment\*visit.||||0.015
72509539|NCT00051558|144549926|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for 36 month endpoint|ANOVA|ANOVA Model: Change in BMD=treatment+region+prior bisphosponate use+gender. Least Squares Means from treatment.||This is a last observation carried forward analysis that included all patients with a baseline and at least one postbaseline total hip bone mineral density (BMD) measurement.||||<0.001
72509540|NCT00051558|144549926|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for 36 months|Mixed Models Analysis|Least Squares Means obtained from the treatment\*visit interaction term from the above mixed model repeated measures model.||Mixed Model Repeated Measures: Change in BMD=treatment+region+prior bisphosphonate use+gender+baseline BMD+visit+treatment\*visit.||||<0.001
72400411|NCT03760146|144308715|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|1.11|||||TWO_SIDED|95.0|0.88|1.39||||||Serotype 12F: GMR (20vPnC Cohort 2 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI||1.39|0.88|
72400412|NCT03760146|144308715|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|1.17|||||TWO_SIDED|95.0|0.88|1.56||||||Serotype 15B: GMR (20vPnC Cohort 2 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI||1.56|0.88|
72400413|NCT03760146|144308715|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|0.9|||||TWO_SIDED|95.0|0.69|1.17||||||Serotype 22F: GMR (20vPnC Cohort 2 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI||1.17|0.69|
72400414|NCT03760146|144308715|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|1.02|||||TWO_SIDED|95.0|0.81|1.3||||||Serotype 33F: GMR (20vPnC Cohort 2 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI||1.30|0.81|
72400415|NCT03760146|144308716|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|1.23|||||TWO_SIDED|95.0|1.01|1.5||||||Serotype 1: GMR (20vPnC Cohort 3 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI||1.50|1.01|
72400416|NCT03760146|144308716|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|1.0|||||TWO_SIDED|95.0|0.87|1.16||||||Serotype 3: GMR (20vPnC Cohort 3 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI||1.16|0.87|
72400417|NCT03760146|144308716|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|3.31|||||TWO_SIDED|95.0|2.65|4.13||||||Serotype 4: GMR (20vPnC Cohort 3 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI||4.13|2.65|
72400418|NCT03760146|144308716|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|1.11|||||TWO_SIDED|95.0|0.91|1.36||||||Serotype 5: GMR (20vPnC Cohort 3 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI||1.36|0.91|
72400419|NCT03760146|144308716|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|3.84|||||TWO_SIDED|95.0|3.06|4.83||||||Serotype 6A: GMR (20vPnC Cohort 3 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI||4.83|3.06|
72509541|NCT00051558|144549926|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for 24 months|Mixed Models Analysis|Least Squares Means obtained from the treatment\*visit interaction term from the above mixed model repeated measures model.||Mixed Model Repeated Measures: Change in BMD=treatment+region+prior bisphosphonate use+gender+baseline BMD+visit+treatment\*visit.||||<0.001
72509542|NCT00051558|144549926|SUPERIORITY_OR_OTHER|||||||0.006||95.0||||P-value for 18 month endpoint|ANOVA|ANOVA Model: Change in BMD=treatment+region+prior bisphosponate use+gender. Least Squares Means from treatment.||This is a last observation carried forward analysis that included all patients with a baseline and at least one postbaseline total hip bone mineral density (BMD) measurement.||||0.006
72576859|NCT00261443|144680664|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.15||||0.349|TWO_SIDED|95.0|-0.46|0.16||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 8 Comparison||0.16|-0.46|0.349
72400420|NCT03760146|144308716|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|3.41|||||TWO_SIDED|95.0|2.73|4.26||||||Serotype 6B: GMR (20vPnC Cohort 3 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI||4.26|2.73|
72400421|NCT03760146|144308716|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|1.58|||||TWO_SIDED|95.0|1.3|1.91||||||Serotype 7F: GMR (20vPnC Cohort 3 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI||1.91|1.30|
72400422|NCT03760146|144308716|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|3.5|||||TWO_SIDED|95.0|2.83|4.33||||||Serotype 9V: GMR (20vPnC Cohort 3 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI||4.33|2.83|
72400423|NCT03760146|144308716|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|2.39|||||TWO_SIDED|95.0|1.93|2.96||||||Serotype 14: GMR (20vPnC Cohort 3 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI||2.96|1.93|
72400424|NCT03760146|144308716|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|3.2|||||TWO_SIDED|95.0|2.53|4.04||||||Serotype 18C: GMR (20vPnC Cohort 3 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI||4.04|2.53|
72400425|NCT03760146|144308716|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|2.31|||||TWO_SIDED|95.0|1.91|2.81||||||Serotype 19A: GMR (20vPnC Cohort 3 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI||2.81|1.91|
72509543|NCT00051558|144549926|SUPERIORITY_OR_OTHER|||||||0.009||95.0||||P-value for 18 months|Mixed Models Analysis|Least Squares Means obtained from the treatment\*visit interaction term from the above mixed model repeated measures model.||Mixed Model Repeated Measures: Change in BMD=treatment+region+prior bisphosphonate use+gender+baseline BMD+visit+treatment\*visit.||||0.009
72509544|NCT00051558|144549927|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for 12 months|Mixed Models Analysis|Least Squares Means obtained from the treatment\*visit interaction term from the above mixed model repeated measures model.||Mixed Model Repeated Measures: Change in BMD=treatment+region+prior bisphosphonate use+gender+baseline BMD+visit+treatment\*visit.||||<0.001
72509545|NCT00051558|144549927|SUPERIORITY_OR_OTHER|||||||0.015||95.0||||P-value for 18 months|Mixed Models Analysis|Least Squares Means obtained from the treatment\*visit interaction term from the above mixed model repeated measures model.||Mixed Model Repeated Measures: Change in BMD=treatment+region+prior bisphosphonate use+gender+baseline BMD+visit+treatment\*visit.||||0.015
72509546|NCT00051558|144549927|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||P-value for 24 months|Mixed Models Analysis|Least Squares Means obtained from the treatment\*visit interaction term from the above mixed model repeated measures model.||Mixed Model Repeated Measures: Change in BMD=treatment+region+prior bisphosphonate use+gender+baseline BMD+visit+treatment\*visit.||||0.002
72400426|NCT03760146|144308716|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|2.17|||||TWO_SIDED|95.0|1.76|2.68||||||Serotype 19F: GMR (20vPnC Cohort 3 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI||2.68|1.76|
72400427|NCT03760146|144308716|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|4.8|||||TWO_SIDED|95.0|3.65|6.32||||||Serotype 23F: GMR (20vPnC Cohort 3 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI||6.32|3.65|
72400428|NCT03760146|144308716|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|1.71|||||TWO_SIDED|95.0|1.38|2.12||||||Serotype 8: GMR (20vPnC Cohort 3 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI||2.12|1.38|
72400429|NCT03760146|144308716|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|1.62|||||TWO_SIDED|95.0|1.31|2.0||||||Serotype 10A: GMR (20vPnC Cohort 3 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI||2.00|1.31|
72400430|NCT03760146|144308716|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|1.32|||||TWO_SIDED|95.0|1.04|1.68||||||Serotype 11A: GMR (20vPnC Cohort 3 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI||1.68|1.04|
72400431|NCT03760146|144308716|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|1.91|||||TWO_SIDED|95.0|1.51|2.41||||||Serotype 12F: GMR (20vPnC Cohort 3 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI||2.41|1.51|
72400432|NCT03760146|144308716|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|1.52|||||TWO_SIDED|95.0|1.13|2.05||||||Serotype 15B: GMR (20vPnC Cohort 3 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI||2.05|1.13|
72400433|NCT03760146|144308716|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|1.69|||||TWO_SIDED|95.0|1.3|2.2||||||Serotype 22F: GMR (20vPnC Cohort 3 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI||2.20|1.30|
72400434|NCT03760146|144308716|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|1.4|||||TWO_SIDED|95.0|1.1|1.79||||||Serotype 33F: GMR (20vPnC Cohort 3 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI||1.79|1.10|
72400435|NCT01559012|144308727|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.2|STANDARD_DEVIATION|2.7||0.001|TWO_SIDED|95.0|1.05|3.32||A sample size modeling (MGH Mallinckrodt General Clinical Research Center) showed that a total of 12 patients were needed in order to detect a difference of 2 points of PUQE score between the two groups at P \< 0.01 and a beta \> 0.90.|Wilcoxon (Mann-Whitney)|Statistical signiﬁcance was assessed by the use of Mann-Whitney U test. P \< 0.05 was deﬁned as statistically signiﬁcant||This is an analysis between groups of intervention clonidine versus placebo. Statistical signiﬁcance was assessed by the use of Mann-Whitney U test P \< 0.05 was deﬁned as statistically signiﬁcant . Data are presented as mean + SD.||3.32|1.05|0.001
72479581|NCT00706433|144485197|SUPERIORITY_OR_OTHER|||||||0.0395||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.0395
72400436|NCT01559012|144308727|NON_INFERIORITY_OR_EQUIVALENCE|A sample size modeling (MGH Mallinckrodt General Clinical Research Center) showed that a total of 12 patients were needed in order to detect a difference of 2 points of PUQE score between the two groups at P \< 0.01|within patient variation|1.83|||<|0.02|TWO_SIDED|95.0|0.43|3.24|||Wilcoxon (Mann-Whitney)|||This is a within patient variation between clonidine and placebo. Statistical signiﬁcance was assessed by the use of Mann-Whitney U test P \< 0.05 was deﬁned as statistically signiﬁcant . Data are presented as mean +/- Standard Deviation (SD).||3.24|0.43|<0.02
72479582|NCT00706433|144485197|SUPERIORITY_OR_OTHER|||||||0.7426||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.7426
72509547|NCT00051558|144549927|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for 36 months|Mixed Models Analysis|Least Squares Means obtained from the treatment\*visit interaction term from the above mixed model repeated measures model.||Mixed Model Repeated Measures: Change in BMD=treatment+region+prior bisphosphonate use+gender+baseline BMD+visit+treatment\*visit.||||<0.001
72509548|NCT00051558|144549928|SUPERIORITY_OR_OTHER|||||||0.011||95.0||||P-value for 12 months|Mixed Models Analysis|Least Squares Means obtained from the treatment\*visit interaction term from the above mixed model repeated measures model.||Mixed Model Repeated Measures: Change in BMD=treatment+region+prior bisphosphonate use+gender+baseline BMD+visit+treatment\*visit.||||0.011
72509549|NCT00051558|144549928|SUPERIORITY_OR_OTHER|||||||0.009||95.0||||P-value for 18 months|Mixed Models Analysis|Least Squares Means obtained from the treatment\*visit interaction term from the above mixed model repeated measures model.||Mixed Model Repeated Measures: Change in BMD=treatment+region+prior bisphosphonate use+gender+baseline BMD+visit+treatment\*visit.||||0.009
72400437|NCT01559012|144308728|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.0||||0.009|TWO_SIDED|95.0|1.78|11.5|||Wilcoxon (Mann-Whitney)|||Analysis within groups clonidine versus placebo. Statistical signiﬁcance was assessed by the use of Mann-Whitney U test P \< 0.05 was deﬁned as statistically signiﬁcant . Data are presented as mean + SD. .||11.5|1.78|0.009
72400438|NCT01559012|144308728|NON_INFERIORITY_OR_EQUIVALENCE|A sample size modeling for crossover studies (MGH Mallinckrodt General Clinical Research Center) showed that a total of 12 patients were needed in order to detect a difference of 2 points of PUQE score between the two groups at P \< 0.01|within patient variation|7.5|||<|0.01|TWO_SIDED|95.0|2.17|12.83|||Wilcoxon (Mann-Whitney)|||Analysis within-patient. Statistical signiﬁcance was assessed by the use of Mann-Whitney U test P \< 0.05 was deﬁned as statistically signiﬁcant . Data are presented as mean + SD.||12.83|2.17|<0.01
72400439|NCT01559012|144308729|SUPERIORITY_OR_OTHER||difference of percentage of positivity|0.3||||0|TWO_SIDED|95.0|0.04|0.47|||Wilcoxon (Mann-Whitney)|||"All patients were treated with TD clonidine for 5 days and switched to placebo for 5 days, or the other way round~Allocation order randomized"||0.47|0.04|0.000
72400440|NCT01559012|144308730|SUPERIORITY_OR_OTHER||mean values|0.8||||0.013|TWO_SIDED|95.0|0.13|1.57|||Wilcoxon (Mann-Whitney)|||Statistical signiﬁcance was assessed by the use of Mann-Whitney U test P \< 0.05 was deﬁned as statistically signiﬁcant . Data are presented as mean + SD. .||1.57|0.13|0.013
72400441|NCT01559012|144308731|SUPERIORITY_OR_OTHER||days off-therapy %|29.0||||0.051|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||Statistical signiﬁcance was assessed by the use of Mann-Whitney U test P \< 0.05 was deﬁned as statistically signiﬁcant . Data are presented as mean + SD. .||||0.051
72400442|NCT01559012|144308732|SUPERIORITY_OR_OTHER||proportion|0.0||||0.0089|TWO_SIDED|95.0|||||Fisher Exact|||||||0.0089
72400443|NCT01559012|144308735|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.0||||0.01|TWO_SIDED|95.0|0.9|10.9|||Wilcoxon (Mann-Whitney)|||||10.9|0.9|0.01
72400444|NCT01559012|144308736|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.0||||0.055|TWO_SIDED|95.0|0.3|6.3|||Wilcoxon (Mann-Whitney)|||||6.3|0.3|0.055
72400445|NCT00946712|144308737|OTHER||Hazard Ratio (HR)|0.93||||0.22|TWO_SIDED|95.0|0.83|1.04|||Log Rank|A stratified log rank test was used.||||1.04|0.83|0.22
72479583|NCT00706433|144485197|SUPERIORITY_OR_OTHER|||||||0.0029||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.0029
72479584|NCT00706433|144485197|SUPERIORITY_OR_OTHER|||||||0.2142||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.2142
72479585|NCT00706433|144485197|SUPERIORITY_OR_OTHER|||||||0.0781||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.0781
72479586|NCT00706433|144485198|SUPERIORITY_OR_OTHER|||||||0.9886||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.9886
72509550|NCT00051558|144549928|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for 24 months|Mixed Models Analysis|Least Squares Means obtained from the treatment\*visit interaction term from the above mixed model repeated measures model.||Mixed Model Repeated Measures: Change in BMD=treatment+region+prior bisphosphonate use+gender+baseline BMD+visit+treatment\*visit.||||<0.001
72509551|NCT00051558|144549928|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for 36 months|Mixed Models Analysis|Least Squares Means obtained from the treatment\*visit interaction term from the above mixed model repeated measures model.||Mixed Model Repeated Measures: Change in BMD=treatment+region+prior bisphosphonate use+gender+baseline BMD+visit+treatment\*visit.||||<0.001
72400446|NCT00946712|144308738|OTHER||Hazard Ratio (HR)|0.92||||0.4|TWO_SIDED|95.0|0.75|1.12|||Log Rank|A stratified log rank test was used.||||1.12|0.75|0.40
72400447|NCT00946712|144308739|OTHER||Hazard Ratio (HR)|0.81||||0.054|TWO_SIDED|95.0|0.66|1.0|||Log Rank|A stratified log rank test was used.||||1.00|0.66|0.054
72400448|NCT00946712|144308741|OTHER||Hazard Ratio (HR)|0.99||||0.83|TWO_SIDED|95.0|0.88|1.1|||Log Rank|A stratified log rank test was used.||||1.10|0.88|0.83
72400449|NCT00946712|144308743|OTHER|||||||0.48|||||||Cochran-Mantel-Haenszel|A stratified Cochran-Mantel-Haenszel test was conducted.||||||0.48
72400450|NCT00946712|144308744|OTHER|||||||0.06|||||||Cochran-Mantel-Haenszel|A stratified Cochran-Mantel-Haenszel test was conducted.||||||0.060
72479587|NCT00706433|144485199|SUPERIORITY_OR_OTHER|||||||0.6907||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.6907
72479588|NCT00706433|144485200|SUPERIORITY_OR_OTHER|||||||0.0047||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.0047
72479589|NCT00706433|144485200|SUPERIORITY_OR_OTHER|||||||0.6116||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.6116
72509552|NCT00051558|144549929|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Month 1|Wilcoxon (Mann-Whitney)|Wilcoxon Rank Sum Test using the aligned ranks for scores.||||||<0.001
72509553|NCT00051558|144549929|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Month 6|Wilcoxon (Mann-Whitney)|Wilcoxon Rank Sum Test using the aligned ranks for scores.||||||<0.001
72509554|NCT00051558|144549929|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Month 18|Wilcoxon (Mann-Whitney)|Wilcoxon Rank Sum Test using the aligned ranks for scores.||||||<0.001
72509555|NCT00051558|144549929|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Month 36|Wilcoxon (Mann-Whitney)|Wilcoxon Rank Sum Test using the aligned ranks for scores.||||||<0.001
72509556|NCT00051558|144549930|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Month 1|Wilcoxon (Mann-Whitney)|Wilcoxon Rank Sum Test using the aligned ranks for scores.||||||<0.001
72509557|NCT00051558|144549930|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Month 6|Wilcoxon (Mann-Whitney)|Wilcoxon Rank Sum Test using the aligned ranks for scores.||||||<0.001
72479590|NCT00706433|144485200|SUPERIORITY_OR_OTHER|||||||0.0209||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.0209
72479591|NCT00706433|144485200|SUPERIORITY_OR_OTHER|||||||0.0513||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.0513
72509558|NCT00051558|144549930|SUPERIORITY_OR_OTHER|||||||0.004||95.0||||P-value for Month 18|Wilcoxon (Mann-Whitney)|Wilcoxon Rank Sum Test using the aligned ranks for scores.||||||0.004
72509559|NCT00051558|144549930|SUPERIORITY_OR_OTHER|||||||0.013||95.0||||P-value for Month 36|Wilcoxon (Mann-Whitney)|Wilcoxon Rank Sum Test using the aligned ranks for scores.||||||0.013
72509560|NCT00051558|144549931|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Month 1|Wilcoxon (Mann-Whitney)|Wilcoxon Rank Sum Test using the aligned ranks for scores.||||||<0.001
72566584|NCT02985879|144663398|SUPERIORITY|The analysis utilized a likelihood-based, mixed-effects model, repeated measures (MMRM) analysis of the change from baseline for each postbaseline value and compared each ABBV-8E12 dose group with the placebo group. The model, which used all observed data, included fixed, categorical effects for treatment, site, visit, baseline score-by-visit interaction and treatment-by-visit interaction, with continuous fixed covariates for the corresponding baseline score.|LS Mean Difference|1739.1|STANDARD_ERROR_OF_MEAN|2502.95|=|0.488|TWO_SIDED|95.0|-3201.75|6680.02|||Mixed-effects model, repeated measures||ABBV-8E12 2000 mg - Placebo|ABBV-8E12 2000 mg vs Placebo||6680.02|-3201.75|=0.488
72566585|NCT02985879|144663398|SUPERIORITY|The analysis utilized a likelihood-based, mixed-effects model, repeated measures (MMRM) analysis of the change from baseline for each postbaseline value and compared each ABBV-8E12 dose group with the placebo group. The model, which used all observed data, included fixed, categorical effects for treatment, site, visit, baseline score-by-visit interaction and treatment-by-visit interaction, with continuous fixed covariates for the corresponding baseline score.|LS Mean Difference|3684.9|STANDARD_ERROR_OF_MEAN|2487.32|=|0.14|TWO_SIDED|95.0|-1225.46|8595.29|||Mixed-effects model, repeated measures||ABBV-8E12 4000 mg - Placebo|ABBV-8E12 4000 mg vs Placebo||8595.29|-1225.46|=0.140
72400451|NCT01464346|144308774|SUPERIORITY_OR_OTHER||Intercept from ANCOVA as agreement rate|88.01|STANDARD_ERROR_OF_MEAN|1.2|<|0.05|TWO_SIDED|95.0|85.69|90.33|||ANCOVA|Mixed effects model was used, with day of sensor wear(1,3 or 6) as covariate. Day was centered to 0 to permit interpretation of the model intercept||||90.33|85.69|<0.05
72479592|NCT00706433|144485200|SUPERIORITY_OR_OTHER|||||||0.0019||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.0019
72566586|NCT02985879|144663399|SUPERIORITY|The analysis utilized a likelihood-based, mixed-effects model, repeated measures (MMRM) analysis of the change from baseline for each postbaseline value and compared each ABBV-8E12 dose group with the placebo group. The model, which used all observed data, included fixed, categorical effects for treatment, site, visit, baseline score-by-visit interaction and treatment-by-visit interaction, with continuous fixed covariates for the corresponding baseline score.|LS Mean Difference|207.9|STANDARD_ERROR_OF_MEAN|592.68|=|0.726|TWO_SIDED|95.0|-962.98|1378.88|||Mixed-effects model, repeated measures||ABBV-8E12 2000 mg - Placebo|ABBV-8E12 2000 mg vs Placebo||1378.88|-962.98|=0.726
72479593|NCT00706433|144485200|SUPERIORITY_OR_OTHER|||||||0.0089||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.0089
72479594|NCT00706433|144485200|SUPERIORITY_OR_OTHER|||||||0.526||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.5260
72509561|NCT00051558|144549931|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Month 6|Wilcoxon (Mann-Whitney)|Wilcoxon Rank Sum Test using the aligned ranks for scores.||||||<0.001
72509562|NCT00051558|144549931|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Month 18|Wilcoxon (Mann-Whitney)|Wilcoxon Rank Sum Test using the aligned ranks for scores.||||||<0.001
72509563|NCT00051558|144549931|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Month 36|Wilcoxon (Mann-Whitney)|Wilcoxon Rank Sum Test using the aligned ranks for scores.||||||<0.001
72509564|NCT00051558|144549932|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Month 1|Wilcoxon (Mann-Whitney)|Wilcoxon Rank Sum Test using the aligned ranks for scores.||||||<0.001
72509565|NCT00051558|144549932|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Month 6|Wilcoxon (Mann-Whitney)|Wilcoxon Rank Sum Test using the aligned ranks for scores.||||||<0.001
72509566|NCT00051558|144549932|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Month 18|Wilcoxon (Mann-Whitney)|Wilcoxon Rank Sum Test using the aligned ranks for scores.||||||<0.001
72509567|NCT00051558|144549932|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Month 36|Wilcoxon (Mann-Whitney)|Wilcoxon Rank Sum Test using the aligned ranks for scores.||||||<0.001
72509568|NCT00051558|144549933|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Month 1|Wilcoxon (Mann-Whitney)|Wilcoxon Rank Sum Test using the aligned ranks for scores.||||||<0.001
72509569|NCT00051558|144549933|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value at Month 6|Wilcoxon (Mann-Whitney)|Wilcoxon Rank Sum Test using the aligned ranks for scores.||||||<0.001
72509570|NCT00051558|144549933|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value at Month 18|Wilcoxon (Mann-Whitney)|Wilcoxon Rank Sum Test using the aligned ranks for scores.||||||<0.001
72509571|NCT00051558|144549933|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value at Month 36|Wilcoxon (Mann-Whitney)|Wilcoxon Rank Sum Test using the aligned ranks for scores.||||||<0.001
72509572|NCT00051558|144549934|SUPERIORITY_OR_OTHER|||||||0.212||95.0||||p-value for Any Fracture|Cochran-Mantel-Haenszel|||||||0.212
72509573|NCT00051558|144549934|SUPERIORITY_OR_OTHER|||||||0.843||95.0||||p-value for Nonvertebral Fracture|Cochran-Mantel-Haenszel|||||||0.843
72509574|NCT00051558|144549934|SUPERIORITY_OR_OTHER|||||||0.007||95.0||||p-value for Vertebral Fracture|Cochran-Mantel-Haenszel|||||||0.007
72509575|NCT00051558|144549934|SUPERIORITY_OR_OTHER|||||||0.037||95.0||||p-value for Clinical Vertebral Fracture|Cochran-Mantel-Haenszel|||||||0.037
72509576|NCT00051558|144549934|SUPERIORITY_OR_OTHER|||||||0.256||95.0||||p-value for Nonvertebral Fragility Fracture|Cochran-Mantel-Haenszel|||||||0.256
72400452|NCT01464346|144308775|SUPERIORITY_OR_OTHER||Intercept from ANCOVA as agreement rate|90.52|STANDARD_ERROR_OF_MEAN|0.9|<|0.05|TWO_SIDED|95.0|88.77|92.28|||ANCOVA|Mixed effects model was used, with day of sensor wear(1,3 or 6) as covariate. Day was centered to 0 to permit interpretation of the model intercept||||92.28|88.77|< 0.05
72509577|NCT01441440|144549948|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.5||||0.031|TWO_SIDED|95.0|0.14|2.87||Two-sided p-value from an analysis of covariance model including treatment as a factor and baseline as a covariate.|ANCOVA||Adjusted mean difference = Placebo group - Venlafaxine 75 mg/day Fixed group|||2.87|0.14|0.031
72509578|NCT01441440|144549948|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.12||||0.106|TWO_SIDED|95.0|-0.24|2.48||Two-sided p-value from an analysis of covariance model including treatment as a factor and baseline as a covariate.|ANCOVA||Adjusted mean difference = Placebo group - Venlafaxine 75-225 mg/day Flexible group|||2.48|-0.24|0.106
72509579|NCT01441440|144549949|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.88||||0.008|TWO_SIDED|95.0|0.77|5.0||Two-sided p-value from an analysis of covariance model including treatment as a factor and baseline as a covariate.|ANCOVA||Adjusted mean difference = Placebo group - Venlafaxine 75 mg/day Fixed group|||5.00|0.77|0.008
72509580|NCT01441440|144549949|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.64||||0.014|TWO_SIDED|95.0|0.54|4.74||Two-sided p-value from an analysis of covariance model including treatment as a factor and baseline as a covariate.|ANCOVA||Adjusted mean difference = Placebo group - Venlafaxine 75-225 mg/day Flexible group|||4.74|0.54|0.014
72509581|NCT01441440|144549950|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.26||||0.025|TWO_SIDED|95.0|0.03|0.49||Two-sided p-value from an analysis of covariance model including treatment as a factor and baseline as a covariate.|ANCOVA||Adjusted mean difference = Placebo group - Venlafaxine 75 mg/day Fixed group|||0.49|0.03|0.025
72566587|NCT02985879|144663399|SUPERIORITY|The analysis utilized a likelihood-based, mixed-effects model, repeated measures (MMRM) analysis of the change from baseline for each postbaseline value and compared each ABBV-8E12 dose group with the placebo group. The model, which used all observed data, included fixed, categorical effects for treatment, site, visit, baseline score-by-visit interaction and treatment-by-visit interaction, with continuous fixed covariates for the corresponding baseline score.|LS Mean Difference|133.6|STANDARD_ERROR_OF_MEAN|611.91|=|0.828|TWO_SIDED|95.0|-1075.26|1342.4|||Mixed-effects model, repeated measures||ABBV-8E12 4000 mg - Placebo|ABBV-8E12 4000 mg vs Placebo||1342.40|-1075.26|=0.828
72566588|NCT00118378|144663409|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|95.0|||||ANCOVA|||||||< 0.001
72509582|NCT01441440|144549950|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.25||||0.032|TWO_SIDED|95.0|0.02|0.48||Two-sided p-value from an analysis of covariance model including treatment as a factor and baseline as a covariate.|ANCOVA||Adjusted mean difference = Placebo group - Venlafaxine 75-225 mg/day Flexible group|||0.48|0.02|0.032
72509583|NCT01441440|144549951|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.18||||0.004|TWO_SIDED|95.0|0.39|1.97||Two-sided p-value from an analysis of covariance model including treatment as a factor and baseline as a covariate.|ANCOVA||Adjusted mean difference = Placebo group - Venlafaxine 75 mg/day Fixed group|||1.97|0.39|0.004
72509584|NCT01441440|144549951|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.06||||0.008|TWO_SIDED|95.0|0.28|1.85||Two-sided p-value from an analysis of covariance model including treatment as a factor and baseline as a covariate.|ANCOVA||Adjusted mean difference = Placebo group - Venlafaxine 75-225 mg/day Flexible group|||1.85|0.28|0.008
72509585|NCT01441440|144549952|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.5||||0.004|TWO_SIDED|95.0|0.48|2.53||Two-sided p-value from an analysis of covariance model including treatment as a factor and baseline as a covariate.|ANCOVA||Adjusted mean difference = Placebo group - Venlafaxine 75 mg/day Fixed group|||2.53|0.48|0.004
72509586|NCT01441440|144549952|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.77||||0.137|TWO_SIDED|95.0|-0.25|1.79||Two-sided p-value from an analysis of covariance model including treatment as a factor and baseline as a covariate.|ANCOVA||Adjusted mean difference = Placebo group - Venlafaxine 75-225 mg/day Flexible group|||1.79|-0.25|0.137
72509587|NCT01441440|144549953|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.21||||0.073|TWO_SIDED|95.0|-0.02|0.45||Two-sided p-value from an analysis of covariance model including treatment as a factor and baseline score of CGI-S as a covariate.|ANCOVA||Adjusted mean difference = Placebo group - Venlafaxine 75 mg/day Fixed group|||0.45|-0.02|0.073
72509588|NCT01441440|144549953|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.25||||0.034|TWO_SIDED|95.0|0.02|0.48||Two-sided p-value from an analysis of covariance model including treatment as a factor and baseline score of CGI-S as a covariate.|ANCOVA||Adjusted mean difference = Placebo group - Venlafaxine 75-225 mg/day Flexible group|||0.48|0.02|0.034
72509589|NCT00366548|144549961|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lowest limit of the 2-sided 95% CI for the difference between the 2 groups \> -10%.|Difference|-0.8||||||95.0|-5.4|3.7||||||For serotype 4 the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||3.7|-5.4|
72509590|NCT00366548|144549961|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lowest limit of the 2-sided 95% CI for the difference between the 2 groups \> -10%.|Difference|-5.5||||||95.0|-14.2|3.3||||||For serotype 6B the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||3.3|-14.2|
72509591|NCT00366548|144549961|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lowest limit of the 2-sided 95% CI for the difference between the 2 groups \> -10%.|Difference|-0.4||||||95.0|-3.7|2.8||||||For serotype 9V the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||2.8|-3.7|
72400453|NCT01876485|144308787|SUPERIORITY||Mean Difference (Final Values)|0.43||||0.003|TWO_SIDED||||||proc mixed in SAS (multilevel modeling)|Numerator degrees of freedom = 1 for both models (4mo and 10mo) and denominator degrees of freedom vary based on multiple imputation.||"We compared group differences in HbA1c at 4. The value of HbA1c at 4 months was the dependent variable, treatment group was the independent variable, and baseline HbA1c was a covariate.~Power calculations were based on effect sizes for the HbA1c in similar trial that revealed small-to-medium effect sizes. Our goal was to include 130 patients in each arm. The randomized samples (n = 140 EPIC, n = 140 EUC) exceed the required 130 per group."||||0.003
72400454|NCT01876485|144308787|SUPERIORITY||Mean Difference (Final Values)|0.11||||0.6|TWO_SIDED||||||proc mixed in SAS (multilevel modeling)|Numerator degrees of freedom = 1 for both models (4mo and 10mo) and denominator degrees of freedom vary based on multiple imputation.||"We compared group differences in HbA1c at 10 months. The value of HbA1c at 10 months was the dependent variable, treatment group was the independent variable, and baseline HbA1c was a covariate.~Power calculations were based on effect sizes for the HbA1c in similar trial that revealed small-to-medium effect sizes. Our goal was to include 130 patients in each arm. The randomized samples (n = 140 EPIC, n = 140 EUC) exceed the required 130 per group."||||.60
72400455|NCT01876485|144308788|SUPERIORITY||Mean Difference (Final Values)|0.3||||0.003|TWO_SIDED||||||proc mixed in SAS (multilevel modeling)|||We compared group differences in DDS at 4 months. The value of DDS at 4 months was the dependent variable, treatment group was the independent variable, and baseline DDS was a covariate. Power calculations were based on effect sizes for the DDS in similar trial that revealed small-to-medium effect sizes. Our goal was to include 130 patients in each arm. The randomized samples (n=138 EPIC, n=135 EUC) exceed the required 130 per group.||||0.003
72479595|NCT00706433|144485201|SUPERIORITY_OR_OTHER|||||||0.782||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.7820
72479596|NCT00706433|144485202|SUPERIORITY_OR_OTHER|||||||0.4965||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.4965
72479597|NCT00706433|144485203|SUPERIORITY_OR_OTHER|||||||0.0728||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.0728
72479598|NCT00706433|144485204|SUPERIORITY_OR_OTHER|||||||0.548||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.5480
72479599|NCT00706433|144485205|SUPERIORITY_OR_OTHER|||||||0.0301||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.0301
72509592|NCT00366548|144549961|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lowest limit of the 2-sided 95% CI for the difference between the 2 groups \> -10%.|Difference|-2.9||||||95.0|-6.9|0.7||||||For serotype 14 the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||0.7|-6.9|
72479600|NCT00706433|144485205|SUPERIORITY_OR_OTHER|||||||0.0564||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.0564
72479601|NCT00706433|144485205|SUPERIORITY_OR_OTHER|||||||0.447||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.4470
72479602|NCT00706433|144485205|SUPERIORITY_OR_OTHER|||||||0.2804||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.2804
72479603|NCT00706433|144485205|SUPERIORITY_OR_OTHER|||||||0.1835||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.1835
72479604|NCT00706433|144485205|SUPERIORITY_OR_OTHER|||||||0.0103||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.0103
72479605|NCT00706433|144485205|SUPERIORITY_OR_OTHER|||||||0.1319||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.1319
72479606|NCT00706433|144485206|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||1.0
72479607|NCT00706433|144485207|SUPERIORITY_OR_OTHER|||||||0.4378||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.4378
72479608|NCT00706433|144485208|SUPERIORITY_OR_OTHER|||||||0.343||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.3430
72479609|NCT00706433|144485209|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||1.0
72479610|NCT00706433|144485210|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||1.0
72509593|NCT00366548|144549961|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lowest limit of the 2-sided 95% CI for the difference between the 2 groups \> -10%.|Difference|0.0||||||95.0|-3.0|3.0||||||For serotype 18C the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||3.0|-3.0|
72509594|NCT00366548|144549961|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lowest limit of the 2-sided 95% CI for the difference between the 2 groups \> -10%.|Difference|-2.5||||||95.0|-6.1|0.6||||||For serotype 19F the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||0.6|-6.1|
72566589|NCT00118378|144663410|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|95.0|||||ANCOVA|||||||<0.001
72566590|NCT00118378|144663411|SUPERIORITY_OR_OTHER|||||||0.15|TWO_SIDED|95.0|||||ANOVA|||Week 4 CD4 cell count||||.150
72400456|NCT01876485|144308788|SUPERIORITY||Mean Difference (Final Values)|0.32||||0.003|TWO_SIDED||||||proc mixed in SAS (multilevel modeling)|||We compared group differences in DDS at 10 months. The value of DDS at 10 months was the dependent variable, treatment group was the independent variable, and baseline DDS was a covariate. Power calculations were based on effect sizes for the DDS in similar trial that revealed small-to-medium effect sizes. Our goal was to include 130 patients in each arm. The randomized samples (n=138 EPIC, n=135 EUC) exceed the required 130 per group.||||.003
72479611|NCT00706433|144485211|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||1.0
72400457|NCT04447417|144308799|OTHER||Point estimate|0.43|||<=|0.0001|TWO_SIDED|90.0|0.37|0.49||One-sided p-value. Threshold for significance at 0.05 level.|linear mixed model||Point estimate obtained was back-transformed by exponentiation|TEWL data for linear mixed model was log-transformed to account for right skewness of data and heteroskedasticity. The linear mixed effect on log (TEWL) included age, sex, number of STS, localization on the body, visit, number of STS-by-visit interaction and number of STS-by-age interaction as fixed effects. Model was run on data on lesional skin area.||0.49|0.37|<=0.0001
72479612|NCT00706433|144485212|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||1.0
72479613|NCT00706433|144485213|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||1.0
72566591|NCT00118378|144663412|SUPERIORITY_OR_OTHER|||||||0.459|TWO_SIDED|95.0|||||ANOVA|||||||.459
72566592|NCT02516410|144663413|SUPERIORITY||Least squares (LS) mean difference|1.2|||=|0.1176|TWO_SIDED|95.0|-0.3|2.6|||Mixed-effect repeated measure (MMRM)|||||2.6|-0.3|= 0.1176
72566593|NCT00773734|144663443|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|5.6||||0.1846|TWO_SIDED|95.0|-2.6|13.7|||Chi-squared|||||13.7|-2.6|0.1846
72566594|NCT00773734|144663443|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|23.1|||<|0.0001|TWO_SIDED|95.0|12.4|33.7|||Chi-squared|||||33.7|12.4|<0.0001
72566595|NCT00773734|144663443|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|35.2|||<|0.0001|TWO_SIDED|95.0|23.9|46.6|||Chi-squared|||||46.6|23.9|<0.0001
72400458|NCT01190254|144308829|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares (LS) Means|-4.8||||0.07|TWO_SIDED|95.0|-9.9|0.4||p-value is adjusted by Hochberg's method for testing two asenapine groups versus the placebo group|Mixed Model for Repeated Measures (MMRM)|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 100, asenapine 2.5 mg - 96, asenapine - 104)||0.4|-9.9|0.070
72400459|NCT01190254|144308829|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-5.6||||0.064|TWO_SIDED|95.0|-10.7|-0.5||p-value is adjusted by Hochberg's method for testing two asenapine groups versus the placebo group|MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 100, asenapine 2.5 mg - 96, asenapine - 104)||-0.5|-10.7|0.064
72400460|NCT01190254|144308829|SUPERIORITY_OR_OTHER_LEGACY|||||||0.064||||||p-value (adjusted to control Type I error in multiple testing) for Linear dose-response pattern (Placebo\<2.5 mg\<5.0 mg)|MMRM|||Investigation of dose-response relationship of change from baseline to Day 56 in PANSS Total Score was a Secondary study endpoint. Multiple contrast testing using MMRM model was used to evaluate 3 pre-defined dose-response patterns (Linear, Convex, Concave)||||0.064
72400461|NCT01190254|144308829|SUPERIORITY_OR_OTHER_LEGACY|||||||0.046||||||p-value (adjusted to control Type I error in multiple testing) for Convex dose-response pattern (Placebo\<2.5 mg=5.0 mg)|MMRM|||Investigation of dose-response relationship of change from baseline to Day 56 in PANSS Total Score was a Secondary study endpoint. Multiple contrast testing using MMRM model was used to evaluate 3 pre-defined dose-response patterns (Linear, Convex, Concave)||||0.046
72400462|NCT01190254|144308829|SUPERIORITY_OR_OTHER_LEGACY|||||||0.273||||||p-value (adjusted to control Type I error in multiple testing) for Concave dose-response pattern (Placebo=2.5 mg\<5.0 mg)|MMRM|||Investigation of dose-response relationship of change from baseline to Day 56 in PANSS Total Score was a Secondary study endpoint. Multiple contrast testing using MMRM model was used to evaluate 3 pre-defined dose-response patterns (Linear, Convex, Concave)||||0.273
72479614|NCT00706433|144485214|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||1.0
72479615|NCT00706433|144485215|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||1.0
72479616|NCT00706433|144485216|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||1.0
72479617|NCT00706433|144485217|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||1.0
72479618|NCT00706433|144485218|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||1.0
72566596|NCT00773734|144663445|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|13.2||||0.059|TWO_SIDED|95.0|-0.4|26.8|||Chi-squared|||||26.8|-0.4|0.0590
72566597|NCT00773734|144663445|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|22.1||||0.0023|TWO_SIDED|95.0|8.3|36.0|||Chi-squared|||||36.0|8.3|0.0023
72566598|NCT00773734|144663445|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|35.2|||<|0.0001|TWO_SIDED|95.0|21.6|48.9|||Chi-squared|||||48.9|21.6|<0.0001
72566599|NCT00773734|144663447|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|3.4||||0.1776|TWO_SIDED|95.0|-1.5|8.2|||Chi-squared|||||8.2|-1.5|0.1776
72566600|NCT00773734|144663447|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|8.1||||0.0158|TWO_SIDED|95.0|1.6|14.5|||Chi-squared|||||14.5|1.6|0.0158
72566601|NCT00773734|144663447|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|10.2||||0.0051|TWO_SIDED|95.0|3.2|17.2|||Chi-squared|||||17.2|3.2|0.0051
72509595|NCT00366548|144549961|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lowest limit of the 2-sided 95% CI for the difference between the 2 groups \> -10%.|Difference|-6.3||||||95.0|-12.1|-0.7||||||For serotype 23F the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||-0.7|-12.1|
72509596|NCT00366548|144549961|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lowest limit of the 2-sided 95% CI for the difference between the 2 groups \> -10%.|Difference|3.4||||||95.0|-0.9|7.9||||||For serotype 1 the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||7.9|-0.9|
72400463|NCT01190254|144308830|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.2||||0.218|TWO_SIDED|95.0|-0.5|0.1|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Confirmative testing for the key secondary endpoint was to be performed only if both asenapine doses were superior to placebo in change from baseline in PANSS total score at Day 56 (hypotheses associated with Primary outcome measure). If this did not occur, no confirmative testing could be performed and multiplicity unadjusted p-values are provided. Model uses efficacy FAS population (number of participants: placebo - 100, asenapine 2.5 mg - 96, asenapine - 104)||0.1|-0.5|0.218
72400464|NCT01190254|144308830|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.3||||0.024||95.0|-0.6|0.0|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Confirmative testing for the key secondary endpoint was to be performed only if both asenapine doses were superior to placebo in change from baseline in PANSS total score at Day 56 (hypotheses associated with Primary outcome measure). If this did not occur, no confirmative testing could be performed and multiplicity unadjusted p-values are provided. Model uses efficacy FAS population (number of participants: placebo - 100, asenapine 2.5 mg - 96, asenapine - 104)||-0.0|-0.6|0.024
72400465|NCT01190254|144308831|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-1.6||||0.067|TWO_SIDED|95.0|-3.3|0.1|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 100, asenapine 2.5 mg - 96, asenapine - 104)||0.1|-3.3|0.067
72400466|NCT01190254|144308831|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-2.1||||0.012|TWO_SIDED|95.0|-3.8|-0.5|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 100, asenapine 2.5 mg - 96, asenapine - 104)||-0.5|-3.8|0.012
72400467|NCT01190254|144308832|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-1.2||||0.097|TWO_SIDED|95.0|-2.6|0.2|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 100, asenapine 2.5 mg - 96, asenapine - 104)||0.2|-2.6|0.097
72400468|NCT01190254|144308832|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-1.2||||0.099|TWO_SIDED|95.0|-2.6|0.2|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 100, asenapine 2.5 mg - 96, asenapine - 104)||0.2|-2.6|0.099
72400469|NCT01190254|144308833|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-2.7||||0.062|TWO_SIDED|95.0|-5.6|0.1|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 100, asenapine 2.5 mg - 96, asenapine - 104)||0.1|-5.6|0.062
72400470|NCT01190254|144308833|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-3.2||||0.025|TWO_SIDED|95.0|-6.0|-0.4|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 100, asenapine 2.5 mg - 96, asenapine - 104)||-0.4|-6.0|0.025
72400471|NCT01190254|144308834|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-2.1||||0.098|TWO_SIDED|95.0|-4.6|0.4|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 100, asenapine 2.5 mg - 96, asenapine - 104)||0.4|-4.6|0.098
72400472|NCT01190254|144308834|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-2.3||||0.071|TWO_SIDED|95.0|-4.8|0.2|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 100, asenapine 2.5 mg - 96, asenapine - 104)||0.2|-4.8|0.071
72400473|NCT01190254|144308835|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-1.4||||0.106|TWO_SIDED|95.0|-3.1|0.3|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 100, asenapine 2.5 mg - 96, asenapine - 104)||0.3|-3.1|0.106
72479619|NCT00706433|144485219|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||1.0
72479620|NCT00706433|144485220|SUPERIORITY_OR_OTHER|||||||0.0165||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.0165
72479621|NCT00706433|144485220|SUPERIORITY_OR_OTHER|||||||0.2252||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.2252
72479622|NCT00706433|144485220|SUPERIORITY_OR_OTHER|||||||0.0179||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.0179
72479623|NCT00706433|144485220|SUPERIORITY_OR_OTHER|||||||0.0233||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.0233
72479624|NCT00706433|144485220|SUPERIORITY_OR_OTHER|||||||0.1573||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.1573
72479625|NCT00706433|144485220|SUPERIORITY_OR_OTHER|||||||0.2039||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.2039
72479626|NCT00706433|144485220|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||1.0
72479627|NCT00706433|144485221|SUPERIORITY_OR_OTHER|||||||0.1594||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.1594
72479628|NCT00706433|144485222|SUPERIORITY_OR_OTHER|||||||0.5838||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.5838
72479629|NCT00706433|144485223|SUPERIORITY_OR_OTHER|||||||0.0064||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.0064
72479630|NCT00706433|144485223|SUPERIORITY_OR_OTHER|||||||0.0939||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.0939
72479631|NCT00706433|144485223|SUPERIORITY_OR_OTHER|||||||0.3173||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.3173
72479632|NCT00706433|144485223|SUPERIORITY_OR_OTHER|||||||0.2207||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.2207
72509597|NCT00366548|144549961|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lowest limit of the 2-sided 95% CI for the difference between the 2 groups \> -10%.|Difference|-1.3||||||95.0|-4.1|1.1||||||For serotype 3 the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||1.1|-4.1|
72479633|NCT00706433|144485223|SUPERIORITY_OR_OTHER|||||||0.0183||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.0183
72479634|NCT00706433|144485223|SUPERIORITY_OR_OTHER|||||||0.0254||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.0254
72479635|NCT00706433|144485223|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||1.0
72509598|NCT00366548|144549961|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lowest limit of the 2-sided 95% CI for the difference between the 2 groups \> -10%.|Difference|1.7||||||95.0|-3.0|6.4||||||For serotype 5 the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||6.4|-3.0|
72479636|NCT00706433|144485224|SUPERIORITY_OR_OTHER|||||||0.4753||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.4753
72479637|NCT00706433|144485225|SUPERIORITY_OR_OTHER|||||||0.1728||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.1728
72479638|NCT00706433|144485226|SUPERIORITY_OR_OTHER|||||||0.0002||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.0002
72479639|NCT00706433|144485226|SUPERIORITY_OR_OTHER|||||||0.5313||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.5313
72479640|NCT00706433|144485226|SUPERIORITY_OR_OTHER|||||||0.0045||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.0045
72479641|NCT00706433|144485226|SUPERIORITY_OR_OTHER|||||||0.0045||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.0045
72479642|NCT00706433|144485226|SUPERIORITY_OR_OTHER|||||||0.0012||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.0012
72479643|NCT00706433|144485226|SUPERIORITY_OR_OTHER|||||||0.0015||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.0015
72479644|NCT00706433|144485226|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||1.0
72479645|NCT00706433|144485227|SUPERIORITY_OR_OTHER|||||||0.0892||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.0892
72479646|NCT00706433|144485228|SUPERIORITY_OR_OTHER|||||||0.4575||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.4575
72509599|NCT00366548|144549961|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lowest limit of the 2-sided 95% CI for the difference between the 2 groups \> -10%.|Difference|0.4||||||95.0|-5.8|6.7||||||For serotype 6A the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||6.7|-5.8|
72566602|NCT00773734|144663452|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-13.7||||0.0156|TWO_SIDED|95.0|-24.8|-2.6|||ANCOVA|Analysis of covariance model with treatment group as a factor and the baseline value as a covariate.||||-2.6|-24.8|0.0156
72509600|NCT00366548|144549961|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lowest limit of the 2-sided 95% CI for the difference between the 2 groups \> -10%.|Difference|-0.8||||||95.0|-3.2|1.2||||||For serotype 7F the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||1.2|-3.2|
72509601|NCT00366548|144549961|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lowest limit of the 2-sided 95% CI for the difference between the 2 groups \> -10%.|Difference|-1.3||||||95.0|-3.6|0.3||||||For serotype 19A the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||0.3|-3.6|
72509602|NCT00366548|144549962|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lowest limit of the 2-sided 95% CI for the difference between the 2 groups \> -10%.|Difference|0.0||||||95.0|-2.1|1.9||||||For serotype 4 the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated.||1.9|-2.1|
72509603|NCT00366548|144549962|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lowest limit of the 2-sided 95% CI for the difference between the 2 groups \> -10%.|Difference|0.4||||||95.0|-1.7|2.6||||||For serotype 6B the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated.||2.6|-1.7|
72509604|NCT00366548|144549962|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lowest limit of the 2-sided 95% CI for the difference between the 2 groups \> -10%.|Difference|-0.4||||||95.0|-2.4|1.1||||||For serotype 9V the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||1.1|-2.4|
72509605|NCT00366548|144549962|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lowest limit of the 2-sided 95% CI for the difference between the 2 groups \> -10%.|Difference|0.0||||||95.0|-2.1|1.9||||||For serotype 14 the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||1.9|-2.1|
72509606|NCT00366548|144549962|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lowest limit of the 2-sided 95% CI for the difference between the 2 groups \> -10%.|Difference|0.4||||||95.0|-1.2|2.3||||||For serotype 18C the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||2.3|-1.2|
72509607|NCT00366548|144549962|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lowest limit of the 2-sided 95% CI for the difference between the 2 groups \> -10%.|Difference|0.4||||||95.0|-2.0|2.9||||||For serotype 19F the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||2.9|-2.0|
72509608|NCT00366548|144549962|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lowest limit of the 2-sided 95% CI for the difference between the 2 groups \> -10%.|Difference|-0.9||||||95.0|-3.4|1.1||||||For serotype 23F the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||1.1|-3.4|
72509609|NCT00366548|144549962|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lowest limit of the 2-sided 95% CI for the difference between the 2 groups \> -10%.|Difference|0.8||||||95.0|-0.8|3.0||||||For serotype 1 the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||3.0|-0.8|
72509610|NCT00366548|144549962|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lowest limit of the 2-sided 95% CI for the difference between the 2 groups \> -10%.|Difference|0.6||||||95.0|-3.7|4.9||||||For serotype 3 the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||4.9|-3.7|
72509611|NCT00366548|144549962|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lowest limit of the 2-sided 95% CI for the difference between the 2 groups \> -10%.|Difference|-0.4||||||95.0|-2.4|1.1||||||For serotype 5 the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||1.1|-2.4|
72509612|NCT00366548|144549962|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lowest limit of the 2-sided 95% CI for the difference between the 2 groups \> -10%.|Difference|-0.4||||||95.0|-2.4|1.2||||||For serotype 6A the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||1.2|-2.4|
72509613|NCT00366548|144549962|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lowest limit of the 2-sided 95% CI for the difference between the 2 groups \> -10%.|Difference|0.0||||||95.0|-1.7|1.6||||||For serotype 7F the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||1.6|-1.7|
72509614|NCT00366548|144549962|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lowest limit of the 2-sided 95% CI for the difference between the 2 groups \> -10%.|Difference|0.0||||||95.0|-1.7|1.6||||||For serotype 19A the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||1.6|-1.7|
72509615|NCT00366548|144549965|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the GMC ratio (13vPnC/7vPnC) \> 0.5 (2-fold criterion).|Difference|0.96||||||95.0|0.81|1.13||||||For serotype 4 the GMC ratio (13vPnC/7vPnC) was calculated||1.13|0.81|
72509616|NCT00366548|144549965|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the GMC ratio (13vPnC/7vPnC) \> 0.5 (2-fold criterion).|Difference|0.9||||||95.0|0.72|1.14||||||For serotype 6B the GMC ratio (13vPnC/7vPnC) was calculated||1.14|0.72|
72509617|NCT00366548|144549965|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the GMC ratio (13vPnC/7vPnC) \> 0.5 (2-fold criterion).|Difference|0.97||||||95.0|0.85|1.1||||||For serotype 9V the GMC ratio (13vPnC/7vPnC) was calculated||1.10|0.85|
72509618|NCT00366548|144549965|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the GMC ratio (13vPnC/7vPnC) \> 0.5 (2-fold criterion).|Difference|0.96||||||95.0|0.79|1.15||||||For serotype 14 the GMC ratio (13vPnC/7vPnC) was calculated||1.15|0.79|
72509619|NCT00366548|144549965|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the GMC ratio (13vPnC/7vPnC) \> 0.5 (2-fold criterion).|Difference|0.98||||||95.0|0.86|1.13||||||For serotype 18C the GMC ratio (13vPnC/7vPnC) was calculated||1.13|0.86|
72509620|NCT00366548|144549965|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the GMC ratio (13vPnC/7vPnC) \> 0.5 (2-fold criterion).|Difference|0.84||||||95.0|0.72|0.97||||||For serotype 19F the GMC ratio (13vPnC/7vPnC) was calculated||0.97|0.72|
72566603|NCT00773734|144663452|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-25.1|||<|0.0001|TWO_SIDED|95.0|-36.4|-13.9|||ANCOVA|Analysis of covariance model with treatment group as a factor and the baseline value as a covariate.||||-13.9|-36.4|<0.0001
72400474|NCT01190254|144308835|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-1.9||||0.026|TWO_SIDED|95.0|-3.6|-0.2|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 100, asenapine 2.5 mg - 96, asenapine - 104)||-0.2|-3.6|0.026
72479647|NCT00706433|144485229|SUPERIORITY_OR_OTHER|||||||0.8848||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.8848
72479648|NCT00706433|144485230|SUPERIORITY_OR_OTHER|||||||0.0008||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.0008
72479649|NCT00706433|144485230|SUPERIORITY_OR_OTHER|||||||0.4091||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.4091
72479650|NCT00706433|144485230|SUPERIORITY_OR_OTHER|||||||0.0176||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.0176
72479651|NCT00706433|144485230|SUPERIORITY_OR_OTHER|||||||0.0245||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.0245
72479652|NCT00706433|144485230|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.0020
72479653|NCT00706433|144485230|SUPERIORITY_OR_OTHER|||||||0.0022||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.0022
72479654|NCT00706433|144485230|SUPERIORITY_OR_OTHER|||||||0.9372||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.9372
72479655|NCT00706433|144485231|SUPERIORITY_OR_OTHER|||||||0.239||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.2390
72479656|NCT00706433|144485232|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||1.0
72509621|NCT00366548|144549965|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the GMC ratio (13vPnC/7vPnC) \> 0.5 (2-fold criterion).|Difference|0.84||||||95.0|0.71|0.98||||||For serotype 23F the GMC ratio (13vPnC/7vPnC) was calculated||0.98|0.71|
72509622|NCT00366548|144549965|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the GMC ratio (13vPnC/7vPnC) \> 0.5 (2-fold criterion).|Difference|0.94||||||95.0|0.81|1.1||||||For serotype 1 the GMC ratio (13vPnC/7vPnC) was calculated||1.10|0.81|
72509623|NCT00366548|144549965|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the GMC ratio (13vPnC/7vPnC) \> 0.5 (2-fold criterion).|Difference|0.93||||||95.0|0.83|1.04||||||For serotype 3 the GMC ratio (13vPnC/7vPnC) was calculated||1.04|0.83|
72479657|NCT00706433|144485233|SUPERIORITY_OR_OTHER|||||||0.0463||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.0463
72479658|NCT00706433|144485233|SUPERIORITY_OR_OTHER|||||||0.1261||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.1261
72479659|NCT00706433|144485233|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||1.0
72479660|NCT00706433|144485233|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||1.0
72479661|NCT00706433|144485233|SUPERIORITY_OR_OTHER|||||||0.0947||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.0947
72479662|NCT00706433|144485233|SUPERIORITY_OR_OTHER|||||||0.0886||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.0886
72509624|NCT00366548|144549965|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the GMC ratio (13vPnC/7vPnC) \> 0.5 (2-fold criterion).|Difference|0.97||||||95.0|0.83|1.13||||||For serotype 5 the GMC ratio (13vPnC/7vPnC) was calculated||1.13|0.83|
72509625|NCT00366548|144549965|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the GMC ratio (13vPnC/7vPnC) \> 0.5 (2-fold criterion).|Difference|0.96||||||95.0|0.81|1.13||||||For serotype 6A the GMC ratio (13vPnC/7vPnC) was calculated||1.13|0.81|
72509626|NCT00366548|144549965|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the GMC ratio (13vPnC/7vPnC) \> 0.5 (2-fold criterion).|Difference|1.05||||||95.0|0.93|1.18||||||For serotype 7F the GMC ratio (13vPnC/7vPnC) was calculated||1.18|0.93|
72509627|NCT00366548|144549965|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the GMC ratio (13vPnC/7vPnC) \> 0.5 (2-fold criterion).|Difference|0.91||||||95.0|0.8|1.04||||||For serotype 19A the GMC ratio (13vPnC/7vPnC) was calculated||1.04|0.80|
72509628|NCT02297438|144549984|SUPERIORITY||Hazard Ratio (HR)|0.677||||0.0012|TWO_SIDED|95.0|0.529|0.867||1-sided p-value from the adjusted log-rank test.|Log Rank||Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of Palbociclib + Letrozole.|Stratified by disease site (visceral vs. non-visceral) per Randomization.||0.867|0.529|0.0012
72400475|NCT01190254|144308836|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-1.2||||0.083|TWO_SIDED|95.0|-2.6|0.2|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 100, asenapine 2.5 mg - 96, asenapine - 104)||0.2|-2.6|0.083
72400476|NCT01190254|144308836|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-1.3||||0.067|TWO_SIDED|95.0|-2.7|0.1|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 100, asenapine 2.5 mg - 96, asenapine - 104)||0.1|-2.7|0.067
72479663|NCT00706433|144485233|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||1.0
72479664|NCT00706433|144485234|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||<0.0001
72566604|NCT00773734|144663452|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-32.9|||<|0.0001|TWO_SIDED|95.0|-44.0|-21.7|||ANCOVA|Analysis of covariance model with treatment group as a factor and the baseline value as a covariate.||||-21.7|-44.0|<0.0001
72400477|NCT01190254|144308837|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.9||||0.131|TWO_SIDED|95.0|-2.1|0.3|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 100, asenapine 2.5 mg - 96, asenapine - 104)||0.3|-2.1|0.131
72400478|NCT01190254|144308837|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.9||||0.135|TWO_SIDED|95.0|-2.1|0.3|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 100, asenapine 2.5 mg - 96, asenapine - 104)||0.3|-2.1|0.135
72400479|NCT01190254|144308838|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-1.0||||0.071|TWO_SIDED|95.0|-2.0|0.1|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 100, asenapine 2.5 mg - 96, asenapine - 104)||0.1|-2.0|0.071
72479665|NCT00706433|144485234|SUPERIORITY_OR_OTHER|||||||0.0255||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.0255
72400480|NCT01190254|144308838|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.8||||0.12|TWO_SIDED|95.0|-1.9|0.2|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 100, asenapine 2.5 mg - 96, asenapine - 104)||0.2|-1.9|0.120
72400481|NCT01190254|144308839|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.4||||0.263|TWO_SIDED|95.0|-1.2|0.3|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 100, asenapine 2.5 mg - 96, asenapine - 104)||0.3|-1.2|0.263
72400482|NCT01190254|144308839|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.5||||0.146|TWO_SIDED|95.0|-1.3|0.2|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 100, asenapine 2.5 mg - 96, asenapine - 104)||0.2|-1.3|0.146
72400483|NCT01190254|144308840|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.0||||0.028|TWO_SIDED|95.0|1.1|3.6||95% Confidence Interval and p-value are based on Wald statistic|Regression, Logistic|Model included terms of (pooled) site, treatment, and baseline PANSS Total Score|OR was adjusted for baseline and (pooled) site. An OR of \>1 is considered to mean that asenapine has a higher probability of achieving Total PANSS 30% response|||3.6|1.1|0.028
72400484|NCT01190254|144308840|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.8||||0.048|TWO_SIDED|95.0|1.0|3.3||95% Confidence Interval and p-value are based on Wald statistic|Regression, Logistic|Model included terms of (pooled) site, treatment, and baseline PANSS Total Score|OR was adjusted for baseline and (pooled) site. An OR of \>1 is considered to mean that asenapine has a higher probability of achieving Total PANSS 30% response|||3.3|1.0|0.048
72400485|NCT01190254|144308841|SUPERIORITY_OR_OTHER_LEGACY|||||||0.576||||||p-value is for Log Rank test of difference in time to event (PANSS 30% response) curves between the three treatment groups|Log Rank|||||||0.576
72400486|NCT01190254|144308841|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.3||||0.171|TWO_SIDED|95.0|0.9|2.0|||Regression, Cox|Model included factors for (pooled) site, treatment and baseline PANSS Total Score|An HR of \>1 is considered to mean that asenapine has a higher likelihood of being a Total PANSS 30% Responder than placebo|||2.0|0.9|0.171
72400487|NCT01190254|144308841|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.2||||0.368|TWO_SIDED|95.0|0.8|1.8|||Regression, Cox|Model included factors for (pooled) site, treatment and baseline PANSS Total Score|An HR of \>1 is considered to mean that asenapine has a higher likelihood of being a Total PANSS 30% Responder than placebo|||1.8|0.8|0.368
72400488|NCT01190254|144308842|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.3||||0.094|TWO_SIDED|95.0|-0.6|0.0|||MMRM|Model included terms of (pooled) site, treatment, visit, and the interaction of visit by treatment|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 100, asenapine 2.5 mg - 96, asenapine - 104)||0.0|-0.6|0.094
72479666|NCT00706433|144485234|SUPERIORITY_OR_OTHER|||||||0.0576||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.0576
72479667|NCT00706433|144485234|SUPERIORITY_OR_OTHER|||||||0.0686||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.0686
72479668|NCT00706433|144485234|SUPERIORITY_OR_OTHER|||||||0.0004||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.0004
72400489|NCT01190254|144308842|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.5||||0.003|TWO_SIDED|95.0|-0.8|-0.2|||MMRM|Model included terms of (pooled) site, treatment, visit, and the interaction of visit by treatment|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 100, asenapine 2.5 mg - 96, asenapine - 104)||-0.2|-0.8|0.003
72400490|NCT01190254|144308843|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.5||||0.177|TWO_SIDED|95.0|0.8|2.8||95% Confidence Interval and p-value are based on Wald statistic|Regression, Logistic|Model included terms of region (Asia-Pacific, North America, Eastern Europe \[Africa/Latin America sites assigned to this region\]) and treatment|OR was adjusted for region. An OR of \>1 is considered to mean that asenapine has a higher probability of achieving CGI-I response|||2.8|0.8|0.177
72400491|NCT01190254|144308843|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.6||||0.114|TWO_SIDED|95.0|0.9|2.9||95% Confidence Interval and p-value are based on Wald statistic|Regression, Logistic|Model included terms of region (Asia-Pacific, North America, Eastern Europe \[Africa/Latin America sites assigned to this region\]) and treatment|OR was adjusted for region. An OR of \>1 is considered to mean that asenapine has a higher probability of achieving CGI-I response|||2.9|0.9|0.114
72509629|NCT02297438|144549985|SUPERIORITY||Hazard Ratio (HR)|0.861||||0.14778|TWO_SIDED|95.0|0.651|1.139||1-sided p-value from the log-rank test.|Log Rank||Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of Palbociclib + Letrozole.|Stratified by disease site (visceral versus non-visceral) per Randomization.||1.139|0.651|0.14778
72509630|NCT02297438|144549986|SUPERIORITY||Odds Ratio (OR)|1.301||||0.154|TWO_SIDED|95.0|0.805|2.1||1-sided p-value was from exact test.|Fisher Exact||An Odds Ratio \>1 means better response in favor of Palbociclib + Letrozole group.|Stratified by disease site (visceral versus non-visceral) per Randomization.||2.100|0.805|0.154
72400492|NCT01190254|144308844|SUPERIORITY_OR_OTHER_LEGACY|||||||0.057||||||p-value is for Log Rank test of difference in time to event (CGI-I response) curves between the three treatment groups|Log Rank|||||||0.057
72400493|NCT01190254|144308844|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.4||||0.135|TWO_SIDED|95.0|0.9|2.3|||Regression, Cox|Model included factors for (pooled) site and treatment|An HR of \>1 is considered to mean that asenapine has a higher likelihood of being a CGI-I Responder than placebo|||2.3|0.9|0.135
72400494|NCT01190254|144308844|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.8||||0.01|TWO_SIDED|95.0|1.2|2.9|||Regression, Cox|Model included factors for (pooled) site and treatment|An HR of \>1 is considered to mean that asenapine has a higher likelihood of being a CGI-I Responder than placebo|||2.9|1.2|0.010
72400495|NCT01190254|144308845|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|1.4||||0.417|TWO_SIDED|95.0|-2.0|4.8|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 100, asenapine 2.5 mg - 96, asenapine - 104)||4.8|-2.0|0.417
72400496|NCT01190254|144308845|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|4.2||||0.017|TWO_SIDED|95.0|0.8|7.6|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 100, asenapine 2.5 mg - 96, asenapine - 104)||7.6|0.8|0.017
72479669|NCT00706433|144485234|SUPERIORITY_OR_OTHER|||||||0.0005||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.0005
72479670|NCT00706433|144485234|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||1.0
72479671|NCT00706433|144485235|SUPERIORITY_OR_OTHER|||||||0.0006||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.0006
72479672|NCT00706433|144485235|SUPERIORITY_OR_OTHER|||||||0.0245||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.0245
72400497|NCT01190254|144308846|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|0.6||||0.6|TWO_SIDED|95.0|-1.6|2.8|||ANCOVA|Model included terms of (pooled) site, treatment, and baseline|Estimate is asenapine versus placebo|||2.8|-1.6|0.600
72400498|NCT01190254|144308846|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|2.1||||0.064|TWO_SIDED|95.0|-0.1|4.3|||ANCOVA|Model included terms of (pooled) site, treatment, and baseline|Estimate is asenapine versus placebo|||4.3|-0.1|0.064
72400499|NCT01190254|144308847|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|0.1||||0.407|TWO_SIDED|95.0|-0.13|0.33|||ANCOVA|Model included terms of (pooled) site, treatment, and baseline|Estimate is asenapine versus placebo|||0.33|-0.13|0.407
72400500|NCT01190254|144308847|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|0.19||||0.111|TWO_SIDED|95.0|-0.04|0.42|||ANCOVA|Model included terms of (pooled) site, treatment, and baseline|Estimate is asenapine versus placebo|||0.42|-0.04|0.111
72400501|NCT04729127|144308850|OTHER|||||||0.79|||||||Regression, Linear|||See protocol for full statistical analysis plan.||||.79
72479673|NCT00706433|144485235|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||1.0
72479674|NCT00706433|144485235|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||1.0
72479675|NCT00706433|144485235|SUPERIORITY_OR_OTHER|||||||0.0097||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.0097
72509631|NCT02297438|144549987|SUPERIORITY||Odds Ratio (OR)|1.255||||0.206|TWO_SIDED|95.0|0.762|2.066||1-sided p-value was from exact test.|Fisher Exact||An Odds Ratio \>1 means better response in favor of Palbociclib + Letrozole group.|Stratified by disease site (visceral versus non-visceral) per Randomization.||2.066|0.762|0.206
72509632|NCT02297438|144549988|SUPERIORITY||Odds Ratio (OR)|1.315||||0.135|TWO_SIDED|95.0|0.825|2.095||1-sided p-value was from exact test.|Fisher Exact||An Odds Ratio \>1 means better response in favor of Palbociclib + Letrozole group.|Stratified by disease site (visceral versus non-visceral) per Randomization.||2.095|0.825|0.135
72509633|NCT02297438|144549989|SUPERIORITY||Odds Ratio (OR)|1.392||||0.117|TWO_SIDED|95.0|0.825|2.346||1-sided p-value was from exact test.|Fisher Exact||An Odds Ratio \>1 means better response in favor of Palbociclib + Letrozole group.|Stratified by disease site (visceral versus non-visceral) per Randomization.||2.346|0.825|0.117
72509634|NCT02297438|144549992|SUPERIORITY||Odds Ratio (OR)|0.945||||0.471|TWO_SIDED|95.0|0.533|1.673||1-sided p-value was from exact test.|Fisher Exact||An Odds Ratio \>1 means better response in favor of Palbociclib + Letrozole group.|Stratified by disease site (visceral versus non-visceral) per Randomization.||1.673|0.533|0.471
72509635|NCT02297438|144549993|SUPERIORITY||Odds Ratio (OR)|0.878||||0.383|TWO_SIDED|95.0|0.474|1.621||1-sided p-value was from exact test.|Fisher Exact||An Odds Ratio \>1 means better response in favor of Palbociclib + Letrozole group.|Stratified by disease site (visceral versus non-visceral) per Randomization.||1.621|0.474|0.383
72509636|NCT02297438|144549994|SUPERIORITY||Odds Ratio (OR)|1.227||||0.248|TWO_SIDED|95.0|0.725|2.082||1-sided p-value was from exact test.|Fisher Exact||An Odds Ratio \>1 means better response in favor of Palbociclib + Letrozole group.|Stratified by disease site (visceral versus non-visceral) per Randomization.||2.082|0.725|0.248
72400502|NCT04729127|144308850|OTHER|||||||0.27|||||||Regression, Linear|||See protocol for full statistical analysis plan.||||.27
72479676|NCT00706433|144485235|SUPERIORITY_OR_OTHER|||||||0.0146||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.0146
72479677|NCT00706433|144485235|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||1.0
72479678|NCT00706433|144485236|SUPERIORITY_OR_OTHER|||||||0.4235||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.4235
72479679|NCT00706433|144485237|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||1.0
72479680|NCT00706433|144485238|SUPERIORITY_OR_OTHER|||||||0.0865||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.0865
72479681|NCT00706433|144485239|SUPERIORITY_OR_OTHER|||||||0.623||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.6230
72479682|NCT00706433|144485240|SUPERIORITY_OR_OTHER|||||||0.0963||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.0963
72479683|NCT00706433|144485241|SUPERIORITY_OR_OTHER|||||||0.4814||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.4814
72479684|NCT00706433|144485242|SUPERIORITY_OR_OTHER|||||||0.7153||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.7153
72479685|NCT00706433|144485243|SUPERIORITY_OR_OTHER|||||||0.3832||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.3832
72479686|NCT00706433|144485244|SUPERIORITY_OR_OTHER|||||||0.2908||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.2908
72479687|NCT00706433|144485245|SUPERIORITY_OR_OTHER|||||||0.8096||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.8096
72479688|NCT00706433|144485246|SUPERIORITY_OR_OTHER|||||||0.308||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.3080
72479689|NCT00706433|144485247|SUPERIORITY_OR_OTHER|||||||0.3208||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.3208
72509637|NCT02297438|144549995|SUPERIORITY||Odds Ratio (OR)|1.349||||0.189|TWO_SIDED|95.0|0.731|2.509||1-sided p-value was from exact test.|Fisher Exact||An Odds Ratio \>1 means better response in favor of Palbociclib + Letrozole group.|Stratified by disease site (visceral versus non-visceral) per Randomization.||2.509|0.731|0.189
72509638|NCT02297438|144549996|SUPERIORITY||Hazard Ratio (HR)|0.947||||0.36502|TWO_SIDED|95.0|0.698|1.286||1-sided p-value was from exact test.|Log Rank||Assuming Cox proportional hazards, hazard ratio less than 1 indicates reduction in hazard rate in favor of Palbociclib + Letrozole.|Stratified by disease site (visceral versus non-visceral) per Randomization.||1.286|0.698|0.36502
72509639|NCT02297438|144550003|SUPERIORITY||Mean|0.031||||0.1914|TWO_SIDED|95.0|-0.02|0.08|||Mixed effects model||A positive change indicates improvement from baseline and a negative change indicates deterioration.|The analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.||0.08|-0.02|0.1914
72509640|NCT02297438|144550004|SUPERIORITY||Mean|3.358||||0.0078|TWO_SIDED|95.0|0.88|5.83|||Mixed effects model||A positive change indicates improvement from baseline and a negative change indicates deterioration.|The analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.||5.83|0.88|0.0078
72509641|NCT02297438|144550005|SUPERIORITY||Mean|0.476||||0.7862|TWO_SIDED|95.0|-2.97|3.92|||Mixed effects model||A positive change indicates improvement from baseline and a negative change indicates deterioration.|The analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.||3.92|-2.97|0.7862
72509642|NCT03521154|144550013|SUPERIORITY||Hazard Ratio (HR)|0.16|||<|0.001|TWO_SIDED|95.0|0.1|0.24|||Log Rank||A hazard ratio \< 1 favours osimertinib|||0.24|0.10|<0.001
72400503|NCT04729127|144308851|OTHER|||||||0.04|||||||Regression, Linear|||See protocol for full statistical analysis plan.||||.04
72479690|NCT00706433|144485248|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||1.0
72479691|NCT00706433|144485249|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||1.0
72479692|NCT01236365|144485250|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Change in LDL-C between Atorvastatin and Placebo|Mixed Models Analysis|||||||<0.0001
72479693|NCT01236365|144485251|SUPERIORITY_OR_OTHER|||||||0.913|TWO_SIDED|||||Change in hsCRP (6months minus 0months) between Atorvastatin and Placebo|Wilcoxon (Mann-Whitney)|||||||0.913
72479694|NCT01236365|144485254|OTHER|||||||0.09|||||||t-test, 2 sided|||||||0.09
72479695|NCT00717067|144485255|SUPERIORITY_OR_OTHER||ratio of adjusted geometric means|129.17||||||90.0|92.16|181.04|||ANOVA|||Ratio (%) test (mild) / reference (normal). AUClast was calculated using the log-linear trapezoidal method.||181.04|92.16|
72479696|NCT00717067|144485255|SUPERIORITY_OR_OTHER||ratio of adjusted geometric means|88.31||||||90.0|61.97|125.83|||ANOVA|||Ratio (%) test (moderate) / reference (normal). AUClast was calculated using the log-linear trapezoidal method.||125.83|61.97|
72479697|NCT00717067|144485255|SUPERIORITY_OR_OTHER||ratio of adjusted geometric means|322.23||||||90.0|171.97|603.78|||ANOVA|||Ratio (%) test (severe) / reference (normal). AUClast was calculated using the log-linear trapezoidal method.||603.78|171.97|
72400504|NCT04729127|144308851|OTHER|||||||0.02|||||||Regression, Linear|||See protocol for full statistical analysis plan.||||.02
72400505|NCT04729127|144308852|OTHER|||||||0.78|||||||Regression, Linear|||See protocol for full statistical analysis plan.||||.78
72400506|NCT04729127|144308852|OTHER|||||||0.89|||||||Regression, Linear|||See protocol for full statistical analysis plan.||||.89
72400507|NCT04729127|144308853|OTHER|||||||0.07|||||||Regression, Linear|||See protocol for full statistical analysis plan.||||.07
72400508|NCT04729127|144308853|OTHER|||||||0.88|||||||Regression, Linear|||See protocol for full statistical analysis plan.||||.88
72400509|NCT04729127|144308856|OTHER|||||||0.26|||||||Regression, Linear|||See protocol for full statistical analysis plan.||||.26
72400510|NCT04729127|144308856|OTHER|||||||0.74|||||||Regression, Linear|||See protocol for full statistical analysis plan.||||.74
72400511|NCT02529137|144308902|NON_INFERIORITY|the non-inferiority margin was set at 4%|difference|0.4|||||TWO_SIDED|95.0|-0.3|1.01||||||||1.01|-0.30|
72400512|NCT03036098|144308907|SUPERIORITY||Hazard Ratio (HR)|0.79||||0.0032|TWO_SIDED|95.0|0.64|0.97|||Log Rank|Stratified weighted log-rank test||||0.97|0.64|0.0032
72400513|NCT03036098|144308914|SUPERIORITY||Hazard Ratio (HR)|0.72||||0.0018|TWO_SIDED|95.0|0.59|0.88|||Log Rank|Stratified weighted log-rank test||||0.88|0.59|0.0018
72400514|NCT03036098|144308915|SUPERIORITY||Hazard Ratio (HR)|0.78||||0.0171|TWO_SIDED|95.0|0.63|0.96|||Log Rank|Stratified weighted log-rank test||||0.96|0.63|0.0171
72400515|NCT00930579|144308920|OTHER|This study used two-sided t-tests to compare changes within group- before and after metformin treatment.|Mean Difference (Final Values)|-0.006||||0.98|TWO_SIDED||||||paired t-test|||Null hypothesis: there will be no statistically significant change between the amount of Ki-67 (protein involved in cell proliferation) in participants' tumor cells before and after taking the prescribed dose of Metformin, as measured at the 5% significance level.||||0.98
72400516|NCT01046682|144308932|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0|||||Wilcoxon rank sum test|||Using data from a different population, ie, patients with peripheral artery disease, and a different intervention, ie, omega-3 fatty acids, 15 participants were needed per group to achieve 80% power to detect a difference in means of -3.6% (the difference between the control group mean of -0.3% and a treatment group mean of 3.3%) assuming a common standard deviation of 3.3 using a two group t-test with a 0.05 two-sided significance level. 5 patients added to each arm in case nonparametric.||||<0.05
72400517|NCT00525733|144308954|SUPERIORITY_OR_OTHER|||||||0.46|TWO_SIDED||||||Chi-squared|||||||0.46
72400518|NCT00189228|144308972|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.01||95.0|||||t-test, 2 sided|||This is not a drug study.||||<0.01
72400519|NCT00867451|144308983|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||t-test, 1 sided|||||||<.05
72479698|NCT00717067|144485256|SUPERIORITY_OR_OTHER||ratio of adjusted geometric means|151.99||||||90.0|109.53|210.92|||ANOVA|||Ratio (%) test (mild) / reference (normal).||210.92|109.53|
72479699|NCT00717067|144485256|SUPERIORITY_OR_OTHER||ratio of adjusted geometric means|115.95||||||90.0|82.23|163.5|||ANOVA|||Ratio (%) test (moderate) / reference (normal).||163.50|82.23|
72479700|NCT00717067|144485257|SUPERIORITY_OR_OTHER||ratio of adjusted geometric means|121.01||||||90.0|83.15|176.13|||ANOVA|||Ratio (%) test (mild) / reference (normal).||176.13|83.15|
72479701|NCT00717067|144485257|SUPERIORITY_OR_OTHER||ratio of adjusted geometric means|70.9||||||90.0|47.83|105.1|||ANOVA|||Ratio (%) test (moderate) / reference (normal).||105.10|47.83|
72479702|NCT00717067|144485257|SUPERIORITY_OR_OTHER||ratio of adjusted geometric means|238.73||||||90.0|106.83|533.48|||ANOVA|||Ratio (%) test (severe) / reference (normal).||533.48|106.83|
72479703|NCT00717067|144485259|SUPERIORITY_OR_OTHER||ratio of adjusted geometric means|323.91||||||90.0|174.32|601.88|||ANOVA|||Ratio (%) test (severe) / reference (normal).||601.88|174.32|
72479704|NCT03536143|144485304|SUPERIORITY|||||||0.0216|||||||Log Rank|||||||0.0216
72479705|NCT03536143|144485305|SUPERIORITY|||||||0.0009|||||||Log Rank|||||||0.0009
72479706|NCT03406260|144485339|NON_INFERIORITY|A p-value \< 0.05 indicates lasmiditan can be declared noninferior to placebo with noninferiority margin of 10 mmHg, i.e. the difference lasmiditan mean minus placebo mean is less than 10 mmHg.|LS Mean Difference (Final Vaules)|-1.63|||<|0.0001|TWO_SIDED|95.0|-1000.0|1.81|||Linear Mixed Effects Model|||||1.81|-1000|<0.0001
72479707|NCT03406260|144485339|NON_INFERIORITY|A p-value \< 0.05 indicates lasmiditan can be declared noninferior to placebo with noninferiority margin of 10 mmHg, i.e. the difference lasmiditan mean minus placebo mean is less than 10 mmHg.|LS Mean Difference (Final Vaules)|-1.35|||<|0.0001|TWO_SIDED|95.0|-1000.0|2.06|||Linear Mixed Effects Model|||||2.06|-1000|<0.0001
72479708|NCT00871780|144485342|SUPERIORITY_OR_OTHER|||||||0.0003|||||||Wilcoxon signed rank test|||Baseline, Week 24||||0.0003
72479709|NCT00871780|144485342|SUPERIORITY_OR_OTHER|||||||0.0002|||||||Wilcoxon signed rank test|||Baseline, Week 48||||0.0002
72479710|NCT00871780|144485343|SUPERIORITY_OR_OTHER|||||||0.0148|||||||Wilcoxon signed rank test|||Baseline, Week 24||||0.0148
72479711|NCT00871780|144485343|SUPERIORITY_OR_OTHER|||||||0.0119|||||||Wilcoxon signed rank test|||Baseline, Week 48||||0.0119
72400520|NCT00975481|144308991|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|20.8096|||<|0.0001|TWO_SIDED|95.0|15.0866|26.5327|||Mixed Models Analysis|Mixed-effect model was implemented with Restricted Maximum Likelihood (REML) estimation method and Kenward-Roger degrees of freedom algorithm.||For Emax, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95 percent (%) Confidence Interval (CI) were obtained from the model.||26.5327|15.0866|<0.0001
72400521|NCT00975481|144308991|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|24.4625|||<|0.0001|TWO_SIDED|95.0|18.7321|30.1929|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emax, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||30.1929|18.7321|<0.0001
72400522|NCT00975481|144308991|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5792||||0.8428|TWO_SIDED|95.0|-6.3385|5.18|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emax, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||5.1800|-6.3385|0.8428
72400523|NCT00975481|144308991|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.9993||||0.4957|TWO_SIDED|95.0|-7.7832|3.7845|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emax, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||3.7845|-7.7832|0.4957
72400524|NCT00975481|144308991|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.9683||||0.7431|TWO_SIDED|95.0|-4.8567|6.7932|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emax, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||6.7932|-4.8567|0.7431
72400525|NCT00975481|144308991|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-21.3889|||<|0.0001|TWO_SIDED|95.0|-27.1044|-15.6734|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emax, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-15.6734|-27.1044|<0.0001
72479712|NCT00871780|144485344|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Wilcoxon signed rank test|||Baseline, Week 24||||<0.0001
72479713|NCT00871780|144485344|SUPERIORITY_OR_OTHER|||||||0.0157|TWO_SIDED||||||Wilcoxon signed rank test|||Baseline, Week 48||||0.0157
72479714|NCT00871780|144485345|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Wilcoxon signed rank test|||Baseline, Week 24||||<0.0001
72479715|NCT00871780|144485345|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Wilcoxon signed rank test|||Baseline, Week 48||||<0.0001
72479716|NCT00871780|144485346|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Pearson Correlation|||Baseline||||<0.0001
72479717|NCT00871780|144485346|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Pearson Correlation|||Change from Baseline at Week 24||||<0.0001
72509643|NCT03521154|144550014|SUPERIORITY||Hazard Ratio (HR)|0.17|||||TWO_SIDED|95.0|0.1|0.29|||Cox proportional hazard model||A hazard ratio \< 1 favours osimertinib|PFS in Ex19Del positive patients||0.29|0.10|
72479718|NCT00871780|144485346|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Pearson Correlation|||Change from Baseline at Week 48||||<0.0001
72509644|NCT03521154|144550014|SUPERIORITY||Hazard Ratio (HR)|0.32||||||95.0|0.19|0.56|||Cox proportional hazard model||A hazard ratio \< 1 favours osimertinib|PFS in L858R positive patients||0.56|0.19|
72509645|NCT03521154|144550015|SUPERIORITY||Hazard Ratio (HR)|0.22|||||TWO_SIDED|95.0|0.15|0.34|||Cox proportional hazard model||A hazard ratio \< 1 favours osimertinib|Negative at screening||0.34|0.15|
72479719|NCT00871780|144485347|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Spearman correlation|||Baseline||||<0.0001
72479720|NCT00871780|144485347|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Spearman correlation|||Change from Baseline at Week 24||||<0.0001
72479721|NCT00871780|144485347|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Spearman correlation|||Change from Baseline at Week 48||||<0.0001
72479722|NCT00871780|144485348|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Pearson Correlation|||Baseline||||<0.0001
72479723|NCT00871780|144485348|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Pearson Correlation|||Change from Baseline at Week 24||||<0.0001
72479724|NCT00871780|144485348|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Pearson Correlation|||Change from Baseline at Week 48||||<0.0001
72479725|NCT00871780|144485349|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Spearman correlation|||Baseline||||<0.0001
72479726|NCT00871780|144485349|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Spearman correlation|||Change from Baseline at Week 24||||<0.0001
72479727|NCT00871780|144485349|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Spearman correlation|||Change from Baseline at Week 48||||<0.0001
72479728|NCT00871780|144485350|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Pearson Correlation|||Baseline||||<0.0001
72479729|NCT00871780|144485350|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Pearson Correlation|||Change from Baseline at Week 24||||<0.0001
72479730|NCT00871780|144485350|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Pearson Correlation|||Change from Baseline at Week 48||||<0.0001
72479731|NCT00871780|144485351|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Spearman correlation|||Baseline||||<0.0001
72479732|NCT00871780|144485351|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Spearman correlation|||Change from Baseline at Week 24||||<0.0001
72479733|NCT00871780|144485351|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Spearman correlation|||Change from Baseline at Week 48||||<0.0001
72479734|NCT00871780|144485352|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Pearson Correlation|||Baseline||||<0.0001
72509646|NCT03521154|144550016|SUPERIORITY||Hazard Ratio (HR)|0.17|||<|0.001|TWO_SIDED|95.0|0.09|0.32|||Log Rank||A hazard ratio \< 1 favours osimertinib|||0.32|0.09|<0.001
72509647|NCT03521154|144550018|SUPERIORITY||Hazard Ratio (HR)|0.81||||0.53|TWO_SIDED|95.0|0.42|1.56|||Log Rank||A hazard ratio \< 1 favours osimertinib|||1.56|0.42|0.530
72509648|NCT03521154|144550019|SUPERIORITY||Odds Ratio (OR)|2.77|||<|0.001|TWO_SIDED|95.0|1.54|5.08|||Regression, Logistic||An odds ratio \> 1 favours osimertinib|||5.08|1.54|<0.001
72479735|NCT00871780|144485352|SUPERIORITY_OR_OTHER|||||||0.0016|TWO_SIDED||||||Pearson Correlation|||Change from Baseline at Week 24||||0.0016
72479736|NCT00871780|144485352|SUPERIORITY_OR_OTHER|||||||0.0866|TWO_SIDED||||||Pearson Correlation|||Change from Baseline at Week 48||||0.0866
72479737|NCT00871780|144485353|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Spearman correlation|||Baseline||||<0.0001
72479738|NCT00871780|144485353|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Spearman correlation|||Change from Baseline at Week 24||||<0.0001
72479739|NCT00871780|144485353|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Spearman correlation|||Change from Baseline at Week 48||||<0.0001
72479740|NCT00701220|144485356|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05|||||||ANOVA|||The data were analyzed using analysis of variance for repeated measures with two groups. The repeated measure was the proportion of circulating blood cells that were positive for aldehyde dehydrogenase using the commercially available Aldofluor assay. The two groups were those with ischemic and non-ischemic cardiomyopathy. This analysis permitted both intergroup and intragroup analysis of the change in aldehyde dehydrogenase positive cells.||||<0.05
72479741|NCT00440999|144485361|NON_INFERIORITY|The primary efficacy analysis tested the non-inferiority of the PA group compared to the comparator group with regard to the crude cure rate on Day 14 using the 2-sided 95% confidence interval (CI) (Newcombe-Wilson score method without continuity correction) and a 10% non-inferiority margin. Non-inferiority was claimed if the lower limit of the 2-sided 95% CI for the difference in cure rates on Day 14 was \>10%.|Difference in cure rate|-0.5|||||TWO_SIDED|95.0|-2.6|1.4|||||Conclusion: non-inferiority between PA \& chloroquine.|"Null hypothesis: The cure rate on Day 14 for the PA group is inferior to the cure rate on Day 14 for the chloroquine group by more than 10%.~Was tested against the alternative:~Alternative hypothesis: The cure rate on Day 14 for the PA group was not inferior to the cure rate on Day 14 for the chloroquine group by more than 10%."||1.4|-2.6|
72479742|NCT01205152|144485380|OTHER|||||||0.002||||||Two-sided with p-value threshold \<0.05 for statistical significance.|Wilcoxon signed-rank test|||Change is relative to Baseline in Study ENB-002-08 (NCT00744042). The RGI-C score represents evaluation of skeletal X-rays at each post-treatment study timepoint compared with pre-treatment X-rays from Study ENB-002-08 using an ordinal scale. Therefore, an RGI-C score is not applicable for radiographs obtained at Baseline.||||0.0020
72479743|NCT00116337|144485399|OTHER|Statistical analyses was performed using a repeated measures analysis of variance and Paired t test. A p value of \< 0.05 was taken as indicating statistical significance.|||||<|0.05|||||||ANOVA|Statistical analyses will be performed using a repeated measures analysis of variance and Paired t test.||Each patient was served as their own control; comparisons was made at various points in the study. Clinical parameters was assessed before the study and also at several end points following the Reconditioning Phase.||||<0.05
72479744|NCT00116337|144485401|OTHER||||||<|0.05|||||||nonparametric analog (Freidman Test)|||The data prior to implantation were compared with data obtained after implantation of the cough system using a nonparametric analog (Freidman Test) to the standard repeated measures analysis of variance. Statistical significance was assumed at P\<0.05. This alpha level was chosen as a correlation for inflated type I error rates because of multiple comparisons. Results are reported as means ± SEs.||||<0.05
72509649|NCT03521154|144550021|SUPERIORITY||Odds Ratio (OR)|2.06||||0.069|TWO_SIDED|95.0|0.94|4.47|||Regression, Logistic||An odds ratio \> 1 favours osimertinib.|||4.47|0.94|0.069
72509650|NCT03521154|144550024|SUPERIORITY||Hazard Ratio (HR)|0.21|||<|0.001|TWO_SIDED|95.0|0.11|0.38|||Log Rank||A hazard ratio \< 1 favours osimertinib|||0.38|0.11|<0.001
72509651|NCT03521154|144550025|SUPERIORITY||Hazard Ratio (HR)|0.21|||<|0.001|TWO_SIDED|95.0|0.14|0.32|||Log Rank||A hazard ratio \< 1 favours osimertinib|||0.32|0.14|<0.001
72509652|NCT03521154|144550026|SUPERIORITY||Hazard Ratio (HR)|0.13|||<|0.001|TWO_SIDED|95.0|0.08|0.21|||Log Rank||A hazard ratio \< 1 favours osimertinib|||0.21|0.08|<0.001
72509653|NCT03521154|144550027|SUPERIORITY||Hazard Ratio (HR)|0.51||||0.022|TWO_SIDED|95.0|0.28|0.91|||Log Rank||A hazard ratio \< 1 favours osimertinib|||0.91|0.28|0.022
72509654|NCT03521154|144550028|SUPERIORITY||Hazard Ratio (HR)|0.62||||0.088|TWO_SIDED|95.0|0.35|1.08|||Log Rank||A hazard ratio \< 1 favours osimertinib|||1.08|0.35|0.088
72509655|NCT04102098|144550095|SUPERIORITY||Hazard Ratio (HR)|0.72||||0.012|TWO_SIDED|95.0|0.56|0.93|||Log Rank|||Stratification factors include geographic region (Asia Pacific excluding Japan vs. rest of world) and High risk features/curative procedure (Ablation vs. Resection with 1 high risk feature vs. Resection with 2 or more high risk features).||0.93|0.56|0.0120
72509656|NCT04742907|144550107|SUPERIORITY||Cox Proportional Hazard|0.91||||0.767|TWO_SIDED|90.0|0.74|1.12||P-value is from the Wald Chi-Square statistic testing hypotheses of each dose of TU-100 compared with placebo: H0: hazard ratio (HR) = 1 vs. Ha: HR \> 1|Chi-squared||Hazard ratio and confidence intervals (CIs) are derived from a Cox proportional hazard model that includes main effects for treatment and surgical approach.|||1.12|0.74|0.767
72566605|NCT00773734|144663454|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|-2.2||||0.6541|TWO_SIDED|95.0|-11.7|7.3|||Chi-squared|||||7.3|-11.7|0.6541
72566606|NCT00773734|144663454|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|12.4||||0.0402|TWO_SIDED|95.0|0.6|24.1|||Chi-squared|||||24.1|0.6|0.0402
72479745|NCT02483585|144485425|SUPERIORITY|A sequential testing procedure, specifically, the hierarchical gate-keeping procedures and Hochberg method, was used to maintain the 2-sided study-wise type I error at 0.05 between the primary and efficacy secondary endpoints.|LS Mean Difference|-1.04|||<|0.001|TWO_SIDED|95.0|-1.61|-0.47|||Generalized Linear Mixed Model|||The primary endpoint was analyzed using a linear mixed effects model including treatment group, baseline value, stratification factors (region and prior/current treatment with migraine prophylactic medication), scheduled visit, and the interaction of treatment group with scheduled visit.||-0.47|-1.61|< 0.001
72479746|NCT02483585|144485426|SUPERIORITY||Odds Ratio (OR)|1.59||||0.01|TWO_SIDED|95.0|1.12|2.27|||Cochran-Mantel-Haenszel|||Analyzed using a Cochran-Mantel-Haenszel (CMH) test after the missing data were imputed as nonresponse, stratified by stratification factors (region and prior/current treatment with migraine prophylactic medication).||2.27|1.12|0.010
72479747|NCT02483585|144485427|SUPERIORITY||LS Mean Difference|-0.59||||0.002|TWO_SIDED|95.0|-0.96|-0.21|||Generalized Linear Mixed Model|||Analyzed using a linear mixed effects model including treatment group, baseline value, stratification factors (region and prior/current treatment with migraine prophylactic medication), scheduled visit, and the interaction of treatment group with scheduled visit.||-0.21|-0.96|0.002
72479748|NCT02483585|144485428|SUPERIORITY||Odds Ratio (OR)|1.22||||0.26|TWO_SIDED|95.0|0.87|1.71|||Cochran-Mantel-Haenszel|||Analyzed using a Cochran-Mantel-Haenszel (CMH) test after the missing data were imputed as nonresponse, stratified by stratification factors (region and prior/current treatment with migraine prophylactic medication).||1.71|0.87|0.26
72479749|NCT02483585|144485429|SUPERIORITY||Odds Ratio (OR)|1.33||||0.13|TWO_SIDED|95.0|0.92|1.9|||Cochran-Mantel-Haenszel|||Analyzed using a Cochran-Mantel-Haenszel (CMH) test after the missing data were imputed as nonresponse, stratified by stratification factors (region and prior/current treatment with migraine prophylactic medication).||1.90|0.92|0.13
72479750|NCT00912301|144485436|SUPERIORITY_OR_OTHER|||||||0.031||95.0|||||Dunnett's test|pairwise comparison low dose NaCDC against placebo||||||0.031
72509657|NCT04742907|144550107|SUPERIORITY||Cox Proportional Hazard|1.17||||0.107|TWO_SIDED|90.0|0.95|1.44||P-value is from the Wald Chi-Square statistic testing hypotheses of each dose of TU-100 compared with placebo: H0: HR = 1 vs. Ha: HR \> 1|Chi-squared||Hazard ratio and CIs are derived from a Cox proportional hazard model that includes main effects for treatment and surgical approach.|||1.44|0.95|0.107
72509658|NCT04742907|144550108|SUPERIORITY||Cox Proportional Hazard|0.9||||0.78|TWO_SIDED|90.0|0.71|1.13||P-value is from the Wald Chi-Square statistic testing hypotheses of each dose of TU-100 compared with placebo: H0: HR = 1 vs. Ha: HR \> 1|Chi-squared||Hazard ratio and CIs are derived from a Cox proportional hazard model that includes main effects for treatment and surgical approach.|For Time to GI-2||1.13|0.71|0.780
72566607|NCT00773734|144663454|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|21.1||||0.0011|TWO_SIDED|95.0|8.8|33.4|||Chi-squared|||||33.4|8.8|0.0011
72566608|NCT00773734|144663458|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-20.2||||0.002|TWO_SIDED|95.0|-33.0|-7.5|||ANCOVA|Based on an analysis of covariance model with treatment group as a factor and the baseline value as a covariate||||-7.5|-33.0|0.0020
72566609|NCT00773734|144663458|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-29.9|||<|0.0001|TWO_SIDED|95.0|-42.9|-17.0|||ANCOVA|based on an analysis of covariance model with treatment group as a factor and the baseline value as a covariate||||-17.0|-42.9|<0.0001
72566610|NCT00773734|144663458|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-42.4|||<|0.0001|TWO_SIDED|95.0|-55.2|-29.5||Based on an analysis of covariance model with treatment group as a factor and the baseline value as a covariate|ANCOVA|||||-29.5|-55.2|<0.0001
72566611|NCT00773734|144663460|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-1.3||||0.1322|TWO_SIDED|95.0|-3.1|0.4|||ANCOVA|Based on an analysis of covariance model with treatment group as a factor and the baseline value as a covariate.||||0.4|-3.1|0.1322
72566612|NCT00773734|144663460|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-4.1|||<|0.0001|TWO_SIDED|95.0|-5.9|-2.3|||ANCOVA|Based on an analysis of covariance model with treatment group as a factor and the baseline value as a covariate.||||-2.3|-5.9|<0.0001
72566613|NCT00773734|144663460|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-2.6||||0.0047|TWO_SIDED|95.0|-4.3|-0.8|||ANCOVA|Based on an analysis of covariance model with treatment group as a factor and the baseline value as a covariate.||||-0.8|-4.3|0.0047
72479751|NCT00912301|144485436|SUPERIORITY_OR_OTHER|||||||0.01||95.0|||||Dunnett's test|pairwise comparison high dose NaCDC against placebo||||||0.010
72479752|NCT01959516|144485469|SUPERIORITY_OR_OTHER|||||||0.025|||||||Mixed Models Analysis|||||||0.0250
72479753|NCT01959516|144485470|SUPERIORITY_OR_OTHER|||||||0.1439|||||||Mixed Models Analysis|||||||0.1439
72479754|NCT00819390|144485528|SUPERIORITY_OR_OTHER|||||||0.428||||||The p-value is not adjusted for multiple comparisons. The a priori threshold for statistical significance used for the two-sided test was 0.05.|Wilcoxon (Mann-Whitney)|No other adjustments||Null hypothesis: There is no difference between the two arms/groups with respect to change in percent CD8 HLA-DR+/CD38+ from baseline to week 12.||||0.428
72479755|NCT00819390|144485528|SUPERIORITY_OR_OTHER|||||||0.247||||||The p-value is not adjusted for multiple comparisons. The a priori threshold for statistical significance used for the two-sided test was 0.05.|Wilcoxon (Mann-Whitney)|No other adjustments.||Null hypothesis: There is no difference between the two arms/groups with respect to change in percent CD8 HLA-DR+/CD38+ from baseline to week 12.||||0.247
72479756|NCT01270971|144485558|SUPERIORITY_OR_OTHER|||||||0.001|||||||Cochran-Mantel-Haenszel|||||||0.001
72479757|NCT01270971|144485559|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
72479758|NCT01270971|144485560|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
72509659|NCT04742907|144550108|SUPERIORITY||Cox Proportional Hazard|1.06||||0.33|TWO_SIDED|90.0|0.84|1.34||P-value is from the Wald Chi-Square statistic testing hypotheses of each dose of TU-100 compared with placebo: H0: HR = 1 vs. Ha: HR \> 1|Chi-squared||Hazard ratio and CIs are derived from a Cox proportional hazard model that includes main effects for treatment and surgical approach.|For Time to GI-2||1.34|0.84|0.330
72509660|NCT04742907|144550108|SUPERIORITY||Cox Proportional Hazard|0.9||||0.788|TWO_SIDED|90.0|0.73|1.11||P-value is from the Wald Chi-Square statistic testing hypotheses of each dose of TU-100 compared with placebo: H0: HR = 1 vs. Ha: HR \> 1|Chi-squared||Hazard ratio and CIs are derived from a Cox proportional hazard model that includes main effects for treatment and surgical approach.|For Time to first toleration of clear liquids||1.11|0.73|0.788
72479759|NCT01270971|144485561|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
72479760|NCT01242800|144485567|SUPERIORITY|||||||0.32|||||||Log Rank|Stratified log rank test was used for arm comparison||||||0.32
72479761|NCT02640157|144485572|NON_INFERIORITY|Noninferiority: a) the lower bound (LB) of the 95%CI for the difference was above the non-inferiority margin of -6% and the LB of the 95%CI for the SVR12 rate within Arm A was \>92%; or b) the LB of the 95%CI for the difference was below the non-inferiority margin of -6% and the LB of the 97.5%CI for the SVR12 rate within Arm A was \>92%; or c) the LB of the 97.5%CI for the difference was above the non-inferiority margin of -6% and the LB of the 95%CI for the SVR12 rate within Arm A was below 92%.|Difference in percentage of participants|-1.2|||||TWO_SIDED|95.0|-5.6|3.1||||||Difference in SVR12 rates (Arm A - Arm B).||3.1|-5.6|
72479762|NCT02640157|144485572|NON_INFERIORITY|Noninferiority: a) the lower bound (LB) of the 95%CI for the difference was above the non-inferiority margin of -6% and the LB of the 95%CI for the SVR12 rate within Arm A was \>92%; or b) the LB of the 95%CI for the difference was below the non-inferiority margin of -6% and the LB of the 97.5%CI for the SVR12 rate within Arm A was \>92%; or c) the LB of the 97.5%CI for the difference was above the non-inferiority margin of -6% and the LB of the 95%CI for the SVR12 rate within Arm A was below 92%.|percentage of participants|95.3|||||TWO_SIDED|97.5|92.2|98.4||||||||98.4|92.2|
72509661|NCT04742907|144550108|SUPERIORITY||Cox Proportional Hazard|1.22||||0.055|TWO_SIDED|90.0|0.99|1.51||P-value is from the Wald Chi-Square statistic testing hypotheses of each dose of TU-100 compared with placebo: H0: HR = 1 vs. Ha: HR \> 1|Chi-squared||Hazard ratio and CIs are derived from a Cox proportional hazard model that includes main effects for treatment and surgical approach.|For Time to first toleration of clear liquids||1.51|0.99|0.055
72509662|NCT04742907|144550108|SUPERIORITY||Cox Proportional Hazard|1.07||||0.306|TWO_SIDED|90.0|0.86|1.32||P-value is from the Wald Chi-Square statistic testing hypotheses of each dose of TU-100 compared with placebo: H0: HR = 1 vs. Ha: HR \> 1|Chi-squared||Hazard ratio and CIs are derived from a Cox proportional hazard model that includes main effects for treatment and surgical approach.|For Time to absence of distension and presence of bowel sounds and flatus||1.32|0.86|0.306
72509663|NCT04742907|144550108|SUPERIORITY||Cox Proportional Hazard|1.09||||0.243|TWO_SIDED|90.0|0.88|1.35||P-value is from the Wald Chi-Square statistic testing hypotheses of each dose of TU-100 compared with placebo: H0: HR = 1 vs. Ha: HR \> 1|Chi-squared||Hazard ratio and CIs are derived from a Cox proportional hazard model that includes main effects for treatment and surgical approach.|For Time to absence of distension and presence of bowel sounds and flatus||1.35|0.88|0.243
72566614|NCT00773734|144663462|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|3.3||||0.0078|TWO_SIDED|95.0|0.9|5.8|||ANCOVA|Based on an analysis of covariance model with treatment group as a factor and the baseline value as a covariate.||||5.8|0.9|0.0078
72566615|NCT00773734|144663462|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|3.5||||0.0068|TWO_SIDED|95.0|1.0|6.0|||ANCOVA|Based on an analysis of covariance model with treatment group as a factor and the baseline value as a covariate.||||6.0|1.0|0.0068
72566616|NCT00773734|144663462|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|3.6||||0.0045|TWO_SIDED|95.0|1.1|6.1|||ANCOVA|Based on an analysis of covariance model with treatment group as a factor and the baseline value as a covariate.||||6.1|1.1|0.0045
72566617|NCT00773734|144663463|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|0.6||||0.6097|TWO_SIDED|95.0|-1.6|2.8|||ANCOVA|Based on an analysis of covariance model with treatment group as a factor and the baseline value as a covariate.||||2.8|-1.6|0.6097
72566618|NCT00773734|144663463|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|1.3||||0.2424|TWO_SIDED|95.0|-0.9|3.6|||ANCOVA|Based on an analysis of covariance model with treatment group as a factor and the baseline value as a covariate.||||3.6|-0.9|0.2424
72566619|NCT00773734|144663463|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|0.1||||0.9528|TWO_SIDED|95.0|-2.2|2.3|||ANCOVA|Based on an analysis of covariance model with treatment group as a factor and the baseline value as a covariate.||||2.3|-2.2|0.9528
72566620|NCT01659736|144663561|SUPERIORITY_OR_OTHER|||||||0.006|TWO_SIDED|||||p-value is for the condition (active TMS versus Sham) by time (pre, post, 3-month follow-up) interaction|ANOVA|||||||0.006
72566621|NCT00391079|144663566|SUPERIORITY_OR_OTHER||Estimated treatment effect|-0.17||||0.468|TWO_SIDED|95.0|-0.62|0.29|||ANCOVA|||The change in pain NRS score from baseline to the end of study was analyzed using analysis of covariance (ANCOVA) with the baseline value as a covariate and centre group and treatment as factors.||0.29|-0.62|0.468
72566622|NCT00391079|144663567|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.309||||0.2338|TWO_SIDED|95.0|0.84|2.038|||Regression, Logistic|||The proportions of responders were compared between the treatment groups using logistic regression with region and treatment groups as factors. The null hypothesis was that there was no difference between each Sativex and placebo.||2.038|0.840|0.2338
72566623|NCT00391079|144663568|SUPERIORITY_OR_OTHER||Estimated treatment effect|-1.83||||0.3103|TWO_SIDED|95.0|-5.39|1.72|||ANOVA||A negative difference in estimated treatment effect indicates an improvement in pain in favour of Sativex.|The change in NPS score from baseline to the end of study was analyzed using analysis of covariance (ANCOVA) with the baseline value as a covariate and centre group and treatment as factors.||1.72|-5.39|0.3103
72566624|NCT00391079|144663569|SUPERIORITY_OR_OTHER||Estimated treatment difference|-0.24||||0.1567|TWO_SIDED|95.0|-0.57|0.09|||ANCOVA||A negative difference in estimated treatment difference indicates a reduction in breakthrough analgesic medication in favour of Sativex.|The change in average number of tablets taken daily from baseline to the end of study was analyzed using analysis of covariance (ANCOVA) with the baseline value as a covariate and centre group and treatment as factors.||0.09|-0.57|0.1567
72566625|NCT00391079|144663570|SUPERIORITY_OR_OTHER||Estimated treatment difference|-0.12||||0.5643|TWO_SIDED|95.0|-0.53|0.29|||ANCOVA||A negative difference in estimated means indicates an improvement in pain in favour of Sativex.|||0.29|-0.53|0.5643
72566626|NCT00391079|144663571|SUPERIORITY_OR_OTHER||Odds Ratio, log|1.47||||0.0552|TWO_SIDED|95.0|0.991|2.179|||Regression, Logistic||An odds ratio of greater than 1 indicates and improvement in favour of Sativex.|||2.179|0.991|0.0552
72400526|NCT00975481|144308991|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-22.809|||<|0.0001|TWO_SIDED|95.0|-28.5584|-17.0596|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emax, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-17.0596|-28.5584|<0.0001
72479763|NCT02640157|144485572|NON_INFERIORITY|Noninferiority: a) the lower bound (LB) of the 95%CI for the difference was above the non-inferiority margin of -6% and the LB of the 95%CI for the SVR12 rate within Arm A was \>92%; or b) the LB of the 95%CI for the difference was below the non-inferiority margin of -6% and the LB of the 97.5%CI for the SVR12 rate within Arm A was \>92%; or c) the LB of the 97.5%CI for the difference was above the non-inferiority margin of -6% and the LB of the 95%CI for the SVR12 rate within Arm A was below 92%.|Difference in percentage of participants|-1.2|||||TWO_SIDED|97.5|-6.2|3.7||||||Difference in SVR12 rates (Arm A - Arm B).||3.7|-6.2|
72479764|NCT02640157|144485573|NON_INFERIORITY|Noninferiority: a) the lower bound (LB) of the 95%CI for the difference was above the non-inferiority margin of -6% and the LB of the 95%CI for the SVR12 rate within Arm C was \>92%; or b) the LB of the 95%CI for the difference was below the non-inferiority margin of -6% and the LB of the 97.5%CI for the SVR12 rate within Arm C was \>92%; or c) the LB of the 97.5%CI for the difference was above the non-inferiority margin of -6% and the LB of the 95%CI for the SVR12 rate within Arm C was below 92%.|Difference in percentage of participants|-0.4|||||TWO_SIDED|95.0|-4.8|4.0||||||Difference in SVR12 rates (Arm C - Arm A)||4.0|-4.8|
72479765|NCT02640157|144485573|NON_INFERIORITY|Noninferiority: a) the lower bound (LB) of the 95%CI for the difference was above the non-inferiority margin of -6% and the LB of the 95%CI for the SVR12 rate within Arm C was \>92%; or b) the LB of the 95%CI for the difference was below the non-inferiority margin of -6% and the LB of the 97.5%CI for the SVR12 rate within Arm C was \>92%; or c) the LB of the 97.5%CI for the difference was above the non-inferiority margin of -6% and the LB of the 95%CI for the SVR12 rate within Arm C was below 92%.|Percentage of participants|94.9|||||TWO_SIDED|97.5|91.0|98.8||||||||98.8|91.0|
72479766|NCT02640157|144485573|NON_INFERIORITY|Noninferiority: a) the lower bound (LB) of the 95%CI for the difference was above the non-inferiority margin of -6% and the LB of the 95%CI for the SVR12 rate within Arm C was \>92%; or b) the LB of the 95%CI for the difference was below the non-inferiority margin of -6% and the LB of the 97.5%CI for the SVR12 rate within Arm C was \>92%; or c) the LB of the 97.5%CI for the difference was above the non-inferiority margin of -6% and the LB of the 95%CI for the SVR12 rate within Arm C was below 92%.|Difference in percentage of participants|-0.4|||||TWO_SIDED|97.5|-5.4|4.6||||||||4.6|-5.4|
72479767|NCT04677179|144485586|SUPERIORITY||Odds Ratio (OR)|0.57||||0.75|TWO_SIDED|95.0|0.03|11.32|||Cochran-Mantel-Haenszel|||||11.32|0.03|0.750
72509664|NCT04742907|144550109|SUPERIORITY||Cox Proportional Hazard|1.0||||0.489|TWO_SIDED|90.0|0.81|1.24||P-value is from the Wald Chi-Square statistic testing hypotheses of each dose of TU-100 compared with placebo: H0: HR = 1 vs. Ha: HR \> 1|Chi-squared||Hazard ratio and CIs are derived from a Cox proportional hazard model that includes main effects for treatment and surgical approach.|For Time to ready for discharge||1.24|0.81|0.489
72479768|NCT04677179|144485586|SUPERIORITY||Odds Ratio (OR)|0.8||||0.838|TWO_SIDED|95.0|0.1|6.21|||Cochran-Mantel-Haenszel|||||6.21|0.10|0.838
72479769|NCT04677179|144485587|SUPERIORITY||Odds Ratio (OR)|0.57||||0.563|TWO_SIDED|95.0|0.1|3.3|||Cochran-Mantel-Haenszel|||||3.30|0.10|0.563
72479770|NCT04677179|144485587|SUPERIORITY||Odds Ratio (OR)|0.78||||0.759|TWO_SIDED|95.0|0.17|3.64|||Cochran-Mantel-Haenszel|||||3.64|0.17|0.759
72509665|NCT04742907|144550109|SUPERIORITY||Cox Proportional Hazard|1.15||||0.138|TWO_SIDED|90.0|0.93|1.42||P-value is from the Wald Chi-Square statistic testing hypotheses of each dose of TU-100 compared with placebo: H0: HR = 1 vs. Ha: HR \> 1|Chi-squared||Hazard ratio and CIs are derived from a Cox proportional hazard model that includes main effects for treatment and surgical approach.|For Time to ready for discharge||1.42|0.93|0.138
72509666|NCT04742907|144550109|SUPERIORITY||Cox Proportional Hazard|1.01||||0.473|TWO_SIDED|90.0|0.82|1.24||P-value is from the Wald Chi-Square statistic testing hypotheses of each dose of TU-100 compared with placebo: H0: HR = 1 vs. Ha: HR \> 1|Chi-squared||Hazard ratio and CIs are derived from a Cox proportional hazard model that includes main effects for treatment and surgical approach.|For Time to discharge order written||1.24|0.82|0.473
72509667|NCT04742907|144550109|SUPERIORITY||Cox Proportional Hazard|1.24||||0.045|TWO_SIDED|90.0|1.01|1.53||P-value is from the Wald Chi-Square statistic testing hypotheses of each dose of TU-100 compared with placebo: H0: HR = 1 vs. Ha: HR \> 1|Chi-squared||Hazard ratio and CIs are derived from a Cox proportional hazard model that includes main effects for treatment and surgical approach.|For Time to discharge order written||1.53|1.01|0.045
72509668|NCT04742907|144550110|SUPERIORITY|||||||0.923||||||P-value is from two-sample t-test comparing TU-100 15 g/day treatment group versus placebo.|t-test, 2 sided|||||||0.923
72509669|NCT04742907|144550110|SUPERIORITY|||||||0.039||||||P-value is from two-sample t-test comparing TU-100 7.5 g/day treatment group versus placebo.|t-test, 2 sided|||||||0.039
72566627|NCT00391079|144663572|SUPERIORITY_OR_OTHER||estimated treatment difference|0.05||||0.833|TWO_SIDED|95.0|-0.39|0.48|||ANCOVA||A negative difference in estimated treatment difference indicates an improvement in sleep quality in favour of Sativex.|||0.48|-0.39|0.8330
72479771|NCT04677179|144485588|SUPERIORITY||Odds Ratio (OR)|0.18||||0.163|TWO_SIDED|95.0|0.02|1.93|||Cochran-Mantel-Haenszel|||||1.93|0.02|0.163
72479772|NCT04677179|144485588|SUPERIORITY||Odds Ratio (OR)|0.54||||0.439|TWO_SIDED|95.0|0.11|2.77|||Cochran-Mantel-Haenszel|||||2.77|0.11|0.439
72509670|NCT04742907|144550112|SUPERIORITY||Odds Ratio (OR)|0.79||||0.434|TWO_SIDED|95.0|0.44|1.42||p value is assessing the null hypothesis that the odds ratio is equal to 1.|Regression, Logistic||Responder status is analyzed using logistic regression with GIR response as the dependent variable; treatment and surgical approach (open, laparoscopic) as covariates.|For Day 1||1.42|0.44|0.434
72509671|NCT04742907|144550112|SUPERIORITY||Odds Ratio (OR)|0.9||||0.71|TWO_SIDED|95.0|0.51|1.59||p value is assessing the null hypothesis that the odds ratio is equal to 1.|Regression, Logistic||Responder status is analyzed using logistic regression with GIR response as the dependent variable; treatment and surgical approach (open, laparoscopic) as covariates.|For Day 1||1.59|0.51|0.710
72509672|NCT04742907|144550112|SUPERIORITY||Odds Ratio (OR)|1.23||||0.41|TWO_SIDED|95.0|0.75|2.02||p value is assessing the null hypothesis that the odds ratio is equal to 1.|Chi-squared||Responder status is analyzed using logistic regression with GIR response as the dependent variable; treatment and surgical approach (open, laparoscopic) as covariates.|For Day 2||2.02|0.75|0.410
72509673|NCT04742907|144550112|SUPERIORITY||Odds Ratio (OR)|1.7||||0.037|TWO_SIDED|95.0|1.03|2.81||p value is assessing the null hypothesis that the odds ratio is equal to 1.|Regression, Logistic||Responder status is analyzed using logistic regression with GIR response as the dependent variable; treatment and surgical approach (open, laparoscopic) as covariates.|For Day 2||2.81|1.03|0.037
72509674|NCT04742907|144550112|SUPERIORITY||Odds Ratio (OR)|0.84||||0.579|TWO_SIDED|95.0|0.46|1.55||p value is assessing the null hypothesis that the odds ratio is equal to 1.|Regression, Logistic||Responder status is analyzed using logistic regression with GIR response as the dependent variable; treatment and surgical approach (open, laparoscopic) as covariates.|For Day 3||1.55|0.46|0.579
72509675|NCT04742907|144550112|SUPERIORITY||Odds Ratio (OR)|0.63||||0.167|TWO_SIDED|95.0|0.33|1.21||p value is assessing the null hypothesis that the odds ratio is equal to 1.|Regression, Logistic|||For Day 3||1.21|0.33|0.167
72509676|NCT04742907|144550112|SUPERIORITY||Odds Ratio (OR)|0.63||||0.4|TWO_SIDED|95.0|0.21|1.86||p value is assessing the null hypothesis that the odds ratio is equal to 1.|Regression, Logistic||Responder status is analyzed using logistic regression with GIR response as the dependent variable; treatment and surgical approach (open, laparoscopic) as covariates.|For Day 4||1.86|0.21|0.400
72509677|NCT04742907|144550112|SUPERIORITY||Odds Ratio (OR)|0.28||||0.083|TWO_SIDED|95.0|0.07|1.18|||Regression, Logistic||Responder status is analyzed using logistic regression with GIR response as the dependent variable; treatment and surgical approach (open, laparoscopic) as covariates.|For Day 4||1.18|0.07|0.083
72509678|NCT04742907|144550113|SUPERIORITY||Odds Ratio (OR)|1.33||||0.621|TWO_SIDED|95.0|0.43|4.14||p value is assessing the null hypothesis that the odds ratio is equal to 1.|Regression, Logistic||POI-related Morbidity status is analyzed using logistic regression with POI-related morbidity as the dependent variable; treatment and surgical approach (open, laparoscopic) as covariates.|||4.14|0.43|0.621
72509679|NCT04742907|144550113|SUPERIORITY||Odds Ratio (OR)|1.03||||0.962|TWO_SIDED|95.0|0.31|3.46||p value is assessing the null hypothesis that the odds ratio is equal to 1.|Regression, Logistic||POI-related Morbidity status is analyzed using logistic regression with POI-related morbidity as the dependent variable; treatment and surgical approach (open, laparoscopic) as covariates.|||3.46|0.31|0.962
72509680|NCT04742907|144550115|SUPERIORITY||Odds Ratio (OR)|1.16||||0.604|TWO_SIDED|95.0|0.66|2.05||p value is assessing the null hypothesis that the odds ratio is equal to 1.|Regression, Logistic||Subject-reported (eDiary) - Nausea status is analyzed using logistic regression with Subject-reported (eDiary) - Nausea as the dependent variable; treatment and surgical approach (open, laparoscopic) as covariates.|For Day 1||2.05|0.66|0.604
72509681|NCT04742907|144550115|SUPERIORITY||Odds Ratio (OR)|1.12||||0.693|TWO_SIDED|95.0|0.63|1.99||p value is assessing the null hypothesis that the odds ratio is equal to 1.|Regression, Logistic||Subject-reported (eDiary) - Nausea status is analyzed using logistic regression with Subject-reported (eDiary) - Nausea as the dependent variable; treatment and surgical approach (open, laparoscopic) as covariates.|For Day 1||1.99|0.63|0.693
72509682|NCT04742907|144550115|SUPERIORITY||Odds Ratio (OR)|1.8||||0.122|TWO_SIDED|95.0|0.85|3.78||p value is assessing the null hypothesis that the odds ratio is equal to 1.|Regression, Logistic||Subject-reported (eDiary) - Nausea status is analyzed using logistic regression with Subject-reported (eDiary) - Nausea as the dependent variable; treatment and surgical approach (open, laparoscopic) as covariates.|For Day 2||3.78|0.85|0.122
72509683|NCT04742907|144550115|SUPERIORITY||Odds Ratio (OR)|0.78||||0.518|TWO_SIDED|95.0|0.36|1.67||p value is assessing the null hypothesis that the odds ratio is equal to 1.|Regression, Logistic||Subject-reported (eDiary) - Nausea status is analyzed using logistic regression with Subject-reported (eDiary) - Nausea as the dependent variable; treatment and surgical approach (open, laparoscopic) as covariates.|For Day 2||1.67|0.36|0.518
72509684|NCT04742907|144550115|SUPERIORITY||Odds Ratio (OR)|1.45||||0.528|TWO_SIDED|95.0|0.46|4.53||p value is assessing the null hypothesis that the odds ratio is equal to 1.|Regression, Logistic||Subject-reported (eDiary) - Nausea status is analyzed using logistic regression with Subject-reported (eDiary) - Nausea as the dependent variable; treatment and surgical approach (open, laparoscopic) as covariates.|For Day 3||4.53|0.46|0.528
72509685|NCT04742907|144550115|SUPERIORITY||Odds Ratio (OR)|1.27||||0.689|TWO_SIDED|95.0|0.4|4.07||p value is assessing the null hypothesis that the odds ratio is equal to 1.|Regression, Logistic||Subject-reported (eDiary) - Nausea status is analyzed using logistic regression with Subject-reported (eDiary) - Nausea as the dependent variable; treatment and surgical approach (open, laparoscopic) as covariates.|For Day 3||4.07|0.40|0.689
72509686|NCT04742907|144550115|SUPERIORITY||Odds Ratio (OR)|0.68||||0.653|TWO_SIDED|95.0|0.12|3.7||p value is assessing the null hypothesis that the odds ratio is equal to 1.|Regression, Logistic||Subject-reported (eDiary) - Nausea status is analyzed using logistic regression with Subject-reported (eDiary) - Nausea as the dependent variable; treatment and surgical approach (open, laparoscopic) as covariates.|For Day 4||3.70|0.12|0.653
72509687|NCT04742907|144550115|SUPERIORITY||Odds Ratio (OR)|1.85||||0.452|TWO_SIDED|95.0|0.37|9.25||p value is assessing the null hypothesis that the odds ratio is equal to 1.|Regression, Logistic||Subject-reported (eDiary) - Nausea status is analyzed using logistic regression with Subject-reported (eDiary) - Nausea as the dependent variable; treatment and surgical approach (open, laparoscopic) as covariates.|For Day 4||9.25|0.37|0.452
72400527|NCT00975481|144308991|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-19.8414|||<|0.0001|TWO_SIDED|95.0|-25.6435|-14.0393|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emax, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-14.0393|-25.6435|<0.0001
72479773|NCT04677179|144485589|SUPERIORITY||Odds Ratio (OR)|1.29||||0.821|TWO_SIDED|95.0|0.17|9.88|||Cochran-Mantel-Haenszel|||||9.88|0.17|0.821
72479774|NCT04677179|144485589|SUPERIORITY||Odds Ratio (OR)|1.43||||0.572|TWO_SIDED|95.0|0.37|5.49|||Cochran-Mantel-Haenszel|||||5.49|0.37|0.572
72509688|NCT04742907|144550116|SUPERIORITY||Mean Difference (Final Values)|-0.6||||0.359|TWO_SIDED|95.0|-1.8|0.6|||Mixed Models Analysis|||For Day 1, least square (LS) mean difference between placebo and TU-100 15 g/day. Mixed Model Repeated Measures approach was used to assess the bothersomeness of Nausea as the dependent variable and treatment group, surgical approach and treatment group by visit as covariates. An unstructured covariance structure is used to model the within-subject errors, shared across treatments.||0.6|-1.8|0.359
72509689|NCT04742907|144550116|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.907|TWO_SIDED|95.0|-1.3|1.2|||Mixed Models Analysis|||For Day 1, LS mean difference between placebo and TU-100 7.5 g/day. Mixed Model Repeated Measures approach was used to assess the bothersomeness of Nausea as the dependent variable and treatment group, surgical approach and treatment group by visit as covariates. An unstructured covariance structure is used to model the within-subject errors, shared across treatments.||1.2|-1.3|0.907
72509690|NCT04742907|144550116|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.856|TWO_SIDED|95.0|-1.3|1.6|||Mixed Models Analysis|||For Day 2, LS mean difference between placebo and TU-100 15 g/day. Mixed Model Repeated Measures approach was used to assess the bothersomeness of Nausea as the dependent variable and treatment group, surgical approach and treatment group by visit as covariates. An unstructured covariance structure is used to model the within-subject errors, shared across treatments.||1.6|-1.3|0.856
72509691|NCT04742907|144550116|SUPERIORITY||Mean Difference (Final Values)|-1.1||||0.18|TWO_SIDED|95.0|-2.7|0.5|||Mixed Models Analysis|||For Day 2, LS mean difference between placebo and TU-100 7.5 g/day. Mixed Model Repeated Measures approach was used to assess the bothersomeness of Nausea as the dependent variable and treatment group, surgical approach and treatment group by visit as covariates. An unstructured covariance structure is used to model the within-subject errors, shared across treatments.||0.5|-2.7|0.180
72400528|NCT00975481|144308991|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-25.0418|||<|0.0001|TWO_SIDED|95.0|-30.6705|-19.413|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emax, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-19.4130|-30.6705|<0.0001
72479775|NCT04677179|144485590|SUPERIORITY||Odds Ratio (OR)|1.18||||0.886|TWO_SIDED|95.0|0.14|10.16|||Cochran-Mantel-Haenszel|||||10.16|0.14|0.886
72479776|NCT04677179|144485590|SUPERIORITY||Odds Ratio (OR)|0.78||||0.784|TWO_SIDED|95.0|0.14|4.18|||Cochran-Mantel-Haenszel|||||4.18|0.14|0.784
72479777|NCT04677179|144485591|SUPERIORITY||Odds Ratio (OR)|0.37||||0.331|TWO_SIDED|95.0|0.06|2.43|||Cochran-Mantel-Haenszel|||||2.43|0.06|0.331
72479778|NCT04677179|144485591|SUPERIORITY||Odds Ratio (OR)|0.51||||0.407|TWO_SIDED|95.0|0.1|2.52|||Cochran-Mantel-Haenszel|||||2.52|0.10|0.407
72479779|NCT04677179|144485592|SUPERIORITY||Risk Ratio (RR)|1.5||||0.564|TWO_SIDED|95.0|0.38|6.0|||Cochran-Mantel-Haenszel|||||6.00|0.38|0.564
72479780|NCT04677179|144485592|SUPERIORITY||Risk Ratio (RR)|1.51||||0.681|TWO_SIDED|95.0|0.21|10.97|||Cochran-Mantel-Haenszel|||||10.97|0.21|0.681
72479781|NCT04677179|144485593|SUPERIORITY||Risk Difference (RD)|3.6||||0.317|TWO_SIDED|95.0|-3.3|10.4|||Cochran-Mantel-Haenszel|||||10.4|-3.3|0.317
72479782|NCT04677179|144485593|SUPERIORITY||Risk Difference (RD)|6.9||||0.238|TWO_SIDED|95.0|-2.3|16.1|||Cochran-Mantel-Haenszel|||||16.1|-2.3|0.238
72509692|NCT04742907|144550116|SUPERIORITY||Mean Difference (Final Values)|0.3||||0.814|TWO_SIDED|95.0|-1.9|2.4|||Mixed Models Analysis|||For Day 3, LS mean difference between placebo and TU-100 15 g/day. Mixed Model Repeated Measures approach was used to assess the bothersomeness of Nausea as the dependent variable and treatment group, surgical approach and treatment group by visit as covariates. An unstructured covariance structure is used to model the within-subject errors, shared across treatments.||2.4|-1.9|0.814
72509693|NCT04742907|144550116|SUPERIORITY||Mean Difference (Final Values)|-1.0||||0.409|TWO_SIDED|95.0|-3.2|1.3|||Mixed Models Analysis|||For Day 3, LS mean difference between placebo and TU-100 7.5 g/day. Mixed Model Repeated Measures approach was used to assess the bothersomeness of Nausea as the dependent variable and treatment group, surgical approach and treatment group by visit as covariates. An unstructured covariance structure is used to model the within-subject errors, shared across treatments.||1.3|-3.2|0.409
72509694|NCT04742907|144550117|SUPERIORITY||Odds Ratio (OR)|0.8||||0.43|TWO_SIDED|95.0|0.46|1.4||p value is assessing the null hypothesis that the odds ratio is equal to 1.|Regression, Logistic||Subject-reported (eDiary) - Abdominal Bloating status is analyzed using logistic regression with Subject-reported (eDiary) - Abdominal Bloating as the dependent variable; treatment and surgical approach (open, laparoscopic) as covariates.|For Day 1||1.40|0.46|0.430
72509695|NCT04742907|144550117|SUPERIORITY||Odds Ratio (OR)|1.1||||0.739|TWO_SIDED|95.0|0.62|1.96||p value is assessing the null hypothesis that the odds ratio is equal to 1.|Regression, Logistic||Subject-reported (eDiary) - Abdominal Bloating status is analyzed using logistic regression with Subject-reported (eDiary) - Abdominal Bloating as the dependent variable; treatment and surgical approach (open, laparoscopic) as covariates.|For Day 1||1.96|0.62|0.739
72509696|NCT04742907|144550117|SUPERIORITY||Odds Ratio (OR)|0.54||||0.13|TWO_SIDED|95.0|0.25|1.2||p value is assessing the null hypothesis that the odds ratio is equal to 1.|Regression, Logistic||Subject-reported (eDiary) - Abdominal Bloating status is analyzed using logistic regression with Subject-reported (eDiary) - Abdominal Bloating as the dependent variable; treatment and surgical approach (open, laparoscopic) as covariates.|For Day 2||1.20|0.25|0.130
72509697|NCT04742907|144550117|SUPERIORITY||Odds Ratio (OR)|0.52||||0.099|TWO_SIDED|95.0|0.24|1.13||p value is assessing the null hypothesis that the odds ratio is equal to 1.|Regression, Logistic||Subject-reported (eDiary) - Abdominal Bloating status is analyzed using logistic regression with Subject-reported (eDiary) - Abdominal Bloating as the dependent variable; treatment and surgical approach (open, laparoscopic) as covariates.|For Day 2||1.13|0.24|0.099
72479783|NCT04677179|144485594|SUPERIORITY||LS Mean Difference|9.71|STANDARD_ERROR_OF_MEAN|10.935||0.378|TWO_SIDED|95.0|-12.17|31.6|||ANCOVA|||||31.60|-12.17|0.378
72479784|NCT04677179|144485594|SUPERIORITY||LS Mean Difference|-0.95|STANDARD_ERROR_OF_MEAN|10.406||0.928|TWO_SIDED|95.0|-21.78|19.88|||ANCOVA|||||19.88|-21.78|0.928
72479785|NCT02641496|144485619|OTHER|ANOVA||||||0.027||||||Significance threshold p\<0.05; one-tailed|ANOVA|||Treatment 1 to Treatment 4 (approximately first 30 days of treatment)||||0.027
72479786|NCT02641496|144485619|OTHER|ANOVA||||||0.919||||||Significance threshold p\<0.05; one-tailed|ANOVA|||Last 30 Days of 1 Year Study||||0.919
72479787|NCT02641496|144485620|OTHER|||||||0.696||||||Significance threshold p\<0.05; one-tailed|ANOVA|||||||0.696
72479788|NCT02641496|144485621|OTHER|||||||0.593||||||Significance threshold p\<0.05; two-tailed|ANOVA|||||||0.593
72479789|NCT02641496|144485622|OTHER|||||||0.925||||||Significance threshold p\<0.05; one-tailed|ANOVA|||||||0.925
72479790|NCT00600886|144485623|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.942||||0.007|TWO_SIDED|95.0|1.19|3.168|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel adjusting for randomization stratification factor||Overall - All patients||3.168|1.190|0.007
72479791|NCT00600886|144485623|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.337|||||TWO_SIDED|95.0|1.14|4.79||||||Post surgery - patients with prior surgery but no previous medical treatment for acromegaly||4.790|1.140|
72479792|NCT00600886|144485623|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.654|||||TWO_SIDED|95.0|0.846|3.234||||||De novo - patients with de novo disease who refused pituitary surgery or for whom pituitary surgery was contraindicated.||3.234|0.846|
72479793|NCT03075410|144485679|OTHER||Ratio|1.07|||||TWO_SIDED|90.0|0.87|1.34|||||Mixed Effect Model has been used to assess Food Effect for the log transformed parameter AUC(0-t). Treatment in the fed/fasted state is fitted as Fixed Effect. Participant is fitted as Random Effect. Variance Components covariance structure is used.|||1.34|0.87|
72479794|NCT03075410|144485680|OTHER||Ratio|0.94|||||TWO_SIDED|90.0|0.71|1.26|||||Mixed Effect Model has been used to assess Food Effect for the log transformed parameter AUC(0-inf). Treatment in the fed/fasted state is fitted as Fixed Effect. Participant is fitted as Random Effect. Variance Components covariance structure is use|||1.26|0.71|
72479795|NCT03075410|144485681|OTHER||Ratio|0.97|||||TWO_SIDED|90.0|0.76|1.23|||||Mixed Effect Model has been used to assess Food Effect for the log transformed parameter Cmax. Treatment in the fed/fasted state is fitted as Fixed Effect. Participant is fitted as Random Effect. Variance Components covariance structure is used.|||1.23|0.76|
72479796|NCT03075410|144485682|OTHER||Ratio|0.89|||||TWO_SIDED|90.0|0.64|1.23|||||Fixed Effect Model has been used to assess Food Effect for the log transformed parameter t1/2 Treatment in the fed/fasted state is fitted as Fixed Effect.|||1.23|0.64|
72479797|NCT03075410|144485683|OTHER||Median Difference (Final Values)|0.75|||||TWO_SIDED|90.0|-0.5|2.5|||||Hodges-Lehmann estimation is used to calculate the 90% confidence interval.|||2.50|-0.50|
72479798|NCT03075410|144485687|OTHER||Slope|1.1|||||TWO_SIDED|90.0|1.09|1.1|||||Mixed Effect Model has been used to assess Steady State. Day is fitted as a Fixed Effect. Participant is fitted as Random Effect Variance Components covariance structure is used.|Repeat GSK3036656 5mg Day 1-14||1.10|1.09|
72479799|NCT03075410|144485687|OTHER||Slope|1.08|||||TWO_SIDED|90.0|1.07|1.08|||||Mixed Effect Model has been used to assess Steady State. Day is fitted as a Fixed Effect. Participant is fitted as Random Effect Variance Components covariance structure is used.|Repeat GSK3036656 15mg Day 1-14||1.08|1.07|
72479800|NCT03075410|144485688|OTHER||Slope|0.96|||||TWO_SIDED|90.0|0.82|1.1|||||A slope of 1 indicates the pharmacokinetics are dose proportional. A slope greater than 1 indicates the increase in PK is greater than proportional to dose.||Power Model has been used to assess Dose Proportionality. Log-e(dose) is fitted as Fixed Effect and Participant is fitted as Random Effect. An Unstructured covariance structure is used.|1.10|0.82|
72479801|NCT03075410|144485689|OTHER||Slope|1.32|||||TWO_SIDED|90.0|1.24|1.39|||||Power Model has been used to assess Dose Proportionality. Log-e(dose) is fitted as Fixed Effect and Participant is fitted as Random Effect. An Unstructured covariance structure is used.|||1.39|1.24|
72479802|NCT03075410|144485690|OTHER||Slope|0.96|||||TWO_SIDED|90.0|0.81|1.11|||||Power Model has been used to assess Dose Proportionality. Log-e(dose) is fitted as Fixed Effect and Participant is fitted as Random Effect. An Unstructured covariance structure is used.|||1.11|0.81|
72479803|NCT03075410|144485691|OTHER||Slope|1.24|||||TWO_SIDED|90.0|1.15|1.33|||||Day 1.Power Model has been used to assess Dose Proportionality. Log-e(dose) is fitted as Fixed Effect.|||1.33|1.15|
72479804|NCT03075410|144485691|OTHER||Slope|1.06|||||TWO_SIDED|90.0|0.9|1.22|||||Day 14. Power Model has been used to assess Dose Proportionality. Log-e(dose) is fitted as Fixed Effect.|||1.22|0.90|
72479805|NCT03075410|144485692|OTHER||Slope|1.19|||||TWO_SIDED|90.0|0.92|1.46|||||Day 1. Power Model has been used to assess Dose Proportionality. Log-e(dose) is fitted as Fixed Effect.|||1.46|0.92|
72479806|NCT03075410|144485692|OTHER||Slope|1.06|||||TWO_SIDED|90.0|0.89|1.22|||||Day 14. Power Model has been used to assess Dose Proportionality. Log-e(dose) is fitted as Fixed Effect.|||1.22|0.89|
72479807|NCT03319849|144485713|SUPERIORITY||Median Difference (Final Values)|-0.049|STANDARD_ERROR_OF_MEAN|0.0206||0.0186|TWO_SIDED|95.0|-0.089|-0.0082|||Mixed Models Analysis|||||-0.0082|-0.0890|0.0186
72479808|NCT03938545|144485734|SUPERIORITY||Risk Difference (RD)|21.4|||=|0.1993|TWO_SIDED|95.0|-11.3|54.1||p-values were obtained from a Mantel-Haenszel test stratified by smoking status at baseline comparing RVT-1401 680 mg/Week group to placebo.|Cochran-Mantel-Haenszel||The risk difference was obtained from a weighted average of the difference within each stratum using Cochran Mantel-Haenszel weights.|||54.1|-11.3|=0.1993
72509698|NCT04742907|144550117|SUPERIORITY||Odds Ratio (OR)|0.78||||0.686|TWO_SIDED|95.0|0.23|2.63||p value is assessing the null hypothesis that the odds ratio is equal to 1.|Regression, Logistic||Subject-reported (eDiary) - Abdominal Bloating status is analyzed using logistic regression with Subject-reported (eDiary) - Abdominal Bloating as the dependent variable; treatment and surgical approach (open, laparoscopic) as covariates.|For Day 3||2.63|0.23|0.686
72400529|NCT00975481|144308991|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-26.4618|||<|0.0001|TWO_SIDED|95.0|-32.1455|-20.7782|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emax, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-20.7782|-32.1455|<0.0001
72400530|NCT00975481|144308991|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-23.4943|||<|0.0001|TWO_SIDED|95.0|-29.244|-17.7445|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emax, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-17.7445|-29.2440|<0.0001
72400531|NCT00975481|144308991|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.4538||||0.572|TWO_SIDED|95.0|-6.5274|3.6198|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emin, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||3.6198|-6.5274|0.5720
72479809|NCT03938545|144485734|SUPERIORITY||Risk Difference (RD)|24.2|||=|0.1016|TWO_SIDED|95.0|-4.8|53.2||p-values were obtained from a Mantel-Haenszel test stratified by smoking status at baseline comparing RVT-1401 340 mg/Week group to placebo.|Cochran-Mantel-Haenszel||The risk difference was obtained from a weighted average of the difference within each stratum using Cochran Mantel-Haenszel weights.|||53.2|-4.8|=0.1016
72479810|NCT03938545|144485734|SUPERIORITY||Risk Difference (RD)|-8.3|||=|0.2963|TWO_SIDED|95.0|-24.0|7.3||p-values were obtained from a Mantel-Haenszel test stratified by smoking status at baseline comparing RVT-1401 255 mg/Week group to placebo.|Cochran-Mantel-Haenszel||The risk difference was obtained from a weighted average of the difference within each stratum using Cochran Mantel-Haenszel weights.|||7.3|-24.0|=0.2963
72479811|NCT03938545|144485736|SUPERIORITY||Least Square Mean Difference|-60.085|||<|0.001|TWO_SIDED|95.0|-88.857|-31.313|||ANCOVA|The model included baseline value of the corresponding parameter, smoking stratum, and treatment group as covariates.||||-31.313|-88.857|<0.001
72479812|NCT03938545|144485736|SUPERIORITY||Least Square Mean Difference|-65.143|||<|0.001|TWO_SIDED|95.0|-91.927|-38.358|||ANCOVA|The model included baseline value of the corresponding parameter, smoking stratum, and treatment group as covariates.||||-38.358|-91.927|<0.001
72479813|NCT03938545|144485736|SUPERIORITY||Least Square Mean Difference|-37.323|||=|0.0284|TWO_SIDED|95.0|-70.455|-4.19|||ANCOVA|The model included baseline value of the corresponding parameter, smoking stratum, and treatment group as covariates.||||-4.190|-70.455|=0.0284
72479814|NCT03938545|144485737|SUPERIORITY||Least Square Mean Difference|-73.003|||<|0.001|TWO_SIDED|95.0|-82.309|-63.697|||ANCOVA|The model included baseline value of the corresponding parameter, smoking stratum, and treatment group as covariates.||Week 13||-63.697|-82.309|<0.001
72509699|NCT04742907|144550117|SUPERIORITY||Odds Ratio (OR)|0.75||||0.644|TWO_SIDED|95.0|0.22|2.56||p value is assessing the null hypothesis that the odds ratio is equal to 1.|Regression, Logistic||Subject-reported (eDiary) - Abdominal Bloating status is analyzed using logistic regression with Subject-reported (eDiary) - Abdominal Bloating as the dependent variable; treatment and surgical approach (open, laparoscopic) as covariates.|For Day 3||2.56|0.22|0.644
72479815|NCT03938545|144485737|SUPERIORITY||Least Square Mean Difference|-59.005|||<|0.001|TWO_SIDED|95.0|-67.821|-50.19|||ANCOVA|The model included baseline value of the corresponding parameter, smoking stratum, and treatment group as covariates.||Week 13||-50.190|-67.821|<0.001
72479816|NCT03938545|144485737|SUPERIORITY||Least Square Mean Difference|-51.836|||<|0.001|TWO_SIDED|95.0|-62.66|-41.012|||ANCOVA|The model included baseline value of the corresponding parameter, smoking stratum, and treatment group as covariates.||Week 13||-41.012|-62.660|<0.001
72479817|NCT03938545|144485738|SUPERIORITY||Least Square Mean Difference|-81.49|||<|0.001|TWO_SIDED|95.0|-93.203|-69.777|||ANCOVA|The model included baseline value of the corresponding parameter, smoking stratum, and treatment group as covariates.||IgG1||-69.777|-93.203|<0.001
72479818|NCT03938545|144485738|SUPERIORITY||Least Square Mean Difference|-67.591|||<|0.001|TWO_SIDED|95.0|-78.562|-56.62|||ANCOVA|The model included baseline value of the corresponding parameter, smoking stratum, and treatment group as covariates.||IgG1||-56.620|-78.562|<0.001
72479819|NCT03938545|144485738|SUPERIORITY||Least Square Mean Difference|-67.233|||<|0.001|TWO_SIDED|95.0|-81.073|-53.394|||ANCOVA|The model included baseline value of the corresponding parameter, smoking stratum, and treatment group as covariates.||IgG1||-53.394|-81.073|<0.001
72479820|NCT03938545|144485738|SUPERIORITY||Least Square Mean Difference|-74.865|||<|0.001|TWO_SIDED|95.0|-86.898|-62.832|||ANCOVA|The model included baseline value of the corresponding parameter, smoking stratum, and treatment group as covariates.||IgG2||-62.832|-86.898|<0.001
72479821|NCT03938545|144485738|SUPERIORITY||Least Square Mean Difference|-53.198|||<|0.001|TWO_SIDED|95.0|-64.799|-41.596|||ANCOVA|The model included baseline value of the corresponding parameter, smoking stratum, and treatment group as covariates.||IgG2||-41.596|-64.799|<0.001
72479822|NCT03938545|144485738|SUPERIORITY||Least Square Mean Difference|-53.398|||<|0.001|TWO_SIDED|95.0|-67.552|-39.245|||ANCOVA|The model included baseline value of the corresponding parameter, smoking stratum, and treatment group as covariates.||IgG2||-39.245|-67.552|<0.001
72479823|NCT03938545|144485738|SUPERIORITY||Least Square Mean Difference|-88.764|||<|0.001|TWO_SIDED|95.0|-103.039|-74.489|||ANCOVA|The model included baseline value of the corresponding parameter, smoking stratum, and treatment group as covariates.||IgG3||-74.489|-103.039|<0.001
72509700|NCT04742907|144550117|SUPERIORITY||Odds Ratio (OR)|0.54||||0.498|TWO_SIDED|95.0|0.09|3.18||p value is assessing the null hypothesis that the odds ratio is equal to 1.|Regression, Logistic||Subject-reported (eDiary) - Abdominal Bloating status is analyzed using logistic regression with Subject-reported (eDiary) - Abdominal Bloating as the dependent variable; treatment and surgical approach (open, laparoscopic) as covariates.|For Day 4||3.18|0.09|0.498
72400532|NCT00975481|144308991|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.9938||||0.0006|TWO_SIDED|95.0|-14.0695|-3.918|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emin, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-3.9180|-14.0695|0.0006
72479824|NCT03938545|144485738|SUPERIORITY||Least Square Mean Difference|-65.714|||<|0.001|TWO_SIDED|95.0|-78.742|-52.686|||ANCOVA|The model included baseline value of the corresponding parameter, smoking stratum, and treatment group as covariates.||IgG3||-52.686|-78.742|<0.001
72479825|NCT03938545|144485738|SUPERIORITY||Least Square Mean Difference|-66.685|||<|0.001|TWO_SIDED|95.0|-83.157|-50.214|||ANCOVA|The model included baseline value of the corresponding parameter, smoking stratum, and treatment group as covariates.||IgG3||-50.214|-83.157|<0.001
72479826|NCT03938545|144485738|SUPERIORITY||Least Square Mean Difference|-68.722|||<|0.001|TWO_SIDED|95.0|-80.877|-56.568|||ANCOVA|The model included baseline value of the corresponding parameter, smoking stratum, and treatment group as covariates.||IgG4||-56.568|-80.877|<0.001
72479827|NCT03938545|144485738|SUPERIORITY||Least Square Mean Difference|-55.554|||<|0.001|TWO_SIDED|95.0|-67.182|-43.926|||ANCOVA|The model included baseline value of the corresponding parameter, smoking stratum, and treatment group as covariates.||IgG4||-43.926|-67.182|<0.001
72479828|NCT03938545|144485738|SUPERIORITY||Least Square Mean Difference|-53.079|||<|0.001|TWO_SIDED|95.0|-67.948|-38.21|||ANCOVA|The model included baseline value of the corresponding parameter, smoking stratum, and treatment group as covariates.||IgG4||-38.210|-67.948|<0.001
72479829|NCT01060540|144485739|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.2||||0.44|TWO_SIDED|95.0|-0.3|0.7|||Mixed Models Analysis|Adjusted for family history (low/unknown vs. high/moderate) and BMI\>=35 (yes vs no) stratification variables||||0.7|-0.3|0.44
72479830|NCT01060540|144485740|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.1||||0.19|TWO_SIDED|95.0|-0.1|0.3||adjusted for baseline BMI class and family history level stratification variables|Mixed Models Analysis|||||0.3|-0.1|0.19
72479831|NCT01060540|144485741|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1||||0.38|TWO_SIDED|95.0|-0.4|0.1||adjusted for stratification variables baseline BMI and family history|Mixed Models Analysis|||||0.1|-0.4|0.38
72479832|NCT01060540|144485742|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1||||0.05|TWO_SIDED|95.0|-0.2|0.0||adjusted for baseline family history and BMI|Mixed Models Analysis|||||0.0|-0.2|0.05
72479833|NCT01060540|144485743|SUPERIORITY_OR_OTHER||incident rate ratio|0.9||||0.68|TWO_SIDED|95.0|0.7|1.2||adjusted for baseline family history and BMI|generalized linear model for count data|||||1.2|0.7|0.68
72479834|NCT03310268|144485744|OTHER||Difference of Least Square mean|0.19|STANDARD_ERROR_OF_MEAN|0.094||0.0476|TWO_SIDED|95.0|0.002|0.374|||ANCOVA|From ANCOVA model with treatment as factor and baseline Schiff score as covariate.|Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|||0.374|0.002|0.0476
72479835|NCT03310268|144485744|OTHER||Difference of Least Square mean|-0.02|STANDARD_ERROR_OF_MEAN|0.093||0.8411|TWO_SIDED|95.0|-0.202|0.164|||ANCOVA|From ANCOVA model with treatment as factor and baseline Schiff score as covariate.|Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|||0.164|-0.202|0.8411
72479836|NCT03310268|144485744|OTHER||Difference of Least Square mean|0.21|STANDARD_ERROR_OF_MEAN|0.094||0.0298|TWO_SIDED|95.0|0.02|0.393|||ANCOVA|From ANCOVA model with treatment as factor and baseline Schiff score as covariate.|Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|||0.393|0.020|0.0298
72479837|NCT03310268|144485745|OTHER||Difference of Least Square mean|-7.2|STANDARD_ERROR_OF_MEAN|4.649||0.1232|TWO_SIDED|95.0|-16.376|1.975|||ANCOVA|From ANCOVA model with treatment and baseline Schiff stratification as factors and baseline tactile threshold as a covariate.|Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|||1.975|-16.376|0.1232
72479838|NCT03310268|144485745|OTHER||Difference of Least Square mean|-4.04|STANDARD_ERROR_OF_MEAN|4.588||0.3793|TWO_SIDED|95.0|-13.099|5.011|||ANCOVA|From ANCOVA model with treatment and baseline Schiff stratification as factors and baseline tactile threshold as a covariate.|Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|||5.011|-13.099|0.3793
72479839|NCT03310268|144485745|OTHER||Difference of Least Square mean|-3.16|STANDARD_ERROR_OF_MEAN|4.648||0.4979|TWO_SIDED|95.0|-12.33|6.017|||ANCOVA|From ANCOVA model with treatment and baseline Schiff stratification as factors and baseline tactile threshold as a covariate.|Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|||6.017|-12.330|0.4979
72479840|NCT02527343|144485748|SUPERIORITY||Difference in Least Square Mean|-66.83||||0.0009|TWO_SIDED|95.0|-104.17|-29.48|||ANCOVA|||||-29.48|-104.17|0.0009
72479841|NCT02527343|144485749|SUPERIORITY||Difference in Least Square Mean|-25.69||||0.0736|TWO_SIDED|95.0|-54.03|2.65|||ANCOVA|||Month 6||2.65|-54.03|0.0736
72479842|NCT02527343|144485749|SUPERIORITY||Difference in Least Square Mean|-53.33||||0.0039|TWO_SIDED|95.0|-87.71|-18.95|||ANCOVA|||Month 12||-18.95|-87.71|0.0039
72479843|NCT02527343|144485751|SUPERIORITY||Difference in Least Square Mean|0.3||||0.4108|TWO_SIDED|95.0|-0.43|1.03|||ANCOVA|||Month 3||1.03|-0.43|0.4108
72479844|NCT02527343|144485751|SUPERIORITY||Difference in Least Square Mean|0.19||||0.7308|TWO_SIDED|95.0|-0.95|1.34|||ANCOVA|||Month 6||1.34|-0.95|0.7308
72479845|NCT02527343|144485751|SUPERIORITY||Difference in Least Square Mean|-0.2||||0.7511|TWO_SIDED|95.0|-1.45|1.06|||ANCOVA|||Month 9||1.06|-1.45|0.7511
72479846|NCT02527343|144485751|SUPERIORITY||Difference in Least Square Mean|-0.19||||0.7659|TWO_SIDED|95.0|-1.52|1.13|||ANCOVA|||Month 12||1.13|-1.52|0.7659
72479847|NCT02700945|144485768|SUPERIORITY|The 12-month Kaplan-Meier estimate will be reported for each arm. The hazard ratio estimate for the treatment effect with its 95% confidence interval will be reported.|Hazard Ratio (HR)|7.4|||<|0.001|TWO_SIDED|95.0|2.6|21.3||A priori threshold is .05|Log Rank||A hazard ratio of \> 1 indicates that continuous monitoring arm is superior to control arm in detecting AF.|H0: h(t) = hT(t) for t ≤ 12 months HA: hC(t) ≠ hT(t) for t ≤ 12 months where hT(t) and hC(t) are the hazard functions of first detected and adjudicated AF at time t for subjects with and without the Reveal LINQ diagnostics for AF, respectively. Hazard functions and survival functions are transformations of each other.||21.3|2.6|<0.001
72623655|NCT00600340|144778114|SUPERIORITY|HR is the hazard rate of Bevacizumab Plus Capecitabine divided by hazard rate of Bevacizumab plus Paclitaxel.|Hazard Ratio (HR)|0.56||||0.0001|TWO_SIDED|95.0|0.41|0.75||Two-sided log-rank test adjusted by stratification factors at randomization|Log Rank||HR is the hazard rate of Bevacizumab Plus Capecitabine divided by hazard rate of Bevacizumab plus Paclitaxel.|"HR of Bevacizumab Plus Capecitabine vs. Bevacizumab plus Paclitaxel for TR (stratified)~Based on Cox proportional hazards model adjusted by stratification factors at randomization:~1. estrogen and/or progesterone status (positive vs. other)~2. country~3. menopausal status (premenopausal or male \<=50 years of age vs. postmenopausal or male \>50 years of age)"||0.75|0.41|0.0001
72623656|NCT00600340|144778115|SUPERIORITY|HR is the hazard rate of Bevacizumab Plus Capecitabine divided by hazard rate of Bevacizumab plus Paclitaxel.|Hazard Ratio (HR)|1.41||||0.0582|TWO_SIDED|95.0|0.99|2.02||Two-sided log-rank test adjusted by stratification factors at randomization|Log Rank||HR is the hazard rate of Bevacizumab Plus Capecitabine divided by hazard rate of Bevacizumab plus Paclitaxel.|"HR of Bevacizumab Plus Capecitabine vs. Bevacizumab plus Paclitaxel for DR (stratified)~Based on Cox proportional hazards model adjusted by stratification factors at randomization:~1. estrogen and/or progesterone status (positive vs. other)~2. country~3. menopausal status (premenopausal or male \<=50 years of age vs. postmenopausal or male \>50 years of age)"||2.02|0.99|0.0582
72623657|NCT00600340|144778116|SUPERIORITY|HR is the hazard rate of Arm B divided by hazard rate of Arm A.|Hazard Ratio (HR)|1.45||||0.0429|TWO_SIDED|95.0|1.01|2.1||Two-sided log-rank test adjusted by stratification factors at randomization|Log Rank||HR is the hazard rate of Arm B divided by hazard rate of Arm A.|"HR of Arm B vs. Arm A for DR (stratified)~Based on Cox proportional hazards model adjusted by stratification factors at randomization:~1. estrogen and/or progesterone status (positive vs. other)~2. country~3. menopausal status (premenopausal or male \<=50 years of age vs. postmenopausal or male \>50 years of age)"||2.10|1.01|0.0429
72509701|NCT04742907|144550117|SUPERIORITY||Odds Ratio (OR)|0.71||||0.7|TWO_SIDED|95.0|0.12|4.05||p value is assessing the null hypothesis that the odds ratio is equal to 1.|Regression, Logistic||Subject-reported (eDiary) - Abdominal Bloating status is analyzed using logistic regression with Subject-reported (eDiary) - Abdominal Bloating as the dependent variable; treatment and surgical approach (open, laparoscopic) as covariates.|For Day 4||4.05|0.12|0.700
72623658|NCT00376558|144778121|SUPERIORITY_OR_OTHER|||||||0.003|||||||ANOVA|||||||0.003
72479848|NCT04745026|144485770|SUPERIORITY||Least square mean difference|3.37|STANDARD_ERROR_OF_MEAN|1.931|=|0.085|TWO_SIDED|95.0|-0.48|7.21||Randomization factors, baseline score, visit, treatment arm, visit by treatment arm (fixed), and visit repeated within each patient (repeated).|Mixed models for repeated measures|||Irritability (Week 12)||7.21|-0.48|=0.085
72479849|NCT04745026|144485770|SUPERIORITY||Least square mean difference|1.14|STANDARD_ERROR_OF_MEAN|1.16|=|0.3107|TWO_SIDED|95.0|-1.08|3.36|||Mixed models for repeated measures|Randomization factors, baseline score, visit, treatment arm, visit by treatment arm (fixed), and visit repeated within each patient (repeated).||Social Withdrawal Week 12)||3.36|-1.08|=0.3107
72479850|NCT04745026|144485770|SUPERIORITY||Least square mean difference|0.04|STANDARD_ERROR_OF_MEAN|0.695|=|0.9513|TWO_SIDED|95.0|-1.34|1.42|||Mixed models for repeated measures|Randomization factors, baseline score, visit, treatment arm, visit by treatment arm (fixed), and visit repeated within each patient (repeated).||Stereotypic Behavior (Week 12)||1.42|-1.34|=0.9513
72479851|NCT04745026|144485770|SUPERIORITY||Least square mean difference|2.01|STANDARD_ERROR_OF_MEAN|1.943|=|0.305|TWO_SIDED|95.0|-1.86|5.88|||Mixed models repeated measures|Randomization factors, baseline score, visit, treatment arm, visit by treatment arm (fixed), and visit repeated within each patient (repeated).||Hyperactivity/Noncompliance (Week 12)||5.88|-1.86|=0.305
72479852|NCT04745026|144485770|SUPERIORITY||Least square mean difference|-0.37|STANDARD_ERROR_OF_MEAN|0.517|=|0.4754|TWO_SIDED|95.0|-1.4|0.66|||Mixed models repeated measures|Randomization factors, baseline score, visit, treatment arm, visit by treatment arm (fixed), and visit repeated within each patient (repeated).||Inappropriate Speech (Week 12)||0.66|-1.4|=0.4754
72479853|NCT04745026|144485771|SUPERIORITY||Least square mean difference|0.45|STANDARD_ERROR_OF_MEAN|2.36|=|0.8506|TWO_SIDED|95.0|-4.26|5.15|||Mixed models for repeated measures|Randomization factors, baseline score, visit, treatment arm, visit by treatment arm (fixed), and visit repeated within each patient (repeated).||Week 12||5.15|-4.26|=0.8506
72479854|NCT04745026|144485772|SUPERIORITY||Odds Ratio (OR)|1.22|||=|0.7087|TWO_SIDED|95.0|0.43|3.51|||Regression, Logistic|Includes treatment arm, randomization variables and baseline score (CGI-S) covariates. Responders achieved a score of 1 or 2 at post-baseline visits.||Responders with 'Very Much Improved' or 'Much Improved' response at week 12||3.51|0.43|=0.7087
72479855|NCT04745026|144485773|SUPERIORITY||||||=|0.6108|||||||Cochran-Mantel-Haenszel|||Week 12||||=0.6108
72479856|NCT04426851|144485784|OTHER||Ratio of the geometric means (%)|45.9|||||TWO_SIDED|90.0|41.4|50.9|||||"Ratio was calculated as: BI 1358894 100 mg tablet fasted/BI 1358894 (C-14) 100 ug i.v.~Intra-individual geometric coefficient of variation (gCV)=14.3."|The Analysis of variance (ANOVA) model included effects accounting for the following sources of variation: 'subjects' and 'formulation'. The effect 'subjects' was considered as random, whereas 'formulation' was considered as fixed.||50.9|41.4|
72479857|NCT04426851|144485785|OTHER||Ratio of the geometric means (%)|141.4|||||TWO_SIDED|90.0|129.3|154.6|||||Ratio was calculated as: BI 1358894 100 mg oral suspension fed/BI 1358894 100 mg oral suspension fasted. Intra -individual geometric coefficient of variation (gCV)=10.9.|The ANOVA model included effects accounting for the following sources of variation: 'sequence or block', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||154.6|129.3|
72479858|NCT04426851|144485787|OTHER||Ratio of the geometric means (%)|65.3|||||TWO_SIDED|90.0|54.6|78.0|||||Ratio was calculated as: BI 1358894 100 mg oral suspension fed/BI 1358894 100 mg oral suspension fasted. Intra - individual geometric coefficient of variation (gCV)=22.5.|The ANOVA model included effects accounting for the following sources of variation: 'sequence or block', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||78.0|54.6|
72576860|NCT00261443|144680664|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.07||||0.653|TWO_SIDED|95.0|-0.39|0.25||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 12 Comparison||0.25|-0.39|0.653
72479859|NCT04426851|144485788|OTHER||Ratio of the geometric means (%)|148.4|||||TWO_SIDED|90.0|138.1|159.5|||||Ratio was calculated as: BI 1358894 100 mg oral suspension fed/BI 1358894 100 mg oral suspension fasted. Intra - individual geometric coefficient of variation (gCV) =8.7.|The ANOVA model included effects accounting for the following sources of variation: 'sequence or block', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||159.5|138.1|
72479860|NCT00825916|144485812|SUPERIORITY_OR_OTHER|||||||0.078||95.0|||||Wilcoxon (rank sum)|For this early phase study, no adjustment was used.||||||0.078
72479861|NCT00825916|144485812|SUPERIORITY_OR_OTHER|||||||0.086||95.0|||||Wilcoxon (rank sum)|For this early phase study, no adjustment was used.||||||0.086
72479862|NCT00825916|144485812|SUPERIORITY_OR_OTHER|||||||0.92||95.0|||||Wilcoxon (rank sum)|For this early phase study, no adjustment was used.||||||0.92
72479863|NCT00825916|144485812|SUPERIORITY_OR_OTHER|||||||0.49||95.0|||||Wilcoxon (rank sum)|For this early phase study, no adjustment was used.||||||0.49
72509702|NCT04742907|144550118|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.919|TWO_SIDED|95.0|-0.9|0.8|||Mixed Models Analysis|||For Day 1, LS mean difference between placebo and TU-100 15 g/day. Mixed Model Repeated Measures approach was used to assess the bothersomeness of Abdominal Bloating as the dependent variable and treatment group, surgical approach and treatment group by visit as covariates. An unstructured covariance structure is used to model the within-subject errors, shared across treatments.||0.8|-0.9|0.919
72509703|NCT04742907|144550118|SUPERIORITY||Mean Difference (Final Values)|-1.0||||0.016|TWO_SIDED|95.0|-1.8|-0.2|||Mixed Models Analysis|||For Day 1, LS mean difference between placebo and TU-100 7.5 g/day. Mixed Model Repeated Measures approach was used to assess the bothersomeness of Abdominal Bloating as the dependent variable and treatment group, surgical approach and treatment group by visit as covariates. An unstructured covariance structure is used to model the within-subject errors, shared across treatments.||-0.2|-1.8|0.016
72509704|NCT04742907|144550118|SUPERIORITY||Mean Difference (Final Values)|1.0||||0.064|TWO_SIDED|95.0|-0.1|2.0|||Mixed Models Analysis|||For Day 2, LS mean difference between placebo and TU-100 15 g/day. Mixed Model Repeated Measures approach was used to assess the bothersomeness of Abdominal Bloating as the dependent variable and treatment group, surgical approach and treatment group by visit as covariates. An unstructured covariance structure is used to model the within-subject errors, shared across treatments.||2.0|-0.1|0.064
72479864|NCT00825916|144485813|SUPERIORITY_OR_OTHER|||||||0.74||95.0|||||Wilcoxon (rank sum)|For this early phase study, no adjustment was used.||||||0.74
72479865|NCT00825916|144485813|SUPERIORITY_OR_OTHER|||||||0.59||95.0|||||Wilcoxon (rank sum)|For this early phase study, no adjustment was used.||||||0.59
72479866|NCT00825916|144485813|SUPERIORITY_OR_OTHER|||||||0.69||95.0|||||Wilcoxon (rank sum)|For this early phase study, no adjustment was used.||||||0.69
72479867|NCT00825916|144485813|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Wilcoxon (rank sum)|For this early phase study, no adjustment was used.||||||1.00
72479868|NCT00825916|144485814|SUPERIORITY_OR_OTHER|||||||0.34||95.0|||||Wilcoxon (rank sum)|For this early phase study, no adjustment was used.||||||0.34
72479869|NCT00825916|144485814|SUPERIORITY_OR_OTHER|||||||0.98||95.0|||||Wilcoxon (rank sum)|For this early phase study, no adjustment was used.||||||0.98
72479870|NCT00825916|144485814|SUPERIORITY_OR_OTHER|||||||0.15||95.0|||||Wilcoxon (rank sum)|For this early phase study, no adjustment was used.||||||0.15
72479871|NCT00825916|144485814|SUPERIORITY_OR_OTHER|||||||0.83||95.0|||||Wilcoxon (rank sum)|For this early phase study, no adjustment was used.||||||0.83
72479872|NCT00825916|144485814|SUPERIORITY_OR_OTHER|||||||0.95||95.0|||||Wilcoxon (rank sum)|For this early phase study, no adjustment was used.||||||0.95
72479873|NCT00825916|144485814|SUPERIORITY_OR_OTHER|||||||0.59||95.0|||||Wilcoxon (rank sum)|For this early phase study, no adjustment was used.||||||0.59
72479874|NCT00825916|144485814|SUPERIORITY_OR_OTHER|||||||0.76||95.0|||||Wilcoxon (rank sum)|For this early phase study, no adjustment was used.||||||0.76
72509705|NCT04742907|144550118|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.683|TWO_SIDED|95.0|-1.3|0.8|||Mixed Models Analysis|||For Day 2, LS mean difference between placebo and TU-100 7.5 g/day. Mixed Model Repeated Measures approach was used to assess the bothersomeness of Abdominal Bloating as the dependent variable and treatment group, surgical approach and treatment group by visit as covariates. An unstructured covariance structure is used to model the within-subject errors, shared across treatments.||0.8|-1.3|0.683
72509706|NCT04742907|144550118|SUPERIORITY||Mean Difference (Final Values)|0.6||||0.462|TWO_SIDED|95.0|-1.0|2.1|||Mixed Models Analysis|||For Day 3, LS mean difference between placebo and TU-100 15 g/day. Mixed Model Repeated Measures approach was used to assess the bothersomeness of Abdominal Bloating as the dependent variable and treatment group, surgical approach and treatment group by visit as covariates. An unstructured covariance structure is used to model the within-subject errors, shared across treatments.||2.1|-1.0|0.462
72509707|NCT04742907|144550118|SUPERIORITY||Mean Difference (Final Values)|-0.8||||0.343|TWO_SIDED|95.0|-2.3|0.8|||Mixed Models Analysis|||For Day 3, LS mean difference between placebo and TU-100 7.5 g/day. Mixed Model Repeated Measures approach was used to assess the bothersomeness of Abdominal Bloating as the dependent variable and treatment group, surgical approach and treatment group by visit as covariates. An unstructured covariance structure is used to model the within-subject errors, shared across treatments.||0.8|-2.3|0.343
72509708|NCT00365716|144550120|SUPERIORITY_OR_OTHER||Vaccine Efficacy|89.5||||||95.0|70.7|97.3|||||"Vaccine Efficacy (% relative risk reduction)~Confidence Interval based on binomial tail probabilities and not from a dispersion parameter."|||97.3|70.7|
72509709|NCT06150573|144550123|SUPERIORITY||Adjusted Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.498||0.9141|TWO_SIDED|95.0|-1.04|0.93|||ANOVA|||||0.93|-1.04|0.9141
72509710|NCT06150573|144550124|SUPERIORITY||Adjusted Mean Difference|0.37|STANDARD_ERROR_OF_MEAN|0.494||0.4583|TWO_SIDED|95.0|-0.61|1.34|||ANOVA|||||1.34|-0.61|0.4583
72479875|NCT00825916|144485814|SUPERIORITY_OR_OTHER|||||||0.63||95.0|||||Wilcoxon (rank sum)|For this early phase study, no adjustment was used.||||||0.63
72623659|NCT00376558|144778122|SUPERIORITY_OR_OTHER||delta bpnd|-12.0|STANDARD_DEVIATION|7.0||0.001|TWO_SIDED|95.0|||||t-test, 2 sided|||The limbic striatum was our primary region of interest using an unpaired t test to compare BPND and deltaBPND between the treatment responders and non-responders.||||0.001
72479876|NCT00825916|144485814|SUPERIORITY_OR_OTHER|||||||0.92||95.0|||||Wilcoxon (rank sum)|For this early phase study, no adjustment was used.||||||0.92
72623660|NCT04047355|144778158|SUPERIORITY||Median Difference (Final Values)|3.0||||0.12|TWO_SIDED|||||The a-priori threshold for statistical significance was set at α = 0.05.|Wilcoxon (Mann-Whitney)||The placebo phase serves as the control condition and the propranolol phase serves as the treatment condition.|A post-hoc power analysis was conducted using G\*Power, v. 3.1, to determine the achieved power for the Wilcoxon signed-rank test for matched pairs.||||0.12
72479877|NCT00825916|144485814|SUPERIORITY_OR_OTHER|||||||0.69||95.0|||||Wilcoxon (rank sum)|For this early phase study, no adjustment was used.||||||0.69
72479878|NCT00825916|144485815|SUPERIORITY_OR_OTHER|||||||0.95|TWO_SIDED|95.0|||||Wilcoxon (signed rank)|For this early phase study, no adjustment was used.||||||0.95
72479879|NCT00825916|144485815|SUPERIORITY_OR_OTHER|||||||0.76|TWO_SIDED|95.0||||For this early phase study, no adjustment was used.|Wilcoxon (signed rank)|||||||0.76
72479880|NCT00825916|144485815|SUPERIORITY_OR_OTHER|||||||0.6|TWO_SIDED|95.0||||For this early phase study, no adjustment was used.|Wilcoxon (signed rank)|||||||0.60
72479881|NCT00825916|144485815|SUPERIORITY_OR_OTHER|||||||0.44|TWO_SIDED|95.0||||For this early phase study, no adjustment was used.|Wilcoxon (signed rank)|||||||0.44
72479882|NCT00825916|144485815|SUPERIORITY_OR_OTHER|||||||0.85|TWO_SIDED|95.0||||For this early phase study, no adjustment was used.|Wilcoxon (signed rank)|||||||0.85
72479883|NCT00825916|144485815|SUPERIORITY_OR_OTHER|||||||0.83|TWO_SIDED|95.0||||For this early phase study, no adjustment was used.|Wilcoxon (signed rank)|||||||0.83
72479884|NCT01778023|144485816|SUPERIORITY_OR_OTHER||Treatment Difference|5.15|||<|0.0001|TWO_SIDED|95.0|4.09|6.21|||ANOVA|The HV after 6 months of treatment was analysed using an ANCOVA method with group and sex as fixed effects, and age as a covariate.||Let D be a mean difference of the primary endpoint between group A and group B. Null hypothesis H0: D = 0 vs. alternative H1: D ≠ 0 will be statistically tested by an ANOVA model.||6.21|4.09|<0.0001
72479885|NCT03086213|144485871|NON_INFERIORITY|the definition of non-inferiority analysis is that the new method is no less effective than standard interventions.|Mean Difference (Final Values)|10.0|STANDARD_DEVIATION|0.025||0.025|TWO_SIDED|95.0|5.0|95.0||whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance|t-test, 2 sided|degrees of freedom|Paravertebral nerve block arm represents the numerator and intercostal block represents the denominator for relative risk|null hypothesis||95|5|0.025
72623661|NCT04047355|144778158|SUPERIORITY||Effect size (r)|-0.64|||||TWO_SIDED|||||||||||||
72623662|NCT04047355|144778158|SUPERIORITY||Post-hoc power analysis|0.39|||||TWO_SIDED||||||||The alpha error probability was set at α = 0.05 (two-tailed).|||||
72479886|NCT03086213|144485872|SUPERIORITY|During the calculation of sample size,a sample size of 24 patients per group was calculated as being required to ensure 90% power of detecting the difference-if any-as statistically significant at the 5% level|||||<|0.05||||||the p-value is not adjusted for multiple comparisons and the a priori threshold for statistical significance.|t-test, 2 sided|degrees of freedom is defined as sample size subtraction one.||null hypothesis||||<0.05
72479887|NCT03086213|144485875|SUPERIORITY|During the calculation of sample size,a sample size of 24 patients per group was calculated as being required to ensure 90% power of detecting the difference-if any-as statistically significant at the 5% level||||||0.05|||||||t-test, 2 sided|Degree of freedom is defined as sample size subtraction one.||null hypothesis||||0.05
72479888|NCT01616056|144485895|SUPERIORITY|||||||0.01|||||||Wilcoxon (Mann-Whitney)|||||||0.01
72479889|NCT01616056|144485897|SUPERIORITY|||||||0.002|||||||Wilcoxon (Mann-Whitney)|||||||0.002
72479890|NCT01616056|144485899|SUPERIORITY|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||||||0.001
72479891|NCT01616056|144485902|SUPERIORITY|||||||0.005|||||||Wilcoxon (Mann-Whitney)|||||||0.005
72479892|NCT00138671|144485918|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||||90.0|-0.17|0.36||||||Week 6||0.36|-0.17|
72479893|NCT00138671|144485918|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01||||||90.0|-0.27|0.26||||||Week 12||0.26|-0.27|
72479894|NCT00138671|144485918|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02||||||90.0|-0.29|0.26||||||Week 26||0.26|-0.29|
72479895|NCT00138671|144485918|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.08||||||90.0|-0.36|0.2||||||Week 39||0.20|-0.36|
72479896|NCT00138671|144485918|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.06||||||90.0|-0.23|0.35||||||Week 52||0.35|-0.23|
72479897|NCT00138671|144485918|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01||||||90.0|-0.29|0.31||||||Week 52 LOCF||0.31|-0.29|
72479898|NCT00138671|144485919|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.475||||||90.0|-23.47|14.518||||||Week 6||14.518|-23.47|
72479899|NCT00138671|144485919|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.91||||||90.0|-30.04|8.232||||||Week 12||8.232|-30.04|
72479900|NCT00138671|144485919|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-22.84||||||90.0|-42.51|-3.166||||||Week 26||-3.166|-42.51|
72479901|NCT00138671|144485919|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.222||||||90.0|-28.52|12.075||||||Week 39||12.075|-28.52|
72479902|NCT00138671|144485919|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.329||||||90.0|-29.27|12.616||||||Week 52||12.616|-29.27|
72479903|NCT00138671|144485919|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.406||||||90.0|-13.7|16.514||||||Week 52 LOCF||16.514|-13.70|
72479904|NCT00138671|144485920|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.884||||||90.0|-0.317|2.084||||||Week 1||2.084|-0.317|
72479905|NCT00138671|144485920|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.47||||||90.0|-0.728|1.668||||||Week 2||1.668|-0.728|
72479906|NCT00138671|144485920|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.382||||||90.0|-0.815|1.579||||||Week 3||1.579|-0.815|
72479907|NCT00138671|144485920|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.405||||||90.0|-0.793|1.602||||||Week 4||1.602|-0.793|
72479908|NCT00138671|144485920|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.562||||||90.0|-0.642|1.766||||||Week 6||1.766|-0.642|
72623663|NCT04047355|144778159|SUPERIORITY||Median Difference (Final Values)|2.0||||0.07|TWO_SIDED|||||The a-priori threshold for statistical significance was set at α = 0.05.|Wilcoxon (Mann-Whitney)||The placebo phase serves as the control condition and the propranolol phase serves as the treatment condition.|A post-hoc power analysis was conducted using G\*Power, v. 3.1, to determine the achieved power for the Wilcoxon signed-rank test for matched pairs.||||0.07
72623664|NCT04047355|144778159|SUPERIORITY||Effect size (r)|-0.74|||||TWO_SIDED|||||||||||||
72623665|NCT04047355|144778159|SUPERIORITY||Post-hoc power analysis|0.59|||||TWO_SIDED||||||||The alpha error probability was set at α = 0.05 (two-tailed).|||||
72623666|NCT00023595|144778160|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.86||||0.12|TWO_SIDED|95.0|0.72|1.04|||Log Rank||Hazard Ratio is for (H01: Medication +CABG) versus (H01: Medication)|||1.04|0.72|0.12
72623667|NCT00023595|144778161|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.84||||0.02|TWO_SIDED|95.0|0.73|0.97|||Log Rank||Hazard Ratio is for (H01: Medication +CABG) versus (H01: Medication)|||0.97|0.73|0.02
72623668|NCT00023595|144778162|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.99||||0.9|TWO_SIDED|95.0|0.84|1.17|||Log Rank||Hazard Ratio is for (H02: Medication + CABG + SVR) versus (H02: Medication + CABG)|||1.17|0.84|0.90
72400533|NCT00975481|144308991|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.8686||||0.4704|TWO_SIDED|95.0|-3.2342|6.9713|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emin, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||6.9713|-3.2342|0.4704
72479909|NCT00138671|144485920|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.416||||||90.0|-0.809|1.641||||||Week 9||1.641|-0.809|
72509711|NCT06150573|144550125|SUPERIORITY||Adjusted Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.061||0.0042|TWO_SIDED|95.0|-0.3|-0.06|||ANOVA|||Week 12||-0.06|-0.30|0.0042
72509712|NCT06150573|144550125|SUPERIORITY||Adjusted Mean Difference|-0.31|STANDARD_ERROR_OF_MEAN|0.074|<|0.0001|TWO_SIDED|95.0|-0.46|-0.17|||ANOVA|||Week 24||-0.17|-0.46|<0.0001
72509713|NCT06150573|144550126|SUPERIORITY||Adjusted Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.016||0.2478|TWO_SIDED|95.0|-0.05|0.01|||ANOVA|||Mean Gingival MLSI, Week 12||0.01|-0.05|0.2478
72623669|NCT00023595|144778163|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio, log|0.79||||0.006|TWO_SIDED|95.0|0.66|0.93|||Log Rank||Hazard Ratio is for (H01: Medication +CABG) versus (H01: Medication)|||0.93|0.66|0.006
72623670|NCT00023595|144778164|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.81||||0.05|TWO_SIDED|95.0|0.66|1.0|||Log Rank||Hazard Ratio is for (H01: Medication +CABG) versus (H01: Medication)|||1.00|0.66|0.05
72479910|NCT00138671|144485920|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.019||||||90.0|-1.416|1.454||||||Week 11||1.454|-1.416|
72479911|NCT00138671|144485920|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.091||||||90.0|-1.127|1.308||||||Week 12||1.308|-1.127|
72479912|NCT00138671|144485920|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.309||||||90.0|-1.551|0.934||||||Week 18||0.934|-1.551|
72479913|NCT00138671|144485920|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.869||||||90.0|-2.123|0.384||||||Week 26||0.384|-2.123|
72479914|NCT00138671|144485920|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.664||||||90.0|-2.968|-0.36||||||Week 39||-0.360|-2.968|
72479915|NCT00138671|144485920|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.116||||||90.0|-3.829|-0.403||||||Week 50||-0.403|-3.829|
72479916|NCT00138671|144485920|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.801||||||90.0|-3.204|-0.397||||||Week 51||-0.397|-3.204|
72479917|NCT00138671|144485920|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.026||||||90.0|-3.384|-0.668||||||Week 52||-0.668|-3.384|
72479918|NCT00138671|144485920|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.451||||||90.0|-3.003|0.101||||||Week 52 LOCF||0.101|-3.003|
72479919|NCT01831856|144485938|SUPERIORITY||Hazard Ratio (HR)|1.14||||0.5749|TWO_SIDED|95.0|0.71|1.85|||Log Rank|||The primary criterion, time to first Atrial Fibrillation (AF) recurrence or atrial flutter emergence, was described using survival curves according to the Kaplan-Meier method, reporting the first and third quartiles (Q1, Q3), median, and 95% confidence interval. The time to first AF recurrence or atrial flutter emergence was compared between treatment groups using the Log rank test. Hazard ratios and 95% confidence intervals were estimated with the Cox regression model.||1.85|0.71|0.5749
72479920|NCT01078675|144485949|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-42.88|STANDARD_DEVIATION|18.222|<|0.001|TWO_SIDED|-42.88|-45.44|-40.32||P-value\<0.001 at Month 24. No adjustment for multiple comparisons is made for individual age group.|ANCOVA|P-value is two-sided and based on ANCOVA using age group as the fixed factor, and study centre and the baseline value as covariates.||||-40.32|-45.44|<0.001
72509714|NCT06150573|144550126|SUPERIORITY||Adjusted Mean Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.02||0.0957|TWO_SIDED|95.0|-0.07|0.01|||ANOVA|||Mean Gingival MLSI, Week 24||0.01|-0.07|0.0957
72509715|NCT06150573|144550126|SUPERIORITY||Adjusted Mean Difference|-0.34|STANDARD_ERROR_OF_MEAN|0.122||0.0063|TWO_SIDED|95.0|-0.58|-0.1|||ANOVA|||Mean Interproximal MLSI, Week 12||-0.10|-0.58|0.0063
72509716|NCT06150573|144550126|SUPERIORITY||Adjusted Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.147|<|0.0001|TWO_SIDED|95.0|-0.89|-0.31|||ANOVA|||Mean Interproximal MLSI, Week 24||-0.31|-0.89|<0.0001
72509717|NCT06150573|144550126|SUPERIORITY||Adjusted Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.01||0.1536|TWO_SIDED|95.0|-0.03|0.01|||ANOVA|||Mean Body MLSI, Week 12||0.01|-0.03|0.1536
72509718|NCT06150573|144550126|SUPERIORITY||Adjusted Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.006||0.1166|TWO_SIDED|95.0|-0.02|0.0|||ANOVA|||Mean Body MLSI, Week 24||0.00|-0.02|0.1166
72623671|NCT00023595|144778165|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.74|||<|0.001|TWO_SIDED|95.0|0.64|0.85|||Log Rank||Hazard Ratio is for (H01: Medication +CABG) versus (H01: Medication)|||0.85|0.64|<0.001
72623672|NCT00023595|144778166|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.72|||<|0.001|TWO_SIDED|95.0|0.64|0.82|||Log Rank||Hazard Ratio is for (H01: Medication +CABG) versus (H01: Medication)|||0.82|0.64|<0.001
72623673|NCT00023595|144778167|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.0||||0.98|TWO_SIDED|95.0|0.79|1.26|||Log Rank||Hazard Ratio is for (H02: Medication + CABG + SVR) versus (H02: Medication + CABG)|||1.26|0.79|0.98
72623674|NCT00023595|144778168|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|3.19||||0.008|TWO_SIDED|95.0|1.35|7.52|||Regression, Logistic||Odds Ratio is for (H01: Medication +CABG) versus (H01: Medication)|||7.52|1.35|0.008
72509719|NCT06150573|144550127|SUPERIORITY||Adjusted Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.035|<|0.0001|TWO_SIDED|95.0|-0.21|-0.07|||ANOVA|||Week 12||-0.07|-0.21|<0.0001
72509720|NCT06150573|144550127|SUPERIORITY||Adjusted Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.038|<|0.0001|TWO_SIDED|95.0|-0.25|-0.1|||ANOVA|||Week 24||-0.10|-0.25|<0.0001
72509721|NCT06150573|144550128|SUPERIORITY||Adjusted Mean Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.033||0.04|TWO_SIDED|95.0|-0.13|0.0|||ANOVA|||Week 12||-0.00|-0.13|0.0400
72509722|NCT06150573|144550128|SUPERIORITY||Adjusted Mean Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.037||0.001|TWO_SIDED|95.0|-0.2|-0.05|||ANOVA|||Week 24||-0.05|-0.20|0.0010
72509723|NCT00069095|144550129|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was demonstrated if the upper limit of the 2-sided 97.5% confidence interval (CI) for the hazard ratio (HR) was less than the predefined limit of 1.23 (the non-inferiority margin). A stratified Cox model was used. In order to retain an experiment-wise two-sided type I error of 5%, the non-inferiority analysis for PFS used a two-sided significance level of 2.5%.|Hazard Ratio (HR)|1.05|||||TWO_SIDED|97.5|0.94|1.18||||||Equivalence of treatment arm A ('XELOX') to treatment arm B ('FOLFOX-4') was tested via the following hypotheses - H0: HRA/B \>/= 1.23 versus H1: HRA/B \< 1.23. HRA/B denotes the hazard of disease progression or death under treatment A ('XELOX') divided by the hazard of disease progression or death under treatment B ('FOLFOX-4').||1.18|0.94|
72509724|NCT00069095|144550130|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was demonstrated if the upper limit of the 2-sided 97.5% confidence interval (CI) for the hazard ratio (HR) was less than the predefined limit of 1.23 (the non-inferiority margin). A stratified Cox model was used. In order to retain an experiment-wise two-sided type I error of 5%, the non-inferiority analysis for PFS used a two-sided significance level of 2.5%.|Hazard Ratio (HR)|1.22|||||TWO_SIDED|97.5|1.05|1.42||||||Equivalence of treatment arm A ('XELOX') to treatment arm B ('FOLFOX-4') was tested via the following hypotheses - H0: HRA/B \>/= 1.23 versus H1: HRA/B \< 1.23. HRA/B denotes the hazard of disease progression or death under treatment A ('XELOX') divided by the hazard of disease progression or death under treatment B ('FOLFOX-4').||1.42|1.05|
72509725|NCT00069095|144550131|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.7|||<|0.0001|TWO_SIDED|97.5|0.58|0.83|||Log Rank|||Testing for superiority was based on the stratified log-rank test and used a two-sided significance level of 2.5%.The hazard ratio (HR) of bevacizumab in combination with chemotherapy versus chemotherapy alone \[HR(FOLFOX-4+P/XELOX+P)/(FOLFOX-4+BV/XELOX+BV)\] was presented.||0.83|0.58|<0.0001
72509726|NCT00069095|144550132|NON_INFERIORITY_OR_EQUIVALENCE|Fewer events were expected in the 'on-treatment analysis', thus leading to reduced power. No formal statistical testing was therefore applied.|Hazard Ratio (HR)|1.24|||||TWO_SIDED|97.5|1.07|1.44||||||HRs and 97.5% confidence interval were reported for treatment arm A (XELOX/XELOX+P/XELOX+BV) versus treatment arm B (FOLFOX-4/FOLFOX-4+P/FOLFOX-4+BV).||1.44|1.07|
72509727|NCT00069095|144550133|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.63|||<|0.0001|TWO_SIDED|97.5|0.52|0.75|||Log Rank|||Testing for superiority was based on the stratified log-rank test and used a two-sided significance level of 2.5%.The hazard ratio (HR) of bevacizumab in combination with chemotherapy versus chemotherapy alone \[HR(FOLFOX-4+P/XELOX+P)/(FOLFOX-4+BV/XELOX+BV)\] was presented.||0.75|0.52|<0.0001
72509728|NCT00069095|144550134|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was demonstrated if the upper limit of the 2-sided 97.5% confidence interval (CI) for the hazard ratio (HR) was less than the predefined limit of 1.23 (the non-inferiority margin). A stratified Cox model was used. In order to retain an experiment-wise two-sided type I error of 5%, the non-inferiority analysis for PFS used a two-sided significance level of 2.5%.|Hazard Ratio (HR)|1.03|||||TWO_SIDED|97.5|0.92|1.15||||||Equivalence of treatment arm A ('XELOX') to treatment arm B ('FOLFOX-4') was tested via the following hypotheses - H0: HRA/B \>/= 1.23 versus H1: HRA/B \< 1.23. HRA/B denotes the hazard of disease progression or death under treatment A ('XELOX') divided by the hazard of disease progression or death under treatment B ('FOLFOX-4').||1.15|0.92|
72509729|NCT00069095|144550135|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.83||||0.0015|TWO_SIDED|97.5|0.72|0.95|||Log Rank|||Testing for superiority was based on the stratified log-rank test and used a two-sided significance level of 2.5%.The hazard ratio (HR) of bevacizumab in combination with chemotherapy versus chemotherapy alone \[HR(FOLFOX-4+P/XELOX+P)/(FOLFOX-4+BV/XELOX+BV)\] was presented.||0.95|0.72|0.0015
72509730|NCT00069095|144550136|NON_INFERIORITY_OR_EQUIVALENCE|This study was not powered for testing non-inferiority of XELOX vs FOLFOX-4 with respect to overall survival and no margin could be derived following the effect retention concept. The same margins used for the PFS analysis \[Non-inferiority was demonstrated if the upper limit of the 2-sided 97.5% confidence interval (CI) for the hazard ratio (HR) was less than the predefined limit of 1.23 (the non-inferiority margin)\] were therefore applied to OS as well.|Hazard Ratio (HR)|0.97|||||TWO_SIDED|97.5|0.84|1.14||||||HRs and 97.5% confidence interval were reported for treatment arm A (XELOX/XELOX+P/XELOX+BV) versus treatment arm B (FOLFOX-4/FOLFOX-4+P/FOLFOX-4+BV).||1.14|0.84|
72509731|NCT00069095|144550137|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.89||||0.1921|TWO_SIDED|97.5|0.72|1.09|||Log Rank|||Testing for superiority was based on the stratified log-rank test and used a two-sided significance level of 2.5%.The hazard ratio (HR) of bevacizumab in combination with chemotherapy versus chemotherapy alone \[HR(FOLFOX-4+P/XELOX+P)/(FOLFOX-4+BV/XELOX+BV)\] was presented together with the 97.5% confidence interval.||1.09|0.72|0.1921
72509732|NCT00069095|144550138|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.83||||0.0023|TWO_SIDED|97.5|0.72|0.95|||Log Rank|||Testing for superiority was based on the stratified log-rank test and used a two-sided significance level of 2.5%.The hazard ratio (HR) of bevacizumab in combination with chemotherapy versus chemotherapy alone \[HR(FOLFOX-4+P/XELOX+P)/(FOLFOX-4+BV/XELOX+BV)\] was presented.||0.95|0.72|0.0023
72509733|NCT00069095|144550139|NON_INFERIORITY_OR_EQUIVALENCE|The analysis was based on the two-sided 97.5% confidence interval for OR(XELOX/XELOX+P/XELOX+BV)/(FOLFOX-4/FOLFOX-4+P/FOLFOX-4+BV). Non-inferiority of XELOX with/without bevacizumab to FOLFOX-4 with/without bevacizumab was concluded if the lower limit of this confidence interval is above 0.66.|Odds Ratio (OR)|0.89|||||TWO_SIDED|97.5|0.72|1.09||||||Non-inferiority of XELOX with/without bevacizumab to FOLFOX-4 with/without bevacizumab was tested by the pair of hypotheses - H0: OR(XELOX/XELOX+P/XELOX+BV)/(FOLFOX-4/FOLFOX-4+P/FOLFOX-4+BV) \</= 0.66 versus H1: OR(XELOX/XELOX+P/XELOX+BV)/(FOLFOX-4/FOLFOX-4+P/FOLFOX-4+BV) \> 0.66, where OR denotes Odds ratio.||1.09|0.72|
72509734|NCT00069095|144550140|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.9||||0.3091|TWO_SIDED|97.5|0.71|1.14|||Chi-squared|||Superiority of adding bevacizumab to chemotherapy was tested as follows - H0: OR(FOLFOX-4+BV/XELOX+BV)/(FOLFOX-4+P/XELOX+P) \</= 1.0 versus H1: OR(FOLFOX-4+BV/XELOX+BV)/(FOLFOX-4+P/XELOX+P) \> 1.0. The test used a two-sided significance level of 2.5%.||1.14|0.71|0.3091
72509735|NCT00069095|144550141|NON_INFERIORITY_OR_EQUIVALENCE|The analysis was based on the two-sided 97.5% confidence interval for OR(XELOX/XELOX+P/XELOX+BV)/(FOLFOX-4/FOLFOX-4+P/FOLFOX-4+BV). Non-inferiority of XELOX with/without bevacizumab to FOLFOX-4 with/without bevacizumab shall be concluded if the lower limit of this confidence interval is above 0.66.|Odds Ratio (OR)|0.94|||||TWO_SIDED|97.5|0.76|1.16||||||Non-inferiority of XELOX with/without bevacizumab to FOLFOX-4 with/without bevacizumab was tested by the pair of hypotheses - H0: OR(XELOX/XELOX+P/XELOX+BV)/(FOLFOX-4/FOLFOX-4+P/FOLFOX-4+BV) \</= 0.66 versus H1: OR(XELOX/XELOX+P/XELOX+BV)/(FOLFOX-4/FOLFOX-4+P/FOLFOX-4+BV) \> 0.66||1.16|0.76|
72509736|NCT00069095|144550142|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.0||||0.9887|TWO_SIDED|97.5|0.78|1.28|||Chi-squared|||Superiority of adding bevacizumab to chemotherapy was tested as follows - H0: OR(FOLFOX-4+BV/XELOX+BV)/(FOLFOX 4+P/XELOX+P) \</= 1.0 versus H1: OR(FOLFOX-4+BV/XELOX+BV)/(FOLFOX-4+P/XELOX+P) \> 1.0. The test used a two-sided significance level of 2.5%||1.28|0.78|0.9887
72509737|NCT00069095|144550143|NON_INFERIORITY_OR_EQUIVALENCE|No formal statistical testing was done.|Hazard Ratio (HR)|1.08|||||TWO_SIDED|97.5|0.97|1.2||||||General approach: HRs and 97.5% confidence interval were reported for treatment arm A (XELOX/XELOX+P/XELOX+BV) versus treatment arm B (FOLFOX-4/FOLFOX-4+P/FOLFOX-4+BV)||1.20|0.97|
72509738|NCT00069095|144550143|NON_INFERIORITY_OR_EQUIVALENCE|Fewer events were expected in analyses using the on-treatment approach than in the analyses using the general approach, thus leading to reduced power.Therefore, no formal statistical testing was performed.|Hazard Ratio (HR)|1.1|||||TWO_SIDED|97.5|0.98|1.23||||||On-treatment Approach: HRs and 97.5% confidence interval were reported for treatment arm A (XELOX/XELOX+P/XELOX+BV) versus treatment arm B (FOLFOX-4/FOLFOX-4+P/FOLFOX-4+BV).||1.23|0.98|
72509739|NCT00069095|144550144|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.84||||0.003|TWO_SIDED|97.5|0.74|0.96|||Log Rank|||General approach: Testing for superiority was based on the stratified log-rank test and used a two-sided significance level of 2.5%.The hazard ratio (HR) of bevacizumab in combination with chemotherapy versus chemotherapy alone \[HR(FOLFOX-4+P/XELOX+P)/(FOLFOX-4+BV/XELOX+BV)\] was presented.||0.96|0.74|0.0030
72566628|NCT00474851|144663581|SUPERIORITY_OR_OTHER|||||||0.1|TWO_SIDED|||||p (within group for subjects receiving norethindrone + conjugated estrogens)=0.05 p (within group for subjects receiving norethindrone + placebo)=0.65 p (between the two groups)=0.10|RMANOVA|||"Analysis followed the intention-to-treat principle. The time course of each measurement from baseline to 3, 6, 9, and 12 months was compared between arms by repeated-measures analysis of variance (RM-ANOVA), with an autoregressive covariance model to account for visit-to-visit correlation within subjects.~The primary test of treatment efficacy was time × treatment interaction. Adjusted changes over time and differences between trial arms were constructed from parameters of the RMANOVA."||||0.10
72576861|NCT00261443|144680664|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.24||||0.141|TWO_SIDED|95.0|-0.56|0.08||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 16 Comparison||0.08|-0.56|0.141
72509740|NCT00069095|144550144|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.81||||0.0004|TWO_SIDED|97.5|0.7|0.92|||Log Rank|||On treatment approach: Testing for superiority was based on the stratified log-rank test and used a two-sided significance level of 2.5%.The hazard ratio (HR) of bevacizumab in combination with chemotherapy versus chemotherapy alone \[HR(FOLFOX-4+P/XELOX+P)/(FOLFOX-4+BV/XELOX+BV)\] was presented.||0.92|0.70|0.0004
72509741|NCT00069095|144550147|NON_INFERIORITY_OR_EQUIVALENCE|No formal statistical testing was performed for duration of overall response.|Hazard Ratio (HR)|1.02|||||TWO_SIDED|97.5|0.86|1.22||||||HRs and 97.5% confidence interval were reported for treatment arm A (XELOX/XELOX+P/XELOX+BV) versus treatment arm B (FOLFOX-4/FOLFOX-4+P/FOLFOX-4+BV)||1.22|0.86|
72509742|NCT00069095|144550148|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.82||||0.0307|TWO_SIDED|97.5|0.66|1.01|||Log Rank|||Testing for superiority was based on the stratified log-rank test and used a two-sided significance level of 2.5%.The hazard ratio (HR) of bevacizumab in combination with chemotherapy versus chemotherapy alone \[HR(FOLFOX-4+P/XELOX+P)/(FOLFOX-4+BV/XELOX+BV)\] was presented.||1.01|0.66|0.0307
72509743|NCT00069095|144550149|NON_INFERIORITY_OR_EQUIVALENCE|No formal statistical testing was done.|Hazard Ratio (HR)|0.35|||||TWO_SIDED|97.5|0.09|1.39||||||HRs and 97.5% confidence interval were reported for treatment arm A (XELOX/XELOX+P/XELOX+BV) versus treatment arm B (FOLFOX-4/FOLFOX-4+P/FOLFOX-4+BV).||1.39|0.09|
72509744|NCT00069095|144550150|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.2||||0.8207|TWO_SIDED|97.5|0.2|7.05|||Log Rank|||Testing for superiority was based on the stratified log-rank test and used a two-sided significance level of 2.5%.The hazard ratio (HR) of bevacizumab in combination with chemotherapy versus chemotherapy alone \[HR(FOLFOX-4+P/XELOX+P)/(FOLFOX-4+BV/XELOX+BV)\] was presented.||7.05|0.20|0.8207
72509745|NCT00210158|144550165|SUPERIORITY||Mean Difference (Final Values)|9.7||||0.5|TWO_SIDED|95.0|-23.4|42.8|||t-test, 2 sided|||T-test for a difference of means, assuming independant samples and unequal variances||42.8|-23.4|0.5
72509746|NCT04716933|144550167|OTHER||Hazard Ratio (HR)|0.68|||||TWO_SIDED|95.0|0.48|0.97||||||Based on Cox regression model with Efron's method of tie handling with treatment as a covariate||0.97|0.48|
72509747|NCT04716933|144550168|OTHER||Hazard Ratio (HR)|0.78|||||TWO_SIDED|95.0|0.54|1.12||||||Based on Cox regression model with Efron's method of tie handling with treatment as a covariate||1.12|0.54|
72509748|NCT04716933|144550169|OTHER||Percent Difference|11.3|||||TWO_SIDED|95.0|-2.0|24.2||||||Comparision based on unstratified Miettinen \& Nurminen method||24.2|-2.0|
72509749|NCT01005719|144550180|SUPERIORITY_OR_OTHER|||||||0.0242||95.0||||p-value for 10-15 mins Post-dose on Day 7. No adjustments were made for multiple comparisons. P-values \<= 0.05 were reported as statistically significant.|Wilcoxon (Mann-Whitney)|||||||0.0242
72509750|NCT01005719|144550180|SUPERIORITY_OR_OTHER|||||||0.027||95.0||||p-value for 15-20 mins Post-dose on Day 7. No adjustments were made for multiple comparisons. P-values \<= 0.05 were reported as statistically significant.|Wilcoxon (Mann-Whitney)|||||||0.0270
72509751|NCT01005719|144550180|SUPERIORITY_OR_OTHER|||||||0.0067||95.0||||p-value for 20-25 mins Post-dose on Day 7. No adjustments were made for multiple comparisons. P-values \<= 0.05 were reported as statistically significant.|Wilcoxon (Mann-Whitney)|||||||0.0067
72509752|NCT01005719|144550181|SUPERIORITY_OR_OTHER|||||||0.0465||95.0||||p-value for 10-15 mins Post-dose on Day 1|Wilcoxon (Mann-Whitney)|||||||0.0465
72400534|NCT00975481|144308991|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.0725||||0.4255|TWO_SIDED|95.0|-3.0533|7.1984|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emin, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||7.1984|-3.0533|0.4255
72400535|NCT00975481|144308991|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3425||||0.8959|TWO_SIDED|95.0|-5.5053|4.8204|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emin, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||4.8204|-5.5053|0.8959
72509753|NCT01005719|144550181|SUPERIORITY_OR_OTHER|||||||0.0012||95.0||||p-value for 15-20 mins Post-dose on Day 1|Wilcoxon (Mann-Whitney)|||||||0.0012
72509754|NCT01005719|144550181|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||p-value for 20-25 mins Post-dose on Day 1|Wilcoxon (Mann-Whitney)|||||||<0.0001
72400536|NCT00975481|144308991|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.3224||||0.1967|TWO_SIDED|95.0|-1.7402|8.385|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emin, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||8.3850|-1.7402|0.1967
72400537|NCT00975481|144308991|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.5264||||0.1733|TWO_SIDED|95.0|-1.5676|8.6203|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emin, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||8.6203|-1.5676|0.1733
72509755|NCT01005719|144550182|SUPERIORITY_OR_OTHER||||||<|0.05||95.0||||The statistical analysis is for Day 1 (0-5 mins).|Wilcoxon (Mann-Whitney)|||||||<0.05
72509756|NCT01005719|144550182|SUPERIORITY_OR_OTHER||||||<|0.05||95.0||||The statistical analysis is for Day 1 (0-5 mins).|Wilcoxon (Mann-Whitney)|||||||<0.05
72623675|NCT00023595|144778169|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.37||||0.275|TWO_SIDED|95.0|0.78|2.41|||Regression, Logistic||Odds Ratio is for (H02: Medication + CABG + SVR) versus (H02: Medication + CABG)|||2.41|0.78|0.275
72400538|NCT00975481|144308991|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.1113||||0.6697|TWO_SIDED|95.0|-4.0285|6.2512|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emin, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||6.2512|-4.0285|0.6697
72509757|NCT01005719|144550182|SUPERIORITY_OR_OTHER||||||<|0.05||95.0||||The statistical analysis is for Day 7 (0-5 mins).|Wilcoxon (Mann-Whitney)|||||||<0.05
72509758|NCT01005719|144550182|SUPERIORITY_OR_OTHER||||||<|0.05||95.0||||The statistical analysis is for Day 7 (0-5 mins).|Wilcoxon (Mann-Whitney)|||||||<0.05
72509759|NCT05187013|144550271|SUPERIORITY||Mean Difference (Net)|-7.16|STANDARD_ERROR_OF_MEAN|2.72||0.006|TWO_SIDED|95.0|-12.59|-1.73|||t-test, 1 sided|||Null Hypothesis: No improvement between baseline and final SBP, i.e., Final SBP - Baseline SBP \>= 0 Alternative Hypothesis: Final SBP - Baseline SBP \<0 Power calculation: Based on the data, the mean and SD of the change in SBP are -7.16 and 21.40, respectively. Using a one-sided paired t-test with a significance level of 0.05, we should have a power of 83.16%||-1.73|-12.59|0.006
72509760|NCT05187013|144550271|SUPERIORITY||Mean Difference (Net)|-2.15|STANDARD_ERROR_OF_MEAN|1.32||0.056|TWO_SIDED|95.0|-4.79|0.49|||t-test, 1 sided|||Null Hypothesis: No improvement between baseline and final DBP, i.e., Final DBP - Baseline DBP \>= 0 Alternative Hypothesis: Final DBP - Baseline DBP \<0 Power calculation: Based on the data, the mean and SD of the change in SBP are -2.15 and 10.49, respectively. Using a one-sided paired t-test with a significance level of 0.05, we should have a power of 51.48%||0.49|-4.79|0.056
72509761|NCT05187013|144550271|EQUIVALENCE|The margin was considered to be 0.|Mean Difference (Net)|-0.67|STANDARD_ERROR_OF_MEAN|4.13||0.87|TWO_SIDED|95.0|-8.76|7.42|||ANCOVA|Adjusted for baseline SBP and follow-up time|The parameter was defined as the change in SBP for the general health education arm - the change in SBP for the HTN specific education arm adjusted for follow-up time and baseline SBP|"Null hypothesis: No difference between the change in SBP between the two arms~Power calculation: With our sample size, we expect to have 80% power as long as the effect size is at least 0.72 at a 5% level."||7.42|-8.76|0.87
72509762|NCT05187013|144550271|EQUIVALENCE|The margin was taken to be 0|Mean Difference (Net)|0.98|STANDARD_ERROR_OF_MEAN|2.04||0.63|TWO_SIDED|95.0|-3.02|4.98|||ANCOVA|Adjusted for baseline DBP and follow-up time|The parameter was defined as the change in DBP for the general health education arm - the change in DBP for the HTN specific education arm adjusted for follow-up time and baseline SBP|"Null hypothesis: No difference between the change in DBP between the two arms~Power calculation: With our sample size, we expect to have 80% power as long as the effect size is at least 0.72 at a 5% level."||4.98|-3.02|0.63
72509763|NCT05187013|144550272|EQUIVALENCE|The margin is taken to be 0|Odds Ratio, log|0.89|STANDARD_ERROR_OF_MEAN|0.61||0.14|TWO_SIDED|95.0|-0.26|2.29|||Regression, Logistic|A mixed effect model with study arm as a fixed effect and subject-specific random effect.|For OR: the general education arm was taken as the baseline (denominator)|Null hypothesis: There is no difference in medicine adherence between the two groups||2.29|-0.26|0.14
72509764|NCT05187013|144550273|EQUIVALENCE|The margin was taken to be 0.|Odds Ratio, log|-0.19|STANDARD_ERROR_OF_MEAN|0.2||0.32|TWO_SIDED|95.0|-0.58|0.19|||Regression, Logistic|Binomial regression for appointment attended/appointment scheduled.|The baseline (denominator) was taken to be the general education arm.|Null hypothesis: No difference in appointment adherence between the study arms||0.19|-0.58|0.32
72509765|NCT03015610|144550291|SUPERIORITY|||||||0.8716|||||||Wilcoxon (Mann-Whitney)|||||||0.8716
72400539|NCT00975481|144308991|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.8623|||<|0.0001|TWO_SIDED|95.0|5.8712|15.8535|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emin, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||15.8535|5.8712|<0.0001
72509766|NCT03015610|144550292|SUPERIORITY|||||||0.2471|||||||Wilcoxon (Mann-Whitney)|||||||0.2471
72509767|NCT03015610|144550293|SUPERIORITY|||||||0.039|||||||Wilcoxon (Mann-Whitney)|||||||0.039
72509768|NCT03015610|144550294|SUPERIORITY|||||||0.2765|||||||Wilcoxon (Mann-Whitney)|||||||0.2765
72509769|NCT03015610|144550295|SUPERIORITY||Risk Ratio (RR)|2.32||||0.191|TWO_SIDED|95.0|0.66|8.2|||Negative binomial regression|||||8.20|0.66|0.191
72509770|NCT03015610|144550296|SUPERIORITY||Risk Ratio (RR)|0.53||||0.0435|TWO_SIDED|95.0|0.29|0.98|||Negative binomial regression|||||0.98|0.29|0.0435
72509771|NCT03015610|144550297|SUPERIORITY|||||||0.3808|||||||Wilcoxon (Mann-Whitney)|||||||0.3808
72400540|NCT00975481|144308991|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.0663|||<|0.0001|TWO_SIDED|95.0|6.0281|16.1045|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emin, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||16.1045|6.0281|<0.0001
72509772|NCT02492750|144550318|OTHER||Maximum Tolerated Dose (MTD) Level|3.0|||||TWO_SIDED||||||||MTD is defined as the dose level below the lowest dose that induces DLT in at least one-third of patients. A total of 6 patients treated at the MTD will be sufficient to identify common toxicities at the MTD.|||||
72509773|NCT04415489|144550351|SUPERIORITY|||||||0.57||||||The a priori threshold for statistical significance was p \< 0.05.|Fisher Exact|||||||0.57
72509774|NCT04415489|144550352|SUPERIORITY||||||<|0.01||||||The a priori threshold for statistical significance was p \< 0.05.|t-test, 2 sided|||||||<0.01
72509775|NCT04415489|144550353|SUPERIORITY|||||||0.11||||||The a priori threshold for statistical significance was \< 0.05.|Fisher Exact|||||||0.11
72509776|NCT04415489|144550354|SUPERIORITY|||||||0.16||||||The a priori threshold for statistical significance was \< 0.05.|t-test, 2 sided|||||||0.16
72509777|NCT04415489|144550355|SUPERIORITY||||||<|0.01||||||The a priori threshold for statistical significance was \< 0.05.|Fisher Exact|||||||< 0.01
72509778|NCT04415489|144550359|SUPERIORITY|||||||0.12||||||The a priori threshold for statistical significance was \< 0.05.|Fisher Exact|||||||0.12
72509779|NCT01193348|144550364|SUPERIORITY_OR_OTHER||Percent of Complete TMA Response|63.6|||||TWO_SIDED|95.0|40.7|82.8||||||||82.8|40.7|
72509780|NCT01193348|144550365|SUPERIORITY_OR_OTHER||Percent of Complete Hematologic Response|81.8|||||TWO_SIDED|95.0|59.7|94.8||||||||94.8|59.7|
72509781|NCT01193348|144550366|SUPERIORITY_OR_OTHER||Percent of Platelet Count Normalization|95.0|||||TWO_SIDED|95.0|77.2|99.9||||||||99.9|77.2|
72509782|NCT01193348|144550367|SUPERIORITY_OR_OTHER||Percent of eGFR Improvement|86.4|||||TWO_SIDED|95.0|65.1|97.1||||||||97.1|65.1|
72509783|NCT01193348|144550368|SUPERIORITY_OR_OTHER||LS mean change from baseline|204.96|||<|0.0001|TWO_SIDED|95.0|164.44|245.49|||ANOVA|||||245.49|164.44|<0.0001
72509784|NCT01193348|144550369|SUPERIORITY_OR_OTHER||Percent of Complete TMA Response|68.2|||||TWO_SIDED|95.0|45.1|86.1||||||||86.1|45.1|
72509785|NCT01193348|144550370|SUPERIORITY_OR_OTHER||Percent of Complete Hematologic Response|90.9|||||TWO_SIDED|95.0|70.8|98.9||||||||98.9|70.8|
72509786|NCT01193348|144550371|SUPERIORITY_OR_OTHER||Percent of Platelet Count Normalization|95.5|||||TWO_SIDED|95.0|77.2|99.9||||||||99.9|77.2|
72509787|NCT01193348|144550372|SUPERIORITY_OR_OTHER||Percent of eGFR Improvement|86.4|||||TWO_SIDED|95.0|65.1|97.1||||||||97.1|65.1|
72509788|NCT01193348|144550373|SUPERIORITY_OR_OTHER||LS mean change from baseline|165.43|||<|0.0001|TWO_SIDED|95.0|98.43|232.43|||ANOVA|||||232.43|98.43|<0.0001
72509789|NCT05319535|144550381|SUPERIORITY||Mean Difference (Final Values)|2.2||||0.26|TWO_SIDED|95.0|-1.8|6.1|||Regression, Linear|||Models included the arm indicator variable in addition to the stratification variables used in randomization (site complexity level (high complexity '1a', '1b' or '1c' vs. all others); prior implementation of Caregivers First (yes vs. no)).||6.1|-1.8|0.26
72509790|NCT05319535|144550382|SUPERIORITY||rate ratio|1.7||||0.11|TWO_SIDED|95.0|0.9|3.4|||negative binomial regression|||Models included the arm indicator variable in addition to the stratification variables used in randomization (site complexity level (high complexity '1a', '1b' or '1c' vs. all others); prior implementation of Caregivers First (yes vs. no)).||3.4|0.9|0.11
72509791|NCT05319535|144550383|SUPERIORITY||Mean Difference (Final Values)|37.6||||0.17|TWO_SIDED|95.0|-18.1|93.3|||Regression, Linear|||Models included the arm indicator variable in addition to the stratification variables used in randomization (site complexity level (high complexity '1a', '1b' or '1c' vs. all others); prior implementation of Caregivers First (yes vs. no)).||93.3|-18.1|0.17
72509792|NCT05319535|144550384|SUPERIORITY||Mean Difference (Final Values)|0.6||||0.1|TWO_SIDED|95.0|-0.1|1.4|||Regression, Linear|||Models included the arm indicator variable in addition to the stratification variables used in randomization (site complexity level (high complexity '1a', '1b' or '1c' vs. all others); prior implementation of Caregivers First (yes vs. no)).||1.4|-0.1|0.10
72509793|NCT05319535|144550385|SUPERIORITY||rate ratio|1.3||||0.36|TWO_SIDED|95.0|0.7|2.3|||negative binomial regression|||Models included the arm indicator variable in addition to the stratification variables used in randomization (site complexity level (high complexity '1a', '1b' or '1c' vs. all others); prior implementation of Caregivers First (yes vs. no)).||2.3|0.7|0.36
72509794|NCT05319535|144550386|SUPERIORITY||Odds Ratio (OR)|3.3||||0.17|TWO_SIDED|95.0|0.6|18.5|||Regression, Logistic|||Model included the arm indicator variable.||18.5|0.6|0.17
72509795|NCT03463941|144550422|OTHER||||||||||||||||||descriptive|||
72509796|NCT03463941|144550423|OTHER||||||||||||||||||descriptive|||
72509797|NCT03463941|144550425|OTHER||||||<|0.05|||||||Mixed Models Analysis|||||||<0.05
72509798|NCT03463941|144550426|OTHER||||||<|0.05|||||||Mixed Models Analysis|||||||<0.05
72509799|NCT03463941|144550427|OTHER||||||||||||||||||descriptive|||
72509800|NCT03463941|144550428|OTHER||||||<|0.05|||||||Mixed Models Analysis|||||||<0.05
72509801|NCT01725152|144550440|SUPERIORITY|||||||0.4475|||||||Linear mixed-effect|||Null hypothesis of no treatment difference in CGI-I will be assessed using a linear mixed-effects model for repeated measures, accounting for treatment (ganaxolone versus placebo) and period at a significant level of 0.05. A sample size of 30 participants in each arm/group was planned in the study will have 90% power to detect a modest effect size of 0.6 at level 0.05 in CGI-I. With a possible dropout rate of 15%, the power for testing the effect size becomes 84%.||||0.4475
72509802|NCT01111539|144550454|SUPERIORITY||Treatment Difference|-1.0|||=|0.644|TWO_SIDED|95.0|-5.2|3.3|||ANCOVA|||The statistical analyses was performed by fitting an analysis of covariance (ANCOVA) model to the change from baseline data (Week 8 Visit) for the MADRS Total Score at the Week 14 visit (LOCF). The model included baseline MADRS Total Score as a covariate and treatment as the main effect.||3.3|-5.2|=0.644
72509803|NCT01111539|144550454|SUPERIORITY||Treatment Difference|-3.7|||=|0.08|TWO_SIDED|95.0|-7.8|0.4|||ANCOVA|||The statistical analyses will be performed by fitting an ANCOVA model to the change from baseline data (Week 8 Visit) for the MADRS Total Score at the Week 14 visit (LOCF). The model will include baseline MADRS Total Score as a covariate and treatment as the main effect.||0.4|-7.8|=0.080
72509804|NCT01111539|144550455|SUPERIORITY||Treatment Difference|-0.3|||=|0.366|TWO_SIDED|95.0|-0.8|0.3|||Cochran-Mantel-Haenszel|||||0.3|-0.8|=0.366
72509805|NCT01111539|144550455|SUPERIORITY||Treatment Difference|-0.4|||=|0.138|TWO_SIDED|95.0|-0.9|0.1|||Cochran-Mantel-Haenszel|||||0.1|-0.9|=0.138
72509806|NCT01111539|144550456|SUPERIORITY||Treatment Difference|0.0|||=|0.995|TWO_SIDED|95.0|-1.2|1.2|||ANCOVA|||||1.2|-1.2|=0.995
72509807|NCT01111539|144550456|SUPERIORITY||Treatment Difference|-0.9|||=|0.118|TWO_SIDED|95.0|-2.1|0.2|||ANCOVA|||||0.2|-2.1|=0.118
72509808|NCT03628417|144550457|NON_INFERIORITY|Examined the objective response rate (ORR) that there was 20% difference between the 2 treatment arms at day 180. With a significance level of 0,05 and a power of 80% the study required 28 evaluable metastases.|Odds Ratio (OR)|0.4489629||||0.3|TWO_SIDED|95.0|-13.3|53.3|||Fisher Exact|||After reviewing existing data from electrochemotherapy with intratumoral bleomycin on small cutaneous metastases ≤3cm , we estimated the expected response rate for electrochemotherapy to 85%. We have no clinical results for the treatment of calcium electroporation, but on the basis of preclinical studies, we decided to accept a difference in response of 20%. All statistical analysis were done using IBM SPSS v24.||53.30|-13.30|0.30
72509809|NCT00372190|144550460|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Chi-squared|||||||<0.05
72509810|NCT01883440|144550478|SUPERIORITY_OR_OTHER||||||<|0.037|TWO_SIDED||||||Mixed Models Analysis|Linear mixed model||||||<0.037
72509811|NCT01883440|144550479|SUPERIORITY_OR_OTHER|||||||0.381|TWO_SIDED||||||Mixed Models Analysis|||In the material when all were included, there were a lot of persons with few symptoms in both Groups, which means that a larger study would be needed in order to detect significant differences.||||0.381
72509812|NCT01856595|144550516|SUPERIORITY_OR_OTHER||Least Square Mean Difference (Net)|-2.77|STANDARD_ERROR_OF_MEAN|8.532||0.7457|TWO_SIDED|90.0|-16.93|11.38||Two-sided p-values are from analysis of Covariance (ANCOVA) model with treatment as a factor and baseline value as a covariate. P-values are not adjusted for multiple comparisons.|ANCOVA|||Placebo was the Reference and each of the active doses was the Test.||11.38|-16.93|0.7457
72509813|NCT01856595|144550516|SUPERIORITY_OR_OTHER||Least Square Mean Difference (Net)|-21.64|STANDARD_ERROR_OF_MEAN|8.334||0.0108|TWO_SIDED|90.0|-35.47|-7.81||Two-sided p-values are from analysis of Covariance (ANCOVA) model with treatment as a factor and baseline value as a covariate. P-values are not adjusted for multiple comparisons.|ANCOVA|||Placebo was the Reference and each of the active doses was the Test.||-7.81|-35.47|0.0108
72509814|NCT01856595|144550516|SUPERIORITY_OR_OTHER||Least Square Mean Difference (Net)|-26.59|STANDARD_ERROR_OF_MEAN|8.309||0.0018|TWO_SIDED|90.0|-40.38|-12.8||Two-sided p-values are from analysis of Covariance (ANCOVA) model with treatment as a factor and baseline value as a covariate. P-values are not adjusted for multiple comparisons.|ANCOVA|||Placebo was the Reference and each of the active doses was the Test.||-12.80|-40.38|0.0018
72509815|NCT01856595|144550516|SUPERIORITY_OR_OTHER||Least Square Mean Difference (Net)|-32.33|STANDARD_ERROR_OF_MEAN|8.038||0.0001|TWO_SIDED|90.0|-45.66|-18.99||Two-sided p-values are from analysis of Covariance (ANCOVA) model with treatment as a factor and baseline value as a covariate. P-values are not adjusted for multiple comparisons.|ANCOVA|||Placebo was the Reference and each of the active doses was the Test.||-18.99|-45.66|0.0001
72509816|NCT01856595|144550516|SUPERIORITY_OR_OTHER||Least Square Mean Difference (Net)|-42.39|STANDARD_ERROR_OF_MEAN|8.34|<|0.0001|TWO_SIDED|90.0|-56.23|-28.55||Two-sided p-values are from analysis of Covariance (ANCOVA) model with treatment as a factor and baseline value as a covariate. P-values are not adjusted for multiple comparisons.|ANCOVA|||Placebo was the Reference and each of the active doses was the Test.||-28.55|-56.23|<0.0001
72509817|NCT01856595|144550517|SUPERIORITY_OR_OTHER||Least Square Mean Difference (Net)|10.47|STANDARD_ERROR_OF_MEAN|9.621||0.279|TWO_SIDED|90.0|-5.5|26.43||Two-sided p-values are from ANCOVA model with treatment as a factor and baseline value as a covariate. P-values are not adjusted for multiple comparisons.|ANCOVA|||Placebo was the Reference and each of the active doses was the Test.||26.43|-5.50|0.2790
72509818|NCT01856595|144550517|SUPERIORITY_OR_OTHER||Least Square Mean Difference (Net)|-19.33|STANDARD_ERROR_OF_MEAN|8.777||0.0299||90.0|-33.89|-4.76||Two-sided p-values are from ANCOVA model with treatment as a factor and baseline value as a covariate. P-values are not adjusted for multiple comparisons.|ANCOVA|||Placebo was the Reference and each of the active doses was the Test.||-4.76|-33.89|0.0299
72623676|NCT00023595|144778170|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.84||||0.03|TWO_SIDED|95.0|0.71|0.98|||Log Rank||Hazard Ratio is for (H01: Medication +CABG) versus (H01: Medication)|||0.98|0.71|0.030
72623677|NCT00023595|144778171|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.08||||0.401|TWO_SIDED|95.0|0.89|1.31|||Log Rank||Hazard Ratio is for (H02: Medication + CABG + SVR) versus (H02: Medication + CABG)|||1.31|0.89|0.401
72623678|NCT00023595|144778172|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.81||||0.002|TWO_SIDED|95.0|0.71|0.93|||Log Rank||Hazard Ratio is for (H01: Medication +CABG) versus (H01: Medication)|||0.93|0.71|0.002
72623679|NCT00023595|144778188|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.6|||<|0.001|TWO_SIDED|95.0|0.51|0.71|||Log Rank||Hazard Ratio is for (H01: Medication +CABG) versus (H01: Medication)|||0.71|0.51|<0.001
72623680|NCT00023595|144778189|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.91||||0.414|TWO_SIDED|95.0|0.73|1.13|||Log Rank||Hazard Ratio is for (H02: Medication + CABG + SVR) versus (H02: Medication + CABG)|||1.13|0.73|0.414
72509819|NCT01856595|144550518|SUPERIORITY_OR_OTHER||Least Square Mean Difference (Net)|-29.43|STANDARD_ERROR_OF_MEAN|7.609||0.0005|TWO_SIDED|90.0|-42.28|-16.57||Two-sided p-values are from analysis of Covariance (ANCOVA) model with treatment as a factor and baseline value as a covariate. P-values are not adjusted for multiple comparisons.|ANCOVA|||Placebo was the Reference and each of the active doses was the Test.||-16.57|-42.28|0.0005
72509820|NCT01856595|144550518|SUPERIORITY_OR_OTHER||Least Square Mean Difference (Net)|-11.89|STANDARD_ERROR_OF_MEAN|7.321||0.1133|TWO_SIDED|90.0|-24.26|0.48||Two-sided p-values are from analysis of Covariance (ANCOVA) model with treatment as a factor and baseline value as a covariate. P-values are not adjusted for multiple comparisons.|ANCOVA|||Placebo was the Reference and each of the active doses was the Test.||0.48|-24.26|0.1133
72509821|NCT01856595|144550519|SUPERIORITY_OR_OTHER||Ratio|0.99|STANDARD_ERROR_OF_MEAN|1.066||0.853|TWO_SIDED|90.0|0.89|1.1||Two-sided p-values are from analysis of Covariance (ANCOVA) model with treatment as a factor and baseline value as a covariate using the natural log-transformed AUC0-4. P-values are not adjusted for multiple comparisons.|ANCOVA|||Placebo was the Reference and each of the active doses was the Test.||1.10|0.89|0.8530
72509822|NCT01856595|144550519|SUPERIORITY_OR_OTHER||Ratio|0.86|STANDARD_ERROR_OF_MEAN|1.065||0.0172|TWO_SIDED|90.0|0.77|0.95||Two-sided p-values are from analysis of Covariance (ANCOVA) model with treatment as a factor and baseline value as a covariate using the natural log-transformed AUC0-4. P-values are not adjusted for multiple comparisons.|ANCOVA|||Placebo was the Reference and each of the active doses was the Test.||0.95|0.77|0.0172
72509823|NCT01856595|144550519|SUPERIORITY_OR_OTHER||Ratio|0.85|STANDARD_ERROR_OF_MEAN|1.064||0.0106|TWO_SIDED|90.0|0.77|0.94||Two-sided p-values are from analysis of Covariance (ANCOVA) model with treatment as a factor and baseline value as a covariate using the natural log-transformed AUC0-4. P-values are not adjusted for multiple comparisons.|ANCOVA|||Placebo was the Reference and each of the active doses was the Test.||0.94|0.77|0.0106
72509824|NCT01856595|144550519|SUPERIORITY_OR_OTHER||Ratio|0.82|STANDARD_ERROR_OF_MEAN|1.062||0.0012|TWO_SIDED|90.0|0.74|0.9||Two-sided p-values are from analysis of Covariance (ANCOVA) model with treatment as a factor and baseline value as a covariate using the natural log-transformed AUC0-4. P-values are not adjusted for multiple comparisons.|ANCOVA|||Placebo was the Reference and each of the active doses was the Test.||0.90|0.74|0.0012
72509825|NCT01856595|144550519|SUPERIORITY_OR_OTHER||Ratio|0.77|STANDARD_ERROR_OF_MEAN|1.065|<|0.0001|TWO_SIDED|90.0|0.69|0.85||Two-sided p-values are from analysis of Covariance (ANCOVA) model with treatment as a factor and baseline value as a covariate using the natural log-transformed AUC0-4. P-values are not adjusted for multiple comparisons.|ANCOVA|||Placebo was the Reference and each of the active doses was the Test.||0.85|0.69|<0.0001
72509826|NCT01856595|144550520|SUPERIORITY_OR_OTHER||Ratio|0.98|STANDARD_ERROR_OF_MEAN|1.075||0.7804|TWO_SIDED|90.0|0.87|1.1||Two-sided p-values are from analysis of ANCOVA model with treatment as a factor and baseline value as a covariate using the natural log-transformed AUC0-4. P-values are not adjusted for multiple comparisons.|ANCOVA|||Placebo was the Reference and each of the active doses was the Test.||1.10|0.87|0.7804
72509827|NCT01856595|144550520|SUPERIORITY_OR_OTHER||Ratio|0.88|STANDARD_ERROR_OF_MEAN|1.068||0.0908|TWO_SIDED|90.0|0.77|1.0||Two-sided p-values are from ANCOVA model with treatment as a factor and baseline value as a covariate using the natural log-transformed AUC0-4. P-values are not adjusted for multiple comparisons.|ANCOVA|||Placebo was the Reference and each of the active doses was the Test.||1.00|0.77|0.0908
72509828|NCT01856595|144550521|SUPERIORITY_OR_OTHER||Ratio|0.77|STANDARD_ERROR_OF_MEAN|1.083||0.0027|TWO_SIDED|90.0|0.68|0.88||Two-sided p-values are from ANCOVA model with treatment as a factor and baseline value as a covariate using the natural log-transformed AUC0-4. P-values are not adjusted for multiple comparisons.|ANCOVA|||Placebo was the Reference and each of the active doses was the Test.||0.88|0.68|0.0027
72623681|NCT00023595|144778190|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.63|||<|0.001|TWO_SIDED|95.0|0.55|0.73|||Log Rank||Hazard Ratio is for (H01: Medication +CABG) versus (H01: Medication)|||0.73|0.55|<0.001
72509829|NCT01856595|144550521|SUPERIORITY_OR_OTHER||Ratio|0.88|STANDARD_ERROR_OF_MEAN|1.079||0.0908|TWO_SIDED|90.0|0.77|1.0||Two-sided p-values are from ANCOVA model with treatment as a factor and baseline value as a covariate using the natural log-transformed AUC0-4. P-values are not adjusted for multiple comparisons.|ANCOVA|||Placebo was the Reference and each of the active doses was the Test.||1.00|0.77|0.0908
72509830|NCT01856595|144550525|SUPERIORITY_OR_OTHER||Ratio|0.98|STANDARD_ERROR_OF_MEAN|1.123||0.8723|TWO_SIDED|90.0|0.81|1.19||Two-sided p-values are from ANCOVA model with treatment as a factor and baseline value as a covariate using the natural log-transformed AUC0-4. P-values are not adjusted for multiple comparisons.|ANCOVA|||Placebo was the Reference and each of the active doses was the Test.||1.19|0.81|0.8723
72509831|NCT01856595|144550525|SUPERIORITY_OR_OTHER||Ratio|0.93|STANDARD_ERROR_OF_MEAN|1.124||0.5158|TWO_SIDED|90.0|0.76|1.13||Two-sided p-values are from ANCOVA model with treatment as a factor and baseline value as a covariate using the natural log-transformed AUC0-4. P-values are not adjusted for multiple comparisons.|ANCOVA|||Placebo was the Reference and each of the active doses was the Test.||1.13|0.76|0.5158
72509832|NCT01856595|144550525|SUPERIORITY_OR_OTHER||Ratio|0.83|STANDARD_ERROR_OF_MEAN|1.126||0.1258|TWO_SIDED|90.0|0.68|1.01||Two-sided p-values are from ANCOVA model with treatment as a factor and baseline value as a covariate using the natural log-transformed AUC0-4. P-values are not adjusted for multiple comparisons.|ANCOVA|||Placebo was the Reference and each of the active doses was the Test.||1.01|0.68|0.1258
72509833|NCT01856595|144550525|SUPERIORITY_OR_OTHER||Ratio|0.89|STANDARD_ERROR_OF_MEAN|1.115||0.2883|TWO_SIDED|90.0|0.74|1.07||Two-sided p-values are from ANCOVA model with treatment as a factor and baseline value as a covariate using the natural log-transformed AUC0-4. P-values are not adjusted for multiple comparisons.|ANCOVA|||Placebo was the Reference and each of the active doses was the Test.||1.07|0.74|0.2883
72509834|NCT01856595|144550525|SUPERIORITY_OR_OTHER||Ratio|0.98|STANDARD_ERROR_OF_MEAN|1.12||0.8437|TWO_SIDED|90.0|0.81|1.18||Two-sided p-values are from ANCOVA model with treatment as a factor and baseline value as a covariate using the natural log-transformed AUC0-4. P-values are not adjusted for multiple comparisons.|ANCOVA|||Placebo was the Reference and each of the active doses was the Test.||1.18|0.81|0.8437
72623682|NCT00023595|144778191|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.86||||0.108|TWO_SIDED|95.0|0.72|1.03|||Log Rank||Hazard Ratio is for (H01: Medication +CABG) versus (H01: Medication)|||1.03|0.72|0.108
72479921|NCT01191268|144485974|NON_INFERIORITY_OR_EQUIVALENCE|If the upper limit of the 95% Confidence Interval (CI) of 1.5 mg LY2189265 versus Insulin Glargine was below 0.4%, 1.5 mg LY2189265 was declared non-inferior to Insulin Glargine.|LS Mean Difference|-0.22|||<|0.001|TWO_SIDED|95.0|-0.38|-0.07||Family-wise Type I error rate was controlled by applying tree-gatekeeping strategy.|ANCOVA|||The study was designed to enroll 837 randomized participants (279 per treatment arm) with 90% power to detect non-inferiority of 1.5 mg LY2189265 versus Insulin Glargine on HbA1c change from baseline at the 26-week primary endpoint with a margin of 0.4%, a standard deviation of 1.3%, and a 1-sided alpha of 0.025 assuming no true difference between treatments. This corresponds to 248 participants per arm, with an assumed drop-out rate of 11%.||-0.07|-0.38|<0.001
72479922|NCT01191268|144485974|NON_INFERIORITY_OR_EQUIVALENCE|If the 1-sided adjusted p-value was below 0.025, then 0.75 mg LY2189265 was declared non-inferior to Insulin Glargine.|LS Mean Difference|-0.17|||<|0.001|TWO_SIDED|95.0|-0.33|-0.02||Family-wise Type I error rate was controlled by applying tree-gatekeeping strategy.|ANCOVA|||||-0.02|-0.33|<0.001
72479923|NCT01191268|144485974|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.22||||0.005|TWO_SIDED|95.0|-0.38|-0.07||Family-wise Type I error rate was controlled by applying tree-gatekeeping strategy.|ANCOVA|||Superiority analysis.||-0.07|-0.38|0.005
72479924|NCT01191268|144485974|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.17||||0.015|TWO_SIDED|95.0|-0.33|-0.02||Family-wise Type I error rate was controlled by applying tree-gatekeeping strategy.|ANCOVA|||Superiority analysis.||-0.02|-0.33|0.015
72479925|NCT01191268|144485975|NON_INFERIORITY_OR_EQUIVALENCE|If the upper limit of the 95% Confidence Interval (CI) of 1.5 mg LY2189265 versus Insulin Glargine was below 0.4%, 1.5 mg LY2189265 was declared non-inferior to Insulin Glargine.|LS Mean Difference|-0.25|||<|0.001|TWO_SIDED|95.0|-0.42|-0.07||Family-wise Type I error rate was controlled by applying tree-gatekeeping strategy.|ANCOVA|||||-0.07|-0.42|<0.001
72479926|NCT01191268|144485975|NON_INFERIORITY_OR_EQUIVALENCE|If the 1-sided adjusted p-value was below 0.025, then 0.75 mg LY2189265 was declared non-inferior to Insulin Glargine.|LS Mean Difference|-0.19|||<|0.001|TWO_SIDED|95.0|-0.37|-0.02||Family-wise Type I error rate was controlled by applying tree-gatekeeping strategy.|ANCOVA|||||-0.02|-0.37|<0.001
72479927|NCT01191268|144485975|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.25||||0.005|TWO_SIDED|95.0|-0.42|-0.07||Family-wise Type I error rate was controlled by applying tree-gatekeeping strategy.|ANCOVA|||Superiority analysis.||-0.07|-0.42|0.005
72479928|NCT01191268|144485975|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.19||||0.014|TWO_SIDED|95.0|-0.37|-0.02||Family-wise Type I error rate was controlled by applying tree-gatekeeping strategy.|ANCOVA|||Superiority analysis.||-0.02|-0.37|0.014
72479929|NCT01191268|144485976|SUPERIORITY_OR_OTHER|||||||0.014||||||Treatment comparison for HbA1c less than 7.0% at 26 weeks.|Regression, Logistic|||||||0.014
72479930|NCT01191268|144485976|SUPERIORITY_OR_OTHER|||||||0.01||||||Treatment comparison for HbA1c less than 7.0% at 26 weeks.|Regression, Logistic|||||||0.010
72479931|NCT01191268|144485976|SUPERIORITY_OR_OTHER|||||||0.027||||||Treatment comparison for HbA1c less than or equal to 6.5% at 26 weeks.|Regression, Logistic|||||||0.027
72479932|NCT01191268|144485976|SUPERIORITY_OR_OTHER|||||||0.384||||||Treatment comparison for HbA1c less than or equal to 6.5% at 26 weeks.|Regression, Logistic|||||||0.384
72479933|NCT01191268|144485976|SUPERIORITY_OR_OTHER||||||<|0.05||||||Treatment comparison for HbA1c less than 7% at 52 weeks.|Regression, Logistic|||||||<0.05
72479934|NCT01191268|144485976|SUPERIORITY_OR_OTHER|||||||0.25||||||Treatment comparison for HbA1c less than 7% at 52 weeks.|Regression, Logistic|||||||0.250
72479935|NCT01191268|144485976|SUPERIORITY_OR_OTHER|||||||0.272||||||Treatment comparison for HbA1c less than or equal to 6.5% at 52 weeks.|Regression, Logistic|||||||0.272
72479936|NCT01191268|144485976|SUPERIORITY_OR_OTHER|||||||0.623||||||Treatment comparison for HbA1c less than or equal to 6.5% at 52 weeks.|Regression, Logistic|||||||0.623
72479937|NCT01191268|144485977|SUPERIORITY_OR_OTHER||||||<|0.001||||||Treatment comparison at 26 weeks.|Regression, Logistic|||||||<0.001
72479938|NCT01191268|144485977|SUPERIORITY_OR_OTHER||||||<|0.001||||||Treatment comparison at 26 weeks.|Regression, Logistic|||||||<0.001
72479939|NCT01191268|144485977|SUPERIORITY_OR_OTHER||||||<|0.001||||||Treatment comparison at 52 weeks.|Regression, Logistic|||||||<0.001
72509835|NCT01856595|144550526|SUPERIORITY_OR_OTHER||Ratio|1.12|STANDARD_ERROR_OF_MEAN|1.154||0.4405|TWO_SIDED|90.0|0.88|1.42||Two-sided p-values are from ANCOVA model with treatment as a factor and baseline value as a covariate using the natural log-transformed AUC0-4. P-values are not adjusted for multiple comparisons.|ANCOVA|||Placebo was the Reference and each of the active doses was the Test.||1.42|0.88|0.4405
72509836|NCT01856595|144550526|SUPERIORITY_OR_OTHER||Ratio|1.09|STANDARD_ERROR_OF_MEAN|1.146||0.5178|TWO_SIDED|90.0|0.87|1.37||Two-sided p-values are from ANCOVA model with treatment as a factor and baseline value as a covariate using the natural log-transformed AUC0-4. P-values are not adjusted for multiple comparisons.|ANCOVA|||Placebo was the Reference and each of the active doses was the Test.||1.37|0.87|0.5178
72479940|NCT01191268|144485977|SUPERIORITY_OR_OTHER||||||<|0.001||||||Treatment comparison at 52 weeks.|Regression, Logistic|||||||<0.001
72479941|NCT01191268|144485978|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.07||||0.628|TWO_SIDED|95.0|-0.35|0.21||Treatment comparison of Daily Mean values at 26 weeks.|Mixed Models Analysis|||||0.21|-0.35|0.628
72479942|NCT01191268|144485978|SUPERIORITY_OR_OTHER||LS Mean Difference|0.13||||0.368|TWO_SIDED|95.0|-0.15|0.41||Treatment comparison of Daily Mean values at 26 weeks.|Mixed Models Analysis|||||0.41|-0.15|0.368
72479943|NCT01191268|144485978|SUPERIORITY_OR_OTHER||LS Mean Difference|0.13||||0.37|TWO_SIDED|95.0|-0.16|0.42||Treatment comparison of Daily Mean values at 52 weeks.|Mixed Models Analysis|||||0.42|-0.16|0.370
72479944|NCT01191268|144485978|SUPERIORITY_OR_OTHER||LS Mean Difference|0.02||||0.879|TWO_SIDED|95.0|-0.26|0.3||Treatment comparison of Daily Mean values at 52 weeks.|Mixed Models Analysis|||||0.30|-0.26|0.879
72479945|NCT01191268|144485979|SUPERIORITY_OR_OTHER||LS Mean Difference|1.31|||<|0.001|TWO_SIDED|95.0|0.83|1.79||Treatment comparison at 26 weeks.|Mixed Models Analysis|||||1.79|0.83|<0.001
72479946|NCT01191268|144485979|SUPERIORITY_OR_OTHER||LS Mean Difference|1.8|||<|0.001|TWO_SIDED|95.0|1.32|2.28||Treatment comparison at 26 weeks.|Mixed Models Analysis|||||2.28|1.32|<0.001
72479947|NCT01191268|144485979|SUPERIORITY_OR_OTHER||LS Mean Difference|1.09|||<|0.001|TWO_SIDED|95.0|0.55|1.64||Treatment comparison at 52 weeks.|Mixed Models Analysis|||||1.64|0.55|<0.001
72479948|NCT01191268|144485979|SUPERIORITY_OR_OTHER||LS Mean Difference|1.42|||<|0.001|TWO_SIDED|95.0|0.88|1.96||Treatment comparison at 52 weeks.|Mixed Models Analysis|||||1.96|0.88|<0.001
72400541|NCT00975481|144308991|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.6513||||0.001|TWO_SIDED|95.0|3.5552|13.7474|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emin, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||13.7474|3.5552|0.0010
72509837|NCT01856595|144550527|SUPERIORITY_OR_OTHER||Ratio|0.69|STANDARD_ERROR_OF_MEAN|1.181||0.034|TWO_SIDED|90.0|0.52|0.92||Two-sided p-values are from ANCOVA model with treatment as a factor and baseline value as a covariate using the natural log-transformed AUC0-4. P-values are not adjusted for multiple comparisons.|ANCOVA|||Placebo was the Reference and each of the active doses was the Test.||0.92|0.52|0.0340
72509838|NCT01856595|144550527|SUPERIORITY_OR_OTHER||Ratio|1.2|STANDARD_ERROR_OF_MEAN|1.173||0.2519|TWO_SIDED|90.0|0.92|1.58||Two-sided p-values are from ANCOVA model with treatment as a factor and baseline value as a covariate using the natural log-transformed AUC0-4. P-values are not adjusted for multiple comparisons.|ANCOVA|||Placebo was the Reference and each of the active doses was the Test.||1.58|0.92|0.2519
72400542|NCT00975481|144308992|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.6388|||<|0.0001|TWO_SIDED|95.0|10.5727|22.7049|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emax, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||22.7049|10.5727|<0.0001
72479949|NCT01191268|144485981|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.2|||<|0.001|TWO_SIDED|95.0|-3.81|-2.59||Treatment comparison at 26 weeks.|ANCOVA|||||-2.59|-3.81|<0.001
72566629|NCT00474851|144663582|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED|||||p (within group for participants receiving norethindrone + estrogens)=0.0001 p (within group for participants receiving norethindrone + placebo)=0.31 p (between groups)=0.02|RMANOVA|||"The time course of each measurement from baseline to 3, 6, 9, and 12 months was compared between arms by repeated-measures analysis of variance (RM-ANOVA), with an autoregressive covariance model to account for visit-to-visit correlation within subjects.~The primary test of treatment efficacy was time × treatment interaction. Adjusted changes over time and differences between trial arms were constructed from parameters of the RMANOVA."||||0.02
72479950|NCT01191268|144485981|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.15|||<|0.001|TWO_SIDED|95.0|-2.76|-1.54||Treatment comparison at 26 weeks.|ANCOVA|||||-1.54|-2.76|<0.001
72479951|NCT01191268|144485981|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.23|||<|0.001|TWO_SIDED|95.0|-3.99|-2.48||Treatment comparison at 52 weeks.|ANCOVA|||||-2.48|-3.99|<0.001
72479952|NCT01191268|144485981|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.03|||<|0.001|TWO_SIDED|95.0|-2.78|-1.27||Treatment comparison at 52 weeks.|ANCOVA|||||-1.27|-2.78|<0.001
72479953|NCT01191268|144485983|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.2|||<|0.001|TWO_SIDED|95.0|-1.44|-0.96||Treatment comparison at 26 weeks.|Mixed Models Analysis|||||-0.96|-1.44|<0.001
72509839|NCT01856595|144550528|SUPERIORITY_OR_OTHER||Ratio|1.06|STANDARD_ERROR_OF_MEAN|1.079||0.4579|TWO_SIDED|90.0|0.93|1.2||Two-sided p-values are from ANCOVA model with treatment as a factor and baseline value as a covariate using the natural log-transformed AUC0-4. P-values are not adjusted for multiple comparisons.|ANCOVA|||Placebo was the Reference and each of the active doses was the Test.||1.20|0.93|0.4579
72479954|NCT01191268|144485983|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.79|||<|0.001|TWO_SIDED|95.0|-1.03|-0.55||Treatment comparison at 26 weeks.|Mixed Models Analysis|||||-0.55|-1.03|<0.001
72479955|NCT01191268|144485983|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.24|||<|0.001|TWO_SIDED|95.0|-1.55|-0.94||Treatment comparison at 52 weeks.|Mixed Models Analysis|||||-0.94|-1.55|<0.001
72479956|NCT01191268|144485983|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.76|||<|0.001|TWO_SIDED|95.0|-1.06|-0.46||Treatment comparison at 52 weeks.|Mixed Models Analysis|||||-0.46|-1.06|<0.001
72479957|NCT02294227|144486005|SUPERIORITY||Odds Ratio (OR)|3.07||||0.0002|TWO_SIDED|95.0|1.66|5.66|||Chi-squared|||||5.66|1.66|0.0002
72479958|NCT02294227|144486005|SUPERIORITY||Odds Ratio (OR)|3.24||||0.0003|TWO_SIDED|95.0|1.76|5.97|||Chi-squared, Corrected|||||5.97|1.76|0.0003
72479959|NCT01209780|144486014|NON_INFERIORITY_OR_EQUIVALENCE|The investigational TIV was to be considered non-inferior to the control TIV if for all three strains the upper bound of the two-sided 95% CI on the difference between the seroconversion rates (Seroconversion control - Seroconversion investigational) at 21 days after last vaccination does not exceed 10 percentage points.|Vaccine group difference (%)|-1.0|||||TWO_SIDED|95.0|-4.0|2.0||||||Non-inferiority of investigational TIV to control TIV against A/H1N1 influenza strain||2|-4|
72479960|NCT01209780|144486014|NON_INFERIORITY_OR_EQUIVALENCE|The investigational TIV was to be considered non-inferior to the control TIV if, for all three strains, the upper bound of the two-sided 95% CI on the difference between the seroconversion rates (Seroconversion control - Seroconversion investigational), at 21 days after last vaccination, does not exceed 10 percentage points|Vaccine group difference (%)|10.0|||||TWO_SIDED|95.0|6.0|14.0||||||Non-inferiority of investigational TIV to control TIV against A/H3N2 influenza strain||14|6|
72479961|NCT01209780|144486014|NON_INFERIORITY_OR_EQUIVALENCE|The investigational TIV was to be considered non-inferior to the control TIV if, for all three strains, the upper bound of the two-sided 95% CI on the difference between the seroconversion rates (Seroconversion control - Seroconversion investigational), at 21 days after last vaccination, does not exceed 10 percentage points|Vaccine group difference (%)|-1.0|||||TWO_SIDED|95.0|-5.0|3.0||||||Non-inferiority of investigational TIV to the control TIV against B influenza strain||3|-5|
72509840|NCT01856595|144550528|SUPERIORITY_OR_OTHER||Ratio|0.98|STANDARD_ERROR_OF_MEAN|1.079||0.8144|TWO_SIDED|90.0|0.87|1.11||Two-sided p-values are from ANCOVA model with treatment as a factor and baseline value as a covariate using the natural log-transformed AUC0-4. P-values are not adjusted for multiple comparisons.|ANCOVA|||Placebo was the Reference and each of the active doses was the Test.||1.11|0.87|0.8144
72509841|NCT01856595|144550528|SUPERIORITY_OR_OTHER||Ratio|0.93|STANDARD_ERROR_OF_MEAN|1.082||0.3425|TWO_SIDED|90.0|0.81|1.06||Two-sided p-values are from ANCOVA model with treatment as a factor and baseline value as a covariate using the natural log-transformed AUC0-4. P-values are not adjusted for multiple comparisons.|ANCOVA|||Placebo was the Reference and each of the active doses was the Test.||1.06|0.81|0.3425
72400543|NCT00975481|144308992|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|19.8432|||<|0.0001|TWO_SIDED|95.0|13.7627|25.9238|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emax, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||25.9238|13.7627|<0.0001
72479962|NCT01209780|144486016|NON_INFERIORITY_OR_EQUIVALENCE|The investigational TIV was to be considered non-inferior to the control TIV, if for all three strains, the upper bound of the two-sided 95% CI on the ratio of the GMTs (GMTcontrol/GMTinvestigational) at 21 days after last vaccination does not exceed 1.5|Ratio of GMTs|1.32|||||TWO_SIDED|95.0|1.11|1.56||||||Non-inferiority of investigational TIV to licensed control TIV against A/H1N1 influenza strain||1.56|1.11|
72479963|NCT01209780|144486016|NON_INFERIORITY_OR_EQUIVALENCE|The investigational TIV was to be considered non-inferior to the control TIV, if for all three strains, the upper bound of the two-sided 95% CI on the ratio of the GMTs (GMTcontrol/GMTinvestigational) at 21 days after last vaccination does not exceed 1.5|Ratio of GMTs|1.48|||||TWO_SIDED|95.0|1.34|1.64||||||Non-inferiority of investigational TIV to licensed control TIV against A/H3N2 influenza strain||1.64|1.34|
72479964|NCT01209780|144486016|NON_INFERIORITY_OR_EQUIVALENCE|The investigational TIV was to be considered non-inferior to the control TIV, if for all three strains, the upper bound of the two-sided 95% CI on the ratio of the GMTs (GMTcontrol/GMTinvestigational) at 21 days after last vaccination does not exceed 1.5|Ratio of GMTs|0.95|||||TWO_SIDED|95.0|0.85|1.07||||||Non-inferiority of investigational TIV to licensed control TIV against B influenza strain||1.07|0.85|
72479965|NCT00511472|144486026|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|46.1|STANDARD_ERROR_OF_MEAN|14.15||0.001|TWO_SIDED|90.0|22.71|69.5|||ANOVA|||For the least square mean difference - baseline in the ANOVA model = glucose value at Titration Day 1 pre-Breakfast for Titration Group 1||69.50|22.71|0.001
72479966|NCT00511472|144486026|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|50.28|STANDARD_ERROR_OF_MEAN|13.67|<|0.001|TWO_SIDED|90.0|27.68|72.88|||ANOVA|||For the least square mean difference - baseline in the ANOVA model = glucose value at Titration Day 1 pre-breakfast for Titration Group 2||72.88|27.68|<0.001
72479967|NCT01588496|144486048|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-29.78|STANDARD_ERROR_OF_MEAN|5.54|<|0.001|TWO_SIDED|95.0|-40.94|-18.62||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Model includes treatment group, baseline LDL-C level (\< 420 vs ≥ 420 mg/dL), scheduled visit and the interaction of treatment with scheduled visit.|Placebo is the reference|||-18.62|-40.94|<0.001
72479968|NCT01588496|144486049|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-23.14|STANDARD_ERROR_OF_MEAN|5.81|<|0.001|TWO_SIDED|95.0|-34.83|-11.45||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Model includes treatment group, baseline LDL-C level (\< 420 vs ≥ 420 mg/dL), scheduled visit and the interaction of treatment with scheduled visit.|Placebo is the reference|||-11.45|-34.83|<0.001
72479969|NCT01588496|144486050|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-22.89|STANDARD_ERROR_OF_MEAN|5.38|<|0.001|TWO_SIDED|95.0|-33.72|-12.05||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Model includes treatment group, baseline LDL-C level (\< 420 vs ≥ 420 mg/dL), scheduled visit and the interaction of treatment with scheduled visit.|Placebo is the reference|||-12.05|-33.72|<0.001
72509842|NCT01856595|144550528|SUPERIORITY_OR_OTHER||Ratio|1.0|STANDARD_ERROR_OF_MEAN|1.076||0.967|TWO_SIDED|90.0|0.88|1.13||Two-sided p-values are from ANCOVA model with treatment as a factor and baseline value as a covariate using the natural log-transformed AUC0-4. P-values are not adjusted for multiple comparisons.|ANCOVA|||Placebo was the Reference and each of the active doses was the Test.||1.13|0.88|0.9670
72509843|NCT01856595|144550528|SUPERIORITY_OR_OTHER||Ratio|1.08|STANDARD_ERROR_OF_MEAN|1.079||0.319|TWO_SIDED|90.0|0.95|1.23||Two-sided p-values are from ANCOVA model with treatment as a factor and baseline value as a covariate using the natural log-transformed AUC0-4. P-values are not adjusted for multiple comparisons.|ANCOVA|||Placebo was the Reference and each of the active doses was the Test.||1.23|0.95|0.3190
72566630|NCT02791893|144663591|SUPERIORITY|||||||0.47||||||The a priori threshold for statistical significance was p = 0.05.|ANCOVA|||A power analysis was conducted with G\*Power, specifying a standard Type I error (α = .05) and desired power of .80. Results indicated that a total sample of 26 would be sufficient. Below are the results of the intent-to-treat analysis. Patients that did not complete the assessment after the blinded phase had their baseline scores carried forward. Post-intervention pain severity was regressed on pre-intervention pain severity and condition, using an ANCOVA model.||||0.47
72509844|NCT01856595|144550529|SUPERIORITY_OR_OTHER||Ratio|1.14|STANDARD_ERROR_OF_MEAN|1.095||0.1617|TWO_SIDED|90.0|0.98|1.32||Two-sided p-values are from ANCOVA model with treatment as a factor and baseline value as a covariate using the natural log-transformed AUC0-4. P-values are not adjusted for multiple comparisons.|ANCOVA|||Placebo was the Reference and each of the active doses was the Test.||1.32|0.98|0.1617
72509845|NCT01856595|144550529|SUPERIORITY_OR_OTHER||Ratio|1.08|STANDARD_ERROR_OF_MEAN|1.084||0.3703|TWO_SIDED|90.0|0.94|1.23||Two-sided p-values are from ANCOVA model with treatment as a factor and baseline value as a covariate using the natural log-transformed AUC0-4. P-values are not adjusted for multiple comparisons.|ANCOVA|||Placebo was the Reference and each of the active doses was the Test.||1.23|0.94|0.3703
72509846|NCT01856595|144550530|SUPERIORITY_OR_OTHER||Ratio|0.95|STANDARD_ERROR_OF_MEAN|1.119||0.6833|TWO_SIDED|90.0|0.79|1.15||Two-sided p-values are from ANCOVA model with treatment as a factor and baseline value as a covariate using the natural log-transformed AUC0-4. P-values are not adjusted for multiple comparisons.|ANCOVA|||Placebo was the Reference and each of the active doses was the Test.||1.15|0.79|0.6833
72509847|NCT01856595|144550530|SUPERIORITY_OR_OTHER||Ratio|1.18|STANDARD_ERROR_OF_MEAN|1.112||0.1318|TWO_SIDED|90.0|0.98|1.41||Two-sided p-values are from ANCOVA model with treatment as a factor and baseline value as a covariate using the natural log-transformed AUC0-4. P-values are not adjusted for multiple comparisons.|ANCOVA|||Placebo was the Reference and each of the active doses was the Test.||1.41|0.98|0.1318
72623683|NCT00023595|144778192|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.05||||0.717|TWO_SIDED|95.0|0.83|1.32|||Log Rank||Hazard Ratio is for (H02: Medication + CABG + SVR) versus (H02: Medication + CABG)|||1.32|0.83|0.717
72509848|NCT01071044|144550590|SUPERIORITY_OR_OTHER_LEGACY|||||||0.005||95.0|||||ANOVA|These data were initially analyzed with a one-way ANOVA.||These scores were calculated by subtracting participants' endpoint scores from their initial baseline scores. These change scores show the total change in executive functioning over the course of the trial. Higher values indicate improved executive functioning at the end of the trial compared to the beginning.||||.005
72509849|NCT01071044|144550591|SUPERIORITY_OR_OTHER_LEGACY|||||||0.008|TWO_SIDED|95.0|||||ANOVA|||These scores were calculated by subtracting participants' endpoint scores from their initial baseline scores. These change scores show the total change in executive functioning over the course of the trial. Higher values indicate improved executive functioning at the end of the trial compared to the beginning.||||0.008
72509850|NCT01071044|144550592|SUPERIORITY_OR_OTHER_LEGACY|||||||0.183||95.0|||||ANOVA|||These scores were calculated by subtracting participants' endpoint scores from their initial baseline scores. These change scores show the total change in executive functioning over the course of the trial. Higher values indicate improved executive functioning at the end of the trial compared to the beginning.||||0.183
72479970|NCT01588496|144486051|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-11.83|STANDARD_ERROR_OF_MEAN|6.77||0.088|TWO_SIDED|95.0|-25.48|1.82||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Model includes treatment group, baseline LDL-C level (\< 420 vs ≥ 420 mg/dL), scheduled visit and the interaction of treatment with scheduled visit.|Placebo is the reference|||1.82|-25.48|0.088
72509851|NCT01071044|144550593|SUPERIORITY_OR_OTHER_LEGACY|||||||0.046||95.0|||||ANOVA|||These scores were calculated by subtracting participants' endpoint scores from their initial baseline scores. These change scores show the total change in executive functioning over the course of the trial. Higher values indicate improved executive functioning at the end of the trial compared to the beginning.||||0.046
72509852|NCT01071044|144550594|SUPERIORITY_OR_OTHER_LEGACY|||||||0.219||95.0|||||ANOVA|||These scores were calculated by subtracting participants' endpoint scores from their initial baseline scores. These change scores show the total change in executive functioning over the course of the trial. Higher values indicate improved executive functioning at the end of the trial compared to the beginning.||||0.219
72479971|NCT01588496|144486052|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-11.27|STANDARD_ERROR_OF_MEAN|5.86||0.088|TWO_SIDED|95.0|-23.11|0.56||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects|Model includes treatment group, baseline LDL-C level (\< 420 vs ≥ 420 mg/dL), scheduled visit and the interaction of treatment with scheduled visit.|Placebo is the reference|||0.56|-23.11|0.088
72479972|NCT01588496|144486053|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-30.93|STANDARD_ERROR_OF_MEAN|6.42|<|0.001|TWO_SIDED|95.0|-43.86|-18.0||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Model includes treatment group, baseline LDL-C level (\< 420 vs ≥ 420 mg/dL), scheduled visit and the interaction of treatment with scheduled visit.|Placebo is the reference|LDL-C lowering was analyzed by comparing evolocumab and placebo. Statistical analysis was 2-sided with a significance level of 0.05.||-18.00|-43.86|<0.001
72479973|NCT01551212|144486054|SUPERIORITY||Mean Difference (Final Values)|4.09||||0.097|TWO_SIDED|95.0|-0.74|8.91|||ANCOVA|factors: treatment, center, HCV-Class (positive, negative) and lab MELD (≤ 30 vs \> 30) covariate: baseline value||||8.91|-0.74|0.097
72509853|NCT01071044|144550595|SUPERIORITY_OR_OTHER_LEGACY|||||||0.038||95.0|||||ANOVA|||These scores were calculated by subtracting participants' endpoint scores from their initial baseline scores. These change scores show the total change in executive functioning over the course of the trial. Higher values indicate improved executive functioning at the end of the trial compared to the beginning.||||0.038
72509854|NCT01071044|144550596|SUPERIORITY_OR_OTHER_LEGACY|||||||0.022||95.0|||||ANOVA|||These scores were calculated by subtracting participants' endpoint scores from their initial baseline scores. These change scores show the total change in executive functioning over the course of the trial. Higher values indicate improved executive functioning at the end of the trial compared to the beginning.||||0.022
72509855|NCT00069576|144550598|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.87||||0.14|TWO_SIDED|97.0|0.72|1.07|||Chi-squared|||For Total Composite End Point||1.07|0.72|0.14
72509856|NCT00069576|144550598|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.06||||0.75|TWO_SIDED|97.0|0.73|1.53|||Chi-squared|||Analysis for Hypoglycemia||1.53|0.73|0.75
72509857|NCT00069576|144550598|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.74||||0.12|TWO_SIDED|97.0|0.49|1.12|||Chi-squared|||Analysis for hyperbilirubinemia||1.12|0.49|0.12
72509858|NCT00069576|144550598|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.78||||0.07|TWO_SIDED|97.0|0.57|1.05|||Chi-squared|||Analysis for elevated cord-blood C-peptide level||1.05|0.57|0.07
72509859|NCT00069576|144550598|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.48||||0.33|TWO_SIDED|97.0|0.1|2.2|||Chi-squared|||Analysis for birth trauma||2.20|0.10|0.33
72509860|NCT00069576|144550599|SUPERIORITY||Risk Ratio (RR)|0.94|||||TWO_SIDED|95.0|0.68|1.28||||||||1.28|0.68|
72509861|NCT00069576|144550600|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.49|||<|0.001|TWO_SIDED|97.0|0.32|0.76|||Chi-squared|||||0.76|0.32|<0.001
72509862|NCT00069576|144550601|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.41|||<|0.001|TWO_SIDED|97.0|0.26|0.66|||Chi-squared|||||0.66|0.26|<0.001
72509863|NCT00069576|144550602|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.81||||0.27|TWO_SIDED|97.0|0.53|1.23|||Chi-squared|||||1.23|0.53|0.27
72509864|NCT00069576|144550603|SUPERIORITY_OR_OTHER|||||||0.003|||||||Wilcoxon (Mann-Whitney)|||||||0.003
72509865|NCT00069576|144550604|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.18||||0.49|TWO_SIDED|97.0|0.7|1.99|||Chi-squared|||||1.99|0.70|0.49
72509866|NCT00069576|144550605|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
72509867|NCT00069576|144550606|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.77||||0.19|TWO_SIDED|97.0|0.51|1.18|||Chi-squared|||||1.18|0.51|0.19
72509868|NCT00069576|144550607|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.77||||0.32|TWO_SIDED|97.0|0.44|1.36|||Chi-squared|||||1.36|0.44|0.32
72509869|NCT00069576|144550608|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.66||||0.33|TWO_SIDED|97.0|0.26|1.67|||Chi-squared|||||1.67|0.26|0.33
72509870|NCT00069576|144550609|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.02||||0.86|TWO_SIDED|97.0|0.81|1.29|||Chi-squared|||||1.29|0.81|0.86
72509871|NCT00069576|144550610|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.79||||0.02|TWO_SIDED|97.0|0.64|0.99|||Chi-squared|||||0.99|0.64|0.02
72509872|NCT00069576|144550611|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.37||||0.02|TWO_SIDED|97.0|0.14|0.97|||Chi-squared|||||0.97|0.14|0.02
72400544|NCT00975481|144308992|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.6121||||0.6029|TWO_SIDED|95.0|-7.7209|4.4967|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emax, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||4.4967|-7.7209|0.6029
72400545|NCT00975481|144308992|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.9241||||0.3477|TWO_SIDED|95.0|-9.0571|3.2089|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emax, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||3.2089|-9.0571|0.3477
72479974|NCT01551212|144486055|SUPERIORITY||Mean Difference (Final Values)|7.99||||0.0085|TWO_SIDED|95.0|2.06|13.92|||ANCOVA|factors: treatment, center, HCV-Class (positive, negative) and lab MELD (≤ 30 vs \> 30) covariate: baseline value||||13.92|2.06|0.0085
72479975|NCT01551212|144486056|SUPERIORITY|||||||0.699|||||||Fisher Exact|||||||0.699
72566631|NCT02791893|144663591|SUPERIORITY|||||||0.58||||||The a priori threshold for statistical significance was p = 0.05.|ANCOVA|||Below are the results of the per protocol analysis. Patients that did not complete the assessment after the blinded phase are not included limiting the sample to 10 subjects in each condition (N=20). Post-intervention pain severity was regressed on pre-intervention pain severity and condition, using an ANCOVA model.||||0.58
72400546|NCT00975481|144308992|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0908||||0.9769|TWO_SIDED|95.0|-6.085|6.2667|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emax, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||6.2667|-6.0850|0.9769
72479976|NCT00705523|144486061|SUPERIORITY_OR_OTHER|||||||0.1|||||||Regression, Logistic|beta=-0.67, exp(beta)=0.51, chi-squared(1) = 0.2.71||Self-reported drinking results, as gathered by the TLFB, were compared by the generalized estimating equations (GEE) (Diggle et al., 1994), using Poisson models for counts of drinking and heavy drinking days, and logistic regression models for absence/presence binary indicators of drinking. In the GEE model, the pre-treatment of the response was included as a covariate, together with the treatment group indicator, and a linear time effect.||||0.10
72479977|NCT00953745|144486068|SUPERIORITY_OR_OTHER|||||||0.029||||||paired t-test thresholded at cluster level significance of p=0.001; family-wise error multiple comparisons corrected|t-test, 1 sided|||A region of increased relative Fluorodopa (FDOPA) uptake in the right medial caudate was anticipated for the aripiprazole augmentation responders over the 6 weeks of augmentation treatment (Weeks 10-16).||||0.029
72479978|NCT00953745|144486069|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
72479979|NCT00953745|144486069|SUPERIORITY_OR_OTHER|||||||0.366|||||||t-test, 2 sided|||||||0.366
72479980|NCT03110185|144486073|OTHER|Correlation||||||0.0761||||||Delirium Incidence. There were no multiple comparisons, but includes age as a regressor. a priori threshold was p \< 0.05.|Regression, Logistic|Generalized logistic regression for delirium incidence and total DMN fc with age as a regressor.||||||0.0761
72479981|NCT02112838|144486074|SUPERIORITY||Mean Difference (Final Values)|19.9||||0.97|TWO_SIDED|95.0|-910.6|950.5|||ANCOVA|||||950.5|-910.6|0.97
72479982|NCT02112838|144486074|SUPERIORITY||Mean Difference (Final Values)|-399.7||||0.4|TWO_SIDED|95.0|-1320.8|521.3|||ANCOVA|||||521.3|-1320.8|0.40
72479983|NCT03430206|144486090|OTHER|||||||0.206|||||||Regression, Negative Binomial|||||||0.206
72479984|NCT03430206|144486091|OTHER|||||||0.101|||||||Regression, Negative Binomial|||||||0.101
72479985|NCT03430206|144486092|OTHER|||||||0.371|||||||Regression, Negative Binomial|||||||0.371
72479986|NCT03430206|144486094|OTHER|||||||0.601|||||||Regression, Negative Binomial|||||||0.601
72479987|NCT03430206|144486095|OTHER|||||||0.738|||||||Regression, Negative Binomial|||||||0.738
72479988|NCT03534284|144486109|SUPERIORITY|||||||0.6761||||||0.05 threshold for significance; no adjustment for multiple comparisons|Mixed Models Analysis|||Null hypothesis: average CBT-I=Trazodone=Placebo at week 7||||0.6761
72623684|NCT00023595|144778193|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.84||||0.018|TWO_SIDED|95.0|0.73|0.97|||Log Rank||Hazard Ratio is for (H01: Medication +CABG) versus (H01: Medication)|||0.97|0.73|0.018
72623685|NCT00023595|144778209|SUPERIORITY|||||||0.015||||||4 months|Chi-squared|H01 P-values were based on the Chi-Square test applied to maximum likelihood estimates derived from an adjusted mixed model.||||||0.015
72479989|NCT03534284|144486110|SUPERIORITY|||||||0.8375|||||||Mixed Models Analysis|||Null hypothesis: average CBT-I=Trazodone=Placebo at week 25||||0.8375
72479990|NCT04737187|144486133|SUPERIORITY||Hazard Ratio (HR)|0.61|||<|0.001|TWO_SIDED|95.0|0.49|0.77||Stratified log-rank test, with a target p-value \< 0.025 for level of significance.|Stratified log-rank test||Hazard ratio and 95% confidence interval was estimated with stratified Cox proportional hazard model.|Overall Survival Median analysis: The primary estimand was defined to assess the effect of the randomized treatments on the survival duration in all participants regardless of whether or not intercurrent events had occurred (treatment policy strategy).||0.77|0.49|< 0.001
72479991|NCT04737187|144486137|SUPERIORITY||Hazard Ratio (HR)|0.44|||<|0.001|TWO_SIDED|95.0|0.36|0.54||Stratified log-rank test, with a target p-value \< 0.025 for level of significance.|Stratified log-rank test||Hazard ratio and 95% confidence interval was estimated with stratified Cox proportional hazard model.|PFS Median analysis: A hierarchical testing method was used to control type I error and handle key secondary endpoint analysis. When the primary outcome measure significant testing was then performed sequentially on the key secondary outcome measure. statistically significant at 0.05 level.||0.54|0.36|< 0.001
72479992|NCT01605292|144486165|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||t-test, 2 sided|||||||<0.0001
72479993|NCT01605292|144486166|SUPERIORITY_OR_OTHER|||||||0.006|TWO_SIDED||||||t-test, 2 sided|||||||0.006
72479994|NCT01605292|144486167|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Fisher Exact|||||||<0.0001
72479995|NCT01605292|144486168|SUPERIORITY_OR_OTHER|||||||0.56|TWO_SIDED||||||Fisher Exact|||||||0.56
72479996|NCT01605292|144486169|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Fisher Exact|||||||<0.0001
72400547|NCT00975481|144308992|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-18.2509|||<|0.0001|TWO_SIDED|95.0|-24.3155|-12.1864|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emax, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-12.1864|-24.3155|<0.0001
72566632|NCT02791893|144663592|SUPERIORITY|||||||0.23||||||The a priori threshold for statistical significance was p = 0.05.|t-test, 2 sided|This was an independent t-test comparing the conditions on their perception of change since starting the intervention.||"A power analysis was conducted with G\*Power, specifying a standard Type I error (α = .05) and desired power of .80. Results indicated that a total sample of 26 would be sufficient. Below are the results of the intent-to-treat analysis. Patients that did not complete the assessment after the blinded phase were assigned a score of 1 indicating no change in their condition. Post-intervention PGIC scores were compared between conditions."||||0.23
72566633|NCT02791893|144663592|SUPERIORITY||Mean Difference (Final Values)|1.1||||0.23|TWO_SIDED|||||The a priori threshold for statistical significance was p = 0.05.|t-test, 2 sided|This was an independent t-test comparing the conditions on their perception of change since starting the intervention.|Condition difference = Active - Sham|Below are the results of the per protocol analysis. Post-intervention PGIC scores were compared between conditions.||||0.23
72566634|NCT02791893|144663593|SUPERIORITY||Mean Difference (Final Values)|12.88||||0.13|TWO_SIDED|||||The a priori threshold for statistical significance was p = 0.05.|ANCOVA||Condition difference = Active - Sham|A power analysis was conducted with G\*Power, specifying a standard Type I error (α = .05) and desired power of .80. Results indicated that a total sample of 26 would be sufficient. Below are the results of the intent-to-treat analysis. Patients that did not complete the assessment after the blinded phase had their baseline scores carried forward. Post-intervention physical function scores was regressed on pre-intervention physical function and condition, using an ANCOVA model.||||0.13
72566635|NCT02791893|144663593|SUPERIORITY||Mean Difference (Final Values)|10.5||||0.12|TWO_SIDED|||||The a priori threshold for statistical significance was p = 0.05.|ANCOVA|||Below are the results of the per protocol analysis. Patients that did not complete the assessment after the blinded phase had their baseline scores carried forward. Post-intervention physical function scores was regressed on pre-intervention physical function and condition, using an ANCOVA model.||||0.12
72566636|NCT02791893|144663594|SUPERIORITY||Mean Difference (Final Values)|-5.71||||0.58|TWO_SIDED|||||The a priori threshold for statistical significance was p = 0.05.|ANCOVA||Condition difference = Active - Sham|A power analysis was conducted with G\*Power, specifying a standard Type I error (α = .05) and desired power of .80. Results indicated that a total sample of 26 would be sufficient. Below are the results of the intent-to-treat analysis. Patients that did not complete the assessment after the blinded phase had their baseline scores carried forward. Post-intervention headache days was regressed on pre-intervention headache days and condition, using an ANCOVA model.||||0.58
72566637|NCT02791893|144663594|SUPERIORITY||Mean Difference (Final Values)|-9.8||||0.49|TWO_SIDED|||||The a priori threshold for statistical significance was p = 0.05.|ANCOVA||Condition difference = Active - Sham|Below are the results of the per protocol analysis. Patients that did not complete the assessment after the blinded phase had their baseline scores carried forward. Post-intervention headache days was regressed on pre-intervention headache days and condition, using an ANCOVA model.||||0.49
72566638|NCT02791893|144663595|SUPERIORITY||Mean Difference (Final Values)|-1.42||||0.18|TWO_SIDED|||||The a priori threshold for statistical significance was p = 0.05.|ANCOVA||Condition difference = Active - Sham|A power analysis was conducted with G\*Power, specifying a standard Type I error (α = .05) and desired power of .80. Results indicated that a total sample of 26 would be sufficient. Below are the results of the intent-to-treat analysis. Patients that did not complete the assessment after the blinded phase had their baseline scores carried forward. Post-intervention depression scores were regressed on pre-intervention depression scores and condition, using an ANCOVA model.||||0.18
72566639|NCT02791893|144663595|SUPERIORITY||Mean Difference (Final Values)|-1.1||||0.25|TWO_SIDED|||||The a priori threshold for statistical significance was p = 0.05.|ANCOVA||Condition difference = Active - Sham|Below are the results of the per protocol analysis. Patients that did not complete the assessment after the blinded phase had their baseline scores carried forward. Post-intervention depression scores were regressed on pre-intervention depression scores and condition, using an ANCOVA model.||||0.25
72566640|NCT02791893|144663596|SUPERIORITY|||||||0.004||||||The a priori threshold for statistical significance was p = 0.05.|t-test, 2 sided|This was a dependent t-test comparing pre-intervention scores to the scores collected at the end of the open label phase.||Regardless of original condition assignment, patients' 2.5-month pain scores at the end of the open label phase were compared to their baseline scores using a dependent samples t-test. Below are the results of the intent-to-treat analysis. Patients that did not complete the assessment after the open-label phase had their most recent score carried forward. All patients included in this comparison received at least 10 weeks of VNS therapy.||||0.004
72566641|NCT02791893|144663596|SUPERIORITY|||||||0.005||||||This was a dependent t-test comparing baseline scores to the scores collected at the end of the open label phase.|t-test, 2 sided|||Regardless of original condition assignment, patients' 2.5-month pain scores at the end of the open label phase were compared to their baseline scores using a dependent samples t-test. Below are the results of the per protocol analysis. Patients that did not complete the assessment after the open-label phase were excluded. All patients included in this comparison received at least 10 weeks of VNS therapy.||||0.005
72566642|NCT03438396|144663597|OTHER|The statistical hypotheses was tested to address ORR \<= 11% vs. ORR \> 11%.||||||0.0002|||||||one-sided exact test|||||||0.0002
72623686|NCT00023595|144778209|SUPERIORITY|||||||0.002||||||12 months|Chi-squared|||||||0.002
72623687|NCT00023595|144778209|SUPERIORITY|||||||0.011||||||24 months|Chi-squared|||||||0.011
72623688|NCT00023595|144778209|SUPERIORITY|||||||0.44||||||36 months|Chi-squared|||||||0.44
72623689|NCT00023595|144778210|SUPERIORITY|||||||0.91||||||Baseline|Wilcoxon (Mann-Whitney)|||||||0.91
72623690|NCT00023595|144778210|SUPERIORITY|||||||0.62||||||4 months|Wilcoxon (Mann-Whitney)|||||||0.62
72623691|NCT00023595|144778210|SUPERIORITY|||||||0.04||||||12 months|Wilcoxon (Mann-Whitney)|||||||0.04
72623692|NCT00023595|144778210|SUPERIORITY|||||||0.96|||||||Wilcoxon (Mann-Whitney)|||||||0.96
72623693|NCT00023595|144778210|SUPERIORITY|||||||0.78|||||||Wilcoxon (Mann-Whitney)|||||||0.78
72509873|NCT00069576|144550612|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.46||||0.02|TWO_SIDED|97.0|0.22|0.97|||Chi-squared|||||0.97|0.22|0.02
72509874|NCT00069576|144550613|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.63||||0.01|TWO_SIDED|97.0|0.42|0.96|||Chi-squared|||||0.96|0.42|0.01
72509875|NCT00069576|144550614|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
72509876|NCT00069576|144550615|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
72509877|NCT00069576|144550616|SUPERIORITY||Risk Ratio (RR)|0.88|||||TWO_SIDED|95.0|0.71|1.1||||||||1.10|0.71|
72509878|NCT00069576|144550617|SUPERIORITY||Risk Ratio (RR)|1.05|||||TWO_SIDED|95.0|0.65|1.69||||||||1.69|0.65|
72509879|NCT00069576|144550618|SUPERIORITY||Risk Ratio (RR)|1.23|||||TWO_SIDED|95.0|0.74|2.05||||||||2.05|0.74|
72509880|NCT00069576|144550619|SUPERIORITY||Risk Ratio (RR)|0.76|||||TWO_SIDED|95.0|0.36|1.62||||||||1.62|0.36|
72509881|NCT00069576|144550620|SUPERIORITY_OR_OTHER|||||||0.87|||||||Wilcoxon (Mann-Whitney)|||||||0.87
72509882|NCT00830037|144550632|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.35||||0.79|TWO_SIDED|95.0|-2.9|2.3||a = 0.05|Mixed Models Analysis|Wald test||The analysis of the primary outcome was intention to treat, if the patient received at least one dose of the randomized drug (which was the case for each subject). A linear mixed model was used with GFR as the outcome variable. Fixed effects were indicator variables for time (treated as a continuous variable), treatment, and their interaction. Random effects were subject and time with unstructured covariance; statistical inference was made using the maximum likelihood estimator.||2.3|-2.9|0.79
72509883|NCT00830037|144550633|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.035||||0.83|TWO_SIDED|95.0|-0.294|0.365||a = 0.05|Mixed Models Analysis|Wald test||The secondary analysis examined the mean change from baseline proteinuria (log protein to creatinine ratio) at 2 years. The between-groups difference in mean change from baseline is reported with a 95% confidence interval and the p-value from the Wald test.||0.365|-0.294|0.83
72509884|NCT00752609|144550634|SUPERIORITY_OR_OTHER||Mean change from baseline|-0.42|||||TWO_SIDED|95.0|-0.65|-0.19|||||A two-sided 95% CI of the estimated mean change from Baseline in hemoglobin was derived from the t-distribution.|||-0.19|-0.65|
72509885|NCT00752609|144550634|SUPERIORITY_OR_OTHER||Mean change from baseline|0.49|||||TWO_SIDED|95.0|0.26|0.71|||||A two-sided 95% CI of the estimated mean change from Baseline in hemoglobin was derived from the t-distribution.|||0.71|0.26|
72509886|NCT02439281|144550655|OTHER|||||||0.451|||||||Wilcoxon (Mann-Whitney)|||||||0.4510
72509887|NCT02439281|144550656|OTHER|||||||0.8914|||||||Wilcoxon (Mann-Whitney)|||||||0.8914
72509888|NCT02439281|144550659|OTHER|||||||0.9531|||||||Wilcoxon (Mann-Whitney)|||||||0.9531
72509889|NCT02439281|144550660|OTHER|||||||0.778|||||||Wilcoxon (Mann-Whitney)|||||||0.7780
72509890|NCT02439281|144550661|OTHER|||||||0.5692|||||||Wilcoxon (Mann-Whitney)|||||||0.5692
72509891|NCT00358917|144550662|NON_INFERIORITY_OR_EQUIVALENCE|The 95% confidence interval for the difference in response rates (once daily \[QD\] minus twice daily \[BID\], based on the normal approximation to the binomial distribution) was used to assess noninferiority. The QD regimen was considered noninferior to the BID regimen if the lower limit of the confidence interval remained above -12%.|Diff. in Percentage of Subj. Responding|3.5||||0.413||95.0|-4.5|11.5|||normal approx. to binomial distribution|||The null hypothesis was that the response rate for the once daily (QD) regimen was more than 12% lower than the response rate for the twice daily (BID) regimen. The planned sample size of 600 participants (300 participants in each of the QD and BID treatment regimens) provided 83% power (with a type I error rate of 0.05) to reject the null hypothesis, i.e., to determine noninferiority based on the 12% margin.||11.5|-4.5|0.413
72509892|NCT00358917|144550663|SUPERIORITY_OR_OTHER||Diff. in Percentage of Subj. Responding|3.8||||0.389||95.0|-4.3|11.9|||normal approx. to binomial distribution|||||11.9|-4.3|0.389
72509893|NCT00358917|144550664|SUPERIORITY_OR_OTHER|||||||0.281||95.0|||||ANOVA|||||||0.281
72509894|NCT00358917|144550666|SUPERIORITY_OR_OTHER|||||||0.222||95.0|||||Fisher Exact|||||||0.222
72509895|NCT01254396|144550693|SUPERIORITY_OR_OTHER_LEGACY||Ratio of Adjusted Means|41.35|||||TWO_SIDED|90.0|32.4|52.76||||||Natural log transformed Cmax of sildenafil was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% confidence intervals for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% confidence intervals for the ratios.||52.76|32.40|
72509896|NCT01254396|144550695|SUPERIORITY_OR_OTHER_LEGACY||Ratio of Adjusted Means|93.42|||||TWO_SIDED|90.0|80.23|108.78||||||Natural log transformed AUC (0-∞) of sildenafil was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% confidence intervals for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% confidence intervals for the ratios.||108.78|80.23|
72509897|NCT01254396|144550696|SUPERIORITY_OR_OTHER_LEGACY||Ratio of Adjusted Means|87.66|||||TWO_SIDED|90.0|77.62|98.99||||||Natural log transformed AUClast of sildenafil was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% confidence intervals for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% confidence intervals for the ratios.||98.99|77.62|
72509898|NCT05372575|144550705|SUPERIORITY|The 2-sided 95% confidential interval (CI) on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|Geometric Mean Ratio (GMR)|13.16|||||TWO_SIDED|95.0|8.99|19.28|||||GMR=(GMC of 13vPnC Cohort)/(GMC of Non-13vPnC Cohort)|Geometric mean ratio (GMR) of 13vPnC Cohort/Non-13vPnC Cohort for Serotype: 1||19.28|8.99|
72509899|NCT05372575|144550705|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|5.88|||||TWO_SIDED|95.0|4.32|8.01|||||GMR=(GMC of 13vPnC Cohort)/(GMC of Non-13vPnC Cohort)|GMR of 13vPnC Cohort/Non-13vPnC Cohort for Serotype: 3||8.01|4.32|
72623694|NCT00023595|144778211|SUPERIORITY|||||||0.31||||||4 months|Chi-squared|H01 P-values were based on the Chi-Square test applied to maximum likelihood estimates derived from an adjusted mixed model.||||||0.31
72623695|NCT00023595|144778211|SUPERIORITY|||||||0.002||||||12 months|Chi-squared|||||||0.002
72400548|NCT00975481|144308992|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.5629|||<|0.0001|TWO_SIDED|95.0|-25.6616|-13.4642|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emax, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-13.4642|-25.6616|<0.0001
72400549|NCT00975481|144308992|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.548|||<|0.0001|TWO_SIDED|95.0|-22.7036|-10.3923|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emax, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-10.3923|-22.7036|<0.0001
72400550|NCT00975481|144308992|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-21.4554|||<|0.0001|TWO_SIDED|95.0|-27.4199|-15.4908|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emax, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-15.4908|-27.4199|<0.0001
72479997|NCT01605292|144486170|SUPERIORITY_OR_OTHER|||||||0.07|TWO_SIDED||||||Chi-squared|||||||0.07
72479998|NCT01605292|144486171|SUPERIORITY_OR_OTHER|||||||0.75|TWO_SIDED||||||Fisher Exact|||||||0.75
72479999|NCT01605292|144486173|SUPERIORITY_OR_OTHER|||||||0.007|TWO_SIDED||||||Fisher Exact|||||||0.007
72480000|NCT02401867|144486175|NON_INFERIORITY_OR_EQUIVALENCE|We selected our initial sample size of 150 participants to detect a clinically meaningful % discordance between the two sampling approaches and achieve 90% power at the 0.05 alpha-level using McNemar's test adjusted for analysis of clustered matched-pair data.||||||0.29||||||Statistical significance was determined at an a priori threshold of p \<0.05|McNemar|Degrees of freedom = 1||Comparing the concordance of the HPV DNA-positive results to the cervical provider swab HPV DNA test results (reference) using the McNemar's test, a two-sample test for binomial proportions for matched-pair data. Null hypothesis: The sensitivities between swab 1 (self-vaginal) and swab 2 (provider-cervical) are equal \[ H0 : p1 = p2 \]||||.29
72480001|NCT02401867|144486175|SUPERIORITY_OR_OTHER||Kappa|0.75|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|0.58|0.92||A priori threshold: p\<0.05|Kappa||Using the asymptotic standard error assuming the null hypothesis.|Concordance of HPV DNA detection between self-swab and provider swab assessed via an unweighted Kappa (K) statistic to determine the percentage agreement beyond that expected by chance.||0.92|0.58|<0.001
72480002|NCT02401867|144486175|SUPERIORITY_OR_OTHER||Sensitivity|71.43|||||TWO_SIDED|95.0|47.82|88.72|||||Used exact confidence intervals.|Assessed sensitivity of vaginal self-swab HPV DNA with respect to provider cervical HPV DNA (reference test).||88.72|47.82|
72509900|NCT05372575|144550705|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|17.98|||||TWO_SIDED|95.0|12.07|26.78|||||GMR=(GMC of 13vPnC Cohort)/(GMC of Non-13vPnC Cohort)|GMR of 13vPnC Cohort/Non-13vPnC Cohort for Serotype: 4||26.78|12.07|
72623696|NCT00023595|144778211|SUPERIORITY|24 months||||||0.028|||||||Chi-squared|||||||0.028
72480003|NCT02401867|144486175|NON_INFERIORITY_OR_EQUIVALENCE|Assessed specificity of vaginal self-swab HPV DNA with respect to provider cervical HPV DNA (reference test).|Specificity|98.18|||||TWO_SIDED|95.0|93.59|99.78|||||Used exact confidence intervals.|||99.78|93.59|
72480004|NCT02401867|144486175|SUPERIORITY_OR_OTHER||Positive Predictive Value|88.24|||||TWO_SIDED|95.0|63.56|98.54|||||Used exact confidence intervals.|Assessed positive predictive value of vaginal self-swab HPV DNA with respect to provider cervical HPV DNA (reference test).||98.54|63.56|
72480005|NCT02401867|144486175|SUPERIORITY_OR_OTHER||Negative predictive value|94.74|||||TWO_SIDED|95.0|88.9|98.04|||||Used exact confidence intervals|Assessed negative predictive value of vaginal self-swab HPV DNA with respect to provider cervical HPV DNA (reference test).||98.04|88.90|
72480006|NCT02795429|144486181|SUPERIORITY||Odds Ratio (OR)|0.561|||||||||||Bayesian Logistic Regression Model||Posterior probability that the odds ratio (ORRspartalizumab +capmatinib to ORRspartalizumab) was ≥ 1|||||
72480007|NCT00362453|144486209|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-118.8||||0.0005|TWO_SIDED|95.0|-183.66|-53.94|||Mixed Models Analysis|||||-53.94|-183.66|0.0005
72480008|NCT00362453|144486210|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-324.6||||0.001|TWO_SIDED|95.0|-513.98|-135.22|||Mixed Models Analysis|||12 Week||-135.22|-513.98|0.001
72623697|NCT00023595|144778211|SUPERIORITY|||||||0.079||||||36 months|Chi-squared|||||||0.079
72623698|NCT00023595|144778212|SUPERIORITY|||||||0.74||||||Baseline|Wilcoxon (Mann-Whitney)|||||||0.74
72480009|NCT00362453|144486210|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-183.2||||0.06|TWO_SIDED|95.0|-372.58|6.18|||Mixed Models Analysis|||24 Week||6.18|-372.58|0.06
72480010|NCT00362453|144486210|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-105.3||||0.3|TWO_SIDED|95.0|-294.68|84.08|||Mixed Models Analysis|||48 week||84.08|-294.68|0.3
72480011|NCT00362453|144486211|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-22.9||||0.1|TWO_SIDED|95.0|-53.04|7.24|||Mixed Models Analysis|||12 week||7.24|-53.04|0.1
72480012|NCT00362453|144486211|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.8||||0.3|TWO_SIDED|95.0|-44.94|15.34|||Mixed Models Analysis|||24 week||15.34|-44.94|0.3
72480013|NCT00362453|144486211|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.65||||0.8|TWO_SIDED|95.0|-33.79|26.49|||Mixed Models Analysis|||48 Week||26.49|-33.79|0.8
72480014|NCT00362453|144486212|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-66.95||||0.05|TWO_SIDED|95.0|-131.81|-2.09|||Mixed Models Analysis|||24 Week||-2.09|-131.81|0.05
72480015|NCT00362453|144486212|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-46.15||||0.2|TWO_SIDED|95.0|-111.01|18.71|||Mixed Models Analysis|||48 Week||18.71|-111.01|0.2
72480016|NCT00362453|144486213|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.15||||0.01|TWO_SIDED|95.0|-3.82|-0.49|||Mixed Models Analysis|||12 Week||-0.49|-3.82|0.01
72480017|NCT00362453|144486213|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.65||||0.4|TWO_SIDED|95.0|-2.31|1.02|||Mixed Models Analysis|||24 Week||1.02|-2.31|0.4
72400551|NCT00975481|144308992|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-22.7673|||<|0.0001|TWO_SIDED|95.0|-28.7925|-16.7422||Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.|Mixed Models Analysis|||For Emax, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-16.7422|-28.7925|<0.0001
72400552|NCT00975481|144308992|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.7524|||<|0.0001|TWO_SIDED|95.0|-25.8485|-13.6563|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emax, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-13.6563|-25.8485|<0.0001
72400553|NCT00975481|144308992|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.0888||||0.0006|TWO_SIDED|95.0|5.3225|18.8551|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emin, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||18.8551|5.3225|0.0006
72400554|NCT00975481|144308992|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.0768||||0.0038|TWO_SIDED|95.0|3.3132|16.8403|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emin, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||16.8403|3.3132|0.0038
72400555|NCT00975481|144308992|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.1875||||0.2257|TWO_SIDED|95.0|-10.989|2.6139|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emin, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||2.6139|-10.9890|0.2257
72400556|NCT00975481|144308992|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8589||||0.8042|TWO_SIDED|95.0|-7.6927|5.975|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emin, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||5.9750|-7.6927|0.8042
72480018|NCT00362453|144486213|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.04||||1|TWO_SIDED|95.0|-1.62|1.7|||Mixed Models Analysis|||48 weeks||1.70|-1.62|1.0
72480019|NCT00362453|144486214|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.71||||0.002|TWO_SIDED|95.0|-2.75|-0.66|||Mixed Models Analysis|||12 Week||-0.66|-2.75|0.002
72480020|NCT00362453|144486214|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.53||||0.3|TWO_SIDED|95.0|-1.58|0.51|||Mixed Models Analysis|||24 Week||0.51|-1.58|0.3
72480021|NCT00362453|144486214|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.03||||0.06|TWO_SIDED|95.0|-2.09|0.02|||Mixed Models Analysis|||48 Week||0.02|-2.09|0.06
72480022|NCT00362453|144486215|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.88||||5e-05|TWO_SIDED|95.0|-15.91|-5.84|||Mixed Models Analysis|||12 Week||-5.84|-15.91|0.00005
72480023|NCT00362453|144486215|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.12||||0.05|TWO_SIDED|95.0|-10.15|-0.08|||Mixed Models Analysis|||24 Week||-0.08|-10.15|0.05
72480024|NCT00362453|144486215|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.98||||0.02|TWO_SIDED|95.0|-11.06|-0.91|||Mixed Models Analysis|||48 Week||-0.91|-11.06|0.02
72480025|NCT00362453|144486216|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|50.08||||0.1|TWO_SIDED|95.0|-10.34|110.5|||Mixed Models Analysis|||12 Week||110.50|-10.34|0.1
72480026|NCT00362453|144486216|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|43.71||||0.1|TWO_SIDED|95.0|-15.07|102.5|||Mixed Models Analysis|||24 Week||102.50|-15.07|0.1
72480027|NCT00362453|144486216|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.61||||0.7|TWO_SIDED|95.0|-49.36|78.59|||Mixed Models Analysis|||48 Weeks||78.59|-49.36|0.7
72623699|NCT00023595|144778212|SUPERIORITY|||||||0.61||||||4 months|Wilcoxon (Mann-Whitney)|||||||0.61
72480028|NCT00362453|144486217|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.7|TWO_SIDED|95.0|-0.54|0.34|||Mixed Models Analysis|||12 Weeks||0.34|-0.54|0.7
72480029|NCT00362453|144486217|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.07||||0.7|TWO_SIDED|95.0|-0.37|0.52|||Mixed Models Analysis|||24 Weeks||0.52|-0.37|0.7
72480030|NCT00362453|144486217|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.11||||0.6|TWO_SIDED|95.0|-0.55|0.34|||Mixed Models Analysis|||48 weeks||0.34|-0.55|0.6
72480031|NCT00362453|144486218|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.7||||0.009|TWO_SIDED|95.0|-11.63|-1.77|||Mixed Models Analysis|||12 Week||-1.77|-11.63|0.009
72480032|NCT00362453|144486218|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.3||||0.04|TWO_SIDED|95.0|-10.23|-0.37|||Mixed Models Analysis|||24 Weeks||-0.37|-10.23|0.04
72480033|NCT00362453|144486218|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.9||||0.0006|TWO_SIDED|95.0|-13.83|-3.97|||Mixed Models Analysis|||48 Week||-3.97|-13.83|0.0006
72480034|NCT00362453|144486219|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.71||||0.04|TWO_SIDED|95.0|0.03|1.39|||Mixed Models Analysis|||12 Weeks||1.39|0.03|0.04
72623700|NCT00023595|144778212|SUPERIORITY|||||||0.78|||||||Wilcoxon (Mann-Whitney)|||||||0.78
72623701|NCT00023595|144778212|SUPERIORITY|||||||0.94||||||24 months|Wilcoxon (Mann-Whitney)|||||||0.94
72623702|NCT00023595|144778212|SUPERIORITY|||||||0.29||||||36 months|Wilcoxon (Mann-Whitney)|||||||0.29
72623703|NCT00023595|144778213|SUPERIORITY|||||||0.063||||||4 months|Chi-squared|H01 P-values were based on the Chi-Square test applied to maximum likelihood estimates derived from an adjusted mixed model.||||||0.063
72623704|NCT00023595|144778213|SUPERIORITY|||||||0.187||||||12 months|Chi-squared|||||||0.187
72400557|NCT00975481|144308992|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.6335||||0.6399|TWO_SIDED|95.0|-8.5177|5.2506|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emin, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||5.2506|-8.5177|0.6399
72400558|NCT00975481|144308992|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.2763|||<|0.0001|TWO_SIDED|95.0|-23.0228|-9.5229|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emin, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-9.5229|-23.0228|<0.0001
72400559|NCT00975481|144308992|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.9477||||0.0002|TWO_SIDED|95.0|-19.7374|-6.158|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emin, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-6.1580|-19.7374|0.0002
72400560|NCT00975481|144308992|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.7223||||0.0001|TWO_SIDED|95.0|-20.572|-6.8727|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emin, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-6.8727|-20.5720|0.0001
72400561|NCT00975481|144308992|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.2643|||<|0.0001|TWO_SIDED|95.0|-20.9226|-7.606|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emin, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-7.6060|-20.9226|<0.0001
72400562|NCT00975481|144308992|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.9356||||0.0016|TWO_SIDED|95.0|-17.6548|-4.2165|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emin, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-4.2165|-17.6548|0.0016
72400563|NCT00975481|144308992|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.7103||||0.0008|TWO_SIDED|95.0|-18.5055|-4.9151|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emin, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-4.9151|-18.5055|0.0008
72480035|NCT00362453|144486219|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.85||||0.02|TWO_SIDED|95.0|0.17|1.53|||Mixed Models Analysis|||24 Weeks||1.53|0.17|0.02
72480036|NCT00362453|144486219|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.96||||0.007|TWO_SIDED|95.0|0.28|1.64|||Mixed Models Analysis|||48 Weeks||1.64|0.28|0.007
72480037|NCT00362453|144486220|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.43||||0.004|TWO_SIDED|95.0|2.5|12.36|||Mixed Models Analysis|||12 Weeks||12.36|2.50|0.004
72480038|NCT00362453|144486220|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.51||||0.08|TWO_SIDED|95.0|-0.42|9.45|||Mixed Models Analysis|||24 Weeks||9.45|-0.42|0.08
72480039|NCT00362453|144486220|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.32||||0.01|TWO_SIDED|95.0|1.38|11.25|||Mixed Models Analysis|||48 Weeks||11.25|1.38|0.01
72480040|NCT00362453|144486221|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.21||||0.9|TWO_SIDED|95.0|-6.15|6.57|||Mixed Models Analysis|||12 Weeks||6.57|-6.15|0.9
72480041|NCT00362453|144486221|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.11||||1|TWO_SIDED|95.0|-6.47|6.25|||Mixed Models Analysis|||24 Weeks||6.25|-6.47|1.0
72480042|NCT00362453|144486221|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.77||||0.1|TWO_SIDED|95.0|-1.59|11.13|||Mixed Models Analysis|||48 Weeks||11.13|-1.59|0.10
72480043|NCT02047643|144486247|OTHER|||||||0.45|||||||Fisher Exact|Two-sided Fisher Exact test||||||.45
72480044|NCT02047643|144486248|OTHER|||||||0.66|||||||Fisher Exact|Two-sided Fisher Exact test||||||.66
72480045|NCT00120406|144486270|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin is 10%.|||||<|0.01||95.0||||P-value has been adjusted for multiplicity.|z-test, one-sided|||||||<0.01
72480046|NCT00120406|144486271|SUPERIORITY_OR_OTHER||||||<|0.01||95.0||||P-value has been adjusted for multiplicity.|Generalized estimating equation (GEE)|||||||<0.01
72480047|NCT03907410|144486339|SUPERIORITY||Mean Difference (Final Values)|15.0|||||TWO_SIDED|95.0|2.0|28.0||||||Multivariate comparison of Experiment phase adherence (Months 1-3) comparing Arm 1 (Full Intervention arm) to Arm 3 (Active control). Arm 3 is used as the reference. This randomized controlled trial was powered for Arm 1 vs. Arm 3 comparisons, hence the Arm 1 vs. Arm 3 outcome data for adherence to the inhaled corticosteroid regime. The study did not have sufficient power for Arm 2 comparisons.||28|2|
72480048|NCT03907410|144486339|SUPERIORITY||Mean Difference (Final Values)|-6.0|||||TWO_SIDED|95.0|-20.0|7.0||||||Multivariate comparison of Observation phase adherence (Months 4-6) comparing Arm 1 (Full Intervention arm) to Arm 3 (Active control). Arm 3 is used as the reference. This randomized controlled trial was powered for Arm 1 vs. Arm 3 comparisons, hence the Arm 1 vs. Arm 3 outcome data for adherence to the inhaled corticosteroid regime. The study did not have sufficient power for Arm 2 comparisons.||7|-20|
72480049|NCT04218084|144486373|OTHER|Mixed Model Repeated Measures analysis|Difference in LS mean|-7.73||||0.0043|TWO_SIDED|95.0|-13.03|-2.42|||Mixed Models for Repeated Measures|||Week 24||-2.42|-13.03|0.0043
72623705|NCT00023595|144778213|SUPERIORITY|||||||0.168||||||24 months|Chi-squared|||||||0.168
72480050|NCT00712673|144486398|SUPERIORITY_OR_OTHER||Least squares (LS) mean difference|-0.48|STANDARD_ERROR_OF_MEAN|0.088|<|0.0001|TWO_SIDED|95.0|-0.657|-0.312||Stepwise testing procedure applied to control type 1 error: lixisenatide (morning) compared with placebo (combined), if found statistically significant, then lixisenatide (evening) compared with placebo (combined).|ANCOVA|||To detect 0.5%(or 0.4%) difference between 1 lixisenatide arm and placebo(combined), 225 patients in lixisenatide arm, 170 in placebo(combined) would provide a power of 97% (or 87%) assuming common standard deviation=1.3% with 2-sided test at 5% significance. Statistical testing:2-sided at significance level=0.05. Analysis of co-variance(ANCOVA)included treatment arms, randomization strata of screening HbA1c(\<8.0,\>=8.0%),BMI(\<30,\>=30 kg/m\^2),country as fixed effects, baseline HbA1c as covariate.||-0.312|-0.657|<0.0001
72509901|NCT05372575|144550705|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|2.42|||||TWO_SIDED|95.0|1.9|3.08|||||GMR=(GMC of 13vPnC Cohort)/(GMC of Non-13vPnC Cohort)|GMR of 13vPnC Cohort/Non-13vPnC Cohort for Serotype: 5||3.08|1.90|
72509902|NCT05372575|144550705|SUPERIORITY|The 2-sided 95% CI on GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|6.35|||||TWO_SIDED|95.0|4.68|8.61|||||GMR=(GMC of 13vPnC Cohort)/(GMC of Non-13vPnC Cohort)|GMR of 13vPnC Cohort/Non-13vPnC Cohort for Serotype: 6A||8.61|4.68|
72509903|NCT05372575|144550705|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|6.64|||||TWO_SIDED|95.0|4.92|8.97|||||GMR=(GMC of 13vPnC Cohort)/(GMC of Non-13vPnC Cohort)|GMR of 13vPnC Cohort/Non-13vPnC Cohort for Serotype: 6B||8.97|4.92|
72509904|NCT05372575|144550705|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|9.42|||||TWO_SIDED|95.0|6.91|12.83|||||GMR=(GMC of 13vPnC Cohort)/(GMC of Non-13vPnC Cohort)|GMR of 13vPnC Cohort/Non-13vPnC Cohort for Serotype: 7F||12.83|6.91|
72509905|NCT05372575|144550705|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|3.89|||||TWO_SIDED|95.0|2.96|5.1|||||GMR=(GMC of 13vPnC Cohort)/(GMC of Non-13vPnC Cohort)|GMR of 13vPnC Cohort/Non-13vPnC Cohort for Serotype: 9V||5.10|2.96|
72509906|NCT05372575|144550705|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|62.13|||||TWO_SIDED|95.0|40.16|96.12|||||GMR=(GMC of 13vPnC Cohort)/(GMC of Non-13vPnC Cohort)|GMR of 13vPnC Cohort/Non-13vPnC Cohort for Serotype: 14||96.12|40.16|
72566643|NCT00262041|144663610|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority of MenACWY Ad+ vaccine against the serogroup A was assessed to that of the MenACWY PS vaccine if the lower limit of the two-sided 95% CI around the difference in proportions was greater than -10%.|||||<|0.001||95.0|||||Chi-squared|||To demonstrate non-inferiority of percentages of subjects with hSBA titer ≥ 1:4 who received MenACWY Ad+ vaccine group against serogroup A compared with that of MenACWY PS vaccine.||||<0.001
72566644|NCT00262041|144663610|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority of MenACWY Ad- vaccine against the serogroup A was assessed to that of the MenACWY PS vaccine if the lower limit of the two-sided 95% CI around the difference in proportions was greater than -10%.|||||<|0.001||95.0|||||Chi-squared|||To demonstrate non-inferiority of percentages of subjects with hSBA titer ≥ 1:4 who received MenACWY Ad- vaccine group against serogroup A compared with that of MenACWY PS vaccine.||||<0.001
72509907|NCT05372575|144550705|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|16.37|||||TWO_SIDED|95.0|11.22|23.89|||||GMR=(GMC of 13vPnC Cohort)/(GMC of Non-13vPnC Cohort)|GMR of 13vPnC Cohort/Non-13vPnC Cohort for Serotype: 18C||23.89|11.22|
72509908|NCT05372575|144550705|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|4.25|||||TWO_SIDED|95.0|3.22|5.62|||||GMR=(GMC of 13vPnC Cohort)/(GMC of Non-13vPnC Cohort)|GMR of 13vPnC Cohort/Non-13vPnC Cohort for Serotype: 19A||5.62|3.22|
72509909|NCT05372575|144550705|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|8.73|||||TWO_SIDED|95.0|6.24|12.21|||||GMR=(GMC of 13vPnC Cohort)/(GMC of Non-13vPnC Cohort)|GMR of 13vPnC Cohort/Non-13vPnC Cohort for Serotype: 19F||12.21|6.24|
72509910|NCT05372575|144550705|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|8.33|||||TWO_SIDED|95.0|6.15|11.29|||||GMR=(GMC of 13vPnC Cohort)/(GMC of Non-13vPnC Cohort)|GMR of 13vPnC Cohort/Non-13vPnC Cohort for Serotype: 23F||11.29|6.15|
72509911|NCT05372575|144550706|SUPERIORITY|The 2-sided 95% CI on the GMR (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|Geometric Mean Ratio (GMR)|4.78|||||TWO_SIDED|95.0|2.32|9.86|||||GMR=(GMT of 13vPnC Cohort)/(GMT of Non-13vPnC Cohort)|GMR of 13vPnC Cohort/Non-13vPnC Cohort for Serotype: 1||9.86|2.32|
72480051|NCT00712673|144486398|SUPERIORITY_OR_OTHER||LS mean difference|-0.37|STANDARD_ERROR_OF_MEAN|0.088|<|0.0001|TWO_SIDED|95.0|-0.54|-0.193||Stepwise testing procedure applied to control type 1 error: lixisenatide (morning) compared with placebo (combined), if found statistically significant, then lixisenatide (evening) compared with placebo (combined).|ANCOVA|||To detect 0.5%(or 0.4%) difference between 1 lixisenatide arm and placebo(combined), 225 patients in lixisenatide arm, 170 in placebo(combined) would provide a power of 97% (or 87%) assuming common standard deviation=1.3% with 2-sided test at 5% significance. Statistical testing:2-sided at significance level=0.05. Analysis of co-variance(ANCOVA)included treatment arms, randomization strata of screening HbA1c(\<8.0,\>=8.0%),BMI(\<30,\>=30 kg/m\^2),country as fixed effects, baseline HbA1c as covariate.||-0.193|-0.540|<0.0001
72509912|NCT05372575|144550706|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|9.06|||||TWO_SIDED|95.0|4.72|17.39|||||GMR=(GMT of 13vPnC Cohort)/(GMT of Non-13vPnC Cohort)|GMR of 13vPnC Cohort/Non-13vPnC Cohort for Serotype: 3||17.39|4.72|
72509913|NCT05372575|144550706|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|14.37|||||TWO_SIDED|95.0|6.25|33.05|||||GMR=(GMT of 13vPnC Cohort)/(GMT of Non-13vPnC Cohort)|GMR of 13vPnC Cohort/Non-13vPnC Cohort for Serotype: 4||33.05|6.25|
72509914|NCT05372575|144550706|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|18.03|||||TWO_SIDED|95.0|8.84|36.8|||||GMR=(GMT of 13vPnC Cohort)/(GMT of Non-13vPnC Cohort)|GMR of 13vPnC Cohort/Non-13vPnC Cohort for Serotype: 5||36.80|8.84|
72509915|NCT05372575|144550706|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|33.88|||||TWO_SIDED|95.0|14.33|80.13|||||GMR=(GMT of 13vPnC Cohort)/(GMT of Non-13vPnC Cohort)|GMR of 13vPnC Cohort/Non-13vPnC Cohort for Serotype: 6A||80.13|14.33|
72509916|NCT05372575|144550706|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|14.05|||||TWO_SIDED|95.0|6.07|32.52|||||GMR=(GMT of 13vPnC Cohort)/(GMT of Non-13vPnC Cohort)|GMR of 13vPnC Cohort/Non-13vPnC Cohort for Serotype: 6B||32.52|6.07|
72509917|NCT05372575|144550706|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|16.99|||||TWO_SIDED|95.0|7.85|36.76|||||GMR=(GMT of 13vPnC Cohort)/(GMT of Non-13vPnC Cohort)|GMR of 13vPnC Cohort/Non-13vPnC Cohort for Serotype: 7F||36.76|7.85|
72566645|NCT00262041|144663610|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority of MenACWY Ad+ vaccine against the serogroup C was assessed to that of the MenACWY PS vaccine if the lower limit of the two-sided 95% CI around the difference in proportions was greater than -10%.|||||<|0.001||95.0|||||Chi-squared|||To demonstrate non-inferiority of percentages of subjects with hSBA titer ≥ 1:4 who received MenACWY Ad+ vaccine group against serogroup C compared with that of MenACWY PS vaccine.||||<0.001
72509918|NCT05372575|144550706|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|19.31|||||TWO_SIDED|95.0|9.13|40.84|||||GMR=(GMT of 13vPnC Cohort)/(GMT of Non-13vPnC Cohort)|GMR of 13vPnC Cohort/Non-13vPnC Cohort for Serotype: 9V||40.84|9.13|
72509919|NCT05372575|144550706|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|10.46|||||TWO_SIDED|95.0|4.74|23.1|||||GMR=(GMT of 13vPnC Cohort)/(GMT of Non-13vPnC Cohort)|GMR of 13vPnC Cohort/Non-13vPnC Cohort for Serotype: 14||23.10|4.74|
72509920|NCT05372575|144550706|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|12.13|||||TWO_SIDED|95.0|6.0|24.51|||||GMR=(GMT of 13vPnC Cohort)/(GMT of Non-13vPnC Cohort)|GMR of 13vPnC Cohort/Non-13vPnC Cohort for Serotype: 18C||24.51|6.00|
72509921|NCT05372575|144550706|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|23.65|||||TWO_SIDED|95.0|10.94|51.1|||||GMR=(GMT of 13vPnC Cohort)/(GMT of Non-13vPnC Cohort)|GMR of 13vPnC Cohort/Non-13vPnC Cohort for Serotype: 19A||51.10|10.94|
72509922|NCT05372575|144550706|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|17.62|||||TWO_SIDED|95.0|8.65|35.93|||||GMR=(GMT of 13vPnC Cohort)/(GMT of Non-13vPnC Cohort)|GMR of 13vPnC Cohort/Non-13vPnC Cohort for Serotype: 19F||35.93|8.65|
72509923|NCT05372575|144550706|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|44.46|||||TWO_SIDED|95.0|19.11|103.43|||||GMR=(GMT of 13vPnC Cohort)/(GMT of Non-13vPnC Cohort)|GMR of 13vPnC Cohort/Non-13vPnC Cohort for Serotype: 23F||103.43|19.11|
72509924|NCT05372575|144550707|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|Geometric Mean Ratio (GMR)|0.48|||||TWO_SIDED|95.0|0.16|1.42|||||GMR=(GMC of VT+ Subgroup)/(GMC of VT- or Sp- Subgroup)|GMR of VT+ Subgroup/VT- or Sp- Subgroup in 13vPnC Cohort for Serotype: 1||1.42|0.16|
72509925|NCT05372575|144550707|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|0.74|||||TWO_SIDED|95.0|0.27|1.98|||||GMR=(GMC of VT+ Subgroup)/(GMC of VT- or Sp- Subgroup)|GMR of VT+ Subgroup/VT- or Sp- Subgroup in 13vPnC Cohort for Serotype: 3||1.98|0.27|
72509926|NCT05372575|144550707|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|0.68|||||TWO_SIDED|95.0|0.21|2.19|||||GMR=(GMC of VT+ Subgroup)/(GMC of VT- or Sp- Subgroup)|GMR of VT+ Subgroup/VT- or Sp- Subgroup in 13vPnC Cohort for Serotype: 4||2.19|0.21|
72509927|NCT05372575|144550707|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|0.82|||||TWO_SIDED|95.0|0.36|1.86|||||GMR=(GMC of VT+ Subgroup)/(GMC of VT- or Sp- Subgroup)|GMR of VT+ Subgroup/VT- or Sp- Subgroup in 13vPnC Cohort for Serotype: 5||1.86|0.36|
72623706|NCT00023595|144778213|SUPERIORITY|||||||0.05||||||36 months|Chi-squared|||||||0.050
72623707|NCT00023595|144778214|SUPERIORITY|||||||0.82||||||Baseline|Wilcoxon (Mann-Whitney)|||||||0.82
72509928|NCT05372575|144550707|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|0.68|||||TWO_SIDED|95.0|0.25|1.89|||||GMR=(GMC of VT+ Subgroup)/(GMC of VT- or Sp- Subgroup)|GMR of VT+ Subgroup/VT- or Sp- Subgroup in 13vPnC Cohort for Serotype: 6A||1.89|0.25|
72623708|NCT00023595|144778214|SUPERIORITY|||||||0.48||||||4 months|Wilcoxon (Mann-Whitney)|||||||0.48
72480052|NCT01468831|144486420|OTHER|The mean difference between the minocycline and placebo arms in change in BCVA in the study eye at Month 12 compared to baseline is reported.|Mean Difference (Net)|7.8|STANDARD_DEVIATION|7.4|||TWO_SIDED|95.0|-10.6|26.1|||||Difference = Minocycline - Placebo|||26.1|-10.6|
72480053|NCT01468831|144486421|OTHER|The mean difference between the minocycline and placebo treatment arms in number of bevacizumab injections received from baseline to Month 12 is reported.|Mean Difference (Net)|1.1|STANDARD_DEVIATION|1.4|||TWO_SIDED||||||||Difference = Minocycline - Placebo|||||
72480054|NCT01468831|144486422|OTHER||Mean Difference (Net)|-0.2|STANDARD_DEVIATION|3.5|||TWO_SIDED||||||||Difference = Minocycline - Placebo|The mean difference between the minocycline and placebo treatment arms in number of bevacizumab injections received from baseline to Month 24 is reported.||||
72480055|NCT01468831|144486423|OTHER|The mean difference between the minocycline and placebo groups in the change in macular sensitivity in the study eye at Month 3 compared to baseline is reported.|Mean Difference (Net)|-0.8|STANDARD_DEVIATION|1.3|||TWO_SIDED|95.0|-3.9|2.3|||||Difference = Minocycline - Placebo|||2.3|-3.9|
72480056|NCT01468831|144486424|OTHER|The mean difference between the minocycline and placebo groups in the change in macular sensitivity in the study eye at Month 6 compared to baseline is reported.|Mean Difference (Net)|-2.1|STANDARD_DEVIATION|1.0|||TWO_SIDED|95.0|-4.5|0.3|||||Difference = Minocycline - Placebo|||0.3|-4.5|
72480057|NCT01468831|144486425|OTHER|The mean difference between the minocycline and placebo groups in the change in macular sensitivity in the study eye at Month 12 compared to baseline is reported.|Mean Difference (Net)|-2.5|STANDARD_DEVIATION|1.8|||TWO_SIDED|95.0|-7.5|2.5|||||Difference = Minocycline - Placebo|||2.5|-7.5|
72480058|NCT01468831|144486426|OTHER|The mean difference between the minocycline and placebo groups in the change in macular sensitivity in the study eye at Month 18 compared to baseline is reported.|Mean Difference (Net)|-3.5|STANDARD_DEVIATION|2.2|||TWO_SIDED|95.0|-9.4|2.4|||||Difference = Minocycline - Placebo|||2.4|-9.4|
72480059|NCT01468831|144486427|OTHER|The mean difference between the minocycline and placebo groups in the change in macular sensitivity in the study eye at Month 24 compared to baseline is reported.|Mean Difference (Net)|-3.7|STANDARD_DEVIATION|2.4|||TWO_SIDED|95.0|-9.5|2.0|||||Difference = Minocycline - Placebo|||2|-9.5|
72509929|NCT05372575|144550707|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|0.74|||||TWO_SIDED|95.0|0.27|2.07|||||GMR=(GMC of VT+ Subgroup)/(GMC of VT- or Sp- Subgroup)|GMR of VT+ Subgroup/VT- or Sp- Subgroup in 13vPnC Cohort for Serotype: 6B||2.07|0.27|
72566646|NCT00262041|144663610|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority of MenACWY Ad- vaccine against the serogroup C was assessed to that of the MenACWY PS vaccine if the lower limit of the two-sided 95% CI around the difference in proportions was greater than -10%.||||||0.003||95.0|||||Chi-squared|||To demonstrate non-inferiority of percentages of subjects with hSBA titer ≥ 1:4 who received MenACWY Ad- vaccine group against serogroup C compared with that of MenACWY PS vaccine.||||0.003
72566647|NCT00262041|144663610|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority of MenACWY Ad+ vaccine against the serogroup W was assessed to that of the MenACWY PS vaccine if the lower limit of the two-sided 95% CI around the difference in proportions was greater than -10%.|||||<|0.001||95.0|||||Chi-squared|||To demonstrate non-inferiority of percentages of subjects with hSBA titer ≥ 1:4 who received MenACWY Ad+ vaccine group against serogroup W compared with that of MenACWY PS vaccine.||||<0.001
72566648|NCT00262041|144663610|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority of MenACWY Ad- vaccine against the serogroup W was assessed to that of the MenACWY PS vaccine if the lower limit of the two-sided 95% CI around the difference in proportions was greater than -10%.||||||0.071||95.0|||||Chi-squared|||To demonstrate non-inferiority of percentages of subjects with hSBA titer ≥ 1:4 who received MenACWY Ad- vaccine group against serogroup W compared with that of MenACWY PS vaccine.||||0.071
72400564|NCT00975481|144308993|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|24.009|||<|0.0001|TWO_SIDED|95.0|13.7265|34.2916|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||34.2916|13.7265|<0.0001
72400565|NCT00975481|144308993|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|29.4156|||<|0.0001|TWO_SIDED|95.0|19.116|39.7151|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||39.7151|19.1160|<0.0001
72400566|NCT00975481|144308993|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.3979||||0.2239|TWO_SIDED|95.0|-16.7479|3.9521|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||3.9521|-16.7479|0.2239
72400567|NCT00975481|144308993|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.1396||||0.4326|TWO_SIDED|95.0|-14.5328|6.2526|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||6.2526|-14.5328|0.4326
72400568|NCT00975481|144308993|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.7283||||0.7447|TWO_SIDED|95.0|-12.195|8.7383|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||8.7383|-12.1950|0.7447
72400569|NCT00975481|144308993|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-30.4069|||<|0.0001|TWO_SIDED|95.0|-40.6795|-20.1343|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-20.1343|-40.6795|<0.0001
72480060|NCT01468831|144486428|OTHER|The mean difference between the minocycline and placebo arms in change in BCVA in the study eye at Month 24 compared to baseline is reported.|Mean Difference (Net)|5.8|STANDARD_DEVIATION|9.1|||TWO_SIDED|95.0|-17.1|28.6|||||Difference = Minocycline - Placebo|||28.6|-17.1|
72480061|NCT01468831|144486429|OTHER|The mean difference between the minocycline and placebo treatment arms in change in retinal thickness as measured by OCT in the study eye at Month 6 compared to baseline is reported.|Mean Difference (Net)|-51.8|STANDARD_DEVIATION|70.8|||TWO_SIDED|95.0|-231.2|127.6|||||Difference = Minocycline - Placebo|||127.6|-231.2|
72480062|NCT01468831|144486430|OTHER|The mean difference between the minocycline and placebo treatment arms in change in retinal thickness as measured by OCT in the study eye at Month 12 compared to baseline is reported.|Mean Difference (Net)|-45.5|STANDARD_DEVIATION|153.5|||TWO_SIDED|95.0|-522.6|431.6|||||Difference = Minocycline - Placebo|||431.6|-522.6|
72509930|NCT05372575|144550707|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|0.42|||||TWO_SIDED|95.0|0.16|1.09|||||GMR=(GMC of VT+ Subgroup)/(GMC of VT- or Sp- Subgroup)|GMR of VT+ Subgroup/VT- or Sp- Subgroup in 13vPnC Cohort for Serotype: 7F||1.09|0.16|
72400570|NCT00975481|144308993|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-28.1487|||<|0.0001|TWO_SIDED|95.0|-38.4812|-17.8161|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-17.8161|-38.4812|<0.0001
72623709|NCT00023595|144778214|SUPERIORITY|||||||0.69||||||12 months|Wilcoxon (Mann-Whitney)|||||||0.69
72480063|NCT01468831|144486431|OTHER|The mean difference between the minocycline and placebo treatment arms in change in retinal thickness as measured by OCT in the study eye at Month 18 compared to baseline is reported.|Mean Difference (Net)|-12.8|STANDARD_DEVIATION|163.8|||TWO_SIDED|95.0|-513.1|487.6|||||Difference = Minocycline - Placebo|||487.6|-513.1|
72480064|NCT01468831|144486432|OTHER|The mean difference between the minocycline and placebo treatment arms in change in retinal thickness as measured by OCT in the study eye at Month 24 compared to baseline is reported.|Mean Difference (Net)|-9.5|STANDARD_DEVIATION|156.8|||TWO_SIDED|95.0|-487.0|468.0|||||Difference = Minocycline - Placebo|||468|-487|
72480065|NCT01468831|144486433|OTHER|The difference between the minocycline and placebo treatment arms in number of participants improving ≥ 1 logOCT scale step in the study eye at Month 12 compared to baseline is reported.|Difference in Number of Participants|1.0|||||TWO_SIDED||||||||Difference = Minocycline - Placebo|||||
72480066|NCT01468831|144486434|OTHER|The difference between the minocycline and placebo treatment arms in number of participants improving ≥ 1 logOCT scale step in the study eye at Month 24 compared to baseline is reported|Difference in Number of Participants|0.0|||||TWO_SIDED||||||||Difference = Minocycline - Placebo|||||
72480067|NCT01468831|144486435|OTHER|The difference between the minocycline and treatment arms in the number of participants experiencing a decrease in fluid leakage at Month 12 compared to baseline is reported.|Difference in Number of Participants|-2.0|||||TWO_SIDED||||||||Difference = Minocycline - Placebo|||||
72623710|NCT00023595|144778214|SUPERIORITY|||||||0.63||||||24 months|Wilcoxon (Mann-Whitney)|||||||0.63
72400571|NCT00975481|144308993|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-25.7374|||<|0.0001|TWO_SIDED|95.0|-36.1651|-15.3096|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-15.3096|-36.1651|<0.0001
72509931|NCT05372575|144550707|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|0.8|||||TWO_SIDED|95.0|0.35|1.81|||||GMR=(GMC of VT+ Subgroup)/(GMC of VT- or Sp- Subgroup)|GMR of VT+ Subgroup/VT- or Sp- Subgroup in 13vPnC Cohort for Serotype: 9V||1.81|0.35|
72509932|NCT05372575|144550707|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|0.66|||||TWO_SIDED|95.0|0.2|2.24|||||GMR=(GMC of VT+ Subgroup)/(GMC of VT- or Sp- Subgroup)|GMR of VT+ Subgroup/VT- or Sp- Subgroup in 13vPnC Cohort for Serotype: 14||2.24|0.20|
72509933|NCT05372575|144550707|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|0.6|||||TWO_SIDED|95.0|0.22|1.65|||||GMR=(GMC of VT+ Subgroup)/(GMC of VT- or Sp- Subgroup)|GMR of VT+ Subgroup/VT- or Sp- Subgroup in 13vPnC Cohort for Serotype: 18C||1.65|0.22|
72509934|NCT05372575|144550707|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|1.55|||||TWO_SIDED|95.0|0.61|3.93|||||GMR=(GMC of VT+ Subgroup)/(GMC of VT- or Sp- Subgroup)|GMR of VT+ Subgroup/VT- or Sp- Subgroup in 13vPnC Cohort for Serotype: 19A||3.93|0.61|
72509935|NCT05372575|144550707|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|1.8|||||TWO_SIDED|95.0|0.65|4.99|||||GMR=(GMC of VT+ Subgroup)/(GMC of VT- or Sp- Subgroup)|GMR of VT+ Subgroup/VT- or Sp- Subgroup in 13vPnC Cohort for Serotype: 19F||4.99|0.65|
72400572|NCT00975481|144308993|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-35.8134|||<|0.0001|TWO_SIDED|95.0|-45.9257|-25.7012|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-25.7012|-45.9257|<0.0001
72509936|NCT05372575|144550707|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|0.47|||||TWO_SIDED|95.0|0.17|1.31|||||GMR=(GMC of VT+ Subgroup)/(GMC of VT- or Sp- Subgroup)|GMR of VT+ Subgroup/VT- or Sp- Subgroup in 13vPnC Cohort for Serotype: 23F||1.31|0.17|
72566649|NCT00262041|144663610|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority of MenACWY Ad+ vaccine against the serogroup Y was assessed to that of the MenACWY PS vaccine if the lower limit of the two-sided 95% CI around the difference in proportions was greater than -10%.|||||<|0.001||95.0|||||Chi-squared|||To demonstrate non-inferiority of percentages of subjects with hSBA titer ≥ 1:4 who received MenACWY Ad+ vaccine group against serogroup Y compared with that of MenACWY PS vaccine.||||<0.001
72566650|NCT00262041|144663610|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority of MenACWY Ad- vaccine against the serogroup Y was assessed to that of the MenACWY PS vaccine if the lower limit of the two-sided 95% CI around the difference in proportions was greater than -10%.|||||<|0.001||95.0|||||Chi-squared|||To demonstrate non-inferiority of percentages of subjects with hSBA titer ≥ 1:4 who received MenACWY Ad- vaccine group against serogroup Y compared with that of MenACWY PS vaccine.||||<0.001
72623711|NCT00023595|144778214|SUPERIORITY|||||||0.9||||||36 months|Wilcoxon (Mann-Whitney)|||||||0.90
72509937|NCT05372575|144550707|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|0.65|||||TWO_SIDED|95.0|0.31|1.38|||||GMR=(GMC of VT+ Subgroup)/(GMC of VT- or Sp- Subgroup)|GMR of VT+ Subgroup/VT- or Sp- Subgroup in non-13vPnC Cohort for Serotype: 1||1.38|0.31|
72509938|NCT05372575|144550707|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|0.7|||||TWO_SIDED|95.0|0.4|1.24|||||GMR=(GMC of VT+ Subgroup)/(GMC of VT- or Sp- Subgroup)|GMR of VT+ Subgroup/VT- or Sp- Subgroup in non-13vPnC Cohort for Serotype: 3||1.24|0.40|
72509939|NCT05372575|144550707|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|0.73|||||TWO_SIDED|95.0|0.33|1.59|||||GMR=(GMC of VT+ Subgroup)/(GMC of VT- or Sp- Subgroup)|GMR of VT+ Subgroup/VT- or Sp- Subgroup in non-13vPnC Cohort for Serotype: 4||1.59|0.33|
72509940|NCT05372575|144550707|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|0.8|||||TWO_SIDED|95.0|0.52|1.25|||||GMR=(GMC of VT+ Subgroup)/(GMC of VT- or Sp- Subgroup)|GMR of VT+ Subgroup/VT- or Sp- Subgroup in non-13vPnC Cohort for Serotype: 5||1.25|0.52|
72509941|NCT05372575|144550707|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|0.93|||||TWO_SIDED|95.0|0.57|1.52|||||GMR=(GMC of VT+ Subgroup)/(GMC of VT- or Sp- Subgroup)|GMR of VT+ Subgroup/VT- or Sp- Subgroup in non-13vPnC Cohort for Serotype: 6A||1.52|0.57|
72509942|NCT05372575|144550707|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|1.53|||||TWO_SIDED|95.0|0.95|2.47|||||GMR=(GMC of VT+ Subgroup)/(GMC of VT- or Sp- Subgroup)|GMR of VT+ Subgroup/VT- or Sp- Subgroup in non-13vPnC Cohort for Serotype: 6B||2.47|0.95|
72400573|NCT00975481|144308993|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-33.5552|||<|0.0001|TWO_SIDED|95.0|-43.7675|-23.3429|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-23.3429|-43.7675|<0.0001
72480068|NCT01468831|144486435|OTHER|The difference between the minocycline and treatment arms in the number of participants experiencing an increase in fluid leakage at Month 12 compared to baseline is reported.|Difference in Number of Participants|0.0|||||TWO_SIDED||||||||Difference = Minocycline - Placebo|||||
72480069|NCT01468831|144486435|OTHER|The difference between the minocycline and treatment arms in the number of participants experiencing no change in fluid leakage at Month 12 compared to baseline is reported.|Difference in Number of Participants|2.0|||||TWO_SIDED||||||||Difference = Minocycline - Placebo|||||
72509943|NCT05372575|144550707|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|0.74|||||TWO_SIDED|95.0|0.41|1.34|||||GMR=(GMC of VT+ Subgroup)/(GMC of VT- or Sp- Subgroup)|GMR of VT+ Subgroup/VT- or Sp- Subgroup in non-13vPnC Cohort for Serotype: 7F||1.34|0.41|
72480070|NCT01468831|144486436|OTHER|The difference between the minocycline and treatment arms in the number of participants experiencing a decrease in fluid leakage at Month 24 compared to baseline is reported.|Difference in Number of Participants|-1.0|||||TWO_SIDED||||||||Difference = Minocycline - Placebo|||||
72509944|NCT05372575|144550707|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|0.73|||||TWO_SIDED|95.0|0.34|1.57|||||GMR=(GMC of VT+ Subgroup)/(GMC of VT- or Sp- Subgroup)|GMR of VT+ Subgroup/VT- or Sp- Subgroup in non-13vPnC Cohort for Serotype: 9V||1.57|0.34|
72623712|NCT00023595|144778215|SUPERIORITY|||||||0.039||||||4 months|Chi-squared|H01 P-values were based on the Chi-Square test applied to maximum likelihood estimates derived from an adjusted mixed model.||||||0.039
72480071|NCT01468831|144486436|OTHER|The difference between the minocycline and treatment arms in the number of participants experiencing an increase in fluid leakage at Month 24 compared to baseline is reported.|Difference in Number of Participants|1.0|||||TWO_SIDED||||||||Difference = Minocycline - Placebo|||||
72480072|NCT01468831|144486436|OTHER|The difference between the minocycline and treatment arms in the number of participants experiencing no change in fluid leakage at Month 24 compared to baseline is reported.|Difference in Number of Participants|0.0|||||TWO_SIDED||||||||Difference = Minocycline - Placebo|||||
72480073|NCT00298090|144486441|SUPERIORITY_OR_OTHER||Other|0.0||||0.55|TWO_SIDED|95.0|-0.8|1.48|||repeated measures model||A repeated measures model was used to assess whether the one-minute average StO2 values differed systematically between pre and post arterial line placement.|||1.48|-0.80|0.55
72480074|NCT00887432|144486448|SUPERIORITY||Mean Difference (Net)|0.24||||0.431|TWO_SIDED|95.0|-0.36|0.84||Significance level of 0.05.|t-test, 2 sided|Paired t-test, df=86||Evaluated the change in PSA under the vitamin D and placebo conditions using the combined data (n=87).||0.84|-0.36|0.431
72480075|NCT00887432|144486449|SUPERIORITY|Comparing the mean PSA slopes between conditions (on vitamin D versus on placebo).|Mean Difference (Net)|-0.00019||||0.112|TWO_SIDED|95.0|-0.00042|0.000045||Significance level of 0.05.|Mixed Models Analysis|||||0.000045|-0.00042|0.112
72509945|NCT05372575|144550707|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|0.44|||||TWO_SIDED|95.0|0.16|1.18|||||GMR=(GMC of VT+ Subgroup)/(GMC of VT- or Sp- Subgroup)|GMR of VT+ Subgroup/VT- or Sp- Subgroup in non-13vPnC Cohort for Serotype: 14||1.18|0.16|
72509946|NCT05372575|144550707|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|0.59|||||TWO_SIDED|95.0|0.25|1.4|||||GMR=(GMC of VT+ Subgroup)/(GMC of VT- or Sp- Subgroup)|GMR of VT+ Subgroup/VT- or Sp- Subgroup in non-13vPnC Cohort for Serotype: 18C||1.40|0.25|
72509947|NCT05372575|144550707|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|0.79|||||TWO_SIDED|95.0|0.5|1.23|||||GMR=(GMC of VT+ Subgroup)/(GMC of VT- or Sp- Subgroup)|GMR of VT+ Subgroup/VT- or Sp- Subgroup in non-13vPnC Cohort for Serotype: 19A||1.23|0.50|
72623713|NCT00023595|144778215|SUPERIORITY|||||||0.002||||||12 months|Chi-squared|||||||0.002
72623714|NCT00023595|144778215|SUPERIORITY|||||||0.008||||||24 months|Chi-squared|||||||0.008
72623715|NCT00023595|144778215|SUPERIORITY|||||||0.31||||||36 months|Chi-squared|||||||0.31
72623716|NCT00023595|144778216|SUPERIORITY|||||||0.36||||||Baseline|Wilcoxon (Mann-Whitney)|||||||0.36
72623717|NCT00023595|144778216|SUPERIORITY|||||||0.87||||||4 months|Wilcoxon (Mann-Whitney)|||||||0.87
72623718|NCT00023595|144778216|SUPERIORITY|||||||0.17||||||12 months|Wilcoxon (Mann-Whitney)|||||||0.17
72480076|NCT00899548|144486451|SUPERIORITY||Hazard Ratio (HR)|1.76||||0.0002|TWO_SIDED|95.0|1.23|2.52|||Gehan|Distributions compared between using the Gehan test, which gives more weight to early differences.||||2.52|1.23|.0002
72480077|NCT00899548|144486452|OTHER||Cox Proportional Hazard|1.19||||0.001|TWO_SIDED|95.0|1.07|1.32|||Regression, Cox|||Hazard ratio||1.32|1.07|0.001
72480078|NCT00899548|144486455|SUPERIORITY||Hazard Ratio (HR)|1.7||||0.001|TWO_SIDED|95.0|1.18|2.45|||Gehan|Distributions compared between using the Gehan test, which gives more weight to early differences.||||2.45|1.18|.001
72480079|NCT05007808|144486482|SUPERIORITY|ANCOVA model with Change from Baseline to Week 4/EOT as the outcome (dependent) variable, treatment as the independent variable, and baseline score as covariate. The p-value was derived from the t-test for the comparison of adjusted LS means between the treatment groups.|LS Mean Difference|-0.19||||0.6742|TWO_SIDED|95.0|-1.081|0.701|||t-test, 2 sided|||||0.701|-1.081|0.6742
72480080|NCT01275131|144486514|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|13.95||||0.0009|TWO_SIDED|90.0|7.37|20.54|||Mixed Models Analysis|A mixed model with fixed effects for treatment, day, and interaction of treatment with day was performed using a compound symmetric covariance matrix.||Comparison at Stage 1, Day 2/6||20.54|7.37|0.0009
72480081|NCT01275131|144486514|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|18.14|||<|0.0001|TWO_SIDED|90.0|11.55|24.72|||Mixed Models Analysis|A mixed model with fixed effects for treatment, day, and interaction of treatment with day was performed using a compound symmetric covariance matrix.||Comparison at Stage 1, Day 4/8||24.72|11.55|<0.0001
72480082|NCT01275131|144486516|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|16.41|||<|0.0001|TWO_SIDED|90.0|11.86|20.97|||Mixed Models Analysis|Mixed model with fixed effects for treatment, day, and interaction of treatment with day. A compound symmetric covariance matrix was assumed.||Comparison at Stage 3, Day 2/7||20.97|11.86|<0.0001
72480083|NCT01275131|144486516|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|14.1|||<|0.0001|TWO_SIDED|90.0|9.55|18.65|||Mixed Models Analysis|Mixed model with fixed effects for treatment, day, and interaction of treatment with day. A compound symmetric covariance matrix was assumed.||Comparison at Stage 3, Day 3/8||18.65|9.55|<0.0001
72480084|NCT01275131|144486516|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|5.32||||0.0552|TWO_SIDED|90.0|0.77|9.88|||Mixed Models Analysis|Mixed model with fixed effects for treatment, day, and interaction of treatment with day. A compound symmetric covariance matrix was assumed.||Comparison at Stage 3, Day 5/10||9.88|0.77|0.0552
72509948|NCT05372575|144550707|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|1.14|||||TWO_SIDED|95.0|0.6|2.18|||||GMR=(GMC of VT+ Subgroup)/(GMC of VT- or Sp- Subgroup)|GMR of VT+ Subgroup/VT- or Sp- Subgroup in non-13vPnC Cohort for Serotype: 19F||2.18|0.60|
72400574|NCT00975481|144308993|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-31.1439|||<|0.0001|TWO_SIDED|95.0|-41.4754|-20.8124|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-20.8124|-41.4754|<0.0001
72480085|NCT00731120|144486528|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.87|STANDARD_ERROR_OF_MEAN|0.803||0.279|TWO_SIDED|95.0|-2.45|0.71||Hierarchical testing stopped at 10 mg versus placebo for HAM-A total score at Week 8 in the testing sequence, a nominal p-value is provided.|ANCOVA|Analysis of covariance (ANCOVA), with treatment and center as fixed factors and baseline HAM-A as a covariate.||P-values were tested at the 5% significance level (ie, statistical significance if P\<0.05). To control for multiplicity, a pre-specified sequential testing procedure was applied to compare 10 mg and 2.5 mg vortioxetine to placebo; as soon as an endpoint was non-significant at 0.05, the testing procedure stopped for all subsequent endpoints.||0.71|-2.45|0.279
72480086|NCT00731120|144486528|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.81|STANDARD_ERROR_OF_MEAN|0.791||0.306|TWO_SIDED|95.0|-2.36|0.74||Pre-specified sequential statistical testing procedure indicates that when p-value \>0.05, hierarchical testing stops and for subsequent endpoints in the sequence a nominal p-value is provided.|ANCOVA|Analysis of covariance (ANCOVA), with treatment and center as fixed factors and baseline HAM-A as a covariate.||||0.74|-2.36|0.306
72480087|NCT02411357|144486538|SUPERIORITY||||||<|0.001|||||||Cochran-Armitage Chi-square trend test|||||||<.001
72480088|NCT00529958|144486541|EQUIVALENCE|The sample size calculation was based on 88 ACL-deficient patients with surgical intervention and an ACL-QOL score of 74.5 (SD=20.1) at a mean 39-month follow-up, a minimal clinically important difference of 10 points, power=0.80 and p=0.05.|||||<|0.05||||||A Bonferroni adjustment for multiple comparisons was used in the sample size calculation, resulting in 90 patients per group. With a 20% lost-to-follow-up rate, the final sample size was 108 patients per group for a total of 324 patients.|Mixed Models Analysis|||"All patients were analyzed on an intention-to-treat basis using a 5% significance level for all analyses. The ACL-QOL scores for each study group were analyzed using adjusted Bonferroni comparisons and repeated-measures analyses, using a mixed-model analysis of variance for treatment group over time of assessment."||||<0.05
72480089|NCT03316300|144486554|SUPERIORITY||Mean Difference (Final Values)|-0.091|STANDARD_ERROR_OF_MEAN|0.0176|<|0.0001|TWO_SIDED|95.0|-0.13|-0.06|||Mixed Models Analysis|||||-0.06|-0.13|<0.0001
72480090|NCT00557947|144486557|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence is demonstrated if the upper limit of the 95% confidence interval (when subtracting the percentage of DERMABOND PROTAPE successful subjects from the percentage of INTRADERMAL SUTURE successful subjects) does not exceed 12%.|difference proportions of successes (%)|4.8||||0.2188|TWO_SIDED|95.0|0.0|10.9|||McNemar||The level of significance for statistical testing was 0.05 for this study.|||10.9|-0.0|0.2188
72480091|NCT00557947|144486558|SUPERIORITY_OR_OTHER||||||<|0.0001||0.0|||||t-test, 2 sided|||||||<0.0001
72480092|NCT00557947|144486559|SUPERIORITY_OR_OTHER|||||||0.3877||0.0|||||McNemar|||||||0.3877
72480093|NCT00557947|144486560|SUPERIORITY_OR_OTHER|||||||0.7539||0.0|||||McNemar|||||||0.7539
72480094|NCT00557947|144486561|SUPERIORITY_OR_OTHER|||||||1||0.0|||||McNemar|||||||1.0000
72480095|NCT03756129|144486562|SUPERIORITY||Median Difference (Net)|-8.25||||0.0013|TWO_SIDED|80.0|-11.67|-4.83|||ANCOVA|||"Comparison of adjusted arithmetic mean: Mean Difference: Pooled MIJ821 0.16 mg/kg minus placebo. The MIJ821 treatment arms vs placebo are primary."||-4.83|-11.67|0.0013
72400575|NCT00975481|144308994|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|24.8779|||<|0.0001|TWO_SIDED|95.0|19.5658|30.1899|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emax, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||30.1899|19.5658|<0.0001
72400576|NCT00975481|144308994|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|25.9857|||<|0.0001|TWO_SIDED|95.0|20.667|31.3043|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emax, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||31.3043|20.6670|<0.0001
72400577|NCT00975481|144308994|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.0544||||0.4489|TWO_SIDED|95.0|-3.2911|7.3998|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emax, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||7.3998|-3.2911|0.4489
72400578|NCT00975481|144308994|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.5743||||0.8329|TWO_SIDED|95.0|-4.7941|5.9427|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emax, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||5.9427|-4.7941|0.8329
72400579|NCT00975481|144308994|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.6863||||0.5387|TWO_SIDED|95.0|-3.7203|7.0929|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emax, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||7.0929|-3.7203|0.5387
72400580|NCT00975481|144308994|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-22.8235|||<|0.0001|TWO_SIDED|95.0|-28.1283|-17.5187|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emax, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-17.5187|-28.1283|<0.0001
72400581|NCT00975481|144308994|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-24.3036|||<|0.0001|TWO_SIDED|95.0|-29.64|-18.9672|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emax, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-18.9672|-29.6400|<0.0001
72480096|NCT03756129|144486562|SUPERIORITY||Mean Difference (Net)|-5.71||||0.0196|TWO_SIDED|80.0|-9.22|-2.2|||ANCOVA|||"Comparison of adjusted arithmetic mean: Mean Difference: Pooled MIJ821 0.32 mg/kg minus placebo. The MIJ821 treatment arms vs placebo are primary."||-2.20|-9.22|0.0196
72480097|NCT03756129|144486563|SUPERIORITY||Mean Difference (Net)|-7.06||||0.013|TWO_SIDED|80.0|-11.06|-3.06|||ANCOVA|||"Comparison of adjusted arithmetic mean: Mean Difference: Pooled MIJ821 0.16 mg/kg minus placebo."||-3.06|-11.06|0.0130
72480098|NCT03756129|144486563|SUPERIORITY||Median Difference (Net)|-7.37||||0.0133|TWO_SIDED|80.0|-11.57|-3.18|||ANCOVA|||"Comparison of adjusted arithmetic mean: Mean Difference: Pooled MIJ821 0.32 mg/kg minus placebo."||-3.18|-11.57|0.0133
72480099|NCT03756129|144486564|SUPERIORITY||Mean Difference (Net)|-5.09||||0.1082|TWO_SIDED|80.0|-10.37|0.19|||ANCOVA|||"Comparison of adjusted arithmetic mean: Mean Difference: MIJ821 0.16 mg/kg weekly minus placebo."||0.19|-10.37|0.1082
72480100|NCT03756129|144486564|SUPERIORITY||Mean Difference (Net)|-5.42||||0.0993|TWO_SIDED|80.0|-10.83|-0.02|||ANCOVA|||"Comparison of adjusted arithmetic mean: Mean Difference: MIJ821 0.32 mg/kg weekly minus placebo."||-0.02|-10.83|0.0993
72480101|NCT03756129|144486564|SUPERIORITY||Mean Difference (Net)|-6.46||||0.0598|TWO_SIDED|80.0|-11.78|-1.15|||ANCOVA|||"Comparison of adjusted arithmetic mean: Mean Difference: MIJ821 0.16 mg/kg biweekly minus placebo."||-1.15|-11.78|0.0598
72480102|NCT03756129|144486564|SUPERIORITY||Mean Difference (Net)|-3.06||||0.2491|TWO_SIDED|80.0|-8.86|2.74|||ANCOVA|||"Comparison of adjusted arithmetic mean: Mean Difference: MIJ821 0.32 mg/kg biweekly minus placebo."||2.74|-8.86|0.2491
72509949|NCT05372575|144550707|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|1.08|||||TWO_SIDED|95.0|0.68|1.72|||||GMR=(GMC of VT+ Subgroup)/(GMC of VT- or Sp- Subgroup)|GMR of VT+ Subgroup/VT- or Sp- Subgroup in non-13vPnC Cohort for Serotype: 23F||1.72|0.68|
72509950|NCT05372575|144550707|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|10.3|||||TWO_SIDED|95.0|2.44|43.49|||||GMR=(GMC of 13vPnC VT+ Subgroup)/(GMC of non-13vPnC VT+ Subgroup)|GMR of 13vPnC Cohort/non-13vPnC Cohort in VT+ Subgroups for Serotype: 1||43.49|2.44|
72509951|NCT05372575|144550707|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|6.17|||||TWO_SIDED|95.0|2.07|18.42|||||GMR=(GMC of 13vPnC VT+ Subgroup)/(GMC of non-13vPnC VT+ Subgroup)|GMR of 13vPnC Cohort/non-13vPnC Cohort in VT+ Subgroups for Serotype: 3||18.42|2.07|
72623719|NCT00023595|144778216|SUPERIORITY|||||||0.12||||||24 months|Wilcoxon (Mann-Whitney)|||||||0.12
72623720|NCT00023595|144778216|SUPERIORITY|||||||0.79||||||36 months|Wilcoxon (Mann-Whitney)|||||||0.79
72623721|NCT00023595|144778217|SUPERIORITY||||||<|0.001||||||4 months|Chi-squared|||||||<0.001
72623722|NCT00023595|144778217|SUPERIORITY||||||<|0.001||||||12 months|Chi-squared|||||||<0.001
72623723|NCT00023595|144778217|SUPERIORITY||||||<|0.001||||||24 months|Chi-squared|||||||<0.001
72623724|NCT00023595|144778217|SUPERIORITY||||||<|0.024||||||36 months|Chi-squared|||||||<0.024
72623725|NCT00023595|144778218|SUPERIORITY|||||||0.31||||||Baseline|Wilcoxon (Mann-Whitney)|||||||0.31
72623726|NCT00023595|144778218|SUPERIORITY|||||||0.42||||||4 months|Wilcoxon (Mann-Whitney)|||||||0.42
72623727|NCT00023595|144778218|SUPERIORITY|||||||0.66||||||12 months|Wilcoxon (Mann-Whitney)|||||||0.66
72623728|NCT00023595|144778218|SUPERIORITY|||||||0.32||||||24 months|Wilcoxon (Mann-Whitney)|||||||0.32
72623729|NCT00023595|144778218|SUPERIORITY|||||||0.43||||||36 months|Wilcoxon (Mann-Whitney)|||||||0.43
72623730|NCT00023595|144778219|SUPERIORITY|||||||0.051||||||4 months|Chi-squared|H01 P-values were based on the Chi-Square test applied to maximum likelihood estimates derived from an adjusted mixed model.||||||0.051
72623731|NCT00023595|144778219|SUPERIORITY|||||||0.003||||||12 months|Chi-squared|||||||0.003
72623732|NCT00023595|144778219|SUPERIORITY|||||||0.065||||||24 months|Chi-squared|||||||0.065
72623733|NCT00023595|144778219|SUPERIORITY|||||||0.83||||||36 months|Chi-squared|||||||0.83
72623734|NCT00023595|144778220|SUPERIORITY|||||||0.71||||||Baseline|Wilcoxon (Mann-Whitney)|||||||0.71
72623735|NCT00023595|144778220|SUPERIORITY|||||||0.57||||||4 months|Wilcoxon (Mann-Whitney)|||||||0.57
72623736|NCT00023595|144778220|SUPERIORITY|||||||0.15||||||12 months|Wilcoxon (Mann-Whitney)|||||||0.15
72623737|NCT00023595|144778220|SUPERIORITY|||||||0.64||||||24 months|Wilcoxon (Mann-Whitney)|||||||0.64
72623738|NCT00023595|144778220|SUPERIORITY|||||||0.07||||||36 months|Wilcoxon (Mann-Whitney)|||||||0.07
72623739|NCT00023595|144778221|SUPERIORITY|||||||0.004||||||4 months|Chi-squared|H01 P-values were based on the Chi-Square test applied to maximum likelihood estimates derived from an adjusted mixed model.||||||0.004
72623740|NCT00023595|144778221|SUPERIORITY|||||||0.011||||||12 months|Chi-squared|||||||0.011
72623741|NCT00023595|144778221|SUPERIORITY|||||||0.007||||||24 months|Chi-squared|||||||0.007
72623742|NCT00023595|144778221|SUPERIORITY|||||||0.044||||||36 months|Chi-squared|||||||0.044
72623743|NCT00023595|144778222|SUPERIORITY|||||||0.74||||||Baseline|Wilcoxon (Mann-Whitney)|||||||0.74
72623744|NCT00023595|144778222|SUPERIORITY|||||||0.87||||||4 months|Wilcoxon (Mann-Whitney)|||||||0.87
72623745|NCT00023595|144778222|SUPERIORITY|||||||0.03||||||12 months|Wilcoxon (Mann-Whitney)|||||||0.03
72623746|NCT00023595|144778222|SUPERIORITY|||||||0.6||||||24 months|Wilcoxon (Mann-Whitney)|||||||0.60
72623747|NCT00023595|144778222|SUPERIORITY|||||||0.87||||||36 months|Wilcoxon (Mann-Whitney)|||||||0.87
72623748|NCT00023595|144778223|SUPERIORITY|||||||0.05||||||4 months|Chi-squared|H01 P-values were based on the Chi-Square test applied to maximum likelihood estimates derived from an adjusted mixed model.||||||0.050
72623749|NCT00023595|144778223|SUPERIORITY|||||||0.003||||||12 months|Chi-squared|||||||0.003
72623750|NCT00023595|144778223|SUPERIORITY|24 months||||||0.049|||||||Chi-squared|||||||0.049
72623751|NCT00023595|144778223|SUPERIORITY|||||||0.097||||||36 months|Chi-squared|||||||0.097
72623752|NCT00023595|144778224|SUPERIORITY|||||||0.4||||||Baseline|Wilcoxon (Mann-Whitney)|||||||0.40
72623753|NCT00023595|144778224|SUPERIORITY|||||||0.13||||||4 months|Wilcoxon (Mann-Whitney)|||||||0.13
72623754|NCT00023595|144778224|SUPERIORITY|||||||0.86||||||12 months|Wilcoxon (Mann-Whitney)|||||||0.86
72623755|NCT00023595|144778224|SUPERIORITY|||||||0.89||||||24 months|Wilcoxon (Mann-Whitney)|||||||0.89
72623756|NCT00023595|144778224|SUPERIORITY|||||||0.87||||||36 months|Wilcoxon (Mann-Whitney)|||||||0.87
72623757|NCT00023595|144778225|SUPERIORITY|||||||0.005||||||4 months|Wilcoxon (Mann-Whitney)|||||||0.005
72623758|NCT00023595|144778225|SUPERIORITY|||||||0.023||||||12 months|Wilcoxon (Mann-Whitney)|||||||0.023
72623759|NCT00023595|144778225|SUPERIORITY|||||||0.009||||||24 months|Wilcoxon (Mann-Whitney)|||||||0.009
72623760|NCT00023595|144778225|SUPERIORITY|||||||0.26||||||36 months|Wilcoxon (Mann-Whitney)|||||||0.26
72623761|NCT00023595|144778226|SUPERIORITY|||||||0.38||||||Baseline|Wilcoxon (Mann-Whitney)|||||||0.38
72623762|NCT00023595|144778226|SUPERIORITY|||||||0.45||||||4 months|Wilcoxon (Mann-Whitney)|||||||0.45
72623763|NCT00023595|144778226|SUPERIORITY|||||||0.62||||||12 months|Wilcoxon (Mann-Whitney)|||||||0.62
72623764|NCT00023595|144778226|SUPERIORITY|||||||0.82||||||24 months|Wilcoxon (Mann-Whitney)|||||||0.82
72623765|NCT00023595|144778226|SUPERIORITY|||||||0.94||||||36 months|Wilcoxon (Mann-Whitney)|||||||0.94
72623766|NCT00023595|144778227|SUPERIORITY|||||||0.205||||||4 months|Chi-squared|H01 P-values were based on the Chi-Square test applied to maximum likelihood estimates derived from an adjusted mixed model.||||||0.205
72623767|NCT00023595|144778227|SUPERIORITY|||||||0.017||||||12 months|Chi-squared|||||||0.017
72623768|NCT00023595|144778227|SUPERIORITY|||||||0.028||||||24 months|Chi-squared|||||||0.028
72623769|NCT00023595|144778227|SUPERIORITY|||||||0.123||||||36 months|Chi-squared|||||||0.123
72623770|NCT00023595|144778228|SUPERIORITY|||||||0.19||||||Baseline|Wilcoxon (Mann-Whitney)|||||||0.19
72623771|NCT00023595|144778228|SUPERIORITY|||||||0.07||||||4 months|Wilcoxon (Mann-Whitney)|||||||0.07
72623772|NCT00023595|144778228|SUPERIORITY|||||||0.94||||||12 months|Wilcoxon (Mann-Whitney)|||||||0.94
72623773|NCT00023595|144778228|SUPERIORITY|||||||0.67||||||24 months|Wilcoxon (Mann-Whitney)|||||||0.67
72623774|NCT00023595|144778228|SUPERIORITY|||||||0.44||||||36 months|Wilcoxon (Mann-Whitney)|||||||0.44
72623775|NCT00023595|144778229|SUPERIORITY|||||||0.05||||||4 months|Chi-squared|P-values were based on the Chi-Square test applied to maximum likelihood estimates derived from an adjusted mixed model.||||||0.050
72623776|NCT00023595|144778229|SUPERIORITY|||||||0.006||||||12 months|Chi-squared|||||||0.006
72623777|NCT00023595|144778229|SUPERIORITY|||||||0.039||||||24 months|Chi-squared|||||||0.039
72623778|NCT00023595|144778229|SUPERIORITY|||||||0.074||||||36 months|Chi-squared|||||||0.074
72623779|NCT00023595|144778230|SUPERIORITY|||||||0.23||||||Baseline|Wilcoxon (Mann-Whitney)|||||||0.23
72480103|NCT01315353|144486581|SUPERIORITY|Confidence interval estimation was stratified by ART use at screening using Greenwood's variance with the inverse of this variance used for the stratum weights.|Cumulative rate difference|1.7|||||ONE_SIDED|95.0|-7.9||||||The lower bound of the (lower) one-sided 95% confidence interval was provided.|Treatment comparison was made using the difference (arm B - arm A) in the stratified Kaplan-Meier estimate for the week 130 cumulative rate of CIN2+ with 95% one-sided confidence interval.|||-7.9|
72480104|NCT01315353|144486582|OTHER|||||||0.94||||||The p-value is not adjusted for multiple comparisons. The a priori threshold for statistical significance used for the two-sided test was 0.05.|Log Rank|Log-rank test was stratified by ART use at screening.||Null Hypothesis: There is no difference between Arm A and Arm B with respect to time to CIN2+.||||0.94
72480105|NCT01315353|144486583|OTHER||Cumulative rate difference|4.4|||||TWO_SIDED|95.0|-4.8|13.6|||||Confidence interval estimation was stratified by ART use at screening using Greenwood's variance with the inverse of this variance used for the stratum weights.|Treatment comparison was made using the difference (arm B - arm A) in the stratified Kaplan-Meier estimate for the week 130 cumulative rate of CIN3+ with 95% two-sided confidence interval.||13.6|-4.8|
72480106|NCT01315353|144486584|OTHER|||||||0.445||||||The p-value is not adjusted for multiple comparisons. The a priori threshold for statistical significance used for the two-sided test was 0.05.|Fisher Exact|||Null hypothesis: There is no difference between Arm A and Arm B with respect to rate of premature study discontinuation.||||0.445
72480107|NCT01315353|144486585|OTHER|||||||1||||||P-value for the week 26 comparison. The p-value is not adjusted for multiple comparisons. The a priori threshold for statistical significance used for the two-sided test was 0.05.|Fisher Exact|||Null Hypothesis: There is no difference between Arm A and Arm B with respect to the proportion of participants with abnormal cervical cytology results at week 26.||||1.000
72509952|NCT05372575|144550707|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|18.7|||||TWO_SIDED|95.0|4.35|80.37|||||GMR=(GMC of 13vPnC VT+ Subgroup)/(GMC of non-13vPnC VT+ Subgroup)|GMR of 13vPnC Cohort/non-13vPnC Cohort in VT+ Subgroups for Serotype: 4||80.37|4.35|
72509953|NCT05372575|144550707|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|2.5|||||TWO_SIDED|95.0|1.14|5.52|||||GMR=(GMC of 13vPnC VT+ Subgroup)/(GMC of non-13vPnC VT+ Subgroup)|GMR of 13vPnC Cohort/non-13vPnC Cohort in VT+ Subgroups for Serotype: 5||5.52|1.14|
72509954|NCT05372575|144550707|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|5.24|||||TWO_SIDED|95.0|2.33|11.8|||||GMR=(GMC of 13vPnC VT+ Subgroup)/(GMC of non-13vPnC VT+ Subgroup)|GMR of 13vPnC Cohort/non-13vPnC Cohort in VT+ Subgroups for Serotype: 6A||11.80|2.33|
72509955|NCT05372575|144550707|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|3.77|||||TWO_SIDED|95.0|1.47|9.65|||||GMR=(GMC of 13vPnC VT+ Subgroup)/(GMC of non-13vPnC VT+ Subgroup)|GMR of 13vPnC Cohort/non-13vPnC Cohort in VT+ Subgroups for Serotype: 6B||9.65|1.47|
72623780|NCT00023595|144778230|SUPERIORITY|||||||0.43||||||4 months|Wilcoxon (Mann-Whitney)|||||||0.43
72480108|NCT01315353|144486585|OTHER|||||||0.279||||||"P-value for the week 52 comparison.~The p-value is not adjusted for multiple comparisons. The a priori threshold for statistical significance used for the two-sided test was 0.05."|Fisher Exact|||Null Hypothesis: There is no difference between the Arm A and Arm B with respect to the proportion of participants with abnormal cervical cytology results at week 52.||||0.279
72480109|NCT01315353|144486585|OTHER|||||||0.781||||||"P-value for the week 78 comparison.~The p-value is not adjusted for multiple comparisons. The a priori threshold for statistical significance used for the two-sided test was 0.05."|Fisher Exact|||Null Hypothesis: There is no difference between Arm A and Arm B with respect to the proportion of participants with abnormal cervical cytology results at week 78.||||0.781
72480110|NCT01315353|144486585|OTHER|||||||0.375||||||"P-value for the week 104 comparison.~The p-value is not adjusted for multiple comparisons. The a priori threshold for statistical significance used for the two-sided test was 0.05."|Fisher Exact|||Null Hypothesis: There is no difference between Arm A and Arm B with respect to the proportion of participants with abnormal cervical cytology results at week 104.||||0.375
72480111|NCT01315353|144486585|OTHER|||||||0.444||||||"P-value for the week 130 comparison.~The p-value is not adjusted for multiple comparisons. The a priori threshold for statistical significance used for the two-sided test was 0.05."|Fisher Exact|||Null Hypothesis: There is no difference between Arm A and Arm B with respect to the proportion of participants with abnormal cervical cytology results at week 130.||||0.444
72509956|NCT05372575|144550707|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|5.94|||||TWO_SIDED|95.0|1.65|21.36|||||GMR=(GMC of 13vPnC VT+ Subgroup)/(GMC of non-13vPnC VT+ Subgroup)|GMR of 13vPnC Cohort/non-13vPnC Cohort in VT+ Subgroups for Serotype: 7F||21.36|1.65|
72509957|NCT05372575|144550707|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|4.44|||||TWO_SIDED|95.0|1.17|16.87|||||GMR=(GMC of 13vPnC VT+ Subgroup)/(GMC of non-13vPnC VT+ Subgroup)|GMR of 13vPnC Cohort/non-13vPnC Cohort in VT+ Subgroups for Serotype: 9V||16.87|1.17|
72623781|NCT00023595|144778230|SUPERIORITY|||||||0.35||||||12 months|Wilcoxon (Mann-Whitney)|||||||0.35
72623782|NCT00023595|144778230|SUPERIORITY|||||||0.9||||||24 months|Wilcoxon (Mann-Whitney)|||||||0.90
72623783|NCT00023595|144778230|SUPERIORITY|||||||0.48||||||36 months|Wilcoxon (Mann-Whitney)|||||||0.48
72480112|NCT01315353|144486586|OTHER|||||||0.132||||||"P-value for the week 26 comparison.~The p-value is not adjusted for multiple comparisons. The a priori threshold for statistical significance used for the two-sided test was 0.05."|Fisher Exact|||Null Hypothesis: There is no difference between Arm A and Arm B with respect to the proportion of participants with hr-HPV at week 26.||||0.132
72480113|NCT01315353|144486587|OTHER|||||||0.227||||||"P-value for the week 26 comparison.~The p-value is not adjusted for multiple comparisons. The a priori threshold for statistical significance used for the two-sided test was 0.05."|Fisher Exact|||Null Hypothesis: There is no difference between Arm A and Arm B with respect to the proportion of participants with hr-HPV at week 26.||||0.227
72480114|NCT01315353|144486588|OTHER|||||||1||||||"P-value for the week 26 comparison.~The p-value is not adjusted for multiple comparisons. The a priori threshold for statistical significance used for the two-sided test was 0.05."|Fisher Exact|||Null Hypothesis: There is no difference between Arm A and Arm B with respect to the proportion of participants with hr-HPV at week 26.||||1.000
72480115|NCT03567434|144486591|SUPERIORITY|The original hypothesis was that resting MSNA burst frequency would be higher the morning after evening binge alcohol when compared to fluid control condition. A p-value of \< 0.05 was used for significance.||||||0.283||||||The original hypothesis was that resting MSNA burst frequency would be higher the morning after evening binge alcohol when compared to fluid control condition. A p-value of \< 0.05 was used for significance.|t-test, 2 sided|||Statistical analysis on Burst Frequency (Burst/Min)||||0.283
72480116|NCT03567434|144486591|SUPERIORITY|The original hypothesis was that resting MSNA burst incidence would be higher the morning after evening binge alcohol when compared to fluid control condition. A p-value of \< 0.05 was used for significance.||||||0.92||||||The original hypothesis was that resting MSNA burst frequency would be higher the morning after evening binge alcohol when compared to fluid control condition. A p-value of \< 0.05 was used for significance.|t-test, 2 sided|||Statistical analysis on Burst Incidence (Burst/100hb)||||0.920
72480117|NCT03567434|144486593|SUPERIORITY|The original hypothesis was that sympathetic baroreflex sensitivity would be blunted the morning after evening binge alcohol when compared to fluid control condition. A p-value of \< 0.05 was used for significance.||||||0.888||||||The original hypothesis was that sympathetic baroreflex sensitivity would be blunted the morning after evening binge alcohol when compared to fluid control condition. A p-value of \< 0.05 was used for significance.|t-test, 2 sided|||||||0.888
72509958|NCT05372575|144550707|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|90.8|||||TWO_SIDED|95.0|16.67|494.56|||||GMR=(GMC of 13vPnC VT+ Subgroup)/(GMC of non-13vPnC VT+ Subgroup)|GMR of 13vPnC Cohort/non-13vPnC Cohort in VT+ Subgroups for Serotype: 14||494.56|16.67|
72509959|NCT05372575|144550707|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|17.83|||||TWO_SIDED|95.0|3.79|83.78|||||GMR=(GMC of 13vPnC VT+ Subgroup)/(GMC of non-13vPnC VT+ Subgroup)|GMR of 13vPnC Cohort/non-13vPnC Cohort in VT+ Subgroups for Serotype: 18C||83.78|3.79|
72480118|NCT03035201|144486597|OTHER|two-tailed test of the null hypothesis of no differences between groups.|Mean from linear contrast|0.03|STANDARD_ERROR_OF_MEAN|0.02|<|0.05|TWO_SIDED|95.0|-0.02|0.08||Not adjusted|Mixed Models Analysis||Marginal effect of cocoa flavonal versus cocoa placebo based on the mean difference between linear contrasts.|Marginal comparisons from a repeated measures model using a linear contrast to estimate the mean differences between baseline versus average values across follow-up.|Wald test of a linear contrast from the mixed effects analysis....see protocol.|0.08|-0.02|<0.05
72480119|NCT03035201|144486598|EQUIVALENCE|two-tailed test of the null hypothesis of no differences between groups.|Mean difference of linear contrasts|0.07|STANDARD_ERROR_OF_MEAN|0.02|<|0.05|TWO_SIDED|95.0|0.02|0.12||Not adjusted|Wald test||Marginal effects of multivitamin versus multivitamin placebo|Marginal comparisons from a repeated measures model using a linear contrast to estimate the mean differences between baseline versus average values across follow-up.|Wald test of a linear contrast from the mixed effects analysis....see protocol|0.12|0.02|<0.05
72480120|NCT03035201|144486599|EQUIVALENCE|Proportional hazards regression -- unadjusted two-sided test|Hazard Ratio (HR)|0.76||||0.15|TWO_SIDED|95.0|0.52|1.11||Not adjusted|Regression, Cox||Comparison group is placebo|||1.11|0.52|0.15
72480121|NCT03035201|144486600|EQUIVALENCE|Unadjusted 2-sided test|Cox Proportional Hazard|0.91||||0.62|TWO_SIDED|95.0|0.63|1.32||Unadjusted|Regression, Cox||Comparison group is placebo.|||1.32|0.63|0.62
72480122|NCT03035201|144486601|EQUIVALENCE|Cocoa Flavonal minus Placebo|Mean Difference (Net)|0.03|STANDARD_ERROR_OF_MEAN|0.03||0.24|TWO_SIDED|95.0|-0.02|0.08||Unadjusted|Mixed Models Analysis|Wald test comparing linear contrasts|Cocoa Flavonal minus placebo|||0.08|-0.02|0.24
72509960|NCT05372575|144550707|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|8.11|||||TWO_SIDED|95.0|3.6|18.3|||||GMR=(GMC of 13vPnC VT+ Subgroup)/(GMC of non-13vPnC VT+ Subgroup)|GMR of 13vPnC Cohort/non-13vPnC Cohort in VT+ Subgroups for Serotype: 19A||18.30|3.60|
72509961|NCT05372575|144550707|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|15.29|||||TWO_SIDED|95.0|4.64|50.35|||||GMR=(GMC of 13vPnC VT+ Subgroup)/(GMC of non-13vPnC VT+ Subgroup)|GMR of 13vPnC Cohort/non-13vPnC Cohort in VT+ Subgroups for Serotype: 19F||50.35|4.64|
72623784|NCT00023595|144778231|SUPERIORITY|||||||0.085||||||4 months|Chi-squared|H01 P-values were based on the Chi-Square test applied to maximum likelihood estimates derived from an adjusted mixed model.||||||0.085
72623785|NCT00023595|144778231|SUPERIORITY|||||||0.007|||||||Chi-squared|||||||0.007
72623786|NCT00023595|144778231|SUPERIORITY|||||||0.026||||||24 months|Chi-squared|||||||0.026
72623787|NCT00023595|144778231|SUPERIORITY|||||||0.085||||||36 months|Chi-squared|||||||0.085
72623788|NCT00023595|144778232|SUPERIORITY|||||||0.18||||||Baseline|Wilcoxon (Mann-Whitney)|||||||0.18
72623789|NCT00023595|144778232|SUPERIORITY|||||||0.17||||||4 months|Wilcoxon (Mann-Whitney)|||||||0.17
72400582|NCT00975481|144308994|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-23.1916|||<|0.0001|TWO_SIDED|95.0|-28.5768|-17.8064|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emax, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-17.8064|-28.5768|<0.0001
72400583|NCT00975481|144308994|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-23.9313|||<|0.0001|TWO_SIDED|95.0|-29.1559|-18.7066|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emax, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-18.7066|-29.1559|<0.0001
72400584|NCT00975481|144308994|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-25.4114|||<|0.0001|TWO_SIDED|95.0|-30.6869|-20.1358|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emax, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-20.1358|-30.6869|<0.0001
72400585|NCT00975481|144308994|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-24.2994|||<|0.0001|TWO_SIDED|95.0|-29.6361|-18.9626|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emax, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-18.9626|-29.6361|<0.0001
72400586|NCT00975481|144308994|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.4301||||0.5349|TWO_SIDED|95.0|-5.9725|3.1123|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emin, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||3.1123|-5.9725|0.5349
72400587|NCT00975481|144308994|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.1367||||0.0001|TWO_SIDED|95.0|-13.6684|-4.605|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emin, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-4.6050|-13.6684|0.0001
72400588|NCT00975481|144308994|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.3357||||0.5637|TWO_SIDED|95.0|-3.2244|5.8958|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emin, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||5.8958|-3.2244|0.5637
72400589|NCT00975481|144308994|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.4065||||0.8612|TWO_SIDED|95.0|-4.1779|4.9909|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emin, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||4.9909|-4.1779|0.8612
72400590|NCT00975481|144308994|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.9175||||0.6954|TWO_SIDED|95.0|-3.7022|5.5373|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emin, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||5.5373|-3.7022|0.6954
72480123|NCT03035201|144486602|EQUIVALENCE|two-sided|Median Difference (Final Values)|0.03|STANDARD_ERROR_OF_MEAN|0.03||0.41|TWO_SIDED|95.0|-0.04|0.09||Unadjusted|Mixed Models Analysis|Comparison of linear contrasts: cocoa flavonal minus placebo|Cocoa flavonal minus placebo|Unadjusted 2-tailed test||0.09|-0.04|0.41
72480124|NCT03035201|144486603|EQUIVALENCE|2 sided test, multivitamin minus placebo|Mean Difference (Net)|0.06|STANDARD_ERROR_OF_MEAN|0.03||0.02|TWO_SIDED|95.0|0.01|0.11||Unadjusted|Mixed Models Analysis|Comparison of linear contrasts|Multivitamin minus placebo|2-sided test, unadjusted||0.11|0.01|0.02
72480125|NCT03035201|144486604|EQUIVALENCE|2-sided, unadjusted|Mean Difference (Net)|0.06|STANDARD_ERROR_OF_MEAN|0.03||0.04|TWO_SIDED|95.0|0.002|0.126||Unadjusted|Mixed Models Analysis|Comparison of linear contrasts|Multivitamin minus placebo|Multivitamin minus placebo||0.126|0.002|0.04
72480126|NCT01880528|144486623|SUPERIORITY|||||||0.006|||||||Kruskal-Wallis|||||||0.006
72480127|NCT01880528|144486624|SUPERIORITY|||||||0.0337|||||||Kruskal-Wallis|||||||0.0337
72480128|NCT01880528|144486625|SUPERIORITY|||||||0.0427|||||||Kruskal-Wallis|||||||0.0427
72480129|NCT01880528|144486626|SUPERIORITY|||||||0.0237|||||||Kruskal-Wallis|||||||0.0237
72480130|NCT01439360|144486627|SUPERIORITY_OR_OTHER||Vaccine efficacy (VE)|63.2|||||TWO_SIDED|97.5|51.8|72.3|||Regression, Cox|Adjusted for age category and stratified for cohort.|VE was defined as the hazard ratio of cases of influenza A and or B disease in subjects receiving D-QIV vaccine in contrast with subjects receiving non-influenza vaccine control subtracted from 1.|The efficacy of the D-QIV vaccine would be demonstrated if the LL of the two-sided 97.5% CI for vaccine efficacy (VE) is above (\>) 25%.||72.3|51.8|
72623790|NCT00023595|144778232|SUPERIORITY|||||||0.59||||||12 months|Wilcoxon (Mann-Whitney)|||||||0.59
72623791|NCT00023595|144778232|SUPERIORITY|||||||0.78||||||24 months|Wilcoxon (Mann-Whitney)|||||||0.78
72623792|NCT00023595|144778232|SUPERIORITY|||||||0.48||||||36 months|Wilcoxon (Mann-Whitney)|||||||0.48
72480131|NCT01439360|144486628|SUPERIORITY_OR_OTHER||Vaccine efficacy (VE)|49.8|||||TWO_SIDED|97.5|41.8|56.8|||Regression, Cox|Adjusted for age category and stratified for cohort|VE was defined as the hazard ratio of cases of influenza A and or B disease in subjects receiving D-QIV vaccine in contrast with subjects receiving non-influenza vaccine control subtracted from 1.|The efficacy of the D-QIV vaccine would be demonstrated if the LL of the two-sided 97.5% CI for VE is above 15%.||56.8|41.8|
72509962|NCT05372575|144550707|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|4.19|||||TWO_SIDED|95.0|1.72|10.25|||||GMR=(GMC of 13vPnC VT+ Subgroup)/(GMC of non-13vPnC VT+ Subgroup)|GMR of 13vPnC Cohort/non-13vPnC Cohort in VT+ Subgroups for Serotype: 23F||10.25|1.72|
72480132|NCT03727438|144486668|EQUIVALENCE|alpha = .05|Mean Difference (Final Values)|-3.7|||<|0.01|TWO_SIDED|95.0|-5.0|-2.4||alpha=.05|Mixed Models Analysis|Model parameters included a common intercept (baseline means constrained to be equal), stratification variables, timepoint, and arm by timepoint.||"Analyses were conducted according to the intention-to-treat principle. All available data, including observations from participants who dropped out of the study, were used for primary and secondary analyses. Our modeling estimation approach was conducted with full-likelihood methods, providing unbiased treatment effect estimates under a missing-data framework known as missing at random (MAR)."||-2.4|-5.0|<0.01
72480133|NCT03727438|144486669|EQUIVALENCE|alpha= .05|Mean Difference (Final Values)|-19.6|||<|0.01|TWO_SIDED|95.0|-26.7|-12.5||alpha = 0.05|Mixed Models Analysis|||||-12.5|-26.7|<0.01
72480134|NCT03727438|144486670|EQUIVALENCE|alpha = .05|Mean Difference (Final Values)|-20.6|||<|0.01|TWO_SIDED|95.0|-29.1|-12.0||alpha = .05|Mixed Models Analysis|||||-12.0|-29.1|<0.01
72480135|NCT03727438|144486671|EQUIVALENCE|alpha = .05|Mean Difference (Final Values)|11.0|||<|0.01|TWO_SIDED|95.0|7.7|14.3|||Mixed Models Analysis|alpha = 0.05||||14.3|7.7|<0.01
72480136|NCT03727438|144486672|EQUIVALENCE|Alpha = .05|Mean Difference (Final Values)|-6.2|||>|0.05|TWO_SIDED|95.0|-12.5|0.1||Alpha = .05|Mixed Models Analysis|||||0.1|-12.5|> 0.05
72480137|NCT03727438|144486673|EQUIVALENCE|alpha = .05|Mean Difference (Final Values)|0.0|||>|0.05|TWO_SIDED|95.0|-0.4|0.5||alpha =.05|Mixed Models Analysis|||||.5|-.4|>0.05
72480138|NCT03727438|144486674|EQUIVALENCE|alpha = .05|Mean Difference (Final Values)|1.5|||<|0.05|TWO_SIDED|95.0|0.2|2.9||alpha = .05|Mixed Models Analysis|||||2.9|0.2|<0.05
72480139|NCT01912456|144486675|OTHER||||||<|0.001|||||||Mixed Models Analysis|||||||< 0.001
72480140|NCT01912456|144486675|OTHER||||||<|0.001|||||||Mixed Models Analysis|||||||< 0.001
72480141|NCT01912456|144486675|OTHER||||||=|0.114|||||||Mixed Models Analysis|||||||= 0.114
72480142|NCT01912456|144486676|OTHER||difference in percentages of responder|13.8|||||TWO_SIDED|95.0|-2.8|29.7||||||||29.7|-2.8|
72480143|NCT01912456|144486677|OTHER||||||<|0.001|||||||Mixed Models Analysis|||||||< 0.001
72480144|NCT01912456|144486677|OTHER||||||=|0.018|||||||Mixed Models Analysis|||||||= 0.018
72480145|NCT01912456|144486677|OTHER||||||=|0.31|||||||Mixed Models Analysis|||||||= 0.31
72480146|NCT01440374|144486692|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.202||||0.0315|TWO_SIDED|95.0|0.047|0.868|||Generalized Linear Mixed Models|||||0.868|0.047|0.0315
72623793|NCT00023595|144778233|SUPERIORITY||||||<|0.001||||||4 months|Chi-squared|H01 P-values were based on the Chi-Square test applied to maximum likelihood estimates derived from an adjusted mixed model.||||||<0.001
72480147|NCT00231153|144486710|SUPERIORITY_OR_OTHER||Net percentage difference|2.25||||0.082||95.0|-0.3|4.81||The primary null hypothesis was tested using the CMH chi-square test stratified region: North America or Europe. Alpha for this test will be 0.05, tow-tailed. No adjustment for multiplicity was performed.|Cochran-Mantel-Haenszel|||Adequate power was provided to test the null hypothesis that there would be no difference between treatment groups for LCSI. Overall LCSI rate was assumed to be approx. 7.5%, with reduction of LCSI by 40% with omiganan. LCSI rates in placebo and omiganan groups would be 9.375% and 5.625%. Sample size of 1548 in MITT set would provide 80% power to detect this difference between treatments. Sample size was also increased by 19% to account for deaths, for total of 1850 planned patients.||4.81|-0.30|0.082
72480148|NCT00231153|144486711|SUPERIORITY_OR_OTHER||Net percentage difference|3.67||||0.002||95.0|1.4|5.93|||Cochran-Mantel-Haenszel|||||5.93|1.40|0.002
72480149|NCT00231153|144486712|SUPERIORITY_OR_OTHER||Net percentage difference|11.4|||<|0.001||95.0|6.7|16.11|||Cochran-Mantel-Haenszel|||||16.11|6.70|<0.001
72480150|NCT04487834|144486713|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||||||<0.0001
72480151|NCT04487834|144486714|SUPERIORITY|||||||0.0001|||||||Fisher Exact|||||||0.0001
72480152|NCT04487834|144486715|SUPERIORITY|||||||0.4852|||||||Fisher Exact|||||||0.4852
72480153|NCT02647320|144486722|OTHER||LS Mean Difference|0.05|STANDARD_ERROR_OF_MEAN|0.157||0.755|TWO_SIDED|90.0|-0.211|0.309|||Mixed Model Repeated Measure|||Difference in change at week 12||0.309|-0.211|.755
72480154|NCT02647320|144486722|OTHER||LS Mean Difference|0.11|STANDARD_ERROR_OF_MEAN|0.161||0.512|TWO_SIDED|90.0|-0.16|0.371|||Mixed Model Repeated Measure|||Difference in change at week 12||0.371|-0.160|.512
72480155|NCT02647320|144486722|OTHER||LS Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.14||0.566|TWO_SIDED|90.0|-0.312|0.151|||Mixed Model Repeated Measure|||Difference in change at week 12||0.151|-0.312|.566
72480156|NCT02647320|144486722|OTHER||LS Mean Difference|-0.43|STANDARD_ERROR_OF_MEAN|0.139||0.002|TWO_SIDED|90.0|-0.655|-0.197|||Mixed Model Repeated Measure|||Difference in change at week 12||-0.197|-0.655|.002
72480157|NCT02647320|144486723|OTHER||LS Mean Difference|-4.6|STANDARD_ERROR_OF_MEAN|3.13||0.144|TWO_SIDED|90.0|-9.76|0.58|||Mixed Model Repeated Measure|||Difference in change at week 12||0.58|-9.76|.144
72480158|NCT02647320|144486723|OTHER||LS Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|3.16||0.773|TWO_SIDED|90.0|-6.14|4.31|||Mixed Model Repeated Measure|||Difference in change at week 12||4.31|-6.14|.773
72480159|NCT02647320|144486723|OTHER||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|2.79||0.963|TWO_SIDED|90.0|-4.73|4.48|||Mixed Model Repeated Measure|||Difference in change at week 12||4.48|-4.73|.963
72480160|NCT02647320|144486723|OTHER||LS Mean Difference|-3.1|STANDARD_ERROR_OF_MEAN|2.74||0.258|TWO_SIDED|90.0|-7.64|1.42|||Mixed Model Repeated Measure|||Difference in change at week 12||1.42|-7.64|.258
72480161|NCT02647320|144486724|OTHER||LS Mean Difference|-6.7|STANDARD_ERROR_OF_MEAN|5.5||0.228|TWO_SIDED|90.0|-15.74|2.43|||Mixed Model Repeated Measure|||Difference in change at week 12||2.43|-15.74|.228
72623794|NCT00023595|144778233|SUPERIORITY||||||<|0.001||||||12 month|Chi-squared|||||||<0.001
72623795|NCT00023595|144778233|SUPERIORITY||||||<|0.001||||||24 months|Chi-squared|||||||<0.001
72480162|NCT02647320|144486724|OTHER||LS Mean Difference|0.7|STANDARD_ERROR_OF_MEAN|5.51||0.894|TWO_SIDED|90.0|-8.36|9.84|||Mixed Model Repeated Measure|||Difference in change at week 12||9.84|-8.36|.894
72480163|NCT02647320|144486724|OTHER||LS Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|4.86||0.846|TWO_SIDED|90.0|-8.97|7.08|||Mixed Model Repeated Measure|||Difference in change at week 12||7.08|-8.97|.846
72480164|NCT02647320|144486724|OTHER||LS Mean Difference|-3.9|STANDARD_ERROR_OF_MEAN|4.77||0.409|TWO_SIDED|90.0|-11.82|3.93|||Mixed Model Repeated Measure|||Difference in change at week 12||3.93|-11.82|.409
72480165|NCT02647320|144486725|OTHER||LS Mean Difference|1.5|STANDARD_ERROR_OF_MEAN|2.59||0.576|TWO_SIDED|90.0|-2.83|5.73|||Mixed Model Repeated Measure|||Difference in change at week 12||5.73|-2.83|.576
72480166|NCT02647320|144486725|OTHER||LS Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|2.62||0.646|TWO_SIDED|90.0|-5.53|3.12|||Mixed Model Repeated Measure|||Difference in change at week 12||3.12|-5.53|.646
72480167|NCT02647320|144486725|OTHER||LS Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|2.3||0.902|TWO_SIDED|90.0|-3.52|4.08|||Mixed Model Repeated Measure|||Difference in change at week 12||4.08|-3.52|.902
72480168|NCT02647320|144486725|OTHER||LS Mean Difference|-1.6|STANDARD_ERROR_OF_MEAN|2.27||0.478|TWO_SIDED|90.0|-5.35|2.13|||Mixed Model Repeated Measure|||Difference in change at week 12||2.13|-5.35|.478
72509963|NCT05372575|144550707|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|13.93|||||TWO_SIDED|95.0|9.14|21.23|||||GMR=(GMC of 13vPnC VT- or Sp- Subgroup)/(GMC of non-13vPnC VT- or Sp- Subgroup)|GMR of 13vPnC Cohort/non-13vPnC Cohort in VT- or Sp- Subgroups for Serotype: 1||21.23|9.14|
72480169|NCT02647320|144486726|OTHER||LS Mean Difference|-7.6|STANDARD_ERROR_OF_MEAN|4.22||0.072|TWO_SIDED|90.0|-14.57|-0.64|||Mixed Model Repeated Measure|||Difference in change at week 12||-0.64|-14.57|.072
72480170|NCT02647320|144486726|OTHER||LS Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|4.26||0.794|TWO_SIDED|90.0|-8.15|5.92|||Mixed Model Repeated Measure|||Difference in change at week 12||5.92|-8.15|.794
72480171|NCT02647320|144486726|OTHER||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|3.75||0.946|TWO_SIDED|90.0|-6.45|5.94|||Mixed Model Repeated Measure|||Difference in change at week 12||5.94|-6.45|.946
72480172|NCT02647320|144486726|OTHER||LS Mean Difference|-2.9|STANDARD_ERROR_OF_MEAN|3.68||0.431|TWO_SIDED|90.0|-8.99|3.18|||Mixed Model Repeated Measure|||Difference in change at week 12||3.18|-8.99|.431
72480173|NCT02647320|144486727|OTHER||LS Mean Difference|-10.3|STANDARD_ERROR_OF_MEAN|8.54||0.228|TWO_SIDED|90.0|-24.43|3.78|||Mixed Model Repeated Measure|||Difference in change at week 12||3.78|-24.43|.228
72480174|NCT02647320|144486727|OTHER||LS Mean Difference|0.5|STANDARD_ERROR_OF_MEAN|8.62||0.951|TWO_SIDED|90.0|-13.7|14.77|||Mixed Model Repeated Measure|||Difference in change at week 12||14.77|-13.70|.951
72480175|NCT02647320|144486727|OTHER||LS Mean Difference|-1.4|STANDARD_ERROR_OF_MEAN|7.59||0.852|TWO_SIDED|90.0|-13.96|11.13|||Mixed Model Repeated Measure|||Difference in change at week 12||11.13|-13.96|.852
72480176|NCT02647320|144486727|OTHER||LS Mean Difference|-3.8|STANDARD_ERROR_OF_MEAN|7.45||0.608|TWO_SIDED|90.0|-16.13|8.48|||Mixed Model Repeated Measure|||Difference in change at week 12||8.48|-16.13|.608
72480177|NCT02647320|144486728|OTHER||LS Mean Difference|5.32|STANDARD_ERROR_OF_MEAN|15.289||0.728|TWO_SIDED|90.0|-19.932|30.566|||Mixed Model Repeated Measure|||Difference in change at week 4||30.566|-19.932|.728
72480178|NCT02647320|144486728|OTHER||LS Mean Difference|-3.27|STANDARD_ERROR_OF_MEAN|15.853||0.837|TWO_SIDED|90.0|-29.446|22.914|||Mixed Model Repeated Measure|||Difference in change at week 4||22.914|-29.446|.837
72480179|NCT02647320|144486728|OTHER||LS Mean Difference|-3.65|STANDARD_ERROR_OF_MEAN|13.747||0.791|TWO_SIDED|90.0|-26.352|19.051|||Mixed Model Repeated Measure|||Difference in change at week 4||19.051|-26.352|.791
72480180|NCT02647320|144486728|OTHER||LS Mean Difference|-40.03|STANDARD_ERROR_OF_MEAN|13.472||0.003|TWO_SIDED|90.0|-62.283|-17.787|||Mixed Model Repeated Measure|||Difference in change at week 4||-17.787|-62.283|.003
72480181|NCT02647320|144486729|OTHER||LS Mean Difference|4.39|STANDARD_ERROR_OF_MEAN|20.396||0.83|TWO_SIDED|90.0|-29.312|38.087|||Mixed Model Repeated Measure|||Difference in change at week 12||38.087|-29.312|.830
72480182|NCT02647320|144486729|OTHER||LS Mean Difference|24.25|STANDARD_ERROR_OF_MEAN|20.335||0.235|TWO_SIDED|90.0|-9.354|57.848|||Mixed Model Repeated Measure|||Difference in change at week 12||57.848|-9.354|.235
72480183|NCT02647320|144486729|OTHER||LS Mean Difference|17.25|STANDARD_ERROR_OF_MEAN|17.72||0.331|TWO_SIDED|90.0|-12.03|46.529|||Mixed Model Repeated Measure|||Difference in change at week 12||46.529|-12.030|.331
72480184|NCT02647320|144486729|OTHER||LS Mean Difference|-29.51|STANDARD_ERROR_OF_MEAN|17.393||0.091|TWO_SIDED|90.0|-58.254|-0.775|||Mixed Model Repeated Measure|||Difference in change at week 12||-0.775|-58.254|.091
72509964|NCT05372575|144550707|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|5.86|||||TWO_SIDED|95.0|4.17|8.24|||||GMR=(GMC of 13vPnC VT- or Sp- Subgroup)/(GMC of non-13vPnC VT- or Sp- Subgroup)|GMR of 13vPnC Cohort/non-13vPnC Cohort in VT- or Sp- Subgroups for Serotype: 3||8.24|4.17|
72623796|NCT00023595|144778233|SUPERIORITY|||||||0.018||||||36 months|Chi-squared|||||||0.018
72623797|NCT00023595|144778234|SUPERIORITY|||||||0.7||||||Baseline|Wilcoxon (Mann-Whitney)|||||||0.70
72623798|NCT00023595|144778234|SUPERIORITY|||||||0.47||||||4 months|Wilcoxon (Mann-Whitney)|||||||0.47
72623799|NCT00023595|144778234|SUPERIORITY|||||||0.87||||||12 months|Wilcoxon (Mann-Whitney)|||||||0.87
72623800|NCT00023595|144778234|SUPERIORITY|||||||0.84||||||24 months|Wilcoxon (Mann-Whitney)|||||||0.84
72623801|NCT00023595|144778234|SUPERIORITY|||||||0.82||||||36 months|Wilcoxon (Mann-Whitney)|||||||0.82
72623802|NCT00023595|144778235|SUPERIORITY|||||||0.023||||||4 months|Chi-squared|H01 P-values were based on the Chi-Square test applied to maximum likelihood estimates derived from an adjusted mixed model.||||||0.023
72623803|NCT00023595|144778235|SUPERIORITY|||||||0.001||||||12 months|Chi-squared|||||||0.001
72480185|NCT02647320|144486730|OTHER||LS Mean Difference|1.49|STANDARD_ERROR_OF_MEAN|9.28||0.873|TWO_SIDED|90.0|-13.835|16.815|||Mixed Model Repeated Measure|||Difference in change at week 4||16.815|-13.835|.873
72480186|NCT02647320|144486730|OTHER||LS Mean Difference|-8.09|STANDARD_ERROR_OF_MEAN|9.505||0.395|TWO_SIDED|90.0|-23.79|7.604|||Mixed Model Repeated Measure|||Difference in change at week 4||7.604|-23.790|.395
72480187|NCT02647320|144486730|OTHER||LS Mean Difference|-2.53|STANDARD_ERROR_OF_MEAN|8.306||0.761|TWO_SIDED|90.0|-16.247|11.185|||Mixed Model Repeated Measure|||Difference in change at week 4||11.185|-16.247|.761
72480188|NCT02647320|144486730|OTHER||LS Mean Difference|-27.73|STANDARD_ERROR_OF_MEAN|8.17|<|0.001|TWO_SIDED|90.0|-41.22|-14.236|||Mixed Model Repeated Measure|||Difference in change at week 4||-14.236|-41.220|<0.001
72480189|NCT02647320|144486731|OTHER||LS Mean Difference|-7.61|STANDARD_ERROR_OF_MEAN|12.001||0.527|TWO_SIDED|90.0|-27.441|12.221|||Mixed Model Repeated Measure|||Difference in change at week 12||12.221|-27.441|.527
72480190|NCT02647320|144486731|OTHER||LS Mean Difference|-7.39|STANDARD_ERROR_OF_MEAN|0.532||0.532|TWO_SIDED|90.0|-26.927|12.138|||Mixed Model Repeated Measure|||Difference in change at week 12||12.138|-26.927|.532
72509965|NCT05372575|144550707|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|19.97|||||TWO_SIDED|95.0|12.8|31.15|||||GMR=(GMC of 13vPnC VT- or Sp- Subgroup)/(GMC of non-13vPnC VT- or Sp- Subgroup)|GMR of 13vPnC Cohort/non-13vPnC Cohort in VT- or Sp- Subgroups for Serotype: 4||31.15|12.80|
72480191|NCT02647320|144486731|OTHER||LS Mean Difference|-4.41|STANDARD_ERROR_OF_MEAN|10.421||0.672|TWO_SIDED|90.0|-21.635|12.807|||Mixed Model Repeated Measure|||Difference in change at week 12||12.807|-21.635|.672
72480192|NCT02647320|144486731|OTHER||LS Mean Difference|-31.58|STANDARD_ERROR_OF_MEAN|10.229||0.002|TWO_SIDED|90.0|-48.482|-14.676|||Mixed Model Repeated Measure|||Difference in change at week 12||-14.676|-48.482|.002
72480193|NCT02647320|144486732|OTHER||LS Mean Difference|-6.2|STANDARD_ERROR_OF_MEAN|5.9||0.298|TWO_SIDED|90.0|-15.9|3.6|||Mixed Model Repeated Measure|||Difference in change at week 2||3.60|-15.90|.298
72623804|NCT00023595|144778235|SUPERIORITY|||||||0.077||||||24 months|Chi-squared|||||||0.077
72623805|NCT00023595|144778235|SUPERIORITY|||||||0.17||||||36 months|Chi-squared|||||||0.170
72623806|NCT00023595|144778236|SUPERIORITY|||||||0.63||||||Baseline|Wilcoxon (Mann-Whitney)|||||||0.63
72623807|NCT00023595|144778236|SUPERIORITY|||||||0.29||||||4 months|Wilcoxon (Mann-Whitney)|||||||0.29
72623808|NCT00023595|144778236|SUPERIORITY|||||||0.68||||||12 months|Wilcoxon (Mann-Whitney)|||||||0.68
72623809|NCT00023595|144778236|SUPERIORITY|||||||0.25||||||24 months|Wilcoxon (Mann-Whitney)|||||||0.25
72480194|NCT02647320|144486732|OTHER||LS Mean Difference|-16.3|STANDARD_ERROR_OF_MEAN|6.09||0.008|TWO_SIDED|90.0|-26.37|-6.27|||Mixed Model Repeated Measure|||Difference in change at week 2||-6.27|-26.37|.008
72480195|NCT02647320|144486732|OTHER||LS Mean Difference|-9.5|STANDARD_ERROR_OF_MEAN|5.32||0.074|TWO_SIDED|90.0|-18.31|-0.75|||Mixed Model Repeated Measure|||Difference in change at week 2||-0.75|-18.31|.074
72480196|NCT02647320|144486732|OTHER||LS Mean Difference|-27.2|STANDARD_ERROR_OF_MEAN|5.32|<|0.001|TWO_SIDED|90.0|-35.96|-18.38|||Mixed Model Repeated Measure|||Difference in change at week 2||-18.38|-35.96|<0.001
72480197|NCT02647320|144486733|OTHER||LS Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|5.96||0.84|TWO_SIDED|90.0|-11.04|8.63|||Mixed Model Repeated Measure|||Difference in change at week 4||8.63|-11.04|.840
72480198|NCT02647320|144486733|OTHER||LS Mean Difference|-11.9|STANDARD_ERROR_OF_MEAN|6.06||0.05|TWO_SIDED|90.0|-21.94|-1.91|||Mixed Model Repeated Measure|||Difference in change at week 4||-1.91|-21.94|.050
72480199|NCT02647320|144486733|OTHER||LS Mean Difference|-6.4|STANDARD_ERROR_OF_MEAN|5.31||0.227|TWO_SIDED|90.0|-15.21|2.33|||Mixed Model Repeated Measure|||Difference in change at week 4||2.33|-15.21|.227
72480200|NCT02647320|144486733|OTHER||LS Mean Difference|-13.1|STANDARD_ERROR_OF_MEAN|5.27||0.13|TWO_SIDED|90.0|-21.83|-4.43|||Mixed Model Repeated Measure|||Difference in change at week 4||-4.43|-21.83|0.13
72623810|NCT00023595|144778236|SUPERIORITY|||||||0.68||||||36 months|Wilcoxon (Mann-Whitney)|||||||0.68
72623811|NCT00023595|144778237|SUPERIORITY|||||||0.033||||||4 months|Chi-squared|H01 P-values were based on the Chi-Square test applied to maximum likelihood estimates derived from an adjusted mixed model.||||||0.033
72623812|NCT00023595|144778237|SUPERIORITY|||||||0.002||||||12 months|Chi-squared|||||||0.002
72623813|NCT00023595|144778237|SUPERIORITY|||||||0.015||||||24 months|Chi-squared|||||||0.015
72623814|NCT00023595|144778237|SUPERIORITY|||||||0.051||||||36 months|Chi-squared|||||||0.051
72623815|NCT00023595|144778238|SUPERIORITY|||||||0.26||||||Baseline|Wilcoxon (Mann-Whitney)|||||||0.26
72623816|NCT00023595|144778238|SUPERIORITY|||||||0.23||||||4 months|Wilcoxon (Mann-Whitney)|||||||0.23
72623817|NCT00023595|144778238|SUPERIORITY|||||||0.66||||||12 months|Wilcoxon (Mann-Whitney)|||||||0.66
72623818|NCT00023595|144778238|SUPERIORITY|||||||0.98||||||24 months|Wilcoxon (Mann-Whitney)|||||||0.98
72623819|NCT00023595|144778238|SUPERIORITY|||||||0.86||||||36 months|Wilcoxon (Mann-Whitney)|||||||0.86
72623820|NCT00023595|144778239|SUPERIORITY||||||<|0.001||||||4 months|Chi-squared|H01 P-values were based on the Chi-Square test applied to maximum likelihood estimates derived from an adjusted mixed model.||||||<0.001
72623821|NCT00023595|144778239|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
72623822|NCT00023595|144778239|SUPERIORITY|||||||0.006||||||24 months|Chi-squared|||||||0.006
72623823|NCT00023595|144778239|SUPERIORITY|||||||0.037||||||36 months|Chi-squared|||||||0.037
72623824|NCT00023595|144778240|SUPERIORITY|||||||0.53||||||Baseline|Wilcoxon (Mann-Whitney)|||||||0.53
72623825|NCT00023595|144778240|SUPERIORITY|||||||0.26||||||4 months|Wilcoxon (Mann-Whitney)|||||||0.26
72623826|NCT00023595|144778240|SUPERIORITY|||||||0.76||||||12 months|Wilcoxon (Mann-Whitney)|||||||0.76
72623827|NCT00023595|144778240|SUPERIORITY|||||||0.89||||||24 months|Wilcoxon (Mann-Whitney)|||||||0.89
72623828|NCT00023595|144778240|SUPERIORITY|||||||0.89||||||36 months|Wilcoxon (Mann-Whitney)|||||||0.89
72400591|NCT00975481|144308994|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.7658||||0.2287|TWO_SIDED|95.0|-1.7552|7.2868|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emin, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||7.2868|-1.7552|0.2287
72400592|NCT00975481|144308994|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.8366||||0.4267|TWO_SIDED|95.0|-2.7158|6.389|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emin, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||6.3890|-2.7158|0.4267
72400593|NCT00975481|144308994|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.3476||||0.314|TWO_SIDED|95.0|-2.2429|6.9381|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emin, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||6.9381|-2.2429|0.3140
72400594|NCT00975481|144308994|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.4724|||<|0.0001|TWO_SIDED|95.0|5.9992|14.9456|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emin, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||14.9456|5.9992|<0.0001
72400595|NCT00975481|144308994|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.5432|||<|0.0001|TWO_SIDED|95.0|5.032|14.0544|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emin, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||14.0544|5.0320|<0.0001
72400596|NCT00975481|144308994|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.0542|||<|0.0001|TWO_SIDED|95.0|5.494|14.6144|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emin, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||14.6144|5.4940|<0.0001
72400597|NCT00975481|144308995|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.4728|||<|0.0001|TWO_SIDED|95.0|9.4718|19.4737|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||19.4737|9.4718|<0.0001
72400598|NCT00975481|144308995|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|19.7284|||<|0.0001|TWO_SIDED|95.0|14.7131|24.7437|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||24.7437|14.7131|<0.0001
72400599|NCT00975481|144308995|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2088||||0.9348|TWO_SIDED|95.0|-4.8289|5.2466|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||5.2466|-4.8289|0.9348
72400600|NCT00975481|144308995|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.7271||||0.5009|TWO_SIDED|95.0|-6.7841|3.3299|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||3.3299|-6.7841|0.5009
72480201|NCT02647320|144486734|OTHER||LS Mean Difference|3.1|STANDARD_ERROR_OF_MEAN|6.55||0.642|TWO_SIDED|90.0|-7.77|13.88|||Mixed Model Repeated Measure|||Difference in change at week 8||13.88|-7.77|.642
72480202|NCT02647320|144486734|OTHER||LS Mean Difference|-4.4|STANDARD_ERROR_OF_MEAN|6.72||0.512|TWO_SIDED|90.0|-15.52|6.68|||Mixed Model Repeated Measure|||Difference in change at week 8||6.68|-15.52|.512
72623829|NCT00023595|144778241|SUPERIORITY||||||<|0.001||||||4 months|Chi-squared|H01 P-values were based on the Chi-Square test applied to maximum likelihood estimates derived from an adjusted mixed model.||||||<0.001
72480203|NCT02647320|144486734|OTHER||LS Mean Difference|-4.1|STANDARD_ERROR_OF_MEAN|5.81||0.486|TWO_SIDED|90.0|-13.66|5.54|||Mixed Model Repeated Measure|||Difference in change at week 8||5.54|-13.66|.486
72480204|NCT02647320|144486734|OTHER||LS Mean Difference|-16.7|STANDARD_ERROR_OF_MEAN|5.8||0.004|TWO_SIDED|90.0|-26.31|-7.16|||Mixed Model Repeated Measure|||Difference in change at week 8||-7.16|-26.31|.004
72623830|NCT00023595|144778241|SUPERIORITY||||||<|0.001||||||12 months|Chi-squared|||||||<0.001
72623831|NCT00023595|144778241|SUPERIORITY||||||<|0.001||||||24 months|Chi-squared|||||||<0.001
72623832|NCT00023595|144778241|SUPERIORITY|||||||0.01||||||36 months|Chi-squared|||||||0.010
72623833|NCT00023595|144778242|SUPERIORITY|||||||0.01||||||Baseline|Wilcoxon (Mann-Whitney)|||||||0.01
72623834|NCT00023595|144778242|SUPERIORITY|||||||0.74||||||4 months|Wilcoxon (Mann-Whitney)|||||||0.74
72400601|NCT00975481|144308995|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3325||||0.8975|TWO_SIDED|95.0|-5.4245|4.7595|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||4.7595|-5.4245|0.8975
72400602|NCT00975481|144308995|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.264|||<|0.0001|TWO_SIDED|95.0|-19.266|-9.2619|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-9.2619|-19.2660|<0.0001
72400603|NCT00975481|144308995|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.1999|||<|0.0001|TWO_SIDED|95.0|-21.2294|-11.1704|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-11.1704|-21.2294|<0.0001
72400604|NCT00975481|144308995|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.8053|||<|0.0001|TWO_SIDED|95.0|-19.8822|-9.7283|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-9.7283|-19.8822|<0.0001
72400605|NCT00975481|144308995|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.5195|||<|0.0001|TWO_SIDED|95.0|-24.4361|-14.603|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-14.6030|-24.4361|<0.0001
72400606|NCT00975481|144308995|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-21.4555|||<|0.0001|TWO_SIDED|95.0|-26.423|-16.488|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-16.4880|-26.4230|<0.0001
72400607|NCT00975481|144308995|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-20.0609|||<|0.0001|TWO_SIDED|95.0|-25.0872|-15.0345|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-15.0345|-25.0872|<0.0001
72400608|NCT00975481|144308996|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.1634|||<|0.0001|TWO_SIDED|95.0|1.9014|4.4254|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||4.4254|1.9014|<0.0001
72400609|NCT00975481|144308996|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.6706|||<|0.0001|TWO_SIDED|95.0|3.4066|5.9346|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||5.9346|3.4066|<0.0001
72480205|NCT02647320|144486735|OTHER||LS Mean Difference|-8.7|STANDARD_ERROR_OF_MEAN|8.11||0.285|TWO_SIDED|90.0|-22.09|4.7|||Mixed Model Repeated Measure|||Difference in change at week 12||4.70|-22.09|.285
72480206|NCT02647320|144486735|OTHER||LS Mean Difference|-18.6|STANDARD_ERROR_OF_MEAN|7.94||0.02|TWO_SIDED|90.0|-31.73|-5.49|||Mixed Model Repeated Measure|||Difference in change at week 12||-5.49|-31.73|.020
72480207|NCT02647320|144486735|OTHER||LS Mean Difference|-13.0|STANDARD_ERROR_OF_MEAN|7.03||0.067|TWO_SIDED|90.0|-24.6|-1.35|||Mixed Model Repeated Measure|||Difference in change at week 12||-1.35|-24.60|.067
72480208|NCT02647320|144486735|OTHER||LS Mean Difference|-17.4|STANDARD_ERROR_OF_MEAN|6.88||0.012|TWO_SIDED|90.0|-28.76|-6.03|||Mixed Model Repeated Measure|||Difference in change at week 12||-6.03|-28.76|.012
72480209|NCT00596427|144486737|SUPERIORITY_OR_OTHER||||||<|0.01||95.0|||||mixed-effects regression models|||Change from baseline between groups were compared.||||<0.01
72480210|NCT00596427|144486738|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||mixed-effects regression models|||Change from baseline between groups was compared.||||<0.001
72480211|NCT00596427|144486739|SUPERIORITY_OR_OTHER||||||<|0.1||95.0|||||mixed-effects regression models|This model had fixed effects of treatment, visit and treatment by visit interaction and a random subject effect.||Comparison of change from baseline between groups (treatment effect)||||<0.1
72480212|NCT00596427|144486740|SUPERIORITY_OR_OTHER||||||<|0.01||95.0|||||mixed-effects regression models|||||||<0.01
72480213|NCT00596427|144486741|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||mixed-effects regression models|||||||<0.05
72623835|NCT00023595|144778242|SUPERIORITY|||||||0.77||||||12 months|Wilcoxon (Mann-Whitney)|||||||0.77
72623836|NCT00023595|144778242|SUPERIORITY|||||||0.46||||||24 months|Wilcoxon (Mann-Whitney)|||||||0.46
72480214|NCT00596427|144486742|SUPERIORITY_OR_OTHER||||||<|0.1||95.0|||||mixed-effects regression models|||Change from baseline between groups were compared (treatment effect)||||<0.1
72480215|NCT00596427|144486743|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||mixed-effects regression models|||||||0.05
72480216|NCT00596427|144486744|SUPERIORITY_OR_OTHER|||||||0.6||95.0|||||mixed-effects regression models|||||||0.6
72480217|NCT00596427|144486745|SUPERIORITY_OR_OTHER|||||||0.3||95.0|||||mixed-effects regression models|||Treatment effect of change from baseline||||0.3
72480218|NCT00596427|144486746|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||mixed-effects regression models|||Treatment effect of change from baseline||||<0.0001
72480219|NCT00596427|144486747|SUPERIORITY_OR_OTHER||||||<|0.01||95.0|||||mixed-effects regression models|||Treatment effect of change from baseline||||<0.01
72480220|NCT00596427|144486748|SUPERIORITY_OR_OTHER||||||<|0.1||95.0|||||mixed-effects regression models|||||||<0.1
72480221|NCT00320541|144486749|SUPERIORITY_OR_OTHER|||||||0.117||95.0||||Statistical significance at 0.05 level was required.|Fisher Exact|||Assuming the response rate for the PB arm is 34% and the addition of gemcitabine will improve it to 54%, then a sample size of 170 evaluable participants (85 per arm) will give an 80% statistical power to detect the difference, using a 1-sided test at the significance level of 0.05. Confidence levels are exact binomial 95% Confidence Intervals.||||0.117
72480222|NCT00320541|144486750|SUPERIORITY_OR_OTHER|||||||0.247||95.0|||||Log Rank|||||||0.247
72480223|NCT00320541|144486751|SUPERIORITY_OR_OTHER|||||||0.475||95.0|||||Log Rank|||||||0.475
72480224|NCT00320541|144486752|SUPERIORITY_OR_OTHER|||||||0.01||95.0|||||ANCOVA|ANCOVA model included treatment arm and baseline assessment.||||||0.010
72480225|NCT00320541|144486753|SUPERIORITY_OR_OTHER|||||||0.119||95.0|||||ANCOVA|ANCOVA model included treatment arm and baseline assessment.||||||0.119
72480226|NCT00320541|144486754|SUPERIORITY_OR_OTHER|||||||0.023||95.0|||||ANCOVA|ANCOVA model included treatment arm and baseline assessment.||||||0.023
72480227|NCT00320541|144486755|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||ANCOVA|ANCOVA model included treatment arm and baseline assessment.||||||0.002
72480228|NCT00320541|144486756|SUPERIORITY_OR_OTHER|||||||0.004||95.0|||||ANCOVA|ANCOVA model included treatment arm and baseline assessment.||||||0.004
72480229|NCT00320541|144486757|SUPERIORITY_OR_OTHER|||||||0.067||95.0|||||ANCOVA|ANCOVA model included treatment arm and baseline assessment.||||||0.067
72480230|NCT00320541|144486758|SUPERIORITY_OR_OTHER|||||||0.036||95.0|||||ANCOVA|ANCOVA model included treatment arm and baseline assessment.||||||0.036
72480231|NCT03057977|144486759|SUPERIORITY|H0: There is no difference between the effect of placebo and the effect of empagliflozin.|Hazard Ratio (HR)|0.75|||<|0.0001|TWO_SIDED|95.04|0.65|0.86|||Regression, Cox||Comparison vs. Placebo \[T/P\]|"Model with terms for age, baseline eGFR (CKD-EPK)cr, region, baseline diabetes status, sex, baseline LVEF, and treatment.~alpha = 0.0496 (resulting from interim analysis) eGFR (CKP-EPI)cr: Glomerular filtration rate estimated by the chronic kidney disease epidemiology collaboration formula with serum creatinine measurement LVEF: Left ventricular ejection fraction."||0.86|0.65|<0.0001
72480232|NCT03057977|144486760|SUPERIORITY|H0: There is no difference between the effect of placebo and the effect of empagliflozin.|Hazard Ratio (HR)|0.7||||0.0003|TWO_SIDED|95.04|0.58|0.85|||Joint frailty model||HR vs placebo of recurrent HFF|"Model accounts for dependence between recurrent HHF and cardiovascular death, with terms for age, baseline eGFR (CKD-EPK)cr, region, baseline diabetes status, sex, baseline LVEF, and treatment.~eGFR (CKP-EPI)cr: Glomerular filtration rate estimated by the chronic kidney disease epidemiology collaboration formula with serum creatinine measurement LVEF: Left ventricular ejection fraction."||0.85|0.58|0.0003
72623837|NCT00023595|144778242|SUPERIORITY|||||||0.27||||||36 months|Wilcoxon (Mann-Whitney)|||||||0.27
72623838|NCT00023595|144778243|SUPERIORITY|||||||0.029||||||4 months|Chi-squared|H01 P-values were based on the Chi-Square test applied to maximum likelihood estimates derived from an adjusted mixed model.||||||0.029
72623839|NCT00023595|144778243|SUPERIORITY|||||||0.042||||||12 months|Chi-squared|||||||0.042
72623840|NCT00023595|144778243|SUPERIORITY|||||||0.3||||||24 months|Chi-squared|||||||0.30
72623841|NCT00023595|144778243|SUPERIORITY|||||||0.2||||||36 months|Chi-squared|||||||0.20
72623842|NCT00023595|144778244|SUPERIORITY|||||||0.98||||||Baseline|Wilcoxon (Mann-Whitney)|||||||0.98
72623843|NCT00023595|144778244|SUPERIORITY|||||||0.16||||||4 months|Wilcoxon (Mann-Whitney)|||||||0.16
72623844|NCT00023595|144778244|SUPERIORITY|||||||0.88||||||12 months|Wilcoxon (Mann-Whitney)|||||||0.88
72400610|NCT00975481|144308996|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1478||||0.8184|TWO_SIDED|95.0|-1.1217|1.4173|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||1.4173|-1.1217|0.8184
72400611|NCT00975481|144308996|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2211||||0.7324|TWO_SIDED|95.0|-1.054|1.4963|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||1.4963|-1.0540|0.7324
72400612|NCT00975481|144308996|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0946||||0.8844|TWO_SIDED|95.0|-1.1898|1.3791|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||1.3791|-1.1898|0.8844
72400613|NCT00975481|144308996|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.0156|||<|0.0001|TWO_SIDED|95.0|-4.2754|-1.7558|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-1.7558|-4.2754|<0.0001
72400614|NCT00975481|144308996|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.9423|||<|0.0001|TWO_SIDED|95.0|-4.2101|-1.6745|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-1.6745|-4.2101|<0.0001
72400615|NCT00975481|144308996|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.0688|||<|0.0001|TWO_SIDED|95.0|-4.3484|-1.7891|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-1.7891|-4.3484|<0.0001
72400616|NCT00975481|144308996|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.5228|||<|0.0001|TWO_SIDED|95.0|-5.7651|-3.2805|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-3.2805|-5.7651|<0.0001
72400617|NCT00975481|144308996|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.4495|||<|0.0001|TWO_SIDED|95.0|-5.7031|-3.1959|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-3.1959|-5.7031|<0.0001
72400618|NCT00975481|144308996|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.576|||<|0.0001|TWO_SIDED|95.0|-5.8438|-3.3081|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-3.3081|-5.8438|<0.0001
72400619|NCT00975481|144308997|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|46.0798|||<|0.0001|TWO_SIDED|95.0|34.0453|58.1142|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||58.1142|34.0453|<0.0001
72400620|NCT00975481|144308997|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|49.8771|||<|0.0001|TWO_SIDED|95.0|37.8247|61.9295|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||61.9295|37.8247|<0.0001
72509966|NCT05372575|144550707|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|2.46|||||TWO_SIDED|95.0|1.87|3.24|||||GMR=(GMC of 13vPnC VT- or Sp- Subgroup)/(GMC of non-13vPnC VT- or Sp- Subgroup)|GMR of 13vPnC Cohort/non-13vPnC Cohort in VT- or Sp- Subgroups for Serotype: 5||3.24|1.87|
72509967|NCT05372575|144550707|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|7.12|||||TWO_SIDED|95.0|5.05|10.03|||||GMR=(GMC of 13vPnC VT- or Sp- Subgroup)/(GMC of non-13vPnC VT- or Sp- Subgroup)|GMR of 13vPnC Cohort/non-13vPnC Cohort in VT- or Sp- Subgroups for Serotype: 6A||10.03|5.05|
72400621|NCT00975481|144308997|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5797||||0.9248|TWO_SIDED|95.0|-12.6918|11.5325|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||11.5325|-12.6918|0.9248
72400622|NCT00975481|144308997|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.3632||||0.5857|TWO_SIDED|95.0|-15.5264|8.8|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||8.8000|-15.5264|0.5857
72400623|NCT00975481|144308997|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.4225||||0.4768|TWO_SIDED|95.0|-7.827|16.6719|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||16.6719|-7.8270|0.4768
72400624|NCT00975481|144308997|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-46.6594|||<|0.0001|TWO_SIDED|95.0|-58.6804|-34.6385|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-34.6385|-58.6804|<0.0001
72400625|NCT00975481|144308997|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-49.443|||<|0.0001|TWO_SIDED|95.0|-61.5346|-37.3514|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-37.3514|-61.5346|<0.0001
72400626|NCT00975481|144308997|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-41.6573|||<|0.0001|TWO_SIDED|95.0|-53.86|-29.4546|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-29.4546|-53.8600|<0.0001
72400627|NCT00975481|144308997|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-50.4567|||<|0.0001|TWO_SIDED|95.0|-62.2925|-38.621|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-38.6210|-62.2925|<0.0001
72400628|NCT00975481|144308997|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-53.2403|||<|0.0001|TWO_SIDED|95.0|-65.1923|-41.2882|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-41.2882|-65.1923|<0.0001
72480233|NCT03057977|144486761|SUPERIORITY|H0: There is no difference between the effect of placebo and the effect of empagliflozin.|Treatment by time interaction|1.733|||<|0.0001|TWO_SIDED|99.9|0.669|2.796|||Random intercept random coef. model||Empa vs Placebo slope \[/year\]|"Random coefficient model allowing for random intercept and random slope per patient, with the same factors used for the primary endpoint (age, baseline eGFR (CKD-EPK)cr, region, baseline diabetes status, sex, baseline LVEF, and treatment) and additional factors time, treatment-by-time interaction, and baseline eGFR (CKD-EPI)cr-by-time interaction. Only on-treatment data from treated patients were used.~alpha=0.001"||2.796|0.669|<0.0001
72566651|NCT01421342|144663615|SUPERIORITY||Odds Ratio (OR)|1.31||||0.076|TWO_SIDED|95.0|0.97|1.75||Co-primary hypothesis: After ordering results from largest p-value to smallest (Hochberg approach) the comparison of Augmenting Antidepressant+Bupropion with Switching to Bupropion-SR was performed at the 0.05 significance level.|Regression, Logistic|Stratified by participating medical center|Represents relative odds of remission for Augmentation Antidepressant + Bupropion-SR / Switching to Bupropion-SR|||1.75|0.97|0.076
72623845|NCT00023595|144778244|SUPERIORITY|||||||0.95||||||24 months|Wilcoxon (Mann-Whitney)|||||||0.95
72623846|NCT00023595|144778244|SUPERIORITY|||||||0.48||||||36 months|Wilcoxon (Mann-Whitney)|||||||0.48
72623847|NCT00023595|144778245|SUPERIORITY||||||<|0.001||||||4 months|Chi-squared|H01 P-values were based on the Chi-Square test applied to maximum likelihood estimates derived from an adjusted mixed model.||||||<0.001
72623848|NCT00023595|144778245|SUPERIORITY||||||<|0.001||||||12 months|Chi-squared|||||||<0.001
72623849|NCT00023595|144778245|SUPERIORITY||||||<|0.001||||||24 months|Chi-squared|||||||<0.001
72623850|NCT00023595|144778245|SUPERIORITY|||||||0.001||||||36 months|Chi-squared|||||||0.001
72623851|NCT00023595|144778246|SUPERIORITY|||||||0.86||||||Baseline|Wilcoxon (Mann-Whitney)|||||||0.86
72623852|NCT00023595|144778246|SUPERIORITY|||||||0.39||||||4 months|Wilcoxon (Mann-Whitney)|||||||0.39
72623853|NCT00023595|144778246|SUPERIORITY|||||||0.65||||||12 months|Wilcoxon (Mann-Whitney)|||||||0.65
72623854|NCT00023595|144778246|SUPERIORITY|||||||0.15||||||24 months|Wilcoxon (Mann-Whitney)|||||||0.15
72623855|NCT00023595|144778246|SUPERIORITY|||||||0.68||||||36 months|Wilcoxon (Mann-Whitney)|||||||0.68
72400629|NCT00975481|144308997|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-45.4546|||<|0.0001|TWO_SIDED|95.0|-57.5459|-33.3633|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-33.3633|-57.5459|<0.0001
72480234|NCT03057977|144486762|OTHER||Hazard Ratio (HR)|0.5||||0.0019|TWO_SIDED|95.0|0.32|0.77|||Regression, Cox|Cox regression model with terms for age, baseline eGFR (CKD-EPK)cr, region, baseline diabetes status, sex, baseline LVEF, and treatment.|Comparison vs. Placebo|||0.77|0.32|0.0019
72480235|NCT03057977|144486763|OTHER||Hazard Ratio (HR)|0.69|||<|0.0001|TWO_SIDED|95.0|0.59|0.81|||Regression, Cox|Cox regression model with terms for age, baseline eGFR (CKD-EPK)cr, region, baseline diabetes status, sex, baseline LVEF, and treatment.|Comparison vs Placebo|||0.81|0.59|<0.0001
72480236|NCT03057977|144486764|OTHER||Hazard Ratio (HR)|0.92||||0.4133|TWO_SIDED|95.0|0.75|1.12|||Regression, Cox|Model with terms for age, baseline eGFR (CKD-EPI), region, baseline diabetes status, sex, baseline LVEF and treatment.|Comparison vs. Placebo|||1.12|0.75|0.4133
72480237|NCT03057977|144486765|OTHER||Hazard Ratio (HR)|0.92||||0.3536|TWO_SIDED|95.0|0.77|1.1|||Regression, Cox|Cox regression model with terms for age, baseline eGFR (CKD-EPI), region, baseline diabetes status, sex, baseline LVEF and treatment.|Comparison vs. placebo|||1.10|0.77|0.3536
72480238|NCT03057977|144486766|OTHER||Hazard Ratio (HR)|0.86||||0.3576|TWO_SIDED|95.0|0.62|1.19|||Regression, Cox|Cox regression model with terms for age, baseline eGFR (CDK-EPI), region, sex, baseline LVEF and treatment.|Comparison vs. placebo|||1.19|0.62|0.3576
72400630|NCT00975481|144308998|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|46.845|||<|0.0001|TWO_SIDED|95.0|34.6464|59.0436|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||59.0436|34.6464|<0.0001
72400631|NCT00975481|144308998|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|57.5013|||<|0.0001|TWO_SIDED|95.0|45.3036|69.6991|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||69.6991|45.3036|<0.0001
72400632|NCT00975481|144308998|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.0913||||0.4129|TWO_SIDED|95.0|-17.3421|7.1595|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||7.1595|-17.3421|0.4129
72480239|NCT03057977|144486767|OTHER||Difference of adjusted means|2.06|STANDARD_ERROR_OF_MEAN|0.97||0.034|TWO_SIDED|95.0|0.16|3.96|||Mixed Model|Mixed model for repeated measures (MMRM)|Comparison vs. placebo|Mixed model with age, baseline eGFR (CKD-EPI) as linear covariate(s) and region, baseline diabetes status, sex, baseline LVEF, week reachable, treatment by visit interaction, baseline KCCQ - Clinical Summary Score by Visit interaction as fixed effects. An unstructured covariance structure has been used.||3.96|0.16|0.0340
72480240|NCT03057977|144486768|OTHER||Hazard Ratio (HR)|0.85||||0.0065|TWO_SIDED|95.0|0.75|0.95|||Joint frailty model||Comparison vs. placebo|Joint frailty model with terms for age, baseline eGFR (CDK-EPI), region, sex, baseline diabetes status and baseline LVEF. Model accounts for dependence between recurrent all-cause hospitalizations and all-cause mortality.||0.95|0.75|0.0065
72480241|NCT03435497|144486784|SUPERIORITY|Using an intent-to-treat approach, intervention efficacy was tested with a hierarchical linear repeated-measures regressions in which the response may have come from either follow-up, and the predictors were an indicator for study arm, the baseline value of the outcome, the follow-up time-point, and covariates. Standard errors were adjusted for clustering at the individual level (ultimate clustering methods). Covariates were socio-demographics associated with the outcome at p\>.05.|Mean Difference (Net)|0.4|STANDARD_ERROR_OF_MEAN|0.2||0.017|TWO_SIDED||||||Regression, Linear|||||||.017
72480242|NCT03435497|144486785|SUPERIORITY|Using an intent-to-treat approach, intervention efficacy was tested with a hierarchical logistic repeated-measures regressions in which the response may have come from either follow-up, and the predictors were an indicator for study arm, the baseline value of the outcome, the follow-up time-point, and covariates. Standard errors were adjusted for clustering at the individual level (ultimate clustering methods). Covariates were socio-demographics associated with the outcome at p\>.05.|Mean Difference (Net)|0.5||||0.05|TWO_SIDED|95.0|0.2|1.6|||Regression, Logistic|||||1.6|0.2|.05
72509968|NCT05372575|144550707|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|7.78|||||TWO_SIDED|95.0|5.54|10.92|||||GMR=(GMC of 13vPnC VT- or Sp- Subgroup)/(GMC of non-13vPnC VT- or Sp- Subgroup)|GMR of 13vPnC Cohort/non-13vPnC Cohort in VT- or Sp- Subgroups for Serotype: 6B||10.92|5.54|
72509969|NCT05372575|144550707|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|10.4|||||TWO_SIDED|95.0|7.4|14.61|||||GMR=(GMC of 13vPnC VT- or Sp- Subgroup)/(GMC of non-13vPnC VT- or Sp- Subgroup)|GMR of 13vPnC Cohort/non-13vPnC Cohort in VT- or Sp- Subgroups for Serotype: 7F||14.61|7.40|
72400633|NCT00975481|144308998|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.1893||||0.8488|TWO_SIDED|95.0|-13.4954|11.1168|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||11.1168|-13.4954|0.8488
72400634|NCT00975481|144308998|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.1995||||0.4086|TWO_SIDED|95.0|-7.1963|17.5954|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||17.5954|-7.1963|0.4086
72400635|NCT00975481|144308998|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-51.9363|||<|0.0001|TWO_SIDED|95.0|-64.1108|-39.7618|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-39.7618|-64.1108|<0.0001
72400636|NCT00975481|144308998|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-48.0343|||<|0.0001|TWO_SIDED|95.0|-60.2801|-35.7885|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-35.7885|-60.2801|<0.0001
72400637|NCT00975481|144308998|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-41.6455|||<|0.0001|TWO_SIDED|95.0|-53.9964|-29.2946|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-29.2946|-53.9964|<0.0001
72400638|NCT00975481|144308998|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-62.5926|||<|0.0001|TWO_SIDED|95.0|-74.5881|-50.5971|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-50.5971|-74.5881|<0.0001
72400639|NCT00975481|144308998|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-58.6906|||<|0.0001|TWO_SIDED|95.0|-70.7965|-46.5847|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-46.5847|-70.7965|<0.0001
72400640|NCT00975481|144308998|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-52.3018|||<|0.0001|TWO_SIDED|95.0|-64.5427|-40.0609|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-40.0609|-64.5427|<0.0001
72400641|NCT00975481|144308999|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.4604||||0.0016|TWO_SIDED|95.0|6.321|26.5998|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||26.5998|6.3210|0.0016
72400642|NCT00975481|144308999|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|27.9971|||<|0.0001|TWO_SIDED|95.0|17.8247|38.1696|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||38.1696|17.8247|<0.0001
72400643|NCT00975481|144308999|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.1425||||0.8254|TWO_SIDED|95.0|-11.3591|9.0742|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||9.0742|-11.3591|0.8254
72400644|NCT00975481|144308999|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.747||||0.8858|TWO_SIDED|95.0|-9.5075|11.0015|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||11.0015|-9.5075|0.8858
72400645|NCT00975481|144308999|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.4279||||0.5128|TWO_SIDED|95.0|-6.8972|13.7529|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||13.7529|-6.8972|0.5128
72400646|NCT00975481|144308999|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.6028||||0.0008|TWO_SIDED|95.0|-27.7485|-7.4572|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-7.4572|-27.7485|0.0008
72400647|NCT00975481|144308999|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.7134||||0.0028|TWO_SIDED|95.0|-25.9136|-5.5132|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-5.5132|-25.9136|0.0028
72400648|NCT00975481|144308999|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.0325||||0.0135|TWO_SIDED|95.0|-23.3295|-2.7355|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-2.7355|-23.3295|0.0135
72400649|NCT00975481|144308999|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-29.1396|||<|0.0001|TWO_SIDED|95.0|-39.1071|-19.1721|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-19.1721|-39.1071|<0.0001
72400650|NCT00975481|144308999|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-27.2502|||<|0.0001|TWO_SIDED|95.0|-37.3224|-17.178|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-17.1780|-37.3224|<0.0001
72400651|NCT00975481|144308999|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-24.5693|||<|0.0001|TWO_SIDED|95.0|-34.7614|-14.3772|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-14.3772|-34.7614|<0.0001
72400652|NCT00975481|144309000|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.2535||||0.0005|TWO_SIDED|95.0|0.5623|1.9446|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||1.9446|0.5623|0.0005
72480243|NCT03435497|144486786|SUPERIORITY|Using an intent-to-treat approach, intervention efficacy was tested with a hierarchical linear repeated-measures regressions in which the response may have come from either follow-up, and the predictors were an indicator for study arm, the baseline value of the outcome, the follow-up time-point, and covariates. Standard errors were adjusted for clustering at the individual level (ultimate clustering methods). Covariates were socio-demographics associated with the outcome at p\>.05.|Mean Difference (Net)|0.01|STANDARD_ERROR_OF_MEAN|0.02||0.48|TWO_SIDED||||||Regression, Linear|||||||0.48
72480244|NCT03435497|144486787|SUPERIORITY|Using an intent-to-treat approach, intervention efficacy was tested with a hierarchical linear repeated-measures regressions in which the response may have come from either follow-up, and the predictors were an indicator for study arm, the baseline value of the outcome, the follow-up time-point, and covariates. Standard errors were adjusted for clustering at the individual level (ultimate clustering methods). Covariates were socio-demographics associated with the outcome at p\>.05.|Mean Difference (Net)|-0.3|STANDARD_ERROR_OF_MEAN|0.1||0.012|TWO_SIDED||||||Regression, Linear|||||||0.012
72480245|NCT03435497|144486788|SUPERIORITY|Using an intent-to-treat approach, intervention efficacy was tested with a hierarchical logistic repeated-measures regressions in which the response may have come from either follow-up, and the predictors were an indicator for study arm, the baseline value of the outcome, the follow-up time-point, and covariates. Standard errors were adjusted for clustering at the individual level (ultimate clustering methods). Covariates were socio-demographics associated with the outcome at p\>.05.|Odds Ratio (OR)|10.0||||0.022|TWO_SIDED|95.0|1.5|67.7|||Regression, Logistic|||||67.7|1.5|0.022
72480246|NCT03645057|144486798|SUPERIORITY|||||||0.433|||||||Wilcoxon rank sum test|||||||0.433
72480247|NCT03645057|144486799|SUPERIORITY|||||||0.836|||||||Wilcoxon rank sum test|||||||0.836
72623856|NCT00023595|144778247|SUPERIORITY||||||<|0.001||||||4 months|Chi-squared|H01 P-values were based on the Chi-Square test applied to maximum likelihood estimates derived from an adjusted mixed model.||||||<0.001
72480248|NCT03645057|144486800|SUPERIORITY|||||||0.073|||||||Wilcoxon rank sum test|||||||0.073
72480249|NCT03645057|144486801|SUPERIORITY|||||||0.989|||||||Wilcoxon rank sum test|||||||0.989
72480250|NCT03645057|144486802|SUPERIORITY|||||||0.565|||||||Wilcoxon rank sum test|||||||0.565
72480251|NCT03645057|144486803|SUPERIORITY|||||||0.479|||||||Wilcoxon rank sum test|||||||0.479
72480252|NCT03645057|144486804|SUPERIORITY|||||||0.577|||||||Wilcoxon rank sum test|||||||0.577
72623857|NCT00023595|144778247|SUPERIORITY||||||<|0.001||||||12 months|Chi-squared|||||||<0.001
72480253|NCT03645057|144486805|SUPERIORITY|||||||0.439|||||||Wilcoxon (Mann-Whitney)|||||||0.439
72623858|NCT00023595|144778247|SUPERIORITY|||||||0.001||||||24 months|Chi-squared|||||||0.001
72623859|NCT00023595|144778247|SUPERIORITY|||||||0.001|||||||Chi-squared|||||||0.001
72623860|NCT00023595|144778248|SUPERIORITY|||||||0.96||||||Baseline|Wilcoxon (Mann-Whitney)|||||||0.96
72623861|NCT00023595|144778248|SUPERIORITY|||||||0.53||||||4 months|Wilcoxon (Mann-Whitney)|||||||0.53
72400653|NCT00975481|144309000|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.501|||<|0.0001|TWO_SIDED|95.0|2.8073|4.1948|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||4.1948|2.8073|<0.0001
72400654|NCT00975481|144309000|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3418||||0.3347|TWO_SIDED|95.0|-0.3559|1.0396|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||1.0396|-0.3559|0.3347
72566652|NCT01421342|144663615|SUPERIORITY||Odds Ratio (OR)|1.42||||0.018|TWO_SIDED|95.0|1.06|1.89||Co-primary hypothesis: Second ordered test after ordering largest p-value to smallest (Hochberg approach) the comparison of Augmentation Antidepressant + Aripiprazole with Switching to Bupropion-SR was performed at the 0.025 significance level.|Regression, Logistic|Stratified by participating medical center|Represents relative odds of remission for Augmentation Antidepressant + Aripiprazole / Switching to Bupropion-SR|Co-primary hypothesis: After ordering results form largest p-value to smallest (Hochberg approach) the comparison of Augmentation Antidepressant + Aripiprazole with Switching to Bupropion-SR was performed at the 0.025 significance level.||1.89|1.06|0.018
72566653|NCT01421342|144663615|SUPERIORITY||Odds Ratio (OR)|1.11||||0.46|TWO_SIDED|95.0|0.84|1.48||Following the gate-keeping strategy of the analysis plan, complete the comparison of Augmentation Antidepressant + Aripiprazole vs. Augmentation Antidepressant + Bupropion-SR was evaluated at the 0.05 significance level.|Regression, Logistic||Represents relative odds of remission for Augmentation Antidepressant + Aripiprazole / Augmentation Antidepressant + Bupropion-SR|If either if the first two hypothesis tests for the co-primary hypotheses were significant, perform the test of Augmentation Antidepressant + Aripiprazole vs. Augmentation Antidepressant + Bupropion-SR at the 0.05 significance level.||1.48|0.84|0.46
72480254|NCT03645057|144486806|SUPERIORITY|||||||0.242|||||||Wilcoxon rank sum test|||||||0.242
72480255|NCT01313637|144486830|SUPERIORITY_OR_OTHER||Least squares mean difference|0.16|||<|0.001|TWO_SIDED|95.0|0.122|0.198|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least squares mean difference=UMEC 125 µg minus Placebo.|||0.198|0.122|<0.001
72623862|NCT00023595|144778248|SUPERIORITY|||||||0.37||||||12 months|Wilcoxon (Mann-Whitney)|||||||0.37
72623863|NCT00023595|144778248|SUPERIORITY|||||||0.78||||||24 months|Wilcoxon (Mann-Whitney)|||||||0.78
72623864|NCT00023595|144778248|SUPERIORITY|||||||0.21||||||36 months|Wilcoxon (Mann-Whitney)|||||||0.21
72623865|NCT00023595|144778249|SUPERIORITY|||||||0.007||||||4 months|Chi-squared|H01 P-values were based on the Chi-Square test applied to maximum likelihood estimates derived from an adjusted mixed model.||||||0.007
72623866|NCT00023595|144778249|SUPERIORITY|||||||0.003||||||12 months|Chi-squared|||||||0.003
72623867|NCT00023595|144778249|SUPERIORITY|||||||0.023||||||24 months|Chi-squared|||||||0.023
72623868|NCT00023595|144778249|SUPERIORITY|||||||0.06||||||36 months|Chi-squared|||||||0.060
72623869|NCT00023595|144778250|SUPERIORITY|||||||0.31||||||Baseline|Wilcoxon (Mann-Whitney)|||||||0.31
72623870|NCT00023595|144778250|SUPERIORITY|||||||0.43||||||4 months|Wilcoxon (Mann-Whitney)|||||||0.43
72623871|NCT00023595|144778250|SUPERIORITY|||||||0.57||||||12 months|Wilcoxon (Mann-Whitney)|||||||0.57
72623872|NCT00023595|144778250|SUPERIORITY|||||||0.95||||||24 months|Wilcoxon (Mann-Whitney)|||||||0.95
72623873|NCT00023595|144778250|SUPERIORITY|||||||0.38||||||36 months|Wilcoxon (Mann-Whitney)|||||||0.38
72623874|NCT00023595|144778251|SUPERIORITY|||||||0.86||||||Baseline|Chi-squared|All P-values were based on the Likelihood Ratio Chi-Square test.||||||0.86
72623875|NCT00023595|144778251|SUPERIORITY|||||||0.78||||||4 months|Chi-squared|All P-values were based on the Likelihood Ratio Chi-Square test.||||||0.78
72623876|NCT00023595|144778251|SUPERIORITY|||||||0.55||||||12 months|Chi-squared|All P-values were based on the Likelihood Ratio Chi-Square test.||||||0.55
72623877|NCT00023595|144778251|SUPERIORITY|||||||0.027||||||24 months|Chi-squared|All P-values were based on the Likelihood Ratio Chi-Square test.||||||0.027
72623878|NCT00023595|144778251|SUPERIORITY|||||||0.031||||||36 months|Chi-squared|All P-values were based on the Likelihood Ratio Chi-Square test.||||||0.031
72623879|NCT00023595|144778252|SUPERIORITY|||||||0.4||||||Baseline|Chi-squared|All P-values were based on the Likelihood Ratio Chi-Square test.||||||0.40
72623880|NCT00023595|144778252|SUPERIORITY|||||||0.42||||||4 months|Chi-squared|All P-values were based on the Likelihood Ratio Chi-Square test.||||||0.42
72623881|NCT00023595|144778252|SUPERIORITY|||||||0.41||||||12 months|Chi-squared|All P-values were based on the Likelihood Ratio Chi-Square test.||||||0.41
72623882|NCT00023595|144778252|SUPERIORITY|||||||0.25||||||24 months|Chi-squared|All P-values were based on the Likelihood Ratio Chi-Square test.||||||0.25
72623883|NCT00023595|144778252|SUPERIORITY|||||||0.25||||||36 months|Chi-squared|All P-values were based on the Likelihood Ratio Chi-Square test.||||||0.25
72623884|NCT00023595|144778253|SUPERIORITY|||||||0.002||||||4 months|Chi-squared|H01 P-values were based on the Chi-Square test applied to maximum likelihood estimates derived from an adjusted mixed model.||||||0.002
72623885|NCT00023595|144778253|SUPERIORITY|||||||0.007||||||12 months|Chi-squared|||||||0.007
72623886|NCT00023595|144778253|SUPERIORITY|||||||0.049||||||24 months|Chi-squared|||||||0.049
72623887|NCT00023595|144778253|SUPERIORITY|||||||0.038||||||36 months|Chi-squared|||||||0.038
72623888|NCT00023595|144778254|SUPERIORITY|||||||0.4||||||Baseline|Wilcoxon (Mann-Whitney)|||||||0.40
72623889|NCT00023595|144778254|SUPERIORITY|||||||0.37||||||4 months|Wilcoxon (Mann-Whitney)|||||||0.37
72623890|NCT00023595|144778254|SUPERIORITY|||||||0.98||||||12 months|Wilcoxon (Mann-Whitney)|||||||0.98
72623891|NCT00023595|144778254|SUPERIORITY|||||||0.15||||||24 months|Wilcoxon (Mann-Whitney)|||||||0.15
72623892|NCT00023595|144778254|SUPERIORITY|||||||0.04||||||36 months|Wilcoxon (Mann-Whitney)|||||||0.04
72400655|NCT00975481|144309000|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3208||||0.3678|TWO_SIDED|95.0|-0.3808|1.0225|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||1.0225|-0.3808|0.3678
72400656|NCT00975481|144309000|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.036||||0.9197|TWO_SIDED|95.0|-0.6686|0.7406|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||0.7406|-0.6686|0.9197
72400657|NCT00975481|144309000|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9117||||0.0099|TWO_SIDED|95.0|-1.6013|-0.222|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-0.2220|-1.6013|0.0099
72400658|NCT00975481|144309000|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9326||||0.0088|TWO_SIDED|95.0|-1.6269|-0.2384|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-0.2384|-1.6269|0.0088
72400659|NCT00975481|144309000|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.2175||||0.0008|TWO_SIDED|95.0|-1.9171|-0.5178|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-0.5178|-1.9171|0.0008
72400660|NCT00975481|144309000|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.1592|||<|0.0001|TWO_SIDED|95.0|-3.838|-2.4804|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-2.4804|-3.8380|<0.0001
72400661|NCT00975481|144309000|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.1802|||<|0.0001|TWO_SIDED|95.0|-3.8656|-2.4947|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-2.4947|-3.8656|<0.0001
72400662|NCT00975481|144309000|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.465|||<|0.0001|TWO_SIDED|95.0|-4.1583|-2.7717|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-2.7717|-4.1583|<0.0001
72400663|NCT00975481|144309001|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.2943|||<|0.0001|TWO_SIDED|95.0|4.0783|6.5102|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||6.5102|4.0783|<0.0001
72400664|NCT00975481|144309001|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.8983|||<|0.0001|TWO_SIDED|95.0|5.6799|8.1167|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||8.1167|5.6799|<0.0001
72509970|NCT05372575|144550707|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|4.07|||||TWO_SIDED|95.0|3.04|5.47|||||GMR=(GMC of 13vPnC VT- or Sp- Subgroup)/(GMC of non-13vPnC VT- or Sp- Subgroup)|GMR of 13vPnC Cohort/non-13vPnC Cohort in VT- or Sp- Subgroups for Serotype: 9V||5.47|3.04|
72509971|NCT05372575|144550707|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|60.32|||||TWO_SIDED|95.0|37.25|97.67|||||GMR=(GMC of 13vPnC VT- or Sp- Subgroup)/(GMC of non-13vPnC VT- or Sp- Subgroup)|GMR of 13vPnC Cohort/non-13vPnC Cohort in VT- or Sp- Subgroups for Serotype: 14||97.67|37.25|
72509972|NCT05372575|144550707|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|17.35|||||TWO_SIDED|95.0|11.37|26.47|||||GMR=(GMC of 13vPnC VT- or Sp- Subgroup)/(GMC of non-13vPnC VT- or Sp- Subgroup)|GMR of 13vPnC Cohort/non-13vPnC Cohort in VT- or Sp- Subgroups for Serotype: 18C||26.47|11.37|
72623893|NCT00023595|144778255|SUPERIORITY|||||||0.036||||||4 months|Chi-squared|H01 P-values were based on the Chi-Square test applied to maximum likelihood estimates derived from an adjusted mixed model.||||||0.036
72400665|NCT00975481|144309001|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.6545||||0.2917|TWO_SIDED|95.0|-0.5676|1.8767|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||1.8767|-0.5676|0.2917
72400666|NCT00975481|144309001|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.8489||||0.1738|TWO_SIDED|95.0|-0.3784|2.0763|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||2.0763|-0.3784|0.1738
72400667|NCT00975481|144309001|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.9372||||0.1373|TWO_SIDED|95.0|-0.3024|2.1767|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||2.1767|-0.3024|0.1373
72400668|NCT00975481|144309001|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.6397|||<|0.0001|TWO_SIDED|95.0|-5.8537|-3.4257|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-3.4257|-5.8537|<0.0001
72400669|NCT00975481|144309001|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.4453|||<|0.0001|TWO_SIDED|95.0|-5.6662|-3.2244|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-3.2244|-5.6662|<0.0001
72400670|NCT00975481|144309001|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.3571|||<|0.0001|TWO_SIDED|95.0|-5.5887|-3.1255|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-3.1255|-5.5887|<0.0001
72400671|NCT00975481|144309001|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.2437|||<|0.0001|TWO_SIDED|95.0|-7.4397|-5.0477|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-5.0477|-7.4397|<0.0001
72400672|NCT00975481|144309001|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.0493|||<|0.0001|TWO_SIDED|95.0|-7.2568|-4.8419|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-4.8419|-7.2568|<0.0001
72400673|NCT00975481|144309001|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.9611|||<|0.0001|TWO_SIDED|95.0|-7.1812|-4.741|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-4.7410|-7.1812|<0.0001
72400674|NCT00975481|144309002|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-26.6205|||<|0.0001|TWO_SIDED|95.0|-33.1192|-20.1219|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-20.1219|-33.1192|<0.0001
72400675|NCT00975481|144309002|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-32.5724|||<|0.0001|TWO_SIDED|95.0|-39.1073|-26.0375|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-26.0375|-39.1073|<0.0001
72480256|NCT01313637|144486830|SUPERIORITY_OR_OTHER||Least squares mean difference|0.124|||<|0.001|TWO_SIDED|95.0|0.086|0.162|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least squares mean difference=VI 25 µg minus Placebo.|||0.162|0.086|<0.001
72623894|NCT00023595|144778255|SUPERIORITY|||||||0.043||||||12 months|Chi-squared|||||||0.043
72623895|NCT00023595|144778255|SUPERIORITY|||||||0.018||||||24 months|Chi-squared|||||||0.018
72623896|NCT00023595|144778255|SUPERIORITY|||||||0.037||||||36 months|Chi-squared|||||||0.037
72623897|NCT00023595|144778256|SUPERIORITY|||||||0.75||||||Baseline|Wilcoxon (Mann-Whitney)|||||||0.75
72623898|NCT00023595|144778256|SUPERIORITY|||||||0.72||||||4 months|Wilcoxon (Mann-Whitney)|||||||0.72
72623899|NCT00023595|144778256|SUPERIORITY|||||||0.77||||||12 months|Wilcoxon (Mann-Whitney)|||||||0.77
72480257|NCT01313637|144486830|SUPERIORITY_OR_OTHER||Least squares mean difference|0.238|||<|0.001|TWO_SIDED|95.0|0.2|0.276|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least squares mean difference=UMEC/VI 125/25 µg minus Placebo.|||0.276|0.200|<0.001
72480258|NCT01313637|144486830|SUPERIORITY_OR_OTHER||Least squares mean difference|0.079|||<|0.001|TWO_SIDED|95.0|0.046|0.112|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least squares mean difference=UMEC/VI 125/25 minus UMEC 125 µg.|||0.112|0.046|<0.001
72480259|NCT01313637|144486830|SUPERIORITY_OR_OTHER||Least squares mean difference|0.114|||<|0.001|TWO_SIDED|95.0|0.081|0.148|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least squares mean difference=UMEC/VI 125/25 minus VI 25 µg.|||0.148|0.081|<0.001
72480260|NCT01037244|144486849|SUPERIORITY_OR_OTHER||Difference in Least Square (LS) Means|5.04|||<|0.0001|TWO_SIDED|95.0|3.36|6.73|||ANCOVA|Baseline Domain Score and pooled sites as covariates.||540 subjects were randomized with 1:1:1:1 randomization scheme to achieve approximately 135 eligible subjects randomized to each of the 4 treatment groups (WC3043 50 mg, 100 mg, 150 mg, and placebo). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure.||6.73|3.36|<0.0001
72480261|NCT01037244|144486849|SUPERIORITY_OR_OTHER||Difference in LS Means|7.18|||<|0.0001|TWO_SIDED|95.0|5.49|8.86|||ANCOVA|Baseline domain score and pooled sites as covariates.||540 subjects were randomized with 1:1:1:1 randomization scheme to achieve approximately 135 eligible subjects randomized to each of the 4 treatment groups (WC3043 50 mg, 100 mg, 150 mg, and placebo). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure.||8.86|5.49|<0.0001
72480262|NCT01037244|144486849|SUPERIORITY_OR_OTHER||Difference in LS Means|7.95|||<|0.0001|TWO_SIDED|95.0|6.27|9.63|||ANCOVA|Baseline domain score and pooled sites as covariates.||540 subjects were randomized with 1:1:1:1 randomization scheme to achieve approximately 135 eligible subjects randomized to each of the 4 treatment groups (WC3043 50 mg, 100 mg, 150 mg, and placebo). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure.||9.63|6.27|<0.0001
72480263|NCT01037244|144486850|SUPERIORITY_OR_OTHER||Difference in LS Means|18.6|||<|0.0001|TWO_SIDED|95.0|11.72|25.48|||ANCOVA|"P-values are obtained from ANCOVA model with proportion of yes responses during the baseline period and pooled site as covariates."||540 subjects were randomized with 1:1:1:1 randomization scheme to achieve approximately 135 eligible subjects randomized to each of the 4 treatment groups (WC3043 50 mg, 100 mg, 150 mg, and placebo). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure.||25.48|11.72|<0.0001
72480264|NCT01037244|144486850|SUPERIORITY_OR_OTHER||Difference in LS Means|29.02|||<|0.0001|TWO_SIDED|95.0|22.13|35.9|||ANCOVA|"P-values are obtained from ANCOVA model with proportion of yes responses during the baseline period and pooled site as covariates."||540 subjects were randomized with 1:1:1:1 randomization scheme to achieve approximately 135 eligible subjects randomized to each of the 4 treatment groups (WC3043 50 mg, 100 mg, 150 mg, and placebo). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure.||35.90|22.13|<0.0001
72480265|NCT01037244|144486850|SUPERIORITY_OR_OTHER||Difference in LS Means|31.51|||<|0.0001|TWO_SIDED|95.0|24.68|38.34|||ANCOVA|"P-values are obtained from ANCOVA model with proportion of yes responses during the baseline period and pooled site as covariates."||540 subjects were randomized with 1:1:1:1 randomization scheme to achieve approximately 135 eligible subjects randomized to each of the 4 treatment groups (WC3043 50 mg, 100 mg, 150 mg, and placebo). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure.||38.34|24.68|<0.0001
72480266|NCT01037244|144486851|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Cochran-Armitage test|||540 subjects were randomized with 1:1:1:1 randomization scheme to achieve approximately 135 eligible subjects randomized to each of the 4 treatment groups (WC3043 50 mg, 100 mg, 150 mg, and placebo). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure.||||<0.0001
72480267|NCT01037244|144486851|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Chi-squared|||540 subjects were randomized with 1:1:1:1 randomization scheme to achieve approximately 135 eligible subjects randomized to each of the 4 treatment groups (WC3043 50 mg, 100 mg, 150 mg, and placebo). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure.||||<0.0001
72509973|NCT05372575|144550707|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|4.11|||||TWO_SIDED|95.0|3.0|5.62|||||GMR=(GMC of 13vPnC VT- or Sp- Subgroup)/(GMC of non-13vPnC VT- or Sp- Subgroup)|GMR of 13vPnC Cohort/non-13vPnC Cohort in VT- or Sp- Subgroups for Serotype: 19A||5.62|3.00|
72623900|NCT00023595|144778256|SUPERIORITY|||||||0.52||||||24 months|Wilcoxon (Mann-Whitney)|||||||0.52
72623901|NCT00023595|144778256|SUPERIORITY|||||||0.12||||||36 months|Wilcoxon (Mann-Whitney)|||||||0.12
72623902|NCT00023595|144778257|SUPERIORITY|||||||0.0002||||||4 months|Chi-squared|H01 P-values were based on the Chi-Square test applied to maximum likelihood estimates derived from an adjusted mixed model.||||||0.0002
72623903|NCT00023595|144778257|SUPERIORITY||||||<|0.0001||||||12 months|Chi-squared|||||||<0.0001
72623904|NCT00023595|144778257|SUPERIORITY|||||||0.009||||||24 months|Chi-squared|||||||0.009
72400676|NCT00975481|144309002|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.8966||||0.5685|TWO_SIDED|95.0|-4.6607|8.454|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||8.4540|-4.6607|0.5685
72400677|NCT00975481|144309002|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.5761||||0.2848|TWO_SIDED|95.0|-10.159|3.0068|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||3.0068|-10.1590|0.2848
72400678|NCT00975481|144309002|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.1754||||0.344|TWO_SIDED|95.0|-9.7855|3.4347|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||3.4347|-9.7855|0.3440
72400679|NCT00975481|144309002|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|28.5172|||<|0.0001|TWO_SIDED|95.0|22.0454|34.989|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||34.9890|22.0454|<0.0001
72400680|NCT00975481|144309002|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|23.0445|||<|0.0001|TWO_SIDED|95.0|16.5383|29.5506|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||29.5506|16.5383|<0.0001
72400681|NCT00975481|144309002|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|23.4452|||<|0.0001|TWO_SIDED|95.0|16.8772|30.0131|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||30.0131|16.8772|<0.0001
72400682|NCT00975481|144309002|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|34.469|||<|0.0001|TWO_SIDED|95.0|28.1136|40.8244|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||40.8244|28.1136|<0.0001
72400683|NCT00975481|144309002|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|28.9963|||<|0.0001|TWO_SIDED|95.0|22.5734|35.4192|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||35.4192|22.5734|<0.0001
72400684|NCT00975481|144309002|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|29.397|||<|0.0001|TWO_SIDED|95.0|22.8946|35.8994|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||35.8994|22.8946|<0.0001
72400685|NCT00975481|144309003|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|46.6044|||<|0.0001|TWO_SIDED|95.0|33.4091|59.7996|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||59.7996|33.4091|<0.0001
72400686|NCT00975481|144309003|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|50.7222|||<|0.0001|TWO_SIDED|95.0|37.5038|63.9407|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||63.9407|37.5038|<0.0001
72400687|NCT00975481|144309003|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6987||||0.9174|TWO_SIDED|95.0|-13.9815|12.584|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||12.5840|-13.9815|0.9174
72400688|NCT00975481|144309003|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.5629||||0.5002|TWO_SIDED|95.0|-17.9006|8.7749|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||8.7749|-17.9006|0.5002
72400689|NCT00975481|144309003|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.3982||||0.3482|TWO_SIDED|95.0|-7.0337|19.8301|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||19.8301|-7.0337|0.3482
72400690|NCT00975481|144309003|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-47.3031|||<|0.0001|TWO_SIDED|95.0|-60.4869|-34.1193|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-34.1193|-60.4869|<0.0001
72400691|NCT00975481|144309003|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-51.1672|||<|0.0001|TWO_SIDED|95.0|-64.4276|-37.9069|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-37.9069|-64.4276|<0.0001
72400692|NCT00975481|144309003|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-40.2062|||<|0.0001|TWO_SIDED|95.0|-53.589|-26.8234|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-26.8234|-53.5890|<0.0001
72400693|NCT00975481|144309003|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-51.421|||<|0.0001|TWO_SIDED|95.0|-64.3974|-38.4445|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-38.4445|-64.3974|<0.0001
72400694|NCT00975481|144309003|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-55.2851|||<|0.0001|TWO_SIDED|95.0|-68.3904|-42.1798|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-42.1798|-68.3904|<0.0001
72400695|NCT00975481|144309003|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-44.3241|||<|0.0001|TWO_SIDED|95.0|-57.5825|-31.0656|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-31.0656|-57.5825|<0.0001
72400696|NCT00975481|144309004|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-46.3823|||<|0.0001|TWO_SIDED|95.0|-62.1244|-30.6401|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For placebo, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI was obtained from the model.||-30.6401|-62.1244|<0.0001
72400697|NCT00975481|144309004|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-51.5199|||<|0.0001|TWO_SIDED|95.0|-67.2633|-35.7765|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For placebo, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-35.7765|-67.2633|<0.0001
72400698|NCT00975481|144309004|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.0366||||0.4524|TWO_SIDED|95.0|-9.7924|21.8657|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For placebo, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||21.8657|-9.7924|0.4524
72400699|NCT00975481|144309004|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.4423||||0.762|TWO_SIDED|95.0|-13.4599|18.3446|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For placebo, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||18.3446|-13.4599|0.7620
72400700|NCT00975481|144309004|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1573||||0.9846|TWO_SIDED|95.0|-15.8609|16.1754|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For placebo, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||16.1754|-15.8609|0.9846
72480268|NCT01037244|144486851|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Chi-squared|||540 subjects were randomized with 1:1:1:1 randomization scheme to achieve approximately 135 eligible subjects randomized to each of the 4 treatment groups (WC3043 50 mg, 100 mg, 150 mg, and placebo). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure.||||<0.0001
72623905|NCT00023595|144778257|SUPERIORITY|||||||0.32||||||36 months|Chi-squared|||||||0.32
72480269|NCT01037244|144486851|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Chi-squared|||540 subjects were randomized with 1:1:1:1 randomization scheme to achieve approximately 135 eligible subjects randomized to each of the 4 treatment groups (WC3043 50 mg, 100 mg, 150 mg, and placebo). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure.||||<0.0001
72480270|NCT01037244|144486852|SUPERIORITY_OR_OTHER||Difference in LS Means|0.44|||<|0.0001|TWO_SIDED|95.0|0.3|0.59|||ANCOVA|p-values are obtained from ANCOVA model with baseline PSAE score and pooled site as covariates.||540 subjects were randomized with 1:1:1:1 randomization scheme to achieve approximately 135 eligible subjects randomized to each of the 4 treatment groups (WC3043 50 mg, 100 mg, 150 mg, and placebo). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure.||0.59|0.30|<0.0001
72480271|NCT01037244|144486852|SUPERIORITY_OR_OTHER||Difference in LS Means|0.68|||<|0.0001|TWO_SIDED|95.0|0.54|0.83|||ANCOVA|p-values are obtained from ANCOVA model with baseline PSAE score and pooled site as covariates.||540 subjects were randomized with 1:1:1:1 randomization scheme to achieve approximately 135 eligible subjects randomized to each of the 4 treatment groups (WC3043 50 mg, 100 mg, 150 mg, and placebo). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure.||0.83|0.54|<0.0001
72480272|NCT01037244|144486852|SUPERIORITY_OR_OTHER||Difference in LS Means|0.8|||<|0.0001|TWO_SIDED|95.0|0.66|0.95|||ANCOVA|p-values are obtained from ANCOVA model with baseline PSAE score and pooled site as covariates.||540 subjects were randomized with 1:1:1:1 randomization scheme to achieve approximately 135 eligible subjects randomized to each of the 4 treatment groups (WC3043 50 mg, 100 mg, 150 mg, and placebo). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure.||0.95|0.66|<0.0001
72480273|NCT01037244|144486853|SUPERIORITY_OR_OTHER||Difference in LS Means|16.67|||<|0.0001|TWO_SIDED|95.0|11.23|22.11|||ANOVA|p-values are obtained from ANOVA model with pooled site as a covariate.||540 subjects were randomized with 1:1:1:1 randomization scheme to achieve approximately 135 eligible subjects randomized to each of the 4 treatment groups (WC3043 50 mg, 100 mg, 150 mg, and placebo). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure.||22.11|11.23|<0.0001
72480274|NCT01037244|144486853|SUPERIORITY_OR_OTHER||Difference in LS Means|22.57|||<|0.0001|TWO_SIDED|95.0|17.11|28.03|||ANOVA|p-values are obtained from ANOVA model with pooled site as a covariate.||540 subjects were randomized with 1:1:1:1 randomization scheme to achieve approximately 135 eligible subjects randomized to each of the 4 treatment groups (WC3043 50 mg, 100 mg, 150 mg, and placebo). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure.||28.03|17.11|<0.0001
72480275|NCT01037244|144486853|SUPERIORITY_OR_OTHER||Difference in LS Means|28.39|||<|0.0001|TWO_SIDED|95.0|22.98|33.79|||ANOVA|p-values are obtained from ANOVA model with pooled site as a covariate.||540 subjects were randomized with 1:1:1:1 randomization scheme to achieve approximately 135 eligible subjects randomized to each of the 4 treatment groups (WC3043 50 mg, 100 mg, 150 mg, and placebo). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure.||33.79|22.98|<0.0001
72566654|NCT01421342|144663616|SUPERIORITY||Hazard Ratio (HR)|1.36||||0.7|TWO_SIDED|95.0|0.78|2.39|||Log Rank||Represents relative odds of relapse for Augmentation Antidepressant + Bupropion-SR / Switching to Bupropion-SR|||2.39|0.78|0.70
72566655|NCT01421342|144663616|SUPERIORITY||Hazard Ratio (HR)|1.12||||0.68|TWO_SIDED|95.0|0.65|1.94|||Log Rank||Represents relative odds of relapse for Augmentation Antidepressant + Aripiprazole / Switching to Bupropion-SR|||1.94|0.65|0.68
72566656|NCT01421342|144663616|SUPERIORITY||Hazard Ratio (HR)|0.96||||0.87|TWO_SIDED|95.0|0.58|1.59|||Log Rank||Represents relative odds of relapse for Augmentation Antidepressant + Aripiprazole / Augmentation Antidepressant + Bupropion-SR|||1.59|0.58|0.87
72566657|NCT01421342|144663617|SUPERIORITY||Odds Ratio (OR)|1.16||||0.28|TWO_SIDED|95.0|0.89|1.5|||Regression, Logistic|Stratified by participating medical center|Represents relative odds of response for Augmentation Antidepressant + Bupropion / Switching to Bupropion|After ordering results form largest p-value to smallest (Hochberg approach) the comparison of Augmentation Antidepressant + Bupropion with Switching to Bupropion was performed at the 0.05 significance level.||1.50|0.89|0.28
72566658|NCT01421342|144663617|SUPERIORITY||Odds Ratio (OR)|1.74|||<|0.0001|TWO_SIDED|95.0|1.33|2.29|||Regression, Logistic|Stratified by participating medical center (site)|Represents relative odds of response for Augmentation Antidepressant + Aripiprazole / Switching to Bupropion-SR|After ordering results form largest p-value to smallest (Hochberg approach) the comparison of Augmentation Antidepressant + Aripiprazole with Switching to Bupropion-SR was performed at the 0.025 significance level.||2.29|1.33|<0.0001
72566659|NCT01421342|144663617|SUPERIORITY||Odds Ratio (OR)|1.55||||0.002|TWO_SIDED|95.0|1.17|2.05||Following the gate-keeping strategy of the analysis plan, complete the comparison of Augmentation Antidepressant + Aripiprazole with Augmentation Antidepressant + Bupropion-SR at the 0.05 significance level.|Regression, Logistic|Stratified by participating medical center|Represents relative odds of response for Augmentation Antidepressant + Aripiprazole / Augmentation Antidepressant + Bupropion-SR|||2.05|1.17|0.002
72566660|NCT01421342|144663618|SUPERIORITY||Odds Ratio (OR)|1.26||||0.11|TWO_SIDED|95.0|0.95|1.68||After ordering results form largest p-value to smallest (Hochberg approach) the comparison of Augmentation Antidepressant + Bupropion with Switching to Bupropion was performed at the 0.05 significance level.|Regression, Logistic|Stratified by participating medical center|Represents relative odds of response for Augmentation Antidepressant + Bupropion / Switching to Bupropion|||1.68|0.95|0.11
72400701|NCT00975481|144309004|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|52.4189|||<|0.0001|TWO_SIDED|95.0|36.7157|68.1221|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For placebo, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||68.1221|36.7157|<0.0001
72400702|NCT00975481|144309004|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|48.8246|||<|0.0001|TWO_SIDED|95.0|33.0228|64.6264|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For placebo, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||64.6264|33.0228|<0.0001
72400703|NCT00975481|144309004|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|46.5395|||<|0.0001|TWO_SIDED|95.0|30.5968|62.4823|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For placebo, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||62.4823|30.5968|<0.0001
72400704|NCT00975481|144309004|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|57.5565|||<|0.0001|TWO_SIDED|95.0|42.0679|73.0451|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For placebo, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||73.0451|42.0679|<0.0001
72400705|NCT00975481|144309004|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|53.9622|||<|0.0001|TWO_SIDED|95.0|38.3293|69.5952|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For placebo, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||69.5952|38.3293|<0.0001
72400706|NCT00975481|144309004|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|51.6772|||<|0.0001|TWO_SIDED|95.0|35.866|67.4884|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For placebo, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||67.4884|35.8660|<0.0001
72400707|NCT00975481|144309004|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|37.4454||||0.0003|TWO_SIDED|95.0|17.7051|57.1857|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For benzodiazepines, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||57.1857|17.7051|0.0003
72400708|NCT00975481|144309004|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|41.6714|||<|0.0001|TWO_SIDED|95.0|22.2888|61.054|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For benzodiazepines, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||61.0540|22.2888|<0.0001
72400709|NCT00975481|144309004|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.7583||||0.0744|TWO_SIDED|95.0|-37.2956|1.7789|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For benzodiazepines, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||1.7789|-37.2956|0.0744
72400710|NCT00975481|144309004|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.5551||||0.3458|TWO_SIDED|95.0|-29.5573|10.4471|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For benzodiazepines, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||10.4471|-29.5573|0.3458
72400711|NCT00975481|144309004|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.792||||0.9375|TWO_SIDED|95.0|-19.1777|20.7616|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For benzodiazepines, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||20.7616|-19.1777|0.9375
72400712|NCT00975481|144309004|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-55.2037|||<|0.0001|TWO_SIDED|95.0|-74.8113|-35.5961|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For benzodiazepines, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-35.5961|-74.8113|<0.0001
72623906|NCT00023595|144778258|SUPERIORITY|||||||0.6||||||Baseline|Wilcoxon (Mann-Whitney)|||||||0.60
72623907|NCT00023595|144778258|SUPERIORITY|||||||0.14||||||4 months|Wilcoxon (Mann-Whitney)|||||||0.14
72623908|NCT00023595|144778258|SUPERIORITY|||||||0.57||||||12 months|Wilcoxon (Mann-Whitney)|||||||0.57
72623909|NCT00023595|144778258|SUPERIORITY|||||||0.15||||||24 months|Wilcoxon (Mann-Whitney)|||||||0.15
72400713|NCT00975481|144309004|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-47.0005|||<|0.0001|TWO_SIDED|95.0|-67.002|-26.9989|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For benzodiazepines, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-26.9989|-67.0020|<0.0001
72480276|NCT01037244|144486854|SUPERIORITY_OR_OTHER||Difference in LS Means|1.89|||<|0.0001|TWO_SIDED|95.0|1.17|2.61|||ANCOVA|P-values were obtained from ANCOVA model with Baseline domain score and pooled site as covariates.||540 subjects were randomized with 1:1:1:1 randomization scheme to achieve approximately 135 eligible subjects randomized to each of the 4 treatment groups (WC3043 50 mg, 100 mg, 150 mg, and placebo). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure.||2.61|1.17|<0.0001
72480277|NCT01037244|144486854|SUPERIORITY_OR_OTHER||Difference in LS Means|2.27|||<|0.0001|TWO_SIDED|95.0|1.54|2.99|||ANCOVA|P-values are obtained from ANCOVA model with Baseline domain score and pooled site as covariates.||540 subjects were randomized with 1:1:1:1 randomization scheme to achieve approximately 135 eligible subjects randomized to each of the 4 treatment groups (WC3043 50 mg, 100 mg, 150 mg, and placebo). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure.||2.99|1.54|<0.0001
72480278|NCT01037244|144486854|SUPERIORITY_OR_OTHER||Difference in LS Means|3.02|||<|0.0001|TWO_SIDED|95.0|2.3|3.73|||ANCOVA|P-values are obtained from ANCOVA model with Baseline domain score and pooled site as covariates.||540 subjects were randomized with 1:1:1:1 randomization scheme to achieve approximately 135 eligible subjects randomized to each of the 4 treatment groups (WC3043 50 mg, 100 mg, 150 mg, and placebo). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure.||3.73|2.30|<0.0001
72480279|NCT01037244|144486855|SUPERIORITY_OR_OTHER||Difference in LS Means|1.42|||<|0.0001|TWO_SIDED|95.0|0.81|2.03|||ANCOVA|P-values are obtained from ANCOVA model with Baseline domain score and pooled site as covariates.||540 subjects were randomized with 1:1:1:1 randomization scheme to achieve approximately 135 eligible subjects randomized to each of the 4 treatment groups (WC3043 50 mg, 100 mg, 150 mg, and placebo). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure.||2.03|0.81|<0.0001
72480280|NCT01037244|144486855|SUPERIORITY_OR_OTHER||Difference in LS Means|1.65|||<|0.0001|TWO_SIDED|95.0|1.04|2.26|||ANCOVA|P-values are obtained from ANCOVA model with Baseline domain score and pooled site as covariates.||540 subjects were randomized with 1:1:1:1 randomization scheme to achieve approximately 135 eligible subjects randomized to each of the 4 treatment groups (WC3043 50 mg, 100 mg, 150 mg, and placebo). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure.||2.26|1.04|<0.0001
72480281|NCT01037244|144486855|SUPERIORITY_OR_OTHER||Difference in LS Means|1.98|||<|0.0001|TWO_SIDED|95.0|1.37|2.59|||ANCOVA|P-values are obtained from ANCOVA model with baseline domain score and pooled site as covariates.||540 subjects were randomized with 1:1:1:1 randomization scheme to achieve approximately 135 eligible subjects randomized to each of the 4 treatment groups (WC3043 50 mg, 100 mg, 150 mg, and placebo). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure.||2.59|1.37|<0.0001
72400714|NCT00975481|144309004|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-36.6534||||0.0004|TWO_SIDED|95.0|-56.7246|-16.5822|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For benzodiazepines, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-16.5822|-56.7246|0.0004
72400715|NCT00975481|144309004|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-59.4297|||<|0.0001|TWO_SIDED|95.0|-78.5162|-40.3433|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For benzodiazepines, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-40.3433|-78.5162|<0.0001
72400716|NCT00975481|144309004|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-51.2265|||<|0.0001|TWO_SIDED|95.0|-70.8131|-31.6399|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For benzodiazepines, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-31.6399|-70.8131|<0.0001
72480282|NCT01037244|144486856|SUPERIORITY_OR_OTHER||Difference in LS Means|0.57||||0.0019|TWO_SIDED|95.0|0.21|0.93|||ANCOVA|P-values are obtained from ANCOVA model with Baseline domain score and pooled site as covariates.||540 subjects were randomized with 1:1:1:1 randomization scheme to achieve approximately 135 eligible subjects randomized to each of the 4 treatment groups (WC3043 50 mg, 100 mg, 150 mg, and placebo). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure.||0.93|0.21|0.0019
72623910|NCT00023595|144778258|SUPERIORITY|||||||0.84||||||36 months|Wilcoxon (Mann-Whitney)|||||||0.84
72623911|NCT00023595|144778259|SUPERIORITY||||||<|0.0001||||||Hospital costs|Wilcoxon (Mann-Whitney)|||||||<0.0001
72509974|NCT05372575|144550707|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|9.68|||||TWO_SIDED|95.0|6.65|14.08|||||GMR=(GMC of 13vPnC VT- or Sp- Subgroup)/(GMC of non-13vPnC VT- or Sp- Subgroup)|GMR of 13vPnC Cohort/non-13vPnC Cohort in VT- or Sp- Subgroups for Serotype: 19F||14.08|6.65|
72400717|NCT00975481|144309004|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-40.8794||||0.0001|TWO_SIDED|95.0|-60.4726|-21.2862|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For benzodiazepines, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-21.2862|-60.4726|0.0001
72400718|NCT00975481|144309004|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|23.5197||||0.0102|TWO_SIDED|95.0|5.7096|41.3298|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For codeine/morphine, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||41.3298|5.7096|0.0102
72400719|NCT00975481|144309004|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|27.7321||||0.0021|TWO_SIDED|95.0|10.3632|45.1011|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For codeine/morphine, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||45.1011|10.3632|0.0021
72509975|NCT05372575|144550707|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|9.7|||||TWO_SIDED|95.0|6.9|13.64|||||GMR=(GMC of 13vPnC VT- or Sp- Subgroup)/(GMC of non-13vPnC VT- or Sp- Subgroup)|GMR of 13vPnC Cohort/non-13vPnC Cohort in VT- or Sp- Subgroups for Serotype: 23F||13.64|6.90|
72509976|NCT05372575|144550708|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|0.49|||||TWO_SIDED|95.0|0.06|3.91|||||GMR=(GMT of VT+ Subgroup)/(GMT of VT- or Sp- Subgroup)|GMR of VT+ Subgroup/VT- or Sp- Subgroup in 13vPnC Cohort for Serotype: 1||3.91|0.06|
72509977|NCT05372575|144550708|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|0.54|||||TWO_SIDED|95.0|0.1|2.92|||||GMR=(GMT of VT+ Subgroup)/(GMT of VT- or Sp- Subgroup)|GMR of VT+ Subgroup/VT- or Sp- Subgroup in 13vPnC Cohort for Serotype: 3||2.92|0.10|
72509978|NCT05372575|144550708|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|0.45|||||TWO_SIDED|95.0|0.1|2.07|||||GMR=(GMT of VT+ Subgroup)/(GMT of VT- or Sp- Subgroup)|GMR of VT+ Subgroup/VT- or Sp- Subgroup in 13vPnC Cohort for Serotype: 4||2.07|0.10|
72509979|NCT05372575|144550708|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|1.78|||||TWO_SIDED|95.0|0.27|11.75|||||GMR=(GMT of VT+ Subgroup)/(GMT of VT- or Sp- Subgroup)|GMR of VT+ Subgroup/VT- or Sp- Subgroup in 13vPnC Cohort for Serotype: 5||11.75|0.27|
72509980|NCT05372575|144550708|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|0.23|||||TWO_SIDED|95.0|0.03|1.65|||||GMR=(GMT of VT+ Subgroup)/(GMT of VT- or Sp- Subgroup)|GMR of VT+ Subgroup/VT- or Sp- Subgroup in 13vPnC Cohort for Serotype: 6A||1.65|0.03|
72509981|NCT05372575|144550708|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|0.06|||||TWO_SIDED|95.0|0.01|0.44|||||GMR=(GMT of VT+ Subgroup)/(GMT of VT- or Sp- Subgroup)|GMR of VT+ Subgroup/VT- or Sp- Subgroup in 13vPnC Cohort for Serotype: 6B||0.44|0.01|
72509982|NCT05372575|144550708|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|1.21|||||TWO_SIDED|95.0|0.56|2.65|||||GMR=(GMT of VT+ Subgroup)/(GMT of VT- or Sp- Subgroup)|GMR of VT+ Subgroup/VT- or Sp- Subgroup in 13vPnC Cohort for Serotype: 7F||2.65|0.56|
72509983|NCT05372575|144550708|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|0.2|||||TWO_SIDED|95.0|0.03|1.26|||||GMR=(GMT of VT+ Subgroup)/(GMT of VT- or Sp- Subgroup)|GMR of VT+ Subgroup/VT- or Sp- Subgroup in 13vPnC Cohort for Serotype: 9V||1.26|0.03|
72623912|NCT00023595|144778259|SUPERIORITY||||||<|0.0001||||||Physician fees|Wilcoxon (Mann-Whitney)|||||||<0.0001
72623913|NCT00023595|144778259|SUPERIORITY||||||<|0.0001||||||Total index cost|Wilcoxon (Mann-Whitney)|||||||<0.0001
72623914|NCT00023595|144778260|SUPERIORITY|||||||0.006||||||Hospital costs|Wilcoxon (Mann-Whitney)|||||||0.006
72623915|NCT00023595|144778260|SUPERIORITY||||||<|0.0001||||||Physician fees|Wilcoxon (Mann-Whitney)|||||||<0.0001
72400720|NCT00975481|144309004|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.7334||||0.5935|TWO_SIDED|95.0|-22.2807|12.814|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For codeine/morphine, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||12.8140|-22.2807|0.5935
72400721|NCT00975481|144309004|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.5486||||0.6945|TWO_SIDED|95.0|-14.3397|21.437|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For codeine/morphine, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||21.4370|-14.3397|0.6945
72400722|NCT00975481|144309004|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.2936||||0.4177|TWO_SIDED|95.0|-10.4975|25.0847|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For codeine/morphine, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||25.0847|-10.4975|0.4177
72400723|NCT00975481|144309004|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-28.2531||||0.0019|TWO_SIDED|95.0|-45.802|-10.7042|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For codeine/morphine, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-10.7042|-45.8020|0.0019
72400724|NCT00975481|144309004|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.9711||||0.0299|TWO_SIDED|95.0|-37.9541|-1.988|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For codeine/morphine, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-1.9880|-37.9541|0.0299
72400725|NCT00975481|144309004|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.2261||||0.0759|TWO_SIDED|95.0|-34.1785|1.7264|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For codeine/morphine, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||1.7264|-34.1785|0.0759
72566661|NCT01421342|144663618|SUPERIORITY||Odds Ratio (OR)|1.7|||<|0.001|TWO_SIDED|95.0|1.26|2.29|||Regression, Logistic|Stratified by participating medical center|Represents relative odds of response for Augmentation Antidepressant + Aripiprazole / Switching to Bupropion-SR|After ordering results form largest p-value to smallest (Hochberg approach) the comparison of Augmentation Antidepressant + Aripiprazole with Switching to Bupropion-SR was performed at the 0.025 significance level.||2.29|1.26|<0.001
72566662|NCT01421342|144663618|SUPERIORITY||Odds Ratio (OR)|1.37||||0.043|TWO_SIDED|95.0|1.01|1.86||Following the gate-keeping strategy of the analysis plan, complete the comparison of Augmentation Antidepressant + Aripiprazole with Augmentation Antidepressant + Bupropion-SR at the 0.05 significance level.|Regression, Logistic||Represents relative odds of response for Augmentation Antidepressant + Aripiprazole / Augmentation Antidepressant + Bupropion-SR|||1.86|1.01|0.043
72566663|NCT02384941|144663627|SUPERIORITY||Least squares mean difference|-0.36|STANDARD_ERROR_OF_MEAN|0.047|<|0.001|TWO_SIDED|||||Threshold for significance \< 0.05.|MMRM|||||||<0.001
72566664|NCT02384941|144663627|SUPERIORITY||Least squares mean difference|-0.41|STANDARD_ERROR_OF_MEAN|0.047|<|0.001|TWO_SIDED|95.0||||Threshold for significance \< 0.05.|MMRM|||||||< 0.001
72566665|NCT02384941|144663628|SUPERIORITY||Percentage difference|11.8||||0.002|TWO_SIDED|95.0|4.28|19.36||Threshold for significance \< 0.05.|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially in the order the endpoints were reported. The hierarchical testing sequence continued only when previous endpoint of each treatment comparison was statistically significant at 0.05 level.||19.36|4.28|0.002
72400726|NCT00975481|144309004|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-32.4655||||0.0002|TWO_SIDED|95.0|-49.2278|-15.7032|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For codeine/morphine, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-15.7032|-49.2278|0.0002
72566666|NCT02384941|144663628|SUPERIORITY||Percentage difference|21.9|||<|0.001|TWO_SIDED|95.0|14.1|29.64||Threshold for significance \< 0.05.|Cochran-Mantel-Haenszel|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the relevant compared arms).||29.64|14.10|< 0.001
72566667|NCT02384941|144663629|SUPERIORITY||Least squares mean difference|-2.35|STANDARD_ERROR_OF_MEAN|0.256|<|0.001|TWO_SIDED|95.0|-2.85|-1.85||Threshold for significance \< 0.05.|MMRM|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the relevant compared arms).||-1.85|-2.85|< 0.001
72566668|NCT02384941|144663629|SUPERIORITY||Least squares mean difference|-3.45|STANDARD_ERROR_OF_MEAN|0.256|<|0.001|TWO_SIDED|95.0|-3.95|-2.94||Threshold for significance \< 0.05.|MMRM|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the relevant compared arms).||-2.94|-3.95|< 0.001
72566669|NCT02384941|144663630|SUPERIORITY||Least squares mean difference|-1.5|STANDARD_ERROR_OF_MEAN|0.917||0.1|TWO_SIDED|95.0|-3.3|0.3||Threshold for significance \< 0.05.|MMRM|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the relevant compared arms).||0.30|-3.30|0.10
72400727|NCT00975481|144309004|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-24.1835||||0.0069|TWO_SIDED|95.0|-41.5832|-6.7838|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For codeine/morphine, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-6.7838|-41.5832|0.0069
72400728|NCT00975481|144309004|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-20.4385||||0.0222|TWO_SIDED|95.0|-37.8861|-2.991|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For codeine/morphine, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-2.9910|-37.8861|0.0222
72400729|NCT00975481|144309004|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|24.589||||0.0002|TWO_SIDED|95.0|12.0126|37.1654|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For THC, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||37.1654|12.0126|0.0002
72400730|NCT00975481|144309004|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|29.11|||<|0.0001|TWO_SIDED|95.0|16.4903|41.7298|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For THC, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||41.7298|16.4903|<0.0001
72400731|NCT00975481|144309004|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.6428||||0.6809|TWO_SIDED|95.0|-10.0309|15.3165|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For THC, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||15.3165|-10.0309|0.6809
72400732|NCT00975481|144309004|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.3215||||0.6067|TWO_SIDED|95.0|-16.0415|9.3985|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For THC, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||9.3985|-16.0415|0.6067
72400733|NCT00975481|144309004|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.4722||||0.3999|TWO_SIDED|95.0|-7.335|18.2795|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For THC, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||18.2795|-7.3350|0.3999
72400734|NCT00975481|144309004|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-21.9461||||0.0007|TWO_SIDED|95.0|-34.5327|-9.3596|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For THC, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-9.3596|-34.5327|0.0007
72400735|NCT00975481|144309004|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-27.9105|||<|0.0001|TWO_SIDED|95.0|-40.564|-15.257|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For THC, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-15.2570|-40.5640|<0.0001
72400736|NCT00975481|144309004|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.1168||||0.0036|TWO_SIDED|95.0|-31.8907|-6.3428|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For THC, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-6.3428|-31.8907|0.0036
72400737|NCT00975481|144309004|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-26.4672|||<|0.0001|TWO_SIDED|95.0|-38.8298|-14.1046|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For THC, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-14.1046|-38.8298|<0.0001
72400738|NCT00975481|144309004|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-32.4315|||<|0.0001|TWO_SIDED|95.0|-44.925|-19.938|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For THC, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-19.9380|-44.9250|<0.0001
72509984|NCT05372575|144550708|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|0.36|||||TWO_SIDED|95.0|0.08|1.55|||||GMR=(GMT of VT+ Subgroup)/(GMT of VT- or Sp- Subgroup)|GMR of VT+ Subgroup/VT- or Sp- Subgroup in 13vPnC Cohort for Serotype: 14||1.55|0.08|
72623916|NCT00023595|144778260|SUPERIORITY|||||||0.004||||||Total index cost|Wilcoxon (Mann-Whitney)|||||||0.004
72480283|NCT01037244|144486856|SUPERIORITY_OR_OTHER||Difference in LS Means|0.74|||<|0.0001|TWO_SIDED|95.0|0.38|1.1|||ANCOVA|P-values are obtained from ANCOVA model with Baseline domain score and pooled site as covariates.||540 subjects were randomized with 1:1:1:1 randomization scheme to achieve approximately 135 eligible subjects randomized to each of the 4 treatment groups (WC3043 50 mg, 100 mg, 150 mg, and placebo). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure.||1.10|0.38|<0.0001
72480284|NCT01037244|144486856|SUPERIORITY_OR_OTHER||Difference in LS Means|0.85|||<|0.0001|TWO_SIDED|95.0|0.49|1.21|||ANCOVA|P-values are obtained from ANCOVA model with Baseline domain score and pooled site as covariates.||540 subjects were randomized with 1:1:1:1 randomization scheme to achieve approximately 135 eligible subjects randomized to each of the 4 treatment groups (WC3043 50 mg, 100 mg, 150 mg, and placebo). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure.||1.21|0.49|<0.0001
72480285|NCT01037244|144486857|SUPERIORITY_OR_OTHER||Difference in LS Means|1.66|||<|0.0001|TWO_SIDED|95.0|1.13|2.19|||ANCOVA|P-values are obtained from ANCOVA model with Baseline domain score and pooled site as covariates.||540 subjects were randomized with 1:1:1:1 randomization scheme to achieve approximately 135 eligible subjects randomized to each of the 4 treatment groups (WC3043 50 mg, 100 mg, 150 mg, and placebo). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure.||2.19|1.13|<0.0001
72480286|NCT01037244|144486857|SUPERIORITY_OR_OTHER||Difference in LS Means|1.76|||<|0.0001|TWO_SIDED|95.0|1.23|2.29|||ANCOVA|P-values are obtained from ANCOVA model with Baseline domain score and pooled site as covariates.||540 subjects were randomized with 1:1:1:1 randomization scheme to achieve approximately 135 eligible subjects randomized to each of the 4 treatment groups (WC3043 50 mg, 100 mg, 150 mg, and placebo). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure.||2.29|1.23|<0.0001
72480287|NCT01037244|144486857|SUPERIORITY_OR_OTHER||Difference in LS Means|2.56|||<|0.0001|TWO_SIDED|95.0|2.03|3.09|||ANCOVA|P-values are obtained from ANCOVA model with Baseline domain score and pooled site as covariates.||540 subjects were randomized with 1:1:1:1 randomization scheme to achieve approximately 135 eligible subjects randomized to each of the 4 treatment groups (WC3043 50 mg, 100 mg, 150 mg, and placebo). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure.||3.09|2.03|<0.0001
72480288|NCT01037244|144486858|SUPERIORITY_OR_OTHER||Difference in LS Means|12.34|||<|0.0001|TWO_SIDED|95.0|7.29|17.4|||ANCOVA|"P-values are obtained from ANCOVA model with proportion of yes responses during the baseline period and pooled site as covariates."||540 subjects were randomized with 1:1:1:1 randomization scheme to achieve approximately 135 eligible subjects randomized to each of the 4 treatment groups (WC3043 50 mg, 100 mg, 150 mg, and placebo). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure.||17.40|7.29|<0.0001
72480289|NCT01037244|144486858|SUPERIORITY_OR_OTHER||Difference in LS Means|19.29|||<|0.0001|TWO_SIDED|95.0|14.23|24.36|||ANCOVA|"P-values are obtained from ANCOVA model with proportion of yes responses during the baseline period and pooled site as covariates."||540 subjects were randomized with 1:1:1:1 randomization scheme to achieve approximately 135 eligible subjects randomized to each of the 4 treatment groups (WC3043 50 mg, 100 mg, 150 mg, and placebo). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure.||24.36|14.23|<0.0001
72480290|NCT01037244|144486858|SUPERIORITY_OR_OTHER||Difference in LS Means|19.16|||<|0.0001|TWO_SIDED|95.0|14.14|24.18|||ANCOVA|"P-values are obtained from ANCOVA model with proportion of yes responses during the baseline period and pooled sites as covariates."||540 subjects were randomized with 1:1:1:1 randomization scheme to achieve approximately 135 eligible subjects randomized to each of the 4 treatment groups (WC3043 50 mg, 100 mg, 150 mg, and placebo). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure.||24.18|14.14|<0.0001
72509985|NCT05372575|144550708|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|0.82|||||TWO_SIDED|95.0|0.15|4.47|||||GMR=(GMT of VT+ Subgroup)/(GMT of VT- or Sp- Subgroup)|GMR of VT+ Subgroup/VT- or Sp- Subgroup in 13vPnC Cohort for Serotype: 18C||4.47|0.15|
72509986|NCT05372575|144550708|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|1.35|||||TWO_SIDED|95.0|0.19|9.44|||||GMR=(GMT of VT+ Subgroup)/(GMT of VT- or Sp- Subgroup)|GMR of VT+ Subgroup/VT- or Sp- Subgroup in 13vPnC Cohort for Serotype: 19A||9.44|0.19|
72509987|NCT05372575|144550708|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|3.87|||||TWO_SIDED|95.0|0.67|22.42|||||GMR=(GMT of VT+ Subgroup)/(GMT of VT- or Sp- Subgroup)|GMR of VT+ Subgroup/VT- or Sp- Subgroup in 13vPnC Cohort for Serotype: 19F||22.42|0.67|
72566670|NCT02384941|144663630|SUPERIORITY||Least squares mean difference|-3.3|STANDARD_ERROR_OF_MEAN|0.916|<|0.001|TWO_SIDED|95.0|-5.09|-1.5||Threshold for significance \< 0.05.|MMRM|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the relevant compared arms).||-1.50|-5.09|< 0.001
72400739|NCT00975481|144309004|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-23.6378||||0.0003|TWO_SIDED|95.0|-36.2802|-10.9954|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For THC, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-10.9954|-36.2802|0.0003
72400740|NCT00975481|144309004|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.6675||||0.9728|TWO_SIDED|95.0|-39.708|41.043|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For pseudoephedrine, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||41.0430|-39.7080|0.9728
72400741|NCT00975481|144309004|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|42.7977||||0.0246|TWO_SIDED|95.0|6.1059|79.4894|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For pseudoephedrine, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||79.4894|6.1059|0.0246
72400742|NCT00975481|144309004|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.5411||||0.7068|TWO_SIDED|95.0|-33.785|48.8672|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For pseudoephedrine, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||48.8672|-33.7850|0.7068
72400743|NCT00975481|144309004|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.7069||||0.5492|TWO_SIDED|95.0|-26.0358|47.4496|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For pseudoephedrine, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||47.4496|-26.0358|0.5492
72400744|NCT00975481|144309004|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.1248||||0.5899|TWO_SIDED|95.0|-31.3098|53.5595|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For pseudoephedrine, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||53.5595|-31.3098|0.5899
72400745|NCT00975481|144309004|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.8736||||0.6998|TWO_SIDED|95.0|-29.8691|43.6163|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For pseudoephedrine, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||43.6163|-29.8691|0.6998
72400746|NCT00975481|144309004|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.0394||||0.6187|TWO_SIDED|95.0|-31.4818|51.5606|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For pseudoephedrine, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||51.5606|-31.4818|0.6187
72400747|NCT00975481|144309004|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.4573||||0.5863|TWO_SIDED|95.0|-29.0355|49.9502|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For pseudoephedrine, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||49.9502|-29.0355|0.5863
72400748|NCT00975481|144309004|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-35.2566||||0.0832|TWO_SIDED|95.0|-75.608|5.0948|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For pseudoephedrine, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||5.0948|-75.6080|0.0832
72623917|NCT05889468|144778261|SUPERIORITY|||||||0.49|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test, a non-parametric test, was used since the empirical distribution of data did not follow the normality assumption.||This was an intention-to-treat analysis.||||0.49
72400749|NCT00975481|144309004|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-32.0907||||0.0827|TWO_SIDED|95.0|-68.7519|4.5704|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For pseudoephedrine, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||4.5704|-68.7519|0.0827
72566671|NCT02384941|144663631|SUPERIORITY||Least squares mean difference|-0.99|STANDARD_ERROR_OF_MEAN|0.26|<|0.001|TWO_SIDED|95.0|-1.5|-0.48||Threshold for significance \< 0.05.|MMRM|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the relevant compared arms).||-0.48|-1.50|< 0.001
72480291|NCT01037244|144486859|SUPERIORITY_OR_OTHER||Difference in LS Means|18.07|||<|0.0001|TWO_SIDED|95.0|10.7|25.43|||ANCOVA|"P-values are obtained from ANCOVA model with proportion of yes responses during the baseline period and pooled site as covariates."||540 subjects were randomized with 1:1:1:1 randomization scheme to achieve approximately 135 eligible subjects randomized to each of the 4 treatment groups (WC3043 50 mg, 100 mg, 150 mg, and placebo). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure.||25.43|10.70|<0.0001
72400750|NCT00975481|144309004|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-31.6728||||0.1386|TWO_SIDED|95.0|-74.5352|11.1895|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For pseudoephedrine, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||11.1895|-74.5352|0.1386
72400751|NCT00975481|144309005|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3637||||0.1691|TWO_SIDED|95.0|-0.1566|0.884|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emax, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||0.8840|-0.1566|0.1691
72400752|NCT00975481|144309005|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.8444||||0.0017|TWO_SIDED|95.0|0.3238|1.365|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emax, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||1.3650|0.3238|0.0017
72400753|NCT00975481|144309005|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2093||||0.4305|TWO_SIDED|95.0|-0.3141|0.7327|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emax, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||0.7327|-0.3141|0.4305
72400754|NCT00975481|144309005|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1206||||0.6517|TWO_SIDED|95.0|-0.4064|0.6476|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emax, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||0.6476|-0.4064|0.6517
72400755|NCT00975481|144309005|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.0374||||0.8892|TWO_SIDED|95.0|-0.5666|0.4919|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emax, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||0.4919|-0.5666|0.8892
72400756|NCT00975481|144309005|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1544||||0.5576|TWO_SIDED|95.0|-0.6737|0.3649|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emax, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||0.3649|-0.6737|0.5576
72509988|NCT05372575|144550708|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|0.27|||||TWO_SIDED|95.0|0.05|1.52|||||GMR=(GMT of VT+ Subgroup)/(GMT of VT- or Sp- Subgroup)|GMR of VT+ Subgroup/VT- or Sp- Subgroup in 13vPnC Cohort for Serotype: 23F||1.52|0.05|
72509989|NCT05372575|144550708|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|0.76|||||TWO_SIDED|95.0|0.19|3.07|||||GMR=(GMT of VT+ Subgroup)/(GMT of VT- or Sp- Subgroup)|GMR of VT+ Subgroup/VT- or Sp- Subgroup in non-13vPnC Cohort for Serotype: 1||3.07|0.19|
72509990|NCT05372575|144550708|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|1.02|||||TWO_SIDED|95.0|0.42|2.46|||||GMR=(GMT of VT+ Subgroup)/(GMT of VT- or Sp- Subgroup)|GMR of VT+ Subgroup/VT- or Sp- Subgroup in non-13vPnC Cohort for Serotype: 3||2.46|0.42|
72509991|NCT05372575|144550708|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|0.44|||||TWO_SIDED|95.0|0.05|3.73|||||GMR=(GMT of VT+ Subgroup)/(GMT of VT- or Sp- Subgroup)|GMR of VT+ Subgroup/VT- or Sp- Subgroup in non-13vPnC Cohort for Serotype: 4||3.73|0.05|
72509992|NCT05372575|144550708|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|0.63|||||TWO_SIDED|95.0|0.15|2.73|||||GMR=(GMT of VT+ Subgroup)/(GMT of VT- or Sp- Subgroup)|GMR of VT+ Subgroup/VT- or Sp- Subgroup in non-13vPnC Cohort for Serotype: 5||2.73|0.15|
72623918|NCT05889468|144778262|SUPERIORITY|||||||0.32|||||||Fisher Exact|||Intention-to-treat analysis||||0.32
72400757|NCT00975481|144309005|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2431||||0.3594|TWO_SIDED|95.0|-0.7658|0.2796|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emax, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||0.2796|-0.7658|0.3594
72400758|NCT00975481|144309005|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4011||||0.1355|TWO_SIDED|95.0|-0.9291|0.127|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emax, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||0.1270|-0.9291|0.1355
72400759|NCT00975481|144309005|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6351||||0.0153|TWO_SIDED|95.0|-1.1466|-0.1236|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emax, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-0.1236|-1.1466|0.0153
72400760|NCT00975481|144309005|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7238||||0.0065|TWO_SIDED|95.0|-1.2418|-0.2059|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emax, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-0.2059|-1.2418|0.0065
72400761|NCT00975481|144309005|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8818||||0.0011|TWO_SIDED|95.0|-1.4042|-0.3594|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emax, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-0.3594|-1.4042|0.0011
72400762|NCT00975481|144309005|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.1614|||<|0.0001|TWO_SIDED|95.0|-2.9373|-1.3856|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emin, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-1.3856|-2.9373|<0.0001
72400763|NCT00975481|144309005|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.0336|||<|0.0001|TWO_SIDED|95.0|-3.8085|-2.2587|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emin, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-2.2587|-3.8085|<0.0001
72400764|NCT00975481|144309005|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2791||||0.4804|TWO_SIDED|95.0|-1.0586|0.5004|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emin, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||0.5004|-1.0586|0.4804
72400765|NCT00975481|144309005|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.024||||0.9519|TWO_SIDED|95.0|-0.7608|0.8087|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emin, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||0.8087|-0.7608|0.9519
72400766|NCT00975481|144309005|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.497||||0.2152|TWO_SIDED|95.0|-1.286|0.2921|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emin, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||0.2921|-1.2860|0.2152
72400767|NCT00975481|144309005|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.8824|||<|0.0001|TWO_SIDED|95.0|1.1094|2.6553|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emin, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||2.6553|1.1094|<0.0001
72509993|NCT05372575|144550708|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|0.88|||||TWO_SIDED|95.0|0.11|6.99|||||GMR=(GMT of VT+ Subgroup)/(GMT of VT- or Sp- Subgroup)|GMR of VT+ Subgroup/VT- or Sp- Subgroup in non-13vPnC Cohort for Serotype: 6A||6.99|0.11|
72400768|NCT00975481|144309005|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.1854|||<|0.0001|TWO_SIDED|95.0|1.407|2.9638|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emin, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||2.9638|1.4070|<0.0001
72623919|NCT05889468|144778264|SUPERIORITY||||||>|0.99|||||||Fisher Exact|||Intention-to-treat analysis||||>0.99
72623920|NCT05889468|144778265|SUPERIORITY||||||>|0.99|||||||Fisher Exact|||Intention-to-treat analysis||||>0.99
72400769|NCT00975481|144309005|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.6645|||<|0.0001|TWO_SIDED|95.0|0.8786|2.4503|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emin, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||2.4503|0.8786|<0.0001
72400770|NCT00975481|144309005|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.7545|||<|0.0001|TWO_SIDED|95.0|1.9912|3.5179|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emin, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||3.5179|1.9912|<0.0001
72400771|NCT00975481|144309005|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.0576|||<|0.0001|TWO_SIDED|95.0|2.2858|3.8294|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emin, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||3.8294|2.2858|<0.0001
72400772|NCT00975481|144309005|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.5366|||<|0.0001|TWO_SIDED|95.0|1.7578|3.3155|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emin, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||3.3155|1.7578|<0.0001
72400773|NCT01895855|144309018|SUPERIORITY|The lower, two sided 95% confidence bound on protective efficacy must be \>/= 30%.|Vaccine Efficacy|90.3|||||ONE_SIDED|95.1|62.7||||||Confidence intervals for the protective vaccine efficacy (PE) estimates were calculated using the method of Farrington and Manning (Farrington 1990).|35 participants were challenged 10 days after receiving PXVX0200. 66 participants were challenged either 10 days or 90 days after receiving placebo.|||62.7|
72400774|NCT01895855|144309019|SUPERIORITY|The lower, two sided 95% confidence bound on protective efficacy must be \>/= 30%.|Vaccine Efficacy|79.5|||||ONE_SIDED|95.1|49.9||||||Confidence intervals for the protective vaccine efficacy (PE) estimates were calculated using the method of Farrington and Manning (Farrington 1990).|33 participants were challenged 90 days after receiving PXVX0200. 66 participants were challenged either 10 days or 90 days after receiving placebo.|||49.9|
72400775|NCT01895855|144309020|SUPERIORITY|||||||0.0073|||||||Wilcoxon (Mann-Whitney)|||35 participants were challenged 10 days after receiving PXVX0200. 66 participants were challenged either 10 days or 90 days after receiving placebo.||||0.0073
72400776|NCT01895855|144309021|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||33 participants were challenge 90 days after receiving PXVX0200. 66 participants were challenged either 10 days or 90 days after receiving placebo.||||<0.0001
72400777|NCT01895855|144309022|SUPERIORITY||Vaccine Efficacy|84.5|||||TWO_SIDED|95.0|67.0|100.0|||||Confidence interval for the protective vaccine efficacy (PE) estimates were calculated using the method of Farrington and Manning (Farrington 1990).|35 participants were challenged 10 days after receiving PXVX0200. 66 participants were challenged either 10 days or 90 days after receiving placebo.||100.0|67.0|
72509994|NCT05372575|144550708|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|1.9|||||TWO_SIDED|95.0|0.29|12.51|||||GMR=(GMT of VT+ Subgroup)/(GMT of VT- or Sp- Subgroup)|GMR of VT+ Subgroup/VT- or Sp- Subgroup in non-13vPnC Cohort for Serotype: 6B||12.51|0.29|
72623921|NCT05468918|144778272|OTHER|||||||0.002|||||||ANOVA|||||||0.002
72623922|NCT05468918|144778273|OTHER|||||||0.023|||||||ANOVA|||||||0.023
72400778|NCT01895855|144309023|SUPERIORITY||Vaccine Efficacy|50.8|||||TWO_SIDED|95.0|33.6|66.8|||||Confidence interval for protective vaccine efficacy (PE) estimates were calculated using the method of Farrington and Manning (Farrington 1990).|33 participants were challenged 90 days after receiving PXVX0200. 66 participants were challenged either 10 days or 90 days after receiving placebo.||66.8|33.6|
72400779|NCT01895855|144309024|SUPERIORITY|||||||0.0025|||||||Fisher Exact|||35 participants were challenged 10 days after receiving PXVX0200. 66 participants were challenged either 10 days or 90 days after receiving placebo.||||0.0025
72400780|NCT01895855|144309025|SUPERIORITY|||||||0.0159|||||||Fisher Exact|||33 participants were challenged 90 days after receiving PXVX0200. 66 participants were challenged either 10 days or 90 days after receiving placebo.||||0.0159
72400781|NCT01895855|144309026|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||35 participants were challenged 10 days after receiving PXVX0200. 66 participants were challenged either 10 days or 90 days after receiving placebo.||||<0.0001
72509995|NCT05372575|144550708|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|2.45|||||TWO_SIDED|95.0|0.34|17.43|||||GMR=(GMT of VT+ Subgroup)/(GMT of VT- or Sp- Subgroup)|GMR of VT+ Subgroup/VT- or Sp- Subgroup in non-13vPnC Cohort for Serotype: 7F||17.43|0.34|
72623923|NCT03900650|144778288|OTHER||Mean Difference (Final Values)|7.32|||<|0.01|TWO_SIDED||||||ANOVA|||||||<.01
72623924|NCT03900650|144778289|OTHER||Mean Difference (Final Values)|0.377||||0.77|TWO_SIDED|||||This p-value tests the effect of the study arms on number of sex events.|ANOVA|||||||.770
72400782|NCT01895855|144309027|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||33 participants were challenged 90 days after receiving PXVX0200. 66 participants were challenged either 10 days or 90 days after receiving placebo.||||<0.0001
72400783|NCT01895855|144309028|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||35 participants were challenged 10 days after receiving PXVX0200. 66 participants were challenged either 10 days or 90 days after receiving placebo.||||<0.0001
72400784|NCT01895855|144309029|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||33 participants were challenged 90 days after receiving PXVX0200. 66 participants were challenged either 10 days or 90 days after receiving placebo.||||<0.0001
72400785|NCT00944450|144309044|NON_INFERIORITY_OR_EQUIVALENCE|Pre-specified equivalence bounds = (0.80, 1.25) for AUC geometric mean ratio (B/A)|Geometric Mean Ratio|1.05||||||90.0|1.02|1.07||||||100 mg MK0431 monohydrate (Phase III/FMI formulation) (B) vs. 100 mg MK0431 anhydrous (Phase IIB formulation) (A)||1.07|1.02|
72400786|NCT00944450|144309045|NON_INFERIORITY_OR_EQUIVALENCE|Pre-specified equivalence bounds = (0.80, 1.25) for Cmax geometric mean ratio (B/A)|Geometric Mean Ratio|1.07||||||90.0|0.94|1.22||||||100 mg MK0431 monohydrate (Phase III/FMI formulation) (B) vs. 100 mg MK0431 anhydrous (Phase IIB formulation) (A)||1.22|0.94|
72400787|NCT01831154|144309063|SUPERIORITY_OR_OTHER|||||||0.512|||||||Chi-squared|Chi-squared value of 1.34 and Cramer's V .190||Cross tabulation with statistical testing with chi-square and Cramer's V was performed on infection to determine if there was any difference in surgical site infections between the interventional groups in 30 day period.||||0.512
72400788|NCT01831154|144309064|SUPERIORITY_OR_OTHER|||||||0.024|||||||ANOVA|||||||0.024
72400789|NCT01831154|144309066|SUPERIORITY_OR_OTHER|||||||0.132|||||||ANOVA|||||||0.132
72400790|NCT01831154|144309067|SUPERIORITY_OR_OTHER|||||||0.908||||||A one way ANOVA was used to determine if participants in the tight glycemic group had shorter intensive care unit (ICU) length of stay (LOS) than participants in the other interventional groups.|ANOVA|||||||0.908
72400791|NCT02448654|144309073|SUPERIORITY|||||||0.18||||||The a priori threshold for statistical significance was p\<0.05.|ANOVA|||||||0.18
72400792|NCT02448654|144309074|SUPERIORITY|||||||0.03||||||The a priori threshold for statistical significance was p\<0.05.|ANOVA|||||||0.03
72400793|NCT02448654|144309075|SUPERIORITY|||||||0.037||||||The a priori threshold for statistical significance was p\<0.05.|ANOVA|||||||0.037
72400794|NCT00651755|144309108|NON_INFERIORITY_OR_EQUIVALENCE|The absence of pharmacokinetic drug interactions can be determined if the 90% CI of the geometric mean AUC ratio between 2 groups is within 0.80 to 1.25.|Ratio Geometric Mean AUC|1.2|||||TWO_SIDED|90.0|1.08|1.33|||90% CI||Ratio Geometric Mean AUC (Area Under Curve) of Analyte,CP, between Aprepitant treatment to control Group.|||1.33|1.08|
72400795|NCT00651755|144309109|NON_INFERIORITY_OR_EQUIVALENCE|The absence of pharmacokinetic drug interactions can be determined if the 90% CI of the geometric mean AUC ratio between 2 groups is within 0.80 to 1.25.|ratio Geometric mean AUC|0.75|STANDARD_DEVIATION|0.29|||TWO_SIDED|95.0|0.65|0.86|||equivalence analysis||The geometric mean AUC ratio is the ratio of geometric mean AUC between aprepitant treatment and the control group|||0.86|0.65|
72400796|NCT00651755|144309110|NON_INFERIORITY_OR_EQUIVALENCE|The absence of pharmacokinetic drug interactions can be determined if the 90% CI of the geometric mean AUC ratio between 2 groups is within 0.80 to 1.25.|Ratio Geometric Mean AUC|0.97|STANDARD_DEVIATION|0.35|||TWO_SIDED|90.0|0.83|1.13|||equivalence analysis|The geometric mean AUC ratio is the ratio of geometric mean AUC between aprepitant treatment to the control group|Ratio Geometric Mean AUC of Analyte, 4-OHCP, between Aprepitant treatment to control Group|||1.13|0.83|
72400797|NCT00651755|144309111|NON_INFERIORITY_OR_EQUIVALENCE|The absence of pharmacokinetic drug interactions can be determined if the 90% CI of the geometric mean AUC ratio between 2 groups is within 0.80 to 1.25.|Ratio Geometric Mean AUC|1.04|STANDARD_DEVIATION|0.68|||TWO_SIDED|90.0|0.82|1.33|||equivalence analysis||Ratio Geometric Mean AUC (Area Under Curve) of Analyte, VC, Between Aprepitant treatment to control Group.|||1.33|0.82|
72400798|NCT00651755|144309112|NON_INFERIORITY_OR_EQUIVALENCE|The absence of pharmacokinetic drug interactions can be determined if the 90% CI of the geometric mean AUC ratio between 2 groups is within 0.80 to 1.25.|Ratio Geometric Mean AUC|1.08|STANDARD_DEVIATION|0.17||||90.0|1.02|1.15|||equivalence analysis||The geometric mean AUC ratio is the ratio of geometric mean AUC between aprepitant treatment and the control group.|||1.15|1.02|
72400799|NCT00651755|144309113|NON_INFERIORITY_OR_EQUIVALENCE|The absence of pharmacokinetic drug interactions can be determined if the 90% CI of the geometric mean AUC ratio between 2 groups is within 0.80 to 1.25.|Ratio Geometric Mean AUC|1.16|STANDARD_DEVIATION|0.47|||TWO_SIDED|90.0|1.01|1.32|||equivalence analysis||Ratio Geometric Mean AUC (Area Under Curve) of Analyte,PL, Between Aprepitant treatment to control Group.|||1.32|1.01|
72400800|NCT03642717|144309119|OTHER||||||<|0.0001||||||Paired t-test was applied comparing the difference in mean of change in Glycosylated hemoglobin (HbA1c) at Last Visit versus at Baseline.|Paired t-test|||||||< 0.0001
72400801|NCT03642717|144309122|OTHER||||||<|0.0001||||||Paired t-test was applied comparing the difference in mean of change in Fasting Plasma Glucose (FPG) at Last Visit versus at Baseline.|Paired t-test|||||||< 0.0001
72400802|NCT03642717|144309123|OTHER||||||<|0.0001||||||Paired t-test was applied comparing the difference in mean of change in body weight at Last Visit versus at Baseline.|Paired t-test|||||||< 0.0001
72400803|NCT03642717|144309124|OTHER|||||||0.0076||||||Paired t-test was applied comparing the difference in mean of change in systolic blood pressure (SBP) at Last Visit versus at Baseline.|Paired t-test|||||||0.0076
72400804|NCT03642717|144309125|OTHER||||||<|0.0001||||||Paired t-test was applied comparing the difference in mean of change in diastolic blood pressure (DBP) at Last Visit versus at Baseline.|Paired t-test|||||||< 0.0001
72400805|NCT00663052|144309138|SUPERIORITY_OR_OTHER||Proportion difference|18.34||||0.0015|TWO_SIDED|95.0|6.8|29.88|||Fisher Exact||Primary endpoint used 95% CI to compare to prespecified target rates for each treatment arm.|With 125 participants/group, estimation was: 1)approximately 90% power to reject null hypothesis- PASI 75 response rate at 24 weeks: 50% in ETN 50 mg QW, assuming true rate is 65% or greater; 2)90% power to reject null hypothesis- PASI 75 response rate at 24 weeks: 60% in 50 mg BIW, assuming true rate is 74% or greater. The 95% CI widths on these are approximately ±8.8%, indicating PASI 75 for ETN 50 mg QW and ETN 50 mg BIW must be at least 58.8% \& 68.8%, respectively to reject null hypotheses.||29.88|6.80|0.0015
72400806|NCT00663052|144309139|SUPERIORITY_OR_OTHER||Proportion difference|3.14||||0.3605|TWO_SIDED|95.0|-3.88|10.16|||Fisher Exact|||Comparison between treatment groups at Week 2||10.16|-3.88|0.3605
72400807|NCT00663052|144309139|SUPERIORITY_OR_OTHER||Proportion difference|17.91||||0.0013|TWO_SIDED|95.0|6.5|29.32|||Fisher Exact|||Comparison between treatment groups at Week 4||29.32|6.50|0.0013
72400808|NCT00663052|144309139|SUPERIORITY_OR_OTHER||Proportion difference|19.6||||0.0011|TWO_SIDED|95.0|7.51|31.7|||Fisher Exact|||Comparison between treatment groups at Week 8||31.70|7.51|0.0011
72400809|NCT00663052|144309139|SUPERIORITY_OR_OTHER||Proportion difference|20.09|||<|0.0001|TWO_SIDED|95.0|9.77|30.4|||Fisher Exact|||Comparison between treatment groups at Week 12||30.40|9.77|<.0001
72400810|NCT00663052|144309139|SUPERIORITY_OR_OTHER||Proportion difference|14.38||||0.001|TWO_SIDED|95.0|5.39|23.37|||Fisher Exact|||Comparison between treatment groups at Week 16||23.37|5.39|0.0010
72400811|NCT00663052|144309139|SUPERIORITY_OR_OTHER||Proportion difference|10.75||||0.0087|TWO_SIDED|95.0|2.35|19.16|||Fisher Exact|||Comparison between treatment groups at Week 20||19.16|2.35|0.0087
72400812|NCT00663052|144309139|SUPERIORITY_OR_OTHER||Proportion difference|11.46||||0.0068|TWO_SIDED|95.0|2.77|20.15|||Fisher Exact|||Comparison between treatment groups at Week 24||20.15|2.77|0.0068
72400813|NCT00663052|144309140|SUPERIORITY_OR_OTHER||Proportion difference|1.5||||0.2435|TWO_SIDED|95.0|-1.31|4.32|||Fisher Exact|||Comparison between treatment groups at Week 2||4.32|-1.31|0.2435
72400814|NCT00663052|144309140|SUPERIORITY_OR_OTHER||Proportion difference|1.64||||0.5929|TWO_SIDED|95.0|-4.4|7.67|||Fisher Exact|||Comparison between treatment groups at Week 4||7.67|-4.40|0.5929
72400815|NCT00663052|144309140|SUPERIORITY_OR_OTHER||Proportion difference|13.44||||0.0156|TWO_SIDED|95.0|2.02|24.86|||Fisher Exact|||Comparison between treatment groups at Week 8||24.86|2.02|0.0156
72400816|NCT00663052|144309140|SUPERIORITY_OR_OTHER||Proportion difference|25.18|||<|0.0001|TWO_SIDED|95.0|12.89|37.47|||Fisher Exact|||Comparison between treatment groups at Week 12||37.47|12.89|<.0001
72400817|NCT00663052|144309140|SUPERIORITY_OR_OTHER||Proportion difference|21.84||||0.0003|TWO_SIDED|95.0|9.82|33.85|||Fisher Exact|||Comparison between treatment groups at Week 16||33.85|9.82|0.0003
72400818|NCT00663052|144309140|SUPERIORITY_OR_OTHER||Proportion difference|19.8||||0.0006|TWO_SIDED|95.0|8.23|31.38|||Fisher Exact|||Comparison between treatment groups at Week 20||31.38|8.23|0.0006
72400819|NCT00663052|144309140|SUPERIORITY_OR_OTHER||Proportion difference|18.34||||0.0015|TWO_SIDED|95.0|6.8|29.88|||Fisher Exact|||Comparison between treatment groups at Week 24||29.88|6.80|0.0015
72400820|NCT00663052|144309141|SUPERIORITY_OR_OTHER||Proportion difference|0.0|||||TWO_SIDED|95.0|-0.74|0.74||The P-value at Week 2 was not applicable as the percentage of participants achieving 90% improvement in PASI in both treatment groups were 0%.|Fisher Exact|||Comparison between treatment groups at Week 2||0.74|-0.74|
72400821|NCT00663052|144309141|SUPERIORITY_OR_OTHER||Proportion difference|0.02||||1|TWO_SIDED|95.0|-2.77|2.81|||Fisher Exact|||Comparison between treatment groups at Week 4||2.81|-2.77|1.0000
72400822|NCT00663052|144309141|SUPERIORITY_OR_OTHER||Proportion difference|3.94||||0.2611|TWO_SIDED|95.0|-3.2|11.07|||Fisher Exact|||Comparison between treatment groups at Week 8||11.07|-3.20|0.2611
72400823|NCT00663052|144309141|SUPERIORITY_OR_OTHER||Proportion difference|18.37||||0.0002|TWO_SIDED|95.0|8.3|28.45|||Fisher Exact|||Comparison between treatment groups at Week 12||28.45|8.30|0.0002
72400824|NCT00663052|144309141|SUPERIORITY_OR_OTHER||Proportion difference|17.31||||0.0031|TWO_SIDED|95.0|5.43|29.19|||Fisher Exact|||Comparison between treatment groups at Week 16||29.19|5.43|0.0031
72400825|NCT00663052|144309141|SUPERIORITY_OR_OTHER||Proportion difference|15.92||||0.0081|TWO_SIDED|95.0|3.8|28.04|||Fisher Exact|||Comparison between treatment groups at Week 20||28.04|3.80|0.0081
72400826|NCT00663052|144309141|SUPERIORITY_OR_OTHER||Proportion difference|16.78||||0.0064|TWO_SIDED|95.0|4.46|29.1|||Fisher Exact|||Comparison between treatment groups at Week 24||29.10|4.46|0.0064
72400827|NCT00663052|144309142|SUPERIORITY_OR_OTHER||Proportion difference|0.0|||||TWO_SIDED|95.0|-0.74|0.74||The P-value at Week 2 was to be calculated by Fisher Exact method but was not estimable as the percentage of participants achieving 100% improvement in PASI in both treatment groups were 0%.||||Comparison between treatment groups at Week 2||0.74|-0.74|
72400828|NCT00663052|144309142|SUPERIORITY_OR_OTHER||Proportion difference|-0.73||||1|TWO_SIDED|95.0|-2.9|1.44|||Fisher Exact|||Comparison between treatment groups at Week 4||1.44|-2.90|1.0000
72400829|NCT00663052|144309142|SUPERIORITY_OR_OTHER||Proportion difference|-1.46||||0.4983|TWO_SIDED|95.0|-4.21|1.29|||Fisher Exact|||Comparison between treatment groups at Week 8||1.29|-4.21|0.4983
72400830|NCT00663052|144309142|SUPERIORITY_OR_OTHER||Proportion difference|1.57||||0.4957|TWO_SIDED|95.0|-3.23|6.37|||Fisher Exact|||Comparison between treatment groups at Week 12||6.37|-3.23|0.4957
72400831|NCT00663052|144309142|SUPERIORITY_OR_OTHER||Proportion difference|3.14||||0.3115|TWO_SIDED|95.0|-3.24|9.52|||Fisher Exact|||Comparison between treatment groups at Week 16||9.52|-3.24|0.3115
72400832|NCT00663052|144309142|SUPERIORITY_OR_OTHER||Proportion difference|6.99||||0.0773|TWO_SIDED|95.0|-1.13|15.1|||Fisher Exact|||Comparison between treatment groups at Week 20||15.10|-1.13|0.0773
72400833|NCT00663052|144309142|SUPERIORITY_OR_OTHER||Proportion difference|5.53||||0.183|TWO_SIDED|95.0|-2.82|13.87|||Fisher Exact|||Comparison between treatment groups at Week 24||13.87|-2.82|0.1830
72400834|NCT00663052|144309143|SUPERIORITY_OR_OTHER||Difference of adjusted mean change|-1.3||||0.0103|TWO_SIDED|95.0|-2.3|-0.3|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 2||-0.3|-2.3|0.0103
72400835|NCT00663052|144309143|SUPERIORITY_OR_OTHER||Difference of adjusted mean change|-1.8||||0.0031|TWO_SIDED|95.0|-3.0|-0.6|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 4||-0.6|-3.0|0.0031
72400836|NCT00663052|144309143|SUPERIORITY_OR_OTHER||Difference of adjusted mean change|-3.0|||<|0.0001|TWO_SIDED|95.0|-4.4|-1.7|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 8||-1.7|-4.4|<0.0001
72400837|NCT00663052|144309143|SUPERIORITY_OR_OTHER||Difference of adjusted mean change|-3.6|||<|0.0001|TWO_SIDED|95.0|-5.0|-2.2|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 12||-2.2|-5.0|<0.0001
72400838|NCT00663052|144309143|SUPERIORITY_OR_OTHER||Difference of adjusted mean change|-2.8|||<|0.0001|TWO_SIDED|95.0|-4.0|-1.5|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 16||-1.5|-4.0|<0.0001
72400839|NCT00663052|144309143|SUPERIORITY_OR_OTHER||Difference of adjusted mean change|-2.1||||0.0012|TWO_SIDED|95.0|-3.3|-0.8|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 20||-0.8|-3.3|0.0012
72400840|NCT00663052|144309143|SUPERIORITY_OR_OTHER||Difference of adjusted mean change|-2.0||||0.0042|TWO_SIDED|95.0|-3.4|-0.7|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 24||-0.7|-3.4|0.0042
72400841|NCT00663052|144309144|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Log Rank|||Comparison of treatment groups for PASI 50. Log rank test used to compare groups; CI based on product-limit method.||||<0.0001
72400842|NCT00663052|144309144|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Log Rank|||Comparison of treatment groups for PASI 75. Log rank test used to compare groups; CI based on product-limit method.||||<0.0001
72400843|NCT00663052|144309144|SUPERIORITY_OR_OTHER|||||||0.0053|TWO_SIDED||||||Log Rank|||Comparison of treatment groups for PASI 90. Log rank test used to compare groups; CI based on product-limit method.||||0.0053
72400844|NCT00663052|144309144|SUPERIORITY_OR_OTHER|||||||0.0432|TWO_SIDED||||||Log Rank|||Comparison of treatment groups for PASI 100. Log rank test used to compare groups; CI based on product-limit method.||||0.0432
72400845|NCT00663052|144309145|SUPERIORITY_OR_OTHER||Proportion difference|0.0|||||TWO_SIDED|95.0|-0.74|0.74|||Fisher Exact|||Comparison between treatment groups at Week 2||0.74|-0.74|
72400846|NCT00663052|144309145|SUPERIORITY_OR_OTHER||Proportion difference|-0.73||||1|TWO_SIDED|95.0|-2.9|1.44|||Fisher Exact|||Comparison between treatment groups at Week 4||1.44|-2.90|1.0000
72400847|NCT00663052|144309145|SUPERIORITY_OR_OTHER||Proportion difference|0.04||||1|TWO_SIDED|95.0|-3.58|3.67|||Fisher Exact|||Comparison between treatment groups at Week 8||3.67|-3.58|1.0000
72400848|NCT00663052|144309145|SUPERIORITY_OR_OTHER||Proportion difference|6.1||||0.0401|TWO_SIDED|95.0|-0.26|12.47|||Fisher Exact|||Comparison between treatment groups at Week 12||12.47|-0.26|0.0401
72400849|NCT00663052|144309145|SUPERIORITY_OR_OTHER||Proportion difference|3.29||||0.4415|TWO_SIDED|95.0|-4.95|11.54|||Fisher Exact|||Comparison between treatment groups at Week 16||11.54|-4.95|0.4415
72400850|NCT00663052|144309145|SUPERIORITY_OR_OTHER||Proportion difference|8.6||||0.0617|TWO_SIDED|95.0|-0.67|17.87|||Fisher Exact|||Comparison between treatment groups at Week 20||17.87|-0.67|0.0617
72400851|NCT00663052|144309145|SUPERIORITY_OR_OTHER||Proportion difference|8.64||||0.072|TWO_SIDED|95.0|-0.96|18.24|||Fisher Exact|||Comparison between treatment groups at Week 24||18.24|-0.96|0.0720
72566672|NCT02384941|144663632|SUPERIORITY||Least squares mean difference|2.5|STANDARD_ERROR_OF_MEAN|0.4|<|0.001|TWO_SIDED|95.0|1.8|3.3||Threshold for significance \< 0.05.|MMRM|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the relevant compared arms).||3.3|1.8|< 0.001
72400852|NCT00663052|144309146|SUPERIORITY_OR_OTHER||Proportion difference|-1.45||||0.6223|TWO_SIDED|95.0|-5.07|2.16|||Fisher Exact|||Comparison between treatment groups at Week 2||2.16|-5.07|0.6223
72400853|NCT00663052|144309146|SUPERIORITY_OR_OTHER||Proportion difference|6.21||||0.1|TWO_SIDED|95.0|-1.56|13.98|||Fisher Exact|||Comparison between treatment groups at Week 4||13.98|-1.56|0.1000
72400854|NCT00663052|144309146|SUPERIORITY_OR_OTHER||Proportion difference|15.59||||0.0037|TWO_SIDED|95.0|4.53|26.65|||Fisher Exact|||Comparison between treatment groups at Week 8||26.65|4.53|0.0037
72400855|NCT00663052|144309146|SUPERIORITY_OR_OTHER||Proportion difference|22.04||||0.0004|TWO_SIDED|95.0|9.75|34.33|||Fisher Exact|||Comparison between treatment groups at Week 12||34.33|9.75|0.0004
72400856|NCT00663052|144309146|SUPERIORITY_OR_OTHER||Proportion difference|13.46||||0.0285|TWO_SIDED|95.0|0.94|25.97|||Fisher Exact|||Comparison between treatment groups at Week 16||25.97|0.94|0.0285
72400857|NCT00663052|144309146|SUPERIORITY_OR_OTHER||Proportion difference|15.05||||0.0139|TWO_SIDED|95.0|2.67|27.43|||Fisher Exact|||Comparison between treatment groups at Week 20||27.43|2.67|0.0139
72400858|NCT00663052|144309146|SUPERIORITY_OR_OTHER||Proportion difference|19.56||||0.0012|TWO_SIDED|95.0|7.38|31.74|||Fisher Exact|||Comparison between treatment groups at Week 24||31.74|7.38|0.0012
72400859|NCT00663052|144309147|SUPERIORITY_OR_OTHER||Proportion difference|5.01||||0.3956|TWO_SIDED|95.0|-6.01|16.03|||Fisher Exact|||Comparison between treatment groups at Week 2||16.03|-6.01|0.3956
72400860|NCT00663052|144309147|SUPERIORITY_OR_OTHER||Proportion difference|8.66||||0.1754|TWO_SIDED|95.0|-3.82|21.14|||Fisher Exact|||Comparison between treatment groups at Week 4||21.14|-3.82|0.1754
72400861|NCT00663052|144309147|SUPERIORITY_OR_OTHER||Proportion difference|13.81||||0.0207|TWO_SIDED|95.0|1.9|25.72|||Fisher Exact|||Comparison between treatment groups at Week 8||25.72|1.90|0.0207
72400862|NCT00663052|144309147|SUPERIORITY_OR_OTHER||Proportion difference|19.38|||<|0.0001|TWO_SIDED|95.0|9.23|29.53|||Fisher Exact|||Comparison between treatment groups at Week 12||29.53|9.23|<0.0001
72400863|NCT00663052|144309147|SUPERIORITY_OR_OTHER||Proportion difference|13.54||||0.0044|TWO_SIDED|95.0|3.79|23.29|||Fisher Exact|||Comparison between treatment groups at Week 16||23.29|3.79|0.0044
72400864|NCT00663052|144309147|SUPERIORITY_OR_OTHER||Proportion difference|10.62||||0.0223|TWO_SIDED|95.0|1.11|20.13|||Fisher Exact|||Comparison between treatment groups at Week 20||20.13|1.11|0.0223
72400865|NCT00663052|144309147|SUPERIORITY_OR_OTHER||Proportion difference|11.37||||0.0133|TWO_SIDED|95.0|1.96|20.78|||Fisher Exact|||Comparison between treatment groups at Week 24||20.78|1.96|0.0133
72400866|NCT00663052|144309148|SUPERIORITY_OR_OTHER|||||||0.0003|TWO_SIDED||||||Log Rank|||Comparison between treatment groups for PGA Clear/Almost Clear (0,1). Log rank test used to compare groups; CI based on product-limit method.||||0.0003
72400867|NCT00663052|144309148|SUPERIORITY_OR_OTHER|||||||0.0022|TWO_SIDED||||||Log Rank|||Comparison between treatment groups for PGA Clear/Almost Clear/Mild (0,1,2). Log rank test used to compare groups; CI based on product-limit method.||||0.0022
72400868|NCT00663052|144309149|SUPERIORITY_OR_OTHER||Difference of adjusted mean change|-0.2||||0.0193|TWO_SIDED|95.0|-0.3|0.0|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 2||-0.0|-0.3|0.0193
72400869|NCT00663052|144309149|SUPERIORITY_OR_OTHER||Difference of adjusted mean change|-0.2||||0.0114|TWO_SIDED|95.0|-0.4|-0.1|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 4||-0.1|-0.4|0.0114
72400870|NCT00663052|144309149|SUPERIORITY_OR_OTHER||Difference of adjusted mean change|-0.3||||0.0006|TWO_SIDED|95.0|-0.5|-0.2|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 8||-0.2|-0.5|0.0006
72400871|NCT00663052|144309149|SUPERIORITY_OR_OTHER||Difference of adjusted mean change|-0.5|||<|0.0001|TWO_SIDED|95.0|-0.7|-0.3|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 12||-0.3|-0.7|<0.0001
72400872|NCT00663052|144309149|SUPERIORITY_OR_OTHER||Difference of adjusted mean change|-0.3||||0.0058|TWO_SIDED|95.0|-0.5|-0.1|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 16||-0.1|-0.5|0.0058
72400873|NCT00663052|144309149|SUPERIORITY_OR_OTHER||Difference of adjusted mean change|-0.4||||0.0018|TWO_SIDED|95.0|-0.6|-0.1|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 20||-0.1|-0.6|0.0018
72400874|NCT00663052|144309149|SUPERIORITY_OR_OTHER||Difference of adjusted mean change|-0.4||||0.0009|TWO_SIDED|95.0|-0.6|-0.2|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 24||-0.2|-0.6|0.0009
72400875|NCT00663052|144309150|SUPERIORITY_OR_OTHER||Difference of adjusted mean change|-0.1||||0.6396|TWO_SIDED|95.0|-0.3|0.2|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 2||0.2|-0.3|0.6396
72400876|NCT00663052|144309150|SUPERIORITY_OR_OTHER||Difference of adjusted mean change|-0.4||||0.0074|TWO_SIDED|95.0|-0.7|-0.1|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 4||-0.1|-0.7|0.0074
72400877|NCT00663052|144309150|SUPERIORITY_OR_OTHER||Difference of adjusted mean change|-0.6||||0.0007|TWO_SIDED|95.0|-0.9|-0.2|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 8||-0.2|-0.9|0.0007
72566673|NCT02384941|144663633|SUPERIORITY||Least squares mean difference|-0.8|STANDARD_ERROR_OF_MEAN|0.14|<|0.001|TWO_SIDED|95.0|-1.0|-0.5||Threshold for significance \< 0.05.|MMRM|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the relevant compared arms).||-0.5|-1.0|< 0.001
72400878|NCT00663052|144309150|SUPERIORITY_OR_OTHER||Difference of adjusted mean change|-0.8|||<|0.0001|TWO_SIDED|95.0|-1.1|-0.5|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 12||-0.5|-1.1|<0.0001
72400879|NCT00663052|144309150|SUPERIORITY_OR_OTHER||Difference of adjusted mean change|-0.5||||0.004|TWO_SIDED|95.0|-0.8|-0.1|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 16||-0.1|-0.8|0.0040
72400880|NCT00663052|144309150|SUPERIORITY_OR_OTHER||Difference of adjusted mean change|-0.6||||0.0004|TWO_SIDED|95.0|-0.9|-0.3|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 20||-0.3|-0.9|0.0004
72400881|NCT00663052|144309150|SUPERIORITY_OR_OTHER||Difference of adjusted mean change|-0.2||||0.1799|TWO_SIDED|95.0|-0.5|-0.1|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 24||-0.1|-0.5|0.1799
72400882|NCT00663052|144309151|SUPERIORITY_OR_OTHER||Difference of adjusted mean change|0.0||||0.7757|TWO_SIDED|95.0|-0.2|0.3|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 2||0.3|-0.2|0.7757
72400883|NCT00663052|144309151|SUPERIORITY_OR_OTHER||Difference of adjusted mean change|-0.2||||0.2112|TWO_SIDED|95.0|-0.4|0.1|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 4||0.1|-0.4|0.2112
72400884|NCT00663052|144309151|SUPERIORITY_OR_OTHER||Difference of adjusted mean change|-0.1||||0.5467|TWO_SIDED|95.0|-0.3|0.2|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 8||0.2|-0.3|0.5467
72400885|NCT00663052|144309151|SUPERIORITY_OR_OTHER||Difference of adjusted mean change|-0.1||||0.3684|TWO_SIDED|95.0|-0.4|0.1|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 12||0.1|-0.4|0.3684
72566674|NCT02990806|144663658|EQUIVALENCE|A test for equivalence was carried out using an asymmetric margin (-12%, 15%) pre-specified in protocol and a two 1-sided test (TOST) analysis with α=0.05 for each 1-sided statistical test.|Percentage difference|3.6|STANDARD_ERROR_OF_MEAN|0.04|||TWO_SIDED|95.0|-4.3|11.5||||||||11.5|-4.3|
72566675|NCT00904748|144663705|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Percent of reference to detect for 2-1 tests and power = 20.0%.|ratio between geometric means|98.68|||||TWO_SIDED|90.0|92.03|105.82|||ANOVA||Estimated value = ratio (% reference).|Ratio between geometric means of Test 1 study treatment (chewable without water) and reference study treatment (coated with water).||105.82|92.03|
72400886|NCT00663052|144309151|SUPERIORITY_OR_OTHER||Difference of adjusted mean change|-0.2||||-0.2046|TWO_SIDED|95.0|-0.4|0.1|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 16||0.1|-0.4|-0.2046
72400887|NCT00663052|144309151|SUPERIORITY_OR_OTHER||Difference of adjusted mean change|-0.2||||0.0649|TWO_SIDED|95.0|-0.5|0.0|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 20||0.0|-0.5|0.0649
72400888|NCT00663052|144309151|SUPERIORITY_OR_OTHER||Difference of adjusted mean change|0.0||||0.8683|TWO_SIDED|95.0|-0.3|0.2|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 24||0.2|-0.3|0.8683
72400889|NCT00663052|144309152|SUPERIORITY_OR_OTHER||Difference of adjusted mean change|0.0||||0.8898|TWO_SIDED|95.0|-0.3|0.2|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 2||0.2|-0.3|0.8898
72400890|NCT00663052|144309152|SUPERIORITY_OR_OTHER||Difference of adjusted mean change|-0.4||||0.009|TWO_SIDED|95.0|-0.7|-0.1|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 4||-0.1|-0.7|0.0090
72400891|NCT00663052|144309152|SUPERIORITY_OR_OTHER||Difference of adjusted mean change|-0.4||||0.0028|TWO_SIDED|95.0|-0.7|-0.2|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 8||-0.2|-0.7|0.0028
72400892|NCT00663052|144309152|SUPERIORITY_OR_OTHER||Difference of adjusted mean change|-0.6||||0.0001|TWO_SIDED|95.0|-0.9|-0.3|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 12||-0.3|-0.9|0.0001
72400893|NCT00663052|144309152|SUPERIORITY_OR_OTHER||Difference of adjusted mean change|-0.6|||<|0.0001|TWO_SIDED|95.0|-0.9|-0.3|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 16||-0.3|-0.9|<0.0001
72400894|NCT00663052|144309152|SUPERIORITY_OR_OTHER||Difference of adjusted mean change|-0.5||||0.0016|TWO_SIDED|95.0|-0.8|-0.2|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 20||-0.2|-0.8|0.0016
72400895|NCT00663052|144309152|SUPERIORITY_OR_OTHER||Difference of adjusted mean change|-0.3||||0.0602|TWO_SIDED|95.0|-0.6|0.0|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 24||0.0|-0.6|0.0602
72400896|NCT00663052|144309155|SUPERIORITY_OR_OTHER||Proportion difference|0.42||||1|TWO_SIDED|95.0|-7.7|8.55|||Fisher Exact|||Comparison between treatment groups at Week 12||8.55|-7.70|1.0000
72400897|NCT00663052|144309155|SUPERIORITY_OR_OTHER||Proportion difference|3.94||||0.4213|TWO_SIDED|95.0|-5.75|13.63|||Fisher Exact|||Comparison between treatment groups at Week 16||13.63|-5.75|0.4213
72400898|NCT00663052|144309155|SUPERIORITY_OR_OTHER||Proportion difference|3.98||||0.4039|TWO_SIDED|95.0|-5.38|13.35|||Fisher Exact|||Comparison between treatment groups at Week 20||13.35|-5.38|0.4039
72400899|NCT00663052|144309155|SUPERIORITY_OR_OTHER||Proportion difference|2.5||||0.6168|TWO_SIDED|95.0|-6.87|11.88|||Fisher Exact|||Comparison between treatment groups at Week 24||11.88|-6.87|0.6168
72400900|NCT00663052|144309156|SUPERIORITY_OR_OTHER||Difference of adjusted mean change|-0.2||||0.862|TWO_SIDED|95.0|-2.8|2.3|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||||2.3|-2.8|0.8620
72400901|NCT00663052|144309157|SUPERIORITY_OR_OTHER||Proportion difference|5.68||||0.3525|TWO_SIDED|95.0|-6.05|17.4|||Fisher Exact|||Comparison between treatment groups at Week 2||17.40|-6.05|0.3525
72400902|NCT00663052|144309157|SUPERIORITY_OR_OTHER||Proportion difference|14.7||||0.0202|TWO_SIDED|95.0|2.19|27.2|||Fisher Exact|||Comparison between treatment groups at Week 4||27.20|2.19|0.0202
72400903|NCT00663052|144309157|SUPERIORITY_OR_OTHER||Proportion difference|14.41||||0.0178|TWO_SIDED|95.0|2.17|26.64|||Fisher Exact|||Comparison between treatment groups at Week 8||26.64|2.17|0.0178
72400904|NCT00663052|144309157|SUPERIORITY_OR_OTHER||Proportion difference|21.52|||<|0.0001|TWO_SIDED|95.0|11.02|32.03|||Fisher Exact|||Comparison between treatment groups at Week 12||32.03|11.02|<0.0001
72400905|NCT00663052|144309157|SUPERIORITY_OR_OTHER||Proportion difference|10.53||||0.0325|TWO_SIDED|95.0|0.43|20.64|||Fisher Exact|||Comparison between treatment groups at Week 16||20.64|0.43|0.0325
72400906|NCT00663052|144309157|SUPERIORITY_OR_OTHER||Proportion difference|12.04||||0.0129|TWO_SIDED|95.0|2.1|21.97|||Fisher Exact|||Comparison between treatment groups at Week 20||21.97|2.10|0.0129
72400907|NCT00663052|144309157|SUPERIORITY_OR_OTHER||Proportion difference|11.28||||0.0209|TWO_SIDED|95.0|1.26|21.3|||Fisher Exact|||Comparison between treatment groups at Week 24||21.30|1.26|0.0209
72400908|NCT00663052|144309158|SUPERIORITY_OR_OTHER||Proportion difference|12.1||||0.0461|TWO_SIDED|95.0|-0.24|24.44|||Fisher Exact|||Comparison between treatment groups at Week 2||24.44|-0.24|0.0461
72509996|NCT05372575|144550708|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|1.43|||||TWO_SIDED|95.0|0.27|7.7|||||GMR=(GMT of VT+ Subgroup)/(GMT of VT- or Sp- Subgroup)|GMR of VT+ Subgroup/VT- or Sp- Subgroup in non-13vPnC Cohort for Serotype: 9V||7.70|0.27|
72509997|NCT05372575|144550708|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|2.3|||||TWO_SIDED|95.0|0.3|17.41|||||GMR=(GMT of VT+ Subgroup)/(GMT of VT- or Sp- Subgroup)|GMR of VT+ Subgroup/VT- or Sp- Subgroup in non-13vPnC Cohort for Serotype: 14||17.41|0.30|
72400909|NCT00663052|144309158|SUPERIORITY_OR_OTHER||Proportion difference|8.83||||0.1314|TWO_SIDED|95.0|-2.44|20.1|||Fisher Exact|||Comparison between treatment groups at Week 4||20.10|-2.44|0.1314
72480292|NCT01037244|144486859|SUPERIORITY_OR_OTHER||Difference in LS Means|23.53|||<|0.0001|TWO_SIDED|95.0|16.12|30.94|||ANCOVA|"P-values are obtained from ANCOVA model with proportion of yes responses during the baseline period and pooled site as covariates."||540 subjects were randomized with 1:1:1:1 randomization scheme to achieve approximately 135 eligible subjects randomized to each of the 4 treatment groups (WC3043 50 mg, 100 mg, 150 mg, and placebo). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure.||30.94|16.12|<0.0001
72480293|NCT01037244|144486859|SUPERIORITY_OR_OTHER||Difference in LS Means|36.25|||<|0.0001|TWO_SIDED|95.0|28.92|43.59|||ANCOVA|"P-values are obtained from ANCOVA model with proportion of yes responses during the baseline period and pooled site as covariates."||540 subjects were randomized with 1:1:1:1 randomization scheme to achieve approximately 135 eligible subjects randomized to each of the 4 treatment groups (WC3043 50 mg, 100 mg, 150 mg, and placebo). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure.||43.59|28.92|<0.0001
72480294|NCT01037244|144486860|SUPERIORITY_OR_OTHER||Difference in LS Means|18.2|||<|0.0001|TWO_SIDED|95.0|10.79|25.6|||ANCOVA|"P-values are obtained from ANCOVA model with proportion of yes responses during the baseline period and pooled site as covariates."||540 subjects were randomized with 1:1:1:1 randomization scheme to achieve approximately 135 eligible subjects randomized to each of the 4 treatment groups (WC3043 50 mg, 100 mg, 150 mg, and placebo). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure.||25.60|10.79|<0.0001
72480295|NCT01037244|144486860|SUPERIORITY_OR_OTHER||Difference in LS Means|25.25|||<|0.0001|TWO_SIDED|95.0|17.82|32.69|||ANCOVA|"P-values are obtained from ANCOVA model with proportion of yes responses during the baseline period and pooled site as covariates."||540 subjects were randomized with 1:1:1:1 randomization scheme to achieve approximately 135 eligible subjects randomized to each of the 4 treatment groups (WC3043 50 mg, 100 mg, 150 mg, and placebo). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure.||32.69|17.82|<0.0001
72480296|NCT01037244|144486860|SUPERIORITY_OR_OTHER||Difference in LS Means|36.99|||<|0.0001|TWO_SIDED|95.0|29.63|44.36|||ANCOVA|"P-values are obtained from ANCOVA model with proportion of yes responses during the baseline period and pooled site as covariates."||540 subjects were randomized with 1:1:1:1 randomization scheme to achieve approximately 135 eligible subjects randomized to each of the 4 treatment groups (WC3043 50 mg, 100 mg, 150 mg, and placebo). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure.||44.36|29.63|<0.0001
72480297|NCT01037244|144486861|SUPERIORITY_OR_OTHER||Difference in LS Means|19.98|||<|0.0001|TWO_SIDED|95.0|12.69|27.26|||ANCOVA|"P-values are obtained from ANCOVA model with proportion of yes responses during the baseline period and pooled site as covariates."||540 subjects were randomized with 1:1:1:1 randomization scheme to achieve approximately 135 eligible subjects randomized to each of the 4 treatment groups (WC3043 50 mg, 100 mg, 150 mg, and placebo). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure.||27.26|12.69|<0.0001
72480298|NCT01037244|144486861|SUPERIORITY_OR_OTHER||Difference in LS Means|27.58|||<|0.0001|TWO_SIDED|95.0|20.29|34.88|||ANCOVA|"P-values are obtained from ANCOVA model with proportion of yes responses during the baseline period and pooled site as covariates."||540 subjects were randomized with 1:1:1:1 randomization scheme to achieve approximately 135 eligible subjects randomized to each of the 4 treatment groups (WC3043 50 mg, 100 mg, 150 mg, and placebo). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure.||34.88|20.29|<0.0001
72480299|NCT01037244|144486861|SUPERIORITY_OR_OTHER||Difference in LS Means|37.8|||<|0.0001|TWO_SIDED|95.0|30.57|45.03|||ANCOVA|"P-values are obtained from ANCOVA model with proportion of yes responses during the baseline period and pooled site as covariates."||540 subjects were randomized with 1:1:1:1 randomization scheme to achieve approximately 135 eligible subjects randomized to each of the 4 treatment groups (WC3043 50 mg, 100 mg, 150 mg, and placebo). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure.||45.03|30.57|<0.0001
72480300|NCT00690820|144486862|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA|||The parameter was analyzed using an analysis of variance (ANOVA) including treatment, sequence and period as fixed effect and subject within sequence as a random effect.||||<0.001
72480301|NCT00690820|144486863|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA|||The parameter was analyzed using an analysis of variance (ANOVA) including treatment, sequence and period as fixed effect and subject within sequence as a random effect.||||<0.001
72480302|NCT00690820|144486864|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA|||The parameter was analyzed using an analysis of variance (ANOVA) including treatment, sequence and period as fixed effect and subject within sequence as a random effect.||||<0.001
72480303|NCT00690820|144486865|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA|||The parameter was analyzed using an analysis of variance (ANOVA) including treatment, sequence and period as fixed effect and subject within sequence as a random effect.||||<0.001
72400910|NCT00663052|144309158|SUPERIORITY_OR_OTHER||Proportion difference|11.2||||0.0289|TWO_SIDED|95.0|0.65|21.74|||Fisher Exact|||Comparison between treatment groups at Week 8||21.74|0.65|0.0289
72509998|NCT05372575|144550708|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|0.65|||||TWO_SIDED|95.0|0.14|2.97|||||GMR=(GMT of VT+ Subgroup)/(GMT of VT- or Sp- Subgroup)|GMR of VT+ Subgroup/VT- or Sp- Subgroup in non-13vPnC Cohort for Serotype: 18C||2.97|0.14|
72509999|NCT05372575|144550708|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|1.51|||||TWO_SIDED|95.0|0.28|8.21|||||GMR=(GMT of VT+ Subgroup)/(GMT of VT- or Sp- Subgroup)|GMR of VT+ Subgroup/VT- or Sp- Subgroup in non-13vPnC Cohort for Serotype: 19A||8.21|0.28|
72510000|NCT05372575|144550708|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|0.63|||||TWO_SIDED|95.0|0.13|2.97|||||GMR=(GMT of VT+ Subgroup)/(GMT of VT- or Sp- Subgroup)|GMR of VT+ Subgroup/VT- or Sp- Subgroup in non-13vPnC Cohort for Serotype: 19F||2.97|0.13|
72510001|NCT05372575|144550708|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|1.23|||||TWO_SIDED|95.0|0.15|10.24|||||GMR=(GMT of VT+ Subgroup)/(GMT of VT- or Sp- Subgroup)|GMR of VT+ Subgroup/VT- or Sp- Subgroup in non-13vPnC Cohort for Serotype: 23F||10.24|0.15|
72510002|NCT05372575|144550708|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|3.15|||||TWO_SIDED|95.0|0.41|23.91|||||GMR=(GMT of 13vPnC VT+ Subgroup)/(GMT of non-13vPnC VT+ Subgroup)|GMR of 13vPnC Cohort/non-13vPnC Cohort in VT+ Subgroups for Serotype: 1||23.91|0.41|
72510003|NCT05372575|144550708|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|5.02|||||TWO_SIDED|95.0|1.45|17.39|||||GMR=(GMT of 13vPnC VT+ Subgroup)/(GMT of non-13vPnC VT+ Subgroup)|GMR of 13vPnC Cohort/non-13vPnC Cohort in VT+ Subgroups for Serotype: 3||17.39|1.45|
72510004|NCT05372575|144550708|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|13.7|||||TWO_SIDED|95.0|1.32|141.81|||||GMR=(GMT of 13vPnC VT+ Subgroup)/(GMT of non-13vPnC VT+ Subgroup)|GMR of 13vPnC Cohort/non-13vPnC Cohort in VT+ Subgroups for Serotype: 4||141.81|1.32|
72510005|NCT05372575|144550708|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|48.41|||||TWO_SIDED|95.0|6.16|380.54|||||GMR=(GMT of 13vPnC VT+ Subgroup)/(GMT of non-13vPnC VT+ Subgroup)|GMR of 13vPnC Cohort/non-13vPnC Cohort in VT+ Subgroups for Serotype: 5||380.54|6.16|
72510006|NCT05372575|144550708|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|10.47|||||TWO_SIDED|95.0|0.48|229.1|||||GMR=(GMT of 13vPnC VT+ Subgroup)/(GMT of non-13vPnC VT+ Subgroup)|GMR of 13vPnC Cohort/non-13vPnC Cohort in VT+ Subgroups for Serotype: 6A||229.10|0.48|
72510007|NCT05372575|144550708|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|0.68|||||TWO_SIDED|95.0|0.02|19.83|||||GMR=(GMT of 13vPnC VT+ Subgroup)/(GMT of non-13vPnC VT+ Subgroup)|GMR of 13vPnC Cohort/non-13vPnC Cohort in VT+ Subgroups for Serotype: 6B||19.83|0.02|
72510008|NCT05372575|144550708|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|10.53|||||TWO_SIDED|95.0|1.98|55.96|||||GMR=(GMT of 13vPnC VT+ Subgroup)/(GMT of non-13vPnC VT+ Subgroup)|GMR of 13vPnC Cohort/non-13vPnC Cohort in VT+ Subgroups for Serotype: 7F||55.96|1.98|
72510009|NCT05372575|144550708|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|3.32|||||TWO_SIDED|95.0|0.19|56.82|||||GMR=(GMT of 13vPnC VT+ Subgroup)/(GMT of non-13vPnC VT+ Subgroup)|GMR of 13vPnC Cohort/non-13vPnC Cohort in VT+ Subgroups for Serotype: 9V||56.82|0.19|
72510010|NCT05372575|144550708|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|2.0|||||TWO_SIDED|95.0|0.06|63.12|||||GMR=(GMT of 13vPnC VT+ Subgroup)/(GMT of non-13vPnC VT+ Subgroup)|GMR of 13vPnC Cohort/non-13vPnC Cohort in VT+ Subgroups for Serotype: 14||63.12|0.06|
72510011|NCT05372575|144550708|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|16.31|||||TWO_SIDED|95.0|2.15|123.48|||||GMR=(GMT of 13vPnC VT+ Subgroup)/(GMT of non-13vPnC VT+ Subgroup)|GMR of 13vPnC Cohort/non-13vPnC Cohort in VT+ Subgroups for Serotype: 18C||123.48|2.15|
72480304|NCT00690820|144486866|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA|||The parameter was analyzed using an analysis of variance (ANOVA) including treatment, sequence and period as fixed effect and subject within sequence as a random effect.||||<0.001
72480305|NCT00690820|144486867|SUPERIORITY_OR_OTHER|||||||0.671||95.0|||||ANOVA|||The parameter was analyzed using an analysis of variance (ANOVA) including treatment, sequence and period as fixed effect and subject within sequence as a random effect.||||0.671
72480306|NCT00690820|144486868|SUPERIORITY_OR_OTHER|||||||0.003||95.0|||||ANOVA|||The parameter was analyzed using an analysis of variance (ANOVA) including treatment, sequence and period as fixed effect and subject within sequence as a random effect.||||0.003
72480307|NCT00690820|144486869|SUPERIORITY_OR_OTHER|||||||0.023||95.0|||||ANOVA|||The parameter was analyzed using an analysis of variance (ANOVA) including treatment, sequence and period as fixed effect and subject within sequence as a random effect.||||0.023
72480308|NCT01249274|144486881|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.19||||0.01|TWO_SIDED|95.0|1.04|1.36|||Generalized Estimating Equation|Negative binomial distribution, log link, and first-order autoregressive covariance structure|Estimated value is the risk ratio estimate for the treatment x time interaction term. Time was treated as a continuous variable and progesterone was the reference group for the treatment variable.|||1.36|1.04|0.010
72480309|NCT01249274|144486882|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|30.39||||0.003|TWO_SIDED|95.0|3.18|290.04|||Generalized Estimating Equation|Negative binomial distribution, log link, and first-order autoregressive covariance structure|Estimated value is RR for treatment\*time interaction for placebo at 3-mo post-trial follow-up. Time treated as a 3-level categorical variable; week 0 (ref), week 12 \& 3-month post-trial follow-up. Treatment variable reference group was progesterone.|We calculated that a sample size of 50 women would have 80% power to detect a significant (p\<0.05) difference between groups if the effect size for the primary outcome was large.||290.04|3.18|0.003
72480310|NCT01249274|144486882|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|16.65||||0.038|TWO_SIDED|95.0|1.18|235.52|||Generalized Estimating Equation||Estimated value is RR for treatment\*time interaction term for placebo at week 12. Time was treated as a 3-level categorical variable; week 0 (ref), week 12 and 3-month post-trial follow-up. Treatment variable reference group was progesterone.|Negative binomial distribution, log link, and first-order autoregressive covariance structure||235.52|1.18|0.038
72400911|NCT00663052|144309158|SUPERIORITY_OR_OTHER||Proportion difference|8.52||||0.0433|TWO_SIDED|95.0|-0.04|17.07|||Fisher Exact|||Comparison between treatment groups at Week 12||17.07|-0.04|0.0433
72400912|NCT00663052|144309158|SUPERIORITY_OR_OTHER||Proportion difference|7.06||||0.0902|TWO_SIDED|95.0|-1.32|15.43|||Fisher Exact|||Comparison between treatment groups at Week 16||15.43|-1.32|0.0902
72400913|NCT00663052|144309158|SUPERIORITY_OR_OTHER||Proportion difference|7.79||||0.063|TWO_SIDED|95.0|-0.68|16.26|||Fisher Exact|||Comparison between treatment groups at Week 20||16.26|-0.68|0.0630
72400914|NCT00663052|144309158|SUPERIORITY_OR_OTHER||Proportion difference|7.7||||0.0907|TWO_SIDED|95.0|-1.53|16.93|||Fisher Exact|||Comparison between treatment groups at Week 24||16.93|-1.53|0.0907
72400915|NCT00663052|144309161|SUPERIORITY_OR_OTHER||Proportion difference|3.25||||0.6255|TWO_SIDED|95.0|-9.39|15.9|||Fisher Exact|||Comparison between treatment groups at Week 2||15.90|-9.39|0.6255
72400916|NCT00663052|144309161|SUPERIORITY_OR_OTHER||Proportion difference|9.3||||0.1292|TWO_SIDED|95.0|-2.85|21.45|||Fisher Exact|||Comparison between treatment groups at Week 4||21.45|-2.85|0.1292
72480311|NCT01249274|144486883|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.0||||0.99|TWO_SIDED|95.0|0.87|1.15|||Generalized Estimating Equation||Estimated value is the risk ratio for the treatment x time interaction term. Time was treated as a continuous variable and progesterone was the reference group for treatment.|We calculated that a sample size of 50 women would have 80% power to detect a significant (p\<0.05) difference between groups if the effect size for the primary outcome was large.||1.15|0.87|0.99
72480312|NCT01249274|144486884|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.34||||0.75|TWO_SIDED|95.0|0.23|7.88|||Generalized Estimating Equation||Estimated value is RR for treatment\*time interaction for placebo at 3-mo post-trial follow-up. Time treated as a 3-level categorical variable; week 0 (ref), week 12 \& 3-month post-trial follow-up. Treatment variable reference group was progesterone.|We calculated that a sample size of 50 women would have 80% power to detect a significant (p\<0.05) difference between groups if the effect size for the primary outcome was large.||7.88|0.23|0.75
72480313|NCT01249274|144486884|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.18||||0.84|TWO_SIDED|95.0|0.24|5.84|||Generalized Estimating Equation|Negative binomial distribution, log link, and first-order autoregressive covariance structure|Estimated value is RR for treatment\*time interaction for placebo at week 12. Time was treated as a 3-level categorical variable; week 0 (ref), week 12 \& 3-month post-trial follow-up. Treatment variable reference group was progesterone.|||5.84|0.24|0.84
72480314|NCT01249274|144486885|SUPERIORITY_OR_OTHER|||||||0.103|TWO_SIDED||||||Fisher Exact|||||||0.1030
72510012|NCT05372575|144550708|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|24.16|||||TWO_SIDED|95.0|1.59|367.81|||||GMR=(GMT of 13vPnC VT+ Subgroup)/(GMT of non-13vPnC VT+ Subgroup)|GMR of 13vPnC Cohort/non-13vPnC Cohort in VT+ Subgroups for Serotype: 19A||367.81|1.59|
72510013|NCT05372575|144550708|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|95.06|||||TWO_SIDED|95.0|13.08|691.01|||||GMR=(GMT of 13vPnC VT+ Subgroup)/(GMT of non-13vPnC VT+ Subgroup)|GMR of 13vPnC Cohort/non-13vPnC Cohort in VT+ Subgroups for Serotype: 19F||691.01|13.08|
72510014|NCT05372575|144550708|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|10.49|||||TWO_SIDED|95.0|0.64|171.84|||||GMR=(GMT of 13vPnC VT+ Subgroup)/(GMT of non-13vPnC VT+ Subgroup)|GMR of 13vPnC Cohort/non-13vPnC Cohort in VT+ Subgroups for Serotype: 23F||171.84|0.64|
72400917|NCT00663052|144309161|SUPERIORITY_OR_OTHER||Proportion difference|11.86||||0.0251|TWO_SIDED|95.0|0.94|22.78|||Fisher Exact|||Comparison between treatment groups at Week 8||22.78|0.94|0.0251
72400918|NCT00663052|144309161|SUPERIORITY_OR_OTHER||Proportion difference|14.16||||0.0055|TWO_SIDED|95.0|3.68|24.64|||Fisher Exact|||Comparison between treatment groups at Week 12||24.64|3.68|0.0055
72400919|NCT00663052|144309161|SUPERIORITY_OR_OTHER||Proportion difference|11.99||||0.0159|TWO_SIDED|95.0|1.78|22.2|||Fisher Exact|||Comparison between treatment groups at Week 16||22.20|1.78|0.0159
72400920|NCT00663052|144309161|SUPERIORITY_OR_OTHER||Proportion difference|9.05||||0.0672|TWO_SIDED|95.0|-1.08|19.18|||Fisher Exact|||Comparison between treatment groups at Week 20||19.18|-1.08|0.0672
72400921|NCT00663052|144309161|SUPERIORITY_OR_OTHER||Proportion difference|10.51||||0.0351|TWO_SIDED|95.0|0.27|20.75|||Fisher Exact|||Comparison between treatment groups at Week 24||20.75|0.27|0.0351
72566676|NCT00904748|144663705|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Percent of reference to detect for 2-1 tests and power = 20.0%.|ratio between geometric means|97.23|||||TWO_SIDED|90.0|90.67|104.26|||ANOVA||Estimated value = ratio (% reference).|Ratio between geometric means of Test 2 study treatment (chewable with water) and reference study treatment (coated with water).||104.26|90.67|
72566677|NCT00904748|144663706|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Percent of reference to detect for 2-1 tests and power = 20%.|ratio between geometric means|80.83|||||TWO_SIDED|90.0|72.38|90.26|||ANOVA||Estimated value = ratio (% reference).|Ratio between geometric means of Test 1 study treatment (chewable without water) and reference study treatment (coated with water).||90.26|72.38|
72566678|NCT00904748|144663706|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Percent of reference to detect for 2-1 tests and power = 20%.|ratio between geometric means|78.76|||||TWO_SIDED|90.0|70.53|87.96|||ANOVA||Estimated value = ratio (% reference).|Ratio between geometric means of Test 2 study treatment (chewable with water) and reference study treatment (coated with water).||87.96|70.53|
72566679|NCT00904748|144663707|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Percent of reference to detect for 2-1 tests and power = 20.0%.|ratio between geometric means|99.12|||||TWO_SIDED|90.0|92.76|105.93|||ANOVA||Estimated value = ratio (% reference).|Ratio between geometric means of Test 1 study treatment (chewable without water) and reference study treatment (coated with water).||105.93|92.76|
72566680|NCT00904748|144663707|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Percent of reference to detect for 2-1 tests and power = 20.0%.|ratio between geometric means|97.84|||||TWO_SIDED|90.0|91.56|104.56|||ANOVA||Estimated value = ratio (% reference).|Ratio between geometric means of Test 2 study treatment (chewable with water) and reference study treatment (coated with water).||104.56|91.56|
72566681|NCT00904748|144663708|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.18|||||TWO_SIDED|90.0|-0.14|0.5|||ANOVA|||Difference in Tmax between Test 1 study treatment (chewable without water) and reference study treatment (coated with water).||0.50|-0.14|
72566682|NCT00904748|144663708|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.01|||||TWO_SIDED|90.0|-0.27|0.28|||ANOVA|||Difference in Tmax between Test 2 study treatment (chewable with water) and reference study treatment (coated with water).||0.28|-0.27|
72566683|NCT00700817|144663783|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority concluded if upper confidence interval of test was below 0.4%. Superiority concluded if upper limit of confidence interval was below 0%.|Estimated treatment difference, LS Mean|-0.6||||0.0001||95.0|-0.77|-0.43||Multiple comparisons not applicable due to the hieracheal testing.|ANCOVA|Adjusted for treatment and country (fixed effects) and baseline HbA1c (covariate).||ANCOVA with treatment and country as fixed effects and baseline HbA1c as covariate. Hieracheal testing of non-inferiority followed by superiority.||-0.43|-0.77|0.0001
72566684|NCT00700817|144663783|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority concluded if upper confidence interval of test was below 0.4%. Superiority concluded if upper limit of confidence interval was below 0%.|Estimated treatment difference, LS Mean|-0.34||||0.0001||95.0|-0.51|-0.16||Multiple comparisons not applicable due to the hieracheal testing.|ANCOVA|Adjusted for treatment and country (fixed effects) and baseline HbA1c (covariate).||ANCOVA with treatment and country as fixed effects and baseline HbA1c as covariate. Hieracheal testing of non-inferiority followed by superiority. Liraglutide 1.2 mg versus sitagliptin only tested if liraglutide 1.8 mg was superior to sitagliptin.||-0.16|-0.51|0.0001
72400922|NCT00663052|144309162|SUPERIORITY_OR_OTHER||Proportion difference|6.24||||0.2283|TWO_SIDED|95.0|-4.11|16.58|||Fisher Exact|||Comparison between treatment groups at Week 2||16.58|-4.11|0.2283
72400923|NCT00663052|144309162|SUPERIORITY_OR_OTHER||Proportion difference|5.49||||0.2326|TWO_SIDED|95.0|-3.68|14.66|||Fisher Exact|||Comparison between treatment groups at Week 4||14.66|-3.68|0.2326
72400924|NCT00663052|144309162|SUPERIORITY_OR_OTHER||Proportion difference|10.0||||0.0165|TWO_SIDED|95.0|1.47|18.52|||Fisher Exact|||Comparison between treatment groups at Week 8||18.52|1.47|0.0165
72400925|NCT00663052|144309162|SUPERIORITY_OR_OTHER||Proportion difference|10.0||||0.0165|TWO_SIDED|95.0|1.47|18.52|||Fisher Exact|||Comparison between treatment groups at Week 12||18.52|1.47|0.0165
72400926|NCT00663052|144309162|SUPERIORITY_OR_OTHER||Proportion difference|4.85||||0.2536|TWO_SIDED|95.0|-3.46|13.15|||Fisher Exact|||Comparison between treatment groups at Week 16||13.15|-3.46|0.2536
72400927|NCT00663052|144309162|SUPERIORITY_OR_OTHER||Proportion difference|5.6||||0.1761|TWO_SIDED|95.0|-2.59|13.78|||Fisher Exact|||Comparison between treatment groups at Week 20||13.78|-2.59|0.1761
72400928|NCT00663052|144309162|SUPERIORITY_OR_OTHER||Proportion difference|4.01||||0.3943|TWO_SIDED|95.0|-5.18|13.2|||Fisher Exact|||Comparison between treatment groups at Week 24||13.20|-5.18|0.3943
72400929|NCT00663052|144309163|SUPERIORITY_OR_OTHER||Difference of adjusted mean change|-0.3||||0.5748|TWO_SIDED|95.0|-1.5|0.8|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 2||0.8|-1.5|0.5748
72400930|NCT00663052|144309163|SUPERIORITY_OR_OTHER||Difference of adjusted mean change|-1.2||||0.0471|TWO_SIDED|95.0|-2.4|0.0|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 4||-0.0|-2.4|0.0471
72400931|NCT00663052|144309163|SUPERIORITY_OR_OTHER||Difference of adjusted mean change|-2.0||||0.0025|TWO_SIDED|95.0|-3.3|-0.7|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 8||-0.7|-3.3|0.0025
72400932|NCT00663052|144309163|SUPERIORITY_OR_OTHER||Difference of adjusted mean change|-2.2||||0.0009|TWO_SIDED|95.0|-3.5|-0.9|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 12||-0.9|-3.5|0.0009
72400933|NCT00663052|144309163|SUPERIORITY_OR_OTHER||Difference of adjusted mean change|-1.9||||0.0015|TWO_SIDED|95.0|-3.1|-0.7|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 16||-0.7|-3.1|0.0015
72400934|NCT00663052|144309163|SUPERIORITY_OR_OTHER||Difference of adjusted mean change|-1.5||||0.0197|TWO_SIDED|95.0|-2.7|-0.2|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 20||-0.2|-2.7|0.0197
72400935|NCT00663052|144309163|SUPERIORITY_OR_OTHER||Difference of adjusted mean change|-1.3||||0.0506|TWO_SIDED|95.0|-2.6|0.0|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 24||0.0|-2.6|0.0506
72400936|NCT00663052|144309164|SUPERIORITY_OR_OTHER||Difference of adjusted mean change|0.04||||0.0435|TWO_SIDED|95.0|0.0|0.09|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 12||0.09|0.00|0.0435
72400937|NCT00663052|144309164|SUPERIORITY_OR_OTHER||Difference of adjusted mean change|0.05||||0.0275|TWO_SIDED|95.0|0.01|0.1|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 24||0.10|0.01|0.0275
72400938|NCT00663052|144309165|SUPERIORITY_OR_OTHER||Difference of adjusted mean change|0.0||||0.9473|TWO_SIDED|95.0|-0.7|0.7|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 12||0.7|-0.7|0.9473
72400939|NCT00663052|144309165|SUPERIORITY_OR_OTHER||Difference of adjusted mean change|-0.1||||0.8217|TWO_SIDED|95.0|-0.8|0.6|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 24||0.6|-0.8|0.8217
72400940|NCT00663052|144309166|SUPERIORITY_OR_OTHER||Difference of Adjusted Mean Change|-0.7||||0.0539|TWO_SIDED|95.0|-1.4|0.0|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 12||0.0|-1.4|0.0539
72400941|NCT00663052|144309166|SUPERIORITY_OR_OTHER||Difference of Adjusted Mean Change|-0.5||||0.1494|TWO_SIDED|95.0|-1.3|0.2|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 24||0.2|-1.3|0.1494
72400942|NCT00663052|144309172|SUPERIORITY_OR_OTHER|||||||0.2139|TWO_SIDED||||||Fisher Exact|||Comparison between treatment groups at Week 12||||0.2139
72400943|NCT00663052|144309172|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Fisher Exact|||Comparison between treatment groups at Week 24||||1.0000
72400944|NCT00663052|144309174|SUPERIORITY_OR_OTHER|||||||0.2443|TWO_SIDED||||||Fisher Exact|||Comparison between treatment groups at Week 12||||0.2443
72400945|NCT00663052|144309174|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Fisher Exact|||Comparison between treatment groups at Week 24||||1.0000
72400946|NCT00663052|144309175|SUPERIORITY_OR_OTHER|||||||0.0807|TWO_SIDED||||||ANCOVA|||Comparison of treatment groups at Week 12||||0.0807
72400947|NCT00663052|144309175|SUPERIORITY_OR_OTHER|||||||0.1454|TWO_SIDED||||||ANCOVA|||Comparison of treatment groups at Week 24||||0.1454
72400948|NCT05760300|144309176|OTHER||Geometric Least-squares Mean Ratio|84.5|||||TWO_SIDED|90.0|60.1|119.0|||||Parametric (normal theory) analysis of covariance (ANOVA) model appropriate for a parallel design with renal function group as a fixed effect was fitted to the natural log-transformed values of the multiple dose PK parameter under evaluation.|||119|60.1|
72400949|NCT05760300|144309176|OTHER||Geometric Least-squares Mean Ratio|104.0|||||TWO_SIDED|90.0|80.8|133.0|||||Parametric (normal theory) ANOVA model appropriate for a parallel design with renal function group as a fixed effect was fitted to the natural log-transformed values of the multiple dose PK parameter under evaluation.|||133|80.8|
72400950|NCT05760300|144309177|OTHER||Geometric Least-squares Mean Ratio|106.0|||||TWO_SIDED|90.0|63.6|175.0|||||Parametric (normal theory) ANOVA model appropriate for a parallel design with renal function group as a fixed effect was fitted to the natural log-transformed values of the multiple dose PK parameter under evaluation.|||175|63.6|
72400951|NCT05760300|144309177|OTHER||Geometric Least-squares Mean Ratio|108.0|||||TWO_SIDED|90.0|77.8|151.0|||||Parametric (normal theory) ANOVA model appropriate for a parallel design with renal function group as a fixed effect was fitted to the natural log-transformed values of the multiple dose PK parameter under evaluation.|||151|77.8|
72400952|NCT05760300|144309178|OTHER||Geometric Least-squares Mean Ratio|83.8|||||TWO_SIDED|90.0|67.4|104.0|||||Parametric (normal theory) ANOVA model appropriate for a parallel design with renal function group as a fixed effect was fitted to the natural log-transformed values of the multiple dose PK parameter under evaluation.|||104|67.4|
72480315|NCT01249274|144486886|SUPERIORITY_OR_OTHER||Score Statistic For Type 3 GEE Analysis|0.01||||0.9116|TWO_SIDED||||||Generalized Estimating Equation|Gamma distribution, logit link, 1st-order autoregressive covariance structure; p-value is for chi-sq (df=1) for type 3 GEE analysis score statistic|Estimated value is chi-sq (df=1) for type 3 GEE analysis score statistic for week\*treatment interaction term.|||||0.9116
72400953|NCT05760300|144309178|OTHER||Geometric Least-squares Mean Ratio|100.0|||||TWO_SIDED|90.0|56.2|179.0|||||Parametric (normal theory) ANOVA model appropriate for a parallel design with renal function group as a fixed effect was fitted to the natural log-transformed values of the multiple dose PK parameter under evaluation.|||179|56.2|
72400954|NCT05760300|144309179|OTHER||Geometric Least-squares Mean Ratio|96.5|||||TWO_SIDED|90.0|65.1|143.0|||||Parametric (normal theory) ANOVA model appropriate for a parallel design with renal function group as a fixed effect was fitted to the natural log-transformed values of the multiple dose PK parameter under evaluation.|||143|65.1|
72400955|NCT05760300|144309179|OTHER||Geometric Least-squares Mean Ratio|77.8|||||TWO_SIDED|90.0|42.7|142.0|||||Parametric (normal theory) ANOVA model appropriate for a parallel design with renal function group as a fixed effect was fitted to the natural log-transformed values of the multiple dose PK parameter under evaluation.|||142|42.7|
72480316|NCT01249274|144486889|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|4.71||||0.048|TWO_SIDED|95.0|1.09|20.5|||Regression, Cox||Ratio presented is for placebo versus progesterone|||20.50|1.09|0.048
72480317|NCT01249274|144486890|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|3.5||||0.06|TWO_SIDED|95.0|0.92|13.3|||Regression, Cox||Ratio presented is for placebo versus progesterone|||13.30|0.92|0.06
72480318|NCT01498653|144486950|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|28.5|||<|0.001|TWO_SIDED|95.0|20.1|36.9|||ANCOVA|||||36.9|20.1|<0.001
72480319|NCT01708213|144486967|SUPERIORITY_OR_OTHER||Parametric Testing|0.05|||<|0.05|TWO_SIDED||||||Parametric testing|||||||<0.05
72480320|NCT04964414|144486983|SUPERIORITY|||||||0.6|||||||Paired t-test|||||||0.6
72480321|NCT04964414|144486984|SUPERIORITY|||||||0.6|||||||Wilcoxon signed-rank|||||||0.6
72480322|NCT04964414|144486985|SUPERIORITY|||||||0.09|||||||Paired t-test|||||||0.09
72480323|NCT04964414|144486990|SUPERIORITY|||||||0.2|||||||Paired t-test|||||||0.2
72480324|NCT04964414|144486991|SUPERIORITY|||||||0.2|||||||Paired t-test|||||||0.2
72480325|NCT01718353|144486993|OTHER|||||||0.02|||||||ANOVA|||%ARNL change from baseline at Cycle 1 Day 8 in participants with ≥50% decrease in PSA at Cycle 4 was compared with that of participants who did not have ≥50% decrease in PSA at Cycle 4||||0.02
72480326|NCT01718353|144487001|OTHER|||||||0.0927|||||||ANOVA|||MTB change from baseline at Cycle 1 Day 8 in participants with ≥30% decrease in PSA at Cycle 4 was compared with that of participants who did not have ≥30% decrease in PSA at Cycle 4||||0.0927
72480327|NCT01691768|144487040|NON_INFERIORITY|We estimated that we would need to enrol 700 women after taking into account the anticipated loss-to follow-up in order to provide 90% power to demonstrate whether gel use in women attending family planning (intervention) services is similar to, but no more than 20% lower than, gel use among women attending CAPRISA research clinics (control).|Mean Difference (Final Values)|-0.47|||||TWO_SIDED|95.0|-1.16|0.21||||Univariate Linear Mixed Models were used to analyze primary outcome.|The least square mean from the intervention arm was the minuend and the least square mean from the control arm was the subtrahend.|Intent to treat population (all participants who were randomized, met pre-randomization eligibility criteria and who have post-enrollment follow-up data) was used for this analyses.|The primary endpoint was compared using univariate linear mixed model with compound symmetry structure.|0.21|-1.16|
72480328|NCT01691768|144487040|NON_INFERIORITY|We estimated that we would need to enrol 700 women after taking into account the anticipated loss-to follow-up in order to provide 90% power to demonstrate whether gel use in women attending family planning (intervention) services is similar to, but no more than 20% lower than, gel use among women attending CAPRISA research clinics (control)|Median Difference (Final Values)|-0.25|||||TWO_SIDED|95.0|-0.98|0.48||||Univariable Linear Mixed Models was used for the analyses|We calculated the difference in means between the two arms. The mean from the intervention arm was the minuend and the mean from the control arm was the subtrahend.|This is the analyses from the per protocol population (excluding all subsequent data collected from participants who were not dispensed product for more than 120 days).||0.48|-0.98|
72480329|NCT01691768|144487041|SUPERIORITY||Incidence rate ratio|0.96||||0.928|TWO_SIDED|95.0|0.4|2.35|||z-test|We used z-test to compare incidence rates between the arms. We did not use log-rank test because we did not present survival curves.|We calculated incidence rate ratio, where the HIV incidence rate for the intervention arm represents the numerator and the HIV incidence rate for the control arm represents the denominator.|The power was not calculated for all the secondary outcomes.||2.35|0.40|0.928
72480330|NCT01691768|144487042|SUPERIORITY||incidence rate ratio|0.96||||0.895|TWO_SIDED|95.0|0.45|2.04|||z-test|We used z-test to compare pregnancy incidence rates between the arms. We did not use log-rank test because we did not present survival curves.|We calculated incidence rate ratio, where the pregnancy incidence rate for the intervention arm represents the numerator and the pregnancy incidence rate for the control arm represents the denominator.|Power was not calculated for all the secondary outcomes.||2.04|0.45|0.895
72480331|NCT01691768|144487043|SUPERIORITY||Risk Ratio (RR)|1.08||||0.304|TWO_SIDED|95.0|0.94|1.24|||Regression, Log-binomial|||Power was not calculated for all secondary outcomes.||1.24|0.94|0.304
72480332|NCT01691768|144487044|SUPERIORITY|||||||0.455|||||||t-test, 2 sided|||||||0.455
72480333|NCT01691768|144487046|SUPERIORITY||incidence rate ratio|0.33||||0.097|TWO_SIDED|95.0|0.06|1.32|||z-test||We calculated incidence rate ratio, where the HPV incidence rate for the intervention arm represents the numerator and the HPV incidence rate for the control arm represents the denominator.|||1.32|0.06|0.097
72480334|NCT01691768|144487047|SUPERIORITY||Risk Ratio (RR)|0.91||||0.462|TWO_SIDED|95.0|0.7|1.18|||Regression, Log-binomial|||||1.18|0.70|0.462
72480335|NCT02656160|144487070|OTHER|||||||0.85||||||P\<0.05 considered statistically significant|Wilcoxon (Mann-Whitney)|||tonic||||0.85
72480336|NCT02656160|144487070|OTHER|||||||0.322||||||P\<0.05 considered statistically significant|Wilcoxon (Mann-Whitney)|||Phasic activity||||0.322
72480337|NCT02656160|144487071|OTHER|||||||0.42||||||P\<0.05 considered statistically significant|Wilcoxon (Mann-Whitney)|||||||0.42
72480338|NCT00446992|144487075|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Univariate linear regression|||Baseline compared to Week 16||||<0.001
72480339|NCT00446992|144487076|SUPERIORITY_OR_OTHER|||||||0.043|TWO_SIDED||||||Univariate linear regression|||Baseline compared to Week 16||||.043
72480340|NCT00446992|144487077|SUPERIORITY_OR_OTHER||||||=|0.69|TWO_SIDED||||||Univariate linear regression|||Baseline compared to Week 16||||= 0.690
72480341|NCT00446992|144487078|SUPERIORITY_OR_OTHER||||||=|0.691|TWO_SIDED||||||Intervariate|||Baseline compared to Week 16||||= 0.691
72480342|NCT00446992|144487079|SUPERIORITY_OR_OTHER||||||=|0.877|TWO_SIDED||||||Univariate linear regression|||Baseline compared to Week 16||||= 0.877
72480343|NCT00446992|144487080|SUPERIORITY_OR_OTHER||||||=|0.003|TWO_SIDED||||||Univariate linear regression|||Baseline compared to Week 16||||= 0.003
72480344|NCT00446992|144487081|SUPERIORITY_OR_OTHER||||||=|0.005|TWO_SIDED||||||Univariate linear regression|||Baseline compared to Week 16||||= .005
72480345|NCT00446992|144487082|SUPERIORITY_OR_OTHER||||||=|0.696|TWO_SIDED||||||Univariate linear regression|||Baseline compared to Week 16||||= 0.696
72480346|NCT00446992|144487083|SUPERIORITY_OR_OTHER||||||=|0.013|TWO_SIDED||||||Univariate linear regression|||Baseline compared to Week 16||||= 0.013
72480347|NCT02076178|144487084|SUPERIORITY_OR_OTHER||||||<|0.01|||||||Fisher Exact|||Any Grade 2 or higher event, any Grade 2 or higher event Vs Cabotegravir||||<0.01
72480348|NCT02434939|144487142|NON_INFERIORITY_OR_EQUIVALENCE|a clinically significant difference in validated pain scores was defined as 1.3. assuming both treatments are on average equal, 240 patients provided 95% power to demonstrate that IV low dose ketamine is non inferior to IV morphine with a 0.05 level of significance.|Mean Difference (Final Values)|5.5||||0.18|TWO_SIDED|95.0|-2.2|13.2|||t-test, 2 sided|||||13.2|-2.2|0.18
72480349|NCT02434939|144487145|NON_INFERIORITY_OR_EQUIVALENCE|A clinically meaningful difference in validated pain scores was defined as 1.3.Assuming both treatments are on average equal, a sample size of 240 patients (120 per group) provided 95% power to demonstrate that IV LDK is non-inferior to IV morphine with a 0.05 level of significance.||||||0.07|||||||t-test, 2 sided|||||||0.07
72480350|NCT00710021|144487152|SUPERIORITY_OR_OTHER|||||||0.53||||||The p-value compares the Placebo with the pooled Vitamin D treatment group.|Fisher Exact|||||||0.53
72480351|NCT00710021|144487153|SUPERIORITY_OR_OTHER|||||||0.038||||||The p-value compares the Placebo with the pooled Vitamin D treatment group.|Fisher Exact|||||||0.038
72510015|NCT05372575|144550708|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|4.86|||||TWO_SIDED|95.0|2.15|10.96|||||GMR=(GMT of 13vPnC VT- or Sp- Subgroup)/(GMT of non-13vPnC VT- or Sp- Subgroup)|GMR of 13vPnC Cohort/non-13vPnC Cohort in VT- or Sp- Subgroups for Serotype: 1||10.96|2.15|
72510016|NCT05372575|144550708|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|9.57|||||TWO_SIDED|95.0|4.5|20.36|||||GMR=(GMT of 13vPnC VT- or Sp- Subgroup)/(GMT of non-13vPnC VT- or Sp- Subgroup)|GMR of 13vPnC Cohort/non-13vPnC Cohort in VT- or Sp- Subgroups for Serotype: 3||20.36|4.50|
72400956|NCT05760300|144309184|OTHER||Geometric Least-squares Mean Ratio|160.0|||||TWO_SIDED|90.0|97.2|263.0|||||Parametric (normal theory) ANOVA model appropriate for a parallel design with renal function group as a fixed effect was fitted to the natural log-transformed values of the multiple dose PK parameter under evaluation.|Day 1||263|97.2|
72566685|NCT00700817|144663784|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority concluded if upper confidence interval of test was below 0.4%. Superiority concluded if upper limit of confidence interval was below 0%.|Estimated Treatment Difference, LS Mean|-0.63||||0.0001||95.0|-0.81|-0.44||Multiple comparisons not applicable due to the hieracheal testing.|ANCOVA|Adjusted for treatment and country (fixed effects) and baseline HbA1c (covariate).|Lira 1.8 - Sita|ANCOVA with treatment and country as fixed effects and baseline HbA1c as covariate.||-0.44|-0.81|0.0001
72400957|NCT05760300|144309184|OTHER||Geometric Least-squares Mean Ratio|65.9|||||TWO_SIDED|90.0|35.0|124.0|||||Parametric (normal theory) ANOVA model appropriate for a parallel design with renal function group as a fixed effect was fitted to the natural log-transformed values of the multiple dose PK parameter under evaluation.|Day 6||124|35.0|
72400958|NCT05760300|144309184|OTHER||Geometric Least-squares Mean Ratio|86.7|||||TWO_SIDED|90.0|53.3|141.0|||||Parametric (normal theory) ANOVA model appropriate for a parallel design with renal function group as a fixed effect was fitted to the natural log-transformed values of the multiple dose PK parameter under evaluation.|Day 1||141|53.3|
72480352|NCT00710021|144487154|SUPERIORITY_OR_OTHER|||||||0.047||||||The p-value compares the Placebo with the pooled Vitamin D treatment group.|Fisher Exact|||||||0.047
72480353|NCT00710021|144487155|SUPERIORITY_OR_OTHER|||||||0.12||||||The p-value compares the Placebo with the pooled Vitamin D treatment group.|Fisher Exact|||||||0.12
72480354|NCT00710021|144487156|SUPERIORITY_OR_OTHER|||||||0.31||||||The p-value compares the Placebo with the pooled Vitamin D treatment group.|F-tests derived from the GLM|The test was for the comparison of pooled Vitamin D versus Placebo after adjustment for baseline Ifit1 expression.||||||0.31
72480355|NCT00710021|144487157|SUPERIORITY_OR_OTHER|||||||0.019||||||The p-value compares the Placebo with the pooled Vitamin D treatment group.|F-tests derived from the GLM|The test was for the comparison of pooled Vitamin D versus Placebo after adjustment for baseline Ifit1 expression.||||||0.019
72480356|NCT00710021|144487158|SUPERIORITY_OR_OTHER|||||||0.28||||||The p-value compares the Placebo with the pooled Vitamin D treatment group.|F-tests derived from the GLM|The test was for the comparison of pooled Vitamin D versus Placebo after adjustment for baseline Ifi44 expression.||||||0.28
72480357|NCT00710021|144487159|SUPERIORITY_OR_OTHER|||||||0.05||||||The p-value compares the Placebo with the pooled Vitamin D treatment group.|F-tests derived from the GLM|The test was for the comparison of pooled Vitamin D versus Placebo after adjustment for baseline Ifi44 expression.||||||0.050
72480358|NCT00710021|144487160|SUPERIORITY_OR_OTHER|||||||0.29||||||The p-value compares the Placebo with the pooled Vitamin D treatment group.|F-tests derived from the GLM|The test was for the comparison of pooled Vitamin D versus Placebo after adjustment for baseline Mx1 expression.||||||0.29
72623925|NCT00427700|144778290|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|12.0||||0.3|TWO_SIDED|95.0|-9.0|33.0|||Fisher Exact|||The null hypothesis is that there is no significant difference between two drugs for ovulation induction.A sample size of 40 women per arm was calculated for this superiority trial, considering an alpha and beta error of 0.05 and 0.2, respectively, to find an absolute difference of 30% in the ovulation rate between groups, based on a previous study published by Mitwally and Casper (18) where the ovulation rate with CC was approximately 45%.||33|-9|0.3
72400959|NCT05760300|144309184|OTHER||Geometric Least-squares Mean Ratio|72.6|||||TWO_SIDED|90.0|50.4|105.0|||||Parametric (normal theory) ANOVA model appropriate for a parallel design with renal function group as a fixed effect was fitted to the natural log-transformed values of the multiple dose PK parameter under evaluation.|Day 6||105|50.4|
72400960|NCT05760300|144309185|OTHER||Geometric Least-squares Mean Ratio|139.0|||||TWO_SIDED|90.0|87.8|221.0|||||Parametric (normal theory) ANOVA model appropriate for a parallel design with renal function group as a fixed effect was fitted to the natural log-transformed values of the multiple dose PK parameter under evaluation.|Day 1||221|87.8|
72510017|NCT05372575|144550708|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|13.4|||||TWO_SIDED|95.0|5.2|34.51|||||GMR=(GMT of 13vPnC VT- or Sp- Subgroup)/(GMT of non-13vPnC VT- or Sp- Subgroup)|GMR of 13vPnC Cohort/non-13vPnC Cohort in VT- or Sp- Subgroups for Serotype: 4||34.51|5.20|
72480359|NCT00710021|144487161|SUPERIORITY_OR_OTHER|||||||0.014||||||The p-value compares the Placebo with the pooled Vitamin D treatment group.|F-tests derived from the GLM|The test was for the comparison of pooled Vitamin D versus Placebo after adjustment for baseline Mx1 expression.||||||0.014
72480360|NCT00710021|144487162|SUPERIORITY_OR_OTHER|||||||0.96||||||The p-value compares the Placebo with the pooled Vitamin D treatment group.|F-tests derived from the GLM|The test was for the comparison of pooled Vitamin D versus Placebo after adjustment for baseline serum C3 level.||||||0.96
72480361|NCT00710021|144487163|SUPERIORITY_OR_OTHER|||||||0.67||||||The p-value compares the Placebo with the pooled Vitamin D treatment group.|F-tests derived from the GLM|The test was for the comparison of pooled Vitamin D versus Placebo after adjustment for baseline serum C3 level.||||||0.67
72480362|NCT00710021|144487164|SUPERIORITY_OR_OTHER|||||||0.59||||||The p-value compares the Placebo with the pooled Vitamin D treatment group.|F-tests derived from the GLM|The test was for the comparison of pooled Vitamin D versus Placebo after adjustment for baseline serum C4 level.||||||0.59
72480363|NCT00710021|144487165|SUPERIORITY_OR_OTHER|||||||0.65||||||The p-value compares the Placebo with the pooled Vitamin D treatment group.|F-tests derived from the GLM|The test was for the comparison of pooled Vitamin D versus Placebo after adjustment for baseline serum C4 level.||||||0.65
72480364|NCT00710021|144487166|SUPERIORITY_OR_OTHER|||||||0.86||||||The p-value compares the Placebo with the pooled Vitamin D treatment group.|Fisher Exact|||||||0.86
72480365|NCT00710021|144487167|SUPERIORITY_OR_OTHER|||||||1||||||The p-value compares the Placebo with the pooled Vitamin D treatment group.|Fisher Exact|||||||1.0
72480366|NCT00710021|144487168|SUPERIORITY_OR_OTHER|||||||0.62||||||The p-value compares the Placebo with the pooled Vitamin D treatment group.|F-tests derived from the GLM|The test was for the comparison of pooled Vitamin D versus Placebo after adjustment for baseline SELENA-SLEDAI score.||||||0.62
72480367|NCT00710021|144487169|SUPERIORITY_OR_OTHER|||||||1||||||The p-value compares the Placebo with the pooled Vitamin D treatment group.|Fisher Exact|||||||1.0
72510018|NCT05372575|144550708|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|17.15|||||TWO_SIDED|95.0|7.76|37.91|||||GMR=(GMT of 13vPnC VT- or Sp- Subgroup)/(GMT of non-13vPnC VT- or Sp- Subgroup)|GMR of 13vPnC Cohort/non-13vPnC Cohort in VT- or Sp- Subgroups for Serotype: 5||37.91|7.76|
72510019|NCT05372575|144550708|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|40.2|||||TWO_SIDED|95.0|15.16|106.65|||||GMR=(GMT of 13vPnC VT- or Sp- Subgroup)/(GMT of non-13vPnC VT- or Sp- Subgroup)|GMR of 13vPnC Cohort/non-13vPnC Cohort in VT- or Sp- Subgroups for Serotype: 6A||106.65|15.16|
72480368|NCT00710021|144487170|SUPERIORITY_OR_OTHER|||||||1||||||The p-value compares the Placebo with the pooled Vitamin D treatment group.|Fisher Exact|||||||1.0
72480369|NCT00710021|144487171|SUPERIORITY_OR_OTHER|||||||1||||||The p-value compares the Placebo with the pooled Vitamin D treatment group.|Fisher Exact|||||||1.0
72480370|NCT00710021|144487172|SUPERIORITY_OR_OTHER|||||||1||||||The p-value compares the Placebo with the pooled Vitamin D treatment group.|Fisher Exact|||||||1.0
72480371|NCT00710021|144487173|SUPERIORITY_OR_OTHER|||||||1||||||The p-value compares the Placebo with the pooled Vitamin D treatment group.|Fisher Exact|||||||1.0
72480372|NCT00710021|144487174|SUPERIORITY_OR_OTHER|||||||1||||||The p-value compares the Placebo with the pooled Vitamin D treatment group.|Fisher Exact|||||||1.0
72480373|NCT00710021|144487175|SUPERIORITY_OR_OTHER|||||||1||||||The p-value compares the Placebo with the pooled Vitamin D treatment group.|Fisher Exact|||||||1.0
72480374|NCT00710021|144487176|SUPERIORITY_OR_OTHER|||||||1||||||The p-value compares the Placebo with the pooled Vitamin D treatment group.|Fisher Exact|||||||1.0
72480375|NCT00710021|144487177|SUPERIORITY_OR_OTHER|||||||1||||||The p-value compares the Placebo with the pooled Vitamin D treatment group.|Fisher Exact|||||||1.0
72480376|NCT00710021|144487178|SUPERIORITY_OR_OTHER|||||||0.1||||||The p-value compares the Placebo with the pooled Vitamin D treatment group.|Cochran-Mantel-Haenszel|Note that none of the Grade 3 or above events were considered by the investigators to be related to study treatment.||||||0.10
72480377|NCT00511901|144487199|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.7||||0.02||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.02
72480378|NCT00511901|144487200|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.8||||1||95.0|||||Wilcoxon (Mann-Whitney)|||FIM at 3 weeks||||1.00
72480379|NCT00511901|144487200|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.3||||0.17||95.0|||||Wilcoxon (Mann-Whitney)|||FIM at 8 weeks||||0.17
72480380|NCT00511901|144487200|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1||||0.59||95.0|||||Wilcoxon (Mann-Whitney)|||FIM at 12 weeks||||0.59
72480381|NCT00511901|144487201|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.3||||0.21||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.21
72480382|NCT00511901|144487202|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.6||||0.66||95.0|||||Wilcoxon (Mann-Whitney)|||Grip strength at 3 weeks||||0.66
72480383|NCT00511901|144487202|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.2||||1||95.0|||||Wilcoxon (Mann-Whitney)|||Grip strength at 8 weeks||||1.00
72480384|NCT00511901|144487202|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.6||||0.53||95.0|||||Wilcoxon (Mann-Whitney)|||Grip strength at 12 weeks||||0.53
72480385|NCT00511901|144487203|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.3||||0.96||95.0|||||Wilcoxon (Mann-Whitney)|||SPPB at 3 weeks||||0.96
72480386|NCT00511901|144487203|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.4||||1||95.0|||||Wilcoxon (Mann-Whitney)|||SPPB at 8 weeks||||1.00
72480387|NCT00511901|144487203|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.9||||0.66||95.0|||||Wilcoxon (Mann-Whitney)|||SPPB at 12 weeks||||0.66
72510020|NCT05372575|144550708|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|20.38|||||TWO_SIDED|95.0|8.39|49.51|||||GMR=(GMT of 13vPnC VT- or Sp- Subgroup)/(GMT of non-13vPnC VT- or Sp- Subgroup)|GMR of 13vPnC Cohort/non-13vPnC Cohort in VT- or Sp- Subgroups for Serotype: 6B||49.51|8.39|
72480388|NCT00511901|144487204|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.6||||0.64||95.0|||||Wilcoxon (Mann-Whitney)|||FACIT at 3 weeks||||0.64
72480389|NCT00511901|144487204|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.5||||0.83||95.0|||||Wilcoxon (Mann-Whitney)|||FACIT at 8 weeks||||0.83
72480390|NCT00511901|144487204|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.1||||0.46||95.0|||||Wilcoxon (Mann-Whitney)|||FACIT at 12 weeks||||0.46
72480391|NCT00511901|144487205|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-9.57||||0.37||95.0|||||Wilcoxon (Mann-Whitney)|||Activity Counts at 3 weeks||||0.37
72480392|NCT00511901|144487205|SUPERIORITY_OR_OTHER||Mean Difference (Net)|11.39||||0.69||95.0|||||Wilcoxon (Mann-Whitney)|||Activity Counts at 8 weeks||||0.69
72480393|NCT00511901|144487205|SUPERIORITY_OR_OTHER||Mean Difference (Net)|16.15||||0.36||95.0|||||Wilcoxon (Mann-Whitney)|||Activity Counts at 12 weeks||||0.36
72480394|NCT00511901|144487206|SUPERIORITY_OR_OTHER||Median Difference (Net)|2.5||||0.97||95.0|||||Wilcoxon (Mann-Whitney)|||POMS at 3 weeks||||0.97
72480395|NCT00511901|144487206|SUPERIORITY_OR_OTHER||Median Difference (Net)|-1.0||||0.46||95.0|||||Wilcoxon (Mann-Whitney)|||POMS at 8 weeks||||0.46
72480396|NCT00511901|144487206|SUPERIORITY_OR_OTHER||Median Difference (Net)|-1.0||||0.68||95.0|||||Wilcoxon (Mann-Whitney)|||POMS at 12 weeks||||0.68
72480397|NCT04234425|144487219|OTHER|paired t test|Mean Difference (Final Values)|2.702|STANDARD_DEVIATION|5.36||0.017|TWO_SIDED||||||t-test, 2 sided|||||||.017
72480398|NCT04234425|144487220|OTHER|paired t test|Mean Difference (Final Values)|4.2|STANDARD_DEVIATION|7.06||0.08|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.08
72566686|NCT00700817|144663784|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority concluded if upper confidence interval of test was below 0.4%. Superiority concluded if upper limit of confidence interval was below 0%.|Estimated Treatment Difference, LS Mean|-0.4||||0.0001||95.0|-0.59|-0.22||Multiple comparisons not applicable due to the hieracheal testing.|ANCOVA|Adjusted for treatment and country (fixed effects) and baseline HbA1c (covariate).|Lira 1.2 - Sita|ANCOVA with treatment and country as fixed effects and baseline HbA1c as covariate.||-0.22|-0.59|0.0001
72566687|NCT00700817|144663786|SUPERIORITY_OR_OTHER||Change within treatment group|-0.24|STANDARD_DEVIATION|0.7||0.006||95.0|-0.41|-0.07||Multiple comparisons is not applicable.|paired t-test|The analysis is not a controlled comparison, and there are no adjustments||The t-test was performed to examine whether the change in HbA1c from week 52 to week 78 were different from 0 within each treatment group.||-0.07|-0.41|0.0060
72566688|NCT00700817|144663786|SUPERIORITY_OR_OTHER||Change within treatment group|-0.45|STANDARD_DEVIATION|0.9||0.0001||95.0|-0.67|-0.23||Multiple comparisons is not applicable.|paired t-test|The analysis is not a controlled comparison, and there are no adjustments||The t-test was performed to examine whether the change in HbA1c from week 52 to week 78 were different from 0 within each treatment group.||-0.23|-0.67|0.0001
72480399|NCT04234425|144487221|OTHER|paired t test|Mean Difference (Final Values)|20.47|STANDARD_DEVIATION|7.33||0.026|TWO_SIDED||||||t-test, 2 sided|||||||.026
72480400|NCT03442985|144487223|OTHER||Risk Ratio (RR)|2.109||||0.2556|TWO_SIDED|95.0|0.583|7.638||The p-values were not adjusted for multiple testing due to small sample size.|Negative binomial regression model|||Palovarotene 2.5 mg versus (vs) Palovarotene 5.0 mg: The annualized rate for number of new OCs was estimated using an unadjusted negative binomial regression model, offsetted by log-transformed follow-up time (years) to obtain annualized rate.||7.638|0.583|0.2556
72480401|NCT03442985|144487223|OTHER||Risk Ratio (RR)|3.04||||0.1788|TWO_SIDED|95.0|0.601|15.373||The p-values were not adjusted for multiple testing due to small sample size.|Negative binomial regression model|||Palovarotene 2.5 mg vs Placebo: The annualized rate for number of new OCs was estimated using an unadjusted negative binomial regression model, offsetted by log-transformed follow-up time (years) to obtain annualized rate.||15.373|0.601|0.1788
72480402|NCT03442985|144487223|OTHER||Risk Ratio (RR)|1.441||||0.657|TWO_SIDED|95.0|0.287|7.234||The p-values were not adjusted for multiple testing due to small sample size.|Negative binomial regression model|||Palovarotene 5.0 mg vs Placebo: The annualized rate for number of new OCs was estimated using an unadjusted negative binomial regression model, offsetted by log-transformed follow-up time (years) to obtain annualized rate.||7.234|0.287|0.6570
72480403|NCT03442985|144487224|OTHER||Risk Ratio (RR)|-4412.6||||0.4252|TWO_SIDED|95.0|-15257.3|6432.1||The p-values were not adjusted for multiple testing due to small sample size.|Unadjusted estimation equation model|||Palovarotene 2.5 mg vs Palovarotene 5.0 mg: The mean difference in the change from baseline for total OC volume was estimated using an unadjusted estimation equation model with independent working covariance matrix to address potential correlation within the same family members.||6432.1|-15257.3|0.4252
72480404|NCT03442985|144487224|OTHER||Risk Ratio (RR)|-4640.9||||0.4053|TWO_SIDED|95.0|-15570.8|6289.0||The p-values were not adjusted for multiple testing due to small sample size.|Unadjusted estimation equation model|||Palovarotene 2.5 mg vs Placebo: The mean difference in the change from baseline for total OC volume was estimated using an unadjusted estimation equation model with independent working covariance matrix to address potential correlation within the same family members.||6289.0|-15570.8|0.4053
72480405|NCT03442985|144487224|OTHER||Risk Ratio (RR)|-228.3||||0.9677|TWO_SIDED|95.0|-11265.0|10808.4||The p-values were not adjusted for multiple testings due to small sample size.|Unadjusted estimation equation model|||Palovarotene 5.0 mg vs Placebo: The mean difference in the change from baseline for total OC volume was estimated using an unadjusted estimation equation model with independent working covariance matrix to address potential correlation within the same family members.||10808.4|-11265.0|0.9677
72480406|NCT03442985|144487225|OTHER||Odds Ratio (OR)|0.643||||0.5025|TWO_SIDED|95.0|0.177|2.335|||Regression, Logistic|Logistic regression was adjusted for the following covariates: baseline age, sex, and Ext1/2 mutation status.||||2.335|0.177|0.5025
72480407|NCT03442985|144487225|OTHER||Odds Ratio (OR)|0.528||||0.3763|TWO_SIDED|95.0|0.128|2.175|||Regression, Logistic|Logistic regression was adjusted for the following covariates: baseline age, sex, and Ext1/2 mutation status.||||2.175|0.128|0.3763
72480408|NCT03442985|144487225|OTHER||Odds Ratio (OR)|0.82||||0.7714|TWO_SIDED|95.0|0.215|3.123|||Regression, Logistic|Logistic regression was adjusted for the following covariates: baseline age, sex, and Ext1/2 mutation status.||||3.123|0.215|0.7714
72480409|NCT03442985|144487226|OTHER||Risk Ratio (RR)|0.951||||0.8155|TWO_SIDED|95.0|0.623|1.451||The p-values were not adjusted for multiple testing due to small sample size. The correlation matrix type = compound symmetry was used.|Negative binomial regression model|||Palovarotene 2.5 mg vs Palovarotene 5.0 mg: The annualized rate for number of new or worsening deformities was estimated using an unadjusted negative binomial regression model, offsetted by log-transformed follow-up time (years) to obtain annualized rate.||1.451|0.623|0.8155
72566689|NCT00767520|144663858|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.82||||0.148|||||||Un-stratified log-rank test|||||||0.148
72566690|NCT00720226|144663883|SUPERIORITY|||||||0.06|||||||t-test, 2 sided|||Participants demonstrating 5-35% emphysema on baseline CT scan||||0.06
72400961|NCT05760300|144309185|OTHER||Geometric Least-squares Mean Ratio|66.8|||||TWO_SIDED|90.0|37.3|120.0|||||Parametric (normal theory) ANOVA model appropriate for a parallel design with renal function group as a fixed effect was fitted to the natural log-transformed values of the multiple dose PK parameter under evaluation.|Day 6||120|37.3|
72400962|NCT05760300|144309185|OTHER||Geometric Least-squares Mean Ratio|85.7|||||TWO_SIDED|90.0|54.5|135.0|||||Parametric (normal theory) ANOVA model appropriate for a parallel design with renal function group as a fixed effect was fitted to the natural log-transformed values of the multiple dose PK parameter under evaluation.|Day 1||135|54.5|
72400963|NCT05760300|144309185|OTHER||Geometric Least-squares Mean Ratio|70.3|||||TWO_SIDED|90.0|49.4|100.0|||||Parametric (normal theory) ANOVA model appropriate for a parallel design with renal function group as a fixed effect was fitted to the natural log-transformed values of the multiple dose PK parameter under evaluation.|Day 6||100|49.4|
72400964|NCT05760300|144309186|OTHER||Geometric Least-squares Mean Ratio|84.2|||||TWO_SIDED|90.0|32.7|217.0|||||Parametric (normal theory) ANOVA model appropriate for a parallel design with renal function group as a fixed effect was fitted to the natural log-transformed values of the multiple dose PK parameter under evaluation.|Day 1||217|32.7|
72400965|NCT05760300|144309186|OTHER||Geometric Least-squares Mean Ratio|58.0|||||TWO_SIDED|90.0|30.1|112.0|||||Parametric (normal theory) ANOVA model appropriate for a parallel design with renal function group as a fixed effect was fitted to the natural log-transformed values of the multiple dose PK parameter under evaluation.|Day 6||112|30.1|
72400966|NCT05760300|144309186|OTHER||Geometric Least-squares Mean Ratio|85.6|||||TWO_SIDED|90.0|54.1|135.0|||||Parametric (normal theory) ANOVA model appropriate for a parallel design with renal function group as a fixed effect was fitted to the natural log-transformed values of the multiple dose PK parameter under evaluation.|Day 1||135|54.1|
72400967|NCT05760300|144309186|OTHER||Geometric Least-squares Mean Ratio|69.6|||||TWO_SIDED|90.0|48.9|99.2|||||Parametric (normal theory) ANOVA model appropriate for a parallel design with renal function group as a fixed effect was fitted to the natural log-transformed values of the multiple dose PK parameter under evaluation.|Day 6||99.2|48.9|
72400968|NCT00877058|144309189|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.27|||<|0.05|TWO_SIDED|95.0|0.15|0.48|||Chi-squared|||||0.48|0.15|<0.05
72566691|NCT00720226|144663884|SUPERIORITY|||||||0.55|||||||t-test, 2 sided|||Participants with 5-35% emphysema at baseline||||0.55
72566692|NCT00279955|144663950|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|2.07|STANDARD_DEVIATION|0.292||0.0119|TWO_SIDED|95.0|1.17|3.67|||Regression, Cox||The estimated parameter in a Cox regression model was adjusted by age, gender, New York Heart Association (NYHA) class at 6 month visit, Angiotensin Converting Enzyme (ACE)/Angiotensin Receptor Blocker (ARB) at 6 months, and Diuretics at 6 month.|||3.67|1.17|0.0119
72566693|NCT00279955|144663951|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.9|STANDARD_DEVIATION|0.277||0.0185|TWO_SIDED|95.0|1.11|3.27|||Regression, Cox||The estimated parameter in a Cox regression model was adjusted by age, gender, NYHA class at 6 month visit, ACE/ARB at 6 months, and and at least one day where CRT pacing \<90% in last 21 days of DREP.|||3.27|1.11|0.0185
72400969|NCT00877058|144309189|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.4||||0.001|TWO_SIDED|0.05|0.24|0.68|||Chi-squared|||||0.68|0.24|0.001
72400970|NCT00877058|144309190|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.56|||<|0.05|TWO_SIDED|95.0|0.96|2.52|||Chi-squared|||||2.52|0.96|<0.05
72400971|NCT00877058|144309190|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.28|||<|0.05|TWO_SIDED|95.0|0.79|2.08|||Chi-squared|||||2.08|0.79|<0.05
72400972|NCT00877058|144309191|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.55|||<|0.05|TWO_SIDED|95.0|0.31|0.97|||Chi-squared|||||0.97|0.31|<0.05
72400973|NCT00877058|144309191|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.58|||<|0.05|TWO_SIDED|95.0|0.33|1.02|||Chi-squared|||||1.02|0.33|<0.05
72400974|NCT03628703|144309195|SUPERIORITY|||||||0.49|||||||t-test, 2 sided|||||||0.49
72400975|NCT04350788|144309200|SUPERIORITY|||||||0.02|||||||t-test, 1 sided|||We analyzed program satisfaction between SCP and ESCP by role (patient vs partner). The following result is for patient.||||0.02
72400976|NCT04350788|144309200|SUPERIORITY|||||||0.25|||||||t-test, 1 sided|||We analyzed program satisfaction between SCP and ESCP by role (patient vs partner). The following result is for partner.||||0.25
72400977|NCT04350788|144309201|SUPERIORITY|||||||0.36|||||||t-test, 1 sided|||We analyzed this measure between SCP and ESCP by role (patient vs partner) and by domain. The following result is for patient in general domain.||||0.36
72400978|NCT04350788|144309201|SUPERIORITY|||||||0.38|||||||t-test, 1 sided|||We analyzed this measure between SCP and ESCP by role (patient vs partner) and by domain. The following result is for patient in content domain.||||0.38
72400979|NCT04350788|144309201|SUPERIORITY|||||||0.02|||||||t-test, 1 sided|||We analyzed this measure between SCP and ESCP by role (patient vs partner) and by domain. The following result is for patient in navigation domain.||||0.02
72400980|NCT04350788|144309201|SUPERIORITY|||||||0.62|||||||t-test, 1 sided|||We analyzed this measure between SCP and ESCP by role (patient vs partner) and by domain. The following result is for partner in general domain.||||0.62
72400981|NCT04350788|144309201|SUPERIORITY|||||||0.65|||||||t-test, 1 sided|||We analyzed this measure between SCP and ESCP by role (patient vs partner) and by domain. The following result is for partner in content domain.||||0.65
72400982|NCT04350788|144309201|SUPERIORITY|||||||0.45|||||||t-test, 1 sided|||We analyzed this measure between SCP and ESCP by role (patient vs partner) and by domain. The following result is for partner in navigation domain.||||0.45
72400983|NCT04350788|144309202|SUPERIORITY|||||||0.35|||||||Mixed Models Analysis|||||||0.35
72400984|NCT04350788|144309203|SUPERIORITY|||||||0.01|||||||ANCOVA|||We analyzed this measure between SCP and ESCP by role (patient vs partner) and by domain. The following result is for patient in urinary domain.||||0.01
72566694|NCT00279955|144663952|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.8|STANDARD_DEVIATION|0.311||0.0578|TWO_SIDED|95.0|0.98|3.31|||Regression, Cox||A Cox regression model has been used here, and the estimated parameter has been adjusted by including covariates age, gender, and NYHA class at 6 months.|||3.31|0.98|0.0578
72566695|NCT01770431|144663985|SUPERIORITY||chi-squared|14.7315||||0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.0001
72400985|NCT04350788|144309203|SUPERIORITY|||||||0.41|||||||ANCOVA|||We analyzed this measure between SCP and ESCP by role (patient vs partner) and by domain. The following result is for patient in bowel domain.||||0.41
72400986|NCT04350788|144309203|SUPERIORITY|||||||0.21|||||||ANCOVA|||We analyzed this measure between SCP and ESCP by role (patient vs partner) and by domain. The following result is for patient in sexual domain.||||0.21
72400987|NCT04350788|144309203|SUPERIORITY|||||||0.52|||||||ANCOVA|||We analyzed this measure between SCP and ESCP by role (patient vs partner) and by domain. The following result is for patient in hormonal domain.||||0.52
72400988|NCT04350788|144309203|SUPERIORITY|||||||0.79|||||||ANCOVA|||We analyzed this measure between SCP and ESCP by role (patient vs partner) and by domain. The following result is for partner in urinary domain.||||0.79
72400989|NCT04350788|144309203|SUPERIORITY|||||||0.84|||||||ANCOVA|||We analyzed this measure between SCP and ESCP by role (patient vs partner) and by domain. The following result is for partner in bowel domain.||||0.84
72400990|NCT04350788|144309203|SUPERIORITY|||||||0.82|||||||ANCOVA|||We analyzed this measure between SCP and ESCP by role (patient vs partner) and by domain. The following result is for partner in sexual domain.||||0.82
72400991|NCT04350788|144309203|SUPERIORITY|||||||0.33|||||||ANCOVA|||We analyzed this measure between SCP and ESCP by role (patient vs partner) and by domain. The following result is for partner in hormonal domain.||||0.33
72400992|NCT04350788|144309204|SUPERIORITY|||||||0.18|||||||ANCOVA|||||||0.18
72400993|NCT04350788|144309204|SUPERIORITY|||||||0.38|||||||ANCOVA|||||||0.38
72566696|NCT01770431|144663986|SUPERIORITY||Hazard Ratio (HR)|0.67|||<|0.0001|TWO_SIDED|95.0|0.55|0.81|||Regression, Cox|||||0.81|0.55|<0.0001
72623926|NCT00427700|144778291|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|13.0||||0.2|TWO_SIDED|95.0|-6.0|34.0|||t-test, 2 sided|||Null hypothesis: There is no difference between the mean values of progesterone between both groups.||34|-6|0.2
72400994|NCT04350788|144309205|SUPERIORITY|||||||0.05|||||||generalized linear regression|||||||0.05
72566697|NCT02149121|144664048|EQUIVALENCE|The equivalence of PK was to be concluded if the 90% CI for the ratio of geometric means in AUC0-last, AUC0-inf, and Cmax was entirely contained within the PK equivalence bounds of 80% and 125% for the following comparisons: CT-P10 versus Rituxan, CT-P10 versus MabThera, and Rituxan versus MabThera.|Ratio of geometric least squares means|97.07|||||TWO_SIDED|90.0|88.08|106.99|||||Point estimates (geometric least squares means and ratios of geometric means) were calculated by back-transforming the least squares means.|Primary PK analysis were analyzed using analysis of covariance (ANCOVA) model with treatment group as a fixed effect and gender, region, race, prior anti TNF alpha blocker status, and RF or anti-CCP status fitted as covariates.||106.99|88.08|
72400995|NCT04350788|144309206|SUPERIORITY|||||||0.1|||||||Mixed Models Analysis|||||||0.10
72400996|NCT04350788|144309207|SUPERIORITY|||||||0.29|||||||Mixed Models Analysis|||||||0.29
72400997|NCT04350788|144309208|SUPERIORITY|||||||0.49|||||||Mixed Models Analysis|||||||0.49
72400998|NCT04350788|144309209|SUPERIORITY|||||||0.09|||||||Mixed Models Analysis|||||||0.09
72400999|NCT04350788|144309210|SUPERIORITY|||||||0.16|||||||Mixed Models Analysis|||||||0.16
72401000|NCT04350788|144309211|SUPERIORITY|||||||0.55|||||||Mixed Models Analysis|||||||0.55
72401001|NCT01252940|144309217|NON_INFERIORITY_OR_EQUIVALENCE|A 95% confidence interval (CI) for the difference between treatment groups in the percentages of virologic success was constructed using normal approximation. Noninferiority was assessed using a conventional 95% CI approach, with a noninferiority margin of 12%. It would be concluded that the FTC/RPV/TDF STR group was not inferior to the SBR group if the lower bound of the 2-sided 95% CI of the difference (FTC/RPV/TDF STR - SBR) in the response rate was greater than -12%.|Mean Difference (Net)|3.8|||||TWO_SIDED|95.0|-1.6|9.1||||||||9.1|-1.6|
72410246|NCT03224468|144328801|SUPERIORITY|Power was determined to be 84.3% using a Monte Carlo simulation approach in which data were simulated from a multi-level linear regression model with a subject-varying random intercept, a shared baseline across WLC and MMC, and fixed effects for a change over each time point. Simulated data were fit with a linear model estimated via GEE - simulations were repeated 1000 times and power was estimated as the proportion where the contrast between WLC and MM had p\<0.05.|Mean Difference (Net)|-0.02|STANDARD_ERROR_OF_MEAN|0.5||0.9|TWO_SIDED|95.0|-0.3|0.24||The p-value is adjusted for multiple comparisons using per Benjamini \& Hochberg (1995) across the five primary outcome measures. Effects were deemed significant for p\<0.05.|Regression, Linear|Estimates were obtained using generalized estimating equations (GEE) with robust standard errors obtained by the sandwich estimator.|Estimate is the mean difference in number of symptoms for MM above and beyond WLC (positive values denote higher number of symptoms for MM).|The mean difference in number of symptoms between the MM and WLC groups was estimated via a linear model with a dummy-coded contrast (0 for WLC, 1 for MM). The model adjusted for change at weeks 4 and 12 of the study, and for a subject's number of symptoms at baseline.||0.24|-0.30|0.90
72410247|NCT03224468|144328802|SUPERIORITY|Power was determined to be 83.6% using a Monte Carlo simulation approach in which data were simulated from a multi-level linear regression model with a subject-varying random intercept, a shared baseline across WLC and MMC, and fixed effects for a change over each time point. Simulated data were fit with a linear model estimated via GEE - simulations were repeated 1000 times and power was estimated as the proportion where the contrast between WLC and MM had p\<0.05.|Mean Difference (Net)|0.02|STANDARD_ERROR_OF_MEAN|0.5||0.93|TWO_SIDED|95.0|-0.38|0.39||The p-value is adjusted for multiple comparisons using per Benjamini \& Hochberg (1995) across the five primary outcome measures. Effects were deemed significant for p\<0.05.|Regression, Linear|Estimates were obtained using generalized estimating equations (GEE) with robust standard errors obtained by the sandwich estimator.|Estimate is the mean difference in number of symptoms for MM above and beyond WLC (positive values denote higher number of symptoms for MM).|The mean difference in number of symptoms between the MM and WLC groups was estimated via a linear model with a dummy-coded contrast (0 for WLC, 1 for MM). The model adjusted for change at weeks 4 and 12 of the study, and for a subject's number of symptoms at baseline.||0.39|-0.38|0.93
72480410|NCT03442985|144487226|OTHER||Risk Ratio (RR)|1.003||||0.9918|TWO_SIDED|95.0|0.592|1.699||The p-values were not adjusted for multiple testing due to small sample size. The correlation matrix type = compound symmetry was used.|Negative binomial regression model|||Palovarotene 2.5 mg vs Placebo: The annualized rate for number of new or worsening deformities was estimated using an unadjusted negative binomial regression model, offsetted by log-transformed follow-up time (years) to obtain annualized rate.||1.699|0.592|0.9918
72480411|NCT03442985|144487226|OTHER||Risk Ratio (RR)|1.055||||0.7997|TWO_SIDED|95.0|0.7|1.589||The p-values were not adjusted for multiple testing due to small sample size. The correlation matrix type = compound symmetry was used.|Negative binomial regression model|||Palovarotene 5.0 mg vs Placebo: The annualized rate for number of new or worsening deformities was estimated using an unadjusted negative binomial regression model, offsetted by log-transformed follow-up time (years) to obtain annualized rate.||1.589|0.700|0.7997
72480412|NCT03442985|144487227|OTHER||Risk Ratio (RR)|1.548||||0.2186|TWO_SIDED|95.0|0.772|3.108||The p-values were not adjusted for multiple testing due to small sample size. The correlation matrix type = independent was used.|Poisson regression model|||Palovarotene 2.5 mg vs Palovarotene 5.0 mg: The annualized rate for number of MO-related surgeries was estimated using an unadjusted poisson regression model, offsetted by log-transformed follow-up time (years) to obtain annualized rate.||3.108|0.772|0.2186
72480413|NCT03442985|144487227|OTHER||Risk Ratio (RR)|1.655||||0.27|TWO_SIDED|95.0|0.676|4.052||The p-values were not adjusted for multiple testing due to small sample size. The correlation matrix type = independent was used.|Poisson regression model|||Palovarotene 2.5 mg vs Placebo: The annualized rate for number of MO-related surgeries was estimated using an unadjusted poisson regression model, offsetted by log-transformed follow-up time (years) to obtain annualized rate.||4.052|0.676|0.2700
72480414|NCT03442985|144487227|OTHER||Risk Ratio (RR)|1.069||||0.8546|TWO_SIDED|95.0|0.524|2.178||The p-values were not adjusted for multiple testing due to small sample size. The correlation matrix type = independent was used.|Poisson regression model|||Palovarotene 5.0 mg vs Placebo: The annualized rate for number of MO-related surgeries was estimated using an unadjusted poisson regression model, offsetted by log-transformed follow-up time (years) to obtain annualized rate.||2.178|0.524|0.8546
72480415|NCT03339570|144487257|SUPERIORITY||Mean Difference (Final Values)|18.3|||<|0.01|TWO_SIDED||||||t-test, 2 sided|||Student's t test was used if they were variables adjusted to a normal distribution, or the Mann-Whitney U test if they were non-normal variables.||||<0.01
72480416|NCT00679627|144487287|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANCOVA|||||||<0.001
72510021|NCT05372575|144550708|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|21.22|||||TWO_SIDED|95.0|8.65|52.07|||||GMR=(GMT of 13vPnC VT- or Sp- Subgroup)/(GMT of non-13vPnC VT- or Sp- Subgroup)|GMR of 13vPnC Cohort/non-13vPnC Cohort in VT- or Sp- Subgroups for Serotype: 7F||52.07|8.65|
72401002|NCT03971695|144309248|OTHER||Adjusted geometric mean (gMean) ratio(%)|100.26|||||TWO_SIDED|90.0|90.18|111.48|||||Intra-individual geometric coefficient of variance (gCV) = 14.2. Ratio is T1/R.|Analysis of variance (ANOVA) on the logarithmic scale including effects for 'sequence', 'subjects nested within sequences', 'period', and 'treatment'. Confidence intervals were calculated based on the residual error from the ANOVA.||111.48|90.18|
72401003|NCT03971695|144309248|OTHER||Adjusted geometric mean (gMean) ratio(%)|91.63|||||TWO_SIDED|90.0|85.37|98.35|||||Intra-individual geometric coefficient of variance (gCV) = 9.5. Ratio is T2/T1.|Analysis of variance (ANOVA) on the logarithmic scale including effects for 'sequence', 'subjects nested within sequences', 'period', and 'treatment'. Confidence intervals were calculated based on the residual error from the ANOVA.||98.35|85.37|
72480417|NCT00679627|144487288|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.58||||0.011|TWO_SIDED|95.0|0.37|0.89|||Regression, Cox|||||0.89|0.37|0.011
72480418|NCT00679627|144487289|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANCOVA|||||||<0.001
72480419|NCT00679627|144487290|SUPERIORITY_OR_OTHER|||||||0.002|||||||ANCOVA|||||||0.002
72480420|NCT00679627|144487293|SUPERIORITY_OR_OTHER|||||||0.269||||||Baseline|Cochran-Mantel-Haenszel|||||||0.269
72480421|NCT00679627|144487293|SUPERIORITY_OR_OTHER|||||||0.835||||||Month 24|Cochran-Mantel-Haenszel|||||||0.835
72480422|NCT00679627|144487294|SUPERIORITY_OR_OTHER|||||||0.194||||||Orientation subscale|ANCOVA|||||||0.194
72480423|NCT00679627|144487294|SUPERIORITY_OR_OTHER|||||||0.353||||||Registration subscale|ANCOVA|||||||0.353
72480424|NCT00679627|144487294|SUPERIORITY_OR_OTHER|||||||0.009||||||Attention and Calculation subscale|ANCOVA|||||||0.009
72480425|NCT00679627|144487294|SUPERIORITY_OR_OTHER|||||||0.158||||||Recall subscale|ANCOVA|||||||0.158
72480426|NCT00679627|144487294|SUPERIORITY_OR_OTHER|||||||0.088||||||Language subscale|ANCOVA|||||||0.088
72480427|NCT00679627|144487295|SUPERIORITY_OR_OTHER|||||||0.01||||||Initiation subscale|ANCOVA|||||||0.010
72480428|NCT00679627|144487295|SUPERIORITY_OR_OTHER|||||||0.043||||||Planning and Organization subscale|ANCOVA|||||||0.043
72480429|NCT00679627|144487295|SUPERIORITY_OR_OTHER|||||||0.018||||||Effective Performance subscale|ANCOVA|||||||0.018
72480430|NCT00679627|144487295|SUPERIORITY_OR_OTHER|||||||0.005||||||Basic subscale|ANCOVA|||||||0.005
72480431|NCT00679627|144487295|SUPERIORITY_OR_OTHER|||||||0.054||||||Instrumental subscale|ANCOVA|||||||0.054
72480432|NCT00679627|144487295|SUPERIORITY_OR_OTHER|||||||0.137||||||Leisure subscale|ANCOVA|||||||0.137
72480433|NCT01886378|144487296|SUPERIORITY||Least squares (LS) mean|423.594||||0.1518|TWO_SIDED|95.0|-155.66|1002.85||The GEE model included the change from Baseline for each parameter as the dependent variable, time as the categorical variable, and adjusted for Baseline measurement with compound symmetry covariance structure.|GEE model||LS Mean, 95% confidence interval (CI), and p-values are based on the GEE model.|||1002.85|-155.66|0.1518
72480434|NCT01886378|144487297|SUPERIORITY||LS mean|-0.011||||0.3964|TWO_SIDED|95.0|-0.04|0.01||The GEE model included the change from Baseline for each parameter as the dependent variable, time as the categorical variable, and adjusted for Baseline measurement with compound symmetry covariance structure.|GEE model||LS Mean, 95% CI, and p-values are based on the GEE model.|||0.01|-0.04|0.3964
72401004|NCT03971695|144309249|OTHER||Adjusted geometric mean (gMean) ratio(%)|98.01|||||TWO_SIDED|90.0|84.2|114.08|||||Intra-individual geometric coefficient of variance (gCV) = 20.5. Ratio is T1/R.|Analysis of variance (ANOVA) on the logarithmic scale including effects for 'sequence', 'subjects nested within sequences', 'period', and 'treatment'. Confidence intervals were calculated based on the residual error from the ANOVA.||114.08|84.20|
72401005|NCT03971695|144309249|OTHER||Adjusted geometric mean (gMean) ratio(%)|77.52|||||TWO_SIDED|90.0|68.11|88.22|||||Intra-individual geometric coefficient of variance (gCV) = 17.4. Ratio is T2/T1.|Analysis of variance (ANOVA) on the logarithmic scale including effects for 'sequence', 'subjects nested within sequences', 'period', and 'treatment'. Confidence intervals were calculated based on the residual error from the ANOVA.||88.22|68.11|
72401006|NCT03971695|144309253|OTHER||Adjusted geometric mean (gMean) ratio(%)|96.42|||||TWO_SIDED|90.0|86.96|106.9|||||Intra-individual geometric coefficient of variance (gCV) = 13.9. Ratio is T1/R.|Analysis of variance (ANOVA) on the logarithmic scale including effects for 'sequence', 'subjects nested within sequences', 'period', and 'treatment'. Confidence intervals were calculated based on the residual error from the ANOVA.||106.90|86.96|
72401007|NCT03971695|144309253|OTHER||Adjusted geometric mean (gMean) ratio(%)|91.27|||||TWO_SIDED|90.0|85.4|97.54|||||Intra-individual geometric coefficient of variance (gCV) = 8.9. Ratio is T2/T1.|Analysis of variance (ANOVA) on the logarithmic scale including effects for 'sequence', 'subjects nested within sequences', 'period', and 'treatment'. Confidence intervals were calculated based on the residual error from the ANOVA.||97.54|85.40|
72401008|NCT01280552|144309260|SUPERIORITY_OR_OTHER|||||||0.01|TWO_SIDED|||||Stratified for age and MGMT methylation status|Log Rank|||Stratified log rank p value stratified for age and MGMT methylation status||||0.010
72401009|NCT01280552|144309262|SUPERIORITY_OR_OTHER|||||||0.033|TWO_SIDED|||||Analyses were stratified for age and MGMT methylation status.|Log Rank|||||||0.033
72401010|NCT02155738|144309263|SUPERIORITY||||||<|0.05|||||||Mixed Models Analysis|||Aim 1: Quantify the impact of IV acetaminophen on 1a) postoperative pain scores ... 1a) To achieve this aim, we will measure the degree of postoperative pain using visual analog scales (VAS) at multiple specified time points throughout the postoperative period; we report on change from Baseline VAS at 24 Hours Postop. Null Hypothesis is that there is no difference between subgroups in VAS scores. Sample size was determined considering significant differences in VAS scores.||||<0.05
72401011|NCT02155738|144309264|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|||1b) We will use equianalgesic dosage tables to convert intra- and postoperative narcotics into morphine equivalents to compare narcotic requirements for the first week after surgery. We hypothesize that those patients receiving preemptive IV acetaminophen will have lower postoperative VAS scores and reduced narcotic requirements compared to placebo.||||<0.05
72401012|NCT02603809|144309266|OTHER||||||<|0.001|||||||Multiple Comparison Procedure-Modeling|||"Multiple Comparison Procedure-Modeling (MCP-Mod) was used to assess a dose-response across placebo and all aprocitentan doses. The null hypothesis of no dose-response was rejected if at least one of the six Multiple Contrast Tests (MCTs) had a multiplicity adjusted p-value \<0.05. The analysis was performed using the R-package DoseFinding (Bornkamp B, Pinheiro J, Bretz F. Planning and analyzing dose finding experiments. 2016. Available from: cran.r-projects.org/web/packages/DoseFinding.)"||||<0.001
72401013|NCT02603809|144309266|SUPERIORITY||LS Mean|-1.31|STANDARD_ERROR_OF_MEAN|1.548||0.8117|TWO_SIDED|95.0|-5.1|2.49|||ANCOVA|with Dunnett correction.||||2.49|-5.10|0.8117
72401014|NCT02603809|144309266|SUPERIORITY||LS Mean|-4.93|STANDARD_ERROR_OF_MEAN|1.532||0.0053|TWO_SIDED|95.0|-8.68|-1.17|||ANCOVA|with Dunnett correction.||||-1.17|-8.68|0.0053
72510022|NCT05372575|144550708|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|23.73|||||TWO_SIDED|95.0|10.39|54.19|||||GMR=(GMT of 13vPnC VT- or Sp- Subgroup)/(GMT of non-13vPnC VT- or Sp- Subgroup)|GMR of 13vPnC Cohort/non-13vPnC Cohort in VT- or Sp- Subgroups for Serotype: 9V||54.19|10.39|
72401015|NCT02603809|144309266|SUPERIORITY||LS Mean|-6.99|STANDARD_ERROR_OF_MEAN|1.554|<|0.0001|TWO_SIDED|95.0|-10.8|-3.19|||ANCOVA|with Dunnett correction.||||-3.19|-10.80|<.0001
72401016|NCT02603809|144309266|SUPERIORITY||LS Mean|-4.95|STANDARD_ERROR_OF_MEAN|1.549||0.0057|TWO_SIDED|95.0|-8.75|-1.15|||ANCOVA|with Dunnett correction.||||-1.15|-8.75|0.0057
72401017|NCT02603809|144309267|OTHER||||||<|0.001|||||||Multiple Comparison Procedure-Modeling|||"Multiple Comparison Procedure-Modeling (MCP-Mod) was used to assess a dose-response across placebo and all aprocitentan doses. The null hypothesis of no dose-response was rejected if at least one of the six Multiple Contrasts Tests (MCTs) had a multiplicity adjusted p-value \<0.05. The analysis was performed using the R-package DoseFinding (Bornkamp B, Pinheiro J, Bretz F. Planning and analyzing dose finding experiments. 2016. Available from: cran-rprojects.org/web/packages/DoseFinding.)"||||<0.001
72401018|NCT02603809|144309267|SUPERIORITY||LS Mean|-2.45|STANDARD_ERROR_OF_MEAN|2.445||0.7071|TWO_SIDED|95.0|-8.44|3.54|||ANCOVA|with Dunnett correction.||||3.54|-8.44|0.7071
72401019|NCT02603809|144309267|SUPERIORITY||LS Mean|-7.05|STANDARD_ERROR_OF_MEAN|2.42||0.0138|TWO_SIDED|95.0|-12.98|-1.12|||ANCOVA|with Dunnett correction.||||-1.12|-12.98|0.0138
72401020|NCT02603809|144309267|SUPERIORITY||LS Mean|-9.9|STANDARD_ERROR_OF_MEAN|2.457||0.0003|TWO_SIDED|95.0|-15.92|-3.88|||ANCOVA|with Dunnett correction.||||-3.88|-15.92|0.0003
72401021|NCT02603809|144309267|SUPERIORITY||LS Mean|-7.58|STANDARD_ERROR_OF_MEAN|0.0077||0.0077|TWO_SIDED|95.0|-13.58|-1.59|||ANCOVA|with Dunnett correction.||||-1.59|-13.58|0.0077
72401022|NCT02603809|144309273|OTHER||||||<|0.001|||||||Multiple Comparison Procedure-Modeling|||"Multiple Comparison Procedure-Modeling (MCP-Mod) was used to assess a dose-response across placebo and all aprocitentan doses. The null hypothesis of no dose-response was rejected if at least one of the six Multiple Contrast Tests (MCTs) had a multiplicity adjusted p-value \<0.05. The analysis was performed using the R-package DoseFinding (Bornkamp B, Pinheiro J, Bretz F. Planning and analyzing dose finding experiments. 2016. Available from: cran.r-projects.org/web/packages/DoseFinding.)"||||<0.001
72401023|NCT02603809|144309273|SUPERIORITY||LS Mean|-1.75|STANDARD_ERROR_OF_MEAN|1.401||0.5356|TWO_SIDED|95.0|-5.19|1.69|||ANCOVA|with Dunnett correction.||||1.69|-5.19|0.5356
72401024|NCT02603809|144309273|SUPERIORITY||LS Mean|-5.82|STANDARD_ERROR_OF_MEAN|1.396||0.0001|TWO_SIDED|95.0|-9.25|-2.4|||ANCOVA|with Dunnett correction.||||-2.40|-9.25|0.0001
72401025|NCT02603809|144309273|SUPERIORITY||LS Mean|-7.5|STANDARD_ERROR_OF_MEAN|1.41|<|0.0001|TWO_SIDED|95.0|-10.96|-4.04|||ANCOVA|with Dunnett correction.||||-4.04|-10.96|<.0001
72401026|NCT02603809|144309273|SUPERIORITY||LS Mean|-5.65|STANDARD_ERROR_OF_MEAN|1.41||0.0003|TWO_SIDED|95.0|-9.11|-2.19|||ANCOVA|with Dunnett correction.||||-2.19|-9.11|0.0003
72401027|NCT01010906|144309274|NON_INFERIORITY_OR_EQUIVALENCE|If the 90% Confidence Interval falls within the interval \[0.50, 2.00\], then treatment of HI participants is similar to treatment of healthy matched for mild HI participants.|Geometric Least-Square Mean Ratio|1.82|||||TWO_SIDED|90.0|0.96|3.43||||||||3.43|0.96|
72401028|NCT01010906|144309274|NON_INFERIORITY_OR_EQUIVALENCE|If the 90% Confidence Interval falls within the interval \[0.50, 2.00\], then treatment of HI participants is similar to treatment of healthy matched for moderate HI participants.|Geometric Least-Square Mean Ratio|3.11|||||TWO_SIDED|90.0|1.6|6.04||||||||6.04|1.60|
72401029|NCT01010906|144309274|NON_INFERIORITY_OR_EQUIVALENCE|If the 90% Confidence Interval falls within the interval \[0.50, 2.00\], then treatment of HI participants is similar to treatment of healthy matched for severe HI participants.|Geometric Least-Square Mean Ratio|8.42|||||TWO_SIDED|90.0|5.2|13.64||||||||13.64|5.20|
72401030|NCT01010906|144309275|SUPERIORITY_OR_OTHER||Geometric Least-Square Mean Ratio|1.57|||||TWO_SIDED|90.0|0.76|3.24||||||||3.24|0.76|
72401031|NCT01010906|144309275|SUPERIORITY_OR_OTHER||Geometric Least-Square Mean Ratio|2.21|||||TWO_SIDED|90.0|1.21|4.03||||||||4.03|1.21|
72623927|NCT00721110|144778299|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.93||||0.96|TWO_SIDED|97.5|-52.0|54.0||Significant if P \< 0.003 for efficacy and P \> 0.5311 for futility; 97.5% confidence intervals adjusted for group sequential design to maintain the overall alpha of 0.025 for each primary intervention.|ANCOVA|Adjusted for baseline 6-minute walk distance||The effect of lidocaine on 6-minute walk distance on the 2nd postoperative morning was assessed using analysis of covariance. We expected the control group's mean 6-minute walk distance to be 300 meters with a standard deviation (SD) of about 20% of the mean for each group. Assuming a correlation of 0.5 between baseline and 2nd postoperative day, a maximum 128 total patients (32 for each group) was needed to have 80% power at the 0.025 significance level to detect effects of 36 meters or more.||54|-52|0.96
72401032|NCT01010906|144309275|SUPERIORITY_OR_OTHER||Geometric Least-Square Mean Ratio|6.16|||||TWO_SIDED|90.0|3.9|9.71||||||||9.71|3.90|
72401033|NCT00525174|144309278|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||Regression, Logistic|||Logistic regression was performed comparing the proportions of patients in each treatment group who had no improvement or worsening in amblyopic eye visual acuity from baseline to 24 weeks (change from baseline \<= +4 letters for E-ETDRS testing).||||0.02
72401034|NCT00525174|144309279|NON_INFERIORITY_OR_EQUIVALENCE|The trial was designed as a non-inferiority study. The sample size was computed to be 170 subjects to have 90% power and a type I error rate of 5% for a noninferiority limit of 0.075 logarithm of minimum angle of resolution (logMAR), based on assumed standard deviation of 24-week visual acuity scores of 0.16 logMAR, a correlation between baseline and final acuities of 0.20, and 10% noncompletion of the study primary outcome examination.|Mean Difference (Net)|0.38|||||ONE_SIDED|95.0||0.76|||ANCOVA|The logMAR visual acuity scores were adjusted for baseline amblyopic eye acuity.||The trial was designed as a non-inferiority study. The sample size was computed to be 170 subjects to have 90% power and a type I error rate of 5% for a noninferiority limit of 0.075 logarithm of minimum angle of resolution (logMAR), based on assumed standard deviation of 24-week visual acuity scores of 0.16 logMAR, a correlation between baseline and final acuities of 0.20, and 10% noncompletion of the study primary outcome examination.||0.76||
72401035|NCT00525174|144309279|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.38||||0.09|TWO_SIDED|95.0|-0.06|0.83|||ANCOVA|The logMAR visual acuity scores were adjusted for baseline amblyopic eye acuity.||In addition to the test of non-inferiority, an efficacy test of Patching over Bangerter filters was also completed.||0.83|-0.06|0.09
72401036|NCT00525174|144309279|SUPERIORITY_OR_OTHER|||||||0.2||95.0|||||Mixed Models Analysis|||Treatment group difference in rate of improvement was evaluated using a population averaged linear mixed model after performing an inverse transformation of time to obtain linearity.||||0.20
72623928|NCT00721110|144778299|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.0||||0.54|TWO_SIDED|97.5|-65.0|44.0||97.5% confidence interval adjusted for group sequential design (using confidence coefficient of 2.97) to maintain theoverall α of 0.025 for each primary intervention and 0.05 for the trial.|ANCOVA|Adjusted for baseline 6-minute walk distance||The effect of ketamine on 6-minute walk distance on the 2nd postoperative morning was assessed using analysis of covariance. We expected the control group's mean 6-minute walk distance to be 300 meters with a standard deviation (SD) of about 20% of the mean for each group. Assuming a correlation of 0.5 between baseline and 2nd postoperative day, a maximum 128 total patients (32 for each group) was needed to have 80% power at the 0.025 significance level to detect effects of 36 meters or more.||44|-65|0.54
72623929|NCT00721110|144778300|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0||||0.2|TWO_SIDED|97.5|-3.3|1.3||97.5% confidence intervals (CIs) adjusted for group sequential design (using confidence coefficient of 2.97) to maintain the overall α of 0.025 for each intervention and 0.05 for the trial.|t-test, 2 sided|||Groups compared on VRS scores at PACU admit using a t test.||1.3|-3.3|0.20
72401037|NCT00525174|144309279|SUPERIORITY_OR_OTHER|||||||0.49||95.0|||||ANCOVA|||The relationship between the fellow eye blur from the Bangerter filter at baseline and amblyopic improvement at the 24-week outcome was evaluated with an ANCOVA model with acuity in the fellow eye being categorized as better than versus equal to or worse than acuity in the amblyopic eye.||||0.49
72401038|NCT00525174|144309279|SUPERIORITY_OR_OTHER|||||||0.21||95.0|||||ANCOVA|||The association of fixation preference while the Bangerter filter was over the fellow eye at baseline (amblyopic eye, fellow eye, alternates) with 24-week amblyopic eye acuity was evaluated in an ANCOVA model.||||0.21
72401039|NCT00525174|144309281|SUPERIORITY_OR_OTHER|||||||0.27||95.0|||||Regression, Logistic|||Logistic regression was used to compare the proportion of patients in each treatment group with amblyopic eye visual acuity within 1 line of the fellow eye or better.||||0.27
72401040|NCT00525174|144309282|SUPERIORITY_OR_OTHER|||||||0.86||95.0|||||Regression, Logistic|||Logistic regression was used to compare the proportion of patients in each treatment group with amblyopic visual acuity 20/25 or better at 24 weeks.||||0.86
72401041|NCT00525174|144309282|SUPERIORITY_OR_OTHER|||||||0.28||95.0|||||Regression, Cox|||The time to first achieve amblyopic eye visual acuity of 20/25 or better was evaluated using a Cox proportional hazard model.||||0.28
72401042|NCT00525174|144309283|SUPERIORITY_OR_OTHER|||||||0.61||95.0|||||Regression, Logistic|||Logistic regression was used to compare the proportion of patients with 3 or more lines of amblyopic eye visual acuity improvement from baseline to 24 weeks.||||0.61
72401043|NCT00525174|144309286|SUPERIORITY_OR_OTHER|||||||0.9||95.0|||||Wilcoxon rank-sum|||A Wilcoxon rank-sum test was used to evaluate change in Randot Preschool stereoacuity levels from baseline to 24 weeks by treatment group.||||0.90
72401044|NCT00525174|144309287|SUPERIORITY_OR_OTHER|||||||0.88||95.0|||||Wilcoxon rank-sum|||A Wilcoxon rank-sum test was used to evaluate change in Randot Preschool stereoacuity levels from baseline to 24 weeks by treatment group.||||0.88
72401045|NCT00525174|144309289|SUPERIORITY_OR_OTHER|||||||0.07||95.0|||||ANCOVA|||A treatment group difference in the fellow eye visual acuity at 24 weeks was evaluated in an ANCOVA model adjusted for the baseline fellow eye acuity.||||0.07
72401046|NCT00525174|144309289|SUPERIORITY_OR_OTHER|||||||0.21||95.0|||||Fisher Exact|||The Fisher exact test was used to compare the proportion of subjects in each treatment group who tested 2 or more logMAR lines worse in the fellow eye at 24 weeks compared with baseline.||||0.21
72576862|NCT00261443|144680664|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.22||||0.196|TWO_SIDED|95.0|-0.54|0.11||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 20 Comparison||0.11|-0.54|0.196
72401047|NCT00525174|144309290|SUPERIORITY_OR_OTHER|||||||0.03||95.0|||||t-test, 2 sided|||A t-test was used to evaluate treatment group difference of impact of treatment at 6 weeks.||||0.03
72401048|NCT00525174|144309291|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||A t-test was used to evaluate treatment group difference of impact of treatment at 24 weeks.||||<0.001
72401049|NCT00525174|144309292|SUPERIORITY_OR_OTHER|||||||0.9||95.0|||||t-test, 2 sided|||A t-test was used to evaluate treatment group difference of the adverse effects subscale at 6 weeks.||||0.90
72401050|NCT00525174|144309293|SUPERIORITY_OR_OTHER|||||||0.01||95.0|||||t-test, 2 sided|||A t-test was used to evaluate treatment group difference of the adverse effects subscale at 24 weeks.||||0.01
72401051|NCT00525174|144309294|SUPERIORITY_OR_OTHER|||||||0.12||95.0|||||t-test, 2 sided|||A t-test was used to evaluate treatment group difference of the compliance subscale at 6 weeks.||||0.12
72401052|NCT00525174|144309295|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||t-test, 2 sided|||A t-test was used to evaluate treatment group difference of the compliance subscale at 24 weeks.||||0.001
72401053|NCT00525174|144309296|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||A t-test was used to evaluate treatment group difference of social stigma at 6 weeks.||||<0.001
72401054|NCT00525174|144309297|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||A t-test was used to evaluate treatment group difference of social stigma at 24 weeks.||||<0.001
72401055|NCT03453684|144309299|OTHER||Overall SE of the estimate|0.009|||||TWO_SIDED||||||||Standard error of the estimate of Typical value: 0.45 Standard error of the estimate of w\^2: 0.39|||||
72401056|NCT03453684|144309300|OTHER||Overall Standard Error of the Estimate|9.85|||||TWO_SIDED||||||||Standard error of the estimate of Typical value: 0.61 Standard error of the estimate of ꙍ\^2 (intersubject variability): \^a (fixed to 0)|||||
72401057|NCT03453684|144309301|OTHER||Overall Standard Error of the Estimate|8.37|||||TWO_SIDED||||||||Standard error of the estimate of Typical value: 0.02 Standard error of the estimate of ꙍ\^2 (intersubject variability): \^a (fixed to 0)|||||
72401058|NCT03453684|144309302|OTHER||Overall Standard Error of the Estimate|4.83|||||TWO_SIDED||||||||Standard error of the estimate of Typical value: 0.003 Standard error of the estimate of ꙍ\^2 (intersubject variability): 0.03|||||
72401059|NCT03453684|144309303|OTHER||Overall Standard Error of the Estimate|17.21|||||TWO_SIDED||||||||Standard error of the estimate of Typical value: 0.13|||||
72401060|NCT03453684|144309304|OTHER||SE of the estimate of Typical Value|0.2|||||TWO_SIDED|||||||||||||
72401061|NCT03453684|144309305|OTHER||SE of the estimate of Typical Value|2.1|||||TWO_SIDED||||||||Standard error of the estimate of Typical value should be read as: 2.1E-06 Standard error of the estimate of ꙍ\^2 (intersubject variability): 0.24|||||
72401062|NCT03453684|144309306|OTHER||SE of the estimate of Typical Value|2.3|||||TWO_SIDED||||||||Standard error of the estimate of ꙍ\^2 (intersubject variability): 0.08|||||
72401063|NCT03453684|144309307|OTHER||Overall Standard Error of the Estimate|10.8|||||TWO_SIDED||||||||Standard error of the estimate of Typical value: 0.02|||||
72401064|NCT03453684|144309308|OTHER||SE of the estimate of Typical Value|0.9|||||TWO_SIDED|||||||||||||
72401065|NCT00751348|144309360|NON_INFERIORITY|Criterion for evaluation of non-inferiority: the lower limit (LL) of the two-sided standardized asymptotic 95% confidence interval (CI) for the group difference (Priorix-Tetra Group minus Priorix+Varilrix Group) in seroconversion rate for anti-measles was above -10%.|Difference in percentage|-1.36|||<|0.05|TWO_SIDED|95.0|-3.77|1.66||The P-value for all reactogenicity comparisons was below (\<) 0.05.|Fisher Exact|||Non-inferiority of Priorix-Tetra® vaccine vs Priorix™ and Varilrix™ administered as concomitant vaccine 42-56 days after vaccination at Day 0 in terms of anti-measles seroconversion rates.||1.66|-3.77|<0.05
72480435|NCT01886378|144487298|SUPERIORITY||LS mean|4.671||||0.0777|TWO_SIDED|95.0|-0.52|9.86||The GEE model included the change from Baseline for each parameter as the dependent variable, time as the categorical variable, and adjusted for Baseline measurement with compound symmetry covariance structure.|GEE model||LS Mean, 95% CI, and p-values are based on the GEE model.|||9.86|-0.52|0.0777
72401066|NCT00751348|144309360|NON_INFERIORITY|Criterion for evaluation of non-inferiority: the lower limit (LL) of the two-sided standardized asymptotic 95% confidence interval (CI) for the group difference (Priorix-Tetra Group minus Priorix+Varilrix Group) in seroconversion rate for anti-mumps was above -10%.|Difference in percentage|-5.34|||<|0.05|TWO_SIDED|95.0|-10.4|0.38||The P-value for all reactogenicity comparisons was below (\<) 0.05.|Fisher Exact|||Non-inferiority of Priorix-Tetra® vaccine vs Priorix™ and Varilrix™ administered as concomitant vaccine 42-56 days after vaccination at Day 0 in terms of anti-mumps seroconversion rates.||0.38|-10.4|<0.05
72401067|NCT00751348|144309360|NON_INFERIORITY|Criterion for evaluation of non-inferiority: the lower limit (LL) of the two-sided standardized asymptotic 95% confidence interval (CI) for the group difference (Priorix-Tetra Group minus Priorix+Varilrix Group) in seroconversion rate for anti-rubella was above -10%.|Difference in percentage|-0.34|||<|0.05|TWO_SIDED|95.0|-1.88|2.06||The P-value for all reactogenicity comparisons was below (\<) 0.05.|Fisher Exact|||Non-inferiority of Priorix-Tetra® vaccine vs Priorix™ and Varilrix™ administered as concomitant vaccine 42-56 days after vaccination at Day 0 in terms of anti-rubella seroconversion rates.||2.06|-1.88|<0.05
72510023|NCT05372575|144550708|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|12.84|||||TWO_SIDED|95.0|5.46|30.22|||||GMR=(GMT of 13vPnC VT- or Sp- Subgroup)/(GMT of non-13vPnC VT- or Sp- Subgroup)|GMR of 13vPnC Cohort/non-13vPnC Cohort in VT- or Sp- Subgroups for Serotype: 14||30.22|5.46|
72480436|NCT01886378|144487299|SUPERIORITY||LS mean|181.37||||0.083|TWO_SIDED|95.0|-23.7|386.45||The GEE model included the change from Baseline for each parameter as the dependent variable, time as the categorical variable, and adjusted for Baseline measurement with compound symmetry covariance structure.|GEE model||LS Mean, 95% CI, and p-values are based on the GEE model.|||386.45|-23.70|0.0830
72480437|NCT01886378|144487300|SUPERIORITY||LS mean|-0.185||||0.032|TWO_SIDED|95.0|-0.35|-0.02||The GEE model included the change from Baseline for each parameter as the dependent variable, time as the categorical variable, and adjusted for Baseline measurement with compound symmetry covariance structure.|GEE model||LS Mean, 95% CI, and p-values are based on the GEE model.|||-0.02|-0.35|0.0320
72480438|NCT01886378|144487301|SUPERIORITY||LS mean|12.44||||0.085|TWO_SIDED|95.0|-1.72|26.6||The GEE model included the change from Baseline for each parameter as the dependent variable, time as the categorical variable, and adjusted for Baseline measurement with compound symmetry covariance structure.|GEE model||LS Mean, 95% CI, and p-values are based on the GEE model.|||26.60|-1.72|0.0850
72480439|NCT01886378|144487302|SUPERIORITY||LS mean|2.16||||0.3754|TWO_SIDED|95.0|-2.62|6.94||The LS Mean, standard error (SE), 95% CI, and 2-sided p-value are from the GEE model.|GEE model|||||6.94|-2.62|0.3754
72480440|NCT01886378|144487303|SUPERIORITY||LS mean|0.816||||0.7564|TWO_SIDED|95.0|-4.34|5.97||The LS Mean, SE, 95% CI, and 2-sided p-value are from the GEE model.|GEE model|||||5.97|-4.34|0.7564
72480441|NCT01886378|144487304|SUPERIORITY||LS mean|8.88|||<|0.0001|TWO_SIDED|95.0|5.67|12.08||The GEE model included the change from Baseline for each parameter as the dependent variable, time as the categorical variable, and adjusted for Baseline measurement with compound symmetry covariance structure.|GEE model|||||12.08|5.67|<0.0001
72401068|NCT00751348|144309360|NON_INFERIORITY|Criterion for evaluation of non-inferiority: the lower limit (LL) of the two-sided standardized asymptotic 95% confidence interval (CI) for the group difference (Priorix-Tetra Group minus Priorix+Varilrix Group) in seroconversion rate for anti-VZV was above -10%.|Difference in percentage|-1.06|||<|0.05|TWO_SIDED|95.0|-3.07|1.44||The P-value for all reactogenicity comparisons was below (\<) 0.05.|Fisher Exact|||Non-inferiority of Priorix-Tetra® vaccine vs Priorix™ and Varilrix™ administered as concomitant vaccine 42-56 days after vaccination at Day 0 in terms of anti-varicella zoster virus (anti-VZV) seroconversion rates.||1.44|-3.07|<0.05
72480442|NCT01886378|144487305|SUPERIORITY||LS mean|9.7||||0.0152|TWO_SIDED|95.0|1.87|17.54||The GEE model included the change from Baseline for each parameter as the dependent variable, time as the categorical variable, and adjusted for Baseline measurement with compound symmetry covariance structure.|GEE model||LS Mean, 95% CI, and p-values are based on the GEE model.|||17.54|1.87|0.0152
72480443|NCT03021954|144487323|SUPERIORITY|||||||0.086|||||||Wilcoxon (Mann-Whitney)|||The null hypothesis is in the intervention group, we expect a decrease in the area of the levator hiatus at 40 days and 3 months post-partum. Power 90 % confidence interval β = 0.10, α = 0.05||||0.086
72480444|NCT03021954|144487324|EQUIVALENCE|||||||0.29|||||||Wilcoxon (Mann-Whitney)|||The null hypothesis is platelet rich plasma can maintain or increase levator ani muscle contractions post-partum||||0.29
72480445|NCT02594826|144487353|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|35.8|||<|0.001|TWO_SIDED|95.0|11.1|114.9|||Mixed Models Analysis|This is the calculated p-value, which is adjusted for age, marital status, prior screening, health insurance, and having a healthcare provider.||||114.9|11.1|<0.001
72480446|NCT02594826|144487354|SUPERIORITY|||||||0.005|||||||Regression, Linear|Controlling for: marital status, education, language spoken at home, health insurance, regular physician, language of physician, ever had Pap test.||The null hypothesis is that the two conditions would not differ in their knowledge following program participation. The study biostatistician conducted full regression models to examine change in knowledge (from pre- to post-program) within each group and across groups over time. The models controlled for relevant covariates.||||0.005
72510024|NCT05372575|144550708|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|12.88|||||TWO_SIDED|95.0|5.95|27.88|||||GMR=(GMT of 13vPnC VT- or Sp- Subgroup)/(GMT of non-13vPnC VT- or Sp- Subgroup)|GMR of 13vPnC Cohort/non-13vPnC Cohort in VT- or Sp- Subgroups for Serotype: 18C||27.88|5.95|
72480447|NCT03581825|144487355|SUPERIORITY|Statistically superiority was concluded if the lower limit of the confidence intervals of the Test lens are greater than 40 points.|Least-Square Mean|56.3|STANDARD_ERROR_OF_MEAN|2.55|||TWO_SIDED|95.0|51.2|61.4|||Linear Mixed Model|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.||||61.4|51.2|
72480448|NCT03581825|144487356|NON_INFERIORITY|The non-inferiority of the Test lens relative to the Control was concluded if the lower confidence limit of LSM difference was above the non-inferiority margin -5.|Least-Square Mean Difference|3.4|STANDARD_ERROR_OF_MEAN|2.0|||TWO_SIDED|95.0|-0.5|7.4|||Linear Mixed Model|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.|Mean Difference was calculated as Test minus Control|||7.4|-0.5|
72623930|NCT00721110|144778300|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5||||0.54|TWO_SIDED|97.5|-2.8|1.9||97.5% confidence intervals (CIs) adjusted for group sequential design (using confidence coefficient of 2.97) to maintain the overall α of 0.025 for each intervention and 0.05 for the trial.|t-test, 2 sided|||Ketamine compared to placebo at PACU admit using a t test||1.9|-2.8|0.54
72623931|NCT00721110|144778300|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9||||0.11|TWO_SIDED|97.5|-2.5|0.8||97.5% confidence intervals (CIs) adjusted for group sequential design (using confidence coefficient of 2.97) to maintain the overall α of 0.025 for each intervention and 0.05 for the trial.|t-test, 2 sided|||Lidocaine versus nonlidocaine on pain severity at postoperative care unit discharge was assessed using a t test.||0.8|-2.5|0.11
72623932|NCT00721110|144778300|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3||||0.56|TWO_SIDED|97.5|-1.4|2.0||97.5% confidence intervals (CIs) adjusted for group sequential design (using confidence coefficient of 2.97) to maintain the overall α of 0.025 for each intervention and 0.05 for the trial.|t-test, 2 sided|||Ketamine versus nonketamine on postoperative care unit discharge pain severity was assessed using a t test.||2.0|-1.4|0.56
72401069|NCT01265849|144309390|SUPERIORITY|||||||0.4051||||||For the primary efficacy measure a two-sided p-value of 0.05 or less is considered to be statistically significant in comparing the LI+CIZ+SOC treatment vs. SOC alone for superiority.|Log Rank|Log Rank statistic is based on an unstratified analysis.||The primary objective was to compare overall survival in the LI + CIZ + SOC group to that in the SOC alone group for superiority of the former.||||0.4051
72480449|NCT01668667|144487357|SUPERIORITY_OR_OTHER_LEGACY||Adjusted mean difference|-2.57|STANDARD_ERROR_OF_MEAN|0.745||0.014|TWO_SIDED|95.0|-4.62|-0.52|||ANCOVA|No adjustment for multiplicity will be made for these analyses.|The change from baseline data is analyzed using an ANCOVA model with treatment and pooled site as the main effects and the baseline IRLS Rating Scale total score as a covariate.|The null hypothesis for this study is that there is no difference between GEn and placebo in the change from Baseline to the end of treatment in the IRLS Rating Scale total score. All comparisons will be made at the two-sided 0.05 level of significance.||-0.52|-4.62|0.014
72480450|NCT01668667|144487357|SUPERIORITY_OR_OTHER_LEGACY||Adjusted mean difference|-2.61|STANDARD_ERROR_OF_MEAN|0.764||0.014|TWO_SIDED|95.0|-4.68|-0.54|||ANCOVA|No adjustment for multiplicity will be made for these analyses.|The change from baseline data is analyzed using an ANCOVA model with treatment and pooled site as the main effects and the baseline IRLS Rating Scale total score as a covariate.|The null hypothesis for this study is that there is no difference between GEn and placebo in the change from Baseline to the end of treatment in the IRLS Rating Scale total score. All comparisons will be made at the two-sided 0.05 level of significance.||-0.54|-4.68|0.014
72480451|NCT01668667|144487357|SUPERIORITY_OR_OTHER_LEGACY||Adjusted mean difference|-1.55|STANDARD_ERROR_OF_MEAN|0.767||0.144|TWO_SIDED|95.0|-3.63|0.53|||ANCOVA|No adjustment for multiplicity will be made for these analyses.|The change from baseline data is analyzed using an ANCOVA model with treatment and pooled site as the main effects and the baseline IRLS Rating Scale total score as a covariate|The null hypothesis for this study is that there is no difference between GEn and placebo in the change from Baseline to the end of treatment in the IRLS Rating Scale total score. All comparisons will be made at the two-sided 0.05 level of significance.||0.53|-3.63|0.144
72480452|NCT01668667|144487358|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.26||||0.004|TWO_SIDED|95.0|1.3|3.95|||Regression, Logistic||The analysis method used was logistic regression with terms of pooled site and treatment.|"The null hypothesis for this study is that there is no difference between GEn and placebo in the proportion of subjects who are responders with much improved or very much improved on the investigator-rated CGI-I at the end of treatment."||3.95|1.30|0.004
72480453|NCT01668667|144487358|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.15||||0.007|TWO_SIDED|95.0|1.23|3.77|||Regression, Logistic||The analysis method used was logistic regression with terms of pooled site and treatment.|"The null hypothesis for this study is that there is no difference between GEn and placebo in the proportion of subjects who are responders with much improved or very much improved on the investigator-rated CGI-I at the end of treatment."||3.77|1.23|0.007
72480454|NCT01668667|144487358|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.24||||0.005|TWO_SIDED|95.0|1.27|3.94|||Regression, Logistic||The analysis method used was logistic regression with terms of pooled site and treatment.|"The null hypothesis for this study is that there is no difference between GEn and placebo in the proportion of subjects who are responders with much improved or very much improved on the investigator-rated CGI-I at the end of treatment."||3.94|1.27|0.005
72480455|NCT01668667|144487359|SUPERIORITY_OR_OTHER_LEGACY|||||||0.022|TWO_SIDED||||||ANOVA|||For the mean change from Baseline for IRLS Rating Scale total score at the EOT, the linear contrast test based on an analysis of variance with treatment effect was used to detect linear dose-response trends across increasing levels of GEn dosage.||||0.022
72510025|NCT05372575|144550708|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|26.99|||||TWO_SIDED|95.0|11.46|63.58|||||GMR=(GMT of 13vPnC VT- or Sp- Subgroup)/(GMT of non-13vPnC VT- or Sp- Subgroup)|GMR of 13vPnC Cohort/non-13vPnC Cohort in VT- or Sp- Subgroups for Serotype: 19A||63.58|11.46|
72401070|NCT01265849|144309390|SUPERIORITY|||||||0.5402|||||||Log Rank|This Log Rank statistic is based on a stratified analysis.||||||0.5402
72480456|NCT01668667|144487359|SUPERIORITY_OR_OTHER_LEGACY|||||||0.072|TWO_SIDED||||||ANOVA|||Overall treatment effect||||0.072
72480457|NCT01668667|144487360|SUPERIORITY_OR_OTHER_LEGACY|||||||0.012|TWO_SIDED|||||A significant p-value will indicate a nonzero linear effect across increasing levels of GEn dosage.|Cochran-Armitage trend test|||||||0.012
72480458|NCT01992393|144487403|OTHER|||||||0.036|||||||GEE|||||||0.036
72480459|NCT01992393|144487404|OTHER|||||||0.042|||||||t-test, 2 sided|||A two-sided two sample t-test comparing difference of values from baseline and 12 week between TIME and TAU.||||0.042
72480460|NCT01992393|144487404|OTHER|||||||0.204|||||||t-test, 2 sided|||A two-sided two sample t-test comparing difference of values from baseline and 16 week between TIME and TAU||||0.204
72480461|NCT01992393|144487405|OTHER|||||||0.129|||||||t-test, 2 sided|||A two-sided two sample t-test comparing difference of values from baseline and 12 week between TIME and TAU.||||0.129
72480462|NCT01992393|144487405|OTHER|||||||0.978|||||||t-test, 2 sided|||A two-sided two sample t-test comparing difference of values from baseline and 16 week between TIME and TAU.||||0.978
72480463|NCT01992393|144487406|OTHER|||||||0.128|||||||t-test, 2 sided|||A two-sided two sample t-test comparing difference of values from baseline and 12 week between TIME and TAU.||||0.128
72480464|NCT01992393|144487406|OTHER|||||||0.015|||||||t-test, 2 sided|||A two-sided two sample t-test comparing difference of values from baseline and 16 week between TIME and TAU.||||0.015
72480465|NCT01992393|144487407|OTHER|||||||0.759|||||||t-test, 2 sided|||A two-sided two sample t-test comparing difference of values from baseline and 12 week between TIME and TAU.||||0.759
72401071|NCT01265849|144309390|SUPERIORITY||Hazard Ratio (HR)|1.09||||0.4128|TWO_SIDED|95.0|0.89|1.32|||Regression, Cox|The Cox Proportional Hazards Model included terms for treatment, tumor stage, tumor location, and geographic region.|A Hazard Ratio \< 1.0 would favor LI + CIZ + SOC.|||1.32|0.89|0.4128
72480466|NCT01992393|144487407|OTHER|||||||0.471|||||||t-test, 2 sided|||A two-sided two sample t-test comparing difference of values from baseline and 16 week between TIME and TAU.||||0.471
72480467|NCT01992393|144487408|OTHER|||||||0.775|||||||t-test, 2 sided|||A two-sided two sample t-test comparing difference of values from baseline and 12 week between TIME and TAU.||||0.775
72480468|NCT01992393|144487408|OTHER|||||||0.433|||||||t-test, 2 sided|||A two-sided two sample t-test comparing difference of values from baseline and 16 week between TIME and TAU.||||0.433
72480469|NCT01992393|144487409|OTHER|||||||0.936|||||||t-test, 2 sided|||A two-sided two sample t-test comparing difference of values from baseline and 12 week between TIME and TAU.||||0.936
72480470|NCT01992393|144487409|OTHER|||||||0.6|||||||t-test, 2 sided|||A two-sided two sample t-test comparing difference of values from baseline and 16 week between TIME and TAU.||||0.600
72510026|NCT05372575|144550708|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|15.53|||||TWO_SIDED|95.0|7.02|34.38|||||GMR=(GMT of 13vPnC VT- or Sp- Subgroup)/(GMT of non-13vPnC VT- or Sp- Subgroup)|GMR of 13vPnC Cohort/non-13vPnC Cohort in VT- or Sp- Subgroups for Serotype: 19F||34.38|7.02|
72510027|NCT05372575|144550708|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|48.73|||||TWO_SIDED|95.0|18.67|127.16|||||GMR=(GMT of 13vPnC VT- or Sp- Subgroup)/(GMT of non-13vPnC VT- or Sp- Subgroup)|GMR of 13vPnC Cohort/non-13vPnC Cohort in VT- or Sp- Subgroups for Serotype: 23F||127.16|18.67|
72480471|NCT01992393|144487410|OTHER|||||||0.56|||||||t-test, 2 sided|||A two-sided two sample t-test comparing difference of values from baseline and 12 week between TIME and TAU.||||0.560
72480472|NCT01992393|144487410|OTHER|||||||0.305|||||||t-test, 2 sided|||A two-sided two sample t-test comparing difference of values from baseline and 12 week between TIME and TAU.||||0.305
72480473|NCT01013597|144487415|SUPERIORITY_OR_OTHER_LEGACY|||||||0.98|||||||t-test, 2 sided|||||||0.98
72480474|NCT00427895|144487420|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|1.4|||||TWO_SIDED|95.0|1.1|1.78||||||Serotype 1: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS).||1.78|1.10|
72480475|NCT00427895|144487420|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|1.1|||||TWO_SIDED|95.0|0.9|1.32||||||Serotype 3: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS).||1.32|0.90|
72480476|NCT00427895|144487420|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|1.6|||||TWO_SIDED|95.0|1.19|2.13||||||Serotype 4: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS).||2.13|1.19|
72480477|NCT00427895|144487420|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|1.2|||||TWO_SIDED|95.0|0.93|1.62||||||Serotype 5: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS).||1.62|0.93|
72401072|NCT01265849|144309390|SUPERIORITY|||||||0.7181|||||||Log Rank|This Log Rank statistic is based on an unstratified analysis.||||||0.7181
72480478|NCT00427895|144487420|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|12.1|||||TWO_SIDED|95.0|8.63|17.08||||||Serotype 6A: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS).||17.08|8.63|
72480479|NCT00427895|144487420|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|2.5|||||TWO_SIDED|95.0|1.82|3.48||||||Serotype 6B: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS).||3.48|1.82|
72480480|NCT00427895|144487420|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|2.8|||||TWO_SIDED|95.0|1.98|3.87||||||Serotype 7F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS).||3.87|1.98|
72510028|NCT01544595|144550712|SUPERIORITY|"H1: Secukinumab 150 mg was not different from placebo with respect to the cumulative rate for patients who lost PASI 75 response up to Week 68~• H2: Secukinumab 300 mg was not different from placebo with respect to the cumulative rate for patients who lost PASI 75 response up to Week 68"|Hazard Ratio (HR)|0.3|||<|0.0001|TWO_SIDED|95.0|0.22|0.42|||Log Rank|||"The following hypotheses were tested for 52 weeks≤ t ≤68 weeks~* H1: p1(t) - p0,1(t) = 0 versus HA1: p1(t)- p0,1(t) ≥ 0,~* H2: p2(t) - p0,2(t) = 0 versus HA2: p2(t) - p0,2(t) ≥ 0,"||0.42|0.22|<0.0001
72576863|NCT00261443|144680664|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.29||||0.088|TWO_SIDED|95.0|-0.62|0.04||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 24 Comparison||0.04|-0.62|0.088
72401073|NCT01265849|144309390|SUPERIORITY|||||||0.948|||||||Log Rank|This log Rank p-value is based on a stratified analysis.||||||0.9480
72401074|NCT01265849|144309390|SUPERIORITY||Hazard Ratio (HR)|1.07||||0.6101|TWO_SIDED|95.0|0.81|1.42|||Regression, Cox|The Cox Proportional Hazards Model included terms for treatment, tumor stage, tumor location, and geographic region.|A hazard Ratio \< 1.0 would favor LI + SOC.|||1.42|0.81|0.6101
72401075|NCT01265849|144309391|SUPERIORITY|||||||0.0478|||||||Log Rank|This Log Rank statistic is based on an unstratified analysis.||||||0.0478
72401076|NCT01265849|144309391|SUPERIORITY|||||||0.0137|||||||Log Rank|This Log Rank statistic is based on a stratified analysis.||||||0.0137
72480481|NCT00427895|144487420|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|2.9|||||TWO_SIDED|95.0|2.0|4.08||||||Serotype 9V: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS).||4.08|2.00|
72480482|NCT00427895|144487420|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|0.9|||||TWO_SIDED|95.0|0.64|1.21||||||Serotype 14: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS).||1.21|0.64|
72480483|NCT00427895|144487420|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|1.9|||||TWO_SIDED|95.0|1.39|2.51||||||Serotype 18C: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS).||2.51|1.39|
72480484|NCT00427895|144487420|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|1.9|||||TWO_SIDED|95.0|1.56|2.41||||||Serotype 19A: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS).||2.41|1.56|
72576864|NCT00261443|144680664|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.34||||0.047|TWO_SIDED|95.0|-0.68|-0.01||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 28 Comparison||-0.01|-0.68|0.047
72401077|NCT01265849|144309391|SUPERIORITY||Hazard Ratio (HR)|0.68||||0.0236|TWO_SIDED|95.0|0.48|0.95|||Regression, Cox|The Cox Proportional Hazards Model included terms for treatment, tumor stage, tumor location, and geographic region.|A Hazard Ratio \< 1.0 would favor LI + CIZ + SOC.|||0.95|0.48|0.0236
72401078|NCT01265849|144309391|SUPERIORITY|||||||0.4115|||||||Log Rank|This Log Rank statistic is based on an unstratified analysis.||||||0.4115
72401079|NCT01265849|144309391|SUPERIORITY|||||||0.2862|||||||Log Rank|This Log Rank statistic is based on a stratified analysis.|||This HR is presented as (LI + SOC) / SOC. A HR \< 1.0 favors LI+SOC. Wald p-value for this HR is 0.3859.|||0.2862
72401080|NCT01265849|144309391|SUPERIORITY||Hazard Ratio (HR)|0.82||||0.3859|TWO_SIDED|95.0|0.52|1.29|||Regression, Cox|The Cox Proportional Hazards Model included terms for treatment, tumor stage, tumor location, and geographic region.|A Hazard Ratio \< 1.0 would favor LI + SOC.|||1.29|0.52|0.3859
72480485|NCT00427895|144487420|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|1.0|||||TWO_SIDED|95.0|0.72|1.28||||||Serotype 19F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS).||1.28|0.72|
72480486|NCT00427895|144487420|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|5.2|||||TWO_SIDED|95.0|3.67|7.33||||||Serotype 23F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS).||7.33|3.67|
72480487|NCT00427895|144487420|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|1.4|||||TWO_SIDED|95.0|1.08|1.73||||||Serotype 1: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures in 13vPnC participants between Cohort 1 and Cohort 2.||1.73|1.08|
72480488|NCT00427895|144487420|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|1.0|||||TWO_SIDED|95.0|0.81|1.19||||||Serotype 3: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures in 13vPnC participants between Cohort 1 and Cohort 2.||1.19|0.81|
72401081|NCT01265849|144309392|SUPERIORITY|||||||0.7304||||||P-values are not adjusted for multiple comparisons.|Log Rank|This Log Rank P-value is based on an unstratified analysis.||The secondary endpoint LRC failure is analyzed similar to the primary OS endpoint. The primary comparison is LI+CIZ+SOC vs SOC; LI+SOC vs SOC results are also reported.||||0.7304
72401082|NCT01265849|144309392|SUPERIORITY|||||||0.7171||||||P-values are reported unadjusted for multiplicity.|Log Rank|The Log Rank statistic is based on a stratified analysis.||||||0.7171
72401083|NCT01265849|144309392|SUPERIORITY||Hazard Ratio (HR)|1.04||||0.802|TWO_SIDED|95.0|0.79|1.36|||Regression, Cox|The Cox Proportional Hazards Model included terms for treatment, tumor stage, tumor location, and geographic region.|A Hazard Ratio \< 1.0 would favor LI + CIZ + SOC.|||1.36|0.79|0.8020
72401084|NCT01265849|144309392|SUPERIORITY|||||||0.4231|||||||Log Rank|The Log Rank statistic is based on an unstratified analysis.||||||0.4231
72401085|NCT01265849|144309392|SUPERIORITY|||||||0.6998|||||||Log Rank|This Log Rank statistic is based on a stratified analysis.||||||0.6998
72401086|NCT01265849|144309392|SUPERIORITY||Hazard Ratio (HR)|1.17||||0.3944|TWO_SIDED|95.0|0.81|1.69|||Regression, Cox|The Cox Proportional Hazards Model included terms for treatment, tumor stage, tumor location, and geographic region.|A Hazard Ratio \< 1.0 would favor LI + SOC.|||1.69|0.81|0.3944
72401087|NCT01265849|144309393|SUPERIORITY|||||||0.6142|||||||Log Rank|The Log Rank statistic is based on an unstratified analysis.||||||0.6142
72401088|NCT01265849|144309393|SUPERIORITY|||||||0.3024|||||||Log Rank|This Log Rank statistic is based on a stratified analysis.||||||0.3024
72401089|NCT01265849|144309393|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.42082|TWO_SIDED|95.0|0.55|1.28|||Regression, Cox||A Hazard Ratio \< 1.0 would favor LI + CIZ + SOC.|||1.28|0.55|0.42082
72401090|NCT01265849|144309393|SUPERIORITY|||||||0.9784|||||||Log Rank|The Log Rank statistic is based on an unstratified analysis.||||||0.9784
72401091|NCT01265849|144309393|SUPERIORITY|||||||0.8461||||||This Log Rank statistic is based on a stratified analysis.|Log Rank|||||||0.8461
72401092|NCT01265849|144309393|SUPERIORITY||Hazard Ratio (HR)|0.93||||0.8131|TWO_SIDED|95.0|0.53|1.65|||Regression, Cox||A Hazard Ratio of \< 1.0 would favor LI + SOC.|||1.65|0.53|0.8131
72401093|NCT01265849|144309394|SUPERIORITY|||||||0.3303|||||||Log Rank|This Log Rank statistic is from an unstratified analysis.||This secondary endpoint PFS is analyzed similar to OS and LRC.||||0.3303
72401094|NCT01265849|144309394|SUPERIORITY|||||||0.6669|||||||Log Rank|This Log Rank statistic is based on a stratified analysis.||||||0.6669
72401095|NCT01265849|144309394|SUPERIORITY||Hazard Ratio (HR)|1.09||||0.3728|TWO_SIDED|95.0|0.9|1.31|||Regression, Cox|The Cox Proportional Hazards Model included terms for treatment, tumor stage, tumor location, and geographic region.|A Hazard Ratio \< 1.0 would favor LI + CIZ + SOC.|||1.31|0.90|0.3728
72401096|NCT01265849|144309394|SUPERIORITY|||||||0.5739|||||||Log Rank|This Log Rank statistic is based on an unstratified analysis.||||||0.5739
72480489|NCT00427895|144487420|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|1.4|||||TWO_SIDED|95.0|1.07|1.77||||||Serotype 4: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures in 13vPnC participants between Cohort 1 and Cohort 2.||1.77|1.07|
72480490|NCT00427895|144487420|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|1.4||||||95.0|1.01|1.8||||||Serotype 5: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures in 13vPnC participants between Cohort 1 and Cohort 2.||1.80|1.01|
72401097|NCT01265849|144309394|SUPERIORITY|||||||0.8162|||||||Log Rank|This Log Rank statistic is based on a stratified analysis.||||||0.8162
72401098|NCT01265849|144309394|SUPERIORITY||Hazard Ratio (HR)|1.1||||0.4728|TWO_SIDED|95.0|0.84|1.43|||Regression, Cox|The Cox Proportional Hazards Model included terms for treatment, tumor stage, tumor location, and geographic region.|A Hazard Ratio \< 1.0 would favor LI + SOC.|||1.43|0.84|0.4728
72401099|NCT01265849|144309395|SUPERIORITY|||||||0.1797|||||||Log Rank|This Log Rank statistic is based on an unstratified analysis.||||||0.1797
72401100|NCT01265849|144309395|SUPERIORITY|||||||0.0159|||||||Log Rank|This Log Rank statistic is based on a stratified analysis.||||||0.0159
72401101|NCT01265849|144309395|SUPERIORITY||Hazard Ratio (HR)|0.76||||0.0896|TWO_SIDED|95.0|0.55|1.04|||Regression, Cox|The Cox Proportional Hazards Model included terms for treatment, tumor stage, tumor location, and geographic region.|A Hazard Ratio of \< 1.0 would favor LI + CIZ + SOC.|||1.04|0.55|0.0896
72480491|NCT00427895|144487420|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|1.7|||||TWO_SIDED|95.0|1.3|2.15||||||Serotype 6A: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures in 13vPnC participants between Cohort 1 and Cohort 2.||2.15|1.30|
72510029|NCT01544595|144550712|SUPERIORITY|"H1: Secukinumab 150 mg was not different from placebo with respect to the cumulative rate for patients who lost PASI 75 response up to Week 68~• H2: Secukinumab 300 mg was not different from placebo with respect to the cumulative rate for patients who lost PASI 75 response up to Week 68"|Hazard Ratio (HR)|0.2|||<|0.0001|TWO_SIDED|95.0|0.14|0.29|||Log Rank|||"The following hypotheses were tested for 52 weeks≤ t ≤68 weeks~* H1: p1(t) - p0,1(t) = 0 versus HA1: p1(t)- p0,1(t) ≥ 0,~* H2: p2(t) - p0,2(t) = 0 versus HA2: p2(t) - p0,2(t) ≥ 0,"||0.29|0.14|<0.0001
72401102|NCT01265849|144309395|SUPERIORITY|||||||0.5175|||||||Log Rank|This Log Rank statistic is based on an unstratified analysis.||||||0.5175
72401103|NCT01265849|144309395|SUPERIORITY|||||||0.453|||||||Log Rank|This Log Rank statistic is based on a stratified analysis.||||||0.4530
72401104|NCT01265849|144309395|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.4376|TWO_SIDED|95.0|0.54|1.3|||Regression, Cox|The Cox Proportional Hazards Model included terms for treatment, tumor stage, tumor location, and geographic region.|A Hazard Ratio \< 1.0 would favor LI + SOC.|||1.30|0.54|0.4376
72401105|NCT01265849|144309396|SUPERIORITY||Mean Difference (Net)|-3.0|STANDARD_ERROR_OF_MEAN|2.395||0.21|TWO_SIDED|||||This p-value for Long Term Follow-up at Month 2 is not adjusted for multiplicity.|Repeated Measures ANCOVA (RMANCOVA)|RMANCOVA with fixed stratification factors, trt, visit, trt\*visit, and baseline, with a compound symmetry correlation structure.|Positive value for the difference (Mean Difference (Net)) favors LI + CIZ + SOC.|Approximately 30% of participants completed the QOL instrument at first administration (Month2), thus the study did not have the power for QoL comparisons. These completer analyses are descriptive only.||||0.2100
72401106|NCT01265849|144309396|SUPERIORITY||Mean Difference (Net)|4.67|STANDARD_ERROR_OF_MEAN|3.401||0.1701|TWO_SIDED|||||This p-value for Long Term Follow-up at Month 2 is not adjusted for multiplicity.|Repeated Measures ANCOVA (RMANCOVA)|RMANCOVA with fixed stratification factors, trt, visit, trt\*visit, and baseline, with a compound symmetry correlation structure.|Positive value for the difference (Mean Difference (Net)) favors LI + SOC.|Approximately 30% of participants completed the QOL instrument at last administration (Month 36), thus the study did not have power for QoL comparisons. These completer analyses are descriptive only.||||0.1701
72401107|NCT01265849|144309397|SUPERIORITY|This p-value for Long Term Follow-up at Month 36 is not adjusted for multiplicity.|Median Difference (Net)|1.3|STANDARD_ERROR_OF_MEAN|2.397||0.5871|TWO_SIDED|||||This p-value for Long Term Follow-up at Month 36 is not adjusted for multiplicity.|Repeated Measures ANCOVA (RMANCOVA)|RMANCOVA with fixed stratification factors, trt, visit, trt\*visit, and baseline, with a compound symmetry correlation structure.|Positive value for the difference (Mean Difference (Net)) favors LI + CIZ + SOC.|LI + CIZ + SOC, Standard of Care (SOC)||||0.5871
72401108|NCT01265849|144309397|SUPERIORITY||Mean Difference (Net)|4.46|STANDARD_ERROR_OF_MEAN|3.247||0.17|TWO_SIDED|||||This p-value for Long Term Follow-up at Month 36 is not adjusted for multiplicity.|Repeated Measures ANCOVA (RMANCOVA)|RMANCOVA with fixed stratification factors, trt, visit, trt\*visit, and baseline, with a compound symmetry correlation structure.|Positive value for the difference (Mean Difference (Net)) favors LI + SOC.|||||0.1700
72480492|NCT00427895|144487420|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|1.6|||||TWO_SIDED|95.0|1.24|2.12||||||Serotype 6B: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures in 13vPnC participants between Cohort 1 and Cohort 2.||2.12|1.24|
72480493|NCT00427895|144487420|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|1.4|||||TWO_SIDED|95.0|1.03|1.79||||||Serotype 7F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures in 13vPnC participants between Cohort 1 and Cohort 2.||1.79|1.03|
72480494|NCT00427895|144487420|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|1.5||||||95.0|1.11|1.98||||||Serotype 9V: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures in 13vPnC participants between Cohort 1 and Cohort 2.||1.98|1.11|
72480495|NCT00427895|144487420|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|1.6|||||TWO_SIDED|95.0|1.16|2.12||||||Serotype 14: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures in 13vPnC participants between Cohort 1 and Cohort 2.||2.12|1.16|
72480496|NCT00427895|144487420|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|1.1|||||TWO_SIDED|95.0|0.86|1.47||||||Serotype 18C: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures in 13vPnC participants between Cohort 1 and Cohort 2.||1.47|0.86|
72480497|NCT00427895|144487420|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|1.4|||||TWO_SIDED|95.0|1.16|1.69||||||Serotype 19A: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures in 13vPnC participants between Cohort 1 and Cohort 2.||1.69|1.16|
72480498|NCT00427895|144487420|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|1.2|||||TWO_SIDED|95.0|0.87|1.54||||||Serotype 19F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures in 13vPnC participants between Cohort 1 and Cohort 2.||1.54|0.87|
72480499|NCT00427895|144487420|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|1.3|||||TWO_SIDED|95.0|0.94|1.84||||||Serotype 23F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures in 13vPnC participants between Cohort 1 and Cohort 2.||1.84|0.94|
72480500|NCT00427895|144487420|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|2.4|||||TWO_SIDED|95.0|2.03|2.87||||||Serotype 1: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures in 13vPnC participants between Cohort 1 and Cohort 3.||2.87|2.03|
72480501|NCT00427895|144487420|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|1.0|||||TWO_SIDED|95.0|0.84|1.13||||||Serotype 3: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures in 13vPnC participants between Cohort 1 and Cohort 3.||1.13|0.84|
72480502|NCT00427895|144487420|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|2.3|||||TWO_SIDED|95.0|1.92|2.76||||||Serotype 4: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures in 13vPnC participants between Cohort 1 and Cohort 3.||2.76|1.92|
72566698|NCT02149121|144664048|EQUIVALENCE|The equivalence of PK was to be concluded if the 90% CI for the ratio of geometric means in AUC0-last, AUC0-inf, and Cmax was entirely contained within the PK equivalence bounds of 80% and 125% for the following comparisons: CT-P10 versus Rituxan, CT-P10 versus MabThera, and Rituxan versus MabThera.|Ratio of geometric least squares means|94.18|||||TWO_SIDED|90.0|85.4|103.86|||||Point estimates (geometric least squares means and ratios of geometric means) were calculated by back-transforming the least squares means.|Primary PK analysis were analyzed using an ANCOVA model with treatment group as a fixed effect and gender, region, race, prior anti TNF alpha blocker status, and RF or anti-CCP status fitted as covariates.||103.86|85.40|
72566699|NCT02149121|144664048|EQUIVALENCE|The equivalence of PK was to be concluded if the 90% CI for the ratio of geometric means in AUC0-last, AUC0-inf, and Cmax was entirely contained within the PK equivalence bounds of 80% and 125% for the following comparisons: CT-P10 versus Rituxan, CT-P10 versus MabThera, and Rituxan versus MabThera.|Ratio of geometric least squares means|103.07|||||TWO_SIDED|90.0|93.32|113.85|||||Point estimates (geometric least squares means and ratios of geometric means) were calculated by back-transforming the least squares means.|Primary PK analysis were analyzed using an ANCOVA model with treatment group as a fixed effect and gender, region, race, prior anti TNF alpha blocker status, and RF or anti-CCP status fitted as covariates.||113.85|93.32|
72566700|NCT02149121|144664049|EQUIVALENCE|The equivalence of PK was to be concluded if the 90% CI for the ratio of geometric means in AUC0-last, AUC0-inf, and Cmax was entirely contained within the PK equivalence bounds of 80% and 125% for the following comparisons: CT-P10 versus Rituxan, CT-P10 versus MabThera, and Rituxan versus MabThera.|Ratio of geometric least squares means|95.81|||||TWO_SIDED|90.0|87.39|105.04|||||Point estimates (geometric least squares means and ratios of geometric means) were calculated by back-transforming the least squares means.|Primary PK analysis were analyzed using an ANCOVA model with treatment group as a fixed effect and gender, region, race, prior anti TNF alpha blocker status, and RF or anti-CCP status fitted as covariates.||105.04|87.39|
72566701|NCT02149121|144664049|EQUIVALENCE|The equivalence of PK was to be concluded if the 90% CI for the ratio of geometric means in AUC0-last, AUC0-inf, and Cmax was entirely contained within the PK equivalence bounds of 80% and 125% for the following comparisons: CT-P10 versus Rituxan, CT-P10 versus MabThera, and Rituxan versus MabThera.|Ratio of geometric least squares means|89.89|||||TWO_SIDED|90.0|81.85|98.72|||||Point estimates (geometric least squares means and ratios of geometric means) were calculated by back-transforming the least squares means.|Primary PK analysis were analyzed using an ANCOVA model with treatment group as a fixed effect and gender, region, race, prior anti TNF alpha blocker status, and RF or anti-CCP status fitted as covariates.||98.72|81.85|
72566702|NCT02149121|144664049|EQUIVALENCE|The equivalence of PK was to be concluded if the 90% CI for the ratio of geometric means in AUC0-last, AUC0-inf, and Cmax was entirely contained within the PK equivalence bounds of 80% and 125% for the following comparisons: CT-P10 versus Rituxan, CT-P10 versus MabThera, and Rituxan versus MabThera.|Ratio of geometric least squares means|106.58|||||TWO_SIDED|90.0|97.03|117.08|||||Point estimates (geometric least squares means and ratios of geometric means) were calculated by back-transforming the least squares means.|Primary PK analysis were analyzed using an ANCOVA model with treatment group as a fixed effect and gender, region, race, prior anti TNF alpha blocker status, and RF or anti-CCP status fitted as covariates.||117.08|97.03|
72566703|NCT02149121|144664050|EQUIVALENCE|The equivalence of PK was to be concluded if the 90% CI for the ratio of geometric means in AUC0-last, AUC0-inf, and Cmax was entirely contained within the PK equivalence bounds of 80% and 125% for the following comparisons: CT-P10 versus Rituxan, CT-P10 versus MabThera, and Rituxan versus MabThera.|Ratio of geometric least squares means|94.92|||||TWO_SIDED|90.0|89.61|100.55|||||Point estimates (geometric least squares means and ratios of geometric means) were calculated by back-transforming the least squares means.|Primary PK analysis were analyzed using an ANCOVA model with treatment group as a fixed effect and gender, region, race, prior anti TNF alpha blocker status, and RF or anti-CCP status fitted as covariates.||100.55|89.61|
72566704|NCT02149121|144664050|EQUIVALENCE|The equivalence of PK was to be concluded if the 90% CI for the ratio of geometric means in AUC0-last, AUC0-inf, and Cmax was entirely contained within the PK equivalence bounds of 80% and 125% for the following comparisons: CT-P10 versus Rituxan, CT-P10 versus MabThera, and Rituxan versus MabThera.|Ratio of geometric least squares means|89.0|||||TWO_SIDED|90.0|84.01|94.28|||||Point estimates (geometric least squares means and ratios of geometric means) were calculated by back-transforming the least squares means.|Primary PK analysis were analyzed using an ANCOVA model with treatment group as a fixed effect and gender, region, race, prior anti TNF alpha blocker status, and RF or anti-CCP status fitted as covariates.||94.28|84.01|
72566705|NCT02149121|144664050|EQUIVALENCE|The equivalence of PK was to be concluded if the 90% CI for the ratio of geometric means in AUC0-last, AUC0-inf, and Cmax was entirely contained within the PK equivalence bounds of 80% and 125% for the following comparisons: CT-P10 versus Rituxan, CT-P10 versus MabThera, and Rituxan versus MabThera.|Ratio of geometric least squares means|106.66|||||TWO_SIDED|90.0|100.56|113.13|||||Point estimates (geometric least squares means and ratios of geometric means) were calculated by back-transforming the least squares means.|Primary PK analysis were analyzed using an ANCOVA model with treatment group as a fixed effect and gender, region, race, prior anti TNF alpha blocker status, and RF or anti-CCP status fitted as covariates.||113.13|100.56|
72566706|NCT02149121|144664051|EQUIVALENCE|Therapeutic equivalence was to be concluded if the 90% CI for the treatment difference in the change from baseline of DAS28 (CRP) at Week 24 was entirely within the equivalence margin of ±0.50.|Mean Difference (Final Values)|-0.01|||||TWO_SIDED|90.0|-0.22|0.2|||||Adjusted least squares means and standard error, estimate of treatment difference \[CT-P10 - (Rituxan + MabThera)\] and 2-sided 90% confidence interval calculated from the ANCOVA model.|Primary efficacy analysis were analyzed using an ANCOVA model with treatment group as a fixed effect and gender, region, race, study part, interaction of treatment group with study part, prior anti TNF alpha blocker status at baseline (intolerance case versus inadequate response), and RF or anti-CCP status fitted as covariates.||0.20|-0.22|
72401109|NCT01265849|144309398|SUPERIORITY||Mean Difference (Net)|1.05|STANDARD_ERROR_OF_MEAN|2.183||0.6296|TWO_SIDED|||||This p-value for head and neck pain at Long Term Follow-up Month 2 is not adjusted for multiplicity.|Repeated Measures ANCOVA (RMANCOVA)|RMANCOVA with fixed effects of treatment, visit, treatment by visit, tumor location \& stage, geographic region, and baseline with compound symmetry.|Negative value for the difference (Mean Difference (Net)) favors LI + CIZ + SOC.|||||0.6296
72566707|NCT02149121|144664056|OTHER||Ratio of geometric least squares means|102.37|||||TWO_SIDED|95.0|92.46|113.33||||||Secondary PD analysis were analyzed using an ANCOVA model with results as the response, treatment group, as fixed effect and baseline values, gender, region, race, study part, interaction of treatment group with study part, prior anti-TNF alpha blocker status, and RF or anti-CCP status fitted as covariates.|Estimate of Geometric Least Square Mean and ratio of Geometric Least Square Means (CT-P10/reference products) were obtained from back transforming the least square means from the ANCOVA.|113.33|92.46|
72566708|NCT03166124|144664057|SUPERIORITY||Ratio of Geometric LSMeans|1.02|||||TWO_SIDED|95.0|0.953|1.1|||Mixed Models Analysis|||Geometric LSMeans were controlled for injection site, study period, and sequence as fixed effects, and subject within sequence as a random effect.||1.10|0.953|
72566709|NCT03166124|144664057|SUPERIORITY||Ratio of Geometric LSMeans|1.03|||||TWO_SIDED|95.0|0.974|1.09|||Mixed Models Analysis|||Geometric Least Squares Means (LSMeans) were controlled for injection site, study period, and sequence as fixed effects, and subject within sequence as a random effect.||1.09|0.974|
72566710|NCT03166124|144664058|SUPERIORITY||Ratio of Geometric LSMeans|1.04|||||TWO_SIDED|95.0|0.96|1.12|||Mixed Models Analysis|||Geometric LSMeans were controlled for injection site, study period, and sequence as fixed effects, and subject within sequence as a random effect.||1.12|0.96|
72566711|NCT03166124|144664058|SUPERIORITY||Ratio of Geometric LSMeans|1.02|||||TWO_SIDED|95.0|0.94|1.1|||Mixed Models Analysis|||Geometric LSMeans were controlled for injection site, study period, and sequence as fixed effects, and subject within sequence as a random effect.||1.10|0.94|
72401110|NCT01265849|144309398|SUPERIORITY||Mean Difference (Net)|1.01|STANDARD_ERROR_OF_MEAN|3.103||0.7454|TWO_SIDED|||||This p-value for head and neck pain at Long Term Follow-up Month 2 is not adjusted for multiplicity.|Repeated Measures ANCOVA (RMANCOVA)|RMANCOVA with fixed effects of treatment, visit, treatment by visit, tumor location \& stage, geographic region, and baseline with compound symmetry.|Negative value for the difference (Mean Difference (Net)) favors LI + SOC.|||||0.7454
72401111|NCT01265849|144309398|SUPERIORITY||Mean Difference (Net)|0.8|STANDARD_ERROR_OF_MEAN|2.465||0.7452|TWO_SIDED|||||This p-value for Long Term Follow-up for swallowing at month 2 is not adjusted for multiplicity.|Repeated Measures ANCOVA (RMANCOVA)|RMANCOVA with fixed effects of treatment, visit, treatment by visit, tumor location \& stage, geographic region, and baseline with compound symmetry.|Negative value for the difference (Mean Difference (Net)) favors LI + CIZ + SOC.|||||0.7452
72480503|NCT00427895|144487420|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|1.9|||||TWO_SIDED|95.0|1.55|2.42||||||Serotype 5: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures in 13vPnC participants between Cohort 1 and Cohort 3.||2.42|1.55|
72480504|NCT00427895|144487420|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|2.2|||||TWO_SIDED|95.0|1.84|2.67||||||Serotype 6A: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures in 13vPnC participants between Cohort 1 and Cohort 3.||2.67|1.84|
72480505|NCT00427895|144487420|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|4.9|||||TWO_SIDED|95.0|4.13|5.93||||||Serotype 6B: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures in 13vPnC participants between Cohort 1 and Cohort 3.||5.93|4.13|
72480506|NCT00427895|144487420|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|2.9|||||TWO_SIDED|95.0|2.41|3.49||||||Serotype 7F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures in 13vPnC participants between Cohort 1 and Cohort 3.||3.49|2.41|
72480507|NCT00427895|144487420|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|2.9|||||TWO_SIDED|95.0|2.34|3.52||||||Serotype 9V: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures in 13vPnC participants between Cohort 1 and Cohort 3.||3.52|2.34|
72510030|NCT04525222|144550734|OTHER||Slope|0.42||||0.0088|TWO_SIDED|95.0|0.1|0.74|||Regression, Linear|Adjusting for Treatment Arm, Sex Assigned at Birth, Baseline Level of Smoking (\<20 Cigs/ \>=20 Cigs), Baseline Depression Severity (PHQ-8\<5 / PHQ-8\>=5)||"Treatment satisfaction items are reported on a Likert-type scale, with response choices ranging from not at all to very much. We used a linear regression adjusting for Treatment Arm, Sex Assigned at Birth, Baseline Level of Smoking (\<20 Cigs/ \>=20 Cigs), and Baseline Depression Severity (PHQ-8\<5 / PHQ-8\>=5) to test for differences between arms."||0.74|0.10|0.0088
72480508|NCT00427895|144487420|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|4.9|||||TWO_SIDED|95.0|4.01|5.93||||||Serotype 14: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures in 13vPnC participants between Cohort 1 and Cohort 3.||5.93|4.01|
72510031|NCT04525222|144550735|OTHER||Slope|2.92||||0.75|TWO_SIDED|95.0|-15.22|21.07|||Negative Binomial Regression|Adjusting for Treatment Arm, Sex Assigned at Birth, Baseline Level of Smoking (\<20 Cigs/ \>=20 Cigs), Baseline Depression Severity (PHQ-8\<5 / PHQ-8\>=5)||||21.07|-15.22|0.75
72566712|NCT05626803|144664097|SUPERIORITY||||||<|0.0001|||||||ANCOVA|Computed by using ANCOVA model with log transformed data as response variable and treatment as a fixed factor and baseline value as covariate.||||||<.0001
72566713|NCT05626803|144664097|SUPERIORITY||||||<|0.0001|||||||ANCOVA|Computed by using ANCOVA model with log transformed data as response variable and treatment as a fixed factor and baseline value as covariate.||||||<.0001
72566714|NCT05626803|144664097|SUPERIORITY|||||||0.0003|||||||ANCOVA|Computed by using ANCOVA model with log transformed data as response variable and treatment as a fixed factor and baseline value as covariate.||||||0.0003
72566715|NCT05626803|144664099|SUPERIORITY||||||<|0.0001|||||||ANCOVA|Computed by using ANCOVA model with log transformed data as response variable and treatment as a fixed factor and baseline value as covariate.||||||<.0001
72566716|NCT05626803|144664099|SUPERIORITY||||||<|0.0001|||||||ANCOVA|Computed by using ANCOVA model with log transformed data as response variable and treatment as a fixed factor and baseline value as covariate.||||||<.0001
72401112|NCT01265849|144309398|SUPERIORITY||Mean Difference (Net)|-1.02|STANDARD_ERROR_OF_MEAN|3.496||0.771|TWO_SIDED|||||This p-value for Long Term Follow-up for swallowing at Month 2 is not adjusted for multiplicity.|Repeated Measures ANCOVA (RMANCOVA)|RMANCOVA with fixed effects of treatment, visit, treatment by visit, and baseline with compound symmetry.|Negative value for the difference (Mean Difference (Net)) favors LI + SOC.|||||0.7710
72401113|NCT01265849|144309399|SUPERIORITY||Mean Difference (Net)|-1.04|STANDARD_ERROR_OF_MEAN|2.185||0.6337|TWO_SIDED|||||This p-value for Long Term Follow-up for head and neck pain at Month 36 is not adjusted for multiplicity|Repeated Measures ANCOVA (RMANCOVA)|RMANCOVA with fixed stratification factors, trt, visit, trt\*visit, and baseline, with a compound symmetry correlation structure.|Negative value for the difference (Mean Difference (Net)) favors LI + CIZ + SOC.|||||0.6337
72401114|NCT01265849|144309399|SUPERIORITY||Mean Difference (Net)|-0.2|STANDARD_ERROR_OF_MEAN|2.962||0.945|TWO_SIDED|||||This p-value for Long Term Follow-up for head and neck pain at Month 36 is not adjusted for multiplicity.|Repeated Measures ANCOVA (RMANCOVA)|RMANCOVA with fixed stratification factors, trt, visit, trt\*visit, and baseline, with a compound symmetry correlation structure.|Negative value for the difference (Mean Difference (Net)) favors LI + SOC.|||||0.9450
72401115|NCT01265849|144309399|SUPERIORITY||Mean Difference (Net)|-2.04|STANDARD_ERROR_OF_MEAN|2.465||0.4071|TWO_SIDED|||||This p-value for Long Term Follow-up for Swallowing at Month 36 is not adjusted for multiplicity.|Repeated Measures ANCOVA (RMANCOVA)|RMANCOVA with fixed stratification factors, trt, visit, trt\*visit, and baseline, with a compound symmetry correlation structure.|Negative value for the difference (Mean Difference (Net)) favors LI+ CIZ + SOC.|||||0.4071
72401116|NCT01265849|144309399|SUPERIORITY||Mean Difference (Net)|-7.29|STANDARD_ERROR_OF_MEAN|3.347||0.0296|TWO_SIDED|||||This p-value for Long Term Follow-up for Swallowing at Month 36 is not adjusted for multiplicity.|Repeated Measures ANCOVA (RMANCOVA)|RMANCOVA with fixed stratification factors, trt, visit, trt\*visit, and baseline, with a compound symmetry correlation structure.|Negative value for the difference (Mean Difference (Net)) favors LI + SOC.|||||0.0296
72401117|NCT01265849|144309400|SUPERIORITY|Statistical tests were for a significant treatment effect in the Cox Proportional Hazards model including treatment, disease stage, tumor location, and geographical region.|% of significant test results|21.6|||<|0.05|TWO_SIDED|95.0|17.0|26.9||"Under the null hypothesis of no effect the expected number of significant test results would be balanced between treatments.~The expected number (%) of statistically significant results would be approximately 14 (5%) of 282."|Regression, Cox|||"Treatment comparisons of LI+CIZ+SOC v. SOC were repeated at all levels of HP, HP ratios, and HP combinations for endpoints OS, PFS, and LRC.~Significant outcomes for the treatment term in the model (two-sided p\<0.05) were accumulated."||26.9|17.0|<0.05
72401118|NCT01265849|144309401|SUPERIORITY||Percent (%) of Participants|8.1|||<|0.0001|TWO_SIDED|95.0|5.6|11.2|||Fisher Exact|||Null hypothesis is that percent (%) of participants with an objective response (CR+PR) is the same for LI + CIZ + SOC and SOC.||11.2|5.6|<.0001
72401119|NCT01265849|144309401|SUPERIORITY||Percent (%) of Participants|9.7|||<|0.0001|TWO_SIDED|95.0|4.7|14.7|||Fisher Exact|||Null hypothesis is that percent (%) of participants with an objective response (CR+PR) is the same for LI + SOC and SOC.||14.7|4.7|<0.0001
72401120|NCT01265849|144309402|SUPERIORITY||Percent (%) of Participants|15.2|||<|0.0001|TWO_SIDED|95.0|9.6|20.8|||Fisher Exact|||Null hypothesis is that percent (%) of participants with an objective response (CR+PR) is the same for LI + CIZ + SOC and SOC.||20.8|9.6|<0.0001
72401121|NCT01265849|144309402|SUPERIORITY||Percent (%) of Participants|18.5|||<|0.0001|TWO_SIDED|95.0|8.2|28.9|||Fisher Exact|||Null hypothesis is that percent (%) of participants with an objective response (CR+PR) is the same for LI + SOC and SOC.||28.9|8.2|<0.0001
72401122|NCT01265849|144309403|SUPERIORITY|||||||0.0007|||||||Fisher Exact|||The null hypothesis that survival is unrelated to objective response versus the alternative hypothesis that objective response is predictive of increased survival for participants receiving LI + CIZ + SOC.||||0.0007
72401123|NCT01265849|144309403|SUPERIORITY|||||||0.0434|||||||Fisher Exact|||The null hypothesis is that survival is unrelated to objective response versus the alternative that response is predictive of increased survival in subjects receiving LI + SOC.||||0.0434
72401124|NCT01265849|144309403|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||The null hypothesis is that survival is unrelated to objective response versus the alternative hypothesis that objective response is predictive of increased survival for participants receiving LI, considering both treatment groups combined.||||<0.0001
72401125|NCT01265849|144309404|SUPERIORITY|||||||0.0101|||||||Fisher Exact|||The null hypothesis that survival is unrelated to objective response versus the alternative hypothesis that objective response is predictive of increased survival for low risk participants receiving LI + CIZ + SOC.||||0.0101
72401126|NCT01265849|144309404|SUPERIORITY|||||||0.4843|||||||Fisher Exact|||The null hypothesis that survival is unrelated to objective response versus the alternative hypothesis that objective response is predictive of increased survival for low risk participants receiving LI + SOC.||||0.4843
72401127|NCT01265849|144309404|SUPERIORITY||||||<|0.0067||||||The null hypothesis is that survival is unrelated to objective response versus the alternative hypothesis that objective response is predictive of increased survival for participants receiving LI, considering both treatment groups combined.|Fisher Exact|||||||<0.0067
72401128|NCT01265849|144309405|SUPERIORITY||Hazard Ratio (HR)|0.348||||0.0131|TWO_SIDED|95.0|0.152|0.801|||Regression, Cox|||Null hypothesis is that the Hazard Ratio (HR) for low risk subjects responding to LI (combined arms LI + CIZ + SOC, LI + SOC) is \>=1.0 versus the alternative hypothesis that subjects responding to LI are at reduced risk of death (HR \< 1.0).||0.801|0.152|0.0131
72401129|NCT01265849|144309405|SUPERIORITY||Hazard Ratio (HR)|0.246||||0.0181|TWO_SIDED|95.0|0.077|0.787|||Regression, Cox|||Null hypothesis is that the Hazard Ratio (HR) for low risk subjects responding to LI + CIZ + SOC is \>=1.0 versus the alternative hypothesis that subjects responding to LI + CIZ + SOC are at reduced risk of death (HR \< 1.0).||0.787|0.077|0.0181
72401130|NCT02188589|144309412|EQUIVALENCE|The difference between the mean baseline and mean follow-up NOSE scores was evaluated by paired t-test with significance indicated by p\<0.05.|||||<|0.001|||||||t-test, 2 sided|||||||<0.001
72401131|NCT00003641|144309414|SUPERIORITY_OR_OTHER_LEGACY|||||||0.964|TWO_SIDED||||||Log Rank|stratified on the stratification factors used for randomization||||||0.964
72510032|NCT04525222|144550736|OTHER||Odds Ratio (OR)|1.33||||0.55|TWO_SIDED|95.0|0.5|3.48|||Regression, Logistic|Adjusting for Treatment Arm, Sex Assigned at Birth, Baseline Level of Smoking (\<20 Cigs/ \>=20 Cigs), Baseline Depression Severity (PHQ-8\<5 / PHQ-8\>=5)||||3.48|0.5|0.55
72401132|NCT00003641|144309415|SUPERIORITY_OR_OTHER_LEGACY|||||||0.558|TWO_SIDED||||||Log Rank|Stratified on the stratification factors used for randomization||||||0.558
72480509|NCT00427895|144487420|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|2.3|||||TWO_SIDED|95.0|1.91|2.79||||||Serotype 18C: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures in 13vPnC participants between Cohort 1 and Cohort 3.||2.79|1.91|
72480510|NCT00427895|144487420|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|2.3|||||TWO_SIDED|95.0|2.02|2.66||||||Serotype 19A: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures in 13vPnC participants between Cohort 1 and Cohort 3.||2.66|2.02|
72480511|NCT00427895|144487420|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|3.0|||||TWO_SIDED|95.0|2.44|3.6||||||Serotype 19F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures in 13vPnC participants between Cohort 1 and Cohort 3.||3.60|2.44|
72480512|NCT00427895|144487420|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|4.2|||||TWO_SIDED|95.0|3.31|5.31||||||Serotype 23F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures in 13vPnC participants between Cohort 1 and Cohort 3.||5.31|3.31|
72480513|NCT00427895|144487421|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|Difference in Percentage|39.2|||||TWO_SIDED|95.0|33.0|45.1||||||||45.1|33.0|
72480514|NCT00427895|144487422|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|3.4|||||TWO_SIDED|95.0|2.32|5.09||||||Serotype 1: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS).||5.09|2.32|
72480515|NCT00427895|144487422|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|1.6|||||TWO_SIDED|95.0|1.13|2.16||||||Serotype 3: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS).||2.16|1.13|
72480516|NCT00427895|144487422|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|1.3|||||TWO_SIDED|95.0|0.88|1.98||||||Serotype 4: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS).||1.98|0.88|
72480517|NCT00427895|144487422|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|3.2|||||TWO_SIDED|95.0|2.04|4.97||||||Serotype 5: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS).||4.97|2.04|
72480518|NCT00427895|144487422|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|2.5|||||TWO_SIDED|95.0|1.5|4.0||||||Serotype 6B: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS).||4.00|1.50|
72480519|NCT00427895|144487422|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|4.7|||||TWO_SIDED|95.0|2.76|7.99||||||Serotype 7F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS).||7.99|2.76|
72480520|NCT00427895|144487422|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|1.7|||||TWO_SIDED|95.0|0.93|2.97||||||Serotype 9V: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS).||2.97|0.93|
72480521|NCT00427895|144487422|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|1.5|||||TWO_SIDED|95.0|0.99|2.39||||||Serotype 14: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS).||2.39|0.99|
72401133|NCT00878709|144309442|SUPERIORITY||Hazard Ratio (HR)|0.66||||0.008|TWO_SIDED|95.0|0.49|0.9|||Log Rank|The Log-rank test is stratified by prior trastuzumab (concurrent or sequential), nodal status (\<= 3 or \>= 4) and ER/PgR status (positive or negative).|The hazard ratio is estimated by stratified Cox model. The Cox model is stratified by prior trastuzumab (concurrent or sequential), nodal status (\<= 3 or \>= 4) and ER/PgR status (positive or negative).|Invasive disease-free survival (iDFS) in neratinib arm compared to placebo arm.||0.90|0.49|0.008
72510033|NCT04525222|144550737|OTHER||Odds Ratio (OR)|1.63||||0.17|TWO_SIDED|95.0|0.8|3.32|||Regression, Logistic|Adjusting for Treatment Arm, Sex Assigned at Birth, Baseline Level of Smoking \<20 Cigs/ \>=20 Cigs, Baseline Depression Severity PHQ-8\<5 / PHQ-8\>=5||||3.32|0.80|0.17
72510034|NCT04525222|144550738|OTHER||Odds Ratio (OR)|1.63||||0.25|TWO_SIDED|95.0|0.7|3.81|||Regression, Logistic|Adjusting for Treatment Arm, Sex Assigned at Birth, Baseline Level of Smoking (\<20 Cigs/ \>=20 Cigs), Baseline Depression Severity (PHQ-8\<5 / PHQ-8\>=5)||||3.81|0.70|0.25
72401134|NCT00878709|144309444|SUPERIORITY||Hazard Ratio (HR)|0.952||||0.6914|TWO_SIDED|95.0|0.747|1.212|||Log Rank|||The 2-sided P-value was based on stratified log-rank test (stratification factors: prior Trastuzumab (concurrent or sequential), nodal status (\<=3 or \>=4) and ER/PgR status (positive or negative). The hazard ratio and corresponding 95% CI from the stratified cox proportional hazard model were also presented.||1.212|0.747|0.6914
72480522|NCT00427895|144487422|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|2.2|||||TWO_SIDED|95.0|1.37|3.5||||||Serotype 18C: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS).||3.50|1.37|
72480523|NCT00427895|144487422|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|2.6|||||TWO_SIDED|95.0|1.78|3.68||||||Serotype 19A: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS).||3.68|1.78|
72480524|NCT00427895|144487422|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|2.7|||||TWO_SIDED|95.0|1.77|4.01||||||Serotype 19F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS).||4.01|1.77|
72480525|NCT00427895|144487422|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|3.5|||||TWO_SIDED|95.0|1.99|6.13||||||Serotype 23F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS).||6.13|1.99|
72480526|NCT00427895|144487422|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|4.2|||||TWO_SIDED|95.0|2.87|6.08||||||Serotype 1: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS/23vPS).||6.08|2.87|
72480527|NCT00427895|144487422|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|3.1|||||TWO_SIDED|95.0|2.26|4.3||||||Serotype 3: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS/23vPS).||4.30|2.26|
72480528|NCT00427895|144487422|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT ratio|2.6|||||TWO_SIDED|95.0|1.72|3.8||||||Serotype 4: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS/23vPS).||3.80|1.72|
72510035|NCT04525222|144550739|OTHER||Odds Ratio (OR)|1.88||||0.07|TWO_SIDED|95.0|0.94|3.72||Adjusting for Treatment Arm, Sex Assigned at Birth, Baseline Level of Smoking (\<20 Cigs/ \>=20 Cigs), Baseline Depression Severity (PHQ-8\<5 / PHQ-8\>=5)|Regression, Logistic|Adjusting for Treatment Arm, Sex Assigned at Birth, Baseline Level of Smoking (\<20 Cigs/ \>=20 Cigs), Baseline Depression Severity (PHQ-8\<5 / PHQ-8\>=5)||||3.72|0.94|0.07
72480529|NCT00427895|144487422|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|6.5|||||TWO_SIDED|95.0|4.09|10.19||||||Serotype 5: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS/23vPS).||10.19|4.09|
72480530|NCT00427895|144487422|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|2.9|||||TWO_SIDED|95.0|1.83|4.63||||||Serotype 6B: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS/23vPS).||4.63|1.83|
72480531|NCT00427895|144487422|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|3.8|||||TWO_SIDED|95.0|2.41|6.03||||||Serotype 7F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS/23vPS).||6.03|2.41|
72480532|NCT00427895|144487422|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|5.8|||||TWO_SIDED|95.0|3.13|10.82||||||Serotype 9V: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS/23vPS).||10.82|3.13|
72480533|NCT00427895|144487422|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|1.9|||||TWO_SIDED|95.0|1.3|2.84||||||Serotype 14: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS/23vPS).||2.84|1.30|
72480534|NCT00427895|144487422|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|3.1|||||TWO_SIDED|95.0|2.02|4.78||||||Serotype 18C: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS/23vPS).||4.78|2.02|
72510036|NCT04525222|144550740|OTHER||Odds Ratio (OR)|2.42||||0.04|TWO_SIDED|95.0|1.0|5.85|||Regression, Logistic|Adjusting for Treatment Arm, Sex Assigned at Birth, Baseline Level of Smoking (\<20 Cigs/ \>=20 Cigs), Baseline Depression Severity (PHQ-8\<5 / PHQ-8\>=5)||||5.85|1.00|0.04
72510037|NCT04525222|144550741|OTHER||Odds Ratio (OR)|1.47||||0.25|TWO_SIDED|95.0|0.75|2.89|||Regression, Logistic|Adjusting for Treatment Arm, Sex Assigned at Birth, Baseline Level of Smoking (\<20 Cigs/ \>=20 Cigs), Baseline Depression Severity (PHQ-8\<5 / PHQ-8\>=5)||||2.89|0.75|0.25
72401135|NCT00878709|144309445|OTHER||Hazard Ratio (HR)|0.61|||||TWO_SIDED|95.0|0.45|0.83|||||The hazard ratio is estimated by stratified Cox model. The Cox model is stratified by prior trastuzumab (concurrent or sequential), nodal status (\<= 3 or \>= 4) and ER/PgR status (positive or negative).|Disease-free survival including ductal carcinoma in situ (DFS-DCIS) in neratinib arm compared to placebo arm.||0.83|0.45|
72480535|NCT00427895|144487422|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|2.7|||||TWO_SIDED|95.0|1.87|3.76||||||Serotype 19A: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS/23vPS).||3.76|1.87|
72510038|NCT04525222|144550742|OTHER||Odds Ratio (OR)|1.78||||0.17|TWO_SIDED|95.0|0.77|4.12|||Regression, Logistic|Adjusting for Treatment Arm, Sex Assigned at Birth, Baseline Level of Smoking (\<20 Cigs/ \>=20 Cigs), Baseline Depression Severity (PHQ-8\<5 / PHQ-8\>=5)||||4.12|0.77|0.17
72480536|NCT00427895|144487422|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|4.4|||||TWO_SIDED|95.0|2.97|6.58||||||Serotype 19F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS/23vPS).||6.58|2.97|
72480537|NCT00427895|144487422|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|5.5|||||TWO_SIDED|95.0|3.2|9.41||||||Serotype 23F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS/23vPS).||9.41|3.20|
72480538|NCT00427895|144487423|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.|Difference in Percentage|6.5|||||TWO_SIDED|95.0|1.9|11.2||||||Serotype 1: Difference (13vPnC - 23vPS) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.||11.2|1.9|
72480539|NCT00427895|144487423|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.|Difference in Percentage|3.9|||||TWO_SIDED|95.0|-0.3|8.1||||||Serotype 3: Difference (13vPnC - 23vPS) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.||8.1|-0.3|
72480540|NCT00427895|144487423|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.|Difference in Percentage|3.4|||||TWO_SIDED|95.0|-0.2|7.2||||||Serotype 4: Difference (13vPnC - 23vPS) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.||7.2|-0.2|
72480541|NCT00427895|144487423|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.|Difference in Percentage|2.3|||||TWO_SIDED|95.0|-2.6|7.2||||||Serotype 5: Difference (13vPnC - 23vPS) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.||7.2|-2.6|
72510039|NCT04525222|144550743|OTHER||Odds Ratio (OR)|1.91||||0.15|TWO_SIDED|95.0|0.77|4.73|||Regression, Logistic|Adjusting for Treatment Arm, Sex Assigned at Birth, Baseline Level of Smoking (\<20 Cigs/ \>=20 Cigs), Baseline Depression Severity (PHQ-8\<5 / PHQ-8\>=5)||||4.73|0.77|0.15
72480542|NCT00427895|144487423|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.|Difference in Percentage|26.6|||||TWO_SIDED|95.0|21.7|31.7||||||Serotype 6A: Difference (13vPnC - 23vPS) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.||31.7|21.7|
72480543|NCT00427895|144487423|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.|Difference in Percentage|7.5|||||TWO_SIDED|95.0|3.2|12.0||||||Serotype 6B: Difference (13vPnC - 23vPS) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.||12.0|3.2|
72480544|NCT00427895|144487423|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.|Difference in Percentage|12.3|||||TWO_SIDED|95.0|7.3|17.4||||||Serotype 7F: Difference (13vPnC - 23vPS) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.||17.4|7.3|
72510040|NCT04525222|144550744|OTHER||Odds Ratio (OR)|1.25||||0.68|TWO_SIDED|95.0|0.41|3.86|||Regression, Logistic|Adjusting for Treatment Arm, Sex Assigned at Birth, Baseline Level of Smoking (\<20 Cigs/ \>=20 Cigs), Baseline Depression Severity (PHQ-8\<5 / PHQ-8\>=5)||||3.86|0.41|0.68
72401136|NCT00878709|144309447|OTHER||Hazard Ratio (HR)|0.74|||||TWO_SIDED|95.0|0.52|1.05|||||The hazard ratio is estimated by stratified Cox model. The Cox model is stratified by prior trastuzumab (concurrent or sequential), nodal status (\<= 3 or \>= 4) and ER/PgR status (positive or negative).|Distant disease free survival (DDFS) in neratinib arm compared to placebo arm.||1.05|0.52|
72480545|NCT00427895|144487423|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.|Difference in Percentage|14.1|||||TWO_SIDED|95.0|8.7|19.5||||||Serotype 9V: Difference (13vPnC - 23vPS) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.||19.5|8.7|
72510041|NCT04525222|144550745|OTHER||Odds Ratio (OR)|1.63||||0.21|TWO_SIDED|95.0|0.75|3.46|||Regression, Logistic|Adjusting for Treatment Arm, Sex Assigned at Birth, Baseline Level of Smoking (\<20 Cigs/ \>=20 Cigs), Baseline Depression Severity (PHQ-8\<5 / PHQ-8\>=5)||||3.46|0.75|0.21
72510042|NCT04525222|144550746|OTHER||Odds Ratio (OR)|1.63||||0.3|TWO_SIDED|95.0|0.63|4.19|||Regression, Logistic|Adjusting for Treatment Arm, Sex Assigned at Birth, Baseline Level of Smoking (\<20 Cigs/ \>=20 Cigs), Baseline Depression Severity (PHQ-8\<5 / PHQ-8\>=5)||||4.19|0.63|0.30
72510043|NCT04525222|144550747|OTHER||Slope|-1.68||||0.0072|TWO_SIDED|95.0|-2.9|-0.46|||Regression, Linear|Adjusting for Treatment Arm, Sex Assigned at Birth, Baseline Level of Smoking (\<20 Cigs/ \>=20 Cigs), Baseline Depression Severity (PHQ-8\<5 / PHQ-8\>=5)||||-0.46|-2.90|.0072
72510044|NCT04525222|144550748|OTHER||Odds Ratio (OR)|1.829||||0.177|TWO_SIDED|95.0|0.77|4.344|||Regression, Logistic|Adjusting for Treatment Arm, Sex Assigned at Birth, Baseline Level of Smoking (\<20 Cigs/ \>=20 Cigs), Baseline Depression Severity (PHQ-8\<5 / PHQ-8\>=5)||||4.344|0.770|0.1770
72510045|NCT04525222|144550749|OTHER||Slope|3.62||||0.0025|TWO_SIDED|95.0|1.28|5.95|||Regression, Linear|Adjusting for Treatment Arm, Sex Assigned at Birth, Baseline Level of Smoking (\<20 Cigs/ \>=20 Cigs), Baseline Depression, Baseline Activation Score||||5.95|1.28|0.0025
72401137|NCT00878709|144309449|OTHER||Hazard Ratio (HR)|0.73|||||TWO_SIDED|95.0|0.51|1.04|||||The hazard ratio is estimated by stratified Cox model. The Cox model is stratified by prior trastuzumab (concurrent or sequential), nodal status (\<= 3 or \>= 4) and ER/PgR status (positive or negative).|Time to distant recurrence (TTDR) in neratinib arm compared to placebo arm.||1.04|0.51|
72401138|NCT00878709|144309453|OTHER||Hazard Ratio (HR)|0.73||||0.008|TWO_SIDED|95.0|0.57|0.92||The Log-rank test is stratified by prior trastuzumab (concurrent or sequential), nodal status (\<= 3 or \>= 4) and ER/PgR status (positive or negative).|Log Rank||The hazard ratio is estimated by stratified Cox model. The Cox model is stratified by prior trastuzumab (concurrent or sequential), nodal status (\<= 3 or \>= 4) and ER/PgR status (positive or negative).|Invasive disease-free survival (iDFS) in neratinib arm compared to placebo arm.||0.92|0.57|0.008
72480546|NCT00427895|144487423|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.|Difference in Percentage|-0.9|||||TWO_SIDED|95.0|-5.6|3.8||||||Serotype 14: Difference (13vPnC - 23vPS) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.||3.8|-5.6|
72401139|NCT00878709|144309455|OTHER||Hazard Ratio (HR)|0.71|||||TWO_SIDED|95.0|0.56|0.89|||||The hazard ratio is estimated by stratified Cox model. The Cox model is stratified by prior trastuzumab (concurrent or sequential), nodal status (\<= 3 or \>= 4) and ER/PgR status (positive or negative).|||0.89|0.56|
72480547|NCT00427895|144487423|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.|Difference in Percentage|6.5|||||TWO_SIDED|95.0|2.6|10.5||||||Serotype 18C: Difference (13vPnC - 23vPS) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.||10.5|2.6|
72480548|NCT00427895|144487423|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.|Difference in Percentage|4.1|||||TWO_SIDED|95.0|1.2|7.1||||||Serotype 19A: Difference (13vPnC - 23vPS) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.||7.1|1.2|
72480549|NCT00427895|144487423|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|Difference in Percentage|-1.2|||||TWO_SIDED|95.0|-5.5|3.2||||||Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.||3.2|-5.5|
72480550|NCT00427895|144487423|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.|Difference in Percentage|23.2|||||TWO_SIDED|95.0|17.0|29.3||||||Serotype 23F: Difference (13vPnC - 23vPS) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.||29.3|17.0|
72566717|NCT05626803|144664099|SUPERIORITY||||||<|0.0001|||||||ANCOVA|Computed by using ANCOVA model with log transformed data as response variable and treatment as a fixed factor and baseline value as covariate.||||||<.0001
72401140|NCT00878709|144309456|OTHER||Hazard Ratio (HR)|0.78|||||TWO_SIDED|95.0|0.6|1.01|||||The hazard ratio is estimated by stratified Cox model. The Cox model is stratified by prior trastuzumab (concurrent or sequential), nodal status (\<= 3 or \>= 4) and ER/PgR status (positive or negative).|||1.01|0.6|
72480551|NCT00427895|144487423|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.|Difference in Percentage|3.6|||||TWO_SIDED|95.0|-0.2|7.5||||||Serotype 1: Difference (cohort 2 - cohort 1) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.||7.5|-0.2|
72480552|NCT00427895|144487423|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.|Difference in Percentage|0.2|||||TWO_SIDED|95.0|-3.6|4.1||||||Serotype 3: Difference (cohort 2 - cohort 1) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.||4.1|-3.6|
72480553|NCT00427895|144487423|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.|Difference in Percentage|2.4|||||TWO_SIDED|95.0|-0.4|5.5||||||Serotype 4: Difference (cohort 2 - cohort 1) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.||5.5|-0.4|
72480554|NCT00427895|144487423|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.|Difference in Percentage|-0.9|||||TWO_SIDED|95.0|-5.8|3.9||||||Serotype 5: Difference (cohort 2 - cohort 1) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.||3.9|-5.8|
72401141|NCT00878709|144309457|OTHER||Hazard Ratio (HR)|0.79|||||TWO_SIDED|95.0|0.6|1.03|||||The hazard ratio is estimated by stratified Cox model. The Cox model is stratified by prior trastuzumab (concurrent or sequential), nodal status (\<= 3 or \>= 4) and ER/PgR status (positive or negative).|||1.03|0.60|
72401142|NCT03886220|144309465|SUPERIORITY||Odds Ratio (OR)|3.22||||0.035|TWO_SIDED|95.0|1.086|9.546||P-value for test of difference between elagolix dose group and placebo is by pooling the results from a logistic regression model including treatment as the main effect and baseline MBL volume as a covariate in each dataset from multiple imputation.|Regression, Logistic|||||9.546|1.086|0.035
72480555|NCT00427895|144487423|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.|Difference in Percentage|2.2|||||TWO_SIDED|95.0|-0.4|4.8||||||Serotype 6A: Difference (cohort 2 - cohort 1) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.||4.8|-0.4|
72480556|NCT00427895|144487423|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.|Difference in Percentage|4.0|||||TWO_SIDED|95.0|0.8|7.2||||||Serotype 6B: Difference (cohort 2 - cohort 1) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.||7.2|0.8|
72566718|NCT05626803|144664101|SUPERIORITY||||||<|0.0001|||||||ANCOVA|Computed by using ANCOVA model with log transformed data as response variable and treatment as a fixed factor and baseline value as covariate.||||||<.0001
72480557|NCT00427895|144487423|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.|Difference in Percentage|4.4|||||TWO_SIDED|95.0|0.6|8.2||||||Serotype 7F: Difference (cohort 2 - cohort 1) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.||8.2|0.6|
72480558|NCT00427895|144487423|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.|Difference in Percentage|3.8|||||TWO_SIDED|95.0|-0.3|7.9||||||Serotype 9V: Difference (cohort 2 - cohort 1) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.||7.9|-0.3|
72480559|NCT00427895|144487423|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.|Difference in Perecentage|4.2|||||TWO_SIDED|95.0|-0.1|8.7||||||Serotype 14: Difference (cohort 2 - cohort 1) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.||8.7|-0.1|
72510046|NCT00320385|144550755|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.73||||0.008|TWO_SIDED|95.0|0.57|0.93|||Log Rank||The Pike estimator of the treatment hazard ratio based on the log-rank test was provided, together with a 95% confidence interval.|||0.93|0.57|0.008
72401143|NCT00768300|144309466|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.74||||0.01|TWO_SIDED|95.0|1.14|2.66||P-value was based on a stratified log-rank test with strata of baseline presence of pulmonary hypertension and whether a surgical lung biopsy was performed with definite or probable usual interstitial pneumonia (UIP) based on core pathology review.|Log Rank||The hazard ratio was based on a stratified Cox proportional hazards model with strata of baseline presence of pulmonary hypertension and whether a surgical lung biopsy was performed with definite or probable UIP based on core pathology review.|||2.66|1.14|0.010
72480560|NCT00427895|144487423|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.|Difference in Percentage|-0.6|||||TWO_SIDED|95.0|-3.8|2.5||||||Serotype 18C: Difference (cohort 2 - cohort 1) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.||2.5|-3.8|
72480561|NCT00427895|144487423|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.|Difference in Percentage|-0.1|||||TWO_SIDED|95.0|-2.1|1.9||||||Serotype 19A: Difference (cohort 2 - cohort 1) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.||1.9|-2.1|
72480562|NCT00427895|144487423|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.|Difference in Percentage|1.9|||||TWO_SIDED|95.0|-2.4|6.2||||||Serotype 19F: Difference (cohort 2 - cohort 1) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.||6.2|-2.4|
72480563|NCT00427895|144487423|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.|Difference in Percentage|0.5|||||TWO_SIDED|95.0|-4.7|5.7||||||Serotype 23F: Difference (cohort 2 - cohort 1) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.||5.7|-4.7|
72510047|NCT00320385|144550756|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.75||||0.106|TWO_SIDED|95.0|0.53|1.07|||Log Rank||The Pike estimator of the treatment hazard ratio based on the log-rank test was provided, together with a 95% confidence interval.|||1.07|0.53|0.106
72480564|NCT00427895|144487423|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.|Difference in Percentage|7.2|||||TWO_SIDED|95.0|4.3|10.6||||||Serotype 1: Difference (cohort 3 - cohort 1) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.||10.6|4.3|
72480565|NCT00427895|144487423|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.|Difference in Percentage|2.6|||||TWO_SIDED|95.0|-0.3|5.9||||||Serotype 3: Difference (cohort 3 - cohort 1) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.||5.9|-0.3|
72480566|NCT00427895|144487423|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.|Difference in Percentage|4.2|||||TWO_SIDED|95.0|2.1|6.9||||||Serotype 4: Difference (cohort 3 - cohort 1) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.||6.9|2.1|
72480567|NCT00427895|144487423|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.|Difference in Percentage|5.1|||||TWO_SIDED|95.0|1.4|9.1||||||Serotype 5: Difference (cohort 3 - cohort 1) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.||9.1|1.4|
72480568|NCT00427895|144487423|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.|Difference in Percentage|3.7|||||TWO_SIDED|95.0|1.7|6.1||||||Serotype 6A: Difference (cohort 3 - cohort 1) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.||6.1|1.7|
72480569|NCT00427895|144487423|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.|Difference in Percentage|6.4|||||TWO_SIDED|95.0|4.1|9.3||||||Serotype 6B: Difference (cohort 3 - cohort 1) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.||9.3|4.1|
72480570|NCT00427895|144487423|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.|Difference in Percentage|8.2|||||TWO_SIDED|95.0|5.4|11.6||||||Serotype 7F: Difference (cohort 3 - cohort 1) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.||11.6|5.4|
72510048|NCT00320385|144550757|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.5||||0.46|TWO_SIDED|95.0|0.6|3.9|||Fisher Exact||Responses were compared between treatment arms using stratified Fisher's exact tests.|||3.9|0.6|0.460
72510049|NCT00320385|144550758|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.2||||0.01|TWO_SIDED|95.0|1.2|4.5|||Fisher Exact||Clinical Benefit was compared between treatment arms using stratified Fisher's exact tests.|||4.5|1.2|0.010
72510050|NCT01355068|144550772|SUPERIORITY_OR_OTHER_LEGACY||Ratio of Adjusted Means|101.33|||||TWO_SIDED|90.0|97.85|104.94||||||Natural log transformed AUClast was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% confidence intervals (CIs) for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||104.94|97.85|
72480571|NCT00427895|144487423|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.|Difference in Percentage|7.8|||||TWO_SIDED|95.0|4.8|11.4||||||Serotype 9V: Difference (cohort 3 - cohort 1) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.||11.4|4.8|
72480572|NCT00427895|144487423|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.|Difference in Percentage|11.2|||||TWO_SIDED|95.0|8.0|14.9||||||Serotype 14: Difference (cohort 3 - cohort 1) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.||14.9|8.0|
72480573|NCT00427895|144487423|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.|Difference in Percentage|3.1|||||TWO_SIDED|95.0|0.9|5.7||||||Serotype 18C: Difference (cohort 3 - cohort 1) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.||5.7|0.9|
72480574|NCT00427895|144487423|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.|Difference in Percentage|1.4|||||TWO_SIDED|95.0|0.3|3.1||||||Serotype 19A: Difference (cohort 3 - cohort 1) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.||3.1|0.3|
72510051|NCT01355068|144550773|SUPERIORITY_OR_OTHER_LEGACY||Ratio of Adjusted Means|102.2|||||TWO_SIDED|90.0|97.18|107.47||||||Natural log transformed Cmax was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||107.47|97.18|
72510052|NCT01355068|144550774|SUPERIORITY_OR_OTHER_LEGACY||Ratio of Adjusted Means|101.43|||||TWO_SIDED|90.0|97.56|105.47||||||Natural log transformed AUC (0-∞) was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||105.47|97.56|
72480575|NCT00427895|144487423|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.|Difference in Percentage|8.4|||||TWO_SIDED|95.0|5.4|12.0||||||Serotype 19F: Difference (cohort 3 - cohort 1) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.||12.0|5.4|
72480576|NCT00427895|144487423|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.|Difference in Percentage|10.5|||||TWO_SIDED|95.0|6.8|14.7||||||Serotype 23F: Difference (cohort 3 - cohort 1) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.||14.7|6.8|
72480577|NCT00427895|144487425|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMC Ratio|2.31|||||TWO_SIDED|95.0|1.52|3.51||||||Serotype 1: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS).||3.51|1.52|
72480578|NCT00427895|144487425|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMC Ratio|1.37|||||TWO_SIDED|95.0|0.95|1.99||||||Serotype 3: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS).||1.99|0.95|
72480579|NCT00427895|144487425|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMC Ratio|2.32|||||TWO_SIDED|95.0|1.47|3.64||||||Serotype 4: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS).||3.64|1.47|
72510053|NCT00872170|144550782|SUPERIORITY_OR_OTHER|||||||0.97||95.0|||||Mixed Models Analysis|Linear mixed models with participant-specific intercepts and slopes controlled for time effects were used.||This study had 80% power at level alpha=0.05 to detect a 60 m change in 6MWT among N=10 participants, assuming a 60 m standard deviation for 12-week change.||||0.97
72480580|NCT00427895|144487425|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMC Ratio|1.4|||||TWO_SIDED|95.0|0.92|2.12||||||Serotype 5: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS).||2.12|0.92|
72480581|NCT00427895|144487425|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMC Ratio|1.47|||||TWO_SIDED|95.0|1.01|2.16||||||Serotype 6B: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS).||2.16|1.01|
72480582|NCT00427895|144487425|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMC Ratio|1.03|||||TWO_SIDED|95.0|0.67|1.59||||||Serotype 7F: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS).||1.59|0.67|
72510054|NCT00872170|144550783|SUPERIORITY_OR_OTHER|||||||0.04||95.0|||||Mixed Models Analysis|Linear mixed models with participant-specific intercepts and slopes controlled for time effects were used.||||||0.04
72401144|NCT00768300|144309468|SUPERIORITY_OR_OTHER||Point estimate|4.29||||0.086|TWO_SIDED|95.0|-0.805|9.376||P-value was calculated using the Van Elteren test with strata of baseline presence of PH and whether a SLB was performed with definite or probable UIP based on core pathology review.|Van Elteren test||The point estimate and 95% confidence interval (CI) were based on the Hodges-Lehmann Estimate of treatment effect for percent change from baseline.|||9.376|-0.805|0.086
72480583|NCT00427895|144487425|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMC Ratio|1.34|||||TWO_SIDED|95.0|0.94|1.92||||||Serotype 9V: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS).||1.92|0.94|
72480584|NCT00427895|144487425|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMC Ratio|1.33|||||TWO_SIDED|95.0|0.8|2.23||||||Serotype 14: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS).||2.23|0.80|
72480585|NCT00427895|144487425|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMC Ratio|1.04|||||TWO_SIDED|95.0|0.68|1.59||||||Serotype 18C: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS).||1.59|0.68|
72510055|NCT00872170|144550784|SUPERIORITY_OR_OTHER|||||||0.005||95.0|||||Mixed Models Analysis|Linear mixed models with participant-specific intercepts and slopes controlled for time effects were used.||||||0.005
72510056|NCT00872170|144550785|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||Mixed Models Analysis|Linear mixed models with participant-specific intercepts and slopes controlled for time effects were used.||||||0.02
72510057|NCT00872170|144550786|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||Mixed Models Analysis|Linear mixed models with participant-specific intercepts and slopes controlled for time effects were used.||||||0.05
72510058|NCT00872170|144550787|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||Mixed Models Analysis|Linear mixed models with participant-specific intercepts and slopes controlled for time effects were used.||||||0.02
72401145|NCT00768300|144309469|SUPERIORITY_OR_OTHER||Point estimate|2.85||||0.25|TWO_SIDED|95.0|-2.2|7.9||P-value was calculated using the Van Elteren test with strata of baseline presence of PH and whether a SLB was performed with definite or probable UIP based on core pathology review.|Van Elteren test||The point estimate and its 95% CI were based on the Hodges-Lehmann Estimate of treatment effect for percent change from baseline.|||7.90|-2.20|0.250
72401146|NCT00768300|144309470|SUPERIORITY_OR_OTHER||Point estimate|16.0||||0.15|TWO_SIDED|95.0|-5.0|37.0||P-value was calculated using the Van Elteren test with strata of baseline presence of PH and whether a SLB was performed with definite or probable UIP based on core pathology review.|Van Elteren test||The point estimate and 95% CI were based on the Hodges-Lehmann Estimate of treatment effect for percent change from baseline.|||37.00|-5.00|0.150
72401147|NCT00768300|144309473|SUPERIORITY_OR_OTHER||Point estimate|0.5||||0.793|TWO_SIDED|95.0|0.0|1.0||The p-value was based on a Wilcoxon rank sum test stratified by baseline pulmonary hypertension (Yes/No) and surgical lung biopsy was performed with definite or probable UIP based on core pathology review (Yes/No).|Wilcoxon (Mann-Whitney)||The point estimate and 95% confidence interval were based on the Hodges-Lehmann Estimate of treatment effect|||1.00|0.00|0.793
72401148|NCT00624052|144309486|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.88||||||95.0|0.47|1.66|||Cochran-Mantel-Haenszel|||||1.66|0.47|
72401149|NCT00624052|144309486|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.28||||||95.0|0.14|0.59|||Cochran-Mantel-Haenszel|||||0.59|0.14|
72401150|NCT00624052|144309486|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.24||||||95.0|0.12|0.48|||Cochran-Mantel-Haenszel|||||0.48|0.12|
72401151|NCT00624052|144309486|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.32||||||95.0|0.17|0.59|||Cochran-Mantel-Haenszel|||||0.59|0.17|
72480586|NCT00427895|144487425|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMC Ratio|1.15|||||TWO_SIDED|95.0|0.8|1.66||||||Serotype 19A: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS).||1.66|0.80|
72401152|NCT00624052|144309486|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.27||||||95.0|0.15|0.49|||Cochran-Mantel-Haenszel|||||0.49|0.15|
72401153|NCT00624052|144309486|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.84||||||95.0|0.42|1.68|||Cochran-Mantel-Haenszel|||||1.68|0.42|
72401154|NCT02404285|144309500|SUPERIORITY||||||<|0.01|||||||ANOVA|||||||<0.01
72510059|NCT00872170|144550788|SUPERIORITY_OR_OTHER|||||||0.04||95.0|||||Mixed Models Analysis|Linear mixed models with participant-specific intercepts and slopes controlled for time effects were used.||||||0.04
72401155|NCT02404285|144309502|SUPERIORITY||||||<|0.001|||||||ANOVA|||||||<0.001
72401156|NCT00449644|144309548|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|11.77||||0.0034|TWO_SIDED|95.0|2.26|61.23|||Cox proportional hazards model|Treatment, lung cavitation and pooled center were used as covaritates.||||61.23|2.26|0.0034
72401157|NCT00449644|144309549|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.44|||<|0.0001|TWO_SIDED|95.0|1.57|3.8|||Cox proportional hazards model|Treatment, lung cavitation and pooled center were used as covaritates.||||3.80|1.57|<0.0001
72401158|NCT00449644|144309550|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.14||||0.0022|TWO_SIDED|95.0|1.51|6.53|||Cox-proportional hazards model|Treatment, lung cavitation and pooled center were used as covaritates.||||6.53|1.51|0.0022
72401159|NCT00449644|144309551|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.65||||0.029|TWO_SIDED|95.0|1.05|2.59|||Cox proportional hazards model|Treatment, lung cavitation and pooled center were used as covaritates.||MGIT negative (Responders)||2.59|1.05|0.0290
72401160|NCT00449644|144309552|SUPERIORITY_OR_OTHER||Risk Difference (RD)|38.9|STANDARD_ERROR_OF_MEAN|12.38||0.003|TWO_SIDED|95.0|13.97|63.88|||Regression, Logistic|Treatment as covariate||Week 8||63.88|13.97|0.003
72401161|NCT00449644|144309552|SUPERIORITY_OR_OTHER||Risk Difference (RD)|15.7|STANDARD_ERROR_OF_MEAN|13.12||0.237|TWO_SIDED|95.0|-10.7|42.17|||Regression, Logistic|Treatment as covariate||Week 24||42.17|-10.70|0.237
72401162|NCT00449644|144309552|SUPERIORITY_OR_OTHER||Risk Difference (RD)|8.9|STANDARD_ERROR_OF_MEAN|15.02||0.5564|TWO_SIDED|95.0|-21.37|39.18|||Regression, Logistic|Treatment as covariate||Week 104 (Stage 1 Trial End)||39.18|-21.37|0.5564
72401163|NCT00449644|144309553|SUPERIORITY_OR_OTHER||Risk Difference (RD)|21.2|STANDARD_ERROR_OF_MEAN|7.9||0.008|TWO_SIDED|95.0|5.59|36.83|||Regression, Logistic|Treatment as covariate||Week 24||36.83|5.59|0.008
72401164|NCT00449644|144309553|SUPERIORITY_OR_OTHER||Risk Difference (RD)|15.2|STANDARD_ERROR_OF_MEAN|8.27||0.069|TWO_SIDED|95.0|-1.21|31.51|||Regression, Logistic|Treatment as covariate||Week 72||31.51|-1.21|0.069
72401165|NCT00449644|144309553|SUPERIORITY_OR_OTHER||Risk Difference (RD)|18.2|STANDARD_ERROR_OF_MEAN|8.54||0.035|TWO_SIDED|95.0|1.28|35.08|||Regression, Logistic|Treatment as covariate||Week 120||35.08|1.28|0.035
72401166|NCT00853723|144309554|NON_INFERIORITY_OR_EQUIVALENCE|An equivalence test of means for the percentage change in PINP and CTX using two one-sided tests applied to data from the parallel group design with a sample size of 31 in the PTH(1-34) group and 62 in the combined PTHrP(1-36) group achieved 80% power at 2.5% significant level for two-sided hypothesis testing (adjusted for the hypothesis testing at two key endpoints).|||||<|0.0005|TWO_SIDED|||||The reported p-value corresponds with percent change from baseline by day 15 in all three arms.|Kruskal-Wallis|||||||<0.0005
72401167|NCT00853723|144309555|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations for this study were determined considering the expected effects of PTHrP (1-36) relative to PTH (1-34) on the primary endpoints of P1NP and CTX after 3 months of treatment relative to baseline using previously published data as weel as anticipated attrition rate. See primary outcomes.|||||<|0.05|TWO_SIDED|||||The reported p-value corresponds with percent change from baseline in all Arms/groups.|Kruskal-Wallis|The threshold for stasistical significance was p=0.05||||||<0.05
72510060|NCT00872170|144550789|SUPERIORITY_OR_OTHER|||||||0.33||95.0|||||Mixed Models Analysis|Linear mixed models with participant-specific intercepts and slopes controlled for time effects were used.||||||0.33
72480587|NCT00427895|144487425|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMC Ratio|1.79||||||95.0|1.07|3.0||||||Serotype 19F: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS).||3.00|1.07|
72510061|NCT00872170|144550790|SUPERIORITY_OR_OTHER|||||||0.18||95.0|||||Mixed Models Analysis|Linear mixed models with participant-specific intercepts and slopes controlled for time effects were used.||||||0.18
72480588|NCT00427895|144487425|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMC Ratio|1.45|||||TWO_SIDED|95.0|0.95|2.24||||||Serotype 23F: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS).||2.24|0.95|
72480589|NCT00427895|144487425|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMC Ratio|2.18|||||TWO_SIDED|95.0|1.53|3.12||||||Serotype 1: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS/23vPS).||3.12|1.53|
72480590|NCT00427895|144487425|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMC Ratio|1.42|||||TWO_SIDED|95.0|1.06|1.91||||||Serotype 3: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS/23vPS).||1.91|1.06|
72480591|NCT00427895|144487425|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMC Ratio|2.47|||||TWO_SIDED|95.0|1.71|3.55||||||Serotype 4: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS/23vPS).||3.55|1.71|
72480592|NCT00427895|144487425|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMC Ratio|1.99|||||TWO_SIDED|95.0|1.45|2.74||||||Serotype 5: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS/23vPS).||2.74|1.45|
72480593|NCT00427895|144487425|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMC Ratio|2.04|||||TWO_SIDED|95.0|1.5|2.76||||||Serotype 6B: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS/23vPS).||2.76|1.50|
72480594|NCT00427895|144487425|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMC Ratio|1.85|||||TWO_SIDED|95.0|1.32|2.58||||||Serotype 7F: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS/23vPS).||2.58|1.32|
72480595|NCT00427895|144487425|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMC Ratio|1.96|||||TWO_SIDED|95.0|1.46|2.62||||||Serotype 9V: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS/23vPS).||2.62|1.46|
72480596|NCT00427895|144487425|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMC Ratio|1.96|||||TWO_SIDED|95.0|1.32|2.91||||||Serotype 14: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS/23vPS).||2.91|1.32|
72480597|NCT00427895|144487425|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMC Ratio|1.36|||||TWO_SIDED|95.0|0.94|1.97||||||Serotype 18C: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS/23vPS).||1.97|0.94|
72480598|NCT00427895|144487425|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMC Ratio|1.48|||||TWO_SIDED|95.0|1.08|2.03||||||Serotype 19A: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS/23vPS).||2.03|1.08|
72480599|NCT00427895|144487425|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMC Ratio|3.35|||||TWO_SIDED|95.0|2.19|5.12||||||Serotype 19F: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS/23vPS).||5.12|2.19|
72480600|NCT00427895|144487425|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMC Ratio|2.0|||||TWO_SIDED|95.0|1.41|2.83||||||Serotype 23F: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS/23vPS).||2.83|1.41|
72480601|NCT00585195|144487454|SUPERIORITY||Ratio of adjusted geometric means|131.72|||||TWO_SIDED|90.0|96.59|179.63||||||||179.63|96.59|
72480602|NCT00585195|144487454|SUPERIORITY||Ratio of adjusted geometric means|239.03|||||TWO_SIDED|90.0|172.14|331.93||||||||331.93|172.14|
72480603|NCT00585195|144487454|SUPERIORITY||Ratio of adjusted geometric means|201.56|||||TWO_SIDED|90.0|139.33|291.58||||||||291.58|139.33|
72480604|NCT00585195|144487455|SUPERIORITY||Ratio of adjusted geometric means|216.19|||||TWO_SIDED|90.0|161.41|289.56||||||||289.56|161.41|
72480605|NCT00585195|144487455|SUPERIORITY||Ratio of adjusted geometric means|350.0|||||TWO_SIDED|90.0|141.09|868.23||||||||868.23|141.09|
72480606|NCT00585195|144487455|SUPERIORITY||Ratio of adjusted geometric means|365.43|||||TWO_SIDED|90.0|263.22|507.31||||||||507.31|263.22|
72480607|NCT00585195|144487458|SUPERIORITY||Ratio of adjusted geometric mean|15.57|||||TWO_SIDED|90.0|10.89|22.26||||||||22.26|10.89|
72480608|NCT00585195|144487459|SUPERIORITY||Ratio of adjusted geometric mean|20.64|||||TWO_SIDED|90.0|14.59|29.18||||||||29.18|14.59|
72480609|NCT00585195|144487461|SUPERIORITY||Ratio of adjusted geometric means|157.4|||||TWO_SIDED|90.0|136.89|180.97||||||||180.97|136.89|
72480610|NCT00585195|144487462|SUPERIORITY||Ratio of adjusted geometric means|132.81|||||TWO_SIDED|90.0|119.1|148.1||||||||148.10|119.10|
72480611|NCT00822523|144487511|SUPERIORITY_OR_OTHER|||||||0.61|||||||t-test, 2 sided|||Two sample t-test comparing baseline and day 1 H0: There is no change in mean force between baseline and day 1 HA: There is change in mean force between baseline and day 1||||0.61
72480612|NCT00822523|144487511|SUPERIORITY_OR_OTHER|||||||0.787|||||||t-test, 2 sided|||Two sample t-test comparing baseline and day 2 H0: There is no change in mean force between baseline and day 2 HA: There is change in mean force between baseline and day 2||||0.787
72401168|NCT00853723|144309556|NON_INFERIORITY_OR_EQUIVALENCE|An equivalence test of means for the percentage change in PINP and CTX using two one-sided tests applied to data from the parallel group design with a sample size of 31 in the PTH(1-34) group and 62 in the combined PTHrP(1-36) group achieved 80% power at 2.5% significant level for two-sided hypothesis testing (adjusted for the hypothesis testing at two key endpoints).|||||<|0.05|TWO_SIDED|||||The reported p-value corresponds with percent change from baseline at Day 60 and at Day 90 for the PTH group and at day 90 for the PTHrP 400 and PTHrP 600 groups .|Kruskal-Wallis|||||||<0.05
72401169|NCT00853723|144309557|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations for this study were determined considering the expected effects of PTHrP (1-36) relative to PTH (1-34) on the primary endpoints of P1NP and CTX after 3 months of treatment relative to baseline using previously published data as weel as anticipated attrition rate. See primary outcomes.|||||<|0.05|TWO_SIDED|||||The reported p-value corresponds with percent change from baseline in PTHrP 400 and 600 groups.|Kruskal-Wallis|The threshold for stastistical significance was p=0.05||||||<0.05
72401170|NCT00853723|144309558|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations for this study were determined considering the expected effects of PTHrP (1-36) relative to PTH (1-34) on the primary endpoints of P1NP and CTX after 3 months of treatment relative to baseline using previously published data as weel as anticipated attrition rate. See primary outcomes.|||||<|0.05|TWO_SIDED|||||The reported p-value corresponds with percent change from baseline in the PTHrP 400 group|Kruskal-Wallis|The threshold for stastistical significance was p=0.05||||||<0.05
72401171|NCT00853723|144309559|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations for this study were determined considering the expected effects of PTHrP (1-36) relative to PTH (1-34) on the primary endpoints of P1NP and CTX after 3 months of treatment relative to baseline using previously published data as weel as anticipated attrition rate. See primary outcomes.|||||>|0.05|TWO_SIDED|||||The reported p-value corresponds with percent change from baseline in all Arms/groups|Kruskal-Wallis|The threshold for statistical signifcance was p=0.05||||||>0.05
72401172|NCT00853723|144309560|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations for this study were determined considering the expected effects of PTHrP (1-36) relative to PTH (1-34) on the primary endpoints of P1NP and CTX after 3 months of treatment relative to baseline using previously published data as weel as anticipated attrition rate. See primary outcomes.|||||>|0.05|TWO_SIDED|||||The reported p-value corresponds with percent change from baseline in all Arms/groups|Kruskal-Wallis|The threshold for statistical significance was p=0.05||||||>0.05
72401173|NCT00853723|144309561|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations for this study were determined considering the expected effects of PTHrP (1-36) relative to PTH (1-34) on the primary endpoints of P1NP and CTX after 3 months of treatment relative to baseline using previously published data as weel as anticipated attrition rate. See primary outcomes.|||||<|0.0005|TWO_SIDED|||||The reported p-value corresponds to change from baseline at Day 15 and 30 in the PTHrP 400 group and at Day 15 in the PTHrP 600 group|F-test, one way analysis of variance|The threshold for statistical significance was p=0.05||||||<0.0005
72401174|NCT00853723|144309562|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations for this study were determined considering the expected effects of PTHrP (1-36) relative to PTH (1-34) on the primary endpoints of P1NP and CTX after 3 months of treatment relative to baseline using previously published data as weel as anticipated attrition rate. See primary outcomes.|||||<|0.05|TWO_SIDED|||||The reported p-value corresponds to PTH group on Day 60 compared to the PTHrP 400|F-test, one way analysis of variance|The threshold for statistical significance was p=0.05||||||<0.05
72401175|NCT00853723|144309562|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations for this study were determined considering the expected effects of PTHrP (1-36) relative to PTH (1-34) on the primary endpoints of P1NP and CTX after 3 months of treatment relative to baseline using previously published data as weel as anticipated attrition rate. See primary outcomes.|||||<|0.005|TWO_SIDED|||||The reported p-value corresponds to the PTH group on Day 30 compared to the PTHrP 400 group and Day 60 compared to the PTHRp 600 group|Kruskal-Wallis|The threshold for statistical significance was p=0.05||||||<0.005
72401176|NCT00853723|144309562|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations for this study were determined considering the expected effects of PTHrP (1-36) relative to PTH (1-34) on the primary endpoints of P1NP and CTX after 3 months of treatment relative to baseline using previously published data as weel as anticipated attrition rate. See primary outcomes.|||||<|0.0005|TWO_SIDED|||||The reported p-value correspond to the PTH group on Day 15 compared to the PTHrP 400 group and Day 15 and 30 compared to the PTHrP 600 group.|Kruskal-Wallis|The threshold for statistical significance was p=0.05||||||<0.0005
72401177|NCT00853723|144309563|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations for this study were determined considering the expected effects of PTHrP (1-36) relative to PTH (1-34) on the primary endpoints of P1NP and CTX after 3 months of treatment relative to baseline using previously published data as weel as anticipated attrition rate. See primary outcomes.|||||<|0.005|TWO_SIDED|||||The reported p-value corresponds to the increase from baseline to D90 in the PTHrP 400 group.|F-test, one way analysis of variance|the threshold for statistical significance was p=0.05||||||<0.005
72480613|NCT00822523|144487511|SUPERIORITY_OR_OTHER|||||||0.234|||||||t-test, 2 sided|||Two sample t-test comparing baseline and day 4 H0: There is no change in mean force between baseline and day 4 HA: There is change in mean force between baseline and day 4||||0.234
72480614|NCT00822523|144487511|SUPERIORITY_OR_OTHER|||||||0.256|||||||t-test, 2 sided|||Two sample t-test comparing baseline and day 14 H0: There is no change in mean force between baseline and day 14 HA: There is change in mean force between baseline and day 14||||0.256
72480615|NCT00822523|144487511|SUPERIORITY_OR_OTHER|||||||0.292|||||||t-test, 2 sided|||Two sample t-test comparing baseline and day 21 H0: There is no change in mean force between baseline and day 21 HA: There is change in mean force between baseline and day 21||||0.292
72480616|NCT00822523|144487511|SUPERIORITY_OR_OTHER|||||||0.589|||||||t-test, 2 sided|||Two sample t-test comparing baseline and month 4 H0: There is no change in mean force between baseline and month 4 HA: There is change in mean force between baseline and month 4||||0.589
72480617|NCT00822523|144487512|SUPERIORITY_OR_OTHER|||||||0.636|||||||Repeated measure ANOVA|||Repeated measure ANOVA assessing change in the three baseline force measurements H0: There no significant difference in the three baseline force measurements HA: There is a significant difference in the three baseline force measurements||||0.636
72510062|NCT00872170|144550791|SUPERIORITY_OR_OTHER|||||||0.97||95.0|||||Mixed Models Analysis|Linear mixed models with participant-specific intercepts and slopes controlled for time effects were used.||||||0.97
72401178|NCT00853723|144309564|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations for this study were determined considering the expected effects of PTHrP (1-36) relative to PTH (1-34) on the primary endpoints of P1NP and CTX after 3 months of treatment relative to baseline using previously published data as weel as anticipated attrition rate. See primary outcomes.|||||<|0.05|TWO_SIDED|||||The reported p value corresponds to an increased from baseline at all time points in all Arms/groups as well as to the increase in the in the PTHrP 400 group at Day 60 and 90 compared to the PTHrP 600 and PTH groups .|F-test, one way analysis of variance|the threshold for statistical significance was p=0.05||||||<0.05
72401179|NCT00853723|144309564|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations for this study were determined considering the expected effects of PTHrP (1-36) relative to PTH (1-34) on the primary endpoints of P1NP and CTX after 3 months of treatment relative to baseline using previously published data as weel as anticipated attrition rate. See primary outcomes|||||<|0.005|TWO_SIDED|||||The reported p-value corresponds to the comparison of the PTHrP 400 group at Day 15 to the PTHrP 600 and PTH groups|Kruskal-Wallis|The threshold for statistical significance was p=0.05||||||<0.005
72480618|NCT00822523|144487512|SUPERIORITY_OR_OTHER|||||||0.178|||||||Repeated measure ANOVA|||Repeated measure ANOVA assessing change in baseline force by treatment arm. H0: There is no difference in mean baseline force by treatment arm HA: There is a difference in mean baseline force by treatment arm||||0.178
72480619|NCT00822523|144487513|SUPERIORITY_OR_OTHER|||||||0.995|||||||Repeated measure ANOVA|||Repeated measure ANOVA assessing percent change (from baseline) in force for contrast of day 14 and day 21 H0: There is no difference in percent change in force between day 14 and day 21 HA: There is a difference in percent change in force between day 14 and day 21||||0.995
72480620|NCT00822523|144487513|SUPERIORITY_OR_OTHER|||||||0.2088|||||||Repeated measure ANOVA|||"Repeated measure ANOVA assessing percent change in force from baseline for day 14 and 21 by treatment arm.~H0: There is no significant different in percent change in force by treatment arm HA: There is a significant different in percent change in force by treatment arm"||||0.2088
72480621|NCT00822523|144487515|SUPERIORITY_OR_OTHER||r value|0.9||||0.0374|TWO_SIDED||||||Spearman Correlation Test|||Day 4||||0.0374
72480622|NCT00822523|144487515|SUPERIORITY_OR_OTHER||r value|0.7||||0.188|TWO_SIDED||||||Spearman Correlation Test|||Day 14||||0.188
72480623|NCT00822523|144487515|SUPERIORITY_OR_OTHER||r value|0.8||||0.104|TWO_SIDED||||||Spearman Correlation Test|||Month 4||||0.104
72480624|NCT00822523|144487517|SUPERIORITY_OR_OTHER||r value|0.9||||0.0374|TWO_SIDED||||||Spearman Correlation Test|||Day 4||||0.0374
72510063|NCT00872170|144550792|SUPERIORITY_OR_OTHER|||||||0.96||95.0|||||Mixed Models Analysis|Linear mixed models with participant-specific intercepts and slopes controlled for time effects were used.||||||0.96
72480625|NCT00822523|144487517|SUPERIORITY_OR_OTHER||r value|0.7||||0.188|TWO_SIDED||||||Spearman Correlation Test|||Day 14||||0.188
72480626|NCT00822523|144487517|SUPERIORITY_OR_OTHER||r value|0.9||||0.0374|TWO_SIDED||||||Spearman Correlation Test|||Month 4||||0.0374
72480627|NCT00822523|144487518|SUPERIORITY_OR_OTHER||r value|0.9||||0.0374|TWO_SIDED||||||Spearman Correlation Test|||Day 4||||0.0374
72566719|NCT05626803|144664101|SUPERIORITY||||||<|0.0001|||||||ANCOVA|Computed by using ANCOVA model with log transformed data as response variable and treatment as a fixed factor and baseline value as covariate.||||||<.0001
72480628|NCT00822523|144487518|SUPERIORITY_OR_OTHER||r value|0.7||||0.188|TWO_SIDED||||||Spearman Correlation Test|||Day 14||||0.188
72480629|NCT00822523|144487518|SUPERIORITY_OR_OTHER||r value|0.7||||0.188|TWO_SIDED||||||Spearman Correlation Test|||Month 4||||0.188
72480630|NCT00822523|144487519|SUPERIORITY_OR_OTHER||r value|0.9||||0.0374|TWO_SIDED||||||Spearman Correlation Test|||Day 4||||0.0374
72480631|NCT00822523|144487519|SUPERIORITY_OR_OTHER||r value|0.7||||0.188|TWO_SIDED||||||Spearman Correlation Test|||Day 14||||0.188
72480632|NCT00822523|144487519|SUPERIORITY_OR_OTHER||r value|0.5||||0.391|TWO_SIDED||||||Spearman Correlation Test|||Month 4||||0.391
72480633|NCT00822523|144487520|SUPERIORITY_OR_OTHER||r value|0.9||||0.0374|TWO_SIDED||||||Spearman Correlation Test|||Day 4||||0.0374
72480634|NCT00822523|144487520|SUPERIORITY_OR_OTHER||r value|0.7||||0.188|TWO_SIDED||||||Spearman Correlation Test|||Day 14||||0.188
72480635|NCT00822523|144487520|SUPERIORITY_OR_OTHER||r value|0.9||||0.0374|TWO_SIDED||||||Spearman Correlation Test|||Month 4||||0.0374
72480636|NCT00822523|144487521|SUPERIORITY_OR_OTHER||r value|0.9||||0.0374|TWO_SIDED||||||Spearman Correlation Test|||Day 4||||0.0374
72480637|NCT00822523|144487521|SUPERIORITY_OR_OTHER||r value|0.7||||0.188|TWO_SIDED||||||Spearman Correlation Test|||Day 14||||0.188
72480638|NCT00822523|144487521|SUPERIORITY_OR_OTHER||r value|0.4||||0.505|TWO_SIDED||||||Spearman Correlation Test|||Month 4||||0.505
72480639|NCT00822523|144487522|SUPERIORITY_OR_OTHER||r value|0.99|||<|0.0001|TWO_SIDED||||||Spearman Correlation Test|||Day 4||||<0.0001
72480640|NCT00822523|144487522|SUPERIORITY_OR_OTHER||r value|0.9||||0.0374|TWO_SIDED||||||Spearman Correlation Test|||Day 14||||0.0374
72480641|NCT00822523|144487522|SUPERIORITY_OR_OTHER||r value|0.8||||0.104|TWO_SIDED||||||Spearman Correlation Test|||Month 4||||0.104
72480642|NCT00822523|144487523|SUPERIORITY_OR_OTHER||r value|0.99|||<|0.0001|TWO_SIDED||||||Spearman Correlation Test|||Day 4||||<0.0001
72480643|NCT00822523|144487523|SUPERIORITY_OR_OTHER||r value|0.9||||0.0374|TWO_SIDED||||||Spearman Correlation Test|||Day 14||||0.0374
72510064|NCT01721408|144550793|NON_INFERIORITY_OR_EQUIVALENCE|Assuming that the 2 treatments were equally effective, with cure rates of 75 % at the TOC assessment, the study was powered to ensure with 90% probability that the lower limit of a 2-sided 95% confidence interval (CI) for the true difference (tigecycline minus imipenem/cilastatin) in cure rates was greater than -15%.|Difference in percentage|-6.7||||0.0008|TWO_SIDED|95.0|-12.0|-1.4|||See method of CI||Used the asymptotic method corrected for continuity with normal distribution approximation. Non-inferiority test was conducted on the CE population. If non-inferiority was concluded, superiority test was conducted on both the CE and mITT populations.|||-1.4|-12.0|0.0008
72510065|NCT01721408|144550794|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was concluded if the lower limit of the 2-sided CI for the difference in cure rates between treatment groups (tigecycline minus imipenem/cilastatin) was greater than -15%.|Difference in percentage|-7.3||||0.0277|TWO_SIDED|95.0|-15.2|0.5|||See method of CI||CIs and p-values for between-group treatment difference in cure rate were calculated by the asymptotic method corrected for continuity with normal distribution approximation.|||0.5|-15.2|0.0277
72401180|NCT00853723|144309565|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations for this study were determined considering the expected effects of PTHrP (1-36) relative to PTH (1-34) on the primary endpoints of P1NP and CTX after 3 months of treatment relative to baseline using previously published data as weel as anticipated attrition rate.|||||<|0.05|TWO_SIDED|||||The reported p-value corresponds to an increase compared to baseline in the PTHrP 600 group at D15 and D30|F-test, one way analysis of variance|The threshold for stastistical significance was p=0.05||||||<0.05
72401181|NCT00853723|144309565|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations for this study were determined considering the expected effects of PTHrP (1-36) relative to PTH (1-34) on the primary endpoints of P1NP and CTX after 3 months of treatment relative to baseline using previously published data as weel as anticipated attrition rate.|||||<|0.005|TWO_SIDED|||||the reported p-value corresponds to change from baseline in the PTHrP 400 group at Day 15,30, 60 and 90 and the PTH group at day 90.|Kruskal-Wallis|the threshold for statistical significance was p=0.05||||||<0.005
72401182|NCT00853723|144309566|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations for this study were determined considering the expected effects of PTHrP (1-36) relative to PTH (1-34) on the primary endpoints of P1NP and CTX after 3 months of treatment relative to baseline using previously published data as weel as anticipated attrition rate. See primary outcomes.|||||<|0.05|TWO_SIDED|||||The reported p-value corresponds the PTH group on Day 15 compared to the PTHrP 400 group and to the PTHrP 600 group at Day 30 and Day 60|Kruskal-Wallis|The threshold for statistical significance was p=0.05||||||<0.05
72401183|NCT00853723|144309566|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations for this study were determined considering the expected effects of PTHrP (1-36) relative to PTH (1-34) on the primary endpoints of P1NP and CTX after 3 months of treatment relative to baseline using previously published data as weel as anticipated attrition rate.|||||<|0.0005|TWO_SIDED|||||Thre reported p-value correspond to the PTH group compared to the PTHrp 600 group at day 15|Kruskal-Wallis|the threshold for statistical significance was p=0.05||||||<0.0005
72401184|NCT03245008|144309579|SUPERIORITY||Least Squares Mean Difference|-1.22|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|95.0|-1.57|-0.86||Adjusted P-value|Mixed Models Analysis|||||-0.86|-1.57|<0.001
72401185|NCT03245008|144309579|SUPERIORITY||Least Squares Mean Difference|-0.34|STANDARD_ERROR_OF_MEAN|0.21||0.103|TWO_SIDED|95.0|-0.76|0.07||Adjusted P-value|Mixed Models Analysis|||||0.07|-0.76|0.103
72401186|NCT03245008|144309580|SUPERIORITY||Least Squares Mean Difference|-1.26|STANDARD_ERROR_OF_MEAN|0.17|<|0.001|TWO_SIDED|95.0|-1.6|-0.92||Adjusted P-value|Mixed Models Analysis|||||-0.92|-1.60|<0.001
72401187|NCT03245008|144309580|SUPERIORITY||Least Squares Mean Difference|-0.45|STANDARD_ERROR_OF_MEAN|0.2|||TWO_SIDED|95.0|-0.84|-0.05||||||||-0.05|-0.84|
72401188|NCT01286012|144309588|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0|||||ANCOVA|||||||<0.05
72401189|NCT01286012|144309589|SUPERIORITY_OR_OTHER|||||||0.915|||||||Cochran-Mantel-Haenszel|||||||0.915
72401190|NCT01286012|144309590|SUPERIORITY_OR_OTHER|||||||0.6714|||||||Cochran-Mantel-Haenszel|||||||0.6714
72401191|NCT01286012|144309591|SUPERIORITY_OR_OTHER|||||||0.028|||||||Wilcoxon (Mann-Whitney)|||||||0.028
72401192|NCT01286012|144309592|SUPERIORITY_OR_OTHER|||||||0.361|||||||Wilcoxon (Mann-Whitney)|||||||0.361
72401193|NCT00483223|144309613|OTHER|||||||0.54|||||||t-test, 2 sided|||H0: no association between expression ratio and response rate Ha: Participants with expression ratio greater than 2 would have higher response rate||||0.54
72401194|NCT03759379|144309616|EQUIVALENCE|H0: No difference between vutrisiran and external placebo comparator (APOLLO): difference (vutrisiran - placebo) = 0|LS Mean Difference|-17.0|STANDARD_ERROR_OF_MEAN|2.44|<|1e-07|TWO_SIDED|95.0|-21.78|-12.22||P=3.542E-12|ANCOVA with Multiple Imputation|||Multiple imputation estimates and p-value derived per combining least squares (LS) estimates per Rubin's rules based on 100 datasets where missing Month 9 values were imputed using a regression procedure including select baseline variables. LS estimates derived from analysis of covariance model, controlling for categorical factors (treatment, genotype, age of disease onset) and continuous covariate (baseline value).||-12.22|-21.78|<0.0000001
72401195|NCT03759379|144309617|EQUIVALENCE|H0: No difference between vutrisiran and external placebo comparator (APOLLO): difference (vutrisiran - placebo) = 0|LS Mean Difference|-16.2|STANDARD_ERROR_OF_MEAN|2.8|<|1e-07|TWO_SIDED|95.0|-21.7|-10.8||P=5.426E-09|ANCOVA with Multiple Imputation|||Multiple imputation estimates and p-value derived per combining least squares (LS) estimates per Rubin's rules based on 100 datasets where missing Month 9 values were imputed using a regression procedure including select baseline variables. LS estimates derived from analysis of covariance model, controlling for categorical factors (treatment, genotype, age of disease onset baseline NIS) and continuous covariate (baseline value).||-10.8|-21.7|<0.0000001
72401196|NCT03759379|144309618|EQUIVALENCE|H0: No difference between vutrisiran and external placebo comparator (APOLLO): difference (vutrisiran - placebo) = 0|LS Mean Difference|0.131|STANDARD_ERROR_OF_MEAN|0.031|<|1e-07|TWO_SIDED|95.0|0.07|0.193||P=3.103E-05|ANCOVA with Multiple Imputation|||Multiple imputation estimates and p-value derived per combining least squares (LS) estimates per Rubin's rules based on 100 datasets where missing Month 9 values were imputed using a regression procedure including select baseline variables. LS estimates derived from analysis of covariance model, controlling for categorical factors (treatment, genotype, age of disease onset, baseline NIS) and continuous covariate (baseline value).||0.193|0.070|<0.0000001
72401197|NCT01536379|144309642|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-34.4|STANDARD_ERROR_OF_MEAN|37.24|||TWO_SIDED|95.0|-109.5|40.7||||||||40.7|-109.5|
72401198|NCT01536379|144309663|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|204.35|||||TWO_SIDED|95.0|90.0|550.0|||||Week 24 comparison|||550.00|90.00|
72401199|NCT01536379|144309663|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-33.06|||||TWO_SIDED|95.0|-169.84|25.0|||||Week 52 comparison|||25.00|-169.84|
72401200|NCT01536379|144309664|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1232.4|STANDARD_ERROR_OF_MEAN|25735.56|||TWO_SIDED|95.0|-50457.0|52921.8|||||Week 24 comparison|||52921.8|-50457.0|
72401201|NCT01536379|144309664|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13128.35|STANDARD_ERROR_OF_MEAN|24165.18|||TWO_SIDED|95.0|-61868.9|35612.2|||||Week 52 comparison|||35612.2|-61868.9|
72401202|NCT01536379|144309665|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.8|STANDARD_ERROR_OF_MEAN|8.78|||TWO_SIDED|95.0|-31.3|3.7|||||Week 24 comparison|||3.7|-31.3|
72401203|NCT01536379|144309665|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.8|STANDARD_ERROR_OF_MEAN|7.68|||TWO_SIDED|95.0|-8.6|22.2|||||Week 52 comparison|||22.2|-8.6|
72401204|NCT01536379|144309666|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2791.0|STANDARD_ERROR_OF_MEAN|4651.1|||TWO_SIDED|95.0|-12105.0|6524.0|||||Week 24 comparison|||6524|-12105|
72623933|NCT00721110|144778300|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.6||||0.2|TWO_SIDED|97.5|-0.9|2.2||97.5% confidence intervals (CIs) adjusted for group sequential design (using confidence coefficient of 2.97) to maintain the overall α of 0.025 for each intervention and 0.05 for the trial.|t-test, 2 sided|||Lidocaine versus nonlidocaine on postoperative day 1 pain severity assessed using a t test.||2.2|-0.9|0.20
72480644|NCT00822523|144487523|SUPERIORITY_OR_OTHER||r value|0.9||||0.0374|TWO_SIDED||||||Spearman Correlation Test|||Month 4||||0.0374
72623934|NCT00721110|144778300|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||0.79|TWO_SIDED|97.5|-1.4|1.7||97.5% confidence intervals (CIs) adjusted for group sequential design (using confidence coefficient of 2.97) to maintain the overall α of 0.025 for each intervention and 0.05 for the trial.|t-test, 2 sided|||Ketamine versus nonketamine on postoperative day 1 pain severity was assessed using a t test.||1.7|-1.4|0.79
72623935|NCT00721110|144778300|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3||||0.55|TWO_SIDED|97.5|-1.1|1.7||97.5% confidence intervals (CIs) adjusted for group sequential design (using confidence coefficient of 2.97) to maintain the overall α of 0.025 for each intervention and 0.05 for the trial.|t-test, 2 sided|||Lidocaine versus nonlidocaine on postoperative day 2 pain severity was assessed using a t test.||1.7|-1.1|0.55
72623936|NCT00721110|144778300|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3||||0.47|TWO_SIDED|97.5|-1.1|1.8||97.5% confidence intervals (CIs) adjusted for group sequential design (using confidence coefficient of 2.97) to maintain the overall α of 0.025 for each intervention and 0.05 for the trial.|t-test, 2 sided|||Ketamine versus nonketamine on postoperative day 2 pain severity was assessed using a t test.||1.8|-1.1|0.47
72623937|NCT00721110|144778301|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.63|TWO_SIDED|97.5|-7.0|7.0||97.5% confidence intervals (CIs) adjusted for group sequential design (using confidence coefficient of 2.97) to maintain the overall α of 0.025 for each intervention and 0.05 for the trial.|Wilcoxon (Mann-Whitney)|||Lidocaine versus nonlidocaine on intraoperative opioid consumption was assessed using the Wilcoxon rank sum test.||7|-7|0.63
72623938|NCT00721110|144778301|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-2.0||||0.27|TWO_SIDED|97.5|-10.0|5.0||97.5% confidence intervals (CIs) adjusted for group sequential design (using confidence coefficient of 2.97) to maintain the overall α of 0.025 for each intervention and 0.05 for the trial.|Wilcoxon (Mann-Whitney)|||Ketamine versus nonketamine on intraoperative opioid consumption was assessed using a Wilcoxon rank sum test.||5|-10|0.27
72623939|NCT00721110|144778301|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-3.0||||0.28|TWO_SIDED|97.5|-15.0|5.0||97.5% confidence intervals (CIs) adjusted for group sequential design (using confidence coefficient of 2.97) to maintain the overall α of 0.025 for each intervention and 0.05 for the trial.|Wilcoxon (Mann-Whitney)|||Lidocaine versus nonlidocaine on postoperative care unit opioid consumption was assessed using a Wilcoxon rank sum test.||5|-15|0.28
72623940|NCT00721110|144778301|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-4.0||||0.22|TWO_SIDED|97.5|-15.0|4.0||97.5% confidence intervals (CIs) adjusted for group sequential design (using confidence coefficient of 2.97) to maintain the overall α of 0.025 for each intervention and 0.05 for the trial.|Wilcoxon (Mann-Whitney)|||Ketamine versus nonketamine on postoperative care unit opioid consumption was assessed using a Wilcoxon rank sum test.||4|-15|0.22
72623941|NCT00721110|144778301|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|2.5||||0.76|TWO_SIDED|97.5|-13.0|21.0||97.5% confidence intervals (CIs) adjusted for group sequential design (using confidence coefficient of 2.97) to maintain the overall α of 0.025 for each intervention and 0.05 for the trial.|Wilcoxon (Mann-Whitney)|||Lidocaine versus nonlidocaine on postoperative day 1 opioid consumption was assessed using a Wilcoxon rank sum test.||21|-13|0.76
72401205|NCT01536379|144309666|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-458.0|STANDARD_ERROR_OF_MEAN|4501.8|||TWO_SIDED|95.0|-9487.0|8572.0|||||Week 52 comparison|||8572|-9487|
72401206|NCT01536379|144309667|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.29|STANDARD_ERROR_OF_MEAN|1.156|||TWO_SIDED|95.0|-3.59|1.01|||||Week 24 comparison|||1.01|-3.59|
72480645|NCT00822523|144487524|SUPERIORITY_OR_OTHER||r value|0.99|||<|0.0001|TWO_SIDED||||||Spearman Correlation Test|||Day 4||||<0.0001
72480646|NCT00822523|144487524|SUPERIORITY_OR_OTHER||r value|0.9||||0.0374|TWO_SIDED||||||Spearman Correlation Test|||Day 14||||0.0374
72480647|NCT00822523|144487524|SUPERIORITY_OR_OTHER||r value|0.7||||0.188|TWO_SIDED||||||Spearman Correlation Test|||Month 4||||0.188
72623942|NCT00721110|144778301|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-3.0||||0.66|TWO_SIDED|97.5|-19.0|14.0||97.5% confidence intervals (CIs) adjusted for group sequential design (using confidence coefficient of 2.97) to maintain the overall α of 0.025 for each intervention and 0.05 for the trial.|Wilcoxon (Mann-Whitney)|||Ketamine versus nonketamine on postoperative day 1 opioid consumption was assessed using a Wilcoxon rank sum test.||14|-19|0.66
72623943|NCT00721110|144778301|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|2.5||||0.3|TWO_SIDED|97.5|-5.0|10.0||97.5% confidence intervals (CIs) adjusted for group sequential design (using confidence coefficient of 2.97) to maintain the overall α of 0.025 for each intervention and 0.05 for the trial.|Wilcoxon (Mann-Whitney)|||Lidocaine versus nonlidocaine on postoperative day 2 opioid consumption was assessed using a Wilcoxon rank sum test.||10|-5|0.30
72623944|NCT00721110|144778301|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.79|TWO_SIDED|97.5|-5.0|8.0||97.5% confidence intervals (CIs) adjusted for group sequential design (using confidence coefficient of 2.97) to maintain the overall α of 0.025 for each intervention and 0.05 for the trial.|Wilcoxon (Mann-Whitney)|||Ketamine versus nonketamine on postoperative day 2 opioid consumption was assessed using a Wilcoxon rank sum test.||8|-5|0.79
72623945|NCT00721110|144778302|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.06||||0.58|TWO_SIDED|97.5|-0.28|0.41||97.5% confidence intervals (CIs) adjusted for group sequential design (using confidence coefficient of 2.97) to maintain the overall α of 0.025 for each intervention and 0.05 for the trial.|Chi-squared||numerator: lidocaine; denominator: control|Lidocaine versus nonlidocaine on PACU (postoperative care unit) nausea assessed using Pearson chi square test.||0.41|-0.28|0.58
72401207|NCT01536379|144309667|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.79|STANDARD_ERROR_OF_MEAN|1.017|||TWO_SIDED|95.0|-1.24|2.82|||||Week 52 comparison|||2.82|-1.24|
72401208|NCT01536379|144309668|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-30326.9|STANDARD_ERROR_OF_MEAN|34677.86|||TWO_SIDED|95.0|-100559.1|39905.3|||||Week 24 comparison|||39905.3|-100559.1|
72401209|NCT01536379|144309668|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-46955.3|STANDARD_ERROR_OF_MEAN|32594.81|||TWO_SIDED|95.0|-113218.9|19308.3|||||Week 52 comparison|||19308.3|-113218.9|
72480648|NCT00822523|144487525|SUPERIORITY_OR_OTHER||r value|0.99|||<|0.0001|TWO_SIDED||||||Spearman Correlation Test|||Day 4||||<0.0001
72480649|NCT00822523|144487525|SUPERIORITY_OR_OTHER||r value|0.9||||0.0374|TWO_SIDED||||||Spearman Correlation Test|||Day 14||||0.0374
72480650|NCT00822523|144487525|SUPERIORITY_OR_OTHER||r value|0.5||||0.391|TWO_SIDED||||||Spearman Correlation Test|||Month 4||||0.391
72480651|NCT00822523|144487526|SUPERIORITY_OR_OTHER||r value|0.99|||<|0.0001|TWO_SIDED||||||Spearman Correlation Test|||Day 4||||<0.0001
72480652|NCT00822523|144487526|SUPERIORITY_OR_OTHER||r value|0.9||||0.0374|TWO_SIDED||||||Spearman Correlation Test|||Day 14||||0.0374
72480653|NCT00822523|144487526|SUPERIORITY_OR_OTHER||r value|0.9||||0.0374|TWO_SIDED||||||Spearman Correlation Test|||Month 4||||0.0374
72480654|NCT00822523|144487527|SUPERIORITY_OR_OTHER||r value|0.99|||<|0.0001|TWO_SIDED||||||Spearman Correlation Test|||Day 4||||<0.0001
72480655|NCT00822523|144487527|SUPERIORITY_OR_OTHER||r value|0.9||||0.0374|TWO_SIDED||||||Spearman Correlation Test|||Day 14||||0.0374
72480656|NCT00822523|144487527|SUPERIORITY_OR_OTHER||r value|0.4||||0.505|TWO_SIDED||||||Spearman Correlation Test|||Month 4||||0.505
72480657|NCT02881957|144487548|SUPERIORITY|||||||0.2|||||||t-test, 2 sided|||Two-sided t-test evaluated comparing length of stay in vitamin D3 vs. placebo treated patients utilizing patients as randomized (e.g., intent-to-treat) using a p\<0.05 as significant. Adverse events were monitored until discharge.||||0.2
72480658|NCT02881957|144487549|SUPERIORITY|||||||0.4|||||||t-test, 2 sided|||||||0.4
72480659|NCT02881957|144487550|SUPERIORITY|||||||0.3|||||||t-test, 2 sided|||||||0.3
72480660|NCT02881957|144487551|SUPERIORITY|||||||0.6|||||||t-test, 2 sided|||||||0.6
72480661|NCT02881957|144487552|SUPERIORITY|||||||0.7|||||||Chi-squared|||||||0.7
72480662|NCT02881957|144487553|SUPERIORITY|||||||0.99|||||||Chi-squared|||Adverse events were monitored until patient discharge from the hospital.||||0.99
72480663|NCT02881957|144487554|SUPERIORITY|||||||0.6|||||||Chi-squared|||Adverse events were monitored until patient discharge from the hospital.||||0.6
72566720|NCT05626803|144664101|SUPERIORITY|||||||0.0017|||||||ANCOVA|Computed by using ANCOVA model with log transformed data as response variable and treatment as a fixed factor and baseline value as covariate.||||||0.0017
72480664|NCT02881957|144487555|SUPERIORITY|||||||0.7|||||||Chi-squared|||Adverse events were monitored until patient discharge from the hospital.||||0.7
72480665|NCT02881957|144487556|SUPERIORITY|||||||0.4|||||||Chi-squared|||Adverse events were monitored until patient discharge from the hospital.||||0.4
72480666|NCT02881957|144487557|SUPERIORITY|||||||0.1|||||||Chi-squared|||Adverse events were monitored until patient discharge from the hospital.||||0.1
72401210|NCT01536379|144309669|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.0|STANDARD_ERROR_OF_MEAN|3.54|||TWO_SIDED|95.0|-10.1|4.2|||||Week 24 comparison|||4.2|-10.1|
72401211|NCT01536379|144309669|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|3.35|||TWO_SIDED|95.0|-7.2|6.3|||||Week 52 comparison|||6.3|-7.2|
72480667|NCT05269355|144487558|OTHER||Hazard Ratio (HR)|0.61||||0.0017|TWO_SIDED|95.0|0.45|0.83|||Regression, Cox|||||0.83|0.45|0.0017
72480668|NCT00081497|144487564|SUPERIORITY_OR_OTHER||Change in Slope Mean|-0.029||||0.013||95.0|-0.051|-0.007|||Mixed Models Analysis|Mixed effects model with a population level (fixed effect) intercept and slope and a subject level (random effect) intercept and slope.||The statistical analysis represents the primary outcome measure results.||-0.007|-0.051|0.0130
72480669|NCT00081497|144487565|SUPERIORITY_OR_OTHER||Mean Difference|-6.787||||0.0027||95.0|-11.123|-2.45|||Mixed Effects Model|||Statistical Analysis 1 represents the post-hoc outcome results for difference in slope mean of eGFR subgroup \>60.||-2.450|-11.123|0.0027
72480670|NCT00081497|144487565|SUPERIORITY_OR_OTHER||Mean Difference|2.33||||0.1268||95.0|-0.685|5.345|||Mixed Effects Model|||Statistical Analysis 2 represents the post-hoc outcome results for difference in slope mean of eGFR subgroup ≤ 60.||5.345|-0.685|0.1268
72480671|NCT04281004|144487603|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.000
72480672|NCT04281004|144487604|SUPERIORITY|||||||0.869|||||||Mixed Models Analysis|Mixed model analysis is used to account for correlation between eyes in the same participant.||||||0.869
72480673|NCT04281004|144487605|SUPERIORITY|||||||0.007||||||Significance of treatment effect at month 1.|Mixed Models Analysis|Mixed model analysis is used to account for correlation between eyes in the same participant.||||||0.007
72480674|NCT04281004|144487605|SUPERIORITY|||||||0.953||||||Significance of treatment effect at month 3.|Mixed Models Analysis|Mixed model analysis is used to account for correlation between eyes in the same participant.||||||0.953
72401212|NCT01536379|144309670|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|648.3|STANDARD_ERROR_OF_MEAN|12618.44|||TWO_SIDED|95.0|-24661.1|25957.7|||||Week 24 comparison|||25957.7|-24661.1|
72401213|NCT01536379|144309670|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5618.9|STANDARD_ERROR_OF_MEAN|12153.03|||TWO_SIDED|95.0|-29994.8|18757.0|||||Week 52 comparison|||18757.0|-29994.8|
72480675|NCT04281004|144487605|SUPERIORITY|||||||0.841||||||Significance of treatment effect at month 6.|Mixed Models Analysis|Mixed model analysis is used to account for correlation between eyes in the same participant.||||||0.841
72480676|NCT04281004|144487605|SUPERIORITY|||||||0.137||||||Significance of treatment effect at month 12.|Mixed Models Analysis|Mixed model analysis is used to account for correlation between eyes in the same participant.||||||0.137
72480677|NCT04281004|144487606|SUPERIORITY|||||||0.614|||||||t-test, 2 sided|||||||0.614
72480678|NCT04281004|144487607|SUPERIORITY|||||||0.594|||||||Fisher Exact|||||||0.594
72480679|NCT04281004|144487608|SUPERIORITY|||||||0.663||||||Significance of treatment effect at month 1.|Wilcoxon (Mann-Whitney)|Clustered version of the Wilcoxon test||||||0.663
72566721|NCT05626803|144664103|SUPERIORITY||||||<|0.0001|||||||ANCOVA|Computed by using ANCOVA model with log transformed data as response variable and treatment as a fixed factor and baseline value as covariate.||||||<.0001
72401214|NCT01536379|144309671|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|1.67|||TWO_SIDED|95.0|-3.2|3.5|||||Week 24 comparison|||3.5|-3.2|
72401215|NCT01536379|144309671|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|1.45|||TWO_SIDED|95.0|-3.5|2.3|||||Week 52 comparison|||2.3|-3.5|
72480680|NCT04281004|144487608|SUPERIORITY|||||||0.416||||||Significance of treatment effect at month 3.|Wilcoxon (Mann-Whitney)|Clustered version of the Wilcoxon test||||||0.416
72566722|NCT05626803|144664103|SUPERIORITY||||||<|0.0001|||||||ANCOVA|Computed by using ANCOVA model with log transformed data as response variable and treatment as a fixed factor and baseline value as covariate.||||||<.0001
72566723|NCT05626803|144664103|SUPERIORITY||||||<|0.0001|||||||ANCOVA|Computed by using ANCOVA model with log transformed data as response variable and treatment as a fixed factor and baseline value as covariate.||||||<.0001
72566724|NCT05626803|144664105|SUPERIORITY|||||||0.0059|||||||ANCOVA|Computed by using ANCOVA model with log transformed data as response variable and treatment as a fixed factor and baseline value as covariate.||||||0.0059
72566725|NCT05626803|144664105|SUPERIORITY|||||||0.002|||||||ANCOVA|Computed by using ANCOVA model with log transformed data as response variable and treatment as a fixed factor and baseline value as covariate.||||||0.0020
72566726|NCT05626803|144664105|SUPERIORITY|||||||0.1899|||||||ANCOVA|Computed by using ANCOVA model with log transformed data as response variable and treatment as a fixed factor and baseline value as covariate.||||||0.1899
72566727|NCT05626803|144664107|SUPERIORITY||||||<|0.0001|||||||ANCOVA|Computed by using ANCOVA model with log transformed data as response variable and treatment as a fixed factor and baseline value as covariate.||||||<.0001
72566728|NCT05626803|144664107|SUPERIORITY||||||<|0.0001|||||||ANCOVA|Computed by using ANCOVA model with log transformed data as response variable and treatment as a fixed factor and baseline value as covariate.||||||<.0001
72566729|NCT05626803|144664107|SUPERIORITY|||||||0.002|||||||ANCOVA|Computed by using ANCOVA model with log transformed data as response variable and treatment as a fixed factor and baseline value as covariate.||||||0.0020
72566730|NCT04843566|144664156|SUPERIORITY|||||||0.04|||||||Fisher Exact|||Infection||||0.04
72566731|NCT04843566|144664156|SUPERIORITY|||||||0.3|||||||Fisher Exact|||Urinary retention||||0.30
72566732|NCT04843566|144664156|SUPERIORITY|||||||0.31|||||||Fisher Exact|||Bleeding requiring intervention||||0.31
72401216|NCT01536379|144309672|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.54|STANDARD_ERROR_OF_MEAN|1.255|||TWO_SIDED|95.0|-4.07|0.98|||||Week 24 comparison|||0.98|-4.07|
72401217|NCT01536379|144309672|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.01|STANDARD_ERROR_OF_MEAN|1.329|||TWO_SIDED|95.0|-3.68|1.67|||||Week 52 comparison|||1.67|-3.68|
72401218|NCT01536379|144309673|SUPERIORITY_OR_OTHER||Difference in Proportion|-0.067|||||TWO_SIDED|95.0|-0.638|0.505|||||Week 24 comparison|||0.505|-0.638|
72401219|NCT01536379|144309673|SUPERIORITY_OR_OTHER||Difference in Proportion|-0.267|||||TWO_SIDED|95.0|-0.838|0.305|||||Week 52 comparison|||0.305|-0.838|
72566733|NCT04843566|144664157|SUPERIORITY|||||||0.002|||||||t-test, 2 sided|||Immediately following biopsy - Pain||||0.002
72566734|NCT04843566|144664157|SUPERIORITY|||||||0.05|||||||t-test, 2 sided|||Immediately following biopsy - Discomfort||||0.05
72566735|NCT04843566|144664157|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||7-day post biopsy - Pain||||<0.0001
72566736|NCT04843566|144664157|SUPERIORITY|||||||0.07|||||||t-test, 2 sided|||7-day post biopsy - Discomfort||||0.07
72566737|NCT04843566|144664158|SUPERIORITY|||||||0.23|||||||t-test, 2 sided|||||||0.23
72566738|NCT04843566|144664159|SUPERIORITY|||||||0.59|||||||Chi-squared|||Gleason grade \>=2||||0.59
72566739|NCT04843566|144664160|SUPERIORITY|||||||0.04|||||||Fisher Exact|||Infection||||0.04
72566740|NCT04843566|144664160|SUPERIORITY|||||||0.3|||||||Fisher Exact|||Urinary retention||||0.30
72566741|NCT04843566|144664160|SUPERIORITY|||||||0.31|||||||Fisher Exact|||Bleeding requiring intervention||||0.31
72566742|NCT03861481|144664216|SUPERIORITY||LS Mean difference (Rozimab - Placebo)|-0.052|||||TWO_SIDED|90.0|-0.892|0.788|||||MMRM analysis (fixed effect terms: treatment, baseline iRODS score, prior Ig therapy administration route, assessment week, treatment by week interaction; random effect term: study participant). LS Mean Difference \> 0 favours rozanolixizumab.|||0.788|-0.892|
72566743|NCT01287039|144664225|SUPERIORITY_OR_OTHER_LEGACY||CAE rate ratio (reslizumab vs placebo)|0.501|||<|0.0001|TWO_SIDED|95.0|0.3726|0.6737||The treatment effect was tested using the likelihood based Chi-square test at the 0.05 significance level.|Chi-squared|||The frequency of CAEs was analyzed using the generalized linear model (GLM) for data from the negative binomial distributions that is commonly referred to as the negative binomial (NB) regression model. The primary NB model included the treatment group and randomization stratification factors as model factors and the logarithm of follow up time excluding the summed duration of exacerbations in the treatment period as an offset variable.||0.6737|0.3726|<0.0001
72566744|NCT01287039|144664226|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.137|STANDARD_ERROR_OF_MEAN|0.0311|<|0.0001|TWO_SIDED|95.0|0.076|0.198|||Mixed Model Repeated Measures|||For each week and overall change, inferential statistics were from mixed model repeated measures (MMRM) with treatment, visit, treatment by visit interaction, region, oral glucocorticosteroids use at enrollment and sex as fixed factors, and covariates for height and baseline value and patient as a random effect. Unstructured covariance structure was assumed for the repeated measures.||0.198|0.076|<0.0001
72566745|NCT01287039|144664227|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.238|STANDARD_ERROR_OF_MEAN|0.0967||0.0143|TWO_SIDED|95.0|0.048|0.428|||Mixed model repeated measures|||For each week and overall change, inferential statistics were from mixed model repeated measures (MMRM) with treatment, visit, treatment by visit interaction, region, oral glucocorticosteroids use at enrollment and sex as fixed factors, and covariates for height and baseline value and patient as a random effect. Unstructured covariance structure was assumed for the repeated measures.||0.428|0.048|0.0143
72566746|NCT01287039|144664228|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.266|STANDARD_ERROR_OF_MEAN|0.0681||0.0001|TWO_SIDED|95.0|-0.399|-0.132|||Mixed model repeated measures|||For each week and overall change, inferential statistics were from mixed model repeated measures (MMRM) with treatment, visit, treatment by visit interaction, region, oral glucocorticosteroids use at enrollment and sex as fixed factors, and covariates for height and baseline value and patient as a random effect. Unstructured covariance structure was assumed for the repeated measures.||-0.132|-0.399|0.0001
72401220|NCT01536379|144309674|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.8|STANDARD_ERROR_OF_MEAN|52.06|||TWO_SIDED|95.0|-105.9|100.3|||||Week 24 comparison|||100.3|-105.9|
72401221|NCT01536379|144309674|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.9|STANDARD_ERROR_OF_MEAN|47.52|||TWO_SIDED|95.0|-107.1|81.4|||||Week 52 comparison|||81.4|-107.1|
72401222|NCT01536379|144309675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.92|STANDARD_ERROR_OF_MEAN|9.44|||TWO_SIDED|95.0|-31.56|5.71|||||Week 24 comparison|||5.71|-31.56|
72401223|NCT01536379|144309675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.7|STANDARD_ERROR_OF_MEAN|8.315|||TWO_SIDED|95.0|-19.11|13.72|||||Week 52 comparison|||13.72|-19.11|
72401224|NCT01536379|144309676|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.44|STANDARD_ERROR_OF_MEAN|2.225|||TWO_SIDED|95.0|-4.84|3.96||||||||3.96|-4.84|
72566747|NCT01287039|144664229|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|0.575|||<|0.0001|TWO_SIDED|95.0|0.44|0.75|||Regression, Cox|Stratified by baseline usage of oral corticosteroid (yes or no) and geographical region (US or other).|Reslizumab vs placebo|Kaplan-Meier estimate of probability (5) of not experiencing a CAE by week 52. The first CAEs for each patient occurring after randomization and up to 2 weeks after the end of treatment period were analyzed. Patients without a CAE within this time frame were censored at two weeks after the treatment completion date or study discontinuation, whichever came first.||0.750|0.440|<0.0001
72401225|NCT03265249|144309698|SUPERIORITY||Median Difference (Final Values)|5.7||||0.8|TWO_SIDED|95.0|-17.5|29.0|||Mixed Models Analysis|||||29|-17.5|0.80
72401226|NCT05954052|144309779|SUPERIORITY||Mean Difference (Final Values)|4.0|STANDARD_DEVIATION|9.0||0.1807|TWO_SIDED|95.0|-6.24|14.24|||Wilcoxon (Mann-Whitney)|||For the analysis of (ABC) scores at baseline and 12 weeks in this single-arm, open-label pilot study (n=6 participants, all with paired data including the early dropout), we use superiority test, This aligns with the study's hypothesis that oral glutathione supplementation would lead to an improvement (i.e., a decrease in ABC scores, indicating reduced irritability). Superiority testing evaluates whether the post-treatment mean (or median) is significantly lower than the baseline||14.24|-6.24|0.1807
72401227|NCT02584504|144309786|SUPERIORITY||Least Square (LS) Mean Difference|-39.5|||<|0.0001|TWO_SIDED|97.5|-46.5|-32.4||Threshold for significance at 0.025 level for Bonferroni adjustment.|Mixed Models Analysis|Threshold for significance at 0.025 level.|Alirocumab 150 mg Q4W vs. Placebo|Alirocumab 150 mg Q4W group was compared to placebo group using an appropriate contrast statement.||-32.4|-46.5|<0.0001
72401228|NCT02584504|144309786|SUPERIORITY||LS Mean Difference|-65.8|||<|0.0001|TWO_SIDED|97.5|-72.9|-58.7||Threshold for significance at 0.025 level for Bonferroni adjustment.|Mixed Models Analysis||Alirocumab 150 mg Q2W vs. Placebo|Alirocumab 150 mg Q2W group was compared to placebo group using an appropriate contrast statement.||-58.7|-72.9|<0.0001
72401229|NCT02584504|144309786|OTHER|Statistical test was not planned because this comparison was for a descriptive purpose.|LS Mean Difference|-26.3|||||TWO_SIDED|95.0|-32.5|-20.0|||||Alirocumab 150 mg Q4W group vs Alirocumab 150 mg Q2W|Alirocumab 150 mg Q4W group was compared to Alirocumab 150 mg Q2W group using an appropriate contrast statement.||-20.0|-32.5|
72401230|NCT02584504|144309787|SUPERIORITY||LS Mean Difference|-40.6|||<|0.0001|TWO_SIDED|97.5|-47.4|-33.8||Threshold for significance at 0.025 level for Bonferroni adjustment.|Mixed Models Analysis||Alirocumab 150 mg Q4W vs. Placebo|A hierarchical testing procedure was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when previous endpoint was statistically significant at 0.025 level. Hierarchical procedure for comparisons of Alirocumab 150 mg Q4W versus Placebo Q2W and Alirocumab 150 mg Q2W versus Placebo Q2W were processed separately.||-33.8|-47.4|<0.0001
72401231|NCT02584504|144309787|SUPERIORITY||LS Mean Difference|-67.4|||<|0.0001|TWO_SIDED|97.5|-74.2|-60.5||Threshold for significance at 0.025 level for Bonferroni adjustment.|Mixed Models Analysis||Alirocumab 150 mg Q2W vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the relevant compared arms).||-60.5|-74.2|<0.0001
72401232|NCT02584504|144309788|SUPERIORITY||LS Mean Difference|-50.5|||<|0.0001|TWO_SIDED|97.5|-56.6|-44.5||Threshold for significance at 0.025 level for Bonferroni adjustment.|Mixed Models Analysis||Alirocumab 150 mg Q4W vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the relevant compared arms).||-44.5|-56.6|<0.0001
72401233|NCT02584504|144309788|SUPERIORITY||LS Mean Difference|-66.2|||<|0.0001|TWO_SIDED|97.5|-72.3|-60.1||Threshold for significance at 0.025 level for Bonferroni adjustment.|Mixed Models Analysis||Alirocumab 150 mg Q2W vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the relevant compared arms).||-60.1|-72.3|<0.0001
72401234|NCT02584504|144309789|SUPERIORITY||LS Mean Difference|-51.4|||<|0.0001|TWO_SIDED|97.5|-57.4|-45.4||Threshold for significance at 0.025 level for Bonferroni adjustment.|Mixed Models Analysis||Alirocumab 150 mg Q4W vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the relevant compared arms).||-45.4|-57.4|<0.0001
72401235|NCT02584504|144309789|SUPERIORITY||LS Mean Difference|-67.3|||<|0.0001|TWO_SIDED|97.5|-73.3|-61.3||Threshold for significance at 0.025 level for Bonferroni adjustment.|Mixed Models Analysis||Alirocumab 150 mg Q2W vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the relevant compared arms).||-61.3|-73.3|<0.0001
72401236|NCT02584504|144309790|SUPERIORITY||LS Mean Difference|-26.2|||<|0.0001|TWO_SIDED|97.5|-32.5|-19.9||Threshold for significance at 0.025 level for Bonferroni adjustment.|Mixed Models Analysis||Alirocumab 150 mg Q4W vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the relevant compared arms).||-19.9|-32.5|<0.0001
72480681|NCT04281004|144487608|SUPERIORITY|||||||0.89||||||Significance of treatment effect at month 6.|Wilcoxon (Mann-Whitney)|Clustered version of the Wilcoxon test||||||0.890
72401237|NCT02584504|144309790|SUPERIORITY||LS Mean Difference|-51.9|||<|0.0001|TWO_SIDED|97.5|-58.3|-45.5||Threshold for significance at 0.025 level for Bonferroni adjustment.|Mixed Models Analysis||Alirocumab 150 mg Q2W vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the relevant compared arms).||-45.5|-58.3|<0.0001
72401238|NCT02584504|144309791|SUPERIORITY||LS Mean Difference|-27.2|||<|0.0001|TWO_SIDED|97.5|-33.5|-20.9||Threshold for significance at 0.025 level for Bonferroni adjustment.|Mixed Models Analysis||Alirocumab 150 mg Q4W vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the relevant compared arms).||-20.9|-33.5|<0.0001
72401239|NCT02584504|144309791|SUPERIORITY||LS Mean Difference|-53.4|||<|0.0001|TWO_SIDED|97.5|-59.7|-47.1||Threshold for significance at 0.025 level for Bonferroni adjustment.|Mixed Models Analysis||Alirocumab 150 mg Q2W vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the relevant compared arms).||-47.1|-59.7|<0.0001
72401240|NCT02584504|144309792|SUPERIORITY||LS Mean Difference|-31.3|||<|0.0001|TWO_SIDED|97.5|-37.7|-25.0||Threshold for significance at 0.025 level for Bonferroni adjustment.|Mixed Models Analysis||Alirocumab 150 mg Q4W vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the relevant compared arms).||-25.0|-37.7|<0.0001
72480682|NCT04281004|144487608|SUPERIORITY|||||||0.192||||||Significance of treatment effect at month 12.|Wilcoxon (Mann-Whitney)|Clustered version of the Wilcoxon test||||||0.192
72480683|NCT04281004|144487609|SUPERIORITY|||||||0.057||||||Significance of treatment effect at month 1.|Mixed Models Analysis|Mixed model analysis is used to account for correlation between eyes in the same participant.||||||0.057
72480684|NCT04281004|144487609|SUPERIORITY|||||||0.528||||||Significance of treatment effect at month 3.|Mixed Models Analysis|Mixed model analysis is used to account for correlation between eyes in the same participant.||||||0.528
72480685|NCT04281004|144487609|SUPERIORITY|||||||0.21||||||Significance of treatment effect at month 6.|Mixed Models Analysis|Mixed model analysis is used to account for correlation between eyes in the same participant.||||||0.210
72480686|NCT04281004|144487609|SUPERIORITY|||||||0.853||||||Significance of treatment effect at month 12.|Mixed Models Analysis|Mixed model analysis is used to account for correlation between eyes in the same participant.||||||0.853
72480687|NCT02482870|144487613|SUPERIORITY_OR_OTHER_LEGACY|||||||0.119|TWO_SIDED|||||A priori threshold for statistical significance was 0.05.|Chi-squared|Chi-square value = 2.424; degrees of freedom = 1||Sample size was calculated according to the first 60 patients. To obtain 90% power with an alpha error of 0.05, a total of 378 patients were required. Considering a possible drop-out rate of 2.5% due to unexpected complications, we aimed for 388 patients.||||0.119
72510066|NCT01721408|144550795|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was concluded if the lower limit of the 2-sided CI for the difference in eradication rates between treatment groups (tigecycline minus imipenem/cilastatin) was greater than -15%.|Difference in percentage|-7.3||||0.0277|TWO_SIDED|95.0|-15.2|0.5|||See method of CI||CIs and p-values for between-group treatment difference in eradication rates were calculated by the asymptotic method corrected for continuity with normal distribution approximation.|||0.5|-15.2|0.0277
72480688|NCT02482870|144487614|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.8|||<|0.0001|TWO_SIDED|95.0|3.0|4.6||A priori threshold for statistical significance was 0.05.|Wilcoxon (Mann-Whitney)|||||4.6|3|<0.0001
72480689|NCT02482870|144487615|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.9|||<|0.0001|TWO_SIDED|95.0|0.5|1.4||A priori threshold for statistical significance was 0.05.|Wilcoxon (Mann-Whitney)|||||1.4|0.5|<0.0001
72480690|NCT02482870|144487616|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.81|||<|0.0001|TWO_SIDED|95.0|-0.95|-0.67||A priori threshold for statistical significance was 0.05.|t-test, 2 sided|t value = -11.224, degrees of freedom = 773.99||"For each patient, the difference between Cormack-Lehane score and Mallampati class was calculated for each laryngoscope. As an example, the first patient had a Mallampati score 3. Macintosh laryngoscope provided a Cormack-Lehane score of 2, therefore the difference is - 1, calculated as 2 - 3. In the same patient, King Vision video laryngoscope provided a Cormack-Lehane score of 1, therefore the difference is - 2, calculated as 1 - 3. T-test was used to compare the differences."||-0.67|-0.95|<0.0001
72401241|NCT02584504|144309792|SUPERIORITY||LS Mean Difference|-56.2|||<|0.0001|TWO_SIDED|97.5|-62.5|-49.8||Threshold for significance at 0.025 level for Bonferroni adjustment.|Mixed Models Analysis||Alirocumab 150 mg Q2W vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the relevant compared arms).||-49.8|-62.5|<0.0001
72401242|NCT02584504|144309793|SUPERIORITY||LS Mean Difference|-32.4|||<|0.0001|TWO_SIDED|97.5|-38.6|-26.3||Threshold for significance at 0.025 level for Bonferroni adjustment.|Mixed Models Analysis||Alirocumab 150 mg Q4W vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the relevant compared arms).||-26.3|-38.6|<0.0001
72480691|NCT02482870|144487617|SUPERIORITY_OR_OTHER_LEGACY|||||||0.75|TWO_SIDED|||||A priori threshold for statistical significance was 0.05.|Chi-squared, Corrected|Chi-square test with Yates' continuity correction: chi-square = 0.101; degrees of freedom = 1||||||0.75
72480692|NCT03794908|144487627|SUPERIORITY||Mean Difference (Net)|3.8|STANDARD_ERROR_OF_MEAN|3.49||0.28|TWO_SIDED|95.0|-3.03|10.64|||Mixed Models Analysis|The comparison was done using a mixed model with assessments at 3 time points (pre-treatment, mid-treatment, and end of treatment).||Test of between-arm difference at mid-treatment.||10.64|-3.03|0.28
72480693|NCT03794908|144487627|SUPERIORITY||Mean Difference (Net)|4.48|STANDARD_ERROR_OF_MEAN|3.53||0.21|TWO_SIDED|95.0|-2.44|11.4|||Mixed Models Analysis|The comparison was done using a mixed model with assessments at 3 time points (pre-treatment, mid-treatment, and end of treatment).||Test of between-arm difference at end of treatment.||11.40|-2.44|0.21
72510067|NCT01721408|144550797|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was concluded if the lower limit of the 2-sided CI for the difference in cure rates between treatment groups (tigecycline minus imipenem/cilastatin) was greater than -15%.|Difference in percentage|-6.0||||0.004|TWO_SIDED|95.0|-12.8|0.8|||See method of CI||Used the asymptotic method corrected for continuity with normal distribution approximation. Non-inferiority test was conducted on the CE population. If non-inferiority was concluded, superiority test was conducted on both the CE and mITT populations.|||0.8|-12.8|0.0040
72480694|NCT01337115|144487647|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|28.44|STANDARD_ERROR_OF_MEAN|8.4||0.001|TWO_SIDED|95.0|11.55|45.34|||t-test, 2 sided|||Difference between mean VAS pain scores. Power 80%. Null hypothesis states there is no difference between pains scores in both groups||45.34|11.55|0.001
72480695|NCT01337115|144487648|SUPERIORITY_OR_OTHER|||||||0.537||||||The null hypothesis is that there is no difference in patient satisfaction distribution by the three categories used (Bad; Reasonable; Good/Very Good) between groups.|Fisher's exact test|Fisher's Exact test allows to test for the significance of the distribution in the results table with three categories.||||||0.537
72510068|NCT01064648|144550799|OTHER||Hazard Ratio (HR)|0.71||||0.06|TWO_SIDED|80.0|0.54|0.95||1-sided p-value|Log Rank|Stratified log rank test by performance status and histology type.||||0.95|0.54|0.06
72510069|NCT01064648|144550800|OTHER||Hazard Ratio (HR)|0.88||||0.28|TWO_SIDED|80.0|0.65|1.17||1-sided p-value|Log Rank|Stratified log-rank test by performance status and histology.||||1.17|0.65|0.28
72401243|NCT02584504|144309793|SUPERIORITY||LS Mean Difference|-57.6|||<|0.0001|TWO_SIDED|97.5|-63.8|-51.4||Threshold for significance at 0.025 level for Bonferroni adjustment.|Mixed Models Analysis||Alirocumab 150 mg Q2W vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the relevant compared arms).||-51.4|-63.8|<0.0001
72480696|NCT01337115|144487649|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|16.92|STANDARD_ERROR_OF_MEAN|5.67||0.006|TWO_SIDED|95.0|5.52|28.33|||t-test, 2 sided|||Null hypothesis states that there is no difference between groups. Power 80%||28.33|5.52|0.006
72480697|NCT01337115|144487650|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.55|STANDARD_ERROR_OF_MEAN|7.14||0.723|TWO_SIDED|95.0|-16.93|11.83|||t-test, 2 sided|||Null hypothesis states there is no difference between both groups. Power 80% to detect 15% difference in means||11.83|-16.93|0.723
72480698|NCT00406653|144487727|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.2||||0.611|TWO_SIDED|95.0|0.6|2.4||Due to randomization misspecification, 2:2:2:1 ratio applied instead of planned 2:1:2:2 (placebo, ABA 3mg/kg, \~10mg/kg, 30/\~10mg/kg). Only \~half intended number assigned to ABA 30/\~10 mg/kg arm and \~double intended number assigned to ABA 3 mg/kg arm|Cochran-Mantel-Haenszel|Second primary comparison (conditional on first): power=91%, sample size=134, 5% significance; expected PLA response rate= 25%, ABA/\~10 mg/kg=45%|All participants who prematurely discontinued for any reason considered not to have achieved clinical response. Normal approximation used if number of responses in treatment group was ≥5. Otherwise an exact method was used.|Conditional on abatacept (ABA) 30/\~10 mg/kg vs placebo (PLA)comparison being statistically significant at 5% significance level, ABA \~10 mg/kg vs PLA to be tested at 5% significance level. Null hypothesis=no treatment difference (relative risk \[RR\] of ABA over placebo=1).First comparison: power=99%,sample size=134,expected PLA response rate=25%, ABA 30/\~10 mg/kg=55%. Cochran-Mantel-Haenszel Chi square p-value and RR along with 95% confidence interval provided, adjusting for randomization strata||2.4|0.6|0.611
72480699|NCT00406653|144487730|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.18|||||TWO_SIDED|95.0|0.4|3.44||Due to randomization misspecification, 2:2:2:1 ratio applied instead of planned 2:1:2:2 (placebo, ABA mg/kg, \~10 mg/kg, 30/\~10 mg/kg). Only \~half intended number assigned to ABA 30/\~10 mg/kg arm and \~double intended number assigned to ABA 3 mg/kg arm|Cochran-Mantel-Haenszel|Second primary comparison (conditional on first): power=80%, sample size=134, 5% significance; expected PLA response rate= 15%, ABA/\~10 mg/kg=30%|All participants who prematurely discontinued for any reason considered not to have achieved clinical response. Normal approximation used if number of responses in treatment group was ≥5. Otherwise an exact method was used.|Conditional on abatacept (ABA) 30/\~10 mg/kg vs placebo (PLA)comparison being statistically significant at 5% significance level, ABA \~10 mg/kg vs PLA to be tested at 5% signficance level. Null hypothesis=no treatment difference (relative risk \[RR\] of ABA over placebo=1).First comparison: power=95%,sample size=134,expected PLA response rate=15%, ABA 30/\~10 mg/kg=35%. Cochran-Mantel-Haenszel Chi square p-value and RR along with 95% confidence interval provided, adjusting for randomization strata||3.44|0.4|
72510070|NCT01064648|144550801|OTHER||Odds Ratio (OR)|1.85||||0.15|TWO_SIDED|95.0|0.59|5.83||1-sided p-value|Chi-squared|Stratified Chi-square by performance status and histology.||||5.83|0.59|0.15
72510071|NCT01064648|144550802|OTHER||Odds Ratio (OR)|0.45||||0.09|TWO_SIDED|95.0|0.14|1.49||1-sided p-value|Chi-squared|Stratified Chi-Square by performance status and histology||||1.49|0.14|0.09
72510072|NCT01064648|144550803|OTHER||Odds Ratio (OR)|4.3||||0.006|TWO_SIDED|95.0|1.4|13.3||1-sided p-value|Chi-squared|Stratified Chi-Square by performance status and histology.||||13.3|1.4|0.006
72510073|NCT01064648|144550804|OTHER||Odds Ratio (OR)|0.59||||0.19|TWO_SIDED|95.0|0.18|1.94||1-sided p-value|Chi-squared|Stratified Chi-Square by performance status and histology||||1.94|0.18|0.19
72510074|NCT01286272|144550829|SUPERIORITY||Hazard Ratio (HR)|0.94||||0.8457|TWO_SIDED|95.0|0.51|1.74|||Log Rank|||||1.74|0.51|0.8457
72510075|NCT00074412|144550834|SUPERIORITY_OR_OTHER_LEGACY||6 month Rate of Cum. HIV Infection (%)|1.1|||||TWO_SIDED|95.0|0.3|1.8|||Kaplan-Meier Method|||||1.8|0.3|
72510076|NCT00074412|144550834|SUPERIORITY_OR_OTHER_LEGACY||6 month Rate of Cum. HIV Infection (%)|2.4|||||TWO_SIDED|95.0|1.3|3.6|||Kaplan-Meier Method|||||3.6|1.3|
72510077|NCT00074412|144550834|SUPERIORITY_OR_OTHER_LEGACY||Z statistic|1.973||||0.049||95.0||||P-value has not been adjusted for interim analysis or multiple testing. A priori threshold for statistical significance was 0.05.|Z-test|||Assuming the cumulative HIV infection rate in placebo group would be 4.2% (2.6 at 6 wk. \& 6.7 at 6 mon.), we estimated 1500 mother/infant pairs would provide 90% power to detect a reduction in HIV infection from 4.2% to 1.4% at 6 mon. with a Pearson χ² test statistic and a one-sided false positive error rate of 0.025. Rate of cumulative infection was calculated using Kaplan-Meier method and rates between extended NVP group and placebo were done with the Z statistic.||||0.049
72480700|NCT00406653|144487731|SUPERIORITY_OR_OTHER|||||||0.436||95.0||||All statistical testing was performed at a pre-specified alpha-level of 5%.|Cochran-Armitage Trend Test|||The Cochran-Armitage trend test was performed to evaluate whether a relationship existed between the response and dose regimen by comparing the proportion of participants in response across all four treatment arms. Normal approximation was used if the number of responses in a treatment group is at least 5. Otherwise an exact method was used.||||0.436
72401244|NCT02584504|144309794|SUPERIORITY||LS Mean Difference|-22.5|||<|0.0001|TWO_SIDED|97.5|-27.4|-17.6||Threshold for significance at 0.025 level for Bonferroni adjustment.|Mixed Models Analysis||Alirocumab 150 mg Q4W vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the relevant compared arms).||-17.6|-27.4|<0.0001
72401245|NCT02584504|144309794|SUPERIORITY||LS Mean Difference|-41.4|||<|0.0001|TWO_SIDED|97.5|-46.4|-36.5||Threshold for significance at 0.025 level for Bonferroni adjustment.|Mixed Models Analysis||Alirocumab 150 mg Q2W vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the relevant compared arms).||-36.5|-46.4|<0.0001
72401246|NCT02584504|144309795|SUPERIORITY||Odds Ratio (OR)|61.2|||<|0.0001|TWO_SIDED|97.5|13.9|268.9||Threshold for significance at 0.025 level for Bonferroni adjustment.|Regression, Logistic|Multiple imputation approach followed by logistic regression model.|Alirocumab 150 mg Q4W vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the relevant compared arms).||268.9|13.9|<0.0001
72480701|NCT00406653|144487738|SUPERIORITY_OR_OTHER|||||||0.112|TWO_SIDED|95.0||||All statistical testing was performed at a pre-specified alpha-level of 5%.|Cochran-Armitage Trend Test|||The Cochran-Armitage trend test was performed to evaluate whether a relationship existed between the response and dose regimen by comparing the proportion of participants in response across all four treatment arms. Normal approximation was used if the number of responses in a treatment group is at least 5. Otherwise an exact method was used.||||0.112
72480702|NCT03513588|144487759|OTHER||Least Squares Mean Difference|-24.34|||<|0.001|TWO_SIDED|80.0|-31.28|-16.7|||ANCOVA|||||-16.70|-31.28|<0.001
72480703|NCT03513588|144487759|OTHER||Least Squares Mean Difference|-33.91|||<|0.001|TWO_SIDED|80.0|-39.78|-27.47|||ANCOVA|||||-27.47|-39.78|<0.001
72510078|NCT00074412|144550836|SUPERIORITY_OR_OTHER_LEGACY||Cum. Rate of HIV-free Survival 6mon (%)|97.7|||||TWO_SIDED|95.0|96.6|98.8|||Kaplan-Meier Method|||The cumulative rate of HIV-free survival at 6 months in the extended NVP arm was calculated using the Kaplan-Meier method; while the 95% CI was calculated using Greenwood's formula.||98.8|96.6|
72510079|NCT00074412|144550836|SUPERIORITY_OR_OTHER_LEGACY||Cum. Rate of HIV-free Survival 6mon (%)|96.8|||||TWO_SIDED|95.0|95.5|98.0|||Kaplan-Meier Method|||The cumulative rate of HIV-free survival at 6 months in the placebo arm was calculated using the Kaplan-Meier method; while the 95% CI was calculated using Greenwood's formula.||98.0|95.5|
72510080|NCT00074412|144550836|SUPERIORITY_OR_OTHER_LEGACY||Z statistic|1.095||||0.274||95.0||||P-value was not adjusted for interim analysis or multiple testing.|Z-test|||The cumulative rates of HIV-free survival at 6 months were compared between the two groups using a Z-statistic.||||0.274
72510081|NCT00074412|144550836|SUPERIORITY_OR_OTHER_LEGACY||Cum. Rate of HIV-free Survival 18mon (%)|94.5|||||TWO_SIDED|95.0|92.9|96.2|||Kaplan-Meier Method|||The cumulative rate of HIV-free survival at 18 months in the extended NVP arm was calculated using the Kaplan-Meier method; while 95% confidence intervals were calculated using Greenwood's formula.||96.2|92.9|
72480704|NCT01054846|144487840|SUPERIORITY_OR_OTHER||z value|2.696|||<|0.01|TWO_SIDED||||||Chi-squared|||Differences between Survey 1 and Survey 2||||<0.01
72480705|NCT01054846|144487840|SUPERIORITY_OR_OTHER||z value|1.351|||>|0.05|TWO_SIDED||||||Chi-squared|||Difference between Survey 1 and Survey 2||||>0.05
72480706|NCT02446886|144487842|SUPERIORITY||Mean Difference (Final Values)|1.65||||0.04|TWO_SIDED||||||t-test, 2 sided|||Previously published reproducibility of our MWF imaging (FAST-T2) has been established to be +/- 2.0 Our hypothesis for this study was the monthly ACTH would lead to greater remylination in acute MS lesions. However, to reach this goal, improvement must be beyond established reproducibility. Note: Since MWF is a fraction of myelin water to total water, it does not have a unit.||||0.04
72480707|NCT02446886|144487847|SUPERIORITY||Mean Difference (Final Values)|1.65||||0.077|TWO_SIDED||||||Mixed Models Analysis|||Linear mixed-effects models were implemented to assess the variables of interest (lesion MWF) among patients randomized to once versus the monthly ACTH treatment group. The modeling strategy accounts for multiple lesions per patient, repeated measurements (longitudinal analysis) and the following covariates were always considered: patient age, gender, disease duration, individual T2w lesion volume, time on disease modifying treatments (DMT) prior to enrollment, and DMT during the study.|Linear mixed-effects models were implemented|||0.077
72480708|NCT02988622|144487873|SUPERIORITY||Mean Difference (Net)|0.1205|STANDARD_DEVIATION|0.5499||0.0492|TWO_SIDED||||||t-test, 2 sided|||||||0.0492
72480709|NCT02988622|144487874|SUPERIORITY||Mean Difference (Net)|0.241|STANDARD_DEVIATION|0.0817||0.0817|TWO_SIDED||||||t-test, 2 sided|||||||0.0817
72510082|NCT00074412|144550836|SUPERIORITY_OR_OTHER_LEGACY||Cum. Rate of HIV-free Survival 18mon (%)|93.3|||||TWO_SIDED|95.0|91.5|95.1|||Kaplan-Meier Method|||The cumulative rate of HIV-free survival at 18 months in the placebo arm was calculated using the Kaplan-Meier method; while the 95% confidence interval was calculated using Greenwood's formula.||95.1|91.5|
72510083|NCT00074412|144550836|SUPERIORITY_OR_OTHER_LEGACY||Z statistic|0.988||||0.323||95.0||||P-value was not adjusted for interim analysis or multiple testing.|Z-test|||The cumulative rates of HIV-free survival at 18 months were compared between the two groups using a Z statistic.||||0.323
72510084|NCT00074412|144550837|SUPERIORITY_OR_OTHER_LEGACY||18 mon. Rate of Cum HIV Infection (%)|2.2|||||TWO_SIDED|95.0|1.1|3.3|||Kaplan-Meier Method|||The cumulative rate of HIV infection at 18 months in the extended NVP arm was calculated using the Kaplan-Meier method; while the 95% confidence interval was calculated using Greenwood's formula.||3.3|1.1|
72510085|NCT00074412|144550837|SUPERIORITY_OR_OTHER_LEGACY||18 mon. Rate of Cum. HIV Infection (%)|3.1|||||TWO_SIDED|95.0|1.9|4.4|||Kaplan-Meier Method|||The cumulative rate of HIV infection at 18 months in the placebo arm was calculated using the Kaplan-Meier method; while the 95% confidence interval was calculated using Greenwood's formula.||4.4|1.9|
72510086|NCT00074412|144550837|SUPERIORITY_OR_OTHER_LEGACY||Z statistic|1.081||||0.28||95.0||||P-value was not adjusted for interim analysis or multiple testing.|Z-test|||The cumulative rates of HIV infection at 18 months were calculated using the Kaplan-Meier method and were compared between arms using a Z statistic.||||0.280
72401247|NCT02584504|144309795|SUPERIORITY||Odds Ratio (OR)|281.4|||<|0.0001|TWO_SIDED|97.5|33.3|2382.2||Threshold for significance at 0.025 level for Bonferroni adjustment.|Regression, Logistic|Multiple imputation approach followed by logistic regression model.|Alirocumab 150 mg Q2W vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the relevant compared arms).||2382.2|33.3|<0.0001
72401248|NCT02584504|144309796|SUPERIORITY||Odds Ratio (OR)|102.8|||<|0.0001|TWO_SIDED|97.5|19.0|556.8||Threshold for significance at 0.025 level for Bonferroni adjustment.|Regression, Logistic|Multiple imputation approach followed by logistic regression model.|Alirocumab 150 mg Q4W vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the relevant compared arms).||556.8|19.0|<0.0001
72401249|NCT02584504|144309796|SUPERIORITY||Odds Ratio (OR)|500.8|||<|0.0001|TWO_SIDED|97.5|47.9|5230.9||Threshold for significance at 0.025 level for Bonferroni adjustment.|Regression, Logistic|Multiple imputation approach followed by logistic regression model.|Alirocumab 150 mg Q2W vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the relevant compared arms).||5230.9|47.9|<0.0001
72480710|NCT02988622|144487875|SUPERIORITY||Mean Difference (Net)|0.3659|STANDARD_DEVIATION|1.7951||0.0686|TWO_SIDED||||||t-test, 2 sided|||||||0.0686
72480711|NCT02988622|144487876|SUPERIORITY||Mean Difference (Net)|-0.0843|STANDARD_DEVIATION|1.5789||0.6278|TWO_SIDED||||||t-test, 2 sided|||||||0.6278
72480712|NCT02988622|144487877|SUPERIORITY||Mean Difference (Net)|0.3373|STANDARD_DEVIATION|1.7619||0.0848|TWO_SIDED||||||t-test, 2 sided|||||||0.0848
72480713|NCT02988622|144487878|SUPERIORITY||Mean Difference (Net)|0.2195|STANDARD_DEVIATION|2.0788||0.3418|TWO_SIDED||||||t-test, 2 sided|||||||0.3418
72510087|NCT00074412|144550838|SUPERIORITY_OR_OTHER_LEGACY||Cumulative Mortality Rate at 18mon (%)|4.7|||||TWO_SIDED|95.0|2.0|7.4|||Kaplan-Meier Method|||||7.4|2.0|
72566748|NCT01287039|144664230|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|0.058|STANDARD_ERROR_OF_MEAN|0.0125|<|0.0001|TWO_SIDED|95.0|0.034|0.083|||Mixed model repeated measures|||For each week, inferential statistics were from mixed model repeated measures (MMRM) with treatment, visit, treatment by visit interaction, region, oral glucocorticosteroids use at enrollment as fixed factor, and covariate baseline value and patient as a random effect. Unstructured covariance structure was assumed for the repeated measures.||0.083|0.034|<0.0001
72566749|NCT01287039|144664231|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.276|STANDARD_ERROR_OF_MEAN|0.1632||0.0919|TWO_SIDED|95.0|-0.597|0.045|||Mixed model repeated measures|||Inferential statistics were from mixed model repeated measures (MMRM) with treatment, visit, treatment by visit interaction, region, OCS use at enrollment as fixed factors, and covariate for baseline value and patient as a random effect. Unstructured covariance structure was assumed for the repeated measures.||0.045|-0.597|0.0919
72401250|NCT02584504|144309797|SUPERIORITY||Adjusted Mean Difference|-32.9|||<|0.0001|TWO_SIDED|97.5|-43.4|-22.5||Threshold for significance at 0.025 level for Bonferroni adjustment.|Regression, Robust|Multiple imputation approach followed by robust regression model.|Alirocumab 150 mg Q4W vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the relevant compared arms).||-22.5|-43.4|<0.0001
72480714|NCT02988622|144487879|SUPERIORITY||Mean Difference (Net)|0.2375|STANDARD_DEVIATION|1.5528||0.1752|TWO_SIDED||||||t-test, 2 sided|||||||0.1752
72480715|NCT02988622|144487881|SUPERIORITY||Mean Difference (Net)|0.3824|STANDARD_DEVIATION|1.5685||0.0281|TWO_SIDED||||||t-test, 2 sided|||||||0.0281
72480716|NCT00178126|144487882|SUPERIORITY_OR_OTHER|||||||0.04|||||||Fisher Exact|||||||0.04
72480717|NCT06020118|144487883|SUPERIORITY|95% exact Clopper-Pearson confidence boundaries and the p-values were calculated using a logistic regression model adjusted for site.||||||0.938|TWO_SIDED|95.0||||Number of participants achieving HAI seroconversion (a titer ≥1:40 following ccIIV4 if the baseline titer is \<1:10 or a four-fold rise in titer if the baseline titer is \>1:10) following ccIIV4 vaccination for each 2023-24 influenza vaccine antigen.|Regression, Logistic|||Antigen: A(H1N1)pdm09||||0.938
72480718|NCT06020118|144487883|SUPERIORITY|95% exact Clopper-Pearson confidence boundaries and the p-values were calculated using a logistic regression model adjusted for site.||||||0.451||||||Number of participants achieving HAI seroconversion (a titer ≥1:40 following ccIIV4 if the baseline titer is \<1:10 or a four-fold rise in titer if the baseline titer is \>1:10) following ccIIV4 vaccination for each 2023-24 influenza vaccine antigen.|Regression, Logistic|||Antigen: A(H3N2)||||0.451
72480719|NCT06020118|144487883|SUPERIORITY|95% exact Clopper-Pearson confidence boundaries and the p-values were calculated using a logistic regression model adjusted for site.||||||0.819||||||Number of participants achieving HAI seroconversion (a titer ≥1:40 following ccIIV4 if the baseline titer is \<1:10 or a four-fold rise in titer if the baseline titer is \>1:10) following ccIIV4 vaccination for each 2023-24 influenza vaccine antigen.|Regression, Logistic|||Antigen: B/Victoria||||0.819
72510088|NCT00074412|144550838|SUPERIORITY_OR_OTHER_LEGACY||Cumulative Mortality Rate at 18mon (%)|4.1|||||TWO_SIDED|95.0|2.7|5.6|||Kaplan-Meier Method|||||5.6|2.7|
72510089|NCT00074412|144550838|SUPERIORITY_OR_OTHER_LEGACY||Z statistic|-0.247||||0.805||95.0||||P-value was not adjusted for interim analysis or multiple testing|Z-test|||The cumulative rates of mortality at 6 months, as calculated by Kaplan-Meier, were compared between the two groups using a Z-statistic.||||0.805
72510090|NCT00074412|144550838|SUPERIORITY_OR_OTHER_LEGACY||Cumulative Mortality Rate at 6mon (%)|1.2|||||TWO_SIDED|95.0|0.4|2.0|||Kaplan-Meier Method|||||2.0|0.4|
72510091|NCT00074412|144550838|SUPERIORITY_OR_OTHER_LEGACY||Cumulative Mortality Rate at 6mon (%)|1.1|||||TWO_SIDED|95.0|0.3|1.8|||Kaplan-Meier Method|||||1.8|0.3|
72510092|NCT00074412|144550838|SUPERIORITY_OR_OTHER_LEGACY||Z statistic|-0.36||||0.719||95.0||||P-value was not adjusted for interim analysis or multiple testing.|Z-test|||The cumulative mortality rates at 18 months, as calculated by Kaplan-Meier, were compared between the two groups using a Z statistic.||||0.719
72401251|NCT02584504|144309797|SUPERIORITY||Adjusted Mean Difference|-50.9|||<|0.0001|TWO_SIDED|97.5|-61.5|-40.3||Threshold for significance at 0.025 level for Bonferroni adjustment.|Regression, Robust|Multiple imputation approach followed by robust regression model.|Alirocumab 150 mg Q2W vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the relevant compared arms).||-40.3|-61.5|<0.0001
72401252|NCT02584504|144309798|SUPERIORITY||LS Mean Difference|5.7||||0.0241|TWO_SIDED|97.5|0.0|11.3||Threshold for significance at 0.025 level for Bonferroni adjustment.|Mixed Models Analysis||Alirocumab 150 mg Q4W vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the relevant compared arms).||11.3|0.0|0.0241
72401253|NCT02584504|144309798|SUPERIORITY||LS Mean Difference|7.8||||0.0022|TWO_SIDED|97.5|2.1|13.5||Threshold for significance at 0.025 level for Bonferroni adjustment.|Mixed Models Analysis||Alirocumab 150 mg Q2W vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the relevant compared arms).||13.5|2.1|0.0022
72401254|NCT02584504|144309799|SUPERIORITY||Adjusted Mean Difference|5.9||||0.2645|TWO_SIDED|97.5|-5.9|17.7||Threshold for significance at 0.025 level for Bonferroni adjustment.|Regression, Robust|Multiple imputation approach followed by robust regression model.|Alirocumab 150 mg Q4W vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the relevant compared arms).||17.7|-5.9|0.2645
72401255|NCT02584504|144309799|SUPERIORITY||Adjusted Mean Difference|-11.6||||0.0299|TWO_SIDED|97.5|-23.5|0.4||Threshold for significance at 0.025 level for Bonferroni adjustment.|Regression, Robust||Alirocumab 150 mg Q2W vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the relevant compared arms).||0.4|-23.5|0.0299
72401256|NCT02066467|144309828|OTHER||||||<|0.0001|||||||exact binominal methodology|||||||<0.0001
72401257|NCT02066467|144309830|OTHER||||||<|0.0001|||||||exact binominal methodology|||||||<0.0001
72401258|NCT02596854|144309847|NON_INFERIORITY|α=0.025 with a margin of Δ=0.5 were used for non-inferiority testing|Median Difference (Net)|-0.428|STANDARD_ERROR_OF_MEAN|0.3522|<|0.001|TWO_SIDED|95.0|-0.428|-0.269||No adjustments were made for multiple comparisons.|Wilcoxon (Mann-Whitney)||Notably, no separate comparative statistical analysis was performed for the 1.5T and 3.0T subgroups, which were pooled for analysis. All patients underwent both synthetic MR and commercial conventional MR in a single arm.|Non-inferiority of synthetic MR versus conventional commercial MR the hypothesis can be stated as H0: S ≤ -Δ and HA: S \> -Δ.|To mitigate possible bias, the hypothesis test was executed via pre-programmed SAS module, which does not show the data for individual synthetic and conventional group values. The data for these individual groups is thus not currently available as part of the study report held by the sponsor or submitted to FDA. Thus, this data cannot be presented without additional analysis (re-programming) of the original SAS used to perform the study. Data were only reported as the difference between synthetic - conventional to determine non-inferiority, and data for individual crossovers (synthetic vs. conventional) were not calculated.The raw conventional scan images and those post-processed with the research software were combined as pre-specified in the study protocol|-0.269|-0.428|<0.001
72401259|NCT00362115|144309999|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.9||||0.0631|TWO_SIDED|95.0|-5.96|0.16||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||0.16|-5.96|0.0631
72401260|NCT00362115|144309999|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.3||||0.0008|TWO_SIDED|95.0|-8.33|-2.2||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-2.20|-8.33|0.0008
72401261|NCT00362115|144309999|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.7||||0.0188|TWO_SIDED|95.0|-6.73|-0.61||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-0.61|-6.73|0.0188
72401262|NCT00362115|144309999|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.7||||0.0003|TWO_SIDED|95.0|-8.8|-2.63||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-2.63|-8.80|0.0003
72401263|NCT00362115|144309999|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.7||||0.0177|TWO_SIDED|95.0|-6.77|-0.65||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-0.65|-6.77|0.0177
72510093|NCT00074412|144550838|SUPERIORITY_OR_OTHER_LEGACY|||||||0.611||95.0|||||Log Rank|||We compared the cumulative mortality rates, as calculated using Kaplan-Meier, between the two study groups over all 18 months of the study follow-up using a log-rank test.||||0.611
72510094|NCT02891798|144550839|SUPERIORITY|||||||0.003|||||||t-test, 2 sided|||Comparison of SF-MPQ2 Total Score Difference From Baseline between the 4-drug nerve block group and the bupivacaine only group||||0.003
72510095|NCT02891798|144550840|SUPERIORITY|||||||0.001|||||||t-test, 2 sided|||Comparison of SF-MPQ2 Continuous Pain Subscore Difference From Baseline between the 4-drug nerve block group and the bupivacaine only group||||0.001
72510096|NCT02891798|144550841|SUPERIORITY|||||||0.038|||||||t-test, 2 sided|||Comparison of SF-MPQ2 Intermittent Pain Subscore Difference From Baseline between the 4-drug nerve block group and the bupivacaine only group||||0.038
72510097|NCT02891798|144550842|SUPERIORITY|||||||0.009|||||||t-test, 2 sided|||Comparison of QoR-15 Total Score at post-operative day 1 between the 4-drug nerve block group and the bupivacaine only group||||0.009
72510098|NCT02891798|144550843|NON_INFERIORITY|Testing the null hypothesis that Bupivacaine + BCD (buprenorphine, clonidine, dexamethasone) does not adversely affect recovery by producing a significantly lower score for the QoR-15 Total Score.||||||0.861|||||||t-test, 2 sided|||Comparison of QoR-15 Total Score at 6 week post-procedure between the 4-drug nerve block group and the bupivacaine only group||||0.861
72401264|NCT00362115|144309999|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3||||0.855||95.0|-2.72|3.27||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||3.27|-2.72|0.8550
72401265|NCT00362115|144309999|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.1||||0.1719|TWO_SIDED|95.0|-5.08|0.91||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||0.91|-5.08|0.1719
72401266|NCT00362115|144309999|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5||||0.7469|TWO_SIDED|95.0|-3.49|2.5||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||2.50|-3.49|0.7469
72401267|NCT00362115|144309999|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.5||||0.1001|TWO_SIDED|95.0|-5.55|0.49||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||0.49|-5.55|0.1001
72401268|NCT00362115|144309999|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5||||0.7294|TWO_SIDED|95.0|-3.52|2.47||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||2.47|-3.52|0.7294
72401269|NCT00362115|144310000|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.1||||0.0111|TWO_SIDED|95.0|-10.84|-1.41||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-1.41|-10.84|0.0111
72401270|NCT00362115|144310000|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.8|||<|0.0001|TWO_SIDED|95.0|-15.51|-6.08||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-6.08|-15.51|< 0.0001
72401271|NCT00362115|144310000|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.8|||<|0.0001|TWO_SIDED|95.0|-14.53|-5.1||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-5.10|-14.53|< 0.0001
72401272|NCT00362115|144310000|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.3|||<|0.0001|TWO_SIDED|95.0|-17.02|-7.52||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-7.52|-17.02|< 0.0001
72401273|NCT00362115|144310000|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.5||||0.0005|TWO_SIDED|95.0|-13.19|-3.76||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-3.76|-13.19|0.0005
72401274|NCT00362115|144310000|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.6||||0.2768|TWO_SIDED|95.0|-2.06|7.17||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||7.17|-2.06|0.2768
72401275|NCT00362115|144310000|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.1||||0.3688|TWO_SIDED|95.0|-6.74|2.51||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||2.51|-6.74|0.3688
72401276|NCT00362115|144310000|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-1.1||||0.6293|TWO_SIDED|95.0|-5.75|3.48||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||3.48|-5.75|0.6293
72401277|NCT00362115|144310000|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.6||||0.1298|TWO_SIDED|95.0|-8.25|1.06||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||1.06|-8.25|0.1298
72401278|NCT00362115|144310000|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2||||0.9315|TWO_SIDED|95.0|-4.41|4.82||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||4.82|-4.41|0.9315
72401279|NCT00362115|144310001|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.1||||0.0016|TWO_SIDED|95.0|-13.17|-3.09||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-3.09|-13.17|0.0016
72401280|NCT00362115|144310001|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.1|||<|0.0001|TWO_SIDED|95.0|-15.17|-5.09||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-5.09|-15.17|< 0.0001
72401281|NCT00362115|144310001|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.8|||<|0.0001|TWO_SIDED|95.0|-17.8|-7.72||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-7.72|-17.80|< 0.0001
72401282|NCT00362115|144310001|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.3|||<|0.0001|TWO_SIDED|95.0|-16.36|-6.2||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-6.20|-16.36|< 0.0001
72401283|NCT00362115|144310001|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.7|||<|0.0001|TWO_SIDED|95.0|-15.75|-5.63||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-5.63|-15.75|< 0.0001
72401284|NCT00362115|144310001|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.9909|TWO_SIDED|95.0|-4.96|4.91||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||4.91|-4.96|0.9909
72401285|NCT00362115|144310001|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.0||||0.4213|TWO_SIDED|95.0|-6.96|2.92||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||2.92|-6.96|0.4213
72401286|NCT00362115|144310001|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.7||||0.0646|TWO_SIDED|95.0|-9.59|0.28||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||0.28|-9.59|0.0646
72401287|NCT00362115|144310001|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.2||||0.2107|TWO_SIDED|95.0|-8.15|1.8||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||1.80|-8.15|0.2107
72401288|NCT00362115|144310001|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.6||||0.3059|TWO_SIDED|95.0|-7.54|2.37||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||2.37|-7.54|0.3059
72401289|NCT00362115|144310002|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.4||||0.1653|TWO_SIDED|95.0|-5.69|0.98||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||0.98|-5.69|0.1653
72480720|NCT06020118|144487883|SUPERIORITY|95% exact Clopper-Pearson confidence boundaries and the p-values were calculated using a logistic regression model adjusted for site.||||||0.5||||||Number of participants achieving HAI seroconversion (a titer ≥1:40 following ccIIV4 if the baseline titer is \<1:10 or a four-fold rise in titer if the baseline titer is \>1:10) following ccIIV4 vaccination for each 2023-24 influenza vaccine antigen.|Regression, Logistic|||Antigen: B/Yamagata||||0.500
72480721|NCT06020118|144487883|SUPERIORITY|95% exact Clopper-Pearson confidence boundaries and the p-values were calculated using a logistic regression model adjusted for site.|||||<|0.001||||||Number of participants achieving HAI seroconversion (a titer ≥1:40 following ccIIV4 if the baseline titer is \<1:10 or a four-fold rise in titer if the baseline titer is \>1:10) following ccIIV4 vaccination for each 2023-24 influenza vaccine antigen.|Regression, Logistic|||Antigen: A(H1N1)pdm09||||<.001
72480722|NCT06020118|144487883|SUPERIORITY|95% exact Clopper-Pearson confidence boundaries and the p-values were calculated using a logistic regression model adjusted for site.||||||0.001||||||Number of participants achieving HAI seroconversion (a titer ≥1:40 following ccIIV4 if the baseline titer is \<1:10 or a four-fold rise in titer if the baseline titer is \>1:10) following ccIIV4 vaccination for each 2023-24 influenza vaccine antigen.|Regression, Logistic|||Antigen: A(H3N2)||||0.001
72480723|NCT06020118|144487883|SUPERIORITY|95% exact Clopper-Pearson confidence boundaries and the p-values were calculated using a logistic regression model adjusted for site.|||||<|0.001||||||Number of participants achieving HAI seroconversion (a titer ≥1:40 following ccIIV4 if the baseline titer is \<1:10 or a four-fold rise in titer if the baseline titer is \>1:10) following ccIIV4 vaccination for each 2023-24 influenza vaccine antigen.|Regression, Logistic|||Antigen: B/Victoria||||<0.001
72480724|NCT06020118|144487883|SUPERIORITY|95% exact Clopper-Pearson confidence boundaries and the p-values were calculated using a logistic regression model adjusted for site.|||||<|0.001||||||Number of participants achieving HAI seroconversion (a titer ≥1:40 following ccIIV4 if the baseline titer is \<1:10 or a four-fold rise in titer if the baseline titer is \>1:10) following ccIIV4 vaccination for each 2023-24 influenza vaccine antigen.|Regression, Logistic|||Antigen: B/Yamagata||||<0.001
72480725|NCT06020118|144487884|SUPERIORITY|95% exact Clopper-Pearson confidence boundaries and the p-values were calculated using a logistic regression model adjusted for site.||||||0.894||||||Number of participants in each vaccination group with a seroprotective HAI (in a subset of samples) titer (≥1:40) pre- and post-ccIIV4 immunization for each 2023-24 influenza vaccine antigen.|Regression, Logistic|||Antigen: A(H1N1)pdm09||||0.894
72510099|NCT02891798|144550844|NON_INFERIORITY|Testing the null hypothesis that Bupivacaine + BCD (buprenorphine, clonidine, dexamethasone) does not adversely affect recovery by producing a significantly lower score for the Standing Balance test.||||||0.512|||||||t-test, 2 sided|||Comparison of Standing Balance Test score at 6 week post-procedure between the 4-drug nerve block group and the bupivacaine only group||||0.512
72510100|NCT02891798|144550845|NON_INFERIORITY|Testing the null hypothesis that Bupivacaine + BCD (buprenorphine, clonidine, dexamethasone) does not adversely affect recovery by producing a significantly slower rate for the Self-Selected Gait Speed test.||||||0.339|||||||t-test, 2 sided|||Comparison of Self-Selected Gait Speed rate at 6 week post-procedure between the 4-drug nerve block group and the bupivacaine only group.||||0.339
72401290|NCT00362115|144310002|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.2||||0.0151|TWO_SIDED|95.0|-7.5|-0.81||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-0.81|-7.50|0.0151
72480726|NCT06020118|144487884|SUPERIORITY|95% exact Clopper-Pearson confidence boundaries and the p-values were calculated using a logistic regression model adjusted for site.||||||0.104||||||Number of participants in each vaccination group with a seroprotective HAI (in a subset of samples) titer (≥1:40) pre- and post-ccIIV4 immunization for each 2023-24 influenza vaccine antigen.|Regression, Logistic|||Antigen: A(H3N2)||||0.104
72480727|NCT06020118|144487884|SUPERIORITY|95% exact Clopper-Pearson confidence boundaries and the p-values were calculated using a logistic regression model adjusted for site.||||||0.815||||||Number of participants in each vaccination group with a seroprotective HAI (in a subset of samples) titer (≥1:40) pre- and post-ccIIV4 immunization for each 2023-24 influenza vaccine antigen.|Regression, Logistic|||Antigen: B/Victoria||||0.815
72480728|NCT06020118|144487884|SUPERIORITY|95% exact Clopper-Pearson confidence boundaries and the p-values were calculated using a logistic regression model adjusted for site.||||||0.814||||||Number of participants in each vaccination group with a seroprotective HAI (in a subset of samples) titer (≥1:40) pre- and post-ccIIV4 immunization for each 2023-24 influenza vaccine antigen.|Regression, Logistic|||Antigen: B/Yamagata||||0.814
72510101|NCT02891798|144550846|NON_INFERIORITY|Testing the null hypothesis that Bupivacaine + BCD (buprenorphine, clonidine, dexamethasone) does not adversely affect recovery by producing a significantly slower time for the Repeated Chair Stand test.||||||0.711|||||||t-test, 2 sided|||Comparison of Repeated Chair Stand time at 6 week post-procedure between the 4-drug nerve block group and the bupivacaine only group.||||0.711
72510102|NCT00418834|144550855|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-13.8|STANDARD_ERROR_OF_MEAN|1.1|<|0.001||95.0|-16.0|-11.7|||ANCOVA|Model terms: treatment, baseline LDL-C, and AVD status|(Atorva 10 mg + EZ minus Atorva 20 mg)|||-11.7|-16.0|<0.001
72510103|NCT00418834|144550856|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.6|STANDARD_ERROR_OF_MEAN|1.4|<|0.001||95.0|-7.4|-1.8|||ANCOVA|Model terms: treatment, baseline LDL-C, and AVD status|(Atorva 10 mg + EZ minus Atorva 20 mg)|||-1.8|-7.4|<0.001
72401291|NCT00362115|144310002|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.4||||0.048|TWO_SIDED|95.0|-6.7|-0.03||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-0.03|-6.70|0.0480
72510104|NCT00418834|144550857|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|6.32|||<|0.001||95.0|4.52|8.84|||Regression, Logistic|Model terms: treatment, baseline LDL-C, and AVD status|Estimated ratio is the predictive odds of attaining LDL-C target on Atorva 10 mg + EZ versus Atorva 20 mg|||8.84|4.52|<0.001
72401292|NCT00362115|144310002|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.4||||0.0098|TWO_SIDED|95.0|-7.81|-1.08||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-1.08|-7.81|0.0098
72480729|NCT06020118|144487884|SUPERIORITY|95% exact Clopper-Pearson confidence boundaries and the p-values were calculated using a logistic regression model adjusted for site.|||||<|0.001||||||Number of participants in each vaccination group with a seroprotective HAI (in a subset of samples) titer (≥1:40) pre- and post-ccIIV4 immunization for each 2023-24 influenza vaccine antigen.|Regression, Logistic|||Antigen: A(H1N1)pdm09||||<0.001
72480730|NCT06020118|144487884|SUPERIORITY|95% exact Clopper-Pearson confidence boundaries and the p-values were calculated using a logistic regression model adjusted for site.|||||<|0.001||||||Number of participants in each vaccination group with a seroprotective HAI (in a subset of samples) titer (≥1:40) pre- and post-ccIIV4 immunization for each 2023-24 influenza vaccine antigen.|Regression, Logistic|||Antigen: A(H3N2)||||<0.001
72480731|NCT06020118|144487884|SUPERIORITY|95% exact Clopper-Pearson confidence boundaries and the p-values were calculated using a logistic regression model adjusted for site.|||||<|0.001||||||Number of participants in each vaccination group with a seroprotective HAI (in a subset of samples) titer (≥1:40) pre- and post-ccIIV4 immunization for each 2023-24 influenza vaccine antigen.|Regression, Logistic|||Antigen: B/Victoria||||<0.001
72480732|NCT06020118|144487884|SUPERIORITY|95% exact Clopper-Pearson confidence boundaries and the p-values were calculated using a logistic regression model adjusted for site.|||||<|0.001||||||Number of participants in each vaccination group with a seroprotective HAI (in a subset of samples) titer (≥1:40) pre- and post-ccIIV4 immunization for each 2023-24 influenza vaccine antigen.|Regression, Logistic|||Antigen: B/Yamagata||||<0.001
72480733|NCT06020118|144487885|SUPERIORITY|95% confidence intervals were calculated using a t-distribution on log2-transformed titers and p-values were calculated using a linear regression model adjusted for site.||||||0.699||||||GMTs and 95% confidence intervals were calculated using a t-distribution on log2-transformed titers.|Regression, Linear|||Pre-vaccine: Antigen A(H1N1)pdm09||||0.699
72480734|NCT06020118|144487885|SUPERIORITY|95% confidence intervals were calculated using a t-distribution on log2-transformed titers and p-values were calculated using a linear regression model adjusted for site.||||||0.88||||||GMTs and 95% confidence intervals were calculated using a t-distribution on log2-transformed titers.|Regression, Linear|||Post-vaccine: Antigen A(H1N1)pdm09||||0.880
72510105|NCT00418834|144550858|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.87|||<|0.001||95.0|1.4|2.5|||Regression, Logistic|Model terms: treatment, baseline LDL-C, and AVD status|Estimated ratio is the predictive odds of attaining LDL-C target on Atorva 10 mg + EZ versus Atorva 20 mg / Atorva 40 mg|||2.50|1.40|<0.001
72480735|NCT06020118|144487885|SUPERIORITY|95% confidence intervals were calculated using a t-distribution on log2-transformed titers and p-values were calculated using a linear regression model adjusted for site.||||||0.72||||||GMTs and 95% confidence intervals were calculated using a t-distribution on log2-transformed titers.|Regression, Linear|||Pre-vaccine: Antigen A(H3N2)||||0.720
72510106|NCT00418834|144550859|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|5.48|||<|0.001||95.0|3.98|7.55|||Regression, Logistic|Model terms: treatment, baseline LDL-C, and AVD status|Estimated ratio is the predictive odds of attaining LDL-C target on Atorva 10 mg + EZ versus Atorva 20 mg|||7.55|3.98|<0.001
72566750|NCT01287039|144664232|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.466|STANDARD_ERROR_OF_MEAN|0.0244|<|0.0001|TWO_SIDED|95.0|-0.514|-0.418|||Mixed model repeated measures|||"Eosinophil Count Over 16 Weeks~Inferential statistics were from mixed model repeated measures (MMRM) with treatment, visit, treatment by visit interaction, region, oral glucocorticosteroids use at enrollment as fixed factor, and covariate baseline value and patient as a random effect. Unstructured covariance structure was assumed for the repeated measures."||-0.418|-0.514|<0.0001
72566751|NCT01287039|144664232|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.455|STANDARD_ERROR_OF_MEAN|0.0182|<|0.0001|TWO_SIDED|95.0|-0.491|-0.419|||Mixed model repeated measures|||"Eosinophil Count Over 52 Weeks~Inferential statistics were from mixed model repeated measures (MMRM) with treatment, visit, treatment by visit interaction, region, oral glucocorticosteroids use at enrollment as fixed factor, and covariate baseline value and patient as a random effect. Unstructured covariance structure was assumed for the repeated measures."||-0.419|-0.491|<0.0001
72566752|NCT01287039|144664234|SUPERIORITY_OR_OTHER_LEGACY||CAE rate ratio (reslizumab vs placebo)|0.4499|||<|0.0001|TWO_SIDED|95.0|0.3255|0.622||The treatment effect was tested using the likelihood based Chi-square test at the 0.05 significance level.|Chi-squared|||CAE Due to Requiring Systemic Corticosteroids The frequency of CAEs was analyzed using the generalized linear model (GLM) for data from the negative binomial distributions that is commonly referred to as the negative binomial (NB) regression model. The primary NB model included the treatment group and randomization stratification factors as model factors and the logarithm of follow up time excluding the summed duration of exacerbations in the treatment period as an offset variable.||0.6220|0.3255|<0.0001
72480736|NCT06020118|144487885|SUPERIORITY|95% confidence intervals were calculated using a t-distribution on log2-transformed titers and p-values were calculated using a linear regression model adjusted for site.||||||0.238||||||GMTs and 95% confidence intervals were calculated using a t-distribution on log2-transformed titers.|Regression, Linear|||Post-vaccine: Antigen A(H3N2)||||0.238
72510107|NCT00418834|144550860|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.75|||<|0.001||95.0|1.32|2.31|||Regression, Logistic|Model terms: treatment, baseline LDL-C, and AVD status|Estimated ratio is the predictive odds of attaining LDL-C target on Atorva 10 mg + EZ versus Atorva 20 mg / Atorva 40 mg|||2.31|1.32|<0.001
72401293|NCT00362115|144310002|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.3||||0.0113|TWO_SIDED|95.0|-7.68|-0.98||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-0.98|-7.68|0.0113
72401294|NCT00362115|144310002|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.6||||0.3416|TWO_SIDED|95.0|-1.68|4.84||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||4.84|-1.68|0.3416
72510108|NCT00418834|144550861|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.9|STANDARD_ERROR_OF_MEAN|0.8|<|0.001||95.0|0.3|3.5|||ANCOVA|Model terms: treatment, baseline HDL-C, and AVD status|(Atorva 10 mg + EZ minus Atorva 20 mg)|||3.5|0.3|<0.001
72401295|NCT00362115|144310002|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2||||0.8973|TWO_SIDED|95.0|-3.49|3.06||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||3.06|-3.49|0.8973
72401296|NCT00362115|144310002|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.6||||0.7292|TWO_SIDED|95.0|-2.69|3.84||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||3.84|-2.69|0.7292
72401297|NCT00362115|144310002|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5||||0.7646|TWO_SIDED|95.0|-3.79|2.79||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||2.79|-3.79|0.7646
72401298|NCT00362115|144310002|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4||||0.8133|TWO_SIDED|95.0|-3.67|2.88||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||2.88|-3.67|0.8133
72510109|NCT00418834|144550862|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.1|STANDARD_ERROR_OF_MEAN|0.8|<|0.001||95.0|1.5|4.8|||ANCOVA|Model terms: treatment, baseline HDL-C, and AVD status|(Atorva 10 mg + EZ minus Atorva 20 mg / Atorva 40 mg)|||4.8|1.5|<0.001
72480737|NCT06020118|144487885|SUPERIORITY|95% confidence intervals were calculated using a t-distribution on log2-transformed titers and p-values were calculated using a linear regression model adjusted for site.||||||0.28||||||GMTs and 95% confidence intervals were calculated using a t-distribution on log2-transformed titers.|Regression, Linear|||Pre-vaccine: Antigen B/Victoria||||0.280
72480738|NCT06020118|144487885|SUPERIORITY|95% confidence intervals were calculated using a t-distribution on log2-transformed titers and p-values were calculated using a linear regression model adjusted for site.||||||0.094||||||GMTs and 95% confidence intervals were calculated using a t-distribution on log2-transformed titers.|Regression, Linear|||Post-vaccine: Antigen B/Victoria||||0.094
72480739|NCT06020118|144487885|SUPERIORITY|95% confidence intervals were calculated using a t-distribution on log2-transformed titers and p-values were calculated using a linear regression model adjusted for site.||||||0.216||||||GMTs and 95% confidence intervals were calculated using a t-distribution on log2-transformed titers.|Regression, Linear|||Pre-vaccine: Antigen B/Yamagata||||0.216
72480740|NCT06020118|144487885|SUPERIORITY|P values and confidence intervals for the geometric mean titer ratio were estimated using a generalized estimating equation logistic regression accounting for site clustering.||||||0.436||||||GMTs and 95% confidence intervals were calculated using a t-distribution on log2-transformed titers.|Regression, Linear|||Post-vaccine: Antigen B/Yamagata||||0.436
72480741|NCT06020118|144487885|SUPERIORITY|95% confidence intervals were calculated using a t-distribution on log2-transformed titers and p-values were calculated using a linear regression model adjusted for site.||||||0.615||||||GMTs and 95% confidence intervals were calculated using a t-distribution on log2-transformed titers.|Regression, Linear|||Pre-vaccine: Antigen A(H1N1)pdm09||||0.615
72480742|NCT06020118|144487885|SUPERIORITY|95% confidence intervals were calculated using a t-distribution on log2-transformed titers and p-values were calculated using a linear regression model adjusted for site.|||||<|0.001||||||GMTs and 95% confidence intervals were calculated using a t-distribution on log2-transformed titers.|Regression, Linear|||Post-vaccine: Antigen A(H1N1)pdm09||||<0.001
72480743|NCT06020118|144487885|SUPERIORITY|95% confidence intervals were calculated using a t-distribution on log2-transformed titers and p-values were calculated using a linear regression model adjusted for site.||||||0.87||||||GMTs and 95% confidence intervals were calculated using a t-distribution on log2-transformed titers.|Regression, Linear|||Pre-vaccine: Antigen A(H3N2)||||0.870
72510110|NCT00418834|144550863|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-12.2|STANDARD_ERROR_OF_MEAN|1.0|<|0.001||95.0|-14.2|-10.3|||ANCOVA|Model terms: treatment, baseline non-HDL-C, and AVD status|(Atorva 10 mg + EZ minus Atorva 20 mg)|||-10.3|-14.2|<0.001
72401299|NCT00362115|144310003|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.5|||<|0.0001|TWO_SIDED|95.0|-12.51|-4.51||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-4.51|-12.51|< 0.0001
72401300|NCT00362115|144310003|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.1|||<|0.0001|TWO_SIDED|95.0|-17.31|-8.9||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-8.90|-17.31|< 0.0001
72480744|NCT06020118|144487885|SUPERIORITY|95% confidence intervals were calculated using a t-distribution on log2-transformed titers and p-values were calculated using a linear regression model adjusted for site.|||||<|0.001|||||||Regression, Linear|GMTs and 95% confidence intervals were calculated using a t-distribution on log2-transformed titers.||Post-vaccine: Antigen A(H3N2)||||<0.001
72480745|NCT06020118|144487885|SUPERIORITY|95% confidence intervals were calculated using a t-distribution on log2-transformed titers and p-values were calculated using a linear regression model adjusted for site.||||||0.64||||||GMTs and 95% confidence intervals were calculated using a t-distribution on log2-transformed titers.|Regression, Linear|||Pre-vaccine: Antigen B/Victoria||||0.640
72480746|NCT06020118|144487885|SUPERIORITY|95% confidence intervals were calculated using a t-distribution on log2-transformed titers and p-values were calculated using a linear regression model adjusted for site.|||||<|0.001||||||GMTs and 95% confidence intervals were calculated using a t-distribution on log2-transformed titers.|Regression, Linear|||Post-vaccine: Antigen B/Victoria||||<0.001
72480747|NCT06020118|144487885|SUPERIORITY|95% confidence intervals were calculated using a t-distribution on log2-transformed titers and p-values were calculated using a linear regression model adjusted for site.||||||0.444||||||GMTs and 95% confidence intervals were calculated using a t-distribution on log2-transformed titers.|Regression, Linear|||Pre-vaccine: Antigen B/Yamagata||||0.444
72480748|NCT06020118|144487885|SUPERIORITY|P values and confidence intervals for the geometric mean titer ratio were estimated using a generalized estimating equation logistic regression accounting for site clustering.|||||<|0.001||||||GMTs and 95% confidence intervals were calculated using a t-distribution on log2-transformed titers.|Regression, Linear|||Post-vaccine: Antigen B/Yamagata||||<0.001
72401301|NCT00362115|144310003|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.1|||<|0.0001|TWO_SIDED|95.0|-16.27|-7.95||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-7.95|-16.27|< 0.0001
72401302|NCT00362115|144310003|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.8|||<|0.0001|TWO_SIDED|95.0|-21.07|-12.46||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-12.46|-21.07|< 0.0001
72480749|NCT06020118|144487886|SUPERIORITY|95% confidence intervals were calculated using a t-distribution on log2-transformed titers and p-values were calculated using a linear regression model adjusted for site.||||||0.793||||||Mean fold-rise and 95% confidence intervals were calculated by taking the geometric mean of each individual's ratio of post-to-pre-vaccination titers.|Regression, Linear|||Antigen: A(H1N1)pdm09||||0.793
72510111|NCT00418834|144550864|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.2|STANDARD_ERROR_OF_MEAN|1.3|<|0.001||95.0|-6.8|-1.7|||ANCOVA|Model terms: treatment, baseline non-HDL-C, and AVD status|(Atorva 10 mg + EZ minus Atorva 20 mg)|||-1.7|-6.8|<0.001
72576865|NCT00261443|144680664|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.33||||0.057|TWO_SIDED|95.0|-0.67|0.01||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 32 Comparison||0.01|-0.67|0.057
72480750|NCT06020118|144487886|SUPERIORITY|95% confidence intervals were calculated using a t-distribution on log2-transformed titers and p-values were calculated using a linear regression model adjusted for site.||||||0.326||||||Mean fold-rise and 95% confidence intervals were calculated by taking the geometric mean of each individual's ratio of post-to-pre-vaccination titers.|Regression, Linear|||Antigen: A(H3N2)||||0.326
72480751|NCT06020118|144487886|SUPERIORITY|95% confidence intervals were calculated using a t-distribution on log2-transformed titers and p-values were calculated using a linear regression model adjusted for site.||||||0.933||||||Mean fold-rise and 95% confidence intervals were calculated by taking the geometric mean of each individual's ratio of post-to-pre-vaccination titers.|Regression, Linear|||Antigen: B/Victoria||||0.933
72480752|NCT06020118|144487886|SUPERIORITY|95% confidence intervals were calculated using a t-distribution on log2-transformed titers and p-values were calculated using a linear regression model adjusted for site.||||||0.424||||||Mean fold-rise and 95% confidence intervals were calculated by taking the geometric mean of each individual's ratio of post-to-pre-vaccination titers.|Regression, Linear|||Antigen: B/Yamagata||||0.424
72480753|NCT06020118|144487886|SUPERIORITY|95% confidence intervals were calculated using a t-distribution on log2-transformed titers and p-values were calculated using a linear regression model adjusted for site.|||||<|0.001||||||Mean fold-rise and 95% confidence intervals were calculated by taking the geometric mean of each individual's ratio of post-to-pre-vaccination titers.|Regression, Linear|||Antigen: A(H1N1)pdm09||||<0.001
72480754|NCT06020118|144487886|SUPERIORITY|95% confidence intervals were calculated using a t-distribution on log2-transformed titers and p-values were calculated using a linear regression model adjusted for site.|||||<|0.001||||||Mean fold-rise and 95% confidence intervals were calculated by taking the geometric mean of each individual's ratio of post-to-pre-vaccination titers.|Regression, Linear|||Antigen: A(H3N2)||||<0.001
72480755|NCT06020118|144487886|SUPERIORITY|95% confidence intervals were calculated using a t-distribution on log2-transformed titers and p-values were calculated using a linear regression model adjusted for site.|||||<|0.001||||||Mean fold-rise and 95% confidence intervals were calculated by taking the geometric mean of each individual's ratio of post-to-pre-vaccination titers.|Regression, Linear|||Antigen: B/Victoria||||<0.001
72401303|NCT00362115|144310003|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.4|||<|0.0001|TWO_SIDED|95.0|-17.58|-9.17||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-9.17|-17.58|< 0.0001
72401304|NCT00362115|144310003|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.7||||0.3735|TWO_SIDED|95.0|-2.1|5.58||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||5.58|-2.10|0.3735
72401305|NCT00362115|144310003|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.9||||0.1668|TWO_SIDED|95.0|-6.91|1.2||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||1.20|-6.91|0.1668
72401306|NCT00362115|144310003|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.9||||0.3629|TWO_SIDED|95.0|-5.86|2.15||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||2.15|-5.86|0.3629
72480756|NCT06020118|144487886|SUPERIORITY|95% confidence intervals were calculated using a t-distribution on log2-transformed titers and p-values were calculated using a linear regression model adjusted for site.|||||<|0.001||||||Mean fold-rise and 95% confidence intervals were calculated by taking the geometric mean of each individual's ratio of post-to-pre-vaccination titers.|Regression, Linear|||Antigen: B/Yamagata||||<0.001
72480757|NCT01281969|144487910|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.97||||0.44|TWO_SIDED|95.0|-7.1|3.15||p-value is unadjusted. a priori threshold for statistical significance is .05|ANCOVA|F(1,34)=0.62, p=.44||Analysis of covariance model controlling for baseline scores. A priori power calculations based on the Perlmutter et al. study (IVIG effect size 1.2) suggested that a sample size of 16 per group would be sufficient to detect an effect size of 1.0 with 80% power.||3.15|-7.1|0.44
72480758|NCT01281969|144487911|SUPERIORITY_OR_OTHER_LEGACY|||||||0.12||||||p-value is not adjusted.|Wilcoxon (Mann-Whitney)|Mean rank sum in the placebo group = 19.92; mean rank sum in the IVIG group = 15.97. Z = -1.18, p=.12||The Wilcoxon two-sample test was used to compare CGI-Improvement ratings (an ordinal variable) at week 6. Power calculation was based on CYBOCS as primary outcome.||||.12
72480759|NCT01281969|144487912|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4||||||p-value is not adjusted for multiple comparisons.|Chi-squared|X2 = 0.72, p=.40||Chi-squared test was used to compare distribution of responders by randomization group. Power calculation was based on CY-BOCS (primary outcome).||||.40
72480760|NCT01257425|144487938|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence margin defined as 0.8 to 1.25|Ratio of AUC values|0.977|||||TWO_SIDED|90.0|0.88|1.08|||ANCOVA|||||1.08|0.88|
72480761|NCT01257425|144487939|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence margin is 0.8 to 1.25|Ratio of AUC values|0.932|||||TWO_SIDED|90.0|0.82|1.06|||ANCOVA|||||1.06|0.82|
72401307|NCT00362115|144310003|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.5||||0.0022|TWO_SIDED|95.0|-10.67|-2.36||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-2.36|-10.67|0.0022
72480762|NCT01257425|144487940|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence margin is 0.8 to 1.25|Ratio of AUC values|0.91|||||TWO_SIDED|90.0|0.81|1.02|||ANCOVA|||||1.02|0.81|
72480763|NCT01257425|144487942|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.01||||0.85|TWO_SIDED|95.0|-0.09|0.11|||ANCOVA|||||0.11|-0.09|0.85
72480764|NCT01257425|144487943|SUPERIORITY_OR_OTHER|||||||0.98||95.0|||||Log Rank|||||||0.98
72480765|NCT01257425|144487944|SUPERIORITY_OR_OTHER|||||||0.84|||||||Log Rank|||||||0.84
72480766|NCT01182194|144487945|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|92.5|||||TWO_SIDED|90.0|85.53|100.03|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||100.03|85.53|
72480767|NCT01182194|144487946|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|98.76|||||TWO_SIDED|90.0|95.66|101.96|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||101.96|95.66|
72480768|NCT01182194|144487947|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|98.47|||||TWO_SIDED|90.0|95.35|101.7|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||101.70|95.35|
72480769|NCT01182194|144487948|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|101.45|||||TWO_SIDED|90.0|94.36|109.08|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||109.08|94.36|
72480770|NCT01182194|144487949|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|98.54|||||TWO_SIDED|90.0|94.55|102.71|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||102.71|94.55|
72480771|NCT01182194|144487950|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|99.7|||||TWO_SIDED|90.0|96.07|103.46|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||103.46|96.07|
72510112|NCT00418834|144550865|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-7.9|STANDARD_ERROR_OF_MEAN|0.7|<|0.001||95.0|-9.4|-6.5|||ANCOVA|Model terms: treatment, baseline Total Cholesterol, and AVD status|(Atorva 10 mg + EZ minus Atorva 20 mg)|||-6.5|-9.4|<0.001
72510113|NCT00418834|144550866|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.0|STANDARD_ERROR_OF_MEAN|0.9|<|0.001||95.0|-3.8|-0.2|||ANCOVA|Model terms: treatment, baseline Total Cholesterol, and AVD status|(Atorva 10 mg + EZ minus Atorva 20 mg / Atorva 40 mg)|||-0.2|-3.8|<0.001
72510114|NCT00418834|144550867|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-6.2|||<|0.001||95.0|-9.0|-3.4|||Nonparametric ANCOVA|ANCOVA using ranks based on normal scores (Tukey method) with model terms for treatment, baseline TG value (normalized scores), and AVD status|"(Atorva 10 mg + EZ minus Atorva 20 mg)~The median difference is based on the Hodges-Lehmann estimates of shift; The distribution-free 95% CI is based on Wilcoxon's rank sum test statistic"|||-3.4|-9.0|<0.001
72480772|NCT04262817|144487951|SUPERIORITY|||||||0.01|||||||Mixed Models Analysis|||Comparison of Nicotine type.||||0.01
72480773|NCT04262817|144487951|SUPERIORITY|||||||0.34|||||||Mixed Models Analysis|||Comparison of Flavor type.||||0.34
72480774|NCT04262817|144487952|SUPERIORITY|||||||0.38|||||||Mixed Models Analysis|||Comparison of Nicotine type.||||0.38
72480775|NCT04262817|144487952|SUPERIORITY|||||||0.85|||||||Mixed Models Analysis|||Comparison of Flavor type.||||0.85
72510115|NCT00418834|144550868|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-2.1|||<|0.001||95.0|-5.2|1.0|||Nonparametric ANCOVA|ANCOVA using ranks based on normal scores (Tukey method) with model terms for treatment, baseline TG value (normalized scores), and AVD status|"(Atorva 10 mg + EZ minus Atorva 20 mg)~The median difference is based on the Hodges-Lehmann estimates~of shift; The distribution-free 95% CI is based on Wilcoxon's rank sum test statistic"|||1.0|-5.2|<0.001
72510116|NCT00418834|144550869|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-9.1|STANDARD_ERROR_OF_MEAN|0.9|<|0.001||95.0|-11.0|-7.3|||ANCOVA|Model terms: treatment, baseline Apo B, and AVD status|(Atorva 10 mg + EZ minus Atorva 20 mg)|||-7.3|-11.0|<0.001
72510117|NCT00418834|144550870|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.2|STANDARD_ERROR_OF_MEAN|1.2|<|0.001||95.0|-5.5|-0.9|||ANCOVA|Model terms: treatment, baseline Apo B, and AVD status|(Atorva 10 mg + EZ minus Atorva 20 mg / Atorva 40 mg)|||-0.9|-5.5|<0.001
72510118|NCT00418834|144550871|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.6|STANDARD_ERROR_OF_MEAN|0.8||0.401||95.0|-0.9|2.1|||ANCOVA|Model terms: treatment, baseline Apo A-I, and AVD status|(Atorva 10 mg + EZ minus Atorva 20 mg)|||2.1|-0.9|0.401
72510119|NCT00418834|144550872|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.7|STANDARD_ERROR_OF_MEAN|0.8|<|0.001||95.0|1.1|4.2|||ANCOVA|Model terms: treatment, baseline Apo A-I, and AVD status|(Atorva 10 mg + EZ minus Atorva 20 mg / Atorva 40 mg)|||4.2|1.1|<0.001
72401308|NCT00362115|144310003|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.1||||0.1303|TWO_SIDED|95.0|-7.18|0.93||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||0.93|-7.18|0.1303
72401309|NCT00362115|144310004|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.4|||<|0.0001|TWO_SIDED|95.0|-8.12|-2.72||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-2.72|-8.12|< 0.0001
72480776|NCT04262817|144487953|SUPERIORITY|||||||0.39|||||||Mixed Models Analysis|||Comparison of Nicotine type.||||0.39
72480777|NCT04262817|144487953|SUPERIORITY|||||||0.77|||||||Mixed Models Analysis|||Comparison of Flavor type.||||0.77
72401310|NCT00362115|144310004|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.5|||<|0.0001|TWO_SIDED|95.0|-11.33|-5.65||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-5.65|-11.33|< 0.0001
72480778|NCT04262817|144487954|SUPERIORITY|||||||0.43|||||||Mixed Models Analysis|||Comparison of Nicotine type.||||0.43
72480779|NCT04262817|144487954|SUPERIORITY|||||||0.05|||||||Mixed Models Analysis|||Comparison of Flavor type.||||0.05
72401311|NCT00362115|144310004|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.7|||<|0.0001|TWO_SIDED|95.0|-11.52|-5.9||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-5.90|-11.52|< 0.0001
72401312|NCT00362115|144310004|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.8|||<|0.0001|TWO_SIDED|95.0|-13.73|-7.91||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-7.91|-13.73|< 0.0001
72480780|NCT04262817|144487955|SUPERIORITY|||||||0.05|||||||Mixed Models Analysis|||Comparison of Nicotine type.||||0.05
72401313|NCT00362115|144310004|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.5|||<|0.0001|TWO_SIDED|95.0|-12.31|-6.64||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-6.64|-12.31|< 0.0001
72401314|NCT00362115|144310004|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.0||||0.1249|TWO_SIDED|95.0|-0.56|4.61||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||4.61|-0.56|0.1249
72401315|NCT00362115|144310004|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0||||0.4542|TWO_SIDED|95.0|-3.79|1.7||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||1.70|-3.79|0.4542
72480781|NCT04262817|144487955|SUPERIORITY|||||||0.04|||||||Mixed Models Analysis|||Comparison of Flavor type.||||0.04
72480782|NCT04262817|144487956|SUPERIORITY|||||||0.01|||||||Mixed Models Analysis|||Comparison of Nicotine type.||||0.01
72480783|NCT04262817|144487956|SUPERIORITY|||||||0.38|||||||Mixed Models Analysis|||Comparison of Flavor type.||||0.38
72401316|NCT00362115|144310004|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.3||||0.3574|TWO_SIDED|95.0|-3.97|1.44||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||1.44|-3.97|0.3574
72480784|NCT02668185|144487961|SUPERIORITY|Generalised linear mixed model with a Poisson error structure|Mean Difference (Net)|29.66|||<|0.0001|TWO_SIDED|95.0|17.39|42.87||Intention to treat adjusted means.|generalised linear mixed model with a Po|Adjusted for intention to treat||||42.87|17.39|<0.0001
72480785|NCT02668185|144487962|SUPERIORITY||Mean Difference (Net)|50.0|||<|0.05|TWO_SIDED|95.0|||||Mixed Models Analysis|||||||<0.05
72480786|NCT02668185|144487963|SUPERIORITY||||||<|0.05|||||||Mixed Models Analysis|||||||<0.05
72480787|NCT02668185|144487964|SUPERIORITY||||||<|0.05|TWO_SIDED|95.0|||||Mixed Models Analysis|||||||<0.05
72480788|NCT02668185|144487965|SUPERIORITY||||||<|0.05|TWO_SIDED|95.0|||||Mixed Models Analysis|||||||<0.05
72480789|NCT00883051|144488019|OTHER|A hierarchical test procedure was applied only for analysis of the primary efficacy endpoint.|||||<|0.0001|||||||Cochran-Armitage test for trend|||||||<0.0001
72480790|NCT00883051|144488020|OTHER|A hierarchical test procedure was applied only for analysis of the primary efficacy endpoint.|||||=|0.0006|||||||Cochran-Armitage test for trend]|||||||=0.0006
72480791|NCT03373201|144488043|SUPERIORITY||Difference between LS means|60.3|||<|0.0001|TWO_SIDED|95.0|44.0|76.7|||ANOVA|||||76.7|44.0|<.0001
72480792|NCT03373201|144488044|SUPERIORITY||Difference between LS Means.|85.5|||<|0.0001|TWO_SIDED|95.0|64.3|106.6|||ANOVA|||||106.6|64.3|<.0001
72480793|NCT03373201|144488045|SUPERIORITY||Difference between LS means|-15.1|||<|0.0001|TWO_SIDED|95.0|-26.2|-4.0|||ANOVA|||||-4.0|-26.2|<.0001
72480794|NCT03373201|144488046|SUPERIORITY||Difference between LS means|-74.6|||<|0.0001|TWO_SIDED|95.0|-94.8|-54.3|||ANOVA|||||-54.3|-94.8|<.0001
72480795|NCT03373201|144488047|SUPERIORITY||Difference between LS Means.|-0.5||||0.0083|TWO_SIDED|95.0|-0.9|-0.1|||ANOVA|||||-0.1|-0.9|0.0083
72480796|NCT03373201|144488048|SUPERIORITY||Difference between LS Means.|6.6||||0.0099|TWO_SIDED|95.0|1.6|11.6|||ANOVA|||||11.6|1.6|0.0099
72480797|NCT02618642|144488049|SUPERIORITY|||||||0.3879|||||||Wilcoxon (Mann-Whitney)|||the results in the irradiated group (n=45) and the control group (n=15) were compared||||0.3879
72401317|NCT00362115|144310004|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.4||||0.0184|TWO_SIDED|95.0|-6.18|-0.57||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-0.57|-6.18|0.0184
72401318|NCT00362115|144310004|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.0||||0.145|TWO_SIDED|95.0|-4.77|0.7||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||0.70|-4.77|0.1450
72401319|NCT00362115|144310005|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.9||||0.0009|TWO_SIDED|95.0|-12.46|-3.26||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-3.26|-12.46|0.0009
72401320|NCT00362115|144310005|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.6|||<|0.0001|TWO_SIDED|95.0|-18.46|-8.77||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-8.77|-18.46|< 0.0001
72401321|NCT00362115|144310005|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.4|||<|0.0001|TWO_SIDED|95.0|-17.21|-7.63||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-7.63|-17.21|< 0.0001
72401322|NCT00362115|144310005|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.9|||<|0.0001|TWO_SIDED|95.0|-22.83|-12.92||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-12.92|-22.83|< 0.0001
72401323|NCT00362115|144310005|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.7|||<|0.0001|TWO_SIDED|95.0|-18.52|-8.84||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-8.84|-18.52|< 0.0001
72401324|NCT00362115|144310005|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2||||0.9424|TWO_SIDED|95.0|-4.25|4.58||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||4.58|-4.25|0.9424
72401325|NCT00362115|144310005|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.6||||0.0189|TWO_SIDED|95.0|-10.26|-0.93||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-0.93|-10.26|0.0189
72401326|NCT00362115|144310005|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.4||||0.0612|TWO_SIDED|95.0|-9.01|0.21||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||0.21|-9.01|0.0612
72401327|NCT00362115|144310005|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.9|||<|0.0001|TWO_SIDED|95.0|-14.63|-5.07||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-5.07|-14.63|< 0.0001
72401328|NCT00362115|144310005|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.7||||0.0175|TWO_SIDED|95.0|-10.33|-1.0||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-1.00|-10.33|0.0175
72401329|NCT00362115|144310006|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.1||||0.0108|TWO_SIDED|95.0|-7.26|-0.95||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-0.95|-7.26|0.0108
72480798|NCT02618642|144488049|SUPERIORITY|||||||0.5361|||||||Kruskal-Wallis|||comparison was conducted of the results obtained with a different filter were compared||||0.5361
72401330|NCT00362115|144310006|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.9|||<|0.0001|TWO_SIDED|95.0|-11.16|-4.55||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-4.55|-11.16|< 0.0001
72401331|NCT00362115|144310006|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.5|||<|0.0001|TWO_SIDED|95.0|-11.82|-5.26||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-5.26|-11.82|< 0.0001
72401332|NCT00362115|144310006|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.6|||<|0.0001|TWO_SIDED|95.0|-13.98|-7.2||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-7.20|-13.98|< 0.0001
72401333|NCT00362115|144310006|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.2|||<|0.0001|TWO_SIDED|95.0|-12.52|-5.9||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-5.90|-12.52|< 0.0001
72401334|NCT00362115|144310006|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.6||||0.306|TWO_SIDED|95.0|-1.45|4.59||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||4.59|-1.45|0.3060
72401335|NCT00362115|144310006|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.2||||0.1823|TWO_SIDED|95.0|-5.37|1.02||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||1.02|-5.37|0.1823
72401336|NCT00362115|144310006|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.9||||0.0751|TWO_SIDED|95.0|-6.01|0.29||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||0.29|-6.01|0.0751
72401337|NCT00362115|144310006|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.9||||0.0034|TWO_SIDED|95.0|-8.18|-1.64||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-1.64|-8.18|0.0034
72401338|NCT00362115|144310006|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.5||||0.0306|TWO_SIDED|95.0|-6.72|-0.33||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-0.33|-6.72|0.0306
72401339|NCT00362115|144310007|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.1||||0.0061|TWO_SIDED|95.0|-13.9|-2.33||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-2.33|-13.90|0.0061
72401340|NCT00362115|144310007|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.5||||0.0002|TWO_SIDED|95.0|-17.56|-5.44||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-5.44|-17.56|0.0002
72401341|NCT00362115|144310007|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.3|||<|0.0001|TWO_SIDED|95.0|-18.34|-6.28||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-6.28|-18.34|< 0.0001
72401342|NCT00362115|144310007|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.5|||<|0.0001|TWO_SIDED|95.0|-23.75|-11.34||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-11.34|-23.75|< 0.0001
72401343|NCT00362115|144310007|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.8|||<|0.0001|TWO_SIDED|95.0|-19.86|-7.8||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-7.80|-19.86|< 0.0001
72401344|NCT00362115|144310007|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2||||0.9355|TWO_SIDED|95.0|-5.74|5.28||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||5.28|-5.74|0.9355
72401345|NCT00362115|144310007|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.6||||0.2223|TWO_SIDED|95.0|-9.41|2.2||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||2.20|-9.41|0.2223
72401346|NCT00362115|144310007|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.4||||0.1328|TWO_SIDED|95.0|-10.19|1.35||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||1.35|-10.19|0.1328
72401347|NCT00362115|144310007|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.7||||0.0016|TWO_SIDED|95.0|-15.61|-3.7||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-3.70|-15.61|0.0016
72401348|NCT00362115|144310007|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.9||||0.0437|TWO_SIDED|95.0|-11.7|-0.17||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-0.17|-11.70|0.0437
72401349|NCT00362115|144310008|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.3||||0.0417|TWO_SIDED|95.0|-8.39|-0.16||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-0.16|-8.39|0.0417
72401350|NCT00362115|144310008|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.1||||0.0053|TWO_SIDED|95.0|-10.44|-1.84||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-1.84|-10.44|0.0053
72401351|NCT00362115|144310008|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.8||||0.0004|TWO_SIDED|95.0|-12.12|-3.56||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-3.56|-12.12|0.0004
72401352|NCT00362115|144310008|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.6|||<|0.0001|TWO_SIDED|95.0|-13.97|-5.16||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-5.16|-13.97|< 0.0001
72401353|NCT00362115|144310008|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.3|||<|0.0001|TWO_SIDED|95.0|-13.6|-5.03||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-5.03|-13.60|< 0.0001
72401354|NCT00362115|144310008|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.9||||0.6372|TWO_SIDED|95.0|-2.97|4.85||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||4.85|-2.97|0.6372
72480799|NCT02618642|144488050|SUPERIORITY|||||||0.4669|||||||Wilcoxon (Mann-Whitney)|||the results in the irradiated group (n=45) vs the control group (placebo) (n=15) were compared.||||0.4669
72401355|NCT00362115|144310008|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9||||0.6588|TWO_SIDED|95.0|-5.05|3.2||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||3.20|-5.05|0.6588
72401356|NCT00362115|144310008|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.6||||0.2082|TWO_SIDED|95.0|-6.72|1.47||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||1.47|-6.72|0.2082
72401357|NCT00362115|144310008|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.3||||0.0437|TWO_SIDED|95.0|-8.57|-0.12||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-0.12|-8.57|0.0437
72401358|NCT00362115|144310008|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.1||||0.0495|TWO_SIDED|95.0|-8.19|-0.01||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-0.01|-8.19|0.0495
72480800|NCT02618642|144488050|SUPERIORITY|||||||0.4161|||||||Kruskal-Wallis|||||||0.4161
72401359|NCT00362115|144310009|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.4||||0.0007|TWO_SIDED|95.0|-14.74|-3.97||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-3.97|-14.74|0.0007
72401360|NCT00362115|144310009|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.4|||<|0.0001|TWO_SIDED|95.0|-19.02|-7.73||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-7.73|-19.02|< 0.0001
72401361|NCT00362115|144310009|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.4||||0.0003|TWO_SIDED|95.0|-16.0|-4.83||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-4.83|-16.00|0.0003
72401362|NCT00362115|144310009|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.3|||<|0.0001|TWO_SIDED|95.0|-23.11|-11.47||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-11.47|-23.11|< 0.0001
72401363|NCT00362115|144310009|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.4|||<|0.0001|TWO_SIDED|95.0|-18.01|-6.78||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-6.78|-18.01|< 0.0001
72401364|NCT00362115|144310009|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.9||||0.2594|TWO_SIDED|95.0|-2.17|8.01||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||8.01|-2.17|0.2594
72401365|NCT00362115|144310009|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.1||||0.6859|TWO_SIDED|95.0|-6.46|4.26||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||4.26|-6.46|0.6859
72401366|NCT00362115|144310009|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.9||||0.4898|TWO_SIDED|95.0|-3.43|7.15||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||7.15|-3.43|0.4898
72401367|NCT00362115|144310009|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.0||||0.076|TWO_SIDED|95.0|-10.55|0.53||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||0.53|-10.55|0.0760
72401368|NCT00362115|144310009|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.9647|TWO_SIDED|95.0|-5.44|5.21||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||5.21|-5.44|0.9647
72401369|NCT00362115|144310010|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.3||||0.0002|TWO_SIDED|95.0|-11.13|-3.43||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-3.43|-11.13|0.0002
72401370|NCT00362115|144310010|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.0|||<|0.0001|TWO_SIDED|95.0|-15.01|-6.97||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-6.97|-15.01|< 0.0001
72401371|NCT00362115|144310010|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.6|||<|0.0001|TWO_SIDED|95.0|-12.59|-4.64||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-4.64|-12.59|< 0.0001
72401372|NCT00362115|144310010|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.6|||<|0.0001|TWO_SIDED|95.0|-17.79|-9.5||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-9.50|-17.79|< 0.0001
72401373|NCT00362115|144310010|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.7|||<|0.0001|TWO_SIDED|95.0|-12.69|-4.7||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-4.70|-12.69|< 0.0001
72480801|NCT02618642|144488051|SUPERIORITY|||||||0.9596|||||||Wilcoxon (Mann-Whitney)|||the results in the irradiated group (n=45) and the control group (n=15) were compared.||||0.9596
72480802|NCT02618642|144488051|SUPERIORITY|||||||0.0907|||||||Kruskal-Wallis|||||||0.0907
72480803|NCT02618642|144488052|SUPERIORITY|||||||0.011|||||||Wilcoxon (Mann-Whitney)|||the results in the irradiated group (n=45) and the control group (n=15) were compared.||||0.0110
72480804|NCT02618642|144488052|SUPERIORITY|||||||0.1165|||||||Kruskal-Wallis|||comparison was conducted of the results obtained with a different filter (groups v, x, y,||||0.1165
72480805|NCT02618642|144488053|SUPERIORITY|||||||0.02|||||||Wilcoxon (Mann-Whitney)|||he results in the irradiated group (n=45) and the control group (n=15) were compared||||0.0200
72480806|NCT02618642|144488053|SUPERIORITY|comparison was conducted of the results obtained with a different filter (groups v, x, y,||||||0.0014|||||||Kruskal-Wallis|||||||0.0014
72480807|NCT01078220|144488190|SUPERIORITY_OR_OTHER||Relative Risk|6.0|||||TWO_SIDED|95.0|3.91|9.21|||unconditional logistic regression||Relative risk was approximated by odds ratio, obtained from conditional logistic regression.|||9.21|3.91|
72480808|NCT01078220|144488190|SUPERIORITY_OR_OTHER||Relative Risk|2.88|||||TWO_SIDED|95.0|1.18|7.08|||unconditional logistic regression||Relative risk was approximated by odds ratio, obtained from conditional logistic regression.|||7.08|1.18|
72480809|NCT01078220|144488194|SUPERIORITY_OR_OTHER||Relative Risk|1.64|||||TWO_SIDED|95.0|1.17|2.3|||unconditional logistic regression||Relative risk was approximated by odds ratio, obtained from conditional logistic regression.|Days 1-14 after vaccination.||2.3|1.17|
72480810|NCT01078220|144488194|SUPERIORITY_OR_OTHER||Relative Risk|1.05|||||TWO_SIDED|95.0|0.82|1.35|||unconditional logistic regression||Relative risk was approximated by odds ratio, obtained from conditional logistic regression.|Days 1-60 after vaccination.||1.35|0.82|
72401374|NCT00362115|144310010|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.0||||0.279|TWO_SIDED|95.0|-1.63|5.62||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||5.62|-1.63|0.2790
72401375|NCT00362115|144310010|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.7||||0.3772|TWO_SIDED|95.0|-5.53|2.1||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||2.10|-5.53|0.3772
72401376|NCT00362115|144310010|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.7||||0.7302|TWO_SIDED|95.0|-3.11|4.43||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||4.43|-3.11|0.7302
72401377|NCT00362115|144310010|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.4||||0.0302|TWO_SIDED|95.0|-8.31|-0.42||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-0.42|-8.31|0.0302
72401378|NCT00362115|144310010|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.6||||0.7644|TWO_SIDED|95.0|-3.22|4.38||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||4.38|-3.22|0.7644
72401379|NCT00362115|144310011|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.4||||0.0001|TWO_SIDED|95.0|-12.7|-4.19||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-4.19|-12.70|0.0001
72401380|NCT00362115|144310011|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.7|||<|0.0001|TWO_SIDED|95.0|-18.19|-9.24||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-9.24|-18.19|< 0.0001
72480811|NCT01078220|144488194|SUPERIORITY_OR_OTHER||Relative Risk|1.02|||||TWO_SIDED|95.0|0.53|1.98|||unconditional logistic regression||Relative risk was approximated by odds ratio, obtained from conditional logistic regression.|Days 1-14 after vaccination.||1.98|0.53|
72480812|NCT01078220|144488194|SUPERIORITY_OR_OTHER||Relative Risk|0.78|||||TWO_SIDED|95.0|0.5|1.21|||unconditional logistic regression||Relative risk was approximated by odds ratio, obtained from conditional logistic regression.|Days 1-60 after vaccination.||1.21|0.5|
72510120|NCT00418834|144550873|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-9.0|STANDARD_ERROR_OF_MEAN|0.9|<|0.001||95.0|-10.7|-7.3|||ANCOVA|Model terms: treatment, baseline Total-C:HDL-C, and AVD status|(Atorva 10 mg + EZ minus Atorva 20 mg)|||-7.3|-10.7|<0.001
72401381|NCT00362115|144310011|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.2|||<|0.0001|TWO_SIDED|95.0|-16.66|-7.8||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-7.80|-16.66|< 0.0001
72401382|NCT00362115|144310011|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.9|||<|0.0001|TWO_SIDED|95.0|-22.51|-13.35||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-13.35|-22.51|< 0.0001
72401383|NCT00362115|144310011|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.7|||<|0.0001|TWO_SIDED|95.0|-18.21|-9.25||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-9.25|-18.21|< 0.0001
72510121|NCT00418834|144550874|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.6|STANDARD_ERROR_OF_MEAN|1.1|<|0.001||95.0|-6.8|-2.4|||ANCOVA|Model terms: treatment, baseline Total-C:HDL-C, and AVD status|(Atorva 10 mg + EZ minus Atorva 20 mg / Atorva 40 mg)|||-2.4|-6.8|<0.001
72510122|NCT00418834|144550875|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-14.6|STANDARD_ERROR_OF_MEAN|1.2|<|0.001||95.0|-17.0|-12.2|||ANCOVA|Model terms: treatment, baseline LDL-C:HDL-C, and AVD status|(Atorva 10 mg + EZ minus Atorva 20 mg)|||-12.2|-17.0|<0.001
72401384|NCT00362115|144310011|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.8||||0.6905|TWO_SIDED|95.0|-3.26|4.91||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||4.91|-3.26|0.6905
72401385|NCT00362115|144310011|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.4||||0.0433|TWO_SIDED|95.0|-8.76|-0.13||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-0.13|-8.76|0.0433
72401386|NCT00362115|144310011|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.0||||0.1736|TWO_SIDED|95.0|-7.22|1.31||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||1.31|-7.22|0.1736
72401387|NCT00362115|144310011|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.7||||0.0001|TWO_SIDED|95.0|-13.08|-4.23||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-4.23|-13.08|0.0001
72401388|NCT00362115|144310011|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.5||||0.0429|TWO_SIDED|95.0|-8.77|-0.14||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANOVA|||||-0.14|-8.77|0.0429
72401389|NCT00362115|144310012|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.9||||0.0009|TWO_SIDED|95.0|-7.77|-2.04||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-2.04|-7.77|0.0009
72401390|NCT00362115|144310012|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.3|||<|0.0001|TWO_SIDED|95.0|-11.33|-5.32||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-5.32|-11.33|< 0.0001
72401391|NCT00362115|144310012|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.7|||<|0.0001|TWO_SIDED|95.0|-11.63|-5.67||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-5.67|-11.63|< 0.0001
72480813|NCT03824639|144488199|OTHER|Cohen's d will be used to estimate the effect size for comparing change in outcome measurements over 6 months in the exercise group to the control group. This effect size will be used for sample size calculations.|Cohen's d|0.37|||||TWO_SIDED|||||||||||||
72401392|NCT00362115|144310012|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.3|||<|0.0001|TWO_SIDED|95.0|-14.34|-8.18||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-8.18|-14.34|< 0.0001
72401393|NCT00362115|144310012|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.4|||<|0.0001|TWO_SIDED|95.0|-12.37|-6.36||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-6.36|-12.37|< 0.0001
72401394|NCT00362115|144310012|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.8||||0.2068|TWO_SIDED|95.0|-0.98|4.5||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||4.50|-0.98|0.2068
72480814|NCT03824639|144488200|OTHER|Cohen's d will be used to estimate the effect size for comparing change in outcome measurements over 6 months in the exercise group to the control group. This effect size will be used for sample size calculations.|Cohen's d|0.18|||||TWO_SIDED|||||||||||||
72480815|NCT01786174|144488204|SUPERIORITY_OR_OTHER||Slope|1.4|STANDARD_ERROR_OF_MEAN|4.3||0.746|TWO_SIDED|95.0|-7.17|9.96|||Random slopes model|||Fingolimod vs. Placebo Weeks 0-4||9.96|-7.17|0.746
72480816|NCT01786174|144488205|SUPERIORITY_OR_OTHER||Slope|0.25|STANDARD_ERROR_OF_MEAN|0.89||0.78|TWO_SIDED|95.0|-1.53|2.03|||Random slopes model|||Fingolimod vs. Placebo Weeks 0-4||2.03|-1.53|0.780
72480817|NCT01786174|144488206|SUPERIORITY_OR_OTHER||Slope|-0.51|STANDARD_ERROR_OF_MEAN|2.26||0.823|TWO_SIDED|95.0|-5.0|3.99|||Random slopes model|||Fingolimod vs. Placebo Weeks 0-4||3.99|-5.00|0.823
72480818|NCT01786174|144488208|SUPERIORITY_OR_OTHER||Slope|4.27|STANDARD_ERROR_OF_MEAN|4.04||0.294|TWO_SIDED|95.0|-3.78|12.33|||Random slopes model|||Fingolimod vs. Placebo Weeks 0-4||12.33|-3.78|0.294
72480819|NCT01620255|144488209|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|0.08||||0.0213|TWO_SIDED|90.0|0.019|0.14||1-sided p-value|Cochran-Mantel-Haenszel|Statistics of risk difference are calculated using the Minimum Risk Weights test.|Statistics of risk difference are calculated using the Minimum Risk Weights test.|PF-00547659 7.5 mg versus (vs) placebo, centrally read||0.140|0.019|0.0213
72480820|NCT01620255|144488209|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|0.128||||0.0025|TWO_SIDED|90.0|0.056|0.199||1-sided p-value|Cochran-Mantel-Haenszel|Statistics of risk difference are calculated using the Minimum Risk Weights test.|Statistics of risk difference are calculated using the Minimum Risk Weights test.|PF-00547659 22.5 mg vs placebo, centrally read||0.199|0.056|0.0025
72480821|NCT01620255|144488209|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|0.118||||0.004|TWO_SIDED|90.0|0.048|0.188||1-sided p-value|Cochran-Mantel-Haenszel|Statistics of risk difference are calculated using the Minimum Risk Weights test.|Statistics of risk difference are calculated using the Minimum Risk Weights test.|PF-00547659 75 mg vs placebo, centrally read||0.188|0.048|0.0040
72480822|NCT01620255|144488209|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|0.026||||0.1803|TWO_SIDED|90.0|-0.012|0.064||1-sided p-value|Cochran-Mantel-Haenszel|Statistics of risk difference are calculated using the Minimum Risk Weights test.|Statistics of risk difference are calculated using the Minimum Risk Weights test.|PF-00547659 225 mg vs placebo, centrally read||0.064|-0.012|0.1803
72480823|NCT01620255|144488209|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|0.08||||0.0582|TWO_SIDED|90.0|0.002|0.159||1-sided p-value|Cochran-Mantel-Haenszel|Statistics of risk difference are calculated using the Minimum Risk Weights test.|Statistics of risk difference are calculated using the Minimum Risk Weights test.|PF-00547659 7.5 mg vs placebo, locally read||0.159|0.002|0.0582
72480824|NCT01620255|144488209|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|0.178||||0.0014|TWO_SIDED|90.0|0.083|0.272||1-sided p-value|Cochran-Mantel-Haenszel|Statistics of risk difference are calculated using the Minimum Risk Weights test.|Statistics of risk difference are calculated using the Minimum Risk Weights test.|PF-00547659 22.5 mg vs placebo, locally read||0.272|0.083|0.0014
72510123|NCT00418834|144550876|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.9|STANDARD_ERROR_OF_MEAN|1.7|<|0.001||95.0|-10.1|-3.7|||ANCOVA|Model terms: treatment, baseline LDL-C:HDL-C, and AVD status|(Atorva 10 mg + EZ minus Atorva 20 mg / Atorva 40 mg)|||-3.7|-10.1|<0.001
72480825|NCT01620255|144488209|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|0.122||||0.0125|TWO_SIDED|90.0|0.036|0.208||1-sided p-value|Cochran-Mantel-Haenszel|Statistics of risk difference are calculated using the Minimum Risk Weights test.|Statistics of risk difference are calculated using the Minimum Risk Weights test.|PF-00547659 75 mg vs placebo, locally read||0.208|0.036|0.0125
72480826|NCT01620255|144488209|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|0.066||||0.0927|TWO_SIDED|90.0|-0.009|0.142||1-sided p-value|Cochran-Mantel-Haenszel|Statistics of risk difference are calculated using the Minimum Risk Weights test.|Statistics of risk difference are calculated using the Minimum Risk Weights test.|PF-00547659 225 mg vs placebo, locally read||0.142|-0.009|0.0927
72480827|NCT01620255|144488210|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|0.089||||0.1379|TWO_SIDED|90.0|-0.037|0.214||1-sided p-value|Cochran-Mantel-Haenszel|Statistics of risk difference are calculated using the Minimum Risk Weights test.|Statistics of risk difference are calculated using the Minimum Risk Weights test.|PF-00547659 7.5 mg vs placebo, centrally read||0.214|-0.037|0.1379
72480828|NCT01620255|144488210|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|0.254||||0.0011|TWO_SIDED|90.0|0.121|0.388||1-sided p-value|Cochran-Mantel-Haenszel|Statistics of risk difference are calculated using the Minimum Risk Weights test.|Statistics of risk difference are calculated using the Minimum Risk Weights test.|PF-00547659 22.5 mg vs placebo, centrally read||0.388|0.121|0.0011
72480829|NCT01620255|144488210|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|0.163||||0.0239|TWO_SIDED|90.0|0.032|0.293||1-sided p-value|Cochran-Mantel-Haenszel|Statistics of risk difference are calculated using the Minimum Risk Weights test.|Statistics of risk difference are calculated using the Minimum Risk Weights test.|PF-00547659 75 mg vs placebo, centrally read||0.293|0.032|0.0239
72480830|NCT01620255|144488210|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|0.213||||0.0052|TWO_SIDED|90.0|0.08|0.347||1-sided p-value|Cochran-Mantel-Haenszel|Statistics of risk difference are calculated using the Minimum Risk Weights test.|Statistics of risk difference are calculated using the Minimum Risk Weights test.|PF-00547659 225 mg vs placebo, centrally read||0.347|0.080|0.0052
72401395|NCT00362115|144310012|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.7||||0.2622|TWO_SIDED|95.0|-4.56|1.25||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||1.25|-4.56|0.2622
72401396|NCT00362115|144310012|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.0||||0.173|TWO_SIDED|95.0|-4.85|0.88||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||0.88|-4.85|0.1730
72401397|NCT00362115|144310012|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.6||||0.0025|TWO_SIDED|95.0|-7.56|-1.62||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-1.62|-7.56|0.0025
72401398|NCT00362115|144310012|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.7||||0.0681|TWO_SIDED|95.0|-5.6|0.2||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||0.20|-5.60|0.0681
72401399|NCT00362115|144310013|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.6||||0.0004|TWO_SIDED|95.0|-13.28|-3.87||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-3.87|-13.28|0.0004
72401400|NCT00362115|144310013|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.3|||<|0.0001|TWO_SIDED|95.0|-17.26|-7.42||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-7.42|-17.26|< 0.0001
72401401|NCT00362115|144310013|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.6|||<|0.0001|TWO_SIDED|95.0|-16.51|-6.78||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-6.78|-16.51|< 0.0001
72566753|NCT01287039|144664234|SUPERIORITY_OR_OTHER_LEGACY||CAE rate ratio (reslizumab vs placebo)|0.6595||||0.2572|TWO_SIDED|95.0|0.321|1.355||The treatment effect was tested using the likelihood based Chi-square test at the 0.05 significance level.|Chi-squared|||CAE Due to Hospitalization or ER visit The frequency of CAEs was analyzed using the generalized linear model (GLM) for data from the negative binomial distributions that is commonly referred to as the negative binomial (NB) regression model. The primary NB model included the treatment group and randomization stratification factors as model factors and the logarithm of follow up time excluding the summed duration of exacerbations in the treatment period as an offset variable.||1.3550|0.3210|0.2572
72566754|NCT02006628|144664284|SUPERIORITY||Treatment difference (GWP42003-placebo)|-2.8||||0.1332|TWO_SIDED|95.0|-6.5|0.9|||ANCOVA|Change from baseline as the response variable, treatment as fixed effect, and individual baseline subscore and age as covariates.||||0.9|-6.5|0.1332
72401402|NCT00362115|144310013|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.3|||<|0.0001|TWO_SIDED|95.0|-19.38|-9.25||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-9.25|-19.38|< 0.0001
72401403|NCT00362115|144310013|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.6|||<|0.0001|TWO_SIDED|95.0|-17.53|-7.7||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-7.70|-17.53|< 0.0001
72401404|NCT00362115|144310013|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.3||||0.1479|TWO_SIDED|95.0|-1.17|7.72||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||7.72|-1.17|0.1479
72401405|NCT00362115|144310013|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5||||0.8382|TWO_SIDED|95.0|-5.16|4.19||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||4.19|-5.16|0.8382
72401406|NCT00362115|144310013|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2||||0.9317|TWO_SIDED|95.0|-4.42|4.82||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||4.82|-4.42|0.9317
72401407|NCT00362115|144310013|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.5||||0.3169|TWO_SIDED|95.0|-7.29|2.37||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||2.37|-7.29|0.3169
72401408|NCT00362115|144310013|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8||||0.7488|TWO_SIDED|95.0|-5.44|3.91||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||3.91|-5.44|0.7488
72401409|NCT00362115|144310014|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.7|||<|0.0001|TWO_SIDED|95.0|-9.98|-3.4||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-3.40|-9.98|< 0.0001
72401410|NCT00362115|144310014|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.3|||<|0.0001|TWO_SIDED|95.0|-12.76|-5.86||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-5.86|-12.76|< 0.0001
72401411|NCT00362115|144310014|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.6|||<|0.0001|TWO_SIDED|95.0|-12.05|-5.22||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-5.22|-12.05|< 0.0001
72401412|NCT00362115|144310014|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.4|||<|0.0001|TWO_SIDED|95.0|-13.92|-6.79||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-6.79|-13.92|< 0.0001
72401413|NCT00362115|144310014|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.7|||<|0.0001|TWO_SIDED|95.0|-13.11|-6.2||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-6.20|-13.11|< 0.0001
72480831|NCT01620255|144488210|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|0.056||||0.2617|TWO_SIDED|90.0|-0.075|0.186||1-sided p-value|Cochran-Mantel-Haenszel|Statistics of risk difference are calculated using the Minimum Risk Weights test.|Statistics of risk difference are calculated using the Minimum Risk Weights test.|PF-00547659 7.5 mg vs placebo, locally read||0.186|-0.075|0.2617
72480832|NCT01620255|144488210|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|0.212||||0.0058|TWO_SIDED|90.0|0.077|0.347||1-sided p-value|Cochran-Mantel-Haenszel|Statistics of risk difference are calculated using the Minimum Risk Weights test.|Statistics of risk difference are calculated using the Minimum Risk Weights test.|PF-00547659 22.5 mg vs placebo, locally read||0.347|0.077|0.0058
72480833|NCT01620255|144488210|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|0.156||||0.0326|TWO_SIDED|90.0|0.022|0.29||1-sided p-value|Cochran-Mantel-Haenszel|Statistics of risk difference are calculated using the Minimum Risk Weights test.|Statistics of risk difference are calculated using the Minimum Risk Weights test.|PF-00547659 75 mg vs placebo, locally read||0.290|0.022|0.0326
72480834|NCT01620255|144488210|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|0.185||||0.0145|TWO_SIDED|90.0|0.05|0.32||1-sided p-value|Cochran-Mantel-Haenszel|Statistics of risk difference are calculated using the Minimum Risk Weights test.|Statistics of risk difference are calculated using the Minimum Risk Weights test.|PF-00547659 225 mg vs placebo, locally read||0.320|0.050|0.0145
72480835|NCT01620255|144488211|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|0.081||||0.0618|TWO_SIDED|90.0|0.0|0.162||1-sided p-value|Cochran-Mantel-Haenszel|Statistics of risk difference are calculated using the Minimum Risk Weights test.|Statistics of risk difference are calculated using the Minimum Risk Weights test.|PF-00547659 7.5 mg vs placebo, centrally read||0.162|0.000|0.0618
72480836|NCT01620255|144488211|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|0.187||||0.0009|TWO_SIDED|90.0|0.091|0.284||1-sided p-value|Cochran-Mantel-Haenszel|Statistics of risk difference are calculated using the Minimum Risk Weights test.|Statistics of risk difference are calculated using the Minimum Risk Weights test.|PF-00547659 22.5 mg vs placebo, centrally read||0.284|0.091|0.0009
72480837|NCT01620255|144488211|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|0.159||||0.0027|TWO_SIDED|90.0|0.068|0.25||1-sided p-value|Cochran-Mantel-Haenszel|Statistics of risk difference are calculated using the Minimum Risk Weights test.|Statistics of risk difference are calculated using the Minimum Risk Weights test.|PF-00547659 75 mg vs placebo, centrally read||0.250|0.068|0.0027
72480838|NCT01620255|144488211|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|0.069||||0.0999|TWO_SIDED|90.0|-0.013|0.151||1-sided p-value|Cochran-Mantel-Haenszel|Statistics of risk difference are calculated using the Minimum Risk Weights test.|Statistics of risk difference are calculated using the Minimum Risk Weights test.|PF-00547659 225 mg vs placebo, centrally read||0.151|-0.013|0.0999
72510124|NCT00418834|144550877|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-9.5|STANDARD_ERROR_OF_MEAN|1.0|<|0.001||95.0|-11.6|-7.5|||ANCOVA|Model terms: treatment, baseline Apo B:Apo A-I, and AVD status|(Atorva 10 mg + EZ minus Atorva 20 mg)|||-7.5|-11.6|<0.001
72510125|NCT00418834|144550878|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.3|STANDARD_ERROR_OF_MEAN|1.2|<|0.001||95.0|-7.7|-2.9|||ANCOVA|Model terms: treatment, baseline Apo B:Apo A-I, and AVD status|(Atorva 10 mg + EZ minus Atorva 20 mg / Atorva 40 mg)|||-2.9|-7.7|<0.001
72401414|NCT00362115|144310014|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.3||||0.4188|TWO_SIDED|95.0|-1.83|4.4||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||4.40|-1.83|0.4188
72510126|NCT00418834|144550879|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-12.9|STANDARD_ERROR_OF_MEAN|1.2|<|0.001||95.0|-15.3|-10.5|||ANCOVA|Model terms: treatment, baseline non-HDL-C:HDL-C, and AVD status|(Atorva 10 mg + EZ minus Atorva 20 mg)|||-10.5|-15.3|<0.001
72401415|NCT00362115|144310014|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.3||||0.4255|TWO_SIDED|95.0|-4.62|1.95||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||1.95|-4.62|0.4255
72401416|NCT00362115|144310014|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7||||0.6869|TWO_SIDED|95.0|-3.91|2.58||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||2.58|-3.91|0.6869
72480839|NCT01620255|144488211|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|0.001||||0.5225|TWO_SIDED|90.0|-0.111|0.114||1-sided p-value|Cochran-Mantel-Haenszel|Statistics of risk difference are calculated using the Minimum Risk Weights test.|Statistics of risk difference are calculated using the Minimum Risk Weights test.|PF-00547659 7.5 mg vs placebo, locally read||0.114|-0.111|0.5225
72480840|NCT01620255|144488211|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|0.154||||0.0246|TWO_SIDED|90.0|0.03|0.278||1-sided p-value|Cochran-Mantel-Haenszel|Statistics of risk difference are calculated using the Minimum Risk Weights test.|Statistics of risk difference are calculated using the Minimum Risk Weights test.|PF-00547659 22.5 mg vs placebo, locally read||0.278|0.030|0.0246
72480841|NCT01620255|144488211|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|0.13||||0.0464|TWO_SIDED|90.0|0.008|0.253||1-sided p-value|Cochran-Mantel-Haenszel|Statistics of risk difference are calculated using the Minimum Risk Weights test.|Statistics of risk difference are calculated using the Minimum Risk Weights test.|PF-00547659 75 mg vs placebo, locally read||0.253|0.008|0.0464
72480842|NCT01620255|144488211|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|0.066||||0.2|TWO_SIDED|90.0|-0.053|0.186||1-sided p-value|Cochran-Mantel-Haenszel|Statistics of risk difference are calculated using the Minimum Risk Weights test.|Statistics of risk difference are calculated using the Minimum Risk Weights test.|PF-00547659 225 mg vs placebo, locally read||0.186|-0.053|0.2000
72480843|NCT01620255|144488213|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean (LSM) Difference|-0.88||||0.0494|TWO_SIDED|90.0|-1.623|-0.145|||ANCOVA|Analysis of covariance (ANCOVA) with model terms: treatment group, baseline, status of anti-tumor necrosis factor (TNF) therapy experience.||PF-00547659 7.5 mg vs placebo, centrally read change||-0.145|-1.623|0.0494
72480844|NCT01620255|144488213|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-1.53||||0.0005|TWO_SIDED|90.0|-2.254|-0.809|||ANCOVA|Analysis of covariance (ANCOVA) with model terms: treatment group, baseline, status of anti-tumor necrosis factor (TNF) therapy experience.||PF-00547659 22.5 mg vs placebo, centrally read change||-0.809|-2.254|0.0005
72623946|NCT00721110|144778302|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.02||||0.87|TWO_SIDED|97.5|-0.32|0.36||97.5% confidence intervals (CIs) adjusted for group sequential design (using confidence coefficient of 2.97) to maintain the overall α of 0.025 for each intervention and 0.05 for the trial.|Chi-squared||Numinator: ketamine; denominator: nonketamine|Ketamine versus nonketamine on PACU (postoperative care unit) nausea assessed using Pearson chi square test.||0.36|-0.32|0.87
72623947|NCT00721110|144778302|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.06||||0.61|TWO_SIDED|97.5|-0.31|0.44||97.5% confidence intervals (CIs) adjusted for group sequential design (using confidence coefficient of 2.97) to maintain the overall α of 0.025 for each intervention and 0.05 for the trial.|Chi-squared|||Lidocaine versus nonlidocaine on POD 1 (first postoperative day) nausea assessed using Pearson chi square test.||0.44|-0.31|0.61
72623948|NCT00721110|144778302|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.03||||0.79|TWO_SIDED|97.5|-0.34|0.41||97.5% confidence intervals (CIs) adjusted for group sequential design (using confidence coefficient of 2.97) to maintain the overall α of 0.025 for each intervention and 0.05 for the trial.|Chi-squared|||Ketamine versus nonketamine on POD 1(first postoperative day) nausea assessed using Pearson chi square test.||0.41|-0.34|0.79
72401417|NCT00362115|144310014|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.4||||0.1678|TWO_SIDED|95.0|-5.77|1.01||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||1.01|-5.77|0.1678
72623949|NCT00721110|144778302|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|-0.13||||0.26|TWO_SIDED|97.5|-0.38|0.12||97.5% confidence intervals (CIs) adjusted for group sequential design (using confidence coefficient of 2.97) to maintain the overall α of 0.025 for each intervention and 0.05 for the trial.|Chi-squared|||Lidocaine versus nonlidocaine on PACU (postoperative care unit) vomiting assessed using Pearson chi square test.||0.12|-0.38|0.26
72623950|NCT00721110|144778302|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|-0.06||||0.71|TWO_SIDED|97.5|-0.31|0.19||97.5% confidence intervals (CIs) adjusted for group sequential design (using confidence coefficient of 2.97) to maintain the overall α of 0.025 for each intervention and 0.05 for the trial.|Chi-squared|||Ketamine versus nonketamine on PACU (postoperative care unit) vomiting assessed using a Pearson chi square test.||0.19|-0.31|0.71
72480845|NCT01620255|144488213|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-1.12||||0.0117|TWO_SIDED|90.0|-1.845|-0.39|||ANCOVA|Analysis of covariance (ANCOVA) with model terms: treatment group, baseline, status of anti-tumor necrosis factor (TNF) therapy experience.||PF-00547659 75 mg vs placebo, centrally read change||-0.390|-1.845|0.0117
72480846|NCT01620255|144488213|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-1.27||||0.0049|TWO_SIDED|90.0|-2.016|-0.533|||ANCOVA|Analysis of covariance (ANCOVA) with model terms: treatment group, baseline, status of anti-tumor necrosis factor (TNF) therapy experience.||PF-00547659 225 mg vs placebo, centrally read change||-0.533|-2.016|0.0049
72480847|NCT01620255|144488213|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-0.94||||0.0543|TWO_SIDED|90.0|-1.737|-0.137|||ANCOVA|Analysis of covariance (ANCOVA) with model terms: treatment group, baseline, status of anti-tumor necrosis factor (TNF) therapy experience.||PF-00547659 7.5 mg vs placebo, locally read change||-0.137|-1.737|0.0543
72480848|NCT01620255|144488213|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-1.6||||0.0008|TWO_SIDED|90.0|-2.372|-0.819|||ANCOVA|Analysis of covariance (ANCOVA) with model terms: treatment group, baseline, status of anti-tumor necrosis factor (TNF) therapy experience.||PF-00547659 22.5 mg vs placebo, locally read change||-0.819|-2.372|0.0008
72401418|NCT00362115|144310014|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.7||||0.3132|TWO_SIDED|95.0|-4.96|1.6||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||1.60|-4.96|0.3132
72401419|NCT00362115|144310015|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.0||||0.0005|TWO_SIDED|95.0|-12.48|-3.52||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-3.52|-12.48|0.0005
72510127|NCT00418834|144550880|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.7|STANDARD_ERROR_OF_MEAN|1.6|<|0.001||95.0|-9.8|-3.6|||ANCOVA|Model terms: treatment, baseline non-HDL-C:HDL-C, and AVD status|(Atorva 10 mg + EZ minus Atorva 20 mg / Atorva 40 mg)|||-3.6|-9.8|<0.001
72623951|NCT00721110|144778302|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.06||||0.52|TWO_SIDED|97.5|-0.23|0.36||97.5% confidence intervals (CIs) adjusted for group sequential design (using confidence coefficient of 2.97) to maintain the overall α of 0.025 for each intervention and 0.05 for the trial.|Chi-squared|||Lidocaine versus nonlidocaine on postoperative day 1 vomiting assessed using a Pearson chi square test.||0.36|-0.23|0.52
72623952|NCT00721110|144778302|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.07||||0.44|TWO_SIDED|97.5|-0.22|0.38|||Chi-squared|||Ketamine versus nonketamine on postoperative day 1 vomiting assessed using Pearson chi square test.||0.38|-0.22|0.44
72480849|NCT01620255|144488213|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-1.07||||0.0255|TWO_SIDED|90.0|-1.858|-0.284|||ANCOVA|Analysis of covariance (ANCOVA) with model terms: treatment group, baseline, status of anti-tumor necrosis factor (TNF) therapy experience.||PF-00547659 75 mg vs placebo, locally read change||-0.284|-1.858|0.0255
72480850|NCT01620255|144488213|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-1.29||||0.0079|TWO_SIDED|90.0|-2.082|-0.493|||ANCOVA|Analysis of covariance (ANCOVA) with model terms: treatment group, baseline, status of anti-tumor necrosis factor (TNF) therapy experience.||PF-00547659 225 mg vs placebo, locally read change||-0.493|-2.082|0.0079
72480851|NCT01620255|144488214|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-0.25||||0.1016|TWO_SIDED|90.0|-0.511|0.001|||Mixed Models Analysis|Linear Mixed Model (LMM) with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 7.5 mg vs placebo, Stool Frequency, W4||0.001|-0.511|0.1016
72480852|NCT01620255|144488214|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-0.28||||0.0654|TWO_SIDED|90.0|-0.529|-0.03|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 22.5 mg vs placebo, Stool Frequency, W4||-0.030|-0.529|0.0654
72623953|NCT00721110|144778303|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.03||||0.96|TWO_SIDED|97.5|-2.14|2.2||97.5% confidence intervals (CIs) adjusted for group sequential design (using confidence coefficient of 2.97) to maintain the overall α of 0.025 for each intervention and 0.05 for the trial.|t-test, 2 sided|||Lidocaine was compared to nonlidocaine on mean VRS fatigue score using a t test.||2.2|-2.14|0.96
72623954|NCT00721110|144778303|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3||||0.59|TWO_SIDED|97.5|-1.8|2.57||97.5% confidence intervals (CIs) adjusted for group sequential design (using confidence coefficient of 2.97) to maintain the overall α of 0.025 for each intervention and 0.05 for the trial.|t-test, 2 sided|||Ketamine was compared to nonketamine on mean VRS fatigue score using a t test.||2.57|-1.80|0.59
72623955|NCT01554904|144778304|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|162.24|STANDARD_ERROR_OF_MEAN|62.4||0.02|TWO_SIDED|95.0|27.32|297.16|||paired t test|||The null hypothesis is that the snore index would not be different after 6 weeks of treatment compared to baseline. The comparison group is the subjects completing the 6 weeks of training and the second sleep study.||297.16|27.32|0.02
72401420|NCT00362115|144310015|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.6|||<|0.0001|TWO_SIDED|95.0|-15.24|-5.93||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-5.93|-15.24|< 0.0001
72401421|NCT00362115|144310015|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.1|||<|0.0001|TWO_SIDED|95.0|-14.7|-5.44||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-5.44|-14.70|< 0.0001
72401422|NCT00362115|144310015|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.2|||<|0.0001|TWO_SIDED|95.0|-17.95|-8.42||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-8.42|-17.95|< 0.0001
72401423|NCT00362115|144310015|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.1|||<|0.0001|TWO_SIDED|95.0|-16.74|-7.48||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-7.48|-16.74|< 0.0001
72401424|NCT00362115|144310015|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5||||0.8103|TWO_SIDED|95.0|-4.79|3.75||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||3.75|-4.79|0.8103
72401425|NCT00362115|144310015|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.1||||0.1702|TWO_SIDED|95.0|-7.57|1.34||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||1.34|-7.57|0.1702
72401426|NCT00362115|144310015|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.6||||0.2504|TWO_SIDED|95.0|-7.02|1.84||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||1.84|-7.02|0.2504
72401427|NCT00362115|144310015|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.7||||0.0144|TWO_SIDED|95.0|-10.28|-1.14||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-1.14|-10.28|0.0144
72401428|NCT00362115|144310015|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.6||||0.0402|TWO_SIDED|95.0|-9.06|-0.21||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-0.21|-9.06|0.0402
72401429|NCT00362115|144310016|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.2||||0.0014|TWO_SIDED|95.0|-8.41|-2.04||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-2.04|-8.41|0.0014
72401430|NCT00362115|144310016|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.5|||<|0.0001|TWO_SIDED|95.0|-10.82|-4.22||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-4.22|-10.82|< 0.0001
72401431|NCT00362115|144310016|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.2|||<|0.0001|TWO_SIDED|95.0|-11.51|-4.93||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-4.93|-11.51|< 0.0001
72401432|NCT00362115|144310016|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.1|||<|0.0001|TWO_SIDED|95.0|-12.49|-5.72||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-5.72|-12.49|< 0.0001
72401433|NCT00362115|144310016|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.6|||<|0.0001|TWO_SIDED|95.0|-10.87|-4.3||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-4.30|-10.87|< 0.0001
72401434|NCT00362115|144310016|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.9||||0.5519|TWO_SIDED|95.0|-2.11|3.95||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||3.95|-2.11|0.5519
72401435|NCT00362115|144310016|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.4||||0.3938|TWO_SIDED|95.0|-4.54|1.79||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||1.79|-4.54|0.3938
72401436|NCT00362115|144310016|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.1||||0.1949|TWO_SIDED|95.0|-5.21|1.07||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||1.07|-5.21|0.1949
72401437|NCT00362115|144310016|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.0||||0.0732|TWO_SIDED|95.0|-6.21|0.28||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||0.28|-6.21|0.0732
72401438|NCT00362115|144310016|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.4||||0.3669|TWO_SIDED|95.0|-4.59|1.7||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||1.70|-4.59|0.3669
72623956|NCT01554904|144778305|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.85|STANDARD_ERROR_OF_MEAN|0.66||0.22|TWO_SIDED|95.0|-2.28|0.584||paired t test|t-test, 2 sided|||Participants completing 6 weeks of training and the second sleep study. The null hypothesis was that the AHI would not be different after 6 weeks of training compared to baseline.||0.584|-2.28|0.22
72401439|NCT00362115|144310017|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.2||||0.0019|TWO_SIDED|95.0|-14.94|-3.41||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-3.41|-14.94|0.0019
72401440|NCT00362115|144310017|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.2||||0.0008|TWO_SIDED|95.0|-16.15|-4.26||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-4.26|-16.15|0.0008
72401441|NCT00362115|144310017|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.9||||0.004|TWO_SIDED|95.0|-14.88|-2.85||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-2.85|-14.88|0.0040
72401442|NCT00362115|144310017|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.6||||0.0001|TWO_SIDED|95.0|-18.96|-6.22||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-6.22|-18.96|0.0001
72401443|NCT00362115|144310017|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.9||||0.0004|TWO_SIDED|95.0|-16.85|-4.89||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-4.89|-16.85|0.0004
72401444|NCT00362115|144310017|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.7||||0.3499|TWO_SIDED|95.0|-8.39|2.98||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||2.98|-8.39|0.3499
72401445|NCT00362115|144310017|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.7||||0.2115|TWO_SIDED|95.0|-9.61|2.14||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||2.14|-9.61|0.2115
72401446|NCT00362115|144310017|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.4||||0.4279|TWO_SIDED|95.0|-8.34|3.54||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||3.54|-8.34|0.4279
72401447|NCT00362115|144310017|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.1||||0.0566|TWO_SIDED|95.0|-12.41|0.17||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||0.17|-12.41|0.0566
72401448|NCT00362115|144310017|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.4||||0.1435|TWO_SIDED|95.0|-10.3|1.5||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||1.50|-10.30|0.1435
72401449|NCT00362115|144310018|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.7||||0.1162|TWO_SIDED|95.0|-6.16|0.68||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||0.68|-6.16|0.1162
72401450|NCT00362115|144310018|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.1||||0.2494|TWO_SIDED|95.0|-5.69|1.48||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||1.48|-5.69|0.2494
72401451|NCT00362115|144310018|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.4||||0.4247|TWO_SIDED|95.0|-5.01|2.12||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||2.12|-5.01|0.4247
72401452|NCT00362115|144310018|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.0||||0.3007|TWO_SIDED|95.0|-5.79|1.8||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||1.80|-5.79|0.3007
72401453|NCT00362115|144310018|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.0||||0.1195|TWO_SIDED|95.0|-6.67|0.77||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||0.77|-6.67|0.1195
72401454|NCT00362115|144310018|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.3||||0.2032|TWO_SIDED|95.0|-5.76|1.23||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||1.23|-5.76|0.2032
72401455|NCT00362115|144310018|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.6||||0.3787|TWO_SIDED|95.0|-5.27|2.01||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||2.01|-5.27|0.3787
72401456|NCT00362115|144310018|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0||||0.5967|TWO_SIDED|95.0|-4.59|2.64||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||2.64|-4.59|0.5967
72401457|NCT00362115|144310018|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.5||||0.4345|TWO_SIDED|95.0|-5.36|2.31||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||2.31|-5.36|0.4345
72401458|NCT00362115|144310018|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.5||||0.1954|TWO_SIDED|95.0|-6.24|1.28||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||1.28|-6.24|0.1954
72401459|NCT01826487|144310038|OTHER||Mean Difference (Final Values)|12.98|STANDARD_ERROR_OF_MEAN|10.415||0.213|TWO_SIDED|95.0|-7.44|33.39||Threshold for significance at 0.05. Secondary endpoints were tested for significance, only if the primary endpoint was statistically significant.|Mixed Models Analysis|||Analysis was performed using analysis of covariance (ANCOVA) method including stratification factors for age (less than \[\<\] 9 years versus \[vs.\] greater than or equal to \[\>=\] 9 years), duration of use of corticosteroids at baseline (approx. \>=6 to \<12 months vs. \>=12 months), and baseline 6MWD category (\>=350 meters vs \<350 meters), as well as baseline 6MWD as covariate.||33.39|-7.44|0.213
72401460|NCT01408030|144310049|OTHER|Two sided testing was performed with a significance level of 0.05.||||||0.97|||||||ANOVA|||||||0.97
72401461|NCT01408030|144310050|OTHER|Two sided testing was performed with a significance level of 0.05.||||||0.47|||||||ANOVA|||||||.47
72401462|NCT01408030|144310051|OTHER|Two sided testing was performed with a significance level of 0.05.|||||<|0.001||||||"A mixed-model repeated-measures ANOVA was used to analyze ESS for drug and time (baseline, week 12) effects.~Listed P value is for time effect."|Mixed Models Analysis|Clinical site and patient were included in the model as random effects.||||||<0.001
72623957|NCT02038647|144778309|SUPERIORITY||Hazard Ratio (HR)|0.77||||0.113|TWO_SIDED|95.0|0.557|1.067||P-value tests the hypothesis of equal event times in both treatment arms obtained using the Log-rank test stratified by disease subtype as sensitive versus resistant/refractory and the presence of brain metastases.|Log Rank||The stratification factors were: disease subtype as sensitive versus resistant/refractory and the presence of brain metastases (yes or no) with treatment (Alisertib + Paclitaxel vs Placebo + Paclitaxel) as a factor in the model.|||1.067|0.557|0.113
72566755|NCT02006628|144664285|SUPERIORITY||Odds Ratio (OR)|2.62||||0.0896|TWO_SIDED|95.0|0.86|8.0|||Regression, Logistic|Responder (yes/no) is the dependent variable with treatment included as factor and age and baseline P, G, and N scores included as covariates.||||8.00|0.86|0.0896
72566756|NCT02006628|144664286|SUPERIORITY||Treatment difference (GWP42003-placebo)|-1.4||||0.0188|TWO_SIDED|95.0|-2.5|-0.2|||ANCOVA|||||-0.2|-2.5|0.0188
72566757|NCT02006628|144664287|SUPERIORITY||Treatment difference (GWP42003-placebo)|0.0||||0.9647|TWO_SIDED|95.0|-1.3|1.4|||ANCOVA|||||1.4|-1.3|0.9647
72566758|NCT02006628|144664288|SUPERIORITY||Treatment difference (GWP42003-placebo)|-1.3||||0.1963|TWO_SIDED|95.0|-3.2|0.7|||ANCOVA|||||0.7|-3.2|0.1963
72566759|NCT02006628|144664289|SUPERIORITY||Treatment difference (GWP42003-placebo)|-3.5||||0.1167|TWO_SIDED|95.0|-7.9|0.9|||ANCOVA|||||0.9|-7.9|0.1167
72566760|NCT02006628|144664290|SUPERIORITY||Treatment difference (GWP42003-placebo)|-0.3||||0.0443|TWO_SIDED|95.0|-0.5|0.0|||ANCOVA|||||0.0|-0.5|0.0443
72566761|NCT02006628|144664291|SUPERIORITY||Treatment difference (GWP42003-placebo)|-0.5||||0.0182|TWO_SIDED|95.0|-0.8|-0.1|||ANCOVA|||||-0.1|-0.8|0.0182
72401463|NCT01408030|144310052|OTHER|Two sided testing was performed with a significance level of 0.05.||||||0.43|||||||ANCOVA|Adjusted for baseline values and random effect of clinic site.||||||0.43
72566762|NCT02006628|144664292|SUPERIORITY||Treatment difference (GWP42003-placebo)|1.31||||0.0677|TWO_SIDED|95.0|-0.1|2.72|||ANCOVA|||||2.72|-0.10|0.0677
72401464|NCT01408030|144310053|OTHER|Two sided testing was performed with a significance level of 0.05.||||||0.42|||||||Fisher Exact|||||||0.42
72401465|NCT01408030|144310054|OTHER|Two sided testing was performed with a significance level of 0.05.||||||0.08|||||||Fisher Exact|||||||0.08
72401466|NCT04665050|144310080|OTHER|Estimated difference and confidence interval (CI) are calculated based on the Miettinen \& Nurminen method|Difference in percentage|0.0|||||TWO_SIDED|95.0|-12.7|12.7|||||V116 minus PNEUMOVAX™23|Injection Site Erythema||12.7|-12.7|
72566763|NCT00834652|144664293|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
72566764|NCT02493777|144664331|SUPERIORITY||||||<|0.001|||||||Mixed model repeated measures analysis|||||||<0.001
72566765|NCT02493777|144664332|SUPERIORITY||||||<|0.001|||||||Mixed model repeated measures analysis|||||||<0.001
72566766|NCT01642914|144664336|SUPERIORITY_OR_OTHER|||||||0.0054|ONE_SIDED||||||Kolmogorov-Smirnov|Kolmogorov-Smirnov test for equality of distribution||||||0.0054
72566767|NCT01642914|144664336|SUPERIORITY_OR_OTHER|||||||0.0012|ONE_SIDED||||||Kolmogorov-Smirnov|Kolmogorov-Smirnov test for equality of distribution||||||0.0012
72566768|NCT01642914|144664349|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.193||||0.0006|TWO_SIDED|95.0|0.086|0.3||p-Values were obtained from the Cochran-Mantel-Haenszel tests controlling for geographic region, comparing each linaclotide dose versus placebo in a pairwise manner.|Cochran-Mantel-Haenszel|||||.300|.086|0.0006
72566769|NCT01642914|144664349|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.17||||0.0022|TWO_SIDED|95.0|0.064|0.227||p-Values were obtained from the Cochran-Mantel-Haenszel tests controlling for geographic region, comparing each linaclotide dose versus placebo in a pairwise manner.|Cochran-Mantel-Haenszel|||||.227|.064|0.0022
72566770|NCT01642914|144664350|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.37||||0.0054|TWO_SIDED|95.0|1.09|1.72|||Log Rank|Log-rank test stratified by geographic region.||||1.72|1.09|.0054
72566771|NCT01642914|144664350|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.24||||0.047|TWO_SIDED|95.0|0.99|1.55|||Log Rank|Log-rank test stratified by geographic region.||||1.55|0.99|0.0470
72566772|NCT01642914|144664356|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.23||||0.0264|TWO_SIDED|95.0|1.09|4.56||p-values were obtained from the Cochran-Mantel-Haenszel tests controlling for geographic region, comparing each linaclotide dose versus placebo in a pairwise manner.|Cochran-Mantel-Haenszel|||||4.56|1.09|0.0264
72566773|NCT00754442|144664394|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1|TWO_SIDED|95.0||||see above|t-test, 2 sided|95%||The null hypothesis is that there is no statistical difference between patients and controls at baseline||||0.1
72566774|NCT00754442|144664394|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002|TWO_SIDED|95.0|||||t-test, 2 sided|||The null hypothesis is that there is no statistical difference between patients and controls at 4 hours||||0.002
72566775|NCT00754442|144664394|SUPERIORITY_OR_OTHER_LEGACY|||||||0.003||95.0|||||t-test, 2 sided|||The null hypothesis is that there is no statistical difference between patients and controls at 8 hrs||||0.003
72566776|NCT00296491|144664396|SUPERIORITY_OR_OTHER||Mean Difference (Net)|23.2|STANDARD_ERROR_OF_MEAN|5.41|<|0.001||95.0|12.5|33.8|||t-test, 2 sided||Treatment Difference = FSC - MON|||33.8|12.5|<0.001
72623958|NCT02038647|144778311|SUPERIORITY||Cox Proportional Hazard|0.93||||0.714|TWO_SIDED|95.0|0.652|1.341||P-value tests the hypothesis of equal event times in both treatment arms obtained using the Log-rank test stratified by disease subtype as sensitive versus resistant/refractory and the presence of brain metastases.|Log Rank||The stratification factors were: disease subtype as sensitive versus resistant/refractory and the presence of brain metastases (yes or no) with treatment (Alisertib + Paclitaxel vs Placebo + Paclitaxel) as a factor in the model.|||1.341|0.652|0.714
72401467|NCT04665050|144310080|OTHER|Estimated difference and CI are calculated based on the Miettinen \& Nurminen method|Difference in percentage|-11.8|||||TWO_SIDED|95.0|-30.0|7.3|||||V116 minus PNEUMOVAX™23|Injection Site Pain||7.3|-30.0|
72480853|NCT01620255|144488214|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-0.22||||0.15|TWO_SIDED|90.0|-0.472|0.031|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 75 mg vs placebo, Stool Frequency, W4||0.031|-0.472|0.1500
72480854|NCT01620255|144488214|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-0.38||||0.0132|TWO_SIDED|90.0|-0.637|-0.129|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 225 mg vs placebo, Stool Frequency, W4||-0.129|-0.637|0.0132
72480855|NCT01620255|144488214|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-0.3||||0.0526|TWO_SIDED|90.0|-0.555|-0.046|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 7.5 mg vs placebo, Stool Frequency, W8||-0.046|-0.555|0.0526
72480856|NCT01620255|144488214|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-0.31||||0.0422|TWO_SIDED|90.0|-0.554|-0.058|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 22.5 mg vs placebo, Stool Frequency, W8||-0.058|-0.554|0.0422
72480857|NCT01620255|144488214|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-0.39||||0.011|TWO_SIDED|90.0|-0.637|-0.137|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 75 mg vs placebo, Stool Frequency, W8||-0.137|-0.637|0.0110
72480858|NCT01620255|144488214|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-0.5||||0.001|TWO_SIDED|90.0|-0.755|-0.254|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 225 mg vs placebo, Stool Frequency, W8||-0.254|-0.755|0.0010
72480859|NCT01620255|144488214|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-0.22||||0.1611|TWO_SIDED|90.0|-0.475|0.038|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 7.5 mg vs placebo, Stool Frequency, W12||0.038|-0.475|0.1611
72510128|NCT00418834|144550881|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.8||||0.534||95.0|-11.9|6.4|||Longitudinal Data Analysis (LDA)|LDA method of Liang and Zeger with model terms: treatment, time, AVD status, and the interaction of time by treatment|"(Atorva 10 mg + EZ minus Atorva 20 mg)~Data for analysis was transformed by the natural log and the difference in geometric mean % change from BL calculated based on the difference in the back-transformed least squares means."|||6.4|-11.9|0.534
72401468|NCT04665050|144310080|OTHER|Estimated difference and CI are calculated based on the Miettinen \& Nurminen method|Difference in percentage|0.0|||||TWO_SIDED|95.0|-14.1|14.1|||||V116 minus PNEUMOVAX™23|Injection Site Swelling||14.1|-14.1|
72480860|NCT01620255|144488214|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-0.36||||0.0186|TWO_SIDED|90.0|-0.608|-0.108|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 22.5 mg vs placebo, Stool Frequency, W12||-0.108|-0.608|0.0186
72623959|NCT02038647|144778312|SUPERIORITY||Odds Ratio (OR)|0.74||||0.406|TWO_SIDED|95.0|0.35|1.55||Stratification factors were disease subtypes (sensitive versus resistant/refractory), the presence of brain metastases and region.|Weighted Cochran-Mantel-Haenszel test||Logistic regression using ORR as dependent variable, treatment arm as independent variable and disease subtype (sensitive vs resistant/refractory) and presence of brain metastases as stratification factors.|||1.55|0.35|0.406
72480861|NCT01620255|144488214|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-0.21||||0.1647|TWO_SIDED|90.0|-0.465|0.039|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 75 mg vs placebo, Stool Frequency, W12||0.039|-0.465|0.1647
72480862|NCT01620255|144488214|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-0.35||||0.0231|TWO_SIDED|90.0|-0.607|-0.097|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 225 mg vs placebo, Stool Frequency, W12||-0.097|-0.607|0.0231
72480863|NCT01620255|144488214|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-0.46||||0.0002|TWO_SIDED|90.0|-0.658|-0.26|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 7.5 mg vs placebo, Rectal Bleeding, W4||-0.260|-0.658|0.0002
72480864|NCT01620255|144488214|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-0.52|||<|0.0001|TWO_SIDED|90.0|-0.71|-0.322|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 22.5 mg vs placebo, Rectal Bleeding, W4||-0.322|-0.710|<0.0001
72480865|NCT01620255|144488214|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-0.49|||<|0.0001|TWO_SIDED|90.0|-0.686|-0.295|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 75 mg vs placebo, Rectal Bleeding, W4||-0.295|-0.686|<0.0001
72480866|NCT01620255|144488214|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-0.39||||0.0012|TWO_SIDED|90.0|-0.587|-0.192|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 225 mg vs placebo, Rectal Bleeding, W4||-0.192|-0.587|0.0012
72480867|NCT01620255|144488214|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-0.28||||0.0207|TWO_SIDED|90.0|-0.475|-0.081|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 7.5 mg vs placebo, Rectal Bleeding, W8||-0.081|-0.475|0.0207
72401469|NCT04665050|144310081|OTHER|Estimated difference and CI are calculated based on the Miettinen \& Nurminen method|Difference in percentage|3.9|||||TWO_SIDED|95.0|-9.4|17.5|||||V116 minus PNEUMOVAX™23|Fatigue||17.5|-9.4|
72401470|NCT04665050|144310081|OTHER|Estimated difference and CI are calculated based on the Miettinen \& Nurminen method|Difference in percentage|0.0|||||TWO_SIDED|95.0|-9.9|9.9|||||V116 minus PNEUMOVAX™23|Arthralgia||9.9|-9.9|
72401471|NCT04665050|144310081|OTHER|Estimated difference and CI are calculated based on the Miettinen \& Nurminen method|Difference in percentage|-2.0|||||TWO_SIDED|95.0|-17.5|13.6|||||V116 minus PNEUMOVAX™23|Myalgia||13.6|-17.5|
72480868|NCT01620255|144488214|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-0.24||||0.0402|TWO_SIDED|90.0|-0.432|-0.048|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 22.5 mg vs placebo, Rectal Bleeding, W8||-0.048|-0.432|0.0402
72480869|NCT01620255|144488214|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-0.32||||0.0071|TWO_SIDED|90.0|-0.511|-0.124|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 75 mg vs placebo, Rectal Bleeding, W8||-0.124|-0.511|0.0071
72480870|NCT01620255|144488214|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-0.47|||<|0.0001|TWO_SIDED|90.0|-0.664|-0.275|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 225 mg vs placebo, Rectal Bleeding, W8||-0.275|-0.664|<0.0001
72480871|NCT01620255|144488214|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-0.25||||0.0395|TWO_SIDED|90.0|-0.449|-0.05|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 7.5 mg vs placebo, Rectal Bleeding, W12||-0.050|-0.449|0.0395
72480872|NCT01620255|144488214|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-0.32||||0.0073|TWO_SIDED|90.0|-0.511|-0.123|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 22.5 mg vs placebo, Rectal Bleeding, W12||-0.123|-0.511|0.0073
72480873|NCT01620255|144488214|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-0.24||||0.0413|TWO_SIDED|90.0|-0.439|-0.047|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 75 mg vs placebo, Rectal Bleeding, W12||-0.047|-0.439|0.0413
72510129|NCT00418834|144550882|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-7.0||||0.09||95.0|-15.6|1.6|||Longitudinal Data Analysis (LDA)|LDA method of Liang and Zeger with model terms: treatment, time, AVD status, and the interaction of time by treatment|"(Atorva 10 mg + EZ minus Atorva 20 mg / Atorva 40 mg)~Data for analysis was transformed by the natural log and the difference in geometric mean % change from BL calculated based on the difference in the back-transformed least squares means."|||1.6|-15.6|0.090
72510130|NCT01953328|144550883|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-73.97|STANDARD_ERROR_OF_MEAN|2.3|<|0.001|TWO_SIDED|95.0|-78.54|-69.41||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|The null hypothesis was that there was no difference in the percent change from baseline at the mean of Weeks 10 and 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.||-69.41|-78.54|<0.001
72480874|NCT01620255|144488214|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-0.4||||0.0008|TWO_SIDED|90.0|-0.602|-0.206|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 225 mg vs placebo, Rectal Bleeding, W12||-0.206|-0.602|0.0008
72510131|NCT01953328|144550883|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-72.89|STANDARD_ERROR_OF_MEAN|2.18|<|0.001|TWO_SIDED|95.0|-77.22|-68.57||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|The null hypothesis was that there was no difference in the percent change from baseline at the mean of Weeks 10 and 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.||-68.57|-77.22|<0.001
72510132|NCT01953328|144550883|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-74.41|STANDARD_ERROR_OF_MEAN|3.43|<|0.001|TWO_SIDED|95.0|-81.21|-67.61||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|The null hypothesis was that there was no difference in the percent change from baseline at the mean of Weeks 10 and 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.||-67.61|-81.21|<0.001
72401472|NCT04665050|144310081|OTHER|Estimated difference and CI are calculated based on the Miettinen \& Nurminen method|Difference in percentage|0.0|||||TWO_SIDED|95.0|-12.7|12.7|||||V116 minus PNEUMOVAX™23|Headache||12.7|-12.7|
72401473|NCT04665050|144310082|OTHER|Estimated difference and CI are calculated based on the Miettinen \& Nurminen method|Difference in percentage|0.0|||||TWO_SIDED|95.0|-7.1|7.1|||||V116 minus PNEUMOVAX™23|||7.1|-7.1|
72401474|NCT04665050|144310083|OTHER|GMT ratio and 95% confidence interval CI are estimated from a cLDA model.|GMT Ratio|1.6|||||TWO_SIDED|95.0|1.07|2.4|||||V116/PNEUMOVAX™23|Serotype 3||2.40|1.07|
72401475|NCT04665050|144310083|OTHER|GMT ratio and 95% confidence interval CI are estimated from a cLDA model.|GMT Ratio|1.21|||||TWO_SIDED|95.0|0.69|2.11|||||V116/PNEUMOVAX™23|Serotype 7F||2.11|0.69|
72401476|NCT04665050|144310083|OTHER|GMT ratio and 95% confidence interval CI are estimated from a cLDA model.|GMT Ratio|2.0|||||TWO_SIDED|95.0|1.24|3.24|||||V116/PNEUMOVAX™23|Serotype 19A||3.24|1.24|
72401477|NCT04665050|144310083|OTHER|GMT ratio and 95% confidence interval CI are estimated from a cLDA model.|GMT Ratio|1.92|||||TWO_SIDED|95.0|1.04|3.57|||||V116/PNEUMOVAX™23|Serotype 22F||3.57|1.04|
72401478|NCT04665050|144310083|OTHER|GMT ratio and 95% confidence interval CI are estimated from a cLDA model.|GMT Ratio|1.15|||||TWO_SIDED|95.0|0.71|1.86|||||V116/PNEUMOVAX™23|Serotype 33F||1.86|0.71|
72401479|NCT04665050|144310083|OTHER|GMT ratio and 95% confidence interval CI are estimated from a cLDA model.|GMT Ratio|1.78|||||TWO_SIDED|95.0|1.24|2.58|||||V116/PNEUMOVAX™23|Serotype 8||2.58|1.24|
72480875|NCT01620255|144488214|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-0.19||||0.1862|TWO_SIDED|90.0|-0.421|0.046|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 7.5 mg vs placebo, PGA, W4||0.046|-0.421|0.1862
72480876|NCT01620255|144488214|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-0.23||||0.0998|TWO_SIDED|90.0|-0.455|0.0|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 22.5 mg vs placebo, PGA, W4||-0.000|-0.455|0.0998
72480877|NCT01620255|144488214|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-0.22||||0.1085|TWO_SIDED|90.0|-0.453|0.006|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 75 mg vs placebo, PGA, W4||0.006|-0.453|0.1085
72480878|NCT01620255|144488214|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-0.14||||0.3161|TWO_SIDED|90.0|-0.372|0.09|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 225 mg vs placebo, PGA, W4||0.090|-0.372|0.3161
72480879|NCT01620255|144488214|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-0.1||||0.4962|TWO_SIDED|90.0|-0.328|0.136|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 7.5 mg vs placebo, PGA, W8||0.136|-0.328|0.4962
72401480|NCT04665050|144310083|OTHER|GMT ratio and 95% confidence interval CI are estimated from a cLDA model.|GMT Ratio|1.89|||||TWO_SIDED|95.0|1.19|3.0|||||V116/PNEUMOVAX™23|Serotype 9N||3.00|1.19|
72401481|NCT04665050|144310083|OTHER|GMT ratio and 95% confidence interval CI are estimated from a cLDA model.|GMT Ratio|2.71|||||TWO_SIDED|95.0|1.47|5.0|||||V116/PNEUMOVAX™23|Serotype 10A||5.00|1.47|
72401482|NCT04665050|144310083|OTHER|GMT ratio and 95% confidence interval CI are estimated from a cLDA model.|GMT Ratio|2.43|||||TWO_SIDED|95.0|1.52|3.89|||||V116/PNEUMOVAX™23|Serotype 11A||3.89|1.52|
72401483|NCT04665050|144310083|OTHER|GMT ratio and 95% confidence interval CI are estimated from a cLDA model.|GMT Ratio|2.4|||||TWO_SIDED|95.0|1.2|4.83|||||V116/PNEUMOVAX™23|Serotype 12F||4.83|1.20|
72480880|NCT01620255|144488214|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-0.29||||0.0371|TWO_SIDED|90.0|-0.512|-0.06|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 22.5 mg vs placebo, PGA, W8||-0.060|-0.512|0.0371
72480881|NCT01620255|144488214|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-0.21||||0.1212|TWO_SIDED|90.0|-0.441|0.013|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 75 mg vs placebo, PGA, W8||0.013|-0.441|0.1212
72566777|NCT00296491|144664397|NON_INFERIORITY_OR_EQUIVALENCE|Given estimates, and assuming a significance level of a=0.05, a sample size of 133 subjects per treatment was determined to be sufficient to provide 80% power to show equivalance.|Mean Difference (Net)|-8.9|STANDARD_ERROR_OF_MEAN|8.0|<|0.127||95.0|-24.6|6.9|||t-test, 2 sided||Treatment Difference=FSC+MON-FSC|||6.9|-24.6|<0.127
72401484|NCT04665050|144310083|OTHER|GMT ratio and 95% confidence interval CI are estimated from a cLDA model.|GMT Ratio|2.57|||||TWO_SIDED|95.0|1.59|4.17|||||V116/PNEUMOVAX™23|Serotype 17F||4.17|1.59|
72401485|NCT04665050|144310083|OTHER|GMT ratio and 95% confidence interval CI are estimated from a cLDA model.|GMT Ratio|2.28|||||TWO_SIDED|95.0|1.46|3.56|||||V116/PNEUMOVAX™23|Serotype 20A||3.56|1.46|
72401486|NCT04665050|144310084|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|1.54|||||TWO_SIDED|95.0|1.08|2.21|||||V116/PNEUMOVAX™23|Serotype 3||2.21|1.08|
72401487|NCT04665050|144310084|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|2.21|||||TWO_SIDED|95.0|1.36|3.6|||||V116/PNEUMOVAX™23|Serotype 7F||3.60|1.36|
72401488|NCT04665050|144310084|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|2.16|||||TWO_SIDED|95.0|1.45|3.23|||||V116/PNEUMOVAX™23|Serotype 19A||3.23|1.45|
72401489|NCT04665050|144310084|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|2.33|||||TWO_SIDED|95.0|1.36|3.99|||||V116/PNEUMOVAX™23|Serotype 22F||3.99|1.36|
72401490|NCT04665050|144310084|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|1.52|||||TWO_SIDED|95.0|0.97|2.37|||||V116/PNEUMOVAX™23|Serotype 33F||2.37|0.97|
72401491|NCT04665050|144310084|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|1.88|||||TWO_SIDED|95.0|1.32|2.68|||||V116/PNEUMOVAX™23|Serotype 8||2.68|1.32|
72401492|NCT04665050|144310084|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|2.37|||||TWO_SIDED|95.0|1.49|3.74|||||V116/PNEUMOVAX™23|Serotype 9N||3.74|1.49|
72401493|NCT04665050|144310084|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|2.16|||||TWO_SIDED|95.0|1.28|3.65|||||V116/PNEUMOVAX™23|Serotype 10A||3.65|1.28|
72401494|NCT04665050|144310084|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|1.92|||||TWO_SIDED|95.0|1.28|2.89|||||V116/PNEUMOVAX™23|Serotype 11A||2.89|1.28|
72401495|NCT04665050|144310084|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|3.49|||||TWO_SIDED|95.0|1.94|6.27|||||V116/PNEUMOVAX™23|Serotype 12F||6.27|1.94|
72480882|NCT01620255|144488214|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-0.18||||0.187|TWO_SIDED|90.0|-0.41|0.045|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 225 mg vs placebo, PGA, W8||0.045|-0.410|0.1870
72480883|NCT01620255|144488214|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-0.23||||0.1133|TWO_SIDED|90.0|-0.459|0.009|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 7.5 mg vs placebo, PGA, W12||0.009|-0.459|0.1133
72480884|NCT01620255|144488214|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-0.43||||0.0022|TWO_SIDED|90.0|-0.653|-0.198|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 22.5 mg vs placebo, PGA, W12||-0.198|-0.653|0.0022
72480885|NCT01620255|144488214|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-0.25||||0.0788|TWO_SIDED|90.0|-0.475|-0.016|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 75 mg vs placebo, PGA, W12||-0.016|-0.475|0.0788
72480886|NCT01620255|144488214|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-0.25||||0.0717|TWO_SIDED|90.0|-0.485|-0.022|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 225 mg vs placebo, PGA, W12||-0.022|-0.485|0.0717
72480887|NCT01620255|144488215|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-0.08||||0.5406|TWO_SIDED|90.0|-0.286|0.131|||ANCOVA|ANCOVA with model terms: treatment group, baseline, status of anti-TNF therapy experience.||PF-00547659 7.5 mg vs placebo||0.131|-0.286|0.5406
72401496|NCT04665050|144310084|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|2.88|||||TWO_SIDED|95.0|1.92|4.31|||||V116/PNEUMOVAX™23|Serotype 17F||4.31|1.92|
72401497|NCT04665050|144310084|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|2.05|||||TWO_SIDED|95.0|1.3|3.25|||||V116/PNEUMOVAX™23|Serotype 20A||3.25|1.30|
72401498|NCT04665050|144310085|OTHER|GMT ratio and 95% CI are estimated from a cLDA model.|GMT Ratio|3.58|||||TWO_SIDED|95.0|1.86|6.88|||||V116/PNEUMOVAX™23|Serotype 6A||6.88|1.86|
72401499|NCT04665050|144310085|OTHER|GMT ratio and 95% CI are estimated from a cLDA model.|GMT Ratio|6.23|||||TWO_SIDED|95.0|3.54|10.98|||||V116/PNEUMOVAX™23|Serotype 15A||10.98|3.54|
72401500|NCT04665050|144310085|OTHER|GMT ratio and 95% CI are estimated from a cLDA model.|GMT Ratio|2.33|||||TWO_SIDED|95.0|1.23|4.39|||||V116/PNEUMOVAX™23|Serotype 15C||4.39|1.23|
72401501|NCT04665050|144310085|OTHER|GMT ratio and 95% CI are estimated from a cLDA model.|GMT Ratio|10.06|||||TWO_SIDED|95.0|5.39|18.78|||||V116/PNEUMOVAX™23|Serotype 16F||18.78|5.39|
72480888|NCT01620255|144488215|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-0.42||||0.0007|TWO_SIDED|90.0|-0.628|-0.221|||ANCOVA|ANCOVA with model terms: treatment group, baseline, status of anti-TNF therapy experience.||PF-00547659 22.5 mg vs placebo||-0.221|-0.628|0.0007
72480889|NCT01620255|144488215|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-0.34||||0.0063|TWO_SIDED|90.0|-0.549|-0.137|||ANCOVA|ANCOVA with model terms: treatment group, baseline, status of anti-TNF therapy experience.||PF-00547659 75 mg vs placebo||-0.137|-0.549|0.0063
72401502|NCT04665050|144310085|OTHER|GMT ratio and 95% CI are estimated from a cLDA model.|GMT Ratio|42.09|||||TWO_SIDED|95.0|19.67|90.03|||||V116/PNEUMOVAX™23|Serotype 23A||90.03|19.67|
72401503|NCT04665050|144310085|OTHER|GMT ratio and 95% CI are estimated from a cLDA model.|GMT Ratio|12.37|||||TWO_SIDED|95.0|6.97|21.94|||||V116/PNEUMOVAX™23|Serotype 23B||21.94|6.97|
72401504|NCT04665050|144310085|OTHER|GMT ratio and 95% CI are estimated from a cLDA model.|GMT Ratio|24.82|||||TWO_SIDED|95.0|11.65|52.86|||||V116/PNEUMOVAX™23|Serotype 24F||52.86|11.65|
72401505|NCT04665050|144310085|OTHER|GMT ratio and 95% CI are estimated from a cLDA model.|GMT Ratio|25.66|||||TWO_SIDED|95.0|14.65|44.93|||||V116/PNEUMOVAX™23|Serotype 31||44.93|14.65|
72401506|NCT04665050|144310085|OTHER|GMT ratio and 95% CI are estimated from a cLDA model.|GMT Ratio|14.3|||||TWO_SIDED|95.0|8.72|23.47|||||V116/PNEUMOVAX™23|Serotype 35B||23.47|8.72|
72401507|NCT04665050|144310086|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|3.0|||||TWO_SIDED|95.0|1.73|5.19|||||V116/PNEUMOVAX™23|Serotype 6A||5.19|1.73|
72401508|NCT04665050|144310086|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|8.03|||||TWO_SIDED|95.0|4.61|13.98|||||V116/PNEUMOVAX™23|Serotype 15A||13.98|4.61|
72401509|NCT04665050|144310086|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|3.14|||||TWO_SIDED|95.0|1.77|5.58|||||V116/PNEUMOVAX™23|Serotype 15C||5.58|1.77|
72401510|NCT04665050|144310086|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|13.06|||||TWO_SIDED|95.0|8.45|20.19|||||V116/PNEUMOVAX™23|Serotype 16F||20.19|8.45|
72401511|NCT04665050|144310086|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|8.55|||||TWO_SIDED|95.0|5.19|14.09|||||V116/PNEUMOVAX™23|Serotype 23A||14.09|5.19|
72401512|NCT04665050|144310086|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|4.15|||||TWO_SIDED|95.0|2.72|6.36|||||V116/PNEUMOVAX™23|Serotype 23B||6.36|2.72|
72401513|NCT04665050|144310086|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|28.68|||||TWO_SIDED|95.0|16.59|49.58|||||V116/PNEUMOVAX™23|Serotype 24F||49.58|16.59|
72401514|NCT04665050|144310086|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|10.27|||||TWO_SIDED|95.0|6.71|15.73|||||V116/PNEUMOVAX™23|Serotype 31||15.73|6.71|
72401515|NCT04665050|144310086|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|15.95|||||TWO_SIDED|95.0|11.62|21.9|||||V116/PNEUMOVAX™23|Serotype 35B||21.90|11.62|
72401516|NCT02867709|144310090|SUPERIORITY||Odds Ratio (OR)|1.56||||0.0285|TWO_SIDED|95.0|1.09|2.22||P-value was adjusted for multiple comparisons across primary and secondary endpoints and multiple doses.|Regression, Logistic|Treatment group, historical triptan response, medication use for migraine prevention, baseline headache severity were explanatory variables in model.||||2.22|1.09|0.0285
72401517|NCT02867709|144310090|SUPERIORITY||Odds Ratio (OR)|1.62||||0.0129|TWO_SIDED|95.0|1.14|2.29||P-value was adjusted for multiple comparisons across primary and secondary endpoints and multiple doses.|Regression, Logistic|Treatment group, historical triptan response, medication use for migraine prevention, baseline headache severity were explanatory variables in model.||||2.29|1.14|0.0129
72401518|NCT02867709|144310091|SUPERIORITY||Odds Ratio (OR)|1.37||||0.0711|TWO_SIDED|95.0|1.02|1.83||P-value was adjusted for multiple comparisons across primary and secondary endpoints and multiple doses.|Regression, Logistic|Treatment group, historical triptan response, migraine prevention medication, baseline headache severity, underlying symptom as explanatory variables.||||1.83|1.02|0.0711
72480890|NCT01620255|144488215|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-0.23||||0.0748|TWO_SIDED|90.0|-0.436|-0.018|||ANCOVA|ANCOVA with model terms: treatment group, baseline, status of anti-TNF therapy experience.||PF-00547659 225 mg vs placebo||-0.018|-0.436|0.0748
72480891|NCT01620255|144488216|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-1.9||||0.9744|TWO_SIDED|90.0|-101.0|97.14|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 7.5 mg vs placebo, Week 4||97.14|-101.00|0.9744
72480892|NCT01620255|144488216|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|74.9||||0.2023|TWO_SIDED|90.0|-21.77|171.66|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 22.5 mg vs placebo, Week 4||171.66|-21.77|0.2023
72480893|NCT01620255|144488216|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|32.9||||0.5808|TWO_SIDED|90.0|-65.09|130.79|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 75 mg vs placebo, Week 4||130.79|-65.09|0.5808
72480894|NCT01620255|144488216|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|37.6||||0.5388|TWO_SIDED|90.0|-63.12|138.34|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 225 mg vs placebo, Week 4||138.34|-63.12|0.5388
72401519|NCT02867709|144310091|SUPERIORITY||Odds Ratio (OR)|1.65||||0.0129|TWO_SIDED|95.0|1.25|2.2||P-value was adjusted for multiple comparisons across primary and secondary endpoints and multiple doses.|Regression, Logistic|Treatment group, historical triptan response, migraine prevention medication, baseline headache severity, underlying symptom as explanatory variables.||||2.20|1.25|0.0129
72401520|NCT02867709|144310092|SUPERIORITY||Odds Ratio (OR)|1.65||||0.0711|TWO_SIDED|95.0|1.25|2.17||P-value was adjusted for multiple comparisons across primary and secondary endpoints and multiple doses.|Regression, Logistic|Treatment group, historical triptan response, medication use for migraine prevention, baseline headache severity were explanatory variables in model.||||2.17|1.25|0.0711
72401521|NCT02867709|144310092|SUPERIORITY||Odds Ratio (OR)|1.77||||0.0129|TWO_SIDED|95.0|1.35|2.32||P-value was adjusted for multiple comparisons across primary and secondary endpoints and multiple doses.|Regression, Logistic|Treatment group, historical triptan response, medication use for migraine prevention, baseline headache severity were explanatory variables in model.||||2.32|1.35|0.0129
72401522|NCT02867709|144310093|SUPERIORITY||Odds Ratio (OR)|1.82||||0.0711|TWO_SIDED|95.0|1.33|2.48||P-value was adjusted for multiple comparisons across primary and secondary endpoints and multiple doses.|Regression, Logistic|Treatment group, historical triptan response, medication use for migraine prevention, baseline headache severity were explanatory variables in model.||||2.48|1.33|0.0711
72480895|NCT01620255|144488216|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-8.2||||0.8902|TWO_SIDED|90.0|-106.24|89.81|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 7.5 mg vs placebo, Week 8||89.81|-106.24|0.8902
72401523|NCT02867709|144310093|SUPERIORITY||Odds Ratio (OR)|2.16||||0.0129|TWO_SIDED|95.0|1.59|2.92||P-value was adjusted for multiple comparisons across primary and secondary endpoints and multiple doses.|Regression, Logistic|Treatment group, historical triptan response, medication use for migraine prevention, baseline headache severity were explanatory variables in model.||||2.92|1.59|0.0129
72480896|NCT01620255|144488216|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|10.2||||0.8616|TWO_SIDED|90.0|-86.14|106.54|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 22.5 mg vs placebo, Week 8||106.54|-86.14|0.8616
72480897|NCT01620255|144488216|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-34.3||||0.5684|TWO_SIDED|90.0|-133.49|64.79|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 75 mg vs placebo, Week 8||64.79|-133.49|0.5684
72480898|NCT01620255|144488216|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|33.8||||0.57|TWO_SIDED|90.0|-64.2|131.86|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 225 mg vs placebo, Week 8||131.86|-64.20|0.5700
72401524|NCT02867709|144310094|SUPERIORITY||Odds Ratio (OR)|1.62||||0.0711|TWO_SIDED|95.0|1.04|2.53||P-value was adjusted for multiple comparisons across primary and secondary endpoints and multiple doses.|Regression, Logistic|Treatment group, historical triptan response, medication use for migraine prevention, baseline headache severity were explanatory variables in model.||||2.53|1.04|0.0711
72480899|NCT01620255|144488216|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-30.0||||0.6234|TWO_SIDED|90.0|-130.56|70.57|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 7.5 mg vs placebo, Week 12||70.57|-130.56|0.6234
72401525|NCT02867709|144310094|SUPERIORITY||Odds Ratio (OR)|1.85||||0.0129|TWO_SIDED|95.0|1.2|2.83||P-value was adjusted for multiple comparisons across primary and secondary endpoints and multiple doses.|Regression, Logistic|Treatment group, historical triptan response, medication use for migraine prevention, baseline headache severity were explanatory variables in model.||||2.83|1.20|0.0129
72401526|NCT02867709|144310095|SUPERIORITY||Odds Ratio (OR)|1.28||||0.1833|TWO_SIDED|95.0|0.96|1.72||P-value was adjusted for multiple comparisons across primary and secondary endpoints and multiple doses.|Regression, Logistic|Treatment group, historical triptan response, migraine prevention medication, baseline headache severity, photophobia were explanatory variables.||||1.72|0.96|0.1833
72480900|NCT01620255|144488216|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|36.0||||0.5474|TWO_SIDED|90.0|-62.44|134.38|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 22.5 mg vs placebo, Week 12||134.38|-62.44|0.5474
72480901|NCT01620255|144488216|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|78.5||||0.1918|TWO_SIDED|90.0|-20.48|177.56|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 75 mg vs placebo,Week 12||177.56|-20.48|0.1918
72480902|NCT01620255|144488216|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-3.0||||0.9615|TWO_SIDED|90.0|-104.88|98.91|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 225 mg vs placebo, Week 12||98.91|-104.88|0.9615
72480903|NCT01620255|144488217|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|6.4||||0.9328|TWO_SIDED|90.0|-118.6|131.41|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 7.5 mg vs placebo, Week 4||131.41|-118.60|0.9328
72401527|NCT02867709|144310095|SUPERIORITY||Odds Ratio (OR)|1.52||||0.0167|TWO_SIDED|95.0|1.14|2.02||P-value was adjusted for multiple comparisons across primary and secondary endpoints and multiple doses.|Regression, Logistic|Treatment group, historical triptan response, migraine prevention medication, baseline headache severity, photophobia were explanatory variables.||||2.02|1.14|0.0167
72480904|NCT01620255|144488217|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-9.8||||0.8962|TWO_SIDED|90.0|-132.91|113.39|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 22.5 mg vs placebo, Week 4||113.39|-132.91|0.8962
72480905|NCT01620255|144488217|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|11.5||||0.8775|TWO_SIDED|90.0|-110.83|133.74|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 75 mg vs placebo, Week 4||133.74|-110.83|0.8775
72480906|NCT01620255|144488217|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-17.0||||0.8224|TWO_SIDED|90.0|-142.02|107.94|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 225 mg vs placebo, Week 4||107.94|-142.02|0.8224
72401528|NCT02867709|144310096|SUPERIORITY||Odds Ratio (OR)|1.38||||0.1066|TWO_SIDED|95.0|1.04|1.83||P-value was adjusted for multiple comparisons across primary and secondary endpoints and multiple doses.|Regression, Logistic|Treatment group, historical triptan response, migraine prevention medication, baseline headache severity, phonophobia were explanatory variables.||||1.83|1.04|0.1066
72480907|NCT01620255|144488217|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-52.7||||0.4831|TWO_SIDED|90.0|-176.48|71.02|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 7.5 mg vs placebo, Week 8||71.02|-176.48|0.4831
72480908|NCT01620255|144488217|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-115.2||||0.1183|TWO_SIDED|90.0|-236.63|6.13|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 22.5 mg vs placebo, Week 8||6.13|-236.63|0.1183
72480909|NCT01620255|144488217|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-115.8||||0.1139|TWO_SIDED|90.0|-236.29|4.69|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 75 mg vs placebo, Week 8||4.69|-236.29|0.1139
72480910|NCT01620255|144488217|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-96.4||||0.1931|TWO_SIDED|90.0|-218.17|25.46|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 225 mg vs placebo, Week 8||25.46|-218.17|0.1931
72480911|NCT01620255|144488217|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-119.7||||0.1182|TWO_SIDED|90.0|-245.66|6.32|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 7.5 mg vs placebo, Week 12||6.32|-245.66|0.1182
72480912|NCT01620255|144488217|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-41.7||||0.5784|TWO_SIDED|90.0|-165.34|81.87|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 22.5 mg vs placebo, Week 12||81.87|-165.34|0.5784
72480913|NCT01620255|144488217|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-163.6||||0.0279|TWO_SIDED|90.0|-285.84|-41.29|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 75 mg vs placebo,Week 12||-41.29|-285.84|0.0279
72480914|NCT01620255|144488217|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-123.5||||0.1053|TWO_SIDED|90.0|-249.0|1.93|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 225 mg vs placebo, Week 12||1.93|-249.00|0.1053
72480915|NCT01620255|144488218|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-1.1||||0.8302|TWO_SIDED|90.0|-9.507|7.317|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 7.5 mg vs placebo, change from BL at W12||7.317|-9.507|0.8302
72480916|NCT01620255|144488218|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|12.33||||0.0141|TWO_SIDED|90.0|4.084|20.567|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 22.5 mg vs placebo, change from BL at W12||20.567|4.084|0.0141
72480917|NCT01620255|144488218|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|11.7||||0.0182|TWO_SIDED|90.0|3.564|19.84|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 75 mg vs placebo, change from BL at W12||19.840|3.564|0.0182
72480918|NCT01620255|144488218|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|15.48||||0.0026|TWO_SIDED|90.0|7.056|23.907|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 225 mg vs placebo, change from BL at W12||23.907|7.056|0.0026
72480919|NCT01620255|144488219|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-0.73||||0.6862|TWO_SIDED|90.0|-3.689|2.235|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 7.5 mg vs placebo, bowel fx change from BL at W12||2.235|-3.689|0.6862
72480920|NCT01620255|144488219|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|4.37||||0.0135|TWO_SIDED|90.0|1.467|7.28|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 22.5 mg vs placebo, bowel fx change from BL at W12||7.280|1.467|0.0135
72480921|NCT01620255|144488219|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|4.16||||0.0171|TWO_SIDED|90.0|1.293|7.023|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 75 mg vs placebo, bowel fx change from BL at W12||7.023|1.293|0.0171
72401529|NCT02867709|144310096|SUPERIORITY||Odds Ratio (OR)|1.39||||0.044|TWO_SIDED|95.0|1.05|1.84||P-value was adjusted for multiple comparisons across primary and secondary endpoints and multiple doses.|Regression, Logistic|Treatment group, historical triptan response, migraine prevention medication, baseline headache severity, phonophobia were explanatory variables.||||1.84|1.05|0.0440
72480922|NCT01620255|144488219|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|5.2||||0.0041|TWO_SIDED|90.0|2.232|8.172|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 225 mg vs placebo, bowel fx change from BL at W12||8.172|2.232|0.0041
72480923|NCT01620255|144488219|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|0.22||||0.9072|TWO_SIDED|90.0|-2.897|3.339|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 7.5 mg vs placebo, emotional fx change from BL at W12||3.339|-2.897|0.9072
72480924|NCT01620255|144488219|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|4.47||||0.0161|TWO_SIDED|90.0|1.42|7.522|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 22.5 mg vs placebo, emotional fx change from BL at W12||7.522|1.420|0.0161
72480925|NCT01620255|144488219|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|4.06||||0.0271|TWO_SIDED|90.0|1.042|7.071|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 75 mg vs placebo, emotional fx change from BL at W12||7.071|1.042|0.0271
72401530|NCT02867709|144310097|SUPERIORITY||Odds Ratio (OR)|1.1||||0.9522|TWO_SIDED|95.0|0.81|1.49||P-value was adjusted for multiple comparisons across primary and secondary endpoints and multiple doses.|Regression, Logistic|Treatment group, historical triptan response, migraine prevention medication, baseline headache severity, nausea were explanatory variables.||||1.49|0.81|0.9522
72401531|NCT02867709|144310097|SUPERIORITY||Odds Ratio (OR)|1.12||||0.9522|TWO_SIDED|95.0|0.83|1.51||P-value was adjusted for multiple comparisons across primary and secondary endpoints and multiple doses.|Regression, Logistic|Treatment group, historical triptan response, migraine prevention medication, baseline headache severity, nausea were explanatory variables.||||1.51|0.83|0.9522
72401532|NCT06002958|144310099|OTHER||Cohen's d|-0.29|||||TWO_SIDED|95.0|-0.815|0.255|||||Inner|||0.255|-0.815|
72480926|NCT01620255|144488219|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|5.9||||0.002|TWO_SIDED|90.0|2.778|9.026|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 225 mg vs placebo, emotional fx change from BL at W12||9.026|2.778|0.0020
72401533|NCT06002958|144310099|OTHER||Cohen's d|0.02|||||TWO_SIDED|95.0|-0.503|0.545|||||Outer|||0.545|-0.503|
72480927|NCT01620255|144488219|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-0.26||||0.7711|TWO_SIDED|90.0|-1.756|1.229|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 7.5 mg vs placebo, systemic symptoms change from BL at W12||1.229|-1.756|0.7711
72480928|NCT01620255|144488219|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|1.69||||0.0582|TWO_SIDED|90.0|0.223|3.147|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 22.5 mg vs placebo, systemic symptoms change from BL at W12||3.147|0.223|0.0582
72480929|NCT01620255|144488219|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|1.68||||0.0558|TWO_SIDED|90.0|0.235|3.12|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 75 mg vs placebo, systemic symptoms change from BL at W12||3.120|0.235|0.0558
72480930|NCT01620255|144488219|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|1.66||||0.0686|TWO_SIDED|90.0|0.161|3.153|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 225 mg vs placebo, systemic symptoms change from BL at W12||3.153|0.161|0.0686
72480931|NCT01620255|144488219|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-0.33||||0.7561|TWO_SIDED|90.0|-2.094|1.429|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 7.5 mg vs placebo, social fx change from BL at W12||1.429|-2.094|0.7561
72401534|NCT06002958|144310099|OTHER||Cohen's d|-0.32|||||TWO_SIDED|95.0|-0.85|0.225|||||Individual|||0.225|-0.850|
72401535|NCT06002958|144310099|OTHER||Cohen's d|0.01|||||TWO_SIDED|95.0|-0.85|0.534|||||Process|||0.534|-0.850|
72401536|NCT05214768|144310107|SUPERIORITY||Least Square Mean Difference|-223.2|STANDARD_ERROR_OF_MEAN|74.98||0.003|TWO_SIDED|95.0|-370.2|-76.3|||ANCOVA|||||-76.3|-370.2|0.003
72401537|NCT04303780|144310159|EQUIVALENCE|A hazard ratio \<1.0 indicates a lower average event rate and a longer PFS for AMG 510 relative to docetaxel. P-value was calculated using a stratified log-rank test.|Hazard Ratio (HR)|0.663||||0.002|TWO_SIDED|95.0|0.509|0.864|||Log Rank|||||0.864|0.509|0.002
72480932|NCT01620255|144488219|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|2.17||||0.0384|TWO_SIDED|90.0|0.447|3.891|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 22.5 mg vs placebo, social fx change from BL at W12||3.891|0.447|0.0384
72480933|NCT01620255|144488219|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|1.86||||0.0729|TWO_SIDED|90.0|0.154|3.557|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 75 mg vs placebo, social fx change from BL at W12||3.557|0.154|0.0729
72480934|NCT01620255|144488219|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|2.95||||0.006|TWO_SIDED|90.0|1.19|4.715|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 225 mg vs placebo, social fx change from BL at W12||4.715|1.190|0.0060
72480935|NCT01620255|144488220|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|-0.002||||0.5201|TWO_SIDED|90.0|-0.145|0.142||1-sided p-value|Cochran-Mantel-Haenszel|Statistics of risk difference are calculated using the Minimum Risk Weights test.|Statistics of risk difference are calculated using the Minimum Risk Weights test.|PF-00547659 7.5 mg vs placebo||0.142|-0.145|0.5201
72480936|NCT01620255|144488220|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|0.183||||0.0217|TWO_SIDED|90.0|0.039|0.328||1-sided p-value|Cochran-Mantel-Haenszel|Statistics of risk difference are calculated using the Minimum Risk Weights test.|Statistics of risk difference are calculated using the Minimum Risk Weights test.|PF-00547659 22.5 mg vs placebo||0.328|0.039|0.0217
72480937|NCT01620255|144488220|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|0.096||||0.1473|TWO_SIDED|90.0|-0.045|0.237||1-sided p-value|Cochran-Mantel-Haenszel|Statistics of risk difference are calculated using the Minimum Risk Weights test.|Statistics of risk difference are calculated using the Minimum Risk Weights test.|PF-00547659 75 mg vs placebo||0.237|-0.045|0.1473
72510133|NCT01953328|144550883|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-74.27|STANDARD_ERROR_OF_MEAN|2.35|<|0.001|TWO_SIDED|95.0|-78.93|-69.6||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|The null hypothesis was that there was no difference in the percent change from baseline at the mean of Weeks 10 and 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.||-69.60|-78.93|<0.001
72566778|NCT01300052|144664406|SUPERIORITY_OR_OTHER||Difference in Percentage|3.8|||||TWO_SIDED|95.0|-14.3|21.8||||||Difference in percentage was calculated as values of AN2728 Ointment, 2% group minus values of AN2728 Ointment, Vehicle group.||21.8|-14.3|
72401538|NCT01344161|144310183|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.05||||0.001|TWO_SIDED|95.0|||||ANCOVA|An analysis of covariance (ANCOVA) was used to adjust mean differences on all variables.||||||0.001
72401539|NCT02967692|144310195|SUPERIORITY||Hazard Ratio (HR)|0.82||||0.042|TWO_SIDED|95.0|0.655|1.027|||Log Rank|||||1.027|0.655|0.042
72401540|NCT02967692|144310203|SUPERIORITY||Hazard Ratio (HR)|1.183||||0.2975|TWO_SIDED|95.0|0.865|1.619|||Log Rank|||||1.619|0.865|0.2975
72401541|NCT04916600|144310220|SUPERIORITY||Difference in percentages|22.0||||0.043|TWO_SIDED|||||The threshold for statistical significance was p = .05|Chi-squared||Treatment difference = Active device \>=24 hour group - remainder of participants (Active \<24 hr, Sham \>=24 hr, and Sham \<24 hr groups)|||||.043
72401542|NCT04916600|144310221|SUPERIORITY||Mean Difference (Net)|-3.4||||0.032|TWO_SIDED|||||The threshold for statistical significance was p = .05|t-test, 2 sided|df=101||||||.032
72401543|NCT00066066|144310222|SUPERIORITY_OR_OTHER||||||>|0.05||||||The p-value was not adjusted for multiple comparisons and the a priori threshold for significance was alpha = 0.05|ANOVA|||The null hypothesis of no difference among treatment groups in non-smokers was tested by comparing change in mean CAL in individuals at 3 months post-therapy.||||>0.05
72401544|NCT00066066|144310222|SUPERIORITY_OR_OTHER||||||>|0.05||||||The p-value was not adjusted for multiple comparisons and the a priori threshold for significance was alpha = 0.05|ANOVA|||The null hypothesis of no difference among treatment groups in non-smokers was tested by comparing change in mean CAL in individuals at 6 months post-therapy.||||>0.05
72401545|NCT00066066|144310222|SUPERIORITY_OR_OTHER||||||<|0.05||95.0||||The p-value was not adjusted for multiple comparisons and the a priori threshold for significance was alpha = 0.05|ANOVA|||The null hypothesis of no difference among treatment groups in non-smokers was tested by comparing change in mean CAL in individuals at 12 months post-therapy.||||<0.05
72401546|NCT00066066|144310222|SUPERIORITY_OR_OTHER||||||<|0.05||95.0||||The p-value was not adjusted for multiple comparisons and the a priori threshold for significance was alpha = 0.05|ANOVA|||The null hypothesis of no difference among treatment groups in smokers was tested by comparing change in mean CAL in individuals at 3 months post-therapy.||||<0.05
72401547|NCT00066066|144310222|SUPERIORITY_OR_OTHER||||||<|0.05||95.0||||The p-value was not adjusted for multiple comparisons and the a priori threshold for significance was alpha = 0.05|ANOVA|||The null hypothesis of no difference among treatment groups in smokers was tested by comparing change in mean CAL in individuals at 6 months post-therapy.||||<0.05
72401548|NCT00066066|144310222|SUPERIORITY_OR_OTHER||||||>|0.05||95.0||||The p-value was not adjusted for multiple comparisons and the a priori threshold for significance was alpha = 0.05|ANOVA|||The null hypothesis of no difference among treatment groups in smokers was tested by comparing change in mean CAL in individuals at 12 months post-therapy.||||>0.05
72401549|NCT00697515|144310398|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||ANOVA|||||||<0.0001
72401550|NCT00697515|144310399|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0017||95.0|||||ANOVA|||2.0 hours post-dose||||0.0017
72401551|NCT00697515|144310399|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||ANOVA|||4.0 hours post-dose||||<0.0001
72566779|NCT01231373|144664413|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.34|||<|0.0001|TWO_SIDED|95.0|-4.63|-2.04|||ANCOVA|||Comparison of polidocanol treatment groups versus placebo (absolute change from baseline to week 8 in patient assessment of symptoms of varicose veins (VVSymQ) score.||-2.04|-4.63|<0.0001
72401552|NCT00697515|144310399|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||ANOVA|||8.0 hours post-dose||||<0.0001
72401553|NCT00697515|144310399|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||ANOVA|||10.0 hours post-dose||||<0.0001
72401554|NCT00697515|144310399|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||ANOVA|||12.0 hours post-dose||||<0.0001
72401555|NCT00697515|144310399|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||ANOVA|||14.0 hours post-dose||||<0.0001
72401556|NCT00697515|144310400|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||ANOVA|||Average over the treatment day||||<0.0001
72401557|NCT00697515|144310400|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001||95.0|||||ANOVA|||2.0 hours post-dose||||0.0010
72401558|NCT00697515|144310400|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||ANOVA|||4.0 hours post-dose||||<0.0001
72401559|NCT00697515|144310400|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||ANOVA|||8.0 hours post-dose||||<0.0001
72401560|NCT00697515|144310400|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||ANOVA|||10.0 hours post-dose||||<0.0001
72401561|NCT00697515|144310400|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||ANOVA|||12.0 hours post-dose||||<0.0001
72401562|NCT00697515|144310400|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||ANOVA|||14.0 hours post-dose||||<0.0001
72401563|NCT00697515|144310401|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||ANOVA|||Over the treatment day||||<0.0001
72401564|NCT00697515|144310401|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0031||95.0|||||ANOVA|||2.0 hours post-dose||||0.0031
72401565|NCT00697515|144310401|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||ANOVA|||4.0 hours post-dose||||<0.0001
72401566|NCT00697515|144310401|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||ANOVA|||8.0 hours post-dose||||<0.0001
72401567|NCT00697515|144310401|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||ANOVA|||10.0 hours post-dose||||<0.0001
72401568|NCT00697515|144310401|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||ANOVA|||12.0 hours post-dose||||<0.0001
72401569|NCT00697515|144310401|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||ANOVA|||14.0 hours post-dose||||<0.0001
72401570|NCT00697515|144310402|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||t-test, 2 sided|||||||<0.0001
72401571|NCT00697515|144310403|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||ANOVA|||||||<0.0001
72401572|NCT00697515|144310406|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||Prescott's Test|||||||<0.0001
72401573|NCT00697515|144310407|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||t-test, 2 sided|||||||<0.0001
72401574|NCT00697515|144310409|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||t-test, 2 sided|||||||<0.0001
72401575|NCT00697515|144310410|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||t-test, 2 sided|||||||<0.0001
72401576|NCT03054857|144310429|SUPERIORITY||Risk Ratio (RR)|1.532||||0.289|TWO_SIDED|95.0|0.689|3.406|||Chi-squared|||||3.406|0.689|0.289
72401577|NCT03054857|144310430|SUPERIORITY||Risk Ratio (RR)|1.329||||0.636|TWO_SIDED|95.0|0.409|4.319|||Chi-squared|||||4.319|0.409|0.636
72401578|NCT03054857|144310432|SUPERIORITY||Mean Difference (Final Values)|-1.053|STANDARD_DEVIATION|0.792||0.187|TWO_SIDED|95.0|-2.626|0.52|||t-test, 2 sided|||||0.52|-2.626|0.187
72566780|NCT01231373|144664413|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.0|||<|0.0001|TWO_SIDED|95.0|-5.26|-2.74|||ANCOVA|||||-2.74|-5.26|<0.0001
72401579|NCT03054857|144310433|SUPERIORITY||Mean Difference (Final Values)|-4.644|STANDARD_DEVIATION|7.606||0.543|TWO_SIDED|95.0|-19.74|10.45|||t-test, 2 sided|||||10.45|-19.74|0.543
72401580|NCT02603432|144310434|SUPERIORITY||Hazard Ratio (HR)|0.69||||0.0005|TWO_SIDED|95.0|0.556|0.863||One-sided log-rank test was used.|Log Rank|Analysis was performed using a Cox's Proportional Hazard model.||||0.863|0.556|0.0005
72401581|NCT02603432|144310457|SUPERIORITY||Cox Proportional Hazard|1.26||||0.913|ONE_SIDED|95.0|0.901||||Log Rank||||||0.901|0.9130
72401582|NCT02666183|144310460|OTHER||Estimated marginal mean difference|-2.251||||0.162|TWO_SIDED|95.0|-5.051|0.55|||ANCOVA|Covariates: DCG age, gender, race, income||||0.550|-5.051|0.162
72401583|NCT02666183|144310460|OTHER||Estimated marginal mean difference|-3.663||||0.007|TWO_SIDED|95.0|-6.538|-0.789|||ANCOVA|Covariates: DCG age, gender, race, income||||-0.789|-6.538|0.007
72401584|NCT02666183|144310460|OTHER||Estimated marginal mean difference|-1.413||||0.714|TWO_SIDED|95.0|-4.29|1.464|||ANCOVA|Covariates: DCG age, gender, race, income||||1.464|-4.290|0.714
72401585|NCT02666183|144310461|OTHER||Estimated marginal mean difference|-0.531||||0.173|TWO_SIDED|95.0|-1.297|0.234|||ANCOVA|Covariates: DCG age, gender, race, income||||0.234|-1.297|0.173
72401586|NCT02666183|144310461|OTHER||Estimated marginal mean difference|-1.456||||0.001|TWO_SIDED|95.0|-2.241|-0.671|||ANCOVA|Covariates: DCG age, gender, race, income||||-0.671|-2.241|0.001
72401587|NCT02666183|144310461|OTHER||Estimated marginal mean difference|-0.925||||0.021|TWO_SIDED|95.0|-1.711|-0.139|||ANCOVA|Covariates: DCG age, gender, race, income||||-0.139|-1.711|0.021
72401588|NCT02666183|144310462|OTHER||Estimated marginal mean difference|-0.984||||0.323|TWO_SIDED|95.0|-2.939|0.971|||ANCOVA|Covariates: DCG age, gender, race, income||||0.971|-2.939|0.323
72623960|NCT02038647|144778313|SUPERIORITY||Odds Ratio (OR)|0.01||||0.283|TWO_SIDED|95.0|0.01|9999.99||Stratification factors were disease subtypes (sensitive versus resistant/refractory), the presence of brain metastases and region.|Weighted Cochran-Mantel-Haenszel test||Logistic regression using CRR as dependent variable, treatment arm as independent variable and disease subtype (sensitive vs resistant/refractory) and presence of brain metastases as stratification factors.|||9999.99|0.01|0.283
72401589|NCT02666183|144310462|OTHER||Estimated marginal mean difference|-1.768||||0.086|TWO_SIDED|95.0|-3.785|0.249|||ANCOVA|Covariates: DCG age, gender, race, income||||0.249|-3.785|0.086
72401590|NCT02666183|144310462|OTHER||Estimated marginal mean difference|-0.784||||0.443|TWO_SIDED|95.0|-2.794|1.226|||ANCOVA|Covariates: DCG age, gender, race, income||||1.226|-2.794|0.443
72401591|NCT00456521|144310471|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.21|||<|0.001||95.0|-5.56|-2.86|||ANCOVA|||||-2.86|-5.56|<0.001
72401592|NCT00456521|144310472|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.89|||<|0.001||95.0|2.02|4.13|||Regression, Logistic|||||4.13|2.02|<0.001
72401593|NCT00456521|144310473|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.92|||<|0.001|TWO_SIDED|95.0|1.95|4.37|||Regression, Logistic|||||4.37|1.95|<0.001
72401594|NCT00456521|144310474|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.21|||<|0.001|TWO_SIDED|95.0|-4.82|-1.6|||ANCOVA|||||-1.60|-4.82|<0.001
72401595|NCT00456521|144310475|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-8.11||||0.004|TWO_SIDED||||||ANCOVA|||||||0.004
72401596|NCT00456521|144310476|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-12.53||||0.003|TWO_SIDED||||||ANCOVA|||||||0.003
72401597|NCT00456521|144310477|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.23|||<|0.001|TWO_SIDED|95.0|1.52|4.95|||ANCOVA|||||4.95|1.52|<0.001
72401598|NCT00456521|144310478|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.14||||0.001|TWO_SIDED|95.0|1.23|5.04|||ANCOVA|||||5.04|1.23|0.001
72401599|NCT00456521|144310479|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-13.37||||0.003|TWO_SIDED||||||ANCOVA|||||||0.003
72401600|NCT00456521|144310480|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-8.98||||0.165|TWO_SIDED||||||ANCOVA|||||||0.165
72401601|NCT00456521|144310481|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.28|||||TWO_SIDED|95.0|-3.34|0.79||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||0.79|-3.34|
72401602|NCT00456521|144310482|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.7|||||TWO_SIDED|95.0|-7.26|1.86||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||1.86|-7.26|
72401603|NCT00456521|144310483|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.55|||||TWO_SIDED|95.0|0.97|4.14||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||4.14|0.97|
72401604|NCT00456521|144310484|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.37|||||TWO_SIDED|95.0|0.25|2.49||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||2.49|0.25|
72401605|NCT00456521|144310485|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.09|||||TWO_SIDED|95.0|-0.7|0.87||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||0.87|-0.70|
72401606|NCT00456521|144310486|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.11|||||TWO_SIDED|95.0|-0.85|0.63||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||0.63|-0.85|
72401607|NCT00456521|144310487|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.09|||||TWO_SIDED|95.0|-0.78|0.6||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||0.60|-0.78|
72401608|NCT00456521|144310488|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.29|||||TWO_SIDED|95.0|-9.16|-1.42||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||-1.42|-9.16|
72623961|NCT02038647|144778314|SUPERIORITY||Odds Ratio (OR)|0.59||||0.077|TWO_SIDED|95.0|0.32|1.08||Stratification factors were disease subtypes (sensitive versus resistant/refractory), the presence of brain metastases and region.|Weighted Cochran-Mantel-Haenszel test||Logistic regression using DCR as dependent variable, treatment arm as independent variable and disease subtype (sensitive vs resistant/refractory) and presence of brain metastases as stratification factors.|||1.08|0.32|0.077
72480938|NCT01620255|144488220|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|0.112||||0.1231|TWO_SIDED|90.0|-0.038|0.261||1-sided p-value|Cochran-Mantel-Haenszel|Statistics of risk difference are calculated using the Minimum Risk Weights test.|Statistics of risk difference are calculated using the Minimum Risk Weights test.|PF-00547659 225 mg vs placebo||0.261|-0.038|0.1231
72480939|NCT04256603|144488230|OTHER|||||||0.67|||||||Wilcoxon (Mann-Whitney)|||wilcox two sample test||||0.67
72480940|NCT00388453|144488236|SUPERIORITY_OR_OTHER|||||||0.05|||||||Wilcoxon (Mann-Whitney)|||||||.05
72480941|NCT03818204|144488249|OTHER||||||>=|0.46|||||||Regression, Linear|||The effect of angular position was modeled using linear mixed-effects (multiple regression) models. The five angles were randomly mapped for the dependent variable interpalpebral fissure. Because there were repeated measurements on each eye and each participant might respond differently to each angular position, participant and angular position within participant-eye were included as random effects.||||>=0.46
72480942|NCT00879762|144488257|NON_INFERIORITY|The non-inferiority margin is 2.5. Non-inferiority of Group B is concluded if the upper limit of the 95% confidence interval for the hazard ratio is less than 2.5.|Hazard Ratio (HR)|0.587|||||TWO_SIDED|95.0|0.398|0.868|||||A survival analysis for interval censored data was performed to estimate the hazard ratio. The 95% CI for the hazard ratio was estimated using bootstrap.|Null hypothesis: Median time to seroconversion among participants receiving one standard dose in Group B is 2.5-fold higher compared to participants receiving one high dose in Group A (hazard ratio = 2.5).||0.868|0.398|
72480943|NCT00879762|144488258|NON_INFERIORITY|The non-inferiority margin is 2.5. Non-inferiority of Group B is concluded if the upper limit of the 95% confidence interval for the hazard ratio is less than 2.5.|Hazard Ratio (HR)|0.583|||||TWO_SIDED|95.0|0.384|0.853|||||A survival analysis for interval censored data was performed to estimate the hazard ratio. The 95% CI for the hazard ratio was estimated using bootstrap.|Null hypothesis: Median time to seroconversion among participants receiving one standard dose in Group B is 2.5-fold higher compared to participants receiving one high dose in Group A (hazard ratio = 2.5).||0.853|0.384|
72480944|NCT00879762|144488264|NON_INFERIORITY|The non-inferiority margin is 1. Non-inferiority of Group B is concluded if the upper limit of the 95% confidence interval for the mean difference in the log2.5 transformed peak titers between groups is less than 1.|Mean Difference (Final Values)|0.38|||||TWO_SIDED|95.0|-0.2|0.97|||||Estimate and corresponding 95% confidence interval are calculated on the log2.5 scale.|Null hypothesis: The mean difference in log2.5 transformed peak titers between Group A and Group B \>= 1.||0.97|-0.20|
72480945|NCT00879762|144488265|NON_INFERIORITY|The non-inferiority margin is 1. Non-inferiority of Group B is concluded if the upper limit of the 95% confidence interval for the mean difference in the log2.5 transformed peak titers between groups is less than 1.|Mean Difference (Final Values)|0.42|||||TWO_SIDED|95.0|-0.17|1.0|||||Estimate and corresponding 95% confidence interval are calculated on the log2.5 scale.|Null hypothesis: The mean difference in log2.5 transformed peak titers between Group A and Group B \>= 1.||1.00|-0.17|
72401609|NCT00464568|144310563|SUPERIORITY_OR_OTHER||Treatment Ratios|1.14|STANDARD_ERROR_OF_MEAN|0.037||0.1351|TWO_SIDED|95.0|0.96|1.35|||ANOVA|||CREM; Placebo vs GSK256066 1 mcg||1.35|0.96|0.1351
72480946|NCT04981366|144488266|SUPERIORITY|||||||0.013|TWO_SIDED|95.0||||We applied the restricted maximum likelihood, compound symmetry covariance structure, and Kenward-Roger degrees of freedom approximation. To maintain the significance level at 0.05, the primary endpoints were assessed using Hochberg's procedure.|Mixed Models Analysis|||||||0.013
72480947|NCT04981366|144488267|SUPERIORITY||||||<|0.001||||||We applied the restricted maximum likelihood, compound symmetry covariance structure, and Kenward-Roger degrees of freedom approximation. To maintain the significance level at 0.05, the primary endpoints were assessed using Hochberg's procedure.|Mixed Models Analysis|||||||<0.001
72480948|NCT04981366|144488268|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
72480949|NCT04981366|144488269|SUPERIORITY|||||||0.007||||||We applied the restricted maximum likelihood, compound symmetry covariance structure, and Kenward-Roger degrees of freedom approximation. To maintain the significance level at 0.05, the primary endpoints were assessed using Hochberg's procedure.|Mixed Models Analysis|||||||0.007
72510134|NCT01953328|144550884|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-74.85|STANDARD_ERROR_OF_MEAN|2.71|<|0.001|TWO_SIDED|95.0|-80.22|-69.47||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|The null hypothesis was that there was no difference in the percent change from baseline at Week 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.||-69.47|-80.22|<0.001
72480950|NCT04981366|144488270|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
72480951|NCT04981366|144488271|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
72480952|NCT04981366|144488272|SUPERIORITY|||||||0.005|||||||Mixed Models Analysis|||||||0.005
72480953|NCT04981366|144488273|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
72480954|NCT04981366|144488274|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
72480955|NCT04981366|144488275|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
72480956|NCT04981366|144488276|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
72480957|NCT04981366|144488277|SUPERIORITY|||||||0.001|||||||Mixed Models Analysis|||||||0.001
72480958|NCT04981366|144488278|SUPERIORITY|||||||0.033|||||||Mixed Models Analysis|||||||0.033
72401610|NCT00464568|144310563|SUPERIORITY_OR_OTHER||Treatment Ratios|1.19|STANDARD_ERROR_OF_MEAN|0.037||0.0383|TWO_SIDED|95.0|1.01|1.41|||ANOVA|||CREM; Placebo vs GSK256066 10 mcg||1.41|1.01|0.0383
72480959|NCT04981366|144488279|SUPERIORITY|||||||0.944|||||||Mixed Models Analysis|||||||0.944
72480960|NCT04981366|144488280|SUPERIORITY|||||||0.203|||||||Mixed Models Analysis|||||||0.203
72480961|NCT04981366|144488281|SUPERIORITY|||||||0.027|||||||Mixed Models Analysis|||||||0.027
72480962|NCT04981366|144488282|SUPERIORITY|||||||0.145|||||||Mixed Models Analysis|||||||0.145
72480963|NCT04981366|144488283|SUPERIORITY|||||||0.001|||||||Mixed Models Analysis|||||||0.001
72401611|NCT00464568|144310563|SUPERIORITY_OR_OTHER||Treatment Ratios|1.2|STANDARD_ERROR_OF_MEAN|0.037||0.0325|TWO_SIDED|95.0|1.02|1.43|||ANOVA|||CREM; Placebo vs GSK256066 50 mcg||1.43|1.02|0.0325
72401612|NCT00464568|144310563|SUPERIORITY_OR_OTHER||Treatment Ratios|1.42|STANDARD_ERROR_OF_MEAN|0.037|<|0.0001|TWO_SIDED|95.0|1.2|1.68|||ANOVA|||CREM; Placebo vs GSK256066 200 mcg||1.68|1.20|<0.0001
72401613|NCT00464568|144310563|SUPERIORITY_OR_OTHER||Treatment Ratios|1.45|STANDARD_ERROR_OF_MEAN|0.049||0.0015|TWO_SIDED|95.0|1.16|1.82|||ANOVA|||DUSP1; Placebo vs GSK256066 1 mcg||1.82|1.16|0.0015
72480964|NCT04981366|144488284|SUPERIORITY|||||||0.551|||||||Mixed Models Analysis|||||||0.551
72480965|NCT04981366|144488285|SUPERIORITY|||||||0.001|||||||Mixed Models Analysis|||||||0.001
72480966|NCT04981366|144488286|SUPERIORITY|||||||0.001|||||||Mixed Models Analysis|||||||0.001
72480967|NCT04981366|144488287|SUPERIORITY|||||||0.001|||||||Mixed Models Analysis|||||||0.001
72480968|NCT04981366|144488288|SUPERIORITY|||||||0.008|||||||Mixed Models Analysis|||||||0.008
72480969|NCT04981366|144488289|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
72480970|NCT04981366|144488290|SUPERIORITY|||||||0.344|||||||Mixed Models Analysis|||||||0.344
72401614|NCT00464568|144310563|SUPERIORITY_OR_OTHER||Treatment Ratios|1.55|STANDARD_ERROR_OF_MEAN|0.049||0.0002|TWO_SIDED|95.0|1.24|1.93|||ANOVA|||DUSP1; Placebo vs GSK256066 10 mcg||1.93|1.24|0.0002
72480971|NCT04981366|144488291|SUPERIORITY|||||||0.613|||||||Mixed Models Analysis|||||||0.613
72480972|NCT04981366|144488292|SUPERIORITY|||||||0.944|||||||Mixed Models Analysis|||||||0.944
72480973|NCT04981366|144488293|SUPERIORITY|||||||0.601|||||||Mixed Models Analysis|||||||0.601
72480974|NCT04981366|144488294|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
72480975|NCT04981366|144488295|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
72480976|NCT04981366|144488296|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
72480977|NCT04981366|144488298|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
72401615|NCT00464568|144310563|SUPERIORITY_OR_OTHER||Treatment Ratios|1.74|STANDARD_ERROR_OF_MEAN|0.05|<|0.0001|TWO_SIDED|95.0|1.38|2.17|||ANOVA|||DUSP1; Placebo vs GSK256066 50 mcg||2.17|1.38|<0.0001
72480978|NCT04981366|144488299|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
72401616|NCT00464568|144310563|SUPERIORITY_OR_OTHER||Treatment Ratios|1.75|STANDARD_ERROR_OF_MEAN|0.049|<|0.0001|TWO_SIDED|95.0|1.4|2.18|||ANOVA|||DUSP1; Placebo vs GSK256066 200 mcg||2.18|1.40|<0.0001
72401617|NCT00464568|144310563|SUPERIORITY_OR_OTHER||Treatment Ratios|1.49|STANDARD_ERROR_OF_MEAN|0.043||0.0001|TWO_SIDED|95.0|1.22|1.81|||ANOVA|||FOSL2; Placebo vs GSK256066 1 mcg||1.81|1.22|0.0001
72480979|NCT04981366|144488300|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
72480980|NCT04981366|144488301|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
72480981|NCT04981366|144488302|SUPERIORITY|||||||0.017|||||||Mixed Models Analysis|||||||0.017
72480982|NCT04981366|144488303|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
72480983|NCT04981366|144488304|SUPERIORITY|||||||0.949|||||||Mixed Models Analysis|||||||0.949
72480984|NCT04981366|144488305|SUPERIORITY|||||||0.993|||||||Mixed Models Analysis|||||||0.993
72480985|NCT04981366|144488306|SUPERIORITY|||||||0.601|||||||Mixed Models Analysis|||||||0.601
72480986|NCT04981366|144488307|SUPERIORITY|||||||0.408|||||||Mixed Models Analysis|||||||0.408
72480987|NCT04981366|144488308|SUPERIORITY|||||||0.082|||||||Mixed Models Analysis|||||||0.082
72480988|NCT04981366|144488309|SUPERIORITY|||||||0.55|||||||Mixed Models Analysis|||||||0.550
72480989|NCT04981366|144488310|SUPERIORITY|||||||0.7|||||||Mixed Models Analysis|||||||0.700
72480990|NCT04981366|144488311|SUPERIORITY|||||||0.254|||||||Mixed Models Analysis|||||||0.254
72480991|NCT04981366|144488312|SUPERIORITY|||||||0.373|||||||Mixed Models Analysis|||||||0.373
72480992|NCT04981366|144488313|SUPERIORITY|||||||0.407|||||||Mixed Models Analysis|||||||0.407
72480993|NCT04981366|144488314|SUPERIORITY|||||||0.051|||||||Mixed Models Analysis|||||||0.051
72480994|NCT04981366|144488315|SUPERIORITY|||||||0.385|||||||Mixed Models Analysis|||||||0.385
72480995|NCT04981366|144488316|SUPERIORITY|||||||0.239|||||||Mixed Models Analysis|||||||0.239
72480996|NCT04981366|144488317|SUPERIORITY|||||||0.463|||||||Mixed Models Analysis|||||||0.463
72480997|NCT04981366|144488318|SUPERIORITY|||||||0.032|||||||Mixed Models Analysis|||||||0.032
72480998|NCT04981366|144488319|SUPERIORITY|||||||0.469|||||||Mixed Models Analysis|||||||0.469
72480999|NCT04981366|144488320|SUPERIORITY|||||||0.013|||||||Mixed Models Analysis|||||||0.013
72481000|NCT04981366|144488321|SUPERIORITY|||||||0.064|||||||Mixed Models Analysis|||||||0.064
72481001|NCT04981366|144488322|SUPERIORITY|||||||0.0314|||||||Mixed Models Analysis|||||||0.0314
72481002|NCT04981366|144488323|SUPERIORITY|||||||0.0147|||||||Mixed Models Analysis|||||||0.0147
72481003|NCT04981366|144488324|SUPERIORITY|||||||0.007|||||||Mixed Models Analysis|||||||0.007
72481004|NCT04981366|144488325|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
72481005|NCT04981366|144488326|SUPERIORITY|||||||0.001|||||||Mixed Models Analysis|||||||0.001
72481006|NCT00676065|144488337|NON_INFERIORITY_OR_EQUIVALENCE|The LASS study was designed to analyse rare events (incidence rate \<1 per 1,000 woman-years and ≥ 1 per 10,000 WY). 300,000 WY of observation would be sufficient to exclude a two-fold risk of rare events in users of DRSP compared to other oral contraceptives with a power (1-β) of 0.80 and an one-sided α of 0.05.|Hazard Ratio (HR)|0.4|||||TWO_SIDED|95.0|0.2|0.9|||||Hazard ratio was adjusted for age, BMI, smoking, hypertension and family history|Tested null hypotheses: the ATE hazard ratio for DRSP/E2 vs. OCs containing LNG is higher or equal to 2.||0.9|0.2|
72481007|NCT00676065|144488337|NON_INFERIORITY_OR_EQUIVALENCE|The LASS study was designed to analyse rare events (incidence rate \<1 per 1,000 woman-years and ≥ 1 per 10,000 WY). 300,000 WY of observation would be sufficient to exclude a two-fold risk of rare events in users of DRSP compared to other oral contraceptives with a power (1-β) of 0.80 and an one-sided α of 0.05.|Hazard Ratio (HR)|0.4|||||TWO_SIDED|95.0|0.2|0.9|||||Hazard ratio was adjusted for age, BMI, smoking, hypertension and family history|Tested null hypotheses: the ATE hazard ratio for DRSP/E2 vs. OCs containing other progestogens is higher or equal to 2.||0.9|0.2|
72566781|NCT01231373|144664413|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.05|||<|0.0001|TWO_SIDED|95.0|-4.33|-1.77|||ANCOVA|||||-1.77|-4.33|<0.0001
72481008|NCT00676065|144488338|NON_INFERIORITY_OR_EQUIVALENCE|The LASS study was designed to analyse rare events (incidence rate \<1 per 1,000 woman-years and ≥ 1 per 10,000 WY). 300,000 WY of observation would be sufficient to exclude a two-fold risk of rare events in users of DRSP compared to other oral contraceptives with a power (1-β) of 0.80 and an one-sided α of 0.05.|Hazard Ratio (HR)|1.1|||||TWO_SIDED|95.0|0.8|1.7|||||Hazard ratio was adjusted for age, BMI, current duration of use, and family history of VTE.|Tested null hypotheses: the VTE hazard ratio for DRSP/E2 vs. OCs containing LNG is higher or equal to 2.||1.7|0.8|
72401618|NCT00464568|144310563|SUPERIORITY_OR_OTHER||Treatment Ratios|1.52|STANDARD_ERROR_OF_MEAN|0.043|<|0.0001|TWO_SIDED|95.0|1.25|1.85|||ANOVA|||FOSL2; Placebo vs GSK256066 10 mcg||1.85|1.25|<0.0001
72481009|NCT00676065|144488338|NON_INFERIORITY_OR_EQUIVALENCE|The LASS study was designed to analyse rare events (incidence rate \<1 per 1,000 woman-years and ≥ 1 per 10,000 WY). 300,000 WY of observation would be sufficient to exclude a two-fold risk of rare events in users of DRSP compared to other oral contraceptives with a power (1-β) of 0.80 and an one-sided α of 0.05.|Hazard Ratio (HR)|0.7|||||TWO_SIDED|95.0|0.5|1.0|||||Hazard ratio was adjusted for age, BMI, current duration of use, and family history of VTE.|Tested null hypotheses: the VTE hazard ratio for DRSP/E2 vs. OCs containing other progestogens is higher or equal to 2.||1.0|0.5|
72481010|NCT00676065|144488339|NON_INFERIORITY_OR_EQUIVALENCE|The LASS study was designed to analyse rare events (incidence rate \<1 per 1,000 woman-years and ≥ 1 per 10,000 WY). 300,000 WY of observation would be sufficient to exclude a two-fold risk of rare events in users of DRSP compared to other oral contraceptives with a power (1-β) of 0.80 and an one-sided α of 0.05.|Hazard Ratio (HR)|0.9|||||TWO_SIDED|95.0|0.5|1.4|||||Hazard ratio was adjusted for age, BMI, smoking, educational level and age at menarche.|Tested null hypotheses: the breast cancer hazard ratio for DRSP/E2 vs. OCs containing LNG is higher or equal to 2.||1.4|0.5|
72481011|NCT00676065|144488339|NON_INFERIORITY_OR_EQUIVALENCE|The LASS study was designed to analyse rare events (incidence rate \<1 per 1,000 woman-years and ≥ 1 per 10,000 WY). 300,000 WY of observation would be sufficient to exclude a two-fold risk of rare events in users of DRSP compared to other oral contraceptives with a power (1-β) of 0.80 and an one-sided α of 0.05.|Hazard Ratio (HR)|1.0|||||TWO_SIDED|95.0|0.6|1.5|||||Hazard ratio was adjusted for age, BMI, smoking, educational level and age at menarche.|Tested null hypotheses: the breast cancer hazard ratio for DRSP/E2 vs. OCs containing other progestogens is higher or equal to 2.||1.5|0.6|
72481012|NCT03401229|144488447|SUPERIORITY||Mean Difference (Net)|-0.57|||<|0.0001|TWO_SIDED|95.0|-0.852|-0.289||To account for multiplicity, a pre-specified testing strategy was followed to control the overall type I error rate. Both of the co-primary endpoints were tested at 0.01 (two-sided).|ANCOVA|ANCOVA following hybrid WP/WOCF and MI (assuming MAR), adjusting for treatment, baseline score, region (US/Non-US) and baseline comorbid asthma status||The primary analysis compared the changes from baseline of benralizumab with placebo. H0: The change from baseline in total NPS and/or the change from baseline in NBS are similar between benralizumab and placebo. H1: Both of the change from baseline in total NPS and the change from baseline in NBS are different between benralizumab and placebo.||-0.289|-0.852|<0.0001
72481013|NCT03401229|144488448|SUPERIORITY||Mean Difference (Net)|-0.27||||0.0048|TWO_SIDED|95.0|-0.458|-0.083||To account for multiplicity, a pre-specified testing strategy was followed to control the overall type I error rate. Both of the co-primary endpoints were tested at 0.01 (two-sided).|ANCOVA|ANCOVA following hybrid WP/WOCF and MI (assuming MAR), adjusting for treatment, baseline score, region (US/Non-US) and baseline comorbid asthma status||The primary analysis compared the changes from baseline of benralizumab with placebo. H0: The change from baseline in total NPS and/or the change from baseline in NBS are similar between benralizumab and placebo. H1: Both of the change from baseline in total NPS and the change from baseline in NBS are different between benralizumab and placebo.||-0.083|-0.458|0.0048
72401619|NCT00464568|144310563|SUPERIORITY_OR_OTHER||Treatment Ratios|1.68|STANDARD_ERROR_OF_MEAN|0.043|<|0.0001|TWO_SIDED|95.0|1.38|2.05|||ANOVA|||FOSL2; Placebo vs GSK256066 50 mcg||2.05|1.38|<0.0001
72401620|NCT00464568|144310563|SUPERIORITY_OR_OTHER||Treatment Ratios|1.55|STANDARD_ERROR_OF_MEAN|0.043|<|0.0001|TWO_SIDED|95.0|1.28|1.89|||ANOVA|||FOSL2; Placebo vs GSK256066 200 mcg||1.89|1.28|<0.0001
72401621|NCT00464568|144310563|SUPERIORITY_OR_OTHER||Treatment Ratios|1.55|STANDARD_ERROR_OF_MEAN|0.064||0.0034|TWO_SIDED|95.0|1.16|2.07|||ANOVA|||IRS2; Placebo vs GSK256066 1 mcg||2.07|1.16|0.0034
72566782|NCT01231373|144664414|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.66|STANDARD_ERROR_OF_MEAN|0.081|<|0.0001|TWO_SIDED|95.0|-0.88|-0.45|||ANCOVA|||||-0.45|-0.88|<0.0001
72566783|NCT01231373|144664414|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.82|STANDARD_ERROR_OF_MEAN|0.078|<|0.0001|TWO_SIDED|95.0|-1.04|-0.61|||ANCOVA|||||-0.61|-1.04|<0.0001
72566784|NCT01231373|144664414|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.75|||<|0.0001|TWO_SIDED|95.0|-0.97|-0.54|||ANCOVA|||||-0.54|-0.97|<0.0001
72566785|NCT01231373|144664415|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.23|STANDARD_ERROR_OF_MEAN|0.131|<|0.0001|TWO_SIDED|95.0|-1.59|-0.87|||ANCOVA|||||-0.87|-1.59|<0.0001
72401622|NCT00464568|144310563|SUPERIORITY_OR_OTHER||Treatment Ratios|1.55|STANDARD_ERROR_OF_MEAN|0.063||0.0029|TWO_SIDED|95.0|1.17|2.07|||ANOVA|||IRS2; Placebo vs GSK256066 10 mcg||2.07|1.17|0.0029
72401623|NCT00464568|144310563|SUPERIORITY_OR_OTHER||Treatment Ratios|1.74|STANDARD_ERROR_OF_MEAN|0.064||0.0003|TWO_SIDED|95.0|1.3|2.33|||ANOVA|||IRS2; Placebo vs GSK256066 50 mcg||2.33|1.30|0.0003
72401624|NCT00464568|144310563|SUPERIORITY_OR_OTHER||Treatment Ratios|1.56|STANDARD_ERROR_OF_MEAN|0.063||0.0027|TWO_SIDED|95.0|1.17|2.08|||ANOVA|||IRS2; Placebo vs GSK256066 200 mcg||2.08|1.17|0.0027
72401625|NCT00464568|144310563|SUPERIORITY_OR_OTHER||Treatment Ratios|1.54|STANDARD_ERROR_OF_MEAN|0.092||0.0448|TWO_SIDED|95.0|1.01|2.34|||ANOVA|||NR4A2; Placebo vs GSK256066 1 mcg||2.34|1.01|0.0448
72401626|NCT00464568|144310563|SUPERIORITY_OR_OTHER||Treatment Ratios|1.87|STANDARD_ERROR_OF_MEAN|0.091||0.0033|TWO_SIDED|95.0|1.24|2.83|||ANOVA|||NR4A2; Placebo vs GSK256066 10 mcg||2.83|1.24|0.0033
72481014|NCT03401229|144488449|SUPERIORITY||Mean Difference (Net)|-5.212||||0.0821|TWO_SIDED|95.0|-11.087|0.664||Since both primary endpoints were significant at significant level of 0.01 level, this endpoint was tested at significant level of 0.05.|ANCOVA|ANCOVA following hybrid WP/WOCF and MI (assuming MAR), adjusting for treatment, baseline score, region (US/Non-US) and baseline comorbid asthma status||This endpoint compared the changes from baseline of benralizumab with placebo. H0: The change from baseline in SNOT-22 total score is similar between benralizumab and placebo. H1: The change from baseline in SNOT-22 total score is different between benralizumab and placebo.||0.664|-11.087|0.0821
72481015|NCT03401229|144488450|SUPERIORITY||Hazard Ratio (HR)|0.75||||0.066|TWO_SIDED|95.0|0.55|1.02||Based on pre-specified testing strategy, this endpoint was not tested for statistical significance and the p-value was considered nominal because test for change from baseline in SNOT-22 at week 40 was not statistically significant.|Regression, Cox|A Cox proportional hazards model including covariates treatment group, region (US/Non-US) and baseline comorbid asthma status.||This endpoint compared the rate of incidence of first NP surgery and/or SCS use for NP between benralizumab and placebo. H0: The rate is similar between benralizumab and placebo. H1: the rate is different between benralizumab and placebo. Hazard ratio is benralizumab vs placebo and HR less than 1 indicates longer time to event||1.02|0.55|0.0660
72481016|NCT03401229|144488451|SUPERIORITY||Hazard Ratio (HR)|0.85||||0.5008|TWO_SIDED|95.0|0.53|1.36||Based on pre-specified testing strategy, this endpoint was not tested for statistical significance and the p-value was considered nominal.|Regression, Cox|A Cox proportional hazards model including covariates treatment group, region (US/Non-US) and baseline comorbid asthma status.||The endpoint compared the rate of incidence of first NP surgery between benralizumab and placebo. H0: The rate is similar between benralizumab and placebo. H1: the rate is different between benralizumab and placebo. Hazard ratio (HR) is benralizumab vs placebo and HR less than 1 indicates longer time to event||1.36|0.53|0.5008
72481017|NCT03401229|144488452|SUPERIORITY||Mean Difference (Net)|-0.218||||0.0029|TWO_SIDED|95.0|-0.361|-0.074||Based on pre-specified testing strategy, this endpoint was not tested for statistical significance and the p-value was considered nominal.|ANCOVA|ANCOVA following hybrid WP/WOCF and MI (assuming MAR), adjusting for treatment, baseline score, region (US/Non-US) and baseline comorbid asthma status||This endpoint compared the changes from baseline DSS score of benralizumab with placebo. H0: The change from baseline in DSS score is similar between benralizumab and placebo. H1: The change from baseline in DSS score is different between benralizumab and placebo.||-0.074|-0.361|0.0029
72481018|NCT03401229|144488453|SUPERIORITY||Mean Difference (Net)|-0.475||||0.0054|TWO_SIDED|95.0|-0.81|-0.141||Based on pre-specified testing strategy, this endpoint was not tested for statistical significance and the p-value was considered nominal.|ANCOVA|ANCOVA following hybrid WP/WOCF and MI (assuming MAR), adjusting for treatment, baseline score, region (US/Non-US) and baseline comorbid asthma status||This endpoint compared the changes from baseline of benralizumab with placebo. H0: The change from baseline in NPS is similar between benralizumab and placebo. H1: The change from baseline in NPS is different between benralizumab and placebo.||-0.141|-0.810|0.0054
72481019|NCT03401229|144488454|SUPERIORITY||Mean Difference (Net)|-0.287||||0.0032|TWO_SIDED|95.0|-0.477|-0.096||Based on pre-specified testing strategy, this endpoint was not tested for statistical significance and the p-value was considered nominal.|ANCOVA|ANCOVA following hybrid WP/WOCF and MI (assuming MAR), adjusting for treatment, baseline score, region (US/Non-US) and baseline comorbid asthma status||This endpoint compared the changes from baseline of benralizumab with placebo. H0: The change from baseline in NBS is similar between benralizumab and placebo. H1: The change from baseline in NBS is different between benralizumab and placebo.||-0.096|-0.477|0.0032
72481020|NCT03401229|144488455|SUPERIORITY||Mean Difference (Net)|-7.492||||0.0188|TWO_SIDED|95.0|-13.741|-1.243||Based on pre-specified testing strategy, this endpoint was not tested for statistical significance and the p-value was considered nominal.|ANCOVA|ANCOVA following hybrid WP/WOCF and MI (assuming MAR), adjusting for treatment, baseline score, region (US/Non-US) and baseline comorbid asthma status||This endpoint compared the changes from baseline of benralizumab with placebo. H0: The change from baseline in SNOT-22 total score is similar between benralizumab and placebo. H1: The change from baseline in SNOT-22 total score is different between benralizumab and placebo.||-1.243|-13.741|0.0188
72481021|NCT03401229|144488456|SUPERIORITY||Mean Difference (Net)|-0.237||||0.0023|TWO_SIDED|95.0|-0.389|-0.084||Based on pre-specified testing strategy, this endpoint was not tested for statistical significance and the p-value was considered nominal.|ANCOVA|ANCOVA following hybrid WP/WOCF and MI (assuming MAR), adjusting for treatment, baseline score, region (US/Non-US) and baseline comorbid asthma status||This endpoint compared the changes from baseline DSS score of benralizumab with placebo. H0: The change from baseline in DSS score is similar between benralizumab and placebo. H1: The change from baseline in DSS score is different between benralizumab and placebo.||-0.084|-0.389|0.0023
72481022|NCT03401229|144488457|SUPERIORITY||Mean Difference (Net)|-0.856||||0.2375|TWO_SIDED|95.0|-2.281|0.57||Based on pre-specified testing strategy, this endpoint was not tested for statistical significance and the p-value was considered nominal.|ANCOVA|ANCOVA following WP (WP for NP surgery), adjusting for treatment, baseline score, region (US/Non-US) and baseline comorbid asthma status.||This endpoint compared the changes from baseline LMS score of benralizumab with placebo. H0: The change from baseline in LMS score is similar between benralizumab and placebo. H1: The change from baseline in LMS score is different between benralizumab and placebo.||0.570|-2.281|0.2375
72566786|NCT01231373|144664415|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.54|STANDARD_ERROR_OF_MEAN|0.129|<|0.0001|TWO_SIDED|95.0|-1.9|-1.18|||ANCOVA|||||-1.18|-1.90|<0.0001
72401627|NCT00464568|144310563|SUPERIORITY_OR_OTHER||Treatment Ratios|2.16|STANDARD_ERROR_OF_MEAN|0.092||0.0004|TWO_SIDED|95.0|1.42|3.3|||ANOVA|||NR4A2; Placebo vs GSK256066 50 mcg||3.30|1.42|0.0004
72401628|NCT00464568|144310563|SUPERIORITY_OR_OTHER||Treatment Ratios|2.03|STANDARD_ERROR_OF_MEAN|0.091||0.001||95.0|1.34|3.08|||ANOVA|||NR4A2; Placebo vs GSK256066 200 mcg||3.08|1.34|0.0010
72401629|NCT00464568|144310563|SUPERIORITY_OR_OTHER||Treatment Ratios|1.03|STANDARD_ERROR_OF_MEAN|0.072||0.8718|TWO_SIDED|95.0|0.74|1.43|||ANOVA|||PDE4A; Placebo vs GSK256066 1 mcg||1.43|0.74|0.8718
72401630|NCT00464568|144310563|SUPERIORITY_OR_OTHER||Treatment Ratios|1.18|STANDARD_ERROR_OF_MEAN|0.071||0.3078|TWO_SIDED|95.0|0.86|1.63|||ANOVA|||PDE4A; Placebo vs GSK256066 10 mcg||1.63|0.86|0.3078
72481023|NCT03401229|144488458|SUPERIORITY||Odds Ratio (OR)|0.85||||0.5419|TWO_SIDED|95.0|0.51|1.43||This endpoint was not a part of the pre-specified testing strategy and was not tested for statistical significance. The p-value was considered nominal.|Cochran-Mantel-Haenszel|The odds ratio estimate was obtained from the Cochran-Mantel-Haenszel test controlling for region (US/non-US) and baseline comorbid asthma status.||This endpoint compared the proportion of subjects with NP surgery between benralizumab and placebo. H0: The proportion is similar between benralizumab and placebo. H1: The proportion is different between benralizumab and placebo.||1.43|0.51|0.5419
72481024|NCT03401229|144488459|SUPERIORITY||Odds Ratio (OR)|0.69||||0.0913|TWO_SIDED|95.0|0.44|1.06||This endpoint was not a part of the pre-specified testing strategy and was not tested for statistical significance. The p-value was considered nominal.|Cochran-Mantel-Haenszel|The odds ratio estimate was obtained from the Cochran-Mantel-Haenszel test controlling for region (US/non-US) and baseline comorbid asthma status.||This endpoint compared the proportion of subjects with SCS\_NP between benralizumab and placebo. H0: The proportion is similar between benralizumab and placebo. H1: The proportion is different between benralizumab and placebo.||1.06|0.44|0.0913
72481025|NCT03401229|144488460|SUPERIORITY||Odds Ratio (OR)|0.65||||0.0362|TWO_SIDED|95.0|0.44|0.97||This endpoint was not a part of the pre-specified testing strategy and was not tested for statistical significance. The p-value was considered nominal.|Cochran-Mantel-Haenszel|The odds ratio estimate was obtained from the Cochran-Mantel-Haenszel test controlling for region (US/non-US) and baseline comorbid asthma status.||This endpoint compared the proportion of subjects with NP surgery or SCS\_NP between benralizumab and placebo. H0: The proportion is similar between benralizumab and placebo. H1: The proportion is different between benralizumab and placebo.||0.97|0.44|0.0362
72481026|NCT03401229|144488461|SUPERIORITY||Hazard Ratio (HR)|0.77||||0.1505|TWO_SIDED|95.0|0.53|1.1||This endpoint was not a part of the pre-specified testing strategy and was not tested for statistical significance. The p-value was considered nominal.|Regression, Cox|A Cox proportional hazards model including covariates treatment group, region (US/Non-US) and baseline comorbid asthma status.||The endpoint compared the rate of incidence of SCS\_NP use between benralizumab and placebo. H0: The rate is similar between benralizumab and placebo. H1: the rate is different between benralizumab and placebo. Hazard ratio (HR) is benralizumab vs placebo and HR less than 1 indicates longer time to event||1.10|0.53|0.1505
72481027|NCT03401229|144488465|SUPERIORITY||Rate Ratio|0.79||||0.2189|TWO_SIDED|95.0|0.54|1.15||This endpoint was not a part of the pre-specified testing strategy and was not tested for statistical significance. The p-value was considered nominal.|Negative Bionomial Model|Model included treatment, US/non-US and prior use of SCS\_NP with total number of courses of SCS\_NP as outcome and log of follow-up time as an offset||The endpoint compared the rate of SCS\_NP use between benralizumab and placebo. H0: The rate is similar between benralizumab and placebo. H1: the rate is different between benralizumab and placebo. Rate ratio is benralizumab vs placebo and Rate ratio less than 1 indicates less likely of SCS\_NP use.||1.15|0.54|0.2189
72510135|NCT01953328|144550884|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-69.91|STANDARD_ERROR_OF_MEAN|2.36|<|0.001|TWO_SIDED|95.0|-74.6|-65.23||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|The null hypothesis was that there was no difference in the percent change from baseline at Week 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.||-65.23|-74.60|<0.001
72510136|NCT01953328|144550884|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-78.85|STANDARD_ERROR_OF_MEAN|3.88|<|0.001|TWO_SIDED|95.0|-83.55|-68.15||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|The null hypothesis was that there was no difference in the percent change from baseline at Week 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.||-68.15|-83.55|<0.001
72401631|NCT00464568|144310563|SUPERIORITY_OR_OTHER||Treatment Ratios|1.19|STANDARD_ERROR_OF_MEAN|0.072||0.2909|TWO_SIDED|95.0|0.86|1.66|||ANOVA|||PDE4A; Placebo vs GSK256066 50 mcg||1.66|0.86|0.2909
72566787|NCT01231373|144664415|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.47|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-1.83|-1.11|||ANCOVA|||||-1.11|-1.83|<0.0001
72401632|NCT00464568|144310563|SUPERIORITY_OR_OTHER||Treatment Ratios|1.38|STANDARD_ERROR_OF_MEAN|0.071||0.0539|TWO_SIDED|95.0|0.99|1.91|||ANOVA|||PDE4A; Placebo vs GSK256066 200 mcg||1.91|0.99|0.0539
72401633|NCT00464568|144310563|SUPERIORITY_OR_OTHER||Treatment Ratios|1.06|STANDARD_ERROR_OF_MEAN|0.081||0.7393|TWO_SIDED|95.0|0.74|1.54|||ANOVA|||RGS1; Placebo vs GSK256066 1 mcg||1.54|0.74|0.7393
72401634|NCT00464568|144310563|SUPERIORITY_OR_OTHER||Treatment Ratios|1.21|STANDARD_ERROR_OF_MEAN|0.08||0.2967|TWO_SIDED|95.0|0.84|1.74|||ANOVA|||RGS1; Placebo vs GSK256066 10 mcg||1.74|0.84|0.2967
72401635|NCT00464568|144310563|SUPERIORITY_OR_OTHER||Treatment Ratios|1.37|STANDARD_ERROR_OF_MEAN|0.081||0.0934|TWO_SIDED|95.0|0.95|1.98|||ANOVA|||RGS1; Placebo vs GSK256066 50 mcg||1.98|0.95|0.0934
72566788|NCT02312713|144664435|SUPERIORITY||Mean Difference (Final Values)|-3.36||||0.06|TWO_SIDED|95.0|-6.84|0.12|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Wait List Control at 4 months.||0.12|-6.84|0.06
72481028|NCT03401229|144488466|SUPERIORITY||Median Difference (Net)|-1.854||||0.0036|TWO_SIDED|95.0|-3.101|-0.608||This endpoint was not a part of the pre-specified testing strategy and was not tested for statistical significance. The p-value was considered nominal.|ANCOVA|ANCOVA following hybrid WP/WOCF and MI (assuming MAR), adjusting for treatment, baseline score, region (US/Non-US) and baseline comorbid asthma status||This endpoint compared the changes from baseline score between benralizumab and placebo. H0: The change from baseline score is similar between benralizumab and placebo. H1: The change from baseline score is different between benralizumab and placebo.||-0.608|-3.101|0.0036
72481029|NCT03401229|144488467|SUPERIORITY||Mean Difference (Net)|-0.166||||0.0941|TWO_SIDED|95.0|-0.36|0.028||This endpoint was not a part of the pre-specified testing strategy and was not tested for statistical significance. The p-value was considered nominal.|ANCOVA|ANCOVA following hybrid WP/WOCF and MI (assuming MAR), adjusting for treatment, baseline score, region (US/Non-US) and baseline comorbid asthma status||This endpoint compared the changes from baseline score between benralizumab and placebo. H0: The change from baseline score is similar between benralizumab and placebo. H1: The change from baseline score is different between benralizumab and placebo.||0.028|-0.360|0.0941
72481030|NCT03401229|144488468|SUPERIORITY||Mean Difference (Net)|-0.213||||0.0246|TWO_SIDED|95.0|-0.399|-0.027||This endpoint was not a part of the pre-specified testing strategy and was not tested for statistical significance. The p-value was considered nominal.|ANCOVA|ANCOVA following hybrid WP/WOCF and MI (assuming MAR), adjusting for treatment, baseline score, region (US/Non-US) and baseline comorbid asthma status||This endpoint compared the changes from baseline score between benralizumab and placebo. H0: The change from baseline score is similar between benralizumab and placebo. H1: The change from baseline score is different between benralizumab and placebo.||-0.027|-0.399|0.0246
72481031|NCT03401229|144488469|SUPERIORITY||Mean Difference (Net)|0.672||||0.5833|TWO_SIDED|95.0|-1.73|3.074||This endpoint was not a part of the pre-specified testing strategy and was not tested for statistical significance. The p-value was considered nominal.|ANCOVA|ANCOVA following hybrid WP/WOCF and MI (assuming MAR), adjusting for treatment, baseline score, region (US/Non-US) and baseline comorbid asthma status||This endpoint compared the changes from baseline score between benralizumab and placebo. H0: The change from baseline score is similar between benralizumab and placebo. H1: The change from baseline score is different between benralizumab and placebo.||3.074|-1.730|0.5833
72481032|NCT03401229|144488470|SUPERIORITY||Median Difference (Net)|2.684||||0.0619|TWO_SIDED|95.0|-0.134|5.502||This endpoint was not a part of the pre-specified testing strategy and was not tested for statistical significance. The p-value was considered nominal.|ANCOVA|ANCOVA following hybrid WP/WOCF and MI (assuming MAR), adjusting for treatment, baseline score, region (US/Non-US) and baseline comorbid asthma status||This endpoint compared the changes from baseline score between benralizumab and placebo. H0: The change from baseline score is similar between benralizumab and placebo. H1: The change from baseline score is different between benralizumab and placebo.||5.502|-0.134|0.0619
72481033|NCT03401229|144488471|SUPERIORITY||Median Difference (Net)|-5.057||||0.102|TWO_SIDED|95.0|-11.129|1.015||This endpoint was not a part of the pre-specified testing strategy and was not tested for statistical significance. The p-value was considered nominal.|ANCOVA|Following WP (WP for NP surgery rescued subjects), model included treatment, baseline score, region (US/Non-US) and baseline comorbid asthma status||This endpoint compared the changes from baseline score between benralizumab and placebo. H0: The change from baseline score is similar between benralizumab and placebo. H1: The change from baseline score is different between benralizumab and placebo.||1.015|-11.129|0.1020
72481034|NCT01122862|144488482|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.21||||0.0915|TWO_SIDED|95.0|-0.45|0.03||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|ANCOVA with factors for treatment, period and subject (random) with baseline as a covariate.|Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.|Null hypothesis was no difference between treatments being compared.||0.03|-0.45|0.0915
72481035|NCT01122862|144488483|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|1.66|||<|0.0001|TWO_SIDED|95.0|1.42|1.9||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|ANCOVA with factors for treatment, period and subject (random) with baseline as a covariate.|Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.|Null hypothesis was no difference in treatments being compared.||1.90|1.42|<0.0001
72401636|NCT00464568|144310563|SUPERIORITY_OR_OTHER||Treatment Ratios|1.37|STANDARD_ERROR_OF_MEAN|0.08||0.0919|TWO_SIDED|95.0|0.95|1.97|||ANOVA|||RGS1; Placebo vs GSK256066 200 mcg||1.97|0.95|0.0919
72481036|NCT01122862|144488484|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.04||||0.6682|TWO_SIDED|95.0|-0.14|0.21|||ANCOVA|ANCOVA with factors for treatment, period and subject (random) with baseline as a covariate.|Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.|Null hypothesis was no difference between treatments being compared.||0.21|-0.14|0.6682
72566789|NCT02312713|144664435|SUPERIORITY||Mean Difference (Final Values)|-1.59||||0.39|TWO_SIDED|95.0|-5.26|2.08|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Wait List Control at 12 months.||2.08|-5.26|0.39
72566790|NCT02312713|144664435|SUPERIORITY||Mean Difference (Final Values)|-2.7||||0.14|TWO_SIDED|95.0|-6.24|0.85|||Mixed Models Analysis|||This is the comparison between Internet Based Exercise Training and Wait List Control at 4 months.||0.85|-6.24|0.14
72401637|NCT00464568|144310563|SUPERIORITY_OR_OTHER||Treatment Ratios|2.72|STANDARD_ERROR_OF_MEAN|0.056|<|0.0001|TWO_SIDED|95.0|2.11|3.51|||ANOVA|||SNF1LK; Placebo vs GSK256066 1 mcg||3.51|2.11|<0.0001
72566791|NCT02312713|144664435|SUPERIORITY||Mean Difference (Final Values)|-2.63||||0.17|TWO_SIDED|95.0|-6.37|1.11|||Mixed Models Analysis|||This is the comparison between Internet Based Exercise Training and Wait List Control at 12 months.||1.11|-6.37|0.17
72566792|NCT02312713|144664435|NON_INFERIORITY|The IBET intervention will be non-inferior to the standard PT intervention, indicated by a mean WOMAC score less than 5 points higher than standard PT.|Mean Difference (Final Values)|0.67||||0.65|TWO_SIDED|95.0|-2.23|3.56|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Internet Based Exercise Training at 4 months.||3.56|-2.23|0.65
72401638|NCT00464568|144310563|SUPERIORITY_OR_OTHER||Treatment Ratios|3.04|STANDARD_ERROR_OF_MEAN|0.055|<|0.0001|TWO_SIDED|95.0|2.37|3.9|||ANOVA|||SNF1LK; Placebo vs GSK256066 10 mcg||3.90|2.37|<0.0001
72401639|NCT00464568|144310563|SUPERIORITY_OR_OTHER||Treatment Ratios|3.28|STANDARD_ERROR_OF_MEAN|0.056|<|0.0001|TWO_SIDED|95.0|2.54|4.23|||ANOVA|||RGS1; Placebo vs GSK256066 50 mcg||4.23|2.54|<0.0001
72401640|NCT00464568|144310563|SUPERIORITY_OR_OTHER||Treatment Ratios|3.32|STANDARD_ERROR_OF_MEAN|0.055|<|0.0001|TWO_SIDED|95.0|2.59|4.27|||ANOVA|||RGS1; Placebo vs GSK256066 200 mcg||4.27|2.59|<0.0001
72401641|NCT00464568|144310578|SUPERIORITY_OR_OTHER||Mean treatment difference|-0.5545|STANDARD_DEVIATION|7.79598||0.647226|||||||Mixed effects analysis of variance model|||Placebo vs GSK256066 1 mcg: VASP||||0.647226
72623962|NCT00608062|144778388|OTHER|Repeated measurements of FMD were modeled using a general linear mixed model with maximum likelihood estimation. An unstructured covariance structure allowing for heterogeneity in the parameter estimate for each level of menopause stage was chosen for the model based on using AIC to compare various covariance structures.||||||0.05|||||||Mixed Models Analysis|||||||0.05
72623963|NCT00608062|144778390|OTHER|Similar analyses as primary outcome||||||0.05|||||||Mixed Models Analysis|||||||0.05
72623964|NCT00608062|144778391|OTHER|same analysis as primary outcome||||||0.05|||||||Mixed Models Analysis|||||||0.05
72401642|NCT00464568|144310578|SUPERIORITY_OR_OTHER||Mean treatment difference|-0.3816|STANDARD_DEVIATION|9.00754||0.95084|||||||Mixed effects analysis of variance model||The mean treatment difference was calculated as treatment minus placebo|Placebo vs GSK256066 10 mcg: VASP||||0.95084
72481037|NCT01122862|144488484|SUPERIORITY_OR_OTHER||Adjusted Mean DIfference|0.74|||<|0.0001|TWO_SIDED|95.0|0.57|0.92||No adjustment for multiple comparisons was made as the primary comparison was pre-defined.|ANCOVA|ANCOVA with factors for treatment, period and subject (random) with baseline as a covariate|Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.|Null hypothesis was no difference between treatments being compared.||0.92|0.57|<0.0001
72481038|NCT01122862|144488485|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.2||||0.11|TWO_SIDED|95.0|-0.44|0.05||No adjustment for multiple comparisons was made as the primary comparison was pre-defined.|ANCOVA|ANCOVA with factors for treatment, period and subject (random) with baseline as a covariate.|Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.|Null hypothesis was no difference between treatments being compared.||0.05|-0.44|0.1100
72481039|NCT01122862|144488485|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|1.68|||<|0.0001|TWO_SIDED|95.0|1.44|1.93||No adjustment for multiple comparisons was made as the primary comparison was pre-defined.|ANCOVA|ANCOVA with factors for treatment, period and subject (random) with baseline as a covariate.|Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.|Null hypothesis was no difference between treatments being compared.||1.93|1.44|<0.0001
72481040|NCT01122862|144488486|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.03||||0.728||95.0|-0.16|0.23||No adjustment for multiple comparisons was made as the primary comparison was pre-defined.|ANCOVA|ANCOVA with factors for treatment, period and subject (random) with baseline as a covariate.|Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.|Null hypothesis was no difference between treatments being compared.||0.23|-0.16|0.7280
72623965|NCT04992065|144778395|SUPERIORITY||Treatment difference|-31.95|||<|0.0001|TWO_SIDED|95.0|-43.02|-20.87|||ANCOVA|||LDL-C percentage change at week 12 from baseline responses were analysed using an analysis of covariance model with randomised treatment and strata as factors and baseline LDL-C as covariate.||-20.87|-43.02|<.0001
72623966|NCT04992065|144778395|SUPERIORITY||Treatment difference|-44.91|||<|0.0001|TWO_SIDED|95.0|-56.04|-33.79|||ANCOVA|||LDL-C percentage change at week 12 from baseline responses were analysed using an analysis of covariance model with randomised treatment and strata as factors and baseline LDL-C as covariate.||-33.79|-56.04|<.0001
72401643|NCT00464568|144310578|SUPERIORITY_OR_OTHER||Mean treatment difference|0.0256|STANDARD_DEVIATION|9.24118||0.53499|||||||Mixed effects analysis of variance model||The mean treatment difference was calculated as treatment minus placebo|Placebo Vs GSK256066 50 mcg: VASP||||0.53499
72401644|NCT00464568|144310578|SUPERIORITY_OR_OTHER||Mean treatment difference|-1.3371|STANDARD_DEVIATION|7.5459||0.81527|||||||Mixed effects analysis of variance model||The mean treatment difference was calculated as treatment minus placebo|Placebo vs GSK256066 200 mcg: VASP||||0.81527
72401645|NCT00464568|144310578|SUPERIORITY_OR_OTHER||Mean treatment difference|-2.8053|STANDARD_DEVIATION|10.88217||0.32998|||||||Mixed effects analysis of variance model||The mean treatment difference was calculated as treatment minus placebo|Placebo Vs GSK256066 1 mcg: pVASP||||0.32998
72401646|NCT00464568|144310578|SUPERIORITY_OR_OTHER||Mean treatment difference|-1.6602|STANDARD_DEVIATION|12.30724||0.65729|||||||Mixed effects analysis of variance model||The mean treatment difference was calculated as treatment minus placebo|Placebo vs GSK256066 10 mcg: pVASP||||0.65729
72623967|NCT04992065|144778395|SUPERIORITY||Treatment difference|-61.83|||<|0.0001|TWO_SIDED|95.0|-72.94|-50.72|||ANCOVA|||LDL-C percentage change at week 12 from baseline responses were analysed using an analysis of covariance model with randomised treatment and strata as factors and baseline LDL-C as covariate.||-50.72|-72.94|<.0001
72623968|NCT04992065|144778395|SUPERIORITY||Treatment difference|33.32|||||TWO_SIDED|95.0|22.16|44.47||||||LDL-C percentage change at week 12 from baseline responses were analysed using an analysis of covariance model with randomised treatment and strata as factors and baseline LDL-C as covariate.||44.47|22.16|
72401647|NCT00464568|144310578|SUPERIORITY_OR_OTHER||Mean treatment difference|0.156|STANDARD_DEVIATION|4.73976||0.89831|||||||Mixed effects analysis of variance model||The mean treatment difference was calculated as treatment minus placebo|Placebo vs GSK256066 50 mcg: pVASP||||0.89831
72401648|NCT00464568|144310578|SUPERIORITY_OR_OTHER||Mean treatment difference|-1.5165|STANDARD_DEVIATION|12.70748||0.84479|||||||Mixed effects analysis of variance model||The mean treatment difference was calculated as treatment minus placebo|Placebo vs GSK256066 200 mcg: pVASP||||0.84479
72481041|NCT01122862|144488486|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.88|||<|0.0001|TWO_SIDED|95.0|0.68|1.08||No adjustment for multiple comparisons was made as the primary comparison was pre-defined.|ANCOVA|ANCOVA with factors for treatment, period and subject (random) with baseline as a covariate|Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.|Null hypothesis was no difference between treatments being compared.||1.08|0.68|<0.0001
72481042|NCT01287065|144488518|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.377|||||TWO_SIDED|90.0|0.293|0.462|||Mixed Models Analysis||Mean difference =FF/VI 100/25 µg PM minus Placebo|||0.462|0.293|
72401649|NCT03615326|144310579|SUPERIORITY|The hazard ratio (HR) and its 95% confidence interval (CI) were estimated using a stratified Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by geographic region, PD-L1 status (positive vs. negative) at baseline, and chemotherapy regimen (FP or CAPOX).|Hazard Ratio (HR)|0.73||||0.0002|TWO_SIDED|95.0|0.61|0.87|||Log Rank|One-sided p-value based on log-rank test stratified by geographic region, PD-L1 status, and chemotherapy regimen with small strata collapsed.|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by geographic region, PD-L1 status, and chemotherapy regimen with small strata collapsed.|PFS in all participants of the Global Pembrolizumab + SOC First Course was compared to PFS in all participants of the Global Standard of Care to address the hypothesis (pembrolizumab in combination with trastuzumab plus chemotherapy is superior to trastuzumab plus chemotherapy alone).||0.87|0.61|0.0002
72401650|NCT03615326|144310580|SUPERIORITY|The hazard ratio (HR) and its 95% confidence interval (CI) were estimated using a stratified Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by geographic region, PD-L1 status (positive vs. negative) at baseline, and chemotherapy regimen (FP or CAPOX).|Hazard Ratio (HR)|0.8||||0.004|TWO_SIDED|95.0|0.67|0.94|||Log Rank|One-sided p-value based on log-rank test stratified by geographic region, PD-L1 status, and chemotherapy regimen with small strata collapsed.|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by geographic region, PD-L1 status, and chemotherapy regimen with small strata collapsed.|OS in all participants of the Global Pembrolizumab + SOC First Course was compared to PFS in all participants of the Global Standard of Care to address the hypothesis (pembrolizumab in combination with trastuzumab plus chemotherapy is superior to trastuzumab plus chemotherapy alone).||0.94|0.67|0.0040
72401651|NCT03615326|144310581|SUPERIORITY|The difference in percentage and its 95% confidence interval (CI) were estimated using the Miettinen \& Nurminen method stratified by geographic region, PD-L1 status (positive vs. negative) at baseline, and chemotherapy regimen (FP or CAPOX).|Difference in Percentage|12.6||||0.0002|TWO_SIDED|95.0|5.6|19.4||One-sided p-value for testing. H0: difference in % = 0 versus H1: difference in % \> 0.|Stratified Miettinen and Nurminen Method|||ORR in all participants of the Global Pembrolizumab + SOC First Course was compared to PFS in all participants of the Global Standard of Care to address the hypothesis (pembrolizumab in combination with trastuzumab plus chemotherapy is superior to trastuzumab plus chemotherapy alone).||19.4|5.6|0.00020
72401652|NCT02864251|144310617|SUPERIORITY||Hazard Ratio (HR)|0.75||||0.0528|TWO_SIDED|95.0|0.56|1.0||Log-rank test stratified by PD-L1 expression (\>= 1% vs \<1%/indeterminate/not evaluable), brain metastases (presence vs absence), smoking history (current/former vs never smoker), and prior osimertinib use (yes vs no) from IRT.|Log Rank||Arm A over Arm C Stratified Cox proportional hazard model.|||1.00|0.56|0.0528
72401653|NCT02864251|144310617|SUPERIORITY||Hazard Ratio (HR)|2.07|||||TWO_SIDED|95.0|1.43|2.99|||||Arm B over Arm C Stratified Cox proportional hazard model.|||2.99|1.43|
72401654|NCT02864251|144310618|SUPERIORITY||Hazard Ratio (HR)|0.83||||0.218|TWO_SIDED|95.0|0.62|1.12|||Log Rank||Hazard Ratio (Arm A over Arm C) is based on a stratified Cox proportional hazard model|||1.12|0.62|0.2180
72401655|NCT02864251|144310618|SUPERIORITY||Hazard Ratio (HR)|1.06|||||TWO_SIDED|95.0|0.75|1.52|||||Hazard Ratio (Arm B over Arm C) is based on a stratified Cox proportional hazard model.|||1.52|0.75|
72401656|NCT02864251|144310619|SUPERIORITY||Odds Ratio (OR)|1.27|||||TWO_SIDED|95.0|0.75|2.16|||||Strata adjusted odds ratio (Arm A over Arm C) using Mantel-Haenszel method.|||2.16|0.75|
72623969|NCT04992065|144778395|SUPERIORITY||Treatment difference|20.35|||||TWO_SIDED|95.0|9.21|31.48||||||LDL-C percentage change at week 12 from baseline responses were analysed using an analysis of covariance model with randomised treatment and strata as factors and baseline LDL-C as covariate.||31.48|9.21|
72401657|NCT00885755|144310634|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.41|||||TWO_SIDED|95.0|0.109|1.535||||||Univariate Cox regression Hazard ratio (Positive / Negative) for the biomarker p95.||1.535|0.109|
72401658|NCT00885755|144310634|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.19|||||TWO_SIDED|95.0|0.43|3.282||||||Univariate Cox regression: Hazard ratio (Membrane H-Score: \<median / ≥median) for the biomarker IGF1R.||3.282|0.430|
72481043|NCT01287065|144488518|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.422|||||TWO_SIDED|90.0|0.337|0.507|||Mixed Models Analysis||Mean difference =FF/VI 100/25 µg AM minus Placebo|||0.507|0.337|
72481044|NCT01287065|144488518|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.044|||||TWO_SIDED|90.0|-0.125|0.036|||Mixed Models Analysis||Mean difference =FF/VI 100/25 µg AM minusFF/VI 100/25 µg PM|||0.036|-0.125|
72401659|NCT00885755|144310634|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.86|||||TWO_SIDED|95.0|0.306|2.425||||||Univariate Cox regression Hazard ratio (Membrane H-Score: \<median / ≥median) for the biomarker c-MET.||2.425|0.306|
72401660|NCT00885755|144310634|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.49|||||TWO_SIDED|95.0|0.164|1.453||||||Univariate Cox regression Hazard ratio (Cytoplasm H-Score: \<median / ≥median) for the biomarker PTEN.||1.453|0.164|
72401661|NCT00885755|144310634|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.09|||||TWO_SIDED|95.0|0.377|3.16||||||Univariate Cox regression Hazard ratio (Membrane H-Score: \< median / ≥median) for the biomarker HER2.||3.160|0.377|
72481045|NCT02875977|144488522|SUPERIORITY||Odds Ratio (OR)|1.794||||0.17|TWO_SIDED|95.0|0.782|4.119|||Regression, Logistic|||The null hypothesis is that there is no difference in the odds of completing half of the recommended PFPT visits between those assigned to standard versus experimental counseling||4.119|0.782|0.17
72623970|NCT04992065|144778395|SUPERIORITY||Treatment difference|3.43|||||TWO_SIDED|95.0|-7.81|14.68||||||LDL-C percentage change at week 12 from baseline responses were analysed using an analysis of covariance model with randomised treatment and strata as factors and baseline LDL-C as covariate.||14.68|-7.81|
72623971|NCT00663260|144778404|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.08|STANDARD_ERROR_OF_MEAN|0.1448||0.561|TWO_SIDED|95.0|-0.37|0.2||Primary endpoints were tested at alpha=0.027 applying Dunnett's adjustment|ANCOVA|||||0.20|-0.37|0.561
72401662|NCT00885755|144310634|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.3|||||TWO_SIDED|95.0|0.409|4.132||||||Univariate Cox regression Hazard ratio (Mutation Status: Wild type / Mutation) for the biomarker PI3K amino acids.||4.132|0.409|
72401663|NCT00885755|144310634|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.183|||||TWO_SIDED|95.0|0.226|6.197||||||Univariate Cox regression Hazard ratio (Phenotype: FF / VF) for the biomarker FC Gamma Receptor IIIa F176V.||6.197|0.226|
72401664|NCT00885755|144310634|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.989|||||TWO_SIDED|95.0|0.378|10.47||||||Univariate Cox regression Hazard ratio (Phenotype: FF / VV) for the biomarker FC Gamma Receptor IIIa F176V.||10.470|0.378|
72401665|NCT00885755|144310634|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.732|||||TWO_SIDED|95.0|0.235|12.783||||||Univariate Cox regression Hazard ratio (Phenotype: VF / VV) for the biomarker FC Gamma Receptor IIIa F176V.||12.783|0.235|
72401666|NCT00885755|144310634|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.576|||||TWO_SIDED|95.0|0.067|4.968||||||Univariate Cox regression Hazard ratio (Phenotype: HH / HR) for the biomarker FC Gamma Receptor IIa R166H.||4.968|0.067|
72401667|NCT00885755|144310634|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.743|||||TWO_SIDED|95.0|0.082|6.72||||||Univariate Cox regression Hazard ratio (Phenotype: HH / RR) for the biomarker FC Gamma Receptor IIa R166H.||6.720|0.082|
72401668|NCT00885755|144310634|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.073|||||TWO_SIDED|95.0|0.274|4.199||||||Univariate Cox regression Hazard ratio (Phenotype: HR / RR) for the biomarker FC Gamma Receptor IIa R166H.||4.199|0.274|
72401669|NCT00885755|144310637|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.46|||||TWO_SIDED|95.0|0.12|1.79||||||Univariate Cox regression Hazard ratio (Positive / Negative) for the biomarker p95 HER2.||1.790|0.120|
72401670|NCT00885755|144310637|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.18|||||TWO_SIDED|95.0|0.394|3.518||||||Univariate Cox regressionHazard ratio (Membrane H-Score: \<median / ≥median) for the biomarker IGF1R.||3.518|0.394|
72401671|NCT00885755|144310637|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.82|||||TWO_SIDED|95.0|0.268|2.514||||||Univariate Cox regression Hazard ratio (Membrane H-Score: \< median / ≥median) for the biomarker c-met.||2.514|0.268|
72401672|NCT00885755|144310637|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.57|||||TWO_SIDED|95.0|0.183|1.768||||||Univariate Cox regression Hazard ratio (Cytoplasm H-Score: \< median / ≥median) for the marker PTEN.||1.768|0.183|
72401673|NCT00885755|144310637|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.81|||||TWO_SIDED|95.0|0.242|2.733||||||Univariate Cox regression Hazard ratio (Membrane H-Score: \< median / ≥median) for the biomarker HER2.||2.733|0.242|
72401674|NCT00885755|144310637|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.11|||||TWO_SIDED|95.0|0.337|3.632||||||Univariate Cox regressionHazard ratio (Mutation Status: Wild type / Mutation) for the biomarker PI3K amino acids.||3.632|0.337|
72401675|NCT00885755|144310637|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.957|||||TWO_SIDED|95.0|0.172|5.336||||||Hazard ratio (Phenotype: FF / VF) for the biomarker FC Gamma Receptor IIIa F176V.||5.336|0.172|
72401676|NCT00885755|144310637|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.666|||||TWO_SIDED|95.0|0.298|9.305||||||Hazard ratio (Phenotype: FF / VV) for the biomarker FC Gamma Receptor IIIa F176V.||9.305|0.298|
72401677|NCT00885755|144310637|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.732|||||TWO_SIDED|95.0|0.235|12.783||||||Hazard ratio (Phenotype: VF / VV) for the biomarker FC Gamma Receptor IIIa F176V.||12.783|0.235|
72401678|NCT00885755|144310637|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.576|||||TWO_SIDED|95.0|0.067|4.968||||||Univariate Cox regression Hazard ratio (Phenotype: HH / HR) for the biomarker FC Gamma Receptor IIa R166H.||4.968|0.067|
72401679|NCT00885755|144310637|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.956|||||TWO_SIDED|95.0|0.098|9.319||||||Univariate Cox regression Hazard ratio (Phenotype: HH / RR) for the biomarker FC Gamma Receptor IIa R166H.||9.319|0.098|
72401680|NCT00885755|144310637|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.292|||||TWO_SIDED|95.0|0.296|5.64||||||Univariate Cox regression Hazard ratio (Phenotype: HR / RR) for the biomarker FC Gamma Receptor IIa R166H.||5.640|0.296|
72401681|NCT00885755|144310645|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.03|||||TWO_SIDED|95.0|0.001|0.641||||||Univariate logistic regression Odds ratio (Positive / Negative) for the biomarker p95 HER 2.||0.641|0.001|
72401682|NCT00885755|144310645|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.208|||||TWO_SIDED|95.0|0.017|2.6||||||Univariate logistic regression Odds ratio (Membrane H-Score: ≥median /\<median) for the biomarker IGF1R.||2.600|0.017|
72401683|NCT00885755|144310645|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.143|||||TWO_SIDED|95.0|0.169|27.103||||||Univariate logistic regression Odds ratio (Membrane H-Score: ≥ median /\<median) for the biomarker c-MET.||27.103|0.169|
72401684|NCT00885755|144310645|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.875|||||TWO_SIDED|95.0|0.15|23.396||||||Univariate logistic regression Odds ratio (Cytoplasm H-Score: ≥ median /\< median) for the biomarker PTEN.||23.396|0.150|
72401685|NCT00885755|144310645|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.857|||||TWO_SIDED|95.0|0.091|8.075||||||Univariate logistic regression Odds ratio (Membrane H-Score: ≥median /\< median) for the biomarker HER2.||8.075|0.091|
72401686|NCT00885755|144310645|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.148|||||TWO_SIDED|95.0|0.012|1.9||||||Univariate logistic regression Odds ratio (PI3K mutation status: WT versus M) for the biomarker PI3K Amino Acids.||1.900|0.012|
72401687|NCT00885755|144310645|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.0|||||TWO_SIDED|95.0|0.053|18.915||||||Univariate logistic regressionOdds ratio (Phenotype: FF / VF) for the biomarker FC Gamma Receptor IIIa F176V.||18.915|0.053|
72401688|NCT00885755|144310645|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.083|||||TWO_SIDED|95.0|0.004|1.945||||||Univariate logistic regression Odds ratio (Phenotype: HR / RR) for the biomarker FC Gamma Receptor IIa R166H||1.945|0.004|
72401689|NCT01549964|144310677|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.55|STANDARD_ERROR_OF_MEAN|0.108|<|0.001|TWO_SIDED|95.0|-0.77|-0.34||MMRM model with treatment, country, schedule, visit and visit by treatment interaction as fixed factors and with baseline value and baseline value by visit interaction as covariates with an unstructured covariance structure.|Mixed model for repeated measurements|||||-0.34|-0.77|<0.001
72401690|NCT01549964|144310677|SUPERIORITY_OR_OTHER||LS Mean Difference|0.32|STANDARD_ERROR_OF_MEAN|0.087|<|0.001|TWO_SIDED|95.0|0.15|0.49||MMRM model with treatment, country, schedule, visit and visit by treatment interaction as fixed factors and with baseline value and baseline value by visit interaction as covariates with an unstructured covariance structure.|Mixed model for repeated measurements|||||0.49|0.15|<0.001
72481046|NCT02875977|144488523|SUPERIORITY||Odds Ratio (OR)|0.564||||0.056|TWO_SIDED|95.0|0.314|1.014|||Regression, Logistic|||The null hypothesis is that there is no difference in the odds of initiating PFPT between those assigned to standard versus experimental counseling||1.014|0.314|0.056
72481047|NCT02875977|144488524|SUPERIORITY||Odds Ratio (OR)|1.044||||0.9|TWO_SIDED|95.0|0.517|2.11|||Regression, Logistic|The statistical test of the hypothesis excludes the three individuals with unknown PFPT discharge status||The null hypothesis is that there is no difference in the odds of discharge from PFPT between those assigned to standard versus experimental counseling||2.110|0.517|0.90
72481048|NCT02875977|144488525|SUPERIORITY||Z-Score|-1.4262||||0.16|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Among those who initiated PFPT therapy, the null hypothesis is that there is no difference in the number of days to initiating PFPT therapy between those assigned to standard versus experimental counseling||||0.16
72481049|NCT02875977|144488526|SUPERIORITY||Mean Difference (Final Values)|-4.456|STANDARD_ERROR_OF_MEAN|6.5481||0.5|TWO_SIDED|95.0|-17.6149|8.7028|||t-test, 2 sided|||The null hypothesis is that there is no difference in the change from pre-PFPT to post-PFPT UDI-6 scores between those assigned to standard versus experimental counseling||8.7028|-17.6149|0.50
72481050|NCT01259726|144488528|SUPERIORITY_OR_OTHER_LEGACY||||||<=|0.0001|TWO_SIDED|||||Treatment comparison with placebo using two-sided Chi-Square test at significance level p=0.05.|Chi-squared|||||||<=0.0001
72481051|NCT01259726|144488528|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED|||||Treatment comparison with placebo using two-sided Chi-Square test at significance level p=0.05.|Chi-squared|||||||<0.0001
72566793|NCT02312713|144664435|NON_INFERIORITY|The IBET intervention will be non-inferior to the standard PT intervention, indicated by a mean WOMAC score less than 5 points higher than standard PT.|Mean Difference (Final Values)|-1.04||||0.51|TWO_SIDED|95.0|-4.13|2.05|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Internet-Based Exercise Training at 12 months.||2.05|-4.13|0.51
72401691|NCT01549964|144310677|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.82|STANDARD_ERROR_OF_MEAN|0.109|<|0.001|TWO_SIDED|95.0|-1.03|-0.6||MMRM model with treatment, country, schedule, visit and visit by treatment interaction as fixed factors and with baseline value and baseline value by visit interaction as covariates with an unstructured covariance structure.|Mixed model for repeated measurements|||||-0.60|-1.03|<0.001
72401692|NCT01549964|144310677|SUPERIORITY_OR_OTHER||LS Mean Difference|0.06|STANDARD_ERROR_OF_MEAN|0.087||0.524|TWO_SIDED|95.0|-0.12|0.23||MMRM model with treatment, country, schedule, visit and visit by treatment interaction as fixed factors and with baseline value and baseline value by visit interaction as covariates with an unstructured covariance structure.|Mixed model for repeated measurements|||||0.23|-0.12|0.524
72401693|NCT01549964|144310678|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.25||||0.05|TWO_SIDED|95.0|1.0|5.08||P-Value was obtained from a logistic model with treatment, schedule, baseline HbA1c as explanatory variables.|Regression, Logistic|||||5.08|1.00|0.050
72401694|NCT01549964|144310678|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.39|||<|0.001|TWO_SIDED|95.0|0.23|0.67||P-Value was obtained from a logistic model with treatment, schedule, baseline HbA1c as explanatory variables.|Regression, Logistic|||||0.67|0.23|<0.001
72481052|NCT01259726|144488528|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED|||||Treatment comparison with placebo using two-sided Chi-Square test at significance level p=0.05.|Chi-squared|||||||<0.0001
72481053|NCT01259726|144488529|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.088|TWO_SIDED|||||Treatment comparison with placebo using two-sided Chi-Square test at significance level p=0.05.|Chi-squared|||||||=0.088
72481054|NCT01259726|144488529|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.002|TWO_SIDED|||||Treatment comparison with placebo using two-sided Chi-Square test at significance level p=0.05.|Chi-squared|||||||=0.002
72481055|NCT01259726|144488529|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.088|TWO_SIDED|||||Treatment comparison with placebo using two-sided Chi-Square test at significance level p=0.05.|Chi-squared|||||||=0.088
72481056|NCT01259726|144488530|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.054|TWO_SIDED|||||Treatment comparison with placebo using two-sided Chi-Square test at significance level p=0.05.|Chi-squared|||||||=0.054
72401695|NCT01549964|144310678|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.06|||<|0.001|TWO_SIDED|95.0|2.24|11.42||P-Value was obtained from a logistic model with treatment, schedule, baseline HbA1c as explanatory variables.|Regression, Logistic|||||11.42|2.24|<0.001
72401696|NCT01549964|144310678|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.84||||0.493|TWO_SIDED|95.0|0.5|1.39||P-Value was obtained from a logistic model with treatment, schedule, baseline HbA1c as explanatory variables.|Regression, Logistic|||||1.39|0.50|0.493
72481057|NCT01259726|144488530|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.008|TWO_SIDED|||||Treatment comparison with placebo using two-sided Chi-Square test at significance level p=0.05.|Chi-squared|||||||=0.008
72481058|NCT01259726|144488530|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.101|TWO_SIDED|||||Treatment comparison with placebo using two-sided Chi-Square test at significance level p=0.05.|Chi-squared|||||||=0.101
72481059|NCT01259726|144488531|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.045|TWO_SIDED|||||Treatment comparison with placebo using two-sided Chi-Square test at significance level p=0.05.|Chi-squared|||||||=0.045
72481060|NCT01259726|144488531|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.066|TWO_SIDED|||||Treatment comparison with placebo using two-sided Chi-Square test at significance level p=0.05.|Chi-squared|||||||=0.066
72481061|NCT01259726|144488531|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.045|TWO_SIDED|||||Treatment comparison with placebo using two-sided Chi-Square test at significance level p=0.05.|Chi-squared|||||||=0.045
72481062|NCT03421431|144488533|SUPERIORITY||Least Squares (LS) mean difference|12.46||||0.0495|TWO_SIDED|95.0|0.029|24.891|||ANCOVA|||||24.891|0.029|0.0495
72481063|NCT03421431|144488533|SUPERIORITY||LS mean difference|6.257||||0.3039|TWO_SIDED|95.0|-5.754|18.268|||ANCOVA|||||18.268|-5.754|0.3039
72481064|NCT03421431|144488533|SUPERIORITY||LS mean difference|6.203||||0.213|TWO_SIDED|95.0|-3.615|16.021|||ANCOVA|||||16.021|-3.615|0.2130
72481065|NCT03421431|144488534|SUPERIORITY||LS mean difference|4.717||||0.0009|TWO_SIDED|95.0|1.98|7.455|||ANCOVA|||||7.455|1.980|0.0009
72481066|NCT03421431|144488534|SUPERIORITY||LS mean difference|0.934||||0.4946|TWO_SIDED|95.0|-1.766|3.635|||ANCOVA|||||3.635|-1.766|0.4946
72481067|NCT03421431|144488534|SUPERIORITY||LS mean difference|3.783||||0.0005|TWO_SIDED|95.0|1.708|5.858|||ANCOVA|||||5.858|1.708|0.0005
72481068|NCT03421431|144488535|SUPERIORITY||LS mean difference|0.076||||0.2756|TWO_SIDED|95.0|-0.062|0.214|||ANCOVA|||||0.214|-0.062|0.2756
72401697|NCT01549964|144310679|SUPERIORITY_OR_OTHER||LS Mean Difference|-25.2|STANDARD_ERROR_OF_MEAN|4.36|<|0.001|TWO_SIDED|95.0|-33.8|-16.6||MMRM model with treatment, country, schedule, visit and visit by treatment interaction as fixed factors and with baseline value and baseline value by visit interaction as covariates with an unstructured covariance structure.|Mixed model for repeated measurements|||||-16.6|-33.8|<0.001
72481069|NCT03421431|144488535|SUPERIORITY||LS mean difference|-0.003||||0.9686|TWO_SIDED|95.0|-0.136|0.131|||ANCOVA|||||0.131|-0.136|0.9686
72481070|NCT03421431|144488535|SUPERIORITY||LS mean difference|0.079||||0.1406|TWO_SIDED|95.0|-0.026|0.184|||ANCOVA|||||0.184|-0.026|0.1406
72481071|NCT03421431|144488536|SUPERIORITY||LS mean difference|-0.125||||0.613|TWO_SIDED|95.0|-0.613|0.363|||ANCOVA|||||0.363|-0.613|0.6130
72481072|NCT03421431|144488536|SUPERIORITY||LS mean difference|-0.049||||0.8366|TWO_SIDED|95.0|-0.521|0.423|||ANCOVA|||||0.423|-0.521|0.8366
72401698|NCT01549964|144310679|SUPERIORITY_OR_OTHER||LS Mean Difference|-5.1|STANDARD_ERROR_OF_MEAN|3.49||0.142|TWO_SIDED|95.0|-12.0|1.7||MMRM model with treatment, country, schedule, visit and visit by treatment interaction as fixed factors and with baseline value and baseline value by visit interaction as covariates with an unstructured covariance structure.|Mixed model for repeated measurements|||||1.7|-12.0|0.142
72566794|NCT02312713|144664436|SUPERIORITY||Median Difference (Final Values)|0.56||||0.01|TWO_SIDED|95.0|0.15|0.98|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Wait List Control at 4 months.||0.98|0.15|0.01
72401699|NCT01549964|144310679|SUPERIORITY_OR_OTHER||LS Mean Difference|-31.3|STANDARD_ERROR_OF_MEAN|4.4|<|0.001|TWO_SIDED|95.0|-39.9|-22.6||MMRM model with treatment, country, schedule, visit and visit by treatment interaction as fixed factors and with baseline value and baseline value by visit interaction as covariates with an unstructured covariance structure.|Mixed model for repeated measurements|||||-22.6|-39.9|<0.001
72401700|NCT01549964|144310679|SUPERIORITY_OR_OTHER||Least Square Mean difference|-11.2|STANDARD_ERROR_OF_MEAN|3.53||0.002|TWO_SIDED|95.0|-18.1|-4.2||MMRM model with treatment, country, schedule, visit and visit by treatment interaction as fixed factors and with baseline value and baseline value by visit interaction as covariates with an unstructured covariance structure.|Mixed model for repeated measurements|||||-4.2|-18.1|0.002
72401701|NCT02438722|144310681|SUPERIORITY||Hazard Ratio (HR)|0.82||||0.44|TWO_SIDED|95.0|0.5|1.36|||Log Rank|||||1.36|0.50|0.44
72481073|NCT03421431|144488536|SUPERIORITY||LS mean difference|-0.076||||0.7015|TWO_SIDED|95.0|-0.466|0.315|||ANCOVA|||||0.315|-0.466|0.7015
72481074|NCT03421431|144488537|SUPERIORITY||LS mean difference|-0.186||||0.3875|TWO_SIDED|95.0|-0.613|0.24|||ANCOVA|||||0.240|-0.613|0.3875
72481075|NCT03421431|144488537|SUPERIORITY||LS mean difference|-0.248||||0.2331|TWO_SIDED|95.0|-0.657|0.162|||ANCOVA|||||0.162|-0.657|0.2331
72481076|NCT03421431|144488537|SUPERIORITY||LS mean difference|0.061||||0.7164|TWO_SIDED|95.0|-0.272|0.395|||ANCOVA|||||0.395|-0.272|0.7164
72481077|NCT03421431|144488538|SUPERIORITY||LS mean difference|0.21|||<|0.0001|TWO_SIDED|95.0|0.11|0.311|||ANCOVA|||||0.311|0.110|<0.0001
72481078|NCT03421431|144488538|SUPERIORITY||LS mean difference|0.046||||0.348|TWO_SIDED|95.0|-0.051|0.143|||ANCOVA|||||0.143|-0.051|0.3480
72401702|NCT02438722|144310682|SUPERIORITY||Hazard Ratio (HR)|1.01||||0.94|TWO_SIDED|95.0|0.72|1.43|||Log Rank|||||1.43|0.72|0.94
72401703|NCT02438722|144310684|SUPERIORITY||Hazard Ratio (HR)|0.9||||0.54|TWO_SIDED|95.0|0.64|1.26|||Log Rank|||||1.26|0.64|0.54
72481079|NCT03421431|144488538|SUPERIORITY||LS mean difference|0.164|||<|0.0001|TWO_SIDED|95.0|0.085|0.243|||ANCOVA|||||0.243|0.085|<0.0001
72481080|NCT03421431|144488539|SUPERIORITY||LS mean difference|-0.299||||0.0897|TWO_SIDED|95.0|-0.645|0.047|||ANCOVA|||||0.047|-0.645|0.0897
72481081|NCT03421431|144488539|SUPERIORITY||LS mean difference|-0.251||||0.1411|TWO_SIDED|95.0|-0.586|0.085|||ANCOVA|||||0.085|-0.586|0.1411
72481082|NCT03421431|144488539|SUPERIORITY||LS mean difference|-0.048||||0.733|TWO_SIDED|95.0|-0.326|0.23|||ANCOVA|||||0.230|-0.326|0.7330
72481083|NCT03421431|144488540|SUPERIORITY||LS mean difference|51.873||||0.9143|TWO_SIDED|95.0|-901.574|1005.32|||ANCOVA|||||1005.320|-901.574|0.9143
72481084|NCT03421431|144488540|SUPERIORITY||LS mean difference|404.168||||0.3718|TWO_SIDED|95.0|-489.519|1297.854|||ANCOVA|||||1297.854|-489.519|0.3718
72481085|NCT03421431|144488540|SUPERIORITY||LS mean difference|-352.295||||0.3466|TWO_SIDED|95.0|-1091.308|386.719|||ANCOVA|||||386.719|-1091.308|0.3466
72481086|NCT03421431|144488541|SUPERIORITY||LS mean difference|0.173||||0.0003|TWO_SIDED|95.0|0.081|0.264|||ANCOVA|||||0.264|0.081|0.0003
72401704|NCT02438722|144310685|SUPERIORITY||Hazard Ratio (HR)|1.01||||0.95|TWO_SIDED|95.0|0.73|1.39|||Log Rank|||||1.39|0.73|0.95
72481087|NCT03421431|144488541|SUPERIORITY||LS mean difference|0.025||||0.5685|TWO_SIDED|95.0|-0.062|0.113|||ANCOVA|||||0.113|-0.062|0.5685
72481088|NCT03421431|144488541|SUPERIORITY||LS mean difference|0.147|||<|0.0001|TWO_SIDED|95.0|0.075|0.219|||ANCOVA|||||0.219|0.075|<0.0001
72481089|NCT03421431|144488542|SUPERIORITY||LS mean difference|-0.133||||0.0282|TWO_SIDED|95.0|-0.252|-0.015|||ANCOVA|||||-0.015|-0.252|0.0282
72481090|NCT03421431|144488542|SUPERIORITY||LS mean difference|-0.068||||0.2412|TWO_SIDED|95.0|-0.182|0.046|||ANCOVA|||||0.046|-0.182|0.2412
72481091|NCT03421431|144488542|SUPERIORITY||LS mean difference|-0.066||||0.1649|TWO_SIDED|95.0|-0.158|0.027|||ANCOVA|||||0.027|-0.158|0.1649
72481092|NCT03421431|144488543|SUPERIORITY||LS mean difference|0.009||||0.4357|TWO_SIDED|95.0|-0.014|0.032|||ANCOVA|||||0.032|-0.014|0.4357
72481093|NCT03421431|144488543|SUPERIORITY||LS mean difference|0.001||||0.8989|TWO_SIDED|95.0|-0.021|0.023|||ANCOVA|||||0.023|-0.021|0.8989
72481094|NCT03421431|144488543|SUPERIORITY||LS mean difference|0.008||||0.412|TWO_SIDED|95.0|-0.011|0.026|||ANCOVA|||||0.026|-0.011|0.4120
72481095|NCT03421431|144488544|SUPERIORITY||LS mean difference|-1.731||||0.0134|TWO_SIDED|95.0|-3.095|-0.368|||ANCOVA|||||-0.368|-3.095|0.0134
72481096|NCT03421431|144488544|SUPERIORITY||LS mean difference|-0.327||||0.6263|TWO_SIDED|95.0|-1.656|1.001|||ANCOVA|||||1.001|-1.656|0.6263
72481097|NCT03421431|144488544|SUPERIORITY||LS mean difference|-1.404||||0.0115|TWO_SIDED|95.0|-2.487|-0.322|||ANCOVA|||||-0.322|-2.487|0.0115
72566795|NCT02312713|144664436|SUPERIORITY||Mean Difference (Final Values)|0.23||||0.28|TWO_SIDED|95.0|-0.19|0.65|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Wait List Control at 12 months.||0.65|-0.19|0.28
72401705|NCT00909779|144310693|NON_INFERIORITY_OR_EQUIVALENCE|"The study was powered under a one-sided alternative hypothesis, in which arformoterol is superior to placebo, with a hazard ratio of 0.80 or less. To achieve 80% power, it was necessary to observe 86 total events for the primary endpoint adjusted for interim analysis. Assuming an annual event proportion of 17.3% in the placebo group and 30% lost to follow-up, we anticipated to randomize approximately 900 subjects (450 per arm).~The non-inferiority margin for the hazard ratio is 1.4."|Hazard Ratio (HR)|0.606|||||TWO_SIDED|95.0|0.425|0.864|||Regression, Cox||Hazard ratio was calculated as arformoterol vs. placebo.|"The null hypothesis is: There is 40% or higher excess risk of the primary events in the arformoterol group relative to placebo (a constant hazard ratio of 1.4).~The primary analysis was a Cox proportional hazards regression model, with treatment group, baseline smoking status, sex, age, BMI, and baseline FEV1 as covariates. The hazard ratio and 90% two-sided confidence interval for the hazard ratio (adjusted for the interim analysis) comparing arformoterol to placebo were estimated."||0.864|0.425|
72401706|NCT02449174|144310702|SUPERIORITY|||||||0.8958|||||||Chi-squared, Corrected|||||||0.8958
72401707|NCT02449174|144310703|SUPERIORITY|||||||0.2059|||||||Chi-squared, Corrected|||||||0.2059
72401708|NCT01520363|144310716|SUPERIORITY||Mean Difference (Net)|-1.182|STANDARD_DEVIATION|4.294||0.211|TWO_SIDED|95.0|-3.086|0.722|||t-test, 2 sided|df=21|||t= -1.291; p=.211|.722|-3.086|.211
72401709|NCT01520363|144310716|SUPERIORITY||Median Difference (Final Values)|0.043|STANDARD_ERROR_OF_MEAN|0.67||0.949|TWO_SIDED|95.0|-1.345|1.432|||t-test, 2 sided|df=22||||1.432|-1.345|.949
72401710|NCT01520363|144310717|SUPERIORITY||Mean Difference (Final Values)|0.333|STANDARD_DEVIATION|2.456||0.541|TWO_SIDED|95.0|-0.785|1.451||df=20|t-test, 2 sided|df=20|||t=0.622; p=.541|1.451|-0.785|.541
72401711|NCT01520363|144310717|SUPERIORITY||Mean Difference (Net)|-0.042|STANDARD_DEVIATION|2.956||0.946|TWO_SIDED|95.0|-1.29|1.206||df=23|t-test, 2 sided||||t=-.069; p=0.946|1.206|-1.290|.946
72401712|NCT01520363|144310718|SUPERIORITY||Mean Difference (Net)|-0.227|STANDARD_DEVIATION|3.116||0.736|TWO_SIDED|95.0|-1.609|1.154|||t-test, 2 sided|df=21|||t=-0.342; p=0.736|1.154|-1.609|.736
72401713|NCT01520363|144310718|SUPERIORITY||Mean Difference (Net)|0.409|STANDARD_DEVIATION|3.5||0.589|TWO_SIDED|95.0|-1.143|1.961|||t-test, 2 sided||||t=0.548; p=0.589|1.961|-1.143|.589
72401714|NCT01520363|144310719|SUPERIORITY||Mean Difference (Net)|-1.429|STANDARD_DEVIATION|3.203||0.05|TWO_SIDED|95.0|-2.886|0.029|||t-test, 2 sided|df=20|||t=-2.044; p=0.05|0.029|-2.886|.05
72401715|NCT01520363|144310719|SUPERIORITY||Mean Difference (Net)|0.042|STANDARD_DEVIATION|3.862||0.958|TWO_SIDED|95.0|-1.589|1.672|||t-test, 2 sided||||t=0.053; p=0.958|1.672|-1.589|0.958
72401716|NCT01520363|144310720|SUPERIORITY||Median Difference (Net)|0.227|STANDARD_DEVIATION|1.51||0.488|TWO_SIDED|95.0|-0.442|0.897|||t-test, 2 sided|df=21|||t=0.706; p=0.488|0.897|-0.442|0.488
72401717|NCT01520363|144310720|SUPERIORITY||Median Difference (Net)|0.24|STANDARD_DEVIATION|1.535||0.442|TWO_SIDED|95.0|-0.394|0.874|||t-test, 2 sided|df=24|||t=0.782; p=0.442|0.874|-0.394|0.442
72401718|NCT01520363|144310721|SUPERIORITY||Mean Difference (Net)|0.682|STANDARD_DEVIATION|2.317||0.182|TWO_SIDED|95.0|-0.346|1.709|||t-test, 2 sided|df=21|||t=1.380; p=0.182|1.709|-0.346|0.182
72401719|NCT01520363|144310721|SUPERIORITY||Mean Difference (Net)|1.16|STANDARD_DEVIATION|1.864|<|0.005|TWO_SIDED|95.0|0.391|1.929|||t-test, 2 sided|df=24|||t=3.112; p=0.005|1.929|0.391|<0.005
72401720|NCT01520363|144310722|SUPERIORITY||Mean Difference (Net)|0.091|STANDARD_DEVIATION|3.504||0.9|TWO_SIDED|95.0|-1.463|1.644|||t-test, 2 sided||||t=0.122; p=0.90|1.644|-1.463|0.90
72566796|NCT02312713|144664436|SUPERIORITY||Mean Difference (Final Values)|0.07||||0.75|TWO_SIDED|95.0|-0.35|0.49|||Mixed Models Analysis|||This is the comparison between Internet Based Exercise Training and Wait List Control at 4 months.||0.49|-0.35|0.75
72401721|NCT01520363|144310722|SUPERIORITY||Mean Difference (Net)|0.48|STANDARD_DEVIATION|2.551||0.356|TWO_SIDED|95.0|-0.573|1.533|||t-test, 2 sided|df=24|||t=0.941; p=0.356|1.533|-0.573|0.356
72401722|NCT01520363|144310723|SUPERIORITY||Mean Difference (Net)|0.136|STANDARD_DEVIATION|3.06||0.836|TWO_SIDED|95.0|-1.22|1.493|||t-test, 2 sided||||t=0.209; p=0.836|1.493|-1.220|0.836
72401723|NCT01520363|144310723|SUPERIORITY||Mean Difference (Net)|0.12|STANDARD_DEVIATION|2.698||0.826|TWO_SIDED|95.0|-0.993|1.233|||t-test, 2 sided|df=24|||t=0.222; p=0.826|1.233|-0.993|0.826
72401724|NCT01520363|144310724|SUPERIORITY||Mean Difference (Net)|-3.38|STANDARD_ERROR_OF_MEAN|4.18||0.42|TWO_SIDED|95.0|-11.8|5.05|||t-test, 2 sided|||||5.05|-11.80|0.42
72401725|NCT01520363|144310725|SUPERIORITY||Mean Difference (Net)|-1.03|STANDARD_ERROR_OF_MEAN|2.97|<|0.73|TWO_SIDED|95.0|-7.02|4.96|||t-test, 2 sided|||||4.96|-7.02|<0.73
72401726|NCT01520363|144310726|SUPERIORITY||Mean Difference (Net)|8.4615|STANDARD_DEVIATION|32.8016||0.371|TWO_SIDED|95.0|-11.3603|28.2834|||t-test, 2 sided|df=12|||t=0.903; p=0.371|28.2834|-11.3603|0.371
72566797|NCT02312713|144664436|SUPERIORITY||Mean Difference (Final Values)|0.27||||0.22|TWO_SIDED|95.0|-0.16|0.7|||Mixed Models Analysis|||This is the comparison between Internet Based Exercise Training and Wait List Control at 12 months.||0.7|-0.16|0.22
72401727|NCT01520363|144310726|SUPERIORITY||Mean Difference (Net)|4.9917|STANDARD_DEVIATION|18.0163||0.358|TWO_SIDED|95.0|-6.4553|16.4387|||t-test, 2 sided|df=11|t=0.960; p=0.358|||16.4387|-6.4553|0.358
72401728|NCT01520363|144310727|SUPERIORITY||Mean Difference (Net)|3.09412|STANDARD_DEVIATION|24.06228||0.603|TWO_SIDED|95.0|-9.27756|15.4658|||t-test, 2 sided|df=16|t=0.530; p=0.603|||15.46580|-9.27756|0.603
72401729|NCT01520363|144310727|SUPERIORITY||Mean Difference (Net)|2.42857|STANDARD_DEVIATION|11.21479||0.432|TWO_SIDED|95.0|-4.04665|8.9038|||t-test, 2 sided|df=13|t=0.810; p=0.432|||8.90380|-4.04665|0.432
72401730|NCT01520363|144310728|SUPERIORITY||Mean Difference (Net)|11.765|STANDARD_DEVIATION|26.276||0.083|TWO_SIDED|95.0|-1.745|25.275|||t-test, 2 sided|df=16|||t=1.846; p=0.083|25.275|-1.745|0.083
72401731|NCT01520363|144310728|SUPERIORITY||Mean Difference (Net)|7.5|STANDARD_DEVIATION|14.378||0.073|TWO_SIDED|95.0|-0.802|15.802|||t-test, 2 sided|df=13|||t=1.952; p=0.073|15.802|-0.802|0.073
72401732|NCT01520363|144310729|SUPERIORITY||Mean Difference (Net)|3.7474|STANDARD_DEVIATION|26.711||0.549|TWO_SIDED|95.0|-9.1269|16.6217|||t-test, 2 sided|df=18|t=0.612; p=0.549|||16.6217|-9.1269|0.549
72401733|NCT01520363|144310729|SUPERIORITY||Mean Difference (Net)|0.7143|STANDARD_DEVIATION|16.5084||0.874|TWO_SIDED|95.0|-8.8174|10.246|||t-test, 2 sided|df=13|t=0.162; p=0.874|||10.2460|-8.8174|0.874
72401734|NCT01520363|144310730|SUPERIORITY||Mean Difference (Net)|3.8167|STANDARD_DEVIATION|40.2609||0.693|TWO_SIDED|95.0|-16.2046|23.8379|||t-test, 2 sided|df=17|t=0.402; p=0.693|||23.8379|-16.2046|0.693
72401735|NCT01520363|144310730|SUPERIORITY||Mean Difference (Net)|0.84|STANDARD_DEVIATION|27.8994||0.909|TWO_SIDED|95.0|-14.6102|16.2902|||t-test, 2 sided|df=14|t=0.117; p=0.909|||16.2902|-14.6102|0.909
72481098|NCT03421431|144488545|SUPERIORITY||LS mean difference|-3.723||||0.4608|TWO_SIDED|95.0|-13.7|6.253|||ANCOVA|||||6.253|-13.700|0.4608
72481099|NCT03421431|144488545|SUPERIORITY||LS mean difference|-2.377||||0.6238|TWO_SIDED|95.0|-11.962|7.207|||ANCOVA|||||7.207|-11.962|0.6238
72481100|NCT03421431|144488545|SUPERIORITY||LS mean difference|-1.346||||0.7367|TWO_SIDED|95.0|-9.268|6.576|||ANCOVA|||||6.576|-9.268|0.7367
72481101|NCT03421431|144488546|SUPERIORITY||LS mean difference|-0.407||||0.8302|TWO_SIDED|95.0|-4.287|3.474|||ANCOVA|||||3.474|-4.287|0.8302
72481102|NCT03421431|144488546|SUPERIORITY||LS mean difference|-1.28||||0.5053|TWO_SIDED|95.0|-5.192|2.632|||ANCOVA|||||2.632|-5.192|0.5053
72481103|NCT03421431|144488546|SUPERIORITY||LS mean difference|0.873||||0.476|TWO_SIDED|95.0|-1.62|3.366|||ANCOVA|||||3.366|-1.620|0.4760
72481104|NCT03421431|144488547|SUPERIORITY||LS mean difference|-5.91||||0.0639|TWO_SIDED|95.0|-12.171|0.351|||ANCOVA|||||0.351|-12.171|0.0639
72401736|NCT01520363|144310731|SUPERIORITY||Mean Difference (Net)|-0.83|STANDARD_ERROR_OF_MEAN|0.64||0.21|TWO_SIDED|95.0|-2.17|0.52|||t-test, 2 sided|||||0.52|-2.17|0.21
72401737|NCT01520363|144310732|SUPERIORITY||Mean Difference (Net)|0.74|STANDARD_ERROR_OF_MEAN|0.68||0.28|TWO_SIDED|95.0|-0.66|2.15|||t-test, 2 sided|||||2.15|-0.66|0.28
72401738|NCT01272830|144310733|SUPERIORITY|||||||0.0063||||||Significance threshold p\<0.05|paired t-test|||Change from baseline data.||||0.0063
72481105|NCT03421431|144488547|SUPERIORITY||LS mean difference|-2.064||||0.4884|TWO_SIDED|95.0|-7.971|3.843|||ANCOVA|||||3.843|-7.971|0.4884
72481106|NCT03421431|144488547|SUPERIORITY||LS mean difference|-3.846||||0.1532|TWO_SIDED|95.0|-9.156|1.464|||ANCOVA|||||1.464|-9.156|0.1532
72481107|NCT03421431|144488548|SUPERIORITY||LS mean difference|-0.46||||0.0811|TWO_SIDED|95.0|-0.978|0.058|||ANCOVA|||||0.058|-0.978|0.0811
72623972|NCT00663260|144778404|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.11|STANDARD_ERROR_OF_MEAN|0.1457||0.435|TWO_SIDED|95.0|-0.4|0.17||Primary endpoints were tested at alpha=0.027 applying Dunnett's adjustment|ANCOVA|||||0.17|-0.40|0.435
72401739|NCT01272830|144310733|SUPERIORITY||||||>|0.05||||||Significant threshold p\<0.05|paired t-test|||Changes from baseline data||||>0.05
72481108|NCT03421431|144488548|SUPERIORITY||LS mean difference|0.117||||0.6312|TWO_SIDED|95.0|-0.367|0.601|||ANCOVA|||||0.601|-0.367|0.6312
72481109|NCT03421431|144488548|SUPERIORITY||LS mean difference|-0.577||||0.0099|TWO_SIDED|95.0|-1.011|-0.143|||ANCOVA|||||-0.143|-1.011|0.0099
72481110|NCT03421431|144488561|SUPERIORITY||LS mean difference|1.356||||0.112|TWO_SIDED|95.0|-0.322|3.034|||ANCOVA|||||3.034|-0.322|0.1120
72401740|NCT01272830|144310734|SUPERIORITY|||||||0.0226||||||Significance threshold p\<0.5|paired|||Change from baseline data (HSS pain walking)||||0.0226
72481111|NCT03421431|144488561|SUPERIORITY||LS mean difference|0.647||||0.4229|TWO_SIDED|95.0|-0.947|2.24|||ANCOVA|||||2.240|-0.947|0.4229
72481112|NCT03421431|144488561|SUPERIORITY||LS mean difference|0.71||||0.2764|TWO_SIDED|95.0|-0.577|1.996|||ANCOVA|||||1.996|-0.577|0.2764
72481113|NCT03421431|144488562|SUPERIORITY||LS mean difference|0.008||||0.5606|TWO_SIDED|95.0|-0.02|0.037|||ANCOVA|||||0.037|-0.020|0.5606
72481114|NCT03421431|144488562|SUPERIORITY||LS mean difference|0.023||||0.1002|TWO_SIDED|95.0|-0.004|0.05|||ANCOVA|||||0.050|-0.004|0.1002
72481115|NCT03421431|144488562|SUPERIORITY||LS mean difference|-0.014||||0.2002|TWO_SIDED|95.0|-0.036|0.008|||ANCOVA|||||0.008|-0.036|0.2002
72481116|NCT03421431|144488563|SUPERIORITY||LS mean difference|-178.787||||0.7014|TWO_SIDED|95.0|-1098.454|740.88|||ANCOVA|||||740.880|-1098.454|0.7014
72481117|NCT03421431|144488563|SUPERIORITY||LS mean difference|52.307||||0.907|TWO_SIDED|95.0|-830.934|935.547|||ANCOVA|||||935.547|-830.934|0.9070
72481118|NCT03421431|144488563|SUPERIORITY||LS mean difference|-231.094||||0.536|TWO_SIDED|95.0|-967.273|505.086|||ANCOVA|||||505.086|-967.273|0.5360
72481119|NCT03421431|144488564|SUPERIORITY||LS mean difference|-753.153||||0.2985|TWO_SIDED|95.0|-2183.92|677.614|||ANCOVA|||||677.614|-2183.920|0.2985
72481120|NCT03421431|144488564|SUPERIORITY||LS mean difference|139.107||||0.8413|TWO_SIDED|95.0|-1236.689|1514.902|||ANCOVA|||||1514.902|-1236.689|0.8413
72481121|NCT03421431|144488564|SUPERIORITY||LS mean difference|-892.26||||0.1168|TWO_SIDED|95.0|-2011.705|227.186|||ANCOVA|||||227.186|-2011.705|0.1168
72481122|NCT03421431|144488565|SUPERIORITY||LS mean difference|33.491|||<|0.0001|TWO_SIDED|95.0|17.984|48.998|||ANCOVA|||||48.998|17.984|<0.0001
72481123|NCT03421431|144488565|SUPERIORITY||LS mean difference|30.814|||<|0.0001|TWO_SIDED|95.0|15.802|45.825|||ANCOVA|||||45.825|15.802|<0.0001
72401741|NCT01272830|144310734|SUPERIORITY|||||||0.0375||||||Significance threshold P\<0.05|paired t-test|||Change from baseline data (HSS total score)||||0.0375
72401742|NCT01272830|144310734|SUPERIORITY|||||||0.0391||||||Significance threshold p\<0.05|paired t-test|||Change from baseline data (KSS knee pain)||||0.0391
72401743|NCT01272830|144310734|SUPERIORITY|||||||0.2137|||||||paired t-test|||Changes from baseline data (HSS pain walking)||||0.2137
72401744|NCT01272830|144310734|SUPERIORITY|||||||0.1312|||||||paired t-test|||Change from baseline data (HSS total score)||||0.1312
72401745|NCT01272830|144310734|SUPERIORITY|||||||0.1578|||||||paired t-test|||Change from baseline data (KSS knee pain)||||0.1578
72481124|NCT03421431|144488565|SUPERIORITY||LS mean difference|2.677||||0.6757|TWO_SIDED|95.0|-9.946|15.3|||ANCOVA|||||15.300|-9.946|0.6757
72481125|NCT03421431|144488566|SUPERIORITY||LS mean difference|21.3||||0.0134|TWO_SIDED|95.0|4.533|38.067|||ANCOVA|||||38.067|4.533|0.0134
72481126|NCT03421431|144488566|SUPERIORITY||LS mean difference|5.847||||0.4686|TWO_SIDED|95.0|-10.116|21.811|||ANCOVA|||||21.811|-10.116|0.4686
72481127|NCT03421431|144488566|SUPERIORITY||LS mean difference|15.453||||0.0181|TWO_SIDED|95.0|2.699|28.206|||ANCOVA|||||28.206|2.699|0.0181
72481128|NCT03421431|144488567|SUPERIORITY||LS mean difference|4.324||||0.0557|TWO_SIDED|95.0|-0.108|8.756|||ANCOVA|||||8.756|-0.108|0.0557
72481129|NCT03421431|144488567|SUPERIORITY||LS mean difference|2.305||||0.2867|TWO_SIDED|95.0|-1.955|6.566|||ANCOVA|||||6.566|-1.955|0.2867
72481130|NCT03421431|144488567|SUPERIORITY||LS mean difference|2.019||||0.2437|TWO_SIDED|95.0|-1.39|5.429|||ANCOVA|||||5.429|-1.390|0.2437
72481131|NCT03421431|144488568|SUPERIORITY||LS mean difference|0.019||||0.9913|TWO_SIDED|95.0|-3.491|3.53|||ANCOVA|||||3.530|-3.491|0.9913
72481132|NCT03421431|144488568|SUPERIORITY||LS mean difference|0.995||||0.553|TWO_SIDED|95.0|-2.323|4.314|||ANCOVA|||||4.314|-2.323|0.5530
72510137|NCT01953328|144550884|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-66.87|STANDARD_ERROR_OF_MEAN|3.03|<|0.001|TWO_SIDED|95.0|-72.88|-60.87||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|The null hypothesis was that there was no difference in the percent change from baseline at Week 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.||-60.87|-72.88|<0.001
72510138|NCT01953328|144550885|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-89.3|STANDARD_ERROR_OF_MEAN|4.6|<|0.001|TWO_SIDED|95.0|-98.4|-80.2||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-80.2|-98.4|<0.001
72401746|NCT01272830|144310735|SUPERIORITY|||||||0.0083||||||Significance threshold p\<0.05|t-test|||Changes from baseline data||||0.0083
72510139|NCT01953328|144550885|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-86.3|STANDARD_ERROR_OF_MEAN|4.4|<|0.001|TWO_SIDED|95.0|-95.1|-77.5||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-77.5|-95.1|<0.001
72510140|NCT01953328|144550885|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-68.7|STANDARD_ERROR_OF_MEAN|3.3|<|0.001|TWO_SIDED|95.0|-75.3|-62.1||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-62.1|-75.3|<0.001
72510141|NCT01953328|144550885|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-72.0|STANDARD_ERROR_OF_MEAN|3.7|<|0.001|TWO_SIDED|95.0|-79.5|-64.6||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-64.6|-79.5|<0.001
72566798|NCT02312713|144664436|NON_INFERIORITY|Since there were not sufficient data in prior literature to specific an a priori non-inferiority margin, for this and other secondary outcomes we based conclusions and discussions on magnitude of differences between the group, descriptively. This strategy was specified in the protocol.|Mean Difference (Final Values)|-0.5||||0|TWO_SIDED|95.0|-0.84|-0.16|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Internet Based Exercise Training at 4 months.||-0.16|-0.84|0.00
72401747|NCT01272830|144310735|SUPERIORITY||||||>|0.05||||||Significant threshold p\<0.05|paired t-test|||Change from baseline data||||>0.05
72401748|NCT01272830|144310736|SUPERIORITY|||||||0.01||||||Significance threshold p\<0.05|ANOVA|||Change from baseline data||||0.01
72510142|NCT01953328|144550886|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-90.8|STANDARD_ERROR_OF_MEAN|5.1|<|0.001|TWO_SIDED|95.0|-100.9|-80.7||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-80.7|-100.9|<0.001
72510143|NCT01953328|144550886|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-83.6|STANDARD_ERROR_OF_MEAN|4.5|<|0.001|TWO_SIDED|95.0|-92.5|-74.8||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-74.8|-92.5|<0.001
72510144|NCT01953328|144550886|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-69.6|STANDARD_ERROR_OF_MEAN|3.5|<|0.001|TWO_SIDED|95.0|-76.5|-62.6||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-62.6|-76.5|<0.001
72481133|NCT03421431|144488568|SUPERIORITY||LS mean difference|-0.976||||0.4729|TWO_SIDED|95.0|-3.665|1.713|||ANCOVA|||||1.713|-3.665|0.4729
72401749|NCT01272830|144310736|SUPERIORITY||||||>|0.05|||||||paired t-test|Significant threshold p\<0.05||Changes from baseline data||||>0.05
72401750|NCT00579826|144310753|SUPERIORITY_OR_OTHER_LEGACY|||||||0.92|||||||Wilcoxon (Mann-Whitney)|||||||0.92
72401751|NCT00579826|144310754|SUPERIORITY_OR_OTHER_LEGACY|||||||0.96|||||||Wilcoxon (Mann-Whitney)|||||||0.96
72401752|NCT00579826|144310755|SUPERIORITY_OR_OTHER_LEGACY|||||||0.73|||||||Wilcoxon (Mann-Whitney)|||||||0.73
72401753|NCT00579826|144310756|SUPERIORITY|||||||0.64|||||||Wilcoxon (Mann-Whitney)|||||||0.64
72401754|NCT00579826|144310757|SUPERIORITY|||||||0.73|||||||Wilcoxon (Mann-Whitney)|||||||0.73
72401755|NCT04191382|144310758|OTHER|Other descriptive analysis|Ratio of Geometric Means|1.08|||||TWO_SIDED|95.0|0.72|1.63||||||Geometric LS-means ratio of proportional change was the ratio of geometric LS-means of the proportional change between groups (Amcenestrant 400 mg versus Letrozole 2.5 mg).||1.63|0.72|
72481134|NCT04147650|144488572|SUPERIORITY||Odds Ratio (OR)|2.18||||0.1352|TWO_SIDED|95.0|0.62|7.62|||Regression, Logistic|||0.05 % VOS versus vehicle||7.62|0.62|0.1352
72481135|NCT04147650|144488572|SUPERIORITY||Odds Ratio (OR)|1.78||||0.2823|TWO_SIDED|95.0|0.49|6.45|||Regression, Logistic|||0.10% VOS versus vehicle||6.45|0.49|0.2823
72481136|NCT04147650|144488572|SUPERIORITY||Odds Ratio (OR)|2.41||||0.0889|TWO_SIDED|95.0|0.7|8.3|||Regression, Logistic|||0.20% VOS versus vehicle||8.30|0.70|0.0889
72510145|NCT01953328|144550886|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-65.5|STANDARD_ERROR_OF_MEAN|4.2|<|0.001|TWO_SIDED|95.0|-73.8|-57.1||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-57.1|-73.8|<0.001
72481137|NCT04147650|144488573|SUPERIORITY||Least square mean difference|-2.6||||0.3604|TWO_SIDED|95.0|-9.6|4.3|||ANCOVA|||0.05% VOS versus vehicle||4.3|-9.6|0.3604
72481138|NCT04147650|144488573|SUPERIORITY||Least square mean difference|-2.6||||0.3737|TWO_SIDED|95.0|-9.6|4.4|||ANCOVA|||0.10% VOS versus vehicle||4.4|-9.6|0.3737
72481139|NCT04147650|144488573|SUPERIORITY||Least square mean difference|1.8||||0.5307|TWO_SIDED|95.0|-5.1|8.6|||ANCOVA|||0.20% VOS versus vehicle||8.6|-5.1|0.5307
72481140|NCT01128738|144488575|SUPERIORITY_OR_OTHER||Percentage difference|50.2|||<|0.001|TWO_SIDED|95.0|38.1|62.3|||Fisher Exact||Percentage difference was estimated as BTX 50 U minus placebo.|||62.3|38.1|<0.001
72481141|NCT01178671|144488623|SUPERIORITY_OR_OTHER|||||||0.17|TWO_SIDED||||||Mixed Models Analysis|||||||0.17
72481142|NCT01178671|144488624|SUPERIORITY_OR_OTHER|||||||0.82|TWO_SIDED||||||t-test, 2 sided|||||||0.82
72481143|NCT01178671|144488625|SUPERIORITY_OR_OTHER|||||||0.14|TWO_SIDED||||||t-test, 2 sided|||||||.14
72481144|NCT01178671|144488626|SUPERIORITY_OR_OTHER|||||||0.5|TWO_SIDED||||||t-test, 2 sided|||||||.50
72401756|NCT04191382|144310758|OTHER|Other descriptive analysis|Ratio of Geometric Means|1.42|||||TWO_SIDED|95.0|0.95|2.12||||||Geometric LS-means ratio of proportional change was the ratio of geometric LS-means of the proportional change between groups (Amcenestrant 200 mg versus Letrozole 2.5 mg).||2.12|0.95|
72481145|NCT01178671|144488627|SUPERIORITY_OR_OTHER|||||||0.023|TWO_SIDED||||||Mixed Models Analysis|||||||0.023
72481146|NCT01178671|144488628|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.8||||0.31|TWO_SIDED||||||Mixed Models Analysis|||||||0.31
72481147|NCT01178671|144488629|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.7||||0.042|TWO_SIDED|95.0|1.1|19.9|||Mixed Models Analysis|||||19.9|1.1|0.042
72481148|NCT01178671|144488630|SUPERIORITY_OR_OTHER|||||||0.14|TWO_SIDED||||||Chi-squared|||||||0.14
72481149|NCT01178671|144488631|SUPERIORITY_OR_OTHER|||||||0.21|TWO_SIDED||||||Mixed Models Analysis|||||||0.21
72481150|NCT01178671|144488632|SUPERIORITY_OR_OTHER|||||||0.65|TWO_SIDED||||||Mixed Models Analysis|||||||0.65
72481151|NCT01211197|144488636|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability.|Geometric mean ratio|100.59|STANDARD_DEVIATION|7.6|||TWO_SIDED|90.0|95.75|105.67|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment|Standard deviation is actually the intra-individual geometric coefficient of variation (gCV).|Ratio calculated as FDC fasted divided by individual tablets fasted.||105.67|95.75|
72510146|NCT01953328|144550887|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-68.67|STANDARD_ERROR_OF_MEAN|2.21|<|0.001|TWO_SIDED|95.0|-73.06|-64.27||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-64.27|-73.06|<0.001
72481152|NCT01211197|144488636|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability.|Geometric mean ratio|94.94|STANDARD_DEVIATION|8.0|||TWO_SIDED|90.0|89.85|100.33|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment|Standard deviation is actually the intra-individual gCV.|Ratio calculated as FDC fed divided by FDC fasted||100.33|89.85|
72481153|NCT01211197|144488637|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability.|Geometric mean ratio|99.31|STANDARD_DEVIATION|12.2|||TWO_SIDED|90.0|91.76|107.49|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment|Standard deviation is actually the intra-individual gCV.|Ratio calculated as FDC fasted divided by individual tablets fasted||107.49|91.76|
72481154|NCT01211197|144488637|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability.|Geometric mean ratio|64.3|STANDARD_DEVIATION|20.6|||TWO_SIDED|90.0|55.97|73.87|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment|Standard deviation is actually the intra-individual gCV.|Ratio calculated as FDC fed divided by FDC fasted||73.87|55.97|
72481155|NCT01211197|144488638|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability.|Geometric mean ratio|100.94|STANDARD_DEVIATION|7.7|||TWO_SIDED|90.0|96.03|106.11|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment|Standard deviation is actually the intra-individual gCV.|Ratio calculated as FDC fasted divided by individual tablets fasted||106.11|96.03|
72481156|NCT01211197|144488638|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability.|Geometric mean ratio|94.39|STANDARD_DEVIATION|8.2|||TWO_SIDED|90.0|89.22|99.87|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment|Standard deviation is actually the intra-individual gCV.|Ratio calculated as FDC fed divided by FDC fasted||99.87|89.22|
72481157|NCT01211197|144488639|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability.|Geometric mean ratio|103.13|STANDARD_DEVIATION|11.7|||TWO_SIDED|90.0|95.59|111.25|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment|Standard deviation is actually the intra-individual gCV.|Ratio calculated as FDC fasted divided by individual tablets fasted||111.25|95.59|
72481158|NCT01211197|144488639|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability.|Geometric mean ratio|96.96|STANDARD_DEVIATION|15.5|||TWO_SIDED|90.0|87.23|107.78|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment|Standard deviation is actually the intra-individual gCV.|Ratio calculated as FDC fed divided by FDC fasted||107.78|87.23|
72481159|NCT01211197|144488640|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability.|Geometric mean ratio|102.15|STANDARD_DEVIATION|13.0|||TWO_SIDED|90.0|93.87|111.15|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment|Standard deviation is actually the intra-individual gCV.|Ratio calculated as FDC fasted divided by individual tablets fasted||111.15|93.87|
72481160|NCT01211197|144488640|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability.|Geometric mean ratio|100.67|STANDARD_DEVIATION|13.7|||TWO_SIDED|90.0|91.7|110.51|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment|Standard deviation is actually the intra-individual gCV.|Ratio calculated as FDC fed divided by FDC fasted||110.51|91.70|
72510147|NCT01953328|144550887|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-65.95|STANDARD_ERROR_OF_MEAN|1.91|<|0.001|TWO_SIDED|95.0|-69.74|-62.16||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-62.16|-69.74|<0.001
72510148|NCT01953328|144550887|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-68.14|STANDARD_ERROR_OF_MEAN|2.6|<|0.001|TWO_SIDED|95.0|-73.3|-62.99||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-62.99|-73.30|<0.001
72510149|NCT01953328|144550887|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-67.28|STANDARD_ERROR_OF_MEAN|1.94|<|0.001|TWO_SIDED|95.0|-71.14|-63.42||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-63.42|-71.14|<0.001
72510150|NCT01953328|144550888|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-68.93|STANDARD_ERROR_OF_MEAN|2.54|<|0.001|TWO_SIDED|95.0|-73.96|-63.89||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-63.89|-73.96|<0.001
72510151|NCT01953328|144550888|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-63.58|STANDARD_ERROR_OF_MEAN|2.2|<|0.001|TWO_SIDED|95.0|-67.96|-59.21||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-59.21|-67.96|<0.001
72510152|NCT01953328|144550888|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-68.82|STANDARD_ERROR_OF_MEAN|3.01|<|0.001|TWO_SIDED|95.0|-74.79|-62.86||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-62.86|-74.79|<0.001
72510153|NCT01953328|144550888|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-60.89|STANDARD_ERROR_OF_MEAN|2.47|<|0.001|TWO_SIDED|95.0|-65.78|-55.99||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-55.99|-65.78|<0.001
72510154|NCT01953328|144550889|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-64.44|STANDARD_ERROR_OF_MEAN|2.04|<|0.001|TWO_SIDED|95.0|-68.49|-60.39||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-60.39|-68.49|<0.001
72510155|NCT01953328|144550889|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-59.24|STANDARD_ERROR_OF_MEAN|2.05|<|0.001|TWO_SIDED|95.0|-63.3|-55.17||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-55.17|-63.30|<0.001
72510156|NCT01953328|144550889|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-60.06|STANDARD_ERROR_OF_MEAN|2.42|<|0.001|TWO_SIDED|95.0|-64.87|-55.25||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-55.25|-64.87|<0.001
72510157|NCT01953328|144550889|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-63.39|STANDARD_ERROR_OF_MEAN|1.9|<|0.001|TWO_SIDED|95.0|-67.15|-59.62||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-59.62|-67.15|<0.001
72510158|NCT01953328|144550890|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-65.56|STANDARD_ERROR_OF_MEAN|2.4|<|0.001|TWO_SIDED|95.0|-70.34|-60.79||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-60.79|-70.34|<0.001
72510159|NCT01953328|144550890|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-57.23|STANDARD_ERROR_OF_MEAN|2.43|<|0.001|TWO_SIDED|95.0|-62.05|-52.4||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-52.40|-62.05|<0.001
72510160|NCT01953328|144550890|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-60.37|STANDARD_ERROR_OF_MEAN|2.79|<|0.001|TWO_SIDED|95.0|-65.91|-54.83||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-54.83|-65.91|<0.001
72510161|NCT01953328|144550890|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-56.15|STANDARD_ERROR_OF_MEAN|2.4|<|0.001|TWO_SIDED|95.0|-60.92|-51.39||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-51.39|-60.92|<0.001
72510162|NCT01953328|144550891|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-45.54|STANDARD_ERROR_OF_MEAN|1.92|<|0.001|TWO_SIDED|95.0|-49.35|-41.73||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-41.73|-49.35|<0.001
72623973|NCT00663260|144778405|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.6|STANDARD_ERROR_OF_MEAN|8.142|||TWO_SIDED|95.0|-29.7|2.4||Secondary endpoints were tested following a sequential testing procedure at alpha=0.05; secondary efficacy analyses were not tested since the primary endpoint was not significant.|ANCOVA|||||2.4|-29.7|
72481161|NCT01211197|144488641|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability.|Geometric mean ratio|103.49|STANDARD_DEVIATION|12.7|||TWO_SIDED|90.0|95.3|112.39|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment|Standard deviation is actually the intra-individual gCV.|Ratio calculated as FDC fasted divided by individual tablets fasted||112.39|95.30|
72481162|NCT01211197|144488641|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability.|Geometric mean ratio|75.13|STANDARD_DEVIATION|24.5|||TWO_SIDED|90.0|63.68|88.64|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment|Standard deviation is actually the intra-individual gCV.|Ratio calculated as FDC fed divided by FDC fasted||88.64|63.68|
72481163|NCT02683941|144488675|SUPERIORITY||Hazard Ratio (HR)|0.94||||0.866|TWO_SIDED|95.0|0.48|1.95|||Log Rank|||The hazard ratio and the 95% confidence interval (CI) were estimated using a Cox proportional hazards model, stratified for interactive web response system (IWRS) tumour subtype (typical versus \[vs\] atypical) using the exact method for ties. P-value of stratified log rank test comparing lanreotide to placebo with strata based on the IWRS tumour subtype (typical vs atypical) stratification factor.||1.95|0.48|0.866
72481164|NCT02683941|144488676|SUPERIORITY||Hazard Ratio (HR)|0.93||||0.837|TWO_SIDED|95.0|0.48|1.88|||Log Rank|||The hazard ratio and the 95% CI were estimated using a Cox proportional hazards model, stratified for IWRS tumour subtype (typical vs atypical) using the exact method for ties. P-value of stratified log rank test comparing lanreotide to placebo with strata based on the IWRS tumour subtype (typical vs atypical) stratification factor.||1.88|0.48|0.837
72481165|NCT02683941|144488677|OTHER||Percentage difference|14.0|||||TWO_SIDED|95.0|-10.97|37.86||||||The treatment difference compares lanreotide to placebo (central review). The 95% exact unconditional CI was used for ORR difference.||37.86|-10.97|
72481166|NCT02683941|144488677|OTHER||Percentage difference|2.0|||||TWO_SIDED|95.0|-22.69|26.53||||||The treatment difference compares lanreotide to placebo (local review). The 95% exact unconditional CI was used for ORR difference.||26.53|-22.69|
72481167|NCT02683941|144488678|SUPERIORITY||Hazard Ratio (HR)|0.86||||0.582|TWO_SIDED|95.0|0.5|1.5|||Log Rank|||The hazard ratio and the 95% CI were estimated using a Cox proportional hazards model, stratified for IWRS tumour subtype (typical vs atypical) using the exact method for ties. P-value of stratified log rank test comparing lanreotide to placebo with strata based on the IWRS tumour subtype (typical vs atypical) stratification factor.||1.50|0.50|0.582
72481168|NCT00892723|144488729|SUPERIORITY_OR_OTHER|||||||0.87||95.0|||||Wilcoxon (rank sum)|For this early phase study, no adjustment was used.||||||0.87
72401757|NCT00729183|144310767|SUPERIORITY_OR_OTHER||Difference in LS Means|3.49|||<|0.001|TWO_SIDED|95.0|2.66|4.32|||Longitudinal Data Analysis (LDA) Model|||A longitudinal ANCOVA was used to obtain an estimate of the between-treatment difference in aBMD together with its 95% confidence interval (CI). The model, applied on all time points during treatment (Screening Visit \[BL\], Month 6, Month 12, Month 24), included treatment, region, time and interaction between treatment and time as fixed effects, and BL value as covariate. The weighted Least Squares (LS) mean is based on the described model. Difference in LS Means = Odancatib 50 mg minus Placebo.||4.32|2.66|<0.001
72401758|NCT00729183|144310768|SUPERIORITY_OR_OTHER||Difference in Percentage|-2.2|||||TWO_SIDED|95.0|-12.3|7.9||||||Estimated difference (versus Placebo) and CI were based on the Miettinen \& Nurminen method.||7.9|-12.3|
72481169|NCT00892723|144488729|SUPERIORITY_OR_OTHER|||||||0.86||95.0|||||Wilcoxon (rank sum)|For this early phase study, no adjustment was used.||||||0.86
72481170|NCT00892723|144488729|SUPERIORITY_OR_OTHER|||||||0.11||95.0|||||Wilcoxon (rank sum)|For this early phase study, no adjustment was used.||||||0.11
72481171|NCT00892723|144488729|SUPERIORITY_OR_OTHER|||||||0.91||95.0|||||Wilcoxon (rank sum)|For this early phase study, no adjustment was used.||||||0.91
72481172|NCT00892723|144488730|SUPERIORITY_OR_OTHER|||||||0.23||95.0|||||Wilcoxon (rank sum)|For this early phase study, no adjustment was used.||||||0.23
72481173|NCT00892723|144488730|SUPERIORITY_OR_OTHER|||||||0.82||95.0|||||Wilcoxon (rank sum)|For this early phase study, no adjustment was used.||||||0.82
72481174|NCT00892723|144488730|SUPERIORITY_OR_OTHER|||||||0.23||95.0|||||Wilcoxon (rank sum)|For this early phase study, no adjustment was used.||||||0.23
72481175|NCT00892723|144488730|SUPERIORITY_OR_OTHER|||||||0.71||95.0|||||Wilcoxon (rank sum)|For this early phase study, no adjustment was used.||||||0.71
72481176|NCT00892723|144488731|SUPERIORITY_OR_OTHER|||||||0.73||95.0|||||Wilcoxon (rank sum)|For this early phase study, no adjustment was used.||||||0.73
72481177|NCT00892723|144488731|SUPERIORITY_OR_OTHER|||||||0.94||95.0|||||Wilcoxon (rank sum)|For this early phase study, no adjustment was used.||||||0.94
72481178|NCT00892723|144488731|SUPERIORITY_OR_OTHER|||||||0.14||95.0|||||Wilcoxon (rank sum)|For this early phase study, no adjustment was used.||||||0.14
72481179|NCT00892723|144488731|SUPERIORITY_OR_OTHER|||||||0.68||95.0|||||Wilcoxon (rank sum)|For this early phase study, no adjustment was used.||||||0.68
72481180|NCT00892723|144488731|SUPERIORITY_OR_OTHER|||||||0.56||95.0|||||Wilcoxon (rank sum)|For this early phase study, no adjustment was used.||||||0.56
72481181|NCT00892723|144488731|SUPERIORITY_OR_OTHER|||||||0.32||95.0|||||Wilcoxon (rank sum)|For this early phase study, no adjustment was used.||||||0.32
72481182|NCT00892723|144488731|SUPERIORITY_OR_OTHER|||||||0.33||95.0|||||Wilcoxon (rank sum)|For this early phase study, no adjustment was used.||||||0.33
72481183|NCT00892723|144488731|SUPERIORITY_OR_OTHER|||||||0.65||95.0|||||Wilcoxon (rank sum)|For this early phase study, no adjustment was used.||||||0.65
72481184|NCT00892723|144488731|SUPERIORITY_OR_OTHER|||||||0.21||95.0|||||Wilcoxon (rank sum)|For this early phase study, no adjustment was used.||||||0.21
72481185|NCT00892723|144488731|SUPERIORITY_OR_OTHER|||||||0.9||95.0|||||Wilcoxon (rank sum)|For this early phase study, no adjustment was used.||||||0.90
72481186|NCT00892723|144488732|SUPERIORITY_OR_OTHER|||||||0.16|TWO_SIDED|95.0|||||Wilcoxon (signed rank)|For this early phase study, no adjustment was used.||||||0.16
72623974|NCT00663260|144778405|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.0|STANDARD_ERROR_OF_MEAN|8.136|||TWO_SIDED|95.0|-25.0|7.0||Secondary endpoints were tested following a sequential testing procedure at alpha=0.05; secondary efficacy analyses were not tested since the primary endpoint was not significant.|ANCOVA|||||7.0|-25.0|
72401759|NCT00729183|144310769|SUPERIORITY_OR_OTHER||Difference in Percentage|4.4|||||TWO_SIDED|95.0|-3.2|12.3||||||Estimated difference (versus Placebo) and CI were based on the Miettinen \& Nurminen method.||12.3|-3.2|
72401760|NCT00729183|144310770|SUPERIORITY_OR_OTHER||Difference in LS Means|5.39|||<|0.001|TWO_SIDED|95.0|4.36|6.42|||LDA|||A longitudinal ANCOVA model was used to obtain an estimate of the between-treatment difference in aBMD together with its 95% CI. The model, applied on all time points during treatment (Screening Visit \[Baseline\], Month 6, Month 12, Month 24), included treatment, region, time and interaction between treatment and time as fixed effects, and BL value as covariate. The weighted LS mean is based on the described model. Difference in LS Means = Odancatib 50 mg minus Placebo.||6.42|4.36|<0.001
72401761|NCT00729183|144310771|SUPERIORITY_OR_OTHER||Difference in LS Means|1.57|||<|0.001|TWO_SIDED|95.0|0.88|2.25|||LDA|||MONTH 12: A longitudinal ANCOVA model was used to obtain an estimate of the between-treatment difference in aBMD together with its 95% CI. The model, applied on all time points during treatment (Screening Visit \[Baseline\], Month 6, Month 12, Month 24), included treatment, region, time and interaction between treatment and time as fixed effects, and baseline value as covariate. The weighted LS mean is based on the described model. Difference in LS Means at Month 12 = Odancatib 50 mg minus Placebo||2.25|0.88|<0.001
72401762|NCT00729183|144310771|SUPERIORITY_OR_OTHER||Difference in LS Means|3.32|||<|0.001|TWO_SIDED|95.0|2.39|4.26|||LDA|||MONTH 24: A longitudinal ANCOVA model was used to obtain an estimate of the between-treatment difference in aBMD together with its 95% CI. The model, applied on all time points during treatment (Screening Visit \[Baseline\], Month 6, Month 12, Month 24), included treatment, region, time and interaction between treatment and time as fixed effects, and baseline value as covariate. The weighted LS mean is based on the described model. Difference in LS Means at Month 24 = Odancatib 50 mg minus Placebo||4.26|2.39|<0.001
72401763|NCT00729183|144310772|SUPERIORITY_OR_OTHER||Difference in LS Means|1.48||||0.001|TWO_SIDED|95.0|0.6|2.35|||LDA|||MONTH 12: A longitudinal ANCOVA model was used to obtain an estimate of the between-treatment difference in aBMD together with its 95% CI. The model, applied on all time points during treatment (Screening Visit \[Baseline\], Month 6, Month 12, Month 24), included treatment, region, time and interaction between treatment and time as fixed effects, and baseline value as covariate. The weighted LS mean is based on the described model. Difference in LS Means at Month 12 = Odancatib 50 mg minus Placebo||2.35|0.60|0.001
72401764|NCT00729183|144310772|SUPERIORITY_OR_OTHER||Difference in LS Means|3.81|||<|0.001|TWO_SIDED|95.0|2.69|4.93|||LDA|||MONTH 24: A longitudinal ANCOVA model was used to obtain an estimate of the between-treatment difference in aBMD together with its 95% CI. The model, applied on all time points during treatment (Screening Visit \[Baseline\], Month 6, Month 12, Month 24), included treatment, region, time and interaction between treatment and time as fixed effects, and baseline value as covariate. The weighted LS mean is based on the described model. Difference in LS Means at Month 24 = Odancatib 50 mg minus Placebo||4.93|2.69|<0.001
72401765|NCT00729183|144310773|SUPERIORITY_OR_OTHER||Difference in LS Means|2.19|||<|0.001|TWO_SIDED|95.0|1.09|3.29|||LDA|||MONTH 12: A longitudinal ANCOVA model was used to obtain an estimate of the between-treatment difference in aBMD together with its 95% CI. The model, applied on all time points during treatment (Screening Visit \[Baseline\], Month 6, Month 12, Month 24), included treatment, region, time and interaction between treatment and time as fixed effects, and baseline value as covariate. The weighted LS mean is based on the described model. Difference in LS Means at Month 12 = Odancatib 50 mg minus Placebo||3.29|1.09|<0.001
72481187|NCT00892723|144488732|SUPERIORITY_OR_OTHER|||||||0.74|TWO_SIDED|95.0||||For this early phase study, no adjustment was used.|Wilcoxon (signed rank)|||||||0.74
72401766|NCT00729183|144310773|SUPERIORITY_OR_OTHER||Difference in LS Means|5.48|||<|0.001|TWO_SIDED|95.0|4.08|6.89|||LDA|||MONTH 24: A longitudinal ANCOVA model was used to obtain an estimate of the between-treatment difference in aBMD together with its 95% CI. The model, applied on all time points during treatment (Screening Visit \[Baseline\], Month 6, Month 12, Month 24), included treatment, region, time and interaction between treatment and time as fixed effects, and baseline value as covariate. The weighted LS mean is based on the described model. Difference in LS Means at Month 24 = Odancatib 50 mg minus Placebo||6.89|4.08|<0.001
72401767|NCT00729183|144310774|SUPERIORITY_OR_OTHER||Difference in LS Means|0.71||||0.03|TWO_SIDED|95.0|0.07|1.35|||LDA|||MONTH 12: A longitudinal ANCOVA model was used to obtain an estimate of the between-treatment difference in aBMD together with its 95% CI. The model, applied on all time points during treatment (Screening Visit \[Baseline\], Month 6, Month 12, Month 24), included treatment, region, time and interaction between treatment and time as fixed effects, and baseline value as covariate. The weighted LS mean is based on the described model. Difference in LS Means at Month 12 = Odancatib 50 mg minus Placebo||1.35|0.07|0.030
72401768|NCT00729183|144310774|SUPERIORITY_OR_OTHER||Difference in LS Means|1.7|||<|0.001|TWO_SIDED|95.0|0.97|2.43|||LDA|||MONTH 24: A longitudinal ANCOVA model was used to obtain an estimate of the between-treatment difference in aBMD together with its 95% CI. The model, applied on all time points during treatment (Screening Visit \[Baseline\], Month 6, Month 12, Month 24), included treatment, region, time and interaction between treatment and time as fixed effects, and baseline value as covariate. The weighted LS mean is based on the described model. Difference in LS Means at Month 24 = Odancatib 50 mg minus Placebo||2.43|0.97|<0.001
72481188|NCT00892723|144488732|SUPERIORITY_OR_OTHER|||||||0.45|TWO_SIDED|95.0||||For this early phase study, no adjustments were used.|Wilcoxon (signed rank)|||||||0.45
72481189|NCT00892723|144488732|SUPERIORITY_OR_OTHER|||||||0.079|TWO_SIDED|95.0|||||Wilcoxon (signed rank)|For this early phase study, no adjustments were used.||||||0.079
72481190|NCT00892723|144488732|SUPERIORITY_OR_OTHER|||||||0.16|TWO_SIDED|95.0|||||Wilcoxon (signed rank)|For this early phase study, no adjustments were used.||||||0.16
72481191|NCT00892723|144488732|SUPERIORITY_OR_OTHER|||||||0.45|TWO_SIDED|95.0||||For this early phase study, no adjustments were used.|Wilcoxon (signed rank)|For this early phase study, no adjustments were used.||||||0.45
72481192|NCT00150969|144488733|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05||95.0|||||t-test, 2 sided|||||||<0.05
72481193|NCT00150969|144488740|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05||95.0|||||t-test, 2 sided|||||||<0.05
72401769|NCT00729183|144310775|SUPERIORITY_OR_OTHER||Difference in LS Means|1.71||||0.001|TWO_SIDED|95.0|0.69|2.73|||LDA|||MONTH 12: A longitudinal ANCOVA model was used to obtain an estimate of the between-treatment difference in aBMD together with its 95% CI. The model, applied on all time points during treatment (Screening Visit \[Baseline\], Month 6, Month 12, Month 24), included treatment, region, time and interaction between treatment and time as fixed effects, and baseline value as covariate. The weighted LS mean is based on the described model. Difference in LS Means at Month 12 = Odancatib 50 mg minus Placebo||2.73|0.69|0.001
72401770|NCT00729183|144310775|SUPERIORITY_OR_OTHER||Difference in LS Means|2.7|||<|0.001|TWO_SIDED|95.0|1.62|3.78|||LDA|||MONTH 24: A longitudinal ANCOVA model was used to obtain an estimate of the between-treatment difference in aBMD together with its 95% CI. The model, applied on all time points during treatment (Screening Visit \[Baseline\], Month 6, Month 12, Month 24), included treatment, region, time and interaction between treatment and time as fixed effects, and baseline value as covariate. The weighted LS mean is based on the described model. Difference in LS Means at Month 24 = Odancatib 50 mg minus Placebo||3.78|1.62|<0.001
72481194|NCT01313689|144488760|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.79||||0.2677|TWO_SIDED|95.0|0.5|1.24|||Log Rank|P-value is based on the stratified log-rank test adjusted for 'interval' and pooled stratum|Hazard ratios are estimated using the Pike estimator, adjusted for 'interval' and pooled stratum|||1.24|0.50|0.2677
72481195|NCT01313689|144488760|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.54||||0.0837|TWO_SIDED|95.0|0.19|1.53|||Log Rank|P-value is based on the stratified log-rank test adjusted for 'interval' and pooled stratum|Hazard ratios are estimated using the Pike estimator, adjusted for 'interval' and pooled stratum|||1.53|0.19|0.0837
72481196|NCT01313689|144488761|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.56||||0.003|TWO_SIDED|95.0|0.35|0.87|||Log Rank|P-value is based on the stratified log-rank test adjusted for 'interval' and pooled stratum|Hazard ratios are estimated using the Pike estimator, adjusted for 'interval' and pooled stratum.|||0.87|0.35|0.0030
72510163|NCT01953328|144550891|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-43.43|STANDARD_ERROR_OF_MEAN|1.69|<|0.001|TWO_SIDED|95.0|-46.78|-40.08||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-40.08|-46.78|<0.001
72623975|NCT00663260|144778406|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.81|STANDARD_ERROR_OF_MEAN|0.4435|||TWO_SIDED|95.0|-2.68|-0.94||Secondary endpoints were tested following a sequential testing procedure at alpha=0.05; secondary efficacy analyses were not tested since the primary endpoint was not significant.|ANCOVA|||||-0.94|-2.68|
72623976|NCT00663260|144778406|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.16|STANDARD_ERROR_OF_MEAN|0.4395|||TWO_SIDED|95.0|-3.03|-1.29||Secondary endpoints were tested following a sequential testing procedure at alpha=0.05; secondary efficacy analyses were not tested since the primary endpoint was not significant.|ANCOVA|||||-1.29|-3.03|
72623977|NCT02231580|144778414|SUPERIORITY_OR_OTHER||GLS mean ratio|1.104|||=|0.5743|TWO_SIDED|90.0|0.823|1.482|||MMRM|||Left hand position-index statistical analysis is presented (BN82451B versus Placebo). The Mixed Effect Model Repeat Measurement (MMRM) analysis was performed on log-transformed data using the restricted maximum likelihood (REML) model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||1.482|0.823|=0.5743
72623978|NCT02231580|144778414|SUPERIORITY_OR_OTHER||GLS mean ratio|1.141|||=|0.4349|TWO_SIDED|90.0|0.862|1.51|||MMRM|||Right hand position-index statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||1.510|0.862|=0.4349
72481197|NCT01313689|144488761|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.49||||0.0262|TWO_SIDED|95.0|0.21|1.17|||Log Rank|P-value is based on the stratified log-rank test adjusted for 'interval' and pooled stratum|Hazard ratios are estimated using the Pike estimator, adjusted for 'interval' and pooled stratum|||1.17|0.21|0.0262
72481198|NCT01313689|144488762|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.942||||0.0223|TWO_SIDED|95.0|1.166|7.424|||Regression, Logistic|conditional logistic regression with interval and pooled stratum||||7.424|1.166|0.0223
72481199|NCT01313689|144488762|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|999.999||||0.9985|TWO_SIDED|95.0|0.001|999.999|||Regression, Logistic|conditional logistic regression with interval and pooled stratum||||999.999|0.001|0.9985
72481200|NCT01313689|144488763|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.366||||0.4159|TWO_SIDED|95.0|0.644|2.899||Odds ratios and p-value are based on conditional logistic regression with interval and pooled stratum included in the Strata statement|Regression, Logistic|||||2.899|0.644|0.4159
72481201|NCT01313689|144488763|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.225||||0.8866|TWO_SIDED|95.0|0.076|19.862||Odds ratios and p-value are based on conditional logistic regression with interval and pooled stratum in the strata statement|Regression, Logistic|||||19.862|0.076|0.8866
72510164|NCT01953328|144550891|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-40.98|STANDARD_ERROR_OF_MEAN|1.96|<|0.001|TWO_SIDED|95.0|-44.88|-37.08||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-37.08|-44.88|<0.001
72623979|NCT02231580|144778415|SUPERIORITY_OR_OTHER||GLS mean ratio|1.035|||=|0.8937|TWO_SIDED|90.0|0.675|1.587|||MMRM|||Left hand orientation-index statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||1.587|0.675|=0.8937
72623980|NCT02231580|144778415|SUPERIORITY_OR_OTHER||GLS mean ratio|1.093|||=|0.636|TWO_SIDED|90.0|0.8|1.493|||MMRM|||Right hand orientation-index statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||1.493|0.800|=0.6360
72401771|NCT00729183|144310776|SUPERIORITY_OR_OTHER||Difference in LS Means|0.16||||0.697|TWO_SIDED|95.0|-0.63|0.95|||LDA|||MONTH 12: A longitudinal ANCOVA model was used to obtain an estimate of the between-treatment difference in aBMD together with its 95% CI. The model, applied on all time points during treatment (Screening Visit \[Baseline\], Month 6, Month 12, Month 24), included treatment, region, time and interaction between treatment and time as fixed effects, and baseline value as covariate. The weighted LS mean is based on the described model. Difference in LS Means at Month 12 = Odancatib 50 mg minus Placebo||0.95|-0.63|0.697
72401772|NCT00729183|144310776|SUPERIORITY_OR_OTHER||Difference in LS Means|1.22||||0.013|TWO_SIDED|95.0|0.27|2.18|||LDA|||MONTH 24: A longitudinal ANCOVA model was used to obtain an estimate of the between-treatment difference in aBMD together with its 95% CI. The model, applied on all time points during treatment (Screening Visit \[Baseline\], Month 6, Month 12, Month 24), included treatment, region, time and interaction between treatment and time as fixed effects, and baseline value as covariate. The weighted LS mean is based on the described model. Difference in LS Means at Month 24 = Odancatib 50 mg minus Placebo||2.18|0.27|0.013
72401773|NCT00729183|144310777|SUPERIORITY_OR_OTHER||Difference in LS Means|8.01|||<|0.001|TWO_SIDED|95.0|6.03|9.99|||LDA|||MONTH 12: A longitudinal ANCOVA model was used to obtain an estimate of the between-treatment difference in aBMD together with its 95% CI. The model, applied on all time points during treatment (Screening Visit \[Baseline\], Month 6, Month 12, Month 24), included treatment, region, time and interaction between treatment and time as fixed effects, and baseline value as covariate. The weighted LS mean is based on the described model. Difference in LS Means at Month 12 = Odancatib 50 mg minus Placebo||9.99|6.03|<0.001
72401774|NCT00729183|144310777|SUPERIORITY_OR_OTHER||Difference in LS Means|11.46|||<|0.001|TWO_SIDED|95.0|8.96|13.97|||LDA|||MONTH 24: A longitudinal ANCOVA model was used to obtain an estimate of the between-treatment difference in aBMD together with its 95% CI. The model, applied on all time points during treatment (Screening Visit \[Baseline\], Month 6, Month 12, Month 24), included treatment, region, time and interaction between treatment and time as fixed effects, and baseline value as covariate. The weighted LS mean is based on the described model. Difference in LS Means at Month 24 = Odancatib 50 mg minus Placebo||13.97|8.96|<0.001
72401775|NCT00729183|144310778|SUPERIORITY_OR_OTHER||Difference in LS Means|5.68|||<|0.001|TWO_SIDED|95.0|3.77|7.58|||LDA|||MONTH 12: A longitudinal ANCOVA model was used to obtain an estimate of the between-treatment difference in aBMD together with its 95% CI. The model, applied on all time points during treatment (Screening Visit \[Baseline\], Month 6, Month 12, Month 24), included treatment, region, time and interaction between treatment and time as fixed effects, and baseline value as covariate. The weighted LS mean is based on the described model. Difference in LS Means at Month 12 = Odancatib 50 mg minus Placebo||7.58|3.77|<0.001
72481202|NCT01313689|144488764|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.75||||0.1732|TWO_SIDED|95.0|0.48|1.17|||Log Rank|P-value is based on the stratified log-rank test adjusted for 'interval' and pooled stratum|Hazard ratios are estimated using the Pike estimator, adjusted for 'interval' and pooled stratum|||1.17|0.48|0.1732
72481203|NCT01313689|144488764|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.11||||0.8128|TWO_SIDED|95.0|0.46|2.68||P-value is based on the stratified log-rank test adjusted for 'interval' and pooled stratum|Log Rank||Hazard ratios are estimated using the Pike estimator, adjusted for 'interval' and pooled stratum|||2.68|0.46|0.8128
72481204|NCT01519466|144488817|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.71|STANDARD_DEVIATION|2.32||0.0926|TWO_SIDED|95.0|-1.55|0.12|||t-test, 2 sided|||||0.12|-1.55|0.0926
72481205|NCT01519466|144488817|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.17|STANDARD_DEVIATION|2.97||||||||||||||||
72481206|NCT01519466|144488818|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.09|STANDARD_DEVIATION|0.49||0.3251|TWO_SIDED|95.0|-0.27|0.09|||t-test, 2 sided|||||0.09|-0.27|0.3251
72481207|NCT01519466|144488818|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.09|STANDARD_DEVIATION|0.51||||||||||||||||
72481208|NCT01519466|144488819|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.13|STANDARD_DEVIATION|1.26||0.5798|TWO_SIDED|95.0|-0.33|0.58|||t-test, 2 sided|||Hyperglycaemia, glucose above 10mmol/l (180mg/dL)||0.58|-0.33|0.5798
72481209|NCT01519466|144488819|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.31|STANDARD_DEVIATION|1.03||0.096|TWO_SIDED|95.0|-0.68|0.06|||t-test, 2 sided|||Hypoglycaemia, glucose below 3.9mmol/l (70mg/dL)||0.06|-0.68|0.0960
72481210|NCT01519466|144488819|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.36|STANDARD_DEVIATION|6.53||0.0007|TWO_SIDED|95.0|2.01|6.71|||t-test, 2 sided|||Treatment Satisfaction||6.71|2.01|0.0007
72481211|NCT00147823|144488821|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||ANOVA|Using baseline (6 wk) and two year post operative predicted effects data, and setting desirable power to detect our effects to 80%||The sample size provided at least 80% power at a 5% alpha level to detect a medium to large effect in patients receiving Vitoss alone compared to combination therapy consisting of Vitoss with Bone Marrow Aspirate. Since a random coefficients model was used to analyze the data, the sample size calculation was estimated under this model assuming a 3% attrition rate between all measurement times.||||<0.01
72481212|NCT00147823|144488822|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||Chi-squared, Corrected|||||||<0.01
72481213|NCT00561951|144488849|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.34||||0.002||95.0|-0.56|-0.13||The closed testing procedure was used in order to control the probability of a type 1 error.|ANCOVA|Analysis of covariance model with the treatment group, region as fixed effects and baseline values as a covariate was used.||The significance level was 0.05 (2-sided).||-0.13|-0.56|0.002
72481214|NCT00561951|144488849|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.39|||<|0.001||95.0|-0.6|-0.17||The closed testing procedure was used in order to control the probability of a type 1 error.|ANCOVA|Analysis of covariance model with the treatment group, region as fixed effects and baseline values as a covariate was used.||The significance level was 0.05 (2-sided).||-0.17|-0.60|<0.001
72481215|NCT00561951|144488851|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.56||||0.002||95.0|-0.91|-0.22|||ANCOVA|Analysis of covariance model with the treatment group, region as fixed effects and baseline values as a covariate was used.||The significance level was 0.05 (2-sided).||-0.22|-0.91|0.002
72401776|NCT00729183|144310778|SUPERIORITY_OR_OTHER||Difference in LS Means|9.38|||<|0.001|TWO_SIDED|95.0|6.98|11.77|||LDA|||MONTH 24: A longitudinal ANCOVA model was used to obtain an estimate of the between-treatment difference in aBMD together with its 95% CI. The model, applied on all time points during treatment (Screening Visit \[Baseline\], Month 6, Month 12, Month 24), included treatment, region, time and interaction between treatment and time as fixed effects, and baseline value as covariate. The weighted LS mean is based on the described model. Difference in LS Means at Month 24 = Odancatib 50 mg minus Placebo||11.77|6.98|<0.001
72481216|NCT00561951|144488851|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.66|||<|0.001||95.0|-1.01|-0.32|||ANCOVA|Analysis of covariance model with the treatment group, region as fixed effects and baseline values as a covariate was used.||The significance level was 0.05 (2-sided).||-0.32|-1.01|<0.001
72481217|NCT00561951|144488853|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.65||||0.003||95.0|-1.07|-0.22|||ANCOVA|Analysis of covariance model with the treatment group, region as fixed effects and baseline values as a covariate was used.||The significance level was 0.05 (2-sided).||-0.22|-1.07|0.003
72481218|NCT00561951|144488853|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.66||||0.002||95.0|-1.09|-0.23|||ANCOVA|Analysis of covariance model with the treatment group, region as fixed effects and baseline values as a covariate was used.||The significance level was 0.05 (2-sided).||-0.23|-1.09|0.002
72481219|NCT00561951|144488855|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.39||||0.002||95.0|-0.63|-0.14|||ANCOVA|Analysis of covariance model with the treatment group, region as fixed effects and baseline values as a covariate was used.||The significance level was 0.05 (2-sided).||-0.14|-0.63|0.002
72481220|NCT00561951|144488855|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.27||||0.03||95.0|-0.52|-0.03|||ANCOVA|Analysis of covariance model with the treatment group, region as fixed effects and baseline values as a covariate was used.||The significance level was 0.05 (2-sided).||-0.03|-0.52|0.030
72510165|NCT01953328|144550891|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-43.14|STANDARD_ERROR_OF_MEAN|1.68|<|0.001|TWO_SIDED|95.0|-46.48|-39.8||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-39.80|-46.48|<0.001
72510166|NCT01953328|144550892|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-45.44|STANDARD_ERROR_OF_MEAN|2.21|<|0.001|TWO_SIDED|95.0|-49.83|-41.05||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-41.05|-49.83|<0.001
72510167|NCT01953328|144550892|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-41.34|STANDARD_ERROR_OF_MEAN|1.76|<|0.001|TWO_SIDED|95.0|-44.84|-37.85||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-37.85|-44.84|<0.001
72401777|NCT00729183|144310779|SUPERIORITY_OR_OTHER||Difference in LS Means|-54.03|||<|0.001|TWO_SIDED|95.0|-64.81|-43.26|||LDA|||MONTH 12: A longitudinal ANCOVA model was used to obtain geometric LS mean percent change from BL in s-CTx (back-transformation of the log-transformed fraction from BL) and its 95% CI. The model, applied on all time points during treatment (Baseline \[Randomization\], Month 6, Month 12, Month 18, Month 24), included treatment, region, time and interaction between treatment and time as fixed effects, and baseline value as covariate. Difference in LS Means at Month 12 = Odancatib 50 mg minus Placebo||-43.26|-64.81|<0.001
72481221|NCT00561951|144488857|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.04||||0.624||95.0|-0.18|0.11|||ANCOVA|Analysis of covariance model with the treatment group, region as fixed effects and baseline values as a covariate was used.||The significance level was 0.05 (2-sided).||0.11|-0.18|0.624
72481222|NCT00561951|144488857|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.11||||0.129||95.0|-0.26|0.03|||ANCOVA|Analysis of covariance model with the treatment group, region as fixed effects and baseline values as a covariate was used.||The significance level was 0.05 (2-sided).||0.03|-0.26|0.129
72481223|NCT04508023|144488894|SUPERIORITY||Cox Proportional Hazard|1.16||||0.626|TWO_SIDED|95.0|0.63|2.15|||Log Rank|Log rank test stratified by the time from COVID-19 positive test to randomization.||||2.15|0.63|0.626
72510168|NCT01953328|144550892|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-40.96|STANDARD_ERROR_OF_MEAN|2.21|<|0.001|TWO_SIDED|95.0|-45.35|-36.57||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-36.57|-45.35|<0.001
72510169|NCT01953328|144550892|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-38.44|STANDARD_ERROR_OF_MEAN|1.93|<|0.001|TWO_SIDED|95.0|-42.26|-34.62||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-34.62|-42.26|<0.001
72481224|NCT03261700|144488903|SUPERIORITY||||||<|0.05|||||||Mixed Models Analysis|||Comparison of groups on Empowerment via the Personal Progress Scale Revised||||<.05
72481225|NCT03261700|144488904|SUPERIORITY||||||<|0.05|||||||Mixed Models Analysis|||Comparison of groups on self-efficacy via the General Self-Efficacy Scale||||<.05
72481226|NCT01340196|144488919|SUPERIORITY_OR_OTHER||Geometric mean ratio|121.89|STANDARD_DEVIATION|14.1|||TWO_SIDED|90.0|111.714|132.999|||ANOVA|No formal testing. Investigation of relative bioavailability.|The standard deviation is actually the intra-individual geometric coefficient of variation (gCV).|||132.999|111.714|
72481227|NCT01340196|144488920|SUPERIORITY_OR_OTHER||Geometric mean ratio|94.72|STANDARD_DEVIATION|17.2|||TWO_SIDED|90.0|85.215|105.29|||ANOVA|No formal testing. Investigation of relative bioavailability.|The standard deviation is actually the intra-individual gCV.|||105.290|85.215|
72481228|NCT01340196|144488921|SUPERIORITY_OR_OTHER||Geometric mean ratio|147.12|STANDARD_DEVIATION|14.6||||90.0|134.482|160.943|||ANOVA|No formal testing. Investigation of relative bioavailability.|The standard deviation is actually the intra-individual gCV.|||160.943|134.482|
72481229|NCT01340196|144488922|SUPERIORITY_OR_OTHER||Geometric mean ratio|77.88|STANDARD_DEVIATION|13.4|||TWO_SIDED|90.0|71.24|85.15|||ANOVA|No formal testing. Investigation of relative bioavailability.|The standard deviation is actually the intra-individual gCV.|||85.15|71.24|
72401778|NCT00729183|144310779|SUPERIORITY_OR_OTHER||Difference in LS Means|-45.59|||<|0.001|TWO_SIDED|95.0|-62.22|-28.96|||LDA|||MONTH 24: A longitudinal ANCOVA model was used to obtain geometric LS mean percent change from BL in s-CTx (back-transformation of the log-transformed fraction from BL) and its 95% CI. The model, applied on all time points during treatment (Baseline \[Randomization\], Month 6, Month 12, Month 18, Month 24), included treatment, region, time and interaction between treatment and time as fixed effects, and baseline value as covariate. Difference in LS Means at Month 12 = Odancatib 50 mg minus Placebo||-28.96|-62.22|<0.001
72481230|NCT01340196|144488923|SUPERIORITY_OR_OTHER||Geometric mean ratio|81.73|STANDARD_DEVIATION|20.1|||TWO_SIDED|90.0|71.56|93.34|||ANOVA|No formal testing. Investigation of relative bioavailability.|The standard deviation is actually the intra-individual gCV.|||93.34|71.56|
72481231|NCT01340196|144488924|SUPERIORITY_OR_OTHER||Geometric mean ratio|75.27|STANDARD_DEVIATION|13.7|||TWO_SIDED|90.0|68.71|82.45|||ANOVA|No formal testing. Investigation of relative bioavailability.|The standard deviation is actually the intra-individual gCV.|||82.45|68.71|
72481232|NCT00081770|144488962|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.95||||0.567||95.0|0.79|1.14||Holm's method for multiplicity adjustment was to be used to control the overall Type I error rate at α = 0.05. However, since there was no significant difference in the overall SVR rates between the three groups, no Type-1 error adjustment was made.|Regression, Logistic|The p-value is based on the logistic regression model that includes treatment and baseline stratification factors (viral load and race).|The odds ratio is based on the logistic regression model that includes treatment and baseline stratification factors: viral load (≤600,000 IU/mL vs \>600,000 IU/mL) and race (Black vs non-Black).|||1.14|0.79|0.567
72481233|NCT00081770|144488962|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.08||||0.195||95.0|0.9|1.3||Holm's method for multiplicity adjustment was to be used to control the overall Type I error rate at α = 0.05. However, since there was no significant difference in the overall SVR rates between the three groups, no Type-1 error adjustment was made.|Regression, Logistic|The p-value is based on the logistic regression model that includes treatment and baseline stratification factors (viral load and race).|The odds ratio is based on the logistic regression model that includes treatment and baseline stratification factors: viral load (≤600,000 IU/mL vs \>600,000 IU/mL) and race (Black vs non-Black).|||1.30|0.90|0.195
72481234|NCT00081770|144488964|SUPERIORITY_OR_OTHER||Percentage of participants|39.9||||||95.0|36.9|42.9|||||Percentage of participants with undetectable HCV-RNA at Treatment Week 12|||42.9|36.9|
72481235|NCT00081770|144488964|SUPERIORITY_OR_OTHER||Percentage of participants|36.0||||||95.0|33.1|39.0|||||Percentage of participants with undetectable HCV-RNA at Treatment Week 12|||39.0|33.1|
72481236|NCT00081770|144488964|SUPERIORITY_OR_OTHER||Percentage of participants|45.0||||||95.0|42.0|48.1|||||Percentage of participants with undetectable HCV-RNA at Treatment Week 12|||48.1|42.0|
72481237|NCT00601419|144488968|SUPERIORITY_OR_OTHER||||||=|0.556|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Age. The null hypothesis is that there is no difference between \<65 years and \>=65 years in the frequency of treatment related adverse events."||||=0.556
72481238|NCT00601419|144488969|SUPERIORITY_OR_OTHER||||||=|0.845|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Gender. The null hypothesis is that there is no difference between Male and Female in the frequency of treatment related adverse events."||||=0.845
72481239|NCT00601419|144488970|SUPERIORITY_OR_OTHER||||||=|0.038|TWO_SIDED||||||Fisher Exact|||"The null hypothesis is that there is no difference between With TSH deficiency and Without TSH deficiency in the frequency of treatment related adverse events."||||=0.038
72481240|NCT00601419|144488971|SUPERIORITY_OR_OTHER||||||=|0.013|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Past history. The null hypothesis is that there is no difference between With past history and Without past history in the frequency of treatment related adverse events."||||=0.013
72481241|NCT00601419|144488972|SUPERIORITY_OR_OTHER||||||=|0.037|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Initial Dose. The null hypothesis is that there is no association between Initial Dose and the frequency of treatment related adverse events."||||=0.037
72481242|NCT00601419|144488972|SUPERIORITY_OR_OTHER||||||=|0.063|TWO_SIDED||||||Cochran-Armitage Exact|||"The risk factor tested was Initial Dose. The null hypothesis is that there is no linear trend in the frequency of treatment related adverse events across increasing levels of initial dose."||||=0.063
72481243|NCT00601419|144488974|SUPERIORITY_OR_OTHER||||||=|0.019|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Age. The null hypothesis is that there is no difference between \<65 years of age and \>=65 years of age in the efficacy of somatropin."||||=0.019
72481244|NCT00601419|144488975|SUPERIORITY_OR_OTHER||||||=|1|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Gender. The null hypothesis is that there is no difference between male and female in the efficacy of somatropin."||||=1.000
72481245|NCT00601419|144488976|SUPERIORITY_OR_OTHER||||||=|0.037|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was ACTH deficiency. The null hypothesis is that there is no difference between With ACTH deficiency and Without ACTH deficiency in the efficacy of somatropin."||||=0.037
72481246|NCT02349451|144489070|SUPERIORITY||response rate difference|39.8|||<|0.001|TWO_SIDED|95.0|17.2|57.7||P-value is calculated by one-sided Fisher's exact test to test whether ABT-122 treatment group is superior to placebo group. The a priori statistical significance threshold is P = 0.025.|Fisher Exact|||||57.7|17.2|<0.001
72481247|NCT02349451|144489070|SUPERIORITY||response rate difference|50.3|||<|0.001|TWO_SIDED|95.0|28.1|67.4||P-value is calculated by one-sided Fisher's exact test to test whether ABT-122 treatment group is superior to placebo group. The a priori statistical significance threshold is P = 0.025.|Fisher Exact|||||67.4|28.1|<0.001
72481248|NCT02349451|144489071|SUPERIORITY||response rate difference|-3.3||||0.723|TWO_SIDED|95.0|-18.5|12.1||P-value is calculated by one-sided Fisher's exact test to test whether ABT-122 treatment group is superior to adalimumab group.|Fisher Exact|||||12.1|-18.5|0.723
72481249|NCT02349451|144489071|SUPERIORITY||response rate difference|7.3||||0.215|TWO_SIDED|95.0|-7.4|21.6||P-value is calculated by one-sided Fisher's exact test to test whether ABT-122 treatment group is superior to adalimumab group.|Fisher Exact|||||21.6|-7.4|0.215
72481250|NCT02349451|144489072|SUPERIORITY||response rate difference|24.1||||0.021|TWO_SIDED|95.0|3.9|39.3||P-value is calculated by one-sided Fisher's exact test to test whether ABT-122 treatment group is superior to placebo group.|Fisher Exact|||||39.3|3.9|0.021
72481251|NCT02349451|144489072|SUPERIORITY||response rate difference|-0.9||||0.611|TWO_SIDED|95.0|-16.5|14.8||P-value is calculated by one-sided Fisher's exact test to test whether ABT-122 treatment group is superior to adalimumab group.|Fisher Exact|||||14.8|-16.5|0.611
72481252|NCT02349451|144489072|SUPERIORITY||response rate difference|40.9|||<|0.001|TWO_SIDED|95.0|20.1|55.8||P-value is calculated by one-sided Fisher's exact test to test whether ABT-122 treatment group is superior to placebo group.|Fisher Exact|||||55.8|20.1|<0.001
72481253|NCT02349451|144489072|SUPERIORITY||response rate difference|15.9||||0.039|TWO_SIDED|95.0|-0.3|31.3||P-value is calculated by one-sided Fisher's exact test to test whether ABT-122 treatment group is superior to adalimumab group.|Fisher Exact|||||31.3|-0.3|0.039
72481254|NCT02349451|144489073|SUPERIORITY||response rate difference|18.4||||0.034|TWO_SIDED|95.0|1.5|29.7||P-value is calculated by one-sided Fisher's exact test to test whether ABT-122 treatment group is superior to placebo group.|Fisher Exact|||||29.7|1.5|0.034
72481255|NCT02349451|144489073|SUPERIORITY||response rate difference|7.3||||0.185|TWO_SIDED|95.0|-5.8|19.9||P-value is calculated by one-sided Fisher's exact test to test whether ABT-122 treatment group is superior to adalimumab group.|Fisher Exact|||||19.9|-5.8|0.185
72481256|NCT02349451|144489073|SUPERIORITY||response rate difference|27.3||||0.004|TWO_SIDED|95.0|9.6|39.0||P-value is calculated by one-sided Fisher's exact test to test whether ABT-122 treatment group is superior to placebo group.|Fisher Exact|||||39.0|9.6|0.004
72481257|NCT02349451|144489073|SUPERIORITY||response rate difference|16.2||||0.017|TWO_SIDED|95.0|2.3|29.3||P-value is calculated by one-sided Fisher's exact test to test whether ABT-122 treatment group is superior to adalimumab group.|Fisher Exact|||||29.3|2.3|0.017
72510170|NCT01953328|144550893|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-54.77|STANDARD_ERROR_OF_MEAN|2.32|<|0.001|TWO_SIDED|95.0|-59.37|-50.17||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-50.17|-59.37|<0.001
72510171|NCT01953328|144550893|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-52.66|STANDARD_ERROR_OF_MEAN|2.17|<|0.001|TWO_SIDED|95.0|-56.95|-48.36||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-48.36|-56.95|<0.001
72481258|NCT02349451|144489074|SUPERIORITY||||||<|0.001||||||Kolmogorov-Smirnov test based on the empirical distribution function is applied to get the p-value of comparing the ABT-122 treatment group with placebo group.|Kolmogorov-Smirnov test|||||||<0.001
72481259|NCT02349451|144489074|SUPERIORITY|||||||0.561||||||Kolmogorov-Smirnov test based on the empirical distribution function is applied to get the p-value of comparing the ABT-122 treatment group with adalimumab group.|Kolmogorov-Smirnov test|||||||0.561
72481260|NCT02349451|144489074|SUPERIORITY||||||<|0.001||||||Kolmogorov-Smirnov test based on the empirical distribution function is applied to get the p-value of comparing the ABT-122 treatment group with placebo group.|Kolmogorov-Smirnov test|||||||<0.001
72481261|NCT02349451|144489074|SUPERIORITY|||||||0.106||||||Kolmogorov-Smirnov test based on the empirical distribution function is applied to get the p-value of comparing the ABT-122 treatment group with adalimumab group.|Kolmogorov-Smirnov test|||||||0.106
72510172|NCT01953328|144550893|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-50.83|STANDARD_ERROR_OF_MEAN|1.96|<|0.001|TWO_SIDED|95.0|-54.72|-46.93||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-46.93|-54.72|<0.001
72481262|NCT02349451|144489075|SUPERIORITY||Least squares mean difference|-1.07|||<|0.001|TWO_SIDED|95.0|-1.58|-0.57||Two-sided p-value is calculated from ANCOVA model with treatment group as the fixed factor and baseline value as the covariate.|ANCOVA|||||-0.57|-1.58|<0.001
72481263|NCT02349451|144489075|SUPERIORITY||Least squares mean difference|-0.13||||0.479|TWO_SIDED|95.0|-0.48|0.23||Two-sided p-value is calculated from ANCOVA model with treatment group as the fixed factor and baseline value as the covariate.|ANCOVA|||||0.23|-0.48|0.479
72481264|NCT02349451|144489075|SUPERIORITY||Least squares mean difference|-1.4|||<|0.001|TWO_SIDED|95.0|-1.9|-0.89||Two-sided p-value is calculated from ANCOVA model with treatment group as the fixed factor and baseline value as the covariate.|ANCOVA|||||-0.89|-1.90|<0.001
72481265|NCT02349451|144489075|SUPERIORITY||Least squares mean difference|-0.45||||0.012|TWO_SIDED|95.0|-0.81|-0.1||Two-sided p-value is calculated from ANCOVA model with treatment group as the fixed factor and baseline value as the covariate.|ANCOVA|||||-0.10|-0.81|0.012
72481266|NCT02349451|144489076|SUPERIORITY||Least squares mean difference|-1.17|||<|0.001|TWO_SIDED|95.0|-1.81|-0.53||Two-sided p-value is calculated from ANCOVA model with treatment group as the fixed factor and baseline value as the covariate.|ANCOVA|||||-0.53|-1.81|<0.001
72481267|NCT02349451|144489076|SUPERIORITY||Least squares mean difference|-0.09||||0.696|TWO_SIDED|95.0|-0.54|0.36||Two-sided p-value is calculated from ANCOVA model with treatment group as the fixed factor and baseline value as the covariate.|ANCOVA|||||0.36|-0.54|0.696
72481268|NCT02349451|144489076|SUPERIORITY||Least squares mean difference|-1.41|||<|0.001|TWO_SIDED|95.0|-2.04|-0.77||Two-sided p-value is calculated from ANCOVA model with treatment group as the fixed factor and baseline value as the covariate.|ANCOVA|||||-0.77|-2.04|<0.001
72401779|NCT00729183|144310780|SUPERIORITY_OR_OTHER||Difference in LS Means|-25.34|||<|0.001|TWO_SIDED|95.0|-37.77|-12.92|||LDA|||MONTH 12: A longitudinal ANCOVA model was used to obtain geometric LS mean percent change from BL in s-P1NP (back-transformation of the log-transformed fraction from BL) and its 95% CI. The model, applied on all time points during treatment (Baseline \[Randomization\], Month 6, Month 12, Month 18, Month 24), included treatment, region, time and interaction between treatment and time as fixed effects, and BL value as covariate. Difference in LS Means at Month 12 = Odancatib 50 mg minus Placebo.||-12.92|-37.77|<0.001
72481269|NCT02349451|144489076|SUPERIORITY||Least squares mean difference|-0.33||||0.151|TWO_SIDED|95.0|-0.77|0.12||Two-sided p-value is calculated from ANCOVA model with treatment group as the fixed factor and baseline value as the covariate.|ANCOVA|||||0.12|-0.77|0.151
72510173|NCT01953328|144550893|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-49.69|STANDARD_ERROR_OF_MEAN|2.04|<|0.001|TWO_SIDED|95.0|-53.74|-45.64||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-45.64|-53.74|<0.001
72401780|NCT00729183|144310780|SUPERIORITY_OR_OTHER||Difference in LS Means|-9.07||||0.225|TWO_SIDED|95.0|-23.69|5.56|||LDA|||MONTH 24: A longitudinal ANCOVA model was used to obtain geometric LS mean percent change from BL in s-P1NP (back-transformation of the log-transformed fraction from BL) and its 95% CI. The model, applied on all time points during treatment (Baseline \[Randomization\], Month 6, Month 12, Month 18, Month 24), included treatment, region, time and interaction between treatment and time as fixed effects, and BL value as covariate. Difference in LS Means at Month 24 = Odancatib 50 mg minus Placebo.||5.56|-23.69|0.225
72481270|NCT02349451|144489077|SUPERIORITY||Least squares mean difference|-3.17|||<|0.001|TWO_SIDED|95.0|-4.14|-2.19||Two-sided p-value is calculated from ANCOVA model with treatment group as the fixed factor and baseline value as the covariate.|ANCOVA|||||-2.19|-4.14|<0.001
72481271|NCT02349451|144489077|SUPERIORITY||Least squares mean difference|-0.81||||0.021|TWO_SIDED|95.0|-1.51|-0.12||Two-sided p-value is calculated from ANCOVA model with treatment group as the fixed factor and baseline value as the covariate.|ANCOVA|||||-0.12|-1.51|0.021
72481272|NCT02349451|144489077|SUPERIORITY||Least squares mean difference|-2.73|||<|0.001|TWO_SIDED|95.0|-3.7|-1.75||Two-sided p-value is calculated from ANCOVA model with treatment group as the fixed factor and baseline value as the covariate.|ANCOVA|||||-1.75|-3.70|<0.001
72481273|NCT02349451|144489077|SUPERIORITY||Least squares mean difference|-0.37||||0.288|TWO_SIDED|95.0|-1.06|0.32||Two-sided p-value is calculated from ANCOVA model with treatment group as the fixed factor and baseline value as the covariate.|ANCOVA|||||0.32|-1.06|0.288
72510174|NCT01953328|144550894|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-55.45|STANDARD_ERROR_OF_MEAN|2.76|<|0.001|TWO_SIDED|95.0|-60.93|-49.98||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-49.98|-60.93|<0.001
72510175|NCT01953328|144550894|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-50.95|STANDARD_ERROR_OF_MEAN|2.5|<|0.001|TWO_SIDED|95.0|-55.91|-46.0||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-46.00|-55.91|<0.001
72510176|NCT01953328|144550894|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-51.36|STANDARD_ERROR_OF_MEAN|2.3|<|0.001|TWO_SIDED|95.0|-55.93|-46.8||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-46.80|-55.93|<0.001
72510177|NCT01953328|144550894|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-45.44|STANDARD_ERROR_OF_MEAN|2.33|<|0.001|TWO_SIDED|95.0|-50.08|-40.81||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-40.81|-50.08|<0.001
72566799|NCT02312713|144664436|NON_INFERIORITY|Since there were not sufficient data in prior literature to specific an a priori non-inferiority margin, for this and other secondary outcomes we based conclusions and discussions on magnitude of differences between the group, descriptively. This strategy was specified in the protocol.|Mean Difference (Final Values)|0.04||||0.83|TWO_SIDED|95.0|-0.31|0.39|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Internet-Based Exercise Training at 12 months.||0.39|-0.31|0.83
72401781|NCT03878446|144310783|SUPERIORITY||Treatment difference|-1.4|||||TWO_SIDED|95.0|-3.2|0.4||||||||0.4|-3.2|
72401782|NCT03878446|144310783|SUPERIORITY||Treatment difference|0.7|||||TWO_SIDED|95.0|-1.1|2.5||||||||2.5|-1.1|
72566800|NCT02312713|144664437|SUPERIORITY||Mean Difference (Final Values)|7.75||||0.04|TWO_SIDED|95.0|0.43|15.07|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Wait List Control at 4 months for the 2 Minute Step Test.||15.07|0.43|0.04
72401783|NCT03878446|144310783|SUPERIORITY||Treatment difference|-0.9|||||TWO_SIDED|95.0|-2.6|0.9||||||||0.9|-2.6|
72401784|NCT03878446|144310783|SUPERIORITY||Treatment difference|-0.6|||||TWO_SIDED|95.0|-2.4|1.2||||||||1.2|-2.4|
72481274|NCT02168842|144489096|EQUIVALENCE|Comparison of the risk of need for antiparkinsonian therapy in Isradipine group to the risk in placebo group.|Hazard Ratio (HR)|0.79||||0.073|TWO_SIDED|95.0|0.61|1.03|||Log Rank|||||1.03|0.61|0.073
72481275|NCT02168842|144489097|EQUIVALENCE|Comparison the risk of need for dyskinesia in Isradipine group to the risk in a placebo group.|Hazard Ratio (HR)|1.53||||0.21|TWO_SIDED|95.0|0.78|3.01|||Log Rank|||||3.01|0.78|0.21
72481276|NCT02168842|144489098|EQUIVALENCE|Comparison of the risk of need for antiparkinsonian therapy in Isradipine group to the risk in placebo group.|Hazard Ratio (HR)|0.83||||0.35|TWO_SIDED|95.0|0.56|1.22|||Log Rank|||||1.22|0.56|0.35
72510178|NCT01953328|144550895|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-66.47|STANDARD_ERROR_OF_MEAN|2.07|<|0.001|TWO_SIDED|95.0|-70.58|-62.36||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-62.36|-70.58|<0.001
72510179|NCT01953328|144550895|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-64.33|STANDARD_ERROR_OF_MEAN|2.35|<|0.001|TWO_SIDED|95.0|-69.01|-59.66||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-59.66|-69.01|<0.001
72510180|NCT01953328|144550895|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-64.05|STANDARD_ERROR_OF_MEAN|2.44|<|0.001|TWO_SIDED|95.0|-68.9|-59.2||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-59.20|-68.90|<0.001
72510181|NCT01953328|144550895|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-67.26|STANDARD_ERROR_OF_MEAN|2.07|<|0.001|TWO_SIDED|95.0|-71.36|-63.15||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-63.15|-71.36|<0.001
72510182|NCT01953328|144550896|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-68.29|STANDARD_ERROR_OF_MEAN|2.24|<|0.001|TWO_SIDED|95.0|-72.75|-63.84||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-63.84|-72.75|<0.001
72510183|NCT01953328|144550896|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-62.53|STANDARD_ERROR_OF_MEAN|2.81|<|0.001|TWO_SIDED|95.0|-68.11|-56.94||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-56.94|-68.11|<0.001
72510184|NCT01953328|144550896|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-63.97|STANDARD_ERROR_OF_MEAN|2.75|<|0.001|TWO_SIDED|95.0|-69.44|-58.5||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-58.50|-69.44|<0.001
72510185|NCT01953328|144550896|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-60.62|STANDARD_ERROR_OF_MEAN|2.47|<|0.001|TWO_SIDED|95.0|-65.51|-55.72||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-55.72|-65.51|<0.001
72510186|NCT01953328|144550897|SUPERIORITY_OR_OTHER||Treatment Difference|98.0|||<|0.001|TWO_SIDED|95.0|86.8|99.6||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on Cochran-Mantel Haenszel test stratified by the stratification factor (HeFH diagnosis and lipid-lowering therapy).||||99.6|86.8|<0.001
72510187|NCT01953328|144550897|SUPERIORITY_OR_OTHER||Treatment Difference|96.0|||<|0.001|TWO_SIDED|95.0|84.1|98.9||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on Cochran-Mantel Haenszel test stratified by the stratification factor (HeFH diagnosis and lipid-lowering therapy).||||98.9|84.1|<0.001
72510188|NCT01953328|144550897|SUPERIORITY_OR_OTHER||Treatment Difference|73.6|||<|0.001|TWO_SIDED|95.0|57.1|83.4||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on Cochran-Mantel Haenszel test stratified by the stratification factor (HeFH diagnosis and lipid-lowering therapy).||||83.4|57.1|<0.001
72510189|NCT01953328|144550897|SUPERIORITY_OR_OTHER||Treatment Difference|82.4|||<|0.001|TWO_SIDED|95.0|67.5|90.0||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on Cochran-Mantel Haenszel test stratified by the stratification factor (HeFH diagnosis and lipid-lowering therapy).||||90.0|67.5|<0.001
72510190|NCT01953328|144550898|SUPERIORITY_OR_OTHER||Treatment Difference|98.0|||<|0.001|TWO_SIDED|95.0|86.7|99.6||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on Cochran-Mantel Haenszel test stratified by the stratification factor (HeFH diagnosis and lipid-lowering therapy).||||99.6|86.7|<0.001
72566801|NCT02312713|144664437|SUPERIORITY||Mean Difference (Final Values)|1.12||||0.78|TWO_SIDED|95.0|-6.59|8.82|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Wait List Control at 12 months for the 2 Minute Step Test.||8.82|-6.59|0.78
72401785|NCT04865354|144310867|NON_INFERIORITY|Noninferiority to be concluded if least squares means difference upper confidence limit is less than 0.05.|Least Squares Mean Difference|0.003|STANDARD_ERROR_OF_MEAN|0.0034|||ONE_SIDED|95.0||0.009||Since a noninferiority hypothesis is being tested, a p-value is not applicable. Confidence limit is being reported and compared to the noninferiority margin.||LSM results based on general linear mixed effects model with terms for lens, period and sequence as fixed effects, subject as a random effect|Difference = PRECISION1 minus Clariti 1-Day|||0.009||
72566802|NCT02312713|144664437|SUPERIORITY||Mean Difference (Final Values)|4.88||||0.2|TWO_SIDED|95.0|-2.56|12.33|||Mixed Models Analysis|||This is the comparison between Internet Based Exercise Training and Wait List Control at 4 months for the 2 Minute Step Test.||12.33|-2.56|0.20
72566803|NCT02312713|144664437|SUPERIORITY||Mean Difference (Final Values)|1.13||||0.78|TWO_SIDED|95.0|-6.74|8.99|||Mixed Models Analysis|||This is the comparison between Internet Based Exercise Training and Wait List Control at 12 months for the 2 Minute Step Test.||8.99|-6.74|.78
72566804|NCT02312713|144664437|NON_INFERIORITY|Since there were not sufficient data in prior literature to specific an a priori non-inferiority margin, for this and other secondary outcomes we based conclusions and discussions on magnitude of differences between the group, descriptively. This strategy was specified in the protocol.|Mean Difference (Final Values)|-2.86||||0.35|TWO_SIDED|95.0|-8.94|3.21|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Internet Based Exercise Training at 4 months for the 2 Minute Step Test.||3.21|-8.94|0.35
72481277|NCT00325039|144489106|NON_INFERIORITY_OR_EQUIVALENCE|This study was an equivalence trial and was designed to have 80% power to show equivalence between the two sling procedures, with an equivalence margin of +/- 12 percentage points, at a two-sided significance level of 5%. The margin of +/- 12 was chosen on the basis of clinical considerations and a calculation of the number of patients it was feasible to enroll in the trial.|difference in success rate (RMUS-TMUS)|3.0|||||TWO_SIDED|95.0|-3.6|9.6||||||With 294 women/arm, the study would have 80% power to show equivalence between the two procedures, with an equivalence margin of +/- 12 percentage points, at a two-sided significance level of 5%. A planned time-to-event interim analysis of the primary outcome (objective treatment success) was conducted when 33% of the anticipated treatment failures occurred. We adjusted the primary outcome analysis for this interim look by assigning nominal alpha values of 0.049 to the 95% confidence intervals.||9.6|-3.6|
72481278|NCT00325039|144489107|SUPERIORITY_OR_OTHER||Difference in proportions|-4.1||||0.14||95.0||||This was not adjusted for multiple comparisons; the a priori threshold for statistical significance was 0.05.|Chi-squared|||Although the primary aim of the study was designed as an equivalence trial, the secondary aims were considered as superiority tests.||||0.14
72481279|NCT00325039|144489108|NON_INFERIORITY_OR_EQUIVALENCE|This study was an equivalence trial and was designed to have 80% power to show equivalence between the two sling procedures, with an equivalence margin of +/- 12 percentage points, at a two-sided significance level of 5%. The margin of +/- 12 was chosen on the basis of clinical considerations and a calculation of the number of patients it was feasible to enroll in the trial.|difference in success (RMUS - TMUS)|6.4|||||TWO_SIDED|95.0|-1.6|14.3||||||With 294 women/arm, the study would have 80% power to show equivalence between the two procedures, with an equivalence margin of +/- 12 percentage points, at a two-sided significance level of 5%. A planned time-to-event interim analysis of the primary outcome (objective treatment success) was conducted when 33% of the anticipated treatment failures occurred. We adjusted the primary outcome analysis for this interim look by assigning nominal alpha values of 0.049 to the 95% confidence intervals.||14.3|-1.6|
72481280|NCT00325039|144489109|SUPERIORITY_OR_OTHER|||||||0.47||95.0|||||t-test, 2 sided|||The null hypothesis is that the two arms do not differ according to quality of life, as measured by the IIQ.||||0.47
72481281|NCT00325039|144489110|SUPERIORITY_OR_OTHER|||||||0.41||95.0|||||t-test, 2 sided|||The UDI measure was compared using a two-sample t test.||||0.41
72481282|NCT00426153|144489114|SUPERIORITY_OR_OTHER|||||||0.048||95.0|||||Rank-sum test|||P values \<0.05 were considered statistically significant.||||0.048
72481283|NCT00426153|144489115|SUPERIORITY_OR_OTHER|||||||0.045||95.0||||P values \< 0.05 were considered statistically significant|Rank sum|||||||0.045
72481284|NCT00426153|144489116|SUPERIORITY_OR_OTHER|||||||0.98||95.0||||P Values \< 0.05 were considered statistically significant|Rank sum|||||||0.98
72481285|NCT00343252|144489133|SUPERIORITY_OR_OTHER|||||||0.642||95.0||||All comparisons were conducted using a 2-sided significance level of 0.05.|Chi-square|No adjustments for multiplicity were performed.||Tested the null hypothesis that there is no statistically significant difference between treatment groups in the proportion of participants with at least a 30% reduction in the severity of worst back pain from baseline to the 6-month endpoint.||||0.642
72481286|NCT00343252|144489134|SUPERIORITY_OR_OTHER|||||||0.683||95.0||||All comparisons were conducted using a 2-sided significance level of 0.05.|Chi-square|No adjustments for multiplicity were performed.||Tested the null hypothesis that there is no statistically significant difference between treatment groups in the proportion of participants with at least a 30% reduction in the severity of worst back pain from baseline at the 12-month endpoint.||||0.683
72481287|NCT00343252|144489135|SUPERIORITY_OR_OTHER|||||||0.809||95.0||||All comparisons were conducted using a 2-sided significance level of 0.05.|Chi-square|No adjustments for multiplicity were performed.||Tested the null hypothesis that there is no statistically significant difference between treatment groups in the proportion of participants with at least a 30% reduction in the severity of average back pain from baseline to the 6-month endpoint.||||0.809
72481288|NCT00343252|144489136|SUPERIORITY_OR_OTHER|||||||0.986||95.0||||All comparisons were conducted using a 2-sided significance level of 0.05.|Chi-square|No adjustments for multiplicity were performed.||Tested the null hypothesis that there is no statistically significant difference between treatment groups in the proportion of participants with at least a 30% reduction in the severity of average back pain from baseline to the 12-month endpoint.||||0.986
72566805|NCT02312713|144664437|NON_INFERIORITY|Since there were not sufficient data in prior literature to specific an a priori non-inferiority margin, for this and other secondary outcomes we based conclusions and discussions on magnitude of differences between the group, descriptively. This strategy was specified in the protocol.|Mean Difference (Final Values)|0.01||||1|TWO_SIDED|95.0|-6.4|6.42|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Internet Based Exercise Training at 12 months for the 2 Minute Step Test.||6.42|-6.40|1.00
72623981|NCT02231580|144778416|SUPERIORITY_OR_OTHER||GLS mean ratio|1.247|||=|0.2865|TWO_SIDED|90.0|0.886|1.756|||MMRM|||Left hand grip force variability statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||1.756|0.886|=0.2865
72481289|NCT00343252|144489137|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.03||||0.746|TWO_SIDED|95.0|0.85|1.26||Comparison of the Kaplan-Meier survival curves between treatment groups was conducted using log-rank, significance level of 0.05.|Log Rank|No adjustments for multiplicity were performed.||Tested the null hypothesis that there is no statistically significant difference between treatment groups in the time to first occurrence of a \>=30% reduction in worst back pain at the 6-month endpoint.||1.26|0.85|0.746
72481290|NCT00343252|144489138|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.03||||0.719|TWO_SIDED|95.0|0.86|1.25||Comparison of the Kaplan-Meier survival curves between treatment groups was conducted using log-rank, significance level of 0.05.|Log Rank|No adjustments for multiplicity were performed.||Tested the null hypothesis that there is no statistically significant difference between treatment groups in the time to first occurrence of a \>=30% reduction in worst back pain at the 12-month endpoint.||1.25|0.86|0.719
72481291|NCT00343252|144489139|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.04||||0.681|TWO_SIDED|95.0|0.86|1.26||Comparison of the Kaplan-Meier survival curves between treatment groups was conducted using log-rank, significance level of 0.05.|Log Rank|No adjustments for multiplicity were performed.||Tested the null hypothesis that there is no statistically significant difference between treatment groups in the time to first occurrence of a \>=30% reduction for average back pain at the 6-month endpoint.||1.26|0.86|0.681
72481292|NCT00343252|144489140|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.02||||0.789|TWO_SIDED|95.0|0.86|1.23||Comparison of the Kaplan-Meier survival curves between treatment groups was conducted using log-rank, significance level of 0.05.|Log Rank|No adjustments for multiplicity were performed.||Tested the null hypothesis that there is no statistically significant difference between treatment groups in the time to first occurrence of a \>=30% reduction in average back pain at the 12-month endpoint.||1.23|0.86|0.789
72481293|NCT00343252|144489141|SUPERIORITY_OR_OTHER|||||||0.968||95.0||||No adjustments for multiplicity were performed.|ANCOVA|The model includes terms for treatment, pooled site, baseline glucocorticoid usage status (yes/no), and baseline score.||Tested the null hypothesis that there is no statistically significant difference between the treatment groups in the proportion of participants with a reduction in disability at the 3-month endpoint.||||0.968
72481294|NCT00343252|144489142|SUPERIORITY_OR_OTHER|||||||0.568||95.0||||No adjustments for multiplicity were performed.|ANCOVA|The model includes terms for treatment, pooled site, baseline glucocorticoid usage status (yes/no), and baseline score.||Tested the null hypothesis that there is no statistically significant difference between treatment groups in the proportion of participants with a reduction in disability at the 6-month endpoint.||||0.568
72481295|NCT00343252|144489143|SUPERIORITY_OR_OTHER|||||||0.932||95.0||||No adjustments for multiplicity were performed.|ANCOVA|The model includes terms for treatment, pooled site, baseline glucocorticoid usage status (yes/no), and baseline score.||Tested the null hypothesis that there is no statistically significant difference between treatment groups in the proportion of participants with a reduction in disability at the 12-month endpoint.||||0.932
72481296|NCT00343252|144489144|SUPERIORITY_OR_OTHER|||||||0.814||95.0||||No adjustments for multiplicity were performed.|ANCOVA|The model includes terms for treatment, pooled site, baseline glucocorticoid usage status (yes/no), and baseline score.||Tested the null hypothesis that there is no statistically significant difference between treatment groups in the proportion of participants with an improvement in quality of life at the 6-month endpoint.||||0.814
72481297|NCT00343252|144489145|SUPERIORITY_OR_OTHER|||||||0.572||95.0||||No adjustments for multiplicity were performed.|ANCOVA|The model includes terms for treatment, pooled site, baseline glucocorticoid usage status (yes/no), and baseline score.||Tested the null hypothesis that there is no statistically significant difference between treatment groups in the proportion of participants with an improvement in quality of life at the 12-month endpoint.||||0.572
72481298|NCT00343252|144489148|SUPERIORITY_OR_OTHER|||||||0.6||95.0||||P-value is for responder versus non-responder.|Chi-squared|||||||0.600
72481299|NCT00343252|144489149|SUPERIORITY_OR_OTHER|||||||0.399||95.0||||P-value is for responder versus non-responder.|Chi-squared|||||||0.399
72481300|NCT00343252|144489150|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.07||||0.453|TWO_SIDED|95.0|0.89|1.28|||Log Rank|||||1.28|0.89|0.453
72481301|NCT00343252|144489151|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.09||||0.353|TWO_SIDED|95.0|0.91|1.3|||Log Rank|||||1.30|0.91|0.353
72369260|NCT00611026|144248562|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.2||0.0005|TWO_SIDED|95.0|-0.9|-0.3|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.|Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.|Treatment difference Tolterodine ER vs Fesoterodine at Week 4.||-0.3|-0.9|0.0005
72369261|NCT00611026|144248562|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001|TWO_SIDED|95.0|-1.5|-0.6|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.|Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.|Treatment difference fesoterodine vs placebo at Week 12.||-0.6|-1.5|<0.0001
72369262|NCT00611026|144248562|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.2||0.1467|TWO_SIDED|95.0|-0.7|0.1|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.|Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.|Treatment difference Tolterodine ER vs placebo at Week 12.||0.1|-0.7|0.1467
72481302|NCT00343252|144489152|SUPERIORITY_OR_OTHER|||||||0.943||95.0|||||ANCOVA|||||||0.943
72481303|NCT00343252|144489153|SUPERIORITY_OR_OTHER|||||||0.553||95.0|||||ANCOVA|||||||0.553
72481304|NCT00307125|144489250|SUPERIORITY_OR_OTHER||||||>|0.999|TWO_SIDED||||||Fisher Exact|||Analysis by Fisher's exact test counting participants with 50% decrease in anti-HLA antibodies at any time within 12 months post treatment initiation||||>0.999
72369263|NCT00611026|144248562|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001|TWO_SIDED|95.0|-1.1|-0.4|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.|Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.|Treatment difference Tolterodine ER vs Fesoterodine at Week 12.||-0.4|-1.1|<0.0001
72481305|NCT00307125|144489255|SUPERIORITY_OR_OTHER||||||>|0.999|TWO_SIDED||||||Fisher Exact|||||||>0.999
72481306|NCT00307125|144489256|SUPERIORITY_OR_OTHER||||||>|0.999|TWO_SIDED||||||Fisher Exact|||||||>0.999
72481307|NCT00051363|144489258|SUPERIORITY_OR_OTHER|||||||0.0074||||||"2M E/F Function- SWMT-OMD; P\<0.0307 indicates statistical significance for raw P values (after adjustment for O'Brien-Fleming spending across 3 interim analyses).~After correction for multiple comparisons (sequential Bonferroni) P Value=0.0444 (NS)"|Regression, Linear|Generalized Linear Models (GLM) were run by visit (2M and 6M).||Comparison of means (regression estimates) between arms for 2M E/F Function- SWMT-OMD.||||0.0074
72481308|NCT00051363|144489258|SUPERIORITY_OR_OTHER|||||||0.2254||||||6M E/F Function- SWMT-OMD; P\<0.0307 indicates statistical significance for raw P values (after adjustment for O'Brien-Fleming spending across 3 interim analyses).|Regression, Linear|Generalized Linear Models (GLM) were run by visit (2M and 6M).||Comparison of means (regression estimates) between arms for 6M E/F Function- SWMT-OMD.||||0.2254
72481309|NCT00051363|144489259|SUPERIORITY_OR_OTHER|||||||0.4538||||||DX A/P Function- PFN-TOTL; P\<0.0307 indicates statistical significance for raw P values (after adjustment for O'Brien-Fleming spending across 3 interim analyses).|Parametric survival analysis|Parametric survival analyses were conducted using by-visit comparisons for A/P Function- PFN-TOTL since these data were right censored at 60.||"Comparison of means (regression estimates) between arms for DX A/P Function- PFN-TOTL.~Data were reciprocal transformed for analysis and back-transformed for reporting."||||0.4538
72481310|NCT00051363|144489259|SUPERIORITY_OR_OTHER|||||||0.086||||||2M A/P Function- PFN-TOTL; P\<0.0307 indicates statistical significance for raw P values (after adjustment for O'Brien-Fleming spending across 3 interim analyses).|Parametric survival analysis|Parametric survival analyses were conducted using by-visit comparisons for A/P Function- PFN-TOTL since these data were right censored at 60.||"Comparison of means (regression estimates) between arms for 2M A/P Function- PFN-TOTL.~Data were reciprocal transformed for analysis and back-transformed for reporting."||||0.0860
72481311|NCT00051363|144489259|SUPERIORITY_OR_OTHER|||||||0.2103||||||6M A/P Function- PFN-TOTL; P\<0.0307 indicates statistical significance for raw P values (after adjustment for O'Brien-Fleming spending across 3 interim analyses).|Parametric survival analysis|Parametric survival analyses were conducted using by-visit comparisons for A/P Function- PFN-TOTL since these data were right censored at 60.||"Comparison of means (regression estimates) between arms for 6M A/P Function- PFN-TOTL.~Data were reciprocal transformed for analysis and back-transformed for reporting."||||0.2103
72481312|NCT00051363|144489260|SUPERIORITY_OR_OTHER|||||||0.7936||||||DX L/M Function- BSRT-SR; P\<0.0307 indicates statistical significance for raw P values (after adjustment for O'Brien-Fleming spending across 3 interim analyses).|Regression, Linear|Generalized Linear Models (GLM) were run by visit (2M and 6M).||Comparison of means (regression estimates) between arms for DX L/M Function- BSRT-SR.||||0.7936
72481313|NCT00051363|144489260|SUPERIORITY_OR_OTHER|||||||0.5444||||||2M L/M Function- BSRT-SR; P\<0.0307 indicates statistical significance for raw P values (after adjustment for O'Brien-Fleming spending across 3 interim analyses).|Regression, Linear|Generalized Linear Models (GLM) were run by visit (2M and 6M).||Comparison of means (regression estimates) between arms for 2M L/M Function- BSRT-SR.||||0.5444
72481314|NCT00051363|144489260|SUPERIORITY_OR_OTHER|||||||0.7569||||||6M L/M Function- BSRT-SR; P\<0.0307 indicates statistical significance for raw P values (after adjustment for O'Brien-Fleming spending across 3 interim analyses).|Regression, Linear|Generalized Linear Models (GLM) were run by visit (2M and 6M).||Comparison of means (regression estimates) between arms for 6M L/M Function- BSRT-SR.||||0.7569
72510191|NCT01953328|144550898|SUPERIORITY_OR_OTHER||Treatment Difference|91.8|||<|0.001|TWO_SIDED|95.0|78.2|96.0||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on Cochran-Mantel Haenszel test stratified by the stratification factor (HeFH diagnosis and lipid-lowering therapy).||||96.0|78.2|<0.001
72510192|NCT01953328|144550898|SUPERIORITY_OR_OTHER||Treatment Difference|75.6|||<|0.001|TWO_SIDED|95.0|59.3|85.0||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on Cochran-Mantel Haenszel test stratified by the stratification factor (HeFH diagnosis and lipid-lowering therapy).||||85.0|59.3|<0.001
72510193|NCT01953328|144550898|SUPERIORITY_OR_OTHER||Treatment Difference|78.0|||<|0.001|TWO_SIDED|95.0|62.6|86.9||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on Cochran-Mantel Haenszel test stratified by the stratification factor (HeFH diagnosis and lipid-lowering therapy).||||86.9|62.6|<0.001
72510194|NCT01953328|144550899|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-51.2|STANDARD_ERROR_OF_MEAN|6.39|<|0.001|TWO_SIDED|95.0|-63.88|-38.52||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-38.52|-63.88|<0.001
72510195|NCT01953328|144550899|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-49.08|STANDARD_ERROR_OF_MEAN|4.94|<|0.001|TWO_SIDED|95.0|-58.89|-39.27||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-39.27|-58.89|<0.001
72510196|NCT01953328|144550899|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-49.55|STANDARD_ERROR_OF_MEAN|5.14|<|0.001|TWO_SIDED|95.0|-59.74|-39.35||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-39.35|-59.74|<0.001
72510197|NCT01953328|144550899|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-43.93|STANDARD_ERROR_OF_MEAN|4.95|<|0.001|TWO_SIDED|95.0|-53.75|-34.12||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-34.12|-53.75|<0.001
72481315|NCT00051363|144489261|SUPERIORITY_OR_OTHER|||||||0.5606||||||"2M L/M Function- PN-RT (Mild OSA); P\<0.05 indicates statistical significance for P values.~Data were reciprocal transformed for analysis and back-transformed for reporting."|Mixed Models Analysis|Generalized Linear Mixed Models (GLMM) were utilized to account for repeated measures (DX, 2M, 6M).||"Comparison of means (regression estimates) between arms for covariate adjusted 2M L/M Function- PN-RT.~Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation \< 85% (PSG), age \< 60 years, WASI Verbal IQ, and WASI Performance IQ. A pre-randomization baseline PN-RT and months since randomization were also included as covariates."||||0.5606
72481316|NCT00051363|144489261|SUPERIORITY_OR_OTHER|||||||0.6487||||||"2M L/M Function- PN-RT (Moderate OSA); P\<0.05 indicates statistical significance for P values.~Data were reciprocal transformed for analysis and back-transformed for reporting."|Mixed Models Analysis|Generalized Linear Mixed Models (GLMM) were utilized to account for repeated measures (DX, 2M, 6M).||"Comparison of means (regression estimates) between arms for covariate adjusted 2M L/M Function- PN-RT.~Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation \< 85% (PSG), age \< 60 years, WASI Verbal IQ, and WASI Performance IQ. A pre-randomization baseline PN-RT and months since randomization were also included as covariates."||||0.6487
72481317|NCT00051363|144489261|SUPERIORITY_OR_OTHER|||||||0.5667||||||"2M L/M Function- PN-RT (Severe OSA); P\<0.05 indicates statistical significance for P values.~Data were reciprocal transformed for analysis and back-transformed for reporting."|Mixed Models Analysis|Generalized Linear Mixed Models (GLMM) were utilized to account for repeated measures (DX, 2M, 6M).||"Comparison of means (regression estimates) between arms for covariate adjusted 2M L/M Function- PN-RT.~Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation \< 85% (PSG), age \< 60 years, WASI Verbal IQ, and WASI Performance IQ. A pre-randomization baseline PN-RT and months since randomization were also included as covariates."||||0.5667
72510198|NCT01953328|144550900|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-50.07|STANDARD_ERROR_OF_MEAN|7.64|<|0.001|TWO_SIDED|95.0|-65.25|-34.9||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-34.90|-65.25|<0.001
72510199|NCT01953328|144550900|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-48.77|STANDARD_ERROR_OF_MEAN|5.9|<|0.001|TWO_SIDED|95.0|-60.49|-37.05||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-37.05|-60.49|<0.001
72510200|NCT01953328|144550900|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-52.68|STANDARD_ERROR_OF_MEAN|5.73|<|0.001|TWO_SIDED|95.0|-64.06|-41.3||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-41.30|-64.06|<0.001
72510201|NCT01953328|144550900|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-39.97|STANDARD_ERROR_OF_MEAN|5.29|<|0.001|TWO_SIDED|95.0|-50.46|-29.48||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-29.48|-50.46|<0.001
72510202|NCT01953328|144550901|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-27.93|STANDARD_ERROR_OF_MEAN|6.72|<|0.001|TWO_SIDED|95.0|-41.27|-14.59||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-14.59|-41.27|<0.001
72510203|NCT01953328|144550901|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-21.94|STANDARD_ERROR_OF_MEAN|5.34|<|0.001|TWO_SIDED|95.0|-32.54|-11.35||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-11.35|-32.54|<0.001
72510204|NCT01953328|144550901|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-20.01|STANDARD_ERROR_OF_MEAN|4.83|<|0.001|TWO_SIDED|95.0|-29.59|-10.43||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-10.43|-29.59|<0.001
72510205|NCT01953328|144550901|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-20.72|STANDARD_ERROR_OF_MEAN|6.78||0.01|TWO_SIDED|95.0|-34.18|-7.26||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-7.26|-34.18|0.010
72566806|NCT02312713|144664438|SUPERIORITY||Mean Difference (Final Values)|-0.63||||0.19|TWO_SIDED|95.0|-1.56|0.3|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Wait List Control at 4 months for Unilateral Stand Time.||0.30|-1.56|0.19
72481318|NCT00051363|144489261|SUPERIORITY_OR_OTHER|||||||0.3972||||||"6M L/M Function- PN-RT (Mild OSA); P\<0.05 indicates statistical significance for P values.~Data were reciprocal transformed for analysis and back-transformed for reporting."|Mixed Models Analysis|Generalized Linear Mixed Models (GLMM) were utilized to account for repeated measures (DX, 2M, 6M).||"Comparison of means (regression estimates) between arms for covariate adjusted 6M L/M Function- PN-RT.~Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation \< 85% (PSG), age \< 60 years, WASI Verbal IQ, and WASI Performance IQ. A pre-randomization baseline PN-RT and months since randomization were also included as covariates."||||0.3972
72481319|NCT00051363|144489261|SUPERIORITY_OR_OTHER|||||||0.3973||||||"6M L/M Function- PN-RT (Moderate OSA); P\<0.05 indicates statistical significance for P values.~Data were reciprocal transformed for analysis and back-transformed for reporting."|Mixed Models Analysis|Generalized Linear Mixed Models (GLMM) were utilized to account for repeated measures (DX, 2M, 6M).||"Comparison of means (regression estimates) between arms for covariate adjusted 6M L/M Function- PN-RT.~Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation \< 85% (PSG), age \< 60 years, WASI Verbal IQ, and WASI Performance IQ. A pre-randomization baseline PN-RT and months since randomization were also included as covariates."||||0.3973
72481320|NCT00051363|144489261|SUPERIORITY_OR_OTHER|||||||0.3055||||||"6M L/M Function- PN-RT (Moderate OSA); P\<0.05 indicates statistical significance for P values.~Data were reciprocal transformed for analysis and back-transformed for reporting."|Mixed Models Analysis|Generalized Linear Mixed Models (GLMM) were utilized to account for repeated measures (DX, 2M, 6M).||"Comparison of means (regression estimates) between arms for covariate adjusted 6M L/M Function- PN-RT.~Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation \< 85% (PSG), age \< 60 years, WASI Verbal IQ, and WASI Performance IQ. A pre-randomization baseline PN-RT and months since randomization were also included as covariates."||||0.3055
72510206|NCT01953328|144550902|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-27.57|STANDARD_ERROR_OF_MEAN|9.45|<|0.001|TWO_SIDED|95.0|-46.33|-8.81||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-8.81|-46.33|<0.001
72510207|NCT01953328|144550902|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-19.97|STANDARD_ERROR_OF_MEAN|5.9|<|0.001|TWO_SIDED|95.0|-31.68|-8.25||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-8.25|-31.68|<0.001
72510208|NCT01953328|144550902|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-17.17|STANDARD_ERROR_OF_MEAN|5.53|<|0.001|TWO_SIDED|95.0|-28.15|-6.19||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-6.19|-28.15|<0.001
72510209|NCT01953328|144550902|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-16.92|STANDARD_ERROR_OF_MEAN|7.24||0.01|TWO_SIDED|95.0|-31.29|-2.56||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-2.56|-31.29|0.010
72510210|NCT01953328|144550903|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|12.33|STANDARD_ERROR_OF_MEAN|2.49|<|0.001|TWO_SIDED|95.0|7.39|17.27||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||17.27|7.39|<0.001
72510211|NCT01953328|144550903|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|14.61|STANDARD_ERROR_OF_MEAN|2.36|<|0.001|TWO_SIDED|95.0|9.93|19.3||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||19.30|9.93|<0.001
72510212|NCT01953328|144550903|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|15.36|STANDARD_ERROR_OF_MEAN|2.64|<|0.001|TWO_SIDED|95.0|10.12|20.6||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||20.60|10.12|<0.001
72510213|NCT01953328|144550903|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|9.15|STANDARD_ERROR_OF_MEAN|2.26||0.001|TWO_SIDED|95.0|4.67|13.62||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||13.62|4.67|0.001
72510214|NCT01953328|144550904|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|13.46|STANDARD_ERROR_OF_MEAN|3.06|<|0.001|TWO_SIDED|95.0|7.4|19.53||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||19.53|7.40|<0.001
72510215|NCT01953328|144550904|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|15.2|STANDARD_ERROR_OF_MEAN|2.68|<|0.001|TWO_SIDED|95.0|9.87|20.52||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||20.52|9.87|<0.001
72566807|NCT02312713|144664438|SUPERIORITY||Mean Difference (Final Values)|0.04||||0.93|TWO_SIDED|95.0|-0.89|0.98|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Wait List Control at 12 months for Unilateral Stand Time.||0.98|-0.89|0.93
72510216|NCT01953328|144550904|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|16.85|STANDARD_ERROR_OF_MEAN|3.08|<|0.001|TWO_SIDED|95.0|10.74|22.95||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||22.95|10.74|<0.001
72510217|NCT01953328|144550904|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|10.2|STANDARD_ERROR_OF_MEAN|2.7||0.001|TWO_SIDED|95.0|4.85|15.55||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||15.55|4.85|0.001
72510218|NCT01953328|144550905|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-27.85|STANDARD_ERROR_OF_MEAN|5.8|<|0.001|TWO_SIDED|95.0|-39.37|-16.34||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-16.34|-39.37|<0.001
72510219|NCT01953328|144550905|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-22.65|STANDARD_ERROR_OF_MEAN|5.17|<|0.001|TWO_SIDED|95.0|-32.91|-12.39||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-12.39|-32.91|<0.001
72510220|NCT01953328|144550905|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-18.09|STANDARD_ERROR_OF_MEAN|4.69||0.001|TWO_SIDED|95.0|-27.4|-8.77||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-8.77|-27.40|0.001
72510221|NCT01953328|144550905|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-27.16|STANDARD_ERROR_OF_MEAN|6.12|<|0.001|TWO_SIDED|95.0|-39.31|-15.01||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-15.01|-39.31|<0.001
72510222|NCT01953328|144550906|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-28.42|STANDARD_ERROR_OF_MEAN|7.08|<|0.001|TWO_SIDED|95.0|-42.48|-14.36||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-14.36|-42.48|<0.001
72510223|NCT01953328|144550906|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-20.81|STANDARD_ERROR_OF_MEAN|5.78|<|0.001|TWO_SIDED|95.0|-32.29|-9.33||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-9.33|-32.29|<0.001
72510224|NCT01953328|144550906|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-15.05|STANDARD_ERROR_OF_MEAN|5.37||0.001|TWO_SIDED|95.0|-25.72|-4.39||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-4.39|-25.72|0.001
72566808|NCT02312713|144664438|SUPERIORITY||Mean Difference (Final Values)|-0.02||||0.97|TWO_SIDED|95.0|-0.97|0.93|||Mixed Models Analysis|||This is the comparison between Internet Based Exercise Training and Wait List Control at 4 months for Unilateral Stand Time.||0.93|-0.97|0.97
72401786|NCT01925404|144310868|SUPERIORITY|We fitted difference-in-differences (DID) models between the two measurement waves and four study arms. The effect of the intervention was modeled as the wave by study arm interaction. All models used random effects to account for intra-class correlation within each park as well as fixed effects to account for observation times (time of day, weekend versus weekdays).||||||0.0063||||||Significance threshold. p=0.05|negative binomial distribution|||Comparison of change from baseline;||||.0063
72510225|NCT01953328|144550906|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-24.35|STANDARD_ERROR_OF_MEAN|6.22|<|0.001|TWO_SIDED|95.0|-36.7|-11.99||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-11.99|-36.70|<0.001
72510226|NCT04710862|144550922|SUPERIORITY||||||<|0.0005|||||||Mixed Models Analysis|||||||<0.0005
72510227|NCT04710862|144550923|SUPERIORITY||||||<|0.0005|||||||Mixed Models Analysis|||||||<0.0005
72510228|NCT04710862|144550924|SUPERIORITY|||||||0.012|||||||Mixed Models Analysis|||||||0.012
72510229|NCT04710862|144550925|SUPERIORITY|||||||0.001|||||||Mixed Models Analysis|||||||0.001
72510230|NCT04710862|144550926|SUPERIORITY|||||||0.004|||||||Mixed Models Analysis|||||||0.004
72566809|NCT02312713|144664438|SUPERIORITY||Mean Difference (Final Values)|0.04||||0.93|TWO_SIDED|95.0|-0.91|1.0|||Mixed Models Analysis|||This is the comparison between Internet Based Exercise Training and Wait List Control at 12 months for Unilateral Stand Time||1|-0.91|0.93
72566810|NCT02312713|144664438|NON_INFERIORITY|Since there were not sufficient data in prior literature to specific an a priori non-inferiority margin, for this and other secondary outcomes we based conclusions and discussions on magnitude of differences between the group, descriptively. This strategy was specified in the protocol.|Mean Difference (Final Values)|0.61||||0.12|TWO_SIDED|95.0|-0.16|1.38|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Internet Based Exercise Training at 4 months for Unilateral Stand Time.||1.38|-0.16|0.12
72510231|NCT04710862|144550927|SUPERIORITY|||||||0.001|||||||Mixed Models Analysis|||||||0.001
72510232|NCT04710862|144550928|SUPERIORITY|||||||0.328|||||||Mixed Models Analysis|||||||0.328
72481321|NCT00051363|144489262|SUPERIORITY_OR_OTHER|||||||0.3699||||||"2M A/P Function- PVT-MedRT (Mild OSA); P\<0.05 indicates statistical significance for P values.~Data were reciprocal transformed for analysis and back-transformed for reporting."|Mixed Models Analysis|Generalized Linear Mixed Models (GLMM) were utilized to account for repeated measures (DX, 2M, 6M).||"Comparison of means (regression estimates) between arms for covariate adjusted 2M A/P Function- PVT-MedRT.~Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation \< 85% (PSG), age \< 60 years, WASI Verbal IQ, and WASI Performance IQ. Months since randomization were also included as covariate."||||0.3699
72481322|NCT00051363|144489262|SUPERIORITY_OR_OTHER|||||||0.9673||||||"2M A/P Function- PVT-MedRT (Moderate OSA); P\<0.05 indicates statistical significance for P values.~Data were reciprocal transformed for analysis and back-transformed for reporting."|Mixed Models Analysis|Generalized Linear Mixed Models (GLMM) were utilized to account for repeated measures (DX, 2M, 6M).||"Comparison of means (regression estimates) between arms for covariate adjusted 2M A/P Function- PVT-MedRT.~Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation \< 85% (PSG), age \< 60 years, WASI Verbal IQ, and WASI Performance IQ. Months since randomization were also included as covariate."||||0.9673
72481323|NCT00051363|144489262|SUPERIORITY_OR_OTHER|||||||0.3426||||||"2M A/P Function- PVT-MedRT (Severe OSA); P\<0.05 indicates statistical significance for P values.~Data were reciprocal transformed for analysis and back-transformed for reporting."|Mixed Models Analysis|Generalized Linear Mixed Models (GLMM) were utilized to account for repeated measures (DX, 2M, 6M).||"Comparison of means (regression estimates) between arms for covariate adjusted 2M A/P Function- PVT-MedRT.~Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation \< 85% (PSG), age \< 60 years, WASI Verbal IQ, and WASI Performance IQ. Months since randomization were also included as covariate."||||0.3426
72481324|NCT00051363|144489262|SUPERIORITY_OR_OTHER|||||||0.3901||||||"6M A/P Function- PVT-MedRT (Mild OSA); P\<0.05 indicates statistical significance for P values.~Data were reciprocal transformed for analysis and back-transformed for reporting."|Mixed Models Analysis|Generalized Linear Mixed Models (GLMM) were utilized to account for repeated measures (DX, 2M, 6M).||"Comparison of means (regression estimates) between arms for covariate adjusted 2M A/P Function- PVT-MedRT.~Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation \< 85% (PSG), age \< 60 years, WASI Verbal IQ, and WASI Performance IQ. Months since randomization were also included as covariate."||||0.3901
72481325|NCT00051363|144489262|SUPERIORITY_OR_OTHER|||||||0.9464||||||"6M A/P Function- PVT-MedRT (Moderate OSA); P\<0.05 indicates statistical significance for P values.~Data were reciprocal transformed for analysis and back-transformed for reporting."|Mixed Models Analysis|Generalized Linear Mixed Models (GLMM) were utilized to account for repeated measures (DX, 2M, 6M).||"Comparison of means (regression estimates) between arms for covariate adjusted 2M A/P Function- PVT-MedRT.~Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation \< 85% (PSG), age \< 60 years, WASI Verbal IQ, and WASI Performance IQ. Months since randomization were also included as covariate."||||0.9464
72481326|NCT00051363|144489262|SUPERIORITY_OR_OTHER|||||||0.4372||||||"6M A/P Function- PVT-MedRT (Severe OSA); P\<0.05 indicates statistical significance for P values.~Data were reciprocal transformed for analysis and back-transformed for reporting."|Mixed Models Analysis|Generalized Linear Mixed Models (GLMM) were utilized to account for repeated measures (DX, 2M, 6M).||"Comparison of means (regression estimates) between arms for covariate adjusted 2M A/P Function- PVT-MedRT.~Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation \< 85% (PSG), age \< 60 years, WASI Verbal IQ, and WASI Performance IQ. Months since randomization were also included as covariate."||||0.4372
72510233|NCT02364947|144550931|SUPERIORITY_OR_OTHER_LEGACY|Mixed model for repeated measures (MMRM) with fixed effect of treatment, sex, time point, treatment-by-time point interaction, baseline value, and baseline value-by-time point interaction with an unstructured variance-covariance matrix structure was used.|Mean Difference (Final Values)|-4.34|STANDARD_ERROR_OF_MEAN|0.87||0.0001|TWO_SIDED|95.0|-6.05|-2.62||Efficacy of the doses (change from baseline in the number of HDDs vs placebo) was assessed using a closed testing procedure. The 20 mg dose was tested at a 5% level of significance and only if significant, the testing would proceed to the 10 mg dose.|Mixed Models Analysis|||||-2.62|-6.05|0.0001
72510234|NCT02364947|144550931|SUPERIORITY_OR_OTHER_LEGACY|Mixed model for repeated measures (MMRM) with fixed effect of treatment, sex, time point, treatment-by-time point interaction, baseline value, and baseline value-by-time point interaction with an unstructured variance-covariance matrix structure was used.|Mean Difference (Final Values)|-4.18|STANDARD_ERROR_OF_MEAN|0.95||0.0001|TWO_SIDED|95.0|-6.05|-2.32||Efficacy of the doses (change from baseline in the number of HDDs vs placebo) was assessed using a closed testing procedure. The 20 mg dose was tested at a 5% level of significance and only if significant, the testing would proceed to the 10 mg dose.|Mixed Models Analysis|||||-2.32|-6.05|0.0001
72510235|NCT02364947|144550932|SUPERIORITY_OR_OTHER_LEGACY|Mixed model for repeated measures (MMRM) with fixed effect of treatment, sex, time point, treatment-by-time point interaction, baseline value, and baseline value-by-time point interaction with an unstructured variance-covariance matrix structure was used.|Mean Difference (Final Values)|-3.92|STANDARD_ERROR_OF_MEAN|0.9|<|0.0001|TWO_SIDED|95.0|-5.69|-2.16|||Mixed Models Analysis|||||-2.16|-5.69|<0.0001
72510236|NCT02364947|144550932|SUPERIORITY_OR_OTHER_LEGACY|Mixed model for repeated measures (MMRM) with fixed effect of treatment, sex, time point, treatment-by-time point interaction, baseline value, and baseline value-by-time point interaction with an unstructured variance-covariance matrix structure was used.|Mean Difference (Final Values)|-4.54|STANDARD_ERROR_OF_MEAN|0.98|<|0.0001|TWO_SIDED|95.0|-6.46|-2.63|||Mixed Models Analysis|||||-2.63|-6.46|<0.0001
72481327|NCT00051363|144489263|SUPERIORITY_OR_OTHER|||||||0.9656||||||"2M A/P Function- PVT-Slo10%RT (Mild OSA); P\<0.05 indicates statistical significance for P values.~Data were reciprocal transformed for analysis and back-transformed for reporting."|Mixed Models Analysis|Generalized Linear Mixed Models (GLMM) were utilized to account for repeated measures (DX, 2M, 6M).||"Comparison of means (regression estimates) between arms for covariate adjusted 2M A/P Function- PVT-Slo10%RT.~Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation \< 85% (PSG), age \< 60 years, WASI Verbal IQ, and WASI Performance IQ. Months since randomization were also included as covariate."||||0.9656
72481328|NCT00051363|144489263|SUPERIORITY_OR_OTHER|||||||0.6765||||||"2M A/P Function- PVT-Slo10%RT (Moderate OSA); P\<0.05 indicates statistical significance for P values.~Data were reciprocal transformed for analysis and back-transformed for reporting."|Mixed Models Analysis|Generalized Linear Mixed Models (GLMM) were utilized to account for repeated measures (DX, 2M, 6M).||"Comparison of means (regression estimates) between arms for covariate adjusted 2M A/P Function- PVT-Slo10%RT.~Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation \< 85% (PSG), age \< 60 years, WASI Verbal IQ, and WASI Performance IQ. Months since randomization were also included as covariate."||||0.6765
72481329|NCT00051363|144489263|SUPERIORITY_OR_OTHER|||||||0.5288||||||"2M A/P Function- PVT-Slo10%RT (Severe OSA); P\<0.05 indicates statistical significance for P values.~Data were reciprocal transformed for analysis and back-transformed for reporting."|Mixed Models Analysis|Generalized Linear Mixed Models (GLMM) were utilized to account for repeated measures (DX, 2M, 6M).||"Comparison of means (regression estimates) between arms for covariate adjusted 2M A/P Function- PVT-Slo10%RT.~Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation \< 85% (PSG), age \< 60 years, WASI Verbal IQ, and WASI Performance IQ. Months since randomization were also included as covariate."||||0.5288
72481330|NCT00051363|144489263|SUPERIORITY_OR_OTHER|||||||0.7807||||||"6M A/P Function- PVT-Slo10%RT (Mild OSA); P\<0.05 indicates statistical significance for P values.~Data were reciprocal transformed for analysis and back-transformed for reporting."|Mixed Models Analysis|Generalized Linear Mixed Models (GLMM) were utilized to account for repeated measures (DX, 2M, 6M).||"Comparison of means (regression estimates) between arms for covariate adjusted 2M A/P Function- PVT-Slo10%RT.~Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation \< 85% (PSG), age \< 60 years, WASI Verbal IQ, and WASI Performance IQ. Months since randomization were also included as covariate."||||0.7807
72481331|NCT00051363|144489263|SUPERIORITY_OR_OTHER|||||||0.9603||||||"6M A/P Function- PVT-Slo10%RT (Moderate OSA); P\<0.05 indicates statistical significance for P values.~Data were reciprocal transformed for analysis and back-transformed for reporting."|Mixed Models Analysis|Generalized Linear Mixed Models (GLMM) were utilized to account for repeated measures (DX, 2M, 6M).||"Comparison of means (regression estimates) between arms for covariate adjusted 2M A/P Function- PVT-Slo10%RT.~Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation \< 85% (PSG), age \< 60 years, WASI Verbal IQ, and WASI Performance IQ. Months since randomization were also included as covariate."||||0.9603
72481332|NCT00051363|144489263|SUPERIORITY_OR_OTHER|||||||0.3075||||||"6M A/P Function- PVT-Slo10%RT (Severe OSA); P\<0.05 indicates statistical significance for P values.~Data were reciprocal transformed for analysis and back-transformed for reporting."|Mixed Models Analysis|Generalized Linear Mixed Models (GLMM) were utilized to account for repeated measures (DX, 2M, 6M).||"Comparison of means (regression estimates) between arms for covariate adjusted 2M A/P Function- PVT-Slo10%RT.~Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation \< 85% (PSG), age \< 60 years, WASI Verbal IQ, and WASI Performance IQ. Months since randomization were also included as covariate."||||0.3075
72481333|NCT00051363|144489264|SUPERIORITY_OR_OTHER|||||||0.4262||||||2M L/M Function- BSRTDR-TotRec (Mild OSA); P\<0.05 indicates statistical significance for P values.|Regression, Linear|Generalized Linear Models (GLM) were run by visit (2M and 6M).||"Comparison of means (regression estimates) between arms for covariate adjusted 2M L/M Function- BSRTDR-TotRec.~Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation \< 85% (PSG), age \< 60 years, WASI Verbal IQ, and WASI Performance IQ. A pre-randomization baseline BSRTDR-TotRec was also included as a covariate."||||0.4262
72510237|NCT02364947|144550933|SUPERIORITY_OR_OTHER_LEGACY|Mixed model for repeated measures (MMRM) with fixed effect of treatment, sex, time point, treatment-by-time point interaction, baseline value, and baseline value-by-time point interaction with an unstructured variance-covariance matrix structure was used.|Mean Difference (Final Values)|-12.47|STANDARD_ERROR_OF_MEAN|2.72|<|0.0001|TWO_SIDED|95.0|-17.81|-7.13|||Mixed Models Analysis|||Change in total alcohol consumption (TAC) from baseline at Week 12||-7.13|-17.81|<0.0001
72510238|NCT02364947|144550933|SUPERIORITY_OR_OTHER_LEGACY|Mixed model for repeated measures (MMRM) with fixed effect of treatment, sex, time point, treatment-by-time point interaction, baseline value, and baseline value-by-time point interaction with an unstructured variance-covariance matrix structure was used.|Mean Difference (Final Values)|-12.94|STANDARD_ERROR_OF_MEAN|2.95|<|0.0001|TWO_SIDED|95.0|-18.72|-7.15|||Mixed Models Analysis|||||-7.15|-18.72|<0.0001
72401787|NCT00706641|144310872|SUPERIORITY_OR_OTHER|||||||0.003|TWO_SIDED||||||paired t-test|||Tumor samples from 20 patients were analyzed for expression of pSFK. A paired t-Test was used to calculate the significance of the difference in expression levels before and after treatment.||||0.003
72401788|NCT00706641|144310875|SUPERIORITY_OR_OTHER|||||||0.2|TWO_SIDED||||||paired t-test|||||||0.20
72401789|NCT00706641|144310876|SUPERIORITY_OR_OTHER|||||||0.42|TWO_SIDED||||||paired t-test|||||||0.42
72401790|NCT02094716|144310931|SUPERIORITY|||||||0.6084|||||||Chi-squared|||||||0.6084
72481334|NCT00051363|144489264|SUPERIORITY_OR_OTHER|||||||0.3161||||||2M L/M Function- BSRTDR-TotRec (Moderate OSA); P\<0.05 indicates statistical significance for P values.|Regression, Linear|Generalized Linear Models (GLM) were run by visit (2M and 6M).||"Comparison of means (regression estimates) between arms for covariate adjusted 2M L/M Function- BSRTDR-TotRec.~Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation \< 85% (PSG), age \< 60 years, WASI Verbal IQ, and WASI Performance IQ. A pre-randomization baseline BSRTDR-TotRec was also included as a covariate."||||0.3161
72481335|NCT00051363|144489264|SUPERIORITY_OR_OTHER|||||||0.1835||||||2M L/M Function- BSRTDR-TotRec (Severe OSA); P\<0.05 indicates statistical significance for P values.|Regression, Linear|Generalized Linear Models (GLM) were run by visit (2M and 6M).||"Comparison of means (regression estimates) between arms for covariate adjusted 2M L/M Function- BSRTDR-TotRec.~Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation \< 85% (PSG), age \< 60 years, WASI Verbal IQ, and WASI Performance IQ. A pre-randomization baseline BSRTDR-TotRec was also included as a covariate."||||0.1835
72481336|NCT00051363|144489264|SUPERIORITY_OR_OTHER|||||||0.2462||||||6M L/M Function- BSRTDR-TotRec (Mild OSA); P\<0.05 indicates statistical significance for P values.|Regression, Linear|Generalized Linear Models (GLM) were run by visit (2M and 6M).||"Comparison of means (regression estimates) between arms for covariate adjusted 2M L/M Function- BSRTDR-TotRec.~Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation \< 85% (PSG), age \< 60 years, WASI Verbal IQ, and WASI Performance IQ. A pre-randomization baseline BSRTDR-TotRec was also included as a covariate."||||0.2462
72481337|NCT00051363|144489264|SUPERIORITY_OR_OTHER|||||||0.2069||||||6M L/M Function- BSRTDR-TotRec (Moderate OSA); P\<0.05 indicates statistical significance for P values.|Regression, Linear|Generalized Linear Models (GLM) were run by visit (2M and 6M).||"Comparison of means (regression estimates) between arms for covariate adjusted 2M L/M Function- BSRTDR-TotRec.~Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation \< 85% (PSG), age \< 60 years, WASI Verbal IQ, and WASI Performance IQ. A pre-randomization baseline BSRTDR-TotRec was also included as a covariate."||||0.2069
72481338|NCT00051363|144489264|SUPERIORITY_OR_OTHER|||||||0.5235||||||6M L/M Function- BSRTDR-TotRec (Severe OSA); P\<0.05 indicates statistical significance for P values.|Regression, Linear|Generalized Linear Models (GLM) were run by visit (2M and 6M).||"Comparison of means (regression estimates) between arms for covariate adjusted 2M L/M Function- BSRTDR-TotRec.~Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation \< 85% (PSG), age \< 60 years, WASI Verbal IQ, and WASI Performance IQ. A pre-randomization baseline BSRTDR-TotRec was also included as a covariate."||||0.5235
72481339|NCT00051363|144489265|SUPERIORITY_OR_OTHER|||||||0.5419||||||2M E/F Function- SWMT-BehMD (Mild OSA); P\<0.05 indicates statistical significance for P values.|Regression, Linear|Generalized Linear Models (GLM) were run by visit (2M and 6M).||"Comparison of means (regression estimates) between arms for covariate adjusted 2M E/F Function- SWMT-BehMD.~Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation \< 85% (PSG), age \< 60 years, WASI Verbal IQ, and WASI Performance IQ."||||0.5419
72510239|NCT02364947|144550934|SUPERIORITY_OR_OTHER_LEGACY|Mixed model for repeated measures (MMRM) with fixed effect of treatment, sex, time point, treatment-by-time point interaction, baseline value, and baseline value-by-time point interaction with an unstructured variance-covariance matrix structure was used.|Mean Difference (Final Values)|-11.15|STANDARD_ERROR_OF_MEAN|2.86||0.0001|TWO_SIDED|95.0|-16.77|-5.53|||Mixed Models Analysis|||||-5.53|-16.77|0.0001
72401791|NCT02094716|144310933|SUPERIORITY|||||||0.6937|||||||Chi-squared|||||||0.6937
72401792|NCT02094716|144310934|SUPERIORITY|||||||0.101|||||||Fisher Exact|||||||0.1010
72481340|NCT00051363|144489265|SUPERIORITY_OR_OTHER|||||||0.89||||||2M E/F Function- SWMT-BehMD (Moderate OSA); P\<0.05 indicates statistical significance for P values.|Regression, Linear|Generalized Linear Models (GLM) were run by visit (2M and 6M).||"Comparison of means (regression estimates) between arms for covariate adjusted 2M E/F Function- SWMT-BehMD.~Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation \< 85% (PSG), age \< 60 years, WASI Verbal IQ, and WASI Performance IQ."||||0.8900
72481341|NCT00051363|144489265|SUPERIORITY_OR_OTHER|||||||0.0031||||||2M E/F Function- SWMT-BehMD (Severe OSA); P\<0.05 indicates statistical significance for P values.|Regression, Linear|Generalized Linear Models (GLM) were run by visit (2M and 6M).||"Comparison of means (regression estimates) between arms for covariate adjusted 2M E/F Function- SWMT-BehMD.~Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation \< 85% (PSG), age \< 60 years, WASI Verbal IQ, and WASI Performance IQ."||||0.0031
72481342|NCT00051363|144489265|SUPERIORITY_OR_OTHER|||||||0.8703||||||6M E/F Function- SWMT-BehMD (Mild OSA); P\<0.05 indicates statistical significance for P values.|Regression, Linear|Generalized Linear Models (GLM) were run by visit (2M and 6M).||"Comparison of means (regression estimates) between arms for covariate adjusted 6M E/F Function- SWMT-BehMD.~Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation \< 85% (PSG), age \< 60 years, WASI Verbal IQ, and WASI Performance IQ."||||0.8703
72481343|NCT00051363|144489265|SUPERIORITY_OR_OTHER|||||||0.1838||||||6M E/F Function- SWMT-BehMD (Moderate OSA); P\<0.05 indicates statistical significance for P values.|Regression, Linear|Generalized Linear Models (GLM) were run by visit (2M and 6M).||"Comparison of means (regression estimates) between arms for covariate adjusted 6M E/F Function- SWMT-BehMD.~Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation \< 85% (PSG), age \< 60 years, WASI Verbal IQ, and WASI Performance IQ."||||0.1838
72510240|NCT02364947|144550934|SUPERIORITY_OR_OTHER_LEGACY|Mixed model for repeated measures (MMRM) with fixed effect of treatment, sex, time point, treatment-by-time point interaction, baseline value, and baseline value-by-time point interaction with an unstructured variance-covariance matrix structure was used.|Mean Difference (Final Values)|-11.27|STANDARD_ERROR_OF_MEAN|3.11||0.0003|TWO_SIDED|95.0|-17.37|-5.17|||Mixed Models Analysis|||||-5.17|-17.37|0.0003
72510241|NCT02364947|144550935|SUPERIORITY_OR_OTHER_LEGACY|Cochran-Mantel-Haenszel test, stratified by sex and baseline DRL|Risk Difference (RD)|22.0|||<|0.0001|TWO_SIDED|95.0|13.6|30.4|||Cochran-Mantel-Haenszel|||||30.4|13.6|<0.0001
72481344|NCT00051363|144489265|SUPERIORITY_OR_OTHER|||||||0.0739||||||6M E/F Function- SWMT-BehMD (Severe OSA); P\<0.05 indicates statistical significance for P values.|Regression, Linear|Generalized Linear Models (GLM) were run by visit (2M and 6M).||"Comparison of means (regression estimates) between arms for covariate adjusted 6M E/F Function- SWMT-BehMD.~Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation \< 85% (PSG), age \< 60 years, WASI Verbal IQ, and WASI Performance IQ."||||0.0739
72510242|NCT02364947|144550935|SUPERIORITY_OR_OTHER_LEGACY|Cochran-Mantel-Haenszel test, stratified by sex and baseline DRL|Risk Difference (RD)|15.7||||0.0007|TWO_SIDED|95.0|6.5|25.0|||Cochran-Mantel-Haenszel|||||25.0|6.5|0.0007
72510243|NCT02364947|144550936|SUPERIORITY_OR_OTHER_LEGACY|Cochran-Mantel-Haenszel test, stratified by sex and baseline DRL|Risk Difference (RD)|18.0||||0.0002|TWO_SIDED|95.0|8.8|27.2|||Cochran-Mantel-Haenszel|||||27.2|8.8|0.0002
72510244|NCT02364947|144550936|SUPERIORITY_OR_OTHER_LEGACY|Cochran-Mantel-Haenszel test, stratified by sex and baseline DRL|Risk Difference (RD)|20.6||||0.0001|TWO_SIDED|95.0|10.4|30.8|||Cochran-Mantel-Haenszel|||||30.8|10.4|0.0001
72510245|NCT02364947|144550937|SUPERIORITY_OR_OTHER_LEGACY|Cochran-Mantel-Haenszel test, stratified by sex and baseline DRL|Risk Difference (RD)|17.8|||<|0.0001|TWO_SIDED|95.0|10.5|25.1|||Cochran-Mantel-Haenszel|||||25.1|10.5|<0.0001
72510246|NCT02364947|144550937|SUPERIORITY_OR_OTHER_LEGACY|Cochran-Mantel-Haenszel test, stratified by sex and baseline DRL|Risk Difference (RD)|14.3||||0.0002|TWO_SIDED|95.0|6.4|22.2|||Cochran-Mantel-Haenszel|||||22.2|6.4|0.0002
72510247|NCT02364947|144550938|SUPERIORITY_OR_OTHER_LEGACY|Cochran-Mantel-Haenszel test, stratified by sex and baseline DRL|Risk Difference (RD)|11.0||||0.0079|TWO_SIDED|95.0|2.9|19.1|||Cochran-Mantel-Haenszel|||||19.1|2.9|0.0079
72510248|NCT02364947|144550938|SUPERIORITY_OR_OTHER_LEGACY|Cochran-Mantel-Haenszel test, stratified by sex and baseline DRL|Risk Difference (RD)|14.8||||0.001|TWO_SIDED|95.0|5.8|23.9|||Cochran-Mantel-Haenszel|||||23.9|5.8|0.0010
72401793|NCT02094716|144310934|SUPERIORITY|||||||0.0764|||||||Fisher Exact|||||||0.0764
72481345|NCT00051363|144489266|SUPERIORITY_OR_OTHER|||||||0.045||||||2M E/F Function- SWMT-ActMD (Mild OSA); P\<0.05 indicates statistical significance for P values.|Regression, Linear|Generalized Linear Models (GLM) were run by visit (2M and 6M).||"Comparison of means (regression estimates) between arms for covariate adjusted 2M E/F Function- SWMT-ActMD.~Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation \< 85% (PSG), age \< 60 years, WASI Verbal IQ, and WASI Performance IQ."||||0.0450
72481346|NCT00051363|144489266|SUPERIORITY_OR_OTHER|||||||0.4512||||||2M E/F Function- SWMT-ActMD (Moderate OSA); P\<0.05 indicates statistical significance for P values.|Regression, Linear|Generalized Linear Models (GLM) were run by visit (2M and 6M).||"Comparison of means (regression estimates) between arms for covariate adjusted 2M E/F Function- SWMT-ActMD.~Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation \< 85% (PSG), age \< 60 years, WASI Verbal IQ, and WASI Performance IQ."||||0.4512
72481347|NCT00051363|144489266|SUPERIORITY_OR_OTHER|||||||0.6672||||||2M E/F Function- SWMT-ActMD (Severe OSA); P\<0.05 indicates statistical significance for P values.|Regression, Linear|Generalized Linear Models (GLM) were run by visit (2M and 6M).||"Comparison of means (regression estimates) between arms for covariate adjusted 2M E/F Function- SWMT-ActMD.~Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation \< 85% (PSG), age \< 60 years, WASI Verbal IQ, and WASI Performance IQ."||||0.6672
72481348|NCT00051363|144489266|SUPERIORITY_OR_OTHER|||||||0.8197||||||6M E/F Function- SWMT-ActMD (Mild OSA); P\<0.05 indicates statistical significance for P values.|Regression, Linear|Generalized Linear Models (GLM) were run by visit (2M and 6M).||"Comparison of means (regression estimates) between arms for covariate adjusted 6M E/F Function- SWMT-ActMD.~Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation \< 85% (PSG), age \< 60 years, WASI Verbal IQ, and WASI Performance IQ."||||0.8197
72481349|NCT00051363|144489266|SUPERIORITY_OR_OTHER|||||||0.989||||||6M E/F Function- SWMT-ActMD (Moderate OSA); P\<0.05 indicates statistical significance for P values.|Regression, Linear|Generalized Linear Models (GLM) were run by visit (2M and 6M).||"Comparison of means (regression estimates) between arms for covariate adjusted 6M E/F Function- SWMT-ActMD.~Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation \< 85% (PSG), age \< 60 years, WASI Verbal IQ, and WASI Performance IQ."||||0.9890
72510249|NCT02364947|144550939|SUPERIORITY_OR_OTHER_LEGACY|Cochran-Mantel-Haenszel test, stratified by sex and baseline value|Risk Difference (RD)|9.9||||0.0022|TWO_SIDED|95.0|3.5|16.3|||Cochran-Mantel-Haenszel|||||16.3|3.5|0.0022
72510250|NCT02364947|144550939|SUPERIORITY_OR_OTHER_LEGACY|Cochran-Mantel-Haenszel test, stratified by sex and baseline value|Risk Difference (RD)|11.1||||0.0016|TWO_SIDED|95.0|3.8|18.3|||Cochran-Mantel-Haenszel|||||18.3|3.8|0.0016
72481350|NCT00051363|144489266|SUPERIORITY_OR_OTHER|||||||0.5029||||||6M E/F Function- SWMT-ActMD (Severe OSA); P\<0.05 indicates statistical significance for P values.|Regression, Linear|Generalized Linear Models (GLM) were run by visit (2M and 6M).||"Comparison of means (regression estimates) between arms for covariate adjusted 6M E/F Function- SWMT-ActMD.~Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation \< 85% (PSG), age \< 60 years, WASI Verbal IQ, and WASI Performance IQ."||||0.5029
72510251|NCT02364947|144550940|SUPERIORITY_OR_OTHER_LEGACY|Cochran-Mantel-Haenszel test, stratified by sex and baseline value|Risk Difference (RD)|13.6||||0.0003|TWO_SIDED|95.0|6.2|20.9|||Cochran-Mantel-Haenszel|||||20.9|6.2|0.0003
72510252|NCT02364947|144550940|SUPERIORITY_OR_OTHER_LEGACY|Cochran-Mantel-Haenszel test, stratified by sex and baseline value|Risk Difference (RD)|12.8||||0.0013|TWO_SIDED|95.0|4.6|21.0|||Cochran-Mantel-Haenszel|||||21.0|4.6|0.0013
72510253|NCT02364947|144550941|SUPERIORITY_OR_OTHER_LEGACY|Cochran-Mantel-Haenszel test, stratified by sex and baseline value|Risk Difference (RD)|15.2||||0.0002|TWO_SIDED|95.0|7.1|23.3|||Cochran-Mantel-Haenszel|||||23.3|7.1|0.0002
72510254|NCT02364947|144550941|SUPERIORITY_OR_OTHER_LEGACY|Cochran-Mantel-Haenszel test, stratified by sex and baseline value|Risk Difference (RD)|17.9||||0.0001|TWO_SIDED|95.0|8.9|26.9|||Cochran-Mantel-Haenszel|||||26.9|8.9|0.0001
72510255|NCT02364947|144550942|SUPERIORITY_OR_OTHER_LEGACY|Cochran-Mantel-Haenszel test, stratified by sex and baseline value|Risk Difference (RD)|8.0||||0.0724|TWO_SIDED|95.0|-0.7|16.7|||Cochran-Mantel-Haenszel|||||16.7|-0.7|0.0724
72510256|NCT02364947|144550942|SUPERIORITY_OR_OTHER_LEGACY|Cochran-Mantel-Haenszel test, stratified by sex and baseline value|Risk Difference (RD)|19.6||||0.0001|TWO_SIDED|95.0|9.9|29.2|||Cochran-Mantel-Haenszel|||||29.2|9.9|0.0001
72510257|NCT02364947|144550943|SUPERIORITY_OR_OTHER_LEGACY|Mixed model for repeated measures (MMRM) with fixed effect of treatment, sex, time point, treatment-by-time point interaction, baseline value, and baseline value-by-time point interaction with an unstructured variance-covariance matrix structure was used.|Mean Difference (Final Values)|-0.27|STANDARD_ERROR_OF_MEAN|0.07||0.0002|TWO_SIDED|95.0|-0.4|-0.13|||Mixed Models Analysis|||||-0.13|-0.40|0.0002
72401794|NCT02310919|144310935|NON_INFERIORITY|For the non-inferiority hypothesis testing of the primary outcome, a one-sided 95% CI was constructed for the relative risk. The alternative trigger will be considered non-inferior to the standard trigger if the lower bound of the one-sided CI of the relative risk is not less than 0.8 (i.e. risk reduction limit of 20%).|Risk Ratio (RR)|0.91|||||ONE_SIDED|95.0|0.83|||Using the standard trigger as the reference, the relative risk (i.e. risk ratio) (RR) with 95% confidence interval (CI) for the probability of the outcome was calculated using log-binomial regression models with application of GEE.|log-binomial regression with GEE||The numerator was the probability of the outcome with the alternative trigger, and the denominator was the probability of the outcome with the standard trigger.|The alternative trigger will be considered non-inferior to the standard hCG trigger if it is at least 80% as effective at inducing oocyte competence. Considering a cluster size of 15 oocytes and an estimated intra-cluster correlation of 0.1, we calculated that approximately 50 participants were needed in each study arm when the non-inferiority difference is -0.1 (i.e. 20% of 0.5 total competent proportion) with a power of 0.8 and a one-sided alpha of 0.05.|||0.83|
72401795|NCT02310919|144310936|SUPERIORITY||Risk Ratio (RR)|0.85||||0.06|TWO_SIDED|95.0|0.71|1.01||The statistical significance was based on a two-sided alpha of 0.05.|generalized linear model with log link|Comparison was done using generalized linear modeling with log link function|The numerator was the outcome with the alternative trigger, and the denominator was the outcome with the standard trigger.|The null hypothesis was that there would be no difference in number of oocytes retrieved between the patients triggered with low dose hCG plus FSH co-trigger and the standard hCG trigger.||1.01|0.71|0.06
72481351|NCT00051363|144489267|SUPERIORITY_OR_OTHER|||||||0.9518||||||2M E/F Function- SAT-D-NumRuCh (Mild OSA); P\<0.05 indicates statistical significance for P values. Outcome formulated as dichotomized variable (\<=2 vs. \>=3) based on a 5th percentile cut-off used in pilot studies per test developer suggestion.|Mixed Models Analysis|Generalized Linear Mixed Models (GLMM) were utilized to account for repeated measures (DX, 2M, 6M).||"Comparison of means (regression estimates) between arms for covariate adjusted 2M E/F Function- SAT-D-NumRuCh.~Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation \< 85% (PSG), age \< 60 years, WASI Verbal IQ, and WASI Performance IQ."||||0.9518
72481352|NCT00051363|144489267|SUPERIORITY_OR_OTHER|||||||0.4108||||||2M E/F Function- SAT-D-NumRuCh (Moderate OSA); P\<0.05 indicates statistical significance for P values. Outcome formulated as dichotomized variable (\<=2 vs. \>=3) based on a 5th percentile cut-off used in pilot studies per test developer suggestion.|Mixed Models Analysis|Generalized Linear Mixed Models (GLMM) were utilized to account for repeated measures (DX, 2M, 6M).||"Comparison of means (regression estimates) between arms for covariate adjusted 2M E/F Function- SAT-D-NumRuCh.~Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation \< 85% (PSG), age \< 60 years, WASI Verbal IQ, and WASI Performance IQ."||||0.4108
72510258|NCT02364947|144550943|SUPERIORITY_OR_OTHER_LEGACY|Mixed model for repeated measures (MMRM) with fixed effect of treatment, sex, time point, treatment-by-time point interaction, baseline value, and baseline value-by-time point interaction with an unstructured variance-covariance matrix structure was used.|Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.08||0.0001|TWO_SIDED|95.0|-0.45|-0.15|||Mixed Models Analysis|||||-0.15|-0.45|0.0001
72510259|NCT02364947|144550944|SUPERIORITY_OR_OTHER_LEGACY|Mixed model for repeated measures (MMRM) with fixed effect of treatment, sex, time point, treatment-by-time point interaction, baseline value, and baseline value-by-time point interaction with an unstructured variance-covariance matrix structure was used.|Mean Difference (Final Values)|-0.33|STANDARD_ERROR_OF_MEAN|0.08|<|0.0001|TWO_SIDED|95.0|-0.48|-0.18|||Mixed Models Analysis|||||-0.18|-0.48|<0.0001
72510260|NCT02364947|144550944|SUPERIORITY_OR_OTHER_LEGACY|Mixed model for repeated measures (MMRM) with fixed effect of treatment, sex, time point, treatment-by-time point interaction, baseline value, and baseline value-by-time point interaction with an unstructured variance-covariance matrix structure was used.|Mean Difference (Final Values)|-0.35|STANDARD_ERROR_OF_MEAN|0.08|<|0.0001|TWO_SIDED|95.0|-0.51|-0.19|||Mixed Models Analysis|||||-0.19|-0.51|<0.0001
72510261|NCT02364947|144550945|SUPERIORITY_OR_OTHER_LEGACY|Mixed model for repeated measures (MMRM) with fixed effect of treatment, sex, time point, treatment-by-time point interaction, baseline value, and baseline value-by-time point interaction with an unstructured variance-covariance matrix structure was used. Baseline CGI-S value was used as baseline value in MMRM.|Mean Difference (Final Values)|-0.51|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001|TWO_SIDED|95.0|-0.69|-0.33|||Mixed Models Analysis|||||-0.33|-0.69|<0.0001
72510262|NCT02364947|144550945|SUPERIORITY_OR_OTHER_LEGACY|Mixed model for repeated measures (MMRM) with fixed effect of treatment, sex, time point, treatment-by-time point interaction, baseline value, and baseline value-by-time point interaction with an unstructured variance-covariance matrix structure was used. Baseline CGI-S value was used as baseline value in MMRM.|Mean Difference (Final Values)|-0.47|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001|TWO_SIDED|95.0|-0.67|-0.27|||Mixed Models Analysis|||||-0.27|-0.67|<0.0001
72510263|NCT02364947|144550946|SUPERIORITY_OR_OTHER_LEGACY|Mixed model for repeated measures (MMRM) with fixed effect of treatment, sex, time point, treatment-by-time point interaction, baseline value, and baseline value-by-time point interaction with an unstructured variance-covariance matrix structure was used. Baseline CGI-S value was used as baseline value in MMRM.|Mean Difference (Final Values)|-0.51|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001|TWO_SIDED|95.0|-0.7|-0.31|||Mixed Models Analysis|||||-0.31|-0.70|<0.0001
72401796|NCT02310919|144310937|SUPERIORITY||Risk Ratio (RR)|0.87||||0.13|TWO_SIDED|95.0|0.72|1.04||The statistical significance was based on a two-sided alpha of 0.05.|generalized linear model with log link|Comparison was done using generalized linear modeling with log link function.|The numerator was the outcome with the alternative trigger, and the denominator was the outcome with the standard trigger.|The null hypothesis was that there would be no difference in the number of MII oocytes retrieved between the patients triggered with low dose hCG plus FSH co-trigger and the standard hCG trigger.||1.04|0.72|0.13
72401797|NCT02310919|144310938|SUPERIORITY||Risk Ratio (RR)|0.97||||0.47|TWO_SIDED|95.0|0.9|1.05||The statistical significance was based on a two-sided alpha of 0.05.|log-binomial regression with GEE||The numerator was the probability of the outcome with the alternative trigger, and the denominator was the probability of the outcome with the standard trigger.|The null hypothesis was that there would be no difference in oocyte maturity rate retrieved between the patients triggered with low dose hCG plus FSH co-trigger and the standard hCG trigger.||1.05|0.90|0.47
72481353|NCT00051363|144489267|SUPERIORITY_OR_OTHER|||||||0.4528||||||2M E/F Function- SAT-D-NumRuCh (Severe OSA); P\<0.05 indicates statistical significance for P values. Outcome formulated as dichotomized variable (\<=2 vs. \>=3) based on a 5th percentile cut-off used in pilot studies per test developer suggestion.|Mixed Models Analysis|Generalized Linear Mixed Models (GLMM) were utilized to account for repeated measures (DX, 2M, 6M).||"Comparison of means (regression estimates) between arms for covariate adjusted 2M E/F Function- SAT-D-NumRuCh.~Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation \< 85% (PSG), age \< 60 years, WASI Verbal IQ, and WASI Performance IQ."||||0.4528
72481354|NCT00051363|144489267|SUPERIORITY_OR_OTHER|||||||0.8391||||||6M E/F Function- SAT-D-NumRuCh (Mild OSA); P\<0.05 indicates statistical significance for P values. Outcome formulated as dichotomized variable (\<=2 vs. \>=3) based on a 5th percentile cut-off used in pilot studies per test developer suggestion.|Mixed Models Analysis|Generalized Linear Mixed Models (GLMM) were utilized to account for repeated measures (DX, 2M, 6M).||"Comparison of means (regression estimates) between arms for covariate adjusted 2M E/F Function- SAT-D-NumRuCh.~Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation \< 85% (PSG), age \< 60 years, WASI Verbal IQ, and WASI Performance IQ."||||0.8391
72481355|NCT00051363|144489267|SUPERIORITY_OR_OTHER|||||||0.2771||||||6M E/F Function- SAT-D-NumRuCh (Moderate OSA); P\<0.05 indicates statistical significance for P values. Outcome formulated as dichotomized variable (\<=2 vs. \>=3) based on a 5th percentile cut-off used in pilot studies per test developer suggestion.|Mixed Models Analysis|Generalized Linear Mixed Models (GLMM) were utilized to account for repeated measures (DX, 2M, 6M).||"Comparison of means (regression estimates) between arms for covariate adjusted 2M E/F Function- SAT-D-NumRuCh.~Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation \< 85% (PSG), age \< 60 years, WASI Verbal IQ, and WASI Performance IQ."||||0.2771
72481356|NCT00051363|144489267|SUPERIORITY_OR_OTHER|||||||0.8961||||||6M E/F Function- SAT-D-NumRuCh (Severe OSA); P\<0.05 indicates statistical significance for P values. Outcome formulated as dichotomized variable (\<=2 vs. \>=3) based on a 5th percentile cut-off used in pilot studies per test developer suggestion.|Mixed Models Analysis|Generalized Linear Mixed Models (GLMM) were utilized to account for repeated measures (DX, 2M, 6M).||"Comparison of means (regression estimates) between arms for covariate adjusted 2M E/F Function- SAT-D-NumRuCh.~Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation \< 85% (PSG), age \< 60 years, WASI Verbal IQ, and WASI Performance IQ."||||0.8961
72510264|NCT02364947|144550946|SUPERIORITY_OR_OTHER_LEGACY|Mixed model for repeated measures (MMRM) with fixed effect of treatment, sex, time point, treatment-by-time point interaction, baseline value, and baseline value-by-time point interaction with an unstructured variance-covariance matrix structure was used. Baseline CGI-S value was used as baseline value in MMRM.|Mean Difference (Final Values)|-0.55|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001|TWO_SIDED|95.0|-0.77|-0.33|||Mixed Models Analysis|||||-0.33|-0.77|<0.0001
72510265|NCT02364947|144550947|SUPERIORITY_OR_OTHER_LEGACY|Mixed model for repeated measures (MMRM) with fixed effect of treatment, sex, time point, treatment-by-time point interaction, logarithm scale baseline value, and logarithm scale baseline value-by-time point interaction with an unstructured variance-covariance matrix structure was used.|Mean Difference (Final Values)|-0.192|STANDARD_ERROR_OF_MEAN|0.036|<|0.0001|TWO_SIDED|95.0|-0.262|-0.121|||Mixed Models Analysis|||||-0.121|-0.262|<0.0001
72510266|NCT02364947|144550947|SUPERIORITY_OR_OTHER_LEGACY|Mixed model for repeated measures (MMRM) with fixed effect of treatment, sex, time point, treatment-by-time point interaction, logarithm scale baseline value, and logarithm scale baseline value-by-time point interaction with an unstructured variance-covariance matrix structure was used.|Mean Difference (Final Values)|-0.156|STANDARD_ERROR_OF_MEAN|0.039||0.0001|TWO_SIDED|95.0|-0.232|-0.08|||Mixed Models Analysis|||||-0.080|-0.232|0.0001
72510267|NCT02364947|144550948|SUPERIORITY_OR_OTHER_LEGACY|Mixed model for repeated measures (MMRM) with fixed effect of treatment, sex, time point, treatment-by-time point interaction, logarithm scale baseline value, and logarithm scale baseline value-by-time point interaction with an unstructured variance-covariance matrix structure was used.|Mean Difference (Final Values)|-0.168|STANDARD_ERROR_OF_MEAN|0.041|<|0.0001|TWO_SIDED|95.0|-0.248|-0.088|||Mixed Models Analysis|||||-0.088|-0.248|<0.0001
72510268|NCT02364947|144550948|SUPERIORITY_OR_OTHER_LEGACY|Mixed model for repeated measures (MMRM) with fixed effect of treatment, sex, time point, treatment-by-time point interaction, logarithm scale baseline value, and logarithm scale baseline value-by-time point interaction with an unstructured variance-covariance matrix structure was used.|Mean Difference (Final Values)|-0.139|STANDARD_ERROR_OF_MEAN|0.044||0.0017|TWO_SIDED|95.0|-0.226|-0.052|||Mixed Models Analysis|||||-0.052|-0.226|0.0017
72510269|NCT02364947|144550949|SUPERIORITY_OR_OTHER_LEGACY|Mixed model for repeated measures (MMRM) with fixed effect of treatment, sex, time point, treatment-by-time point interaction, logarithm scale baseline value, and logarithm scale baseline value-by-time point interaction with an unstructured variance-covariance matrix structure was used.|Mean Difference (Final Values)|-0.07|STANDARD_ERROR_OF_MEAN|0.031||0.0234|TWO_SIDED|95.0|-0.13|-0.009|||Mixed Models Analysis|||||-0.009|-0.130|0.0234
72401798|NCT02310919|144310939|SUPERIORITY||Risk Ratio (RR)|0.88||||0.01|TWO_SIDED|95.0|0.76|0.97||The statistical significance was based on a two-sided alpha of 0.05.|log-binomial regression with GEE||The numerator was the probability of the outcome with the alternative trigger, and the denominator was the probability of the outcome with the standard trigger.|||0.97|0.76|0.01
72481357|NCT00051363|144489268|SUPERIORITY_OR_OTHER|||||||0.654||||||DX- MWT-MSL; Comparison of means by visit only; P\<0.05 indicates statistical significance for P values.|Chop-lump Wilcoxon|Chop-lump test was selected due to a high frequency of scores at the twenty-minute ceiling.||Comparison of means (regression estimates) between arms for DX Objective Sleepiness/Alertness- MWT-MSL.||||0.6540
72481358|NCT00051363|144489268|SUPERIORITY_OR_OTHER|||||||0.9778||||||DX- MWT-MSL (Mild OSA); Comparison of means by visit and Obstructive Sleep Apnea (OSA) severity; P\<0.05 indicates statistical significance for P values.|Chop-lump Wilcoxon|Chop-lump test was selected due to a high frequency of scores at the twenty-minute ceiling.||Comparison of means (regression estimates) between arms for DX Objective Sleepiness/Alertness- MWT-MSL.||||0.9778
72481359|NCT00051363|144489268|SUPERIORITY_OR_OTHER|||||||0.8314||||||DX- MWT-MSL (Moderate OSA); Comparison of means by visit and Obstructive Sleep Apnea (OSA) severity; P\<0.05 indicates statistical significance for P values.|Chop-lump Wilcoxon|Chop-lump test was selected due to a high frequency of scores at the twenty-minute ceiling.||Comparison of means (regression estimates) between arms for DX Objective Sleepiness/Alertness- MWT-MSL.||||0.8314
72481360|NCT00051363|144489268|SUPERIORITY_OR_OTHER|||||||0.5018||||||DX- MWT-MSL (Severe OSA); Comparison of means by visit and Obstructive Sleep Apnea (OSA) severity; P\<0.05 indicates statistical significance for P values.|Chop-lump Wilcoxon|Chop-lump test was selected due to a high frequency of scores at the twenty-minute ceiling.||Comparison of means (regression estimates) between arms for DX Objective Sleepiness/Alertness- MWT-MSL.||||0.5018
72481361|NCT00051363|144489268|SUPERIORITY_OR_OTHER|||||||0.0052||||||2M- MWT-MSL; Comparison of means by visit only; P\<0.05 indicates statistical significance for P values.|Chop-lump Wilcoxon|Chop-lump test was selected due to a high frequency of scores at the twenty-minute ceiling.||Comparison of means (regression estimates) between arms for 2M Objective Sleepiness/Alertness- MWT-MSL.||||0.0052
72481362|NCT00051363|144489268|SUPERIORITY_OR_OTHER|||||||0.2476||||||2M- MWT-MSL (Mild OSA); Comparison of means by visit and Obstructive Sleep Apnea (OSA) severity; P\<0.05 indicates statistical significance for P values.|Chop-lump Wilcoxon|Chop-lump test was selected due to a high frequency of scores at the twenty-minute ceiling.||Comparison of means (regression estimates) between arms for 2M Objective Sleepiness/Alertness- MWT-MSL.||||0.2476
72481363|NCT00051363|144489268|SUPERIORITY_OR_OTHER|||||||0.752||||||2M- MWT-MSL (Moderate OSA); Comparison of means by visit and Obstructive Sleep Apnea (OSA) severity; P\<0.05 indicates statistical significance for P values.|Chop-lump Wilcoxon|Chop-lump test was selected due to a high frequency of scores at the twenty-minute ceiling.||Comparison of means (regression estimates) between arms for 2M Objective Sleepiness/Alertness- MWT-MSL.||||0.7520
72481364|NCT00051363|144489268|SUPERIORITY_OR_OTHER|||||||0.0002||||||2M- MWT-MSL (Severe OSA); Comparison of means by visit and Obstructive Sleep Apnea (OSA) severity; P\<0.05 indicates statistical significance for P values.|Chop-lump Wilcoxon|Chop-lump test was selected due to a high frequency of scores at the twenty-minute ceiling.||Comparison of means (regression estimates) between arms for 2M Objective Sleepiness/Alertness- MWT-MSL.||||0.0002
72481365|NCT00051363|144489268|SUPERIORITY_OR_OTHER|||||||0.0022||||||6M- MWT-MSL; Comparison of means by visit only; P\<0.05 indicates statistical significance for P values.|Chop-lump Wilcoxon|Chop-lump test was selected due to a high frequency of scores at the twenty-minute ceiling.||Comparison of means (regression estimates) between arms for 6M Objective Sleepiness/Alertness- MWT-MSL.||||0.0022
72481366|NCT00051363|144489268|SUPERIORITY_OR_OTHER|||||||0.763||||||6M- MWT-MSL (Mild OSA); Comparison of means by visit and Obstructive Sleep Apnea (OSA) severity; P\<0.05 indicates statistical significance for P values.|Chop-lump Wilcoxon|Chop-lump test was selected due to a high frequency of scores at the twenty-minute ceiling.||Comparison of means (regression estimates) between arms for 6M Objective Sleepiness/Alertness- MWT-MSL.||||0.7630
72481367|NCT00051363|144489268|SUPERIORITY_OR_OTHER|||||||0.517||||||6M- MWT-MSL (Moderate OSA); Comparison of means by visit and Obstructive Sleep Apnea (OSA) severity; P\<0.05 indicates statistical significance for P values.|Chop-lump Wilcoxon|Chop-lump test was selected due to a high frequency of scores at the twenty-minute ceiling.||Comparison of means (regression estimates) between arms for 6M Objective Sleepiness/Alertness- MWT-MSL.||||0.5170
72510270|NCT02364947|144550949|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.049|STANDARD_ERROR_OF_MEAN|0.033||0.1374|TWO_SIDED|95.0|-0.115|0.016|||Mixed Models Analysis|||Mixed model for repeated measures (MMRM) with fixed effect of treatment, sex, time point, treatment-by-time point interaction, logarithm scale baseline value, and logarithm scale baseline value-by-time point interaction with an unstructured variance-covariance matrix structure was used.||0.016|-0.115|0.1374
72481368|NCT00051363|144489268|SUPERIORITY_OR_OTHER|||||||0.0002||||||6M- MWT-MSL (Severe OSA); Comparison of means by visit and Obstructive Sleep Apnea (OSA) severity; P\<0.05 indicates statistical significance for P values.|Chop-lump Wilcoxon|Chop-lump test was selected due to a high frequency of scores at the twenty-minute ceiling.||Comparison of means (regression estimates) between arms for 6M Objective Sleepiness/Alertness- MWT-MSL.||||0.0002
72481369|NCT00051363|144489269|SUPERIORITY_OR_OTHER|||||||0.9291||||||DX- ESS-TS; Comparison of means by visit only; P\<0.05 indicates statistical significance for P values.|Regression, Linear|Regression analyses for the ESS used Generalized Linear Models (GLM) for an over-dispersed binomial distribution.||Comparison of means (regression estimates) between arms for DX Subjective Sleepiness/Alertness- ESS-TS.||||0.9291
72481370|NCT00051363|144489269|SUPERIORITY_OR_OTHER|||||||0.6152||||||DX- ESS-TS (Mild OSA); Comparison of means by visit and Obstructive Sleep Apnea (OSA) severity; P\<0.05 indicates statistical significance for P values.|Regression, Linear|Regression analyses for the ESS used Generalized Linear Models (GLM) for an over-dispersed binomial distribution.||Comparison of means (regression estimates) between arms for DX Subjective Sleepiness/Alertness- ESS-TS.||||0.6152
72481371|NCT00051363|144489269|SUPERIORITY_OR_OTHER|||||||0.704||||||DX- ESS-TS (Moderate OSA); Comparison of means by visit and Obstructive Sleep Apnea (OSA) severity; P\<0.05 indicates statistical significance for P values.|Regression, Linear|Regression analyses for the ESS used Generalized Linear Models (GLM) for an over-dispersed binomial distribution.||Comparison of means (regression estimates) between arms for DX Subjective Sleepiness/Alertness- ESS-TS.||||0.7040
72481372|NCT00051363|144489269|SUPERIORITY_OR_OTHER|||||||0.9537||||||DX- ESS-TS (Severe OSA); Comparison of means by visit and Obstructive Sleep Apnea (OSA) severity; P\<0.05 indicates statistical significance for P values.|Regression, Linear|Regression analyses for the ESS used Generalized Linear Models (GLM) for an over-dispersed binomial distribution.||Comparison of means (regression estimates) between arms for DX Subjective Sleepiness/Alertness- ESS-TS.||||0.9537
72481373|NCT00051363|144489269|SUPERIORITY_OR_OTHER|||||||0.0004||||||2M- ESS-TS; Comparison of means by visit only; P\<0.05 indicates statistical significance for P values.|Regression, Linear|Regression analyses for the ESS used Generalized Linear Models (GLM) for an over-dispersed binomial distribution.||Comparison of means (regression estimates) between arms for 2M Subjective Sleepiness/Alertness- ESS-TS.||||0.0004
72481374|NCT00051363|144489269|SUPERIORITY_OR_OTHER|||||||0.3886||||||2M- ESS-TS (Mild OSA); Comparison of means by visit and Obstructive Sleep Apnea (OSA) severity; P\<0.05 indicates statistical significance for P values.|Regression, Linear|Regression analyses for the ESS used Generalized Linear Models (GLM) for an over-dispersed binomial distribution.||Comparison of means (regression estimates) between arms for 2M Subjective Sleepiness/Alertness- ESS-TS.||||0.3886
72481375|NCT00051363|144489269|SUPERIORITY_OR_OTHER|||||||0.0236||||||2M- ESS-TS (Moderate OSA); Comparison of means by visit and Obstructive Sleep Apnea (OSA) severity; P\<0.05 indicates statistical significance for P values.|Regression, Linear|Regression analyses for the ESS used Generalized Linear Models (GLM) for an over-dispersed binomial distribution.||Comparison of means (regression estimates) between arms for 2M Subjective Sleepiness/Alertness- ESS-TS.||||0.0236
72481376|NCT00051363|144489269|SUPERIORITY_OR_OTHER|||||||0.0005||||||2M- ESS-TS (Severe OSA); Comparison of means by visit and Obstructive Sleep Apnea (OSA) severity; P\<0.05 indicates statistical significance for P values.|Regression, Linear|Regression analyses for the ESS used Generalized Linear Models (GLM) for an over-dispersed binomial distribution.||Comparison of means (regression estimates) between arms for 2M Subjective Sleepiness/Alertness- ESS-TS.||||0.0005
72481377|NCT00051363|144489269|SUPERIORITY_OR_OTHER|||||||0.0005||||||6M- ESS-TS; Comparison of means by visit only; P\<0.05 indicates statistical significance for P values.|Regression, Linear|Regression analyses for the ESS used Generalized Linear Models (GLM) for an over-dispersed binomial distribution.||Comparison of means (regression estimates) between arms for 6M Subjective Sleepiness/Alertness- ESS-TS.||||0.0005
72481378|NCT00051363|144489269|SUPERIORITY_OR_OTHER|||||||0.3796||||||6M- ESS-TS (Mild OSA); Comparison of means by visit and Obstructive Sleep Apnea (OSA) severity; P\<0.05 indicates statistical significance for P values.|Regression, Linear|Regression analyses for the ESS used Generalized Linear Models (GLM) for an over-dispersed binomial distribution.||Comparison of means (regression estimates) between arms for 6M Subjective Sleepiness/Alertness- ESS-TS.||||0.3796
72481379|NCT00051363|144489269|SUPERIORITY_OR_OTHER|||||||0.0106||||||6M- ESS-TS (Moderate OSA); Comparison of means by visit and Obstructive Sleep Apnea (OSA) severity; P\<0.05 indicates statistical significance for P values.|Regression, Linear|Regression analyses for the ESS used Generalized Linear Models (GLM) for an over-dispersed binomial distribution.||Comparison of means (regression estimates) between arms for 6M Subjective Sleepiness/Alertness- ESS-TS.||||0.0106
72481380|NCT00051363|144489269|SUPERIORITY_OR_OTHER|||||||0.001||||||6M- ESS-TS (Severe OSA); Comparison of means by visit and Obstructive Sleep Apnea (OSA) severity; P\<0.05 indicates statistical significance for P values.|Regression, Linear|Regression analyses for the ESS used Generalized Linear Models (GLM) for an over-dispersed binomial distribution.||Comparison of means (regression estimates) between arms for 6M Subjective Sleepiness/Alertness- ESS-TS.||||0.0010
72510271|NCT02364947|144550950|SUPERIORITY_OR_OTHER_LEGACY|Mixed model for repeated measures (MMRM) with fixed effect of treatment, sex, time point, treatment-by-time point interaction, logarithm scale baseline value, and logarithm scale baseline value-by-time point interaction with an unstructured variance-covariance matrix structure was used.|Mean Difference (Final Values)|-0.066|STANDARD_ERROR_OF_MEAN|0.031||0.0348|TWO_SIDED|95.0|-0.127|-0.005|||Mixed Models Analysis|||||-0.005|-0.127|0.0348
72510272|NCT02364947|144550950|SUPERIORITY_OR_OTHER_LEGACY|Mixed model for repeated measures (MMRM) with fixed effect of treatment, sex, time point, treatment-by-time point interaction, logarithm scale baseline value, and logarithm scale baseline value-by-time point interaction with an unstructured variance-covariance matrix structure was used.|Mean Difference (Final Values)|-0.049|STANDARD_ERROR_OF_MEAN|0.034||0.1444|TWO_SIDED|95.0|-0.116|0.017|||Mixed Models Analysis|||||0.017|-0.116|0.1444
72510273|NCT02163993|144550960|SUPERIORITY||Posterior Mean Difference|-0.57|STANDARD_DEVIATION|0.42|||TWO_SIDED|95.0|-1.4|0.24|||Bayesian Dose Response Model|||||0.24|-1.40|
72481381|NCT01323634|144489365|SUPERIORITY_OR_OTHER||Least square mean difference|0.08|||<|0.001|TWO_SIDED|95.0|0.037|0.124|||ANCOVA|||||0.124|0.037|<0.001
72481382|NCT02678247|144489370|SUPERIORITY||Mean Difference (Final Values)|1.5|STANDARD_DEVIATION|1.5|<|0.001|TWO_SIDED|95.0|0.8|2.3||alpha = 0.05|t-test, 2 sided|paired t-test||||2.3|0.8|<0.001
72481383|NCT02678247|144489371|SUPERIORITY||Mean Difference (Final Values)|-0.01|STANDARD_DEVIATION|0.1||0.664|TWO_SIDED|95.0|-0.06|0.04||p-value was adjusted using a Bonferonni correction with alpha set at 0.017|t-test, 2 sided|paired t-test||||0.04|-0.06|0.664
72481384|NCT02678247|144489372|SUPERIORITY||Mean Difference (Final Values)|-1.7|STANDARD_DEVIATION|3.05||0.026|TWO_SIDED|95.0|-3.17|-0.23||p-value was adjusted using a Bonferonni correction with alpha set at 0.017|t-test, 2 sided|paired t-test||||-0.23|-3.17|0.026
72481385|NCT02678247|144489373|SUPERIORITY||Mean Difference (Final Values)|0.21|STANDARD_DEVIATION|4.58||0.847|TWO_SIDED|95.0|-2.0|2.42||p-value was adjusted using a Bonferonni correction with alpha set at 0.025|t-test, 2 sided|paired t-test||||2.42|-2|0.847
72481386|NCT02678247|144489374|SUPERIORITY||Mean Difference (Final Values)|-1.04|STANDARD_DEVIATION|2.87|<|0.017|TWO_SIDED|95.0|-2.42|0.34||p-value was adjusted using a Bonferonni correction with alpha set at 0.017|t-test, 2 sided|paired t-test||||0.34|-2.42|<0.017
72481387|NCT02678247|144489375|OTHER||Mean Difference (Final Values)|0.12|STANDARD_DEVIATION|4.58||0.7|TWO_SIDED|95.0|-0.53|0.77||p-value was adjusted using a Bonferonni correction with alpha set at 0.025|t-test, 2 sided|paired t-test||||0.77|-0.53|0.7
72481388|NCT02678247|144489376|SUPERIORITY||Mean Difference (Final Values)|2.7|STANDARD_DEVIATION|8.9||0.2|TWO_SIDED|95.0|-1.6|7.0||alpha = 0.05|t-test, 2 sided|paired t-test||||7.0|-1.6|0.20
72510274|NCT02163993|144550960|SUPERIORITY||Posterior Mean Difference|-0.25|STANDARD_DEVIATION|0.41|||TWO_SIDED|95.0|-1.06|0.56|||Bayesian Dose Response Model|||||0.56|-1.06|
72510275|NCT02163993|144550960|SUPERIORITY||Posterior Mean Difference|-1.14|STANDARD_DEVIATION|0.44|||TWO_SIDED|95.0|-2.02|-0.29|||Bayesian Dose Response Model|||||-0.29|-2.02|
72481389|NCT02678247|144489377|SUPERIORITY||Mean Difference (Final Values)|-1.2|STANDARD_DEVIATION|10.0||0.62|TWO_SIDED|95.0|-6.0|3.7||alpha = 0.05|t-test, 2 sided|paired t-test||||3.7|-6.0|0.62
72481390|NCT02678247|144489378|SUPERIORITY||Mean Difference (Final Values)|2.6|STANDARD_DEVIATION|5.7||0.07|TWO_SIDED|95.0|-0.2|5.3||alpha = 0.05|t-test, 2 sided|paired t-test||||5.3|-0.2|0.07
72481391|NCT02678247|144489379|SUPERIORITY||Mean Difference (Final Values)|-2.1|STANDARD_DEVIATION|6.3||0.18|TWO_SIDED|95.0|-5.4|1.1||alpha = 0.05|t-test, 2 sided|paired t-test||||1.1|-5.4|0.18
72481392|NCT02678247|144489380|SUPERIORITY||Mean Difference (Final Values)|0.2|STANDARD_DEVIATION|1.3||0.47|TWO_SIDED|95.0|-0.4|0.9||alpha = 0.05|t-test, 2 sided|paired t-test||||0.9|-0.4|0.47
72481393|NCT02678247|144489381|SUPERIORITY||Mean Difference (Final Values)|0.3|STANDARD_DEVIATION|3.5||0.68|TWO_SIDED|95.0|-1.4|2.0||alpha = 0.05|t-test, 2 sided|paired t-test||||2.0|-1.4|0.68
72481394|NCT04223856|144489382|SUPERIORITY||Hazard Ratio (HR)|0.45|||<|1e-05|TWO_SIDED|95.0|0.377|0.538||P value was calculated using stratified log-rank test. The p-value threshold for statistical significance is 0.005.|Log Rank||HR was calculated using stratified Cox proportional hazards model.|||0.538|0.377|<0.00001
72481395|NCT04223856|144489383|SUPERIORITY|P value was calculated using stratified log-rank test. The p-value threshold for statistical significance is 0.01548.|Hazard Ratio (HR)|0.468|||<|1e-05|TWO_SIDED|95.0|0.376|0.582|||Log Rank||HR was calculated using stratified Cox proportional hazards model.|||0.582|0.376|<0.00001
72481396|NCT03226275|144489403|EQUIVALENCE|Results based on a mixed-effects model with sequence, treatment, and period as fixed effects and participant nested within sequence as a random effect.|Geometric Least Square Mean Percentage|99.46|||||TWO_SIDED|90.0|93.25|106.09||||||Statistical Comparison of Bisoprolol in Fasting state||106.09|93.25|
72481397|NCT03226275|144489403|EQUIVALENCE|Results based on a mixed-effects model with sequence, treatment, and period as fixed effects and participant nested within sequence as a random effect.|Geometric Least Square Mean Percentage|96.76|||||TWO_SIDED|90.0|92.95|100.73||||||Statistical Comparison of Amlodipine in Fasting State||100.73|92.95|
72481398|NCT03226275|144489403|EQUIVALENCE|Results based on a mixed-effects model with sequence, treatment, and period as fixed effects and participant nested within sequence as a random effect.|Geometric Least Square Mean Percentage|98.95|||||TWO_SIDED|90.0|90.02|108.76||||||Statistical Comparison of Bisoprolol in Fed State||108.76|90.02|
72481399|NCT03226275|144489403|EQUIVALENCE|Results based on a mixed-effects model with sequence, treatment, and period as fixed effects and participant nested within sequence as a random effect.|Geometric Least Square Mean Percentage|103.07|||||TWO_SIDED|90.0|95.53|111.2||||||Statistical Comparison of Amlodipine in Fed State||111.20|95.53|
72481400|NCT03226275|144489404|EQUIVALENCE|Results based on a mixed-effects model with sequence, treatment, and period as fixed effects and participant nested within sequence as a random effect.|Geometric Least Square Mean Percentage|97.85|||||TWO_SIDED|90.0|92.29|103.74||||||Statistical Comparison of Bisoprolol in Fasting State||103.74|92.29|
72481401|NCT03226275|144489404|EQUIVALENCE|Results based on a mixed-effects model with sequence, treatment, and period as fixed effects and participant nested within sequence as a random effect.|Geometric Least Square Mean Percentage|100.03|||||TWO_SIDED|90.0|94.37|106.03||||||Statistical Comparison of Amlodipine in Fasting State||106.03|94.37|
72481402|NCT03226275|144489404|EQUIVALENCE|Results based on a mixed-effects model with sequence, treatment, and period as fixed effects and participant nested within sequence as a random effect.|Geometric Least Square Mean Percentage|93.87|||||TWO_SIDED|90.0|84.56|104.2||||||Statistical Comparison of Bisoprolol in Fed State||104.20|84.56|
72481403|NCT03226275|144489404|EQUIVALENCE|Results based on a mixed-effects model with sequence, treatment, and period as fixed effects and participant nested within sequence as a random effect.|Geometric Least Square Mean Percentage|106.56|||||TWO_SIDED|90.0|97.82|116.08||||||Statistical Comparison of Amlodipine in Fed State||116.08|97.82|
72481404|NCT03226275|144489405|EQUIVALENCE|Results based on a mixed-effects model with sequence, treatment, and period as fixed effects and participant nested within sequence as a random effect.|Median Difference|0.13|||||TWO_SIDED|90.0|0.0|0.5||||||Statistical Comparison of Bisoprolol in Fasting State||0.50|0.00|
72481405|NCT03226275|144489405|EQUIVALENCE|Results based on a mixed-effects model with sequence, treatment, and period as fixed effects and participant nested within sequence as a random effect.|Median Difference|0.0|||||TWO_SIDED|90.0|-1.0|0.0||||||Statistical Comparison of Amlodipine in Fasting State||0.00|-1.00|
72481406|NCT03226275|144489405|EQUIVALENCE|Results based on a mixed-effects model with sequence, treatment, and period as fixed effects and participant nested within sequence as a random effect.|Median Difference|0.0|||||TWO_SIDED|90.0|-1.0|0.5||||||Statistical Comparison of Bisoprolol in Fed State||0.50|-1.00|
72481407|NCT03226275|144489405|EQUIVALENCE|Results based on a mixed-effects model with sequence, treatment, and period as fixed effects and participant nested within sequence as a random effect.|Median Difference|0.0|||||TWO_SIDED|90.0|-1.0|0.5||||||Statistical Comparison of Amlodipine in Fed State||0.50|-1.00|
72481408|NCT03226275|144489407|EQUIVALENCE|Results based on a mixed-effects model with sequence, treatment, and period as fixed effects and participant nested within sequence as a random effect.|Geometric Least Square Mean Percentage|99.98|||||TWO_SIDED|90.0|93.61|106.79||||||Statistical Comparison of Bisoprolol in Fasting State||106.79|93.61|
72481409|NCT03226275|144489407|EQUIVALENCE|Results based on a mixed-effects model with sequence, treatment, and period as fixed effects and participant nested within sequence as a random effect.|Geometric Least Square Mean Percentage|98.68|||||TWO_SIDED|90.0|93.38|104.28||||||Statistical Comparison of Amlodipine in Fasting State||104.28|93.38|
72481410|NCT03226275|144489407|EQUIVALENCE|Results based on a mixed-effects model with sequence, treatment, and period as fixed effects and participant nested within sequence as a random effect.|Geometric Least Square Mean Percentage|98.52|||||TWO_SIDED|90.0|89.75|108.15||||||Statistical Comparison of Bisoprolol in Fed State||108.15|89.75|
72481411|NCT03226275|144489407|EQUIVALENCE|Results based on a mixed-effects model with sequence, treatment, and period as fixed effects and participant nested within sequence as a random effect.|Geometric Least Square Mean Percentage|104.06|||||TWO_SIDED|90.0|96.11|112.66||||||Statistical Comparison of Amlodipine in Fed State||112.66|96.11|
72481412|NCT02245672|144489437|SUPERIORITY|In order for the bioequivalence results to be valid, assay sensitivity had to be established. For assay sensitivity, the following comparisons were performed using the Full Analysis Set for each co-primary endpoint: MGR001 versus placebo, and Advair Diskus versus placebo. Assay sensitivity was demonstrated if the p-values for active treatment versus placebo were less than 0.05|||||<|0.0001|||||||ANCOVA|||MGR001 (Test) vs Placebo||||<0.0001
72481413|NCT02245672|144489437|SUPERIORITY|In order for the bioequivalence results to be valid, assay sensitivity had to be established.For assay sensitivity, the following comparisons were performed using the Full Analysis Set for each co-primary endpoint: MGR001 versus placebo, and Advair Diskus versus placebo. Assay sensitivity was demonstrated if the p-values for active treatment versus placebo were less than 0.05|||||<|0.0001|||||||ANCOVA|||Advair Diskus (Reference) vs Placebo||||<0.0001
72481414|NCT02245672|144489438|EQUIVALENCE|A linear analysis of covariance (ANCOVA) model was fitted for the endpoint and least-squares (LS) means were derived for each treatment. To assess equivalence, LS means (one for Test and one for Reference) from the ANCOVA models were used to generate Test/Reference ratios and 90% CIs were calculated by using Fieller's theorem. To demonstrate equivalence, the 90% CIs were each required to be wholly contained within the interval 0.80-1.25 (i.e., 80%-125%).|Ratio (MGR001/Advair Diskus)|1.12|||||TWO_SIDED|90.0|1.016|1.237|||||Bioequivalence was established between active treatments (MGR001 and Advair Diskus) for the FEV1 AUEC0-12 clinical endpoint|Equivalence of MGR001 and Advair Diskus is established if the ratio of the LS means and 90% confidence interval are wholly contained within the interval 0.80-1.25 (i.e., 80%-125%).||1.237|1.016|
72481415|NCT02245672|144489439|SUPERIORITY|In order for the bioequivalence results to be valid, assay sensitivity had to be established. For assay sensitivity, the following comparisons were performed using the Full Analysis Set for each co-primary endpoint: MGR001 versus placebo, and Advair Diskus versus placebo. Assay sensitivity was demonstrated if the p-values for active treatment versus placebo were less than 0.05|||||<|0.0001|||||||ANCOVA|||MGR001 (Test) vs Placebo||||<0.0001
72481416|NCT02245672|144489439|SUPERIORITY|In order for the bioequivalence results to be valid, assay sensitivity had to be established. For assay sensitivity, the following comparisons were performed using the Full Analysis Set for each co-primary endpoint: MGR001 versus placebo, and Advair Diskus versus placebo. Assay sensitivity was demonstrated if the p-values for active treatment versus placebo were less than 0.05|||||<|0.0001|||||||ANCOVA|||Advair Diskus (Reference) vs Placebo||||<0.0001
72481417|NCT02245672|144489440|EQUIVALENCE|A linear analysis of covariance (ANCOVA) model was fitted for the endpoint and least-squares (LS) means were derived for each treatment. To assess equivalence, LS means (one for Test and one for Reference) from the ANCOVA models were used to generate Test/Reference ratios and 90% CIs were calculated by using Fieller's theorem. To demonstrate equivalence, the 90% CIs were each required to be wholly contained within the interval 0.80-1.25 (i.e., 80%-125%).|Ratio (MGR001/Advair Diskus)|1.069|||||TWO_SIDED|90.0|0.938|1.22|||||Bioequivalence was established between active treatments (MGR001 and Advair Diskus) for change from baseline in trough FEV1 endpoint on Day 29|Equivalence of MGR001 and Advair Diskus is established if the ratio of the LS means and 90% confidence interval are wholly contained within the interval 0.80-1.25 (i.e., 80%-125%).||1.220|0.938|
72481418|NCT01097785|144489448|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Student's t-test|||||||<0.05
72481419|NCT01097785|144489449|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Student's t-test|||||||<0.05
72481420|NCT01765192|144489450|SUPERIORITY_OR_OTHER||Least Squares (LS) Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.039||0.013|TWO_SIDED|95.0|0.0219|0.1795|||ANCOVA|||The primary endpoint was analyzed using an analysis of covariance model adapted for the crossover design. The following fixed factors and covariates were included in the model: Treatment, sequence, period, and baseline FEV1 measurement of the respective treatment period. The reported analysis results are for the 2 crossover treatment periods combined.||0.1795|0.0219|0.013
72481421|NCT01765192|144489451|SUPERIORITY_OR_OTHER||LS Mean Difference|0.06|STANDARD_ERROR_OF_MEAN|0.04||0.129|TWO_SIDED|95.0|-0.0185|0.1422||P-values were obtained using an ANCOVA model with treatment sequence, treatment period, and study treatment as fixed factors with Baseline pre-bronchodilator FVC measurement as the covariate.|ANCOVA|||||0.1422|-0.0185|0.129
72510276|NCT02163993|144550960|SUPERIORITY||Posterior Mean Difference|-0.62|STANDARD_DEVIATION|0.45|||TWO_SIDED|95.0|-1.5|0.27|||Bayesian Dose Response Model|||||0.27|-1.50|
72510277|NCT02808312|144550988|OTHER|Two-sided 90% Confidence Intervals (CIs) were calculated for the ratios of geometric least-squares means (GLSMs) of PK parameters between mild hepatic impairment group and the control (normal hepatic function) group.|GLSM ratio|1.7869|||||TWO_SIDED|90.0|1.2885|2.4781||||||An analysis of variance (ANOVA) model with hepatic function group as a fixed effect was fitted to the natural logarithmic transformation of PK parameters (AUClast) for each cohort.||2.4781|1.2885|
72510278|NCT02808312|144550988|OTHER|Two-sided 90% CIs were calculated for the ratios of GLSMs of PK parameters between moderate hepatic impairment group and the control (normal hepatic function) group.|GLSM ratio|2.4868|||||TWO_SIDED|90.0|1.6735|3.6954||||||An ANOVA model with hepatic function group as a fixed effect was fitted to the natural logarithmic transformation of PK parameters (AUClast) for each cohort.||3.6954|1.6735|
72481422|NCT01765192|144489452|SUPERIORITY_OR_OTHER||LS Mean Difference|0.12|STANDARD_ERROR_OF_MEAN|0.056||0.032|TWO_SIDED|95.0|0.0113|0.2364||P-values were obtained using an ANCOVA model with treatment sequence, treatment period, and study treatment as fixed factors with Baseline pre-bronchodilator FEF measurement as the covariate.|ANCOVA|||||0.2364|0.0113|0.032
72481423|NCT01765192|144489453|SUPERIORITY_OR_OTHER||LS Mean Difference|7.21|STANDARD_ERROR_OF_MEAN|15.105||0.635||95.0|-23.0531|37.466||P-values were obtained using an ANCOVA model with treatment sequence, treatment period, and study treatment as fixed factors with Baseline pre-bronchodilator PEF measurement as the covariate.|ANCOVA|||||37.4660|-23.0531|0.635
72481424|NCT01765192|144489454|SUPERIORITY_OR_OTHER||LS Mean Difference|13.62|STANDARD_ERROR_OF_MEAN|5.206||0.011|TWO_SIDED|95.0|3.1896|24.0553||P-values were obtained using an ANCOVA model with treatment sequence, treatment period, and study treatment as fixed factors with Baseline pre-bronchodilator PEF measurement as the covariate.|ANCOVA|||||24.0553|3.1896|0.011
72510279|NCT02808312|144550988|OTHER|Two-sided 90% CIs were calculated for the ratios of GLSMs of PK parameters between severe hepatic impairment group and the control (normal hepatic function) group.|GLSM ratio|6.324|||||TWO_SIDED|90.0|4.3675|9.1569||||||An ANOVA model with hepatic function group as a fixed effect was fitted to the natural logarithmic transformation of PK parameters (AUClast) for each cohort.||9.1569|4.3675|
72510280|NCT02808312|144550989|OTHER|Two-sided 90% CIs were calculated for the ratios of GLSMs of PK parameters between mild hepatic impairment group and the control (normal hepatic function) group.|GLSM ratio|1.7628|||||TWO_SIDED|90.0|1.275|2.4374||||||An ANOVA model with hepatic function group as a fixed effect was fitted to the natural logarithmic transformation of PK parameters (AUCinf) for each cohort.||2.4374|1.2750|
72401799|NCT02310919|144310940|SUPERIORITY||Risk Ratio (RR)|1.0||||0.95|TWO_SIDED|95.0|0.9|1.1||The statistical significance was based on a two-sided alpha of 0.05.|log-binomial regression with GEE||The numerator was the probability of the outcome with the alternative trigger, and the denominator was the probability of the outcome with the standard trigger.|The null hypothesis was that there would be no difference in ICSI fertilization rate retrieved between the patients triggered with low dose hCG plus FSH co-trigger and the standard hCG trigger.||1.10|0.90|0.95
72401800|NCT02310919|144310941|SUPERIORITY||Risk Ratio (RR)|0.95||||0.52|TWO_SIDED|95.0|0.81|1.12||The statistical significance was based on a two-sided alpha of 0.05.|log-binomial regression with GEE||The numerator was the probability of the outcome with the alternative trigger, and the denominator was the probability of the outcome with the standard trigger.|The null hypothesis was that there would be no difference in the percentage of high quality cleavage-stage embryos between the patients triggered with low dose hCG plus FSH co-trigger and the standard hCG trigger.||1.12|0.81|0.52
72401801|NCT02310919|144310942|SUPERIORITY||Risk Ratio (RR)|0.99||||0.87|TWO_SIDED|95.0|0.84|1.16||The statistical significance was based on a two-sided alpha of 0.05.|log-binomial regression with GEE||The numerator was the probability of the outcome with the alternative trigger, and the denominator was the probability of the outcome with the standard trigger.|||1.16|0.84|0.87
72401802|NCT02310919|144310943|SUPERIORITY||Risk Ratio (RR)|1.01||||1|TWO_SIDED|95.0|0.59|1.74||The statistical significance was based on a two-sided alpha of 0.05.|Fisher Exact||The numerator was the probability of the outcome with the alternative trigger, and the denominator was the probability of the outcome with the standard trigger.|The null hypothesis was that there would be no difference in livebirths in fresh transfers between the patients triggered with low dose hCG plus FSH co-trigger and the standard hCG trigger.||1.74|0.59|1.0
72401803|NCT02310919|144310944|SUPERIORITY|||||||0.98|||||||Wilcoxon (Mann-Whitney)|||The null hypothesis was that there would be no difference in the change in bloating scores from day of baseline ultrasound to post-trigger day 5 between the patients triggered with low dose hCG plus FSH co-trigger and the standard hCG trigger.||||0.98
72401804|NCT02310919|144310945|SUPERIORITY|||||||0.39|||||||Wilcoxon (Mann-Whitney)|||The null hypothesis was that there would be no difference in the change in abdominal circumference from day of baseline ultrasound to post-trigger day 5 between the patients triggered with low dose hCG plus FSH co-trigger and the standard hCG trigger.||||0.39
72481425|NCT01765192|144489455|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.21|STANDARD_ERROR_OF_MEAN|0.089||0.025|TWO_SIDED|95.0|-0.385|-0.0271||P-values were obtained using an ANCOVA model with treatment sequence, treatment period, and study treatment as fixed factors with Baseline Daytime Asthma Symptom Score as the covariate.|ANCOVA|||||-0.0271|-0.3850|0.025
72566811|NCT02312713|144664438|NON_INFERIORITY|Since there were not sufficient data in prior literature to specific an a priori non-inferiority margin, for this and other secondary outcomes we based conclusions and discussions on magnitude of differences between the group, descriptively. This strategy was specified in the protocol.|Mean Difference (Final Values)|0.0||||1|TWO_SIDED|95.0|-0.78|0.77|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Internet Based Exercise Training at 12 months for Unilateral Stand Time.||0.77|-0.78|1.00
72401805|NCT02310919|144310946|SUPERIORITY|||||||0.41|||||||Wilcoxon (Mann-Whitney)|||The null hypothesis was that there would be no difference in the change in body weight from day of baseline ultrasound to post-trigger day 5 between the patients triggered with low dose hCG plus FSH co-trigger and the standard hCG trigger.||||0.41
72481426|NCT01765192|144489456|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.075||0.217|TWO_SIDED|95.0|-0.2426|0.0563||P-values were obtained using an ANCOVA model with treatment sequence, treatment period, and study treatment as fixed factors with Baseline Nighttime Asthma Symptoms measurement as the covariate.|ANCOVA|||||0.0563|-0.2426|0.217
72481427|NCT01535014|144489468|SUPERIORITY|||||||0.04|||||||Chi-squared|||||||0.04
72401806|NCT02310919|144310947|SUPERIORITY||||||<|0.001||||||The statistical significance was based on a two-sided alpha of 0.05.|Wilcoxon (Mann-Whitney)|||||||<0.001
72401807|NCT02310919|144310948|SUPERIORITY||||||<|0.001||||||The statistical significance was based on a two-sided alpha of 0.05.|Wilcoxon (Mann-Whitney)|||||||<0.001
72481428|NCT01535014|144489468|SUPERIORITY|||||||0.004|||||||Chi-squared|||||||0.004
72481429|NCT01535014|144489468|SUPERIORITY|||||||0.0007|||||||Cochran-Mantel-Haenszel|||||||0.0007
72566812|NCT02312713|144664439|SUPERIORITY||Mean Difference (Final Values)|-0.31||||0.63|TWO_SIDED|95.0|-1.55|0.94|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Wait List Control at 4 months for 30 Second Chair Stand.||.94|-1.55|0.63
72401808|NCT02310919|144310949|SUPERIORITY|||||||0.08||||||The statistical significance was based on a two-sided alpha of 0.05.|Wilcoxon (Mann-Whitney)|||||||0.08
72401809|NCT02310919|144310950|SUPERIORITY||||||<|0.001||||||The statistical significance was based on a two-sided alpha of 0.05.|Wilcoxon (Mann-Whitney)|||||||<0.001
72481430|NCT01535014|144489469|SUPERIORITY|||||||0.03|||||||t-test, 2 sided|||||||0.03
72481431|NCT01535014|144489469|SUPERIORITY|||||||0.07|||||||t-test, 2 sided|||||||0.07
72481432|NCT01535014|144489470|SUPERIORITY|||||||0.03|||||||t-test, 2 sided|||||||0.03
72481433|NCT01535014|144489470|SUPERIORITY|||||||0.07|||||||t-test, 2 sided|||||||0.07
72481434|NCT01535014|144489471|SUPERIORITY||||||<|0.05||||||For week 12, 16, 20, 24|Chi-squared|||||||<0.05
72481435|NCT01535014|144489471|SUPERIORITY||||||<|0.05||||||For week 16, 20, 24|Chi-squared|||||||<0.05
72481436|NCT01535014|144489472|SUPERIORITY|||||||0.019|||||||ANCOVA|||||||0.019
72481437|NCT01535014|144489472|SUPERIORITY|||||||0.043|||||||ANCOVA|||||||0.043
72481438|NCT01535014|144489473|SUPERIORITY|||||||0.2|||||||ANCOVA|||||||0.20
72481439|NCT01535014|144489473|SUPERIORITY|||||||0.75|||||||ANCOVA|||||||0.75
72481440|NCT01535014|144489474|SUPERIORITY|||||||0.02|||||||ANCOVA|||SF-36 Mental Health Domain||||0.02
72401810|NCT02310919|144310951|SUPERIORITY|||||||0.67||||||The statistical significance was based on a two-sided alpha of 0.05.|Wilcoxon (Mann-Whitney)|||||||0.67
72401811|NCT02310919|144310952|SUPERIORITY||||||<|0.001||||||The statistical significance was based on a two-sided alpha of 0.05.|Wilcoxon (Mann-Whitney)|||||||<0.001
72401812|NCT02310919|144310953|SUPERIORITY||||||<|0.001||||||The statistical significance was based on a two-sided alpha of 0.05.|Wilcoxon (Mann-Whitney)|||||||<0.001
72566813|NCT02312713|144664439|SUPERIORITY||Mean Difference (Final Values)|-0.49||||0.37|TWO_SIDED|95.0|-1.58|0.6|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Wait List Control at 12 months for 30 Second Chair Stand.||0.6|-1.58|0.37
72566814|NCT02312713|144664439|SUPERIORITY||Mean Difference (Final Values)|0.32||||0.62|TWO_SIDED|95.0|-0.95|1.59|||Mixed Models Analysis|||This is the comparison between Internet Based Exercise Training and Wait List Control at 4 months for 30 Second Chair Stand.||1.59|-0.95|0.62
72481441|NCT01535014|144489474|SUPERIORITY|||||||0.63|||||||ANCOVA|||SF-36 Mental Health Domain||||0.63
72481442|NCT01535014|144489474|SUPERIORITY|||||||0.6|||||||ANCOVA|||SF-36 Physical Health Domain||||0.60
72481443|NCT01535014|144489474|SUPERIORITY|||||||0.98|||||||ANCOVA|||SF-36 Physical Health Domain||||0.98
72481444|NCT01215422|144489475|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.0|||>|0.05|ONE_SIDED|95.0|0.15||||Regression, Logistic||||||0.15|>0.05
72481445|NCT01215422|144489476|SUPERIORITY_OR_OTHER|||||||0.03||95.0||||The p-value represents the comparison of the two interventions combined and compared against baseline for Grades III and IV summed together.|Fisher Exact|||||||0.03
72481446|NCT01215422|144489479|SUPERIORITY_OR_OTHER||R-squared|0.16|||>|0.05||95.0||||Correlation between years of experience (all anesthesiologists, pooled) and time to intubation (both GS and KS VLSs, pooled)|Correlation|||||||>0.05
72401813|NCT02310919|144310954|SUPERIORITY|||||||0.49||||||The statistical significance was based on a two-sided alpha of 0.05.|Wilcoxon (Mann-Whitney)|||||||0.49
72481447|NCT02864381|144489487|SUPERIORITY||Odds Ratio (OR)|1.5||||0.8|TWO_SIDED|95.0|0.4|6.1||P-value is derived from Cochran-Mantel Haenszel (CMH) test stratified by programmed death ligand 1 (PD-L1) stratification factor status.|Cochran-Mantel-Haenszel||Odds Ratio is derived from CMH test stratified by PD-L1 stratification factor status, the Nivolumab alone arm serves as the reference.|||6.1|0.4|0.8
72481448|NCT02864381|144489488|SUPERIORITY||Hazard Ratio (HR)|0.836||||0.306|TWO_SIDED|95.0|0.589|1.189||P-value is derived from log-rank test stratified by PD-L1 stratification factor status.|Log Rank||Hazard ratio is derived from Cox model stratified by PD-L1 stratification factor status, the Nivolumab alone arm serves as the reference.|||1.189|0.589|0.306
72481449|NCT02864381|144489489|SUPERIORITY||Hazard Ratio (HR)|0.786||||0.312|TWO_SIDED|95.0|0.491|1.257||P-value is derived from log-rank test stratified by PD-L1 stratification factor status.|Log Rank||Hazard ratio is derived from Cox model stratified by PD-L1 stratification factor status, the Nivolumab alone arm serves as the reference.|||1.257|0.491|0.312
72481450|NCT02113241|144489513|SUPERIORITY||||||<|0.001||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Analysis between before and after the intervention||||<0.001
72481451|NCT02113241|144489513|SUPERIORITY|||||||0.089||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Analysis between before and after the intervention||||0.089
72481452|NCT02113241|144489514|SUPERIORITY|||||||0.003||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Analysis between before and after the intervention||||0.003
72401814|NCT02310919|144310955|SUPERIORITY||||||<|0.001||||||The statistical significance was based on a two-sided alpha of 0.05.|Wilcoxon (Mann-Whitney)|||||||<0.001
72401815|NCT02310919|144310956|SUPERIORITY||||||<|0.001||||||The statistical significance was based on a two-sided alpha of 0.05.|Wilcoxon (Mann-Whitney)|||||||<0.001
72401816|NCT02310919|144310957|SUPERIORITY||||||<|0.001||||||The statistical significance was based on a two-sided alpha of 0.05.|Wilcoxon (Mann-Whitney)|||||||<0.001
72401817|NCT02310919|144310958|SUPERIORITY|||||||0.16||||||The statistical significance was based on a two-sided alpha of 0.05.|Wilcoxon (Mann-Whitney)|||||||0.16
72401818|NCT02310919|144310959|SUPERIORITY||||||<|0.001||||||The statistical significance was based on a two-sided alpha of 0.05.|Wilcoxon (Mann-Whitney)|||||||<0.001
72401819|NCT02310919|144310960|SUPERIORITY||||||<|0.001||||||The statistical significance was based on a two-sided alpha of 0.05.|Wilcoxon (Mann-Whitney)|||||||<0.001
72401820|NCT02310919|144310961|SUPERIORITY|||||||0.95||||||The statistical significance was based on a two-sided alpha of 0.05.|Wilcoxon (Mann-Whitney)|||||||0.95
72401821|NCT02310919|144310962|SUPERIORITY|||||||0.07||||||The statistical significance was based on a two-sided alpha of 0.05.|Wilcoxon (Mann-Whitney)|||||||0.07
72481453|NCT02113241|144489514|SUPERIORITY|||||||0.248||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Analysis between before and after the intervention||||0.248
72481454|NCT02113241|144489515|SUPERIORITY|||||||0.161||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Analysis between before and after the intervention||||0.161
72481455|NCT02113241|144489515|SUPERIORITY|||||||0.079||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Analysis between before and after the intervention||||0.079
72481456|NCT02113241|144489516|SUPERIORITY|||||||0.067||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Analysis between before and after the intervention||||0.067
72481457|NCT02113241|144489516|SUPERIORITY|||||||0.918||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Analysis between before and after the intervention||||0.918
72481458|NCT02113241|144489517|SUPERIORITY|||||||0.128||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Analysis between before and after the intervention||||0.128
72481459|NCT02113241|144489517|SUPERIORITY|||||||0.454||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Analysis between before and after the intervention||||0.454
72566815|NCT02312713|144664439|SUPERIORITY||Mean Difference (Final Values)|0.24||||0.67|TWO_SIDED|95.0|-0.87|1.35|||Mixed Models Analysis|||This is the comparison between Internet Based Exercise Training and Wait List Control at 12 months for 30 Second Chair Stand.||1.35|-0.87|0.67
72566816|NCT02312713|144664439|NON_INFERIORITY|Since there were not sufficient data in prior literature to specific an a priori non-inferiority margin, for this and other secondary outcomes we based conclusions and discussions on magnitude of differences between the group, descriptively. This strategy was specified in the protocol.|Mean Difference (Final Values)|0.63||||0.23|TWO_SIDED|95.0|-0.4|1.66|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Internet Based Exercise Training at 4 months for 30 Second Chair Stand.||1.66|-0.40|0.23
72401822|NCT02310919|144310963|SUPERIORITY|||||||0.66||||||The statistical significance was based on a two-sided alpha of 0.05.|Wilcoxon (Mann-Whitney)|||||||0.66
72481460|NCT02113241|144489518|SUPERIORITY|||||||0.433|||||||Wilcoxon (Mann-Whitney)|||Analysis between before and after the intervention||||0.433
72481461|NCT02113241|144489518|SUPERIORITY|||||||0.407||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Analysis between before and after the intervention||||0.407
72481462|NCT02113241|144489519|SUPERIORITY||||||<|0.001||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Analysis between before and after the intervention||||<0.001
72481463|NCT02113241|144489519|SUPERIORITY|||||||0.826||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Analysis between before and after the intervention||||0.826
72481464|NCT02113241|144489520|SUPERIORITY|||||||0.791||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Analysis between before and after the intervention||||0.791
72481465|NCT02113241|144489520|SUPERIORITY|||||||0.413||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Analysis between before and after the intervention||||0.413
72481466|NCT02113241|144489521|SUPERIORITY|||||||0.075||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Analysis between before and after the intervention||||0.075
72481467|NCT02113241|144489521|SUPERIORITY|||||||0.432||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Analysis between before and after the intervention||||0.432
72481468|NCT02113241|144489522|SUPERIORITY||||||<|0.001||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Analysis between before and after the intervention||||<0.001
72481469|NCT02113241|144489522|SUPERIORITY|||||||0.835||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Analysis between before and after the intervention||||0.835
72481470|NCT02113241|144489523|SUPERIORITY||||||<|0.001||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Analysis between before and after the intervention||||<0.001
72481471|NCT02113241|144489523|SUPERIORITY|||||||0.778||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Analysis between before and after the intervention||||0.778
72481472|NCT02113241|144489524|SUPERIORITY|||||||0.338||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Analysis between before and after the intervention||||0.338
72481473|NCT02113241|144489524|SUPERIORITY|||||||0.309||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Analysis between before and after the intervention||||0.309
72481474|NCT02113241|144489525|SUPERIORITY|||||||0.049||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Analysis between before and after the intervention||||0.049
72566817|NCT02312713|144664439|NON_INFERIORITY|Since there were not sufficient data in prior literature to specific an a priori non-inferiority margin, for this and other secondary outcomes we based conclusions and discussions on magnitude of differences between the group, descriptively. This strategy was specified in the protocol.|Mean Difference (Final Values)|0.74||||0.11|TWO_SIDED|95.0|-0.17|1.64|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Internet Based Exercise Training at 12 months for 30 Second Chair Stand.||1.64|-0.17|0.11
72481475|NCT02113241|144489525|SUPERIORITY|||||||0.563||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Analysis between before and after the intervention||||0.563
72481476|NCT02113241|144489526|SUPERIORITY|||||||0.85||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Analysis between before and after the intervention||||0.850
72481477|NCT02113241|144489526|SUPERIORITY|||||||0.206||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Analysis between before and after the intervention||||0.206
72401823|NCT02436759|144310964|SUPERIORITY||||||<|0.0001|||||||ANCOVA|Two-sided t-test with treatment as a fixed factor and baseline score as a covariate||||||<0.0001
72401824|NCT02436759|144310965|SUPERIORITY|||||||0.12|||||||ANCOVA|Two-sided t-test||||||0.12
72401825|NCT03616912|144310982|SUPERIORITY||Odds Ratio (OR)|1.57||||0.016|TWO_SIDED|95.0|1.09|2.27|||Regression, Logistic|||||2.27|1.09|0.016
72401826|NCT03616912|144310983|SUPERIORITY||Odds Ratio (OR)|1.14||||0.47|TWO_SIDED|95.0|0.79|1.65|||Regression, Logistic|||||1.65|0.79|0.470
72481478|NCT02113241|144489527|SUPERIORITY|||||||0.006||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Analysis between before and after the intervention||||0.006
72481479|NCT02113241|144489527|SUPERIORITY|||||||0.95||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Analysis between before and after the intervention||||0.950
72481480|NCT02113241|144489528|SUPERIORITY|||||||0.011||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Analysis between before and after the intervention||||0.011
72481481|NCT02113241|144489528|SUPERIORITY|||||||0.454||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Analysis between before and after the intervention||||0.454
72481482|NCT02113241|144489529|SUPERIORITY|||||||0.652||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Analysis between before and after the intervention||||0.652
72481483|NCT02113241|144489529|SUPERIORITY|||||||0.055||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Analysis between before and after the intervention||||0.055
72481484|NCT02113241|144489530|SUPERIORITY|||||||0.254||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Analysis between before and after the intervention||||0.254
72566818|NCT02312713|144664440|SUPERIORITY||Mean Difference (Final Values)|-0.39||||0.52|TWO_SIDED|95.0|-1.58|0.8|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Wait List Control at 4 months for Timed Up and Go.||0.8|-1.58|0.52
72510281|NCT02808312|144550989|OTHER|Two-sided 90% CIs were calculated for the ratios of GLSMs of PK parameters between moderate hepatic impairment group and the control (normal hepatic function) group.|GLSM ratio|2.4559|||||TWO_SIDED|90.0|1.6531|3.6486||||||An ANOVA model with hepatic function group as a fixed effect was fitted to the natural logarithmic transformation of PK parameters (AUCinf) for each cohort.||3.6486|1.6531|
72510282|NCT02808312|144550989|OTHER|Two-sided 90% CIs were calculated for the ratios of GLSMs of PK parameters between severe hepatic impairment group and the control (normal hepatic function) group.|GLSM ratio|6.2497|||||TWO_SIDED|90.0|4.2965|9.091||||||An ANOVA model with hepatic function group as a fixed effect was fitted to the natural logarithmic transformation of PK parameters (AUCinf) for each cohort.||9.0910|4.2965|
72510283|NCT02808312|144550990|OTHER|Two-sided 90% CIs were calculated for the ratios of GLSMs of PK parameters between mild hepatic impairment group and the control (normal hepatic function) group.|GLSM ratio|1.5703|||||TWO_SIDED|90.0|1.0723|2.2995||||||An ANOVA model with hepatic function group as a fixed effect was fitted to the natural logarithmic transformation of PK parameters (Cmax) for each cohort.||2.2995|1.0723|
72510284|NCT02808312|144550990|OTHER|Two-sided 90% CIs were calculated for the ratios of GLSMs of PK parameters between moderate hepatic impairment group and the control (normal hepatic function) group.|GLSM ratio|1.7343|||||TWO_SIDED|90.0|1.2193|2.4667||||||An ANOVA model with hepatic function group as a fixed effect was fitted to the natural logarithmic transformation of PK parameters (Cmax) for each cohort.||2.4667|1.2193|
72510285|NCT02808312|144550990|OTHER|Two-sided 90% CIs were calculated for the ratios of GLSMs of PK parameters between severe hepatic impairment group and the control (normal hepatic function) group.|GLSM ratio|2.5369|||||TWO_SIDED|90.0|1.7562|3.6648||||||An ANOVA model with hepatic function group as a fixed effect was fitted to the natural logarithmic transformation of PK parameters (Cmax) for each cohort.||3.6648|1.7562|
72510286|NCT02808312|144551001|OTHER|Two-sided 90% CIs were calculated for the ratios of GLSMs of PD parameters between mild hepatic impairment group and the control (normal hepatic function) group.|GLSM ratio|0.8722|||||TWO_SIDED|90.0|0.6827|1.1144||||||||1.1144|0.6827|
72510287|NCT02808312|144551001|OTHER|Two-sided 90% CIs were calculated for the ratios of GLSMs of PD parameters between moderate hepatic impairment group and the control (normal hepatic function) group.|GLSM ratio|1.0731|||||TWO_SIDED|90.0|0.8295|1.3883||||||||1.3883|0.8295|
72481485|NCT02113241|144489530|SUPERIORITY|||||||0.787||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Analysis between before and after the intervention||||0.787
72481486|NCT02113241|144489531|SUPERIORITY|||||||0.129||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Analysis between before and after the intervention||||0.129
72481487|NCT02113241|144489531|SUPERIORITY|||||||0.365||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Analysis between before and after the intervention||||0.365
72481488|NCT02113241|144489532|SUPERIORITY||||||<|0.001||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Analysis between before and after the intervention||||<0.001
72481489|NCT02113241|144489532|SUPERIORITY|||||||0.175||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Analysis between before and after the intervention||||0.175
72481490|NCT02113241|144489533|SUPERIORITY|||||||0.392||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Analysis between before and after the intervention||||0.392
72510288|NCT02808312|144551001|OTHER|Two-sided 90% CIs were calculated for the ratios of GLSMs of PD parameters between severe hepatic impairment group and the control (normal hepatic function) group.|GLSM ratio|1.1475|||||TWO_SIDED|90.0|0.8783|1.4992||||||||1.4992|0.8783|
72510289|NCT02808312|144551002|OTHER|Two-sided 90% CIs were calculated for the ratios of GLSMs of PD parameters between mild hepatic impairment group and the control (normal hepatic function) group.|GLSM ratio|0.8188|||||TWO_SIDED|90.0|0.5837|1.1486||||||||1.1486|0.5837|
72510290|NCT02808312|144551002|OTHER|Two-sided 90% CIs were calculated for the ratios of GLSMs of PD parameters between moderate hepatic impairment group and the control (normal hepatic function) group.|GLSM ratio|1.1323|||||TWO_SIDED|90.0|0.8772|1.4615||||||||1.4615|0.8772|
72510291|NCT02808312|144551002|OTHER|Two-sided 90% CIs were calculated for the ratios of GLSMs of PD parameters between severe hepatic impairment group and the control (normal hepatic function) group.|GLSM ratio|1.3563|||||TWO_SIDED|90.0|1.0468|1.7574||||||||1.7574|1.0468|
72510292|NCT02808312|144551003|OTHER|Two-sided 90% CIs were calculated for the ratios of GLSMs of PD parameters between mild hepatic impairment group and the control (normal hepatic function) group.|GLSM ratio|1.0658|||||TWO_SIDED|90.0|0.8275|1.3726||||||||1.3726|0.8275|
72510293|NCT02808312|144551003|OTHER|Two-sided 90% CIs were calculated for the ratios of GLSMs of PD parameters between moderate hepatic impairment group and the control (normal hepatic function) group.|GLSM ratio|1.2942|||||TWO_SIDED|90.0|0.9663|1.7334||||||||1.7334|0.9663|
72510294|NCT02808312|144551003|OTHER|Two-sided 90% CIs were calculated for the ratios of GLSMs of PD parameters between severe hepatic impairment group and the control (normal hepatic function) group.|GLSM ratio|0.8225|||||TWO_SIDED|90.0|0.5479|1.2347||||||||1.2347|0.5479|
72510295|NCT02808312|144551004|OTHER|Two-sided 90% CIs were calculated for the ratios of GLSMs of PD parameters between mild hepatic impairment group and the control (normal hepatic function) group.|GLSM ratio|1.0806|||||TWO_SIDED|90.0|0.791|1.4762||||||||1.4762|0.7910|
72510296|NCT02808312|144551004|OTHER|Two-sided 90% CIs were calculated for the ratios of GLSMs of PD parameters between moderate hepatic impairment group and the control (normal hepatic function) group.|GLSM ratio|1.3729|||||TWO_SIDED|90.0|0.9663|1.9506||||||||1.9506|0.9663|
72510297|NCT02808312|144551004|OTHER|Two-sided 90% CIs were calculated for the ratios of GLSMs of PD parameters between severe hepatic impairment group and the control (normal hepatic function) group.|GLSM ratio|0.903|||||TWO_SIDED|90.0|0.6142|1.3275||||||||1.3275|0.6142|
72510298|NCT02713230|144551005|SUPERIORITY||LSMD|-117.688|||<|0.0001|TWO_SIDED|95.0|-150.896|-84.48|||ANOVA|||||-84.480|-150.896|<0.0001
72510299|NCT02713230|144551006|SUPERIORITY||LSM treatment ratio|0.22|||<|0.0001|TWO_SIDED|95.0|0.131|0.371|||ANOVA|||||0.371|0.131|<0.0001
72510300|NCT02713230|144551007|SUPERIORITY||Treatment difference|0.116||||0.008|TWO_SIDED|95.0|0.032|0.2|||Cochran-Mantel-Haenszel|||||0.200|0.032|0.008
72510301|NCT02713230|144551008|SUPERIORITY||||||<|0.0001|||||||Log Rank|||||||<0.0001
72481491|NCT02113241|144489533|SUPERIORITY|||||||0.123|||||||Wilcoxon (Mann-Whitney)|||Analysis between before and after the intervention||||0.123
72481492|NCT02113241|144489534|SUPERIORITY|||||||0.176||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Analysis between before and after the intervention||||0.176
72401827|NCT03616912|144310984|SUPERIORITY||Odds Ratio (OR)|0.96||||0.839|TWO_SIDED|95.0|0.63|1.45|||Regression, Logistic|||||1.45|0.63|0.839
72401828|NCT03616912|144310984|SUPERIORITY||Odds Ratio (OR)|1.19||||0.391|TWO_SIDED|95.0|0.8|1.79|||Regression, Logistic|||||1.79|0.80|0.391
72481493|NCT02113241|144489534|SUPERIORITY|||||||0.268||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Analysis between before and after the intervention||||0.268
72481494|NCT02113241|144489535|SUPERIORITY|||||||0.064||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Analysis between before and after the intervention||||0.064
72481495|NCT02113241|144489535|SUPERIORITY|||||||0.462||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Analysis between before and after the intervention||||0.462
72481496|NCT02113241|144489536|SUPERIORITY|||||||0.346||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Analysis between before and after the intervention||||0.346
72481497|NCT02113241|144489536|SUPERIORITY|||||||0.002||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Analysis between before and after the intervention||||0.002
72481498|NCT03249714|144489538|SUPERIORITY||Rate ratio|0.064|||<|0.001|TWO_SIDED|95.0|0.018|0.232|||negative binominal regression model|||||0.232|0.018|<0.001
72481499|NCT03249714|144489539|SUPERIORITY||rate ratio|0.136||||0.003|TWO_SIDED|95.0|0.036|0.513||Statistical significance (2-sided) at the 0.05 level|negative binomial regression|||||0.513|0.036|0.003
72481500|NCT03249714|144489539|SUPERIORITY||rate ratio|0.0|||<|0.001|TWO_SIDED|95.0|0.0|0.0|||negative binominal regression|Indicates statistical significance (2-sided) at the 0.05 level.||||0.000|0.000|< 0.001
72481501|NCT03249714|144489540|SUPERIORITY||Rate ratio|0.284||||0.002|TWO_SIDED|95.0|0.13|0.62|||negative binominal regression|||||0.620|0.130|0.002
72510302|NCT01623531|144551009|SUPERIORITY||Mann-Whitney U test|386.0|STANDARD_ERROR_OF_MEAN|47.5||0.908|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||The distributions of cumulative transfusion units did not differ significantly between patients receiving either RiaSTAP (median = 0, IQR = 0-1) or Placebo (median = 0, IQR = 0.1), U = 386, SE = 47.60, p = .908.|Normality among study outcomes was investigated with Shapiro-Wilk tests, histograms, boxplots, and graphing of residuals, revealing that the data were not normally distributed, and primary outcomes were zero inflated. Therefore, we used non-parametric Mann-Whitney U-tests with a 2-sided type I error rate of 5%. We tested the null hypothesis of no difference in primary and secondary outcomes between groups 24 hours after infusion of the study drug.||||.908
72566819|NCT02312713|144664440|SUPERIORITY||Mean Difference (Final Values)|-0.5||||0.46|TWO_SIDED|95.0|-1.86|0.85|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Wait List Control at 12 months for Timed Up and Go.||0.85|-1.86|0.46
72401829|NCT03616912|144310986|SUPERIORITY||Odds Ratio (OR)|0.94||||0.82|TWO_SIDED|95.0|0.53|1.66|||Regression, Logistic|||||1.66|0.53|0.820
72401830|NCT03616912|144310986|SUPERIORITY||Odds Ratio (OR)|1.18||||0.565|TWO_SIDED|95.0|0.67|2.08|||Regression, Logistic|||||2.08|0.67|0.565
72401831|NCT03616912|144310987|SUPERIORITY||LS Mean Difference Final Values|-0.11|STANDARD_ERROR_OF_MEAN|0.21||0.598|TWO_SIDED|95.0|-0.52|0.3|||Mixed Models Analysis|||||0.30|-0.52|0.598
72401832|NCT03616912|144310987|SUPERIORITY||LS Mean Difference Final Values|-0.09|STANDARD_ERROR_OF_MEAN|0.21||0.674|TWO_SIDED|95.0|-0.5|0.32|||Mixed Models Analysis|||||0.32|-0.50|0.674
72401833|NCT03616912|144310988|SUPERIORITY||LS Mean Difference Final Values|0.02|STANDARD_ERROR_OF_MEAN|0.85||0.979|TWO_SIDED|95.0|-1.65|1.7|||Mixed Models Analysis|||||1.70|-1.65|0.979
72401834|NCT03616912|144310988|SUPERIORITY||LS Mean Difference Final Values|-0.36|STANDARD_ERROR_OF_MEAN|0.86||0.678|TWO_SIDED|95.0|-2.03|1.32|||Mixed Models Analysis|||||1.32|-2.03|0.678
72401835|NCT03616912|144310989|SUPERIORITY||Odds Ratio (OR)|1.02||||0.965|TWO_SIDED|95.0|0.43|2.42|||Regression, Logistic|||||2.42|0.43|0.965
72481502|NCT03249714|144489541|SUPERIORITY||Rate ratio|0.42||||0.119|TWO_SIDED|95.0|0.141|1.25|||negative binominal regression|||||1.250|0.141|0.119
72481503|NCT00394953|144489583|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.63|||<|0.0001|TWO_SIDED|95.0|1.83|3.79|||Chi-squared, Corrected|||The proportion of responders treated with methoxy polyethylene glycol-epoetin beta versus the proportion of responders treated with darbepoetin alpha during the evaluation period.||3.79|1.83|<0.0001
72481504|NCT01592864|144489649|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.4|||<|0.0001|TWO_SIDED|95.0|-0.6|-0.2||No adjustment made for multiple comparisons, as primary comparison was pre-specified.|ANCOVA|ANCOVA with treatment as fixed factor and baseline Schiff Score as covariate.|Difference is 0.454% SnF minus 0.76% NaMFP such that a negative difference favours first named treatment.|Null hypothesis considered change from baseline to be same for both treatments.||-0.2|-0.6|<0.0001
72481505|NCT01592864|144489650|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.4|||<|0.0001|TWO_SIDED|95.0|-0.6|-0.3||No adjustment made for multiple comparisons, as primary comparison was pre-specified.|ANCOVA|ANCOVA with treatment as fixed factor and baseline Schiff Score as covariate.|Difference is 0.454% SnF minus 0.76% NaMFP such that a negative difference favours first named treatment.|Null hypothesis considered change from baseline to be same for both treatments.||-0.3|-0.6|<0.0001
72481506|NCT01592864|144489651|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|16.9|||<|0.0001|TWO_SIDED|95.0|11.1|22.8||No adjustment made for multiple comparisons, as primary comparison was pre-specified.|ANCOVA|ANCOVA with treatment as fixed factor and baseline Schiff Score as covariate.|Difference is 0.454% SnF minus 0.76% NaMFP such that a positive difference favours first named treatment.|Null hypothesis considered change from baseline to be same for both treatments.||22.8|11.1|<0.0001
72481507|NCT01592864|144489652|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|9.6|||<|0.0001|TWO_SIDED|95.0|5.4|13.9||No adjustment made for multiple comparisons, as primary comparison was pre-specified.|ANCOVA|ANCOVA with treatment as fixed factor and baseline Schiff Score as covariate.|Difference is 0.454% SnF minus 0.76% NaMFP such that a positive difference favors first named treatment.|Null hypothesis considered change from baseline to be same for both treatments.||13.9|5.4|<0.0001
72481508|NCT02858349|144489654|SUPERIORITY||Mean Difference (Net)|0.13||||0.0042|TWO_SIDED|95.0|0.05|0.21|||Mixed Models Analysis|||||0.21|0.05|0.0042
72481509|NCT02120716|144489667|OTHER|Logistic regression analysis.|Odds Ratio (OR)|5.5||||0.13|TWO_SIDED|95.0|0.6|51.2|||Regression, Logistic|||||51.2|0.6|0.13
72481510|NCT02120716|144489668|SUPERIORITY||Odds Ratio (OR)|11.7|||<|0.015|TWO_SIDED|95.0|4.2|33.0|||Regression, Logistic|||The reported percentages were captured at two separate time points (baseline, and at 4-Month Follow-Up).||33.0|4.2|<0.015
72481511|NCT01294683|144489675|SUPERIORITY_OR_OTHER||Difference in Percentages|-0.206||||0.654|TWO_SIDED|95.0|-1.434|0.936|||Miettinen and Nurminen|||Periods I/II||0.936|-1.434|0.654
72510303|NCT01623531|144551010|SUPERIORITY||Mean Difference (Net)|-0.498|STANDARD_ERROR_OF_MEAN|0.239||0.047|TWO_SIDED||||||t-test, 2 sided|Unequal variances assumed.|Unequal variances T-test comparing placebo to RiaSTAP.|We tested the null hypothesis of no difference in primary and secondary outcomes between groups 24 hours after infusion of the study drug. Normality among study outcomes was investigated with Shapiro-Wilk tests, histograms, boxplots, and graphing of residuals. For normally distributed data unequal variance t tests were used.||||.047
72510304|NCT01623531|144551011|SUPERIORITY||Mean Difference (Net)|-0.004|STANDARD_ERROR_OF_MEAN|0.0116||0.729|TWO_SIDED||||||t-test, 2 sided|Unequal variances assumed.|Unequal variances T-test comparing placebo to RiaSTAP.|We tested the null hypothesis of no difference in primary and secondary outcomes between groups 24 hours after infusion of the study drug. Normality among study outcomes was investigated with Shapiro-Wilk tests, histograms, boxplots, and graphing of residuals. For normally distributed data unequal variance t tests were used.||||.729
72510305|NCT01623531|144551012|SUPERIORITY||Mean Difference (Net)|-0.321|STANDARD_ERROR_OF_MEAN|3.699||0.93|TWO_SIDED||||||t-test, 2 sided|Unequal variances assumed.|Unequal variances T-test comparing placebo to RiaSTAP.|We tested the null hypothesis of no difference in primary and secondary outcomes between groups 24 hours after infusion of the study drug. Normality among study outcomes was investigated with Shapiro-Wilk tests, histograms, boxplots, and graphing of residuals. For normally distributed data unequal variance t tests were used.||||.93
72510306|NCT01623531|144551013|SUPERIORITY||Mean Difference (Net)|-11.821|STANDARD_ERROR_OF_MEAN|8.471||0.169|TWO_SIDED||||||t-test, 2 sided|Unequal variances assumed.|Unequal variances T-test comparing placebo to RiaSTAP.|||||.169
72481512|NCT01294683|144489675|SUPERIORITY_OR_OTHER||Difference in Percentages|1.304||||0.09|TWO_SIDED|95.0|-0.427|3.768|||Miettinen and Nurminen|||Period III||3.768|-0.427|0.090
72481513|NCT01294683|144489676|SUPERIORITY_OR_OTHER||Difference in Percentages|-0.206||||0.563|TWO_SIDED|95.0|-1.303|0.779|||Miettinen and Nurminen|||Periods I/II||0.779|-1.303|0.563
72481514|NCT01294683|144489676|SUPERIORITY_OR_OTHER||Difference in Percentages|0.87||||0.166|TWO_SIDED|95.0|-0.858|3.118|||Miettinen and Nurminen|||Period III||3.118|-0.858|0.166
72481515|NCT01294683|144489678|SUPERIORITY_OR_OTHER||Difference in Percentages|0.87||||0.166|TWO_SIDED|95.0|-0.858|3.118|||Miettinen and Nurminen|||Period III||3.118|-0.858|0.166
72510307|NCT01623531|144551014|SUPERIORITY||Mann-Whitney U test|450.5|STANDARD_ERROR_OF_MEAN|54.163||0.035|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Normality among study outcomes was investigated with Shapiro-Wilk tests, histograms, boxplots, and graphing of residuals, revealing that this variable was not normally distributed. Therefore, we used non-parametric Mann-Whitney U-tests with a 2-sided type I error rate of 5%. We tested the null hypothesis of no difference in secondary outcomes between groups 24 hours after infusion of the study drug.||||.035
72510308|NCT01623531|144551015|SUPERIORITY||Mann-Whitney U test|337.5|STANDARD_ERROR_OF_MEAN|51.591||0.794|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Normality among study outcomes was investigated with Shapiro-Wilk tests, histograms, boxplots, and graphing of residuals, revealing that this variable was not normally distributed. Therefore, we used non-parametric Mann-Whitney U-tests with a 2-sided type I error rate of 5%. We tested the null hypothesis of no difference in secondary outcomes between groups 24 hours after infusion of the study drug.||||.794
72510309|NCT01623531|144551016|SUPERIORITY||Mann-Whitney U test|335.5|STANDARD_ERROR_OF_MEAN|52.957||0.828|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Normality among study outcomes was investigated with Shapiro-Wilk tests, histograms, boxplots, and graphing of residuals, revealing that this variable was not normally distributed. Therefore, we used non-parametric Mann-Whitney U-tests with a 2-sided type I error rate of 5%. We tested the null hypothesis of no difference in secondary outcomes between groups 24 hours after infusion of the study drug.||||.828
72510310|NCT01623531|144551017|SUPERIORITY||Mann-Whitney U test|396.0|STANDARD_ERROR_OF_MEAN|60.944||0.941|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Normality among study outcomes was investigated with Shapiro-Wilk tests, histograms, boxplots, and graphing of residuals, revealing that this variable was not normally distributed. Therefore, we used non-parametric Mann-Whitney U-tests with a 2-sided type I error rate of 5%. We tested the null hypothesis of no difference in secondary outcomes between groups 24 hours after infusion of the study drug.||||.941
72510311|NCT01623531|144551018|SUPERIORITY||Mann-Whitney U test|494.5|STANDARD_ERROR_OF_MEAN|60.783||0.09|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Normality among study outcomes was investigated with Shapiro-Wilk tests, histograms, boxplots, and graphing of residuals, revealing that this variable was not normally distributed. Therefore, we used non-parametric Mann-Whitney U-tests with a 2-sided type I error rate of 5%. We tested the null hypothesis of no difference in secondary outcomes between groups 24 hours after infusion of the study drug.||||.09
72566820|NCT02312713|144664440|SUPERIORITY||Mean Difference (Final Values)|-0.64||||0.3|TWO_SIDED|95.0|-1.85|0.58|||Mixed Models Analysis|||This is the comparison between Internet Based Exercise Training and Wait List Control at 4 months for Timed Up and Go.||0.58|-1.85|0.3
72481516|NCT01294683|144489681|SUPERIORITY_OR_OTHER||Difference in Percentages|0.617||||0.255|TWO_SIDED|95.0|-0.575|2.023|||Miettinen and Nurminen|||Periods I/II||2.023|-0.575|0.255
72481517|NCT01294683|144489681|SUPERIORITY_OR_OTHER||Difference in Percentages|0.395||||0.69|TWO_SIDED|95.0|-2.091|2.966|||Miettinen and Nurminen|||Period III||2.966|-2.091|0.690
72481518|NCT01294683|144489682|SUPERIORITY_OR_OTHER||Difference in Percentages|0.0|||>|0.999|TWO_SIDED|95.0|-0.967|0.967|||Miettinen and Nurminen|||Periods I/II||0.967|-0.967|>0.999
72481519|NCT01294683|144489683|SUPERIORITY_OR_OTHER||Difference in Percentages|-1.029|||||TWO_SIDED|95.0|-7.301|5.252|||Miettinen and Nurminen||Miettinen and Nurminen Method|Periods I/II||5.252|-7.301|
72481520|NCT01294683|144489683|SUPERIORITY_OR_OTHER||Difference in Percentages|0.889|||||TWO_SIDED|95.0|-7.599|9.338|||||Miettinen and Nurminen Method|Period III||9.338|-7.599|
72481521|NCT01294683|144489684|SUPERIORITY_OR_OTHER||Difference in Percentages|-0.412|||||TWO_SIDED|95.0|-4.28|3.45||||||Periods I/II||3.450|-4.280|
72481522|NCT01294683|144489684|SUPERIORITY_OR_OTHER||Difference in Percentages|-0.533|||||TWO_SIDED|95.0|-3.916|2.619|||||Miettinen and Nurminen Method|Period III||2.619|-3.916|
72481523|NCT00412971|144489696|SUPERIORITY_OR_OTHER||difference in recurrence rate|0.25||||0.05|TWO_SIDED|95.0|||||Cochran-Mantel-Haenszel|||||||0.05
72401836|NCT03616912|144310989|SUPERIORITY||Odds Ratio (OR)|1.22||||0.661|TWO_SIDED|95.0|0.51|2.92|||Regression, Logistic|||||2.92|0.51|0.661
72401837|NCT03616912|144310990|SUPERIORITY||LS Mean Difference Final Values|0.24|STANDARD_ERROR_OF_MEAN|0.43||0.578|TWO_SIDED|95.0|-0.61|1.08|||Mixed Models Analysis|||||1.08|-0.61|0.578
72481524|NCT05266586|144489781|SUPERIORITY||Least Squares (LS) Means|-58.38|STANDARD_ERROR_OF_MEAN|5.138|<|0.0001|TWO_SIDED|95.0|-68.59|-48.18|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-48.18|-68.59|<.0001
72481525|NCT05266586|144489782|SUPERIORITY||Least Squares (LS) Means|-58.38|STANDARD_ERROR_OF_MEAN|5.138|<|0.0001|TWO_SIDED|95.0|-68.59|-48.18|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-48.18|-68.59|<.0001
72481526|NCT05266586|144489783|SUPERIORITY||Least Squares (LS) Means|-58.38|STANDARD_ERROR_OF_MEAN|5.138|<|0.0001|TWO_SIDED|95.0|-68.59|-48.18|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-48.18|-68.59|<.0001
72481527|NCT05266586|144489784|SUPERIORITY||Least Squares (LS) Means|-58.15|STANDARD_ERROR_OF_MEAN|5.195|<|0.0001|TWO_SIDED|95.0|-68.47|-47.83|||ANCOVA|||||-47.83|-68.47|<.0001
72481528|NCT05266586|144489785|SUPERIORITY||Least Squares (LS) Means|-58.15|STANDARD_ERROR_OF_MEAN|5.195|<|0.0001|TWO_SIDED|95.0|-68.47|-47.83|||ANCOVA|||||-47.83|-68.47|<.0001
72481529|NCT05266586|144489786|SUPERIORITY||Least Squares (LS) Means|-58.15|STANDARD_ERROR_OF_MEAN|5.195|<|0.0001|TWO_SIDED|95.0|-68.47|-47.83|||ANCOVA|||||-47.83|-68.47|<.0001
72481530|NCT05266586|144489787|SUPERIORITY||Least Squares (LS) Means|-38.35|STANDARD_ERROR_OF_MEAN|5.397|<|0.0001|TWO_SIDED|95.0|-49.07|-27.63|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-27.63|-49.07|<.0001
72481531|NCT05266586|144489788|SUPERIORITY||Least Squares (LS) Means|-38.35|STANDARD_ERROR_OF_MEAN|5.397|<|0.0001|TWO_SIDED|95.0|-49.07|-27.63|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-27.63|-49.07|<.0001
72481532|NCT05266586|144489789|SUPERIORITY||Least Squares (LS) Means|-38.35|STANDARD_ERROR_OF_MEAN|5.397|<|0.0001|TWO_SIDED|95.0|-49.07|-27.63|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-27.63|-49.07|<.0001
72481533|NCT05266586|144489790|SUPERIORITY||Least Squares (LS) Means|-37.21|STANDARD_ERROR_OF_MEAN|5.465|<|0.0001|TWO_SIDED|95.0|-48.07|-26.35|||ANCOVA|||||-26.35|-48.07|<.0001
72481534|NCT05266586|144489791|SUPERIORITY||Least Squares (LS) Means|-37.21|STANDARD_ERROR_OF_MEAN|5.465|<|0.0001|TWO_SIDED|95.0|-48.07|-26.35|||ANCOVA|||||-26.35|-48.07|<.0001
72481535|NCT05266586|144489792|SUPERIORITY||Least Squares (LS) Means|-37.21|STANDARD_ERROR_OF_MEAN|5.465|<|0.0001|TWO_SIDED|95.0|-48.07|-26.35|||ANCOVA|||||-26.35|-48.07|<.0001
72481536|NCT05266586|144489793|SUPERIORITY||Least Squares (LS) Means|-35.68|STANDARD_ERROR_OF_MEAN|3.8|<|0.0001|TWO_SIDED|95.0|-43.23|-28.13|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-28.13|-43.23|<.0001
72401838|NCT03616912|144310990|SUPERIORITY||LS Mean Difference Final Values|-0.44|STANDARD_ERROR_OF_MEAN|0.433||0.309|TWO_SIDED|95.0|-1.29|0.41|||Mixed Models Analysis|||||0.41|-1.29|0.309
72401839|NCT03616912|144310991|SUPERIORITY||LS Mean Difference Final Values|-0.29|STANDARD_ERROR_OF_MEAN|0.277||0.287|TWO_SIDED|95.0|-0.84|0.25|||Mixed Models Analysis|||||0.25|-0.84|0.287
72401840|NCT03616912|144310991|SUPERIORITY||LS Mean Difference Final Values|-0.44|STANDARD_ERROR_OF_MEAN|0.278||0.113|TWO_SIDED|95.0|-0.99|0.11|||Mixed Models Analysis|||||0.11|-0.99|0.113
72481537|NCT05266586|144489794|SUPERIORITY||Least Squares (LS) Means|-35.68|STANDARD_ERROR_OF_MEAN|3.8|<|0.0001|TWO_SIDED|95.0|-43.23|-28.13|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-28.13|-43.23|<.0001
72481538|NCT05266586|144489795|SUPERIORITY||Least Squares (LS) Means|-35.68|STANDARD_ERROR_OF_MEAN|3.8|<|0.0001|TWO_SIDED|95.0|-43.23|-28.13|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-28.13|-43.23|<.0001
72481539|NCT05266586|144489796|SUPERIORITY||Least Squares (LS) Means|-22.28|STANDARD_ERROR_OF_MEAN|3.991|<|0.0001|TWO_SIDED|95.0|-30.21|-14.36|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-14.36|-30.21|<.0001
72481540|NCT05266586|144489797|SUPERIORITY||Least Squares (LS) Means|-22.28|STANDARD_ERROR_OF_MEAN|3.991|<|0.0001|TWO_SIDED|95.0|-30.21|-14.36|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-14.36|-30.21|<.0001
72481541|NCT05266586|144489798|SUPERIORITY||Least Squares (LS) Means|-22.28|STANDARD_ERROR_OF_MEAN|3.991|<|0.0001|TWO_SIDED|95.0|-30.21|-14.36|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-14.36|-30.21|<.0001
72481542|NCT01005459|144489812|OTHER|unpaired t-test|||||>|0.05|||||||unpaired t-test compared between groups|||||||>0.05
72481543|NCT01005459|144489812|OTHER|unpaired t-test compared between groups|||||>|0.05|||||||unpaired t-test compared between groups|||||||>0.05
72481544|NCT03622619|144489835|OTHER|||||||0.65|||||||Wilcoxon (Mann-Whitney)|||||||0.65
72481545|NCT03622619|144489836|SUPERIORITY|||||||0.014|||||||Wilcoxon (Mann-Whitney)|||||||0.014
72481546|NCT03622619|144489837|SUPERIORITY|||||||0.055|||||||Wilcoxon (Mann-Whitney)|||||||0.055
72481547|NCT03622619|144489838|SUPERIORITY|||||||0.9|||||||Wilcoxon (Mann-Whitney)|Burning/stinging||||||0.90
72481548|NCT03622619|144489838|SUPERIORITY|||||||0.3|||||||Wilcoxon (Mann-Whitney)|Grittiness/foreign body sensation||||||0.30
72481549|NCT03622619|144489838|SUPERIORITY|||||||0.66||||||Dryness|Wilcoxon (Mann-Whitney)|||||||0.66
72481550|NCT03622619|144489838|SUPERIORITY|||||||0.14||||||Blurred vision|Wilcoxon (Mann-Whitney)|||||||0.14
72481551|NCT03622619|144489838|SUPERIORITY|||||||0.3||||||Overall discomfort|Wilcoxon (Mann-Whitney)|||||||0.30
72481552|NCT02181387|144489839|OTHER|unpaired t-test compared between groups|||||>|0.05|||||||unpaired t-test compared between groups|||||||>0.05
72481553|NCT02181387|144489839|OTHER|unpaired t-test compared between groups|||||>|0.05|||||||unpaired t-test compared between groups|||||||>0.05
72510312|NCT01623531|144551019|SUPERIORITY||Mann-Whitney U test|418.5|STANDARD_ERROR_OF_MEAN|60.93||0.658|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Normality among study outcomes was investigated with Shapiro-Wilk tests, histograms, boxplots, and graphing of residuals, revealing that this variable was not normally distributed. Therefore, we used non-parametric Mann-Whitney U-tests with a 2-sided type I error rate of 5%. We tested the null hypothesis of no difference in secondary outcomes between groups 24 hours after infusion of the study drug.||||.658
72510313|NCT01623531|144551020|SUPERIORITY||Mann-Whitney U test|472.5|STANDARD_ERROR_OF_MEAN|60.727||0.182|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Normality among study outcomes was investigated with Shapiro-Wilk tests, histograms, boxplots, and graphing of residuals, revealing that this variable was not normally distributed. Therefore, we used non-parametric Mann-Whitney U-tests with a 2-sided type I error rate of 5%. We tested the null hypothesis of no difference in secondary outcomes between groups 24 hours after infusion of the study drug.||||.182
72510314|NCT01623531|144551021|SUPERIORITY||Mann-Whitney U test|428.0|STANDARD_ERROR_OF_MEAN|60.919||0.549|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Normality among study outcomes was investigated with Shapiro-Wilk tests, histograms, boxplots, and graphing of residuals, revealing that this variable was not normally distributed. Therefore, we used non-parametric Mann-Whitney U-tests with a 2-sided type I error rate of 5%. We tested the null hypothesis of no difference in secondary outcomes between groups 24 hours after infusion of the study drug.||||.549
72510315|NCT01623531|144551022|SUPERIORITY||Mann-Whitney U test|530.5|STANDARD_ERROR_OF_MEAN|60.816||0.022|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||The distribution of FIBTEM MCF (maximum clot firmness) was significantly different between RiaSTAP (median = 27 mm, IQR = 24, 30), and placebo (median = 23 mm, IQR = 22, 27) groups, U-test = 530.5, SE = 60.816, p = .022).|Normality among study outcomes was investigated with Shapiro-Wilk tests, histograms, boxplots, and graphing of residuals, revealing that the FIBTEM MCF data was not normally distributed. Therefore, we used non-parametric Mann-Whitney U-tests with a 2-sided type I error rate of 5%. We tested the null hypothesis of no difference in secondary outcomes between groups 24 hours after infusion of the study drug.||||.022
72510316|NCT01623531|144551023|SUPERIORITY||Mann-Whitney U test|437.0|STANDARD_ERROR_OF_MEAN|60.93||0.455|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Normality among study outcomes was investigated with Shapiro-Wilk tests, histograms, boxplots, and graphing of residuals, revealing that this variable was not normally distributed. Therefore, we used non-parametric Mann-Whitney U-tests with a 2-sided type I error rate of 5%. We tested the null hypothesis of no difference in secondary outcomes between groups 24 hours after infusion of the study drug.||||.455
72510317|NCT01623531|144551024|SUPERIORITY||Mann-Whitney U test|432.5|STANDARD_ERROR_OF_MEAN|60.819||0.5|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Normality among study outcomes was investigated with Shapiro-Wilk tests, histograms, boxplots, and graphing of residuals, revealing that this variable was not normally distributed. Therefore, we used non-parametric Mann-Whitney U-tests with a 2-sided type I error rate of 5%. We tested the null hypothesis of no difference in secondary outcomes between groups 24 hours after infusion of the study drug.||||.5
72510318|NCT01623531|144551025|SUPERIORITY|||||||1|||||||Fisher Exact|Significance (2-sided) using Fisher's Exact Test.||||||1.0
72510319|NCT04184622|144551040|SUPERIORITY||Least Square (LS) Mean Difference (Net)|-13.5|||<|0.001|TWO_SIDED|95.0|-14.6|-12.5|||Mixed Models Analysis|||||-12.5|-14.6|<0.001
72510320|NCT04184622|144551040|SUPERIORITY||LS Mean Difference (Net)|-18.9|||<|0.001|TWO_SIDED|95.0|-20.0|-17.8|||Mixed Models Analysis|||||-17.8|-20.0|<0.001
72510321|NCT04184622|144551040|SUPERIORITY||LS Mean Difference (Net)|-20.1|||<|0.001|TWO_SIDED|95.0|-21.2|-19.0|||Mixed Models Analysis|||||-19.0|-21.2|<0.001
72510322|NCT04184622|144551041|SUPERIORITY||Odds Ratio (OR)|23.99|||<|0.001|TWO_SIDED|95.0|17.43|33.02|||Regression, Logistic|||||33.02|17.43|<0.001
72510323|NCT04184622|144551041|SUPERIORITY||Odds Ratio (OR)|73.63|||<|0.001|TWO_SIDED|95.0|46.98|115.39|||Regression, Logistic|||||115.39|46.98|<0.001
72510324|NCT04184622|144551041|SUPERIORITY||Odds Ratio (OR)|75.48|||<|0.001|TWO_SIDED|95.0|47.86|119.03|||Regression, Logistic|||||119.03|47.86|<0.001
72510325|NCT04184622|144551042|SUPERIORITY||LS Mean Difference (Net)|-10.7|||<|0.001|TWO_SIDED|95.0|-11.2|-10.1|||Mixed Models Analysis|||||-10.1|-11.2|<0.001
72510326|NCT04184622|144551043|SUPERIORITY||Odds Ratio (OR)|19.03|||<|0.001|TWO_SIDED|95.0|14.15|25.6|||Regression, Logistic|||||25.60|14.15|<0.001
72510327|NCT04184622|144551043|SUPERIORITY||Odds Ratio (OR)|44.17|||<|0.001|TWO_SIDED|95.0|31.75|61.45|||Regression, Logistic|||||61.45|31.75|<.001
72510328|NCT04184622|144551043|SUPERIORITY||Odds Ratio (OR)|65.64|||<|0.001|TWO_SIDED|95.0|45.94|93.77|||Regression, Logistic|||||93.77|45.94|<.001
72510329|NCT04184622|144551044|SUPERIORITY||Odds Ratio (OR)|17.08|||<|0.001|TWO_SIDED|95.0|11.83|24.66|||Regression, Logistic|||||24.66|11.83|<0.001
72510330|NCT04184622|144551044|SUPERIORITY||Odds Ratio (OR)|51.84|||<|0.001|TWO_SIDED|95.0|35.42|75.88|||Regression, Logistic|||||75.88|35.42|<0.001
72510331|NCT04184622|144551044|SUPERIORITY||Odds Ratio (OR)|66.63|||<|0.001|TWO_SIDED|95.0|45.23|98.16|||Regression, Logistic|||||98.16|45.23|<0.001
72510332|NCT04184622|144551045|SUPERIORITY||Odds Ratio (OR)|36.93|||<|0.001|TWO_SIDED|95.0|18.37|74.22|||Regression, Logistic|||||74.22|18.37|<0.001
72510333|NCT04184622|144551045|SUPERIORITY||Odds Ratio (OR)|109.45|||<|0.001|TWO_SIDED|95.0|54.5|219.81|||Regression, Logistic|||||219.81|54.50|<0.001
72510334|NCT04184622|144551045|SUPERIORITY||Odds Ratio (OR)|150.59|||<|0.001|TWO_SIDED|95.0|74.85|302.97|||Regression, Logistic|||||302.97|74.85|<0.001
72510335|NCT04184622|144551046|SUPERIORITY||LS Mean Difference (Net)|-11.2|||<|0.001|TWO_SIDED|95.0|-12.3|-10.0|||Mixed Models Analysis|||||-10.0|-12.3|<0.001
72510336|NCT04184622|144551046|SUPERIORITY||LS Mean Difference (Net)|-16.0|||<|0.001|TWO_SIDED|95.0|-17.2|-14.9|||Mixed Models Analysis|||||-14.9|-17.2|<0.001
72510337|NCT04184622|144551046|SUPERIORITY||LS Mean Difference (Net)|-16.5|||<|0.001|TWO_SIDED|95.0|-17.7|-15.4|||Mixed Models Analysis|||||-15.4|-17.7|<0.001
72510338|NCT04184622|144551047|SUPERIORITY||LS Mean Difference (Net)|2.3|||<|0.001|TWO_SIDED|95.0|1.6|2.9|||ANCOVA|||||2.9|1.6|<0.001
72510339|NCT04184622|144551048|SUPERIORITY||Estimate Difference|-22.7|||<|0.001|TWO_SIDED|95.0|-25.6|-19.8|||Mixed Models Analysis|||||-19.8|-25.6|<0.001
72510340|NCT04184622|144551049|SUPERIORITY||Estimate Difference|-4.91|||<|0.001|TWO_SIDED|95.0|-6.4|-3.41|||Mixed Models Analysis|||||-3.41|-6.40|<0.001
72510341|NCT04184622|144551050|SUPERIORITY||Estimate Difference|7.65|||<|0.001|TWO_SIDED|95.0|5.85|9.49|||Mixed Models Analysis|||||9.49|5.85|<0.001
72401841|NCT01649375|144310994|SUPERIORITY||Odds Ratio (OR)|1.82||||0.0967|TWO_SIDED|95.0|0.9|3.67|||Regression, Logistic|Missing ASAS responses considered nonresponders||||3.67|0.90|0.0967
72401842|NCT01649375|144310994|SUPERIORITY||Odds Ratio (OR)|4.38|||<|0.0001|TWO_SIDED|95.0|2.14|8.96|||Regression, Logistic|Missing ASAS responses considered nonresponders||||8.96|2.14|<.0001
72401843|NCT01649375|144310995|SUPERIORITY||Odds Ratio (OR)|2.99||||0.0194|TWO_SIDED|95.0|1.19|7.48|||Regression, Logistic|Missing ASAS responses considered nonresponders||||7.48|1.19|0.0194
72401844|NCT01649375|144310995|SUPERIORITY||Odds Ratio (OR)|5.07|||<|0.0004|TWO_SIDED|95.0|2.06|12.44|||Regression, Logistic|Missing ASAS responses considered nonresponders||||12.44|2.06|<.0004
72401845|NCT01649375|144310996|SUPERIORITY||Mean Difference (Net)|0.54|||<|0.0001|TWO_SIDED|95.0|0.41|0.71|||Mixed Models Analysis|||||0.71|0.41|<0.0001
72401846|NCT01649375|144310996|SUPERIORITY||Mean Difference (Net)|0.49|||<|0.0001|TWO_SIDED|95.0|0.37|0.64|||Mixed Models Analysis|||||0.64|0.37|<0.0001
72401847|NCT01649375|144310997|SUPERIORITY||Odds Ratio (OR)|6.13||||0.0003|TWO_SIDED|95.0|2.31|16.26|||Regression, Logistic|Missing ASAS responses considered nonresponders||||16.26|2.31|0.0003
72401848|NCT01649375|144310997|SUPERIORITY||Odds Ratio (OR)|9.15|||<|0.0001|TWO_SIDED|95.0|3.47|24.12|||Regression, Logistic|Missing ASAS responses considered nonresponders||||24.12|3.47|<.0001
72401849|NCT01649375|144310998|SUPERIORITY||Mean Difference (Net)|-1.07|STANDARD_ERROR_OF_MEAN|0.353|<|0.0001|TWO_SIDED|95.0|-1.77|-0.37|||Mixed Models Analysis|||||-0.37|-1.77|<0.0001
72481554|NCT01101477|144489855|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||Chi-squared|||The patients with at lease one episode of hypoxemia (SPaO2\<90%) during FB were analyzed by Chi-square test. P value less 0.05 means significance, 2-sided.||||0.05
72481555|NCT02382016|144489861|SUPERIORITY||ratio of geometric means|0.65||||0.0001|TWO_SIDED|95.0|0.59|0.72|||ANCOVA|ANCOVA model adjusted by treatment, background PAH-specific therapy at baseline and region as factors \& log-transformed PVR at baseline as a covariate||The null hypothesis (change of PVR at Week 12 as a ratio of baseline PVR in subjects treated with placebo or macitentan is the same) is tested on the primary endpoint by means of an analysis of covariance (ANCOVA) model on the log(e) transformed ratio of PVR at Week 12 to baseline PVR.||0.72|0.59|0.0001
72401850|NCT01649375|144310998|SUPERIORITY||Mean Difference (Net)|-1.34|STANDARD_ERROR_OF_MEAN|0.353||0.0002|TWO_SIDED|95.0|-2.04|-0.65|||Mixed Models Analysis|||||-0.65|-2.04|0.0002
72401851|NCT01649375|144310999|SUPERIORITY||Mean Difference (Net)|2.84|STANDARD_ERROR_OF_MEAN|1.108||0.011|TWO_SIDED|95.0|0.66|5.03|||Mixed Models Analysis|||||5.03|0.66|0.0110
72401852|NCT01649375|144310999|SUPERIORITY||Mean Difference (Net)|4.14|STANDARD_ERROR_OF_MEAN|1.105||0.0002|TWO_SIDED|95.0|1.96|6.32|||Mixed Models Analysis|||||6.32|1.96|0.0002
72510342|NCT04184622|144551051|SUPERIORITY||LS Mean Difference (Net)|-6.8|||<|0.001|TWO_SIDED|95.0|-7.9|-5.7|||Mixed Models Analysis|||||-5.7|-7.9|<0.001
72510343|NCT04184622|144551052|SUPERIORITY||Estimate Difference|-41.2|||<|0.001|TWO_SIDED|95.0|-44.9|-37.3|||Mixed Models Analysis|||||-37.3|-44.9|<0.001
72510344|NCT04184622|144551053|SUPERIORITY||LS Mean Difference (Net)|-13.2|||<|0.0001|TWO_SIDED|95.0|-15.3|-11.1|||Mixed Models Analysis|||||-11.1|-15.3|<.0001
72401853|NCT01649375|144311000|SUPERIORITY||Mean Difference (Net)|-1.96|STANDARD_ERROR_OF_MEAN|0.748||0.0096|TWO_SIDED|95.0|-3.43|-0.48|||Mixed Models Analysis|||||-0.48|-3.43|0.0096
72401854|NCT01649375|144311000|SUPERIORITY||Mean Difference (Net)|-2.63|STANDARD_ERROR_OF_MEAN|0.743||0.0005|TWO_SIDED|95.0|-4.09|-1.16|||Mixed Models Analysis|||||-1.16|-4.09|0.0005
72401855|NCT01649375|144311001|SUPERIORITY||Odds Ratio (OR)|4.28||||0.0325|TWO_SIDED|95.0|1.13|16.21|||Regression, Logistic|Missing ASAS responses considered nonresponders||||16.21|1.13|0.0325
72401856|NCT01649375|144311001|SUPERIORITY||Odds Ratio (OR)|3.91||||0.0471|TWO_SIDED|95.0|1.02|15.01|||Regression, Logistic|Missing ASAS responses considered nonresponders||||15.01|1.02|0.0471
72401857|NCT01124604|144311002|SUPERIORITY_OR_OTHER||Least Square (LS) Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.46||||95.0|-1.04|0.8|||||Test for no difference between treatments was derived from Analysis of covariance (ANCOVA) model with factors treatment, disease and Baseline pain intensity as covariate.|||0.80|-1.04|
72401858|NCT01856790|144311023|SUPERIORITY_OR_OTHER_LEGACY|||||||0.05|||||||Wilcoxon Matched Pairs signed rank tests|||||||0.05
72401859|NCT01856790|144311024|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002|||||||Wilcoxon Matched Pairs signed rank tests|||||||0.002
72401860|NCT01856790|144311026|SUPERIORITY_OR_OTHER_LEGACY|||||||0.97|||||||Wilcoxon Matched Pairs signed rank tests|||||||0.97
72401861|NCT01856790|144311030|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|||||||Wilcoxon Matched Pairs signed rank tests|||||||.001
72401862|NCT01856790|144311031|SUPERIORITY_OR_OTHER_LEGACY|||||||0.005|||||||Wilcoxon Matched Pairs signed rank tests|||||||0.005
72401863|NCT04091646|144311033|SUPERIORITY||Odds Ratio (OR)|4.95|||<|0.0001|TWO_SIDED|95.0|2.51|9.76|||Cochran-Mantel-Haenszel|Stratification by pooled study site and baseline IGA per randomization with multiple imputation of missing data|Common OR stratified by pooled study site and baseline IGA per randomization with multiple imputation of missing data.|IGA Success at Week 8 Odds Ratio||9.76|2.51|<0.0001
72401864|NCT04091646|144311034|SUPERIORITY||Odds Ratio (OR)|3.31||||0.0033|TWO_SIDED|95.0|1.46|7.52|||Cochran-Mantel-Haenszel|Stratification by pooled study site and baseline IGA per randomization with multiple imputation of missing data|Common OR stratified by pooled study site and baseline IGA per randomization with multiple imputation of missing data.|IGA Success at Week 2 Odds Ratio||7.52|1.46|0.0033
72401865|NCT04091646|144311034|SUPERIORITY||Odds Ratio (OR)|3.78||||0.0002|TWO_SIDED|95.0|1.94|7.38|||Cochran-Mantel-Haenszel|Stratification by pooled study site and baseline IGA per randomization with multiple imputation of missing data|Common OR stratified by pooled study site and baseline IGA per randomization with multiple imputation of missing data.|IGA Success at Week 4 Odds Ratio||7.38|1.94|0.0002
72401866|NCT04091646|144311035|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||Week 2 Erythema Score||||<0.0001
72401867|NCT04091646|144311035|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||Week 4 Erythema Score||||<0.0001
72401868|NCT04091646|144311035|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||Week 8 Erythema Score||||<0.0001
72401869|NCT04091646|144311036|SUPERIORITY||Odds Ratio (OR)|5.05||||0.0065|TWO_SIDED|95.0|1.49|17.13|||Cochran-Mantel-Haenszel|Stratification by pooled study site and baseline IGA per randomization with no imputation of missing data||Erythema Success at Week 2||17.13|1.49|0.0065
72401870|NCT04091646|144311036|SUPERIORITY||Odds Ratio (OR)|5.36||||0.0002|TWO_SIDED|95.0|2.15|13.38|||Cochran-Mantel-Haenszel|Stratification by pooled study site and baseline IGA per randomization with no imputation of missing data||Erythema Success at Week 4||13.38|2.15|0.0002
72401871|NCT04091646|144311036|SUPERIORITY||Odds Ratio (OR)|3.15||||0.0021|TWO_SIDED|95.0|1.5|6.63|||Cochran-Mantel-Haenszel|Stratification by pooled study site and baseline IGA per randomization with no imputation of missing data||Erythema Success at Week 8||6.63|1.50|0.0021
72401872|NCT04091646|144311037|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||Week 2 Scaling Score||||<0.0001
72401873|NCT04091646|144311037|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||Week 4 Scaling Score||||<0.0001
72401874|NCT04091646|144311037|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||Week 8 Scaling Score||||<0.0001
72401875|NCT04091646|144311038|SUPERIORITY||Odds Ratio (OR)|1.98||||0.0759|TWO_SIDED|95.0|0.9|4.33|||Cochran-Mantel-Haenszel|Stratification by pooled study site and baseline IGA per randomization with no imputation of missing data|Common OR stratified by pooled study site and baseline IGA per randomization with no imputation of missing data.|Scaling Success at Week 2||4.33|0.90|0.0759
72401876|NCT04091646|144311038|SUPERIORITY||Odds Ratio (OR)|2.33||||0.0122|TWO_SIDED|95.0|1.18|4.61|||Cochran-Mantel-Haenszel|Stratification by pooled study site and baseline IGA per randomization with no imputation of missing data|Common OR stratified by pooled study site and baseline IGA per randomization with no imputation of missing data.|Scaling Success at Week 4||4.61|1.18|0.0122
72401877|NCT04091646|144311038|SUPERIORITY||Odds Ratio (OR)|3.37||||0.0003|TWO_SIDED|95.0|1.74|6.55|||Cochran-Mantel-Haenszel|Stratification by pooled study site and baseline IGA per randomization with no imputation of missing data|Common OR stratified by pooled study site and baseline IGA per randomization with no imputation of missing data.|Scaling Success at Week 8||6.55|1.74|0.0003
72401878|NCT04091646|144311040|SUPERIORITY||Odds Ratio (OR)|3.62||||0.0007|TWO_SIDED|95.0|1.72|7.63|||Cochran-Mantel-Haenszel|Stratification by pooled study site and baseline IGA per randomization with no imputation of missing data|Common OR stratified by pooled study site and baseline IGA per randomization with no imputation of missing data.|WI-NRS Success at Week 2||7.63|1.72|0.0007
72401879|NCT04091646|144311040|SUPERIORITY||Odds Ratio (OR)|3.3||||0.0009|TWO_SIDED|95.0|1.63|6.68|||Cochran-Mantel-Haenszel|Stratification by pooled study site and baseline IGA per randomization with no imputation of missing data|Common OR stratified by pooled study site and baseline IGA per randomization with no imputation of missing data.|WI-NRS Success at Week 4||6.68|1.63|0.0009
72401880|NCT04091646|144311040|SUPERIORITY||Odds Ratio (OR)|3.19||||0.0007|TWO_SIDED|95.0|1.6|6.35|||Cochran-Mantel-Haenszel|Stratification by pooled study site and baseline IGA per randomization with no imputation of missing data|Common OR stratified by pooled study site and baseline IGA per randomization with no imputation of missing data.|WI-NRS Success at Week 8||6.35|1.60|0.0007
72401881|NCT01762943|144311041|SUPERIORITY|||||||0.27|||||||repeated measures ANOVA|F=1.40, df=2,26||||||.27
72481556|NCT02382016|144489862|SUPERIORITY||Least squares (LS) mean difference|9.73||||0.4264|TWO_SIDED|95.0|-14.5|33.95||No adjustment was made for multiplicity for secondary endpoints, therefore all corresponding p-values provided are of an exploratory nature.|mixed-effect model repeated measure||The estimated value refers to a between-treatment analysis of change from baseline to Week 12 in 6MWD (LS mean difference macitentan 10 mg - placebo).|The main analysis on 6MWD was performed using a mixed-effect model repeated measure (MMRM) adjusted for treatment, visit, region, PAH-specific therapy at baseline, and treatment-by-visit interaction as factors, and baseline 6MWD and WHO functional class (FC) as covariates.||33.95|-14.50|0.4264
72401882|NCT01762943|144311042|SUPERIORITY|||||||0.018|||||||repeated measures ANOVA|F=6.29, df=1,28||||||.018
72401883|NCT02120950|144311054|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.7||||0.548|TWO_SIDED|95.0|-2.9|1.6|||ANCOVA|||||1.6|-2.9|0.5480
72401884|NCT02120950|144311055|SUPERIORITY_OR_OTHER_LEGACY||treatment difference in %|0.6||||0.7402|TWO_SIDED|95.0|-3.1|4.3|||Cochran-Mantel-Haenszel|||||4.3|-3.1|0.7402
72401885|NCT02120950|144311057|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.1||||0.0682|TWO_SIDED|95.0|0.0|0.2|||ANCOVA||Point estimate, 95% CI and p-value are based on treatment difference (AFL-sham - AFL-PDT) of the LS mean changes using an ANOVA model with treatment group and ethnicity and qualification for rescue therapy at Week 12 as fixed effects.|||0.2|0.0|0.0682
72401886|NCT02120950|144311058|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.1||||0.164|TWO_SIDED|95.0|-0.1|0.3|||ANCOVA||Point estimate, 95% CI and p-value are based on treatment difference (AFL-sham - AFL-PDT) of the LS mean changes using an ANOVA model with treatment group and ethnicity and qualification for rescue therapy at Week 12 as fixed effects.|||0.3|-0.1|0.1640
72401887|NCT02120950|144311061|SUPERIORITY_OR_OTHER_LEGACY||treatment difference in %|-5.6||||0.2348|TWO_SIDED|95.0|-14.9|3.7|||Cochran-Mantel-Haenszel|The p-value is calculated from the 2-sided Cochran-Mantel-Haenszel test adjusted by ethnicity and qualification for rescue therapy at Week 12|CI is based on the treatment difference in % (AFL-sham - AFL-PDT) using the Mantel-Haenszel weighting scheme adjusted by ethnicity and qualification for rescue therapy at Week 12|Category of Gained ≥ 5||3.7|-14.9|0.2348
72401888|NCT02120950|144311061|SUPERIORITY_OR_OTHER_LEGACY||treatment difference in %|-2.2||||0.6877|TWO_SIDED|95.0|-13.1|8.6|||Cochran-Mantel-Haenszel|The p-value is calculated from the 2-sided Cochran-Mantel-Haenszel test adjusted by ethnicity and qualification for rescue therapy at Week 12|CI is based on the treatment difference in % (AFL-sham - AFL-PDT) using the Mantel-Haenszel weighting scheme adjusted by ethnicity and qualification for rescue therapy at Week 12|Category of Gained ≥ 10||8.6|-13.1|0.6877
72401889|NCT02120950|144311061|SUPERIORITY_OR_OTHER_LEGACY||treatment difference in %|-4.0||||0.4556|TWO_SIDED|95.0|-14.5|6.5|||Cochran-Mantel-Haenszel|The p-value is calculated from the 2-sided Cochran-Mantel-Haenszel test adjusted by ethnicity and qualification for rescue therapy at Week 12|CI is based on the treatment difference in % (AFL-sham - AFL-PDT) using the Mantel-Haenszel weighting scheme adjusted by ethnicity and qualification for rescue therapy at Week 12|Category of Gained ≥ 15||6.5|-14.5|0.4556
72481557|NCT02382016|144489863|SUPERIORITY||Odds Ratio (OR)|6.253||||0.1278|TWO_SIDED|95.0|0.714|298.376||No adjustment was made for multiplicity for secondary endpoints, therefore all corresponding p-values provided are of an exploratory nature.|Regression, Logistic|||A logistic regression model (exact) adjusted for treatment, PAH-specific therapy at baseline, and region as covariates was used to analyze worsening in WHO FC.||298.376|0.714|0.1278
72566821|NCT02312713|144664440|SUPERIORITY||Mean Difference (Final Values)|-1.22||||0.08|TWO_SIDED|95.0|-2.61|0.16|||Mixed Models Analysis|||This is the comparison between Internet Based Exercise Training and Wait List Control at 12 months for Timed Up and Go.||0.16|-2.61|0.08
72481558|NCT02382016|144489864|SUPERIORITY||ratio of geometric means|0.874||||0.3951|TWO_SIDED|95.0|0.639|1.196||No adjustment was made for multiplicity for secondary endpoints, therefore all corresponding p-values provided are of an exploratory nature.|ANCOVA|||||1.196|0.639|0.3951
72481559|NCT02382016|144489865|SUPERIORITY||Least squares (LS) mean difference|1.67||||0.0637|TWO_SIDED|95.0|-0.1|3.44||No adjustment was made for multiplicity for secondary endpoints, therefore all corresponding p-values provided are of an exploratory nature.|ANCOVA||The estimated value refers to a between-treatment analysis of change from baseline to Week 12 in mRAP (LS mean difference macitentan 10 mg - placebo).|||3.44|-0.10|0.0637
72481560|NCT02382016|144489866|SUPERIORITY||Least squares (LS) mean difference|-5.99||||0.0001|TWO_SIDED|95.0|-8.4|-3.57||No adjustment was made for multiplicity for secondary endpoints, therefore all corresponding p-values provided are of an exploratory nature.|ANCOVA||The estimated value refers to a between-treatment analysis of change from baseline to Week 12 in mPAP (LS mean difference macitentan 10 mg - placebo).|||-3.57|-8.40|0.0001
72481561|NCT02382016|144489867|SUPERIORITY||Least squares (LS) mean difference|0.52||||0.0009|TWO_SIDED|95.0|0.22|0.81||No adjustment was made for multiplicity for secondary endpoints, therefore all corresponding p-values provided are of an exploratory nature.|ANCOVA||The estimated value refers to a between-treatment analysis of change from baseline to Week 12 in cardiac index (LS mean difference macitentan 10 mg - placebo).|||0.81|0.22|0.0009
72481562|NCT02382016|144489868|SUPERIORITY||Least squares (LS) mean difference|-171.48||||0.0001|TWO_SIDED|95.0|-223.67|-119.3||No adjustment was made for multiplicity for secondary endpoints, therefore all corresponding p-values provided are of an exploratory nature.|ANCOVA||The estimated value refers to a between-treatment analysis of change from baseline to Week 12 in TPR (LS mean difference macitentan 10 mg - placebo).|||-119.30|-223.67|0.0001
72481563|NCT02382016|144489869|SUPERIORITY||Least squares (LS) mean difference|0.03||||0.9844|TWO_SIDED|95.0|-2.85|2.91||No adjustment was made for multiplicity for secondary endpoints, therefore all corresponding p-values provided are of an exploratory nature.|ANCOVA||The estimated value refers to a between-treatment analysis of change from baseline to Week 12 in SVO2 (LS mean difference macitentan 10 mg - placebo).|||2.91|-2.85|0.9844
72481564|NCT00084266|144489870|NON_INFERIORITY_OR_EQUIVALENCE|The final p-value was compared against an O'Brien-Fleming boundary of 0.048.||||||0.042|TWO_SIDED||||||Chi-squared|||"Chi-squared test was used to calculate p-value. P-value was calculated for participants with clinical outcome as cure."||||0.042
72481565|NCT00084266|144489882|SUPERIORITY_OR_OTHER|||||||0.9344|TWO_SIDED||||||Log Rank|||Statistical comparison of survival analysis was performed.Log rank method was used to calculate p-value.||||0.9344
72481566|NCT00084266|144489883|SUPERIORITY_OR_OTHER|||||||0.5985|TWO_SIDED||||||Log Rank|||Statistical comparison of survival analysis was performed.Log rank method was used to calculate p-value.||||0.5985
72481567|NCT00084266|144489884|SUPERIORITY_OR_OTHER|||||||0.859|TWO_SIDED||||||Log Rank|||Statistical comparison of survival analysis was performed.Log rank method was used to calculate p-value.||||0.8590
72481568|NCT02901041|144490020|SUPERIORITY||Mean Difference (Net)|0.02||||0.98|TWO_SIDED|95.0|-1.41|1.45|||t-test, 2 sided|t=0.03, df=79.00||A t-test was used to compare means between conditions at baseline (pre-treatment). The null hypothesis was that the difference in group means is zero.||1.45|-1.41|.98
72510345|NCT04184622|144551053|SUPERIORITY||LS Mean Difference (Net)|-17.7|||<|0.0001|TWO_SIDED|95.0|-19.8|-15.7|||Mixed Models Analysis|||||-15.7|-19.8|<.0001
72510346|NCT04184622|144551053|SUPERIORITY||LS Mean Difference (Net)|-20.7|||<|0.0001|TWO_SIDED|95.0|-22.8|-18.6|||Mixed Models Analysis|||||-18.6|-22.8|<.0001
72510347|NCT04184622|144551054|SUPERIORITY||Hazard Ratio (HR)|0.06|||<|0.0001|TWO_SIDED|95.0|0.03|0.13|||Regression, Cox|||||0.13|0.03|<0.0001
72510348|NCT04184622|144551055|SUPERIORITY||Hazard Ratio (HR)|0.12|||<|0.0001|TWO_SIDED|95.0|0.07|0.21|||Regression, Cox|||||0.21|0.07|<0.0001
72401890|NCT02120950|144311062|SUPERIORITY_OR_OTHER_LEGACY||treatment difference in %|1.7||||0.5372|TWO_SIDED|95.0|-3.7|7.2|||Cochran-Mantel-Haenszel|The p-value is calculated from the 2-sided Cochran-Mantel-Haenszel test adjusted by ethnicity and qualification for rescue therapy at Week 12|CI is based on the treatment difference in % (AFL-sham - AFL-PDT) using the Mantel-Haenszel weighting scheme adjusted by ethnicity and qualification for rescue therapy at Week 12|Category of Lost ≥ 5||7.2|-3.7|0.5372
72481569|NCT02901041|144490021|SUPERIORITY||Mean Difference (Net)|-0.83||||0.13|TWO_SIDED|95.0|-1.92|0.26|||t-test, 2 sided|t=-1.52, df=56.00||A t-test was used to compare means between conditions at baseline post-treatment. The null hypothesis was that the difference in group means is zero.||0.26|-1.92|.13
72481570|NCT02901041|144490022|SUPERIORITY||Mean Difference (Net)|-0.07||||0.19|TWO_SIDED|95.0|-0.17|0.03||Equality of variance was not assumed.|t-test, 2 sided|t=-1.33, df=72.65||A t-test was used to compare means between conditions at baseline (pre-treatment). The null hypothesis was that the difference in group means is zero.||0.03|-0.17|.19
72510349|NCT04184622|144551056|SUPERIORITY||LS Mean Difference (Net)|-5.1|||<|0.001|TWO_SIDED|95.0|-5.5|-4.6|||Mixed Models Analysis|||||-4.6|-5.5|<0.001
72510350|NCT04184622|144551056|SUPERIORITY||LS Mean Difference (Net)|-7.2|||<|0.001|TWO_SIDED|95.0|-7.7|-6.8|||Mixed Models Analysis|||||-6.8|-7.7|<0.001
72510351|NCT04184622|144551056|SUPERIORITY||LS Mean Difference (Net)|-7.7|||<|0.001|TWO_SIDED|95.0|-8.2|-7.3|||Mixed Models Analysis|||||-7.3|-8.2|<0.001
72510352|NCT04184622|144551057|SUPERIORITY||LS Mean Difference (Net)|-0.33|||<|0.001|TWO_SIDED|95.0|-0.36|-0.3|||Mixed Models Analysis|||||-0.30|-0.36|<0.001
72510353|NCT04184622|144551057|SUPERIORITY||LS Mean Difference (Net)|-0.42|||<|0.001|TWO_SIDED|95.0|-0.45|-0.38|||Mixed Models Analysis|||||-0.38|-0.45|<0.001
72481571|NCT02901041|144490023|SUPERIORITY||Mean Difference (Net)|-0.17||||0.05|TWO_SIDED|95.0|-0.34|0.0|||t-test, 2 sided|t=-1.99, df=56.00||||0.00|-0.34|.05
72510354|NCT04184622|144551057|SUPERIORITY||LS Mean Difference (Net)|-0.44|||<|0.001|TWO_SIDED|95.0|-0.48|-0.41|||Mixed Models Analysis|||||-0.41|-0.48|<0.001
72401891|NCT02120950|144311062|SUPERIORITY_OR_OTHER_LEGACY||treatment difference in %|0.6||||0.7569|TWO_SIDED|95.0|-3.4|4.7|||Cochran-Mantel-Haenszel|The p-value is calculated from the 2-sided Cochran-Mantel-Haenszel test adjusted by ethnicity and qualification for rescue therapy at Week 12|CI is based on the treatment difference in % (AFL-sham - AFL-PDT) using the Mantel-Haenszel weighting scheme adjusted by ethnicity and qualification for rescue therapy at Week 12|Category of Lost ≥ 10||4.7|-3.4|0.7569
72401892|NCT02120950|144311062|SUPERIORITY_OR_OTHER_LEGACY||treatment difference in %|-0.6||||0.7402|TWO_SIDED|95.0|-4.3|3.1|||Cochran-Mantel-Haenszel|The p-value is calculated from the 2-sided Cochran-Mantel-Haenszel test adjusted by ethnicity and qualification for rescue therapy at Week 12|CI is based on the treatment difference in % (AFL-sham - AFL-PDT) using the Mantel-Haenszel weighting scheme adjusted by ethnicity and qualification for rescue therapy at Week 12|Category of Lost ≥ 15||3.1|-4.3|0.7402
72401893|NCT02120950|144311063|SUPERIORITY_OR_OTHER_LEGACY||treatment difference in %|-6.0||||0.3244|TWO_SIDED|95.0|-17.8|5.9|||Cochran-Mantel-Haenszel|The p-value is calculated from the 2-sided Cochran-Mantel-Haenszel test adjusted by ethnicity and qualification for rescue therapy at Week 12|CI is based on the treatment difference in % (AFL-sham - AFL-PDT) using the Mantel-Haenszel weighting scheme adjusted by ethnicity and qualification for rescue therapy at Week 12|||5.9|-17.8|0.3244
72401894|NCT02120950|144311064|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.1||||0.7109|TWO_SIDED|95.0|-0.9|0.6|||ANCOVA||Point estimate, 95% CI and p-value are based on difference (AFL-sham - AFL-PDT) of LS mean changes using an ANCOVA model with treatment group and ethnicity and qualification for rescue therapy at Week 12 as fixed effects, baseline value as covariate.|The analysis population included only subjects with leakage in FA at baseline and Week 52. Baseline values were not carried forward.||0.6|-0.9|0.7109
72401895|NCT02120950|144311065|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.1||||0.8355|TWO_SIDED|95.0|-9.2|11.3|||ANCOVA||Point estimate, 95% CI and p-value are based on difference (AFL-sham - AFL-PDT) of LS mean changes using an ANCOVA model with treatment group and ethnicity and qualification for rescue therapy at Week 12 as fixed effects, baseline value as covariate.|The analysis population included only subjects with values for CST at baseline and Week 52. Baseline values were not carried forward.||11.3|-9.2|0.8355
72401896|NCT02120950|144311066|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.7||||0.5069|TWO_SIDED|95.0|-2.9|1.4|||ANCOVA||Point estimate, 95% CI and p-value are based on difference (AFL-sham - AFL-PDT) of LS mean changes using an ANCOVA model with treatment group and ethnicity and qualification for rescue therapy at Week 12 as fixed effects, baseline value as covariate.|The analysis population included only subjects with values for NEI VFQ-25 score at baseline and Week 52.||1.4|-2.9|0.5069
72401897|NCT02120950|144311067|SUPERIORITY_OR_OTHER_LEGACY||Difference %|-0.6||||0.8423|TWO_SIDED|95.0|-6.3|5.1||The p-value is calculated from the 2-sided Cochran-Mantel-Haenszel test adjusted by ethnicity and qualification for rescue therapy at Week 12.|Cochran-Mantel-Haenszel||CI is based on the treatment difference in % (AFL-sham - AFL-PDT) using the Mantel-Haenszel weighting scheme adjusted by ethnicity and qualification for rescue therapy at Week 12.|||5.1|-6.3|0.8423
72401898|NCT02424383|144311068|OTHER||||||||||||||||||Freedom from Target LesionRevascularization (TLR) were reported through 12 months with frequency counts, percentages and 95% confidence intervals from exact binomial test. In addition, Kaplan-Meier tables and curves were created.|||
72401899|NCT02424383|144311069|OTHER||||||||||||||||||Freedom from composite of safety events from the time following the index procedure through 30 days post procedure were reported with frequency counts, percentages and 95% confidence intervals from exact binomial test. Kaplan-Meier tables and curves were also calculated.|||
72401900|NCT00117559|144311076|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||ANOVA|||||||<.05
72401901|NCT02738333|144311081|NON_INFERIORITY|A sample size of 100 participants per treatment group would provide over 90% power to establish non-inferiority in the SVR12 rates between the LDV/SOF group and SOF+RBV group. Sample size was based on the assumptions that the clinically meaningful non-inferiority margin is 10%, both groups have a SVR12 rate of 96%, and the significance level is 0.025 one-sided.|Difference in proportions|0.9|||||TWO_SIDED|95.0|-5.3|7.1|||||Difference in proportions between treatment groups and associated 95% confidence intervals (CI) are calculated based on stratum-adjusted Mantel-Haenszel proportions.|||7.1|-5.3|
72566822|NCT02312713|144664440|NON_INFERIORITY|Since there were not sufficient data in prior literature to specific an a priori non-inferiority margin, for this and other secondary outcomes we based conclusions and discussions on magnitude of differences between the group, descriptively. This strategy was specified in the protocol.|Mean Difference (Final Values)|-0.24||||0.63|TWO_SIDED|95.0|-1.23|0.74|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Internet Based Exercise Training at 4 months for Timed Up and Go.||0.74|-1.23|0.63
72401902|NCT00791518|144311107|SUPERIORITY_OR_OTHER||Least squares mean difference|0.2||||||95.0|0.1|0.4|||||Least squares mean differences are calculated as \<80% group minus \>=80% group and are adjusted for Investigator.|||0.4|0.1|
72401903|NCT00791518|144311108|SUPERIORITY_OR_OTHER||Least squares mean difference|0.3||||||95.0|0.2|0.4|||||Least squares mean differences are calculated as \<50% group minus \>=50% group and was adjusted for Investigator.|||0.4|0.2|
72401904|NCT00791518|144311113|SUPERIORITY_OR_OTHER||Least squares mean difference|0.7||||||95.0|-0.4|1.7|||||Least squares mean differences are calculated as \<80% group minus \>=80% group and was adjusted for Investigator.|||1.7|-0.4|
72401905|NCT00791518|144311114|SUPERIORITY_OR_OTHER||Least squares mean difference|0.9||||||95.0|-0.2|2.1|||||Least squares mean differences are calculated as \<50% group minus \>=50% group and was adjusted for Investigator.|||2.1|-0.2|
72401906|NCT01748643|144311116|SUPERIORITY|||||||0.16|||||||Wilcoxon (Mann-Whitney)|||||||0.16
72401907|NCT01748643|144311117|SUPERIORITY|||||||0.69|||||||Wilcoxon (Mann-Whitney)|||||||0.69
72401908|NCT01748643|144311118|SUPERIORITY|||||||0.07|||||||Wilcoxon (Mann-Whitney)|||||||0.07
72401909|NCT01748643|144311119|SUPERIORITY|||||||0.97|||||||t-test, 1 sided|||||||0.97
72566823|NCT02312713|144664440|NON_INFERIORITY|Since there were not sufficient data in prior literature to specific an a priori non-inferiority margin, for this and other secondary outcomes we based conclusions and discussions on magnitude of differences between the group, descriptively. This strategy was specified in the protocol.|Mean Difference (Final Values)|-0.72||||0.21|TWO_SIDED|95.0|-1.85|0.41|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Internet Based Exercise Training at 12 months for Timed Up and Go.||0.41|-1.85|0.21
72481572|NCT02901041|144490024|SUPERIORITY||Mean Difference (Net)|0.03||||0.71|TWO_SIDED|95.0|-0.11|0.17|||t-test, 2 sided|t=0.37,df=79.00||A t-test was used to compare means between conditions at baseline (pre-treatment). The null hypothesis was that the difference in group means is zero.||0.17|-0.11|.71
72481573|NCT02901041|144490025|SUPERIORITY||Mean Difference (Net)|-0.11||||0.12|TWO_SIDED|95.0|-0.26|0.03|||t-test, 2 sided|t=-1.59,df=56.00||A t-test was used to compare means between conditions at baseline post-treatment. The null hypothesis was that the difference in group means is zero.||0.03|-0.26|.12
72481574|NCT02901041|144490026|SUPERIORITY||Mean Difference (Net)|0.14||||0.98|TWO_SIDED|95.0|-9.89|10.18|||t-test, 2 sided|t=0.03, df=79.00||||10.18|-9.89|.98
72481575|NCT02901041|144490027|SUPERIORITY||Mean Difference (Net)|-5.8||||0.13|TWO_SIDED|95.0|-13.43|1.83|||t-test, 2 sided|t=-1.52, df=56.00||||1.83|-13.43|.13
72481576|NCT02901041|144490028|SUPERIORITY||Mean Difference (Net)|27.07||||0.75|TWO_SIDED|95.0|-144.06|198.2|||t-test, 2 sided|t=0.32,df=61.00||||198.20|-144.06|.75
72481577|NCT02901041|144490029|SUPERIORITY||Mean Difference (Net)|99.05||||0.35|TWO_SIDED|95.0|-111.11|309.21|||t-test, 2 sided|t=0.95, df=46.00||||309.21|-111.11|.35
72481578|NCT02901041|144490030|SUPERIORITY||Mean Difference (Net)|0.85||||0.51|TWO_SIDED|95.0|-1.69|3.4|||t-test, 2 sided|t=0.67, df=58.00||A t-test was used to compare means between conditions at baseline (pre-treatment). The null hypothesis was that the difference in group means is zero.||3.40|-1.69|.51
72481579|NCT02901041|144490031|SUPERIORITY||Mean Difference (Net)|-0.42||||0.55|TWO_SIDED|95.0|-1.82|0.98|||t-test, 2 sided|t=-0.61,df=36||A t-test was used to compare means between conditions at baseline post-treatment. The null hypothesis was that the difference in group means is zero.||0.98|-1.82|.55
72481580|NCT02901041|144490032|SUPERIORITY||Mean Difference (Net)|0.15||||0.95|TWO_SIDED|95.0|-4.15|4.45|||t-test, 2 sided|t=0.07,df=58.00||A t-test was used to compare means between conditions at baseline (pre-treatment). The null hypothesis was that the difference in group means is zero.||4.45|-4.15|.95
72481581|NCT02901041|144490033|SUPERIORITY||Mean Difference (Net)|3.34||||0.42|TWO_SIDED|95.0|-4.93|11.62|||t-test, 2 sided|t=0.82, df=38.00||A t-test was used to compare means between conditions at baseline post-treatment. The null hypothesis was that the difference in group means is zero.||11.62|-4.93|.42
72481582|NCT02901041|144490034|SUPERIORITY||Mean Difference (Net)|0.32||||0.17|TWO_SIDED|95.0|-0.15|0.8||Equal variance was not assumed.|t-test, 2 sided|t=1.39, df=36.37||A t-test was used to compare means between conditions at baseline (pre-treatment). The null hypothesis was that the difference in group means is zero.||0.80|-0.15|.17
72481583|NCT02901041|144490035|SUPERIORITY||Mean Difference (Net)|0.41||||0.14|TWO_SIDED|95.0|-0.14|0.97||Equal variances were not assumed when conducting the t-test.|t-test, 2 sided|t=1.53, df=24.05||A t-test was used to compare means between conditions at baseline post-treatment. The null hypothesis was that the difference in group means is zero.||0.97|-0.14|0.14
72481584|NCT02901041|144490036|SUPERIORITY||Mean Difference (Net)|3.07||||0.14|TWO_SIDED|95.0|-1.03|7.16||Equal variances were not assumed when conducting the t-tests.|t-test, 2 sided|t=1.51,df=39.34||A t-test was used to compare means between conditions at baseline (pre-treatment). The null hypothesis was that the difference in group means is zero.||7.16|-1.03|.14
72481585|NCT02901041|144490037|SUPERIORITY||Mean Difference (Net)|3.18||||0.4|TWO_SIDED|95.0|-4.39|10.75||Equality of variance was not assumed.|t-test, 2 sided|t=0.85, df=39.00||A t-test was used to compare means between conditions at baseline post-treatment. The null hypothesis was that the difference in group means is zero.||10.75|-4.39|.40
72481586|NCT02901041|144490038|SUPERIORITY||Mean Difference (Net)|0.4||||0.06|TWO_SIDED|95.0|-0.01|0.81||Equal variances were not assumed when conducting the t-test.|t-test, 2 sided|t=1.97, df=38.37||A t-test was used to compare means between conditions at baseline (pre-treatment). The null hypothesis was that the difference in group means is zero.||0.81|-0.01|.06
72481587|NCT02901041|144490039|SUPERIORITY||Mean Difference (Net)|0.03||||0.96|TWO_SIDED|95.0|-1.0|1.05|||t-test, 2 sided|t=.06, df=39.00||A t-test was used to compare means between conditions at baseline post-treatment. The null hypothesis was that the difference in group means is zero.||1.05|-1.00|.96
72481588|NCT02901041|144490040|SUPERIORITY||Mean Difference (Net)|2.03||||0.6|TWO_SIDED|95.0|-5.58|9.64|||t-test, 2 sided|t=0.53,df=57.00||A t-test was used to compare means between conditions at baseline (pre-treatment). The null hypothesis was that the difference in group means is zero.||9.64|-5.58|.60
72401910|NCT01748643|144311120|SUPERIORITY|||||||0.64|||||||t-test, 1 sided|||||||0.64
72401911|NCT01748643|144311121|SUPERIORITY|||||||0.58|||||||t-test, 1 sided|||||||0.58
72401912|NCT02009046|144311190|SUPERIORITY||Odds Ratio (OR)|1.09||||0.643|TWO_SIDED|95.0|0.75|1.6|||Regression, Logistic|Multilevel model to account for classroom/school clusters. Adjusted for student/classroom gender, student/classroom sexual experience, pretest score.||||1.60|0.75|0.6430
72401913|NCT02009046|144311190|SUPERIORITY||Odds Ratio (OR)|0.75||||0.3718|TWO_SIDED|95.0|0.39|1.44|||Regression, Logistic|Multilevel model to account for classroom/school clusters. Adjusted for student/classroom gender, student/classroom sexual experience, pretest score.||||1.44|0.39|0.3718
72481589|NCT02901041|144490041|SUPERIORITY||Mean Difference (Net)|-0.06||||0.21|TWO_SIDED|95.0|-0.15|0.03|||t-test, 2 sided|t=-1.27, df=39.00||A t-test was used to compare means between conditions at baseline post-treatment. The null hypothesis was that the difference in group means is zero.||0.03|-0.15|.21
72481590|NCT02901041|144490042|SUPERIORITY||Mean Difference (Net)|-0.28||||0.09|TWO_SIDED|95.0|-0.6|0.04|||t-test, 2 sided|t=-1.74,df=57.00||A t-test was used to compare means between conditions at baseline (pre-treatment). The null hypothesis was that the difference in group means is zero.||0.04|-0.60|.09
72481591|NCT02901041|144490043|SUPERIORITY||Mean Difference (Net)|-0.35||||0.1|TWO_SIDED|95.0|-0.78|0.07|||t-test, 2 sided|t=-1.69, df=39.00||A t-test was used to compare means between conditions at baseline post-treatment. The null hypothesis was that the difference in group means is zero.||0.07|-0.78|.10
72481592|NCT02901041|144490044|SUPERIORITY||Mean Difference (Net)|0.02||||0.8|TWO_SIDED|95.0|-0.15|0.19|||t-test, 2 sided|t=0.25,df=57.00||A t-test was used to compare means between conditions at baseline (pre-treatment). The null hypothesis was that the difference in group means is zero.||0.19|-0.15|0.80
72481593|NCT02901041|144490045|SUPERIORITY||Mean Difference (Net)|-5.61||||0.41|TWO_SIDED|95.0|-14.56|3.34|||t-test, 2 sided|t=-0.84,df=39.00||A t-test was used to compare means between conditions at baseline post-treatment. The null hypothesis was that the difference in group means is zero.||3.34|-14.56|.41
72623982|NCT02231580|144778416|SUPERIORITY_OR_OTHER||GLS mean ratio|1.16|||=|0.5338|TWO_SIDED|90.0|0.781|1.724|||MMRM|||Right hand grip force variability statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||1.724|0.781|=0.5338
72510355|NCT04184622|144551058|SUPERIORITY||LS Mean Difference (Net)|-8.59|||<|0.001|TWO_SIDED|95.0|-9.97|-7.2|||Mixed Models Analysis|||||-7.20|-9.97|<0.001
72510356|NCT04184622|144551058|SUPERIORITY||LS Mean Difference (Net)|-10.59|||<|0.001|TWO_SIDED|95.0|-11.98|-9.21|||Mixed Models Analysis|||||-9.21|-11.98|<0.001
72510357|NCT04184622|144551058|SUPERIORITY||LS Mean Difference (Net)|-11.42|||<|0.001|TWO_SIDED|95.0|-12.8|-10.3|||Mixed Models Analysis|||||-10.30|-12.80|<0.001
72510358|NCT04184622|144551059|SUPERIORITY||Estimate Difference|-6.06|||<|0.001|TWO_SIDED|95.0|-8.32|-3.75|||Mixed Models Analysis|||||-3.75|-8.32|<0.001
72510359|NCT04184622|144551060|SUPERIORITY||Estimate Difference|-23.3|||<|0.001|TWO_SIDED|95.0|-26.1|-20.4|||Mixed Models Analysis|||||-20.4|-26.1|<0.001
72510360|NCT04184622|144551061|SUPERIORITY||Estimate Difference|-11.3|||<|0.001|TWO_SIDED|95.0|-16.1|-6.2|||Mixed Models Analysis|||||-6.2|-16.1|<0.001
72510361|NCT04184622|144551062|SUPERIORITY||LS Mean Difference (Net)|-4.2|||<|0.001|TWO_SIDED|95.0|-5.0|-3.5|||Mixed Models Analysis|||||-3.5|-5.0|<0.001
72510362|NCT04184622|144551063|SUPERIORITY||Odds Ratio (OR)|29.79|||<|0.0001|TWO_SIDED|95.0|17.73|50.05|||Regression, Logistic|||||50.05|17.73|<.0001
72510363|NCT04184622|144551063|SUPERIORITY||Odds Ratio (OR)|35.05|||<|0.0001|TWO_SIDED|95.0|20.63|59.53|||Regression, Logistic|||||59.53|20.63|<.0001
72510364|NCT04184622|144551063|SUPERIORITY||Odds Ratio (OR)|55.05|||<|0.0001|TWO_SIDED|95.0|29.61|102.34|||Regression, Logistic|||||102.34|29.61|<.0001
72510365|NCT04184622|144551064|SUPERIORITY||LS Mean Difference (Net)|7.7|||<|0.001|TWO_SIDED|95.0|5.6|9.8|||ANCOVA|||||9.8|5.6|<0.001
72510366|NCT04184622|144551064|SUPERIORITY||LS Mean Difference (Net)|10.7|||<|0.001|TWO_SIDED|95.0|8.6|12.8|||ANCOVA|||||12.8|8.6|<0.001
72510367|NCT04184622|144551064|SUPERIORITY||LS Mean Difference (Net)|11.7|||<|0.001|TWO_SIDED|95.0|9.6|13.8|||ANCOVA|||||13.8|9.6|<0.001
72510368|NCT00769704|144551066|SUPERIORITY_OR_OTHER||Treatment Difference|14.1|||<|0.0001|TWO_SIDED|95.0|9.3|19.0|||Fisher Exact|||The null hypothesis was that there was no difference in the durable response rate between the talimogene laherparepvec and control arms. Study success was defined as the rejection of this hypothesis such that talimogene laherparepvec was found to be superior to GM-CSF using the 2-sided Fisher's exact test, with a p-value of ≤ 0.0488.||19.0|9.3|<0.0001
72510369|NCT00769704|144551067|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.79||||0.0511|TWO_SIDED|95.0|0.62|1.0|||Log Rank||The hazard ratio was obtained from the unadjusted Cox Proportional Hazard Model. A hazard ratio \< 1.0 indicates a lower average death rate and a longer overall survival for talimogene laherparepvec relative to GM-CSF.|The primary method for analysis of overall survival was an unadjusted log-rank test. Testing of overall survival was conditional on a statistically significance difference in the primary endpoint of durable response. Success was defined as a p-value ≤ 0.05.||1.00|0.62|0.0511
72510370|NCT00769704|144551068|SUPERIORITY_OR_OTHER||Treatment Difference|20.8|||<|0.0001|TWO_SIDED|95.0|14.4|27.1||Descriptive|Fisher Exact|||||27.1|14.4|<0.0001
72510371|NCT00769704|144551069|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.4||||0.0868|TWO_SIDED|95.0|0.14|1.18||Descriptive|Log Rank||The hazard ratio was obtained from the unadjusted Cox Proportional Hazard Model. A hazard ratio \< 1.0 indicates a longer average duration of response for talimogene laherparepvec relative to GM-CSF.|||1.18|0.14|0.0868
72510372|NCT00769704|144551070|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.62||||0.202|TWO_SIDED|95.0|0.3|1.3||Descriptive|Log Rank||The hazard ratio was obtained from the unadjusted Cox Proportional Hazard Model. A hazard ratio \> 1.0 indicates a a higher average response onset rate for talimogene laherparepvec relative to GM-CSF.|||1.30|0.30|0.2020
72510373|NCT00769704|144551071|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.42|||<|0.0001|TWO_SIDED|95.0|0.32|0.54||Descriptive|Log Rank||The hazard ratio was obtained from the unadjusted Cox Proportional Hazard Model. A hazard ratio \< 1.0 indicates a longer average time to treatment failure for talimogene laherparepvec relative to GM-CSF.|||0.54|0.32|<0.0001
72510374|NCT00769704|144551072|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.3||||0.005|TWO_SIDED|95.0|0.13|0.73||Descriptive|Log Rank||The hazard ratio was obtained from the unadjusted Cox Proportional Hazard Model. A hazard ratio \< 1.0 indicates a longer response interval for talimogene laherparepvec relative to GM-CSF.|||0.73|0.13|0.0050
72510375|NCT01617681|144551078|OTHER||Mean Difference (Net)|-7.9|STANDARD_ERROR_OF_MEAN|2.96||0.0096|TWO_SIDED|95.0|-13.86|-2.01|||ANCOVA|||||-2.01|-13.86|0.0096
72510376|NCT01617681|144551078|OTHER||Mean Difference (Net)|-0.9|STANDARD_ERROR_OF_MEAN|2.07||0.6531|TWO_SIDED|95.0|-5.07|3.2|||ANCOVA|||||3.20|-5.07|0.6531
72510377|NCT01617681|144551079|OTHER||Mean Difference (Net)|-7.9|STANDARD_ERROR_OF_MEAN|2.54||0.003|TWO_SIDED|95.0|-12.94|-2.78|||ANCOVA|||||-2.78|-12.94|0.0030
72510378|NCT01617681|144551079|OTHER||Mean Difference (Net)|-5.4|STANDARD_ERROR_OF_MEAN|1.8||0.0042|TWO_SIDED|95.0|-8.98|-1.77|||ANCOVA|||||-1.77|-8.98|0.0042
72510379|NCT01617681|144551080|OTHER||Odds Ratio (OR)|1.68||||0.411|TWO_SIDED|95.0|0.49|5.8|||ANCOVA|||||5.8|0.49|0.411
72510380|NCT01617681|144551080|OTHER||Odds Ratio (OR)|1.45||||0.5443|TWO_SIDED|95.0|0.44|4.79|||ANCOVA|||||4.79|0.44|0.5443
72510381|NCT01617681|144551081|OTHER||Odds Ratio (OR)|0.517||||0.2624|TWO_SIDED|95.0|0.16|1.64|||ANCOVA|||||1.64|0.16|0.2624
72510382|NCT03696758|144551082|OTHER|Descriptive statistics||||||0.004||||||p value is 0.004 for 'Pre-Metoprolol' vs 'post-Metoprolol' subgroup|Wilcoxon Signed Rank Test|||||||0.004
72510383|NCT03696758|144551083|OTHER|Descriptive statistics||||||0.13||||||P-Value is 0.13 for 'Pre-Sildenafil' vs 'Post-Sildenafil' subgroup|Wilcoxon Signed Rank Test|||||||0.13
72510384|NCT03696758|144551084|OTHER|descriptive statistics||||||0.004||||||p value is 0.004 for 'Pre-Metoprolol' vs 'post-Metoprolol' subgroup|Wilcoxon Signed Rank Test|||||||0.004
72510385|NCT03696758|144551085|OTHER|Descriptive statistics||||||0.1||||||p value is 0.10 for 'Pre-Metoprolol' vs 'post-Metoprolol' subgroup|Wilcoxon Signed Rank Test|||||||0.1
72510386|NCT03696758|144551086|OTHER|Descriptive statistics||||||0.09||||||p value is 0.09 for 'Pre-Metoprolol' vs 'post-Metoprolol' subgroup|Wilcoxon Signed Rank Test|||||||0.09
72510387|NCT03696758|144551087|OTHER|Descriptive statistics||||||0.1||||||p value is 0.10 for 'Pre-Metoprolol' vs 'post-Metoprolol' subgroup|Wilcoxon Signed Rank Test|||||||0.10
72510388|NCT03696758|144551088|OTHER|Descriptive statistics||||||0.82||||||p value is 0.82 for 'Pre-Metoprolol' vs 'post-Metoprolol' subgroup|Wilcoxon Signed Rank Test|||||||0.82
72510389|NCT03696758|144551089|OTHER|Descriptive statistics||||||0.3||||||p value is 0.30 for 'Pre-Metoprolol' vs 'post-Metoprolol' subgroup|Wilcoxon Signed Rank Test|||||||0.30
72510390|NCT03696758|144551090|OTHER|Descriptive statistics||||||0.36||||||p value is 0.36 for 'Pre-Metoprolol' vs 'post-Metoprolol' subgroup|Wilcoxon Signed Rank Test|||||||0.36
72510391|NCT03696758|144551091|OTHER|Descriptive statistics||||||0.36||||||p value is 0.36 for 'Pre-Metoprolol' vs 'post-Metoprolol' subgroup|Wilcoxon Signed Rank Test|||||||0.36
72510392|NCT03696758|144551092|OTHER|Descriptive statistics||||||0.65||||||P-Value is 0.65 for 'Pre-Metoprolol' vs 'post-Metoprolol' subgroup|Wilcoxon Signed Rank Test|||||||0.65
72510393|NCT03696758|144551093|OTHER|Descriptive statistics||||||0.25||||||P-Value is 0.25 for 'Pre-Sildenafil' vs 'Post-Sildenafil' subgroup|Wilcoxon Signed Rank Test|||||||0.25
72623983|NCT02231580|144778417|SUPERIORITY_OR_OTHER||GLS mean ratio|0.693|||=|0.0864|TWO_SIDED|90.0|0.487|0.985|||MMRM|||Left hand isometric grip forces statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||0.985|0.487|=0.0864
72510394|NCT03696758|144551094|OTHER|Descriptive statistics||||||0.43||||||P-Value is 0.43 for 'Pre-Sildenafil' vs 'Post-Sildenafil' subgroup|Wilcoxon Signed Rank Test|||||||0.43
72510395|NCT03696758|144551095|OTHER|Descriptive statistics||||||0.66||||||P-Value is 0.66 for 'Pre-Sildenafil' vs 'Post-Sildenafil' subgroup|Wilcoxon Signed Rank Test|||||||0.66
72623984|NCT02231580|144778417|SUPERIORITY_OR_OTHER||GLS mean ratio|0.686|||=|0.0399|TWO_SIDED|90.0|0.508|0.925|||MMRM|||Right hand isometric grip forces statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||0.925|0.508|=0.0399
72510396|NCT03696758|144551096|OTHER|Descriptive statistics||||||0.13||||||P-Value is 0.13 for 'Pre-Sildenafil' vs 'Post-Sildenafil' subgroup|Wilcoxon Signed Rank Test|||||||0.13
72510397|NCT03696758|144551097|OTHER|Descriptive statistics||||||0.57||||||P-Value is 0.57 for 'Pre-Sildenafil' vs 'Post-Sildenafil' subgroup|Wilcoxon Signed Rank Test|||||||0.57
72510398|NCT03696758|144551098|OTHER|Descriptive statistics||||||0.25||||||P-Value is 0.25 for 'Pre-Sildenafil' vs 'Post-Sildenafil' subgroup|Wilcoxon Signed Rank Test|||||||0.25
72510399|NCT03696758|144551099|OTHER|Descriptive statistics||||||0.07||||||P-Value is 0.07 for 'Pre-Sildenafil' vs 'Post-Sildenafil' subgroup|Wilcoxon Signed Rank Test|||||||0.07
72510400|NCT03696758|144551100|OTHER|Descriptive statistics||||||0.36||||||P-Value is 0.36 for 'Pre-Sildenafil' vs 'Post-Sildenafil' subgroup|Wilcoxon Signed Rank Test|||||||0.36
72510401|NCT03696758|144551101|OTHER|Descriptive statistics||||||0.91||||||P-Value is 0.91 for 'Pre-Sildenafil' vs 'Post-Sildenafil' subgroup|Wilcoxon Signed Rank Test|||||||0.91
72510402|NCT00458406|144551113|SUPERIORITY_OR_OTHER_LEGACY|||||||0.512||95.0|||||t-test, 2 sided|||"We hypothesized that Bi-Flex would result in improved adherence but similar efficacy to CPAP.~Description of power calculation: The study sample size of 45 in the Bi-Flex group and 15 in the CPAP group had 80% power to detect an effect size ≥ 0.85 with a 0.05 two-sided significance level. In addition, with this sample size, the 95% confidence interval (CI) for the difference between the 2 means had a range of 1.282 standard deviation (SD)."||||0.512
72510403|NCT00458406|144551114|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05||95.0|||||t-test, 2 sided|||"Two-sided t-test. We hypothesized that Bi-Flex would result in improved adherence but similar effi cacy to CPAP.~The study sample size of 45 in the Bi-Flex group and 15 in the CPAP group had 80% power to detect an effect size ≥ 0.85 with a 0.05 two-sided significance level. In addition, with this sample size, the 95% CI for the difference between the 2 means had a range of 1.282 SD."||||>0.05
72510404|NCT00458406|144551115|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05||95.0|||||t-test, 2 sided|||"Two-sided t-test. We hypothesized that Bi-Flex would result in improved adherence but similar effi cacy to CPAP.~The study sample size of 45 in the Bi-Flex group and 15 in the CPAP group had 80% power to detect an effect size ≥ 0.85 with a 0.05 two-sided significance level. In addition, with this sample size, the 95% CI for the difference between the 2 means had a range of 1.282 SD."||||>0.05
72510405|NCT00458406|144551116|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05||95.0|||||Chi-squared|||"Chi-Square test. We hypothesized that Bi-Flex would result in improved adherence but similar efficacy to CPAP.~The study sample size of 45 in the Bi-Flex group and 15 in the CPAP group had 80% power to detect an effect size ≥ 0.85 with a 0.05 two-sided significance level. In addition, with this sample size, the 95% CI for the difference between the 2 means had a range of 1.282 SD."||||>0.05
72510406|NCT00458406|144551117|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05||95.0|||||Wilcoxon (Mann-Whitney)|||Mann-Whitney test. We hypothesized that Bi-Flex would result in improved adherence but similar efficacy to CPAP. The study sample size of 45 in the Bi-Flex group and 15 in the CPAP group had 80% power to detect an effect size ≥ 0.85 with a 0.05 two-sided significance level. In addition, with this sample size, the 95% CI for the difference between the 2 means had a range of 1.282 SD.||||>0.05
72623985|NCT02231580|144778418|SUPERIORITY_OR_OTHER||GLS mean ratio|1.509|||=|0.0574|TWO_SIDED|90.0|1.06|2.15|||MMRM|||Left finger IOI variability statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||2.150|1.060|=0.0574
72481594|NCT01996813|144490053|SUPERIORITY||Odds Ratio (OR)|0.115||||0.0553|TWO_SIDED|95.0|0.002|1.034||The exact p-value was estimated|Regression, Logistic|The method was exact logistic regression||The null hypothesis is that there is no difference in the odds of a cerebral desaturation event between patients wearing versus not wearing thigh-high compression stockings during shoulder arthroscopy in the beach chair position||1.034|0.002|.0553
72481595|NCT01996813|144490054|SUPERIORITY||Mean Difference (Final Values)|40.31|||<|0.001|TWO_SIDED|95.0|20.22|60.39|||t-test, 2 sided|A Satterthwaite correction was used to adjust the degrees of freedom||The null hypothesis is that there is no difference in the average length of surgery between patients wearing versus not wearing thigh-high compression stockings during shoulder arthroscopy in the beach chair position||60.39|20.22|<.001
72481596|NCT01942720|144490059|SUPERIORITY_OR_OTHER||Sperman correlation coeficient|-0.7||||0.631|TWO_SIDED||||||Sperman test|||Relationship of total PillCam SB Lewis score with PGA score change from baseline visit to 6 month follow-up||||0.631
72481597|NCT01942720|144490059|SUPERIORITY_OR_OTHER||Sperman correlation coeficient|0.022||||0.882|TWO_SIDED||||||Sperman correlation|||Relationship of total PillCam SB CECDEIS score with PGA score change from baseline visit to 6 month follow-up||||0.882
72481598|NCT01942720|144490060|SUPERIORITY_OR_OTHER||Sperman correlation coefficient|0.735|||<|0.001|TWO_SIDED||||||Sperman correlation|||Relationship of PillCam SB TI Lewis scores with TI SES-CD score at baseline visit||||<0.001
72510407|NCT00458406|144551117|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05||95.0|||||t-test, 2 sided|||"Two-sided t-test. We hypothesized that Bi-Flex would result in improved adherence but similar efficacy to CPAP.~The study sample size of 45 in the Bi-Flex group and 15 in the CPAP group had 80% power to detect an effect size ≥ 0.85 with a 0.05 two-sided significance level. In addition, with this sample size, the 95% CI for the difference between the 2 means had a range of 1.282 SD."||||<0.05
72510408|NCT00458406|144551119|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05||95.0|||||Wilcoxon (Mann-Whitney)|||"Mann-Whitney test. We hypothesized that Bi-Flex would result in improved adherence but similar efficacy to CPAP.~The study sample size of 45 in the Bi-Flex group and 15 in the CPAP group had 80% power to detect an effect size ≥ 0.85 with a 0.05 two-sided significance level. In addition, with this sample size, the 95% CI for the difference between the 2 means had a range of 1.282 SD."||||>0.05
72481599|NCT01942720|144490060|SUPERIORITY_OR_OTHER||Sperman correlation coefficient|0.726|||<|0.001|TWO_SIDED||||||Sperman correlation|||Relationship of PillCam SB TI CECDEIS scores with TI SES-CD score at baseline visit||||<0.001
72481600|NCT01942720|144490061|SUPERIORITY_OR_OTHER||Sperman correlation coefficient|0.493||||0.002|TWO_SIDED||||||Sperman correlation|||Relationship of PillCam SB Lewis score with TI SES-CD score change from baseline visit to 6 month follow-up||||0.002
72481601|NCT01942720|144490061|SUPERIORITY_OR_OTHER||Sperman correlation coefficient|0.531|||<|0.001|TWO_SIDED||||||Sperman correlation|||Relationship of PillCam SB CECDEIS score with TI SES-CD score change from baseline visit to 6 month follow-up||||<0.001
72510409|NCT00458406|144551120|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05||95.0|||||Wilcoxon (Mann-Whitney)|||"Mann-Whitney test. We hypothesized that Bi-Flex would result in improved adherence but similar efficacy to CPAP.~The study sample size of 45 in the Bi-Flex group and 15 in the CPAP group had 80% power to detect an effect size ≥ 0.85 with a 0.05 two-sided significance level. In addition, with this sample size, the 95% CI for the difference between the 2 means had a range of 1.282 SD."||||>0.05
72510410|NCT01763905|144551124|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-38.06|STANDARD_ERROR_OF_MEAN|2.87|<|0.001|TWO_SIDED|95.0|-43.73|-32.99||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C level and statin use, scheduled visit, and the interaction of treatment with scheduled visit.||The null hypothesis was that there is no mean difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and ezetimibe, and the alternative hypothesis is that a mean difference does exist.||-32.99|-43.73|<0.001
72481602|NCT01942720|144490062|SUPERIORITY_OR_OTHER||Sperman correlation coefficient|0.752|||<|0.001|TWO_SIDED||||||Sperman correlation|||Relationship of PillCam total SB Lewis score change with TI Leis score change from baseline visit to 6 month follow-up||||<0.001
72481603|NCT01942720|144490062|SUPERIORITY_OR_OTHER||Sperman correlation coefficient|0.785|||<|0.001|TWO_SIDED||||||Sperman correlation|||Relationship of PillCam total SB CECDEIS score change with TI Leis score change from baseline visit to 6 month follow-up||||<0.001
72481604|NCT03952806|144490064|SUPERIORITY||Least Square mean difference|0.35|STANDARD_ERROR_OF_MEAN|0.48||0.4656|TWO_SIDED|95.0|-0.6|1.3|||Mixed Models Analysis|||||1.30|-0.60|0.4656
72481605|NCT00655863|144490075|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-307.229|||<|0.001|TWO_SIDED|95.0|-443.168|-171.29||p-value and confidence interval presented without multiplicity adjustment.|ANCOVA|||The null hypothesis that there was no difference between Alogliptin 25 mg QD and placebo groups was tested at a 2-sided 0.05 significance level. The ANCOVA model used for the change in postprandial incremental area the curver for total triglycerides includes treatment and statin use as fixed effects and baseline AUC(0-8h) for total triglycerides as a covariate.||-171.290|-443.168|<0.001
72481606|NCT00655863|144490075|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-253.711|||<|0.001||95.0|-394.161|-113.262||p-value and confidence interval presented without multiplicity adjustment.|ANCOVA|||The null hypothesis that there was no difference between Alogliptin 25 mg QD + Pioglitazone 30 mg QD and placebo QD groups was tested at a 2-sided 0.05 significance level. The ANCOVA model used for the change in postprandial incremental area the curve for total triglycerides includes treatment and statin use as fixed effects and baseline AUC(0-8h) for total triglycerides as a covariate.||-113.262|-394.161|<0.001
72510411|NCT01763905|144551124|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-37.55|STANDARD_ERROR_OF_MEAN|2.33|<|0.001|TWO_SIDED|95.0|-42.16|-32.94||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C level and statin use, scheduled visit, and the interaction of treatment with scheduled visit.||The null hypothesis was that there is no mean difference in the percent change from baseline at Week 12 in LDL-C between evolocumab and ezetimibe, and the alternative hypothesis is that a mean difference does exist.||-32.94|-42.16|<0.001
72510412|NCT01763905|144551125|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-66.3|STANDARD_ERROR_OF_MEAN|5.9|<|0.001|TWO_SIDED|95.0|-77.9|-54.7||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C level and statin use, scheduled visit, and the interaction of treatment with scheduled visit.||||-54.7|-77.9|<0.001
72401914|NCT02009046|144311191|SUPERIORITY||Odds Ratio (OR)|0.96||||0.8083|TWO_SIDED|95.0|0.67|1.37|||Regression, Logistic|Multilevel model to account for classroom/school clusters. Adjusted for student/classroom gender, student/classroom sexual experience, pretest score.||||1.37|0.67|0.8083
72481607|NCT01138007|144490093|SUPERIORITY_OR_OTHER||Least Squared Mean Difference|-0.5||||0.853|TWO_SIDED|95.0|-2.7|1.7||The p-value was estimated based on the ANCOVA model including Baseline MADRS score and region as covariates. The multiplicity was adjusted by Dunnett's step-down procedure.|ANCOVA||The confidence interval was estimated based on the ANCOVA model including Baseline MADRS score and region as covariates.|||1.7|-2.7|0.853
72481608|NCT01138007|144490093|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.0|STANDARD_ERROR_OF_MEAN|1.0||||95.0|||||||In the analysis plan, the second comparison of interest was not to be performed if the first comparison failed to show statistical significance.|||||
72481609|NCT01806129|144490120|SUPERIORITY||Odds Ratio (OR)|2.07|||||TWO_SIDED|90.0|1.29|3.31|||||Odds ratio represents the odds of adopting the appropriate reproductive health management for patients with intervention compared to the odds among patients without intervention. Odds ratio was calculated by GEE analysis.|||3.31|1.29|
72481610|NCT00744523|144490172|SUPERIORITY_OR_OTHER||proportion of the primary endpoint|2.7|STANDARD_ERROR_OF_MEAN|5.0|<|0.05|ONE_SIDED|95.0||5.2|||t-test, 1 sided||"Parameter Dispersion Type of Standard Error of the mean is meant to state that 'mean is the mean of proportions in the sense of a central-limit theorem"|The ARMOUR trial tested the null hypothesis that the MACCE rate was greater than or equal to the Performance Goal (PG) of 13% versus the alternative hypothesis that the true MACCE rate was less than the PG. The sample size was calculated based on 90% power and a Type I error rate of 0.05 (one-sided). The Performance Goal was calculated from results of carotid artery stenting trials that utilized embolic protection devices (EPD).||5.2||<0.05
72481611|NCT03588728|144490232|SUPERIORITY|||||||0.781|||||||ANOVA|P value indicates the interaction term.||Test of between-subjects effects||||.781
72481612|NCT03588728|144490233|SUPERIORITY|||||||0.409|||||||ANOVA|P value indicates the interaction term.||Test of between-subjects effects||||.409
72481613|NCT03588728|144490234|SUPERIORITY|||||||0.697|||||||ANOVA|P value indicates the interaction term.||Test of between-subjects effects||||.697
72481614|NCT03588728|144490235|SUPERIORITY|||||||0.193|||||||ANOVA|P value indicates interaction term.||Test of between subjects effects||||.193
72481615|NCT03588728|144490236|SUPERIORITY|||||||0.185|||||||ANOVA|P value indicates the interaction term||Test of between-subjects effects||||.185
72481616|NCT03588728|144490237|SUPERIORITY|||||||0.198|||||||ANOVA|P value indicates the interaction term||Test of between-measures effects||||.198
72481617|NCT03588728|144490238|SUPERIORITY|||||||0.638|||||||ANOVA|||Test of between-subjects effects||||.638
72510413|NCT01763905|144551125|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-70.6|STANDARD_ERROR_OF_MEAN|5.0|<|0.001|TWO_SIDED|95.0|-80.5|-60.7||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C level and statin use, scheduled visit, and the interaction of treatment with scheduled visit.||||-60.7|-80.5|<0.001
72566824|NCT02312713|144664441|SUPERIORITY||Mean Difference (Final Values)|-0.79||||0.05|TWO_SIDED|95.0|-1.59|0.02|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Wait List Control at 4 months.||0.02|-1.59|0.05
72401915|NCT02009046|144311191|SUPERIORITY||Odds Ratio (OR)|0.6||||0.1083|TWO_SIDED|95.0|0.32|1.13|||Regression, Logistic|Multilevel model to account for classroom/school clusters. Adjusted for student/classroom gender, student/classroom sexual experience, pretest score.||||1.13|0.32|0.1083
72481618|NCT03588728|144490239|SUPERIORITY|||||||0.574|||||||ANOVA|p-value indicates the interaction term||Test of between-subjects effectd||||.574
72481619|NCT03588728|144490240|SUPERIORITY|||||||0.564|||||||ANOVA|P-value indicates the interaction term||Test of between-subjects effects||||.564
72481620|NCT03588728|144490241|SUPERIORITY|||||||0.998|||||||ANOVA|p-value indicates the interaction term||Tests of between-subjects effects||||.998
72481621|NCT03588728|144490242|SUPERIORITY|||||||0.348|||||||ANOVA|P-value indicates the interaction term||Tests of between-subjecs effects||||.348
72481622|NCT01128894|144490262|NON_INFERIORITY_OR_EQUIVALENCE|The p-value was from a 1-sided t test testing whether or not the difference of least square means (albiglutide - liraglutide) was less than or equal to the prespecified noninferiority margin of 0.3%.|Mean Difference (Final Values)|0.21||||0.0846|TWO_SIDED|95.0|0.08|0.34|||ANCOVA|||||0.34|0.08|0.0846
72481623|NCT00195507|144490269|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.53|||<|0.001||95.0|-0.64|-0.43|||ANCOVA|Treatment and center as main effects, and baseline score as a covariant.||||-0.43|-0.64|<0.001
72481624|NCT00195507|144490270|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||||||<0.001
72481625|NCT00195507|144490272|SUPERIORITY_OR_OTHER|||||||0.143|||||||Fisher Exact|||||||0.143
72481626|NCT00973362|144490273|SUPERIORITY_OR_OTHER||Sensitivity (%)|75.0|||||TWO_SIDED|95.0|53.1|88.8||||||||88.8|53.1|
72481627|NCT00973362|144490273|SUPERIORITY_OR_OTHER||Specificity (%)|62.6|||||TWO_SIDED|95.0|59.2|65.9||||||||65.9|59.2|
72481628|NCT00973362|144490273|SUPERIORITY_OR_OTHER||Positive Predictive Value [PPV] (%)|4.8|||||TWO_SIDED|95.0|3.4|5.8||||||||5.8|3.4|
72481629|NCT00973362|144490273|SUPERIORITY_OR_OTHER||Negative Predictive Value [NPV] (%)|99.0|||||TWO_SIDED|95.0|98.1|99.6||||||||99.6|98.1|
72481630|NCT00973362|144490273|SUPERIORITY_OR_OTHER||Prevalence (%)|2.4|||||TWO_SIDED|||||||||||||
72481631|NCT00973362|144490273|SUPERIORITY_OR_OTHER||Relative Risk|4.8|||||TWO_SIDED|95.0|1.8|13.1|||||The relative risk of CIN2+ is defined as the \[ absolute risk of APTIMA HPV (Positive Result) / absolute risk of APTIMA HPV (Negative Result) \] .|||13.1|1.8|
72481632|NCT00973362|144490274|SUPERIORITY_OR_OTHER||Sensitivity (%)|84.2|||||TWO_SIDED|95.0|62.4|94.5||||||||94.5|62.4|
72481633|NCT00973362|144490274|SUPERIORITY_OR_OTHER||Specificity (%)|48.7|||||TWO_SIDED|95.0|45.2|52.2||||||||52.2|45.2|
72481634|NCT00973362|144490274|SUPERIORITY_OR_OTHER||Positive Predictive Value [PPV] (%)|3.8|||||TWO_SIDED|95.0|2.9|4.4||||||||4.4|2.9|
72401916|NCT02009046|144311192|SUPERIORITY||Odds Ratio (OR)|0.62||||0.1006|TWO_SIDED|95.0|0.35|1.1|||Regression, Logistic|Multilevel model to account for classroom/school clusters. Adjusted for student/classroom gender, student/classroom sexual experience, pretest score.||||1.10|0.35|0.1006
72510414|NCT01763905|144551126|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-69.7|STANDARD_ERROR_OF_MEAN|6.2|<|0.001|TWO_SIDED|95.0|-82.0|-57.5||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C level and statin use, scheduled visit, and the interaction of treatment with scheduled visit.||||-57.5|-82.0|<0.001
72510415|NCT01763905|144551126|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-68.8|STANDARD_ERROR_OF_MEAN|5.3|<|0.001|TWO_SIDED|95.0|-79.2|-58.4||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C level and statin use, scheduled visit, and the interaction of treatment with scheduled visit.||||-58.4|-79.2|<0.001
72510416|NCT01763905|144551127|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|43.5|||<|0.001|TWO_SIDED|95.0|30.9|53.4||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Cochran-Mantel Haenszel test stratified by baseline LDL-C and statin use. For testing, non-achievement was imputed for participants with missing data.||||53.4|30.9|<0.001
72510417|NCT01763905|144551127|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|42.0|||<|0.001|TWO_SIDED|95.0|30.3|51.8||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Cochran-Mantel Haenszel test stratified by baseline LDL-C and statin use. For testing, non-achievement was imputed for participants with missing data.||||51.8|30.3|<0.001
72510418|NCT01763905|144551128|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|48.0|||<|0.001|TWO_SIDED|95.0|35.0|57.8||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05|Cochran-Mantel-Haenszel|Cochran-Mantel Haenszel test stratified by baseline LDL-C and statin use. For testing, non-achievement was imputed for participants with missing data.||||57.8|35.0|<0.001
72510419|NCT01763905|144551128|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|37.5|||<|0.001|TWO_SIDED|95.0|25.5|47.5||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05|Cochran-Mantel-Haenszel|Cochran-Mantel Haenszel test stratified by baseline LDL-C and statin use. For testing, non-achievement was imputed for participants with missing data.||||47.5|25.5|<0.001
72510420|NCT01763905|144551129|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-31.53|STANDARD_ERROR_OF_MEAN|2.43|<|0.001|TWO_SIDED|95.0|-36.34|-26.73||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C level and statin use, scheduled visit, and the interaction of treatment with scheduled visit.||||-26.73|-36.34|<0.001
72510421|NCT01763905|144551129|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-34.58|STANDARD_ERROR_OF_MEAN|2.05|<|0.001|TWO_SIDED|95.0|-38.63|-30.54||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C level and statin use, scheduled visit, and the interaction of treatment with scheduled visit.||||-30.54|-38.63|<0.001
72510422|NCT01763905|144551130|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-32.09|STANDARD_ERROR_OF_MEAN|2.63|<|0.001|TWO_SIDED|95.0|-37.28|-26.9||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C level and statin use, scheduled visit, and the interaction of treatment with scheduled visit.||||-26.90|-37.28|<0.001
72510423|NCT01763905|144551130|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-32.99|STANDARD_ERROR_OF_MEAN|2.12|<|0.001|TWO_SIDED|95.0|-37.19|-28.79||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C level and statin use, scheduled visit, and the interaction of treatment with scheduled visit.||||-28.79|-37.19|<0.001
72510424|NCT01763905|144551131|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-32.2|STANDARD_ERROR_OF_MEAN|2.39|<|0.001|TWO_SIDED|95.0|-36.92|-27.49||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C level and statin use, scheduled visit, and the interaction of treatment with scheduled visit.||||-27.49|-36.92|<0.001
72510425|NCT01763905|144551131|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-34.99|STANDARD_ERROR_OF_MEAN|2.33|<|0.001|TWO_SIDED|95.0|-39.59|-30.39||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C level and statin use, scheduled visit, and the interaction of treatment with scheduled visit.||||-30.39|-39.59|<0.001
72510426|NCT01763905|144551132|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-32.86|STANDARD_ERROR_OF_MEAN|2.62|<|0.001|TWO_SIDED|95.0|-38.04|-27.68||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C level and statin use, scheduled visit, and the interaction of treatment with scheduled visit.||||-27.68|-38.04|<0.001
72510427|NCT01763905|144551132|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-33.1|STANDARD_ERROR_OF_MEAN|2.5|<|0.001|TWO_SIDED|95.0|-38.04|-28.17||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C level and statin use, scheduled visit, and the interaction of treatment with scheduled visit.||||-28.17|-38.04|<0.001
72401917|NCT02009046|144311192|SUPERIORITY||Odds Ratio (OR)|0.49||||0.2117|TWO_SIDED|95.0|0.16|1.53|||Regression, Logistic|Multilevel model to account for classroom/school clusters. Adjusted for student/classroom gender, student/classroom sexual experience, pretest score.||||1.53|0.16|0.2117
72401918|NCT02009046|144311193|SUPERIORITY||Odds Ratio (OR)|1.37||||0.0218|TWO_SIDED|95.0|1.05|1.78|||Regression, Logistic|Multilevel model to account for classroom/school clusters. Adjusted for student/classroom gender, student/classroom sexual experience, pretest score.||||1.78|1.05|0.0218
72481635|NCT00973362|144490274|SUPERIORITY_OR_OTHER||Negative Predictive Value [NPV] (%)|99.2|||||TWO_SIDED|95.0|98.1|99.8||||||||99.8|98.1|
72481636|NCT00973362|144490274|SUPERIORITY_OR_OTHER||Prevalence (%)|2.4|||||TWO_SIDED|||||||||||||
72481637|NCT00973362|144490274|SUPERIORITY_OR_OTHER||Relative Risk|4.9|||||TWO_SIDED|95.0|1.4|16.7|||||The relative risk of CIN2+ is defined as the \[ absolute risk of FDA-Approved HPV DNA Assay (Positive Result) / absolute risk of FDA-Approved HPV DNA Assay (Negative Result) \] .|||16.7|1.4|
72481638|NCT00973362|144490275|SUPERIORITY_OR_OTHER||Sensitivity(%)|86.8|||||TWO_SIDED|95.0|78.4|92.3||||||||92.3|78.4|
72481639|NCT00973362|144490275|SUPERIORITY_OR_OTHER||Specificty|62.9|||||TWO_SIDED|95.0|59.6|66.0||||||||66.0|59.6|
72481640|NCT00973362|144490275|SUPERIORITY_OR_OTHER||PPV|20.1|||||TWO_SIDED|95.0|18.1|22.0||||||||22.0|18.1|
72481641|NCT00973362|144490275|SUPERIORITY_OR_OTHER||NPV|97.8|||||TWO_SIDED|95.0|96.5|98.8||||||||98.8|96.5|
72481642|NCT00973362|144490275|SUPERIORITY_OR_OTHER||Prevalence (%)|9.7|||||TWO_SIDED|||||||||||||
72510428|NCT01763905|144551133|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-27.39|STANDARD_ERROR_OF_MEAN|2.39|<|0.001|TWO_SIDED|95.0|-32.11|-22.67||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C level and statin use, scheduled visit, and the interaction of treatment with scheduled visit.||||-22.67|-32.11|<0.001
72510429|NCT01763905|144551133|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-29.94|STANDARD_ERROR_OF_MEAN|2.42|<|0.001|TWO_SIDED|95.0|-34.72|-25.17||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C level and statin use, scheduled visit, and the interaction of treatment with scheduled visit.||||-25.17|-34.72|<0.001
72510430|NCT01763905|144551134|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-26.28|STANDARD_ERROR_OF_MEAN|2.6|<|0.001|TWO_SIDED|95.0|-31.42|-21.15||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C level and statin use, scheduled visit, and the interaction of treatment with scheduled visit.||||-21.15|-31.42|<0.001
72510431|NCT01763905|144551134|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-28.66|STANDARD_ERROR_OF_MEAN|2.64|<|0.001|TWO_SIDED|95.0|-33.88|-23.43||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C level and statin use, scheduled visit, and the interaction of treatment with scheduled visit.||||-23.43|-33.88|<0.001
72510432|NCT01763905|144551135|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-34.86|STANDARD_ERROR_OF_MEAN|2.52|<|0.001|TWO_SIDED|95.0|-39.84|-29.88||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C level and statin use, scheduled visit, and the interaction of treatment with scheduled visit.||||-29.88|-39.84|<0.001
72510433|NCT01763905|144551135|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-36.37|STANDARD_ERROR_OF_MEAN|2.71|<|0.001|TWO_SIDED|95.0|-41.73|-31.01||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C level and statin use, scheduled visit, and the interaction of treatment with scheduled visit.||||-31.01|-41.73|<0.001
72510434|NCT01763905|144551136|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-34.53|STANDARD_ERROR_OF_MEAN|2.79|<|0.001|TWO_SIDED|95.0|-40.05|-29.0||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C level and statin use, scheduled visit, and the interaction of treatment with scheduled visit.||||-29.00|-40.05|<0.001
72481643|NCT00973362|144490276|SUPERIORITY_OR_OTHER||Sensitivity (%)|88.8|||||TWO_SIDED|95.0|80.5|93.8||||||||93.8|80.5|
72481644|NCT00973362|144490276|SUPERIORITY_OR_OTHER||Specificity(%)|55.8|||||TWO_SIDED|95.0|52.3|59.3||||||||59.3|52.3|
72510435|NCT01763905|144551136|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-34.13|STANDARD_ERROR_OF_MEAN|2.91|<|0.001|TWO_SIDED|95.0|-39.87|-28.39||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C level and statin use, scheduled visit, and the interaction of treatment with scheduled visit.||||-28.39|-39.87|<0.001
72481645|NCT00973362|144490276|SUPERIORITY_OR_OTHER||PPV(%)|18.7|||||TWO_SIDED|95.0|17.0|20.4||||||||20.4|17.0|
72481646|NCT00973362|144490276|SUPERIORITY_OR_OTHER||NPV(%)|97.7|||||TWO_SIDED|95.0|96.2|98.8||||||||98.8|96.2|
72481647|NCT00973362|144490276|SUPERIORITY_OR_OTHER||Prevalence(%)|10.3|||||TWO_SIDED|||||||||||||
72481648|NCT04079803|144490295|SUPERIORITY|||||||0.087||||||P value adjusted for multiplicity of 6 co-primary endpoints (p\<0.008 required for significance).|ANCOVA|General Linear Model for the analysis of covariance (ANCOVA) with a two-sided 95% confidence interval and baseline measurement as the covariate.||This primary analysis includes two 100 mg subjects who showed no detectable simufilam in plasma at return visits (their exclusion was not prespecified in the Statistical Analysis Plan).|In a secondary analysis removing two subjects with no detectable simufilam in plasma, P=0.0088 and CFB was 13.4. In percent change from baseline with these two subjects removed, P=0.004.|||0.087
72481649|NCT04079803|144490295|SUPERIORITY|||||||0.01||||||P value adjusted for multiplicity of 6 co-primary endpoints (p\<0.008 required for significance).|ANCOVA|General Linear Model for the analysis of covariance (ANCOVA) with a two-sided 95% confidence interval and baseline measurement as the covariate.||This primary analysis includes one 50 mg subject who showed no detectable simufilam in plasma at return visits (their exclusion was not prespecified in the Statistical Analysis Plan).|In a secondary analysis removing one subject with no detectable simufilam in plasma, P=0.0006 and CFB was 16.9. In percent change from baseline with this subject removed, P=0.0004.|||0.01
72481650|NCT04079803|144490296|SUPERIORITY||||||<|0.0001||||||P value adjusted for multiplicity of 6 co-primary endpoints (p\<0.008 required for significance).|ANCOVA|General Linear Model for the analysis of covariance (ANCOVA) with a two-sided 95% confidence interval and baseline measurement as the covariate.||This primary analysis includes two 100 mg subjects who showed no detectable simufilam in plasma at return visits (their exclusion was not prespecified in the Statistical Analysis Plan).|In a secondary analysis removing two subjects with no detectable simufilam in plasma, P\<0.0001 and CFB was -19.8.|||<0.0001
72401919|NCT02009046|144311193|SUPERIORITY||Odds Ratio (OR)|1.73||||0.0211|TWO_SIDED|95.0|1.09|2.75|||Regression, Logistic|Multilevel model to account for classroom/school clusters. Adjusted for student/classroom gender, student/classroom sexual experience, pretest score.||||2.75|1.09|0.0211
72510436|NCT01763905|144551137|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-23.9|STANDARD_ERROR_OF_MEAN|3.73|<|0.001|TWO_SIDED|95.0|-31.27|-16.54||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C level and statin use, scheduled visit, and the interaction of treatment with scheduled visit.||||-16.54|-31.27|<0.001
72481651|NCT04079803|144490296|SUPERIORITY|||||||0.0012||||||P value adjusted for multiplicity of 6 co-primary endpoints (p\<0.008 required for significance).|ANCOVA|General Linear Model for the analysis of covariance (ANCOVA) with a two-sided 95% confidence interval and baseline measurement as the covariate.||This primary analysis includes one 50 mg subject who showed no detectable simufilam in plasma at return visits (their exclusion was not prespecified in the Statistical Analysis Plan).|In a secondary analysis removing one subject with no detectable simufilam in plasma, P=0.001 and CFB was -14.9.|||0.0012
72510437|NCT01763905|144551137|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-25.26|STANDARD_ERROR_OF_MEAN|4.3|<|0.001|TWO_SIDED|95.0|-33.75|-16.77||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C level and statin use, scheduled visit, and the interaction of treatment with scheduled visit.||||-16.77|-33.75|<0.001
72510438|NCT01763905|144551138|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-25.29|STANDARD_ERROR_OF_MEAN|4.03|<|0.001|TWO_SIDED|95.0|-33.26|-17.33||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C level and statin use, scheduled visit, and the interaction of treatment with scheduled visit.||||-17.33|-33.26|<0.001
72510439|NCT01763905|144551138|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-27.88|STANDARD_ERROR_OF_MEAN|5.73|<|0.001|TWO_SIDED|95.0|-39.21|-16.56||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C level and statin use, scheduled visit, and the interaction of treatment with scheduled visit.||||-16.56|-39.21|<0.001
72510440|NCT01763905|144551139|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-2.59|STANDARD_ERROR_OF_MEAN|4.45||0.97|TWO_SIDED|95.0|-11.38|6.2||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C level and statin use, scheduled visit, and the interaction of treatment with scheduled visit.||||6.20|-11.38|0.97
72510441|NCT01763905|144551139|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-6.42|STANDARD_ERROR_OF_MEAN|5.13||0.33|TWO_SIDED|95.0|-16.55|3.71||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C level and statin use, scheduled visit, and the interaction of treatment with scheduled visit.||||3.71|-16.55|0.33
72510442|NCT01763905|144551140|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|1.58|STANDARD_ERROR_OF_MEAN|4.92||0.97|TWO_SIDED|95.0|-8.14|11.31||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C level and statin use, scheduled visit, and the interaction of treatment with scheduled visit.||||11.31|-8.14|0.97
72510443|NCT01763905|144551140|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-4.69|STANDARD_ERROR_OF_MEAN|6.25||0.33|TWO_SIDED|95.0|-17.04|7.67||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C level and statin use, scheduled visit, and the interaction of treatment with scheduled visit.||||7.67|-17.04|0.33
72510444|NCT01763905|144551141|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|5.15|STANDARD_ERROR_OF_MEAN|2.23||0.068|TWO_SIDED|95.0|0.74|9.56||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C level and statin use, scheduled visit, and the interaction of treatment with scheduled visit.||||9.56|0.74|0.068
72510445|NCT01763905|144551141|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|5.74|STANDARD_ERROR_OF_MEAN|2.28||0.13|TWO_SIDED|95.0|1.23|10.24||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C level and statin use, scheduled visit, and the interaction of treatment with scheduled visit.||||10.24|1.23|0.13
72510446|NCT01763905|144551142|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|3.57|STANDARD_ERROR_OF_MEAN|2.56||0.068|TWO_SIDED|95.0|-1.49|8.63||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C level and statin use, scheduled visit, and the interaction of treatment with scheduled visit.||||8.63|-1.49|0.068
72510447|NCT01763905|144551142|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|4.83|STANDARD_ERROR_OF_MEAN|2.52||0.13|TWO_SIDED|95.0|-0.16|9.81||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C level and statin use, scheduled visit, and the interaction of treatment with scheduled visit.||||9.81|-0.16|0.13
72401920|NCT02009046|144311194|SUPERIORITY||Odds Ratio (OR)|1.25||||0.1763|TWO_SIDED|95.0|0.9|1.73|||Regression, Logistic|Multilevel model to account for classroom/school clusters. Adjusted for student/classroom gender, student/classroom sexual experience, pretest score.||||1.73|0.90|0.1763
72401921|NCT02009046|144311194|SUPERIORITY||Odds Ratio (OR)|0.85||||0.5869|TWO_SIDED|95.0|0.45|1.58|||Regression, Logistic|Multilevel model to account for classroom/school clusters. Adjusted for student/classroom gender, student/classroom sexual experience, pretest score.||||1.58|0.45|0.5869
72401922|NCT02009046|144311195|SUPERIORITY||Odds Ratio (OR)|1.04||||0.8102|TWO_SIDED|95.0|0.75|1.44|||Regression, Logistic|Multilevel model to account for classroom/school clusters. Adjusted for student/classroom gender, student/classroom sexual experience, pretest score.||||1.44|0.75|0.8102
72401923|NCT02009046|144311195|SUPERIORITY||Odds Ratio (OR)|0.72||||0.2956|TWO_SIDED|95.0|0.39|1.34|||Regression, Logistic|Multilevel model to account for classroom/school clusters. Adjusted for student/classroom gender, student/classroom sexual experience, pretest score.||||1.34|0.39|0.2956
72510448|NCT01763905|144551143|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-1.84|STANDARD_ERROR_OF_MEAN|4.35||0.97|TWO_SIDED|95.0|-10.43|6.75||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C level and statin use, scheduled visit, and the interaction of treatment with scheduled visit.||||6.75|-10.43|0.97
72510449|NCT01763905|144551143|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-3.53|STANDARD_ERROR_OF_MEAN|4.85||0.33|TWO_SIDED|95.0|-13.12|6.06||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C level and statin use, scheduled visit, and the interaction of treatment with scheduled visit.||||6.06|-13.12|0.33
72510450|NCT01763905|144551144|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-0.67|STANDARD_ERROR_OF_MEAN|4.7||0.97|TWO_SIDED|95.0|-9.96|8.61||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C level and statin use, scheduled visit, and the interaction of treatment with scheduled visit.||||8.61|-9.96|0.97
72401924|NCT02009046|144311196|SUPERIORITY||Odds Ratio (OR)|1.13||||0.4645|TWO_SIDED|95.0|0.82|1.56|||Regression, Logistic|Multilevel model to account for classroom/school clusters. Adjusted for student/classroom gender, student/classroom sexual experience, pretest score.||||1.56|0.82|0.4645
72401925|NCT02009046|144311196|SUPERIORITY||Odds Ratio (OR)|0.77||||0.3809|TWO_SIDED|95.0|0.43|1.4|||Regression, Logistic|Multilevel model to account for classroom/school clusters. Adjusted for student/classroom gender, student/classroom sexual experience, pretest score.||||1.40|0.43|0.3809
72401926|NCT02009046|144311197|SUPERIORITY||Odds Ratio (OR)|0.75||||0.1335|TWO_SIDED|95.0|0.52|1.09|||Regression, Logistic|Multilevel model to account for classroom/school clusters. Adjusted for student/classroom gender, student/classroom sexual experience, pretest score.||||1.09|0.52|0.1335
72401927|NCT02009046|144311197|SUPERIORITY||Odds Ratio (OR)|0.56||||0.0741|TWO_SIDED|95.0|0.29|1.06|||Regression, Logistic|Multilevel model to account for classroom/school clusters. Adjusted for student/classroom gender, student/classroom sexual experience, pretest score.||||1.06|0.29|0.0741
72510451|NCT01763905|144551144|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|0.08|STANDARD_ERROR_OF_MEAN|5.72||0.33|TWO_SIDED|95.0|-11.24|11.39||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C level and statin use, scheduled visit, and the interaction of treatment with scheduled visit.||||11.39|-11.24|0.33
72510452|NCT01763905|144551145|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-36.9|STANDARD_ERROR_OF_MEAN|2.71|<|0.001|TWO_SIDED|95.0|-42.26|-31.55||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C level and statin use, scheduled visit, and the interaction of treatment with scheduled visit.||The null hypothesis was that there is no mean difference in the percent change from Baseline in the average value of LDL-C at Weeks 10 and 12 between evolocumab and ezetimibe, and the alternative hypothesis is that a mean difference does exist.||-31.55|-42.26|<0.001
72510453|NCT01763905|144551145|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-38.69|STANDARD_ERROR_OF_MEAN|2.21|<|0.001|TWO_SIDED|95.0|-43.06|-34.22||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C level and statin use, scheduled visit, and the interaction of treatment with scheduled visit.||The null hypothesis was that there is no mean difference in the percent change from Baseline in the average value of LDL-C at Weeks 10 and 12 between evolocumab and ezetimibe, and the alternative hypothesis is that a mean difference does exist.||-34.22|-43.06|<0.001
72510454|NCT04346628|144551146|SUPERIORITY||Hazard Ratio (HR)|0.76||||0.24|TWO_SIDED|95.0|0.48|1.2||The final test was performed at the alpha = 0.04999 level of significance, adjusted for age group and sex.|Cox proportional hazards model||Hazard ratio adjusted for age and sex|||1.20|0.48|0.24
72510455|NCT04346628|144551148|SUPERIORITY|||||||0.06||||||A p-value of 0.05 would have been considered statistically significant.|Fisher Exact|||Difference in hospitalizations||||0.06
72510456|NCT04346628|144551148|SUPERIORITY|||||||0.56||||||A p-value of 0.05 would have been considered statistically significant.|Fisher Exact|||Difference in ED visits||||0.56
72401928|NCT02009046|144311198|SUPERIORITY||Odds Ratio (OR)|1.04||||0.9085|TWO_SIDED|95.0|0.54|2.01|||Regression, Logistic|Multilevel model to account for classroom/school clusters. Adjusted for student/classroom gender, student/classroom sexual experience, pretest score.||||2.01|0.54|0.9085
72510457|NCT04346628|144551150|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.43|TWO_SIDED|95.0|0.54|1.29||A p-value of 0.05 would have been considered statistically significant.|Cox proportional hazards model||Hazard ratio adjusted for age and sex|Difference in days until initial resolution of symptoms||1.29|0.54|0.43
72401929|NCT02009046|144311198|SUPERIORITY||Odds Ratio (OR)|1.15||||0.8059|TWO_SIDED|95.0|0.36|3.62|||Regression, Logistic|Multilevel model to account for classroom/school clusters. Adjusted for student/classroom gender, student/classroom sexual experience, pretest score.||||3.62|0.36|0.8059
72510458|NCT04346628|144551150|SUPERIORITY||Hazard Ratio (HR)|0.87||||0.59|TWO_SIDED|95.0|0.52|1.45||A p-value of 0.05 would have been considered statistically significant.|Cox proportional hazards model||Hazard ratio adjusted for age and sex|Difference in days until sustained resolution of symptoms||1.45|0.52|0.59
72566825|NCT02312713|144664441|SUPERIORITY||Mean Difference (Final Values)|-0.9||||0.05|TWO_SIDED|95.0|-1.82|0.02|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Wait List Control at 12 months.||0.02|-1.82|0.05
72401930|NCT02009046|144311199|SUPERIORITY||Odds Ratio (OR)|0.87||||0.6861|TWO_SIDED|95.0|0.44|1.71|||Regression, Logistic|Multilevel model to account for classroom/school clusters. Adjusted for student/classroom gender, student/classroom sexual experience, pretest score.||||1.71|0.44|0.6861
72401931|NCT02009046|144311199|SUPERIORITY||Odds Ratio (OR)|0.0||||0.9973|TWO_SIDED||||||Regression, Logistic|Multilevel model to account for classroom/school clusters. Adjusted for student/classroom gender, student/classroom sexual experience, pretest score.|No results provided, as model would not converge.|||||0.9973
72401932|NCT02009046|144311200|SUPERIORITY||Odds Ratio (OR)|1.97||||0.0002|TWO_SIDED|95.0|1.39|2.8|||Regression, Logistic|Multilevel model to account for classroom/school clusters. Adjusted for student/classroom gender, student/classroom sexual experience, pretest score.||||2.80|1.39|0.0002
72401933|NCT02009046|144311200|SUPERIORITY||Odds Ratio (OR)|2.71||||0.003|TWO_SIDED|95.0|1.44|5.09|||Regression, Logistic|Multilevel model to account for classroom/school clusters. Adjusted for student/classroom gender, student/classroom sexual experience, pretest score.||||5.09|1.44|0.0030
72510459|NCT03161938|144551154|SUPERIORITY||Odds Ratio (OR)|0.508||||0.248|TWO_SIDED|95.0|0.159|1.62|||Chi-squared, Corrected|||Null hypothesis: Patients receiving 48 mg of preoperative dexamethasone have less postoperative pain. Power calculation: Acute pain is reduced from 70% to 35% for patients receiving 48 mg of dexamathesone, 80% power, 0.05 statistical significance level.||1.620|0.159|0.248
72510460|NCT03161938|144551155|SUPERIORITY|||||||0.519|||||||Wilcoxon (Mann-Whitney)|||||||0.519
72510461|NCT03161938|144551156|SUPERIORITY|||||||0.468|||||||Wilcoxon (Mann-Whitney)|||||||0.468
72510462|NCT03161938|144551157|SUPERIORITY|||||||0.913|||||||Wilcoxon (Mann-Whitney)|||Maximal pain||||0.913
72510463|NCT03161938|144551157|SUPERIORITY|||||||0.722|||||||Wilcoxon (Mann-Whitney)|||Average pain||||0.722
72510464|NCT03161938|144551158|SUPERIORITY||Odds Ratio (OR)|1.19||||0.768|TWO_SIDED|95.0|0.374|3.793|||Chi-squared, Corrected|||||3.793|0.374|0.768
72510465|NCT03161938|144551159|SUPERIORITY|||||||0.133|||||||Regression, Linear|||||||0.133
72510466|NCT03161938|144551160|SUPERIORITY|||||||0.768||||||Not adjusted for multiple comparisons, statistical level of significance 0.01 (bonferroni correction)|Chi-squared, Corrected|||Day 0||||0.768
72510467|NCT03161938|144551160|SUPERIORITY|||||||0.376|||||||Chi-squared, Corrected|||Day 1||||0.376
72510468|NCT03161938|144551160|SUPERIORITY|||||||0.59|||||||Chi-squared, Corrected|||Day 2||||0.590
72510469|NCT03161938|144551160|SUPERIORITY|||||||0.32|||||||Chi-squared, Corrected|||Day 3||||0.320
72510470|NCT03161938|144551160|SUPERIORITY|||||||0.666|||||||Chi-squared, Corrected|||day 4||||0.666
72510471|NCT03161938|144551161|SUPERIORITY||||||>|0.999|||||||Chi-squared, Corrected|||day 0||||>0.999
72510472|NCT03161938|144551161|SUPERIORITY|||||||0.154|||||||Chi-squared, Corrected|||day 1||||0.154
72510473|NCT03161938|144551161|SUPERIORITY|||||||0.447|||||||Chi-squared, Corrected|||day 2||||0.447
72510474|NCT03161938|144551161|SUPERIORITY|||||||0.678|||||||Chi-squared, Corrected|||day 3||||0.678
72510475|NCT03161938|144551161|SUPERIORITY|||||||0.604|||||||Chi-squared, Corrected|||day 4||||0.604
72510476|NCT03161938|144551162|SUPERIORITY|||||||0.075|||||||Chi-squared, Corrected|||day 0, sadness||||0.075
72510477|NCT03161938|144551162|SUPERIORITY|||||||0.447|||||||Chi-squared, Corrected|||day 0, restlessness||||0.447
72510478|NCT03161938|144551162|SUPERIORITY|||||||0.703|||||||Chi-squared, Corrected|||Day 0, fatigue||||0.703
72510479|NCT03161938|144551162|SUPERIORITY|||||||0.731|||||||Chi-squared, Corrected|||Day 1, sadness||||0.731
72510480|NCT03161938|144551162|SUPERIORITY|||||||0.052|||||||Chi-squared, Corrected|||Day 1, restlessness||||0.052
72510481|NCT03161938|144551162|SUPERIORITY|||||||0.807|||||||Chi-squared, Corrected|||Day 1, fatigue||||0.807
72510482|NCT03161938|144551162|SUPERIORITY|||||||0.371|||||||Chi-squared, Corrected|||Day 2, sadness||||0.371
72510483|NCT03161938|144551162|SUPERIORITY|||||||0.064|||||||Chi-squared, Corrected|||Day 2, restlessness||||0.064
72401934|NCT00620828|144311206|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||t-test, 2 sided|||Patient cohort was inclusive of patient undergoing single TKA from June 2007 to July 2008. Effect size was calculated for the numeric pain rating scale at the immediate post-operative period, 4-hour, 8-hour , 12-hour, and 24-hour time periods as a means to assess post-operative pain control.||||<0.05
72401935|NCT00620828|144311207|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANOVA|||Significant differences in Fentanyl PCA pump usage across study arms were assessed for the 4-8h,8-12h,and 12h-24h time frames.||||.05
72510484|NCT03161938|144551162|SUPERIORITY|||||||0.11|||||||Chi-squared, Corrected|||day 2, fatigue||||0.110
72510485|NCT03161938|144551162|SUPERIORITY|||||||0.531|||||||Chi-squared, Corrected|||Day 3, sadness||||0.531
72510486|NCT03161938|144551162|SUPERIORITY|||||||0.954|||||||Chi-squared, Corrected|||Day 3, restlessness||||0.954
72510487|NCT03161938|144551162|SUPERIORITY|||||||0.526|||||||Chi-squared, Corrected|||Day 3, fatigue||||0.526
72510488|NCT03161938|144551162|SUPERIORITY|||||||0.491|||||||Chi-squared, Corrected|||Day 4, sadness||||0.491
72510489|NCT03161938|144551162|SUPERIORITY|||||||0.042|||||||Chi-squared, Corrected|||Day 4, restlessness||||0.042
72510490|NCT03161938|144551162|SUPERIORITY|||||||0.097|||||||Chi-squared, Corrected|||Day 4, fatigue||||0.097
72510491|NCT03161938|144551163|SUPERIORITY|||||||0.613|||||||Chi-squared, Corrected|||||||0.613
72510492|NCT04590937|144551210|OTHER|"ANOVA model including subject as random and treatment as fixed effect was used."|Geometric means ratio|98.22|STANDARD_ERROR_OF_MEAN|5.2|||TWO_SIDED|90.0|94.89|101.67|||||The geometric means ratio was calculated as Metformin + BI 730357 / Metformin. Standard error of the mean is actually the intra-individual geometric coefficient of variation (gCV).|||101.67|94.89|
72510493|NCT04590937|144551211|OTHER|"ANOVA model including subject as random and treatment as fixed effect was used."|Geometric means ratio|123.08|STANDARD_ERROR_OF_MEAN|12.7|||TWO_SIDED|90.0|112.22|134.98|||||The geometric means ratio was calculated as Rosuvastatin + BI 730357 / Rosuvastatin. Standard error of the mean is actually the intra-individual geometric coefficient of variation (gCV).|||134.98|112.22|
72510494|NCT04590937|144551212|OTHER|"ANOVA model including subject as random and treatment as fixed effect was used."|Geometric means ratio|117.72|STANDARD_ERROR_OF_MEAN|9.0|||TWO_SIDED|90.0|110.57|125.34|||||The geometric means ratio was calculated as Furosemide + BI 730357 / Furosemide. Standard error of the mean is actually the intra-individual geometric coefficient of variation (gCV).|||125.34|110.57|
72510495|NCT04590937|144551213|OTHER|"ANOVA model including subject as random and treatment as fixed effect was used."|Geometric means ratio|170.29|STANDARD_ERROR_OF_MEAN|25.6|||TWO_SIDED|90.0|143.73|201.76|||||The geometric means ratio was calculated as Digoxin + BI 730357 / Digoxin. Standard error of the mean is actually the intra-individual geometric coefficient of variation (gCV).|||201.76|143.73|
72566826|NCT02312713|144664441|SUPERIORITY||Mean Difference (Final Values)|-0.55||||0.19|TWO_SIDED|95.0|-1.37|0.27|||Mixed Models Analysis|||This is the comparison between Internet Based Exercise Training and Wait List Control at 4 months.||0.27|-1.37|0.19
72401936|NCT00620828|144311208|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||t-test, 1 sided|||This analysis was performed on data collected 24-hours post-operatively for patient cohort.||||.05
72401937|NCT00620828|144311209|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||t-test, 1 sided|||Knee extension and knee flexion measured at 24-hours post-operatively for patient cohort.||||.05
72401938|NCT00620828|144311210|SUPERIORITY_OR_OTHER|||||||0.05|||||||Chi-squared|||Straight leg raise data collected at 4-hours, 8-hours, 12-hours and 24-hours post-operatively for patient cohort.||||.05
72401939|NCT02073279|144311214|SUPERIORITY||Hazard Ratio (HR)|0.45||||0.0184|TWO_SIDED|95.0|0.23|0.89|||Log Rank|||Stratified by prior therapy (B-cell depleting therapy or immunosuppressants/others) and most recent attack (first attack or relapse).||0.89|0.23|0.0184
72401940|NCT02073279|144311215|SUPERIORITY||Mean Difference (Final Values)|3.215|STANDARD_ERROR_OF_MEAN|4.178||0.4436||95.0|-5.086|11.515|||ANCOVA|ANCOVA model: treatment group as fixed effect and baseline measurements, prior therapy, most recent attack (first attack/relapse) as covariates.||||11.515|-5.086|0.4436
72510496|NCT04590937|144551214|OTHER|"ANOVA model including subject as random and treatment as fixed effect was used."|Geometric means ratio|91.42|STANDARD_ERROR_OF_MEAN|5.6|||TWO_SIDED|90.0|88.04|94.93|||||The geometric means ratio was calculated as Metformin + BI 730357 / Metformin. Standard error of the mean is actually the intra-individual geometric coefficient of variation (gCV).|||94.93|88.04|
72510497|NCT04590937|144551215|OTHER|"ANOVA model including subject as random and treatment as fixed effect was used."|Geometric means ratio|139.03|STANDARD_ERROR_OF_MEAN|16.9|||TWO_SIDED|90.0|124.29|155.51|||||The geometric means ratio was calculated as Rosuvastatin + BI 730357 / Rosuvastatin. Standard error of the mean is actually the intra-individual geometric coefficient of variation (gCV).|||155.51|124.29|
72510498|NCT04590937|144551216|OTHER|"ANOVA model including subject as random and treatment as fixed effect was used."|Geometric means ratio|112.1|STANDARD_ERROR_OF_MEAN|15.4|||TWO_SIDED|90.0|101.26|124.11|||||The geometric means ratio was calculated as Furosemide + BI 730357 / Furosemide. Standard error of the mean is actually the intra-individual geometric coefficient of variation (gCV).|||124.11|101.26|
72510499|NCT04590937|144551217|OTHER|"ANOVA model including subject as random and treatment as fixed effect was used."|Geometric means ratio|161.29|STANDARD_ERROR_OF_MEAN|34.1|||TWO_SIDED|90.0|129.17|201.39|||||The geometric means ratio was calculated as Digoxin + BI 730357 / Digoxin. Standard error of the mean is actually the intra-individual geometric coefficient of variation (gCV).|||201.39|129.17|
72510500|NCT04590937|144551218|OTHER|"ANOVA model including subject as random and treatment as fixed effect was used."|Geometric means ratio|98.23|STANDARD_ERROR_OF_MEAN|5.2|||TWO_SIDED|90.0|94.86|101.73|||||The geometric means ratio was calculated as Metformin + BI 730357 / Metformin. Standard error of the mean is actually the intra-individual geometric coefficient of variation (gCV).|||101.73|94.86|
72401941|NCT02073279|144311216|SUPERIORITY||Mean Difference (Final Values)|2.107|STANDARD_ERROR_OF_MEAN|1.567||0.1824||95.0|-1.008|5.221|||ANCOVA|ANCOVA model included treatment group as fixed effect. Baseline measurements, prior therapy, most recent attack (first attack/relapse) as covariates.||||5.221|-1.008|0.1824
72401942|NCT00973479|144311246|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
72401943|NCT00973479|144311247|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
72401944|NCT00973479|144311248|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA of van der Waerden scores|||||||<0.001
72401945|NCT00973479|144311249|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
72401946|NCT00973479|144311250|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA of van der Waerden scores|||||||<0.001
72510501|NCT04590937|144551219|OTHER|"ANOVA model including subject as random and treatment as fixed effect was used."|Geometric means ratio|118.67|STANDARD_ERROR_OF_MEAN|13.0|||TWO_SIDED|90.0|108.83|129.4|||||The geometric means ratio was calculated as Rosuvastatin + BI 730357 / Rosuvastatin. Standard error of the mean is actually the intra-individual geometric coefficient of variation (gCV).|||129.40|108.83|
72510502|NCT04590937|144551220|OTHER|"ANOVA model including subject as random and treatment as fixed effect was used."|Geometric means ratio|114.07|STANDARD_ERROR_OF_MEAN|8.3|||TWO_SIDED|90.0|107.93|120.56|||||The geometric means ratio was calculated as Furosemide + BI 730357 / Furosemide. Standard error of the mean is actually the intra-individual geometric coefficient of variation (gCV).|||120.56|107.93|
72510503|NCT04590937|144551221|OTHER|"ANOVA model including subject as random and treatment as fixed effect was used."|Geometric means ratio|173.77|STANDARD_ERROR_OF_MEAN|30.8|||TWO_SIDED|90.0|141.9|212.8|||||The geometric means ratio was calculated as Digoxin + BI 730357 / Digoxin. Standard error of the mean is actually the intra-individual geometric coefficient of variation (gCV).|||212.80|141.90|
72566827|NCT02312713|144664441|SUPERIORITY||Mean Difference (Final Values)|-0.89||||0.06|TWO_SIDED|95.0|-1.83|0.05|||Mixed Models Analysis|||This is the comparison between Internet Based Exercise Training and Wait List Control at 12 months.||0.05|-1.83|0.06
72401947|NCT00335972|144311252|NON_INFERIORITY_OR_EQUIVALENCE|Sample size was based on being able to detect noninferiority on both analgesia (pain score and opioids) and hemodynamic responses, and superiority on at least one of them with 90% power and significance level of 0.025 for each of noninferiority and superiority. For MAP with a noninferiority delta of 7.5 mmHg and expected the SD of 12, we needed a maximum of N= 65 per group. Incorporating the two interim and one final analyses, we thus planned a maximum sample size of N=71/group (N=142 total).|Mean Difference (Net)|-9.0|||<|0.001|TWO_SIDED|95.0|-13.0|-5.0||Noninferiority confidence intervals are 95% (alpha of 0.05/2=0.025 in direction of interest). Bonferroni correction was used for superiority testing and 97.5% CI were reported.|repeated measures ANOVA||mean difference: Dexmedetomidine arm - Remifentanil arm|||-5|-13|<0.001
72401948|NCT00335972|144311252|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-9.0|||<|0.001|TWO_SIDED|97.5|-13.0|-4.0||Bonferroni correction was used for superiority testing since superiority on either hemodynamics or pain control would be interpreted as Dex better than Remi (alpha=0.0125 = 0.025/2, 97.5% CI).|repeated measures ANOVA model||mean difference: dexmedetomidine arm - remifentanil arm|superiority test||-4|-13|<0.001
72481652|NCT04079803|144490297|SUPERIORITY|||||||0.005||||||P value adjusted for multiplicity of 6 co-primary endpoints (p\<0.008 required for significance).|ANCOVA|General Linear Model for the analysis of covariance (ANCOVA) with a two-sided 95% confidence interval and baseline measurement as the covariate.||This primary analysis includes two 100 mg subjects who showed no detectable simufilam in plasma at return visits (their exclusion was not prespecified in the Statistical Analysis Plan).|In a secondary analysis removing two subjects with no detectable simufilam in plasma, P=0.003 and CFB was -3.2.|||0.005
72481653|NCT04079803|144490297|SUPERIORITY|||||||0.002||||||P value adjusted for multiplicity of 6 co-primary endpoints (p\<0.008 required for significance).|ANCOVA|General Linear Model for the analysis of covariance (ANCOVA) with a two-sided 95% confidence interval and baseline measurement as the covariate.||This primary analysis includes one 50 mg subject who showed no detectable simufilam in plasma at return visits (their exclusion was not prespecified in the Statistical Analysis Plan).|In a secondary analysis removing one subject with no detectable simufilam in plasma, P=0.003 and CFB was -2.5.|||0.002
72481654|NCT04079803|144490298|SUPERIORITY|||||||0.0002||||||P value adjusted for multiplicity of 6 co-primary endpoints (p\<0.008 required for significance).|ANCOVA|General Linear Model for the analysis of covariance (ANCOVA) with a two-sided 95% confidence interval and baseline measurement as the covariate.||This primary analysis includes two 100 mg subjects who showed no detectable simufilam in plasma at return visits (their exclusion was not prespecified in the Statistical Analysis Plan).|In a secondary analysis removing two subjects with no detectable simufilam in plasma, P=0.0002 and CFB was -681.|||0.0002
72481655|NCT04079803|144490298|SUPERIORITY|||||||0.0005||||||P value adjusted for multiplicity of 6 co-primary endpoints (p\<0.008 required for significance).|ANCOVA|General Linear Model for the analysis of covariance (ANCOVA) with a two-sided 95% confidence interval and baseline measurement as the covariate.||This primary analysis includes one 50 mg subject who showed no detectable simufilam in plasma at return visits (their exclusion was not prespecified in the Statistical Analysis Plan).|In a secondary analysis removing one subject with no detectable simufilam in plasma, P=0.0005 and CFB was -527.|||0.0005
72481656|NCT04079803|144490299|SUPERIORITY|||||||0.0003||||||P value adjusted for multiplicity of 6 co-primary endpoints (p\<0.008 required for significance).|ANCOVA|General Linear Model for the analysis of covariance (ANCOVA) with a two-sided 95% confidence interval and baseline measurement as the covariate.||This primary analysis includes two 100 mg subjects who showed no detectable simufilam in plasma at return visits (their exclusion was not prespecified in the Statistical Analysis Plan).|In a secondary analysis removing two subjects with no detectable simufilam in plasma, P=0.0002 and CFB was -78.5.|||0.0003
72481657|NCT04079803|144490299|SUPERIORITY|||||||0.0058||||||P value adjusted for multiplicity of 6 co-primary endpoints (p\<0.008 required for significance).|ANCOVA|General Linear Model for the analysis of covariance (ANCOVA) with a two-sided 95% confidence interval and baseline measurement as the covariate.||This primary analysis includes one 50 mg subject who showed no detectable simufilam in plasma at return visits (their exclusion was not prespecified in the Statistical Analysis Plan).|In a secondary analysis removing one subject with no detectable simufilam in plasma, P=0.0008 and CFB was -51.0.|||0.0058
72481658|NCT04079803|144490300|SUPERIORITY|||||||0.0001||||||P value adjusted for multiplicity of 6 co-primary endpoints (p\<0.008 required for significance).|ANCOVA|General Linear Model for the analysis of covariance (ANCOVA) with a two-sided 95% confidence interval and baseline measurement as the covariate.||This primary analysis includes two 100 mg subjects who showed no detectable simufilam in plasma at return visits (their exclusion was not prespecified in the Statistical Analysis Plan).|In a secondary analysis removing two subjects with no detectable simufilam in plasma, P=0.0001 and CFB was -23.7.|||0.0001
72481659|NCT04079803|144490300|SUPERIORITY|||||||0.0001||||||P value adjusted for multiplicity of 6 co-primary endpoints (p\<0.008 required for significance).|ANCOVA|General Linear Model for the analysis of covariance (ANCOVA) with a two-sided 95% confidence interval and baseline measurement as the covariate.||This primary analysis includes one 50 mg subject who showed no detectable simufilam in plasma at return visits (their exclusion was not prespecified in the Statistical Analysis Plan).|In a secondary analysis removing one subject with no detectable simufilam in plasma, P=0.0002 and CFB was -20.9.|||0.0001
72481660|NCT04079803|144490301|OTHER||Effect size|0.23|||||TWO_SIDED||||||||Reported effect size vs. placebo was calculated with Hedge's g (for groups of 20 or fewer) but was identical when calculated by Cohen's d.|This study was not powered for statistical significance on cognitive measures.||||
72481661|NCT04079803|144490301|OTHER||Effect size|0.37|||||TWO_SIDED||||||||Reported effect size vs. placebo was calculated with Hedge's g (for groups of 20 or fewer) but was identical when calculated by Cohen's d.|This study was not powered for statistical significance on cognitive measures.||||
72510504|NCT04743635|144551232|OTHER|"Performance goal.~Hypothesis:~Ho: D \< 1 Ha: D ≥ 1, where D = reduction in the CSS score from baseline to 3 months, and 1 is the performance goal. If the lower bound of the two-sided 95% confidence interval is greater than or equal to 1 then we will reject the null hypothesis and conclude the device performs effectively."|Mean Difference (Final Values)|1.5|STANDARD_DEVIATION|0.9||0.0001|TWO_SIDED|95.0|1.28|1.71|||t-test, 2 sided|The 2-sided 95% confidence interval for the mean reduction in CSS was calculated along with the corresponding p-value (Student's t-test).||The endpoint tested the mean of the changes for each treated participant, not a 1-point change between mean score of the group at baseline versus 3 months. Success is achieved when the mean change across all treated participants is at least one point.||1.71|1.28|.0001
72481662|NCT04079803|144490302|OTHER||Effect size|0.46|||||TWO_SIDED||||||||Reported effect size vs. placebo was calculated with Hedge's g (for groups of 20 or fewer) but was almost identical (0.45) when calculated by Cohen's d.|This study was not powered for statistical significance on cognitive measures.||||
72623986|NCT02231580|144778418|SUPERIORITY_OR_OTHER||GLS mean ratio|0.953|||=|0.8277|TWO_SIDED|90.0|0.662|1.372|||MMRM|||Right finger IOI variability statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||1.372|0.662|=0.8277
72481663|NCT04079803|144490302|OTHER||Effect size|0.25|||||TWO_SIDED||||||||Reported effect size vs. placebo was calculated with Hedge's g (for groups of 20 or fewer) but was identical when calculated by Cohen's d.|This study was not powered for statistical significance on cognitive measures.||||
72481664|NCT04079803|144490303|SUPERIORITY|||||||0.0078||||||Secondary CSF biomarkers were not adjusted for multiplicity.|ANCOVA|General Linear Model for the analysis of covariance (ANCOVA) with a two-sided 95% confidence interval and baseline measurement as the covariate.||This analysis is for IL-6.||||0.0078
72481665|NCT04079803|144490303|SUPERIORITY|||||||0.019||||||Secondary CSF biomarkers were not adjusted for multiplicity.|ANCOVA|General Linear Model for the analysis of covariance (ANCOVA) with a two-sided 95% confidence interval and baseline measurement as the covariate.||This analysis is for IL-6.||||0.019
72481666|NCT04079803|144490303|SUPERIORITY|||||||0.0002||||||Secondary CSF biomarkers were not adjusted for multiplicity.|ANCOVA|General Linear Model for the analysis of covariance (ANCOVA) with a two-sided 95% confidence interval and baseline measurement as the covariate.||This analysis is for sTREM2.||||0.0002
72481667|NCT04079803|144490303|SUPERIORITY|||||||0.0007||||||Secondary CSF biomarkers were not adjusted for multiplicity.|ANCOVA|General Linear Model for the analysis of covariance (ANCOVA) with a two-sided 95% confidence interval and baseline measurement as the covariate.||This analysis is for sTREM2.||||0.0007
72481668|NCT04079803|144490303|SUPERIORITY|||||||0.0001||||||Secondary CSF biomarkers were not adjusted for multiplicity.|ANCOVA|General Linear Model for the analysis of covariance (ANCOVA) with a two-sided 95% confidence interval and baseline measurement as the covariate.||This analysis is for HMGB1.||||0.0001
72481669|NCT04079803|144490303|SUPERIORITY|||||||0.0001||||||Secondary CSF biomarkers were not adjusted for multiplicity.|ANCOVA|General Linear Model for the analysis of covariance (ANCOVA) with a two-sided 95% confidence interval and baseline measurement as the covariate.||This analysis is for HMGB1.||||0.0001
72481670|NCT04079803|144490303|SUPERIORITY|||||||0.0001||||||Secondary CSF biomarkers were not adjusted for multiplicity.|ANCOVA|General Linear Model for the analysis of covariance (ANCOVA) with a two-sided 95% confidence interval and baseline measurement as the covariate.||This analysis is for albumin.||||0.0001
72481671|NCT04079803|144490303|SUPERIORITY|||||||0.046||||||Secondary CSF biomarkers were not adjusted for multiplicity.|ANCOVA|General Linear Model for the analysis of covariance (ANCOVA) with a two-sided 95% confidence interval and baseline measurement as the covariate.||This analysis is for albumin.||||0.046
72481672|NCT04079803|144490303|SUPERIORITY|||||||0.012||||||Secondary CSF biomarkers were not adjusted for multiplicity.|ANCOVA|General Linear Model for the analysis of covariance (ANCOVA) with a two-sided 95% confidence interval and baseline measurement as the covariate.||This analysis is for Immunoglobulin G.||||0.012
72481673|NCT04079803|144490303|SUPERIORITY|||||||0.014||||||Secondary CSF biomarkers were not adjusted for multiplicity.|ANCOVA|General Linear Model for the analysis of covariance (ANCOVA) with a two-sided 95% confidence interval and baseline measurement as the covariate.||This analysis is for Immunoglobulin G.||||0.014
72481674|NCT04079803|144490304|SUPERIORITY|||||||0.005||||||As secondary endpoints, lymphocyte biomarkers were not adjusted for multiplicity.|ANOVA|ANOVA was used instead of ANCOVA due to the range in baseline values; it was deemed more appropriate to compare to each subject's own baseline value.||Change from baseline in FLNA linkage to alpha7nAChR in subject lymphocytes. FLNA linkage to alpha7nAChR was expressed as the ratio of densitometric units of immunoblot bands of alpha7nAChR (probed with a specific antibody) to densitometric units of total FLNA.||||0.005
72481675|NCT04079803|144490304|SUPERIORITY|||||||0.009||||||As secondary endpoints, lymphocyte biomarkers were not adjusted for multiplicity.|ANOVA|ANOVA was used instead of ANCOVA due to the range in baseline values; it was deemed more appropriate to compare to each subject's own baseline value.||Change from baseline in FLNA linkage to alpha7nAChR in subject lymphocytes. FLNA linkage to alpha7nAChR was expressed as ratios of densitometric units of immunoblot bands of alpha7nAChR (probed with a specific antibody) to densitometric units of total FLNA.||||0.009
72481676|NCT04079803|144490304|SUPERIORITY|||||||0.01||||||As secondary endpoints, lymphocyte biomarkers were not adjusted for multiplicity.|ANOVA|ANOVA was used instead of ANCOVA due to the range in baseline values; it was deemed more appropriate to compare to each subject's own baseline value.||Change from baseline in FLNA linkage to TLR4 in subject lymphocytes. FLNA linkage to TLR4 was expressed as the ratio of densitometric units of immunoblot bands of TLR4 (probed with a specific antibody) to densitometric units of total FLNA.||||0.01
72481677|NCT04079803|144490304|SUPERIORITY|||||||0.01||||||As secondary endpoints, lymphocyte biomarkers were not adjusted for multiplicity.|ANOVA|ANOVA was used instead of ANCOVA due to the range in baseline values; it was deemed more appropriate to compare to each subject's own baseline value.||Change from baseline in FLNA linkage to TLR4 in subject lymphocytes. FLNA linkage to TLR4 was expressed as the ratio of densitometric units of immunoblot bands of TLR4 (probed with a specific antibody) to densitometric units of total FLNA.||||0.01
72481678|NCT04079803|144490305|SUPERIORITY|||||||0.01|||||||ANOVA|ANOVA followed by Dunnett's multiple comparisons test.||||||0.01
72481679|NCT04079803|144490305|SUPERIORITY|||||||0.02|||||||ANOVA|ANOVA followed by Dunnett's multiple comparisons test.||||||0.02
72481680|NCT04079803|144490305|SUPERIORITY|||||||0.009|||||||ANOVA|This p value is for the main effect of treatment of the ANOVA.||||||0.009
72481681|NCT04079803|144490306|SUPERIORITY|||||||0.003|||||||ANOVA|||||||0.003
72481682|NCT04079803|144490306|SUPERIORITY|||||||0.016|||||||ANOVA|||||||0.016
72481683|NCT01881750|144490307|SUPERIORITY_OR_OTHER|||||||0.42|||||||Mixed Effects Regression Model|||Group X Time Interaction Cohen's d||||0.42
72481684|NCT01106404|144490324|SUPERIORITY_OR_OTHER||binomial proportion|0.865|||<|0.001|ONE_SIDED|97.5|0.765||||Fisher Exact||In this ITT analysis, the combined percentage of subjects with improved pain relief and/or convenience during the AdaptiveStim programming relative to the manual programming in both groups was reported.|"ITT analysis:~Hypothesis: The percentage of subjects who succeed must be greater than 25%. H0: p ≤ 0.25 HA: p \> 0.25"|||0.765|< 0.001
72481685|NCT01106404|144490324|SUPERIORITY_OR_OTHER||binomial proportion|0.901|||<|0.001|ONE_SIDED|97.5|0.807||||Fisher Exact||In this completed case analysis, the combined percentage of subjects with improved pain relief and/or convenience during the AdaptiveStim programming relative to the manual programming in both groups was reported.|Completed case analysis|||0.807|< 0.001
72481686|NCT01106404|144490325|SUPERIORITY_OR_OTHER||binomial proportion|0.028|||||TWO_SIDED|95.0|0.003|0.098|||||The combined percentage of subjects with worsened pain relief was reported.|||0.098|0.003|
72481687|NCT01106404|144490326|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.8|STANDARD_DEVIATION|51.9|<|0.001||95.0|||||Wilcoxon signed rank test|||||||< 0.001
72481688|NCT01106404|144490327|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.77|STANDARD_DEVIATION|1.93|<|0.001||95.0|||||Wilcoxon signed rank test|||||||< 0.001
72481689|NCT01106404|144490327|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.5|STANDARD_DEVIATION|2.04|<|0.001|TWO_SIDED|95.0|||||Wilcoxon signed rank test|||||||< 0.001
72481690|NCT01296347|144490391|SUPERIORITY|||||||0.33|||||||Wilcoxon (Mann-Whitney)|||||||0.33
72481691|NCT01296347|144490392|SUPERIORITY|||||||0.71|||||||Wilcoxon (Mann-Whitney)|||6 weeks||||0.71
72481692|NCT01296347|144490392|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||3 month||||1.0
72481693|NCT01296347|144490392|SUPERIORITY|||||||0.32|||||||Wilcoxon (Mann-Whitney)|||6 months||||0.32
72481694|NCT01296347|144490394|SUPERIORITY|||||||0.47|||||||Wilcoxon (Mann-Whitney)|||||||0.47
72481695|NCT01296347|144490395|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||||||1.00
72623987|NCT02231580|144778418|SUPERIORITY_OR_OTHER||GLS mean ratio|1.238|||=|0.0162|TWO_SIDED|90.0|1.074|1.426|||MMRM|||Left finger IOI duration statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||1.426|1.074|=0.0162
72481696|NCT01296347|144490396|SUPERIORITY|||||||0.02|||||||Wilcoxon (Mann-Whitney)|||||||0.02
72510505|NCT04743635|144551233|OTHER|Performance goal. The hierarchal endpoint is met if the lower bound of the 2-sided 95% confidence interval is greater than or equal to 0.6.|Percentage improved|95.6||||0.0001|TWO_SIDED|95.0|87.6|99.1|||t-test, 2 sided|||"The GAIS scale counted if at least two of the three evaluators selected it, otherwise the median between the three was counted (e.g., if improved, worse and much worse, worse was counted). A participant is considered improved if the GAIS assessment is improved (1), much improved (2) or very much improved (3)."||99.1|87.6|.0001
72510506|NCT04743635|144551236|OTHER|Performance goal. In order to meet the endpoint, the lower bound of the 2-sided 95% confidence interval had to be greater than or equal to 0.6.|Percentage improved|72.1||||0.0264|TWO_SIDED|95.0|59.9|82.3|||t-test, 2 sided|||||82.3|59.9|.0264
72481697|NCT01296347|144490397|SUPERIORITY|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||||||0.001
72481698|NCT02240693|144490398|SUPERIORITY|H0: The dose group with the peak response in the respective model Mean NTB response = Mean NTB response of placebo.|Mean Difference (Final Values)|0.07|STANDARD_ERROR_OF_MEAN|0.075||0.3236|TWO_SIDED|95.0|-0.074|0.223||p-value was nominal and not adjusted.|Mixed Model Repeated Measurement (MMRM)|Kenward-Roger was used to model degrees of freedom.|Mean difference (BI 409306 10 milligram (mg) once daily (QD) minus Placebo matching BI 409306)|Mixed Model Repeated Measurement (MMRM) includes fixed, categorical effects of treatment, visit, and treatment-by-visit interaction, as well as the continuous fixed covariates of baseline, and baseline-by-visit interaction.|The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|0.223|-0.074|0.3236
72481699|NCT02240693|144490398|SUPERIORITY|H0: The dose group with the peak response in the respective model Mean NTB response = Mean NTB response of placebo.|Mean Difference (Final Values)|-0.07|STANDARD_ERROR_OF_MEAN|0.076||0.3694|TWO_SIDED|95.0|-0.22|0.082||p-value was nominal and not adjusted.|Mixed Model Repeated Measurement (MMRM)|Kenward-Roger was used to model degrees of freedom.|Mean difference (BI 409306 25 mg QD minus Placebo matching BI 409306)|Mixed Model Repeated Measurement (MMRM) includes fixed, categorical effects of treatment, visit, and treatment-by-visit interaction, as well as the continuous fixed covariates of baseline, and baseline-by-visit interaction.|The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|0.082|-0.220|0.3694
72481700|NCT02240693|144490398|SUPERIORITY|H0: The dose group with the peak response in the respective model Mean NTB response = Mean NTB response of placebo.|Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.078||0.8374|TWO_SIDED|95.0|-0.171|0.139||p-value was nominal and not adjusted.|Mixed Model Repeated Measurement (MMRM)|Kenward-Roger was used to model degrees of freedom.|Mean difference (BI 409306 50 mg QD minus Placebo matching BI 409306)|Mixed Model Repeated Measurement (MMRM) includes fixed, categorical effects of treatment, visit, and treatment-by-visit interaction, as well as the continuous fixed covariates of baseline, and baseline-by-visit interaction.|The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences|0.139|-0.171|0.8374
72510507|NCT03382899|144551238|SUPERIORITY||Odds Ratio (OR)|1.1||||0.7626|TWO_SIDED|95.0|0.5|2.5|||Cochran-Mantel-Haenszel||Odds Ratio stratified by histology type, squamous versus non-squamous based on interactive web response system (IWRS). 95% Confidence intervals (CIs) were estimated using the Clopper-Pearson method.|||2.5|0.5|0.7626
72510508|NCT03382899|144551239|SUPERIORITY||Hazard Ratio (HR)|1.53||||0.263|TWO_SIDED|95.0|0.722|3.243|||Log Rank||Hazard Ratio stratified by histology type, squamous versus non-squamous based on IWRS. 95% CIs were estimated using the methods of Brookmeyer and Crowley, and Greenwood, respectively.|||3.243|0.722|0.263
72481701|NCT02240693|144490398|SUPERIORITY|H0: The dose group with the peak response in the respective model Mean NTB response = Mean NTB response of placebo.|Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.077||0.5484|TWO_SIDED|95.0|-0.106|0.199||p-value was nominal and not adjusted.|Mixed Model Repeated Measurement (MMRM)|Kenward-Roger was used to model degrees of freedom.|Mean difference (BI 409306 25 mg twice daily (BID) minus Placebo matching BI 409306)|Mixed Model Repeated Measurement (MMRM) includes fixed, categorical effects of treatment, visit, and treatment-by-visit interaction, as well as the continuous fixed covariates of baseline, and baseline-by-visit interaction.|The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences|0.199|-0.106|0.5484
72481702|NCT02240693|144490398|SUPERIORITY|H0: The dose group with the peak response in the respective model Mean NTB response = Mean NTB response of placebo.|Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.054||0.7905|TWO_SIDED|95.0|-0.092|0.121||p-value was nominal and not adjusted.|Mixed Model Repeated Measurement (MMRM)|Kenward-Roger was used to model degrees of freedom.|Mean difference (Pooled BI 409306 minus Placebo matching BI 409306)|Mixed Model Repeated Measurement (MMRM) includes fixed, categorical effects of treatment, visit, and treatment-by-visit interaction, as well as the continuous fixed covariates of baseline, and baseline-by-visit interaction.|The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences|0.121|-0.092|0.7905
72481703|NCT02240693|144490399|SUPERIORITY|Analyses of covariance (ANCOVA) were used to assess between-group differences in the modelled changes from baseline to Week 12.|Mean Difference (Final Values)|-0.14|STANDARD_ERROR_OF_MEAN|1.102||0.8973|TWO_SIDED|95.0|-2.33|2.04||p-value was nominal and not adjusted.|ANCOVA||Mean difference (BI 409306 10 milligram (mg) once daily (QD) minus Placebo matching BI 409306)|The dependent variable was the change from the baseline score at Week 12. The model included fixed, categorical covariates of treatment as well as fixed continuous covariates of baseline score.|The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|2.04|-2.33|0.8973
72481704|NCT02240693|144490399|SUPERIORITY|Analyses of covariance (ANCOVA) were used to assess between-group differences in the modelled changes from baseline to Week 12.|Mean Difference (Final Values)|1.4|STANDARD_ERROR_OF_MEAN|1.122||0.2141|TWO_SIDED|95.0|-0.82|3.63||p-value was nominal and not adjusted.|ANCOVA||Mean difference (BI 409306 25 mg QD minus Placebo matching BI 409306)|The dependent variable was the change from the baseline score at Week 12. The model included fixed, categorical covariates of treatment as well as fixed continuous covariates of baseline score.|The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|3.63|-0.82|0.2141
72481705|NCT02240693|144490399|SUPERIORITY|Analyses of covariance (ANCOVA) were used to assess between-group differences in the modelled changes from baseline to Week 12.|Mean Difference (Final Values)|-0.49|STANDARD_ERROR_OF_MEAN|1.085||0.6553|TWO_SIDED|95.0|-2.64|1.67||p-value was nominal and not adjusted.|ANCOVA||Mean difference (BI 409306 50 mg QD minus Placebo matching BI 409306)|The dependent variable was the change from the baseline score at Week 12. The model included fixed, categorical covariates of treatment as well as fixed continuous covariates of baseline score.|The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences|1.67|-2.64|0.6553
72481706|NCT02240693|144490399|SUPERIORITY|Analyses of covariance (ANCOVA) were used to assess between-group differences in the modelled changes from baseline to Week 12.|Mean Difference (Final Values)|0.42|STANDARD_ERROR_OF_MEAN|1.144||0.7166|TWO_SIDED|95.0|-1.85|2.69||p-value was nominal and not adjusted.|ANCOVA||Mean difference (BI 409306 25 mg twice daily (BID) minus Placebo matching BI 409306)|The dependent variable was the change from the baseline score at Week 12. The model included fixed, categorical covariates of treatment as well as fixed continuous covariates of baseline score.|The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences|2.69|-1.85|0.7166
72481707|NCT02240693|144490400|SUPERIORITY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.24||0.9491|TWO_SIDED|95.0|-0.49|0.46||p-value was nominal and not adjusted.|Mixed Model Repeated Measurement (MMRM)|Kenward-Roger was used to model degrees of freedom.|Mean difference (BI 409306 10 milligram (mg) once daily (QD) minus Placebo matching BI 409306)|Mixed Model Repeated Measurement (MMRM) includes fixed, categorical effects of treatment, visit, and treatment-by-visit interaction, as well as the continuous fixed covariates of baseline, and baseline-by-visit interaction.|The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|0.46|-0.49|0.9491
72481708|NCT02240693|144490400|SUPERIORITY||Mean Difference (Final Values)|0.3|STANDARD_ERROR_OF_MEAN|0.25||0.1699|TWO_SIDED|95.0|-0.15|0.84||p-value was nominal and not adjusted.|Mixed Model Repeated Measurement (MMRM)|Kenward-Roger was used to model degrees of freedom.|Mean difference (BI 409306 25 mg QD minus Placebo matching BI 409306)|Mixed Model Repeated Measurement (MMRM) includes fixed, categorical effects of treatment, visit, and treatment-by-visit interaction, as well as the continuous fixed covariates of baseline, and baseline-by-visit interaction.|The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|0.84|-0.15|0.1699
72510509|NCT03382899|144551240|SUPERIORITY||Hazard Ratio (HR)|0.975||||0.2|TWO_SIDED|95.0|0.571|1.663|||Log Rank||Hazard Ratio stratified by histology type, squamous versus non-squamous based on IWRS. 95% CIs were estimated using the Kaplan-Meier method.|||1.663|0.571|0.20
72510510|NCT03382899|144551241|SUPERIORITY||Odds Ratio (OR)|1.0||||0.9418|TWO_SIDED|95.0|0.5|2.3|||Cochran-Mantel-Haenszel||Odds Ratio stratified by histology type, squamous versus non-squamous based on IWRS. 95% CIs were estimated using the Clopper-Pearson method.|||2.3|0.5|0.9418
72510511|NCT03382899|144551242|SUPERIORITY||Hazard Ratio (HR)|1.124||||0.8312|TWO_SIDED|95.0|0.384|3.289|||Log Rank||Hazard Ratio stratified by histology type, squamous versus non-squamous based on IWRS. 95% CIs were estimated using the methods of Brookmeyer and Crowley, and Greenwood, respectively.|||3.289|0.384|0.8312
72510512|NCT00540449|144551243|NON_INFERIORITY_OR_EQUIVALENCE|If the lower limit of the 95% 2-sided confidence interval of the difference in proportions (TMC278 - EFV) exceeds -12%, non-inferiority of TMC278 versus EFV can be concluded.|Difference in proportion of response|-0.4|||<|0.0001||95.0|-5.9|5.2||Significance level was set at 2.5% (one-sided). No adjustment of p-value for multiple comparisons, since there was only single comparison for the primary endpoint.|Regression, Logistic|Logistic regression model included treatment arm as factor and baseline (log10) viral load as covariate.|Difference in proportion responders was estimated through the logistic regression model.|Assuming a response rate of 75% at 48 weeks for both treatment groups, 340 subjects were needed per treatment (TMC278 or EFV) to establish non-inferiority of TMC278 versus EFV with a maximum allowable difference of 12% and a 1-sided significance level of 2.5%, to yield 95% power.||5.2|-5.9|<0.0001
72510513|NCT00540449|144551244|NON_INFERIORITY_OR_EQUIVALENCE|If the lower limit of the 95% 2-sided confidence interval of the difference in proportions (TMC278 - EFV) exceeds -12%, non-inferiority of TMC278 versus EFV can be concluded.|Difference in proportion of response|0.3|||<|0.0001||95.0|-5.4|5.9|||Regression, Logistic|Logistic regression model included treatment arm as factor and baseline (log10) viral load as covariate.|Difference in proportion responders was estimated through the logistic regression model.|||5.9|-5.4|<0.0001
72510514|NCT00540449|144551245|NON_INFERIORITY_OR_EQUIVALENCE|If the lower limit of the 95% 2-sided confidence interval of the difference in proportions (TMC278 - EFV) exceeds -12%, non-inferiority of TMC278 versus EFV can be concluded.|Difference in proportion of response|-3.2||||0.0055||95.0|-9.4|3.1|||Regression, Logistic|Logistic regression model included treatment arm as factor and baseline (log10) viral load as covariate.|Difference in proportion responders was estimated through the logistic regression model.|||3.1|-9.4|0.0055
72623988|NCT02231580|144778418|SUPERIORITY_OR_OTHER||GLS mean ratio|1.038|||=|0.632|TWO_SIDED|90.0|0.912|1.182|||MMRM|||Right finger IOI duration statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||1.182|0.912|=0.6320
72623989|NCT02231580|144778419|SUPERIORITY_OR_OTHER||GLS mean ratio|1.308|||=|0.3005|TWO_SIDED|90.0|0.85|2.014|||MMRM|||Left finger variability of TD statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||2.014|0.85|=0.3005
72623990|NCT02231580|144778419|SUPERIORITY_OR_OTHER||GLS mean ratio|1.177|||=|0.4793|TWO_SIDED|90.0|0.804|1.722|||MMRM|||Right finger variability of TD statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||1.722|0.804|=0.4793
72401949|NCT00335972|144311253|NON_INFERIORITY_OR_EQUIVALENCE|Sample size was based on being able to detect noninferiority on both analgesia (pain score and opioids) and hemodynamic responses, and superiority on at least one of them with 90% power and significance level of 0.025 for each of noninferiority and superiority. For VRS pain, the standard deviation (SD) was expected to be about 1.75, such that with a noninferiority delta of 1, we needed a maximum of N= 66 per group|Mean Difference (Net)|-1.9|||<|0.001|TWO_SIDED|95.0|-2.7|-1.1||noninferiority confidence intervals are 95% (alpha of 0.05/2=0.025 in direction of interest).|repeated measures ANOVA model||mean difference: Dexmedetomidine arm - Remifentanil arm|||-1.1|-2.7|<0.001
72510515|NCT00540449|144551246|NON_INFERIORITY_OR_EQUIVALENCE|If the lower limit of the 95% 2-sided confidence interval of the difference in proportions (TMC278 - EFV) exceeds -12%, non-inferiority of TMC278 versus EFV can be concluded.|Difference in proportion of response|-1.7||||0.0013||95.0|-8.0|4.5|||Regression, Logistic|Logistic regression model included treatment arm as factor and baseline (log10) viral load as covariate.||||4.5|-8.0|0.0013
72510516|NCT02426658|144551272|SUPERIORITY|||||||0.7044|||||||Mixed Models Analysis|||||||0.7044
72510517|NCT02592629|144551315|EQUIVALENCE|ANOVA|||||<|0.05|||||||ANOVA|||||||<0.05
72510518|NCT01204658|144551317|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was supported if one could rule out an increase in terms of percentage of subjects (10PP-LD Group minus Synflorix Group) above 5% + half the incidence in the Synflorix Group (= null hypothesis) as shown by a 1-sided P-value \< 5%.|Difference in percentage|0.0||||0.003|TWO_SIDED|95.0|-2.61|2.57||1-sided P-value computed using Kem Philips' approach for ruling out an increase in % subjects with fever \> 40.0°C and causal relationship to vaccination \> the boundary expressed as 5% + 0.5\*rate in the Synflorix group.|Kem Phillip's statistical test|||Non-inferiority of 10PP-LD vaccine vs Synflorix™ vaccine post dose 1 was assessed by computing the difference in percentages of subjects reporting Grade 3 fever causally related to dose 1 vaccination in the 10PP-LD Group minus Synflorix Group.||2.57|-2.61|0.003
72623991|NCT02231580|144778419|SUPERIORITY_OR_OTHER||GLS mean ratio|1.15|||=|0.2653|TWO_SIDED|90.0|0.934|1.416|||MMRM|||Left finger duration of TD statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||1.416|0.934|=0.2653
72481709|NCT02240693|144490400|SUPERIORITY||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.26||0.4948|TWO_SIDED|95.0|-0.69|0.33||p-value was nominal and not adjusted.|Mixed Model Repeated Measurement (MMRM)|Kenward-Roger was used to model degrees of freedom.|Mean difference (BI 409306 50 mg QD minus Placebo matching BI 409306)|Mixed Model Repeated Measurement (MMRM) includes fixed, categorical effects of treatment, visit, and treatment-by-visit interaction, as well as the continuous fixed covariates of baseline, and baseline-by-visit interaction.|The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences|0.33|-0.69|0.4948
72481710|NCT02240693|144490400|SUPERIORITY||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.25||0.7548|TWO_SIDED|95.0|-0.42|0.58||p-value was nominal and not adjusted.|Mixed Model Repeated Measurement (MMRM)|Kenward-Roger was used to model degrees of freedom.|Mean difference (BI 409306 25 mg twice daily (BID) minus Placebo matching BI 409306)|Mixed Model Repeated Measurement (MMRM) includes fixed, categorical effects of treatment, visit, and treatment-by-visit interaction, as well as the continuous fixed covariates of baseline, and baseline-by-visit interaction.|The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences|0.58|-0.42|0.7548
72481711|NCT02240693|144490401|SUPERIORITY|Analyses of covariance (ANCOVA) were used to assess between-group differences in the modelled changes from baseline to Week 12.|Mean Difference (Final Values)|-0.26|STANDARD_ERROR_OF_MEAN|1.081||0.8137|TWO_SIDED|95.0|-2.4|1.89||p-value was nominal and not adjusted.|ANCOVA||Mean difference (BI 409306 10 milligram (mg) once daily (QD) minus Placebo matching BI 409306)|The dependent variable was the change from the baseline score at Week 12. The model included fixed, categorical covariates of treatment as well as fixed continuous covariates of baseline score.|The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|1.89|-2.40|0.8137
72481712|NCT02240693|144490401|SUPERIORITY|Analyses of covariance (ANCOVA) were used to assess between-group differences in the modelled changes from baseline to Week 12.|Mean Difference (Final Values)|-0.62|STANDARD_ERROR_OF_MEAN|1.12||0.5801|TWO_SIDED|95.0|-2.84|1.6||p-value was nominal and not adjusted.|ANCOVA||Mean difference (BI 409306 25 mg QD minus Placebo matching BI 409306)|The dependent variable was the change from the baseline score at Week 12. The model included fixed, categorical covariates of treatment as well as fixed continuous covariates of baseline score.|The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|1.60|-2.84|0.5801
72481713|NCT02240693|144490401|SUPERIORITY|Analyses of covariance (ANCOVA) were used to assess between-group differences in the modelled changes from baseline to Week 12.|Mean Difference (Final Values)|-1.12|STANDARD_ERROR_OF_MEAN|1.072||0.2978|TWO_SIDED|95.0|-3.25|1.0||p-value was nominal and not adjusted.|ANCOVA||Mean difference (BI 409306 50 mg QD minus Placebo matching BI 409306)|The dependent variable was the change from the baseline score at Week 12. The model included fixed, categorical covariates of treatment as well as fixed continuous covariates of baseline score.|The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences|1.00|-3.25|0.2978
72481714|NCT02240693|144490401|SUPERIORITY|Analyses of covariance (ANCOVA) were used to assess between-group differences in the modelled changes from baseline to Week 12.|Mean Difference (Final Values)|-2.51|STANDARD_ERROR_OF_MEAN|1.072||0.0209|TWO_SIDED|95.0|-4.64|-0.39||p-value was nominal and not adjusted.|ANCOVA||Mean difference (BI 409306 25 mg twice daily (BID) minus Placebo matching BI 409306)|The dependent variable was the change from the baseline score at Week 12. The model included fixed, categorical covariates of treatment as well as fixed continuous covariates of baseline score.|The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences|-0.39|-4.64|0.0209
72542459|NCT00106028|144614678|SUPERIORITY_OR_OTHER||Mean Difference (Net)|31.675|||<|0.0001||95.0|21.051|42.3|||ANCOVA|LS means and p-value are from ANCOVA model adjusted for baseline and fixed effects for age group, treatment and pooled center for post-baseline.||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.||42.300|21.051|<0.0001
72623992|NCT02231580|144778419|SUPERIORITY_OR_OTHER||GLS mean ratio|1.045|||=|0.6777|TWO_SIDED|90.0|0.875|1.248|||MMRM|||Right finger duration of TD statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||1.248|0.875|=0.6777
72623993|NCT02231580|144778420|SUPERIORITY_OR_OTHER||GLS mean ratio|1.618|||=|0.0326|TWO_SIDED|90.0|1.124|2.331|||MMRM|||Left finger IPI variability statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||2.331|1.124|=0.0326
72623994|NCT02231580|144778420|SUPERIORITY_OR_OTHER||GLS mean ratio|0.886|||=|0.6016|TWO_SIDED|90.0|0.605|1.299|||MMRM|||Right finger IPI variability statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||1.299|0.605|=0.6016
72401950|NCT00335972|144311253|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.9|||<|0.001|TWO_SIDED|97.5|-2.8|-0.9||Bonferroni correction was used for superiority testing since superiority on either hemodynamics or pain control would be interpreted as Dex better than Remi (alpha=0.0125 = 0.025/2, 97.5% CI).|repeated measures ANOVA model||mean difference: dexmedetomidine arm - remifentanil arm|superiority test||-0.9|-2.8|<0.001
72401951|NCT00335972|144311254|NON_INFERIORITY_OR_EQUIVALENCE|Sample size was based on being able to detect noninferiority on both analgesia (pain score and opioids) and hemodynamic responses, and superiority on at least one of them with 90% power and significance level of 0.025 for each of noninferiority and superiority.we needed a maximum of N= 65 per group. We assumed for opioids that the coefficient of variation (SD/mean) was about 0.4, resulting in a similar sample size (64/group) with noninferiority deltas of 20% of the observed mean|Mean Difference (Net)|-5.0|||<|0.001|TWO_SIDED|95.0|-10.0|-5.0||noninferiority confidence intervals are 95% (alpha of 0.05/2=0.025 in direction of interest)|Wilcoxon (Mann-Whitney)||mean difference: Dexmedetomidine arm - Remifentanil|||-5|-10|<0.001
72401952|NCT00335972|144311254|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.0|||<|0.001|TWO_SIDED|97.5|-10.0|-3.0||Bonferroni correction was used for superiority testing since superiority on either hemodynamics or pain control would be interpreted as Dex better than Remi (alpha=0.0125 = 0.025/2, 97.5% CI)|repeated measures ANOVA model||mean difference: dexmedetomidine arm - remifentanil arm|superiority||-3|-10|<0.001
72401953|NCT03965962|144311255|NON_INFERIORITY|The two-sided 95 percent (%) confidence interval (CI) was calculated based on the Wilson score method without continuity correction. Non-inferiority was demonstrated if the lower limit of the 95% CI of the difference of the percentages between the test group (Group 1) and control group (Group 2) was greater than (\>) -5% at Day 28.|Difference in Percentage|-0.42|||||TWO_SIDED|95.0|-2.33|4.35||||||||4.35|-2.33|
72401954|NCT03965962|144311255|NON_INFERIORITY|The two-sided 95 % CI was calculated based on the Wilson score method without continuity correction. Non-inferiority was demonstrated if the lower limit of the 95% CI of the difference of the percentages between the test group (Group 1) and control group (Group 3) was \> -5% at Day 28.|Difference in Percentage|0.86|||||TWO_SIDED|95.0|-1.32|6.5||||||||6.50|-1.32|
72401955|NCT02039674|144311266|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentages|26.3||||0.0016|TWO_SIDED|95.0|8.9|42.1|||Miettinen & Nurminen Method|||||42.1|8.9|0.0016
72401956|NCT02039674|144311267|SUPERIORITY|||||||0.0858|||||||Exact binomial distribution for testing|HO: ORR ≤20% versus H1: ORR \>20%||||||0.0858
72401957|NCT02039674|144311269|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.54||||0.00252|TWO_SIDED|95.0|0.35|0.83|||Log Rank|One-sided p-value based on log-rank test||||0.83|0.35|0.00252
72401958|NCT02039674|144311270|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.71||||0.06762|TWO_SIDED|95.0|0.45|1.12|||Log Rank|One-sided p-value based on log-rank test||||1.12|0.45|0.06762
72481715|NCT02240693|144490402|SUPERIORITY|H0: The dose group with the peak response in the respective model Mean NTB response = Mean NTB response of placebo.|Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.056||0.8694|TWO_SIDED|95.0|-0.101|0.12||p-value was nominal and not adjusted.|Mixed Model Repeated Measurement (MMRM)|Kenward-Roger was used to model degrees of freedom.|Mean difference (BI 409306 10 milligram (mg) once daily (QD) minus Placebo matching BI 409306)|"Mixed Model Repeated Measurement (MMRM) includes fixed, categorical effects of treatment, visit, current Acetylcholine Esterase Inhibitor (AChEI) use (Yes, No), and treatment-by-visit interaction, as well as the continuous fixed covariates of baseline, and baseline-by-visit interaction.~The study identifier is also a categorical covariate for the twin studies analyses."|The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|0.120|-0.101|0.8694
72481716|NCT02240693|144490402|SUPERIORITY|H0: The dose group with the peak response in the respective model Mean NTB response = Mean NTB response of placebo.|Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.057||0.9512|TWO_SIDED|95.0|-0.116|0.109||p-value was nominal and not adjusted.|Mixed Model Repeated Measurement (MMRM)|Kenward-Roger was used to model degrees of freedom.|Mean difference (BI 409306 25 mg QD minus Placebo matching BI 409306)|"Mixed Model Repeated Measurement (MMRM) includes fixed, categorical effects of treatment, visit, current Acetylcholine Esterase Inhibitor (AChEI) use (Yes, No), and treatment-by-visit interaction, as well as the continuous fixed covariates of baseline, and baseline-by-visit interaction.~The study identifier is also a categorical covariate for the twin studies analyses."|The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|0.109|-0.116|0.9512
72566828|NCT02312713|144664441|NON_INFERIORITY|Since there were not sufficient data in prior literature to specific an a priori non-inferiority margin, for this and other secondary outcomes we based conclusions and discussions on magnitude of differences between the group, descriptively. This strategy was specified in the protocol.|Mean Difference (Final Values)|0.23||||0.49|TWO_SIDED|95.0|-0.43|0.89|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Internet Based Exercise Training at 4 months.||0.89|-0.43|0.49
72401959|NCT05497284|144311272|OTHER|Probability (LTP001 is better than placebo)|Slope|-2.6|STANDARD_DEVIATION|2.07|||TWO_SIDED|80.0|-6.9|1.3||Probability that LTP001 is better than placebo is 10.3%|Baysesian random slope model|Bayesian random slope model to assess the difference in reduction rate (slope) in years between the treatment group and placebo group.||||1.3|-6.9|
72401960|NCT00567892|144311289|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.0||||0.944|TWO_SIDED|95.0|-6.0|4.0||All statistical tests were two-sided and were evaluated at the α = 0.05 level of significance.|Wilcoxon signed rank test|Since the assumptions of parametric tests were not met we used non-parametric tests for the analysis.||The null hypothesis for this study was the difference between the change in THI score due to active rTMS treatment and the change in THI score due to rTMS sham was not different from 0.||4|-6|0.944
72401961|NCT00567892|144311289|SUPERIORITY_OR_OTHER||Median Difference (Net)|-4.0||||0.674|TWO_SIDED|95.0|-9.0|10.0|||Wilcoxon signed rank test|The assumptions of parametric tests were not met.|All statistical tests were two-sided and were evaluated at the α = 0.05 level of significance.|The null hypothesis for this study was the difference between the change in THI score due to 4 weeks active rTMS treatment and the change in THI score due to 4 weeks rTMS sham was not different from 0.||10|-9|0.674
72401962|NCT01698463|144311297|OTHER||||||<|0.05||||||\<0.05 (threshold for significance).|Wilcoxon (Mann-Whitney)|||||||<0.05
72401963|NCT00004888|144311299|SUPERIORITY_OR_OTHER||Overall Response Rate|0.474|||||TWO_SIDED|95.0|0.31|0.642||||||||0.642|0.31|
72401964|NCT00004888|144311299|SUPERIORITY_OR_OTHER||Overall Response Rate|0.457|||||TWO_SIDED|95.0|0.309|0.61||||||||0.61|0.309|
72401965|NCT02174848|144311321|SUPERIORITY|||||||0.05|||||||t-test, 2 sided|||This comparison is for the initial study, during which patients in the placebo-DFP group received placebo and patients in the DFP-DFP group received deferiprone.||||0.0500
72401966|NCT02174848|144311321|SUPERIORITY|||||||0.9781|||||||t-test, 2 sided|||This comparison is for the extension study, during which patients in both groups received deferiprone.||||0.9781
72401967|NCT02174848|144311322|SUPERIORITY|||||||0.0206|||||||paired t-test|||||||0.0206
72401968|NCT02174848|144311323|SUPERIORITY|||||||0.2684|||||||paired t-test|||||||0.2684
72401969|NCT02174848|144311324|SUPERIORITY|||||||0.0821|||||||t-test, 2 sided|||This comparison is for the initial study, during which patients in the placebo-DFP group received placebo and patients in the DFP-DFP group received deferiprone||||0.0821
72401970|NCT02174848|144311324|SUPERIORITY|||||||0.5885|||||||t-test, 2 sided|||For the placebo-DFP group, the comparison is of the scores at the start vs. the end of the extension study; for the DFP-DFP group, the comparison is of the scores at the start vs. the end of the initial study||||0.5885
72401971|NCT02174848|144311325|SUPERIORITY|||||||0.3306|||||||t-test, 2 sided|||||||0.3306
72401972|NCT00644969|144311345|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.74||||0.0457|TWO_SIDED|95.0|1.03|21.78|||Regression, Logistic|||||21.78|1.03|0.0457
72401973|NCT00644969|144311346|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.18||||0.0901|TWO_SIDED|95.0|0.75|50.71|||Regression, Logistic|||||50.71|0.75|0.0901
72481717|NCT02240693|144490402|SUPERIORITY|H0: The dose group with the peak response in the respective model Mean NTB response = Mean NTB response of placebo.|Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.056||0.9321|TWO_SIDED|95.0|-0.105|0.115||p-value was nominal and not adjusted.|Mixed Model Repeated Measurement (MMRM)|Kenward-Roger was used to model degrees of freedom.|Mean difference (BI 409306 50 mg QD minus Placebo matching BI 409306)|"Mixed Model Repeated Measurement (MMRM) includes fixed, categorical effects of treatment, visit, current Acetylcholine Esterase Inhibitor (AChEI) use (Yes, No), and treatment-by-visit interaction, as well as the continuous fixed covariates of baseline, and baseline-by-visit interaction.~The study identifier is also a categorical covariate for the twin studies analyses."|The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences|0.115|-0.105|0.9321
72481718|NCT02240693|144490402|SUPERIORITY|H0: The dose group with the peak response in the respective model Mean NTB response = Mean NTB response of placebo.|Mean Difference (Final Values)|-0.09|STANDARD_ERROR_OF_MEAN|0.057||0.1288|TWO_SIDED|95.0|-0.199|0.025||p-value was nominal and not adjusted.|Mixed Model Repeated Measurement (MMRM)|Kenward-Roger was used to model degrees of freedom.|Mean difference (BI 409306 25 mg twice daily (BID) minus Placebo matching BI 409306)|"Mixed Model Repeated Measurement (MMRM) includes fixed, categorical effects of treatment, visit, current Acetylcholine Esterase Inhibitor (AChEI) use (Yes, No), and treatment-by-visit interaction, as well as the continuous fixed covariates of baseline, and baseline-by-visit interaction.~The study identifier is also a categorical covariate for the twin studies analyses."|The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences|0.025|-0.199|0.1288
72566829|NCT02312713|144664441|NON_INFERIORITY|Since there were not sufficient data in prior literature to specific an a priori non-inferiority margin, for this and other secondary outcomes we based conclusions and discussions on magnitude of differences between the group, descriptively. This strategy was specified in the protocol.|Mean Difference (Final Values)|0.0||||0.99|TWO_SIDED|95.0|-0.77|0.78|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Internet-Based Exercise Training at 12 months.||0.78|-0.77|0.99
72401974|NCT00644969|144311347|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.73||||0.1524|TWO_SIDED|95.0|0.82|3.68|||Regression, Logistic|||Week 12||3.68|0.82|0.1524
72401975|NCT00644969|144311347|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.96||||0.9235|TWO_SIDED|95.0|0.45|2.05|||Regression, Logistic|||Week 24||2.05|0.45|0.9235
72401976|NCT00644969|144311348|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.65||||0.0077|TWO_SIDED|95.0|-6.32|-0.99|||ANCOVA||Least squares mean difference|Week 12 treatment difference||-0.99|-6.32|0.0077
72401977|NCT00644969|144311348|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.23||||0.9022|TWO_SIDED|95.0|-3.99|3.52|||ANCOVA||Least squares mean difference|Week 24 treatment difference||3.52|-3.99|0.9022
72401978|NCT02515942|144311351|SUPERIORITY|Least squares mean for change from baseline from ANCOVA model with treatment, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal), baseline lesion size as covariates after multiple imputations.|Treatment Effect|-0.35||||0.0636|TWO_SIDED|80.0|-0.64|-0.06|||ANCOVA|||||-0.06|-0.64|0.0636
72401979|NCT02515942|144311351|SUPERIORITY||Treatment Effect|-0.29||||0.1019|TWO_SIDED|80.0|-0.59|0.0|||ANCOVA|||Least squares mean for change from baseline from ANCOVA model with treatment, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal), baseline lesion size as covariates after multiple imputations.||0.00|-0.59|0.1019
72401980|NCT02515942|144311351|SUPERIORITY||Treatment Effect|0.06||||0.5987|TWO_SIDED|80.0|-0.24|0.35|||ANCOVA|||Least squares mean for change from baseline from ANCOVA model with treatment, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal), baseline lesion size as covariates after multiple imputations.||0.35|-0.24|0.5987
72401981|NCT02515942|144311352|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|0.0||||0.5029|TWO_SIDED|80.0|-0.11|0.11|||Mixed Models Analysis|||Change from baseline at Day 85||0.11|-0.11|0.5029
72401982|NCT02515942|144311352|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|0.04||||0.682|TWO_SIDED|80.0|-0.07|0.14|||Mixed Models Analysis|||Change from baseline at Day 85||0.14|-0.07|0.6820
72401983|NCT02515942|144311352|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|0.04||||0.6826|TWO_SIDED|80.0|-0.07|0.14|||Mixed Models Analysis|||Change from baseline at Day 85||0.14|-0.07|0.6826
72481719|NCT02240693|144490402|SUPERIORITY|H0: The dose group with the peak response in the respective model Mean NTB response = Mean NTB response of placebo.|Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.041||0.6492|TWO_SIDED|95.0|-0.098|0.061||p-value was nominal and not adjusted.|Mixed Model Repeated Measurement (MMRM)|Kenward-Roger was used to model degrees of freedom.|Mean difference (Pooled BI 409306 minus Placebo matching BI 409306)|Mixed Model Repeated Measurement (MMRM) includes fixed, categorical effects of treatment, visit, current Acetylcholine Esterase Inhibitor (AChEI) use (Yes, No), and treatment-by-visit interaction, as well as the continuous fixed covariates of baseline, and baseline-by-visit interaction. The study identifier is also a categorical covariate for the twin studies analyses.|The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences|0.061|-0.098|0.6492
72481720|NCT01585987|144490403|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.439||||0.0972|TWO_SIDED|80.0|1.085|1.908||Significance level used: 0.2|Log Rank||The hazard ratio and its associated two-sided 80% confidence interval (CI) was estimated via a stratified Cox model with treatment arm as the only covariate in the model|||1.908|1.085|0.0972
72481721|NCT01585987|144490404|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.588||||0.0336|TWO_SIDED|80.0|1.199|2.103||Significance level used: 0.2|Log Rank|||||2.103|1.199|0.0336
72481722|NCT01585987|144490405|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.874||||0.6433|TWO_SIDED|80.0|0.602|1.269||Significance level used: 0.2|Log Rank||HR was based on a stratified Cox proportional hazards model with treatment arm as the only covariate in the model.|||1.269|0.602|0.6433
72481723|NCT01585987|144490407|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.0549||||0.3686|TWO_SIDED|80.0|0.7009|47.6447||Significance level used: 0.2|Cochran-Mantel-Haenszel|||||47.6447|0.7009|0.3686
72481724|NCT00413972|144490413|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||ANOVA|||||||<.0001
72481725|NCT00413972|144490413|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||ANOVA|||||||<.0001
72481726|NCT00413972|144490413|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||ANOVA|||||||<.0001
72481727|NCT01783041|144490417|OTHER||||||<|0.05||||||These are calculated p values.|ANOVA|Differences in continuous and categorical variables were compared using ANOVA and either Chi square test or Fisher's exact test, respectively.||||||<0.05
72481728|NCT01783041|144490418|OTHER||||||<|0.05||||||These are calculated p values.|Wilcoxon (Mann-Whitney)|This analysis applies to all sub-scales that were compared between the 2 study groups.||||||<0.05
72481729|NCT01783041|144490419|OTHER||||||<|0.05||||||Reported p values have been calculated.|t-test, 2 sided|Differences between the groups were analyzed using a two sided t-test.||||||<0.05
72481730|NCT01783041|144490420|OTHER||||||<|0.05||||||These are calculated p values.|ANOVA|Differences in continuous and categorical variables were compared using ANOVA and either Chi square test or Fisher's exact test, respectively.||||||<0.05
72481731|NCT02092220|144490426|SUPERIORITY||Mean Difference (Final Values)|-20.28|STANDARD_DEVIATION|24.59|<|0.0001|TWO_SIDED|95.0|-28.0|-12.56||Repeated measures model.|t-test, 2 sided||Bionic Pancreas Arm - Usual Care Arm|||-12.56|-28.00|<0.0001
72481732|NCT02092220|144490427|SUPERIORITY||Mean Difference (Final Values)|1.3|||<|0.0001|TWO_SIDED|95.0|0.8|1.8||Repeated measures model.|t-test, 2 sided|||||1.8|0.8|<0.0001
72481733|NCT01231516|144490487|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority of DTG 50 mg and RAL at Week 48 can be concluded if the lower bound of a two-sided 95% confidence interval (CI) for the difference in percentages (DTG - RAL) is greater than -12%. If non-inferiority were established, superiority would be tested at the nominal 5% level based on a pre-specified testing procedure.|Difference in percentage|7.4||||0.03|TWO_SIDED|95.0|0.7|14.2||P-value is for test of superiority.|Cochran-Mantel-Haenszel|Adjusted difference in proportion which is based on the difference in percentage, adjusted for Baseline (BL) stratification factors.|Analysis was adjusted for BL stratification factors: HIV-1 RNA (\<=50000 versus \[vs\]\>50000 c/mL), darunavir-ritonavir use without primary protease inhibitor mutations (yes vs no), and phenotypic susceptibility score (2 vs \<2) to background regimen.|||14.2|0.7|0.030
72481734|NCT03170154|144490503|OTHER||1-sided 95% Upper CL|99.99|||||ONE_SIDED||||||||Historical comparison to EN ISO 11979-7:2014: SPE rate of at least 92.5 for the AAS at 12 months.|||||
72481735|NCT03170154|144490504|OTHER||1-sided 95% Upper CL|99.98|||||ONE_SIDED|95.0|||||||Historical comparison to EN ISO 11979-7:2014: SPE rate of at least 96.7 for the BAS at 12 months.|||||
72481736|NCT05245097|144490516|OTHER|For the multiple imputation, a total of 50 imputed datasets will be calculated (Graham et al.). Fully conditional specification (FCS) discriminant function method will be used to impute missing primary endpoint using the baseline covariates of age, sex, race, ethnicity, mobility level, and BIMS Score. The FCS logistic method was replaced with the FCS discriminant function method due to a quasi-separation caused by only one observed primary endpoint event in the treatment group.||||||0.004||||||The null hypothesis was tested at a one-sided 0.025 level of significance using a logistic regression analysis to compare treatment groups while controlling for propensity score.|Regression, Logistic|||||||0.004
72481737|NCT05245097|144490517|OTHER|||||||0.003||||||The hip fracture due to fall rate was compared between treatment groups using firth logistic regression while controlling for propensity score. A one-sided 0.025 level of significance was used.|Regression, Logistic|||||||0.003
72481738|NCT05245097|144490517|SUPERIORITY|||||||0.003|||||||Regression, Logistic|||||||0.003
72481739|NCT05245097|144490518|SUPERIORITY|||||||0.001||||||The emergency department visit due to fall rate was compared between treatment groups using firth logistic regression while controlling for propensity score. A one-sided 0.025 level of significance was used.|Regression, Logistic|Subjects with multiple ED visits due to falls are only counted once.||||||0.001
72481740|NCT05245097|144490519|SUPERIORITY|||||||0.003||||||The hospitalization due to fall rate was compared between treatment groups using firth logistic regression while controlling for propensity score. A one-sided 0.025 level of significance was used.|Regression, Logistic|Subjects with multiple hospitalizations due to falls are only counted once.||||||0.003
72481741|NCT00692978|144490553|EQUIVALENCE|Log transformed parametric ANOVA|||||<|0.05||||||calculated|ANOVA|||||||<0.05
72481742|NCT00607022|144490554|OTHER|Kruskal-Wallis values between each loading group and for Wilcoxon Signed Rank for measures on the mesial vs buccal side of the implant.|||||>|0.05||||||0.0501 \< p \< 0.9797|Kruskal-Wallis|Kruskal-Wallis test evaluated ISQ at each time point..||Comparison between loading groups at 16 weeks - loading at baseline, Loading at 6 weeks, and loading at 12 weeks. Scores for all groups were compared at 16 weeks from implant placement..||||>0.05
72401984|NCT02515942|144311352|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-0.12||||0.1545|TWO_SIDED|80.0|-0.28|0.03|||Mixed Models Analysis|||Change from baseline at Day 169||0.03|-0.28|0.1545
72510519|NCT01204658|144551317|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was supported if one could rule out an increase in terms of percentage of subjects (10PP-LD Group minus Synflorix Group) above 5% + half the incidence in the Synflorix Group (= null hypothesis) as shown by a 1-sided P-value \< 5%.|Difference in percentage|0.0||||0.003|TWO_SIDED|95.0|-2.61|2.57||1-sided P-value computed using Kem Philips' approach for ruling out an increase in % subjects with fever \> 40.0°C and causal relationship to vaccination \> the boundary expressed as 5% + 0.5\*rate in the Synflorix group.|Kem Phillip's statistical test|||Non-inferiority of 10PP-LD vaccine vs Synflorix™ vaccine post dose 2 was assessed by computing the difference in percentages of subjects reporting Grade 3 fever causally related to dose 2 vaccination in the 10PP-LD Group minus Synflorix Group.||2.57|-2.61|0.003
72510520|NCT01204658|144551317|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was supported if one could rule out an increase in terms of percentage of subjects (10PP-LD Group minus Synflorix Group) above 5% + half the incidence in the Synflorix Group (= null hypothesis) as shown by a 1-sided P-value \< 5%.|Difference in percentage|0.0||||0.003|TWO_SIDED|95.0|-2.62|2.57||1-sided P-value computed using Kem Philips' approach for ruling out an increase in % subjects with fever \> 40.0°C and causal relationship to vaccination \> the boundary expressed as 5% + 0.5\*rate in the Synflorix group.|Kem Phillip's statistical test|||Non-inferiority of 10PP-LD vaccine vs Synflorix™ vaccine post dose 3 was assessed by computing the difference in percentages of subjects reporting Grade 3 fever causally related to dose 3 vaccination in the 10PP-LD Group minus Synflorix Group.||2.57|-2.62|0.003
72510521|NCT01204658|144551317|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was supported if one could rule out an increase in terms of percentage of subjects (10PP-LD Group minus Synflorix Group) above 5% + half the incidence in the Synflorix Group (= null hypothesis) as shown by a 1-sided P-value \< 5%.|Difference in percentage|0.0||||0.003|TWO_SIDED|95.0|-2.61|2.57||1-sided P-value computed using Kem Philips' approach for ruling out an increase in % subjects with fever \> 40.0°C and causal relationship to vaccination \> the boundary expressed as 5% + 0.5\*rate in the Synflorix group.|Kem Phillip's statistical test|||Non-inferiority of 10PP-LD vaccine vs Synflorix™ vaccine across doses was assessed by computing the difference in percentages of subjects reporting Grade 3 fever causally related to vaccination, across doses, in the 10PP-LD Group minus Synflorix Group.||2.57|-2.61|0.003
72510522|NCT01204658|144551318|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was supported if one could rule out an increase in terms of percentage of subjects (10PP-HD Group minus Synflorix Group) above 5% + half the incidence in the Synflorix Group (= null hypothesis) as shown by a 1-sided P-value \< 5%.|Difference in percentage|0.0||||0.003|TWO_SIDED|95.0|-2.61|2.64||1-sided P-value computed using Kem Philips' approach for ruling out an increase in % subjects with fever \> 40.0°C and causal relationship to vaccination \> the boundary expressed as 5% + 0.5\*rate in the Synflorix group.|Kem Phillip's statistical test|||Non-inferiority of 10PP-HD vaccine vs Synflorix™ vaccine post dose 1 was assessed by computing the difference in percentages of subjects reporting Grade 3 fever causally related to dose 1 vaccination in the 10PP-HD Group minus Synflorix Group.||2.64|-2.61|0.003
72401985|NCT02515942|144311352|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-0.13||||0.1398|TWO_SIDED|80.0|-0.29|0.02|||Mixed Models Analysis|||Change from baseline at Day 169||0.02|-0.29|0.1398
72401986|NCT02515942|144311352|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-0.01||||0.4717|TWO_SIDED|80.0|-0.16|0.14|||Mixed Models Analysis|||Change from baseline at Day 169||0.14|-0.16|0.4717
72510523|NCT01204658|144551318|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was supported if one could rule out an increase in terms of percentage of subjects (10PP-HD Group minus Synflorix Group) above 5% + half the incidence in the Synflorix Group (= null hypothesis) as shown by a 1-sided P-value \< 5%.|Difference in percentage|0.0||||0.003|TWO_SIDED|95.0|-2.61|2.64||1-sided P-value computed using Kem Philips' approach for ruling out an increase in % subjects with fever \> 40.0°C and causal relationship to vaccination \> the boundary expressed as 5% + 0.5\*rate in the Synflorix group.|Kem Phillip's statistical test|||Non-inferiority of 10PP-HD vaccine vs Synflorix™ vaccine post dose 2 was assessed by computing the difference in percentages of subjects reporting Grade 3 fever causally related to dose 2 vaccination in the 10PP-HD Group minus Synflorix Group.||2.64|-2.61|0.003
72510524|NCT01204658|144551318|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was supported if one could rule out an increase in terms of percentage of subjects (10PP-HD Group minus Synflorix Group) above 5% + half the incidence in the Synflorix Group (= null hypothesis) as shown by a 1-sided P-value \< 5%.|Difference in percentage|0.0||||0.003|TWO_SIDED|95.0|-2.63|2.66||1-sided P-value computed using Kem Philips' approach for ruling out an increase in % subjects with fever \> 40.0°C and causal relationship to vaccination \> the boundary expressed as 5% + 0.5\*rate in the Synflorix group.|Kem Phillip's statistical test|||Non-inferiority of 10PP-HD vaccine vs Synflorix™ vaccine post dose 3 was assessed by computing the difference in percentages of subjects reporting Grade 3 fever causally related to dose 3 vaccination in the 10PP-HD Group minus Synflorix Group.||2.66|-2.63|0.003
72401987|NCT02515942|144311352|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-0.25||||0.053|TWO_SIDED|80.0|-0.45|-0.05|||Mixed Models Analysis|||Change from baseline at Day 253||-0.05|-0.45|0.0530
72401988|NCT02515942|144311352|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-0.17||||0.1386|TWO_SIDED|80.0|-0.37|0.03|||Mixed Models Analysis|||Change from baseline at Day 253||0.03|-0.37|0.1386
72401989|NCT02515942|144311352|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|0.08||||0.7087|TWO_SIDED|80.0|-0.11|0.27|||Mixed Models Analysis|||Change from baseline at Day 253||0.27|-0.11|0.7087
72481743|NCT03282240|144490558|NON_INFERIORITY|Non-inferiority of GMTs was concluded if the lower limit of the 2-sided 95% CI of the ratio of GMTs between groups is \> 0.667 for each of the comparisons.|GMT Ratio (QIV-HD/TIV-HDs)|1.08|||||TWO_SIDED|95.0|0.958|1.224||||||B Victoria: The 2-sided 95% confidence interval (CI) was based on the Student t-distribution of logarithmic transformation of the individual titers. Antilog transformations were applied to the results.||1.224|0.958|
72481744|NCT03282240|144490558|NON_INFERIORITY|Non-inferiority of GMTs was concluded if the lower limit of the 2-sided 95% CI of the ratio of GMTs between groups is \> 0.667 for each of the comparisons.|GMT Ratio (QIV-HD/TIV-HDs)|1.0|||||TWO_SIDED|95.0|0.881|1.129||||||B Yamagata: The 2-sided 95% CI was based on the Student t-distribution of logarithmic transformation of the individual titers. Antilog transformations were applied to the results.||1.129|0.881|
72481745|NCT03282240|144490558|NON_INFERIORITY|Non-inferiority of GMTs was concluded if the lower limit of the 2-sided 95% CI of the ratio of GMTs between groups is \> 0.667 for each of the comparisons.|GMT Ratio (QIV-HD/TIV-HDs)|0.83|||||TWO_SIDED|95.0|0.744|0.932||||||A/H1N1: The 2-sided 95% CI was based on the Student t-distribution of logarithmic transformation of the individual titers. Antilog transformations were applied to the results.||0.932|0.744|
72481746|NCT03282240|144490558|NON_INFERIORITY|Non-inferiority of GMTs was concluded if the lower limit of the 2-sided 95% CI of the ratio of GMTs between groups is \> 0.667 for each of the comparisons.|GMT Ratio (QIV-HD/TIV-HDs)|0.95|||||TWO_SIDED|95.0|0.842|1.066||||||A/H3N2: The 2-sided 95% CI was based on the Student t-distribution of logarithmic transformation of the individual titers. Antilog transformations were applied to the results.||1.066|0.842|
72481747|NCT03282240|144490559|NON_INFERIORITY|Non-inferiority in seroconversion was concluded if the lower limit of the 2-sided 95% CI of the differences of seroconversion rates between groups is \> -10%.|Difference in Percentage|-2.41|||||TWO_SIDED|95.0|-7.66|2.7||||||B Victoria: The 2-sided 95% CI for the difference is based on the Wilson score method without continuity correction.||2.70|-7.66|
72481748|NCT03282240|144490559|NON_INFERIORITY|Non-inferiority in seroconversion was concluded if the lower limit of the 2-sided 95% CI of the differences of seroconversion rates between groups is \> -10%.|Difference in Percentage|-1.75|||||TWO_SIDED|95.0|-7.04|3.53||||||B Yamagata: The 2-sided 95% CI for the difference is based on the Wilson score method without continuity correction.||3.53|-7.04|
72481749|NCT03282240|144490559|NON_INFERIORITY|Non-inferiority in seroconversion was concluded if the lower limit of the 2-sided 95% CI of the differences of seroconversion rates between groups is \> -10%.|Difference in Percentage|-0.71|||||TWO_SIDED|95.0|-4.83|3.42||||||A/H3N2: The 2-sided 95% CI for the difference is based on the Wilson score method without continuity correction.||3.42|-4.83|
72481750|NCT03282240|144490559|NON_INFERIORITY|Non-inferiority in seroconversion was concluded if the lower limit of the 2-sided 95% CI of the differences of seroconversion rates between groups is \> -10%.|Difference in Percentage|-3.27|||||TWO_SIDED|95.0|-7.37|0.86||||||A/H1N1: The 2-sided 95% CI for the difference is based on the Wilson score method without continuity correction.||0.86|-7.37|
72481751|NCT03282240|144490560|SUPERIORITY|Superiority in GMTs was observed if the lower limit of the 2-sided 95% CI of the ratio of GMTs between groups was \> 1.5 for comparison group.|GMT Ratio (QIV-HD/TIV-HDs)|2.04|||||TWO_SIDED|95.0|1.804|2.315||||||The 2-sided 95% CI is based on the Student t-distribution of logarithmic transformation of the individual titers. Antilog transformations were applied to the results.||2.315|1.804|
72481752|NCT03282240|144490560|SUPERIORITY|Superiority in GMTs was observed if the lower limit of the 2-sided 95% CI of the ratio of GMTs between groups was \> 1.5 for comparison group.|GMT Ratio (QIV-HD/TIV-HDs)|2.03|||||TWO_SIDED|95.0|1.802|2.288||||||The 2-sided 95% CI is based on the Student t-distribution of logarithmic transformation of the individual titers. Antilog transformations were applied to the results.||2.288|1.802|
72481753|NCT03282240|144490562|SUPERIORITY|Superiority in seroconversion was observed if the lower limit of the 2-sided 95% CI of the difference of seroconversion rates between groups is \> 10% for each applicable comparison.|Difference in Percentage|29.27|||||TWO_SIDED|95.0|24.78|33.29||||||B Yamagata: The 2-sided 95% CI for the difference was based on the Wilson score method without continuity correction.||33.29|24.78|
72510525|NCT01204658|144551318|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was supported if one could rule out an increase in terms of percentage of subjects (10PP-HD Group minus Synflorix Group) above 5% + half the incidence in the Synflorix Group (= null hypothesis) as shown by a 1-sided P-value \< 5%.|Difference in percentage|0.0||||0.003|TWO_SIDED|95.0|-2.61|2.64||1-sided P-value computed using Kem Philips' approach for ruling out an increase in % subjects with fever \> 40.0°C and causal relationship to vaccination \> the boundary expressed as 5% + 0.5\*rate in the Synflorix group.|Kem Phillip's statistical test|||Non-inferiority of 10PP-HD vaccine vs Synflorix™ vaccine across doses was assessed by computing the difference in percentages of subjects reporting Grade 3 fever causally related to vaccination, across doses, in the 10PP-HD Group minus Synflorix Group.||2.64|-2.61|0.003
72510526|NCT04937816|144551345|OTHER||Hazard Ratio (HR)|1.0||||0.9946|TWO_SIDED|95.0|0.83|1.2|||Regression, Cox|Cox regression of time to first vascular AE. Cox regression model with terms for study, baseline diabetes status and treatment.|Comparison versus Placebo \[Treatment/ Placebo\].|Time to first vascular AE (SAF-M1)||1.20|0.83|0.9946
72401990|NCT02515942|144311354|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-2.72||||0.9243|TWO_SIDED|80.0|-5.15|-0.29|||Mixed Models Analysis|||Change from baseline at Day 2||-0.29|-5.15|0.9243
72481754|NCT03282240|144490562|SUPERIORITY|Superiority in seroconversion was observed if the lower limit of the 2-sided 95% CI of the difference of seroconversion rates between groups is \> 10% for each applicable comparison.|Difference in Percentage|20.78|||||TWO_SIDED|95.0|16.5|24.61||||||B Victoria: The 2-sided 95% CI for the difference was based on the Wilson score method without continuity correction.||24.61|16.5|
72481755|NCT03254485|144490574|SUPERIORITY||Least Squares Mean Difference|-0.3|||=|0.3681|TWO_SIDED|95.0|-0.95|0.35|||ANCOVA|||||0.35|-0.95|=0.3681
72481756|NCT03254485|144490575|SUPERIORITY||Least Squares Mean Difference|-16.74|||=|0.2817|TWO_SIDED|95.0|-47.38|13.9|||ANCOVA|||||13.90|-47.38|=0.2817
72481757|NCT03254485|144490576|SUPERIORITY||Least Squares Mean Difference|-0.297|||=|0.6508|TWO_SIDED|95.0|-1.591|0.997|||ANCOVA|||||0.997|-1.591|=0.6508
72481758|NCT02146326|144490578|SUPERIORITY|||||||0.8|||||||Mixed Models Analysis|||Mixed effects regression analysis was used to examine the BREATHE intervention effect on clinician burnout and patient processes, engagement, and outcomes as compared to MI after the intervention by adjusting for the baseline scores and the implementation site.||||0.80
72481759|NCT02146326|144490579|SUPERIORITY|||||||0.8|||||||Mixed Models Analysis|||Mixed effects regression analysis was used to examine the BREATHE intervention effect on clinician burnout and patient processes, engagement, and outcomes as compared to MI after the intervention by adjusting for the baseline scores and the implementation site.||||0.80
72481760|NCT02146326|144490580|SUPERIORITY|||||||0.54|||||||Mixed Models Analysis|||Mixed effects regression analysis was used to examine the BREATHE intervention effect on clinician burnout and patient processes, engagement, and outcomes as compared to MI after the intervention by adjusting for the baseline scores and the implementation site.||||0.54
72481761|NCT02146326|144490581|SUPERIORITY|||||||0.94|||||||Mixed Models Analysis|||Mixed effects regression analysis was used to examine the BREATHE intervention effect on clinician burnout and patient processes, engagement, and outcomes as compared to MI after the intervention by adjusting for the baseline scores and the implementation site.||||0.94
72481762|NCT02146326|144490582|SUPERIORITY|||||||0.96|||||||Mixed Models Analysis|||Mixed effects regression analysis was used to examine the BREATHE intervention effect on clinician burnout and patient processes, engagement, and outcomes as compared to MI after the intervention by adjusting for the baseline scores and the implementation site.||||0.96
72481763|NCT02146326|144490583|SUPERIORITY|||||||0.17|||||||Mixed Models Analysis|||Mixed effects regression analysis was used to examine the BREATHE intervention effect on clinician burnout and patient processes, engagement, and outcomes as compared to MI after the intervention by adjusting for the baseline scores and the implementation site.||||0.17
72481764|NCT02146326|144490584|SUPERIORITY|||||||0.47|||||||Mixed Models Analysis|||Mixed effects regression analysis was used to examine the BREATHE intervention effect on clinician burnout and patient processes, engagement, and outcomes as compared to MI after the intervention by adjusting for the baseline scores and the implementation site.||||0.47
72510527|NCT04937816|144551345|OTHER||Hazard Ratio (HR)|0.95||||0.7474|TWO_SIDED|95.0|0.72|1.27|||Regression, Cox|Cox regression of time to first vascular AE. Cox regression model with terms for study, baseline diabetes status and treatment.|Comparison versus placebo. \[Treatment/Placebo\].|Time to first vascular AE (SAF-M2)||1.27|0.72|0.7474
72510528|NCT04937816|144551345|OTHER||Hazard Ratio (HR)|1.03||||0.7943|TWO_SIDED|95.0|0.81|1.31|||Regression, Cox|Cox regression for time to first vascular AE on-treatment. Cox regression model with a term for treatment.|Comparison vs. Placebo \[Treatment / Placebo\]|Time to first vascular AE (Trial NCT01131676, all empagliflozin (10 and 25 mg vs. Placebo))||1.31|0.81|0.7943
72510529|NCT04937816|144551345|OTHER||Hazard Ratio (HR)|0.97||||0.8518|TWO_SIDED|95.0|0.69|1.36|||Regression, Cox|Cox regression for time to first vascular AE on-treatment. Cox regression model with terms for baseline diabetes status and treatment.|Comparison vs. Placebo \[Treatment / Placebo\].|Time to first vascular AE (Trial NCT03057951)||1.36|0.69|0.8518
72510530|NCT04937816|144551345|OTHER||Hazard Ratio (HR)|0.93||||0.766|TWO_SIDED|95.0|0.56|1.53|||Regression, Cox|Cox regression for time to first vascular AE on-treatment. Cox regression model with terms for baseline diabetes status and treatment.|Comparison vs Placebo \[Treatment/Placebo\]|Time to first vascular AE (Trial NCT03057977)||1.53|0.56|0.7660
72510531|NCT04937816|144551345|OTHER||Hazard Ratio (HR)|1.15||||0.3612|TWO_SIDED|95.0|0.85|1.55|||Regression, Cox|Cox regression of time to first diabetic foot related AE. Cox regression model with terms for study, baseline diabetes status and treatment.|Comparison versus placebo \[Treatment/Placebo\].|Time to first diabetic foot related AE (SAF-M1)||1.55|0.85|0.3612
72510532|NCT04937816|144551345|OTHER||Hazard Ratio (HR)|1.44||||0.161|TWO_SIDED|95.0|0.86|2.4|||Regression, Cox|Cox regression of time to first diabetic foot related AE. Cox regression model with terms for study, baseline diabetes status and treatment.|Comparison versus Placebo \[Treatment/Placebo\].|Time to first diabetic foot related AE (SAF-M2)||2.40|0.86|0.1610
72510533|NCT04937816|144551345|OTHER||Hazard Ratio (HR)|1.02||||0.9128|TWO_SIDED|95.0|0.71|1.47|||Regression, Cox|Cox regression for time to first diabetic foot related AE on treatment. Cox regression model with a term for treatment.|Comparison vs. Placebo \[Treatment/Placebo\]|Time to first diabetic foot related AE (Trial NCT01131676, all empagliflozin (10 and 25 mg) vs. Placebo)||1.47|0.71|0.9128
72481765|NCT02146326|144490585|SUPERIORITY|||||||0.6|||||||Mixed Models Analysis|||Mixed effects regression analysis was used to examine the BREATHE intervention effect on clinician burnout and patient processes, engagement, and outcomes as compared to MI after the intervention by adjusting for the baseline scores and the implementation site.||||0.60
72481766|NCT02146326|144490586|SUPERIORITY|||||||0.37|||||||Mixed Models Analysis|||Mixed effects regression analysis was used to examine the BREATHE intervention effect on clinician burnout and patient processes, engagement, and outcomes as compared to MI after the intervention by adjusting for the baseline scores and the implementation site.||||0.37
72481767|NCT02146326|144490587|SUPERIORITY|||||||0.83|||||||Mixed Models Analysis|||Mixed effects regression analysis was used to examine the BREATHE intervention effect on clinician burnout and patient processes, engagement, and outcomes as compared to MI after the intervention by adjusting for the baseline scores and the implementation site.||||0.83
72481768|NCT02146326|144490588|SUPERIORITY|||||||0.64|||||||Mixed Models Analysis|||Mixed effects regression analysis was used to examine the BREATHE intervention effect on clinician burnout and patient processes, engagement, and outcomes as compared to MI after the intervention by adjusting for the baseline scores and the implementation site.||||0.64
72510534|NCT04937816|144551345|OTHER||Hazard Ratio (HR)|0.81||||0.5276|TWO_SIDED|95.0|0.43|1.54|||Regression, Cox|Cox regression for time to first diabetic foot related AE. Cox regression model with terms for baseline diabetes status and treatment.|Comparison vs. Placebo \[Treatment/Placebo\]|Time to first diabetic foot related AE (Trial NCT03057951)||1.54|0.43|0.5276
72481769|NCT02146326|144490589|SUPERIORITY|||||||0.37|||||||Mixed Models Analysis|||Mixed effects regression analysis was used to examine the BREATHE intervention effect on clinician burnout and patient processes, engagement, and outcomes as compared to MI after the intervention by adjusting for the baseline scores and the implementation site.||||0.37
72481770|NCT02146326|144490590|SUPERIORITY|||||||0.13|||||||Mixed Models Analysis|||Mixed effects regression analysis was used to examine the BREATHE intervention effect on clinician burnout and patient processes, engagement, and outcomes as compared to MI after the intervention by adjusting for the baseline scores and the implementation site.||||0.13
72481771|NCT02146326|144490591|SUPERIORITY|||||||0.93|||||||Mixed Models Analysis|||Mixed effects regression analysis was used to examine the BREATHE intervention effect on clinician burnout and patient processes, engagement, and outcomes as compared to MI after the intervention by adjusting for the baseline scores and the implementation site.||||0.93
72481772|NCT02146326|144490592|SUPERIORITY|||||||0.11|||||||Mixed Models Analysis|||Mixed effects regression analysis was used to examine the BREATHE intervention effect on clinician burnout and patient processes, engagement, and outcomes as compared to MI after the intervention by adjusting for the baseline scores and the implementation site.||||0.11
72481773|NCT02146326|144490593|SUPERIORITY|||||||0.21|||||||Mixed Models Analysis|||Mixed effects regression analysis was used to examine the BREATHE intervention effect on clinician burnout and patient processes, engagement, and outcomes as compared to MI after the intervention by adjusting for the baseline scores and the implementation site.||||0.21
72481774|NCT02146326|144490595|SUPERIORITY|||||||0.17|||||||Mixed Models Analysis|||Mixed effects regression analysis was used to examine the BREATHE intervention effect on clinician burnout and patient processes, engagement, and outcomes as compared to MI after the intervention by adjusting for the baseline scores and the implementation site.||||0.17
72481775|NCT02146326|144490596|SUPERIORITY|||||||0.24|||||||Mixed Models Analysis|||||||0.24
72481776|NCT02146326|144490597|SUPERIORITY|||||||0.35|||||||Chi-squared|||||||0.35
72481777|NCT02146326|144490598|SUPERIORITY|||||||0.67|||||||Mixed Models Analysis|||Mixed effects regression analysis was used to examine the BREATHE intervention effect on patient processes, engagement, and outcomes as compared to MI after the intervention by adjusting for the baseline scores and the implementation site.||||0.67
72481778|NCT02146326|144490599|SUPERIORITY|||||||0.04|||||||Mixed Models Analysis|||Mixed effects regression analysis was used to examine the BREATHE intervention effect on patient processes, engagement, and outcomes as compared to MI after the intervention by adjusting for the baseline scores and the implementation site.||||0.04
72510535|NCT04937816|144551345|OTHER||Hazard Ratio (HR)|4.72||||0.0048|TWO_SIDED|95.0|1.6|13.87|||Regression, Cox|Cox regression for time to first diabetic foot related AE. Cox regression model with terms for baseline diabetes status and treatment.|Comparison vs Placebo \[Treatment / Placebo\]|Time to first diabetic foot related AE (Trial NCT03057977)||13.87|1.60|0.0048
72510536|NCT04937816|144551345|OTHER||Hazard Ratio (HR)|0.89||||0.1526|TWO_SIDED|95.0|0.77|1.04|||Regression, Cox|Cox regression of time to first infections potentially related to LLA's. Cox regression with terms for study, baseline diabetes status and treatment.|Comparison versus Placebo \[Treatment/Placebo\].|Time to first infections potentially related to LLA's (SAF-M1)||1.04|0.77|0.1526
72510537|NCT04937816|144551345|OTHER||Hazard Ratio (HR)|0.96||||0.743|TWO_SIDED|95.0|0.76|1.21|||Regression, Cox|Cox regression of time to first infection potentially related to LLA's. Cox regression with terms for study, baseline diabetes status and treatment.|Comparison versus Placebo \[Treatment/Placebo\].|Time to first infection potentially related to LLA's (SAF-M2)||1.21|0.76|0.7430
72510538|NCT04937816|144551345|OTHER||Hazard Ratio (HR)|0.85||||0.1049|TWO_SIDED|95.0|0.69|1.04|||Regression, Cox|Cox regression for infections potentially related to LLA-on treatment. Cox regression model with a term for treatment.|Comparison vs Placebo \[Treatment/Placebo\]|Time to first infections potentially related to LLA (Trial NCT01131676, all Empagliflozin (10 mg and 25 mg) vs. Placebo)||1.04|0.69|0.1049
72481779|NCT02146326|144490600|SUPERIORITY|||||||0.34|||||||Mixed Models Analysis|||Mixed effects regression analysis was used to examine the BREATHE intervention effect on patient processes, engagement, and outcomes as compared to MI after the intervention by adjusting for the baseline scores and the implementation site.||||0.34
72481780|NCT02146326|144490601|SUPERIORITY|||||||0.71|||||||Mixed Models Analysis|||Mixed effects regression analysis was used to examine the BREATHE intervention effect on patient processes, engagement, and outcomes as compared to MI after the intervention by adjusting for the baseline scores and the implementation site.||||0.71
72481781|NCT02146326|144490602|SUPERIORITY|||||||0.22|||||||Mixed Models Analysis|||Mixed effects regression analysis was used to examine the BREATHE intervention effect on patient processes, engagement, and outcomes as compared to MI after the intervention by adjusting for the baseline scores and the implementation site.||||0.22
72481782|NCT02146326|144490603|SUPERIORITY|||||||0.11|||||||Mixed Models Analysis|||Mixed effects regression analysis was used to examine the BREATHE intervention effect on patient processes, engagement, and outcomes as compared to MI after the intervention by adjusting for the baseline scores and the implementation site.||||0.11
72481783|NCT02146326|144490604|SUPERIORITY|||||||0.14|||||||Mixed Models Analysis|||Mixed effects regression analysis was used to examine the BREATHE intervention effect on patient processes, engagement, and outcomes as compared to MI after the intervention by adjusting for the baseline scores and the implementation site.||||0.14
72510539|NCT04937816|144551345|OTHER||Hazard Ratio (HR)|0.89||||0.395|TWO_SIDED|95.0|0.67|1.17|||Regression, Cox|Cox regression for infections potentially related to LLA on treatment. Cox regression model with terms for baseline diabetes status and treatment.|Comparison vs Placebo \[Treatment/Placebo\]|Time to first infections potentially related to LLA (Trial NCT03057951)||1.17|0.67|0.3950
72481784|NCT02146326|144490605|SUPERIORITY|||||||0.55|||||||Mixed Models Analysis|||Mixed effects regression analysis was used to examine the BREATHE intervention effect on patient processes, engagement, and outcomes as compared to MI after the intervention by adjusting for the baseline scores and the implementation site.||||0.55
72481785|NCT02146326|144490606|SUPERIORITY|||||||0.91|||||||Mixed Models Analysis|||Mixed effects regression analysis was used to examine the BREATHE intervention effect on patient processes, engagement, and outcomes as compared to MI after the intervention by adjusting for the baseline scores and the implementation site.||||0.91
72481786|NCT02146326|144490607|SUPERIORITY|||||||0.48|||||||Mixed Models Analysis|||Mixed effects regression analysis was used to examine the BREATHE intervention effect on patient processes, engagement, and outcomes as compared to MI after the intervention by adjusting for the baseline scores and the implementation site.||||0.48
72481787|NCT02146326|144490608|SUPERIORITY|||||||0.67|||||||Mixed Models Analysis|||Mixed effects regression analysis was used to examine the BREATHE intervention effect on patient processes, engagement, and outcomes as compared to MI after the intervention by adjusting for the baseline scores and the implementation site.||||0.67
72481788|NCT02146326|144490609|SUPERIORITY|||||||0.77|||||||Mixed Models Analysis|||Mixed effects regression analysis was used to examine the BREATHE intervention effect on patient processes, engagement, and outcomes as compared to MI after the intervention by adjusting for the baseline scores and the implementation site.||||0.77
72481789|NCT02146326|144490610|SUPERIORITY|||||||0.59|||||||Mixed Models Analysis|||Mixed effects regression analysis was used to examine the BREATHE intervention effect on patient processes, engagement, and outcomes as compared to MI after the intervention by adjusting for the baseline scores and the implementation site.||||0.59
72481790|NCT02146326|144490611|SUPERIORITY|||||||0.64|||||||Mixed Models Analysis|||Mixed effects regression analysis was used to examine the BREATHE intervention effect on patient processes, engagement, and outcomes as compared to MI after the intervention by adjusting for the baseline scores and the implementation site.||||0.64
72481791|NCT02146326|144490612|SUPERIORITY|||||||0.05|||||||Mixed Models Analysis|||Mixed effects regression analysis was used to examine the BREATHE intervention effect on patient processes, engagement, and outcomes as compared to MI after the intervention by adjusting for the baseline scores and the implementation site.||||0.05
72481792|NCT02146326|144490613|SUPERIORITY|||||||0.06|||||||Mixed Models Analysis|||Mixed effects regression analysis was used to examine the BREATHE intervention effect on patient processes, engagement, and outcomes as compared to MI after the intervention by adjusting for the baseline scores and the implementation site.||||0.06
72481793|NCT02146326|144490614|SUPERIORITY|||||||0.84|||||||Mixed Models Analysis|||Mixed effects regression analysis was used to examine the BREATHE intervention effect on patient processes, engagement, and outcomes as compared to MI after the intervention by adjusting for the baseline scores and the implementation site.||||0.84
72481794|NCT02146326|144490615|SUPERIORITY|||||||0.14|||||||Mixed Models Analysis|||Mixed effects regression analysis was used to examine the BREATHE intervention effect on patient processes, engagement, and outcomes as compared to MI after the intervention by adjusting for the baseline scores and the implementation site.||||0.14
72481795|NCT02146326|144490616|SUPERIORITY|||||||0.45|||||||Mixed Models Analysis|||Mixed effects regression analysis was used to examine the BREATHE intervention effect on patient processes, engagement, and outcomes as compared to MI after the intervention by adjusting for the baseline scores and the implementation site.||||0.45
72510540|NCT04937816|144551345|OTHER||Hazard Ratio (HR)|1.19||||0.4429|TWO_SIDED|95.0|0.76|1.87|||Regression, Cox|Cox regression for infections potentially related to LLA on-treatment. Cox regression model with terms for baseline diabetes status and treatment.|Comparison vs Placebo \[Treatment/Placebo\]|Time to first infections potentially related to LLA (Trial NCT03057977)||1.87|0.76|0.4429
72510541|NCT04937816|144551345|OTHER||Hazard Ratio (HR)|0.89||||0.3396|TWO_SIDED|95.0|0.7|1.13|||Regression, Cox|Cox regression of time to first wound infections. Cox regression with terms for study, baseline diabetes status and treatment.|Comparison versus Placebo \[Treatment/Placebo\].|Time to first wound/infection (SAF-M1)||1.13|0.70|0.3396
72510542|NCT04937816|144551345|OTHER||Hazard Ratio (HR)|0.7||||0.105|TWO_SIDED|95.0|0.46|1.08|||Regression, Cox|Cox regression of time to first wound infections. Cox regression with terms for study, baseline diabetes status and treatment|Comparison versus Placebo \[Treatment/Placebo\].|Time to first wound/infection (SAF-M2)||1.08|0.46|0.1050
72510543|NCT04937816|144551345|OTHER||Hazard Ratio (HR)|1.0||||0.9919|TWO_SIDED|95.0|0.74|1.35|||Regression, Cox|Cox regression for time to first wound/infection on-treatment.|Comparison vs Placebo \[Treatment/Placebo\]|Time to first wound/infection (Trial NCT01131676, all Empagliflozin (10 mg and 25 mg) vs Placebo)||1.35|0.74|0.9919
72510544|NCT04937816|144551345|OTHER||Hazard Ratio (HR)|0.79||||0.3634|TWO_SIDED|95.0|0.48|1.31|||Regression, Cox|Cox regression for time to first wound/infection on-treatment. Cox regression model with terms for baseline diabetes status and treatment.|Comparison vs Placebo \[Treatment/Placebo\]|Time to first wound/infection (Trial NCT03057951)||1.31|0.48|0.3634
72510545|NCT04937816|144551345|OTHER||Hazard Ratio (HR)|0.52||||0.1177|TWO_SIDED|95.0|0.23|1.18|||Regression, Cox|Cox regression for time to first wound/infection on-treatment. Cox regression model with terms for baseline diabetes status and treatment.|Comparison vs Placebo \[Treatment/Placebo\]|Time to first wound/infection (Trial NCT03057977)||1.18|0.23|0.1177
72510546|NCT04937816|144551345|OTHER||Hazard Ratio (HR)|1.0||||0.9992|TWO_SIDED|95.0|0.84|1.19|||Regression, Cox|Cox regression of time to first nervous system disorder. Cox regression with terms for study, baseline diabetes status and treatment.|Comparison versus Placebo \[Treatment/Placebo\].|Time to first nervous system disorder (SAF-M1)||1.19|0.84|0.9992
72481796|NCT02910739|144490617|OTHER|The pharmacokinetic condition to initiate Part 2 of the study would be met if the point estimate for the AUC0-∞ ratio of geometric means (participants with moderate HI / healthy matched control participants) exceeds 1.5.|Geometric least-squares mean ratio (GMR)|1.04|||||TWO_SIDED|90.0|0.83|1.3|||||GMR = geometric least squares mean (GLSM) for moderate HI participants / GLSM for healthy participants.|Per study protocol, the purpose of this analysis is only to estimate the effect of moderate HI on AUC0-∞; no hypothesis testing was planned for this outcome measure.||1.30|0.83|
72481797|NCT02910739|144490618|OTHER||GMR|1.07|||||TWO_SIDED|90.0|0.77|1.5|||||GMR = GLSM for moderate HI participants / GLSM for healthy participants.|Per study protocol, the purpose of this analysis is only to estimate the effect of moderate HI on Cmax; no hypothesis testing was planned for this outcome measure.||1.50|0.77|
72481798|NCT02910739|144490619|OTHER||GMR|1.04|||||TWO_SIDED|90.0|0.82|1.31|||||GMR = GLSM for moderate HI participants / GLSM for healthy participants.|Per study protocol, the purpose of this analysis is only to estimate the effect of moderate HI on AUC0-last; no hypothesis testing was planned for this outcome measure.||1.31|0.82|
72481799|NCT02910739|144490620|OTHER||GMR|1.01|||||TWO_SIDED|90.0|0.8|1.27|||||GMR = GLSM for moderate HI participants / GLSM for healthy participants.|Per study protocol, the purpose of this analysis is only to estimate the effect of moderate HI on AUC0-24hr; no hypothesis testing was planned for this outcome measure.||1.27|0.80|
72481800|NCT02910739|144490621|OTHER||GMR|1.08|||||TWO_SIDED|90.0|0.9|1.3|||||GMR = GLSM for moderate HI participants / GLSM for healthy participants.|Per study protocol, the purpose of this analysis is only to estimate the effect of moderate HI on C24hr; no hypothesis testing was planned for this outcome measure.||1.30|0.90|
72481801|NCT01598311|144490660|NON_INFERIORITY|Non-inferiority was declared when the lower bound of the 95% CI for the difference in adjusted percentage of cured subjects was \> -10%.|Mean Difference (Final Values)|1.4|||||TWO_SIDED|95.0|-4.9|7.6||||||||7.6|-4.9|
72481802|NCT01598311|144490662|SUPERIORITY|Superiority was declared if the lower bound of the 95% CI of the adjusted difference in sustained response was \> 0.|Mean Difference (Final Values)|4.3|||||TWO_SIDED|95.0|-3.6|12.2||||||||12.2|-3.6|
72481803|NCT03602261|144490665|OTHER|||||||0.5536|||||||Fisher Exact|||||||0.5536
72481804|NCT03081052|144490687|EQUIVALENCE|We estimated sample size based on equivalence test of the incidence rates of a binary outcome (e.g. PGD grade 3 (PGD-3)) of two treatment groups as an illustration. Assuming the incidence rate of PGD-3 under iEPO treatment is 0.30 and acceptable margin of the equivalence is ± 0.19, we will need 200 lung transplant patients to have 80% power to detect an actual difference at α=0.05 between two treatment group under this margin.|Risk Difference (RD)|0.049||||0.019|TWO_SIDED|90.0|-0.064|0.162|||two one sided test p-value|||||0.162|-0.064|0.019
72510547|NCT04937816|144551345|OTHER||Hazard Ratio (HR)|1.09||||0.6274|TWO_SIDED|95.0|0.78|1.52|||Regression, Cox|Cox regression of time to first nervous system disorder. Cox regression model with terms for study, baseline diabetes status and treatment.|Comparison versus Placebo \[Treatment/Placebo\].|Time to first nervous system disorder (SAF-M2)||1.52|0.78|0.6274
72481805|NCT03081052|144490688|NON_INFERIORITY|We estimated sample size based on equivalence test of the incidence rates of a binary outcome of two treatment groups as an illustration. Assuming the incidence rate of moderate or severe RV failure under iEPO treatment is 0.113 and acceptable margin of the equivalence is ± 0.15, we will need 224 heart failure patients to have 80% power to detect an actual difference at α=0.05 between two treatment group under this margin.|Risk Difference (RD)|0.025||||0.012|TWO_SIDED|90.0|-0.066|0.116|||two one-sided test p-value|||||0.116|-0.066|0.012
72481806|NCT03081052|144490689|OTHER||Hodges-Lehmann Location Shift|0.0||||0.747|TWO_SIDED|95.0|-3.0|3.0|||Log Rank|||||3|-3|0.747
72481807|NCT03081052|144490689|OTHER||Hodges-Lehmann Location Shift|0.0||||0.638|TWO_SIDED|95.0|-1.0|1.0|||Log Rank|||||1|-1|0.638
72481808|NCT03081052|144490691|OTHER||mean ratio|1.19||||0.453|TWO_SIDED|95.0|0.76|1.87|||log-linear regression|||||1.87|0.76|0.453
72481809|NCT03081052|144490691|OTHER||mean ratio|0.94||||0.816|TWO_SIDED|95.0|0.57|1.56|||log-linear regression|||||1.56|0.57|0.816
72481810|NCT03081052|144490692|OTHER||mean ratio|1.03||||0.864|TWO_SIDED|95.0|0.75|1.41|||log-linear regression|||||1.41|0.75|0.864
72481811|NCT03081052|144490692|OTHER||mean ratio|0.97||||0.825|TWO_SIDED|95.0|0.73|1.28|||log-linear regression|||||1.28|0.73|0.825
72481812|NCT03081052|144490693|OTHER||Odds Ratio (OR)|1.43||||0.251|TWO_SIDED|95.0|0.78|2.61|||Chi-squared|||||2.61|0.78|0.251
72481813|NCT03081052|144490693|OTHER||Odds Ratio (OR)|1.2||||0.619|TWO_SIDED|95.0|0.58|2.5|||Chi-squared|||||2.5|0.58|0.619
72481814|NCT03081052|144490695|OTHER||Odds Ratio (OR)|2.13||||0.614|TWO_SIDED|95.0|0.19|23.82|||Fisher Exact|||||23.82|0.19|0.614
72481815|NCT03081052|144490695|OTHER||Odds Ratio (OR)|0.6||||0.5424|TWO_SIDED|95.0|0.17|2.12|||Fisher Exact|||||2.12|0.17|0.5424
72481816|NCT00720941|144490710|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority is defined as excluding a difference of greater than 25% in the hazards. The upper limit of the 95% confidence interval must be \<1.25.|Hazard Ratio (HR)|1.0466|||||TWO_SIDED|95.0|0.8982|1.2195|||||The HR is estimated by the Cox regression model using treatment stratification factors as covariates. The HR is adjusted for Karnofsky Performance Scale scores, prior nephrectomy, and Baseline levels of lactate dehydrogenase (\<=1.5xULN, \>1.5xULN).|||1.2195|0.8982|
72481817|NCT00604279|144490729|NON_INFERIORITY_OR_EQUIVALENCE|The predetermined margin for non-inferiority of paliperidone palmitate was 5.5 points|Least Square Mean Difference|-2.3|STANDARD_ERROR_OF_MEAN|1.48||||95.0|-5.2|0.63|||ANCOVA|Analysis of covariance (ANCOVA) model with treatment as a factor, and baseline value as a covariate was used.||||0.63|-5.20|
72481818|NCT00604279|144490730|SUPERIORITY_OR_OTHER||Least Square Mean Difference|0.5|STANDARD_ERROR_OF_MEAN|1.34||||95.0|-2.14|3.12|||ANCOVA|Analysis of covariance (ANCOVA) model with treatment as a factor, and baseline value as a covariate was used.||||3.12|-2.14|
72481819|NCT00604279|144490731|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.11||||95.0|-0.33|0.1|||ANCOVA|Analysis of covariance (ANCOVA) model with treatment as a factor, and baseline value as a covariate was used.||||0.10|-0.33|
72481820|NCT00604279|144490732|SUPERIORITY_OR_OTHER||Least Square Mean Difference|3.4|STANDARD_ERROR_OF_MEAN|2.08||||95.0|-0.67|7.5|||ANCOVA|Analysis of covariance (ANCOVA) model with treatment as a factor, and baseline value as a covariate was used.||Statistical Analysis for Quality of sleep||7.50|-0.67|
72481821|NCT00604279|144490732|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|2.02||||95.0|-5.04|2.9|||ANCOVA|Analysis of covariance (ANCOVA) model with treatment as a factor, and baseline value as a covariate was used.||Statistical Analysis for Daytime drowsiness||2.90|-5.04|
72510548|NCT04937816|144551345|OTHER||Hazard Ratio (HR)|0.97||||0.7597|TWO_SIDED|95.0|0.79|1.19|||Regression, Cox|Cox regression for time to first nervous system disorder on-treatment. Cox regression model with a term for treatment.|Comparison vs Placebo \[Treatment/Placebo\]|Time to first nervous system disorder (Trial NCT01131676, all Empagliflozin (10 mg and 25 mg) vs Placebo)||1.19|0.79|0.7597
72510549|NCT04937816|144551345|OTHER||Hazard Ratio (HR)|1.08||||0.7067|TWO_SIDED|95.0|0.74|1.57|||Regression, Cox|Cox regression for time to first nervous system disorder on-treatment. Cox regression model with terms for baseline diabetes status and treatment.|Comparison vs Placebo \[Treatment/Placebo\]|Time to first nervous system disorder (Trial NCT03057951)||1.57|0.74|0.7067
72510550|NCT04937816|144551345|OTHER||Hazard Ratio (HR)|1.12||||0.7404|TWO_SIDED|95.0|0.56|2.25|||Regression, Cox|Cox regression for time to first nervous system disorder on-treatment. Cox regression model with terms for baseline diabetes status and treatment.|Comparison vs Placebo \[Treatment/Placebo\]|time to first nervous system disorder (Trial NCT03057977)||2.25|0.56|0.7404
72510551|NCT04937816|144551345|OTHER||Hazard Ratio (HR)|1.21||||0.1765|TWO_SIDED|95.0|0.92|1.58|||Regression, Cox|Cox regression of time to first volume depletion AE. Cox regression model with terms for study, baseline diabetes status and treatment.|Comparison versus Placebo \[Treatment/Placebo\].|Time to first volume depletion AE (SAF-M1)||1.58|0.92|0.1765
72481822|NCT00604279|144490733|SUPERIORITY_OR_OTHER||Point estimate of relative risk|0.9||||||95.0|0.81|1.01|||Cochran-Mantel-Haenszel|||||1.01|0.81|
72481823|NCT01072877|144490758|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.49|||=|0.0001|TWO_SIDED|95.0|-3.72|-1.27|||ANCOVA|||||-1.27|-3.72|=0.0001
72481824|NCT01072877|144490758|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.54|||<|0.0001|TWO_SIDED|95.0|-4.8|-2.29|||ANCOVA|||||-2.29|-4.80|<0.0001
72481825|NCT01072877|144490758|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.73|||<|0.0001|TWO_SIDED|95.0|-3.98|-1.48|||ANCOVA|||||-1.48|-3.98|<0.0001
72481826|NCT01072877|144490758|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.65|||<|0.0001|TWO_SIDED|95.0|-4.84|-2.46|||ANCOVA|||||-2.46|-4.84|<0.0001
72481827|NCT01072877|144490759|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.78|||=|0.0001|TWO_SIDED|95.0|-1.17|-0.4|||ANCOVA|||||-0.40|-1.17|=0.0001
72481828|NCT01072877|144490759|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.26|||<|0.0001|TWO_SIDED|95.0|-1.65|-0.86|||ANCOVA|||||-0.86|-1.65|<0.0001
72481829|NCT01072877|144490759|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.45|||<|0.0001|TWO_SIDED|95.0|-1.85|-1.06|||ANCOVA|||||-1.06|-1.85|<0.0001
72481830|NCT01072877|144490759|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.6|||<|0.0001|TWO_SIDED|95.0|-1.98|-1.23|||ANCOVA|||||-1.23|-1.98|<0.0001
72481831|NCT01072877|144490760|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.45|||=|0.0001|TWO_SIDED|95.0|-0.66|-0.23|||ANCOVA|||||-0.23|-0.66|=0.0001
72481832|NCT01072877|144490760|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.76|||<|0.0001|TWO_SIDED|95.0|-0.98|-0.53|||ANCOVA|||||-0.53|-0.98|<0.0001
72481833|NCT01072877|144490760|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.75|||<|0.0001|TWO_SIDED|95.0|-0.97|-0.53|||ANCOVA|||||-0.53|-0.97|<0.0001
72481834|NCT01072877|144490760|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.9|||<|0.0001|TWO_SIDED|95.0|-1.11|-0.68|||ANCOVA|||||-0.68|-1.11|<0.0001
72481835|NCT00719563|144490831|SUPERIORITY_OR_OTHER|||||||0.0737|||||||Wilcoxon Rank Sum|||||||0.0737
72481836|NCT00420017|144490844|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.38||||0.02|TWO_SIDED|95.0|0.16|0.86|||Chi-squared|||||0.86|0.16|0.02
72481837|NCT00420017|144490845|SUPERIORITY_OR_OTHER|||||||0.31||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.31
72481838|NCT00420017|144490846|SUPERIORITY_OR_OTHER|||||||0.097||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.097
72481839|NCT00420017|144490847|SUPERIORITY_OR_OTHER|||||||0.66||95.0|||||Chi-squared|||||||0.66
72481840|NCT00820027|144490861|SUPERIORITY||Difference in Least Squares Mean|-0.49||||0.018|TWO_SIDED|95.0|-0.89|-0.08|||longitudinal data analysis (LDA)|Estimate from LDA model with terms for baseline pain intensity, type of anesthesia, treatment, day, and interaction of day by treatment.||||-0.08|-0.89|0.018
72481841|NCT00820027|144490861|SUPERIORITY||Difference in Least Squares Mean|-0.54||||0.009|TWO_SIDED|95.0|-0.95|-0.14|||LDA|Estimate from LDA model with terms for baseline pain intensity, type of anesthesia, treatment, day, and interaction of day by treatment.||||-0.14|-0.95|0.009
72510552|NCT04937816|144551345|OTHER||Hazard Ratio (HR)|1.22||||0.1978|TWO_SIDED|95.0|0.9|1.66|||Regression, Cox|Cox regression of time to first volume depletion AE. Cox regression with terms for study, baseline diabetes status and treatment.|Comparison versus Placebo \[Treatment/Placebo\].|Time to first volume depletion AE (SAF-M2)||1.66|0.90|0.1978
72510553|NCT04937816|144551345|OTHER||Hazard Ratio (HR)|1.14||||0.6561|TWO_SIDED|95.0|0.64|2.05|||Regression, Cox|Cox regression for time to first volume depletion on-treatment. Cox regression model with a term for treatment.|Comparison vs Placebo \[Treatment/Placebo\]|Time to first volume depletion (Trial NCT01131676, all Empagliflozin (10 mg and 25 mg) vs Placebo)||2.05|0.64|0.6561
72510554|NCT04937816|144551345|OTHER||Hazard Ratio (HR)|1.29||||0.1699|TWO_SIDED|95.0|0.9|1.87|||Regression, Cox|Cox regression for time to first volume depletion on-treatment. Cox regression model with terms for baseline diabetes status and treatment.|Comparison vs Placebo \[Treatment/Placebo\]|Time to first volume depletion (Trial NCT03057951)||1.87|0.90|0.1699
72510555|NCT04937816|144551345|OTHER||Hazard Ratio (HR)|1.08||||0.7944|TWO_SIDED|95.0|0.62|1.87|||Regression, Cox|Cox regression for time to first volume depletion on-treatment. Cox regression model with terms for baseline diabetes status and treatment.|Comparison vs Placebo \[Treatment/Placebo\]|Time to first volume depletion (Trial NCT03057977)||1.87|0.62|0.7944
72481842|NCT00820027|144490862|SUPERIORITY||Between-Treatment Ratio|0.69|||<|0.001|TWO_SIDED|95.0|0.56|0.85|||ANOVA|Estimate from ANOVA model with terms for baseline pain intensity, type of anesthesia, treatment, day, and interaction of day by treatment.|A ratio \<1 indicates a beneficial effect of Etoricoxib.|||0.85|0.56|<0.001
72481843|NCT00820027|144490862|SUPERIORITY||Between-Treatment Ratio|0.66|||<|0.001|TWO_SIDED|95.0|0.54|0.82|||ANOVA|Estimate from ANOVA model with terms for baseline pain intensity, type of anesthesia, treatment, day, and interaction of day by treatment.|A ratio \<1 indicates a beneficial effect of Etoricoxib.|||0.82|0.54|<0.001
72481844|NCT00820027|144490863|OTHER||Difference in Percent|0.5||||0.506|TWO_SIDED|95.0|-3.3|2.5|||Miettinen & Nurminen|||||2.5|-3.3|0.506
72481845|NCT00820027|144490863|OTHER||Difference in Percent|0.0|||>|0.999|TWO_SIDED|95.0|-3.8|1.7|||Miettinen & Nurminen|||||1.7|-3.8|>0.999
72481846|NCT00820027|144490863|OTHER||Difference in Percent|0.0|||>|0.999|TWO_SIDED|95.0|-3.8|1.7|||Miettinen & Nurminen|||||1.7|-3.8|>0.999
72510556|NCT04937816|144551346|OTHER||Hazard Ratio (HR)|1.02||||0.9276|TWO_SIDED|95.0|0.73|1.42|||Regression, Cox|Cox regression model with terms for study, baseline diabetes status and treatment.|Comparison versus placebo \[Treatment/Placebo\].|||1.42|0.73|0.9276
72510557|NCT04937816|144551346|OTHER||Hazard Ratio (HR)|0.85||||0.6205|TWO_SIDED|95.0|0.45|1.6|||Regression, Cox|Cox regression model with terms for study, baseline diabetes status and treatment.|Comparison versus placebo \[Treatment/Placebo\]|||1.60|0.45|0.6205
72481847|NCT00820027|144490863|OTHER||Difference in Percent|0.5||||0.316|TWO_SIDED|95.0|-1.3|2.5|||Miettinen & Nurminen|||||2.5|-1.3|0.316
72481848|NCT00820027|144490863|SUPERIORITY||Difference in Percent|0.0|||>|0.999|TWO_SIDED|95.0|-1.7|1.7|||Miettinen & Nurminen|||||1.7|-1.7|>0.999
72481849|NCT00820027|144490863|OTHER||Difference in Percent|0.0|||>|0.999|TWO_SIDED|95.0|-1.7|3.8|||Miettinen & Nurminen|||Placebo vs. Ibuprofen 1800 mg||3.8|-1.7|>0.999
72481850|NCT00820027|144490863|OTHER||Difference in Percent|-0.5||||0.309|TWO_SIDED|95.0|-2.5|1.2|||Miettinen & Nurminen|||||1.2|-2.5|0.309
72481851|NCT00820027|144490864|OTHER||Difference in Percent|-3.2||||0.054|TWO_SIDED|95.0|-9.2|0.1|||Miettinen & Nurminen|||||0.1|-9.2|0.054
72481852|NCT00820027|144490864|OTHER||Difference in Percent|-2.3||||0.209|TWO_SIDED|95.0|-8.4|1.2|||Miettinen & Nurminen|||||1.2|-8.4|0.209
72481853|NCT00820027|144490864|OTHER||Difference in Percent|-2.3||||0.227|TWO_SIDED|95.0|-8.4|1.3|||Miettinen & Nurminen|||||1.3|-8.4|0.227
72481854|NCT00820027|144490864|OTHER||Difference in Percent|-0.9||||0.415|TWO_SIDED|95.0|-3.7|1.6|||Miettinen & Nurminen|||||1.6|-3.7|0.415
72481855|NCT00820027|144490864|OTHER||Difference in Percent|-0.1||||0.965|TWO_SIDED|95.0|-3.0|2.8|||Miettinen & Nurminen|||||2.8|-3.0|0.965
72481856|NCT00820027|144490864|OTHER||Difference in Percent|2.3||||0.227|TWO_SIDED|95.0|-1.3|8.4|||Miettinen & Nurminen|||Placebo vs. Ibuprofen 1800 mg||8.4|-1.3|0.227
72481857|NCT00820027|144490864|OTHER||Difference in Percent|0.8||||0.437|TWO_SIDED|95.0|-1.7|3.6|||Miettinen & Nurminen|||||3.6|-1.7|0.437
72481858|NCT00820027|144490865|OTHER||Difference in Percent|0.5||||0.806|TWO_SIDED|95.0|-5.3|4.5|||Miettinen & Nurminen|||||4.5|-5.3|0.806
72481859|NCT00820027|144490865|OTHER||Difference in Percent|-1.8||||0.278|TWO_SIDED|95.0|-7.4|1.4|||Miettinen & Nurminen|||||1.4|-7.4|0.278
72481860|NCT00820027|144490865|OTHER||Difference in Percent|0.1||||0.971|TWO_SIDED|95.0|-5.7|3.9|||Miettinen & Nurminen|||||3.9|-5.7|0.971
72481861|NCT00820027|144490865|OTHER||Difference in Percent|0.5||||0.786|TWO_SIDED|95.0|-3.2|4.2|||Miettinen & Nurminen|||||4.2|-3.2|0.786
72481862|NCT00820027|144490865|OTHER||Difference in Percent|-1.8||||0.184|TWO_SIDED|95.0|-5.2|1.0|||Miettinen & Nurminen|||||1.0|-5.2|0.184
72481863|NCT00820027|144490865|OTHER||Difference in Percent|-0.1||||0.971|TWO_SIDED|95.0|-3.9|5.7|||Miettinen & Nurminen|||Placebo vs. Ibuprofen 1800 mg||5.7|-3.9|0.971
72481864|NCT00820027|144490865|OTHER||Difference in Percent|-2.3||||0.113|TWO_SIDED|95.0|-5.8|0.6|||Miettinen & Nurminen|||||0.6|-5.8|0.113
72481865|NCT00820027|144490866|OTHER||Difference in Percent|-5.3||||0.365|TWO_SIDED|95.0|-17.0|6.0|||Miettinen & Nurminen|||||6.0|-17.0|0.365
72481866|NCT00820027|144490866|OTHER||Difference in Percent|-7.2||||0.222||95.0|-18.8|4.2|||Miettinen & Nurminen|||||4.2|-18.8|0.222
72481867|NCT00820027|144490866|OTHER||Difference in Percent|-5.5||||0.349|TWO_SIDED|95.0|-17.2|5.9|||Miettinen & Nurminen|||||5.9|-17.2|0.349
72401991|NCT02515942|144311354|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|0.51||||0.3929|TWO_SIDED|80.0|-1.89|2.91|||Mixed Models Analysis|||Change from baseline at Day 2||2.91|-1.89|0.3929
72481868|NCT00820027|144490866|OTHER||Difference in Percent|0.2||||0.965|TWO_SIDED|95.0|-8.7|9.0|||Miettinen & Nurminen|||||9.0|-8.7|0.965
72481869|NCT00820027|144490866|OTHER||Difference in Percent|-1.6||||0.718|TWO_SIDED|95.0|-10.5|7.3|||Miettinen & Nurminen|||||7.3|-10.5|0.718
72481870|NCT00820027|144490866|OTHER||Difference in Percent|5.5||||0.349|TWO_SIDED|95.0|-5.9|17.2|||Miettinen & Nurminen|||Placebo vs. Ibuprofen 1800 mg||17.2|-5.9|0.349
72481871|NCT00820027|144490866|OTHER||Difference in Percent|1.8||||0.684|TWO_SIDED|95.0|-7.0|10.6|||Miettinen & Nurminen|||||10.6|-7.0|0.684
72481872|NCT00820027|144490867|NON_INFERIORITY|Non-inferiority reached if the upper bound of the 95% confidence interval of the between-treatment difference (Etoricoxib minus Ibuprofen) in LS means is no greater than 1.|Difference in Least Squares Mean|-0.04|||||TWO_SIDED|95.0|-0.36|0.27||||||||0.27|-0.36|
72510558|NCT04937816|144551346|OTHER||Hazard Ratio (HR)|1.09||||0.6768|TWO_SIDED|95.0|0.73|1.63|||Regression, Cox|Cox regression model with terms for treatment.|Comparison vs Placebo \[Treatment/Placebo\]|Empagliflozin (10 mg + 25 mg) versus Placebo.||1.63|0.73|0.6768
72481873|NCT00820027|144490867|NON_INFERIORITY|Non-inferiority reached if the upper bound of the 95% confidence interval of the between-treatment difference (Etoricoxib minus Ibuprofen) in LS means is no greater than 1.|Mean Difference (Final Values)|-0.1|||||TWO_SIDED|95.0|-0.42|0.22||||||||0.22|-0.42|
72481874|NCT00820027|144490868|OTHER|Estimate from ANOVA model with terms for baseline pain intensity, type of anesthesia, treatment, day, and interaction of day by treatment.|Between-Treatment Ratio|1.05|||||TWO_SIDED|95.0|0.89|1.23|||||A ratio \<1 indicates a beneficial effect of Etoricoxib.|||1.23|0.89|
72481875|NCT00820027|144490868|OTHER|Estimate from ANOVA model with terms for baseline pain intensity, type of anesthesia, treatment, day, and interaction of day by treatment.|Between-Treatment Ratio|1.01|||||TWO_SIDED|95.0|0.85|1.18|||||A ratio \<1 indicates a beneficial effect of Etoricoxib.|||1.18|0.85|
72481876|NCT00820027|144490868|OTHER|Estimate from ANOVA model with terms for baseline pain intensity, type of anesthesia, treatment, day, and interaction of day by treatment.|Between-Treatment Ratio|1.04|||||TWO_SIDED|95.0|0.89|1.23|||||A ratio \<1 indicates a beneficial effect of Etoricoxib.|||1.23|0.89|
72481877|NCT02982187|144490870|SUPERIORITY||Odds Ratio (OR)|29.114|||<|0.001|TWO_SIDED|95.0|11.047||The upper bound of the 95% CI could not be calculated due to the low number of events and is therefore displayed as NA.||stratified exact logistic model||Odds ratio, 95% CI and P-value obtained from a stratified exact logistic model. Participant is included in the model as fixed strata, treatment option in the exact statement and period included as a fixed effect.|Sub study 1: DISKUS + HandiHaler vs ELLIPTA|||11.047|<0.001
72481878|NCT02982187|144490870|SUPERIORITY||Odds Ratio (OR)|27.744|||<|0.001|TWO_SIDED|95.0|10.512||The upper bound of the 95% CI could not be calculated due to the low number of events and is therefore displayed as NA.||stratified exact logistic model||Odds ratio, 95% CI and P-value obtained from a stratified exact logistic model. Participant is included in the model as fixed strata, treatment option in the exact statement and period included as a fixed effect.|Sub study 2:Turbuhaler + HandiHaler vs ELLIPTA|||10.512|<0.001
72481879|NCT02982187|144490871|SUPERIORITY||Odds Ratio (OR)|4.248||||0.029|TWO_SIDED|95.0|1.416||The upper bound of the 95% CI could not be calculated due to the low number of events and is therefore displayed as NA.||stratified exact logistic model||Odds ratio, 95% CI and P-value obtained from a stratified exact logistic model. Participant is included in the model as fixed strata, treatment option in the exact statement and period included as a fixed effect.|Sub study 1:DISKUS + HandiHaler vs ELLIPTA|||1.416|0.029
72481880|NCT02982187|144490871|SUPERIORITY||Odds Ratio (OR)|3.855||||0.026|TWO_SIDED|95.0|1.394||The upper bound of the 95% CI could not be calculated due to the low number of events and is therefore displayed as NA.||stratified exact logistic model||Odds ratio, 95% CI and P-value obtained from a stratified exact logistic model. Participant is included in the model as fixed strata, treatment option in the exact statement and period included as a fixed effect.|Sub study 2:Turbuhaler + HandiHaler vs ELLIPTA|||1.394|0.026
72481881|NCT02982187|144490872|SUPERIORITY||Odds Ratio (OR)|2.0||||0.4|TWO_SIDED|95.0|0.459||The upper bound of the 95% CI could not be calculated due to the low number of events and is therefore displayed as NA.||stratified exact logistic model||Odds ratio, 95% CI and P-value obtained from a stratified exact logistic model. Participant is included in the model as fixed strata, treatment option in the exact statement and period included as a fixed effect.|Sub study 1:DISKUS + HandiHaler vs ELLIPTA|||0.459|0.400
72510559|NCT04937816|144551346|OTHER||Hazard Ratio (HR)|0.73||||0.4294|TWO_SIDED|95.0|0.34|1.59|||Regression, Cox|Cox regression model with terms for baseline diabetes status and treatment.|Comparison versus Placebo \[Treatment /Placebo\]|||1.59|0.34|0.4294
72510560|NCT04937816|144551346|OTHER||Hazard Ratio (HR)|1.17||||0.7826|TWO_SIDED|95.0|0.39|3.47|||Regression, Cox|Cox regression model with terms for baseline diabetes status and treatment.|Comparison versus Placebo \[Treatment /Placebo\]|||3.47|0.39|0.7826
72510561|NCT05281523|144551355|OTHER|Analysis performed using a repeated measures model with covariates of treatment group, baseline score, log(e) baseline blood eosinophil count, region, previous surgery for nasal polyps, visit, visit by baseline, and visit by treatment group.|Difference in Least Square Means|-0.6||||0.004|TWO_SIDED|95.0|-1.0|-0.2|||Mixed Models Analysis|||To assess the efficacy of depemokimab 100mg SC + SoC compared to placebo + SoC at Week 52 in participants with a diagnosis of CRSwNP||-0.2|-1.0|0.004
72510562|NCT05281523|144551356|OTHER|Analysis performed using a repeated measures model with covariates of treatment group, baseline score, log(e) baseline blood eosinophil count, region, previous surgery for nasal polyps, visit, subgroup, visit by baseline, visit by treatment group.|Difference in Least Square Means|-0.25||||0.025|TWO_SIDED|95.0|-0.46|-0.03|||Mixed Models Analysis|||To assess the efficacy of depemokimab 100mg SC + SoC compared to placebo + SoC at Week 52 in participants with a diagnosis of CRSwNP||-0.03|-0.46|0.025
72510563|NCT05281523|144551357|OTHER|Analysis performed using a repeated measures model with covariates of treatment group, baseline score, log(e) baseline blood eosinophil count, region, previous surgery for nasal polyps, visit, subgroup, visit by baseline, visit by treatment group, subgroup by treatment group and subgroup by visit by treatment group.|Difference in Least Square Means|-0.18||||0.125|TWO_SIDED|95.0|-0.4|0.05|||Mixed Models Analysis|||To assess the efficacy of depemokimab 100mg SC + SoC compared to placebo + SoC at Week 49 to Week 52 in participants with a diagnosis of CRSwNP||0.05|-0.40|0.125
72566830|NCT02312713|144664442|NON_INFERIORITY|Since there were not sufficient data in prior literature to specific an a priori non-inferiority margin, for this and other secondary outcomes we based conclusions and discussions on magnitude of differences between the group, descriptively. This strategy was specified in the protocol.|Mean Difference (Final Values)|1.57||||0.36|TWO_SIDED|95.0|-1.77|4.92|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Internet Based Exercise Training at 4 months for KOOS Pain.||4.92|-1.77|0.36
72481882|NCT02982187|144490872|SUPERIORITY||Odds Ratio (OR)|1.732||||0.5|TWO_SIDED|95.0|0.397||The upper bound of the 95% CI could not be calculated due to the low number of events and is therefore displayed as NA.||stratified exact logistic model||Odds ratio, 95% CI and P-value obtained from a stratified exact logistic model. Participant is included in the model as fixed strata, treatment option in the exact statement and period included as a fixed effect.|Sub study 2:Turbuhaler + HandiHaler vs ELLIPTA|||0.397|0.500
72481883|NCT02982187|144490873|SUPERIORITY||Odds Ratio (OR)|24.539|||<|0.001|TWO_SIDED|95.0|9.268||The upper bound of the 95% CI could not be calculated due to the low number of events and is therefore displayed as NA.||stratified exact logistic model||Odds ratio, 95% CI and P-value obtained from a stratified exact logistic model. Participant is included in the model as fixed strata, treatment option in the exact statement and period included as a fixed effect.|Sub study 1:DISKUS + HandiHaler vs ELLIPTA|||9.268|<0.001
72481884|NCT02982187|144490873|SUPERIORITY||Odds Ratio (OR)|17.974|||<|0.001|TWO_SIDED|95.0|7.239||The upper bound of the 95% CI could not be calculated due to the low number of events and is therefore displayed as NA.||stratified exact logistic model||Odds ratio, 95% CI and P-value obtained from a stratified exact logistic model. Participant is included in the model as fixed strata, treatment option in the exact statement and period included as a fixed effect.|Sub study 2:Turbuhaler + HandiHaler vs ELLIPTA|||7.239|<0.001
72566831|NCT02312713|144664442|NON_INFERIORITY|Since there were not sufficient data in prior literature to specific an a priori non-inferiority margin, for this and other secondary outcomes we based conclusions and discussions on magnitude of differences between the group, descriptively. This strategy was specified in the protocol.|Mean Difference (Final Values)|2.51||||0.17|TWO_SIDED|95.0|-1.11|6.14|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Internet-Based Exercise Training at 12 months for KOOS Pain.||6.14|-1.11|0.17
72481885|NCT02982187|144490874|SUPERIORITY||Odds Ratio (OR)|3.237||||0.067|TWO_SIDED|95.0|1.124||The upper bound of the 95% CI could not be calculated due to the low number of events and is therefore displayed as NA.||stratified exact logistic model||Odds ratio, 95% CI and P-value obtained from a stratified exact logistic model. Participant is included in the model as fixed strata, treatment option in the exact statement and period included as a fixed effect.|Sub study 1:DISKUS + HandiHaler vs ELLIPTA|||1.124|0.067
72481886|NCT02982187|144490874|SUPERIORITY||Odds Ratio (OR)|6.357||||0.003|TWO_SIDED|95.0|2.219||The upper bound of the 95% CI could not be calculated due to the low number of events and is therefore displayed as NA.||stratified exact logistic model||Odds ratio, 95% CI and P-value obtained from a stratified exact logistic model. Participant is included in the model as fixed strata, treatment option in the exact statement and period included as a fixed effect.|Sub study 2:Turbuhaler + HandiHaler vs ELLIPTA|||2.219|0.003
72481887|NCT02982187|144490875|SUPERIORITY||||||||||||||stratified exact logistic model|||Sub study 1: DISKUS + HandiHaler vs ELLIPTA|These statistics were only presented when the model successfully converged. A stratified exact logistic model was used with participant included in the model as fixed strata, treatment option in the exact statement and period included as a fixed effect.|||
72481888|NCT02982187|144490875|SUPERIORITY||Odds Ratio (OR)|1.732||||0.5|TWO_SIDED|95.0|0.397||The upper bound of the 95% CI could not be calculated due to the low number of events and is therefore displayed as NA.||stratified exact logistic model||Odds ratio, 95% CI and P-value obtained from a stratified exact logistic model. Participant is included in the model as fixed strata, treatment option in the exact statement and period included as a fixed effect.|Sub study 2:Turbuhaler + HandiHaler vs ELLIPTA|||0.397|0.500
72481889|NCT02982187|144490876|SUPERIORITY||||||<|0.001|||||||Wilcoxon signed rank test|This method of analysis does not take sequence of treatment option into account||Sub study 1:DISKUS + HandiHaler vs ELLIPTA||||<0.001
72481890|NCT02982187|144490876|SUPERIORITY||||||<|0.001|||||||Wilcoxon signed rank test|This method of analysis does not take sequence of treatment option into account||Sub study 2:Turbuhaler + HandiHaler vs ELLIPTA||||<0.001
72481891|NCT02982187|144490880|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
72510564|NCT05281523|144551358|OTHER|Analysis performed using a repeated measures model with covariates of treatment group, baseline score, log(e) baseline blood eosinophil count, region, previous surgery for nasal polyps, visit, subgroup, visit by baseline, visit by treatment group, subgroup by treatment group and subgroup by visit by treatment group. If the hierarchy is broken, subsequent endpoints were evaluated for nominal significance in a descriptive manner, using a 5% reference level.|Difference in Least Square Means|-0.26||||0.007|TWO_SIDED|95.0|-0.45|-0.07|||Mixed Models Analysis|||To assess the efficacy of depemokimab 100mg SC + SoC compared to placebo + SoC at Week 49 to Week 52 in participants with a diagnosis of CRSwNP||-0.07|-0.45|0.007
72510565|NCT05281523|144551359|OTHER|Analysis performed using an analysis of covariance model with covariates of treatment group, baseline score, log(e) baseline blood eosinophil count, region and previous surgery for nasal polyps. If the hierarchy is broken, subsequent endpoints were evaluated for nominal significance in a descriptive manner, using a 5% reference level|Difference in Least Square Means|-3.2|||<|0.001|TWO_SIDED|95.0|-4.4|-2.0|||ANCOVA|||To assess the efficacy of depemokimab 100mg SC + SoC compared to placebo + SoC at Week 52 in participants with a diagnosis of CRSwNP||-2.0|-4.4|<0.001
72510566|NCT05281523|144551360|OTHER|Analysis performed using a repeated measures model with covariates of treatment group, baseline score, log(e) baseline blood eosinophil count, region, previous surgery for nasal polyps, visit, visit by baseline, and visit by treatment group. If the hierarchy is broken, subsequent endpoints were evaluated for nominal significance in a descriptive manner, using a 5% reference level.|Difference in Least Square Means|-9.9||||0.015|TWO_SIDED|95.0|-17.9|-2.0|||Mixed Models Analysis|||To assess the efficacy of depemokimab 100mg SC + SoC compared to placebo + SoC at Week 52 in participants with a diagnosis of CRSwNP||-2.0|-17.9|0.015
72510567|NCT05281523|144551361|OTHER|Analysis performed using a repeated measures model with covariates of treatment group, baseline score, log(e) baseline blood eosinophil count, region, previous surgery for nasal polyps, visit, visit by baseline, and visit by treatment group. If the hierarchy is broken, subsequent endpoints were evaluated for nominal significance in a descriptive manner, using a 5% reference level.|Difference in Least Square Means|-0.24||||0.016|TWO_SIDED|95.0|-0.43|-0.04|||Mixed Models Analysis|||To assess the efficacy of depemokimab 100mg SC + SoC compared to placebo + SoC at Week 21 to Week 24 in participants with a diagnosis of CRSwNP||-0.04|-0.43|0.016
72510568|NCT05281523|144551362|OTHER|Analysis performed using a repeated measures model with covariates of treatment group, baseline score, log(e) baseline blood eosinophil count, region, previous surgery for nasal polyps, visit, visit by baseline, and visit by treatment group. If the hierarchy is broken, subsequent endpoints were evaluated for nominal significance in a descriptive manner, using a 5% reference level.|Difference in Least Square Means|-0.3||||0.066|TWO_SIDED|95.0|-0.7|0.0|||Mixed Models Analysis|||To assess the efficacy of depemokimab 100mg SC + SoC compared to placebo + SoC at Week 26 in participants with a diagnosis of CRSwNP||0.0|-0.7|0.066
72510569|NCT05281523|144551363|OTHER|Cox Proportional Hazards Model with covariates of treatment, baseline total endoscopic nasal polyps score, baseline nasal obstruction score (VRS), log(e) baseline blood eosinophil count, region, study and previous surgery for nasal polyps. The covariate for study is removed for the individual-study analyses.|Hazard Ratio (HR)|0.735||||0.128|TWO_SIDED|95.0|0.495|1.092|||Cox Proportional Hazards Model|||To assess the efficacy of depemokimab 100mg SC + SoC compared to placebo + SoC at Week 52 in participants with a diagnosis of CRSwNP (pooled analysis)||1.092|0.495|0.128
72510570|NCT05281523|144551364|OTHER|Cox Proportional Hazards Model with covariates of treatment, baseline total endoscopic nasal polyps score, baseline nasal obstruction score (VRS), log(e) baseline blood eosinophil count, region, study and previous surgery for nasal polyps. The covariate for study is removed for the individual-study analyses. If the hierarchy is broken, subsequent endpoints were evaluated for nominal significance in a descriptive manner, using a 5% reference level.|Hazard Ratio (HR)|0.713||||0.146|TWO_SIDED|95.0|0.453|1.124|||Cox Proportional Hazards Model|||To assess the efficacy of depemokimab 100mg SC + SoC compared to placebo + SoC at Week 52 in participants with a diagnosis of CRSwNP (pooled analysis)||1.124|0.453|0.146
72510571|NCT05281523|144551365|OTHER|Logistic regression with covariates of treatment, number of courses of systemic CS in 12 months prior to screening for NP (0, 1,\>1), log(e) baseline blood eosinophil count, baseline total endoscopic NP score, baseline nasal obstruction score (VRS), region, study and previous surgery for NPs. The study covariate is removed for individual study analyses. If the hierarchy is broken, subsequent endpoints were evaluated for nominal significance in a descriptive manner, using a 5% reference level.|Odds Ratio (OR)|0.58||||0.006|TWO_SIDED|95.0|0.4|0.86|||Regression, Logistic|||To assess the efficacy of depemokimab 100mg SC + SoC compared to placebo + SoC at Week 52 in participants with a diagnosis of CRSwNP (pooled analysis)||0.86|0.40|0.006
72510572|NCT05281523|144551366|OTHER|The pooled statistical analyses was performed using a Mixed Models Repeated Measures (MMRM) model with covariates of treatment group, baseline score, log(e) baseline blood eosinophil count, region, previous surgery for nasal polyps, study, visit and interaction terms for visit by baseline score and visit by treatment group. If the hierarchy is broken, subsequent endpoints were evaluated for nominal significance in a descriptive manner, using a 5% reference level.|Difference in Least Square Means|-0.75||||0.004|TWO_SIDED|95.0|-1.26|-0.25|||Mixed Models Analysis|||To assess the efficacy of depemokimab 100mg SC + SoC compared to placebo + SoC at Week 52 in participants with a diagnosis of CRSwNP (pooled analysis).||-0.25|-1.26|0.004
72510573|NCT05513391|144551367|NON_INFERIORITY|Non inferiority for GMTs was demonstrated if the lower limit of the 2-sided 95% confidence interval (CI) of the GMT ratio was greater than (\>) 0.667 for each virus strain.|GMT Ratio|1.28|||||TWO_SIDED|95.0|0.948|1.73||||||Statistical analysis for A/H1N1||1.73|0.948|
72566832|NCT02312713|144664442|SUPERIORITY||Mean Difference (Final Values)|3.94||||0.06|TWO_SIDED|95.0|-0.19|8.06|||Mixed Models Analysis|||This is the comparison between Internet Based Exercise Training and Wait List Control at 4 months for KOOS Pain.||8.06|-0.19|0.06
72566833|NCT02312713|144664442|SUPERIORITY||Mean Difference (Final Values)|3.36||||0.14|TWO_SIDED|95.0|-1.08|7.79|||Mixed Models Analysis|||This is the comparison between Internet Based Exercise Training and Wait List Control at 12 months for KOOS Pain.||7.79|-1.08|0.14
72566834|NCT02312713|144664442|SUPERIORITY||Mean Difference (Final Values)|2.37||||0.25|TWO_SIDED|95.0|-1.67|6.4|||Mixed Models Analysis|||This is the comparison between Standard Physical Therapy and Wait List Control at 4 months for KOOS Pain.||6.4|-1.67|0.25
72566835|NCT02312713|144664442|SUPERIORITY||Mean Difference (Final Values)|0.85||||0.7|TWO_SIDED|95.0|-3.48|5.18|||Mixed Models Analysis|||This is the comparison between Standard Physical Therapy and Wait List Control at 12 months for KOOS Pain.||5.18|-3.48|0.70
72481892|NCT02982187|144490880|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
72481893|NCT02982187|144490881|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
72481894|NCT02982187|144490881|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
72481895|NCT01630434|144490894|NON_INFERIORITY|The non-inferiority margin, which is here taken to be 0.04.|difference of proportion|-0.091||||0.004|ONE_SIDED|95.0||-0.01|||Wald Method|||||-0.01||0.004
72481896|NCT01630434|144490894|NON_INFERIORITY|The non-inferiority margin, which is here taken to be 0.04.|difference of proportion|-0.038||||0.06|ONE_SIDED|95.0||0.045|||Wald Method|||||0.045||0.06
72481897|NCT01630434|144490895|NON_INFERIORITY|The non-inferiority margin is 5%.|Difference of proportions|-0.015||||0.0003|ONE_SIDED|95.0||0.016|||Wald Method|||||0.016||0.0003
72481898|NCT01630434|144490895|NON_INFERIORITY|The non-inferiority margin is 5%.|Difference of proportions|0.006||||0.027|ONE_SIDED|95.0||0.044|||Wald Method|||||0.044||0.027
72481899|NCT01630434|144490896|NON_INFERIORITY|The non-inferiority margin is 7.5%.|Difference of proportions|0.035||||0.118|ONE_SIDED|95.0||0.091|||Wald Method|||||0.091||0.118
72481900|NCT01630434|144490896|NON_INFERIORITY|The non-inferiority margin is 7.5%.|Difference of proportions|0.065||||0.389|ONE_SIDED|95.0||0.124|||Wald Method|||||0.124||0.389
72481901|NCT01630434|144490897|NON_INFERIORITY|The non-inferiority margin is 4%|Difference of proportions|0.043|||||ONE_SIDED|95.0||0.071||||||||0.071||
72510574|NCT05513391|144551367|NON_INFERIORITY|Non inferiority for GMTs was demonstrated if the lower limit of the 2-sided 95% CI of the GMT ratio was \> 0.667 for each virus strain.|GMT Ratio|2.53|||||TWO_SIDED|95.0|1.93|3.3||||||Statistical analysis for A/H3N2||3.30|1.93|
72510575|NCT05513391|144551367|NON_INFERIORITY|Non inferiority for GMTs was demonstrated if the lower limit of the 2-sided 95% CI of the GMT ratio was \> 0.667 for each virus strain.|GMT Ratio|0.515|||||TWO_SIDED|95.0|0.397|0.668||||||Statistical analysis for B/Victoria||0.668|0.397|
72623995|NCT02231580|144778420|SUPERIORITY_OR_OTHER||GLS mean ratio|1.242|||=|0.0152|TWO_SIDED|90.0|1.077|1.433|||MMRM|||Left finger IPI duration statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||1.433|1.077|=0.0152
72623996|NCT02231580|144778420|SUPERIORITY_OR_OTHER||GLS mean ratio|1.042|||=|0.6033|TWO_SIDED|90.0|0.915|1.186|||MMRM|||Right finger IPI duration statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||1.186|0.915|=0.6033
72510576|NCT05513391|144551367|NON_INFERIORITY|Non inferiority for GMTs was demonstrated if the lower limit of the 2-sided 95% CI of the GMT ratio was \> 0.667 for each virus strain.|GMT Ratio|1.02|||||TWO_SIDED|95.0|0.799|1.3||||||Statistical analysis for B/Yamagata||1.30|0.799|
72510577|NCT05513391|144551368|NON_INFERIORITY|Non-inferiority for SC was demonstrated if the lower limit of the 2-sided 95% CI was \> -10% for the 4 strains.|Difference in percentage of participants|7.1|||||TWO_SIDED|95.0|-1.55|15.7||||||Statistical analysis for A/H1N1||15.7|-1.55|
72510578|NCT05513391|144551368|NON_INFERIORITY|Non-inferiority for SC was demonstrated if the lower limit of the 2-sided 95% CI was \> -10% for the 4 strains.|Difference in percentage of participants|15.4|||||TWO_SIDED|95.0|5.8|24.7||||||Statistical analysis for A/H3N2||24.7|5.80|
72510579|NCT05513391|144551368|NON_INFERIORITY|Non-inferiority for SC was demonstrated if the lower limit of the 2-sided 95% CI was \> -10% for the 4 strains.|Difference in percentage of participants|-6.91|||||TWO_SIDED|95.0|-14.02|0.1||||||Statistical analysis for B/Victoria||0.10|-14.02|
72510580|NCT05513391|144551368|NON_INFERIORITY|Non-inferiority for SC was demonstrated if the lower limit of the 2-sided 95% CI was \> -10% for the 4 strains.|Difference in percentage of participants|5.81|||||TWO_SIDED|95.0|-1.99|13.6||||||Statistical analysis for B/Yamagata||13.6|-1.99|
72481902|NCT01630434|144490897|NON_INFERIORITY|The non-inferiority margin is 4%.|Difference of proportions|0.054|||||ONE_SIDED|95.0||0.087||||||||0.087||
72481903|NCT01630434|144490898|NON_INFERIORITY|The non-inferiority margin is 0.7.|Mean Difference (Final Values)|-0.045|||<|0.0001|ONE_SIDED|95.0||0.047|||t-test, 2 sided|||||0.047||<0.0001
72481904|NCT01326533|144490981|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||ANCOVA|Adjusted for baseline value as covariate||||||<0.01
72481905|NCT01326533|144490982|SUPERIORITY_OR_OTHER|||||||0.013|TWO_SIDED||||||ANCOVA|Adjusted for baseline value as covariate||||||0.013
72481906|NCT00926211|144490985|NON_INFERIORITY_OR_EQUIVALENCE|Initial planned sample size of 26 would provide approximately 90% power if the survival rate in the implanted transected follicles is at least 40%. Sample size used was 36 with 35 participants completing the 9 month study.|Mean Difference (Net)|-1.4|STANDARD_DEVIATION|15.5||0.023|ONE_SIDED|97.5||3.9||t-test comparison to the upper limit of the non-inferiority margin|t-test, 1 sided|Paired t-test compared to the non-inferiority margin of 4 follicles.|The number of implanted hairs surviving that were harvested using the computer assisted method was subtracted from the number of implanted hairs surviving that were harvested manually.|The hypothesis to be tested is one of non-inferiority. Tests of non-inferiority are one-sided tests and the significance level will be 0.025.||3.9||0.023
72481907|NCT00926211|144490986|NON_INFERIORITY_OR_EQUIVALENCE|Study was powered for the primary efficacy outcome.|Mean Difference (Final Values)|0.045|STANDARD_DEVIATION|0.146|<|0.001|ONE_SIDED|97.5|-0.004||||t-test, 1 sided|Paired t-test.||Paired data with each subject as their own control (treatment was randomly assigned to the left or right side of the scalp). Paired difference was analyzed.|||-.004|<0.001
72481908|NCT04668586|144490987|SUPERIORITY||||||<|0.006|||||||Chi-squared|||||||<0.006
72481909|NCT04668586|144490988|SUPERIORITY|||||||0.008|||||||t-test, 2 sided|Adjusted for four-category stratification group.||||||0.008
72481910|NCT04668586|144490990|SUPERIORITY|||||||1|||||||Chi-squared|||||||1
72481911|NCT04668586|144490991|SUPERIORITY|||||||0.09|||||||Chi-squared, Corrected|Adjusted for four-category stratification group.||||||0.09
72481912|NCT03552822|144490996|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||< 0.001
72510581|NCT05299983|144551424|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<.001
72510582|NCT05299983|144551425|SUPERIORITY|||||||0.02|||||||Chi-squared|||||||0.02
72510583|NCT05299983|144551426|SUPERIORITY|||||||0.22|||||||Chi-squared|||||||0.22
72510584|NCT05299983|144551427|SUPERIORITY|||||||0.45|||||||Chi-squared|||||||0.45
72401992|NCT02515942|144311354|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|3.23||||0.0418|TWO_SIDED|80.0|0.85|5.61|||Mixed Models Analysis|||Change from baseline at Day 2||5.61|0.85|0.0418
72481913|NCT03552822|144490997|SUPERIORITY|||||||0.037|||||||Wilcoxon (Mann-Whitney)|||||||0.037
72481914|NCT03552822|144490998|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||< 0.001
72481915|NCT03552822|144490999|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||< 0.001
72481916|NCT03552822|144491000|SUPERIORITY|||||||0.108|||||||Wilcoxon (Mann-Whitney)|||||||0.108
72481917|NCT03552822|144491001|SUPERIORITY|||||||0.159|||||||Fisher Exact|||||||0.159
72481918|NCT03552822|144491002|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||< 0.001
72481919|NCT03552822|144491003|SUPERIORITY|||||||0.02|||||||Wilcoxon (Mann-Whitney)|||||||0.020
72481920|NCT03552822|144491004|SUPERIORITY|||||||0.085|||||||Wilcoxon (Mann-Whitney)|||||||0.085
72481921|NCT03291587|144491063|SUPERIORITY|With 418 analyzable participants across 13 clinics per group, we have 80% power to detect a group difference in primary outcome (7-day abstinence). This assumes control abstinence rate will be 10% versus 20% intervention rate using a 2-sided Z-test for proportions with alpha=0.05 (2-sided). To account for the clustering we used an intra-class correlation value of 0.03. We plan to enroll 1114-1300 patients (or approximately 42-50 per site) to conservatively allow for 25%- 35.5% loss to follow-up.|Odds Ratio (OR)|0.967||||0.865|TWO_SIDED|96.0|0.652|1.433|||Mixed Models Analysis|||A generalized estimating equation marginal model was used in an intent-to-treat analysis to predict the 7-day tobacco use binary outcome. A binomial distribution with logit link was specified with group, time, and the interaction of group by time included as covariates while allowing intercept and time to vary by participants within site with an exchangeable working correlation matrix designation.||1.433|0.652|0.865
72481922|NCT02197767|144491072|SUPERIORITY|||||||0.072|||||||t-test, 2 sided|||||||0.072
72481923|NCT02197767|144491073|SUPERIORITY|||||||0.068|||||||t-test, 2 sided|||||||0.068
72481924|NCT00381303|144491081|NON_INFERIORITY_OR_EQUIVALENCE|Test for non-inferiority (Delta=15%)|Mean Difference (Final Values)|-9.6|STANDARD_ERROR_OF_MEAN|0.052||0.3|TWO_SIDED|95.0|-19.85|0.68||P-Value for difference (Female - Male): Test for non-inferiority (Delta=15%)|Regression, Logistic|Estimates from logistic regression analysis include baseline log10 viral load and baseline CD4 cell count as covariates and gender as a factor.||"Confidence interval of the difference in proportion of response between two sexes estimated by:~* Application of delta method to be obtained Standard Error (SE)~* Calculation of lower and upper bound using normal approximation to the difference in response rates"||0.68|-19.85|0.30
72481925|NCT03933774|144491091|SUPERIORITY|||||||0.002||||||P value \< 0.05 was considered significant.|t-test, 2 sided|||Null hypothesis: The degree of hyperpigmentation is the same between the tretinoin applied side and placebo applied side.||||0.002
72481926|NCT03933774|144491092|SUPERIORITY|||||||0.479||||||P value \< 0.05 was considered significant.|McNemar|||Null hypothesis: The number of participants who showed ≥75% repigmentation is the same between the tretinoin applied side and placebo applied side.||||0.479
72481927|NCT01966471|144491093|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.827||95.0|0.71|1.32|||Log Rank|||||1.32|0.71|0.8270
72481928|NCT01966471|144491094|SUPERIORITY||Hazard Ratio (HR)|1.01||||0.9291||95.0|0.77|1.34|||Log Rank|||||1.34|0.77|0.9291
72481929|NCT01966471|144491095|SUPERIORITY||Hazard Ratio (HR)|0.98||||0.8756||95.0|0.74|1.3|||Log Rank|||||1.30|0.74|0.8756
72481930|NCT01966471|144491096|SUPERIORITY||Hazard Ratio (HR)|0.99||||0.9341||95.0|0.75|1.31|||Log Rank|||||1.31|0.75|0.9341
72481931|NCT01966471|144491097|SUPERIORITY||Hazard Ratio (HR)|0.88||||0.4577||95.0|0.61|1.25|||Log Rank|||||1.25|0.61|0.4577
72481932|NCT01966471|144491098|SUPERIORITY||Hazard Ratio (HR)|1.24||||0.2864||95.0|0.83|1.84|||Log Rank|||||1.84|0.83|0.2864
72481933|NCT00954421|144491142|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-17.6|STANDARD_DEVIATION|19.4||0.026|TWO_SIDED|95.0|-30.61|-4.65|||two-sided sign-rank test||p-value assessed via sign-rank test (pre-planned method)|The null hypothesis is that the mean change in Tremor Rating Scale score from baseline to six months post-implant (with VIM and VO stimulators turned ON) will be zero||-4.65|-30.61|.026
72481934|NCT00954421|144491143|SUPERIORITY_OR_OTHER||Mean Difference (Net)|8.4|STANDARD_DEVIATION|9.1||0.011|TWO_SIDED|95.0|2.2|14.5||Sign rank test was pre-planned for P-value|Sign-Rank test||p-value assessed using sign rank test|The null hypothesis is that difference in change in Tremor Rating Scale (TRS) score from baseline to 6 months when both stimulators are on (VIM and VO), versus when both stimulators are off, will be zero (i.e., that there will be no difference in effect between having both stimulators on versus both stimulators off)||14.5|2.2|0.011
72481935|NCT00954421|144491143|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.73|STANDARD_DEVIATION|8.49||0.68||95.0|-4.96|6.42|||two-sided sign rank test|two sided sign rank test as pre-planned||The null hypothesis is that difference in change in Tremor Rating Scale (TRS) score from baseline to 6 months when VO is on and VIM is off, versus when VIM is on and VO is off, will be zero (i.e., that there will be no difference in effect between having exclusively VIM versus VO on)||6.42|-4.96|.68
72481936|NCT00567268|144491167|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.004|||||||Fisher Exact|||"The risk factor tested was age. The null hypothesis was that there was no association between the age and the number of responders to the treatment with gabapentin."||||=0.004
72481937|NCT00567268|144491168|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.003|||||||Fisher Exact|||"The risk factor tested was number of concomitant antiepileptic drugs at baseline. The null hypothesis was that there was no linear trend in the number of responders to the treatment with gabapentin across increasing levels of the number of concomitant antiepileptic drugs at baseline."||||=0.003
72481938|NCT00567268|144491168|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.003|||||||Cochran-Armitage|||"The risk factor tested was number of concomitant antiepileptic drugs at baseline. The null hypothesis was that there was no linear trend in the number of responders to the treatment with gabapentin across increasing levels of the number of concomitant antiepileptic drugs at baseline."||||=0.003
72481939|NCT00567268|144491169|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Chi-squared|||"The factor tested was age. The null hypothesis was that there was no difference between \<65 years and \>=65 years in the number of participants who responded to the treatment with gabapentin."||||<0.001
72566836|NCT02312713|144664442|NON_INFERIORITY|Since there were not sufficient data in prior literature to specific an a priori non-inferiority margin, for this and other secondary outcomes we based conclusions and discussions on magnitude of differences between the group, descriptively. This strategy was specified in the protocol.|Mean Difference (Final Values)|-1.32||||0.4|TWO_SIDED|95.0|-4.43|1.79|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Internet Based Exercise Training at 4 months for KOOS ADL.||1.79|-4.43|0.40
72566837|NCT02312713|144664442|NON_INFERIORITY|Since there were not sufficient data in prior literature to specific an a priori non-inferiority margin, for this and other secondary outcomes we based conclusions and discussions on magnitude of differences between the group, descriptively. This strategy was specified in the protocol.|Mean Difference (Final Values)|0.33||||0.84|TWO_SIDED|95.0|-2.93|3.59|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Internet Based Exercise Training at 12 months for KOOS ADL.||3.59|-2.93|0.84
72566838|NCT02312713|144664442|SUPERIORITY||Mean Difference (Final Values)|2.11||||0.28|TWO_SIDED|95.0|-1.73|5.94|||Mixed Models Analysis|||This is the comparison between Internet Based Exercise Training and Wait List Control at 4 month for KOOS ADL.||5.94|-1.73|0.28
72566839|NCT02312713|144664442|SUPERIORITY||Mean Difference (Final Values)|2.79||||0.17|TWO_SIDED|95.0|-1.2|6.77|||Mixed Models Analysis|||This is the comparison between Internet Based Exercise Training and Wait List Control at 12 month for KOOS ADL.||6.77|-1.2|0.17
72566840|NCT02312713|144664442|SUPERIORITY||Mean Difference (Final Values)|3.43||||0.07|TWO_SIDED|95.0|-0.32|7.18|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Wait List Control at 4 months for KOOS ADL.||7.18|-0.32|0.07
72566841|NCT02312713|144664442|SUPERIORITY||Mean Difference (Final Values)|2.45||||0.22|TWO_SIDED|95.0|-1.44|6.34|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Wait List Control at 12 months for KOOS ADL.||6.34|-1.44|0.22
72566842|NCT02312713|144664442|NON_INFERIORITY|Since there were not sufficient data in prior literature to specific an a priori non-inferiority margin, for this and other secondary outcomes we based conclusions and discussions on magnitude of differences between the group, descriptively. This strategy was specified in the protocol.|Mean Difference (Final Values)|-0.21||||0.92|TWO_SIDED|95.0|-4.47|4.06|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Internet Based Exercise Training at 4 months for KOOS Sport/Rec.||4.06|-4.47|.92
72566843|NCT02312713|144664442|NON_INFERIORITY|Since there were not sufficient data in prior literature to specific an a priori non-inferiority margin, for this and other secondary outcomes we based conclusions and discussions on magnitude of differences between the group, descriptively. This strategy was specified in the protocol.|Mean Difference (Final Values)|0.55||||0.82|TWO_SIDED|95.0|-4.15|5.24|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Internet Based Exercise Training at 12 months for KOOS Sport/Rec.||5.24|-4.15|.82
72401993|NCT02515942|144311354|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-0.32||||0.5632|TWO_SIDED|80.0|-2.91|2.27|||Mixed Models Analysis|||Change from baseline at Day 8||2.27|-2.91|0.5632
72401994|NCT02515942|144311354|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|1.29||||0.2575|TWO_SIDED|80.0|-1.25|3.83|||Mixed Models Analysis|||Change from baseline at Day 8||3.83|-1.25|0.2575
72566844|NCT02312713|144664442|SUPERIORITY||Mean Difference (Final Values)|3.71||||0.17|TWO_SIDED|95.0|-1.59|9.0|||Mixed Models Analysis|||This is the comparison between Internet Based Exercise Training and Wait List Control at 4 months for KOOS Sport/Rec.||9|-1.59|0.17
72566845|NCT02312713|144664442|SUPERIORITY||Mean Difference (Final Values)|6.01||||0.04|TWO_SIDED|95.0|0.29|11.74|||Mixed Models Analysis|||This is the comparison between Internet Based Exercise Training and Wait List Control at 12 months for KOOS Sport/Rec.||11.74|0.29|0.04
72623997|NCT02231580|144778421|SUPERIORITY_OR_OTHER||GLS mean ratio|1.657|||=|0.052|TWO_SIDED|90.0|1.086|2.529|||MMRM|||Left finger ITI variability statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||2.529|1.086|=0.0520
72401995|NCT02515942|144311354|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|1.61||||0.2058|TWO_SIDED|80.0|-0.91|4.12|||Mixed Models Analysis|||Change from baseline at Day 8||4.12|-0.91|0.2058
72481940|NCT00567268|144491170|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Chi-squared|||"The factor tested was age. The null hypothesis was that there was no association between the age and the number of participants who responded to the treatment with gabapentin."||||<0.001
72566846|NCT02312713|144664442|SUPERIORITY||Mean Difference (Final Values)|3.91||||0.14|TWO_SIDED|95.0|-1.28|9.1|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Wait List Control at 4 months for KOOS Sport/Rec.||9.1|-1.28|0.14
72566847|NCT02312713|144664442|SUPERIORITY||Mean Difference (Final Values)|5.47||||0.05|TWO_SIDED|95.0|-0.1|11.03|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Wait List Control at 12 months for KOOS Sport/Rec.||11.03|-0.1|0.05
72623998|NCT02231580|144778421|SUPERIORITY_OR_OTHER||GLS mean ratio|0.916|||=|0.6978|TWO_SIDED|90.0|0.63|1.333|||MMRM|||Right finger ITI variability statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||1.333|0.630|=0.6978
72401996|NCT02515942|144311354|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-1.94||||0.8392|TWO_SIDED|80.0|-4.44|0.57|||Mixed Models Analysis|||Change from baseline at Day 15||0.57|-4.44|0.8392
72481941|NCT00567268|144491170|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Cochran-Armitage|||"The factor tested was age. The null hypothesis was that there was no linear trend in the number of responders to the treatment with gabapentin across increasing levels of age categories."||||<0.001
72481942|NCT00567268|144491171|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.008|||||||Chi-squared|||"The factor tested was severity of partial epileptic seizure . The null hypothesis was that there was no association between the degree of severity of partial epileptic seizure (mild, moderate, and severe) and the number of participants who responded to the treatment with gabapentin."||||=0.008
72481943|NCT00567268|144491171|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.002|||||||Cochran-Armitage|||"The factor tested was severity of partial epileptic seizure. The null hypothesis was that there was no linear trend in the number of responders to the treatment with gabapentin across the degree of severity of partial epileptic seizure (mild, moderate, and severe)."||||=0.002
72481944|NCT00567268|144491172|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.018|||||||Chi-squared|||"The factor tested was baseline frequency of epileptic seizure. The null hypothesis was that there was no difference between the baseline frequency of epileptic seizure and the number of participants who responded to the treatment with gabapentin."||||=0.018
72481945|NCT00567268|144491173|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Chi-squared|||"The factor tested was number of concomitant antiepileptic drugs at baseline. The null hypothesis was that there was no association between the number of concomitant antiepileptic drugs at baseline and the number of participants who responded to the treatment with gabapentin."||||<0.001
72481946|NCT00567268|144491173|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Cochran-Armitage|||"The factor tested was number of concomitant antiepileptic drugs at baseline. The null hypothesis was that there was no linear trend in the number of responders to the treatment with gabapentin across increasing levels of the number of concomitant antiepileptic drugs at baseline."||||<0.001
72481947|NCT00567268|144491174|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.025|||||||Cochran-Armitage|||"The factor tested was baseline creatinine clearance. The null hypothesis was that there was no linear trend in the number of responders to the treatment with gabapentin across increasing levels of the baseline creatinine clearance."||||=0.025
72481948|NCT00567268|144491175|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.043|||||||Chi-squared|||"The factor tested was non-drug therapy. The null hypothesis was that there was no difference between the non-drug therapy and the number of participants who responded to the treatment with gabapentin."||||=0.043
72481949|NCT02952001|144491203|SUPERIORITY|||||||0.562||||||The a priori threshold for statistical significance was 0.050. No adjustments made or required for multiplicity.|Log-rank chi-square test|||The null hypothesis of no difference in the survival time distributions was tested.||||0.562
72481950|NCT04533451|144491210|SUPERIORITY|||||||0.0385|||||||Log Rank|||||||0.0385
72481951|NCT04533451|144491212|EQUIVALENCE|Relatively large sample size and groups are independent.||||||0.9829|||||||Chi-squared|||||||0.9829
72481952|NCT03548987|144491219|SUPERIORITY||Treatment difference|-14.75|||<|0.0001|TWO_SIDED|95.0|-16.0|-13.5|||ANCOVA|||Treatment policy estimand||-13.50|-16.00|<0.0001
72481953|NCT03548987|144491219|OTHER||Treatment difference|-15.33|||<|0.0001|TWO_SIDED|95.0|-16.52|-14.13|||MMRM (mixed model repeated measurement)|||Hypothetical estimand||-14.13|-16.52|<0.0001
72481954|NCT02604433|144491272|SUPERIORITY||Odds Ratio (OR)|5.62|||<|0.0001|TWO_SIDED|95.0|2.17|14.53||Significance level of 0.050 for 2-sided tests.|Cochran-Mantel-Haenszel|||Odds ratio 95% confidence intervals (CIs), and p-value were estimated from the Cochran Mantel-Haenszel (CMH) test stratified by the geographical regions defined at randomization.||14.53|2.17|<0.0001
72481955|NCT02604433|144491272|SUPERIORITY||Difference in Percentages|16.5|||||TWO_SIDED|95.0|10.0|23.1|||||Luspatercept - Placebo|||23.1|10.0|
72566848|NCT02312713|144664442|NON_INFERIORITY|Since there were not sufficient data in prior literature to specific an a priori non-inferiority margin, for this and other secondary outcomes we based conclusions and discussions on magnitude of differences between the group, descriptively. This strategy was specified in the protocol.|Mean Difference (Final Values)|0.33||||0.86|TWO_SIDED|95.0|-3.29|3.96|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Internet Based Exercise Training at 4 months for KOOS QOL.||3.96|-3.29|.86
72566849|NCT02312713|144664442|NON_INFERIORITY|Since there were not sufficient data in prior literature to specific an a priori non-inferiority margin, for this and other secondary outcomes we based conclusions and discussions on magnitude of differences between the group, descriptively. This strategy was specified in the protocol.|Mean Difference (Final Values)|2.59||||0.15|TWO_SIDED|95.0|-0.96|6.13|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Internet Based Exercise Training at 12 months for KOOS QOL.||6.13|-0.96|0.15
72481956|NCT02604433|144491272|SUPERIORITY||Common Risk Difference|16.5||||||95.0|9.9|23.1|||||Luspatercept - Placebo|||23.1|9.9|
72481957|NCT02604433|144491273|SUPERIORITY||Odds Ratio (OR)|6.44|||<|0.0001|TWO_SIDED|95.0|2.27|18.26||Significance level of 0.050 for 2-sided tests.|Cochran-Mantel-Haenszel|||Odds ratio 95% CIs, and p-value were estimated from the CMH test stratified by the geographical regions defined at randomization. To control the overall Type 1 error rate for outcomes 2-4, the testing procedure was implemented strictly in order: the test for this outcome was only conducted when there was evidence showing that erythroid response was achieved in the luspatercept group from Week 13 to Week 24 (primary endpoint).||18.26|2.27|<0.0001
72481958|NCT02604433|144491274|SUPERIORITY||Odds Ratio (OR)|4.24||||0.0402|TWO_SIDED|95.0|0.96|18.79||Significance level of 0.050 for 2-sided tests.|Cochran-Mantel-Haenszel|||Odds ratio, 95% CIs, and p-value were estimated from the Cochran-Mantel-Haenszel (CMH) test stratified by the geographical regions defined at randomization. To control the overall Type 1 error rate, the testing procedure was done strictly in order: the test for this outcome was only conducted when there was evidence showing erythroid response was achieved in the luspatercept group for the primary endpoint, and 33% hematological improvement was achieved in the luspatercept group in outcome 2.||18.79|0.96|0.0402
72566850|NCT02312713|144664442|SUPERIORITY||Mean Difference (Final Values)|3.63||||0.11|TWO_SIDED|95.0|-0.85|8.11|||Mixed Models Analysis|||This is the comparison between Internet Based Exercise Training and Wait List Control at 4 months for KOOS QOL.||8.11|-0.85|0.11
72481959|NCT02604433|144491275|SUPERIORITY||Odds Ratio (OR)|11.92||||0.0017|TWO_SIDED|95.0|1.65|86.29||Significance level of 0.050 for 2-sided tests.|Cochran-Mantel-Haenszel|||Odds ratio, 95% CIs, and p-value were estimated from the Cochran-Mantel-Haenszel (CMH) test stratified by the geographical regions defined at randomization. To control the overall Type 1 error rate, the testing procedure was done strictly in order: the test for this outcome was only conducted when there was evidence showing erythroid response was achieved in the luspatercept group for the primary endpoint, and achievement of objective in the luspatercept group in outcomes 2+3.||86.29|1.65|0.0017
72481960|NCT02604433|144491276|SUPERIORITY||LSM Difference|-1.34|||<|0.0001|TWO_SIDED|95.0|-1.76|-0.93||Significance level of 0.050 for 2-sided tests.|ANCOVA|Estimates were based on an ANCOVA model with geographical regions defined at randomization and baseline transfusion burden as covariates.|luspatercept - placebo|Change from baseline at Week 48 LSM = least squares mean||-0.93|-1.76|<0.0001
72481961|NCT02604433|144491277|SUPERIORITY||LS Mean of Difference|0.2||||0.7598|TWO_SIDED|95.0|-1.1|1.51||Significance level of 0.050 for 2-sided tests.|ANCOVA||luspatercept - placebo|Change from baseline at Week 48 P-value ANCOVA model with geographical regions defined at randomization and baseline LIC as covariates. LS = least square||1.51|-1.10|0.7598
72481962|NCT02604433|144491278|SUPERIORITY||LS Mean of Difference|-68.0||||0.2552|TWO_SIDED|95.0|-185.8|49.7||Significance level of 0.050 for 2-sided tests|ANCOVA|Estimates are based on an ANCOVA model with geographical regions defined at randomization and baseline ICT as covariates.|luspatercept - placebo|Deferasirox: Change from baseline at Week 48 LS = least squares||49.7|-185.8|0.2552
72481963|NCT02604433|144491278|SUPERIORITY||LS Mean of Difference|-76.4||||0.7746|TWO_SIDED|95.0|-612.9|460.1||Significance level of 0.050 for 2-sided tests|ANCOVA|Estimates are based on an ANCOVA model with geographical regions defined at randomization and baseline ICT as covariates.|luspatercept - placebo|Deferiprone: Change from baseline at Week 48 LS = least squares||460.1|-612.9|0.7746
72481964|NCT02604433|144491278|SUPERIORITY||LS Mean of Difference|-147.3||||0.5186|TWO_SIDED|95.0|-673.1|378.5||Significance level of 0.050 for 2-sided tests|ANCOVA|Estimates are based on an ANCOVA model with geographical regions defined at randomization and baseline ICT as covariates.|luspatercept - placebo|Deferoxamine Mesilate / Deferoxamine: Change from baseline at Week 48 LS = least squares||378.5|-673.1|0.5186
72481965|NCT02604433|144491279|SUPERIORITY||LS Mean of Difference|-342.59|||<|0.0001|TWO_SIDED|95.0|-498.3|-186.87||Significance level of 0.050 for 2-sided tests|ANCOVA|Estimates based on an ANCOVA model with geographical regions defined at randomization and baseline serum ferritin as covariates.|luspatercept - placebo|Change from baseline at Week 48 LS = least squares||-186.87|-498.30|<0.0001
72481966|NCT02604433|144491280|SUPERIORITY||LS Mean of Difference|0.0||||0.9201|TWO_SIDED|95.0|-0.01|0.01||Significance level of 0.050 for 2-sided tests.|ANCOVA|Estimates are based on an ANCOVA model with geographical regions defined at randomization and baseline BMD measurement as covariates.|luspatercept - placebo|Total Hip Bone Mineral Density: Change from baseline at Week 48 LS = least squares||0.01|-0.01|0.9201
72481967|NCT02604433|144491280|SUPERIORITY||LS Mean of Difference|-0.01||||0.462|TWO_SIDED|95.0|-0.02|0.01||Significance level of 0.050 for 2-sided tests.|ANCOVA|Estimates are based on an ANCOVA model with geographical regions defined at randomization and baseline BMD measurement as covariates.|luspatercept - placebo|Lumbar Spine Bone Mineral Density: Change from baseline at Week 48 LS = least squares||0.01|-0.02|0.4620
72481968|NCT02604433|144491281|SUPERIORITY||LS Mean of Difference|-2.22||||0.0543|TWO_SIDED|95.0|-4.48|0.04||Significance level of 0.050 for 2-sided tests.|ANCOVA|Estimates were based on an ANCOVA model with geographical regions defined at randomization and baseline myocardial T2\* as covariates.|luspatercept - placebo|Change from baseline at Week 48 LS = least square||0.04|-4.48|0.0543
72481969|NCT02604433|144491282|SUPERIORITY|||||||0.666||||||Significance level of 0.050 for 2-sided tests.|t-test, 2 sided|||Physical Health Domain Score - Change from Baseline at Week 24||||0.666
72481970|NCT02604433|144491282|SUPERIORITY|||||||0.384||||||Significance level of 0.050 for 2-sided tests.|t-test, 2 sided|||Total Score - Change from Baseline at Week 24||||0.384
72481971|NCT02604433|144491283|SUPERIORITY|||||||0.918||||||Significance level of 0.050 for 2-sided tests.|t-test, 2 sided|||Physical Functioning Domain - Change from Baseline at Week 24||||0.918
72481972|NCT02604433|144491283|SUPERIORITY|||||||0.857||||||Significance level of 0.050 for 2-sided tests.|t-test, 2 sided|||General Health Domain - Change from Baseline at Week 24||||0.857
72481973|NCT02604433|144491283|SUPERIORITY|||||||0.839||||||Significance level of 0.050 for 2-sided tests.|t-test, 2 sided|||PCS - Change from Baseline at Week 24||||0.839
72566851|NCT02312713|144664442|SUPERIORITY||Mean Difference (Final Values)|7.74||||0|TWO_SIDED|95.0|3.39|12.08|||Mixed Models Analysis|||This is the comparison between Internet Based Exercise Training and Wait List Control at 12 months for KOOS QOL.||12.08|3.39|0
72566852|NCT02312713|144664442|SUPERIORITY||Mean Difference (Final Values)|3.29||||0.14|TWO_SIDED|95.0|-1.08|7.67|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Wait List Control at 4 months for KOOS QOL.||7.67|-1.08|0.14
72566853|NCT02312713|144664442|SUPERIORITY||Mean Difference (Final Values)|5.15||||0.02|TWO_SIDED|95.0|0.92|9.37|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Wait List Control at 12 months for KOOS QOL.||9.37|0.92|0.02
72566854|NCT02312713|144664443|SUPERIORITY||Mean Difference (Final Values)|-2.58||||0.02|TWO_SIDED|95.0|-4.67|-0.5|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Wait List Control at 4 months.||-0.5|-4.67|0.02
72566855|NCT02312713|144664443|SUPERIORITY||Mean Difference (Final Values)|-1.06||||0.33|TWO_SIDED|95.0|-3.22|1.09|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Wait List Control at 12 months.||1.09|-3.22|0.33
72566856|NCT02312713|144664443|SUPERIORITY||Mean Difference (Final Values)|-0.39||||0.72|TWO_SIDED|95.0|-2.52|1.74|||Mixed Models Analysis|||This is the comparison between Internet Based Exercise Training and Wait List Control at 4 months.||1.74|-2.52|0.72
72566857|NCT02312713|144664443|SUPERIORITY||Mean Difference (Final Values)|0.65||||0.56|TWO_SIDED|95.0|-1.56|2.86|||Mixed Models Analysis|||This is the comparison between Internet Based Exercise Training and Wait List Control at 12 months.||2.86|-1.56|0.56
72566858|NCT02312713|144664443|NON_INFERIORITY|Since there were not sufficient data in prior literature to specific an a priori non-inferiority margin, for this and other secondary outcomes we based conclusions and discussions on magnitude of differences between the group, descriptively. This strategy was specified in the protocol.|Mean Difference (Final Values)|2.19||||0.01|TWO_SIDED|95.0|0.48|3.9|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Internet Based Exercise Training at 4 months.||3.9|0.48|0.01
72566859|NCT02312713|144664443|NON_INFERIORITY|Since there were not sufficient data in prior literature to specific an a priori non-inferiority margin, for this and other secondary outcomes we based conclusions and discussions on magnitude of differences between the group, descriptively. This strategy was specified in the protocol.|Mean Difference (Final Values)|1.71||||0.06|TWO_SIDED|95.0|-0.1|3.52|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Internet-Based Exercise Training at 12 months.||3.52|-0.1|0.06
72566860|NCT02312713|144664444|SUPERIORITY||Mean Difference (Final Values)|-2.47||||0.03|TWO_SIDED|95.0|-4.67|-0.26|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Wait List Control at 4 months.||-0.26|-4.67|0.03
72566861|NCT02312713|144664444|SUPERIORITY||Mean Difference (Final Values)|-2.43||||0.01|TWO_SIDED|95.0|-4.31|-0.55|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Wait List Control at 12 months.||-0.55|-4.31|0.01
72566862|NCT02312713|144664444|SUPERIORITY||Mean Difference (Final Values)|-0.99||||0.39|TWO_SIDED|95.0|-3.24|1.27|||Mixed Models Analysis|||This is the comparison between Internet Based Exercise Training and Wait List Control at 4 months.||1.27|-3.24|0.39
72566863|NCT02312713|144664444|SUPERIORITY||Mean Difference (Final Values)|-1.65||||0.1|TWO_SIDED|95.0|-3.58|0.29|||Mixed Models Analysis|||This is the comparison between Internet Based Exercise Training and Wait List Control at 12 months.||0.29|-3.58|0.1
72566864|NCT02312713|144664444|NON_INFERIORITY|Since there were not sufficient data in prior literature to specific an a priori non-inferiority margin, for this and other secondary outcomes we based conclusions and discussions on magnitude of differences between the group, descriptively. This strategy was specified in the protocol.|Mean Difference (Final Values)|1.48||||0.11|TWO_SIDED|95.0|-0.33|3.29|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Internet Based Exercise Training at 4 months.||3.29|-0.33|0.11
72566865|NCT02312713|144664444|NON_INFERIORITY|Since there were not sufficient data in prior literature to specific an a priori non-inferiority margin, for this and other secondary outcomes we based conclusions and discussions on magnitude of differences between the group, descriptively. This strategy was specified in the protocol.|Mean Difference (Final Values)|0.79||||0.33|TWO_SIDED|95.0|-0.8|2.37|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Internet-Based Exercise Training at 12 months.||2.37|-0.8|0.33
72566866|NCT02312713|144664445|SUPERIORITY||Mean Difference (Final Values)|-0.79||||0.06|TWO_SIDED|95.0|-1.62|0.04|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Wait List Control at 4 months.||0.04|-1.62|0.06
72566867|NCT02312713|144664445|SUPERIORITY||Mean Difference (Net)|0.0||||1|TWO_SIDED|95.0|-0.77|0.77|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Wait List Control at 12 months.||0.77|-0.77|1.00
72566868|NCT02312713|144664445|SUPERIORITY||Mean Difference (Final Values)|-0.44||||0.31|TWO_SIDED|95.0|-1.29|0.41|||Mixed Models Analysis|||This is the comparison between Internet Based Exercise Training and Wait List Control at 4 months.||0.41|-1.29|0.31
72566869|NCT02312713|144664445|SUPERIORITY||Mean Difference (Final Values)|-0.22||||0.58|TWO_SIDED|95.0|-1.01|0.57|||Mixed Models Analysis|||This is the comparison between Internet Based Exercise Training and Wait List Control at 12 months.||0.57|-1.01|0.58
72566870|NCT02312713|144664445|NON_INFERIORITY|Since there were not sufficient data in prior literature to specific an a priori non-inferiority margin, for this and other secondary outcomes we based conclusions and discussions on magnitude of differences between the group, descriptively. This strategy was specified in the protocol.|Mean Difference (Final Values)|0.35||||0.32|TWO_SIDED|95.0|-0.33|1.03|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Internet Based Exercise Training at 4 months.||1.03|-0.33|0.32
72623999|NCT02231580|144778421|SUPERIORITY_OR_OTHER||GLS mean ratio|1.298|||=|0.0522|TWO_SIDED|90.0|1.043|1.614|||MMRM|||Left finger ITI duration statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||1.614|1.043|=0.0522
72624000|NCT02231580|144778421|SUPERIORITY_OR_OTHER||GLS mean ratio|1.014|||=|0.9012|TWO_SIDED|90.0|0.837|1.229|||MMRM|||Right finger ITI duration statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||1.229|0.837|=0.9012
72401997|NCT02515942|144311354|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effecgt|-0.12||||0.5255|TWO_SIDED|80.0|-2.59|2.35|||Mixed Models Analysis|||Change from baseline at Day 15||2.35|-2.59|0.5255
72510585|NCT01520324|144551455|OTHER|The data documented in this trial and the parameters measured were described using classic statistics, i.e. mean, SD, CV(%), median, minimum and maximum values for quantitative variables and frequencies for qualitative variables.||||||||||||||||The number of detected neoplasiae for each patient was listed and summarised by descriptive statistics. Number and percentage of patients with intraepithelial neoplasiae was presented|The data documented in this trial and the parameters measured were described using classic statistics, i.e. mean, SD, CV(%), median, minimum and maximum values for quantitative variables and frequencies for qualitative variables.|||
72510586|NCT01345123|144551476|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0019994|STANDARD_ERROR_OF_MEAN|0.0400918||0.9602|TWO_SIDED|95.0|-0.0765899|0.080588716|||ANCOVA|Covariates: age, gender, Charlson Comorbidity Index, prior year total medical costs pmpm||||.080588716|-.07658990|0.9602
72510587|NCT01345123|144551476|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.013717|STANDARD_ERROR_OF_MEAN|0.04018791||0.7329|TWO_SIDED|95.0|-0.0924947|0.06506063|||ANCOVA|||||0.06506063|-0.0924947|0.7329
72401998|NCT02515942|144311354|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|1.81||||0.1685|TWO_SIDED|80.0|-0.61|4.24|||Mixed Models Analysis|||Change from baseline at Day 15||4.24|-0.61|0.1685
72510588|NCT01345123|144551477|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.805||||0.0511||95.0|0.647|1.001|||Regression, Logistic|Covariates: Age, Gender, Charlson Comorbidity index, calculated risk of knee replacement, hip replacement, herniated disc surgery (score 1-99)||||1.001|0.647|0.0511
72510589|NCT01345123|144551480|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.31257||||0.0106|TWO_SIDED|95.0|0.06895|0.55618|||ANOVA|||||0.55618|0.06895|0.0106
72510590|NCT01345123|144551480|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.15982||||0.0106|TWO_SIDED|95.0|-0.06477|0.38441|||ANOVA|||||0.38441|-0.06477|0.0106
72510591|NCT01345123|144551483|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.009122|STANDARD_ERROR_OF_MEAN|0.0467091||0.8454|TWO_SIDED|95.0|-0.1008434|0.08259938|||ANCOVA|||||0.08259938|-0.1008434|0.8454
72510592|NCT01345123|144551483|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.0183548|STANDARD_ERROR_OF_MEAN|0.04690321||0.6956|TWO_SIDED|95.0|-0.1102961|0.07358642|||ANCOVA|||||0.07358642|-0.1102961|0.6956
72510593|NCT02658994|144551484|SUPERIORITY||Mean Difference (Final Values)|-0.13|||||TWO_SIDED|95.0|-0.33|0.07||||||||0.07|-0.33|
72510594|NCT02658994|144551485|SUPERIORITY||Median Difference (Final Values)|-0.1|||||TWO_SIDED|95.0|-1.39|1.19||||||||1.19|-1.39|
72510595|NCT02658994|144551486|SUPERIORITY||Mean Difference (Final Values)|-0.12|||||TWO_SIDED|95.0|-0.33|0.09||||||||0.09|-0.33|
72510596|NCT02658994|144551487|SUPERIORITY||Mean Difference (Final Values)|0.38|||||TWO_SIDED|95.0|-0.19|0.96||||||Child Bayley scaled receptive score||0.96|-0.19|
72510597|NCT02658994|144551487|SUPERIORITY||Mean Difference (Final Values)|0.03|||||TWO_SIDED|95.0|-0.83|0.9||||||Child Bayley scaled fine motor score||0.90|-0.83|
72510598|NCT02658994|144551488|SUPERIORITY||Risk Ratio (RR)|0.67|||||TWO_SIDED|95.0|0.43|1.05||||||||1.05|0.43|
72401999|NCT02515942|144311354|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment|-2.01||||0.8544|TWO_SIDED|80.0|-4.45|0.43|||Mixed Models Analysis|||Change from baseline at Day 29||0.43|-4.45|0.8544
72510599|NCT02658994|144551489|SUPERIORITY||Risk Ratio (RR)|-0.09|||||TWO_SIDED|95.0|-0.32|0.15||||||Length-for-age z-scores||0.15|-0.32|
72510600|NCT02658994|144551489|SUPERIORITY||Risk Ratio (RR)|-0.12|||||TWO_SIDED|95.0|-0.33|0.1||||||Weight-for-age z-scores||0.10|-0.33|
72510601|NCT00262080|144551514|SUPERIORITY_OR_OTHER_LEGACY|||||||0.037||95.0||||no adjustment was made for multiple comparisons. Treatment effect will be deemed statistically significant if the coefficient for the treatment group within the statistical model is significant at level 0.05.|non-parametric Wilcoxon Rank Sum test|||The primary efficacy analysis compared the TOS at 4 hours post-dosing for patients treated with ecallantide and placebo. Treatment effect was assessed by the non-parametric Wilcoxon Rank Sum test because of an assumed non-normal distribution.||||0.037
72510602|NCT00262080|144551515|SUPERIORITY_OR_OTHER_LEGACY|||||||0.044||95.0||||No adjustment was made for multiple comparisons. Treatment effect will be deemed statistically significant if the coefficient for the treatment group within the statistical model is significant at level 0.05.|Wilcoxon Rank Sum Test.|||The analysis compared the change from baseline in MSCS score at 4 hours post-dosing for patients treated with ecallantide and placebo. Treatment effect was assessed by the non-parametric Wilcoxon Rank Sum test because of an assumed non-normal distribution.||||0.044
72510603|NCT00262080|144551519|SUPERIORITY_OR_OTHER_LEGACY|||||||0.055||95.0||||No adjustment was made for multiple comparisons. Treatment effect will be deemed statistically significant if the coefficient for the treatment group within the statistical model is significant at level 0.05.|Log Rank|||The Log-Rank test was used to compare the time distribution between the two treatment groups.||||0.055
72510604|NCT03100942|144551525|SUPERIORITY||Difference in Response Rates|15.6||||0.1597|TWO_SIDED|95.0|-6.3|37.6||P-values were obtained from Cochran-Mantel-Haenszel (CMH) test stratified by randomization stratification factors.|Cochran-Mantel-Haenszel||For the analysis of the difference in response rates, the data with missing response values were imputed by multiple imputation method with logistic regression.|||37.6|-6.3|0.1597
72510605|NCT03100942|144551525|SUPERIORITY||Difference in Response Rates|16.6||||0.1694|TWO_SIDED|95.0|-5.1|38.3||P-values were obtained from CMH test stratified by randomization stratification factors.|Cochran-Mantel-Haenszel||For the analysis of the difference in response rates, the data with missing response values were imputed by multiple imputation method with logistic regression.|||38.3|-5.1|0.1694
72402000|NCT02515942|144311354|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|2.03||||0.1402|TWO_SIDED|80.0|-0.38|4.44|||Mixed Models Analysis|||Change from baseline at Day 29||4.44|-0.38|0.1402
72402001|NCT02515942|144311354|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|4.03||||0.015|TWO_SIDED|80.0|1.67|6.4|||Mixed Models Analysis|||Change from baseline at Day 29||6.40|1.67|0.0150
72481974|NCT02604433|144491286|SUPERIORITY||Odds Ratio (OR)|7.6||||0.0015|TWO_SIDED|95.0|1.8|32.9||Significance level of 0.050 for 2-sided tests.|Cochran-Mantel-Haenszel|||Odds ratio 95% confidence intervals (CIs), and p-value were estimated from the Cochran Mantel-Haenszel (CMH) test stratified by the geographical regions defined at randomization.||32.9|1.8|0.0015
72481975|NCT02604433|144491289|SUPERIORITY||Mean Difference (Final Values)|-67.27||||0.0195|TWO_SIDED|95.0|-123.63|-10.91||Significance level of 0.050 for 2-sided tests.|t-test, 2 sided||luspatercept - placebo|≥ 33% Transfusion Burden Reduction||-10.91|-123.63|0.0195
72481976|NCT02604433|144491289|SUPERIORITY||Mean Difference (Final Values)|28.24||||0.7473|TWO_SIDED|95.0|-144.87|201.34||Significance level of 0.050 for 2-sided tests.|t-test, 2 sided||luspatercept - placebo|≥ 50% Transfusion Burden Reduction||201.34|-144.87|0.7473
72481977|NCT00078754|144491326|SUPERIORITY_OR_OTHER_LEGACY|||||||0.622|TWO_SIDED||||||ANCOVA|||||||0.622
72481978|NCT00078754|144491327|SUPERIORITY|||||||0.029||||||LHA score main effect.|ANCOVA|The LHA Score F\[1,83\] = 4.91, p = 0.029; Condition F\[2,83\] = 0.20, p = 0.815; Condition x LHA Score F\[2,83\] = 0.255, p = 0.799.||The hypothesis was that subjects with LHA Scores = 18 or more would respond better to divalproex (than fluoxetine) while those with LHA scores = or \< 17 would respond better to fluoxetine (than divalproex).||||0.029
72481979|NCT00078754|144491327|SUPERIORITY||Mean Difference (Final Values)|19.0|STANDARD_ERROR_OF_MEAN|2.7||0.8|TWO_SIDED||||||ANCOVA|Baseline OAS-M Aggression score as covariate.||ANCOVA at endpoint with baseline OAS-M AGG score as covariate.||||0.80
72481980|NCT00752622|144491345|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||Comparison of Infliximab from Induction baseline to evaluation Week 10.||||<.0001
72481981|NCT00752622|144491345|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||Comparison of Infliximab from Induction baseline to Week 30 of the Observational Phase.||||<.0001
72481982|NCT00752622|144491345|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||Comparison of Infliximab from Induction baseline to Week 54 of the Observational Phase.||||<.0001
72481983|NCT00267631|144491367|SUPERIORITY_OR_OTHER|||||||0.026||95.0|||||Chi-squared|||||||.026
72481984|NCT01777269|144491428|SUPERIORITY_OR_OTHER||Adjusted mean difference|-8.0|||<|0.001|TWO_SIDED|95.0|-10.22|-5.79|||mixed-model repeated-measures|||||-5.79|-10.22|<0.001
72481985|NCT01777269|144491429|SUPERIORITY_OR_OTHER||Adjusted mean difference|-4.11|||<|0.001|TWO_SIDED|95.0|-6.01|-2.21|||mixed-model repeated-measures||Month 1|||-2.21|-6.01|<0.001
72481986|NCT01777269|144491429|SUPERIORITY_OR_OTHER||Adjusted mean difference|-6.43|||<|0.001|TWO_SIDED|95.0|-8.45|-4.41|||Adjusted mean difference||Month 3|||-4.41|-8.45|<0.001
72510606|NCT03100942|144551525|SUPERIORITY||Difference in Response Rates|8.1||||0.3309|TWO_SIDED|95.0|-13.2|29.4||P-values were obtained from CMH test stratified by randomization stratification factors.|Cochran-Mantel-Haenszel||For the analysis of the difference in response rates, the data with missing response values were imputed by multiple imputation method with logistic regression.|||29.4|-13.2|0.3309
72624001|NCT02231580|144778422|SUPERIORITY_OR_OTHER||GLS mean ratio|1.198|||=|0.1779|TWO_SIDED|90.0|0.96|1.494|||MMRM|||Left finger TF statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||1.494|0.96|=0.1779
72624002|NCT02231580|144778422|SUPERIORITY_OR_OTHER||GLS mean ratio|0.966|||=|0.8036|TWO_SIDED|90.0|0.765|1.22|||MMRM|||Right finger TF statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||1.220|0.765|=0.8036
72481987|NCT01777269|144491429|SUPERIORITY_OR_OTHER||Adjusted mean difference|-9.04|||<|0.001|TWO_SIDED|95.0|-11.31|-6.77|||mixed-model repeated-measures||Month 6|||-6.77|-11.31|<0.001
72481988|NCT01777269|144491429|SUPERIORITY_OR_OTHER||Adjusted mean difference|-8.82|||<|0.001|TWO_SIDED|95.0|-10.96|-6.67|||mixed-model repeated-measures||Month 9|||-6.67|-10.96|<0.001
72481989|NCT01777269|144491431|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.2||||0.37|TWO_SIDED|95.0|-0.62|0.23|||mixed-model repeated-measures||Month 1|||0.23|-0.62|0.37
72481990|NCT01777269|144491431|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.24||||0.33|TWO_SIDED|95.0|-0.71|0.24|||mixed-model repeated-measures||Month 3|||0.24|-0.71|0.33
72481991|NCT01777269|144491431|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.37||||0.16|TWO_SIDED|95.0|-0.88|0.15|||mixed-model repeated-measures||Month 6|||0.15|-0.88|0.16
72481992|NCT01777269|144491431|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.68||||0.009|TWO_SIDED|95.0|-1.19|-0.17|||mixed-model repeated-measures||Month 9|||-0.17|-1.19|0.009
72481993|NCT01777269|144491431|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.46||||0.091|TWO_SIDED|95.0|-0.99|0.07|||mixed-model repeated-measures||Month 12|||0.07|-0.99|0.091
72481994|NCT01777269|144491432|SUPERIORITY_OR_OTHER||Adjusted mean difference|-2.89|||<|0.001|TWO_SIDED|95.0|-4.07|-1.7|||mixed-model repeated-measures||Month 1|||-1.70|-4.07|<0.001
72481995|NCT01777269|144491432|SUPERIORITY_OR_OTHER||Adjusted mean difference|-5.24|||<|0.001|TWO_SIDED|95.0|-6.59|-3.9|||mixed-model repeated-measures||Month 3|||-3.90|-6.59|<0.001
72481996|NCT01777269|144491432|SUPERIORITY_OR_OTHER||Adjusted mean difference|-6.82|||<|0.001|TWO_SIDED|95.0|-8.3|-5.34|||mixed-model repeated-measures||Month 6|||-5.34|-8.30|<0.001
72481997|NCT01777269|144491432|SUPERIORITY_OR_OTHER||Adjusted mean difference|-7.05|||<|0.001|TWO_SIDED|95.0|-8.51|-5.59|||mixed-model repeated-measures||Month 9|||-5.59|-8.51|<0.001
72566871|NCT02312713|144664445|NON_INFERIORITY|Since there were not sufficient data in prior literature to specific an a priori non-inferiority margin, for this and other secondary outcomes we based conclusions and discussions on magnitude of differences between the group, descriptively. This strategy was specified in the protocol.|Mean Difference (Final Values)|-0.22||||0.51|TWO_SIDED|95.0|-0.86|0.43|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Internet-Based Exercise Training at 12 months.||0.43|-0.86|0.51
72402002|NCT02515942|144311354|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|0.14||||0.4682|TWO_SIDED|80.0|-2.11|2.39|||Mixed Models Analysis|||Change from baseline at Day 30||2.39|-2.11|0.4682
72481998|NCT01777269|144491432|SUPERIORITY_OR_OTHER||Adjusted mean difference|-6.92|||<|0.001|TWO_SIDED|95.0|-8.47|-5.38|||mixed-model repeated-measures||Month 12|||-5.38|-8.47|<0.001
72481999|NCT01777269|144491433|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.94||||0.012|TWO_SIDED|95.0|-1.67|-0.21|||mixed-model repeated-measures||Month 1|||-0.21|-1.67|0.012
72566872|NCT02312713|144664446|SUPERIORITY||Mean Difference (Final Values)|6.95||||0.48|TWO_SIDED|95.0|-12.31|26.22|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Wait List Control at 4 months.||26.22|-12.31|0.48
72566873|NCT02312713|144664446|SUPERIORITY||Mean Difference (Final Values)|7.11||||0.41|TWO_SIDED|95.0|-9.69|23.91|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Wait List Control at 12 months.||23.91|-9.69|0.41
72566874|NCT02312713|144664446|SUPERIORITY||Mean Difference (Final Values)|-6.82||||0.5|TWO_SIDED|95.0|-26.55|12.91|||Mixed Models Analysis|||This is the comparison between Internet Based Exercise Training and Wait List Control at 4 months.||12.91|-26.55|0.50
72566875|NCT02312713|144664446|SUPERIORITY||Mean Difference (Final Values)|7.02||||0.43|TWO_SIDED|95.0|-10.31|24.35|||Mixed Models Analysis|||This is the comparison between Internet Based Exercise Training and Wait List Control at 12 months.||24.35|-10.31|0.43
72566876|NCT02312713|144664446|NON_INFERIORITY|Since there were not sufficient data in prior literature to specific an a priori non-inferiority margin, for this and other secondary outcomes we based conclusions and discussions on magnitude of differences between the group, descriptively. This strategy was specified in the protocol.|Mean Difference (Final Values)|-13.77||||0.09|TWO_SIDED|95.0|-29.73|2.19|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Internet Based Exercise Training at 4 months.||2.19|-29.73|0.09
72566877|NCT02312713|144664446|NON_INFERIORITY|Since there were not sufficient data in prior literature to specific an a priori non-inferiority margin, for this and other secondary outcomes we based conclusions and discussions on magnitude of differences between the group, descriptively. This strategy was specified in the protocol.|Mean Difference (Final Values)|-0.09||||0.99|TWO_SIDED|95.0|-14.41|14.23|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Internet-Based Exercise Training at 12 months.||14.23|-14.41|0.99
72482000|NCT01777269|144491433|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.93||||0.017|TWO_SIDED|95.0|-1.69|-0.17|||mixed-model repeated-measures||Month 3|||-0.17|-1.69|0.017
72482001|NCT01777269|144491433|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.73|||<|0.001|TWO_SIDED|95.0|-2.57|-0.88|||mixed-model repeated-measures||Month 6|||-0.88|-2.57|<0.001
72482002|NCT01777269|144491433|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.15||||0.009|TWO_SIDED|95.0|-2.01|-0.3|||mixed-model repeated-measures||Month 9|||-0.30|-2.01|0.009
72566878|NCT02312713|144664447|SUPERIORITY||Mean Difference (Final Values)|1.36||||0.04|TWO_SIDED|95.0|0.05|2.66|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Wait List Control at 4 months for Strengthening Exercises||2.66|0.05|0.04
72482003|NCT01777269|144491433|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.83||||0.047|TWO_SIDED|95.0|-1.65|-0.01|||mixed-model repeated-measures||Month 12|||-0.01|-1.65|0.047
72482004|NCT01777269|144491434|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.65|||<|0.001|TWO_SIDED|95.0|-2.45|-0.85|||mixed-model repeated-measures||Week 2|||-0.85|-2.45|<0.001
72482005|NCT01777269|144491434|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.55||||0.24|TWO_SIDED|95.0|-1.47|0.37|||mixed-model repeated-measures||Month 1|||0.37|-1.47|0.24
72482006|NCT01777269|144491434|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.27||||0.006|TWO_SIDED|95.0|-2.19|-0.36|||mixed-model repeated-measures||Month 3|||-0.36|-2.19|0.006
72482007|NCT01777269|144491434|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.73|||<|0.001|TWO_SIDED|95.0|-2.74|-0.72|||mixed-model repeated-measures||Month 6|||-0.72|-2.74|<0.001
72482008|NCT01777269|144491434|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.34||||0.013|TWO_SIDED|95.0|-2.4|-0.28|||mixed-model repeated-measures||Month 9|||-0.28|-2.40|0.013
72482009|NCT01777269|144491434|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.97|||<|0.001|TWO_SIDED|95.0|-3.12|-0.83|||mixed-model repeated-measures||Month 12|||-0.83|-3.12|<0.001
72482010|NCT01777269|144491435|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.4||||0.036|TWO_SIDED|95.0|-0.78|-0.03|||mixed-model repeated-measures||Week 2|||-0.03|-0.78|0.036
72566879|NCT02312713|144664447|SUPERIORITY||Mean Difference (Final Values)|1.21||||0.09|TWO_SIDED|95.0|-0.18|2.6|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Wait List Control at 12 months for Strengthening Exercises.||2.6|-0.18|0.09
72566880|NCT02312713|144664447|SUPERIORITY||Mean Difference (Final Values)|0.85||||0.22|TWO_SIDED|95.0|-0.49|2.19|||Mixed Models Analysis|||This is the comparison between Internet Based Exercise Training and Wait List Control at 4 months for Strengthening Exercises.||2.19|-0.49|0.22
72482011|NCT01777269|144491435|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.0||||1|TWO_SIDED|95.0|-0.37|0.37|||mixed-model repeated-measures||Month 1|||0.37|-0.37|1.00
72482012|NCT01777269|144491435|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.26||||0.21|TWO_SIDED|95.0|-0.67|0.15|||mixed-model repeated-measures||Month 3|||0.15|-0.67|0.21
72402003|NCT02515942|144311354|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|0.38||||0.4125|TWO_SIDED|80.0|-1.84|2.6|||Mixed Models Analysis|||Change from baseline at Day 30||2.60|-1.84|0.4125
72482013|NCT01777269|144491435|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.62||||0.009|TWO_SIDED|95.0|-1.09|-0.15|||mixed-model repeated-measures||Month 6|||-0.15|-1.09|0.009
72482014|NCT01777269|144491435|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.45||||0.056|TWO_SIDED|95.0|-0.91|0.01|||mixed-model repeated-measures||Month 9|||0.01|-0.91|0.056
72482015|NCT01777269|144491435|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.58||||0.023|TWO_SIDED|95.0|-1.08|-0.08|||mixed-model repeated-measures||Month 12|||-0.08|-1.08|0.023
72482016|NCT01777269|144491436|SUPERIORITY_OR_OTHER||Adjusted mean difference|-3.0|||<|0.001|TWO_SIDED|95.0|-3.89|-2.1|||mixed-model repeated-measures||Week 2|||-2.10|-3.89|<0.001
72510607|NCT03100942|144551526|SUPERIORITY||LS Mean Difference|1.3|STANDARD_ERROR_OF_MEAN|1.05||0.2066|TWO_SIDED|95.0|-0.7|3.4|||MMRM|||Least Squares (LS) Means, 95% confidence interval (CI), and P-values were obtained from Mixed Effects Model for Repeated Measures (MMRM) with the terms for baseline value, treatment, stratification factors, visit, and treatment-by-visit interaction.||3.4|-0.7|0.2066
72510608|NCT03100942|144551526|SUPERIORITY||LS Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|1.04||0.3998|TWO_SIDED|95.0|-2.9|1.2|||MMRM|||LS Means, 95% CI, and P-values were obtained from MMRM with the terms for baseline value, treatment, stratification factors, visit, and treatment-by-visit interaction.||1.2|-2.9|0.3998
72510609|NCT03100942|144551526|SUPERIORITY||LS Mean Difference|0.7|STANDARD_ERROR_OF_MEAN|1.04||0.5113|TWO_SIDED|95.0|-1.4|2.7|||MMRM|||LS Means, 95% CI, and P-values were obtained from MMRM with the terms for baseline value, treatment, stratification factors, visit, and treatment-by-visit interaction.||2.7|-1.4|0.5113
72510610|NCT03100942|144551527|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.47||0.9446|TWO_SIDED|95.0|-0.9|1.0|||MMRM|||LS Means, 95% CI, and P-values were obtained from MMRM with the terms for baseline value, treatment, stratification factors, visit, and treatment-by-visit interaction.||1.0|-0.9|0.9446
72510611|NCT03100942|144551527|SUPERIORITY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.47||0.3977|TWO_SIDED|95.0|-1.3|0.5|||MMRM|||LS Means, 95% CI, and P-values were obtained from MMRM with the terms for baseline value, treatment, stratification factors, visit, and treatment-by-visit interaction.||0.5|-1.3|0.3977
72510612|NCT03100942|144551527|SUPERIORITY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.47||0.4966|TWO_SIDED|95.0|-1.2|0.6|||MMRM|||LS Means, 95% CI, and P-values were obtained from MMRM with the terms for baseline value, treatment, stratification factors, visit, and treatment-by-visit interaction.||0.6|-1.2|0.4966
72510613|NCT03100942|144551528|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|1.1||0.9564|TWO_SIDED|95.0|-2.2|2.1|||MMRM|||LS Means, 95% CI, and P-values were obtained from MMRM with the terms for baseline value, treatment, stratification factors, visit, and treatment-by-visit interaction.||2.1|-2.2|0.9564
72510614|NCT03100942|144551528|SUPERIORITY||LS Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|1.07||0.2788|TWO_SIDED|95.0|-3.3|0.9|||MMRM|||LS Means, 95% CI, and P-values were obtained from MMRM with the terms for baseline value, treatment, stratification factors, visit, and treatment-by-visit interaction.||0.9|-3.3|0.2788
72510615|NCT03100942|144551528|SUPERIORITY||LS Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|1.06||0.8047|TWO_SIDED|95.0|-1.8|2.3|||MMRM|||LS Means, 95% CI, and P-values were obtained from MMRM with the terms for baseline value, treatment, stratification factors, visit, and treatment-by-visit interaction.||2.3|-1.8|0.8047
72566881|NCT02312713|144664447|SUPERIORITY||Mean Difference (Final Values)|1.35||||0.06|TWO_SIDED|95.0|-0.08|2.78|||Mixed Models Analysis|||This is the comparison between Internet Based Exercise Training and Wait List Control at 12 months for Strengthening Exercises.||2.78|-0.08|0.06
72482017|NCT01777269|144491436|SUPERIORITY_OR_OTHER||Adjusted mean difference|-2.1|||<|0.001|TWO_SIDED|95.0|-3.15|-1.06|||mixed-model repeated-measures||Month 1|||-1.06|-3.15|<0.001
72482018|NCT01777269|144491436|SUPERIORITY_OR_OTHER||Adjusted mean difference|-2.11|||<|0.001|TWO_SIDED|95.0|-3.25|-0.98|||mixed-model repeated-measures||Month 3|||-0.98|-3.25|<0.001
72482019|NCT01777269|144491436|SUPERIORITY_OR_OTHER||Adjusted mean difference|-2.53|||<|0.001|TWO_SIDED|95.0|-3.76|-1.3|||mixed-model repeated-measures||Month 6|||-1.30|-3.76|<0.001
72510616|NCT03100942|144551529|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.46||0.6782|TWO_SIDED|95.0|-1.1|0.7|||MMRM|||LS Means, 95% CI, and P-values were obtained from MMRM with the terms for baseline value, treatment, stratification factors, visit, and treatment-by-visit interaction.||0.7|-1.1|0.6782
72482020|NCT01777269|144491436|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.3||||0.042|TWO_SIDED|95.0|-2.56|-0.05|||mixed-model repeated-measures||Month 9|||-0.05|-2.56|0.042
72482021|NCT01777269|144491436|SUPERIORITY_OR_OTHER||Adjusted mean difference|-3.51|||<|0.001|TWO_SIDED|95.0|-4.87|-2.14|||mixed-model repeated-measures||Month 12|||-2.14|-4.87|<0.001
72482022|NCT01777269|144491437|SUPERIORITY_OR_OTHER||Adjusted mean difference|-7.78|||<|0.001|TWO_SIDED|95.0|-10.07|-5.49|||mixed-model repeated-measures||Par. with IPSS change from baseline \>=2 points improvement at any time post-baseline visit|||-5.49|-10.07|<0.001
72482023|NCT01777269|144491437|SUPERIORITY_OR_OTHER||Adjusted mean difference|-7.39|||<|0.001|TWO_SIDED|95.0|-9.79|-4.99|||mixed-model repeated-measures||Par. with IPSS change from baseline \>=3 points improvement at any time post-baseline visit|||-4.99|-9.79|<0.001
72566882|NCT02312713|144664447|NON_INFERIORITY|Since there were not sufficient data in prior literature to specific an a priori non-inferiority margin, for this and other secondary outcomes we based conclusions and discussions on magnitude of differences between the group, descriptively. This strategy was specified in the protocol.|Mean Difference (Final Values)|-0.51||||0.36|TWO_SIDED|95.0|-1.6|0.58|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Internet Based Exercise Training at 4 months for Strength.||0.58|-1.6|0.36
72482024|NCT01777269|144491438|SUPERIORITY_OR_OTHER||Adjusted mean difference|-7.79|||<|0.001|TWO_SIDED|95.0|-10.22|-5.35|||mixed-model repeated-measures||Par. with IPSS change from baseline \>=25 points improvement at any time post-baseline visit|||-5.35|-10.22|<0.001
72482025|NCT00504881|144491440|SUPERIORITY_OR_OTHER||Percent Reduction over Placebo|7.3|||=|0.125|TWO_SIDED|95.0|-2.2|15.9|||ANCOVA|||ANCOVA on log-transformed partial seizure frequency per week over the treatment period, with log-transformed baseline seizure frequency per week as covariate, and including terms for treatment and stratification factors.||15.9|-2.2|=0.125
72482026|NCT00803270|144491465|SUPERIORITY_OR_OTHER||Difference of proportions|0.08|STANDARD_ERROR_OF_MEAN|0.19||0.99|TWO_SIDED|95.0|-0.28|0.44|||Fisher Exact|||||0.44|-0.28|0.99
72482027|NCT00803270|144491466|SUPERIORITY_OR_OTHER||difference of proportions|0.45|STANDARD_ERROR_OF_MEAN|0.21||0.08|TWO_SIDED|95.0|0.03|0.87||Fisher's Exact Test of equality of percent meeting optimal outcome.|Fisher Exact|||||0.87|0.03|0.08
72482028|NCT00593957|144491477|SUPERIORITY_OR_OTHER||||||<|0.4|||||||t-test, 2 sided|||||||<0.40
72482029|NCT00593957|144491477|SUPERIORITY_OR_OTHER||||||<|0.62||95.0|||||t-test, 2 sided|||||||<0.62
72482030|NCT00593957|144491477|SUPERIORITY_OR_OTHER||||||<|0.38||95.0|||||t-test, 2 sided|||||||<0.38
72482031|NCT00593957|144491479|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.38|||<|0.1|||||||ANOVA|||Null hypothesis is that there would be no significant difference in social abilities as measured by the SSI score in this treatment group baseline to 6 months post-treatment.||||<0.10
72482032|NCT00593957|144491479|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.5|||<|0.5|||||||ANOVA|||||||<0.50
72482033|NCT00593957|144491479|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.0|||<|0.48|||||||ANOVA|||||||<0.48
72482034|NCT00593957|144491480|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.947|||<|0.05|||||||ANOVA|||||||<0.05
72482035|NCT01163721|144491541|SUPERIORITY_OR_OTHER||difference in least squares mean (LSM)|-0.53|STANDARD_ERROR_OF_MEAN|0.2||0.01|TWO_SIDED|95.0|-0.93|-0.13||P-value is from an Analysis of Covariance (ANCOVA) model with treatment as factor and baseline HbA1c value as covariate. Due to the exploratory nature of this study, there were no adjustments for multiplicity.|ANCOVA|||Assuming a common standard deviation of 1.1%, 60 evaluable participants would provide 93% power to detect a statistically significant -1.0% difference in change from baseline HbA1c at Week 12 between ranolazine and placebo (2-sided alpha = 0.05). 80 participants were randomized to ensure at least 60 evaluable participants.||-0.13|-0.93|0.010
72482036|NCT01163721|144491542|SUPERIORITY_OR_OTHER||difference in LSM|-15.4|STANDARD_ERROR_OF_MEAN|12.83||0.234|TWO_SIDED|95.0|-41.0|10.2||P-value is from an ANCOVA model with treatment and baseline HbA1c stratification as factors and baseline value as covariate.|ANCOVA|||||10.2|-41.0|0.234
72482037|NCT01163721|144491543|SUPERIORITY_OR_OTHER||difference in least squares mean (LSM)|-2.5|STANDARD_ERROR_OF_MEAN|9.38||0.794|TWO_SIDED|95.0|-21.1|16.2||P-value is from an ANCOVA model with treatment and baseline HbA1c stratification as factors and baseline value as covariate.|ANCOVA|||||16.2|-21.1|0.794
72510617|NCT03100942|144551529|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.45||0.9171|TWO_SIDED|95.0|-0.8|0.9|||MMRM|||LS Means, 95% CI, and P-values were obtained from MMRM with the terms for baseline value, treatment, stratification factors, visit, and treatment-by-visit interaction.||0.9|-0.8|0.9171
72482038|NCT01786239|144491544|SUPERIORITY_OR_OTHER|||||||0.0493|||||||Mixed Models Analysis|||||||0.0493
72482039|NCT02511678|144491545|SUPERIORITY|||||||0.0746||||||The 1-sided p-value was based on a t-test against a performance goal of -2.|t-test, 1 sided|||||||0.0746
72482040|NCT01295281|144491555|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|"Two catheters were tested regarding subjects' perception when using them, in a cross over design. After using each catheter for 1 week the subjects were asked: Do you experience discomfort when using your catheter?, and the subjects were supposed to answer Yes or No. The hypothesis to be investigated was that the tolerability/perception was about the same for each type of catheter, i.e. the POBE 2.0 should be non-inferior compared to PVC. H0: p(disc. POBE - Yes) = p(disc. PVC - Yes)"||||||0.0066|||||||McNemar|||The size of the target population was estimated by calculating 95% Confidence Interval (CI) of a possible difference between the two catheter types. The width of the interval was decided on the proportion of patients who would prefer one or the other catheter. Max width was seen when both proportions were 0.5. A total of 90 evaluable subjects limited the maximum width to 0.41, which was considered narrow enough from a scientific point of view, why this sample size was used in the study.||||0.0066
72482041|NCT05461794|144491588|OTHER||Odds Ratio (OR)|2.1|||||TWO_SIDED|95.0|0.3|23.9|||||The crude odds ratio was estimated along with exact unconditional 95% CIs constructed by the tail method based on the score statistics.|||23.9|0.3|
72482042|NCT05461794|144491588|OTHER||Risk Difference (RD)|5.0|||||TWO_SIDED|95.0|-9.3|19.5|||||The risk difference was estimated along with their exact unconditional 95% CIs constructed by the tail method based on the score statistics.|||19.5|-9.3|
72482043|NCT05461794|144491590|OTHER||Hazard Ratio (HR)|0.85|||||TWO_SIDED|95.0|0.45|1.61|||||Hazard ratio and 95% CIs were estimated using a Cox regression model stratified by PD-L1 tumor area positivity score (\>=10% versus \< 10%)|||1.61|0.45|
72482044|NCT05461794|144491591|OTHER||Odds Ratio (OR)|2.5|||||TWO_SIDED|95.0|0.9|6.8|||||The crude odds ratio was estimated along with exact unconditional 95% CIs constructed by the tail method based on the score statistics|||6.8|0.9|
72482045|NCT05461794|144491591|OTHER||Odds Ratio (OR)|1.0|||||TWO_SIDED|95.0|0.3|3.7|||||The odds ratio was estimated along with their exact unconditional 95% CIs constructed by the tail method based on the score statistics.|||3.7|0.3|
72482046|NCT05461794|144491591|OTHER||Risk Difference (RD)|22.0|||||TWO_SIDED|95.0|-1.5|43.3|||||The risk difference was estimated along with their exact unconditional 95% CIs constructed by the tail method based on the score statistics.|||43.3|-1.5|
72482047|NCT05461794|144491591|OTHER||Risk Difference (RD)|0.9|||||TWO_SIDED|95.0|-24.5|28.4|||||The risk difference was estimated along with their exact unconditional 95% CIs constructed by the tail method based on the score statistics.|||28.4|-24.5|
72482048|NCT05461794|144491592|OTHER||Odds Ratio (OR)|3.9|||||TWO_SIDED|95.0|0.7|40.8|||||The crude odds ratio was estimated along with exact unconditional 95% CIs constructed by the tail method based on the score statistics.|||40.8|0.7|
72624003|NCT02231580|144778423|SUPERIORITY_OR_OTHER||GLS mean ratio|0.812|||=|0.0177|TWO_SIDED|90.0|0.706|0.935|||MMRM|||Left finger freq statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||0.935|0.706|=0.0177
72402004|NCT02515942|144311354|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|0.24||||0.4431|TWO_SIDED|80.0|-1.94|2.42|||Mixed Models Analysis|||Change from baseline at Day 30||2.42|-1.94|0.4431
72402005|NCT02515942|144311354|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-1.04||||0.6924|TWO_SIDED|80.0|-3.72|1.63|||Mixed Models Analysis|||Change from baseline at Day 57||1.63|-3.72|0.6924
72482049|NCT05461794|144491592|OTHER||Odds Ratio (OR)|0.6|||||TWO_SIDED|95.0|0.1|2.9|||||The odds ratio was estimated along with their exact unconditional 95% CIs constructed by the tail method based on the score statistics.|||2.9|0.1|
72482050|NCT05461794|144491592|OTHER||Risk Difference (RD)|12.7|||||TWO_SIDED|95.0|-2.3|29.5|||||The risk difference was estimated along with their exact unconditional 95% CIs constructed by the tail method based on the score statistics.|||29.5|-2.3|
72482051|NCT05461794|144491592|OTHER||Risk Difference (RD)|-8.4|||||TWO_SIDED|95.0|-34.7|13.8|||||The risk difference was estimated along with their exact unconditional 95% CIs constructed by the tail method based on the score statistics.|||13.8|-34.7|
72482052|NCT05461794|144491593|OTHER||Hazard Ratio (HR)|0.53|||||TWO_SIDED|95.0|0.29|0.96|||||Hazard ratio and 95% CIs were estimated using a Cox regression model stratified by the selected stratification factors PD-L1 tumor area positivity score (\>=10% versus \< 10%)|||0.96|0.29|
72482053|NCT05461794|144491593|OTHER||Hazard Ratio (HR)|1.96|||||TWO_SIDED|95.0|0.79|4.82|||||Hazard ratio and 95% CIs were estimated using a Cox regression model stratified by the selected stratification factors PD-L1 tumor area positivity score (\>=10% versus \< 10%)|||4.82|0.79|
72482054|NCT05461794|144491594|OTHER||Odds Ratio (OR)|0.4|||||TWO_SIDED|95.0|0.1|2.7|||||The crude odds ratio was estimated along with exact unconditional 95% CIs constructed by the tail method based on the score statistics|||2.7|0.1|
72482055|NCT00467285|144491596|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||t-test, 2 sided|||comparison of changes in BMD at 6months compared to baseline||||<0.05
72482056|NCT03714425|144491645|SUPERIORITY||||||<|0.05||||||The primary research objective to measure perceived improvement in pain at three months was assessed using a two-sample t-test of PGIC scores between the two treatment groups using a type I error rate of 0.05 (two-sided).|t-test, 2 sided|Most of the analyses involved delta scores reflecting changes within subjects, though we compared PGIC raw scores rather than change scores.||||||<0.05
72482057|NCT03019796|144491647|OTHER|||||||0.04|||||||ANOVA|repeated measures||||||0.040
72510618|NCT03100942|144551529|SUPERIORITY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.45||0.4641|TWO_SIDED|95.0|-1.2|0.5|||MMRM|||LS Means, 95% CI, and P-values were obtained from MMRM with the terms for baseline value, treatment, stratification factors, visit, and treatment-by-visit interaction.||0.5|-1.2|0.4641
72482058|NCT03019796|144491648|OTHER|||||||0.054|||||||ANOVA|repeated measures||||||0.054
72482059|NCT03019796|144491649|OTHER|||||||0.04|||||||ANOVA|REPEATED MEASURES||||||0.040
72402006|NCT02515942|144311354|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-0.61||||0.616|TWO_SIDED|80.0|-3.26|2.04|||Mixed Models Analysis|||Change from baseline at Day 57||2.04|-3.26|0.6160
72482060|NCT03019796|144491650|OTHER|||||||0.321|||||||ANOVA|REPEATED MEASURES||||||0.321
72482061|NCT03019796|144491651|OTHER|||||||0.401|||||||ANOVA|REPEATED MEASURES||||||0.401
72482062|NCT03019796|144491652|OTHER|||||||0.021|||||||ANOVA|REPEATED MEASURES||||||0.021
72482063|NCT00475033|144491701|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower limit of the 2-sided 95% CI for the difference between the 2 treatment groups was \> -10%.|Difference|-2.4|||||TWO_SIDED|95.0|-5.3|-0.1|||||Exact 2-sided CI for the difference in proportions (13vPnC, 7vPnC) expressed as a percentage.|Meningococcal C: Difference in proportions (13vPnC, 7vPnC) expressed as a percentage.||-0.1|-5.3|
72482064|NCT00475033|144491702|SUPERIORITY_OR_OTHER||Ratio of geometric means|1.19|||||TWO_SIDED|95.0|0.96|1.48|||||CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).|Ratio of GMs (13vPnC, 7vPnC)||1.48|0.96|
72482065|NCT00475033|144491703|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower limit of the 2-sided 95% CI for the difference between the 2 treatment groups was \> -10%.|Difference|0.0|||||TWO_SIDED|95.0|-1.6|1.7|||||Exact 2-sided CI for the difference in proportions (13vPnC, 7vPnC) expressed as a percentage.|PT: Difference in proportions (13vPnC, 7vPnC) expressed as a percentage.||1.7|-1.6|
72482066|NCT00475033|144491703|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower limit of the 2-sided 95% CI for the difference between the 2 treatment groups was \> -10%.|Difference|0.0|||||TWO_SIDED|95.0|-1.3|1.3|||||Exact 2-sided CI for the difference in proportions (13vPnC, 7vPnC) expressed as a percentage.|FHA: Difference in proportions (13vPnC, 7vPnC) expressed as a percentage.||1.3|-1.3|
72510619|NCT04009096|144551530|OTHER|||||||0.14||||||Two tailed p value reported for Mann-Whitney test comparing controls with each vaccinees|Wilcoxon (Mann-Whitney)|||Comparison of pooled data from Groups 1, 2 and 3 volunteers who completed CHMI with pooled data of infectivity controls (unvaccinated) from CHMI study running in parallel (VAC069 study)||||0.14
72510620|NCT05151471|144551535|SUPERIORITY|||||||0.78|||||||Log Rank|||||||0.78
72624004|NCT02231580|144778423|SUPERIORITY_OR_OTHER||GLS mean ratio|0.967|||=|0.6491|TWO_SIDED|90.0|0.856|1.093|||MMRM|||Right finger freq statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||1.093|0.856|=0.6491
72624005|NCT02231580|144778424|SUPERIORITY_OR_OTHER||GLS mean ratio|1.168|||=|0.6176|TWO_SIDED|90.0|0.697|1.955|||MMRM|||Left hand IOI variability statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||1.955|0.697|=0.6176
72624006|NCT02231580|144778424|SUPERIORITY_OR_OTHER||GLS mean ratio|0.759|||=|0.4541|TWO_SIDED|90.0|0.411|1.399|||MMRM|||Right hand IOI variability statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||1.399|0.411|=0.4541
72624007|NCT02231580|144778424|SUPERIORITY_OR_OTHER||GLS mean ratio|1.119|||=|0.2018|TWO_SIDED|90.0|0.967|1.294|||MMRM|||Left hand IOI duration statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||1.294|0.967|=0.2018
72624008|NCT02231580|144778424|SUPERIORITY_OR_OTHER||GLS mean ratio|1.046|||=|0.6527|TWO_SIDED|90.0|0.886|1.234|||MMRM|||Right hand IOI duration statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||1.234|0.886|=0.6527
72624009|NCT02231580|144778425|SUPERIORITY_OR_OTHER||GLS mean ratio|0.929|||=|0.8279|TWO_SIDED|90.0|0.529|1.63|||MMRM|||Left hand variability of TD statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||1.630|0.529|=0.8279
72624010|NCT02231580|144778425|SUPERIORITY_OR_OTHER||GLS mean ratio|0.612|||=|0.2738|TWO_SIDED|90.0|0.292|1.283|||MMRM|||Right hand variability of TD statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||1.283|0.292|=0.2738
72624011|NCT02231580|144778425|SUPERIORITY_OR_OTHER||GLS mean ratio|1.018|||=|0.9218|TWO_SIDED|90.0|0.752|1.378|||MMRM|||Left hand duration of TD statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||1.378|0.752|=0.9218
72624012|NCT02231580|144778425|SUPERIORITY_OR_OTHER||GLS mean ratio|0.847|||=|0.5032|TWO_SIDED|90.0|0.561|1.277|||MMRM|||Right hand duration of TD statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||1.277|0.561|=0.5032
72624013|NCT02231580|144778426|SUPERIORITY_OR_OTHER||GLS mean ratio|1.14|||=|0.6759|TWO_SIDED|90.0|0.677|1.917|||MMRM|||Left hand IPI variability statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||1.917|0.677|=0.6759
72624014|NCT02231580|144778426|SUPERIORITY_OR_OTHER||GLS mean ratio|0.815|||=|0.5764|TWO_SIDED|90.0|0.444|1.496|||MMRM|||Right hand IPI variability statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||1.496|0.444|=0.5764
72510621|NCT05151471|144551536|SUPERIORITY|||||||0.704|||||||ANCOVA|||Week 72||||0.704
72510622|NCT05151471|144551536|SUPERIORITY|||||||0.131|||||||ANCOVA|||Week 96||||0.131
72510623|NCT05151471|144551537|SUPERIORITY|||||||0.954|||||||Mixed Model for Repeated Measures (MMRM)|||Week 72||||0.954
72624015|NCT02231580|144778426|SUPERIORITY_OR_OTHER||GLS mean ratio|1.115|||=|0.2127|TWO_SIDED|90.0|0.965|1.289|||MMRM|||Left hand IPI duration statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||1.289|0.965|=0.2127
72624016|NCT02231580|144778426|SUPERIORITY_OR_OTHER||GLS mean ratio|1.059|||=|0.5661|TWO_SIDED|90.0|0.897|1.25|||MMRM|||Right hand IPI duration statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||1.25|0.897|=0.5661
72566883|NCT02312713|144664447|NON_INFERIORITY|Since there were not sufficient data in prior literature to specific an a priori non-inferiority margin, for this and other secondary outcomes we based conclusions and discussions on magnitude of differences between the group, descriptively. This strategy was specified in the protocol.|Mean Difference (Final Values)|0.14||||0.81|TWO_SIDED|95.0|-1.03|1.31|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Internet Based Exercise Training at 12 months for Strength.||1.31|-1.03|0.81
72566884|NCT02312713|144664447|SUPERIORITY||Mean Difference (Final Values)|1.85||||0|TWO_SIDED|95.0|0.67|3.03|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Wait List Control at 4 months for Stretching.||3.03|0.67|0.00
72482067|NCT00475033|144491703|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower limit of the 2-sided 95% CI for the difference between the 2 treatment groups was \> -10%.|Difference|1.1|||||TWO_SIDED|95.0|-1.7|4.2|||||Exact 2-sided CI for the difference in proportions (13vPnC, 7vPnC) expressed as a percentage.|PRN: Difference in proportions (13vPnC, 7vPnC) expressed as a percentage.||4.2|-1.7|
72482068|NCT00475033|144491703|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower limit of the 2-sided 95% CI for the difference between the 2 treatment groups was \> -10%.|Difference|-2.1|||||TWO_SIDED|95.0|-5.5|1.2|||||Exact 2-sided CI for the difference in proportions (13vPnC, 7vPnC) expressed as a percentage.|FIM: Difference in proportions (13vPnC, 7vPnC) expressed as a percentage||1.2|-5.5|
72482069|NCT00475033|144491704|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower limit of the 2-sided 95% CI for the difference between the 2 treatment groups was \> -10%.|Difference|0.0|||||TWO_SIDED|95.0|-1.4|1.4|||||Exact 2-sided CI for the difference in proportions (13vPnC, 7vPnC) expressed as a percentage.|Meningococcal C: Difference in proportions (13vPnC, 7vPnC) expressed as a percentage.||1.4|-1.4|
72482070|NCT00475033|144491705|SUPERIORITY_OR_OTHER||Ratio of geometric means|1.27|||||TWO_SIDED|95.0|1.08|1.5|||||CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).|Meningococcal C: Ratio of geometric means (13vPnC, 7vPnC)||1.50|1.08|
72482071|NCT00475033|144491710|SUPERIORITY_OR_OTHER||Ratio of geometric means|1.14|||||TWO_SIDED|95.0|1.02|1.27|||||CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).|PT: Ratio of geometric means (13vPnC, 7vPnC)||1.27|1.02|
72482072|NCT00475033|144491710|SUPERIORITY_OR_OTHER||Ratio of geometric means|1.12|||||TWO_SIDED|95.0|1.01|1.25|||||CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).|FHA: Ratio of geometric means (13vPnC, 7vPnC)||1.25|1.01|
72482073|NCT00475033|144491710|SUPERIORITY_OR_OTHER||Ratio of geometric means|1.05|||||TWO_SIDED|95.0|0.89|1.24|||||CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).|PRN: Ratio of geometric means (13vPnC, 7vPnC)||1.24|0.89|
72482074|NCT00475033|144491710|SUPERIORITY_OR_OTHER||Ratio of geometric means|0.89|||||TWO_SIDED|95.0|0.78|1.02|||||CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).|FIM: Ratio of geometric means (13vPnC, 7vPnC)||1.02|0.78|
72482075|NCT00475033|144491711|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower limit of the 2-sided 95% CI for the difference between the 2 treatment groups was \> -10%.|Difference|-1.8|||||TWO_SIDED|95.0|-4.4|0.1|||||Exact 2-sided CI for the difference in proportions (13vPnC, 7vPnC) expressed as a percentage.|Difference in proportions (13vPnC, 7vPnC) expressed as a percentage.||0.1|-4.4|
72482076|NCT00475033|144491712|SUPERIORITY_OR_OTHER||Ratio of geometric means|0.91|||||TWO_SIDED|95.0|0.75|1.12|||||CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).|PRP in Hib: Ratio of geometric means (13vPnC, 7vPnC)||1.12|0.75|
72482077|NCT00475033|144491713|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower limit of the 2-sided 95% CI for the difference between the 2 treatment groups was \> -10%.|Difference|-3.0|||||TWO_SIDED|95.0|-9.4|3.4|||||Exact 2-sided CI for the difference in proportions (13vPnC, 7vPnC) expressed as a percentage.|PRP: Difference in proportions (13vPnC, 7vPnC) expressed as a percentage.||3.4|-9.4|
72510624|NCT05151471|144551537|SUPERIORITY|||||||0.591|||||||Mixed Model for Repeated Measures (MMRM)|||Week 96||||0.591
72510625|NCT05151471|144551538|SUPERIORITY|||||||0.513|||||||Mixed Model for Repeated Measures (MMRM)|||Week 72||||0.513
72510626|NCT05151471|144551538|SUPERIORITY|||||||0.344|||||||Mixed Model for Repeated Measures (MMRM)|||Week 84||||0.344
72510627|NCT05151471|144551538|SUPERIORITY|||||||0.142|||||||Mixed Model for Repeated Measures (MMRM)|||Week 96||||0.142
72510628|NCT04263142|144551542|OTHER||Ratio|0.998|||||TWO_SIDED|90.0|0.9263|1.0757|||||Analysis was performed using analysis of variance (ANOVA) with treatment, period, and sequence as fixed effects and participant as a random effect on the natural log-transformed parameter AUC(0-inf). Ratio of GSK3640254 200 mg tablets/capsules.|||1.0757|0.9263|
72510629|NCT04263142|144551543|OTHER||Ratio|1.002|||||TWO_SIDED|90.0|0.9321|1.0781|||||Analysis was performed using ANOVA with treatment, period, and sequence as fixed effects and participant as a random effect on the natural log-transformed parameter AUC(0-t). Ratio of GSK3640254 200 mg tablets/capsules.|||1.0781|0.9321|
72510630|NCT04263142|144551544|OTHER||Ratio|1.093|||||TWO_SIDED|90.0|0.9885|1.208|||||Analysis was performed using ANOVA with treatment, period, and sequence as fixed effects and participant as a random effect on the natural log-transformed parameter Cmax. Ratio of GSK3640254 200 mg tablets/capsules.|||1.2080|0.9885|
72510631|NCT04263142|144551546|OTHER||Ratio|2.926|||||TWO_SIDED|90.0|2.3703|3.6107|||||Analysis was performed using ANOVA with treatment, period, and sequence as fixed effects and participant as a random effect on the natural log-transformed parameter AUC(0-inf). Ratio of GSK3640254 200 mg tablet (moderate fat)/(fasted)|||3.6107|2.3703|
72510632|NCT04263142|144551546|OTHER||Ratio|2.594|||||TWO_SIDED|90.0|2.1003|3.2038|||||Analysis was performed using ANOVA with treatment, period, and sequence as fixed effects and participant as a random effect on the natural log-transformed parameter AUC(0-inf). Ratio of GSK3640254 200 mg tablet (high fat)/(fasted)|||3.2038|2.1003|
72510633|NCT04263142|144551547|OTHER||Ratio|3.146|||||TWO_SIDED|90.0|2.5925|3.8178|||||Analysis was performed using ANOVA with treatment, period, and sequence as fixed effects and participant as a random effect on the natural log-transformed parameter AUC(0-t). Ratio of GSK3640254 200 mg tablet (moderate fat)/(fasted)|||3.8178|2.5925|
72510634|NCT04263142|144551547|OTHER||Ratio|2.785|||||TWO_SIDED|90.0|2.2943|3.3807|||||Analysis was performed using ANOVA with treatment, period, and sequence as fixed effects and participant as a random effect on the natural log-transformed parameter AUC(0-t). Ratio of GSK3640254 200 mg tablet (high fat)/(fasted)|||3.3807|2.2943|
72510635|NCT04263142|144551548|OTHER||Ratio|4.101|||||TWO_SIDED|90.0|3.2442|5.183|||||Analysis was performed using ANOVA with treatment, period, and sequence as fixed effects and participant as a random effect on the natural log-transformed parameter Cmax. Ratio of GSK3640254 200 mg tablet (moderate fat)/(fasted)|||5.1830|3.2442|
72510636|NCT04263142|144551548|OTHER||Ratio|3.08|||||TWO_SIDED|90.0|2.4359|3.8935|||||Analysis was performed using ANOVA with treatment, period, and sequence as fixed effects and participant as a random effect on the natural log-transformed parameter Cmax. Ratio of GSK3640254 200 mg tablet (high fat)/(fasted)|||3.8935|2.4359|
72510637|NCT00316303|144551652|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wald Chi-squared|||||||<0.001
72510638|NCT00316303|144551653|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wald Chi-squared|||||||<0.001
72510639|NCT00316303|144551654|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wald Chi-squared|||||||<0.001
72510640|NCT00316303|144551655|SUPERIORITY_OR_OTHER|||||||0.011|||||||Wald Chi-squared|||||||0.011
72510641|NCT00316303|144551656|SUPERIORITY_OR_OTHER|||||||0.6|||||||Chi-squared|||||||0.6
72510642|NCT00850759|144551657|SUPERIORITY_OR_OTHER||Slope|0.04|||<|0.05|TWO_SIDED|95.0|||||ANOVA|||||||<0.05
72566885|NCT02312713|144664447|SUPERIORITY||Mean Difference (Final Values)|1.62||||0|TWO_SIDED|95.0|0.55|2.68|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Wait List Control at 12 months for Stretching.||2.68|0.55|0.00
72510643|NCT01753076|144551667|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-30.0||||0.12|TWO_SIDED|95.0|-67.9|7.9|||ANCOVA||A negative mean difference means that the direction of effect is in favor of placebo.|||7.9|-67.9|0.120
72510644|NCT01753076|144551668|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.3||||0.139|TWO_SIDED|95.0|-3.1|0.4|||Mixed Models Analysis|||||0.4|-3.1|0.139
72510645|NCT01753076|144551669|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.12||||0.173|TWO_SIDED|95.0|-0.3|0.05|||Random coefficients analysis|||||0.05|-0.30|0.173
72510646|NCT01753076|144551670|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.127||||0.265|TWO_SIDED|95.0|-0.351|0.097|||Mixed Models Analysis|||||0.097|-0.351|0.265
72510647|NCT01753076|144551671|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.2||||0.125|TWO_SIDED|95.0|-18.7|2.3|||Mixed Models Analysis|||||2.3|-18.7|0.125
72510648|NCT01753076|144551672|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.73||||0.393|TWO_SIDED|95.0|0.36|1.49|||Regression, Logistic|||||1.49|0.36|0.393
72510649|NCT01753076|144551673|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.99||||0.986|TWO_SIDED|95.0|0.34|2.89|||Regression, Cox||Week 48|||2.89|0.34|0.986
72510650|NCT01753076|144551673|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.03||||0.923|TWO_SIDED|95.0|0.53|2.01|||Chi-squared||Week 60|||2.01|0.53|0.923
72566886|NCT02312713|144664447|SUPERIORITY||Mean Difference (Final Values)|1.37||||0.03|TWO_SIDED|95.0|0.16|2.57|||Mixed Models Analysis|||This is the comparison between Internet Based Exercise Training and Wait List Control at 4 months for Stretching.||2.57|0.16|0.03
72510651|NCT01753076|144551674|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.07||||0.642|TWO_SIDED|95.0|0.81|1.42|||Regression, Cox|||||1.42|0.81|0.642
72566887|NCT02312713|144664447|SUPERIORITY||Mean Difference (Final Values)|2.07||||0|TWO_SIDED|95.0|0.98|3.16|||Mixed Models Analysis|||This is the comparison between Internet Based Exercise Training and Wait List Control at 12 months for Stretching.||3.16|0.98|0.00
72510652|NCT01753076|144551675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.004|||||TWO_SIDED|95.0|-0.062|0.053||||||||0.053|-0.062|
72510653|NCT01753076|144551676|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.4|||||TWO_SIDED|95.0|-2.8|5.5||||||||5.5|-2.8|
72510654|NCT00300469|144551703|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||alpha = 0.05, all 3 primary endpoints had to show superiority of combo therapy in order to declare combo therapy successful at a given statin dose, Hochberg method for multiple comparison adjustment for 2 statin doses|ANCOVA|||An n = 92 per arm would provide \>99% power to detect a 20% decrease in triglycerides relative to statin monotherapy for each combo therapy dose, assuming an SD of 30%||||<0.001
72510655|NCT00300469|144551703|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||alpha = 0.05, all 3 primary endpoints had to show superiority of combo therapy in order to declare combo therapy successful at a given statin dose, Hochberg method for multiple comparison adjustment for 2 statin doses|ANCOVA|||An n = 92 per arm would provide \>99% power to detect a 20% decrease in triglycerides relative to statin monotherapy for each combo therapy dose, assuming an SD of 30%||||<0.001
72510656|NCT00300469|144551704|SUPERIORITY_OR_OTHER|||||||0.005||95.0||||alpha = 0.05, all 3 primary endpoints had to show superiority of combo therapy in order to declare combo therapy successful at a given statin dose, Hochberg method for multiple comparison adjustment for 2 statin doses|ANCOVA|||An n = 92 per arm would provide 99% power to detect a 13% increase in HDL-C relative to statin monotherapy for each combo therapy dose, assuming an SD of 15%||||0.005
72510657|NCT00300469|144551704|SUPERIORITY_OR_OTHER|||||||0.01||95.0||||alpha = 0.05, all 3 primary endpoints had to show superiority of combo therapy in order to declare combo therapy successful at a given statin dose, Hochberg method for multiple comparison adjustment for 2 statin doses|ANCOVA|||An n = 92 per arm would provide 99% power to detect a 13% increase in HDL-C relative to statin monotherapy for each combo therapy dose, assuming an SD of 15%||||0.010
72510658|NCT00300469|144551705|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||alpha = 0.05, all 3 primary endpoints had to show superiority of combo therapy in order to declare combo therapy successful at a given statin dose, Hochberg method for multiple comparison adjustment for 2 statin doses|ANCOVA|||An n = 92 per arm would provide \>99% power to detect a 31% decrease in LDL-C relative to ABT-335 monotherapy for each combo therapy dose, assuming an SD of 15%||||<0.001
72510659|NCT00300469|144551705|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||alpha = 0.05, all 3 primary endpoints had to show superiority of combo therapy in order to declare combo therapy successful at a given statin dose, Hochberg method for multiple comparison adjustment for 2 statin doses|ANCOVA|||An n = 92 per arm would provide \>99% power to detect a 31% decrease in LDL-C relative to ABT-335 monotherapy for each combo therapy dose, assuming an SD of 15%||||<0.001
72510660|NCT00578864|144551723|SUPERIORITY_OR_OTHER_LEGACY|||||||0.367||95.0|||||Fisher Exact|||||||0.367
72510661|NCT00578864|144551726|SUPERIORITY_OR_OTHER_LEGACY|||||||0.592||95.0|||||Fisher Exact|||||||0.592
72510662|NCT01253044|144551768|SUPERIORITY_OR_OTHER|||||||0.912|TWO_SIDED||||||MMRM|||||||.912
72510663|NCT01253044|144551769|SUPERIORITY_OR_OTHER|||||||0.273|TWO_SIDED||||||MMRM|||||||.273
72510664|NCT04490265|144551783|SUPERIORITY||Cohen's d|0.33|||||TWO_SIDED|||||||||||||
72510665|NCT04490265|144551784|SUPERIORITY||Cohen's d|0.78|||||TWO_SIDED|||||||||||||
72510666|NCT04490265|144551789|SUPERIORITY||Cohen's d|0.14|||||TWO_SIDED|||||||||Belonging Subscale change from baseline to 12-weeks||||
72510667|NCT04490265|144551789|SUPERIORITY||Cohen's D|0.05|||||TWO_SIDED|||||||||Belonging subscale Baseline to 6-months||||
72510668|NCT04490265|144551789|SUPERIORITY||Cohen's D|0.6|||||TWO_SIDED|||||||||Change in Burdensome subscale Baseline to 12-weeks||||
72510669|NCT04490265|144551789|SUPERIORITY||Cohen's D|0.43|||||TWO_SIDED|||||||||Change in Burdensome subscale Baseline to 6 months||||
72510670|NCT04490265|144551790|SUPERIORITY||Cohen's D|0.07|||||TWO_SIDED|||||||||Baseline to 12-weeks||||
72510671|NCT04490265|144551790|SUPERIORITY||Cohen's D|0.13|||||TWO_SIDED|||||||||Baseline to 6-months||||
72510672|NCT04490265|144551791|SUPERIORITY||Cohen's d|0.6|||||TWO_SIDED|||||||||||||
72510673|NCT04490265|144551792|SUPERIORITY||Cohen's d|0.52|||||TWO_SIDED|||||||||||||
72510674|NCT04490265|144551793|SUPERIORITY||Cohen's d|0.21|||||TWO_SIDED|||||||||||||
72510675|NCT04490265|144551794|SUPERIORITY||Cohen's d|0.2|||||TWO_SIDED|||||||||||||
72510676|NCT04490265|144551795|SUPERIORITY||Cohen's d|0.66|||||TWO_SIDED|||||||||||||
72510677|NCT04490265|144551796|SUPERIORITY||cohen's d|0.38|||||TWO_SIDED|||||||||||||
72510678|NCT04490265|144551797|SUPERIORITY||Cohens d|0.47|||||TWO_SIDED|||||||||Severity||||
72510679|NCT04490265|144551797|SUPERIORITY||Cohens d|0.46|||||TWO_SIDED|||||||||interference||||
72510680|NCT04490265|144551798|SUPERIORITY||Cohens d|0.64|||||TWO_SIDED|||||||||Severity Subscale||||
72510681|NCT04490265|144551798|SUPERIORITY||Cohen's d|0.38|||||TWO_SIDED|||||||||Interference subscale||||
72510682|NCT00962000|144551799|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The sample size required for the study was estimated using a web-based power calculation tool. Analysis of data from some 50,000 hemodialysis patients showed a within-patient between-treatment standard deviation of 0.21 for Kt/Vurea. Using this estimate of standard deviation, 38 subjects would be needed to detect a difference in Kt/Vurea of 0.1 with a significance level of 0.05 and a power of 90% with two determinations per subject at each level of dialysate flow rate.|Mean Difference (Final Values)|-0.024|STANDARD_ERROR_OF_MEAN|0.02217|||TWO_SIDED|95.0|-0.064|0.024||There is no p values because the power calculation is based on the primary outcome variable|ANOVA|The three centers and the two flow rates were treated as fixed effects and the subjects within centers modeled as a random effect.||Increasing the dialysate flow rates from 600 mL/min to 800 mL/min will not significantly increase Kt/Vurea.||0.024|-0.064|
72510683|NCT00962000|144551800|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The sample size required for the study was estimated using a web-based power calculation tool. Analysis of data from some 50,000 hemodialysis patients showed a within-patient between-treatment standard deviation of 0.21 for Kt/Vurea. Using this estimate of standard deviation, 38 subjects would be needed to detect a difference in Kt/Vurea of 0.1 with a significance level of 0.05 and a power of 90% with two determinations per subject at each level of dialysate flow rate.|Mean Difference (Final Values)|-0.014|STANDARD_ERROR_OF_MEAN|0.01849|||TWO_SIDED|95.0|-0.051|0.023||There is no p value for eKt/V because the power calculation is based on the primary outcome variable (Kt/Vsp) alone.|ANOVA|The three centers and the two flow rates were treated as fixed effects and the subjects within centers modeled as a random effect.||Increasing the dialysate flow rates from 600 mL/min to 800 mL/min will not significantly increase Kt/Vurea.||0.023|-0.051|
72510684|NCT00962000|144551801|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The sample size required for the study was estimated using a web-based power calculation tool. Analysis of data from some 50,000 hemodialysis patients showed a within-patient between-treatment standard deviation of 0.21 for Kt/Vurea. Using this estimate of standard deviation, 38 subjects would be needed to detect a difference in Kt/Vurea of 0.1 with a significance level of 0.05 and a power of 90% with two determinations per subject at each level of dialysate flow rate.|Mean Difference (Final Values)|0.035|STANDARD_ERROR_OF_MEAN|0.03103||||95.0|-0.029|0.099||There is no p value for Kt/VID because the power calculation is based on the primary outcome variable (Kt/Vsp) alone.|ANOVA|||Increasing the dialysate flow rates from 600 mL/min to 800 mL/min will not significantly increase Kt/Vurea.||0.099|-0.029|
72510685|NCT02702193|144551802|SUPERIORITY||Slope|-0.24|STANDARD_ERROR_OF_MEAN|0.11|<|0.05|TWO_SIDED|95.0|||||Generalized Estimating Equations (GEE)|GEE allowed the examination of trajectories from baseline through the 12 month follow-up.||To determine sample size for the grant proposal we conducted simulation studies in Mplus (Muthén \& Muthén, 2010) following the procedure described by Muthén and Muthén (2002). Each simulation created 10,000 datasets, assuming a medium-size (d = .5) intervention effect, and attrition of 10% at each assessment. For α= .05, the power estimate was at or above 80% with a sample of 172 mothers.||||<.05
72510686|NCT01201798|144551813|NON_INFERIORITY_OR_EQUIVALENCE|The noninferiority margin was 0.5 units, meaning that the upper limit of the two-tailed 95% confidence interval must have been less than 0.5 to establish noninferiority.|Mean Difference (Net)|-0.22|||||TWO_SIDED|95.0|-0.53|0.09|||ANCOVA|||A two-tailed 95% confidence interval was calculated for the difference in change from baseline in anterior chamber cell grade at Day 14 (difluprednate minus prednisolone). The confidence interval was derived from an analysis of covariance (ANCOVA), with investigative site included as a fixed effect to match the stratification used in the randomization process. Treatment and baseline anterior chamber cell grade were also included as fixed effects.||0.09|-0.53|
72510687|NCT02538666|144551898|SUPERIORITY||Hazard Ratio (HR)|0.92||||0.3693|TWO_SIDED|95.0|0.75|1.12|||Stratified Log Rank|Stratified by response to ECOG PS (0vs1), gender (MvF), irradiation following chemotherapy (YorN) as entered in IVRS|based on stratified 3-arms Cox proportional hazard model|nivolumab + ipilimumab over placebo||1.12|0.75|0.3693
72510688|NCT02538666|144551899|SUPERIORITY||Hazard Ratio (HR)|0.81|||||TWO_SIDED|95.0|0.68|0.97|||||Hazard Ratios are based on stratified 3-arms Cox proportional hazard model.|Global nivolumab over global placebo||0.97|0.68|
72510689|NCT02538666|144551899|SUPERIORITY||Hazard Ratio (HR)|0.93|||||TWO_SIDED|95.0|0.53|1.66|||||Hazard Ratios are based on unstratified 3-arms Cox proportional hazard model.|China nivolumab over China Placebo||1.66|0.53|
72510690|NCT02538666|144551900|SUPERIORITY||Hazard Ratio (HR)|1.13|||||TWO_SIDED|95.0|0.94|1.36|||||Hazard Ratios are based on stratified 3-arms Cox proportional hazard model.|Global nivolumab + ipilimumab over global nivolumab||1.36|0.94|
72510691|NCT02538666|144551900|SUPERIORITY||Hazard Ratio (HR)|1.0|||||TWO_SIDED|95.0|0.56|1.79|||||Hazard Ratios are based on unstratified 3-arms Cox proportional hazard model.|China nivolumab + ipilimumab over China nivolumab||1.79|0.56|
72510692|NCT02538666|144551901|SUPERIORITY||Hazard Ratio (HR)|0.74|||||TWO_SIDED|95.0|0.62|0.88|||||Hazard Ratios are based on stratified 3-arms Cox proportional hazard model.|Global nivolumab + ipilimumab over global placebo||0.88|0.62|
72510693|NCT02538666|144551901|SUPERIORITY||Hazard Ratio (HR)|0.66|||||TWO_SIDED|95.0|0.55|0.79|||||Hazard Ratios are based on stratified 3-arms Cox proportional hazard model.|Global nivolumab over global placebo||0.79|0.55|
72510694|NCT02538666|144551901|SUPERIORITY||Hazard Ratio (HR)|1.13|||||TWO_SIDED|95.0|0.94|1.35|||||Hazard Ratios are based on stratified 3-arms Cox proportional hazard model.|Global nivolumab+ ipilimumab over nivolumab||1.35|0.94|
72566888|NCT02312713|144664447|NON_INFERIORITY|Since there were not sufficient data in prior literature to specific an a priori non-inferiority margin, for this and other secondary outcomes we based conclusions and discussions on magnitude of differences between the group, descriptively. This strategy was specified in the protocol.|Mean Difference (Final Values)|-0.48||||0.33|TWO_SIDED|95.0|-1.46|0.5|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Internet Based Exercise Training at 4 months for Stretching.||0.5|-1.46|0.33
72510695|NCT02538666|144551901|SUPERIORITY||Hazard Ratio (HR)|0.61|||||TWO_SIDED|95.0|0.33|1.12|||||Hazard Ratios are based on unstratified 3-arms Cox proportional hazard model.|China Nivolumab + Ipilimumab over China placebo||1.12|0.33|
72402007|NCT02515942|144311354|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|0.44||||0.4149|TWO_SIDED|80.0|-2.18|3.06|||Mixed Models Analysis|||Change from baseline at Day 57||3.06|-2.18|0.4149
72510696|NCT02538666|144551901|SUPERIORITY||Hazard Ratio (HR)|0.45|||||TWO_SIDED|95.0|0.24|0.85|||||Hazard Ratios are based on unstratified 3-arms Cox proportional hazard model.|China Nivolumab over China placebo||0.85|0.24|
72566889|NCT02312713|144664447|NON_INFERIORITY|Since there were not sufficient data in prior literature to specific an a priori non-inferiority margin, for this and other secondary outcomes we based conclusions and discussions on magnitude of differences between the group, descriptively. This strategy was specified in the protocol.|Mean Difference (Final Values)|0.45||||0.32|TWO_SIDED|95.0|-0.44|1.34|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Internet Based Exercise Training at 12 months for Stretching.||1.34|-0.44|0.32
72566890|NCT02312713|144664447|SUPERIORITY||Mean Difference (Final Values)|1.09||||0.21|TWO_SIDED|95.0|-0.61|2.8|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Wait List Control at 4 months for Aerobic Exercise.||2.8|-0.61|0.21
72510697|NCT02538666|144551901|SUPERIORITY||Hazard Ratio (HR)|1.34|||||TWO_SIDED|95.0|0.72|2.49|||||Hazard Ratios are based on unstratified 3-arms Cox proportional hazard model.|China Nivolumab + Ipilimumab over China Nivolumab||2.49|0.72|
72510698|NCT02538666|144551902|SUPERIORITY||Hazard Ratio (HR)|0.84|||||TWO_SIDED|95.0|0.61|1.15|||||Unstratified Cox proportional hazard model. Hazard Ratios are experimental treatment group over placebo.|TMB cutoff ≥10 mutations/mb: Nivo+Ipi over placebo||1.15|0.61|
72566891|NCT02312713|144664447|SUPERIORITY||Mean Difference (Final Values)|2.07||||0.04|TWO_SIDED|95.0|0.13|4.0|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Wait List Control at 12 months for Aerobic Exercise.||4|0.13|0.04
72566892|NCT02312713|144664447|SUPERIORITY||Mean Difference (Final Values)|1.89||||0.03|TWO_SIDED|95.0|0.15|3.62|||Mixed Models Analysis|||This is the comparison between Internet Based Exercise Training and Wait List Control at 4 months for Aerobic Exercise.||3.62|0.15|0.03
72510699|NCT02538666|144551902|SUPERIORITY||Hazard Ratio (HR)|0.76|||||TWO_SIDED|95.0|0.55|1.04|||||Unstratified Cox proportional hazard model. Hazard Ratios are experimental treatment group over placebo.|TMB cutoff ≥10 mutations/mb: Nivo over placebo||1.04|0.55|
72510700|NCT02538666|144551902|SUPERIORITY||Hazard Ratio (HR)|0.62|||||TWO_SIDED|95.0|0.42|0.92|||||Unstratified Cox proportional hazard model. Hazard Ratios are experimental treatment group over placebo.|TMB cutoff ≥13 mutations/mb: Nivo+Ipi over placebo||0.92|0.42|
72510701|NCT02538666|144551902|SUPERIORITY||Hazard Ratio (HR)|0.64|||||TWO_SIDED|95.0|0.44|0.93|||||Unstratified Cox proportional hazard model. Hazard Ratios are experimental treatment group over placebo.|TMB cutoff ≥13 mutations/mb: Nivo over placebo||0.93|0.44|
72510702|NCT02538666|144551902|SUPERIORITY||Hazard Ratio (HR)|0.9|||||TWO_SIDED|95.0|0.68|1.21|||||Unstratified Cox proportional hazard model. Hazard Ratios are experimental treatment group over placebo.|TMB cutoff \<10 mutations/mb: Nivo+Ipi over placebo||1.21|0.68|
72510703|NCT02538666|144551902|SUPERIORITY||Hazard Ratio (HR)|0.88|||||TWO_SIDED|95.0|0.66|1.18|||||Unstratified Cox proportional hazard model. Hazard Ratios are experimental treatment group over placebo.|TMB cutoff \<10 mutations/mb: Nivo over placebo||1.18|0.66|
72510704|NCT02538666|144551902|SUPERIORITY||Hazard Ratio (HR)|1.05|||||TWO_SIDED|95.0|0.81|1.35|||||Unstratified Cox proportional hazard model. Hazard Ratios are experimental treatment group over placebo.|TMB cutoff \<13 mutations/mb: Nivo+Ipi over placebo||1.35|0.81|
72510705|NCT02538666|144551902|SUPERIORITY||Hazard Ratio (HR)|0.93|||||TWO_SIDED|95.0|0.72|1.2|||||Unstratified Cox proportional hazard model. Hazard Ratios are experimental treatment group over placebo.|TMB cutoff \<13 mutations/mb: Nivo over placebo||1.20|0.72|
72510706|NCT02538666|144551903|SUPERIORITY||Hazard Ratio (HR)|0.8|||||TWO_SIDED|95.0|0.58|1.09|||||Unstratified Cox proportional hazard model. Hazard Ratios are experimental treatment group over placebo.|TMB cutoff ≥10 mutations/mb: Nivo+Ipi over placebo||1.09|0.58|
72510707|NCT02538666|144551903|SUPERIORITY||Hazard Ratio (HR)|0.68|||||TWO_SIDED|95.0|0.5|0.92|||||Unstratified Cox proportional hazard model. Hazard Ratios are experimental treatment group over placebo.|TMB cutoff ≥10 mutations/mb: Nivo over placebo||0.92|0.50|
72510708|NCT02538666|144551903|SUPERIORITY||Hazard Ratio (HR)|0.73|||||TWO_SIDED|95.0|0.5|1.07|||||Unstratified Cox proportional hazard model. Hazard Ratios are experimental treatment group over placebo.|TMB cutoff ≥13 mutations/mb: Nivo+Ipi over placebo||1.07|0.50|
72510709|NCT02538666|144551903|SUPERIORITY||Hazard Ratio (HR)|0.66|||||TWO_SIDED|95.0|0.46|0.95|||||Unstratified Cox proportional hazard model. Hazard Ratios are experimental treatment group over placebo.|TMB cutoff ≥13 mutations/mb: Nivo over placebo||0.95|0.46|
72510710|NCT02538666|144551903|SUPERIORITY||Hazard Ratio (HR)|0.72|||||TWO_SIDED|95.0|0.54|0.96|||||Unstratified Cox proportional hazard model. Hazard Ratios are experimental treatment group over placebo.|TMB cutoff \<10 mutations/mb: Nivo+Ipi over placebo||0.96|0.54|
72510711|NCT02538666|144551903|SUPERIORITY||Hazard Ratio (HR)|0.66|||||TWO_SIDED|95.0|0.49|0.89|||||Unstratified Cox proportional hazard model. Hazard Ratios are experimental treatment group over placebo.|TMB cutoff \<10 mutations/mb: Nivo over placebo||0.89|0.49|
72510712|NCT02538666|144551903|SUPERIORITY||Hazard Ratio (HR)|0.78|||||TWO_SIDED|95.0|0.6|1.01|||||Unstratified Cox proportional hazard model. Hazard Ratios are experimental treatment group over placebo.|TMB cutoff \<13 mutations/mb: Nivo+Ipi over placebo||1.01|0.60|
72510713|NCT02538666|144551903|SUPERIORITY||Hazard Ratio (HR)|0.68|||||TWO_SIDED|95.0|0.53|0.89|||||Unstratified Cox proportional hazard model. Hazard Ratios are experimental treatment group over placebo.|TMB cutoff \<13 mutations/mb: Nivo over placebo||0.89|0.53|
72510714|NCT02538666|144551904|SUPERIORITY||Hazard Ratio (HR)|0.91|||||TWO_SIDED|95.0|0.76|1.09|||Stratified Log Rank||Hazard Ratios are based on stratified 3-arms Cox proportional hazard model.|Global nivolumab + ipilimumab over Global placebo||1.09|0.76|
72510715|NCT02538666|144551904|SUPERIORITY||Hazard Ratio (HR)|0.94|||||TWO_SIDED|95.0|0.52|1.67|||Stratified Log Rank||Hazard Ratios are based on unstratified 3-arms Cox proportional hazard model.|China nivolumab + ipilimumab over China placebo||1.67|0.52|
72510716|NCT03345836|144551905|SUPERIORITY||Adjusted Risk Difference|17.9|||<|0.0001|TWO_SIDED|95.0|10.0|25.8||P-value was calculated using Cochran-Mantel Haenszel (CMH) test adjusted for randomization stratification factors.|Cochran-Mantel-Haenszel||Point estimate and 95% confidence interval (CI) were calculated using CMH risk difference estimate.|||25.8|10.0|<0.0001
72510717|NCT03345836|144551906|SUPERIORITY||Adjusted Risk Difference|31.2|||<|0.0001|TWO_SIDED|95.0|25.5|37.0||P-value was calculated using CMH test adjusted for randomization stratification factors.|Cochran-Mantel-Haenszel||Point estimate and 95% CI was calculated using CMH risk difference estimate.|||37.0|25.5|<0.0001
72510718|NCT03345836|144551908|SUPERIORITY||Adjusted Treatment Difference|25.9|||<|0.0001|TWO_SIDED|95.0|18.7|33.1||P-value was calculated using CMH test adjusted for randomization stratification factors.|Cochran-Mantel-Haenszel||Point estimate and 95% CI was calculated using CMH.|||33.1|18.7|<0.0001
72510719|NCT03345836|144551909|SUPERIORITY||Adjusted Treatment Difference|16.8|||<|0.0001|TWO_SIDED|95.0|12.0|21.6||P-value was calculated using CMH test adjusted for randomization stratification factors.|Cochran-Mantel-Haenszel||Point estimate and 95% CI was calculated using CMH.|||21.6|12.0|<0.0001
72510720|NCT03345836|144551910|SUPERIORITY||Adjusted Treatment Difference|22.5||||0.0001|TWO_SIDED|95.0|11.1|34.0||P-value was calculated using CMH test adjusted for randomization stratification factors.|Cochran-Mantel-Haenszel||Point estimate and 95% CI was calculated using CMH.|||34.0|11.1|0.0001
72510721|NCT03345836|144551911|SUPERIORITY||Adjusted Treatment Difference|7.5|||<|0.0001|TWO_SIDED|95.0|5.2|9.8||P-value was calculated using mixed effect model repeat measurement (MMRM) with Baseline, treatment, visit, treatment by visit interaction and stratification factors in the model.|MMRM||Point estimate and 95% CI was calculated using MMRM.|||9.8|5.2|< 0.0001
72510722|NCT03345836|144551912|SUPERIORITY||Adjusted Treatment Difference|24.3|||<|0.0001|TWO_SIDED|95.0|17.2|31.5||P-value was calculated using MMRM with Baseline, treatment, visit, treatment by visit interaction and stratification factors in the model.|MMRM||Point estimate and 95% CI was calculated using MMRM.|||31.5|17.2|< 0.0001
72510723|NCT03345836|144551913|SUPERIORITY||Adjusted Treatment Difference|20.7|||<|0.0001|TWO_SIDED|95.0|13.7|27.8||P-value was calculated using CMH test adjusted for randomization stratification factors.|Cochran-Mantel-Haenszel||Point estimate and 95% CI was calculated using CMH.|||27.8|13.7|<0.0001
72510724|NCT03345836|144551914|SUPERIORITY||Adjusted Treatment Difference|22.8|||<|0.0001|TWO_SIDED|95.0|14.4|31.2||P-value was calculated using CMH test adjusted for randomization stratification factors.|Cochran-Mantel-Haenszel||Point estimate and 95% CI was calculated using CMH.|||31.2|14.4|<0.0001
72510725|NCT03345836|144551915|SUPERIORITY||Adjusted Treatment Difference|12.1||||0.0013|TWO_SIDED|95.0|4.7|19.5||P-value was calculated using CMH test adjusted for randomization stratification factors.|Cochran-Mantel-Haenszel||Point estimate and 95% CI was calculated using CMH.|||19.5|4.7|0.0013
72510726|NCT03345836|144551916|SUPERIORITY||Treatment Difference|-2.6||||0.2834|TWO_SIDED|95.0|-7.6|2.4||P-value was calculated using Chi-squared test.|Chi-squared||Point estimate and 95% CI was calculated using Chi-squared test.|||2.4|-7.6|0.2834
72510727|NCT03345836|144551917|SUPERIORITY||Adjusted Treatment Difference|11.5||||0.0833|TWO_SIDED|95.0|-1.5|24.4||P-value was calculated using CMH test adjusted for randomization stratification factors.|Cochran-Mantel-Haenszel||Point estimate and 95% CI was calculated using CMH.|||24.4|-1.5|0.0833
72510728|NCT00829166|144551919|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.65|||<|0.0001|TWO_SIDED|95.0|0.549|0.771|||Log Rank||HR (relative to Lapatinib + Capecitabine) was estimated by Cox regression.|Analysis stratified by region of enrollment, number of prior chemotherapeutic regimens (0-1 or greater than \[\>\] 1), and visceral/ non-visceral disease.||0.771|0.549|<0.0001
72510729|NCT00829166|144551921|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.682||||0.0006|TWO_SIDED|95.0|0.548|0.849|||Log Rank||HR (relative to Lapatinib + Capecitabine) was estimated by Cox regression.|Analysis stratified by region of enrollment, number of prior chemotherapeutic regimens (0-1 or \>1), and visceral/ non-visceral disease.||0.849|0.548|0.0006
72510730|NCT00829166|144551923|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.749||||0.0003|TWO_SIDED|95.0|0.639|0.877|||Log Rank||HR (relative to Lapatinib + Capecitabine) was estimated by Cox regression.|Analysis stratified by region of enrollment, number of prior chemotherapeutic regimens (0-1 or \>1), and visceral/ non-visceral disease.||0.877|0.639|0.0003
72566893|NCT02312713|144664447|SUPERIORITY||Mean Difference (Final Values)|1.99||||0.05|TWO_SIDED|95.0|0.01|3.97|||Mixed Models Analysis|||This is the comparison between Internet Based Exercise Training and Wait List Control at 12 months for Aerobic Exercise.||3.97|0.01|0.05
72402008|NCT02515942|144311354|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|1.29||||0.2582|TWO_SIDED|80.0|-1.27|3.85|||Mixed Models Analysis|||Change from baseline at Day 85||3.85|-1.27|0.2582
72402009|NCT02515942|144311354|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|0.81||||0.3402|TWO_SIDED|80.0|-1.72|3.34|||Mixed Models Analysis|||Change from baseline at Day 85||3.34|-1.72|0.3402
72402010|NCT02515942|144311354|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-0.48||||0.5976|TWO_SIDED|80.0|-2.99|2.03|||Mixed Models Analysis|||Change from baseline at Day 85||2.03|-2.99|0.5976
72510731|NCT00829166|144551927|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.658|||<|0.0001|TWO_SIDED|95.0|0.56|0.774|||Log Rank||HR (relative to Lapatinib + Capecitabine) was estimated by Cox regression.|Analysis stratified by region of enrollment, number of prior chemotherapeutic regimens (0-1 or \>1), and visceral/ non-visceral disease.||0.774|0.560|<0.0001
72510732|NCT00829166|144551928|SUPERIORITY_OR_OTHER||Difference in Objective Response Rates|12.7||||0.0002|TWO_SIDED|95.0|6.0|19.4|||Mantel-Haenszel chi-squared test||The 95% CI for the difference in objective response rate (Trastuzumab emtansine minus Lapatinib + Capecitabine) was computed by using the approximate normal method.|Analysis stratified by region of enrollment, number of prior chemotherapeutic regimens (0-1 or \>1), and visceral/ non-visceral disease.||19.4|6.0|0.0002
72510733|NCT00829166|144551930|SUPERIORITY_OR_OTHER||Difference in Clinical Benefit Rate|14.0|||||TWO_SIDED|95.0|7.0|20.9|||||The 95% CI for the difference in clinical benefit rate (Trastuzumab emtansine minus Lapatinib + Capecitabine) was computed by using the normal approximation method.|||20.9|7.0|
72510734|NCT00829166|144551932|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.703|||<|0.0001|TWO_SIDED|95.0|0.602|0.82|||Log Rank||HR (relative to Lapatinib + Capecitabine) was estimated by Cox regression.|Analysis stratified by region of enrollment, number of prior chemotherapeutic regimens (0-1 or \>1), and visceral/ non-visceral disease.||0.820|0.602|<0.0001
72510735|NCT00829166|144551934|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.796||||0.0121|TWO_SIDED|95.0|0.667|0.951|||Log Rank||HR (relative to Lapatinib + Capecitabine) was estimated by Cox regression.|Analysis stratified by region of enrollment, number of prior chemotherapeutic regimens (0-1 or \>1), and visceral/ non-visceral disease.||0.951|0.667|0.0121
72510736|NCT03510663|144551945|SUPERIORITY||Least Squares Mean Difference|1.8|||||TWO_SIDED|90.0|-0.4|4.1||||||1 hour postdose||4.1|-0.4|
72510737|NCT03510663|144551945|SUPERIORITY||Least Squares Mean Difference|2.7|||||TWO_SIDED|90.0|0.4|4.9||||||1.5 hours postdose||4.9|0.4|
72510738|NCT03510663|144551945|SUPERIORITY||Least Squares Mean Difference|2.1|||||TWO_SIDED|90.0|-0.1|4.4||||||2 hours postdose||4.4|-0.1|
72510739|NCT03510663|144551945|SUPERIORITY||Least Squares Mean Difference|-0.5|||||TWO_SIDED|90.0|-2.8|1.7||||||3 hours postdose||1.7|-2.8|
72510740|NCT03510663|144551945|SUPERIORITY||Least Squares Mean Difference|-4.1|||||TWO_SIDED|90.0|-6.3|-1.8||||||4 hours postdose||-1.8|-6.3|
72510741|NCT03510663|144551945|SUPERIORITY||Least Squares Mean Difference|-3.5|||||TWO_SIDED|90.0|-5.7|-1.2||||||6 hours postdose||-1.2|-5.7|
72510742|NCT03510663|144551945|SUPERIORITY||Least Squares Mean Difference|-4.9|||||TWO_SIDED|90.0|-7.1|-2.6||||||12 hours postdose||-2.6|-7.1|
72566894|NCT02312713|144664447|NON_INFERIORITY|Since there were not sufficient data in prior literature to specific an a priori non-inferiority margin, for this and other secondary outcomes we based conclusions and discussions on magnitude of differences between the group, descriptively. This strategy was specified in the protocol.|Mean Difference (Final Values)|0.79||||0.27|TWO_SIDED|95.0|-0.62|2.2|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Internet Based Exercise Training at 4 months for Aerobic Exercise.||2.2|-0.62|0.27
72510743|NCT03510663|144551945|SUPERIORITY||Least Squares Mean Difference|-0.9|||||TWO_SIDED|90.0|-3.1|1.4||||||24 hours postdose||1.4|-3.1|
72510744|NCT03510663|144551945|SUPERIORITY||Least Squares Mean Difference|0.9|||||TWO_SIDED|90.0|-1.4|3.1||||||1 hour postdose||3.1|-1.4|
72510745|NCT03510663|144551945|SUPERIORITY||Least Squares Mean Difference|2.0|||||TWO_SIDED|90.0|-0.2|4.2||||||1.5 hours postdose||4.2|-0.2|
72510746|NCT03510663|144551945|SUPERIORITY||Least Squares Mean Difference|0.9|||||TWO_SIDED|90.0|-1.4|3.1||||||2 hours postdose||3.1|-1.4|
72510747|NCT03510663|144551945|SUPERIORITY||Least Squares Mean Difference|-1.6|||||TWO_SIDED|90.0|-3.8|0.7||||||3 hours postdose||0.7|-3.8|
72510748|NCT03510663|144551945|SUPERIORITY||Least Squares Mean Difference|-3.7|||||TWO_SIDED|90.0|-5.9|-1.5||||||4 hours postdose||-1.5|-5.9|
72510749|NCT03510663|144551945|SUPERIORITY||Least Squares Mean Difference|-2.3|||||TWO_SIDED|90.0|-4.6|-0.1||||||6 hours postdose||-0.1|-4.6|
72510750|NCT03510663|144551945|SUPERIORITY||Least Squares Mean Difference|-5.1|||||TWO_SIDED|90.0|-7.3|-2.8||||||12 hours postdose||-2.8|-7.3|
72510751|NCT03510663|144551945|SUPERIORITY||Least Squares Mean Difference|-0.2|||||TWO_SIDED|90.0|-2.4|2.1||||||24 hours postdose||2.1|-2.4|
72510752|NCT03510663|144551945|SUPERIORITY||Least Squares Mean Difference|10.8|||||TWO_SIDED|98.0|7.6|14.0||||||1 hour postdose||14.0|7.6|
72510753|NCT03510663|144551945|SUPERIORITY||Least Squares Mean Difference|10.2|||||TWO_SIDED|98.0|7.0|13.4||||||1.5 hours postdose||13.4|7.0|
72510754|NCT03510663|144551945|SUPERIORITY||Least Squares Mean Difference|11.2|||||TWO_SIDED|98.0|8.0|14.4||||||2 hours postdose||14.4|8.0|
72510755|NCT03510663|144551945|SUPERIORITY||Least Squares Mean Difference|11.5|||||TWO_SIDED|98.0|8.3|14.7||||||3 hours postdose||14.7|8.3|
72510756|NCT03510663|144551945|SUPERIORITY||Least Squares Mean Difference|9.7|||||TWO_SIDED|98.0|6.5|12.8||||||4 hours postdose||12.8|6.5|
72510757|NCT03510663|144551945|SUPERIORITY||Least Squares Mean Difference|10.4|||||TWO_SIDED|98.0|7.2|13.5||||||6 hours postdose||13.5|7.2|
72510758|NCT03510663|144551945|SUPERIORITY||Least Squares Mean Difference|7.3|||||TWO_SIDED|98.0|4.1|10.4||||||12 hours postdose||10.4|4.1|
72482078|NCT03444324|144491732|NON_INFERIORITY|The primary efficacy analysis of this endpoint was to test non-inferiority in the Per-protocol Set. The final analysis was performed using a two-way analysis of variance (ANOVA). Non-inferiority was to be demonstrated if the upper confidence limit of the two-sided 95 % confidence interval (CI) for the difference in the least squares mean (LSM) was less than the non-inferiority margin (150 mL).|Difference in LSM|-279.43|||<|0.001|TWO_SIDED|95.0|-552.38|-6.48||p-value from Van Elteren test, stratified by predictive blood loss (\> 1,000 mL to = 2,000 mL and \>2,000 mL)|Van Elteren test|||||-6.48|-552.38|<0.001
72482079|NCT03444324|144491733|OTHER||Difference in response rate|38.1|||<|0.001|TWO_SIDED|95.0|26.0|50.3|||Cochran-Mantel-Haenszel|P-value is from a Cochran-Mantel-Haenszel model stratified by predictive blood loss (\> 1,000 mL to ≤ 2,000 mL and \> 2,000 mL).||||50.3|26|<0.001
72482080|NCT03444324|144491734|OTHER||||||<|0.001|||||||Chi-squared|||||||<0.001
72482081|NCT03444324|144491740|OTHER||Difference in LSM|-15.5|||<|0.831|TWO_SIDED|95.0|-157.83|126.88|||ANOVA|||||126.88|-157.83|<0.831
72482082|NCT03444324|144491741|OTHER||Difference in LSM|12.4|||=|0.809|TWO_SIDED|95.0|-88.84|113.66|||ANOVA|||||113.66|-88.84|=0.809
72482083|NCT03444324|144491742|OTHER||Difference in proportion|-4.8|||=|0.022|TWO_SIDED|95.0|-8.9|-0.7|||Cochran-Mantel-Haenszel|||||-0.7|-8.9|=0.022
72482084|NCT06515483|144491763|OTHER||Mean Difference (Final Values)|0.079||||0.323|TWO_SIDED|95.0|-0.095|0.254||The threshold for statistical significance was p \< 0.05.|Wilcoxon (Mann-Whitney)||Comparing baseline PLI between groups|Due to non-normally distributed data, differences in each index between the experimental and control groups at baseline were compared using non-parametric Wilcoxon Rank Sum tests.||0.254|-0.095|0.323
72482085|NCT06515483|144491763|OTHER||Mean Difference (Final Values)|-0.036||||0.371|TWO_SIDED|95.0|-0.156|0.084||The threshold for statistical significance was p \< 0.05.|Wilcoxon (Mann-Whitney)||Comparing 30-day PLI between groups|Due to non-normally distributed data, differences in each index between the experimental and control groups at 30 days were compared using non-parametric Wilcoxon Rank Sum tests.||0.084|-0.156|0.371
72482086|NCT06515483|144491763|OTHER||Mean Difference (Net)|-0.115||||0.12|TWO_SIDED|95.0|-0.262|0.031||The threshold for statistical significance was p \< 0.05.|t-test, 2 sided||Comparing the mean difference in PLI from baseline to 30 days between groups|||0.031|-0.262|0.120
72482087|NCT06515483|144491764|OTHER||Mean Difference (Final Values)|0.078||||0.27|TWO_SIDED|95.0|-0.048|0.204||The threshold for statistical significance was p \< 0.05.|Wilcoxon (Mann-Whitney)||Comparing baseline MGI between groups|Due to non-normally distributed data, differences in each index between the experimental and control groups at baseline were compared using non-parametric Wilcoxon Rank Sum tests.||0.204|-0.048|0.270
72482088|NCT06515483|144491764|OTHER||Mean Difference (Final Values)|-0.085||||0.071|TWO_SIDED|95.0|-0.203|0.033||The threshold for statistical significance was p \< 0.05.|Wilcoxon (Mann-Whitney)||Comparing 30-day MGI between groups|Due to non-normally distributed data, differences in each index between the experimental and control groups at 30 days were compared using non-parametric Wilcoxon Rank Sum tests.||0.033|-0.203|0.071
72482089|NCT06515483|144491764|OTHER||Mean Difference (Net)|-0.163|||<|0.001|TWO_SIDED|95.0|-0.249|-0.077|||t-test, 2 sided||Comparing the mean difference in MGI from baseline to 30 days between groups|||-0.077|-0.249|<0.001
72482090|NCT06515483|144491765|OTHER||Mean Difference (Final Values)|0.31||||0.902|TWO_SIDED|95.0|-6.23|6.85||The threshold for statistical significance was p \< 0.05.|Wilcoxon (Mann-Whitney)||Comparing baseline BOMP between groups|Due to non-normally distributed data, differences in each index between the experimental and control groups at baseline were compared using non-parametric Wilcoxon Rank Sum tests.||6.85|-6.23|0.902
72482091|NCT06515483|144491765|OTHER||Mean Difference (Final Values)|-8.22||||0.006|TWO_SIDED|95.0|-16.46|0.02||The threshold for statistical significance was p \< 0.05.|Wilcoxon (Mann-Whitney)||Comparing 30-day BOMP between groups|Due to non-normally distributed data, differences in each index between the experimental and control groups at 30 days were compared using non-parametric Wilcoxon Rank Sum tests.||0.02|-16.46|0.006
72482092|NCT06515483|144491765|OTHER||Mean Difference (Net)|-8.53||||0.032|TWO_SIDED|95.0|-16.31|-0.75||The threshold for statistical significance was p \< 0.05.|t-test, 2 sided||Comparing the mean difference in BOMP from baseline to 30 days between groups|||-0.75|-16.31|0.032
72482093|NCT02425644|144491781|SUPERIORITY||Rate ratio|0.695||||0.0003|TWO_SIDED|99.0|0.536|0.902|||Negative binomial regression model|||||0.902|0.536|0.0003
72482094|NCT02425644|144491782|SUPERIORITY||Mean Difference (Final Values)|-3.57||||0.0019|TWO_SIDED|95.0|-5.83|-1.32|||Mixed Models Analysis|||||-1.32|-5.83|0.0019
72482095|NCT02425644|144491783|SUPERIORITY||Rate Ratio|0.444|||<|0.0001|TWO_SIDED|95.0|0.364|0.542|||Negative binomial regression model|||||0.542|0.364|<.0001
72482096|NCT02425644|144491784|SUPERIORITY||Hazard Ratio (HR)|0.83||||0.2939|TWO_SIDED|95.0|0.58|1.18|||Log Rank|||||1.18|0.58|0.2939
72482097|NCT02425644|144491785|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.372|TWO_SIDED|95.0|0.57|1.24|||Log Rank|||||1.24|0.57|0.3720
72482098|NCT00568321|144491816|SUPERIORITY||LS Mean difference|0.21|STANDARD_ERROR_OF_MEAN|0.43||0.687|TWO_SIDED|90.0|-0.5|0.92|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Least square (LS) mean difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.92|-0.50|0.687
72482099|NCT00568321|144491816|SUPERIORITY||LS Mean difference|-0.53|STANDARD_ERROR_OF_MEAN|0.44||0.111|TWO_SIDED|90.0|-1.25|0.19|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||LS mean difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.19|-1.25|0.111
72510759|NCT03510663|144551945|SUPERIORITY||Least Squares Mean Difference|7.0|||||TWO_SIDED|98.0|3.8|10.2||||||24 hours postdose||10.2|3.8|
72510760|NCT01555463|144551952|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Cochran-Mantel-Haenszel|center-adjusted||||||<.001
72510761|NCT01555463|144551953|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||ANCOVA|F-test for treatment effect of the ANCOVA model with treatment group and study center as the factors and baseline lesion count as the covariate.||||||<.001
72510762|NCT02026271|144551971|OTHER||||||||||||||||||"MTD was not determined in this study. Dose escalation decision rules were based on a standard 3+3 design modified to independently evaluate the two stratified subject groups that may exhibit different safety and tolerability profiles.~The study was planned to explore 4 veledimex (V) dose cohorts of 20, 40, 80 and 120 mg once daily, and two doses of Ad-RTS-hIL-12 (2x10\^11vp and 1x10\^12vp). Dose cohorts were treated at 10, 20, 30 and 40 mg of V. Only one dose of Ad-RTS-hIL-12 was explored (2x10\^11vp).~If ≥ 33% of subjects in the expansion cohort experience DLTs, additional subjects may be enrolled at the next lower dose, or at an intermediate dose, as recommended by the SRC.~Grp 1: After 20mg cohort, SRC approved 40mg, which was deemed the MAD due to DLTs. SRC approved 30mg cohort to determine MTD, but due to poor compliance, SRC opened a 20mg exp cohort and then an intermediate 10mg cohort. Based on V compliance and efficacy, 20mg was determined to be the optimal dose."|||
72402011|NCT02515942|144311354|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-0.5||||0.5916|TWO_SIDED|80.0|-3.3|2.29|||Mixed Models Analysis|||Change from baseline at Day 113||2.29|-3.30|0.5916
72402012|NCT02515942|144311354|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-0.3||||0.5564|TWO_SIDED|80.0|-3.05|2.45|||Mixed Models Analysis|||Change from baseline at Day 113||2.45|-3.05|0.5564
72402013|NCT02515942|144311354|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|0.2||||0.4625|TWO_SIDED|80.0|-2.53|2.93|||Mixed Models Analysis|||Change from baseline at Day 113||2.93|-2.53|0.4625
72482100|NCT00568321|144491817|SUPERIORITY||LS Mean Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.41||0.399|TWO_SIDED|90.0|-0.79|0.58|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 1: LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.58|-0.79|0.399
72510763|NCT04370028|144551978|SUPERIORITY||Mean Difference (Net)|4.57|||<|1e-05|TWO_SIDED|95.0|4.42|4.72|||t-test, 2 sided|Paired test was performed||||4.72|4.42|<0.00001
72510764|NCT04370028|144551979|SUPERIORITY||Odds Ratio (OR)|7.2|||<|1e-05|TWO_SIDED|95.0|6.01|8.67|||Fisher Exact||OR estimated (week 1 to week 12) the higher the better|Odds ratio of occuring MoCA score \<26 was assessed||8.67|6.01|<0.00001
72482101|NCT00568321|144491817|SUPERIORITY||LS Mean Difference|-0.37|STANDARD_ERROR_OF_MEAN|0.42||0.189|TWO_SIDED|90.0|-1.06|0.32|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 1: LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.32|-1.06|0.189
72482102|NCT00568321|144491817|SUPERIORITY||LS Mean Difference|0.35|STANDARD_ERROR_OF_MEAN|0.42||0.802|TWO_SIDED|90.0|-0.33|1.04|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 2: LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.04|-0.33|0.802
72482103|NCT00568321|144491817|SUPERIORITY||LS Mean Difference|0.09|STANDARD_ERROR_OF_MEAN|0.42||0.582|TWO_SIDED|90.0|-0.61|0.78|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 2: LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.78|-0.61|0.582
72510765|NCT04370028|144551980|SUPERIORITY||Odds Ratio (OR)|5.31|||<|1e-05|TWO_SIDED|95.0|4.28|6.64|||Fisher Exact||OR estimated (week 1 to week 12) the higher the better|Odds ratio of occuring MoCA score \<17 was assessed||6.64|4.28|<0.00001
72510766|NCT04370028|144551981|SUPERIORITY||Mean Difference (Net)|2.375|||<|0.07|TWO_SIDED|95.0|-0.21|4.96|||ANOVA|||Change of mean MoCA score||4.96|-0.21|<0.07
72510767|NCT04370028|144551981|SUPERIORITY||Mean Difference (Net)|4.74|||<|0.01|TWO_SIDED|95.0|4.17|5.31|||ANOVA|||Change of mean MoCA score||5.31|4.17|<0.01
72510768|NCT04370028|144551981|SUPERIORITY||Mean Difference (Net)|4.55|||<|0.01|TWO_SIDED|95.0|4.16|4.94|||ANOVA|||Change of mean MoCA score||4.94|4.16|<0.01
72482104|NCT00568321|144491817|SUPERIORITY||LS Mean Difference|0.34|STANDARD_ERROR_OF_MEAN|0.42||0.789|TWO_SIDED|90.0|-0.36|1.04|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 4: LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.04|-0.36|0.789
72482105|NCT00568321|144491817|SUPERIORITY||LS Mean Difference|-0.24|STANDARD_ERROR_OF_MEAN|0.42||0.29|TWO_SIDED|90.0|-0.94|0.47|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 4: LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.47|-0.94|0.290
72510769|NCT04370028|144551981|SUPERIORITY||Mean Difference (Net)|4.49|||<|0.01|TWO_SIDED|95.0|3.7|5.27|||ANOVA|||Change of mean MoCA score||5.27|3.7|<0.01
72482106|NCT00568321|144491817|SUPERIORITY||LS Mean Difference|0.08|STANDARD_ERROR_OF_MEAN|0.44||0.568|TWO_SIDED|90.0|-0.65|0.81|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 8: LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.81|-0.65|0.568
72510770|NCT04370028|144551983|SUPERIORITY||Mean Difference (Net)|0.803|STANDARD_ERROR_OF_MEAN|0.246||0.0011|TWO_SIDED|95.0|0.321|1.28|||ANOVA|||||1.28|0.321|0.0011
72402014|NCT02515942|144311354|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-1.94||||0.8221|TWO_SIDED|80.0|-4.64|0.76|||Mixed Models Analysis|||Change from baseline at Day 141||0.76|-4.64|0.8221
72402015|NCT02515942|144311354|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|0.98||||0.3179|TWO_SIDED|80.0|-1.68|3.64|||Mixed Models Analysis|||Change from baseline at Day 141||3.64|-1.68|0.3179
72402016|NCT02515942|144311354|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|2.92||||0.0773|TWO_SIDED|80.0|0.29|5.55|||Mixed Models Analysis|||Change from baseline at Day 141||5.55|0.29|0.0773
72402017|NCT02515942|144311354|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-0.95||||0.6708|TWO_SIDED|80.0|-3.71|1.81|||Mixed Models Analysis|||Change from baseline at Day 169||1.81|-3.71|0.6708
72402018|NCT02515942|144311354|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-0.99||||0.679|TWO_SIDED|80.0|-3.71|1.74|||Mixed Models Analysis|||Change from baseline at Day 169||1.74|-3.71|0.6790
72402019|NCT02515942|144311354|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-0.04||||0.507|TWO_SIDED|80.0|-2.72|2.64|||Mixed Models Analysis|||Change from baseline at Day 169||2.64|-2.72|0.5070
72402020|NCT02515942|144311354|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-0.3||||0.5487|TWO_SIDED|80.0|-3.44|2.84|||Mixed Models Analysis|||Change from baseline at Day 197||2.84|-3.44|0.5487
72482107|NCT00568321|144491817|SUPERIORITY||LS Mean Difference|-0.54|STANDARD_ERROR_OF_MEAN|0.45||0.116|TWO_SIDED|90.0|-1.27|0.2|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 8: LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.20|-1.27|0.116
72482108|NCT00568321|144491817|SUPERIORITY||LS Mean Difference|-0.36|STANDARD_ERROR_OF_MEAN|0.46||0.218|TWO_SIDED|90.0|-1.11|0.4|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 12: LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.40|-1.11|0.218
72482109|NCT00568321|144491817|SUPERIORITY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.46||0.261|TWO_SIDED|90.0|-1.06|0.47|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 12: LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.47|-1.06|0.261
72482110|NCT00568321|144491817|SUPERIORITY||LS Mean Difference|-0.32|STANDARD_ERROR_OF_MEAN|0.48||0.252|TWO_SIDED|90.0|-1.11|0.47|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 16: LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.47|-1.11|0.252
72482111|NCT00568321|144491817|SUPERIORITY||LS Mean Difference|-0.45|STANDARD_ERROR_OF_MEAN|0.49||0.182|TWO_SIDED|90.0|-1.26|0.36|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 16: LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.36|-1.26|0.182
72510771|NCT03302416|144552000|SUPERIORITY|Baseline scan VT vs. Post-hydrocortisone scan VT||||||0.005|||||||Linear mixed model|||||||0.005
72510772|NCT05513053|144552005|NON_INFERIORITY|Non-inferiority was concluded if the lower limit of the two-sided 95% confidence interval (CI) of the ratio of GMTs between groups (9 to 17 years/18 to 49 years) was \> 0.667 for each strain.|GMT Ratio|1.98|||||TWO_SIDED|95.0|1.73|2.27||||||Statistical analysis for A/H1N1||2.27|1.73|
72510773|NCT05513053|144552005|NON_INFERIORITY|Non-inferiority was concluded if the lower limit of the two-sided 95% CI of the ratio of GMTs between groups (9 to 17 years/18 to 49 years) was \> 0.667 for each strain.|GMT Ratio|3.27|||||TWO_SIDED|95.0|2.76|3.87||||||Statistical analysis for A/H3N2||3.87|2.76|
72566895|NCT02312713|144664447|NON_INFERIORITY|Since there were not sufficient data in prior literature to specific an a priori non-inferiority margin, for this and other secondary outcomes we based conclusions and discussions on magnitude of differences between the group, descriptively. This strategy was specified in the protocol.|Mean Difference (Final Values)|-0.07||||0.93|TWO_SIDED|95.0|-1.69|1.54|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Internet Based Exercise Training at 12 months for Aerobic Exercise.||1.54|-1.69|0.93
72566896|NCT02654587|144664490|SUPERIORITY||Hazard Ratio (HR)|0.59|||<|0.05|TWO_SIDED|95.0|0.38|0.91||OS in patients with ICI secondary resistance|t-test, 2 sided||p=0.017|||0.91|0.38|<0.05
72482112|NCT00568321|144491818|SUPERIORITY||LS Mean Difference|0.19|STANDARD_ERROR_OF_MEAN|0.39||0.683|TWO_SIDED|90.0|-0.46|0.84|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Weeks 1 to 4: LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.84|-0.46|0.683
72482113|NCT00568321|144491818|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.4||0.31|TWO_SIDED|90.0|-0.85|0.46|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Weeks 1 to 4: LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.46|-0.85|0.310
72482114|NCT00568321|144491818|SUPERIORITY||LS Mean Difference|0.16|STANDARD_ERROR_OF_MEAN|0.37||0.668|TWO_SIDED|90.0|-0.46|0.78|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Weeks 1 to 8: LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.78|-0.46|0.668
72482115|NCT00568321|144491818|SUPERIORITY||LS Mean Difference|-0.37|STANDARD_ERROR_OF_MEAN|0.38||0.165|TWO_SIDED|90.0|-0.99|0.26|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Weeks 1 to 8: LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.26|-0.99|0.165
72482116|NCT00568321|144491818|SUPERIORITY||LS Mean Difference|0.04|STANDARD_ERROR_OF_MEAN|0.36||0.546|TWO_SIDED|90.0|-0.55|0.64|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Weeks 1 to 12: LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.64|-0.55|0.546
72482117|NCT00568321|144491818|SUPERIORITY||LS Mean Difference|-0.32|STANDARD_ERROR_OF_MEAN|0.36||0.19|TWO_SIDED|90.0|-0.92|0.28|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Weeks 1 to 12: LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.28|-0.92|0.190
72482118|NCT00568321|144491818|SUPERIORITY||LS Mean Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.35||0.467|TWO_SIDED|90.0|-0.6|0.55|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Weeks 1 to 16: LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.55|-0.60|0.467
72482119|NCT00568321|144491818|SUPERIORITY||LS Mean Difference|-0.36|STANDARD_ERROR_OF_MEAN|0.35||0.153|TWO_SIDED|90.0|-0.94|0.22|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Weeks 1 to 16: LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.22|-0.94|0.153
72482120|NCT00568321|144491818|SUPERIORITY||LS Mean Difference|0.14|STANDARD_ERROR_OF_MEAN|0.41||0.632|TWO_SIDED|90.0|-0.54|0.81|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Weeks 5 to 8: LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.81|-0.54|0.632
72482121|NCT00568321|144491818|SUPERIORITY||LS Mean Difference|-0.54|STANDARD_ERROR_OF_MEAN|0.41||0.094|TWO_SIDED|90.0|-1.22|0.14|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Weeks 5 to 8: LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.14|-1.22|0.094
72482122|NCT00568321|144491818|SUPERIORITY||LS Mean Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.39||0.468|TWO_SIDED|90.0|-0.68|0.61|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Weeks 5 to 12: LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.61|-0.68|0.468
72482123|NCT00568321|144491818|SUPERIORITY||LS Mean Difference|-0.38|STANDARD_ERROR_OF_MEAN|0.39||0.167|TWO_SIDED|90.0|-1.03|0.27|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Weeks 5 to 12: LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.27|-1.03|0.167
72482124|NCT00568321|144491818|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.37||0.394|TWO_SIDED|90.0|-0.72|0.52|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Weeks 5 to 16: LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.52|-0.72|0.394
72510774|NCT05513053|144552005|NON_INFERIORITY|Non-inferiority was concluded if the lower limit of the two-sided 95% CI of the ratio of GMTs between groups (9 to 17 years/18 to 49 years) was \> 0.667 for each strain.|GMT Ratio|1.57|||||TWO_SIDED|95.0|1.35|1.82||||||Statistical analysis for B/Victoria||1.82|1.35|
72510775|NCT05513053|144552005|NON_INFERIORITY|Non-inferiority was concluded if the lower limit of the two-sided 95% CI of the ratio of GMTs between groups (9 to 17 years/18 to 49 years) was \> 0.667 for each strain.|GMT Ratio|1.22|||||TWO_SIDED|95.0|1.09|1.37||||||Statistical analysis for B/Yamagata||1.37|1.09|
72510776|NCT05513053|144552006|NON_INFERIORITY|Non-inferiority for seroconversion rates was demonstrated if the lower limit of the 2-sided 95% CI was \>-10% for the 4 strains.|Percent Difference|1.92|||||TWO_SIDED|95.0|-2.78|6.62||||||Statistical analysis for A/H1N1||6.62|-2.78|
72510777|NCT05513053|144552006|NON_INFERIORITY|Non-inferiority for seroconversion rates was demonstrated if the lower limit of the 2-sided 95% CI was \>-10% for the 4 strains.|Percent Difference|-0.59|||||TWO_SIDED|95.0|-4.41|3.23||||||Statistical analysis for A/H3N2||3.23|-4.41|
72566897|NCT02654587|144664490|SUPERIORITY||Hazard Ratio (HR)|0.86||||0.36|TWO_SIDED|95.0|0.62|1.19|||t-test, 2 sided|||OS in the ITT population with ICI resistance (primary and secondary resistance)||1.19|0.62|0.36
72402021|NCT02515942|144311354|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-1.25||||0.6973|TWO_SIDED|80.0|-4.35|1.85|||Mixed Models Analysis|||Change from baseline at Day 197||1.85|-4.35|0.6973
72482125|NCT00568321|144491818|SUPERIORITY||LS Mean Difference|-0.41|STANDARD_ERROR_OF_MEAN|0.38||0.138|TWO_SIDED|90.0|-1.04|0.21|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Weeks 5 to 16: LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.21|-1.04|0.138
72482126|NCT00568321|144491819|SUPERIORITY||LS Mean Difference|0.39|STANDARD_ERROR_OF_MEAN|0.55||0.764|TWO_SIDED|90.0|-0.51|1.3|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 1 (Worst pain): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.30|-0.51|0.764
72482127|NCT00568321|144491819|SUPERIORITY||LS Mean Difference|0.37|STANDARD_ERROR_OF_MEAN|0.55||0.75|TWO_SIDED|90.0|-0.54|1.28|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 1 (Worst pain): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.28|-0.54|0.750
72482128|NCT00568321|144491819|SUPERIORITY||LS Mean Difference|0.28|STANDARD_ERROR_OF_MEAN|0.45||0.734|TWO_SIDED|90.0|-0.46|1.03|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 1 (Average pain): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.03|-0.46|0.734
72482129|NCT00568321|144491819|SUPERIORITY||LS Mean Difference|0.02|STANDARD_ERROR_OF_MEAN|0.45||0.514|TWO_SIDED|90.0|-0.73|0.77|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 1 (Average pain): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.77|-0.73|0.514
72482130|NCT00568321|144491819|SUPERIORITY||LS Mean Difference|1.37|STANDARD_ERROR_OF_MEAN|1.89||0.765|TWO_SIDED|90.0|-1.76|4.5|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 1 (Pain severity): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||4.50|-1.76|0.765
72482131|NCT00568321|144491819|SUPERIORITY||LS Mean Difference|0.71|STANDARD_ERROR_OF_MEAN|1.9||0.646|TWO_SIDED|90.0|-2.43|3.86|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 1 (Pain severity): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||3.86|-2.43|0.646
72482132|NCT00568321|144491819|SUPERIORITY||LS Mean Difference|0.69|STANDARD_ERROR_OF_MEAN|0.55||0.895|TWO_SIDED|90.0|-0.22|1.6|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 2 (Worst pain): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.60|-0.22|0.895
72482133|NCT00568321|144491819|SUPERIORITY||LS Mean Difference|0.42|STANDARD_ERROR_OF_MEAN|0.56||0.776|TWO_SIDED|90.0|-0.5|1.34|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 2 (Worst pain): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.34|-0.50|0.776
72482134|NCT00568321|144491819|SUPERIORITY||LS Mean Difference|0.72|STANDARD_ERROR_OF_MEAN|0.45||0.944|TWO_SIDED|90.0|-0.03|1.47|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 2 (Average pain): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.47|-0.03|0.944
72482135|NCT00568321|144491819|SUPERIORITY||LS Mean Difference|0.45|STANDARD_ERROR_OF_MEAN|0.46||0.835|TWO_SIDED|90.0|-0.31|1.21|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 2 (Average pain): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.21|-0.31|0.835
72482136|NCT00568321|144491819|SUPERIORITY||LS Mean Difference|3.23|STANDARD_ERROR_OF_MEAN|1.9||0.955|TWO_SIDED|90.0|0.09|6.37|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 2 (Pain severity): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||6.37|0.09|0.955
72482137|NCT00568321|144491819|SUPERIORITY||LS Mean Difference|2.31|STANDARD_ERROR_OF_MEAN|1.93||0.884|TWO_SIDED|90.0|-0.88|5.49|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 2 (Pain severity): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||5.49|-0.88|0.884
72510778|NCT05513053|144552006|NON_INFERIORITY|Non-inferiority for seroconversion rates was demonstrated if the lower limit of the 2-sided 95% CI was \>-10% for the 4 strains.|Percent Difference|3.29|||||TWO_SIDED|95.0|-1.57|8.14||||||Statistical analysis for B/Victoria||8.14|-1.57|
72482138|NCT00568321|144491819|SUPERIORITY||LS Mean Difference|0.36|STANDARD_ERROR_OF_MEAN|0.56||0.737|TWO_SIDED|90.0|-0.57|1.28|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 4 (Worst pain): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.28|-0.57|0.737
72482139|NCT00568321|144491819|SUPERIORITY||LS Mean Difference|0.18|STANDARD_ERROR_OF_MEAN|0.56||0.628|TWO_SIDED|90.0|-0.74|1.11|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 4 (Worst pain): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.11|-0.74|0.628
72482140|NCT00568321|144491819|SUPERIORITY||LS Mean Difference|0.67|STANDARD_ERROR_OF_MEAN|0.46||0.925|TWO_SIDED|90.0|-0.1|1.43|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 4 (Average pain): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.43|-0.10|0.925
72482141|NCT00568321|144491819|SUPERIORITY||LS Mean Difference|0.02|STANDARD_ERROR_OF_MEAN|0.46||0.518|TWO_SIDED|90.0|-0.75|0.79|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 4 (Average pain): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.79|-0.75|0.518
72482142|NCT00568321|144491819|SUPERIORITY||LS Mean Difference|1.7|STANDARD_ERROR_OF_MEAN|1.93||0.81|TWO_SIDED|90.0|-1.49|4.88|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 4 (Pain severity): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||4.88|-1.49|0.810
72482143|NCT00568321|144491819|SUPERIORITY||LS Mean Difference|0.49|STANDARD_ERROR_OF_MEAN|1.94||0.6|TWO_SIDED|90.0|-2.72|3.7|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 4 (Pain severity): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||3.70|-2.72|0.600
72482144|NCT00568321|144491819|SUPERIORITY||LS Mean Difference|0.22|STANDARD_ERROR_OF_MEAN|0.58||0.651|TWO_SIDED|90.0|-0.73|1.18|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 6 (Worst pain): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.18|-0.73|0.651
72482145|NCT00568321|144491819|SUPERIORITY||LS Mean Difference|-0.24|STANDARD_ERROR_OF_MEAN|0.59||0.342|TWO_SIDED|90.0|-1.21|0.73|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 6 (Worst pain): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.73|-1.21|0.342
72482146|NCT00568321|144491819|SUPERIORITY||LS Mean Difference|0.35|STANDARD_ERROR_OF_MEAN|0.48||0.768|TWO_SIDED|90.0|-0.44|1.14|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 6 (Average pain): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.14|-0.44|0.768
72482147|NCT00568321|144491819|SUPERIORITY||LS Mean Difference|-0.39|STANDARD_ERROR_OF_MEAN|0.48||0.211|TWO_SIDED|90.0|-1.19|0.41|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 6 (Average pain): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.41|-1.19|0.211
72482148|NCT00568321|144491819|SUPERIORITY||LS Mean Difference|0.56|STANDARD_ERROR_OF_MEAN|1.99||0.61|TWO_SIDED|90.0|-2.73|3.85|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 6 (Pain severity): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||3.85|-2.73|0.610
72482149|NCT00568321|144491819|SUPERIORITY||LS Mean Difference|-1.43|STANDARD_ERROR_OF_MEAN|2.02||0.241|TWO_SIDED|90.0|-4.76|1.91|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 6 (Pain severity): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.91|-4.76|0.241
72482150|NCT00568321|144491819|SUPERIORITY||LS Mean Difference|0.48|STANDARD_ERROR_OF_MEAN|0.59||0.789|TWO_SIDED|90.0|-0.5|1.45|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 8 (Worst pain): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.45|-0.50|0.789
72482151|NCT00568321|144491819|SUPERIORITY||LS Mean Difference|0.11|STANDARD_ERROR_OF_MEAN|0.6||0.57|TWO_SIDED|90.0|-0.88|1.09|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 8 (Worst pain): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.09|-0.88|0.570
72482152|NCT00568321|144491819|SUPERIORITY||LS Mean Difference|0.38|STANDARD_ERROR_OF_MEAN|0.49||0.782|TWO_SIDED|90.0|-0.43|1.19|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 8 (Average pain): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.19|-0.43|0.782
72510779|NCT05513053|144552006|NON_INFERIORITY|Non-inferiority for seroconversion rates was demonstrated if the lower limit of the 2-sided 95% CI was \>-10% for the 4 strains.|Percent Difference|14.3|||||TWO_SIDED|95.0|9.17|19.3||||||Statistical analysis for B/Yamagata||19.3|9.17|
72566898|NCT02654587|144664491|SUPERIORITY||Hazard Ratio (HR)|0.46||||0.004|TWO_SIDED|95.0|0.27|0.79|||t-test, 2 sided|||Post-progression survival in patients with ICI secondary resistance||0.79|0.27|0.004
72566899|NCT02654587|144664491|SUPERIORITY||Hazard Ratio (HR)|0.57||||0.0035|TWO_SIDED|95.0|0.39|0.83|||t-test, 2 sided|||Post-progression survival in ITT population with ICI resistance (primary and secondary)||0.83|0.39|0.0035
72482153|NCT00568321|144491819|SUPERIORITY||LS Mean Difference|-0.27|STANDARD_ERROR_OF_MEAN|0.49||0.295|TWO_SIDED|90.0|-1.08|0.55|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 8 (Average pain): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.55|-1.08|0.295
72482154|NCT00568321|144491819|SUPERIORITY||LS Mean Difference|1.75|STANDARD_ERROR_OF_MEAN|2.04||0.804|TWO_SIDED|90.0|-1.62|5.11|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 8 (Pain severity): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||5.11|-1.62|0.804
72482155|NCT00568321|144491819|SUPERIORITY||LS Mean Difference|0.82|STANDARD_ERROR_OF_MEAN|2.06||0.655|TWO_SIDED|90.0|-2.58|4.22|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 8 (Pain severity): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||4.22|-2.58|0.655
72482156|NCT00568321|144491819|SUPERIORITY||LS Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.6||0.409|TWO_SIDED|90.0|-1.13|0.86|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 12 (Worst pain): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.86|-1.13|0.409
72482157|NCT00568321|144491819|SUPERIORITY||LS Mean Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.61||0.482|TWO_SIDED|90.0|-1.03|0.97|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 12 (Worst pain): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.97|-1.03|0.482
72482158|NCT00568321|144491819|SUPERIORITY||LS Mean Difference|0.12|STANDARD_ERROR_OF_MEAN|0.5||0.592|TWO_SIDED|90.0|-0.71|0.94|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 12 (Average pain): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.94|-0.71|0.592
72482159|NCT00568321|144491819|SUPERIORITY||LS Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.5||0.368|TWO_SIDED|90.0|-1.0|0.66|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 12 (Average pain): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.66|-1.00|0.368
72482160|NCT00568321|144491819|SUPERIORITY||LS Mean Difference|-0.55|STANDARD_ERROR_OF_MEAN|2.08||0.396|TWO_SIDED|90.0|-3.98|2.88|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 12 (Pain severity): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||2.88|-3.98|0.396
72482161|NCT00568321|144491819|SUPERIORITY||LS Mean Difference|0.24|STANDARD_ERROR_OF_MEAN|2.09||0.545|TWO_SIDED|90.0|-3.21|3.69|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 12 (Pain severity): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||3.69|-3.21|0.545
72482162|NCT00568321|144491819|SUPERIORITY||LS Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.62||0.486|TWO_SIDED|90.0|-1.04|1.0|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 16 (Worst pain): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.00|-1.04|0.486
72482163|NCT00568321|144491819|SUPERIORITY||LS Mean Difference|-0.29|STANDARD_ERROR_OF_MEAN|0.63||0.324|TWO_SIDED|90.0|-1.33|0.75|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 16 (Worst pain): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.75|-1.33|0.324
72482164|NCT00568321|144491819|SUPERIORITY||LS Mean Difference|0.08|STANDARD_ERROR_OF_MEAN|0.51||0.563|TWO_SIDED|90.0|-0.76|0.92|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 16 (Average pain): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.92|-0.76|0.563
72566900|NCT02654587|144664492|SUPERIORITY||Hazard Ratio (HR)|0.43||||0.006|TWO_SIDED|95.0|0.23|0.8|||t-test, 2 sided|||Time to worsening ECOG PS \>1 in patients with ICI secondary resistance||0.80|0.23|0.006
72566901|NCT02654587|144664492|SUPERIORITY||Hazard Ratio (HR)|0.57||||0.02|TWO_SIDED|95.0|0.35|0.92|||t-test, 2 sided|||Time to worsening ECOG PS in the ITT population with ICI resistance (primary and secondary)||0.92|0.35|0.02
72566902|NCT02654587|144664493|SUPERIORITY||P Value|0.045|||<|0.05|TWO_SIDED||||||Mixed Models Analysis|||QLQ C30 Global Health Status in Patients with ICI secondary resistance||||<0.05
72566903|NCT02654587|144664493|SUPERIORITY||P Value|0.07||||0.07|TWO_SIDED||||||Mixed Models Analysis|||QLQ-C30 Physical functioning in patients with ICI secondary resistance||||0.07
72482165|NCT00568321|144491819|SUPERIORITY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.52||0.282|TWO_SIDED|90.0|-1.16|0.56|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 16 (Average pain): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.56|-1.16|0.282
72482166|NCT00568321|144491819|SUPERIORITY||LS Mean Difference|-0.49|STANDARD_ERROR_OF_MEAN|2.12||0.409|TWO_SIDED|90.0|-3.99|3.01||P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.|Repeated Measures Model|||Week 16 (Pain severity): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||3.01|-3.99|0.409
72482167|NCT00568321|144491819|SUPERIORITY||LS Mean Difference|-1.18|STANDARD_ERROR_OF_MEAN|2.17||0.293|TWO_SIDED|90.0|-4.76|2.39||P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.|Repeated Measures Model|||Week 16 (Pain severity): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||2.39|-4.76|0.293
72482168|NCT00568321|144491826|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.5||0.343|TWO_SIDED|90.0|-1.03|0.62|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 1 (CS): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.62|-1.03|0.343
72482169|NCT00568321|144491826|SUPERIORITY||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.51||0.576|TWO_SIDED|90.0|-0.75|0.94|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 1 (CS): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.94|-0.75|0.576
72482170|NCT00568321|144491826|SUPERIORITY||LS Mean Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.63||0.46|TWO_SIDED|90.0|-1.1|0.98|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 1 (GA): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.98|-1.10|0.460
72482171|NCT00568321|144491826|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.63||0.435|TWO_SIDED|90.0|-1.15|0.94|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 1 (GA): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.94|-1.15|0.435
72482172|NCT00568321|144491826|SUPERIORITY||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.56||0.104|TWO_SIDED|90.0|-1.62|0.22|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 1 (NW): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.22|-1.62|0.104
72482173|NCT00568321|144491826|SUPERIORITY||LS Mean Difference|-0.48|STANDARD_ERROR_OF_MEAN|0.57||0.204|TWO_SIDED|90.0|-1.42|0.47|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 1 (NW): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.47|-1.42|0.204
72482174|NCT00568321|144491826|SUPERIORITY||LS Mean Difference|0.75|STANDARD_ERROR_OF_MEAN|0.5||0.931|TWO_SIDED|90.0|-0.08|1.58|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 2 (CS): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.58|-0.08|0.931
72482175|NCT00568321|144491826|SUPERIORITY||LS Mean Difference|0.81|STANDARD_ERROR_OF_MEAN|0.52||0.941|TWO_SIDED|90.0|-0.04|1.67|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 2 (CS): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.67|-0.04|0.941
72566904|NCT02654587|144664493|SUPERIORITY||P Value|0.03|||<|0.05|TWO_SIDED||||||Mixed Models Analysis|||QLQ-C30 Role functioning in patients with ICI secondary resistance||||<0.05
72566905|NCT02654587|144664493|SUPERIORITY||P Value|0.36||||0.36|TWO_SIDED||||||Mixed Models Analysis|||QLQ-C30 Emotional functioning in patients with ICI secondary resistance||||0.36
72510780|NCT03456713|144552077|OTHER||Ratio of geometric least squares mean|1.47|||||TWO_SIDED|90.0|1.12|1.94||||||||1.94|1.12|
72510781|NCT03456713|144552078|OTHER||Ratio of geometric least squares mean|1.44|||||TWO_SIDED|90.0|1.15|1.81||||||||1.81|1.15|
72510782|NCT03456713|144552079|OTHER||Ratio of geometric least squares mean|1.66|||||TWO_SIDED|90.0|1.31|2.11||||||||2.11|1.31|
72510783|NCT03456713|144552080|SUPERIORITY||Ratio of Geometric Least Squares Means|0.73|||||TWO_SIDED|90.0|0.43|1.23||||||||1.23|0.43|
72510784|NCT03456713|144552081|OTHER||Ratio of geometric least squares mean|0.98|||||TWO_SIDED|90.0|0.58|1.67||||||||1.67|0.58|
72510785|NCT03456713|144552082|OTHER||Ratio of geometric least squares mean|0.7|||||TWO_SIDED|90.0|0.41|1.2||||||||1.20|0.41|
72510786|NCT01405313|144552083|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority|Mean Difference (Final Values)|2.5||||0.022|TWO_SIDED|80.0|||||t-test, 1 sided|||||||0.022
72510787|NCT01405313|144552084|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority|Mean Difference (Final Values)|3.0||||0.016|TWO_SIDED|80.0|||||t-test, 1 sided|||||||0.016
72566906|NCT02654587|144664493|SUPERIORITY||P Value|0.24||||0.24|TWO_SIDED||||||Mixed Models Analysis|||QLQ-C30 Cognitive functioning in patients with ICI secondary resistance||||0.24
72566907|NCT02654587|144664493|SUPERIORITY|QLQ-C30 Social functioning|P Value|0.11||||0.11|TWO_SIDED||||||Mixed Models Analysis|||||||0.11
72482176|NCT00568321|144491826|SUPERIORITY||LS Mean Difference|0.96|STANDARD_ERROR_OF_MEAN|0.63||0.936|TWO_SIDED|90.0|-0.08|2.01|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 2 (GA): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||2.01|-0.08|0.936
72482177|NCT00568321|144491826|SUPERIORITY||LS Mean Difference|1.17|STANDARD_ERROR_OF_MEAN|0.64||0.965|TWO_SIDED|90.0|0.11|2.23|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 2 (GA): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||2.23|0.11|0.965
72482178|NCT00568321|144491826|SUPERIORITY||LS Mean Difference|0.59|STANDARD_ERROR_OF_MEAN|0.56||0.855|TWO_SIDED|90.0|-0.33|1.51|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 2 (NW): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.51|-0.33|0.855
72482179|NCT00568321|144491826|SUPERIORITY||LS Mean Difference|0.42|STANDARD_ERROR_OF_MEAN|0.58||0.765|TWO_SIDED|90.0|-0.54|1.38|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 2 (NW): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.38|-0.54|0.765
72482180|NCT00568321|144491826|SUPERIORITY||LS Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.51||0.504|TWO_SIDED|90.0|-0.84|0.85|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 4 (CS): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.85|-0.84|0.504
72482181|NCT00568321|144491826|SUPERIORITY||LS Mean Difference|0.19|STANDARD_ERROR_OF_MEAN|0.52||0.643|TWO_SIDED|90.0|-0.67|1.06|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 4 (CS): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.06|-0.67|0.643
72482182|NCT00568321|144491826|SUPERIORITY||LS Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.64||0.486|TWO_SIDED|90.0|-1.09|1.04|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 4 (GA): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.04|-1.09|0.486
72482183|NCT00568321|144491826|SUPERIORITY||LS Mean Difference|0.16|STANDARD_ERROR_OF_MEAN|0.65||0.6|TWO_SIDED|90.0|-0.91|1.24|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 4 (GA): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.24|-0.91|0.600
72482184|NCT00568321|144491826|SUPERIORITY||LS Mean Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.57||0.418|TWO_SIDED|90.0|-1.05|0.82|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 4 (NW): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.82|-1.05|0.418
72482185|NCT00568321|144491826|SUPERIORITY||LS Mean Difference|0.02|STANDARD_ERROR_OF_MEAN|0.59||0.515|TWO_SIDED|90.0|-0.95|0.99|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 4 (NW): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.99|-0.95|0.515
72482186|NCT00568321|144491826|SUPERIORITY||LS Mean Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.53||0.456|TWO_SIDED|90.0|-0.93|0.81|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 6 (CS): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.81|-0.93|0.456
72482187|NCT00568321|144491826|SUPERIORITY||LS Mean Difference|0.08|STANDARD_ERROR_OF_MEAN|0.54||0.556|TWO_SIDED|90.0|-0.82|0.97|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 6 (CS): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.97|-0.82|0.556
72482188|NCT00568321|144491826|SUPERIORITY||LS Mean Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.67||0.448|TWO_SIDED|90.0|-1.19|1.02|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 6 (GA): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.02|-1.19|0.448
72482189|NCT00568321|144491826|SUPERIORITY||LS Mean Difference|0.17|STANDARD_ERROR_OF_MEAN|0.68||0.6|TWO_SIDED|90.0|-0.95|1.3|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 6 (GA): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.30|-0.95|0.600
72510788|NCT03848221|144552085|EQUIVALENCE|||||||0.3|||||||ANOVA|||||||0.30
72510789|NCT03848221|144552086|EQUIVALENCE|||||||0.0002|||||||ANOVA|||||||0.0002
72510790|NCT01533935|144552138|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.265|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.215|0.315|||Mixed Models Analysis||Difference calculated as Tiotropium + olodaterol 5/5 QD minus Placebo QD|||0.315|0.215|<0.0001
72510791|NCT01533935|144552138|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.08|STANDARD_ERROR_OF_MEAN|0.025||0.0015|TWO_SIDED|95.0|0.031|0.129|||Mixed Models Analysis||Difference calculated as Tiotropium + olodaterol 5/5 QD minus Olodaterol 5 mcg QD|||0.129|0.031|0.0015
72566908|NCT02654587|144664494|SUPERIORITY||P Value|0.06||||0.06|TWO_SIDED||||||Mixed Models Analysis|||QLQ-C30 Fatigue in ICI secondary resistance||||0.06
72482190|NCT00568321|144491826|SUPERIORITY||LS Mean Difference|-0.44|STANDARD_ERROR_OF_MEAN|0.59||0.225|TWO_SIDED|90.0|-1.41|0.52|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 6 (NW): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.52|-1.41|0.225
72482191|NCT00568321|144491826|SUPERIORITY||LS Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.61||0.387|TWO_SIDED|90.0|-1.18|0.83|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 6 (NW): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.83|-1.18|0.387
72482192|NCT00568321|144491826|SUPERIORITY||LS Mean Difference|0.22|STANDARD_ERROR_OF_MEAN|0.54||0.657|TWO_SIDED|90.0|-0.67|1.11|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 8 (CS): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.11|-0.67|0.657
72482193|NCT00568321|144491826|SUPERIORITY||LS Mean Difference|0.48|STANDARD_ERROR_OF_MEAN|0.55||0.808|TWO_SIDED|90.0|-0.43|1.4|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 8 (CS): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.40|-0.43|0.808
72482194|NCT00568321|144491826|SUPERIORITY||LS Mean Difference|0.45|STANDARD_ERROR_OF_MEAN|0.68||0.742|TWO_SIDED|90.0|-0.68|1.57|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 8 (GA): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.57|-0.68|0.742
72482195|NCT00568321|144491826|SUPERIORITY||LS Mean Difference|0.99|STANDARD_ERROR_OF_MEAN|0.7||0.923|TWO_SIDED|90.0|-0.16|2.14|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 8 (GA): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||2.14|-0.16|0.923
72482196|NCT00568321|144491826|SUPERIORITY||LS Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.6||0.49|TWO_SIDED|90.0|-1.01|0.98|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 8 (NW): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.98|-1.01|0.490
72624017|NCT02231580|144778427|SUPERIORITY_OR_OTHER||GLS mean ratio|1.571|||=|0.0874|TWO_SIDED|90.0|1.018|2.424|||MMRM|||Left hand ITI variability statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||2.424|1.018|=0.0874
72482197|NCT00568321|144491826|SUPERIORITY||LS Mean Difference|0.17|STANDARD_ERROR_OF_MEAN|0.62||0.609|TWO_SIDED|90.0|-0.86|1.2|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 8 (NW): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.20|-0.86|0.609
72482198|NCT00568321|144491826|SUPERIORITY||LS Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.55||0.362|TWO_SIDED|90.0|-1.1|0.71|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 12 (CS): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.71|-1.10|0.362
72482199|NCT00568321|144491826|SUPERIORITY||LS Mean Difference|0.16|STANDARD_ERROR_OF_MEAN|0.56||0.61|TWO_SIDED|90.0|-0.77|1.09|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 12 (CS): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.09|-0.77|0.610
72482200|NCT00568321|144491826|SUPERIORITY||LS Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.7||0.376|TWO_SIDED|90.0|-1.37|0.93|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 12 (GA): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.93|-1.37|0.376
72510792|NCT01533935|144552138|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.088|STANDARD_ERROR_OF_MEAN|0.025||0.0005|TWO_SIDED|95.0|0.039|0.137|||Mixed Models Analysis||Difference calculated as Tiotropium + olodaterol 5/5 QD minus Tiotropium 5 mcg QD|||0.137|0.039|0.0005
72510793|NCT01533935|144552138|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.274|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.224|0.324|||Mixed Models Analysis||Difference calculated as Tiotropium + olodaterol 2.5/5 QD minus Placebo QD|||0.324|0.224|<0.0001
72510794|NCT01533935|144552138|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.089|STANDARD_ERROR_OF_MEAN|0.025||0.0004|TWO_SIDED|95.0|0.039|0.138|||Mixed Models Analysis||Difference calculated as Tiotropium + olodaterol 2.5/5 QD minus Olodaterol 5 mcg QD|||0.138|0.039|0.0004
72510795|NCT01533935|144552138|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.097|STANDARD_ERROR_OF_MEAN|0.025||0.0001|TWO_SIDED|95.0|0.047|0.147|||Mixed Models Analysis||Difference calculated as Tiotropium + olodaterol 2.5/5 QD minus Tiotropium 5 mcg QD|||0.147|0.047|0.0001
72510796|NCT01533935|144552139|SUPERIORITY_OR_OTHER||Ratio|1.134|STANDARD_ERROR_OF_MEAN|0.036|<|0.0001|TWO_SIDED|95.0|1.065|1.206|||Mixed Models Analysis||Ratio calculated as Tiotropium + olodaterol 5/5 QD divided by Placebo QD|||1.206|1.065|<0.0001
72510797|NCT01533935|144552139|SUPERIORITY_OR_OTHER||Ratio|1.111|STANDARD_ERROR_OF_MEAN|0.035||0.0009|TWO_SIDED|95.0|1.045|1.182|||Mixed Models Analysis||Ratio calculated Tiotropium + olodaterol 5/5 QD as divided by Olodaterol 5 mcg QD|||1.182|1.045|0.0009
72510798|NCT01533935|144552139|SUPERIORITY_OR_OTHER||Ratio|1.043|STANDARD_ERROR_OF_MEAN|0.033||0.1807|TWO_SIDED|95.0|0.981|1.109|||Mixed Models Analysis||Ratio calculated as Tiotropium + olodaterol 5/5 QD divided by Tiotropium 5 mcg QD|||1.109|0.981|0.1807
72510799|NCT01533935|144552139|SUPERIORITY_OR_OTHER||Ratio|1.121|STANDARD_ERROR_OF_MEAN|0.036||0.0003|TWO_SIDED|95.0|1.054|1.193|||Mixed Models Analysis||Ratio calculated as Tiotropium + olodaterol 2.5/5 QD divided by Placebo QD|||1.193|1.054|0.0003
72510800|NCT01533935|144552139|SUPERIORITY_OR_OTHER||Ratio|1.099|STANDARD_ERROR_OF_MEAN|0.035||0.0029|TWO_SIDED|95.0|1.033|1.17|||Mixed Models Analysis||Ratio calculated as Tiotropium + olodaterol 2.5/5 QD divided by Olodaterol 5 mcg QD|||1.170|1.033|0.0029
72510801|NCT01533935|144552139|SUPERIORITY_OR_OTHER||Ratio|1.032|STANDARD_ERROR_OF_MEAN|0.033||0.324|TWO_SIDED|95.0|0.97|1.098|||Mixed Models Analysis||Ratio calculated as Tiotropium + olodaterol 2.5/5 QD divided by Tiotropium 5 mcg QD|||1.098|0.970|0.3240
72510802|NCT01533935|144552140|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.003|STANDARD_ERROR_OF_MEAN|0.001|<|0.0001|TWO_SIDED|95.0|-0.004|-0.002|||Mixed Models Analysis||Difference calculated as Tiotropium + olodaterol 5/5 QD minus Placebo QD|||-0.002|-0.004|<0.0001
72510803|NCT01533935|144552140|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.002|STANDARD_ERROR_OF_MEAN|0.001||0.0033|TWO_SIDED|95.0|-0.003|-0.001|||Mixed Models Analysis||Difference calculated as Tiotropium + olodaterol 5/5 QD minus Olodaterol 5 mcg QD|||-0.001|-0.003|0.0033
72510804|NCT01533935|144552140|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.001|STANDARD_ERROR_OF_MEAN|0.001||0.2306|TWO_SIDED|95.0|-0.002|0.001|||Mixed Models Analysis||Difference calculated as Tiotropium + olodaterol 5/5 QD minus Tiotropium 5 mcg QD|||0.001|-0.002|0.2306
72510805|NCT01533935|144552140|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.003|STANDARD_ERROR_OF_MEAN|0.001|<|0.0001|TWO_SIDED|95.0|-0.005|-0.002|||Mixed Models Analysis||Difference calculated as Tiotropium + olodaterol 2.5/5 QD minus Placebo QD|||-0.002|-0.005|<0.0001
72510806|NCT01533935|144552140|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.002|STANDARD_ERROR_OF_MEAN|0.001||0.001|TWO_SIDED|95.0|-0.004|-0.001|||Mixed Models Analysis||Difference calculated as Tiotropium + olodaterol 2.5/5 QD minus Olodaterol 5 mcg QD|||-0.001|-0.004|0.0010
72510807|NCT01533935|144552140|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.001|STANDARD_ERROR_OF_MEAN|0.001||0.1206|TWO_SIDED|95.0|-0.002|0.0|||Mixed Models Analysis||Difference calculated as Tiotropium + olodaterol 2.5/5 QD minus Tiotropium 5 mcg QD|||0.000|-0.002|0.1206
72510808|NCT01533935|144552141|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.329|STANDARD_ERROR_OF_MEAN|0.018|<|0.0001|TWO_SIDED|95.0|0.294|0.364|||Mixed Models Analysis||Difference calculated as Tiotropium + olodaterol 5/5 QD minus Placebo QD|||0.364|0.294|<0.0001
72510809|NCT01533935|144552141|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.134|STANDARD_ERROR_OF_MEAN|0.018|<|0.0001|TWO_SIDED|95.0|0.099|0.169|||Mixed Models Analysis||Difference calculated as Tiotropium + olodaterol 5/5 QD minus Olodaterol 5 mcg QD|||0.169|0.099|<0.0001
72510810|NCT01533935|144552141|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.135|STANDARD_ERROR_OF_MEAN|0.018|<|0.0001|TWO_SIDED|95.0|0.1|0.17|||Mixed Models Analysis||Difference calculated as Tiotropium + olodaterol 5/5 QD minus Tiotropium 5 mcg QD|||0.170|0.100|<0.0001
72510811|NCT01533935|144552141|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.305|STANDARD_ERROR_OF_MEAN|0.018|<|0.0001|TWO_SIDED|95.0|0.269|0.34|||Mixed Models Analysis||Difference calculated as Tiotropium + olodaterol 2.5/5 QD minus Placebo QD|||0.340|0.269|<0.0001
72510812|NCT01533935|144552141|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.11|STANDARD_ERROR_OF_MEAN|0.018|<|0.0001|TWO_SIDED|95.0|0.075|0.145|||Mixed Models Analysis||Difference calculated as Tiotropium + olodaterol 2.5/5 QD minus Olodaterol 5 mcg QD|||0.145|0.075|<0.0001
72510813|NCT01533935|144552141|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.111|STANDARD_ERROR_OF_MEAN|0.018|<|0.0001|TWO_SIDED|95.0|0.076|0.146|||Mixed Models Analysis||Difference calculated as Tiotropium + olodaterol 2.5/5 QD minus Tiotropium 5 mcg QD|||0.146|0.076|<0.0001
72510814|NCT00681538|144552182|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|-0.84||||0.0002|TWO_SIDED|95.0|-1.29|-0.4|||ANCOVA|||||-0.40|-1.29|0.0002
72510815|NCT00681538|144552183|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.731||||0.0003|TWO_SIDED|95.0|1.589|4.694|||Regression, Logistic||Odds ratio\>1 indicates an improvement in favour of Sativex|30% responders||4.694|1.589|0.0003
72510816|NCT00681538|144552183|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.647||||0.0612|TWO_SIDED|95.0|0.977|2.777|||Regression, Logistic||Odds ratio\>1 indicates an improvement in favour of Sativex|50% Responders||2.777|0.977|0.0612
72510817|NCT00681538|144552184|SUPERIORITY_OR_OTHER_LEGACY||Treatment difference|-2.53||||0.0046|TWO_SIDED|95.0|-4.27|-0.79|||ANCOVA||A negative difference indicates an improvement in spasm frequency in favour of Sativex.|||-0.79|-4.27|0.0046
72510818|NCT00681538|144552185|SUPERIORITY_OR_OTHER_LEGACY||treatment difference|-0.88|||<|0.0001|TWO_SIDED|95.0|-1.25|-0.51|||ANCOVA||A negative difference indicates an improvement in sleep disruption in favour of Sativex.|||-0.51|-1.25|<0.0001
72510819|NCT00681538|144552186|SUPERIORITY_OR_OTHER_LEGACY||treatment difference|-1.75||||0.0939|TWO_SIDED|95.0|-3.8|0.3|||ANCOVA||A negative difference indicates an improvement in spasticity in favour of Sativex.|||0.30|-3.80|0.0939
72510820|NCT00681538|144552187|SUPERIORITY_OR_OTHER_LEGACY||treatment difference|-2.85||||0.56|TWO_SIDED|95.0|-12.75|7.04|||ANCOVA||A positive treatment difference indicates an improvement in favour of Sativex.|For Arm||7.04|-12.75|0.56
72510821|NCT00681538|144552187|SUPERIORITY_OR_OTHER_LEGACY||Treatment difference|0.04||||0.98|TWO_SIDED|95.0|-2.56|2.64|||ANCOVA||A positive treatment difference indicates an improvement in favour of Sativex.|For leg||2.64|-2.56|0.98
72510822|NCT00681538|144552188|SUPERIORITY_OR_OTHER_LEGACY||Treatment difference|-3.34||||0.0687|TWO_SIDED|95.0|-6.95|0.26|||ANCOVA||A negative treatment difference indicates an improvement in favour of Sativex.|||0.26|-6.95|0.0687
72510823|NCT00681538|144552189|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.703||||0.0234|TWO_SIDED|95.0|1.075|2.698|||Regression, Logistic||An odds ratio \> 1 indicates an improvement in favour of Sativex.|||2.698|1.075|0.0234
72510824|NCT00681538|144552190|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.4||||0.0053|TWO_SIDED|95.0|1.297|4.443|||Regression, Logistic||An odds ratio \> 1 indicates an improvement in favour of Sativex.|||4.443|1.297|0.0053
72510825|NCT00681538|144552191|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.792||||0.0613|TWO_SIDED|95.0|0.973|3.301|||Regression, Logistic||An odds ratio \> 1 indicates an improvement in favour of Sativex.|||3.301|0.973|0.0613
72510826|NCT00681538|144552192|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.958||||0.0045|TWO_SIDED|95.0|1.232|3.112|||Regression, Logistic||An odds ratio \> 1 indicates an improvement in favour of Sativex.|||3.112|1.232|0.0045
72402022|NCT02515942|144311354|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-0.95||||0.6548|TWO_SIDED|80.0|-4.0|2.11|||Mixed Models Analysis|||Change from baseline at Day 197||2.11|-4.00|0.6548
72482201|NCT00568321|144491826|SUPERIORITY||LS Mean Difference|0.44|STANDARD_ERROR_OF_MEAN|0.71||0.733|TWO_SIDED|90.0|-0.73|1.6|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 12 (GA): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.60|-0.73|0.733
72482202|NCT00568321|144491826|SUPERIORITY||LS Mean Difference|-0.32|STANDARD_ERROR_OF_MEAN|0.61||0.303|TWO_SIDED|90.0|-1.33|0.69|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 12 (NW): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.69|-1.33|0.303
72482203|NCT00568321|144491826|SUPERIORITY||LS Mean Difference|0.08|STANDARD_ERROR_OF_MEAN|0.63||0.548|TWO_SIDED|90.0|-0.97|1.12|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 12 (NW): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.12|-0.97|0.548
72482204|NCT00568321|144491826|SUPERIORITY||LS Mean Difference|0.15|STANDARD_ERROR_OF_MEAN|0.56||0.609|TWO_SIDED|90.0|-0.77|1.08|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 16 (CS): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.08|-0.77|0.609
72482205|NCT00568321|144491826|SUPERIORITY||LS Mean Difference|0.13|STANDARD_ERROR_OF_MEAN|0.59||0.59|TWO_SIDED|90.0|-0.83|1.1|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 16 (CS): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.10|-0.83|0.590
72510827|NCT00681538|144552193|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|0.02||||0.2836|TWO_SIDED|95.0|-0.02|0.07|||ANCOVA||A positive difference indicates an improvement in favour of Sativex.|For Health State Index||0.07|-0.02|0.2836
72510828|NCT00681538|144552193|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|1.24||||0.5644|TWO_SIDED|95.0|-3.01|5.5|||ANCOVA||A positive difference indicates an improvement in favour of Sativex.|Health Status VAS||5.50|-3.01|0.5644
72510829|NCT00681538|144552194|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|-0.06||||0.9369|TWO_SIDED|95.0|-1.62|1.49|||ANCOVA||A negative difference indicates an improvement in depression in favour of Sativex.|||1.49|-1.62|0.9369
72510830|NCT00630812|144552195|SUPERIORITY||Mean Difference (Net)|54.14||||0.059|TWO_SIDED|95.0|-1.97|110.26|||Mixed Models Analysis|||||110.26|-1.97|0.059
72510831|NCT00630812|144552195|SUPERIORITY||Odds Ratio (OR)|1.69||||0.041|TWO_SIDED|95.0|1.02|2.8||Response defined as change of \>=100mL at week 26|Regression, Logistic|45.7% response on Mannitol 400mg, 35.5% on Control||||2.80|1.02|0.041
72510832|NCT00630812|144552196|SUPERIORITY||Mean Difference (Net)|43.49||||0.177|TWO_SIDED|95.0|-19.8|106.78|||Mixed Models Analysis|||||106.78|-19.8|0.177
72510833|NCT00630812|144552197|SUPERIORITY||Rate ratio|0.85||||0.52|TWO_SIDED|95.0|0.51|1.41|||Poisson regression|Offset of the natural logarithm of follow-up time||||1.41|0.51|0.520
72510834|NCT00630812|144552198|SUPERIORITY||Rate ratio|0.75||||0.328|TWO_SIDED|95.0|0.42|1.33|||Poisson regression|Offset of the natural logarithm of follow-up time||||1.33|0.42|0.328
72510835|NCT00630812|144552199|SUPERIORITY||Rate ratio|0.89||||0.368|TWO_SIDED|95.0|0.69|1.15|||Poisson regression|||||1.15|0.69|0.368
72510836|NCT00630812|144552200|SUPERIORITY||Mean Difference (Net)|2.42||||0.024|TWO_SIDED|95.0|0.33|4.51|||ANCOVA|||||4.51|0.33|0.024
72510837|NCT00630812|144552201|SUPERIORITY||Mean Difference (Net)|71.35||||0.022|TWO_SIDED|95.0|10.57|132.13|||Mixed Models Analysis|||||132.13|10.57|0.022
72510838|NCT00630812|144552202|SUPERIORITY||Mean Difference (Net)|34.34||||0.49|TWO_SIDED|95.0|-63.47|132.14|||Mixed Models Analysis|||||132.14|-63.47|0.49
72510839|NCT00630812|144552203|SUPERIORITY|||||||0.042|||||||Wilcoxon (Mann-Whitney)|||||||0.042
72510840|NCT01219959|144552204|SUPERIORITY||Mean Difference (Final Values)|0.6|||<|0.001|TWO_SIDED|95.0|0.2|0.9|||ANOVA|||Month 3||0.9|0.2|<0.001
72510841|NCT01219959|144552204|SUPERIORITY||Mean Difference (Final Values)|0.5||||0.006|TWO_SIDED|95.0|0.1|0.8|||ANOVA|||Month 6||0.8|0.1|0.006
72510842|NCT01219959|144552205|SUPERIORITY||Mean Difference (Final Values)|5.0||||0.312|TWO_SIDED|95.0|-4.7|14.7|||ANOVA|||Insulin-Month 3||14.7|-4.7|0.312
72510843|NCT01219959|144552205|SUPERIORITY||Mean Difference (Final Values)|4.7||||0.342|TWO_SIDED|95.0|-5.0|14.4|||ANOVA|||Insulin-Month 6||14.4|-5.0|0.342
72510844|NCT01219959|144552207|SUPERIORITY||Mean Difference (Final Values)|0.5||||0.01|TWO_SIDED|95.0|0.1|0.9|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Cholesterol-Month 3||0.9|0.1|0.010
72510845|NCT01219959|144552207|SUPERIORITY||Median Difference (Final Values)|0.3||||0.073|TWO_SIDED|95.0|0.0|0.7|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Cholesterol-Month 6||0.7|0|0.073
72510846|NCT01219959|144552207|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.181|TWO_SIDED|95.0|-0.1|0.5|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for LDLC-Month 3||0.5|-0.1|0.181
72510847|NCT01219959|144552207|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.593|TWO_SIDED|95.0|-0.2|0.4|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for LDLC-Month 6||0.4|-0.2|0.593
72510848|NCT01219959|144552207|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.198|TWO_SIDED|95.0|-0.2|0.0|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for HDLC-Month 3||0|-0.2|0.198
72510849|NCT01219959|144552207|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.298|TWO_SIDED|95.0|-0.1|0.0|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for HDLC-Month 6||0|-0.1|0.298
72510850|NCT01219959|144552207|SUPERIORITY||Mean Difference (Final Values)|0.4|||<|0.001|TWO_SIDED|95.0|0.2|0.6|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for VLDL-Month 3||0.6|0.2|<0.001
72402023|NCT02515942|144311354|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-0.35||||0.5533|TWO_SIDED|80.0|-3.76|3.05|||Mixed Models Analysis|||Change from baseline at Day 225||3.05|-3.76|0.5533
72402024|NCT02515942|144311354|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|1.11||||0.3358|TWO_SIDED|80.0|-2.25|4.46|||Mixed Models Analysis|||Change from baseline at Day 225||4.46|-2.25|0.3358
72482206|NCT00568321|144491826|SUPERIORITY||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.71||0.556|TWO_SIDED|90.0|-1.07|1.27|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 16 (GA): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.27|-1.07|0.556
72402025|NCT02515942|144311354|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|1.46||||0.285|TWO_SIDED|80.0|-1.85|4.77|||Mixed Models Analysis|||Change from baseline at Day 225||4.77|-1.85|0.2850
72402026|NCT02515942|144311354|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-0.55||||0.5778|TWO_SIDED|80.0|-4.14|3.04|||Mixed Models Analysis|||Change from baseline at Day 253||3.04|-4.14|0.5778
72482207|NCT00568321|144491826|SUPERIORITY||LS Mean Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.73||0.443|TWO_SIDED|90.0|-1.32|1.11|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 16 (GA): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.11|-1.32|0.443
72482208|NCT00568321|144491826|SUPERIORITY||LS Mean Difference|0.04|STANDARD_ERROR_OF_MEAN|0.62||0.527|TWO_SIDED|90.0|-0.99|1.07|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 16 (NW): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.07|-0.99|0.527
72482209|NCT00568321|144491826|SUPERIORITY||LS Mean Difference|0.14|STANDARD_ERROR_OF_MEAN|0.66||0.583|TWO_SIDED|90.0|-0.95|1.22|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 16 (NW): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.22|-0.95|0.583
72510851|NCT01219959|144552207|SUPERIORITY||Mean Difference (Final Values)|0.3||||0.003|TWO_SIDED|95.0|0.1|0.5|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for VLDL-Month 6||0.5|0.1|0.003
72510852|NCT01219959|144552207|SUPERIORITY||Mean Difference (Final Values)|0.8|||<|0.001|TWO_SIDED|95.0|0.4|1.3|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Triglycerides-Month 3||1.3|0.4|<0.001
72510853|NCT01219959|144552207|SUPERIORITY||Mean Difference (Final Values)|0.7||||0.002|TWO_SIDED|95.0|0.3|1.1|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Triglycerides-Month 6||1.1|0.3|0.002
72510854|NCT01219959|144552208|SUPERIORITY||Mean Difference (Final Values)|-2.3||||0.485|TWO_SIDED|95.0|-8.6|4.1|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Lp(a)-Month 3||4.1|-8.6|0.485
72510855|NCT01219959|144552208|SUPERIORITY||Mean Difference (Final Values)|-1.9||||0.556|TWO_SIDED|95.0|-8.2|4.4|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Lp(a)-Month 6||4.4|-8.2|0.556
72510856|NCT01219959|144552208|SUPERIORITY||Mean Difference (Final Values)|5.6||||0.101|TWO_SIDED|95.0|-1.1|12.2|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Apo A1-Month 3||12.2|-1.1|0.101
72510857|NCT01219959|144552208|SUPERIORITY||Mean Difference (Final Values)|5.0||||0.134|TWO_SIDED|95.0|-1.5|11.5|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Apo A1-Month 6||11.5|-1.5|0.134
72510858|NCT01219959|144552208|SUPERIORITY||Mean Difference (Final Values)|11.4||||0.004|TWO_SIDED|95.0|3.6|19.2|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Apo B-Month 3||19.2|3.6|0.004
72510859|NCT01219959|144552208|SUPERIORITY||Mean Difference (Final Values)|8.4||||0.03|TWO_SIDED|95.0|0.8|15.9|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Apo B-Month 6||15.9|0.8|0.030
72510860|NCT01219959|144552209|SUPERIORITY||Mean Difference (Final Values)|-56.5||||0.655|TWO_SIDED|95.0|-304.6|191.7|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Insulin-Month 3||191.7|-304.6|0.655
72510861|NCT01219959|144552209|SUPERIORITY||Mean Difference (Final Values)|-29.2||||0.811|TWO_SIDED|95.0|-268.9|210.5|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Insulin-Month 6||210.5|-268.9|0.811
72510862|NCT01219959|144552209|SUPERIORITY||Mean Difference (Final Values)|441.3||||0.419|TWO_SIDED|95.0|-630.4|1513.1|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for C-Peptide-Month 3||1513.1|-630.4|0.419
72510863|NCT01219959|144552209|SUPERIORITY||Mean Difference (Final Values)|121.8||||0.82|TWO_SIDED|95.0|-927.9|1171.5|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for C-Peptide-Month 6||1171.5|-927.9|0.820
72510864|NCT01219959|144552210|SUPERIORITY||Mean Difference (Final Values)|-4.2||||0.721|TWO_SIDED|95.0|-27.5|19.0|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Pro-Insulin-Month 3||19|-27.5|0.721
72510865|NCT01219959|144552210|SUPERIORITY||Mean Difference (Final Values)|13.5||||0.247|TWO_SIDED|95.0|-9.4|36.4|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Pro-Insulin-Month 6||36.4|-9.4|0.247
72510866|NCT01219959|144552211|SUPERIORITY||Mean Difference (Final Values)|0.89||||0.624|TWO_SIDED|95.0|0.55|1.43|||ANOVA|||Estimates of Ratio-Month 6||1.43|0.55|0.624
72510867|NCT01219959|144552212|SUPERIORITY||Mean Difference (Final Values)|0.6||||0.338|TWO_SIDED|95.0|-0.6|1.8|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Albumin-Month 3||1.8|-0.6|0.338
72510868|NCT01219959|144552212|SUPERIORITY||Mean Difference (Final Values)|1.3||||0.029|TWO_SIDED|95.0|0.1|2.5|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Albumin-Month 6||2.5|0.1|0.029
72510869|NCT01219959|144552212|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.817|TWO_SIDED|95.0|-1.9|1.5|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Total Protein-Month 3||1.5|-1.9|0.817
72402027|NCT02515942|144311354|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|2.3||||0.2018|TWO_SIDED|80.0|-1.24|5.85|||Mixed Models Analysis|||Change from baseline at Day 253||5.85|-1.24|0.2018
72510870|NCT01219959|144552212|SUPERIORITY||Mean Difference (Final Values)|1.4||||0.091|TWO_SIDED|95.0|-0.2|2.9|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Total Protein-Month 6||2.9|-0.2|0.091
72510871|NCT01219959|144552213|SUPERIORITY||Mean Difference (Final Values)|-10.2||||0.127|TWO_SIDED|95.0|-23.3|2.9|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for PNA-Month 3||2.9|-23.3|0.127
72402028|NCT02515942|144311354|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|2.85||||0.1457|TWO_SIDED|80.0|-0.62|6.32|||Mixed Models Analysis|||Change from baseline at Day 253||6.32|-0.62|0.1457
72510872|NCT01219959|144552213|SUPERIORITY||Mean Difference (Final Values)|-10.3|||<|0.001|TWO_SIDED|95.0|-16.4|-4.3|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for PNA-Month 6||-4.3|-16.4|<0.001
72510873|NCT01219959|144552213|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.012|TWO_SIDED|95.0|-0.4|-0.1|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for nPNA-Month 3||-0.1|-0.4|0.012
72566909|NCT02654587|144664494|SUPERIORITY||P Value|0.0003||||0.0003|TWO_SIDED||||||Mixed Models Analysis|||QLQ-C30 Constipation in ICI secondary resistance||||0.0003
72510874|NCT01219959|144552213|SUPERIORITY||Mean Difference (Final Values)|-0.2|||<|0.001|TWO_SIDED|95.0|-0.3|-0.1|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for nPNA-Month 6||-0.1|-0.3|<0.001
72510875|NCT01219959|144552214|SUPERIORITY||Mean Difference (Final Values)|3.2||||0.019|TWO_SIDED|95.0|0.5|5.8|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Pre-Albumin-Month 3||5.8|0.5|0.019
72510876|NCT01219959|144552214|SUPERIORITY||Mean Difference (Final Values)|3.0||||0.019|TWO_SIDED|95.0|0.5|5.6|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Pre-Albumin-Month 6||5.6|0.5|0.019
72510877|NCT01219959|144552215|SUPERIORITY||Mean Difference (Final Values)|-0.3||||0.884|TWO_SIDED|95.0|-3.9|3.4|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Drained Fat-Month 3||3.4|-3.9|0.884
72510878|NCT01219959|144552215|SUPERIORITY||Mean Difference (Final Values)|0.7||||0.716|TWO_SIDED|95.0|-3.0|4.3|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Drained Fat-Month 6||4.3|-3|0.716
72566910|NCT02654587|144664494|SUPERIORITY||P Value|0.8||||0.8|TWO_SIDED||||||Mixed Models Analysis|||QLQ-C30 Dyspnea in ICI secondary resistance||||0.80
72566911|NCT02654587|144664494|SUPERIORITY||P Value|0.21||||0.21|TWO_SIDED||||||Mixed Models Analysis|||QLQ-C30 Nausea and Vomiting in ICI secondary resistance||||0.21
72510879|NCT01219959|144552216|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.961|TWO_SIDED|95.0|-1.2|1.1|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for BMI-Month 3||1.1|-1.2|0.961
72510880|NCT01219959|144552216|SUPERIORITY||Mean Difference (Final Values)|0.3||||0.581|TWO_SIDED|95.0|-0.8|1.5|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for BMI-Month 6||1.5|-0.8|0.581
72510881|NCT01219959|144552217|SUPERIORITY||Mean Difference (Final Values)|-0.3||||0.871|TWO_SIDED|95.0|-3.7|3.1|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Waist Circumference-Month 6||3.1|-3.7|0.871
72510882|NCT01219959|144552218|SUPERIORITY||Mean Difference (Final Values)|5.2||||0.608|TWO_SIDED|95.0|-14.7|25.0|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Protein-Month 3||25|-14.7|0.608
72566912|NCT02654587|144664494|SUPERIORITY||P Value|0.45||||0.45|TWO_SIDED||||||Mixed Models Analysis|||QLQ-C30 Pain in ICI secondary resistance||||0.45
72566913|NCT02654587|144664494|SUPERIORITY||P Value|0.87||||0.87|TWO_SIDED||||||Mixed Models Analysis|||QLQ-C30 Insomnia in ICI secondary resistance||||0.87
72566914|NCT02654587|144664494|SUPERIORITY||P Value|0.59||||0.59|TWO_SIDED||||||Mixed Models Analysis|||QLQ-C30 Appetite loss in ICI secondary resistance||||0.59
72566915|NCT02654587|144664494|SUPERIORITY||P Value|0.88||||0.88|TWO_SIDED||||||Mixed Models Analysis|||QLQ-C30 Diarrhea in ICI secondary resistance||||0.88
72566916|NCT02654587|144664494|SUPERIORITY||P Value|0.37||||0.37|TWO_SIDED||||||Mixed Models Analysis|||QLQ-C30 Financial difficulties in ICI secondary resistance||||0.37
72510883|NCT01219959|144552218|SUPERIORITY||Mean Difference (Final Values)|-1.7||||0.731|TWO_SIDED|95.0|-11.5|8.1|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Protein-Month 6||8.1|-11.5|0.731
72510884|NCT01219959|144552218|SUPERIORITY||Mean Difference (Final Values)|185.3||||0.377|TWO_SIDED|95.0|-227.5|598.1|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Calories-Month 3||598.1|-227.5|0.377
72510885|NCT01219959|144552218|SUPERIORITY||Mean Difference (Final Values)|-18.3||||0.854|TWO_SIDED|95.0|-214.4|177.8|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Calories-Month 6||177.8|-214.4|0.854
72510886|NCT01219959|144552219|SUPERIORITY||Mean Difference (Final Values)|0.02||||0.412|TWO_SIDED|95.0|-0.03|0.07|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for EQ 5D Questionnaire Index-Month 3||0.07|-0.03|0.412
72510887|NCT01219959|144552219|SUPERIORITY||Mean Difference (Final Values)|-0.02||||0.485|TWO_SIDED|95.0|-0.07|0.03|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for EQ 5D Questionnaire Index-Month 6||0.03|-0.07|0.485
72510888|NCT01219959|144552220|SUPERIORITY||Mean Difference (Final Values)|2.18||||0.525|TWO_SIDED|95.0|-4.56|8.93|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for EQ 5D Quest Health Status-Month 3||8.93|-4.56|0.525
72482210|NCT00568321|144491829|SUPERIORITY||LS Mean Difference|-0.77|STANDARD_ERROR_OF_MEAN|0.63||0.111|TWO_SIDED|90.0|-1.81|0.27|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 1: LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.27|-1.81|0.111
72482211|NCT00568321|144491829|SUPERIORITY||LS Mean Difference|0.04|STANDARD_ERROR_OF_MEAN|0.64||0.523|TWO_SIDED|90.0|-1.02|1.09|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 1: LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.09|-1.02|0.523
72482212|NCT00568321|144491829|SUPERIORITY||LS Mean Difference|0.77|STANDARD_ERROR_OF_MEAN|0.63||0.887|TWO_SIDED|90.0|-0.28|1.81|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 2: LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.81|-0.28|0.887
72482213|NCT00568321|144491829|SUPERIORITY||LS Mean Difference|0.85|STANDARD_ERROR_OF_MEAN|0.65||0.903|TWO_SIDED|90.0|-0.23|1.92|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 2: LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.92|-0.23|0.903
72482214|NCT00568321|144491829|SUPERIORITY||LS Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.64||0.472|TWO_SIDED|90.0|-1.11|1.02|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 4: LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.02|-1.11|0.472
72482215|NCT00568321|144491829|SUPERIORITY||LS Mean Difference|0.22|STANDARD_ERROR_OF_MEAN|0.66||0.628|TWO_SIDED|90.0|-0.87|1.3|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 4: LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.30|-0.87|0.628
72482216|NCT00568321|144491829|SUPERIORITY||LS Mean Difference|-0.47|STANDARD_ERROR_OF_MEAN|0.67||0.243|TWO_SIDED|90.0|-1.58|0.64|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 6: LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.64|-1.58|0.243
72482217|NCT00568321|144491829|SUPERIORITY||LS Mean Difference|-0.27|STANDARD_ERROR_OF_MEAN|0.69||0.346|TWO_SIDED|90.0|-1.42|0.87|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 6: LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.87|-1.42|0.346
72482218|NCT00568321|144491829|SUPERIORITY||LS Mean Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.69||0.467|TWO_SIDED|90.0|-1.19|1.08|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 8: LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.08|-1.19|0.467
72482219|NCT00568321|144491829|SUPERIORITY||LS Mean Difference|0.31|STANDARD_ERROR_OF_MEAN|0.7||0.67|TWO_SIDED|90.0|-0.85|1.47|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 8: LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.47|-0.85|0.670
72482220|NCT00568321|144491829|SUPERIORITY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.7||0.286|TWO_SIDED|90.0|-1.55|0.76|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 12: LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.76|-1.55|0.286
72482221|NCT00568321|144491829|SUPERIORITY||LS Mean Difference|0.18|STANDARD_ERROR_OF_MEAN|0.71||0.598|TWO_SIDED|90.0|-1.0|1.35|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 12: LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.35|-1.00|0.598
72482222|NCT00568321|144491829|SUPERIORITY||LS Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.71||0.453|TWO_SIDED|90.0|-1.26|1.09|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 16: LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.09|-1.26|0.453
72482223|NCT00568321|144491829|SUPERIORITY||LS Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.74||0.472|TWO_SIDED|90.0|-1.28|1.17|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 16: LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.17|-1.28|0.472
72510889|NCT01219959|144552220|SUPERIORITY||Mean Difference (Final Values)|0.02||||0.995|TWO_SIDED|95.0|-6.79|6.83|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for EQ 5D Quest Health Status-Month 6||6.83|-6.79|0.995
72510890|NCT01219959|144552221|SUPERIORITY||Mean Difference (Final Values)|-1.87||||0.526|TWO_SIDED|95.0|-7.64|3.91|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Psychology Fatigue-Month 3||3.91|-7.64|0.526
72510891|NCT01219959|144552221|SUPERIORITY||Mean Difference (Final Values)|0.83||||0.779|TWO_SIDED|95.0|-5.01|6.68|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Psychology Fatigue-Month 6||6.68|-5.01|0.779
72510892|NCT01219959|144552221|SUPERIORITY||Mean Difference (Final Values)|-2.95||||0.246|TWO_SIDED|95.0|-7.95|2.04|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Psychology Cognitive-Month 3||2.04|-7.95|0.246
72402029|NCT02515942|144311354|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-0.56||||0.5758|TWO_SIDED|80.0|-4.29|3.18|||Mixed Models Analysis|||Change from baseline at Day 281||3.18|-4.29|0.5758
72402030|NCT02515942|144311354|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|0.85||||0.3833|TWO_SIDED|80.0|-2.84|4.55|||Mixed Models Analysis|||Change from baseline at Day 281||4.55|-2.84|0.3833
72482224|NCT00568321|144491843|SUPERIORITY||LS Mean Difference|-0.12|STANDARD_ERROR_OF_MEAN|1.02||0.548|TWO_SIDED|90.0|-1.81|1.56|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 2 (Learning): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.56|-1.81|0.548
72402031|NCT02515942|144311354|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|1.41||||0.3083|TWO_SIDED|80.0|-2.21|5.02|||Mixed Models Analysis|||Change from baseline at Day 281||5.02|-2.21|0.3083
72402032|NCT02515942|144311354|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-1.54||||0.7063|TWO_SIDED|80.0|-5.19|2.11|||Mixed Models Analysis|||Change from baseline at Day 309||2.11|-5.19|0.7063
72402033|NCT02515942|144311354|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|2.14||||0.2227|TWO_SIDED|80.0|-1.46|5.74|||Mixed Models Analysis|||Change from baseline at Day 309||5.74|-1.46|0.2227
72482225|NCT00568321|144491843|SUPERIORITY||LS Mean Difference|1.24|STANDARD_ERROR_OF_MEAN|1.04||0.117|TWO_SIDED|90.0|-0.48|2.96|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 2 (Learning): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||2.96|-0.48|0.117
72510893|NCT01219959|144552221|SUPERIORITY||Mean Difference (Final Values)|-0.72||||0.78|TWO_SIDED|95.0|-5.78|4.34|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Psychology Cognitive-Month 6||4.34|-5.78|0.780
72402034|NCT02515942|144311354|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|3.68||||0.0907|TWO_SIDED|80.0|0.15|7.21|||Mixed Models Analysis|||Change from baseline at Day 309||7.21|0.15|0.0907
72402035|NCT02515942|144311354|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|0.17||||0.4799|TWO_SIDED|80.0|-4.23|4.57|||Mixed Models Analysis|||Change from baseline at Day 337||4.57|-4.23|0.4799
72482226|NCT00568321|144491843|SUPERIORITY||LS Mean Difference|-0.86|STANDARD_ERROR_OF_MEAN|1.11||0.779|TWO_SIDED|90.0|-2.69|0.98|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 6 (Learning): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.98|-2.69|0.779
72482227|NCT00568321|144491843|SUPERIORITY||LS Mean Difference|0.36|STANDARD_ERROR_OF_MEAN|1.14||0.375|TWO_SIDED|90.0|-1.52|2.25|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 6 (Learning): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||2.25|-1.52|0.375
72510894|NCT01219959|144552221|SUPERIORITY||Mean Difference (Final Values)|0.41||||0.885|TWO_SIDED|95.0|-5.22|6.04|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Neurology Pain-Month 3||6.04|-5.22|0.885
72510895|NCT01219959|144552221|SUPERIORITY||Mean Difference (Final Values)|4.41||||0.128|TWO_SIDED|95.0|-1.28|10.1|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Neurology Pain-Month 6||10.10|-1.28|0.128
72510896|NCT01219959|144552221|SUPERIORITY||Mean Difference (Final Values)|1.07||||0.701|TWO_SIDED|95.0|-4.4|6.54|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Neurology Sensory-Month 3||6.54|-4.40|0.701
72510897|NCT01219959|144552221|SUPERIORITY||Mean Difference (Final Values)|7.21||||0.01|TWO_SIDED|95.0|1.7|12.73|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Neurology Sensory-Month 6||12.73|1.70|0.010
72510898|NCT01219959|144552221|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.934|TWO_SIDED|95.0|-4.63|5.03|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Cardiology-Month 3||5.03|-4.63|0.934
72510899|NCT01219959|144552221|SUPERIORITY||Mean Difference (Final Values)|3.13||||0.209|TWO_SIDED|95.0|-1.75|8.01|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Cardiology-Month 6||8.01|-1.75|0.209
72510900|NCT01219959|144552221|SUPERIORITY||Mean Difference (Final Values)|1.89||||0.585|TWO_SIDED|95.0|-4.9|8.68|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Ophthalmology-Month 3||8.68|-4.90|0.585
72566917|NCT02654587|144664495|SUPERIORITY||P Value|0.0001|||<|0.0001|TWO_SIDED||||||Mixed Models Analysis|||QLQ-LC13 Alopecia in ICI secondary resistance||||<0.0001
72482228|NCT00568321|144491843|SUPERIORITY||LS Mean Difference|-1.36|STANDARD_ERROR_OF_MEAN|1.15||0.881|TWO_SIDED|90.0|-3.26|0.54|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 12 (Learning): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.54|-3.26|0.881
72482229|NCT00568321|144491843|SUPERIORITY||LS Mean Difference|-0.41|STANDARD_ERROR_OF_MEAN|1.17||0.636|TWO_SIDED|90.0|-2.33|1.52|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 12 (Learning): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.52|-2.33|0.636
72482230|NCT00568321|144491843|SUPERIORITY||LS Mean Difference|-1.54|STANDARD_ERROR_OF_MEAN|1.17||0.905|TWO_SIDED|90.0|-3.46|0.39|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 16 (Learning): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.39|-3.46|0.905
72482231|NCT00568321|144491843|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|1.21||0.499|TWO_SIDED|90.0|-2.0|2.0|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 16 (Learning): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||2.00|-2.00|0.499
72482232|NCT00568321|144491843|SUPERIORITY||LS Mean Difference|0.27|STANDARD_ERROR_OF_MEAN|0.5||0.297|TWO_SIDED|90.0|-0.56|1.09|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 2 (Delayed): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.09|-0.56|0.297
72482233|NCT00568321|144491843|SUPERIORITY||LS Mean Difference|0.91|STANDARD_ERROR_OF_MEAN|0.5||0.035|TWO_SIDED|90.0|0.09|1.74|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 2 (Delayed): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.74|0.09|0.035
72482234|NCT00568321|144491843|SUPERIORITY||LS Mean Difference|0.41|STANDARD_ERROR_OF_MEAN|0.54||0.222|TWO_SIDED|90.0|-0.48|1.31|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 6 (Delayed): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.31|-0.48|0.222
72482235|NCT00568321|144491843|SUPERIORITY||LS Mean Difference|0.81|STANDARD_ERROR_OF_MEAN|0.54||0.069|TWO_SIDED|90.0|-0.09|1.7|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 6 (Delayed): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.70|-0.09|0.069
72482236|NCT00568321|144491843|SUPERIORITY||LS Mean Difference|0.23|STANDARD_ERROR_OF_MEAN|0.55||0.338|TWO_SIDED|90.0|-0.68|1.15|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 12 (Delayed): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.15|-0.68|0.338
72482237|NCT00568321|144491843|SUPERIORITY||LS Mean Difference|0.17|STANDARD_ERROR_OF_MEAN|0.56||0.381|TWO_SIDED|90.0|-0.75|1.09|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 12 (Delayed): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.09|-0.75|0.381
72482238|NCT00568321|144491843|SUPERIORITY||LS Mean Difference|0.29|STANDARD_ERROR_OF_MEAN|0.56||0.306|TWO_SIDED|90.0|-0.64|1.21|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 16 (Delayed): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.21|-0.64|0.306
72482239|NCT00568321|144491843|SUPERIORITY||LS Mean Difference|0.09|STANDARD_ERROR_OF_MEAN|0.58||0.44|TWO_SIDED|90.0|-0.87|1.04|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 16 (Delayed): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.04|-0.87|0.440
72482240|NCT00221195|144491850|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||Wilcoxon (Mann-Whitney)|||The Wilcoxin signed-rank test was used to compare the frequency of bleeds between the prophylaxis and on-demand periods.||||<0.001
72482241|NCT01369511|144491851|SUPERIORITY_OR_OTHER|||||||0.527|TWO_SIDED|||||p-values are from type 3 tests.|Mixed Models Analysis|||at Week 12||||0.527
72482242|NCT01369511|144491851|SUPERIORITY_OR_OTHER|||||||0.291|TWO_SIDED|||||p-values are from type 3 tests.|Mixed Models Analysis|||at Week 12||||0.291
72482243|NCT01369511|144491851|SUPERIORITY_OR_OTHER|||||||0.129|TWO_SIDED|||||p-values are from type 3 tests.|Mixed Models Analysis|||at Week 12||||0.129
72566918|NCT02654587|144664495|SUPERIORITY||P Value|0.03||||0.03|TWO_SIDED||||||Mixed Models Analysis|||QLQ-LC 13 Peripheral neuropathy in ICI secondary resistance||||0.03
72566919|NCT02654587|144664495|SUPERIORITY||P Value|0.01||||0.01|TWO_SIDED||||||Mixed Models Analysis|||QLQ-LC13 Sore mouth in ICI secondary resistance||||0.01
72566920|NCT02654587|144664495|SUPERIORITY||P Value|0.01||||0.01|TWO_SIDED||||||Mixed Models Analysis|||QLQ-LC13 Dysphagia in ICI secondary resistance||||0.01
72566921|NCT02654587|144664495|SUPERIORITY||P Value|0.35||||0.35|TWO_SIDED||||||Mixed Models Analysis|||QLQ-LC13 Pain in arm and shoulder||||0.35
72566922|NCT02654587|144664495|SUPERIORITY||P Value|0.43||||0.43|TWO_SIDED||||||Mantel Haenszel|||QLQ-LC13 Pain in chest in ICI secondary resistance||||0.43
72566923|NCT02654587|144664495|SUPERIORITY||P Value|0.78||||0.78|TWO_SIDED||||||Mixed Models Analysis|||QLQ-LC13 Pain in other parts||||0.78
72402036|NCT02515942|144311354|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-0.2||||0.5237|TWO_SIDED|80.0|-4.54|4.14|||Mixed Models Analysis|||Change from baseline at Day 337||4.14|-4.54|0.5237
72624018|NCT02231580|144778427|SUPERIORITY_OR_OTHER||GLS mean ratio|1.18|||=|0.6431|TWO_SIDED|90.0|0.644|2.162|||MMRM|||Right hand ITI variability statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||2.162|0.644|=0.6431
72402037|NCT02515942|144311354|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-0.37||||0.5451|TWO_SIDED|80.0|-4.62|3.87|||Mixed Models Analysis|||Change from baseline at Day 337||3.87|-4.62|0.5451
72402038|NCT02515942|144311355|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|0.15||||0.4609|TWO_SIDED|80.0|-1.79|2.09|||Mixed Models Analysis|||Change from baseline at Day 2||2.09|-1.79|0.4609
72402039|NCT02515942|144311355|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|0.46||||0.3771|TWO_SIDED|80.0|-1.44|2.37|||Mixed Models Analysis|||Change from baseline at Day 2||2.37|-1.44|0.3771
72402040|NCT02515942|144311355|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|0.32||||0.4161|TWO_SIDED|80.0|-1.6|2.24|||Mixed Models Analysis|||Change from baseline at Day 2||2.24|-1.60|0.4161
72402041|NCT02515942|144311355|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-2.88||||0.9385|TWO_SIDED|80.0|-5.26|-0.49|||Mixed Models Analysis|||Change from baseline at Day 29||-0.49|-5.26|0.9385
72402042|NCT02515942|144311355|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-0.4||||0.5862|TWO_SIDED|80.0|-2.76|1.96|||Mixed Models Analysis|||Change from baseline at Day 29||1.96|-2.76|0.5862
72482244|NCT01369511|144491852|SUPERIORITY_OR_OTHER|||||||0.751|TWO_SIDED|||||p-values are from type 3 tests.|Mixed Models Analysis|||at Week 8||||0.751
72482245|NCT01369511|144491852|SUPERIORITY_OR_OTHER|||||||0.066|TWO_SIDED|||||p-values are from type 3 tests.|Mixed Models Analysis|||at Week 8||||0.066
72482246|NCT01369511|144491852|SUPERIORITY_OR_OTHER|||||||0.031|TWO_SIDED|||||p-values are from type 3 tests.|Mixed Models Analysis|||at Week 8||||0.031
72482247|NCT01369511|144491852|SUPERIORITY_OR_OTHER|||||||0.315|TWO_SIDED|||||p-values are from type 3 tests.|Mixed Models Analysis|||at Week 16||||0.315
72482248|NCT01369511|144491852|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED|||||p-values are from type 3 tests.|Mixed Models Analysis|||at Week 16||||0.002
72482249|NCT01369511|144491852|SUPERIORITY_OR_OTHER|||||||0.007|TWO_SIDED|||||p-values are from type 3 tests.|Mixed Models Analysis|||at Week 16||||0.007
72566924|NCT02654587|144664495|SUPERIORITY||P Value|0.23||||0.23|TWO_SIDED||||||Mixed Models Analysis|||QLQ-LC 13 Hemoptysis in ICI secondary resistance||||0.23
72566925|NCT02654587|144664495|SUPERIORITY||P Value|0.54||||0.54|TWO_SIDED||||||Mixed Models Analysis|||QLQ-LC13 Coughing in ICI secondary resistance||||0.54
72566926|NCT02654587|144664496|SUPERIORITY||Odds Ratio (OR)|1.09||||0.87|TWO_SIDED|95.0|0.43|2.75|||Mantel Haenszel|||DCR at 6 months in patients with ICI secondary resistance||2.75|0.43|0.87
72566927|NCT02654587|144664496|SUPERIORITY||Odds Ratio (OR)|0.73||||0.37|TWO_SIDED|95.0|0.36|1.46|||Mantel Haenszel|||DCR at 6 months in ITT patients with ICI resistance (primary and secondary)||1.46|0.36|0.37
72482250|NCT01176968|144491859|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|0.581|||<|0.0001|TWO_SIDED|95.0|0.446|0.756||All analyses for primary endpoint were tested at two-sided, α-level of 0.05, without adjusting for multiplicity.|Regression, Cox|||Hazard ratio, 95% confidence interval (CI) of hazard ratio, and p-value for the Primary Analysis based on a Cox proportional hazard model with treatment as the major factor, adjusted for baseline estimated glomerular filtration rate (eGFR), with/without previous MI, time of first dose administered post onset of index symptom, and location of index MI anterior or non-anterior.||0.756|0.446|< 0.0001
72482251|NCT01176968|144491860|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|0.562||||0.6406|TWO_SIDED|95.0|0.05|6.308|||Regression, Cox|||Hazard ratio, 95% CI of hazard ratio, p-value for all secondary endpoints based on Cox proportional hazard model with treatment as the major factor, adjusted for baseline eGFR, with/without previous MI, index MI location, time of first dose administered post onset of index symptom.||6.308|0.050|0.6406
72566928|NCT02654587|144664497|SUPERIORITY||Hazard Ratio (HR)|1.28||||0.29|TWO_SIDED|95.0|0.82|2.0|||t-test, 2 sided|||Median PFS in patients with ICI secondary resistance||2.0|0.82|0.29
72510901|NCT01219959|144552221|SUPERIORITY||Mean Difference (Final Values)|1.62||||0.641|TWO_SIDED|95.0|-5.22|8.47|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Ophthalmology-Month 6||8.47|-5.22|0.641
72624019|NCT02231580|144778427|SUPERIORITY_OR_OTHER||GLS mean ratio|1.193|||=|0.0389|TWO_SIDED|90.0|1.038|1.371|||MMRM|||Left hand ITI duration statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||1.371|1.038|=0.0389
72402043|NCT02515942|144311355|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|2.48||||0.0875|TWO_SIDED|80.0|0.14|4.82|||Mixed Models Analysis|||Change from baseline at Day 29||4.82|0.14|0.0875
72482252|NCT01176968|144491861|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|0.726||||0.5338|TWO_SIDED|95.0|0.265|1.99|||Regression, Cox|||Hazard ratio, 95% CI of hazard ratio, p-value for all secondary endpoints based on Cox proportional hazard model with treatment as a factor, adjusted for baseline eGFR, with/without previous MI, index MI location, time of first dose administered post onset of index symptom.||1.990|0.265|0.5338
72482253|NCT01176968|144491863|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|1.083||||0.8042|TWO_SIDED|95.0|0.575|2.04|||Regression, Cox|||Hazard ratio, 95% CI of hazard ratio, p-value for all secondary endpoints based on Cox proportional hazard model with treatment as the major factor, adjusted for baseline eGFR, with/without previous MI, index MI location, time of first dose administered post onset of index symptom.||2.040|0.575|0.8042
72482254|NCT01176968|144491864|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|0.598||||0.0003|TWO_SIDED|95.0|0.452|0.791|||Regression, Cox|||Hazard ratio, 95% CI of hazard ratio, p-value for all secondary endpoints based on Cox proportional hazard model with treatment as a factor, adjusted for baseline eGFR, with/without previous MI, index MI location, time of first dose administered post onset of index symptom.||0.791|0.452|0.0003
72482255|NCT01176968|144491865|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|1.069||||0.9353|TWO_SIDED|95.0|0.213|5.371|||Regression, Cox|||Hazard ratio, 95% CI of hazard ratio, p-value for all secondary endpoints based on Cox proportional hazard model with treatment as a factor, adjusted for baseline eGFR, with/without previous MI, index MI location, time of first dose administered post onset of index symptom.||5.371|0.213|0.9353
72482256|NCT01176968|144491866|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|1.6||||0.3757|TWO_SIDED|95.0|0.566|4.525|||Regression, Cox|||Hazard ratio, 95% CI of hazard ratio, p-value for all secondary endpoints based on Cox proportional hazard model with treatment as the major factor, adjusted for baseline eGFR, with/without previous MI, index MI location, time of first dose administered post onset of index symptom.||4.525|0.566|0.3757
72482257|NCT01176968|144491867|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.45||||0.1744|TWO_SIDED|95.0|-3.55|0.65|||ANCOVA|||ANCOVA model was used with observed value as the dependent variable, treatment as a major factor, and baseline QRS duration, baseline eGFR, with/without previous MI, time (in hours) of first dose administered post onset of index symptom, and location of index MI (anterior versus all other locations) as covariates.||0.65|-3.55|0.1744
72482258|NCT01176968|144491868|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.02||||0.7123|TWO_SIDED|95.0|-0.1|0.14||ANCOVA was used for between-treatment comparisons of the LSMeans, 95% CI of LSMEANS, LSMeans difference, 95% CI of LSMeans difference, and p-value with observed value at the given time point as variable.|ANCOVA|||For the Between-Treatment difference for Eplerenone and Placebo groups of observed value taken at Month 6 visit, ANCOVA model was performed for LAD based on the LOCF method including treatment groups with/without adjustments for baseline eGFR (in mL/min/1.73 m2), previous MI (yes/no), time (in hours) of first dose administered post-onset of symptom, index MI location (anterior versus all others) as covariates.||0.14|-0.10|0.7123
72482259|NCT01176968|144491868|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.04||||0.4105|TWO_SIDED|95.0|-0.05|0.13||ANCOVA was used for between-treatment comparisons of the LSMeans, 95% CI of LSMEANS, LSMeans difference, 95% CI of LSMeans difference, and p-value with observed value at the given time point as variable.|ANCOVA|||For the Between-Treatment difference for Eplerenone and Placebo groups of observed value taken at Month 6 visit, ANCOVA model was performed for LAD based on the LOCF method including treatment groups with/without adjustments for baseline eGFR (in mL/min/1.73 m2), previous MI (yes/no), time (in hours) of first dose administered post-onset of symptom, index MI location (anterior versus all others) as covariates.||0.13|-0.05|0.4105
72482260|NCT01176968|144491869|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||Signed Rank Test|||For Biomarker- Aldosterone, signed rank test for change from baseline at Month 6 within treatment difference was used to derive p-value.||||< 0.0001
72482261|NCT01176968|144491869|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.5552|TWO_SIDED||||||Signed Rank Test|||For Biomarker- Aldosterone, signed rank test for change from baseline at Month 6 within treatment difference was used to derive p-value.||||< 0.5552
72482262|NCT01176968|144491869|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||Wilcoxon Rank-Sum test|||For Biomarker- Aldosterone, Wilconxon rank-sum test for between treatment difference at Month 6 was used to derive p-value.||||< 0.0001
72482263|NCT01176968|144491869|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||Signed Rank Test|||For Biomarker- Serum Cortisol, signed rank test for change from baseline at Month 6 within treatment difference was used to derive p-value.||||< 0.0001
72482264|NCT01176968|144491869|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||Signed Rank Test|||For Biomarker- Serum Cortisol, signed rank test for change from baseline at Month 6 within treatment difference was used to derive p-value.||||< 0.0001
72482265|NCT01176968|144491869|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3347|TWO_SIDED||||||Wilcoxon Rank-Sum test|||For Biomarker- Serum Cortisol, Wilconxon rank-sum test for between treatment difference at Month 6 was used to derive p-value.||||0.3347
72482266|NCT01176968|144491870|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0005|TWO_SIDED||||||Signed Rank Test|||For Biomarker- PIIINP, signed rank test for change from baseline at Month 6 within treatment difference was used to derive p-value.||||0.0005
72624020|NCT02231580|144778427|SUPERIORITY_OR_OTHER||GLS mean ratio|1.138|||=|0.1641|TWO_SIDED|90.0|0.976|1.327|||MMRM|||Right hand ITI duration statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||1.327|0.976|=0.1641
72510902|NCT01219959|144552221|SUPERIORITY||Mean Difference (Final Values)|-1.5||||0.586|TWO_SIDED|95.0|-6.89|3.9|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Hypoglycemia-Month 3||3.90|-6.89|0.586
72510903|NCT01219959|144552221|SUPERIORITY||Mean Difference (Final Values)|-0.33||||0.906|TWO_SIDED|95.0|-5.79|5.14|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Hypoglycemia-Month 6||5.14|-5.79|0.906
72510904|NCT01219959|144552221|SUPERIORITY||Mean Difference (Final Values)|-0.09||||0.97|TWO_SIDED|95.0|-4.93|4.75|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Hyperglycemia-Month 3||4.75|-4.93|0.970
72510905|NCT01219959|144552221|SUPERIORITY||Mean Difference (Final Values)|2.38||||0.34|TWO_SIDED|95.0|-2.52|7.28|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Hyperglycemia-Month 6||7.28|-2.52|0.340
72624021|NCT02231580|144778428|SUPERIORITY_OR_OTHER||GLS mean ratio|0.93|||=|0.5668|TWO_SIDED|90.0|0.755|1.147|||MMRM|||Left hand TF variability statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||1.147|0.755|=0.5668
72624022|NCT02231580|144778428|SUPERIORITY_OR_OTHER||GLS mean ratio|0.978|||=|0.8686|TWO_SIDED|90.0|0.778|1.229|||MMRM|||Right hand TF variability statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||1.229|0.778|=0.8686
72510906|NCT01219959|144552222|SUPERIORITY||Mean Difference (Final Values)|24.6||||0.495|TWO_SIDED|95.0|-46.9|96.0|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Abdominal Subcutaneous Fat Volume-Month 6||96|-46.9|0.495
72510907|NCT01219959|144552222|SUPERIORITY||Mean Difference (Final Values)|55.4||||0.081|TWO_SIDED|95.0|-7.0|117.8|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Abdominal Visceral Fat Volume-Month 6||117.8|-7|0.081
72510908|NCT01219959|144552223|SUPERIORITY||Mean Difference (Final Values)|6.3||||0.626|TWO_SIDED|95.0|-19.3|31.9|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for LV End Diastolic Volume-Month 6||31.9|-19.3|0.626
72510909|NCT01219959|144552223|SUPERIORITY||Mean Difference (Final Values)|7.8||||0.486|TWO_SIDED|95.0|-14.5|30.1|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for LV End Systolic Volume-Month 6||30.1|-14.5|0.486
72510910|NCT01219959|144552224|SUPERIORITY||Mean Difference (Final Values)|2.3||||0.832|TWO_SIDED|95.0|-18.9|23.4|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for LV Mass with Pap Muscles-Month 6||23.4|-18.9|0.832
72510911|NCT01219959|144552224|SUPERIORITY||Mean Difference (Final Values)|2.4||||0.82|TWO_SIDED|95.0|-18.3|23.1|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for LV Mass without Pap Muscles-Month 6||23.1|-18.3|0.820
72510912|NCT01219959|144552225|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.955|TWO_SIDED|95.0|-6.9|6.5|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for LV Ejection Fraction-Month 6||6.5|-6.9|0.955
72510913|NCT03656926|144552240|SUPERIORITY|Estimates are from a Linear Mixed Model on the response variable change from baseline in FEV1 with factors for time splines, treatment, the interactions of time splines by treatment, baseline FEV1, the interactions of time splines with baseline FEV1, region (North America vs all other countries together), age (\<55 versus \>=55 years), use of azithromycin at randomization, and time as random effect.|least square mean difference|-0.028||||0.6639|TWO_SIDED|95.0|-0.16|0.104||This is a 1-side p value.|Mixed Models Analysis|||V9 - week 48||0.104|-0.160|0.6639
72510914|NCT00436969|144552256|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.472||||0.696|TWO_SIDED|95.0|-8.888|5.943||The a priori threshold for significance was a two-sided p \<0.05.|Mixed Models Repeated Measures ANCOVA|The analysis included baseline score as a covariate. Site was dropped from the model due to statistical insignificance.||Anticipated VAS difference of 10 mm and SD of 25 mm indicated a sample size of 225 subjects in a 2:1 randomization would provide 80% power to detect a significant difference with a two-sided significance level of 5%. To account for a 15% dropout rate the sample size was increased to 270 subjects (180 Orthovisc, 90 control). The primary null hypothesis (Ho) no difference in VAS means at 6 months and the alternative hypothesis (Ha) was that Orthovisc (mean VAS) is superior to the control.||5.943|-8.888|0.696
72510915|NCT00436969|144552257|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|||||TWO_SIDED|95.0|-15.6|15.1||||||Asymptotic 95% confidence interval for the treatment group difference (Orthovisc - Control) in proportions of responders was calculated. The null hypothesis (Ho) is that the effect of the two treatment groups at 6 months is equal and the corresponding alternative hypothesis (Ha) is that the effect of the two treatment groups at 6 months is unequal.||15.1|-15.6|
72510916|NCT00436969|144552258|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.3|||||TWO_SIDED|95.0|-19.7|9.1||||||Asymptotic 95% confidence interval for the treatment group difference (Orthovisc - Control) in proportions of responders was calculated. The null hypothesis (Ho) is that the effect of the two treatment groups at 6 months is equal and the corresponding alternative hypothesis (Ha) is that the effect of the two treatment groups at 6 months is unequal.||9.1|-19.7|
72510917|NCT00436969|144552259|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.87||||0.827|TWO_SIDED|95.0|-8.698|6.957||The p-value was not adjusted for multiple comparisons. The a priori threshold for significance was a two-sided p \<0.05.|Mixed Models Repeated Measures ANCOVA|The analysis included baseline score as a covariate. Site was dropped from the model due to statistical insignificance.||The null hypothesis (Ho) is that the effect of the two treatment groups at 12 weeks is equal and the corresponding alternative hypothesis (Ha) is that the effect of the two treatment groups is unequal.||6.957|-8.698|0.827
72402044|NCT02515942|144311355|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|0.53||||0.4059|TWO_SIDED|80.0|-2.32|3.37|||Mixed Models Analysis|||Change from baseline at Day 57||3.37|-2.32|0.4059
72402045|NCT02515942|144311355|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|1.24||||0.286|TWO_SIDED|80.0|-1.58|4.05|||Mixed Models Analysis|||Change from baseline at Day 57||4.05|-1.58|0.2860
72402046|NCT02515942|144311355|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|0.71||||0.3727|TWO_SIDED|80.0|-2.1|3.52|||Mixed Models Analysis|||Change from baseline at Day 57||3.52|-2.10|0.3727
72402047|NCT02515942|144311355|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|0.91||||0.336|TWO_SIDED|80.0|-1.85|3.66|||Mixed Models Analysis|||Change from baseline at Day 85||3.66|-1.85|0.3360
72402048|NCT02515942|144311355|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|3.95||||0.0316|TWO_SIDED|80.0|1.24|6.66|||Mixed Models Analysis|||Change from baseline at Day 85||6.66|1.24|0.0316
72402049|NCT02515942|144311355|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|3.04||||0.0762|TWO_SIDED|80.0|0.32|5.76|||Mixed Models Analysis|||Change from baseline at Day 85||5.76|0.32|0.0762
72510918|NCT00436969|144552260|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-2.875||||0.392|TWO_SIDED|95.0|-9.472|3.723||The p-value was not adjusted for multiple comparisons. The a priori threshold for significance was a two-sided p \<0.05.|Mixed Models Repeated Measures ANCOVA|The analysis included baseline score as a covariate. Site was dropped from the model due to statistical insignificance.||The null hypothesis (Ho) is that the effect of the two treatment groups at 12 weeks is equal and the corresponding alternative hypothesis (Ha) is that the effect of the two treatment groups is unequal.||3.723|-9.472|0.392
72510919|NCT00436969|144552261|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.932||||0.772|TWO_SIDED|95.0|-7.26|5.396||The p-value was not adjusted for multiple comparisons. The a priori threshold for significance was a two-sided p \<0.05.|Mixed Models Repeated Measures ANCOVA|The analysis included baseline score as a covariate. Site was dropped from the model due to statistical insignificance.||The null hypothesis (Ho) is that the effect of the two treatment groups at 12 weeks is equal and the corresponding alternative hypothesis (Ha) is that the effect of the two treatment groups is unequal.||5.396|-7.260|0.772
72510920|NCT00436969|144552262|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|1.028||||0.707|TWO_SIDED|95.0|-4.338|6.393||The p-value was not adjusted for multiple comparisons. The a priori threshold for significance was a two-sided p \<0.05.|Mixed Models Repeated Measures ANCOVA|The analysis included baseline score as a covariate. Site was dropped from the model due to statistical insignificance.||The null hypothesis (Ho) is that the effect of the two treatment groups at 12 weeks is equal and the corresponding alternative hypothesis (Ha) is that the effect of the two treatment groups is unequal.||6.393|-4.338|0.707
72510921|NCT00436969|144552263|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.82||||0.79|TWO_SIDED|95.0|-6.866|5.227||The p-value was not adjusted for multiple comparisons. The a priori threshold for significance was a two-sided p \<0.05.|Mixed Models Repeated Measures ANCOVA|The analysis included baseline score as a covariate. Site was dropped from the model due to statistical insignificance.||The null hypothesis (Ho) is that the effect of the two treatment groups at 6 months is equal and the corresponding alternative hypothesis (Ha) is that the effect of the two treatment groups is unequal.||5.227|-6.866|0.790
72566929|NCT02654587|144664497|SUPERIORITY||Hazard Ratio (HR)|1.64|||<|0.05|TWO_SIDED|95.0|1.18|2.28|||t-test, 2 sided|||Median PFS in ITT patients with ICI resistance (primary and secondary)||2.28|1.18|<0.05
72566930|NCT02654587|144664498|SUPERIORITY|ORR in ICI secondary resistance|Odds Ratio (OR)|0.33||||0.07|TWO_SIDED|95.0|0.1|1.11|||Mantel Haenszel|||||1.11|0.10|0.07
72566931|NCT02654587|144664498|SUPERIORITY|ORR in ITT population with ICI resistance (primary and secondary)|Odds Ratio (OR)|0.22||||0.002|TWO_SIDED|95.0|0.08|0.59|||Mantel Haenszel|||||0.59|0.08|0.002
72566932|NCT02654587|144664499|SUPERIORITY|Duration of response at 6 months in ICI secondary resistance|Hazard Ratio (HR)|1.14||||0.88|TWO_SIDED|95.0|0.25|5.3|||Regression, Cox|||||5.30|0.25|0.88
72566933|NCT02654587|144664499|SUPERIORITY|Duration of Response at 6 months in ITT population with ICI resistance (primary and secondary)|Hazard Ratio (HR)|1.41||||0.57|TWO_SIDED|95.0|0.43|4.6|||Regression, Cox|||||4.60|0.43|0.57
72402050|NCT02515942|144311355|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|3.68||||0.0544|TWO_SIDED|80.0|0.75|6.61|||Mixed Models Analysis|||Change from baseline at Day 113||6.61|0.75|0.0544
72566934|NCT02654587|144664500|SUPERIORITY|Time to next lung cancer therapy in ICI secondary resistance|Hazard Ratio (HR)|1.85||||0.04|TWO_SIDED|95.0|1.03|3.31|||Regression, Cox|||||3.31|1.03|0.04
72402051|NCT02515942|144311355|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|1.91||||0.1955|TWO_SIDED|80.0|-0.95|4.77|||Mixed Models Analysis|||Change from baseline at Day 113||4.77|-0.95|0.1955
72482267|NCT01176968|144491870|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||Signed Rank Test|||For Biomarker- PIIINP, signed rank test for change from baseline at Month 6 within treatment difference was used to derive p-value.||||< 0.0001
72510922|NCT00436969|144552264|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|1.13||||0.685|TWO_SIDED|95.0|-4.341|6.001||The p-value was not adjusted for multiple comparisons. The a priori threshold for significance was a two-sided p \<0.05.|Mixed Models Repeated Measures ANCOVA|The analysis included baseline score as a covariate. Site was dropped from the model due to statistical insignificance.||The null hypothesis (Ho) is that the effect of the two treatment groups at 6 months is equal and the corresponding alternative hypothesis (Ha) is that the effect of the two treatment groups is unequal.||6.001|-4.341|0.685
72482268|NCT01176968|144491870|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1558|TWO_SIDED||||||Wilcoxon-Rank Sum test|||For Biomarker- PIIINP, Wilconxon rank-sum test for between treatment difference at Month 6 was used to derive p-value.||||0.1558
72482269|NCT01176968|144491870|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0008|TWO_SIDED||||||Signed Rank Test|||For Biomarker- Galecting 3, signed rank test for change from baseline at Month 6 within treatment difference was used to derive p-value.||||0.0008
72482270|NCT01176968|144491870|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||Signed Rank Test|||For Biomarker- Galecting 3, signed rank test for change from baseline at Month 6 within treatment difference was used to derive p-value.||||< 0.0001
72482271|NCT01176968|144491870|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0293|TWO_SIDED||||||Wilcoxon Rank-Sum test|||For Biomarker- Galecting 3, Wilconxon rank-sum test for between treatment difference at Month 6 was used to derive p-value.||||0.0293
72482272|NCT01176968|144491870|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1723|TWO_SIDED||||||Signed Rank Test|||For Biomarker- PINP, signed rank test for change from baseline at Month 6 within treatment difference was used to derive p-value.||||0.1723
72482273|NCT01176968|144491870|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0295|TWO_SIDED||||||Signed Rank Test|||For Biomarker- PINP, signed rank test for change from baseline at Month 6 within treatment difference was used to derive p-value.||||0.0295
72482274|NCT01176968|144491870|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0865|TWO_SIDED||||||Wilcoxon Rank-Sum test|||For Biomarker- PINP, Wilconxon rank-sum test for between treatment difference at Month 6 was used to derive p-value.||||0.0865
72482275|NCT01176968|144491871|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0944|TWO_SIDED||||||Signed Rank Test|||For Biomarker- ICTP, signed rank test for change from baseline at Month 6 within treatment difference was used to derive p-value.||||0.0944
72482276|NCT01176968|144491871|SUPERIORITY_OR_OTHER_LEGACY|||||||0.036|TWO_SIDED||||||Signed Rank Test|||For Biomarker- ICTP, signed rank test for change from baseline at Month 6 within treatment difference was used to derive p-value.||||0.0360
72482277|NCT01176968|144491871|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6459|TWO_SIDED||||||Wilcoxon Rank-Sum test|||For Biomarker- ICTP, Wilconxon rank-sum test for between treatment difference at Month 6 was used to derive p-value.||||0.6459
72566935|NCT02654587|144664500|SUPERIORITY|Time to next lung cancer therapy in ITT population with ICI resistance (primary and secondary)|Hazard Ratio (HR)|1.59||||0.02|TWO_SIDED|95.0|1.07|2.36|||Regression, Cox|||||2.36|1.07|0.02
72566936|NCT02654587|144664501|SUPERIORITY||Hazard Ratio (HR)|1.36|||<|0.05|TWO_SIDED|95.0|1.0|1.86|||t-test, 2 sided|||||1.86|1.00|<0.05
72566937|NCT01338987|144664509|OTHER|||||||0.0075|||||||Wilcoxon's rank sum test|||||||0.0075
72566938|NCT03856593|144664514|SUPERIORITY||Slope|-0.14|STANDARD_ERROR_OF_MEAN|0.03|<|0.05|TWO_SIDED|95.0|-0.2|-0.07|||Mixed Models Analysis||This is the interaction coefficient for the difference-in-difference in average weekly MME pre-to-post letter between study arms. It was used to acquire the estimated average weekly MME post-letter in the Outcome Measure Data table.|Please note that 10% of means in the pre-intervention period were trimmed to remove outliers.||-0.07|-0.20|<0.05
72566939|NCT03856593|144664515|SUPERIORITY||Slope|-0.09|STANDARD_ERROR_OF_MEAN|0.03|<|0.05|TWO_SIDED|95.0|-0.15|-0.02|||Mixed Models Analysis||This is the interaction coefficient for the difference-in-difference in average weekly MME pre-to-post letter between study arms. It was used to acquire the estimated average weekly VME post-letter in the Outcome Measure Data table.|||-0.02|-0.15|<0.05
72482278|NCT01176968|144491872|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||Signed Rank Test|||For Biomarker- Interleukin-6, signed rank test for change from baseline at Month 6 within treatment difference was used to derive p-value.||||< 0.0001
72482279|NCT01176968|144491872|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||Signed Rank Test|||For Biomarker- Interleukin-6, signed rank test for change from baseline at Month 6 within treatment difference was used to derive p-value.||||< 0.0001
72482280|NCT01176968|144491872|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0801|TWO_SIDED||||||Wilcoxon Rank-Sum test|||For Biomarker- Interleukin-6, Wilconxon rank-sum test for between treatment difference at Month 6 was used to derive p-value.||||0.0801
72482281|NCT05193500|144491893|OTHER|||||||0.085||||||a priori threshold for statistical significance is 0.05|t-test, 2 sided|one-sample t-test, compared to 0.5 (chance)||||||0.085
72482282|NCT05193500|144491893|OTHER|||||||0.049||||||a priori threshold for statistical significance is 0.05|t-test, 2 sided|||||||0.049
72482283|NCT05193500|144491894|OTHER|||||||0.015||||||a priori threshold for statistical significance = 0.05|t-test, 2 sided|||||||0.015
72482284|NCT01106014|144491910|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.6|||<|0.0001|TWO_SIDED|99.0|0.46|0.78||one-sided p-value|Log Rank|||The primary analysis was performed on the Full Analysis Set by a one-sided unstratified log-rank test||0.78|0.46|<0.0001
72482285|NCT01106014|144491911|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|12.0||||0.0027|TWO_SIDED|99.0|1.0|24.0||One-sided p-value of the nonparametric ANCOVA, adjusted for 6-minute walk distance at baseline|ANCOVA||Point estimate and 2-sided 99% CI for location shift using the HodgesLehmann method|Non-parametric ANCOVA with 6MWD as covariate at baseline. Missing values were imputed based on the following imputation rules: 1) if patient was unable to walk at week 26, 0 meter was imputed, 2) if rule 1 did not apply, the second lowest observed 6MWD value (10 meters) at Week 26 was imputed. Missing values were imputed for 21.6% of the subjects.||24|1|0.0027
72482286|NCT01106014|144491912|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|It was assumed that the probabilities for absence of worsening in WHO FC at Week 26 were the same for both treatment groups|Odds Ratio, log|1.161||||0.2843|TWO_SIDED|99.0|0.811|1.664||Cochran-Mantel-Haenszel test stratified by WHO FC at baseline. For patients with missing NYHA/WHO FC at Week 26, the NYHA/WHO FC is considered as having worsened from baseline at Week 26. Missing values were imputed for 18.3% of subjects .|Cochran-Mantel-Haenszel|||||1.664|0.811|0.2843
72482287|NCT00784693|144491922|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|0.41|STANDARD_ERROR_OF_MEAN|0.75|||TWO_SIDED|90.0|-0.87|1.69||||||Week 8: Analysis was based on analysis of co-variance (ANCOVA) model with main effects of treatment, contraceptive use and baseline severity of pain.||1.69|-0.87|
72482288|NCT02260882|144491953|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 1 sided|||Serotype 3. The statistical success criterion for demonstrating greater geometric mean antibody concentrations at 4 weeks postvaccination is that the lower bound of the 2-sided 95% confidence interval in Geometric Mean Fold Rise will be greater than 1 for all 3 serotypes.||||<0.001
72482289|NCT02260882|144491953|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 1 sided|||Serotype 6B. The statistical success criterion for demonstrating greater geometric mean antibody concentrations at 4 weeks postvaccination is that the lower bound of the 2-sided 95% confidence interval in Geometric Mean Fold Rise will be greater than 1 for all 3 serotypes.||||<0.001
72482290|NCT02260882|144491953|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 1 sided|||Serotype 23F. The statistical success criterion for demonstrating greater geometric mean antibody concentrations at 4 weeks postvaccination is that the lower bound of the 2-sided 95% confidence interval in Geometric Mean Fold Rise will be greater than 1 for all 3 serotypes.||||<0.001
72482291|NCT02119325|144491963|SUPERIORITY_OR_OTHER||Difference in Adjusted Mean|-4.64||||0.0487|TWO_SIDED|95.0|-9.26|-0.03||Statistical significance at the 5% level was required for both co-primary endpoints in order to progress to formal assessment of secondary endpoints.|ANOVA||Difference is test minus placebo such that a positive difference means the test has higher Cmax|"H0: There was no difference in the post prandial glucose peak for participants with IFG between the test and placebo.~The primary parameter was analysed using a mixed effects model with glucose as dependent variable, treatment and period as fixed effects and subject as random effect."||-0.03|-9.26|0.0487
72482292|NCT02119325|144491964|SUPERIORITY_OR_OTHER||Difference in Adjusted Mean|-6.79||||0.6116|TWO_SIDED|95.0|-34.02|20.44||Statistical significance at the 5% level was required for both co-primary endpoints in order to progress to formal assessment of secondary endpoints.|ANOVA||Difference is test minus placebo such that a positive difference means the test has higher Cmax|"H0: There was no difference in the post prandial triglyceride peak for participants with IFG between the test and placebo.~The primary parameter was analysed using a mixed effects model with triglyceride as dependent variable, treatment and period as fixed effects and subject as random effect."||20.44|-34.02|0.6116
72482293|NCT01776424|144492060|SUPERIORITY||Hazard Ratio (HR)|0.76||||4e-05|TWO_SIDED|95.0|0.66|0.86||Independent DSMB recommended to stop rivaroxaban/aspirin arms on 06FEB2017. At first interim analysis(\~50% events) the log-rank test statistic for one primary comparison had crossed the modified Haybittle-Peto boundary(z=4) consistently over 3 months|Log Rank|Log-rank test (stratified by pantoprazole randomization)|Stratified Cox proportional hazards model|||0.86|0.66|0.00004
72482294|NCT01776424|144492060|SUPERIORITY||Hazard Ratio (HR)|0.9||||0.1149|TWO_SIDED|95.0|0.79|1.03|||Log Rank|Log-rank test (stratified by pantoprazole randomization)|Stratified Cox proportional hazards model|||1.03|0.79|0.11490
72482295|NCT01776424|144492061|SUPERIORITY||Hazard Ratio (HR)|1.7|||<|1e-05|TWO_SIDED|95.0|1.4|2.05|||Log Rank|Log-rank test (stratified by pantoprazole randomization)|Stratified Cox proportional hazards model|||2.05|1.40|<0.00001
72482296|NCT01776424|144492061|SUPERIORITY||Hazard Ratio (HR)|1.51||||3e-05|TWO_SIDED|95.0|1.25|1.84|||Log Rank|Log-rank test (stratified by pantoprazole randomization)|Stratified Cox proportional hazards model|||1.84|1.25|0.00003
72482297|NCT01776424|144492062|SUPERIORITY||Hazard Ratio (HR)|0.72||||1e-05|TWO_SIDED|95.0|0.63|0.83||Nominal p-value|Log Rank|Log-rank test (stratified by pantoprazole randomization)|Stratified Cox proportional hazards model|||0.83|0.63|0.00001
72510923|NCT00436969|144552265|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|7.317||||0.018|TWO_SIDED|95.0|1.249|13.386||The p-value was not adjusted for multiple comparisons. The a priori threshold for significance was a two-sided p \<0.05.|Mixed Models Repeated Measures ANCOVA|The analysis included baseline score as a covariate. Site was dropped from the model due to statistical insignificance.||The null hypothesis (Ho) is that the effect of the two treatment groups at 12 weeks is equal and the corresponding alternative (Ha) is that the effect of the two treatment groups at 6 months is unequal.||13.386|1.249|0.018
72510924|NCT00436969|144552266|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|2.361||||0.369|TWO_SIDED|95.0|-2.801|7.522||The p-value was not adjusted for multiple comparisons. The a priori threshold for significance was a two-sided p \<0.05.|Mixed Models Repeated Measures ANCOVA|The analysis included baseline score as a covariate. Site was dropped from the model due to statistical insignificance.||The null hypothesis (Ho) is that the effect of the two treatment groups at 12 weeks is equal and the corresponding alternative hypothesis (Ha) is that the effect of the two treatment groups is unequal.||7.522|-2.801|0.369
72510925|NCT00436969|144552267|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-2.79||||0.41|TWO_SIDED|95.0|-9.441|3.861||The a priori threshold for significance was a two-sided p \<0.05.|Mixed Models Repeated Measures ANCOVA|The analysis included baseline score as a covariate. Site was dropped from the model due to statistical insignificance.||Anticipated VAS difference of 10 mm and SD of 25 mm indicated a sample size of 225 subjects in a 2:1 randomization would provide 80% power to detect a significant difference with a two-sided significance level of 5%. To account for a 15% dropout rate the sample size was increased to 270 subjects (180 Orthovisc, 90 control). The primary null hypothesis (Ho) no difference in VAS means at 6 months and the alternative hypothesis (Ha) was that Orthovisc (mean VAS) is superior to the control.||3.861|-9.441|0.410
72510926|NCT00436969|144552268|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|2.617||||0.379|TWO_SIDED|95.0|-3.226|8.46||The p-value was not adjusted for multiple comparisons. The a priori threshold for significance was a two-sided p \<0.05.|Mixed Models Repeated Measures ANCOVA|The analysis included baseline score as a covariate. Site was dropped from the model due to statistical insignificance.||The null hypothesis (Ho) is that the effect of the two treatment groups at 6 months is equal and the corresponding alternative (Ha) is that the effect of the two treatment groups at 6 months is unequal.||8.460|-3.226|0.379
72402052|NCT02515942|144311355|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-1.77||||0.7844|TWO_SIDED|80.0|-4.65|1.12|||Mixed Models Analysis|||Change from baseline at Day 113||1.12|-4.65|0.7844
72402053|NCT02515942|144311355|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|1.49||||0.2973|TWO_SIDED|80.0|-2.11|5.08|||Mixed Models Analysis|||Change from baseline at Day 141||5.08|-2.11|0.2973
72510927|NCT00436969|144552269|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-2.208||||0.409|TWO_SIDED|95.0|-7.455|3.039||The p-value was not adjusted for multiple comparisons. The a priori threshold for significance was a two-sided p \<0.05.|Mixed Models Repeated Measures ANCOVA|The analysis included baseline score as a covariate. Site was dropped from the model due to statistical insignificance.||The null hypothesis (Ho) is that the effect of the two treatment groups at 6 months is equal and the corresponding alternative hypothesis (Ha) is that the effect of the two treatment groups is unequal.||3.039|-7.455|0.409
72510928|NCT00436969|144552270|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.558||||0.232|TWO_SIDED|95.0|-4.119|1.003||The p-value was not adjusted for multiple comparisons. The a priori threshold for significance was a two-sided p \<0.05.|Mixed Models Repeated Measures ANCOVA|The analysis included baseline score as a covariate. Site was dropped from the model due to statistical insignificance.||The null hypothesis (Ho) is that the effect of the two treatment groups at 12 weeks is equal and the corresponding alternative (Ha) is that the effect of the two treatment groups at 6 months is unequal.||1.003|-4.119|0.232
72510929|NCT00436969|144552271|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.228||||0.832|TWO_SIDED|95.0|-2.343|1.887||The p-value was not adjusted for multiple comparisons. The a priori threshold for significance was a two-sided p \<0.05.|Mixed Models Repeated Measures ANCOVA|The analysis included baseline score as a covariate. Site was dropped from the model due to statistical insignificance.||The null hypothesis (Ho) is that the effect of the two treatment groups at 12 weeks is equal and the corresponding alternative hypothesis (Ha) is that the effect of the two treatment groups is unequal.||1.887|-2.343|0.832
72510930|NCT00436969|144552272|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.068||||0.957|TWO_SIDED|95.0|-2.396|2.532||The p-value was not adjusted for multiple comparisons. The a priori threshold for significance was a two-sided p \<0.05.|Mixed Models Repeated Measures ANCOVA|The analysis included baseline score as a covariate. Site was dropped from the model due to statistical insignificance.||The null hypothesis (Ho) is that the effect of the two treatment groups at 6 months is equal and the corresponding alternative (Ha) is that the effect of the two treatment groups at 6 months is unequal.||2.532|-2.396|0.957
72482298|NCT01776424|144492062|SUPERIORITY||Hazard Ratio (HR)|0.88||||0.06437|TWO_SIDED|95.0|0.77|1.01||Nominal p-value|Log Rank|Log-rank test (stratified by pantoprazole randomization)|Stratified Cox proportional hazards model|||1.01|0.77|0.06437
72510931|NCT00436969|144552273|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|1.22||||0.267|TWO_SIDED|95.0|-0.937|3.378||The p-value was not adjusted for multiple comparisons. The a priori threshold for significance was a two-sided p \<0.05.|Mixed Models Repeated Measures ANCOVA|The analysis included baseline score as a covariate. Site was dropped from the model due to statistical insignificance.||The null hypothesis (Ho) is that the effect of the two treatment groups at 6 months is equal and the corresponding alternative hypothesis (Ha) is that the effect of the two treatment groups is unequal.||3.378|-0.937|0.267
72566940|NCT01949116|144664516|NON_INFERIORITY|The P-value for the risk difference is from an asymptotic non-inferiority analysis for the proportion (risk) difference with a 15% non-inferiority margin.|Risk Difference (RD)|0.072||||0.0367|ONE_SIDED|90.0||0.134|||Farrington-Manning score (exact)||LDMTX - Placebo|||0.134||0.0367
72482299|NCT01776424|144492063|SUPERIORITY||Hazard Ratio (HR)|0.74||||1e-05|TWO_SIDED|95.0|0.65|0.85||Nominal p-value|Log Rank|Log-rank test (stratified by pantoprazole randomization)|Stratified Cox proportional hazards model|||0.85|0.65|0.00001
72482300|NCT01776424|144492063|SUPERIORITY||Hazard Ratio (HR)|0.88||||0.03995||95.0|0.77|0.99||Nominal p-value|Log Rank|Log-rank test (stratified by pantoprazole randomization)|Stratified Cox proportional hazards model|||0.99|0.77|0.03995
72482301|NCT01776424|144492064|SUPERIORITY||Hazard Ratio (HR)|0.82||||0.01062|TWO_SIDED|95.0|0.71|0.96||Nominal p-value|Log Rank|Log-rank test (stratified by pantoprazole randomization)|Stratified Cox proportional hazards model|||0.96|0.71|0.01062
72482302|NCT01776424|144492064|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.66418|TWO_SIDED|95.0|0.84|1.12||Nominal p-value|Log Rank|Log-rank test (stratified by pantoprazole randomization)|Stratified Cox proportional hazards model|||1.12|0.84|0.66418
72482303|NCT00186069|144492086|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.2||||0.68|TWO_SIDED|95.0|0.77|1.86|||Fisher Exact|||||1.86|0.77|0.68
72482304|NCT00186069|144492087|SUPERIORITY_OR_OTHER|||||||0.52|||||||Wilcoxon (Mann-Whitney)|||||||0.52
72482305|NCT00186069|144492088|SUPERIORITY_OR_OTHER|||||||0.95|||||||Fisher Exact|||||||0.95
72482306|NCT01498289|144492105|SUPERIORITY||Cox Proportional Hazard|0.91||||0.83|TWO_SIDED|95.0|0.41|2.05|||Regression, Cox|||||2.05|0.41|0.83
72482307|NCT01498289|144492106|SUPERIORITY||Hazard Ratio (HR)|0.68||||0.02|TWO_SIDED|95.0|0.5|0.93|||Regression, Cox|||||0.93|0.50|0.02
72482308|NCT01498289|144492107|SUPERIORITY||Hazard Ratio (HR)|0.82||||0.2|TWO_SIDED|95.0|0.61|1.11|||Regression, Cox|||||1.11|0.61|0.20
72482309|NCT01498289|144492108|SUPERIORITY|||||||0.1|||||||Chi-squared|||||||0.10
72482310|NCT01498289|144492109|SUPERIORITY||Hazard Ratio (HR)|0.78||||0.41|TWO_SIDED|95.0|0.44|1.4|||Regression, Cox|||Statistical analysis for Q1 ERCC1||1.40|0.44|0.41
72482311|NCT01498289|144492109|SUPERIORITY||Hazard Ratio (HR)|0.57||||0.06|TWO_SIDED|95.0|0.32|1.02|||Regression, Cox|||Statistical analysis for Q2 ERCC1||1.02|0.32|0.06
72510932|NCT00436969|144552274|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|1.19||||0.333|TWO_SIDED|95.0|-1.225|3.604||The p-value was not adjusted for multiple comparisons. The a priori threshold for significance was a two-sided p \<0.05.|Mixed Models Repeated Measures ANCOVA|The analysis included baseline score as a covariate. Site was dropped from the model due to statistical insignificance.||The null hypothesis (Ho) is that the effect of the two treatment groups at 12 weeks is equal and the corresponding alternative (Ha) is that the effect of the two treatment groups at 6 months is unequal.||3.604|-1.225|0.333
72510933|NCT00436969|144552275|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.771||||0.473|TWO_SIDED|95.0|-1.339|2.881||The p-value was not adjusted for multiple comparisons. The a priori threshold for significance was a two-sided p \<0.05.|Mixed Models Repeated Measures ANCOVA|The analysis included baseline score as a covariate. Site was dropped from the model due to statistical insignificance.||The null hypothesis (Ho) is that the effect of the two treatment groups at 12 weeks is equal and the corresponding alternative hypothesis (Ha) is that the effect of the two treatment groups is unequal.||2.881|-1.339|0.473
72510934|NCT00436969|144552276|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.018||||0.988|TWO_SIDED|95.0|-2.314|2.278||The p-value was not adjusted for multiple comparisons. The a priori threshold for significance was a two-sided p \<0.05.|Mixed Models Repeated Measures ANCOVA|The analysis included baseline score as a covariate. Site was dropped from the model due to statistical insignificance.||The null hypothesis (Ho) is that the effect of the two treatment groups at 6 months is equal and the corresponding alternative (Ha) is that the effect of the two treatment groups at 6 months is unequal.||2.278|-2.314|0.988
72510935|NCT00436969|144552277|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.467||||0.671|TWO_SIDED|95.0|-1.692|2.627||The p-value was not adjusted for multiple comparisons. The a priori threshold for significance was a two-sided p \<0.05.|Mixed Models Repeated Measures ANCOVA|The analysis included baseline score as a covariate. Site was dropped from the model due to statistical insignificance.||The null hypothesis (Ho) is that the effect of the two treatment groups at 6 months is equal and the corresponding alternative hypothesis (Ha) is that the effect of the two treatment groups is unequal.||2.627|-1.692|0.671
72510936|NCT00905307|144552278|SUPERIORITY_OR_OTHER||Treatment difference|-4.7||||0.2846|TWO_SIDED|95.0|-10.2|0.82||The Hochberg procedure using two-sided alpha of 0.05 was applied to control the type I error rate at 0.05 level (two-sided) due to multiple comparisons.|ANCOVA|With treatment and trial center as main effects, and baseline value as covariate||Sample size was determined to achieve at least 80% power at alpha level of 0.0167 (two-sided) to detect a difference of -11.5 points in the mean change from baseline in PANSS Total Score at week 6 (LOCF) between an individual OPC-34712 treatment group (except the 0.25 mg QD fixed dose group) and placebo using a two-sided z-test.||0.82|-10.2|0.2846
72510937|NCT00905307|144552278|SUPERIORITY_OR_OTHER||Treatment difference|-1.44||||0.6066|TWO_SIDED|95.0|-6.96|4.07||The Hochberg procedure using two-sided alpha of 0.05 was applied to control the type I error rate at 0.05 level (two-sided) due to multiple comparisons.|ANCOVA|With treatment and trial center as main effects, and baseline value as covariate||Sample size was determined to achieve at least 80% power at alpha level of 0.0167 (two-sided) to detect a difference of -11.5 points in the mean change from baseline in PANSS Total Score at week 6 (LOCF) between an individual OPC-34712 treatment group (except the 0.25 mg QD fixed dose group) and placebo using a two-sided z-test||4.07|-6.96|0.6066
72510938|NCT00905307|144552278|SUPERIORITY_OR_OTHER||Treatment difference|-3.86||||0.3293|TWO_SIDED|95.0|-9.32|1.59||The Hochberg procedure using two-sided alpha of 0.05 was applied to control the type I error rate at 0.05 level (two-sided) due to multiple comparisons.|ANCOVA|With treatment and trial center as main effects, and baseline value as covariate||Sample size was determined to achieve at least 80% power at alpha level of 0.0167 (two-sided) to detect a difference of -11.5 points in the mean change from baseline in PANSS Total Score at week 6 (LOCF) between an individual OPC-34712 treatment group (except the 0.25 mg QD fixed dose group) and placebo using a two-sided z-test||1.59|-9.32|0.3293
72510939|NCT00905307|144552278|SUPERIORITY_OR_OTHER||Treatment difference|4.62||||0.2263|TWO_SIDED|95.0|-2.89|12.12|||ANCOVA|With treatment and trial center as main effects, and baseline value as covariate||Sample size was determined to achieve at least 80% power at alpha level of 0.0167 (two-sided) to detect a difference of -11.5 points in the mean change from baseline in PANSS Total Score at week 6 (LOCF) between an individual OPC-34712 treatment group (except the 0.25 mg QD fixed dose group) and placebo using a two-sided z-test||12.12|-2.89|0.2263
72510940|NCT00905307|144552278|SUPERIORITY_OR_OTHER||Treatment difference|-3.64||||0.3074|TWO_SIDED|95.0|-10.7|3.38|||ANCOVA|With treatment and trial center as main effects, and baseline value as covariate||||3.38|-10.7|0.3074
72510941|NCT00905307|144552279|SUPERIORITY_OR_OTHER||Treatment difference|1.61||||0.1807|TWO_SIDED|95.0|-0.75|3.97|||ANCOVA|With treatment and trial center as main effects, and baseline value as covariate||Sample size was determined to achieve at least 80% power at alpha level of 0.0167 (two-sided) to detect a difference of -11.5 points in the mean change from baseline in PANSS positive subscale score at week 6 (LOCF) between an individual OPC-34712 treatment group (except the 0.25 mg QD fixed dose group) and placebo using a two-sided z-test.||3.97|-0.75|0.1807
72510942|NCT00905307|144552279|SUPERIORITY_OR_OTHER||Treatment difference|-1.41||||0.1313|TWO_SIDED|95.0|-3.24|0.42|||ANCOVA|With treatment and trial center as main effects, and baseline value as covariate||Sample size was determined to achieve at least 80% power at alpha level of 0.0167 (two-sided) to detect a difference of -11.5 points in the mean change from baseline in PANSS positive subscale score at week 6 (LOCF) between an individual OPC-34712 treatment group (except the 0.25 mg QD fixed dose group) and placebo using a two-sided z-test.||0.42|-3.24|0.1313
72402054|NCT02515942|144311355|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|1.33||||0.3127|TWO_SIDED|80.0|-2.18|4.84|||Mixed Models Analysis|||Change from baseline at Day 141||4.84|-2.18|0.3127
72510943|NCT00905307|144552279|SUPERIORITY_OR_OTHER||Treatment difference|-0.13||||0.8879|TWO_SIDED|95.0|-1.96|1.69|||ANCOVA|||Sample size was determined to achieve at least 80% power at alpha level of 0.0167 (two-sided) to detect a difference of -11.5 points in the mean change from baseline in PANSS positive subscale score at week 6 (LOCF) between an individual OPC-34712 treatment group (except the 0.25 mg QD fixed dose group) and placebo using a two-sided z-test||1.69|-1.96|0.8879
72402055|NCT02515942|144311355|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-0.16||||0.5227|TWO_SIDED|80.0|-3.67|3.36|||Mixed Models Analysis|||Change from baseline at Day 141||3.36|-3.67|0.5227
72402056|NCT02515942|144311355|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-1.63||||0.7643|TWO_SIDED|80.0|-4.54|1.28|||Mixed Models Analysis|||Change from baseline at Day 169||1.28|-4.54|0.7643
72402057|NCT02515942|144311355|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-1.38||||0.7331|TWO_SIDED|80.0|-4.25|1.48|||Mixed Models Analysis|||Change from baseline at Day 169||1.48|-4.25|0.7331
72402058|NCT02515942|144311355|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|0.25||||0.4557|TWO_SIDED|80.0|-2.59|3.09|||Mixed Models Analysis|||Change from baseline at Day 169||3.09|-2.59|0.4557
72402059|NCT02515942|144311355|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|0.29||||0.4549|TWO_SIDED|80.0|-2.97|3.55|||Mixed Models Analysis|||Change from baseline at Day 197||3.55|-2.97|0.4549
72402060|NCT02515942|144311355|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|0.93||||0.3535|TWO_SIDED|80.0|-2.26|4.13|||Mixed Models Analysis|||Change from baseline at Day 197||4.13|-2.26|0.3535
72510944|NCT00905307|144552279|SUPERIORITY_OR_OTHER||Treatment difference|-1.24||||0.1764|TWO_SIDED|95.0|-3.05|0.56|||ANCOVA|With treatment and trial center as main effects, and baseline value as covariate||Sample size was determined to achieve at least 80% power at alpha level of 0.0167 (two-sided) to detect a difference of -11.5 points in the mean change from baseline in PANSS positive subscale score at week 6 (LOCF) between an individual OPC-34712 treatment group (except the 0.25 mg QD fixed dose group) and placebo using a two-sided z-test.||0.56|-3.05|0.1764
72510945|NCT00905307|144552279|SUPERIORITY_OR_OTHER||Treatment difference|-1.79||||0.1111|TWO_SIDED|95.0|-4.0|0.42|||ANCOVA|With treatment and trial center as main effects, and baseline value as covariate||Sample size was determined to achieve at least 80% power at alpha level of 0.0167 (two-sided) to detect a difference of -11.5 points in the mean change from baseline in PANSS positive subscale score at week 6 (LOCF) between an individual OPC-34712 treatment group (except the 0.25 mg QD fixed dose group) and placebo using a two-sided z-test.||0.42|-4.00|0.1111
72402061|NCT02515942|144311355|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|0.65||||0.397|TWO_SIDED|80.0|-2.54|3.84|||Mixed Models Analysis|||Change from baseline at Day 197||3.84|-2.54|0.3970
72482312|NCT01498289|144492109|SUPERIORITY||Hazard Ratio (HR)|0.88||||0.66|TWO_SIDED|95.0|0.49|1.58|||Regression, Cox|||Statistical analysis for Q3 ERCC1||1.58|0.49|0.66
72482313|NCT01498289|144492109|SUPERIORITY||Hazard Ratio (HR)|0.74||||0.3|TWO_SIDED|95.0|0.42|1.31|||Regression, Cox|||Statistical analysis for Q4 ERCC1||1.31|0.42|0.30
72510946|NCT00905307|144552280|SUPERIORITY_OR_OTHER||Treatment difference|1.0||||0.2896|TWO_SIDED|95.0|-0.86|2.86|||ANCOVA|With treatment and trial center as main effects, and baseline value as covariate||Sample size was determined to achieve at least 80% power at alpha level of 0.0167 (two-sided) to detect a difference of -11.5 points in the mean change from baseline in PANSS negative subscale score at week 6 (LOCF) between an individual OPC-34712 treatment group (except the 0.25 mg QD fixed dose group) and placebo using a two-sided z-test.||2.86|-0.86|0.2896
72566941|NCT01949116|144664517|SUPERIORITY||Mean Difference (Final Values)|0.09||||0.55|TWO_SIDED|95.0|-0.67|0.85|||Wilcoxon (Mann-Whitney)|Stratified by Statin Use (study stratification factor)||||0.85|-0.67|0.55
72482314|NCT01794923|144492111|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2|TWO_SIDED||||||ANOVA|||Analysis was performed using an analysis of variance (ANOVA) model with treatment, baseline categorical pain severity rating (PSR), sex, and baseline muscle soreness with movement (MSM) terms.||||0.200
72482315|NCT01794923|144492111|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) Mean Difference|7.6||||0.23|TWO_SIDED|95.0|-4.81|19.92|||ANOVA|||Analysis was performed using an ANOVA model with treatment, baseline categorical pain severity rating (PSR), sex, and baseline muscle soreness with movement (MSM) terms.||19.92|-4.81|0.230
72482316|NCT01794923|144492111|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-4.4||||0.484|TWO_SIDED|95.0|-16.81|7.99|||ANOVA|||Analysis was performed using an ANOVA model with treatment, baseline categorical pain severity rating (PSR), sex, and baseline muscle soreness with movement (MSM) terms.||7.99|-16.81|0.484
72482317|NCT01794923|144492111|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|12.0||||0.077|TWO_SIDED|95.0|-1.32|25.25|||ANOVA|||Analysis was performed using an ANOVA model with treatment, baseline categorical pain severity rating (PSR), sex, and baseline muscle soreness with movement (MSM) terms.||25.25|-1.32|0.077
72482318|NCT01794923|144492112|SUPERIORITY_OR_OTHER_LEGACY|||||||0.86|TWO_SIDED||||||ANOVA|||24-48 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||||0.860
72402062|NCT02515942|144311355|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|1.78||||0.2714|TWO_SIDED|80.0|-1.99|5.55|||Mixed Models Analysis|||Change from baseline at Day 225||5.55|-1.99|0.2714
72402063|NCT02515942|144311355|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|1.72||||0.2741|TWO_SIDED|80.0|-1.97|5.41|||Mixed Models Analysis|||Change from baseline at Day 225||5.41|-1.97|0.2741
72510947|NCT00905307|144552280|SUPERIORITY_OR_OTHER||Treatment difference|-0.61||||0.3701|TWO_SIDED|95.0|-1.94|0.72|||ANCOVA|With treatment and trial center as main effects, and baseline value as covariate||Sample size was determined to achieve at least 80% power at alpha level of 0.0167 (two-sided) to detect a difference of -11.5 points in the mean change from baseline in PANSS negative subscale score at week 6 (LOCF) between an individual OPC-34712 treatment group (except the 0.25 mg QD fixed dose group) and placebo using a two-sided z-test.||0.72|-1.94|0.3701
72510948|NCT00905307|144552280|SUPERIORITY_OR_OTHER||Treatment difference|-0.35||||0.6074|TWO_SIDED|95.0|-1.69|0.99|||ANCOVA|With treatment and trial center as main effects, and baseline value as covariate||Sample size was determined to achieve at least 80% power at alpha level of 0.0167 (two-sided) to detect a difference of -11.5 points in the mean change from baseline in PANSS negative subscale score at week 6 (LOCF) between an individual OPC-34712 treatment group (except the 0.25 mg QD fixed dose group) and placebo using a two-sided z-test.||0.99|-1.69|0.6074
72510949|NCT00905307|144552280|SUPERIORITY_OR_OTHER||Treatment difference|-0.73||||0.2777|TWO_SIDED|95.0|-2.05|0.59|||ANCOVA|With treatment and trial center as main effects, and baseline value as covariate||Sample size was determined to achieve at least 80% power at alpha level of 0.0167 (two-sided) to detect a difference of -11.5 points in the mean change from baseline in PANSS negative subscale score at week 6 (LOCF) between an individual OPC-34712 treatment group (except the 0.25 mg QD fixed dose group) and placebo using a two-sided z-test||0.59|-2.05|0.2777
72510950|NCT00905307|144552280|SUPERIORITY_OR_OTHER||Treatment difference|-0.15||||0.8611|TWO_SIDED|95.0|-1.9|1.59|||ANCOVA|With treatment and trial center as main effects, and baseline value as covariate||Sample size was determined to achieve at least 80% power at alpha level of 0.0167 (two-sided) to detect a difference of -11.5 points in the mean change from baseline in PANSS negative subscale score at week 6 (LOCF) between an individual OPC-34712 treatment group (except the 0.25 mg QD fixed dose group) and placebo using a two-sided z-test.||1.59|-1.90|0.8611
72510951|NCT00905307|144552281|SUPERIORITY_OR_OTHER||Treatment difference|-2.36||||0.3726|TWO_SIDED|95.0|-7.57|2.85|||ANCOVA|With treatment and trial center as main effects, and baseline value as covariate||Sample size was determined to achieve at least 80% power at alpha level of 0.0167 (two-sided) to detect a difference of -11.5 points in the mean change from baseline in PSP score at week 6 (LOCF) between an individual OPC-34712 treatment group (except the 0.25 mg QD fixed dose group) and placebo using a two-sided z-test.||2.85|-7.57|0.3726
72510952|NCT00905307|144552281|SUPERIORITY_OR_OTHER||Treatment difference|3.8||||0.0664|TWO_SIDED|95.0|-0.26|7.85|||ANCOVA|With treatment and trial center as main effects, and baseline value as covariate||Sample size was determined to achieve at least 80% power at alpha level of 0.0167 (two-sided) to detect a difference of -11.5 points in the mean change from baseline in PSP score at week 6 (LOCF) between an individual OPC-34712 treatment group (except the 0.25 mg QD fixed dose group) and placebo using a two-sided z-test.||7.85|-0.26|0.0664
72510953|NCT00905307|144552281|SUPERIORITY_OR_OTHER||Treatment difference|2.2||||0.2944|TWO_SIDED|95.0|-1.92|6.32|||ANCOVA|With treatment and trial center as main effects, and baseline value as covariate||Sample size was determined to achieve at least 80% power at alpha level of 0.0167 (two-sided) to detect a difference of -11.5 points in the mean change from baseline in PANSS Total Score at week 6 (LOCF) between an individual OPC-34712 treatment group (except the 0.25 mg QD fixed dose group) and placebo using a two-sided z-test||6.32|-1.92|0.2944
72510954|NCT00905307|144552281|SUPERIORITY_OR_OTHER||Treatment difference|3.86||||0.0596|TWO_SIDED|95.0|-0.16|7.89|||ANCOVA|With treatment and trial center as main effects, and baseline value as covariate||Sample size was determined to achieve at least 80% power at alpha level of 0.0167 (two-sided) to detect a difference of -11.5 points in the mean change from baseline in PANSS Total Score at week 6 (LOCF) between an individual OPC-34712 treatment group (except the 0.25 mg QD fixed dose group) and placebo using a two-sided z-test||7.89|-0.16|0.0596
72510955|NCT00905307|144552281|SUPERIORITY_OR_OTHER||Treatment difference|3.25||||0.1819|TWO_SIDED|95.0|-1.53|8.03|||ANCOVA|With treatment and trial center as main effects, and baseline value as covariate||Sample size was determined to achieve at least 80% power at alpha level of 0.0167 (two-sided) to detect a difference of -11.5 points in the mean change from baseline in PANSS Total Score at week 6 (LOCF) between an individual OPC-34712 treatment group (except the 0.25 mg QD fixed dose group) and placebo using a two-sided z-test||8.03|-1.53|0.1819
72510956|NCT00905307|144552282|SUPERIORITY_OR_OTHER||Treatment difference|0.38||||0.0685|TWO_SIDED|95.0|-0.03|0.79|||ANCOVA|With treatment and trial center as main effects, and baseline value as covariate||Sample size was determined to achieve at least 80% power at alpha level of 0.0167 (two-sided) to detect a difference of -11.5 points in the mean change from baseline in CGI-S score at week 6 (LOCF) between an individual OPC-34712 treatment group (except the 0.25 mg QD fixed dose group) and placebo using a two-sided z-test||0.79|-0.03|0.0685
72510957|NCT00905307|144552282|SUPERIORITY_OR_OTHER||Treatment difference|-0.28||||0.0989|TWO_SIDED|95.0|-0.6|0.05|||ANCOVA|With treatment and trial center as main effects, and baseline value as covariate||Sample size was determined to achieve at least 80% power at alpha level of 0.0167 (two-sided) to detect a difference of -11.5 points in the mean change from baseline in PANSS Total Score at week 6 (LOCF) between an individual OPC-34712 treatment group (except the 0.25 mg QD fixed dose group) and placebo using a two-sided z-test||0.05|-0.60|0.0989
72566942|NCT00788593|144664545|SUPERIORITY_OR_OTHER||Least Square (LS) Mean Difference|1.023||||0.228|TWO_SIDED|95.0|-0.656|2.701|||ANCOVA|||Treatment difference and 95 percent (%) confidence interval (CI) was based on LS mean from analysis of covariance (ANCOVA) which included participant as random effect, treatment, period and sequence as fixed effects, and placebo baseline CFA value as covariate.||2.701|-0.656|0.228
72566943|NCT00788593|144664546|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
72402064|NCT02515942|144311355|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-0.06||||0.5084|TWO_SIDED|80.0|-3.74|3.62|||Mixed Models Analysis|||Change from baseline at Day 225||3.62|-3.74|0.5084
72402065|NCT02515942|144311355|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|2.82||||0.1537|TWO_SIDED|80.0|-0.73|6.37|||Mixed Models Analysis|||Change from baseline at Day 253||6.37|-0.73|0.1537
72402066|NCT02515942|144311355|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|1.79||||0.2542|TWO_SIDED|80.0|-1.69|5.27|||Mixed Models Analysis|||Change from baseline at Day 253||5.27|-1.69|0.2542
72402067|NCT02515942|144311355|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-1.03||||0.6504|TWO_SIDED|80.0|-4.46|2.4|||Mixed Models Analysis|||Change from baseline at Day 253||2.40|-4.46|0.6504
72482319|NCT01794923|144492112|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|7.0||||0.584|TWO_SIDED|95.0|-18.3|32.38|||ANOVA|||24-48 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||32.38|-18.30|0.584
72482320|NCT01794923|144492112|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|2.6||||0.838|TWO_SIDED|95.0|-22.77|28.06|||ANOVA|||24-48 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||28.06|-22.77|0.838
72510958|NCT00905307|144552282|SUPERIORITY_OR_OTHER||Treatment difference|-0.04||||0.8006|TWO_SIDED|95.0|-0.37|0.28|||ANCOVA|With treatment and trial center as main effects, and baseline value as covariate||Sample size was determined to achieve at least 80% power at alpha level of 0.0167 (two-sided) to detect a difference of -11.5 points in the mean change from baseline in PANSS Total Score at week 6 (LOCF) between an individual OPC-34712 treatment group (except the 0.25 mg QD fixed dose group) and placebo using a two-sided z-test.||0.28|-0.37|0.8006
72482321|NCT01794923|144492112|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|4.4||||0.75|TWO_SIDED|95.0|-22.81|31.61|||ANOVA|||24-48 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||31.61|-22.81|0.750
72510959|NCT00905307|144552282|SUPERIORITY_OR_OTHER||Treatment difference|-0.28||||0.0898|TWO_SIDED|95.0|-0.6|0.04|||ANCOVA|With treatment and trial center as main effects, and baseline value as covariate||Sample size was determined to achieve at least 80% power at alpha level of 0.0167 (two-sided) to detect a difference of -11.5 points in the mean change from baseline in PANSS Total Score at week 6 (LOCF) between an individual OPC-34712 treatment group (except the 0.25 mg QD fixed dose group) and placebo using a two-sided z-test||0.04|-0.60|0.0898
72402068|NCT02515942|144311355|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|1.3||||0.3405|TWO_SIDED|80.0|-2.78|5.38|||Mixed Models Analysis|||Change from baseline at Day 281||5.38|-2.78|0.3405
72482322|NCT01794923|144492112|SUPERIORITY_OR_OTHER_LEGACY|||||||0.533|TWO_SIDED||||||ANOVA|||48-72 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||||0.533
72482323|NCT01794923|144492112|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-13.9||||0.326|TWO_SIDED|95.0|-41.81|13.95|||ANOVA|||48-72 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||13.95|-41.81|0.326
72482324|NCT01794923|144492112|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|1.0||||0.945|TWO_SIDED|95.0|-26.98|28.94|||ANOVA|||48-72 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||28.94|-26.98|0.945
72510960|NCT00905307|144552282|SUPERIORITY_OR_OTHER||Treatment difference|-0.21||||0.2851|TWO_SIDED|95.0|-0.59|0.18|||ANCOVA|With treatment and trial center as main effects, and baseline value as covariate||Sample size was determined to achieve at least 80% power at alpha level of 0.0167 (two-sided) to detect a difference of -11.5 points in the mean change from baseline in PANSS Total Score at week 6 (LOCF) between an individual OPC-34712 treatment group (except the 0.25 mg QD fixed dose group) and placebo using a two-sided z-test||0.18|-0.59|0.2851
72510961|NCT00905307|144552283|SUPERIORITY_OR_OTHER|||||||0.4008|||||||Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel (CMH) row mean scores differ test controlling for study center was applied to mean CGI-I score||Sample size was determined to achieve at least 80% power at alpha level of 0.0167 (two-sided) to detect a difference of -11.5 points in the mean change from baseline in PANSS Total Score at week 6 (LOCF) between an individual OPC-34712 treatment group (except the 0.25 mg QD fixed dose group) and placebo using a two-sided z-test||||0.4008
72482325|NCT01794923|144492112|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-14.9||||0.327|TWO_SIDED|95.0|-44.85|15.03|||ANOVA|||48-72 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||15.03|-44.85|0.327
72482326|NCT01794923|144492112|SUPERIORITY_OR_OTHER_LEGACY|||||||0.988|TWO_SIDED||||||ANOVA|||0-72 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||||0.988
72510962|NCT00905307|144552283|SUPERIORITY_OR_OTHER|||||||0.1117|||||||Cochran-Mantel-Haenszel|The CMH row mean scores differ test controlling for study center was applied to mean CGI-I score||Sample size was determined to achieve at least 80% power at alpha level of 0.0167 (two-sided) to detect a difference of -11.5 points in the mean change from baseline in PANSS Total Score at week 6 (LOCF) between an individual OPC-34712 treatment group (except the 0.25 mg QD fixed dose group) and placebo using a two-sided z-test||||0.1117
72510963|NCT00905307|144552283|SUPERIORITY_OR_OTHER|||||||0.2739|||||||Cochran-Mantel-Haenszel|The CMH row mean scores differ test controlling for study center was applied to mean CGI-I score||Sample size was determined to achieve at least 80% power at alpha level of 0.0167 (two-sided) to detect a difference of -11.5 points in the mean change from baseline in PANSS Total Score at week 6 (LOCF) between an individual OPC-34712 treatment group (except the 0.25 mg QD fixed dose group) and placebo using a two-sided z-test.||||0.2739
72510964|NCT00905307|144552283|SUPERIORITY_OR_OTHER|||||||0.1045|||||||Cochran-Mantel-Haenszel|The CMH row mean scores differ test controlling for study center was applied to mean CGI-I score||Sample size was determined to achieve at least 80% power at alpha level of 0.0167 (two-sided) to detect a difference of -11.5 points in the mean change from baseline in PANSS Total Score at week 6 (LOCF) between an individual OPC-34712 treatment group (except the 0.25 mg QD fixed dose group) and placebo using a two-sided z-test.||||0.1045
72510965|NCT00905307|144552283|SUPERIORITY_OR_OTHER|||||||0.1149|||||||Cochran-Mantel-Haenszel|The CMH row mean scores differ test controlling for study center was applied to mean CGI-I score||Sample size was determined to achieve at least 80% power at alpha level of 0.0167 (two-sided) to detect a difference of -11.5 points in the mean change from baseline in PANSS Total Score at week 6 (LOCF) between an individual OPC-34712 treatment group (except the 0.25 mg QD fixed dose group) and placebo using a two-sided z-test.||||0.1149
72510966|NCT00905307|144552284|SUPERIORITY_OR_OTHER||Relative Risk|0.89||||0.62|TWO_SIDED|95.0|0.57|1.4|||Cochran-Mantel-Haenszel|CMH general association test controlling for study center will be applied to the analysis of response rate||Sample size was determined to achieve at least 80% power at alpha level of 0.0167 (two-sided) to detect a difference of -11.5 points in the mean change from baseline in PANSS Total Score at week 6 (LOCF) between an individual OPC-34712 treatment group (except the 0.25 mg QD fixed dose group) and placebo using a two-sided z-test.||1.40|0.57|0.6200
72510967|NCT00905307|144552284|SUPERIORITY_OR_OTHER||Relative Risk|1.19||||0.1501|TWO_SIDED|95.0|0.95|1.48|||Cochran-Mantel-Haenszel|CMH general association test controlling for study center will be applied to the analysis of response rate||Sample size was determined to achieve at least 80% power at alpha level of 0.0167 (two-sided) to detect a difference of -11.5 points in the mean change from baseline in PANSS Total Score at week 6 (LOCF) between an individual OPC-34712 treatment group (except the 0.25 mg QD fixed dose group) and placebo using a two-sided z-test.||1.48|0.95|0.1501
72510968|NCT00905307|144552284|SUPERIORITY_OR_OTHER||Relative Risk|0.91||||0.5271|TWO_SIDED|95.0|0.66|1.25|||Cochran-Mantel-Haenszel|CMH general association test controlling for study center will be applied to the analysis of response rate||Sample size was determined to achieve at least 80% power at alpha level of 0.0167 (two-sided) to detect a difference of -11.5 points in the mean change from baseline in PANSS Total Score at week 6 (LOCF) between an individual OPC-34712 treatment group (except the 0.25 mg QD fixed dose group) and placebo using a two-sided z-test.||1.25|0.66|0.5271
72510969|NCT00905307|144552284|SUPERIORITY_OR_OTHER||Relative Risk|1.02||||0.867|TWO_SIDED|95.0|0.78|1.34|||Cochran-Mantel-Haenszel|CMH general association test controlling for study center will be applied to the analysis of response rate||Sample size was determined to achieve at least 80% power at alpha level of 0.0167 (two-sided) to detect a difference of -11.5 points in the mean change from baseline in PANSS Total Score at week 6 (LOCF) between an individual OPC-34712 treatment group (except the 0.25 mg QD fixed dose group) and placebo using a two-sided z-test||1.34|0.78|0.8670
72510970|NCT00905307|144552284|SUPERIORITY_OR_OTHER||Relative Risk|1.15||||0.3892|TWO_SIDED|95.0|0.85|1.56|||Cochran-Mantel-Haenszel|CMH general association test controlling for study center will be applied to the analysis of response rate||Sample size was determined to achieve at least 80% power at alpha level of 0.0167 (two-sided) to detect a difference of -11.5 points in the mean change from baseline in PANSS Total Score at week 6 (LOCF) between an individual OPC-34712 treatment group (except the 0.25 mg QD fixed dose group) and placebo using a two-sided z-test.||1.56|0.85|0.3892
72510971|NCT00905307|144552285|SUPERIORITY_OR_OTHER||Relative risk|1.06||||0.854|TWO_SIDED|95.0|0.59|1.88||Derived using CMH test stratified by trial center.|Cochran-Mantel-Haenszel|||Sample size was determined to achieve at least 80% power at alpha level of 0.0167 (two-sided) to detect a difference of -11.5 points in the mean change from baseline in PANSS Total Score at week 6 (LOCF) between an individual OPC-34712 treatment group (except the 0.25 mg QD fixed dose group) and placebo using a two-sided z-test.||1.88|0.59|0.8540
72510972|NCT00905307|144552285|SUPERIORITY_OR_OTHER||Relative Risk|0.82||||0.4492|TWO_SIDED|95.0|0.49|1.38||Derived using CMH test stratified by trial center.|Cochran-Mantel-Haenszel|||Sample size was determined to achieve at least 80% power at alpha level of 0.0167 (two-sided) to detect a difference of -11.5 points in the mean change from baseline in PANSS Total Score at week 6 (LOCF) between an individual OPC-34712 treatment group (except the 0.25 mg QD fixed dose group) and placebo using a two-sided z-test||1.38|0.49|0.4492
72566944|NCT00788593|144664546|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
72566945|NCT00788593|144664547|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||||||<0.001
72566946|NCT00788593|144664547|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||||||<0.001
72402069|NCT02515942|144311355|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|2.41||||0.2194|TWO_SIDED|80.0|-1.59|6.42|||Mixed Models Analysis|||Change from baseline at Day 281||6.42|-1.59|0.2194
72566947|NCT03020719|144664550|SUPERIORITY||Mean Difference (Final Values)|-0.081||||0.2521|TWO_SIDED|95.0|-0.221|0.059|||Mixed Models Analysis|Model adjusted for randomization strata: sex, baseline age (\< 6 years, ≥ 6 years), and baseline weight-for-age z-score category (\< -0.52, ≥ -0.52).|Model incorporates Week 12 weight-for-age z-score, assumes unstructured covariance for within-subject measurements, and includes a subject-level random intercept.|||0.059|-0.221|0.2521
72566948|NCT03020719|144664551|SUPERIORITY||Mean Difference (Final Values)|-0.08||||0.089|TWO_SIDED|95.0|-0.18|0.01|||Mixed Models Analysis|Model adjusted for randomization strata: sex, baseline age (\<6 years, ≥6 years), and baseline weight-for-age z-score category (\< -0.52, ≥-0.52).|Model incorporates Week 12 measurements, assumes unstructured covariance for within-subject measurements, and includes a subject-level random intercept.|||0.01|-0.18|0.0890
72482327|NCT01794923|144492112|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-3.2||||0.887|TWO_SIDED|95.0|-48.31|41.81|||ANOVA|||0-72 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||41.81|-48.31|0.887
72482328|NCT01794923|144492112|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-2.7||||0.907|TWO_SIDED|95.0|-47.88|42.5|||ANOVA|||0-72 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||42.50|-47.88|0.907
72482329|NCT01794923|144492112|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.6||||0.982|TWO_SIDED|95.0|-48.95|47.83|||ANOVA|||0-72 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||47.83|-48.95|0.982
72482330|NCT01794923|144492113|SUPERIORITY_OR_OTHER_LEGACY|||||||0.63|TWO_SIDED||||||ANOVA|||1 Hour: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||||0.630
72482331|NCT01794923|144492113|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.1||||0.342|TWO_SIDED|95.0|-0.39|0.14|||ANOVA|||1 Hour: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||0.14|-0.39|0.342
72482332|NCT01794923|144492113|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.1||||0.6|TWO_SIDED|95.0|-0.34|0.19|||ANOVA|||1 Hour: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||0.19|-0.34|0.600
72482333|NCT01794923|144492113|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.1||||0.691|TWO_SIDED|95.0|-0.34|0.23|||ANOVA|||1 Hour: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||0.23|-0.34|0.691
72482334|NCT01794923|144492113|SUPERIORITY_OR_OTHER_LEGACY|||||||0.091|TWO_SIDED||||||ANOVA|||2 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||||0.091
72482335|NCT01794923|144492113|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.1||||0.351|TWO_SIDED|95.0|-0.44|0.16|||ANOVA|||2 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||0.16|-0.44|0.351
72482336|NCT01794923|144492113|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.3||||0.029|TWO_SIDED|95.0|-0.64|-0.04|||ANOVA|||2 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||-0.04|-0.64|0.029
72482337|NCT01794923|144492113|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.2||||0.238|TWO_SIDED|95.0|-0.13|0.52|||ANOVA|||2 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||0.52|-0.13|0.238
72482338|NCT01794923|144492113|SUPERIORITY_OR_OTHER_LEGACY|||||||0.305|TWO_SIDED||||||ANOVA|||3 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||||0.305
72482339|NCT01794923|144492113|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.2||||0.37|TWO_SIDED|95.0|-0.54|0.2|||ANOVA|||3 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||0.20|-0.54|0.370
72482340|NCT01794923|144492113|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.3||||0.13|TWO_SIDED|95.0|-0.66|0.09|||ANOVA|||3 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||0.09|-0.66|0.130
72482341|NCT01794923|144492113|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.1||||0.561|TWO_SIDED|95.0|-0.28|0.51|||ANOVA|||3 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||0.51|-0.28|0.561
72482342|NCT01794923|144492113|SUPERIORITY_OR_OTHER_LEGACY|||||||0.209|TWO_SIDED||||||ANOVA|||4 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||||0.209
72482343|NCT01794923|144492113|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.2||||0.277|TWO_SIDED|95.0|-0.68|0.19|||ANOVA|||4 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||0.19|-0.68|0.277
72482344|NCT01794923|144492113|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.4||||0.085|TWO_SIDED|95.0|-0.82|0.05|||ANOVA|||4 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||0.05|-0.82|0.085
72482345|NCT01794923|144492113|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.1||||0.546|TWO_SIDED|95.0|-0.32|0.61|||ANOVA|||4 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||0.61|-0.32|0.546
72482346|NCT01794923|144492113|SUPERIORITY_OR_OTHER_LEGACY|||||||0.185|TWO_SIDED||||||ANOVA|||5 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||||0.185
72482347|NCT01794923|144492113|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.2||||0.4|TWO_SIDED|95.0|-0.64|0.26|||ANOVA|||5 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||0.26|-0.64|0.400
72482348|NCT01794923|144492113|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.4||||0.067|TWO_SIDED|95.0|-0.88|0.03|||ANOVA|||5 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||0.03|-0.88|0.067
72510973|NCT00905307|144552285|SUPERIORITY_OR_OTHER||Relative Risk|0.67||||0.1854|TWO_SIDED|95.0|0.36|1.23||Derived using CMH test stratified by trial center.|Cochran-Mantel-Haenszel|||Sample size was determined to achieve at least 80% power at alpha level of 0.0167 (two-sided) to detect a difference of -11.5 points in the mean change from baseline in PANSS Total Score at week 6 (LOCF) between an individual OPC-34712 treatment group (except the 0.25 mg QD fixed dose group) and placebo using a two-sided z-test.||1.23|0.36|0.1854
72510974|NCT00905307|144552285|SUPERIORITY_OR_OTHER||Relative Risk|0.61||||0.0946|TWO_SIDED|95.0|0.33|1.1||Derived using CMH test stratified by trial center.|Cochran-Mantel-Haenszel|||Sample size was determined to achieve at least 80% power at alpha level of 0.0167 (two-sided) to detect a difference of -11.5 points in the mean change from baseline in PANSS Total Score at week 6 (LOCF) between an individual OPC-34712 treatment group (except the 0.25 mg QD fixed dose group) and placebo using a two-sided z-test.||1.10|0.33|0.0946
72510975|NCT00905307|144552285|SUPERIORITY_OR_OTHER||Relative Risk|0.63||||0.2133||95.0|0.3|1.34||Derived using CMH test stratified by trial center.|Cochran-Mantel-Haenszel|||Sample size was determined to achieve at least 80% power at alpha level of 0.0167 (two-sided) to detect a difference of -11.5 points in the mean change from baseline in PANSS Total Score at week 6 (LOCF) between an individual OPC-34712 treatment group (except the 0.25 mg QD fixed dose group) and placebo using a two-sided z-test.||1.34|0.30|0.2133
72510976|NCT03280550|144552339|SUPERIORITY||Difference in Least Squares Means|-1.14|STANDARD_ERROR_OF_MEAN|0.23|<|0.0001|TWO_SIDED|95.0|-1.59|-0.69||Tested at the two-sided 0.05 significance level. There was no adjustment for multiplicity for the co-primary outcome measures.|Mixed-Effect Model of Repeated Measures|Adjustments: geographic region, asthma/aspirin sensitivity, treatment, timepoint, baseline NPS, treatment and baseline NPS by timepoint interactions.|Difference in least squares means: Omalizumab arm minus Placebo arm.|The primary analysis tested the null hypothesis that no treatment group difference existed for change from baseline in NPS at Week 24. As NPS and NCS are co-primary outcome measures, both null hypotheses for NPS and NCS must be rejected, with parameter estimates indicating a benefit of omalizumab over placebo, for the study to be deemed positive.||-0.69|-1.59|<0.0001
72510977|NCT03280550|144552340|SUPERIORITY||Difference in Least Squares Means|-0.55|STANDARD_ERROR_OF_MEAN|0.15||0.0004|TWO_SIDED|95.0|-0.84|-0.25||Tested at the two-sided 0.05 significance level. There was no adjustment for multiplicity for the co-primary outcome measures.|Mixed-Effect Model of Repeated Measures|Adjustments: geographic region, asthma/aspirin sensitivity, treatment, timepoint, baseline NCS, treatment and baseline NCS by timepoint interactions.|Difference in least squares means: Omalizumab arm minus Placebo arm.|The primary analysis tested the null hypothesis that no treatment group difference existed for change from baseline in NCS at Week 24. As NPS and NCS are co-primary outcome measures, both null hypotheses for NPS and NCS must be rejected, with parameter estimates indicating a benefit of omalizumab over placebo, for the study to be deemed positive.||-0.25|-0.84|0.0004
72510978|NCT03280550|144552341|SUPERIORITY||Difference in Least Squares Means|-0.33|STANDARD_ERROR_OF_MEAN|0.14||0.0161|TWO_SIDED|95.0|-0.6|-0.06||Tested at the two-sided 0.05 significance level.|Mixed-Effect Model of Repeated Measures|Adjustments: geographic region, asthma/aspirin sensitivity, treatment, timepoint, baseline SSS, treatment and baseline SSS by timepoint interactions.|Difference in least squares means: Omalizumab arm minus Placebo arm.|The null hypothesis was that no difference exists between the treatment groups for change from baseline in the average daily Sense of Smell Score (SSS) at Week 24.||-0.06|-0.60|0.0161
72510979|NCT03280550|144552342|SUPERIORITY||Difference in Least Squares Means|-0.56|STANDARD_ERROR_OF_MEAN|0.14||0.0001|TWO_SIDED|95.0|-0.84|-0.28||Tested at the two-sided 0.05 significance level.|Mixed-Effect Model of Repeated Measures|Adjustments: geographic region, asthma/aspirin sensitivity, treatment, timepoint, baseline PRS, treatment and baseline PRS by timepoint interactions.|Difference in least squares means: Omalizumab arm minus Placebo arm.|The null hypothesis was that no difference exists between the treatment groups for change from baseline in the average daily Posterior Rhinorrhea Score (PRS) at Week 24.||-0.28|-0.84|0.0001
72510980|NCT03280550|144552343|SUPERIORITY||Difference in Least Squares Means|-1.01|STANDARD_ERROR_OF_MEAN|0.21|<|0.0001|TWO_SIDED|95.0|-1.43|-0.6||Tested at the two-sided 0.05 significance level.|Mixed-Effect Model of Repeated Measures|Adjustments: geographic region, asthma/aspirin sensitivity, treatment, timepoint, baseline NPS, treatment and baseline NPS by timepoint interactions.|Difference in least squares means: Omalizumab arm minus Placebo arm.|The null hypothesis was that no difference exists between the treatment groups for change from baseline in the NPS at Week 16.||-0.60|-1.43|<0.0001
72510981|NCT03280550|144552344|SUPERIORITY||Difference in Least Squares Means|-0.57|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-0.83|-0.31||Tested at the two-sided 0.05 significance level.|Mixed-Effect Model of Repeated Measures|Adjustments: geographic region, asthma/aspirin sensitivity, treatment, timepoint, baseline NCS, treatment and baseline NCS by timepoint interactions.|Difference in least squares means: Omalizumab arm minus Placebo arm.|The null hypothesis was that no difference exists between the treatment groups for change from baseline in the average daily NCS at Week 16.||-0.31|-0.83|<0.0001
72566949|NCT03020719|144664552|SUPERIORITY||Mean Difference (Final Values)|-0.06||||0.573|TWO_SIDED|95.0|-0.28|0.15|||Mixed Models Analysis|Model adjusted from randomization strata: sex, baseline age (\<6 years, ≥6 years), and baseline weight-for-age z-score category (\< -0.52, ≥-0.52).|Model incorporates Week 12 measurements, assumes unstructured covariance for within-subject measurements, and includes a subject-level random intercept.|||0.15|-0.28|0.5730
72510982|NCT03280550|144552345|SUPERIORITY||Difference in Least Squares Means|-16.12|STANDARD_ERROR_OF_MEAN|2.9|<|0.0001|TWO_SIDED|95.0|-21.86|-10.38||Tested at the two-sided 0.05 significance level.|Mixed-Effect Model of Repeated Measures|Adjustments: geographic region, asthma/aspirin sensitivity, treatment, timepoint, baseline, treatment and baseline by timepoint interactions.|Difference in least squares means: Omalizumab arm minus Placebo arm.|The null hypothesis was that no difference exists between the treatment groups for change from baseline in the SNOT-22 score at Week 24.||-10.38|-21.86|<0.0001
72566950|NCT03020719|144664553|SUPERIORITY||Mean Difference (Final Values)|0.11||||0.4259|TWO_SIDED|95.0|-0.17|0.4|||Mixed Models Analysis|Model adjusted for randomization strata: sex, baseline age (\<6 years, ≥6 years), and baseline weight-for-age z-score category (\< -0.52, ≥-0.52).|Model incorporates Week 12 measurements, assumes unstructured covariance for within-subject measurements, and includes a subject-level random intercept.|||0.40|-0.17|0.4259
72402070|NCT02515942|144311355|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|1.11||||0.3596|TWO_SIDED|80.0|-2.87|5.09|||Mixed Models Analysis|||Change from baseline at Day 281||5.09|-2.87|0.3596
72402071|NCT02515942|144311355|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-0.07||||0.5086|TWO_SIDED|80.0|-4.04|3.9|||Mixed Models Analysis|||Change from baseline at Day 309||3.90|-4.04|0.5086
72402072|NCT02515942|144311355|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|2.33||||0.2211|TWO_SIDED|80.0|-1.57|6.23|||Mixed Models Analysis|||Change from baseline at Day 309||6.23|-1.57|0.2211
72402073|NCT02515942|144311355|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|2.4||||0.2126|TWO_SIDED|80.0|-1.47|6.26|||Mixed Models Analysis|||Change from baseline at Day 309||6.26|-1.47|0.2126
72402074|NCT02515942|144311355|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|2.56||||0.2053|TWO_SIDED|80.0|-1.44|6.55|||Mixed Models Analysis|||Change from baseline at Day 337||6.55|-1.44|0.2053
72402075|NCT02515942|144311355|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|2.2||||0.2353|TWO_SIDED|80.0|-1.72|6.12|||Mixed Models Analysis|||Change from baseline at Day 337||6.12|-1.72|0.2353
72402076|NCT02515942|144311355|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-0.36||||0.5471|TWO_SIDED|80.0|-4.24|3.53|||Mixed Models Analysis|||Change from baseline at Day 337||3.53|-4.24|0.5471
72402077|NCT02515942|144311356|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-2.74||||0.0913|TWO_SIDED|80.0|-5.38|-0.11|||Mixed Models Analysis|||Change from baseline at Day 2||-0.11|-5.38|0.0913
72566951|NCT03020719|144664554|SUPERIORITY||Mean Difference (Final Values)|-0.55||||0.4666|TWO_SIDED|95.0|-2.06|0.96|||ANCOVA|Model adjusted for randomization strata: sex, baseline age (\<6 years, ≥6 years), and baseline weight-for-age z-score category (\< -0.52, ≥-0.52).||||0.96|-2.06|0.4666
72566952|NCT03020719|144664555|SUPERIORITY||Difference in % of Participants with AE|0.0||||1|TWO_SIDED|95.0|-13.6|13.6|||Fisher Exact||95% CI calculated using the Newcombe-Wilson method without continuity correction.|||13.6|-13.6|1.0000
72482349|NCT01794923|144492113|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.2||||0.35|TWO_SIDED|95.0|-0.25|0.71|||ANOVA|||5 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||0.71|-0.25|0.350
72482350|NCT01794923|144492113|SUPERIORITY_OR_OTHER_LEGACY|||||||0.493|TWO_SIDED||||||ANOVA|||6 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||||0.493
72482351|NCT01794923|144492113|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.0||||0.922|TWO_SIDED|95.0|-0.53|0.48|||ANOVA|||6 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||0.48|-0.53|0.922
72482352|NCT01794923|144492113|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.3||||0.265|TWO_SIDED|95.0|-0.8|0.22|||ANOVA|||6 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||0.22|-0.80|0.265
72482353|NCT01794923|144492113|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.3||||0.342|TWO_SIDED|95.0|-0.28|0.81|||ANOVA|||6 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||0.81|-0.28|0.342
72482354|NCT01794923|144492113|SUPERIORITY_OR_OTHER_LEGACY|||||||0.311|TWO_SIDED||||||ANOVA|||7 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||||0.311
72482355|NCT01794923|144492113|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.0||||0.865|TWO_SIDED|95.0|-0.49|0.58|||ANOVA|||7 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||0.58|-0.49|0.865
72482356|NCT01794923|144492113|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.4||||0.193|TWO_SIDED|95.0|-0.89|0.18|||ANOVA|||7 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||0.18|-0.89|0.193
72482357|NCT01794923|144492113|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.4||||0.17|TWO_SIDED|95.0|-0.17|0.97|||ANOVA|||7 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||0.97|-0.17|0.170
72482358|NCT01794923|144492113|SUPERIORITY_OR_OTHER_LEGACY|||||||0.383|TWO_SIDED||||||ANOVA|||8 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||||0.383
72482359|NCT01794923|144492113|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.1||||0.802|TWO_SIDED|95.0|-0.48|0.62|||ANOVA|||8 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||0.62|-0.48|0.802
72482360|NCT01794923|144492113|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.3||||0.26|TWO_SIDED|95.0|-0.87|0.24|||ANOVA|||8 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||0.24|-0.87|0.260
72482361|NCT01794923|144492113|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.4||||0.199|TWO_SIDED|95.0|-0.21|0.98|||ANOVA|||8 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||0.98|-0.21|0.199
72482362|NCT01794923|144492113|SUPERIORITY_OR_OTHER_LEGACY|||||||0.139|TWO_SIDED||||||ANOVA|||9 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||||0.139
72482363|NCT01794923|144492113|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.2||||0.441|TWO_SIDED|95.0|-0.35|0.8|||ANOVA|||9 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||0.80|-0.35|0.441
72482364|NCT01794923|144492113|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.4||||0.183|TWO_SIDED|95.0|-0.96|0.18|||ANOVA|||9 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||0.18|-0.96|0.183
72482365|NCT01794923|144492113|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.6||||0.05|TWO_SIDED|95.0|0.0|1.23|||ANOVA|||9 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||1.23|-0.00|0.050
72482366|NCT01794923|144492113|SUPERIORITY_OR_OTHER_LEGACY|||||||0.221|TWO_SIDED||||||ANOVA|||10 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||||0.221
72482367|NCT01794923|144492113|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.2||||0.526|TWO_SIDED|95.0|-0.4|0.79|||ANOVA|||10 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||0.79|-0.40|0.526
72482368|NCT01794923|144492113|SUPERIORITY_OR_OTHER_LEGACY||LS mean Difference|-0.4||||0.232|TWO_SIDED|95.0|-0.96|0.23|||ANOVA|||10 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||0.23|-0.96|0.232
72482369|NCT01794923|144492113|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.6||||0.089|TWO_SIDED|95.0|-0.08|1.19|||ANOVA|||10 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||1.19|-0.08|0.089
72566953|NCT03020719|144664555|SUPERIORITY||Difference in % of Participants with SAE|-13.3||||0.1945|TWO_SIDED|95.0|-30.5|2.9|||Fisher Exact||95% CI calculated using the Newcombe-Wilson method without continuity correction.|||2.9|-30.5|0.1945
72482370|NCT01794923|144492113|SUPERIORITY_OR_OTHER_LEGACY|||||||0.19|TWO_SIDED||||||ANOVA|||11 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||||0.190
72482371|NCT01794923|144492113|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.3||||0.365|TWO_SIDED|95.0|-0.31|0.85|||ANOVA|||11 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||0.85|-0.31|0.365
72482372|NCT01794923|144492113|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.3||||0.295|TWO_SIDED|95.0|-0.89|0.27|||ANOVA|||11 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||0.27|-0.89|0.295
72482373|NCT01794923|144492113|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.6||||0.069|TWO_SIDED|95.0|-0.05|1.2|||ANOVA|||11 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||1.20|-0.05|0.069
72482374|NCT01794923|144492113|SUPERIORITY_OR_OTHER_LEGACY|||||||0.197|TWO_SIDED||||||ANOVA|||12 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||||0.197
72566954|NCT03020719|144664556|SUPERIORITY||Rate Ratio|1.21||||0.1087|TWO_SIDED|95.0|0.96|1.52|||Poisson Regression|||Rate Ratio for Adverse Events calculated using Poisson Regression with an offset for the log of follow-up time in months. The total number of follow-up months of all participants (not per participant) in the trial was as follows: in the GSH group was 179.22 and in the Placebo group was 177.19.||1.52|0.96|0.1087
72566955|NCT03020719|144664556|SUPERIORITY||Rate Ratio|0.12||||0.0122|TWO_SIDED|95.0|0.01|0.67|||Poisson Regression|||Rate Ratio for Serious Adverse Events calculated using Poisson Regression with an offset for the log of follow-up time in months. The total number of follow-up months of all participants (not per participant) in the trial was as follows: in the GSH group was 179.22 and in the Placebo group was 177.19.||0.67|0.01|0.0122
72566956|NCT00515034|144664558|NON_INFERIORITY_OR_EQUIVALENCE|Percent of participants who are clinically cured including 95% confidence intervals are provided.|Risk Difference (RD)|-13.8|||||TWO_SIDED|95.0|-54.4|26.8|||normal approximation to the binomial||Treatment difference (doripenem minus imipenem/cilastatin) in percent of participants who are clinically cured.|There is no formal hypothesis test for this outcome. Only summary data are provided.||26.8|-54.4|
72566957|NCT00515034|144664559|NON_INFERIORITY_OR_EQUIVALENCE|Percent of participants who are clinically cured including 95% confidence intervals are provided.|Risk Difference (RD)|18.7|||||TWO_SIDED|95.0|-13.2|50.6|||normal approximation to binomial||Treatment difference (doripenem minus imipenem) in percent of participants who are clinically cured.|There is no formal hypothesis test for this outcome. Only summary data are presented.||50.6|-13.2|
72566958|NCT01392326|144664565|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.53|||<|0.0001|TWO_SIDED|95.0|3.46|8.85|||Regression, Logistic|||||8.85|3.46|<0.0001
72566959|NCT01392326|144664565|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.39|||<|0.0001|TWO_SIDED|95.0|3.37|8.62|||Regression, Logistic|||||8.62|3.37|<0.0001
72402078|NCT02515942|144311356|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-0.28||||0.4454|TWO_SIDED|80.0|-2.89|2.33|||Mixed Models Analysis|||Change from baseline at Day 2||2.33|-2.89|0.4454
72482375|NCT01794923|144492113|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.3||||0.309|TWO_SIDED|95.0|-0.29|0.92|||ANOVA|||12 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||0.92|-0.29|0.309
72482376|NCT01794923|144492113|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.3||||0.359|TWO_SIDED|95.0|-0.89|0.33|||ANOVA|||12 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||0.33|-0.89|0.359
72482377|NCT01794923|144492113|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.6||||0.072|TWO_SIDED|95.0|-0.05|1.25|||ANOVA|||12 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||1.25|-0.05|0.072
72482378|NCT01794923|144492113|SUPERIORITY_OR_OTHER_LEGACY|||||||0.151|TWO_SIDED||||||ANOVA|||24 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||||0.151
72482379|NCT01794923|144492113|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.6||||0.09|TWO_SIDED|95.0|-0.1|1.32|||ANOVA|||24 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||1.32|-0.10|0.090
72482380|NCT01794923|144492113|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.1||||0.889|TWO_SIDED|95.0|-0.76|0.66|||ANOVA|||24 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||0.66|-0.76|0.889
72482381|NCT01794923|144492113|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.7||||0.088|TWO_SIDED|95.0|-0.1|1.42|||ANOVA|||24 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||1.42|-0.10|0.088
72482382|NCT01794923|144492113|SUPERIORITY_OR_OTHER_LEGACY|||||||0.673|TWO_SIDED||||||ANOVA|||30 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||||0.673
72482383|NCT01794923|144492113|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.3||||0.393|TWO_SIDED|95.0|-0.41|1.04|||ANOVA|||30 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||1.04|-0.41|0.393
72482384|NCT01794923|144492113|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.1||||0.887|TWO_SIDED|95.0|-0.67|0.78|||ANOVA|||30 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||0.78|-0.67|0.887
72482385|NCT01794923|144492113|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.3||||0.507|TWO_SIDED|95.0|-0.51|1.04|||ANOVA|||30 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||1.04|-0.51|0.507
72482386|NCT01794923|144492113|SUPERIORITY_OR_OTHER_LEGACY|||||||0.873|TWO_SIDED||||||ANOVA|||36 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||||0.873
72482387|NCT01794923|144492113|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.2||||0.605|TWO_SIDED|95.0|-0.58|1.0|||ANOVA|||36 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||1.00|-0.58|0.605
72482388|NCT01794923|144492113|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.1||||0.86|TWO_SIDED|95.0|-0.72|0.86|||ANOVA|||26 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||0.86|-0.72|0.860
72482389|NCT01794923|144492113|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.1||||0.751|TWO_SIDED|95.0|-0.71|0.98|||ANOVA|||36 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||0.98|-0.71|0.751
72482390|NCT01794923|144492113|SUPERIORITY_OR_OTHER_LEGACY|||||||0.528|TWO_SIDED||||||ANOVA|||48 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||||0.528
72482391|NCT01794923|144492113|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.3||||0.486|TWO_SIDED|95.0|-1.09|0.52|||ANOVA|||48 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||0.52|-1.09|0.486
72482392|NCT01794923|144492113|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.2||||0.61|TWO_SIDED|95.0|-0.6|1.02|||ANOVA|||48 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||1.02|-0.60|0.610
72482393|NCT01794923|144492113|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.5||||0.261|TWO_SIDED|95.0|-1.36|0.37|||ANOVA|||48 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||0.37|-1.36|0.261
72482394|NCT01794923|144492113|SUPERIORITY_OR_OTHER_LEGACY|||||||0.943|TWO_SIDED||||||ANOVA|||54 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||||0.943
72482395|NCT01794923|144492113|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.1||||0.733|TWO_SIDED|95.0|-0.96|0.68|||ANOVA|||54 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||0.68|-0.96|0.733
72482396|NCT01794923|144492113|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.1||||0.902|TWO_SIDED|95.0|-0.87|0.77|||ANOVA|||54 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||0.77|-0.87|0.902
72482397|NCT01794923|144492113|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.1||||0.84|TWO_SIDED|95.0|-0.97|0.79|||ANOVA|||54 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||0.79|-0.97|0.840
72482398|NCT01794923|144492113|SUPERIORITY_OR_OTHER_LEGACY|||||||0.758|TWO_SIDED||||||ANOVA|||60 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||||0.758
72482399|NCT01794923|144492113|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.3||||0.493|TWO_SIDED|95.0|-1.12|0.54|||ANOVA|||60 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||0.54|-1.12|0.493
72482400|NCT01794923|144492113|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.0||||0.974|TWO_SIDED|95.0|-0.84|0.82|||ANOVA|||60 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||0.82|-0.84|0.974
72510983|NCT03280550|144552346|SUPERIORITY||Difference in Least Squares Means|-0.43|STANDARD_ERROR_OF_MEAN|0.14||0.0023|TWO_SIDED|95.0|-0.7|-0.16||Tested at the two-sided 0.05 significance level.|Mixed-Effect Model of Repeated Measures|Adjustments: geographic region, asthma/aspirin sensitivity, treatment, timepoint, baseline ARS, treatment and baseline ARS by timepoint interactions.|Difference in least squares means: Omalizumab arm minus Placebo arm.|The null hypothesis was that no difference exists between the treatment groups for change from baseline in the average daily Anterior Rhinorrhea Score (ARS) at Week 24.||-0.16|-0.70|0.0023
72510984|NCT03280550|144552347|SUPERIORITY||Odds Ratio (OR)|0.61||||0.6716|TWO_SIDED|95.0|0.05|5.51||Tested at the two-sided 0.05 significance level.|Fisher Exact|Unadjusted|Odds ratio is comparing Omalizumab arm to Placebo arm.|The null hypothesis was that no difference exists between the treatment groups for requirement of rescue medication through Week 24.||5.51|0.05|0.6716
72510985|NCT03280550|144552348|SUPERIORITY||Odds Ratio (OR)|0.0||||0.4815|TWO_SIDED|95.0|0.0|17.64||Tested at the two-sided 0.05 significance level.|Fisher Exact|Unadjusted|Odds ratio is comparing Omalizumab arm to Placebo arm.|The null hypothesis was that no difference exists between the treatment groups for having had surgery for nasal polyps through Week 24.||17.64|0.00|0.4815
72510986|NCT03280550|144552349|SUPERIORITY||Odds Ratio (OR)|3.71||||0.0492|TWO_SIDED|95.0|1.0|13.71|||Wald Chi-Square|Adjusted for Baseline AQLQ, geographic region, and aspirin sensitivity status.|Odds ratio is comparing Omalizumab arm to Placebo arm.|The null hypothesis was that no difference exists between the treatment groups for number of participants with a change from baseline in AQLQ score of ≥0.5 at Week 24.||13.71|1.00|0.0492
72510987|NCT03280550|144552350|SUPERIORITY||Odds Ratio (OR)|0.61||||0.6716|TWO_SIDED|95.0|0.05|5.51||Tested at the two-sided 0.05 significance level.|Fisher Exact|Unadjusted|Odds ratio is comparing Omalizumab arm to Placebo arm.|The null hypothesis was that no difference exists between the treatment groups for requirement of rescue treatment through Week 24.||5.51|0.05|0.6716
72510988|NCT03280550|144552351|SUPERIORITY||Odds Ratio (OR)|6.25||||0.0209|TWO_SIDED|95.0|1.32|29.6||Tested at the two-sided 0.05 significance level.|Wald Chi-Square|Adjusted for geographic region and asthma/aspirin sensitivity comorbidity status.|Odds ratio is comparing Omalizumab arm to Placebo arm.|The null hypothesis was that no difference exists between the treatment groups for change from baseline in reduction in the need for surgery for nasal polyps by Week 24.||29.60|1.32|0.0209
72510989|NCT03280550|144552352|SUPERIORITY||Difference in Least Squares Means|-1.91|STANDARD_ERROR_OF_MEAN|0.48||0.0001|TWO_SIDED|95.0|-2.85|-0.96||Tested at the two-sided 0.05 significance level.|Mixed-Effect Model of Repeated Measures|Adjustments: geographic region, asthma/aspirin sensitivity, treatment, timepoint, baseline TNSS, treatment and baseline by timepoint interactions.|Difference in least squares means: Omalizumab arm minus Placebo arm.|The null hypothesis was that no difference exists between the treatment groups for change from baseline in the average daily Total Nasal Symptom Score (TNSS) at Week 24.||-0.96|-2.85|0.0001
72510990|NCT03280550|144552353|SUPERIORITY||Difference in Least Squares Means|3.81|STANDARD_ERROR_OF_MEAN|1.23||0.0024|TWO_SIDED|95.0|1.38|6.24||Tested at the two-sided 0.05 significance level.|Mixed-Effect Model of Repeated Measures|Adjustments: geographic region, asthma/aspirin sensitivity, treatment, timepoint, baseline UPSIT, treatment and baseline by timepoint interactions.|Difference in least squares means: Omalizumab arm minus Placebo arm|The null hypothesis was that no difference exists between the treatment groups for change from baseline in the UPSIT score at Week 24.||6.24|1.38|0.0024
72510991|NCT01943864|144552377|SUPERIORITY_OR_OTHER||non PD rate at Week 12|10.0||||0.976|TWO_SIDED|95.0|1.2|31.7|||Exact Binomial Test|||||31.7|1.2|0.976
72510992|NCT01943864|144552378|SUPERIORITY_OR_OTHER||non PD rate at Week 12|15.0||||0.909|TWO_SIDED|95.0|3.2|37.9|||Exact Binomial Test|||||37.9|3.2|0.909
72510993|NCT01943864|144552393|SUPERIORITY_OR_OTHER||Median PFS|10.6|||||TWO_SIDED|95.0|4.6|12.1|||||Lower and upper limits and estimation value are in terms of weeks|||12.1|4.6|
72510994|NCT01943864|144552394|SUPERIORITY_OR_OTHER||Median PFS|10.6|||||TWO_SIDED|95.0|4.6|12.7|||||Lower and upper limits and estimation value are in terms of weeks|||12.7|4.6|
72510995|NCT01943864|144552395|SUPERIORITY_OR_OTHER||Overall Survival|20.0|||||TWO_SIDED|95.0|6.2|39.3||||||||39.3|6.2|
72510996|NCT01943864|144552396|SUPERIORITY_OR_OTHER||ORR|0.0|||||TWO_SIDED|95.0|0.0|16.8||||||||16.8|0|
72510997|NCT01943864|144552397|SUPERIORITY_OR_OTHER||ORR|5.0|||||TWO_SIDED|95.0|0.1|24.9||||||||24.9|0.1|
72510998|NCT01067508|144552408|OTHER|||||||0.003||||||p\<0.05 was defined as significant|t-test, 2 sided|||Comparison was made to 12 weeks minus baseline change in Fiji water group||||0.003
72510999|NCT01067508|144552408|OTHER|||||||0.68||||||p\<0.05 was defined as significant|t-test, 2 sided|||Comparison was made to the 12 week minus baseline change in Aquafina (control) group||||0.68
72511000|NCT04594239|144552429|SUPERIORITY||Difference in response rates|78.7|||||TWO_SIDED|95.0|66.3|85.6||||||||85.6|66.3|
72511001|NCT04594239|144552429|SUPERIORITY||Difference in response rates|85.4|||||TWO_SIDED|95.0|70.5|92.3||||||||92.3|70.5|
72511002|NCT04594239|144552429|SUPERIORITY||Difference in response rates|71.8|||||TWO_SIDED|95.0|55.2|82.5||||||||82.5|55.2|
72511003|NCT00091390|144552435|SUPERIORITY_OR_OTHER_LEGACY||hazard rate|0.0014|||<|0.0001|TWO_SIDED|95.0|0.0|0.003|||Z-test|One-sided.||The study is designed to test whether the 18-month late GU/GI toxicity following the protocol treatment is above 10% (hazard rate of 0.012/month). The sample size is determined so that the probability of rejecting the treatment because of excessive late toxicity is 90% if the true late toxicity rate is 20% (hazard rate of 0.025/month). Ninety-eight patients are required to with an additional 18 months of follow-up to have a statistical power of 90% with one-sided significance level of 0.05.||0.003|0|<0.0001
72511004|NCT00335504|144552502|SUPERIORITY_OR_OTHER|||||||0.3||95.0||||Adjusting for multiple comparisons yields 84% power to detect a difference of at least 25% in % change of ACF at the 0.016 level of significance and using a two-sample, 2-sided t-test.|Wilcoxon (Mann-Whitney)|||The study was designed to test the hypotheses of observing a 25% difference in % change ACF over baseline, between patients treated with atorvastatin compared to placebo. N=25 subjects per group yielded 93% power to detect this difference using a 2 sided t-test at significance level of 0.05. Non-parametric tests (eg, Wilcoxon Rank Sum) could be used if the statistical assumptions of the t-test were violated.||||0.30
72402079|NCT02515942|144311356|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|2.46||||0.8861|TWO_SIDED|80.0|-0.16|5.08|||Mixed Models Analysis|||Change from baseline at Day 2||5.08|-0.16|0.8861
72402080|NCT02515942|144311356|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|1.16||||0.713|TWO_SIDED|80.0|-1.49|3.8|||Mixed Models Analysis|||Change from baseline at Day 29||3.80|-1.49|0.7130
72624023|NCT02231580|144778429|SUPERIORITY_OR_OTHER||GLS mean ratio|0.879|||=|0.1244|TWO_SIDED|90.0|0.765|1.009|||MMRM|||Left hand freq statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||1.009|0.765|=0.1244
72402081|NCT02515942|144311356|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|2.37||||0.8759|TWO_SIDED|80.0|-0.26|5.01|||Mixed Models Analysis|||Change from baseline at Day 29||5.01|-0.26|0.8759
72482401|NCT01794923|144492113|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.3||||0.543|TWO_SIDED|95.0|-1.16|0.61|||ANOVA|||60 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||0.61|-1.16|0.543
72482402|NCT01794923|144492113|SUPERIORITY_OR_OTHER_LEGACY|||||||0.238|TWO_SIDED||||||ANOVA|||72 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||||0.238
72482403|NCT01794923|144492113|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.7||||0.106|TWO_SIDED|95.0|-1.46|0.14|||ANOVA|||72 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||0.14|-1.46|0.106
72482404|NCT01794923|144492113|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.1||||0.817|TWO_SIDED|95.0|-0.9|0.71|||ANOVA|||72 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||0.71|-0.90|0.817
72482405|NCT01794923|144492113|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.6||||0.197|TWO_SIDED|95.0|-1.43|0.3|||ANOVA|||72 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||0.30|-1.43|0.197
72482406|NCT01794923|144492114|SUPERIORITY_OR_OTHER_LEGACY|||||||0.702|TWO_SIDED||||||ANOVA|||0-24 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline spontaneous muscle soreness (SMS) terms.||||0.702
72482407|NCT01794923|144492114|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|2.8||||0.664|TWO_SIDED|95.0|-9.91|15.53|||ANOVA|||0-24 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline spontaneous muscle soreness (SMS) terms.||15.53|-9.91|0.664
72482408|NCT01794923|144492114|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-3.0||||0.637|TWO_SIDED|95.0|-15.77|9.68|||ANOVA|||0-24 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline spontaneous muscle soreness (SMS) terms.||9.68|-15.77|0.637
72482409|NCT01794923|144492114|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|5.9||||0.401|TWO_SIDED|95.0|-7.85|19.57|||ANOVA|||0-24 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||19.57|-7.85|0.401
72482410|NCT01794923|144492114|SUPERIORITY_OR_OTHER_LEGACY|||||||0.926|TWO_SIDED||||||ANOVA|||24-48 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline spontaneous muscle soreness (SMS) terms.||||0.926
72482411|NCT01794923|144492114|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-4.2||||0.743|TWO_SIDED|95.0|-29.51|21.1|||ANOVA|||24-48 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline spontaneous muscle soreness (SMS) terms.||21.10|-29.51|0.743
72482412|NCT01794923|144492114|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.8||||0.952|TWO_SIDED|95.0|-24.55|26.08|||ANOVA|||24-48 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline spontaneous muscle soreness (SMS) terms.||26.08|-24.55|0.952
72482413|NCT01794923|144492114|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-5.0||||0.719|TWO_SIDED|95.0|-32.25|22.3|||ANOVA|||24-48 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline spontaneous muscle soreness (SMS) terms.||22.30|-32.25|0.719
72482414|NCT01794923|144492114|SUPERIORITY_OR_OTHER_LEGACY|||||||0.284|TWO_SIDED||||||ANOVA|||48-72 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline spontaneous muscle soreness (SMS) terms.||||0.284
72482415|NCT01794923|144492114|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-19.0||||0.171|TWO_SIDED|95.0|-46.21|8.28|||ANOVA|||48-72 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline spontaneous muscle soreness (SMS) terms.||8.28|-46.21|0.171
72482416|NCT01794923|144492114|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|2.2||||0.875|TWO_SIDED|95.0|-25.08|29.42|||ANOVA|||48-72 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline spontaneous muscle soreness (SMS) terms.||29.42|-25.08|0.875
72482417|NCT01794923|144492114|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-21.1||||0.157|TWO_SIDED|95.0|-50.5|8.23|||ANOVA|||48-72 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||8.23|-50.50|0.157
72482418|NCT01794923|144492114|SUPERIORITY_OR_OTHER_LEGACY|||||||0.699|TWO_SIDED||||||ANOVA|||0-72 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline spontaneous muscle soreness (SMS) terms.||||0.699
72482419|NCT01794923|144492114|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-17.8||||0.433|TWO_SIDED|95.0|-62.58|26.9|||ANOVA|||0-72 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline spontaneous muscle soreness (SMS) terms.||26.90|-62.58|0.433
72402082|NCT02515942|144311356|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|1.22||||0.7256|TWO_SIDED|80.0|-1.39|3.82|||Mixed Models Analysis|||Change from baseline at Day 29||3.82|-1.39|0.7256
72511005|NCT00335504|144552502|SUPERIORITY_OR_OTHER|||||||0.6||95.0||||Adjusting for multiple comparisons yields 84% power to detect a difference of at least 25% in % change of ACF at the 0.016 level of significance and using a two-sample, 2-sided t-test.|Wilcoxon (Mann-Whitney)|||The study was designed to test the hypotheses of observing a 25% difference in % change ACF over baseline, between patients treated with sulindac compared to placebo. N=25 subjects per group yielded 93% power to detect this difference using a 2 sided t-test at significance level of 0.05. Non-parametric tests (eg, Wilcoxon Rank Sum) could be used if the statistical assumptions of the t-test were violated.||||0.60
72511006|NCT00335504|144552502|SUPERIORITY_OR_OTHER|||||||0.92||95.0||||Adjusting for multiple comparisons yields 84% power to detect a difference of at least 25% in % change of ACF at the 0.016 level of significance and using a two-sample, 2-sided t-test.|Wilcoxon (Mann-Whitney)|||The study was designed to test the hypotheses of observing a 25% difference in % change ACF over baseline, between patients treated with oligofructose-enriched inulin compared to placebo. N=25 subjects per group yielded 93% power to detect this difference using a 2 sided t-test at significance level of 0.05. Non-parametric tests (eg, Wilcoxon Rank Sum) could be used if the statistical assumptions of the t-test were violated.||||0.92
72511007|NCT00335504|144552502|SUPERIORITY_OR_OTHER|||||||0.59||95.0|||||Sign test|||Signed Rank p-value for comparison of % change in ACF within each randomization arm.||||0.59
72511008|NCT00335504|144552502|SUPERIORITY_OR_OTHER|||||||0.12||95.0|||||Sign test|||Signed Rank p-value for comparison of % change in ACF within each randomization arm.||||0.12
72511009|NCT00335504|144552502|SUPERIORITY_OR_OTHER|||||||0.54||95.0|||||Sign test|||Signed Rank p-value for comparison of % change in ACF within each randomization arm.||||0.54
72402083|NCT02515942|144311356|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-1.17||||0.3111|TWO_SIDED|80.0|-4.22|1.88|||Mixed Models Analysis|||Change from baseline at Day 57||1.88|-4.22|0.3111
72402084|NCT02515942|144311356|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-1.7||||0.236|TWO_SIDED|80.0|-4.73|1.34|||Mixed Models Analysis|||Change from baseline at Day 57||1.34|-4.73|0.2360
72402085|NCT02515942|144311356|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-0.53||||0.411|TWO_SIDED|80.0|-3.55|2.49|||Mixed Models Analysis|||Change from baseline at Day 57||2.49|-3.55|0.4110
72402086|NCT02515942|144311356|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|0.13||||0.5247|TWO_SIDED|80.0|-2.57|2.83|||Mixed Models Analysis|||Change from baseline at Day 85||2.83|-2.57|0.5247
72511010|NCT00335504|144552502|SUPERIORITY_OR_OTHER|||||||0.41||95.0|||||Sign test|||Signed Rank p-value for comparison of % change in ACF within each randomization arm.||||0.41
72511011|NCT00335504|144552503|SUPERIORITY_OR_OTHER|||||||0.37||95.0|||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum p-value for comparison of % change in Ki67 between atorvastatin and placebo.||||0.37
72402087|NCT02515942|144311356|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-3.37||||0.0534|TWO_SIDED|80.0|-6.04|-0.7|||Mixed Models Analysis|||Change from baseline at Day 85||-0.70|-6.04|0.0534
72402088|NCT02515942|144311356|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-3.5||||0.0475|TWO_SIDED|80.0|-6.18|-0.82|||Mixed Models Analysis|||Change from baseline at Day 85||-0.82|-6.18|0.0475
72511012|NCT00335504|144552503|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum p-value for comparison of % change in Ki67 between sulindac and placebo.||||1.00
72511013|NCT00335504|144552503|SUPERIORITY_OR_OTHER|||||||0.58||95.0|||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum p-value for comparison of % change in Ki67 between oligofructose-enriched inulin and placebo.||||0.58
72511014|NCT00335504|144552504|SUPERIORITY_OR_OTHER|||||||0.26||95.0|||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum p-value for comparison of % change in apoptosis between atorvastatin calcium and placebo.||||0.26
72511015|NCT00335504|144552504|SUPERIORITY_OR_OTHER|||||||0.88||95.0|||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum p-value for comparison of % change in apoptosis between sulindac and placebo.||||0.88
72511016|NCT00335504|144552504|SUPERIORITY_OR_OTHER|||||||0.38||95.0|||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum p-value for comparison of % change in apoptosis between oligofructose-enriched inulin and placebo.||||0.38
72511017|NCT01718509|144552506|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-1.66|||<|0.001|TWO_SIDED|95.0|-2.04|-1.28|||Mixed Models Repeated Measures Analysis|||||-1.28|-2.04|<0.001
72511018|NCT01718509|144552507|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Chi-squared|||||||<0.001
72402089|NCT02515942|144311356|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-3.92||||0.0575|TWO_SIDED|80.0|-7.11|-0.74|||Mixed Models Analysis|||Change from baseline at Day 113||-0.74|-7.11|0.0575
72511019|NCT01718509|144552508|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Chi-squared|||||||<0.001
72511020|NCT01718509|144552509|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-5.41|||<|0.001|TWO_SIDED|95.0|-6.39|-4.44|||Mixed Models Repeated Measures Analysis|||||-4.44|-6.39|<0.001
72511021|NCT01718509|144552510|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-7.94|||<|0.001|TWO_SIDED|95.0|-9.51|-6.36|||Mixed Models Repeated Measures Analysis|||||-6.36|-9.51|<0.001
72511022|NCT01718509|144552511|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.196||||0.002|TWO_SIDED|95.0|-0.321|-0.07|||ANCOVA|||||-0.070|-0.321|0.002
72511023|NCT01718509|144552512|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.077||||0.234|TWO_SIDED|95.0|-0.205|0.05|||ANCOVA|||||0.050|-0.205|0.234
72511024|NCT01718509|144552513|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|0.03||||0.185|TWO_SIDED|95.0|-0.02|0.08|||ANCOVA|||||0.08|-0.02|0.185
72511025|NCT01718509|144552514|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||Multiplicity is not adjusted for this secondary efficacy endpoint in this study.|Cochran-Mantel-Haenszel|||||||<0.001
72511026|NCT01718509|144552515|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-2.23|||<|0.001|TWO_SIDED|95.0|-2.77|-1.69||Multiplicity is not adjusted for this secondary efficacy endpoint in this study.|Mixed Models Repeated Measures Analysis|||||-1.69|-2.77|<0.001
72511027|NCT01718509|144552516|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|1.27||||0.011|TWO_SIDED|95.0|0.29|2.24||Multiplicity is not adjusted for this secondary efficacy endpoint in this study.|Mixed Models Repeated Measures Analysis|||Cognitive Restraint of Eating||2.24|0.29|0.011
72511028|NCT01718509|144552516|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-3.6|||<|0.001|TWO_SIDED|95.0|-4.44|-2.76||Multiplicity is not adjusted for this secondary efficacy endpoint in this study.|Mixed Models Repeated Measures Analysis|||Disinhibition of Eating||-2.76|-4.44|<0.001
72511029|NCT01718509|144552516|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-4.21|||<|0.001|TWO_SIDED|95.0|-5.09|-3.33||Multiplicity is not adjusted for this secondary efficacy endpoint in this study.|Mixed Models Repeated Measures Analysis|||Perceived Hunger||-3.33|-5.09|<0.001
72511030|NCT01718509|144552517|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-9.28|||<|0.001|TWO_SIDED|95.0|-11.44|-7.12||Multiplicity is not adjusted for this secondary efficacy endpoint in this study.|Mixed Models Repeated Measures Analysis|||||-7.12|-11.44|<0.001
72511031|NCT01718509|144552518|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.96||||0.298|TWO_SIDED|95.0|-2.77|0.85||Multiplicity is not adjusted for this secondary efficacy endpoint in this study.|ANCOVA|||||0.85|-2.77|0.298
72511032|NCT05209932|144552526|EQUIVALENCE|Testing the equivalence of the means using two-tailed test.|Mean Difference (Net)|-0.17|STANDARD_ERROR_OF_MEAN|0.07||0.02|TWO_SIDED||||||ANCOVA|||||||0.02
72511033|NCT05209932|144552527|EQUIVALENCE|Testing the equivalence of the means using two-tailed test.|Mean Difference (Net)|-0.11|STANDARD_ERROR_OF_MEAN|0.06||0.05|TWO_SIDED||||||ANCOVA|||||||0.05
72511034|NCT05209932|144552528|EQUIVALENCE|Testing the equivalence of the means using two-tailed test.|Mean Difference (Net)|0.13|STANDARD_ERROR_OF_MEAN|0.07||0.07|TWO_SIDED||||||ANCOVA|||||||0.07
72511035|NCT05209932|144552529|EQUIVALENCE|Testing the equivalence of the means using two-tailed test.|Mean Difference (Net)|0.17|STANDARD_ERROR_OF_MEAN|0.12||0.17|TWO_SIDED||||||ANCOVA|||||||0.17
72511036|NCT05209932|144552530|EQUIVALENCE|Testing the equivalence of the means using two-tailed test.|Mean Difference (Final Values)|-0.22|STANDARD_ERROR_OF_MEAN|0.07||0.002|TWO_SIDED||||||ANCOVA|||||||0.002
72511037|NCT05209932|144552531|EQUIVALENCE|Testing the equivalence of the means using two-tailed test.|Mean Difference (Net)|-0.22|STANDARD_ERROR_OF_MEAN|0.1||0.03|TWO_SIDED||||||ANCOVA|||||||0.03
72511038|NCT05209932|144552532|EQUIVALENCE|Testing the equivalence of the means using two-tailed test.|Mean Difference (Net)|0.22|STANDARD_ERROR_OF_MEAN|0.09||0.01|TWO_SIDED||||||ANCOVA|||||||0.01
72511039|NCT05209932|144552533|EQUIVALENCE|Testing the equivalence of the means using two-tailed test.|Mean Difference (Net)|0.38|STANDARD_ERROR_OF_MEAN|0.19||0.04|TWO_SIDED||||||ANCOVA|||||||0.04
72511040|NCT05209932|144552534|EQUIVALENCE|Testing the equivalence of the means using two-tailed test.|Mean Difference (Net)|0.22|STANDARD_ERROR_OF_MEAN|0.1||0.02|TWO_SIDED||||||ANCOVA|||||||0.02
72511041|NCT05209932|144552535|EQUIVALENCE|Testing the equivalence of the means using two-tailed test.|Mean Difference (Net)|0.4|STANDARD_ERROR_OF_MEAN|0.13||0.002|TWO_SIDED||||||ANCOVA|||||||0.002
72511042|NCT05209932|144552536|EQUIVALENCE|Testing the equivalence of the means using two-tailed test.|Mean Difference (Net)|0.08|STANDARD_ERROR_OF_MEAN|0.1||0.43|TWO_SIDED||||||ANCOVA|||||||0.43
72511043|NCT05209932|144552537|EQUIVALENCE|Testing the equivalence of the means using two-tailed test.|Mean Difference (Net)|0.22|STANDARD_ERROR_OF_MEAN|0.14||0.12|TWO_SIDED||||||ANCOVA|||||||0.12
72511044|NCT05209932|144552538|EQUIVALENCE|Testing the equivalence of the means using two-tailed test.|Mean Difference (Net)|0.17|STANDARD_ERROR_OF_MEAN|0.08||0.03|TWO_SIDED||||||ANCOVA|||||||0.03
72511045|NCT05209932|144552539|EQUIVALENCE|Testing the equivalence of the means using two-tailed test.|Mean Difference (Net)|-0.06|STANDARD_ERROR_OF_MEAN|0.13||0.63|TWO_SIDED||||||ANCOVA|||||||0.63
72566960|NCT02508259|144664583|EQUIVALENCE|The null hypothesis was that before and after treatment ADOS scores were equivalent.|Mean Difference (Net)|-1.6|STANDARD_DEVIATION|0.55||0.0028|TWO_SIDED|95.0|-2.3|-0.9|||t-test, 2 sided|||In this analysis, each child was used as their own control to examine before and after suramin treatment effects in a paired t-test design. This study was a small pilot study of safety and activity of suramin. The small subject numbers of just 5 per group make it impossible to draw any strong conclusions about efficacy. Future studies are required.||-0.9|-2.3|0.0028
72566961|NCT02508259|144664584|EQUIVALENCE|The child-specific difference in EOWPVT scores were compared for equivalence before and 6-weeks after suramin treatment|Mean Difference (Net)|-4.2|STANDARD_DEVIATION|8.3||0.32|TWO_SIDED|95.0|-14.5|6.1|||t-test, 2 sided|||In this analysis, each child was used as their own control to examine before and after suramin treatment effects in a paired t-test design. This study was a small pilot study of safety and activity of suramin. The small subject numbers of just 5 per group make it impossible to draw any strong conclusions about efficacy. Future studies are required.||6.1|-14.5|0.32
72566962|NCT02508259|144664585|EQUIVALENCE|In this analysis, the null hypothesis was tested that the child-specific ABC subscores for stereotypy were unchanged before and after suramin treatment.|Mean Difference (Net)|-4.0|STANDARD_DEVIATION|2.3||0.019|TWO_SIDED|95.0|-6.9|-1.1|||t-test, 2 sided|||In this analysis, each child was used as their own control to examine before and after suramin treatment effects in a paired t-test design. This study was a small pilot study of safety and activity of suramin. The small subject numbers of just 5 per group make it impossible to draw any strong conclusions about efficacy. Future studies are required.||-1.1|-6.9|0.019
72566963|NCT02508259|144664586|EQUIVALENCE|In this analysis, we tested the equivalence of the child-specific ATEC subscore for language before and 6-weeks after treatment with suramin.|Mean Difference (Net)|-2.0|STANDARD_DEVIATION|1.4||0.034|TWO_SIDED|95.0|-2.7|-0.49|||t-test, 2 sided|||In this analysis, each child was used as their own control to examine before and after suramin treatment effects in a paired t-test design. This study was a small pilot study of safety and activity of suramin. The small subject numbers of just 5 per group make it impossible to draw any strong conclusions about efficacy. Future studies are required.||-0.49|-2.7|0.034
72566964|NCT02508259|144664587|EQUIVALENCE|In this analysis, overall ASD symptom scores, measured by CGI were compared between suramin and placebo groups.|Mean Difference (Final Values)|-1.8|STANDARD_DEVIATION|1.04||0.05|TWO_SIDED|95.0|-3.4|-0.15|||ANOVA|||In this analysis, each child was used as their own control to examine before and after suramin treatment effects in a paired t-test design. This study was a small pilot study of safety and activity of suramin. The small subject numbers of just 5 per group make it impossible to draw any strong conclusions about efficacy. Future studies are required.||-0.15|-3.4|0.05
72402090|NCT02515942|144311356|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-2.16||||0.1876|TWO_SIDED|80.0|-5.29|0.97|||Mixed Models Analysis|||Change from baseline at Day 113||0.97|-5.29|0.1876
72482420|NCT01794923|144492114|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.0||||0.966|TWO_SIDED|95.0|-45.73|43.78|||ANOVA|||0-72 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline spontaneous muscle soreness (SMS) terms.||43.78|-45.73|0.966
72482421|NCT01794923|144492114|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-16.9||||0.491|TWO_SIDED|95.0|-65.08|31.36|||ANOVA|||0-72 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline spontaneous muscle soreness (SMS) terms.||31.36|-65.08|0.491
72482422|NCT01794923|144492115|SUPERIORITY_OR_OTHER_LEGACY|||||||0.219|TWO_SIDED||||||ANOVA|||1 Hour: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||||0.219
72482423|NCT01794923|144492115|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.1||||0.214|TWO_SIDED|95.0|-0.37|0.08|||ANOVA|||1 Hour: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||0.08|-0.37|0.214
72482424|NCT01794923|144492115|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.1||||0.555|TWO_SIDED|95.0|-0.16|0.29|||ANOVA|||1 Hour: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||0.29|-0.16|0.555
72482425|NCT01794923|144492115|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.2||||0.09|TWO_SIDED|95.0|-0.45|0.03|||ANOVA|||1 Hour: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||0.03|-0.45|0.090
72482426|NCT01794923|144492115|SUPERIORITY_OR_OTHER_LEGACY|||||||0.161|TWO_SIDED||||||ANOVA|||2 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||||0.161
72482427|NCT01794923|144492115|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.3||||0.056|TWO_SIDED|95.0|-0.55|0.01|||ANOVA|||2 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||0.01|-0.55|0.056
72482428|NCT01794923|144492115|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.1||||0.395|TWO_SIDED|95.0|-0.4|0.16|||ANOVA|||2 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||0.16|-0.40|0.395
72482429|NCT01794923|144492115|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.1||||0.324|TWO_SIDED|95.0|-0.45|0.15|||ANOVA|||2 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||0.15|-0.45|0.324
72482430|NCT01794923|144492115|SUPERIORITY_OR_OTHER_LEGACY|||||||0.246|TWO_SIDED||||||ANOVA|||3 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||||0.246
72482431|NCT01794923|144492115|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.3||||0.094|TWO_SIDED|95.0|-0.68|0.05|||ANOVA|||3 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||0.05|-0.68|0.094
72511046|NCT05209932|144552540|EQUIVALENCE|Testing the equivalence of the means using two-tailed test.|Mean Difference (Net)|-0.85|STANDARD_ERROR_OF_MEAN|0.8||0.29|TWO_SIDED||||||ANCOVA|||||||0.29
72511047|NCT05209932|144552541|EQUIVALENCE|Testing the equivalence of the means using two-tailed test.|Mean Difference (Net)|-1.08|STANDARD_ERROR_OF_MEAN|1.12||0.33|TWO_SIDED||||||ANCOVA|||||||0.33
72511048|NCT05209932|144552542|EQUIVALENCE|Testing the equivalence of the means using two-tailed test.|Mean Difference (Net)|-2.92|STANDARD_ERROR_OF_MEAN|1.03||0.005|TWO_SIDED||||||ANCOVA|||||||0.005
72511049|NCT05209932|144552543|EQUIVALENCE|Testing the equivalence of the means using two-tailed test.|Mean Difference (Net)|0.07|STANDARD_ERROR_OF_MEAN|0.08||0.42|TWO_SIDED||||||ANCOVA|||||||0.42
72511050|NCT05209932|144552544|EQUIVALENCE|Testing the equivalence of the means using two-tailed test.|Mean Difference (Net)|0.01|STANDARD_ERROR_OF_MEAN|0.3||0.97|TWO_SIDED||||||ANCOVA|||||||0.97
72511051|NCT01728584|144552545|SUPERIORITY_OR_OTHER||Difference in Least Squares (LS) Means|1.09||||0.026|TWO_SIDED|95.0|0.13|2.04|||ANCOVA|Analysis of covariance (ANCOVA) model included factors depth of NMB, level of pressure, surgeon and body mass index (BMI)|Difference is deep versus standard NMB|Primary hypothesis - deep NMB improves surgeon's overall satisfaction with the surgical conditions compared to standard NMB||2.04|0.13|0.026
72511052|NCT01728584|144552545|SUPERIORITY_OR_OTHER||Difference in LS Means|-3.02|||<|0.001|TWO_SIDED|95.0|-3.99|-2.05|||ANCOVA|ANCOVA model included factors depth of NMB, level of pressure, surgeon and BMI|Difference is low versus standard pressure|||-2.05|-3.99|<0.001
72511053|NCT01728584|144552546|SUPERIORITY_OR_OTHER||Difference in Least Squares (LS) Means|3.66|||||TWO_SIDED|95.0|2.3|5.02|||||Difference is standard NMB/standard pressure versus standard NMB/low pressure|ANCOVA model included factors depth of NMB, level of pressure, surgeon and BMI||5.02|2.30|
72511054|NCT01728584|144552546|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.44|||||TWO_SIDED|95.0|-1.8|0.91|||||Difference is standard NMB/standard pressure versus deep NMB/standard pressure|ANCOVA model included factors depth of NMB, level of pressure, surgeon and BMI||0.91|-1.80|
72511055|NCT01728584|144552546|SUPERIORITY_OR_OTHER||Difference in LS Means|1.96|||||TWO_SIDED|95.0|0.57|3.36|||||Difference is standard NMB/standard pressure versus deep NMB/low pressure|ANCOVA model included factors depth of NMB, level of pressure, surgeon and BMI||3.36|0.57|
72511056|NCT01728584|144552546|SUPERIORITY_OR_OTHER||Difference in LS Means|-4.1|||||TWO_SIDED|95.0|-5.42|-2.78|||||Difference is standard NMB/low pressure versus deep NMB/standard pressure|ANCOVA model included factors depth of NMB, level of pressure, surgeon and BMI||-2.78|-5.42|
72511057|NCT01728584|144552546|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.7|||||TWO_SIDED|95.0|-3.01|-0.38|||||Difference is standard NMB/low pressure versus deep NMB/low pressure|ANCOVA model included factors depth of NMB, level of pressure, surgeon and BMI||-0.38|-3.01|
72511058|NCT01728584|144552546|SUPERIORITY_OR_OTHER||Difference in LS Means|2.41|||||TWO_SIDED|95.0|1.08|3.74|||||Difference is deep NMB/standard pressure versus deep NMB/low pressure|ANCOVA model included factors depth of NMB, level of pressure, surgeon and BMI||3.74|1.08|
72511059|NCT01728584|144552547|SUPERIORITY_OR_OTHER||Difference in LS Means|0.35||||0.148|TWO_SIDED|95.0|-0.13|0.84|||ANOVA|Analysis of variance (ANOVA) model included factors depth of NMB, level of pressure, gender and surgeon|Difference is deep versus standard NMB|||0.84|-0.13|0.148
72511060|NCT01728584|144552547|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.17||||0.494|TWO_SIDED|95.0|-0.67|0.33||To control for multiple testing, this difference was formally tested only if comparison of surgeon's overall satisfaction with surgical conditions for deep versus standard NMB was significant at the 5% level, with greater satisfaction for deep NMB.|ANOVA|ANOVA model included factors depth of NMB, level of pressure, gender and surgeon|Difference is low versus standard pressure|Key secondary hypothesis - low insufflation pressure improves overall average pain score in first 24 hours compared to standard insufflation pressure||0.33|-0.67|0.494
72511061|NCT01728584|144552548|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.2|||||TWO_SIDED|95.0|-0.92|0.52|||||Difference is standard NMB/standard pressure versus standard NMB/low pressure|ANOVA model included factors treatment group, gender and surgeon||0.52|-0.92|
72511062|NCT01728584|144552548|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.65|||||TWO_SIDED|95.0|-1.27|-0.02|||||Difference is standard NMB/standard pressure versus deep NMB/standard pressure|ANOVA model included factors treatment group, gender and surgeon||-0.02|-1.27|
72511063|NCT01728584|144552548|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.15|||||TWO_SIDED|95.0|-0.84|0.53|||||Difference is standard NMB/standard pressure versus deep NMB/low pressure|ANOVA model included factors treatment group, gender and surgeon||0.53|-0.84|
72511064|NCT01728584|144552548|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.45|||||TWO_SIDED|95.0|-1.15|0.26|||||Difference is standard NMB/low pressure versus deep NMB/standard pressure|ANOVA model included factors treatment group, gender and surgeon||0.26|-1.15|
72511065|NCT01728584|144552548|SUPERIORITY_OR_OTHER||Difference in LS Means|0.05|||||TWO_SIDED|95.0|-0.69|0.78|||||Difference is standard NMB/low pressure versus deep NMB/low pressure|ANOVA model included factors treatment group, gender and surgeon||0.78|-0.69|
72511066|NCT01728584|144552548|SUPERIORITY_OR_OTHER||Difference in LS Means|0.49|||||TWO_SIDED|95.0|-0.17|1.16|||||Difference is deep NMB/standard pressure versus deep NMB/low pressure|ANOVA model included factors treatment group, gender and surgeon||1.16|-0.17|
72511067|NCT01728584|144552549|SUPERIORITY_OR_OTHER||Difference in LS Means|0.91||||0.063|TWO_SIDED|95.0|-0.05|1.87||Not controlled for multiple testing|ANCOVA|ANCOVA model included factors depth of NMB, level of pressure, surgeon and BMI|Difference is deep versus standard NMB|||1.87|-0.05|0.063
72482432|NCT01794923|144492115|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.1||||0.491|TWO_SIDED|95.0|-0.5|0.24|||ANOVA|||3 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||0.24|-0.50|0.491
72511068|NCT01728584|144552550|SUPERIORITY_OR_OTHER||Difference in LS Means|0.82||||0.004|TWO_SIDED|95.0|0.27|1.37||Not controlled for multiple testing|ANCOVA|ANCOVA model included factors depth of NMB, level of pressure, surgeon and BMI|Difference is deep versus standard NMB|||1.37|0.27|0.004
72511069|NCT01728584|144552551|SUPERIORITY_OR_OTHER||Difference in LS Means|1.12||||0.006|TWO_SIDED|95.0|0.32|1.92||Not controlled for multiple testing|ANCOVA|ANCOVA model included factors depth of NMB, level of pressure, surgeon and BMI|Difference is deep versus standard NMB|||1.92|0.32|0.006
72482433|NCT01794923|144492115|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.2||||0.359|TWO_SIDED|95.0|-0.58|0.21|||ANOVA|||3 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||0.21|-0.58|0.359
72482434|NCT01794923|144492115|SUPERIORITY_OR_OTHER_LEGACY|||||||0.294|TWO_SIDED||||||ANOVA|||4 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||||0.294
72482435|NCT01794923|144492115|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.3||||0.136|TWO_SIDED|95.0|-0.74|0.1|||ANOVA|||4 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||0.10|-0.74|0.136
72511070|NCT01728584|144552552|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.61||||0.073|TWO_SIDED|95.0|-1.27|0.06||Not controlled for multiple testing|ANCOVA|ANCOVA model included factors depth of NMB, level of pressure, surgeon and BMI|Difference is deep versus standard NMB|||0.06|-1.27|0.073
72402091|NCT02515942|144311356|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|1.76||||0.7644|TWO_SIDED|80.0|-1.38|4.91|||Mixed Models Analysis|||Change from baseline at Day 113||4.91|-1.38|0.7644
72402092|NCT02515942|144311356|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-3.85||||0.0838|TWO_SIDED|80.0|-7.42|-0.28|||Mixed Models Analysis|||Change from baseline at Day 141||-0.28|-7.42|0.0838
72482436|NCT01794923|144492115|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.2||||0.293|TWO_SIDED|95.0|-0.65|0.2|||ANOVA|||4 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||0.20|-0.65|0.293
72482437|NCT01794923|144492115|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.1||||0.682|TWO_SIDED|95.0|-0.55|0.36|||ANOVA|||4 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||0.36|-0.55|0.682
72482438|NCT01794923|144492115|SUPERIORITY_OR_OTHER_LEGACY|||||||0.747|TWO_SIDED||||||ANOVA|||5 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||||0.747
72482439|NCT01794923|144492115|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.1||||0.592|TWO_SIDED|95.0|-0.6|0.34|||ANOVA|||5 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||0.34|-0.60|0.592
72482440|NCT01794923|144492115|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.2||||0.473|TWO_SIDED|95.0|-0.64|0.3|||ANOVA|||5 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||0.30|-0.64|0.473
72482441|NCT01794923|144492115|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.0||||0.866|TWO_SIDED|95.0|-0.46|0.55|||ANOVA|||5 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||0.55|-0.46|0.866
72482442|NCT01794923|144492115|SUPERIORITY_OR_OTHER_LEGACY|||||||0.776|TWO_SIDED||||||ANOVA|||6 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||||0.776
72482443|NCT01794923|144492115|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.1||||0.761|TWO_SIDED|95.0|-0.59|0.43|||ANOVA|||6 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||0.43|-0.59|0.761
72511071|NCT01728584|144552553|SUPERIORITY_OR_OTHER||Difference in LS Means|0.74||||0.009|TWO_SIDED|95.0|0.19|1.28||Not controlled for multiple testing|ANCOVA|ANCOVA model included factors depth of NMB, level of pressure, surgeon and BMI|Difference is deep versus standard NMB|||1.28|0.19|0.009
72482444|NCT01794923|144492115|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.2||||0.477|TWO_SIDED|95.0|-0.69|0.33|||ANOVA|||6 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||0.33|-0.69|0.477
72482445|NCT01794923|144492115|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.1||||0.705|TWO_SIDED|95.0|-0.44|0.65|||ANOVA|||6 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||0.65|-0.44|0.705
72482446|NCT01794923|144492115|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6|TWO_SIDED||||||ANOVA|||7 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||||0.600
72482447|NCT01794923|144492115|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.0||||0.931|TWO_SIDED|95.0|-0.52|0.56|||ANOVA|||7 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||0.56|-0.52|0.931
72482448|NCT01794923|144492115|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.2||||0.381|TWO_SIDED|95.0|-0.78|0.3|||ANOVA|||7 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||0.30|-0.78|0.381
72482449|NCT01794923|144492115|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.3||||0.371|TWO_SIDED|95.0|-0.32|0.85|||ANOVA|||7 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||0.85|-0.32|0.371
72482450|NCT01794923|144492115|SUPERIORITY_OR_OTHER_LEGACY|||||||0.67|TWO_SIDED||||||ANOVA|||8 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||||0.670
72482451|NCT01794923|144492115|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.0||||0.941|TWO_SIDED|95.0|-0.54|0.58|||ANOVA|||8 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||0.58|-0.54|0.941
72482452|NCT01794923|144492115|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.2||||0.437|TWO_SIDED|95.0|-0.78|0.34|||ANOVA|||8 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||0.34|-0.78|0.437
72482453|NCT01794923|144492115|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.2||||0.429|TWO_SIDED|95.0|-0.36|0.84|||ANOVA|||8 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||0.84|-0.36|0.429
72482454|NCT01794923|144492115|SUPERIORITY_OR_OTHER_LEGACY|||||||0.484|TWO_SIDED||||||ANOVA|||9 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||||0.484
72482455|NCT01794923|144492115|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.2||||0.504|TWO_SIDED|95.0|-0.38|0.78|||ANOVA|||9 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||0.78|-0.38|0.504
72482456|NCT01794923|144492115|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.2||||0.528|TWO_SIDED|95.0|-0.77|0.4|||ANOVA|||9 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||0.40|-0.77|0.528
72511072|NCT05906732|144552559|SUPERIORITY||LS Mean|-9.6||||0.003|TWO_SIDED||||||Mixed Models Analysis|||||||0.0030
72511073|NCT05906732|144552560|SUPERIORITY||LS Mean|-6.5||||0.0266|TWO_SIDED||||||Mixed Models Analysis|||||||0.0266
72511074|NCT05906732|144552561|SUPERIORITY||LS Mean|-7.8||||0.0067|TWO_SIDED||||||Mixed Models Analysis|||||||0.0067
72511075|NCT05906732|144552562|SUPERIORITY||LS Mean|-3.9||||0.1106|TWO_SIDED||||||Mixed Models Analysis|||||||0.1106
72511076|NCT05906732|144552563|SUPERIORITY||LS Mean|-4.2||||0.0908|TWO_SIDED||||||Mixed Models Analysis|||||||0.0908
72511077|NCT05906732|144552564|SUPERIORITY||LS Mean|-1.2||||0.4038|TWO_SIDED||||||Mixed Models Analysis|||||||0.4038
72511078|NCT05906732|144552565|SUPERIORITY||LS Mean|1.5||||0.6255|TWO_SIDED||||||Mixed Models Analysis|||||||0.6255
72511079|NCT05906732|144552566|SUPERIORITY||LS Mean|0.2||||0.514|TWO_SIDED||||||Mixed Models Analysis|||||||0.5140
72511080|NCT05906732|144552567|SUPERIORITY||LS Mean|0.8||||0.5675|TWO_SIDED||||||Mixed Models Analysis|||||||0.5675
72511081|NCT05906732|144552568|SUPERIORITY||LS Mean|3.4||||0.764|TWO_SIDED||||||Mixed Models Analysis|||||||0.7640
72511082|NCT05906732|144552569|SUPERIORITY||LS Mean|-2.8||||0.2437|TWO_SIDED||||||Mixed Models Analysis|||||||.2437
72511083|NCT05906732|144552570|SUPERIORITY||LS Mean|-0.8||||0.4229|TWO_SIDED||||||Mixed Models Analysis|||||||0.4229
72511084|NCT05906732|144552571|SUPERIORITY||LS Mean|-0.1||||0.4887|TWO_SIDED||||||Mixed Models Analysis|||||||0.4887
72511085|NCT05906732|144552572|SUPERIORITY||LS Mean|-3.1||||0.2042|TWO_SIDED||||||Mixed Models Analysis|||||||0.2042
72511086|NCT05906732|144552573|SUPERIORITY||Mean Difference (Net)|-2.2||||0.2644|TWO_SIDED||||||Mixed Models Analysis|||||||0.2644
72402093|NCT02515942|144311356|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-0.38||||0.4444|TWO_SIDED|80.0|-3.89|3.13|||Mixed Models Analysis|||Change from baseline at Day 141||3.13|-3.89|0.4444
72511087|NCT05906732|144552591|SUPERIORITY||Mean Difference (Net)|4.28||||0.3169|TWO_SIDED||||||t-test, 2 sided|||||||0.3169
72511088|NCT05906732|144552592|SUPERIORITY||Mean Difference (Net)|6.78||||0.1066|TWO_SIDED||||||t-test, 2 sided|||||||0.1066
72511089|NCT05906732|144552593|SUPERIORITY||Mean Difference (Net)|-16.06||||0.0443|TWO_SIDED||||||t-test, 2 sided|||||||0.0443
72511090|NCT05906732|144552594|SUPERIORITY||Mean Difference (Net)|-9.06||||0.0815|TWO_SIDED||||||t-test, 2 sided|||||||0.0815
72511091|NCT05906732|144552595|SUPERIORITY||Mean Difference (Net)|-10.67||||0.0137|TWO_SIDED||||||t-test, 2 sided|||||||0.0137
72511092|NCT05906732|144552596|SUPERIORITY||Mean Difference (Net)|-4.0||||0.3539|TWO_SIDED||||||t-test, 2 sided|||||||0.3539
72511093|NCT05906732|144552597|SUPERIORITY||Mean Difference (Net)|9.78||||0.1377|TWO_SIDED||||||t-test, 2 sided|||||||0.1377
72511094|NCT05906732|144552598|SUPERIORITY||Mean Difference (Net)|-2.69||||0.6184|TWO_SIDED||||||t-test, 2 sided|||||||0.6184
72511095|NCT05906732|144552599|SUPERIORITY||Mean Difference (Net)|3.17||||0.6627|TWO_SIDED||||||t-test, 2 sided|||||||0.6627
72511096|NCT05906732|144552600|SUPERIORITY||Mean Difference (Net)|5.78||||0.5276|TWO_SIDED||||||t-test, 2 sided|||||||0.5276
72511097|NCT05906732|144552601|SUPERIORITY||Mean Difference (Net)|15.17||||0.0399|TWO_SIDED||||||t-test, 2 sided|||||||0.0399
72511098|NCT05906732|144552602|SUPERIORITY||Mean Difference (Net)|13.56||||0.0747|TWO_SIDED||||||t-test, 2 sided|||||||0.0747
72511099|NCT05906732|144552603|SUPERIORITY|||||||0.9584|||||||t-test, 2 sided|||||||0.9584
72511100|NCT05906732|144552604|SUPERIORITY||Mean Difference (Net)|5.72||||0.6531|TWO_SIDED||||||t-test, 2 sided|||||||0.6531
72511101|NCT05906732|144552605|SUPERIORITY||Mean Difference (Net)|15.61||||0.0482|TWO_SIDED||||||t-test, 2 sided|||||||0.0482
72511102|NCT05906732|144552606|SUPERIORITY||Mean Difference (Net)|17.22||||0.0667|TWO_SIDED||||||t-test, 2 sided|||||||0.0667
72511103|NCT05906732|144552607|SUPERIORITY||Mean Difference (Net)|-37.0||||0.0131|TWO_SIDED||||||t-test, 2 sided|||||||0.0131
72511104|NCT05906732|144552608|SUPERIORITY||Mean Difference (Net)|-32.36||||0.0141|TWO_SIDED||||||t-test, 2 sided|||||||0.0141
72511105|NCT05906732|144552609|SUPERIORITY||Mean Difference (Net)|-44.55||||0.0019|TWO_SIDED||||||t-test, 2 sided|||||||0.0019
72511106|NCT05906732|144552610|SUPERIORITY||Mean Difference (Net)|-31.69||||0.1108|TWO_SIDED||||||t-test, 2 sided|||||||0.1108
72511107|NCT05906732|144552611|SUPERIORITY||Mean Difference (Net)|37.81||||0.184|TWO_SIDED||||||t-test, 2 sided|||||||0.1840
72511108|NCT05906732|144552612|SUPERIORITY||Mean Difference (Net)|27.33||||0.2019|TWO_SIDED||||||t-test, 2 sided|||||||0.2019
72511109|NCT05906732|144552613|SUPERIORITY|||||||0.2808|||||||t-test, 2 sided|||||||0.2808
72511110|NCT05906732|144552614|SUPERIORITY||Mean Difference (Net)|110.39||||0.1644|TWO_SIDED||||||t-test, 2 sided|||||||0.1644
72511111|NCT05906732|144552615|SUPERIORITY||Mean Difference (Net)|-44.29||||0.0282|TWO_SIDED||||||t-test, 2 sided|||||||0.0282
72511112|NCT05906732|144552616|SUPERIORITY||Mean Difference (Net)|-37.87||||0.0306|TWO_SIDED||||||t-test, 2 sided|||||||0.0306
72511113|NCT05906732|144552617|SUPERIORITY||Mean Difference (Net)|-53.42||||0.0016|TWO_SIDED||||||t-test, 2 sided|||||||0.0016
72511114|NCT05906732|144552618|SUPERIORITY||Mean Difference (Net)|-44.25||||0.1378|TWO_SIDED||||||t-test, 2 sided|||||||0.1378
72511115|NCT03207022|144552626|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
72511116|NCT03207022|144552627|OTHER|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||||||0.001
72511117|NCT03207022|144552628|OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
72511118|NCT02336594|144552652|NON_INFERIORITY_OR_EQUIVALENCE|The sample size is not based on formal power calculations, as this study is designed only to provide an initial assessment of the Pharmacokinetics (PK), Pharmacodynamics (PD), and safety profile of RDEA3170.|Geometric Least Squares Mean Ratio (%)|107.0|||||TWO_SIDED|90.0|95.2|120.0|||Mixed Models Analysis|A mixed effect model on the natural log-transformed PK parameters Cmax, AUClast, and AUC∞ with fixed effect for treatment.||||120|95.2|
72511119|NCT02336594|144552654|NON_INFERIORITY_OR_EQUIVALENCE|The sample size is not based on formal power calculations, as this study is designed only to provide an initial assessment of the PK, PD, and safety profile of RDEA3170.|Geometric Least Squares mean Ratio (%)|97.3|||||TWO_SIDED|90.0|85.6|111.0|||Mixed Models Analysis|A mixed effect model on the natural log-transformed PK parameters Cmax, AUClast, and AUC∞ with fixed effect for treatment.||||111|85.6|
72402094|NCT02515942|144311356|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|3.47||||0.8977|TWO_SIDED|80.0|-0.04|6.97|||Mixed Models Analysis|||Change from baseline at Day 141||6.97|-0.04|0.8977
72402095|NCT02515942|144311356|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-0.05||||0.4917|TWO_SIDED|80.0|-2.92|2.82|||Mixed Models Analysis|||Change from baseline at Day 169||2.82|-2.92|0.4917
72511120|NCT02336594|144552655|NON_INFERIORITY_OR_EQUIVALENCE|The sample size is not based on formal power calculations, as this study is designed only to provide an initial assessment of the PK, PD, and safety profile of RDEA3170.|Geometric Least Squares mean Ratio (%)|100.0|||||TWO_SIDED|90.0|87.3|115.0|||Mixed Models Analysis|A mixed effect model on the natural log-transformed PK parameters Cmax, AUClast, and AUC∞ with fixed effect for treatment.||||115|87.3|
72566965|NCT02508259|144664588|EQUIVALENCE|In this analysis, the child-specific RBQ score was tested for equivalence before and 6-weeks after suramin treatment.|Mean Difference (Net)|-3.2|STANDARD_DEVIATION|5.8||0.28|TWO_SIDED|95.0|-10.4|4.0|||t-test, 2 sided|||In this analysis, each child was used as their own control to examine before and after suramin treatment effects in a paired t-test design. This study was a small pilot study of safety and activity of suramin. The small subject numbers of just 5 per group make it impossible to draw any strong conclusions about efficacy. Future studies are required.||4.0|-10.4|0.28
72482457|NCT01794923|144492115|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.4||||0.229|TWO_SIDED|95.0|-0.24|1.01|||ANOVA|||9 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||1.01|-0.24|0.229
72482458|NCT01794923|144492115|SUPERIORITY_OR_OTHER_LEGACY|||||||0.536|TWO_SIDED||||||ANOVA|||10 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||||0.536
72482459|NCT01794923|144492115|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.1||||0.728|TWO_SIDED|95.0|-0.49|0.7|||ANOVA|||10 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||0.70|-0.49|0.728
72482460|NCT01794923|144492115|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.2||||0.414|TWO_SIDED|95.0|-0.84|0.35|||ANOVA|||10 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||0.35|-0.84|0.414
72482461|NCT01794923|144492115|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.4||||0.28|TWO_SIDED|95.0|-0.29|0.99|||ANOVA|||10 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||0.99|-0.29|0.280
72482462|NCT01794923|144492115|SUPERIORITY_OR_OTHER_LEGACY|||||||0.402|TWO_SIDED||||||ANOVA|||11 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||||0.402
72482463|NCT01794923|144492115|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.2||||0.513|TWO_SIDED|95.0|-0.41|0.81|||ANOVA|||11 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||0.81|-0.41|0.513
72482464|NCT01794923|144492115|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.2||||0.424|TWO_SIDED|95.0|-0.86|0.36|||ANOVA|||11 hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||0.36|-0.86|0.424
72482465|NCT01794923|144492115|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.4||||0.178|TWO_SIDED|95.0|-0.21|1.1|||ANOVA|||11 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||1.10|-0.21|0.178
72482466|NCT01794923|144492115|SUPERIORITY_OR_OTHER_LEGACY|||||||0.442|TWO_SIDED||||||ANOVA|||12 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||||0.442
72482467|NCT01794923|144492115|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.3||||0.357|TWO_SIDED|95.0|-0.33|0.91|||ANOVA|||12 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||0.91|-0.33|0.357
72482468|NCT01794923|144492115|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.1||||0.675|TWO_SIDED|95.0|-0.75|0.49|||ANOVA|||12 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||0.49|-0.75|0.675
72482469|NCT01794923|144492115|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.4||||0.215|TWO_SIDED|95.0|-0.25|1.09|||ANOVA|||12 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||1.09|-0.25|0.215
72482470|NCT01794923|144492115|SUPERIORITY_OR_OTHER_LEGACY|||||||0.643|TWO_SIDED||||||ANOVA|||24 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||||0.643
72482471|NCT01794923|144492115|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.3||||0.466|TWO_SIDED|95.0|-0.46|0.99|||ANOVA|||24 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||0.99|-0.46|0.466
72402096|NCT02515942|144311356|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-0.05||||0.4909|TWO_SIDED|80.0|-2.89|2.79|||Mixed Models Analysis|||Change from baseline at Day 169||2.79|-2.89|0.4909
72402097|NCT02515942|144311356|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|0.0||||0.4992|TWO_SIDED|80.0|-2.82|2.81|||Mixed Models Analysis|||Change from baseline at Day 169||2.81|-2.82|0.4992
72566966|NCT00518622|144664590|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.01||||||95.0|-2.87|-1.14|||||Mean (Day 8 - baseline) HCV RNA for MK7009 25 mg bid minus mean (Day 8 - baseline) HCV RNA for placebo|||-1.14|-2.87|
72566967|NCT00518622|144664590|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.64||||||95.0|-3.49|-1.8|||||Mean (Day 8 - baseline) HCV RNA for MK7009 75 mg bid minus mean (Day 8 - baseline) HCV RNA for placebo|||-1.80|-3.49|
72566968|NCT00518622|144664590|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.9||||||95.0|-3.9|-1.9|||||Mean (Day 8 - baseline) HCV RNA for MK7009 250 mg bid minus mean (Day 8 - baseline) HCV RNA for placebo|||-1.90|-3.90|
72566969|NCT00518622|144664590|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.38||||||95.0|-4.59|-2.17|||||Mean (Day 8 - baseline) HCV RNA for MK7009 500 mg bid minus mean (Day 8 - baseline) HCV RNA for placebo|||-2.17|-4.59|
72566970|NCT00518622|144664590|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.73||||||95.0|-5.15|-4.31|||||Mean (Day 8 - baseline) HCV RNA for MK7009 700 mg bid minus mean (Day 8 - baseline) HCV RNA for placebo|||-4.31|-5.15|
72566971|NCT00518622|144664590|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.93||||||95.0|-2.68|-1.18|||||Mean (Day 8 - baseline) HCV RNA for MK7009 125 mg qd minus mean (Day 8 - baseline) HCV RNA for placebo|||-1.18|-2.68|
72566972|NCT00518622|144664590|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.46||||||95.0|-2.78|-2.13|||||Mean (Day 8 - baseline) HCV RNA for MK7009 600 mg qd minus mean (Day 8 - baseline) HCV RNA for placebo|||-2.13|-2.78|
72566973|NCT02054130|144664653|SUPERIORITY||Rate ratio|0.38|||<|0.001|TWO_SIDED|95.0|0.23|0.63|||Negative binomial regression|||||0.63|0.23|<0.001
72566974|NCT02054130|144664653|SUPERIORITY||Rate ratio|0.29|||<|0.001|TWO_SIDED|95.0|0.16|0.51|||Negative binomial regression|||||0.51|0.16|<0.001
72566975|NCT02054130|144664653|SUPERIORITY||Rate ratio|0.34|||<|0.001|TWO_SIDED|95.0|0.2|0.58|||Negative bnomial regression|||||0.58|0.20|<0.001
72566976|NCT00094458|144664675|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|The P-Value is from a CMH test stratified by duration of Crohn's disease and corticosteroid treatment at Baseline||||||<0.001
72566977|NCT00094458|144664675|SUPERIORITY_OR_OTHER|||||||0.006|||||||Cochran-Mantel-Haenszel|The P-Value is from a CMH test stratified by duration of Crohn's disease and corticosteroid treatment at Baseline||||||0.006
72566978|NCT00094458|144664675|SUPERIORITY_OR_OTHER|||||||0.022|||||||Cochran-Mantel-Haenszel|The P-Value is from a CMH test stratified by duration of Crohn's disease and corticosteroid treatment at Baseline||||||0.022
72482472|NCT01794923|144492115|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.1||||0.818|TWO_SIDED|95.0|-0.81|0.64|||ANOVA|||24 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||0.64|-0.81|0.818
72482473|NCT01794923|144492115|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.4||||0.373|TWO_SIDED|95.0|-0.43|1.13|||ANOVA|||24 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||1.13|-0.43|0.373
72482474|NCT01794923|144492115|SUPERIORITY_OR_OTHER_LEGACY|||||||0.984|TWO_SIDED||||||ANOVA|||30 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||||0.984
72482475|NCT01794923|144492115|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.1||||0.874|TWO_SIDED|95.0|-0.79|0.68|||ANOVA|||30 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||0.68|-0.79|0.874
72566979|NCT00094458|144664676|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel|The P-Value is from a CMH test stratified by duration of Crohn's disease and corticosteroid treatment at Baseline||||||<0.001
72482476|NCT01794923|144492115|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.0||||0.99|TWO_SIDED|95.0|-0.73|0.74|||ANOVA|||30 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||0.74|-0.73|0.990
72482477|NCT01794923|144492115|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.1||||0.875|TWO_SIDED|95.0|-0.85|0.73|||ANOVA|||30 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||0.73|-0.85|0.875
72482478|NCT01794923|144492115|SUPERIORITY_OR_OTHER_LEGACY|||||||0.841|TWO_SIDED||||||ANOVA|||36 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||||0.841
72482479|NCT01794923|144492115|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.2||||0.58|TWO_SIDED|95.0|-1.01|0.57|||ANOVA|||36 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||0.57|-1.01|0.580
72482480|NCT01794923|144492115|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.0||||0.958|TWO_SIDED|95.0|-0.81|0.77|||ANOVA|||36 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||0.77|-0.81|0.958
72566980|NCT00094458|144664676|SUPERIORITY_OR_OTHER|||||||0.023||95.0|||||Cochran-Mantel-Haenszel|The P-Value is from a CMH test stratified by duration of Crohn's disease and corticosteroid treatment at Baseline||||||0.023
72566981|NCT00094458|144664676|SUPERIORITY_OR_OTHER|||||||0.055||95.0|||||Cochran-Mantel-Haenszel|The P-Value is from a CMH test stratified by duration of Crohn's disease and corticosteroid treatment at Baseline||||||0.055
72566982|NCT02011113|144664685|SUPERIORITY_OR_OTHER|||||||0.0027||||||Based on one sample binomial test for dichotomized response proportion against the null hypothesis(H0: p = 0.1)|Binomial test for dichotomized response|||||||0.0027
72566983|NCT02274844|144664696|SUPERIORITY|The outcomes were all continuous or ordinal measures, thus unadjusted hypothesis tests used t-tests or the Wilcoxon-Mann-Whitney test, as appropriate, and statistical modeling used linear regression. ANCOVA was used to adjust for baseline covariates with imbalance across treatment arms (race) and baseline values of the measures.|Mean Difference (Final Values)|-0.09||||0.22|TWO_SIDED|95.0|-0.23|0.05||The main hypotheses tested were that intervention participants would have higher medication adherence and significantly greater improvement in A1c, BP, LDL-C, and measures of quality of life, and self-efficacy compared to control participants.|ANCOVA|||The study was powered to detect clinically meaningful differences in physiologic risk factors; it had four primary outcomes.Power estimates accounted for clustering of patients within towns, using a variance inflation factor, conservatively estimating power for ICC=0.01-0.05. Process measures were selected to understand which aspects of the intervention were particularly effective, assessing both program satisfaction and peer coach effectiveness.||0.05|-0.23|0.22
72566984|NCT00468728|144664715|NON_INFERIORITY_OR_EQUIVALENCE|The point estimate of the difference and the 2-sided 95% confidence interval (CI) for the difference between treatment groups were computed. If the lower limit of the CI was greater than -10%, the clinical non-inferiority of fidaxomicin was demonstrated. CIs for the difference of cure rates were calculated using the method recommended by Agresti and Caffo.|Risk Difference (RD)|1.0|||||TWO_SIDED|95.0|-4.8|6.8||||||H0: C(OPT-80) - C(VAN) \<= -10% Power calculation is based on cure rate of 85% in both treatment groups, non-inferiority margin of 10%, 2.5% (1-sided) type I error rate with approximately 90% power gives a total of 530 subjects.||6.8|-4.8|
72566985|NCT00468728|144664716|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-14.4|||<|0.001|TWO_SIDED|95.0|-21.6|-7.0|||Chi-squared|||||-7.0|-21.6|<0.001
72566986|NCT00468728|144664717|SUPERIORITY_OR_OTHER||Risk Difference (RD)|13.4||||0.001||95.0|5.4|21.1|||Chi-squared|||||21.1|5.4|0.001
72566987|NCT02712333|144664725|SUPERIORITY_OR_OTHER||% increase per 10μg/m3 increase of PM2.5|7.53|||<|0.05|TWO_SIDED|95.0|4.65|10.41||the p-value has been adjusted for multiple comparisons|Mixed Models Analysis|||we analyzed the serum cortisol levels (presented as relative intensities in high perfomance liquid chromatography-mass spectrum) by treatments (intervention group vs control group)||10.41|4.65|<0.05
72566988|NCT02712333|144664725|SUPERIORITY_OR_OTHER||fold change|1.33|||<|0.01|TWO_SIDED||||||t-test, 2 sided||fold change is calculated by measurments from the sham purification group/measurements from the real purification group|||||<0.01
72566989|NCT02712333|144664726|SUPERIORITY_OR_OTHER||% increase per 10μg/m3 increase of PM2.5|3.69|||<|0.01|TWO_SIDED|95.0|1.85|5.54||the p-value has been adjusted for multiple comparisons.|Mixed Models Analysis|||we analyzed the serum cortisone levels by treatment (intervention group vs control group)||5.54|1.85|<0.01
72566990|NCT02712333|144664726|SUPERIORITY_OR_OTHER||fold change|1.18|||<|0.01|TWO_SIDED||||||t-test, 2 sided||fold change is calculated by measurments from the sham purification group/measurements from the real purification group|||||<0.01
72566991|NCT02712333|144664727|SUPERIORITY_OR_OTHER||% increase per 10μg/m3 increase of PM2.5|5.17|||<|0.01|TWO_SIDED|95.0|3.21|7.14||the p-value has been adjusted for multiple comparisons.|Mixed Models Analysis|||we analyzed the serum epinephrine levels by treatment (intervention group vs control group)||7.14|3.21|<0.01
72566992|NCT02712333|144664727|SUPERIORITY_OR_OTHER||fold change|1.2|||<|0.01|TWO_SIDED||||||t-test, 2 sided||fold change is calculated by measurments from the sham purification group/measurements from the real purification group|||||<0.01
72566993|NCT02712333|144664728|SUPERIORITY_OR_OTHER||% increase per 10μg/m3 increase of PM2.5|11.28|||<|0.01|TWO_SIDED|95.0|7.37|15.21||the p-value has been adjusted for multiple comparisons|Mixed Models Analysis|||we analyzed the serum norepinephrine levels by treatment (intervention group vs control group)||15.21|7.37|<0.01
72566994|NCT02712333|144664728|SUPERIORITY_OR_OTHER||fold change|1.57|||<|0.01|TWO_SIDED||||||t-test, 2 sided||fold change is calculated by measurments from the sham purification group/measurements from the real purification group|||||<0.01
72566995|NCT02712333|144664729|SUPERIORITY_OR_OTHER||% increase per 10μg/m3 increase of PM2.5|0.84|||<|0.01|TWO_SIDED|95.0|0.09|1.59|||Mixed Models Analysis|||we analyzed the serum SBP levels by treatment (intervention group vs control group)||1.59|0.09|<0.01
72566996|NCT02712333|144664730|SUPERIORITY_OR_OTHER||% increase per 10μg/m3 increase of PM2.5|0.31|||>|0.05|TWO_SIDED|95.0|-1.59|0.96|||Mixed Models Analysis|||we analyzed the serum cortisol levels by treatment (intervention group vs control group)||0.96|-1.59|>0.05
72566997|NCT02712333|144664731|SUPERIORITY_OR_OTHER||% increase per 10μg/m3 increase of PM2.5|1.24|||>|0.05|TWO_SIDED|95.0|-1.14|3.63|||Mixed Models Analysis|||we analyzed the serum cortisol levels by treatment (intervention group vs control group)||3.63|-1.14|>0.05
72566998|NCT03463993|144664732|SUPERIORITY|||||||0.549||||||The p-value above is the calculated P value based on hematocrit.|Chi-squared|||The null hypothesis was that intravenous Tranexamic Acid (TXA) 10mg/kg plus Oxytocin 5IU does not result in a lower incidence of primary postpartum haemorrhage compared to Oxytocin alone after elective caesarean section||||0.549
72566999|NCT03463993|144664732|SUPERIORITY|||||||0.138||||||This is the calculated p-value based on hemoglobin .|Chi-squared|||The null hypothesis was that intravenous Tranexamic Acid (TXA)10mg/kg plus Oxytocin 5IU does not result in a lower incidence of primary postpartum haemorrhage compared to Oxytocin alone after elective caesarean section||||0.138
72567000|NCT03463993|144664733|SUPERIORITY|||||||0.789||||||0.789 is the calculated p-value for visually estimated blood loss: Visually estimated blood loss (ml): Group A mean 483.73 (standard deviation182.56); Group B 479.61 (139.49); p-value 0.789|t-test, 2 sided|||||||0.789
72567001|NCT03463993|144664733|SUPERIORITY|||||||0.968||||||0.968 is the calculated p-value based on hematocrit. Hematocrit-based calculation of estimated blood loss(ml): Group A mean 650.06 (standard deviation 631.50); Group B 653.05 (796.03); p-value 0.968|t-test, 2 sided|||||||0.968
72567002|NCT03463993|144664733|SUPERIORITY|||||||0.447||||||Hemoglobin-based calculation of estimated blood loss(ml) mean(standard deviation): Group A 644.30 (692.27); Group B 707.68 (948.01); p-value 0.447|t-test, 2 sided|||||||0.447
72402098|NCT02515942|144311356|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-1.09||||0.3285|TWO_SIDED|80.0|-4.25|2.07|||Mixed Models Analysis|||Change from baseline at Day 197||2.07|-4.25|0.3285
72402099|NCT02515942|144311356|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-2.45||||0.1568|TWO_SIDED|80.0|-5.57|0.67|||Mixed Models Analysis|||Change from baseline at Day 197||0.67|-5.57|0.1568
72402100|NCT02515942|144311356|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-1.36||||0.2867|TWO_SIDED|80.0|-4.46|1.74|||Mixed Models Analysis|||Change from baseline at Day 197||1.74|-4.46|0.2867
72402101|NCT02515942|144311356|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-3.93||||0.0798|TWO_SIDED|80.0|-7.51|-0.35|||Mixed Models Analysis|||Change from baseline at Day 225||-0.35|-7.51|0.0798
72511121|NCT02336594|144552657|NON_INFERIORITY_OR_EQUIVALENCE|The sample size is not based on formal power calculations, as this study is designed only to provide an initial assessment of the PK, PD, and safety profile of RDEA3170.|Geometric Least Squares mean Ratio (%)|182.0|||||TWO_SIDED|90.0|144.0|230.0|||Mixed Models Analysis|A mixed effect model on the natural log-transformed PK parameters Cmax, AUClast, and AUC∞ with fixed effect for treatment.||||230|144|
72402102|NCT02515942|144311356|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-1.47||||0.2962|TWO_SIDED|80.0|-5.0|2.06|||Mixed Models Analysis|||Change from baseline at Day 225||2.06|-5.00|0.2962
72402103|NCT02515942|144311356|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|2.46||||0.8163|TWO_SIDED|80.0|-1.05|5.98|||Mixed Models Analysis|||Change from baseline at Day 225||5.98|-1.05|0.8163
72402104|NCT02515942|144311356|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-3.64||||0.0708|TWO_SIDED|80.0|-6.81|-0.47|||Mixed Models Analysis|||Change from baseline at Day 253||-0.47|-6.81|0.0708
72402105|NCT02515942|144311356|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|0.46||||0.575|TWO_SIDED|80.0|-2.67|3.59|||Mixed Models Analysis|||Change from baseline at Day 253||3.59|-2.67|0.5750
72402106|NCT02515942|144311356|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|4.1||||0.956|TWO_SIDED|80.0|1.03|7.17|||Mixed Models Analysis|||Change from baseline at Day 253||7.17|1.03|0.9560
72511122|NCT02336594|144552658|NON_INFERIORITY_OR_EQUIVALENCE|The sample size is not based on formal power calculations, as this study is designed only to provide an initial assessment of the PK, PD, and safety profile of RDEA3170.|Geometric Least Squares mean Ratio (%)|140.0|||||TWO_SIDED|90.0|121.0|163.0|||Mixed Models Analysis|A mixed effect model on the natural log-transformed PK parameters Cmax, AUClast, and AUC∞ with fixed effect for treatment.||||163|121|
72511123|NCT02336594|144552659|NON_INFERIORITY_OR_EQUIVALENCE|The sample size is not based on formal power calculations, as this study is designed only to provide an initial assessment of the PK, PD, and safety profile of RDEA3170.|Geometric Least Squares mean Ratio (%)|134.0|||||TWO_SIDED|90.0|114.0|156.0|||Mixed Models Analysis|A mixed effect model on the natural log-transformed PK parameters Cmax, AUClast, and AUC∞ with fixed effect for treatment.||||156|114|
72511124|NCT02336594|144552660|NON_INFERIORITY_OR_EQUIVALENCE|The sample size is not based on formal power calculations, as this study is designed only to provide an initial assessment of the PK, PD, and safety profile of RDEA3170.|Geometric Least Squares mean Ratio (%)|79.1|||||TWO_SIDED|90.0|66.4|94.2|||Mixed Models Analysis|A mixed effect model on the natural log-transformed PK parameters Cmax, AUClast, and AUC∞ with fixed effect for treatment.||||94.2|66.4|
72567003|NCT03463993|144664734|SUPERIORITY||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
72567004|NCT03463993|144664735|SUPERIORITY||||||<|0.05|||||||Chi-squared|||||||<0.05
72567005|NCT01553747|144664758|SUPERIORITY||||||<|0.001||||||Significance level of 0.025|Chi-square test statistic|||The family-wise error rate was controlled by Bonferroni adjustment for each active dose versus placebo.||||<0.001
72567006|NCT01553747|144664758|SUPERIORITY||||||<|0.001||||||Significance level of 0.025|Chi-square test statistic|||The family-wise error rate was controlled by Bonferroni adjustment for each active dose versus placebo.||||<0.001
72567007|NCT01553747|144664759|SUPERIORITY|||||||0.001||||||Significance level of 0.025|Chi-square test statistic|||The family-wise error rate was controlled by Bonferroni adjustment for each active dose versus placebo.||||0.001
72402107|NCT02515942|144311356|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-3.22||||0.1283|TWO_SIDED|80.0|-6.86|0.42|||Mixed Models Analysis|||Change from baseline at Day 281||0.42|-6.86|0.1283
72402108|NCT02515942|144311356|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-2.28||||0.2085|TWO_SIDED|80.0|-5.88|1.33|||Mixed Models Analysis|||Change from baseline at Day 281||1.33|-5.88|0.2085
72482481|NCT01794923|144492115|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.2||||0.643|TWO_SIDED|95.0|-1.05|0.65|||ANOVA|||36 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||0.65|-1.05|0.643
72482482|NCT01794923|144492115|SUPERIORITY_OR_OTHER_LEGACY|||||||0.299|TWO_SIDED||||||ANOVA|||48 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||||0.299
72482483|NCT01794923|144492115|SUPERIORITY_OR_OTHER_LEGACY||LS mean Difference|-0.5||||0.23|TWO_SIDED|95.0|-1.26|0.31|||ANOVA|||48 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||0.31|-1.26|0.230
72482484|NCT01794923|144492115|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.2||||0.694|TWO_SIDED|95.0|-0.63|0.94|||ANOVA|||48 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||0.94|-0.63|0.694
72482485|NCT01794923|144492115|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.6||||0.14|TWO_SIDED|95.0|-1.48|0.21|||ANOVA|||48 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||0.21|-1.48|0.140
72482486|NCT01794923|144492115|SUPERIORITY_OR_OTHER_LEGACY|||||||0.503|TWO_SIDED||||||ANOVA|||54 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||||0.503
72511125|NCT02336594|144552661|NON_INFERIORITY_OR_EQUIVALENCE|The sample size is not based on formal power calculations, as this study is designed only to provide an initial assessment of the PK, PD, and safety profile of RDEA3170.|Geometric Least Squares mean Ratio (%)|85.5|||||TWO_SIDED|90.0|73.9|98.8|||Mixed Models Analysis|A mixed effect model on the natural log-transformed PK parameters Cmax, AUClast, and AUC∞ with fixed effect for treatment.||||98.8|73.9|
72482487|NCT01794923|144492115|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.5||||0.262|TWO_SIDED|95.0|-1.28|0.35|||ANOVA|||54 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||0.35|-1.28|0.262
72482488|NCT01794923|144492115|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.1||||0.871|TWO_SIDED|95.0|-0.88|0.75|||ANOVA|||54 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||0.75|-0.88|0.871
72482489|NCT01794923|144492115|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.4||||0.373|TWO_SIDED|95.0|-1.27|0.48|||ANOVA|||54 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||0.48|-1.27|0.373
72482490|NCT01794923|144492115|SUPERIORITY_OR_OTHER_LEGACY|||||||0.413|TWO_SIDED||||||ANOVA|||60 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||||0.413
72511126|NCT02336594|144552662|NON_INFERIORITY_OR_EQUIVALENCE|The sample size is not based on formal power calculations, as this study is designed only to provide an initial assessment of the PK, PD, and safety profile of RDEA3170.|Geometric Least Squares mean Ratio (%)|83.4|||||TWO_SIDED|90.0|73.5|94.7|||Mixed Models Analysis|A mixed effect model on the natural log-transformed PK parameters Cmax, AUClast, and AUC∞ with fixed effect for treatment.||||94.7|73.5|
72511127|NCT01212172|144552674|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.9||||0.2879|TWO_SIDED|95.0|-6.7|21.1|||t-test, 1 sided|||||21.1|-6.7|0.2879
72511128|NCT00904826|144552696|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon (Mann-Whitney)|||Comparison between before treatment and one year after treatment.||||<0.0001
72402109|NCT02515942|144311356|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|0.94||||0.6335|TWO_SIDED|80.0|-2.61|4.49|||Mixed Models Analysis|||Change from baseline at Day 281||4.49|-2.61|0.6335
72482491|NCT01794923|144492115|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.4||||0.317|TWO_SIDED|95.0|-1.22|0.4|||ANOVA|||60 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||0.40|-1.22|0.317
72482492|NCT01794923|144492115|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.2||||0.708|TWO_SIDED|95.0|-0.66|0.97|||ANOVA|||60 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||0.97|-0.66|0.708
72482493|NCT01794923|144492115|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.6||||0.202|TWO_SIDED|95.0|-1.44|0.31|||ANOVA|||60 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||0.31|-1.44|0.202
72482494|NCT01794923|144492115|SUPERIORITY_OR_OTHER_LEGACY|||||||0.19|TWO_SIDED||||||ANOVA|||72 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||||0.190
72482495|NCT01794923|144492115|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.7||||0.094|TWO_SIDED|95.0|-1.44|0.11|||ANOVA|||72 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||0.11|-1.44|0.094
72511129|NCT00904826|144552698|SUPERIORITY_OR_OTHER|||||||0.0078||95.0|||||Wilcoxon (Mann-Whitney)|||Comparison was made between baseline and after 12 months of treatment.||||0.0078
72511130|NCT00904826|144552702|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon (Mann-Whitney)|||Comparison is between 6 weeks and baseline.||||<0.0001
72511131|NCT00904826|144552702|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon (Mann-Whitney)|||Comparison is between 3 months and baseline.||||<0.0001
72511132|NCT00904826|144552702|SUPERIORITY_OR_OTHER|||||||0.0001||95.0|||||Wilcoxon (Mann-Whitney)|||Comparison is between 6 months and baseline||||0.0001
72511133|NCT00904826|144552702|SUPERIORITY_OR_OTHER|||||||0.0001||95.0|||||Wilcoxon (Mann-Whitney)|||Comparison is between 9 months and baseline.||||0.0001
72482496|NCT01794923|144492115|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.0||||0.96|TWO_SIDED|95.0|-0.8|0.76|||ANOVA|||72 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||0.76|-0.80|0.960
72482497|NCT01794923|144492115|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.6||||0.132|TWO_SIDED|95.0|-1.48|0.2|||ANOVA|||72 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||0.20|-1.48|0.132
72482498|NCT01794923|144492116|SUPERIORITY_OR_OTHER_LEGACY|||||||0.163|TWO_SIDED||||||ANOVA|||0-24 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||||0.163
72482499|NCT01794923|144492116|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|4.6||||0.162|TWO_SIDED|95.0|-1.86|11.02|||ANOVA|||0-24 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||11.02|-1.86|0.162
72482500|NCT01794923|144492116|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.9||||0.559|TWO_SIDED|95.0|-8.42|4.57|||ANOVA|||0-24 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||4.57|-8.42|0.559
72482501|NCT01794923|144492116|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|6.5||||0.066|TWO_SIDED|95.0|-0.44|13.45|||ANOVA|||0-24 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||13.45|-0.44|0.066
72511134|NCT00904826|144552702|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon (Mann-Whitney)|||Comparison is between 12 months and baseline.||||<0.0001
72402110|NCT02515942|144311356|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-2.64||||0.1778|TWO_SIDED|80.0|-6.31|1.03|||Mixed Models Analysis|||Change from baseline at Day 309||1.03|-6.31|0.1778
72482502|NCT01794923|144492116|SUPERIORITY_OR_OTHER_LEGACY|||||||0.957|TWO_SIDED||||||ANOVA|||24-48 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||||0.957
72482503|NCT01794923|144492116|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|1.1||||0.864|TWO_SIDED|95.0|-11.2|13.33|||ANOVA|||24-48 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||13.33|-11.20|0.864
72482504|NCT01794923|144492116|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.9||||0.883|TWO_SIDED|95.0|-13.3|11.45|||ANOVA|||24-48 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||11.45|-13.30|0.883
72482505|NCT01794923|144492116|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|2.0||||0.767|TWO_SIDED|95.0|-11.24|15.22|||ANOVA|||24-48 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||15.22|-11.24|0.767
72482506|NCT01794923|144492116|SUPERIORITY_OR_OTHER_LEGACY|||||||0.243|TWO_SIDED||||||ANOVA|||48-72 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||||0.243
72482507|NCT01794923|144492116|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-8.2||||0.176|TWO_SIDED|95.0|-20.12|3.7|||ANOVA|||48-72 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||3.70|-20.12|0.176
72482508|NCT01794923|144492116|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|2.0||||0.741|TWO_SIDED|95.0|-10.0|14.03|||ANOVA|||48-72 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||14.03|-10.00|0.741
72482509|NCT01794923|144492116|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-10.2||||0.118|TWO_SIDED|95.0|-23.07|2.62|||ANOVA|||48-72 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||2.62|-23.07|0.118
72511135|NCT00904826|144552704|SUPERIORITY_OR_OTHER|||||||0.0019||95.0|||||Wilcoxon (Mann-Whitney)|||Comparison was between 3 months and baseline.||||0.0019
72482510|NCT01794923|144492116|SUPERIORITY_OR_OTHER_LEGACY|||||||0.92|TWO_SIDED||||||ANOVA|||0-72 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||||0.920
72482511|NCT01794923|144492116|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-4.2||||0.685|TWO_SIDED|95.0|-24.64|16.23|||ANOVA|||0-72 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||16.23|-24.64|0.685
72482512|NCT01794923|144492116|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.4||||0.892|TWO_SIDED|95.0|-22.04|19.19|||ANOVA|||0-72 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||19.19|-22.04|0.892
72482513|NCT01794923|144492116|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-2.8||||0.804|TWO_SIDED|95.0|-24.82|19.25|||ANOVA|||0-72 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||19.25|-24.82|0.804
72482514|NCT01794923|144492117|SUPERIORITY_OR_OTHER_LEGACY|||||||0.533|TWO_SIDED||||||ANOVA|||Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMSM terms.||||0.533
72482515|NCT01794923|144492117|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.5||||0.266|TWO_SIDED|95.0|-0.38|1.38|||ANOVA|||Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMSM terms.||1.38|-0.38|0.266
72511136|NCT01798706|144552752|SUPERIORITY_OR_OTHER||Least Square (LS) Mean Difference|-0.64|STANDARD_ERROR_OF_MEAN|0.088|<|0.0001|TWO_SIDED|95.0|-0.81|-0.464||Threshold for significance at 0.05 level.|ANCOVA||Lixisenatide vs Placebo|Analysis was performed using analysis of covariance (ANCOVA) model with treatment groups, randomization strata of Week -1 HbA1c (\<8.0, ≥8.0%), randomization strata of basal insulin use at screening, randomization strata of Week -1 glomerular filtration rate (eGFR) (≥30 to \<60, ≥60 ml/min/1.73 m\^2), and country as fixed effects and baseline HbA1c value as a covariate.||-0.464|-0.81|< 0.0001
72567008|NCT01553747|144664759|SUPERIORITY||||||<|0.001||||||Significance level of 0.025|Chi-square test statistic|||The family-wise error rate was controlled by Bonferroni adjustment for each active dose versus placebo.||||<0.001
72402111|NCT02515942|144311356|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-0.7||||0.4027|TWO_SIDED|80.0|-4.33|2.94|||Mixed Models Analysis|||Change from baseline at Day 309||2.94|-4.33|0.4027
72402112|NCT02515942|144311356|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|1.94||||0.757|TWO_SIDED|80.0|-1.64|5.53|||Mixed Models Analysis|||Change from baseline at Day 309||5.53|-1.64|0.7570
72402113|NCT02515942|144311356|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-3.9||||0.1132|TWO_SIDED|80.0|-8.03|0.23|||Mixed Models Analysis|||Change from baseline at Day 337||0.23|-8.03|0.1132
72402114|NCT02515942|144311356|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-2.71||||0.1965|TWO_SIDED|80.0|-6.8|1.37|||Mixed Models Analysis|||Change from baseline at Day 337||1.37|-6.80|0.1965
72402115|NCT02515942|144311356|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|1.18||||0.6471|TWO_SIDED|80.0|-2.85|5.21|||Mixed Models Analysis|||Change from baseline at Day 337||5.21|-2.85|0.6471
72402116|NCT00666757|144311365|SUPERIORITY_OR_OTHER|||||||0.26||95.0|||||Mixed Models Analysis|||Categorical, pseudo-likelihood-based repeated measures approach (MMRM-CAT). The analysis will contrast the remission rates at 12 week endpoint between treatment groups.||||0.26
72402117|NCT00666757|144311366|SUPERIORITY_OR_OTHER|||||||0.07||95.0|||||Mixed Models Analysis|||Repeated Measures Analysis.Treatment comparisons will include the contrast between treatment groups at 12-week endpoint.||||0.07
72402118|NCT00666757|144311367|SUPERIORITY_OR_OTHER|||||||0.03||95.0|||||Mixed Models Analysis|||Categorical, pseudo-likelihood-based repeated measures approach (MMRM-CAT). Repeated Measures Analysis. The analysis will contrast the remission remission rates at 12-week endpoint.||||0.03
72402119|NCT00666757|144311368|SUPERIORITY_OR_OTHER|||||||0.09||95.0|||||Mixed Models Analysis|||Categorical, pseudo-likelihood-based repeated measures approach (MMRM-CAT). The analysis will contrast the response rates at 12-week endpoint.||||0.09
72402120|NCT00666757|144311369|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||Mixed Models Analysis|||Categorical, pseudo-likelihood-based repeated measures approach (MMRM-CAT). The analysis will contrast the response rates at 12-week endpoint.||||0.001
72402121|NCT00666757|144311370|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||Mixed Models Analysis|||Repeated Measures Analysis. Treatment comparisons will include the contrast between treatment groups at 12-Week endpoint.||||0.002
72402122|NCT00666757|144311371|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||Mixed Models Analysis|||Repeated Measures Analysis. Treatment comparisons will include the contrast between treatment groups at 12-Week endpoint.||||0.001
72402123|NCT00666757|144311372|SUPERIORITY_OR_OTHER|||||||0.003||95.0|||||Mixed Models Analysis|||Repeated Measures Analysis. Treatment comparisons will include the contrast between treatment groups at 12-Week endpoint.||||0.003
72402124|NCT00666757|144311373|SUPERIORITY_OR_OTHER|||||||0.01||95.0|||||Mixed Models Analysis|||Repeated Measures Analysis.Treatment comparisons will include the contrast between treatment groups at 12-Week endpoint.||||0.01
72402125|NCT00666757|144311374|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||Mixed Models Analysis|||Repeated Measures Analysis. Treatment comparisons will include the contrast between treatment groups at 12-Week endpoint.||||0.02
72402126|NCT00666757|144311375|SUPERIORITY_OR_OTHER|||||||0.2||95.0|||||Mixed Models Analysis|||Repeated Measures Analysis. Treatment comparisons will include the contrast between treatment groups at 12-Week endpoint.||||0.20
72482516|NCT01794923|144492117|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.2||||0.73|TWO_SIDED|95.0|-0.74|1.05|||ANOVA|||Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMSM terms.||1.05|-0.74|0.730
72482517|NCT01794923|144492117|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.3||||0.479|TWO_SIDED|95.0|-0.61|1.3|||ANOVA|||Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMSM terms.||1.30|-0.61|0.479
72482518|NCT01794923|144492118|SUPERIORITY_OR_OTHER_LEGACY|||||||0.189|TWO_SIDED||||||ANOVA|||1 Hour: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||||0.189
72482519|NCT01794923|144492118|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.1||||0.389|TWO_SIDED|95.0|-0.17|0.07|||ANOVA|||1 Hour: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.07|-0.17|0.389
72482520|NCT01794923|144492118|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.1||||0.273|TWO_SIDED|95.0|-0.05|0.19|||ANOVA|||1 Hour: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.19|-0.05|0.273
72482521|NCT01794923|144492118|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.1||||0.069|TWO_SIDED|95.0|-0.25|0.01|||ANOVA|||1 Hour: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.01|-0.25|0.069
72511137|NCT01798706|144552753|SUPERIORITY_OR_OTHER||LS Mean Difference|-5.05|STANDARD_ERROR_OF_MEAN|0.464|<|0.0001|TWO_SIDED|95.0|-5.96|-4.132||Threshold for significance at 0.05 level. Testing sequence continued only when previous endpoint was statistically significant at 0.05.|ANCOVA||Lixisenatide vs Placebo|Analysis was performed using ANCOVA model with treatment groups, randomization strata of Week -1 HbA1c (\<8.0, ≥8.0%), randomization strata of basal insulin use at screening, randomization strata of Week -1 eGFR (≥30 to \<60, ≥60 ml/min/1.73 m\^2), and country as fixed effects and baseline 2-hour PPG value as a covariate. Hierarchical testing procedure was used to control type I error at 0.05. Testing was then performed sequentially in the order the endpoints were reported.||-4.132|-5.96|< 0.0001
72511138|NCT01798706|144552754|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.96|STANDARD_ERROR_OF_MEAN|0.219|<|0.0001|TWO_SIDED|95.0|-1.39|-0.527||Threshold for significance at 0.05 level.|ANCOVA||Lixisenatide vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using ANCOVA model with treatment groups, randomization strata of Week -1 HbA1c (\<8.0, ≥8.0%), randomization strata of basal insulin use at screening, randomization strata of Week -1 eGFR (≥30 to \<60, ≥60 ml/min/1.73 m\^2), and country as fixed effects and baseline 7-point SMPG value as a covariate.||-0.527|-1.39|< 0.0001
72511139|NCT01798706|144552755|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.32|STANDARD_ERROR_OF_MEAN|0.278|<|0.0001|TWO_SIDED|95.0|-1.862|-0.769||Threshold for significance at 0.05 level.|ANCOVA||Lixisenatide vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using ANCOVA model with treatment groups, randomization strata of Week -1 HbA1c (\<8.0, ≥8.0%), randomization strata of basal insulin use at screening, randomization strata of Week -1 eGFR (≥30 to \<60, ≥60 ml/min/1.73 m\^2), and country as fixed effects and baseline body weight value as a covariate.||-0.769|-1.862|< 0.0001
72511140|NCT01798706|144552756|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.31|STANDARD_ERROR_OF_MEAN|0.262||0.2347|TWO_SIDED|95.0|-0.828|0.204||Threshold for significance at 0.05 level.|ANCOVA||Lixisenatide vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using ANCOVA model with treatment groups, randomization strata of Week -1 HbA1c (\<8.0, ≥8.0%), randomization strata of basal insulin use at screening, randomization strata of Week -1 eGFR (≥30 to \<60, ≥60 ml/min/1.73 m\^2), and country as fixed effects and baseline FPG value as a covariate.||0.204|-0.828|0.2347
72511141|NCT03238235|144552769|SUPERIORITY||Log Difference of the least square means|0.04||||0.8282|TWO_SIDED|95.0|-0.3|0.38||ANCOVA model was performed considering the difference between log of total fibrosis and log baseline values as dependent variable; log baseline value was included as covariate, treatment and concomitant steroid use as independent class variables.|ANCOVA|||total fibrosis at visit 11||0.38|-0.30|0.8282
72511142|NCT03238235|144552769|SUPERIORITY|Mixed model was performed considering the difference between log Visit 11 and log baseline values as dependent variable; log baseline as covariate, treatment was included as independent class variable and treatment by sequence interaction. The sequence of biopsy site (R-L, L-R) was included as a fixed effect and subject as a random effect. If the treatment by sequence interaction was p\>0.10, then the model without the interaction term is presented.|Log Difference of Least Square Means|-0.11||||0.6465|TWO_SIDED|95.0|-0.59|0.37|||Mixed Models Analysis|||A Mixed Model was fitted to the data in order to evaluate the difference in total fibrosis between biopsy sites||0.37|-0.59|0.6465
72511143|NCT03238235|144552770|SUPERIORITY||Log Difference of Least Square Means|-0.05||||0.1991|TWO_SIDED|95.0|-0.12|0.03||ANCOVA model was performed considering baseline fat fraction of vastus lateralis or fat fraction in the soleus value as covariate and treatment and concomitant steroid use at baseline as independent class variables.|ANCOVA|||Vastus lateralis||0.03|-0.12|0.1991
72511144|NCT03238235|144552770|SUPERIORITY||difference of the least square means|-0.27||||0.7849|TWO_SIDED|95.0|-2.22|1.69||ANCOVA model was performed considering baseline fat fraction of vastus lateralis or fat fraction in the soleus value as covariate and treatment and concomitant steroid use at baseline as independent class variables.|ANCOVA|||Soleus||1.69|-2.22|0.7849
72511145|NCT03238235|144552771|SUPERIORITY||Difference of Least Square Means|-1.35||||0.0149|TWO_SIDED|95.0|-2.43|-0.28||ANCOVA model was performed considering baseline Fat Fraction of lower limb muscles value as covariate and treatment and concomitant steroid use at baseline as independent class variables.|ANCOVA|||Whole thigh at visit 11||-0.28|-2.43|0.0149
72511146|NCT03238235|144552771|SUPERIORITY||Difference of Least Square Means|-1.96||||0.0022|TWO_SIDED|95.0|-3.18|-0.75||ANCOVA model was performed considering baseline Fat Fraction of lower limb muscles value as covariate and treatment and concomitant steroid use at baseline as independent class variables|ANCOVA|||Quadriceps at visit 11||-0.75|-3.18|0.0022
72511147|NCT03238235|144552771|SUPERIORITY||Difference of least square means|-0.58||||0.4869|TWO_SIDED|95.0|-2.24|1.08||ANCOVA model was performed considering baseline Fat Fraction of lower limb muscles value as covariate and treatment and concomitant steroid use at baseline as independent class variables.|ANCOVA|||Hamstrings at visit 11||1.08|-2.24|0.4869
72511148|NCT03238235|144552771|SUPERIORITY||Difference of Least Square Means|-1.59||||0.0939|TWO_SIDED|95.0|-3.47|0.29||ANCOVA model was performed considering baseline Fat Fraction of lower limb muscles value as covariate and treatment and concomitant steroid use at baseline as independent class variables.|ANCOVA|||Triceps Surae at Visit 11||0.29|-3.47|0.0939
72511149|NCT03238235|144552771|SUPERIORITY||Difference of Least Square Means|-0.89||||0.1579|TWO_SIDED|95.0|-2.13|0.36||ANCOVA model was performed considering baseline Fat Fraction of lower limb muscles value as covariate and treatment and concomitant steroid use at baseline as independent class variables.|ANCOVA|||Pelvis girdle at visit 11||0.36|-2.13|0.1579
72567009|NCT01490931|144664784|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P value adjusted with Bonferroni corrections for multiple comparisons|t-test, 2 sided|||Changes in pain intensity on the VAS were statistically compared to baseline pain utilizing paired t tests with Bonferroni corrections for multiple comparisons. The median onsets of first perceptible and meaningful relief (with 95% confidence intervals) were calculated and then used to construct Kaplan-Meier Curves of the distribution of pain relief times.||||<0.0001
72567010|NCT01490931|144664788|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||Changes in pain intensity on the VAS were statistically compared to baseline pain utilizing paired t tests with Bonferroni corrections for multiple comparisons. The median onsets of first perceptible and meaningful relief (with 95% confidence intervals) were calculated and then used to construct Kaplan-Meier Curves of the distribution of pain relief times.||||<0.0001
72511150|NCT03238235|144552772|SUPERIORITY||Difference of Least Square Means|0.4||||0.777|TWO_SIDED|95.0|-2.45|3.26||ANCOVA model was performed considering baseline CSA as covariate, treatment and concomitant steroid use at baseline as independent class variables.|ANCOVA|||Whole Thigh at visit 11||3.26|-2.45|0.7770
72402127|NCT00666757|144311376|SUPERIORITY_OR_OTHER|||||||0.03||95.0|||||Mixed Models Analysis|||Only those patients who had at least moderate pain at baseline (defined as baseline BPI Average 24-Hour Pain Score greater than or equal to 3). Repeated Measures Analysis. Treatment comparisons will include the contrast between treatment groups at 12-Week endpoint.||||0.03
72511151|NCT03238235|144552772|SUPERIORITY||Difference of Least Square Means|-0.09||||0.8926|TWO_SIDED|95.0|-1.35|1.18||ANCOVA model was performed considering baseline CSA as covariate, treatment and concomitant steroid use at baseline as independent class variables|ANCOVA|||Quadriceps at Visit 11||1.18|-1.35|0.8926
72511152|NCT03238235|144552772|SUPERIORITY||Difference of Least Square Means|0.35||||0.572|TWO_SIDED|95.0|-0.88|1.58||ANCOVA model was performed considering baseline CSA as covariate, treatment and concomitant steroid use at baseline as independent class variables.|ANCOVA|||Medial Thigh at Visit 11||1.58|-0.88|0.5720
72511153|NCT03238235|144552772|SUPERIORITY||Difference of Least Square Means|0.11||||0.8386|TWO_SIDED|95.0|-0.97|1.18||ANCOVA model was performed considering baseline CSA as covariate, treatment and concomitant steroid use at baseline as independent class variables.|ANCOVA|||Hamstrings at Visit 11||1.18|-0.97|0.8386
72511154|NCT03238235|144552772|SUPERIORITY||Difference of Least Square Means|-0.22||||0.8591|TWO_SIDED|95.0|-2.68|2.25||ANCOVA model was performed considering baseline CSA as covariate, treatment and concomitant steroid use at baseline as independent class variables|ANCOVA|||Triceps Surae at Visit 11||2.25|-2.68|0.8591
72511155|NCT03238235|144552772|SUPERIORITY||Difference of Least Square Means|0.32||||0.7392|TWO_SIDED|95.0|-1.6|2.24|||ANCOVA|||Pelvis Girdle at Visit 11||2.24|-1.60|0.7392
72511156|NCT03238235|144552773|SUPERIORITY||Difference of Least Square Means|1.37||||0.0375|TWO_SIDED|95.0|0.08|2.65||ANCOVA model was performed considering baseline Contractile Area value as covariate, treatment and concomitant steroid use at baseline as independent class variables.|ANCOVA|||Whole Thigh at Visit 11||2.65|0.08|0.0375
72511157|NCT03238235|144552773|SUPERIORITY||difference of least square means|0.63||||0.0528|TWO_SIDED|95.0|-0.01|1.27||ANCOVA model was performed considering baseline Contractile Area value as covariate, treatment and concomitant steroid use at baseline as independent class variables.|ANCOVA|||Quadriceps at Visit 11||1.27|-0.01|0.0528
72511158|NCT03238235|144552773|SUPERIORITY||Difference of Least Square Means|0.36||||0.2012|TWO_SIDED|95.0|-0.2|0.91||ANCOVA model was performed considering baseline Contractile Area value as covariate, treatment and concomitant steroid use at baseline as independent class variables|ANCOVA|||Medial Thigh at Visit 11||0.91|-0.20|0.2012
72511159|NCT03238235|144552773|SUPERIORITY||Difference of Least Square Means|0.75||||0.4676|TWO_SIDED|95.0|-1.33|2.83||ANCOVA model was performed considering baseline Contractile Area value as covariate, treatment and concomitant steroid use at baseline as independent class variables.|ANCOVA|||Triceps Surae at Visit 11||2.83|-1.33|0.4676
72511160|NCT03238235|144552773|SUPERIORITY||Difference of Least Square Means|0.54||||0.1549|TWO_SIDED|95.0|-0.21|1.3||ANCOVA model was performed considering baseline Contractile Area value as covariate, treatment and concomitant steroid use at baseline as independent class variables.|ANCOVA|||Pelvis Girdle at Visit 11||1.30|-0.21|0.1549
72511161|NCT03238235|144552774|SUPERIORITY||Difference of Least Square Means|-619.2||||0.324|TWO_SIDED|95.0|-1872.37|633.98||ANCOVA model was performed considering baseline biopsy histological parameters (Slide III) value as covariate, treatment and concomitant steroid use at baseline as independent class variables|ANCOVA|||CSA Type II at Visit 11||633.98|-1872.37|0.3240
72511162|NCT03238235|144552774|SUPERIORITY||Difference of Least Square Means|-572.54||||0.307|TWO_SIDED|95.0|-1690.73|545.64||ANCOVA model was performed considering baseline biopsy histological parameters (Slide III) value as covariate, treatment and concomitant steroid use at baseline as independent class variables|ANCOVA|||Total CSA at Visit 11||545.64|-1690.73|0.3070
72511163|NCT03238235|144552775|SUPERIORITY||Log Difference of Least Square Means|-0.27||||0.1055|TWO_SIDED|95.0|-0.59|0.06||ANCOVA model was performed considering baseline Biopsy histological parameters (Slide I) value as covariate, treatment and concomitant steroid use at baseline as independent class variables.|ANCOVA|||Fibers with nuclear centralizations (%) at Visit 11||0.06|-0.59|0.1055
72511164|NCT03238235|144552775|SUPERIORITY||Difference of Least Square Means|-2.23||||0.8846|TWO_SIDED|95.0|-33.05|28.59||ANCOVA model was performed considering baseline biopsy histological parameters (Slide II) value as covariate, treatment and concomitant steroid use at baseline as independent class variables.|ANCOVA|||Total number of fibers at Visit 11 (slide II)||28.59|-33.05|0.8846
72511165|NCT03238235|144552775|SUPERIORITY||Difference of Least Square Means|4.72||||0.4054|TWO_SIDED|95.0|-6.62|16.06||ANCOVA model was performed considering baseline biopsy histological parameters (Slide III) value as covariate, treatment and concomitant steroid use at baseline as independent class variables|ANCOVA|||Total number of fibers (Slide III)||16.06|-6.62|0.4054
72511166|NCT03238235|144552776|SUPERIORITY||Difference of Least Square Means|2.45||||0.634|TWO_SIDED|95.0|-7.87|12.77||ANCOVA model was performed considering baseline Biopsy histological parameters (Slide I) value as covariate, treatment and concomitant steroid use at baseline as independent class variables|ANCOVA|||||12.77|-7.87|0.6340
72511167|NCT03238235|144552777|SUPERIORITY||Log Difference of Least Square Means|-0.14||||0.4893|TWO_SIDED|95.0|-0.54|0.26|||ANCOVA|||||0.26|-0.54|0.4893
72511168|NCT03238235|144552778|SUPERIORITY||Log Difference of Least Square Means|-0.34||||0.1498|TWO_SIDED|95.0|-0.81|0.13||This model was performed considering baseline biopsy histological parameters (Slide I) value as covariate, treatment and concomitant steroid use at baseline as independent class variables.|ANCOVA|||||0.13|-0.81|0.1498
72402128|NCT00666757|144311377|SUPERIORITY_OR_OTHER|||||||0.03||95.0|||||Mixed Models Analysis|||Repeated Measures Analysis. Treatment comparisons will include the contrast between treatment groups at 12-Week endpoint.||||0.03
72402129|NCT00666757|144311378|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||Mixed Models Analysis|||Repeated Measures Analysis. Treatment comparisons will include the contrast between treatment groups at 12-Week endpoint.||||0.002
72402130|NCT00666757|144311379|SUPERIORITY_OR_OTHER|||||||0.01||95.0|||||Mixed Models Analysis|||Repeated Measures Analysis. Treatment comparisons will include the contrast between treatment groups at endpoint.||||0.01
72402131|NCT00666757|144311380|SUPERIORITY_OR_OTHER|||||||0.07||95.0||||Between group P-value|ANCOVA|||||||0.07
72402132|NCT00666757|144311381|SUPERIORITY_OR_OTHER|||||||0.34||95.0||||Between group P-value|ANCOVA|||||||0.34
72402133|NCT00666757|144311382|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||Mixed Models Analysis|||Repeated Measures Analysis. Treatment comparisons will include the contrast between treatment groups at endpoint.||||0.02
72511169|NCT03238235|144552779|SUPERIORITY||Log Difference of Least Square Means|0.06||||0.0602|TWO_SIDED|95.0|0.0|0.13||Least squares mean is obtained from the mixed effects model for repeated measures with treatment, visit, visit by treatment interaction and concomitant steroid use at baseline as fixed effect; baseline value is included as a covariate.|Mixed Models Analysis|||Standing and transfers (D1) at Visit 11||0.13|-0.00|0.0602
72511170|NCT03238235|144552779|SUPERIORITY||Log Difference of Least Square Means|0.0||||0.5906|TWO_SIDED|95.0|-0.01|0.01||Least squares mean is obtained from the mixed effects model for repeated measures with treatment, visit, visit by treatment interaction and concomitant steroid use at baseline as fixed effect; baseline value is included as a covariate.|Mixed Models Analysis|||Axial and proximal motor function (D2) at Visit 11||0.01|-0.01|0.5906
72511171|NCT03238235|144552779|SUPERIORITY||Log Difference of Least Square Means|0.0||||0.7799|TWO_SIDED|95.0|-0.01|0.01||Least squares mean is obtained from the mixed effects model for repeated measures with treatment, visit, visit by treatment interaction and concomitant steroid use at baseline as fixed effect; baseline value is included as a covariate.|Mixed Models Analysis|||Distal motor function (D3) at Visit 11||0.01|-0.01|0.7799
72511172|NCT03238235|144552779|SUPERIORITY||Log Difference of Least Square Means|0.01||||0.1116|TWO_SIDED|95.0|0.0|0.03||Least squares mean is obtained from the mixed effects model for repeated measures with treatment, visit, visit by treatment interaction and concomitant steroid use at baseline as fixed effect; baseline value is included as a covariate.|Mixed Models Analysis|||Total Score at Visit 11||0.03|-0.00|0.1116
72511173|NCT03238235|144552780|SUPERIORITY||Log Difference of Least Square Means|-0.07||||0.4346|TWO_SIDED|95.0|-0.23|0.1||Least squares mean is obtained from the mixed effects model for repeated measures with treatment, visit, visit by treatment interaction and concomitant steroid use at baseline as fixed effect; baseline value is included as a covariate|Mixed Models Analysis|||Time to Walk/Run 10 meters at Visit 11||0.10|-0.23|0.4346
72511174|NCT03238235|144552781|SUPERIORITY||Log Difference of Least Square Means|-0.02||||0.8914|TWO_SIDED|95.0|-0.32|0.28|||Mixed Models Analysis|||Time to climb 4 standard steps (sec) at visit 11||0.28|-0.32|0.8914
72511175|NCT03238235|144552782|SUPERIORITY||Difference of Least Square Means|0.62||||0.7629|TWO_SIDED|95.0|-3.51|4.75||Least squares mean is obtained from the mixed effects model for repeated measures with treatment, visit, visit by treatment interaction and concomitant steroid use at baseline as fixed effect; baseline value is included as a covariate.|Mixed Models Analysis|||Time to rise from floor at Visit 11||4.75|-3.51|0.7629
72402134|NCT00666757|144311383|SUPERIORITY_OR_OTHER|||||||0.01||95.0|||||Mixed Models Analysis|||Repeated Measures Analysis. Treatment comparisons will include the contrast between treatment groups at endpoint.||||0.01
72402135|NCT00666757|144311384|SUPERIORITY_OR_OTHER|||||||0.97||95.0|||||Mixed Models Analysis|||Repeated Measures Analysis. Treatment comparisons will include the contrast between treatment groups at endpoint.||||0.97
72402136|NCT00666757|144311385|SUPERIORITY_OR_OTHER|||||||0.32||95.0|||||Mixed Models Analysis|||Repeated Measures Analysis. Treatment comparisons will include the contrast between treatment groups at endpoint.||||0.32
72402137|NCT00666757|144311386|SUPERIORITY_OR_OTHER|||||||0.12||95.0||||Between group P-value|ANCOVA|||Transformed absolute score||||0.12
72402138|NCT00666757|144311387|SUPERIORITY_OR_OTHER|||||||0.16||95.0||||Between group P-value|ANCOVA|||Transformed Absolute Score||||0.16
72402139|NCT00666757|144311388|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||Mixed Models Analysis|||Repeated Measures Analysis. Treatment comparisons will include the contrast between treatment groups at endpoint.||||0.002
72402140|NCT00666757|144311389|SUPERIORITY_OR_OTHER|||||||0.53||95.0|||||Mixed Models Analysis|||Repeated Measures Analysis. Treatment comparisons will include the contrast between treatment groups at endpoint.||||0.53
72402141|NCT01231581|144311390|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.94||||0.352|TWO_SIDED|95.0|0.66|1.32|||Log Rank||Hazard ratios are estimated using a Pike estimator.|||1.32|0.66|0.352
72402142|NCT00159588|144311449|SUPERIORITY|||||||0.056||||||Between-group analysis|Kruskal-Wallis|||Kruskal-Wallis test||||0.056
72402143|NCT00159588|144311450|SUPERIORITY|Between-group analysis||||||0.012||||||Between-group analysis|t-test, 2 sided|Kruskal-Wallis test||Kruskal-Wallis test||||0.012
72402144|NCT05352815|144311459|SUPERIORITY|Change in HbA1c from baseline to week 52 is analysed using an analysis of covariance (ANCOVA) model with region and randomised treatment as fixed factors and baseline HbA1c as covariate. Missing HbA1c values at week 52 are imputed by using multiple imputation. Each imputed dataset is analysed separately and estimates are combined using Rubin's rules.|Treatment difference|-0.66|||<|0.0001|TWO_SIDED|95.0|-0.76|-0.57|||ANCOVA|||||-0.57|-0.76|<0.0001
72402145|NCT02759120|144311469|SUPERIORITY||Hazard Ratio (HR)|1.04||||0.83|TWO_SIDED|95.0|0.71|1.53|||Regression, Cox|||||1.53|0.71|0.83
72402146|NCT02759120|144311470|SUPERIORITY||Hazard Ratio (HR)|1.11||||0.65|TWO_SIDED|95.0|0.7|1.78|||Regression, Cox|||||1.78|0.70|0.65
72402147|NCT02759120|144311471|SUPERIORITY||Hazard Ratio (HR)|1.34||||0.25|TWO_SIDED|95.0|0.82|2.17|||Regression, Cox|||||2.17|0.82|0.25
72402148|NCT02759120|144311472|SUPERIORITY||Hazard Ratio (HR)|1.36||||0.13|TWO_SIDED|95.0|0.91|2.01|||Regression, Cox|||||2.01|0.91|0.13
72402149|NCT02759120|144311473|SUPERIORITY||Risk Ratio (RR)|1.21||||0.4|TWO_SIDED|95.0|0.78|1.89|||Regression, Cox|||||1.89|0.78|0.40
72402150|NCT02759120|144311474|SUPERIORITY||Risk Ratio (RR)|1.29||||0.16|TWO_SIDED|95.0|0.9|1.83|||Regression, Cox|||||1.83|0.90|0.16
72511176|NCT03238235|144552783|SUPERIORITY||Log Difference of Least Square Means|-0.01||||0.8106|TWO_SIDED|95.0|-0.11|0.08||Least squares mean is obtained from the mixed effects model for repeated measures with treatment, visit, visit by treatment interaction and concomitant steroid use at baseline as fixed effect; baseline value is included as a covariate|Mixed Models Analysis|||Maximum distance walked after 6 minutes at Visit 11||0.08|-0.11|0.8106
72511177|NCT03238235|144552784|SUPERIORITY|||||||0.1626||||||P-value is obtained from the two-sided Cochran-Mantel-Haenszel chi-squared test, stratified for concomitant steroid use at baseline|Cochran-Mantel-Haenszel|||\<10% worsening at visit 11||||0.1626
72511178|NCT03238235|144552787|SUPERIORITY||Difference of Least Square Means|3.57||||0.5099|TWO_SIDED|95.0|-7.27|14.41||Least squares mean is obtained from the mixed effects model for repeated measures with treatment, visit, visit by treatment interaction and concomitant steroid use at baseline as fixed effect; baseline value is included as a covariate.|ANCOVA|||Left Knee Extension (N) at Visit 11||14.41|-7.27|0.5099
72511179|NCT03238235|144552787|SUPERIORITY||Difference of Least Square Means|1.16||||0.7355|TWO_SIDED|95.0|-5.73|8.06||Least squares mean is obtained from the mixed effects model for repeated measures with treatment, visit, visit by treatment interaction and concomitant steroid use at baseline as fixed effect; baseline value is included as a covariate.|ANCOVA|||Right Knee Extension (N) at Visit 11||8.06|-5.73|0.7355
72511180|NCT03238235|144552787|SUPERIORITY||Difference of Least Square Means|3.92||||0.6037|TWO_SIDED|95.0|-11.22|19.06||Least squares mean is obtained from the mixed effects model for repeated measures with treatment, visit, visit by treatment interaction and concomitant steroid use at baseline as fixed effect; baseline value is included as a covariate.|ANCOVA|||Left Elbow Flexion (N) at Visit 11||19.06|-11.22|0.6037
72511181|NCT03238235|144552787|SUPERIORITY||Difference of Least Square Means|4.1||||0.6178|TWO_SIDED|95.0|-12.35|20.55||Least squares mean is obtained from the mixed effects model for repeated measures with treatment, visit, visit by treatment interaction and concomitant steroid use at baseline as fixed effect; baseline value is included as a covariate.|ANCOVA|||Right Elbow Flexion (N) at Visit 11||20.55|-12.35|0.6178
72511182|NCT03238235|144552790|SUPERIORITY||log difference of Least Square Means|-0.03||||0.1165|TWO_SIDED|95.0|-0.06|0.01||ANCOVA model was performed considering baseline fat fraction of lower limb muscles value as covariate and treatment and concomitant steroids use at baseline as independent class variables|ANCOVA|||Medial Thigh at visit 11||0.01|-0.06|0.1165
72511183|NCT03238235|144552791|SUPERIORITY||Log difference of Least Square Means|0.05||||0.1939|TWO_SIDED|95.0|-0.02|0.12||ANCOVA model was performed considering baseline CSA as covariate and treatment and concomitant steroids use at baseline as independent class variables|ANCOVA|||Hamstrings at Visit 11||0.12|-0.02|0.1939
72511184|NCT03238235|144552792|SUPERIORITY||Log difference of Least Square Means|0.01||||0.9493|TWO_SIDED|95.0|-0.29|0.3||ANCOVA model was performed considering baseline biopsy histological parameters (slide III) value as covariate, treatment and concomitant steroids use at baseline as independent class variables|ANCOVA|||CSA Type I||0.30|-0.29|0.9493
72511185|NCT03238235|144552793|SUPERIORITY||Log difference of Least Square Means|0.05||||0.6265|TWO_SIDED|95.0|-0.16|0.26||ANCOVA model was performed considering baseline biopsy histological parameters (slide I) value as covariate, treatment and concomitant steroids use at baseline as independent class variables|ANCOVA|||Total number of Fibers at Visit 11 (slide I)||0.26|-0.16|0.6265
72511186|NCT03238235|144552793|SUPERIORITY||Log difference of Least Square Means|-0.44||||0.1562|TWO_SIDED|95.0|-1.05|0.17||ANCOVA model was performed considering baseline biopsy histological parameters (slide II) value as covariate, treatment and concomitant steroids use at baseline as independent class variables|ANCOVA|||Regenerative Fibers (%) at Visit 11||0.17|-1.05|0.1562
72511187|NCT05896761|144552794|OTHER||Ratio of geometric least square mean|0.926|||||TWO_SIDED|90.0|0.831|1.03||||||||1.03|0.831|
72511188|NCT05896761|144552794|OTHER||Ratio of geometric least square mean|0.929|||||TWO_SIDED|90.0|0.816|1.06||||||||1.06|0.816|
72511189|NCT05896761|144552795|OTHER||Ratio of geometric least square mean|1.06|||||TWO_SIDED|90.0|0.966|1.17||||||||1.17|0.966|
72511190|NCT05896761|144552795|OTHER||Ratio of geometric least square mean|1.18|||||TWO_SIDED|90.0|1.07|1.29||||||||1.29|1.07|
72511191|NCT05896761|144552796|OTHER||Ratio of geometric least square mean|1.35|||||TWO_SIDED|90.0|1.22|1.49||||||||1.49|1.22|
72511192|NCT05896761|144552796|OTHER||Ratio of geometric least square mean|1.1|||||TWO_SIDED|90.0|0.975|1.24||||||||1.24|0.975|
72511193|NCT05896761|144552797|OTHER||Ratio of geometric least square mean|1.26|||||TWO_SIDED|90.0|1.12|1.4||||||||1.40|1.12|
72511194|NCT05896761|144552797|OTHER||Ratio of geometric least square mean|1.18|||||TWO_SIDED|90.0|1.09|1.28||||||||1.28|1.09|
72511195|NCT05896761|144552798|OTHER||Ratio of geometric least square mean|1.21|||||TWO_SIDED|90.0|1.13|1.3||||||||1.30|1.13|
72511196|NCT05896761|144552798|OTHER||Ratio of geometric least square mean|1.09|||||TWO_SIDED|90.0|1.0|1.2||||||||1.20|1.00|
72511197|NCT05896761|144552799|OTHER||Ratio of geometric least square mean|1.15|||||TWO_SIDED|90.0|1.07|1.23||||||||1.23|1.07|
72511198|NCT05896761|144552799|OTHER||Ratio of geometric least square mean|1.29|||||TWO_SIDED|90.0|1.2|1.38||||||||1.38|1.20|
72511199|NCT05896761|144552800|OTHER||Ratio of geometric least square mean|1.16|||||TWO_SIDED|90.0|1.08|1.25||||||||1.25|1.08|
72511200|NCT05896761|144552800|OTHER||Ratio of geometric least square mean|0.983|||||TWO_SIDED|90.0|0.89|1.09||||||||1.09|0.890|
72511201|NCT05896761|144552801|OTHER||Ratio of geometric least square mean|1.06|||||TWO_SIDED|90.0|0.991|1.13||||||||1.13|0.991|
72511202|NCT05896761|144552801|OTHER||Ratio of geometric least square mean|1.04|||||TWO_SIDED|90.0|0.974|1.12||||||||1.12|0.974|
72511203|NCT05896761|144552802|OTHER||Ratio of geometric least square mean|1.18|||||TWO_SIDED|90.0|1.11|1.25||||||||1.25|1.11|
72511204|NCT05896761|144552802|OTHER||Ratio of geometric least square mean|1.06|||||TWO_SIDED|90.0|0.989|1.14||||||||1.14|0.989|
72511205|NCT05896761|144552803|OTHER||Ratio of geometric least square mean|1.08|||||TWO_SIDED|90.0|1.03|1.12||||||||1.12|1.03|
72511206|NCT05896761|144552803|OTHER||Ratio of geometric least square mean|1.04|||||TWO_SIDED|90.0|0.997|1.08||||||||1.08|0.997|
72511207|NCT05896761|144552804|OTHER||Ratio of geometric least square mean|1.13|||||TWO_SIDED|90.0|1.08|1.19||||||||1.19|1.08|
72402151|NCT02759120|144311475|SUPERIORITY||Mean Difference (Final Values)|1.14||||0.19|TWO_SIDED|95.0|-0.56|2.83|||Regression, Cox|||||2.83|-0.56|0.19
72511208|NCT05896761|144552804|OTHER||Ratio of geometric least square mean|1.04|||||TWO_SIDED|90.0|0.97|1.11||||||||1.11|0.97|
72511209|NCT05896761|144552805|OTHER||Ratio of geometric least square mean|1.06|||||TWO_SIDED|90.0|1.02|1.11||||||||1.11|1.02|
72511210|NCT05896761|144552805|OTHER||Ratio of geometric least square mean|1.06|||||TWO_SIDED|90.0|1.01|1.11||||||||1.11|1.01|
72511211|NCT03552549|144552841|OTHER||Hazard Ratio (HR)|0.71|||||TWO_SIDED|95.0|0.28|1.77|||||Hazard ratio presented as PEG-Intron/INTRON A; HR \<1 indicates treatment effect in favor of PEG-Intron.|||1.77|0.28|
72511212|NCT05515601|144552893|OTHER|A linear fixed-effects model is used to estimate the relative bioavailability.|Ratio of Geometric least squares mean|0.986|||||TWO_SIDED|90.0|0.929|1.05||||||||1.05|0.929|
72511213|NCT05515601|144552894|OTHER|A linear fixed-effects model is used to estimate the relative bioavailability.|Ratio of Geometric least squares mean|1.01|||||TWO_SIDED|90.0|0.948|1.08||||||||1.08|0.948|
72511214|NCT05515601|144552895|OTHER|A linear fixed-effects model is used to estimate the relative bioavailability|Ratio of Geometric least squares mean|1.02|||||TWO_SIDED|90.0|0.96|1.09||||||||1.09|0.960|
72511215|NCT00777491|144552896|OTHER|There was no formal comparison of the two treatment arms.||||||||||||||||The confidence interval of the rate was calculated by Clopper-Pearson's exact binomial confidence intervals methods with one-sided type I error of 0.1. The study required 32 analyzable patients in each arm, which would warrant a 10% chance of observing a percentage of patients without distant metastasis by 3 years of less than 75% if the true rate was 86%. With the actual number of evaluable patients, the study instead warrants a 13-14% chance.|If the percentage of patients without distant metastasis by 3 years for either arm was greater than or equal to 75%, then it would be strongly considered as a potential arm in a subsequent phase III study, assuming treatment delivery and adverse events (AEs) were acceptable. If both arms met the criteria, then the treatment arm with less toxicity would be chosen.|||
72511216|NCT00777491|144552899|SUPERIORITY||Odds Ratio (OR)|0.493||||0.3|TWO_SIDED|95.0|0.129|1.881||Two-sided significance level of 0.05|Regression, Logistic|Univariate analysis|Reference arm = 5-FU and Cisplatin + BID Irradiation|||1.881|0.129|0.30
72511217|NCT00777491|144552900|SUPERIORITY||Odds Ratio (OR)|1.5||||0.75|TWO_SIDED|95.0|0.426|5.277||Two-sided significance level of 0.05|Regression, Logistic|Univariable analysis|Reference arm = 5-FU and Cisplatin + BID irradiation|||5.277|0.426|0.75
72511218|NCT04160468|144552916|SUPERIORITY||Risk Difference (RD)|-10.6||||0.392|TWO_SIDED|95.0|-33.6|12.4|||Fisher Exact|||||12.4|-33.6|0.392
72511219|NCT01187901|144552918|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
72511220|NCT01187901|144552919|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
72511221|NCT01187901|144552920|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
72511222|NCT01187901|144552921|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
72567011|NCT01490931|144664789|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||Changes in pain intensity on the VAS were statistically compared to baseline pain utilizing paired t tests with Bonferroni corrections for multiple comparisons. The median onsets of first perceptible and meaningful relief (with 95% confidence intervals) were calculated and then used to construct Kaplan-Meier Curves of the distribution of pain relief times.||||<0.0001
72567012|NCT01490931|144664790|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||Changes in pain intensity on the VAS were statistically compared to baseline pain utilizing paired t tests with Bonferroni corrections for multiple comparisons. The median onsets of first perceptible and meaningful relief (with 95% confidence intervals) were calculated and then used to construct Kaplan-Meier Curves of the distribution of pain relief times.||||<0.0001
72567013|NCT01490931|144664791|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||Changes in pain intensity on the VAS were statistically compared to baseline pain utilizing paired t tests with Bonferroni corrections for multiple comparisons. The median onsets of first perceptible and meaningful relief (with 95% confidence intervals) were calculated and then used to construct Kaplan-Meier Curves of the distribution of pain relief times.||||<0.0001
72567014|NCT01490931|144664792|SUPERIORITY_OR_OTHER||||||<|1|||||||t-test, 2 sided|||Changes in pain intensity on the VAS were statistically compared to baseline pain utilizing paired t tests with Bonferroni corrections for multiple comparisons. The median onsets of first perceptible and meaningful relief (with 95% confidence intervals) were calculated and then used to construct Kaplan-Meier Curves of the distribution of pain relief times.||||<0001
72402152|NCT02759120|144311476|SUPERIORITY||Mean Difference (Final Values)|0.83||||0.51|TWO_SIDED|95.0|-1.67|3.35|||Regression, Cox|||||3.35|-1.67|0.51
72402153|NCT02759120|144311477|SUPERIORITY||Risk Ratio (RR)|0.71||||0.13|TWO_SIDED|95.0|0.46|1.11|||Regression, Cox|||||1.11|0.46|0.13
72402154|NCT02759120|144311478|SUPERIORITY||Mean Difference (Final Values)|-0.62||||0.76|TWO_SIDED|95.0|-4.64|3.39|||Regression, Cox|||||3.39|-4.64|0.76
72511223|NCT01187901|144552922|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
72511224|NCT01187901|144552923|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
72511225|NCT00088634|144552924|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0|||||ANCOVA|||Comparisons between SM-13496 and placebo will be performed by means of a 2-way analysis of covariance (ANCOVA) model with treatment group and study center as factors, and baseline BPRS score as a covariate. Ninety-five percent (95%) confidence intervals will be constructed using the variability estimates from the ANCOVA model.||||<0.05
72511226|NCT00088634|144552925|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0|||||ANCOVA|||Comparisons between SM-13496 and placebo will be performed by means of a 2-way analysis of covariance (ANCOVA) model with treatment group and study center as factors, and baseline PANSS score as a covariate. Ninety-five percent (95%) confidence intervals will be constructed using the variability estimates from the ANCOVA model.||||<0.05
72511227|NCT00088634|144552926|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0|||||ANCOVA|||Comparisons between SM-13496 and placebo will be performed by means of a 2-way analysis of covariance (ANCOVA) model with treatment group and study center as factors, and baseline CGI-S score as a covariate. Ninety-five percent (95%) confidence intervals will be constructed using the variability estimates from the ANCOVA model.||||<0.05
72402155|NCT02759120|144311479|SUPERIORITY||Mean Difference (Final Values)|0.11||||0.54|TWO_SIDED|95.0|-0.24|0.46|||Regression, Cox|||||0.46|-0.24|0.54
72402156|NCT02759120|144311480|SUPERIORITY||Mean Difference (Final Values)|0.01||||0.99|TWO_SIDED|95.0|-0.79|0.8|||Regression, Linear|||||0.80|-0.79|0.99
72511228|NCT00088634|144552927|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0|||||ANCOVA|||Comparisons between SM-13496 and placebo will be performed by means of a 2-way analysis of covariance (ANCOVA) model with treatment group and study center as factors, and baseline MADRS score as a covariate. Ninety-five percent (95%) confidence intervals will be constructed using the variability estimates from the ANCOVA model.||||<0.05
72567015|NCT01490931|144664793|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||Changes in pain intensity on the VAS were statistically compared to baseline pain utilizing paired t tests with Bonferroni corrections for multiple comparisons. The median onsets of first perceptible and meaningful relief (with 95% confidence intervals) were calculated and then used to construct Kaplan-Meier Curves of the distribution of pain relief times.||||<0.0001
72511229|NCT00540436|144552928|SUPERIORITY_OR_OTHER||Mean change|33.49||||||95.0|15.231|51.744||||||||51.744|15.231|
72511230|NCT00540436|144552929|SUPERIORITY_OR_OTHER||Mean change|46.82||||||95.0|24.566|69.076||||||||69.076|24.566|
72511231|NCT03255291|144552938|SUPERIORITY|A Dunnett adjustment was used to adjust for multiple comparisons||||||0.0288|||||||ANCOVA|Covariates: sex, race, age, education, health literacy, season, risk display problem, acceptability, self-reported health, and baseline exercise.||The investigators tested whether weekly minutes of exercise at 90 day follow-up was higher in the exercise mental imagery condition than in the sleep mental imagery condition||||0.0288
72511232|NCT03255291|144552938|SUPERIORITY|-A Dunnett adjustment was used to adjust for multiple comparisons||||||0.3329|||||||ANCOVA|Covariates: sex, race, age, education, health literacy, season, risk display problem, acceptability, self-reported health, and baseline exercise.||-The investigators tested whether weekly minutes of exercise differed among the three risk display formats: risk ladder, table, and alphanumeric text.||||0.3329
72511233|NCT03255291|144552938|SUPERIORITY|-A Dunnett adjustment was used to adjust for multiple comparisons||||||0.0215|||||||ANCOVA|Covariates: sex, race, age, education, health literacy, season, risk display problem, acceptability, self-reported health, and baseline exercise.||-The investigators tested whether weekly minutes of exercise was influenced by an interaction between risk display format and mental imagery behavior||||0.0215
72511234|NCT03255291|144552939|SUPERIORITY|||||||0.0333||||||-A Dunnett adjustment was used to adjust for multiple comparisons|ANCOVA|Covariates were sex, race, age, education, numeracy, and graph literacy.||-This study was designed as a 3X2 factorial design and only the risk display format intervention (risk ladder, table, or text) was looked at for this outcome, as participants had not yet received the mental imagery intervention, thus it could not affect this outcome. A Dunnett adjustment was used to adjust for multiple comparisons.||||0.0333
72511235|NCT03255291|144552940|SUPERIORITY|||||||0.4946||||||-A Dunnett adjustment was used to adjust for multiple comparisons|ANCOVA|Covariates were sex, race, age, education, numeracy, and graph literacy.||This study was designed as a 3X2 factorial design \& only the risk display format intervention (risk ladder, table, or text) was looked at for this outcome, as participants had not yet received the mental imagery intervention, thus it could not affect this outcome.||||0.4946
72511236|NCT03255291|144552941|SUPERIORITY|||||||0.1397|||||||ANCOVA|Covariates were sex, race, age, education, numeracy, and graph literacy.||This study was designed as a 3X2 factorial design \& only the risk display format intervention (risk ladder, table, or text) was looked at for this outcome, as participants had not yet received the mental imagery intervention, thus it could not affect this outcome.||||0.1397
72511237|NCT03255291|144552942|SUPERIORITY|||||||0.007||||||Covariates: sex, race, age, education, risk display issue, health literacy, season, acceptability, self-reported health, adherence, baseline exercise|Mixed Models Analysis|||The secondary outcomes are hypothesized mediators of the effect of exercise-related mental imagery activities on future exercise behavior (e.g., exercise mental imagery will increase future exercise behavior by increasing exercise maintenance self-efficacy). Because these analyses are relevant only for the exercise condition, and the dichotomous mental imagery variable includes both exercise and sleep, it is not appropriate to include the dichtomous mental imagery variable in this analysis.||||0.0070
72567016|NCT01490931|144664794|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||Changes in pain intensity on the VAS were statistically compared to baseline pain utilizing paired t tests with Bonferroni corrections for multiple comparisons. The median onsets of first perceptible and meaningful relief (with 95% confidence intervals) were calculated and then used to construct Kaplan-Meier Curves of the distribution of pain relief times.||||<0.0001
72402157|NCT02759120|144311481|SUPERIORITY||Mean Difference (Final Values)|-0.62||||0.76|TWO_SIDED|95.0|-4.64|3.39|||Regression, Cox|||||3.39|-4.64|0.76
72402158|NCT02759120|144311482|SUPERIORITY||Mean Difference (Final Values)|0.01||||0.63|TWO_SIDED|95.0|-0.031|0.051|||Regression, Cox|||||0.051|-0.031|0.63
72402159|NCT02759120|144311483|SUPERIORITY||Mean Difference (Final Values)|0.018||||0.15|TWO_SIDED|95.0|-0.007|0.043|||Regression, Cox|||||0.043|-0.007|0.15
72402160|NCT02759120|144311484|SUPERIORITY||Mean Difference (Final Values)|0.52||||0.53|TWO_SIDED|95.0|-1.11|2.15|||Regression, Cox|||||2.15|-1.11|0.53
72402161|NCT02759120|144311485|SUPERIORITY||Mean Difference (Final Values)|0.3||||0.75|TWO_SIDED|95.0|-1.61|2.2|||Regression, Linear|||||2.20|-1.61|0.75
72402162|NCT04452331|144311566|SUPERIORITY|||||||0.06|||||||Regression, Linear|Adjusted for clinical site||Diastolic BP||||0.06
72402163|NCT04452331|144311566|SUPERIORITY|||||||0.9|||||||Regression, Linear|||Systolic BP||||0.90
72402164|NCT04452331|144311568|SUPERIORITY|||||||0.29|||||||Regression, Linear|||||||.29
72402165|NCT04452331|144311569|SUPERIORITY|||||||0.1|||||||Regression, Logistic|||||||.10
72402166|NCT04452331|144311570|SUPERIORITY|||||||0.44|||||||Regression, Linear|||||||0.44
72402167|NCT04452331|144311571|SUPERIORITY|||||||0.01|||||||Regression, Linear|||||||0.01
72511238|NCT03255291|144552943|SUPERIORITY|||||||0.8793||||||Covariates: sex, race, age, education, risk display issue, health literacy, season, acceptability, self-reported health, adherence, baseline exercise|Mixed Models Analysis|||The secondary outcomes are hypothesized mediators of the effect of exercise-related mental imagery activities on future exercise behavior (e.g., exercise mental imagery will increase future exercise behavior by increasing exercise recovery self-efficacy). Because these analyses are relevant only for the exercise condition, and the dichotomous mental imagery variable includes both exercise and sleep, it is not appropriate to include the dichtomous mental imagery variable in this analysis.||||0.8793
72511239|NCT03255291|144552944|SUPERIORITY|||||||0.4673||||||Covariates: sex, race, age, education, risk display issue, health literacy, season, acceptability, self-reported health, adherence, baseline exercise|Mixed Models Analysis|||The secondary outcomes are hypothesized mediators of the effect of the exercise-related mental imagery activities on future exercise behavior (e.g., exercise mental imagery will increase future exercise behavior by increasing exercise affective attitudes). Because these analyses are relevant only for the exercise condition, and the dichotomous mental imagery variable includes both exercise and sleep, it is not appropriate to include the dichotomous mental imagery variable in this analysis.||||0.4673
72511240|NCT03255291|144552945|SUPERIORITY|||||||0.1916||||||Covariates: sex, race, age, education, risk display issue, health literacy, season, acceptability, self-reported health, adherence, baseline exercise|Mixed Models Analysis|||The secondary outcomes are hypothesized mediators of the effect of the exercise-related mental imagery activities on future exercise behavior (e.g., exercise mental imagery will increase future exercise behavior by increasing exercise unpleasant feelings). Because these analyses are relevant only for the exercise condition, and the dichotomous mental imagery variable includes both exercise and sleep, it is not appropriate to include the dichotomous mental imagery variable in this analysis.||||0.1916
72511241|NCT03255291|144552946|SUPERIORITY|||||||0.8661||||||Covariates: sex, race, age, education, risk display issue, health literacy, season, acceptability, self-reported health, adherence, baseline exercise|Mixed Models Analysis|||The secondary outcomes are hypothesized mediators of the effect of the exercise-related mental imagery activities on future exercise behavior (e.g., exercise mental imagery will increase future exercise behavior by increasing exercise imagery vividness). Because these analyses are relevant only for the exercise condition, and the dichotomous mental imagery variable includes both exercise and sleep, it is not appropriate to include the dichotomous mental imagery variable in this analysis.||||0.8661
72511242|NCT03255291|144552947|SUPERIORITY|||||||0.0711||||||Covariates: sex, race, age, education, risk display issue, health literacy, season, acceptability, self-reported health, adherence, baseline exercise|Mixed Models Analysis|||The secondary outcomes are hypothesized mediators of the effect of the exercise-related mental imagery activities on future exercise behavior (e.g., exercise mental imagery will increase future exercise behavior by increasing exercise action planning). Because these analyses are relevant only for the exercise condition, and the dichotomous mental imagery variable includes both exercise and sleep, it is not appropriate to include the dichotomous mental imagery variable in this analysis.||||0.0711
72511243|NCT03255291|144552948|SUPERIORITY|||||||0.0365||||||Covariates: sex, race, age, education, risk display issue, health literacy, season, acceptability, self-reported health, adherence, baseline exercise|Mixed Models Analysis|||The secondary outcomes are hypothesized mediators of the effect of the exercise-related mental imagery activities on future exercise behavior (e.g., exercise mental imagery will increase future exercise behavior by increasing exercise coping planning). Because these analyses are relevant only for the exercise condition, and the dichotomous mental imagery variable includes both exercise and sleep, it is not appropriate to include the dichotomous mental imagery variable in this analysis.||||0.0365
72511244|NCT03255291|144552949|SUPERIORITY|||||||0.1511||||||Covariates: sex, race, age, education, risk display issue, health literacy, season, acceptability, self-reported health, adherence, baseline exercise|Mixed Models Analysis|||The secondary outcomes are hypothesized mediators of the effect of the exercise-related mental imagery activities on future exercise behavior (e.g., exercise mental imagery will increase future exercise behavior by increasing exercise action self-efficacy). Because these analyses are relevant only for the exercise condition, and the dichotomous mental imagery variable includes both exercise and sleep, it is not appropriate to include the dichotomous mental imagery variable in this analysis.||||0.1511
72511245|NCT00471445|144552954|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.174|STANDARD_ERROR_OF_MEAN|0.19||0.363|TWO_SIDED|95.0|-0.548|0.201|||ANCOVA|||Tested at the two-sided 0.05 significance level.||0.201|-0.548|0.363
72511246|NCT00962039|144552968|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.01||||0.92|TWO_SIDED|95.0|-0.12|0.1||Analyses were conducted over 8 week follow-up.|Chi-squared|||||0.10|-0.12|0.92
72511247|NCT00962039|144552969|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.08||||0.034|TWO_SIDED|95.0|-0.15|-0.01|||Chi-squared|||||-0.01|-0.15|0.034
72511248|NCT00962039|144552970|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.03||||0.261|TWO_SIDED|95.0|-0.07|0.02|||t-test, 2 sided|||||0.02|-0.07|0.261
72511249|NCT00962039|144552971|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.09||||0.519|TWO_SIDED|95.0|-0.36|0.18|||t-test, 2 sided|||||0.18|-0.36|0.519
72511250|NCT00962039|144552972|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.12||||0.704|TWO_SIDED|95.0|-0.77|0.52|||t-test, 2 sided|||||0.52|-0.77|0.704
72511251|NCT00962039|144552973|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.59||||0.046|TWO_SIDED|95.0|0.01|1.17|||t-test, 2 sided|||||1.17|0.01|0.046
72511252|NCT03229759|144552999|SUPERIORITY||Mean Difference (Final Values)|1.48|||||TWO_SIDED|95.0|0.88|2.08||||||Test on abdomen Average treatment effect was calculated using a linear regression model for each body site was used for primary analysis. In the model, the response was the post-treatment log10 bacterial counts and predictors were the treatment effect as a fixed effect and the pre-treatment log10 bacterial counts as a covariate.||2.08|0.88|
72511253|NCT03229759|144552999|SUPERIORITY||Mean Difference (Final Values)|1.34|||||TWO_SIDED|95.0|0.72|1.96||||||Tested on the abdomen Analysis was performed based on deferral letters from the FDA. Average treatment effect was calculated using a linear regression model for each body site was used for primary analysis. In the model, the response was the post-treatment log10 bacterial counts and predictors were the treatment effect as a fixed effect and the pre-treatment log10 bacterial counts as a covariate.||1.96|0.72|
72567017|NCT01490931|144664795|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||Changes in pain intensity on the VAS were statistically compared to baseline pain utilizing paired t tests with Bonferroni corrections for multiple comparisons. The median onsets of first perceptible and meaningful relief (with 95% confidence intervals) were calculated and then used to construct Kaplan-Meier Curves of the distribution of pain relief times.||||<0.0001
72567018|NCT00754494|144664816|SUPERIORITY_OR_OTHER|||||||0.762|TWO_SIDED||||||General Linear Model|||A log-transformation of pEGFR was utilized in primary analyses because of the highly skewed distribution observed in this outcome. The general linear model was used to estimate and compare the relative change in median pEGFR with adjustment for actin as a normalizing factor. The estimated relative change (post:pre) in the median, corresponding 95% confidence interval, and p-value for testing the null hypothesis of equal medians comparing pre- and post-measurements were reported.||||0.762
72567019|NCT00754494|144664816|SUPERIORITY_OR_OTHER|||||||0.125|TWO_SIDED||||||General Linear Model|||A log-transformation of pEGFR was utilized in primary analyses because of the highly skewed distribution observed in this outcome. The general linear model was used to estimate and compare the relative change in median pEGFR with adjustment for actin as a normalizing factor. The estimated relative change (post:pre) in the median, corresponding 95% confidence interval, and p-value for testing the null hypothesis of equal medians comparing pre- and post-measurements were reported.||||0.125
72511254|NCT03229759|144552999|SUPERIORITY||Mean Difference (Final Values)|1.93|||||TWO_SIDED|95.0|1.38|2.47||||||Groin||2.47|1.38|
72511255|NCT03229759|144552999|SUPERIORITY||Mean Difference (Final Values)|1.26|||||TWO_SIDED|95.0|0.73|1.79||||||Groin||1.79|0.73|
72511256|NCT03050359|144553002|NON_INFERIORITY|If the lower bound of the 95% CI was ≥-6%, the DU healing rate for TAK-438 was considered to be noninferior to that seen with lansoprazole.|Exact (Clopper-Pearson)|0.4|||||TWO_SIDED|95.0|-2.998|3.791||||||||3.791|-2.998|
72511257|NCT03050359|144553003|NON_INFERIORITY|If the lower bound of the 95% CI was ≥-10%, the HP eradication rate for TAK-438 was considered to be noninferior to that seen with lansoprazole.|Exact (Clopper-Pearson)|4.7|||||TWO_SIDED|95.0|-1.281|10.69||||||||10.690|-1.281|
72511258|NCT03050359|144553004|NON_INFERIORITY|If the lower bound of the 95% CI was ≥-6%, the DU healing rate for TAK-438 was considered to be noninferior to that seen with lansoprazole.|Exact (Clopper-Pearson)|0.7|||||TWO_SIDED|95.0|-4.901|6.319||||||||6.319|-4.901|
72511259|NCT03050359|144553005|OTHER||Difference in percentages|-4.1|||||TWO_SIDED|95.0|-15.579|7.344||||||Epigastric Pain (Postprandial)||7.344|-15.579|
72567020|NCT00754494|144664816|SUPERIORITY_OR_OTHER|||||||0.855|TWO_SIDED||||||General Linear Model|||A log-transformation of pEGFR was utilized in primary analyses because of the highly skewed distribution observed in this outcome. The general linear model was used to estimate and compare the relative change in median pEGFR with adjustment for actin as a normalizing factor. The estimated relative change (post:pre) in the median, corresponding 95% confidence interval, and p-value for testing the null hypothesis of equal medians comparing pre- and post-measurements were reported.||||0.855
72567021|NCT00754494|144664817|SUPERIORITY_OR_OTHER|||||||0.369|TWO_SIDED||||||General Linear Model|||A log-transformation of total EGFR was utilized in primary analyses because of the highly skewed distribution observed in this outcome. The general linear model was used to estimate and compare the relative change in median total EGFR with adjustment for actin as a normalizing factor. The estimated relative change (post:pre) in the median, corresponding 95% confidence interval, and p-value for testing the null hypothesis of equal medians comparing pre- and post-measurements were reported.||||0.369
72402168|NCT04452331|144311572|SUPERIORITY|||||||0.01|||||||Regression, Logistic|||||||0.01
72511260|NCT03050359|144553005|OTHER||Difference in percentages|1.6|||||TWO_SIDED|95.0|-5.23|8.422||||||Epigastric Pain (Fasting/Nocturnal)||8.422|-5.230|
72511261|NCT03050359|144553005|OTHER||Difference in percentages|-4.0|||||TWO_SIDED|95.0|-17.338|9.401||||||Abdominal Bloating||9.401|-17.338|
72511262|NCT03050359|144553005|OTHER||Difference in percentages|-9.3|||||TWO_SIDED|95.0|-26.334|7.815||||||Nausea/Vomiting||7.815|-26.334|
72511263|NCT03050359|144553005|OTHER||Difference in percentages|4.5|||||TWO_SIDED|95.0|-4.159|13.25||||||Heartburn||13.250|-4.159|
72511264|NCT03050359|144553005|OTHER||Difference in percentages|-9.1|||||TWO_SIDED|95.0|-21.104|2.922||||||Lack of Appetite||2.922|-21.104|
72511265|NCT02614287|144553007|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1
72511266|NCT02614287|144553011|SUPERIORITY|||||||0.215|||||||Fisher Exact|||TE ADA Positive (TE ADA+)||||.215
72511267|NCT02614287|144553012|SUPERIORITY||LSMean Difference|-0.86|STANDARD_ERROR_OF_MEAN|0.46||0.6|TWO_SIDED|95.0|-1.76|0.04|||Mixed Models Analysis|||||0.04|-1.76|0.60
72511268|NCT02614287|144553013|SUPERIORITY||LSMean Difference|0.09|STANDARD_ERROR_OF_MEAN|0.41||0.835|TWO_SIDED|95.0|-0.72|0.89|||Mixed Models Analysis|||||0.89|-0.72|.835
72511269|NCT02614287|144553014|SUPERIORITY||Odds Ratio (OR)|1.467||||0.063|TWO_SIDED|95.0|0.979|2.197|||CPLRM|CPLRM: Categorical pseudo likelihood-based repeated measures model||||2.197|0.979|.063
72511270|NCT02614287|144553015|SUPERIORITY||LSMean Difference|0.04|STANDARD_ERROR_OF_MEAN|0.51||0.937|TWO_SIDED|95.0|-0.96|1.04|||Mixed Models Analysis|||||1.04|-0.96|.937
72511271|NCT02614287|144553016|SUPERIORITY||LSMean Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.1||0.073|TWO_SIDED|95.0|-0.4|0.02|||Mixed Models Analysis|||||0.02|-0.40|0.073
72511272|NCT02614287|144553017|SUPERIORITY||LSMean Difference|0.91|STANDARD_ERROR_OF_MEAN|2.82||0.747|TWO_SIDED|95.0|-4.65|6.47|||Mixed Models Analysis|||||6.47|-4.65|.747
72511273|NCT02614287|144553018|SUPERIORITY||LSMean Difference|1.98|STANDARD_ERROR_OF_MEAN|1.55||0.203|TWO_SIDED|95.0|-1.07|5.03|||Mixed Models Analysis|||Total Score||5.03|-1.07|0.203
72511274|NCT02614287|144553018|SUPERIORITY||LSMean Difference|1.85|STANDARD_ERROR_OF_MEAN|1.59||0.247|TWO_SIDED|95.0|-1.29|4.98|||Mixed Models Analysis|||Role Function-Restrictive Domain Score||4.98|-1.29|.247
72482522|NCT01794923|144492118|SUPERIORITY_OR_OTHER_LEGACY|||||||0.716|TWO_SIDED||||||ANOVA|||2 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||||0.716
72482523|NCT01794923|144492118|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.0||||0.735|TWO_SIDED|95.0|-0.15|0.11|||ANOVA|||2 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.11|-0.15|0.735
72482524|NCT01794923|144492118|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.1||||0.414|TWO_SIDED|95.0|-0.19|0.08|||ANOVA|||2 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.08|-0.19|0.414
72482525|NCT01794923|144492118|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.0||||0.652|TWO_SIDED|95.0|-0.11|0.17|||ANOVA|||2 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.17|-0.11|0.652
72482526|NCT01794923|144492118|SUPERIORITY_OR_OTHER_LEGACY|||||||0.622|TWO_SIDED||||||ANOVA|||3 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||||0.622
72482527|NCT01794923|144492118|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.0||||0.83|TWO_SIDED|95.0|-0.17|0.21|||ANOVA|||3 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.21|-0.17|0.830
72482528|NCT01794923|144492118|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.1||||0.442|TWO_SIDED|95.0|-0.26|0.11|||ANOVA|||3 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.11|-0.26|0.442
72482529|NCT01794923|144492118|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.1||||0.358|TWO_SIDED|95.0|-0.11|0.29|||ANOVA|||3 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.29|-0.11|0.358
72482530|NCT01794923|144492118|SUPERIORITY_OR_OTHER_LEGACY|||||||0.714|TWO_SIDED||||||ANOVA|||4 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||||0.714
72482531|NCT01794923|144492118|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.0||||0.683|TWO_SIDED|95.0|-0.29|0.19|||ANOVA|||4 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.19|-0.29|0.683
72482532|NCT01794923|144492118|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.1||||0.413|TWO_SIDED|95.0|-0.34|0.14|||ANOVA|||4 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.14|-0.34|0.413
72482533|NCT01794923|144492118|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.1||||0.699|TWO_SIDED|95.0|-0.21|0.31|||ANOVA|||4 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.31|-0.21|0.699
72482534|NCT01794923|144492118|SUPERIORITY_OR_OTHER_LEGACY|||||||0.244|TWO_SIDED||||||ANOVA|||5 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||||0.244
72482535|NCT01794923|144492118|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.0||||0.833|TWO_SIDED|95.0|-0.21|0.26|||ANOVA|||5 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.26|-0.21|0.833
72482536|NCT01794923|144492118|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.2||||0.156|TWO_SIDED|95.0|-0.41|0.07|||ANOVA|||5 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.07|-0.41|0.156
72482537|NCT01794923|144492118|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.2||||0.128|TWO_SIDED|95.0|-0.06|0.46|||ANOVA|||5 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.46|-0.06|0.128
72482538|NCT01794923|144492118|SUPERIORITY_OR_OTHER_LEGACY|||||||0.359|TWO_SIDED||||||ANOVA|||6 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||||0.359
72482539|NCT01794923|144492118|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.2||||0.278|TWO_SIDED|95.0|-0.12|0.43|||ANOVA|||6 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.43|-0.12|0.278
72511275|NCT02614287|144553018|SUPERIORITY||LSMean Difference|1.26|STANDARD_ERROR_OF_MEAN|1.49||0.399|TWO_SIDED|95.0|-1.67|4.19|||Mixed Models Analysis|||Role Function-Preventive Domain Score||4.19|-1.67|0.399
72482540|NCT01794923|144492118|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.1||||0.699|TWO_SIDED|95.0|-0.33|0.22|||ANOVA|||6 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.22|-0.33|0.699
72482541|NCT01794923|144492118|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.2||||0.172|TWO_SIDED|95.0|-0.09|0.5|||ANOVA|||6 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.50|-0.09|0.172
72482542|NCT01794923|144492118|SUPERIORITY_OR_OTHER_LEGACY|||||||0.515|TWO_SIDED||||||ANOVA|||7 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||||0.515
72482543|NCT01794923|144492118|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.1||||0.527|TWO_SIDED|95.0|-0.19|0.37|||ANOVA|||7 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.37|-0.19|0.527
72482544|NCT01794923|144492118|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.1||||0.545|TWO_SIDED|95.0|-0.37|0.19|||ANOVA|||7 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.19|-0.37|0.545
72482545|NCT01794923|144492118|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.2||||0.25|TWO_SIDED|95.0|-0.12|0.47|||ANOVA|||7 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.47|-0.12|0.250
72482546|NCT01794923|144492118|SUPERIORITY_OR_OTHER_LEGACY|||||||0.568|TWO_SIDED||||||ANOVA|||8 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||||0.568
72482547|NCT01794923|144492118|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.1||||0.381|TWO_SIDED|95.0|-0.16|0.41|||ANOVA|||8 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.41|-0.16|0.381
72482548|NCT01794923|144492118|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.0||||0.863|TWO_SIDED|95.0|-0.31|0.26|||ANOVA|||8 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.26|-0.31|0.863
72482549|NCT01794923|144492118|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.2||||0.33|TWO_SIDED|95.0|-0.16|0.46|||ANOVA|||8 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.46|-0.16|0.330
72511276|NCT02614287|144553018|SUPERIORITY||LSMean Difference|3.09|STANDARD_ERROR_OF_MEAN|1.8||0.88|TWO_SIDED|95.0|-0.46|6.64|||Mixed Models Analysis|||Emotional Function Domain Score||6.64|-0.46|0.88
72567022|NCT00754494|144664817|SUPERIORITY_OR_OTHER|||||||0.085|TWO_SIDED||||||General Linear Model|||A log-transformation of total EGFR was utilized in primary analyses because of the highly skewed distribution observed in this outcome. The general linear model was used to estimate and compare the relative change in median total EGFR with adjustment for actin as a normalizing factor. The estimated relative change (post:pre) in the median, corresponding 95% confidence interval, and p-value for testing the null hypothesis of equal medians comparing pre- and post-measurements were reported.||||0.085
72567023|NCT00754494|144664817|SUPERIORITY_OR_OTHER|||||||0.233|TWO_SIDED||||||General Linear Model|||A log-transformation of total EGFR was utilized in primary analyses because of the highly skewed distribution observed in this outcome. The general linear model was used to estimate and compare the relative change in median total EGFR with adjustment for actin as a normalizing factor. The estimated relative change (post:pre) in the median, corresponding 95% confidence interval, and p-value for testing the null hypothesis of equal medians comparing pre- and post-measurements were reported.||||0.233
72567024|NCT00754494|144664818|SUPERIORITY_OR_OTHER|||||||0.651|TWO_SIDED||||||General Linear Model|||A log-transformation of pEGFR was utilized in primary analyses because of the highly skewed distribution observed in this outcome. The general linear model was used to estimate and compare the relative change in median pEGFR with adjustment for actin as a normalizing factor. The estimated relative change (post:pre) in the median, corresponding 95% confidence interval, and p-value for testing the null hypothesis of equal medians comparing pre- and post-measurements were reported.||||0.651
72567025|NCT00754494|144664818|SUPERIORITY_OR_OTHER|||||||0.03|TWO_SIDED||||||General Linear Model|||A log-transformation of pEGFR was utilized in primary analyses because of the highly skewed distribution observed in this outcome. The general linear model was used to estimate and compare the relative change in median pEGFR with adjustment for actin as a normalizing factor. The estimated relative change (post:pre) in the median, corresponding 95% confidence interval, and p-value for testing the null hypothesis of equal medians comparing pre- and post-measurements were reported.||||0.030
72567026|NCT00754494|144664818|SUPERIORITY_OR_OTHER|||||||0.261|TWO_SIDED||||||General Linear Model|||A log-transformation of pEGFR was utilized in primary analyses because of the highly skewed distribution observed in this outcome. The general linear model was used to estimate and compare the relative change in median pEGFR with adjustment for actin as a normalizing factor. The estimated relative change (post:pre) in the median, corresponding 95% confidence interval, and p-value for testing the null hypothesis of equal medians comparing pre- and post-measurements were reported.||||0.261
72567027|NCT00754494|144664819|SUPERIORITY_OR_OTHER|||||||0.654|TWO_SIDED||||||General Linear Model|||A log-transformation of total EGFR was utilized in primary analyses because of the highly skewed distribution observed in this outcome. The general linear model was used to estimate and compare the relative change in median total EGFR with adjustment for actin as a normalizing factor. The estimated relative change (post:pre) in the median, corresponding 95% confidence interval, and p-value for testing the null hypothesis of equal medians comparing pre- and post-measurements were reported.||||0.654
72567028|NCT00754494|144664819|SUPERIORITY_OR_OTHER|||||||0.03|TWO_SIDED||||||General Linear Model|||A log-transformation of total EGFR was utilized in primary analyses because of the highly skewed distribution observed in this outcome. The general linear model was used to estimate and compare the relative change in median total EGFR with adjustment for actin as a normalizing factor. The estimated relative change (post:pre) in the median, corresponding 95% confidence interval, and p-value for testing the null hypothesis of equal medians comparing pre- and post-measurements were reported.||||0.030
72567029|NCT00754494|144664819|SUPERIORITY_OR_OTHER|||||||0.083|TWO_SIDED||||||General Linear Model|||A log-transformation of total EGFR was utilized in primary analyses because of the highly skewed distribution observed in this outcome. The general linear model was used to estimate and compare the relative change in median total EGFR with adjustment for actin as a normalizing factor. The estimated relative change (post:pre) in the median, corresponding 95% confidence interval, and p-value for testing the null hypothesis of equal medians comparing pre- and post-measurements were reported.||||0.083
72482550|NCT01794923|144492118|SUPERIORITY_OR_OTHER_LEGACY|||||||0.167|TWO_SIDED||||||ANOVA|||9 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||||0.167
72567030|NCT02480582|144664889|SUPERIORITY_OR_OTHER||||||<|0.01||||||Where significant effects were obtained post hoc analyses, with a Bonferroni correction for multiple comparisons were conducted.|ANOVA|Null hypothesis is that there was no difference in energy intake between almonds, cheese savouries and no food.||||||<0.01
72567031|NCT02480582|144664890|SUPERIORITY_OR_OTHER||||||<|0.05||||||Where significant effects were obtained post hoc analyses, with a Bonferroni correction for multiple comparisons were conducted.|ANOVA|Null hypothesis is that there was no difference in wanting for high fat foods between almonds, cheese savouries and no food.||||||<0.05
72567032|NCT02480582|144664891|SUPERIORITY_OR_OTHER||||||<|0.001||||||Where significant effects were obtained post hoc analyses, with a Bonferroni correction for multiple comparisons were conducted.|ANOVA|Null hypothesis is that there was no difference in hunger AUC between almonds, cheese savouries and no food.||||||<0.001
72567033|NCT02480582|144664892|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|Null hypothesis is that there was no difference in energy intake between almonds, cheese savouries and no food.||"Energy intake measured by ad-libitum test meals (breakfast, lunch, dinner) during each intervention condition.~Null hypothesis is that there was no difference in total energy intake between almonds, cheese savouries and no food."||||<0.05
72567034|NCT03407118|144664952|SUPERIORITY||ratio of least square means|0.967|||||TWO_SIDED|95.0|0.803|1.17||||||||1.17|0.803|
72567035|NCT03050918|144664954|SUPERIORITY|||||||0.05||||||we used the O'Brian-Fleming α-spending function, allowing for an α-level of significance of 0.005 and 0.048 for the interim and final analyses, respectively.|Wilcoxon (Mann-Whitney)|||||||.05
72567036|NCT03050918|144664955|SUPERIORITY|||||||0.05||||||We used the O'Brian-Fleming α-spending function, allowing for an α-level of significance of 0.005 and 0.048 for the interim and final analyses, respectively.|Chi-squared|||||||0.05
72567037|NCT03050918|144664955|SUPERIORITY|||||||0.05||||||We used the O'Brian-Fleming α-spending function, allowing for an α-level of significance of 0.005 and 0.048 for the interim and final analyses, respectively.|Wilcoxon (Mann-Whitney)|||||||.05
72482551|NCT01794923|144492118|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.2||||0.165|TWO_SIDED|95.0|-0.09|0.5|||ANOVA|||9 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.50|-0.09|0.165
72482552|NCT01794923|144492118|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.1||||0.564|TWO_SIDED|95.0|-0.39|0.21|||ANOVA|||9 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.21|-0.39|0.564
72482553|NCT01794923|144492118|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.3||||0.068|TWO_SIDED|95.0|-0.02|0.62|||ANOVA|||9 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.62|-0.02|0.068
72511277|NCT01156597|144553021|SUPERIORITY_OR_OTHER|||||||0.05|||||||ANOVA|The percent change of HDL and triglycerides from baseline between groups was evaluated by ANOVA using baseline, 12 week and 24 week values||||||0.05
72511278|NCT00833248|144553030|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was to be established if the treatment difference in adjusted (for baseline volume, and baseline total IPSS) mean percentage reduction was significantly greater (two-sided at α=0.05 level) than Δ = 10 points (non-inferiority margin) in both the FAS and PP analyses sets.|Mean Difference (Final Values)|-0.3||||0.8942|TWO_SIDED|95.0|-4.74|4.14|||ANCOVA|The baseline IPSS and baseline Prostate volume were used as covariates and treatment was used as a factor in the analysis.||FAS. Estimates from analysis of variance with treatment as factors and baseline IPSS and baseline Prostate volume as covariates.||4.14|-4.74|0.8942
72511279|NCT00833248|144553031|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was to be established if the treatment difference in adjusted (for baseline volume, and baseline total IPSS) mean percentage reduction was significantly greater (two-sided at α=0.05 level) than Δ = 10 points (non-inferiority margin) in both the FAS and PP analyses sets.|Mean Difference (Final Values)|-0.268||||0.9123|TWO_SIDED|95.0|-5.05|4.52|||ANCOVA|The baseline IPSS and baseline Prostate volume were used as covariates and treatment was used as a factor in the analysis.||PP analysis set. Estimates from analysis of variance with treatment as factors and baseline IPSS and baseline Prostate volume as covariates.||4.52|-5.05|0.9123
72511280|NCT03007485|144553057|SUPERIORITY||Odds Ratio (OR)|1.0|||<|0.05|TWO_SIDED|95.0||||Reported p-value was calculated|t-test, 2 sided|||Sample size and power calculation was a composite of COPD-related hospital readmissions or death within 6 months of discharge. First level of analysis was the ITT, which included all the patients randomly assigned to an arm at the beginning of the study (excluding those who were found to not meet inclusion criteria for referral). The second included all the patients medically cleared and third included all the patients who were medically cleared and who had participated in at least 1 PR session.|"The primary outcome was a composite of COPD-related hospital readmissions or death within 6 months of discharge (binary: yes/no). Logistic regression was used to compare the primary outcome in terms of the OR of event rates between the 2 arms, in 3 sets of models (per each of the 3 aforementioned level of analyses):~* Model 1: Treatment arm only with no other covariates added to the model~* Model 2: Treatment arm, adjusted for race and clinical site (stratification variables)~* Model 3: Treatment arm, adjusted for race, clinical site, and risk factors reported in the literature to be associated with the primary outcome, for explanatory purposes To examine the role of adherence on the primary outcome, we included adherence as a binary variable and as a continuous variable (percentage of sessions attended) in the 3 models."|||<.05
72511281|NCT00401622|144553070|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.56|STANDARD_ERROR_OF_MEAN|7.51||0.31|TWO_SIDED|95.0|-7.24|22.36|||t-test, 2 sided|||||22.36|-7.24|0.31
72511282|NCT00401622|144553071|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.17|STANDARD_ERROR_OF_MEAN|0.11||0.45|TWO_SIDED|95.0|-0.38|0.04|||ANCOVA|Visit 1 A1c measurement used as the covariate||Change in A1C from baseline to week 52 between the OneTouch® Ultra®2 and control BGMS||0.04|-0.38|0.45
72567038|NCT03050918|144664956|SUPERIORITY|||||||0.05||||||We used the O'Brian-Fleming α-spending function, allowing for an α-level of significance of 0.005 and 0.048 for the interim and final analyses, respectively.|Chi-squared|||||||0.05
72567039|NCT03050918|144664956|SUPERIORITY|||||||0.05||||||We used the O'Brian-Fleming α-spending function, allowing for an α-level of significance of 0.005 and 0.048 for the interim and final analyses, respectively.|Chi-squared|||||||.05
72482554|NCT01794923|144492118|SUPERIORITY_OR_OTHER_LEGACY|||||||0.131|TWO_SIDED||||||ANOVA|||10 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||||0.131
72402169|NCT04452331|144311573|SUPERIORITY|||||||0.54|||||||Regression, negative binomial|||||||0.54
72482555|NCT01794923|144492118|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.2||||0.119|TWO_SIDED|95.0|-0.06|0.56|||ANOVA|||10 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.56|-0.06|0.119
72482556|NCT01794923|144492118|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.1||||0.616|TWO_SIDED|95.0|-0.39|0.23|||ANOVA|||10 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.23|-0.39|0.616
72511283|NCT00520676|144553072|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.45|||<|0.001|TWO_SIDED|95.0|0.34|0.6||The comparison was conducted at a 1-sided significance level of 0.05.|Log Rank|Note that the 2-sided p-value for log rank is reported, which is \<0.001, hence 1-sided p-value is \<0.001.|Cox regression model is used for HR estimate.|||0.60|0.34|<0.001
72482557|NCT01794923|144492118|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.3||||0.056|TWO_SIDED|95.0|-0.01|0.66|||ANOVA|||10 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.66|-0.01|0.056
72482558|NCT01794923|144492118|SUPERIORITY_OR_OTHER_LEGACY|||||||0.255|TWO_SIDED||||||ANOVA|||11 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||||0.255
72511284|NCT00520676|144553073|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.01||||0.934|TWO_SIDED|95.0|0.72|1.42||The comparison was conducted at a 2-sided significance level of 0.05.|Log Rank||Cox regression model is used for hazard ratio (HR) estimate.|||1.42|0.72|0.934
72511285|NCT00520676|144553074|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.96||||0.8|TWO_SIDED|95.0|0.72|1.29||The comparison was conducted at a 2-sided significance level of 0.05.|Log Rank|Cox regression model is used for hazard ratio (HR) estimate.||||1.29|0.72|0.800
72511286|NCT00520676|144553075|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.71||||0.081|TWO_SIDED|95.0|0.93|3.15||The comparison of tumor response rates was conducted at a 2-sided significance level of 0.05.|Fisher Exact|Tumor response rate= # participants with a confirmed best response of CR or PR / # of participants who qualify for the analysis population.|Logistic regression model is used for odds ratio (OR) estimate.|||3.15|0.93|0.081
72567040|NCT03050918|144664957|SUPERIORITY|||||||0.05||||||We used the O'Brian-Fleming α-spending function, allowing for an α-level of significance of 0.005 and 0.048 for the interim and final analyses, respectively.|Chi-squared|||||||.05
72482559|NCT01794923|144492118|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.2||||0.144|TWO_SIDED|95.0|-0.08|0.57|||ANOVA|||11 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.57|-0.08|0.144
72482560|NCT01794923|144492118|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.0||||0.935|TWO_SIDED|95.0|-0.34|0.31|||ANOVA|||11 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.31|-0.34|0.935
72482561|NCT01794923|144492118|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.3||||0.153|TWO_SIDED|95.0|-0.1|0.61|||ANOVA|||11 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.61|-0.10|0.153
72482562|NCT01794923|144492118|SUPERIORITY_OR_OTHER_LEGACY|||||||0.128|TWO_SIDED||||||ANOVA|||12 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||||0.128
72511287|NCT00520676|144553076|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.87||||0.641|TWO_SIDED|95.0|0.49|1.55||The comparison was conducted at a 2-sided significance level of 0.05.|Log Rank||Cox regression model is used for hazard ratio (HR) estimate.|||1.55|0.49|0.641
72511288|NCT00520676|144553077|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.53|||<|0.001|TWO_SIDED|95.0|0.4|0.71||The comparison was conducted at a 2-sided significance level of 0.05.|Log Rank||Cox regression model is used for unadjusted hazard ratio (HR) estimate.|||0.71|0.40|<0.001
72511289|NCT00520676|144553078|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.49|||<|0.001|TWO_SIDED|95.0|0.35|0.66||The comparison was conducted at a 2-sided significance level of 0.05.|Log Rank||Cox regression model is used for unadjusted hazard ratio (HR) estimate.|||0.66|0.35|<0.001
72511290|NCT00115349|144553092|SUPERIORITY_OR_OTHER|||||||0.89||0.0|||||Mixed Models Analysis|Linear mixed models with treatment, time, and treatment x time interaction were used, allowing for random participant-specific intercepts and slopes.||The intended sample size of 86 patients (N=43 per arm) had 80% power to detect a 5% difference in LVEF between the two arms after 1 year of treatment, assuming a standard deviation of change in LVEF of 7.46%, and 20% loss to follow-up. The study was stopped early by NHLBI when analysis of the interim data confirmed a required sample size of 86 that was not achievable within the required time frame within the participating or planned centres.||||0.89
72511291|NCT00506077|144553121|SUPERIORITY_OR_OTHER|||||||0.939||95.0||||The Benjamini \& Hochberg False Discovery Rate (FDR) approach at critical value 0.05 was used among 1 primary and 3 secondary cognition efficacy endpoints to control the false positive rate.|constrained longitudinal data analysis|The model factors were treatment, sequence, period, week (as categorical variable), site, treatment-by-week, sequence-by-week, and period-by-week.||||||0.939
72511292|NCT00506077|144553122|SUPERIORITY_OR_OTHER|||||||0.736||95.0||||P-Value Comments (limit 250 characters): The Benjamini \& Hochberg False Discovery Rate (FDR) approach at critical value 0.05 was used among 1 primary and 3 secondary cognition efficacy endpoints to control the false positive rate.|constrained Longitudinal Data Analysis|The model factors were treatment, sequence, period, week (as categorical variable), site, treatment-by-week, sequence-by-week, and period-by-week.||||||0.736
72567041|NCT03050918|144664958|SUPERIORITY|||||||0.05||||||We used the O'Brian-Fleming α-spending function, allowing for an α-level of significance of 0.005 and 0.048 for the interim and final analyses, respectively.|Wilcoxon (Mann-Whitney)|||||||0.05
72567042|NCT03050918|144664959|SUPERIORITY|||||||0.05||||||We used the O'Brian-Fleming α-spending function, allowing for an α-level of significance of 0.005 and 0.048 for the interim and final analyses, respectively.|Chi-squared|||||||0.05
72567043|NCT03050918|144664961|SUPERIORITY|||||||0.05||||||We used the O'Brian-Fleming α-spending function, allowing for an α-level of significance of 0.005 and 0.048 for the interim and final analyses, respectively.|Chi-squared|||||||0.05
72482563|NCT01794923|144492118|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.3||||0.067|TWO_SIDED|95.0|-0.02|0.63|||ANOVA|||12 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.63|-0.02|0.067
72482564|NCT01794923|144492118|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.0||||0.999|TWO_SIDED|95.0|-0.33|0.33|||ANOVA|||12 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.33|-0.33|0.999
72511293|NCT00506077|144553123|SUPERIORITY_OR_OTHER|||||||0.736||95.0||||The Benjamini \& Hochberg False Discovery Rate (FDR) approach at critical value 0.05 was used among 1 primary and 3 secondary cognition efficacy endpoints to control the false positive rate.|constrained Longitudinal Data Analysis|The model factors were treatment, sequence, period, week (as categorical variable), site, treatment-by-week, sequence-by-week, and period-by-week.||||||0.736
72567044|NCT00430950|144665015|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.5||||0.2648||95.0|-1.51|0.42|||ANCOVA|||"The ANCOVA model included treatment as main effect and baseline mean trough sitting dBP as covariate.~Significance level alpha = 5%. Power = 80%.~The following statistical superiority hypothesis was tested:~Superiority of OM/HCTZ combination therapy 40/25 mg over OM/HCTZ 20/25 mg"||0.42|-1.51|0.2648
72567045|NCT00430950|144665016|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.4||||0.4246||95.0|-1.26|0.53|||ANCOVA|||||0.53|-1.26|0.4246
72567046|NCT00430950|144665017|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.3||||0.7019||95.0|-1.84|1.24|||ANCOVA||refers to 8 week change; from week 8 to week 16|||1.24|-1.84|0.7019
72567047|NCT00430950|144665017|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.3||||0.7328||95.0|-1.71|1.21|||ANCOVA||refers to 4 week change; from week 8 to week 12|||1.21|-1.71|0.7328
72567048|NCT00430950|144665018|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.6||||0.0016||95.0|-2.58|-0.6|||ANCOVA||24 hour Ambulatory Blood Pressure Monitoring (ABPM) diastolic blood pressure (dBP)|||-0.60|-2.58|0.0016
72567049|NCT00430950|144665018|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.6||||0.0031||95.0|-2.61|-0.53|||ANCOVA||daytime Ambulatory Blood Pressure Monitoring (ABPM) diastolic blood pressure (dBP)|||-0.53|-2.61|0.0031
72567050|NCT00430950|144665018|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.5||||0.0073||95.0|-2.58|-0.4|||ANCOVA||night-time Ambulatory Blood Pressure Monitoring (ABPM) diastolic blood pressure (dBP)|||-0.40|-2.58|0.0073
72482565|NCT01794923|144492118|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.3||||0.088|TWO_SIDED|95.0|-0.05|0.66|||ANOVA|||12 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.66|-0.05|0.088
72482566|NCT01794923|144492118|SUPERIORITY_OR_OTHER_LEGACY|||||||0.195|TWO_SIDED||||||ANOVA|||24 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||||0.195
72482567|NCT01794923|144492118|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.3||||0.175|TWO_SIDED|95.0|-0.12|0.67|||ANOVA|||24 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.67|-0.12|0.175
72482568|NCT01794923|144492118|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.1||||0.61|TWO_SIDED|95.0|-0.5|0.3|||ANOVA|||24 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.30|-0.50|0.610
72482569|NCT01794923|144492118|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.4||||0.083|TWO_SIDED|95.0|-0.05|0.81|||ANOVA|||24 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.81|-0.05|0.083
72511294|NCT00506077|144553124|SUPERIORITY_OR_OTHER|||||||0.736||95.0||||The Benjamini \& Hochberg False Discovery Rate (FDR) approach at critical value 0.05 was used among 1 primary and 3 secondary cognition efficacy endpoints to control the false positive rate.|constrained Logitudinal Data Analysis|The model factors were treatment, sequence, period, week (as categorical variable), site, treatment-by-week, sequence-by-week, and period-by-week.||||||0.736
72511295|NCT00818324|144553129|SUPERIORITY_OR_OTHER||||||<|0.001||||||The p value represents the comparison between baseline data and data at Week 2|t-test, 2 sided|||||||<0.001
72511296|NCT00818324|144553129|SUPERIORITY_OR_OTHER||||||<|0.001||||||The p value represents the comparison between baseline data and data at Week 4.|t-test, 2 sided|||||||<0.001
72511297|NCT00818324|144553129|SUPERIORITY_OR_OTHER||||||<|0.001||||||The p value represents the comparison between baseline data and data at Week 28.|t-test, 2 sided|||||||<0.001
72511298|NCT00818324|144553129|SUPERIORITY_OR_OTHER||||||<|0.001||||||The p value represents the comparison between baseline data and data at Week 52.|t-test, 2 sided|||||||<0.001
72511299|NCT00818324|144553130|SUPERIORITY_OR_OTHER||||||<|0.001||||||The p value represents the comparison between baseline data and data at Week 2.|t-test, 2 sided|||||||<0.001
72511300|NCT00818324|144553130|SUPERIORITY_OR_OTHER||||||<|0.001||||||The p value represents the comparison between baseline data and data at Week 4.|t-test, 2 sided|||||||<0.001
72567051|NCT00430950|144665018|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.3||||0.0021||95.0|-3.71|-0.82|||ANCOVA||24 hour Ambulatory Blood Pressure Monitoring (ABPM) systolic blood pressure (sBP)|||-0.82|-3.71|0.0021
72482570|NCT01794923|144492118|SUPERIORITY_OR_OTHER_LEGACY|||||||0.884|TWO_SIDED||||||ANOVA|||30 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||||0.884
72482571|NCT01794923|144492118|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.0||||0.833|TWO_SIDED|95.0|-0.43|0.35|||ANOVA|||30 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.35|-0.43|0.833
72511301|NCT00818324|144553130|SUPERIORITY_OR_OTHER||||||<|0.001||||||The p value represents the comparison between baseline data and data at Week 28.|t-test, 2 sided|||||||<0.001
72511302|NCT00818324|144553130|SUPERIORITY_OR_OTHER||||||<|0.001||||||The p value represents the comparison between baseline data and data at Week 52.|t-test, 2 sided|||||||<0.001
72511303|NCT02868216|144553131|OTHER||Mean Difference (Final Values)|2.3|STANDARD_DEVIATION|0.84||0.05|TWO_SIDED|95.0|0.63|3.98|||ANOVA|||||3.98|0.63|0.05
72482572|NCT01794923|144492118|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.1||||0.62|TWO_SIDED|95.0|-0.49|0.29|||ANOVA|||30 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.29|-0.49|0.620
72482573|NCT01794923|144492118|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.1||||0.788|TWO_SIDED|95.0|-0.36|0.48|||ANOVA|||30 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.48|-0.36|0.788
72511304|NCT04891770|144553133|OTHER||percentage difference|2.5|||||TWO_SIDED|95.0|-2.3|7.3|||||For Cohort 2A versus Cohort 2B, the percentage difference and the corresponding 95% confidence interval was calculated using the stratum-adjusted Mantel-Haenszel method, stratified by HBsAg group (\> 3 and ≤ 3 log10 IU/mL).|||7.3|-2.3|
72511305|NCT04026412|144553138|SUPERIORITY||Hazard Ratio (HR)|0.95||||0.646|TWO_SIDED|96.0|0.77|1.19|||Cox proportional hazards model|||||1.19|0.77|0.6460
72511306|NCT04026412|144553139|SUPERIORITY||Hazard Ratio (HR)|1.1|||||TWO_SIDED|95.0|0.87|1.41||||||||1.41|0.87|
72511307|NCT04026412|144553139|SUPERIORITY||Hazard Ratio (HR)|0.96|||||TWO_SIDED|95.0|0.75|1.22||||||||1.22|0.75|
72511308|NCT04026412|144553139|SUPERIORITY||Hazard Ratio, log|1.16|||||TWO_SIDED|95.0|0.91|1.48||||||||1.48|0.91|
72511309|NCT04026412|144553140|SUPERIORITY||Hazard Ratio (HR)|0.85|||||TWO_SIDED|95.0|0.69|1.05||||||||1.05|0.69|
72511310|NCT04026412|144553140|SUPERIORITY||Hazard Ratio (HR)|1.15|||||TWO_SIDED|95.0|0.93|1.42||||||||1.42|0.93|
72511311|NCT04026412|144553141|SUPERIORITY||Difference in ORR|3.2|||||TWO_SIDED|95.0|-4.1|10.6||||||||10.6|-4.1|
72511312|NCT04026412|144553141|SUPERIORITY||Difference in ORR|7.8|||||TWO_SIDED|95.0|0.7|14.8||||||||14.8|0.7|
72511313|NCT04026412|144553141|SUPERIORITY||Difference in ORR|-4.7|||||TWO_SIDED|95.0|-11.8|2.5||||||||2.5|-11.8|
72511314|NCT04026412|144553144|SUPERIORITY||Hazard Ratio (HR)|1.0|||||TWO_SIDED|95.0|0.82|1.23||||||||1.23|0.82|
72511315|NCT04026412|144553144|SUPERIORITY||Hazard Ratio (HR)|0.86|||||TWO_SIDED|95.0|0.7|1.05||||||||1.05|0.70|
72511316|NCT04026412|144553144|SUPERIORITY||Hazard Ratio (HR)|1.17|||||TWO_SIDED|95.0|0.95|1.44||||||||1.44|0.95|
72511317|NCT04026412|144553145|SUPERIORITY||Difference in ORR|3.5|||||TWO_SIDED|95.0|-4.1|11.1||||||||11.1|-4.1|
72511318|NCT04026412|144553145|SUPERIORITY||Difference in ORR|5.4|||||TWO_SIDED|95.0|-2.0|12.9||||||||12.9|-2.0|
72511319|NCT04026412|144553145|SUPERIORITY||Difference in ORR|-1.9|||||TWO_SIDED|95.0|-9.5|5.6||||||||5.6|-9.5|
72511320|NCT04026412|144553148|SUPERIORITY||Hazard Ratio (HR)|0.97|||||TWO_SIDED|95.0|0.76|1.23||||||||1.23|0.76|
72511321|NCT04026412|144553148|SUPERIORITY||Hazard Ratio (HR)|0.83|||||TWO_SIDED|95.0|0.65|1.06||||||||1.06|0.65|
72511322|NCT04026412|144553148|SUPERIORITY||Hazard Ratio (HR)|1.16|||||TWO_SIDED|95.0|0.91|1.49||||||||1.49|0.91|
72511323|NCT01318083|144553165|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.936|||||TWO_SIDED|95.0|-1.097|-0.775||||||||-0.775|-1.097|
72511324|NCT01318083|144553165|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.998|||||TWO_SIDED|95.0|-1.16|-0.837||||||||-0.837|-1.160|
72511325|NCT01318083|144553166|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.196|||||TWO_SIDED|95.0|-0.261|-0.131||||||||-0.131|-0.261|
72511326|NCT01318083|144553166|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.213|||||TWO_SIDED|95.0|-0.273|-0.154||||||||-0.154|-0.273|
72511327|NCT01318083|144553167|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.41|||||TWO_SIDED|95.0|-0.507|-0.312||||||||-0.312|-0.507|
72482574|NCT01794923|144492118|SUPERIORITY_OR_OTHER_LEGACY|||||||0.755|TWO_SIDED||||||ANOVA|||36 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||||0.755
72482575|NCT01794923|144492118|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.1||||0.787|TWO_SIDED|95.0|-0.45|0.34|||ANOVA|||36 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.34|-0.45|0.787
72482576|NCT01794923|144492118|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.2||||0.455|TWO_SIDED|95.0|-0.56|0.25|||ANOVA|||36 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.25|-0.56|0.455
72482577|NCT01794923|144492118|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.1||||0.654|TWO_SIDED|95.0|-0.33|0.53|||ANOVA|||36 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.53|-0.33|0.654
72482578|NCT01794923|144492118|SUPERIORITY_OR_OTHER_LEGACY|||||||0.37|TWO_SIDED||||||ANOVA|||48 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||||0.370
72482579|NCT01794923|144492118|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.1||||0.472|TWO_SIDED|95.0|-0.51|0.24|||ANOVA|||48 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.24|-0.51|0.472
72482580|NCT01794923|144492118|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.2||||0.427|TWO_SIDED|95.0|-0.23|0.53|||ANOVA|||48 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.53|-0.23|0.427
72482581|NCT01794923|144492118|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.3||||0.159|TWO_SIDED|95.0|-0.69|0.11|||ANOVA|||48 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.11|-0.69|0.159
72511328|NCT01318083|144553167|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.453|||||TWO_SIDED|95.0|-0.547|-0.358||||||||-0.358|-0.547|
72567052|NCT00430950|144665018|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.3||||0.0031||95.0|-3.76|-0.76|||ANCOVA||daytime Ambulatory Blood Pressure Monitoring (ABPM) systolic blood pressure (sBP)|||-0.76|-3.76|0.0031
72482582|NCT01794923|144492118|SUPERIORITY_OR_OTHER_LEGACY|||||||0.48|TWO_SIDED||||||ANOVA|||54 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||||0.480
72482583|NCT01794923|144492118|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.2||||0.238|TWO_SIDED|95.0|-0.59|0.15|||ANOVA|||54 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.15|-0.59|0.238
72482584|NCT01794923|144492118|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.0||||0.794|TWO_SIDED|95.0|-0.42|0.32|||ANOVA|||54 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.32|-0.42|0.794
72511329|NCT01318083|144553168|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.695|||||TWO_SIDED|95.0|-0.834|-0.556||||||||-0.556|-0.834|
72567053|NCT00430950|144665018|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.0||||0.0104||95.0|-3.61|-0.48|||ANCOVA||night-time Ambulatory Blood Pressure Monitoring (ABPM) systolic blood pressure (sBP)|||-0.48|-3.61|0.0104
72567054|NCT00430950|144665019|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.09||||||95.0|0.85|1.4|||Regression, Logistic|||||1.40|0.85|
72567055|NCT03545191|144665037|OTHER||LS mean difference to placebo|-12.2|||<|0.0001|TWO_SIDED|95.0|-17.435|-6.961||Mixed effects model for repeated measures: change from baseline in WASO = baseline WASO + age group (\< 65; ≥ 65 years) + treatment + visit + treatment × visit + baseline × visit.|Mixed Models Analysis|||Between-treatment analysis for change from baseline in WASO (min) to Month 1 (Daridorexant 25 mg vs placebo).||-6.961|-17.435|<0.0001
72567056|NCT03545191|144665037|OTHER||LS mean difference to placebo|-22.78|||<|0.0001|TWO_SIDED|95.0|-27.996|-17.567||Mixed effects model for repeated measures: change from baseline in WASO = baseline WASO + age group (\< 65; ≥ 65 years) + treatment + visit + treatment × visit + baseline × visit.|Mixed Models Analysis|||Between-treatment analysis for change from baseline in WASO (min) to Month 1 (Daridorexant 50 mg vs placebo).||-17.567|-27.996|<0.0001
72402170|NCT04452331|144311574|SUPERIORITY|||||||0.74|||||||Regression, negative binomial|||||||0.74
72482585|NCT01794923|144492118|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.2||||0.395|TWO_SIDED|95.0|-0.57|0.23|||ANOVA|||54 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.23|-0.57|0.395
72482586|NCT01794923|144492118|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4|TWO_SIDED||||||ANOVA|||60 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||||0.400
72482587|NCT01794923|144492118|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.2||||0.176|TWO_SIDED|95.0|-0.61|0.11|||ANOVA|||60 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.11|-0.61|0.176
72482588|NCT01794923|144492118|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.1||||0.573|TWO_SIDED|95.0|-0.47|0.26|||ANOVA|||60 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.26|-0.47|0.573
72482589|NCT01794923|144492118|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.1||||0.466|TWO_SIDED|95.0|-0.53|0.24|||ANOVA|||60 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.24|-0.53|0.466
72511330|NCT01318083|144553168|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.77|||||TWO_SIDED|95.0|-0.911|-0.629||||||||-0.629|-0.911|
72511331|NCT01318083|144553169|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.71|||||TWO_SIDED|95.0|-24.6|-10.83||||||||-10.83|-24.60|
72511332|NCT01318083|144553169|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.59|||||TWO_SIDED|95.0|-24.93|-10.25||||||||-10.25|-24.93|
72511333|NCT01318083|144553170|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-23.17|||||TWO_SIDED|95.0|-30.33|-16.02||||||||-16.02|-30.33|
72511334|NCT01318083|144553170|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-24.88|||||TWO_SIDED|95.0|-32.33|-17.43||||||||-17.43|-32.33|
72482590|NCT01794923|144492118|SUPERIORITY_OR_OTHER_LEGACY|||||||0.092|TWO_SIDED||||||ANOVA|||72 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||||0.092
72482591|NCT01794923|144492118|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.3||||0.086|TWO_SIDED|95.0|-0.67|0.04|||ANOVA|||72 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.04|-0.67|0.086
72511335|NCT01318083|144553171|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-27.62|||||TWO_SIDED|95.0|-35.32|-19.91||||||||-19.91|-35.32|
72511336|NCT01318083|144553171|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-22.72|||||TWO_SIDED|95.0|-30.76|-14.69||||||||-14.69|-30.76|
72511337|NCT01318083|144553172|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-28.37|||||TWO_SIDED|95.0|-37.14|-19.59||||||||-19.59|-37.14|
72511338|NCT01318083|144553172|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-21.93|||||TWO_SIDED|95.0|-30.33|-13.54||||||||-13.54|-30.33|
72511339|NCT01318083|144553173|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-23.41|||||TWO_SIDED|95.0|-36.58|-10.23||||||||-10.23|-36.58|
72511340|NCT01318083|144553173|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.18|||||TWO_SIDED|95.0|-33.4|-4.95||||||||-4.95|-33.40|
72511341|NCT02094586|144553174|EQUIVALENCE|The GMT of each lot was required to be within ±50% of each other lot with 95% confidence. Specifically, the 95% CI around each pairwise ratio of GMTs was required to be within \[0.67, 1.5\].|Geometric Mean Ratio|0.92|||||TWO_SIDED|95.0|0.78|1.08||||||Lot A vs. Lot B||1.08|0.78|
72511342|NCT02094586|144553179|EQUIVALENCE|The GMT of each lot was required to be within ±50% of each other lot with 95% confidence. Specifically, the 95% CI around each pairwise ratio of GMTs was required to be within \[0.67, 1.5\].|Geometric Mean Ratio|1.02|||||TWO_SIDED|95.0|0.87|1.2||||||Lot B vs Lot C||1.20|0.87|
72482592|NCT01794923|144492118|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.1||||0.616|TWO_SIDED|95.0|-0.27|0.45|||ANOVA|||72 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.45|-0.27|0.616
72511343|NCT02094586|144553180|EQUIVALENCE|The GMT of each lot was required to be within ±50% of each other lot with 95% confidence. Specifically, the 95% CI around each pairwise ratio of GMTs was required to be within \[0.67, 1.5\].|Geometric Mean Ratio|0.94|||||TWO_SIDED|95.0|0.8|1.1||||||Lot A vs. Lot C||1.10|0.80|
72482593|NCT01794923|144492118|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.4||||0.04|TWO_SIDED|95.0|-0.79|-0.02|||ANOVA|||72 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||-0.02|-0.79|0.040
72511344|NCT02761993|144553181|SUPERIORITY|||||||0.341||||||Since there were two (2) primary hypotheses, Bonferroni corrections were used to control for multiplicity, with p \< 0.025 considered significant.|Generalized Estimating Equation|Generalized estimating equations (GEE) method with a linear link and exchangeable covariance matrix (with subject correlation structure)||||||0.341
72511345|NCT02761993|144553181|SUPERIORITY|||||||0.774||||||Since there were two (2) primary hypotheses, Bonferroni corrections were used to control for multiplicity, with p \< 0.025 considered significant.|Generalized Estimating Equations|Generalized estimating equations (GEE) method with a linear link and exchangeable covariance matrix (with subject correlation structure)||||||0.774
72511346|NCT02761993|144553182|SUPERIORITY|||||||0.501||||||Since there were two (2) primary hypotheses, Bonferroni corrections were used to control for multiplicity, with p \< 0.025 considered significant.|Generalized Estimating Equations|Generalized estimating equations (GEE) method with a linear link and exchangeable covariance matrix (with subject correlation structure)||||||0.501
72511347|NCT02761993|144553182|SUPERIORITY|||||||0.486||||||Since there were two (2) primary hypotheses, Bonferroni corrections were used to control for multiplicity, with p \< 0.025 considered significant.|Generalized Estimating Equations|Generalized estimating equations (GEE) method with a linear link and exchangeable covariance matrix (with subject correlation structure)||||||0.486
72511348|NCT02761993|144553183|SUPERIORITY|||||||0.816|||||||ANCOVA|||||||0.816
72511349|NCT02761993|144553183|SUPERIORITY|||||||0.706|||||||ANCOVA|||||||0.706
72511350|NCT01842620|144553184|EQUIVALENCE|Geometric means ratio for AUC (0-t) of test drug (Oxemet) to be entirely fallen within range of 0.80 to 1.25 of that of reference drug (Glafornil).|(Ratio of AUC0-36)*100|100.0|||||TWO_SIDED|90.0|92.62|107.98|||||Ratio of AUC0-36= (AUC0-36 of Test)/ AUC 0-36 Reference)|Overall period||107.98|92.62|
72511351|NCT01842620|144553185|EQUIVALENCE|Geometric means ratio for AUC(0-inf) of test drug (Oxemet) to be entirely fallen within range of 0.80 to 1.25 of that of reference drug (Glafornil).|(Ratio of AUC0-inf)*100|99.02|||||TWO_SIDED|90.0|92.26|106.27|||||Ratio of AUC0-inf= (AUC0-inf of Test) / (AUC 0-inf of Reference)|For overall period||106.27|92.26|
72511352|NCT01842620|144553186|EQUIVALENCE|Geometric means ratio for Cmax of test drug (Oxemet) to be entirely fallen within range of 0.80 to 1.25 of that of reference drug (Glafornil).|(Ratio of Cmax)*100|98.34|||||TWO_SIDED|90.0|88.54|109.22|||||Ratio of Cmax= (Cmax of Test) / (Cmax of Reference)|Overall period||109.22|88.54|
72511353|NCT00256867|144553190|SUPERIORITY_OR_OTHER||Ratio Expressed as percent difference|-37.186|||<|0.0001|TWO_SIDED|95.0|-41.219|-32.879|||ANCOVA||Estimation parameter was Ratio to RSG Group expressed as percent difference from RSG group. Based on ANCOVA : Log(value) - log(baseline)= log(baseline) + sex + country + Treatment + Prior Sulfonylurea use|||-32.879|-41.219|<0.0001
72511354|NCT00256867|144553191|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.82|||<|0.0001|TWO_SIDED|95.0|-1.09|-0.55|||ANCOVA||Change = Baseline + sex + country + Treatment + Prior Sulfonylurea use|||-0.55|-1.09|<0.0001
72511355|NCT00256867|144553195|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|36.32|||<|0.0001||95.0|16.52|79.85|||ANCOVA||Odds (logistic regression:log odds=Baseline + sex + Treatment + Prior Sulfonylurea use) of having an LDL-c \< 100 mg/dL at Week 6 on All FDC RSG/SIMV groups compared to All RSG monotherapy groups|||79.85|16.52|<.0001
72482594|NCT01794923|144492119|SUPERIORITY_OR_OTHER_LEGACY|||||||0.751|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Analysis was performed using Cochran-Mantel-Haenszel (CMH) test with modified ridit scores, controlling for baseline categorical PSR (BLPSR) and sex.||||0.751
72567057|NCT03545191|144665038|OTHER||LS mean difference to placebo|-11.86|||<|0.0001|TWO_SIDED|95.0|-17.494|-6.23||Mixed effects model for repeated measures: change from baseline in WASO = baseline WASO + age group (\< 65; ≥ 65 years) + treatment + visit + treatment × visit + baseline × visit.|Mixed Models Analysis|||Between-treatment analysis for change from baseline in WASO (min) to Month 3 (Daridorexant 25 mg vs placebo).||-6.23|-17.494|<0.0001
72567058|NCT03545191|144665038|OTHER||LS mean difference to placebo|-18.3|||<|0.0001|TWO_SIDED|95.0|-23.945|-12.661||Mixed effects model for repeated measures: change from baseline in WASO = baseline WASO + age group (\< 65; ≥ 65 years) + treatment + visit + treatment × visit + baseline × visit.|Mixed Models Analysis|||Between-treatment analysis for change from baseline in WASO (min) to Month 3 (Daridorexant 50 mg vs placebo).||-12.661|-23.945|<0.0001
72567059|NCT03545191|144665039|OTHER||LS mean difference to placebo|-8.32||||0.0005|TWO_SIDED|95.0|-13.014|-3.629||Mixed effects model for repeated measures: change from baseline in LPS = baseline LPS + age group (\< 65; ≥ 65 years) + treatment + visit + treatment × visit + baseline × visit.|Mixed Models Analysis|||Between-treatment analysis for change from baseline in LPS (min) to Month 1 (Daridorexant 25 mg vs placebo).||-3.629|-13.014|0.0005
72567060|NCT03545191|144665039|OTHER||LS mean difference to placebo|-11.35|||<|0.0001|TWO_SIDED|95.0|-16.022|-6.687||Mixed effects model for repeated measures: change from baseline in LPS = baseline LPS + age group (\< 65; ≥ 65 years) + treatment + visit + treatment × visit + baseline × visit.|Mixed Models Analysis|||Between-treatment analysis for change from baseline in LPS (min) to Month 1 (Daridorexant 50 mg vs placebo).||-6.687|-16.022|<0.0001
72402171|NCT04452331|144311575|SUPERIORITY|||||||0.03|||||||Regression, Linear|||||||0.03
72482595|NCT01794923|144492119|SUPERIORITY_OR_OTHER_LEGACY||Weighted Gamma Statistic|0.0||||0.696|TWO_SIDED|95.0|-0.28|0.2|||Cochran-Mantel-Haenszel|||Analysis was performed using Cochran-Mantel-Haenszel (CMH) test with modified ridit scores, controlling for baseline categorical PSR (BLPSR) and sex.||0.20|-0.28|0.696
72482596|NCT01794923|144492119|SUPERIORITY_OR_OTHER_LEGACY||Weighted Gamma Statistic|0.0||||0.76|TWO_SIDED|95.0|-0.21|0.29|||Cochran-Mantel-Haenszel|||Analysis was performed using Cochran-Mantel-Haenszel (CMH) test with modified ridit scores, controlling for baseline categorical PSR (BLPSR) and sex.||0.29|-0.21|0.760
72482597|NCT01794923|144492119|SUPERIORITY_OR_OTHER_LEGACY||Weighted Gamma Statistic|-0.1||||0.463|TWO_SIDED|95.0|-0.36|0.16|||Cochran-Mantel-Haenszel|||Analysis was performed using Cochran-Mantel-Haenszel (CMH) test with modified ridit scores, controlling for baseline categorical PSR (BLPSR) and sex.||0.16|-0.36|0.463
72482598|NCT03318809|144492133|OTHER|Analysis of Variance|Ratio (Group 1/Group 2)|1.24|||||TWO_SIDED|90.0|0.73|2.1|||||The ratio and confidence interval (CI) are based on natural log scale data converted back to the original scale.|||2.10|0.73|
72567061|NCT03545191|144665040|OTHER||LS mean difference to placebo|-7.59||||0.0015|TWO_SIDED|95.0|-12.265|-2.923||Mixed effects model for repeated measures: change from baseline in LPS = baseline LPS + age group (\< 65; ≥ 65 years) + treatment + visit + treatment × visit + baseline × visit.|Mixed Models Analysis|||Between-treatment analysis for change from baseline in LPS (min) to Month 3 (Daridorexant 25 mg vs placebo).||-2.923|-12.265|0.0015
72567062|NCT03545191|144665040|OTHER||LS mean difference to placebo|-11.67|||<|0.0001|TWO_SIDED|95.0|-16.348|-6.994||Mixed effects model for repeated measures: change from baseline in LPS = baseline LPS + age group (\< 65; ≥ 65 years) + treatment + visit + treatment × visit + baseline × visit.|Mixed Models Analysis|||Between-treatment analysis for change from baseline in LPS (min) to Month 3 (Daridorexant 50 mg vs placebo).||-6.994|-16.348|<0.0001
72482599|NCT03318809|144492134|OTHER|Analysis of Variance|Ratio (Group 1/Group 2)|1.41|||||TWO_SIDED|90.0|0.88|2.27|||||The ratio and CI are based on natural log scale data converted back to the original scale.|||2.27|0.88|
72482600|NCT03318809|144492137|OTHER|Analysis of Variance|Ratio (Group 1/Group 2)|1.24|||||TWO_SIDED|90.0|0.73|2.1|||||The ratio and CI are based on natural log scale data converted back to the original scale.|||2.10|0.73|
72402172|NCT04452331|144311575|SUPERIORITY|||||||0.06|||||||Regression, Linear|||||||0.06
72482601|NCT02340091|144492143|SUPERIORITY||Subjects % with difference in VAS ≥ 10mm|0.9194|||||TWO_SIDED|95.0|0.8|0.97||||||||0.97|0.80|
72624024|NCT02231580|144778429|SUPERIORITY_OR_OTHER||GLS mean ratio|0.919|||=|0.3535|TWO_SIDED|90.0|0.789|1.069|||MMRM|||Right hand freq statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||1.069|0.789|=0.3535
72402173|NCT04452331|144311576|SUPERIORITY||||||<|0.001|||||||Regression, negative binomial|||||||<0.001
72482602|NCT00292461|144492155|SUPERIORITY_OR_OTHER|||||||0.24|||||||ANOVA|||||||0.240
72482603|NCT00292461|144492156|SUPERIORITY_OR_OTHER|||||||0.46||95.0|||||Cochran-Mantel-Haenszel|||||||0.460
72482604|NCT00292461|144492157|SUPERIORITY_OR_OTHER|||||||0.079||95.0|||||Cochran-Mantel-Haenszel|||||||0.079
72482605|NCT00292461|144492158|SUPERIORITY_OR_OTHER|||||||0.86||95.0|||||Cochran-Mantel-Haenszel|||||||0.860
72482606|NCT05640648|144492162|OTHER||Incidence rate ratio|1.84|||<|0.001|TWO_SIDED|95.0|1.62|2.09|||Mixed Models Analysis|Mixed-effects Poisson model adjusting for time and group level (paired health centres, based on randomization) cluster||||2.09|1.62|<0.001
72482607|NCT05640648|144492163|OTHER||Incidence Rate Ratio|7.46||||0.002|TWO_SIDED|95.0|2.06|26.95|||Mixed Models Analysis|Mixed-effects Poisson model adjusting for time and group level (paired health centres, based on randomization) cluster||||26.95|2.06|0.002
72482608|NCT05640648|144492164|OTHER||Incidence Rate Ratio|1.25||||0.5|TWO_SIDED|95.0|0.65|2.42|||Mixed Models Analysis|Mixed effects poisson model adjusting for time and group (paired healthcentres, based on randomization)||||2.42|0.65|0.50
72482609|NCT05640648|144492167|OTHER||Incidence Rate Ratio|4.75|||<|0.001|TWO_SIDED|95.0|2.07|10.91|||Mixed Models Analysis|Mixed-effects Poisson model adjusting for time and group level (paired health centres, based on randomization) cluster||||10.91|2.07|<0.001
72482610|NCT04484259|144492168|NON_INFERIORITY|non-inferiority margin 45 PRU|Mean Difference (Final Values)|7.0|||||TWO_SIDED|95.0|-23.0|38.0||||||The primary end point was non-inferiority of Ticagrelor 60 mg monotherapy vs. aspirin plus Ticagrelor 60 mg||38|-23|
72482611|NCT04908189|144492173|SUPERIORITY||Adjusted Mean Difference|-0.4743|STANDARD_ERROR_OF_MEAN|0.08735|<|0.0001|TWO_SIDED|95.0|-0.6455|-0.3031|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|||-0.3031|-0.6455|<0.0001
72482612|NCT04908189|144492174|SUPERIORITY||Adjusted mean difference|-0.1126|STANDARD_ERROR_OF_MEAN|0.03511||0.0013|TWO_SIDED|95.0|-0.1814|-0.0438|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|||-0.0438|-0.1814|0.0013
72482613|NCT04908189|144492176|SUPERIORITY||Adjusted mean difference|2.042|STANDARD_ERROR_OF_MEAN|0.5421||0.0002|TWO_SIDED|95.0|0.98|3.105|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|||3.105|0.980|0.0002
72482614|NCT04908189|144492179|SUPERIORITY||Adjusted mean difference|0.8|STANDARD_ERROR_OF_MEAN|0.61||0.2017|TWO_SIDED|95.0|-0.4|2.0|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|||2.0|-0.4|0.2017
72482615|NCT04908189|144492183|SUPERIORITY||Adjusted mean difference|0.0643|STANDARD_ERROR_OF_MEAN|0.02831||0.0231|TWO_SIDED|95.0|0.0088|0.1198|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Week 2||0.1198|0.0088|0.0231
72482616|NCT04908189|144492183|SUPERIORITY||Adjusted mean difference|0.0085|STANDARD_ERROR_OF_MEAN|0.03126||0.7865|TWO_SIDED|95.0|-0.0528|0.0697|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Week 4||0.0697|-0.0528|0.7865
72482617|NCT04908189|144492183|SUPERIORITY||Adjusted mean difference|-0.0515|STANDARD_ERROR_OF_MEAN|0.03386||0.128|TWO_SIDED|95.0|-0.1179|0.0148|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Week 8||0.0148|-0.1179|0.1280
72482618|NCT04908189|144492183|SUPERIORITY||Adjusted mean differnce|-0.0541|STANDARD_ERROR_OF_MEAN|0.0346||0.118|TWO_SIDED|95.0|-0.1219|0.0137|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Week 12||0.0137|-0.1219|0.1180
72482619|NCT04908189|144492183|SUPERIORITY||Adjusted mean difference|-0.1126|STANDARD_ERROR_OF_MEAN|0.03511||0.0013|TWO_SIDED|95.0|-0.1814|-0.0438|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Week 16||-0.0438|-0.1814|0.0013
72402174|NCT04452331|144311576|SUPERIORITY|||||||0.03|||||||Regression, negative binomial|||||||0.03
72482620|NCT04908189|144492188|SUPERIORITY||Adjusted mean difference|0.692|STANDARD_ERROR_OF_MEAN|0.4384||0.1147|TWO_SIDED|95.0|-0.168|1.551|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Week 4||1.551|-0.168|0.1147
72482621|NCT04908189|144492188|SUPERIORITY||Adjusted mean difference|1.999|STANDARD_ERROR_OF_MEAN|0.5147||0.0001|TWO_SIDED|95.0|0.991|3.008|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Week 12||3.008|0.991|0.0001
72482622|NCT04908189|144492188|SUPERIORITY||Adjusted mean difference|2.042|STANDARD_ERROR_OF_MEAN|0.5421||0.0002|TWO_SIDED|95.0|0.98|3.105|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Week 16||3.105|0.980|0.0002
72511356|NCT00256867|144553196|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.05|||<|0.0001|TWO_SIDED|95.0|2.32|7.07|||ANCOVA||Odds (logistic regression: log odds=Baseline + sex + Treatment + Prior SU use) of having an HbA1c \< 7% or reduction of HbA1c \>= 0.7% at Week 16 on All FDC group compared to Simv group.|||7.07|2.32|<0.0001
72511357|NCT00256867|144553197|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.93|||<|0.0001|TWO_SIDED|95.0|2.21|7.0|||ANCOVA||Odds (logistic regression:log odds=Baseline + sex + Treatment + Prior SU use) of having an FPG \< 7.0 mmol/L or reduction of FPG \>= 1.67 mmol/L at Week 16 on All FDC group compared to Simv group.|||7|2.21|<0.0001
72511358|NCT02993224|144553203|SUPERIORITY||Difference of proportion|0.83|||<|0.0001|TWO_SIDED|95.0|0.75|0.89|||McNemar|||Preference for deferasirox DT vs deferasirox FCT||0.89|0.75|<.0001
72511359|NCT02993224|144553204|SUPERIORITY||Difference of proportion|0.78|||<|0.0001|TWO_SIDED|95.0|0.65|0.88|||McNemar|||Preference of deferasirox FCT vs deferasirox DT||0.88|0.65|<0.0001
72511360|NCT02993224|144553204|SUPERIORITY||Difference of proportion|0.83|||<|0.0001|TWO_SIDED|95.0|0.71|0.91|||McNemar|||Preference for deferasirox FCT vs previous iron chelation therapy||0.91|0.71|<0.0001
72511361|NCT02993224|144553205|SUPERIORITY||Difference of proportion|0.66|||<|0.0001|TWO_SIDED|95.0|0.51|0.77|||McNemar|||Deferasirox DT vs previous iron chelation therapy at Week 4||0.77|0.51|< 0.0001
72511362|NCT02993224|144553205|SUPERIORITY||Difference of proportion|0.59|||<|0.0001|TWO_SIDED|95.0|0.44|0.72|||McNemar|||Deferasirox DT vs previous iron chelation therapy at Week 24||0.72|0.44|< 0.0001
72511363|NCT02993224|144553207|SUPERIORITY||Least squares mean|-3.6|STANDARD_ERROR_OF_MEAN|2.3||0.1191|TWO_SIDED|95.0|-8.1|0.9|||ANCOVA|||Compliance of deferasirox DT vs deferasirox FCT||0.9|-8.1|0.1191
72511364|NCT00952289|144553225|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Fisher Exact|||The primary endpoint analyzed with a 2-sided alpha of 0.05.||||<0.0001
72511365|NCT00875017|144553236|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) Mean Difference|-65.75|||<|0.001||95.0|-96.01|-35.49|||Mixed Models Analysis|||Net phosphorus absorption was analysed using a mixed linear effect model with fixed effects for sequence group, period and treatment group. Subject within sequence effect was included as a random effect.||-35.49|-96.01|<0.001
72511366|NCT00875017|144553236|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-125.65|||<|0.001||95.0|-155.91|-95.39|||Mixed Models Analysis|||Net phosphorus absorption was analysed using a mixed linear effect model with fixed effects for sequence group, period and treatment group. Subject within sequence effect was included as a random effect.||-95.39|-155.91|<0.001
72511367|NCT00875017|144553236|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-59.9|||<|0.001||95.0|-89.87|-29.93|||Mixed Models Analysis|||Net phosphorus absorption was analysed using a mixed linear effect model with fixed effects for sequence group, period and treatment group. Subject within sequence effect was included as a random effect.||-29.93|-89.87|<0.001
72511368|NCT00875017|144553237|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|71.9|||<|0.001||95.0|40.03|103.77|||Mixed Models Analysis|||Phosphorus binding was analysed using a mixed linear effect model with fixed effects for sequence group, period and treatment group. Subject within sequence effect was included as a random effect.||103.77|40.03|<0.001
72511369|NCT00875017|144553238|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-20.67||||0.049||95.0|-41.22|-0.13|||Mixed Models Analysis|||Net calcium absorption was analysed using a mixed linear effect model with fixed effects for sequence group, period and treatment group. Subject within sequence effect was included as a random effect.||-0.13|-41.22|0.049
72567063|NCT03545191|144665041|OTHER||LS mean difference to placebo|12.62|||=|0.0013|TWO_SIDED|95.0|4.953|20.288||Mixed effects model for repeated measures: change from baseline in sTST = baseline sTST + age group (\< 65; ≥ 65 years) + treatment + visit + treatment × visit + baseline × visit.|Mixed Models Analysis|||Between-treatment analysis for change from baseline in sTST (min) to Month 1 (Daridorexant 25 mg vs placebo).||20.288|4.953|= 0.0013
72567064|NCT03545191|144665041|OTHER||LS mean difference to placebo|22.06|||<|0.0001|TWO_SIDED|95.0|14.405|29.708||Mixed effects model for repeated measures: change from baseline in sTST = baseline sTST + age group (\< 65; ≥ 65 years) + treatment + visit + treatment × visit + baseline × visit.|Mixed Models Analysis|||Between-treatment analysis for change from baseline in sTST (min) to Month 1 (Daridorexant 25 mg vs placebo).||29.708|14.405|< 0.0001
72567065|NCT03545191|144665042|OTHER||LS mean difference to placebo|9.93|||=|0.0334|TWO_SIDED|95.0|0.782|19.082||Mixed effects model for repeated measures: change from baseline in sTST = baseline sTST + age group (\< 65; ≥ 65 years) + treatment + visit + treatment × visit + baseline × visit.|Mixed Models Analysis|||Between-treatment analysis for change from baseline in sTST (min) to Month 3 (Daridorexant 25 mg vs placebo).||19.082|0.782|= 0.0334
72567066|NCT03545191|144665042|OTHER||LS mean difference to placebo|19.77|||<|1e-05|TWO_SIDED|95.0|10.623|28.918||Mixed effects model for repeated measures: change from baseline in sTST = baseline sTST + age group (\< 65; ≥ 65 years) + treatment + visit + treatment × visit + baseline × visit.|Mixed Models Analysis|||Between-treatment analysis for change from baseline in sTST (min) to Month 3 (Daridorexant 50 mg vs placebo).||28.918|10.623|< .00001
72402175|NCT04452331|144311577|SUPERIORITY||||||<|0.001|||||||Regression, poisson|||||||<0.001
72511370|NCT00875017|144553238|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-15.56||||0.133||95.0|-36.11|4.99|||Mixed Models Analysis|||Net calcium absorption was analysed using a mixed linear effect model with fixed effects for sequence group, period and treatment group. Subject within sequence effect was included as a random effect.||4.99|-36.11|0.133
72511371|NCT00875017|144553238|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|5.11||||0.612||95.0|-15.24|25.47|||Mixed Models Analysis|||Net calcium absorption was analysed using a mixed linear effect model with fixed effects for sequence group, period and treatment group. Subject within sequence effect was included as a random effect.||25.47|-15.24|0.612
72511372|NCT03342469|144553239|OTHER||||||>|0.05||||||Significance level \</= 0.05. This was chosen due to the small sample size. The p-value is not adjusted for multiple comparisons as this was a pilot study and a power analysis for sample size was not conducted.|repeated measures General Linear Model|||Difference in Delta Power in ADHD group with and without exposure to AFC. General linear model assessed the impact of treatment (AFC v. placebo) on each EEG frequency band, taking into account order of materials. Dependent variable = Treatment (EEG power during AFC, EEG power during placebo); independent variable = order (AFC/placebo, placebo/AFC) This is a pilot study, thus a power calculation was not done and it was not power to correct for multiple comparisons.||||>0.05
72567067|NCT03545191|144665043|OTHER||LS mean difference to placebo|-0.75|||=|0.0547|TWO_SIDED|95.0|-1.515|0.015||Mixed effects model for repeated measures: change from baseline in IDSIQ sleepiness domain score = baseline IDSIQ sleepiness domain score + age group (\< 65; ≥ 65 years) + treatment + visit + treatment × visit + baseline × visit.|Mixed Models Analysis|||Between-treatment analysis for change from baseline in IDSIQ sleepiness domain score to Month 1 (Daridorexant 25 mg vs placebo).||0.015|-1.515|= 0.0547
72567068|NCT03545191|144665043|OTHER||LS mean difference to placebo|-1.75|||<|1e-05|TWO_SIDED|95.0|-2.508|-0.983||Mixed effects model for repeated measures: change from baseline in IDSIQ sleepiness domain score = baseline IDSIQ sleepiness domain score + age group (\< 65; ≥ 65 years) + treatment + visit + treatment × visit + baseline × visit.|Mixed Models Analysis|||Between-treatment analysis for change from baseline in IDSIQ sleepiness domain score to Month 1 (Daridorexant 50 mg vs placebo).||-0.983|-2.508|< .00001
72624025|NCT02231580|144778430|SUPERIORITY_OR_OTHER||GLS mean ratio|2.163|||=|0.015|TWO_SIDED|90.0|1.295|3.614|||MMRM|||Left foot IOI variability statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||3.614|1.295|=0.015
72567069|NCT03545191|144665044|OTHER||LS mean difference to placebo|-0.99||||0.0534|TWO_SIDED|95.0|-1.99|0.014||Mixed effects model for repeated measures: change from baseline in IDSIQ sleepiness domain score = baseline IDSIQ sleepiness domain score + age group (\< 65; ≥ 65 years) + treatment + visit + treatment × visit + baseline × visit.|Mixed Models Analysis|||Between-treatment analysis for change from baseline in IDSIQ sleepiness domain score to Month 3 (Daridorexant 25 mg vs placebo).||0.014|-1.990|0.0534
72624026|NCT02231580|144778430|SUPERIORITY_OR_OTHER||GLS mean ratio|1.274|||=|0.5136|TWO_SIDED|90.0|0.688|2.361|||MMRM|||Right foot IOI variability statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||2.361|0.688|=0.5136
72624027|NCT02231580|144778430|SUPERIORITY_OR_OTHER||GLS mean ratio|1.56|||=|0.0218|TWO_SIDED|90.0|1.139|2.137|||MMRM|||Left foot IOI duration statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||2.137|1.139|=0.0218
72624028|NCT02231580|144778430|SUPERIORITY_OR_OTHER||GLS mean ratio|1.251|||=|0.372|TWO_SIDED|90.0|0.825|1.899|||MMRM|||Right foot IOI duration statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||1.899|0.825|=0.3720
72624029|NCT02231580|144778431|SUPERIORITY_OR_OTHER||GLS mean ratio|1.911|||=|0.915|TWO_SIDED|90.0|1.017|3.592|||MMRM|||Left foot TD variability statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||3.592|1.017|=0.915
72624030|NCT02231580|144778431|SUPERIORITY_OR_OTHER||GLS mean ratio|1.687|||=|0.2745|TWO_SIDED|90.0|0.762|3.737|||MMRM|||Right foot TD variability statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||3.737|0.762|=0.2745
72567070|NCT03545191|144665044|OTHER||LS mean difference to placebo|-1.9|||=|0.0002|TWO_SIDED|95.0|-2.905|-0.905|||Mixed Models Analysis|||Between-treatment analysis for change from baseline in IDSIQ sleepiness domain score to Month 3 (Daridorexant 50 mg vs placebo).||-0.905|-2.905|= 0.0002
72567071|NCT03545191|144665045|OTHER||LSGM ratio to placebo|0.79||||0.0003|TWO_SIDED|95.0|0.7|0.9||Mixed effects model for repeated measures: log(value/baseline) = log(baseline) + age group(\< 65; ≥ 65 years) + treatment + visit + treatment x visit + log(baseline) x visit.|Mixed Models Analysis|||Between-treatment analysis for change from baseline in log transformed LPS (min) to Month 1 (Daridorexant 25 mg vs placebo).||0.90|0.70|0.0003
72402176|NCT04452331|144311577|SUPERIORITY|||||||0.08|||||||Regression, poisson|||||||0.08
72482623|NCT04908189|144492192|SUPERIORITY||Adjusted mean difference|-0.284|STANDARD_ERROR_OF_MEAN|0.567||0.6159|TWO_SIDED|95.0|-1.396|0.827|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Week 4||0.827|-1.396|0.6159
72482624|NCT04908189|144492192|SUPERIORITY||Adjusted mean difference|0.829|STANDARD_ERROR_OF_MEAN|0.625||0.1847|TWO_SIDED|95.0|-0.396|2.054|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Week 12||2.054|-0.396|0.1847
72624031|NCT02231580|144778431|SUPERIORITY_OR_OTHER||GLS mean ratio|1.598|||=|0.1148|TWO_SIDED|90.0|0.98|2.608|||MMRM|||Left foot TD duration statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||2.608|0.980|=0.1148
72482625|NCT04908189|144492192|SUPERIORITY||Adjusted mean difference|1.145|STANDARD_ERROR_OF_MEAN|0.673||0.0888|TWO_SIDED|95.0|-0.174|2.464|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Week 16||2.464|-0.174|0.0888
72511373|NCT03342469|144553239|OTHER||||||>|0.05||||||Significance level \</= 0.05. This was chosen due to the small sample size. The p-value is not adjusted for multiple comparisons as this was a pilot study and a power analysis for sample size was not conducted.|repeated measures General Linear Model|||Difference in Theta Power in ADHD group with and without exposure to AFC. General linear model assessed the impact of treatment (AFC v. placebo) on each EEG frequency band, taking into account order of materials. Dependent variable = Treatment (EEG power during AFC, EEG power during placebo); independent variable = order (AFC/placebo, placebo/AFC) This is a pilot study, thus a power calculation was not done and it was not power to correct for multiple comparisons.||||>0.05
72542460|NCT00106028|144614679|SUPERIORITY_OR_OTHER||Mean Difference (Net)|14.029||||0.0793|TWO_SIDED|95.0|-1.667|29.726|||ANCOVA|LS means and p-value are from ANCOVA model adjusted by baseline and fixed effects for age group, treatment and pooled center for post-baseline.||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.||29.726|-1.667|0.0793
72624032|NCT02231580|144778431|SUPERIORITY_OR_OTHER||GLS mean ratio|1.454|||=|0.308|TWO_SIDED|90.0|0.789|2.679|||MMRM|||Right foot TD duration statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||2.679|0.789|=0.3080
72542461|NCT00106028|144614680|SUPERIORITY_OR_OTHER||Mean Difference (Net)|8.567|||<|0.0001||95.0|5.59|11.545|||ANCOVA|LS means and p-value are from ANCOVA model adjusted by baseline and with fixed effects for age group, treatment and pooled center for post-baseline.||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.||11.545|5.590|<0.0001
72542462|NCT00106028|144614681|SUPERIORITY_OR_OTHER||Mean Difference (Net)|6.315||||0.4575|TWO_SIDED|95.0|-10.477|23.107|||ANCOVA|LS means and p-value are from ANCOVA model adjusted by baseline and fixed effects for age group, treatment and pooled center for post-baseline.||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.||23.107|-10.477|0.4575
72542463|NCT00106028|144614682|SUPERIORITY_OR_OTHER||Mean Difference (Net)|37.594||||0.0172||95.0|6.801|68.386|||ANCOVA|LS means and p-value are from ANCOVA model adjusted by baseline and fixed effects for age group, treatment and pooled center for post-baseline.||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.||68.386|6.801|0.0172
72542464|NCT00106028|144614683|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.492||||0.9786|TWO_SIDED|95.0|-36.807|35.824|||ANCOVA|LS means and p-value are from ANCOVA model adjusted by baseline and fixed effects for age group, treatment and pooled center for post-baseline.||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.||35.824|-36.807|0.9786
72542465|NCT00106028|144614684|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-8.64||||0.5971|TWO_SIDED|95.0|-40.952|23.672|||ANCOVA|LS means and p-value are from ANCOVA model adjusted by baseline and fixed effects for age group, treatment and pooled center for post-baseline.||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.||23.672|-40.952|0.5971
72542466|NCT00106028|144614685|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.014||||0.4154||95.0|-1.442|3.47|||ANCOVA|LS means and p-value are from ANCOVA model adjusted by baseline and fixed effects for age group, treatment and pooled center for post-baseline.||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.||3.470|-1.442|0.4154
72542467|NCT00106028|144614686|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.884||||0.6404|TWO_SIDED|95.0|-2.855|4.623|||ANCOVA|LS means and p-value are from ANCOVA model adjusted by baseline and fixed effects for age group, treatment and pooled center for post-baseline.||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.||4.623|-2.855|0.6404
72511374|NCT03342469|144553239|OTHER||||||>|0.05||||||Significance level \</= 0.05. This was chosen due to the small sample size. The p-value is not adjusted for multiple comparisons as this was a pilot study and a power analysis for sample size was not conducted.|repeated measures General Linear Model|||Difference in Alpha Power in ADHD group with and without exposure to AFC. General linear model assessed the impact of treatment (AFC v. placebo) on each EEG frequency band, taking into account order of materials. Dependent variable = Treatment (EEG power during AFC, EEG power during placebo); independent variable = order (AFC/placebo, placebo/AFC) This is a pilot study, thus a power calculation was not done and it was not power to correct for multiple comparisons.||||>0.05
72624033|NCT02231580|144778432|SUPERIORITY_OR_OTHER||GLS mean ratio|2.272|||=|0.0079|TWO_SIDED|90.0|1.381|3.737|||MMRM|||Left foot IPI variability statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||3.737|1.381|=0.0079
72511375|NCT03342469|144553239|OTHER|||||||0.08||||||Significance level \</= 0.05. This was chosen due to the small sample size. The p-value is not adjusted for multiple comparisons as this was a pilot study and a power analysis for sample size was not conducted.|repeated measures General Linear Model|||Difference in Beta Power in ADHD group with and without exposure to AFC. General linear model assessed the impact of treatment (AFC v. placebo) on each EEG frequency band, taking into account order of materials. Dependent variable = Treatment (EEG power during AFC, EEG power during placebo); independent variable = order (AFC/placebo, placebo/AFC) This is a pilot study, thus a power calculation was not done and it was not power to correct for multiple comparisons.||||0.08
72511376|NCT03342469|144553239|OTHER|||||||0.05||||||Significance level \</= 0.05. This was chosen due to the small sample size. The p-value is not adjusted for multiple comparisons as this was a pilot study and a power analysis for sample size was not conducted.|repeated measures General Linear Model|F(1,14)= 4.55||Difference in Gamma Power in ADHD group with and without exposure to AFC. General linear model assessed the impact of treatment (AFC v. placebo) on each EEG frequency band, taking into account order of materials. Dependent variable = Treatment (EEG power during AFC, EEG power during placebo); independent variable = order (AFC/placebo, placebo/AFC) This is a pilot study, thus a power calculation was not done and it was not power to correct for multiple comparisons.||||0.05
72624034|NCT02231580|144778432|SUPERIORITY_OR_OTHER||GLS mean ratio|1.21|||=|0.0204|TWO_SIDED|90.0|0.686|2.133|||MMRM|||Right foot IPI variability statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||2.133|0.686|=0.0204
72511377|NCT03342469|144553239|OTHER||||||>|0.05||||||Significance level \</= 0.05. This was chosen due to the small sample size. The p-value is not adjusted for multiple comparisons as this was a pilot study and a power analysis for sample size was not conducted.|repeated measures General Linear Model|||Difference in Delta Power in control group with and without exposure to AFC. General linear model assessed the impact of treatment (AFC v. placebo) on each EEG frequency band, taking into account order of materials. Dependent variable = Treatment (EEG power during AFC, EEG power during placebo); independent variable = order (AFC/placebo, placebo/AFC) This is a pilot study, thus a power calculation was not done and it was not power to correct for multiple comparisons.||||>0.05
72511378|NCT03342469|144553239|OTHER||||||>|0.05||||||Significance level \</= 0.05. This was chosen due to the small sample size. The p-value is not adjusted for multiple comparisons as this was a pilot study and a power analysis for sample size was not conducted.|repeated measures General Linear Model|||Difference in Theta Power in control group with and without exposure to AFC. General linear model assessed the impact of treatment (AFC v. placebo) on each EEG frequency band, taking into account order of materials. Dependent variable = Treatment (EEG power during AFC, EEG power during placebo); independent variable = order (AFC/placebo, placebo/AFC) This is a pilot study, thus a power calculation was not done and it was not power to correct for multiple comparisons.||||>0.05
72624035|NCT02231580|144778432|SUPERIORITY_OR_OTHER||GLS mean ratio|1.564|||=|0.0204|TWO_SIDED|90.0|1.144|2.138|||MMRM|||Left foot IPI duration statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||2.138|1.144|=0.0204
72402177|NCT04452331|144311578|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|Mixed effects logistic regression including random effect of visit, to incorporate clustering of prescriptions within visits.||||||<.001
72402178|NCT04452331|144311578|SUPERIORITY|||||||0.98|||||||Mixed Models Analysis|Mixed effects logistic regression including random effect of visit, to incorporate clustering of prescriptions within visits.||||||0.98
72402179|NCT04452331|144311579|SUPERIORITY|||||||0.2|||||||Regression, Linear|||Systolic BP||||0.20
72402180|NCT04452331|144311579|SUPERIORITY|||||||0.82|||||||Regression, Linear|||Systolic BP||||0.82
72402181|NCT04452331|144311579|SUPERIORITY|||||||0.12|||||||Regression, Linear|||Diastolic BP||||0.12
72482626|NCT04908189|144492193|SUPERIORITY||Adjusted mean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.49||0.1924|TWO_SIDED|95.0|-1.6|0.3|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Week 2||0.3|-1.6|0.1924
72567072|NCT03545191|144665045|OTHER||LSGM ratio to placebo|0.73|||<|0.0001|TWO_SIDED|95.0|0.65|0.82||Mixed effects model for repeated measures: log(value/baseline) = log(baseline) + age group(\< 65; ≥ 65 years) + treatment + visit + treatment x visit + log(baseline) x visit.|Mixed Models Analysis|||Between-treatment analysis for change from baseline in log transformed LPS (min) to Month 1 (Daridorexant 50 mg vs placebo).||0.82|0.65|<0.0001
72567073|NCT03545191|144665046|OTHER||LSGM ratio to placebo|0.78||||0.0002|TWO_SIDED|95.0|0.68|0.89||Mixed effects model for repeated measures: log(value/baseline) = log(baseline) + age group(\< 65; ≥ 65 years) + treatment + visit + treatment x visit + log(baseline) x visit.|Mixed Models Analysis|||Between-treatment analysis for change from baseline in log transformed LPS (min) to Month 3 (Daridorexant 25 mg vs placebo).||0.89|0.68|0.0002
72402182|NCT04452331|144311579|SUPERIORITY|||||||0.1|||||||Regression, Linear|||Diastolic BP||||0.10
72402183|NCT01232920|144311597|SUPERIORITY_OR_OTHER|||||||0.09|||||||Fisher Exact|||||||0.09
72402184|NCT02211131|144311602|OTHER||Hazard Ratio (HR)|0.75||||0.07|TWO_SIDED|80.0|0.58|0.96||Unstratified log-rank test|Log Rank||Unstratified Hazard Ratio (T-VEC + Surgery / Surgery)|||0.96|0.58|0.070
72402185|NCT02211131|144311603|OTHER||Hazard Ratio (HR)|0.76||||0.092|TWO_SIDED|80.0|0.6|0.97||Unstratified log-rank test|Log Rank||Unstratified Hazard Ratio (T-VEC + Surgery / Surgery)|||0.97|0.60|0.092
72402186|NCT02211131|144311605|OTHER||Treatment Difference|4.3||||0.594|TWO_SIDED|80.0|-6.9|15.3||The two-sided p-value is based on the Pearson's Chi-square test.|Chi-squared||An 80% approximate exact CI for between-arm differences in binary rate is calculated using Wilson's score method with continuity correction.|||15.3|-6.9|0.594
72402187|NCT02211131|144311606|OTHER||Treatment Difference|14.4||||0.003|TWO_SIDED|80.0|7.4|21.6||The two-sided p-value is based on the Pearson's Chi-square test.|Chi-squared||80% exact CI for binary rate of each arm is calculated using the Clopper Pearson method.|||21.6|7.4|0.003
72402188|NCT02211131|144311611|OTHER||Hazard Ratio (HR)|0.54||||0.05|TWO_SIDED|80.0|0.36|0.81||Unstratified log-rank test|Log Rank||Unstratified Hazard Ratio (T-VEC + Surgery / Surgery)|||0.81|0.36|0.050
72402189|NCT00755131|144311637|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||t-test, 2 sided|||Sample size determination was based on a t-test assuming a normal distribution with non-equal variance with the mean and standard deviation for the experimental group (postinfarction patients) of HMGB1 levels equal to 15 ± 7 and 2 ± 1 ng/dl for the control group derived from a previous study, respectively. The required sample size was calculated to be 30 subjects per group to detect on the size of one SD with α value of 0.05 (two-sided) and power (1 - β) of 0.8.||||<0.05
72402190|NCT00755131|144311638|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||t-test, 2 sided|||||||<0.05
72402191|NCT00755131|144311639|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||t-test, 2 sided|||||||<0.05
72402192|NCT03167879|144311660|SUPERIORITY||Odds Ratio (OR)|10.63|||||TWO_SIDED|95.0|2.79|40.49||||||||40.49|2.79|
72402193|NCT03167879|144311661|SUPERIORITY||Odds Ratio (OR)|0.73|||||TWO_SIDED|95.0|0.25|2.09||||||||2.09|0.25|
72482627|NCT04908189|144492193|SUPERIORITY||Adjusted mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.51||0.7601|TWO_SIDED|95.0|-1.2|0.8|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Week 4||0.8|-1.20|0.7601
72482628|NCT04908189|144492193|SUPERIORITY||Adjusted mean difference|1.3|STANDARD_ERROR_OF_MEAN|0.59||0.0303|TWO_SIDED|95.0|0.1|2.4|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Week 8||2.4|0.1|0.0303
72482629|NCT04908189|144492193|SUPERIORITY||Adjusted mean difference|0.5|STANDARD_ERROR_OF_MEAN|0.63||0.4747|TWO_SIDED|95.0|-0.8|1.7|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Week 12||1.7|-0.8|0.4747
72482630|NCT04908189|144492193|SUPERIORITY||Adjusted mean difference|0.8|STANDARD_ERROR_OF_MEAN|0.61||0.2017|TWO_SIDED|95.0|-0.4|2.0|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Week 16||2.0|-0.4|0.2017
72482631|NCT04908189|144492195|SUPERIORITY||Adjusted mean difference|-0.077|STANDARD_ERROR_OF_MEAN|0.1015||0.4459|TWO_SIDED|95.0|-0.276|0.122|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Week 2||0.122|-0.276|0.4459
72482632|NCT04908189|144492195|SUPERIORITY||Adjusted mean difference|-0.232|STANDARD_ERROR_OF_MEAN|0.1164||0.0461|TWO_SIDED|95.0|-0.46|-0.004|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Week 4||-0.004|-0.460|0.0461
72482633|NCT04908189|144492195|SUPERIORITY||Adjusted mean difference|-0.598|STANDARD_ERROR_OF_MEAN|0.1321|<|0.0001|TWO_SIDED|95.0|-0.857|-0.339|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Week 8||-0.339|-0.857|<0.0001
72482634|NCT04908189|144492195|SUPERIORITY||Adjusted mean difference|-0.605|STANDARD_ERROR_OF_MEAN|0.1416|<|0.0001|TWO_SIDED|95.0|-0.882|-0.327|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Week 12||-0.327|-0.882|<0.0001
72482635|NCT04908189|144492195|SUPERIORITY||Adjusted mean difference|-0.786|STANDARD_ERROR_OF_MEAN|0.1455|<|0.0001|TWO_SIDED|95.0|-1.071|-0.501|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Week 16||-0.501|-1.071|<0.0001
72567074|NCT03545191|144665046|OTHER||LSGM ratio to placebo|0.73|||<|0.0001|TWO_SIDED|95.0|0.64|0.83||Mixed effects model for repeated measures: log(value/baseline) = log(baseline) + age group(\< 65; ≥ 65 years) + treatment + visit + treatment x visit + log(baseline) x visit.|Mixed Models Analysis|||Between-treatment analysis for change from baseline in log transformed LPS (min) to Month 3 (Daridorexant 50 mg vs placebo).||0.83|0.64|<0.0001
72482636|NCT04908189|144492196|SUPERIORITY||Adjusted mean difference|0.3525|STANDARD_ERROR_OF_MEAN|0.9227||0.7025|TWO_SIDED|95.0|-1.456|2.1609|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Week 2||2.1609|-1.4560|0.7025
72402194|NCT03167879|144311662|SUPERIORITY||Odds Ratio (OR)|2.23|||||TWO_SIDED|95.0|0.02|257.6||||||||257.6|0.02|
72482637|NCT04908189|144492196|SUPERIORITY||Adjusted mean difference|-1.373|STANDARD_ERROR_OF_MEAN|0.93331||0.1413|TWO_SIDED|95.0|-3.2023|0.4562|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Week 4||0.4562|-3.2023|0.1413
72482638|NCT04908189|144492196|SUPERIORITY||Adjused mean difference|-3.7522|STANDARD_ERROR_OF_MEAN|1.10374||0.0007|TWO_SIDED|95.0|-5.9155|-1.589|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Week 8||-1.5890|-5.9155|0.0007
72482639|NCT04908189|144492196|SUPERIORITY||Adjusted mean difference|-4.8072|STANDARD_ERROR_OF_MEAN|1.13857|<|0.0001|TWO_SIDED|95.0|-7.0388|-2.5757|||ANOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Week 12||-2.5757|-7.0388|<0.0001
72482640|NCT04908189|144492196|SUPERIORITY||Adjusted mean difference|-6.2006|STANDARD_ERROR_OF_MEAN|1.2284|<|0.0001|TWO_SIDED|95.0|-8.6082|-3.793|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Week 16||-3.7930|-8.6082|<0.0001
72482641|NCT04908189|144492200|SUPERIORITY||Adjusted mean difference|0.0318|STANDARD_ERROR_OF_MEAN|0.05613||0.5707|TWO_SIDED|95.0|-0.0782|0.1419|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Week 2||0.1419|-0.0782|0.5707
72482642|NCT04908189|144492200|SUPERIORITY||Adjusted mean difference|-0.0833|STANDARD_ERROR_OF_MEAN|0.06303||0.1862|TWO_SIDED|95.0|-0.2069|0.0402|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Week 4||0.0402|-0.2069|0.1862
72482643|NCT04908189|144492200|SUPERIORITY||Adjusted mean difference|-0.2958|STANDARD_ERROR_OF_MEAN|0.07854||0.0002|TWO_SIDED|95.0|-0.4497|-0.1418|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Week 8||-0.1418|-0.4497|0.0002
72482644|NCT04908189|144492200|SUPERIORITY||Adjusted mean difference|-0.3262|STANDARD_ERROR_OF_MEAN|0.083|<|0.0001|TWO_SIDED|95.0|-0.4889|-0.1635|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Week 12||-0.1635|-0.4889|<0.0001
72482645|NCT04908189|144492200|SUPERIORITY||Adjusted mean difference|-0.4743|STANDARD_ERROR_OF_MEAN|0.08735|<|0.0001|TWO_SIDED|95.0|-0.6455|-0.3031|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Week 16||-0.3031|-0.6455|<0.0001
72482646|NCT04908189|144492203|SUPERIORITY||Adjusted mean difference|-0.0758|STANDARD_ERROR_OF_MEAN|0.07069||0.2836|TWO_SIDED|95.0|-0.2144|0.0627|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Week 4||0.0627|-0.2144|0.2836
72482647|NCT04908189|144492203|SUPERIORITY||Adjusted mean difference|-0.5548|STANDARD_ERROR_OF_MEAN|0.09431|<|0.0001|TWO_SIDED|95.0|-0.7396|-0.3699|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Week 12||-0.3699|-0.7396|<0.0001
72482648|NCT04908189|144492203|SUPERIORITY||Adjusted mean difference|-0.5835|STANDARD_ERROR_OF_MEAN|0.10162|<|0.0001|TWO_SIDED|95.0|-0.7826|-0.3843|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Week 16||-0.3843|-0.7826|<0.0001
72402195|NCT01480076|144311664|SUPERIORITY_OR_OTHER||||||<|0.0001||||||within group p-value|mixed effect model|||Month 3: Mixed effect model for repeated measures with visit, baseline PCS score, baseline Expanded Disability Status Scale (EDSS) score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
72482649|NCT04908189|144492204|SUPERIORITY||Adjusted mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.12||0.2143|TWO_SIDED|95.0|-0.4|0.1|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Week 4||0.1|-0.4|0.2143
72482650|NCT04908189|144492204|SUPERIORITY||Adjusted mean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.13||0.0001|TWO_SIDED|95.0|-0.8|-0.2|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Week 8||-0.2|-0.8|0.0001
72482651|NCT04908189|144492204|SUPERIORITY||Adjusted mean difference|-0.7|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-1.0|-0.4|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Week 12||-0.4|-1.0|<0.0001
72567075|NCT01769274|144665060|OTHER|||||||1|||||||Hierarchical rank test|||||||1.0000
72567076|NCT01769274|144665060|OTHER|||||||1|||||||Hierarchical rank test|||||||1.0000
72567077|NCT03179163|144665077|OTHER||Mean Difference (Net)|0.01|||=|0.01|TWO_SIDED||||||ANOVA|||A priori power analysis (power = 0.80,a= 0.05) confirmed a sample size of n= 10 was needed to determine a meaningful difference of 10% in the (flux/MAP)\*logAch(mol/L) . All data were analyzed with repeated-measures ANOVA . When appropriate, post hoc Tukey-Kramer corrections were applied to correct for multiple comparisons. Significance was set a priori at a\<0.05.||||=0.01
72482652|NCT04908189|144492204|SUPERIORITY||Adjusted mean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-0.9|-0.4|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Week 16||-0.4|-0.9|<0.0001
72567078|NCT02377063|144665080|OTHER||Mean Difference (Final Values)|-11.2||||0.014|TWO_SIDED|||||p\<0.05 was defined as significant|ANOVA|||Comparison was made to day 4 minus day 0 (baseline) change of phylum Firmicutes after juice consumption||||0.014
72402196|NCT01480076|144311664|SUPERIORITY_OR_OTHER||||||<|0.0001||||||within group p-value|mixed effect model|||Month 6: Mixed effect model for repeated measures with visit, baseline PCS score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
72624036|NCT02231580|144778432|SUPERIORITY_OR_OTHER||GLS mean ratio|1.269|||=|0.3144|TWO_SIDED|90.0|0.856|1.884|||MMRM|||Right foot IPI duration statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||1.884|0.856|=0.3144
72624037|NCT02231580|144778433|SUPERIORITY_OR_OTHER||GLS mean ratio|1.914|||=|0.0324|TWO_SIDED|90.0|1.167|3.141|||MMRM|||Left foot ITI variability statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||3.141|1.167|=0.0324
72624038|NCT02231580|144778433|SUPERIORITY_OR_OTHER||GLS mean ratio|1.462|||=|0.246|TWO_SIDED|90.0|0.85|2.515|||MMRM|||Right foot ITI variability statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||2.515|0.85|=0.246
72402197|NCT01480076|144311664|SUPERIORITY_OR_OTHER||least squares mean|0.8|STANDARD_ERROR_OF_MEAN|0.22||0.0007|TWO_SIDED||||||mixed effect model|||Difference of Month 3 versus Month 6: Mixed effect model for repeated measures with visit, baseline PCS score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0007
72402198|NCT01480076|144311664|SUPERIORITY_OR_OTHER||||||<|0.0001||||||within-group p-value|mixed effect model|||Month 9: Mixed effect model for repeated measures with visit, baseline PCS score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
72567079|NCT02377063|144665080|OTHER||Mean Difference (Final Values)|10.5||||0.026|TWO_SIDED|||||p\<0.05 was defined as significant|ANOVA|||Comparison was made to day 4 minus day 0 (baseline) change of phylum Bacteroidetes after juice consumption||||0.026
72567080|NCT00775684|144665084|SUPERIORITY||||||=|0.1|||||||t-test, 2 sided|||Student t test||||=0.1
72567081|NCT00775684|144665084|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|||Repeated measure (baseline and 6 months)||||< 0.05
72567082|NCT00775684|144665085|SUPERIORITY||||||>|0.1|||||||t-test, 1 sided|||Within group changes over 6 months (delta= final - baseline) were compared.||||>0.1
72567083|NCT00775684|144665086|SUPERIORITY||||||>|0.1|||||||t-test, 1 sided|||To determine if exenatide or sitagliptin induced significant changes from baseline, the change for each measure (Δ = final - baseline) for each group was compared with the change in the glimepiride group using independent Student t tests||||>0.1
72567084|NCT00775684|144665087|SUPERIORITY||||||>|0.1|||||||t-test, 1 sided|||||||>0.1
72567085|NCT01277718|144665089|SUPERIORITY_OR_OTHER||Ratio of Least Squares (LS) Means (in %)|111.0|||||TWO_SIDED|90.0|98.02|124.99|||||LS mean was calculated from Analysis of variance (ANOVA). Data for AUCinf were natural log-transformed prior to analysis. Ratio of AUCinf LS means for log-transformed parameter (expressed as a percent).|||124.99|98.02|
72567086|NCT01277718|144665089|SUPERIORITY_OR_OTHER||Ratio of LS Means (in %)|96.2|||||TWO_SIDED|90.0|85.06|108.77|||||LS mean was calculated from ANOVA. Data for AUCinf were natural log-transformed prior to analysis. Ratio of AUCinf LS means for log-transformed parameter (expressed as a percent).|||108.77|85.06|
72567087|NCT01277718|144665089|SUPERIORITY_OR_OTHER||Ratio of LS Means (in %)|106.0|||||TWO_SIDED|90.0|94.53|119.91|||||LS mean was calculated from ANOVA. Data for AUCinf were natural log-transformed prior to analysis. Ratio of AUCinf LS means for log-transformed parameter (expressed as a percent).|||119.91|94.53|
72567088|NCT01277718|144665090|SUPERIORITY_OR_OTHER||Ratio of LS Means (in %)|100.0|||||TWO_SIDED|90.0|85.09|118.03|||||LS mean was calculated from ANOVA. Data for Cmax were natural log-transformed prior to analysis. Ratio of Cmax LS means for log-transformed parameter (expressed as a percent).|||118.03|85.09|
72567089|NCT01277718|144665090|SUPERIORITY_OR_OTHER||Ratio of LS Means (in %)|85.7|||||TWO_SIDED|90.0|72.51|101.33|||||LS mean was calculated from ANOVA. Data for Cmax were natural log-transformed prior to analysis. Ratio of Cmax LS means for log-transformed parameter (expressed as a percent).|||101.33|72.51|
72567090|NCT01277718|144665090|SUPERIORITY_OR_OTHER||Ratio of LS Means (in %)|85.9|||||TWO_SIDED|90.0|72.94|101.17|||||LS mean was calculated from ANOVA. Data for Cmax were natural log-transformed prior to analysis. Ratio of Cmax LS means for log-transformed parameter (expressed as a percent).|||101.17|72.94|
72567091|NCT02858726|144665141|SUPERIORITY||Mean Difference (Final Values)|-1.8|STANDARD_ERROR_OF_MEAN|0.5|<|0.001|TWO_SIDED|95.0|-2.8|-0.8|||Mixed Models Analysis|MMRM with effects for treatment, visit, treatment by visit interaction, and covariates for prior anti-itch medication usage and baseline score.||||-0.8|-2.8|<0.001
72567092|NCT02858726|144665141|SUPERIORITY||Mean Difference (Final Values)|-0.8|STANDARD_ERROR_OF_MEAN|0.5||0.107|TWO_SIDED|95.0|-1.9|0.2|||Mixed Models Analysis|MMRM with effects for treatment, visit, treatment by visit interaction, and covariates for prior anti-itch medication usage and baseline score.||||0.2|-1.9|0.107
72567093|NCT02858726|144665141|SUPERIORITY||Median Difference (Final Values)|-1.2|STANDARD_ERROR_OF_MEAN|0.5||0.019|TWO_SIDED|95.0|-2.3|-0.2|||Mixed Models Analysis|MMRM with effects for treatment, visit, treatment by visit interaction, and covariates for prior anti-itch medication usage and baseline score.||||-0.2|-2.3|0.019
72624039|NCT02231580|144778433|SUPERIORITY_OR_OTHER||GLS mean ratio|1.387|||=|0.1057|TWO_SIDED|90.0|0.994|1.935|||MMRM|||Left foot ITI duration statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||1.935|0.994|=0.1057
72624040|NCT02231580|144778433|SUPERIORITY_OR_OTHER||GLS mean ratio|1.074|||=|0.7342|TWO_SIDED|90.0|0.758|1.523|||MMRM|||Right foot ITI duration statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||1.523|0.758|=0.7342
72624041|NCT02231580|144778434|SUPERIORITY_OR_OTHER||GLS mean ratio|1.392|||=|0.1027|TWO_SIDED|90.0|0.997|1.943|||MMRM|||Left foot TF variability statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||1.943|0.997|=0.1027
72624042|NCT02231580|144778434|SUPERIORITY_OR_OTHER||GLS mean ratio|1.158|||=|0.4494|TWO_SIDED|90.0|0.84|1.595|||MMRM|||Right foot TF variability statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||1.595|0.840|=0.4494
72482653|NCT04908189|144492207|SUPERIORITY||Adjusted mean difference|-0.38|STANDARD_ERROR_OF_MEAN|1.801||0.8316|TWO_SIDED|95.0|-3.91|3.15|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Absenteeism||3.15|-3.91|0.8316
72482654|NCT04908189|144492207|SUPERIORITY||Adjusted mean difference|-2.95|STANDARD_ERROR_OF_MEAN|1.827||0.106|TWO_SIDED|95.0|-6.54|0.63|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Presenteeism||0.63|-6.54|0.1060
72624043|NCT02231580|144778435|SUPERIORITY_OR_OTHER||GLS mean ratio|0.699|||=|0.035|TWO_SIDED|90.0|0.53|0.922|||MMRM|||Left foot freq statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||0.922|0.530|=0.0350
72482655|NCT04908189|144492207|SUPERIORITY||Adjusted mean difference|-2.71|STANDARD_ERROR_OF_MEAN|1.918||0.1578|TWO_SIDED|95.0|-6.47|1.05|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Work Productivity||1.05|-6.47|0.1578
72482656|NCT04908189|144492207|SUPERIORITY||Adjusted mean difference|-7.59|STANDARD_ERROR_OF_MEAN|1.719|<|0.0001|TWO_SIDED|95.0|-10.96|-4.22|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Activity Impairment||-4.22|-10.96|<0.0001
72482657|NCT04908189|144492208|SUPERIORITY||Adjusted mean difference|-0.0026|STANDARD_ERROR_OF_MEAN|0.01224||0.8487|TWO_SIDED|95.0|-0.0291|0.0239|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Week 4 Utility Score||0.0239|-0.0291|0.8487
72482658|NCT04908189|144492208|SUPERIORITY||Adjusted mean difference|0.0365|STANDARD_ERROR_OF_MEAN|0.01531||0.0171|TWO_SIDED|95.0|0.0065|0.0665|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Week 16 Utility Score||0.0665|0.0065|0.0171
72482659|NCT04908189|144492208|SUPERIORITY||Adjusted mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.06||0.9254|TWO_SIDED|95.0|-0.1|0.1|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Week 4 Mobility||0.1|-0.1|0.9254
72482660|NCT04908189|144492208|SUPERIORITY||Adjusted mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.06||0.0566|TWO_SIDED|95.0|-0.2|0.0|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Week 16 Mobility||0.0|-0.2|0.0566
72624044|NCT02231580|144778435|SUPERIORITY_OR_OTHER||GLS mean ratio|0.853|||=|0.3556|TWO_SIDED|90.0|0.64|1.136|||MMRM|||Right foot freq statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||1.136|0.640|=0.3556
72482661|NCT04908189|144492208|SUPERIORITY||Ajudted mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.05||0.8933|TWO_SIDED|95.0|-0.1|0.1|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Week 4 Self-Care||0.1|-0.1|0.8933
72482662|NCT04908189|144492208|SUPERIORITY||Adjusted mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.05||0.0738|TWO_SIDED|95.0|-0.2|0.0|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Week 16 Self-Care||0.0|-0.2|0.0738
72482663|NCT04908189|144492208|SUPERIORITY||Adjusted mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.05||0.6176|TWO_SIDED|95.0|-0.1|0.1|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Week 4 Usual Activities||0.1|-0.1|0.6176
72482664|NCT04908189|144492208|SUPERIORITY||Adjusted mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.06||0.1544|TWO_SIDED|95.0|-0.2|0.0|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Week 16 Usual Activities||0.0|-0.2|0.1544
72482665|NCT04908189|144492208|SUPERIORITY||Adjusted mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.06||0.4707|TWO_SIDED|95.0|-0.2|0.1|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Week 4 Pain/Discomfort||0.1|-0.2|0.4707
72482666|NCT04908189|144492208|SUPERIORITY||Adjusted mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.06||0.0114|TWO_SIDED|95.0|-0.3|0.0|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Week 16 Pain/Discomfort||0.0|-0.3|0.0114
72482667|NCT04908189|144492208|SUPERIORITY||Adjusted mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.05||0.6594|TWO_SIDED|95.0|-0.1|0.1|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Week 4 Anxiety/Depression||0.1|-0.1|0.6594
72482668|NCT04908189|144492208|SUPERIORITY||Adjusted mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.06||0.7123|TWO_SIDED|95.0|-0.1|0.1|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Week 16 Anxiety/Depression||0.1|-0.1|0.7123
72482669|NCT04908189|144492209|SUPERIORITY||Adjusted mean difference|-0.01|STANDARD_ERROR_OF_MEAN|0.498||0.9834|TWO_SIDED|95.0|-0.99|0.97|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Week 4||0.97|-0.99|0.9834
72482670|NCT04908189|144492209|SUPERIORITY||Adjusted mean difference|-0.29|STANDARD_ERROR_OF_MEAN|0.565||0.6099|TWO_SIDED|95.0|-1.39|0.82|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Week 12||0.82|-1.39|0.6099
72482671|NCT04908189|144492209|SUPERIORITY||Adjusted mean difference|-0.66|STANDARD_ERROR_OF_MEAN|0.538||0.2205|TWO_SIDED|95.0|-1.71|0.4|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Week 16||0.40|-1.71|0.2205
72482672|NCT02083705|144492210|SUPERIORITY|||||||0.05|||||||t-test, 2 sided|||"We hypothesised that during neonatal CPR, CC+SI will reduce the time needed to achieve ROSC. Our aim was to examine if CC+SI reduces ROSC compared with 3:1 C:V CPR in preterm infants \<33 weeks of gestation.~For this pilot study, based on the local incidence of CPR in preterm neonates, a convenient sample size of five patients per group was enrolled. Our primary outcome was time to achieve ROSC measured using ECG."||||0.05
72482673|NCT02684357|144492211|OTHER||Adjusted percentage difference|72.5|||<|0.001|TWO_SIDED|95.0|66.8|78.2||Cochran-Mantel-Haenszel test adjusted for strata (baseline weight \[≤100 kg vs \>100 kg\] and prior exposure to tumor necrosis factor \[TNF\] antagonists \[0 vs ≥1\]). If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% CI for adjusted difference of 2 treatment groups, calculated from the Cochran-Mantel-Haenszel test adjusted for the comparison of 2 treatment groups. If there was a stratum containing zero count, 0.1 was added to each cell.|||78.2|66.8|< 0.001
72567094|NCT02858726|144665142|SUPERIORITY||Mean Difference (Final Values)|-10.4|STANDARD_ERROR_OF_MEAN|2.8|<|0.001|TWO_SIDED|95.0|-16.0|-4.8|||Mixed Models Analysis|MMRM with effects for treatment, visit, treatment by visit interaction, and covariates for prior anti-itch medication usage and baseline score.||||-4.8|-16.0|<0.001
72567095|NCT02858726|144665142|SUPERIORITY||Mean Difference (Final Values)|-7.2|STANDARD_ERROR_OF_MEAN|3.0||0.016|TWO_SIDED|95.0|-13.1|-1.4|||Mixed Models Analysis|MMRM with effects for treatment, visit, treatment by visit interaction, and covariates for prior anti-itch medication usage and baseline score.||||-1.4|-13.1|0.016
72567096|NCT02858726|144665142|SUPERIORITY||Mean Difference (Final Values)|-6.8|STANDARD_ERROR_OF_MEAN|3.0||0.026|TWO_SIDED|95.0|-12.8|-0.8|||Mixed Models Analysis|MMRM with effects for treatment, visit, treatment by visit interaction, and covariates for prior anti-itch medication usage and baseline score.||||-0.8|-12.8|0.026
72567097|NCT02340221|144665143|SUPERIORITY||Hazard Ratio (HR)|0.7||||0.0037|TWO_SIDED|95.0|0.56|0.89|||Log Rank|||||0.89|0.56|0.0037
72567098|NCT02340221|144665144|SUPERIORITY||Hazard Ratio (HR)|0.71||||0.0008|TWO_SIDED|95.0|0.58|0.87|||Log Rank|||||0.87|0.58|0.0008
72567099|NCT02340221|144665145|SUPERIORITY||Odds Ratio (OR)|3.0||||0.0002|TWO_SIDED|95.0|1.6|5.4|||Cochran-Mantel-Haenszel|||||5.4|1.6|0.0002
72567100|NCT02340221|144665146|SUPERIORITY||Odds Ratio (OR)|3.1|||<|0.0001|TWO_SIDED|95.0|1.7|5.4|||Cochran-Mantel-Haenszel|||||5.4|1.7|<0.0001
72567101|NCT02340221|144665147|SUPERIORITY||Hazard Ratio (HR)|0.85||||0.4151|TWO_SIDED|95.0|0.58|1.25|||Log Rank|||||1.25|0.58|0.4151
72567102|NCT02340221|144665148|SUPERIORITY||Hazard Ratio (HR)|1.0||||0.9974|TWO_SIDED|95.0|0.75|1.33|||Log Rank|||||1.33|0.75|0.9974
72567103|NCT02340221|144665149|SUPERIORITY||Odds Ratio (OR)|1.9|||||TWO_SIDED|95.0|1.2|2.9||||||||2.9|1.2|
72567104|NCT02340221|144665150|SUPERIORITY||Odds Ratio (OR)|1.9|||||TWO_SIDED|95.0|1.2|3.0||||||||3.0|1.2|
72567105|NCT02340221|144665151|SUPERIORITY||Hazard Ratio (HR)|0.77||||0.6708|TWO_SIDED|95.0|0.23|2.59|||Log Rank|||||2.59|0.23|0.6708
72567106|NCT02340221|144665152|SUPERIORITY||Hazard Ratio (HR)|1.09||||0.8286|TWO_SIDED|95.0|0.51|2.35|||Log Rank|||||2.35|0.51|0.8286
72567107|NCT02340221|144665153|SUPERIORITY||Hazard Ratio (HR)|0.66||||0.0023|TWO_SIDED|95.0|0.51|0.86|||Log Rank|||||0.86|0.51|0.0023
72567108|NCT02340221|144665154|SUPERIORITY||Hazard Ratio (HR)|0.72||||0.0095|TWO_SIDED|95.0|0.56|0.92|||Log Rank|||||0.92|0.56|0.0095
72402199|NCT01480076|144311664|SUPERIORITY_OR_OTHER||least squares mean|0.2|STANDARD_ERROR_OF_MEAN|0.21||0.2531|TWO_SIDED||||||mixed effect model|||Difference of Month 6 versus Month 9: Mixed effect model for repeated measures with visit, baseline PCS score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.2531
72567109|NCT01036490|144665175|SUPERIORITY_OR_OTHER|||||||0.04|||||||t-test, 2 sided|||||||0.04
72567110|NCT01036490|144665176|SUPERIORITY_OR_OTHER|||||||0.39|||||||t-test, 2 sided|||||||0.39
72482674|NCT02684357|144492212|OTHER||Adjusted percentage difference|78.5|||<|0.001|TWO_SIDED|95.0|72.4|84.5||Cochran-Mantel-Haenszel test adjusted for strata (baseline weight \[≤100 kg vs \>100 kg\] and prior exposure to tumor necrosis factor \[TNF\] antagonists \[0 vs ≥1\]). If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% CI for adjusted difference of 2 treatment groups, calculated by the Cochran-Mantel-Haenszel test adjusted for the comparison of 2 treatment groups. If there was a stratum containing zero count, 0.1 was added to each cell.|||84.5|72.4|< 0.001
72567111|NCT01036490|144665179|SUPERIORITY_OR_OTHER|||||||0.15|||||||t-test, 2 sided|||||||0.15
72567112|NCT01036490|144665180|SUPERIORITY_OR_OTHER|||||||0.58|||||||t-test, 2 sided|||||||0.58
72567113|NCT01172821|144665181|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.211|STANDARD_ERROR_OF_MEAN|0.027|<|0.0001|TWO_SIDED|95.0|0.159|0.264|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R2.5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||0.264|0.159|<0.0001
72567114|NCT01172821|144665181|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.169|STANDARD_ERROR_OF_MEAN|0.027|<|0.0001|TWO_SIDED|95.0|0.116|0.222|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||0.222|0.116|<0.0001
72567115|NCT01172821|144665182|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.176|STANDARD_ERROR_OF_MEAN|0.029|<|0.0001|TWO_SIDED|95.0|0.12|0.233|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R2.5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||0.233|0.120|<0.0001
72482675|NCT02684357|144492213|OTHER||Adjusted percentage difference|47.5|||<|0.001|TWO_SIDED|95.0|40.9|54.2||Cochran-Mantel-Haenszel test adjusted for strata (baseline weight \[≤100 kg vs \>100 kg\] and prior exposure to tumor necrosis factor \[TNF\] antagonists \[0 vs ≥1\]). If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% CI for adjusted difference of 2 treatment groups, calculated from the Cochran-Mantel-Haenszel test adjusted for the comparison of 2 treatment groups. If there was a stratum containing zero count, 0.1 was added to each cell.|||54.2|40.9|< 0.001
72482676|NCT02684357|144492214|OTHER||Adjusted percentage difference|48.2|||<|0.001|TWO_SIDED|95.0|41.9|54.6||Cochran-Mantel-Haenszel test adjusted for strata (baseline weight \[≤100 kg vs \>100 kg\] and prior exposure to tumor necrosis factor \[TNF\] antagonists \[0 vs ≥1\]). If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% CI for adjusted difference of 2 treatment groups, calculated from the Cochran-Mantel-Haenszel test adjusted for the comparison of 2 treatment groups. If there was a stratum containing zero count, 0.1 was added to each cell.|||54.6|41.9|< 0.001
72482677|NCT02684357|144492215|OTHER||Adjusted percentage difference|62.2|||<|0.001|TWO_SIDED|95.0|55.5|68.9||Cochran-Mantel-Haenszel test adjusted for strata (baseline weight \[≤100 kg vs \>100 kg\] and prior exposure to tumor necrosis factor \[TNF\] antagonists \[0 vs ≥1\]). If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% CI for adjusted difference of 2 treatment groups, calculated from the Cochran-Mantel-Haenszel test adjusted for the comparison of 2 treatment groups. If there was a stratum containing zero count, 0.1 was added to each cell.|||68.9|55.5|< 0.001
72482678|NCT02684357|144492216|OTHER||Adjusted percentage difference|31.2|||<|0.001|TWO_SIDED|95.0|25.7|36.6||Cochran-Mantel-Haenszel test adjusted for strata (baseline weight \[≤100 kg vs \>100 kg\] and prior exposure to tumor necrosis factor \[TNF\] antagonists \[0 vs ≥1\]). If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% CI for adjusted difference of 2 treatment groups, calculated from the Cochran-Mantel-Haenszel test adjusted for the comparison of 2 treatment groups. If there was a stratum containing zero count, 0.1 was added to each cell.|||36.6|25.7|< 0.001
72567116|NCT01172821|144665182|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.133|STANDARD_ERROR_OF_MEAN|0.029|<|0.0001|TWO_SIDED|95.0|0.076|0.19|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||0.190|0.076|<0.0001
72567117|NCT01172821|144665183|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.11|STANDARD_ERROR_OF_MEAN|0.03||0.0002|TWO_SIDED|95.0|0.052|0.168|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R2.5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||0.168|0.052|0.0002
72567118|NCT01172821|144665183|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.089|STANDARD_ERROR_OF_MEAN|0.03||0.0031|TWO_SIDED|95.0|0.03|0.147|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||0.147|0.030|0.0031
72482679|NCT02684357|144492217|OTHER||Adjusted percentage difference|27.6|||<|0.001|TWO_SIDED|95.0|16.7|38.5||Cochran-Mantel-Haenszel test adjusted for strata (baseline weight \[≤100 kg vs \>100 kg\] and prior exposure to tumor necrosis factor \[TNF\] antagonists \[0 vs ≥1\]). If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% CI for adjusted difference of 2 treatment groups, calculated from the Cochran-Mantel-Haenszel test adjusted for the comparison of 2 treatment groups. If there was a stratum containing zero count, 0.1 was added to each cell.|||38.5|16.7|< 0.001
72402200|NCT01480076|144311664|SUPERIORITY_OR_OTHER||||||<|0.0001||||||within group p-value|mixed effect model|||Month 12: Mixed effect model for repeated measures with visit, baseline PCS score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
72402201|NCT01480076|144311664|SUPERIORITY_OR_OTHER||least squares mean|0.3|STANDARD_ERROR_OF_MEAN|0.21||0.2299|TWO_SIDED||||||mixed effect model|||Difference of Month 9 versus Month 12: Mixed effect model for repeated measures with visit, baseline PCS score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.2299
72482680|NCT02684357|144492218|OTHER||Adjusted percentage difference|22.3|||<|0.001|TWO_SIDED|95.0|12.0|32.5||Cochran-Mantel-Haenszel test adjusted for strata (baseline weight \[≤100 kg vs \>100 kg\] and prior exposure to tumor necrosis factor \[TNF\] antagonists \[0 vs ≥1\]). If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% CI for adjusted difference of 2 treatment groups, calculated from the Cochran-Mantel-Haenszel test adjusted for the comparison of 2 treatment groups. If there was a stratum containing zero count, 0.1 was added to each cell.|||32.5|12.0|< 0.001
72482681|NCT02684357|144492219|OTHER||Adjusted percentage difference|27.0|||<|0.001|TWO_SIDED|95.0|17.0|37.0||Cochran-Mantel-Haenszel test adjusted for strata (baseline weight \[≤100 kg vs \>100 kg\] and prior exposure to tumor necrosis factor \[TNF\] antagonists \[0 vs ≥1\]). If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% CI for adjusted difference of 2 treatment groups, calculated from the Cochran-Mantel-Haenszel test adjusted for the comparison of 2 treatment groups. If there was a stratum containing zero count, 0.1 was added to each cell.|||37.0|17.0|< 0.001
72482682|NCT02684357|144492220|OTHER||Adjusted percentage difference|26.3|||<|0.001|TWO_SIDED|95.0|16.1|36.4||Cochran-Mantel-Haenszel test adjusted for strata (baseline weight \[≤100 kg vs \>100 kg\] and prior exposure to tumor necrosis factor \[TNF\] antagonists \[0 vs ≥1\]). If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% CI for adjusted difference of 2 treatment groups, calculated from the Cochran-Mantel-Haenszel test adjusted for the comparison of 2 treatment groups. If there was a stratum containing zero count, 0.1 was added to each cell.|||36.4|16.1|< 0.001
72482683|NCT02684357|144492221|OTHER||Adjusted percentage difference|30.2|||<|0.001|TWO_SIDED|95.0|19.6|40.9||Cochran-Mantel-Haenszel test adjusted for strata (baseline weight \[≤100 kg vs \>100 kg\] and prior exposure to tumor necrosis factor \[TNF\] antagonists \[0 vs ≥1\]). If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% CI for adjusted difference of 2 treatment groups, calculated from the Cochran-Mantel-Haenszel test adjusted for the comparison of 2 treatment groups. If there was a stratum containing zero count, 0.1 was added to each cell.|||40.9|19.6|< 0.001
72482684|NCT02684357|144492222|OTHER||Adjusted percentage difference|29.5|||<|0.001|TWO_SIDED|95.0|18.9|40.1||Cochran-Mantel-Haenszel test adjusted for strata (baseline weight \[≤100 kg vs \>100 kg\] and prior exposure to tumor necrosis factor \[TNF\] antagonists \[0 vs ≥1\]). If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% CI for adjusted difference of 2 treatment groups, calculated from the Cochran-Mantel-Haenszel test adjusted for the comparison of 2 treatment groups. If there was a stratum containing zero count, 0.1 was added to each cell.|||40.1|18.9|< 0.001
72482685|NCT02684357|144492223|OTHER||Adjusted percentage difference|29.5|||<|0.001|TWO_SIDED|95.0|18.9|40.1||Cochran-Mantel-Haenszel test adjusted for strata (baseline weight \[≤100 kg vs \>100 kg\] and prior exposure to tumor necrosis factor \[TNF\] antagonists \[0 vs ≥1\]). If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% CI for adjusted difference of 2 treatment groups, calculated from the Cochran-Mantel-Haenszel test adjusted for the comparison of 2 treatment groups. If there was a stratum containing zero count, 0.1 was added to each cell.|||40.1|18.9|< 0.001
72482686|NCT02684357|144492224|OTHER||Adjusted percentage difference|19.2|||<|0.001|TWO_SIDED|95.0|9.5|28.8||Cochran-Mantel-Haenszel test adjusted for strata (baseline weight \[≤100 kg vs \>100 kg\] and prior exposure to tumor necrosis factor \[TNF\] antagonists \[0 vs ≥1\]). If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% CI for adjusted difference of 2 treatment groups, calculated from the Cochran-Mantel-Haenszel test adjusted for the comparison of 2 treatment groups. If there was a stratum containing zero count, 0.1 was added to each cell.|||28.8|9.5|< 0.001
72482687|NCT02684357|144492225|OTHER||Adjusted percentage difference|18.0|||<|0.001|TWO_SIDED|95.0|7.8|28.3||Cochran-Mantel-Haenszel test adjusted for strata (baseline weight \[≤100 kg vs \>100 kg\] and prior exposure to tumor necrosis factor \[TNF\] antagonists \[0 vs ≥1\]). If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% CI for adjusted difference of 2 treatment groups, calculated from the Cochran-Mantel-Haenszel test adjusted for the comparison of 2 treatment groups. If there was a stratum containing zero count, 0.1 was added to each cell.|||28.3|7.8|< 0.001
72482688|NCT02684357|144492226|OTHER||Adjusted percentage difference|20.2|||<|0.001|TWO_SIDED|95.0|9.1|31.4||Cochran-Mantel-Haenszel test adjusted for strata (baseline weight \[≤100 kg vs \>100 kg\] and prior exposure to tumor necrosis factor \[TNF\] antagonists \[0 vs ≥1\]). If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% CI for adjusted difference of 2 treatment groups, calculated from the Cochran-Mantel-Haenszel test adjusted for the comparison of 2 treatment groups. If there was a stratum containing zero count, 0.1 was added to each cell.|||31.4|9.1|< 0.001
72624045|NCT05852340|144778446|OTHER|Analysis done using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Ratio (Test/Reference) and 90% confidence interval (CI) are expressed as percentages.|Ratio (%) of Adjusted Geometric Means|102.36|||||TWO_SIDED|90.0|95.81|109.35||||||Reference: Ritlecitinib 30 mg Capsule (Fasted) Test: Ritlecitinib 30 mg Capsule Mixed with Strawberry Jam (Fasted)||109.35|95.81|
72402202|NCT01480076|144311665|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Overall, Responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline PCS score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
72482689|NCT02684357|144492227|OTHER||Mean Difference (Final Values)|-6.375|||<|0.001|TWO_SIDED|95.0|-7.102|-5.648|||van Elteren test|||P-value calculated by the van Elteren test stratified for baseline weight (≤100 kg vs \>100 kg) and prior exposure to TNF antagonists (0 vs ≥1).||-5.648|-7.102|< 0.001
72482690|NCT02684357|144492228|OTHER||Adjusted percentage difference|84.7|||<|0.001|TWO_SIDED|95.0|79.0|90.4||Cochran-Mantel-Haenszel test adjusted for strata (baseline weight \[≤100 kg vs \>100 kg\] and prior exposure to tumor necrosis factor \[TNF\] antagonists \[0 vs ≥1\]). If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% CI for adjusted difference of 2 treatment groups, calculated from the Cochran-Mantel-Haenszel test adjusted for the comparison of 2 treatment groups. If there was a stratum containing zero count, 0.1 was added to each cell.|||90.4|79.0|< 0.001
72482691|NCT02684357|144492229|OTHER||Adjusted percentage difference|29.1|||<|0.001|TWO_SIDED|95.0|18.5|39.6||Cochran-Mantel-Haenszel test adjusted for strata (baseline weight \[≤100 kg vs \>100 kg\] and prior exposure to tumor necrosis factor \[TNF\] antagonists \[0 vs ≥1\]). If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% CI for adjusted difference of 2 treatment groups, calculated from the Cochran-Mantel-Haenszel test adjusted for the comparison of 2 treatment groups. If there was a stratum containing zero count, 0.1 was added to each cell.|||39.6|18.5|< 0.001
72482692|NCT02684357|144492230|OTHER||Adjusted percentage difference|14.7||||0.001|TWO_SIDED|95.0|5.9|23.5||Cochran-Mantel-Haenszel test adjusted for strata (baseline weight \[≤100 kg vs \>100 kg\] and prior exposure to tumor necrosis factor \[TNF\] antagonists \[0 vs ≥1\]). If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% CI for adjusted difference of 2 treatment groups, calculated from the Cochran-Mantel-Haenszel test adjusted for the comparison of 2 treatment groups. If there was a stratum containing zero count, 0.1 was added to each cell.|||23.5|5.9|0.001
72482693|NCT01839487|144492233|OTHER||Hazard Ratio (HR)|0.74||||0.058|TWO_SIDED|95.0|0.54|1.01||Threshold for significance at 0.1 level.|Log Rank|P-value was based on stratified log-rank test with the KPS category at screening as the stratification factor.||Hazard ratio PAG/AG was based on Cox proportional hazards model stratified by the Karnofsky Performance Status (KPS) category (70-80% and 90-100%) at screening using AG as the reference arm.||1.01|0.54|0.058
72482694|NCT01839487|144492235|OTHER||Hazard Ratio (HR)|0.57||||0.092|TWO_SIDED|95.0|0.3|1.1||Threshold for significance at 0.1 level.|Log Rank|P-value was based on stratified log-rank test with the KPS category at screening as the stratification factor.||Hazard ratio PAG/AG for HA-high was based on Cox proportional hazards model stratified by the KPS category (70-80% and 90-100%) at screening using AG as the reference arm.||1.10|0.30|0.092
72482695|NCT01839487|144492235|OTHER||Hazard Ratio (HR)|0.88||||0.514|TWO_SIDED|95.0|0.59|1.31||Threshold for significance at 0.1 level.|Log Rank|P-value was based on stratified log-rank test with the KPS category at screening as the stratification factor.||Hazard ratio PAG/AG for HA-low was based on Cox proportional hazards model stratified by the KPS category (70-80% and 90-100%) at screening using AG as the reference arm.||1.31|0.59|0.514
72567119|NCT01172821|144665184|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.087|STANDARD_ERROR_OF_MEAN|0.032||0.0061|TWO_SIDED|95.0|0.025|0.149|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R2.5 - Placebo|Analyses included the fixed, categorical effects of treatment, country, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||0.149|0.025|0.0061
72567120|NCT01172821|144665184|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.083|STANDARD_ERROR_OF_MEAN|0.032||0.0093|TWO_SIDED|95.0|0.021|0.146|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R5 - Placebo|Analyses included the fixed, categorical effects of treatment, country, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||0.146|0.021|0.0093
72567121|NCT01172821|144665185|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.201|STANDARD_ERROR_OF_MEAN|0.026|<|0.0001|TWO_SIDED|95.0|0.15|0.252|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R2.5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||0.252|0.150|<0.0001
72567122|NCT01172821|144665185|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.163|STANDARD_ERROR_OF_MEAN|0.026|<|0.0001|TWO_SIDED|95.0|0.112|0.215|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||0.215|0.112|<0.0001
72567123|NCT01172821|144665186|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.108|STANDARD_ERROR_OF_MEAN|0.029||0.0002|TWO_SIDED|95.0|0.052|0.164|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R2.5 - Placebo|Analyses included the fixed, categorical effects of treatment, country, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||0.164|0.052|0.0002
72482696|NCT01839487|144492236|OTHER||Risk Ratio (RR)|1.22||||0.225|TWO_SIDED|95.0|0.88|1.68||Threshold for significance at 0.1 level.|Cochran-Mantel-Haenszel|||p-Value and relative risk were based on a stratified Cochran-Mantel-Haenszel method using KPS category at screening as the stratification factor.||1.68|0.88|0.225
72482697|NCT01839487|144492237|OTHER||Hazard Ratio (HR)|0.91||||0.495|TWO_SIDED|95.0|0.7|1.19||Threshold for significance at 0.1 level.|Log Rank|P-value was based on stratified log-rank test with the KPS category at screening as the stratification factor.||Hazard ratio PAG/AG was based on Cox proportional hazards model stratified by the KPS category (70-80% and 90-100%) at screening using AG as the reference arm.||1.19|0.70|0.495
72482698|NCT01658826|144492245|SUPERIORITY||Risk Ratio (RR)|0.43|||<|0.0001|TWO_SIDED|95.0|0.3|0.63|||non-linear mixed effects model|||||0.63|0.30|<0.0001
72482699|NCT02525861|144492288|OTHER||Geometric Mean Ratio|5.398|||<|0.001|||||||Mixed-effects model|||Statistical analysis was collected and assessed based on A1P1 Levels at baseline and On-treatment BAL visit.||||<0.001
72482700|NCT02525861|144492289|OTHER||Geometric Mean Ratio|2.259|||<|0.001|||||||mixed-effects model|||Statistical analysis was collected and assessed based on functional A1P1 Levels at baseline and On-treatment BAL visit.||||<0.001
72482701|NCT04796896|144492313|NON_INFERIORITY|"The noninferiority of GM value (based on GLSM) was considered demonstrated if:~The lower bound of the 95% confidence interval (CI) of the geometric mean ratio (GMR) was \>0.667 based on the noninferiority margin of 1.5, and the GMR point estimate ≥0.8 (minimum threshold)."|GMR|1.224|||||TWO_SIDED|95.0|1.061|1.413||||||||1.413|1.061|
72482702|NCT04796896|144492314|NON_INFERIORITY|"The noninferiority of GM value (based on GLSM) was considered demonstrated if the following were true:~The lower bound of the 95% CI of the GMR was \>0.667 based on the noninferiority margin of 1.5, and the GMR point estimate ≥0.8 (minimum threshold)."|GMR|0.995|||||TWO_SIDED|95.0|0.87|1.139||||||||1.139|0.870|
72482703|NCT04796896|144492314|NON_INFERIORITY|"The noninferiority of GM value (based on GLSM) was considered demonstrated if the following were true:~The lower bound of the 95% CI of the GMR was \>0.667 based on the noninferiority margin of 1.5, and the GMR point estimate ≥0.8 (minimum threshold)."|GMR|1.257|||||TWO_SIDED|95.0|1.101|1.434||||||||1.434|1.101|
72482704|NCT04796896|144492315|NON_INFERIORITY|The noninferiority of the SRR was considered demonstrated if the following were true: The lower bound of the 95% CI of the SRR difference was \>-10% based on the noninferiority margin of 10% and the SRR difference point estimate was ≥-5% (minimum threshold).|percentage difference|-0.3|||||TWO_SIDED|95.0|-2.2|1.6||||||||1.6|-2.2|
72482705|NCT04796896|144492316|NON_INFERIORITY|The noninferiority of the SRR was considered demonstrated if the following were true: The lower bound of the 95% CI of the SRR difference was \>-10% based on the noninferiority margin of 10% and the SRR difference point estimate was ≥-5% (minimum threshold).|percentage difference|-0.4|||||TWO_SIDED|95.0|-2.5|1.5||||||||1.5|-2.5|
72482706|NCT04796896|144492316|NON_INFERIORITY|The noninferiority of the SRR was considered demonstrated if the following were true: The lower bound of the 95% CI of the SRR difference was \>-10% based on the noninferiority margin of 10% and the SRR difference point estimate was ≥-5% (minimum threshold).|percentage difference|0.7|||||TWO_SIDED|95.0|-0.8|2.4||||||||2.4|-0.8|
72482707|NCT04796896|144492317|NON_INFERIORITY|"The noninferiority of GM value (based on GLSM) was considered demonstrated if the following were true:~The lower bound of the 95% CI of the GMR was \>0.667 based on the noninferiority margin of 1.5, and the GMR point estimate ≥0.8 (minimum threshold)."|GMR|3.897|||||TWO_SIDED|95.0|3.158|4.808||||||||4.808|3.158|
72482708|NCT04796896|144492317|NON_INFERIORITY|"The noninferiority of GM value (based on GLSM) was considered demonstrated if the following were true:~The lower bound of the 95% CI of the GMR was \>0.667 based on the noninferiority margin of 1.5, and the GMR point estimate ≥0.8 (minimum threshold)."|GMR|3.982|||||TWO_SIDED|95.0|3.404|4.657||||||||4.657|3.404|
72482709|NCT04796896|144492319|NON_INFERIORITY|The noninferiority of the SRR was considered demonstrated if the following were true: The lower bound of the 95% CI of the SRR difference was \>-10% based on the noninferiority margin of 10% and the SRR difference point estimate was ≥-5% (minimum threshold).|percentage difference|0.7|||||TWO_SIDED|95.0|-4.4|2.4||||||||2.4|-4.4|
72482710|NCT04796896|144492319|NON_INFERIORITY|The noninferiority of the SRR was considered demonstrated if the following were true: The lower bound of the 95% CI of the SRR difference was \>-10% based on the noninferiority margin of 10% and the SRR difference point estimate was ≥-5% (minimum threshold).|percentage difference|0.7|||||TWO_SIDED|95.0|-2.2|2.4||||||||2.4|-2.2|
72482711|NCT04796896|144492328|OTHER|The 95% confidence interval (CI) of the ratio was calculated using the exact method conditional upon the total number of cases, adjusting for person-years.|Vaccine Efficacy|0.706|||||TWO_SIDED|95.0|0.325|0.873|||||Vaccine efficacy (percent), was defined as 1 - ratio of incidence rate (mRNA-1273 vs. placebo).|||0.873|0.325|
72482712|NCT04796896|144492328|OTHER|The 95% CI of the ratio was calculated using the exact method conditional upon the total number of cases, adjusting for person-years.|Vaccine Efficacy|0.409|||||TWO_SIDED|95.0|0.287|0.509|||||Vaccine Efficacy (percent), was defined as 1 - ratio of incidence rate (mRNA-1273 vs. placebo).|||0.509|0.287|
72482713|NCT04796896|144492328|OTHER|The 95% CI of the ratio was calculated using the exact method conditional upon the total number of cases, adjusting for person-years.|Vaccine Efficacy|0.324|||||TWO_SIDED|95.0|0.127|0.474|||||Vaccine Efficacy (percent), was defined as 1 - ratio of incidence rate (mRNA-1273 vs. placebo).|||0.474|0.127|
72482714|NCT04796896|144492329|OTHER|The 95% CI of the ratio was calculated using the exact method conditional upon the total number of cases, adjusting for person-years.|Vaccine Efficacy|0.683|||||TWO_SIDED|95.0|0.151|0.882|||||Vaccine Efficacy (percent), was defined as 1 - ratio of incidence rate (mRNA-1273 vs. placebo).|||0.882|0.151|
72482715|NCT04796896|144492329|OTHER|The 95% CI of the ratio was calculated using the exact method conditional upon the total number of cases, adjusting for person-years.|Vaccine Efficacy|0.281|||||TWO_SIDED|95.0|-0.007|0.48|||||Vaccine Efficacy (percent), was defined as 1 - ratio of incidence rate (mRNA-1273 vs. placebo).|||0.480|-0.007|
72482716|NCT04796896|144492329|OTHER|The 95% CI of the ratio was calculated using the exact method conditional upon the total number of cases, adjusting for person-years.|Vaccine Efficacy|-0.068|||||TWO_SIDED|95.0|-0.832|0.352|||||Vaccine Efficacy (percent), was defined as 1 - ratio of incidence rate (mRNA-1273 vs. placebo).|||0.352|-0.832|
72482717|NCT04796896|144492330|OTHER|The 95% CI of the ratio was calculated using the exact method conditional upon the total number of cases, adjusting for person-years.|Vaccine Efficacy|0.76|||||TWO_SIDED|95.0|-0.416|0.965|||||Vaccine Efficacy (percent), was defined as 1 - ratio of incidence rate (mRNA-1273 vs. placebo).|||0.965|-0.416|
72482718|NCT04796896|144492330|OTHER|The 95% CI of the ratio was calculated using the exact method conditional upon the total number of cases, adjusting for person-years.|Vaccine Efficacy|0.466|||||TWO_SIDED|95.0|0.328|0.574|||||Vaccine Efficacy (percent), was defined as 1 - ratio of incidence rate (mRNA-1273 vs. placebo).|||0.574|0.328|
72482719|NCT04796896|144492330|OTHER|The 95% CI of the ratio was calculated using the exact method conditional upon the total number of cases, adjusting for person-years.|Vaccine Efficacy|0.432|||||TWO_SIDED|95.0|0.232|0.576|||||Vaccine Efficacy (percent), was defined as 1 - ratio of incidence rate (mRNA-1273 vs. placebo).|||0.576|0.232|
72482720|NCT04356183|144492332|SUPERIORITY||||||<|0.05|||||||Regression, Linear|||||||<0.05
72482721|NCT04356183|144492333|SUPERIORITY||||||<|0.05|||||||Regression, Linear|||||||<0.05
72482722|NCT04356183|144492334|SUPERIORITY||||||<|0.05|||||||Regression, Linear|||||||<0.05
72482723|NCT01177787|144492336|OTHER||Mean Difference (Final Values)|-0.669|STANDARD_DEVIATION|0.03||0.503|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||0.503
72511379|NCT03342469|144553239|OTHER||||||>|0.05||||||Significance level \</= 0.05. This was chosen due to the small sample size. The p-value is not adjusted for multiple comparisons as this was a pilot study and a power analysis for sample size was not conducted.|repeated measures General Linear Model|||Difference in Alpha Power in control group with and without exposure to AFC. General linear model assessed the impact of treatment (AFC v. placebo) on each EEG frequency band, taking into account order of materials. Dependent variable = Treatment (EEG power during AFC, EEG power during placebo); independent variable = order (AFC/placebo, placebo/AFC) This is a pilot study, thus a power calculation was not done and it was not power to correct for multiple comparisons.||||>0.05
72511380|NCT03342469|144553239|OTHER||||||>|0.05||||||Significance level \</= 0.05. This was chosen due to the small sample size. The p-value is not adjusted for multiple comparisons as this was a pilot study and a power analysis for sample size was not conducted.|repeated measures General Linear Model|||Difference in Beta Power in control group with and without exposure to AFC. General linear model assessed the impact of treatment (AFC v. placebo) on each EEG frequency band, taking into account order of materials. Dependent variable = Treatment (EEG power during AFC, EEG power during placebo); independent variable = order (AFC/placebo, placebo/AFC)||||>0.05
72511381|NCT03342469|144553239|OTHER||||||>|0.05||||||Significance level \</= 0.05. This was chosen due to the small sample size. The p-value is not adjusted for multiple comparisons as this was a pilot study and a power analysis for sample size was not conducted.|repeated measures General Linear Model|||"Difference in Gamma Power in control group with and without exposure to AFC. General linear model assessed the impact of treatment (AFC v. placebo) on each EEG frequency band, taking into account order of materials. Dependent variable = Treatment (EEG power during AFC, EEG power during placebo); independent variable = order (AFC/placebo, placebo/AFC)~This is a pilot study, thus a power calculation was not done and it was not power to correct for multiple comparisons."||||>0.05
72482724|NCT00402363|144492340|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.15||||0.263|TWO_SIDED|95.0|0.9|1.46|||Regression, Cox|||||1.46|0.90|0.263
72482725|NCT00402363|144492341|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.64||||0.089|TWO_SIDED|95.0|0.92|2.92|||Log Rank|||||2.92|0.92|0.089
72482726|NCT00402363|144492341|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.22||||0.081|TWO_SIDED|95.0|0.98|1.52|||Regression, Cox|||||1.52|0.98|0.081
72482727|NCT00402363|144492342|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.17||||0.213|TWO_SIDED|95.0|0.91|1.49|||Regression, Cox|||||1.49|0.91|0.213
72482728|NCT00402363|144492342|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.5||||0.171|TWO_SIDED|95.0|0.83|2.69|||Log Rank|||||2.69|0.83|0.171
72482729|NCT00402363|144492343|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.22||||0.082|TWO_SIDED|95.0|0.98|1.53|||Regression, Cox|||||1.53|0.98|0.082
72482730|NCT00402363|144492344|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.12||||0.331|TWO_SIDED|95.0|0.89|1.4|||Regression, Cox|||||1.40|0.89|0.331
72482731|NCT00402363|144492344|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.29||||0.297|TWO_SIDED|95.0|0.79|2.11|||Log Rank|||||2.11|0.79|0.297
72482732|NCT00402363|144492345|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.16||||0.168|TWO_SIDED|95.0|0.94|1.42|||Regression, Cox|||||1.42|0.94|0.168
72482733|NCT00402363|144492346|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.14||||0.27|TWO_SIDED|95.0|0.9|1.43|||Regression, Cox|||||1.43|0.90|0.270
72482734|NCT00402363|144492346|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.19||||0.486|TWO_SIDED|95.0|0.73|1.95|||Log Rank|||||1.95|0.73|0.486
72482735|NCT00402363|144492347|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.16||||0.167|TWO_SIDED|95.0|0.94|1.42|||Regression, Cox|||||1.42|0.94|0.167
72482736|NCT00402363|144492348|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.09||||0.565|TWO_SIDED|95.0|0.81|1.47|||Regression, Cox|||||1.47|0.81|0.565
72482737|NCT00402363|144492348|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.68||||0.103|TWO_SIDED|95.0|0.89|3.15|||Log Rank|||||3.15|0.89|0.103
72482738|NCT00402363|144492349|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.2||||0.185|TWO_SIDED|95.0|0.92|1.56|||Regression, Cox|||||1.56|0.92|0.185
72482739|NCT00402363|144492350|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.12||||0.461|TWO_SIDED|95.0|0.83|1.51|||Regression, Cox|||||1.51|0.83|0.461
72482740|NCT00402363|144492350|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.51||||0.206|TWO_SIDED|95.0|0.79|2.86|||Log Rank|||||2.86|0.79|0.206
72482741|NCT00402363|144492351|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.2||||0.188|TWO_SIDED|95.0|0.92|1.57|||Regression, Cox|||||1.57|0.92|0.188
72482742|NCT00402363|144492352|SUPERIORITY_OR_OTHER||median difference (Hodges-Lehmann)|0.07||||0.29|TWO_SIDED|95.0|-0.09|2.08|||non-parametric ANCOVA|||||2.08|-0.09|0.290
72482743|NCT00402363|144492352|SUPERIORITY_OR_OTHER||median difference (Hodges-Lehmann)|0.063||||0.479|TWO_SIDED|95.0|-0.08|2.02|||Wilcoxon (Mann-Whitney)|||||2.02|-0.08|0.479
72482744|NCT00402363|144492352|SUPERIORITY_OR_OTHER||median difference (Hodges-Lehmann)|0.039||||0.218|TWO_SIDED|95.0|-0.06|1.49|||non-parametric ANCOVA|||||1.49|-0.06|0.218
72511382|NCT03342469|144553240|OTHER||||||>|0.05||||||Significance level \</= 0.05. This was chosen due to the small sample size. The p-value is not adjusted for multiple comparisons as this was a pilot study and a power analysis for sample size was not conducted.|repeated measures General Linear Model|||"Difference in Delta Power in ADHD group with and without exposure to AFC. General linear model assessed the impact of treatment (AFC v. placebo) on each EEG frequency band, taking into account order of materials. Dependent variable = Treatment (EEG power during AFC, EEG power during placebo); independent variable = order (AFC/placebo, placebo/AFC)~This is a pilot study, thus a power calculation was not done and it was not power to correct for multiple comparisons."||||>0.05
72511383|NCT03342469|144553240|OTHER||||||>|0.05||||||Significance level \</= 0.05. This was chosen due to the small sample size. The p-value is not adjusted for multiple comparisons as this was a pilot study and a power analysis for sample size was not conducted.|repeated measures General Linear Model|||"Difference in Theta Power in ADHD group with and without exposure to AFC. General linear model assessed the impact of treatment (AFC v. placebo) on each EEG frequency band, taking into account order of materials. Dependent variable = Treatment (EEG power during AFC, EEG power during placebo); independent variable = order (AFC/placebo, placebo/AFC)~This is a pilot study, thus a power calculation was not done and it was not power to correct for multiple comparisons."||||>0.05
72511384|NCT03342469|144553240|OTHER|||||||0.04||||||Significance level \</= 0.05. This was chosen due to the small sample size. The p-value is not adjusted for multiple comparisons as this was a pilot study and a power analysis for sample size was not conducted.|repeated measures General Linear Model|F(1.14)= 4.88, p=0.04||"Difference in Alpha Power in ADHD group with and without exposure to AFC. General linear model assessed the impact of treatment (AFC v. placebo) on each EEG frequency band, taking into account order of materials. Dependent variable = Treatment (EEG power during AFC, EEG power during placebo); independent variable = order (AFC/placebo, placebo/AFC)~This is a pilot study, thus a power calculation was not done and it was not power to correct for multiple comparisons."||||0.04
72567124|NCT01172821|144665186|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.089|STANDARD_ERROR_OF_MEAN|0.029||0.0019|TWO_SIDED|95.0|0.033|0.145|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R5 - Placebo|Analyses included the fixed, categorical effects of treatment, country, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||0.145|0.033|0.0019
72567125|NCT01172821|144665187|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|28.759|STANDARD_ERROR_OF_MEAN|4.963|<|0.0001|TWO_SIDED|95.0|19.025|38.494|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R2.5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||38.494|19.025|<0.0001
72567126|NCT01172821|144665187|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|28.178|STANDARD_ERROR_OF_MEAN|4.985|<|0.0001|TWO_SIDED|95.0|18.401|37.956|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||37.956|18.401|<0.0001
72567127|NCT01172821|144665188|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.011|STANDARD_ERROR_OF_MEAN|0.068||0.87|TWO_SIDED|95.0|-0.122|0.144|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R2.5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||0.144|-0.122|0.8700
72624046|NCT05852340|144778446|OTHER|Analysis done using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Ratio (Test/Reference) and 90% CI are expressed as percentages.|Ratio (%) of Adjusted Geometric Means|97.15|||||TWO_SIDED|90.0|90.94|103.79||||||Reference: Ritlecitinib 30 mg Capsule (Fasted) Test: Ritlecitinib 30 mg Capsule Mixed with Yoghurt (Fasted)||103.79|90.94|
72482745|NCT00402363|144492353|SUPERIORITY_OR_OTHER||median difference (Hodges-Lehmann)|0.321||||0.218|TWO_SIDED|95.0|-0.18|2.21|||non-parametric ANCOVA|||||2.21|-0.18|0.218
72482746|NCT00402363|144492353|SUPERIORITY_OR_OTHER||median difference (Hodges-Lehmann)|0.216||||0.188|TWO_SIDED|95.0|-0.14|3.14|||Wilcoxon (Mann-Whitney)|||||3.14|-0.14|0.188
72482747|NCT00402363|144492353|SUPERIORITY_OR_OTHER||median difference (Hodges-Lehmann)|0.181||||0.097|TWO_SIDED|95.0|-0.1|2.1|||non-parametric ANCOVA|||||2.10|-0.10|0.097
72482748|NCT00402363|144492354|SUPERIORITY_OR_OTHER||median difference (Hodges-Lehmann)|0.242||||0.239|TWO_SIDED|95.0|-0.19|2.17|||non-parametric ANCOVA|||||2.17|-0.19|0.239
72482749|NCT00402363|144492354|SUPERIORITY_OR_OTHER||median difference (Hodges-Lehmann)|0.249||||0.152|TWO_SIDED|95.0|-0.09|4.31|||Wilcoxon (Mann-Whitney)|||||4.31|-0.09|0.152
72482750|NCT00402363|144492354|SUPERIORITY_OR_OTHER||median difference (Hodges-Lehmann)|0.2||||0.094|TWO_SIDED|95.0|-0.08|2.11|||non-parametric ANCOVA|||||2.11|-0.08|0.094
72482751|NCT02634346|144492355|SUPERIORITY||Least square mean difference|-6.4|STANDARD_ERROR_OF_MEAN|1.83|<|0.001|TWO_SIDED|95.0|-10.0|-2.8|||Mixed Models Analysis|Mixed model for repeated measures is based on observed data without imputation of missing data.||||-2.8|-10.0|<0.001
72482752|NCT02634346|144492355|SUPERIORITY||Least square mean difference|-5.3|STANDARD_ERROR_OF_MEAN|1.84||0.004|TWO_SIDED|95.0|-8.9|-1.7|||Mixed Models Analysis|Mixed model for repeated measures is based on observed data without imputation of missing data.||||-1.7|-8.9|0.004
72482753|NCT02634346|144492356|SUPERIORITY||Least square mean difference|-0.38|STANDARD_ERROR_OF_MEAN|0.118||0.002|TWO_SIDED|95.0|-0.61|-0.14|||Mixed Models Analysis|Mixed model for repeated measures is based on observed data without imputation of missing data.||||-0.14|-0.61|0.002
72482754|NCT02634346|144492356|SUPERIORITY||Least square mean difference|-0.44|STANDARD_ERROR_OF_MEAN|0.118|<|0.001|TWO_SIDED|95.0|-0.67|-0.2|||Mixed Models Analysis|Mixed model for repeated measures is based on observed data without imputation of missing data.||||-0.20|-0.67|<0.001
72624047|NCT05852340|144778446|OTHER|Analysis done using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Ratio (Test/Reference) and 90% CI are expressed as percentages.|Ratio (%) of Adjusted Geometric Means|99.65|||||TWO_SIDED|90.0|93.28|106.46||||||Reference: Ritlecitinib 30 mg Capsule (Fasted) Test: Ritlecitinib 30 mg Capsule Mixed with Applesauce (Fasted)||106.46|93.28|
72624048|NCT05852340|144778446|OTHER|Analysis done using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Ratio (Test/Reference) and 90% CI are expressed as percentages.|Ratio (%) of Adjusted Geometric Means|104.84|||||TWO_SIDED|90.0|97.3|112.96||||||Reference: Ritlecitinib 30 mg Capsule (Fasted) Test: Ritlecitinib 30 mg Capsule Given with High Fat Meal||112.96|97.30|
72624049|NCT05852340|144778447|OTHER|Analysis done using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Ratio (Test/Reference) and 90% CI are expressed as percentages.|Ratio (%) of Adjusted Geometric Means|96.63|||||TWO_SIDED|90.0|83.66|111.62||||||Reference: Ritlecitinib 30 mg Capsule (Fasted) Test: Ritlecitinib 30 mg Capsule Mixed with Strawberry Jam (Fasted)||111.62|83.66|
72624050|NCT05852340|144778447|OTHER|Analysis done using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Ratio (Test/Reference) and 90% CI are expressed as percentages.|Ratio (%) of Adjusted Geometric Means|84.58|||||TWO_SIDED|90.0|73.23|97.7||||||Reference: Ritlecitinib 30 mg Capsule (Fasted) Test: Ritlecitinib 30 mg Capsule Mixed with Yoghurt (Fasted)||97.70|73.23|
72482755|NCT01676909|144492382|SUPERIORITY|||||||0.362|||||||Mixed Models Analysis|||To test hypothesis 1, regarding the three SF-12 subscales, a linear mixed effects models was used. All available data were used from all three assessment time points. Group, time, and group-by-time terms were included in the model. To test for a group difference in mean change from baseline to post-intervention, the significance test of the group-by-post-intervention coefficient was performed. A logistic mixed model for change in proportion with an ED visit was used to test hypothesis 2.||||0.362
72482756|NCT01676909|144492383|SUPERIORITY|||||||0.026|||||||Mixed Models Analysis|||To test hypothesis 1, regarding the three SF-12 subscales, a linear mixed effects models was used. All available data were used from all three assessment time points. Group, time, and group-by-time terms were included in the model. To test for a group difference in mean change from baseline to post-intervention, the significance test of the group-by-post-intervention coefficient was performed. A logistic mixed model for change in proportion with an ED visit was used to test hypothesis 2.||||0.026
72482757|NCT01676909|144492384|SUPERIORITY|||||||0.032|||||||Mixed Models Analysis|||To test hypothesis 1, regarding the three SF-12 subscales, a linear mixed effects models was used. All available data were used from all three assessment time points. Group, time, and group-by-time terms were included in the model. To test for a group difference in mean change from baseline to post-intervention, the significance test of the group-by-post-intervention coefficient was performed. A logistic mixed model for change in proportion with an ED visit was used to test hypothesis 2.||||0.032
72511385|NCT03342469|144553240|OTHER||||||>|0.05||||||Significance level \</= 0.05. This was chosen due to the small sample size. The p-value is not adjusted for multiple comparisons as this was a pilot study and a power analysis for sample size was not conducted.|repeated measures General Linear Model|||"Difference in Beta Power in ADHD group with and without exposure to AFC. General linear model assessed the impact of treatment (AFC v. placebo) on each EEG frequency band, taking into account order of materials. Dependent variable = Treatment (EEG power during AFC, EEG power during placebo); independent variable = order (AFC/placebo, placebo/AFC)~This is a pilot study, thus a power calculation was not done and it was not power to correct for multiple comparisons."||||>0.05
72511386|NCT03342469|144553240|OTHER||||||>|0.05||||||Significance level \</= 0.05. This was chosen due to the small sample size. The p-value is not adjusted for multiple comparisons as this was a pilot study and a power analysis for sample size was not conducted.|repeated measures General Linear Model|||"Difference in Gamma Power in ADHD group with and without exposure to AFC. General linear model assessed the impact of treatment (AFC v. placebo) on each EEG frequency band, taking into account order of materials. Dependent variable = Treatment (EEG power during AFC, EEG power during placebo); independent variable = order (AFC/placebo, placebo/AFC)~This is a pilot study, thus a power calculation was not done and it was not power to correct for multiple comparisons."||||>0.05
72511387|NCT03342469|144553240|OTHER||||||>|0.05||||||Significance level \</= 0.05. This was chosen due to the small sample size. The p-value is not adjusted for multiple comparisons as this was a pilot study and a power analysis for sample size was not conducted.|repeated measures General Linear Model|||"Difference in Delta Power in control group with and without exposure to AFC. General linear model assessed the impact of treatment (AFC v. placebo) on each EEG frequency band, taking into account order of materials. Dependent variable = Treatment (EEG power during AFC, EEG power during placebo); independent variable = order (AFC/placebo, placebo/AFC)~This is a pilot study, thus a power calculation was not done and it was not power to correct for multiple comparisons."||||>0.05
72567128|NCT01172821|144665188|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.003|STANDARD_ERROR_OF_MEAN|0.068||0.9612|TWO_SIDED|95.0|-0.137|0.13|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||0.130|-0.137|0.9612
72567129|NCT01172821|144665189|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.127|STANDARD_ERROR_OF_MEAN|0.059||0.0305|TWO_SIDED|95.0|-0.241|-0.012|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R2.5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||-0.012|-0.241|0.0305
72482758|NCT01676909|144492385|SUPERIORITY|||||||0.64|||||||Mixed Models Analysis|||A logistic mixed effects model over two 6-month time periods (prior to baseline and between baseline and the 6-month follow-up visit) was used. Terms in the model included group, binary time (pre-f/u versus pre-baseline), and group by time interaction. Two-sided alpha = .05 level tests were used. The hypothesis that the proportion with ER visits would decrease in the Living Well group versus the control group was tests by test of the interaction term.||||.64
72482759|NCT01676909|144492386|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||The same mixed model used for testing hypothesis 1 was used to test treatment effects on secondary scale outcomes (Hypothesis 3: health-related self-efficacy, patient activation; Hypothesis 4: six subscales of the Measure of Self-Management Behaviors) and several other pre-specified outcomes. To test for a group difference in mean change from baseline to follow-up (hypothesis 5) on all primary and secondary outcomes, the significance test of the group-by-follow-up coefficient was performed.||||<.0001
72482760|NCT01676909|144492387|SUPERIORITY|||||||0.038|||||||Mixed Models Analysis|||The same mixed model used for testing hypothesis 1 was used to test treatment effects on secondary scale outcomes (Hypothesis 3: health-related self-efficacy, patient activation; Hypothesis 4: six subscales of the Measure of Self-Management Behaviors) and several other pre-specified outcomes. To test for a group difference in mean change from baseline to follow-up (hypothesis 5) on all primary and secondary outcomes, the significance test of the group-by-follow-up coefficient was performed.||||0.038
72482761|NCT01676909|144492388|SUPERIORITY|||||||0.544|||||||Mixed Models Analysis|||The same mixed model used for testing hypothesis 1 was used to test treatment effects on secondary scale outcomes (Hypothesis 3: health-related self-efficacy, patient activation; Hypothesis 4: six subscales of the Measure of Self-Management Behaviors) and several other pre-specified outcomes. To test for a group difference in mean change from baseline to follow-up (hypothesis 5) on all primary and secondary outcomes, the significance test of the group-by-follow-up coefficient was performed.||||0.544
72482762|NCT01676909|144492389|SUPERIORITY|||||||0.699|||||||Mixed Models Analysis|||The same mixed model used for testing hypothesis 1 was used to test treatment effects on secondary scale outcomes (Hypothesis 3: health-related self-efficacy, patient activation; Hypothesis 4: six subscales of the Measure of Self-Management Behaviors) and several other pre-specified outcomes. To test for a group difference in mean change from baseline to follow-up (hypothesis 5) on all primary and secondary outcomes, the significance test of the group-by-follow-up coefficient was performed.||||0.699
72511388|NCT03342469|144553240|OTHER||||||>|0.05|||||||repeated measures General Linear Model|||"Difference in Theta Power in control group with and without exposure to AFC. General linear model assessed the impact of treatment (AFC v. placebo) on each EEG frequency band, taking into account order of materials. Dependent variable = Treatment (EEG power during AFC, EEG power during placebo); independent variable = order (AFC/placebo, placebo/AFC)~This is a pilot study, thus a power calculation was not done and it was not power to correct for multiple comparisons"||||>0.05
72511389|NCT03342469|144553240|OTHER||||||>|0.05||||||Significance level \</= 0.05. This was chosen due to the small sample size. The p-value is not adjusted for multiple comparisons as this was a pilot study and a power analysis for sample size was not conducted.|repeated measures General Linear Model|||"Difference in Alpha Power in control group with and without exposure to AFC. General linear model assessed the impact of treatment (AFC v. placebo) on each EEG frequency band, taking into account order of materials. Dependent variable = Treatment (EEG power during AFC, EEG power during placebo); independent variable = order (AFC/placebo, placebo/AFC)~This is a pilot study, thus a power calculation was not done and it was not power to correct for multiple comparisons."||||>0.05
72511390|NCT03342469|144553240|OTHER||||||>|0.05||||||Significance level \</= 0.05. This was chosen due to the small sample size. The p-value is not adjusted for multiple comparisons as this was a pilot study and a power analysis for sample size was not conducted.|repeated measures General Linear Model|||"Difference in Beta Power in control group with and without exposure to AFC. General linear model assessed the impact of treatment (AFC v. placebo) on each EEG frequency band, taking into account order of materials. Dependent variable = Treatment (EEG power during AFC, EEG power during placebo); independent variable = order (AFC/placebo, placebo/AFC)~This is a pilot study, thus a power calculation was not done and it was not power to correct for multiple comparisons."||||>0.05
72511391|NCT03342469|144553240|OTHER||||||>|0.05||||||Significance level \</= 0.05. This was chosen due to the small sample size. The p-value is not adjusted for multiple comparisons as this was a pilot study and a power analysis for sample size was not conducted.|repeated measures General Linear Model|||"Difference in Gamma Power in control group with and without exposure to AFC. General linear model assessed the impact of treatment (AFC v. placebo) on each EEG frequency band, taking into account order of materials. Dependent variable = Treatment (EEG power during AFC, EEG power during placebo); independent variable = order (AFC/placebo, placebo/AFC)~This is a pilot study, thus a power calculation was not done and it was not power to correct for multiple comparisons."||||>0.05
72511392|NCT03342469|144553241|OTHER||||||>|0.05||||||Significance level \</= 0.05. This was chosen due to the small sample size. The p-value is not adjusted for multiple comparisons as this was a pilot study and a power analysis for sample size was not conducted.|repeated measures General Linear Model|F(1,15) = 3.65, p = 0.08||"Difference in inattentive ASRS in ADHD group with/without exposure to AFC. General linear model assessed the impact of treatment (AFC v. placebo) on each EEG frequency band, taking into account order of materials. Dependent variable = Treatment (inattentive ASRS score during AFC, inattentive ASRS score during placebo); independent variable = order (AFC/placebo, placebo/AFC)~This is a pilot study, thus a power calculation was not done and it was not power to correct for multiple comparisons."||||>0.05
72542468|NCT00106028|144614687|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.66||||0.4978|TWO_SIDED|95.0|-6.499|3.179|||ANCOVA|LS means and p-value are from ANCOVA model adjusted by baseline and fixed effects for age group, treatment and pooled center for post-baseline.||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.||3.179|-6.499|0.4978
72482763|NCT01676909|144492390|SUPERIORITY|||||||0.006|||||||Mixed Models Analysis|||The same mixed model used for testing hypothesis 1 was used to test treatment effects on secondary scale outcomes (Hypothesis 3: health-related self-efficacy, patient activation; Hypothesis 4: six subscales of the Measure of Self-Management Behaviors) and several other pre-specified outcomes. To test for a group difference in mean change from baseline to follow-up (hypothesis 5) on all primary and secondary outcomes, the significance test of the group-by-follow-up coefficient was performed.||||0.006
72482764|NCT01676909|144492391|SUPERIORITY|||||||0.762|||||||Mixed Models Analysis|||The same mixed model used for testing hypothesis 1 was used to test treatment effects on secondary scale outcomes (Hypothesis 3: health-related self-efficacy, patient activation; Hypothesis 4: six subscales of the Measure of Self-Management Behaviors) and several other pre-specified outcomes. To test for a group difference in mean change from baseline to follow-up (hypothesis 5) on all primary and secondary outcomes, the significance test of the group-by-follow-up coefficient was performed.||||0.762
72482765|NCT01676909|144492392|SUPERIORITY|||||||0.326|||||||Mixed Models Analysis|||The same mixed model used for testing hypothesis 1 was used to test treatment effects on secondary scale outcomes (Hypothesis 3: health-related self-efficacy, patient activation; Hypothesis 4: six subscales of the Measure of Self-Management Behaviors) and several other pre-specified outcomes. To test for a group difference in mean change from baseline to follow-up (hypothesis 5) on all primary and secondary outcomes, the significance test of the group-by-follow-up coefficient was performed.||||0.326
72482766|NCT01676909|144492393|SUPERIORITY|||||||0.667|||||||Mixed Models Analysis|||The same mixed model used for testing hypothesis 1 was used to test treatment effects on secondary scale outcomes (Hypothesis 3: health-related self-efficacy, patient activation; Hypothesis 4: six subscales of the Measure of Self-Management Behaviors) and several other pre-specified outcomes. To test for a group difference in mean change from baseline to follow-up (hypothesis 5) on all primary and secondary outcomes, the significance test of the group-by-follow-up coefficient was performed.||||0.667
72482767|NCT01676909|144492394|SUPERIORITY|||||||0.142|||||||Mixed Models Analysis|||The same mixed model used for testing hypothesis 1 was used to test treatment effects on secondary scale outcomes (Hypothesis 3: health-related self-efficacy, patient activation; Hypothesis 4: six subscales of the Measure of Self-Management Behaviors) and several other pre-specified outcomes. To test for a group difference in mean change from baseline to follow-up (hypothesis 5) on all primary and secondary outcomes, the significance test of the group-by-follow-up coefficient was performed.||||0.142
72482768|NCT01676909|144492395|SUPERIORITY|||||||0.342|||||||Mixed Models Analysis|||The same mixed model used for testing hypothesis 1 was used to test treatment effects on secondary scale outcomes (Hypothesis 3: health-related self-efficacy, patient activation; Hypothesis 4: six subscales of the Measure of Self-Management Behaviors) and several other pre-specified outcomes. To test for a group difference in mean change from baseline to follow-up (hypothesis 5) on all primary and secondary outcomes, the significance test of the group-by-follow-up coefficient was performed.||||0.342
72482769|NCT01676909|144492396|SUPERIORITY|||||||0.563|||||||Mixed Models Analysis|||The same mixed model used for testing hypothesis 1 was used to test treatment effects on secondary scale outcomes (Hypothesis 3: health-related self-efficacy, patient activation; Hypothesis 4: six subscales of the Measure of Self-Management Behaviors) and several other pre-specified outcomes. To test for a group difference in mean change from baseline to follow-up (hypothesis 5) on all primary and secondary outcomes, the significance test of the group-by-follow-up coefficient was performed.||||0.563
72482770|NCT01676909|144492397|SUPERIORITY|||||||0.004|||||||Mixed Models Analysis|||The same mixed model used for testing hypothesis 1 was used to test treatment effects on secondary scale outcomes (Hypothesis 3: health-related self-efficacy, patient activation; Hypothesis 4: six subscales of the Measure of Self-Management Behaviors) and several other pre-specified outcomes. To test for a group difference in mean change from baseline to follow-up (hypothesis 5) on all primary and secondary outcomes, the significance test of the group-by-follow-up coefficient was performed.||||0.004
72482771|NCT01676909|144492398|SUPERIORITY|||||||0.727|||||||Mixed Models Analysis|||The same mixed model used for testing hypothesis 1 was used to test treatment effects on secondary scale outcomes (Hypothesis 3: health-related self-efficacy, patient activation; Hypothesis 4: six subscales of the Measure of Self-Management Behaviors) and several other pre-specified outcomes. To test for a group difference in mean change from baseline to follow-up (hypothesis 5) on all primary and secondary outcomes, the significance test of the group-by-follow-up coefficient was performed.||||0.727
72482772|NCT01676909|144492399|SUPERIORITY|||||||0.446|||||||Mixed Models Analysis|||The same mixed model used for testing hypothesis 1 was used to test treatment effects on secondary scale outcomes (Hypothesis 3: health-related self-efficacy, patient activation; Hypothesis 4: six subscales of the Measure of Self-Management Behaviors) and several other pre-specified outcomes. To test for a group difference in mean change from baseline to follow-up (hypothesis 5) on all primary and secondary outcomes, the significance test of the group-by-follow-up coefficient was performed.||||0.446
72482773|NCT01676909|144492400|SUPERIORITY|||||||0.459|||||||Mixed Models Analysis|||The same mixed model used for testing hypothesis 1 was used to test treatment effects on secondary scale outcomes (Hypothesis 3: health-related self-efficacy, patient activation; Hypothesis 4: six subscales of the Measure of Self-Management Behaviors) and several other pre-specified outcomes. To test for a group difference in mean change from baseline to follow-up (hypothesis 5) on all primary and secondary outcomes, the significance test of the group-by-follow-up coefficient was performed.||||0.459
72482774|NCT01676909|144492401|SUPERIORITY|||||||0.038|||||||Mixed Models Analysis|||The same mixed model used for testing hypothesis 1 was used to test treatment effects on secondary scale outcomes (Hypothesis 3: health-related self-efficacy, patient activation; Hypothesis 4: six subscales of the Measure of Self-Management Behaviors) and several other pre-specified outcomes. To test for a group difference in mean change from baseline to follow-up (hypothesis 5) on all primary and secondary outcomes, the significance test of the group-by-follow-up coefficient was performed.||||0.038
72567130|NCT01172821|144665189|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.083|STANDARD_ERROR_OF_MEAN|0.059||0.1602|TWO_SIDED|95.0|-0.198|0.033|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||0.033|-0.198|0.1602
72482775|NCT01676909|144492402|SUPERIORITY|||||||0.238|||||||Mixed Models Analysis|||The same mixed model used for testing hypothesis 1 was used to test treatment effects on secondary scale outcomes (Hypothesis 3: health-related self-efficacy, patient activation; Hypothesis 4: six subscales of the Measure of Self-Management Behaviors) and several other pre-specified outcomes. To test for a group difference in mean change from baseline to follow-up (hypothesis 5) on all primary and secondary outcomes, the significance test of the group-by-follow-up coefficient was performed.||||0.238
72482776|NCT01676909|144492403|SUPERIORITY|||||||0.011|||||||Mixed Models Analysis|||The same mixed model used for testing hypothesis 1 was used to test treatment effects on secondary scale outcomes (Hypothesis 3: health-related self-efficacy, patient activation; Hypothesis 4: six subscales of the Measure of Self-Management Behaviors) and several other pre-specified outcomes. To test for a group difference in mean change from baseline to follow-up (hypothesis 5) on all primary and secondary outcomes, the significance test of the group-by-follow-up coefficient was performed.||||0.011
72482777|NCT01676909|144492404|SUPERIORITY|||||||0.709|||||||Mixed Models Analysis|||The same mixed model used for testing hypothesis 1 was used to test treatment effects on secondary scale outcomes (Hypothesis 3: health-related self-efficacy, patient activation; Hypothesis 4: six subscales of the Measure of Self-Management Behaviors) and several other pre-specified outcomes. To test for a group difference in mean change from baseline to follow-up (hypothesis 5) on all primary and secondary outcomes, the significance test of the group-by-follow-up coefficient was performed.||||0.709
72482778|NCT01676909|144492405|SUPERIORITY|||||||0.134|||||||Mixed Models Analysis|||The same mixed model used for testing hypothesis 1 was used to test treatment effects on secondary scale outcomes (Hypothesis 3: health-related self-efficacy, patient activation; Hypothesis 4: six subscales of the Measure of Self-Management Behaviors) and several other pre-specified outcomes. To test for a group difference in mean change from baseline to follow-up (hypothesis 5) on all primary and secondary outcomes, the significance test of the group-by-follow-up coefficient was performed.||||0.134
72482779|NCT01676909|144492406|SUPERIORITY|||||||0.045|||||||Mixed Models Analysis|||The same mixed model used for testing hypothesis 1 was used to test treatment effects on secondary scale outcomes (Hypothesis 3: health-related self-efficacy, patient activation; Hypothesis 4: six subscales of the Measure of Self-Management Behaviors) and several other pre-specified outcomes. To test for a group difference in mean change from baseline to follow-up (hypothesis 5) on all primary and secondary outcomes, the significance test of the group-by-follow-up coefficient was performed.||||0.045
72482780|NCT01676909|144492407|SUPERIORITY|||||||0.099|||||||Mixed Models Analysis|||The same mixed model used for testing hypothesis 1 was used to test treatment effects on secondary scale outcomes (Hypothesis 3: health-related self-efficacy, patient activation; Hypothesis 4: six subscales of the Measure of Self-Management Behaviors) and several other pre-specified outcomes. To test for a group difference in mean change from baseline to follow-up (hypothesis 5) on all primary and secondary outcomes, the significance test of the group-by-follow-up coefficient was performed.||||0.099
72482781|NCT01676909|144492408|SUPERIORITY|||||||0.852|||||||Mixed Models Analysis|||The same mixed model used for testing hypothesis 1 was used to test treatment effects on secondary scale outcomes (Hypothesis 3: health-related self-efficacy, patient activation; Hypothesis 4: six subscales of the Measure of Self-Management Behaviors) and several other pre-specified outcomes. To test for a group difference in mean change from baseline to follow-up (hypothesis 5) on all primary and secondary outcomes, the significance test of the group-by-follow-up coefficient was performed.||||0.852
72482782|NCT01676909|144492409|SUPERIORITY|||||||0.285|||||||Mixed Models Analysis|||The same mixed model used for testing hypothesis 1 was used to test treatment effects on secondary scale outcomes (Hypothesis 3: health-related self-efficacy, patient activation; Hypothesis 4: six subscales of the Measure of Self-Management Behaviors) and several other pre-specified outcomes. To test for a group difference in mean change from baseline to follow-up (hypothesis 5) on all primary and secondary outcomes, the significance test of the group-by-follow-up coefficient was performed.||||0.285
72482783|NCT01676909|144492410|SUPERIORITY|||||||0.222|||||||Mixed Models Analysis|||The same mixed model used for testing hypothesis 1 was used to test treatment effects on secondary scale outcomes (Hypothesis 3: health-related self-efficacy, patient activation; Hypothesis 4: six subscales of the Measure of Self-Management Behaviors) and several other pre-specified outcomes. To test for a group difference in mean change from baseline to follow-up (hypothesis 5) on all primary and secondary outcomes, the significance test of the group-by-follow-up coefficient was performed.||||0.222
72511393|NCT03342469|144553241|OTHER||||||>|0.05||||||Significance level \</= 0.05. This was chosen due to the small sample size. The p-value is not adjusted for multiple comparisons as this was a pilot study and a power analysis for sample size was not conducted.|repeated measures General Linear Model|||"Difference in hyperactive ASRS in ADHD group with/without exposure to AFC. General linear model assessed the impact of treatment (AFC v. placebo) on each EEG frequency band, taking into account order of materials. Dependent variable = Treatment (hyperactive ASRS score during AFC, hyperactive ASRS score during placebo); independent variable = order (AFC/placebo, placebo/AFC)~This is a pilot study, thus a power calculation was not done and it was not power to correct for multiple comparisons."||||>0.05
72567131|NCT01172821|144665190|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.19||||0.4012|TWO_SIDED|95.0|0.81|1.74||Calculated as 2\*one-sided-p-value in the direction corresponding to testing the null hypothesis|Fisher Exact||Tio R2.5 / Placebo|||1.74|0.81|0.4012
72567132|NCT01172821|144665190|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.98||||1.1727|TWO_SIDED|95.0|0.67|1.42||Calculated as 2\*one-sided-p-value in the direction corresponding to testing the null hypothesis|Fisher Exact||Tio R5 / Placebo|||1.42|0.67|1.1727
72567133|NCT01172821|144665191|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|20.613|STANDARD_ERROR_OF_MEAN|4.496|<|0.0001|TWO_SIDED|95.0|11.795|29.431|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R2.5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||29.431|11.795|<0.0001
72567134|NCT01172821|144665191|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|24.757|STANDARD_ERROR_OF_MEAN|4.513|<|0.0001|TWO_SIDED|95.0|15.907|33.607|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||33.607|15.907|<0.0001
72567135|NCT01172821|144665192|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|15.991|STANDARD_ERROR_OF_MEAN|4.547||0.0004|TWO_SIDED|95.0|7.074|24.908|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R2.5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||24.908|7.074|0.0004
72482784|NCT02175004|144492432|SUPERIORITY||Least Squares Mean Difference|-17.84|||<|0.001|TWO_SIDED|95.0|-26.12|-9.56||P-value= MMRM with fixed categorical effects for treatment, time, treatment-by-time interaction, each of 3 randomization stratification factors, fixed covariates for parent study baseline value, baseline-by-time interaction.|MMRM|||Change From Baseline in the mNIS+7 Composite Score at Week 78||-9.56|-26.12|<0.001
72482785|NCT02175004|144492432|SUPERIORITY||Least Squares Mean Difference|-20.11|||<|0.001|TWO_SIDED|95.0|-31.27|-8.95||P-value= MMRM with fixed categorical effects for treatment, time, treatment-by-time interaction, each of 3 randomization stratification factors, fixed covariates for parent study baseline value, baseline-by-time interaction.|MMRM|||Change From Baseline in the mNIS+7 Composite Score at Week 156||-8.95|-31.27|<0.001
72482786|NCT02175004|144492433|SUPERIORITY||Least Squares Mean Difference|-0.06||||0.638|TWO_SIDED|95.0|-0.32|0.2||P-value=MMRM with fixed categorical effects for treatment, time, treatment-by-time interaction, each of 3 randomization stratification factors, fixed covariates for parent study baseline value, baseline-by-time interaction.|MMRM|||Change From Baseline in the mNIS +7 Component: Heart Rate to Deep Breathing Score at Week 78||0.20|-0.32|0.638
72482787|NCT02175004|144492433|SUPERIORITY||Least Squares Mean Difference|-0.01||||0.965|TWO_SIDED|95.0|-0.3|0.29||P-value= MMRM with fixed categorical effects for treatment, time, treatment-by-time interaction, each of 3 randomization stratification factors, fixed covariates for parent study baseline value, baseline-by-time interaction.|MMRM|||Change From Baseline in the mNIS +7 Component: Heart Rate to Deep Breathing Score at Week 156||0.29|-0.30|0.965
72482788|NCT02175004|144492434|SUPERIORITY||Least Squares Mean Difference|-1.09|||<|0.001|TWO_SIDED|95.0|-1.68|-0.5||P-value= MMRM with fixed categorical effects for treatment, time, treatment-by-time interaction, each of 3 randomization stratification factors, fixed covariates for parent study baseline value, baseline-by-time interaction.|MMRM|||Change From Baseline in the mNIS +7 Component: Nerve Conduction Score at Week 78||-0.50|-1.68|<0.001
72482789|NCT02175004|144492434|SUPERIORITY||Least Squares Mean Difference|-0.66||||0.067|TWO_SIDED|95.0|-1.38|0.05||P-value= MMRM with fixed categorical effects for treatment, time, treatment-by-time interaction, each of 3 randomization stratification factors, fixed covariates for parent study baseline value, baseline-by-time interaction.|MMRM|||Change From Baseline in the mNIS +7 Component: Nerve Conduction Score at Week 156||0.05|-1.38|0.067
72567136|NCT01172821|144665192|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|21.247|STANDARD_ERROR_OF_MEAN|4.561|<|0.0001|TWO_SIDED|95.0|12.302|30.193|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||30.193|12.302|<0.0001
72567137|NCT01172821|144665193|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.953|STANDARD_ERROR_OF_MEAN|0.598||0.1114|TWO_SIDED|95.0|-2.125|0.22|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R2.5 - Placebo|Analyses included the fixed, categorical effects of treatment, country, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||0.220|-2.125|0.1114
72567138|NCT01172821|144665193|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.178|STANDARD_ERROR_OF_MEAN|0.6||0.7665|TWO_SIDED|95.0|-1.355|0.999|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R5 - Placebo|Analyses included the fixed, categorical effects of treatment, country, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||0.999|-1.355|0.7665
72624051|NCT05852340|144778447|OTHER|Analysis done using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Ratio (Test/Reference) and 90% CI are expressed as percentages.|Ratio (%) of Adjusted Geometric Means|93.91|||||TWO_SIDED|90.0|81.3|108.48||||||Reference: Ritlecitinib 30 mg Capsule (Fasted) Test: Ritlecitinib 30 mg Capsule Mixed with Applesauce (Fasted)||108.48|81.30|
72624052|NCT05852340|144778447|OTHER|Analysis done using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Ratio (Test/Reference) and 90% CI are expressed as percentages.|Ratio (%) of Adjusted Geometric Means|43.83|||||TWO_SIDED|90.0|37.5|51.23||||||Reference: Ritlecitinib 30 mg Capsule (Fasted) Test: Ritlecitinib 30 mg Capsule Given with High Fat Meal||51.23|37.50|
72482790|NCT02175004|144492435|SUPERIORITY||Least Squares Mean Difference|0.34||||0.821|TWO_SIDED|95.0|-2.67|3.36||P-value= MMRM with fixed categorical effects for treatment, time, treatment-by-time interaction, each of 3 randomization stratification factors, fixed covariates for parent study baseline value, baseline-by-time interaction.|MMRM|||Change From Baseline in the mNIS +7 Component: Heat-Pain Sensory Score at Week 78||3.36|-2.67|0.821
72511394|NCT03342469|144553241|OTHER||||||>|0.05||||||Significance level \</= 0.05. This was chosen due to the small sample size. The p-value is not adjusted for multiple comparisons as this was a pilot study and a power analysis for sample size was not conducted.|repeated measures General Linear Model|||"Difference in total ASRS in ADHD group with/without exposure to AFC. General linear model assessed the impact of treatment (AFC v. placebo) on each EEG frequency band, taking into account order of materials. Dependent variable = Treatment (total ASRS score during AFC, total ASRS score during placebo); independent variable = order (AFC/placebo, placebo/AFC)~This is a pilot study, thus a power calculation was not done and it was not power to correct for multiple comparisons."||||>0.05
72567139|NCT01172821|144665194|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.079|STANDARD_ERROR_OF_MEAN|0.031||0.0111|TWO_SIDED|95.0|0.018|0.14|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R2.5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||0.140|0.018|0.0111
72482791|NCT02175004|144492435|SUPERIORITY||Least Squares Mean Difference|-2.16||||0.293|TWO_SIDED|95.0|-6.21|1.9||P-value= MMRM with fixed categorical effects for treatment, time, treatment-by-time interaction, each of 3 randomization stratification factors, fixed covariates for parent study baseline value, baseline-by-time interaction.|MMRM|||Change From Baseline in the mNIS +7 Component: Heat-Pain Sensory Score at Week 156||1.90|-6.21|0.293
72482792|NCT02175004|144492436|SUPERIORITY||Least Squares Mean Difference|-2.78||||0.047|TWO_SIDED|95.0|-5.53|-0.03||P-value= MMRM with fixed categorical effects for treatment, time, treatment-by-time interaction, each of 3 randomization stratification factors, fixed covariates for parent study baseline value, baseline-by-time interaction.|MMRM|||Change From Baseline in the mNIS +7 Component: Touch-Pressure Sensory Score at Week 78||-0.03|-5.53|0.047
72482793|NCT02175004|144492436|SUPERIORITY||Least Squares Mean Difference|-3.07||||0.041|TWO_SIDED|95.0|-6.0|-0.13||P-value= MMRM with fixed categorical effects for treatment, time, treatment-by-time interaction, each of 3 randomization stratification factors, fixed covariates for parent study baseline value, baseline-by-time interaction.|MMRM|||Change From Baseline in the mNIS +7 Component: Touch-Pressure Sensory Score at Week 156||-0.13|-6.00|0.041
72482794|NCT02175004|144492437|OTHER||Least Squares Mean Difference|-17.48|||<|0.001|TWO_SIDED|95.0|-26.92|-8.03||P-value= MMRM with fixed categorical effects for treatment, time, treatment-by-time interaction, each of 3 randomization stratification factors, fixed covariates for parent study baseline value, baseline-by-time interaction.|MMRM|||Change From Baseline in the NIS Composite Score at Week 52 of Year 4||-8.03|-26.92|<0.001
72482795|NCT02175004|144492438|SUPERIORITY||Least Squares Mean Difference|-0.01||||0.941|TWO_SIDED|95.0|-0.19|0.17||P-value= MMRM with fixed categorical effects for treatment, time, treatment-by-time interaction, each of 3 randomization stratification factors, fixed covariates for parent study baseline value, baseline-by-time interaction.|MMRM|||Change from Baseline in the NIS Component: Cranial Nerves Score Score at Week 52 of Year 4||0.17|-0.19|0.941
72567140|NCT01172821|144665194|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.064|STANDARD_ERROR_OF_MEAN|0.031||0.0395|TWO_SIDED|95.0|0.003|0.126|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||0.126|0.003|0.0395
72567141|NCT01172821|144665195|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.068|STANDARD_ERROR_OF_MEAN|0.032||0.0357|TWO_SIDED|95.0|0.005|0.131|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R2.5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||0.131|0.005|0.0357
72567142|NCT01172821|144665195|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.066|STANDARD_ERROR_OF_MEAN|0.032||0.0422|TWO_SIDED|95.0|0.002|0.129|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||0.129|0.002|0.0422
72482796|NCT02175004|144492439|SUPERIORITY||Least Squares Mean Difference|-9.56||||0.011|TWO_SIDED|95.0|-16.97|-2.16||P-value= MMRM with fixed categorical effects for treatment, time, treatment-by-time interaction, each of 3 randomization stratification factors, fixed covariates for parent study baseline value, baseline-by-time interaction.|MMRM|||Change from Baseline in the NIS Component: Muscle Weakness Score at Week 52 of Years 4||-2.16|-16.97|0.011
72482797|NCT02175004|144492440|SUPERIORITY||Least Squares Mean Difference|-1.05||||0.356|TWO_SIDED|95.0|-3.28|1.18||P-value= MMRM with fixed categorical effects for treatment, time, treatment-by-time interaction, each of 3 randomization stratification factors, fixed covariates for parent study baseline value, baseline-by-time interaction.|MMRM|||Change from Baseline in the NIS Component: Reflexes Score at Week 52 of Years 4||1.18|-3.28|0.356
72482798|NCT02175004|144492441|SUPERIORITY||Least Squares Mean Difference|-5.38|||<|0.001|TWO_SIDED|95.0|-8.58|-2.19||P-value= MMRM with fixed categorical effects for treatment, time, treatment-by-time interaction, each of 3 randomization stratification factors, fixed covariates for parent study baseline value, baseline-by-time interaction.|MMRM|||Change from Baseline in the NIS Component: Sensory Score at Week 52 of Years 4||-2.19|-8.58|<0.001
72567143|NCT01172821|144665196|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.171|STANDARD_ERROR_OF_MEAN|0.131||0.1927|TWO_SIDED|95.0|-0.427|0.086|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R2.5 - Placebo|Analyses included the fixed, categorical effects of treatment, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||0.086|-0.427|0.1927
72567144|NCT01172821|144665196|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.109|STANDARD_ERROR_OF_MEAN|0.131||0.4053|TWO_SIDED|95.0|-0.148|0.367|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R5 - Placebo|Analyses included the fixed, categorical effects of treatment, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||0.367|-0.148|0.4053
72567145|NCT01172821|144665197|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.026|STANDARD_ERROR_OF_MEAN|0.027||0.3501|TWO_SIDED|95.0|-0.079|0.028|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R2.5 - Placebo|Analyses included the fixed, categorical effects of treatment, country, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||0.028|-0.079|0.3501
72567146|NCT01172821|144665197|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.007|STANDARD_ERROR_OF_MEAN|0.028||0.8045|TWO_SIDED|95.0|-0.047|0.061|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R5 - Placebo|Analyses included the fixed, categorical effects of treatment, country, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||0.061|-0.047|0.8045
72567147|NCT01172821|144665198|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.33||||0.0308|TWO_SIDED|95.0|1.03|1.72||Calculated as 2\*one-sided-p-value in the direction corresponding to testing the null hypothesis|Fisher Exact||Tio R2.5 / Placebo|||1.72|1.03|0.0308
72567148|NCT01172821|144665198|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.32||||0.0348|TWO_SIDED|95.0|1.02|1.71||Calculated as 2\*one-sided-p-value in the direction corresponding to testing the null hypothesis|Fisher Exact||Tio R5 / Placebo|||1.71|1.02|0.0348
72567149|NCT00710749|144665201|SUPERIORITY_OR_OTHER_LEGACY|||||||0.44||95.0|||||Wilcoxon signed rank test|||||||0.44
72567150|NCT00710749|144665201|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0001||95.0|||||Wilcoxon signed rank test|||||||0.0001
72567151|NCT00710749|144665201|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||Wilcoxon signed rank test|||||||<0.0001
72482799|NCT02175004|144492442|SUPERIORITY||Least Squares Mean Difference|-9.31||||0.026|TWO_SIDED|95.0|-17.48|-1.14||P-value= MMRM with fixed categorical effects for treatment, time, treatment-by-time interaction, each of 3 randomization stratification factors, fixed covariates for parent study baseline value, baseline-by-time interaction.|MMRM|||Change From Baseline in the Norfolk QOL-DN Questionnaire Total Score at Week 78||-1.14|-17.48|0.026
72567152|NCT04495283|144665221|SUPERIORITY||LS Mean Difference|-114.43|STANDARD_ERROR_OF_MEAN|26.65|<|0.001|ONE_SIDED|90.0||-80.01|||ANOVA|||||-80.01||<0.001
72567153|NCT04495283|144665222|SUPERIORITY||LS Mean Difference|-70.16|STANDARD_ERROR_OF_MEAN|21.549|<|0.001|ONE_SIDED|90.0||-42.32|||ANOVA|||||-42.32||<0.001
72567154|NCT00380692|144665260|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-6.7|STANDARD_ERROR_OF_MEAN|1.7|<|0.001||95.0|-10.0|-3.4||P-value for treatment group differences over time.|Mixed Models Analysis|||||-3.4|-10.0|<0.001
72567155|NCT00380692|144665261|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|0.2||0.921||95.0|-0.5|0.4||P-value for treatment differences over time.|Mixed Models Analysis|||||0.4|-0.5|0.921
72567156|NCT00380692|144665262|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.6|STANDARD_ERROR_OF_MEAN|0.61||0.369||95.0|-1.8|0.7||P-value for treatment differences in Oppositional Score at 8 weeks.|ANCOVA|||||0.7|-1.8|0.369
72567157|NCT00380692|144665262|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.0|STANDARD_ERROR_OF_MEAN|0.87||0.024||95.0|-3.7|-0.3||P-value for treatment differences in Hyperactivity score at 8 weeks|ANCOVA|||||-0.3|-3.7|0.024
72567158|NCT00380692|144665262|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.7|STANDARD_ERROR_OF_MEAN|0.51||0.179||95.0|-1.7|0.3||P-value for treatment differences in Cognititve/Attention score at 8 weeks.|ANCOVA|||||0.3|-1.7|0.179
72567159|NCT00380692|144665262|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.7|STANDARD_ERROR_OF_MEAN|1.48||0.077||95.0|-5.6|0.3||P-value for treatment differences in ADHD score at 8 weeks|ANCOVA|||||0.3|-5.6|0.077
72567160|NCT00380692|144665264|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.5|STANDARD_ERROR_OF_MEAN|0.24||0.028||95.0|-1.0|-0.1||P-value for treatment differences in Time to fall asleep score at 8 weeks.|ANCOVA|||||-0.1|-1.0|0.028
72567161|NCT00380692|144665264|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.3|STANDARD_ERROR_OF_MEAN|0.3||0.407||95.0|-0.3|0.9||P-value for treatment differences in Difficulty falling asleep score at 8 weeks.|ANCOVA|||||0.9|-0.3|0.407
72567162|NCT00380692|144665264|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1|STANDARD_ERROR_OF_MEAN|0.24||0.652||95.0|-0.6|0.4||P-value for treatment differences in Total hours of sleep score at 8 weeks.|ANCOVA|||||0.4|-0.6|0.652
72567163|NCT00380692|144665264|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.8|STANDARD_ERROR_OF_MEAN|0.49||0.112||95.0|-1.7|0.2||P-value for treatment differences in Quality of sleep score at 8 weeks.|ANCOVA|||||0.2|-1.7|0.112
72567164|NCT00380692|144665264|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.1|STANDARD_ERROR_OF_MEAN|0.87||0.188||95.0|-2.9|0.6||P-value for treatment differences in Functional outcome during day score at 8 weeks.|ANCOVA|||||0.6|-2.9|0.188
72567165|NCT00380692|144665265|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.0|STANDARD_ERROR_OF_MEAN|1.29||0.452||95.0|-3.5|1.6||P-value for treatment differences in Irritability score at 8 weeks.|ANCOVA|||||1.6|-3.5|0.452
72567166|NCT00380692|144665265|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.2|STANDARD_ERROR_OF_MEAN|1.1||0.85||95.0|-2.4|2.0||P-value for treatment differences in Lethargy score at 8 weeks.|ANCOVA|||||2.0|-2.4|0.850
72567167|NCT00380692|144665265|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.6|STANDARD_ERROR_OF_MEAN|0.63||0.014||95.0|-2.8|-0.3||P-value for treatment differences in Stereotypic score at 8 weeks.|ANCOVA|||||-0.3|-2.8|0.014
72402203|NCT01480076|144311665|SUPERIORITY_OR_OTHER|||||||0.5405|||||||mixed effect model|||Overall, Non-responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline PCS score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.5405
72402204|NCT01480076|144311665|SUPERIORITY_OR_OTHER||least squares mean|3.7|STANDARD_ERROR_OF_MEAN|0.58|<|0.0001|TWO_SIDED||||||mixed effect model|||Overall, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline PCS score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
72482800|NCT02175004|144492442|SUPERIORITY||Least Squares Mean Difference|-7.4||||0.107|TWO_SIDED|95.0|-16.41|1.62||P-value= MMRM with fixed categorical effects for treatment, time, treatment-by-time interaction, each of 3 randomization stratification factors, fixed covariates for parent study baseline value, baseline-by-time interaction.|MMRM|||Change From Baseline in the Norfolk QOL-DN Questionnaire Total Score at Week 156||1.62|-16.41|0.107
72511395|NCT03342469|144553241|OTHER||||||>|0.05||||||Significance level \</= 0.05. This was chosen due to the small sample size. The p-value is not adjusted for multiple comparisons as this was a pilot study and a power analysis for sample size was not conducted.|repeated measures General Linear Model|||"inattentive ASRS in control group with/without exposure to AFC. General linear model assessed the impact of treatment (AFC v. placebo) on each EEG frequency band, taking into account order of materials. Dependent variable = Treatment (inattentive ASRS score during AFC, inattentive ASRS score during placebo); independent variable = order (AFC/placebo, placebo/AFC)~This is a pilot study, thus a power calculation was not done and it was not power to correct for multiple comparisons."||||>0.05
72567168|NCT00380692|144665265|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.4|STANDARD_ERROR_OF_MEAN|1.68||0.01||95.0|-7.8|-1.1||P-value for treatment differences in Hyperactivity score at 8 weeks.|ANCOVA|||||-1.1|-7.8|0.010
72482801|NCT02175004|144492442|SUPERIORITY||Least Squares Mean Difference|-2.72||||0.669|TWO_SIDED|95.0|-15.22|9.77||P-value= MMRM with fixed categorical effects for treatment, time, treatment-by-time interaction, each of 3 randomization stratification factors, fixed covariates for parent study baseline value, baseline-by-time interaction.|MMRM|||Change From Baseline in the Norfolk QOL-DN Questionnaire Total Score at Week 52 of Year 4||9.77|-15.22|0.669
72482802|NCT02175004|144492443|SUPERIORITY||Least Squares Mean Difference|-6.3||||0.097|TWO_SIDED|95.0|-13.75|1.15||P-value= MMRM with fixed categorical effects for treatment, time, treatment-by-time interaction, each of 3 randomization stratification factors, fixed covariates for parent study baseline value, baseline-by-time interaction.|MMRM|||Change From Baseline in the Norfolk QOL-DN Change From CS2 Baseline in the Norfolk QOL-DN Questionnaire Total Score at Week 78||1.15|-13.75|0.097
72482803|NCT02175004|144492443|SUPERIORITY||Least Squares Mean Difference|-8.89||||0.081|TWO_SIDED|95.0|-18.88|1.11||P-value= MMRM with fixed categorical effects for treatment, time, treatment-by-time interaction, each of 3 randomization stratification factors, fixed covariates for parent study baseline value, baseline-by-time interaction.|MMRM|||Change from Baseline in the Norfolk QoL-DN Physical Functioning/Large Fiber Neuropathy Domain Score at Week 156||1.11|-18.88|0.081
72482804|NCT02175004|144492443|SUPERIORITY||Least Squares Mean Difference|-11.87||||0.171|TWO_SIDED|95.0|-28.89|5.16||P-value= MMRM with fixed categorical effects for treatment, time, treatment-by-time interaction, each of 3 randomization stratification factors, fixed covariates for parent study baseline value, baseline-by-time interaction.|MMRM|||Change From Baseline in the Norfolk QOL-DN Physical Functioning/Large Fiber Neuropathy Domain Score at Week 52 of Year 4||5.16|-28.89|0.171
72482805|NCT00823901|144492452|SUPERIORITY_OR_OTHER|||||||0.15|||||||t-test, 2 sided|||||||0.15
72482806|NCT01376349|144492458|SUPERIORITY_OR_OTHER|||||||0.08|||||||Wilcoxon (Mann-Whitney)|||||||0.08
72482807|NCT01376349|144492458|SUPERIORITY_OR_OTHER|||||||0.48|||||||Wilcoxon (Mann-Whitney)|||||||0.48
72482808|NCT00819286|144492469|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.003|TWO_SIDED|95.0|||||t-test, 2 sided|||3 Month CT Scores (Plates vs Wires)||||0.003
72482809|NCT00819286|144492469|SUPERIORITY_OR_OTHER|||||||0.01||95.0|||||t-test, 2 sided|||6 Month CT Scores (Plates vs Wires)||||0.01
72482810|NCT00819286|144492470|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.93||95.0|||||t-test, 1 sided|||Plates vs Wires||||0.93
72482811|NCT01324323|144492476|SUPERIORITY_OR_OTHER_LEGACY||Ratio of the Geometric Mean (%)|179.3|||||TWO_SIDED|90.0|160.3|200.7|||ANOVA||"Ratio (Romidepsin + rifampin/Romidepsin) and 90% CI of the ratio of geometric means are from an ANOVA model with treatment as fixed effect and subject as random effect on the natural log transformed PK values."|||200.7|160.3|
72482812|NCT01324323|144492477|SUPERIORITY_OR_OTHER_LEGACY||Ratio of the Geometric Mean|178.3|||||TWO_SIDED|90.0|159.4|199.4|||ANOVA||"Ratio (Romidepsin + rifampin/Romidepsin) and 90% CI of the ratio of geometric means are from an ANOVA model with treatment as fixed effect and subject as random effect on the natural log transformed PK values."|||199.4|159.4|
72402205|NCT01480076|144311665|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 3, Responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline PCS score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
72482813|NCT01324323|144492478|SUPERIORITY_OR_OTHER_LEGACY||Ratio of the Geometric Mean|179.6|||||TWO_SIDED|90.0|160.5|201.0|||ANOVA||"Ratio (Romidepsin + rifampin/Romidepsin) and 90% CI of the ratio of geometric means are from an ANOVA model with treatment as fixed effect and subject as random effect on the natural log transformed PK values."|||201.0|160.5|
72482814|NCT01324323|144492479|SUPERIORITY_OR_OTHER_LEGACY||Ratio of the Geometric Mean|159.1|||||TWO_SIDED|90.0|135.8|186.5|||ANOVA||"Ratio (Romidepsin + rifampin/Romidepsin) and 90% CI of the ratio of geometric means are from an ANOVA model with treatment as fixed effect and subject as random effect on the natural log transformed PK values."|||186.5|135.8|
72482815|NCT01324323|144492480|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-0.15||||0.791|TWO_SIDED|90.0|-1.0|1.01|||Wilcoxon signed-rank|||"Note: The median, median difference (romidepsin + rifampin minus romidepsin) and 90% CI of the median difference are from Hodges-Lehmann Estimate. The P-value is from Wilcoxon signed-rank test."||1.01|-1.0|0.7910
72482816|NCT03153137|144492485|SUPERIORITY|For each stage, the p-value from the ANCOVA model including randomized treatment, geographical region, and baseline peak VO2 was used to construct the final adjusted p-value.|Median unbiased estimate and repeated CI|0.62|||=|0.193|TWO_SIDED|99.0|-0.62|1.85||Final adjusted p-value (from weighted inverse normal combination test)|ANCOVA|||Due to adaptive nature of the design, the main analysis was conducted on FAS using the inverse normal combination method with pre-specified weights to combine first and second stage p-values.||1.85|-0.62|= 0.1930
72482817|NCT01821378|144492512|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-3.1||||0.255|TWO_SIDED|95.0|-8.4|2.2|||Mixed Models Analysis|||||2.2|-8.4|0.255
72482818|NCT01821378|144492512|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-10.3|||<|-0.001|TWO_SIDED|95.0|-14.9|-5.7|||Mixed Models Analysis|||||-5.7|-14.9|<-0.001
72482819|NCT01821378|144492513|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-0.2||||0.169|TWO_SIDED|95.0|-0.49|0.09|||Mixed Models Analysis|||||0.09|-0.49|0.169
72482820|NCT01821378|144492513|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-0.57|||<|0.001|TWO_SIDED|95.0|-0.83|-0.32|||Mixed Models Analysis|||||-0.32|-0.83|<0.001
72482821|NCT01821378|144492514|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-0.3||||0.706|TWO_SIDED|95.0|-1.8|1.2|||ANCOVA|||||1.2|-1.8|0.706
72482822|NCT01821378|144492514|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-2.0||||0.003|TWO_SIDED|95.0|-3.3|-0.7|||ANCOVA|||||-0.7|-3.3|0.003
72482823|NCT01821378|144492515|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.5||||0.173|TWO_SIDED|95.0|0.8|2.5|||Regression, Logistic|||||2.5|0.8|0.173
72482824|NCT01821378|144492515|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.2|||<|0.001|TWO_SIDED|95.0|2.0|5.2|||Regression, Logistic|||||5.2|2.0|<0.001
72482825|NCT01821378|144492516|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-7.7||||0.023|TWO_SIDED|95.0|-14.3|-1.1|||Mixed Models Analysis|||||-1.1|-14.3|0.023
72482826|NCT01821378|144492517|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-0.8||||0.464|TWO_SIDED|95.0|-2.9|1.3|||ANCOVA|||||1.3|-2.9|0.464
72482827|NCT01821378|144492517|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-1.8||||0.122|TWO_SIDED|95.0|-4.1|0.5|||ANCOVA|||||0.5|-4.1|0.122
72482828|NCT01821378|144492518|SUPERIORITY_OR_OTHER||Least Square Mean Difference|2.3||||0.258|TWO_SIDED|95.0|-1.7|6.2|||Mixed Models Analysis|||||6.2|-1.7|0.258
72482829|NCT01821378|144492518|SUPERIORITY_OR_OTHER||Slope|6.6|||<|0.001|TWO_SIDED|95.0|3.2|10.1|||Mixed Models Analysis|||||10.1|3.2|<0.001
72482830|NCT01821378|144492519|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-0.35||||0.052|TWO_SIDED|95.0|-0.7|0.0|||Mixed Models Analysis|||||0.00|-0.70|0.052
72482831|NCT01821378|144492520|SUPERIORITY_OR_OTHER||Least Square Mean Difference|0.084||||0.012|TWO_SIDED|95.0|0.018|0.149|||ANCOVA|||||0.149|0.018|0.012
72482832|NCT01821378|144492520|SUPERIORITY_OR_OTHER||Least Square Mean Difference|0.138|||<|0.001|TWO_SIDED|95.0|0.081|0.194|||ANCOVA|||||0.194|0.081|<0.001
72511396|NCT03342469|144553241|OTHER||||||>|0.05||||||Significance level \</= 0.05. This was chosen due to the small sample size. The p-value is not adjusted for multiple comparisons as this was a pilot study and a power analysis for sample size was not conducted.|repeated measures General Linear Model|||"Hyperactive ASRS in control group with/without exposure to AFC. General linear model assessed the impact of treatment (AFC v. placebo) on each EEG frequency band, taking into account order of materials. Dependent variable = Treatment (hyperactive ASRS score during AFC, hyperactive ASRS score during placebo); independent variable = order (AFC/placebo, placebo/AFC)~This is a pilot study, thus a power calculation was not done and it was not power to correct for multiple comparisons."||||>0.05
72511397|NCT03342469|144553241|OTHER||||||>|0.05||||||Significance level \</= 0.05. This was chosen due to the small sample size. The p-value is not adjusted for multiple comparisons as this was a pilot study and a power analysis for sample size was not conducted.|repeated measures General Linear Model|||"Difference in total ASRS in control group with/without exposure to AFC. General linear model assessed the impact of treatment (AFC v. placebo) on each EEG frequency band, taking into account order of materials. Dependent variable = Treatment (total ASRS score during AFC, total ASRS score during placebo); independent variable = order (AFC/placebo, placebo/AFC)~This is a pilot study, thus a power calculation was not done and it was not power to correct for multiple comparisons."||||>0.05
72567169|NCT00380692|144665265|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.9|STANDARD_ERROR_OF_MEAN|0.42||0.045||95.0|-1.7|0.0||P-value for treatment differences in Inappropriate speech score at 8 weeks.|ANCOVA|||||-0.0|-1.7|0.045
72567170|NCT00380692|144665266|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.9|STANDARD_ERROR_OF_MEAN|2.13||0.069||95.0|-8.1|0.3||P-value for treatment differences in Total score at 8 weeks.|ANCOVA|||||0.3|-8.1|0.069
72567171|NCT00380692|144665267|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.3|STANDARD_ERROR_OF_MEAN|0.64||0.598||95.0|-1.6|0.9||P-value for treatment differences in Total score at 8 weeks.|ANCOVA|||||0.9|-1.6|0.598
72567172|NCT00380692|144665268|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-11.2|STANDARD_ERROR_OF_MEAN|11.12||0.318||95.0|-33.3|11.0||P-value for treatment differences in Total score at 8 weeks.|ANCOVA|||||11.0|-33.3|0.318
72567173|NCT00380692|144665269|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.2|STANDARD_ERROR_OF_MEAN|2.7||0.948||95.0|-5.5|5.2||P-value for treatment differences in Error Rate over time.|Mixed Models Analysis|||||5.2|-5.5|0.948
72567174|NCT00380692|144665269|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.9|STANDARD_ERROR_OF_MEAN|3.5||0.399||95.0|-9.7|3.9||P-value for Treatment\*Condition Error Rate irrelevant targets over time.|Mixed Models Analysis|||||3.9|-9.7|0.399
72567175|NCT00380692|144665269|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.7|STANDARD_DEVIATION|3.1||0.57||95.0|-4.3|7.8||P-value for Treatment\*Condition Error Rate relevant nontargets over time.|Mixed Models Analysis|||||7.8|-4.3|0.570
72567176|NCT00380692|144665270|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-61.9|STANDARD_ERROR_OF_MEAN|66.0||0.352||95.0|-193.5|69.8||P-value for Treatment differences in Reaction time over time.|Mixed Models Analysis|||||69.8|-193.5|0.352
72567177|NCT00380692|144665270|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-37.1|STANDARD_ERROR_OF_MEAN|62.3||0.553||95.0|-160.3|86.2||P-value for Treatment\*Condition Mean Reaction Time correct rejections irrelevant target over time.|Mixed Models Analysis|||||86.2|-160.3|0.553
72567178|NCT00380692|144665270|SUPERIORITY_OR_OTHER||Mean Difference (Net)|7.0|STANDARD_ERROR_OF_MEAN|57.7||0.904||95.0|-107.1|121.1||P-value for Treatment\*Condition Mean Reaction Time correct rejections relevant nontarget over time.|Mixed Models Analysis|||||121.1|-107.1|0.904
72482833|NCT01821378|144492521|SUPERIORITY_OR_OTHER||Least Square Mean Difference|0.0||||0.992|TWO_SIDED|95.0|-6.6|6.6|||Mixed Models Analysis|||||6.6|-6.6|0.992
72482834|NCT01821378|144492521|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-7.3||||0.044|TWO_SIDED|95.0|-14.4|-0.2|||Mixed Models Analysis|||||-0.2|-14.4|0.044
72482835|NCT01821378|144492522|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-0.1||||0.578|TWO_SIDED|95.0|-0.45|0.25|||Mixed Models Analysis|||||0.25|-0.45|0.578
72511398|NCT02932475|144553242|SUPERIORITY||Odds Ratio (OR)|0.86|||||TWO_SIDED|95.0|0.63|1.19|||||The odds ratio was calculated and adjusted for study site, timing of diabetes diagnosis, gestational age at randomization stratified at 18 weeks, and baseline maternal BMI.|The sample size gave adequate power over a range of expected primary outcome event rates, with type I error set at 0.044 (reduced from 0.05 for interim analysis), with reasonable power under a conservative scenario assuming that 20% of subjects immediately stopped taking study agent.||1.19|0.63|
72511399|NCT02932475|144553243|SUPERIORITY||Difference in proportions|0.2||||0.4|TWO_SIDED|||||The a priori threshold for statistical significance was \<0.05.|Chi-squared|||||||0.4
72511400|NCT02932475|144553244|SUPERIORITY||Mean Difference (Final Values)|0.04||||0.4|TWO_SIDED|||||The a priori threshold for statistical significance was \<0.05.|t-test, 2 sided||comparison of mean (sd) between groups|||||0.4
72511401|NCT02932475|144553245|SUPERIORITY||Difference in proportions|0.0||||0.6|TWO_SIDED|||||The a priori threshold for statistical significance is \<0.05.|Chi-squared|||||||0.6
72511402|NCT02932475|144553246|SUPERIORITY||Difference in proportions|0.0||||0.08|TWO_SIDED|||||The a priori threshold for statistical significance is \<0.05.|Chi-squared|||||||0.08
72511403|NCT02322320|144553247|SUPERIORITY|||||||0.6||||||The primary analysis involved pairwise comparisons of PFS between the three treatment arms. To control the familywise type I error rate at 0.05, two-sided testing was performed at a Bonferroni-adjusted significance level of 0.0167 = 0.05 / 3.|Log Rank|The log rank test was stratified on risk status at BMT CTN 0702 enrollment (high risk vs. standard risk)||The null hypothesis is that the percentages of participants with PFS at 5 years post-randomization in BMT CTN 0702 are equal for those assigned to Tandem auto transplant and RVD consolidation therapy.||||0.60
72482836|NCT01821378|144492522|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-0.58||||0.003|TWO_SIDED|95.0|-0.96|-0.2|||Mixed Models Analysis|||||-0.20|-0.96|0.003
72482837|NCT02888665|144492524|OTHER||see above|||||||||||see above. target ORR was not met.|||see above. target ORR was not met.|The primary objective of the phase II design compared ORR with historical rates (Judson et al. Lancet Onc., 2014). A 2-stage design with null hypothesis of 15% using a 1-sided 0.05 α level test has 85% power to detect an increase to 35%. This required up to 35 patients. After 2 responses in stage 1 (20 pts), the study moved to stage 2 (15 pts). If 10 responses were seen (29%), this would have ruled out an ORR of 15%. The study was closed when it became clear we would not meet this benchmark.|see above. target ORR was not met.|||
72482838|NCT01372410|144492552|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Day 8 analysis.|Wald Test|||||||<0.0001
72482839|NCT01372410|144492552|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Pooled Day 7 and 8 analysis.|Wald Test|||||||<0.0001
72482840|NCT01372410|144492553|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.113|||<|0.001|TWO_SIDED|95.0|0.058|0.168|||Mixed Models Analysis|||||0.168|0.058|<0.001
72482841|NCT01372410|144492553|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.101|||<|0.001|TWO_SIDED|95.0|0.045|0.158|||Mixed Models Analysis|||||0.158|0.045|<0.001
72482842|NCT01372410|144492553|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.124|||<|0.001|TWO_SIDED|95.0|0.068|0.179|||Mixed Models Analysis|||||0.179|0.068|<0.001
72482843|NCT01372410|144492553|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.183|||<|0.001|TWO_SIDED|95.0|0.127|0.239|||Mixed Models Analysis|||||0.239|0.127|<0.001
72482844|NCT01372410|144492553|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.125|||<|0.001|TWO_SIDED|95.0|0.069|0.182|||Mixed Models Analysis|||||0.182|0.069|<0.001
72482845|NCT01372410|144492553|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.139|||<|0.001|TWO_SIDED|95.0|0.083|0.196|||Mixed Models Analysis|||||0.196|0.083|<0.001
72511404|NCT02322320|144553247|SUPERIORITY|||||||0.35||||||The primary analysis involved pairwise comparisons of PFS between the three treatment arms. To control the familywise type I error rate at 0.05, two-sided testing was performed at a Bonferroni-adjusted significance level of 0.0167 = 0.05 / 3.|Log Rank|The log rank test was stratified on risk status at BMT CTN 0702 enrollment (high risk vs. standard risk)||The null hypothesis is that the percentages of participants with PFS at 5 years post-randomization in BMT CTN 0702 are equal for those assigned to Tandem auto transplant and Lenalidomide maintenance therapy.||||0.35
72511405|NCT02322320|144553247|SUPERIORITY|||||||0.68||||||The primary analysis involved pairwise comparisons of PFS between the three treatment arms. To control the familywise type I error rate at 0.05, two-sided testing was performed at a Bonferroni-adjusted significance level of 0.0167 = 0.05 / 3.|Log Rank|The log rank test was stratified on risk status at BMT CTN 0702 enrollment (high risk vs. standard risk)||The null hypothesis is that the percentages of participants with PFS at 5 years post-randomization in BMT CTN 0702 are equal for those assigned to RVD consolidation and Lenalidomide maintenance therapy.||||0.68
72511406|NCT02322320|144553248|SUPERIORITY|||||||0.57||||||The analysis involved pairwise comparisons of OS between the three treatment arms. To control the familywise type I error rate at 0.05, two-sided testing was performed at a Bonferroni-adjusted significance level of 0.0167 = 0.05 / 3.|Log Rank|The log rank test was stratified on risk status at BMT CTN 0702 enrollment (high risk vs. standard risk)||The null hypothesis is that the percentages of participants with OS at 5 years post-randomization in BMT CTN 0702 are equal for those assigned to Tandem auto transplant and RVD consolidation therapy.||||0.57
72511407|NCT02322320|144553248|SUPERIORITY|||||||0.38||||||The analysis involved pairwise comparisons of OS between the three treatment arms. To control the familywise type I error rate at 0.05, two-sided testing was performed at a Bonferroni-adjusted significance level of 0.0167 = 0.05 / 3.|Log Rank|The log rank test was stratified on risk status at BMT CTN 0702 enrollment (high risk vs. standard risk)||The null hypothesis is that the percentages of participants with OS at 5 years post-randomization in BMT CTN 0702 are equal for those assigned to Tandem auto transplant and Lenalidomide maintenance therapy.||||0.38
72567179|NCT00380692|144665271|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-21.3|STANDARD_ERROR_OF_MEAN|65.9||0.748||95.0|-152.8|110.3||P-value for Treatment differences in Standard Deviation of Reaction Time over time.|Mixed Models Analysis|||||110.3|-152.8|0.748
72402206|NCT01480076|144311665|SUPERIORITY_OR_OTHER|||||||0.7272|||||||mixed effect model|||Month 3, Non-responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline PCS score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.7272
72402207|NCT01480076|144311665|SUPERIORITY_OR_OTHER||least squares mean|4.3|STANDARD_ERROR_OF_MEAN|0.64|<|0.0001|TWO_SIDED||||||mixed effect model|||Month 3, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline PCS score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
72482846|NCT01372410|144492553|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.101|||<|0.001|TWO_SIDED|95.0|0.045|0.157|||Mixed Models Analysis|||||0.157|0.045|<0.001
72482847|NCT04526197|144492637|OTHER|Confidence Interval|Ratio of geometric LS means|0.881|||||TWO_SIDED|90.0|0.776|1.001||||||||1.001|0.776|
72482848|NCT04526197|144492638|OTHER|Confidence Interval|Ratio of geometric LS means|1.016|||||TWO_SIDED|90.0|0.959|1.077||||||||1.077|0.959|
72482849|NCT04526197|144492639|OTHER|Confidence Interval|Ratio of geometric LS means|1.01|||||TWO_SIDED|90.0|0.954|1.07||||||||1.070|0.954|
72482850|NCT02411578|144492647|SUPERIORITY|||||||0.99||||||Proportions of successes in each arm were compared using a generalized linear mixed model with a logistic link function, random participant effect to account for correlated data from some pts having multiple events, and adjustment for baseline BG.|Mixed Models Analysis|||For the crossover trial primary analysis, analyzed events were study treatment events meeting the following criteria: a) a survey was completed in the smart phone application, b) the initial BG measurement was 40 to 69 mg/dL, c) BG measurements were performed at both the 15-minute (in a window of 13 to 20 minutes) and 30-minute (28 to 40 minutes) time points, and d) appropriate treatment including dose was taken both at the initial and 15-minute time points.||||0.99
72482851|NCT02411578|144492648|SUPERIORITY|||||||0.34|||||||Mixed Models Analysis|Analyzed with generalized linear mixed model with an identity link. Due to violations of normality, rank transformations were used in model.||||||0.34
72482852|NCT02411578|144492649|SUPERIORITY|||||||0.01|||||||Mixed Models Analysis|Analyzed with generalized linear mixed model with an identity link. Due to violations of normality, rank transformations were used in model.||||||0.01
72482853|NCT02411578|144492650|SUPERIORITY|||||||0.02|||||||Mixed Models Analysis|Analyzed with generalized linear mixed model with an identity link. Due to violations of normality, rank transformations were used in model.||||||0.02
72482854|NCT02411578|144492651|SUPERIORITY|||||||0.86|||||||Mixed Models Analysis|Analyzed with generalized linear mixed model with an identity link. Due to violations of normality, rank transformations were used in model.||||||0.86
72482855|NCT02411578|144492652|SUPERIORITY|||||||0.95|||||||Mixed Models Analysis|Analyzed with generalized linear mixed model with an identity link. Due to violations of normality, rank transformations were used in model.||||||0.95
72482856|NCT02411578|144492653|SUPERIORITY|||||||0.78|||||||Mixed Models Analysis|Analyzed with generalized linear mixed model with an identity link. Due to violations of normality, rank transformations were used in model.||||||0.78
72482857|NCT02411578|144492654|SUPERIORITY|||||||0.21|||||||Mixed Models Analysis|Analyzed with generalized linear mixed model with an identity link. Due to violations of normality, rank transformations were used in model.||||||0.21
72482858|NCT02411578|144492655|SUPERIORITY|||||||0.09|||||||Mixed Models Analysis|Analyzed with generalized linear mixed model with an identity link. Due to violations of normality, rank transformations were used in model.||||||0.09
72511408|NCT02322320|144553248|SUPERIORITY|||||||0.77||||||The analysis involved pairwise comparisons of OS between the three treatment arms. To control the familywise type I error rate at 0.05, two-sided testing was performed at a Bonferroni-adjusted significance level of 0.0167 = 0.05 / 3.|Log Rank|The log rank test was stratified on risk status at BMT CTN 0702 enrollment (high risk vs. standard risk)||The null hypothesis is that the percentages of participants with OS at 5 years post-randomization in BMT CTN 0702 are equal for those assigned to RVD consolidation and Lenalidomide maintenance therapy.||||0.77
72402208|NCT01480076|144311665|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 6, Responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline PCS score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
72482859|NCT02411578|144492656|SUPERIORITY|||||||0.49|||||||Mixed Models Analysis|Analyzed with generalized linear mixed model with an identity link. Due to violations of normality, rank transformations were used in model.||||||0.49
72482860|NCT02411578|144492657|SUPERIORITY|||||||0.63|||||||Mixed Models Analysis|Analyzed with generalized linear mixed model with an identity link. Due to violations of normality, rank transformations were used in model.||||||0.63
72482861|NCT02411578|144492658|SUPERIORITY|||||||0.41|||||||Mixed Models Analysis|Analyzed with generalized linear mixed model with an identity link. Due to violations of normality, rank transformations were used in model.||||||0.41
72482862|NCT02411578|144492659|SUPERIORITY|||||||0.8|||||||Mixed Models Analysis|Analyzed with generalized linear mixed model with an identity link. Due to violations of normality, rank transformations were used in model.||||||0.80
72482863|NCT02411578|144492660|SUPERIORITY|||||||0.13|||||||Mixed Models Analysis|Analyzed with generalized linear mixed model with an identity link. Due to violations of normality, rank transformations were used in model.||||||0.13
72482864|NCT02411578|144492661|SUPERIORITY|||||||0.7|||||||Mixed Models Analysis|Analyzed with generalized linear mixed model with an identity link. Due to violations of normality, rank transformations were used in model.||||||0.70
72482865|NCT02411578|144492662|SUPERIORITY|||||||0.93||||||Proportions of successes in each arm were compared using a generalized linear mixed model with a logistic link function, random participant effect to account for correlated data from some pts having multiple events, and adjustment for baseline BG.|Mixed Models Analysis|||||||0.93
72402209|NCT01480076|144311665|SUPERIORITY_OR_OTHER|||||||0.7484|||||||mixed effect model|||Month 6, Non-responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline PCS score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.7484
72402210|NCT01480076|144311665|SUPERIORITY_OR_OTHER||least squares mean|3.0|STANDARD_ERROR_OF_MEAN|0.75|<|0.0001|TWO_SIDED||||||mixed effect model|||Month 6, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline PCS score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
72402211|NCT01480076|144311665|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 9, Responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline PCS score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
72402212|NCT01480076|144311665|SUPERIORITY_OR_OTHER|||||||0.1877|||||||mixed effect model|||Month 9, Non-responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline PCS score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.1877
72402213|NCT01480076|144311665|SUPERIORITY_OR_OTHER||least squares mean|4.1|STANDARD_ERROR_OF_MEAN|0.78|<|0.0001|TWO_SIDED||||||mixed effect model|||Month 9, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline PCS score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
72402214|NCT01480076|144311665|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 12, Responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline PCS score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
72482866|NCT02411578|144492663|SUPERIORITY|||||||0.66||||||Proportions of successes in each arm were compared using a generalized linear mixed model with a logistic link function, random participant effect to account for correlated data from some pts having multiple events, and adjustment for baseline BG.|Mixed Models Analysis|||||||0.66
72482867|NCT02411578|144492664|SUPERIORITY|||||||0.08||||||Proportions of successes in each arm were compared using a generalized linear mixed model with a logistic link function, random participant effect to account for correlated data from some pts having multiple events, and adjustment for baseline BG.|Mixed Models Analysis|||||||0.08
72482868|NCT05629962|144492695|SUPERIORITY|||||||0.954|||||||Cochran-Mantel-Haenszel|||||||0.954
72482869|NCT03645954|144492739|SUPERIORITY||||||<|0.01||||||The threshold for statistical significance was p = 0.05.|Chi-squared|||||||<0.01
72511409|NCT02322320|144553249|SUPERIORITY|||||||0.67||||||The analysis involved pairwise comparisons of EFS between the three treatment arms. To control the familywise type I error rate at 0.05, two-sided testing was performed at a Bonferroni-adjusted significance level of 0.0167 = 0.05 / 3.|Log Rank|The log rank test was stratified on risk status at BMT CTN 0702 enrollment (high risk vs. standard risk)||The null hypothesis is that the percentages of participants with EFS at 5 years post-randomization in BMT CTN 0702 are equal for those assigned to Tandem auto transplant and RVD consolidation therapy.||||0.67
72482870|NCT03645954|144492740|SUPERIORITY||||||>|0.05||||||The threshold for statistical significance was p = 0.05.|t-test, 2 sided|||||||>0.05
72482871|NCT03645954|144492741|OTHER||||||>|0.05||||||The threshold for statistical significance was p = 0.05.|t-test, 2 sided|||||||>0.05
72482872|NCT03645954|144492742|OTHER||||||>|0.05||||||The threshold for statistical significance was p = 0.05.|Chi-squared|||||||>0.05
72482873|NCT03645954|144492743|OTHER||||||>|0.05||||||The threshold for statistical significance was p = 0.05.|t-test, 2 sided|||||||>0.05
72511410|NCT02322320|144553249|SUPERIORITY|||||||0.2||||||The analysis involved pairwise comparisons of EFS between the three treatment arms. To control the familywise type I error rate at 0.05, two-sided testing was performed at a Bonferroni-adjusted significance level of 0.0167 = 0.05 / 3.|Log Rank|The log rank test was stratified on risk status at BMT CTN 0702 enrollment (high risk vs. standard risk)||The null hypothesis is that the percentages of participants with EFS at 5 years post-randomization in BMT CTN 0702 are equal for those assigned to Tandem auto transplant and Lenalidomide maintenance therapy.||||0.20
72402215|NCT01480076|144311665|SUPERIORITY_OR_OTHER|||||||0.546|||||||mixed effect model|||Month 12, Non-responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline PCS score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.5460
72402216|NCT01480076|144311665|SUPERIORITY_OR_OTHER||least squares mean|3.3|STANDARD_ERROR_OF_MEAN|0.79|<|0.0001|TWO_SIDED||||||mixed effect model|||Month 12, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline PCS score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
72402217|NCT01480076|144311666|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Overall, Responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MCS score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
72402218|NCT01480076|144311666|SUPERIORITY_OR_OTHER|||||||0.9073|||||||mixed effect model|||Overall, Non-responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MCS score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.9073
72482874|NCT03645954|144492744|OTHER||||||>|0.05||||||The threshold for statistical significance was p = 0.05.|Chi-squared|||||||>0.05
72482875|NCT03971422|144492763|SUPERIORITY||LS Mean Difference|-2.586|||<|0.001|TWO_SIDED|95.0|-4.091|-1.249||Confidence intervals and p-values are based on stage-wise inverse normal combination using the Lehmacher and Wassmer method.|Lehmacher and Wassmer method||Mixed model repeated measure (MMRM) ANCOVA model included treatment group, Baseline score, region, stratification factor (MuSK+ or AChR+) and treatment group by day (interaction term) as fixed factors and participant as a random effect.|The parallel gatekeeping testing procedure with a truncated Hochberg test was used to control the familywise type I error rate at a 2-sided alpha level of 0.05.||-1.249|-4.091|<0.001
72482876|NCT03971422|144492763|SUPERIORITY||LS Mean Difference|-2.619|||<|0.001|TWO_SIDED|95.0|-3.994|-1.163||Confidence intervals and p-values are based on stage-wise inverse normal combination using the Lehmacher and Wassmer method.|Lehmacher and Wassmer method||MMRM analysis of covariance (ANCOVA) model included treatment group, Baseline score, region, stratification factor (MuSK+ or AChR+) and treatment group by day (interaction term) as fixed factors and participant as a random effect.|The parallel gatekeeping testing procedure with a truncated Hochberg test was used to control the familywise type I error rate at a 2-sided alpha level of 0.05.||-1.163|-3.994|<0.001
72482877|NCT03971422|144492764|SUPERIORITY||Odds Ratio (OR)|5.765|||<|0.001|TWO_SIDED|95.0|2.1|14.882||p-value is nominal. Confidence intervals and p-values are based on stage-wise inverse normal combination using the Lehmacher and Wassmer method.|Wald test||The OR of responder rates is estimated and tested between treatment groups using logistic regression model with treatment group, Baseline MG-ADL score and stratification factor (MuSK+ or AChR+). An OR \> 1 favours rozanolixizumab.|||14.882|2.100|<0.001
72482878|NCT03971422|144492764|SUPERIORITY||Odds Ratio (OR)|4.273|||<|0.001|TWO_SIDED|95.0|1.653|11.791||p-value is nominal. Confidence intervals and p-values are based on stage-wise inverse normal combination using the Lehmacher and Wassmer method.|Wald test||The OR of responder rates is estimated and tested between treatment groups using logistic regression model with treatment group, Baseline MG-ADL score and stratification factor (MuSK+ or AChR+). An OR \> 1 favours rozanolixizumab.|||11.791|1.653|<0.001
72482879|NCT03971422|144492765|SUPERIORITY||LS Mean Difference|-3.901|||<|0.001|TWO_SIDED|95.0|-6.634|-1.245||Confidence intervals and p-values are based on stage-wise inverse normal combination using the Lehmacher and Wassmer method.|Lehmacher and Wassmer method||MMRM ANCOVA model included treatment group, Baseline score, region, stratification factor (MuSK+ or AChR+) and treatment group by day (interaction term) as fixed factors and participant as a random effect.|A sequential testing procedure was used. The parallel gatekeeping testing procedure with a truncated Hochberg test was used to control the familywise type I error rate at a 2-sided alpha level of 0.05.||-1.245|-6.634|<0.001
72482880|NCT03971422|144492765|SUPERIORITY||LS Mean Difference|-5.525|||<|0.001|TWO_SIDED|95.0|-8.303|-2.968||Confidence intervals and p-values are based on stage-wise inverse normal combination using the Lehmacher and Wassmer method.|Lehmacher and Wassmer method||MMRM ANCOVA model included treatment group, Baseline score, region, stratification factor (MuSK+ or AChR+) and treatment group by day (interaction term) as fixed factors and participant as a random effect.|A sequential testing procedure was used. The parallel gatekeeping testing procedure with a truncated Hochberg test was used to control the familywise type I error rate at a 2-sided alpha level of 0.05.||-2.968|-8.303|<0.001
72482881|NCT03971422|144492766|SUPERIORITY||LS Mean Difference|-3.483|||<|0.001|TWO_SIDED|95.0|-5.614|-1.584||Confidence intervals and p-values are based on stage-wise inverse normal combination using the Lehmacher and Wassmer method.|Lehmacher and Wassmer method||MMRM ANCOVA model included treatment group, Baseline score, region, stratification factor (MuSK+ or AChR+) and treatment group by day (interaction term) as fixed factors and participant as a random effect.|A sequential testing procedure was used. The parallel gatekeeping testing procedure with a truncated Hochberg test was used to control the familywise type I error rate at a 2-sided alpha level of 0.05.||-1.584|-5.614|<0.001
72482882|NCT03971422|144492766|SUPERIORITY||LS Mean Difference|-4.756|||<|0.001|TWO_SIDED|95.0|-6.821|-2.859||Confidence intervals and p-values are based on stage-wise inverse normal combination using the Lehmacher and Wassmer method.|Lehmacher and Wassmer method||MMRM ANCOVA model included treatment group, Baseline score, region, stratification factor (MuSK+ or AChR+) and treatment group by day (interaction term) as fixed factors and participant as a random effect.|A sequential testing procedure was used. The parallel gatekeeping testing procedure with a truncated Hochberg test was used to control the familywise type I error rate at a 2-sided alpha level of 0.05.||-2.859|-6.821|<0.001
72482883|NCT03971422|144492767|SUPERIORITY||LS Mean Difference|-12.441|||<|0.001|TWO_SIDED|95.0|-21.804|-4.089||Confidence intervals and p-values are based on stage-wise inverse normal combination using the Lehmacher and Wassmer method.|Lehmacher and Wassmer method||MMRM ANCOVA model included treatment group, Baseline score, region, stratification factor (MuSK+ or AChR+) and treatment group by day (interaction term) as fixed factors and participant as a random effect.|A sequential testing procedure was used. The parallel gatekeeping testing procedure with a truncated Hochberg test was used to control the familywise type I error rate at a 2-sided alpha level of 0.05.||-4.089|-21.804|<0.001
72482884|NCT03971422|144492767|SUPERIORITY||LS Mean Difference|-15.163|||<|0.001|TWO_SIDED|95.0|-23.596|-6.45||Confidence intervals and p-values are based on stage-wise inverse normal combination using the Lehmacher and Wassmer method.|Lehmacher and Wassmer method||MMRM ANCOVA model included treatment group, Baseline score, region, stratification factor (MuSK+ or AChR+) and treatment group by day (interaction term) as fixed factors and participant as a random effect.|A sequential testing procedure was used. The parallel gatekeeping testing procedure with a truncated Hochberg test was used to control the familywise type I error rate at a 2-sided alpha level of 0.05.||-6.450|-23.596|<0.001
72511411|NCT02322320|144553249|SUPERIORITY|||||||0.4||||||The analysis involved pairwise comparisons of EFS between the three treatment arms. To control the familywise type I error rate at 0.05, two-sided testing was performed at a Bonferroni-adjusted significance level of 0.0167 = 0.05 / 3.|Log Rank|The log rank test was stratified on risk status at BMT CTN 0702 enrollment (high risk vs. standard risk)||The null hypothesis is that the percentages of participants with EFS at 5 years post-randomization in BMT CTN 0702 are equal for those assigned to RVD consolidation and Lenalidomide maintenance therapy.||||0.40
72567180|NCT00380692|144665271|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-80.9|STANDARD_ERROR_OF_MEAN|77.5||0.299||95.0|-234.3|72.5||P-value for Treatment\*Condition Standard Deviation correct rejections irrelevant target over time.|Mixed Models Analysis|||||72.5|-234.3|0.299
72482885|NCT03971422|144492768|SUPERIORITY||LS Mean Difference|-8.65||||0.012|TWO_SIDED|95.0|-18.058|-0.134||Confidence intervals and p-values are based on stage-wise inverse normal combination using the Lehmacher and Wassmer method.|Lehmacher and Wassmer method||MMRM ANCOVA model included treatment group, Baseline score, region, stratification factor (MuSK+ or AChR+) and treatment group by day (interaction term) as fixed factors and participant as a random effect.|A sequential testing procedure was used. The parallel gatekeeping testing procedure with a truncated Hochberg test was used to control the familywise type I error rate at a 2-sided alpha level of 0.05.||-0.134|-18.058|0.012
72482886|NCT03971422|144492768|SUPERIORITY||LS Mean Difference|-14.822|||<|0.001|TWO_SIDED|95.0|-23.759|-5.936||Confidence intervals and p-values are based on stage-wise inverse normal combination using the Lehmacher and Wassmer method.|Lehmacher and Wassmer method||MMRM ANCOVA model included treatment group, Baseline score, region, stratification factor (MuSK+ or AChR+) and treatment group by day (interaction term) as fixed factors and participant as a random effect.|A sequential testing procedure was used. The parallel gatekeeping testing procedure with a truncated Hochberg test was used to control the familywise type I error rate at a 2-sided alpha level of 0.05.||-5.936|-23.759|<0.001
72482887|NCT03971422|144492769|SUPERIORITY||LS Mean Difference|-11.32|||<|0.001|TWO_SIDED|95.0|-18.958|-4.998||Confidence intervals and p-values are based on stage-wise inverse normal combination using the Lehmacher and Wassmer method.|Lehmacher and Wassmer method||MMRM ANCOVA model included treatment group, Baseline score, region, stratification factor (MuSK+ or AChR+) and treatment group by day (interaction term) as fixed factors and participant as a random effect.|A sequential testing procedure was used. The parallel gatekeeping testing procedure with a truncated Hochberg test was used to control the familywise type I error rate at a 2-sided alpha level of 0.05.||-4.998|-18.958|<0.001
72482888|NCT03971422|144492769|SUPERIORITY||LS Mean Difference|-10.705|||<|0.001|TWO_SIDED|95.0|-17.787|-3.998||Confidence intervals and p-values are based on stage-wise inverse normal combination using the Lehmacher and Wassmer method.|Lehmacher and Wassmer method||MMRM ANCOVA model included treatment group, Baseline score, region, stratification factor (MuSK+ or AChR+) and treatment group by day (interaction term) as fixed factors and participant as a random effect.|A sequential testing procedure was used. The parallel gatekeeping testing procedure with a truncated Hochberg test was used to control the familywise type I error rate at a 2-sided alpha level of 0.05.||-3.998|-17.787|<0.001
72482889|NCT03566810|144492789|EQUIVALENCE|Analysis was performed with Equivalence Acceptance Range for 90% Confidence Interval (CI) as 80.00% - 125.00%.|Ratio of Geometric Least Square(LS)Mean%|98.69|||||TWO_SIDED|90.0|92.2|105.64||||||Statistical Comparison of Test GXR Versus Reference GXR under Fasting conditions.||105.64|92.20|
72482890|NCT03566810|144492789|EQUIVALENCE|Analysis was performed with Equivalence Acceptance Range for 90% Confidence Interval (CI) as 80.00% - 125.00%.|Ratio of Geometric LS Mean Percentage|99.39|||||TWO_SIDED|90.0|93.15|106.05||||||Statistical Comparison of Test GXR Versus Reference GXR under Fed conditions.||106.05|93.15|
72482891|NCT03566810|144492790|EQUIVALENCE|Analysis was performed with Equivalence Acceptance Range for 90% Confidence Interval (CI) as 80.00% - 125.00%.|Ratio of Geometric LS Mean Percentage|98.92|||||TWO_SIDED|90.0|91.08|107.44||||||Statistical Comparison of Test GXR Versus Reference GXR under Fasting conditions.||107.44|91.08|
72482892|NCT03566810|144492790|EQUIVALENCE|Analysis was performed with Equivalence Acceptance Range for 90% Confidence Interval (CI) as 80.00% - 125.00%.|Ratio of Geometric LS Mean Percentage|96.89|||||TWO_SIDED|90.0|89.87|104.46||||||Statistical Comparison of Test GXR Versus Reference GXR under Fed conditions.||104.46|89.87|
72482893|NCT03566810|144492791|EQUIVALENCE|Analysis was performed with Equivalence Acceptance Range for 90% Confidence Interval (CI) as 80.00% - 125.00%.|Median point estimate difference|0.0|||||TWO_SIDED|90.0|-0.5|0.0||||||Statistical Comparison of Test GXR Versus Reference GXR under Fasting conditions.||0.00|-0.50|
72482894|NCT03566810|144492791|EQUIVALENCE|Analysis was performed with Equivalence Acceptance Range for 90% Confidence Interval (CI) as 80.00% - 125.00%.|Median point estimate difference|0.0|||||TWO_SIDED|90.0|-0.5|0.5||||||Statistical Comparison of Test GXR Versus Reference GXR under Fed conditions.||0.50|-0.50|
72482895|NCT03566810|144492793|EQUIVALENCE|Analysis was performed with Equivalence Acceptance Range for 90% Confidence Interval (CI) as 80.00% - 125.00%.|Ratio of Geometric LS Mean Percentage|97.89|||||TWO_SIDED|90.0|91.38|104.86||||||Statistical Comparison of Test GXR Versus Reference GXR under Fasting conditions.||104.86|91.38|
72482896|NCT03566810|144492793|EQUIVALENCE|Analysis was performed with Equivalence Acceptance Range for 90% Confidence Interval (CI) as 80.00% - 125.00%.|Ratio of Geometric LS Mean Percentage|98.08|||||TWO_SIDED|90.0|92.37|104.14||||||Statistical Comparison of Test GXR Versus Reference GXR under Fed conditions.||104.14|92.37|
72482897|NCT00826111|144492842|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0085|STANDARD_ERROR_OF_MEAN|0.0534||0.88|TWO_SIDED|95.0|-0.139|0.0122|||t-test, 2 sided|||||.01220|-0.1390|0.88
72482898|NCT00826111|144492843|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.031|STANDARD_ERROR_OF_MEAN|0.112||0.79|TWO_SIDED|95.0|-0.286|0.224|||t-test, 2 sided|||||0.224|-0.286|0.79
72511412|NCT02322320|144553250|SUPERIORITY|||||||0.43||||||The analysis involved pairwise comparisons of SPM between the three treatment arms. To control the familywise type I error rate at 0.05, two-sided testing was performed at a Bonferroni-adjusted significance level of 0.0167 = 0.05 / 3.|Gray's test|Gray's test was stratified on risk status at BMT CTN 0702 enrollment (high risk vs. standard risk)||The null hypothesis is that the percentages of participants with SPM at 5 years post-randomization in BMT CTN 0702 are equal for those assigned to Tandem auto transplant and RVD consolidation therapy.||||0.43
72511413|NCT02322320|144553250|SUPERIORITY|||||||0.7||||||The analysis involved pairwise comparisons of SPM between the three treatment arms. To control the familywise type I error rate at 0.05, two-sided testing was performed at a Bonferroni-adjusted significance level of 0.0167 = 0.05 / 3.|Gray's test|Gray's test was stratified on risk status at BMT CTN 0702 enrollment (high risk vs. standard risk)||The null hypothesis is that the percentages of participants with SPM at 5 years post-randomization in BMT CTN 0702 are equal for those assigned to Tandem auto transplant and Lenalidomide maintenance therapy.||||0.70
72482899|NCT00826111|144492844|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.0222|STANDARD_ERROR_OF_MEAN|0.0128||0.16|TWO_SIDED|95.0|-0.58|0.0136|||t-test, 2 sided|||||.0136|-0.580|0.16
72482900|NCT00826111|144492845|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.71|STANDARD_ERROR_OF_MEAN|0.515||0.29|TWO_SIDED|95.0|-1.35|2.77|||t-test, 2 sided|||||2.77|-1.35|0.29
72482901|NCT00826111|144492846|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0048|STANDARD_ERROR_OF_MEAN|0.005||0.37|TWO_SIDED|95.0|-0.0077|0.0174|||t-test, 2 sided|||||0.0174|-0.0077|0.37
72511414|NCT02322320|144553250|SUPERIORITY|||||||0.7||||||The analysis involved pairwise comparisons of SPM between the three treatment arms. To control the familywise type I error rate at 0.05, two-sided testing was performed at a Bonferroni-adjusted significance level of 0.0167 = 0.05 / 3.|Gray's test|Gray's test was stratified on risk status at BMT CTN 0702 enrollment (high risk vs. standard risk)||The null hypothesis is that the percentages of participants with SPM at 5 years post-randomization in BMT CTN 0702 are equal for those assigned to RVD consolidation and Lenalidomide maintenance therapy.||||0.70
72482902|NCT00826111|144492847|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0056|STANDARD_ERROR_OF_MEAN|0.0042||0.21|TWO_SIDED|95.0|-0.0037|0.1481|||t-test, 2 sided|||||0.1481|-0.0037|0.21
72482903|NCT00826111|144492848|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.35|STANDARD_ERROR_OF_MEAN|3.94||0.1|TWO_SIDED|95.0|-1.76|16.46|||t-test, 2 sided|||||16.46|-1.76|0.10
72482904|NCT00826111|144492849|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.6|STANDARD_ERROR_OF_MEAN|4.06||0.89|TWO_SIDED|95.0|-9.31|10.51|||t-test, 2 sided|||||10.51|-9.31|0.89
72482905|NCT00826111|144492850|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.7|STANDARD_ERROR_OF_MEAN|3.78||0.66|TWO_SIDED|95.0|-10.31|6.91|||t-test, 2 sided|||||6.91|-10.31|0.66
72511415|NCT00125658|144553267|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||Primary Comparison (i.e., FTP vs. POWER) Data are reported as change scores, between the end of treatment block 1(10 weeks) and baseline; thus, this analysis directly compares FTP vs. Power. A negative value represents improvement (i.e., reduced trunk displacement) while a positive value represents an increase in compensatory trunk movement.||||<.001
72511416|NCT00125658|144553267|SUPERIORITY_OR_OTHER|||||||0.002|||||||t-test, 2 sided|||Order effect, testing OrderA (FTP before POWER) vs. OrderB (POWER before FTP). Change scores for trunk displacement at the end of both treatment blocks (20 weeks) relative to baseline (e.g., 20 weeks - baseline) were compared between OrderA and OrderB.||||.002
72511417|NCT00125658|144553268|SUPERIORITY_OR_OTHER|||||||0.13|||||||t-test, 2 sided|||Tests effect of FTP vs. Power. The change in shoulder flexion range of motion was compared between baseline and the end of treatment Block 1 (i.e., 10 weeks).||||0.13
72511418|NCT00125658|144553268|SUPERIORITY_OR_OTHER|||||||0.048|||||||t-test, 2 sided|||Test the effect of treatment order OrderA (FTP before POWER) vs. OrderB (POWER before FTP). The change in shoulder flexion range of motion was compared between the end of treatment (20 weeks) and baseline.||||0.048
72511419|NCT00125658|144553269|SUPERIORITY_OR_OTHER|||||||0.004|||||||t-test, 2 sided|||Compares FTP vs POWER by comparing the change in elbow extension range of motion between the end of treatment block 1 (10 weeks) and baseline.||||.004
72511420|NCT00125658|144553269|SUPERIORITY_OR_OTHER|||||||0.034|||||||t-test, 2 sided|||Tests for the effect of treatment order OrderA (FTP before POWER) vs. OrderB (POWER before FTP) by comparing the change in elbow extension range of motion between the end of overall treatment (20 weeks) and baseline.||||0.034
72511421|NCT00125658|144553270|SUPERIORITY_OR_OTHER|||||||0.056|||||||t-test, 2 sided|||Tests for differences between FTP vs. POWER by comparing the change in movement speed between the end of treatment block 1 (10 weeks) and baseline.||||0.056
72511422|NCT00125658|144553270|SUPERIORITY_OR_OTHER|||||||0.168|||||||t-test, 2 sided|||Tests for effect of treatment order (OrderA (FTP before POWER) vs. OrderB (POWER before FTP))by comparing the change in movement speed between the end of overall treatment (20 weeks) and baseline.||||.168
72511423|NCT00125658|144553271|SUPERIORITY_OR_OTHER|||||||0.564|||||||Wilcoxon (Mann-Whitney)|||Tests the effects of FTP vs. POWER on motor impairment (UE FMA) by comparing the change in FMA between the end of treatment block 1 (10 weeks) and baseline.||||0.564
72511424|NCT00125658|144553271|SUPERIORITY_OR_OTHER|||||||0.948|||||||Wilcoxon (Mann-Whitney)|||Tests for an effect of treatment order (OrderA (FTP before POWER) vs. OrderB (POWER before FTP)) by comparing the change in UE FMA between the end of treatment (20 weeks) and baseline.||||0.948
72511425|NCT00125658|144553272|SUPERIORITY_OR_OTHER|||||||0.078|||||||t-test, 2 sided|||Tests for differences in FTP vs. POWER by comparing the change in RPR between the end of treatment block 1 (10 weeks) and baseline.||||0.078
72511426|NCT00125658|144553272|SUPERIORITY_OR_OTHER|||||||0.4|||||||t-test, 2 sided|||Tests the effect of treatment order (Order A (FTP \> POWER) vs. Order B (POWER \> FTP)) by comparing the change in RPR between the end of overall treatment (20 weeks) and baseline.||||0.4
72511427|NCT00125658|144553273|SUPERIORITY_OR_OTHER|||||||0.085|||||||t-test, 2 sided|||Tests for the effect of treatment (FTP vs. POWER) by comparing the change in movement smoothness between the end of treatment block 1 (10 weeks) and baseline.||||0.085
72511428|NCT00125658|144553273|SUPERIORITY_OR_OTHER|||||||0.635|||||||t-test, 2 sided|||Tests for the effect of treatment order (OrderA (FTP before POWER) vs. OrderB (POWER before FTP)) by comparing the change in movement smoothness between the end of overall treatment (20 weeks) and baseline.||||0.635
72511429|NCT02876055|144553274|SUPERIORITY|||||||0.542|||||||Wilcoxon (Mann-Whitney)|||||||0.542
72511430|NCT02876055|144553274|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
72511431|NCT02876055|144553274|SUPERIORITY|||||||0.002|||||||Wilcoxon (Mann-Whitney)|||||||0.002
72511432|NCT00364845|144553276|SUPERIORITY_OR_OTHER||Proportion achieving target|0.389||||||95.0|0.173|0.643||||||||0.643|0.173|
72511433|NCT00364845|144553276|SUPERIORITY_OR_OTHER||Proportion achieving target|0.95||||||95.0|0.751|0.999||||||||0.999|0.751|
72511434|NCT04019093|144553285|SUPERIORITY|||||||0.99|||||||ANOVA|F(1,46) = .001||2 (beverage condition: alcohol vs. placebo) X 2 (group: chronic pain vs. healthy control) mixed general linear model on pressure threshold. Here we report the results of the analysis of the beverage condition X group interaction.||||.99
72511435|NCT04019093|144553285|SUPERIORITY||||||<|0.0001|||||||ANOVA|F(1,46)=12.55||2 (beverage condition: alcohol vs. placebo) X 2 (group: chronic pain vs. healthy control) mixed general linear model on pressure threshold. Here we report the results of the analysis of the main effect of beverage condition.||||<.0001
72511436|NCT04019093|144553285|SUPERIORITY|||||||0.015|||||||ANOVA|F(1,46)=6.32||2 (beverage condition: alcohol vs. placebo) X 2 (group: chronic pain vs. healthy control) mixed general linear model on pressure threshold. Here we report the results of the analysis of the main effect of group.||||.015
72482906|NCT01672788|144492851|NON_INFERIORITY_OR_EQUIVALENCE|Considered characteristic is empa 12.5mg fixed-dose divided by empa 12.5mg free dose|Geometric Mean Ratio|101.31|STANDARD_DEVIATION|10.7|||TWO_SIDED|90.0|96.89|105.93|||ANOVA|Based on an ANOVA including the random effect subjects within sequences and the fixed effects sequence, period and treatment.|Standard deviation is actually the geometric coefficient of variation (gCV)|||105.93|96.89|
72482907|NCT01672788|144492851|NON_INFERIORITY_OR_EQUIVALENCE|Considered characteristic is empa 5mg fixed-dose divided by empa 5mg free dose|Geometric Mean Ratio|100.3|STANDARD_DEVIATION|7.0|||TWO_SIDED|90.0|97.4|103.29|||ANOVA|Based on an ANOVA including the random effect subjects within sequences and the fixed effects sequence, period and treatment.|Standard deviation is actually the geometric coefficient of variation (gCV)|||103.29|97.40|
72482908|NCT01672788|144492852|NON_INFERIORITY_OR_EQUIVALENCE|Considered characteristic is empa 12.5mg fixed-dose divided by empa 12.5mg free dose.|Geometric Mean Ratio|101.61|STANDARD_DEVIATION|8.8|||TWO_SIDED|90.0|97.94|105.41|||ANOVA|Based on an ANOVA including the random effect subjects within sequences and the fixed effects sequence, period and treatment.|Standard deviation is actually the gCV|||105.41|97.94|
72482909|NCT01672788|144492852|NON_INFERIORITY_OR_EQUIVALENCE|Considered characteristic is empa 5mg fixed-dose divided by empa 5mg free dose.|Geometric Mean Ratio|98.56|STANDARD_DEVIATION|10.8|||TWO_SIDED|90.0|94.24|103.08|||ANOVA|Based on an ANOVA including the random effect subjects within sequences and the fixed effects sequence, period and treatment.|Standard deviation is actually the gCV|||103.08|94.24|
72482910|NCT01672788|144492853|NON_INFERIORITY_OR_EQUIVALENCE|Considered characteristic is empa 12.5mg fixed-dose divided by empa 12.5mg free dose|Geometric Mean Ratio|101.2|STANDARD_DEVIATION|10.4|||TWO_SIDED|90.0|96.89|105.71|||ANOVA|Based on an ANOVA including the random effect subjects within sequences and the fixed effects sequence, period and treatment.|Standard deviation is actually the geometric coefficient of variation (gCV)|||105.71|96.89|
72482911|NCT01672788|144492853|NON_INFERIORITY_OR_EQUIVALENCE|Considered characteristic is empa 5mg fixed-dose divided by empa 5mg free dose|Geometric Mean Ratio|100.31|STANDARD_DEVIATION|7.0|||TWO_SIDED|90.0|97.41|103.3|||ANOVA|Based on an ANOVA including the random effect subjects within sequences and the fixed effects sequence, period and treatment.|Standard deviation is actually the gCV|||103.30|97.41|
72482912|NCT01672788|144492854|NON_INFERIORITY_OR_EQUIVALENCE|Considered characteristic is empa 12.5mg fixed-dose divided by empa 12.5mg free dose|Geometric Mean Ratio|102.7|STANDARD_DEVIATION|9.4|||TWO_SIDED|90.0|98.75|106.81|||ANOVA|Based on an ANOVA including the random effect subjects within sequences and the fixed effects sequence, period and treatment.|Standard deviation is actually the geometric coefficient of variation (gCV)|||106.81|98.75|
72482913|NCT01672788|144492854|NON_INFERIORITY_OR_EQUIVALENCE|Considered characteristic is empa 5mg fixed-dose divided by empa 5mg free dose|Geometric Mean Ratio|100.97|STANDARD_DEVIATION|12.3|||TWO_SIDED|90.0|95.94|106.27|||ANOVA|Based on an ANOVA including the random effect subjects within sequences and the fixed effects sequence, period and treatment.|Standard deviation is actually the gCV|||106.27|95.94|
72482914|NCT01672788|144492855|NON_INFERIORITY_OR_EQUIVALENCE|Considered characteristic is empa 12.5mg fixed-dose divided by empa 12.5mg free dose .|Geometric Mean Ratio|99.64|STANDARD_DEVIATION|10.5|||TWO_SIDED|90.0|95.39|104.09|||ANOVA|Based on an ANOVA including the random effect subjects within sequences and the fixed effects sequence, period and treatment.|Standard deviation is actually the geometric coefficient of variation (gCV)|||104.09|95.39|
72482915|NCT01672788|144492855|NON_INFERIORITY_OR_EQUIVALENCE|Considered characteristic is empa 5mg fixed-dose divided by empa 5mg free dose.|Geometric Mean Ratio|97.89|STANDARD_DEVIATION|10.2|||TWO_SIDED|90.0|93.82|102.15|||ANOVA|Based on an ANOVA including the random effect subjects within sequences and the fixed effects sequence, period and treatment.|Standard deviation is actually the gCV|||102.15|93.82|
72482916|NCT01672788|144492856|NON_INFERIORITY_OR_EQUIVALENCE|Considered characteristic is empa 12.5mg fixed-dose divided by empa 12.5mg free dose .|Geometric Mean Ratio|101.51|STANDARD_DEVIATION|8.6|||TWO_SIDED|90.0|97.95|105.21|||ANOVA|Based on an ANOVA including the random effect subjects within sequences and the fixed effects sequence, period and treatment.|Standard deviation is actually the geometric coefficient of variation (gCV)|||105.21|97.95|
72482917|NCT01672788|144492856|NON_INFERIORITY_OR_EQUIVALENCE|Considered characteristic is empa 5mg fixed-dose divided by empa 5mg free dose .|Geometric Mean Ratio|98.57|STANDARD_DEVIATION|10.1|||TWO_SIDED|90.0|94.5|102.81|||ANOVA|Based on an ANOVA including the random effect subjects within sequences and the fixed effects sequence, period and treatment.|Standard deviation is actually the gCV|||102.81|94.50|
72482918|NCT02445196|144492857|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.57||||0.035|TWO_SIDED||||||ANOVA|||Repeated measures ANOVAs assessed the condition by time (baseline to posttreatment) interaction effects covarying PTSD treatment. Following the ITT principle, data from all randomized participants were analyzed and multiple imputation replaced missing values. A power analysis indicated that to achieve 80% power to detect an effect size in the magnitude (i.e., d = 0.25 to .33) with alpha of .05 and a correlation between repeated measures of .5, 60 participants per condition would be needed.||||.035
72482919|NCT02445196|144492858|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.87||||0.086|TWO_SIDED||||||ANOVA|||||||.086
72482920|NCT02445196|144492859|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.75||||0.007|TWO_SIDED||||||ANOVA|||||||.007
72511437|NCT04019093|144553286|SUPERIORITY|||||||0.76|||||||ANOVA|F(2,82)=.20||2 (beverage condition: alcohol vs. placebo) X 2 (group: chronic pain vs. healthy control) x 2 (pressure level: 4 lbf vs. 5 lbf vs 6 lbf) mixed general linear model on pain intensity. Here we report the results of the analysis of the pressure level X group interaction.||||.76
72567181|NCT00380692|144665271|SUPERIORITY_OR_OTHER||Mean Difference (Net)|13.6|STANDARD_ERROR_OF_MEAN|67.1||0.84||95.0|-119.3|146.5||P-value for Treatment\*Condition Standard Deviation correct rejections relevant nontarget over time.|Mixed Models Analysis|||||146.5|-119.3|0.840
72482921|NCT02445196|144492860|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.72||||0.005|TWO_SIDED||||||ANOVA|||||||.005
72482922|NCT02445196|144492861|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.78||||0.113|TWO_SIDED||||||t-test, 2 sided|||||||.113
72482923|NCT04697264|144492890|OTHER|Univariate linear regression was initially performed, followed by multivariate regression using the significant associations from the univariate analysis.||||||0.026||||||Adjustments to the p-values for multiple comparison were performed using Benjamini and Hochberg approach on 'R' and represented in the text as adjusted p-value.|Regression, Linear|||The influence of age on adiponectin levels was analysed by dividing the population into binary groups (\<60 years and \>/= 60 years) to facilitate comparison.||||0.026
72511438|NCT04019093|144553286|SUPERIORITY|||||||0.52|||||||ANCOVA|F(2,82)=.66||2 (beverage condition: alcohol vs. placebo) X 2 (group: chronic pain vs. healthy control) x 2 (pressure level: 4 lbf vs. 5 lbf vs 6 lbf) mixed general linear model on pain intensity. Here we report the results of the analysis of the pressure level X beverage condition interaction.||||.52
72567182|NCT00380692|144665272|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.3|STANDARD_ERROR_OF_MEAN|2.8||0.126||95.0|-1.2|9.9||P-value for Treatment differences in Error Rate over time.|Mixed Models Analysis|||||9.9|-1.2|0.126
72567183|NCT00380692|144665272|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.8|STANDARD_ERROR_OF_MEAN|1.7||0.297||95.0|-5.2|1.6||P-value for Treatment\*Error Rate absent over time.|Mixed Models Analysis|||||1.6|-5.2|0.297
72567184|NCT00380692|144665272|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.1|STANDARD_ERROR_OF_MEAN|2.1||0.023||95.0|-9.4|-0.7||P-value for Treatment\*Targets Load 1 over time.|Mixed Models Analysis|||||-0.7|-9.4|0.023
72567185|NCT00380692|144665273|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-87.2|STANDARD_ERROR_OF_MEAN|71.7||0.228||95.0|-230.4|56.0||P-value for Treatment differences in Reaction Time over time.|Mixed Models Analysis|||||56.0|-230.4|0.228
72482924|NCT04697264|144492890|OTHER|Univariate linear regression was initially performed, followed by multivariate regression using the significant associations from the univariate analysis.||||||0.496||||||Adjustments to the p-values for multiple comparisons were performed using Benjamini and Hochberg approach on 'R'.|Regression, Linear|||The influence of age on adiponectin levels was analysed by dividing the population into binary groups (\<60years and \>/=60years) to facilitate comparison.||||0.496
72482925|NCT04697264|144492890|OTHER|Univariate linear regression was initially performed, followed by multivariate regression using the significant associations from the univariate analysis.|||||>|0.05|||||||Regression, Linear|||The influence of age on leptin levels was analysed by dividing the population into binary groups (\<60years and \>/=60years) to facilitate comparison.||||>0.05
72482926|NCT04697264|144492890|OTHER|Univariate linear regression was initially performed, followed by multivariate regression using the significant associations from the univariate analysis.|||||>|0.05||||||Adjustments to the p-values for multiple comparisons were performed using Benjamini and Hochberg approach on 'R'.|Regression, Linear|||The influence of age on IGF1 and 2 levels were analysed by dividing the population into binary groups (\<60years and \>/=60years) to facilitate comparison.||||>0.05
72482927|NCT04697264|144492890|OTHER|Univariate linear regression was initially performed, followed by multivariate regression using the significant associations from the univariate analysis. Adjustments to the p-values for multiple comparisons were performed using Benjamini and Hochberg approach on 'R'.|||||>|0.05||||||Adjustments to the p-values for multiple comparisons were performed using Benjamini and Hochberg approach on 'R'.|Regression, Linear|||The influence of age on IGF1 and 2 levels were analysed by dividing the population into binary groups (\<60years and \>/=60years) to facilitate comparison.||||>0.05
72511439|NCT04019093|144553286|SUPERIORITY|||||||0.04|||||||ANOVA|F(1,41)=4.53, p=.04||2 (beverage condition: alcohol vs. placebo) X 2 (group: chronic pain vs. healthy control) x 2 (pressure level: 4 lbf vs. 5 lbf vs 6 lbf) mixed general linear model on pain intensity. Here we report the results of the analysis of the main effect of beverage condition.||||.04
72511440|NCT04019093|144553286|SUPERIORITY|||||||0.017|||||||ANOVA|F(1,41)=6.24||2 (beverage condition: alcohol vs. placebo) X 2 (group: chronic pain vs. healthy control) x 2 (pressure level: 4 lbf vs. 5 lbf vs 6 lbf) mixed general linear model on pain intensity. Here we report the results of the analysis of the main effect of group.||||.017
72567186|NCT00380692|144665273|SUPERIORITY_OR_OTHER||Mean Difference (Net)|87.6|STANDARD_ERROR_OF_MEAN|77.3||0.26||95.0|-65.6|240.8||P-value for Treatment\*Condition Mean Reaction Time correct rejections Load 1 over time.|Mixed Models Analysis|||||240.8|-65.6|0.260
72567187|NCT00380692|144665273|SUPERIORITY_OR_OTHER||Mean Difference (Net)|70.4|STANDARD_ERROR_OF_MEAN|59.5||0.239||95.0|-47.3|188.2||P-value for Treatment\*Condition Mean Reaction Time correct rejections Load 2 over time.|Mixed Models Analysis|||||188.2|-47.3|0.239
72567188|NCT00380692|144665273|SUPERIORITY_OR_OTHER||Mean Difference (Net)|122.7|STANDARD_ERROR_OF_MEAN|80.1||0.128||95.0|-35.9|281.4||P-value for Treatment\*Condition Mean Reaction Time hits Load 1 over time.|Mixed Models Analysis|||||281.4|-35.9|0.128
72511441|NCT04019093|144553286|SUPERIORITY||||||<|0.0001|||||||ANOVA|F(2,82)=48.41||2 (beverage condition: alcohol vs. placebo) X 2 (group: chronic pain vs. healthy control) x 2 (pressure level: 4 lbf vs. 5 lbf vs 6 lbf) mixed general linear model on pain intensity. Here we report the results of the analysis of the main effect of pressure level.||||<.0001
72567189|NCT00380692|144665274|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-175.5|STANDARD_ERROR_OF_MEAN|88.0||0.051||95.0|-351.5|0.5||P-value for Treatment differences in Standard Deviation of Reaction Time over time.|Mixed Models Analysis|||||0.5|-351.5|0.051
72567190|NCT00380692|144665274|SUPERIORITY_OR_OTHER||Mean Difference (Net)|218.1|STANDARD_ERROR_OF_MEAN|90.8||0.018||95.0|38.0|398.2||P-value for Treatment\*Condition Standard Deviation correct rejections Load 1 over time.|Mixed Models Analysis|||||398.2|38.0|0.018
72567191|NCT00380692|144665274|SUPERIORITY_OR_OTHER||Mean Difference (Net)|173.6|STANDARD_ERROR_OF_MEAN|105.6||0.103||95.0|-35.7|383.0||P-value for Treatment\*Condition Standard Deviation correct rejections Load 2 over time.|Mixed Models Analysis|||||383.0|-35.7|0.103
72567192|NCT00380692|144665274|SUPERIORITY_OR_OTHER||Mean Difference (Net)|205.5|STANDARD_ERROR_OF_MEAN|99.9||0.042||95.0|7.5|403.6||P-value for Treatment\*Condition Standard Deviation hits Load 1 over time.|Mixed Models Analysis|||||403.6|7.5|0.042
72567193|NCT00380692|144665275|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-7.3|STANDARD_ERROR_OF_MEAN|4.6||0.128||95.0|-16.9|2.3||P-value for Treatment difference in Accuracy over time.|Mixed Models Analysis|||||2.3|-16.9|0.128
72567194|NCT00380692|144665276|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-6.1|STANDARD_ERROR_OF_MEAN|2.4||0.022||95.0|-11.2|-1.0||P-value for Treatment difference in Stability of Movement over time.|Mixed Models Analysis|||||-1.0|-11.2|0.022
72567195|NCT00380692|144665277|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.6|STANDARD_ERROR_OF_MEAN|2.0||0.43||95.0|-2.4|5.7||P-value for Treatment difference in Error Rate over time.|Mixed Models Analysis|||||5.7|-2.4|0.430
72482928|NCT04697264|144492890|OTHER|Univariate linear regression was initially performed, followed by multivariate regression using the significant associations from the univariate analysis.|||||>|0.05||||||Adjustments to the p-values for multiple comparisons were performed using Benjamini and Hochberg approach on 'R'.|Regression, Linear|||The influence of menopausal status on levels of adiponectin, leptin, IGF1 and 2 were analysed by dividing the population into binary groups (pre-menopausal and menopausal) to facilitate comparison.||||>0.05
72511442|NCT04019093|144553287|SUPERIORITY|||||||0.5|||||||ANOVA|F (2, 82) = 0.69||2 (beverage condition: alcohol vs. placebo) X 2 (group: chronic pain vs. healthy control) x 2 (pressure level: 4 lbf vs. 5 lbf vs 6 lbf) mixed general linear model on pain relief. Here we report the results of the analysis of the beverage condition X pressure level X group interaction.||||.50
72511443|NCT04019093|144553287|SUPERIORITY|||||||0.21|||||||ANOVA|F(2,82)=1.58||2 (beverage condition: alcohol vs. placebo) X 2 (group: chronic pain vs. healthy control) x 2 (pressure level: 4 lbf vs. 5 lbf vs 6 lbf) mixed general linear model on pain relief. Here we report the results of the analysis of the beverage condition X pressure level interaction.||||.21
72511444|NCT04019093|144553287|SUPERIORITY|||||||0.053|||||||ANOVA|F(2,82)=3.06||2 (beverage condition: alcohol vs. placebo) X 2 (group: chronic pain vs. healthy control) x 2 (pressure level: 4 lbf vs. 5 lbf vs 6 lbf) mixed general linear model on pain relief. Here we report the results of the analysis of the pressure level X group interaction.||||.053
72511445|NCT04019093|144553287|SUPERIORITY|||||||0.98|||||||ANOVA|F(1,41)=.001||2 (beverage condition: alcohol vs. placebo) X 2 (group: chronic pain vs. healthy control) x 2 (pressure level: 4 lbf vs. 5 lbf vs 6 lbf) mixed general linear model on pain relief. Here we report the results of the analysis of the beverage condition X group interaction.||||.98
72511446|NCT04019093|144553287|SUPERIORITY|||||||0.71|||||||ANOVA|F(2,82)=.34||2 (beverage condition: alcohol vs. placebo) X 2 (group: chronic pain vs. healthy control) x 2 (pressure level: 4 lbf vs. 5 lbf vs 6 lbf) mixed general linear model on pain relief. Here we report the results of the analysis of the main effect of pressure level.||||.71
72511447|NCT04019093|144553287|SUPERIORITY|||||||0.71|||||||ANOVA|F(1,41)=.14||2 (beverage condition: alcohol vs. placebo) X 2 (group: chronic pain vs. healthy control) x 2 (pressure level: 4 lbf vs. 5 lbf vs 6 lbf) mixed general linear model on pain relief. Here we report the results of the analysis of the main effect of group.||||.71
72511448|NCT04019093|144553287|SUPERIORITY||||||<|0.0001|||||||ANOVA|F(1,41)=55.02||2 (beverage condition: alcohol vs. placebo) X 2 (group: chronic pain vs. healthy control) x 2 (pressure level: 4 lbf vs. 5 lbf vs 6 lbf) mixed general linear model on pain relief. Here we report the results of the analysis of the main effect of beverage condition.||||<.0001
72511449|NCT03453151|144553299|OTHER|||||||0.053|||||||Paired t-test|||||||0.053
72511450|NCT03453151|144553300|OTHER||||||<|0.001|||||||Paired t-test|||||||<0.001
72511451|NCT03453151|144553301|OTHER||||||<|0.001|||||||Paired t-test|||||||<0.001
72511452|NCT03453151|144553302|OTHER|||||||0.077|||||||Paired t-test|This analysis refers to the resting cardiac index.||||||0.077
72511453|NCT03453151|144553302|OTHER|||||||0.069|||||||Paired t-test|This analysis refers to the peak exercise cardiac index.||||||0.069
72511454|NCT03453151|144553304|OTHER|||||||0.25|||||||Paired t-test|This analysis refers to creatinine level.||||||0.250
72511455|NCT03453151|144553304|OTHER|||||||0.014|||||||Paired t-test|This analysis refers to BUN level.||||||0.014
72511456|NCT03492463|144553311|SUPERIORITY|||||||0.01|||||||Regression, Linear|||Due to time and budget constraints a blinded decision was made and approved by the funding agency to limit further enrollment to the two conditions that provided nicotine patches. The primary (one-tailed) test compared Nicotine e-cigs + Nicotine patches to Non-nicotine e-cigs + Nicotine patches.||||0.01
72511457|NCT03492463|144553312|SUPERIORITY|||||||0.8|||||||ANOVA|||||||0.8
72511458|NCT03492463|144553313|SUPERIORITY|||||||0.5|||||||ANOVA|||||||0.5
72511459|NCT00488618|144553315|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-6.1|||<|0.0001|TWO_SIDED|95.0|-8.9|-3.3|||ANCOVA||cariprazine - placebo|||-3.3|-8.9|<0.0001
72511460|NCT00488618|144553316|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.64||||0.0001|TWO_SIDED|95.0|-0.97|-0.32|||ANCOVA||cariprazine - placebo|||-0.32|-0.97|0.0001
72511461|NCT00797797|144553334|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Regression, Logistic|||The responder rates between 'No Treatment Added' and 'Milnacipran Added' groups were compared using a logistic regression model.||||<0.001
72511462|NCT00797797|144553335|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-14.35|||||TWO_SIDED|95.0|-18.99|-9.71|||ANCOVA|||This parameter was analyzed using an ANCOVA model with treatment group and study center as factors and baseline value as a covariate.||-9.71|-18.99|
72511463|NCT01575197|144553336|SUPERIORITY_OR_OTHER|||||||0.014|TWO_SIDED||||||Fisher Exact|||||||0.014
72511464|NCT01575197|144553337|SUPERIORITY_OR_OTHER|||||||0.16|TWO_SIDED||||||Fisher Exact|||||||0.16
72511465|NCT01575197|144553338|SUPERIORITY_OR_OTHER|||||||0.038|TWO_SIDED||||||t-test, 2 sided|||||||0.038
72511466|NCT01575197|144553339|SUPERIORITY_OR_OTHER|||||||0.3|TWO_SIDED||||||t-test, 2 sided|||||||0.30
72511467|NCT01848054|144553384|NON_INFERIORITY_OR_EQUIVALENCE|The primary efficacy analysis of retention in treatment at Day 3 was assessed in the per protocol population. In addition, a sensitivity analysis assessed retention in treatment in the full analysis population. For these assessments, the margin to determine non-inferiority (i.e., lower limit of the 95% CI for the difference between BNX and generic buprenorphine of ≥-10%) was selected based on clinical experience to justify comparison between the 2 treatments.|||||<|0.05|TWO_SIDED|95.0|||||t-test, 2 sided|Comparisons between treatment groups were reported with 2-sided p values using 95% CIs for the difference.||||||<0.05
72482929|NCT04697264|144492890|OTHER|Univariate linear regression was initially performed, followed by multivariate regression using the significant associations from the univariate analysis.||||||0.014||||||Adjustments to the p-values for multiple comparisons were performed using Benjamini and Hochberg approach on 'R'.|Regression, Linear|||The influence of menopausal status on levels of adiponectin was analysed by dividing the population into binary groups (pre-menopausal and menopausal) to facilitate comparison.||||0.014
72511468|NCT01848054|144553391|NON_INFERIORITY_OR_EQUIVALENCE|The primary efficacy analysis of retention in treatment at Day 3 was assessed in the per protocol population. In addition, a sensitivity analysis assessed retention in treatment in the full analysis population. For these assessments, the margin to determine non-inferiority (i.e., lower limit of the 95% CI for the difference between BNX and generic buprenorphine of ≥-10%) was selected based on clinical experience to justify comparison between the 2 treatments.|||||<|0.05|TWO_SIDED|95.0|||||t-test, 2 sided|Comparisons between treatment groups were reported with 2-sided p values using 95% CIs for the difference.||||||<0.05
72511469|NCT01826422|144553401|SUPERIORITY||||||<|0.05||||||Between-groups analysis (omega 3 vs placebo) at 3 and 6 months.|Wilcoxon (Mann-Whitney)|||||||<0.05
72511470|NCT01826422|144553402|SUPERIORITY_OR_OTHER||||||>|0.05||||||Between-groups analysis (omega 3 vs placebo) at 3 and 6 months.|Wilcoxon (Mann-Whitney)|||||||>0.05
72511471|NCT01826422|144553403|SUPERIORITY_OR_OTHER||||||>|0.05||||||Between-groups analysis (omega 3 vs placebo) at 3 and 6 months.|Wilcoxon (Mann-Whitney)|||||||>0.05
72511472|NCT01826422|144553404|SUPERIORITY_OR_OTHER||||||<|0.05||||||Between-groups analysis (omega 3 vs placebo) at 3 and 6 months.|Wilcoxon (Mann-Whitney)|||||||<0.05
72511473|NCT01826422|144553405|SUPERIORITY||||||<|0.05||||||Between-groups analysis (omega 3 vs placebo) at 3 and 6 months.|Wilcoxon (Mann-Whitney)|||||||<0.05
72511474|NCT01826422|144553406|SUPERIORITY_OR_OTHER||||||>|0.05||||||Between-groups analysis (omega 3 vs placebo) at 3 and 6 months.|Kruskal-Wallis|||||||>0.05
72482930|NCT04697264|144492890|OTHER|Univariate linear regression was initially performed, followed by multivariate regression using the significant associations from the univariate analysis.||||||0.006||||||Adjustments to the p-values for multiple comparisons were performed using Benjamini and Hochberg approach on 'R'.|Regression, Linear|||The influence of menopausal status on levels of leptin was analysed by dividing the population into binary groups (pre-menopausal and menopausal) to facilitate comparison.||||0.006
72482931|NCT04697264|144492890|OTHER|Univariate linear regression was initially performed, followed by multivariate regression using the significant associations from the univariate analysis.||||||0.019||||||Adjustments to the p-values for multiple comparisons were performed using Benjamini and Hochberg approach on 'R'.|Regression, Linear|||The influence of menopausal status on levels of IGF1 and IGF2 were analysed by dividing the population into binary groups (pre-menopausal and menopausal) to facilitate comparison.||||0.019
72482932|NCT04697264|144492891|OTHER|Univariate linear regression was initially performed, followed by multivariate regression using the significant associations from the univariate analysis.||||||0.033||||||Adjustments to the p-values for multiple comparison were performed using Benjamini and Hochberg approach on 'R'.|Regression, Linear|||Effects of LVSI on adiponectin levels were assessed using multivariate linear regression, with binary categorisations (presence and absence of LVSI) to facilitate comparisons.||||0.033
72482933|NCT04697264|144492891|OTHER|Univariate linear regression was initially performed, followed by multivariate regression using the significant associations from the univariate analysis.||||||0.015||||||Adjustments to the p-values for multiple comparisons were performed using Benjamini and Hochberg approach on 'R'.|Regression, Linear|||Effects of MELF on TNF levels were assessed using multivariate linear regression, with binary categorisations (presence and absence of MELF) to facilitate comparisons.||||0.015
72482934|NCT04697264|144492891|OTHER|Univariate linear regression was initially performed, followed by multivariate regression using the significant associations from the univariate analysis.|||||>|0.05||||||Adjustments to the p-values for multiple comparisons were performed using Benjamini and Hochberg approach on 'R'.|Regression, Linear|||Effects of tumour grade (Grade 1/2), stage (Stage 1/ \>/=1), histology (type 1 and type 2), and MSI (presence or absence) on the biomarker levels (adiponectin, leptin, IGF 1 and 2, IL6 and TNF) were assessed using multivariate linear regression, with binary categorisations to facilitate comparisons.||||>0.05
72482935|NCT04697264|144492892|OTHER||||||<|0.0001||||||Adjustments to the p-values for multiple comparison were performed using the Benjamini and Hochberg approach in 'R'.|Regression, Linear|||To compare biomarker levels between study and control populations, a linear regression model was used, adjusting for BMI, diabetes, and parity, which are the unmatched factors between the study and control groups. This adjustment aimed to mitigate the confounding impact of these factors, considering their individual influence on the risk of endometrial cancer.||||<0.0001
72511475|NCT01826422|144553407|SUPERIORITY||||||<|0.05||||||Between-groups analysis (omega 3 vs placebo) at 3 and 6 months.|Kruskal-Wallis|||||||<0.05
72511476|NCT01826422|144553408|SUPERIORITY_OR_OTHER||||||<|0.05||||||Between-groups analysis (omega 3 vs placebo) at 3 and 6 months.|Kruskal-Wallis|||||||<0.05
72511477|NCT01826422|144553409|SUPERIORITY||||||<|0.05||||||Between-groups analysis (omega 3 vs placebo) at 3 and 6 months.|Kruskal-Wallis|||||||<0.05
72511478|NCT01826422|144553410|SUPERIORITY||||||<|0.05||||||Between-groups analysis (omega 3 vs placebo) at 3 and 6 months.|t-test, 1 sided|||||||<0.05
72511479|NCT01826422|144553411|SUPERIORITY||||||<|0.05||||||Between-groups analysis (omega 3 vs placebo) at 3 and 6 months.|t-test, 1 sided|||||||<0.05
72511480|NCT01826422|144553412|SUPERIORITY|||||||0.05||||||Between-groups analysis (omega 3 vs placebo) at 3 and 6 months.|t-test, 1 sided|||||||0.05
72511481|NCT01826422|144553413|SUPERIORITY||||||>|0.05||||||Between-groups analysis (omega 3 vs placebo) at 3 and 6 months.|Kruskal-Wallis|||||||>0.05
72511482|NCT01826422|144553414|SUPERIORITY||||||>|0.05||||||Between-groups analysis (omega 3 vs placebo) at 3 and 6 months.|Kruskal-Wallis|||||||>0.05
72511483|NCT01826422|144553415|SUPERIORITY||||||>|0.05||||||Between-groups analysis (omega 3 vs placebo) at 3 and 6 months.|Kruskal-Wallis|||||||>0.05
72511484|NCT01826422|144553416|SUPERIORITY_OR_OTHER||||||>|0.05||||||Between-groups analysis (omega 3 vs placebo) at 3 and 6 months.|Kruskal-Wallis|||||||>0.05
72511485|NCT01826422|144553417|SUPERIORITY||||||>|0.05||||||Between-groups analysis (omega 3 vs placebo) at 3 and 6 months.|Kruskal-Wallis|||||||>0.05
72482936|NCT04697264|144492893|OTHER||||||>|0.05||||||Adjustments to the p-values for multiple comparison were performed using the Benjamini and Hochberg approach in 'R'.|Regression, Linear|||To compare biomarker levels between study and control populations, a linear regression model was used, adjusting for BMI, diabetes, and parity, which are the unmatched factors between the study and control groups. This adjustment aimed to mitigate the confounding impact of these factors, considering their individual influence on the risk of endometrial cancer.||||>0.05
72482937|NCT04697264|144492894|OTHER||||||<|0.05||||||Adjustments to the p-values for multiple comparison were performed using the Benjamini and Hochberg approach in 'R'.|Regression, Linear|||To compare biomarker levels between study and control populations, a linear regression model was used, adjusting for BMI, diabetes, and parity, which are the unmatched factors between the study and control groups. This adjustment aimed to mitigate the confounding impact of these factors, considering their individual influence on the risk of endometrial cancer.||||<0.05
72511486|NCT01826422|144553418|SUPERIORITY|||||||0.05||||||Between-groups analysis (omega 3 vs placebo) at 3 and 6 months.|Kruskal-Wallis|||||||0.05
72511487|NCT01826422|144553419|SUPERIORITY|||||||0.05||||||Between-groups analysis (omega 3 vs placebo) at 3 and 6 months.|Wilcoxon (Mann-Whitney)|||||||0.05
72511488|NCT01826422|144553420|SUPERIORITY|||||||0.05||||||Between-groups analysis (omega 3 vs placebo) at 3 and 6 months.|Wilcoxon (Mann-Whitney)|||||||0.05
72511489|NCT03439748|144553428|SUPERIORITY|||||||0.002||||||The threshold for statistical significance was p = 0.05. Univariate tests were corrected for false discovery rate using the Benjamin-Hochberg approach.|Mixed Models Analysis|Baseline levels of outcomes were covaried in all analyses to reduce error variance and correct for group differences.||This analysis compares the PAT and NAT groups at post-treatment. For this analysis, we have greater than .80 power to detect an effect size difference between PAT and NAT as small as d=.35.||||.002
72511490|NCT03439748|144553429|SUPERIORITY||||||>|0.05||||||The threshold for statistical significance was p = 0.05. Univariate tests were corrected for false discovery rate using the Benjamin-Hochberg approach.|Mixed Models Analysis|Baseline levels of outcomes were covaried in all analyses to reduce error variance and correct for group differences.||This analysis compares the PAT and NAT groups at post-treatment. For this analysis, we have greater than .80 power to detect an effect size difference between PAT and NAT as small as d=.35.||||>.05
72511491|NCT03439748|144553430|SUPERIORITY|||||||0.024||||||The threshold for statistical significance was p = 0.05. Univariate tests were corrected for false discovery rate using the Benjamin-Hochberg approach.|Mixed Models Analysis|Baseline levels of outcomes were covaried in all analyses to reduce error variance and correct for group differences.||This analysis compares the PAT and NAT groups at post-treatment. For this analysis, we have greater than .80 power to detect an effect size difference between PAT and NAT as small as d=.35.||||.024
72511492|NCT03439748|144553434|SUPERIORITY|||||||0.922||||||The threshold for statistical significance was p = 0.05. Univariate tests were corrected for false discovery rate using the Benjamin-Hochberg approach.|Mixed Models Analysis|Baseline levels of outcomes were covaried in all analyses to reduce error variance and correct for group differences.||This analysis compares the PAT and NAT groups at post-treatment. For this analysis, we have greater than .80 power to detect an effect size difference as small as d=.39.||||.922
72511493|NCT03439748|144553435|SUPERIORITY|||||||0.049||||||The threshold for statistical significance was p = 0.05. Univariate tests were corrected for false discovery rate using the Benjamin-Hochberg approach.|Mixed Models Analysis|Baseline levels of outcomes were covaried in all analyses to reduce error variance and correct for group differences.||This analysis compares the PAT and NAT groups at post-treatment. For this analysis, we have greater than .80 power to detect an effect size difference as small as d=.39.||||.049
72511494|NCT03439748|144553436|SUPERIORITY|||||||0.591||||||The threshold for statistical significance was p = 0.05. Univariate tests were corrected for false discovery rate using the Benjamin-Hochberg approach.|Mixed Models Analysis|Baseline levels of outcomes were covaried in all analyses to reduce error variance and correct for group differences.||This analysis compares the PAT and NAT groups at post-treatment. For this analysis, we have greater than .80 power to detect an effect size difference as small as d=.39.||||.591
72511495|NCT03439748|144553437|SUPERIORITY|||||||0.004||||||The threshold for statistical significance was p = 0.05. Univariate tests were corrected for false discovery rate using the Benjamin-Hochberg approach.|Mixed Models Analysis|Baseline levels of outcomes were covaried in all analyses to reduce error variance and correct for group differences.||This analysis compares the PAT and NAT groups at post-treatment. For this analysis, we have greater than .80 power to detect an effect size difference as small as d=.39.||||.004
72511496|NCT03439748|144553438|SUPERIORITY|||||||0.03||||||The threshold for statistical significance was p = 0.05. Univariate tests were corrected for false discovery rate using the Benjamin-Hochberg approach.|Mixed Models Analysis|Baseline levels of outcomes were covaried in all analyses to reduce error variance and correct for group differences.||This analysis compares the PAT and NAT groups at post-treatment. For this analysis, we have greater than .80 power to detect an effect size difference as small as d=.39.||||.030
72511497|NCT03439748|144553439|SUPERIORITY|||||||0.029||||||The threshold for statistical significance was p = 0.05. Univariate tests were corrected for false discovery rate using the Benjamin-Hochberg approach.|Mixed Models Analysis|||This analysis compares the PAT and NAT groups at post-treatment. For this analysis, we have greater than .80 power to detect an effect size difference as small as d=.39.||||.029
72511498|NCT03439748|144553441|SUPERIORITY|||||||0.494||||||The threshold for statistical significance was p = 0.05. Univariate tests were corrected for false discovery rate using the Benjamin-Hochberg approach.|Mixed Models Analysis|Baseline levels of outcomes were covaried in all analyses to reduce error variance and correct for group differences.||This analysis compares the PAT and NAT groups at post-treatment. For this analysis, we have greater than .80 power to detect an effect size difference as small as d=.39.||||.494
72567196|NCT00380692|144665277|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-7.0|STANDARD_ERROR_OF_MEAN|2.4||0.005||95.0|-11.8|-2.2||P-value for Treatment\*Condition Error Rate irrelevant targets over time.|Mixed Models Analysis|||||-2.2|-11.8|0.005
72482938|NCT04697264|144492895|OTHER||||||>|0.05||||||Univariate linear regression was initially performed, followed by multivariate regression using the significant associations from the univariate analysis. P value \<0.05 was considered significant.|Regression, Linear|||"The impact of BMI on biomarker levels was assessed by categorising the population into two groups-normal weight and overweight/obese-for straightforward comparison.~Here, we present the associations between adiponectin and the BMI of the study population at baseline."||||>0.05
72482939|NCT04697264|144492895|OTHER|||||||0.09||||||Univariate linear regression was initially performed, followed by multivariate regression using the significant associations from the univariate analysis. P value \<0.05 was considered significant.|Regression, Linear|||"The impact of BMI on biomarker levels was assessed by categorising the population into two groups-normal weight and overweight/obese-for straightforward comparison.~Here, we present the associations between leptin and the BMI of the study population at baseline."||||0.09
72482940|NCT04697264|144492895|OTHER||||||>|0.05||||||Univariate linear regression was initially performed, followed by multivariate regression using the significant associations from the univariate analysis. P value \<0.05 was considered significant.|Regression, Linear|||"The impact of BMI on biomarker levels was assessed by categorising the population into two groups-normal weight and overweight/obese-for straightforward comparison.~Here, we present the association between IL6, TNFα, IGF1, and IGF2 and the BMI of the study population at baseline."||||>0.05
72482941|NCT04697264|144492896|OTHER|||||||0.004||||||Univariate linear regression was initially performed, followed by multivariate regression using the significant associations from the univariate analysis. P value \<0.05 was considered significant.|Regression, Linear|||"The impact of BMI on biomarker levels was assessed by categorising the population into two groups-normal weight and overweight/obese-for straightforward comparison.~Here, we present the associations between adiponectin and the BMI of the control population at baseline."||||0.004
72482942|NCT04697264|144492896|OTHER|||||||0.0002||||||Univariate linear regression was initially performed, followed by multivariate regression using the significant associations from the univariate analysis. P value \<0.05 was considered significant.|Regression, Linear|||"The impact of BMI on biomarker levels was assessed by categorising the population into two groups-normal weight and overweight/obese-for straightforward comparison.~Here, we present the associations between leptin and the BMI of the control population at baseline."||||0.0002
72482943|NCT04697264|144492896|OTHER||||||>|0.05||||||Univariate linear regression was initially performed, followed by multivariate regression using the significant associations from the univariate analysis. P value \<0.05 was considered significant.|Regression, Linear|||"The impact of BMI on biomarker levels was assessed by categorising the population into two groups-normal weight and overweight/obese-for straightforward comparison.~Here, we present the associations between IL6, TNFα, IGF1, and IGF2 and the BMI of the control population at baseline."||||>0.05
72482944|NCT04697264|144492897|OTHER|||||||0.0007||||||Adjustments to the p-values for multiple comparisons were performed using Benjamini and Hochberg approach on 'R'.|Mixed Models Analysis|||||||0.0007
72482945|NCT04697264|144492898|OTHER||||||>|0.05||||||Adjustments to the p-values for multiple comparisons were performed using Benjamini and Hochberg approach on 'R'.|Mixed Models Analysis|||Leptin levels were compared between the day 0 and 6 months post-operative bloods.||||>0.05
72482946|NCT04697264|144492898|OTHER|||||||0.004||||||Adjustments to the p-values for multiple comparisons were performed using Benjamini and Hochberg approach on 'R'.|Mixed Models Analysis|||IGF1 levels were compared between the day 0 and 6 months post-operative bloods.||||0.004
72511499|NCT03439748|144553442|SUPERIORITY|||||||0.231||||||The threshold for statistical significance was p = 0.05. Univariate tests were corrected for false discovery rate using the Benjamin-Hochberg approach.|Mixed Models Analysis|Baseline levels of outcomes were covaried in all analyses to reduce error variance and correct for group differences.||This analysis compares the PAT and NAT groups at post-treatment. For this analysis, we have greater than .80 power to detect an effect size difference as small as d=.39.||||.231
72567197|NCT00380692|144665278|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.6|STANDARD_ERROR_OF_MEAN|2.9||0.221||95.0|-9.6|2.3||P-value for Treatment differences in Error Rates over time.|Mixed Models Analysis|||||2.3|-9.6|0.221
72482947|NCT04697264|144492898|OTHER||||||<|0.0001||||||Adjustments to the p-values for multiple comparisons were performed using Benjamini and Hochberg approach on 'R'.|Mixed Models Analysis|||IGF2 levels were compared between the day 0 and 6 months post-operative bloods.||||<0.0001
72482948|NCT04697264|144492900|OTHER||||||<|0.0001|||||||t-test, 2 sided|||Expression of adiponectin was studied in endometrial cancer tissue and fat tissue using qRT-PCR.||||<0.0001
72482949|NCT04697264|144492900|OTHER||||||<|0.05|||||||t-test, 2 sided|||Expression of leptin and their receptors were studied in endometrial cancer tissue and fat tissue using qRT-PCR.||||<0.05
72482950|NCT04697264|144492900|OTHER||||||>|0.05|||||||t-test, 2 sided|||Expression of adiponectin receptors were studied in endometrial cancer tissue and fat tissue using qRT-PCR.||||>0.05
72482951|NCT04697264|144492901|OTHER|||||||0.0002|||||||t-test, 2 sided|||Expression of adiponectin was studied in endometrial cancer tissue and lymph node tissue using qRT-PCR.||||0.0002
72482952|NCT04697264|144492901|OTHER|||||||0.011|||||||t-test, 2 sided|||Expression of leptin was studied in endometrial cancer tissue and lymphnode tissue using qRT-PCR.||||0.011
72567198|NCT00380692|144665278|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.1|STANDARD_ERROR_OF_MEAN|2.0||0.307||95.0|-2.1|6.3||P-value for Treatment\*Condition Error Rates compatible signals over time.|Mixed Models Analysis|||||6.3|-2.1|0.307
72482953|NCT04697264|144492901|OTHER|||||||0.009|||||||t-test, 2 sided|||The expression of IL6 receptor (IL6R) was studied in endometrial cancer tissue and lymphnode tissue using qRT-PCR.||||0.009
72482954|NCT04697264|144492901|OTHER||||||>|0.05|||||||t-test, 2 sided|||The expression of adiponectin receptor, leptin receptor, IGF1 and IGF 2 receptors, IL6, TNF, IGF1 and IGF2 were studied in endometrial cancer tissue and lymphnode tissue using qRT-PCR.||||>0.05
72482955|NCT04697264|144492902|OTHER||||||>|0.05|||||||Pearson's correlation test|||Circulating adiponectin levels and the expression of these markers and their receptors in endometrial tissue were compared using correlation studies.||||>0.05
72482956|NCT04697264|144492903|OTHER||||||>|0.05|||||||Pearson's correlation test|||Circulating leptin, IGF1 and IGF2 levels and the expression of these markers and their receptors in endometrial tissue were compared using Pearson's correlation studies.||||>0.05
72482957|NCT04697264|144492904|OTHER||||||>|0.05|||||||Pearson's correlation test|||Circulating IL6 and TNF levels and the expression of these markers and their receptors in endometrial tissue were compared using Pearson's correlation studies.||||>0.05
72511500|NCT03439748|144553443|SUPERIORITY|||||||0.344||||||The threshold for statistical significance was p = 0.05. Univariate tests were corrected for false discovery rate using the Benjamin-Hochberg approach.|Mixed Models Analysis|Baseline levels of outcomes were covaried in all analyses to reduce error variance and correct for group differences.||This analysis compares the PAT and NAT groups at post-treatment. For this analysis, we have greater than .80 power to detect an effect size difference as small as d=.39.||||.344
72511501|NCT03439748|144553444|SUPERIORITY|||||||0.267||||||The threshold for statistical significance was p = 0.05. Univariate tests were corrected for false discovery rate using the Benjamin-Hochberg approach.|Mixed Models Analysis|Baseline levels of outcomes were covaried in all analyses to reduce error variance and correct for group differences.||This analysis compares the PAT and NAT groups at post-treatment. For this analysis, we have greater than .80 power to detect an effect size difference as small as d=.39.||||.267
72482958|NCT02072434|144492935|OTHER||Odds Ratio (OR)|0.46|||||TWO_SIDED|95.0|0.12|1.43||||||||1.43|0.12|
72482959|NCT02072434|144492936|OTHER||Odds Ratio (OR)|1.48|||||TWO_SIDED|95.0|0.64|3.55||||||||3.55|0.64|
72482960|NCT02072434|144492937|OTHER||Difference between percentages|-0.72|||||TWO_SIDED|95.0|-1.59|0.15||||||||0.15|-1.59|
72482961|NCT01570036|144492940|OTHER|Kaplan-Meier Survival Analysis|Hazard Ratio (HR)|0.62||||0.18|TWO_SIDED|95.0|0.31|1.25|||Kaplan-Meier Survival Analysis|||||1.25|.31|0.18
72482962|NCT01570036|144492942|OTHER|||||||0.02||||||Comparison of the mean LVEF from baseline to 3 months, 6 months, and 12 months; this time period includes the therapy period of trastuzumab.|ANOVA|||||||0.02
72482963|NCT01570036|144492942|OTHER|||||||0.58||||||The mean LVEF compared at baseline to 3 months, 6 months, 12 months and 24 months; this time period includes the duration of trastuzumab therapy and 1 year after completion of trastuzumab therapy.|ANOVA|||||||0.58
72511502|NCT03439748|144553445|SUPERIORITY|||||||0.051||||||The threshold for statistical significance was p = 0.05. Univariate tests were corrected for false discovery rate using the Benjamin-Hochberg approach.|Mixed Models Analysis|Baseline levels of outcomes were covaried in all analyses to reduce error variance and correct for group differences.||This analysis compares the PAT and NAT groups at post-treatment. For this analysis, we have greater than .80 power to detect an effect size difference as small as d=.39.||||.051
72511503|NCT00782418|144553448|SUPERIORITY_OR_OTHER||Least Squares Mean|1.6|||<|0.001||90.0|1.29|1.92||1-sided, alpha=0.05|ANOVA|||||1.92|1.29|<0.001
72482964|NCT01570036|144492942|OTHER|||||||0.65||||||Evaluating LVEF at all time points with a linear mixed regression model, this analysis compared cardiac ejection fraction over time.|Regression, Linear|||||||0.65
72482965|NCT01570036|144492942|OTHER|||||||0.91||||||This analysis evaluated LVEF at all time points with a linear mixed regression model between randomization arms.|Regression, Linear|||||||0.91
72482966|NCT01570036|144492942|OTHER|||||||0.81||||||This analysis evaluated LVEF at all time points with a linear mixed regression model between the arms over time.|Regression, Linear|||||||0.81
72482967|NCT01570036|144492943|OTHER|||||||0.149|||||||Chi-squared|Comparison of the maximum related local toxicity experienced per patient and compared between treatment arms.||The safety group consisted of any patients who received NPS with GM-CSF or placebo with GM-CSF inoculations.||||0.149
72482968|NCT01570036|144492943|OTHER|||||||0.901|||||||Chi-squared|Comparison of the maximum related systemic toxicity experienced per patient and compared between treatment arms.||||||0.901
72511504|NCT00782418|144553448|SUPERIORITY_OR_OTHER||Least Squares Mean|0.95|||<|0.001||90.0|0.66|1.24|||ANOVA|1-sided, alpha=0.05||||1.24|0.66|<0.001
72482969|NCT01346488|144492948|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||Week 12||||< 0.0001
72482970|NCT01346488|144492948|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||Week 24||||< 0.0001
72482971|NCT01346488|144492948|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||Week 36||||< 0.0001
72482972|NCT01346488|144492948|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||Week 48||||< 0.0001
72482973|NCT01346488|144492948|SUPERIORITY_OR_OTHER|||||||1||||||P-value adjusted for multiplicity|Paired t-test|||at discontinuation of ADA therapy||||1.0000
72482974|NCT01346488|144492948|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||at final assessment||||< 0.0001
72482975|NCT01346488|144492949|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||Week 12||||< 0.0001
72482976|NCT01346488|144492949|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||Week 24||||< 0.0001
72482977|NCT01346488|144492949|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||Week 36||||< 0.0001
72482978|NCT01346488|144492949|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||Week 48||||< 0.0001
72482979|NCT01346488|144492949|SUPERIORITY_OR_OTHER|||||||0.0054||||||P-value adjusted for multiplicity|Paired t-test|||at discontinuation of ADA therapy||||0.0054
72482980|NCT01346488|144492949|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||at final assessment||||< 0.0001
72482981|NCT01346488|144492950|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||Week 12||||<0.0001
72482982|NCT01346488|144492950|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||Week 24||||<0.0001
72482983|NCT01346488|144492950|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||Week 36||||< 0.0001
72482984|NCT01346488|144492950|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||Week 48||||<0.0001
72482985|NCT01346488|144492950|SUPERIORITY_OR_OTHER|||||||0.0592||||||P-value adjusted for multiplicity|Paired t-test|||at discontinuation of ADA therapy||||0.0592
72511505|NCT00782418|144553448|SUPERIORITY_OR_OTHER||Least Squares Mean|2.32|||<|0.001||90.0|1.57|3.06|||ANOVA|1-sided, alpha=0.05||||3.06|1.57|<0.001
72511506|NCT00782418|144553448|SUPERIORITY_OR_OTHER||Least Squares Mean|1.38|||<|0.001||90.0|0.64|2.12|||ANOVA|1-sided, alpha = 0.05||||2.12|0.64|<0.001
72482986|NCT01346488|144492950|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||at final assessment||||< 0.0001
72482987|NCT01346488|144492951|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||Week 12||||< 0.0001
72482988|NCT01346488|144492951|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||Week 24||||<0.0001
72482989|NCT01346488|144492951|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||Week 36||||<0.0001
72482990|NCT01346488|144492951|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||Week 48||||<0.0001
72482991|NCT01346488|144492951|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||at discontinuation of ADA therapy||||< 0.0001
72482992|NCT01346488|144492951|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||at final assessment||||< 0.0001
72482993|NCT01346488|144492952|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||Week 12||||< 0.0001
72482994|NCT01346488|144492952|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||Week 24||||< 0.0001
72482995|NCT01346488|144492952|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||Week 36||||< 0.0001
72482996|NCT01346488|144492952|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||Week 48||||< 0.0001
72482997|NCT01346488|144492952|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||at discontinuation of ADA therapy||||< 0.0001
72482998|NCT01346488|144492952|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||at final assessment||||< 0.0001
72511507|NCT00782418|144553449|SUPERIORITY_OR_OTHER||Least Squares Mean|23.1|||<|0.001||90.0|19.2|27.0|||ANOVA|1-side, alpha = 0.05||||27.0|19.2|<0.001
72511508|NCT00782418|144553449|SUPERIORITY_OR_OTHER||Least Squares Mean|16.4|||<|0.001||90.0|12.6|20.1|||ANOVA|1-side, alpha = 0.05||||20.1|12.6|<0.001
72511509|NCT00782418|144553450|SUPERIORITY_OR_OTHER||Least Squares Mean|545.0|||<|0.001||90.0|451.4|638.7|||ANOVA|1-side, alpha = 0.05||||638.7|451.4|<0.001
72482999|NCT01346488|144492953|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|McNemar|||Week 12 (Remission)||||<0.0001
72483000|NCT01346488|144492953|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|McNemar|||Week 24 (Remission)||||< 0.0001
72483001|NCT01346488|144492953|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|McNemar|||Week 36 (Remission)||||< 0.0001
72483002|NCT01346488|144492953|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|McNemar|||Week 48 (Remission)||||< 0.0001
72483003|NCT01346488|144492953|SUPERIORITY_OR_OTHER||||||=|0.0005||||||P-value adjusted for multiplicity|McNemar|||at discontinuation of ADA therapy (Remission)||||= 0.0005
72511510|NCT00782418|144553450|SUPERIORITY_OR_OTHER||Least Squares Mean|246.6|||<|0.001||90.0|160.9|323.3|||ANOVA|1-side, alpha = 0.05||||323.3|160.9|<0.001
72511511|NCT02902172|144553507|NON_INFERIORITY||Mean Difference (Net)|0.85|||<|0.05|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.05
72511512|NCT01125176|144553554|OTHER|Exact Clopper-Pearson 95% confidence interval for overall response rate.|Proportion (percent)|85.7|||||TWO_SIDED|95.0|73.5|100.0||||||||100.0|73.5|
72511513|NCT04360187|144553559|SUPERIORITY||LS mean of difference|-17.13||||0.0002|TWO_SIDED|95.0|-25.98|-8.27|||Mixed effect Model for Repeated Measures||Crisaborole = Test Vehicle = Reference|||-8.27|-25.98|0.0002
72483004|NCT01346488|144492953|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|McNemar|||at final assessment (Remission)||||< 0.0001
72483005|NCT01346488|144492954|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||Week 12||||< 0.0001
72483006|NCT01346488|144492954|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||Week 24||||< 0.0001
72483007|NCT01346488|144492954|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||Week 36||||< 0.0001
72483008|NCT01346488|144492954|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||Week 48||||< 0.0001
72483009|NCT01346488|144492954|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||at discontinuation of ADA therapy||||< 0.0001
72483010|NCT01346488|144492954|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||at final assessment||||< 0.0001
72511514|NCT04360187|144553563|SUPERIORITY||Risk Difference (RD)|12.9||||0.0124|TWO_SIDED|95.0|2.8|23.1|||normal approximation to response rates||Crisaborole = Test Vehicle = Reference|||23.1|2.8|0.0124
72483011|NCT01346488|144492955|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|McNemar|||Week 12 (Remission)||||< 0.0001
72483012|NCT01346488|144492955|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|McNemar|||Week 24 (Remission)||||< 0.0001
72483013|NCT01346488|144492955|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|McNemar|||Week 36 (Remission)||||< 0.0001
72483014|NCT01346488|144492955|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|McNemar|||Week 48 (Remission)||||< 0.0001
72483015|NCT01346488|144492955|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|McNemar|||at discontinuation of ADA therapy (Remission)||||< 0.0001
72483016|NCT01346488|144492955|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|McNemar|||at final assessment (Remission)||||< 0.0001
72483017|NCT01346488|144492956|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||Week 12||||< 0.0001
72483018|NCT01346488|144492956|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||Week 24||||< 0.0001
72511515|NCT04360187|144553564|SUPERIORITY||Risk Difference (RD)|11.7||||0.0078|TWO_SIDED|95.0|3.1|20.3|||normal approximation to response rates||Crisaborole = Test Vehicle = Reference|||20.3|3.1|0.0078
72511516|NCT04360187|144553565|SUPERIORITY||LS Mean of Difference|-0.79||||0.0009|TWO_SIDED|95.0|-1.26|-0.33|||Mixed effect Model for Repeated Measures||Crisaborole = Test Vehicle = Reference|||-0.33|-1.26|0.0009
72511517|NCT02915367|144553587|OTHER|Pearson chi-square||||||0.93|||||||Chi-squared|||||||0.93
72511518|NCT02915367|144553589|OTHER|Pearson chi-square||||||0.96|||||||Chi-squared|||||||0.96
72511519|NCT01515306|144553612|SUPERIORITY_OR_OTHER_LEGACY||Ratio of Geo LS means|1.09|||||TWO_SIDED|90.0|0.93|1.29|||Mixed Models Analysis|Ratio of Geo LS mean is AUC(0-∞) of Cycle 2/Cycle 1.||||1.29|0.93|
72567199|NCT00380692|144665279|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-22.0|STANDARD_ERROR_OF_MEAN|68.9||0.752||95.0|-163.1|119.1||P-value for Treatment differences in Reaction Time over time.|Mixed Models Analysis|||||119.1|-163.1|0.752
72567200|NCT00380692|144665279|SUPERIORITY_OR_OTHER||Mean Difference (Net)|18.6|STANDARD_ERROR_OF_MEAN|31.9||0.564||95.0|-47.0|84.3||P-value for Treatment\*Condition Mean Reaction Time correct rejections Load 2 over time.|Mixed Models Analysis|||||84.3|-47.0|0.564
72567201|NCT02177136|144665286|SUPERIORITY|||||||0.0434|||||||ANCOVA|ANCOVA model with treatment group and randomization stratification factors as fixed effects and baseline as covariate.||||||0.0434
72567202|NCT02177136|144665286|SUPERIORITY|||||||0.0665|||||||ANCOVA|ANCOVA model with treatment group and randomization stratification factors as fixed effects and baseline as covariate.||||||0.0665
72567203|NCT01032018|144665353|SUPERIORITY_OR_OTHER||Difference of back-transformed means.|-3.5||||0.01||95.0|-6.1|-0.7|||Mixed Models Analysis|||The trial was powered to detect a between-group difference in the 6-month change in depression symptoms. Assuming 5% attrition rate, we estimated that a sample of 150 patients would be needed to have 80% power to detect a clinically meaningful differential change in depression scores between groups of 0.46 SD.||-0.7|-6.1|0.01
72483019|NCT01346488|144492956|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||Week 36||||< 0.0001
72483020|NCT01346488|144492956|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||Week 48||||< 0.0001
72483021|NCT01346488|144492956|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||at discontinuation of ADA therapy||||< 0.0001
72483022|NCT01346488|144492956|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||at final assessment||||< 0.0001
72483023|NCT01346488|144492957|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|McNemar|||Week 12 (Remission)||||< 0.0001
72483024|NCT01346488|144492957|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|McNemar|||Week 24 (Remission)||||< 0.0001
72483025|NCT01346488|144492957|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|McNemar|||Week 36 (Remission)||||< 0.0001
72483026|NCT01346488|144492957|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|McNemar|||Week 48 (Remission)||||< 0.0001
72483027|NCT01346488|144492957|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|McNemar|||at discontinuation of ADA therapy (Remission)||||< 0.0001
72483028|NCT01346488|144492957|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|McNemar|||at final assessment (Remission)||||< 0.0001
72483029|NCT01346488|144492958|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||Week 12||||< 0.0001
72483030|NCT01346488|144492958|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||Week 24||||< 0.0001
72483031|NCT01346488|144492958|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||Week 36||||< 0.0001
72483032|NCT01346488|144492958|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||Week 48||||< 0.0001
72483033|NCT01346488|144492958|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||at discontinuation of ADA therapy||||< 0.0001
72483034|NCT01346488|144492958|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||at final assessment||||< 0.0001
72483035|NCT01346488|144492959|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|McNemar|||Week 12 (Remission)||||< 0.0001
72483036|NCT01346488|144492959|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|McNemar|||Week 24 (Remission)||||< 0.0001
72483037|NCT01346488|144492959|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|McNemar|||Week 36 (Remission)||||< 0.0001
72483038|NCT01346488|144492959|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|McNemar|||Week 48 (Remission)||||< 0.0001
72483039|NCT01346488|144492959|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|McNemar|||at discontinuation of ADA therapy (Remission)||||< 0.0001
72483040|NCT01346488|144492959|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|McNemar|||at final assessment (Remission)||||< 0.0001
72483041|NCT01346488|144492960|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||Week 12||||< 0.0001
72483042|NCT01346488|144492960|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||Week 24||||< 0.0001
72483043|NCT01346488|144492960|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||Week 36||||< 0.0001
72483044|NCT01346488|144492960|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||Week 48||||< 0.0001
72483045|NCT01346488|144492960|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||at discontinuation of ADA therapy||||< 0.0001
72483046|NCT01346488|144492960|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||at final assessment||||< 0.0001
72483047|NCT01008696|144492963|SUPERIORITY_OR_OTHER|||||||0.8849||||||Homozygous extensive metabolizer|Chi-squared|||||||0.8849
72483048|NCT01008696|144492963|SUPERIORITY_OR_OTHER|||||||0.865||||||Heterozygous extensive metabolizer|Chi-squared|||||||0.8650
72483049|NCT01008696|144492963|SUPERIORITY_OR_OTHER|||||||0.266||||||Poor metabolizer|Chi-squared|||||||0.2660
72483050|NCT01008696|144492964|SUPERIORITY_OR_OTHER|||||||0.7734||||||Change at Day 57: Heartburn|Wilcoxon rank-sum test|||||||0.7734
72483051|NCT01008696|144492964|SUPERIORITY_OR_OTHER|||||||0.6414||||||Change at Day 57: Regurgitation|Wilcoxon rank-sum test|||||||0.6414
72483052|NCT01008696|144492964|SUPERIORITY_OR_OTHER|||||||0.7809||||||Change at Day 57: Globus sensation|Wilcoxon rank-sum test|||||||0.7809
72483053|NCT01008696|144492964|SUPERIORITY_OR_OTHER|||||||0.8294||||||Change at Day 57: Chronic cough|Wilcoxon rank-sum test|||||||0.8294
72483054|NCT01008696|144492964|SUPERIORITY_OR_OTHER|||||||0.9874||||||Change at Day 57: Epigastric pain|Wilcoxon rank-sum test|||||||0.9874
72483055|NCT01008696|144492964|SUPERIORITY_OR_OTHER|||||||0.2776||||||Change at Day 57: Non cardiac chest pain|Wilcoxon rank-sum test|||||||0.2776
72567204|NCT03265288|144665355|SUPERIORITY||Least square means difference|0.7716||||0.3449|TWO_SIDED|95.0|-0.8397|2.3828||alpha is set to 0.05|Mixed Model for Repeated Measures||A positive difference favours LAU-7b, a negative difference favours placebo.|Primary analysis of the treatment effect at the Week 24 visit on the intent to treat population (ITT) Null hypothesis is no treatment difference||2.3828|-0.8397|0.3449
72402219|NCT01480076|144311666|SUPERIORITY_OR_OTHER||least squares mean|3.0|STANDARD_ERROR_OF_MEAN|0.89||0.0009|TWO_SIDED||||||mixed effect model|||Overall, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MCS score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0009
72402220|NCT01480076|144311666|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 3, Responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MCS score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
72402221|NCT01480076|144311666|SUPERIORITY_OR_OTHER|||||||0.5542|||||||mixed effect model|||Month 3, Non-responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MCS score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.5542
72402222|NCT01480076|144311666|SUPERIORITY_OR_OTHER||least squares mean|4.8|STANDARD_ERROR_OF_MEAN|0.99|<|0.0001|TWO_SIDED||||||mixed effect model|||Month 3, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MCS score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
72402223|NCT01480076|144311666|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 6, Responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MCS score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
72567205|NCT03265288|144665355|SUPERIORITY||Least square means difference|1.0053||||0.0667|TWO_SIDED|95.0|-0.07|2.0807||alpha is set to 0.05|Mixed Model for Repeated Measures||A positive difference favours LAU-7b, a negative difference favours placebo.|Analysis of the overall treatment effect from baseline through Week 24 in the intent to treat population (ITT), Null hypothesis is no treatment difference||2.0807|-0.0700|0.0667
72402224|NCT01480076|144311666|SUPERIORITY_OR_OTHER|||||||0.581|||||||mixed effect model|||Month 6, Non-responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MCS score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.5810
72402225|NCT01480076|144311666|SUPERIORITY_OR_OTHER||least squares mean|2.7|STANDARD_ERROR_OF_MEAN|1.08||0.014|TWO_SIDED||||||mixed effect model|||Month 6, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MCS score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0140
72402226|NCT01480076|144311666|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 9, Responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MCS score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
72402227|NCT01480076|144311666|SUPERIORITY_OR_OTHER|||||||0.4138|||||||mixed effect model|||Month 9, Non-responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MCS score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.4138
72402228|NCT01480076|144311666|SUPERIORITY_OR_OTHER||least squares mean|1.3|STANDARD_ERROR_OF_MEAN|1.19||0.274|TWO_SIDED||||||mixed effect model|||Month 9, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MCS score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.2740
72402229|NCT01480076|144311666|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 12, Responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MCS score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
72483056|NCT01008696|144492964|SUPERIORITY_OR_OTHER|||||||0.6295||||||Change at Day 57: Hoarseness|Wilcoxon rank-sum test|||||||0.6295
72483057|NCT01008696|144492964|SUPERIORITY_OR_OTHER|||||||0.5335||||||Change at Day 57: Dysphagia|Wilcoxon rank-sum test|||||||0.5335
72483058|NCT01008696|144492964|SUPERIORITY_OR_OTHER|||||||0.8068||||||Change at Day 57: Abdominal distension|Wilcoxon rank-sum test|||||||0.8068
72483059|NCT01008696|144492964|SUPERIORITY_OR_OTHER|||||||0.568||||||Change at Day 57: Bloating|Wilcoxon rank-sum test|||||||0.5680
72483060|NCT01008696|144492964|SUPERIORITY_OR_OTHER|||||||0.5913||||||Change at Day 57: Post-prandial discomfort|Wilcoxon rank-sum test|||||||0.5913
72483061|NCT01008696|144492964|SUPERIORITY_OR_OTHER|||||||0.5566||||||Change at Day 57: Early satiety|Wilcoxon rank-sum test|||||||0.5566
72483062|NCT01008696|144492964|SUPERIORITY_OR_OTHER|||||||0.7047||||||Change at Day 57: Nausea|Wilcoxon rank-sum test|||||||0.7047
72483063|NCT01008696|144492964|SUPERIORITY_OR_OTHER|||||||0.3654||||||Change at Day 57: Vomitting|Wilcoxon rank-sum test|||||||0.3654
72483064|NCT01008696|144492964|SUPERIORITY_OR_OTHER|||||||0.531||||||Change at Day 57: Belching|Wilcoxon rank-sum test|||||||0.5310
72483065|NCT01008696|144492965|SUPERIORITY_OR_OTHER|||||||0.5032|||||||Wilcoxon rank-sum test|||||||0.5032
72483066|NCT01067326|144492999|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||t-test, 2 sided|||Change in EPCs from baseline to 4 months||||0.02
72402230|NCT01480076|144311666|SUPERIORITY_OR_OTHER|||||||0.6453|||||||mixed effect model|||Month 12, Non-responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MCS score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.6453
72567206|NCT03265288|144665355|SUPERIORITY||Least square means difference|1.2258||||0.0486|TWO_SIDED|95.0|0.0078|2.4438||alpha is set to 0.05|Mixed Model for Repeated Measures||A positive difference favours LAU-7b, a negative difference favours placebo.|Secondary analysis of the overall treatment effect from baseline through Week 24 on the per protocol population (PP), null hypothesis is no treatment difference||2.4438|0.0078|0.0486
72567207|NCT03265288|144665355|SUPERIORITY||Least square means difference|2.6628||||0.0687|TWO_SIDED|95.0|-0.2069|5.5325||alpha is set to 0.05|Mixed Model for Repeated Measures||A positive difference favours LAU-7b, a negative difference favours placebo.|"Secondary analysis of treatment effect at the Week 24 visit for stratification factor ppFEV1 (\<70% or ≥70%) in intent to treat population (ITT), null hypothesis is no treatment difference.~Here presented is the analysis for subgroup ≥70%, n=29 (LAU-7b), n=27 (Placebo)"||5.5325|-0.2069|0.0687
72567208|NCT03265288|144665355|SUPERIORITY||Least square means difference|1.391||||0.236|TWO_SIDED|95.0|-0.922|3.7041||alpha is set to 0.05|Mixed Model for Repeated Measures||A positive difference favours LAU-7b, a negative difference favours placebo.|"Secondary analysis of treatment effect at the Week 24 visit for stratification factor co-administration of CFTR modulator (yes/no) in intent to treat population (ITT), null hypothesis is no treatment difference.~Here presented is the analysis for subgroup receiving CFTR modulators, n=41 (LAU-7b), n=46 (Placebo)"||3.7041|-0.9220|0.236
72567209|NCT03265288|144665355|SUPERIORITY||Least square means difference|1.1302||||0.5323|TWO_SIDED|95.0|-2.4447|4.7052||alpha is set to 0.05|Mixed Model for Repeated Measures||A positive difference favours LAU-7b, a negative difference favours placebo.|"Secondary analysis of treatment effect at the Week 24 visit for à priori defined subgroup co-administration of ETI - elexacaftor/tezacaftor/ivacaftor (yes/no) in intent to treat population (ITT), null hypothesis is no treatment difference.~Here presented is the analysis for subgroup receiving ETI, n=18 (LAU-7b), n=23 (Placebo)"||4.7052|-2.4447|0.5323
72483067|NCT01067326|144493000|SUPERIORITY_OR_OTHER|||||||0.006||95.0|||||t-test, 2 sided|||Difference in systolic blood pressure from baseline to 4 months.||||.006
72483068|NCT01067326|144493001|SUPERIORITY_OR_OTHER|||||||0.04||95.0|||||t-test, 2 sided|||Difference in diastolic blood pressure from baseline to 4 months.||||0.04
72483069|NCT01067326|144493002|SUPERIORITY_OR_OTHER|||||||0.94||95.0|||||t-test, 2 sided|||P-value for intergroup comparison of change from baseline to month 4||||0.94
72483070|NCT00696761|144493003|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05|||||||Kruskal-Wallis|||||||<0.05
72483071|NCT00696761|144493004|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05||95.0|||||Kruskal-Wallis|||The Kruskal-Wallis test, analysis of variance, and the Wilcoxon signed rank-sum test were used to compare changes from baseline to endpoint after treatment.||||<0.05
72511520|NCT01515306|144553614|SUPERIORITY_OR_OTHER_LEGACY||Ratio of Geo LS means|0.97|||||TWO_SIDED|90.0|0.83|1.13|||Mixed Models Analysis|Ratio of Geo LS mean is Cmax of Cycle 2/Cycle 1.||||1.13|0.83|
72511521|NCT02435277|144553634|OTHER|||||||0.0475||||||Total daily dose is twice the respective dose, Pairwise Comparison using Control as the Reference Group|ANCOVA|||Mixed Model Inferential Statistical Analysis of HbA1c change from day 1-day 84 Evaluable Population (n=43)||||0.0475
72511522|NCT02435277|144553634|OTHER|||||||0.0912|||||||ANCOVA|||||||0.0912
72511523|NCT02435277|144553634|OTHER|||||||0.0458|||||||ANCOVA|||||||0.0458
72511524|NCT02435277|144553635|OTHER|||||||0.26||||||Total daily dose is twice the respective dose Pairwise Comparison using Treatment D as the Reference Group|ANCOVA|||Mixed Model Inferential Statistical Analysis of Fssting Plasma Glucose change from day 1-day 84 in Evaluable Population (n=43)||||0.26
72511525|NCT02435277|144553635|OTHER|||||||0.0083|||||||ANCOVA|||||||0.0083
72511526|NCT02435277|144553635|OTHER|||||||0.0317|||||||ANCOVA|||||||0.0317
72511527|NCT00958308|144553638|SUPERIORITY_OR_OTHER||||||=|0.02|||||||Fisher Exact|||The sample size calculation was based on the incidence of AAD. A total of 255 patients was enrolled in order to obtain at least the required 225 evaluable patients.With expected AAD rates of at most 15% - 25% in the treatment groups; and 25% - 35% in the placebo group, these numbers were sufficient to detect the difference in the incidence of AAD between either of the treatment groups vs. placebo with a minimum of 86% statistical power.||||=0.02
72511528|NCT02227329|144553645|SUPERIORITY|||||||0.17|||||||t-test, 2 sided|||||||0.17
72511529|NCT06704178|144553681|SUPERIORITY|||||||0.488445|||||||Multiple t-tests|||||||0.488445
72511530|NCT06704178|144553682|SUPERIORITY|Between-group comparison.||||||0.98317||||||Between-group comparison.|t-test, 2 sided|||||||0.98317
72511531|NCT06704178|144553683|SUPERIORITY|||||||0.98317|||||||t-test, 2 sided|||||||0.98317
72511532|NCT06704178|144553684|SUPERIORITY|||||||0.919209|||||||t-test, 2 sided|||||||0.919209
72511533|NCT06704178|144553685|SUPERIORITY|||||||0.919209|||||||t-test, 2 sided|||||||0.919209
72511534|NCT06704178|144553686|SUPERIORITY|||||||0.954882||||||Comparison at Month 2|t-test, 2 sided|||||||0.954882
72511535|NCT06704178|144553686|SUPERIORITY|||||||0.246176||||||Comparison at Month 4|t-test, 2 sided|||||||0.246176
72511536|NCT06704178|144553686|SUPERIORITY|||||||0.954882||||||Comparison at Month 6|t-test, 2 sided|||||||0.954882
72511537|NCT06704178|144553687|SUPERIORITY|||||||0.483382||||||Comparison at Month 2|t-test, 2 sided|||||||0.483382
72511538|NCT06704178|144553687|SUPERIORITY|||||||0.483382||||||Comparison at Month 4|t-test, 2 sided|||||||0.483382
72511539|NCT06704178|144553687|SUPERIORITY|||||||0.726742||||||Comparison at Month 6|t-test, 2 sided|||||||0.726742
72511540|NCT06704178|144553688|SUPERIORITY|||||||0.999216||||||Comparison at Month 1|t-test, 2 sided|||||||0.999216
72511541|NCT06704178|144553688|SUPERIORITY|||||||0.999779||||||Comparison at Month 2|t-test, 2 sided|||||||0.999779
72511542|NCT06704178|144553688|SUPERIORITY|||||||0.559556||||||Comparison at Month 3|t-test, 2 sided|||||||0.559556
72511543|NCT06704178|144553688|SUPERIORITY|||||||0.999984||||||Comparison at Month 4|t-test, 2 sided|||||||0.999984
72511544|NCT06704178|144553688|SUPERIORITY|||||||0.952545||||||Comparison at Month 5|t-test, 2 sided|||||||0.952545
72511545|NCT06704178|144553688|SUPERIORITY|||||||0.998367||||||Comparison at Month 6|t-test, 2 sided|||||||0.998367
72511546|NCT06704178|144553689|SUPERIORITY|||||||0.999851||||||Comparison at Month 1|t-test, 2 sided|||||||0.999851
72511547|NCT06704178|144553689|SUPERIORITY|||||||0.999779||||||Comparison at Month 2|t-test, 2 sided|||||||0.999779
72402231|NCT01480076|144311666|SUPERIORITY_OR_OTHER||least squares mean|3.1|STANDARD_ERROR_OF_MEAN|1.18||0.009|TWO_SIDED||||||mixed effect model|||Month 12, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MCS score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0090
72402232|NCT01480076|144311667|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Overall, Responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MSIS-29 physical score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
72402233|NCT01480076|144311667|SUPERIORITY_OR_OTHER|||||||0.2475|||||||mixed effect model|||Overall, Non-responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MSIS-29 physical score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.2475
72402234|NCT01480076|144311667|SUPERIORITY_OR_OTHER||least squares mean|-8.2|STANDARD_ERROR_OF_MEAN|1.66|<|0.0001|TWO_SIDED||||||mixed effect model|||Overall, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MSIS-29 physical score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
72402235|NCT01480076|144311667|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 3, Responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MSIS-29 physical score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
72483072|NCT01603082|144493031|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-159.1|STANDARD_ERROR_OF_MEAN|17.9|<|0.001|TWO_SIDED|95.0|-194.7|-123.5|||t-test, 2 sided||Ticagrelor minus clopidogrel.|||-123.5|-194.7|<0.001
72483073|NCT01603082|144493032|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-20.4|STANDARD_ERROR_OF_MEAN|15.2||0.182|TWO_SIDED|95.0|-50.5|9.7|||t-test, 2 sided||Ticagrelor minus clopidogrel.|Analysis at 0.5 hours after the loading dose||9.7|-50.5|0.182
72483074|NCT01603082|144493032|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-158.5|STANDARD_ERROR_OF_MEAN|15.5|<|0.001|TWO_SIDED|95.0|-189.4|-127.7|||t-test, 2 sided||Ticagrelor minus clopidogrel.|Analysis at 8 hours after the loading dose.||-127.7|-189.4|<0.001
72483075|NCT01603082|144493032|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-43.6|STANDARD_ERROR_OF_MEAN|16.5||0.01|TWO_SIDED|95.0|-76.5|-10.7|||t-test, 2 sided||Ticagrelor minus clopidogrel.|Analysis at end of PCI.||-10.7|-76.5|0.010
72483076|NCT00852592|144493033|SUPERIORITY_OR_OTHER||||||=|0.005|||||||ANOVA|||||||=0.005
72567210|NCT03265288|144665357|SUPERIORITY||Odds Ratio (OR)|0.5036||||0.1047|TWO_SIDED|95.0|0.2199|1.1532||alpha is set to 0.05|Regression, Logistic||Odds ratio \< 1 means lower odds of normalization with LAU-7b, odds ratio \> 1 means higher odds of normalization with LAU-7b|Highest normalization of Arachidonic Acid (AA) during treatment Intent to treat population (ITT), null hypothesis is no treatment effect||1.1532|0.2199|0.1047
72483077|NCT00852592|144493034|SUPERIORITY_OR_OTHER||||||=|0.004|||||||ANOVA|||||||=0.004
72483078|NCT00986440|144493042|SUPERIORITY||Z statistic for difference|3.92|||<|0.0001|TWO_SIDED||||||2-sided P value for z test|||||||<0.0001
72483079|NCT00986440|144493042|SUPERIORITY||Hazard Ratio, log|-0.41|||||TWO_SIDED|||||||||||||
72483080|NCT00986440|144493043|SUPERIORITY|||||||0.038|||||||Log Rank|||||||0.0380
72567211|NCT03265288|144665357|SUPERIORITY||Odds Ratio (OR)|0.8773||||0.7596|TWO_SIDED|95.0|0.3793|2.0291||alpha is set to 0.05|Regression, Logistic||Odds ratio \< 1 means lower odds of normalization with LAU-7b, odds ratio \> 1 means higher odds of normalization with LAU-7b|Highest normalization of Docosahexaenoic Acid (DHA) during treatment Intent to treat population (ITT, null hypothesis is no treatment effect||2.0291|0.3793|0.7596
72567212|NCT03265288|144665357|SUPERIORITY||Odds Ratio (OR)|1.0532||||0.8852|TWO_SIDED|95.0|0.5209|2.1296||alpha is set to 0.05|Regression, Logistic||Odds ratio \< 1 means lower odds of normalization with LAU-7b, odds ratio \> 1 means higher odds of normalization with LAU-7b|Highest normalization of AA/DHA ratio during treatment Intent to treat population (ITT), null hypothesis is no treatment effect||2.1296|0.5209|0.8852
72567213|NCT03265288|144665360|SUPERIORITY|||||||0.3025|||||||Log Rank|||||||0.3025
72483081|NCT00986440|144493043|SUPERIORITY|||||||0.1773|||||||Peto-Peto-Prentice|||||||0.1773
72483082|NCT00986440|144493043|SUPERIORITY|||||||0.2844|||||||Wilcoxon (Mann-Whitney)|||||||0.2844
72483083|NCT00986440|144493043|SUPERIORITY|||||||0.114|||||||Tarone-Ware|||||||0.1140
72483084|NCT00986440|144493044|SUPERIORITY|||||||0.1213|||||||Log Rank|||||||0.1213
72483085|NCT00372385|144493048|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.758||||0.0026|TWO_SIDED|95.0|1.424|5.34|||Regression, Logistic|||||5.340|1.424|0.0026
72483086|NCT00372385|144493048|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.709||||0.959|TWO_SIDED|95.0|0.91|3.212|||Regression, Logistic|||||3.212|0.910|0.959
72483087|NCT00372385|144493048|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.589||||0.1089|TWO_SIDED|95.0|0.309|1.125|||Regression, Logistic|||||1.125|0.309|0.1089
72483088|NCT00372385|144493049|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.632||||0.0041|TWO_SIDED|95.0|1.359|5.097|||Regression, Logistic|||||5.097|1.359|0.0041
72483089|NCT00372385|144493049|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.623||||0.1324|TWO_SIDED|95.0|0.864|3.05|||Regression, Logistic|||||3.050|0.864|0.1324
72483090|NCT00372385|144493049|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.591||||0.1099|TWO_SIDED|95.0|0.311|1.126|||Regression, Logistic|||||1.126|0.311|0.1099
72483091|NCT01699789|144493054|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.74|||||TWO_SIDED|95.0|0.57|0.95||||||Intent-to-treat, comparative-effectiveness analyses with intervention status as the independent variable, using a logistic regression model adjusted for baseline and covariates, and accounted for the design effect of the cluster randomization. We weighted data for 1,018 clients to characteristics of the eligible sample, with item-level imputation for missing data and wave-level imputation for missing surveys. Weights account for non-enrollment among eligible clients and attrition.||0.95|0.57|
72511548|NCT06704178|144553689|SUPERIORITY|||||||0.999801|||||||t-test, 2 sided|||||||0.999801
72511549|NCT06704178|144553689|SUPERIORITY|||||||0.999984||||||Comparison at Month 4|t-test, 2 sided|||||||0.999984
72511550|NCT06704178|144553689|SUPERIORITY|||||||0.993223||||||Comparison at Month 5|t-test, 2 sided|||||||0.993223
72511551|NCT06704178|144553689|SUPERIORITY|||||||0.999567||||||Comparison at Month 6|t-test, 2 sided|||||||0.999567
72511552|NCT06704178|144553690|SUPERIORITY|||||||0.999851||||||Comparison at Month 1|t-test, 2 sided|||||||0.999851
72511553|NCT06704178|144553690|SUPERIORITY|||||||0.999838||||||Comparison at Month 2|t-test, 2 sided|||||||0.999838
72511554|NCT06704178|144553690|SUPERIORITY|||||||0.991697||||||Comparison at Month 3|t-test, 2 sided|||||||0.991697
72511555|NCT06704178|144553690|SUPERIORITY|||||||0.999984||||||Comparison at Month 4|t-test, 2 sided|||||||0.999984
72511556|NCT06704178|144553690|SUPERIORITY|||||||0.581904||||||Comparison at Month 5|t-test, 2 sided|||||||0.581904
72511557|NCT06704178|144553690|SUPERIORITY|||||||0.999866||||||Comparison at Month 6|t-test, 2 sided|||||||0.999866
72511558|NCT06704178|144553691|SUPERIORITY|||||||0.999835||||||Comparison at Month 1|t-test, 2 sided|||||||0.999835
72511559|NCT06704178|144553691|SUPERIORITY|||||||0.962016||||||Comparison at Month 2|t-test, 2 sided|||||||0.962016
72511560|NCT06704178|144553691|SUPERIORITY|||||||0.995044||||||Comparison at Month 3|t-test, 2 sided|||||||0.995044
72511561|NCT06704178|144553691|SUPERIORITY|||||||0.998665||||||Comparison at Month 4|t-test, 2 sided|||||||0.998665
72511562|NCT06704178|144553691|SUPERIORITY|||||||0.999816||||||Comparison at Month 5|t-test, 2 sided|||||||0.999816
72511563|NCT06704178|144553691|SUPERIORITY|||||||0.999567||||||Comparison at Month 6|t-test, 2 sided|||||||0.999567
72511564|NCT06704178|144553692|SUPERIORITY|||||||0.999851||||||Comparison at Month 1|t-test, 2 sided|||||||0.999851
72511565|NCT06704178|144553692|SUPERIORITY|||||||0.999524||||||Comparison at Month 2|t-test, 2 sided|||||||0.999524
72511566|NCT06704178|144553692|SUPERIORITY|||||||0.576782||||||Comparison at Month 3|t-test, 2 sided|||||||0.576782
72511567|NCT06704178|144553692|SUPERIORITY|||||||0.772865||||||Comparison at Month 4|t-test, 2 sided|||||||0.772865
72511568|NCT06704178|144553692|SUPERIORITY|||||||0.91384||||||Comparison at Month 5|t-test, 2 sided|||||||0.91384
72511569|NCT06704178|144553692|SUPERIORITY|||||||0.992841||||||Comparison at Month 6|t-test, 2 sided|||||||0.992841
72511570|NCT06704178|144553693|SUPERIORITY|||||||0.999732||||||Comparison at Month 1|t-test, 2 sided|||||||0.999732
72511571|NCT06704178|144553693|SUPERIORITY|||||||0.999779||||||Comparison at Month 2|t-test, 2 sided|||||||0.999779
72511572|NCT06704178|144553693|SUPERIORITY|||||||0.999801||||||Comparison at Month 3|t-test, 2 sided|||||||0.999801
72511573|NCT06704178|144553693|SUPERIORITY||||||>|0.999999||||||Comparison at Month 4|t-test, 2 sided|||||||>0.999999
72511574|NCT06704178|144553693|SUPERIORITY|||||||0.999816||||||Comparison at Month 5|t-test, 2 sided|||||||0.999816
72511575|NCT06704178|144553693|SUPERIORITY||||||>|0.999999||||||Comparison at Month 6|t-test, 2 sided|||||||>0.999999
72511576|NCT06704178|144553694|SUPERIORITY|||||||0.999851||||||Comparison at Month 1|t-test, 2 sided|||||||0.999851
72511577|NCT06704178|144553694|SUPERIORITY|||||||0.999779||||||Comparison at Month 2|t-test, 2 sided|||||||0.999779
72511578|NCT06704178|144553694|SUPERIORITY|||||||0.998326||||||Comparison at Month 3|t-test, 2 sided|||||||0.998326
72511579|NCT06704178|144553694|SUPERIORITY|||||||0.998665||||||Comparison at Month 4|t-test, 2 sided|||||||0.998665
72511580|NCT06704178|144553694|SUPERIORITY|||||||0.999816||||||Comparison at Month 5|t-test, 2 sided|||||||0.999816
72511581|NCT06704178|144553694|SUPERIORITY|||||||0.998846||||||Comparison at Month 6|t-test, 2 sided|||||||0.998846
72511582|NCT06704178|144553695|SUPERIORITY|||||||0.999387||||||Comparison at Month 1|t-test, 2 sided|||||||0.999387
72511583|NCT06704178|144553695|SUPERIORITY|||||||0.999779||||||Comparison at Month 2|t-test, 2 sided|||||||0.999779
72511584|NCT06704178|144553695|SUPERIORITY||||||>|0.999999||||||Comparison at Month 3|t-test, 2 sided|||||||>0.999999
72511585|NCT06704178|144553695|SUPERIORITY|||||||0.999984||||||Comparison at Month 4|t-test, 2 sided|||||||0.999984
72511586|NCT06704178|144553695|SUPERIORITY|||||||0.999816||||||Comparison at Month 5|t-test, 2 sided|||||||0.999816
72511587|NCT06704178|144553695|SUPERIORITY|||||||0.998367||||||Comparison at Month 6|t-test, 2 sided|||||||0.998367
72511588|NCT06704178|144553696|SUPERIORITY|||||||0.999975||||||Comparison at Month 1|t-test, 2 sided|||||||0.999975
72511589|NCT06704178|144553696|SUPERIORITY|||||||0.999779||||||Comparison at Month 2|t-test, 2 sided|||||||0.999779
72511590|NCT06704178|144553696|SUPERIORITY|||||||0.999801||||||Comparison at Month 3|t-test, 2 sided|||||||0.999801
72511591|NCT06704178|144553696|SUPERIORITY|||||||0.999984||||||Comparison at Month 4|t-test, 2 sided|||||||0.999984
72511592|NCT06704178|144553696|SUPERIORITY|||||||0.960874||||||Comparison at Month 5|t-test, 2 sided|||||||0.960874
72511593|NCT06704178|144553696|SUPERIORITY|||||||0.999567||||||Comparison at Month 6|t-test, 2 sided|||||||0.999567
72511594|NCT06704178|144553697|SUPERIORITY|||||||0.981906||||||Comparison at Month 1|t-test, 2 sided|||||||0.981906
72511595|NCT06704178|144553697|SUPERIORITY|||||||0.945027||||||Comparison at Month 2|t-test, 2 sided|||||||0.945027
72511596|NCT06704178|144553697|SUPERIORITY|||||||0.767795||||||Comparison at Month 3|t-test, 2 sided|||||||0.767795
72511597|NCT06704178|144553697|SUPERIORITY|||||||0.996139||||||Comparison at Month 4|t-test, 2 sided|||||||0.996139
72511598|NCT06704178|144553697|SUPERIORITY|||||||0.952378||||||Comparison at Month 5|t-test, 2 sided|||||||0.952378
72511599|NCT06704178|144553697|SUPERIORITY|||||||0.998846||||||Comparison at Month 6|t-test, 2 sided|||||||0.998846
72511600|NCT06704178|144553698|SUPERIORITY|||||||0.55783||||||Comparison at Month 1|t-test, 2 sided|||||||0.55783
72511601|NCT06704178|144553698|SUPERIORITY|||||||0.987949||||||Comparison at Month 2|t-test, 2 sided|||||||0.987949
72511602|NCT06704178|144553698|SUPERIORITY|||||||0.576782||||||Comparison at Month 3|t-test, 2 sided|||||||0.576782
72511603|NCT06704178|144553698|SUPERIORITY|||||||0.998665||||||Comparison at Month 4|t-test, 2 sided|||||||0.998665
72511604|NCT06704178|144553698|SUPERIORITY|||||||0.989226||||||Comparison at Month 5|t-test, 2 sided|||||||0.989226
72511605|NCT06704178|144553698|SUPERIORITY|||||||0.999567||||||Comparison at Month 6|t-test, 2 sided|||||||0.999567
72511606|NCT06704178|144553699|SUPERIORITY|||||||0.795476||||||Comparison at Month 1|t-test, 2 sided|||||||0.795476
72511607|NCT06704178|144553699|SUPERIORITY|||||||0.977286||||||Comparison at Month 2|t-test, 2 sided|||||||0.977286
72511608|NCT06704178|144553699|SUPERIORITY|||||||0.559556||||||Comparison at Month 3|t-test, 2 sided|||||||0.559556
72483092|NCT01699789|144493055|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.78|||||TWO_SIDED|95.0|0.48|1.26||||||Intent-to-treat, comparative-effectiveness analyses with intervention status as the independent variable, using a logistic regression model adjusted for baseline and covariates, and accounted for the design effect of the cluster randomization. We weighted data for 1,018 clients to characteristics of the eligible sample, with item-level imputation for missing data and wave-level imputation for missing surveys. Weights account for non-enrollment among eligible clients and attrition.||1.26|0.48|
72483093|NCT01699789|144493056|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.77|||||TWO_SIDED|95.0|0.61|0.97||||||Intent-to-treat analyses of repeated measures were developed including all participants with data at baseline, 6-month, or 12-month. Missing data were imputed. A generalized estimating equation (GEE) with a logit link function was used with adjustment for covariates.|In an analysis of change from baseline in likelihood of Poor Mental Health Quality of Life, CEP showed a significant advantage at 6 months, but not at 12 months.|0.97|0.61|
72483094|NCT01699789|144493057|SUPERIORITY||Odds Ratio (OR)|1.3|||||TWO_SIDED|95.0|0.7|2.3||||||Intent-to-treat, comparative-effectiveness analyses with intervention status as the independent variable, using logistic regression model adjusted for baseline and covariates, and accounted for the design effect of the cluster randomization. We weighted data for 980 clients at 3 years to characteristics of the eligible sample, with item-level imputation for missing data and wave-level imputation for missing surveys. Weights account for non-enrollment among eligible clients and attrition.||2.3|0.7|
72483095|NCT01699789|144493058|SUPERIORITY||Odds Ratio (OR)|1.0|||||TWO_SIDED|95.0|0.6|1.7||||||Intent-to-treat, comparative-effectiveness analyses with intervention status as the independent variable, using a logistic regression model adjusted for baseline and covariates, and accounted for the design effect of the cluster randomization. We weighted data for 980 clients at 3 years to characteristics of the eligible sample, with item-level imputation for missing data and wave-level imputation for missing surveys. Weights account for non-enrollment among eligible clients and attrition.||1.7|0.6|
72483096|NCT01699789|144493059|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.75|||||TWO_SIDED|95.0|1.19|2.59||||||Intent-to-treat, comparative-effectiveness analyses with intervention status as the independent variable, using a logistic regression model adjusted for baseline and covariates, and accounted for the design effect of the cluster randomization. We weighted data for 1,018 clients to characteristics of the eligible sample, with item-level imputation for missing data and wave-level imputation for missing surveys. Weights account for non-enrollment among eligible clients and attrition.||2.59|1.19|
72483097|NCT01699789|144493060|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.45|||||TWO_SIDED|95.0|1.03|2.04||||||Intent-to-treat, comparative-effectiveness analyses with intervention status as the independent variable, using a logistic regression model adjusted for baseline and covariates, and accounted for the design effect of the cluster randomization. We weighted data for 1,018 clients to characteristics of the eligible sample, with item-level imputation for missing data and wave-level imputation for missing surveys. Weights account for non-enrollment among eligible clients and attrition.||2.04|1.03|
72483098|NCT01699789|144493061|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.5|||||TWO_SIDED|95.0|1.14|1.98||||||Intent-to-treat, comparative-effectiveness analyses with intervention status as the independent variable, using a logistic regression model adjusted for baseline and covariates, and accounted for the design effect of the cluster randomization. We weighted data for 1,018 clients to characteristics of the eligible sample, with item-level imputation for missing data and wave-level imputation for missing surveys. Weights account for non-enrollment among eligible clients and attrition.||1.98|1.14|
72511609|NCT06704178|144553699|SUPERIORITY|||||||0.997753||||||Comparison at Month 4|t-test, 2 sided|||||||0.997753
72511610|NCT06704178|144553699|SUPERIORITY|||||||0.952378||||||Comparison at Month 5|t-test, 2 sided|||||||0.952378
72511611|NCT06704178|144553699|SUPERIORITY|||||||0.988108||||||Comparison at Month 6|t-test, 2 sided|||||||0.988108
72511612|NCT06704178|144553700|SUPERIORITY|||||||0.995367||||||Comparison at Month 1|t-test, 2 sided|||||||0.995367
72511613|NCT06704178|144553700|SUPERIORITY|||||||0.999779||||||Comparison at Month 2|t-test, 2 sided|||||||0.999779
72511614|NCT06704178|144553700|SUPERIORITY|||||||0.974102||||||Comparison at Month 3|t-test, 2 sided|||||||0.974102
72511615|NCT06704178|144553700|SUPERIORITY|||||||0.998665||||||Comparison at Month 4|t-test, 2 sided|||||||0.998665
72511616|NCT06704178|144553700|SUPERIORITY|||||||0.999816||||||Comparison at Month 5|t-test, 2 sided|||||||0.999816
72511617|NCT06704178|144553700|SUPERIORITY|||||||0.999567||||||Comparison at Month 6|t-test, 2 sided|||||||0.999567
72511618|NCT06704178|144553701|SUPERIORITY|||||||0.882016||||||Comparison at Month 1|t-test, 2 sided|||||||0.882016
72511619|NCT06704178|144553701|SUPERIORITY|||||||0.860406||||||Comparison at Month 2|t-test, 2 sided|||||||0.860406
72511620|NCT06704178|144553701|SUPERIORITY|||||||0.958944||||||Comparison at Month 3|t-test, 2 sided|||||||0.958944
72511621|NCT06704178|144553701|SUPERIORITY|||||||0.998816||||||Comparison at Month 4|t-test, 2 sided|||||||0.998816
72511622|NCT06704178|144553701|SUPERIORITY|||||||0.989226||||||Comparison at Month 5|t-test, 2 sided|||||||0.989226
72511623|NCT06704178|144553701|SUPERIORITY|||||||0.999296||||||Comparison at Month 6|t-test, 2 sided|||||||0.999296
72511624|NCT06704178|144553702|SUPERIORITY|||||||0.999975||||||Comparison at Month 1.|t-test, 2 sided|||||||0.999975
72511625|NCT06704178|144553702|SUPERIORITY|||||||0.977286||||||Comparison at Month 2|t-test, 2 sided|||||||0.977286
72511626|NCT06704178|144553702|SUPERIORITY|||||||0.999||||||Comparison at Month 3.|t-test, 2 sided|||||||0.999
72511627|NCT06704178|144553702|SUPERIORITY|||||||0.999984||||||Comparison at Month 4.|t-test, 2 sided|||||||0.999984
72511628|NCT06704178|144553702|SUPERIORITY|||||||0.986557||||||Comparison at Month 5.|t-test, 2 sided|||||||0.986557
72511629|NCT06704178|144553702|SUPERIORITY|||||||0.998367||||||Comparison at Month 6.|t-test, 2 sided|||||||0.998367
72511630|NCT06704178|144553703|SUPERIORITY|||||||0.999851||||||Comparison at Month 1.|t-test, 2 sided|||||||0.999851
72511631|NCT06704178|144553703|SUPERIORITY|||||||0.999779||||||Comparison at Month 2.|t-test, 2 sided|||||||0.999779
72511632|NCT06704178|144553703|SUPERIORITY|||||||0.999801||||||Comparison at Month 3.|t-test, 2 sided|||||||0.999801
72511633|NCT06704178|144553703|SUPERIORITY|||||||0.998467||||||Comparison at Month 4.|t-test, 2 sided|||||||0.998467
72483099|NCT01699789|144493062|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.61|||||TWO_SIDED|95.0|0.38|0.96||||||Intent-to-treat, comparative-effectiveness analyses with intervention status as the independent variable, using a logistic regression model adjusted for baseline and covariates, and accounted for the design effect of the cluster randomization. We weighted data for 1,018 clients to characteristics of the eligible sample, with item-level imputation for missing data and wave-level imputation for missing surveys. Weights account for non-enrollment among eligible clients and attrition.||0.96|0.38|
72483100|NCT01699789|144493063|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.09|||||TWO_SIDED|95.0|0.69|1.7||||||Intent-to-treat, comparative-effectiveness analyses with intervention status as the independent variable, using a logistic regression model adjusted for baseline and covariates, and accounted for the design effect of the cluster randomization. We weighted data for 1,018 clients to characteristics of the eligible sample, with item-level imputation for missing data and wave-level imputation for missing surveys. Weights account for non-enrollment among eligible clients and attrition.||1.70|0.69|
72483101|NCT01699789|144493064|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.59|||||TWO_SIDED|95.0|0.32|1.09||||||Adjusted analyses used multiply imputed data (N= 249), weighted for eligible sample for enrollment; logistic regression model adjusted for baseline and covariates and accounted for the design effect of the cluster randomization.||1.09|0.32|
72483102|NCT01699789|144493065|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.51|||||TWO_SIDED|95.0|0.28|0.95||||||Intent-to-treat, comparative-effectiveness analyses with intervention status as the independent variable, using a logistic regression model adjusted for baseline and covariates, and accounted for the design effect of the cluster randomization. We weighted data for 1,018 clients to characteristics of the eligible sample, with item-level imputation for missing data and wave-level imputation for missing surveys. Weights account for non-enrollment among eligible clients and attrition.||0.95|0.28|
72483103|NCT01699789|144493066|SUPERIORITY||Odds Ratio (OR)|0.34|||||TWO_SIDED|95.0|0.14|0.88||||||Intent-to-treat, comparative-effectiveness analyses with intervention status as the independent variable, using a logistic regression model adjusted for baseline and covariates, and accounted for the design effect of the cluster randomization. We weighted data for 1,018 clients to characteristics of the eligible sample, with item-level imputation for missing data and wave-level imputation for missing surveys. Weights account for non-enrollment among eligible clients and attrition.||0.88|0.14|
72483104|NCT01699789|144493067|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.81|||||TWO_SIDED|95.0|0.52|1.25|||||Median cut point for baseline variable.|Intent-to-treat, comparative-effectiveness analyses with intervention status as the independent variable, using a logistic regression model adjusted for baseline and covariates, and accounted for the design effect of the cluster randomization. We weighted data for 1,018 clients to characteristics of the eligible sample, with item-level imputation for missing data and wave-level imputation for missing surveys. Weights account for non-enrollment among eligible clients and attrition.||1.25|0.52|
72483105|NCT01699789|144493068|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.99|||||TWO_SIDED|95.0|0.69|1.41||||||Intent-to-treat, comparative-effectiveness analyses with intervention status as the independent variable, using a logistic regression model adjusted for baseline and covariates, and accounted for the design effect of the cluster randomization. We weighted data for 1,018 clients to characteristics of the eligible sample, with item-level imputation for missing data and wave-level imputation for missing surveys. Weights account for non-enrollment among eligible clients and attrition||1.41|0.69|
72483106|NCT01699789|144493069|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.01|||||TWO_SIDED|95.0|0.7|1.46||||||Intent-to-treat, comparative-effectiveness analyses with intervention status as the independent variable, using logistic regression model adjusted for baseline and covariates, and accounted for the design effect of the cluster randomization. We weighted data for 1,018 clients to characteristics of the eligible sample, with item-level imputation for missing data and wave-level imputation for missing surveys. Weights account for non-enrollment among eligible clients and attrition.||1.46|0.70|
72483107|NCT01699789|144493070|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.63|||<|0.01|TWO_SIDED|95.0|1.4|4.94|||Regression, Logistic|||Adjusted analyses used multiply imputed data (N=298), weighted for eligible sample for enrollment; logistic regression model adjusted for baseline and covariates and accounted for the design effect of the cluster randomization.||4.94|1.40|<.01
72483108|NCT01699789|144493071|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.89|||||TWO_SIDED|95.0|0.66|1.21||||||Intent-to-treat, comparative-effectiveness analyses with intervention status as the independent variable, using a generalized estimating equation logistic regression model adjusted for covariates, accounted for the design effect of the cluster randomization. We weighted data for 1,018 clients to characteristics of the eligible sample, with item-level imputation for missing data and wave-level imputation for missing surveys. Weights account for non-enrollment among eligible clients and attrition.||1.21|0.66|
72511634|NCT06704178|144553703|SUPERIORITY|||||||0.999816||||||Comparison at Month 5.|t-test, 2 sided|||||||0.999816
72511635|NCT06704178|144553703|SUPERIORITY|||||||0.998846||||||Comparison at Month 6.|t-test, 2 sided|||||||0.998846
72511636|NCT06704178|144553704|SUPERIORITY||||||>|0.999999||||||Comparison at Month 1.|t-test, 2 sided|||||||>0.999999
72511637|NCT06704178|144553704|SUPERIORITY|||||||0.999779||||||Comparison at Month 2.|t-test, 2 sided|||||||0.999779
72511638|NCT06704178|144553704|SUPERIORITY|||||||0.999801||||||Comparison at Month 3.|t-test, 2 sided|||||||0.999801
72483109|NCT01699789|144493072|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.92|||||TWO_SIDED|95.0|0.61|1.4||||||Intent-to-treat, comparative-effectiveness analyses with intervention status as the independent variable, using logistic regression model adjusted for baseline and covariates, and accounted for the design effect of the cluster randomization. We weighted data for 1,018 clients to characteristics of the eligible sample, with item-level imputation for missing data and wave-level imputation for missing surveys. Weights account for non-enrollment among eligible clients and attrition.||1.40|0.61|
72511639|NCT06704178|144553704|SUPERIORITY|||||||0.963236||||||Comparison at Month 4.|t-test, 2 sided|||||||0.963236
72511640|NCT06704178|144553704|SUPERIORITY|||||||0.999816||||||Comparison at Month 5.|t-test, 2 sided|||||||0.999816
72511641|NCT06704178|144553704|SUPERIORITY|||||||0.737995||||||Comparison at Month 6.|t-test, 2 sided|||||||0.737995
72511642|NCT06704178|144553705|SUPERIORITY|||||||0.0003||||||Within-group analysis only.|t-test, 2 sided|||||||0.0003
72511643|NCT06704178|144553706|SUPERIORITY|||||||0.2698||||||Within-group analysis only.|t-test, 2 sided|||||||0.2698
72511644|NCT06704178|144553707|SUPERIORITY|||||||0.2698||||||Within-group analysis only.|t-test, 2 sided|||||||0.2698
72483110|NCT01699789|144493073|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.65|||||TWO_SIDED|95.0|0.34|1.25||||||Intent-to-treat, comparative-effectiveness analyses with intervention status as the independent variable, using logistic regression model adjusted for baseline and covariates, and accounted for the design effect of the cluster randomization. We weighted data for 1,018 clients to characteristics of the eligible sample, with item-level imputation for missing data and wave-level imputation for missing surveys. Weights account for non-enrollment among eligible clients and attrition.||1.25|0.34|
72483111|NCT01699789|144493074|SUPERIORITY_OR_OTHER_LEGACY||Rate Ratio (RR)|0.49|||||TWO_SIDED|95.0|0.3|0.82||||||Adjusted analyses used multiply imputed data (N=553), weighted for eligible sample for enrollment; Poisson regression model adjusted for baseline and covariates and accounted for the design effect of the cluster randomization.||0.82|0.30|
72483112|NCT01699789|144493075|SUPERIORITY||Rate Ratio (RR)|2.84|||||TWO_SIDED|95.0|1.39|5.8||||||Adjusted analyses used multiply imputed data (N=588), weighted for eligible sample for enrollment; Poisson regression model adjusted for baseline status of the dependent variable and covariates and accounted for the design effect of the cluster randomization.||5.80|1.39|
72483113|NCT01699789|144493076|SUPERIORITY_OR_OTHER_LEGACY||Rate Ratio (RR)|6.2|||||TWO_SIDED|95.0|1.5|24.9||||||Adjusted analyses used multiply imputed data (N=410), weighted for eligible sample for enrollment; Poisson regression model adjusted for baseline and covariates and accounted for the design effect of the cluster randomization.||24.9|1.5|
72483114|NCT01699789|144493077|SUPERIORITY_OR_OTHER_LEGACY||Rate Ratio (RR)|0.96|||||TWO_SIDED|95.0|0.59|1.57||||||Intent-to-treat, comparative-effectiveness analyses with intervention status as the independent variable, using a Poisson regression model adjusted for baseline and covariates, and accounted for the design effect of the cluster randomization. We weighted data for 1,018 clients to characteristics of the eligible sample, with item-level imputation for missing data and wave-level imputation for missing surveys. Weights account for non-enrollment among eligible clients and attrition.||1.57|0.59|
72511645|NCT06704178|144553708|SUPERIORITY|||||||0.2137||||||Within-group analysis only.|t-test, 2 sided|||||||0.2137
72511646|NCT06704178|144553709|SUPERIORITY|||||||0.8639||||||Within-group analysis only.|t-test, 2 sided|||||||0.8639
72511647|NCT06704178|144553710|SUPERIORITY|||||||0.239||||||Within-group analysis only.|t-test, 2 sided|||||||0.239
72511648|NCT06704178|144553711|SUPERIORITY|||||||0.6088||||||Within-group analysis only.|t-test, 2 sided|||||||0.6088
72511649|NCT06704178|144553712|SUPERIORITY|||||||0.5738||||||Within-group analysis only.|t-test, 2 sided|||||||0.5738
72511650|NCT06704178|144553713|SUPERIORITY|||||||0.6088||||||Within-group analysis only.|t-test, 2 sided|||||||0.6088
72511651|NCT06704178|144553714|SUPERIORITY|||||||0.4942||||||Within-group analysis only.|t-test, 2 sided|||||||0.4942
72511652|NCT06704178|144553715|SUPERIORITY|||||||0.7419||||||Month 2 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.7419
72511653|NCT06704178|144553715|SUPERIORITY|||||||0.0033||||||Month 4 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.0033
72511654|NCT06704178|144553715|SUPERIORITY|||||||0.0219||||||Month 6 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.0219
72511655|NCT06704178|144553716|SUPERIORITY|||||||0.7708||||||Month 2 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.7708
72511656|NCT06704178|144553716|SUPERIORITY|||||||0.239||||||Month 4 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.239
72483115|NCT01699789|144493078|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.7|||||TWO_SIDED|95.0|0.4|1.22|||||When analyzed as change from baseline, CEP showed significant reductions in likelihood of behavioral health hospitalizations at 6 months (P \< 0.01) and 12 months (P \< 0.01).|Intent-to-treat, comparative-effectiveness analyses with intervention status as the independent variable, using a generalized estimating equation logistic regression model adjusted for covariates, accounted for the design effect of the cluster randomization. We weighted data for 1,018 clients to characteristics of the eligible sample, with item-level imputation for missing data and wave-level imputation for missing surveys. Weights account for non-enrollment among eligible clients and attrition.||1.22|.40|
72511657|NCT06704178|144553716|SUPERIORITY|||||||0.006||||||Month 6 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.006
72511658|NCT06704178|144553717|SUPERIORITY|||||||0.0219||||||Month 2 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.0219
72511659|NCT06704178|144553717|SUPERIORITY|||||||0.0001||||||Month 4 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.0001
72511660|NCT06704178|144553717|SUPERIORITY||||||<|0.0001||||||Month 6 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||<0.0001
72511661|NCT06704178|144553718|SUPERIORITY|||||||0.0695||||||Month 2 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.0695
72511662|NCT06704178|144553718|SUPERIORITY|||||||0.0124||||||Month 4 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.0124
72511663|NCT06704178|144553718|SUPERIORITY|||||||0.0016||||||Month 6 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.0016
72511664|NCT06704178|144553719|SUPERIORITY||||||>|0.9999||||||Month 1 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
72511665|NCT06704178|144553719|SUPERIORITY||||||>|0.9999||||||Month 2 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
72511666|NCT06704178|144553719|SUPERIORITY||||||>|0.9999||||||Month 3 versus Baseline|t-test, 2 sided|Within-group analysis only.||||||>0.9999
72511667|NCT06704178|144553719|SUPERIORITY||||||>|0.9999||||||Month 4 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
72511668|NCT06704178|144553719|SUPERIORITY||||||>|0.9999||||||Month 5 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
72511669|NCT06704178|144553719|SUPERIORITY||||||>|0.9999||||||Month 6 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
72511670|NCT06704178|144553720|SUPERIORITY||||||>|0.9999||||||Month 1 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
72511671|NCT06704178|144553720|SUPERIORITY||||||>|0.9999||||||Month 2 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
72511672|NCT06704178|144553720|SUPERIORITY||||||>|0.9999||||||Month 3 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
72402236|NCT01480076|144311667|SUPERIORITY_OR_OTHER|||||||0.2422|||||||mixed effect model|||Month 3, Non-responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MSIS-29 physical score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.2422
72402237|NCT01480076|144311667|SUPERIORITY_OR_OTHER||least squares mean|-10.9|STANDARD_ERROR_OF_MEAN|1.72|<|0.0001|TWO_SIDED||||||mixed effect model|||Month 3, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MSIS-29 physical score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
72402238|NCT01480076|144311667|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 6, Responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MSIS-29 physical score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
72483116|NCT01699789|144493079|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.05|||||TWO_SIDED|95.0|0.66|1.66||||||Intent-to-treat analyses of repeated measures were developed including all participants with data at baseline, 6-month, or 12-month. Missing data were imputed. A generalized estimating equation (GEE) with a logit link function was used with adjustment for covariates.||1.66|.66|
72483117|NCT01699789|144493080|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.03|||||TWO_SIDED|95.0|0.74|1.42||||||Intent-to-treat, comparative-effectiveness analyses with intervention status as the independent variable, using a generalized estimating equation logistic regression model adjusted for covariates, accounted for the design effect of the cluster randomization. We weighted data for 1,018 clients to characteristics of the eligible sample, with item-level imputation for missing data and wave-level imputation for missing surveys. Weights account for non-enrollment among eligible clients and attrition.||1.42|0.74|
72483118|NCT01699789|144493081|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.79|||||TWO_SIDED|95.0|0.6|1.05||||||Intent-to-treat analyses of repeated measures were developed including all participants with data at baseline, 6-month, or 12-month. Missing data were imputed. A generalized estimating equation (GEE) with a logit link function was used with adjustment for covariates.||1.05|.60|
72483119|NCT01699789|144493082|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.97|||||TWO_SIDED|95.0|0.72|1.32||||||Intent-to-treat analyses of repeated measures were developed including all participants with data at baseline, 6-month, or 12-month. Missing data were imputed. A generalized estimating equation (GEE) with a logit link function was used with adjustment for covariates.||1.32|0.72|
72483120|NCT01699789|144493083|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.87|||||TWO_SIDED|95.0|0.55|1.39||||||Intent-to-treat analyses of repeated measures were developed including all participants with data at baseline, 6-month, or 12-month. Missing data were imputed. A generalized estimating equation (GEE) with a logit link function was used with adjustment for covariates.||1.39|0.55|
72511673|NCT06704178|144553720|SUPERIORITY||||||>|0.9999||||||Month 4 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
72511674|NCT06704178|144553720|SUPERIORITY||||||>|0.9999||||||Month 5 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
72402239|NCT01480076|144311667|SUPERIORITY_OR_OTHER|||||||0.1262|||||||mixed effect model|||Month 6, Non-responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MSIS-29 physical score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.1262
72483121|NCT01699789|144493084|SUPERIORITY_OR_OTHER_LEGACY||Rate Ratio (RR)|0.91|||||TWO_SIDED|95.0|0.65|1.29||||||Intent-to-treat analyses of repeated measures were developed including all participants with data at baseline, 6-month, or 12-month. Missing data were imputed. A generalized estimating equation (GEE) with a log link function was used with adjustment for covariates.||1.29|0.65|
72483122|NCT01699789|144493085|SUPERIORITY||Mean Difference (Final Values)|1.2|||||TWO_SIDED|95.0|0.2|2.0||||||Intent-to-treat, comparative-effectiveness analyses with intervention status as the independent variable, using a linear regression model adjusted for baseline and covariates, and accounted for the design effect of the cluster randomization. We weighted data for 980 clients to characteristics of the eligible sample, with item-level imputation for missing data and wave-level imputation for missing surveys. Weights account for non-enrollment among eligible clients and attrition.||2.0|0.2|
72511675|NCT06704178|144553720|SUPERIORITY||||||>|0.9999||||||Month 6 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
72511676|NCT06704178|144553721|SUPERIORITY|||||||0.4598||||||Month 1 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.4598
72511677|NCT06704178|144553721|SUPERIORITY|||||||0.23||||||Month 2 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.23
72511678|NCT06704178|144553721|SUPERIORITY|||||||0.0806||||||Month 3 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.0806
72511679|NCT06704178|144553721|SUPERIORITY|||||||0.0969||||||Month 4 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.0969
72511680|NCT06704178|144553721|SUPERIORITY|||||||0.6098||||||Month 5 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.6098
72511681|NCT06704178|144553721|SUPERIORITY|||||||0.0369||||||Month 6 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.0369
72511682|NCT06704178|144553722|SUPERIORITY|||||||0.0384||||||Month 1 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.0384
72511683|NCT06704178|144553722|SUPERIORITY|||||||0.6328||||||Month 2 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.6328
72511684|NCT06704178|144553722|SUPERIORITY|||||||0.0026||||||Month 3 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.0026
72402240|NCT01480076|144311667|SUPERIORITY_OR_OTHER||least squares mean|-7.6|STANDARD_ERROR_OF_MEAN|1.9|<|0.0001|TWO_SIDED||||||mixed effect model|||Month 6, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MSIS-29 physical score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
72402241|NCT01480076|144311667|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 9, Responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MSIS-29 physical score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
72402242|NCT01480076|144311667|SUPERIORITY_OR_OTHER|||||||0.8858|||||||mixed effect model|||Month 9, Non-responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MSIS-29 physical score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.8858
72402243|NCT01480076|144311667|SUPERIORITY_OR_OTHER||least squares mean|-8.6|STANDARD_ERROR_OF_MEAN|2.12|<|0.0001|TWO_SIDED||||||mixed effect model|||Month 9, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MSIS-29 physical score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
72402244|NCT01480076|144311667|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 12, Responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MSIS-29 physical score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
72402245|NCT01480076|144311667|SUPERIORITY_OR_OTHER|||||||0.2111|||||||mixed effect model|||Month 12, Non-responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MSIS-29 physical score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.2111
72402246|NCT01480076|144311667|SUPERIORITY_OR_OTHER||least squares mean|-5.8|STANDARD_ERROR_OF_MEAN|2.16||0.0072|TWO_SIDED||||||mixed effect model|||Month 12, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MSIS-29 physical score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0072
72402247|NCT01480076|144311668|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Overall, Responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MSIS-29 psychological score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
72511685|NCT06704178|144553722|SUPERIORITY|||||||0.0012||||||Month 4 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.0012
72511686|NCT06704178|144553722|SUPERIORITY|||||||0.0118||||||Month 5 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.0118
72511687|NCT06704178|144553722|SUPERIORITY|||||||0.0221||||||Month 6 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.0221
72511688|NCT06704178|144553723|SUPERIORITY||||||>|0.9999||||||Month 1 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
72511689|NCT06704178|144553723|SUPERIORITY||||||>|0.9999||||||Month 2 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
72511690|NCT06704178|144553723|SUPERIORITY||||||>|0.9999||||||Month 3 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
72511691|NCT06704178|144553723|SUPERIORITY||||||>|0.9999||||||Month 4 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
72511692|NCT06704178|144553723|SUPERIORITY||||||>|0.9999||||||Month 5 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
72511693|NCT06704178|144553723|SUPERIORITY||||||>|0.9999||||||Month 6 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
72511694|NCT06704178|144553724|SUPERIORITY||||||>|0.9999||||||Month 1 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
72511695|NCT06704178|144553724|SUPERIORITY||||||>|0.9999||||||Month 2 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
72511696|NCT06704178|144553724|SUPERIORITY||||||>|0.9999||||||Month 3 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
72511697|NCT06704178|144553724|SUPERIORITY||||||>|0.9999||||||Month 4 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
72511698|NCT06704178|144553724|SUPERIORITY||||||>|0.9999||||||Month 5 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
72511699|NCT06704178|144553724|SUPERIORITY||||||>|0.9999||||||Month 6 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
72511700|NCT06704178|144553725|SUPERIORITY||||||>|0.9999||||||Month 1 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
72511701|NCT06704178|144553725|SUPERIORITY||||||>|0.9999||||||Month 2 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
72511702|NCT06704178|144553725|SUPERIORITY||||||>|0.9999||||||Month 3 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
72511703|NCT06704178|144553725|SUPERIORITY||||||>|0.9999||||||Month 4 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
72511704|NCT06704178|144553725|SUPERIORITY||||||>|0.9999||||||Month 5 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
72511705|NCT06704178|144553725|SUPERIORITY||||||>|0.9999||||||Month 6 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
72402248|NCT01480076|144311668|SUPERIORITY_OR_OTHER|||||||0.5577|||||||mixed effect model|||Overall, Non-responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MSIS-29 psychological score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.5577
72402249|NCT01480076|144311668|SUPERIORITY_OR_OTHER||least squares mean|-6.7|STANDARD_ERROR_OF_MEAN|1.64|<|0.0001|TWO_SIDED||||||mixed effect model|||Overall, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MSIS-29 psychological score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
72402250|NCT01480076|144311668|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 3, Responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MSIS-29 psychological score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
72402251|NCT01480076|144311668|SUPERIORITY_OR_OTHER|||||||0.9365|||||||mixed effect model|||Month 3, Non-responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MSIS-29 psychological score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.9365
72402252|NCT01480076|144311668|SUPERIORITY_OR_OTHER||least squares mean|-9.4|STANDARD_ERROR_OF_MEAN|1.82|<|0.0001|TWO_SIDED||||||mixed effect model|||Month 3, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MSIS-29 psychological score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
72402253|NCT01480076|144311668|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 6, Responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MSIS-29 psychological score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
72402254|NCT01480076|144311668|SUPERIORITY_OR_OTHER|||||||0.2008|||||||mixed effect model|||Month 6, Non-responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MSIS-29 psychological score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.2008
72483123|NCT01699789|144493086|SUPERIORITY||Rate Ratio (RR)|0.2|||||TWO_SIDED|95.0|0.1|0.8||||||Intent-to-treat, comparative-effectiveness analyses with intervention status as the independent variable, using a Poisson regression model adjusted for baseline and covariates, and accounted for the design effect of the cluster randomization. We weighted data for 980 clients to characteristics of the eligible sample, with item-level imputation for missing data and wave-level imputation for missing surveys. Weights account for non-enrollment among eligible clients and attrition.||0.8|0.1|
72483124|NCT01699789|144493087|SUPERIORITY||Rate Ratio (RR)|1.2|||||TWO_SIDED|95.0|0.4|3.7||||||Intent-to-treat, comparative-effectiveness analyses with intervention status as the independent variable, using a Poisson regression model adjusted for baseline and covariates, and accounted for the design effect of the cluster randomization. We weighted data for 980 clients to characteristics of the eligible sample, with item-level imputation for missing data and wave-level imputation for missing surveys. Weights account for non-enrollment among eligible clients and attrition.||3.7|0.4|
72483125|NCT01699789|144493088|SUPERIORITY||Rate Ratio (RR)|1.1|||||TWO_SIDED|95.0|0.8|1.5||||||Intent-to-treat, comparative-effectiveness analyses with intervention status as the independent variable, using a Poisson regression model adjusted for baseline and covariates, and accounted for the design effect of the cluster randomization. We weighted data for 980 clients to characteristics of the eligible sample, with item-level imputation for missing data and wave-level imputation for missing surveys. Weights account for non-enrollment among eligible clients and attrition.||1.5|0.8|
72483126|NCT01699789|144493089|SUPERIORITY||Rate Ratio (RR)|1.0|||||TWO_SIDED|95.0|0.5|2.1||||||Intent-to-treat, comparative-effectiveness analyses with intervention status as the independent variable, using a Poisson regression model adjusted for baseline and covariates, and accounted for the design effect of the cluster randomization. We weighted data for 980 clients to characteristics of the eligible sample, with item-level imputation for missing data and wave-level imputation for missing surveys. Weights account for non-enrollment among eligible clients and attrition.||2.1|0.5|
72511706|NCT06704178|144553726|SUPERIORITY||||||>|0.9999||||||Month 1 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
72511707|NCT06704178|144553726|SUPERIORITY||||||>|0.9999||||||Month 2 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
72511708|NCT06704178|144553726|SUPERIORITY||||||>|0.9999||||||Month 3 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
72511709|NCT06704178|144553726|SUPERIORITY||||||>|0.9999||||||Month 4 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
72402255|NCT01480076|144311668|SUPERIORITY_OR_OTHER||least squares mean|-5.1|STANDARD_ERROR_OF_MEAN|1.98||0.0102|TWO_SIDED||||||mixed effect model|||Month 6, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MSIS-29 psychological score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0102
72511710|NCT06704178|144553726|SUPERIORITY||||||>|0.9999||||||Month 5 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
72511711|NCT06704178|144553726|SUPERIORITY||||||>|0.9999||||||Month 6 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
72511712|NCT06704178|144553727|SUPERIORITY||||||>|0.9999||||||Month 1 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
72511713|NCT06704178|144553727|SUPERIORITY||||||>|0.9999||||||Month 2 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
72483127|NCT01699789|144493090|SUPERIORITY||Rate Ratio (RR)|1.0|||||TWO_SIDED|95.0|0.7|1.6||||||Intent-to-treat, comparative-effectiveness analyses with intervention status as the independent variable, using a Poisson regression model adjusted for baseline and covariates, and accounted for the design effect of the cluster randomization. We weighted data for 980 clients to characteristics of the eligible sample, with item-level imputation for missing data and wave-level imputation for missing surveys. Weights account for non-enrollment among eligible clients and attrition.||1.6|0.7|
72483128|NCT01699789|144493091|SUPERIORITY||Rate Ratio (RR)|1.1|||||TWO_SIDED|95.0|0.3|4.0||||||Intent-to-treat, comparative-effectiveness analyses with intervention status as the independent variable, using a Poisson regression model adjusted for baseline and covariates, and accounted for the design effect of the cluster randomization. We weighted data for 980 clients to characteristics of the eligible sample, with item-level imputation for missing data and wave-level imputation for missing surveys. Weights account for non-enrollment among eligible clients and attrition.||4.0|0.3|
72483129|NCT01699789|144493092|SUPERIORITY||Rate Ratio (RR)|1.1|||||TWO_SIDED|95.0|0.4|2.7||||||Intent-to-treat, comparative-effectiveness analyses with intervention status as the independent variable, using a Poisson regression model adjusted for baseline and covariates, and accounted for the design effect of the cluster randomization. We weighted data for 980 clients to characteristics of the eligible sample, with item-level imputation for missing data and wave-level imputation for missing surveys. Weights account for non-enrollment among eligible clients and attrition.||2.7|0.4|
72483130|NCT01699789|144493093|SUPERIORITY||Rate Ratio (RR)|1.4|||||TWO_SIDED|95.0|0.2|8.6||||||Intent-to-treat, comparative-effectiveness analyses with intervention status as the independent variable, using a Poisson regression model adjusted for baseline and covariates, and accounted for the design effect of the cluster randomization. We weighted data for 980 clients to characteristics of the eligible sample, with item-level imputation for missing data and wave-level imputation for missing surveys. Weights account for non-enrollment among eligible clients and attrition.||8.6|0.2|
72511714|NCT06704178|144553727|SUPERIORITY||||||>|0.9999||||||Month 3 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
72511715|NCT06704178|144553727|SUPERIORITY||||||>|0.9999||||||Month 4 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
72511716|NCT06704178|144553727|SUPERIORITY||||||>|0.9999||||||Month 5 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
72511717|NCT06704178|144553727|SUPERIORITY||||||>|0.9999||||||Month 6 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
72511718|NCT06704178|144553728|SUPERIORITY||||||>|0.9999||||||Month 1 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
72511719|NCT06704178|144553728|SUPERIORITY||||||>|0.9999||||||Month 2 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
72511720|NCT06704178|144553728|SUPERIORITY||||||>|0.9999||||||Month 3 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
72511721|NCT06704178|144553728|SUPERIORITY||||||>|0.9999||||||Month 4 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
72511722|NCT06704178|144553728|SUPERIORITY||||||>|0.9999||||||Month 5 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
72511723|NCT06704178|144553728|SUPERIORITY||||||>|0.9999||||||Month 6 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
72511724|NCT06704178|144553729|SUPERIORITY||||||>|0.9999||||||Month 1 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
72511725|NCT06704178|144553729|SUPERIORITY||||||>|0.9999||||||Month 2 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
72511726|NCT06704178|144553729|SUPERIORITY||||||>|0.9999||||||Month 3 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
72511727|NCT06704178|144553729|SUPERIORITY||||||>|0.9999||||||Month 4 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
72567214|NCT03265288|144665361|SUPERIORITY||Risk Ratio (RR)|1.55||||0.3366|TWO_SIDED|95.0|0.63|3.8||alpha is set to 0.05|Regression, Cox||Odds ratio \< 1 means lower odds of a pulmonary exacerbation with LAU-7b, odds ratio close to 1 means similar odds of a pulmonary exacerbation for LAU-7b and placebo, odds ratio \> 1 means higher odds of a pulmonary exacerbation with LAU-7b|Protocol-Defined IV antibiotics-treated pulmonary exacerbation events. Intent to treat population (ITT), null hypothesis is no treatment effect||3.80|0.63|0.3366
72511728|NCT06704178|144553729|SUPERIORITY||||||>|0.9999||||||Month 5 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
72511729|NCT06704178|144553729|SUPERIORITY||||||>|0.9999||||||Month 6 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
72511730|NCT06704178|144553730|SUPERIORITY||||||>|0.9999||||||Month 1 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
72511731|NCT06704178|144553730|SUPERIORITY||||||>|0.9999||||||Month 2 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
72511732|NCT06704178|144553730|SUPERIORITY||||||>|0.9999||||||Month 3 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
72511733|NCT06704178|144553730|SUPERIORITY||||||>|0.9999||||||Month 4 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
72511734|NCT06704178|144553730|SUPERIORITY||||||>|0.9999||||||Month 5 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
72567215|NCT03265288|144665361|OTHER||Risk Ratio (RR)|1.34||||0.3936|TWO_SIDED|95.0|0.68|2.64||alpha is set to 0.05|Regression, Cox||Odds ratio \< 1 means lower odds of a pulmonary exacerbation with LAU-7b, odds ratio close to 1 means similar odds of a pulmonary exacerbation for LAU-7b and placebo, odds ratio \> 1 means higher odds of a pulmonary exacerbation with LAU-7b|ALL IV antibiotics-treated pulmonary exacerbation events. Intent to treat population (ITT), null hypothesis is no treatment effect||2.64|0.68|0.3936
72511735|NCT06704178|144553730|SUPERIORITY||||||>|0.9999||||||Month 6 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
72511736|NCT06704178|144553731|SUPERIORITY||||||>|0.9999||||||Month 1 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
72511737|NCT06704178|144553731|SUPERIORITY||||||>|0.9999||||||Month 2 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
72511738|NCT06704178|144553731|SUPERIORITY|||||||0.3682||||||Month 3 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.3682
72511739|NCT06704178|144553731|SUPERIORITY|||||||0.6098||||||Month 4 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.6098
72511740|NCT06704178|144553731|SUPERIORITY||||||>|0.9999||||||Month 5 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
72402256|NCT01480076|144311668|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 9, Responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MSIS-29 psychological score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
72483131|NCT01699789|144493094|SUPERIORITY||Rate Ratio (RR)|0.9|||||TWO_SIDED|95.0|0.4|1.8||||||Intent-to-treat, comparative-effectiveness analyses with intervention status as the independent variable, using a Poisson regression model adjusted for baseline and covariates, and accounted for the design effect of the cluster randomization. We weighted data for 980 clients to characteristics of the eligible sample, with item-level imputation for missing data and wave-level imputation for missing surveys. Weights account for non-enrollment among eligible clients and attrition.||1.8|0.4|
72483132|NCT01699789|144493095|SUPERIORITY||Odds Ratio (OR)|1.8|||||TWO_SIDED|95.0|1.2|2.6||||||Intent-to-treat, comparative-effectiveness analyses with intervention status as the independent variable, using a logistic regression model adjusted for baseline and covariates, and accounted for the design effect of the cluster randomization. We weighted data for 980 clients to characteristics of the eligible sample, with item-level imputation for missing data and wave-level imputation for missing surveys. Weights account for non-enrollment among eligible clients and attrition.||2.6|1.2|
72483133|NCT01699789|144493096|SUPERIORITY||Odds Ratio (OR)|0.9|||||TWO_SIDED|95.0|0.5|1.5||||||Intent-to-treat, comparative-effectiveness analyses with intervention status as the independent variable, using a logistic regression model adjusted for baseline and covariates, and accounted for the design effect of the cluster randomization. We weighted data for 980 clients to characteristics of the eligible sample, with item-level imputation for missing data and wave-level imputation for missing surveys. Weights account for non-enrollment among eligible clients and attrition.||1.5|0.5|
72483134|NCT01699789|144493097|SUPERIORITY||Odds Ratio (OR)|2.9|||||TWO_SIDED|95.0|1.0|8.3||||||Intent-to-treat, comparative-effectiveness analyses with intervention status as the independent variable, using a logistic regression model adjusted for baseline and covariates, and accounted for the design effect of the cluster randomization. We weighted data for 980 clients to characteristics of the eligible sample, with item-level imputation for missing data and wave-level imputation for missing surveys. Weights account for non-enrollment among eligible clients and attrition.||8.3|1.0|
72483135|NCT01699789|144493098|SUPERIORITY||Odds Ratio (OR)|1.1|||||TWO_SIDED|95.0|0.7|1.7||||||Intent-to-treat, comparative-effectiveness analyses with intervention status as the independent variable, using a logistic regression model adjusted for baseline and covariates, and accounted for the design effect of the cluster randomization. We weighted data for 980 clients to characteristics of the eligible sample, with item-level imputation for missing data and wave-level imputation for missing surveys. Weights account for non-enrollment among eligible clients and attrition.||1.7|0.7|
72483136|NCT01699789|144493099|SUPERIORITY||Odds Ratio (OR)|1.0|||||TWO_SIDED|95.0|0.5|2.0||||||Intent-to-treat, comparative-effectiveness analyses with intervention status as the independent variable, using a logistic regression model adjusted for baseline and covariates, and accounted for the design effect of the cluster randomization. We weighted data for 980 clients to characteristics of the eligible sample, with item-level imputation for missing data and wave-level imputation for missing surveys. Weights account for non-enrollment among eligible clients and attrition.||2.0|0.5|
72511741|NCT06704178|144553731|SUPERIORITY||||||>|0.9999||||||Month 6 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
72511742|NCT06704178|144553732|SUPERIORITY||||||>|0.9999||||||Month 1 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
72511743|NCT06704178|144553732|SUPERIORITY|||||||0.5691||||||Month 2 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.5691
72483137|NCT01699789|144493100|SUPERIORITY||Odds Ratio (OR)|1.4|||||TWO_SIDED|95.0|1.0|2.0||||||Intent-to-treat, comparative-effectiveness analyses with intervention status as the independent variable, using a logistic regression model adjusted for baseline and covariates, and accounted for the design effect of the cluster randomization. We weighted data for 980 clients to characteristics of the eligible sample, with item-level imputation for missing data and wave-level imputation for missing surveys. Weights account for non-enrollment among eligible clients and attrition.||2.0|1.0|
72483138|NCT01699789|144493101|SUPERIORITY||Odds Ratio (OR)|1.0|||||TWO_SIDED|95.0|0.6|1.7||||||Intent-to-treat, comparative-effectiveness analyses with intervention status as the independent variable, using a logistic regression model adjusted for baseline and covariates, and accounted for the design effect of the cluster randomization. We weighted data for 980 clients to characteristics of the eligible sample, with item-level imputation for missing data and wave-level imputation for missing surveys. Weights account for non-enrollment among eligible clients and attrition.||1.7|0.6|
72483139|NCT01699789|144493102|SUPERIORITY||Cox Proportional Hazard|1.12|||>|0.05|TWO_SIDED|95.0|0.83|1.5|||Regression, Cox|||Intent-to-treat, comparative-effectiveness analyses with intervention status as the independent variable, using a Cox proportional-hazards model adjusted for baseline covariates. Data were multiply imputed and weighted for eligible sample for enrollment, accounted for the design effect of the cluster randomization.||1.50|0.83|>.05
72483140|NCT01699789|144493103|SUPERIORITY||Cox Proportional Hazard|1.23|||>|0.05|TWO_SIDED|95.0|0.99|1.52|||Regression, Cox|||Intent-to-treat, comparative-effectiveness analyses with intervention status as the independent variable, using a Cox proportional-hazards model adjusted for baseline covariates. Data were multiply imputed and weighted for eligible sample for enrollment, accounted for the design effect of the cluster randomization.||1.52|0.99|>0.05
72483141|NCT01699789|144493104|SUPERIORITY||Odds Ratio (OR)|1.73|||||TWO_SIDED|95.0|1.0|2.99||||||Intent-to-treat, comparative-effectiveness analyses with intervention status as the independent variable, using a logistic regression model adjusted for baseline covariates. Data were multiply imputed and weighted for eligible sample for enrollment, accounted for the design effect of the cluster randomization.||2.99|1.00|
72511744|NCT06704178|144553732|SUPERIORITY||||||>|0.9999||||||Month 3 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
72511745|NCT06704178|144553732|SUPERIORITY||||||>|0.9999||||||Month 4 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
72511746|NCT06704178|144553732|SUPERIORITY|||||||0.6983||||||Month 5 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.6983
72483142|NCT01699789|144493105|SUPERIORITY||Odds Ratio (OR)|2.62|||||TWO_SIDED|95.0|1.24|5.54||||||Intent-to-treat, comparative-effectiveness analyses with intervention status as the independent variable, using a logistic regression model adjusted for baseline covariates. Data were multiply imputed and weighted for eligible sample for enrollment, accounted for the design effect of the cluster randomization.||5.54|1.24|
72483143|NCT02460666|144493112|SUPERIORITY|||||||0.3|||||||Mixed Models Analysis|||||||0.3
72483144|NCT02460666|144493113|SUPERIORITY|||||||0.2|||||||Mixed Models Analysis|||||||0.2
72483145|NCT02460666|144493114|SUPERIORITY|||||||0.5|||||||Mixed Models Analysis|||||||0.5
72483146|NCT02460666|144493115|SUPERIORITY|||||||0.09|||||||Mixed Models Analysis|||||||0.09
72483147|NCT01323621|144493117|SUPERIORITY_OR_OTHER||Least squares mean difference|0.029||||0.267||95.0|-0.022|0.08|||ANCOVA||ANCOVA analysis was conducted with covariates for country, smoking status, reversibility, and Baseline FEV1.|||0.080|-0.022|0.267
72483148|NCT01557348|144493119|SUPERIORITY_OR_OTHER|||||||0.0068||||||LsMean and p-value are based on an ANCOVA model adjusted for significant factors leading to selection of new biologic therapy and unbalanced baseline covariates.|ANCOVA|||||||0.0068
72483149|NCT01557348|144493120|SUPERIORITY_OR_OTHER|||||||0.0588||||||LsMean and p-value are based on an ANCOVA model adjusted for significant factors leading to selection of new biologic therapy and unbalanced baseline covariates.|ANCOVA|||||||0.0588
72483150|NCT01557348|144493121|SUPERIORITY_OR_OTHER|||||||0.1126||||||LsMean and p-value are based on an ANCOVA model adjusted for significant factors leading to selection of new biologic therapy and unbalanced baseline covariates.|ANCOVA|||Comparison of least squares mean change from Baseline in TJC at Month 6||||0.1126
72483151|NCT01557348|144493121|SUPERIORITY_OR_OTHER|||||||0.2342||||||LsMean and p-value are based on an ANCOVA model adjusted for significant factors leading to selection of new biologic therapy and unbalanced baseline covariates.|ANCOVA|||Comparison of least squares mean change from Baseline in TJC at Month 12||||0.2342
72483152|NCT01557348|144493122|SUPERIORITY_OR_OTHER|||||||0.4168||||||LsMean and p-value are based on an ANCOVA model adjusted for significant factors leading to selection of new biologic therapy and unbalanced baseline covariates.|ANCOVA|||Comparison of least squares mean change from Baseline in SJC at Month 6||||0.4168
72483153|NCT01557348|144493122|SUPERIORITY_OR_OTHER|||||||0.5867||||||LsMean and p-value are based on an ANCOVA model adjusted for significant factors leading to selection of new biologic therapy and unbalanced baseline covariates.|ANCOVA|||Comparison of least squares mean change from Baseline in SJC at Month 12||||0.5867
72483154|NCT01557348|144493123|SUPERIORITY_OR_OTHER|||||||0.8758||||||LsMean and p-value are based on an ANCOVA model adjusted for significant factors leading to selection of new biologic therapy and unbalanced baseline covariates.|ANCOVA|||Comparison of least squares mean change from Baseline in CRP at Month 6||||0.8758
72483155|NCT01557348|144493123|SUPERIORITY_OR_OTHER|||||||0.4849||||||LsMean and p-value are based on an ANCOVA model adjusted for significant factors leading to selection of new biologic therapy and unbalanced baseline covariates.|ANCOVA|||Comparison of least squares mean change from Baseline in CRP at Month 12||||0.4849
72483156|NCT01557348|144493124|SUPERIORITY_OR_OTHER|||||||0.0086||||||LsMean and p-value are based on an ANCOVA model adjusted for significant factors leading to selection of new biologic therapy and unbalanced baseline covariates.|ANCOVA|||Comparison of least squares mean change from Baseline in ESR at Month 6||||0.0086
72483157|NCT01557348|144493124|SUPERIORITY_OR_OTHER|||||||0.2918||||||LsMean and p-value are based on an ANCOVA model adjusted for significant factors leading to selection of new biologic therapy and unbalanced baseline covariates.|ANCOVA|||Comparison of least squares mean change from Baseline in ESR at Month 12||||0.2918
72483158|NCT01557348|144493125|SUPERIORITY_OR_OTHER|||||||0.0764||||||LsMean and p-value are based on an ANCOVA model adjusted for significant factors leading to selection of new biologic therapy and unbalanced baseline covariates.|ANCOVA|||Comparison of least squares mean change from Baseline in Physician Global Assessment of Disease at Month 6||||0.0764
72483159|NCT01557348|144493125|SUPERIORITY_OR_OTHER|||||||0.0587||||||LsMean and p-value are based on an ANCOVA model adjusted for significant factors leading to selection of new biologic therapy and unbalanced baseline covariates.|ANCOVA|||Comparison of least squares mean change from Baseline in Physician Global Assessment of Disease at Month 12||||0.0587
72483160|NCT01557348|144493126|SUPERIORITY_OR_OTHER|||||||0.0443||||||LsMean and p-value are based on an ANCOVA model adjusted for significant factors leading to selection of new biologic therapy and unbalanced baseline covariates.|ANCOVA|||Comparison of least squares mean change from Baseline in Patient Global Assessment of Disease at Month 6||||0.0443
72483161|NCT01557348|144493126|SUPERIORITY_OR_OTHER|||||||0.4802||||||LsMean and p-value are based on an ANCOVA model adjusted for significant factors leading to selection of new biologic therapy and unbalanced baseline covariates.|ANCOVA|||Comparison of least squares mean change from Baseline in Patient Global Assessment of Disease at Month 12||||0.4802
72483162|NCT01557348|144493127|SUPERIORITY_OR_OTHER|||||||0.2026||||||LsMean and p-value are based on an ANCOVA model adjusted for significant factors leading to selection of new biologic therapy and unbalanced baseline covariates.|ANCOVA|||Comparison of least squares mean change from Baseline in Participant's Visual Analogue Scale Pain Score at Months 6||||0.2026
72483163|NCT01557348|144493127|SUPERIORITY_OR_OTHER|||||||0.0295||||||LsMean and p-value are based on an ANCOVA model adjusted for significant factors leading to selection of new biologic therapy and unbalanced baseline covariates.|ANCOVA|||Comparison of least squares mean change from Baseline in Participant's Visual Analogue Scale Pain Score at Months 12||||0.0295
72511747|NCT06704178|144553732|SUPERIORITY||||||>|0.9999||||||Month 6 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
72511748|NCT06704178|144553733|SUPERIORITY|||||||0.819||||||Month 1 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.819
72511749|NCT06704178|144553733|SUPERIORITY||||||>|0.9999||||||Month 2 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
72511750|NCT06704178|144553733|SUPERIORITY|||||||0.5749||||||Month 3 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.5749
72511751|NCT06704178|144553733|SUPERIORITY|||||||0.4873||||||Month 4 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.4873
72511752|NCT06704178|144553733|SUPERIORITY|||||||0.9998||||||Month 5 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.9998
72511753|NCT06704178|144553733|SUPERIORITY|||||||0.819||||||Month 6 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.819
72511754|NCT06704178|144553734|SUPERIORITY||||||>|0.9999||||||Month 1 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
72483164|NCT01557348|144493128|SUPERIORITY_OR_OTHER|||||||0.337||||||LsMean and p-value are based on an ANCOVA model adjusted for significant factors leading to selection of new biologic therapy and unbalanced baseline covariates.|ANCOVA|||Comparison of least squares mean change from Baseline in HAQ-DI at Month 6||||0.3370
72483165|NCT01557348|144493128|SUPERIORITY_OR_OTHER|||||||0.1515||||||LsMean and p-value are based on an ANCOVA model adjusted for significant factors leading to selection of new biologic therapy and unbalanced baseline covariates.|ANCOVA|||Comparison of least squares mean change from Baseline in HAQ-DI at Month 12||||0.1515
72483166|NCT01557348|144493129|SUPERIORITY_OR_OTHER|||||||0.3253||||||LsMean and p-value are based on an ANCOVA model adjusted for significant factors leading to selection of new biologic therapy and unbalanced baseline covariates.|ANCOVA|||Comparison of least squares mean change from Baseline in duration of morning stiffness at month 6||||0.3253
72483167|NCT01557348|144493129|SUPERIORITY_OR_OTHER|||||||0.3535||||||LsMean and p-value are based on an ANCOVA model adjusted for significant factors leading to selection of new biologic therapy and unbalanced baseline covariates.|ANCOVA|||Comparison of least squares mean change from Baseline in duration of morning stiffness at month 12||||0.3535
72483168|NCT02708095|144493140|SUPERIORITY||Odds Ratio (OR)|1.28||||0.392|TWO_SIDED|95.0|0.73|2.27|||Regression, Logistic|||||2.27|0.73|0.392
72483169|NCT02708095|144493140|SUPERIORITY||Odds Ratio (OR)|1.84||||0.041|TWO_SIDED|95.0|1.02|3.29|||Regression, Logistic|||||3.29|1.02|0.041
72483170|NCT02708095|144493141|SUPERIORITY||Odds Ratio, log|1.25||||0.44|TWO_SIDED|95.0|0.71|2.19|||Regression, Logistic|||||2.19|0.71|0.440
72483171|NCT02708095|144493141|SUPERIORITY||Odds Ratio (OR)|2.04||||0.015|TWO_SIDED|95.0|1.15|3.62|||Regression, Logistic|||||3.62|1.15|0.015
72483172|NCT02708095|144493142|SUPERIORITY||LS Mean Difference (Final Vaules)|-0.26||||0.6|TWO_SIDED|95.0|-1.23|0.71|||Mixed Models Analysis|||||0.71|-1.23|0.600
72483173|NCT02708095|144493142|SUPERIORITY||LS Mean Difference (Final Vaules)|-0.58||||0.243|TWO_SIDED|95.0|-1.55|0.39|||Mixed Models Analysis|||||0.39|-1.55|0.243
72511755|NCT06704178|144553734|SUPERIORITY||||||>|0.9999||||||Month 2 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
72511756|NCT06704178|144553734|SUPERIORITY|||||||0.8495||||||Month 3 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.8495
72511757|NCT06704178|144553734|SUPERIORITY||||||>|0.9999||||||Month 4 versus Baseline.|t-test, 2 sided|Within-group analysis.||||||>0.9999
72511758|NCT06704178|144553734|SUPERIORITY|||||||0.1951||||||Month 5 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.1951
72483174|NCT02708095|144493143|SUPERIORITY||LS Mean Difference (Final Vaules)|-0.16||||0.285|TWO_SIDED|95.0|-0.45|0.13|||Mixed Models Analysis|||||0.13|-0.45|0.285
72483175|NCT02708095|144493143|SUPERIORITY||LS Mean Difference (Final Vaules)|-0.33||||0.026|TWO_SIDED|95.0|-0.62|-0.04|||Mixed Models Analysis|||||-0.04|-0.62|0.026
72511759|NCT06704178|144553734|SUPERIORITY|||||||0.0806||||||Month 6 versus Baseline.|t-test, 2 sided|Within-group analysis.||||||0.0806
72511760|NCT06704178|144553735|SUPERIORITY||||||>|0.9999||||||Month 1 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
72511761|NCT06704178|144553735|SUPERIORITY|||||||0.6983||||||Month 2 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.6983
72511762|NCT06704178|144553735|SUPERIORITY|||||||0.1062||||||Month 3 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.1062
72511763|NCT06704178|144553735|SUPERIORITY|||||||0.0333||||||Month 4 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.0333
72483176|NCT01313650|144493149|SUPERIORITY_OR_OTHER||Least squares mean difference|0.115|||<|0.001|TWO_SIDED|95.0|0.076|0.155|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least squares mean difference=UMEC 62.5 µg minus Placebo.|||0.155|0.076|<0.001
72483177|NCT01313650|144493149|SUPERIORITY_OR_OTHER||Least squares mean difference|0.072|||<|0.001|TWO_SIDED|95.0|0.032|0.112|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least squares mean difference=VI 25 µg minus Placebo.|||0.112|0.032|<0.001
72511764|NCT06704178|144553735|SUPERIORITY|||||||0.0734||||||Month 5 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.0734
72511765|NCT06704178|144553735|SUPERIORITY|||||||0.0219||||||Month 6 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.0219
72483178|NCT01313650|144493149|SUPERIORITY_OR_OTHER||Least squares mean difference|0.167|||<|0.001|TWO_SIDED|95.0|0.128|0.207|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least squares mean difference=UMEC/VI 62.5/25 µg minus Placebo.|||0.207|0.128|<0.001
72483179|NCT01313650|144493149|SUPERIORITY_OR_OTHER||Least squares mean difference|0.052||||0.004|TWO_SIDED|95.0|0.017|0.087|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least squares mean difference=UMEC/VI 62.5/25 minus UMEC 62.5 µg.|||0.087|0.017|0.004
72483180|NCT01313650|144493149|SUPERIORITY_OR_OTHER||Least squares mean difference|0.095|||<|0.001|TWO_SIDED|95.0|0.06|0.13|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least squares mean difference=UMEC/VI 62.5/25 minus VI 25 µg.|||0.130|0.060|<0.001
72483181|NCT00458341|144493165|OTHER|||||||0.133||||||Threshold for significance at 0.05 level.|t-test, 2 sided|||Baseline of Cycle 1 versus Day 14 of Cycle 1||||0.133
72511766|NCT06704178|144553736|SUPERIORITY||||||>|0.9999||||||Month 1 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
72511767|NCT06704178|144553736|SUPERIORITY||||||>|0.9999||||||Month 2 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
72511768|NCT06704178|144553736|SUPERIORITY||||||>|0.9999||||||Month 3 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
72511769|NCT06704178|144553736|SUPERIORITY||||||>|0.9999||||||Month 4 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
72511770|NCT06704178|144553736|SUPERIORITY||||||>|0.9999||||||Month 5 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
72511771|NCT06704178|144553736|SUPERIORITY||||||>|0.9999||||||Month 6 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
72402257|NCT01480076|144311668|SUPERIORITY_OR_OTHER|||||||0.7134|||||||mixed effect model|||Month 9, Non-responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MSIS-29 psychological score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.7134
72402258|NCT01480076|144311668|SUPERIORITY_OR_OTHER||least squares mean|-6.0|STANDARD_ERROR_OF_MEAN|2.2||0.0066|TWO_SIDED||||||mixed effect model|||Month 9, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MSIS-29 psychological score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0066
72511772|NCT06704178|144553737|SUPERIORITY||||||>|0.9999||||||Month 1 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
72511773|NCT06704178|144553737|SUPERIORITY||||||>|0.9999||||||Month 2 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
72511774|NCT06704178|144553737|SUPERIORITY||||||>|0.9999||||||Month 3 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
72511775|NCT06704178|144553737|SUPERIORITY||||||>|0.9999||||||Month 4 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
72511776|NCT06704178|144553737|SUPERIORITY||||||>|0.9999||||||Month 5 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
72511777|NCT06704178|144553737|SUPERIORITY||||||>|0.9999||||||Month 6 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
72511778|NCT06704178|144553738|SUPERIORITY||||||>|0.9999||||||Month 1 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
72511779|NCT06704178|144553738|SUPERIORITY|||||||0.982||||||Month 2 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.982
72511780|NCT06704178|144553738|SUPERIORITY|||||||0.091||||||Month 3 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.091
72511781|NCT06704178|144553738|SUPERIORITY|||||||0.4449||||||Month 4 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.4449
72511782|NCT06704178|144553738|SUPERIORITY|||||||0.0204||||||Month 5 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.0204
72511783|NCT06704178|144553738|SUPERIORITY|||||||0.0256||||||Month 6 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.0256
72511784|NCT06704178|144553739|SUPERIORITY|||||||0.9821||||||Month 1 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.9821
72511785|NCT06704178|144553739|SUPERIORITY|||||||0.0403||||||Month 2 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.0403
72511786|NCT06704178|144553739|SUPERIORITY|||||||0.0638||||||Month 3 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.0638
72511787|NCT06704178|144553739|SUPERIORITY|||||||0.7195||||||Month 4 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.7195
72483182|NCT00458341|144493165|OTHER|||||||0.19||||||Threshold for significance at 0.05 level.|t-test, 2 sided|||Baseline of Cycle 1 versus Day 14 of Cycle 1||||0.190
72483183|NCT00458341|144493165|OTHER|||||||0.123||||||Threshold for significance at 0.05 level.|t-test, 2 sided|||Baseline of Cycle 2 versus Day 14 of Cycle 2||||0.123
72483184|NCT00458341|144493165|OTHER|||||||0.592||||||Threshold for significance at 0.05 level.|t-test, 2 sided|||Baseline of Cycle 2 versus Day 14 of Cycle 2||||0.592
72483185|NCT00458341|144493166|OTHER|||||||0.021|||||||Chi-squared|||Analysis of Cycle 1 data. Analysis was to compare the observed rate with the null hypothesis response rate of 10%.||||0.021
72483186|NCT00458341|144493166|OTHER|||||||0.021|||||||Chi-squared|||Analysis of Cycle 1 data. Analysis was to compare the observed rate with the null hypothesis response rate of 10%.||||0.021
72483187|NCT00458341|144493166|OTHER|||||||0.021|||||||Chi-squared|||Analysis of Cycle 2 data. Analysis was to compare the observed rate with the null hypothesis response rate of 10%.||||0.021
72483188|NCT00458341|144493166|OTHER|||||||0.518|||||||Chi-squared|||Analysis of Cycle 2 data. Analysis was to compare the observed rate with the null hypothesis response rate of 10%.||||0.518
72483189|NCT03471871|144493182|OTHER||Least squares (LS) mean difference|-0.36||||0.099|TWO_SIDED|95.0|-0.78|0.07||P-Value was at the 0.05 level of significance.|Mixed effect model|SPO2 was analyzed by mixed effect model, which included fixed effects for sequence, period, treatment a random effect for participant within sequence.||||0.07|-0.78|0.099
72483190|NCT03471871|144493182|OTHER||LS mean difference|-0.29||||0.176|TWO_SIDED|95.0|-0.72|0.14||P-Value was at the 0.05 level of significance.|Mixed effect model|SPO2 was analyzed by mixed effect model, which included fixed effects for sequence, period, treatment a random effect for participant within sequence.||||0.14|-0.72|0.176
72483191|NCT03471871|144493183|OTHER||LS mean difference|-0.06||||0.948|TWO_SIDED|95.0|-1.95|1.83||P-Value was at the 0.05 level of significance.|Mixed effect model|AHI was analyzed by mixed effect model, which included fixed effects for sequence, period, treatment a random effect for participant within sequence.||||1.83|-1.95|0.948
72511788|NCT06704178|144553739|SUPERIORITY|||||||0.1856||||||Month 5 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.1856
72511789|NCT06704178|144553739|SUPERIORITY|||||||0.1222||||||Month 6 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.1222
72483192|NCT03471871|144493184|OTHER||LS mean difference|0.52||||0.639|TWO_SIDED|95.0|-1.72|2.76||P-Value was at the 0.05 level of significance.|Mixed effect model|AHI was analyzed by mixed effect model, which included fixed effects for sequence, period, treatment a random effect for participant within sequence.||||2.76|-1.72|0.639
72483193|NCT03471871|144493184|OTHER||LS mean difference|-1.16||||0.297|TWO_SIDED|95.0|-3.4|1.08||P-Value was at the 0.05 level of significance.|mixed effect model|AHI was analyzed by mixed effect model, which included fixed effects for sequence, period, treatment a random effect for participant within sequence.||||1.08|-3.40|0.297
72483194|NCT03471871|144493185|OTHER||LS mean difference|-0.03||||0.979|TWO_SIDED|95.0|-2.22|2.17||P-Value was at the 0.05 level of significance.|Mixed effect model|AHI was analyzed by mixed effect model, which included fixed effects for sequence, period, treatment a random effect for participant within sequence.||||2.17|-2.22|0.979
72483195|NCT03471871|144493186|OTHER||LS mean difference|0.185||||0.095|TWO_SIDED|95.0|-0.034|0.405||P-Value was at the 0.05 level of significance.|Mixed effect model|SPO2 was analyzed by mixed effect model, which included fixed effects for sequence, period, treatment a random effect for participant within sequence.||SpO2 is \<90%||0.405|-0.034|0.095
72567216|NCT03265288|144665361|SUPERIORITY||Risk Ratio (RR)|1.16||||0.5011|TWO_SIDED|95.0|0.75|1.79||alpha is set to 0.05|Regression, Cox||Odds ratio \< 1 means lower odds of a pulmonary exacerbation with LAU-7b, odds ratio close to 1 means similar odds of a pulmonary exacerbation for LAU-7b and placebo, odds ratio \> 1 means higher odds of a pulmonary exacerbation with LAU-7b|Combined IV- or Oral antibiotics-treated pulmonary exacerbation events. Intent to treat population (ITT), null hypothesis is no treatment effect||1.79|0.75|0.5011
72483196|NCT03471871|144493186|OTHER||LS mean difference|0.245||||0.03|TWO_SIDED|95.0|0.025|0.464||P-Value was at the 0.05 level of significance.|Mixed effect model|SPO2 was analyzed by mixed effect model, which included fixed effects for sequence, period, treatment a random effect for participant within sequence.||When SpO2 is \<90%||0.464|0.025|0.030
72483197|NCT03471871|144493186|OTHER||LS mean difference|0.004||||0.885|TWO_SIDED|95.0|-0.058|0.067||P-Value was at the 0.05 level of significance.|Mixed effect model|SPO2 was analyzed by mixed effect model, which included fixed effects for sequence, period, treatment a random effect for participant within sequence.||SpO2 is \<85%||0.067|-0.058|0.885
72483198|NCT03471871|144493186|OTHER||LS mean difference|0.044||||0.158|TWO_SIDED|95.0|-0.018|0.107||P-Value was at the 0.05 level of significance.|Mixed effect model|SPO2 was analyzed by mixed effect model, which included fixed effects for sequence, period, treatment a random effect for participant within sequence.||SpO2 is \<85%||0.107|-0.018|0.158
72483199|NCT03471871|144493186|OTHER||LS mean difference|0.001||||0.462|TWO_SIDED|95.0|-0.002|0.005||P-Value was at the 0.05 level of significance.|Mixed effect model|SPO2 was analyzed by mixed effect model, which included fixed effects for sequence, period, treatment a random effect for participant within sequence.||SpO2 is \<80%||0.005|-0.002|0.462
72511790|NCT06704178|144553740|SUPERIORITY||||||>|0.9999||||||Month 1 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
72511791|NCT06704178|144553740|SUPERIORITY||||||>|0.9999||||||Month 2 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
72511792|NCT06704178|144553740|SUPERIORITY||||||>|0.9999||||||Month 3 versus Baseline.|t-test, 2 sided|Within group analysis only.||||||>0.9999
72511793|NCT06704178|144553740|SUPERIORITY||||||>|0.9999||||||Month 4 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
72511794|NCT06704178|144553740|SUPERIORITY||||||>|0.9999||||||Month 5 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
72511795|NCT06704178|144553740|SUPERIORITY||||||>|0.9999||||||Month 6 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
72511796|NCT06704178|144553741|SUPERIORITY||||||>|0.9999||||||Month 1 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
72511797|NCT06704178|144553741|SUPERIORITY||||||>|0.9999||||||Month 2 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
72511798|NCT06704178|144553741|SUPERIORITY||||||>|0.9999||||||Month 3 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
72511799|NCT06704178|144553741|SUPERIORITY||||||>|0.9999||||||Month 4 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
72511800|NCT06704178|144553741|SUPERIORITY||||||>|0.9999||||||Month 5 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
72511801|NCT06704178|144553741|SUPERIORITY||||||>|0.9999||||||Month 6 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
72511802|NCT06704178|144553742|SUPERIORITY||||||>|0.9999||||||Month 1 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
72511803|NCT06704178|144553742|SUPERIORITY||||||>|0.9999||||||Month 2 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
72511804|NCT06704178|144553742|SUPERIORITY||||||>|0.9999||||||Month 3 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
72567217|NCT03265288|144665362|SUPERIORITY|||||||0.1955|||||||Log Rank|||||||0.1955
72483200|NCT03471871|144493186|OTHER||LS mean difference|0.002||||0.166|TWO_SIDED|95.0|-0.001|0.006||P-Value was at the 0.05 level of significance.|Mixed effect model|SPO2 was analyzed by mixed effect model, which included fixed effects for sequence, period, treatment a random effect for participant within sequence.||SpO2 is \<80%||0.006|-0.001|0.166
72511805|NCT06704178|144553742|SUPERIORITY||||||>|0.9999||||||Month 4 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
72511806|NCT06704178|144553742|SUPERIORITY||||||>|0.9999||||||Month 5 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
72511807|NCT06704178|144553742|SUPERIORITY||||||>|0.9999||||||Month 6 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
72511808|NCT06704178|144553743|SUPERIORITY||||||>|0.9999||||||Month 1 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
72511809|NCT06704178|144553743|SUPERIORITY||||||>|0.9999||||||Month 2 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
72511810|NCT06704178|144553743|SUPERIORITY||||||>|0.9999||||||Month 3 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
72511811|NCT06704178|144553743|SUPERIORITY||||||>|0.9999||||||Month 4 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
72511812|NCT06704178|144553743|SUPERIORITY||||||>|0.9999||||||Month 5 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
72511813|NCT06704178|144553743|SUPERIORITY||||||>|0.9999||||||Month 6 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
72511814|NCT06704178|144553744|SUPERIORITY||||||>|0.9999||||||Month 1 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
72511815|NCT06704178|144553744|SUPERIORITY||||||>|0.9999||||||Month 2 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
72511816|NCT06704178|144553744|SUPERIORITY||||||>|0.9999||||||Month 3 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
72511817|NCT06704178|144553744|SUPERIORITY||||||>|0.9999||||||Month 4 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
72511818|NCT06704178|144553744|SUPERIORITY||||||>|0.9999||||||Month 5 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
72511819|NCT06704178|144553744|SUPERIORITY||||||>|0.9999||||||Month 6 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
72511820|NCT06704178|144553745|SUPERIORITY||||||>|0.9999||||||Month 1 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
72511821|NCT06704178|144553745|SUPERIORITY||||||>|0.9999||||||Month 2 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
72511822|NCT06704178|144553745|SUPERIORITY||||||>|0.9999||||||Month 3 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
72402259|NCT01480076|144311668|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 12, Responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MSIS-29 psychological score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
72483201|NCT03471871|144493188|OTHER||LS mean difference|0.07||||0.699|TWO_SIDED|95.0|-0.31|0.46||P-Value was at the 0.05 level of significance.|mixed effect model|SPO2 was analyzed by mixed effect model, which included fixed effects for sequence, period, treatment a random effect for participant within sequence.||Day 1: Mean SpO2 during TST||0.46|-0.31|0.699
72483202|NCT03471871|144493188|OTHER||LS mean difference|0.25||||0.169|TWO_SIDED|95.0|-0.11|0.61||P-Value was at the 0.05 level of significance.|mixed effect model|SPO2 was analyzed by mixed effect model, which included fixed effects for sequence, period, treatment a random effect for participant within sequence.||Day 8: Mean SpO2 during TST||0.61|-0.11|0.169
72483203|NCT03471871|144493189|OTHER||LS mean difference|0.312||||0.472|TWO_SIDED|95.0|-0.558|1.181||P-Value was at the 0.05 level of significance.|mixed effect model|SPO2 was analyzed by mixed effect model, which included fixed effects for sequence, period, treatment a random effect for participant within sequence.||Day 1: SpO2 is \<90%||1.181|-0.558|0.472
72483204|NCT03471871|144493189|OTHER||LS mean difference|0.067||||0.479|TWO_SIDED|95.0|-0.124|0.258||P-Value was at the 0.05 level of significance.|mixed effect model|SPO2 was analyzed by mixed effect model, which included fixed effects for sequence, period, treatment a random effect for participant within sequence.||Day 1: SpO2 is \<85%||0.258|-0.124|0.479
72483205|NCT03471871|144493189|OTHER||LS mean difference|0.002||||0.852|TWO_SIDED|95.0|-0.019|0.023||P-Value was at the 0.05 level of significance.|mixed effect model|SPO2 was analyzed by mixed effect model, which included fixed effects for sequence, period, treatment a random effect for participant within sequence.||Day 1: SpO2 is \<80%||0.023|-0.019|0.852
72483206|NCT03471871|144493189|OTHER||LS mean difference|0.088||||0.733|TWO_SIDED|95.0|-0.431|0.607||P-Value was at the 0.05 level of significance.|mixed effect model|SPO2 was analyzed by mixed effect model, which included fixed effects for sequence, period, treatment a random effect for participant within sequence.||Day 8: SpO2 is \<90%||0.607|-0.431|0.733
72483207|NCT03471871|144493189|OTHER||LSM difference|0.056||||0.518|TWO_SIDED|95.0|-0.117|0.228||P-Value was at the 0.05 level of significance.|mixed effect model|SPO2 was analyzed by mixed effect model, which included fixed effects for sequence, period, treatment a random effect for participant within sequence.||Day 8: When SpO2 is \<85%||0.228|-0.117|0.518
72483208|NCT03471871|144493189|OTHER||LS mean difference|0.006||||0.576|TWO_SIDED|95.0|-0.015|0.026||P-Value was at the 0.05 level of significance.|mixed effect model|SPO2 was analyzed by mixed effect model, which included fixed effects for sequence, period, treatment a random effect for participant within sequence.||Day 8: SpO2 is \<80%||0.026|-0.015|0.576
72483209|NCT01117454|144493252|SUPERIORITY|||||||0.008|||||||Wilcoxon (Mann-Whitney)|Wilcoxon signed rank with continuity correction||||||0.008
72483210|NCT01681628|144493257|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|20.9|STANDARD_ERROR_OF_MEAN|2.0|<|0.001|TWO_SIDED|95.0|16.1|24.0||This was an a priori threshold.|t-test, 2 sided|||Means and differences were calculated for both groups before (time 1) and after treatment (or no treatment) (time 2). Also, the differences in mean scores from time 1 to 2 were compared between the two groups, the primary outcome. The numbers in the groups were considered adequate based on previous similar studies. The null hypothesis was that there would be no difference in any mean change in scores from time 1 to 2, between both groups.||24.0|16.1|<0.001
72483211|NCT01681628|144493257|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|32.4|STANDARD_DEVIATION|14.7|<|0.001|TWO_SIDED|95.0|29.1|34.7|||t-test, 2 sided|||Change in PCL-C scores from before to after treatment.||34.7|29.1|<0.001
72483212|NCT01681628|144493257|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.4|STANDARD_DEVIATION|14.2|<|0.001|TWO_SIDED|95.0|11.4|17.1|||t-test, 2 sided|||Changes in PCL-C scores for control group after no treatment.||17.1|11.4|<0.001
72483213|NCT01681628|144493257|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|20.6|STANDARD_DEVIATION|13.5|<|0.001|TWO_SIDED|95.0|17.1|22.5|||t-test, 2 sided|Degrees of freedom 94||Change in control group PCL-C scores after treatment, that is from time 2 to time 3.||22.5|17.1|<0.001
72483214|NCT01681628|144493258|SUPERIORITY_OR_OTHER||percentage of participants|65.7|||<|0.001|TWO_SIDED||||||Chi-squared|||Chi-squared test of any change in PCL-C from time 1 to time 2.||||<0.001
72483215|NCT01681628|144493258|SUPERIORITY_OR_OTHER||% of participants with PCL score > 50|41.0|||<|0.001|TWO_SIDED||||||Chi-squared|||Comparison of the percentage with diagnostic scores in the wait list group after no treatment at times 1 and 2.||||<0.001
72483216|NCT01681628|144493258|SUPERIORITY_OR_OTHER||Percentage|39.9|||<|0.001|TWO_SIDED||||||Chi-squared|||||||<0.001
72511823|NCT06704178|144553745|SUPERIORITY||||||>|0.9999||||||Month 4 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
72483217|NCT01681628|144493259|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|17.8|||<|0.001|TWO_SIDED|95.0|15.2|20.5|||t-test, 2 sided|||Both the original treatment and control groups were combined as both groups had been treated at a similar time before the nineteen month assessment. The null hypothesis was that there had been no change in the PCL-C scores at nineteen months compared to one week following treatment.||20.5|15.2|<0.001
72483218|NCT04682977|144493314|SUPERIORITY||Mean difference (adjusted)|1.58|STANDARD_ERROR_OF_MEAN|0.76||0.04|TWO_SIDED|||||Sidak correction for multiple comparisons.|ANCOVA|ANCOVA with baseline score as covariate Effect size calculated using Cohen's d|Treatment Difference = IPROACTIF-Control|||||0.04
72483219|NCT04682977|144493315|SUPERIORITY||Mean difference (adjusted)|1.98|STANDARD_ERROR_OF_MEAN|1.75||0.26|TWO_SIDED|||||Sidak correction for multiple comparisons|ANCOVA|ANCOVA with baseline score as covariate Effect size calculated using Cohen's d|Treatment Difference = IPROACTIF-Control|||||0.26
72483220|NCT04682977|144493316|SUPERIORITY||Mean difference (adjusted)|-1.06|STANDARD_ERROR_OF_MEAN|1.6||0.51|TWO_SIDED|||||Sidak correction for multiple comparisons|ANCOVA|ANCOVA with baseline score as covariate Effect size calculated using Cohen's d|Treatment Difference = IPROACTIF-Control|||||0.51
72483221|NCT04682977|144493317|SUPERIORITY||Mean difference (adjusted)|2.17|STANDARD_ERROR_OF_MEAN|1.78||0.23|TWO_SIDED|||||Sidak correction for multiple comparisons|ANCOVA|ANCOVA with baseline score as covariate Effect size calculated using Cohen's d|Treatment Difference = IPROACTIF - Control|||||0.23
72402260|NCT01480076|144311668|SUPERIORITY_OR_OTHER|||||||0.8202|||||||mixed effect model|||Month 12, Non-responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MSIS-29 psychological score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.8202
72483222|NCT04682977|144493318|SUPERIORITY||Mean difference (adjusted)|4.65|STANDARD_ERROR_OF_MEAN|5.97||0.44|TWO_SIDED|||||Sidak correction for multiple comparisons|ANCOVA|ANCOVA with baseline score as covariate Effect size calculated using Cohen's d|Treatment Difference = IPROACTIF - Control|||||0.44
72483223|NCT04682977|144493319|SUPERIORITY||Mean difference (adjusted)|4.37|STANDARD_ERROR_OF_MEAN|3.47||0.22|TWO_SIDED|||||Sidak correction for multiple comparisons|ANCOVA|ANCOVA with baseline score as covariate Effect size calculated using Cohen's d|Treatment Difference = IPROACTIF - Control|||||0.22
72483224|NCT04682977|144493320|SUPERIORITY||Mean difference (adjusted)|0.91|STANDARD_ERROR_OF_MEAN|1.8||0.91|TWO_SIDED|||||Sidak correction for multiple comparisons|ANCOVA|ANCOVA with baseline score as covariate Effect size calculated using Cohen's d|Treatment Difference = IPROACTIF - Control|||||0.91
72483225|NCT04682977|144493321|SUPERIORITY||Mean difference (adjusted)|0.18|STANDARD_ERROR_OF_MEAN|0.65||0.78|TWO_SIDED|||||Sidak correction for multiple comparisons|ANCOVA|ANCOVA with baseline score as covariate Effect size calculated using Cohen's d|Treatment Difference = IPROACTIF - Control|||||0.78
72483226|NCT04682977|144493322|SUPERIORITY||Mean difference (adjusted)|-0.12|STANDARD_ERROR_OF_MEAN|0.53||0.83|TWO_SIDED|||||Sidak correction for multiple comparisons|ANCOVA|ANCOVA with baseline score as covariate Effect size calculated using Cohen's d|Treatment Difference = IPROACTIF - Control|||||0.83
72483227|NCT04682977|144493323|SUPERIORITY|||||||0.67||||||The threshold for statistical significance was p = 0.05.|Wilcoxon (Mann-Whitney)|A non-parametric test was used due to non-normal distribution of data. Effect size calculated using rank biserial correlation r.||||||0.67
72511824|NCT06704178|144553745|SUPERIORITY||||||>|0.9999||||||Month 5 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
72511825|NCT06704178|144553745|SUPERIORITY||||||>|0.9999||||||Month 6 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
72511826|NCT06704178|144553746|SUPERIORITY||||||>|0.9999||||||Month 1 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
72511827|NCT06704178|144553746|SUPERIORITY||||||>|0.9999||||||Month 2 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
72511828|NCT06704178|144553746|SUPERIORITY||||||>|0.9999||||||Month 3 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
72511829|NCT06704178|144553746|SUPERIORITY||||||>|0.9999||||||Month 4 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
72511830|NCT06704178|144553746|SUPERIORITY||||||>|0.9999||||||Month 5 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
72511831|NCT06704178|144553746|SUPERIORITY||||||>|0.9999||||||Month 6 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
72483228|NCT04682977|144493324|SUPERIORITY|||||||0.77||||||The threshold for statistical significance was p = 0.05.|Wilcoxon (Mann-Whitney)|A non-parametric test was used due to non-normal distribution of data. Effect size calculated using rank biserial correlation r.||||||0.77
72483229|NCT04682977|144493325|SUPERIORITY|||||||0.79||||||The threshold for statistical significance was p = 0.05.|Wilcoxon (Mann-Whitney)|A non-parametric test was used due to non-normal distribution of data. Effect size calculated using rank biserial correlation r.||||||0.79
72483230|NCT04682977|144493326|SUPERIORITY|||||||0.44||||||The threshold for statistical significance was p = 0.05.|Wilcoxon (Mann-Whitney)|A non-parametric test was used due to non-normal distribution of data. Effect size calculated using rank biserial correlation r.||||||0.44
72483231|NCT04682977|144493327|SUPERIORITY|||||||0.65||||||The threshold for statistical significance was p = 0.05|Wilcoxon (Mann-Whitney)|A non-parametric test was used due to non-normal distribution of data. Effect size calculated using rank biserial correlation r||||||0.65
72511832|NCT06704178|144553747|SUPERIORITY||||||>|0.9999||||||Month 1 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
72511833|NCT06704178|144553747|SUPERIORITY||||||>|0.9999||||||Month 2 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
72511834|NCT06704178|144553747|SUPERIORITY||||||>|0.9999||||||Month 3 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
72511835|NCT06704178|144553747|SUPERIORITY||||||>|0.9999||||||Month 4 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
72511836|NCT06704178|144553747|SUPERIORITY||||||>|0.9999||||||Month 5 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
72511837|NCT06704178|144553747|SUPERIORITY|||||||0.982||||||Month 6 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.982
72511838|NCT06704178|144553748|SUPERIORITY||||||>|0.9999||||||Month 1 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
72511839|NCT06704178|144553748|SUPERIORITY||||||>|0.9999||||||Month 2 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
72511840|NCT06704178|144553748|SUPERIORITY||||||>|0.9999||||||Month 3 vs Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
72511841|NCT06704178|144553748|SUPERIORITY||||||>|0.9999||||||Month 4 vs Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
72511842|NCT06704178|144553748|SUPERIORITY||||||>|0.9999||||||Month 5 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
72511843|NCT06704178|144553748|SUPERIORITY||||||>|0.9999||||||Month 6 vs Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
72511844|NCT06704178|144553749|SUPERIORITY||||||>|0.9999||||||Month 1 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
72511845|NCT06704178|144553749|SUPERIORITY|||||||0.9951||||||Month 2 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.9951
72511846|NCT06704178|144553749|SUPERIORITY|||||||0.999||||||Month 3 versus Baseline|t-test, 2 sided|Within-group analysis only.||||||0.999
72511847|NCT06704178|144553749|SUPERIORITY|||||||0.9913||||||Month 4 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.9913
72511848|NCT06704178|144553749|SUPERIORITY|||||||0.4517||||||Month 5 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.4517
72511849|NCT06704178|144553749|SUPERIORITY|||||||0.8187||||||Month 6 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.8187
72511850|NCT06704178|144553750|SUPERIORITY|||||||0.998||||||Month 1 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.998
72483232|NCT04682977|144493328|SUPERIORITY|||||||0.66||||||The threshold for statistical significance was p = 0.05.|Wilcoxon (Mann-Whitney)|A non-parametric test was used due to non-normal distribution of data. Effect size calculated using rank biserial correlation r.||||||0.66
72483233|NCT04682977|144493329|SUPERIORITY|||||||0.81||||||The threshold for statistical significance was p = 0.05.|Wilcoxon (Mann-Whitney)|A non-parametric test was used due to non-normal distribution of data. Effect size calculated using rank biserial correlation r.||||||0.81
72483234|NCT04682977|144493330|SUPERIORITY|||||||0.89||||||The threshold for statistical significance was p = 0.05.|Wilcoxon (Mann-Whitney)|A non-parametric test was used due to non-normal distribution of data. Effect size calculated using rank biserial correlation r.||||||0.89
72483235|NCT01383161|144493331|SUPERIORITY|||||||0.5|||||||mixed-effects general linear model|||||||0.5
72483236|NCT01383161|144493331|SUPERIORITY|||||||0.01|||||||t-test, 2 sided|||||||0.01
72483237|NCT01383161|144493331|SUPERIORITY|||||||0.2|||||||t-test, 2 sided|||||||0.2
72483238|NCT01383161|144493332|SUPERIORITY|||||||0.08|||||||mixed-effects general linear model|||||||0.08
72483239|NCT01383161|144493332|SUPERIORITY|||||||0.006|||||||t-test, 2 sided|||||||.006
72483240|NCT01383161|144493332|SUPERIORITY|||||||0.8|||||||t-test, 2 sided|||||||0.8
72483241|NCT01383161|144493333|SUPERIORITY|||||||0.05|||||||mixed-effects general linear model|||||||0.05
72483242|NCT01383161|144493333|SUPERIORITY|||||||0.002|||||||t-test, 2 sided|||||||0.002
72483243|NCT01383161|144493333|SUPERIORITY|||||||0.8|||||||t-test, 2 sided|||||||0.8
72483244|NCT01383161|144493334|SUPERIORITY|||||||0.08|||||||mixed-effects general linear model|||||||0.08
72511851|NCT06704178|144553750|SUPERIORITY|||||||0.9591||||||Month 2 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.9591
72483245|NCT01383161|144493334|SUPERIORITY|||||||0.002|||||||t-test, 2 sided|||||||.002
72483246|NCT01383161|144493334|SUPERIORITY|||||||0.5|||||||t-test, 2 sided|||||||0.5
72483247|NCT01383161|144493335|SUPERIORITY|||||||0.04|||||||mixed-effects general linear model|||||||0.04
72483248|NCT01383161|144493335|SUPERIORITY|||||||0.0001|||||||t-test, 2 sided|||||||0.0001
72483249|NCT01383161|144493335|SUPERIORITY|||||||0.1|||||||t-test, 2 sided|||||||0.1
72483250|NCT01383161|144493336|SUPERIORITY|||||||0.3|||||||mixed-effects general linear model|||||||0.3
72483251|NCT01383161|144493336|SUPERIORITY|||||||0.04|||||||t-test, 2 sided|||||||0.04
72483252|NCT01383161|144493336|SUPERIORITY|||||||0.6|||||||t-test, 2 sided|||||||0.6
72483253|NCT03801902|144493391|OTHER||||||||||||||||||"If 0-1 of initial 6 evaluable patients on an arm have a safety event, then the regimen will be deemed safe and that arm will continue to the second part of the study to enroll 6 additional evaluable patients. However, if 2 or more of the 6 patients develop a safety event, then that arm is considered not safe and will not continue to second part. The probability of the treatment being judged to be too toxic when the true toxicity rate is ≥ 40% is at least 77%. If the true toxicity rate is ≤ 18%, then the probability that the treatment will be deemed to be safe is at least 70%.~If fewer than 4 of the total of 12 evaluable patients on an arm experience a safety event, then the treatment will be considered tolerable. With a cohort of 12 patients, the probability of the treatment being judged to be too toxic when the true toxicity rate is ≥ 40% at least 78%. If the true toxicity rate is ≤ 18%, the probability that the treatment will be deemed to be safe is 85%."|||
72483254|NCT02876835|144493416|NON_INFERIORITY|Non-inferiority was achieved if the upper limit of the two-sided 95% CI for the hazard ratio was below the pre-specified non-inferiority margin of 1.25.|Hazard Ratio (HR)|1.03|||||TWO_SIDED|95.0|0.89|1.19|||||Hazard ratio was estimated using a Cox proportional hazard regression model with treatment group, current ESA use at randomization, and region as covariates.|||1.19|0.89|
72511852|NCT06704178|144553750|SUPERIORITY|||||||0.9994||||||Month 3 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.9994
72511853|NCT06704178|144553750|SUPERIORITY|||||||0.9936||||||Month 4 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.9936
72511854|NCT06704178|144553750|SUPERIORITY|||||||0.8526||||||Month 5 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.8526
72511855|NCT06704178|144553750|SUPERIORITY|||||||0.4375||||||Month 6 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.4375
72511856|NCT06704178|144553751|SUPERIORITY||||||>|0.9999||||||Month 1 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
72511857|NCT06704178|144553751|SUPERIORITY|||||||0.7477||||||Month 2 versus Baseline.|t-test, 2 sided|Within-group analysis.||||||0.7477
72511858|NCT06704178|144553751|SUPERIORITY|||||||0.297||||||Month 3 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.297
72511859|NCT06704178|144553751|SUPERIORITY|||||||0.3503||||||Month 4 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.3503
72511860|NCT06704178|144553751|SUPERIORITY|||||||0.297||||||Month 5 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.297
72511861|NCT06704178|144553751|SUPERIORITY|||||||0.4449||||||Month 6 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.4449
72511862|NCT06704178|144553752|SUPERIORITY||||||>|0.9999||||||Month 1 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
72511863|NCT06704178|144553752|SUPERIORITY||||||>|0.9999||||||Month 2 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
72483255|NCT02876835|144493417|NON_INFERIORITY|Non-inferiority was to be established if the lower limit of the two-sided 95% CI for the treatment difference was greater than -0.75 g/dL.|Least square (LS) mean difference|0.08|||||TWO_SIDED|95.0|0.03|0.13||||||||0.13|0.03|
72483256|NCT02876835|144493418|SUPERIORITY||Hazard Ratio (HR)|1.03||||0.670884|TWO_SIDED|95.0|0.89|1.19||The p-value was compared against 0.008333 based on the Holm-Bonferonni adjustment.|Wald test||Hazard ratio was estimated using a Cox proportional hazard regression model with treatment group, current ESA use at randomization, and region as covariates.|||1.19|0.89|0.670884
72483257|NCT02876835|144493419|SUPERIORITY||Hazard Ratio (HR)|1.06||||0.800813|TWO_SIDED|95.0|0.93|1.22||The p-value was compared against 0.012500 based on the Holm-Bonferonni adjustment.|Wald test||Hazard ratio was estimated using a Cox proportional hazard regression model with treatment group, current ESA use at randomization, and region as covariates.|||1.22|0.93|0.800813
72483258|NCT02876835|144493420|SUPERIORITY||Hazard Ratio (HR)|1.09||||0.886195|TWO_SIDED|95.0|0.95|1.24||The p-value was compared against 0.025000 based on the Holm-Bonferonni adjustment.|Wald test||Hazard ratio was estimated using a Cox proportional hazard regression model with treatment group, current ESA use at randomization, and region as covariates.|||1.24|0.95|0.886195
72483259|NCT02876835|144493421|SUPERIORITY||Subdistribution hazard ratio|0.98||||0.36947|TWO_SIDED|95.0|0.84|1.13|||Wald test||Subdistribution hazard ratio was estimated using Fine and Gray's proportional subdistribution hazard regression model with treatment group, Baseline ESA use, and region as covariates.|||1.13|0.84|0.369470
72483260|NCT02876835|144493422|SUPERIORITY||Hazard Ratio (HR)|1.03||||0.6197|TWO_SIDED|95.0|0.87|1.2|||Wald test||Hazard ratio was estimated using a Cox proportional hazard regression model with treatment group, current ESA use at randomization, and region as covariates.|||1.20|0.87|0.6197
72483261|NCT02876835|144493423|SUPERIORITY||Hazard Ratio (HR)|1.2||||0.8976|TWO_SIDED|95.0|0.91|1.58|||Wald test||Hazard ratio was estimated using a Cox proportional hazard regression model with treatment group, current ESA use at randomization, and region as covariates.|||1.58|0.91|0.8976
72483262|NCT02876835|144493424|SUPERIORITY||Hazard Ratio (HR)|1.06||||0.6581|TWO_SIDED|95.0|0.8|1.4|||Wald test||Hazard ratio was estimated using a Cox proportional hazard regression model with treatment group, current ESA use at randomization, and region as covariates.|||1.40|0.80|0.6581
72483263|NCT02876835|144493425|SUPERIORITY||Hazard Ratio (HR)|1.33||||0.894|TWO_SIDED|95.0|0.85|2.07|||Wald test||Hazard ratio was estimated using a Cox proportional hazard regression model with treatment group, current ESA use at randomization, and region as covariates.|||2.07|0.85|0.8940
72483264|NCT02876835|144493426|SUPERIORITY||Hazard Ratio (HR)|1.1||||0.9422|TWO_SIDED|95.0|0.98|1.23|||Chi-squared||Overall HR is presented using Model 1. Model 1 assumed a common treatment effect, regardless of number of events experienced. HR was estimated using a Prentice, Williams and Peterson(PWP) model, with treatment, dialysis type and region as covariates.|||1.23|0.98|0.9422
72483265|NCT02876835|144493426|SUPERIORITY||Hazard Ratio (HR)|1.09||||0.8862|TWO_SIDED|95.0|0.95|1.24|||Chi-squared||First Event Hazard ratio is presented using Model 2. Model 2 assumed treatment effect differs by number of events experienced. Hazard Ratio (HR) was estimated using a PWP model, with treatment, dialysis type and region as covariates.|||1.24|0.95|0.8862
72483266|NCT02876835|144493426|SUPERIORITY||Hazard Ratio (HR)|1.07||||0.6789|TWO_SIDED|95.0|0.82|1.39|||Chi-squared||Second Event Hazard ratio is presented using Model 2. Model 2 assumed treatment effect differs by number of events experienced. HR was estimated using a PWP model, with treatment, dialysis type and region as covariates.|||1.39|0.82|0.6789
72483267|NCT02876835|144493426|SUPERIORITY||Hazard Ratio (HR)|1.37||||0.9016|TWO_SIDED|95.0|0.85|2.19|||Chi-squared||Third Event Hazard ratio is presented using Model 2. Model 2 assumed treatment effect differs by number of events experienced. HR was estimated using a PWP model, with treatment, dialysis type and region as covariates.|||2.19|0.85|0.9016
72483268|NCT02876835|144493426|SUPERIORITY||Hazard Ratio (HR)|1.09||||0.8862|TWO_SIDED|95.0|0.95|1.24|||Chi-squared||First Event Hazard ratio is presented using Model 3. Model 3 assumed treatment effect for first event differs from a common effect for subsequent events. HR was estimated using a PWP model, with treatment, dialysis type and region as covariates.|||1.24|0.95|0.8862
72511864|NCT06704178|144553752|SUPERIORITY|||||||0.9188||||||Month 3 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.9188
72483269|NCT02876835|144493426|SUPERIORITY||Hazard Ratio (HR)|1.16||||0.8989|TWO_SIDED|95.0|0.92|1.46|||Chi-squared||Subsequent Event Hazard ratio is presented using Model 3. Model 3 assumed treatment effect for first event differs from a common effect for subsequent events. HR was estimated using a PWP model, with treatment, dialysis type and region as covariates.|||1.46|0.92|0.8989
72483270|NCT02876835|144493427|SUPERIORITY||Hazard Ratio (HR)|1.08||||0.7673|TWO_SIDED|95.0|0.88|1.33|||Wald test||Hazard ratio was estimated using a Cox proportional hazard regression model with treatment group, current ESA use at randomization, and region as covariates.|||1.33|0.88|0.7673
72483271|NCT02876835|144493428|SUPERIORITY||Hazard Ratio (HR)|1.05||||0.8601|TWO_SIDED|95.0|0.96|1.15|||Wald test||Hazard ratio was estimated using a Cox proportional hazard regression model with treatment group, current ESA use at randomization, and region as covariates.|||1.15|0.96|0.8601
72511865|NCT06704178|144553752|SUPERIORITY||||||>|0.9999||||||Month 4 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
72483272|NCT02876835|144493429|SUPERIORITY||Hazard Ratio (HR)|1.03||||0.6207|TWO_SIDED|95.0|0.86|1.22|||Wald test||Hazard ratio was estimated using a Cox proportional hazard regression model with treatment group, current ESA use at randomization, and region as covariates.|||1.22|0.86|0.6207
72483273|NCT02876835|144493430|SUPERIORITY||Hazard Ratio (HR)|1.11||||0.9393|TWO_SIDED|95.0|0.97|1.26|||Wald test||Hazard ratio was estimated using a Cox proportional hazard regression model with treatment group, current ESA use at randomization, and region as covariates.|||1.26|0.97|0.9393
72483274|NCT02876835|144493431|SUPERIORITY||Hazard Ratio (HR)|1.22||||0.9412|TWO_SIDED|95.0|0.95|1.56|||Wald test||Hazard ratio was estimated using a Cox proportional hazard regression model with treatment group, current ESA use at randomization, and region as covariates.|||1.56|0.95|0.9412
72511866|NCT06704178|144553752|SUPERIORITY|||||||0.3503||||||Month 5 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.3503
72511867|NCT06704178|144553752|SUPERIORITY||||||>|0.9999||||||Month 6 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
72483275|NCT02876835|144493432|SUPERIORITY||Hazard Ratio (HR)|1.27||||0.8994|TWO_SIDED|95.0|0.88|1.84|||Wald test||Hazard ratio was estimated using a Cox proportional hazard regression model with treatment group, current ESA use at randomization, and region as covariates.|||1.84|0.88|0.8994
72483276|NCT02876835|144493433|SUPERIORITY||Subdistribution hazard ratio|0.92||||0.2073|TWO_SIDED|95.0|0.75|1.13|||Wald test||Subdistribution hazard ratio was estimated using Fine \& Gray's proportional subdistribution hazard regression model with treatment group, Baseline ESA use, and region as covariates.|||1.13|0.75|0.2073
72483277|NCT02876835|144493434|SUPERIORITY||Subdistribution hazard ratio|1.0||||0.5068|TWO_SIDED|95.0|0.84|1.19|||Wald test||Subdistribution hazard ratio was estimated using Fine \& Gray's proportional subdistribution hazard regression model with treatment group, Baseline ESA use, and region as covariates.|||1.19|0.84|0.5068
72483278|NCT02876835|144493435|SUPERIORITY||Subdistribution hazard ratio|0.88||||0.3285|TWO_SIDED|95.0|0.51|1.54|||Wald test||Subdistribution hazard ratio was estimated using Fine \& Gray's proportional subdistribution hazard regression model with treatment group, Baseline ESA use, and region as covariates.|||1.54|0.51|0.3285
72483279|NCT02876835|144493436|NON_INFERIORITY|Non-inferiority was to be established if the lower limit of the two-sided 95% CI for the treatment difference was greater than the pre-specified non-inferiority margin of -0.75 g/dL.|LS mean difference|0.03|||||TWO_SIDED|95.0|-0.05|0.11||||||||0.11|-0.05|
72483280|NCT02876835|144493437|SUPERIORITY||Difference in response rate|8.3|||<|0.0001|TWO_SIDED|95.0|5.2|11.4|||Cochran-Mantel-Haenszel||Cochran-Mantel-Haenszel (CMH) test adjusted for current ESA use and region was used to compare the number of responders between the treatment groups.|||11.4|5.2|<0.0001
72483281|NCT02876835|144493438|NON_INFERIORITY|Non-inferiority was to be established if the lower limit of the two-sided 95% confidence interval for the treatment difference was greater than non-inferiority margin of -15%.|Mean Difference (Final Values)|4.57|||||TWO_SIDED|95.0|2.04|7.11|||||Hodges-Lehmann estimate of the treatment difference (daprodustat-darbepoetin alfa) and associated two-sided asymptotic 95% CI is presented.|||7.11|2.04|
72483282|NCT02876835|144493439|SUPERIORITY||Probability|0.55|||<|0.0001|TWO_SIDED|95.0|0.53|0.57|||van Elteren test||Mann-Whitney estimate (Probability) of the treatment effect has been presented.|||0.57|0.53|<0.0001
72483283|NCT02876835|144493440|NON_INFERIORITY|Non-inferiority was to be established if the lower limit of the two-sided 95% confidence interval for the treatment difference was greater than non-inferiority margin of -15%.|Median Difference (Final Values)|3.94|||||TWO_SIDED|95.0|1.9|5.91|||||Hodges-Lehmann estimate of the treatment difference (daprodustat-darbepoetin alfa) and associated two-sided asymptotic 95% CI is presented.|||5.91|1.90|
72483284|NCT02876835|144493441|SUPERIORITY||Probability|0.54|||<|0.0001|TWO_SIDED|95.0|0.52|0.56|||van Elteren test||Mann-Whitney estimate (Probability) of the treatment effect has been presented.|||0.56|0.52|<0.0001
72483285|NCT02876835|144493442|SUPERIORITY||LS mean difference|0.56||||0.7916|TWO_SIDED|95.0|-0.79|1.9|||MMRM||The difference in change from Baseline in SBP at Week 52 was analyzed with a MMRM approach with an unstructured covariance matrix to compare the difference in LS means between arms.|||1.90|-0.79|0.7916
72483286|NCT02876835|144493442|SUPERIORITY||LS mean difference|0.65||||0.9581|TWO_SIDED|95.0|-0.09|1.38|||MMRM||The difference in change from Baseline in DBP at Week 52 was analyzed with a MMRM approach with an unstructured covariance matrix to compare the difference in LS means between arms.|||1.38|-0.09|0.9581
72483287|NCT02876835|144493442|SUPERIORITY||LS mean difference|0.6||||0.9241|TWO_SIDED|95.0|-0.22|1.43|||MMRM||The difference in change from Baseline in MAP at Week 52 was analyzed with a MMRM approach with an unstructured covariance matrix to compare the difference in LS means between arms.|||1.43|-0.22|0.9241
72483288|NCT02876835|144493443|SUPERIORITY||LS mean difference|-0.08||||0.442|TWO_SIDED|95.0|-1.18|1.02|||ANCOVA||For SBP: Treatment group comparisons were based on an ANCOVA model with terms for treatment group, current ESA use at randomization, region and Baseline value.|||1.02|-1.18|0.4420
72483289|NCT02876835|144493443|SUPERIORITY||LS mean difference|0.11||||0.6369|TWO_SIDED|95.0|-0.52|0.75|||ANCOVA||For DBP: Treatment group comparisons were based on an ANCOVA model with terms for treatment group, current ESA use at randomization, region and Baseline value.|||0.75|-0.52|0.6369
72483290|NCT02876835|144493443|SUPERIORITY||LS mean difference|0.04||||0.549|TWO_SIDED|95.0|-0.65|0.74|||ANCOVA||For MAP: Treatment group comparisons were based on an ANCOVA model with terms for treatment group, current ESA use at randomization, region and Baseline value.|||0.74|-0.65|0.5490
72483291|NCT02876835|144493444|SUPERIORITY||Ratio of exacerbation rate|0.88||||0.0074|TWO_SIDED|95.0|0.79|0.98|||Negative binomial model||Ratio of model estimated exacerbation rates and CIs estimated using negative binomial model with treatment,current ESA use at randomization and region as covariates and logarithm of time on treatment as offset variable for treatment group comparison.|||0.98|0.79|0.0074
72483292|NCT02876835|144493446|SUPERIORITY||Hazard Ratio (HR)|0.63||||0.0113|TWO_SIDED|95.0|0.42|0.94|||Wald test||Hazard ratio was estimated using a Cox proportional hazard regression model adjusted for treatment group, current ESA use and region.|||0.94|0.42|0.0113
72567218|NCT03265288|144665363|SUPERIORITY||Risk Ratio (RR)|1.35||||0.1909|TWO_SIDED|95.0|0.86|2.12||alpha is set to 0.05|Poisson regression||Odds ratio \< 1 means lower odds of an antibiotic treatment with LAU-7b, odds ratio \> 1 means higher odds of an antibiotic treatment with LAU-7b|Number per subject of intravenous antibiotic treatments required for a pulmonary exacerbation, excludes Cycle 1 pulmonary exacerbations Intent to treat population (ITT), null hypothesis is no treatment effect||2.12|0.86|0.1909
72483293|NCT02876835|144493447|SUPERIORITY||LS mean difference|-0.36||||0.932|TWO_SIDED|95.0|-0.83|0.11|||MMRM||Week8:Model was fitted from Baseline up to Week52 and model adjusted Week8 data has been presented, with factors for treatment, time,current ESA use at randomization, region,Baseline value and Baseline value by time and treatment by time interactions|||0.11|-0.83|0.9320
72483294|NCT02876835|144493447|SUPERIORITY||LS mean difference|-0.11||||0.6761|TWO_SIDED|95.0|-0.59|0.36|||MMRM||Week12:Model was fitted from Baseline up to Week52 and model adjusted Week12 data has been presented,with factors for treatment, time,current ESA use at randomization, region, Baseline value and Baseline value by time \& treatment by time interactions|||0.36|-0.59|0.6761
72483295|NCT02876835|144493447|SUPERIORITY||LS mean difference|0.12||||0.3335|TWO_SIDED|95.0|-0.43|0.67|||MMRM||Week28:Model was fitted from Baseline up to Week52 and model adjusted Week28 data has been presented,with factors for treatment, time,current ESA use at randomization, region, Baseline value and Baseline value by time \& treatment by time interactions|||0.67|-0.43|0.3335
72402261|NCT01480076|144311668|SUPERIORITY_OR_OTHER||least squares mean|-6.4|STANDARD_ERROR_OF_MEAN|2.28||0.0049|TWO_SIDED||||||mixed effect model|||Month 12, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MSIS-29 psychological score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0049
72402262|NCT01480076|144311669|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Overall, Responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of the total activity limitation score of PRIMUS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
72402263|NCT01480076|144311669|SUPERIORITY_OR_OTHER|||||||0.1324|||||||mixed effect model|||Overall, Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of the total activity limitation score of PRIMUS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.1324
72402264|NCT01480076|144311669|SUPERIORITY_OR_OTHER||least squares mean|-2.3|STANDARD_ERROR_OF_MEAN|0.56|<|0.0001|TWO_SIDED||||||mixed effect model|||Overall, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of the total activity limitation score of PRIMUS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
72402265|NCT01480076|144311669|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 3, Responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of the total activity limitation score of PRIMUS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
72402266|NCT01480076|144311669|SUPERIORITY_OR_OTHER|||||||0.4759|||||||mixed effect model|||Month 3, Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of the total activity limitation score of PRIMUS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.4759
72402267|NCT01480076|144311669|SUPERIORITY_OR_OTHER||least squares mean|-1.9|STANDARD_ERROR_OF_MEAN|0.59||0.0016|TWO_SIDED||||||mixed effect model|||Month 3, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of the total activity limitation score of PRIMUS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0016
72402268|NCT01480076|144311669|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 6, Responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of the total activity limitation score of PRIMUS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error||||<0.0001
72402269|NCT01480076|144311669|SUPERIORITY_OR_OTHER|||||||0.2489|||||||mixed effect model|||Month 6, Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of the total activity limitation score of PRIMUS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.2489
72483296|NCT02876835|144493447|SUPERIORITY||LS mean difference|-0.2||||0.7423|TWO_SIDED|95.0|-0.81|0.41|||MMRM||Week52:Model was fitted from Baseline up to Week52 and model adjusted Week52 data has been presented,with factors for treatment, time,current ESA use at randomization, region, Baseline value and Baseline value by time \& treatment by time interactions|||0.41|-0.81|0.7423
72483297|NCT02876835|144493448|SUPERIORITY||LS mean difference|-0.29||||0.8268|TWO_SIDED|95.0|-0.9|0.32|||MMRM||Week8:Model was fitted from Baseline up to Week52 and model adjusted Week8 data has been presented,with factors for treatment, time,current ESA use at randomization, region, Baseline value and Baseline value by time \& treatment by time interactions.|||0.32|-0.90|0.8268
72483298|NCT02876835|144493448|SUPERIORITY||LS mean difference|-0.15||||0.6851|TWO_SIDED|95.0|-0.77|0.47|||MMRM||Week12:Model was fitted from Baseline up to Week52 and model adjusted Week12 data has been presented,with factors for treatment, time,current ESA use at randomization, region, Baseline value and Baseline value by time \& treatment by time interactions|||0.47|-0.77|0.6851
72483299|NCT02876835|144493448|SUPERIORITY||LS mean difference|-0.33||||0.8316|TWO_SIDED|95.0|-1.01|0.35|||MMRM||Week28:Model was fitted from Baseline up to Week52 and model adjusted Week28 data has been presented,with factors for treatment, time,current ESA use at randomization, region, Baseline value and Baseline value by time \& treatment by time interactions|||0.35|-1.01|0.8316
72483300|NCT02876835|144493448|SUPERIORITY||LS mean difference|-0.35||||0.8032|TWO_SIDED|95.0|-1.16|0.46|||MMRM||Week52:Model was fitted from Baseline up to Week52 and model adjusted Week52 data has been presented,with factors for treatment, time,current ESA use at randomization, region, Baseline value and Baseline value by time \& treatment by time interactions|||0.46|-1.16|0.8032
72483301|NCT02876835|144493449|SUPERIORITY||LS mean difference|-0.34||||0.8562|TWO_SIDED|95.0|-0.95|0.28|||MMRM||B pain,Week8:Model was fitted from Baseline up to Week52 and model adjusted Week8 data has been presented, with factors for treatment, time, current ESA use at randomization, region, BL value and BL value by time \& treatment by time interactions.|||0.28|-0.95|0.8562
72402270|NCT01480076|144311669|SUPERIORITY_OR_OTHER||least squares mean|-2.2|STANDARD_ERROR_OF_MEAN|0.71||0.0017|TWO_SIDED||||||mixed effect model|||Month 6, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of the total activity limitation score of PRIMUS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0017
72402271|NCT01480076|144311669|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 9, Responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of the total activity limitation score of PRIMUS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
72402272|NCT01480076|144311669|SUPERIORITY_OR_OTHER|||||||0.0126|||||||mixed effect model|||Month 9, Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of the total activity limitation score of PRIMUS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0126
72511868|NCT03675737|144553765|SUPERIORITY||Hazard Ratio (HR)|0.78|||<|0.0001|TWO_SIDED|95.0|0.7|0.87||One-sided p-value based on log-rank test stratified by geographic region, Programmed Cell Death Ligand 1 (PD-L1) status (Combined Positive Score \[CPS\] \<1 versus CPS ≥1), and chemotherapy regimen with small strata collapsed.|Log Rank||Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by geographic region, PD-L1 status (CPS \<1 versus CPS ≥1), and chemotherapy regimen with small strata collapsed.|||0.87|0.70|<0.0001
72511869|NCT03675737|144553766|SUPERIORITY||Hazard Ratio (HR)|0.74|||<|0.0001|TWO_SIDED|95.0|0.65|0.84||One-sided p-value based on log-rank test stratified by geographic region and chemotherapy regimen with small strata collapsed.|Log Rank||Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by geographic region and chemotherapy regimen with small strata collapsed.|||0.84|0.65|<0.0001
72511870|NCT03675737|144553767|SUPERIORITY||Hazard Ratio (HR)|0.65|||<|0.0001|TWO_SIDED|95.0|0.53|0.79||One-sided p-value based on log-rank test stratified by geographic region and chemotherapy regimen with small strata collapsed.|Log Rank||Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by geographic region and chemotherapy regimen with small strata collapsed.|||0.79|0.53|<0.0001
72511871|NCT03675737|144553768|SUPERIORITY||Hazard Ratio (HR)|0.76|||<|0.0001|TWO_SIDED|95.0|0.67|0.85||One-sided p-value based on log-rank test stratified by geographic region, Programmed Cell Death Ligand 1 (PD-L1) status (Combined Positive Score \[CPS\] \<1 versus CPS ≥1), and chemotherapy regimen with small strata collapsed.|Log Rank||Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by geographic region, PD-L1 status (CPS \<1 versus CPS ≥1), and chemotherapy regimen with small strata collapsed.|||0.85|0.67|<0.0001
72511872|NCT03675737|144553769|SUPERIORITY||Hazard Ratio (HR)|0.72|||<|0.0001|TWO_SIDED|95.0|0.63|0.82||One-sided p-value based on log-rank test stratified by geographic region and chemotherapy regimen with small strata collapsed.|Log Rank||Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by geographic region and chemotherapy regimen with small strata collapsed.|||0.82|0.63|<0.0001
72511873|NCT03675737|144553770|SUPERIORITY||Hazard Ratio (HR)|0.62|||<|0.0001|TWO_SIDED|95.0|0.51|0.76||One-sided p-value based on log-rank test stratified by geographic region and chemotherapy regimen with small strata collapsed.|Log Rank||Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by geographic region and chemotherapy regimen with small strata collapsed.|||0.76|0.51|<0.0001
72511874|NCT03675737|144553771|SUPERIORITY||Difference in Percentage|9.3||||9e-05|TWO_SIDED|95.0|4.4|14.1||One-sided p-value based on Miettinen \& Nurminen method stratified by geographic region, Programmed Cell Death Ligand 1 (PD-L1) status (Combined Positive Score \[CPS\] \<1 versus CPS ≥1), and chemotherapy regimen with small strata collapsed.|Miettinen & Nurminen method||Based on Miettinen \& Nurminen method stratified by geographic region, PD-L1 status (CPS \<1 versus CPS ≥1), and chemotherapy regimen with small strata collapsed.|||14.1|4.4|0.00009
72511875|NCT03675737|144553772|SUPERIORITY||Difference in Percentage|9.5||||0.00041|TWO_SIDED|95.0|3.9|15.0||One-sided p-value based on Miettinen \& Nurminen method stratified by geographic region and chemotherapy regimen with small strata collapsed.|Miettinen & Nurminen method||Based on Miettinen \& Nurminen method stratified by geographic region and chemotherapy regimen with small strata collapsed.|||15.0|3.9|0.00041
72511876|NCT03675737|144553773|SUPERIORITY||Difference in Percentage|17.5||||2e-05|TWO_SIDED|95.0|9.3|25.5||One-sided p-value based on Miettinen \& Nurminen method stratified by geographic region and chemotherapy regimen with small strata collapsed.|Miettinen & Nurminen method||Based on Miettinen \& Nurminen method stratified by geographic region and chemotherapy regimen with small strata collapsed.|||25.5|9.3|0.00002
72511877|NCT02922634|144553808|SUPERIORITY|||||||0.508|||||||Wilcoxon (Mann-Whitney)|||||||0.508
72511878|NCT02922634|144553809|SUPERIORITY|||||||0.72||||||The chi-squared test for both males and females with and without delirium.|Chi-squared|||||||0.720
72511879|NCT02922634|144553810|SUPERIORITY|||||||0.025|||||||Wilcoxon (Mann-Whitney)|||||||0.025
72511880|NCT02922634|144553811|SUPERIORITY|||||||0.48|||||||Chi-squared|||||||0.480
72511881|NCT02922634|144553812|SUPERIORITY|||||||0.028|||||||Chi-squared|||||||0.028
72511882|NCT02922634|144553813|SUPERIORITY|||||||0.007|||||||Chi-squared|||||||0.007
72511883|NCT02922634|144553814|SUPERIORITY|||||||0.002|||||||Wilcoxon (Mann-Whitney)|||||||0.002
72511884|NCT02922634|144553815|SUPERIORITY|||||||0.01|||||||Chi-squared|||||||0.01
72511885|NCT02922634|144553816|SUPERIORITY|||||||0.101|||||||Chi-squared|||||||0.101
72511886|NCT02922634|144553817|SUPERIORITY|||||||0.192|||||||Chi-squared|||||||0.192
72511887|NCT02922634|144553818|SUPERIORITY|||||||0.2|||||||Chi-squared|||||||0.200
72511888|NCT02922634|144553819|SUPERIORITY|||||||0.333|||||||Wilcoxon (Mann-Whitney)|||||||0.333
72511889|NCT02922634|144553820|SUPERIORITY|||||||0.001||||||This is a chi-squared test between the FRAIL categories for participants with or without delirium.|Chi-squared|||||||0.001
72483302|NCT02876835|144493449|SUPERIORITY||LS mean difference|-0.15||||0.6849|TWO_SIDED|95.0|-0.77|0.47|||MMRM||B pain,Week12:Model was fitted from Baseline up to Week52 and model adjusted Week12 data has been presented, with factors for treatment, time, current ESA use at randomization, region, BL value and BL value by time \& treatment by time interactions|||0.47|-0.77|0.6849
72483303|NCT02876835|144493449|SUPERIORITY||LS mean difference|-0.49||||0.9074|TWO_SIDED|95.0|-1.22|0.24|||MMRM||B pain,Week28:Model was fitted from Baseline up to Week52 and model adjusted Week28 data has been presented, with factors for treatment, time, current ESA use at randomization, region, BL value and BL value by time \& treatment by time interactions|||0.24|-1.22|0.9074
72483304|NCT02876835|144493449|SUPERIORITY||LS mean difference|-0.47||||0.8765|TWO_SIDED|95.0|-1.26|0.32|||MMRM||B pain,Week52:Model was fitted from Baseline up to Week52 and model adjusted Week52 data has been presented, with factors for treatment, time, current ESA use at randomization, region, BL value and BL value by time \& treatment by time interactions|||0.32|-1.26|0.8765
72483305|NCT02876835|144493449|SUPERIORITY||LS mean difference|-0.08||||0.6252|TWO_SIDED|95.0|-0.56|0.4|||MMRM||GH,Week8:Model was fitted from Baseline up to Week52 and model adjusted Week8 data has been presented, with factors for treatment, time, current ESA use at randomization, region, BL value and BL value by time \& treatment by time interactions|||0.40|-0.56|0.6252
72483306|NCT02876835|144493449|SUPERIORITY||LS mean difference|-0.2||||0.7852|TWO_SIDED|95.0|-0.68|0.29|||MMRM||GH,Week12:Model was fitted from Baseline up to Week52 and model adjusted Week12 data has been presented, with factors for treatment, time, current ESA use at randomization, region, BL value and BL value by time \& treatment by time interactions|||0.29|-0.68|0.7852
72483307|NCT02876835|144493449|SUPERIORITY||LS mean difference|0.1||||0.3614|TWO_SIDED|95.0|-0.46|0.66|||MMRM||GH,Week28:Model was fitted from Baseline up to Week52 and model adjusted Week28 data has been presented, with factors for treatment, time, current ESA use at randomization, region, BL value and BL value by time \& treatment by time interactions|||0.66|-0.46|0.3614
72483308|NCT02876835|144493449|SUPERIORITY||LS mean difference|-0.08||||0.5991|TWO_SIDED|95.0|-0.7|0.54|||MMRM||GH,Week52:Model was fitted from Baseline up to Week52 and model adjusted Week52 data has been presented, with factors for treatment, time, current ESA use at randomization, region, BL value and BL value by time \& treatment by time interactions|||0.54|-0.70|0.5991
72483309|NCT02876835|144493449|SUPERIORITY||LS mean difference|-0.31||||0.8526|TWO_SIDED|95.0|-0.88|0.27|||MMRM||MH,Week8:Model was fitted from Baseline up to Week52 and model adjusted Week8 data has been presented, with factors for treatment, time, current ESA use at randomization, region, BL value and BL value by time \& treatment by time interactions|||0.27|-0.88|0.8526
72483310|NCT02876835|144493449|SUPERIORITY||LS mean difference|0.02||||0.4673|TWO_SIDED|95.0|-0.56|0.61|||MMRM||MH,Week12:Model was fitted from Baseline up to Week52 and model adjusted Week12 data has been presented, with factors for treatment, time, current ESA use at randomization, region, BL value and BL value by time \& treatment by time interactions|||0.61|-0.56|0.4673
72483311|NCT02876835|144493449|SUPERIORITY||LS mean difference|-0.31||||0.8262|TWO_SIDED|95.0|-0.95|0.33|||MMRM||MH,Week28:Model was fitted from Baseline up to Week52 and model adjusted Week28 data has been presented, with factors for treatment, time, current ESA use at randomization, region, BL value and BL value by time \& treatment by time interactions|||0.33|-0.95|0.8262
72483312|NCT02876835|144493449|SUPERIORITY||LS mean difference|-0.25||||0.738|TWO_SIDED|95.0|-1.0|0.51|||MMRM||MH,Week52:Model was fitted from Baseline up to Week52 and model adjusted Week52 data has been presented, with factors for treatment, time, current ESA use at randomization, region, BL value and BL value by time \& treatment by time interactions|||0.51|-1.00|0.7380
72483313|NCT02876835|144493449|SUPERIORITY||LS mean difference|-0.09||||0.5997|TWO_SIDED|95.0|-0.8|0.62|||MMRM||RE,Week8:Model was fitted from Baseline up to Week52 and model adjusted Week8 data has been presented, with factors for treatment, time, current ESA use at randomization, region, BL value and BL value by time \& treatment by time interactions|||0.62|-0.80|0.5997
72483314|NCT02876835|144493449|SUPERIORITY||LS mean difference|-0.26||||0.7649|TWO_SIDED|95.0|-0.98|0.45|||MMRM||RE,Week12:Model was fitted from Baseline up to Week52 and model adjusted Week12 data has been presented, with factors for treatment, time, current ESA use at randomization, region, BL value and BL value by time \& treatment by time interactions|||0.45|-0.98|0.7649
72483315|NCT02876835|144493449|SUPERIORITY||LS mean difference|-0.37||||0.8175|TWO_SIDED|95.0|-1.18|0.43|||MMRM||RE,Week28:Model was fitted from Baseline up to Week52 and model adjusted Week28 data has been presented, with factors for treatment, time, current ESA use at randomization, region, BL value and BL value by time \& treatment by time interactions|||0.43|-1.18|0.8175
72483316|NCT02876835|144493449|SUPERIORITY||LS mean difference|-0.52||||0.8591|TWO_SIDED|95.0|-1.47|0.43|||MMRM||RE,Week52:Model was fitted from Baseline up to Week52 and model adjusted Week52 data has been presented, with factors for treatment, time, current ESA use at randomization, region, BL value and BL value by time \& treatment by time interactions|||0.43|-1.47|0.8591
72483317|NCT02876835|144493449|SUPERIORITY||LS mean difference|-0.5||||0.9588|TWO_SIDED|95.0|-1.06|0.06|||MMRM||RP,Week8:Model was fitted from Baseline up to Week52 and model adjusted Week8 data has been presented, with factors for treatment, time, current ESA use at randomization, region, BL value and BL value by time \& treatment by time interactions|||0.06|-1.06|0.9588
72511890|NCT02922634|144553821|SUPERIORITY|||||||0.002||||||This is a chi-squared test of the categories for levels of invasiveness for participants with or without delirium.|Chi-squared|||||||0.002
72511891|NCT01694420|144553866|SUPERIORITY_OR_OTHER||||||<|0.001||||||Study data compared to data as cited in PubMed ID: 21487250|Wilcoxon (Mann-Whitney)|||||||<0.001
72511892|NCT03987919|144553869|SUPERIORITY||LS Mean Difference|-0.51|||<|0.001|TWO_SIDED|95.0|-0.64|-0.38|||Mixed Models Analysis|||||-0.38|-0.64|<0.001
72511893|NCT03987919|144553869|SUPERIORITY||LS Mean Difference|-0.6|||<|0.001|TWO_SIDED|95.0|-0.73|-0.47|||Mixed Models Analysis|||||-0.47|-0.73|<0.001
72511894|NCT03987919|144553870|SUPERIORITY||LS Mean Difference|-0.23|||<|0.001|TWO_SIDED|95.0|-0.36|-0.1|||Mixed Models Analysis|||||-0.10|-0.36|<0.001
72511895|NCT03987919|144553871|SUPERIORITY||LS Mean Difference|-1.7|||<|0.001|TWO_SIDED|95.0|-2.6|-0.7|||Mixed Models Analysis|||||-0.7|-2.6|<0.001
72511896|NCT03987919|144553871|SUPERIORITY||LS Mean Difference|-4.1|||<|0.001|TWO_SIDED|95.0|-5.0|-3.2|||Mixed Models Analysis|||||-3.2|-5.0|<0.001
72511897|NCT03987919|144553871|SUPERIORITY||LS Mean Difference|-6.2|||<|0.001|TWO_SIDED|95.0|-7.1|-5.3|||Mixed Models Analysis|||||-5.3|-7.1|<0.001
72511898|NCT03987919|144553872|SUPERIORITY||Odds Ratio (OR)|1.54||||0.023|TWO_SIDED|95.0|1.06|2.23|||Regression, Logistic|||||2.23|1.06|0.023
72483318|NCT02876835|144493449|SUPERIORITY||LS mean difference|-0.33||||0.8761|TWO_SIDED|95.0|-0.9|0.23|||MMRM||RP,Week12:Model was fitted from Baseline up to Week52 and model adjusted Week12 data has been presented, with factors for treatment, time, current ESA use at randomization, region, BL value and BL value by time \& treatment by time interactions|||0.23|-0.90|0.8761
72483319|NCT02876835|144493449|SUPERIORITY||LS mean difference|0.06||||0.4293|TWO_SIDED|95.0|-0.58|0.7|||MMRM||RP,Week28:Model was fitted from Baseline up to Week52 and model adjusted Week28 data has been presented, with factors for treatment, time, current ESA use at randomization, region, BL value and BL value by time \& treatment by time interactions|||0.70|-0.58|0.4293
72511899|NCT03987919|144553872|SUPERIORITY||Odds Ratio (OR)|2.14|||<|0.001|TWO_SIDED|95.0|1.44|3.17|||Regression, Logistic|||||3.17|1.44|<0.001
72511900|NCT03987919|144553872|SUPERIORITY||Odds Ratio (OR)|3.03|||<|0.001|TWO_SIDED|95.0|1.97|4.66|||Regression, Logistic|||||4.66|1.97|<0.001
72567219|NCT03265288|144665364|SUPERIORITY||Risk Ratio (RR)|1.11||||0.7473|TWO_SIDED|95.0|0.6|2.04||alpha is set to 0.05|Poisson regression||Odds ratio \< 1 means lower odds in terms of days of antibiotics with LAU-7b, odds ratio close to 1 means similar odds in terms of days of antibiotics with LAU-7b or placebo, odds ratio \> 1 means higher odds in terms of days of antibiotics with LAU-7b|Number of days of intravenous antibiotics required for a pulmonary exacerbation, excludes Cycle 1 pulmonary exacerbations, Intent to treat population (ITT), null hypothesis is no treatment effect||2.04|0.60|0.7473
72567220|NCT03265288|144665365|SUPERIORITY||Least Squares Means difference|-2.89||||0.0822|TWO_SIDED|95.0|-6.154|0.374||alpha is set to 0.05|Mixed Model for Repeated Measures||A negative difference favours LAU-7b, a positive difference favours placebo|C-Reactive Protein (CRP), Intent-to-Treat population (ITT), null hypothesis is no treatment effect||0.374|-6.154|0.0822
72567221|NCT03265288|144665365|SUPERIORITY||Least Squares Means difference|-576.0||||0.0603|TWO_SIDED|95.0|-1177.0|25.4||alpha is set to 0.05|Mixed Model for Repeated Measures||A negative difference favours LAU-7b, a positive difference favours placebo|Calprotectin, Intent-to-Treat population (ITT), null hypothesis is no treatment effect||25.4|-1177|0.0603
72483320|NCT02876835|144493449|SUPERIORITY||LS mean difference|-0.19||||0.6983|TWO_SIDED|95.0|-0.92|0.53|||MMRM||RP,Week52:Model was fitted from Baseline up to Week52 and model adjusted Week52 data has been presented, with factors for treatment, time, current ESA use at randomization, region, BL value and BL value by time \& treatment by time interactions|||0.53|-0.92|0.6983
72483321|NCT02876835|144493449|SUPERIORITY||LS mean difference|-0.62||||0.9743|TWO_SIDED|95.0|-1.25|0.0|||MMRM||SF,Week8:Model was fitted from Baseline up to Week52 and model adjusted Week8 data has been presented, with factors for treatment, time, current ESA use at randomization, region, BL value and BL value by time \& treatment by time interactions|||0.00|-1.25|0.9743
72483322|NCT02876835|144493449|SUPERIORITY||LS mean difference|-0.32||||0.8405|TWO_SIDED|95.0|-0.94|0.31|||MMRM||SF,Week12:Model was fitted from Baseline up to Week52 and model adjusted Week12 data has been presented, with factors for treatment, time,current ESA use at randomization, region, BL value and BL value by time \& treatment by time interactions|||0.31|-0.94|0.8405
72483323|NCT02876835|144493449|SUPERIORITY||LS mean difference|-0.13||||0.6459|TWO_SIDED|95.0|-0.82|0.56|||MMRM||SF,Week28:Model was fitted from Baseline up to Week52 and model adjusted Week28 data has been presented, with factors for treatment, time, current ESA use at randomization, region, BL value and BL value by time \& treatment by time interactions|||0.56|-0.82|0.6459
72483324|NCT02876835|144493449|SUPERIORITY||LS mean difference|-0.38||||0.8272|TWO_SIDED|95.0|-1.17|0.41|||MMRM||SF,Week52:Model was fitted from Baseline up to Week52 and model adjusted Week52 data has been presented, with factors for treatment, time, current ESA use at randomization, region, BL value and BL value by time \& treatment by time interactions|||0.41|-1.17|0.8272
72483325|NCT02876835|144493450|SUPERIORITY||LS mean difference|-0.56||||0.9786|TWO_SIDED|95.0|-1.09|-0.02|||MMRM||Week 8: Model was fitted from Baseline up to Week 52 and model adjusted Week 8 data has been presented,with factors for treatment, time,current ESA use at randomization, region, BL value and BL value by time \& treatment by time interactions.|||-0.02|-1.09|0.9786
72483326|NCT02876835|144493450|SUPERIORITY||LS mean difference|-0.12||||0.6642|TWO_SIDED|95.0|-0.68|0.44|||MMRM||Week 12: Model was fitted from Baseline up to Week 52 and model adjusted Week 12 data has been presented,with factors for treatment, time,current ESA use at randomization, region, BL value and BL value by time \& treatment by time interactions.|||0.44|-0.68|0.6642
72511901|NCT03987919|144553873|SUPERIORITY||LS Mean Difference|-7.3||||0.001|TWO_SIDED|95.0|-11.7|-3.0|||Mixed Models Analysis|||||-3.0|-11.7|0.001
72567222|NCT03265288|144665365|SUPERIORITY||Least Square Means difference|-3.853||||0.0287|TWO_SIDED|95.0|-7.297|-0.408||alpha is set to 0.05|Mixed Model for Repeated Measures||A negative difference favours LAU-7b, a positive difference favours placebo|C-Reactive Protein (CRP), Per-Protocol population (PP), null hypothesis is no treatment effect||-0.408|-7.297|0.0287
72567223|NCT03265288|144665365|SUPERIORITY||Least Square Means difference|-620.0||||0.0459|TWO_SIDED|95.0|-1228.0|12.0||alpha is set to 0.05|Mixed Model for Repeated Measures||A negative difference favours LAU-7b, a positive difference favours placebo|Calprotectin, Per-Protocol population (PP), null hypothesis is no treatment effect||12|-1228|0.0459
72567224|NCT03265288|144665366|SUPERIORITY||Least Squares Means difference|-0.39||||0.1006|TWO_SIDED|95.0|-0.86|0.08||alpha is set to 0.05|Mixed Model for Repeated Measures|||Body weight, Intent to treat population (ITT), null hypothesis is no treatment effect||0.08|-0.86|0.1006
72483327|NCT02876835|144493450|SUPERIORITY||LS mean difference|-0.1||||0.6261|TWO_SIDED|95.0|-0.72|0.52|||MMRM||Week 28: Model was fitted from Baseline up to Week 52 and model adjusted Week 28 data has been presented,with factors for treatment, time,current ESA use at randomization, region, BL value and BL value by time \& treatment by time interactions.|||0.52|-0.72|0.6261
72511902|NCT03987919|144553873|SUPERIORITY||LS Mean Difference|-13.0|||<|0.001|TWO_SIDED|95.0|-17.4|-8.6|||Mixed Models Analysis|||||-8.6|-17.4|<0.001
72511903|NCT03987919|144553873|SUPERIORITY||LS Mean Difference|-14.7|||<|0.001|TWO_SIDED|95.0|-19.1|-10.3|||Mixed Models Analysis|||||-10.3|-19.1|<0.001
72511904|NCT03987919|144553875|SUPERIORITY||Odds Ratio (OR)|1.58||||0.001|TWO_SIDED|95.0|1.2|2.08|||Regression, Logistic|||||2.08|1.20|0.001
72511905|NCT03987919|144553875|SUPERIORITY||Odds Ratio (OR)|3.49|||<|0.001|TWO_SIDED|95.0|2.57|4.75|||Regression, Logistic|||||4.75|2.57|<0.001
72483328|NCT02876835|144493450|SUPERIORITY||LS mean difference|-0.49||||0.9161|TWO_SIDED|95.0|-1.19|0.21|||MMRM||Week 52: Model was fitted from Baseline up to Week 52 and model adjusted Week 52 data has been presented,with factors for treatment, time,current ESA use at randomization, region, BL value and BL value by time \& treatment by time interactions.|||0.21|-1.19|0.9161
72483329|NCT02876835|144493451|SUPERIORITY||LS mean difference|-0.32||||0.8703|TWO_SIDED|95.0|-0.88|0.24|||MMRM||Week 8: Model was fitted from Baseline up to Week 52 and model adjusted Week 8 data has been presented,with factors for treatment, time,current ESA use at randomization, region, BL value and BL value by time \& treatment by time interactions.|||0.24|-0.88|0.8703
72483330|NCT02876835|144493451|SUPERIORITY||LS mean difference|0.13||||0.3167|TWO_SIDED|95.0|-0.41|0.67|||MMRM||Week 12: Model was fitted from Baseline up to Week 52 and model adjusted Week 12 data has been presented,with factors for treatment, time,current ESA use at randomization, region, BL value and BL value by time \& treatment by time interactions.|||0.67|-0.41|0.3167
72483331|NCT02876835|144493451|SUPERIORITY||LS mean difference|0.15||||0.3155|TWO_SIDED|95.0|-0.47|0.78|||MMRM||Week 28: Model was fitted from Baseline up to Week 52 and model adjusted Week 28 data has been presented,with factors for treatment, time,current ESA use at randomization, region, BL value and BL value by time \& treatment by time interactions.|||0.78|-0.47|0.3155
72483332|NCT02876835|144493451|SUPERIORITY||LS mean difference|-0.32||||0.8069|TWO_SIDED|95.0|-1.06|0.41|||MMRM||Week 52: Model was fitted from Baseline up to Week 52 and model adjusted Week 52 data has been presented,with factors for treatment, time,current ESA use at randomization, region, BL value and BL value by time \& treatment by time interactions.|||0.41|-1.06|0.8069
72483333|NCT02876835|144493452|SUPERIORITY||LS mean difference|-0.0234||||0.9724|TWO_SIDED|95.0|-0.0474|0.0005|||MMRM||MMRM model was fitted from Baseline up to Week 52 with factors for treatment, time, current ESA use, region, Baseline value and Baseline value by time and treatment by time interactions.|||0.0005|-0.0474|0.9724
72483334|NCT02876835|144493453|SUPERIORITY||LS mean difference|0.7||||0.2687|TWO_SIDED|95.0|-1.5|2.9|||MMRM||MMRM model was fitted from Baseline up to Week 52 with factors for treatment, time, current ESA use, region, Baseline value and Baseline value by time and treatment by time interactions.|||2.9|-1.5|0.2687
72483335|NCT02876835|144493454|SUPERIORITY||LS mean difference|-1.22||||0.978|TWO_SIDED|95.0|-2.4|-0.03|||MMRM||Tired/LE/Weak domain,Week8:Model was fitted from Baseline up to Week52 and model adjusted Week8 data has been presented, with factors for treatment, time, current ESA use, region, BL value and BL value by time and treatment by time interactions.|||-0.03|-2.40|0.9780
72483336|NCT02876835|144493454|SUPERIORITY||LS mean difference|-0.97||||0.943|TWO_SIDED|95.0|-2.18|0.23|||MMRM||Tired/LE/Weak domain,Week12:Model was fitted from Baseline up to Week52 and model adjusted Week12 data has been presented, with factors for treatment, time, current ESA use, region, BL value and BL value by time and treatment by time interactions.|||0.23|-2.18|0.9430
72483337|NCT02876835|144493454|SUPERIORITY||LS mean difference|-0.6||||0.8042|TWO_SIDED|95.0|-1.98|0.77|||MMRM||Tired/LE/Weak domain,Week28:Model was fitted from Baseline up to Week52 and model adjusted Week28 data has been presented, with factors for treatment, time, current ESA use, region, BL value and BL value by time and treatment by time interactions.|||0.77|-1.98|0.8042
72483338|NCT02876835|144493454|SUPERIORITY||LS mean difference|-1.57||||0.977|TWO_SIDED|95.0|-3.11|-0.03|||MMRM||Tired/LE/Weak domain,Week52:Model was fitted from Baseline up to Week52 and model adjusted Week52 data has been presented, with factors for treatment, time, current ESA use, region, BL value and BL value by time and treatment by time interactions.|||-0.03|-3.11|0.9770
72483339|NCT02876835|144493454|SUPERIORITY||LS mean difference|-1.2||||0.9905|TWO_SIDED|95.0|-2.2|-0.2|||MMRM||CP/SOB,Week8:Model was fitted from Baseline up to Week52 and model adjusted Week8 data has been presented, with factors for treatment, time, current ESA use, region, BL value and BL value by time and treatment by time interactions.|||-0.20|-2.20|0.9905
72511906|NCT03987919|144553875|SUPERIORITY||Odds Ratio (OR)|4.6|||<|0.001|TWO_SIDED|95.0|3.32|6.38|||Regression, Logistic|||||6.38|3.32|<0.001
72511907|NCT03987919|144553876|SUPERIORITY||LS Mean Difference|-0.24||||0.084|TWO_SIDED|95.0|-0.5|0.03|||ANCOVA|||Hyperglycemia||0.03|-0.50|0.084
72483340|NCT02876835|144493454|SUPERIORITY||LS mean difference|-0.65||||0.8939|TWO_SIDED|95.0|-1.67|0.37|||LS mean difference||CP/SOB,Week12:Model was fitted from Baseline up to Week52 and model adjusted Week12 data has been presented, with factors for treatment, time, current ESA use, region, BL value and BL value by time and treatment by time interactions.|||0.37|-1.67|0.8939
72483341|NCT02876835|144493454|SUPERIORITY||LS mean difference|-0.52||||0.807|TWO_SIDED|95.0|-1.7|0.66|||MMRM||CP/SOB,Week28:Model was fitted from Baseline up to Week52 and model adjusted Week28 data has been presented, with factors for treatment, time, current ESA use, region, BL value and BL value by time and treatment by time interactions.|||0.66|-1.70|0.8070
72567225|NCT03265288|144665367|SUPERIORITY||Least Squares Means difference|-0.137||||0.1246|TWO_SIDED|95.0|-0.312|0.038||alpha is set to 0.05|Mixed Model for Repeated Measures|||Body mass index, intent to treat population (ITT), null hypothesis is no treatment effect||0.038|-0.312|0.1246
72483342|NCT02876835|144493454|SUPERIORITY||LS mean difference|-1.18||||0.9615|TWO_SIDED|95.0|-2.49|0.13|||MMRM||CP/SOB,Week52:Model was fitted from Baseline up to Week52 and model adjusted Week52 data has been presented, with factors for treatment, time, current ESA use, region, BL value and BL value by time and treatment by time interactions.|||0.13|-2.49|0.9615
72483343|NCT02876835|144493454|SUPERIORITY||LS mean difference|-0.76||||0.9015|TWO_SIDED|95.0|-1.91|0.39|||MMRM||Cog domain,Week8:Model was fitted from Baseline up to Week52 and model adjusted Week8 data has been presented, with factors for treatment, time, current ESA use, region, BL value and BL value by time and treatment by time interactions.|||0.39|-1.91|0.9015
72483344|NCT02876835|144493454|SUPERIORITY||LS mean difference|-1.18||||0.9781|TWO_SIDED|95.0|-2.32|-0.03|||MMRM||Cog domain,Week12:Model was fitted from Baseline up to Week52 and model adjusted Week12 data has been presented, with factors for treatment, time, current ESA use, region, BL value and BL value by time and treatment by time interactions.|||-0.03|-2.32|0.9781
72511908|NCT03987919|144553876|SUPERIORITY||LS Mean Difference|-0.27||||0.05|TWO_SIDED|95.0|-0.54|0.0|||ANCOVA|||Hyperglycemia||0.00|-0.54|0.050
72511909|NCT03987919|144553876|SUPERIORITY||LS Mean Difference|-0.39||||0.005|TWO_SIDED|95.0|-0.66|-0.12|||ANCOVA|||Hyperglycemia||-0.12|-0.66|0.005
72511910|NCT03987919|144553876|SUPERIORITY||LS Mean Difference|-0.06||||0.688|TWO_SIDED|95.0|-0.33|0.22|||ANCOVA|||Hypoglycemia||0.22|-0.33|0.688
72511911|NCT03987919|144553876|SUPERIORITY||LS Mean Difference|-0.02||||0.909|TWO_SIDED|95.0|-0.29|0.26|||ANCOVA|||Hypoglycemia||0.26|-0.29|0.909
72511912|NCT03987919|144553876|SUPERIORITY||LS Mean Difference|-0.13||||0.358|TWO_SIDED|95.0|-0.4|0.15|||ANCOVA|||Hypoglycemia||0.15|-0.40|0.358
72483345|NCT02876835|144493454|SUPERIORITY||LS mean difference|-0.77||||0.8778|TWO_SIDED|95.0|-2.07|0.53|||MMRM||Cog domain,Week28:Model was fitted from Baseline up to Week52 and model adjusted Week28 data has been presented, with factors for treatment, time, current ESA use, region, BL value and BL value by time and treatment by time interactions.|||0.53|-2.07|0.8778
72483346|NCT02876835|144493454|SUPERIORITY||LS mean difference|-1.65||||0.9864|TWO_SIDED|95.0|-3.11|-0.19|||MMRM||Cog domain,Week52:Model was fitted from Baseline up to Week52 and model adjusted Week52 data has been presented, with factors for treatment, time, current ESA use, region, BL value and BL value by time and treatment by time interactions.|||-0.19|-3.11|0.9864
72483347|NCT02876835|144493454|SUPERIORITY||LS mean difference|-1.1||||0.9725|TWO_SIDED|95.0|-2.3|0.0|||MMRM||SOB, no activity,Week8:Model was fitted from Baseline up to Week52 and model adjusted Week8 data has been presented, with factors for treatment, time, current ESA use, region, BL value and BL value by time and treatment by time interactions.|||0.0|-2.3|0.9725
72483348|NCT02876835|144493454|SUPERIORITY||LS mean difference|-0.3||||0.7188|TWO_SIDED|95.0|-1.5|0.8|||MMRM||SOB, no activity,Week12:Model was fitted from Baseline up to Week52 and model adjusted Week12 data has been presented, with factors for treatment, time, current ESA use, region, BL value and BL value by time and treatment by time interactions.|||0.8|-1.5|0.7188
72483349|NCT02876835|144493454|SUPERIORITY||LS mean difference|-0.9||||0.8903|TWO_SIDED|95.0|-2.3|0.5|||MMRM||SOB, no activity,Week28:Model was fitted from Baseline up to Week52 and model adjusted Week28 data has been presented, with factors for treatment, time, current ESA use, region, BL value and BL value by time and treatment by time interactions.|||0.5|-2.3|0.8903
72483350|NCT02876835|144493454|SUPERIORITY||LS mean difference|0.0||||0.5011|TWO_SIDED|95.0|-1.6|1.6|||MMRM||SOB, no activity,Week52:Model was fitted from Baseline up to Week52 and model adjusted Week52 data has been presented, with factors for treatment, time, current ESA use, region, BL value and BL value by time and treatment by time interactions.|||1.6|-1.6|0.5011
72483351|NCT02876835|144493454|SUPERIORITY||LS mean difference|-1.1||||0.9716|TWO_SIDED|95.0|-2.2|0.0|||MMRM||S-SB,Resting, Week8:Model was fitted from Baseline up to Week52 and model adjusted Week8 data has been presented, with factors for treatment, time, current ESA use, region, BL value and BL value by time and treatment by time interactions.|||0.0|-2.2|0.9716
72483352|NCT02876835|144493454|SUPERIORITY||LS mean difference|-0.3||||0.6908|TWO_SIDED|95.0|-1.4|0.9|||MMRM||S-SB,Resting, Week12:Model was fitted from Baseline up to Week52 and model adjusted Week12 data has been presented, with factors for treatment, time, current ESA use, region, BL value and BL value by time and treatment by time interactions.|||0.9|-1.4|0.6908
72483353|NCT02876835|144493454|SUPERIORITY||LS mean difference|-0.5||||0.7462|TWO_SIDED|95.0|-1.8|0.9|||MMRM||S-SB,Resting, Week28:Model was fitted from Baseline up to Week52 and model adjusted Week28 data has been presented, with factors for treatment, time, current ESA use, region, BL value and BL value by time and treatment by time interactions.|||0.9|-1.8|0.7462
72483354|NCT02876835|144493454|SUPERIORITY||LS mean difference|-1.5||||0.977|TWO_SIDED|95.0|-2.9|0.0|||MMRM||S-SB,Resting, Week52:Model was fitted from Baseline up to Week52 and model adjusted Week52 data has been presented, with factors for treatment, time, current ESA use, region, BL value and BL value by time and treatment by time interactions.|||0.0|-2.9|0.9770
72511913|NCT03987919|144553876|SUPERIORITY||LS Mean Difference|-0.1||||0.701|TWO_SIDED|95.0|-0.62|0.41|||ANCOVA|||Total Score||0.41|-0.62|0.701
72511914|NCT03987919|144553876|SUPERIORITY||LS Mean Difference|-0.25||||0.341|TWO_SIDED|95.0|-0.78|0.27|||ANCOVA|||Total Score||0.27|-0.78|0.341
72511915|NCT03987919|144553876|SUPERIORITY||LS Mean Difference|0.26||||0.321|TWO_SIDED|95.0|-0.26|0.79|||ANCOVA|||Total Score||0.79|-0.26|0.321
72511916|NCT03987919|144553878|SUPERIORITY||Odds Ratio (OR)|1.86|||<|0.001|TWO_SIDED|95.0|1.35|2.57|||Regression, Logistic|||||2.57|1.35|<0.001
72511917|NCT03987919|144553878|SUPERIORITY||Odds Ratio (OR)|3.94|||<|0.001|TWO_SIDED|95.0|2.88|5.39|||Regression, Logistic|||||5.39|2.88|<0.001
72511918|NCT03987919|144553878|SUPERIORITY||Odds Ratio (OR)|5.1|||<|0.001|TWO_SIDED|95.0|3.73|6.97|||Regression, Logistic|||||6.97|3.73|<0.001
72511919|NCT01194804|144553879|OTHER||||||<|0.001|||||||Sign test|||||||<0.001
72511920|NCT03621943|144553884|SUPERIORITY||Mean Difference (Final Values)|-0.49||||0.87|TWO_SIDED|95.0|-6.36|5.37|||hierarchical generalized linear mixed mo|hierarchical generalized linear mixed models||Total score on the Ages and Stages Questionnaire, 3rd ed.||5.37|-6.36|0.87
72483355|NCT02876835|144493454|SUPERIORITY||LS mean difference|-1.4||||0.9471|TWO_SIDED|95.0|-3.2|0.3|||MMRM||Diff std for LT, Week8:Model was fitted from Baseline up to Week52 and model adjusted Week8 data has been presented, with factors for treatment, time, current ESA use, region, BL value and BL value by time and treatment by time interactions.|||0.3|-3.2|0.9471
72483356|NCT02876835|144493454|SUPERIORITY||LS mean difference|-0.9||||0.833|TWO_SIDED|95.0|-2.6|0.9|||MMRM||Diff std for LT, Week12:Model was fitted from Baseline up to Week52 and model adjusted Week12 data has been presented, with factors for treatment, time, current ESA use, region, BL value and BL value by time and treatment by time interactions.|||0.9|-2.6|0.8330
72511921|NCT00948818|144553909|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.6||||0.0004|TWO_SIDED|95.0|1.51|4.47||The p-value is still less than 0.05 after adjusting multiplicity using a serial gatekeeping multiple comparison procedure.|Cochran-Mantel-Haenszel|||"Null Hypothesis: There is no difference between the 290 μg dose and placebo groups in the proportion of 9/12 Week APC 3 + 1 Responders.~The power, adjusted for multiplicity, was expected to be 93% based on NCT00460811 (MCP-103-202) study data."||4.47|1.51|0.0004
72511922|NCT00948818|144553911|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.65|||<|0.0001|TWO_SIDED|95.0|2.26|5.88||The p-value is still less than 0.05 after adjusting multiplicity using a serial gatekeeping multiple comparison procedure.|Cochran-Mantel-Haenszel|||"Null Hypothesis: There is no difference between the 290 μg dose and placebo groups in the proportion of 9/12 Week CSBM 3 + 1 Responders.~The power, adjusted for multiplicity, was expected to be 93% based on NCT00460811 (MCP-103-202) study data."||5.88|2.26|<0.0001
72567226|NCT03265288|144665368|SUPERIORITY|||||||0.764||||||alpha is set to 0.05|ANOVA|||Intent to treat population (ITT), null hypothesis is no treatment effect||||0.7640
72567227|NCT03265288|144665369|SUPERIORITY||Least Squares Means difference|-2.758||||0.2996|TWO_SIDED|95.0|-7.998|2.482||alpha is set to 0.05|Mixed Model for Repeated Measures|||CFQ-R Respiratory subscore, intent to treat population (ITT), null hypothesis is no treatment effect||2.482|-7.998|0.2996
72624053|NCT05852470|144778450|NON_INFERIORITY|Non-inferiority margin = 0.1 logMAR|Difference in Means|0.034|STANDARD_ERROR_OF_MEAN|0.0167|||TWO_SIDED|95.0|0.001|0.067||Since a non-inferiority hypothesis is being tested, a p-value is not applicable. Confidence limit is being reported and compared to the non-inferiority margin.|||Parameter Dispersion Type is Standard Error of the Difference in Means. Difference = Vivity/Vivity Toric Extended Vision IOL minus Clareon/Clareon Toric Monofocal IOL|||0.067|0.001|
72483357|NCT02876835|144493454|SUPERIORITY||LS mean difference|-1.2||||0.8918|TWO_SIDED|95.0|-3.2|0.7|||MMRM||Diff std for LT, Week28:Model was fitted from Baseline up to Week52 and model adjusted Week28 data has been presented, with factors for treatment, time, current ESA use, region, BL value and BL value by time and treatment by time interactions.|||0.7|-3.2|0.8918
72483358|NCT02876835|144493454|SUPERIORITY||LS mean difference|-3.2||||0.9986|TWO_SIDED|95.0|-5.4|-1.1|||MMRM||Diff std for LT, Week52:Model was fitted from Baseline up to Week52 and model adjusted Week52 data has been presented, with factors for treatment, time, current ESA use, region, BL value and BL value by time and treatment by time interactions.|||-1.1|-5.4|0.9986
72483359|NCT02876835|144493454|SUPERIORITY||LS mean difference|0.4||||0.3035|TWO_SIDED|95.0|-1.2|2.1|||MMRM||Diff sleep, Week8:Model was fitted from Baseline up to Week52 and model adjusted Week8 data has been presented, with factors for treatment, time, current ESA use, region, BL value and BL value by time and treatment by time interactions.|||2.1|-1.2|0.3035
72483360|NCT02876835|144493454|SUPERIORITY||LS mean difference|-1.4||||0.9563|TWO_SIDED|95.0|-3.1|0.2|||MMRM||Diff sleep, Week12:Model was fitted from Baseline up to Week52 and model adjusted Week12 data has been presented, with factors for treatment, time, current ESA use, region, BL value and BL value by time and treatment by time interactions.|||0.2|-3.1|0.9563
72483361|NCT02876835|144493454|SUPERIORITY||LS mean difference|-0.4||||0.6548|TWO_SIDED|95.0|-2.3|1.5|||MMRM||Diff sleep, Week28:Model was fitted from Baseline up to Week52 and model adjusted Week28 data has been presented, with factors for treatment, time, current ESA use, region, BL value and BL value by time and treatment by time interactions.|||1.5|-2.3|0.6548
72483362|NCT02876835|144493454|SUPERIORITY||LS mean difference|-2.4||||0.9832|TWO_SIDED|95.0|-4.5|-0.2|||MMRM||Diff sleep, Week52:Model was fitted from Baseline up to Week52 and model adjusted Week52 data has been presented, with factors for treatment, time, current ESA use, region, BL value and BL value by time and treatment by time interactions.|||-0.2|-4.5|0.9832
72483363|NCT02876835|144493455|SUPERIORITY||LS mean difference|0.02||||0.6917|TWO_SIDED|95.0|-0.05|0.08|||MMRM||Week 8: Model was fitted from Baseline up to Week52 and model adjusted Week 8 data has been presented, with factors for treatment, time, current ESA use, region, Baseline value and Baseline value by time and treatment by time interactions.|||0.08|-0.05|0.6917
72483364|NCT02876835|144493455|SUPERIORITY||LS mean difference|0.05||||0.951|TWO_SIDED|95.0|-0.01|0.11|||MMRM||Week 12: Model was fitted from Baseline up to Week52 and model adjusted Week 12 data has been presented, with factors for treatment, time, current ESA use, region, Baseline value and Baseline value by time and treatment by time interactions.|||0.11|-0.01|0.9510
72483365|NCT02876835|144493455|SUPERIORITY||LS mean difference|-0.04||||0.1136|TWO_SIDED|95.0|-0.11|0.03|||MMRM||Week 28: Model was fitted from Baseline up to Week52 and model adjusted Week 28 data has been presented, with factors for treatment, time, current ESA use, region, Baseline value and Baseline value by time and treatment by time interactions.|||0.03|-0.11|0.1136
72483366|NCT02876835|144493455|SUPERIORITY||LS mean difference|0.05||||0.8859|TWO_SIDED|95.0|-0.03|0.13|||MMRM||Week 52: Model was fitted from Baseline up to Week52 and model adjusted Week 52 data has been presented, with factors for treatment, time, current ESA use, region, Baseline value and Baseline value by time and treatment by time interactions.|||0.13|-0.03|0.8859
72483367|NCT02876835|144493456|SUPERIORITY||LS mean difference|-0.2||||0.7716|TWO_SIDED|95.0|-0.74|0.33|||MMRM||MMRM model was fitted from Baseline up to Week 52 with factors for treatment, time, current ESA use at randomization, region, Baseline value and Baseline value by time and treatment by time interactions.|||0.33|-0.74|0.7716
72483368|NCT02979925|144493464|SUPERIORITY|||||||0.246|||||||Mixed Models Analysis|||||||0.246
72483369|NCT02979925|144493465|SUPERIORITY|||||||0.651|||||||Mixed Models Analysis|||||||0.651
72483370|NCT02979925|144493466|SUPERIORITY|||||||0.902|||||||Mixed Models Analysis|||||||0.902
72483371|NCT03829319|144493487|OTHER||Hazard Ratio (HR)|0.88||||0.07976|TWO_SIDED|95.0|0.74|1.05|||Stratified Log Rank|Two-sided p-value based on log-rank test stratified by ECOG performance status, geographic region of the enrolling site, and baseline PD-L1 status.||Comparison based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG performance status (0 versus 1), geographic region of the enrolling site (East Asia versus non-East Asia), and Baseline PD-L1 Status (\<50% versus \>=50%).||1.05|0.74|0.07976
72483372|NCT03829319|144493488|OTHER||Hazard Ratio (HR)|1.05||||0.70818|TWO_SIDED|95.0|0.88|1.26|||Stratified Log Rank|Two-sided p-value based on log-rank test stratified by ECOG performance status, geographic region of the enrolling site, and baseline PD-L1 status.||Comparison based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG performance status (0 versus 1), geographic region of the enrolling site (East Asia versus non-East Asia), and Baseline PD-L1 Status (\<50% versus \>=50%).||1.26|0.88|0.70818
72483373|NCT03829319|144493489|OTHER||Percent Difference|6.3||||0.08643|TWO_SIDED|95.0|-2.8|15.4|||Stratified Miettinen & Nurminen|One-sided p-value for testing. H0: difference in percent = 0 versus H1: difference in percent \> 0.||Comparison based on Miettinen \& Nurminen method stratified by ECOG performance status (0 versus 1), geographic region of the enrolling site (East Asia versus non-East Asia), and Baseline PD-L1 Status (\<50% versus \>=50% ).||15.4|-2.8|0.08643
72567228|NCT03197558|144665374|SUPERIORITY|Upper confidence limit of mean VAS score hypothesized to be less than (superior) to a performance goal of 45 mm.|Bootstrap method|14.35|||||ONE_SIDED|97.5||14.35||||||Mean VAS score compared to performance goal using a bootstrap method test at 2.5% significance.||14.35||
72483374|NCT03829319|144493493|OTHER||Difference in Least Square Means|-1.01||||0.4805|TWO_SIDED|95.0|-3.83|1.8|||t-test, 2 sided|||Comparision based on a cLDA model with the PRO scores as the response variable with covariates for treatment by time interaction, stratification factors (baseline ECOG performance status (0 versus 1), geographic region of the enrolling site (East Asia versus non-East Asia), and baseline PD-L1 Status ( \<50% versus ≥50%)) as covariates.||1.80|-3.83|0.4805
72483375|NCT03829319|144493494|OTHER||Difference in Least Square Means|-0.29||||0.8747|TWO_SIDED|95.0|-3.95|3.36|||t-test, 2 sided|||Comparision based on a cLDA model with the PRO scores as the response variable with covariates for treatment by time interaction, stratification factors (baseline ECOG performance status (0 versus 1), geographic region of the enrolling site (East Asia versus non-East Asia), and baseline PD-L1 Status ( \<50% versus ≥50%)) as covariates.||3.36|-3.95|0.8747
72483376|NCT03829319|144493495|OTHER||Difference in Least Square Means|-0.91||||0.5941|TWO_SIDED|95.0|-4.24|2.43|||t-test, 2 sided|||Comparision based on a cLDA model with the PRO scores as the response variable with covariates for treatment by time interaction, stratification factors (baseline ECOG performance status (0 versus 1), geographic region of the enrolling site (East Asia versus non-East Asia), and baseline PD-L1 Status (\<50% versus ≥50%)) as covariates.||2.43|-4.24|0.5941
72483377|NCT03829319|144493496|OTHER||covariate|-2.16||||0.3115|TWO_SIDED|95.0|-6.36|2.03|||t-test, 2 sided|||Comparision based on a cLDA model with the PRO scores as the response variable with covariates for treatment by time interaction, stratification factors (baseline ECOG performance status (0 versus 1), geographic region of the enrolling site (East Asia versus non-East Asia), and baseline PD-L1 Status ( \<50% versus ≥50%)) as covariates.||2.03|-6.36|0.3115
72483378|NCT03829319|144493497|OTHER||covariate|-0.37||||0.8134|TWO_SIDED|95.0|-3.47|2.72|||t-test, 2 sided|||Comparision based on a cLDA model with the PRO scores as the response variable with covariates for treatment by time interaction, stratification factors (baseline ECOG performance status (0 versus 1), geographic region of the enrolling site (East Asia versus non-East Asia), and baseline PD-L1 Status ( \<50% versus ≥50%)) as covariates.||2.72|-3.47|0.8134
72483379|NCT03829319|144493498|OTHER||Hazard Ratio (HR)|1.16||||0.2133|TWO_SIDED|95.0|0.92|1.47|||Stratified Log Rank|Two-sided p-value based on log-rank test stratified by ECOG performance status, geographic region of the enrolling site, and baseline PD-L1 status.||Comparison based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG performance status (0 versus 1), geographic region of the enrolling site (East Asia versus non-East Asia), and Baseline PD-L1 Status (\<50% versus \>=50%).||1.47|0.92|0.2133
72483380|NCT03829319|144493499|OTHER||Hazard Ratio (HR)|1.41||||0.0377|TWO_SIDED|95.0|1.02|1.94|||Stratified Log Rank|Two-sided p-value based on log-rank test stratified by ECOG performance status, geographic region of the enrolling site, and baseline PD-L1 status.||Comparison based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG performance status (0 versus 1), geographic region of the enrolling site (East Asia versus non-East Asia), and Baseline PD-L1 Status (\<50% versus \>=50%).||1.94|1.02|0.0377
72483381|NCT03829319|144493500|OTHER||Hazard Ratio (HR)|0.87||||0.4084|TWO_SIDED|95.0|0.62|1.21|||Stratified Log Rank|Two-sided p-value based on log-rank test stratified by ECOG performance status, geographic region of the enrolling site, and baseline PD-L1 status.||Comparison based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG performance status (0 versus 1), geographic region of the enrolling site (East Asia versus non-East Asia), and Baseline PD-L1 Status (\<50% versus \>=50%).||1.21|0.62|0.4084
72483382|NCT03829319|144493501|OTHER||Hazard Ratio (HR)|1.04||||0.7955|TWO_SIDED|95.0|0.79|1.36|||Stratified Log Rank|Two-sided p-value based on log-rank test stratified by ECOG performance status, geographic region of the enrolling site, and baseline PD-L1 status.||Comparison based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG performance status (0 versus 1), geographic region of the enrolling site (East Asia versus non-East Asia), and Baseline PD-L1 Status (\<50% versus \>=50%).||1.36|0.79|0.7955
72483383|NCT03829319|144493503|OTHER||Hazard Ratio (HR)|1.04||||0.7191|TWO_SIDED|95.0|0.84|1.28|||Stratified Log Rank|Two-sided p-value based on log-rank test stratified by ECOG performance status, geographic region of the enrolling site, and baseline PD-L1 status.||Comparison based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG performance status (0 versus 1), geographic region of the enrolling site (East Asia versus non-East Asia), and Baseline PD-L1 Status (\<50% versus \>=50%).||1.28|0.84|0.7191
72511923|NCT00948818|144553912|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.41||||0.0262|TWO_SIDED|95.0|1.04|1.91||The p-value is still less than 0.05 after adjusting multiplicity using a serial gatekeeping multiple comparison procedure.|Cochran-Mantel-Haenszel|||"Null Hypothesis: There is no difference between the 290 μg dose and placebo groups in the proportion of 9/12 Week Abdominal Pain Responders.~The power, adjusted for multiplicity, was expected to be 93% based on NCT00460811 (MCP-103-202) study data."||1.91|1.04|0.0262
72511924|NCT00948818|144553913|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.93|||<|0.0001|TWO_SIDED|95.0|1.4|2.66||The p-value is still less than 0.05 after adjusting multiplicity using a serial gatekeeping multiple comparison procedure.|Cochran-Mantel-Haenszel|||"Null Hypothesis: There is no difference between the 290 μg dose and placebo groups in the proportion of 6/12 Week APC + 1 Responders.~The power, adjusted for multiplicity, was expected to be 86% based on NCT00460811 (MCP-103-202) study data."||2.66|1.40|<0.0001
72511925|NCT01290445|144553931|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.82|||||TWO_SIDED|95.0|0.46|1.47||||||Crude prevalence odds ratios were estimated along with 95% confidence intervals using logistic regression models.||1.47|0.46|
72511926|NCT01290445|144553931|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.8|||||TWO_SIDED|95.0|0.45|1.42||||||Adjusted prevalence odds ratios were estimated along with 95% confidence intervals using logistic regression models.||1.42|0.45|
72483384|NCT04498832|144493504|SUPERIORITY|Superiority of GMTs was concluded if the lower limit of the 2-sided 95% Confidence Interval (CI) for the ratio of GMTs was greater than (\>) 1 between groups for each of the comparisons.|GMT ratio|2.81|||||TWO_SIDED|95.0|2.46|3.2|||||The 2-sided 95% CI was based on the student t-distribution of logarithmic transformation of the individual titers. Antilog transformations were applied to the results.|A/H1N1||3.20|2.46|
72483385|NCT04498832|144493504|SUPERIORITY|Superiority of GMTs was concluded if the lower limit of the 2-sided 95%CI for the ratio of GMTs was \>1 between groups for each of the comparisons.|GMT ratio|2.25|||||TWO_SIDED|95.0|2.03|2.5|||||The 2-sided 95% CI was based on the student t-distribution of logarithmic transformation of the individual titers. Antilog transformations were applied to the results.|A/H3N2-like||2.50|2.03|
72483386|NCT04498832|144493504|SUPERIORITY|Superiority of GMTs was concluded if the lower limit of the 2-sided 95%CI for the ratio of GMTs was \>1 between groups for each of the comparisons.|GMT ratio|2.55|||||TWO_SIDED|95.0|2.31|2.81|||||The 2-sided 95% CI was based on the student t-distribution of logarithmic transformation of the individual titers. Antilog transformations were applied to the results.|B/Victoria-like||2.81|2.31|
72483387|NCT04498832|144493504|SUPERIORITY|Superiority of GMTs was concluded if the lower limit of the 2-sided 95%CI for the ratio of GMTs was \>1 between groups for each of the comparisons.|GMT ratio|3.12|||||TWO_SIDED|95.0|2.85|3.42|||||The 2-sided 95% CI was based on the student t-distribution of logarithmic transformation of the individual titers. Antilog transformations were applied to the results.|B/Yamagata||3.42|2.85|
72483388|NCT04498832|144493505|SUPERIORITY|Superiority on seroconversions was concluded if the lower limit of the 2-sided 95% CI of the difference in percentage between groups was \> 0% for each of the comparisons.|Difference in percentage|29.7|||||TWO_SIDED|95.0|25.7|33.5|||||The 2-sided 95% CI for the difference was based on the Wilson score method without continuity correction.|A/H1N1||33.5|25.7|
72483389|NCT04498832|144493505|SUPERIORITY|Superiority on seroconversions was concluded if the lower limit of the 2-sided 95% CI of the difference in percentage between groups was \> 0% for each of the comparisons.|Difference in percentage|28.1|||||TWO_SIDED|95.0|24.0|32.0|||||The 2-sided 95% CI for the difference was based on the Wilson score method without continuity correction.|A/H3N2-like||32.0|24.0|
72483390|NCT04498832|144493505|SUPERIORITY|Superiority on seroconversions was concluded if the lower limit of the 2-sided 95% CI of the difference in percentage between groups was \> 0% for each of the comparisons.|Difference in percentage|31.4|||||TWO_SIDED|95.0|27.4|35.2|||||The 2-sided 95% CI for the difference was based on the Wilson score method without continuity correction.|B/Victoria-like||35.2|27.4|
72483391|NCT04498832|144493505|SUPERIORITY|Superiority on seroconversions was concluded if the lower limit of the 2-sided 95% CI of the difference in percentage between groups was \> 0% for each of the comparisons.|Difference in percentage|35.4|||||TWO_SIDED|95.0|31.4|39.3|||||The 2-sided 95% CI for the difference was based on the Wilson score method without continuity correction.|B/Yamagata||39.3|31.4|
72483392|NCT05090995|144493522|OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||<0.0001
72483393|NCT05090995|144493523|OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||<0.0001
72483394|NCT05090995|144493524|OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||<0.0001
72483395|NCT05090995|144493525|OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||<0.0001
72511927|NCT01290445|144553932|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.61|||||TWO_SIDED|95.0|0.09|4.34||||||Crude prevalence odds ratios were estimated along with 95% confidence intervals using logistic regression models.||4.34|0.09|
72511928|NCT01290445|144553932|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.65|||||TWO_SIDED|95.0|0.09|4.67||||||Adjusted prevalence odds ratios were estimated along with 95% confidence intervals using logistic regression models.||4.67|0.09|
72483396|NCT05090995|144493526|OTHER||||||<|0.0001|||||||Mixed Models Analysis|||For baseline consequences||||<.0001
72511929|NCT01290445|144553933|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.7|||||TWO_SIDED|95.0|0.5|0.96||||||Crude prevalence odds ratios were estimated along with 95% confidence intervals using logistic regression models.||0.96|0.50|
72483397|NCT05090995|144493526|OTHER||||||<|0.0001|||||||Mixed Models Analysis|||For effects with time||||<.0001
72483398|NCT05090995|144493527|OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||<.0001
72483399|NCT05090995|144493528|OTHER||||||<|0.0001|||||||Mixed Models Analysis|||Effect of baseline sleep scores||||<.0001
72483400|NCT05090995|144493528|OTHER|||||||0.04|||||||Mixed Models Analysis|||For effects with time||||0.04
72483401|NCT05090995|144493529|OTHER|||||||0.02|||||||Mixed Models Analysis|||For interaction between treatment group and time||||0.02
72483402|NCT05090995|144493529|OTHER|||||||0.02|||||||Mixed Models Analysis|||Main effects of sex||||0.02
72483403|NCT05090995|144493529|OTHER|||||||0.0007|||||||Mixed Models Analysis|||Main effects of type of day of the week (weekday vs. weekend)||||0.0007
72483404|NCT05090995|144493529|OTHER|||||||0.02|||||||Mixed Models Analysis|||||||0.02
72483405|NCT05090995|144493530|OTHER|||||||0.0001|||||||Mixed Models Analysis|||Main effect of day of the week.||||0.0001
72483406|NCT05090995|144493531|OTHER|||||||0.04|||||||Mixed Models Analysis|||For interaction between treatment condition and time||||0.04
72483407|NCT05090995|144493531|OTHER||||||<|0.0001|||||||Mixed Models Analysis|||Main effects of sex||||<.0001
72483408|NCT05090995|144493531|OTHER||||||<|0.0001|||||||Mixed Models Analysis|||Main effects of type of day of the week (weekday vs. weekend)||||<0.0001
72483409|NCT05090995|144493531|OTHER|||||||0.03|||||||Mixed Models Analysis|||||||0.03
72511930|NCT01290445|144553933|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.7|||||TWO_SIDED|95.0|0.51|0.97||||||Adjusted prevalence odds ratios were estimated along with 95% confidence intervals using logistic regression models.||0.97|0.51|
72511931|NCT01290445|144553934|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.95|||||TWO_SIDED|95.0|0.63|1.42||||||Crude prevalence odds ratios were estimated along with 95% confidence intervals using logistic regression models.||1.42|0.63|
72483410|NCT03049735|144493536|SUPERIORITY||Treatment difference|54.54|||<|0.0001|TWO_SIDED|95.0|44.3|64.78||P-value was stratified by baseline MBL volume (\< 225 mL or ≥ 225 mL) and geographic region (North America or Rest of World). Assessed at a 2-sided α = 0.05 significance level.|Cochran-Mantel-Haenszel||Treatment difference is relugolix + E2/NETA minus placebo.|The primary efficacy analysis was the comparison of the relugolix + E2/NETA group with the placebo group with respect to responder rate.||64.78|44.3|<0.0001
72483411|NCT03049735|144493537|SUPERIORITY||Treatment difference|46.83|||<|0.0001|TWO_SIDED|95.0|37.31|56.35||P-value was based on Cochran-Mantel-Haenszel test stratified by Baseline MBL volume (\< 225 mL, ≥ 225 mL) and geographic region (North America or Rest of World). Assessed at a 2-sided α = 0.05 significance level.|Cochran-Mantel-Haenszel||Treatment difference was relugolix plus E2/NETA minus placebo. 95% confidence interval (CI) for difference is based on the normal approximation.|||56.35|37.31|<0.0001
72483412|NCT03049735|144493538|SUPERIORITY||Treatment difference|-61.1|STANDARD_ERROR_OF_MEAN|6.32|<|0.0001|TWO_SIDED|95.0|-73.5|-48.6||Treatment, visit, region, Baseline MBL and treatment by visit interaction included as fixed effects. The multiple visits for each participant were the repeated measures as random effect within each participant and an unstructured covariance.|Mixed Models Analysis|Assessed at a 2-sided α = 0.05 significance. Treatment difference is relugolix plus E2/NETA minus placebo.||||-48.6|-73.5|<0.0001
72483413|NCT03049735|144493539|SUPERIORITY||Treatment difference|28.26|||=|0.0377|TWO_SIDED|95.0|3.68|52.84||P-value is based on Cochran-Mantel-Haenszel test stratified by Baseline MBL volume (\< 225 mL, ≥ 225 mL). Assessed at a 2-sided α = 0.05 significance level.|Cochran-Mantel-Haenszel||Treatment difference is relugolix plus E2/NETA minus placebo. 95% CI for difference is based on the normal approximation.|||52.84|3.68|= 0.0377
72483414|NCT03049735|144493540|SUPERIORITY||Treatment difference|33.0|||<|0.0001|TWO_SIDED|95.0|18.36|47.56||P-value is based on Cochran-Mantel-Haenszel test stratified by Baseline MBL volume (\< 225 mL, ≥ 225 mL). Assessed at a 2-sided α = 0.05 significance level.|Cochran-Mantel-Haenszel||Treatment difference is relugolix plus E2/NETA minus placebo. 95% CI for difference is based on the normal approximation.|||47.56|18.36|<0.0001
72483415|NCT03049735|144493541|SUPERIORITY||Treatment difference|-12.1|STANDARD_ERROR_OF_MEAN|7.19||0.0921|TWO_SIDED|95.0|-26.3|2.0||Based on analysis of covariance model with treatment, randomization stratification factors, Baseline MBL volume, geographic region (North America, Rest of World), and Baseline values as covariate. Assessed at a 2-sided α = 0.05 significance level.|ANCOVA|||||2|-26.3|0.0921
72483416|NCT03049735|144493542|SUPERIORITY||Treatment difference|-15.1|STANDARD_ERROR_OF_MEAN|3.98||0.0002|TWO_SIDED|95.0|-23.0|-7.3||Based on analysis of covariance model with treatment, randomization stratification factors, Baseline MBL volume, geographic region (North America, Rest of World), and Baseline values as covariate. Assessed at a 2-sided α = 0.05 significance level.|ANCOVA|||||-7.3|-23|0.0002
72483417|NCT03049735|144493543|SUPERIORITY||Treatment difference|-28.9|STANDARD_ERROR_OF_MEAN|3.75|<|0.0001|TWO_SIDED|95.0|-36.3|-21.5||Treatment, visit, region, Baseline MBL and treatment by visit interaction included as fixed effects. The multiple visits for each participant were the repeated measures as random effect within each participant and an unstructured covariance.|Mixed Models Analysis|Assessed at a 2-sided α = 0.05 significance level. LS means and p-value for test of difference is relugolix plus E2/NETA minus placebo.||||-21.5|-36.3|<0.0001
72483418|NCT03049735|144493546|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||||||<0.0001
72483419|NCT03049735|144493551|SUPERIORITY||||||<|0.0001||||||P-value is based on Log-rank test stratified by Baseline MBL volume (\< 225 mL, ≥ 225 mL) and geographic region (North America, Rest of World) from the proportional hazard regression model comparing relugolix + E2/NETA with placebo.|Log Rank|||||||<0.0001
72483420|NCT03049735|144493552|SUPERIORITY||||||<|0.0001||||||P-value for testing difference between relugolix plus E2/NETA and placebo is based on Cochran-Mantel-Haenszel test stratified by Baseline MBL volume (\< 225 mL, ≥ 225 mL) and geographic region (North America, Rest of World).|Cochran-Mantel-Haenszel|||||||<0.0001
72483421|NCT03049735|144493553|SUPERIORITY||||||<|0.0001||||||P-value is based on Log-rank test stratified by Baseline MBL volume (\< 225 mL, ≥ 225 mL) and geographic region (North America, Rest of World) from the proportional hazard regression model comparing relugolix plus E2/NETA with placebo.|Log Rank|||||||<0.0001
72511932|NCT01290445|144553934|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.91|||||TWO_SIDED|95.0|0.61|1.37||||||Adjusted prevalence odds ratios were estimated along with 95% confidence intervals using logistic regression models.||1.37|0.61|
72511933|NCT01290445|144553935|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.65|||||TWO_SIDED|95.0|0.37|1.16||||||Crude prevalence odds ratios were estimated along with 95% confidence intervals using logistic regression models.||1.16|0.37|
72483422|NCT03049735|144493554|SUPERIORITY||||||<|0.0001||||||P-value was based on Log-rank test stratified by Baseline MBL volume (\< 225 mL, ≥ 225 mL) and geographic region (North America, Rest of World) from the proportional hazard regression model comparing relugolix + E2/NETA with placebo.|Log Rank|||||||<0.0001
72511934|NCT01290445|144553935|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.65|||||TWO_SIDED|95.0|0.37|1.16||||||Adjusted prevalence odds ratios were estimated along with 95% confidence intervals using logistic regression models.||1.16|0.37|
72511935|NCT05439460|144553941|OTHER|||||||0.9|||||||t-test, 2 sided|||Change in phenylephrine group||||0.9
72483423|NCT03049735|144493555|SUPERIORITY|||||||0.0377||||||P-value was based on Cochran-Mantel-Haenszel test stratified by Baseline MBL volume (\< 225 mL, ≥ 225 mL).|Cochran-Mantel-Haenszel|||||||0.0377
72511936|NCT05439460|144553941|OTHER|||||||0.3||||||A p-value of \<0.05 would be considered statistically significant.|t-test, 2 sided|||Change in arginine vasopressin group||||0.3
72511937|NCT05439460|144553941|OTHER|||||||1||||||A p-value of \<0.05 would be considered statistically significant.|t-test, 2 sided|||Change in epinephrine group||||1
72511938|NCT03446651|144553942|SUPERIORITY|||||||0.56|||||||t-test, 2 sided|||||||0.56
72511939|NCT03446651|144553944|SUPERIORITY|||||||0.039|||||||t-test, 2 sided|||||||0.039
72483424|NCT03049735|144493556|SUPERIORITY|||||||0.0117||||||Treatment, visit, region, Baseline MBL and treatment by visit interaction included as fixed effects. The multiple visits for each participant were the repeated measures as random effect within each participant and an unstructured covariance.|Mixed Models Analysis|LS means and p-value for test of difference is relugolix plus E2/NETA minus placebo.||||||0.0117
72483425|NCT03049735|144493557|SUPERIORITY|||||||0.0084||||||P-value was based on Cochran-Mantel-Haenszel test stratified by Baseline MBL volume (\< 225 mL, ≥ 225 mL) and geographic region (North America, Rest of World). Lower limit of normal is Hgb \< 11.6 g/dL.|Cochran-Mantel-Haenszel|||||||0.0084
72483426|NCT03049735|144493558|SUPERIORITY||||||<|0.0001||||||Treatment, visit, region, Baseline MBL and treatment by visit interaction included as fixed effects. The multiple visits for each participant were the repeated measures as random effect within each participant and an unstructured covariance.|Mixed Models Analysis|LS means and p-value for test of difference is relugolix plus E2/NETA minus placebo.||||||<0.0001
72483427|NCT03049735|144493559|SUPERIORITY||||||<|0.0001||||||Treatment, visit, region, Baseline MBL and treatment by visit interaction included as fixed effects. The multiple visits for each participant were the repeated measures as random effect within each participant and an unstructured covariance.|Mixed Models Analysis|LS means and p-value for test of difference is relugolix plus E2/NETA minus placebo.||||||<0.0001
72483428|NCT03049735|144493560|SUPERIORITY||||||<|0.0001||||||Treatment, visit, region, Baseline MBL and treatment by visit interaction included as fixed effects. The multiple visits for each participant were the repeated measures as random effect within each participant and an unstructured covariance.|Mixed Models Analysis|LS means and p-value for test of difference is relugolix plus E2/NETA minus placebo.||||||<0.0001
72483429|NCT03049735|144493561|SUPERIORITY||||||<|0.0001||||||Treatment, visit, region, Baseline MBL and treatment by visit interaction included as fixed effects. The multiple visits for each participant were the repeated measures as random effect within each participant and an unstructured covariance.|Mixed Models Analysis|LS means and p-value for test of difference is relugolix plus E2/NETA minus placebo.||||||<0.0001
72483430|NCT03049735|144493562|SUPERIORITY||||||<|0.0001||||||P-value for testing difference between Relugolix plus E2/NETA and placebo is based on Cochran-Mantel-Haenszel test stratified by Baseline MBL volume (\< 225 mL, ≥ 225 mL) and geographic region (North America, Rest of World).|Cochran-Mantel-Haenszel|||||||<0.0001
72483431|NCT03049735|144493563|SUPERIORITY||||||<|0.0001||||||Treatment, visit, region, Baseline MBL and treatment by visit interaction included as fixed effects. The multiple visits for each participant were the repeated measures as random effect within each participant and an unstructured covariance.|Mixed Models Analysis|LS means and p-value for test of difference is relugolix plus E2/NETA minus placebo.||||||<0.0001
72483432|NCT03049735|144493564|SUPERIORITY||||||<|0.0001||||||P-value was based on Cochran-Mantel-Haenszel test stratified by Baseline MBL volume (\< 225 mL, ≥ 225 mL) and geographic region (North America, Rest of World).|Cochran-Mantel-Haenszel|||||||<0.0001
72483433|NCT03049735|144493565|SUPERIORITY||||||<|0.0001||||||Treatment, visit, region, Baseline MBL and treatment by visit interaction included as fixed effects. The multiple visits for each participant were the repeated measures as random effect within each participant and an unstructured covariance.|Mixed Models Analysis|LS means and p-value for test of difference is relugolix plus E2/NETA minus placebo.||||||<0.0001
72511940|NCT03446651|144553946|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
72483434|NCT03049735|144493566|SUPERIORITY||||||<|0.0001||||||Treatment, visit, region, Baseline MBL and treatment by visit interaction included as fixed effects. The multiple visits for each participant were the repeated measures as random effect within each participant and an unstructured covariance.|Mixed Models Analysis|LS means and p-value for test of difference is relugolix plus E2/NETA minus placebo.||||||<0.0001
72511941|NCT03446651|144553947|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
72511942|NCT04131517|144553948|OTHER|A lack of PSL effect on EE and LN would have been concluded if the 90% CI of the geometric mean ratio between treatment with PSL + OC and OC Alone of the least squares (LS) means for the log-transformed Cmax was within the bioequivalence acceptance range of 80% to 125%.|Geometric LS Mean ratio|1.0404|||||TWO_SIDED|90.0|0.94156|1.1497||||||The analysis of variance model (ANOVA) included Treatment, Period, and Sequence as fixed effects and participant within Sequence as a random effect.||1.1497|0.94156|
72511943|NCT04131517|144553949|OTHER|A lack of PSL effect on EE and LN would have been concluded if the 90% CI of the geometric mean ratio between treatment with PSL + OC and OC Alone of the LS means for the log-transformed Cmax was within the bioequivalence acceptance range of 80% to 125%.|Geometric LS Mean ratio|0.89272|||||TWO_SIDED|90.0|0.76892|1.0364||||||The ANOVA model included Treatment, Period, and Sequence as fixed effects and participant within Sequence as a random effect.||1.0364|0.76892|
72511944|NCT04131517|144553952|OTHER|A lack of PSL effect on EE and LN would have been concluded if the 90% CI of the geometric mean ratio between treatment with PSL + OC and OC Alone of the LS means for the log-transformed AUC0-inf was within the bioequivalence acceptance range of 80% to 125%.|Geometric LS Mean ratio|1.0276|||||TWO_SIDED|90.0|0.95544|1.1052||||||The ANOVA model included Treatment, Period, and Sequence as fixed effects and participant within Sequence as a random effect.||1.1052|0.95544|
72511945|NCT04131517|144553953|OTHER|A lack of PSL effect on EE and LN would have been concluded if the 90% CI of the geometric mean ratio between treatment with PSL+ OC and OC Alone of the LS means for the log-transformed AUC0-inf was within the bioequivalence acceptance range of 80% to 125%.|Geometric LS Mean ratio|0.88808|||||TWO_SIDED|90.0|0.52185|1.5113||||||The ANOVA model included Treatment, Period, and Sequence as fixed effects and participant within Sequence as a random effect.||1.5113|0.52185|
72511946|NCT04131517|144553960|OTHER|A lack of PSL effect on EE and LN would have been concluded if the 90% CI of the geometric mean ratio between treatment with PSL + OC and OC Alone of the LS means for the log-transformed Cmax was within the bioequivalence acceptance range of 80% to 125%.|Geometric LS Mean ratio|0.96378|||||TWO_SIDED|90.0|0.85043|1.0922||||||The ANOVA model included Treatment, Period, and Sequence as fixed effects and participant within Sequence as a random effect.||1.0922|0.85043|
72483435|NCT03049735|144493568|SUPERIORITY||||||<|0.0001||||||Treatment, visit, region, Baseline MBL and treatment by visit interaction included as fixed effects. The multiple visits for each participant were the repeated measures as random effect within each participant and an unstructured covariance.|Mixed Models Analysis|LS means and p-value for test of difference is relugolix plus E2/NETA minus placebo.||||||<0.0001
72483436|NCT03049735|144493575|SUPERIORITY|||||||0.0002||||||P-value was based on Cochran-Mantel-Haenszel test stratified by Baseline MBL volume (\< 225 mL, ≥ 225 mL).|Cochran-Mantel-Haenszel|||||||0.0002
72483437|NCT03153111|144493580|SUPERIORITY||Geometric mean ratio|1.02||||0.7923|TWO_SIDED|90.0|0.88|1.19|||ANCOVA|||||1.19|0.88|0.7923
72483438|NCT03153111|144493581|SUPERIORITY||Least square mean difference|-3.5|STANDARD_ERROR_OF_MEAN|2.82||0.2172|TWO_SIDED|90.0|-8.17|1.17|||ANCOVA|||||1.17|-8.17|0.2172
72483439|NCT03153111|144493582|SUPERIORITY||Least square mean difference|-0.02|STANDARD_ERROR_OF_MEAN|0.02||0.3665|TWO_SIDED|90.0|-0.05|0.02|||ANCOVA|||||0.02|-0.05|0.3665
72483440|NCT03891524|144493612|OTHER|||||||0.0004|||||||MCP-mod analysis|||||||0.0004
72483441|NCT03891524|144493613|OTHER|||||||0.7188|||||||MCP-MOD analysis|||||||0.7188
72483442|NCT01389765|144493647|SUPERIORITY_OR_OTHER||Ratio of Geometric Least Squares Means|1.01|||||TWO_SIDED|90.0|0.97|1.05|||Mixed Models Analysis|Analyzed was a ratio of geometric LS means between the 2 treatment states (fed/fasted), and the 90% confidence interval for the ratio.||||1.05|0.97|
72483443|NCT01389765|144493648|SUPERIORITY_OR_OTHER||Ratio of Geometric Least Squares Means|0.96|||||TWO_SIDED|90.0|0.92|1.01|||Mixed Models Analysis|Analyzed was a ratio of geometric LS means between the 2 treatments states (fed/fasted), and the 90% confidence interval for the ratio.||||1.01|0.92|
72483444|NCT01389765|144493649|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|1.0||||0.0031|TWO_SIDED|90.0|0.5|1.5|||Wilcoxon (Mann-Whitney)|Analyzed were the median of paired differences between the 2 treatment states (fed versus fasted) and the 90% confidence interval.||||1.50|0.50|0.0031
72483445|NCT03877432|144493650|SUPERIORITY|||||||0.012|||||||ANOVA|||All data were presented as means ± standard deviations (SDs). Analysis of variance (ANOVA) was used to compare the effects of 1T stimulation amplitude changes on bladder capacity.||||0.012
72483446|NCT03877432|144493650|SUPERIORITY|||||||0.017|||||||ANOVA|||All data were presented as means ± standard deviations (SDs). Analysis of variance (ANOVA) was used to compare the effects of 2T stimulation amplitude changes on bladder capacity.||||0.017
72483447|NCT03877432|144493650|SUPERIORITY|||||||0.003|||||||ANOVA|||All data were presented as means ± standard deviations (SDs). Analysis of variance (ANOVA) was used to compare the effects of 3T stimulation amplitude changes on bladder capacity.||||0.003
72483448|NCT03877432|144493650|SUPERIORITY|||||||0.004|||||||ANOVA|||All data were presented as means ± standard deviations (SDs). Analysis of variance (ANOVA) was used to compare the effects of 4T stimulation amplitude changes on bladder capacity.||||0.004
72483449|NCT00174265|144493652|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0148||95.0||||The test of hypothesis was a 2-tailed test with alpha=0.05 (0.049 to adjust for one interim analysis).|Mixed Model for Repeated Measurements|||The null hypothesis was that there was no difference in change from Baseline in NSA Scale total score between asenapine and olanzapine at Day 365.||||0.0148
72483450|NCT00174265|144493653|SUPERIORITY_OR_OTHER_LEGACY|||||||0.81||95.0||||Significant level adjusted for one interim analysis was set as 0.049 two-sided.|Mixed Model for Repeated Measurements|||The null hypothesis was that there was no difference in change from Baseline in QLS total score between asenapine and olanzapine at Week 52.||||0.8100
72483451|NCT01474863|144493654|SUPERIORITY|||||||0.86|||||||ANOVA|||||||0.86
72511947|NCT04131517|144553962|OTHER|A lack of PSL effect on EE and LN would have been concluded if the 90% CI of the geometric mean ratio between treatment with PSL + OC and OC Alone of the LS means for the log-transformed AUC was within the bioequivalence acceptance range of 80% to 125%.|Geometric LS Mean ratio|0.96842|||||TWO_SIDED|90.0|0.91888|1.0206||||||The ANOVA model included Treatment, Period, and Sequence as fixed effects and participant within Sequence as a random effect.||1.0206|0.91888|
72567229|NCT01939496|144665391|SUPERIORITY_OR_OTHER||Difference of Least Square Means|-3.29|STANDARD_ERROR_OF_MEAN|1.748||0.062|TWO_SIDED|95.0|-6.743|0.163|||ANCOVA|||||0.163|-6.743|0.062
72567230|NCT01939496|144665391|SUPERIORITY_OR_OTHER||Difference of Least Square Means|-4.93|STANDARD_ERROR_OF_MEAN|1.75||0.006|TWO_SIDED|95.0|-8.382|-1.469|||ANCOVA|||||-1.469|-8.382|0.006
72483452|NCT03040622|144493670|OTHER|||||||0.06|||||||ANOVA|||||||0.06
72483453|NCT03040622|144493671|OTHER|||||||0.009|||||||ANOVA|||||||0.009
72483454|NCT03040622|144493672|OTHER|||||||0.001|||||||ANOVA|||||||0.001
72483455|NCT00447382|144493686|SUPERIORITY_OR_OTHER_LEGACY||Treatment Ratio|1.04||||0.649||95.0|0.86|1.26|||ANOVA|Treatment, previous insulin detemir exposure and country as fixed effects and the baseline value as a covariate. (Log transformed data).|The treatment ratio calculated is the NN729-NN304 ratio for the change from baseline to Week 52. The 95% confidence interval for this ratio was also calculated.|"Null hypothesis:Treatment with detemir produced with the NN729 process result in a similar change in cross reacting antibody levels as the NN304 process. Alternative hypothesis: change in antibody levels differ after treatment with detemir produced by the two manufacturing processes.~The statistical analysis applies to the change from baseline to week 52 which was analysed using ANOVA."||1.26|0.86|0.649
72483456|NCT00447382|144493688|SUPERIORITY_OR_OTHER_LEGACY||Estimated treatment difference|-0.03||||0.758||95.0|-0.21|0.15|||ANOVA|Adjustments: Treatment, previous insulin detemir exposure and country as fixed effects and the baseline value as covariate.|The estimated treatment difference calculated is the NN729-NN304 treatment difference for the change from baseline to Week 52. The 95% confidence interval for this difference was also calculated.|The statistical analysis applies to the change from baseline to week 52 which was analysed using ANOVA.||0.15|-0.21|0.758
72483457|NCT00447382|144493689|SUPERIORITY_OR_OTHER_LEGACY||Estimated treatment difference|-0.1||||0.812||95.0|-0.89|0.7|||ANOVA|Adjustments: Treatment, previous insulin detemir exposure and country as fixed effects and the baseline value as covariate.|The estimated treatment difference calculated is the NN729-NN304 treatment difference for the change from baseline to Week 52. The 95% confidence interval for this difference was also calculated|The statistical analysis applies to the change from baseline to week 52 which was analysed using ANOVA.||0.7|-0.89|0.812
72483458|NCT00447382|144493691|SUPERIORITY_OR_OTHER_LEGACY||Treatment Ratio|0.93||||0.15||95.0|0.84|1.03|||ANOVA|Adjustments:Treatment, previous insulin detemir exposure and country as fixed effects and the baseline value as a covariate. (Log transformed data)|The treatment ratio calculated is the NN729-NN304 ratio for the change from baseline to Week 52. The 95% confidence interval for this ratio was also calculated.|The statistical analysis applies to the change from baseline to week 52 which was analysed using ANOVA. The analysis was based on an assumption of a log-normal distribution for antibody data and was thus built on log-transformed data.||1.03|0.84|0.15
72624054|NCT05852470|144778451|SUPERIORITY||Difference in Means|-0.091|STANDARD_ERROR_OF_MEAN|0.0151|<|0.001|TWO_SIDED|95.0|-0.12|-0.061|||t-test, 1 sided||||Parameter Dispersion Type is Standard Error of the Difference in Means. Difference = Vivity/Vivity Toric Extended Vision IOL minus Clareon/Clareon Toric Monofocal IOL|-0.061|-0.120|<.001
72483459|NCT00447382|144493692|SUPERIORITY_OR_OTHER_LEGACY||Treatment Ratio|1.0||||0.966||95.0|0.87|1.15|||ANOVA|Adjustments: Treatment, previous insulin detemir exposure and country as fixed effects and the baseline value as a covariate. (Log transformed data)|The treatment ratio calculated is the NN729-NN304 ratio for the change from baseline to Week 52. The 95% confidence interval for this ratio was also calculated.|The statistical analysis applies to the change from baseline to week 52 which was analysed using ANOVA. The analysis was based on an assumption of a log-normal distribution for antibody data and was thus built on log-transformed data.||1.15|0.87|0.966
72483460|NCT04600336|144493710|SUPERIORITY||Mean Difference (Final Values)|-9.11||||0.0019|TWO_SIDED|90.0|-13.76|-4.46|||t-test, 2 sided|||||-4.46|-13.76|0.0019
72402273|NCT01480076|144311669|SUPERIORITY_OR_OTHER||least squares mean|-3.1|STANDARD_ERROR_OF_MEAN|0.75|<|0.0001|TWO_SIDED||||||mixed effect model|||Month 9, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of the total activity limitation score of PRIMUS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
72483461|NCT04600336|144493710|SUPERIORITY||Mean Difference (Final Values)|-5.09||||0.0732|TWO_SIDED|90.0|-9.7|-0.48|||t-test, 2 sided|||||-0.48|-9.70|0.0732
72483462|NCT04600336|144493713|SUPERIORITY|||||||0.012|||||||Kruskal-Wallis|||||||0.0120
72483463|NCT04600336|144493716|SUPERIORITY|||||||0.0057|||||||Kruskal-Wallis|||||||0.0057
72483464|NCT04091451|144493727|NON_INFERIORITY|The non-inferiority was to be demonstrated if the upper limit (UL) of the 95% confidence interval (CI) of the ratio of the incidence of HZ recurrence between HZ/su group and Placebo group was below (\<) 5.|Incidence Rate Ratio (IRR)|0.0|||||TWO_SIDED|95.0|0.0|0.46|||Poisson||IRR = incidence rate of HZ recurrence in HZ/su group divided by the incidence rate of HZ recurrence in Placebo group. Poisson method was used to adjust for differences in follow-up time across individuals.|To demonstrate the non-inferiority of HZ/su vaccine compared to placebo in terms of incidence of HZ recurrence from 30 days post-second vaccination (Month 3) until study end (duration of approximately 2 years to 4 years and 5 months).||0.46|0.00|
72483465|NCT02087748|144493812|SUPERIORITY_OR_OTHER|||||||0.0324|||||||t-test, 2 sided|||||||0.0324
72483466|NCT02087748|144493813|SUPERIORITY_OR_OTHER|||||||0.3688|||||||t-test, 2 sided|||||||0.3688
72483467|NCT02087748|144493814|SUPERIORITY_OR_OTHER|||||||0.0275|||||||t-test, 2 sided|||||||0.0275
72483468|NCT03078907|144493817|OTHER||Least Square (LS) mean|13.79|STANDARD_ERROR_OF_MEAN|13.695|||TWO_SIDED|95.0|13.366|40.944|||ANCOVA|||Daily time spent in non-sedentary activity (minutes), Freedson '98||40.944|13.366|
72483469|NCT03078907|144493817|OTHER||LS means|2.31|STANDARD_ERROR_OF_MEAN|6.601|||TWO_SIDED|95.0|-10.782|15.396|||ANCOVA|||Daily time spent in MVPA (minutes), Freedson '98||15.396|-10.782|
72483470|NCT03078907|144493817|OTHER||LS mean|17.81|STANDARD_ERROR_OF_MEAN|12.008|||TWO_SIDED|95.0|-6.003|41.619|||ANCOVA|||Daily time spent in non-sedentary activity (minutes), Koster '16||41.619|-6.003|
72483471|NCT03078907|144493818|OTHER||LS mean|0.67|STANDARD_ERROR_OF_MEAN|1.204|||TWO_SIDED|95.0|-1.713|3.06|||ANCOVA|||Percentage of daily time spent in non-sedentary activity (%), Freedson '98||3.060|-1.713|
72483472|NCT03078907|144493818|OTHER||LS mean|-0.05|STANDARD_ERROR_OF_MEAN|0.658|||TWO_SIDED|95.0|-1.351|1.258|||ANCOVA|||Percentage of daily time spent in MVPA (%), Freedson '98||1.258|-1.351|
72483473|NCT03078907|144493818|OTHER||LS mean|1.26|STANDARD_ERROR_OF_MEAN|1.191|||TWO_SIDED|95.0|-1.104|3.618|||ANCOVA|||Percentage of daily time spent in non-sedentary activity (%), Koster '16||3.618|-1.104|
72567231|NCT02278718|144665473|SUPERIORITY|||||||0.0008|||||||Generalized Wilcoxon-Gehan Test|||Wilcoxon test statistic was estimated using generalized Wilcoxon-Gehan test stratified by center group, age group, % TBSA group, proportion of FT area group and number of TWs group. A negative (positive) statistic is associated with longer (shorter) time to the event when treated with NexoBrid vs. Standard of Care. P-value was calculated using the re-randomization test.||||0.0008
72483474|NCT03078907|144493819|OTHER||LS mean|20.66|STANDARD_ERROR_OF_MEAN|63.695|||TWO_SIDED|95.0|-105.632|146.958|||ANCOVA|||Volume of total daily activities (counts / minute)||146.958|-105.632|
72483475|NCT03078907|144493819|OTHER||LS means|27.52|STANDARD_ERROR_OF_MEAN|65.291|||TWO_SIDED|95.0|-101.945|156.976|||ANCOVA|||Volume of non-sedentary activity (counts/minute), Koster '16||156.976|-101.945|
72483476|NCT03078907|144493820|OTHER||LS means|58409.0|STANDARD_ERROR_OF_MEAN|64985.0|||TWO_SIDED|95.0|-70444.0|187263.0|||ANCOVA|||||187263|-70444|
72483477|NCT03078907|144493821|OTHER||LS means|201.59|STANDARD_ERROR_OF_MEAN|224.212|||TWO_SIDED|95.0|-242.977|646.163|||ANCOVA|||||646.163|-242.977|
72483478|NCT03078907|144493822|OTHER||LS means|0.07|STANDARD_ERROR_OF_MEAN|0.221|||TWO_SIDED|95.0|-0.366|0.51|||ANCOVA|||||0.510|-0.366|
72483479|NCT03808688|144493852|OTHER|Descriptive statistics included the number of subjects/eyes(n), mean, SD, median, minimum, and maximum for continuous variables, and frequency and percentages for categorical variables.||||||||||||||||Cohorts assessed versus baseline treatment|All efficacy data were summarized at each timepoint using appropriate descriptive statistics for the overall populations as well as separately for monotherapy and concomitant therapy groups.|||
72483480|NCT02993523|144493884|SUPERIORITY||Hazard Ratio (HR)|0.58|||<|0.001|TWO_SIDED|95.0|0.465|0.723||Stratified log-rank test stratified by age (18 - \< 75, ≥ 75) and cytogenetic risk (intermediate, poor).|Log Rank||HR from Cox proportional hazards model stratified by age (18 - \< 75, ≥ 75) and cytogenetic risk (intermediate, poor).|||0.723|0.465|<0.001
72483481|NCT02993523|144493885|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test stratified by age (18 - \< 75, ≥ 75) and cytogenetic risk (intermediate, poor).||||||<0.001
72483482|NCT03694418|144493893|OTHER||Incident Rate Ratio|1.73|STANDARD_DEVIATION|0.35|<|0.05|TWO_SIDED|95.0|1.02|2.95|||Wilcoxon (Mann-Whitney)|||||2.95|1.02|<0.05
72511948|NCT04149899|144553964|OTHER|The null hypothesis is that the mean change from Baseline, Hour 2 = 0 at Day 14, Hour 2.|Mean Difference (Net)|-4.9|STANDARD_DEVIATION|1.85|<|0.001|TWO_SIDED|95.0|-5.73|-4.14||The p-value was not adjusted for multiple comparisons.|t-test, 2 sided|||A within-group comparison was performed between Baseline, Hour 2 and Day 14, Hour 2, the timepoint for the peak effect of Timolol 0.5%.||-4.14|-5.73|<0.001
72567232|NCT02278718|144665474|SUPERIORITY||Odds Ratio (OR)|0.025|||<|0.0001|TWO_SIDED|95.0|0.007|0.09|||Fisher Exact|||Incidence of Surgical Excision for Eschar Removal for NexoBrid vs SOC||0.090|0.007|<0.0001
72567233|NCT02278718|144665475|SUPERIORITY|||||||0.1374|||||||t-test, 2 sided|||||||0.1374
72567234|NCT02278718|144665476|SUPERIORITY||Mean Difference (Final Values)|-6.9||||0.5045|TWO_SIDED||||||t-test, 2 sided|||||||0.5045
72483483|NCT03258554|144493903|SUPERIORITY||Hazard Ratio (HR)|1.33||||0.8878|TWO_SIDED|95.0|0.84|2.12||One-sided significance level = 0.2|Log Rank||Reference arm = radiation therapy + cetuximab|Sixty-nine progression-free survival (PFS) events provides 0.80 power for a log-rank test with one-sided alpha of 0.20 to detect an improvement in PFS corresponding to a median of 2.35 years (RT+Durvalumab) compared to 1.53 years (RT+Cetuximab). A hazard ratio (RT+Durvalumab/RT+Cetuximab) ≤ 0.806 would indicate a rejection of the null hypothesis (no difference between the arms) and the study would continue to phase III; otherwise, the study would not continue to phase III.||2.12|0.84|0.8878
72483484|NCT03258554|144493904|SUPERIORITY||Hazard Ratio (HR)|1.3||||0.8175|TWO_SIDED|95.0|0.74|2.28||One-side significance level = 0.025|Log Rank|||||2.28|0.74|0.8175
72483485|NCT03258554|144493905|SUPERIORITY||Hazard Ratio (HR)|1.71||||0.1001|TWO_SIDED|95.0|0.89|3.28||Two-sided significance level = 0.05|Log Rank||Reference level = RT+ Cetuximab|||3.28|0.89|0.1001
72567235|NCT02278718|144665477|SUPERIORITY||Odds Ratio (OR)|0.414||||0.0545|TWO_SIDED|95.0|0.163|1.054|||t-test, 2 sided|||||1.054|0.163|0.0545
72483486|NCT03258554|144493906|SUPERIORITY||Hazard Ratio (HR)|0.76||||0.5197|TWO_SIDED|95.0|0.32|1.77||Two-sided significance level = 0.05|Log Rank||Reference level = RT+ Cetuximab|||1.77|0.32|0.5197
72483487|NCT03258554|144493907|SUPERIORITY||Hazard Ratio (HR)|1.75||||0.3201|TWO_SIDED|95.0|0.57|5.38||Two-sided significance level = 0.05|Log Rank|||||5.38|0.57|0.3201
72483488|NCT03258554|144493908|SUPERIORITY|||||||1||||||Two-sided significance level = 0.05|Fisher Exact|||||||1.00
72483489|NCT03258554|144493909|SUPERIORITY|||||||0.0688||||||Two-side significance level = 0.05|Fisher Exact|||||||0.0688
72483490|NCT03258554|144493912|SUPERIORITY||Cox Proportional Hazard|1.11|||||TWO_SIDED|95.0|0.62|1.97|||||Reference arm = RT + Cetuximab|CPS ≥ 1||1.97|0.62|
72483491|NCT03258554|144493912|SUPERIORITY||Cox Proportional Hazard|1.64|||||TWO_SIDED|95.0|0.66|4.06|||||Reference arm = RT + Cetuximab|CPS = 0||4.06|0.66|
72483492|NCT03258554|144493912|SUPERIORITY|||||||0.41||||||Testing the interaction of treatment arm and PD-L1 expression (CPS ≥ 1, CPS = 0)|Regression, Cox|||Interaction||||0.41
72483493|NCT03258554|144493913|SUPERIORITY||Hazard Ratio (HR)|1.2|||||TWO_SIDED|95.0|0.57|2.51|||||Reference arm = RT + cetuximab|p16-positive||2.51|0.57|
72483494|NCT03258554|144493913|SUPERIORITY||Hazard Ratio (HR)|1.55|||||TWO_SIDED|95.0|0.83|2.89|||||Reference arm = RT + cetuximab|p16-negative||2.89|0.83|
72483495|NCT03258554|144493913|SUPERIORITY|||||||0.61||||||Testing the interaction of treatment arm and p16 status (positive, negative)|Regression, Cox|||Interaction||||0.61
72483496|NCT01601847|144493928|SUPERIORITY||Risk Ratio (RR)|0.66||||0.02|TWO_SIDED|95.0|0.47|0.94|||Poisson|Poisson regression using GEE with robust variance estimation (e.g. Zou, American Journal Epidemiology, 2004)||||0.94|0.47|0.02
72567236|NCT04440449|144665486|SUPERIORITY|||||||0.01|||||||t-test, 2 sided|||||||0.01
72567237|NCT04440449|144665487|SUPERIORITY|||||||0.108|||||||t-test, 2 sided|||||||0.108
72567238|NCT01763918|144665491|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-59.23|STANDARD_ERROR_OF_MEAN|2.98|<|0.001|TWO_SIDED|95.0|-65.11|-53.35||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C and ezetimibe use, scheduled visit, and the interaction of treatment with scheduled visit.||Within each dose frequency, the null hypothesis was that there was no mean difference in the percent change from baseline at week 12 or in the percent change from baseline at the mean of weeks 10 and 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.||-53.35|-65.11|<0.001
72483497|NCT01601847|144493928|SUPERIORITY||Odds Ratio (OR)|0.522||||0.0185|TWO_SIDED|95.0|0.304|0.897|||logistic regression with GEE|||||0.897|0.304|0.0185
72483498|NCT01601847|144493929|SUPERIORITY|||||||0.228|||||||Regression, Logistic|||For secondary outcomes, GEE is used to assess randomization arm association.||||0.228
72483499|NCT01601847|144493930|SUPERIORITY|||||||0.798|||||||Regression, Logistic|||||||0.798
72483500|NCT01284062|144493931|SUPERIORITY_OR_OTHER||Least squares (LS) mean|0.41|||||TWO_SIDED|80.0|0.225|0.766|||||LS mean and confidence interval (CI) were based on back log-transformation of those from the analysis of covariance (ANCOVA) model.|||0.766|0.225|
72483501|NCT01284062|144493931|SUPERIORITY_OR_OTHER||LS mean|0.29|||||TWO_SIDED|80.0|0.187|0.446|||||LS mean and CI were based on back log-transformation of those from the ANCOVA model.|||0.446|0.187|
72483502|NCT01284062|144493931|SUPERIORITY_OR_OTHER||LS mean|0.79|||||TWO_SIDED|80.0|0.517|1.203|||||LS mean and CI were based on back log-transformation of those from the ANCOVA model.|||1.203|0.517|
72483503|NCT01284062|144493931|SUPERIORITY_OR_OTHER||LS mean|1.24|||||TWO_SIDED|80.0|0.794|1.949|||||LS mean and CI were based on back log-transformation of those from the ANCOVA model.|||1.949|0.794|
72483504|NCT01284062|144493931|SUPERIORITY_OR_OTHER||LS mean ratio|0.7||||0.532|TWO_SIDED|80.0|0.329|1.472|||ANCOVA||LS mean ratio and CI were based on back log-transformation of those from the ANCOVA model.|P-value was calculated from ANCOVA model with terms for treatment group, baseline (in log scale).||1.472|0.329|0.5320
72483505|NCT01284062|144493931|SUPERIORITY_OR_OTHER||LS mean ratio|1.9||||0.27|TWO_SIDED|80.0|0.9|4.013|||ANCOVA||LS mean ratio and CI were based on back log-transformation of those from the ANCOVA model.|P-value was calculated from ANCOVA model with terms for treatment group, baseline (in log scale).||4.013|0.900|0.2700
72483506|NCT01284062|144493931|SUPERIORITY_OR_OTHER||LS mean ratio|3.0||||0.0666|TWO_SIDED|80.0|1.403|6.409|||ANCOVA||LS mean ratio and CI were based on back log-transformation of those from the ANCOVA model.|P-value was calculated from ANCOVA model with terms for treatment group, baseline (in log scale).||6.409|1.403|0.0666
72483507|NCT01284062|144493938|SUPERIORITY_OR_OTHER||LS mean|0.7|||||TWO_SIDED|80.0|0.466|1.048||||||Week 2: LS mean and CI were based on back log-transformation of those from the ANCOVA model.||1.048|0.466|
72483508|NCT01284062|144493938|SUPERIORITY_OR_OTHER||LS mean|0.81|||||TWO_SIDED|80.0|0.552|1.185||||||Week 2: LS mean and CI were based on back log-transformation of those from the ANCOVA model.||1.185|0.552|
72483509|NCT01284062|144493938|SUPERIORITY_OR_OTHER||LS mean|0.71|||||TWO_SIDED|80.0|0.488|1.027||||||Week 2: LS mean and CI were based on back log-transformation of those from the ANCOVA model.||1.027|0.488|
72483510|NCT01284062|144493938|SUPERIORITY_OR_OTHER||LS mean|0.77|||||TWO_SIDED|80.0|0.5|1.195||||||Week 2: LS mean and CI were based on back log-transformation of those from the ANCOVA model.||1.195|0.500|
72624055|NCT05852470|144778452|SUPERIORITY||Difference in Means|-0.129|STANDARD_ERROR_OF_MEAN|0.0202|<|0.001|TWO_SIDED|95.0|-0.169|-0.089|||t-test, 1 sided||Parameter Dispersion Type is Standard Error of the Difference in Means. Difference = Vivity/Vivity Toric Extended Vision IOL minus Clareon/Clareon Toric Monofocal IOL|||-0.089|-0.169|<.001
72402274|NCT01480076|144311669|SUPERIORITY_OR_OTHER|||||||0.0033|||||||mixed effect model|||Month 12, Responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of the total activity limitation score of PRIMUS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0033
72402275|NCT01480076|144311669|SUPERIORITY_OR_OTHER|||||||0.1758|||||||mixed effect model|||Month 12, Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of the total activity limitation score of PRIMUS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.1758
72402276|NCT01480076|144311669|SUPERIORITY_OR_OTHER||least squares mean|-1.9|STANDARD_ERROR_OF_MEAN|0.84||0.0246|TWO_SIDED||||||mixed effect model|||Month 12, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of the total activity limitation score of PRIMUS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0246
72402277|NCT01480076|144311670|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Overall, Responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of the current health state of EQ-5D scores, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
72402278|NCT01480076|144311670|SUPERIORITY_OR_OTHER|||||||0.0111|||||||mixed effect model|||Overall, Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of the current health state of EQ-5D scores, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0111
72402279|NCT01480076|144311670|SUPERIORITY_OR_OTHER||least squares mean|11.1|STANDARD_ERROR_OF_MEAN|1.61|<|0.0001|TWO_SIDED||||||mixed effect model|||Overall, Responder Versus Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of the current health state of EQ-5D scores, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
72402280|NCT01480076|144311670|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 3, Responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of the current health state of EQ-5D scores, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
72402281|NCT01480076|144311670|SUPERIORITY_OR_OTHER|||||||0.097|||||||mixed effect model|||Month 3, Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of the current health state of EQ-5D scores, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0970
72402282|NCT01480076|144311670|SUPERIORITY_OR_OTHER||least squares mean|11.1|STANDARD_ERROR_OF_MEAN|1.82|<|0.0001|TWO_SIDED||||||mixed effect model|||Month 3, Responder Versus Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of the current health state of EQ-5D scores, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
72483511|NCT01284062|144493938|SUPERIORITY_OR_OTHER||LS mean|0.92|||||TWO_SIDED|80.0|0.631|1.328||||||Week 4: LS mean and CI were based on back log-transformation of those from the ANCOVA model.||1.328|0.631|
72483512|NCT01284062|144493938|SUPERIORITY_OR_OTHER||LS mean|0.47|||||TWO_SIDED|80.0|0.339|0.655||||||Week 4: LS mean and CI were based on back log-transformation of those from the ANCOVA model.||0.655|0.339|
72483513|NCT01284062|144493938|SUPERIORITY_OR_OTHER||LS mean|0.92|||||TWO_SIDED|80.0|0.669|1.269||||||Week 4: LS mean and CI were based on back log-transformation of those from the ANCOVA model.||1.269|0.669|
72483514|NCT01284062|144493938|SUPERIORITY_OR_OTHER||LS mean|0.55|||||TWO_SIDED|80.0|0.388|0.779||||||Week 4: LS mean and CI were based on back log-transformation of those from the ANCOVA model.||0.779|0.388|
72483515|NCT01284062|144493938|SUPERIORITY_OR_OTHER||LS mean|0.78|||||TWO_SIDED|80.0|0.454|1.331||||||Week 8: LS mean and CI were based on back log-transformation of those from the ANCOVA model.||1.331|0.454|
72483516|NCT01284062|144493938|SUPERIORITY_OR_OTHER||LS mean|0.36|||||TWO_SIDED|80.0|0.236|0.553||||||Week 8: LS mean and CI were based on back log-transformation of those from the ANCOVA model.||0.553|0.236|
72483517|NCT01284062|144493938|SUPERIORITY_OR_OTHER||LS mean|1.14|||||TWO_SIDED|80.0|0.757|1.722||||||Week 8: LS mean and CI were based on back log-transformation of those from the ANCOVA model.||1.722|0.757|
72483518|NCT01284062|144493938|SUPERIORITY_OR_OTHER||LS mean|0.52|||||TWO_SIDED|80.0|0.338|0.788||||||Week 8: LS mean and CI were based on back log-transformation of those from the ANCOVA model.||0.788|0.338|
72483519|NCT01284062|144493938|SUPERIORITY_OR_OTHER||LS mean|0.64|||||TWO_SIDED|80.0|0.374|1.084||||||Week 12: LS mean and CI were based on back log-transformation of those from the ANCOVA model.||1.084|0.374|
72483520|NCT01284062|144493938|SUPERIORITY_OR_OTHER||LS mean|0.19|||||TWO_SIDED|80.0|0.122|0.297||||||Week 12: LS mean and CI were based on back log-transformation of those from the ANCOVA model.||0.297|0.122|
72483521|NCT01284062|144493938|SUPERIORITY_OR_OTHER||LS mean|0.96|||||TWO_SIDED|80.0|0.623|1.465||||||Week 12: LS mean and CI were based on back log-transformation of those from the ANCOVA model.||1.465|0.623|
72483522|NCT01284062|144493938|SUPERIORITY_OR_OTHER||LS mean|0.67|||||TWO_SIDED|80.0|0.411|1.076||||||Week 12: LS mean and CI were based on back log-transformation of those from the ANCOVA model.||1.076|0.411|
72567239|NCT01763918|144665491|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-61.27|STANDARD_ERROR_OF_MEAN|3.91|<|0.001|TWO_SIDED|95.0|-69.0|-53.55||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C and ezetimibe use, scheduled visit, and the interaction of treatment with scheduled visit.||Within each dose frequency, the null hypothesis was that there was no mean difference in the percent change from baseline at week 12 or in the percent change from baseline at the mean of weeks 10 and 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.||-53.55|-69.00|<0.001
72567240|NCT01763918|144665492|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-60.15|STANDARD_ERROR_OF_MEAN|2.88|<|0.001|TWO_SIDED|95.0|-65.83|-54.46||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C and ezetimibe use, scheduled visit, and the interaction of treatment with scheduled visit.||Within each dose frequency, the null hypothesis was that there was no mean difference in the percent change from baseline at week 12 or in the percent change from baseline at the mean of weeks 10 and 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.||-54.46|-65.83|<0.001
72567241|NCT01763918|144665492|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-65.55|STANDARD_ERROR_OF_MEAN|2.9|<|0.001|TWO_SIDED|95.0|-71.27|-59.83||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C and ezetimibe use, scheduled visit, and the interaction of treatment with scheduled visit.||Within each dose frequency, the null hypothesis was that there was no mean difference in the percent change from baseline at week 12 or in the percent change from baseline at the mean of weeks 10 and 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.||-59.83|-71.27|<0.001
72567242|NCT01763918|144665493|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-95.2|STANDARD_ERROR_OF_MEAN|5.0|<|0.001|TWO_SIDED|95.0|-105.1|-85.2||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C and ezetimibe use, scheduled visit, and the interaction of treatment with scheduled visit.||||-85.2|-105.1|<0.001
72567243|NCT01763918|144665493|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-97.4|STANDARD_ERROR_OF_MEAN|4.9|<|0.001|TWO_SIDED|95.0|-107.1|-87.7||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C and ezetimibe use, scheduled visit, and the interaction of treatment with scheduled visit.||||-87.7|-107.1|<0.001
72567244|NCT01763918|144665494|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-92.9|STANDARD_ERROR_OF_MEAN|5.1|<|0.001|TWO_SIDED|95.0|-102.9|-82.8||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C and ezetimibe use, scheduled visit, and the interaction of treatment with scheduled visit.||||-82.8|-102.9|<0.001
72567245|NCT01763918|144665494|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-91.3|STANDARD_ERROR_OF_MEAN|6.3|<|0.001|TWO_SIDED|95.0|-103.8|-78.9||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C and ezetimibe use, scheduled visit, and the interaction of treatment with scheduled visit.||||-78.9|-103.8|<0.001
72567246|NCT01763918|144665495|SUPERIORITY_OR_OTHER||Treatment Difference|65.1|||<|0.001|TWO_SIDED|95.0|52.8|73.4||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Cochran-Mantel Haenszel test stratified by baseline LDL-C and ezetimibe use.||||73.4|52.8|<0.001
72567247|NCT01763918|144665495|SUPERIORITY_OR_OTHER||Treatment Difference|78.5|||<|0.001|TWO_SIDED|95.0|66.9|85.1||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Cochran-Mantel Haenszel test stratified by baseline LDL-C and ezetimibe use.||||85.1|66.9|<0.001
72567248|NCT01763918|144665496|SUPERIORITY_OR_OTHER||Treatment Difference|66.3|||<|0.001|TWO_SIDED|95.0|53.7|74.6||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Cochran-Mantel Haenszel test stratified by baseline LDL-C and ezetimibe use||||74.6|53.7|<0.001
72567249|NCT01763918|144665496|SUPERIORITY_OR_OTHER||Treatment Difference|60.9|||<|0.001|TWO_SIDED|95.0|47.6|69.8||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Cochran-Mantel Haenszel test stratified by baseline LDL-C and ezetimibe use.||||69.8|47.6|<0.001
72567250|NCT01763918|144665497|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-56.0|STANDARD_ERROR_OF_MEAN|2.74|<|0.001|TWO_SIDED|95.0|-61.41|-50.59||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C and ezetimibe use, scheduled visit, and the interaction of treatment with scheduled visit.||||-50.59|-61.41|<0.001
72567251|NCT01763918|144665497|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-60.01|STANDARD_ERROR_OF_MEAN|2.65|<|0.001|TWO_SIDED|95.0|-65.24|-54.77||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C and ezetimibe use, scheduled visit, and the interaction of treatment with scheduled visit.||||-54.77|-65.24|<0.001
72624056|NCT05852470|144778453|SUPERIORITY||Difference in Percentages|17.32|||||TWO_SIDED|90.0|8.66||Upper limit is not applicable for testing.|The lower boundary of the confidence interval is reported instead of a p-value.|Miettinen-Nurminen||Difference = Vivity/Vivity Toric Extended Vision IOL minus Clareon/Clareon Toric Monofocal IOL||||8.66|
72624057|NCT01903863|144778454|SUPERIORITY|||||||0.39|||||||Wilcoxon (Mann-Whitney)|||||||0.39
72624058|NCT01903863|144778455|SUPERIORITY|||||||0.07||||||Intracranial hemorrhage|Fisher Exact|||||||0.07
72624059|NCT01903863|144778455|SUPERIORITY|||||||0.7||||||Surgical bleed|Fisher Exact|||||||0.7
72624060|NCT01903863|144778455|SUPERIORITY|||||||0.5||||||Gastrointestinal hemorrhage|Fisher Exact|||||||0.5
72624061|NCT01903863|144778456|SUPERIORITY|||||||0.004|||||||Wilcoxon (Mann-Whitney)|||||||0.004
72483523|NCT01284062|144493938|SUPERIORITY_OR_OTHER||LS mean ratio|1.16||||0.7352|TWO_SIDED|80.0|0.663|2.021|||ANCOVA||LS mean ratio and CI were based on back log-transformation of those from the ANCOVA model.|Week 2: P-value was calculated from ANCOVA model with terms for treatment group, baseline (in log scale).||2.021|0.663|0.7352
72483524|NCT01284062|144493938|SUPERIORITY_OR_OTHER||LS mean ratio|1.01||||0.9754|TWO_SIDED|80.0|0.586|1.753|||ANCOVA||LS mean ratio and CI were based on back log-transformation of those from the ANCOVA model.|Week 2: P-value was calculated from ANCOVA model with terms for treatment group, baseline (in log scale).||1.753|0.586|0.9754
72483525|NCT01284062|144493938|SUPERIORITY_OR_OTHER||LS mean ratio|1.11||||0.8277|TWO_SIDED|80.0|0.609|2.008|||ANCOVA||LS mean ratio and CI were based on back log-transformation of those from the ANCOVA model.|Week 2: P-value was calculated from ANCOVA model with terms for treatment group, baseline (in log scale).||2.008|0.609|0.8277
72483526|NCT01284062|144493938|SUPERIORITY_OR_OTHER||LS mean ratio|0.51||||0.0885|TWO_SIDED|80.0|0.313|0.846|||ANCOVA||LS mean ratio and CI were based on back log-transformation of those from the ANCOVA model.|Week 4: P-value was calculated from ANCOVA model with terms for treatment group, baseline (in log scale).||0.846|0.313|0.0885
72483527|NCT01284062|144493938|SUPERIORITY_OR_OTHER||LS mean ratio|1.01||||0.9856|TWO_SIDED|80.0|0.617|1.644|||ANCOVA||LS mean ratio and CI were based on back log-transformation of those from the ANCOVA model.|Week 4: P-value was calculated from ANCOVA model with terms for treatment group, baseline (in log scale).||1.644|0.617|0.9856
72483528|NCT01284062|144493938|SUPERIORITY_OR_OTHER||LS mean ratio|0.6||||0.1996|TWO_SIDED|80.0|0.361|1.0|||ANCOVA||LS mean ratio and CI were based on back log-transformation of those from the ANCOVA model.|Week 4: P-value was calculated from ANCOVA model with terms for treatment group, baseline (in log scale).||1.000|0.361|0.1996
72483529|NCT01284062|144493938|SUPERIORITY_OR_OTHER||LS mean ratio|0.46||||0.1553|TWO_SIDED|80.0|0.233|0.926|||ANCOVA||LS mean ratio and CI were based on back log-transformation of those from the ANCOVA model.|Week 8: P-value was calculated from ANCOVA model with terms for treatment group, baseline (in log scale).||0.926|0.233|0.1553
72483530|NCT01284062|144493938|SUPERIORITY_OR_OTHER||LS mean ratio|1.47||||0.4633|TWO_SIDED|80.0|0.748|2.882|||ANCOVA||LS mean ratio and CI were based on back log-transformation of those from the ANCOVA model.|Week 8: P-value was calculated from ANCOVA model with terms for treatment group, baseline (in log scale).||2.882|0.748|0.4633
72483531|NCT01284062|144493938|SUPERIORITY_OR_OTHER||LS mean ratio|0.66||||0.4409|TWO_SIDED|80.0|0.335|1.316|||ANCOVA||LS mean ratio and CI were based on back log-transformation of those from the ANCOVA model.|Week 8: P-value was calculated from ANCOVA model with terms for treatment group, baseline (in log scale).||1.316|0.335|0.4409
72483532|NCT01284062|144493938|SUPERIORITY_OR_OTHER||LS mean ratio|0.3||||0.0283|TWO_SIDED|80.0|0.15|0.598|||ANCOVA||LS mean ratio and CI were based on back log-transformation of those from the ANCOVA model.|Week 12: P-value was calculated from ANCOVA model with terms for treatment group, baseline (in log scale).||0.598|0.150|0.0283
72511949|NCT04149899|144553964|OTHER|The null hypothesis is that the mean change from Baseline, Hour 2 = 0 at Day 14, Hour 2.|Mean Difference (Net)|-5.1|STANDARD_DEVIATION|2.51|<|0.001|TWO_SIDED|95.0|-6.14|-4.02||The p-value was not adjusted for multiple comparisons.|t-test, 2 sided|||A within-group comparison was performed between Baseline, Hour 2 and Day 14, Hour 2, the timepoint for the peak effect of Timolol 0.5%.||-4.02|-6.14|<0.001
72511950|NCT04149899|144553964|OTHER|The null hypothesis is that the mean change from Baseline, Hour 2 = 0 at Day 14, Hour 2.|Mean Difference (Net)|-6.0|STANDARD_DEVIATION|3.05|<|0.001|TWO_SIDED|95.0|-7.93|-4.07||The p-value was not adjusted for multiple comparisons.|t-test, 2 sided|||A within-group comparison was performed between Baseline, Hour 2 and Day 14, Hour 2, the timepoint for the peak effect of Timolol 0.5%.||-4.07|-7.93|<0.001
72567252|NCT01763918|144665498|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-54.79|STANDARD_ERROR_OF_MEAN|2.87|<|0.001|TWO_SIDED|95.0|-60.47|-49.12||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C and ezetimibe use, scheduled visit, and the interaction of treatment with scheduled visit.||||-49.12|-60.47|<0.001
72483533|NCT01284062|144493938|SUPERIORITY_OR_OTHER||LS mean ratio|1.5||||0.4434|TWO_SIDED|80.0|0.758|2.97|||ANCOVA||LS mean ratio and CI were based on back log-transformation of those from the ANCOVA model.|Week 12: P-value was calculated from ANCOVA model with terms for treatment group, baseline (in log scale).||2.970|0.758|0.4434
72483534|NCT01284062|144493938|SUPERIORITY_OR_OTHER||LS mean ratio|1.04||||0.9372|TWO_SIDED|80.0|0.51|2.141|||ANCOVA||LS mean ratio and CI were based on back log-transformation of those from the ANCOVA model.|Week 12: P-value was calculated from ANCOVA model with terms for treatment group, baseline (in log scale).||2.141|0.510|0.9372
72567253|NCT01763918|144665498|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-54.95|STANDARD_ERROR_OF_MEAN|3.54|<|0.001|TWO_SIDED|95.0|-61.95|-47.96||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C and ezetimibe use, scheduled visit, and the interaction of treatment with scheduled visit.||||-47.96|-61.95|<0.001
72624062|NCT01903863|144778457|SUPERIORITY|||||||0.8|||||||Wilcoxon (Mann-Whitney)|||||||0.8
72624063|NCT01903863|144778458|SUPERIORITY|||||||0.37|||||||Wilcoxon (Mann-Whitney)|||||||0.37
72483535|NCT01284062|144493943|SUPERIORITY_OR_OTHER||percentage of participants|41.67|||||TWO_SIDED|80.0|25.53|59.81|||||CI was assessed by Wilson score method.|||59.81|25.53|
72483536|NCT01284062|144493943|SUPERIORITY_OR_OTHER||percentage of participants|60.0|||||TWO_SIDED|80.0|43.59|74.43|||||CI was assessed by Wilson score method.|||74.43|43.59|
72483537|NCT01284062|144493943|SUPERIORITY_OR_OTHER||percentage of participants|50.0|||||TWO_SIDED|80.0|34.74|65.26|||||CI was assessed by Wilson score method.|||65.26|34.74|
72483538|NCT01284062|144493943|SUPERIORITY_OR_OTHER||percentage of participants|15.38|||||TWO_SIDED|80.0|6.58|31.96|||||CI was assessed by Wilson score method.|||31.96|6.58|
72483539|NCT01284062|144493943|SUPERIORITY_OR_OTHER||percent difference|18.33||||0.4495|TWO_SIDED|80.0|-6.13|39.98|||Fisher Exact||CI was assessed by Wilson score method.|Two-sided p-value was calculated by Fisher's exact test.||39.98|-6.13|0.4495
72483540|NCT01284062|144493943|SUPERIORITY_OR_OTHER||percent difference|8.33||||0.7177|TWO_SIDED|80.0|-15.37|30.54|||Fisher Exact||CI was assessed by Wilson score method.|Two-sided p-value was calculated by Fisher's exact test.||30.54|-15.37|0.7177
72483541|NCT01284062|144493943|SUPERIORITY_OR_OTHER||percent difference|-26.28||||0.2016|TWO_SIDED|80.0|-46.45|-3.15|||Fisher Exact||CI was assessed by Wilson score method.|Two-sided p-value was calculated by Fisher's exact test.||-3.15|-46.45|0.2016
72483542|NCT01284062|144493944|SUPERIORITY_OR_OTHER||percentage of participants|16.67|||||TWO_SIDED|80.0|7.14|34.22|||||CI was assessed by Wilson score method.|||34.22|7.14|
72483543|NCT01284062|144493944|SUPERIORITY_OR_OTHER||percentage of participants|33.33|||||TWO_SIDED|80.0|20.08|49.88|||||CI was assessed by Wilson score method.|||49.88|20.08|
72483544|NCT01284062|144493944|SUPERIORITY_OR_OTHER||percentage of participants|18.75|||||TWO_SIDED|80.0|9.4|33.92|||||CI was assessed by Wilson score method.|||33.92|9.40|
72483545|NCT01284062|144493944|SUPERIORITY_OR_OTHER||percentage of participants|0.0|||||TWO_SIDED|80.0|0.0|11.22|||||CI was assessed by Wilson score method.|||11.22|0.00|
72483546|NCT01284062|144493944|SUPERIORITY_OR_OTHER||percent difference|16.67||||0.4082|TWO_SIDED|80.0|-5.33|35.76|||Fisher Exact||CI was assessed by Wilson score method.|Two-sided p-value was calculated by Fisher's exact test.||35.76|-5.33|0.4082
72483547|NCT01284062|144493944|SUPERIORITY_OR_OTHER||percent difference|2.08||||1|TWO_SIDED|80.0|-17.8|19.99|||Fisher Exact||CI was assessed by Wilson score method.|Two-sided p-value was calculated by Fisher's exact test.||19.99|-17.80|1.0000
72483548|NCT01284062|144493944|SUPERIORITY_OR_OTHER||percent difference|-16.67||||0.22|TWO_SIDED|80.0|-34.22|-1.95|||Fisher Exact||CI was assessed by Wilson score method.|Two-sided p-value was calculated by Fisher's exact test.||-1.95|-34.22|0.2200
72483549|NCT01284062|144493945|SUPERIORITY_OR_OTHER||LS mean|-1.32|||||TWO_SIDED|80.0|-2.332|-0.3||||||||-0.300|-2.332|
72483550|NCT01284062|144493945|SUPERIORITY_OR_OTHER||LS mean|-2.28|||||TWO_SIDED|80.0|-3.19|-1.374||||||||-1.374|-3.190|
72511951|NCT04149899|144553964|NON_INFERIORITY|A pairwise treatment group comparison was performed versus timolol ophthalmic solution 0.5%. A 2-sided 95% confidence interval (CI) for the treatment difference (WB007 minus Timolol) was constructed based on an ANCOVA model. If WB007 was determined to be non-inferior to Timolol, an attempt to show superiority of WB007 over Timolol was made.|Mean Difference (Net)|0.14||||0.828|TWO_SIDED|95.0|-1.16|1.43||The p-value (2-sided) for superiority was not adjusted for multiple comparisons.|ANCOVA|The ANCOVA model used the Baseline IOP values at Hour 2 as the covariate.|The estimated treatment difference is based on the least-square means from the ANCOVA model.|The mean IOP change from Baseline, Hour 2 to Day 14, Hour 2 (the timepoint for the peak effect of Timolol 0.5%) was compared between WB007 0.15% and Timolol 0.5%.||1.43|-1.16|0.828
72567254|NCT01763918|144665499|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-49.39|STANDARD_ERROR_OF_MEAN|2.5|<|0.001|TWO_SIDED|95.0|-54.32|-44.46||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C and ezetimibe use, scheduled visit, and the interaction of treatment with scheduled visit.||||-44.46|-54.32|<0.001
72567255|NCT01763918|144665499|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-54.98|STANDARD_ERROR_OF_MEAN|2.33|<|0.001|TWO_SIDED|95.0|-59.58|-50.38||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C and ezetimibe use, scheduled visit, and the interaction of treatment with scheduled visit.||||-50.38|-59.58|<0.001
72624064|NCT01903863|144778459|SUPERIORITY|||||||0.8|||||||Wilcoxon (Mann-Whitney)|||||||0.8
72483551|NCT01284062|144493945|SUPERIORITY_OR_OTHER||LS mean|-2.3|||||TWO_SIDED|80.0|-3.178|-1.419||||||||-1.419|-3.178|
72483552|NCT01284062|144493945|SUPERIORITY_OR_OTHER||LS mean|-0.79|||||TWO_SIDED|80.0|-1.761|0.19||||||||0.190|-1.761|
72483553|NCT01284062|144493945|SUPERIORITY_OR_OTHER||LS mean difference|-0.97||||0.3639|TWO_SIDED|80.0|-2.335|0.403|||ANCOVA|||P-value was analyzed from ANCOVA model with terms for treatment group and baseline.||0.403|-2.335|0.3639
72624065|NCT01903863|144778460|SUPERIORITY|||||||0.12|||||||Wilcoxon (Mann-Whitney)|||||||0.12
72624066|NCT01903863|144778461|SUPERIORITY|||||||0.95|||||||Wilcoxon (Mann-Whitney)|||||||0.95
72483554|NCT01284062|144493945|SUPERIORITY_OR_OTHER||LS mean difference|-0.98||||0.3446|TWO_SIDED|80.0|-2.32|0.355|||ANCOVA|||P-value was analyzed from ANCOVA model with terms for treatment group and baseline.||0.355|-2.320|0.3446
72483555|NCT01284062|144493945|SUPERIORITY_OR_OTHER||LS mean difference|0.53||||0.6285|TWO_SIDED|80.0|-0.884|1.945|||ANCOVA|||P-value was analyzed from ANCOVA model with terms for treatment group and baseline.||1.945|-0.884|0.6285
72483556|NCT00809523|144494053|SUPERIORITY_OR_OTHER|||||||0.007||95.0|||||t-test, 2 sided|||Data were analyzed at the follow up timepoint (4 weeks) to test for differences between the experimental groups.||||0.007
72483557|NCT00809523|144494054|SUPERIORITY_OR_OTHER|||||||0.014||95.0|||||t-test, 2 sided|||||||0.014
72483558|NCT04721821|144494066|SUPERIORITY||Odds Ratio (OR)|1.09|||||TWO_SIDED|95.0|0.82|1.44||||||||1.44|0.82|
72483559|NCT04721821|144494067|SUPERIORITY||Odds Ratio (OR)|0.72|||||TWO_SIDED|95.0|0.44|1.16||||||||1.16|0.44|
72483560|NCT04721821|144494068|SUPERIORITY||Odds Ratio (OR)|0.96|||||TWO_SIDED|95.0|0.73|1.27||||||||1.27|0.73|
72483561|NCT04721821|144494069|SUPERIORITY||Odds Ratio (OR)|1.22|||||TWO_SIDED|95.0|0.79|1.88||||||||1.88|0.79|
72483562|NCT04721821|144494070|SUPERIORITY||Odds Ratio (OR)|1.14|||||TWO_SIDED|95.0|0.79|1.67||||||||1.67|0.79|
72483563|NCT04721821|144494071|SUPERIORITY||Odds Ratio (OR)|1.29|||||TWO_SIDED|95.0|0.94|1.76||||||||1.76|0.94|
72483564|NCT04721821|144494072|SUPERIORITY||Odds Ratio (OR)|1.15|||||TWO_SIDED|95.0|0.7|1.89||||||||1.89|0.70|
72483565|NCT04721821|144494073|SUPERIORITY||Odds Ratio (OR)|0.96|||||TWO_SIDED|95.0|0.69|1.32||||||||1.32|0.69|
72483566|NCT04721821|144494074|SUPERIORITY||Odds Ratio (OR)|1.33|||||TWO_SIDED|95.0|0.81|2.16||||||||2.16|0.81|
72483567|NCT04721821|144494075|SUPERIORITY||Odds Ratio (OR)|1.23|||||TWO_SIDED|95.0|0.81|1.87||||||||1.87|0.81|
72483568|NCT04721821|144494076|SUPERIORITY||Odds Ratio (OR)|1.16|||||TWO_SIDED|95.0|0.8|1.66||||||Month 6 follow-up visit analysis||1.66|0.80|
72483569|NCT04721821|144494076|SUPERIORITY||Odds Ratio (OR)|1.11|||||TWO_SIDED|95.0|0.75|1.65||||||Month 12 follow-up visit analysis||1.65|0.75|
72483570|NCT04721821|144494077|SUPERIORITY||Odds Ratio (OR)|1.06|||||TWO_SIDED|95.0|0.57|1.99||||||Month 6 follow-up visit analysis||1.99|0.57|
72483571|NCT04721821|144494077|SUPERIORITY||Odds Ratio (OR)|0.92|||||TWO_SIDED|95.0|0.49|1.75||||||Month 12 follow-up visit analysis||1.75|0.49|
72483572|NCT04721821|144494078|SUPERIORITY||Odds Ratio (OR)|1.12|||||TWO_SIDED|95.0|0.79|1.58||||||Month 6 follow-up visit analysis||1.58|0.79|
72483573|NCT04721821|144494078|SUPERIORITY||Odds Ratio (OR)|0.9|||||TWO_SIDED|95.0|0.6|1.35||||||Month 12 follow-up visit analysis||1.35|0.60|
72483574|NCT04721821|144494079|SUPERIORITY||Odds Ratio (OR)|1.33|||||TWO_SIDED|95.0|0.77|2.29||||||Month 6 follow-up visit analysis||2.29|0.77|
72483575|NCT04721821|144494079|SUPERIORITY||Odds Ratio (OR)|1.49|||||TWO_SIDED|95.0|0.82|2.71||||||Month 12 follow-up visit analysis||2.71|0.82|
72483576|NCT04721821|144494080|SUPERIORITY||Odds Ratio (OR)|1.35|||||TWO_SIDED|95.0|0.81|2.24||||||Month 6 follow-up visit analysis||2.24|0.81|
72483577|NCT04721821|144494080|SUPERIORITY||Odds Ratio (OR)|0.9|||||TWO_SIDED|95.0|0.5|1.62||||||Month 12 follow-up visit analysis||1.62|0.50|
72483578|NCT04721821|144494081|SUPERIORITY||Mean Difference (Net)|0.21|||||TWO_SIDED|95.0|-0.88|1.31||||||Month 6 follow-up visit analysis||1.31|-0.88|
72483579|NCT04721821|144494081|SUPERIORITY||Mean Difference (Net)|-1.5|||||TWO_SIDED|95.0|-2.73|-0.27||||||Month 12 follow-up visit analysis||-0.27|-2.73|
72483580|NCT04721821|144494082|SUPERIORITY||Median Difference (Net)|0.39|||||TWO_SIDED|95.0|-1.24|2.02||||||Month 6 follow-up visit analysis||2.02|-1.24|
72511952|NCT04149899|144553964|NON_INFERIORITY|A pairwise treatment group comparison was performed versus timolol ophthalmic solution 0.5%. A 2-sided 95% confidence interval (CI) for the treatment difference (WB007 minus Timolol) was constructed based on an ANCOVA model. If WB007 was determined to be non-inferior to Timolol, an attempt to show superiority of WB007 over Timolol was made.|Mean Difference (Net)|-0.42||||0.52|TWO_SIDED|95.0|-1.73|0.89||The p-value (2-sided) for superiority was not adjusted for multiple comparisons.|ANCOVA|The ANCOVA model used the Baseline IOP values at Hour 2 as the covariate.|The estimated treatment difference is based on the least-square means from the ANCOVA model.|The mean IOP change from Baseline, Hour 2 to Day 14, Hour 2 (the timepoint for the peak effect of Timolol 0.5%) was compared between WB007 0.4% and Timolol 0.5%.||0.89|-1.73|0.520
72511953|NCT04149899|144553965|NON_INFERIORITY|A pairwise treatment group comparison was performed versus timolol ophthalmic solution 0.5%. A 2-sided 95% confidence interval (CI) for the treatment difference (WB007 minus Timolol) was constructed based on an ANCOVA model. If WB007 was determined to be non-inferior to Timolol, an attempt to show superiority of WB007 over Timolol was made.|Mean Difference (Final Values)|0.14||||0.828|TWO_SIDED|95.0|-1.16|1.43||The p-value (2-sided) for superiority was not adjusted for multiple comparisons.|ANCOVA||The estimated treatment difference is based on the least-square means from the ANCOVA model.|The mean IOP for WB007 0.15% was compared to Timolol 0.5% at Day 14, Hour 2, the timepoint for the peak effect of Timolol 0.5% and the primary efficacy timepoint for the study.||1.43|-1.16|0.828
72511954|NCT04149899|144553965|NON_INFERIORITY|A pairwise treatment group comparison was performed versus timolol ophthalmic solution 0.5%. A 2-sided 95% confidence interval (CI) for the treatment difference (WB007 minus Timolol) was constructed based on an ANCOVA model. If WB007 was determined to be non-inferior to Timolol, an attempt to show superiority of WB007 over Timolol was made.|Mean Difference (Final Values)|-0.42||||0.52|TWO_SIDED|95.0|-1.73|0.89||The p-value (2-sided) for superiority was not adjusted for multiple comparisons.|ANCOVA||The estimated treatment difference is based on the least-square means from the ANCOVA model.|The mean IOP for WB007 0.4% was compared to Timolol 0.5% at Day 14, Hour 2, the timepoint for the peak effect of Timolol 0.5% and the primary efficacy timepoint for the study.||0.89|-1.73|0.520
72567256|NCT01763918|144665500|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-49.09|STANDARD_ERROR_OF_MEAN|2.76|<|0.001|TWO_SIDED|95.0|-54.55|-43.63||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C and ezetimibe use, scheduled visit, and the interaction of treatment with scheduled visit.||||-43.63|-54.55|<0.001
72567257|NCT01763918|144665500|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-49.41|STANDARD_ERROR_OF_MEAN|3.19|<|0.001|TWO_SIDED|95.0|-55.73|-43.1||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C and ezetimibe use, scheduled visit, and the interaction of treatment with scheduled visit.||||-43.10|-55.73|<0.001
72483581|NCT04721821|144494082|SUPERIORITY||Median Difference (Net)|0.96|||||TWO_SIDED|95.0|-0.92|2.84||||||Month 12 follow-up visit analysis||2.84|-0.92|
72483582|NCT04721821|144494083|SUPERIORITY||Mean Difference (Net)|-0.56|||||TWO_SIDED|95.0|-1.68|0.56||||||Month 6 follow-up visit analysis||0.56|-1.68|
72483583|NCT04721821|144494083|SUPERIORITY||Mean Difference (Net)|0.74|||||TWO_SIDED|95.0|-0.51|1.99||||||Month 12 follow-up visit analysis||1.99|-0.51|
72483584|NCT04721821|144494084|SUPERIORITY||Mean Difference (Net)|-1.11|||||TWO_SIDED|95.0|-2.66|0.45||||||Month 6 follow-up visit analysis||0.45|-2.66|
72483585|NCT04721821|144494084|SUPERIORITY||Mean Difference (Net)|-1.73|||||TWO_SIDED|95.0|-3.52|0.05||||||Month 12 follow-up visit analysis||0.05|-3.52|
72483586|NCT04721821|144494085|SUPERIORITY||Mean Difference (Net)|-0.93|||||TWO_SIDED|95.0|-2.3|0.44||||||Month 6 follow-up visit analysis||0.44|-2.30|
72483587|NCT04721821|144494085|SUPERIORITY||Mean Difference (Net)|-0.99|||||TWO_SIDED|95.0|-2.6|0.62||||||Month 12 follow-up visit analysis||0.62|-2.60|
72483588|NCT04721821|144494086|SUPERIORITY||Odds Ratio (OR)|1.04|||||TWO_SIDED|95.0|0.8|1.35||||||Month 6 follow-up visit analysis: mACR 20||1.35|0.80|
72483589|NCT04721821|144494086|SUPERIORITY||Odds Ratio (OR)|1.2|||||TWO_SIDED|95.0|0.86|1.67||||||Month 6 follow-up visit analysis: mACR 50||1.67|0.86|
72483590|NCT04721821|144494086|SUPERIORITY||Odds Ratio (OR)|0.93|||||TWO_SIDED|95.0|0.57|1.54||||||Month 6 follow-up visit analysis: mACR 70||1.54|0.57|
72483591|NCT04721821|144494086|SUPERIORITY||Odds Ratio (OR)|1.04|||||TWO_SIDED|95.0|0.77|1.41||||||Month 12 follow-up visit analysis: mACR 20||1.41|0.77|
72483592|NCT04721821|144494086|SUPERIORITY||Odds Ratio (OR)|1.32|||||TWO_SIDED|95.0|0.89|1.95||||||Month 12 follow-up visit analysis: mACR 50||1.95|0.89|
72483593|NCT04721821|144494086|SUPERIORITY||Odds Ratio (OR)|1.49|||||TWO_SIDED|95.0|0.85|2.6||||||Month 12 follow-up visit analysis: mACR 70||2.60|0.85|
72483594|NCT04721821|144494087|SUPERIORITY||Odds Ratio (OR)|0.88|||||TWO_SIDED|95.0|0.59|1.34||||||Month 6 follow-up visit analysis: mACR 20||1.34|0.59|
72483595|NCT04721821|144494087|SUPERIORITY||Odds Ratio (OR)|0.67|||||TWO_SIDED|95.0|0.39|1.15||||||Month 6 follow-up visit analysis: mACR 50||1.15|0.39|
72483596|NCT04721821|144494087|SUPERIORITY||Odds Ratio (OR)|0.79|||||TWO_SIDED|95.0|0.34|1.83||||||Month 6 follow-up visit analysis: mACR 70||1.83|0.34|
72483597|NCT04721821|144494087|SUPERIORITY||Odds Ratio (OR)|0.89|||||TWO_SIDED|95.0|0.56|1.42||||||Month 12 follow-up visit analysis: mACR 20||1.42|0.56|
72483598|NCT04721821|144494087|SUPERIORITY||Odds Ratio (OR)|0.91|||||TWO_SIDED|95.0|0.46|1.8||||||Month 12 follow-up visit analysis: mACR 50||1.80|0.46|
72483599|NCT04721821|144494087|SUPERIORITY||Odds Ratio (OR)|0.54|||||TWO_SIDED|95.0|0.19|1.48||||||Month 12 follow-up visit analysis: mACR 70||1.48|0.19|
72483600|NCT04721821|144494088|SUPERIORITY||Odds Ratio (OR)|1.11|||||TWO_SIDED|95.0|0.86|1.45||||||Month 6 follow-up visit analysis: mACR 20||1.45|0.86|
72483601|NCT04721821|144494088|SUPERIORITY||Odds Ratio (OR)|0.92|||||TWO_SIDED|95.0|0.67|1.26||||||Month 6 follow-up visit analysis: mACR 50||1.26|0.67|
72483602|NCT04721821|144494088|SUPERIORITY||Odds Ratio (OR)|0.69|||||TWO_SIDED|95.0|0.44|1.09||||||Month 6 follow-up visit analysis: mACR 70||1.09|0.44|
72483603|NCT04721821|144494088|SUPERIORITY||Odds Ratio (OR)|1.01|||||TWO_SIDED|95.0|0.74|1.38||||||Month 12 follow-up visit analysis: mACR 20||1.38|0.74|
72483604|NCT04721821|144494088|SUPERIORITY||Odds Ratio (OR)|1.03|||||TWO_SIDED|95.0|0.69|1.52||||||Month 12 follow-up visit analysis: mACR 50||1.52|0.69|
72511955|NCT04149899|144553965|NON_INFERIORITY|A pairwise treatment group comparison was performed versus timolol ophthalmic solution 0.5%. A 2-sided 95% confidence interval (CI) for the treatment difference (WB007 minus Timolol) was constructed based on an ANOVA model. If WB007 was determined to be non-inferior to Timolol, an attempt to show superiority of WB007 over Timolol was made.|Mean Difference (Final Values)|-0.84||||0.283|TWO_SIDED|95.0|-2.39|0.71||The p-value (2-sided) for superiority was not adjusted for multiple comparisons.|ANOVA|The ANOVA model has the treatment group as the main effect.|The estimated treatment difference is based on the least-square means from the ANOVA model.|The mean IOP for WB007 0.15% was compared to Timolol 0.5% at Day 14, Hour 2, the timepoint for the peak effect of Timolol 0.5% and the primary efficacy timepoint for the study.||0.71|-2.39|0.283
72511956|NCT04149899|144553965|NON_INFERIORITY|A pairwise treatment group comparison was performed versus timolol ophthalmic solution 0.5%. A 2-sided 95% confidence interval (CI) for the treatment difference (WB007 minus Timolol) was constructed based on an ANOVA model. If WB007 was determined to be non-inferior to Timolol, an attempt to show superiority of WB007 over Timolol was made.|Mean Difference (Final Values)|-1.02||||0.189|TWO_SIDED|95.0|-2.56|0.52||The p-value (2-sided) for superiority was not adjusted for multiple comparisons.|ANOVA|The ANOVA model has the treatment group as the main effect.|The estimated treatment difference is based on the least-square means from the ANOVA model.|The mean IOP for WB007 0.4% was compared to Timolol 0.5% at Day 14, Hour 2, the timepoint for the peak effect of Timolol 0.5% and the primary efficacy timepoint for the study.||0.52|-2.56|0.189
72511957|NCT01773135|144553981|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||U statistic|||||||<0.001
72511958|NCT02913222|144553982|OTHER|||||||1||||||The threshold for statistical significance was set at p = 0.05.|Fisher Exact|||A priori criteria for success was that we would achieve 90% adherence to attending treatment sessions. Fisher's exact test compared patient adherence to treatment session rates by site and by group.||||1.0
72511959|NCT02913222|144553983|OTHER|The purpose of this study was to determine preliminary estimates of the effect of movement pattern training and standard rehabilitation on patient-reported function.|Mean Difference (Final Values)|-2.2||||0.32|TWO_SIDED|95.0|-6.51|2.11||The threshold for statistical significance was p = 0.05|ANCOVA|||We hypothesized MPT would demonstrate greater improvement in HOOS compared to Standard. Data collected at pretest and posttest were analyzed with ANCOVA where posttest was the dependent variable, pretest was the covariate, and treatment group was the independent variable which tests the null hypothesis that after adjusting for pretest, posttest is not significantly different across treatment groups.||2.11|-6.51|0.32
72402283|NCT01480076|144311670|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 6, Responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of the current health state of EQ-5D scores, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
72483605|NCT04721821|144494088|SUPERIORITY||Odds Ratio (OR)|0.78|||||TWO_SIDED|95.0|0.46|1.33||||||Month 12 follow-up visit analysis: mACR 70||1.33|0.46|
72483606|NCT04721821|144494089|SUPERIORITY||Odds Ratio (OR)|1.18|||||TWO_SIDED|95.0|0.78|1.77||||||Month 6 follow-up visit analysis: mACR 20||1.77|0.78|
72483607|NCT04721821|144494089|SUPERIORITY||Odds Ratio (OR)|1.17|||||TWO_SIDED|95.0|0.71|1.95||||||Month 6 follow-up visit analysis: mACR 50||1.95|0.71|
72483608|NCT04721821|144494089|SUPERIORITY||Odds Ratio (OR)|1.04|||||TWO_SIDED|95.0|0.45|2.39||||||Month 6 follow-up visit analysis: mACR 70||2.39|0.45|
72483609|NCT04721821|144494089|SUPERIORITY||Odds Ratio (OR)|0.84|||||TWO_SIDED|95.0|0.5|1.4||||||Month 12 follow-up visit analysis: mACR 20||1.40|0.50|
72483610|NCT04721821|144494089|SUPERIORITY||Odds Ratio (OR)|0.95|||||TWO_SIDED|95.0|0.49|1.83||||||Month 12 follow-up visit analysis: mACR 50||1.83|0.49|
72483611|NCT04721821|144494089|SUPERIORITY||Odds Ratio (OR)|0.8|||||TWO_SIDED|95.0|0.33|1.95||||||Month 12 follow-up visit analysis: mACR 70||1.95|0.33|
72483612|NCT04721821|144494090|SUPERIORITY||Odds Ratio (OR)|1.07|||||TWO_SIDED|95.0|0.76|1.49||||||Month 6 follow-up visit analysis: mACR 20||1.49|0.76|
72483613|NCT04721821|144494090|SUPERIORITY||Odds Ratio (OR)|0.87|||||TWO_SIDED|95.0|0.55|1.37||||||Month 6 follow-up visit analysis: mACR 50||1.37|0.55|
72483614|NCT04721821|144494090|SUPERIORITY||Odds Ratio (OR)|0.62|||||TWO_SIDED|95.0|0.32|1.2||||||Month 6 follow-up visit analysis: mACR 70||1.20|0.32|
72483615|NCT04721821|144494090|SUPERIORITY||Odds Ratio (OR)|0.88|||||TWO_SIDED|95.0|0.59|1.3||||||Month 12 follow-up visit analysis: mACR 20||1.30|0.59|
72483616|NCT04721821|144494090|SUPERIORITY||Odds Ratio (OR)|1.1|||||TWO_SIDED|95.0|0.65|1.86||||||Month 12 follow-up visit analysis: mACR 50||1.86|0.65|
72483617|NCT04721821|144494090|SUPERIORITY||Odds Ratio (OR)|1.43||||||95.0|0.62|3.28||||||Month 12 follow-up visit analysis: mACR 70||3.28|0.62|
72483618|NCT04721821|144494091|SUPERIORITY||Odds Ratio (OR)|1.42|||||TWO_SIDED|95.0|0.94|2.15||||||Month 6 follow-up visit analysis||2.15|0.94|
72483619|NCT04721821|144494091|SUPERIORITY||Odds Ratio (OR)|1.12|||||TWO_SIDED|95.0|0.68|1.84||||||Month 12 follow-up visit analysis||1.84|0.68|
72483620|NCT04721821|144494092|SUPERIORITY||Odds Ratio (OR)|0.82|||||TWO_SIDED|95.0|0.41|1.67||||||Month 6 follow-up visit analysis||1.67|0.41|
72483621|NCT04721821|144494092|SUPERIORITY||Odds Ratio (OR)|1.38|||||TWO_SIDED|95.0|0.62|3.07||||||Month 12 follow-up visit analysis||3.07|0.62|
72483622|NCT04721821|144494093|SUPERIORITY||Odds Ratio (OR)|1.0|||||TWO_SIDED|95.0|0.66|1.52||||||Month 6 follow-up visit analysis||1.52|0.66|
72483623|NCT04721821|144494093|SUPERIORITY||Odds Ratio (OR)|1.05|||||TWO_SIDED|95.0|0.64|1.74||||||Month 12 follow-up visit analysis||1.74|0.64|
72483624|NCT04721821|144494094|SUPERIORITY||Odds Ratio (OR)|1.54|||||TWO_SIDED|95.0|0.8|2.94||||||Month 6 follow-up visit analysis||2.94|0.80|
72483625|NCT04721821|144494094|SUPERIORITY||Odds Ratio (OR)|1.72|||||TWO_SIDED|95.0|0.76|3.87||||||Month 12 follow-up visit analysis||3.87|0.76|
72483626|NCT04721821|144494095|SUPERIORITY||Odds Ratio (OR)|1.29|||||TWO_SIDED|95.0|0.73|2.27||||||Month 6 follow-up visit analysis||2.27|0.73|
72483627|NCT04721821|144494095|SUPERIORITY||Odds Ratio (OR)|1.18|||||TWO_SIDED|95.0|0.63|2.23||||||Month 12 follow-up visit analysis||2.23|0.63|
72483628|NCT04721821|144494096|SUPERIORITY||Mean Difference (Final Values)|-0.01|||||TWO_SIDED|95.0|-0.06|0.04||||||Month 6 follow-up visit analysis||0.04|-0.06|
72483629|NCT04721821|144494096|SUPERIORITY||Mean Difference (Final Values)|0.04|||||TWO_SIDED|95.0|-0.01|0.09||||||Month 12 follow-up visit analysis||0.09|-0.01|
72511960|NCT02913222|144553984|OTHER|The purpose of this study was to determine preliminary estimates of the effect of movement pattern training and standard rehabilitation on patient-reported function.|Mean Difference (Final Values)|-5.55||||0.14|TWO_SIDED|95.0|-13.1|1.99||The threshold for statistical significance was p = 0.05.|ANCOVA|||We hypothesized MPT would demonstrate greater improvement in HOOS compared to Standard. Data collected at pretest and posttest were analyzed with ANCOVA where posttest was the dependent variable, pretest was the covariate, and treatment group was the independent variable which tests the null hypothesis that after adjusting for pretest, posttest is not significantly different across treatment groups.||1.99|-13.10|0.14
72511961|NCT02371759|144554061|NON_INFERIORITY_OR_EQUIVALENCE|In order to detect 20% difference in intraoral anesthesia duration between healthy and diabetic participants, with 80 % statistical power at a two-tailed significance level of 0.05 using Mann Whitney U test, it was calculated that at least 24 participants must be included in each group|||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||In order to detect 20% difference in intraoral anesthesia duration between healthy and diabetic participants, with 80 % statistical power at a two-tailed significance level of 0.05 using Mann Whitney U test, it was calculated that at least 24 participants must be included in each group||||<0.05
72511962|NCT02371759|144554062|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Chi-squared|||||||<0.05
72511963|NCT02371759|144554078|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Chi-squared|||||||<0.05
72511964|NCT02371759|144554079|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Chi-squared|||||||<0.05
72511965|NCT02371759|144554080|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Chi-squared|||||||<0.05
72511966|NCT02371759|144554081|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Chi-squared|||||||<0.05
72511967|NCT02371759|144554082|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
72483630|NCT04721821|144494097|SUPERIORITY||Mean Difference (Final Values)|-0.01|||||TWO_SIDED|95.0|-0.08|0.06||||||Month 6 follow-up visit analysis||0.06|-0.08|
72511968|NCT02371759|144554083|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
72511969|NCT02371759|144554084|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Chi-squared|||||||<0.05
72511970|NCT02371759|144554085|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Chi-squared|||||||<0.05
72483631|NCT04721821|144494097|SUPERIORITY||Median Difference (Final Values)|-0.03|||||TWO_SIDED|95.0|-0.11|0.05||||||Month 12 follow-up visit analysis||0.05|-0.11|
72483632|NCT04721821|144494098|SUPERIORITY||Mean Difference (Final Values)|-0.02|||||TWO_SIDED|95.0|-0.07|0.03||||||Month 6 follow-up visit analysis||0.03|-0.07|
72483633|NCT04721821|144494098|SUPERIORITY||Odds Ratio (OR)|0.01|||||TWO_SIDED|95.0|-0.05|0.07||||||Month 12 follow-up visit analysis||0.07|-0.05|
72511971|NCT00430625|144554086|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.429|STANDARD_ERROR_OF_MEAN|0.324|<|0.0001|TWO_SIDED|95.0|1.717|3.141|||paired t-test|||Primary endpoint was based solely on the 60 U/kg treatment arm||3.141|1.717|<0.0001
72511972|NCT00243230|144554093|SUPERIORITY||VCV 30 mg vs. Placebo|-0.98||||0.0017|TWO_SIDED|95.0|-1.58|-0.37|||ANOVA|ANOVA model adjusted for treatment and stratification factors - the use of T20 in current OBT and the baseline HIV-1 RNA ≤100,000 copies/mL.||||-0.37|-1.58|0.0017
72483634|NCT04721821|144494099|SUPERIORITY||Mean Difference (Final Values)|0.0|||||TWO_SIDED|95.0|-0.06|0.07||||||Month 6 follow-up visit analysis||0.07|-0.06|
72483635|NCT04721821|144494099|SUPERIORITY||Mean Difference (Final Values)|-0.03|||||TWO_SIDED|95.0|-0.12|0.06||||||Month 12 follow-up visit analysis||0.06|-0.12|
72483636|NCT04721821|144494100|SUPERIORITY||Mean Difference (Final Values)|-0.02|||||TWO_SIDED|95.0|-0.09|0.04||||||Month 6 follow-up visit analysis||0.04|-0.09|
72483637|NCT04721821|144494100|SUPERIORITY||Odds Ratio (OR)|0.02|||||TWO_SIDED|95.0|-0.06|0.09||||||Month 12 follow-up visit analysis||0.09|-0.06|
72483638|NCT04721821|144494101|SUPERIORITY||Odds Ratio (OR)|1.14|||||TWO_SIDED|95.0|0.9|1.45||||||Month 6 follow-up visit analysis||1.45|0.90|
72483639|NCT04721821|144494101|SUPERIORITY||Odds Ratio (OR)|0.71|||||TWO_SIDED|95.0|0.54|0.94||||||Month 12 follow-up visit analysis||0.94|0.54|
72483640|NCT04721821|144494102|SUPERIORITY||Odds Ratio (OR)|0.76|||||TWO_SIDED|95.0|0.53|1.11||||||Month 6 follow-up visit analysis||1.11|0.53|
72483641|NCT04721821|144494102|SUPERIORITY||Odds Ratio (OR)|1.08|||||TWO_SIDED|95.0|0.72|1.61||||||Month 12 follow-up visit analysis||1.61|0.72|
72483642|NCT04721821|144494103|SUPERIORITY||Odds Ratio (OR)|0.94|||||TWO_SIDED|95.0|0.73|1.21||||||Month 6 follow-up visit analysis||1.21|0.73|
72483643|NCT04721821|144494103|SUPERIORITY||Odds Ratio (OR)|1.04|||||TWO_SIDED|95.0|0.77|1.39||||||Month 12 follow-up visit analysis||1.39|0.77|
72483644|NCT04721821|144494104|SUPERIORITY||Odds Ratio (OR)|0.92|||||TWO_SIDED|95.0|0.64|1.32||||||Month 6 follow-up visit analysis||1.32|0.64|
72483645|NCT04721821|144494104|SUPERIORITY||Odds Ratio (OR)|1.07|||||TWO_SIDED|95.0|0.69|1.64||||||Month 12 follow-up visit analysis||1.64|0.69|
72483646|NCT04721821|144494105|SUPERIORITY||Odds Ratio (OR)|1.16|||||TWO_SIDED|95.0|0.84|1.59||||||Month 6 follow-up visit analysis||1.59|0.84|
72483647|NCT04721821|144494105|SUPERIORITY||Odds Ratio (OR)|0.93|||||TWO_SIDED|95.0|0.65|1.32||||||Month 12 follow-up visit analysis||1.32|0.65|
72511973|NCT00243230|144554093|SUPERIORITY||VCV 20 mg vs. Placebo|-0.93||||0.0026||95.0|-1.54|-0.33|||ANOVA|ANOVA model adjusted for treatment and stratification factors - the use of T20 in current OBT and the baseline HIV-1 RNA ≤100,000 copies/mL.||||-0.33|-1.54|0.0026
72511974|NCT00243230|144554094|SUPERIORITY|||||||0.0052|||||||Cochran-Mantel-Haenszel|Cochran-Mantel Haenszel Test adjusted for stratification factors of T20 use in current OBT and baseline HIV-1 RNA.||||||0.0052
72511975|NCT00243230|144554094|SUPERIORITY|||||||0.019|||||||Cochran-Mantel-Haenszel|Cochran-Mantel Haenszel Test adjusted for stratification factors of T20 use in current OBT and baseline HIV-1 RNA.||||||0.0190
72511976|NCT00243230|144554095|SUPERIORITY|||||||0.0007|||||||Cochran-Mantel-Haenszel|Cochran-Mantel Haenszel Test adjusted for stratification factors of T20 use in current OBT and baseline HIV-1 RNA.||||||0.0007
72483648|NCT04721821|144494106|SUPERIORITY||Mean Difference (Final Values)|0.01|||||TWO_SIDED|95.0|-0.03|0.04||||||Month 6 follow-up visit analysis||0.04|-0.03|
72483649|NCT04721821|144494106|SUPERIORITY||Mean Difference (Final Values)|0.01|||||TWO_SIDED|95.0|-0.04|0.05||||||Month 12 follow-up visit analysis||0.05|-0.04|
72483650|NCT04721821|144494107|SUPERIORITY||Mean Difference (Final Values)|0.0|||||TWO_SIDED|95.0|-0.05|0.05||||||Month 6 follow-up visit analysis||0.05|-0.05|
72483651|NCT04721821|144494107|SUPERIORITY||Mean Difference (Final Values)|-0.01|||||TWO_SIDED|95.0|-0.07|0.06||||||Month 12 follow-up visit analysis||0.06|-0.07|
72483652|NCT04721821|144494108|SUPERIORITY||Mean Difference (Final Values)|-0.02|||||TWO_SIDED|95.0|-0.06|0.02||||||Month 6 follow-up visit analysis||0.02|-0.06|
72483653|NCT04721821|144494108|SUPERIORITY||Mean Difference (Final Values)|0.0|||||TWO_SIDED|95.0|-0.04|0.04||||||Month 12 follow-up visit analysis||0.04|-0.04|
72483654|NCT04721821|144494109|SUPERIORITY||Mean Difference (Final Values)|-0.01|||||TWO_SIDED|95.0|-0.06|0.04||||||Month 6 follow-up visit analysis||0.04|-0.06|
72483655|NCT04721821|144494109|SUPERIORITY||Mean Difference (Final Values)|-0.03|||||TWO_SIDED|95.0|-0.1|0.03||||||Month 12 follow-up visit analysis||0.03|-0.10|
72511977|NCT00243230|144554095|SUPERIORITY|||||||0.0028|||||||Cochran-Mantel-Haenszel|Cochran-Mantel Haenszel Test adjusted for stratification factors of T20 use in current OBT and baseline HIV-1 RNA.||||||0.0028
72511978|NCT00243230|144554097|SUPERIORITY||Vicriviroc 30mg - Placebo|-1.0||||0.0002|TWO_SIDED|95.0|-1.53|-0.48|||ANOVA|ANOVA model adjusted for treatment and stratification factors - the use of T20 in current OBT and the baseline HIV-1 RNA ≤100,000 copies/mL.||||-0.48|-1.53|0.0002
72511979|NCT00243230|144554097|SUPERIORITY||Vicriviroc 20 mg - Placebo|-0.84||||0.002|TWO_SIDED|95.0|-1.36|-0.31|||ANOVA|ANOVA model adjusted for treatment and stratification factors - the use of T20 in current OBT and the baseline HIV-1 RNA ≤100,000 copies/mL.||||-0.31|-1.36|0.0020
72483656|NCT04721821|144494110|SUPERIORITY||Mean Difference (Final Values)|-0.01|||||TWO_SIDED|95.0|-0.05|0.04||||||Month 6 follow-up visit analysis||0.04|-0.05|
72483657|NCT04721821|144494110|SUPERIORITY||Mean Difference (Final Values)|0.0|||||TWO_SIDED|95.0|-0.06|0.06||||||Month 12 follow-up visit analysis||0.06|-0.06|
72483658|NCT04721821|144494111|SUPERIORITY||Mean Difference (Final Values)|-0.1|||||TWO_SIDED|95.0|-2.65|2.45||||||Month 6 follow-up visit analysis||2.45|-2.65|
72483659|NCT04721821|144494111|SUPERIORITY||Mean Difference (Final Values)|0.26|||||TWO_SIDED|95.0|-2.59|3.11||||||Month 12 follow-up visit analysis||3.11|-2.59|
72483660|NCT04721821|144494112|SUPERIORITY||Mean Difference (Final Values)|0.83|||||TWO_SIDED|95.0|-2.71|4.38||||||Month 6 follow-up visit analysis||4.38|-2.71|
72483661|NCT04721821|144494112|SUPERIORITY||Mean Difference (Final Values)|-1.09|||||TWO_SIDED|95.0|-5.12|2.95||||||Month 12 follow-up visit analysis||2.95|-5.12|
72511980|NCT00243230|144554098|SUPERIORITY||Vicriviroc 30 mg - Placebo|-1.1||||0.0003|TWO_SIDED|95.0|-1.69|-0.51|||ANOVA|ANOVA model adjusted for treatment and stratification factors - the use of T20 in current OBT and the baseline HIV-1 RNA \<=100,000 copies/mL.||||-0.51|-1.69|0.0003
72483662|NCT04721821|144494113|SUPERIORITY||Mean Difference (Final Values)|-1.25|||||TWO_SIDED|95.0|-3.94|1.45||||||Month 6 follow-up visit analysis||1.45|-3.94|
72483663|NCT04721821|144494113|SUPERIORITY||Mean Difference (Final Values)|-0.59|||||TWO_SIDED|95.0|-3.61|2.42||||||Month 12 follow-up visit analysis||2.42|-3.61|
72483664|NCT04721821|144494114|SUPERIORITY||Mean Difference (Final Values)|-0.67|||||TWO_SIDED|95.0|-4.39|3.05||||||Month 6 follow-up visit analysis||3.05|-4.39|
72483665|NCT04721821|144494114|SUPERIORITY||Mean Difference (Final Values)|-4.84|||||TWO_SIDED|95.0|-9.19|-0.48||||||Month 12 follow-up visit analysis||-0.48|-9.19|
72483666|NCT04721821|144494115|SUPERIORITY||Mean Difference (Final Values)|-0.39|||||TWO_SIDED|95.0|-3.59|2.82||||||Month 6 follow-up visit analysis||2.82|-3.59|
72483667|NCT04721821|144494115|SUPERIORITY||Mean Difference (Final Values)|0.76|||||TWO_SIDED|95.0|-2.97|4.49||||||Month 12 follow-up visit analysis||4.49|-2.97|
72483668|NCT04721821|144494116|SUPERIORITY||Odds Ratio (OR)|0.99|||||TWO_SIDED|95.0|0.73|1.34||||||Month 6 follow-up visit analysis||1.34|0.73|
72483669|NCT04721821|144494116|SUPERIORITY||Odds Ratio (OR)|0.94|||||TWO_SIDED|95.0|0.66|1.34||||||Month 12 follow-up visit analysis||1.34|0.66|
72483670|NCT04721821|144494117|SUPERIORITY||Odds Ratio (OR)|1.04|||||TWO_SIDED|95.0|0.62|1.73||||||Month 6 follow-up visit analysis||1.73|0.62|
72483671|NCT04721821|144494117|SUPERIORITY||Odds Ratio (OR)|0.9|||||TWO_SIDED|95.0|0.5|1.6||||||Month 12 follow-up visit analysis||1.60|0.50|
72483672|NCT04721821|144494118|SUPERIORITY||Odds Ratio (OR)|0.87|||||TWO_SIDED|95.0|0.64|1.19||||||Month 6 follow-up visit analysis||1.19|0.64|
72483673|NCT04721821|144494118|SUPERIORITY||Odds Ratio (OR)|0.87|||||TWO_SIDED|95.0|0.6|1.26||||||Month 12 follow-up visit analysis||1.26|0.60|
72483674|NCT04721821|144494119|SUPERIORITY||Odds Ratio (OR)|0.89|||||TWO_SIDED|95.0|0.55|1.46||||||Month 6 follow-up visit analysis||1.46|0.55|
72483675|NCT04721821|144494119|SUPERIORITY||Odds Ratio (OR)|0.84|||||TWO_SIDED|95.0|0.47|1.51||||||Month 12 follow-up visit analysis||1.51|0.47|
72483676|NCT04721821|144494120|SUPERIORITY||Odds Ratio (OR)|0.91|||||TWO_SIDED|95.0|0.6|1.38||||||Month 6 follow-up visit analysis||1.38|0.60|
72483677|NCT04721821|144494120|SUPERIORITY||Odds Ratio (OR)|0.91|||||TWO_SIDED|95.0|0.56|1.5||||||Month 12 follow-up visit analysis||1.50|0.56|
72483678|NCT04721821|144494121|SUPERIORITY||Mean Difference (Final Values)|1.71|||||TWO_SIDED|95.0|-0.69|4.11||||||Month 6 follow-up visit analysis||4.11|-0.69|
72483679|NCT04721821|144494121|SUPERIORITY||Mean Difference (Final Values)|-0.01|||||TWO_SIDED|95.0|-2.79|2.77||||||Month 12 follow-up visit analysis||2.77|-2.79|
72483680|NCT04721821|144494122|SUPERIORITY||Mean Difference (Final Values)|-1.71|||||TWO_SIDED|95.0|-5.02|1.6||||||Month 6 follow-up visit analysis||1.60|-5.02|
72483681|NCT04721821|144494122|SUPERIORITY||Mean Difference (Final Values)|1.06|||||TWO_SIDED|95.0|-2.85|4.96||||||Month 12 follow-up visit analysis||4.96|-2.85|
72483682|NCT04721821|144494123|SUPERIORITY||Mean Difference (Final Values)|-1.15|||||TWO_SIDED|95.0|-3.75|1.45||||||Month 6 follow-up visit analysis||1.45|-3.75|
72483683|NCT04721821|144494123|SUPERIORITY||Median Difference (Final Values)|-0.53|||||TWO_SIDED|95.0|-3.54|2.47||||||Month 12 follow-up visit analysis||2.47|-3.54|
72483684|NCT04721821|144494124|SUPERIORITY||Mean Difference (Final Values)|1.19|||||TWO_SIDED|95.0|-2.36|4.73||||||Month 6 follow-up visit analysis||4.73|-2.36|
72483685|NCT04721821|144494124|SUPERIORITY||Mean Difference (Final Values)|-3.15|||||TWO_SIDED|95.0|-7.36|1.07||||||Month 12 follow-up visit analysis||1.07|-7.36|
72483686|NCT04721821|144494125|SUPERIORITY||Mean Difference (Final Values)|2.37|||||TWO_SIDED|95.0|-0.66|5.41||||||Month 6 follow-up visit analysis||5.41|-0.66|
72483687|NCT04721821|144494125|SUPERIORITY||Mean Difference (Final Values)|1.01|||||TWO_SIDED|95.0|-2.69|4.71||||||Month 12 follow-up visit analysis||4.71|-2.69|
72567258|NCT01763918|144665501|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-46.59|STANDARD_ERROR_OF_MEAN|2.45|<|0.001|TWO_SIDED|95.0|-51.43|-41.76||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C and ezetimibe use, scheduled visit, and the interaction of treatment with scheduled visit.||||-41.76|-51.43|<0.001
72483688|NCT04721821|144494126|SUPERIORITY||Mean Difference (Final Values)|0.12|||||TWO_SIDED|95.0|-0.16|0.4||||||Month 6 follow-up visit analysis||0.40|-0.16|
72483689|NCT04721821|144494126|SUPERIORITY||Mean Difference (Final Values)|0.12|||||TWO_SIDED|95.0|-0.21|0.45||||||Month 12 follow-up visit analysis||0.45|-0.21|
72483690|NCT04721821|144494127|SUPERIORITY||Mean Difference (Final Values)|0.02|||||TWO_SIDED|95.0|-0.4|0.43||||||Month 6 follow-up visit analysis||0.43|-0.40|
72483691|NCT04721821|144494127|SUPERIORITY||Mean Difference (Final Values)|-0.23|||||TWO_SIDED|95.0|-0.74|0.29||||||Month 12 follow-up visit analysis||0.29|-0.74|
72483692|NCT04721821|144494128|SUPERIORITY||Mean Difference (Final Values)|-0.2|||||TWO_SIDED|95.0|-0.51|0.1||||||Month 6 follow-up visit analysis||0.10|-0.51|
72483693|NCT04721821|144494128|SUPERIORITY||Mean Difference (Final Values)|-0.05|||||TWO_SIDED|95.0|-0.42|0.31||||||Month 12 follow-up visit analysis||0.31|-0.42|
72483694|NCT04721821|144494129|SUPERIORITY||Mean Difference (Final Values)|-0.01|||||TWO_SIDED|95.0|-0.34|0.32||||||Month 6 follow-up visit analysis||0.32|-0.34|
72483695|NCT04721821|144494129|SUPERIORITY||Mean Difference (Final Values)|-0.19|||||TWO_SIDED|95.0|-0.69|0.31||||||Month 12 follow-up visit analysis||0.31|-0.69|
72483696|NCT04721821|144494130|SUPERIORITY||Mean Difference (Final Values)|-0.03|||||TWO_SIDED|95.0|-0.37|0.32||||||Month 6 follow-up visit analysis||0.32|-0.37|
72483697|NCT04721821|144494130|SUPERIORITY||Mean Difference (Final Values)|0.15|||||TWO_SIDED|95.0|-0.3|0.59||||||Month 12 follow-up visit analysis||0.59|-0.30|
72483698|NCT01009554|144494137|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.126|STANDARD_ERROR_OF_MEAN|0.0905||0.168|TWO_SIDED|95.0|-0.054|0.306||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline tooth color parameter values (L, a, and b) and age (in years) as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.306|-0.054|0.168
72483699|NCT01009554|144494139|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.006|STANDARD_ERROR_OF_MEAN|0.067||0.928|TWO_SIDED|95.0|-0.127|0.139||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline tooth color parameter values (L, a, and b) and age (in years) as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.139|-0.127|0.928
72483700|NCT01009554|144494140|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.235|STANDARD_ERROR_OF_MEAN|0.0718||0.002|TWO_SIDED|95.0|0.092|0.378||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline tooth color parameter values (L, a, and b) and age (in years) as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.378|0.092|0.002
72483701|NCT01009554|144494141|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.041|STANDARD_ERROR_OF_MEAN|0.1235||0.741|TWO_SIDED|95.0|-0.205|0.286||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline tooth color parameter value L and age (in years) as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.286|-0.205|0.741
72511981|NCT00243230|144554098|SUPERIORITY||Vicriviroc 20 mg - Placebo|-1.07||||0.0004|TWO_SIDED|95.0|-1.66|-0.49|||ANOVA|ANOVA model adjusted for treatment and stratification factors - the use of T20 in current OBT and the baseline HIV-1 RNA \<=100,000 copies/mL.||||-0.49|-1.66|0.0004
72511982|NCT00243230|144554099|SUPERIORITY||VCV 30 mg - Placebo|57.76||||0.0264|TWO_SIDED|95.0|6.9|108.61|||ANOVA|ANOVA model adjusted for treatment and stratification factors - the use of T20 in current OBT and the baseline HIV-1 RNA ≤100,000 copies/mL.||||108.61|6.90|0.0264
72483702|NCT01009554|144494142|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.161|STANDARD_ERROR_OF_MEAN|0.1386||0.249|TWO_SIDED|95.0|-0.437|0.115||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline tooth color parameter value L and age (in years) as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.115|-0.437|0.249
72483703|NCT01009554|144494143|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.201|STANDARD_ERROR_OF_MEAN|0.1398||0.154|TWO_SIDED|95.0|-0.479|0.077||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline tooth color parameter value L and age (in years) as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.077|-0.479|0.154
72483704|NCT01009554|144494144|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.195|STANDARD_ERROR_OF_MEAN|0.0746||0.011|TWO_SIDED|95.0|-0.343|-0.047||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline tooth color parameter value b and age (in years) as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-0.047|-0.343|0.011
72483705|NCT01009554|144494145|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.334|STANDARD_ERROR_OF_MEAN|0.0703|<|0.001|TWO_SIDED|95.0|-0.474|-0.195||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline tooth color parameter value b and age (in years) as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-0.195|-0.474|<0.001
72483706|NCT01009554|144494146|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.214|STANDARD_ERROR_OF_MEAN|0.0939||0.025|TWO_SIDED|95.0|-0.401|-0.027||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline tooth color parameter value b and age (in years) as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-0.027|-0.401|0.025
72402284|NCT01480076|144311670|SUPERIORITY_OR_OTHER|||||||0.0789|||||||mixed effect model|||Month 6, Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of the current health state of EQ-5D scores, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0789
72402285|NCT01480076|144311670|SUPERIORITY_OR_OTHER||least squares mean|9.7|STANDARD_ERROR_OF_MEAN|2.0|<|0.0001|TWO_SIDED||||||mixed effect model|||Month 6, Responder Versus Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of the current health state of EQ-5D scores, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
72402286|NCT01480076|144311670|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 9, Responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of the current health state of EQ-5D scores, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
72402287|NCT01480076|144311670|SUPERIORITY_OR_OTHER|||||||0.0284|||||||mixed effect model|||Month 9, Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of the current health state of EQ-5D scores, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0284
72402288|NCT01480076|144311670|SUPERIORITY_OR_OTHER||least squares mean|11.2|STANDARD_ERROR_OF_MEAN|2.16|<|0.0001|TWO_SIDED||||||mixed effect model|||Month 9, Responder Versus Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of the current health state of EQ-5D scores, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
72402289|NCT01480076|144311670|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 12, Responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of the current health state of EQ-5D scores, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
72402290|NCT01480076|144311670|SUPERIORITY_OR_OTHER|||||||0.0108|||||||mixed effect model|||Month 12, Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of the current health state of EQ-5D scores, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0108
72402291|NCT01480076|144311670|SUPERIORITY_OR_OTHER||least squares mean|12.3|STANDARD_ERROR_OF_MEAN|2.29|<|0.0001|TWO_SIDED||||||mixed effect model|||Month 12, Responder Versus Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of the current health state of EQ-5D scores, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
72402292|NCT01480076|144311671|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Overall, Responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of current health state of EQ-5D scores, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
72402293|NCT01480076|144311671|SUPERIORITY_OR_OTHER|||||||0.8392|||||||mixed effect model|||Overall, Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of current health state of EQ-5D scores, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.8392
72402294|NCT01480076|144311671|SUPERIORITY_OR_OTHER||least squares mean|0.04|STANDARD_ERROR_OF_MEAN|0.02||0.0162|TWO_SIDED||||||mixed effect model|||Overall, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of current health state of EQ-5D scores, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0162
72402295|NCT01480076|144311671|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 3, Responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of current health state of EQ-5D scores, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
72402296|NCT01480076|144311671|SUPERIORITY_OR_OTHER|||||||0.6956|||||||mixed effect model|||Month 3, Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of current health state of EQ-5D scores, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.6956
72402297|NCT01480076|144311671|SUPERIORITY_OR_OTHER||least squares mean|0.06|STANDARD_ERROR_OF_MEAN|0.02||0.0042|TWO_SIDED||||||mixed effect model|||Month 3, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of current health state of EQ-5D scores, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0042
72511983|NCT00243230|144554099|SUPERIORITY||VCV 20 mg - Placebo|42.36||||0.102|TWO_SIDED|95.0|-8.55|93.28|||ANOVA|ANOVA model adjusted for treatment and stratification factors - the use of T20 in current OBT and the baseline HIV-1 RNA ≤100,000 copies/mL.||||93.28|-8.55|0.1020
72567259|NCT01763918|144665501|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-49.16|STANDARD_ERROR_OF_MEAN|2.56|<|0.001|TWO_SIDED|95.0|-54.21|-44.11||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C and ezetimibe use, scheduled visit, and the interaction of treatment with scheduled visit.||||-44.11|-54.21|<0.001
72402298|NCT01480076|144311671|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 6, Responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of current health state of EQ-5D scores, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
72567260|NCT01763918|144665502|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-46.08|STANDARD_ERROR_OF_MEAN|2.63|<|0.001|TWO_SIDED|95.0|-51.27|-40.88||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C and ezetimibe use, scheduled visit, and the interaction of treatment with scheduled visit.||||-40.88|-51.27|<0.001
72567261|NCT01763918|144665502|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-45.42|STANDARD_ERROR_OF_MEAN|3.77|<|0.001|TWO_SIDED|95.0|-52.86|-37.98||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C and ezetimibe use, scheduled visit, and the interaction of treatment with scheduled visit.||||-37.98|-52.86|<0.001
72567262|NCT01763918|144665503|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-53.17|STANDARD_ERROR_OF_MEAN|2.62|<|0.001|TWO_SIDED|95.0|-58.35|-47.99||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C and ezetimibe use, scheduled visit, and the interaction of treatment with scheduled visit.||||-47.99|-58.35|<0.001
72567263|NCT01763918|144665503|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-55.56|STANDARD_ERROR_OF_MEAN|2.79|<|0.001|TWO_SIDED|95.0|-61.08|-50.05||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C and ezetimibe use, scheduled visit, and the interaction of treatment with scheduled visit.||||-50.05|-61.08|<0.001
72567264|NCT01763918|144665504|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-54.28|STANDARD_ERROR_OF_MEAN|2.97|<|0.001|TWO_SIDED|95.0|-60.16|-48.41||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C and ezetimibe use, scheduled visit, and the interaction of treatment with scheduled visit.||||-48.41|-60.16|<0.001
72567265|NCT01763918|144665504|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-49.55|STANDARD_ERROR_OF_MEAN|4.35|<|0.001|TWO_SIDED|95.0|-58.14|-40.96||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C and ezetimibe use, scheduled visit, and the interaction of treatment with scheduled visit.||||-40.96|-58.14|<0.001
72567266|NCT01763918|144665505|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-31.37|STANDARD_ERROR_OF_MEAN|3.52|<|0.001|TWO_SIDED|95.0|-38.33|-24.41||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C and ezetimibe use, scheduled visit, and the interaction of treatment with scheduled visit.||||-24.41|-38.33|<0.001
72624067|NCT03537508|144778465|NON_INFERIORITY|The overall non-inferiority was demonstrated if the lower limit of the 2-sided 95% confidence interval (CI) was \>-10% for all 4 serogroups. 95% CI of the difference was calculated from the Wilson Score method without continuity correction.|Difference in Percentage of Participants|1.86|||||TWO_SIDED|95.0|-4.38|8.64||||||Statistical analysis for Serogroup A||8.64|-4.38|
72402299|NCT01480076|144311671|SUPERIORITY_OR_OTHER|||||||0.7949|||||||mixed effect model|||Month 6, Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of current health state of EQ-5D scores, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.7949
72567267|NCT01763918|144665505|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-31.0|STANDARD_ERROR_OF_MEAN|3.5|<|0.001|TWO_SIDED|95.0|-37.91|-24.09||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C and ezetimibe use, scheduled visit, and the interaction of treatment with scheduled visit.||||-24.09|-37.91|<0.001
72567268|NCT01763918|144665506|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-31.57|STANDARD_ERROR_OF_MEAN|3.9|<|0.001|TWO_SIDED|95.0|-39.28|-23.87||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C and ezetimibe use, scheduled visit, and the interaction of treatment with scheduled visit.||||-23.87|-39.28|<0.001
72567269|NCT01763918|144665506|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-28.24|STANDARD_ERROR_OF_MEAN|3.73|<|0.001|TWO_SIDED|95.0|-35.61|-20.88||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C and ezetimibe use, scheduled visit, and the interaction of treatment with scheduled visit.||||-20.88|-35.61|<0.001
72624068|NCT03537508|144778465|NON_INFERIORITY|The overall non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI was \>-10% for all 4 serogroups. 95% CI of the difference was calculated from the Wilson Score method without continuity correction.|Difference in Percentage of Participants|8.75|||||TWO_SIDED|95.0|4.8|13.6||||||Statistical analysis for Serogroup C||13.60|4.80|
72402300|NCT01480076|144311671|SUPERIORITY_OR_OTHER||least squares mean|0.04|STANDARD_ERROR_OF_MEAN|0.02||0.0679|TWO_SIDED||||||mixed effect model|||Month 6, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of current health state of EQ-5D scores, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0679
72402301|NCT01480076|144311671|SUPERIORITY_OR_OTHER|||||||0.0027|||||||mixed effect model|||Month 9, Responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of current health state of EQ-5D scores, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0027
72483707|NCT01009554|144494147|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.056|STANDARD_ERROR_OF_MEAN|0.0562||0.319|TWO_SIDED|95.0|-0.055|0.168||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain score over all tooth sites and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.168|-0.055|0.319
72483708|NCT01009554|144494148|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.272|STANDARD_ERROR_OF_MEAN|0.0668|<|0.001|TWO_SIDED|95.0|0.139|0.405||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain score over all tooth sites and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.405|0.139|<0.001
72483709|NCT01009554|144494149|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.398|STANDARD_ERROR_OF_MEAN|0.084|<|0.001|TWO_SIDED|95.0|0.231|0.565||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain score over all tooth sites and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.565|0.231|<0.001
72483710|NCT01009554|144494150|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.03|STANDARD_ERROR_OF_MEAN|0.0271||0.27|TWO_SIDED|95.0|-0.024|0.084||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain intensity over all tooth sites and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.084|-0.024|0.270
72483711|NCT01009554|144494151|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.137|STANDARD_ERROR_OF_MEAN|0.0324|<|0.001|TWO_SIDED|95.0|0.073|0.202||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain intensity over all tooth sites and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.202|0.073|<0.001
72483712|NCT01009554|144494152|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.193|STANDARD_ERROR_OF_MEAN|0.0399|<|0.001|TWO_SIDED|95.0|0.114|0.273||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain intensity over all tooth sites and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.273|0.114|<0.001
72567270|NCT01763918|144665507|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-22.36|STANDARD_ERROR_OF_MEAN|3.6|<|0.001|TWO_SIDED|95.0|-29.48|-15.24||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C and ezetimibe use, scheduled visit, and the interaction of treatment with scheduled visit.||||-15.24|-29.48|<0.001
72624069|NCT03537508|144778465|NON_INFERIORITY|The overall non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI was \>-10% for all 4 serogroups. 95% CI of the difference was calculated from the Wilson Score method without continuity correction.|Difference in Percentage of Participants|4.09|||||TWO_SIDED|95.0|0.68|8.44||||||Statistical analysis for Serogroup Y||8.44|0.68|
72402302|NCT01480076|144311671|SUPERIORITY_OR_OTHER|||||||0.8053|||||||mixed effect model|||Month 9, Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of current health state of EQ-5D scores, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.8053
72402303|NCT01480076|144311671|SUPERIORITY_OR_OTHER||least squares mean|0.03|STANDARD_ERROR_OF_MEAN|0.03||0.2638|TWO_SIDED||||||mixed effect model|||Month 9, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of current health state of EQ-5D scores, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.2638
72402304|NCT01480076|144311671|SUPERIORITY_OR_OTHER|||||||0.0007|||||||mixed effect model|||Month 12, Responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of current health state of EQ-5D scores, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0007
72402305|NCT01480076|144311671|SUPERIORITY_OR_OTHER|||||||0.8502|||||||mixed effect model|||Month 12, Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of current health state of EQ-5D scores, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.8502
72402306|NCT01480076|144311671|SUPERIORITY_OR_OTHER||least squares mean|0.05|STANDARD_ERROR_OF_MEAN|0.03||0.0917|TWO_SIDED||||||mixed effect model|||Month 12, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of current health state of EQ-5D scores, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0917
72402307|NCT01480076|144311672|SUPERIORITY_OR_OTHER|||||||0.1795|||||||mixed effect model|||Overall, Responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage of work time missed due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.1795
72402308|NCT01480076|144311672|SUPERIORITY_OR_OTHER|||||||0.0715|||||||mixed effect model|||Overall, Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage of work time missed due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0715
72567271|NCT01763918|144665507|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-16.74|STANDARD_ERROR_OF_MEAN|3.89|<|0.001|TWO_SIDED|95.0|-24.43|-9.05||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C and ezetimibe use, scheduled visit, and the interaction of treatment with scheduled visit.||||-9.05|-24.43|<0.001
72402309|NCT01480076|144311672|SUPERIORITY_OR_OTHER||least squares mean|5.8|STANDARD_ERROR_OF_MEAN|4.6||0.2065|TWO_SIDED||||||mixed effect model|||Overall, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage of work time missed due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.2065
72402310|NCT01480076|144311672|SUPERIORITY_OR_OTHER|||||||0.1649|||||||mixed effect model|||Month 3, Responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage of work time missed due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.1649
72402311|NCT01480076|144311672|SUPERIORITY_OR_OTHER|||||||0.4894|||||||mixed effect model|||Month 3, Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage of work time missed due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.4894
72402312|NCT01480076|144311672|SUPERIORITY_OR_OTHER||least squares mean|1.0|STANDARD_ERROR_OF_MEAN|5.89||0.8611|TWO_SIDED||||||mixed effect model|||Month 3, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage of work time missed due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.8611
72402313|NCT01480076|144311672|SUPERIORITY_OR_OTHER|||||||0.0073|||||||mixed effect model|||Month 6, Responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage of work time missed due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0073
72402314|NCT01480076|144311672|SUPERIORITY_OR_OTHER|||||||0.1343|||||||mixed effect model|||Month 6, Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage of work time missed due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.1343
72483713|NCT01009554|144494153|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.034|STANDARD_ERROR_OF_MEAN|0.0273||0.217|TWO_SIDED|95.0|-0.02|0.088||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain area over all tooth sites and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.088|-0.020|0.217
72483714|NCT01009554|144494154|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.137|STANDARD_ERROR_OF_MEAN|0.032|<|0.001|TWO_SIDED|95.0|0.073|0.2||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain area over all tooth sites and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.200|0.073|<0.001
72483715|NCT01009554|144494155|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.195|STANDARD_ERROR_OF_MEAN|0.0406|<|0.001|TWO_SIDED|95.0|0.114|0.276||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain area over all tooth sites and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.276|0.114|<0.001
72483716|NCT01009554|144494156|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.055|STANDARD_ERROR_OF_MEAN|0.0716||0.444|TWO_SIDED|95.0|-0.087|0.197||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain area score for interproximal (mesial and distal) sites and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.197|-0.087|0.444
72483717|NCT01009554|144494157|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.349|STANDARD_ERROR_OF_MEAN|0.0843|<|0.001|TWO_SIDED|95.0|0.182|0.517||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain score for interproximal (mesial and distal) sites and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.517|0.182|<0.001
72402315|NCT01480076|144311672|SUPERIORITY_OR_OTHER||least squares mean|2.3|STANDARD_ERROR_OF_MEAN|5.09||0.6468|TWO_SIDED||||||mixed effect model|||Month 6, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage of work time missed due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.6468
72402316|NCT01480076|144311672|SUPERIORITY_OR_OTHER|||||||0.6441|||||||mixed effect model|||Month 9, Responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage of work time missed due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.6441
72402317|NCT01480076|144311672|SUPERIORITY_OR_OTHER|||||||0.2176|||||||mixed effect model|||Month 9, Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage of work time missed due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.2176
72402318|NCT01480076|144311672|SUPERIORITY_OR_OTHER||least squares mean|8.5|STANDARD_ERROR_OF_MEAN|7.91||0.2814|TWO_SIDED||||||mixed effect model|||Month 9, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage of work time missed due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.2814
72402319|NCT01480076|144311672|SUPERIORITY_OR_OTHER|||||||0.7533|||||||mixed effect model|||Month 12, Responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage of work time missed due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.7533
72402320|NCT01480076|144311672|SUPERIORITY_OR_OTHER|||||||0.0653|||||||mixed effect model|||Month 12, Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage of work time missed due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0653
72402321|NCT01480076|144311672|SUPERIORITY_OR_OTHER||least squares mean|11.4|STANDARD_ERROR_OF_MEAN|6.65||0.0876|TWO_SIDED||||||mixed effect model|||Month 12, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage of work time missed due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0876
72402322|NCT01480076|144311673|SUPERIORITY_OR_OTHER|||||||0.0281|||||||mixed effect model|||Overall, Responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage impairment while working due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0281
72402323|NCT01480076|144311673|SUPERIORITY_OR_OTHER|||||||0.0654|||||||mixed effect model|||Overall, Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage impairment while working due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0654
72402324|NCT01480076|144311673|SUPERIORITY_OR_OTHER||least squares mean|4.3|STANDARD_ERROR_OF_MEAN|4.47||0.34|TWO_SIDED||||||mixed effect model|||Overall, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage impairment while working due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.3400
72402325|NCT01480076|144311673|SUPERIORITY_OR_OTHER|||||||0.0012|||||||mixed effect model|||Month 3, Responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage impairment while working due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0012
72402326|NCT01480076|144311673|SUPERIORITY_OR_OTHER|||||||0.749|||||||mixed effect model|||Month 3, Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage impairment while working due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.7490
72624070|NCT03537508|144778465|NON_INFERIORITY|The overall non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI was \>-10% for all 4 serogroups. 95% CI of the difference was calculated from the Wilson Score method without continuity correction.|Difference in Percentage of Participants|1.19|||||TWO_SIDED|95.0|-1.18|4.45||||||Statistical analysis for Serogroup W||4.45|-1.18|
72402327|NCT01480076|144311673|SUPERIORITY_OR_OTHER||least squares mean|-5.1|STANDARD_ERROR_OF_MEAN|5.53||0.3592|TWO_SIDED||||||mixed effect model|||Month 3, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage impairment while working due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.3592
72402328|NCT01480076|144311673|SUPERIORITY_OR_OTHER|||||||0.0015|||||||mixed effect model|||Month 6, Responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage impairment while working due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0015
72402329|NCT01480076|144311673|SUPERIORITY_OR_OTHER|||||||0.2967|||||||mixed effect model|||Month 6, Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage impairment while working due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.2967
72402330|NCT01480076|144311673|SUPERIORITY_OR_OTHER||least squares mean|-0.9|STANDARD_ERROR_OF_MEAN|5.34||0.8735|TWO_SIDED||||||mixed effect model|||Month 6, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage impairment while working due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.8735
72402331|NCT01480076|144311673|SUPERIORITY_OR_OTHER|||||||0.1696|||||||mixed effect model|||Month 9, Responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage impairment while working due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.1696
72402332|NCT01480076|144311673|SUPERIORITY_OR_OTHER|||||||0.0089|||||||mixed effect model|||Month 9, Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage impairment while working due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0089
72402333|NCT01480076|144311673|SUPERIORITY_OR_OTHER||least squares mean|14.9|STANDARD_ERROR_OF_MEAN|6.83||0.0297|TWO_SIDED||||||mixed effect model|||Month 9, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage impairment while working due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0297
72402334|NCT01480076|144311673|SUPERIORITY_OR_OTHER|||||||0.8806|||||||mixed effect model|||Month 12, Responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage impairment while working due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.8806
72402335|NCT01480076|144311673|SUPERIORITY_OR_OTHER|||||||0.217|||||||mixed effect model|||Month 12, Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage impairment while working due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.2170
72402336|NCT01480076|144311673|SUPERIORITY_OR_OTHER||least squares mean|8.1|STANDARD_ERROR_OF_MEAN|6.86||0.2392|TWO_SIDED||||||mixed effect model|||Month 12, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage impairment while working due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.2392
72483718|NCT01009554|144494158|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.542|STANDARD_ERROR_OF_MEAN|0.1063|<|0.001|TWO_SIDED|95.0|0.331|0.754||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain score for interproximal (mesial and distal) sites and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.754|0.331|<0.001
72483719|NCT01009554|144494159|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.032|STANDARD_ERROR_OF_MEAN|0.0344||0.361|TWO_SIDED|95.0|-0.037|0.1||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain intensity for interproximal (mesial and distal) sites and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.100|-0.037|0.361
72483720|NCT01009554|144494160|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.174|STANDARD_ERROR_OF_MEAN|0.0414|<|0.001|TWO_SIDED|95.0|0.092|0.256||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain intensity for interproximal (mesial and distal) sites and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.256|0.092|<0.001
72483721|NCT01009554|144494161|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.264|STANDARD_ERROR_OF_MEAN|0.0504|<|0.001|TWO_SIDED|95.0|0.164|0.364||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain intensity for interproximal (mesial and distal) sites and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.364|0.164|<0.001
72483722|NCT01009554|144494162|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.034|STANDARD_ERROR_OF_MEAN|0.0345||0.331|TWO_SIDED|95.0|-0.035|0.102||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain area for interproximal (mesial and distal) sites and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.102|-0.035|0.331
72511984|NCT00243230|144554100|SUPERIORITY||VCV 30 mg - Placebo|38.12||||0.1525|TWO_SIDED|95.0|-14.32|90.56|||ANOVA|ANOVA model adjusted for treatment and stratification factors - the use of T20 in current OBT and the baseline HIV-1 RNA ≤100,000 copies/mL.||||90.56|-14.32|0.1525
72624071|NCT03537508|144778466|NON_INFERIORITY|The overall non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI was \>-10% for all 4 serogroups. 95% CI of the difference was calculated from the Wilson Score method without continuity correction.|Difference in Percentage of Participants|10.21|||||TWO_SIDED|95.0|4.98|15.59||||||Statistical analysis for Serogroup A||15.59|4.98|
72402337|NCT01480076|144311674|SUPERIORITY_OR_OTHER|||||||0.0219|||||||mixed effect model|||Overall, Responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage overall work impairment due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0219
72402338|NCT01480076|144311674|SUPERIORITY_OR_OTHER|||||||0.1259|||||||mixed effect model|||Overall, Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage overall work impairment due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.1259
72402339|NCT01480076|144311674|SUPERIORITY_OR_OTHER||least squares mean|3.6|STANDARD_ERROR_OF_MEAN|5.68||0.5312|TWO_SIDED||||||mixed effect model|||Overall, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage overall work impairment due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.5312
72402340|NCT01480076|144311674|SUPERIORITY_OR_OTHER|||||||0.0022|||||||mixed effect model|||Month 3, Responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage overall work impairment due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0022
72402341|NCT01480076|144311674|SUPERIORITY_OR_OTHER|||||||0.4968|||||||mixed effect model|||Month 3, Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage overall work impairment due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.4968
72402342|NCT01480076|144311674|SUPERIORITY_OR_OTHER||least squares mean|-3.2|STANDARD_ERROR_OF_MEAN|6.64||0.6283|TWO_SIDED||||||mixed effect model|||Month 3, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage overall work impairment due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.6283
72483723|NCT01009554|144494163|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.177|STANDARD_ERROR_OF_MEAN|0.0414|<|0.001|TWO_SIDED|95.0|0.095|0.259||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain area for interproximal (mesial and distal) sites and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.259|0.095|<0.001
72483724|NCT01009554|144494164|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.265|STANDARD_ERROR_OF_MEAN|0.0519|<|0.001|TWO_SIDED|95.0|0.162|0.368||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain area for interproximal (mesial and distal) sites and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.368|0.162|<0.001
72483725|NCT01009554|144494165|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.138|STANDARD_ERROR_OF_MEAN|0.0726||0.06|TWO_SIDED|95.0|-0.006|0.282||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain score for the gingival region and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.282|-0.006|0.060
72483726|NCT01009554|144494166|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.338|STANDARD_ERROR_OF_MEAN|0.087|<|0.001|TWO_SIDED|95.0|0.165|0.51||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain score for the gingival region and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.510|0.165|<0.001
72483727|NCT01009554|144494167|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.394|STANDARD_ERROR_OF_MEAN|0.1095|<|0.001|TWO_SIDED|95.0|0.176|0.612||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain score for the gingival region and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.612|0.176|<0.001
72483728|NCT01009554|144494168|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.072|STANDARD_ERROR_OF_MEAN|0.0355||0.045|TWO_SIDED|95.0|0.002|0.143||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain intensity for the gingival region and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.143|0.002|0.045
72483729|NCT01009554|144494169|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.178|STANDARD_ERROR_OF_MEAN|0.0415|<|0.001|TWO_SIDED|95.0|0.095|0.26||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain intensity for the gingival region and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.260|0.095|<0.001
72511985|NCT00243230|144554100|SUPERIORITY||VCV 20 mg - Placebo|44.12||||0.0987|TWO_SIDED|95.0|-8.38|96.61|||ANOVA|ANOVA model adjusted for treatment and stratification factors - the use of T20 in current OBT and the baseline HIV-1 RNA ≤100,000 copies/mL.||||96.61|-8.38|0.0987
72511986|NCT00243230|144554101|SUPERIORITY||VCV 30 mg - Placebo|37.32||||0.2603|TWO_SIDED|95.0|-28.05|102.68|||ANOVA|ANOVA model adjusted for treatment and stratification factors - the use of T20 in current OBT and the baseline HIV-1 RNA ≤100,000 copies/mL.||||102.68|-28.05|0.2603
72402343|NCT01480076|144311674|SUPERIORITY_OR_OTHER|||||||0.0016|||||||mixed effect model|||Month 6, Responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage overall work impairment due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0016
72402344|NCT01480076|144311674|SUPERIORITY_OR_OTHER|||||||0.6631|||||||mixed effect model|||Month 6, Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage overall work impairment due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.6631
72483730|NCT01009554|144494170|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.197|STANDARD_ERROR_OF_MEAN|0.052|<|0.001|TWO_SIDED|95.0|0.094|0.3||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain intensity for the gingival region and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.300|0.094|<0.001
72511987|NCT00243230|144554101|SUPERIORITY||VCV 20 mg - Placebo|69.08||||0.0387|TWO_SIDED|95.0|3.64|134.52|||ANOVA|ANOVA model adjusted for treatment and stratification factors - the use of T20 in current OBT and the baseline HIV-1 RNA ≤100,000 copies/mL.||||134.52|3.64|0.0387
72511988|NCT00243230|144554103|SUPERIORITY|||||||0.0031|||||||Cochran-Mantel-Haenszel|Cochran-Mantel Haenszel Test adjusted for stratification factors of T20 use in current OBT and baseline HIV-1 RNA.||||||0.0031
72402345|NCT01480076|144311674|SUPERIORITY_OR_OTHER||least squares mean|-4.8|STANDARD_ERROR_OF_MEAN|6.77||0.477|TWO_SIDED||||||mixed effect model|||Month 6, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage overall work impairment due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.4770
72511989|NCT00243230|144554103|SUPERIORITY|||||||0.048|||||||Cochran-Mantel-Haenszel|Cochran-Mantel Haenszel Test adjusted for stratification factors of T20 use in current OBT and baseline HIV-1 RNA.||||||0.0480
72511990|NCT00243230|144554104|SUPERIORITY|||||||0.0009|||||||Cochran-Mantel-Haenszel|Cochran-Mantel Haenszel Test adjusted for stratification factors of T20 use in current OBT and baseline HIV-1 RNA.||||||0.0009
72511991|NCT00243230|144554104|SUPERIORITY|||||||0.0009|||||||Cochran-Mantel-Haenszel|Cochran-Mantel Haenszel Test adjusted for stratification factors of T20 use in current OBT and baseline HIV-1 RNA.||||||0.0009
72511992|NCT00243230|144554106|SUPERIORITY|||||||0.0225|||||||Cochran-Mantel-Haenszel|Cochran-Mantel Haenszel Test adjusted for stratification factors of T20 use in current OBT and baseline HIV-1 RNA.||||||0.0225
72511993|NCT00243230|144554106|SUPERIORITY|||||||0.0582|||||||Cochran-Mantel-Haenszel|Cochran-Mantel Haenszel Test adjusted for stratification factors of T20 use in current OBT and baseline HIV-1 RNA.||||||0.0582
72511994|NCT00243230|144554107|SUPERIORITY|||||||0.0009|||||||Cochran-Mantel-Haenszel|Cochran-Mantel Haenszel Test adjusted for stratification factors of T20 use in current OBT and baseline HIV-1 RNA.||||||0.0009
72511995|NCT00243230|144554107|SUPERIORITY|||||||0.0038|||||||Cochran-Mantel-Haenszel|Cochran-Mantel Haenszel Test adjusted for stratification factors of T20 use in current OBT and baseline HIV-1 RNA.||||||0.0038
72511996|NCT00243230|144554108|SUPERIORITY|||||||0.0002|||||||Cochran-Mantel-Haenszel|Cochran-Mantel Haenszel Test adjusted for stratification factors of T20 use in current OBT and baseline HIV-1 RNA.||||||0.0002
72511997|NCT00243230|144554108|SUPERIORITY|||||||0.0004|||||||Cochran-Mantel-Haenszel|Cochran-Mantel Haenszel Test adjusted for stratification factors of T20 use in current OBT and baseline HIV-1 RNA.||||||0.0004
72511998|NCT03855137|144554152|SUPERIORITY||Least Squares Mean Difference|-2.41|STANDARD_ERROR_OF_MEAN|0.547||0.0001|TWO_SIDED|95.0|-3.48|-1.33||Adjusted p-value using graphical approach to control the overall type 1 error rate for multiple comparisons.|Mixed Model Repeated Measures (MMRM)||MMRM model=treatment group,visit,stratification by acute medication overuse,migraine prevention medication use and number of failures,region,and treatment group-by-visit as fixed factors and baseline and baseline-by-visit interaction as covariates.|||-1.33|-3.48|0.0001
72511999|NCT03855137|144554152|SUPERIORITY||Least Squares Mean Difference|-1.82|STANDARD_ERROR_OF_MEAN|0.545||0.0009|TWO_SIDED|95.0|-2.89|-0.75||Adjusted p-value using graphical approach to control the overall type 1 error rate for multiple comparisons.|MMRM||MMRM model=treatment group,visit,stratification by acute medication overuse,migraine prevention medication use and number of failures,region,and treatment group-by-visit as fixed factors and baseline and baseline-by-visit interaction as covariates.|||-0.75|-2.89|0.0009
72512000|NCT03855137|144554153|SUPERIORITY||Least Squares Mean Difference|-2.24|STANDARD_ERROR_OF_MEAN|0.547||0.0001|TWO_SIDED|95.0|-3.31|-1.16||Adjusted p-value using graphical approach to control the overall type 1 error rate for multiple comparisons.|MMRM||MMRM model=treatment group,visit,stratification by acute medication overuse,migraine prevention medication use and number of failures,region,and treatment group-by-visit as fixed factors and baseline and baseline-by-visit interaction as covariates.|||-1.16|-3.31|0.0001
72402346|NCT01480076|144311674|SUPERIORITY_OR_OTHER|||||||0.4027|||||||mixed effect model|||Month 9, Responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage overall work impairment due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.4027
72512001|NCT03855137|144554153|SUPERIORITY||Least Squares Mean Difference|-1.66|STANDARD_ERROR_OF_MEAN|0.544||0.0024|TWO_SIDED|95.0|-2.72|-0.59|||MMRM|Adjusted p-value using graphical approach to control the overall type 1 error rate for multiple comparisons.|MMRM model=treatment group,visit,stratification by acute medication overuse,migraine prevention medication use and number of failures,region,and treatment group-by-visit as fixed factors and baseline and baseline-by-visit interaction as covariates.|||-0.59|-2.72|0.0024
72512002|NCT03855137|144554154|SUPERIORITY||Least Squares Mean Difference|-2.32|STANDARD_ERROR_OF_MEAN|0.541||0.0001|TWO_SIDED|95.0|-3.38|-1.26||Adjusted p-value using graphical approach to control the overall type 1 error rate for multiple comparisons.|MMRM||MMRM model=treatment group,visit,stratification by acute medication overuse,migraine prevention medication use and number of failures,region,and treatment group-by-visit as fixed factors and baseline and baseline-by-visit interaction as covariates.|||-1.26|-3.38|0.0001
72402347|NCT01480076|144311674|SUPERIORITY_OR_OTHER|||||||0.1077|||||||mixed effect model|||Month 9, Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage overall work impairment due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.1077
72402348|NCT01480076|144311674|SUPERIORITY_OR_OTHER||least squares mean|13.5|STANDARD_ERROR_OF_MEAN|9.98||0.1781|TWO_SIDED||||||mixed effect model|||Month 9, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage overall work impairment due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.1781
72402349|NCT01480076|144311674|SUPERIORITY_OR_OTHER|||||||0.2422|||||||mixed effect model|||Month 12, Responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage overall work impairment due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.2422
72402350|NCT01480076|144311674|SUPERIORITY_OR_OTHER|||||||0.0994|||||||mixed effect model|||Month 12, Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage overall work impairment due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0994
72483731|NCT01009554|144494171|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.077|STANDARD_ERROR_OF_MEAN|0.0355||0.034|TWO_SIDED|95.0|0.006|0.147||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain area for the gingival region and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.147|0.006|0.034
72402351|NCT01480076|144311674|SUPERIORITY_OR_OTHER||least squares mean|8.8|STANDARD_ERROR_OF_MEAN|7.13||0.2194|TWO_SIDED||||||mixed effect model|||Month 12, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage overall work impairment due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.2194
72483732|NCT01009554|144494172|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.168|STANDARD_ERROR_OF_MEAN|0.0398|<|0.001|TWO_SIDED|95.0|0.089|0.247||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain area for the gingival region and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.247|0.089|<0.001
72483733|NCT01009554|144494173|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.193|STANDARD_ERROR_OF_MEAN|0.0516|<|0.001|TWO_SIDED|95.0|0.091|0.296||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain area for the gingival region and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.296|0.091|<0.001
72483734|NCT01009554|144494174|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.031||0.524|TWO_SIDED|95.0|-0.082|0.042||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain score for the body region and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.042|-0.082|0.524
72483735|NCT01009554|144494175|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.055|STANDARD_ERROR_OF_MEAN|0.0395||0.172|TWO_SIDED|95.0|-0.024|0.133||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain score for the body region and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.133|-0.024|0.172
72483736|NCT01009554|144494176|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.116|STANDARD_ERROR_OF_MEAN|0.0439||0.01|TWO_SIDED|95.0|0.028|0.203||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain score for the body region and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.203|0.028|0.010
72512003|NCT03855137|144554154|SUPERIORITY||Least Squares Mean Difference|-1.87|STANDARD_ERROR_OF_MEAN|0.538||0.0009|TWO_SIDED|95.0|-2.93|-0.81||Adjusted p-value using graphical approach to control the overall type 1 error rate for multiple comparisons.|MMRM||MMRM model=treatment group,visit,stratification by acute medication overuse,migraine prevention medication use and number of failures,region,and treatment group-by-visit as fixed factors and baseline and baseline-by-visit interaction as covariates.|||-0.81|-2.93|0.0009
72512004|NCT03855137|144554155|SUPERIORITY||Least Squares Mean Difference|-2.14|STANDARD_ERROR_OF_MEAN|0.539||0.0002|TWO_SIDED|95.0|-3.2|-1.09||Adjusted p-value using graphical approach to control the overall type 1 error rate for multiple comparisons.|MMRM||MMRM model=treatment group,visit,stratification by acute medication overuse,migraine prevention medication use and number of failures,region,and treatment group-by-visit as fixed factors and baseline and baseline-by-visit interaction as covariates.|||-1.09|-3.20|0.0002
72567272|NCT01763918|144665508|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-19.59|STANDARD_ERROR_OF_MEAN|4.22|<|0.001|TWO_SIDED|95.0|-27.92|-11.26||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C and ezetimibe use, scheduled visit, and the interaction of treatment with scheduled visit.||||-11.26|-27.92|<0.001
72402352|NCT01480076|144311675|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Overall, Responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of regular activity productivity loss due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
72512005|NCT03855137|144554155|SUPERIORITY||Least Squares Mean Difference|-1.72|STANDARD_ERROR_OF_MEAN|0.536||0.0024|TWO_SIDED|95.0|-2.78|-0.67||Adjusted p-value using graphical approach to control the overall type 1 error rate for multiple comparisons.|MMRM||MMRM model=treatment group,visit,stratification by acute medication overuse,migraine prevention medication use and number of failures,region,and treatment group-by-visit as fixed factors and baseline and baseline-by-visit interaction as covariates.|||-0.67|-2.78|0.0024
72512006|NCT03855137|144554156|SUPERIORITY||Least Squares Mean Difference|-2.63|STANDARD_ERROR_OF_MEAN|0.51||0.0001|TWO_SIDED|95.0|-3.63|-1.63||Adjusted p-value using graphical approach to control the overall type 1 error rate for multiple comparisons.|MMRM||MMRM model=treatment group,visit,stratification by acute medication overuse,migraine prevention medication use and number of failures,region,and treatment group-by-visit as fixed factors and baseline and baseline-by-visit interaction as covariates.|||-1.63|-3.63|0.0001
72512007|NCT03855137|144554156|SUPERIORITY||Least Squares Mean Difference|-2.13|STANDARD_ERROR_OF_MEAN|0.508||0.0009|TWO_SIDED|95.0|-3.13|-1.13||Adjusted p-value using graphical approach to control the overall type 1 error rate for multiple comparisons.|MMRM||MMRM model=treatment group,visit,stratification by acute medication overuse,migraine prevention medication use and number of failures,region,and treatment group-by-visit as fixed factors and baseline and baseline-by-visit interaction as covariates.|||-1.13|-3.13|0.0009
72512008|NCT03855137|144554157|SUPERIORITY||Least Squares Mean Difference|-2.52|STANDARD_ERROR_OF_MEAN|0.507||0.0002|TWO_SIDED|95.0|-3.52|-1.53||Adjusted p-value using graphical approach to control the overall type 1 error rate for multiple comparisons.|MMRM||MMRM model=treatment group,visit,stratification by acute medication overuse,migraine prevention medication use and number of failures,region,and treatment group-by-visit as fixed factors and baseline and baseline-by-visit interaction as covariates.|||-1.53|-3.52|0.0002
72512009|NCT03855137|144554157|SUPERIORITY||Least Squares Mean Difference|-2.09|STANDARD_ERROR_OF_MEAN|0.505||0.0024|TWO_SIDED|95.0|-3.09|-1.1|||MMRM|||||-1.10|-3.09|0.0024
72512010|NCT03855137|144554158|SUPERIORITY||Odds Ratio (OR)|2.13||||0.0003|TWO_SIDED|95.0|1.45|3.14||Adjusted p-value using graphical approach to control the overall type 1 error rate for multiple comparisons.|Logistic regression||Logistic regression for each atogepant group versus placebo with baseline monthly migraine days as covariate,stratification of region,acute medication overuse,migraine prevention medication and number of failures,treatment group as fixed factors.|||3.14|1.45|0.0003
72512011|NCT03855137|144554158|SUPERIORITY||Odds Ratio (OR)|2.04||||0.0009|TWO_SIDED|95.0|1.38|3.0||Adjusted p-value using graphical approach to control the overall type 1 error rate for multiple comparisons.|Logistic regression||Logistic regression for each atogepant group versus placebo with baseline monthly migraine days as covariate,stratification of region,acute medication overuse,migraine prevention medication and number of failures,treatment group as fixed factors.|||3.00|1.38|0.0009
72567273|NCT01763918|144665508|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-11.56|STANDARD_ERROR_OF_MEAN|4.97|<|0.001|TWO_SIDED|95.0|-21.38|-1.74||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C and ezetimibe use, scheduled visit, and the interaction of treatment with scheduled visit.||||-1.74|-21.38|<0.001
72567274|NCT01763918|144665509|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|8.38|STANDARD_ERROR_OF_MEAN|2.04|<|0.001|TWO_SIDED|95.0|4.36|12.4||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C and ezetimibe use, scheduled visit, and the interaction of treatment with scheduled visit.||||12.40|4.36|<0.001
72567275|NCT01763918|144665509|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|9.48|STANDARD_ERROR_OF_MEAN|2.21|<|0.001|TWO_SIDED|95.0|5.1|13.85||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C and ezetimibe use, scheduled visit, and the interaction of treatment with scheduled visit.||||13.85|5.10|<0.001
72567276|NCT01763918|144665510|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|9.2|STANDARD_ERROR_OF_MEAN|2.3|<|0.001|TWO_SIDED|95.0|4.66|13.74||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C and ezetimibe use, scheduled visit, and the interaction of treatment with scheduled visit.||||13.74|4.66|<0.001
72567277|NCT01763918|144665510|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|9.07|STANDARD_ERROR_OF_MEAN|2.83|<|0.001|TWO_SIDED|95.0|3.48|1466.0||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C and ezetimibe use, scheduled visit, and the interaction of treatment with scheduled visit.||||1466|3.48|<0.001
72567278|NCT01763918|144665511|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-22.63|STANDARD_ERROR_OF_MEAN|3.46|<|0.001|TWO_SIDED|95.0|-29.46|-15.81||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C and ezetimibe use, scheduled visit, and the interaction of treatment with scheduled visit.||||-15.81|-29.46|<0.001
72567279|NCT01763918|144665511|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-15.54|STANDARD_ERROR_OF_MEAN|3.9|<|0.001|TWO_SIDED|95.0|-23.25|-7.84||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C and ezetimibe use, scheduled visit, and the interaction of treatment with scheduled visit.||||-7.84|-23.25|<0.001
72512012|NCT03855137|144554159|SUPERIORITY||Odds Ratio (OR)|2.03||||0.0006|TWO_SIDED|95.0|1.38|2.98||Adjusted p-value using graphical approach to control the overall type 1 error rate for multiple comparisons.|Logistic regression||Logistic regression for each atogepant group versus placebo with baseline monthly migraine days as covariate,stratification of region,acute medication overuse,migraine prevention medication and number of failures,treatment group as fixed factors.|||2.98|1.38|0.0006
72402353|NCT01480076|144311675|SUPERIORITY_OR_OTHER|||||||0.086|||||||mixed effect model|||Overall, Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of regular activity productivity loss due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0860
72402354|NCT01480076|144311675|SUPERIORITY_OR_OTHER||least squares mean|-7.3|STANDARD_ERROR_OF_MEAN|2.2||0.001|TWO_SIDED||||||mixed effect model|||Overall, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of regular activity productivity loss due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0010
72402355|NCT01480076|144311675|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 3, Responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of regular activity productivity loss due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
72402356|NCT01480076|144311675|SUPERIORITY_OR_OTHER|||||||0.2777|||||||mixed effect model|||Month 3, Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of regular activity productivity loss due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.2777
72483737|NCT01009554|144494177|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.014|STANDARD_ERROR_OF_MEAN|0.0145||0.348|TWO_SIDED|95.0|-0.043|0.015||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain intensity for the body region and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.015|-0.043|0.348
72483738|NCT01009554|144494178|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.025|STANDARD_ERROR_OF_MEAN|0.0186||0.185|TWO_SIDED|95.0|-0.012|0.062||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain intensity for the body region and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.062|-0.012|0.185
72483739|NCT01009554|144494179|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.049|STANDARD_ERROR_OF_MEAN|0.0196||0.014|TWO_SIDED|95.0|0.01|0.088||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain intensity for the body region and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.088|0.010|0.014
72483740|NCT01009554|144494180|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.008|STANDARD_ERROR_OF_MEAN|0.016||0.623|TWO_SIDED|95.0|-0.04|0.024||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain area for the body region and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.024|-0.040|0.623
72512013|NCT03855137|144554159|SUPERIORITY||Odds Ratio (OR)|1.9||||0.0009|TWO_SIDED|95.0|1.29|2.79||Adjusted p-value using graphical approach to control the overall type 1 error rate for multiple comparisons.|Logistic regression||Logistic regression for each atogepant group versus placebo with baseline monthly migraine days as covariate,stratification of region,acute medication overuse,migraine prevention medication and number of failures,treatment group as fixed factors.|||2.79|1.29|0.0009
72512014|NCT03855137|144554160|SUPERIORITY||Least Squares Mean Difference|7.43|STANDARD_ERROR_OF_MEAN|1.864||0.0006|TWO_SIDED|95.0|3.77|11.09||Adjusted p-value using graphical approach to control the overall type 1 error rate for multiple comparisons.|MMRM||MMRM model=treatment group,visit,stratification by acute medication overuse,migraine prevention medication use and number of failures,region,and treatment group-by-visit as fixed factors and baseline and baseline-by-visit interaction as covariates.|||11.09|3.77|0.0006
72402357|NCT01480076|144311675|SUPERIORITY_OR_OTHER||least squares mean|-10.4|STANDARD_ERROR_OF_MEAN|2.76||0.0002|TWO_SIDED||||||mixed effect model|||Month 3, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of regular activity productivity loss due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0002
72483741|NCT01009554|144494181|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.024|STANDARD_ERROR_OF_MEAN|0.0186||0.192|TWO_SIDED|95.0|-0.013|0.061||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain area for the body region and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.061|-0.013|0.192
72483742|NCT01009554|144494182|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.057|STANDARD_ERROR_OF_MEAN|0.0213||0.009|TWO_SIDED|95.0|0.014|0.099||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain area for the body region and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.099|0.014|0.009
72402358|NCT01480076|144311675|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 6, Responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of regular activity productivity loss due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
72567280|NCT01763918|144665512|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-20.97|STANDARD_ERROR_OF_MEAN|4.21|<|0.001|TWO_SIDED|95.0|-29.29|-12.66||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C and ezetimibe use, scheduled visit, and the interaction of treatment with scheduled visit.||||-12.66|-29.29|<0.001
72567281|NCT01763918|144665512|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-9.17|STANDARD_ERROR_OF_MEAN|4.98|<|0.001|TWO_SIDED|95.0|-19.01|0.68||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C and ezetimibe use, scheduled visit, and the interaction of treatment with scheduled visit.||||0.68|-19.01|<0.001
72567282|NCT05528861|144665534|SUPERIORITY||LSM Difference from Placebo|0.5|STANDARD_ERROR_OF_MEAN|2.1||0.8174|TWO_SIDED|95.0|-3.6|4.5|||ANCOVA|||||4.5|-3.6|0.8174
72567283|NCT05528861|144665535|SUPERIORITY||LSM Difference from Placebo|0.6|STANDARD_ERROR_OF_MEAN|1.1||0.5857|TWO_SIDED|95.0|-1.6|2.8|||Mixed Models Analysis|||||2.8|-1.6|0.5857
72402359|NCT01480076|144311675|SUPERIORITY_OR_OTHER|||||||0.1078|||||||mixed effect model|||Month 6, Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of regular activity productivity loss due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.1078
72402360|NCT01480076|144311675|SUPERIORITY_OR_OTHER||least squares mean|-7.6|STANDARD_ERROR_OF_MEAN|2.87||0.0082|TWO_SIDED||||||mixed effect model|||Month 6, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of regular activity productivity loss due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0082
72402361|NCT01480076|144311675|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 9, Responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of regular activity productivity loss due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
72567284|NCT05528861|144665536|SUPERIORITY||LSM Difference from Placebo|-0.1|STANDARD_ERROR_OF_MEAN|1.1||0.9633|TWO_SIDED|95.0|-2.2|2.1|||Mixed Models Analysis|||||2.1|-2.2|0.9633
72567285|NCT05528861|144665537|SUPERIORITY||Risk Difference (RD)|6.25||||0.1201|TWO_SIDED|95.0|-11.4|23.78|||Fisher Exact|||||23.78|-11.40|0.1201
72402362|NCT01480076|144311675|SUPERIORITY_OR_OTHER|||||||0.1838|||||||mixed effect model|||Month 9, Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of regular activity productivity loss due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.1838
72402363|NCT01480076|144311675|SUPERIORITY_OR_OTHER||least squares mean|-6.3|STANDARD_ERROR_OF_MEAN|3.02||0.0364|TWO_SIDED||||||mixed effect model|||Month 9, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of regular activity productivity loss due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0364
72402364|NCT01480076|144311675|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 12, Responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of regular activity productivity loss due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
72402365|NCT01480076|144311675|SUPERIORITY_OR_OTHER|||||||0.1714|||||||mixed effect model|||Month 12, Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of regular activity productivity loss due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.1714
72567286|NCT01602172|144665540|EQUIVALENCE|Results of the regression models were used to reject null hypotheses of equivalence with p-values of comparisons across groups in changes in alcohol related measures using p-values \< 0.05 as significant.||||||0.05||||||First, significance of the regression model was viewed. When the overall model was significant, tests of the co-efficients were viewed. Primary effects of interest were the treatment group X time interactions.|Mixed Models Analysis|||Measures were compared with linear mixed effects regression models to compare impact of BI compared to usual care conditions. Analyses reported here included only those that completed the 6 month interview (71/82 baseline participants).||||.05
72567287|NCT00518882|144665545|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority concluded if upper confidence interval of test is below 0.4%|Estimated treatment difference, LS Mean|-0.33|||<|0.0001||95.0|-0.47|-0.18||No multiplicity concerns|ANCOVA|||"ANCOVA with treatment, country and previous OAD treatment as fixed effects and baseline HbA1c as covariate.~2 hypotheses were tested: H01: µliraglutide ≥ µexenatide + Δ, HA1: µliraglutide \< µexenatide + Δ; Δ=0.4%. If non-inferiority was concluded, a test for superiority was established by a 1-sided test of the hypothesis H02: µliraglutide ≥ µexenatide against HA2: µliraglutide \< µexenatide. Superiority was concluded if the upper limit of the 2-sided 95% CI for the difference was below 0%."||-0.18|-0.47|<.0001
72567288|NCT00518882|144665546|SUPERIORITY_OR_OTHER||Mean|0.25|STANDARD_DEVIATION|0.803|<|0.0001||95.0|0.139|0.364|||Paired t-test|||A paired t test was made within the treatment group and 95% confidence intervals for the difference between Weeks 26 and 78 were constructed. H0 was µ78 - µ26 = 0 against HA: µ78 - µ26 ≠ 0. A difference between the two means (Week 26 and Week 78) was concluded when H0 was rejected at the 5% level.||0.364|0.139|<0.0001
72567289|NCT00518882|144665546|SUPERIORITY_OR_OTHER||Mean|0.0|STANDARD_DEVIATION|0.924||0.9872||95.0|-1.36|0.134|||Paired t-test|||A paired t test was made within the treatment group and 95% confidence intervals for the difference between Weeks 26 and 78 were constructed. H0 was µ78 - µ26 = 0 against HA: µ78 - µ26 ≠ 0. A difference between the two means (Week 26 and Week 78) was concluded when H0 was rejected at the 5% level.||0.134|-1.36|0.9872
72483743|NCT01009554|144494183|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.005|STANDARD_ERROR_OF_MEAN|0.0384||0.893|TWO_SIDED|95.0|-0.081|0.071||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain score for the facial region and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.071|-0.081|0.893
72483744|NCT01009554|144494184|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.021|STANDARD_ERROR_OF_MEAN|0.0476||0.655|TWO_SIDED|95.0|-0.073|0.116||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain score for the facial region and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.116|-0.073|0.655
72483745|NCT01009554|144494185|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.222|STANDARD_ERROR_OF_MEAN|0.0693||0.002|TWO_SIDED|95.0|0.084|0.359||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain score for the facial region and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.359|0.084|0.002
72483746|NCT01009554|144494186|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.002|STANDARD_ERROR_OF_MEAN|0.0187||0.914|TWO_SIDED|95.0|-0.039|0.035||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain intensity for the facial region and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.035|-0.039|0.914
72483747|NCT01009554|144494187|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.011|STANDARD_ERROR_OF_MEAN|0.0229||0.646|TWO_SIDED|95.0|-0.035|0.056||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain intensity for the facial region and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.056|-0.035|0.646
72483748|NCT01009554|144494188|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.102|STANDARD_ERROR_OF_MEAN|0.0309||0.001|TWO_SIDED|95.0|0.04|0.163||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain intensity for the facial region and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.163|0.040|0.001
72512015|NCT03855137|144554160|SUPERIORITY||Least Squares Mean Difference|5.78|STANDARD_ERROR_OF_MEAN|1.848||0.0024|TWO_SIDED|95.0|2.15|9.41||Adjusted p-value using graphical approach to control the overall type 1 error rate for multiple comparisons.|MMRM||MMRM model=treatment group,visit,stratification by acute medication overuse,migraine prevention medication use and number of failures,region,and treatment group-by-visit as fixed factors and baseline and baseline-by-visit interaction as covariates.|||9.41|2.15|0.0024
72512016|NCT03855137|144554161|SUPERIORITY||Least Squares Mean Difference|-4.85|STANDARD_ERROR_OF_MEAN|0.968||0.0003|TWO_SIDED|95.0|-6.75|-2.95||Adjusted p-value using graphical approach to control the overall type 1 error rate for multiple comparisons.|MMRM||MMRM model=treatment group,visit,stratification by acute medication overuse,migraine prevention medication use and number of failures,region,and treatment group-by-visit as fixed factors and baseline and baseline-by-visit interaction as covariates.|||-2.95|-6.75|0.0003
72512017|NCT03855137|144554161|SUPERIORITY||Least Squares Mean Difference|-3.38|STANDARD_ERROR_OF_MEAN|0.963||0.0009|TWO_SIDED|95.0|-5.27|-1.49||Adjusted p-value using graphical approach to control the overall type 1 error rate for multiple comparisons.|MMRM||MMRM model=treatment group,visit,stratification by acute medication overuse,migraine prevention medication use and number of failures,region,and treatment group-by-visit as fixed factors and baseline and baseline-by-visit interaction as covariates.|||-1.49|-5.27|0.0009
72567290|NCT00518882|144665547|SUPERIORITY_OR_OTHER||Mean|-0.98|STANDARD_DEVIATION|1.119|<|0.0001||95.0|-1.137|-0.823|||Paired t-test|||The analysis was made with a paired t test within the treatment group and 95% confidence intervals for the difference between Weeks 0 and 78 were constructed. H0 was µ78 - µ0 = 0 against HA: µ78 - µ0 ≠ 0. A difference between the two means (Weeks 0 and 78) was concluded when H0 was rejected at the 5% level.||-0.823|-1.137|<0.0001
72483749|NCT01009554|144494189|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.002|STANDARD_ERROR_OF_MEAN|0.0179||0.93|TWO_SIDED|95.0|-0.034|0.037||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain area for the facial region and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.037|-0.034|0.930
72483750|NCT01009554|144494190|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.016|STANDARD_ERROR_OF_MEAN|0.0224||0.486|TWO_SIDED|95.0|-0.029|0.06||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain area for the facial region and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.060|-0.029|0.486
72483751|NCT01009554|144494191|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.112|STANDARD_ERROR_OF_MEAN|0.0338||0.001|TWO_SIDED|95.0|0.045|0.18||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain area for the facial region and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.180|0.045|0.001
72512018|NCT03855137|144554162|SUPERIORITY||Least Squares Mean Difference|-4.19|STANDARD_ERROR_OF_MEAN|0.897||0.0003|TWO_SIDED|95.0|-5.95|-2.43||Adjusted p-value using graphical approach to control the overall type 1 error rate for multiple comparisons.|MMRM||MMRM model=treatment group,visit,stratification by acute medication overuse,migraine prevention medication use and number of failures,region,and treatment group-by-visit as fixed factors and baseline and baseline-by-visit interaction as covariates.|||-2.43|-5.95|0.0003
72483752|NCT01009554|144494192|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.12|STANDARD_ERROR_OF_MEAN|0.1006||0.237|TWO_SIDED|95.0|-0.08|0.32||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain score for the lingual region and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.320|-0.080|0.237
72483753|NCT01009554|144494193|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.521|STANDARD_ERROR_OF_MEAN|0.112|<|0.001|TWO_SIDED|95.0|0.298|0.743||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain score for the lingual region and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.743|0.298|<0.001
72483754|NCT01009554|144494194|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.567|STANDARD_ERROR_OF_MEAN|0.1367|<|0.001|TWO_SIDED|95.0|0.295|0.839||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain score for the lingual region and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.839|0.295|<0.001
72483755|NCT01009554|144494195|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.062|STANDARD_ERROR_OF_MEAN|0.0491||0.21|TWO_SIDED|95.0|-0.036|0.16||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain intensity for the lingual region and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.160|-0.036|0.210
72483756|NCT01009554|144494196|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.262|STANDARD_ERROR_OF_MEAN|0.055|<|0.001|TWO_SIDED|95.0|0.153|0.372||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain intensity for the lingual region and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.372|0.153|<0.001
72483757|NCT01009554|144494197|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.281|STANDARD_ERROR_OF_MEAN|0.0654|<|0.001|TWO_SIDED|95.0|0.151|0.411||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain intensity for the lingual region and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.411|0.151|<0.001
72483758|NCT01009554|144494198|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.066|STANDARD_ERROR_OF_MEAN|0.0496||0.187|TWO_SIDED|95.0|-0.033|0.165||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain area for the lingual region and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.165|-0.033|0.187
72483759|NCT01009554|144494199|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.256|STANDARD_ERROR_OF_MEAN|0.0544|<|0.001|TWO_SIDED|95.0|0.148|0.364||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain area for the lingual region and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.364|0.148|<0.001
72512019|NCT03855137|144554162|SUPERIORITY||Least Squares Mean Difference|-2.71|STANDARD_ERROR_OF_MEAN|0.893||0.0025|TWO_SIDED|95.0|-4.47|-0.96||Adjusted p-value using graphical approach to control the overall type 1 error rate for multiple comparisons.|MMRM||MMRM model=treatment group,visit,stratification by acute medication overuse,migraine prevention medication use and number of failures,region,and treatment group-by-visit as fixed factors and baseline and baseline-by-visit interaction as covariates.|||-0.96|-4.47|0.0025
72512020|NCT03855137|144554163|SUPERIORITY||Least Squares Mean Difference|-3.3|STANDARD_ERROR_OF_MEAN|0.697||0.0006|TWO_SIDED|95.0|-4.67|-1.93|||MMRM||MMRM model=treatment group,visit,stratification by acute medication overuse,migraine prevention medication use and number of failures,region,and treatment group-by-visit as fixed factors and baseline and baseline-by-visit interaction as covariates.|||-1.93|-4.67|0.0006
72512021|NCT03855137|144554163|SUPERIORITY||Least Squares Mean Difference|-2.66|STANDARD_ERROR_OF_MEAN|0.69||0.0024|TWO_SIDED|95.0|-4.02|-1.3|||MMRM||MMRM model=treatment group,visit,stratification by acute medication overuse,migraine prevention medication use and number of failures,region,and treatment group-by-visit as fixed factors and baseline and baseline-by-visit interaction as covariates.|||-1.30|-4.02|0.0024
72512022|NCT02065622|144554181|SUPERIORITY||Adjusted risk difference|2.5||||0.269|TWO_SIDED|95.0|-2.0|7.0|||Cochran-Mantel-Haenszel||Risk difference = (adalimumab higher induction dose - adalimumab standard induction dose).|Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel test adjusted for previous infliximab use and baseline corticosteroid use.||7.0|-2.0|0.269
72567291|NCT00518882|144665547|SUPERIORITY_OR_OTHER||Mean|-0.85|STANDARD_DEVIATION|1.105|<|0.0001||95.0|-1.01|-0.687|||Paired t-test|||The analysis was made with a paired t test within the exenatide→liraglutide group and 95% confidence intervals for the difference between Weeks 0 and 78 were constructed. H0 was µ78 - µ0 = 0 against HA: µ78 - µ0 ≠ 0. A difference between the two means (Weeks 0 and 78) was concluded when H0 was rejected at the 5% level.||-0.687|-1.010|<0.0001
72567292|NCT00518882|144665550|SUPERIORITY_OR_OTHER||Estimated treatment difference, LS Mean|-0.38||||0.2235||95.0|-0.99|0.23||There were no multiplicity concerns.|ANCOVA|||ANCOVA model included treatment, country and previous treatment as fixed effects and baseline body weight as covariate. The objective was to demonstrate that treatment with liraglutide was different from treatment with exenatide. Thus the null hypothesis and its alternative were H0: µliraglutide = µexenatide against HA1:µliraglutide ≠ µexenatide where µliraglutide and µexenatide is the mean value of the body weight in the liraglutide arm and exenatide arm, respectively.||0.23|-0.99|0.2235
72512023|NCT02065622|144554181|SUPERIORITY|||||||0.447|||||||Breslow-Day test|Breslow-Day test of homogeneity across strata.||||||0.447
72483760|NCT01009554|144494200|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.273|STANDARD_ERROR_OF_MEAN|0.0669|<|0.001|TWO_SIDED|95.0|0.14|0.406||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain area for the lingual region and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.406|0.140|<0.001
72483761|NCT01405937|144494206|SUPERIORITY_OR_OTHER||||||<|0.001||||||The Type-I error rate over the multiple tests comparisons was controlled by the Hochberg testing procedure.|exact test for binomial proportion|||The null hypothesis that the percentage of participants achieving SVR24 of vaniprevir treatment was 20% versus the alternative that the percentage of participants achieving SVR24 of vaniprevir treatment was over 20% was tested.||||<0.001
72483762|NCT01405937|144494206|SUPERIORITY_OR_OTHER||||||<|0.001||||||The Type-I error rate over the multiple tests comparisons was controlled by the Hochberg testing procedure.|exact test for binomial proportion|||The null hypothesis that the percentage of participants achieving SVR24 of vaniprevir treatment was 20% versus the alternative that the percentage of participants achieving SVR24 of vaniprevir treatment was over 20% was tested.||||<0.001
72483763|NCT03231943|144494297|OTHER||Power model|0.9476|||||TWO_SIDED|90.0|0.8982|0.9971|||||The statistical model (power model) is based on the PK parameters (AUC0-inf) from all active doses in Part 1|||0.9971|0.8982|
72483764|NCT03231943|144494298|OTHER||Power model|0.928|||||TWO_SIDED|90.0|0.8877|0.9683|||||The statistical model (power model) is based on the PK parameters (AUC0-24) from all active doses in Part 1|||0.9683|0.8877|
72483765|NCT03231943|144494299|OTHER||Power Model|0.9352|||||TWO_SIDED|90.0|0.897|0.9734|||||The statistical model (power model) is based on the PK parameters (Cmax) from all active doses in Part 1|||0.9734|0.8970|
72483766|NCT03231943|144494300|OTHER||Power model|0.7968|||||TWO_SIDED|90.0|0.6424|0.9512|||||The statistical model (power model) is based on the PK parameters (AUC0-tau) from all active doses in Part 1|||0.9512|0.6424|
72483767|NCT03231943|144494301|OTHER||Power model|0.789|||||TWO_SIDED|90.0|0.6149|0.9631|||||The statistical model (power model) is based on the PK parameters (Ctrough) from all active doses in Part 2|||0.9631|0.6149|
72483768|NCT03231943|144494302|OTHER||Power model|0.7955|||||TWO_SIDED|90.0|0.6562|0.9349|||||The statistical model (power model) is based on the PK parameters (Cmax) from all active doses in Part 2|||0.9349|0.6562|
72483769|NCT03231943|144494307|OTHER||Power model|0.737|||||TWO_SIDED|90.0|0.5649|0.9091|||||The statistical model (power model) is based on the PK parameters (Cmax) from all active doses in Part 2|||0.9091|0.5649|
72567293|NCT00518882|144665551|SUPERIORITY_OR_OTHER||Mean|-0.4|STANDARD_DEVIATION|3.24||0.0793||95.0|-0.86|0.05|||Paired t test|||The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 26 and 78 were constructed. H0 was µ78 - µ26=0 against HA: µ78 - µ26 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.||0.05|-0.86|0.0793
72483770|NCT03231943|144494308|OTHER||Power model|0.7397|||||TWO_SIDED|90.0|0.5576|0.9218|||||The statistical model (power model) is based on the PK parameters (AUC0-24) from all active doses in Part 2|||0.9218|0.5576|
72567294|NCT00518882|144665551|SUPERIORITY_OR_OTHER||Mean|-0.7|STANDARD_DEVIATION|3.67||0.0075||95.0|-1.26|-0.2|||Paired t test|||A paired t test was made within the group and 95% confidence intervals for the difference between Weeks 26 and 78 were constructed. H0 was µ78 - µ26 = 0 against HA: µ78 - µ26 ≠ 0. A difference between the two means (Week 26 and Week 78) was concluded when H0 was rejected at the 5% level.||-0.20|-1.26|0.0075
72483771|NCT05564299|144494309|OTHER|||||||0.053|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon rank sum test||||0.053
72483772|NCT02960113|144494339|OTHER|||||||0.98||||||Bonferroni-adjusted P-value, calculated as two times the nominal p-value because there are two primary outcomes|Chi-squared|d.f.=2||Null hypothesis: Percent experiencing nausea equal between groups||||0.98
72483773|NCT02960113|144494340|OTHER|||||||0.9||||||Bonferroni-adjusted P-value, calculated as two times the nominal p-value because there are two primary outcomes|Chi-squared|d.f.=2||Null hypothesis: Percent experiencing vomiting equal across groups||||0.90
72483774|NCT02960113|144494341|OTHER|Null hypothesis: Mean scores equal across treatment groups||||||0.026|||||||ANOVA|||||||0.026
72483775|NCT02960113|144494342|OTHER|Null hypothesis: means equal across treatment groups||||||0.91|||||||ANOVA|||||||0.91
72483776|NCT02960113|144494343|OTHER|||||||0.8|||||||ANOVA|||Null hypothesis: means equal across treatment groups||||0.80
72483777|NCT02960113|144494344|OTHER|||||||0.82|||||||ANOVA|||Null hypothesis: means equal across treatment groups||||0.82
72483778|NCT02960113|144494345|OTHER|||||||0.93|||||||ANOVA|||Null hypothesis: means equal across treatment groups||||0.93
72483779|NCT02960113|144494346|OTHER|Null hypothesis: percent of vomiting equal across treatment groups||||||0.55|||||||Chi-squared|d.f.=2||||||0.55
72483780|NCT02960113|144494347|OTHER|||||||0.71|||||||Chi-squared|d.f.=2||Null hypothesis: percent of vomiting equal across treatment groups||||0.71
72483781|NCT02960113|144494348|OTHER|||||||0.55|||||||Chi-squared|d.f.=2||Null hypothesis: percent of vomiting equal across treatment groups||||0.55
72483782|NCT02960113|144494349|OTHER|||||||0.2|||||||Chi-squared|d.f.=2||Null hypothesis: percent of vomiting equal across treatment groups||||0.20
72483783|NCT03434353|144494351|OTHER||Percentage Difference|-2.0|||||TWO_SIDED|95.0|-30.4|26.4|||||The percentage difference (Group 1 - Group 2) \& corresponding 2-sided 95% confidence interval (CI) were calculated by using stratum-adjusted Mantel-Haenszel proportions, stratified by baseline hepatitis B e antigen (HBeAg) status (positive,negative).|||26.4|-30.4|
72483784|NCT03434353|144494351|OTHER||Percentage Difference|-24.7|||||TWO_SIDED|95.0|-49.2|-0.2|||||The percentage difference (Group 3 - Group 2) and the corresponding 2-sided 95% CI were calculated by using stratum-adjusted Mantel-Haenszel proportions, stratified by baseline HBeAg status (positive, negative).|||-0.2|-49.2|
72483785|NCT03434353|144494351|OTHER||Percentage Difference|-17.8|||||TWO_SIDED|95.0|-43.7|8.2|||||The percentage difference (Group 5 - Group 2) and the corresponding 2-sided 95% CI were calculated by using stratum-adjusted Mantel-Haenszel proportions, stratified by baseline HBeAg status (positive, negative).|||8.2|-43.7|
72483786|NCT03434353|144494353|OTHER||Percentage Difference|-16.6|||||TWO_SIDED|95.0|-37.7|4.4|||||The percentage difference (Group 1 - Group 2) and the corresponding 2-sided 95% CI were calculated by using stratum-adjusted Mantel-Haenszel proportions, stratified by baseline HBeAg status (positive, negative).|||4.4|-37.7|
72483787|NCT03434353|144494353|OTHER||Percentage Difference|-16.9|||||TWO_SIDED|95.0|-38.1|4.3|||||The percentage difference (Group 3 - Group 2) and the corresponding 2-sided 95% CI were calculated by using stratum-adjusted Mantel-Haenszel proportions, stratified by baseline HBeAg status (positive, negative).|||4.3|-38.1|
72402366|NCT01480076|144311675|SUPERIORITY_OR_OTHER||least squares mean|-4.8|STANDARD_ERROR_OF_MEAN|3.14||0.1259|TWO_SIDED||||||mixed effect model|||Month 12, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of regular activity productivity loss due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.1259
72402367|NCT01480076|144311676|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Overall, RRMS. Mixed effect model for repeated measures with visit, baseline PCS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
72567295|NCT00518882|144665552|SUPERIORITY_OR_OTHER||Mean|-3.3|STANDARD_DEVIATION|4.63|<|0.0001||95.0|-3.9|-2.61|||Paired t test|||The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 0 and 78 were constructed. H0 was µ78- µ0=0 against HA: µ78 - µ0 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.||-2.61|-3.90|<0.0001
72567296|NCT00518882|144665552|SUPERIORITY_OR_OTHER||Mean|-3.2|STANDARD_DEVIATION|4.44|<|0.0001||95.0|-3.85|-2.55|||Paired t test|||The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 0 and 78 were constructed. H0 was µ78- µ0=0 against HA: µ78 - µ0 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.||-2.55|-3.85|<0.0001
72576866|NCT00261443|144680664|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.33||||0.063|TWO_SIDED|95.0|-0.68|0.02||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 36 Comparison||0.02|-0.68|0.063
72402368|NCT01480076|144311676|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Overall, SPMS. Mixed effect model for repeated measures with visit, baseline PCS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
72402369|NCT01480076|144311676|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Overall, PPMS. Mixed effect model for repeated measures with visit, baseline PCS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
72402370|NCT01480076|144311676|SUPERIORITY_OR_OTHER|||||||0.0004|||||||mixed effect model|||Overall, PRMS. Mixed effect model for repeated measures with visit, baseline PCS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.0004
72483788|NCT03434353|144494353|OTHER||Percentage Difference|-16.7|||||TWO_SIDED|95.0|-37.9|4.4|||||The percentage difference (Group 5 - Group 2) and the corresponding 2-sided 95% CI were calculated by using stratum-adjusted Mantel-Haenszel proportions, stratified by baseline HBeAg status (positive, negative).|||4.4|-37.9|
72483789|NCT00148954|144494400|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.34||||0.003|TWO_SIDED|95.0|1.11|1.62|||Regression, Cox|||||1.62|1.11|0.003
72483790|NCT02021292|144494452|SUPERIORITY||ratio of geometric means|0.84||||0.041|TWO_SIDED|95.0|0.7|0.99|||ANCOVA|ANCOVA model on log-transformed % of baseline PVR at Week 16 adjusted by treatment as a factor and log transformed PVR at baseline as a covariate.||The null hypothesis (change of PVR at rest in Week 16 in percent of baseline PVR in subjects treated with placebo or macitentan is the same) is tested on the primary endpoint by means of an analysis of covariance (ANCOVA) model on the log(e) transformed % of baseline PVR at rest at Week 16.||0.99|0.70|0.0410
72483791|NCT02021292|144494453|SUPERIORITY||least squares (LS) mean difference|34.04||||0.0326|TWO_SIDED|95.0|2.9|65.2||To control multiplicity across all endpoints, secondary endpoints were analyzed in sequence using hierarchical approach based on order and significance as pre-specified in protocol eliminating further adjustment for multiple comparisons.|ANCOVA|||The null hypothesis is that the mean change from baseline in 6MWD at Week 24 is the same in the placebo and the macitentan group. Statistical model is ANCOVA including 6MWD at baseline as a covariate, with treatment as factor in the model.||65.2|2.9|0.0326
72483792|NCT02021292|144494454|SUPERIORITY||least squares (LS) mean difference|-0.39||||0.3492|TWO_SIDED|95.0|-1.21|0.43||To control multiplicity across all endpoints, secondary endpoints were analyzed in sequence using hierarchical approach based on order and significance as pre-specified in protocol eliminating further adjustment for multiple comparisons.|ANCOVA|||The null hypothesis is that the mean change from baseline is the same in the placebo and the macitentan group. Statistical model is Analysis of Covariance including Borg dyspnea index at baseline as a covariate, with Treatment as factor in the model.||0.43|-1.21|0.3492
72483793|NCT02021292|144494455|SUPERIORITY||Odds Ratio (OR)|0.212||||0.0962|TWO_SIDED|95.0|0.001|1.464||To control multiplicity across all endpoints, secondary endpoints were analyzed in sequence using hierarchical approach based on order and significance as pre-specified in protocol eliminating further adjustment for multiple comparisons.|ANCOVA|||The null hypothesis is the odds of worsening are the same in the placebo and the macitentan group. Logistic regression is used for Treatment Group vs. Placebo comparison to generate odds ratio, confidence levels, and p-values with treatment and WHO functional class at baseline as factors in the model.||1.464|0.001|0.0962
72483794|NCT02021292|144494456|SUPERIORITY||Model-adjusted geometric mean ratio|0.81||||0.0098|TWO_SIDED|95.0|0.7|0.95||This is the post-hoc analysis and p-value is an exploratory p-value.|ANCOVA|ANCOVA model on log-transformed % of baseline PVR at Week 16 adjusted by treatment as a factor and log transformed PVR at baseline as a covariate.||The same statistical model as for the predefined analysis (ANCOVA) was applied, including 13 subjects with corrected hemodynamic values.||0.95|0.70|0.0098
72483795|NCT02021292|144494457|SUPERIORITY||Model-adjusted geometric mean ratio|0.79||||0.0061|TWO_SIDED|95.0|0.68|0.93||This is the post-hoc analysis and p-value is an exploratory p-value.|ANCOVA|ANCOVA model on log-transformed % of baseline PVR at Week 16 adjusted by treatment as a factor and log transformed PVR at baseline as a covariate.||||0.93|0.68|0.0061
72402371|NCT01480076|144311676|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 3, RRMS. Mixed effect model for repeated measures with visit, baseline PCS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
72402372|NCT01480076|144311676|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 3, SPMS. Mixed effect model for repeated measures with visit, baseline PCS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
72483796|NCT02021292|144494458|SUPERIORITY||Geometric mean ratio|0.85||||0.0414|TWO_SIDED|95.0|0.73|0.99||This is the post-hoc analysis and p-value is an exploratory p-value.|ANCOVA|ANCOVA model on log-transformed % of baseline PVR at Week 16 adjusted by treatment as a factor and log transformed PVR at baseline as a covariate.||||0.99|0.73|0.0414
72483797|NCT02021292|144494459|SUPERIORITY||least squares (LS) mean difference|37.19||||0.0468|TWO_SIDED|95.0|0.54|73.83||This is the post-hoc analysis and p-value is an exploratory p-value.|ANCOVA|Statistical model is ANCOVA including 6MWD at baseline as a covariate, with treatment as factor in the model.||||73.83|0.54|0.0468
72483798|NCT03865940|144494473|SUPERIORITY|||||||0.374|TWO_SIDED|95.0||||P-values less than 0.05 considered significant.|Regression, Cox|Testing null hypothesis that guanfacine has no effect on time from injection to return to baseline.||||||0.374
72483799|NCT03865940|144494474|SUPERIORITY||||||<|0.001||||||P-values less than 0.05 considered significant.|Regression, Logistic|Analysis adjusted for pre-injection score and accounted for repeated measures. Effect of study drug was tested using a four degree-of-freedom test.||||||<0.001
72483800|NCT03865940|144494475|SUPERIORITY|||||||0.775|||||||Regression, Linear|The analysis adjusted for pre-injection score and accounted for repeat measures.The results of the analyses tested using a two degree-of-freedom test.||||||0.775
72483801|NCT03865940|144494476|SUPERIORITY|||||||0.099|||||||Regression, Linear|The analysis adjusted for pre-injection score and accounted for repeat measures.The results of the analyses tested using a two degree-of-freedom test.||||||0.099
72483802|NCT03865940|144494477|SUPERIORITY|||||||0.907|||||||Proportional Odds Regression|The analysis was not adjusted for baseline factors.||||||0.907
72483803|NCT03865940|144494478|SUPERIORITY|||||||0.373|||||||Regression, Logistic|Adjusted for use of pain medication at baseline||||||0.373
72483804|NCT02366728|144494519|OTHER|||||||0.072|||||||Log Rank|||||||0.072
72483805|NCT02366728|144494519|OTHER|||||||0.089|||||||Log Rank|||||||0.089
72483806|NCT02366728|144494520|OTHER|||||||0.0195|||||||Wilcoxon (Mann-Whitney)|||||||0.0195
72483807|NCT02366728|144494521|OTHER|||||||0.4|||||||Log Rank|||||||0.40
72483808|NCT02366728|144494522|OTHER|||||||0.4|||||||Log Rank|||||||0.40
72402373|NCT01480076|144311676|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 3, PPMS. Mixed effect model for repeated measures with visit, baseline PCS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
72483809|NCT02366728|144494523|OTHER|||||||0.16|||||||Log Rank|||||||0.16
72483810|NCT02366728|144494523|OTHER|||||||0.078|||||||Log Rank|||||||0.078
72483811|NCT02366728|144494524|OTHER|||||||0.64|||||||Log Rank|||||||0.64
72483812|NCT02366728|144494525|OTHER|||||||0.29|||||||Log Rank|||||||0.29
72483813|NCT00992511|144494528|NON_INFERIORITY|Criterion for non-inferiority: upper limit (UL) of the two-sided 95% Confidence Interval (CI) for the ratio of GMT between the initial process-manufactured vaccine (GSK2340272A INI 2D Group) and (over) new process-manufactured vaccine (GSK2340272A NEW 2D Group) was less than or equal to (≤) 2.|Adjusted GMT ratio|1.06|||||TWO_SIDED|95.0|0.77|1.46||||||To evaluate the immunological non-inferiority (in terms of vaccine-homologous virus H1N1 Haemagglutinin Inhibition \[HI\] antibody geometric mean titres \[GMTs\]) of the new process-manufactured A/California/7/2009 (H1N1)v-like antigen compared to the initial process-manufactured A/California/7/2009 (H1N1)v-like antigen, 21 days after first vaccination in healthy subjects aged 18 to 60 years.||1.46|0.77|
72567297|NCT00518882|144665553|SUPERIORITY_OR_OTHER||Estimated treatment difference, LS Mean|-1.01|||<|0.0001||95.0|-1.37|-0.65||There were no multiplicity concerns.|ANCOVA|||ANCOVA model included treatment, country and previous treatment as fixed effects and baseline fasting plasma glucose as covariate. The objective was to demonstrate that treatment with liraglutide was different from treatment with exenatide. Thus the null hypothesis and its alternative were H0: µliraglutide = µexenatide against HA1:µliraglutide ≠ µexenatide where µliraglutide and µexenatide is the mean value of the fasting plasma glucose in the liraglutide and exenatide arm, respectively.||-0.65|-1.37|<0.0001
72483814|NCT00992511|144494528|NON_INFERIORITY|Criterion for non-inferiority: upper limit (UL) of the two-sided 95% Confidence Interval (CI) for the ratio of GMT between the initial process-manufactured vaccine (GSK2340272A INI 2D Group) and (over) new process-manufactured vaccine (GSK2340272A NEW 2D Group) was less than or equal to (≤) 2.|Adjusted GMT ratio|1.17|||||TWO_SIDED|95.0|0.86|1.61||||||To evaluate the immunological non-inferiority (in terms of vaccine-homologous virus H1N1 Haemagglutinin Inhibition \[HI\] antibody geometric mean titres \[GMTs\]) of the new process-manufactured A/California/7/2009 (H1N1)v-like antigen compared to the initial process-manufactured A/California/7/2009 (H1N1)v-like antigen, 21 days after first vaccination in healthy subjects aged 18 to 60 years.||1.61|0.86|
72483815|NCT04498169|144494546|SUPERIORITY|With a sample size of up-to 20 subjects within a treatment group, the study had 80% power to demonstrate a statistically significant mean change from baseline, assuming the true effect size (mean change / SD) was 0.577 or larger (e.g. assuming the true mean change from baseline was 34.6 μm and the SD was 60 μm), a one sample t-test and a two-sided alpha = 0.10.||||||0.0021|||||||One-sample t-test (within group)|||The primary analysis used the mITT population with available data per subject at eye level (ie., ODO). Robustness analyses was also performed based on the MI methodology under different assumptions of missingness and intercurrent events (where missing data or withdrawal due to lack of efficacy or AEs were imputed using FCS regression method and missing data for all other reasons were imputed using worst within subject observation prior to the intercurrent event).||||0.0021
72402374|NCT01480076|144311676|SUPERIORITY_OR_OTHER|||||||0.0069|||||||mixed effect model|||Month 3, PRMS. Mixed effect model for repeated measures with visit, baseline PCS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.0069
72402375|NCT01480076|144311676|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 6, RRMS. Mixed effect model for repeated measures with visit, baseline PCS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
72402376|NCT01480076|144311676|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 6, SPMS. Mixed effect model for repeated measures with visit, baseline PCS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
72402377|NCT01480076|144311676|SUPERIORITY_OR_OTHER|||||||0.0001|||||||mixed effect model|||Month 6, PPMS. Mixed effect model for repeated measures with visit, baseline PCS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.0001
72483816|NCT01621230|144494567|OTHER|The median (first and third quartile) lengths of the second stage of labor were estimated at 28min (15, 58) in women without epidural analgesia. Assuming a one-third increase in the length of the second stage to 37min due to epidural bupivacaine, a sample size of 155 per arm (310 total) was required for 80% power to detect such a difference using a two-sided Wilcoxon rank sum test.||||||0.17|||||||Wilcoxon (Mann-Whitney)|||||||0.17
72483817|NCT01621230|144494570|OTHER|||||||0.55|||||||Wilcoxon (Mann-Whitney)|||||||.55
72483818|NCT01621230|144494571|OTHER|||||||0.57|||||||Wilcoxon (Mann-Whitney)|||||||.57
72512024|NCT02065622|144554181|SUPERIORITY||Adjusted risk difference|2.3||||0.301|TWO_SIDED|95.0|-2.0|6.6|||Cochran-Mantel-Haenszel||Risk difference = (adalimumab higher induction dose - adalimumab standard induction dose).|Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel test adjusted for previous infliximab use and baseline corticosteroid use.||6.6|-2.0|0.301
72512025|NCT02065622|144554181|SUPERIORITY|||||||0.502|||||||Breslow-Day test|Breslow-Day test of homogeneity across strata.||||||0.502
72512026|NCT02065622|144554182|SUPERIORITY||Adjusted risk difference|9.9||||0.069|TWO_SIDED|95.0|-0.8|20.6|||Cochran-Mantel-Haenszel||Risk difference = Adalimumab 40mg EW - Adalimumab 40mg EOW.|Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel (CMH) test adjusted for induction treatment regimen and week 8 remission status.||20.6|-0.8|0.069
72512027|NCT02065622|144554182|SUPERIORITY|||||||0.085|||||||Breslow-Day test|Breslow-Day test of homogeneity across strata.||||||0.085
72512028|NCT02065622|144554182|SUPERIORITY||Adjusted risk difference|10.3||||0.045|TWO_SIDED|95.0|0.2|20.4|||Cochran-Mantel-Haenszel||Risk difference = Adalimumab 40mg EW - Adalimumab 40mg EOW.|Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel (CMH) test adjusted for induction treatment regimen and week 8 remission status.||20.4|0.2|0.045
72567298|NCT00518882|144665554|SUPERIORITY_OR_OTHER||Mean|0.7|STANDARD_DEVIATION|1.84|<|0.0001||95.0|0.48|1.0|||Paired t test|||The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 26 and 78 were constructed. H0 was µ78- µ26=0 against HA: µ78 - µ26 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.||1.00|0.48|<0.0001
72402378|NCT01480076|144311676|SUPERIORITY_OR_OTHER|||||||0.0006|||||||mixed effect model|||Month 6, PRMS. Mixed effect model for repeated measures with visit, baseline PCS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.0006
72402379|NCT01480076|144311676|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 9, RRMS. Mixed effect model for repeated measures with visit, baseline PCS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
72483819|NCT00448435|144494573|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence margin + or - 15 L/min|Mean Difference (Net)|2.8|STANDARD_ERROR_OF_MEAN|5.91||0.6383||95.0|-9.1|14.69||Confidence Interval|Mixed Models Analysis|||Difference between treatments \[(SLM + FP)- SFC\](SE) 2.8 (5.91)||14.69|-9.10|0.6383
72483820|NCT01387230|144494587|SUPERIORITY_OR_OTHER||Least squares mean difference|0.127|||<|0.001|TWO_SIDED|95.0|0.052|0.202|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM)|Least squares mean difference=UMEC 62.5 µg minus Placebo.|||0.202|0.052|<0.001
72483821|NCT01387230|144494587|SUPERIORITY_OR_OTHER||Least squares mean difference|0.152|||<|0.001|TWO_SIDED|95.0|0.076|0.229|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM)|Least squares mean difference=UMEC 125 µg minus Placebo.|||0.229|0.076|<0.001
72512029|NCT02065622|144554182|SUPERIORITY|||||||0.106|||||||Breslow-Day test|Breslow-Day test of homogeneity across strata.||||||0.106
72512030|NCT02065622|144554183|SUPERIORITY||Adjusted risk difference|4.2||||0.181|TWO_SIDED|95.0|-2.0|10.5|||Cochran-Mantel-Haenszel||Risk difference = (adalimumab higher induction dose - adalimumab standard induction dose).|Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel test adjusted for previous infliximab use and baseline corticosteroid use.||10.5|-2.0|0.181
72512031|NCT02065622|144554183|SUPERIORITY||Adjusted risk difference|3.8||||0.2|TWO_SIDED|95.0|-2.0|9.7|||Cochran-Mantel-Haenszel||Risk difference = (adalimumab higher induction dose - adalimumab standard induction dose).|Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel test adjusted for previous infliximab use and baseline corticosteroid use.||9.7|-2.0|0.200
72483822|NCT04561765|144494599|SUPERIORITY|||||||0.051|||||||ANOVA|Reported p-values are based on Tukey's HSD post-hoc adjustment to one-way ANOVA.||P values at discharge||||0.051
72483823|NCT04561765|144494599|SUPERIORITY|||||||0.206|||||||ANOVA|Reported p-values are based on Tukey's HSD post-hoc adjustment to one-way ANOVA.||P values at discharge.||||0.206
72483824|NCT04561765|144494599|SUPERIORITY|||||||0.765|||||||ANOVA|Reported p-values are based on Tukey's HSD post-hoc adjustment to one-way ANOVA.||P values at discharge||||0.765
72483825|NCT04561765|144494599|SUPERIORITY|||||||0.991|||||||ANOVA|Reported p-values are based on Tukey's HSD post-hoc adjustment to one-way ANOVA.||P values at follow-up.||||0.991
72483826|NCT04561765|144494599|SUPERIORITY|||||||0.963|||||||ANOVA|Reported p-values are based on Tukey's HSD post-hoc adjustment to one-way ANOVA.||P values at discharge.||||0.963
72483827|NCT04561765|144494599|SUPERIORITY|||||||0.916|||||||ANOVA|Reported p-values are based on Tukey's HSD post-hoc adjustment to one-way ANOVA.||P values at discharge.||||0.916
72483828|NCT04561765|144494600|SUPERIORITY|||||||0.005|||||||ANOVA|Reported p-values are based on Tukey's HSD post-hoc adjustment to one-way ANOVA.||P value at discharge.||||0.005
72512032|NCT02065622|144554184|SUPERIORITY||Adjusted risk difference|3.0||||0.3|TWO_SIDED|95.0|-2.6|8.6|||Cochran-Mantel-Haenszel||Risk difference = (adalimumab higher induction dose - adalimumab standard induction dose).|Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel test adjusted for previous infliximab use and baseline corticosteroid use.||8.6|-2.6|0.300
72402380|NCT01480076|144311676|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 9, SPMS. Mixed effect model for repeated measures with visit, baseline PCS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
72483829|NCT04561765|144494600|SUPERIORITY|||||||0.27|||||||ANOVA|Reported p-values are based on Tukey's HSD post-hoc adjustment to one-way ANOVA.||P value at discharge.||||0.270
72483830|NCT04561765|144494600|SUPERIORITY|||||||0.177|||||||ANOVA|Reported p-values are based on Tukey's HSD post-hoc adjustment to one-way ANOVA.||P value at discharge.||||0.177
72483831|NCT04561765|144494600|SUPERIORITY|||||||0.3|||||||ANOVA|Reported p-values are based on Tukey's HSD post-hoc adjustment to one-way ANOVA.||P Value at follow-up.||||0.300
72483832|NCT04561765|144494600|SUPERIORITY|||||||0.996|||||||ANOVA|Reported p-values are based on Tukey's HSD post-hoc adjustment to one-way ANOVA.||||||0.996
72483833|NCT04561765|144494600|SUPERIORITY|||||||0.334|||||||ANOVA|Reported p-values are based on Tukey's HSD post-hoc adjustment to one-way ANOVA.||||||0.334
72483834|NCT04561765|144494602|SUPERIORITY|||||||0.212|||||||ANOVA|Reported p-values are based on Tukey's HSD post-hoc adjustment to one-way ANOVA.||P value at discharge.||||0.212
72483835|NCT04561765|144494602|SUPERIORITY|||||||0.965|||||||ANOVA|Reported p-values are based on Tukey's HSD post-hoc adjustment to one-way ANOVA.||||||0.965
72483836|NCT04561765|144494602|SUPERIORITY|||||||0.294|||||||ANOVA|Reported p-values are based on Tukey's HSD post-hoc adjustment to one-way ANOVA.||P value at discharge.||||0.294
72483837|NCT04561765|144494602|SUPERIORITY|||||||0.207|||||||ANOVA|Reported p-values are based on Tukey's HSD post-hoc adjustment to one-way ANOVA.||P value at follow-up.||||0.207
72483838|NCT04561765|144494602|SUPERIORITY|||||||0.158|||||||ANOVA|Reported p-values are based on Tukey's HSD post-hoc adjustment to one-way ANOVA.||P value at follow-up.||||0.158
72483839|NCT04561765|144494602|SUPERIORITY|||||||0.988|||||||ANOVA|Reported p-values are based on Tukey's HSD post-hoc adjustment to one-way ANOVA.||P value at follow-up.||||0.988
72483840|NCT04561765|144494604|SUPERIORITY|||||||0.295|||||||ANOVA|Reported p-values are based on Tukey's HSD post-hoc adjustment to one-way ANOVA.||P value at discharge.||||0.295
72483841|NCT04561765|144494604|SUPERIORITY|||||||0.718|||||||ANOVA|Reported p-values are based on Tukey's HSD post-hoc adjustment to one-way ANOVA.||P value at discharge.||||0.718
72483842|NCT04561765|144494604|SUPERIORITY|||||||0.738|||||||ANOVA|Reported p-values are based on Tukey's HSD post-hoc adjustment to one-way ANOVA.||P value at discharge.||||0.738
72483843|NCT04561765|144494604|SUPERIORITY|||||||0.797|||||||ANOVA|Reported p-values are based on Tukey's HSD post-hoc adjustment to one-way ANOVA.||P value at follow-up.||||0.797
72483844|NCT04561765|144494604|SUPERIORITY|||||||0.26|||||||ANOVA|Reported p-values are based on Tukey's HSD post-hoc adjustment to one-way ANOVA.||P value at follow-up.||||0.260
72483845|NCT04561765|144494604|SUPERIORITY|||||||0.616|||||||ANOVA|Reported p-values are based on Tukey's HSD post-hoc adjustment to one-way ANOVA.||||||0.616
72483846|NCT04561765|144494605|SUPERIORITY|||||||0.333|||||||ANOVA|Reported p-values are based on Tukey's HSD post-hoc adjustment to one-way ANOVA.||P value at discharge.||||0.333
72483847|NCT04561765|144494605|SUPERIORITY|||||||0.003|||||||ANOVA|Reported p-values are based on Tukey's HSD post-hoc adjustment to one-way ANOVA.||P value at discharge.||||0.003
72483848|NCT04561765|144494605|SUPERIORITY|||||||0.106|||||||ANOVA|Reported p-values are based on Tukey's HSD post-hoc adjustment to one-way ANOVA.||P value at discharge.||||0.106
72483849|NCT04561765|144494605|SUPERIORITY|||||||0.541|||||||ANOVA|Reported p-values are based on Tukey's HSD post-hoc adjustment to one-way ANOVA.||P value at follow-up.||||0.541
72483850|NCT04561765|144494605|SUPERIORITY|||||||0.202|||||||ANOVA|Reported p-values are based on Tukey's HSD post-hoc adjustment to one-way ANOVA.||P value at follow-up.||||0.202
72512033|NCT02065622|144554184|SUPERIORITY||Adjusted risk difference|3.1||||0.254|TWO_SIDED|95.0|-2.2|8.4|||Cochran-Mantel-Haenszel||Risk difference = (adalimumab higher induction dose - adalimumab standard induction dose).|Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel test adjusted for previous infliximab use and baseline corticosteroid use.||8.4|-2.2|0.254
72512034|NCT02065622|144554185|SUPERIORITY||Adjusted risk difference|6.5||||0.05|TWO_SIDED|95.0|0.0|13.1|||Cochran-Mantel-Haenszel||Risk difference = (adalimumab higher induction dose - adalimumab standard induction dose).|Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel test adjusted for previous infliximab use and baseline corticosteroid use.||13.1|-0.0|0.050
72483851|NCT04561765|144494605|SUPERIORITY|||||||0.791|||||||ANOVA|Reported p-values are based on Tukey's HSD post-hoc adjustment to one-way ANOVA.||P value at follow-up.||||0.791
72483852|NCT04561765|144494606|SUPERIORITY|||||||0.026|||||||ANOVA|Reported p-values are based on Tukey's HSD post-hoc adjustment to one-way ANOVA.||P value at discharge.||||0.026
72483853|NCT04561765|144494606|SUPERIORITY|||||||0.15|||||||ANOVA|Reported p-values are based on Tukey's HSD post-hoc adjustment to one-way ANOVA.||P value at discharge.||||0.15
72483854|NCT04561765|144494606|SUPERIORITY|||||||0.745|||||||ANOVA|Reported p-values are based on Tukey's HSD post-hoc adjustment to one-way ANOVA.||||||0.745
72483855|NCT04561765|144494606|SUPERIORITY|||||||0.021|||||||ANOVA|Reported p-values are based on Tukey's HSD post-hoc adjustment to one-way ANOVA.||P value at follow-up.||||0.021
72483856|NCT04561765|144494606|SUPERIORITY|||||||0.155|||||||ANOVA|Reported p-values are based on Tukey's HSD post-hoc adjustment to one-way ANOVA.||P value at follow-up.||||0.155
72483857|NCT04561765|144494606|SUPERIORITY|||||||0.652|||||||ANOVA|Reported p-values are based on Tukey's HSD post-hoc adjustment to one-way ANOVA.||P value at follow-up.||||0.652
72483858|NCT04561765|144494607|SUPERIORITY|||||||0.343|||||||ANOVA|Reported p-values are based on Tukey's HSD post-hoc adjustment to one-way ANOVA.||P value at discharge.||||0.343
72483859|NCT04561765|144494607|SUPERIORITY|||||||0.995|||||||ANOVA|Reported p-values are based on Tukey's HSD post-hoc adjustment to one-way ANOVA.||P value at discharge.||||0.995
72483860|NCT04561765|144494607|SUPERIORITY|||||||0.371|||||||ANOVA|Reported p-values are based on Tukey's HSD post-hoc adjustment to one-way ANOVA.||P value at discharge.||||0.371
72483861|NCT04561765|144494607|SUPERIORITY|||||||0.228|||||||ANOVA|Reported p-values are based on Tukey's HSD post-hoc adjustment to one-way ANOVA.||P value at follow-up.||||0.228
72483862|NCT04561765|144494607|SUPERIORITY|||||||0.282|||||||ANOVA|Reported p-values are based on Tukey's HSD post-hoc adjustment to one-way ANOVA.||P value at follow-up.||||0.282
72483863|NCT04561765|144494607|SUPERIORITY|||||||0.986|||||||ANOVA|Reported p-values are based on Tukey's HSD post-hoc adjustment to one-way ANOVA.||||||0.986
72483864|NCT04561765|144494608|SUPERIORITY|||||||0.421|||||||ANOVA|Reported p-values are based on Tukey's HSD post-hoc adjustment to one-way ANOVA.||||||0.421
72567299|NCT00518882|144665554|SUPERIORITY_OR_OTHER||Mean|-0.1|STANDARD_DEVIATION|2.42||0.4864||95.0|-0.48|0.23|||Paired t test|||A paired t test was made within the group and 95% confidence intervals for the difference between Weeks 26 and 78 were constructed. H0 was µ78 - µ26 = 0 against HA: µ78 - µ26 ≠ 0. A difference between the two means (Week 26 and Week 78) was concluded when H0 was rejected at the 5% level.||0.23|-0.48|0.4864
72483865|NCT04561765|144494608|SUPERIORITY|||||||0.556|||||||ANOVA|Reported p-values are based on Tukey's HSD post-hoc adjustment to one-way ANOVA.||||||0.556
72483866|NCT03027557|144494609|SUPERIORITY||||||<|1e-05|||||||ANOVA|||||||< 0.00001
72483867|NCT03027557|144494610|SUPERIORITY||||||<|1e-05|||||||ANOVA|||||||< 0.00001
72483868|NCT03027557|144494611|SUPERIORITY||||||=|0.0019|||||||ANOVA|||||||= 0.0019
72483869|NCT03027557|144494612|SUPERIORITY||||||=|0.096|||||||ANOVA|||||||= 0.096
72483870|NCT03027557|144494613|SUPERIORITY||||||=|0.0001|||||||ANOVA|||||||= 0.0001
72483871|NCT03027557|144494614|SUPERIORITY||||||<|1e-05|||||||ANOVA|||||||< 0.00001
72483872|NCT03027557|144494615|SUPERIORITY||||||=|0.0027|||||||ANOVA|||||||= 0.0027
72483873|NCT03027557|144494616|SUPERIORITY||||||=|0.081|||||||ANOVA|||||||= 0.081
72483874|NCT03027557|144494617|SUPERIORITY||||||=|0.0071|||||||ANOVA|||||||= 0.0071
72483875|NCT03027557|144494618|SUPERIORITY||||||=|0.0001|||||||ANOVA|||||||= 0.0001
72483876|NCT03027557|144494619|SUPERIORITY||||||=|0.0001|||||||Kruskal-Wallis|||||||= 0.0001
72483877|NCT03027557|144494620|SUPERIORITY||||||=|0.38|||||||Kruskal-Wallis|||||||= 0.38
72483878|NCT03027557|144494625|SUPERIORITY||||||=|0.83|||||||Kruskal-Wallis|||||||= 0.83
72483879|NCT03027557|144494628|SUPERIORITY||||||>|0.05|||||||ANOVA|||||||>0.05
72483880|NCT03027557|144494629|SUPERIORITY||||||=|0.0077|||||||ANOVA|||||||= 0.0077
72483881|NCT03027557|144494630|SUPERIORITY||||||=|0.011|||||||ANOVA|||||||= 0.011
72483882|NCT03027557|144494631|SUPERIORITY||||||=|0.011|||||||ANOVA|||||||= 0.011
72483883|NCT03027557|144494632|SUPERIORITY||||||=|0.0001|||||||Kruskal-Wallis|||||||= 0.0001
72483884|NCT03027557|144494633|SUPERIORITY||||||<|1e-05|||||||ANOVA|||||||< 0.00001
72483885|NCT03027557|144494634|SUPERIORITY||||||=|0.0001|||||||Kruskal-Wallis|||||||= 0.0001
72483886|NCT03027557|144494635|SUPERIORITY||||||=|0.0001|||||||ANOVA|||||||= 0.0001
72483887|NCT03027557|144494636|SUPERIORITY||||||=|0.0001|||||||Kruskal-Wallis|||||||= 0.0001
72483888|NCT03027557|144494638|SUPERIORITY||||||=|0.5|||||||Kruskal-Wallis|||||||= 0.5
72483889|NCT03027557|144494639|SUPERIORITY||||||=|0.85|||||||ANOVA|||||||= 0.85
72483890|NCT03027557|144494640|SUPERIORITY||||||=|0.22|||||||ANOVA|||||||= 0.22
72483891|NCT03027557|144494641|SUPERIORITY||||||=|0.18|||||||Kruskal-Wallis|||||||= 0.18
72483892|NCT03836807|144494652|SUPERIORITY|||||||0.02|||||||ANOVA|||||||0.020
72483893|NCT03836807|144494653|SUPERIORITY|||||||0.026|||||||ANOVA|||||||0.026
72483894|NCT03836807|144494654|SUPERIORITY||adjusted least square mean|-0.3||||0.914|TWO_SIDED|95.0|-5.5|5.0|||ANOVA|The ANOVA model included fixed effect terms for clinical site, time point and treatment. Time point was specified as a repeated measurement.||at Baseline (at 0')||5.0|-5.5|0.914
72483895|NCT03836807|144494654|SUPERIORITY||adjusted least square mean|1.3||||0.685|TWO_SIDED|95.0|-4.9|7.4|||ANOVA|The ANOVA model included fixed effect terms for clinical site, time point and treatment. Time point was specified as a repeated measurement.||at 5'||7.4|-4.9|0.685
72483896|NCT03836807|144494654|SUPERIORITY||adjusted least square mean|-0.3||||0.93|TWO_SIDED|95.0|-7.4|6.8|||ANOVA|The ANOVA model included fixed effect terms for clinical site, time point and treatment. Time point was specified as a repeated measurement.||at 10'||6.8|-7.4|0.930
72483897|NCT03836807|144494654|SUPERIORITY||adjusted least square mean|-2.1||||0.615|TWO_SIDED|95.0|-10.3|6.1|||ANOVA|The ANOVA model included fixed effect terms for clinical site, time point and treatment. Time point was specified as a repeated measurement.||at 15'||6.1|-10.3|0.615
72483898|NCT03836807|144494654|SUPERIORITY||adjusted least square mean|-8.5||||0.051|TWO_SIDED|95.0|-17.0|0.0|||ANOVA|The ANOVA model included fixed effect terms for clinical site, time point and treatment. Time point was specified as a repeated measurement.||at 30'||0|-17.0|0.051
72483899|NCT03836807|144494654|SUPERIORITY||adjusted least square mean|-8.4||||0.043|TWO_SIDED|95.0|-16.6|-0.3|||ANOVA|The ANOVA model included fixed effect terms for clinical site, time point and treatment. Time point was specified as a repeated measurement.||at 45'||-0.3|-16.6|0.043
72483900|NCT03836807|144494654|SUPERIORITY||adjusted least square mean|-9.0||||0.023|TWO_SIDED|95.0|-16.7|-1.3|||ANOVA|The ANOVA model included fixed effect terms for clinical site, time point and treatment. Time point was specified as a repeated measurement.||at 1h||-1.3|-16.7|0.023
72512035|NCT02065622|144554185|SUPERIORITY||Adjusted risk difference|4.8||||0.131|TWO_SIDED|95.0|-1.4|11.0|||Cochran-Mantel-Haenszel||Risk difference = (adalimumab higher induction dose - adalimumab standard induction dose).|Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel test adjusted for previous infliximab use and baseline corticosteroid use.||11.0|-1.4|0.131
72512036|NCT02065622|144554186|SUPERIORITY||Adjusted risk difference|7.3||||0.035|TWO_SIDED|95.0|0.5|14.1|||Cochran-Mantel-Haenszel||Risk difference = (adalimumab higher induction dose - adalimumab standard induction dose).|Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel test adjusted for previous infliximab use and baseline corticosteroid use.||14.1|0.5|0.035
72512037|NCT02065622|144554186|SUPERIORITY||Adjusted risk difference|8.7||||0.008|TWO_SIDED|95.0|2.3|15.1|||Cochran-Mantel-Haenszel||Risk difference = (adalimumab higher induction dose - adalimumab standard induction dose).|Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel test adjusted for previous infliximab use and baseline corticosteroid use.||15.1|2.3|0.008
72483901|NCT03836807|144494654|SUPERIORITY||adjusted least square mean|-10.5||||0.009|TWO_SIDED|95.0|-18.2|-2.7|||ANOVA|The ANOVA model included fixed effect terms for clinical site, time point and treatment. Time point was specified as a repeated measurement.||at 1.5h||-2.7|-18.2|0.009
72483902|NCT03836807|144494654|SUPERIORITY||adjusted least square mean|-9.3||||0.018|TWO_SIDED|95.0|-17.0|-1.7|||ANOVA|The ANOVA model included fixed effect terms for clinical site, time point and treatment. Time point was specified as a repeated measurement.||at 2h||-1.7|-17.0|0.018
72483903|NCT03836807|144494654|SUPERIORITY||adjusted least square mean|-5.5||||0.182|TWO_SIDED|95.0|-13.6|2.6|||ANOVA|The ANOVA model included fixed effect terms for clinical site, time point and treatment. Time point was specified as a repeated measurement.||at 3h||2.6|-13.6|0.182
72512038|NCT02065622|144554187|SUPERIORITY||Adjusted risk difference|3.2||||0.16|TWO_SIDED|95.0|-1.3|7.6|||Cochran-Mantel-Haenszel||Risk difference = (adalimumab higher induction dose - adalimumab standard induction dose).|Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel test adjusted for previous infliximab use and baseline corticosteroid use.||7.6|-1.3|0.160
72512039|NCT02065622|144554187|SUPERIORITY||Adjusted risk difference|2.9||||0.166|TWO_SIDED|95.0|-1.2|7.1|||Cochran-Mantel-Haenszel||Risk difference = (adalimumab higher induction dose - adalimumab standard induction dose).|Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel test adjusted for previous infliximab use and baseline corticosteroid use.||7.1|-1.2|0.166
72512040|NCT02065622|144554188|SUPERIORITY||Adjusted risk difference|8.3||||0.011|TWO_SIDED|95.0|1.9|14.7|||Cochran-Mantel-Haenszel||Risk difference = (adalimumab higher induction dose - adalimumab standard induction dose).|Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel test adjusted for previous infliximab use and baseline corticosteroid use.||14.7|1.9|0.011
72512041|NCT02065622|144554188|SUPERIORITY||Adjusted risk difference|7.0||||0.025|TWO_SIDED|95.0|0.9|13.0|||Cochran-Mantel-Haenszel||Risk difference = (adalimumab higher induction dose - adalimumab standard induction dose).|Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel test adjusted for previous infliximab use and baseline corticosteroid use.||13.0|0.9|0.025
72567300|NCT00518882|144665555|SUPERIORITY_OR_OTHER||Mean|-1.3|STANDARD_DEVIATION|2.5|<|0.0001||95.0|-1.62|-0.92|||Paired t test|||The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 0 and 78 were constructed. H0 was µ78 - µ0=0 against HA: µ78 - µ0 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.||-0.92|-1.62|<0.0001
72624072|NCT03537508|144778466|NON_INFERIORITY|The overall non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI was \>-10% for all 4 serogroups. 95% CI of the difference was calculated from the Wilson Score method without continuity correction.|Difference in Percentage of Participants|7.83|||||TWO_SIDED|95.0|5.31|10.96||||||Statistical analysis for Serogroup C||10.96|5.31|
72483904|NCT03836807|144494654|SUPERIORITY||adjusted least square mean|-4.8||||0.236|TWO_SIDED|95.0|-12.9|3.2|||ANOVA|The ANOVA model included fixed effect terms for clinical site, time point and treatment. Time point was specified as a repeated measurement.||at 4h||3.2|-12.9|0.236
72483905|NCT03836807|144494654|SUPERIORITY||adjusted least square mean|-3.6||||0.32|TWO_SIDED|95.0|-10.6|3.5|||ANOVA|The ANOVA model included fixed effect terms for clinical site, time point and treatment. Time point was specified as a repeated measurement.||at 5h||3.5|-10.6|0.320
72512042|NCT02065622|144554189|SUPERIORITY||Adjusted risk difference|4.2||||0.218|TWO_SIDED|95.0|-2.5|10.9|||Cochran-Mantel-Haenszel||Risk difference = (adalimumab higher induction dose - adalimumab standard induction dose).|Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel test adjusted for previous infliximab use and baseline corticosteroid use.||10.9|-2.5|0.218
72567301|NCT00518882|144665555|SUPERIORITY_OR_OTHER||Mean|-0.8|STANDARD_DEVIATION|2.76|<|0.0001||95.0|-1.23|-0.42|||Paired t test|||The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 0 and 78 were constructed. H0 was µ78 - µ0=0 against HA: µ78 - µ0 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.||-0.42|-1.23|<0.0001
72483906|NCT03836807|144494654|SUPERIORITY||adjusted least square mean|-2.2||||0.572|TWO_SIDED|95.0|-10.0|5.6|||ANOVA|The ANOVA model included fixed effect terms for clinical site, time point and treatment. Time point was specified as a repeated measurement.||at 6h||5.6|-10.0|0.572
72483907|NCT03836807|144494655|SUPERIORITY||adjusted least square mean|2.7||||0.361|TWO_SIDED|95.0|-3.1|8.4|||ANOVA|The ANOVA model included fixed effect terms for clinical site, time point and treatment. Time point was specified as a repeated measurement.||at 5'||8.4|-3.1|0.361
72483908|NCT03836807|144494655|SUPERIORITY||adjusted least square mean|4.2||||0.298|TWO_SIDED|95.0|-3.8|12.3|||ANOVA|The ANOVA model included fixed effect terms for clinical site, time point and treatment. Time point was specified as a repeated measurement.||at 10'||12.3|-3.8|0.298
72483909|NCT03836807|144494655|SUPERIORITY||adjusted least square mean|8.9||||0.112|TWO_SIDED|95.0|-2.1|19.8|||ANOVA|The ANOVA model included fixed effect terms for clinical site, time point and treatment. Time point was specified as a repeated measurement.||at 15'||19.8|-2.1|0.112
72483910|NCT03836807|144494655|SUPERIORITY||adjusted least square mean|22.3||||0.003|TWO_SIDED|95.0|7.8|36.8|||ANOVA|The ANOVA model included fixed effect terms for clinical site, time point and treatment. Time point was specified as a repeated measurement.||at 30'||36.8|7.8|0.003
72483911|NCT03836807|144494655|SUPERIORITY||adjusted least square mean|21.2||||0.008|TWO_SIDED|95.0|5.6|36.7|||ANOVA|The ANOVA model included fixed effect terms for clinical site, time point and treatment. Time point was specified as a repeated measurement.||at 45'||36.7|5.6|0.008
72483912|NCT03836807|144494655|SUPERIORITY||adjusted least square mean|18.7||||0.018|TWO_SIDED|95.0|3.3|34.0|||ANOVA|The ANOVA model included fixed effect terms for clinical site, time point and treatment. Time point was specified as a repeated measurement.||at 1h||34.0|3.3|0.018
72483913|NCT03836807|144494655|SUPERIORITY||adjusted least square mean|22.3||||0.003|TWO_SIDED|95.0|7.7|37.0|||ANOVA|The ANOVA model included fixed effect terms for clinical site, time point and treatment. Time point was specified as a repeated measurement.||at 1.5h||37.0|7.7|0.003
72483914|NCT03836807|144494655|SUPERIORITY||adjusted least square mean|22.0||||0.003|TWO_SIDED|95.0|8.0|36.1|||ANOVA|The ANOVA model included fixed effect terms for clinical site, time point and treatment. Time point was specified as a repeated measurement.||at 2h||36.1|8.0|0.003
72483915|NCT03836807|144494655|SUPERIORITY||adjusted least square mean|16.7||||0.015|TWO_SIDED|95.0|3.4|30.0|||ANOVA|The ANOVA model included fixed effect terms for clinical site, time point and treatment. Time point was specified as a repeated measurement.||at 3h||30.0|3.4|0.015
72483916|NCT03836807|144494655|SUPERIORITY||adjusted least square mean|10.8||||0.103|TWO_SIDED|95.0|-2.2|23.9|||ANOVA|||at 4h||23.9|-2.2|0.103
72483917|NCT03836807|144494655|SUPERIORITY||adjusted least square mean|5.9||||0.311|TWO_SIDED|95.0|-5.6|17.5|||ANOVA|The ANOVA model included fixed effect terms for clinical site, time point and treatment. Time point was specified as a repeated measurement.||at 5'||17.5|-5.6|0.311
72512043|NCT02065622|144554189|SUPERIORITY||Adjusted risk difference|2.4||||0.456|TWO_SIDED|95.0|-4.0|8.8|||Cochran-Mantel-Haenszel||Risk difference = (adalimumab higher induction dose - adalimumab standard induction dose).|Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel test adjusted for previous infliximab use and baseline corticosteroid use.||8.8|-4.0|0.456
72512044|NCT02065622|144554190|SUPERIORITY||Adjusted risk difference|9.5||||0.098|TWO_SIDED|95.0|-1.7|20.8|||Cochran-Mantel-Haenszel||Risk difference = Adalimumab 40mg EW - Adalimumab 40mg EOW.|Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel (CMH) test adjusted for induction treatment regimen and week 8 remission status.||20.8|-1.7|0.098
72512045|NCT02065622|144554190|SUPERIORITY||Adjusted risk difference|9.9||||0.066|TWO_SIDED|95.0|-0.7|20.5|||Cochran-Mantel-Haenszel||Risk difference = Adalimumab 40mg EW - Adalimumab 40mg EOW.|Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel (CMH) test adjusted for induction treatment regimen and week 8 remission status.||20.5|-0.7|0.066
72483918|NCT03836807|144494655|SUPERIORITY||adjusted least square mean|2.8||||0.638|TWO_SIDED|95.0|-9.0|14.5|||ANOVA|The ANOVA model included fixed effect terms for clinical site, time point and treatment. Time point was specified as a repeated measurement.||at 6h||14.5|-9.0|0.638
72483919|NCT03836807|144494656|SUPERIORITY|||||||0.007|||||||ANOVA|||in the ITT population||||0.007
72483920|NCT03836807|144494656|SUPERIORITY|||||||0.009|||||||ANOVA|||in the PP population||||0.009
72483921|NCT03836807|144494657|SUPERIORITY|||||||0.004|||||||Log Rank|||||||0.004
72483922|NCT03836807|144494658|SUPERIORITY|||||||0.002|||||||Log Rank|||||||0.002
72483923|NCT03836807|144494659|SUPERIORITY|||||||0.48|||||||Wilcoxon (Mann-Whitney)|||||||0.480
72483924|NCT02430051|144494660|SUPERIORITY|||||||0.01|||||||Mixed-effects regression model|Adjusted for attained age and first or second clinic visit.||||||0.01
72483925|NCT02430051|144494661|SUPERIORITY|||||||0.25|||||||Mixed-effects regression model|Adjustment for attained age and first and second clinic visit.||||||0.25
72483926|NCT02430051|144494662|SUPERIORITY|||||||0.87|||||||Wilcoxon (Mann-Whitney)|||||||0.87
72483927|NCT02430051|144494663|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
72483928|NCT02430051|144494664|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
72483929|NCT02430051|144494665|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
72483930|NCT02430051|144494666|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
72483931|NCT02430051|144494667|SUPERIORITY|||||||0.92|||||||Wilcoxon (Mann-Whitney)|||||||0.92
72483932|NCT02430051|144494668|SUPERIORITY|||||||0.16|||||||Wilcoxon (Mann-Whitney)|||||||0.16
72483933|NCT02430051|144494669|SUPERIORITY|||||||0.76|||||||Wilcoxon (Mann-Whitney)|||||||0.76
72483934|NCT02430051|144494670|SUPERIORITY|||||||0.8|||||||Wilcoxon (Mann-Whitney)|||||||0.80
72483935|NCT02430051|144494671|SUPERIORITY||||||<|0.0001|||||||Multivariate linear regression|Adjusted for autism severity, IQ, dental fear and anxiety, sensory over-responsivity, general anxiety, expressive communication, gender, and age.||||||<0.0001
72483936|NCT02430051|144494672|SUPERIORITY|||||||0.61|||||||General linear mixed model|||||||0.61
72483937|NCT04722250|144494673|NON_INFERIORITY|The endpoint is designed to test whether the Medtronic SE TAV is non-inferior to Edwards BE TAV in the composite event rate of all-cause mortality, disabling stroke or heart failure rehospitalization at 12 months post-procedure with an absolute non-inferiority margin of 8.0%.|Risk Difference (RD)|-1.2|||<|0.001|TWO_SIDED|90.0|-4.9|2.5|||z-test on Kaplan-Meier percentages|||||2.5|-4.9|<0.001
72483938|NCT04722250|144494674|SUPERIORITY||Risk Difference (RD)|-32.2|||<|0.001|TWO_SIDED|95.0|-38.7|-25.6|||z-test on Kaplan-Meier percentages|||||-25.6|-38.7|<0.001
72483939|NCT04124614|144494744|SUPERIORITY|MMRM method with model terms: treatment, (pooled) study center, previous pharmacological treatment intervention for PTSD (yes/no), visit, treatment by visit and baseline by visit interaction.|Treatment Difference|-5.59||||0.0007|TWO_SIDED|95.0|-8.79|-2.38|||MMRM|||||-2.38|-8.79|0.0007
72483940|NCT04124614|144494745|SUPERIORITY|MMRM method with model terms: treatment, (pooled) study center, previous pharmacological treatment intervention for PTSD (yes/no), visit, treatment by visit and baseline by visit interaction.|Treatment Difference|-0.47||||0.0019|TWO_SIDED|95.0|-0.76|-0.17|||MMRM|||||-0.17|-0.76|0.0019
72483941|NCT04124614|144494746|SUPERIORITY|MMRM method with model terms: treatment, (pooled) study center, previous pharmacological treatment intervention for PTSD (yes/no), visit, treatment by visit and baseline by visit interaction.|Treatment Difference|-12.03||||0.0016|TWO_SIDED|95.0|-19.44|-4.62|||MMRM|||||-4.62|-19.44|0.0016
72483942|NCT02022085|144494750|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||PTA4 6 months with Baha Attract vs Unaided||||<0.0001
72483943|NCT02022085|144494750|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Fisher's non-parametric permutation test|||PTA4 12 months with Baha Attract vs Unaided||||<0.0001
72483944|NCT02022085|144494750|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Fisher's non-parametric permutation test|||PTA4 24 months with Baha Attract vs Unaided||||<0.0001
72483945|NCT02022085|144494751|SUPERIORITY_OR_OTHER||||||<|0.0001||||||All comparisons to the Unaided situation were p=\<0.0001.|Fisher's non-parametric permutation test|||Baha Attract after 24 months vs Unaided situation Pre-Op||||<0.0001
72512046|NCT02065622|144554191|SUPERIORITY||Adjusted risk difference|21.5||||0.002|TWO_SIDED|95.0|7.6|35.4|||Cochran-Mantel-Haenszel|Risk difference = Adalimumab 40mg EW - Adalimumab 40mg EOW.||Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel (CMH) test adjusted for induction treatment regimen and week 8 remission status.||35.4|7.6|0.002
72483946|NCT02022085|144494752|SUPERIORITY_OR_OTHER||||||<|0.0001||||||All comparisons to the Unaided situation were p=\<0.0001.|Fisher's non-parametric permutation test|||Baha Attract after 12 months vs Unaided situation Pre-Op||||<0.0001
72483947|NCT02022085|144494753|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|95.0||||All comparisons to the Unaided situation were p=\<0.0001.|Fisher's non-parametric permutation test|||Baha Attract after 6 months vs Unaided situation Pre-Op||||<0.0001
72483948|NCT02022085|144494754|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Speech in Noise, 6 months Baha Attract vs Unaided||||<0.0001
72483949|NCT02022085|144494754|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Fisher's non-parametric permutation test|||Speech in Noise, 12 months Baha Attract vs Unaided||||<0.0001
72483950|NCT02022085|144494754|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Fisher's non-parametric permutation test|||Speech in Noise, 24 months Baha Attract vs Unaided||||<0.0001
72512047|NCT02065622|144554191|SUPERIORITY||Adjusted risk difference|19.7||||0.003|TWO_SIDED|95.0|6.6|32.7|||Cochran-Mantel-Haenszel||Risk difference = Adalimumab 40mg EW - Adalimumab 40mg EOW.|Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel (CMH) test adjusted for induction treatment regimen and week 8 remission status.||32.7|6.6|0.003
72512048|NCT02065622|144554192|SUPERIORITY||Adjusted risk difference|11.5||||0.093|TWO_SIDED|95.0|-1.9|25.0|||Cochran-Mantel-Haenszel||Risk difference = Adalimumab 40mg EW - Adalimumab 40mg EOW.|Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel (CMH) test adjusted for induction treatment regimen and week 8 remission status.||25.0|-1.9|0.093
72483951|NCT02022085|144494755|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||6 months: Speech in quiet at 50dB||||<0.0001
72483952|NCT02022085|144494755|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Fisher's non-parametric permutation test|||6 months: Speech in quiet at 65dB||||<0.0001
72483953|NCT02022085|144494755|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Fisher's non-parametric permutation test|||6 months: Speech in quiet at 80dB||||<0.0001
72483954|NCT02022085|144494755|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Fisher's non-parametric permutation test|||12 months: Speech in quiet at 50dB||||<0.0001
72483955|NCT02022085|144494755|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Fisher's non-parametric permutation test|||12 months: Speech in quiet at 65dB||||<0.0001
72483956|NCT02022085|144494755|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Fisher's non-parametric permutation test|||12 months: Speech in quiet at 80dB||||<0.0001
72483957|NCT02022085|144494755|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Fisher's non-parametric permutation test|||24 months: Speech in quiet at 50dB||||<0.0001
72483958|NCT02022085|144494755|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Fisher's non-parametric permutation test|||24 months: Speech in quiet at 65dB||||<0.0001
72483959|NCT02022085|144494755|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Fisher's non-parametric permutation test|||24 months: Speech in quiet at 80dB||||<0.0001
72483960|NCT02022085|144494756|SUPERIORITY_OR_OTHER|||||||0.38|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||6 months with Baha Attract vs Softband: change in PTA4||||0.38
72483961|NCT02022085|144494756|SUPERIORITY_OR_OTHER|||||||0.84|||||||Fisher's non-parametric permutation test|||12 months with Baha Attract vs Softband: change in PTA4||||0.84
72483962|NCT02022085|144494756|SUPERIORITY_OR_OTHER|||||||0.89|||||||Fisher's non-parametric permutation test|||24 months with Baha Attract vs Softband: change in PTA4||||0.89
72483963|NCT02022085|144494757|SUPERIORITY_OR_OTHER|||||||0.34|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||250Hz: 6 months with Baha Attract vs Softband||||0.34
72483964|NCT02022085|144494757|SUPERIORITY_OR_OTHER|||||||0.0004|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||500Hz: 6 months with Baha Attract vs Softband||||0.0004
72483965|NCT02022085|144494757|SUPERIORITY_OR_OTHER|||||||0.22|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||1000Hz: 6 months with Baha Attract vs Softband||||0.22
72402381|NCT01480076|144311676|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 9, PPMS. Mixed effect model for repeated measures with visit, baseline PCS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
72483966|NCT02022085|144494757|SUPERIORITY_OR_OTHER|||||||0.64|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||2000Hz: 6 months with Baha Attract vs Softband||||0.64
72483967|NCT02022085|144494757|SUPERIORITY_OR_OTHER|||||||0.039|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||3000Hz: 6 months with Baha Attract vs Softband||||0.039
72483968|NCT02022085|144494757|SUPERIORITY_OR_OTHER|||||||0.012|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||4000Hz: 6 months with Baha Attract vs Softband||||0.012
72483969|NCT02022085|144494757|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||6000Hz: 6 months with Baha Attract vs Softband||||<0.0001
72483970|NCT02022085|144494758|SUPERIORITY_OR_OTHER|||||||0.11|||||||Fisher's non-parametric permutation test|||250Hz: 12 months with Baha Attract vs Softband||||0.11
72483971|NCT02022085|144494758|SUPERIORITY_OR_OTHER|||||||0.066|||||||Fisher's non-parametric permutation test|||500Hz: 12 months with Baha Attract vs Softband||||0.066
72483972|NCT02022085|144494758|SUPERIORITY_OR_OTHER|||||||0.71|||||||Fisher's non-parametric permutation test|||1000Hz: 12 months with Baha Attract vs Softband||||0.71
72483973|NCT02022085|144494758|SUPERIORITY_OR_OTHER|||||||0.78|||||||Fisher's non-parametric permutation test|||2000Hz: 12 months with Baha Attract vs Softband||||0.78
72483974|NCT02022085|144494758|SUPERIORITY_OR_OTHER|||||||0.015|||||||Fisher's non-parametric permutation test|||3000Hz: 12 months with Baha Attract vs Softband||||0.015
72483975|NCT02022085|144494758|SUPERIORITY_OR_OTHER|||||||0.035|||||||Fisher's non-parametric permutation test|||4000Hz: 12 months with Baha Attract vs Softband||||0.035
72512049|NCT02065622|144554192|SUPERIORITY||Adjusted risk difference|11.1||||0.088|TWO_SIDED|95.0|-1.7|23.8|||Cochran-Mantel-Haenszel||Risk difference = Adalimumab 40mg EW - Adalimumab 40mg EOW.|Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel (CMH) test adjusted for induction treatment regimen and week 8 remission status.||23.8|-1.7|0.088
72567302|NCT00518882|144665556|SUPERIORITY_OR_OTHER||Estimated treatment difference, LS Mean|1.33|||<|0.0001||95.0|0.8|1.86||There were no multiplicity concerns.|ANCOVA|||ANCOVA model included treatment, country and previous treatment as fixed effects and baseline value of the endpoint as covariate. The objective was to demonstrate that treatment with liraglutide was different from treatment with exenatide. Thus the null hypothesis and its alternative were H0: µliraglutide = µexenatide against HA1:µliraglutide ≠ µexenatide where µliraglutide and µexenatide is the mean value of the endpoint in the liraglutide arm and exenatide arm, respectively.||1.86|0.80|<.0001
72567303|NCT00518882|144665557|SUPERIORITY_OR_OTHER||Estimated treatment difference, LS Mean|0.01||||0.9849||95.0|-0.52|0.53||There were no multiplicity concerns.|ANCOVA|||ANCOVA model included treatment, country and previous treatment as fixed effects and baseline value of the endpoint as covariate. The objective was to demonstrate that treatment with liraglutide was different from treatment with exenatide. Thus the null hypothesis and its alternative were H0: µliraglutide = µexenatide against HA1:µliraglutide ≠ µexenatide where µliraglutide and µexenatide is the mean value of the endpoint in the liraglutide arm and exenatide arm, respectively.||0.53|-0.52|0.9849
72624073|NCT03537508|144778466|NON_INFERIORITY|The overall non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI was \>-10% for all 4 serogroups. 95% CI of the difference was calculated from the Wilson Score method without continuity correction.|Difference in Percentage of Participants|6.53|||||TWO_SIDED|95.0|4.01|9.62||||||Statistical analysis for Serogroup Y||9.62|4.01|
72483976|NCT02022085|144494758|SUPERIORITY_OR_OTHER|||||||0.0013|||||||Fisher's non-parametric permutation test|||6000Hz: 12 months with Baha Attract vs Softband||||0.0013
72483977|NCT02022085|144494759|SUPERIORITY_OR_OTHER|||||||0.0051|||||||Fisher's non-parametric permutation test|||250Hz: 24 months with Baha Attract vs Softband||||0.0051
72483978|NCT02022085|144494759|SUPERIORITY_OR_OTHER|||||||0.26|||||||Fisher's non-parametric permutation test|||500Hz: 24 months with Baha Attract vs Softband||||0.26
72483979|NCT02022085|144494759|SUPERIORITY_OR_OTHER|||||||0.22|||||||Fisher's non-parametric permutation test|||1000Hz: 24 months with Baha Attract vs Softband||||0.22
72483980|NCT02022085|144494759|SUPERIORITY_OR_OTHER|||||||0.57|||||||Fisher's non-parametric permutation test|||2000Hz: 24 months with Baha Attract vs Softband||||0.57
72483981|NCT02022085|144494759|SUPERIORITY_OR_OTHER|||||||0.064|||||||Fisher's non-parametric permutation test|||3000Hz: 24 months with Baha Attract vs Softband||||0.064
72483982|NCT02022085|144494759|SUPERIORITY_OR_OTHER|||||||0.064|||||||Fisher's non-parametric permutation test|||4000Hz: 24 months with Baha Attract vs Softband||||0.064
72483983|NCT02022085|144494759|SUPERIORITY_OR_OTHER|||||||0.0051|||||||Fisher's non-parametric permutation test|||6000Hz: 24 months with Baha Attract vs Softband||||0.0051
72483984|NCT02022085|144494760|SUPERIORITY_OR_OTHER|||||||0.46|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||6 months: Speech in Noise with Baha Attract vs Softband||||0.46
72483985|NCT02022085|144494760|SUPERIORITY_OR_OTHER|||||||0.19|||||||Fisher's non-parametric permutation test|||12 months: Speech in Noise with Baha Attract vs Softband||||0.19
72483986|NCT02022085|144494760|SUPERIORITY_OR_OTHER|||||||0.31|||||||Fisher's non-parametric permutation test|||24 months: Speech in Noise with Baha Attract vs Softband||||0.31
72483987|NCT02022085|144494761|SUPERIORITY_OR_OTHER|||||||0.43|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||6 months Speech in Quiet at 50dB||||0.43
72483988|NCT02022085|144494761|SUPERIORITY_OR_OTHER|||||||0.16|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||6 months Speech in Quiet at 65dB||||0.16
72483989|NCT02022085|144494761|SUPERIORITY_OR_OTHER|||||||0.65|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||6 months Speech in Quiet at 80dB||||0.65
72483990|NCT02022085|144494761|SUPERIORITY_OR_OTHER|||||||0.93|||||||Fisher's non-parametric permutation test|||12 months Speech in Quiet at 50dB||||0.93
72483991|NCT02022085|144494761|SUPERIORITY_OR_OTHER|||||||0.094|||||||Fisher's non-parametric permutation test|||12 months Speech in Quiet at 65dB||||0.094
72483992|NCT02022085|144494761|SUPERIORITY_OR_OTHER|||||||0.44|||||||Fisher's non-parametric permutation test|||12 months Speech in Quiet at 80dB||||0.44
72483993|NCT02022085|144494761|SUPERIORITY_OR_OTHER|||||||0.021|||||||Fisher's non-parametric permutation test|||24 months Speech in Quiet at 50dB||||0.021
72402382|NCT01480076|144311676|SUPERIORITY_OR_OTHER|||||||0.004|||||||mixed effect model|||Month 9, PRMS. Mixed effect model for repeated measures with visit, baseline PCS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.0040
72483994|NCT02022085|144494761|SUPERIORITY_OR_OTHER|||||||0.024|||||||Fisher's non-parametric permutation test|||24 months Speech in Quiet at 65dB||||0.024
72483995|NCT02022085|144494761|SUPERIORITY_OR_OTHER|||||||0.59|||||||Fisher's non-parametric permutation test|||24 months Speech in Quiet at 80dB||||0.59
72483996|NCT02022085|144494762|SUPERIORITY_OR_OTHER|||||||0.088|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||6 months change in Comprehensive health state||||0.088
72483997|NCT02022085|144494762|SUPERIORITY_OR_OTHER|||||||0.88|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||6 months change in Vision||||0.88
72483998|NCT02022085|144494762|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||6 months change in Hearing||||0.020
72483999|NCT02022085|144494762|SUPERIORITY_OR_OTHER|||||||0.039|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||6 months change in Speech||||0.039
72567304|NCT00518882|144665558|SUPERIORITY_OR_OTHER||LS Mean|1.01||||0.0005||95.0|0.44|1.57||There were no multiplicity concerns.|ANCOVA|||ANCOVA model included treatment, country and previous treatment as fixed effects and baseline value of the endpoint as covariate. The objective was to demonstrate that treatment with liraglutide was different from treatment with exenatide. Thus the null hypothesis and its alternative were H0: µliraglutide = µexenatide against HA1:µliraglutide ≠ µexenatide where µliraglutide and µexenatide is the mean value of the endpoint in the liraglutide arm and exenatide arm, respectively.||1.57|0.44|0.0005
72484000|NCT02022085|144494762|SUPERIORITY_OR_OTHER|||||||0.25|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||6 months change in Ambulation||||0.25
72484001|NCT02022085|144494762|SUPERIORITY_OR_OTHER|||||||0.38|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||6 months change in Dexterity||||0.38
72484002|NCT02022085|144494762|SUPERIORITY_OR_OTHER|||||||0.43|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||6 months change in Emotion||||0.43
72484003|NCT02022085|144494762|SUPERIORITY_OR_OTHER|||||||0.85|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||6 months change in Cognition||||0.85
72512050|NCT02065622|144554193|SUPERIORITY||Adjusted risk difference|15.9||||0.161|TWO_SIDED|95.0|-6.3|38.2|||Cochran-Mantel-Haenszel||Risk difference = Adalimumab 40mg EW - Adalimumab 40mg EOW.|Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel (CMH) test adjusted for induction treatment regimen and week 8 remission status.||38.2|-6.3|0.161
72512051|NCT02065622|144554193|SUPERIORITY||Adjusted risk difference|10.4||||0.312|TWO_SIDED|95.0|-9.8|30.6|||Cochran-Mantel-Haenszel||Risk difference = Adalimumab 40mg EW - Adalimumab 40mg EOW.|Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel (CMH) test adjusted for induction treatment regimen and week 8 remission status.||30.6|-9.8|0.312
72512052|NCT02065622|144554194|SUPERIORITY||Adjusted risk difference|12.3||||0.272|TWO_SIDED|95.0|-9.7|34.4|||Cochran-Mantel-Haenszel||Risk difference = Adalimumab 40mg EW - Adalimumab 40mg EOW.|Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel (CMH) test adjusted for induction treatment regimen and week 8 remission status.||34.4|-9.7|0.272
72567305|NCT00518882|144665559|SUPERIORITY_OR_OTHER||Mean|-0.22|STANDARD_DEVIATION|2.866||0.2972||95.0|-0.626|0.192|||Paired t test|||A paired t test was made within the group and 95% confidence intervals for the difference between Weeks 26 and 78 were constructed. H0 was µ78 - µ26 = 0 against HA: µ78 - µ26 ≠ 0. A difference between the two means (Week 26 and Week 78) was concluded when H0 was rejected at the 5% level.||0.192|-0.626|0.2972
72484004|NCT02022085|144494762|SUPERIORITY_OR_OTHER|||||||0.25|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||6 months change in Pain||||0.25
72484005|NCT02022085|144494762|SUPERIORITY_OR_OTHER|||||||0.088|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||24 months change in Comprehensive health state||||0.088
72484006|NCT02022085|144494762|SUPERIORITY_OR_OTHER|||||||0.63|||||||Fisher's non-parametric permutation test|||24 months change in Vision||||0.63
72484007|NCT02022085|144494762|SUPERIORITY_OR_OTHER|||||||0.045|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||24 months change in Hearing||||0.045
72484008|NCT02022085|144494762|SUPERIORITY_OR_OTHER|||||||0.016|||||||Fisher's non-parametric permutation test|||24 months change in Speech||||0.016
72484009|NCT02022085|144494762|SUPERIORITY_OR_OTHER|||||||0.25|||||||Fisher's non-parametric permutation test|||24 months change in Ambulation||||0.25
72484010|NCT02022085|144494762|SUPERIORITY_OR_OTHER|||||||0.5|||||||Wilcoxan Signed Rank Test|Fisher's non-parametric permutation test failed to approximate p value so Wilcoxan Signed Rank Test instead||24 months change in Dexterity||||0.50
72484011|NCT02022085|144494762|SUPERIORITY_OR_OTHER|||||||0.29|||||||Fisher's non-parametric permutation test|||24 months change in Emotion||||0.29
72484012|NCT02022085|144494762|SUPERIORITY_OR_OTHER|||||||0.92|||||||Fisher's non-parametric permutation test|||24 months change in Cognition||||0.92
72484013|NCT02022085|144494762|SUPERIORITY_OR_OTHER|||||||0.02|||||||Fisher's non-parametric permutation test|||24 months change in Pain||||0.020
72484014|NCT02022085|144494763|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||6 months: Ease of communication||||<0.0001
72484015|NCT02022085|144494763|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||6 months: Background noise||||<0.0001
72484016|NCT02022085|144494763|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Fisher's non-parametric permutation test|||6 months: Reverberation||||<0.0001
72484017|NCT02022085|144494763|SUPERIORITY_OR_OTHER|||||||0.69|||||||Fisher's non-parametric permutation test|||6 months: Aversiveness||||0.69
72484018|NCT02022085|144494763|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Fisher's non-parametric permutation test|||6 months: Global||||<0.0001
72402383|NCT01480076|144311676|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 12, RRMS. Mixed effect model for repeated measures with visit, baseline PCS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
72484019|NCT02022085|144494763|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Fisher's non-parametric permutation test|||24 months: Ease of communication||||<0.001
72484020|NCT02022085|144494763|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Fisher's non-parametric permutation test|||24 months: Background noise||||<0.001
72484021|NCT02022085|144494763|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Fisher's non-parametric permutation test|||24 months: Reverberation||||<0.001
72484022|NCT02022085|144494763|SUPERIORITY_OR_OTHER|||||||0.84|||||||Fisher's non-parametric permutation test|||24 months: Aversiveness||||0.84
72484023|NCT02022085|144494763|SUPERIORITY_OR_OTHER||Fisher's non-parametric permutation test||||<|0.001|||||||Fisher's non-parametric permutation test|||24 months: Global||||<0.001
72484024|NCT02022085|144494764|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Speech: Change from pre-op to 6 months||||<0.0001
72484025|NCT02022085|144494764|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Fisher's non-parametric permutation test|||Spatial: Change from pre-op to 6 months||||<0.0001
72484026|NCT02022085|144494764|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Fisher's non-parametric permutation test|||Qualities: Change from pre-op to 6 months||||<0.0001
72484027|NCT02022085|144494764|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Fisher's non-parametric permutation test|||Speech: Change from pre-op to 24 months||||<0.0001
72484028|NCT02022085|144494764|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Fisher's non-parametric permutation test|||Spatial: Change from pre-op to 24 months||||<0.0001
72484029|NCT02022085|144494764|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Fisher's non-parametric permutation test|||Qualities: Change from pre-op to 24 months||||<0.0001
72512053|NCT02065622|144554194|SUPERIORITY||Adjusted risk difference|5.3||||0.6|TWO_SIDED|95.0|-14.6|25.2|||Cochran-Mantel-Haenszel||Risk difference = Adalimumab 40mg EW - Adalimumab 40mg EOW.|Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel (CMH) test adjusted for induction treatment regimen and week 8 remission status.||25.2|-14.6|0.600
72512054|NCT02065622|144554195|SUPERIORITY||Adjusted risk difference|23.8||||0.074|TWO_SIDED|95.0|-2.3|49.9|||Cochran-Mantel-Haenszel||Risk difference = Adalimumab 40mg EW - Adalimumab 40mg EOW.|Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel (CMH) test adjusted for induction treatment regimen and week 8 remission status.||49.9|-2.3|0.074
72567306|NCT00518882|144665559|SUPERIORITY_OR_OTHER||Mean|1.15|STANDARD_DEVIATION|3.253|<|0.0001||95.0|0.66|1.637|||Paired t test|||A paired t test was made within the group and 95% confidence intervals for the difference between Weeks 26 and 78 were constructed. H0 was µ78 - µ26 = 0 against HA: µ78 - µ26 ≠ 0. A difference between the two means (Week 26 and Week 78) was concluded when H0 was rejected at the 5% level.||1.637|0.660|<0.0001
72567307|NCT00518882|144665560|SUPERIORITY_OR_OTHER||Mean|0.05|STANDARD_DEVIATION|3.307||0.8396||95.0|-0.424|0.521|||Paired t test|||A paired t test was made within the group and 95% confidence intervals for the difference between Weeks 26 and 78 were constructed. H0 was µ78 - µ26 = 0 against HA: µ78 - µ26 ≠ 0. A difference between the two means (Week 26 and Week 78) was concluded when H0 was rejected at the 5% level.||0.521|-0.424|0.8396
72484030|NCT01179672|144494773|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.43||||0.03|TWO_SIDED|95.0|-0.82|-0.04|||Mixed Models Analysis|||||-0.04|-0.82|0.030
72484031|NCT01179672|144494774|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.54||||0.008|TWO_SIDED|95.0|-0.95|-0.14||P-value is for mean change from baseline to 12-week endpoint in night pain.|Mixed Models Analysis|||||-0.14|-0.95|0.008
72484032|NCT01179672|144494774|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.55||||0.017|TWO_SIDED|95.0|-1.0|-0.1||P-value is for mean change from baseline to 12 week endpoint in worst pain.|Mixed Models Analysis|||||-0.10|-1.00|0.017
72484033|NCT01179672|144494775|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5||||0.016|TWO_SIDED|95.0|-0.9|-0.09|||Mixed Models Analysis|||||-0.09|-0.90|0.016
72484034|NCT01179672|144494776|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.23||||0.081|TWO_SIDED|95.0|-0.48|0.03|||Mixed Models Analysis|||||0.03|-0.48|0.081
72484035|NCT01179672|144494777|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.21||||0.034|TWO_SIDED|95.0|-0.4|-0.02|||Mixed Models Analysis|||||-0.02|-0.40|0.034
72484036|NCT01179672|144494778|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.12||||0.022|TWO_SIDED|95.0|-2.07|-0.16|||ANCOVA|ANCOVA adjusted for treatment, pooled investigator and baseline.||||-0.16|-2.07|0.022
72484037|NCT01179672|144494779|SUPERIORITY_OR_OTHER|||||||0.014||||||P-value is for ≥30% reduction in 24-hour average pain.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test was stratified by pooled investigator.||||||0.014
72484038|NCT01179672|144494779|SUPERIORITY_OR_OTHER|||||||0.006||||||P-value is for ≥50% reduction in 24-hour average pain.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test was stratified by pooled investigator.||||||0.006
72484039|NCT01179672|144494779|SUPERIORITY_OR_OTHER|||||||0.193||||||P-value is for ≥75% reduction in 24-hour average pain.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test was stratified by pooled investigator.||||||0.193
72484040|NCT01179672|144494780|SUPERIORITY_OR_OTHER|||||||0.003||||||P-value is for ≥30% reduction in 24-hour BPI-Severity average pain.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test was stratified by pooled investigator.||||||0.003
72484041|NCT01179672|144494780|SUPERIORITY_OR_OTHER|||||||0.001||||||P-value is for ≥50% reduction in 24-hour BPI-Severity average pain.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test was stratified by pooled investigator.||||||0.001
72484042|NCT01179672|144494780|SUPERIORITY_OR_OTHER|||||||0.168||||||P-value is for ≥75% reduction in 24-hour BPI-Severity average pain.|Cochran-Mantel-Haenszel|Cochran Mantel Haenszel test was stratified by pooled investigator.||||||0.168
72484043|NCT01179672|144494781|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6||||0.001|TWO_SIDED|95.0|-0.96|-0.24|||Mixed Models Analysis|||||-0.24|-0.96|0.001
72484044|NCT01179672|144494782|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.26||||0.02|TWO_SIDED|95.0|-2.33|-0.2|||Mixed Models Analysis|||||-0.20|-2.33|0.020
72484045|NCT02748018|144494784|SUPERIORITY|Test of Treatment Effect on Change in A1C with Multiple Imputation|Mean Difference (Final Values)|-0.8|||||ONE_SIDED|97.5||-0.4||||||||-0.4||
72402384|NCT01480076|144311676|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 12, SPMS. Mixed effect model for repeated measures with visit, baseline PCS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
72402385|NCT01480076|144311676|SUPERIORITY_OR_OTHER|||||||0.0047|||||||mixed effect model|||Month 12, PPMS. Mixed effect model for repeated measures with visit, baseline PCS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.0047
72402386|NCT01480076|144311676|SUPERIORITY_OR_OTHER|||||||0.0118|||||||mixed effect model|||Month 12, PRMS. Mixed effect model for repeated measures with visit, baseline PCS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.0118
72484046|NCT02748018|144494785|SUPERIORITY|Test of Treatment Effect on Time in Hypoglycemic Range (%)|Mean Difference (Final Values)|-4.9|||||ONE_SIDED|97.5||-3.6||||||||-3.6||
72484047|NCT02748018|144494786|SUPERIORITY|Test of Treatment Effect on Change in A1C with Multiple Imputation|Mean Difference (Final Values)|-0.7|||||ONE_SIDED|97.5||-0.3||||||||-0.3||
72484048|NCT02748018|144494787|SUPERIORITY|Test of Treatment Effect on Time in Hypoglycemic Range (%)|Mean Difference (Final Values)|-4.8|||||ONE_SIDED|97.5||-3.1||||||||-3.1||
72512055|NCT02065622|144554195|SUPERIORITY||Adjusted risk difference|15.0||||0.21|TWO_SIDED|95.0|-8.5|38.4|||Cochran-Mantel-Haenszel||Risk difference = Adalimumab 40mg EW - Adalimumab 40mg EOW.|Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel (CMH) test adjusted for induction treatment regimen and week 8 remission status.||38.4|-8.5|0.210
72512056|NCT02065622|144554196|SUPERIORITY||Adjusted risk difference|20.0||||0.151|TWO_SIDED|95.0|-7.3|47.3|||Cochran-Mantel-Haenszel||Risk difference = Adalimumab 40mg EW - Adalimumab 40mg EOW.|Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel (CMH) test adjusted for induction treatment regimen and week 8 remission status.||47.3|-7.3|0.151
72512057|NCT02065622|144554196|SUPERIORITY||Adjusted risk difference|12.8||||0.299|TWO_SIDED|95.0|-11.3|36.8|||Cochran-Mantel-Haenszel||Risk difference = Adalimumab 40mg EW - Adalimumab 40mg EOW.|Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel (CMH) test adjusted for induction treatment regimen and week 8 remission status.||36.8|-11.3|0.299
72512058|NCT02065622|144554197|SUPERIORITY||Adjusted risk difference|4.5||||0.422|TWO_SIDED|95.0|-6.4|15.3|||Cochran-Mantel-Haenszel||Risk difference = Adalimumab 40mg EW - Adalimumab 40mg EOW.|Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel (CMH) test adjusted for induction treatment regimen and week 8 remission status.||15.3|-6.4|0.422
72512059|NCT02065622|144554197|SUPERIORITY||Adjusted risk difference|3.4||||0.513|TWO_SIDED|95.0|-6.8|13.6|||Cochran-Mantel-Haenszel||Risk difference = Adalimumab 40mg EW - Adalimumab 40mg EOW.|Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel (CMH) test adjusted for induction treatment regimen and week 8 remission status.||13.6|-6.8|0.513
72567308|NCT00518882|144665560|SUPERIORITY_OR_OTHER||Mean|-0.09|STANDARD_DEVIATION|3.419||0.7278||95.0|-0.604|0.423|||Paired t test|||A paired t test was made within the group and 95% confidence intervals for the difference between Weeks 26 and 78 were constructed. H0 was µ78 - µ26 = 0 against HA: µ78 - µ26 ≠ 0. A difference between the two means (Week 26 and Week 78) was concluded when H0 was rejected at the 5% level.||0.423|-0.604|0.7278
72402387|NCT01480076|144311677|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Overall, RRMS. Mixed effect model for repeated measures with visit, baseline MCS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
72402388|NCT01480076|144311677|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Overall, SPMS. Mixed effect model for repeated measures with visit, baseline MCS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
72484049|NCT02748018|144494788|SUPERIORITY|Test of Treatment Effect on Change in A1C with Multiple Imputation|Mean Difference (Final Values)|0.0|||||ONE_SIDED|97.5||0.3||||||||0.3||
72484050|NCT02748018|144494789|SUPERIORITY|Test of Treatment Effect on Time in Hypoglycemic Range (%)|Mean Difference (Final Values)|-1.0|||||ONE_SIDED|97.5||-0.2||||||||-0.2||
72484051|NCT02748018|144494790|NON_INFERIORITY|Non-inferiority margin: 2%. Test of Treatment Effect on Time in Hypoglycemic Range (%)|Mean Difference (Final Values)|-2.2|||||ONE_SIDED|97.5||-0.9||||||||-0.9||
72484052|NCT02748018|144494791|NON_INFERIORITY|Non-inferiority margin: 0.4%. Treatment Effect on Change in A1C with Multiple Imputation|Mean Difference (Final Values)|-0.3|||||ONE_SIDED|97.5||-0.1||||||||-0.1||
72484053|NCT02748018|144494792|SUPERIORITY|Test of Treatment Effect on Time in Hypoglycemic Range (%) During Night|Mean Difference (Final Values)|-5.4|||||ONE_SIDED|97.5||-3.7||||||||-3.7||
72484054|NCT02748018|144494793|SUPERIORITY|Test of Treatment Effect on Time in Target Range (%) During Night|Mean Difference (Final Values)|18.8|||||ONE_SIDED|97.5|14.5||||||||||14.5|
72512060|NCT02065622|144554198|SUPERIORITY||Adjusted risk difference|3.7||||0.351|TWO_SIDED|95.0|-4.1|11.4|||Cochran-Mantel-Haenszel||Risk difference = Adalimumab 40mg EW - Adalimumab 40mg EOW.|Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel (CMH) test adjusted for induction treatment regimen and week 8 remission status.||11.4|-4.1|0.351
72512061|NCT02065622|144554198|SUPERIORITY||Adjusted risk difference|3.9||||0.292|TWO_SIDED|95.0|-3.3|11.1|||Cochran-Mantel-Haenszel||Risk difference = Adalimumab 40mg EW - Adalimumab 40mg EOW.|Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel (CMH) test adjusted for induction treatment regimen and week 8 remission status.||11.1|-3.3|0.292
72567309|NCT00518882|144665561|SUPERIORITY_OR_OTHER||Mean|0.22|STANDARD_DEVIATION|3.053||0.3271||95.0|-0.219|0.654|||Paired t test|||A paired t test was made within the group and 95% confidence intervals for the difference between Weeks 26 and 78 were constructed. H0 was µ78 - µ26 = 0 against HA: µ78 - µ26 ≠ 0. A difference between the two means (Week 26 and Week 78) was concluded when H0 was rejected at the 5% level.||0.654|-0.219|0.3271
72567310|NCT00518882|144665561|SUPERIORITY_OR_OTHER||Mean|1.07|STANDARD_DEVIATION|3.775||0.0003||95.0|0.497|1.634|||Paired t test|||A paired t test was made within the group and 95% confidence intervals for the difference between Weeks 26 and 78 were constructed. H0 was µ78 - µ26 = 0 against HA: µ78 - µ26 ≠ 0. A difference between the two means (Week 26 and Week 78) was concluded when H0 was rejected at the 5% level.||1.634|0.497|0.0003
72567311|NCT00518882|144665562|SUPERIORITY_OR_OTHER||Mean|-1.08|STANDARD_DEVIATION|3.662|<|0.0001||95.0|-1.605|-0.562|||Paired t test|||The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 0 and 78 were constructed. H0 was µ78- µ0=0 against HA: µ78 - µ0 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.||-0.562|-1.605|<0.0001
72567312|NCT00518882|144665562|SUPERIORITY_OR_OTHER||Mean|-0.99|STANDARD_DEVIATION|3.467||0.0003||95.0|-1.517|-0.458|||Paired t test|||The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 0 and 78 were constructed. H0 was µ78- µ0=0 against HA: µ78 - µ0 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.||-0.458|-1.517|0.0003
72567313|NCT00518882|144665563|SUPERIORITY_OR_OTHER||Mean|0.26|STANDARD_DEVIATION|4.158||0.3859||95.0|-0.331|0.853|||Paired t test|||The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 0 and 78 were constructed. H0 was µ78- µ0=0 against HA: µ78 - µ0 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.||0.853|-0.331|0.3859
72484055|NCT02748018|144494794|SUPERIORITY|Test of Treatment Effect on Time in Target Range (%)|Mean Difference (Final Values)|12.0|||||ONE_SIDED|97.5|8.8||||||||||8.8|
72484056|NCT02748018|144494795|SUPERIORITY|Test of Treatment Effect on Time in Hypoglycemic Range (%)|Mean Difference (Final Values)|-3.6|||||ONE_SIDED|97.5||-2.6||||||||-2.6||
72484057|NCT02748018|144494796|SUPERIORITY|Treatment Effect on Change in A1C with Multiple Imputation|Mean Difference (Final Values)|-0.6|||||ONE_SIDED|97.5||-0.3||||||||-0.3||
72567314|NCT00518882|144665563|SUPERIORITY_OR_OTHER||Mean|-0.37|STANDARD_DEVIATION|3.838||0.2119||95.0|-0.956|0.214|||Paired t test|||The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 0 and 78 were constructed. H0 was µ78- µ0=0 against HA: µ78 - µ0 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.||0.214|-0.956|0.2119
72567315|NCT00518882|144665564|SUPERIORITY_OR_OTHER||Mean|-0.35|STANDARD_DEVIATION|3.975||0.229||95.0|-0.917|0.2211|||Paired t test|||The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 0 and 78 were constructed. H0 was µ78- µ0=0 against HA: µ78 - µ0 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.||0.2211|-0.917|0.2290
72402389|NCT01480076|144311677|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Overall, PPMS. Mixed effect model for repeated measures with visit, baseline MCS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
72484058|NCT02748018|144494797|NON_INFERIORITY|Non-inferiority margin: 2%. Test of Treatment Effect on Time in Hypoglycemic Range (%)|Mean Difference (Final Values)|-3.6|||||ONE_SIDED|97.5||-1.9||||||||-1.9||
72484059|NCT02748018|144494798|NON_INFERIORITY|Non-inferiority margin: 0.4%. Treatment Effect on Change in A1C with Multiple Imputation|Mean Difference (Final Values)|0.1|||||ONE_SIDED|97.5||0.3||||||||0.3||
72484060|NCT02748018|144494799|SUPERIORITY|Test of Treatment Effect on Time in Hypoglycemic Range (%) during Night|Mean Difference (Final Values)|-7.3|||||ONE_SIDED|97.5||-4.7||||||||-4.7||
72567316|NCT00518882|144665564|SUPERIORITY_OR_OTHER||Mean|-0.95|STANDARD_DEVIATION|3.23||0.0002||95.0|-1.449|-0.459|||Paired t test|||The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 0 and 78 were constructed. H0 was µ78- µ0=0 against HA: µ78 - µ0 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.||-0.459|-1.449|0.0002
72567317|NCT00518882|144665565|SUPERIORITY_OR_OTHER||Estimated treatment difference, LS Mean|0.73||||0.0124||95.0|0.16|1.31||There were no multiplicity concerns.|ANCOVA|||ANCOVA model included treatment, country and previous treatment as fixed effects and baseline value of the endpoint as covariate. The objective was to demonstrate that treatment with liraglutide was different from treatment with exenatide. Thus the null hypothesis and its alternative were H0: µliraglutide = µexenatide against HA1:µliraglutide ≠ µexenatide where µliraglutide and µexenatide is the mean value of the endpoint in the liraglutide arm and exenatide arm, respectively.||1.31|0.16|0.0124
72624074|NCT03537508|144778466|NON_INFERIORITY|The overall non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI was \>-10% for all 4 serogroups. 95% CI of the difference was calculated from the Wilson Score method without continuity correction.|Difference in Percentage of Participants|5.72|||||TWO_SIDED|95.0|3.44|8.57||||||Statistical analysis for Serogroup W||8.57|3.44|
72484061|NCT02748018|144494800|SUPERIORITY|Test of Treatment Effect on Time in Target Range (%) during Night|Mean Difference (Final Values)|15.9|||||ONE_SIDED|97.5|11.1||||||||||11.1|
72484062|NCT02748018|144494801|SUPERIORITY|Test of Treatment Effect on Time in Target Range (%)|Mean Difference (Final Values)|13.6|||||ONE_SIDED|97.5|9.9||||||||||9.9|
72484063|NCT02748018|144494802|SUPERIORITY|Test of Treatment Effect on Time in Hypoglycemic Range (%)|Mean Difference (Final Values)|-4.3|||||ONE_SIDED|97.5||-3.1||||||||-3.1||
72484064|NCT02748018|144494803|SUPERIORITY|Treatment Effect on Change in A1C with Multiple Imputation|Mean Difference (Final Values)|-0.2|||||ONE_SIDED|97.5||0.0||||||||0.0||
72484065|NCT02748018|144494804|NON_INFERIORITY|Non-inferiority margin: 2%. Treatment Effect on Time in Hypoglycemic Range (%) with Multiple Imputation|Mean Difference (Final Values)|-0.3|||||ONE_SIDED|97.5||0.7||||||||0.7||
72484066|NCT02748018|144494805|NON_INFERIORITY|Non-inferiority margin: 0.4%. Treatment Effect on Change in A1C with Multiple Imputation|Mean Difference (Final Values)|0.0|||||ONE_SIDED|97.5||0.1||||||||0.1||
72484067|NCT02748018|144494806|SUPERIORITY|Test of Treatment Effect on Time in Hypoglycemic Range (%) during Night|Mean Difference (Final Values)|-0.7|||||ONE_SIDED|97.5||0.2||||||||0.2||
72512062|NCT02065622|144554199|SUPERIORITY||Adjusted risk difference|5.4||||0.121|TWO_SIDED|95.0|-1.4|12.1|||Cochran-Mantel-Haenszel||Risk difference = Adalimumab 40mg EW - Adalimumab 40mg EOW.|Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel (CMH) test adjusted for induction treatment regimen and week 8 remission status.||12.1|-1.4|0.121
72512063|NCT02065622|144554199|SUPERIORITY||Adjusted risk difference|6.5||||0.046|TWO_SIDED|95.0|0.1|12.8|||Cochran-Mantel-Haenszel||Risk difference = Adalimumab 40mg EW - Adalimumab 40mg EOW.|Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel (CMH) test adjusted for induction treatment regimen and week 8 remission status.||12.8|0.1|0.046
72512064|NCT02065622|144554200|SUPERIORITY||Adjusted risk difference|7.5||||0.159|TWO_SIDED|95.0|-2.9|17.9|||Cochran-Mantel-Haenszel||Risk difference = Adalimumab 40mg EW - Adalimumab 40mg EOW.|Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel (CMH) test adjusted for induction treatment regimen and week 8 remission status.||17.9|-2.9|0.159
72512065|NCT02065622|144554200|SUPERIORITY||Adjusted risk difference|8.0||||0.109|TWO_SIDED|95.0|-1.8|17.9|||Cochran-Mantel-Haenszel||Risk difference = Adalimumab 40mg EW - Adalimumab 40mg EOW.|Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel (CMH) test adjusted for induction treatment regimen and week 8 remission status.||17.9|-1.8|0.109
72484068|NCT02748018|144494807|SUPERIORITY|Test of Treatment Effect on Time in Target Range (%) during Night|Mean Difference (Final Values)|12.2|||||ONE_SIDED|97.5|8.3||||||||||8.3|
72484069|NCT02748018|144494808|SUPERIORITY|Test of Treatment Effect on Time in Target Range (%)|Mean Difference (Final Values)|6.3|||||ONE_SIDED|97.5|3.3||||||||||3.3|
72484070|NCT02748018|144494809|SUPERIORITY|Test of Treatment Effect on Time in Hypoglycemic Range (%)|Mean Difference (Final Values)|-0.8|||||ONE_SIDED|97.5||-0.1||||||||-0.1||
72484071|NCT02748018|144494810|SUPERIORITY|Treatment Effect on Change in A1C with Multiple Imputation|Mean Difference (Final Values)|0.0|||||ONE_SIDED|97.5||0.1||||||||0.1||
72484072|NCT02019420|144494821|NON_INFERIORITY|Difference in ITT all-cause mortality (linezolid - tedizolid). Noninferiority is declared when the lower bound of the 95% CI \> -10.|Difference in all-cause mortality|-1.8|||||TWO_SIDED|95.0|-8.2|4.7|||||Difference and 95% CI were calculated with the Miettinen and Nurminen method without stratification.|||4.7|-8.2|
72512066|NCT02065622|144554201|SUPERIORITY||Adjusted risk difference|1.4||||0.903|TWO_SIDED|95.0|-21.0|23.8|||Cochran-Mantel-Haenszel||Risk difference = Adalimumab 40mg EW - Adalimumab 40mg EOW.|Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel (CMH) test adjusted for induction treatment regimen and week 8 remission status.||23.8|-21.0|0.903
72512067|NCT02065622|144554201|SUPERIORITY||Adjusted risk difference|1.3||||0.901|TWO_SIDED|95.0|-18.8|21.3|||Cochran-Mantel-Haenszel||Risk difference = Adalimumab 40mg EW - Adalimumab 40mg EOW.|Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel (CMH) test adjusted for induction treatment regimen and week 8 remission status.||21.3|-18.8|0.901
72484073|NCT02019420|144494822|OTHER|Difference in mITT all-cause mortality (linezolid - tedizolid)|Difference in all-cause mortality|-1.6|||||TWO_SIDED|95.0|-10.3|7.1|||||Difference and 95% CI were calculated with the Miettinen and Nurminen method without stratification.|||7.1|-10.3|
72484074|NCT02019420|144494823|OTHER|Difference in ITT clinical success (tedizolid - linezolid)|Difference in clinical success|-7.6|||||TWO_SIDED|95.0|-14.7|-0.5|||||Difference and 95% CI were calculated with the Miettinen and Nurminen method without stratification.|||-0.5|-14.7|
72484075|NCT02019420|144494824|OTHER|Difference in CE clinical success (tedizolid - linezolid)|Difference in clinical success|-6.5|||||TWO_SIDED|95.0|-15.1|2.1|||||Difference and 95% CI were calculated with the Miettinen and Nurminen method without stratification.|||2.1|-15.1|
72484076|NCT02019420|144494825|OTHER|Difference in MSSA mITT all-cause mortality (linezolid - tedizolid)|Difference in all-cause mortality|-1.5|||||TWO_SIDED|95.0|-12.5|9.5|||||Difference and 95% CI were calculated with the Miettinen and Nurminen method without stratification.|||9.5|-12.5|
72484077|NCT02019420|144494826|OTHER|Difference in MRSA mITT all-cause mortality (linezolid - tedizolid)|Difference in all-cause mortality|3.1|||||TWO_SIDED|95.0|-12.8|18.9|||||Difference and 95% CI were calculated with the Miettinen and Nurminen method without stratification.|||18.9|-12.8|
72484078|NCT02019420|144494827|OTHER|Difference in mITT favorable response (tedizolid - linezolid)|Difference in clinical success|-13.1|||||TWO_SIDED|95.0|-21.7|-4.5|||||Difference and 95% CI were calculated with the Miettinen and Nurminen method without stratification.|||-4.5|-21.7|
72484079|NCT02019420|144494828|OTHER|Difference in ME-1 favorable response (tedizolid - linezolid)|Difference in clinical success|-13.1|||||TWO_SIDED|95.0|-21.7|-4.5|||||Difference and 95% CI were calculated with the Miettinen and Nurminen method without stratification.|||-4.5|-21.7|
72512068|NCT02065622|144554202|SUPERIORITY||Adjusted risk difference|7.7||||0.16|TWO_SIDED|95.0|-3.0|18.4|||Cochran-Mantel-Haenszel||Risk difference = Adalimumab 40mg EW - Adalimumab 40mg EOW.|Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel (CMH) test adjusted for induction treatment regimen and week 8 remission status.||18.4|-3.0|0.160
72512069|NCT02065622|144554202|SUPERIORITY||Adjusted risk difference|9.1||||0.076|TWO_SIDED|95.0|-0.9|19.1|||Cochran-Mantel-Haenszel||Risk difference = Adalimumab 40mg EW - Adalimumab 40mg EOW.|Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel (CMH) test adjusted for induction treatment regimen and week 8 remission status.||19.1|-0.9|0.076
72512070|NCT02065622|144554203|SUPERIORITY||Adjusted risk difference|7.3||||0.207|TWO_SIDED|95.0|-4.0|18.6|||Cochran-Mantel-Haenszel||Risk difference = Adalimumab 40mg EW - Adalimumab 40mg EOW.|Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel (CMH) test adjusted for induction treatment regimen and week 8 remission status.||18.6|-4.0|0.207
72484080|NCT02019420|144494829|OTHER|Difference in mITT favorable response (tedizolid - linezolid)|Difference in clinical success|-12.5|||||TWO_SIDED|95.0|-21.5|-3.5|||||Difference and 95% CI were calculated with the Miettinen and Nurminen method without stratification.|||-3.5|-21.5|
72484081|NCT02019420|144494830|OTHER|Difference in ME-2 favorable response (tedizolid - linezolid)|Difference in clinical success|-13.7|||||TWO_SIDED|95.0|-26.2|-1.2|||||Difference and 95% CI were calculated with the Miettinen and Nurminen method without stratification.|||-1.2|-26.2|
72484082|NCT02510560|144494833|SUPERIORITY|||||||0.115|||||||Stratified Van Elteren Test|||||||0.115
72484083|NCT02510560|144494833|SUPERIORITY|||||||0.243|||||||Stratified Van Elteren Test|||||||0.243
72484084|NCT02510560|144494834|SUPERIORITY|||||||0.714|||||||Stratified Van Elteren Test|||||||0.714
72484085|NCT02510560|144494834|SUPERIORITY|||||||0.243|||||||Stratified Van Elteren Test|||||||0.243
72484086|NCT02554903|144494835|SUPERIORITY||Geometric Mean Ratio|0.7393||||0.0158|TWO_SIDED|95.0|0.5798|0.9426|||ANCOVA|||||0.9426|0.5798|0.0158
72484087|NCT03739437|144494914|SUPERIORITY|||||||0.384|||||||Chi-squared|||||||0.384
72484088|NCT03951220|144494968|SUPERIORITY|||||||0.7343|||||||ANOVA|||||||0.7343
72484089|NCT03951220|144494969|OTHER|Correlation|Spearman (r)|0.39||||0.0445|TWO_SIDED|95.0|0.0|0.68|||Spearman's rank correlation coeffcieitn|||||0.68|0.00|0.0445
72484090|NCT03951220|144494970|SUPERIORITY|||||||0.0079||||||Dunn's multiple comparisons test|Kruskal-Wallis|||For baseline P1NP||||0.0079
72484091|NCT03951220|144494970|SUPERIORITY|||||||0.0482||||||Dunn's multiple comparison test|ANOVA|||For baseline sclerostin||||0.0482
72484092|NCT03951220|144494981|OTHER|||||||0.015|||||||Fisher-Freeman-Halton exact test|||||||0.015
72484093|NCT03951220|144494984|OTHER|||||||0.007|||||||Mann-Whitney test|||||||0.007
72484094|NCT02499770|144495034|OTHER||||||=|0.0097||||||The p-value was calculated using the stratified log-rank test to account for the baseline ECOG status (0-1 vs 2) as the stratification factor. Significance level was set as two-sided 0.2.|Stratified log-rank test|p-value calculated using stratified log-rank test with baseline ECOG status (0-1 vs 2) as stratification factor. Significance level was two-sided 0.2.||||||= 0.0097
72624075|NCT04983979|144778490|OTHER||Risk Difference (RD)|-0.1|||||TWO_SIDED|95.0|-0.752|0.552||||||Due to the small sample size only an estimate of the difference between study arms was generated. No hypothesis tests were completed.||0.552|-0.752|
72484095|NCT02564926|144495085|OTHER||LS mean difference (kg)|-2.6|||<|0.001|TWO_SIDED|95.0|-3.346|-1.819|||ANCOVA|||||-1.819|-3.346|<0.001
72484096|NCT02564926|144495086|OTHER||LS mean difference (%)|-0.46||||0.014|TWO_SIDED|95.0|-0.821|-0.094|||Mixed Models Analysis|||||-0.094|-0.821|0.014
72484097|NCT02564926|144495087|OTHER||Odds Ratio (OR)|1.45||||0.343|TWO_SIDED|95.0|0.673|3.113|||Regression, Logistic|||||3.113|0.673|0.343
72484098|NCT02564926|144495088|OTHER||LS mean difference (mg/dL)|-18.25||||0.006|TWO_SIDED|95.0|-31.14|-5.351|||Mixed Models Analysis|||||-5.351|-31.140|0.006
72484099|NCT02564926|144495089|OTHER||LS mean difference (kg)|-3.7|||<|0.001|TWO_SIDED|95.0|-4.667|-2.631|||Mixed Models Analysis|||||-2.631|-4.667|<0.001
72484100|NCT02564926|144495090|OTHER||LS mean difference (cm)|-2.21||||0.006|TWO_SIDED|95.0|-3.785|-0.635|||Mixed Models Analysis|||||-0.635|-3.785|0.006
72484101|NCT02564926|144495091|OTHER||LS mean difference (kg/m2)|-1.37|||<|0.001|TWO_SIDED|95.0|-1.742|-0.99|||Mixed Models Analysis|||||-0.990|-1.742|<0.001
72484102|NCT02564926|144495092|OTHER||LS mean difference (mmHg)|-6.81||||0.002|TWO_SIDED|95.0|-10.969|-2.641|||Mixed Models Analysis|||||-2.641|-10.969|0.002
72484103|NCT02564926|144495093|OTHER||LS mean difference (mmHg)|-2.61||||0.11|TWO_SIDED|95.0|-5.829|0.6|||Mixed Models Analysis|||||0.600|-5.829|0.110
72484104|NCT02564926|144495094|OTHER||LS mean difference (cm2)|-17.55||||0.002|TWO_SIDED|95.0|-28.603|-6.489|||ANCOVA|||||-6.489|-28.603|0.002
72484105|NCT02564926|144495095|OTHER||LS mean difference (cm2)|-18.39|||<|0.001|TWO_SIDED|95.0|-27.561|-9.218|||ANCOVA|||||-9.218|-27.561|<0.001
72484106|NCT02564926|144495096|OTHER||LS mean difference|-0.03||||0.503|TWO_SIDED|95.0|-0.127|0.063|||ANCOVA|||||0.063|-0.127|0.503
72484107|NCT02564926|144495097|OTHER||LS mean difference|-1.3|||<|0.001|TWO_SIDED|95.0|-1.992|-0.54|||ANCOVA|||||-0.540|-1.992|<0.001
72484108|NCT02564926|144495098|OTHER||LS mean difference (ng/mL)|657.71||||0.044|TWO_SIDED|95.0|18.325|1297.101|||ANCOVA|||||1297.101|18.325|0.044
72484109|NCT02564926|144495099|OTHER||LS mean difference (mg/L)|-0.12||||0.756|TWO_SIDED|95.0|-0.858|0.625|||ANCOVA|||||0.625|-0.858|0.756
72484110|NCT02564926|144495100|OTHER||LS mean difference (%)|-1.94|||<|0.001|TWO_SIDED|95.0|-2.807|-1.082|||ANCOVA|||||-1.082|-2.807|<0.001
72484111|NCT01554488|144495110|OTHER||Mean Difference (Net)|-1.03|||||TWO_SIDED|95.0|-5.03|2.92||||||All of the comparisons were based on mixed effects linear regression models with visit and group\*visit as fixed effects and subject as a random effect. Confidence intervals for the treatment difference (group\*visit interaction) were constructed using the Wald method.||2.92|-5.03|
72484112|NCT02038920|144495128|SUPERIORITY||Odds Ratio (OR)|1.8||||0.1448|TWO_SIDED|95.0|0.816|3.958|||Cochran-Mantel-Haenszel||MLN0002 group/placebo group. Cochran-Mantel-Haenszel (CMH) test was used for analysis. Prior tumor necrosis factor alpha (TNFα) antagonist use (yes/no) was used as stratification factor.|||3.958|0.816|0.1448
72484113|NCT02038920|144495129|SUPERIORITY||Odds Ratio (OR)|3.57||||0.1779|TWO_SIDED|95.0|0.532|23.953|||Pearson's Chi-square Test||MLN0002 group/placebo group|||23.953|0.532|0.1779
72484114|NCT02038920|144495135|SUPERIORITY||Odds Ratio (OR)|1.83||||0.1963|TWO_SIDED|95.0|0.72|4.673|||Cochran-Mantel-Haenszel||MLN0002 group/placebo group. Cochran-Mantel-Haenszel (CMH) test was used for analysis. Prior tumor necrosis factor alpha (TNFα) antagonist use (yes/no) was used as stratification factor.|||4.673|0.720|0.1963
72484115|NCT02038920|144495137|SUPERIORITY||Odds Ratio (OR)|15.4||||0.0094|TWO_SIDED|95.0|1.473|160.972|||Pearson's Chi-square Test|||||160.972|1.473|0.0094
72484116|NCT02038920|144495138|SUPERIORITY||Odds Ratio (OR)|1.5||||0.6534|TWO_SIDED|95.0|0.254|8.844|||Pearson's Chi-square Test||MLN0002 group/placebo group.|||8.844|0.254|0.6534
72484117|NCT02038920|144495139|SUPERIORITY|||||||0.2059|||||||Pearson's Chi-square Test|||||||0.2059
72484118|NCT02383589|144495154|SUPERIORITY||Difference in proportion|30.8|||<|0.0001|TWO_SIDED|95.0|14.7|45.15||The analysis was stratified by the stratification factors applied at randomization.|Cochran-Mantel-Haenszel|||||45.15|14.70|<0.0001
72484119|NCT02383589|144495155|SUPERIORITY|||||||0.0005|||||||Wilcoxon (Mann-Whitney)|||||||0.0005
72512071|NCT02065622|144554203|SUPERIORITY||Adjusted risk difference|4.2||||0.44|TWO_SIDED|95.0|-6.4|14.8|||Cochran-Mantel-Haenszel||Risk difference = Adalimumab 40mg EW - Adalimumab 40mg EOW.|Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel (CMH) test adjusted for induction treatment regimen and week 8 remission status.||14.8|-6.4|0.440
72512072|NCT04973228|144554211|SUPERIORITY||Odds Ratio (OR)|2.79|||<|0.0001|TWO_SIDED|95.0|1.75|4.45|||Cochran-Mantel-Haenszel|Stratified by pooled site and IGA strata with multiple imputation to handle missing data|Stratified by pooled site and IGA strata with multiple imputation to handle missing data|IGA Success at Week 8||4.45|1.75|<0.0001
72512073|NCT04973228|144554212|SUPERIORITY||Odds Ratio (OR)|2.95||||0.0001|TWO_SIDED|95.0|1.68|5.19|||Cochran-Mantel-Haenszel|Stratified by pooled site and IGA strata with multiple imputation to handle missing data|Stratified by pooled site and IGA strata with multiple imputation to handle missing data|WI-NRS Success at Week 8||5.19|1.68|0.0001
72512074|NCT04973228|144554213|SUPERIORITY||Odds Ratio (OR)|2.62||||0.0007|TWO_SIDED|95.0|1.47|4.67|||Cochran-Mantel-Haenszel|Stratified by pooled site and IGA strata with multiple imputation to handle missing data|Stratified by pooled site and IGA strata with multiple imputation to handle missing data|WI-NRS Success at Week 4||4.67|1.47|0.0007
72512075|NCT04973228|144554214|SUPERIORITY||Odds Ratio (OR)|2.74||||0.0016|TWO_SIDED|95.0|1.41|5.34|||Cochran-Mantel-Haenszel|Stratified by pooled site and IGA strata with multiple imputation to handle missing data|Stratified by pooled site and IGA strata with multiple imputation to handle missing data|WI-NRS Success at Week 2||5.34|1.41|0.0016
72512076|NCT04973228|144554215|SUPERIORITY||Odds Ratio (OR)|2.43||||0.0002|TWO_SIDED|95.0|1.54|3.84|||Cochran-Mantel-Haenszel|Pooled by site and IGA strata with multiple imputation to handle missing data|Pooled by site and IGA strata with multiple imputation to handle missing data|IGA Success at Week 2||3.84|1.54|0.0002
72567318|NCT00518882|144665566|SUPERIORITY_OR_OTHER||Estimated treatment difference, LS Mean|-0.39||||0.143||95.0|-0.91|0.13||There were no multiplicity concerns.|ANCOVA|||ANCOVA model included treatment, country and previous treatment as fixed effects and baseline value of the endpoint as covariate. The objective was to demonstrate that treatment with liraglutide was different from treatment with exenatide. Thus the null hypothesis and its alternative were H0: µliraglutide = µexenatide against HA1:µliraglutide ≠ µexenatide where µliraglutide and µexenatide is the mean value of the endpoint in the liraglutide arm and exenatide arm, respectively.||0.13|-0.91|0.1430
72402390|NCT01480076|144311677|SUPERIORITY_OR_OTHER|||||||0.1398|||||||mixed effect model|||Overall, PRMS. Mixed effect model for repeated measures with visit, baseline MCS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.1398
72512077|NCT04973228|144554216|SUPERIORITY||Odds Ratio (OR)|3.22|||<|0.0001|TWO_SIDED|95.0|2.06|5.03|||Cochran-Mantel-Haenszel|Pooled by site and IGA strata with multiple imputation to handle missing data|Pooled by site and IGA strata with multiple imputation to handle missing data|IGA Success at Week 4||5.03|2.06|<0.0001
72512078|NCT04973228|144554217|SUPERIORITY||Odds Ratio (OR)|2.41|||<|0.0001|TWO_SIDED|95.0|1.56|3.73|||Cochran-Mantel-Haenszel|Stratified by pooled site and IGA strata with multiple imputation to handle missing data|Stratified by pooled site and IGA strata with multiple imputation to handle missing data|Scaling Score of 0 at Week 8||3.73|1.56|<0.0001
72512079|NCT04973228|144554218|SUPERIORITY||Odds Ratio (OR)|3.22|||<|0.0001|TWO_SIDED|95.0|2.05|5.06|||Cochran-Mantel-Haenszel|Stratified by pooled site and IGA strata with multiple imputation to handle missing data|Stratified by pooled site and IGA strata with multiple imputation to handle missing data|Erythema Score of 0 at Week 8||5.06|2.05|<0.0001
72512080|NCT04237207|144554219|NON_INFERIORITY|The primary efficacy objective is to demonstrate non-inferiority of AutoSense on the M90 processor compared to AutoSound on the Q90 processor for the AzBio sentence test in quiet mode based on a paired t-test. The primary efficacy analyses will test the null hypothesis (inferiority) that the mean of the paired differences in AzBio sentence scores in quiet mode (AutoSense on M90 - AutoSound on Q90) are less than or equal to -10 percentage points.||||||0.001|||||||t-test, 2 sided|||||||0.0010
72512081|NCT04237207|144554220|NON_INFERIORITY|The 1st secondary endpoint was to demonstrate that speech recognition in noise with AutoSense on a 301-M062 processor was no worse than speech recognition in noise with currently approved software on a Q90 processor.||||||0.001|||||||t-test, 2 sided|||||||0.0010
72512082|NCT04237207|144554221|NON_INFERIORITY|"The 2nd secondary endpoint was to demonstrate increased speech recognition in noise with the 301-M062 sound processor when comparing Omnidirectional program to AutoSense."|||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
72512083|NCT00755846|144554247|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.43|STANDARD_ERROR_OF_MEAN|0.135||0.001||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and body mass index (BMI), diabetes duration and baseline HbA1c as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HbA1c. With at least 234 patients, a two-group t-test with a 0.05 two-sided significance has at least 98% power to detect a treatment difference (all active versus placebo) in HbA1c change from baseline as small as 0.55%, assuming a common standard deviation of 0.7%.||||0.001
72512084|NCT00755846|144554247|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|0.171||0.004||95.0||||A step-down sequential approach was used to test the hypothesis that the treatment coefficient in the model is 0 for each of the five individual active treatment groups vs. placebo.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline HbA1c as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HbA1c. With at least 234 patients, a two-group t-test with a 0.05 two-sided significance level has 90% power to detect a treatment difference (each active dose versus placebo) in HbA1c change from baseline as small as 0.55%, assuming a common standard deviation of 0.7%.||||0.004
72512085|NCT00755846|144554247|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.42|STANDARD_ERROR_OF_MEAN|0.176||0.017||95.0||||A step-down sequential approach was used to test the hypothesis that the treatment coefficient in the model is 0 for each of the five individual active treatment groups vs. placebo.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline HbA1c as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HbA1c. With at least 234 patients, a two-group t-test with a 0.05 two-sided significance level has 90% power to detect a treatment difference (each active dose versus placebo) in HbA1c change from baseline as small as 0.55%, assuming a common standard deviation of 0.7%.||||0.017
72512086|NCT00755846|144554247|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.55|STANDARD_ERROR_OF_MEAN|0.17||0.001||95.0||||A step-down sequential approach was used to test the hypothesis that the treatment coefficient in the model is 0 for each of the five individual active treatment groups vs. placebo.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline HbA1c as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HbA1c. With at least 234 patients, a two-group t-test with a 0.05 two-sided significance level has 90% power to detect a treatment difference (each active dose versus placebo) in HbA1c change from baseline as small as 0.55%, assuming a common standard deviation of 0.7%.||||0.001
72512087|NCT00755846|144554247|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.52|STANDARD_ERROR_OF_MEAN|0.174||0.003||95.0||||A step-down sequential approach was used to test the hypothesis that the treatment coefficient in the model is 0 for each of the five individual active treatment groups vs. placebo.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline HbA1c as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HbA1c. With at least 234 patients, a two-group t-test with a 0.05 two-sided significance level has 90% power to detect a treatment difference (each active dose versus placebo) in HbA1c change from baseline as small as 0.55%, assuming a common standard deviation of 0.7%.||||0.003
72512088|NCT00755846|144554247|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.18|STANDARD_ERROR_OF_MEAN|0.173||0.307||95.0||||A step-down sequential approach was used to test the hypothesis that the treatment coefficient in the model is 0 for each of the five individual active treatment groups vs. placebo.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline HbA1c as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HbA1c. With at least 234 patients, a two-group t-test with a 0.05 two-sided significance level has 90% power to detect a treatment difference (each active dose versus placebo) in HbA1c change from baseline as small as 0.55%, assuming a common standard deviation of 0.7%.||||0.307
72484120|NCT02383589|144495156|SUPERIORITY||Adjusted Rate Ratio|0.12|||<|0.0001|TWO_SIDED|95.0|0.05|0.29||The model was adjusted for the following covariates in addition to log (each participant's duration in study) as an offset: treatment, region, duration of illness, baseline PDAI activity score, and baseline prednisone dose.|Negative Binominal Regression|||||0.29|0.05|<0.0001
72484121|NCT02383589|144495157|SUPERIORITY||Hazard Ratio (HR)|4.83||||0.0003|TWO_SIDED|95.0|1.97|11.81||P-value is from a stratified log-rank test used to test the time to first disease flare between the RTX and MMF treatment arms over the 52-week treatment period, adjusting for the stratification factors applied at randomization|Log Rank|||||11.81|1.97|0.0003
72512089|NCT00755846|144554248|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.31|STANDARD_ERROR_OF_MEAN|0.106||0.004||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline HbA1c as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HbA1c. With at least 234 patients, a two-group t-test with a 0.05 two-sided significance level has at least 98% power to detect a treatment difference (all active versus placebo) in HbA1c change from baseline as small as 0.55%, assuming a common standard deviation of 0.7%.||||0.004
72512090|NCT00755846|144554248|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.32|STANDARD_ERROR_OF_MEAN|0.134||0.017||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline HbA1c as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HbA1c. With at least 234 patients, a two-group t-test with a 0.05 two-sided significance level has 90% power to detect a treatment difference (each active dose versus placebo) in HbA1c change from baseline as small as 0.55%, assuming a common standard deviation of 0.7%.||||0.017
72512091|NCT00755846|144554248|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.34|STANDARD_ERROR_OF_MEAN|0.138||0.016||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline HbA1c as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HbA1c. With at least 234 patients, a two-group t-test with a 0.05 two-sided significance level has 90% power to detect a treatment difference (each active dose versus placebo) in HbA1c change from baseline as small as 0.55%, assuming a common standard deviation of 0.7%.||||0.016
72484122|NCT02383589|144495158|SUPERIORITY||Hazard Ratio (HR)|0.15|||<|0.0001|TWO_SIDED|95.0|0.06|0.39||P-value is from a stratified log-rank test used to test the time to first disease flare between the RTX and MMF treatment arms over the 52-week treatment period, adjusting for the stratification factors applied at randomization|Log Rank|||||0.39|0.06|<0.0001
72402391|NCT01480076|144311677|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 3, RRMS. Mixed effect model for repeated measures with visit, baseline MCS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
72402392|NCT01480076|144311677|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 3, SPMS. Mixed effect model for repeated measures with visit, baseline MCS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
72402393|NCT01480076|144311677|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 3, PPMS. Mixed effect model for repeated measures with visit, baseline MCS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
72402394|NCT01480076|144311677|SUPERIORITY_OR_OTHER|||||||0.0935|||||||mixed effect model|||Month 3, PRMS. Mixed effect model for repeated measures with visit, baseline MCS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.0935
72402395|NCT01480076|144311677|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 6, RRMS. Mixed effect model for repeated measures with visit, baseline MCS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
72484123|NCT02383589|144495159|SUPERIORITY||Difference in Estimated Means|-2.872||||0.0012|TWO_SIDED|95.0|-4.577|-1.167||P-value is from Mixed Model Repeated Measures (MMRM) with unstructured covariance matrix, adjusting for treatment, region, duration of illness, baseline DLQI score, visit, and an interaction terms for visit × baseline DLQI score and visit × treatment|Mixed Model Repeated Measures|||||-1.167|-4.577|0.0012
72484124|NCT00866697|144495163|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.766||||0.0021|TWO_SIDED|95.0|0.643|0.911||The P-value from the stratified log-rank test was adjusted for the two stratification factors.|Log Rank||The Hazard Ratio was estimated using a Pike estimator.|||0.911|0.643|0.0021
72484125|NCT00866697|144495164|SUPERIORITY||Hazard Ratio (HR)|0.96||||0.6431|TWO_SIDED|95.0|0.805|1.145|||Log Rank|Stratified Log-Rank P-Value.|"The HR was estimated using a Pike estimator.~CIs were estimated using the Brookmeyer-Crowley method."|||1.145|0.805|0.6431
72484126|NCT02673619|144495226|OTHER||Percentage difference|25.0|||||TWO_SIDED|90.0|-21.1|75.1||||||||75.1|-21.1|
72484127|NCT02673619|144495226|OTHER||Percentage difference|25.5|||||TWO_SIDED|90.0|-10.2|59.2||||||||59.2|-10.2|
72484128|NCT02673619|144495227|OTHER||Percentage Difference|-16.2|||||TWO_SIDED|90.0|-59.7|32.0||||||||32.0|-59.7|
72624076|NCT04983979|144778491|OTHER||Mean Difference (Final Values)|-0.66|||||TWO_SIDED|95.0|-1.97|0.65|||||Only the mean difference for the study end (week 12) is presented here|Due to the small sample size only an estimate of the difference between study arms was generated. No hypothesis tests were completed.||0.65|-1.97|
72402396|NCT01480076|144311677|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 6, SPMS. Mixed effect model for repeated measures with visit, baseline MCS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
72402397|NCT01480076|144311677|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 6, PPMS. Mixed effect model for repeated measures with visit, baseline MCS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
72402398|NCT01480076|144311677|SUPERIORITY_OR_OTHER|||||||0.076|||||||mixed effect model|||Month 6, PRMS. Mixed effect model for repeated measures with visit, baseline MCS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.0760
72402399|NCT01480076|144311677|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 9, RRMS. Mixed effect model for repeated measures with visit, baseline MCS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
72402400|NCT01480076|144311677|SUPERIORITY_OR_OTHER|||||||0.0019|||||||mixed effect model|||Month 9, SPMS. Mixed effect model for repeated measures with visit, baseline MCS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.0019
72484129|NCT02673619|144495227|OTHER||Percentage Difference|18.0|||||TWO_SIDED|90.0|-18.8|52.1||||||||52.1|-18.8|
72484130|NCT02673619|144495231|OTHER||Percentage Difference|16.2|||||TWO_SIDED|90.0|-32.0|59.7||||||||59.7|-32.0|
72484131|NCT02673619|144495231|OTHER||Percentage Difference|7.5|||||TWO_SIDED|90.0|-27.7|42.3||||||||42.3|-27.7|
72484132|NCT03660826|144495285|SUPERIORITY||Hazard Ratio (HR)|1.45||||0.93|TWO_SIDED|95.0|0.91|2.3||Comparing Arm II vs Arm I (reference group)|Log Rank||||Comparing Arm II vs Arm I (reference group)|2.30|0.91|0.93
72484133|NCT03660826|144495285|SUPERIORITY||Hazard Ratio (HR)|0.7||||0.06|TWO_SIDED|95.0|0.43|1.14|||Log Rank|||Comparing Arm III vs Arm I||1.14|0.43|0.06
72484134|NCT03660826|144495285|SUPERIORITY||Hazard Ratio (HR)|1.06||||0.62|TWO_SIDED|95.0|0.67|1.7|||Log Rank|||Comparing Arm IV vs Arm VII||1.70|0.67|0.62
72484135|NCT03660826|144495285|SUPERIORITY||Hazard Ratio (HR)|0.92||||0.36|TWO_SIDED|95.0|0.58|1.46|||Log Rank|||Comparing Arm V vs Arm VII||1.46|0.58|0.36
72484136|NCT03660826|144495285|SUPERIORITY||Hazard Ratio (HR)|0.78||||0.14|TWO_SIDED|95.0|0.49|1.25|||Log Rank|||Comparing Arm VI vs VII||1.25|0.49|0.14
72484137|NCT02464228|144495326|OTHER|||||||0|||||||Wilson approximation|||Null hypothesis H0: PORR = 10% versus HA: PORR \> 10% will be tested at a = 0.05 significance level using a two-sided binomial test. The choice of test statistics was driven by the method used for interval estimation.||||0.000
72512092|NCT00755846|144554248|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.38|STANDARD_ERROR_OF_MEAN|0.134||0.005||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline HbA1c as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HbA1c. With at least 234 patients, a two-group t-test with a 0.05 two-sided significance level has 90% power to detect a treatment difference (each active dose versus placebo) in HbA1c change from baseline as small as 0.55%, assuming a common standard deviation of 0.7%.||||0.005
72512093|NCT00755846|144554248|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.37|STANDARD_ERROR_OF_MEAN|0.137||0.008||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline HbA1c as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HbA1c. With at least 234 patients, a two-group t-test with a 0.05 two-sided significance level has 90% power to detect a treatment difference (each active dose versus placebo) in HbA1c change from baseline as small as 0.55%, assuming a common standard deviation of 0.7%.||||0.008
72512094|NCT00755846|144554248|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.14|STANDARD_ERROR_OF_MEAN|0.136||0.321||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline HbA1c as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HbA1c. With at least 234 patients, a two-group t-test with a 0.05 two-sided significance level has 90% power to detect a treatment difference (each active dose versus placebo) in HbA1c change from baseline as small as 0.55%, assuming a common standard deviation of 0.7%.||||0.321
72567319|NCT00518882|144665567|SUPERIORITY_OR_OTHER||Estimated treatment difference, LS Mean|0.54||||0.038||95.0|0.03|1.05||There were no multiplicity concerns.|ANCOVA|||ANCOVA model included treatment, country and previous treatment as fixed effects and baseline value of the endpoint as covariate. The objective was to demonstrate that treatment with liraglutide was different from treatment with exenatide. Thus the null hypothesis and its alternative were H0: µliraglutide = µexenatide against HA1:µliraglutide ≠ µexenatide where µliraglutide and µexenatide is the mean value of the endpoint in the liraglutide arm and exenatide arm, respectively.||1.05|0.03|0.0380
72567320|NCT00518882|144665568|SUPERIORITY_OR_OTHER||Mean|0.06|STANDARD_DEVIATION|2.827||0.77||95.0|-0.344|0.463|||Paired t test|||A paired t test was made within the group and 95% confidence intervals for the difference between Weeks 26 and 78 were constructed. H0 was µ78 - µ26 = 0 against HA: µ78 - µ26 ≠ 0. A difference between the two means (Week 26 and Week 78) was concluded when H0 was rejected at the 5% level.||0.463|-0.344|0.7700
72567321|NCT00518882|144665568|SUPERIORITY_OR_OTHER||Mean|0.72|STANDARD_DEVIATION|3.27||0.0042||95.0|0.23|1.212|||Paired t test|||The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 0 and 78 were constructed. H0 was µ78- µ0=0 against HA: µ78 - µ0 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.||1.212|0.230|0.0042
72567322|NCT00518882|144665569|SUPERIORITY_OR_OTHER||Mean|0.67|STANDARD_DEVIATION|3.041||0.0026||95.0|0.238|1.106|||Paired t test|||A paired t test was made within the group and 95% confidence intervals for the difference between Weeks 26 and 78 were constructed. H0 was µ78 - µ26 = 0 against HA: µ78 - µ26 ≠ 0. A difference between the two means (Week 26 and Week 78) was concluded when H0 was rejected at the 5% level.||1.106|0.238|0.0026
72567323|NCT00518882|144665569|SUPERIORITY_OR_OTHER||Mean|-0.09|STANDARD_DEVIATION|2.989||0.6845||95.0|-0.541|0.356|||Paired t test|||A paired t test was made within the treatment group and 95% confidence intervals for the difference between Weeks 26 and 78 were constructed. H0 was µ78 - µ26 = 0 against HA: µ78 - µ26 ≠ 0. A difference between the two means (Week 26 and Week 78) was concluded when H0 was rejected at the 5% level.||0.356|-0.541|0.6845
72567324|NCT00518882|144665570|SUPERIORITY_OR_OTHER||Mean|0.32|STANDARD_DEVIATION|2.705||0.1041||95.0|-0.066|0.706|||Paired t test|||A paired t test was made within the group and 95% confidence intervals for the difference between Weeks 26 and 78 were constructed. H0 was µ78 - µ26 = 0 against HA: µ78 - µ26 ≠ 0. A difference between the two means (Week 26 and Week 78) was concluded when H0 was rejected at the 5% level.||0.706|-0.066|0.1041
72484138|NCT02464228|144495326|OTHER|||||||1|||||||Wilson approximation|||Null hypothesis H0: PORR = 10% versus HA: PORR \> 10% will be tested at a = 0.05 significance level using a two-sided binomial test. The choice of test statistics was driven by the method used for interval estimation.||||1.000
72484139|NCT02464228|144495326|OTHER|||||||0.026|||||||Wilson approximation|||Null hypothesis H0: PORR = 10% versus HA: PORR \> 10% will be tested at a = 0.05 significance level using a two-sided binomial test. The choice of test statistics was driven by the method used for interval estimation.||||0.026
72484140|NCT02464228|144495326|OTHER|||||||1|||||||Clopper-Pearson method|||Null hypothesis H0: PORR = 10% versus HA: PORR \> 10% will be tested at a = 0.05 significance level using a two-sided binomial test. The choice of test statistics was driven by the method used for interval estimation.||||1.000
72484141|NCT01423812|144495436|OTHER||||||<|0.05|||||||t-test, 2 sided|||p value||||<0.05
72484142|NCT01423812|144495437|OTHER||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
72484143|NCT00998426|144495470|SUPERIORITY_OR_OTHER|||||||0.59|TWO_SIDED|||||This is the p value for the meter by time interaction|Random intercept model|||A random intercept model was used to fit the five subjects' glucose reading data over time. The fixed effect glucose meters, time effect and their interactions were included in the model.||||0.59
72484144|NCT02967354|144495471|SUPERIORITY|||||||0.5875||||||Treshold for significance P\<0.05|ANOVA|||||||0.5875
72484145|NCT02967354|144495472|SUPERIORITY|||||||0.0065||||||Treshold for significance P\<0.05|ANOVA|||||||0.0065
72484146|NCT02967354|144495473|SUPERIORITY|||||||0.0072||||||Treshold for significance P\<0.05|ANOVA|||||||0.0072
72484147|NCT02967354|144495474|SUPERIORITY|||||||0.9472||||||Treshold for significance P\<0.05|ANOVA|||||||0.9472
72484148|NCT02967354|144495475|SUPERIORITY|||||||0.0048||||||Treshold for significance P\<0.05|ANOVA|||||||0.0048
72402401|NCT01480076|144311677|SUPERIORITY_OR_OTHER|||||||0.0037|||||||mixed effect model|||Month 9, PPMS. Mixed effect model for repeated measures with visit, baseline MCS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.0037
72402402|NCT01480076|144311677|SUPERIORITY_OR_OTHER|||||||0.2489|||||||mixed effect model|||Month 9, PRMS. Mixed effect model for repeated measures with visit, baseline MCS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.2489
72402403|NCT01480076|144311677|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 12, RRMS. Mixed effect model for repeated measures with visit, baseline MCS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
72402404|NCT01480076|144311677|SUPERIORITY_OR_OTHER|||||||0.0001|||||||mixed effect model|||Month 12, SPMS. Mixed effect model for repeated measures with visit, baseline MCS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.0001
72484149|NCT01158651|144495476|SUPERIORITY|The treatment regimen was considered promising for further study if after 48 weeks of treatment there was at least a 25% response rate compared to an expected response rate of 5% or less, which was considered evidence of an unpromising regimen. Assuming the true response rate is 5%, the binomial distribution was used to calculate Type I errors and power.|Proportion responding|0.682|||<|0.001|TWO_SIDED|95.0|0.4872|0.8764|||Exact test|||||0.8764|0.4872|<0.001
72484150|NCT05696236|144495545|SUPERIORITY|||||||0.77|||||||t-test, 2 sided|||||||0.77
72484151|NCT05696236|144495546|SUPERIORITY|||||||0.07|||||||t-test, 2 sided|||||||0.07
72484152|NCT05696236|144495547|SUPERIORITY|||||||0.006|||||||t-test, 2 sided|||||||0.006
72484153|NCT05341700|144495549|SUPERIORITY|||||||0.246|||||||Mixed Models Analysis|||Null hypothesis is that there was no difference in change of PINP between RUN and RUN+J.||||0.246
72484154|NCT05341700|144495550|SUPERIORITY|||||||0.714|||||||Mixed Models Analysis|||Null hypothesis is that there was no difference in change of CTX between RUN and RUN+J.||||0.714
72484155|NCT05341700|144495551|SUPERIORITY|||||||0.309|||||||Mixed Models Analysis|||||||0.309
72484156|NCT05341700|144495552|SUPERIORITY|||||||0.308|||||||Mixed Models Analysis|||Null hypothesis is that there was no difference in change of IGF1 between RUN and RUN+J.||||0.308
72484157|NCT05341700|144495553|SUPERIORITY|||||||0.207|||||||Mixed Models Analysis|||Null hypothesis is that there was no difference in change of ferritin between RUN and RUN+J.||||0.207
72567325|NCT00518882|144665570|SUPERIORITY_OR_OTHER||Mean|0.58|STANDARD_DEVIATION|3.114||0.0151||95.0|0.114|1.052|||Paired t test|||A paired t test was made within the treatment group and 95% confidence intervals for the difference between Weeks 26 and 78 were constructed. H0 was µ78 - µ26 = 0 against HA: µ78 - µ26 ≠ 0. A difference between the two means (Week 26 and Week 78) was concluded when H0 was rejected at the 5% level.||1.052|0.114|0.0151
72402405|NCT01480076|144311677|SUPERIORITY_OR_OTHER|||||||0.0052|||||||mixed effect model|||Month 12, PPMS. Mixed effect model for repeated measures with visit, baseline MCS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.0052
72402406|NCT01480076|144311677|SUPERIORITY_OR_OTHER|||||||0.7714|||||||mixed effect model|||Month 12, PRMS. Mixed effect model for repeated measures with visit, baseline MCS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.7714
72402407|NCT01480076|144311678|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Overall, RRMS. Mixed effect model for repeated measures with visit, baseline MSIS-29 physical score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
72484158|NCT02378220|144495563|OTHER||Risk Ratio (RR)|0.65||||0.21|TWO_SIDED|95.0|0.32|1.28||P-value for 30 days measure.|Regression, Poisson|||||1.28|0.32|0.21
72484159|NCT02378220|144495563|OTHER||Risk Ratio (RR)|0.48||||0.007|TWO_SIDED|95.0|0.27|0.82||P-Value for 60 days measure|Regression, Poisson|||||0.82|0.27|0.007
72484160|NCT02378220|144495564|OTHER||Risk Ratio (RR)|0.62||||0.16|TWO_SIDED|95.0|0.31|1.21||P-Value for 30 days measure|Regression, Poisson|||||1.21|0.31|0.16
72484161|NCT02378220|144495564|OTHER||Risk Ratio (RR)|0.58||||0.045|TWO_SIDED|95.0|0.34|0.99|||Regression, Poisson|||||0.99|0.34|0.045
72484162|NCT02378220|144495565|OTHER||Hazard Ratio (HR)|0.59||||0.1|TWO_SIDED|95.0|0.31|1.12|||Log Rank|||||1.12|0.31|0.10
72484163|NCT02378220|144495566|OTHER||Hazard Ratio (HR)|0.6||||0.09|TWO_SIDED|95.0|0.33|1.1|||Log Rank|||||1.10|0.33|0.09
72484164|NCT00578786|144495579|SUPERIORITY_OR_OTHER||Mean Difference (Net)|38.0|STANDARD_DEVIATION|74.28|||TWO_SIDED|95.0|22.7|53.3|||||Applies to Ambrisentan 2.5 mg group only. Missing values were imputed using last-observation-carried forward method (LOCF) based on post-baseline observations.|||53.3|22.7|
72484165|NCT00578786|144495579|SUPERIORITY_OR_OTHER||Mean Difference (Net)|32.5|STANDARD_DEVIATION|78.55|||TWO_SIDED|95.0|21.1|43.8|||||Applies to Ambrisentan 5 mg group only. Missing values were imputed using last-observation-carried forward method (LOCF) based on post-baseline observations.|||43.8|21.1|
72484166|NCT00578786|144495579|SUPERIORITY_OR_OTHER||Mean Difference (Net)|40.9|STANDARD_DEVIATION|72.85|||TWO_SIDED|95.0|26.1|55.7|||||Applies to Ambrisentan 10 mg group only. LOCF method of imputation. Missing values were imputed using last-observation-carried forward method (LOCF) based on post-baseline observations.|||55.7|26.1|
72484167|NCT00578786|144495579|SUPERIORITY_OR_OTHER||Mean Difference (Net)|36.0|STANDARD_DEVIATION|75.97|||TWO_SIDED|95.0|28.3|43.7|||||Applies to Ambrisentan combined group only. LOCF method of imputation.|||43.7|28.3|
72484168|NCT00578786|144495580|SUPERIORITY_OR_OTHER||Mean Difference (Net)|24.9|STANDARD_DEVIATION|96.14|||TWO_SIDED|95.0|5.1|44.7|||||Applies to Ambrisentan 2.5 mg group only. Missing values were imputed using last-observation-carried forward method (LOCF) based on post-baseline observations.|||44.7|5.1|
72402408|NCT01480076|144311678|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Overall, SPMS. Mixed effect model for repeated measures with visit, baseline MSIS-29 physical score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
72402409|NCT01480076|144311678|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Overall, PPMS. Mixed effect model for repeated measures with visit, baseline MSIS-29 physical score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
72402410|NCT01480076|144311678|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Overall, PRMS. Mixed effect model for repeated measures with visit, baseline MSIS-29 physical score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
72402411|NCT01480076|144311678|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 3, RRMS. Mixed effect model for repeated measures with visit, baseline MSIS-29 physical score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
72402412|NCT01480076|144311678|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 3, SPMS. Mixed effect model for repeated measures with visit, baseline MSIS-29 physical score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
72402413|NCT01480076|144311678|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 3, PPMS. Mixed effect model for repeated measures with visit, baseline MSIS-29 physical score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
72402414|NCT01480076|144311678|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 3, PRMS. Mixed effect model for repeated measures with visit, baseline MSIS-29 physical score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
72484169|NCT00578786|144495580|SUPERIORITY_OR_OTHER||Mean Difference (Net)|27.9|STANDARD_DEVIATION|94.5|||TWO_SIDED|95.0|14.2|41.6|||||Applies to Ambrisentan 5.0 mg group only. Missing values were imputed using last-observation-carried forward method (LOCF) based on post-baseline observations.|||41.6|14.2|
72484170|NCT00578786|144495580|SUPERIORITY_OR_OTHER||Mean Difference (Net)|37.2|STANDARD_DEVIATION|72.97|||TWO_SIDED|95.0|22.4|52.0|||||Applies to Ambrisentan 10 mg group only. Missing values were imputed using last-observation-carried forward method (LOCF) based on post-baseline observations.|||52.0|22.4|
72567326|NCT00518882|144665571|SUPERIORITY_OR_OTHER||Mean|-3.31|STANDARD_DEVIATION|3.857|<|0.0001||95.0|-3.861|-2.763|||Paired t test|||The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 0 and 78 were constructed. H0 was µ78- µ0=0 against HA: µ78 - µ0 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.||-2.763|-3.861|<0.0001
72567327|NCT00518882|144665571|SUPERIORITY_OR_OTHER||Mean|-3.13|STANDARD_DEVIATION|3.56|<|0.0001||95.0|-3.673|-2.589|||Paired t test|||The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 0 and 78 were constructed. H0 was µ78- µ0=0 against HA: µ78 - µ0 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.||-2.589|-3.673|<0.0001
72624077|NCT04983979|144778492|OTHER||Mean Difference (Final Values)|25.15|||||TWO_SIDED|95.0|-48.83|99.13|||||Difference in change in systolic blood pressure between study arms.|Due to the small sample size only an estimate of the difference between study arms was generated. No hypothesis tests were completed.||99.13|-48.83|
72624078|NCT04983979|144778492|OTHER||Mean Difference (Final Values)|8.78|||||TWO_SIDED|95.0|-22.92|40.47|||||Difference in change in diastolic blood pressure between study arms.|Due to the small sample size only an estimate of the difference between study arms was generated. No hypothesis tests were completed.||40.47|-22.92|
72402415|NCT01480076|144311678|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 6, RRMS. Mixed effect model for repeated measures with visit, baseline MSIS-29 physical score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
72402416|NCT01480076|144311678|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 6, SPMS. Mixed effect model for repeated measures with visit, baseline MSIS-29 physical score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
72402417|NCT01480076|144311678|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 6, PPMS. Mixed effect model for repeated measures with visit, baseline MSIS-29 physical score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
72402418|NCT01480076|144311678|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 6, PRMS. Mixed effect model for repeated measures with visit, baseline MSIS-29 physical score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
72484171|NCT00578786|144495580|SUPERIORITY_OR_OTHER||Median Difference (Net)|29.5|STANDARD_DEVIATION|89.81|||TWO_SIDED|95.0|20.4|38.7|||||Applies to Ambrisentan combined group only. LOCF method of imputation.|||38.7|20.4|
72484172|NCT00578786|144495581|SUPERIORITY_OR_OTHER||Mean Difference (Net)|6.7|STANDARD_DEVIATION|97.48|||TWO_SIDED|95.0|-13.4|26.8|||||Applies to Ambrisentan 2.5 mg group only. LOCF method of imputation.|||26.8|-13.4|
72402419|NCT01480076|144311678|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 9, RRMS. Mixed effect model for repeated measures with visit, baseline MSIS-29 physical score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
72402420|NCT01480076|144311678|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 9, SPMS. Mixed effect model for repeated measures with visit, baseline MSIS-29 physical score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
72484173|NCT00578786|144495581|SUPERIORITY_OR_OTHER||Mean Difference (Net)|23.2|STANDARD_DEVIATION|100.69|||TWO_SIDED|95.0|8.7|37.8|||||Applies to Ambrisentan 5 mg group only. LOCF method of imputation.|||37.8|8.7|
72484174|NCT00578786|144495581|SUPERIORITY_OR_OTHER||Mean Difference (Net)|28.0|STANDARD_DEVIATION|84.38|||TWO_SIDED|95.0|10.9|45.1|||||Applies to Ambrisentan 10 mg group only. LOCF method of imputation.|||45.1|10.9|
72484175|NCT00578786|144495581|SUPERIORITY_OR_OTHER||Median Difference (Net)|20.3|STANDARD_DEVIATION|96.05|||TWO_SIDED|95.0|10.6|30.1|||||Applies to Ambrisentan combined group only. Missing values were imputed using last-observation-carried forward method (LOCF) based on post-baseline observations.|||30.1|10.6|
72484176|NCT00578786|144495582|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.7|STANDARD_DEVIATION|95.21|||TWO_SIDED|95.0|-18.9|20.3|||||Applies to Ambrisentan 2.5 mg group only. Missing values were imputed using last-observation-carried forward method (LOCF) based on post-baseline observations.|||20.3|-18.9|
72484177|NCT00578786|144495582|SUPERIORITY_OR_OTHER||Mean Difference (Net)|18.8|STANDARD_DEVIATION|101.22|||TWO_SIDED|95.0|4.2|33.5|||||Applies to Ambrisentan 5 mg group only. Missing values were imputed using last-observation-carried forward method (LOCF) based on post-baseline observations.|||33.5|4.2|
72484178|NCT00578786|144495582|SUPERIORITY_OR_OTHER||Mean Difference (Net)|27.8|STANDARD_DEVIATION|87.07|||TWO_SIDED|95.0|10.1|45.4|||||Applies to Ambrisentan 10 mg group only. Missing values were imputed using last-observation-carried forward method (LOCF) based on post-baseline observations.|||45.4|10.1|
72567328|NCT00518882|144665572|SUPERIORITY_OR_OTHER||Mean|-1.93|STANDARD_DEVIATION|3.703|<|0.0001||95.0|-2.457|-1.403|||Paired t test|||The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 0 and 78 were constructed. H0 was µ78- µ0=0 against HA: µ78 - µ0 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.||-1.403|-2.457|<0.0001
72567329|NCT00518882|144665572|SUPERIORITY_OR_OTHER||Mean|-2.17|STANDARD_DEVIATION|3.654|<|0.0001||95.0|-2.731|-1.618|||Paired t test|||The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 0 and 78 were constructed. H0 was µ78- µ0=0 against HA: µ78 - µ0 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.||-1.618|-2.731|<0.0001
72567330|NCT00518882|144665573|SUPERIORITY_OR_OTHER||Mean|-2.21|STANDARD_DEVIATION|3.752|<|0.0001||95.0|-2.747|-1.676|||Paired t test|||The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 0 and 78 were constructed. H0 was µ78- µ0=0 against HA: µ78 - µ0 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.||-1.676|-2.747|<0.0001
72567331|NCT00518882|144665573|SUPERIORITY_OR_OTHER||Mean|-2.55|STANDARD_DEVIATION|3.625|<|0.0001||95.0|-3.104|-1.997|||Paired t test|||The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 0 and 78 were constructed. H0 was µ78- µ0=0 against HA: µ78 - µ0 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.||-1.997|-3.104|<0.0001
72567332|NCT00518882|144665574|SUPERIORITY_OR_OTHER||Estimated treatment difference, LS Mean|29.37|||<|0.0001||95.0|16.81|41.93||There were no multiplicity concerns.|ANCOVA|||ANCOVA model included treatment, country and previous treatment as fixed effects and baseline value of the endpoint as covariate. The objective was to demonstrate that treatment with liraglutide was different from treatment with exenatide. Thus the null hypothesis and its alternative were H0: µliraglutide = µexenatide against HA1:µliraglutide ≠ µexenatide where µliraglutide and µexenatide is the mean value of the endpoint in the liraglutide arm and exenatide arm, respectively.||41.93|16.81|<.0001
72567333|NCT00518882|144665575|SUPERIORITY_OR_OTHER||Mean|-18.18|STANDARD_DEVIATION|62.811|<|0.0001||95.0|-26.988|-9.382|||Paired t test|||A paired t test was made within the group and 95% confidence intervals for the difference between Weeks 26 and 78 were constructed. H0 was µ78 - µ26 = 0 against HA: µ78 - µ26 ≠ 0. A difference between the two means (Week 26 and Week 78) was concluded when H0 was rejected at the 5% level.||-9.382|-26.988|<0.0001
72624079|NCT04983979|144778493|OTHER||Risk Difference (RD)|0.25|||||TWO_SIDED|95.0|-0.174|0.674||||||Due to the small sample size only an estimate of the difference between study arms was generated. No hypothesis tests were completed.||0.674|-0.174|
72624080|NCT04983979|144778494|OTHER||Risk Difference (RD)|0.0|||||TWO_SIDED|95.0|0.0|0.0||||||Due to the small sample size only an estimate of the difference between study arms was generated. No hypothesis tests were completed.||0.00|0.00|
72484179|NCT00578786|144495582|SUPERIORITY_OR_OTHER||Mean Difference (Net)|16.6|STANDARD_DEVIATION|96.54|||TWO_SIDED|95.0|6.8|26.4|||||Applies to Ambrisentan combined group only. Missing values were imputed using last-observation-carried forward method (LOCF) based on post-baseline observations.|||26.4|6.8|
72484180|NCT00578786|144495584|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.08|STANDARD_DEVIATION|2.254|||TWO_SIDED|95.0|-0.55|0.38|||||Applies to Ambrisentan 2.5 mg group only. Missing values were imputed using last-observation-carried forward method (LOCF) based on post-baseline observations.|||0.38|-0.55|
72484181|NCT00578786|144495584|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.59|STANDARD_DEVIATION|2.45|||TWO_SIDED|95.0|-0.94|-0.23|||||Applies to Ambrisentan 5 mg group only. Missing values were imputed using last-observation-carried forward method (LOCF) based on post-baseline observations.|||-0.23|-0.94|
72484182|NCT00578786|144495584|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.51|STANDARD_DEVIATION|2.4|||TWO_SIDED|95.0|-1.0|-0.03|||||Applies to Ambrisentan 10 mg group only. Missing values were imputed using last-observation-carried forward method (LOCF) based on post-baseline observations.|||-0.03|-1.00|
72484183|NCT00578786|144495584|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.44|STANDARD_DEVIATION|2.393|||TWO_SIDED|95.0|-0.69|-0.2|||||Applies to Ambrisentan combined group only. Missing values were imputed using last-observation-carried forward method (LOCF) based on post-baseline observations.|||-0.20|-0.69|
72484184|NCT00578786|144495585|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.23|STANDARD_DEVIATION|2.603|||TWO_SIDED|95.0|-0.31|0.76|||||Applies to Ambrisentan 2.5 mg group only. Missing values were imputed using last-observation-carried forward method (LOCF) based on post-baseline observations.|||0.76|-0.31|
72484185|NCT00578786|144495585|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.33|STANDARD_DEVIATION|2.477|||TWO_SIDED|95.0|-0.68|0.03|||||Applies to Ambrisentan 5 mg group only. Missing values were imputed using last-observation-carried forward method (LOCF) based on post-baseline observations.|||0.03|-0.68|
72484186|NCT00578786|144495585|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.65|STANDARD_DEVIATION|2.305|||TWO_SIDED|95.0|-1.12|-0.18|||||Applies to Ambrisentan 10 mg group only. Missing values were imputed using last-observation-carried forward method (LOCF) based on post-baseline observations.|||-0.18|-1.12|
72484187|NCT00578786|144495585|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.27|STANDARD_DEVIATION|2.48|||TWO_SIDED|95.0|-0.52|-0.02|||||Applies to Ambrisentan combined group only. Missing values were imputed using last-observation-carried forward method (LOCF) based on post-baseline observations.|||-0.02|-0.52|
72484188|NCT00578786|144495586|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.2|STANDARD_DEVIATION|2.593|||TWO_SIDED|95.0|-0.33|0.74|||||Applies to Ambrisentan 2.5 mg group only. Missing values were imputed using last-observation-carried forward method (LOCF) based on post-baseline observations.|||0.74|-0.33|
72484189|NCT00578786|144495586|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.14|STANDARD_DEVIATION|2.514|||TWO_SIDED|95.0|-0.51|0.22|||||Applies to Ambrisentan 5 mg group only. Missing values were imputed using last-observation-carried forward method (LOCF) based on post-baseline observations.|||0.22|-0.51|
72484190|NCT00578786|144495586|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.48|STANDARD_DEVIATION|2.215|||TWO_SIDED|95.0|-0.93|-0.03|||||Applies to Ambrisentan 10 mg group only. Missing values were imputed using last-observation-carried forward method (LOCF) based on post-baseline observations.|||-0.03|-0.93|
72484191|NCT00578786|144495586|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.14|STANDARD_DEVIATION|2.467|||TWO_SIDED|95.0|-0.39|0.11|||||Applies to Ambrisentan combined group only. Missing values were imputed using last-observation-carried forward method (LOCF) based on post-baseline observations.|||0.11|-0.39|
72542469|NCT00106028|144614688|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.534||||0.027||95.0|0.41|6.658|||ANCOVA|LS means and p-value are from ANCOVA model adjusted by baseline and fixed effects for age group, treatment and pooled center for post-baseline.||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.||6.658|0.410|0.0270
72567334|NCT00518882|144665575|SUPERIORITY_OR_OTHER||Mean|2.49|STANDARD_DEVIATION|52.997||0.5304||95.0|-5.327|10.307|||Paired t test|||A paired t test was made within the treatment group and 95% confidence intervals for the difference between Weeks 26 and 78 were constructed. H0 was µ78 - µ26 = 0 against HA: µ78 - µ26 ≠ 0. A difference between the two means (Week 26 and Week 78) was concluded when H0 was rejected at the 5% level.||10.307|-5.327|0.5304
72484192|NCT00312221|144495599|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.38||||0.126|TWO_SIDED|95.0|-0.8562|0.1054|||Mixed Models Analysis||Treatment comparison between BTDS 20 and BTDS 5 during the 12-week double-blind phase|||0.1054|-0.8562|0.126
72484193|NCT00312221|144495599|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.36||||0.14||95.0|-0.8455|0.1189|||Mixed Models Analysis||Treatment comparison between BTDS 5 and oxycodone immediate-release during the 12-week double-blind phase.|||0.1189|-0.8455|0.140
72484194|NCT00312221|144495600|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8||||0.007|TWO_SIDED|95.0|-1.47|-0.2|||ANCOVA||Treatment comparison between BTDS 5 and BTDS 20 during the 12-week double-blind phase.|||-0.20|-1.47|0.007
72484195|NCT00312221|144495600|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8||||0.011|TWO_SIDED|95.0|-1.47|-0.17|||ANCOVA||Treatment comparison between BTDS 5 and oxycodone immediate-release during the 12-week double-blind phase.|||-0.17|-1.47|0.011
72484196|NCT00312221|144495601|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.48||||0.707|TWO_SIDED|95.0|-3.0054|2.0397|||Mixed Models Analysis||Treatment comparison between BTDS 5 and BTDS 20 during the 12-week double-blind phase.|||2.0397|-3.0054|0.707
72484197|NCT00312221|144495601|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.79||||0.187|TWO_SIDED|95.0|-4.4459|0.8706|||Mixed Models Analysis||Treatment comparison between BTDS 5 and oxycodone immediate-release during the 12-week double-blind phase.|||0.8706|-4.4459|0.187
72484198|NCT00312221|144495602|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.96||||0.685|TWO_SIDED|95.0|-5.6177|3.693|||Mixed Models Analysis||Treatment comparison between BTDS 5 and BTDS 20 during the 12-week double-blind phase.|||3.6930|-5.6177|0.685
72484199|NCT00312221|144495602|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.81||||0.443|TWO_SIDED|95.0|-6.4415|2.8255|||Mixed Models Analysis||Treatment comparison between BTDS 5 and oxycodone immediate-release during the 12-week double-blind phase.|||2.8255|-6.4415|0.443
72484200|NCT05105789|144495621|SUPERIORITY|"One-sample binomial test. Null hypothesis: NPV of BinaxNOW at Home testing is at most 91%.~Alternative hypothesis: NPV of BinaxNOW at Home testing is greater than 91%."|Kappa Co-efficient|100.0||||0.0015|TWO_SIDED|95.0|95.0|100.0|||one-sample binomial test||binary outcome|Negative Predictive Value||100|95|0.0015
72567335|NCT00518882|144665576|SUPERIORITY_OR_OTHER||Mean|24.86|STANDARD_DEVIATION|59.326|<|0.0001||95.0|16.348|33.374|||Paired t test|||The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 0 and 78 were constructed. H0 was µ78- µ0=0 against HA: µ78 - µ0 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.||33.374|16.348|<0.0001
72567336|NCT00518882|144665576|SUPERIORITY_OR_OTHER||Mean|11.13|STANDARD_DEVIATION|87.145||0.092||95.0|-1.835|24.093|||Paired t test|||The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 0 and 78 were constructed. H0 was µ78- µ0=0 against HA: µ78 - µ0 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.||24.093|-1.835|0.0920
72567337|NCT00518882|144665577|SUPERIORITY_OR_OTHER||Estimated treatment difference, LS Mean|-0.11||||0.0946||95.0|-0.23|0.02||There were no multiplicity concerns.|ANCOVA|||ANCOVA model included treatment, country and previous treatment as fixed effects and baseline value of the endpoint as covariate. The objective was to demonstrate that treatment with liraglutide was different from treatment with exenatide. Thus the null hypothesis and its alternative were H0: µliraglutide = µexenatide against HA1:µliraglutide ≠ µexenatide where µliraglutide and µexenatide is the mean value of the endpoint in the liraglutide arm and exenatide arm, respectively.||0.02|-0.23|0.0946
72567338|NCT00518882|144665578|SUPERIORITY_OR_OTHER||Mean|0.11|STANDARD_DEVIATION|0.774||0.0513||95.0|-0.001|0.216|||Paired t test|||A paired t test was made within the group and 95% confidence intervals for the difference between Weeks 26 and 78 were constructed. H0 was µ78 - µ26 = 0 against HA: µ78 - µ26 ≠ 0. A difference between the two means (Week 26 and Week 78) was concluded when H0 was rejected at the 5% level.||0.216|-0.001|0.0513
72567339|NCT00518882|144665578|SUPERIORITY_OR_OTHER||Mean|0.12|STANDARD_DEVIATION|0.804||0.0513||95.0|-0.001|0.233|||Paired t test|||A paired t test was made within the group and 95% confidence intervals for the difference between Weeks 26 and 78 were constructed. H0 was µ78 - µ26 = 0 against HA: µ78 - µ26 ≠ 0. A difference between the two means (Week 26 and Week 78) was concluded when H0 was rejected at the 5% level.||0.233|-0.001|0.0513
72567340|NCT00518882|144665579|SUPERIORITY_OR_OTHER||Mean|-0.07|STANDARD_DEVIATION|0.859||0.2764||95.0|-0.187|0.054|||Paired t test|||The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 0 and 78 were constructed. H0 was µ78- µ0=0 against HA: µ78 - µ0 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.||0.054|-0.187|0.2764
72567341|NCT00518882|144665579|SUPERIORITY_OR_OTHER||Mean|0.09|STANDARD_DEVIATION|0.89||0.1911||95.0|-0.043|0.216|||Paired t test|||The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 0 and 78 were constructed. H0 was µ78- µ0=0 against HA: µ78 - µ0 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.||0.216|-0.043|0.1911
72484201|NCT05105789|144495621|NON_INFERIORITY|non-inferiority margin of δ=5% and a sensitivity/specificity of PCR of 99%||||||0.3308|||||||one-sample binomial test|||Sensitivity H0: Sens-0.99 ≤ 0.05 vs. HA: Sens-0.99 \> -0.05||||0.3308
72484202|NCT05105789|144495621|NON_INFERIORITY|a non-inferiority margin of δ=5% and a sensitivity/specificity of PCR of 99%||||||0.0536|||||||one-sample binomial test|||Specificity H0: Spec-0.99 ≤ 0.05 vs. HA: Spec-0.99 \> -0.05||||0.0536
72484203|NCT05105789|144495622|EQUIVALENCE|Concordance between the PCR test results will be evaluated by calculating the Kappa statistic which will be reported along with corresponding two-sided 95% confidence interval. The nonparametric bootstrap technique will be used to construct the confidence interval. A kappa statistic of \>0.95 will be considered as sufficient to define lollipop swab test non-inferior to the gold-standard PCR testing of nasal swabs.|Kappa Co-efficient|0.91|||||TWO_SIDED|95.0|0.78|1.0||||||Kappa statistics for Nasal Swab PCR vs Lollipop Swab PCR||1.00|0.78|
72484204|NCT05105789|144495623|NON_INFERIORITY|a non-inferiority margin of δ=5% and a sensitivity/specificity of PCR testing of 99%||||||0.201|||||||one-sample binomial test|||Sensitivity H0: Sens-0.99 ≤ 0.05 vs. HA: Sens-0.99 \> -0.05||||0.2010
72484205|NCT05105789|144495623|NON_INFERIORITY|non-inferiority margin of δ=5% and a sensitivity/specificity of PCR testing of 99%||||||0.0705|||||||one-sample binomial test|||Specificity H0: Spec-0.99 ≤ 0.05 vs. HA: Spec-0.99 \> -0.05||||0.0705
72576867|NCT00261443|144680664|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.3||||0.091|TWO_SIDED|95.0|-0.65|0.05||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 40 Comparison||0.05|-0.65|0.091
72576868|NCT00261443|144680664|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.29||||0.105|TWO_SIDED|95.0|-0.64|0.06||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 44 Comparison||0.06|-0.64|0.105
72576869|NCT00261443|144680664|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.36||||0.047|TWO_SIDED|95.0|-0.72|-0.01||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 48 Comparison||-0.01|-0.72|0.047
72624081|NCT04983979|144778495|OTHER||Risk Difference (RD)|0.25|||||TWO_SIDED|95.0|-0.174|0.674||||||Due to the small sample size only an estimate of the difference between study arms was generated. No hypothesis tests were completed.||0.674|-0.174|
72512095|NCT00755846|144554249|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-22.2|STANDARD_ERROR_OF_MEAN|6.65|<|0.001||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and body mass index (BMI), diabetes duration, and baseline FPG as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in fasting plasma glucose (FPG). The treatment effect was evaluated as a contrast of all doses of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||<0.001
72484206|NCT00323297|144495630|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.38|STANDARD_ERROR_OF_MEAN|11.722||0.5802|TWO_SIDED|90.0|-21.843|17.087||A sequential closed-testing procedure was implemented for all secondary endpoints. If no statistically significant treatment effect was found for the primary endpoint then statistical tests were not to be performed on the secondary endpoints.|ANCOVA|The mean difference in method of estimation is the difference between Sildenafil - placebo.||"The estimated sample size was based upon the primary endpoint. A sample size of 51 subjects per treatment group was required to detect a difference of 30 meters between treatments with 80% power at a one-sided significance level of 0.05, assuming a standard deviation of 60 meters.~This primary statistical analysis was carried for Week 12 data."||17.087|-21.843|0.5802
72484207|NCT01006265|144495658|SUPERIORITY||Treatment effect (rate ratio)|0.226|||<|0.0001|TWO_SIDED|95.0|0.133|0.384|||Negative binomial regression model|||||0.384|0.133|<0.0001
72484208|NCT01006265|144495658|SUPERIORITY||Treatment effect (rate ratio)|0.17|||<|0.0001|TWO_SIDED|95.0|0.1|0.289|||Negative binomial regression model|||||0.289|0.100|<0.0001
72484209|NCT01006265|144495658|SUPERIORITY||Treatment effect (rate ratio)|0.566||||0.0318|TWO_SIDED|95.0|0.337|0.952|||Negative binomial regression model|||||0.952|0.337|0.0318
72567342|NCT00518882|144665580|SUPERIORITY_OR_OTHER||Estimated treatment difference, LS Mean|-0.04||||0.4412||95.0|-0.15|0.06||There were no multiplicity concerns.|ANCOVA|||ANCOVA model included treatment, country and previous treatment as fixed effects and baseline value of the endpoint as covariate. The objective was to demonstrate that treatment with liraglutide was different from treatment with exenatide. Thus the null hypothesis and its alternative were H0: µliraglutide = µexenatide against HA1:µliraglutide ≠ µexenatide where µliraglutide and µexenatide is the mean value of the endpoint in the liraglutide arm and exenatide arm, respectively.||0.06|-0.15|0.4412
72567343|NCT00518882|144665581|SUPERIORITY_OR_OTHER||Mean|0.03|STANDARD_DEVIATION|0.606||0.4746||95.0|-0.054|0.115|||Paired t test|||A paired t test was made within the group and 95% confidence intervals for the difference between Weeks 26 and 78 were constructed. H0 was µ78 - µ26 = 0 against HA: µ78 - µ26 ≠ 0. A difference between the two means (Week 26 and Week 78) was concluded when H0 was rejected at the 5% level.||0.115|-0.054|0.4746
72567344|NCT00518882|144665581|SUPERIORITY_OR_OTHER||Mean|0.08|STANDARD_DEVIATION|0.72||0.1281||95.0|-0.024|0.188|||Paired t test|||A paired t test was made within the treatment group and 95% confidence intervals for the difference between Weeks 26 and 78 were constructed. H0 was µ78 - µ26 = 0 against HA: µ78 - µ26 ≠ 0. A difference between the two means (Week 26 and Week 78) was concluded when H0 was rejected at the 5% level.||0.188|-0.024|0.1281
72567345|NCT00518882|144665582|SUPERIORITY_OR_OTHER||Mean|-0.3|STANDARD_DEVIATION|0.604|<|0.0001||95.0|-0.39|-0.214|||Paired t test|||The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 0 and 78 were constructed. H0 was µ78- µ0=0 against HA: µ78 - µ0 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.||-0.214|-0.390|<0.0001
72567346|NCT00518882|144665582|SUPERIORITY_OR_OTHER||Mean|-0.21|STANDARD_DEVIATION|0.647|<|0.0001||95.0|-0.303|-0.11|||Paired t test|||The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 0 and 78 were constructed. H0 was µ78- µ0=0 against HA: µ78 - µ0 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.||-0.110|-0.303|<0.0001
72567347|NCT00518882|144665583|SUPERIORITY_OR_OTHER||Estimated treatment difference, LS Mean|-0.07||||0.0277||95.0|-0.13|-0.01||There were no multiplicity concerns.|ANCOVA|||ANCOVA model included treatment, country and previous treatment as fixed effects and baseline value of the endpoint as covariate. The objective was to demonstrate that treatment with liraglutide was different from treatment with exenatide. Thus the null hypothesis and its alternative were H0: µliraglutide = µexenatide against HA1:µliraglutide ≠ µexenatide where µliraglutide and µexenatide is the mean value of the endpoint in the liraglutide arm and exenatide arm, respectively.||-0.01|-0.13|0.0277
72567348|NCT00518882|144665584|SUPERIORITY_OR_OTHER||Mean|0.06|STANDARD_DEVIATION|0.29||0.003||95.0|0.021|0.102|||Paired t test|||A paired t test was made within the group and 95% confidence intervals for the difference between Weeks 26 and 78 were constructed. H0 was µ78 - µ26 = 0 against HA: µ78 - µ26 ≠ 0. A difference between the two means (Week 26 and Week 78) was concluded when H0 was rejected at the 5% level.||0.102|0.021|0.0030
72567349|NCT00518882|144665584|SUPERIORITY_OR_OTHER||Mean|0.03|STANDARD_DEVIATION|0.307||0.1452||95.0|-0.012|0.079|||Paired t test|||A paired t test was made within the treatment group and 95% confidence intervals for the difference between Weeks 26 and 78 were constructed. H0 was µ78 - µ26 = 0 against HA: µ78 - µ26 ≠ 0. A difference between the two means (Week 26 and Week 78) was concluded when H0 was rejected at the 5% level.||0.079|-0.012|0.1452
72567350|NCT00518882|144665585|SUPERIORITY_OR_OTHER||Mean|0.27|STANDARD_DEVIATION|0.306|<|0.0001||95.0|0.223|0.315|||Paired t test|||The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 0 and 78 were constructed. H0 was µ78- µ0=0 against HA: µ78 - µ0 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.||0.315|0.223|<0.0001
72567351|NCT00518882|144665585|SUPERIORITY_OR_OTHER||Mean|0.31|STANDARD_DEVIATION|0.346|<|0.0001||95.0|0.259|0.364|||Paired t test|||The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 0 and 78 were constructed. H0 was µ78- µ0=0 against HA: µ78 - µ0 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.||0.364|0.259|<0.0001
72567352|NCT00518882|144665586|SUPERIORITY_OR_OTHER||Estimated treatment difference, LS Mean|0.01||||0.5105||95.0|-0.02|0.04||There were no multiplicity concerns.|ANCOVA|||ANCOVA model included treatment, country and previous treatment as fixed effects and baseline value of the endpoint as covariate. The objective was to demonstrate that treatment with liraglutide was different from treatment with exenatide. Thus the null hypothesis and its alternative were H0: µliraglutide = µexenatide against HA1:µliraglutide ≠ µexenatide where µliraglutide and µexenatide is the mean value of the endpoint in the liraglutide arm and exenatide arm, respectively.||0.04|-0.02|0.5105
72567353|NCT00518882|144665587|SUPERIORITY_OR_OTHER||Mean|-0.01|STANDARD_DEVIATION|0.15||0.222||95.0|-0.034|0.008|||Paired t test|||A paired t test was made within the group and 95% confidence intervals for the difference between Weeks 26 and 78 were constructed. H0 was µ78 - µ26 = 0 against HA: µ78 - µ26 ≠ 0. A difference between the two means (Week 26 and Week 78) was concluded when H0 was rejected at the 5% level.||0.008|-0.034|0.2220
72624082|NCT04983979|144778496|OTHER||Mean Difference (Final Values)|-4.0|||||TWO_SIDED|95.0|-19.5|11.4||||||Due to the small sample size only an estimate of the difference between study arms was generated. No hypothesis tests were completed.||11.4|-19.5|
72402421|NCT01480076|144311678|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 9, PPMS. Mixed effect model for repeated measures with visit, baseline MSIS-29 physical score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
72402422|NCT01480076|144311678|SUPERIORITY_OR_OTHER|||||||0.0009|||||||mixed effect model|||Month 9, PRMS. Mixed effect model for repeated measures with visit, baseline MSIS-29 physical score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.0009
72402423|NCT01480076|144311678|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 12, RRMS. Mixed effect model for repeated measures with visit, baseline MSIS-29 physical score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
72402424|NCT01480076|144311678|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 12, SPMS. Mixed effect model for repeated measures with visit, baseline MSIS-29 physical score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
72484210|NCT03531788|144495661|OTHER|||||||||||||||||Activity counts from the ActiGraph GT9x activity monitor provide data per participant during testing of upper extremity activities/tasks and were collected while wearing the device (Kinova and WREX) and without the device (Kinova and WREX). For each upper extremity task, we summed all activity count data for all tasks completed. We then computed means and standard deviations. Data presented are within group data change and not between group data comparisons.|Due to the small sample size, we utilized change in activity count data when comparing two upper limb testing sessions: one without the use of an arm support device (Kinova or WREX) and one while using the arm support device. For each upper extremity task, we summed all activity count data for all tasks completed. We then computed means and standard deviations. Data presented are within group data change and not between group data comparisons.|||
72484211|NCT03531788|144495662|OTHER|||||||||||||||||Activity counts from the ActiGraph GT9x activity monitor were collected during baseline (without a device) and throughout the 4 week device trial (with the device). For each time period, activity count data were averaged across the day. We then compared the baseline time period to the device trial period to understand the difference in movement and upper extremity positioning during the device trial. Data presented are within group change scores and not between group data comparisons.|Counts from each axis (x, y, z) were measured across baseline and during the 4-week trial to explore arm movement and positioning during the use of an upper extremity arm device. Counts (within each participant) were summed. A change score from trial minus baseline was calculated for each axis. We provide an average change score and standard deviation across participants with Kinova and participants with WREX.|||
72484212|NCT03531788|144495663|OTHER|||||||||||||||||Three goals were identified for each participant and scored without using an arm support device to serve as a baseline measure of abilities. These scores were compared to the scores achieved on the same goals using the arm support device.|We compared the change in GAS scores when using an arm support device on three goal areas identified as important for each participant. For each goal, we measured abilities at baseline and with the device (Kinova and WREX). We calculated the change in score for each goal and averaged these change scores across all participants. While our groups are too small to complete statistical tests to estimate the significance of the differences participants noted in activity and independence while using both arm supports, our results quantify the amount of increased success participants noted with the use of the arm support device.|||
72484213|NCT04427501|144495688|SUPERIORITY||Odds Ratio (OR)|0.3|||||TWO_SIDED|95.0|0.15|0.58||||||||0.58|0.15|
72484214|NCT04427501|144495688|SUPERIORITY||Odds Ratio (OR)|0.12|||||TWO_SIDED|95.0|0.04|0.31||||||||0.31|0.04|
72484215|NCT04427501|144495689|SUPERIORITY||Odds Ratio (OR)|0.23|||||TWO_SIDED|95.0|0.13|0.4||||||||0.40|0.13|
72484216|NCT04427501|144495690|SUPERIORITY||Mean Difference (Net)|0.09|STANDARD_ERROR_OF_MEAN|0.221||0.6921|TWO_SIDED|95.0|-0.35|0.52|||Mixed Models Analysis|||||0.52|-0.35|0.6921
72484217|NCT04427501|144495690|SUPERIORITY||Mean Difference (Net)|-0.27|STANDARD_ERROR_OF_MEAN|0.219||0.211|TWO_SIDED|95.0|-0.71|0.16|||Mixed Models Analysis|||||0.16|-0.71|0.2110
72567354|NCT00518882|144665587|SUPERIORITY_OR_OTHER||Mean|0.0|STANDARD_DEVIATION|0.141||0.7923||95.0|-0.018|0.024|||Paired t test|||A paired t test was made within the treatment group and 95% confidence intervals for the difference between Weeks 26 and 78 were constructed. H0 was µ78 - µ26 = 0 against HA: µ78 - µ26 ≠ 0. A difference between the two means (Week 26 and Week 78) was concluded when H0 was rejected at the 5% level.||0.024|-0.018|0.7923
72484218|NCT04427501|144495690|SUPERIORITY||Mean Difference (Net)|0.31|STANDARD_ERROR_OF_MEAN|0.225||0.163|TWO_SIDED|95.0|-0.13|0.76|||Mixed Models Analysis|||||0.76|-0.13|0.1630
72402425|NCT01480076|144311678|SUPERIORITY_OR_OTHER|||||||0.0002|||||||mixed effect model|||Month 12, PPMS. Mixed effect model for repeated measures with visit, baseline MSIS-29 physical score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.0002
72402426|NCT01480076|144311678|SUPERIORITY_OR_OTHER|||||||0.0002|||||||mixed effect model|||Month 12, PRMS. Mixed effect model for repeated measures with visit, baseline MSIS-29 physical score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.0002
72484219|NCT04427501|144495690|SUPERIORITY||Mean Difference (Net)|-0.57|STANDARD_ERROR_OF_MEAN|0.22||0.0099|TWO_SIDED|95.0|-1.0|-0.14|||Mixed Models Analysis|||||-0.14|-1.00|0.0099
72484220|NCT04427501|144495695|SUPERIORITY||Odds Ratio (OR)|1.45|||||TWO_SIDED|95.0|1.13|1.86||||||||1.86|1.13|
72484221|NCT04427501|144495695|SUPERIORITY||Odds Ratio (OR)|1.56|||||TWO_SIDED|95.0|1.24|1.95||||||||1.95|1.24|
72484222|NCT04427501|144495695|SUPERIORITY||Odds Ratio (OR)|1.64|||||TWO_SIDED|95.0|1.06|2.53||||||||2.53|1.06|
72484223|NCT04427501|144495696|SUPERIORITY||Odds Ratio (OR)|1.5|||||TWO_SIDED|95.0|1.17|1.93||||||||1.93|1.17|
72484224|NCT04427501|144495696|SUPERIORITY||Odds Ratio (OR)|1.67|||||TWO_SIDED|95.0|1.33|2.09||||||||2.09|1.33|
72484225|NCT04427501|144495696|SUPERIORITY||Odds Ratio (OR)|1.88|||||TWO_SIDED|95.0|1.22|2.9||||||||2.9|1.22|
72484226|NCT04427501|144495697|SUPERIORITY||Odds Ratio (OR)|0.34|||||TWO_SIDED|95.0|0.18|0.64||||||||0.64|0.18|
72512096|NCT00755846|144554249|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-30.5|STANDARD_ERROR_OF_MEAN|8.4|<|0.001||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline FPG as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in FPG. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||<0.001
72512097|NCT00755846|144554249|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-22.8|STANDARD_ERROR_OF_MEAN|8.68||0.009||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline FPG as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in FPG. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.009
72512098|NCT00755846|144554249|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-29.4|STANDARD_ERROR_OF_MEAN|8.38|<|0.001||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline FPG as covariates|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in FPG. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||<0.001
72512099|NCT00755846|144554249|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.4|STANDARD_ERROR_OF_MEAN|8.57||0.057||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline FPG as covariates|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in FPG. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.057
72512100|NCT00755846|144554249|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.2|STANDARD_ERROR_OF_MEAN|8.56||0.156||95.0||||No multiplicity adjustments|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline FPG as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in FPG. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.156
72567355|NCT00518882|144665588|SUPERIORITY_OR_OTHER||Mean|-0.03|STANDARD_DEVIATION|0.159||0.0254||95.0|-0.05|-0.003|||Paired t test|||The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 0 and 78 were constructed. H0 was µ78- µ0=0 against HA: µ78 - µ0 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.||-0.003|-0.050|0.0254
72567356|NCT00518882|144665588|SUPERIORITY_OR_OTHER||Mean|-0.02|STANDARD_DEVIATION|0.165||0.2244||95.0|-0.04|0.009|||Paired t test|||The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 0 and 78 were constructed. H0 was µ78- µ0=0 against HA: µ78 - µ0 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.||0.009|-0.040|0.2244
72484227|NCT04427501|144495697|SUPERIORITY||Odds Ratio (OR)|0.17|||||TWO_SIDED|95.0|0.07|0.38||||||||0.38|0.07|
72484228|NCT04427501|144495697|SUPERIORITY||Odds Ratio (OR)|0.25|||||TWO_SIDED|95.0|0.06|1.05||||||||1.05|0.06|
72484229|NCT04427501|144495698|SUPERIORITY||Mean Difference (Net)|-1.2|||<|0|TWO_SIDED|95.0|-1.46|-0.94|||Mixed Models Analysis|||||-0.94|-1.46|<0.0000000
72484230|NCT04427501|144495698|SUPERIORITY||Mean Difference (Net)|-1.09|||<|0|TWO_SIDED|95.0|-1.34|-0.85|||Mixed Models Analysis|||||-0.85|-1.34|<0.0000000
72484231|NCT04427501|144495698|SUPERIORITY||Mean Difference (Net)|-0.99||||3.777e-05|TWO_SIDED|95.0|-1.45|-0.52|||Mixed Models Analysis|||||-0.52|-1.45|0.00003777
72484232|NCT04427501|144495699|SUPERIORITY||Hazard Ratio (HR)|1.213||||0.007|TWO_SIDED||||||Stratified Log-rank|||||||0.007
72484233|NCT04427501|144495699|SUPERIORITY||Hazard Ratio (HR)|1.111||||0.13|TWO_SIDED||||||Stratified Log-rank|||||||0.130
72484234|NCT04427501|144495699|SUPERIORITY||Hazard Ratio (HR)|1.38||||0.012|TWO_SIDED||||||Stratified Log-rank|||||||0.012
72484235|NCT04427501|144495700|SUPERIORITY||Hazard Ratio (HR)|1.355||||0.007|TWO_SIDED||||||Stratified Log-rank|||||||0.007
72484236|NCT04427501|144495700|SUPERIORITY||Hazard Ratio (HR)|1.237||||0.033|TWO_SIDED||||||Stratified Log-rank|||||||0.033
72484237|NCT04427501|144495700|SUPERIORITY||Hazard Ratio (HR)|1.521||||0.017|TWO_SIDED||||||Stratified Log-rank|||||||0.017
72484238|NCT04427501|144495701|SUPERIORITY||Mean Difference (Net)|0.16|STANDARD_ERROR_OF_MEAN|0.243||0.499|TWO_SIDED|95.0|-0.31|0.64|||Mixed Models Analysis|||||0.64|-0.31|0.499
72484239|NCT04427501|144495701|SUPERIORITY||Mean Difference (Net)|-0.17|STANDARD_ERROR_OF_MEAN|0.241||0.492|TWO_SIDED|95.0|-0.64|0.31|||Mixed Models Analysis|||||0.31|-0.64|0.492
72484240|NCT04427501|144495701|SUPERIORITY||Mean Difference (Net)|0.38|STANDARD_ERROR_OF_MEAN|0.246||0.125|TWO_SIDED|95.0|-0.11|0.86|||Mixed Models Analysis|||||0.86|-0.11|0.125
72484241|NCT04427501|144495701|SUPERIORITY||Mean Difference (Net)|-0.43|STANDARD_ERROR_OF_MEAN|0.236||0.069|TWO_SIDED|95.0|-0.89|0.03|||Mixed Models Analysis|||||0.03|-0.89|0.069
72484242|NCT04427501|144495702|SUPERIORITY||Odds Ratio (OR)|1.74||||0.034|TWO_SIDED|95.0|1.04|2.9|||Regression, Logistic|||||2.90|1.04|0.034
72484243|NCT04427501|144495702|SUPERIORITY||Odds Ratio (OR)|1.15||||0.594|TWO_SIDED|95.0|0.69|1.91|||Regression, Logistic|||||1.91|0.69|0.594
72484244|NCT04427501|144495702|SUPERIORITY||Odds Ratio (OR)|1.32||||0.291|TWO_SIDED|95.0|0.79|2.2|||Regression, Logistic|||||2.20|0.79|0.291
72484245|NCT04427501|144495702|SUPERIORITY||Odds Ratio (OR)|1.45||||0.143|TWO_SIDED|95.0|0.88|2.4|||Regression, Logistic|||||2.40|0.88|0.143
72484246|NCT04427501|144495703|SUPERIORITY||Odds Ratio (OR)|1.89||||0.014|TWO_SIDED|95.0|1.14|3.15|||Regression, Logistic|||||3.15|1.14|0.014
72567357|NCT00518882|144665589|SUPERIORITY_OR_OTHER||Estimated treatment difference, LS Mean|-0.18||||0.0485||95.0|-0.37|0.0||There were no multiplicity concerns.|ANCOVA|||ANCOVA model included treatment, country and previous treatment as fixed effects and baseline value of the endpoint as covariate. The objective was to demonstrate that treatment with liraglutide was different from treatment with exenatide. Thus the null hypothesis and its alternative were H0: µliraglutide = µexenatide against HA1:µliraglutide ≠ µexenatide where µliraglutide and µexenatide is the mean value of the endpoint in the liraglutide arm and exenatide arm, respectively.||-0.00|-0.37|0.0485
72484247|NCT04427501|144495703|SUPERIORITY||Odds Ratio (OR)|1.06||||0.828|TWO_SIDED|95.0|0.64|1.74|||Regression, Logistic|||||1.74|0.64|0.828
72484248|NCT04427501|144495703|SUPERIORITY||Odds Ratio (OR)|1.82||||0.022|TWO_SIDED|95.0|1.09|3.02|||Regression, Logistic|||||3.02|1.09|0.022
72484249|NCT04427501|144495703|SUPERIORITY||Odds Ratio (OR)|1.48||||0.119|TWO_SIDED|95.0|0.9|2.43|||Regression, Logistic|||||2.43|0.90|0.119
72484250|NCT04427501|144495706|SUPERIORITY||Odds Ratio (OR)|0.23||||0.098|TWO_SIDED|95.0|0.04|1.31|||Regression, Logistic|||||1.31|0.04|0.098
72484251|NCT04427501|144495706|SUPERIORITY||Odds Ratio (OR)|0.37||||0.165|TWO_SIDED|95.0|0.09|1.51|||Regression, Logistic|||||1.51|0.09|0.165
72484252|NCT04427501|144495706|SUPERIORITY||Odds Ratio (OR)|0.39||||0.191|TWO_SIDED|95.0|0.1|1.6|||Regression, Logistic|||||1.60|0.10|0.191
72484253|NCT04427501|144495706|SUPERIORITY||Odds Ratio (OR)|0.21||||0.075|TWO_SIDED|95.0|0.04|1.18|||Regression, Logistic|||||1.18|0.04|0.075
72484254|NCT04427501|144495707|SUPERIORITY|||||||0.616|||||||Stratified Log-rank|||||||0.616
72484255|NCT04427501|144495707|SUPERIORITY|||||||0.281|||||||Stratified Log-rank|||||||0.281
72484256|NCT04427501|144495707|SUPERIORITY|||||||0.815|||||||Stratified Log-rank|||||||0.815
72484257|NCT04427501|144495707|SUPERIORITY|||||||0.334|||||||Stratified Log-rank|||||||0.334
72484258|NCT03219320|144495759|OTHER|||||||0.004|||||||Mixed Models Analysis|||||||0.004
72484259|NCT03872453|144495763|SUPERIORITY|The stratified percentage difference between zavegepant group and placebo was tested at a Bonferroni-corrected alpha level of 0.0167.|Stratified Percentage Difference|4.2||||0.1214|TWO_SIDED|98.3|-2.3|10.7||Threshold for significance at 0.0167 level.|Cochran-Mantel-Haenszel|||||10.7|-2.3|0.1214
72484260|NCT03872453|144495763|SUPERIORITY|The stratified percentage difference between zavegepant group and placebo was tested at a Bonferroni-corrected alpha level of 0.0167.|Stratified Percentage Difference|7.0||||0.0113|TWO_SIDED|98.3|0.4|13.7||Threshold for significance at 0.0167 level.|Cochran-Mantel-Haenszel|||||13.7|0.4|0.0113
72484261|NCT03872453|144495763|SUPERIORITY|The stratified percentage difference between zavegepant group and placebo was tested at a Bonferroni-corrected alpha level of 0.0167.|Stratified Percentage Difference|7.7||||0.0055|TWO_SIDED|98.3|1.1|14.3||Threshold for significance at 0.0167 level.|Cochran-Mantel-Haenszel|||||14.3|1.1|0.0055
72484262|NCT03872453|144495764|SUPERIORITY|The stratified percentage difference between zavegepant group and placebo was tested at a Bonferroni-corrected alpha level of 0.0167.|Stratified Percentage Difference|5.4||||0.1162|TWO_SIDED|98.3|-2.8|13.6||Threshold for significance at 0.0167 level.|Cochran-Mantel-Haenszel|||||13.6|-2.8|0.1162
72484263|NCT03872453|144495764|SUPERIORITY|The stratified percentage difference between zavegepant group and placebo was tested at a Bonferroni-corrected alpha level of 0.0167.|Stratified Percentage Difference|8.3||||0.0155|TWO_SIDED|98.3|0.1|16.5||Threshold for significance at 0.0167 level.|Cochran-Mantel-Haenszel|||||16.5|0.1|0.0155
72484264|NCT03872453|144495764|SUPERIORITY|The stratified percentage difference between zavegepant group and placebo was tested at a Bonferroni-corrected alpha level of 0.0167.|Stratified Percentage Difference|8.9||||0.0094|TWO_SIDED|98.3|0.7|17.0||Threshold for significance at 0.0167 level.|Cochran-Mantel-Haenszel|||||17.0|0.7|0.0094
72484265|NCT03872453|144495765|SUPERIORITY|The stratified percentage difference between zavegepant group and placebo was tested at a Bonferroni-corrected alpha level of 0.0167.|Stratified Percentage Difference|7.1||||0.0439|TWO_SIDED|98.3|-1.3|15.4||Threshold for significance at 0.0167 level.|Cochran-Mantel-Haenszel|||If the coprimary endpoint tests were both significant for a zavegepant dose group versus placebo, the secondary endpoints were tested for that zavegepant dose group versus placebo using a hierarchical gate-keeping procedure in the order the endpoints are reported, with each test in the hierarchy conducted at alpha = 0.0167. If a test in the hierarchy was not significant, any further tests on endpoints in the sequence were not considered significant for any zavegepant dose group versus placebo.||15.4|-1.3|0.0439
72484266|NCT03872453|144495765|SUPERIORITY|The stratified percentage difference between zavegepant group and placebo was tested at a Bonferroni-corrected alpha level of 0.0167.|Stratified Percentage Difference|7.5||||0.0302|TWO_SIDED|98.3|-0.8|15.9||Threshold for significance at 0.0167 level.|Cochran-Mantel-Haenszel|||If the coprimary endpoint tests were both significant for a zavegepant dose group versus placebo, the secondary endpoints were tested for that zavegepant dose group versus placebo using a hierarchical gate-keeping procedure in the order the endpoints are reported, with each test in the hierarchy conducted at alpha = 0.0167. If a test in the hierarchy was not significant, any further tests on endpoints in the sequence were not considered significant for any zavegepant dose group versus placebo.||15.9|-0.8|0.0302
72484267|NCT00863109|144495796|SUPERIORITY_OR_OTHER|||||||0.027|||||||Student´s t-test for paired samples|||Within-group comparison of Worry domain between BL Visit and WK72 Visit||||0.027
72484268|NCT00863109|144495797|SUPERIORITY_OR_OTHER|||||||0.038|||||||Student´s t-test for paired samples|||Between-group comparison of change from baseline in MCS||||0.038
72567358|NCT00518882|144665590|SUPERIORITY_OR_OTHER||Mean|0.1|STANDARD_DEVIATION|0.82||0.1161||95.0|-0.02|0.21|||Paired t test|||A paired t test was made within the group and 95% confidence intervals for the difference between Weeks 26 and 78 were constructed. H0 was µ78 - µ26 = 0 against HA: µ78 - µ26 ≠ 0. A difference between the two means (Week 26 and Week 78) was concluded when H0 was rejected at the 5% level.||0.21|-0.02|0.1161
72484269|NCT00863109|144495798|SUPERIORITY_OR_OTHER|||||||0.014|||||||Student´s t-test for paired samples|||Between-group comparison of change from baseline in Emotional Function domain||||0.014
72484270|NCT00863109|144495798|SUPERIORITY_OR_OTHER|||||||0.009|||||||Student´s t-test for paired samples|||Between-group comparison of change from baseline in Worry domain||||0.009
72484271|NCT00863109|144495798|SUPERIORITY_OR_OTHER|||||||0.022|||||||Student´s t-test for paired samples|||Between-group comparison of change from baseline in CLDQ-HCV Global domain||||0.022
72484272|NCT00440700|144495803|SUPERIORITY_OR_OTHER||Slope|15.5|||<|0.05||95.0|||||Mixed Models Analysis|||Mixed models analysis was used to determine if there were any differences in anxiety levels in patients who listen to music as compared to headphones only or usual ICU care.||||<0.05
72484273|NCT00440700|144495805|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.5|STANDARD_ERROR_OF_MEAN|0.61|<|0.05|ONE_SIDED|95.0|||||Kruskal-Wallis||Usual care was the reference comparison group.|Length of mechanical ventilatory support was assessed among all 3 groups. Usual usual care was the reference group as compared to the experimental patient-directed music group.||||<0.05
72484274|NCT00440700|144495806|SUPERIORITY_OR_OTHER||Slope|5.0|||<|0.05||95.0|||||Mixed Models Analysis|||Cortisol levels were compared among all 3 groups.||||<0.05
72484275|NCT03739762|144495807|SUPERIORITY||Mean Difference (Final Values)|-31.85||||0.003|TWO_SIDED|95.0|-52.91|-10.79|||Regression, Linear|The model fit was a linear regression model with GEE on the outcome change from baseline.||The sample size of 284 ensured 90% power to detect a 41-minute difference in sitting time between I-STAND and the attention control from baseline to 6 months, assuming a standard deviation (SD) of 97 minutes/day for change in sitting time (based on our pilot data), and 15% loss to follow-up. Sample and power calculations were performed using R software version 3.5 \[39\] via simulation, assuming specified SDs and differences between means.||-10.79|-52.91|0.003
72484276|NCT03739762|144495808|SUPERIORITY||Mean Difference (Final Values)|-3.48||||0.033|TWO_SIDED|95.0|-6.68|-0.28|||Regression, Linear|The model fit was a linear regression model with GEE on the outcome change from baseline.||||-0.28|-6.68|.033
72484277|NCT03739762|144495809|SUPERIORITY||Mean Difference (Final Values)|0.27||||0.784|TWO_SIDED|95.0|-1.63|2.16|||Regression, Linear|The model fit was a linear regression model with GEE on the outcome change from baseline.||||2.16|-1.63|.784
72484278|NCT03739762|144495810|SUPERIORITY||Mean Difference (Final Values)|-0.12||||0.927|TWO_SIDED|95.0|-2.61|2.38|||Regression, Linear|The model fit was a linear regression model with GEE on the outcome change from baseline.||||2.38|-2.61|.927
72484279|NCT03739762|144495811|SUPERIORITY||Mean Difference (Final Values)|0.02||||0.916|TWO_SIDED|95.0|-0.42|0.47|||Regression, Linear|The model fit was a linear regression model with GEE on the outcome change from baseline.||||0.47|-0.42|.916
72512101|NCT00755846|144554250|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-23.9|STANDARD_ERROR_OF_MEAN|7.05|<|0.001||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline FPG as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between all doses of alogliptin and placebo arms in change from baseline in FPG. The treatment effect was evaluated as a contrast of all doses of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||<0.001
72512102|NCT00755846|144554250|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-29.4|STANDARD_ERROR_OF_MEAN|8.91||0.001||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline FPG as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in FPG. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.001
72512103|NCT00755846|144554250|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-24.6|STANDARD_ERROR_OF_MEAN|9.2||0.008||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline FPG as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in FPG. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.008
72567359|NCT00518882|144665590|SUPERIORITY_OR_OTHER||Mean|0.0|STANDARD_DEVIATION|0.96||0.7888||95.0|-0.16|0.12|||Paired t test|||A paired t test was made within the treatment group and 95% confidence intervals for the difference between Weeks 26 and 78 were constructed. H0 was µ78 - µ26 = 0 against HA: µ78 - µ26 ≠ 0. A difference between the two means (Week 26 and Week 78) was concluded when H0 was rejected at the 5% level.||0.12|-0.16|0.7888
72484280|NCT03739762|144495812|SUPERIORITY||Mean Difference (Final Values)|-0.36||||0.325|TWO_SIDED|95.0|-1.09|0.36|||Regression, Linear|The model fit was a linear regression model with GEE on the outcome change from baseline.||||0.36|-1.09|.325
72484281|NCT02294682|144495813|SUPERIORITY_OR_OTHER||Microbio Response Urogenital Gonorrhea|97.0|||||ONE_SIDED|95.0|85.1||||||GSK2140944 1500 mg||||85.1|
72484282|NCT02294682|144495813|SUPERIORITY_OR_OTHER||Microbio Response Urogenital Gonorrhea|95.0|||||ONE_SIDED|95.0|84.7||||||GSK2140944 3000 mg||||84.7|
72484283|NCT00733304|144495855|SUPERIORITY||Mean Difference (Net)|-0.43|STANDARD_ERROR_OF_MEAN|1.362|||TWO_SIDED|95.0|-3.18|2.31||Analysis of covariance (ANCOVA) model was used to perform statistical analysis based on treatment, visit, fixed effect terms etc.|ANCOVA|||Month 2 versus screening visit||2.31|-3.18|
72484284|NCT00733304|144495855|SUPERIORITY||Mean Difference (Net)|-3.8|STANDARD_ERROR_OF_MEAN|1.659|||TWO_SIDED|95.0|-7.13|-0.46||Analysis of covariance (ANCOVA) model was used to perform statistical analysis based on treatment, visit, fixed effect terms etc.|ANCOVA|||Month 5 versus screening visit||-0.46|-7.13|
72402427|NCT01480076|144311679|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Overall, RRMS. Mixed effect model for repeated measures with visit, baseline MSIS-29 psychological score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
72484285|NCT00733304|144495855|SUPERIORITY||Mean Difference (Net)|-4.15|STANDARD_ERROR_OF_MEAN|1.672|||TWO_SIDED|95.0|-7.52|-0.78||Analysis of covariance (ANCOVA) model was used to perform statistical analysis based on treatment, visit, fixed effect terms etc.|ANCOVA|||Month 2 versus screening visit||-0.78|-7.52|
72402428|NCT01480076|144311679|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Overall, SPMS. Mixed effect model for repeated measures with visit, baseline MSIS-29 psychological score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
72402429|NCT01480076|144311679|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Overall, PPMS. Mixed effect model for repeated measures with visit, baseline MSIS-29 psychological score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
72484286|NCT00733304|144495855|SUPERIORITY||Mean Difference (Net)|-4.03|STANDARD_ERROR_OF_MEAN|1.74|||TWO_SIDED|95.0|-7.53|0.53||Analysis of covariance (ANCOVA) model was used to perform statistical analysis based on treatment, visit, fixed effect terms etc.|ANCOVA|||Month 5 versus screening visit||0.53|-7.53|
72484287|NCT00733304|144495856|SUPERIORITY||Mean Difference (Net)|8.28|STANDARD_ERROR_OF_MEAN|16.899|||TWO_SIDED|95.0|-25.72|42.29||ANCOVA model was used to perform statistical analysis based on treatment, visit, fixed effect terms, Baseline OCT central subfield as covariate, and participant within treatment as a random effect term.|ANCOVA|||For Month 1 versus Screening visit||42.29|-25.72|
72484288|NCT00733304|144495856|SUPERIORITY||Mean Difference (Net)|-1.21|STANDARD_ERROR_OF_MEAN|17.177|||TWO_SIDED|95.0|-35.73|33.31||ANCOVA model was used to perform statistical analysis based on treatment, visit, fixed effect terms, Baseline OCT central subfield as covariate, and participant within treatment as a random effect term.|ANCOVA|||Month 2 versus Screening visit||33.31|-35.73|
72484289|NCT00733304|144495856|SUPERIORITY||Mean Difference (Net)|-5.11|STANDARD_ERROR_OF_MEAN|17.958|||TWO_SIDED|95.0|-41.08|30.86||ANCOVA model was used to perform statistical analysis based on treatment, visit, fixed effect terms, Baseline OCT central subfield as covariate, and participant within treatment as a random effect term.|ANCOVA|||Month 3 versus Screening visit||30.86|-41.08|
72402430|NCT01480076|144311679|SUPERIORITY_OR_OTHER|||||||0.0032|||||||mixed effect model|||Overall, PRMS. Mixed effect model for repeated measures with visit, baseline MSIS-29 psychological score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.0032
72402431|NCT01480076|144311679|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 3, RRMS. Mixed effect model for repeated measures with visit, baseline MSIS-29 psychological score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
72402432|NCT01480076|144311679|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 3, SPMS. Mixed effect model for repeated measures with visit, baseline MSIS-29 psychological score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
72484290|NCT00733304|144495856|SUPERIORITY||Mean Difference (Net)|-9.92|STANDARD_ERROR_OF_MEAN|18.996|||TWO_SIDED|95.0|-47.83|28.0||ANCOVA model was used to perform statistical analysis based on treatment, visit, fixed effect terms, Baseline OCT central subfield as covariate, and participant within treatment as a random effect term.|ANCOVA|||Month 4 versus Screening visit||28.00|-47.83|
72512104|NCT00755846|144554250|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-35.5|STANDARD_ERROR_OF_MEAN|8.88|<|0.001||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and body mass index, diabetes duration, and baseline HbA1c as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in FPG. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||<0.001
72484291|NCT00733304|144495856|SUPERIORITY||Mean Difference (Net)|2.42|STANDARD_ERROR_OF_MEAN|18.996|||TWO_SIDED|95.0|-35.5|40.33||ANCOVA model was used to perform statistical analysis based on treatment, visit, fixed effect terms, Baseline OCT central subfield as covariate, and participant within treatment as a random effect term.|ANCOVA|||Month 5 versus Screening visit||40.33|-35.50|
72484292|NCT00733304|144495856|SUPERIORITY||Mean Difference (Net)|9.05|STANDARD_ERROR_OF_MEAN|20.931|||TWO_SIDED|95.0|-33.09|51.2||ANCOVA model was used to perform statistical analysis based on treatment, visit, fixed effect terms, Baseline OCT central subfield as covariate, and participant within treatment as a random effect term.|ANCOVA|||Month 1 versus Screening visit||51.20|-33.09|
72484293|NCT00733304|144495856|SUPERIORITY||Mean Difference (Net)|-1.24|STANDARD_ERROR_OF_MEAN|21.29|||TWO_SIDED|95.0|-44.05|41.57||ANCOVA model was used to perform statistical analysis based on treatment, visit, fixed effect terms, Baseline OCT central subfield as covariate, and participant within treatment as a random effect term.|ANCOVA|||Month 2 versus Screening visit||41.57|-44.05|
72567360|NCT00518882|144665591|SUPERIORITY_OR_OTHER||Mean|-0.3|STANDARD_DEVIATION|1.07||0.0003||95.0|-0.43|-0.13|||Paired t test|||The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 0 and 78 were constructed. H0 was µ78- µ0=0 against HA: µ78 - µ0 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.||-0.13|-0.43|0.0003
72484294|NCT00733304|144495856|SUPERIORITY||Mean Difference (Net)|15.39|STANDARD_ERROR_OF_MEAN|21.757|||TWO_SIDED|95.0|-28.28|59.06||ANCOVA model was used to perform statistical analysis based on treatment, visit, fixed effect terms, Baseline OCT central subfield as covariate, and participant within treatment as a random effect term.|ANCOVA|||Month 3 versus Screening visit||59.06|-28.28|
72484295|NCT00733304|144495856|SUPERIORITY||Mean Difference (Net)|-16.82|STANDARD_ERROR_OF_MEAN|22.183|||TWO_SIDED|95.0|-61.28|27.63||ANCOVA model was used to perform statistical analysis based on treatment, visit, fixed effect terms, Baseline OCT central subfield as covariate, and participant within treatment as a random effect term.|ANCOVA|||Month 4 versus Screening visit||27.63|-61.28|
72484296|NCT00733304|144495856|SUPERIORITY||Mean Difference (Net)|-2.16|STANDARD_ERROR_OF_MEAN|21.757|||TWO_SIDED|95.0|-45.83|41.51||ANCOVA model was used to perform statistical analysis based on treatment, visit, fixed effect terms, Baseline OCT central subfield as covariate, and participant within treatment as a random effect term.|ANCOVA|||Month 5 versus Screening visit||41.51|-45.83|
72484297|NCT01187550|144495859|SUPERIORITY_OR_OTHER|||||||0.194||95.0|||||Wilcoxon rank sum test|||||||0.194
72484298|NCT01187550|144495860|SUPERIORITY_OR_OTHER|||||||0.752||95.0|||||Wilcoxon rank sum test|||||||0.752
72484299|NCT01187550|144495861|SUPERIORITY_OR_OTHER|||||||0.71||95.0|||||Wilcoxon rank sum test|||||||0.710
72484300|NCT01187550|144495862|SUPERIORITY_OR_OTHER|||||||0.265||95.0|||||Wilcoxon rank sum test|||||||0.265
72484301|NCT01187550|144495863|SUPERIORITY_OR_OTHER|||||||0.308||95.0|||||Wilcoxon rank sum test|||||||0.308
72484302|NCT01187550|144495864|SUPERIORITY_OR_OTHER|||||||0.078||95.0|||||Wilcoxon rank sum test|||For total cholesterol: Wilcoxon rank sum test was used to calculate p-value.||||0.078
72484303|NCT01187550|144495864|SUPERIORITY_OR_OTHER|||||||0.033||95.0|||||Wilcoxon rank sum test|||For HDL-cholesterol: Wilcoxon rank sum test was used to calculate p-value.||||0.033
72512105|NCT00755846|144554250|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.6|STANDARD_ERROR_OF_MEAN|9.09||0.136||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline HbA1c as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in FPG. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.136
72567361|NCT00518882|144665591|SUPERIORITY_OR_OTHER||Mean|-0.1|STANDARD_DEVIATION|1.47||0.2078||95.0|-0.35|0.08|||Paired t test|||The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 0 and 78 were constructed. H0 was µ78- µ0=0 against HA: µ78 - µ0 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.||0.08|-0.35|0.2078
72484304|NCT01187550|144495864|SUPERIORITY_OR_OTHER|||||||0.041||95.0|||||Wilcoxon rank sum test|||For LDL-cholesterol: Wilcoxon rank sum test was used to calculate p-value.||||0.041
72484305|NCT01187550|144495864|SUPERIORITY_OR_OTHER|||||||0.091||95.0|||||Wilcoxon rank sum test|||For triglycerides: Wilcoxon rank sum test was used to calculate p-value.||||0.091
72484306|NCT00129623|144495865|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.1226|||<|0.0001|TWO_SIDED|95.0|2.9613|5.2838||The primary analysis was an ANOVA (two way classification), including treatment group and time since menopause (as a binary variable; 0.5-3 years, \>3 years) as independent factors.|ANOVA|||"H0 (null hypothesis): There was no statistically significant difference between monthly treatment with 150 mg oral IBN and monthly treatment with placebo in relative change from baseline of mean lumbar spine (L2-L4 BMD).~H1 (alternative hypothesis): There was a statistically significant difference between monthly treatment with 150 mg oral IBN and monthly treatment with placebo in relative change from baseline of mean lumbar spine (L2-L4 BMD)."||5.2838|2.9613|<0.0001
72484307|NCT00129623|144495871|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|12.51|||||TWO_SIDED|95.0|5.12|30.56||||||Lumbar BMD: Adjusted treatment effect - The treatment effect and 95% C.I. were represented by presenting OR. These were estimated by fitting a logistic regression model, with responder outcome (responder/non-responder) as the dependent variable and the treatment group (oral IBN 150 mg/Placebo) and time since menopause as the independent variables. An OR of \>1 indicated participants treated with IBN were more likely to have BMD above or equal to baseline relative to those treated with placebo.||30.56|5.12|
72484308|NCT00129623|144495871|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|8.59|||||TWO_SIDED|95.0|3.8|19.42||||||Proximal femur BMD: The adjusted treatment effect and 95% C.I. were represented by presenting OR. These were estimated by fitting a logistic regression model, with responder outcome (responder/non-responder) as the dependent variable and the treatment group (oral IBN 150 mg once monthly/Placebo) and time since menopause as the independent variables. An OR of \>1 indicated participants treated with IBN were more likely to have BMD above or equal to baseline relative to those treated with placebo.||19.42|3.80|
72484309|NCT00129623|144495871|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|13.8|||||TWO_SIDED|95.0|5.17|36.79||||||Lumbar Spine and Proximal Femur BMD: The adjusted treatment effect and 95% C.I. were represented by presenting OR. These were estimated by fitting a logistic regression model, with responder outcome (responder/non-responder) as the dependent variable, and treatment group (oral IBN150 mg/Placebo) and time since menopause as the independent variables. An OR of \>1 indicated participants treated with IBN were more likely to have BMD above or equal to baseline relative to those treated with placebo.||36.79|5.17|
72484310|NCT02616614|144495879|EQUIVALENCE|Bioequivalence was established if the 90% CI for the difference was contained within the interval \[0.80,1.25\] for the PP population.|Mean Difference (Net)|0.95|||||TWO_SIDED|90.0|0.88|1.03||||||||1.03|0.88|
72484311|NCT02616614|144495879|SUPERIORITY|||||||0.0001|||||||ANOVA|||||||0.0001
72484312|NCT02616614|144495879|SUPERIORITY||||||<|0.0001|||||||ANOVA|||||||<0.0001
72484313|NCT02616614|144495880|EQUIVALENCE|Bioequivalence was established if the 90% CI for the difference was contained within the interval \[0.80, 1.25\] for the PP population.|Mean Difference (Net)|1.0|||||TWO_SIDED|90.0|0.9|1.11||||||||1.11|0.90|
72484314|NCT02616614|144495880|SUPERIORITY|||||||0.0002|||||||ANOVA|||||||0.0002
72484315|NCT02616614|144495880|SUPERIORITY|||||||0.0006|||||||ANOVA|||||||0.0006
72484316|NCT02616614|144495881|EQUIVALENCE|Bioequivalence was established if the 90% CI for the difference was contained within the interval (-0.20, +0.20).|Mean Difference (Net)|-0.022|||||TWO_SIDED|90.0|-0.087|0.043|||||Equivalence was based on difference in the number of subjects with success. Bioequivalence was established if the 90% CI for the difference was contained within the interval (-0.20, +0.20).|Bioequivalence was established if the 90% CI for the difference was contained within the interval (-0.20, +0.20).||0.043|-0.087|
72484317|NCT05178134|144495882|NON_INFERIORITY|Non-inferiority margin was set to -15% (on an absolute scale)|Difference in response rates|-0.02|||||TWO_SIDED|95.0|-0.108|0.069||||||||0.069|-0.108|
72484318|NCT00596934|144495885|SUPERIORITY_OR_OTHER|||||||0.015|||||||t-test, 2 sided|||Differences in each collected parameter will be evaluated using a paired t-test. If data are skewed such as in triglyceride levels, nonparametric tests will be used. P\<0.05 will be considered significant. If a significant difference can be demonstrated between baseline and 1-year results, a large scale, placebo-controlled trial will be designed using the data obtained from this pilot study||||0.015
72484319|NCT00596934|144495886|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
72484320|NCT00596934|144495887|SUPERIORITY_OR_OTHER|||||||0.074||||||p = 0.074|t-test, 2 sided|||||||0.074
72484321|NCT00596934|144495888|SUPERIORITY_OR_OTHER|||||||0.003|||||||t-test, 2 sided|||||||0.003
72484322|NCT00596934|144495889|SUPERIORITY_OR_OTHER|||||||0.006|||||||t-test, 2 sided|||||||0.006
72484323|NCT00596934|144495890|SUPERIORITY_OR_OTHER|||||||0.023|||||||t-test, 2 sided|||||||0.023
72484324|NCT00596934|144495891|SUPERIORITY_OR_OTHER|||||||0.195||||||p-value = 0.195.|t-test, 2 sided|||||||0.195
72484325|NCT00596934|144495892|SUPERIORITY_OR_OTHER|||||||0.026|||||||t-test, 2 sided|||||||0.026
72484326|NCT03239483|144495894|SUPERIORITY|||||||0.072|||||||Fisher Exact|||two-sided Fisher's Exact Test||||0.072
72484327|NCT03239483|144495899|SUPERIORITY|||||||1||||||This is a calculated p-value. P-values of 1.0 are possible when using the Fisher Exact test method.|Fisher Exact|||||||1.00
72484328|NCT03239483|144495900|SUPERIORITY|||||||0.591|||||||Fisher Exact|||||||0.591
72484329|NCT01214187|144495901|SUPERIORITY||Mean Difference (Net)|-1.04|STANDARD_ERROR_OF_MEAN|0.81||0.2072|TWO_SIDED||||||ANOVA|Repeated measure ANOVA|Difference = (Change from baseline to Week 12 for Carbon monoxide group) minus (Change from baseline to Week 12 for Placebo group)|||||0.2072
72484330|NCT01214187|144495902|SUPERIORITY||Mean Difference (Net)|-0.85|STANDARD_ERROR_OF_MEAN|1.57||0.5882|TWO_SIDED||||||ANOVA|Repeated Measure ANOVA|Difference = (Change from baseline to week 12 for CO group) minus (Change from baseline to week 12 for placebo group)|||||0.5882
72484331|NCT01214187|144495903|SUPERIORITY||Mean Difference (Net)|0.64|STANDARD_ERROR_OF_MEAN|1.93||0.7401|TWO_SIDED||||||ANOVA|Repeated Measure ANOVA|difference=(change from baseline to week 12 for CO group) minus (change from baseline to week 12 for placebo group)|||||0.7401
72484332|NCT01214187|144495904|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-48.46|STANDARD_ERROR_OF_MEAN|18.14||0.0099|TWO_SIDED||||||ANOVA|Repeated measure ANOVA|Difference=(Change from baseline to week 12 for CO group) minus (Change from baseline to week 12 for placebo group)|||||0.0099
72484333|NCT01214187|144495905|SUPERIORITY||Mean Difference (Net)|-0.58|STANDARD_ERROR_OF_MEAN|2.42||0.8124|TWO_SIDED||||||ANOVA|Repeated measure ANOVA||||||0.8124
72484334|NCT01178333|144495906|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.98||||0.09|TWO_SIDED|95.0|0.9|4.36|||Regression, Cox|||||4.36|0.90|0.09
72484335|NCT01178333|144495906|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.31||||0.45|TWO_SIDED|95.0|0.65|2.66|||Regression, Cox|||||2.66|0.65|0.45
72484336|NCT01178333|144495908|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|4.76||||0.15|TWO_SIDED|95.0|0.55|40.87|||Regression, Cox|||||40.87|0.55|0.15
72484337|NCT01178333|144495908|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.35||||0.78|TWO_SIDED|95.0|0.16|11.25|||Regression, Cox|||||11.25|0.16|0.78
72484338|NCT01178333|144495909|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.38||||0.06|TWO_SIDED|95.0|0.98|5.79|||Regression, Cox|||||5.79|0.98|0.06
72484339|NCT01178333|144495909|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.91||||0.11|TWO_SIDED|95.0|0.87|4.21|||Regression, Cox|||||4.21|0.87|0.11
72484340|NCT01178333|144495910|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.8||||0.001|TWO_SIDED|95.0|1.5|5.22|||Regression, Cox|||||5.22|1.50|0.001
72484341|NCT01178333|144495910|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.97||||0.02|TWO_SIDED|95.0|1.12|3.45|||Regression, Cox|||||3.45|1.12|0.02
72484342|NCT01178333|144495913|SUPERIORITY_OR_OTHER|||||||0.72|TWO_SIDED|||||P-value is to compare three groups.|Chi-squared|||||||0.72
72484343|NCT01178333|144495914|SUPERIORITY_OR_OTHER|||||||0.37|TWO_SIDED|||||P-value is to compare three groups.|Chi-squared|||||||0.37
72484344|NCT01178333|144495915|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED|||||P-value is to compare three groups.|Chi-squared|||||||0.02
72484345|NCT01178333|144495916|SUPERIORITY_OR_OTHER|||||||0.58|TWO_SIDED||||||ANOVA|||||||0.58
72484346|NCT01178333|144495917|SUPERIORITY_OR_OTHER|||||||0.66|TWO_SIDED||||||Regression, Cox|||||||0.66
72484347|NCT01178333|144495918|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED|||||P-value is to compare three groups.|Chi-squared|||||||<0.01
72484348|NCT01178333|144495919|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.48||||0.003|TWO_SIDED|95.0|1.35|4.55|||Regression, Cox|||||4.55|1.35|0.003
72484349|NCT01178333|144495919|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.66||||0.07|TWO_SIDED|95.0|0.96|2.85|||Regression, Cox|||||2.85|0.96|0.07
72484350|NCT01178333|144495921|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED|||||P-value is to compare three groups.|Chi-squared|||||||<0.01
72567362|NCT00518882|144665592|SUPERIORITY_OR_OTHER||Estimated treatment difference, LS Mean|-0.07||||0.0014||95.0|-0.11|-0.03||There were no multiplicity concerns.|ANCOVA|||ANCOVA model included treatment, country and previous treatment as fixed effects and baseline value of the endpoint as covariate. The objective was to demonstrate that treatment with liraglutide was different from treatment with exenatide. Thus the null hypothesis and its alternative were H0: µliraglutide = µexenatide against HA1:µliraglutide ≠ µexenatide where µliraglutide and µexenatide is the mean value of the endpoint in the liraglutide arm and exenatide arm, respectively.||-0.03|-0.11|0.0014
72567363|NCT00518882|144665593|SUPERIORITY_OR_OTHER||Mean|0.06|STANDARD_DEVIATION|0.269||0.0018||95.0|0.023|0.098|||Paired t test|||A paired t test was made within the group and 95% confidence intervals for the difference between Weeks 26 and 78 were constructed. H0 was µ78 - µ26 = 0 against HA: µ78 - µ26 ≠ 0. A difference between the two means (Week 26 and Week 78) was concluded when H0 was rejected at the 5% level.||0.098|0.023|0.0018
72567364|NCT00518882|144665593|SUPERIORITY_OR_OTHER||Mean|0.01|STANDARD_DEVIATION|0.272||0.5499||95.0|-0.028|0.052|||Paired t test|||A paired t test was made within the treatment group and 95% confidence intervals for the difference between Weeks 26 and 78 were constructed. H0 was µ78 - µ26 = 0 against HA: µ78 - µ26 ≠ 0. A difference between the two means (Week 26 and Week 78) was concluded when H0 was rejected at the 5% level.||0.052|-0.028|0.5499
72484351|NCT01178333|144495922|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.92||||0.72|TWO_SIDED|95.0|0.56|1.49|||Regression, Cox|||||1.49|0.56|0.72
72484352|NCT01178333|144495922|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.82||||0.34|TWO_SIDED|95.0|0.54|1.24|||Regression, Cox|||||1.24|0.54|0.34
72484353|NCT01233869|144495923|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|3.86|||<|0.0001|TWO_SIDED|95.0|2.02|5.74|||Mixed Models Analysis|||Statistical Analysis 1 is comparison of annualized rate of kidney enlargement: placebo versus pooled bosutinib.||5.74|2.02|<0.0001
72484354|NCT01233869|144495923|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|1.83||||0.1234|TWO_SIDED|95.0|-0.5|4.22|||Mixed Models Analysis|||Statistical Analysis 2 is comparison of annualized rate of kidney enlargement: bosutinib 200 mg/day versus bosutinib 400/200 mg/day.||4.22|-0.50|0.1234
72484355|NCT01233869|144495923|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|3.06||||0.005|TWO_SIDED|95.0|0.93|5.23|||Mixed Models Analysis|||Statistical Analysis 3 is comparison of annualized rate of kidney enlargement: placebo versus bosutinib 200 mg/day.||5.23|0.93|0.0050
72484356|NCT01233869|144495923|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|3.41||||0.1336|TWO_SIDED|95.0|-1.03|8.05|||Mixed Models Analysis|||Statistical Analysis 4 is comparison of annualized rate of kidney enlargement: placebo versus bosutinib 400 mg/day.||8.05|-1.03|0.1336
72484357|NCT01233869|144495923|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|4.95|||<|0.0001|TWO_SIDED|95.0|2.65|7.3|||Mixed Models Analysis|||Statistical Analysis 5 is comparison of annualized rate of kidney enlargement: placebo versus bosutinib 400/200 mg/day.||7.30|2.65|<0.0001
72484358|NCT00537485|144495948|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.3|STANDARD_ERROR_OF_MEAN|1.2||0.002|TWO_SIDED|95.0|-3.7|1.1|||t-test, 2 sided|||||1.1|-3.7|0.002
72484359|NCT00537485|144495949|SUPERIORITY_OR_OTHER||Risk Difference (RD)|30.7|||<|0.001|TWO_SIDED|95.0|16.7|44.6|||Chi-squared, Corrected|||||44.6|16.7|<0.001
72567365|NCT00518882|144665594|SUPERIORITY_OR_OTHER||Mean|-0.1|STANDARD_DEVIATION|0.273|<|0.0001||95.0|-0.14|-0.062|||Paired t test|||The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 0 and 78 were constructed. H0 was µ78- µ0=0 against HA: µ78 - µ0 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.||-0.062|-0.140|<0.0001
72484360|NCT00537485|144495949|SUPERIORITY_OR_OTHER||Risk Difference (RD)|26.1|||<|0.001|TWO_SIDED|95.0|12.0|40.2|||Chi-squared, Corrected|||||40.2|12.0|<0.001
72484361|NCT01241552|144495958|SUPERIORITY_OR_OTHER||Adjusted Difference|-1.7||||0.3182|TWO_SIDED|95.0|-8.6|5.5||One sided p-value based on the Miettinen and Nurminen method stratified by SOC therapy (metronidazole vs. vancomycin vs. fidaxomicin) and hospitalization status (inpatient vs. outpatient).|Miettinen and Nurminen||Adjusted Difference: MK-3415 + SOC - Placebo + SOC|||5.5|-8.6|0.3182
72512106|NCT00755846|144554250|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.3|STANDARD_ERROR_OF_MEAN|9.07||0.073||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline HbA1c as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in FPG. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.073
72512107|NCT00755846|144554251|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.5|STANDARD_ERROR_OF_MEAN|5.85|<|0.001||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline fasting fructosamine as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in fasting fructosamine. The treatment effect will be evaluated as a contrast of all doses of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||<0.001
72567366|NCT00518882|144665594|SUPERIORITY_OR_OTHER||Mean|-0.07|STANDARD_DEVIATION|0.302||0.0012||95.0|-0.118|-0.03|||Paired t test|||A paired t test was made within the treatment group and 95% confidence intervals for the difference between Weeks 26 and 78 were constructed. H0 was µ78 - µ26 = 0 against HA: µ78 - µ26 ≠ 0. A difference between the two means (Week 26 and Week 78) was concluded when H0 was rejected at the 5% level.||-0.030|-0.118|0.0012
72484362|NCT01241552|144495958|SUPERIORITY_OR_OTHER||Adjusted Difference|-10.1||||0.0003|TWO_SIDED|95.0|-15.9|-4.3||One sided p-value based on the Miettinen and Nurminen method stratified by SOC therapy (metronidazole vs. vancomycin vs. fidaxomicin) and hospitalization status (inpatient vs. outpatient).|Miettinen and Nurminen||Adjusted Difference: MK-6072 + SOC - Placebo + SOC|||-4.3|-15.9|0.0003
72484363|NCT01241552|144495958|SUPERIORITY_OR_OTHER||Adjusted Difference|-11.6|||<|0.0001|TWO_SIDED|95.0|-17.4|-5.9||One sided p-value based on the Miettinen and Nurminen method stratified by SOC therapy (metronidazole vs. vancomycin vs. fidaxomicin) and hospitalization status (inpatient vs. outpatient).|Miettinen and Nurminen||Adjusted Difference: MK-3415A + SOC - Placebo + SOC|||-5.9|-17.4|< 0.0001
72484364|NCT01241552|144495958|SUPERIORITY_OR_OTHER||Adjusted Difference|-9.9||||0.0013|TWO_SIDED|95.0|-16.9|-3.4||One sided p-value based on the Miettinen and Nurminen method stratified by SOC therapy (metronidazole vs. vancomycin vs. fidaxomicin) and hospitalization status (inpatient vs. outpatient).|Miettinen and Nurminen||Adjusted Difference: MK-3415A + SOC - MK-3415 + SOC|||-3.4|-16.9|0.0013
72484365|NCT01241552|144495958|SUPERIORITY_OR_OTHER||Adjusted Difference|-1.4||||0.2997|TWO_SIDED|95.0|-6.7|3.9||One sided p-value based on the Miettinen and Nurminen method stratified by SOC therapy (metronidazole vs. vancomycin vs. fidaxomicin) and hospitalization status (inpatient vs. outpatient).|Miettinen and Nurminen||Adjusted Difference: MK-3415A + SOC - MK-6072 + SOC|||3.9|-6.7|0.2997
72484366|NCT01241552|144495959|SUPERIORITY_OR_OTHER||Adjusted Difference|-8.3||||0.9775|TWO_SIDED|95.0|-16.3|-0.2||One sided p-value based on the Miettinen and Nurminen method stratified by SOC therapy (metronidazole vs. vancomycin vs. fidaxomicin) and hospitalization status (inpatient vs. outpatient).|Miettinen and Nurminen||Adjusted Difference: MK-3415 + SOC - Placebo + SOC|||-0.2|-16.3|0.9775
72484367|NCT01241552|144495959|SUPERIORITY_OR_OTHER||Adjusted Difference|4.8||||0.0861|TWO_SIDED|95.0|-2.1|11.7||One sided p-value based on the Miettinen and Nurminen method stratified by SOC therapy (metronidazole vs. vancomycin vs. fidaxomicin) and hospitalization status (inpatient vs. outpatient).|Miettinen and Nurminen||Adjusted Difference: MK-6072 + SOC - Placebo + SOC|||11.7|-2.1|0.0861
72484368|NCT01241552|144495959|SUPERIORITY_OR_OTHER||Adjusted Difference|3.5||||0.1646|TWO_SIDED|95.0|-3.5|10.4||One sided p-value based on the Miettinen and Nurminen method stratified by SOC therapy (metronidazole vs. vancomycin vs. fidaxomicin) and hospitalization status (inpatient vs. outpatient).|Miettinen and Nurminen||Adjusted Difference: MK-3415A + SOC - Placebo + SOC|||10.4|-3.5|0.1646
72484369|NCT01241552|144495959|SUPERIORITY_OR_OTHER||Adjusted Difference|11.7||||0.0025|TWO_SIDED|95.0|3.5|19.7||One sided p-value based on the Miettinen and Nurminen method stratified by SOC therapy (metronidazole vs. vancomycin vs. fidaxomicin) and hospitalization status (inpatient vs. outpatient).|Miettinen and Nurminen||Adjusted Difference: MK-3415A + SOC - MK-3415 + SOC|||19.7|3.5|0.0025
72484370|NCT01241552|144495959|SUPERIORITY_OR_OTHER||Adjusted Difference|-1.4||||0.6532|TWO_SIDED|95.0|-8.3|5.5||One sided p-value based on the Miettinen and Nurminen method stratified by SOC therapy (metronidazole vs. vancomycin vs. fidaxomicin) and hospitalization status (inpatient vs. outpatient).|Miettinen and Nurminen||Adjusted Difference: MK-3415A + SOC - MK-6072 + SOC|||5.5|-8.3|0.6532
72484371|NCT01241552|144495960|SUPERIORITY_OR_OTHER||Adjusted Difference|1.7||||0.6505|TWO_SIDED|95.0|-6.9|10.7||One sided p-value based on the Miettinen and Nurminen method stratified by SOC therapy (metronidazole vs. vancomycin vs. fidaxomicin) and hospitalization status (inpatient vs. outpatient).|Miettinen and Nurminen||Adjusted Difference: MK-3415 + SOC - Placebo + SOC|||10.7|-6.9|0.6505
72484372|NCT01241552|144495960|SUPERIORITY_OR_OTHER||Adjusted Difference|-10.8||||0.0013|TWO_SIDED|95.0|-17.7|-3.8||One sided p-value based on the Miettinen and Nurminen method stratified by SOC therapy (metronidazole vs. vancomycin vs. fidaxomicin) and hospitalization status (inpatient vs. outpatient).|Miettinen and Nurminen||Adjusted Difference: MK-6072 + SOC - Placebo + SOC|||-3.8|-17.7|0.0013
72484373|NCT01241552|144495960|SUPERIORITY_OR_OTHER||Adjusted Difference|-11.7||||0.0006|TWO_SIDED|95.0|-18.6|-4.7||One sided p-value based on the Miettinen and Nurminen method stratified by SOC therapy (metronidazole vs. vancomycin vs. fidaxomicin) and hospitalization status (inpatient vs. outpatient).|Miettinen and Nurminen||Adjusted Difference: MK-3415A + SOC - Placebo + SOC|||-4.7|-18.6|0.0006
72484374|NCT01241552|144495960|SUPERIORITY_OR_OTHER||Adjusted Difference|-13.7||||0.0007|TWO_SIDED|95.0|-22.5|-5.2||One sided p-value based on the Miettinen and Nurminen method stratified by SOC therapy (metronidazole vs. vancomycin vs. fidaxomicin) and hospitalization status (inpatient vs. outpatient).|Miettinen and Nurminen||Adjusted Difference: MK-3415A + SOC - MK-3415 + SOC|||-5.2|-22.5|0.0007
72484375|NCT01241552|144495960|SUPERIORITY_OR_OTHER||Adjusted Difference|-1.0||||0.3906|TWO_SIDED|95.0|-7.7|5.8||One sided p-value based on the Miettinen and Nurminen method stratified by SOC therapy (metronidazole vs. vancomycin vs. fidaxomicin) and hospitalization status (inpatient vs. outpatient).|Miettinen and Nurminen||Adjusted Difference: MK-3415A + SOC - MK-6072 + SOC|||5.8|-7.7|0.3906
72484376|NCT01241552|144495961|SUPERIORITY_OR_OTHER||Percentage Difference|5.2||||0.185|TWO_SIDED|95.0|-2.5|12.8|||Miettinen and Nurminen||Percentage Difference: MK-3415 + SOC - Placebo + SOC|||12.8|-2.5|0.185
72484377|NCT01241552|144495961|SUPERIORITY_OR_OTHER||Percentage Difference|3.4||||0.323|TWO_SIDED|95.0|-3.3|10.1|||Miettinen and Nurminen||Percentage Difference: MK-6072 + SOC - Placebo + SOC|||10.1|-3.3|0.323
72484378|NCT01241552|144495961|SUPERIORITY_OR_OTHER||Percentage Difference|-2.3||||0.507|TWO_SIDED|95.0|-9.1|4.5|||Miettinen and Nurminen||Percentage Difference: MK-3415A + SOC - Placebo + SOC|||4.5|-9.1|0.507
72484379|NCT01241552|144495962|SUPERIORITY_OR_OTHER||Percentage Difference|2.2||||0.246|TWO_SIDED|95.0|-1.5|6.7|||Miettinen and Nurminen||Percentage Difference: MK-3415 + SOC - Placebo + SOC|||6.7|-1.5|0.246
72484380|NCT01241552|144495962|SUPERIORITY_OR_OTHER||Percentage Difference|3.2||||0.069|TWO_SIDED|95.0|-0.3|6.8|||Miettinen and Nurminen||Percentage Difference: MK-6072 + SOC - Placebo + SOC|||6.8|-0.3|0.069
72484381|NCT01241552|144495962|SUPERIORITY_OR_OTHER||Percentage Difference|1.2||||0.464|TWO_SIDED|95.0|-2.1|4.6|||Miettinen and Nurminen||Percentage Difference: MK-3415A + SOC - Placebo + SOC|||4.6|-2.1|0.464
72484382|NCT01241552|144495963|SUPERIORITY_OR_OTHER||Percentage Difference|7.7||||0.027|TWO_SIDED|95.0|0.9|14.7|||Miettinen and Nurminen||Percentage Difference: MK-3415 + SOC - Placebo + SOC|||14.7|0.9|0.027
72484383|NCT01241552|144495963|SUPERIORITY_OR_OTHER||Percentage Difference|1.5||||0.594|TWO_SIDED|95.0|-4.1|7.2|||Miettinen and Nurminen||Percentage Difference: MK-6072 + SOC - Placebo + SOC|||7.2|-4.1|0.594
72484384|NCT01241552|144495963|SUPERIORITY_OR_OTHER||Percentage Difference|-5.3||||0.051|TWO_SIDED|95.0|-10.6|0.0|||Miettinen and Nurminen||Percentage Difference: MK-3415A + SOC - Placebo + SOC|||0.0|-10.6|0.051
72542470|NCT00106028|144614689|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.065||||0.5925|TWO_SIDED|95.0|-2.868|4.998|||ANCOVA|LS means and p-value are from ANCOVA model adjusted by baseline and fixed effects for age group, treatment and pooled center for post-baseline.||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.||4.998|-2.868|0.5925
72484385|NCT01241552|144495964|SUPERIORITY_OR_OTHER||Percentage Difference|1.0||||0.115|TWO_SIDED|95.0|-0.3|3.5|||Miettinen and Nurminen||Percentage Difference: MK-3415 + SOC - Placebo + SOC|||3.5|-0.3|0.115
72484386|NCT01241552|144495964|SUPERIORITY_OR_OTHER||Percentage Difference|0.8||||0.17|TWO_SIDED|95.0|-0.5|2.4|||Miettinen and Nurminen||Percentage Difference: MK-6072 + SOC - Placebo + SOC|||2.4|-0.5|0.170
72484387|NCT01241552|144495964|SUPERIORITY_OR_OTHER||Percentage Difference|0.3||||0.544|TWO_SIDED|95.0|-0.9|1.6|||Miettinen and Nurminen||Percentage Difference: MK-3415A + SOC - Placeb + SOC|||1.6|-0.9|0.544
72484388|NCT01241552|144495965|SUPERIORITY_OR_OTHER||Percentage Difference|0.4||||0.192|TWO_SIDED|95.0|-0.5|2.4|||Miettinen and Nurminen||Percentage Difference: MK-3415 + SOC - Placebo + SOC|||2.4|-0.5|0.192
72484389|NCT01241552|144495965|SUPERIORITY_OR_OTHER||Percentage Difference|0.3||||0.311|TWO_SIDED|95.0|-0.7|1.4|||Miettinen and Nurminen||Percentage Difference: MK-6072 + SOC - Placebo + SOC|||1.4|-0.7|0.311
72484390|NCT01241552|144495965|SUPERIORITY_OR_OTHER||Percentage Difference|0.0|||>|0.999|TWO_SIDED|95.0|-1.0|1.0|||Miettinen and Nurminen||Percentage Difference: MK-3415A + SOC - Placebo + SOC|||1.0|-1.0|> 0.999
72484391|NCT01241552|144495966|SUPERIORITY_OR_OTHER||Percentage Difference|3.6|||||TWO_SIDED|95.0|-1.0|8.7|||||Percentage Difference: MK-3415 + SOC - Placebo + SOC|||8.7|-1.0|
72484392|NCT01241552|144495966|SUPERIORITY_OR_OTHER||Percentage Difference|4.3|||||TWO_SIDED|95.0|0.2|8.5|||||Percentage Difference: MK-6072 + SOC - Placebo + SOC|||8.5|0.2|
72484393|NCT01241552|144495966|SUPERIORITY_OR_OTHER||Percentage Difference|1.3|||||TWO_SIDED|95.0|-2.6|5.2|||||Percentage Difference: MK-3415A + SOC - Placebo + SOC|||5.2|-2.6|
72484394|NCT01241552|144495967|SUPERIORITY_OR_OTHER||Percentage Difference|-6.9|||||TWO_SIDED|95.0|-16.8|3.5|||||Percentage Difference: MK-3415 + SOC - Placebo + SOC|||3.5|-16.8|
72542471|NCT00106028|144614690|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.193||||0.684|TWO_SIDED|95.0|-4.604|6.991|||ANCOVA|LS means and p-value are from ANCOVA model adjusted by baseline and fixed effects for age group, treatment and pooled center for post-baseline.||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.||6.991|-4.604|0.6840
72542472|NCT00106028|144614691|SUPERIORITY_OR_OTHER|||||||0.068||95.0|||||Fisher Exact|||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.||||0.0680
72512108|NCT00755846|144554251|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.2|STANDARD_ERROR_OF_MEAN|7.37||0.01||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline fasting fructosamine as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in fasting fructosamine. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.010
72512109|NCT00755846|144554251|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-23.8|STANDARD_ERROR_OF_MEAN|7.71||0.002||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline fasting fructosamine as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in fasting fructosamine. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.002
72512110|NCT00755846|144554251|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-22.1|STANDARD_ERROR_OF_MEAN|7.33||0.003||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline fasting fructosamine as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in fasting fructosamine. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.003
72512111|NCT00755846|144554251|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-20.7|STANDARD_ERROR_OF_MEAN|7.44||0.006||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline fasting fructosamine as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in fasting fructosamine. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.006
72512112|NCT00755846|144554251|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.7|STANDARD_ERROR_OF_MEAN|7.45||0.117||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline fasting fructosamine as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in fasting fructosamine. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.117
72576870|NCT00261443|144680664|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.33||||0.073|TWO_SIDED|95.0|-0.69|0.03||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 52 Comparison||0.03|-0.69|0.073
72484395|NCT01241552|144495967|SUPERIORITY_OR_OTHER||Percentage Difference|-18.0|||||TWO_SIDED|95.0|-26.3|-9.6|||||Percentage Difference: MK-6072 + SOC - Placebo + SOC|||-9.6|-26.3|
72484396|NCT01241552|144495967|SUPERIORITY_OR_OTHER||Percentage Difference|-16.2|||||TWO_SIDED|95.0|-24.5|-7.7|||||Percentage Difference: MK-3415A + SOC - Placebo + SOC|||-7.7|-24.5|
72484397|NCT01241552|144495968|SUPERIORITY_OR_OTHER||Percentage Difference|-6.1|||||TWO_SIDED|95.0|-20.1|8.6|||||Percentage Difference: MK-3415 + SOC - Placebo + SOC|||8.6|-20.1|
72484398|NCT01241552|144495968|SUPERIORITY_OR_OTHER||Percentage Difference|-13.2|||||TWO_SIDED|95.0|-25.5|-0.5|||||Percentage Difference: MK-6072 + SOC - Placebo + SOC|||-0.5|-25.5|
72484399|NCT01241552|144495968|SUPERIORITY_OR_OTHER||Percentage Difference|-14.4|||||TWO_SIDED|95.0|-26.8|-1.6|||||Percentage Difference: MK-3415A + SOC - Placebo + SOC|||-1.6|-26.8|
72484400|NCT01241552|144495969|SUPERIORITY_OR_OTHER||Percentage Difference|0.8|||||TWO_SIDED|95.0|-16.9|21.0|||||Percentage Difference: MK-3415 + SOC - Placebo + SOC|||21.0|-16.9|
72484401|NCT01241552|144495969|SUPERIORITY_OR_OTHER||Percentage Difference|-14.6|||||TWO_SIDED|95.0|-28.3|-1.4|||||Percentage Difference: MK-6072 + SOC - Placebo + SOC|||-1.4|-28.3|
72484402|NCT01241552|144495969|SUPERIORITY_OR_OTHER||Percentage Difference|-12.1|||||TWO_SIDED|95.0|-26.2|1.9|||||Percentage Difference: MK-3415A + SOC - Placebo + SOC|||1.9|-26.2|
72484403|NCT01241552|144495970|SUPERIORITY_OR_OTHER||Percentage Difference|-10.0|||||TWO_SIDED|95.0|-30.1|10.0|||||Percentage Difference: MK-6072 + SOC - Placebo + SOC|||10.0|-30.1|
72484404|NCT01241552|144495970|SUPERIORITY_OR_OTHER||Percentage Difference|-25.3|||||TWO_SIDED|95.0|-43.7|-6.1|||||Percentage Difference: MK-3415A + SOC - Placebo + SOC|||-6.1|-43.7|
72484405|NCT01241552|144495971|SUPERIORITY_OR_OTHER||Percentage Difference|-11.3|||||TWO_SIDED|95.0|-24.9|3.9|||||Percentage Difference: MK-3415 + SOC - Placebo + SOC|||3.9|-24.9|
72484406|NCT01241552|144495971|SUPERIORITY_OR_OTHER||Percentage Difference|-12.7|||||TWO_SIDED|95.0|-24.7|-0.5|||||Percentage Difference: MK-6072 + SOC - Placebo + SOC|||-0.5|-24.7|
72484407|NCT01241552|144495971|SUPERIORITY_OR_OTHER||Percentage Difference|-16.0|||||TWO_SIDED|95.0|-27.8|-4.0|||||Percentage Difference: MK-3415A + SOC - Placebo + SOC|||-4.0|-27.8|
72484408|NCT01241552|144495972|SUPERIORITY_OR_OTHER||Percentage Difference|-10.1|||||TWO_SIDED|95.0|-23.2|4.6|||||Percentage Difference: MK-3415 + SOC - Placebo + SOC|||4.6|-23.2|
72484409|NCT01241552|144495972|SUPERIORITY_OR_OTHER||Percentage Difference|-11.0|||||TWO_SIDED|95.0|-23.2|1.4|||||Percentage Difference: MK-6072 + SOC - Placebo + SOC|||1.4|-23.2|
72624083|NCT05293314|144778519|OTHER|Evaluate the ability of the breath test model to distinguish bronchiectasis from healthy individuals by measuring the area under the receiver operating characteristic (ROC) curves. The maximum value in the area below the receiver is 1. The closer the value is to 1, the higher the prediction accuracy of the model.|receiver operating characteristic|0.964|||<|0.05|TWO_SIDED|95.0|0.932|0.996|||Wilcoxon (Mann-Whitney)|||Evaluate the ability of the breath test model to distinguish bronchiectasis from healthy individuals by measuring the area under the receiver operating characteristic (ROC) curves. The maximum value in the area below the receiver is 1. The closer the value is to 1, the higher the prediction accuracy of the model.||0.996|0.932|<0.05
72624084|NCT05293314|144778519|OTHER|Evaluate the ability of the breath test model to distinguish bronchiectasis from healthy individuals by measuring the area under the receiver operating characteristic (ROC) curves. The maximum value in the area below the receiver is 1. The closer the value is to 1, the higher the prediction accuracy of the model.|receiver operating characteristic|0.932|||<|0.05|TWO_SIDED|95.0|0.879|0.982|||Wilcoxon (Mann-Whitney)|||Evaluate the ability of the breath test model to distinguish bronchiectasis from healthy individuals by measuring the area under the receiver operating characteristic (ROC) curves. The maximum value in the area below the receiver is 1. The closer the value is to 1, the higher the prediction accuracy of the model.||0.982|0.879|<0.05
72402433|NCT01480076|144311679|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 3, PPMS. Mixed effect model for repeated measures with visit, baseline MSIS-29 psychological score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
72542473|NCT00106028|144614692|SUPERIORITY_OR_OTHER|||||||0.4121||95.0|||||Fisher Exact|||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.||||0.4121
72542474|NCT00106028|144614693|SUPERIORITY_OR_OTHER|||||||0.3658||95.0|||||Savage Exact Test|||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.||||0.3658
72542475|NCT00106028|144614694|SUPERIORITY_OR_OTHER|||||||0.3408||95.0|||||Savage Exact Test|||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.||||0.3408
72542476|NCT00106028|144614697|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.534||||0.0253||95.0|0.31|0.922||All Fractures|Cox proportional hazards|Hazard Ratio and 95% CI based on Cox proportional hazards model stratified by age group with treatment and pooled-country as covariates.||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.||0.922|0.310|0.0253
72542477|NCT00106028|144614697|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.534||||0.0253|TWO_SIDED|95.0|0.31|0.922||All Non-Vertebral Fractures|Cox Proportional Hazard|Hazard Ratio and 95% CI based on Cox proportional hazards model stratified by age group with treatment and pooled-country as covariates.||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.||0.922|0.310|0.0253
72542478|NCT00106028|144614697|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.487||||0.0501|TWO_SIDED|95.0|0.25|0.95||Long Bone Non-Vertebral Fracture|Cox Proportional Hazards|Hazard Ratio and 95% CI based on Cox proportional hazards model stratified by age group with treatment and pooled-country as covariates.||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.||0.950|0.250|0.0501
72542479|NCT00106028|144614697|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.608||||0.2141|TWO_SIDED|95.0|0.262|1.41||Other Non-Vertebral Fracture|Cox Proportional Hazard|Hazard Ratio and 95% CI based on Cox proportional hazards model stratified by age group with treatment and pooled-country as covariates.||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.||1.410|0.262|0.2141
72542480|NCT00106028|144614698|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.584||||0.0416||95.0|0.348|0.98||All Fractures|Wald test|Hazard Ratio and 95% CI based on Anderson-Gill mean intensity model stratified by age group with treatment and pooled-country as covariates.||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.||0.980|0.348|0.0416
72567367|NCT00518882|144665595|SUPERIORITY_OR_OTHER||Estimated treatment difference, LS Mean|-0.02||||0.1119||95.0|-0.05|0.01||There were no multiplicity concerns.|ANCOVA|||ANCOVA model included treatment, country and previous treatment as fixed effects and baseline value of the endpoint as covariate. The objective was to demonstrate that treatment with liraglutide was different from treatment with exenatide. Thus the null hypothesis and its alternative were H0: µliraglutide = µexenatide against HA1:µliraglutide ≠ µexenatide where µliraglutide and µexenatide is the mean value of the endpoint in the liraglutide arm and exenatide arm, respectively.||0.01|-0.05|0.1119
72576871|NCT00261443|144680665|SUPERIORITY_OR_OTHER_LEGACY||Ratio of Remission Rate|1.0||||0.91|TWO_SIDED|95.0|0.92|1.08||Cochran-Mantel-Haenszel General Association Test controlling for mood stabilizer and index mood episode.|Cochran-Mantel-Haenszel||Aripiprazole/Placebo|Week 4||1.08|0.92|0.910
72484410|NCT01241552|144495972|SUPERIORITY_OR_OTHER||Percentage Difference|-16.7|||||TWO_SIDED|95.0|-28.4|-4.7|||||Percentage Difference: MK-3415A + SOC - Placebo + SOC|||-4.7|-28.4|
72484411|NCT04464265|144495973|OTHER|Our study adopted a within-subject design, which is not a randomized controlled trial (RCT). The P-value below indicates if propofol administration has a statistically significant impact on the brain activity in response to sensory stimuli.|Mean Difference (Net)|-3.0|STANDARD_DEVIATION|2.0|<|0.001|TWO_SIDED|||||The threshold for statistical significance was p=0.05. The p-value was not adjusted for multiple comparisons, as only one comparison was performed.|t-test, 2 sided||Difference = BOLD Response During Sedation - BOLD Response During Baseline|The null hypothesis is no difference in BOLD response between sedated state and baseline. For an fMRI study of cognitive function, Desmond and Glover (J. Neurosci. Methods., 2002) reported that about 25 subjects are necessary to achieve 80% power for a 0.5% increase of activity. We analyzed 27 subjects that fulfilled the suggested optimal group size for reliable statistics in functional MRI studies (also see Thirion et al., Neuroimage, 2007).||||<0.001
72484412|NCT04464265|144495974|OTHER|Our study adopted a within-subject design, which is not a randomized controlled trial (RCT). The P-value below indicates if propofol administration has a statistically significant impact on the brain activity in response to sensory stimuli.|Mean Difference (Net)|-2.72|STANDARD_DEVIATION|3.17|<|0.001|TWO_SIDED|||||The threshold for statistical significance was p=0.05. The p-value was not adjusted for multiple comparisons, as only one comparison was performed.|t-test, 2 sided||Difference = Squeeze Pressure During Sedation - Squeeze Pressure During Baseline|||||<0.001
72484413|NCT02178553|144496004|NON_INFERIORITY|We determined that a difference of 1 unit between groups would be the bound for non-inferiorty.|Confidence Interval|1.0||||0.142|TWO_SIDED|90.0|-0.1|1.8|||t-test, 2 sided|||||1.8|-0.1|0.142
72484414|NCT02178553|144496005|NON_INFERIORITY|We determined that a difference of 1 unit between groups would be the bound for non-inferiorty.|Confidence Interval|1.0||||0.101|TWO_SIDED|90.0|0.4|1.9|||t-test, 2 sided|||||1.9|0.4|0.101
72484415|NCT02178553|144496006|NON_INFERIORITY|We determined that a difference of 1 unit between groups would be the bound for non-inferiorty.|Confidence Interval|1.0||||0.014|TWO_SIDED|90.0|0.4|1.9|||t-test, 2 sided|||||1.9|0.4|0.014
72484416|NCT02178553|144496007|NON_INFERIORITY|We determined that a difference of 1 unit between groups would be the bound for non-inferiorty.|Confidence Interval|1.0||||0.375|TWO_SIDED|90.0|-0.3|1.0|||t-test, 2 sided|||||1.0|-0.3|0.375
72484417|NCT01807923|144496026|SUPERIORITY_OR_OTHER||Least Squares (LS) Mean Difference|4.03|||<|0.0001|TWO_SIDED|95.0|2.62|5.44|||MMRM|||Analysis was performed using mixed-effects model for repeated measures (MMRM) model including treatment, visit, and treatment-by-visit interaction as fixed effects with adjustments for sex (male versus female), age group at baseline (less than (\<)18 versus greater than equal to (\>=18) years old), and percent predicted FEV1 severity at Screening (\<70 versus \>=70).||5.44|2.62|<0.0001
72484418|NCT01807923|144496026|SUPERIORITY_OR_OTHER||LS Mean Difference|2.6||||0.0003|TWO_SIDED|95.0|1.18|4.01|||MMRM|||Analysis was performed using MMRM model, as described in Statistical Analysis 1.||4.01|1.18|0.0003
72484419|NCT01807923|144496027|SUPERIORITY_OR_OTHER||LS Mean Difference|6.73|||<|0.0001|TWO_SIDED|95.0|4.27|9.19|||MMRM|||Analysis was performed using MMRM model including treatment, visit, and treatment-by-visit interaction as fixed effects with adjustments for sex (male versus female), age group at baseline (\<18 versus \>=18 years old), and percent predicted FEV1 severity at Screening (\<70 versus \>=70).||9.19|4.27|<0.0001
72484420|NCT01807923|144496027|SUPERIORITY_OR_OTHER||LS Mean Difference|4.33||||0.0006|TWO_SIDED|95.0|1.86|6.8|||MMRM|||Analysis was performed using MMRM model, as described in Statistical Analysis 1.||6.80|1.86|0.0006
72484421|NCT01807923|144496028|SUPERIORITY_OR_OTHER||LS Mean Difference|0.16||||0.1122|TWO_SIDED|95.0|-0.04|0.35|||MMRM|||Analysis was performed using MMRM model including treatment, visit, and treatment-by-visit interaction as fixed effects with adjustments for sex (male versus female), age group at baseline (\<18 versus \>=18 years old), percent predicted FEV1 severity at Screening (\<70 versus \>=70), and baseline BMI.||0.35|-0.04|0.1122
72484422|NCT01807923|144496028|SUPERIORITY_OR_OTHER||LS Mean Difference|0.13||||0.1938|TWO_SIDED|95.0|-0.07|0.32|||MMRM|||Analysis was performed using MMRM model, as described in Statistical Analysis 1.||0.32|-0.07|0.1938
72484423|NCT01807923|144496029|SUPERIORITY_OR_OTHER||LS Mean Difference|3.88||||0.0168|TWO_SIDED|95.0|0.7|7.05||This test is considered nominally significant because a hierarchical procedure was used and was broken prior to this test.|MMRM|||Analysis was performed using MMRM model including treatment, visit, and treatment-by-visit interaction as fixed effects with adjustments for sex (male versus female), age group at baseline (\<18 versus \>=18 years old), percent predicted FEV1 severity at Screening (\<70 versus \>=70), and baseline CFQ-R respiratory domain score.||7.05|0.70|0.0168
72484424|NCT01807923|144496029|SUPERIORITY_OR_OTHER||LS Mean Difference|1.5||||0.3569|TWO_SIDED|95.0|-1.69|4.69|||MMRM|||Analysis was performed using MMRM model, as described in Statistical Analysis 1.||4.69|-1.69|0.3569
72484425|NCT01807923|144496030|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.9378|||<|0.0001|TWO_SIDED|95.0|1.8786|4.5941||This test is considered nominally significant because a hierarchical procedure was used and was broken prior to this test.|Cochran-Mantel-Haenszel|||Odds Ratio (OR) and 95% confidence intervals (Cis) are Mantel-Haenszel estimates. P values are from a Cochran-Mantel-Haenszel test stratified by sex (male versus female), age group at baseline (\<18 versus \>=18 years old), and percent predicted FEV1 severity at Screening (\<70 versus \>=70).||4.5941|1.8786|<0.0001
72576872|NCT00261443|144680665|SUPERIORITY_OR_OTHER_LEGACY||Ratio of Remission Rate|1.04||||0.3|TWO_SIDED|95.0|0.97|1.11||Cochran-Mantel-Haenszel General Association Test controlling for mood stabilizer and index mood episode.|Cochran-Mantel-Haenszel||Aripiprazole/Placebo|Week 8||1.11|0.97|0.300
72512113|NCT00755846|144554252|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.3|STANDARD_ERROR_OF_MEAN|6.6||0.014||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline fasting fructosamine as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in fasting fructosamine. The treatment effect will be evaluated as a contrast of all doses of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.014
72512114|NCT00755846|144554252|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.5|STANDARD_ERROR_OF_MEAN|8.35||0.136||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline fasting fructosamine as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in fasting fructosamine. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.136
72484426|NCT01807923|144496030|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.0592||||0.0023|TWO_SIDED|95.0|1.292|3.2819||This test is considered nominally significant because a hierarchical procedure was used and was broken prior to this test.|Cochran-Mantel-Haenszel|||Analysis was performed as described in Statistical Analysis 1.||3.2819|1.2920|0.0023
72484427|NCT01807923|144496031|SUPERIORITY_OR_OTHER||Event Rate Ratio|0.7186||||0.0491|TWO_SIDED|95.0|0.517|0.9987|||Negative Binomial Regression|||Analysis was performed using regression analysis for a negative binomial distribution with sex (male versus female), age group at baseline (\<18 versus \>=18 years old), and percent predicted FEV1 severity at Screening (\<70 versus \>=70) as covariates with the logarithm of time on study as the offset.||0.9987|0.5170|0.0491
72512115|NCT00755846|144554252|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-20.1|STANDARD_ERROR_OF_MEAN|8.73||0.022||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline fasting fructosamine as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in fasting fructosamine. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.022
72567368|NCT00518882|144665596|SUPERIORITY_OR_OTHER||Mean|-0.02|STANDARD_DEVIATION|0.168||0.1342||95.0|-0.041|0.006|||Paired t test|||A paired t test was made within the group and 95% confidence intervals for the difference between Weeks 26 and 78 were constructed. H0 was µ78 - µ26 = 0 against HA: µ78 - µ26 ≠ 0. A difference between the two means (Week 26 and Week 78) was concluded when H0 was rejected at the 5% level.||0.006|-0.041|0.1342
72484428|NCT01807923|144496031|SUPERIORITY_OR_OTHER||Event Rate Ratio|0.6643||||0.0169|TWO_SIDED|95.0|0.4749|0.9291||This test is considered nominally significant because a hierarchical procedure was used and was broken prior to this test.|Negative Binomial Regression|||Analysis was performed as described in Statistical Analysis 1.||0.9291|0.4749|0.0169
72484429|NCT01807923|144496032|SUPERIORITY_OR_OTHER||LS Mean Difference|0.4||||0.1565|TWO_SIDED|95.0|-0.16|0.96|||MMRM|||Analysis was performed using MMRM model including treatment, visit, and treatment-by-visit interaction as fixed effects with adjustments for sex (male versus female), age group at baseline (\<18 versus \>=18 years old), percent predicted FEV1 severity at Screening (\<70 versus \>=70), and baseline weight.||0.96|-0.16|0.1565
72484430|NCT01807923|144496032|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3||||0.2992|TWO_SIDED|95.0|-0.26|0.86|||MMRM|||Analysis was performed as described in Statistical Analysis 1.||0.86|-0.26|0.2992
72484431|NCT01807923|144496033|SUPERIORITY_OR_OTHER||LS Mean Difference|0.098||||0.1539|TWO_SIDED|95.0|-0.037|0.233|||MMRM|||Analysis was performed using MMRM model including treatment, visit, and treatment-by-visit interaction as fixed effects with adjustments for sex (male versus female), age group at baseline (\<18 versus \>=18 years old), percent predicted FEV1 severity at Screening (\<70 versus \>=70), and baseline BMI z-score.||0.2330|-0.0370|0.1539
72567369|NCT00518882|144665596|SUPERIORITY_OR_OTHER||Mean|-0.03|STANDARD_DEVIATION|0.189||0.0344||95.0|-0.057|-0.002|||Paired t test|||A paired t test was made within the treatment group and 95% confidence intervals for the difference between Weeks 26 and 78 were constructed. H0 was µ78 - µ26 = 0 against HA: µ78 - µ26 ≠ 0. A difference between the two means (Week 26 and Week 78) was concluded when H0 was rejected at the 5% level.||-0.002|-0.057|0.0344
72567370|NCT00518882|144665597|SUPERIORITY_OR_OTHER||Mean|-0.08|STANDARD_DEVIATION|0.176|<|0.0001||95.0|-0.105|-0.056|||Paired t test|||The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 0 and 78 were constructed. H0 was µ78- µ0=0 against HA: µ78 - µ0 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.||-0.056|-0.105|<0.0001
72567371|NCT00518882|144665597|SUPERIORITY_OR_OTHER||Mean|-0.07|STANDARD_DEVIATION|0.192|<|0.0001||95.0|-0.094|-0.038|||Paired t test|||The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 0 and 78 were constructed. H0 was µ78- µ0=0 against HA: µ78 - µ0 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.||-0.038|-0.094|<0.0001
72567372|NCT03395639|144665600|OTHER|Difference in adjudicated major or CRNM bleeding rates were assessed.|Annualized rate difference|-0.03|||||TWO_SIDED|95.0|-0.18|0.12||||||||0.12|-0.18|
72567373|NCT03395639|144665600|OTHER|Difference in adjudicated major bleeding rates were assessed.|Annualized rate difference|0.0|||||TWO_SIDED|95.0|0.0|0.0||||||||0|0|
72567374|NCT03395639|144665600|OTHER|Difference in all adjudicated bleeding (major, CRNM, minor) rates were assessed.|Annualized rate difference|0.0|||||TWO_SIDED|95.0|-0.24|0.25||||||||0.25|-0.24|
72567375|NCT00942331|144665608|SUPERIORITY||Hazard Ratio (HR)|0.87||||0.1707|TWO_SIDED|95.0|0.72|1.06|||Log Rank|Stratified log rank||||1.06|0.72|0.1707
72484432|NCT01807923|144496033|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0781||||0.2713|TWO_SIDED|95.0|-0.0615|0.2176|||MMRM|||Analysis was performed as described in Statistical Analysis 1.||0.2176|-0.0615|0.2713
72567376|NCT02696031|144665636|SUPERIORITY||Odds Ratio (OR)|1.72||||0.0197|TWO_SIDED|95.0|1.09|2.7||unadjusted p-value|Regression, Logistic|||week 16||2.70|1.09|0.0197
72484433|NCT01807923|144496034|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.692||||0.0396|TWO_SIDED||||||Cox Proportional Hazard Regression|||Analysis was performed using Cox proportional hazard regression, time is the time-to-first event or censoring, with adjustment for sex (male versus female), age group at baseline (\<18 versus \>=18 years old), and percent predicted FEV1 severity at Screening (\<70 versus \>=70).||||0.0396
72484434|NCT01807923|144496034|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.691||||0.0385|TWO_SIDED||||||Cox Proportional Hazard Regression|||Analysis was performed as described in Statistical Analysis 1.||||0.0385
72484435|NCT01807923|144496035|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.6565||||0.0552|TWO_SIDED|95.0|0.4266|1.0103|||Cochran-Mantel-Haenszel|||OR and 95% confidence intervals (CIs) are Mantel-Haenszel estimates. P values are from a Cochran-Mantel-Haenszel test stratified by sex (male versus female), age group at baseline (\<18 versus \>=18 years old), and percent predicted FEV1 severity at Screening (\<70 versus \>=70).||1.0103|0.4266|0.0552
72484436|NCT01807923|144496035|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.6438||||0.0512|TWO_SIDED|95.0|0.4142|1.0005|||Cochran-Mantel-Haenszel|||Analysis was performed as described in Statistical Analysis 1.||1.0005|0.4142|0.0512
72484437|NCT01807923|144496036|SUPERIORITY_OR_OTHER||LS Mean Difference|0.006||||0.5604|TWO_SIDED|95.0|-0.0142|0.0262|||MMRM|||Analysis was performed using MMRM model including treatment, visit, and treatment-by-visit interaction as fixed effects with adjustments for sex (male versus female), age group at baseline (\<18 versus \>=18 years old), percent predicted FEV1 severity at Screening (\<70 versus \>=70), and baseline EQ-5D-3L index score.||0.0262|-0.0142|0.5604
72484438|NCT01807923|144496036|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0095||||0.3613|TWO_SIDED|95.0|-0.0109|0.0298|||MMRM|||Analysis was performed as described in Statistical Analysis 1.||0.0298|-0.0109|0.3613
72484439|NCT01807923|144496037|SUPERIORITY_OR_OTHER||LS Mean Difference|2.1||||0.1342|TWO_SIDED|95.0|-0.7|4.9|||MMRM|||Analysis was performed using MMRM model including treatment, visit, and treatment-by-visit interaction as fixed effects with adjustments for sex (male versus female), age group at baseline (\<18 versus \>=18 years old), percent predicted FEV1 severity at Screening (\<70 versus \>=70), and baseline EQ-5D-3L VAS score.||4.9|-0.7|0.1342
72484440|NCT01807923|144496037|SUPERIORITY_OR_OTHER||LS Mean Difference|1.4||||0.3071|TWO_SIDED|95.0|-1.3|4.2|||MMRM|||Analysis was performed as described in Statistical Analysis 1.||4.2|-1.3|0.3071
72484441|NCT01807923|144496038|SUPERIORITY_OR_OTHER||LS Mean Difference|5.49||||0.016|TWO_SIDED|95.0|1.03|9.96|||MMRM|||Effectiveness: analysis was performed using MMRM model including treatment, visit, and treatment-by-visit interaction as fixed effects with adjustments for sex (male versus female), age group at baseline (\<18 versus \>=18 years old), percent predicted FEV1 severity at Screening (\<70 versus \>=70), and baseline TSQM effectiveness score.||9.96|1.03|0.0160
72567377|NCT02696031|144665636|SUPERIORITY||Odds Ratio (OR)|1.76||||0.0146|TWO_SIDED|95.0|1.12|2.76||unadjusted p-value|Regression, Logistic|||week 16||2.76|1.12|0.0146
72567378|NCT02696031|144665637|SUPERIORITY||Odds Ratio (OR)|2.21||||0.0017|TWO_SIDED|95.0|1.35|3.63||unadjusted p-value|Regression, Logistic|||week 52||3.63|1.35|0.0017
72484442|NCT01807923|144496038|SUPERIORITY_OR_OTHER||LS Mean Difference|5.8||||0.0126|TWO_SIDED|95.0|1.25|10.35|||MMRM|||Effectiveness: analysis was performed as described in Statistical Analysis 1.||10.35|1.25|0.0126
72484443|NCT01807923|144496038|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.18||||0.0074|TWO_SIDED|95.0|-7.23|-1.13|||MMRM|||Side Effects: analysis was performed using MMRM model including treatment, visit, and treatment-by-visit interaction as fixed effects with adjustments for sex (male versus female), age group at baseline (\<18 versus \>=18 years old), percent predicted FEV1 severity at Screening (\<70 versus \>=70), and baseline TSQM side effects score.||-1.13|-7.23|0.0074
72484444|NCT01807923|144496038|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.74||||0.0029|TWO_SIDED|95.0|-7.85|-1.63|||MMRM|||Side Effects: analysis was performed as described in Statistical Analysis 1.||-1.63|-7.85|0.0029
72484445|NCT01807923|144496038|SUPERIORITY_OR_OTHER||LS Mean Difference|0.61||||0.7721|TWO_SIDED|95.0|-3.5|4.71|||MMRM|||Convenience: analysis was performed using MMRM model including treatment, visit, and treatment-by-visit interaction as fixed effects with adjustments for sex (male versus female), age group at baseline (\<18 versus \>=18 years old), percent predicted FEV1 severity at Screening (\<70 versus \>=70), and baseline TSQM convenience score.||4.71|-3.50|0.7721
72484446|NCT01807923|144496038|SUPERIORITY_OR_OTHER||LS Mean Difference|3.08||||0.1472|TWO_SIDED|95.0|-1.09|7.25|||MMRM|||Convenience: analysis was performed as described in Statistical Analysis 1.||7.25|-1.09|0.1472
72484447|NCT01807923|144496038|SUPERIORITY_OR_OTHER||LS Mean Difference|5.49||||0.0345|TWO_SIDED|95.0|0.4|10.58|||MMRM|||Global Satisfaction: analysis was performed using MMRM model including treatment, visit, and treatment-by-visit interaction as fixed effects with adjustments for sex (male versus female), age group at baseline (\<18 versus \>=18 years old), percent predicted FEV1 severity at Screening (\<70 versus \>=70), and baseline TSQM global satisfaction score.||10.58|0.40|0.0345
72484448|NCT01807923|144496038|SUPERIORITY_OR_OTHER||LS Mean Difference|6.72||||0.0109|TWO_SIDED|95.0|1.55|11.89|||MMRM|||Global Satisfaction: analysis was performed as described in Statistical Analysis 1.||11.89|1.55|0.0109
72484449|NCT02558231|144496052|SUPERIORITY||Ratio of geometric Least Square mean|0.96||||0.4239|TWO_SIDED|95.0|0.86|1.07|||ANCOVA|||||1.07|0.86|0.4239
72567379|NCT02696031|144665637|SUPERIORITY||Odds Ratio (OR)|2.67|||<|0.0001|TWO_SIDED|95.0|1.64|4.36||unadjusted p-value|Regression, Logistic|||week 52||4.36|1.64|<.0001
72484450|NCT02558231|144496053|SUPERIORITY||Least Square (LS) Mean difference|-1.43||||0.8758|TWO_SIDED|95.0|-19.393|16.538|||ANCOVA|||||16.538|-19.393|0.8758
72484451|NCT02558231|144496054|SUPERIORITY||Ratio of geometric LS mean|1.03||||0.8529|TWO_SIDED|95.0|0.77|1.371|||ANCOVA|||||1.371|0.770|0.8529
72484452|NCT02558231|144496056|SUPERIORITY||LS Mean Difference|-0.72||||0.4998|TWO_SIDED|95.0|-2.834|1.386|||ANCOVA|||||1.386|-2.834|0.4998
72484453|NCT02558231|144496057|SUPERIORITY||LS Mean Difference|-0.09||||0.8528|TWO_SIDED|95.0|-1.003|0.83|||ANCOVA|||||0.830|-1.003|0.8528
72567380|NCT02696031|144665638|SUPERIORITY||Odds Ratio (OR)|1.77||||0.0108|TWO_SIDED|95.0|1.14|2.74||unadjusted p-value|Regression, Logistic|||week 16|Odds ratio, 95% CI, and p-value were from a logistic regression model with treatment, stratification factor (CRP+/MRI+, CRP+/MRI-, CRP-/MRI+) and TNFi status as factors and baseline weight as a covariate.|2.74|1.14|0.0108
72567381|NCT02696031|144665638|SUPERIORITY||Odds Ratio (OR)|1.8||||0.0087|TWO_SIDED|95.0|1.16|2.78||unadjusted p-value|Regression, Logistic|||week 16|Odds ratio, 95% CI, and p-value were from a logistic regression model with treatment, stratification factor (CRP+/MRI+, CRP+/MRI-, CRP-/MRI+) and TNFi status as factors and baseline weight as a covariate.|2.78|1.16|0.0087
72567382|NCT02696031|144665638|SUPERIORITY|week 52|Odds Ratio (OR)|2.16||||0.0016|TWO_SIDED|95.0|1.34|3.49||unadjusted p-value|Regression, Linear||||Odds ratio, 95% CI, and p-value were from a logistic regression model with treatment, stratification factor (CRP+/MRI+, CRP+/MRI-, CRP-/MRI+) and TNFi status as factors and baseline weight as a covariate.|3.49|1.34|0.0016
72567383|NCT02696031|144665638|SUPERIORITY|week 52|Median Difference (Net)|2.61|||<|0.0001|TWO_SIDED|95.0|1.62|4.19||unadjusted p-value|Regression, Linear||||Odds ratio, 95% CI, and p-value were from a logistic regression model with treatment, stratification factor (CRP+/MRI+, CRP+/MRI-, CRP-/MRI+) and TNFi status as factors and baseline weight as a covariate.|4.19|1.62|<.0001
72567384|NCT02696031|144665639|SUPERIORITY||Odds Ratio (OR)|1.6||||0.026|TWO_SIDED|95.0|1.06|2.43||unadjusted p-value|Regression, Logistic|||week 16|Odds ratio, 95% CI, and p-value were from a logistic regression model with treatment, stratification factor (CRP+/MRI+, CRP+/MRI-, CRP-/MRI+) and TNFi status as factors and baseline weight as a covariate.|2.43|1.06|0.0260
72567385|NCT02696031|144665639|SUPERIORITY||Odds Ratio (OR)|1.68||||0.0149|TWO_SIDED|95.0|1.11|2.54||unadjusted p-value|Regression, Logistic|||week 16|Odds ratio, 95% CI, and p-value were from a logistic regression model with treatment, stratification factor (CRP+/MRI+, CRP+/MRI-, CRP-/MRI+) and TNFi status as factors and baseline weight as a covariate.|2.54|1.11|0.0149
72484454|NCT02558231|144496058|SUPERIORITY||LS Mean Difference|2.4||||0.9474|TWO_SIDED|95.0|-69.368|74.178|||ANCOVA|||||74.178|-69.368|0.9474
72484455|NCT02558231|144496059|SUPERIORITY||LS Mean Difference|0.13||||0.1902|TWO_SIDED|95.0|-0.066|0.328|||ANCOVA|||||0.328|-0.066|0.1902
72484456|NCT02558231|144496060|SUPERIORITY||LS Mean Difference|-1.2||||0.1227|TWO_SIDED|95.0|-2.737|0.327|||ANCOVA|||||0.327|-2.737|0.1227
72484457|NCT02558231|144496061|SUPERIORITY||Hazard Ratio (HR)|0.59||||0.0867|TWO_SIDED|95.0|0.32|1.09|||Log Rank|||||1.09|0.32|0.0867
72484458|NCT04029961|144496068|OTHER|Multivariate regression model and intra-arm differences in measure scores between time points.|||||<|0.05||||||Multivariate regression was adjusted for covariates of study site, highest education level, prior chemotherapy, age, \& T stage. Random effects was adjusted for multiple measurements. Multiplicity corrections were conducted via Holm-Sidak method.|multivariate regression|||||||<0.05
72484459|NCT04029961|144496069|OTHER|Multivariate regression model and intra-arm differences in measure scores between time points.|||||<|0.05||||||Multivariate regression was adjusted for covariates of study site, highest education level, prior chemotherapy, age, \& T stage. Random effects was adjusted for multiple measurements. Multiplicity corrections were conducted via Holm-Sidak method.|multivariate regression|||||||<0.05
72484460|NCT04029961|144496070|OTHER|Multivariate regression model and intra-arm differences in measure scores between time points.|||||<|0.05||||||Multivariate regression was adjusted for covariates of study site, highest education level, prior chemotherapy, age, \& T stage. Random effects was adjusted for multiple measurements. Multiplicity corrections were conducted via Holm-Sidak method.|multivariate regression|||||||<0.05
72484461|NCT04029961|144496071|OTHER|Multivariate regression model and intra-arm differences in measure scores between time points.|||||<|0.05||||||Multivariate regression was adjusted for covariates of study site, highest education level, prior chemotherapy, age, \& T stage. Random effects was adjusted for multiple measurements. Multiplicity corrections were conducted via Holm-Sidak method.|multivariate regression|||||||<0.05
72484462|NCT04029961|144496072|OTHER|"A univariate analysis comparing the proportion of each arm that indicated an item was met, evaluated for each item at each time point."|||||<|0.05|||||||Univariate analysis|||"The statistical test described below was only performed on the top 10 items on the scale rated the highest in importance by participants. The top 10 items were determined by computing the mean rating for each item (participants gave each item a rating from '1' - '9' with higher values representing greater importance) and selecting the 10 items with the largest mean values, excluding the item the radiation oncologist who will be treating me as that item was not addressed in either intervention."||||<0.05
72484463|NCT04252287|144496106|SUPERIORITY||LS mean difference|4.3||||0.016|TWO_SIDED|95.0|0.8|7.8|||ANCOVA|||||7.8|0.8|0.016
72512116|NCT00755846|144554252|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-24.1|STANDARD_ERROR_OF_MEAN|8.26||0.004||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline fasting fructosamine as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in fasting fructosamine. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.004
72567386|NCT02696031|144665640|SUPERIORITY||Odds Ratio (OR)|2.26||||0.0005|TWO_SIDED|95.0|1.43|3.58||unadjusted p-value|Regression, Logistic|||week 16|Odds ratio, 95% CI, and p-value were from a logistic regression model with treatment, stratification factor (CRP+/MRI+, CRP+/MRI-, CRP-/MRI+) and TNF-alpha status as factors and baseline weight as a covariate.|3.58|1.43|0.0005
72567387|NCT02696031|144665640|SUPERIORITY||Odds Ratio (OR)|1.85||||0.0094|TWO_SIDED|95.0|1.16|2.94||unadjusted p-value|Regression, Logistic|||week 16|Odds ratio, 95% CI, and p-value were from a logistic regression model with treatment, stratification factor (CRP+/MRI+, CRP+/MRI-, CRP-/MRI+) and TNF-alpha status as factors and baseline weight as a covariate.|2.94|1.16|0.0094
72567388|NCT02696031|144665641|SUPERIORITY||Odds Ratio (OR)|3.8|||<|0.0001|TWO_SIDED|95.0|1.95|7.39||unadjusted p-value|Regression, Logistic|||week 16|Odds ratio, 95% CI, and p-value were from a logistic regression model with treatment, stratification factor (CRP+/MRI+, CRP+/MRI-, CRP-/MRI+) and TNF-alpha status as factors and baseline weight as a covariate.|7.39|1.95|<.0001
72567389|NCT02696031|144665641|SUPERIORITY||Odds Ratio (OR)|3.64||||0.0001|TWO_SIDED|95.0|1.87|7.1||unadjusted p-value|Regression, Logistic|||week 16|Odds ratio, 95% CI, and p-value were from a logistic regression model with treatment, stratification factor (CRP+/MRI+, CRP+/MRI-, CRP-/MRI+) and TNF-alpha status as factors and baseline weight as a covariate.|7.10|1.87|0.0001
72512117|NCT00755846|144554252|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.5|STANDARD_ERROR_OF_MEAN|8.48||0.04||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline fasting fructosamine as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in fasting fructosamine. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.040
72484464|NCT04252287|144496107|SUPERIORITY||LS mean difference|29.8||||0.852|TWO_SIDED|95.0|-284.4|344.1|||ANCOVA|||||344.1|-284.4|0.852
72484465|NCT02273726|144496138|NON_INFERIORITY|Non-inferiority was established if the 2-sided 95% confidence interval (CI) for the treatment difference in least square (LS) means from MI ANCOVA model between the 2 treatment groups lay entirely above -0.75 g/dL.|LS Mean Difference|0.48|STANDARD_ERROR_OF_MEAN|0.058|<|0.0001|TWO_SIDED|95.0|0.365|0.591|||ANCOVA|ANCOVA with MI||Treatment comparison was made using the multiple imputation (MI) strategy by combining the results of analysis of covariance (ANCOVA) model with baseline Hb as a covariate, and treatment, ESA dependent incident dialysis within ≤4 months vs. \>4 months of starting dialysis when randomized, and other randomization stratification factors except mean qualifying screening hemoglobin (≤10.5 vs. \>10.5 g/dL) as fixed effects.||0.591|0.365|<0.0001
72512118|NCT00755846|144554252|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.5|STANDARD_ERROR_OF_MEAN|8.47||0.378||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline fasting fructosamine as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in fasting fructosamine. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.378
72512119|NCT00755846|144554253|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.9|STANDARD_ERROR_OF_MEAN|5.37||0.718||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline total cholesterol as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in total cholesterol. The treatment effect will be evaluated as a contrast of all doses of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.718
72484466|NCT02273726|144496139|NON_INFERIORITY|The non-inferiority was established when the 2-sided 95% CI for the difference of LS means between the 2 treatment groups using the MMRM model lay entirely above -0.75 g/dL.|LS Mean Difference|0.55|STANDARD_ERROR_OF_MEAN|0.072|<|0.0001|TWO_SIDED|95.0|0.404|0.687|||Mixed Models Analysis|||Treatment comparison was made using a mixed model of repeated measures (MMRM) with baseline Hb as a covariate, and treatment, visit, visit-by-treatment interaction, ESA dependent incident dialysis within ≤4 months vs. \>4 months of starting dialysis when randomized, and randomization stratification factors except mean qualifying screening Hb (≤10.5 vs. \>10.5 g/dL) as fixed effects.||0.687|0.404|<0.0001
72484467|NCT02273726|144496140|NON_INFERIORITY|Non-inferiority was established if the lower bound of the 2-sided 95% CI for the treatment difference for the responder rates (roxadustat minus epoetin alfa) calculated based on the Miettinen \& Nurminen approach, adjusting for stratification factors, was greater than -15%.|Responder Rate Difference|7.6|||||TWO_SIDED|95.0|0.9|14.3||||||For the difference of responder rates between 2 treatment groups, the CI analyzed was from the Miettinen \& Nurminen approach adjusting for randomization stratification factors.||14.3|0.9|
72484468|NCT02273726|144496141|NON_INFERIORITY|Non-inferiority was established if the lower bound of the 2-sided 95% CI for the treatment difference for the responder rates (roxadustat minus epoetin alfa) calculated based on the Miettinen \& Nurminen approach, adjusting for stratification factors, was greater than -15%.|Responder Rate Difference|2.7|||||TWO_SIDED|95.0|-4.3|9.7||||||For the difference of responder rates between 2 treatment groups, the CI analyzed was from the Miettinen \& Nurminen approach adjusting for randomization stratification factors.||9.7|-4.3|
72484469|NCT02273726|144496142|SUPERIORITY|Superiority was declared if the upper bound of the 2-sided 95% CI of the difference between roxadustat and epoetin alfa (roxadustat - epoetin alpha) was less than 0.|Least Square Mean Difference|-14.67|STANDARD_ERROR_OF_MEAN|1.514|<|0.0001|TWO_SIDED|95.0|-17.64|-11.695|||Mixed Models Analysis|||Treatment comparison was made using a MMRM with baseline as a covariate, and treatment, visit, visit-by-treatment interaction, ESA dependent incident dialysis within ≤4 months vs. \>4 months of starting dialysis when randomized, and randomization stratification factors as fixed effects.||-11.695|-17.640|<0.0001
72484470|NCT02273726|144496143|NON_INFERIORITY|The non-inferiority margin was fixed as a difference of -0.75.|LS Mean Difference|0.69|STANDARD_ERROR_OF_MEAN|0.093|<|0.0001|TWO_SIDED|95.0|0.503|0.869||Threshold for significance at 0.05 level.|ANCOVA|ANCOVA with MI||Treatment comparison was made using the MI strategy by combining the results of ANCOVA model with baseline Hb as a covariate, and treatment, ESA dependent incident dialysis within ≤4 months vs. \>4 months of starting dialysis when randomized, and other randomization stratification factors except mean qualifying screening Hb (≤10.5 vs. \>10.5 g/dL) as fixed effects.||0.869|0.503|<0.0001
72484471|NCT02273726|144496144|SUPERIORITY||LS Mean Difference|-20.14|STANDARD_ERROR_OF_MEAN|6.975||0.00091|TWO_SIDED|95.0|-33.842|-6.445||Threshold for significance at 0.05 level.|Rank ANCOVA|||Treatment comparison was made using an ANCOVA model with baseline iron repletion status, treatment, ESA dependent incident dialysis within ≤4 months vs. \>4 months of starting dialysis when randomized, and randomization stratification factors as fixed effects.||-6.445|-33.842|0.00091
72402434|NCT01480076|144311679|SUPERIORITY_OR_OTHER|||||||0.0021|||||||mixed effect model|||Month 3, PRMS. Mixed effect model for repeated measures with visit, baseline MSIS-29 psychological score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.0021
72402435|NCT01480076|144311679|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 6, RRMS. Mixed effect model for repeated measures with visit, baseline MSIS-29 psychological score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
72402436|NCT01480076|144311679|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 6, SPMS. Mixed effect model for repeated measures with visit, baseline MSIS-29 psychological score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
72402437|NCT01480076|144311679|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 6, PPMS. Mixed effect model for repeated measures with visit, baseline MSIS-29 psychological score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
72402438|NCT01480076|144311679|SUPERIORITY_OR_OTHER|||||||0.0097|||||||mixed effect model|||Month 6, PRMS. Mixed effect model for repeated measures with visit, baseline MSIS-29 psychological score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.0097
72567390|NCT02696031|144665642|SUPERIORITY||LS Mean|-0.75|STANDARD_ERROR_OF_MEAN|0.259||0.0041|TWO_SIDED|95.0|-1.26|-0.24||unadjusted p-value|MMRM|||week 16|LS Mean, 95% CI, and p-value were from a mixed model repeated measures (MMRM) with treatment group, analysis visit, stratification factor (CRP+/MRI+, CRP+/MRI-, CRP-/MRI+) and TNFi status as factors, weight and baseline score as covariates, treatment by analysis visit and baseline score by analysis visit as interaction terms, using an unstructured covariance structure.|-0.24|-1.26|0.0041
72567391|NCT02696031|144665642|SUPERIORITY||LS Mean|-0.64|STANDARD_ERROR_OF_MEAN|0.259||0.0143|TWO_SIDED|95.0|-1.15|-0.13||unadjusted p-value|MMRM|||week 16|LS Mean, 95% CI, and p-value were from a mixed model repeated measures (MMRM) with treatment group, analysis visit, stratification factor (CRP+/MRI+, CRP+/MRI-, CRP-/MRI+) and TNFi status as factors, weight and baseline score as covariates, treatment by analysis visit and baseline score by analysis visit as interaction terms, using an unstructured covariance structure.|-0.13|-1.15|0.0143
72402439|NCT01480076|144311679|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 9, RRMS. Mixed effect model for repeated measures with visit, baseline MSIS-29 psychological score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
72402440|NCT01480076|144311679|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 9, SPMS. Mixed effect model for repeated measures with visit, baseline MSIS-29 psychological score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
72402441|NCT01480076|144311679|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 9, PPMS. Mixed effect model for repeated measures with visit, baseline MSIS-29 psychological score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
72402442|NCT01480076|144311679|SUPERIORITY_OR_OTHER|||||||0.0103|||||||mixed effect model|||Month 9, PRMS. Mixed effect model for repeated measures with visit, baseline MSIS-29 psychological score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.0103
72484472|NCT02273726|144496145|NON_INFERIORITY|The non-inferiority margin for the difference between groups was 1.8.|Hazard Ratio (HR)|0.67||||0.0337|TWO_SIDED|95.0|0.466|0.97|||Cox Proportional Hazards model|||Analysis was done using a Cox Proportional Hazards model adjusting for baseline Hb and other stratification factors except mean qualifying screening Hb (≤10.5 vs. \>10.5 g/dL) as fixed effects.||0.970|0.466|0.0337
72484473|NCT02273726|144496146|SUPERIORITY|Superiority was declared if the upper bound of the 2-sided 95% CI of the difference between roxadustat and epoetin alfa (roxadustat - epoetin alpha) was less than 0.|LS Mean Difference|0.69|STANDARD_ERROR_OF_MEAN|0.739||0.35|TWO_SIDED|95.0|-0.76|2.142|||Mixed Models Analysis|||Treatment comparison was made using MMRM with baseline as a covariate, and treatment, visit, visit-by-treatment interaction, ESA dependent incident dialysis within ≤4 months vs. \>4 months of starting dialysis when randomized, and randomization stratification factors as fixed effects.||2.142|-0.760|0.3500
72512120|NCT00755846|144554253|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.4|STANDARD_ERROR_OF_MEAN|6.8||0.346||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline total cholesterol as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in total cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.346
72512121|NCT00755846|144554253|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9|STANDARD_ERROR_OF_MEAN|7.13||0.901||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline total cholesterol as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in total cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.901
72402443|NCT01480076|144311679|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 12, RRMS. Mixed effect model for repeated measures with visit, baseline MSIS-29 psychological score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
72402444|NCT01480076|144311679|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 12, SPMS. Mixed effect model for repeated measures with visit, baseline MSIS-29 psychological score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
72484474|NCT02877927|144496164|NON_INFERIORITY|A non-inferiority margin of 10% was used for the analysis.|treatment difference|5.0|||||TWO_SIDED|95.0|-0.2|10.3|||||The 95% confidence interval was constructed based on the Miettinen and Nurminen method without stratification. Treatment difference for a response of clinical success was calculated as omadacycline minus linezolid.|||10.3|-0.2|
72484475|NCT02877927|144496165|NON_INFERIORITY|A non-inferiority margin of 10% was used for the analysis.|treatment difference|3.3|||||TWO_SIDED|95.0|-2.2|8.9|||||The 95% confidence interval was constructed based on the Miettinen and Nurminen method without stratification. Treatment difference for a response of clinical success was calculated as omadacycline minus linezolid.|||8.9|-2.2|
72484476|NCT02877927|144496166|NON_INFERIORITY|A non-inferiority margin of 10% was used for the analysis.|treatment difference|2.3|||||TWO_SIDED|95.0|-0.6|5.6|||||The 95% confidence interval was constructed based on the Miettinen and Nurminen method without stratification. Treatment difference for a response of clinical success was calculated as omadacycline minus linezolid.|||5.6|-0.6|
72484477|NCT03672461|144496183|SUPERIORITY||Model based LS mean difference|0.29||||0.056|TWO_SIDED|95.0|-0.01|0.6|||Mixed Models Analysis|adjusted for baseline value. Repeated measures mixed models, unstructured variance co-variance matrix||Null Hypothesis: Yoga is not associated with improvement in change from baseline in Total Urinary Incontinence Episodes||0.6|-0.01|0.056
72484478|NCT03672461|144496184|SUPERIORITY||Model based LS mean difference|0.03||||0.757|TWO_SIDED|95.0|-0.15|0.2|||Mixed Models Analysis|adjusted for baseline value Repeated measures mixed models, unstructured variance co-variance matrix||||0.2|-0.15|0.757
72484479|NCT03672461|144496185|SUPERIORITY||Model based LS mean difference|0.22||||0.048|TWO_SIDED|95.0|0.0|0.45|||Mixed Models Analysis|adjusted for baseline value Repeated measures mixed models, unstructured variance co-variance matrix||||0.45|0|0.048
72484480|NCT03672461|144496186|SUPERIORITY||Model based LS mean difference|0.82||||0.911|TWO_SIDED|95.0|-13.6|15.23|||Mixed Models Analysis|adjusted for baseline value Repeated measures mixed models, unstructured variance co-variance matrix||||15.23|-13.6|0.911
72484481|NCT03672461|144496187|SUPERIORITY||Model based LS mean difference|3.13||||0.041|TWO_SIDED|95.0|0.13|6.13|||Mixed Models Analysis|adjusted for baseline value Repeated measures mixed models, unstructured variance co-variance matrix||||6.13|0.13|0.041
72484482|NCT03672461|144496188|SUPERIORITY||Model based LS mean difference|0.07||||0.564|TWO_SIDED|95.0|-0.16|0.3|||Mixed Models Analysis|adjusted for baseline value Repeated measures mixed models, unstructured variance co-variance matrix||||0.3|-0.16|0.564
72484483|NCT03672461|144496189|SUPERIORITY||Model based LS mean difference|0.3||||0.764|TWO_SIDED|95.0|-1.69|2.3|||Mixed Models Analysis|adjusted for baseline value Repeated measures mixed models, unstructured variance co-variance matrix||||2.3|-1.69|0.764
72484484|NCT03672461|144496190|SUPERIORITY||Model based LS mean difference|-0.12||||0.883|TWO_SIDED|95.0|-1.78|1.53|||Mixed Models Analysis|adjusted for baseline value Repeated measures mixed models, unstructured variance co-variance matrix||||1.53|-1.78|0.883
72484485|NCT03672461|144496191|SUPERIORITY||Model based LS mean difference|-0.11||||0.753|TWO_SIDED|95.0|-0.83|0.6|||Mixed Models Analysis|adjusted for baseline value Repeated measures mixed models, unstructured variance co-variance matrix||||0.6|-0.83|0.753
72484486|NCT03672461|144496192|SUPERIORITY||Model based LS mean difference|-0.28||||0.685|TWO_SIDED|95.0|-1.63|1.07|||Mixed Models Analysis|adjusted for baseline value Repeated measures mixed models, unstructured variance co-variance matrix||||1.07|-1.63|0.685
72484487|NCT03672461|144496193|SUPERIORITY||Model based LS mean difference|0.24||||0.691|TWO_SIDED|95.0|-0.95|1.43|||Mixed Models Analysis|adjusted for baseline value Repeated measures mixed models, unstructured variance co-variance matrix||||1.43|-0.95|0.691
72512122|NCT00755846|144554253|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.3|STANDARD_ERROR_OF_MEAN|6.79||0.851||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline total cholesterol as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in total cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.851
72512123|NCT00755846|144554253|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.5|STANDARD_ERROR_OF_MEAN|6.86||0.825||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline total cholesterol as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in total cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.825
72512124|NCT00755846|144554253|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.4|STANDARD_ERROR_OF_MEAN|6.94||0.843||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline total cholesterol as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in total cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.843
72512125|NCT00755846|144554254|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.9|STANDARD_ERROR_OF_MEAN|4.88||0.069||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline total cholesterol as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in total cholesterol. The treatment effect will be evaluated as a contrast of all doses of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.069
72512126|NCT00755846|144554254|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.6|STANDARD_ERROR_OF_MEAN|6.14||0.018||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline total cholesterol as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in total cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.018
72512127|NCT00755846|144554254|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.3|STANDARD_ERROR_OF_MEAN|6.47||0.258||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline total cholesterol as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in total cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.258
72512128|NCT00755846|144554254|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.4|STANDARD_ERROR_OF_MEAN|6.13||0.299||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline total cholesterol as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in total cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.299
72567392|NCT02696031|144665643|SUPERIORITY||Odds Ratio (OR)|2.53||||0.0001|TWO_SIDED|95.0|1.58|4.07||unadjusted p-value|Regression, Logistic|||week 16|"Odds ratio, 95% CI, and p-value were from a logistic regression model with treatment, stratification factor (CRP+/MRI+, CRP+/MRI-, CRP-/MRI+) and TNFi status as factors and baseline weight and baseline score as covariates.~Missing responses for any reason were imputed as non-responders."|4.07|1.58|0.0001
72567393|NCT02696031|144665643|SUPERIORITY||Odds Ratio (OR)|2.43||||0.0002|TWO_SIDED|95.0|1.51|3.89||unadjusted p-value|Regression, Logistic|||week 16|"Odds ratio, 95% CI, and p-value were from a logistic regression model with treatment, stratification factor (CRP+/MRI+, CRP+/MRI-, CRP-/MRI+) and TNFi status as factors and baseline weight and baseline score as covariates.~Missing responses for any reason were imputed as non-responders."|3.89|1.51|0.0002
72567394|NCT02696031|144665643|SUPERIORITY||Odds Ratio (OR)|1.99||||0.0056|TWO_SIDED|95.0|1.22|3.24||unadjusted p-value|Regression, Logistic|||week 52|"Odds ratio, 95% CI, and p-value were from a logistic regression model with treatment, stratification factor (CRP+/MRI+, CRP+/MRI-, CRP-/MRI+) and TNFi status as factors and baseline weight and baseline score as covariates.~Missing responses for any reason were imputed as non-responders."|3.24|1.22|0.0056
72567395|NCT02696031|144665643|SUPERIORITY||Odds Ratio (OR)|2.34||||0.0005|TWO_SIDED|95.0|1.45|3.78||unadjusted p-value|Regression, Logistic|||week 52|"Odds ratio, 95% CI, and p-value were from a logistic regression model with treatment, stratification factor (CRP+/MRI+, CRP+/MRI-, CRP-/MRI+) and TNFi status as factors and baseline weight and baseline score as covariates.~Missing responses for any reason were imputed as non-responders."|3.78|1.45|0.0005
72567396|NCT02696031|144665644|SUPERIORITY||LS Mean of treatment difference|-0.89|STANDARD_ERROR_OF_MEAN|0.256||0.0006|TWO_SIDED|95.0|-1.39|-0.38||unadjusted p-value|mixed model repeated measures (MMRM)|||week 16|LS Mean, 95% CI, and p-value were from a mixed model repeated measures (MMRM) with treatment group, analysis visit, stratification factor (CRP+/MRI+, CRP+/MRI-, CRP-/MRI+) and TNFi status as factors, weight and baseline score as covariates, treatment by analysis visit and baseline score by analysis visit as interaction terms, using an unstructured covariance structure.|-0.38|-1.39|0.0006
72402445|NCT01480076|144311679|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 12, PPMS. Mixed effect model for repeated measures with visit, baseline MSIS-29 psychological score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
72567397|NCT02696031|144665644|SUPERIORITY||LS Mean of Treatment Difference|-0.97|STANDARD_ERROR_OF_MEAN|0.255||0.0002|TWO_SIDED|95.0|-1.47|-0.47||unadjusted p-value|mixed model repeated measures (MMRM)|||week 16|LS Mean, 95% CI, and p-value were from a mixed model repeated measures (MMRM) with treatment group, analysis visit, stratification factor (CRP+/MRI+, CRP+/MRI-, CRP-/MRI+) and TNFi status as factors, weight and baseline score as covariates, treatment by analysis visit and baseline score by analysis visit as interaction terms, using an unstructured covariance structure.|-0.47|-1.47|0.0002
72567398|NCT02696031|144665645|SUPERIORITY||LS Mean|-1.61|STANDARD_ERROR_OF_MEAN|0.478||0.0008|TWO_SIDED|95.0|-2.54|-0.67||unadjusted p-value|MMRM|||week 16|LS Mean, 95% CI, and p-value are from a mixed model repeated measures (MMRM) with treatment group, analysis visit, stratification factor (CRP+/MRI+, CRP+/MRI-, CRP-/MRI+) and TNFi status as factors, weight and baseline score as covariates, treatment by analysis visit and baseline score by analysis visit as interaction terms, using an unstructured covariance structure.|-0.67|-2.54|0.0008
72576873|NCT00261443|144680665|SUPERIORITY_OR_OTHER_LEGACY||Ratio of Remission Rate|1.01||||0.744|TWO_SIDED|95.0|0.95|1.08||Cochran-Mantel-Haenszel General Association Test controlling for mood stabilizer and index mood episode.|Cochran-Mantel-Haenszel||Aripiprazole/Placebo|Week 12||1.08|0.95|0.744
72402446|NCT01480076|144311679|SUPERIORITY_OR_OTHER|||||||0.1227|||||||mixed effect model|||Month 12, PRMS. Mixed effect model for repeated measures with visit, baseline MSIS-29 psychological score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.1227
72402447|NCT01480076|144311680|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Overall, RRMS. Mixed effect model for repeated measures with visit, baseline of the total ALS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
72402448|NCT01480076|144311680|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Overall, SPMS. Mixed effect model for repeated measures with visit, baseline of the total ALS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
72402449|NCT01480076|144311680|SUPERIORITY_OR_OTHER|||||||0.1754|||||||mixed effect model|||Overall, PPMS. Mixed effect model for repeated measures with visit, baseline of the total ALS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||0.1754
72402450|NCT01480076|144311680|SUPERIORITY_OR_OTHER|||||||0.0192|||||||mixed effect model|||Overall, PRMS. Mixed effect model for repeated measures with visit, baseline of the total ALS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0192
72402451|NCT01480076|144311680|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 3, RRMS. Mixed effect model for repeated measures with visit, baseline of the total ALS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
72402452|NCT01480076|144311680|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 3, SPMS. Mixed effect model for repeated measures with visit, baseline of the total ALS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
72402453|NCT01480076|144311680|SUPERIORITY_OR_OTHER|||||||0.0001|||||||mixed effect model|||Month 3, PPMS. Mixed effect model for repeated measures with visit, baseline of the total ALS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0001
72576874|NCT00261443|144680665|SUPERIORITY_OR_OTHER_LEGACY||Ratio of Remission Rate|1.09||||0.015|TWO_SIDED|95.0|1.02|1.17||Cochran-Mantel-Haenszel General Association Test controlling for mood stabilizer and index mood episode.|Cochran-Mantel-Haenszel||Aripiprazole/Placebo|Week 16||1.17|1.02|0.015
72402454|NCT01480076|144311680|SUPERIORITY_OR_OTHER|||||||0.0157|||||||mixed effect model|||Month 3, PRMS. Mixed effect model for repeated measures with visit, baseline of the total ALS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0157
72402455|NCT01480076|144311680|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 6, RRMS. Mixed effect model for repeated measures with visit, baseline of the total ALS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
72484488|NCT03672461|144496194|SUPERIORITY||Model based LS mean difference|0.19||||0.743|TWO_SIDED|95.0|-0.95|1.34|||Mixed Models Analysis|adjusted for baseline value Repeated measures mixed models, unstructured variance co-variance matrix||||1.34|-0.95|0.743
72484489|NCT03672461|144496195|SUPERIORITY||Model based LS mean difference|0.98||||0.043|TWO_SIDED|95.0|0.03|1.93|||Mixed Models Analysis|adjusted for baseline value Repeated measures mixed models, unstructured variance co-variance matrix||||1.93|0.03|0.043
72484490|NCT03672461|144496196|SUPERIORITY||Model based LS mean difference|0.99||||0.689|TWO_SIDED|95.0|-3.87|5.84|||Mixed Models Analysis|adjusted for baseline value Repeated measures mixed models, unstructured variance co-variance matrix||||5.84|-3.87|0.689
72484491|NCT03672461|144496197|SUPERIORITY||Model based LS mean difference|-3.4||||0.276|TWO_SIDED|95.0|-9.54|2.74|||Mixed Models Analysis|adjusted for baseline value Repeated measures mixed models, unstructured variance co-variance matrix||||2.74|-9.54|0.276
72484492|NCT03672461|144496198|SUPERIORITY||Model based LS mean difference|0.1||||0.448|TWO_SIDED|95.0|-0.15|0.34|||Mixed Models Analysis|adjusted for baseline value Repeated measures mixed models, unstructured variance co-variance matrix||||0.34|-0.15|0.448
72484493|NCT03672461|144496199|SUPERIORITY||Model based LS mean difference|-0.29||||0.319|TWO_SIDED|95.0|-0.86|0.28|||Mixed Models Analysis|adjusted for baseline value Repeated measures mixed models, unstructured variance co-variance matrix||||0.28|-0.86|0.319
72484494|NCT03672461|144496200|SUPERIORITY||Model based LS mean difference|1.21||||0.747|TWO_SIDED|95.0|-6.25|8.67|||Mixed Models Analysis|adjusted for baseline value Repeated measures mixed models, unstructured variance co-variance matrix||||8.67|-6.25|0.747
72484495|NCT03672461|144496201|SUPERIORITY||Model based LS mean difference|-2.76||||0.459|TWO_SIDED|95.0|-10.2|4.65|||Mixed Models Analysis|adjusted for baseline value Repeated measures mixed models, unstructured variance co-variance matrix||||4.65|-10.2|0.459
72484496|NCT03672461|144496202|SUPERIORITY||Model based LS mean difference|-2.0||||0.556|TWO_SIDED|95.0|-10.2|4.65|||Mixed Models Analysis|adjusted for baseline value Repeated measures mixed models, unstructured variance co-variance matrix||||4.65|-10.2|0.556
72484497|NCT03672461|144496203|SUPERIORITY||Model based LS mean difference|-3.26||||0.516|TWO_SIDED|95.0|-13.2|6.7|||Mixed Models Analysis|adjusted for baseline value Repeated measures mixed models, unstructured variance co-variance matrix||||6.7|-13.2|0.516
72484498|NCT03672461|144496204|SUPERIORITY||Model based LS mean difference|-2.38||||0.154|TWO_SIDED|95.0|-5.68|0.91|||Mixed Models Analysis|adjusted for baseline value Repeated measures mixed models, unstructured variance co-variance matrix||||0.91|-5.68|0.154
72512129|NCT00755846|144554254|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.3|STANDARD_ERROR_OF_MEAN|6.27||0.103||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline total cholesterol as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in total cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.103
72512130|NCT00755846|144554254|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.0|STANDARD_ERROR_OF_MEAN|6.32||0.34||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline total cholesterol as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in total cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.340
72512131|NCT00755846|144554255|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.83||0.689||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline HDL cholesterol as covariates.|Positive mean treatment difference indicates larger increase from baseline (more positive change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HDL cholesterol. The treatment effect will be evaluated as a contrast of all doses of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.689
72512132|NCT00755846|144554255|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3|STANDARD_ERROR_OF_MEAN|1.05||0.742||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline HDL cholesterol as covariates.|Positive mean treatment difference indicates larger increase from baseline (more positive change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HDL cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.742
72512133|NCT00755846|144554255|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.4|STANDARD_ERROR_OF_MEAN|1.11||0.22||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline HDL cholesterol as covariates.|Positive mean treatment difference indicates larger increase from baseline (more positive change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HDL cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.220
72624085|NCT05293314|144778520|OTHER|Sensitivity=number of true positives/(number of true positives+number of false negatives) \* 100% Sensitivity is the rate of correctly judging patients.We calculated the sensitivity of the breath test model to distinguish bronchiectasis from healthy people.The maximum percentage of the sensitivity is 100%. The higher the percentage is , the more sensitive of the model.|Sensitivity|86.2|||||TWO_SIDED|95.0|77.1|95.2||||||Sensitivity=number of true positives/(number of true positives+number of false negatives) \* 100% Sensitivity is the rate of correctly judging patients.We calculated the sensitivity of the breath test model to distinguish bronchiectasis from healthy people.The maximum percentage of the sensitivity is 100%. The higher the percentage is , the more sensitive of the model.||95.2|77.1|
72484499|NCT03672461|144496205|SUPERIORITY||Model based LS mean difference|-2.22||||0.375|TWO_SIDED|95.0|-7.17|2.72|||Mixed Models Analysis|adjusted for baseline value Repeated measures mixed models, unstructured variance co-variance matrix||||2.72|-7.17|0.375
72484500|NCT03672461|144496206|SUPERIORITY||Model based LS mean difference|-1.75||||0.287|TWO_SIDED|95.0|-5.0|1.5|||Mixed Models Analysis|adjusted for baseline value Repeated measures mixed models, with unstructured variance co-variance matrix||||1.5|-5|0.287
72484501|NCT03672461|144496207|SUPERIORITY||Model based LS mean difference|-1.63||||0.147|TWO_SIDED|95.0|-3.85|0.58||adjusted for baseline value Repeated measures mixed models, with unstructured variance co-variance matrix|Mixed Models Analysis|||||0.58|-3.85|0.147
72484502|NCT03672461|144496208|SUPERIORITY||Model based LS mean difference|-1.37||||0.495|TWO_SIDED|95.0|-5.36|2.61|||Mixed Models Analysis|adjusted for baseline value Repeated measures mixed models, with unstructured variance co-variance matrix||||2.61|-5.36|0.495
72484503|NCT03672461|144496209|SUPERIORITY||Model based LS mean difference|-2.82||||0.303|TWO_SIDED|95.0|-8.22|2.59|||Mixed Models Analysis|adjusted for baseline value Repeated measures mixed models, unstructured variance co-variance matrix||||2.59|-8.22|0.303
72484504|NCT03672461|144496210|SUPERIORITY||Model based LS mean difference|2.97||||0.196|TWO_SIDED|95.0|-1.56|7.51|||Mixed Models Analysis|adjusted for baseline value Repeated measures mixed models, unstructured variance co-variance matrix||||7.51|-1.56|0.196
72484505|NCT04667247|144496215|OTHER||ratio of frequencies|0.94||||1|TWO_SIDED||||||Chi-squared, Corrected|||||||1.000
72484506|NCT04667247|144496218|OTHER||ratio of frequencies|1.022||||1|TWO_SIDED||||||Chi-squared, Corrected|||||||1.000
72484507|NCT04667247|144496220|OTHER||ratio of frequencies|4.828||||0.061|TWO_SIDED||||||Chi-squared, Corrected|||||||0.061
72484508|NCT04667247|144496221|OTHER||ratio of frequencies|3.526||||0.1|TWO_SIDED||||||Chi-squared, Corrected|||||||.100
72484509|NCT04667247|144496222|OTHER||ratio of frequencies|0.005||||1|TWO_SIDED||||||Chi-squared, Corrected|||||||1.000
72484510|NCT04667247|144496223|OTHER||ratio of frequencies|3.036||||0.162|TWO_SIDED||||||Chi-squared, Corrected|||||||.162
72484511|NCT04667247|144496225|OTHER||ratio of frequencies|0.151||||1|TWO_SIDED||||||Chi-squared, Corrected|||||||1.00
72567399|NCT02696031|144665645|SUPERIORITY||LS Mean|-1.78|STANDARD_ERROR_OF_MEAN|0.479||0.0002|TWO_SIDED|95.0|-2.72|-0.84||unadjusted p-value|MMRM|||week 16|LS Mean, 95% CI, and p-value are from a mixed model repeated measures (MMRM) with treatment group, analysis visit, stratification factor (CRP+/MRI+, CRP+/MRI-, CRP-/MRI+) and TNFi status as factors, weight and baseline score as covariates, treatment by analysis visit and baseline score by analysis visit as interaction terms, using an unstructured covariance structure.|-0.84|-2.72|0.0002
72567400|NCT02696031|144665646|SUPERIORITY|||||||0.0012||||||unadjusted p-value|Wilcoxon (Mann-Whitney)|The endpoint was analyzed by composite estimand strategy. Extreme unfavorable value is assigned for patients with treatment escape or missing data.||||||0.0012
72484512|NCT04667247|144496226|SUPERIORITY||F value|1.908||||0.174|TWO_SIDED||||||Mixed Models Analysis||Group by Day interaction|||||.174
72484513|NCT04667247|144496227|SUPERIORITY||F value|0.038||||0.846|TWO_SIDED||||||Mixed Models Analysis||Group by Day interaction|||||.846
72484514|NCT04667247|144496228|SUPERIORITY||F value|0.041||||0.841|TWO_SIDED||||||Mixed Models Analysis||Day by Group interaction|||||.841
72484515|NCT04667247|144496229|SUPERIORITY||F value|0.261||||0.612|TWO_SIDED||||||Mixed Models Analysis||day by group interaction|||||0.612
72484516|NCT04667247|144496230|SUPERIORITY||F value|0.161||||0.69|TWO_SIDED||||||Mixed Models Analysis||Group by Day interaction|||||.690
72484517|NCT04667247|144496231|SUPERIORITY||F value|2.671||||0.109|TWO_SIDED||||||Mixed Models Analysis||day by group interaction|||||0.109
72484518|NCT04667247|144496232|SUPERIORITY||F value|0.039||||0.844|TWO_SIDED||||||Mixed Models Analysis||day by group interaction|||||0.844
72484519|NCT04667247|144496233|SUPERIORITY||F value|4.28||||0.044|TWO_SIDED||||||Mixed Models Analysis||day by group interaction|||||0.044
72512134|NCT00755846|144554255|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0|STANDARD_ERROR_OF_MEAN|1.05||0.348||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline HDL cholesterol as covariates.|Positive mean treatment difference indicates larger increase from baseline (more positive change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HDL cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.348
72512135|NCT00755846|144554255|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|1.06||0.627||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline HDL cholesterol as covariates.|Positive mean treatment difference indicates larger increase from baseline (more positive change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HDL cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.627
72567401|NCT02696031|144665646|SUPERIORITY||||||<|0.0001||||||unadjusted p-value|Wilcoxon (Mann-Whitney)|The endpoint was analyzed by composite estimand strategy. Extreme unfavorable value is assigned for patients with treatment escape or missing data.||||||<.0001
72484520|NCT04667247|144496234|SUPERIORITY||F value|0.001||||0.989|TWO_SIDED||||||Mixed Models Analysis||Day by Group interaction|||||.989
72484521|NCT04667247|144496235|SUPERIORITY||F value|7.186||||0.01|TWO_SIDED||||||Mixed Models Analysis||day by group interaction|||||0.010
72484522|NCT04667247|144496236|SUPERIORITY||F value|0.345||||0.56|TWO_SIDED||||||Mixed Models Analysis||Group by Day interaction|||||.560
72484523|NCT04667247|144496237|SUPERIORITY||F value|0.143||||0.707|TWO_SIDED||||||Mixed Models Analysis||day by group interaction|||||0.707
72484524|NCT04667247|144496238|SUPERIORITY||F value|0.09||||0.765|TWO_SIDED||||||Mixed Models Analysis||Day by Group interaction|||||0.765
72484525|NCT04667247|144496239|SUPERIORITY||F value|7.835||||0.005|TWO_SIDED||||||Mixed Models Analysis||day by group interaction|||||0.005
72484526|NCT04667247|144496240|SUPERIORITY||F value|16.56|||<|0.001|TWO_SIDED||||||Mixed Models Analysis||day by group interaction|||||<0.001
72484527|NCT01444651|144496241|SUPERIORITY_OR_OTHER||beta estimate|-1.25|STANDARD_ERROR_OF_MEAN|1.29||0.34|TWO_SIDED||||||Regression, Linear|||Linear regression was used to model the change in HOMA-IR (3 month minus baseline value), comparing tadalafil versus placebo groups after adjusting for baseline HOMA-IR.||||0.34
72484528|NCT01444651|144496242|SUPERIORITY_OR_OTHER||beta estimate|0.96|STANDARD_ERROR_OF_MEAN|0.68||0.18|TWO_SIDED||||||Regression, Linear|||Linear regression was used to model the change in Matsuda Index (3-month minus baseline), comparing tadalafil versus placebo groups after adjusting for baseline value.||||0.18
72484529|NCT01444651|144496243|SUPERIORITY_OR_OTHER||beta estimate|-0.18|STANDARD_ERROR_OF_MEAN|0.58||0.76|TWO_SIDED||||||Regression, Linear|||Linear regression was used to model the difference in EndoPAT (3-month minus baseline), comparing tadalafil to placebo groups after adjusting for baseline values.||||0.76
72484530|NCT01444651|144496244|SUPERIORITY_OR_OTHER||beta estimate|1.48|STANDARD_ERROR_OF_MEAN|0.77||0.06|TWO_SIDED||||||Regression, Linear|||Linear regression was used to model the change in insulinogenic index (3-month minus baseline), comparing tadalafil to placebo groups after adjusting for baseline value.||||0.06
72484531|NCT01444651|144496245|SUPERIORITY_OR_OTHER||beta estimate|3.76|STANDARD_ERROR_OF_MEAN|1.38||0.009|TWO_SIDED||||||Regression, Linear|||Linear regression was used to model the change in oral disposition index (3-month minus baseline), comparing tadalafil versus placebo groups after adjusting for baseline value.||||0.009
72484532|NCT01444651|144496246|SUPERIORITY_OR_OTHER||beta estimate|8.09|STANDARD_ERROR_OF_MEAN|4.05||0.05|TWO_SIDED||||||Regression, Linear|||Linear regression was used to model the change in Matsuda disposition index (3-month minus baseline), comparing tadalafil to placebo groups after adjusting for baseline value.||||0.05
72484533|NCT00726622|144496249|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Assuming a baseline rate of 90% oncologic success for the open resection arm, the sample size provided 80% power to declare non-inferiority if oncologic success rates were truly identical, using a 1-sided z score with α = .10 for falsely declaring non-inferiority when the true oncologic success rate for laparoscopic resection was 84%. Calculations were based on a 2-sample binomial non-inferiority calculation with a 90% success rate for the control group and a 6% non-inferiority margin.||||||0.41|||||||Wilcoxon (Mann-Whitney)|||||||0.41
72484534|NCT02462928|144496262|NON_INFERIORITY|For hypothesis testing, if the lower limit of 95.1% Confidence Interval (CI) for the difference between an abicipar group and ranibizumab was greater than or equal to -10%, non-inferiority of abicipar was established.|Percentage Difference|-3.8|||||TWO_SIDED|95.1|-8.2|0.3|||||The 95.1% CI for the weighted difference were calculated based on the Newcombe method using the Cochran-Mantel-Haenszel weights and baseline BCVA (≤55 vs \>55 letters) as stratification factor.|||0.3|-8.2|
72484535|NCT02462928|144496262|NON_INFERIORITY|For hypothesis testing, if the lower limit of 95.1% Confidence Interval (CI) for the difference between an abicipar group and ranibizumab was greater than or equal to -10%, non-inferiority of abicipar was established.|Percentage Difference|-4.2|||||TWO_SIDED|95.1|-8.7|0.0|||||The 95.1% CI for the weighted difference were calculated based on the Newcombe method using the Cochran-Mantel-Haenszel weights and baseline BCVA (≤55 vs \>55 letters) as stratification factor.|||0.0|-8.7|
72484536|NCT02462928|144496263|NON_INFERIORITY|For hypothesis testing, non-inferiority of abicipar is established if the lower limit of the CI is \> - 5.0 letters.|Least Squares (LS) Mean Difference|-2.4|STANDARD_ERROR_OF_MEAN|1.2|||TWO_SIDED|95.1|-4.7|-0.1|||||MMRM included treatment, region, BL BCVA, BL CRT ≤400 or \>400, choroidal neovascularization lesion type, visit, visit-by-BL BCVA interaction, and treatment-by-visit interaction term as covariates using an unstructured covariance matrix.|||-0.1|-4.7|
72484537|NCT02462928|144496263|NON_INFERIORITY|For hypothesis testing, non-inferiority of abicipar is established if the lower limit of the CI is \> - 5.0 letters.|LS Mean Difference|-3.7|STANDARD_ERROR_OF_MEAN|1.2|||TWO_SIDED|95.1|-6.0|-1.3|||||MMRM included treatment, region, BL BCVA, BL CRT ≤400 or \>400, choroidal neovascularization lesion type, visit, visit-by-BL BCVA interaction, and treatment-by-visit interaction term as covariates using an unstructured covariance matrix.|||-1.3|-6.0|
72484538|NCT02462928|144496264|SUPERIORITY|Superiority of abicipar was demonstrated if the lower limit of CI for the treatment difference was greater than zero.|LS Mean Difference|8.6|STANDARD_ERROR_OF_MEAN|6.3|||TWO_SIDED|95.1|-3.8|20.9|||||MMRM was used for analyses with covariates (treatment, region, baseline BCVA, CRT, choroidal neovascularization lesion type, visit, visit by baseline BCVA and treatment by visit interaction) with unstructured covariance matrix.|||20.9|-3.8|
72484539|NCT02462928|144496264|SUPERIORITY|Superiority of abicipar was demonstrated if the lower limit of CI for the treatment difference was greater than zero.|LS Mean Difference|2.3|STANDARD_ERROR_OF_MEAN|6.3|||TWO_SIDED|95.1|-10.1|14.7|||||MMRM was used for analyses with covariates (treatment, region, baseline BCVA, CRT, choroidal neovascularization lesion type, visit, visit by baseline BCVA and treatment by visit interaction) with unstructured covariance matrix.|||14.7|-10.1|
72484540|NCT02462928|144496265|SUPERIORITY||Percentage Difference|-4.7|||||TWO_SIDED|95.1|-11.5|2.1|||||The 95.1% CI for the weighted difference were calculated based on the Newcombe method using the Cochran-Mantel-Haenszel weights and baseline BCVA (≤55 vs \>55 letters) as the stratification factor.|||2.1|-11.5|
72484541|NCT02462928|144496265|SUPERIORITY||Percentage Difference|-8.2|||||TWO_SIDED|95.1|-14.7|-1.5|||||The 95.1% CI for the weighted difference were calculated based on the Newcombe method using the Cochran-Mantel-Haenszel weights and baseline BCVA (≤55 vs \>55 letters) as the stratification factor.|||-1.5|-14.7|
72484542|NCT02462928|144496266|SUPERIORITY|Superiority of abicipar was demonstrated if the lower limit of CI for the treatment difference was greater than zero.|LS Mean Difference|-1.8|STANDARD_ERROR_OF_MEAN|0.9|||TWO_SIDED|95.1|-3.7|0.0|||||MMRM was used for analyses with covariates (treatment, region, baseline BCVA, visual function questionnaire (VFQ) score, visit, visit by baseline BCVA and treatment by visit interaction) with unstructured covariance matrix.|||-0.0|-3.7|
72484543|NCT02462928|144496266|SUPERIORITY|Superiority of abicipar was demonstrated if the lower limit of CI for the treatment difference was greater than zero.|LS Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.9|||TWO_SIDED|95.1|-2.7|1.0|||||MMRM was used for analyses with covariates (treatment, region, baseline BCVA, visual function questionnaire (VFQ) score, visit, visit by baseline BCVA and treatment by visit interaction) with unstructured covariance matrix.|||1.0|-2.7|
72512136|NCT00755846|144554255|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.9|STANDARD_ERROR_OF_MEAN|1.06||0.418||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline HDL cholesterol as covariates.|Positive mean treatment difference indicates larger increase from baseline (more positive change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HDL cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.418
72512137|NCT00755846|144554256|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.5|STANDARD_ERROR_OF_MEAN|0.95||0.617||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline HDL cholesterol as covariates.|Positive mean treatment difference indicates larger increase from baseline (more positive change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HDL cholesterol. The treatment effect will be evaluated as a contrast of all doses of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.617
72512138|NCT00755846|144554256|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.3|STANDARD_ERROR_OF_MEAN|1.2||0.052||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline HDL cholesterol as covariates.|Positive mean treatment difference indicates larger increase from baseline (more positive change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HDL cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.052
72484544|NCT01493557|144496267|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.31||||0.2554|TWO_SIDED|95.0|-6.54|29.49|||Fisher Exact||Exact 95% Confidence interval (CI) and the difference between the two strategies were calculated using the Clopper Pearson approach.|Evaluation of GIS was based on Last observation carried forward (LOCF) data up to the last observed time or up to adding the second management strategy.||29.49|-6.54|0.2554
72484545|NCT01493557|144496268|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.1||||0.3165|TWO_SIDED|95.0|-11.24|24.58|||Fisher Exact||Exact 95% Confidence interval (CI) and the difference between the two strategies were calculated using the Clopper Pearson approach.|Evaluation of GIS was based on Last observation carried forward (LOCF) data up to the last observed time or up to adding the second management strategy.||24.58|-11.24|0.3165
72484546|NCT01493557|144496269|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|18.41||||0.0273|TWO_SIDED|95.0|0.71|35.98|||Fisher Exact||Exact 95% Confidence interval (CI) and the difference between the two strategies were calculated using the Clopper Pearson approach.|Evaluation of GIS was based on Last observation carried forward (LOCF) data up to the last observed time or up to adding the second management strategy.||35.98|0.71|0.0273
72484547|NCT01493557|144496270|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.52||||0.7104|TWO_SIDED|95.0|-44.22|28.4|||Fisher Exact||Exact 95% Confidence interval (CI) and the difference between the two strategies were calculated using the Clopper Pearson approach.|Evaluation of GIS was based on Last observation carried forward (LOCF) data up to the last observed time or up to adding the second management strategy.||28.40|-44.22|0.7104
72484548|NCT01493557|144496271|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.81||||1|TWO_SIDED|95.0|-32.94|40.44|||Fisher Exact||Exact 95% Confidence interval (CI) and the difference between the two strategies were calculated using the Clopper Pearson approach.|Evaluation of GIS was based on Last observation carried forward (LOCF) data up to the last observed time or up to adding the second management strategy.||40.44|-32.94|1.0000
72484549|NCT01493557|144496272|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.71||||1|TWO_SIDED|95.0|-41.25|28.77|||Fisher Exact||Exact 95% Confidence interval (CI) and the difference between the two strategies were calculated using the Clopper Pearson approach.|Evaluation of GIS was based on Last observation carried forward (LOCF) data up to the last observed time or up to adding the second management strategy.||28.77|-41.25|1.0000
72484550|NCT01493557|144496276|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5|||||TWO_SIDED|95.0|-9.9|8.9|||||Mean difference = (Mean number of days for Pradaxa w/meal) - (Mean number of days for pantoprazole).|Mean difference for the Duration of gastrointestinal symptoms (GIS).||8.9|-9.9|
72512139|NCT00755846|144554256|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|1.28||0.906||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline HDL cholesterol as covariates.|Positive mean treatment difference indicates larger increase from baseline (more positive change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HDL cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.906
72567402|NCT02696031|144665647|SUPERIORITY||Odds Ratio (OR)|1.84||||0.0577|TWO_SIDED|95.0|0.98|3.45||unadjusted p-value|Regression, Logistic|||week 52|"Odds ratio, 95% CI, and p-value were from a logistic regression model with treatment, stratification factor (CRP+/MRI+, CRP+/MRI-, CRP-/MRI+) and TNFi status as factors and baseline weight and baseline score as covariates.~Missing responses for any reason were imputed as non-responders. Patients were considered as non-responders after treatment switch decision."|3.45|0.98|0.0577
72484551|NCT01493557|144496276|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.4|||||TWO_SIDED|95.0|-3.5|6.3|||||Mean difference = (Mean number of days for Pradaxa w/meal) - (Mean number of days for pantoprazole).|Mean difference for Time to first complete effectiveness. Complete effectiveness of a gastrointestinal symptoms (GIS) management strategy can only be measured at a point in time. Because the same or a different GIS could occur after a time of effective GIS management, the patients who indicated some degree of effectiveness at one visit may not be the same patients who experience effectiveness at a subsequent visit.||6.3|-3.5|
72484552|NCT01493557|144496276|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|20.2|||||TWO_SIDED|95.0|-8.2|48.5|||||Mean difference = (Mean number of days for Pradaxa w/meal) - (Mean number of days for pantoprazole).|Mean difference for Time to first complete effectiveness. Partial effectiveness of a gastrointestinal symptoms (GIS) management strategy can only be measured at a point in time. Because the same or a different GIS could occur after a time of effective GIS management, the patients who indicated some degree of effectiveness at one visit may not be the same patients who experience effectiveness at a subsequent visit.||48.5|-8.2|
72484553|NCT02656420|144496281|EQUIVALENCE|Statistical significance of the treatment effect (p \< 0.01) for the lower doses compared to the high dose as the reference.|Mean Difference (Final Values)|-1.73|STANDARD_ERROR_OF_MEAN|0.09|<|0.001|TWO_SIDED|95.0|-1.89|-1.57||Using a linear mixed effects model with random intercepts and slope, SF level (in the log scale) was regressed on categorical treatment group (medium dose and low dose; high as the reference) as well as day (continuous variable).|Mixed Models Analysis|||The null hypothesis is that the urinary sulforaphane levels are equal across treatment arms. Sulforaphane metabolite levels were measured daily for 10 days in each arm.||-1.57|-1.89|<0.001
72484554|NCT02656420|144496282|SUPERIORITY|To summarize first 12-hour SPMA levels over the study course by participant, the SPMA geometric mean (in the log scale) for each individual was calculated and used as the outcome. Treatment arms (placebo, fifth, half and full doses) were independent (categorical) variables in a linear regression model with placebo as the reference.|Mean Difference (Final Values)|63.2|||<|0.05|TWO_SIDED|95.0|10.6|140.9|||Regression, Linear||This Estimation Parameter was based on the comparison between the full dose group and the placebo group.|All broccoli sprout arms were compared with the placebo arm.||140.9|10.6|<0.05
72484555|NCT03662139|144496300|SUPERIORITY||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||Between group difference||||<0.01
72484556|NCT03662139|144496300|SUPERIORITY||ICC|0.97|||<|0.05|TWO_SIDED|95.0|0.915|0.99|||Intraclass Correlation Coefficient(ICC)|Two-way random-effect model|Reliability estimates were interpreted as follows: \>0.90=excellent; 0.75-0.90=good; 0.50-0.75=medium; \<0.50=low|Test - Retest Reliability (Difference between 1st and 2nd assessments in Cerebral Palsy group)||0.99|0.915|<0.05
72512140|NCT00755846|144554256|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|1.19||0.628||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline HDL cholesterol as covariates.|Positive mean treatment difference indicates larger increase from baseline (more positive change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HDL cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.628
72512141|NCT00755846|144554256|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|1.22||0.749||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline HDL cholesterol as covariates.|Positive mean treatment difference indicates larger increase from baseline (more positive change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HDL cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.749
72512142|NCT00755846|144554256|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.2|STANDARD_ERROR_OF_MEAN|1.22||0.34||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline HDL cholesterol as covariates.|Positive mean treatment difference indicates larger increase from baseline (more positive change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HDL cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.340
72512143|NCT00755846|144554257|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.8|STANDARD_ERROR_OF_MEAN|4.31||0.269||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline LDL cholesterol as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in LDL cholesterol. The treatment effect will be evaluated as a contrast of all doses of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.269
72512144|NCT00755846|144554257|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.7|STANDARD_ERROR_OF_MEAN|5.46||0.076||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline LDL cholesterol as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in LDL cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.076
72512145|NCT00755846|144554257|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9|STANDARD_ERROR_OF_MEAN|5.66||0.867||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline LDL cholesterol as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in LDL cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.867
72484557|NCT03662139|144496300|SUPERIORITY||ICC|0.983|||<|0.01|TWO_SIDED|95.0|0.882|0.998|||Intraclass Correlation Coefficient(ICC)|Two-way random-effect model|Reliability estimates were interpreted as follows: \>0.90=excellent; 0.75-0.90=good; 0.50-0.75=medium; \<0.50=low|Interrater Reliability (Difference between 1st and 2nd evaluators in Cerebral Palsy group)||0.998|0.882|<0.01
72484558|NCT03662139|144496301|SUPERIORITY||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||Between group difference||||<0.01
72484559|NCT03662139|144496301|SUPERIORITY||Spearman's correlation coefficient (rs)|0.724|||<|0.05|TWO_SIDED||||||Spearman's Correlation Test|The level of relationship was classified as follows \<0.30=small/negligible; 0.30-0.50=low; 0.50-0.70=moderate; 0.70-0.90=high; \>0.90=very high.||Correlation between Dynamic Gait Index (DGI) and Pediatric Balance Scale (PBS) scores in Cerebral Palsy group||||<0.05
72484560|NCT03662139|144496302|SUPERIORITY||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||Between group difference||||<0.01
72484561|NCT03662139|144496302|SUPERIORITY||Spearman's correlation coefficient (rs)|-0.828|||<|0.01|TWO_SIDED||||||Spearman's Correlation Test||The level of relationship was classified as follows \<0.30=small/negligible; 0.30-0.50=low; 0.50-0.70=moderate; 0.70-0.90=high; \>0.90=very high.|Correlation between Dynamic Gait Index (DGI) and Timed Up and Go Test (TUG) scores in Cerebral Palsy group||||<0.01
72576875|NCT00261443|144680665|SUPERIORITY_OR_OTHER_LEGACY||Ratio of Remission Rate|1.05||||0.264|TWO_SIDED|95.0|0.97|1.14||Cochran-Mantel-Haenszel General Association Test controlling for mood stabilizer and index mood episode.|Cochran-Mantel-Haenszel||Aripiprazole/Placebo|Week 20||1.14|0.97|0.264
72484562|NCT03662139|144496303|SUPERIORITY||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||Between group difference||||<0.01
72484563|NCT03662139|144496303|SUPERIORITY||Spearman's correlation coefficient (rs)|-0.673|||<|0.05|TWO_SIDED||||||Spearman's Correlation Test||The level of relationship was classified as follows \<0.30=small/negligible; 0.30-0.50=low; 0.50-0.70=moderate; 0.70-0.90=high; \>0.90=very high.|Correlation between Dynamic Gait Index (DGI) and Four Square Step Test (FSST) scores in Cerebral Palsy group.||||<0.05
72484564|NCT01215175|144496322|OTHER||Risk Difference (RD)|10.0||||||95.0|-7.4|28.3|||||Miettinen \& Nurminen method|||28.3|-7.4|
72484565|NCT01215175|144496323|OTHER||Risk Difference (RD)|8.2||||||95.0|-7.9|26.6|||||Miettinen \& Nurminen method|||26.6|-7.9|
72484566|NCT01215175|144496323|OTHER||Risk Difference (RD)|3.6||||||95.0|-15.5|22.9|||||Miettinen \& Nurminen method|||22.9|-15.5|
72484567|NCT01215175|144496324|OTHER||Risk Difference (RD)|0.0||||||95.0|-11.5|11.5|||||Miettinen \& Nurminen method|||11.5|-11.5|
72567403|NCT02696031|144665647|SUPERIORITY||Odds Ratio (OR)|2.99||||0.0003|TWO_SIDED|95.0|1.65|5.41||unadjusted p-value|Regression, Logistic|||week 52|"Odds ratio, 95% CI, and p-value were from a logistic regression model with treatment, stratification factor (CRP+/MRI+, CRP+/MRI-, CRP-/MRI+) and TNFi status as factors and baseline weight and baseline score as covariates.~Missing responses for any reason were imputed as non-responders. Patients were considered as non-responders after treatment switch decision."|5.41|1.65|0.0003
72576876|NCT00261443|144680665|SUPERIORITY_OR_OTHER_LEGACY||Ratio of Remission Rate|1.05||||0.09|TWO_SIDED|95.0|0.99|1.11||Cochran-Mantel-Haenszel General Association Test controlling for mood stabilizer and index mood episode.|Cochran-Mantel-Haenszel||Aripiprazole/Placebo|Week 24||1.11|0.99|0.090
72402456|NCT01480076|144311680|SUPERIORITY_OR_OTHER|||||||0.0002|||||||mixed effect model|||Month 6, SPMS. Mixed effect model for repeated measures with visit, baseline of the total ALS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0002
72402457|NCT01480076|144311680|SUPERIORITY_OR_OTHER|||||||0.1012|||||||mixed effect model|||Month 6, PPMS. Mixed effect model for repeated measures with visit, baseline of the total ALS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||0.1012
72402458|NCT01480076|144311680|SUPERIORITY_OR_OTHER|||||||0.0749|||||||mixed effect model|||Month 6, PRMS. Mixed effect model for repeated measures with visit, baseline of the total ALS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0749
72402459|NCT01480076|144311680|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 9, RRMS. Mixed effect model for repeated measures with visit, baseline of the total ALS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
72484568|NCT01215175|144496325|OTHER||Risk Difference (RD)|0.0||||||95.0|-12.2|10.6|||||Miettinen \& Nurminen method|||10.6|-12.2|
72484569|NCT01215175|144496325|OTHER||Risk Difference (RD)|0.0||||||95.0|-12.3|12.3|||||Miettinen \& Nurminen method|||12.3|-12.3|
72484570|NCT01215175|144496326|OTHER||Risk Difference (RD)|10.0||||||95.0|-7.4|28.3|||||Miettinen \& Nurminen method|||28.3|-7.4|
72484571|NCT01215175|144496327|OTHER||Risk Difference (RD)|9.8||||||95.0|-10.6|30.9|||||Miettinen \& Nurminen method|||30.9|-10.6|
72484572|NCT01215175|144496327|OTHER||Risk Difference (RD)|3.6||||||95.0|-19.1|26.0|||||Miettinen \& Nurminen method|||26.0|-19.1|
72484573|NCT00702845|144496343|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Equivalence margins of -3 and +5 were applied for the difference in the mean number of oocytes between the treatment groups. Org 36286 treatment was considered equivalent to the reference treatment (recFSH) if the two-sided 95% confidence interval of the difference was between -3 and +5 oocytes.|Mean Difference (Final Values)|2.5|||<|0.001|TWO_SIDED|95.0|1.2|3.9|||ANOVA|||||3.9|1.2|<0.001
72484574|NCT02973425|144496360|OTHER||Cox Proportional Hazard|1.68||||0.02|TWO_SIDED|95.0|1.09|2.6|||Regression, Cox|||The primary hypothesis was tested through a time-to-event analysis implemented using Cox proportional hazards models||2.60|1.09|0.02
72484575|NCT02973425|144496361|OTHER||Linear regression|0.03||||0.03|TWO_SIDED|95.0|||||Regression, Linear|||For hypothesis 3, we compared the mean score on the SEQ-12 and its subscales at 6 months, adjusting for baseline.||||0.03
72484576|NCT02973425|144496362|OTHER|Six-month OR, 95%CI, and P value were calculated from generalized estimating equation marginal models with a logit link and an exchangeable correlation matrix.|Odds Ratio (OR)|1.92||||0.048|TWO_SIDED|95.0|1.01|3.68||Analysis models were adjusted by study site, having quit attempts in the past 12 months measured at baseline, cigarettes per day measured at baseline, quit attempts in the past 12 months measured at baseline.|Chi-squared|||||3.68|1.01|0.048
72484577|NCT02973425|144496363|OTHER||Odds Ratio (OR)|2.01||||0.01|TWO_SIDED|95.0|||||Regression, Linear|||During the first 3 weeks from randomization, both the Take a Break and comparison groups reported the number of cigarettes smoked daily (by texting); texting response rate (responded on at least 1 day).||||0.01
72484578|NCT01681810|144496392|OTHER|Paired t-test comparing insulin stimulated glucose disposal at end of 12 weeks on nitrite drug to baseline (pre-drug) insulin stimulated glucose disposal.||||||0.2068|||||||t-test, 2 sided|||||||0.2068
72484579|NCT01681810|144496393|OTHER|One-way repeated measures ANOVA comparing blood pressure over time on nitrite drug to baseline (pre-drug) blood pressure.||||||0.0074||||||Bonferroni adjusted p-value for multiple comparisons.|ANOVA|||||||0.0074
72484580|NCT01681810|144496394|OTHER|One-way repeated measures ANOVA comparing blood pressure over time on nitrite drug to baseline (pre-drug) blood pressure.|||||<|0.0001||||||Bonferroni adjusted p-value for multiple comparisons.|ANOVA|||||||<0.0001
72484581|NCT01681810|144496395|OTHER|One-way repeated measures ANOVA comparing blood pressure over time on nitrite drug to baseline (pre-drug) blood pressure.|||||<|0.0001||||||Bonferroni adjusted p-value for multiple comparisons.|ANOVA|||||||<0.0001
72484582|NCT01681810|144496396|OTHER|One-way repeated measures ANOVA comparing methemoglobin percent over time on nitrite drug to baseline (pre-drug) methemoglobin percent.||||||0.0127||||||Bonferroni adjusted p-value for multiple comparisons.|ANOVA|||||||0.0127
72484583|NCT03823404|144496404|SUPERIORITY||||||<|0.0455||||||The interim analysis was conducted at significance level of 0.05 and the significance level was adjusted for final analysis.|mixed-effects model for repeated measure|||||||<0.0455
72484584|NCT03823404|144496405|SUPERIORITY||||||<|455|||||||Mixed Models Analysis|||||||<0455
72484585|NCT03383289|144496419|SUPERIORITY||Beta estimate of the percent who fell|0.118|STANDARD_ERROR_OF_MEAN|0.145||0.417|TWO_SIDED||||||Mixed Models Analysis|MIANALYZE was used to model missing data. Models were adjusted for the design effects of clustering.||||||0.4170
72484586|NCT03383289|144496421|OTHER|paired t test|Mean Difference (Final Values)|-1.353|STANDARD_ERROR_OF_MEAN|0.181|<|0.001|TWO_SIDED|95.0|-1.708|-0.998|||paired t test|||Analysis of adjusted mean differences using a paired t test procedure||-0.998|-1.708|<0.001
72484587|NCT03383289|144496422|SUPERIORITY||Beta|0.6364|STANDARD_ERROR_OF_MEAN|0.233||0.0064|TWO_SIDED|95.0|0.1797|1.0931|||Poisson regression|||||1.0931|0.1797|0.0064
72484588|NCT03383289|144496422|SUPERIORITY||Estimated log mean|-4.0168||||0.001|TWO_SIDED|95.0|-5.5827|-2.4509|||Poisson regression|||||-2.4509|-5.5827|0.001
72576877|NCT00261443|144680665|SUPERIORITY_OR_OTHER_LEGACY||Ratio of Remission Rate|1.08||||0.056|TWO_SIDED|95.0|1.0|1.17||Cochran-Mantel-Haenszel General Association Test controlling for mood stabilizer and index mood episode.|Cochran-Mantel-Haenszel||Aripiprazole/Placebo|Week 28||1.17|1.00|0.056
72576878|NCT00261443|144680665|SUPERIORITY_OR_OTHER_LEGACY||Ratio of Remission Rate|0.99||||0.756|TWO_SIDED|95.0|0.93|1.05||Cochran-Mantel-Haenszel General Association Test controlling for mood stabilizer and index mood episode.|Cochran-Mantel-Haenszel||Aripiprazole/Placebo|Week 32||1.05|0.93|0.756
72484589|NCT03383289|144496423|OTHER|adjusted mean differences from paired t tests|Mean Difference (Final Values)|-0.456|STANDARD_ERROR_OF_MEAN|0.162||0.005|TWO_SIDED|95.0|-0.774|-0.138|||paired t test|||||-0.138|-0.774|0.005
72576879|NCT00261443|144680665|SUPERIORITY_OR_OTHER_LEGACY||Ratio of Remission Rate|1.05||||0.177|TWO_SIDED|95.0|0.98|1.13||Cochran-Mantel-Haenszel General Association Test controlling for mood stabilizer and index mood episode.|Cochran-Mantel-Haenszel||Aripiprazole/Placebo|Week 36||1.13|0.98|0.177
72576880|NCT00261443|144680665|SUPERIORITY_OR_OTHER_LEGACY||Ratio of Remission Rate|1.07||||0.021|TWO_SIDED|95.0|1.01|1.13||Cochran-Mantel-Haenszel General Association Test controlling for mood stabilizer and index mood episode.|Cochran-Mantel-Haenszel||Aripiprazole/Placebo|Week 40||1.13|1.01|0.021
72576881|NCT00261443|144680665|SUPERIORITY_OR_OTHER_LEGACY||Ratio of Remission Rate|1.06||||0.216|TWO_SIDED|95.0|0.96|1.16||Cochran-Mantel-Haenszel General Association Test controlling for mood stabilizer and index mood episode.|Cochran-Mantel-Haenszel||Aripiprazole/Placebo|Week 44||1.16|0.96|0.216
72484590|NCT01002456|144496441|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.9|||||TWO_SIDED|95.0|1.1|3.2|||||Proportional odds ratio to measure the trend of change in concordance with guideline recommendations, with Arm 1 as the comparator.|||3.2|1.1|
72484591|NCT03829241|144496570|SUPERIORITY||LS Mean Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.7||0.917|TWO_SIDED|95.0|-1.45|1.3|||Mixed Models Analysis|||Model-based summary statistics are from a mixed model with repeated measures, including fixed effects for treatment, visit, treatment-by-visit interaction, baseline score, baseline score-by-visit interaction as covariates, and participant as random effect.||1.30|-1.45|0.917
72484592|NCT00698451|144496576|SUPERIORITY_OR_OTHER||Percentage|72.2||||0.05|TWO_SIDED|95.0|58.4|83.5|||Exact Binomial Distribution|||||83.5|58.4|0.05
72484593|NCT02308007|144496595|SUPERIORITY|||||||0.03|||||||Chi-squared, Corrected|||||||0.030
72484594|NCT02308007|144496595|SUPERIORITY|||||||0.073|||||||Chi-squared, Corrected|||||||0.073
72484595|NCT02308007|144496595|SUPERIORITY|||||||0.0204|||||||Cochran-Mantel-Haenszel|||Stratified by race (black, white, or other race)||||0.0204
72484596|NCT02308007|144496595|SUPERIORITY|||||||0.0493|||||||Cochran-Mantel-Haenszel|||Stratified by race (black, white, or other race)||||0.0493
72484597|NCT02308007|144496596|SUPERIORITY|||||||0.015|||||||Chi-squared, Corrected|||||||0.015
72484598|NCT02308007|144496596|SUPERIORITY|||||||0.193|||||||Chi-squared, Corrected|||Difference for Terconazole/metronidazole vaginal gel cures minus metronidazole vaginal gel cures||||0.193
72484599|NCT02308007|144496597|SUPERIORITY|||||||0.012|||||||Chi-squared, Corrected|||||||0.012
72484600|NCT02308007|144496597|SUPERIORITY|||||||0.918|||||||Chi-squared, Corrected|||||||0.918
72484601|NCT00528567|144496606|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.87||||0.181|TWO_SIDED|95.0|0.72|1.07|||Log Rank|Stratification factors were axillary nodal status, choice of adjuvant chemotherapy, hormone receptor status, surgery.||||1.07|0.72|0.1810
72484602|NCT00528567|144496608|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.93||||0.5247|TWO_SIDED|95.0|0.74|1.17|||Log Rank|Stratification factors are Axillary nodal status, Choice of adjuvant chemotherapy, Hormone receptor status, Surgery||||1.17|0.74|0.5247
72484603|NCT00528567|144496610|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.87||||0.1966|TWO_SIDED|95.0|0.71|1.07|||Log Rank||Stratification factors were axillary nodal status, choice of adjuvant chemotherapy, hormone receptor status, surgery.|||1.07|0.71|0.1966
72484604|NCT00528567|144496611|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.84||||0.2318|TWO_SIDED|95.0|0.64|1.12|||Log Rank|||||1.12|0.64|0.2318
72484605|NCT00528567|144496614|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.89||||0.2792|TWO_SIDED|95.0|0.72|1.1|||Log Rank||Stratification factors were axillary nodal status, choice of adjuvant chemotherapy, hormone receptor status, surgery.|||1.10|0.72|0.2792
72484606|NCT00528567|144496616|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.87||||0.1832|TWO_SIDED|95.0|0.72|1.07|||Log Rank||Stratification factors were axillary nodal status, choice of adjuvant chemotherapy, hormone receptor status, surgery.|||1.07|0.72|0.1832
72484607|NCT00528567|144496618|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.9||||0.3309|TWO_SIDED|95.0|0.72|1.12|||Log Rank||Stratification factors were axillary nodal status, choice of adjuvant chemotherapy, hormone receptor status, surgery.|||1.12|0.72|0.3309
72484608|NCT01063829|144496642|SUPERIORITY_OR_OTHER|||||||0.007|||||||Fisher Exact|||||||0.007
72484609|NCT01063829|144496642|SUPERIORITY_OR_OTHER|||||||0.014|||||||Fisher Exact|||||||0.014
72484610|NCT01063829|144496642|SUPERIORITY_OR_OTHER|||||||0.321|||||||Fisher Exact|||||||0.321
72484611|NCT01063829|144496643|SUPERIORITY_OR_OTHER|||||||0.002|||||||Log Rank|||||||0.002
72484612|NCT01063829|144496643|SUPERIORITY_OR_OTHER|||||||0.126|||||||Log Rank|||||||0.126
72484613|NCT01063829|144496643|SUPERIORITY_OR_OTHER|||||||0.148|||||||Log Rank|||||||0.148
72484614|NCT01063829|144496644|SUPERIORITY_OR_OTHER|||||||0.007|||||||Fisher Exact|||||||0.007
72484615|NCT01063829|144496644|SUPERIORITY_OR_OTHER|||||||0.014|||||||Fisher Exact|||||||0.014
72484616|NCT01063829|144496644|SUPERIORITY_OR_OTHER|||||||0.321|||||||Fisher Exact|||||||0.321
72484617|NCT00056862|144496668|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||t-test, 2 sided|||Null hypothesis: first phase decline in HCV RNA are the same for the two groups||||0.002
72484618|NCT00056862|144496670|SUPERIORITY_OR_OTHER|||||||0.2|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||Null hypothesis: the second phase slopes of HCV RNA are the same for the two groups||||0.2
72484619|NCT00056862|144496671|SUPERIORITY_OR_OTHER|||||||0.047|TWO_SIDED|95.0|||||Log Rank|||Null hypothesis: the time to negativity for the two groups are same||||0.047
72484620|NCT01829360|144496672|SUPERIORITY||||||<|0.05|TWO_SIDED|95.0|||||Mixed Models Analysis|The significance of fixed effects (e.g.,treatment) was evaluated using Wald tests||||||<0.05
72484621|NCT01829360|144496672|OTHER|A secondary analysis was performed to examine individual differences in treatment outcomes. This was done collapsed across all arms because the difference between the arms/treatments was not significant in the primary analysis. This was done by adding predictors to the primary analysis model to determine if learner characteristics were significantly related to growth in word defining. All continuous learner characteristics were grand mean centered.|||||<|0.05|TWO_SIDED|95.0|||||Mixed Models Analysis|||||||<0.05
72512146|NCT00755846|144554257|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.4|STANDARD_ERROR_OF_MEAN|5.4||0.169||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline LDL cholesterol as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in LDL cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.169
72512147|NCT00755846|144554257|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.5|STANDARD_ERROR_OF_MEAN|5.45||0.645||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline LDL cholesterol as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in LDL cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.645
72512148|NCT00755846|144554257|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.2|STANDARD_ERROR_OF_MEAN|5.51||0.351||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline LDL cholesterol as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in LDL cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.351
72512149|NCT00755846|144554258|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.3|STANDARD_ERROR_OF_MEAN|4.03||0.003||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline LDL cholesterol as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in LDL cholesterol. The treatment effect will be evaluated as a contrast of all doses of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.003
72512150|NCT00755846|144554258|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|17.6|STANDARD_ERROR_OF_MEAN|5.06|<|0.001||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline LDL cholesterol as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in LDL cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||<0.001
72512151|NCT00755846|144554258|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.6|STANDARD_ERROR_OF_MEAN|5.26||0.103||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline LDL cholesterol as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in LDL cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.103
72512152|NCT00755846|144554258|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.0|STANDARD_ERROR_OF_MEAN|4.98||0.009||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline LDL cholesterol as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in LDL cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.009
72512153|NCT00755846|144554258|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.0|STANDARD_ERROR_OF_MEAN|5.14||0.034||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline LDL cholesterol as covariates|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in LDL cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.034
72402460|NCT01480076|144311680|SUPERIORITY_OR_OTHER|||||||0.0455|||||||mixed effect model|||Month 9, SPMS. Mixed effect model for repeated measures with visit, baseline of the total ALS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0455
72484622|NCT01829360|144496673|SUPERIORITY||||||<|0.05|TWO_SIDED|95.0|||||Mixed Models Analysis|||The interim definition data were analyzed with the primary pre-/post-definition data to capture growth across the entire treatment period.||||<0.05
72484623|NCT00846885|144496685|NON_INFERIORITY_OR_EQUIVALENCE|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|110.0||||||90.0|103.0|117.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||117|103|
72484624|NCT00846885|144496686|NON_INFERIORITY_OR_EQUIVALENCE|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|106.0||||||90.0|102.0|111.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||111|102|
72484625|NCT00846885|144496687|NON_INFERIORITY_OR_EQUIVALENCE|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|105.0||||||90.0|101.0|110.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||110|101|
72484626|NCT01862640|144496689|SUPERIORITY||Least square (LS) mean difference|-3.77|||=|0.0404|TWO_SIDED|95.0|-7.38|-0.17|||Mixed-effect model repeated measure|||||-0.17|-7.38|=0.0404
72484627|NCT01862640|144496689|SUPERIORITY||LS mean difference|0.23|||=|0.9015|TWO_SIDED|95.0|-3.4|3.86|||Mixed-effect model repeated measure|||||3.86|-3.40|=0.9015
72484628|NCT01862640|144496690|SUPERIORITY||LS mean difference|-0.16|||=|0.1566|TWO_SIDED|95.0|-0.39|0.06|||Mixed-effect model repeated measure|||||0.06|-0.39|=0.1566
72484629|NCT01862640|144496690|SUPERIORITY||LS mean difference|0.09|||=|0.444|TWO_SIDED|95.0|-0.14|0.32|||Mixed-effect model repeated measure|||||0.32|-0.14|=0.4440
72484630|NCT04884763|144496691|SUPERIORITY||Mean Difference (Final Values)|0.3||||0.567|TWO_SIDED|95.0|-0.76|1.35||A two-sided 5% significance level was used for all tests without multiplicity adjustment between multiple endpoints.|Mixed Models Analysis|Model included factors for treatment group, time, and their interaction, with time repeated within subject. Gender as a covariate.|For difference calculation, Arm A - Arm B|Based on two-sided paired t-tests and two-sample t-tests, all conducted at a 5% significance level, this pilot study had 80% power to detect effect sizes of 1.2 for differences between groups. To account for dropout, the study enrolled 15 patients per group, for a total of 30 patients.||1.35|-0.76|0.567
72512154|NCT00755846|144554258|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.1|STANDARD_ERROR_OF_MEAN|5.16||0.033||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline LDL cholesterol as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in LDL cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.033
72512155|NCT00755846|144554259|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.2|STANDARD_ERROR_OF_MEAN|17.17||0.897||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline triglycerides as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in triglycerides. The treatment effect will be evaluated as a contrast of all doses of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.897
72512156|NCT00755846|144554259|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.8|STANDARD_ERROR_OF_MEAN|21.85||0.557||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline triglycerides as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in triglycerides. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.557
72512157|NCT00755846|144554259|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.5|STANDARD_ERROR_OF_MEAN|22.85||0.616||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline triglycerides as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in triglycerides. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.616
72567404|NCT02696031|144665648|SUPERIORITY||Relative Treatment Effect|0.7||||0.0002|TWO_SIDED|95.0|0.58|0.84||unadjusted p-value|MMRM|||week 16|Analysis was done on the log(e) ratio of the treatment value vs. baseline value to normalize the distribution of the hsCRP at each visit. LS Mean, SE, 95% CI and p-value were from mixed-effect model repeated measures (MMRM) with treatment, visit, stratification factor and TNFi status as factors, log(e) baseline and weight as covariates, treatment by visit and log(e) baseline by visit as interaction terms and an unstructured covariance|0.84|0.58|0.0002
72576882|NCT00261443|144680665|SUPERIORITY_OR_OTHER_LEGACY||Ratio of Remission Rate|1.07||||0.017|TWO_SIDED|95.0|1.01|1.15||Cochran-Mantel-Haenszel General Association Test controlling for mood stabilizer and index mood episode.|Cochran-Mantel-Haenszel||Aripiprazole/Placebo|Week 48||1.15|1.01|0.017
72484631|NCT04884763|144496692|SUPERIORITY||Mean Difference (Final Values)|0.15||||0.778|TWO_SIDED|95.0|-0.91|1.21||A two-sided 5% significance level was used for all tests without multiplicity adjustment between multiple endpoints.|Mixed Models Analysis|Model included factors for treatment group, time, and their interaction, with time repeated within subject. Gender as a covariate.|For difference calculation, Arm A - Arm B|Based on two-sided paired t-tests and two-sample t-tests, all conducted at a 5% significance level, this pilot study had 80% power to detect effect sizes of 1.2 for differences between groups. To account for dropout, the study enrolled 15 patients per group, for a total of 30 patients.||1.21|-0.91|0.778
72484632|NCT04884763|144496693|SUPERIORITY||Mean Difference (Final Values)|0.88||||0.105|TWO_SIDED|95.0|-0.2|1.96||A two-sided 5% significance level was used for all tests without multiplicity adjustment between multiple endpoints.|Mixed Models Analysis|Model included factors for treatment group, time, and their interaction, with time repeated within subject. Gender as a covariate.|For difference calculation, Arm A - Arm B|Based on two-sided paired t-tests and two-sample t-tests, all conducted at a 5% significance level, this pilot study had 80% power to detect effect sizes of 0.9 for changes over time within groups and effect sizes of 1.2 for differences between groups. To account for dropout, the study enrolled 15 patients per group, for a total of 30 patients.||1.96|-0.20|0.105
72484633|NCT04884763|144496694|SUPERIORITY||Mean Difference (Final Values)|17.5||||0.163|TWO_SIDED|95.0|-7.6|42.7||A two-sided 5% significance level was used for all tests without multiplicity adjustment between multiple endpoints.|Mixed Models Analysis|Model included factors for treatment group, time, and their interaction, with time repeated within subject. Gender as a covariate.|For difference calculation, Arm A - Arm B|Based on two-sided paired t-tests and two-sample t-tests, all conducted at a 5% significance level, this pilot study had 80% power to detect effect sizes of 0.9 for changes over time within groups and effect sizes of 1.2 for differences between groups. To account for dropout, the study enrolled 15 patients per group, for a total of 30 patients.||42.7|-7.6|0.163
72402461|NCT01480076|144311680|SUPERIORITY_OR_OTHER|||||||0.4699|||||||mixed effect model|||Month 9, PPMS. Mixed effect model for repeated measures with visit, baseline of the total ALS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||0.4699
72484634|NCT04884763|144496695|SUPERIORITY||Mean Difference (Final Values)|-0.06||||0.91|TWO_SIDED|95.0|-1.13|1.01||A two-sided 5% significance level was used for all tests without multiplicity adjustment between multiple endpoints.|Mixed Models Analysis|Model included factors for treatment group, time, and their interaction, with time repeated within subject. Gender as a covariate.|For difference calculation, Arm A - Arm B|Based on two-sided paired t-tests and two-sample t-tests, all conducted at a 5% significance level, this pilot study had 80% power to detect effect sizes of 0.9 for changes over time within groups and effect sizes of 1.2 for differences between groups. To account for dropout, the study enrolled 15 patients per group, for a total of 30 patients.||1.01|-1.13|0.910
72512158|NCT00755846|144554259|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.0|STANDARD_ERROR_OF_MEAN|21.73||0.679||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline triglycerides as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in triglycerides. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.679
72402462|NCT01480076|144311680|SUPERIORITY_OR_OTHER|||||||0.0235|||||||mixed effect model|||Month 9, PRMS. Mixed effect model for repeated measures with visit, baseline of the total ALS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0235
72484635|NCT04884763|144496696|SUPERIORITY||Mean Difference (Final Values)|-0.01||||0.972|TWO_SIDED|95.0|-0.83|0.8||A two-sided 5% significance level was used for all tests without multiplicity adjustment between multiple endpoints.|Mixed Models Analysis|Model included factors for treatment group, time, and their interaction, with time repeated within subject. Gender as a covariate.|For difference calculation, Arm A - Arm B|Based on two-sided paired t-tests and two-sample t-tests, all conducted at a 5% significance level, this pilot study had 80% power to detect effect sizes of 0.9 for changes over time within groups and effect sizes of 1.2 for differences between groups. To account for dropout, the study enrolled 15 patients per group, for a total of 30 patients.||0.80|-0.83|0.972
72484636|NCT04884763|144496697|SUPERIORITY||Mean Difference (Final Values)|2.81||||0.037|TWO_SIDED|95.0|0.18|5.43||A two-sided 5% significance level was used for all tests without multiplicity adjustment between multiple endpoints.|Mixed Models Analysis|Model included factors for treatment group, time, and their interaction, with time repeated within subject. Gender as a covariate.|For difference calculation, Arm A - Arm B|Based on two-sided paired t-tests and two-sample t-tests, all conducted at a 5% significance level, this pilot study had 80% power to detect effect sizes of 0.9 for changes over time within groups and effect sizes of 1.2 for differences between groups. To account for dropout, the study enrolled 15 patients per group, for a total of 30 patients.||5.43|0.18|0.037
72484637|NCT04884763|144496698|SUPERIORITY||Mean Difference (Final Values)|-0.26||||0.885|TWO_SIDED|95.0|-3.95|3.43||A two-sided 5% significance level was used for all tests without multiplicity adjustment between multiple endpoints.|Mixed Models Analysis|Model included factors for treatment group, time, and their interaction, with time repeated within subject. Gender as a covariate.|For difference calculation, Arm A - Arm B|Based on two-sided paired t-tests and two-sample t-tests, all conducted at a 5% significance level, this pilot study had 80% power to detect effect sizes of 0.9 for changes over time within groups and effect sizes of 1.2 for differences between groups. To account for dropout, the study enrolled 15 patients per group, for a total of 30 patients.||3.43|-3.95|0.885
72484638|NCT04884763|144496699|SUPERIORITY||Mean Difference (Final Values)|0.47||||0.474|TWO_SIDED|95.0|-0.87|1.81||A two-sided 5% significance level was used for all tests without multiplicity adjustment between multiple endpoints.|Mixed Models Analysis|Model included factors for treatment group, time, and their interaction, with time repeated within subject. Gender as a covariate.|For difference calculation, Arm A - Arm B|Based on two-sided paired t-tests and two-sample t-tests, all conducted at a 5% significance level, this pilot study had 80% power to detect effect sizes of 1.2 for differences between groups. To account for dropout, the study enrolled 15 patients per group, for a total of 30 patients.||1.81|-0.87|0.474
72512159|NCT00755846|144554259|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.5|STANDARD_ERROR_OF_MEAN|21.94||0.697||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline triglycerides as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in triglycerides. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.697
72512160|NCT00755846|144554259|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.4|STANDARD_ERROR_OF_MEAN|22.03||0.672||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline triglycerides as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in triglycerides. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.672
72512161|NCT00755846|144554260|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.0|STANDARD_ERROR_OF_MEAN|16.37||0.809||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline triglycerides as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in triglycerides. The treatment effect will be evaluated as a contrast of all doses of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.809
72512162|NCT00755846|144554260|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.0|STANDARD_ERROR_OF_MEAN|20.74||0.597||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline triglycerides as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in triglycerides. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.597
72512163|NCT00755846|144554260|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|21.77||0.982||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline triglycerides as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in triglycerides. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.982
72512164|NCT00755846|144554260|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.0|STANDARD_ERROR_OF_MEAN|20.62||0.358||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline triglycerides as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in triglycerides. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.358
72512165|NCT00755846|144554260|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|23.1|STANDARD_ERROR_OF_MEAN|21.06||0.274||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline triglycerides as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in triglycerides. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.274
72512166|NCT00755846|144554260|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.5|STANDARD_ERROR_OF_MEAN|21.06||0.554||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline triglycerides as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in triglycerides. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.554
72512167|NCT02669862|144554277|OTHER|||||||0.555|||||||ANCOVA|Baseline values were the covariate||"In this table Study Day 01 / Visit 2 has been considered as Baseline visit for calculating mean and mean change.~PVal\*- ANCOVA used for calculating P-value by comparing Vehicle against each Active treatment group using baseline values as the covariate."||||0.555
72512168|NCT02669862|144554277|OTHER|||||||0.009||||||PVal\*- ANCOVA used for calculating P-value by comparing Vehicle against each Active treatment group using baseline values as the covariate. No adjustments for multiple comparisons.|ANCOVA|||"In this table Study Day 01 / Visit 2 has been considered as Baseline visit for calculating mean and mean change.~PVal\*- ANCOVA used for calculating P-value by comparing Vehicle against each Active treatment group using baseline values as the covariate."||||0.009
72402463|NCT01480076|144311680|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 12, RRMS. Mixed effect model for repeated measures with visit, baseline of the total ALS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
72402464|NCT01480076|144311680|SUPERIORITY_OR_OTHER|||||||0.1978|||||||mixed effect model|||Month 12, SPMS. Mixed effect model for repeated measures with visit, baseline of the total ALS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||0.1978
72484639|NCT04884763|144496700|SUPERIORITY||Mean Difference (Final Values)|-0.19||||0.822|TWO_SIDED|95.0|-1.94|1.56||A two-sided 5% significance level was used for all tests without multiplicity adjustment between multiple endpoints.|Mixed Models Analysis|Model included factors for treatment group, time, and their interaction, with time repeated within subject. Gender as a covariate.|For difference calculation, Arm A - Arm B|Based on two-sided paired t-tests and two-sample t-tests, all conducted at a 5% significance level, this pilot study had 80% power to detect effect sizes of 1.2 for differences between groups. To account for dropout, the study enrolled 15 patients per group, for a total of 30 patients.||1.56|-1.94|0.822
72484640|NCT04884763|144496701|SUPERIORITY||Mean Difference (Final Values)|0.51||||0.455|TWO_SIDED|95.0|-0.88|1.91||A two-sided 5% significance level was used for all tests without multiplicity adjustment between multiple endpoints.|Mixed Models Analysis|Model included factors for treatment group, time, and their interaction, with time repeated within subject. Gender as a covariate.|For difference calculation, Arm A - Arm B|Based on two-sided paired t-tests and two-sample t-tests, all conducted at a 5% significance level, this pilot study had 80% power to detect effect sizes of 0.9 for changes over time within groups and effect sizes of 1.2 for differences between groups. To account for dropout, the study enrolled 15 patients per group, for a total of 30 patients.||1.91|-0.88|0.455
72484641|NCT04884763|144496702|SUPERIORITY||Mean Difference (Final Values)|7.1||||0.467|TWO_SIDED|95.0|-12.8|27.0||A two-sided 5% significance level was used for all tests without multiplicity adjustment between multiple endpoints.|Mixed Models Analysis|Model included factors for treatment group, time, and their interaction, with time repeated within subject. Gender as a covariate.|For difference calculation, Arm A - Arm B|Based on two-sided paired t-tests and two-sample t-tests, all conducted at a 5% significance level, this pilot study had 80% power to detect effect sizes of 0.9 for changes over time within groups and effect sizes of 1.2 for differences between groups. To account for dropout, the study enrolled 15 patients per group, for a total of 30 patients.||27.0|-12.8|0.467
72484642|NCT04884763|144496703|SUPERIORITY||Mean Difference (Final Values)|0.14||||0.755|TWO_SIDED|95.0|-0.79|1.07||A two-sided 5% significance level was used for all tests without multiplicity adjustment between multiple endpoints.|Mixed Models Analysis|Model included factors for treatment group, time, and their interaction, with time repeated within subject. Gender as a covariate.|For difference calculation, Arm A - Arm B|Based on two-sided paired t-tests and two-sample t-tests, all conducted at a 5% significance level, this pilot study had 80% power to detect effect sizes of 0.9 for changes over time within groups and effect sizes of 1.2 for differences between groups. To account for dropout, the study enrolled 15 patients per group, for a total of 30 patients.||1.07|-0.79|0.755
72484643|NCT04884763|144496704|SUPERIORITY||Mean Difference (Final Values)|-0.23||||0.613|TWO_SIDED|95.0|-1.18|0.71||A two-sided 5% significance level was used for all tests without multiplicity adjustment between multiple endpoints.|Mixed Models Analysis|Model included factors for treatment group, time, and their interaction, with time repeated within subject. Gender as a covariate.|For difference calculation, Arm A - Arm B|Based on two-sided paired t-tests and two-sample t-tests, all conducted at a 5% significance level, this pilot study had 80% power to detect effect sizes of 0.9 for changes over time within groups and effect sizes of 1.2 for differences between groups. To account for dropout, the study enrolled 15 patients per group, for a total of 30 patients.||0.71|-1.18|0.613
72484644|NCT04884763|144496705|SUPERIORITY||Mean Difference (Final Values)|2.58||||0.003|TWO_SIDED|95.0|0.94|4.22||A two-sided 5% significance level was used for all tests without multiplicity adjustment between multiple endpoints.|Mixed Models Analysis|Model included factors for treatment group, time, and their interaction, with time repeated within subject. Gender as a covariate.|For difference calculation, Arm A - Arm B|Based on two-sided paired t-tests and two-sample t-tests, all conducted at a 5% significance level, this pilot study had 80% power to detect effect sizes of 0.9 for changes over time within groups and effect sizes of 1.2 for differences between groups. To account for dropout, the study enrolled 15 patients per group, for a total of 30 patients.||4.22|0.94|0.003
72512169|NCT02669862|144554279|OTHER|||||||0.9313||||||Not adjusted for multiple comparisons|Chi-squared|||PVal\*- Chi-Square test used for calculating P-value by comparing Vehicle against each Active treatment group||||0.9313
72512170|NCT02669862|144554279|OTHER|||||||0.0236||||||Not adjusted for multiple comparisons|Chi-squared|||||||0.0236
72512171|NCT05138783|144554280|NON_INFERIORITY|Noninferiority in distance VA was declared if upper confidence limit was less than 0.05.|Least squares mean difference|-0.01|STANDARD_ERROR_OF_MEAN|0.004|||ONE_SIDED|95.0||0.0||Since a noninferiority hypothesis is being tested, a p-value is not applicable. Confidence limit is being reported and compared to the noninferiority margin.|||LSM results based on mixed effects repeated measures model with both fixed (lens, period, and sequence) and random (subject) effects. Difference = PRECISION1 minus BIOTRUE. Sign (either negative or positive) is retained with the rounded value.|||0.00||
72512172|NCT02429258|144554285|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-24.0|STANDARD_ERROR_OF_MEAN|6.08|<|0.001||95.0|-36.1|-12.0|||Mixed Models Analysis|||||-12.0|-36.1|<0.001
72402465|NCT01480076|144311680|SUPERIORITY_OR_OTHER|||||||0.1977|||||||mixed effect model|||Month 12, PPMS. Mixed effect model for repeated measures with visit, baseline of the total ALS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||0.1977
72402466|NCT01480076|144311680|SUPERIORITY_OR_OTHER|||||||0.225|||||||mixed effect model|||Month 12, PRMS. Mixed effect model for repeated measures with visit, baseline of the total ALS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||0.2250
72402467|NCT01480076|144311681|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Overall, RRMS. Mixed effect model for repeated measures with visit, baseline of the current health state of EQ-5D scores, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
72402468|NCT01480076|144311681|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Overall, SPMS. Mixed effect model for repeated measures with visit, baseline of the current health state of EQ-5D scores, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
72402469|NCT01480076|144311681|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Overall, PPMS. Mixed effect model for repeated measures with visit, baseline of the current health state of EQ-5D scores, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
72402470|NCT01480076|144311681|SUPERIORITY_OR_OTHER|||||||0.0649|||||||mixed effect model|||Overall, PRMS. Mixed effect model for repeated measures with visit, baseline of the current health state of EQ-5D scores, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0649
72402471|NCT01480076|144311681|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 3, RRMS. Mixed effect model for repeated measures with visit, baseline of the current health state of EQ-5D scores, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
72402472|NCT01480076|144311681|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 3, SPMS. Mixed effect model for repeated measures with visit, baseline of the current health state of EQ-5D scores, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
72402473|NCT01480076|144311681|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 3, PPMS. Mixed effect model for repeated measures with visit, baseline of the current health state of EQ-5D scores, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
72402474|NCT01480076|144311681|SUPERIORITY_OR_OTHER|||||||0.1138|||||||mixed effect model|||Month 3, PRMS. Mixed effect model for repeated measures with visit, baseline of the current health state of EQ-5D scores, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||0.1138
72402475|NCT01480076|144311681|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 6, RRMS. Mixed effect model for repeated measures with visit, baseline of the current health state of EQ-5D scores, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
72402476|NCT01480076|144311681|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 6, SPMS. Mixed effect model for repeated measures with visit, baseline of the current health state of EQ-5D scores, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
72402477|NCT01480076|144311681|SUPERIORITY_OR_OTHER|||||||0.0003|||||||mixed effect model|||Month 6, PPMS. Mixed effect model for repeated measures with visit, baseline of the current health state of EQ-5D scores, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0003
72512173|NCT02429258|144554286|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.3|STANDARD_ERROR_OF_MEAN|5.8||0.01||95.0|-26.8|-3.8|||ANCOVA|||||-3.8|-26.8|0.010
72402478|NCT01480076|144311681|SUPERIORITY_OR_OTHER|||||||0.185|||||||mixed effect model|||Month 6, PRMS. Mixed effect model for repeated measures with visit, baseline of the current health state of EQ-5D scores, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||0.1850
72512174|NCT02429258|144554287|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.0|STANDARD_ERROR_OF_MEAN|0.42||0.023||95.0|0.1|1.8|||ANCOVA|||||1.8|0.1|0.023
72512175|NCT02429258|144554288|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|15.0|STANDARD_ERROR_OF_MEAN|3.65|<|0.001||95.0|7.7|22.2|||ANCOVA|||||22.2|7.7|<0.001
72512176|NCT02429258|144554289|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.1|STANDARD_ERROR_OF_MEAN|3.72|<|0.001||95.0|-23.5|-8.7|||ANCOVA|||||-8.7|-23.5|<0.001
72512177|NCT02429258|144554290|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-29.7|STANDARD_ERROR_OF_MEAN|8.47|<|0.001||95.0|-46.6|-12.9|||ANCOVA|||||-12.9|-46.6|<0.001
72484645|NCT04884763|144496706|SUPERIORITY||Mean Difference (Final Values)|1.19||||0.536|TWO_SIDED|95.0|-2.7|5.08||A two-sided 5% significance level was used for all tests without multiplicity adjustment between multiple endpoints.|Mixed Models Analysis|Model included factors for treatment group, time, and their interaction, with time repeated within subject. Gender as a covariate.|For difference calculation, Arm A - Arm B|Based on two-sided paired t-tests and two-sample t-tests, all conducted at a 5% significance level, this pilot study had 80% power to detect effect sizes of 0.9 for changes over time within groups and effect sizes of 1.2 for differences between groups. To account for dropout, the study enrolled 15 patients per group, for a total of 30 patients.||5.08|-2.70|0.536
72484646|NCT00778622|144496761|SUPERIORITY_OR_OTHER|||||||0.0806||||||Interpretation based on 2-sided 5% significance level.|ANCOVA|Change from baseline in HbA1c at Week 16 was dependent variable, BMI was fixed main effect, baseline HbA1c was covariate.||"Standard deviation assumed for changes from baseline in HbA1c maximally was 1.0 across the baseline BMI subgroups. 97 participants in a single subgroup would be sufficient to estimate mean change in HbA1c with precision of 0.20% within the subgroup. Given number of baseline BMI subgroups and no correction for reason of multiplicity was made to the 95% CI within each BMI subgroup, total sample size calculated as 291. Sample size used the method CI for mean for one group in nQuery Advisor v6.0."||||0.0806
72484647|NCT00778622|144496761|SUPERIORITY_OR_OTHER|||||||0.1984||||||Interpretation of two-by-two comparison based on 2-sided 5% significance level without correction for multiplicity.|t-test, 2 sided|||||||0.1984
72484648|NCT00778622|144496761|SUPERIORITY_OR_OTHER|||||||0.0232||||||Interpretation of two-by-two comparison based on 2-sided 5% significance level without correction for multiplicity.|t-test, 2 sided|||||||0.0232
72484649|NCT00778622|144496761|SUPERIORITY_OR_OTHER|||||||0.3589||||||Interpretation of two-by-two comparison based on 2-sided 5% significance level without correction for multiplicity.|t-test, 2 sided|||||||0.3589
72484650|NCT00778622|144496762|SUPERIORITY_OR_OTHER|||||||0.4614||||||Interpretation based on 2-sided 5% significance level.|ANCOVA|Change from baseline in FPG at Week 16 was dependent variable, BMI was fixed main effect, baseline FPG was covariate.||||||0.4614
72484651|NCT00778622|144496762|SUPERIORITY_OR_OTHER|||||||0.4696||||||Interpretation of two-by-two comparison based on 2-sided 5% significance level without correction for multiplicity.|t-test, 2 sided|||||||0.4696
72484652|NCT00778622|144496762|SUPERIORITY_OR_OTHER|||||||0.5305||||||Interpretation of two-by-two comparison based on 2-sided 5% significance level without correction for multiplicity.|t-test, 2 sided|||||||0.5305
72484653|NCT00778622|144496762|SUPERIORITY_OR_OTHER|||||||0.9145||||||Interpretation of two-by-two comparison based on 2-sided 5% significance level without correction for multiplicity.|t-test, 2 sided|||||||0.9145
72484654|NCT00778622|144496763|SUPERIORITY_OR_OTHER|||||||0.0305||||||Interpretation based on 2-sided 5% significance level.|ANCOVA|Change from baseline in TC at Week 16 was dependent variable, BMI was fixed main effect, baseline TC was covariate.||||||0.0305
72484655|NCT00778622|144496763|SUPERIORITY_OR_OTHER|||||||0.008||||||Interpretation of two-by-two comparison based on 2-sided 5% significance level without correction for multiplicity. For lipids, no comparison between overweight and obese was performed.|t-test, 2 sided|||||||0.0080
72484656|NCT00778622|144496763|SUPERIORITY_OR_OTHER|||||||0.0422||||||Interpretation of two-by-two comparison based on 2-sided 5% significance level without correction for multiplicity. For lipids, no comparison between overweight and obese was performed.|t-test, 2 sided|||||||0.0422
72484657|NCT00778622|144496764|SUPERIORITY_OR_OTHER|||||||0.4508||||||Interpretation based on 2-sided 5% significance level.|ANCOVA|Change from baseline in LDL-C at Week 16 was dependent variable, BMI was fixed main effect, baseline LDL-C was covariate.||||||0.4508
72484658|NCT00778622|144496764|SUPERIORITY_OR_OTHER|||||||0.0526||||||Interpretation of two-by-two comparison based on 2-sided 5% significance level without correction for multiplicity. For lipids, no comparison between overweight and obese was performed.|t-test, 2 sided|||||||0.0526
72484659|NCT00778622|144496764|SUPERIORITY_OR_OTHER|||||||0.1295||||||Interpretation of two-by-two comparison based on 2-sided 5% significance level without correction for multiplicity. For lipids, no comparison between overweight and obese was performed.|t-test, 2 sided|||||||0.1295
72484660|NCT00778622|144496765|SUPERIORITY_OR_OTHER|||||||0.1431||||||Interpretation based on 2-sided 5% significance level.|ANCOVA|Change from baseline in HDL-C at Week 16 was dependent variable, BMI was fixed main effect, baseline HDL-C was covariate.||||||0.1431
72484661|NCT00778622|144496765|SUPERIORITY_OR_OTHER|||||||0.4066||||||Interpretation of two-by-two comparison based on 2-sided 5% significance level without correction for multiplicity. For lipids, no comparison between overweight and obese was performed.|t-test, 2 sided|||||||0.4066
72484662|NCT00778622|144496765|SUPERIORITY_OR_OTHER|||||||0.4071||||||Interpretation of two-by-two comparison based on 2-sided 5% significance level without correction for multiplicity. For lipids, no comparison between overweight and obese was performed.|t-test, 2 sided|||||||0.4071
72484663|NCT00778622|144496766|SUPERIORITY_OR_OTHER|||||||0.021||||||Interpretation based on 2-sided 5% significance level.|ANCOVA|Change from baseline in TG at Week 16 was dependent variable, BMI was fixed main effect, baseline TG was covariate.||||||0.0210
72484664|NCT00778622|144496766|SUPERIORITY_OR_OTHER|||||||0.2507||||||Interpretation of two-by-two comparison based on 2-sided 5% significance level without correction for multiplicity. For lipids, no comparison between overweight and obese was performed.|t-test, 2 sided|||||||0.2507
72484665|NCT00778622|144496766|SUPERIORITY_OR_OTHER|||||||0.6546||||||Interpretation of two-by-two comparison based on 2-sided 5% significance level without correction for multiplicity. For lipids, no comparison between overweight and obese was performed.|t-test, 2 sided|||||||0.6546
72484666|NCT03427125|144496810|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
72484667|NCT03427125|144496811|SUPERIORITY|||||||0.002|||||||ANCOVA|||||||0.0020
72484668|NCT03610165|144496843|SUPERIORITY||Median Difference (Final Values)|0.0||||0.757|TWO_SIDED|95.0|-0.03|0.04|||Wilcoxon (Mann-Whitney)|||||0.04|-0.03|0.757
72484669|NCT03610165|144496844|SUPERIORITY||Median Difference (Final Values)|-1.3||||0.715|TWO_SIDED|95.0|-12.0|7.0|||Wilcoxon (Mann-Whitney)|||||7|-12|0.715
72484670|NCT03610165|144496845|SUPERIORITY||Median Difference (Final Values)|-1.0||||0.328|TWO_SIDED|95.0|-3.3|1.0|||Wilcoxon (Mann-Whitney)|||||1|-3.3|0.328
72484671|NCT03610165|144496846|SUPERIORITY||Median Difference (Final Values)|0.0||||0.376|TWO_SIDED|95.0|-0.001|0.011|||Wilcoxon (Mann-Whitney)|||||0.011|-0.001|0.376
72402479|NCT01480076|144311681|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 9, RRMS. Mixed effect model for repeated measures with visit, baseline of the current health state of EQ-5D scores, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
72402480|NCT01480076|144311681|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 9, SPMS. Mixed effect model for repeated measures with visit, baseline of the current health state of EQ-5D scores, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
72512178|NCT02429258|144554291|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-40.8|STANDARD_ERROR_OF_MEAN|9.14|<|0.001||95.0|-59.0|-22.7|||ANCOVA|||||-22.7|-59.0|<0.001
72512179|NCT02429258|144554292|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.23|STANDARD_ERROR_OF_MEAN|0.1||0.024||95.0|-0.43|-0.03|||ANCOVA|||||-0.03|-0.43|0.024
72402481|NCT01480076|144311681|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 9, PPMS. Mixed effect model for repeated measures with visit, baseline of the current health state of EQ-5D scores, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
72567405|NCT02696031|144665648|SUPERIORITY||Relative Treatment Effect|0.7||||0.0002||95.0|0.58|0.84||unadjusted p-value|MMRM|||week 16|Analysis was done on the log(e) ratio of the treatment value vs. baseline value to normalize the distribution of the hsCRP at each visit. LS Mean, SE, 95% CI and p-value were from mixed-effect model repeated measures (MMRM) with treatment, visit, stratification factor and TNFi status as factors, log(e) baseline and weight as covariates, treatment by visit and log(e) baseline by visit as interaction terms and an unstructured covariance structure.|0.84|0.58|0.0002
72484672|NCT03610165|144496847|SUPERIORITY||Median Difference (Final Values)|0.0||||0.226|TWO_SIDED|95.0|0.0|0.0|||Wilcoxon (Mann-Whitney)|||||0|0|0.226
72484673|NCT03610165|144496848|SUPERIORITY||Median Difference (Final Values)|0.0||||0.61|TWO_SIDED|95.0|-0.67|2.0|||Wilcoxon (Mann-Whitney)|||||2.00|-0.67|0.610
72484674|NCT03610165|144496849|SUPERIORITY||Median Difference (Final Values)|0.0||||0.302|TWO_SIDED|95.0|0.0|0.0|||Wilcoxon (Mann-Whitney)|||||0|0|0.302
72484675|NCT03610165|144496850|SUPERIORITY||Median Difference (Final Values)|0.0||||0.889|TWO_SIDED|95.0|-0.67|0.67|||Wilcoxon (Mann-Whitney)|||||0.67|-0.67|0.889
72484676|NCT03610165|144496851|SUPERIORITY||Median Difference (Final Values)|0.0||||0.403|TWO_SIDED|95.0|0.0|0.0|||Wilcoxon (Mann-Whitney)|||||0|0|0.403
72484677|NCT00708175|144496854|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.55||||0.17|TWO_SIDED|95.0|-1.33|0.24||P-value is from a 1-way ANCOVA with treatment group as a factor and baseline BMD as a covariate. There were no multiplicity adjustments.|ANCOVA|||The sample size was calculated using a precision approach to estimate the difference between the pioglitazone and placebo treatment groups in the percent change from baseline in BMD.||0.24|-1.33|0.170
72484678|NCT00708175|144496855|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.17||||0.64|TWO_SIDED|95.0|-0.91|0.56||P-value is from a 1-way ANCOVA with treatment group as a factor and the Month 12 BMD value as a covariate. There were no multiplicity adjustments.|ANCOVA|||||0.56|-0.91|0.640
72484679|NCT01703663|144496871|SUPERIORITY_OR_OTHER||absolute difference|-5.73||||0.183|TWO_SIDED|95.0|-14.4|2.97|||ANOVA|||||2.97|-14.4|0.183
72484680|NCT00315939|144496872|SUPERIORITY_OR_OTHER||||||=|0.001|||||||ANOVA|||||||=0.001
72484681|NCT01436071|144496887|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.12||||0.012|TWO_SIDED|95.0|0.026|0.213|||ANCOVA|||||0.213|0.026|0.012
72484682|NCT00789867|144496893|OTHER|||||||0.0002|||||||Kruskal-Wallis|||||||0.0002
72484683|NCT00789867|144496894|OTHER|||||||0.22|||||||Kruskal-Wallis|||||||0.22
72484684|NCT00789867|144496895|OTHER|||||||0.06|||||||Kruskal-Wallis|||||||0.06
72484685|NCT00789867|144496896|OTHER|||||||0.08|||||||Kruskal-Wallis|||||||0.08
72484686|NCT00789867|144496897|OTHER|||||||0.22|||||||Kruskal-Wallis|||||||0.22
72484687|NCT00789867|144496898|OTHER|||||||0.003|||||||Kruskal-Wallis|||||||0.003
72484688|NCT03503513|144496907|SUPERIORITY||Risk Ratio (RR)|0.17|||<|0.0001|TWO_SIDED|95.0|0.03|0.2|||differences in incidence rate ratio|An incidence rate ratio per person/month was determined by comparing the total number of UTIs in relation to time points.||comparison between pre and during treatment rates of UTI||0.20|0.03|<0.0001
72484689|NCT03503513|144496908|SUPERIORITY||Mean Difference (Final Values)|-3.8|STANDARD_DEVIATION|6.13|<|0.06|TWO_SIDED|95.0|-7.9|0.3||a priori threshold p value of \<0.05|t-test, 2 sided||Baseline to end of 6 month treatment score comparisons; (higher numbers represent more symptoms or complications)|NBSS Domain score for incontinence pre-post comparison; small sample size did not allow for power calculation.||0.3|-7.9|<0.06
72484690|NCT03503513|144496908|SUPERIORITY||Mean Difference (Final Values)|-1.1|STANDARD_DEVIATION|4.09|<|0.39|TWO_SIDED|95.0|-3.8|1.7||a priori threshold p\<0.05|t-test, 2 sided||(higher numbers represent more symptoms or complications)|NBSS Domain score for storage and voiding; pre-post comparison. Due to small sample size (n=11) no power calculations were conducted.||1.7|-3.8|<0.39
72484691|NCT03503513|144496908|SUPERIORITY||Mean Difference (Final Values)|-1.9|STANDARD_DEVIATION|3.99|<|0.14|TWO_SIDED|95.0|-4.6|0.8|||t-test, 2 sided||Higher numbers represent more symptoms or complications referred as consequences.|Pre and post test comparisons of mean NBSS scores for the consequences domain. Power calculations were not conducted due to small sample size.||0.8|-4.6|<0.14
72484692|NCT03503513|144496909|SUPERIORITY||Mean Difference (Final Values)|-2.1|STANDARD_DEVIATION|6.99|<|0.34|TWO_SIDED|95.0|-6.8|2.6|||t-test, 2 sided|||||2.6|-6.8|<0.34
72484693|NCT01191541|144496927|NON_INFERIORITY|The primary objective was to demonstrate the noninferiority of DNR alone to DNR+ARA-C in the rate of DFS at 2 years. Assuming a 95% rate of DFS in the two groups, a margin of -15% , 5% type 1 error, 80% power, 30 evaluable patients per group were required to draw a noninferiority conclusion.|||||<|0.05||||||the p-value is not adjusted|Log Rank|||The characteristics of all of the included patients were summarized using cross-tabulations (for categorical variables) and quantiles. Nonparametric tests were used to analyse comparisons between groups .EFS、disease-free survival (DFS) and OS were estimated using the Kaplan -Meier method, and log-rank tests were used. All P values were two-sided, and those with values of 0.05 or less were considered to be statistically significant.||||<0.05
72402482|NCT01480076|144311681|SUPERIORITY_OR_OTHER|||||||0.0887|||||||mixed effect model|||Month 9, PRMS. Mixed effect model for repeated measures with visit, baseline of the current health state of EQ-5D scores, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0887
72402483|NCT01480076|144311681|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 12, RRMS. Mixed effect model for repeated measures with visit, baseline of the current health state of EQ-5D scores, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
72402484|NCT01480076|144311681|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 12, SPMS. Mixed effect model for repeated measures with visit, baseline of the current health state of EQ-5D scores, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
72512180|NCT02429258|144554293|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.8|STANDARD_ERROR_OF_MEAN|4.55||0.019||95.0|-19.9|-1.8|||ANCOVA|||||-1.8|-19.9|0.019
72512181|NCT02429258|144554294|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-36.3|STANDARD_ERROR_OF_MEAN|9.25|<|0.001||95.0|-54.7|-17.9|||ANCOVA|||||-17.9|-54.7|<0.001
72512182|NCT02429258|144554295|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.0|STANDARD_ERROR_OF_MEAN|2.86||0.017||95.0|1.3|12.7|||ANCOVA|||||12.7|1.3|0.017
72512183|NCT02397694|144554296|NON_INFERIORITY|Noninferiority of treatment with BIC + F/TAF relative to treatment with DTG + F/TAF. Noninferiority assessed using a conventional 95% confidence interval (CI) approach, with a noninferiority margin of 12%|Difference in percentages|2.9||||0.5|TWO_SIDED|95.0|-8.5|14.2|||Cochran-Mantel-Haenszel|Cochran-Mantel Haenszel test stratified by baseline HIV-1 RNA stratum (≤ 100,000 copies/mL vs \> 100,000 copies/mL).||||14.2|-8.5|0.5
72512184|NCT00078559|144554312|SUPERIORITY_OR_OTHER||Proportion with acute rejection|0.1|||||TWO_SIDED|95.0|0.01|0.34|||95% Confidence Interval|Exact Binomial||||0.34|0.01|
72512185|NCT00078559|144554313|SUPERIORITY_OR_OTHER||Proportion with acute rejection|0.0|||||TWO_SIDED|95.0|0.0|0.3|||95% Confidence Interval|Exact Binomial||||0.3|0.0|
72567406|NCT02696031|144665649|SUPERIORITY||LS Mean of Treatment Difference|2.77|STANDARD_ERROR_OF_MEAN|0.799||0.0006|TWO_SIDED|95.0|1.2|4.34||unadjusted p-value|ANCOVA|||week 16|LS Mean, 95% CI, and p-value were from a mixed model repeated measures (MMRM) with treatment group, analysis visit, stratification factor (CRP+/MRI+, CRP+/MRI-, CRP-/MRI+) and TNFi status as factors, weight and baseline score as covariates, treatment by analysis visit and baseline score by analysis visit as interaction terms, using an unstructured covariance structure.|4.34|1.20|0.0006
72512186|NCT00078559|144554314|SUPERIORITY_OR_OTHER||Proportion with acute rejection|0.0|||||TWO_SIDED|95.0|0.0|0.7|||95% Confidence Interval|Exact Binomial||||0.7|0.0|
72512187|NCT00078559|144554317|SUPERIORITY_OR_OTHER||Exact Binomial|0.0|||||TWO_SIDED|95.0|0.0|0.3|||95% Confidence Interval|Exact Binomial||||0.3|0.0|
72576883|NCT00261443|144680665|SUPERIORITY_OR_OTHER_LEGACY||Ratio of Remission Rate|1.06||||0.083|TWO_SIDED|95.0|0.99|1.13||Cochran-Mantel-Haenszel General Association Test controlling for mood stabilizer and index mood episode.|Cochran-Mantel-Haenszel||Aripiprazole/Placebo|Week 52||1.13|0.99|0.083
72402485|NCT01480076|144311681|SUPERIORITY_OR_OTHER|||||||0.0011|||||||mixed effect model|||Month 12, PPMS. Mixed effect model for repeated measures with visit, baseline of the current health state of EQ-5D scores, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0011
72512188|NCT00078559|144554318|SUPERIORITY_OR_OTHER||Exact Binomial|0.0|||||TWO_SIDED|95.0|0.0|0.3|||95% Confidence Interval|Exact Binomial for all participants (n=10)||||0.3|0.0|
72512189|NCT00078559|144554319|SUPERIORITY_OR_OTHER||Exact Binomial|0.0|||||TWO_SIDED|95.0|0.0|0.4|||95% Confidence Interval|Exact Binomial for Not Withdrawn Group||||0.4|0.0|
72512190|NCT00078559|144554319|SUPERIORITY_OR_OTHER||Exact Binomial|0.0|||||TWO_SIDED|95.0|0.0|0.8|||95% Confidence Interval|Exact Binomial for Withdrawn Group||||0.8|0.0|
72512191|NCT00078559|144554320|SUPERIORITY_OR_OTHER||Exact Binomial|0.0|||||TWO_SIDED|95.0|0.0|0.4|||95% Confidence Interval|Exact Binomial for Not Withdrawn Group||||0.4|0.0|
72512192|NCT00078559|144554320|SUPERIORITY_OR_OTHER||Exact Binomial|0.0|||||TWO_SIDED|95.0|0.0|0.8|||95% Confidence Interval|Exact Binomial for Withdrawn Group||||0.8|0.0|
72512193|NCT03725202|144554328|SUPERIORITY|Across the strata, 95% CI for adjusted difference and p-value are calculated according to the Cochran-Mantel-Haenszel test adjusted for strata (Baseline CS dose (prednisone or prednisolone \> 30 mg or ≤30 mg) and disease status (new onset or relapsing disease)) for the comparison of two treatment groups. Within each stratum, 95% CI for difference are calculated using normal approximation to the binomial distribution.|Adjusted Response Rate Difference|17.1|||=|0.0019|TWO_SIDED|95.0|6.3|27.8|||Cochran-Mantel-Haenszel||Response rate difference = 15 mg Upadacitinib - Placebo|15 mg Upadacitinib + 26-week CS taper vs Placebo + 52-week CS taper||27.8|6.3|=0.0019
72512194|NCT03725202|144554328|SUPERIORITY|Across the strata, 95% CI for adjusted difference and p-value are calculated according to the Cochran-Mantel-Haenszel test adjusted for strata (Baseline CS dose (prednisone or prednisolone \> 30 mg or ≤30 mg) and disease status (new onset or relapsing disease)) for the comparison of two treatment groups. Within each stratum, 95% CI for difference are calculated using normal approximation to the binomial distribution.|Adjusted Response Rate Difference|12.1|||=|0.0579|TWO_SIDED|95.0|-0.4|24.6|||Cochran-Mantel-Haenszel||Response rate difference = 7.5 mg Upadacitinib - Placebo|7.5 mg Upadacitinib + 26-week CS taper vs Placebo + 52-week CS taper||24.6|-0.4|=0.0579
72512195|NCT03725202|144554329|SUPERIORITY|Across the strata, 95% CI for adjusted difference and p-value are calculated according to the Cochran-Mantel-Haenszel test adjusted for strata (Baseline CS dose (prednisone or prednisolone \> 30 mg or ≤30 mg) and disease status (new onset or relapsing disease)) for the comparison of two treatment groups. Within each stratum, 95% CI for difference are calculated using normal approximation to the binomial distribution.|Adjusted Response Rate Difference|20.7|||<|0.0001|TWO_SIDED|95.0|11.3|30.2|||Cochran-Mantel-Haenszel||Response rate difference = 15 mg Upadacitinib - Placebo|15 mg Upadacitinib + 26-week CS taper vs Placebo + 52-week CS taper||30.2|11.3|<0.0001
72402486|NCT01480076|144311681|SUPERIORITY_OR_OTHER|||||||0.1853|||||||mixed effect model|||Month 12, PRMS. Mixed effect model for repeated measures with visit, baseline of the current health state of EQ-5D scores, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||0.1853
72567407|NCT02696031|144665649|SUPERIORITY||LS Mean of Treatment Difference|2.64|STANDARD_ERROR_OF_MEAN|0.803||0.0011|TWO_SIDED|95.0|1.06|4.22||unadjusted p-value|ANCOVA|||week 16|LS Mean, 95% CI, and p-value were from a mixed model repeated measures (MMRM) with treatment group, analysis visit, stratification factor (CRP+/MRI+, CRP+/MRI-, CRP-/MRI+) and TNFi status as factors, weight and baseline score as covariates, treatment by analysis visit and baseline score by analysis visit as interaction terms, using an unstructured covariance structure.|4.22|1.06|0.0011
72484694|NCT00729781|144496964|SUPERIORITY_OR_OTHER||Percent of subjects with improvement|57.8||||0.19|ONE_SIDED|97.5|42.2||||One-sided, binomial exact test|||This study had two independent primary endpoints (cosmetic and functional improvement). Therefore, the assumed type I error rate for each was 2.5% in order to maintain an overall 5% type I error rate. For each endpoint, the percent of subjects with improvement of the total number implanted was to be compared to a rate of 50% using a one-sided, binomial exact test. If the p-value was \< 0.025, the objective would have been met.|||42.2|0.19
72484695|NCT00729781|144496965|SUPERIORITY_OR_OTHER||Percent of subjects with improvement|15.6|||>|0.99|ONE_SIDED|97.5|0.05||||One-sided, binomial exact test||||||0.05|>0.99
72484696|NCT00006392|144497017|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.13|||<|0.01|TWO_SIDED|99.0|0.95|1.35||The p-value was adjusted for multiple comparisons.|Regression, Cox|||Per study design, with a sample size of 32,400 men, using a 1-sided alpha=.005 level (equivalent to a 2-sided alpha=.01 level) there was 96% power to detect a 25% reduction in prostate cancer for either agent vs. Placebo.||1.35|0.95|< .01
72484697|NCT00006392|144497017|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.04|||<|0.01|TWO_SIDED|99.0|0.87|1.24||The p-value was adjusted for multiple comparisons.|Regression, Cox|||Per study design, with a sample size of 32,400 men, using a 1-sided alpha=.005 level (equivalent to a 2-sided alpha=.01 level) there was 96% power to detect a 25% reduction in prostate cancer for either agent vs. Placebo.||1.24|0.87|< .01
72484698|NCT00006392|144497017|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.05|||<|0.01||99.0|0.88|1.25||The p-value was adjusted for multiple comparisons.|Regression, Cox|||Per study design, with a sample size of 32,400 men, using a 1-sided alpha=.005 level (equivalent to a 2-sided alpha=.01 level) there was 99% power to detect a 44% reduction in prostate cancer for combination vs. Placebo.||1.25|.88|< .01
72484699|NCT00006392|144497018|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.0|||>|0.05||99.0|0.64|1.55||The trial was designed to study prostate cancer and lung cancer has a lower incidence rate, there was limited power to look at lung cancer incidence. A 99% CI (rather than a 95% CI) was used to adjust for the multiple comparisons.|Regression, Cox||The placebo was the denominator.|||1.55|.64|> .05
72484700|NCT00006392|144497018|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.12|||>|0.01|TWO_SIDED|99.0|0.73|1.72||The trial was designed to study prostate cancer and lung cancer has a lower incidence rate, there was limited power to look at lung cancer incidence. A 99% CI (rather than a 95% CI) was used to adjust for the multiple comparisons.|Regression, Cox||The placebo was the denominator.|||1.72|0.73|> .01
72484701|NCT00006392|144497018|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.16|||>|0.01|TWO_SIDED|99.0|0.9|1.16||The trial was designed to study prostate cancer and lung cancer has a lower incidence rate, there was limited power to look at lung cancer incidence. A 99% CI (rather than a 95% CI) was used to adjust for the multiple comparisons.|Regression, Cox||The placebo was the denominator.|||1.16|0.90|>.01
72484702|NCT00006392|144497019|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.09|||>|0.05|TWO_SIDED|99.0|0.69|1.73||A 99% CI (rather than a 95% CI) was used to adjust for the multiple comparisons.|Regression, Cox||The placebo was the denominator.|The trial was designed to study prostate cancer and colorectal cancer has a lower incidence rate, there was limited power to look at colorectal cancer incidence.||1.73|0.69|> .05
72484703|NCT00006392|144497019|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.05|||>|0.05|TWO_SIDED|99.0|0.66|1.67||A 99% CI (rather than a 95% CI) was used to adjust for the multiple comparisons.|Regression, Cox||The placebo was the denominator.|The trial was designed to study prostate cancer and colorectal cancer has a lower incidence rate, there was limited power to look at colorectal cancer incidence.||1.67|0.66|> .05
72484704|NCT00006392|144497019|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.28|||>|0.05|TWO_SIDED|99.0|0.82|2.0||A 99% CI (rather than a 95% CI) was used to adjust for the multiple comparisons.|Regression, Cox||The placebo was the denominator.|The trial was designed to study prostate cancer and colorectal cancer has a lower incidence rate, there was limited power to look at colorectal cancer incidence.||2.00|0.82|> .05
72484705|NCT00006392|144497020|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.03|||>|0.05|TWO_SIDED|99.0|0.91|1.17||A 99% CI (rather than a 95% CI) was used to adjust for the multiple comparisons.|Regression, Cox||The placebo was the denominator.|The power to look at all cancer incidence is greater than 90%.||1.17|0.91|> .05
72484706|NCT00006392|144497020|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.01|||>|0.05|TWO_SIDED|99.0|0.89|1.15||A 99% CI (rather than a 95% CI) was used to adjust for the multiple comparisons.|Regression, Cox||The placebo was the denominator.|The power to look at all cancer incidence is greater than 90%.||1.15|0.89|> .05
72484707|NCT00006392|144497020|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.02|||>|0.05||99.0|0.9|1.16||A 99% CI (rather than a 95% CI) was used to adjust for the multiple comparisons.|Regression, Cox||The placebo was the denominator.|The power to look at all cancer incidence is greater than 90%.||1.16|0.90|> .05
72567408|NCT02696031|144665650|SUPERIORITY||||||<|0.0001||||||unadjusted p-value|ANCOVA|||week 16|"LS Mean, 95% CI, and p-value were from an ANCOVA model with treatment group and stratification factor (CRP+/MRI+, CRP+/MRI-, CRP-/MRI+) and TNFi status as factors, weight and baseline score as covariates.~Missing data were imputed using multiple imputation (MI, MAR assumption) prior to running ANCOVA."|||<0.0001
72576884|NCT00261443|144680666|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|0.78||||0.132|TWO_SIDED|95.0|0.56|1.08|||Stratified Log Rank Test|Stratified Log Rank Test p-value for equality of survival curves.||||1.08|0.56|0.132
72484708|NCT00006392|144497021|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.93|||>|0.05||99.0|0.77|1.13||A 99% CI (rather than a 95% CI) was used to adjust for the multiple comparisons.|Regression, Cox||The placebo is the denominator.|Only results from overall survival are presented as the number of cancer-specific deaths is too few to be meaningful.||1.13|0.77|> .05
72484709|NCT00006392|144497021|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.99|||>|0.05|TWO_SIDED|99.0|0.82|1.19||A 99% CI (rather than a 95% CI) was used to adjust for the multiple comparisons.|Regression, Cox||The placebo was the denominator.|Only results from overall survival are presented as the number of cancer-specific deaths is too few to be meaningful.||1.19|0.82|> .05
72484710|NCT00006392|144497021|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.94|||>|0.05|TWO_SIDED|99.0|0.77|1.13||A 99% CI (rather than a 95% CI) was used to adjust for the multiple comparisons.|Regression, Cox|||Only results from overall survival are presented as the number of cancer-specific deaths is too few to be meaningful.||1.13|0.77|> .05
72484711|NCT00006392|144497022|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.98|||>|0.05|TWO_SIDED|99.0|0.88|1.09||A 99% CI (rather than a 95% CI) was used to adjust for the multiple comparisons.|Chi-squared||The placebo was the denominator.|||1.09|0.88|> .05
72484712|NCT00006392|144497022|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.02|||>|0.05|TWO_SIDED|99.0|0.92|1.13||A 99% CI (rather than a 95% CI) was used to adjust for the multiple comparisons.|Chi-squared||The placebo was the denominator.|||1.13|0.92|> .05
72484713|NCT00006392|144497022|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.99|||>|0.05|TWO_SIDED|99.0|0.89|1.1||A 99% CI (rather than a 95% CI) was used to adjust for the multiple comparisons.|Chi-squared||The placebo was the denominator.|||1.10|0.89|> .05
72484714|NCT01186796|144497023|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||t-test, 2 sided|||||||<0.05
72484715|NCT01186796|144497024|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||ANOVA|Two-way ANOVA in a 2x4 factorial nested design with repeated measures.||||||<0.05
72484716|NCT01186796|144497025|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|||||"Unit of mass secreted per burst is in ug/L. An automated deconvolution method was used and mathematically verified by direct statistical proof and empirically validated using hypothalamopituitary sampling and a simulated pulsatile time series."|ANOVA|Two-way ANOVA in a 2x4 factorial nested design with repeated measures.||||||<0.05
72484717|NCT01186796|144497026|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||ANOVA|Two-way ANOVA in a 2x4 factorial nested design with repeated measures.||||||<0.05
72484718|NCT01186796|144497027|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||ANOVA|Two-way ANOVA in a 2x4 factorial nested design with repeated measures.||||||<0.05
72567409|NCT02696031|144665650|SUPERIORITY||||||<|0.0001||||||unadjusted p-value|ANCOVA|||week 16|"LS Mean, 95% CI, and p-value were from an ANCOVA model with treatment group and stratification factor (CRP+/MRI+, CRP+/MRI-, CRP-/MRI+) and TNFi status as factors, weight and baseline score as covariates.~Missing data were imputed using multiple imputation (MI, MAR assumption) prior to running ANCOVA."|||<0.0001
72484719|NCT00728481|144497040|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|||Comparison between arms for a histologic response||||1.00
72484720|NCT00728481|144497045|SUPERIORITY_OR_OTHER|||||||0.76||95.0|||||Fisher Exact|||Comparison between arms for a symptomatic response||||0.76
72484721|NCT01505010|144497048|SUPERIORITY||Mean Difference (Final Values)|22.4|STANDARD_ERROR_OF_MEAN|8.5||0.018|TWO_SIDED||||||Mixed Models Analysis|Adjusted for the baseline 24-h systolic blood pressure|Difference at 6 months in 24-h systolic blood pressure (control minus intervention)|We used mixed models to compare blood pressure changes between randomized groups at 6 months, while adjusting for the baseline blood pressure; statistical significance was a P-value less than 0.05 on two-sided tests.||||0.018
72484722|NCT01505010|144497049|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|2.5|STANDARD_ERROR_OF_MEAN|4.87||0.86|TWO_SIDED||||||t-test, 2 sided|||Difference between control and intervention group at 6 months||||0.86
72484723|NCT01505010|144497050|SUPERIORITY||Median Difference (Final Values)|1.7||||0.032|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Wilcocon rank sum test||||0.032
72484724|NCT01505010|144497050|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|1.7|STANDARD_ERROR_OF_MEAN|0.8||0.032|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.032
72484725|NCT01910116|144497067|SUPERIORITY_OR_OTHER|||||||0.014|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Assuming that an improvement in AUSCAN pain score of \>10 is clinically meaningful, and assuming an alpha level of 0.05 (two-tailed), a power of 0.80, and a dropout rate of 20%, the sample size calculation revealed that 220 patients should be enrolled.||||0.014
72484726|NCT01910116|144497068|SUPERIORITY_OR_OTHER|||||||0.011|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.011
72484727|NCT01910116|144497069|SUPERIORITY_OR_OTHER|||||||0.053|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.053
72484728|NCT01910116|144497070|SUPERIORITY_OR_OTHER|||||||0.014|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.014
72484729|NCT01910116|144497071|SUPERIORITY_OR_OTHER|||||||0.728|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.728
72484730|NCT01910116|144497072|SUPERIORITY_OR_OTHER|||||||0.229|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.229
72484731|NCT01910116|144497073|SUPERIORITY_OR_OTHER|||||||0.194|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.194
72484732|NCT01910116|144497074|SUPERIORITY_OR_OTHER|||||||0.347|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.347
72484733|NCT01910116|144497075|SUPERIORITY_OR_OTHER|||||||0.122|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.122
72484734|NCT01910116|144497076|SUPERIORITY_OR_OTHER|||||||0.097|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.097
72484735|NCT01910116|144497078|SUPERIORITY_OR_OTHER|||||||0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.050
72576885|NCT00261443|144680707|SUPERIORITY_OR_OTHER_LEGACY|||||||0.64||95.0|||||Wilcoxon Rank Sum Test|||Baseline Treatment Comparison; Aripiprazole/Placebo||||0.640
72567410|NCT02696031|144665651|SUPERIORITY||||||<|0.0001||||||unadjusted p-value|Wilcoxon (Mann-Whitney)|The endpoint was analyzed by composite estimand strategy. Extreme unfavorable value is assigned for patients with treatment escape or missing data.||||||<.0001
72567411|NCT02696031|144665651|SUPERIORITY||||||<|0.0001||||||unadjusted p-value|Wilcoxon (Mann-Whitney)|The endpoint was analyzed by composite estimand strategy. Extreme unfavorable value is assigned for patients with treatment escape or missing data.||||||<.0001
72567412|NCT01843348|144665724|NON_INFERIORITY_OR_EQUIVALENCE|Analysis of variance (ANOVA) with tx, center, donor type factors. Raw and adjusted means were presented with one-sided p-values for un-shifted and shifted hypothesis, respectively. Significance level = 2.5% (one-sided)|Least square mean|-9.35|||<|0.0001|TWO_SIDED|95.0|-13.82|-4.88|||ANOVA|||The trial tests the null hypotheses that the treatment difference (investigational minus reference) in mean eGFR at re-assigned visit Month 12 is lower than the non-inferiority margin (Δ) of 7 mL/min per 1.73m2 versus the alternative that the treatment difference is equal to or greater than the non-inferiority margin||-4.88|-13.82|<0.0001
72567413|NCT01843348|144665724|NON_INFERIORITY_OR_EQUIVALENCE|The trial tests the null hypotheses that the treatment difference (investigational minus reference) in mean eGFR at re-assigned visit Month 12 is lower than the non-inferiority margin (Δ) of 7 mL/min per 1.73m2 versus the alternative that the treatment difference is equal to or greater than the non-inferiority margin|Least squares mean|-5.56||||0.0067|TWO_SIDED|95.0|-9.56|-1.55||Analysis of variance (ANOVA) with tx, center, donor type factors. Raw and adjusted means were presented with one-sided p-values for un-shifted and shifted hypothesis, respectively. Significance level = 2.5% (one-sided)|ANOVA|||||-1.55|-9.56|0.0067
72512196|NCT03725202|144554329|SUPERIORITY|Across the strata, 95% CI for adjusted difference and p-value are calculated according to the Cochran-Mantel-Haenszel test adjusted for strata (Baseline CS dose (prednisone or prednisolone \> 30 mg or ≤30 mg) and disease status (new onset or relapsing disease)) for the comparison of two treatment groups. Within each stratum, 95% CI for difference are calculated using normal approximation to the binomial distribution.|Adjusted Response Rate Difference|9.9|||=|0.0699|TWO_SIDED|95.0|-0.8|20.6|||Cochran-Mantel-Haenszel||Response rate difference = 7.5 mg Upadacitinib - Placebo|7.5 mg Upadacitinib + 26-week CS taper vs Placebo + 52-week CS taper||20.6|-0.8|=0.0699
72512197|NCT03725202|144554330|SUPERIORITY|P-value is based on the van Elteren test, adjusting for the strata (Baseline CS dose (prednisone or prednisolone \> 30 mg or ≤ 30 mg) and disease status (new onset or relapsing disease)).|||||<|0.0001|||||||van Elteren test|||15 mg Upadacitinib + 26-week CS taper vs Placebo + 52-week CS taper||||<0.0001
72512198|NCT03725202|144554330|SUPERIORITY|P-value is based on the van Elteren test, adjusting for the strata (Baseline CS dose (prednisone or prednisolone \> 30 mg or ≤ 30 mg) and disease status (new onset or relapsing disease)).|||||<|0.0001|||||||van Elteren test|||7.5 mg Upadacitinib + 26-week CS taper vs Placebo + 52-week CS taper||||<0.0001
72512199|NCT03725202|144554331|SUPERIORITY|Treatment comparisons in the distribution of time-to-event between each upadacitinib group and the placebo are conducted using stratified log-rank test stratified by stratification factors (Baseline CS dose (prednisone or prednisolone \> 30 mg or ≤ 30 mg) and disease status (new onset or relapsing disease). Within each stratum, 95% CI for difference are calculated using Cox proportional hazards model with stratification factors as covariates|Cox Proportional Hazard|0.57|||=|0.0025|TWO_SIDED|95.0|0.399|0.826|||Log-rank test|||15 mg Upadacitinib + 26-week CS taper vs Placebo + 52-week CS taper||0.826|0.399|=0.0025
72512200|NCT03725202|144554331|SUPERIORITY|Treatment comparisons in the distribution of time-to-event between each upadacitinib group and the placebo are conducted using stratified log-rank test stratified by stratification factors (Baseline CS dose (prednisone or prednisolone \> 30 mg or ≤ 30 mg) and disease status (new onset or relapsing disease). Within each stratum, 95% CI for difference are calculated using Cox proportional hazards model with stratification factors as covariates|Cox Proportional Hazard|0.75|||=|0.1778|TWO_SIDED|95.0|0.499|1.136|||Log-rank test|||7.5 mg Upadacitinib + 26-week CS taper vs Placebo + 52-week CS taper||1.136|0.499|=0.1778
72567414|NCT01843348|144665725|SUPERIORITY_OR_OTHER||Point estimate|0.032|||||TWO_SIDED|95.0|-0.029|0.093||||||TAC+Certican - TAC+MPA - difference between groups||0.093|-0.029|
72567415|NCT01843348|144665725|SUPERIORITY_OR_OTHER||Point estimate|0.149|||||TWO_SIDED|95.0|0.076|0.221||||||CycA+Certican -Tac+MPA - difference between groups||0.221|0.076|
72567416|NCT01843348|144665729|SUPERIORITY_OR_OTHER||Odds Ratio, log|0.028|||<|0.001|TWO_SIDED|95.0|-0.032|0.087|||Pearson's chi-square test|||BPAR - treatment differences at Month 12||0.087|-0.032|< 0.001
72567417|NCT02994355|144665750|SUPERIORITY||Prevalence rate ratio|1.33|||<|0.05|TWO_SIDED|95.0|1.16|1.52|||Poisson Regression|||||1.52|1.16|<0.05
72567418|NCT02994355|144665751|SUPERIORITY||Prevalence rate ratio|1.27|||<|0.05|TWO_SIDED|95.0|1.15|1.3|||Poisson regression|||||1.30|1.15|<0.05
72567419|NCT02994355|144665752|SUPERIORITY||Prevalence rate ratio|3.23|||<|0.05|TWO_SIDED|95.0|2.29|4.55|||Poisson regression|||||4.55|2.29|<0.05
72567420|NCT03832738|144665757|SUPERIORITY||Odds Ratio (OR)|1.5||||0.558|TWO_SIDED|95.0|0.39|5.8||p-value was estimated based on Cochran-Mantel-Haenszel test stratified by prior exposure to biologic therapy (Yes/No) and body weight (\<90 kg/≥90 kg).|Cochran-Mantel-Haenszel|||||5.80|0.39|0.558
72567421|NCT03832738|144665757|SUPERIORITY||Odds Ratio (OR)|3.74||||0.035|TWO_SIDED|95.0|1.07|13.1||p-value was estimated based on Cochran-Mantel-Haenszel test stratified by prior exposure to biologic therapy (Yes/No) and body weight (\<90 kg/≥90 kg).|Cochran-Mantel-Haenszel|||||13.10|1.07|0.035
72567422|NCT03832738|144665758|SUPERIORITY||Odds Ratio (OR)|2.26||||0.086|TWO_SIDED|95.0|0.89|5.75||p-value was estimated based on Cochran-Mantel-Haenszel test stratified by prior exposure to biologic therapy (Yes/No) and body weight (\<90 kg/≥90 kg).|Cochran-Mantel-Haenszel|||||5.75|0.89|0.086
72567423|NCT03832738|144665758|SUPERIORITY||Odds Ratio (OR)|3.76||||0.006|TWO_SIDED|95.0|1.45|9.75||p-value was estimated based on Cochran-Mantel-Haenszel test stratified by prior exposure to biologic therapy (Yes/No) and body weight (\<90 kg/≥90 kg).|Cochran-Mantel-Haenszel|||||9.75|1.45|0.006
72567424|NCT03832738|144665759|SUPERIORITY||Odds Ratio (OR)|1.0|||>|0.999|TWO_SIDED|95.0|0.06|17.25||p-value was estimated based on Cochran-Mantel-Haenszel test stratified by prior exposure to biologic therapy (Yes/No) and body weight (\<90 kg/≥90 kg).|Cochran-Mantel-Haenszel|||||17.25|0.06|>0.999
72567425|NCT03832738|144665759|SUPERIORITY||Odds Ratio (OR)|3.86||||0.244|TWO_SIDED|95.0|0.36|41.2||p-value was estimated based on Cochran-Mantel-Haenszel test stratified by prior exposure to biologic therapy (Yes/No) and body weight (\<90 kg/≥90 kg).|Cochran-Mantel-Haenszel|||||41.20|0.36|0.244
72484736|NCT01910116|144497079|SUPERIORITY_OR_OTHER|||||||0.031|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.031
72567426|NCT03832738|144665761|SUPERIORITY||Odds Ratio (OR)|5.21||||0.009|TWO_SIDED|95.0|1.38|19.62||p-value was estimated based on Cochran-Mantel-Haenszel test stratified by prior exposure to biologic therapy (Yes/No) and body weight (\<90 kg/≥90 kg).|Cochran-Mantel-Haenszel|||||19.62|1.38|0.009
72567427|NCT03832738|144665761|SUPERIORITY||Odds Ratio (OR)|7.35||||0.002|TWO_SIDED|95.0|1.86|29.08||p-value was estimated based on Cochran-Mantel-Haenszel test stratified by prior exposure to biologic therapy (Yes/No) and body weight (\<90 kg/≥90 kg).|Cochran-Mantel-Haenszel|||||29.08|1.86|0.002
72567428|NCT00703508|144665790|SUPERIORITY_OR_OTHER|||||||0.0234||||||Ovulation rate vs Testosterone post-treatment, threshold for statistical significance = p\<0.05|Regression, Linear|||||||0.0234
72567429|NCT00703508|144665790|SUPERIORITY_OR_OTHER|||||||0.074||||||Ovulation rate vs Testosterone post-treatment, threshold for statistical significance = p\<0.05|Regression, Linear|||||||0.0740
72567430|NCT00703508|144665790|SUPERIORITY_OR_OTHER|||||||0.4698||||||Ovulation rate vs Testosterone post-treatment, threshold for statistical significance = p\<0.05|Regression, Linear|||||||0.4698
72567431|NCT00703508|144665790|SUPERIORITY_OR_OTHER|||||||0.118||||||Ovulation rate vs Matsuda Index post-treatment, threshold for statistical significance = p \< 0.05.|Regression, Linear|||||||0.1180
72567432|NCT00703508|144665790|SUPERIORITY_OR_OTHER|||||||0.0311||||||Ovulation rate vs Matsuda Index post-treatment, threshold for statistical significance = p \< 0.05.|Regression, Linear|||||||0.0311
72567433|NCT00703508|144665790|SUPERIORITY_OR_OTHER|||||||0.1586||||||Ovulation rate vs Matsuda Index post-treatment, threshold for statistical significance = p \< 0.05.|Regression, Linear|||||||0.1586
72567434|NCT01064323|144665792|OTHER|Paired T-test to detect if there was a change from baseline to 5 minutes into intermittent pneumatic compression (IPC)||||||0.02|||||||Paired t-test|||||||0.02
72567435|NCT01064323|144665799|OTHER|||||||0.2|||||||t-test, 2 sided|||||||0.2
72567436|NCT01564459|144665819|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-0.587||||0.269|TWO_SIDED|95.0|-1.637|0.464|||Constrained longitudinal data analysis|terms for treatment, time and treatment-by-time interaction||||0.464|-1.637|0.269
72567437|NCT01564459|144665820|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-0.687||||0.108|TWO_SIDED|95.0|-1.527|0.154|||Constrained longitudinal data analysis|terms for treatment, time and treatment-by-time interaction||||0.154|-1.527|0.108
72567438|NCT00603291|144665873|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|3.14|||<|0.0001|TWO_SIDED|95.0|2.05|4.8|||Regression, Logistic|Adjustment for baseline body weight, baseline HbA1c stratum, and prior antihyperglycemic medication stratum||||4.80|2.05|<0.0001
72567439|NCT00603291|144665874|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.06|||<|0.0001|TWO_SIDED|95.0|-3.92|-2.2|||ANCOVA|||||-2.20|-3.92|<0.0001
72567440|NCT02246439|144665921|SUPERIORITY||Odds Ratio (OR)|1.6081||||0.0406|TWO_SIDED|95.0|1.0194|2.5368||"This P-Value is for the All ages group"|Cochran-Mantel-Haenszel|Stratified by age.||The odds ratio and p-value were from a Cochran-Mantel-Haenszel test. For the 'All ages' category, the odds ratio and p-value were stratified by age.||2.5368|1.0194|0.0406
72567441|NCT02246439|144665921|SUPERIORITY||Odds Ratio (OR)|4.8||||0.0729|TWO_SIDED|95.0|0.847|27.2024||"This P-Value is for the \<18 years of age group."|Cochran-Mantel-Haenszel|||||27.2024|0.8470|0.0729
72567442|NCT02246439|144665921|SUPERIORITY||Odds Ratio (OR)|1.4755||||0.1089|TWO_SIDED|95.0|0.917|2.3741||"This P-Value is for the 18 years of age and older group"|Cochran-Mantel-Haenszel|||||2.3741|0.9170|0.1089
72567443|NCT02246439|144665922|SUPERIORITY||Odds Ratio (OR)|1.3545||||0.1843|TWO_SIDED|95.0|0.8647|2.1216|||Cochran-Mantel-Haenszel|Stratified by age.||||2.1216|0.8647|0.1843
72567444|NCT02246439|144665923|SUPERIORITY||Odds Ratio (OR)|1.752||||0.0166|TWO_SIDED|95.0|1.1058|2.776|||Cochran-Mantel-Haenszel|Stratified by age.||||2.7760|1.1058|0.0166
72567445|NCT02246439|144665924|SUPERIORITY||Odds Ratio (OR)|0.6677||||0.1049|TWO_SIDED|95.0|0.4093|1.0892|||Cochran-Mantel-Haenszel|Stratified by age.||||1.0892|0.4093|0.1049
72484737|NCT01910116|144497080|SUPERIORITY_OR_OTHER|||||||0.021|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.021
72567446|NCT02246439|144665925|SUPERIORITY||Odds Ratio (OR)|0.6566||||0.1235|TWO_SIDED|95.0|0.3826|1.1268|||Cochran-Mantel-Haenszel|Stratified by age.||||1.1268|0.3826|0.1235
72567447|NCT02246439|144665927|SUPERIORITY|||||||0.589||||||This P-Value is for the BSS=7 group.|Wilcoxon (Mann-Whitney)|||||||0.5890
72567448|NCT02246439|144665928|SUPERIORITY||Hazard Ratio (HR)|0.9782||||0.8487|TWO_SIDED|95.0|0.7803|1.2264||"This P-Value is for the All ages group."|Cox proportioanl hazards method|Stratified by age.||||1.2264|0.7803|0.8487
72567449|NCT02246439|144665928|SUPERIORITY||Hazard Ratio (HR)|1.4756||||0.3479|TWO_SIDED|95.0|0.6549|3.325||"This P-Value is for the \<18 years of age group."|Cox proportional hazards method|||||3.3250|0.6549|0.3479
72567450|NCT02246439|144665928|SUPERIORITY||Hazard Ratio (HR)|0.9445||||0.6332|TWO_SIDED|95.0|0.7469|1.1943||"This P-Value is for the 18 years of age of older group."|Cox proportional hazards method|||||1.1943|0.7469|0.6332
72567451|NCT02246439|144665929|SUPERIORITY||Hazard Ratio (HR)|1.0275||||0.8289|TWO_SIDED|95.0|0.8036|1.3138||"This P-Value was for the All ages group."|Cox proportional hazards method|Stratified by age.||||1.3138|0.8036|0.8289
72567452|NCT02246439|144665929|SUPERIORITY||Hazard Ratio (HR)|1.5744||||0.3241|TWO_SIDED|95.0|0.6388|3.8802||"This P-Value is for the \<18 years of age group."|Cox proportional hazards method|||||3.8802|0.6388|0.3241
72484738|NCT01910116|144497081|SUPERIORITY_OR_OTHER|||||||0.049|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.049
72484739|NCT01910116|144497082|SUPERIORITY_OR_OTHER|||||||0.221|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.221
72484740|NCT01910116|144497083|SUPERIORITY_OR_OTHER|||||||0.174|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.174
72484741|NCT01910116|144497084|SUPERIORITY_OR_OTHER|||||||0.124|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.124
72484742|NCT01910116|144497085|SUPERIORITY_OR_OTHER|||||||0.128|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.128
72484743|NCT01910116|144497086|SUPERIORITY_OR_OTHER|||||||0.126|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.126
72484744|NCT01910116|144497087|SUPERIORITY_OR_OTHER|||||||0.042|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.042
72484745|NCT01910116|144497088|SUPERIORITY_OR_OTHER|||||||0.66|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.660
72484746|NCT01910116|144497089|SUPERIORITY_OR_OTHER|||||||0.006|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.006
72484747|NCT01910116|144497090|SUPERIORITY_OR_OTHER|||||||0.186|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.186
72484748|NCT01910116|144497091|SUPERIORITY_OR_OTHER|||||||0.493|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.493
72484749|NCT01910116|144497092|SUPERIORITY_OR_OTHER|||||||0.062|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.062
72484750|NCT01910116|144497093|SUPERIORITY_OR_OTHER|||||||0.604|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.604
72484751|NCT01910116|144497094|SUPERIORITY_OR_OTHER|||||||0.252|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.252
72484752|NCT01910116|144497095|SUPERIORITY_OR_OTHER|||||||0.378|TWO_SIDED||||||Chi-squared|||||||0.378
72484753|NCT01910116|144497096|SUPERIORITY_OR_OTHER|||||||0.485|TWO_SIDED||||||Chi-squared|||||||0.485
72484754|NCT01910116|144497097|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Fisher Exact|||||||1.000
72484755|NCT01910116|144497098|SUPERIORITY_OR_OTHER|||||||0.683|TWO_SIDED||||||Fisher Exact|||||||0.683
72484756|NCT01910116|144497099|SUPERIORITY_OR_OTHER|||||||0.036|TWO_SIDED||||||Chi-squared|||||||0.036
72484757|NCT01910116|144497100|SUPERIORITY_OR_OTHER|||||||0.022|TWO_SIDED||||||Chi-squared|||||||0.022
72484758|NCT01910116|144497101|SUPERIORITY_OR_OTHER|||||||0.017|TWO_SIDED||||||Chi-squared|||||||0.017
72484759|NCT01910116|144497102|SUPERIORITY_OR_OTHER|||||||0.06|TWO_SIDED||||||Chi-squared|||||||0.060
72484760|NCT03606980|144497103|EQUIVALENCE|p\<0.05 was considered statistically significant. A 95% confidence interval was computed using logistic regression model.|Hazard Ratio (HR)|3.11||||0.0366|TWO_SIDED|95.0|1.073|9.005|||Cox proportional hazards analysis|||||9.005|1.073|0.0366
72484761|NCT03606980|144497103|EQUIVALENCE|p\<0.05 was considered statistically significant.|Hazard Ratio (HR)|4.16||||0.0232|TWO_SIDED|95.0|1.215|14.273|||Cox proportional hazards analysis|||||14.273|1.215|0.0232
72484762|NCT03606980|144497103|EQUIVALENCE|p\<0.05 was considered statistically significant.|Hazard Ratio (HR)|1.24||||0.64|TWO_SIDED|95.0|0.389|4.615|||Cox proportional hazards analysis|||||4.615|0.389|0.64
72484763|NCT03606980|144497104|EQUIVALENCE|All statistical tests were two-sided, and p\<0.05 was considered statistically significant.||||||0.86|||||||ANOVA|||||||0.86
72484764|NCT03606980|144497105|EQUIVALENCE|p\<00.05 was considered statistically significant.||||||0.25|||||||ANOVA|||||||0.25
72484765|NCT03606980|144497106|EQUIVALENCE|p\<0.05 considered statistically significant.||||||0.29|||||||ANOVA|||||||0.29
72484766|NCT03606980|144497107|EQUIVALENCE|All statistical tests were performed using the SAS Studio. All statistical tests were two-sided, and p\<0.05 was considered statistically significant.||||||0.57|||||||ANOVA|||||||0.57
72484767|NCT02469896|144497111|SUPERIORITY||Risk Ratio (RR)|0.875||||0.602|TWO_SIDED|95.0|0.556|1.377|||Fisher Exact|||||1.377|0.556|0.602
72484768|NCT02469896|144497112|SUPERIORITY||||||||||||||||||No statistical data was obtain because no patients died during the trial.|||
72484769|NCT02469896|144497113|SUPERIORITY||Slope|0.099||||0.922|TWO_SIDED|95.0|-1.902|2.099||Unadjusted|Mixed Models Analysis|||||2.099|-1.902|0.922
72484770|NCT02469896|144497114|SUPERIORITY||Difference of slopes|-0.008||||0.983|TWO_SIDED|95.0|-0.761|0.745|||Mixed Models Analysis|||||0.745|-0.761|0.983
72484771|NCT02469896|144497116|SUPERIORITY||Ratio of geometric means|1.15||||0.684|TWO_SIDED|95.0|0.566|2.337|||t-test, 2 sided|||PBMC IL-6 fold-change||2.337|0.566|0.684
72484772|NCT02469896|144497116|SUPERIORITY||Ratio of geometric means|1.344||||0.663|TWO_SIDED|95.0|0.331|2.08|||t-test, 2 sided|||||2.080|0.331|0.663
72484773|NCT02469896|144497116|SUPERIORITY||Ratio of geometric means|1.198||||0.5|TWO_SIDED|95.0|0.691|2.08|||t-test, 2 sided|||||2.080|0.691|0.500
72484774|NCT02469896|144497117|SUPERIORITY||Ratio of fold change|0.047|||<|0.001|TWO_SIDED|95.0|0.01|0.217|||Mixed Models Analysis|||||0.217|0.010|<0.001
72484775|NCT02469896|144497117|SUPERIORITY||Ratio of fold change|1.306||||0.247|TWO_SIDED|95.0|0.828|2.059|||Mixed Models Analysis|||||2.059|0.828|0.247
72484776|NCT02469896|144497117|SUPERIORITY||Ratio of fold change|19.591|||<|0.001|TWO_SIDED|95.0|11.143|34.446|||Mixed Models Analysis|||||34.446|11.143|<0.001
72484777|NCT02469896|144497117|SUPERIORITY||Ratio of fold change|1.264||||0.185|TWO_SIDED|95.0|0.892|1.791|||Mixed Models Analysis|||||1.791|0.892|0.185
72484778|NCT02469896|144497117|SUPERIORITY||Ratio of fold change|1.396||||0.427|TWO_SIDED|95.0|0.608|3.206|||Mixed Models Analysis|||||3.206|0.608|0.427
72484779|NCT02469896|144497117|SUPERIORITY||Ratio of fold change|0.893||||0.285|TWO_SIDED|95.0|0.725|1.1|||Mixed Models Analysis|||||1.100|0.725|0.285
72484780|NCT02469896|144497118|SUPERIORITY||Ratio of fold change|0.167||||0.011|TWO_SIDED|95.0|0.043|0.643|||Mixed Models Analysis|||||0.643|0.043|0.011
72484781|NCT02469896|144497118|SUPERIORITY||Ratio of fold change|0.741||||0.604|TWO_SIDED|95.0|0.228|2.405|||Mixed Models Analysis|||||2.405|0.228|0.604
72484782|NCT02469896|144497118|SUPERIORITY||Ratio of fold change|2.94|||<|0.001|TWO_SIDED|95.0|1.823|4.74|||Mixed Models Analysis|||||4.740|1.823|<0.001
72484783|NCT02469896|144497118|SUPERIORITY||Ratio of fold change|1.078||||0.587|TWO_SIDED|95.0|0.813|1.431|||Mixed Models Analysis|||||1.431|0.813|0.587
72402487|NCT01480076|144311682|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Overall, RRMS. Mixed effect model for repeated measures with visit, baseline of the current health state of EQ-5D scores, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
72484784|NCT02469896|144497118|SUPERIORITY||Ratio of fold change|1.078||||0.697|TWO_SIDED|95.0|0.728|1.595|||Mixed Models Analysis|||||1.595|0.728|0.697
72484785|NCT02469896|144497119|SUPERIORITY||Ratio of fold change|1.785|||<|0.001|TWO_SIDED|95.0|1.502|2.121|||Mixed Models Analysis|||||2.121|1.502|<0.001
72484786|NCT01294150|144497122|SUPERIORITY_OR_OTHER|||||||0.003|TWO_SIDED|||||Assuming unequal variances comparing mean improvement in the UL group to 125% of the mean improvement in the Control group. A p-value of 0.025 or less associated with UL is considered evidence of statistical significance|t-test, 2 sided|||||||0.003
72484787|NCT05315947|144497222|EQUIVALENCE|Bioequivalence between the BRV tablet (reference) and BRV dry syrup (test) formulations were concluded if the 90% CI limits for Cmax was within the 0.80 to 1.25 range.|Ratio of Dry Syrup/ Tablet|0.87|||||TWO_SIDED|90.0|0.7814|0.9686||||||||0.9686|0.7814|
72484788|NCT05315947|144497223|EQUIVALENCE|Bioequivalence between the BRV tablet (reference) and BRV dry syrup (test) formulations were concluded if the 90% CI limits for AUC(0-t) was within the 0.80 to 1.25 range.|Ratio of Dry Syrup/ Tablet|0.989|||||TWO_SIDED|90.0|0.9756|1.003||||||||1.003|0.9756|
72484789|NCT01624259|144497231|NON_INFERIORITY_OR_EQUIVALENCE|"Family-wise Type I error rate was controlled by applying a serial gatekeeping strategy.~This calculation assumed a 0 difference in HbA1c between the 1.5 mg LY2189265 1.5-mg arm and 1.8 mg liraglutide, 0.4% margin of noninferiority, common Standard Deviation (SD) of 1.3% for change from baseline in HbA1c, 0.05 two-sided significance level, and 25% dropout rate at 26 weeks."|LS Mean Difference|-0.06|||<|0.001|TWO_SIDED|95.0|-0.19|0.07||1-sided raw p-value (no multiplicity adjustment).|Mixed Models Analysis|||To show noninferiority of 1.5 mg LY2189265 relative to 1.8 mg liraglutide with 90% power, 222 completers (444 total) at 26 weeks were required. Noninferiority of 1.5 mg LY2189265 relative to 1.8 mg liraglutide was demonstrated if the upper bound of the two-sided 95% Confidence Interval (CI) for the difference in mean change in HbA1c between the 1.5 mg LY2189265 arm and 1.8 mg liraglutide arm was below 0.4%.||0.07|-0.19|<0.001
72484790|NCT01624259|144497231|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.06||||0.186|TWO_SIDED|95.0|-0.19|0.07||1-sided raw p-value (no multiplicity adjustment)|Mixed Models Analysis|||Superiority analysis||0.07|-0.19|0.186
72484791|NCT01624259|144497232|SUPERIORITY_OR_OTHER||LS Mean Difference|0.71|STANDARD_ERROR_OF_MEAN|0.28||0.01|TWO_SIDED|95.0|0.17|1.26||No adjustment for multiplicity.|ANCOVA|||Treatment comparison from ANCOVA model at 26 weeks.||1.26|0.17|0.010
72484792|NCT01624259|144497233|SUPERIORITY_OR_OTHER||LS Mean Difference|0.25|STANDARD_ERROR_OF_MEAN|0.1||0.013|TWO_SIDED|95.0|0.05|0.45||No adjustment for multiplicity.|ANCOVA|||Treatment comparison from ANCOVA model.||0.45|0.05|0.013
72484793|NCT01624259|144497234|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.57|STANDARD_ERROR_OF_MEAN|2.61||0.828|TWO_SIDED|95.0|-5.69|4.56||No adjustment for multiplicity.|ANCOVA|||Treatment comparison from ANCOVA model.||4.56|-5.69|0.828
72484794|NCT01624259|144497235|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.25|STANDARD_ERROR_OF_MEAN|1.86||0.228|TWO_SIDED|95.0|-5.91|1.41||No adjustment for multiplicity.|Mixed Models Analysis|P-value from pairwise comparison of LS means at 26 weeks from REML-based MMRM.||||1.41|-5.91|0.228
72484795|NCT01624259|144497236|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.23||||0.322|TWO_SIDED|95.0|0.81|1.86||P-value of treatment comparison at Week 26 is from repeated generalized linear mixed model (GLM model).|Regression, Logistic|No adjustment for multiplicity.||Treatment comparison for HbA1c levels ≤6.5%||1.86|0.81|0.322
72484796|NCT01624259|144497236|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.02||||0.925|TWO_SIDED|95.0|0.64|1.63||No adjustment for multiplicity.|Regression, Logistic|P-value of treatment comparison at Week 26 is from repeated generalized linear mixed model (GLM model).||Treatment comparison for HbA1c levels \<7.0%.||1.63|0.64|0.925
72484797|NCT01624259|144497237|SUPERIORITY_OR_OTHER||LS Mean Difference|1.43|STANDARD_ERROR_OF_MEAN|2.79||0.608|TWO_SIDED|95.0|-4.06|6.92|||ANCOVA|No adjustment for multiplicity.||||6.92|-4.06|0.608
72484798|NCT02113579|144497382|SUPERIORITY_OR_OTHER||Success rate difference (%)|24.7|||<|0.001|TWO_SIDED|||||Per statistical analysis plan, if experimental rinse was significantly better than placebo (p\<0.05) with estimated difference of \>= 20%, testing proceeded to Mean Cold Air Stimulus VAS Score at Week 4. Family-wise error was controlled at 0.05.|Regression, Logistic|Study center and mean baseline cold air stimulus VAS score as covariate. For subjects with no score at Week 4, non-response was imputed.|Estimated by calculating the model predicted success probabilities assuming all subjects received 12027-033 and then assuming all subjects received placebo, and then calculating mean of subjects' differences between these predicted probabilities.|The null hypothesis was no difference in success rates between treatment groups. The alternative hypothesis was a difference in success rates between treatment groups.||||<0.001
72484799|NCT02113579|144497383|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-14.27|STANDARD_ERROR_OF_MEAN|2.239|<|0.001|TWO_SIDED|95.0|-18.68|-9.87||Per statistical analysis plan, if experimental rinse was significantly better than placebo (p\<0.05), testing proceeded to Mean Tactile Sensitivity Score at Week 4. Family-wise error was controlled at 0.05.|Repeated Measures Model|Analysis included Weeks 2 and 4 data. Terms included treatment, visit, study center, baseline value, treatment-by-visit and baseline-by-visit.|For subjects without post-baseline data, the baseline value was carried forward to Week 2. An unstructured covariance pattern was assumed.|The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-9.87|-18.68|<0.001
72512201|NCT03725202|144554332|SUPERIORITY|The point estimate of flare rate at Week 52 from the Kaplan-Meier estimate for each stratum is used to derive the stratified disease flare rate. P-value, and 95% CI for the odds ratio between each upadacitinib group and placebo is also provided. Stratification factors (Baseline CS dose (prednisone or prednisolone \> 30 mg or ≤ 30 mg) and disease status (new onset or relapsing disease) were used.|Odds Ratio (OR)|0.47|||=|0.0014|TWO_SIDED|95.0|0.29|0.74|||Stratified Test for Odds Ratio|This method is described in J Immunother Cancer. 2021 Nov;9(11):e003323. doi: 10.1136/jitc-2021-003323.||15 mg Upadacitinib + 26-week CS taper vs Placebo + 52-week CS taper||0.74|0.29|=0.0014
72567453|NCT02246439|144665929|SUPERIORITY||Hazard Ratio (HR)|0.992||||0.9511|TWO_SIDED|95.0|0.7688|1.2801||"This P-Value is for the 18 years of age or older group."|Cox proportional hazards method|||||1.2801|0.7688|0.9511
72567454|NCT02246439|144665930|SUPERIORITY||Odds Ratio (OR)|2.3012||||0.2005|TWO_SIDED|95.0|0.6221|8.5129|||Cochran-Mantel-Haenszel|||||8.5129|0.6221|0.2005
72567455|NCT02246439|144665931|SUPERIORITY||Odds Ratio (OR)|0.6674||||0.572|TWO_SIDED|95.0|0.1638|2.7191|||Cochran-Mantel-Haenszel|||||2.7191|0.1638|0.5720
72567456|NCT02246439|144665932|SUPERIORITY||Odds Ratio (OR)|2.1591||||0.3186|TWO_SIDED|95.0|0.477|9.7735||"This P-Value is for the No nausea or mild nausea group."|Cochran-Mantel-Haenszel|Stratified by age.||||9.7735|0.4770|0.3186
72484800|NCT02113579|144497384|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|13.45|STANDARD_ERROR_OF_MEAN|1.844|<|0.001|TWO_SIDED|95.0|9.83|17.08||Per statistical analysis plan, if experimental rinse was significantly better than placebo (p\<0.05), testing proceeded to Mean Cold Air Stimulus VAS Score at Week 2 and Mean Tactile Sensitivity Score at Week 2. Family-wise error controlled at 0.05.|Repeated Measures Model|Analysis included Weeks 2 and 4 data. Terms included treatment, visit, study center, baseline value, treatment-by-visit and baseline-by-visit.|For subjects without post-baseline data, the baseline value was carried forward to Week 2. An unstructured covariance pattern was assumed.|The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||17.08|9.83|<0.001
72512202|NCT03725202|144554332|SUPERIORITY|The point estimate of flare rate at Week 52 from the Kaplan-Meier estimate for each stratum is used to derive the stratified disease flare rate. P-value, and 95% CI for the odds ratio between each upadacitinib group and placebo is also provided. Stratification factors (Baseline CS dose (prednisone or prednisolone \> 30 mg or ≤ 30 mg) and disease status (new onset or relapsing disease) were used.|Odds Ratio (OR)|0.6|||=|0.0633|TWO_SIDED|95.0|0.35|1.03|||Stratified Test for Odds Ratio|This method is described in J Immunother Cancer. 2021 Nov;9(11):e003323. doi: 10.1136/jitc-2021-003323.||7.5 mg Upadacitinib + 26-week CS taper vs Placebo + 52-week CS taper||1.03|0.35|=0.0633
72512203|NCT03725202|144554333|SUPERIORITY|Across the strata, 95% CI for adjusted difference and p-value are calculated according to the Cochran-Mantel-Haenszel test adjusted for strata (Baseline CS dose (prednisone or prednisolone \> 30 mg or ≤30 mg) and disease status (new onset or relapsing disease)) for the comparison of two treatment groups. Within each stratum, 95% CI for difference are calculated using normal approximation to the binomial distribution.|Adjusted Response Rate Difference|30.3|||<|0.0001|TWO_SIDED|95.0|20.4|40.2|||Cochran-Mantel-Haenszel|||15 mg Upadacitinib + 26-week CS taper vs Placebo + 52-week CS taper||40.2|20.4|<0.0001
72512204|NCT03725202|144554333|SUPERIORITY|Across the strata, 95% CI for adjusted difference and p-value are calculated according to the Cochran-Mantel-Haenszel test adjusted for strata (Baseline CS dose (prednisone or prednisolone \> 30 mg or ≤30 mg) and disease status (new onset or relapsing disease)) for the comparison of two treatment groups. Within each stratum, 95% CI for difference are calculated using normal approximation to the binomial distribution.|Adjusted Response Rate Difference|23.5|||<|0.0001|TWO_SIDED|95.0|11.7|35.3|||Cochran-Mantel-Haenszel|||7.5 mg Upadacitinib + 26-week CS taper vs Placebo + 52-week CS taper||35.3|11.7|<0.0001
72512205|NCT03725202|144554334|SUPERIORITY|Across the strata, 95% CI for adjusted difference and p-value are calculated according to the Cochran-Mantel-Haenszel test adjusted for strata (Baseline CS dose (prednisone or prednisolone \> 30 mg or ≤30 mg) and disease status (new onset or relapsing disease)) for the comparison of two treatment groups. Within each stratum, 95% CI for difference are calculated using normal approximation to the binomial distribution.|Adjusted Response Rate Difference|20.8|||=|0.0002|TWO_SIDED|95.0|9.7|31.9|||Cochran-Mantel-Haenszel|||15 mg Upadacitinib + 26-week CS taper vs Placebo + 52-week CS taper||31.9|9.7|=0.0002
72512206|NCT03725202|144554334|SUPERIORITY|Across the strata, 95% CI for adjusted difference and p-value are calculated according to the Cochran-Mantel-Haenszel test adjusted for strata (Baseline CS dose (prednisone or prednisolone \> 30 mg or ≤30 mg) and disease status (new onset or relapsing disease)) for the comparison of two treatment groups. Within each stratum, 95% CI for difference are calculated using normal approximation to the binomial distribution.|Adjusted Response Rate Difference|3.2|||=|0.6276|TWO_SIDED|95.0|-9.6|16.0|||Cochran-Mantel-Haenszel|||7.5 mg Upadacitinib + 26-week CS taper vs Placebo + 52-week CS taper||16.0|-9.6|=0.6276
72567457|NCT02246439|144665932|SUPERIORITY||Odds Ratio (OR)|1.575||||0.3473|TWO_SIDED|95.0|0.6096|4.0696||"This P-Value is for the Moderate nausea group."|Cochran-Mantel-Haenszel|Stratified by age.||||4.0696|0.6096|0.3473
72567458|NCT02246439|144665932|SUPERIORITY||Odds Ratio (OR)|2.0971||||0.0633|TWO_SIDED|95.0|0.9614|4.5747||"This P-Value is for the Severe nausea group."|Cochran-Mantel-Haenszel|Stratified by age.||||4.5747|0.9614|0.0633
72567459|NCT02246439|144665932|SUPERIORITY||Odds Ratio (OR)|1.6397||||0.2797|TWO_SIDED|95.0|0.6649|4.0437||"This P-Value is for the Nausea as bad as it could have been group."|Cochran-Mantel-Haenszel|Stratified by age.||||4.0437|0.6649|0.2797
72567460|NCT02246439|144665933|SUPERIORITY||Odds Ratio (OR)|1.8673||||0.0103|TWO_SIDED|95.0|1.1572|3.0131||"This P-Value is for the All ages group."|Cochran-Mantel-Haenszel|Stratified by age.||||3.0131|1.1572|0.0103
72567461|NCT02246439|144665933|SUPERIORITY||Odds Ratio (OR)|4.4||||0.0934|TWO_SIDED|95.0|0.7699|25.145||"This P-Value is for the \<18 years of age group."|Cochran-Mantel-Haenszel|||||25.1450|0.7699|0.0934
72567462|NCT02246439|144665933|SUPERIORITY||Odds Ratio (OR)|1.7356||||0.0303|TWO_SIDED|95.0|1.0527|2.8615||"This P-Value is for the 18 years of age or older group."|Cochran-Mantel-Haenszel|||||2.8615|1.0527|0.0303
72567463|NCT02246439|144665934|SUPERIORITY||Odds Ratio (OR)|4.4||||0.0924|TWO_SIDED|95.0|0.7699|25.145||"This P-Value is for the \<18 years of age group."|Cochran-Mantel-Haenszel|||||25.1450|0.7699|0.0924
72567464|NCT02246439|144665934|SUPERIORITY||Odds Ratio (OR)|1.7356||||0.0303|TWO_SIDED|95.0|1.0527|2.8615||"This P-Value is for the 18 years of age or older group."|Cochran-Mantel-Haenszel|||||2.8615|1.0527|0.0303
72567465|NCT02246439|144665935|SUPERIORITY||Odds Ratio (OR)|1.7922||||0.0152|TWO_SIDED|95.0|1.1188|2.871|||Regression, Logistic|||||2.8710|1.1188|0.0152
72567466|NCT02246439|144665936|SUPERIORITY||Odds Ratio (OR)|2.0789||||0.0037|TWO_SIDED|95.0|1.2676|3.4095|||Regression, Logistic|||||3.4095|1.2676|0.0037
72567467|NCT02130583|144666028|SUPERIORITY||Mean Difference (Net)|2.06||||0.034|TWO_SIDED||||||ANOVA|||||||.034
72567468|NCT03247517|144666040|SUPERIORITY||Least Square Mean Difference|-4.5|STANDARD_ERROR_OF_MEAN|1.98||0.0232|TWO_SIDED|95.0|-8.4|-0.6|||Mixed Models for Repeated Measures|||||-0.6|-8.4|0.0232
72402488|NCT01480076|144311682|SUPERIORITY_OR_OTHER|||||||0.0005|||||||mixed effect model|||Overall, SPMS. Mixed effect model for repeated measures with visit, baseline of the current health state of EQ-5D scores, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0005
72484801|NCT02113579|144497385|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-7.67|STANDARD_ERROR_OF_MEAN|1.809|<|0.001|TWO_SIDED|95.0|-11.23|-4.11||Per statistical analysis plan, Hochberg's method at significance level 0.05 was applied to jointly evaluate secondary outcomes Mean Cold Air Stimulus VAS Score at Wk 2 and Mean Tactile Sensitivity Score at Wk 2. Family-wise error controlled at 0.05.|Repeated Measures Model|Analysis included Weeks 2 and 4 data. Terms included treatment, visit, study center, baseline value, treatment-by-visit and baseline-by-visit.|For subjects without post-baseline data, the baseline value was carried forward to Week 2. An unstructured covariance pattern was assumed.|The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-4.11|-11.23|<0.001
72484802|NCT02113579|144497386|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|4.7|STANDARD_ERROR_OF_MEAN|0.975|<|0.001|TWO_SIDED|95.0|2.78|6.62||Per statistical analysis plan, Hochberg's method at significance level 0.05 was applied to jointly evaluate secondary outcomes Mean Cold Air Stimulus VAS Score at Wk 2 and Mean Tactile Sensitivity Score at Wk 2. Family-wise error controlled at 0.05.|Repeated Measures Model|Analysis included Weeks 2 and 4 data. Terms included treatment, visit, study center, baseline value, treatment-by-visit and baseline-by-visit.|For subjects without post-baseline data, the baseline value was carried forward to Week 2. An unstructured covariance pattern was assumed.|The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||6.62|2.78|<0.001
72484803|NCT02113579|144497387|SUPERIORITY_OR_OTHER||Success rate difference (%)|15.44||||0.002|TWO_SIDED|||||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|Regression, Logistic|Study center and mean baseline cold air stimulus VAS score as covariate. For subjects with no score at Week 2, non-response was imputed.|Estimated by calculating the model predicted success probabilities assuming all subjects received 12027-033 and then assuming all subjects received placebo, and then calculating mean of subjects' differences between these predicted probabilities.|The null hypothesis was no difference in success rates between treatment groups. The alternative hypothesis was a difference in success rates between treatment groups.||||0.002
72484804|NCT02113579|144497388|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-6.67|STANDARD_ERROR_OF_MEAN|1.65|<|0.001|TWO_SIDED|95.0|-9.92|-3.43||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|Repeated Measures Model|Analysis included Weeks 2 and 4 data. Terms included treatment, visit, study center, baseline value, treatment-by-visit and baseline-by-visit.|For subjects without post-baseline data, the baseline value was carried forward to Week 2. An unstructured covariance pattern was assumed.|The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-3.43|-9.92|<0.001
72484805|NCT02113579|144497389|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-11.52|STANDARD_ERROR_OF_MEAN|1.92|<|0.001|TWO_SIDED|95.0|-15.3|-7.75||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|Repeated Measures Model|Analysis included Weeks 2 and 4 data. Terms included treatment, visit, study center, baseline value, treatment-by-visit and baseline-by-visit.|For subjects without post-baseline data, the baseline value was carried forward to Week 2. An unstructured covariance pattern was assumed.|The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-7.75|-15.30|<0.001
72484806|NCT02113579|144497390|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-3.24|STANDARD_ERROR_OF_MEAN|1.422||0.023|TWO_SIDED|95.0|-6.04|-0.45||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|Repeated Measures Model|Analysis included Weeks 2 and 4 data. Terms included treatment, visit, study center, baseline value, treatment-by-visit and baseline-by-visit.|For subjects without post-baseline data, the baseline value was carried forward to Week 2. An unstructured covariance pattern was assumed.|The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-0.45|-6.04|0.023
72484807|NCT02113579|144497391|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-7.61|STANDARD_ERROR_OF_MEAN|1.873|<|0.001|TWO_SIDED|95.0|-11.29|-3.93||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|Repeated Measures Model|Analysis included Weeks 2 and 4 data. Terms included treatment, visit, study center, baseline value, treatment-by-visit and baseline-by-visit.|For subjects without post-baseline data, the baseline value was carried forward to Week 2. An unstructured covariance pattern was assumed.|The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups||-3.93|-11.29|<0.001
72484808|NCT00594516|144497394|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin of (-2, 2). A prespecified equivalence margin of (-2,2) was used for equivalence analysis.|Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.09||||95.0|-0.09|0.28||||||Comparison of Tapentadol IR to ER analysis of variance model with factors for treatment, double blind cross-over period and subject.||0.28|-0.09|
72484809|NCT02217436|144497399|SUPERIORITY|||||||0.98|||||||Wilcoxon (Mann-Whitney)|||||||0.98
72484810|NCT02217436|144497400|SUPERIORITY|||||||0.01|||||||Wilcoxon (Mann-Whitney)|||||||0.01
72484811|NCT02039726|144497426|OTHER||Hazard Ratio (HR)|0.758||||0.0185|TWO_SIDED|95.0|0.584|0.983|||P-value for HR=1 (1-sided)|||Stratified analysis - stratification factors include prior therapy and response (Relapsed in ≤6 months (not post-HSCT), Refractory, or relapsed in ≤6 months post allogeneic HSCT), and pre-selected chemotherapy (High intensity chemotherapy \[MEC or FLAG-IDA\], or low intensity chemotherapy \[LoDAC\]).||0.983|0.584|0.0185
72484812|NCT02039726|144497427|OTHER||Hazard Ratio (HR)|0.898||||0.2034|TWO_SIDED|95.0|0.697|1.157|||P value for HR=1 (1-sided)|||Stratified analysis - stratification factors include prior therapy and response (Relapsed in ≤6 months (not post-HSCT), Refractory, or relapsed in ≤6 months post allogeneic HSCT), and pre-selected chemotherapy (High intensity chemotherapy \[MEC or FLAG-IDA\], or low intensity chemotherapy \[LoDAC\]).||1.157|0.697|0.2034
72512207|NCT03725202|144554335|SUPERIORITY|The Mixed-Effect Model Repeat Measurement with Baseline value, categorical fixed effects of treatment, visit and treatment-by-visit interaction, stratification factors at randomization (Baseline CS dose (prednisone or prednisolone \>30 mg, prednisone or prednisolone ≤30 mg) and Baseline disease status (new onset disease, relapsing disease)) included in the model. An unstructured variance covariance matrix is used. Data after initiation of corticosteroid escape therapy are excluded from the model.|LS Mean Difference|3.7526|STANDARD_ERROR_OF_MEAN|1.1981|=|0.0019|TWO_SIDED|95.0|1.3932|6.1119|||Mixed-Effect Model Repeat Measurement||Difference = 15 mg Upadacitinib - Placebo|15 mg Upadacitinib + 26-week CS taper vs Placebo + 52-week CS taper||6.1119|1.3932|=0.0019
72484813|NCT00813319|144497439|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Chi-squared|||This comparison is for participants in the Girls OnGuard/HPV Awareness condition compared to the General Health Promotion condition||||>.05
72484814|NCT00813319|144497440|SUPERIORITY_OR_OTHER||||||=|0.52|||||||Chi-squared|||||||=.52
72484815|NCT00813319|144497441|SUPERIORITY_OR_OTHER||||||=|0.12|||||||Chi-squared|Degrees of freedom = 2||This comparison is for total doses received (26 in Girls OnGuard/HPV Awareness condition compared to 17 in General Health Promotion condition)||||=.12
72484816|NCT01448213|144497442|SUPERIORITY_OR_OTHER|||||||0.17|||||||Log Rank|||||||0.17
72484817|NCT01448213|144497443|SUPERIORITY_OR_OTHER|||||||0.0005|||||||Log Rank|||||||0.0005
72484818|NCT02012296|144497444|SUPERIORITY|||||||0.83|||||||Log Rank|||||||0.83
72484819|NCT02012296|144497445|SUPERIORITY|||||||0.21|||||||Log Rank|||||||0.21
72484820|NCT02012296|144497448|SUPERIORITY|||||||0.0012|||||||t-test, 2 sided|||||||0.0012
72512208|NCT03725202|144554335|SUPERIORITY|The Mixed-Effect Model Repeat Measurement with Baseline value, categorical fixed effects of treatment, visit and treatment-by-visit interaction, stratification factors at randomization (Baseline CS dose (prednisone or prednisolone \>30 mg, prednisone or prednisolone ≤30 mg) and Baseline disease status (new onset disease, relapsing disease)) included in the model. An unstructured variance covariance matrix is used. Data after initiation of corticosteroid escape therapy are excluded from the model.|LS Mean Difference|2.6094|STANDARD_ERROR_OF_MEAN|1.4185|=|0.067|TWO_SIDED|95.0|-0.1841|5.4028|||Mixed-Effect Model Repeat Measurement||Difference = 7.5 mg Upadacitinib - Placebo|7.5 mg Upadacitinib + 26-week CS taper vs Placebo + 52-week CS taper||5.4028|-0.1841|=0.0670
72484821|NCT02012296|144497449|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
72484822|NCT02012296|144497450|SUPERIORITY|||||||0.0002|||||||t-test, 2 sided|||||||0.0002
72484823|NCT03627767|144497459|SUPERIORITY||Hazard Ratio (HR)|0.35|||<|0.0001|TWO_SIDED|95.0|0.286|0.424||A stratified log-rank test with age group and disease severity as stratification variables was performed to evaluate P value.|Log Rank|||A Cox regression model with treatment, age group and disease severity as stratification covariates was used to estimate the hazard ratio and the corresponding 95% CI.||0.424|0.286|< 0.0001
72484824|NCT03627767|144497459|SUPERIORITY||Hazard Ratio (HR)|0.22|||<|0.0001|TWO_SIDED|95.0|0.176|0.27||A stratified log-rank test with age group and disease severity as stratification variables was performed to evaluate P value.|Log Rank|||A Cox regression model with treatment, age group and disease severity as stratification covariates was used to estimate the hazard ratio and the corresponding 95% CI.||0.270|0.176|< 0.0001
72484825|NCT03627767|144497459|SUPERIORITY||Hazard Ratio (HR)|0.63|||<|0.0001|TWO_SIDED|95.0|0.503|0.78||A stratified log-rank test with age group and disease severity as stratification variables was performed to evaluate P value.|Log Rank|||A Cox regression model with treatment, age group and disease severity as stratification covariates was used to estimate the hazard ratio and the corresponding 95% CI.||0.780|0.503|< 0.0001
72484826|NCT03627767|144497460|SUPERIORITY||Difference in percentage|0.0|||=|0.9495|TWO_SIDED|95.0|-1.0|1.1||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 12: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||1.1|-1.0|= 0.9495
72484827|NCT03627767|144497460|SUPERIORITY||Difference in percentage|-0.4|||=|0.5717|TWO_SIDED|95.0|-1.6|0.9||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 12: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||0.9|-1.6|= 0.5717
72484828|NCT03627767|144497460|SUPERIORITY||Difference in percentage|-0.4|||||TWO_SIDED|95.0|-1.7|0.9||||||Week 12: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||0.9|-1.7|
72484829|NCT03627767|144497460|SUPERIORITY||Difference in percentage|40.5|||<|0.0001|TWO_SIDED|95.0|33.1|47.8||P-value was adjusted by disease severity at baseline and randomization strata|Cochran-Mantel-Haenszel|||Week 16: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||47.8|33.1|< 0.0001
72576886|NCT00261443|144680707|SUPERIORITY_OR_OTHER_LEGACY|||||||0.423||95.0|||||Wilcoxon Rank Sum Test|||Week 52 LOCF Treatment Comparison; Aripiprazole/Placebo||||0.423
72576887|NCT00261443|144680707|SUPERIORITY_OR_OTHER_LEGACY|||||||0.297||95.0|||||Wilcoxon Rank Sum Test|||Highest Value Treatment Comparison; Aripiprazole/Placebo||||0.297
72576888|NCT00261443|144680707|SUPERIORITY_OR_OTHER_LEGACY|||||||0.707||95.0|||||Wilcoxon Rank Sum Test|||Lowest Value Treatment Comparison; Aripiprazole/Placebo||||0.707
72576889|NCT00261443|144680708|SUPERIORITY_OR_OTHER_LEGACY|||||||0.656||95.0|||||Wilcoxon Rank Sum Test|||Baseline Treatment Comparison; Aripiprazole/Placebo||||0.656
72576890|NCT00261443|144680708|SUPERIORITY_OR_OTHER_LEGACY|||||||0.045||95.0|||||Wilcoxon Rank Sum Test|||Week 52 LOCF Treatment Comparison; Aripiprazole/Placebo||||0.045
72576891|NCT00261443|144680708|SUPERIORITY_OR_OTHER_LEGACY|||||||0.532||95.0|||||Wilcoxon Rank Sum Test|||Highest Value Treatment Comparison; Aripiprazole/Placebo||||0.532
72576892|NCT00261443|144680708|SUPERIORITY_OR_OTHER_LEGACY|||||||0.578||95.0|||||Wilcoxon Rank Sum Test|||Lowest Value Treatment Comparison; Aripiprazole/Placebo||||0.578
72576893|NCT00261443|144680709|SUPERIORITY_OR_OTHER_LEGACY|||||||0.619||95.0|||||Wilcoxon Rank Sum Test|||Baseline Treatment Comparison; Aripiprazole/Placebo||||0.619
72402489|NCT01480076|144311682|SUPERIORITY_OR_OTHER|||||||0.0027|||||||mixed effect model|||Overall, PPMS. Mixed effect model for repeated measures with visit, baseline of the current health state of EQ-5D scores, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0027
72402490|NCT01480076|144311682|SUPERIORITY_OR_OTHER|||||||0.0167|||||||mixed effect model|||Overall, PRMS. Mixed effect model for repeated measures with visit, baseline of the current health state of EQ-5D scores, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0167
72402491|NCT01480076|144311682|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 3, RRMS. Mixed effect model for repeated measures with visit, baseline of the current health state of EQ-5D scores, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
72402492|NCT01480076|144311682|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 3, SPMS. Mixed effect model for repeated measures with visit, baseline of the current health state of EQ-5D scores, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
72402493|NCT01480076|144311682|SUPERIORITY_OR_OTHER|||||||0.0024|||||||mixed effect model|||Month 3, PPMS. Mixed effect model for repeated measures with visit, baseline of the current health state of EQ-5D scores, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0024
72402494|NCT01480076|144311682|SUPERIORITY_OR_OTHER|||||||0.0669|||||||mixed effect model|||Month 3, PRMS. Mixed effect model for repeated measures with visit, baseline of the current health state of EQ-5D scores, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0669
72484830|NCT03627767|144497460|SUPERIORITY||Difference in percentage|62.6|||<|0.0001|TWO_SIDED|95.0|56.1|69.2||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 16: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||69.2|56.1|< 0.0001
72484831|NCT03627767|144497460|SUPERIORITY||Difference in percentage|22.1|||||TWO_SIDED|95.0|14.3|29.9||||||Week 16: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||29.9|14.3|
72484832|NCT03627767|144497460|SUPERIORITY||Difference in percentage|35.1|||<|0.0001|TWO_SIDED|95.0|28.1|42.0||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 28: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||42.0|28.1|< 0.0001
72512209|NCT03725202|144554336|SUPERIORITY|Comparisons between each upadacitinib treatment group and the placebo group are carried out using Poisson regression model with stratification factors as covariates and log(duration of study participation in years) as an offset. Robust standard error is used in inference.|Rate Ratio|0.6||||0.001|TWO_SIDED|95.0|0.4|0.8|||Poisson regression model|||15 mg Upadacitinib + 26-week CS taper vs Placebo + 52-week CS taper||0.8|0.4|0.0010
72567469|NCT03247517|144666040|SUPERIORITY||Least Square Mean Difference|-5.1|STANDARD_ERROR_OF_MEAN|1.93||0.0091|TWO_SIDED|95.0|-8.9|-1.3|||Mixed Models for Repeated Measures|||||-1.3|-8.9|0.0091
72567470|NCT03247517|144666041|SUPERIORITY||Least Square Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.17||0.0042|TWO_SIDED|95.0|-0.8|-0.2|||ANCOVA|ANCOVA model with baseline Clinical Global Impression-Severity of Illness (CGI-S) score and treatment as fixed independent variables.||||-0.2|-0.8|0.0042
72402495|NCT01480076|144311682|SUPERIORITY_OR_OTHER|||||||0.0018|||||||mixed effect model|||Month 6, RRMS. Mixed effect model for repeated measures with visit, baseline of the current health state of EQ-5D scores, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0018
72402496|NCT01480076|144311682|SUPERIORITY_OR_OTHER|||||||0.0004|||||||mixed effect model|||Month 6, SPMS. Mixed effect model for repeated measures with visit, baseline of the current health state of EQ-5D scores, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0004
72512210|NCT03725202|144554336|SUPERIORITY|Comparisons between each upadacitinib treatment group and the placebo group are carried out using Poisson regression model with stratification factors as covariates and log(duration of study participation in years) as an offset. Robust standard error is used in inference.|Rate Ratio|0.8|||=|0.2722|TWO_SIDED|95.0|0.6|1.2|||Poisson regression model|||7.5 mg Upadacitinib + 26-week CS taper vs Placebo + 52-week CS taper||1.2|0.6|=0.2722
72567471|NCT03247517|144666041|SUPERIORITY||Least Square Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.16||0.0003|TWO_SIDED|95.0|-0.9|-0.3|||ANCOVA|ANCOVA model with baseline Clinical Global Impression-Severity of Illness (CGI-S) score and treatment as fixed independent variables.||||-0.3|-0.9|0.0003
72567472|NCT03247517|144666042|SUPERIORITY||Least Square Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|1.54||0.6854|TWO_SIDED|95.0|-3.6|2.4|||ANCOVA|||||2.4|-3.6|0.6854
72567473|NCT03247517|144666042|SUPERIORITY||Least Square Mean Difference|-2.9|STANDARD_ERROR_OF_MEAN|1.49||0.0518|TWO_SIDED|95.0|-5.8|0.0|||ANCOVA|||||0.0|-5.8|0.0518
72567474|NCT03247517|144666043|SUPERIORITY||Least Square Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.061||0.2062|TWO_SIDED|95.0|-0.2|0.04|||ANCOVA|||||0.04|-0.20|0.2062
72567475|NCT03247517|144666043|SUPERIORITY||Least Square Mean Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.059||0.0519|TWO_SIDED|95.0|-0.23|0.0|||ANCOVA|||||0.00|-0.23|0.0519
72484833|NCT03627767|144497460|SUPERIORITY||Difference in percentage|51.5|||<|0.0001|TWO_SIDED|95.0|44.6|58.4||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 28: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||58.4|44.6|< 0.0001
72484834|NCT03627767|144497460|SUPERIORITY||Difference in percentage|16.5|||||TWO_SIDED|95.0|8.1|24.8||||||Week 28: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||24.8|8.1|
72484835|NCT03627767|144497460|SUPERIORITY||Difference in percentage|32.2|||<|0.0001|TWO_SIDED|95.0|25.2|39.2||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 40: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||39.2|25.2|< 0.0001
72484836|NCT03627767|144497460|SUPERIORITY||Difference in percentage|46.9|||<|0.0001|TWO_SIDED|95.0|39.9|53.8||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 40: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||53.8|39.9|< 0.0001
72484837|NCT03627767|144497460|SUPERIORITY||Difference in percentage|14.2|||||TWO_SIDED|95.0|5.9|22.6||||||Week 40: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||22.6|5.9|
72484838|NCT03627767|144497460|SUPERIORITY||Difference in percentage|25.5|||<|0.0001|TWO_SIDED|95.0|18.5|32.5||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 52: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||32.5|18.5|< 0.0001
72484839|NCT03627767|144497460|SUPERIORITY||Difference in percentage|42.5|||<|0.0001|TWO_SIDED|95.0|35.3|49.7||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 52: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||49.7|35.3|< 0.0001
72484840|NCT03627767|144497460|SUPERIORITY||Difference in percentage|17.1|||||TWO_SIDED|95.0|8.6|25.5||||||Week 52: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||25.5|8.6|
72484841|NCT03627767|144497461|SUPERIORITY||Difference in percentage|0.0|||||TWO_SIDED|95.0|0.0|0.0||||||Week 12: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||0.0|0.0|
72484842|NCT03627767|144497461|SUPERIORITY||Difference in percentage|0.0|||||TWO_SIDED|95.0|0.0|0.0||||||Week 12: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions. P-value was adjusted by disease severity at baseline and randomization strata.||0.0|0.0|
72512211|NCT03725202|144554337|SUPERIORITY|The Mixed-Effect Model Repeat Measurement with Baseline value, categorical fixed effects of treatment, visit and treatment-by-visit interaction, stratification factors at randomization (Baseline CS dose (prednisone or prednisolone \>30 mg, prednisone or prednisolone ≤30 mg) and Baseline disease status (new onset disease, relapsing disease)) included in the model. An unstructured variance covariance matrix is used. Data after initiation of corticosteroid escape therapy are excluded from the model.|LS Mean Difference|4.0|STANDARD_ERROR_OF_MEAN|1.38|=|0.0036|TWO_SIDED|95.0|1.33|6.76|||Mixed-Effect Model Repeat Measurement||Difference = 15 mg Upadacitinib -Placebo|15 mg Upadacitinib + 26-week CS taper vs Placebo + 52-week CS taper||6.76|1.33|=0.0036
72567476|NCT03247517|144666044|SUPERIORITY||Risk Difference (RD)|18.8||||0.0068|TWO_SIDED|95.0|5.5|32.2|||Regression, Logistic|||||32.2|5.5|0.0068
72484843|NCT03627767|144497461|SUPERIORITY||Difference in percentage|0.0|||||TWO_SIDED|95.0|0.0|0.0||||||Week 12: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||0.0|0.0|
72484844|NCT03627767|144497461|SUPERIORITY||Difference in percentage|42.7|||<|0.0001|TWO_SIDED|95.0|35.3|50.1||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 16: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||50.1|35.3|< 0.0001
72567477|NCT03247517|144666044|SUPERIORITY||Risk Difference (RD)|17.6||||0.0095|TWO_SIDED|95.0|4.6|30.5|||Regression, Logistic|||||30.5|4.6|0.0095
72567478|NCT03247517|144666045|SUPERIORITY||Least Square Mean Difference|1.7|STANDARD_ERROR_OF_MEAN|5.51||0.7629|TWO_SIDED|95.0|-9.1|12.5|||ANCOVA|||||12.5|-9.1|0.7629
72484845|NCT03627767|144497461|SUPERIORITY||Difference in percentage|55.4|||<|0.0001|TWO_SIDED|95.0|49.1|61.7||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 16: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||61.7|49.1|< 0.0001
72484846|NCT03627767|144497461|SUPERIORITY||Difference in percentage|12.9|||||TWO_SIDED|95.0|7.9|17.9||||||Week 16: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||17.9|7.9|
72484847|NCT03627767|144497461|SUPERIORITY||Difference in percentage|45.5|||<|0.0001|TWO_SIDED|95.0|37.9|53.0||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 28: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||53.0|37.9|< 0.0001
72484848|NCT03627767|144497461|SUPERIORITY||Difference in percentage|63.0|||<|0.0001|TWO_SIDED|95.0|56.4|69.5||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 28: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||69.5|56.4|< 0.0001
72484849|NCT03627767|144497461|SUPERIORITY||Difference in percentage|17.7|||||TWO_SIDED|95.0|10.7|24.7||||||Week 28: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions||24.7|10.7|
72484850|NCT03627767|144497461|SUPERIORITY||Difference in percentage|41.0|||<|0.0001|TWO_SIDED|95.0|33.6|48.5||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 40: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||48.5|33.6|< 0.0001
72484851|NCT03627767|144497461|SUPERIORITY||Difference in percentage|58.3|||<|0.0001|TWO_SIDED|95.0|51.3|65.2||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 40: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||65.2|51.3|< 0.0001
72484852|NCT03627767|144497461|SUPERIORITY||Difference in percentage|17.5|||||TWO_SIDED|95.0|9.6|25.5||||||Week 40: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||25.5|9.6|
72484853|NCT03627767|144497461|SUPERIORITY||Difference in percentage|35.3|||<|0.0001|TWO_SIDED|95.0|27.8|42.8||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 52: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||42.8|27.8|< 0.0001
72567479|NCT03247517|144666045|SUPERIORITY||Least Square Mean Difference|-1.6|STANDARD_ERROR_OF_MEAN|5.36||0.7648|TWO_SIDED|95.0|-12.1|8.9|||ANCOVA|||||8.9|-12.1|0.7648
72567480|NCT03247517|144666046|SUPERIORITY||Least Square Mean Difference|-2.7|STANDARD_ERROR_OF_MEAN|0.99||0.0069|TWO_SIDED|95.0|-4.6|-0.7|||ANCOVA|||This analysis pertains to the Hyperactivity/Impulsivity subscale score||-0.7|-4.6|0.0069
72567481|NCT03247517|144666046|SUPERIORITY||Least Square Mean Difference|-3.4|STANDARD_ERROR_OF_MEAN|0.96||0.0005|TWO_SIDED|95.0|-5.2|-1.5|||ANCOVA|||This analysis pertains to the Hyperactivity/Impulsivity subscale score||-1.5|-5.2|0.0005
72567482|NCT03247517|144666046|SUPERIORITY||Least Square Mean Difference|-2.1|STANDARD_ERROR_OF_MEAN|1.05||0.0424|TWO_SIDED|95.0|-4.2|-0.1|||ANCOVA|||This analysis pertains to the Inattention subscale score||-0.1|-4.2|0.0424
72567483|NCT03247517|144666046|SUPERIORITY||Least Square Mean Difference|-2.1|STANDARD_ERROR_OF_MEAN|1.03||0.039|TWO_SIDED|95.0|-4.1|-0.1|||ANCOVA|||This analysis pertains to the Inattention subscale score||-0.1|-4.1|0.0390
72567484|NCT03247517|144666047|SUPERIORITY||Least Square Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|1.2||0.3813|TWO_SIDED|95.0|-3.4|1.3|||ANCOVA|||||1.3|-3.4|0.3813
72567485|NCT03247517|144666047|SUPERIORITY||Least Square Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|1.17||0.9506|TWO_SIDED|95.0|-2.4|2.2|||ANCOVA|||||2.2|-2.4|0.9506
72567486|NCT03247517|144666048|SUPERIORITY|||||||0.0254|||||||Chi-squared|||This analysis pertains to Week 1||||0.0254
72567487|NCT03247517|144666048|SUPERIORITY|||||||0.0899|||||||Chi-squared|||This analysis pertains to Week 2||||0.0899
72567488|NCT03247517|144666048|SUPERIORITY|||||||0.007|||||||Chi-squared|||This analysis pertains to Week 3||||0.0070
72567489|NCT03247517|144666048|SUPERIORITY|||||||0.0031|||||||Chi-squared|||This analysis pertains to Week 4||||0.0031
72567490|NCT03247517|144666048|SUPERIORITY|||||||0.0065|||||||Chi-squared|||This analysis pertains to Week 5||||0.0065
72567491|NCT03247517|144666048|SUPERIORITY|||||||0.007|||||||Chi-squared|||This analysis pertains to Week 6||||0.0070
72567492|NCT03247517|144666048|SUPERIORITY|||||||0.0063|||||||Chi-squared|||This analysis pertains to Week 1||||0.0063
72567493|NCT03247517|144666048|SUPERIORITY|||||||0.0123|||||||Chi-squared|||This analysis pertains to Week 2||||0.0123
72567494|NCT03247517|144666048|SUPERIORITY|||||||0.0003|||||||Chi-squared|||This analysis pertains to Week 3||||0.0003
72484854|NCT03627767|144497461|OTHER||Difference in percentage|55.3|||<|0.0001|TWO_SIDED|95.0|48.3|62.4||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 52: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||62.4|48.3|< 0.0001
72484855|NCT03627767|144497461|SUPERIORITY||Difference in percentage|20.3|||||TWO_SIDED|95.0|12.1|28.5||||||Week 52: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||28.5|12.1|
72484856|NCT03627767|144497462|SUPERIORITY||Difference in percentage|0.7|||=|0.1848|TWO_SIDED|95.0|-0.3|1.7||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 12: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||1.7|-0.3|= 0.1848
72484857|NCT03627767|144497462|SUPERIORITY||Difference in percentage|0.3|||=|0.5971|TWO_SIDED|95.0|-0.9|1.6||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 12: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||1.6|-0.9|= 0.5971
72484858|NCT03627767|144497462|SUPERIORITY||Difference in percentage|-0.4|||||TWO_SIDED|95.0|-1.1|0.4||||||Week 12: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||0.4|-1.1|
72512212|NCT03725202|144554337|SUPERIORITY|The Mixed-Effect Model Repeat Measurement with Baseline value, categorical fixed effects of treatment, visit and treatment-by-visit interaction, stratification factors at randomization (Baseline CS dose (prednisone or prednisolone \>30 mg, prednisone or prednisolone ≤30 mg) and Baseline disease status (new onset disease, relapsing disease)) included in the model. An unstructured variance covariance matrix is used. Data after initiation of corticosteroid escape therapy are excluded from the model.|LS Mean Difference|3.5|STANDARD_ERROR_OF_MEAN|1.63|=|0.0338|TWO_SIDED|95.0|0.27|6.7|||Mixed-Effect Model Repeat Measurement||Difference = 7.5 mg Upadacitinib -Placebo|7.5 mg Upadacitinib + 26-week CS taper vs Placebo + 52-week CS taper||6.70|0.27|=0.0338
72512213|NCT03725202|144554338|SUPERIORITY|The Mixed-Effect Model Repeat Measurement with Baseline value, categorical fixed effects of treatment, visit and treatment-by-visit interaction, stratification factors at randomization (Baseline CS dose (prednisone or prednisolone \>30 mg, prednisone or prednisolone ≤30 mg) and Baseline disease status (new onset disease, relapsing disease)) included in the model. An unstructured variance covariance matrix is used. Data after initiation of corticosteroid escape therapy are excluded from the model.|LS Mean Difference|2.7325|STANDARD_ERROR_OF_MEAN|2.9635|=|0.3573|TWO_SIDED|95.0|-3.102|8.567|||Mixed-Effect Model Repeat Measurement||Difference = 15 mg Upadacitinib -Placebo|15 mg Upadacitinib + 26-week CS taper vs Placebo + 52-week CS taper||8.5670|-3.1020|=0.3573
72512214|NCT03725202|144554338|SUPERIORITY|The Mixed-Effect Model Repeat Measurement with Baseline value, categorical fixed effects of treatment, visit and treatment-by-visit interaction, stratification factors at randomization (Baseline CS dose (prednisone or prednisolone \>30 mg, prednisone or prednisolone ≤30 mg) and Baseline disease status (new onset disease, relapsing disease)) included in the model. An unstructured variance covariance matrix is used. Data after initiation of corticosteroid escape therapy are excluded from the model.|LS Mean Difference|5.4216|STANDARD_ERROR_OF_MEAN|3.4785|=|0.1203|TWO_SIDED|95.0|-1.4269|12.2701|||Mixed-Effect Model Repeat Measurement||Difference = 7.5 mg Upadacitinib -Placebo|7.5 mg Upadacitinib + 26-week CS taper vs Placebo + 52-week CS taper||12.2701|-1.4269|=0.1203
72512215|NCT03725202|144554339|SUPERIORITY|Comparisons between each upadacitinib treatment group and the placebo group are carried out using Poisson regression model with stratification factors as covariates and log(duration of study participation in years) as an offset. Robust standard error is used in inference.|Rate Ratio|1.1|||=|0.4371|TWO_SIDED|95.0|0.8|1.6|||Poisson regression model|||15 mg Upadacitinib + 26-week CS taper vs Placebo + 52-week CS taper||1.6|0.8|=0.4371
72512216|NCT03725202|144554339|SUPERIORITY|Comparisons between each upadacitinib treatment group and the placebo group are carried out using Poisson regression model with stratification factors as covariates and log(duration of study participation in years) as an offset. Robust standard error is used in inference.|Rate Ratio|0.9|||=|0.7749|TWO_SIDED|95.0|0.6|1.4|||Poisson regression model|||7.5 mg Upadacitinib + 26-week CS taper vs Placebo + 52-week CS taper||1.4|0.6|=0.7749
72567495|NCT03247517|144666048|SUPERIORITY|||||||0.0001|||||||Chi-squared|||This analysis pertains to Week 4||||0.0001
72484859|NCT03627767|144497462|SUPERIORITY||Difference in percentage|49.4|||<|0.0001|TWO_SIDED|95.0|42.0|56.8||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 16: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||56.8|42.0|< 0.0001
72512217|NCT01328249|144554343|OTHER|Fisher's Exact test||||||0.4422||||||Null hypothesis: The feasibility rates of Cohort 1 and Cohort 2 are same.|Fisher Exact|Exploratory analysis comparing primary feasibilities between 2 cohorts, based on Fisher's Exact test.||||||0.4422
72512218|NCT01716533|144554347|SUPERIORITY||GMC ratio|1.53||||0.5746|TWO_SIDED|95.0|0.33|7.14||P-value = two-sided p-value for HO: GMC ratio = 1 (ANOVA model, T-test), groups considered as statistically significant different if the two-sided p-value is below 0.05.|ANOVA|ANOVA model -pooled variance.|GMC ratio = GMC Sustained response Group /GMC Recurrence Group.|ELISA anti-toxin B antibody concentrations at Day 14 were compared between the Sustained response Group and Recurrence Group by using a one-way analysis of variance (ANOVA) model on the log-transformed concentration.||7.14|0.33|0.5746
72567496|NCT03247517|144666048|SUPERIORITY|||||||0.0025|||||||Chi-squared|||This analysis pertains to Week 5||||0.0025
72567497|NCT03247517|144666048|SUPERIORITY|||||||0.0033|||||||Chi-squared|||This analysis pertains to Week 6||||0.0033
72624086|NCT05293314|144778520|OTHER|Sensitivity=number of true positives/(number of true positives+number of false negatives) \* 100% Sensitivity is the rate of correctly judging patients.We calculated the sensitivity of the breath test model to distinguish bronchiectasis from healthy people.The maximum percentage of the sensitivity is 100%. The higher the percentage is , the more sensitive of the model.|Sensitivity|86.2|||||TWO_SIDED|95.0|77.1|95.2||||||Sensitivity=number of true positives/(number of true positives+number of false negatives) \* 100% Sensitivity is the rate of correctly judging patients.We calculated the sensitivity of the breath test model to distinguish bronchiectasis from healthy people.The maximum percentage of the sensitivity is 100%. The higher the percentage is , the more sensitive of the model.||95.2|77.1|
72624087|NCT05293314|144778521|OTHER|Specificity=number of true negative cases/(number of true negative cases+number of false positive cases) \* 100% The specificity is the rate of correctly judging non patients.We calculated the specificity of the breath test model to distinguish bronchiectasis from healthy people.The maximum percentage of the specificity is 100%. The higher the percentage is , the more specificity of the model.|Specificity|92.5|||||TWO_SIDED|95.0|86.2|98.8||||||Specificity=number of true negative cases/(number of true negative cases+number of false positive cases) \* 100% The specificity is the rate of correctly judging non patients.We calculated the specificity of the breath test model to distinguish bronchiectasis from healthy people.The maximum percentage of the specificity is 100%. The higher the percentage is , the more specificity of the model.||98.8|86.2|
72484860|NCT03627767|144497462|SUPERIORITY||Difference in percentage|65.5|||<|0.0001|TWO_SIDED|95.0|59.3|71.7||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 16: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||71.7|59.3|< 0.0001
72484861|NCT03627767|144497462|SUPERIORITY||Difference in percentage|16.3|||||TWO_SIDED|95.0|10.3|22.3||||||Week 16: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||22.3|10.3|
72484862|NCT03627767|144497462|SUPERIORITY||Difference in percentage|42.7|||<|0.0001|TWO_SIDED|95.0|35.2|50.2||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 28: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||50.2|35.2|< 0.0001
72484863|NCT03627767|144497462|SUPERIORITY||Difference in percentage|62.6|||<|0.0001|TWO_SIDED|95.0|56.0|69.2||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 28: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||69.2|56.0|< 0.0001
72484864|NCT03627767|144497462|SUPERIORITY||Difference in percentage|19.8|||||TWO_SIDED|95.0|12.3|27.4||||||Week 28: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||27.4|12.3|
72484865|NCT03627767|144497462|SUPERIORITY||Difference in percentage|39.5|||<|0.0001|TWO_SIDED|95.0|32.1|46.9||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 40: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||46.9|32.1|< 0.0001
72484866|NCT03627767|144497462|SUPERIORITY||Difference in percentage|56.7|||<|0.0001|TWO_SIDED|95.0|49.8|63.7||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 40: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||63.7|49.8|< 0.0001
72484867|NCT03627767|144497462|SUPERIORITY||Difference in percentage|17.4|||||TWO_SIDED|95.0|9.3|25.5||||||Week 40: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||25.5|9.3|
72484868|NCT03627767|144497462|SUPERIORITY||Difference in percentage|33.0|||<|0.0001|TWO_SIDED|95.0|25.7|40.4||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 52: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||40.4|25.7|< 0.0001
72512219|NCT01716533|144554348|SUPERIORITY|ANOVA model -pooled variance.|GMC ratio|1.65||||0.7124|TWO_SIDED|95.0|0.1|26.41||P-value = two-sided p-value for HO: GMC ratio = 1, groups considered as statistically significant different if the two-sided p-value is below 0.05.|ANOVA||GMC ratio = GMC Sustained response Group /GMC Recurrence Group.|Serum F2 C-terminal anti-toxin B antibody concentrations at Day 14 were compared between the Sustained response Group and Recurrence Group by using a one-way analysis of variance (ANOVA) model on the log-transformed concentration.||26.41|0.10|0.7124
72512220|NCT02330549|144554359|OTHER|This was a proof of concept study, and is not powered for statistical detection of differences between groups, no adjustments for multiplicity was made, or no-imputation for missing data.|LS Mean Difference|-0.2286|STANDARD_ERROR_OF_MEAN|0.195||0.2483|TWO_SIDED|95.0|-0.62|0.17||An analysis of covariance (ANCOVA) model that included treatment and presence or absence of nonalcoholic steatohepatitis (NASH) as factors, and the baseline value of Matsuda index as a covariate was used for analysis.|ANCOVA|||Change from Baseline to Week 12||0.17|-0.62|0.2483
72512221|NCT02330549|144554359|OTHER|This was a proof of concept study, and is not powered for statistical detection of differences between groups, no adjustments for multiplicity was made, or no-imputation for missing data.|LS Mean Difference|-0.4113|STANDARD_ERROR_OF_MEAN|0.205||0.053|TWO_SIDED|95.0|-0.83|0.01||An ANCOVA model that included treatment and presence or absence of NASH as factors, and the baseline value of Matsuda index as a covariate was used for analysis.|ANCOVA|||Change form Baseline to Week 24||0.01|-0.83|0.053
72512222|NCT02330549|144554360|OTHER|This was a proof of concept study, and is not powered for statistical detection of differences between groups, no adjustments for multiplicity was made, or no-imputation for missing data.|LS Mean Difference|-1.505|STANDARD_ERROR_OF_MEAN|2.369||0.5297|TWO_SIDED|95.0|-6.33|3.32||An ANCOVA model that included treatment and presence or absence of NASH as factors, and the baseline value of ADIPO-IR as a covariate was used for analysis.|ANCOVA|||Change from Baseline to Week 12||3.32|-6.33|0.5297
72567498|NCT01429051|144666095|SUPERIORITY_OR_OTHER||LS Mean Difference|1.1||||0.002|TWO_SIDED|95.0|0.41|1.179|||Mixed Models Analysis|A mixed effects model with episode baseline PI as a covariate, treatment as a fixed effect and patient as a random effect.||||1.179|0.41|0.002
72512223|NCT02330549|144554360|OTHER|This was a proof of concept study, and is not powered for statistical detection of differences between groups, no adjustments for multiplicity was made, or no-imputation for missing data.|LS Mean Difference|3.2146|STANDARD_ERROR_OF_MEAN|2.757||0.2522|TWO_SIDED|95.0|-2.4|8.83||An ANCOVA model that included treatment and presence or absence of NASH as factors, and the baseline value of ADIPO-IR as a covariate was used for analysis.|ANCOVA|||Change from Baseline to Week 24||8.83|-2.4|0.2522
72512224|NCT00495495|144554431|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.02||||0.1126|ONE_SIDED||||||McNemar|||"Null hypothesis: there is no difference between the HealOzone and Placebo devices in the proportion of teeth with lesion progression after 1 year.~Power calculation: the study was sized to have 90% power to detect a 15% difference between treatments in the percentage of teeth with lesion progression at one year (i.e., assuming 45% for the lesions treated with the Placebo device and 30% for the lesions treated with the HealOzone device) with a sample size of 258 subjects completing the study."||||0.1126
72512225|NCT00495495|144554432|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.08||||0.9777|ONE_SIDED||||||McNemar|||||||.9777
72512226|NCT00495495|144554433|SUPERIORITY_OR_OTHER|||||||0.0416|ONE_SIDED|95.0|||||McNemar|||||||.0416
72402497|NCT01480076|144311682|SUPERIORITY_OR_OTHER|||||||0.019|||||||mixed effect model|||Month 6, PPMS. Mixed effect model for repeated measures with visit, baseline of the current health state of EQ-5D scores, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0190
72402498|NCT01480076|144311682|SUPERIORITY_OR_OTHER|||||||0.0106|||||||mixed effect model|||Month 6, PRMS. Mixed effect model for repeated measures with visit, baseline of the current health state of EQ-5D scores, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0106
72567499|NCT03728634|144666141|SUPERIORITY||||||<|0.001|||||||Analysis of Variance(ANOVA)|||Change From Baseline in Plasma TTR Levels Following Multiple-Dose Administration of ION-TTR-LRx at Day 29: 45 mg||||<0.001
72402499|NCT01480076|144311682|SUPERIORITY_OR_OTHER|||||||0.0009|||||||mixed effect model|||Month 9, RRMS. Mixed effect model for repeated measures with visit, baseline of the current health state of EQ-5D scores, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0009
72402500|NCT01480076|144311682|SUPERIORITY_OR_OTHER|||||||0.1937|||||||mixed effect model|||Month 9, SPMS. Mixed effect model for repeated measures with visit, baseline of the current health state of EQ-5D scores, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||0.1937
72402501|NCT01480076|144311682|SUPERIORITY_OR_OTHER|||||||0.0445|||||||mixed effect model|||Month 9, PPMS. Mixed effect model for repeated measures with visit, baseline of the current health state of EQ-5D scores, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0445
72402502|NCT01480076|144311682|SUPERIORITY_OR_OTHER|||||||0.6475|||||||mixed effect model|||Month 9, PRMS. Mixed effect model for repeated measures with visit, baseline of the current health state of EQ-5D scores, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||0.6475
72402503|NCT01480076|144311682|SUPERIORITY_OR_OTHER|||||||0.0097|||||||mixed effect model|||Month 12, RRMS. Mixed effect model for repeated measures with visit, baseline of the current health state of EQ-5D scores, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0097
72402504|NCT01480076|144311682|SUPERIORITY_OR_OTHER|||||||0.0386|||||||mixed effect model|||Month 12, SPMS. Mixed effect model for repeated measures with visit, baseline of the current health state of EQ-5D scores, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0386
72402505|NCT01480076|144311682|SUPERIORITY_OR_OTHER|||||||0.0219|||||||mixed effect model|||Month 12, PPMS. Mixed effect model for repeated measures with visit, baseline of the current health state of EQ-5D scores, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0219
72402506|NCT01480076|144311682|SUPERIORITY_OR_OTHER|||||||0.0076|||||||mixed effect model|||Month 12, PRMS. Mixed effect model for repeated measures with visit, baseline of the current health state of EQ-5D scores, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0076
72484869|NCT03627767|144497462|SUPERIORITY||Difference in percentage|51.7|||<|0.0001|TWO_SIDED|95.0|44.6|58.8||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 52: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||58.8|44.6|< 0.0001
72484870|NCT03627767|144497462|SUPERIORITY||Difference in percentage|19.2|||||TWO_SIDED|95.0|10.8|27.6||||||Week 52: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||27.6|10.8|
72402507|NCT01480076|144311683|SUPERIORITY_OR_OTHER|||||||0.1471|||||||mixed effect model|||Overall, RRMS. Mixed effect model for repeated measures with visit, baseline of percentage of work time missed due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.1471
72402508|NCT01480076|144311683|SUPERIORITY_OR_OTHER|||||||0.5503|||||||mixed effect model|||Overall, SPMS. Mixed effect model for repeated measures with visit, baseline of percentage of work time missed due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.5503
72567500|NCT03728634|144666141|SUPERIORITY||||||<|0.001|||||||ANOVA|||Change From Baseline in Plasma TTR Levels Following Multiple-Dose Administration of ION-TTR-LRx at Day 29: 60 mg||||<0.001
72567501|NCT03728634|144666141|SUPERIORITY||||||<|0.001|||||||ANOVA|||Change From Baseline in Plasma TTR Levels Following Multiple-Dose Administration of ION-TTR-LRx at Day 29: 90 mg||||<0.001
72567502|NCT03728634|144666141|SUPERIORITY||||||<|0.001|||||||ANOVA|||Change From Baseline in Plasma TTR Levels Following Multiple-Dose Administration of ION-TTR-LRx at Day 99: 45 mg||||<0.001
72402509|NCT01480076|144311683|SUPERIORITY_OR_OTHER|||||||0.3854|||||||mixed effect model|||Overall, PPMS. Mixed effect model for repeated measures with visit, baseline of percentage of work time missed due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.3854
72484871|NCT03627767|144497463|SUPERIORITY||Difference in percentage|2.6|||=|0.3994|TWO_SIDED|95.0|-3.3|8.4||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 12: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||8.4|-3.3|= 0.3994
72484872|NCT03627767|144497463|SUPERIORITY||Difference in percentage|1.8|||=|0.5542|TWO_SIDED|95.0|-4.1|7.8||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 12: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||7.8|-4.1|= 0.5542
72484873|NCT03627767|144497463|SUPERIORITY||Difference in percentage|-0.8|||||TWO_SIDED|95.0|-6.5|5.0||||||Week 12: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||5.0|-6.5|
72484874|NCT03627767|144497463|SUPERIORITY||Difference in percentage|37.5|||<|0.0001|TWO_SIDED|95.0|30.2|44.9||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 16: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||44.9|30.2|< 0.0001
72484875|NCT03627767|144497463|SUPERIORITY||Difference in percentage|63.3|||<|0.0001|TWO_SIDED|95.0|56.8|69.8||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 16: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||69.8|56.8|< 0.0001
72484876|NCT03627767|144497463|SUPERIORITY||Difference in percentage|25.5|||||TWO_SIDED|95.0|17.7|33.4||||||Week 16: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||33.4|17.7|
72484877|NCT03627767|144497463|SUPERIORITY||Difference in percentage|36.9|||<|0.0001|TWO_SIDED|95.0|29.9|44.0||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 28: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||44.0|29.9|< 0.0001
72484878|NCT03627767|144497463|SUPERIORITY||Difference in percentage|54.2|||<|0.0001|TWO_SIDED|95.0|47.3|61.0||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 28: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||61.0|47.3|< 0.0001
72512227|NCT00495495|144554434|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.01||||0.6585|ONE_SIDED|95.0|||||McNemar|||||||0.6585
72512228|NCT00495495|144554435|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.02||||0.7666|ONE_SIDED|95.0|||||McNemar|||||||.7666
72484879|NCT03627767|144497463|SUPERIORITY||Difference in percentage|17.2|||||TWO_SIDED|95.0|8.9|25.5||||||Week 28: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||25.5|8.9|
72484880|NCT03627767|144497463|SUPERIORITY||Difference in percentage|29.8|||<|0.0001|TWO_SIDED|95.0|22.7|37.0||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 40: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||37.0|22.7|< 0.0001
72484881|NCT03627767|144497463|SUPERIORITY||Difference in percentage|46.7|||<|0.0001|TWO_SIDED|95.0|39.6|53.8||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 40: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||53.8|39.6|< 0.0001
72484882|NCT03627767|144497463|SUPERIORITY||Difference in percentage|16.9|||||TWO_SIDED|95.0|8.5|25.3||||||Week 40: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||25.3|8.5|
72512229|NCT01830543|144554470|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.59|||<|0.001|TWO_SIDED|95.0|0.47|0.76|||Log Rank|||||0.76|0.47|<0.001
72512230|NCT01830543|144554470|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.63|||<|0.001|TWO_SIDED|95.0|0.5|0.8|||Log Rank|||||0.8|0.5|<0.001
72512231|NCT01830543|144554471|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.66||||0.234|TWO_SIDED|95.0|0.33|1.31|||Log Rank|||||1.31|0.33|0.234
72512232|NCT01830543|144554471|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.57||||0.114|TWO_SIDED|95.0|0.28|1.16|||Log Rank|||||1.16|0.28|0.114
72512233|NCT01830543|144554472|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.51||||0.144|TWO_SIDED|95.0|0.2|1.28|||Log Rank|||||1.28|0.2|0.144
72512234|NCT01830543|144554472|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.5||||0.134|TWO_SIDED|95.0|0.2|1.26|||Log Rank|||||1.26|0.2|0.134
72512235|NCT01830543|144554473|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.61|||<|0.001|TWO_SIDED|95.0|0.47|0.8|||Log Rank|||||0.8|0.47|<0.001
72512236|NCT01830543|144554473|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.67||||0.002|TWO_SIDED|95.0|0.52|0.86|||Log Rank|||||0.86|0.52|0.002
72512237|NCT01830543|144554474|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.08||||0.75|TWO_SIDED|95.0|0.69|1.68|||Log Rank|||||1.68|0.69|0.75
72512238|NCT01830543|144554474|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.93||||0.765|TWO_SIDED|95.0|0.59|1.48|||Log Rank|||||1.48|0.59|0.765
72512239|NCT01830543|144554475|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.29||||0.523|TWO_SIDED|95.0|0.59|2.8|||Log Rank|||||2.8|0.59|0.523
72512240|NCT01830543|144554475|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.19||||0.664|TWO_SIDED|95.0|0.54|2.62|||Log Rank|||||2.62|0.54|0.664
72484883|NCT03627767|144497463|SUPERIORITY||Difference in percentage|27.4|||<|0.0001|TWO_SIDED|95.0|20.4|34.3||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 52: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||34.3|20.4|< 0.0001
72484884|NCT03627767|144497463|SUPERIORITY||Difference in percentage|43.8|||<|0.0001|TWO_SIDED|95.0|36.7|50.9||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 52: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||50.9|36.7|< 0.0001
72484885|NCT03627767|144497463|SUPERIORITY||Difference in percentage|16.8|||||TWO_SIDED|95.0|8.4|25.2||||||Week 52: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||25.2|8.4|
72484886|NCT03627767|144497464|SUPERIORITY||Difference in percentage|0.3|||=|0.9313|TWO_SIDED|95.0|-7.5|8.1||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 12: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||8.1|-7.5|= 0.9313
72484887|NCT03627767|144497464|SUPERIORITY||Difference in percentage|-2.1|||=|0.6043|TWO_SIDED|95.0|-9.8|5.7||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 12: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||5.7|-9.8|= 0.6043
72484888|NCT03627767|144497464|SUPERIORITY||Difference in percentage|-2.3|||||TWO_SIDED|95.0|-10.0|5.4||||||Week 12: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||5.4|-10.0|
72484889|NCT03627767|144497464|SUPERIORITY||Difference in percentage|11.6|||<|0.0001|TWO_SIDED|95.0|6.6|16.5||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 16: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||16.5|6.6|< 0.0001
72484890|NCT03627767|144497464|SUPERIORITY||Difference in percentage|25.3|||<|0.0001|TWO_SIDED|95.0|19.4|31.2||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 16: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||31.2|19.4|< 0.0001
72484891|NCT03627767|144497464|SUPERIORITY||Difference in percentage|13.5|||||TWO_SIDED|95.0|6.6|20.4||||||Week 16: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||20.4|6.6|
72484892|NCT03627767|144497464|SUPERIORITY||Difference in percentage|12.9|||<|0.0001|TWO_SIDED|95.0|7.7|18.0||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 28: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||18.0|7.7|< 0.0001
72484893|NCT03627767|144497464|SUPERIORITY||Difference in percentage|26.0|||<|0.0001|TWO_SIDED|95.0|19.9|32.0||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 28: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||32.0|19.9|< 0.0001
72484894|NCT03627767|144497464|SUPERIORITY||Difference in percentage|13.4|||||TWO_SIDED|95.0|6.3|20.6||||||Week 28: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||20.6|6.3|
72484895|NCT03627767|144497464|SUPERIORITY||Difference in percentage|11.7|||<|0.0001|TWO_SIDED|95.0|6.5|16.8||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 40: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||16.8|6.5|< 0.0001
72484896|NCT03627767|144497464|SUPERIORITY||Difference in percentage|25.7|||<|0.0001|TWO_SIDED|95.0|19.6|31.8||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 40: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||31.8|19.6|< 0.0001
72484897|NCT03627767|144497464|SUPERIORITY||Difference in percentage|14.1|||||TWO_SIDED|95.0|7.0|21.2||||||Week 40: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||21.2|7.0|
72484898|NCT03627767|144497464|SUPERIORITY||Difference in percentage|14.6|||<|0.0001|TWO_SIDED|95.0|9.2|20.0||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 52: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||20.0|9.2|< 0.0001
72512241|NCT01830543|144554476|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.86||||0.625|TWO_SIDED|95.0|0.46|1.59|||Log Rank|||||1.59|0.46|0.625
72512242|NCT01830543|144554476|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.75||||0.374|TWO_SIDED|95.0|0.4|1.42|||Log Rank|||||1.42|0.4|0.374
72484899|NCT03627767|144497464|SUPERIORITY||Difference in percentage|24.5|||<|0.0001|TWO_SIDED|95.0|18.4|30.5||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 52: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||30.5|18.4|< 0.0001
72484900|NCT03627767|144497464|SUPERIORITY||Difference in percentage|10.0|||||TWO_SIDED|95.0|2.7|17.2||||||Week 52: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||17.2|2.7|
72484901|NCT03627767|144497465|SUPERIORITY||Difference in percentage|1.8|||=|0.6082|TWO_SIDED|95.0|-5.0|8.5||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 12: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||8.5|-5.0|= 0.6082
72484902|NCT03627767|144497465|SUPERIORITY||Difference in percentage|0.2|||=|0.964|TWO_SIDED|95.0|-6.7|7.0||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 12: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||7.0|-6.7|= 0.9640
72484903|NCT03627767|144497465|SUPERIORITY||Difference in percentage|-2.4|||||TWO_SIDED|95.0|-9.1|4.4||||||Week 12: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||4.4|-9.1|
72484904|NCT03627767|144497465|SUPERIORITY||Difference in percentage|38.9|||<|0.0001|TWO_SIDED|95.0|31.2|46.5||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 16: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||46.5|31.2|< 0.0001
72484905|NCT03627767|144497465|SUPERIORITY||Difference in percentage|59.7|||<|0.0001|TWO_SIDED|95.0|52.7|66.7||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 16: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||66.7|52.7|< 0.0001
72484906|NCT03627767|144497465|SUPERIORITY||Difference in percentage|20.9|||||TWO_SIDED|95.0|12.7|29.0||||||Week 16: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||29.0|12.7|
72484907|NCT03627767|144497465|SUPERIORITY||Difference in percentage|33.9|||<|0.0001|TWO_SIDED|95.0|26.6|41.2||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 28: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||41.2|26.6|< 0.0001
72484908|NCT03627767|144497465|SUPERIORITY||Difference in percentage|55.3|||<|0.0001|TWO_SIDED|95.0|48.2|62.3||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 28: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||62.3|48.2|< 0.0001
72484909|NCT03627767|144497465|SUPERIORITY||Difference in percentage|21.7|||||TWO_SIDED|95.0|13.2|30.2||||||Week 28: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||30.2|13.2|
72484910|NCT03627767|144497465|SUPERIORITY||Difference in percentage|29.7|||<|0.0001|TWO_SIDED|95.0|22.7|36.7||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 40: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||36.7|22.7|< 0.0001
72484911|NCT03627767|144497465|SUPERIORITY||Difference in percentage|45.5|||<|0.0001|TWO_SIDED|95.0|38.4|52.7||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 40: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||52.7|38.4|< 0.0001
72484912|NCT03627767|144497465|SUPERIORITY||Difference in percentage|16.0|||||TWO_SIDED|95.0|7.4|24.6||||||Week 40: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||24.6|7.4|
72484913|NCT03627767|144497465|SUPERIORITY||Difference in percentage|19.9|||<|0.0001|TWO_SIDED|95.0|13.0|26.8||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 52: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||26.8|13.0|< 0.0001
72512243|NCT01830543|144554477|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.07||||0.891|TWO_SIDED|95.0|0.39|2.96|||Log Rank|||||2.96|0.39|0.891
72484914|NCT03627767|144497465|SUPERIORITY||Difference in percentage|40.5|||<|0.0001|TWO_SIDED|95.0|32.8|48.1||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 52: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||48.1|32.8|< 0.0001
72512244|NCT01830543|144554477|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.36||||0.53|TWO_SIDED|95.0|0.52|3.58|||Log Rank|||||3.58|0.52|0.53
72624088|NCT05293314|144778521|OTHER|Specificity=number of true negative cases/(number of true negative cases+number of false positive cases) \* 100% The specificity is the rate of correctly judging non patients.We calculated the specificity of the breath test model to distinguish bronchiectasis from healthy people.The maximum percentage of the specificity is 100%. The higher the percentage is , the more specificity of the model.|Specificity|73.9|||||TWO_SIDED|95.0|56.0|91.9||||||Specificity=number of true negative cases/(number of true negative cases+number of false positive cases) \* 100% The specificity is the rate of correctly judging non patients.We calculated the specificity of the breath test model to distinguish bronchiectasis from healthy people.The maximum percentage of the specificity is 100%. The higher the percentage is , the more specificity of the model.||91.9|56|
72624089|NCT00835367|144778522|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Parametric analysis of variance (ANOVA)on AUC0-t, AUCinf and Cmax; geometric Confidence Intervals for AUC0-t, AUC0-inf and Cmax|Ratio of Least Squares Means|101.84||||||90.0|98.22|105.59|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||105.59|98.22|
72624090|NCT00835367|144778523|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Parametric analysis of variance (ANOVA)on AUC0-t, AUCinf and Cmax; geometric Confidence Intervals for AUC0-t, AUC0-inf and Cmax|Slope|102.53||||||90.0|99.71|105.44|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||105.44|99.71|
72624091|NCT00835367|144778524|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Parametric analysis of variance (ANOVA)on AUC0-t, AUCinf and Cmax; geometric Confidence Intervals for AUC0-t, AUC0-inf and Cmax|Ratio of Least Squares Means|102.49||||||90.0|99.75|105.3|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||105.30|99.75|
72402510|NCT01480076|144311683|SUPERIORITY_OR_OTHER|||||||0.4893|||||||mixed effect model|||Overall, PRMS. Mixed effect model for repeated measures with visit, baseline of percentage of work time missed due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.4893
72402511|NCT01480076|144311683|SUPERIORITY_OR_OTHER|||||||0.2166|||||||mixed effect model|||Month 3, RRMS. Mixed effect model for repeated measures with visit, baseline of percentage of work time missed due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.2166
72484915|NCT03627767|144497465|SUPERIORITY||Difference in percentage|20.9|||||TWO_SIDED|95.0|11.8|30.0||||||Week 52: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||30.0|11.8|
72484916|NCT03627767|144497468|SUPERIORITY||LSM difference|0.0|||=|0.9207|TWO_SIDED|95.0|-0.3|0.3|||Mixed Models Analysis|||Pruritus VAS: Week 12: The least squares mean (LSM) differences between treatment groups were derived from the statistical model. Mixed model repeated measure (MMRM) contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||0.3|-0.3|= 0.9207
72484917|NCT03627767|144497468|SUPERIORITY||LSM difference|0.0|||=|0.9998|TWO_SIDED|95.0|-0.3|0.3|||Mixed Models Analysis|||Pruritus VAS: Week 12: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||0.3|-0.3|= 0.9998
72624092|NCT00835367|144778525|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Parametric analysis of variance (ANOVA)on AUC0-t, AUCinf and Cmax; geometric Confidence Intervals for AUC0-t, AUC0-inf and Cmax|Ratio of Least Squares Means|91.79||||||90.0|84.83|99.32|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||99.32|84.83|
72624093|NCT00835367|144778526|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Parametric analysis of variance (ANOVA)on AUC0-t, AUCinf and Cmax; geometric Confidence Intervals for AUC0-t, AUC0-inf and Cmax|Ratio of Least Squares Means|95.85||||||90.0|92.54|99.27|||||Metabolite presented for informational purposes only.|||99.27|92.54|
72484918|NCT03627767|144497468|SUPERIORITY||LSM difference|0.0|||||TWO_SIDED|95.0|-0.3|0.3||||||Pruritus VAS: Week 12: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||0.3|-0.3|
72512245|NCT01830543|144554478|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.2||||0.79|TWO_SIDED|95.0|0.32|4.45|||Log Rank|||||4.45|0.32|0.79
72512246|NCT01830543|144554478|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.44||||0.574|TWO_SIDED|95.0|0.4|5.09|||Log Rank|||||5.09|0.4|0.574
72512247|NCT02059213|144554479|SUPERIORITY|||||||0.87|||||||Fisher Exact|Mid P-value||With 20 patients treated with ADT and 40 treated with ADT + palbociclib there is a 64.2% power to detect a 20% difference in proportions with a one-sided type I error of 0.10 using the mid p-value method of the Fisher's exact test.||||0.87
72624094|NCT00835367|144778527|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Parametric analysis of variance (ANOVA)on AUC0-t, AUCinf and Cmax; geometric Confidence Intervals for AUC0-t, AUC0-inf and Cmax|Ratio of Least Squares Means|100.28||||||90.0|98.3|102.3|||||Metabolite presented for informational purposes only|||102.30|98.30|
72624095|NCT00835367|144778528|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Parametric analysis of variance (ANOVA)on AUC0-t, AUCinf and Cmax; geometric Confidence Intervals for AUC0-t, AUC0-inf and Cmax|Ratio of Least Squares Means|102.74||||||90.0|100.35|105.19|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||105.19|100.35|
72402512|NCT01480076|144311683|SUPERIORITY_OR_OTHER|||||||0.4149|||||||mixed effect model|||Month 3, SPMS. Mixed effect model for repeated measures with visit, baseline of percentage of work time missed due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.4149
72512248|NCT02059213|144554481|SUPERIORITY|||||||0.92|||||||t-test, 2 sided|||||||0.92
72512249|NCT02059213|144554482|SUPERIORITY|||||||0.5|||||||Fisher Exact|Mid p-value||||||0.50
72512250|NCT02059213|144554483|SUPERIORITY|||||||0.72|||||||Log Rank|||||||0.72
72402513|NCT01480076|144311683|SUPERIORITY_OR_OTHER|||||||0.3849|||||||mixed effect model|||Month 3, PPMS. Mixed effect model for repeated measures with visit, baseline of percentage of work time missed due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.3849
72402514|NCT01480076|144311683|SUPERIORITY_OR_OTHER|||||||0.898|||||||mixed effect model|||Month 3, PRMS. Mixed effect model for repeated measures with visit, baseline of percentage of work time missed due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.8980
72402515|NCT01480076|144311683|SUPERIORITY_OR_OTHER|||||||0.0046|||||||mixed effect model|||Month 6, RRMS. Mixed effect model for repeated measures with visit, baseline of percentage of work time missed due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.0046
72402516|NCT01480076|144311683|SUPERIORITY_OR_OTHER|||||||0.0594|||||||mixed effect model|||Month 6, SPMS. Mixed effect model for repeated measures with visit, baseline of percentage of work time missed due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.0594
72402517|NCT01480076|144311683|SUPERIORITY_OR_OTHER|||||||0.2975|||||||mixed effect model|||Month 6, PPMS. Mixed effect model for repeated measures with visit, baseline of percentage of work time missed due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.2975
72402518|NCT01480076|144311683|SUPERIORITY_OR_OTHER|||||||0.7155|||||||mixed effect model|||Month 6, PRMS. Mixed effect model for repeated measures with visit, baseline of percentage of work time missed due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.7155
72402519|NCT01480076|144311683|SUPERIORITY_OR_OTHER|||||||0.507|||||||mixed effect model|||Month 9, RRMS. Mixed effect model for repeated measures with visit, baseline of percentage of work time missed due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.5070
72484919|NCT03627767|144497468|SUPERIORITY||LSM difference|-2.1|||<|0.0001|TWO_SIDED|95.0|-2.5|-1.7|||Mixed Models Analysis|||Pruritus VAS: Week 16: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-1.7|-2.5|< 0.0001
72512251|NCT02059213|144554484|SUPERIORITY|||||||0.76|||||||Log Rank|||||||0.76
72512252|NCT03583372|144554488|OTHER|Estimation of within treatment group change from Baseline|Least squares mean|-2.4|||||TWO_SIDED|95.0|-2.9|-2.0||||||||-2.0|-2.9|
72512253|NCT03583372|144554488|OTHER|Estimation of within treatment group change from Baseline|Least squares mean|-2.0|||||TWO_SIDED|95.0|-2.5|-1.5||||||||-1.5|-2.5|
72512254|NCT03583372|144554489|OTHER|Estimation of within treatment group change from Baseline|Least squares mean|-2.2|||||TWO_SIDED|95.0|-2.5|-1.9||||||||-1.9|-2.5|
72402520|NCT01480076|144311683|SUPERIORITY_OR_OTHER|||||||0.5848|||||||mixed effect model|||Month 9, SPMS. Mixed effect model for repeated measures with visit, baseline of percentage of work time missed due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.5848
72402521|NCT01480076|144311683|SUPERIORITY_OR_OTHER|||||||0.802|||||||mixed effect model|||Month 9, PPMS. Mixed effect model for repeated measures with visit, baseline of percentage of work time missed due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.8020
72402522|NCT01480076|144311683|SUPERIORITY_OR_OTHER|||||||0.254|||||||mixed effect model|||Month 9, PRMS. Mixed effect model for repeated measures with visit, baseline of percentage of work time missed due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.2540
72402523|NCT01480076|144311683|SUPERIORITY_OR_OTHER|||||||0.9057|||||||mixed effect model|||Month 12, RRMS. Mixed effect model for repeated measures with visit, baseline of percentage of work time missed due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.9057
72484920|NCT03627767|144497468|SUPERIORITY||LSM difference|-3.2|||<|0.0001|TWO_SIDED|95.0|-3.6|-2.8|||Mixed Models Analysis|||Pruritus VAS: Week 16: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-2.8|-3.6|< 0.0001
72512255|NCT03583372|144554489|OTHER|Estimation of within treatment group change from Baseline|Least squares mean|-1.7|||||TWO_SIDED|95.0|-2.0|-1.3||||||||-1.3|-2.0|
72512256|NCT03583372|144554490|OTHER|Estimation of within treatment group change from Baseline|Least squares mean|-3.4|||||TWO_SIDED|95.0|-4.0|-2.7||||||||-2.7|-4.0|
72512257|NCT03583372|144554490|OTHER|Estimation of within treatment group change from Baseline|Least squares mean|-3.2|||||TWO_SIDED|95.0|-4.0|-2.5||||||||-2.5|-4.0|
72512258|NCT03583372|144554491|OTHER|Estimation of within treatment group change from Baseline|Least squares mean|-2.5|||||TWO_SIDED|95.0|-2.8|-2.2||||||||-2.2|-2.8|
72512259|NCT03583372|144554491|OTHER|Estimation of within treatment group change from Baseline|Least squares mean|-1.9|||||TWO_SIDED|95.0|-2.3|-1.6||||||||-1.6|-2.3|
72484921|NCT03627767|144497468|SUPERIORITY||LSM difference|-1.1|||||TWO_SIDED|95.0|-1.4|-0.7||||||Pruritus VAS: Week 16: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-0.7|-1.4|
72484922|NCT03627767|144497468|SUPERIORITY||LSM difference|-1.4|||<|0.0001|TWO_SIDED|95.0|-2.0|-0.8|||Mixed Models Analysis|||Pruritus VAS: Week 28: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-0.8|-2.0|< 0.0001
72484923|NCT03627767|144497468|SUPERIORITY||LSM difference|-1.9|||<|0.0001|TWO_SIDED|95.0|-2.5|-1.3|||Mixed Models Analysis|||Pruritus VAS: Week 28: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-1.3|-2.5|< 0.0001
72484924|NCT03627767|144497468|SUPERIORITY||LSM difference|-0.5|||||TWO_SIDED|95.0|-0.9|-0.1||||||Pruritus VAS: Week 28: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-0.1|-0.9|
72484925|NCT03627767|144497468|SUPERIORITY||LSM difference|-1.0|||=|0.0039|TWO_SIDED|95.0|-1.7|-0.3|||Mixed Models Analysis|||Pruritus VAS: Week 40: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-0.3|-1.7|= 0.0039
72484926|NCT03627767|144497468|SUPERIORITY||LSM difference|-1.8|||<|0.0001|TWO_SIDED|95.0|-2.5|-1.2|||Mixed Models Analysis|||Pruritus VAS: Week 40: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-1.2|-2.5|< 0.0001
72484927|NCT03627767|144497468|SUPERIORITY||LSM difference|-0.8|||||TWO_SIDED|95.0|-1.3|-0.4||||||Pruritus VAS: Week 40: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-0.4|-1.3|
72484928|NCT03627767|144497468|SUPERIORITY||LSM difference|-0.5|||=|0.1488|TWO_SIDED|95.0|-1.2|0.2|||Mixed Models Analysis|||Pruritus VAS: Week 52: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||0.2|-1.2|= 0.1488
72484929|NCT03627767|144497468|SUPERIORITY||LSM difference|-1.3|||=|0.0003|TWO_SIDED|95.0|-2.0|-0.6|||Mixed Models Analysis|||Pruritus VAS: Week 52: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-0.6|-2.0|= 0.0003
72484930|NCT03627767|144497468|SUPERIORITY||LSM difference|-0.8|||||TWO_SIDED|95.0|-1.2|-0.3||||||Pruritus VAS: Week 52: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-0.3|-1.2|
72484931|NCT03627767|144497468|SUPERIORITY||LSM difference|0.0|||=|0.9294|TWO_SIDED|95.0|-0.2|0.2|||Mixed Models Analysis|||Sleep Loss VAS: Week 12: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||0.2|-0.2|= 0.9294
72484932|NCT03627767|144497468|SUPERIORITY||LSM difference|-0.1|||=|0.4081|TWO_SIDED|95.0|-0.3|0.1|||Mixed Models Analysis|||Sleep Loss VAS: Week 12: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||0.1|-0.3|= 0.4081
72512260|NCT01151046|144554493|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.26||||0.003|TWO_SIDED|95.0|0.11|0.63|||Log Rank|||||0.63|0.11|0.003
72512261|NCT01151046|144554493|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.41||||0.349|TWO_SIDED|95.0|0.69|2.88|||Log Rank|||||2.88|0.69|0.349
72512262|NCT02420223|144554507|SUPERIORITY|||||||0.017|||||||Regression, Logistic|||||||.017
72512263|NCT02420223|144554507|SUPERIORITY|||||||0.337|||||||Regression, Logistic|||||||0.337
72512264|NCT02420223|144554510|SUPERIORITY|||||||0.14|||||||t-test, 2 sided|||||||0.14
72512265|NCT02420223|144554511|SUPERIORITY|||||||0.41|||||||t-test, 2 sided|||||||0.41
72567503|NCT03728634|144666141|SUPERIORITY||||||<|0.001|||||||ANOVA|||Change From Baseline in Plasma TTR Levels Following Multiple-Dose Administration of ION-TTR-LRx at Day 99: 60 mg||||<0.001
72567504|NCT03728634|144666141|SUPERIORITY||||||<|0.001|||||||ANOVA|||Change From Baseline in Plasma TTR Levels Following Multiple-Dose Administration of ION-TTR-LRx at Day 99: 90 mg||||<0.001
72512266|NCT02420223|144554512|SUPERIORITY|||||||0.06|||||||Likelihood ration Chi-Square test|||||||0.06
72512267|NCT00980785|144554514|OTHER|Mann-Whitney test|Mean Difference (Final Values)|-22.5|STANDARD_DEVIATION|78.7||0.836|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.836
72512268|NCT00980785|144554514|OTHER|Mann-Whitney Test|Mean Difference (Final Values)|-31.71|STANDARD_DEVIATION|90.6||0.836|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.836
72512269|NCT00980785|144554515|OTHER|Mann-Whitney Test|Mean Difference (Final Values)|-0.1|STANDARD_DEVIATION|0.21||0.009|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.009
72512270|NCT00980785|144554515|OTHER|Mann-Whitney Test|Mean Difference (Final Values)|-0.63|STANDARD_DEVIATION|0.32||0.009|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.009
72512271|NCT00980785|144554516|OTHER|Mann-Whitney Test|Mean Difference (Final Values)|-0.7|STANDARD_DEVIATION|1.56||0.755|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.755
72567505|NCT03728634|144666141|SUPERIORITY|||||||0.036|||||||ANOVA|||Change From Baseline in Plasma TTR Levels Following Single-Dose Administration of ION-TTR-LRx at Day 29: 120 mg||||0.036
72402524|NCT01480076|144311683|SUPERIORITY_OR_OTHER|||||||0.9679|||||||mixed effect model|||Month 12, SPMS. Mixed effect model for repeated measures with visit, baseline of percentage of work time missed due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.9679
72402525|NCT01480076|144311683|SUPERIORITY_OR_OTHER|||||||0.5875|||||||mixed effect model|||Month 12, PPMS. Mixed effect model for repeated measures with visit, baseline of percentage of work time missed due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.5875
72402526|NCT01480076|144311683|SUPERIORITY_OR_OTHER|||||||0.744|||||||mixed effect model|||Month 12, PRMS. Mixed effect model for repeated measures with visit, baseline of percentage of work time missed due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.7440
72402527|NCT01480076|144311684|SUPERIORITY_OR_OTHER|||||||0.0032|||||||mixed effect model|||Overall, RRMS. Mixed effect model for repeated measures with visit, baseline of percentage of impairment while working due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.0032
72402528|NCT01480076|144311684|SUPERIORITY_OR_OTHER|||||||0.0828|||||||mixed effect model|||Overall, SPMS. Mixed effect model for repeated measures with visit, baseline of percentage of impairment while working due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.0828
72402529|NCT01480076|144311684|SUPERIORITY_OR_OTHER|||||||0.7756|||||||mixed effect model|||Overall, PPMS. Mixed effect model for repeated measures with visit, baseline of percentage of impairment while working due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.7756
72402530|NCT01480076|144311684|SUPERIORITY_OR_OTHER|||||||0.22|||||||mixed effect model|||Overall, PRMS. Mixed effect model for repeated measures with visit, baseline of percentage of impairment while working due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.2200
72402531|NCT01480076|144311684|SUPERIORITY_OR_OTHER|||||||0.0002|||||||mixed effect model|||Month 3, RRMS. Mixed effect model for repeated measures with visit, baseline of percentage of impairment while working due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.0002
72402532|NCT01480076|144311684|SUPERIORITY_OR_OTHER|||||||0.0061|||||||mixed effect model|||Month 3, SPMS. Mixed effect model for repeated measures with visit, baseline of percentage of impairment while working due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.0061
72484933|NCT03627767|144497468|SUPERIORITY||LSM difference|-0.1|||||TWO_SIDED|95.0|-0.3|0.1||||||Sleep Loss VAS: Week 12: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||0.1|-0.3|
72484934|NCT03627767|144497468|SUPERIORITY||LSM difference|-1.8|||<|0.0001|TWO_SIDED|95.0|-2.1|-1.4|||Mixed Models Analysis|||Sleep Loss VAS: Week 16: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-1.4|-2.1|< 0.0001
72484935|NCT03627767|144497468|SUPERIORITY||LSM difference|-2.3|||<|0.0001|TWO_SIDED|95.0|-2.7|-2.0|||Mixed Models Analysis|||Sleep Loss VAS: Week 16: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-2.0|-2.7|< 0.0001
72484936|NCT03627767|144497468|SUPERIORITY||LSM difference|-0.6|||||TWO_SIDED|95.0|-0.9|-0.2||||||Sleep Loss VAS: Week 16: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-0.2|-0.9|
72484937|NCT03627767|144497468|SUPERIORITY||LSM difference|-0.7|||=|0.0035|TWO_SIDED|95.0|-1.2|-0.2|||Mixed Models Analysis|||Sleep Loss VAS: Week 28: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-0.2|-1.2|= 0.0035
72484938|NCT03627767|144497468|SUPERIORITY||LSM difference|-1.2|||<|0.0001|TWO_SIDED|95.0|-1.6|-0.7|||Mixed Models Analysis|||Sleep Loss VAS: Week 28: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-0.7|-1.6|< 0.0001
72402533|NCT01480076|144311684|SUPERIORITY_OR_OTHER|||||||0.6258|||||||mixed effect model|||Month 3, PPMS. Mixed effect model for repeated measures with visit, baseline of percentage of impairment while working due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.6258
72402534|NCT01480076|144311684|SUPERIORITY_OR_OTHER|||||||0.6987|||||||mixed effect model|||Month 3, PRMS. Mixed effect model for repeated measures with visit, baseline of percentage of impairment while working due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.6987
72484939|NCT03627767|144497468|SUPERIORITY||LSM difference|-0.5|||||TWO_SIDED|95.0|-0.8|-0.1||||||Sleep Loss VAS: Week 28: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-0.1|-0.8|
72484940|NCT03627767|144497468|SUPERIORITY||LSM difference|-0.7|||=|0.0136|TWO_SIDED|95.0|-1.2|-0.1|||Mixed Models Analysis|||Sleep Loss VAS: Week 40: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-0.1|-1.2|= 0.0136
72484941|NCT03627767|144497468|SUPERIORITY||LSM difference|-1.1|||<|0.0001|TWO_SIDED|95.0|-1.6|-0.6|||Mixed Models Analysis|||Sleep Loss VAS: Week 40: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-0.6|-1.6|< 0.0001
72484942|NCT03627767|144497468|SUPERIORITY||LSM difference|-0.4|||||TWO_SIDED|95.0|-0.8|0.0||||||Sleep Loss VAS: Week 40: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||0.0|-0.8|
72484943|NCT03627767|144497468|SUPERIORITY||LSM difference|-0.3|||=|0.2887|TWO_SIDED|95.0|-1.0|0.3|||Mixed Models Analysis|||Sleep Loss VAS: Week 52: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||0.3|-1.0|= 0.2887
72484944|NCT03627767|144497468|SUPERIORITY||LSM difference|-1.0|||=|0.0025|TWO_SIDED|95.0|-1.6|-0.3|||Mixed Models Analysis|||Sleep Loss VAS: Week 52: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-0.3|-1.6|= 0.0025
72484945|NCT03627767|144497468|SUPERIORITY||LSM difference|-0.6|||||TWO_SIDED|95.0|-1.0|-0.2||||||Sleep Loss VAS: Week 52: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-0.2|-1.0|
72484946|NCT03627767|144497469|SUPERIORITY||Difference in percentage|1.0|||=|0.4244|TWO_SIDED|95.0|-1.4|3.4||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 12: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||3.4|-1.4|= 0.4244
72484947|NCT03627767|144497469|SUPERIORITY||Difference in percentage|-0.3|||=|0.8092|TWO_SIDED|95.0|-3.1|2.4||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 12: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||2.4|-3.1|= 0.8092
72484948|NCT03627767|144497469|SUPERIORITY||Difference in percentage|-1.5|||||TWO_SIDED|95.0|-4.1|1.0||||||Week 12: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||1.0|-4.1|
72484949|NCT03627767|144497469|SUPERIORITY||Difference in percentage|46.7|||<|0.0001|TWO_SIDED|95.0|39.2|54.2||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 16: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||54.2|39.2|< 0.0001
72484950|NCT03627767|144497469|SUPERIORITY||Difference in percentage|63.6|||<|0.0001|TWO_SIDED|95.0|57.2|70.0||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 16: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||70.0|57.2|< 0.0001
72484951|NCT03627767|144497469|SUPERIORITY||Difference in percentage|17.0|||||TWO_SIDED|95.0|10.4|23.5||||||Week 16: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||23.5|10.4|
72484952|NCT03627767|144497469|SUPERIORITY||Difference in percentage|41.3|||<|0.0001|TWO_SIDED|95.0|33.9|48.7||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 28: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||48.7|33.9|< 0.0001
72484953|NCT03627767|144497469|SUPERIORITY||Difference in percentage|59.9|||<|0.0001|TWO_SIDED|95.0|53.1|66.7||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 28: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||66.7|53.1|< 0.0001
72484954|NCT03627767|144497469|SUPERIORITY||Difference in percentage|18.7|||||TWO_SIDED|95.0|10.8|26.6||||||Week 28: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||26.6|10.8|
72484955|NCT03627767|144497469|SUPERIORITY||Difference in percentage|37.0|||<|0.0001|TWO_SIDED|95.0|29.6|44.4||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 40: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||44.4|29.6|< 0.0001
72567506|NCT03728634|144666142|SUPERIORITY||||||<|0.001|||||||ANOVA|||Change From Baseline in Plasma RBP4 Levels Following Multiple-Dose Administration of ION-TTR-LRx at Day 29: 45 mg||||<0.001
72567507|NCT03728634|144666142|SUPERIORITY||||||<|0.001|||||||ANOVA|||Change From Baseline in Plasma RBP4 Levels Following Multiple-Dose Administration of ION-TTR-LRx at Day 29: 60 mg||||<0.001
72567508|NCT03728634|144666142|SUPERIORITY||||||<|0.001|||||||ANOVA|||Change From Baseline in Plasma RBP4 Levels Following Multiple-Dose Administration of ION-TTR-LRx at Day 29: 90 mg||||<0.001
72484956|NCT03627767|144497469|SUPERIORITY||Difference in percentage|54.6|||<|0.0001|TWO_SIDED|95.0|47.6|61.7||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 40: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||61.7|47.6|< 0.0001
72484957|NCT03627767|144497469|SUPERIORITY||Difference in percentage|17.7|||||TWO_SIDED|95.0|9.4|26.0||||||Week 40: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||26.0|9.4|
72512272|NCT00980785|144554516|OTHER|Mann-Whitney test|Mean Difference (Final Values)|-0.29|STANDARD_DEVIATION|1.23||0.755|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.755
72512273|NCT00980785|144554517|OTHER|Mann-Whitney test|Mean Difference (Final Values)|1.7|STANDARD_DEVIATION|8.9||0.491|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.491
72512274|NCT00980785|144554517|OTHER|Mann-Whitney test|Mean Difference (Final Values)|-1.8|STANDARD_DEVIATION|2.2||0.491|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.491
72512275|NCT05142332|144554528|SUPERIORITY||Adjusted absolute difference|11.9|||<|0.001|TWO_SIDED|95.0|4.5|19.3|||Regression, Logistic|||||19.3|4.5|<0.001
72512276|NCT05142332|144554529|SUPERIORITY||Adjusted absolute difference|7.9|||<|0.001|TWO_SIDED|95.0|1.7|14.1|||Regression, Logistic|||||14.1|1.7|<0.001
72567509|NCT03728634|144666142|SUPERIORITY||||||<|0.001|||||||ANOVA|||Change From Baseline in Plasma RBP4 Levels Following Multiple-Dose Administration of ION-TTR-LRx at Day 99: 45 mg||||<0.001
72567510|NCT03728634|144666142|SUPERIORITY||||||<|0.001|||||||ANOVA|||Change From Baseline in Plasma RBP4 Levels Following Multiple-Dose Administration of ION-TTR-LRx at Day 99: 60 mg||||<0.001
72484958|NCT03627767|144497469|SUPERIORITY||Difference in percentage|30.0|||<|0.0001|TWO_SIDED|95.0|22.6|37.4||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 52: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||37.4|22.6|< 0.0001
72512277|NCT01980706|144554558|SUPERIORITY||Mean Difference (Net)|4.16||||0.018|TWO_SIDED|||||Threshold for significance is \<.05|Mixed Models Analysis||Overall, treatment effect F value testing under the null hypothesis the equality of the average outcome over the three groups.|||||0.018
72512278|NCT01980706|144554559|SUPERIORITY||Mean Difference (Net)|3.68||||0.028|TWO_SIDED|||||Threshold for significance is \<.05|Mixed Models Analysis||Overall, treatment effect F value testing under the null hypothesis the equality of the average outcome over the three groups.|||||0.028
72512279|NCT01980706|144554560|SUPERIORITY||Mean Difference (Net)|0.65||||0.52|TWO_SIDED|||||Threshold for significance is \<.05|Mixed Models Analysis||Overall, treatment effect F value testing under the null hypothesis the equality of the average outcome over the three groups.|||||0.52
72512280|NCT01980706|144554561|SUPERIORITY||Mean Difference (Net)|0.84||||0.43|TWO_SIDED|||||Threshold for significance is \<.05|Mixed Models Analysis||Overall, treatment effect F value testing under the null hypothesis the equality of the average outcome over the three groups.|||||0.43
72567511|NCT03728634|144666142|SUPERIORITY||||||<|0.001|||||||ANOVA|||Change From Baseline in Plasma RBP4 Levels Following Multiple-Dose Administration of ION-TTR-LRx at Day 99: 90 mg||||<0.001
72567512|NCT03728634|144666142|SUPERIORITY|||||||0.036|||||||Wilcoxon Rank Sum Exact Test (2-sided)|||Change From Baseline in Plasma RBP4 Levels Following Single-Dose Administration of ION-TTR-LRx at Day 29: 120 mg||||0.036
72512281|NCT01980706|144554562|SUPERIORITY||Mean Difference (Final Values)|0.52||||0.6|TWO_SIDED|||||Threshold for significance is \<.05|ANCOVA|Adjusted for baseline|Estimated parameter is the overall treatment main effect F statistic from the fitted ANCOVA model assessing the null hypothesis of equal values across the three groups|||||0.60
72512282|NCT01980706|144554563|SUPERIORITY||Table probability for Fisher's Exact|0.002||||0.07|TWO_SIDED|||||Threshold for significance is \<.05|Fisher Exact|||||||0.07
72512283|NCT01100307|144554587|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.85||||0.0003|TWO_SIDED|95.0|1.92|12.28||Significance level of test in the comparison between pegaptanib sodium 0.3 mg and sham was set to 0.05.|Cochran-Mantel-Haenszel|Stratification factors (HbA1c and baseline visual acuity categories)||The null hypothesis was to assume that there was no difference between the pegaptanib sodium and sham injection groups. The alternative was to assume that there was difference between the pegaptanib sodium and sham injection groups.||12.28|1.92|0.0003
72567513|NCT04295135|144666150|SUPERIORITY||Mean Difference (Net)|0.002|STANDARD_ERROR_OF_MEAN|0.001|<|0.05|TWO_SIDED|||||A multi-level linear probability model that included patient demographics, clinician random effects, and indicator variables for (a) site; (b) treatment and control clinicians; and (c) pre-/post-OneSheet access.|Regression, Linear|Model also included an interaction term for treatment and post-OneSheet access.|The coefficient estimates the causal effect of OneSheet on our outcomes. Unit of analysis was patient visit.|||||<0.05
72567514|NCT04295135|144666151|SUPERIORITY||Median Difference (Net)|0.007|STANDARD_ERROR_OF_MEAN|0.001|<|0.01|TWO_SIDED|||||A multi-level linear probability model that included patient demographics, clinician random effects, and indicator variables for (a) site; (b) treatment and control clinicians; and (c) pre-/post-OneSheet access.|Regression, Linear|Model also included an interaction term for treatment and post-OneSheet access.|The coefficient estimates the causal effect of OneSheet on our outcomes. Unit of analysis was patient visit.|||||<0.01
72576894|NCT00261443|144680709|SUPERIORITY_OR_OTHER_LEGACY|||||||0.868||95.0|||||Wilcoxon Rank Sum Test|||Week 52 LOCF Treatment Comparison; Aripiprazole/Placebo||||0.868
72402535|NCT01480076|144311684|SUPERIORITY_OR_OTHER|||||||0.0025|||||||mixed effect model|||Month 6, RRMS. Mixed effect model for repeated measures with visit, baseline of percentage of impairment while working due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.0025
72484959|NCT03627767|144497469|SUPERIORITY||Difference in percentage|50.9|||<|0.0001|TWO_SIDED|95.0|43.8|58.1||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 52: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||58.1|43.8|< 0.0001
72484960|NCT03627767|144497469|SUPERIORITY||Difference in percentage|21.1|||||TWO_SIDED|95.0|12.8|29.5||||||Week 52: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||29.5|12.8|
72512284|NCT01100307|144554588|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.52||||0.0006|TWO_SIDED|95.0|1.1|3.94||Significance level of test in the comparison between pegaptanib sodium 0.3 mg and sham was set to 0.05.|ANCOVA|Based on an analysis of covariance with treatment as a factor and stratification factors (HbA1c and baseline visual acuity categories) as covariates.||Comparison at Week 6: The null hypothesis was to assume that there was no difference between the pegaptanib sodium and sham injection groups. The alternative was to assume that there was difference between the pegaptanib sodium and sham injection groups.||3.94|1.10|0.0006
72512285|NCT01100307|144554588|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.69||||0.0001|TWO_SIDED|95.0|1.81|5.58||Significance level of test in the comparison between pegaptanib sodium 0.3 mg and sham was set to 0.05.|ANCOVA|Based on an analysis of covariance with treatment as a factor and stratification factors (HbA1c and baseline visual acuity categories) as covariates.||Comparison at Week 12: The null hypothesis was to assume that there was no difference between the pegaptanib sodium and sham injection groups. The alternative was to assume that there was difference between the pegaptanib sodium and sham injection groups.||5.58|1.81|0.0001
72512286|NCT01100307|144554588|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.65||||0.0096|TWO_SIDED|95.0|0.65|4.65||Significance level of test in the comparison between pegaptanib sodium 0.3 mg and sham was set to 0.05.|ANCOVA|Based on an analysis of covariance with treatment as a factor and stratification factors (HbA1c and baseline visual acuity categories) as covariates.||Comparison at Week 18: The null hypothesis was to assume that there was no difference between the pegaptanib sodium and sham injection groups. The alternative was to assume that there was difference between the pegaptanib sodium and sham injection groups.||4.65|0.65|0.0096
72512287|NCT01100307|144554588|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.26|||<|0.0001|TWO_SIDED|95.0|2.19|6.32||Significance level of test in the comparison between pegaptanib sodium 0.3 mg and sham was set to 0.05.|ANCOVA|Based on an analysis of covariance with treatment as a factor and stratification factors (HbA1c and baseline visual acuity categories) as covariates.||Comparison at Week 24: The null hypothesis was to assume that there was no difference between the pegaptanib sodium and sham injection groups. The alternative was to assume that there was difference between the pegaptanib sodium and sham injection groups.||6.32|2.19|<0.0001
72512288|NCT04436822|144554611|SUPERIORITY||Intercept from ANCOVA as agreement rate|88.9|||<|0.05|TWO_SIDED|90.0|87.1|90.7|||ANCOVA|A generalized estimating equation model was used, considering correlation structure of day of sensor wear (1-7).||||90.7|87.1|<0.05
72512289|NCT04436822|144554611|SUPERIORITY||Intercept from ANCOVA as agreement rate|87.5|||<|0.05|TWO_SIDED|90.0|85.4|89.7|||ANCOVA|A generalized estimating equation model was used, considering correlation structure of day of sensor wear (1-7).||||89.7|85.4|<0.05
72512290|NCT04436822|144554611|SUPERIORITY||Intercept from ANCOVA as agreement rate|87.9|||<|0.05|TWO_SIDED|90.0|85.8|89.9|||ANCOVA|A generalized estimating equation model was used, considering correlation structure of day of sensor wear (1-7).||||89.9|85.8|<0.05
72512291|NCT00406640|144554668|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.67||||0.243||95.0|-0.46|1.81|||Mixed Models Analysis|Mixed Models Repeated Measures (MMRM) with baseline score as a covariant and factors for center, week and treatment.|DVS SR adjusted mean change minus ESC adjusted mean change.|DVS SR compared with ESC||1.81|-0.46|0.243
72512292|NCT00406640|144554669|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.608||||0.077||95.0|0.4|0.92|||Chi-squared|Logistic regression model with treatment and site as factors and baseline score as a covariant.|Estimated odds ratio of DVS SR to ESC. Odd ratio adjusted for baseline, treatment and site.|DVS SR compared with ESC.||0.92|0.40|0.077
72512293|NCT00406640|144554670|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.571||||0.0054||95.0|0.39|0.85|||Chi-squared|Logistic regression model with treatment and site as factors and baseline score as a covariant.|Estimated odds ratio of DVS SR to ESC. Odds ratio adjusted for baseline, treatment and site.|DVS SR compared with ESC.||0.85|0.39|0.0054
72512294|NCT00406640|144554671|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.12||||0.26||95.0|-0.09|0.33|||Mixed Models Analysis|Mixed Models Repeated Measures (MMRM) with baseline score as a covariant and factors for center, week and treatment.|DVS SR minus ESC adjusted mean|DVS SR compared with ESC||0.33|-0.09|0.260
72512295|NCT00406640|144554672|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.14||||0.239||95.0|-0.09|0.37|||Mixed Models Analysis|Mixed Models Repeated Measures (MMRM) with baseline score as a covariant and factors for center, week and treatment.|DVS SR minus ESC adjusted mean|||0.37|-0.09|0.239
72512296|NCT00406640|144554673|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.37||||0.516||95.0|-0.75|1.49|||Mixed Models Analysis|Mixed model Repeated Measures (MMRM) analysis adjusted mean score for baseline score, time and center.|DVS SR adjusted mean change minus ESC adjusted mean change.|DVS SR compared to ESC||1.49|-0.75|0.516
72512297|NCT00406640|144554674|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.01||||0.635||95.0|-0.03|0.06|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) with treatment, time and site as factors and baseline as covariant.|DVS SR adjusted mean change minus ESC adjusted mean change|DVS SR compared to ESC||0.06|-0.03|0.635
72512298|NCT00406640|144554675|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.12||||0.702||95.0|0.63|2.0|||Chi-squared||Estimated odds ratio of DVS SR to ESC. Odd ratio adjusted for baseline, treatment and site.|DVS SR compared with ESC.||2.00|0.63|0.702
72484961|NCT03627767|144497470|SUPERIORITY||Difference in percentage|1.4|||=|0.7232|TWO_SIDED|95.0|-6.1|8.8||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 12: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||8.8|-6.1|= 0.7232
72484962|NCT03627767|144497470|SUPERIORITY||Difference in percentage|-2.2|||=|0.5694|TWO_SIDED|95.0|-9.8|5.4||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 12: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||5.4|-9.8|= 0.5694
72484963|NCT03627767|144497470|SUPERIORITY||Difference in percentage|-3.7|||||TWO_SIDED|95.0|-11.2|3.8||||||Week 12: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||3.8|-11.2|
72484964|NCT03627767|144497470|SUPERIORITY||Difference in percentage|29.0|||<|0.0001|TWO_SIDED|95.0|22.2|35.8||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 16: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||35.8|22.2|< 0.0001
72484965|NCT03627767|144497470|SUPERIORITY||Difference in percentage|57.9|||<|0.0001|TWO_SIDED|95.0|51.2|64.5||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 16: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||64.5|51.2|< 0.0001
72484966|NCT03627767|144497470|SUPERIORITY||Difference in percentage|28.9|||||TWO_SIDED|95.0|20.8|37.0||||||Week 16: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||37.0|20.8|
72402536|NCT01480076|144311684|SUPERIORITY_OR_OTHER|||||||0.0021|||||||mixed effect model|||Month 6, SPMS. Mixed effect model for repeated measures with visit, baseline of percentage of impairment while working due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.0021
72484967|NCT03627767|144497470|SUPERIORITY||Difference in percentage|30.5|||<|0.0001|TWO_SIDED|95.0|23.9|37.2||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 28: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||37.2|23.9|< 0.0001
72512299|NCT00406640|144554676|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.34||||0.234||95.0|0.83|2.16|||Chi-squared||Estimated odds ratio of DVS SR to ESC. Odd ratio adjusted for baseline, treatment and site.|DVS SR compared with ESC.||2.16|0.83|0.234
72512300|NCT00406640|144554680|SUPERIORITY_OR_OTHER_LEGACY|||||||0.927||95.0|||||t-test, 2 sided|||DVS SR vs. ESC: end of therapy||||0.927
72512301|NCT00406640|144554680|SUPERIORITY_OR_OTHER_LEGACY|||||||0.055||95.0|||||t-test, 2 sided|||DVS SR vs. ESC: after 1 week of taper||||0.055
72512302|NCT00406640|144554680|SUPERIORITY_OR_OTHER_LEGACY|||||||0.025||95.0|||||t-test, 2 sided|||DVS SR vs. ESC: after 2 weeks of taper||||0.025
72512303|NCT00406640|144554680|SUPERIORITY_OR_OTHER_LEGACY|||||||0.653||95.0|||||t-test, 2 sided|||DVS SR vs. ESC: after \> 2 weeks of taper||||0.653
72484968|NCT03627767|144497470|SUPERIORITY||Difference in percentage|48.9|||<|0.0001|TWO_SIDED|95.0|42.1|55.6||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 28: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||55.6|42.1|< 0.0001
72484969|NCT03627767|144497470|SUPERIORITY||Difference in percentage|18.2|||||TWO_SIDED|95.0|9.8|26.6||||||Week 28: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||26.6|9.8|
72512304|NCT00762372|144554700|NON_INFERIORITY|Time to extubation = treatment group + surgical site +surgery time|Mean Difference (Final Values)|-4.6|STANDARD_ERROR_OF_MEAN|1.0|||TWO_SIDED|95.0|-6.6|-2.7||||||||-2.7|-6.6|
72512305|NCT00762372|144554701|NON_INFERIORITY|"Adjusted means of time from the end of study drug inhalation to extubation in the BLM-240 N2O group and sevoflurane group, which were obtained by analysis of covariance with surgical site and surgery time as covariates, were used to verify the non-inferiority of BLM-240 to the comparator sevoflurane, with a delta = 1.0 (minute) and significance level alpha = 2.5% (one-sided)."||||||0.15|||||||t-test, 2 sided|||||||0.1500
72512306|NCT00762372|144554702|NON_INFERIORITY|Two-sample t-test||||||0.0001|||||||t-test, 2 sided|||||||0.0001
72512307|NCT00762372|144554706|NON_INFERIORITY|Fisher's exact test||||||0.3113|||||||Fisher Exact|||||||0.3113
72512308|NCT00762372|144554708|NON_INFERIORITY|Fisher's exact test||||||1|||||||Fisher Exact|||||||1.0000
72512309|NCT03364335|144554712|OTHER|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline body weight as the covariate. Treatment A is used as the reference group.||||||0.5461|||||||ANCOVA|||||||0.5461
72512310|NCT03364335|144554712|OTHER|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline body weight as the covariate. Treatment A is used as the reference group.||||||0.0364|||||||ANCOVA|||||||0.0364
72512311|NCT03364335|144554712|OTHER|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline body weight as the covariate. Treatment A is used as the reference group.||||||0.0156|||||||ANCOVA|||||||0.0156
72512312|NCT03364335|144554712|OTHER|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline body weight as the covariate. Treatment A is used as the reference group.||||||0.0349|||||||ANCOVA|||||||0.0349
72402537|NCT01480076|144311684|SUPERIORITY_OR_OTHER|||||||0.4385|||||||mixed effect model|||Month 6, PPMS. Mixed effect model for repeated measures with visit, baseline of percentage of impairment while working due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.4385
72402538|NCT01480076|144311684|SUPERIORITY_OR_OTHER|||||||0.2275|||||||mixed effect model|||Month 6, PRMS. Mixed effect model for repeated measures with visit, baseline of percentage of impairment while working due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.2275
72402539|NCT01480076|144311684|SUPERIORITY_OR_OTHER|||||||0.0446|||||||mixed effect model|||Month 9, RRMS. Mixed effect model for repeated measures with visit, baseline of percentage of impairment while working due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.0446
72402540|NCT01480076|144311684|SUPERIORITY_OR_OTHER|||||||0.5757|||||||mixed effect model|||Month 9, SPMS. Mixed effect model for repeated measures with visit, baseline of percentage of impairment while working due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.5757
72484970|NCT03627767|144497470|SUPERIORITY||Difference in percentage|25.0|||<|0.0001|TWO_SIDED|95.0|18.4|31.5||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 40: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||31.5|18.4|< 0.0001
72484971|NCT03627767|144497470|SUPERIORITY||Difference in percentage|39.6|||<|0.0001|TWO_SIDED|95.0|32.7|46.5||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 40: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||46.5|32.7|< 0.0001
72484972|NCT03627767|144497470|SUPERIORITY||Difference in percentage|14.5|||||TWO_SIDED|95.0|6.3|22.8||||||Week 40: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||22.8|6.3|
72484973|NCT03627767|144497470|SUPERIORITY||Difference in percentage|24.7|||<|0.0001|TWO_SIDED|95.0|18.1|31.2||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 52: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||31.2|18.1|< 0.0001
72484974|NCT03627767|144497470|SUPERIORITY||Difference in percentage|38.5|||<|0.0001|TWO_SIDED|95.0|31.6|45.3||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 52: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||45.3|31.6|< 0.0001
72484975|NCT03627767|144497470|SUPERIORITY||Difference in percentage|13.9|||||TWO_SIDED|95.0|5.6|22.3||||||Week 52: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||22.3|5.6|
72484976|NCT03627767|144497478|SUPERIORITY||Difference in percentage|3.0|||=|0.4815|TWO_SIDED|95.0|-5.3|11.3||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 12: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||11.3|-5.3|= 0.4815
72484977|NCT03627767|144497478|SUPERIORITY||Difference in percentage|-1.8|||=|0.6748|TWO_SIDED|95.0|-10.3|6.6||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 12: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||6.6|-10.3|= 0.6748
72484978|NCT03627767|144497478|SUPERIORITY||Difference in percentage|-5.1|||||TWO_SIDED|95.0|-13.4|3.2||||||Week 12: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||3.2|-13.4|
72512313|NCT03364335|144554713|OTHER|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline body weight as the covariate. Treatment A is used as the reference group.||||||0.5348|||||||ANCOVA|||||||0.5348
72512314|NCT03364335|144554713|OTHER|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline body weight as the covariate. Treatment A is used as the reference group.||||||0.0379|||||||ANCOVA|||||||0.0379
72512315|NCT03364335|144554713|OTHER|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline body weight as the covariate. Treatment A is used as the reference group.||||||0.0215|||||||ANCOVA|||||||0.0215
72402541|NCT01480076|144311684|SUPERIORITY_OR_OTHER|||||||0.8936|||||||mixed effect model|||Month 9, PPMS. Mixed effect model for repeated measures with visit, baseline of percentage of impairment while working due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.8936
72402542|NCT01480076|144311684|SUPERIORITY_OR_OTHER|||||||0.5675|||||||mixed effect model|||Month 9, PRMS. Mixed effect model for repeated measures with visit, baseline of percentage of impairment while working due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.5675
72567515|NCT04295135|144666152|SUPERIORITY||Mean Difference (Net)|0.022|STANDARD_ERROR_OF_MEAN|0.008|<|0.01|TWO_SIDED|||||A multi-level linear probability model that included patient demographics, clinician random effects, and indicator variables for (a) site; (b) treatment and control clinicians; and (c) pre-/post-OneSheet access.|Regression, Linear|Model also included an interaction term for treatment and post-OneSheet access.|The coefficient estimates the causal effect of OneSheet on our outcomes. Unit of analysis was patient visit.|||||<0.01
72567516|NCT04295135|144666153|SUPERIORITY||Median Difference (Net)|-0.005|STANDARD_ERROR_OF_MEAN|0.006|>|0.05|TWO_SIDED|||||A multi-level linear probability model that included patient demographics, clinician random effects, and indicator variables for (a) site; (b) treatment and control clinicians; and (c) pre-/post-OneSheet access.|Regression, Linear|Model also included an interaction term for treatment and post-OneSheet access.|The coefficient estimates the causal effect of OneSheet on our outcomes. Unit of analysis was patient visit.|||||>0.05
72567517|NCT04295135|144666154|SUPERIORITY||Median Difference (Net)|-0.005|STANDARD_ERROR_OF_MEAN|0.001|<|0.01|TWO_SIDED|||||A multi-level linear probability model that included patient demographics, clinician random effects, and indicator variables for (a) site; (b) treatment and control clinicians; and (c) pre-/post-OneSheet access.|Regression, Linear|Model also included an interaction term for treatment and post-OneSheet access.|The coefficient estimates the causal effect of OneSheet on our outcomes. Unit of analysis was patient visit.|||||<0.01
72567518|NCT04295135|144666155|SUPERIORITY||Median Difference (Net)|-0.002|STANDARD_ERROR_OF_MEAN|0.003|>|0.05|TWO_SIDED|||||A multi-level linear probability model that included patient demographics, clinician random effects, and indicator variables for (a) site; (b) treatment and control clinicians; and (c) pre-/post-OneSheet access.|Regression, Linear|Model also included an interaction term for treatment and post-OneSheet access.|The coefficient estimates the causal effect of OneSheet on our outcomes. Unit of analysis was patient visit.|||||>0.05
72567519|NCT01517659|144666159|OTHER||Mean Difference (Final Values)|2.61|STANDARD_DEVIATION|2.29|||TWO_SIDED|95.0|2.23|3.27||||||||3.27|2.23|
72567520|NCT03835325|144666167|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||"The sample size calculation was based on the following hypothesis test:~H0: there is no improvement in memory capacity between the initial (VS) and final (VF) assessments, assessed by the self-efficacy factor of the MIAr questionnaire.~H1: there is an improvement in memory capacity between the initial (VS) and final (VF) assessments, assessed by the self-efficacy factor of the MIAr questionnaire.~or H0: AUTO-EF (VF) - AUTO-EF (VS) ≤ 0 H1: AUTO-EF (VF) - AUTO-EF (VS)\> 0"||||<0.001
72567521|NCT03212794|144666182|SUPERIORITY||||||=|0.87||||||Threshold for significance p\<0.05|Chi-squared|||||||=0.87
72567522|NCT03212794|144666183|SUPERIORITY||||||=|0.82||||||Threshold for significance p\<0.05|Chi-squared|||||||=0.82
72567523|NCT03212794|144666184|OTHER||||||=|0.92||||||Threshold for significance p\<0.05|Log Rank|If no event occurred, the data from those individuals were right censored.||||||=0.92
72567524|NCT03212794|144666185|OTHER||||||=|0.85||||||Threshold for significance p\<0.05|Log Rank|If no event occurred, the data from those individuals were right censored.||||||=0.85
72567525|NCT01901874|144666186|OTHER|"Acceptable performance: favorably exclude PG=16.9% with 95.1% confidence.~Wa = expected weight (proportion) anatomic = 35% Pa = CEA expected anatomic MAE = 11% Wc = expected weight (proportion) comorbid = 65% Pc = CEA expected comorbid MAE = 14% D = noninferiority delta = 4%~PG = 0.35 x 11% + 0.65 x 14% + 4% = 16.9%"|Weighted binomial proportion|0.0448|STANDARD_ERROR_OF_MEAN|0.0241|<|1e-05|ONE_SIDED|95.1||0.0846||A priori 1-sided alpha = 0.049 (from simulation) to ensure overall type-1 error rate ≤ 0.05.|Binomial test (normal approximation)||Weighted by expected fractions of anatomic and comorbid high risk subjects (35% and 65%, respectively). Standard error based on H0.|"Test null hypothesis of equal or greater proportion with 1-year MAE compared to a performance goal (PG).~H0: P ≥ 16.9% vs H1: P \< 16.9%, where P is the true proportion of CAS subjects with 1-year MAE and 16.9% is the PG based on outcomes reported for patients treated with carotid endarterectomy (CEA).~N=280 subjects provide ≥90% power to exclude PG with 95.1% confidence if P=10.2% under H1."||0.0846||<0.00001
72567526|NCT01901874|144666194|OTHER||Cumulative probability|0.018|||||TWO_SIDED|95.0|0.007|0.047|||||Kaplan-Meier product-limit method (Greenwood's formula for standard error)|||0.047|0.007|
72567527|NCT01901874|144666195|OTHER||Cumulative probability|0.022|||||TWO_SIDED|95.0|0.009|0.052|||||Kaplan-Meier product-limit method (Greenwood's formula for standard error)|||0.052|0.009|
72567528|NCT04632706|144666196|OTHER|||||||0.803||||||If the p-value is more than 0.05 then dose proportionality can not be confirmed.|Mixed Models Analysis|||Assessment of dose proportionality on D2 and D28||||0.803
72567529|NCT04632706|144666198|OTHER|||||||0.689||||||If the p-value is more than 0.05 then dose proportionality can not be confirmed.|Mixed Models Analysis|||Assessment of dose proportionality on D2 and D28||||0.689
72567530|NCT00560937|144666206|SUPERIORITY_OR_OTHER|||||||0.048|||||||t-test, 2 sided|||T-test of change scores, pregnenolone vs. placebo post-treatment compared to baseline.||||.048
72567531|NCT00560937|144666207|SUPERIORITY_OR_OTHER|||||||0.79||95.0|||||t-test, 2 sided|||||||0.79
72567532|NCT00560937|144666208|SUPERIORITY_OR_OTHER|||||||0.22||95.0|||||t-test, 2 sided|||||||0.22
72567533|NCT00560937|144666209|SUPERIORITY_OR_OTHER|||||||1|||||||t-test, 2 sided|||T-test of change scores, pregnenolone compared to placebo post-treatment vs. pre-randomization.||||1.0
72567534|NCT00560937|144666210|SUPERIORITY_OR_OTHER|||||||0.014||95.0|||||t-test, 2 sided|||||||0.014
72567535|NCT01138111|144666212|SUPERIORITY_OR_OTHER|||||||0.0001|||||||Wilcoxon (Mann-Whitney)|||The baseline neocortical SUVR in those subjects who progressed to AD over the 2 year follow-up was compared to the neocortical SUVR of those that did not progress by a Wilcoxon-Mann-Whitney test.||||0.0001
72567536|NCT01138111|144666212|SUPERIORITY_OR_OTHER|||||||0.0011|||||||Wilcoxon (Mann-Whitney)|||The 12 month neocortical SUVR in those subjects who progressed to AD over the 2 year follow-up was compared to the neocortical SUVR of those that did not progress by a Wilcoxon-Mann-Whitney test.||||0.0011
72567537|NCT01138111|144666212|SUPERIORITY_OR_OTHER|||||||0.0008|||||||Wilcoxon (Mann-Whitney)|||The 24 month neocortical SUVR in those subjects who progressed to AD over the 2 year follow-up was compared to the neocortical SUVR of those that did not progress by a Wilcoxon-Mann-Whitney test.||||0.0008
72567538|NCT00653991|144666234|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<.001
72567539|NCT01846273|144666236|NON_INFERIORITY|pre-defined non-inferiority margin of 5 letters|Least Squares Mean|3.2|||<|0.001|ONE_SIDED|95.0|0.38||||ANCOVA||||||0.38|<0.001
72567540|NCT01846273|144666237|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||||||<0.0001
72484979|NCT03627767|144497478|SUPERIORITY||Difference in percentage|24.0|||<|0.0001|TWO_SIDED|95.0|17.8|30.3||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 16: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||30.3|17.8|< 0.0001
72484980|NCT03627767|144497478|SUPERIORITY||Difference in percentage|42.3|||<|0.0001|TWO_SIDED|95.0|35.6|49.0||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 16: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||49.0|35.6|< 0.0001
72484981|NCT03627767|144497478|SUPERIORITY||Difference in percentage|18.4|||||TWO_SIDED|95.0|10.2|26.6||||||Week 16: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions||26.6|10.2|
72484982|NCT03627767|144497478|SUPERIORITY||Difference in percentage|24.6|||<|0.0001|TWO_SIDED|95.0|18.2|31.0||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 28: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||31.0|18.2|< 0.0001
72484983|NCT03627767|144497478|SUPERIORITY||Difference in percentage|40.5|||<|0.0001|TWO_SIDED|95.0|33.7|47.3||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 28: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||47.3|33.7|< 0.0001
72484984|NCT03627767|144497478|SUPERIORITY||Difference in percentage|15.9|||||TWO_SIDED|95.0|7.6|24.1||||||Week 28: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||24.1|7.6|
72484985|NCT03627767|144497478|SUPERIORITY||Difference in percentage|18.8|||<|0.0001|TWO_SIDED|95.0|12.6|25.1||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 40: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||25.1|12.6|< 0.0001
72484986|NCT03627767|144497478|SUPERIORITY||Difference in percentage|34.5|||<|0.0001|TWO_SIDED|95.0|27.6|41.5||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 40: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||41.5|27.6|< 0.0001
72484987|NCT03627767|144497478|SUPERIORITY||Difference in percentage|15.6|||||TWO_SIDED|95.0|7.5|23.7||||||Week 40: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||23.7|7.5|
72484988|NCT03627767|144497478|SUPERIORITY||Difference in percentage|18.7|||<|0.0001|TWO_SIDED|95.0|12.4|25.0||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 52: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||25.0|12.4|< 0.0001
72484989|NCT03627767|144497478|SUPERIORITY||Difference in percentage|32.3|||<|0.0001|TWO_SIDED|95.0|25.4|39.2||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 52: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||39.2|25.4|< 0.0001
72484990|NCT03627767|144497478|SUPERIORITY||Difference in percentage|13.7|||||TWO_SIDED|95.0|5.6|21.7||||||Week 52: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||21.7|5.6|
72484991|NCT03627767|144497479|SUPERIORITY||LSM difference|0.1|||=|0.7373|TWO_SIDED|95.0|-0.5|0.7|||Mixed Models Analysis|||Week 12: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||0.7|-0.5|= 0.7373
72484992|NCT03627767|144497479|SUPERIORITY||LSM difference|-0.1|||=|0.8092|TWO_SIDED|95.0|-0.7|0.5|||Mixed Models Analysis|||Week 12: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||0.5|-0.7|= 0.8092
72484993|NCT03627767|144497479|SUPERIORITY||LSM difference|-0.2|||||TWO_SIDED|95.0|-0.8|0.4||||||Week 12: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||0.4|-0.8|
72484994|NCT03627767|144497479|SUPERIORITY||LSM difference|-5.1|||<|0.0001|TWO_SIDED|95.0|-6.1|-4.0|||Mixed Models Analysis|||Week 16: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-4.0|-6.1|< 0.0001
72484995|NCT03627767|144497479|SUPERIORITY||LSM difference|-6.6|||<|0.0001|TWO_SIDED|95.0|-7.6|-5.5|||Mixed Models Analysis|||Week 16: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-5.5|-7.6|< 0.0001
72402543|NCT01480076|144311684|SUPERIORITY_OR_OTHER|||||||0.2539|||||||mixed effect model|||Month 12, RRMS. Mixed effect model for repeated measures with visit, baseline of percentage of impairment while working due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.2539
72402544|NCT01480076|144311684|SUPERIORITY_OR_OTHER|||||||0.6673|||||||mixed effect model|||Month 12, SPMS. Mixed effect model for repeated measures with visit, baseline of percentage of impairment while working due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.6673
72402545|NCT01480076|144311684|SUPERIORITY_OR_OTHER|||||||0.0849|||||||mixed effect model|||Month 12, PPMS. Mixed effect model for repeated measures with visit, baseline of percentage of impairment while working due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.0849
72402546|NCT01480076|144311684|SUPERIORITY_OR_OTHER|||||||0.1187|||||||mixed effect model|||Month 12, PRMS. Mixed effect model for repeated measures with visit, baseline of percentage of impairment while working due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.1187
72402547|NCT01480076|144311685|SUPERIORITY_OR_OTHER|||||||0.0022|||||||mixed effect model|||Overall, RRMS. Mixed effect model for repeated measures with visit, baseline of percentage of overall work impairment due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.0022
72402548|NCT01480076|144311685|SUPERIORITY_OR_OTHER|||||||0.0299|||||||mixed effect model|||Overall, SPMS. Mixed effect model for repeated measures with visit, baseline of percentage of overall work impairment due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.0299
72402549|NCT01480076|144311685|SUPERIORITY_OR_OTHER|||||||0.8135|||||||mixed effect model|||Overall, PPMS. Mixed effect model for repeated measures with visit, baseline of percentage of overall work impairment due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.8135
72402550|NCT01480076|144311685|SUPERIORITY_OR_OTHER|||||||0.3526|||||||mixed effect model|||Overall, PRMS. Mixed effect model for repeated measures with visit, baseline of percentage of overall work impairment due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.3526
72402551|NCT01480076|144311685|SUPERIORITY_OR_OTHER|||||||0.0001|||||||mixed effect model|||Month 3, RRMS. Mixed effect model for repeated measures with visit, baseline of percentage of overall work impairment due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.0001
72402552|NCT01480076|144311685|SUPERIORITY_OR_OTHER|||||||0.0039|||||||mixed effect model|||Month 3, SPMS. Mixed effect model for repeated measures with visit, baseline of percentage of overall work impairment due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.0039
72402553|NCT01480076|144311685|SUPERIORITY_OR_OTHER|||||||0.6924|||||||mixed effect model|||Month 3, PPMS. Mixed effect model for repeated measures with visit, baseline of percentage of overall work impairment due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.6924
72402554|NCT01480076|144311685|SUPERIORITY_OR_OTHER|||||||0.7639|||||||mixed effect model|||Month 3, PRMS. Mixed effect model for repeated measures with visit, baseline of percentage of overall work impairment due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.7639
72402555|NCT01480076|144311685|SUPERIORITY_OR_OTHER|||||||0.0013|||||||mixed effect model|||Month 6, RRMS. Mixed effect model for repeated measures with visit, baseline of percentage of overall work impairment due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.0013
72402556|NCT01480076|144311685|SUPERIORITY_OR_OTHER|||||||0.0011|||||||mixed effect model|||Month 6, SPMS. Mixed effect model for repeated measures with visit, baseline of percentage of overall work impairment due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.0011
72484996|NCT03627767|144497479|SUPERIORITY||LSM difference|-1.5|||||TWO_SIDED|95.0|-2.4|-0.6||||||Week 16: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-0.6|-2.4|
72484997|NCT03627767|144497479|SUPERIORITY||LSM difference|-4.0|||<|0.0001|TWO_SIDED|95.0|-5.3|-2.7|||Mixed Models Analysis|||Week 28: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-2.7|-5.3|< 0.0001
72484998|NCT03627767|144497479|SUPERIORITY||LSM difference|-5.2|||<|0.0001|TWO_SIDED|95.0|-6.4|-3.9|||Mixed Models Analysis|||Week 28: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-3.9|-6.4|< 0.0001
72484999|NCT03627767|144497479|SUPERIORITY||LSM difference|-1.2|||||TWO_SIDED|95.0|-2.1|-0.3||||||Week 28: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-0.3|-2.1|
72485000|NCT03627767|144497479|SUPERIORITY||LSM difference|-1.9|||=|0.015|TWO_SIDED|95.0|-3.5|-0.4|||Mixed Models Analysis|||Week 40: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-0.4|-3.5|= 0.0150
72402557|NCT01480076|144311685|SUPERIORITY_OR_OTHER|||||||0.434|||||||mixed effect model|||Month 6, PPMS. Mixed effect model for repeated measures with visit, baseline of percentage of overall work impairment due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.4340
72402558|NCT01480076|144311685|SUPERIORITY_OR_OTHER|||||||0.4224|||||||mixed effect model|||Month 6, PRMS. Mixed effect model for repeated measures with visit, baseline of percentage of overall work impairment due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.4224
72485001|NCT03627767|144497479|SUPERIORITY||LSM difference|-3.2|||<|0.0001|TWO_SIDED|95.0|-4.7|-1.7|||Mixed Models Analysis|||Week 40: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-1.7|-4.7|< 0.0001
72512316|NCT03364335|144554713|OTHER|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline body weight as the covariate. Treatment A is used as the reference group.||||||0.0464|||||||ANCOVA|||||||0.0464
72512317|NCT03364335|144554714|OTHER|Pearson's Chi Square Test is used. Fisher exact test is used when any expected cell count is less than 5. Treatment A is used as the reference group.||||||1|||||||Chi-squared|||||||1.0000
72512318|NCT03364335|144554714|OTHER|Pearson's Chi Square Test is used. Fisher exact test is used when any expected cell count is less than 5. Treatment A is used as the reference group.||||||0.2646|||||||Chi-squared|||||||0.2646
72512319|NCT03364335|144554714|OTHER|Pearson's Chi Square Test is used. Fisher exact test is used when any expected cell count is less than 5. Treatment A is used as the reference group.||||||0.0749|||||||Chi-squared|||||||0.0749
72402559|NCT01480076|144311685|SUPERIORITY_OR_OTHER|||||||0.1628|||||||mixed effect model|||Month 9, RRMS. Mixed effect model for repeated measures with visit, baseline of percentage of overall work impairment due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.1628
72402560|NCT01480076|144311685|SUPERIORITY_OR_OTHER|||||||0.5666|||||||mixed effect model|||Month 9, SPMS. Mixed effect model for repeated measures with visit, baseline of percentage of overall work impairment due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.5666
72485002|NCT03627767|144497479|SUPERIORITY||LSM difference|-1.3|||||TWO_SIDED|95.0|-2.3|-0.3||||||Week 40: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-0.3|-2.3|
72485003|NCT03627767|144497479|SUPERIORITY||LSM difference|-0.8|||=|0.3616|TWO_SIDED|95.0|-2.4|0.9|||Mixed Models Analysis|||Week 52: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||0.9|-2.4|= 0.3616
72512320|NCT03364335|144554714|OTHER|Pearson's Chi Square Test is used. Fisher exact test is used when any expected cell count is less than 5. Treatment A is used as the reference group.||||||0.6758|||||||Chi-squared|||||||0.6758
72512321|NCT03364335|144554715|OTHER|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline waist circumference as the covariate. Treatment A is used as the reference group.||||||0.9656|||||||ANCOVA|||||||0.9656
72512322|NCT03364335|144554715|OTHER|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline waist circumference as the covariate. Treatment A is used as the reference group.||||||0.4254|||||||ANCOVA|||||||0.4254
72512323|NCT03364335|144554715|OTHER|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline waist circumference as the covariate. Treatment A is used as the reference group.||||||0.1276|||||||ANCOVA|||||||0.1276
72512324|NCT03364335|144554715|OTHER|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline waist circumference as the covariate. Treatment A is used as the reference group.||||||0.5937|||||||ANCOVA|||||||0.5937
72512325|NCT03364335|144554716|OTHER|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline fasting plasma lipid as the covariate. Treatment A is used as the reference group.||||||0.601|||||||ANCOVA|||||||0.6010
72576895|NCT00261443|144680709|SUPERIORITY_OR_OTHER_LEGACY|||||||0.284||95.0|||||Wilcoxon Rank Sum Test|||Highest Value Treatment Comparison; Aripiprazole/Placebo||||0.284
72576896|NCT00261443|144680709|SUPERIORITY_OR_OTHER_LEGACY|||||||0.481||95.0|||||Wilcoxon Rank Sum Test|||Lowest Value Treatment Comparison; Aripiprazole/Placebo||||0.481
72576897|NCT00261443|144680710|SUPERIORITY_OR_OTHER_LEGACY|||||||0.184||95.0|||||Wilcoxon Rank Sum Test|||Baseline Treatment Comparison; Aripiprazole/Placebo||||0.184
72576898|NCT00261443|144680710|SUPERIORITY_OR_OTHER_LEGACY|||||||0.073||95.0|||||Wilcoxon Rank Sum Test|||Week 52 LOCF Treatment Comparison; Aripiprazole/Placebo||||0.073
72485004|NCT03627767|144497479|SUPERIORITY||LSM difference|-2.7|||=|0.0012|TWO_SIDED|95.0|-4.3|-1.1|||Mixed Models Analysis|||Week 52: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-1.1|-4.3|= 0.0012
72485005|NCT03627767|144497479|SUPERIORITY||LSM difference|-1.9|||||TWO_SIDED|95.0|-3.0|-0.8||||||Week 52: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-0.8|-3.0|
72512326|NCT03364335|144554716|OTHER|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline fasting plasma lipid as the covariate. Treatment A is used as the reference group.||||||0.6513|||||||ANCOVA|||||||0.6513
72512327|NCT03364335|144554716|OTHER|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline fasting plasma lipid as the covariate. Treatment A is used as the reference group.||||||0.4354|||||||ANCOVA|||||||0.4354
72512328|NCT03364335|144554716|OTHER|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline fasting plasma lipid as the covariate. Treatment A is used as the reference group.||||||0.031|||||||ANCOVA|||||||0.0310
72512329|NCT03364335|144554717|OTHER|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline fasting plasma lipid as the covariate. Treatment A is used as the reference group.||||||0.4644|||||||ANCOVA|||||||0.4644
72512330|NCT03364335|144554717|OTHER|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline fasting plasma lipid as the covariate. Treatment A is used as the reference group.||||||0.8573|||||||ANCOVA|||||||0.8573
72512331|NCT03364335|144554717|OTHER|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline fasting plasma lipid as the covariate. Treatment A is used as the reference group.||||||0.8167|||||||ANCOVA|||||||0.8167
72624096|NCT00835367|144778529|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Parametric analysis of variance (ANOVA)on AUC0-t, AUCinf and Cmax; geometric Confidence Intervals for AUC0-t, AUC0-inf and Cmax|Ratio of Least Squares Means|102.72||||||90.0|100.3|105.2|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||105.20|100.30|
72485006|NCT03627767|144497480|SUPERIORITY||LSM difference|0.6|||=|0.3339|TWO_SIDED|95.0|-0.6|1.8|||Mixed Models Analysis|||Week 12: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||1.8|-0.6|= 0.3339
72485007|NCT03627767|144497480|SUPERIORITY||LSM difference|0.5|||=|0.4653|TWO_SIDED|95.0|-0.8|1.7|||Mixed Models Analysis|||Week 12: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||1.7|-0.8|= 0.4653
72485008|NCT03627767|144497480|SUPERIORITY||LSM difference|-0.1|||||TWO_SIDED|95.0|-1.3|1.1||||||Week 12: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||1.1|-1.3|
72485009|NCT03627767|144497480|SUPERIORITY||LSM difference|-4.3|||<|0.0001|TWO_SIDED|95.0|-6.2|-2.3|||Mixed Models Analysis|||Week 16: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-2.3|-6.2|< 0.0001
72485010|NCT03627767|144497480|SUPERIORITY||LSM difference|-6.2|||<|0.0001|TWO_SIDED|95.0|-8.2|-4.3|||Mixed Models Analysis|||Week 16: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-4.3|-8.2|< 0.0001
72485011|NCT03627767|144497480|SUPERIORITY||LSM difference|-2.0|||||TWO_SIDED|95.0|-3.6|-0.3||||||Week 16: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-0.3|-3.6|
72512332|NCT03364335|144554717|OTHER|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline fasting plasma lipid as the covariate. Treatment A is used as the reference group.||||||0.9223|||||||ANCOVA|||||||0.9223
72512333|NCT03364335|144554718|OTHER|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline fasting plasma lipid as the covariate. Treatment A is used as the reference group.||||||0.6574|||||||ANCOVA|||||||0.6574
72512334|NCT03364335|144554718|OTHER|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline fasting plasma lipid as the covariate. Treatment A is used as the reference group.||||||0.8971|||||||ANCOVA|||||||0.8971
72512335|NCT03364335|144554718|OTHER|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline fasting plasma lipid as the covariate. Treatment A is used as the reference group.||||||0.6317|||||||ANCOVA|||||||0.6317
72512336|NCT03364335|144554718|OTHER|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline fasting plasma lipid as the covariate. Treatment A is used as the reference group.||||||0.0341|||||||ANCOVA|||||||0.0341
72512337|NCT03364335|144554719|OTHER|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline fasting plasma lipid as the covariate. Treatment A is used as the reference group.||||||0.372|||||||ANCOVA|||||||0.3720
72624097|NCT00835367|144778530|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Parametric analysis of variance (ANOVA)on AUC0-t, AUCinf and Cmax; geometric Confidence Intervals for AUC0-t, AUC0-inf and Cmax|Ratio of Least Squares Means|100.28||||||90.0|98.25|102.35|||||Metabolite presented for informational purposes only.|||102.35|98.25|
72485012|NCT03627767|144497480|SUPERIORITY||LSM difference|0.1|||=|0.9083|TWO_SIDED|95.0|-1.8|2.1|||Mixed Models Analysis|||Week 28: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||2.1|-1.8|= 0.9083
72485013|NCT03627767|144497480|SUPERIORITY||LSM difference|-1.1|||=|0.2439|TWO_SIDED|95.0|-3.0|0.8|||Mixed Models Analysis|||Week 28: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||0.8|-3.0|= 0.2439
72485014|NCT03627767|144497480|SUPERIORITY||LSM difference|-1.2|||||TWO_SIDED|95.0|-2.6|0.1||||||Week 28: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||0.1|-2.6|
72485015|NCT03627767|144497480|SUPERIORITY||LSM difference|-0.3|||=|0.7405|TWO_SIDED|95.0|-2.4|1.7|||Mixed Models Analysis|||Week 40: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||1.7|-2.4|= 0.7405
72485016|NCT03627767|144497480|SUPERIORITY||LSM difference|-2.1|||=|0.041|TWO_SIDED|95.0|-4.1|-0.1|||Mixed Models Analysis|||Week 40: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-0.1|-4.1|= 0.0410
72485017|NCT03627767|144497480|SUPERIORITY||LSM difference|-1.7|||||TWO_SIDED|95.0|-3.1|-0.4||||||Week 40: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-0.4|-3.1|
72485018|NCT03627767|144497480|SUPERIORITY||LSM difference|-1.0|||=|0.4026|TWO_SIDED|95.0|-3.5|1.4|||Mixed Models Analysis|||Week 52: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||1.4|-3.5|= 0.4026
72485019|NCT03627767|144497480|SUPERIORITY||LSM difference|-1.9|||=|0.0944|TWO_SIDED|95.0|-4.2|0.3|||Mixed Models Analysis|||Week 52: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||0.3|-4.2|= 0.0944
72485020|NCT03627767|144497480|SUPERIORITY||LSM difference|-0.9|||||TWO_SIDED|95.0|-2.5|0.7||||||Week 52: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||0.7|-2.5|
72485021|NCT03627767|144497481|SUPERIORITY||Hazard Ratio (HR)|0.27|||<|0.0001|TWO_SIDED|95.0|0.211|0.341||A stratified log-rank test with age group and disease severity as stratification variables was performed to evaluate p-value.|Log Rank|||A Cox regression model with treatment, age group and disease severity as stratification covariates was used to estimate the hazard ratio and the corresponding 95% confidence interval (CI).||0.341|0.211|< 0.0001
72485022|NCT03627767|144497481|SUPERIORITY||Hazard Ratio (HR)|0.1|||<|0.0001|TWO_SIDED|95.0|0.07|0.136||A stratified log-rank test with age group and disease severity as stratification variables was performed to evaluate P value.|Log Rank|||A Cox regression model with treatment, age group and disease severity as stratification covariates was used to estimate the hazard ratio and the corresponding 95% CI.||0.136|0.070|< 0.0001
72485023|NCT03627767|144497481|SUPERIORITY||Hazard Ratio (HR)|0.36|||<|0.0001|TWO_SIDED|95.0|0.255|0.516||A stratified log-rank test with age group and disease severity as stratification variables was performed to evaluate P value.|Log Rank|||A Cox regression model with treatment, age group and disease severity as stratification covariates was used to estimate the hazard ratio and the corresponding 95% CI.||0.516|0.255|< 0.0001
72485024|NCT03627767|144497482|SUPERIORITY||LSM difference|0.1|||=|0.7556|TWO_SIDED|95.0|-0.4|0.6|||Mixed Models Analysis|||Week 12: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||0.6|-0.4|= 0.7556
72485025|NCT03627767|144497482|SUPERIORITY||LSM difference|0.1|||=|0.7484|TWO_SIDED|95.0|-0.4|0.6|||Mixed Models Analysis|||Week 12: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||0.6|-0.4|= 0.7484
72485026|NCT03627767|144497482|SUPERIORITY||LSM difference|0.0|||||TWO_SIDED|95.0|-0.5|0.5||||||Week 12: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||0.5|-0.5|
72485027|NCT03627767|144497482|SUPERIORITY||LSM difference|-1.1|||<|0.0001|TWO_SIDED|95.0|-1.6|-0.6|||Mixed Models Analysis|||Week 16: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-0.6|-1.6|< 0.0001
72512338|NCT03364335|144554719|OTHER|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline fasting plasma lipid as the covariate. Treatment A is used as the reference group.||||||0.2302|||||||ANCOVA|||||||0.2302
72512339|NCT03364335|144554719|OTHER|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline fasting plasma lipid as the covariate. Treatment A is used as the reference group.||||||0.1377|||||||ANCOVA|||||||0.1377
72485028|NCT03627767|144497482|SUPERIORITY||LSM difference|-1.4|||<|0.0001|TWO_SIDED|95.0|-1.9|-0.9|||Mixed Models Analysis|||Week 16: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-0.9|-1.9|< 0.0001
72485029|NCT03627767|144497482|SUPERIORITY||LSM difference|-0.3|||||TWO_SIDED|95.0|-0.7|0.1||||||Week 16: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||0.1|-0.7|
72485030|NCT03627767|144497482|SUPERIORITY||LSM difference|-0.6|||=|0.0242|TWO_SIDED|95.0|-1.2|-0.1|||Mixed Models Analysis|||Week 28: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-0.1|-1.2|= 0.0242
72485031|NCT03627767|144497482|SUPERIORITY||LSM difference|-0.9|||=|0.0012|TWO_SIDED|95.0|-1.4|-0.4|||Mixed Models Analysis|||Week 28: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-0.4|-1.4|= 0.0012
72485032|NCT03627767|144497482|SUPERIORITY||LSM difference|-0.3|||||TWO_SIDED|95.0|-0.6|0.1||||||Week 28: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||0.1|-0.6|
72485033|NCT03627767|144497482|SUPERIORITY||LSM difference|-0.6|||=|0.124|TWO_SIDED|95.0|-1.3|0.2|||Mixed Models Analysis|||Week 40: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||0.2|-1.3|= 0.1240
72485034|NCT03627767|144497482|SUPERIORITY||LSM difference|-0.9|||=|0.0107|TWO_SIDED|95.0|-1.6|-0.2|||Mixed Models Analysis|||Week 40: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-0.2|-1.6|= 0.0107
72485035|NCT03627767|144497482|SUPERIORITY||LSM difference|-0.3|||||TWO_SIDED|95.0|-0.8|0.1||||||Week 40: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||0.1|-0.8|
72485036|NCT03627767|144497482|SUPERIORITY||LSM difference|-0.4|||=|0.3139|TWO_SIDED|95.0|-1.1|0.3|||Mixed Models Analysis|||Week 52: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||0.3|-1.1|= 0.3139
72485037|NCT03627767|144497482|SUPERIORITY||LSM difference|-0.6|||=|0.0853|TWO_SIDED|95.0|-1.3|0.1|||Mixed Models Analysis|||Week 52: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||0.1|-1.3|= 0.0853
72485038|NCT03627767|144497482|SUPERIORITY||LSM difference|-0.2|||||TWO_SIDED|95.0|-0.7|0.2||||||Week 52: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||0.2|-0.7|
72485039|NCT03627767|144497483|SUPERIORITY||LSM difference|0.4|||=|0.0674|TWO_SIDED|95.0|0.0|0.8|||Mixed Models Analysis|||Week 12: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||0.8|0.0|= 0.0674
72512340|NCT03364335|144554719|OTHER|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline fasting plasma lipid as the covariate. Treatment A is used as the reference group.||||||0.4295|||||||ANCOVA|||||||0.4295
72512341|NCT03364335|144554720|OTHER|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline Fasting Plasma Glucose as the covariate. Treatment A is used as the reference group.||||||0.6726|||||||ANCOVA|||||||0.6726
72512342|NCT03364335|144554720|OTHER|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline Fasting Plasma Glucose as the covariate. Treatment A is used as the reference group.||||||0.7934|||||||ANCOVA|||||||0.7934
72512343|NCT03364335|144554720|OTHER|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline Fasting Plasma Glucose as the covariate. Treatment A is used as the reference group.||||||0.5485|||||||ANCOVA|||||||0.5485
72485040|NCT03627767|144497483|SUPERIORITY||LSM difference|0.3|||=|0.1437|TWO_SIDED|95.0|-0.1|0.7|||Mixed Models Analysis|||Week 12: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||0.7|-0.1|= 0.1437
72485041|NCT03627767|144497483|SUPERIORITY||LSM difference|-0.1|||||TWO_SIDED|95.0|-0.5|0.3||||||Week 12: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||0.3|-0.5|
72485042|NCT03627767|144497483|SUPERIORITY||LSM difference|-1.4|||<|0.0001|TWO_SIDED|95.0|-1.8|-0.9|||Mixed Models Analysis|||Week 16: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-0.9|-1.8|< 0.0001
72485043|NCT03627767|144497483|SUPERIORITY||LSM difference|-1.4|||<|0.0001|TWO_SIDED|95.0|-1.8|-0.9|||Mixed Models Analysis|||Week 16: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-0.9|-1.8|< 0.0001
72512344|NCT03364335|144554720|OTHER|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline Fasting Plasma Glucose as the covariate. Treatment A is used as the reference group.||||||0.3676|||||||ANCOVA|||||||0.3676
72512345|NCT03364335|144554721|OTHER|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline HbA1c as the covariate. Treatment A is used as the reference group.||||||0.1653|||||||ANCOVA|||||||0.1653
72576899|NCT00261443|144680710|SUPERIORITY_OR_OTHER_LEGACY|||||||0.02||95.0|||||Wilcoxon Rank Sum Test|||Highest Value Treatment Comparison; Aripiprazole/Placebo||||0.020
72624098|NCT01892189|144778533|SUPERIORITY_OR_OTHER||Least Squares (LS) Mean Difference|-0.2348|STANDARD_ERROR_OF_MEAN|0.20458||0.259|TWO_SIDED|95.0|-0.6506|0.1809|||ANOVA||Difference between least square means of TAK-063 3 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Left Anterior Cingulate Cortex: Values were obtained using analysis of variance (ANOVA) model with sequence, period, regimen and participant nested within sequence as factors by regions of interest.||0.1809|-0.6506|0.259
72624099|NCT01892189|144778533|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.0367|STANDARD_ERROR_OF_MEAN|0.22075||0.869|TWO_SIDED|95.0|-0.4853|0.4119|||ANOVA||Difference between least square means of TAK-063 10 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Left Anterior Cingulate Cortex: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.4119|-0.4853|0.869
72485044|NCT03627767|144497483|SUPERIORITY||LSM difference|0.0|||||TWO_SIDED|95.0|-0.4|0.4||||||Week 16: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||0.4|-0.4|
72485045|NCT03627767|144497483|SUPERIORITY||LSM difference|-0.4|||=|0.1136|TWO_SIDED|95.0|-1.0|0.1|||Mixed Models Analysis|||Week 28: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||0.1|-1.0|= 0.1136
72485046|NCT03627767|144497483|SUPERIORITY||LSM difference|-0.6|||=|0.0276|TWO_SIDED|95.0|-1.1|-0.1|||Mixed Models Analysis|||Week 28: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-0.1|-1.1|= 0.0276
72485047|NCT03627767|144497483|SUPERIORITY||LSM difference|-0.2|||||TWO_SIDED|95.0|-0.5|0.2||||||Week 28: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||0.2|-0.5|
72485048|NCT03627767|144497483|SUPERIORITY||LSM difference|-0.9|||=|0.0108|TWO_SIDED|95.0|-1.5|-0.2|||Mixed Models Analysis|||Week 40: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-0.2|-1.5|= 0.0108
72485049|NCT03627767|144497483|SUPERIORITY||LSM difference|-0.6|||=|0.0677|TWO_SIDED|95.0|-1.3|0.0|||Mixed Models Analysis|||Week 40: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||0.0|-1.3|= 0.0677
72485050|NCT03627767|144497483|SUPERIORITY||LSM difference|0.3|||||TWO_SIDED|95.0|-0.2|0.7||||||Week 40: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||0.7|-0.2|
72402561|NCT01480076|144311685|SUPERIORITY_OR_OTHER|||||||0.8315|||||||mixed effect model|||Month 9, PPMS. Mixed effect model for repeated measures with visit, baseline of percentage of overall work impairment due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.8315
72485051|NCT03627767|144497483|SUPERIORITY||LSM difference|-0.5|||=|0.132|TWO_SIDED|95.0|-1.1|0.1|||Mixed Models Analysis|||Week 52: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||0.1|-1.1|= 0.1320
72485052|NCT03627767|144497483|SUPERIORITY||LSM difference|-0.3|||=|0.2975|TWO_SIDED|95.0|-0.9|0.3|||Mixed Models Analysis|||Week 52: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||0.3|-0.9|= 0.2975
72485053|NCT03627767|144497483|SUPERIORITY||LSM difference|0.2|||||TWO_SIDED|95.0|-0.2|0.6||||||Week 52: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||0.6|-0.2|
72485054|NCT03627767|144497484|SUPERIORITY||LSM difference|-0.4|||=|0.3531|TWO_SIDED|95.0|-1.3|0.4|||Mixed Models Analysis|||Week 12: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||0.4|-1.3|= 0.3531
72485055|NCT03627767|144497484|SUPERIORITY||LSM difference|0.0|||=|0.9282|TWO_SIDED|95.0|-0.8|0.9|||Mixed Models Analysis|||Week 12: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||0.9|-0.8|= 0.9282
72485056|NCT03627767|144497484|SUPERIORITY||LSM difference|0.4|||||TWO_SIDED|95.0|-0.4|1.3||||||Week 12: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||1.3|-0.4|
72485057|NCT03627767|144497484|SUPERIORITY||LSM difference|-6.1|||<|0.0001|TWO_SIDED|95.0|-7.3|-5.0|||Mixed Models Analysis|||Week 16: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-5.0|-7.3|< 0.0001
72512346|NCT03364335|144554721|OTHER|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline HbA1c as the covariate. Treatment A is used as the reference group.||||||0.197|||||||ANCOVA|||||||0.1970
72485058|NCT03627767|144497484|SUPERIORITY||LSM difference|-9.2|||<|0.0001|TWO_SIDED|95.0|-10.3|-8.1|||Mixed Models Analysis|||Week 16: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-8.1|-10.3|< 0.0001
72485059|NCT03627767|144497484|SUPERIORITY||LSM difference|-3.1|||||TWO_SIDED|95.0|-4.0|-2.1||||||Week 16: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-2.1|-4.0|
72485060|NCT03627767|144497484|SUPERIORITY||LSM difference|-4.6|||<|0.0001|TWO_SIDED|95.0|-6.2|-2.9|||Mixed Models Analysis|||Week 28: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-2.9|-6.2|< 0.0001
72485061|NCT03627767|144497484|SUPERIORITY||LSM difference|-6.7|||<|0.0001|TWO_SIDED|95.0|-8.3|-5.1|||Mixed Models Analysis|||Week 28: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-5.1|-8.3|< 0.0001
72485062|NCT03627767|144497484|SUPERIORITY||LSM difference|-2.1|||||TWO_SIDED|95.0|-3.3|-0.9||||||Week 28: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-0.9|-3.3|
72485063|NCT03627767|144497484|SUPERIORITY||LSM difference|-2.6|||=|0.0082|TWO_SIDED|95.0|-4.5|-0.7|||Mixed Models Analysis|||Week 40: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-0.7|-4.5|= 0.0082
72485064|NCT03627767|144497484|SUPERIORITY||LSM difference|-5.5|||<|0.0001|TWO_SIDED|95.0|-7.4|-3.6|||Mixed Models Analysis|||Week 40: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-3.6|-7.4|< 0.0001
72485065|NCT03627767|144497484|SUPERIORITY||LSM difference|-2.9|||||TWO_SIDED|95.0|-4.2|-1.6||||||Week 40: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-1.6|-4.2|
72485066|NCT03627767|144497484|SUPERIORITY||LSM difference|-2.4|||=|0.0313|TWO_SIDED|95.0|-4.5|-0.2|||Mixed Models Analysis|||Week 52: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-0.2|-4.5|= 0.0313
72485067|NCT03627767|144497484|SUPERIORITY||LSM difference|-5.1|||<|0.0001|TWO_SIDED|95.0|-7.1|-3.0|||Mixed Models Analysis|||Week 52: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-3.0|-7.1|< 0.0001
72485068|NCT03627767|144497484|SUPERIORITY||LSM difference|-2.7|||||TWO_SIDED|95.0|-4.1|-1.3||||||Week 52: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-1.3|-4.1|
72485069|NCT03627767|144497485|SUPERIORITY||LSM difference|-0.1|||=|0.4832|TWO_SIDED|95.0|-0.4|0.2|||Mixed Models Analysis|||Week 12: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||0.2|-0.4|= 0.4832
72485070|NCT03627767|144497485|SUPERIORITY||LSM difference|-0.1|||=|0.6553|TWO_SIDED|95.0|-0.3|0.2|||Mixed Models Analysis|||Week 12: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||0.2|-0.3|= 0.6553
72485071|NCT03627767|144497485|SUPERIORITY||LSM difference|0.0|||||TWO_SIDED|95.0|-0.2|0.3||||||Week 12: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||0.3|-0.2|
72512347|NCT03364335|144554721|OTHER|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline HbA1c as the covariate. Treatment A is used as the reference group.||||||0.0608|||||||ANCOVA|||||||0.0608
72512348|NCT03364335|144554721|OTHER|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline HbA1c as the covariate. Treatment A is used as the reference group.||||||0.1583|||||||ANCOVA|||||||0.1583
72485072|NCT03627767|144497485|SUPERIORITY||LSM difference|-1.3|||<|0.0001|TWO_SIDED|95.0|-1.5|-1.1|||Mixed Models Analysis|||Week 16: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-1.1|-1.5|< 0.0001
72485073|NCT03627767|144497485|SUPERIORITY||LSM difference|-2.0|||<|0.0001|TWO_SIDED|95.0|-2.2|-1.7|||Mixed Models Analysis|||Week 16: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-1.7|-2.2|< 0.0001
72512349|NCT03364335|144554722|OTHER|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline diastolic blood pressure as the covariate. Treatment A is used as the reference group.||||||0.0524|||||||ANCOVA|||||||0.0524
72576900|NCT00261443|144680710|SUPERIORITY_OR_OTHER_LEGACY|||||||0.206||95.0|||||Wilcoxon Rank Sum Test|||Lowest Value Treatment Comparison; Aripiprazole/Placebo||||0.206
72485074|NCT03627767|144497485|SUPERIORITY||LSM difference|-0.7|||||TWO_SIDED|95.0|-0.9|-0.4||||||Week 16: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-0.4|-0.9|
72485075|NCT03627767|144497485|SUPERIORITY||LSM difference|-1.3|||<|0.0001|TWO_SIDED|95.0|-1.7|-1.0|||Mixed Models Analysis|||Week 28: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-1.0|-1.7|< 0.0001
72485076|NCT03627767|144497485|SUPERIORITY||LSM difference|-2.2|||<|0.0001|TWO_SIDED|95.0|-2.5|-1.8|||Mixed Models Analysis|||Week 28: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-1.8|-2.5|< 0.0001
72485077|NCT03627767|144497485|SUPERIORITY||LSM difference|-0.8|||||TWO_SIDED|95.0|-1.1|-0.5||||||Week 28: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-0.5|-1.1|
72485078|NCT03627767|144497485|SUPERIORITY||LSM difference|-1.0|||<|0.0001|TWO_SIDED|95.0|-1.4|-0.6|||Mixed Models Analysis|||Week 40: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-0.6|-1.4|< 0.0001
72485079|NCT03627767|144497485|SUPERIORITY||LSM difference|-1.8|||<|0.0001|TWO_SIDED|95.0|-2.2|-1.4|||Mixed Models Analysis|||Week 40: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-1.4|-2.2|< 0.0001
72485080|NCT03627767|144497485|SUPERIORITY||LSM difference|-0.8|||||TWO_SIDED|95.0|-1.1|-0.5||||||Week 40: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-0.5|-1.1|
72512350|NCT03364335|144554722|OTHER|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline diastolic blood pressure as the covariate. Treatment A is used as the reference group.||||||0.5221|||||||ANCOVA|||||||0.5221
72512351|NCT03364335|144554722|OTHER|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline diastolic blood pressure as the covariate. Treatment A is used as the reference group.||||||0.3702|||||||ANCOVA|||||||0.3702
72512352|NCT03364335|144554722|OTHER|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline diastolic blood pressure as the covariate. Treatment A is used as the reference group.||||||0.5426|||||||ANCOVA|||||||0.5426
72512353|NCT03364335|144554723|OTHER|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline systolic blood pressure as the covariate. Treatment A is used as the reference group.||||||0.1843|||||||ANCOVA|||||||0.1843
72512354|NCT03364335|144554723|OTHER|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline systolic blood pressure as the covariate. Treatment A is used as the reference group.||||||0.4411|||||||ANCOVA|||||||0.4411
72512355|NCT03364335|144554723|OTHER|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline systolic blood pressure as the covariate. Treatment A is used as the reference group.||||||0.6991|||||||ANCOVA|||||||0.6991
72512356|NCT03364335|144554723|OTHER|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline systolic blood pressure as the covariate. Treatment A is used as the reference group.||||||0.3721|||||||ANCOVA|||||||0.3721
72512357|NCT03364335|144554724|OTHER|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline hsCRP as the covariate. Treatment A is used as the reference group.||||||0.0318|||||||ANCOVA|||||||0.0318
72512358|NCT03364335|144554724|OTHER|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline hsCRP as the covariate. Treatment A is used as the reference group.||||||0.3827|||||||ANCOVA|||||||0.3827
72512359|NCT03364335|144554724|OTHER|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline hsCRP as the covariate. Treatment A is used as the reference group.||||||0.005|||||||ANCOVA|||||||0.0050
72512360|NCT03364335|144554724|OTHER|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline hsCRP as the covariate. Treatment A is used as the reference group.||||||0.1045|||||||ANCOVA|||||||0.1045
72512361|NCT02670915|144554725|NON_INFERIORITY|Stepwise hierarchical testing procedure was applied: Step 1-Primary analysis: HbA1c non-inferiority of mealtime faster aspart versus mealtime NovoRapid®/NovoLog® both in combination with insulin degludec. Non-inferiority of mealtime faster aspart was considered confirmed if the upper boundary of the two-sided 95% confidence interval (CI) was below or equal to 0.4%.|Treatment difference|-0.17|||<|0.001|TWO_SIDED|95.0|-0.3|-0.03||p-values are from the 1-sided test for non-inferiority evaluated at the 2.5% level.|Multiple imputation|Analyses were adjusted for region, strata (age), as factors, and baseline HbA1c as a covariate.||The primary analysis was implemented as a statistical model using multiple imputation where the participants without any available HbA1c measurements at scheduled visits had their change from baseline HbA1c value (s) imputed from the available information from the treatment the participant had been randomised to.||-0.03|-0.30|<0.001
72576901|NCT00261443|144680711|SUPERIORITY_OR_OTHER_LEGACY|||||||0.142||95.0|||||Wilcoxon Rank Sum Test|||Baseline Treatment Comparison; Aripiprazole/Placebo||||0.142
72485081|NCT03627767|144497485|SUPERIORITY||LSM difference|-0.8|||=|0.002|TWO_SIDED|95.0|-1.2|-0.3|||Mixed Models Analysis|||Week 52: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-0.3|-1.2|= 0.0020
72576902|NCT00261443|144680711|SUPERIORITY_OR_OTHER_LEGACY|||||||0.11||95.0|||||Wilcoxon Rank Sum Test|||Week 52 LOCF Treatment Comparison; Aripiprazole/Placebo||||0.110
72512362|NCT02670915|144554725|NON_INFERIORITY|Stepwise hierarchical testing procedure was applied: Step 2-Confirmatory secondary analysis: HbA1c non-inferiority of postmeal faster aspart versus mealtime NovoRapid®/NovoLog® both in combination with insulin degludec. Non-inferiority of mealtime faster aspart was considered confirmed if the upper boundary of the two-sided 95% CI was below or equal to 0.4%.|Treatment difference|0.13|||<|0.001|TWO_SIDED|95.0|-0.01|0.26||p-values are from the 1-sided test for non-inferiority evaluated at the 2.5% level.|Multiple imputation|Analyses were adjusted for region, strata (age), as factors, and baseline HbA1c as a covariate.||The analysis was implemented as a statistical model using multiple imputation where the participants without any available HbA1c measurements at scheduled visits had their change from baseline HbA1c value(s) imputed from the available information from the treatment the participant had been randomised to.||0.26|-0.01|<0.001
72512363|NCT02670915|144554725|SUPERIORITY|Stepwise hierarchical testing procedure was applied: Step 3-Confirmatory secondary analysis: HbA1c superiority of mealtime faster aspart versus mealtime NovoRapid®/NovoLog® both in combination with insulin degludec. Superiority of mealtime faster aspart was considered confirmed if the upper boundary of the two-sided 95% CI was below 0.|Treatment difference|-0.17|||=|0.007|TWO_SIDED|95.0|-0.3|-0.03||p-values are from the 1-sided test for superiority evaluated at the 2.5% level.|multiple imputation|Analyses were adjusted for region, strata (age), as factors, and baseline HbA1c as a covariate.||The analysis was implemented as a statistical model using multiple imputation where the participants without any available HbA1c measurements at scheduled visits had their change from baseline HbA1c value(s) imputed from the available information from the treatment the participant had been randomised to.||-0.03|-0.30|=0.007
72512364|NCT00818207|144554805|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.64||||0.0007|TWO_SIDED|95.0|1.23|2.18|||Regression, Logistic|||Odds ratios and p-values were obtained from a logistic regression model including the main effects of intervention and pooled center.||2.18|1.23|0.0007
72512365|NCT00818207|144554806|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.68||||0.0018|TWO_SIDED|95.0|1.21|2.33|||Regression, Logistic|||Odds ratios and p-values were obtained from a logistic regression model including the main effects of intervention and pooled center.||2.33|1.21|0.0018
72512366|NCT00818207|144554807|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.25||||0.2979|TWO_SIDED|95.0|0.82|1.9||p-value was not adjusted for multiple comparisons.|Regression, Logistic|||Week 39 odds ratios and p-values were obtained from a logistic regression model including the main effects of intervention and pooled center.||1.90|0.82|0.2979
72402562|NCT01480076|144311685|SUPERIORITY_OR_OTHER|||||||0.3852|||||||mixed effect model|||Month 9, PRMS. Mixed effect model for repeated measures with visit, baseline of percentage of overall work impairment due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.3852
72402563|NCT01480076|144311685|SUPERIORITY_OR_OTHER|||||||0.0652|||||||mixed effect model|||Month 12, RRMS. Mixed effect model for repeated measures with visit, baseline of percentage of overall work impairment due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.0652
72402564|NCT01480076|144311685|SUPERIORITY_OR_OTHER|||||||0.5719|||||||mixed effect model|||Month 12, SPMS. Mixed effect model for repeated measures with visit, baseline of percentage of overall work impairment due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.5719
72402565|NCT01480076|144311685|SUPERIORITY_OR_OTHER|||||||0.9237|||||||mixed effect model|||Month 12, PPMS. Mixed effect model for repeated measures with visit, baseline of percentage of overall work impairment due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.9237
72402566|NCT01480076|144311685|SUPERIORITY_OR_OTHER|||||||0.131|||||||mixed effect model|||Month 12, PRMS. Mixed effect model for repeated measures with visit, baseline of percentage of overall work impairment due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.1310
72402567|NCT01480076|144311686|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Overall, RRMS. Mixed effect model for repeated measures with visit, baseline of percentage of regular activity productivity loss, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
72402568|NCT01480076|144311686|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Overall, SPMS. Mixed effect model for repeated measures with visit, baseline of percentage of regular activity productivity loss, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
72402569|NCT01480076|144311686|SUPERIORITY_OR_OTHER|||||||0.0001|||||||mixed effect model|||Overall, PPMS. Mixed effect model for repeated measures with visit, baseline of percentage of regular activity productivity loss, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.0001
72402570|NCT01480076|144311686|SUPERIORITY_OR_OTHER|||||||0.0003|||||||mixed effect model|||Overall, PRMS. Mixed effect model for repeated measures with visit, baseline of percentage of regular activity productivity loss, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.0003
72512367|NCT00818207|144554807|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.19||||0.4388|TWO_SIDED|95.0|0.76|1.87||p-value was not adjusted for multiple comparisons.|Regression, Logistic|||Week 52 odds ratios and p-values were obtained from a logistic regression model including the main effects of intervention and pooled center.||1.87|0.76|0.4388
72576903|NCT00261443|144680711|SUPERIORITY_OR_OTHER_LEGACY|||||||0.022||95.0|||||Wilcoxon Rank Sum Test|||Highest Value Treatment Comparison; Aripiprazole/Placebo||||0.022
72567541|NCT03431974|144666254|SUPERIORITY|||||||0.43|||||||Fisher Exact|||The efficacy of LD-AMT established using a step-down analysis approach with one-sided Fisher's exact tests. First, the analysis for subjects attaining PASI 75 will be performed, then, if that analysis shows a significant treatment effect, analysis for subjects attaining a sPGA success will be performed.||||0.43
72485082|NCT03627767|144497485|SUPERIORITY||LSM difference|-1.7|||<|0.0001|TWO_SIDED|95.0|-2.2|-1.2|||Mixed Models Analysis|||Week 52: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-1.2|-2.2|< 0.0001
72567542|NCT03864042|144666275|OTHER||Geometric LS Mean Ratio|1.17|||||TWO_SIDED|90.0|0.978|1.4|||||Day 1 / Day -7|||1.40|0.978|
72485083|NCT03627767|144497485|SUPERIORITY||LSM difference|-0.9|||||TWO_SIDED|95.0|-1.3|-0.6||||||Week 52: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-0.6|-1.3|
72567543|NCT03864042|144666275|OTHER||Geometric LS Mean Ratio|0.258|||||TWO_SIDED|90.0|0.215|0.308|||||Day 14 / Day -7|||0.308|0.215|
72567544|NCT03864042|144666276|OTHER||Geometric LS Mean Ratio|1.12|||||TWO_SIDED|90.0|0.998|1.25|||||Day 1 / Day -7|||1.25|0.998|
72567545|NCT03864042|144666276|OTHER||Geometric LS Mean Ratio|1.25|||||TWO_SIDED|90.0|1.12|1.4|||||Day 14 / Day -7|||1.40|1.12|
72567546|NCT03864042|144666277|OTHER||Geometric LS Mean Ratio|1.34|||||TWO_SIDED|90.0|1.12|1.62|||||Day 1 / Day -7|||1.62|1.12|
72402571|NCT01480076|144311686|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 3, RRMS. Mixed effect model for repeated measures with visit, baseline of percentage of regular activity productivity loss, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
72512368|NCT00818207|144554808|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.72|||<|0.0001|TWO_SIDED|95.0|1.35|2.2||p-value was not adjusted for multiple comparisons.|Regression, Logistic|||Odds ratios and p-values were obtained from a logistic regression model including the main effects of intervention and pooled center.||2.20|1.35|<0.0001
72512369|NCT00818207|144554809|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.14||||0.4551|TWO_SIDED|95.0|0.81|1.62||p-value was not adjusted for multiple comparisons.|Regression, Logistic|||Week 52 odds ratios and p-values were obtained from a logistic regression model including the main effects of intervention and pooled center.||1.62|0.81|0.4551
72567547|NCT03864042|144666277|OTHER||Geometric LS Mean Ratio|0.622|||||TWO_SIDED|90.0|0.517|0.748|||||Day 14 / Day -7|||0.748|0.517|
72485084|NCT03034460|144497494|SUPERIORITY||||||=|0.158|||||||Wilcoxon rank signed test|||This analysis was performed in participants applied CD5024 1% Cream on one side of face and CD5024 1% Cream Matched Placebo on other side of face for paired difference between Active - Vehicle (CD5024 1% Cream \[n=48\] versus CD5024 1% Cream Matched Placebo \[n=48\]).||||= 0.158
72512370|NCT02320695|144554878|NON_INFERIORITY_OR_EQUIVALENCE|"For the purpose of showing equivalent stinging of investigational product to saline, the hypothesis was set up as: Ho: μ1 - μ2 ≥ D vs HA: μ1 - μ2 \< D where D was the non-inferiority margin. Equivalent stinging of investigational product to saline was claimed if the upper limit of the two-sided 95% confidence interval of (investigational product - saline) was less than 0.5."|Mean Difference (Net)|-0.12|STANDARD_ERROR_OF_MEAN|0.12||0.187|TWO_SIDED|95.0|-0.33|0.05|||ANCOVA|Terms included treatment as factor, post tape-stripping score as covariate and subject as random effect to incorporate within-subject correlations.||||0.05|-0.33|0.187
72567548|NCT03864042|144666278|OTHER||Geometric LS Mean Ratio|1.09|||||TWO_SIDED|90.0|0.975|1.23|||||Day 1 / Day -7|||1.23|0.975|
72567549|NCT03864042|144666278|OTHER||Geometric LS Mean Ratio|1.3|||||TWO_SIDED|90.0|1.16|1.46|||||Day 14 / Day -7|||1.46|1.16|
72567550|NCT03864042|144666279|OTHER||Geometric LS Mean Ratio|1.05|||||TWO_SIDED|90.0|0.922|1.2|||||Day 1 / Day -7|||1.20|0.922|
72567551|NCT03864042|144666279|OTHER||Geometric LS Mean Ratio|1.13|||||TWO_SIDED|90.0|0.992|1.29|||||Day 14 / Day -7|||1.29|0.992|
72567552|NCT03864042|144666280|OTHER||Geometric LS Mean Ratio|1.09|||||TWO_SIDED|90.0|0.99|1.19|||||Day 1 / Day -7|||1.19|0.990|
72567553|NCT03864042|144666280|OTHER||Geometric LS Mean Ratio|1.1|||||TWO_SIDED|90.0|1.0|1.22|||||Day 14 / Day -7|||1.22|1.00|
72567554|NCT03864042|144666281|OTHER||Geometric LS Mean Ratio|0.894|||||TWO_SIDED|90.0|0.741|1.08|||||Day 1 / Day -7|||1.08|0.741|
72567555|NCT03864042|144666281|OTHER||Geometric LS Mean Ratio|0.692|||||TWO_SIDED|90.0|0.573|0.835|||||Day 14 / Day -7|||0.835|0.573|
72567556|NCT03864042|144666282|OTHER||Geometric LS Mean Ratio|1.32|||||TWO_SIDED|90.0|0.861|2.04|||||Day 1 / Day -7|||2.04|0.861|
72567557|NCT03864042|144666282|OTHER||Geometric LS Mean Ratio|1.01|||||TWO_SIDED|90.0|0.659|1.56|||||Day 14 / Day -7|||1.56|0.659|
72567558|NCT03864042|144666283|OTHER||Geometric LS Mean Ratio|1.01|||||TWO_SIDED|90.0|0.762|1.33|||||Day 1 / Day -7|||1.33|0.762|
72567559|NCT03864042|144666283|OTHER||Geometric LS Mean Ratio|0.718|||||TWO_SIDED|90.0|0.543|0.948|||||Day 14 / Day -7|||0.948|0.543|
72567560|NCT03864042|144666284|OTHER||Geometric LS Mean Ratio|4.34|||||TWO_SIDED|90.0|2.94|6.4|||||Day 1 / Day -7|||6.40|2.94|
72567561|NCT03864042|144666284|OTHER||Geometric LS Mean Ratio|2.68|||||TWO_SIDED|90.0|1.82|3.96|||||Day 14 / Day -7|||3.96|1.82|
72567562|NCT03864042|144666285|OTHER||Geometric LS Mean Ratio|0.754|||||TWO_SIDED|90.0|0.595|0.954|||||Day 1 / Day -7|||0.954|0.595|
72567563|NCT03864042|144666285|OTHER||Geometric LS Mean Ratio|0.755|||||TWO_SIDED|90.0|0.596|0.957|||||Day 14 / Day -7|||0.957|0.596|
72567564|NCT03864042|144666286|OTHER||Geometric LS Mean Ratio|1.05|||||TWO_SIDED|90.0|0.864|1.27|||||Day 1 / Day -7|||1.27|0.864|
72567565|NCT03864042|144666286|OTHER||Geometric LS Mean Ratio|1.42|||||TWO_SIDED|90.0|1.17|1.72|||||Day 14 / Day -7|||1.72|1.17|
72567566|NCT03864042|144666287|OTHER||Geometric LS Mean Ratio|1.07|||||TWO_SIDED|90.0|0.92|1.25|||||Day 1 / Day -7|||1.25|0.920|
72567567|NCT03864042|144666287|OTHER||Geometric LS Mean Ratio|0.175|||||TWO_SIDED|90.0|0.151|0.204|||||Day 14 / Day -7|||0.204|0.151|
72567568|NCT03864042|144666288|OTHER||Geometric LS Mean Ratio|1.28|||||TWO_SIDED|90.0|1.18|1.38|||||Day 1 / Day -7|||1.38|1.18|
72567569|NCT03864042|144666288|OTHER||Geometric LS Mean Ratio|1.05|||||TWO_SIDED|90.0|0.974|1.14|||||Day 14 / Day -7|||1.14|0.974|
72512371|NCT02320695|144554878|NON_INFERIORITY_OR_EQUIVALENCE|"For the purpose of showing equivalent stinging of investigational product to saline, the hypothesis was set up as: Ho: μ1 - μ2 ≥ D vs HA: μ1 - μ2 \< D where D was the non-inferiority margin. Equivalent stinging of investigational product to saline was claimed if the upper limit of the two-sided 95% confidence interval of (investigational product - saline) was less than 0.5."|Mean Difference (Net)|-0.2|STANDARD_ERROR_OF_MEAN|0.12||0.101|TWO_SIDED|95.0|-0.42|0.04|||ANCOVA|Terms included treatment as factor, post tape-stripping score as covariate and subject as random effect to incorporate within-subject correlations.||||0.04|-0.42|0.101
72485085|NCT03034460|144497494|SUPERIORITY||||||=|0.002|||||||Wilcoxon rank signed test|||This analysis was performed in participants applied Adapalene Benzoyl Peroxyde on one side of face and Adapalene Benzoyl Peroxyde Matched Placebo on the other side of face for paired difference between Active - Vehicle (Adapalene Benzoyl Peroxyde \[n=22\] versus Adapalene Benzoyl Peroxyde Matched Placebo \[n=22\]).||||= 0.002
72512372|NCT02320695|144554878|NON_INFERIORITY_OR_EQUIVALENCE|"For the purpose of showing equivalent stinging of investigational product to saline, the hypothesis was set up as: Ho: μ1 - μ2 ≥ D vs HA: μ1 - μ2 \< D where D was the non-inferiority margin. Equivalent stinging of investigational product to saline was claimed if the upper limit of the two-sided 95% confidence interval of (investigational product - saline) was less than 0.5."|Mean Difference (Net)|-0.28|STANDARD_ERROR_OF_MEAN|0.12||0.002|TWO_SIDED|95.0|-0.49|-0.1|||ANCOVA|Terms included treatment as factor, post tape-stripping score as covariate and subject as random effect to incorporate within-subject correlations.||||-0.10|-0.49|0.002
72512373|NCT02320695|144554878|NON_INFERIORITY_OR_EQUIVALENCE|"For the purpose of showing equivalent stinging of investigational product to saline, the hypothesis was set up as: Ho: μ1 - μ2 ≥ D vs HA: μ1 - μ2 \< D where D was the non-inferiority margin. Equivalent stinging of investigational product to saline was claimed if the upper limit of the two-sided 95% confidence interval of (investigational product - saline) was less than 0.5."|Mean Difference (Net)|-0.31|STANDARD_ERROR_OF_MEAN|0.12|<|0.001|TWO_SIDED|95.0|-0.53|-0.12|||ANCOVA|Terms included treatment as factor, post tape-stripping score as covariate and subject as random effect to incorporate within-subject correlations.||||-0.12|-0.53|<0.001
72512374|NCT02320695|144554879|NON_INFERIORITY_OR_EQUIVALENCE|"For the purpose of showing equivalent stinging of investigational product to saline, the hypothesis was set up as: Ho: μ1 - μ2 ≥ D vs HA: μ1 - μ2 \< D where D was the non-inferiority margin. Equivalent stinging of investigational product to saline was claimed if the upper limit of the two-sided 95% confidence interval of (investigational product - saline) was less than 0.5."|Mean Difference (Net)|-0.29|STANDARD_ERROR_OF_MEAN|0.12||0.023|TWO_SIDED|95.0|-0.54|-0.05|||ANCOVA|Terms included treatment as factor, post tape-stripping score as covariate and subject as random effect to incorporate within-subject correlations.||||-0.05|-0.54|0.023
72402572|NCT01480076|144311686|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 3, SPMS. Mixed effect model for repeated measures with visit, baseline of percentage of regular activity productivity loss, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
72485086|NCT01798992|144497509|SUPERIORITY_OR_OTHER_LEGACY|||||||0.685|TWO_SIDED||||||Fisher Exact|||The null hypothesis is that there is no difference in rate of LVEF improvement according to treatment group.||||0.685
72485087|NCT01798992|144497510|SUPERIORITY_OR_OTHER_LEGACY|||||||0.071|TWO_SIDED||||||Fisher Exact|||The null hypothesis is that there is no difference in rate of LVEF improvement according to treatment group.||||0.071
72485088|NCT00763971|144497516|SUPERIORITY_OR_OTHER_LEGACY||difference in LS means|-18.6|||<|0.001|TWO_SIDED|95.0|-21.5|-15.7|||ANCOVA|||||-15.7|-21.5|<0.001
72485089|NCT00763971|144497516|SUPERIORITY_OR_OTHER_LEGACY||difference in LS means|-13.0|||<|0.001|TWO_SIDED|95.0|-15.9|-10.2|||ANCOVA|||||-10.2|-15.9|<0.001
72485090|NCT00763971|144497517|SUPERIORITY_OR_OTHER_LEGACY||difference in percentages|63.6|||<|0.001|TWO_SIDED|95.0|53.0|74.1|||Cochran-Mantel-Haenszel|||||74.1|53.0|<0.001
72485091|NCT00763971|144497517|SUPERIORITY_OR_OTHER_LEGACY||difference in percentages|46.2|||<|0.001|TWO_SIDED|95.0|34.6|57.7|||Cochran-Mantel-Haenszel|||||57.7|34.6|<0.001
72485092|NCT00763971|144497518|SUPERIORITY_OR_OTHER_LEGACY||difference in LS means|-21.3|||<|0.001|TWO_SIDED|95.0|-25.5|-17.0|||ANCOVA|||||-17.0|-25.5|<0.001
72567570|NCT03864042|144666289|OTHER||Geometric LS Mean Ratio|1.25|||||TWO_SIDED|90.0|1.09|1.43|||||Day 1 / Day -7|||1.43|1.09|
72567571|NCT03864042|144666289|OTHER||Geometric LS Mean Ratio|0.513|||||TWO_SIDED|90.0|0.449|0.587|||||Day 14 / Day -7|||0.587|0.449|
72567572|NCT03864042|144666290|OTHER||Geometric LS Mean Ratio|1.28|||||TWO_SIDED|90.0|1.17|1.39|||||Day 1 / Day -7|||1.39|1.17|
72485093|NCT00763971|144497518|SUPERIORITY_OR_OTHER_LEGACY||difference in LS means|-15.1|||<|0.001|TWO_SIDED|95.0|-19.3|-10.9|||ANCOVA|||||-10.9|-19.3|<0.001
72485094|NCT00763971|144497520|SUPERIORITY_OR_OTHER_LEGACY||difference in LS means|8.8|||<|0.001|TWO_SIDED|95.0|6.1|11.5|||ANCOVA|||||11.5|6.1|<0.001
72485095|NCT00763971|144497520|SUPERIORITY_OR_OTHER_LEGACY||difference in LS means|7.3|||<|0.001|TWO_SIDED|95.0|4.6|10.0|||ANCOVA|||||10.0|4.6|<0.001
72485096|NCT00763971|144497521|SUPERIORITY_OR_OTHER_LEGACY||difference in LS means|-0.3|||<|0.001|TWO_SIDED|95.0|-0.4|-0.2|||ANCOVA|||||-0.2|-0.4|<0.001
72485097|NCT00763971|144497521|SUPERIORITY_OR_OTHER_LEGACY||difference in LS means|-0.2|||<|0.001|TWO_SIDED|95.0|-0.3|-0.1|||ANCOVA|||||-0.1|-0.3|<0.001
72485098|NCT04439071|144497533|OTHER|||||||0.949|||||||Log Rank|||Time to respiratory improvement was compared between treatment groups using stratified log-rank test.||||0.949
72485099|NCT04439071|144497552|OTHER|||||||0.033|||||||Log Rank|||Time to respiratory improvement was compared between treatment groups using stratified log-rank test.||||0.033
72485100|NCT01936909|144497654|SUPERIORITY||||||>|0.2|||||||ANOVA|||This test reflects a comparison between baseline and 2 weeks (both rows).||||>0.20
72485101|NCT01936909|144497655|SUPERIORITY||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||Paired analysis versus baseline||||<0.01
72485102|NCT01936909|144497656|SUPERIORITY|Log-rank test||||||0.12|||||||Log Rank|||||||0.12
72485103|NCT01958788|144497657|SUPERIORITY_OR_OTHER||Cohen's d effect size|2.06|||||TWO_SIDED||||||Cohen's d effect size|||Pre-posttreatment effect size estimation using Cohen's d: a calculation of the relative magnitude of the effect from pretreatment to posttreatment||||
72567573|NCT03864042|144666290|OTHER||Geometric LS Mean Ratio|1.07|||||TWO_SIDED|90.0|0.979|1.16|||||Day 14 / Day -7|||1.16|0.979|
72567574|NCT03864042|144666291|OTHER||Geometric LS Mean Ratio|1.09|||||TWO_SIDED|90.0|0.947|1.26|||||Day 1 / Day -7|||1.26|0.947|
72512375|NCT02320695|144554879|NON_INFERIORITY_OR_EQUIVALENCE|"For the purpose of showing equivalent stinging of investigational product to saline, the hypothesis was set up as: Ho: μ1 - μ2 ≥ D vs HA: μ1 - μ2 \< D where D was the non-inferiority margin. Equivalent stinging of investigational product to saline was claimed if the upper limit of the two-sided 95% confidence interval of (investigational product - saline) was less than 0.5."|Mean Difference (Net)|-0.08|STANDARD_ERROR_OF_MEAN|0.12||0.522|TWO_SIDED|95.0|-0.32|0.2|||ANCOVA|Terms included treatment as factor, post tape-stripping score as covariate and subject as random effect to incorporate within-subject correlations.||||0.20|-0.32|0.522
72512376|NCT02320695|144554879|NON_INFERIORITY_OR_EQUIVALENCE|"For the purpose of showing equivalent stinging of investigational product to saline, the hypothesis was set up as: Ho: μ1 - μ2 ≥ D vs HA: μ1 - μ2 \< D where D was the non-inferiority margin. Equivalent stinging of investigational product to saline was claimed if the upper limit of the two-sided 95% confidence interval of (investigational product - saline) was less than 0.5."|Mean Difference (Net)|-0.37|STANDARD_ERROR_OF_MEAN|0.12|<|0.001|TWO_SIDED|95.0|-0.67|-0.16|||ANCOVA|Terms included treatment as factor, post tape-stripping score as covariate and subject as random effect to incorporate within-subject correlations.||||-0.16|-0.67|<0.001
72512377|NCT02320695|144554879|NON_INFERIORITY_OR_EQUIVALENCE|"For the purpose of showing equivalent stinging of investigational product to saline, the hypothesis was set up as: Ho: μ1 - μ2 ≥ D vs HA: μ1 - μ2 \< D where D was the non-inferiority margin. Equivalent stinging of investigational product to saline was claimed if the upper limit of the two-sided 95% confidence interval of (investigational product - saline) was less than 0.5."|Mean Difference (Net)|-0.34|STANDARD_ERROR_OF_MEAN|0.12||0.013|TWO_SIDED|95.0|-0.63|-0.07|||ANCOVA|Terms included treatment as factor, post tape-stripping score as covariate and subject as random effect to incorporate within-subject correlations.||||-0.07|-0.63|0.013
72485104|NCT01958788|144497657|SUPERIORITY_OR_OTHER||Cohen's d effect size|1.34|||||TWO_SIDED||||||Cohen's d effect size|||Pretreatment to 6-month follow-up effect size estimation using Cohen's d: a calculation of the relative magnitude of the effect from pretreatment to 6-month follow-up||||
72485105|NCT01958788|144497657|SUPERIORITY_OR_OTHER||Cohen's d effect size|0.37|||||TWO_SIDED||||||Cohen's d effect size|||Posttreatment to 6-month follow-up effect size estimation using Cohen's d: a calculation of the relative magnitude of the effect from posttreatment to 6-month follow-up||||
72485106|NCT01958788|144497658|SUPERIORITY_OR_OTHER||Cohen's d effect size|1.32|||||TWO_SIDED||||||Cohen's d effect size|||Pre-posttreatment effect size estimation using Cohen's d: a calculation of the relative magnitude of the effect from pretreatment to posttreatment||||
72485107|NCT01958788|144497658|SUPERIORITY_OR_OTHER||Cohen's d effect size|1.29|||||TWO_SIDED||||||Cohen's d effect size|||Pretreatment to 6-month follow-up effect size estimation using Cohen's d: a calculation of the relative magnitude of the effect from pretreatment to 6-month follow-up||||
72485108|NCT01958788|144497658|SUPERIORITY_OR_OTHER||Cohen's d effect size|-0.15|||||TWO_SIDED||||||Cohen's d effect size|||Posttreatment to 6-month follow-up effect size estimation using Cohen's d: a calculation of the relative magnitude of the effect from posttreatment to 6-month follow-up||||
72485109|NCT01958788|144497659|SUPERIORITY_OR_OTHER||Cohen's d effect size|1.72|||||TWO_SIDED||||||Cohen's d effect size|||Pre-posttreatment follow-up effect size estimation using Cohen's d: a calculation of the relative magnitude of the effect from pretreatment to posttreatment follow-up||||
72512378|NCT01670656|144554882|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Means|-0.6|||<|0.001|TWO_SIDED|95.0|-1.0|-0.2|||cLDA|||||-0.2|-1.0|< 0.001
72485110|NCT01958788|144497659|SUPERIORITY_OR_OTHER||Cohen's d effect size|1.66|||||TWO_SIDED||||||Cohen's d effect size|||Pretreatment to 6-month follow-up effect size estimation using Cohen's d: a calculation of the relative magnitude of the effect from pretreatment to 6-month follow-up||||
72485111|NCT01958788|144497659|SUPERIORITY_OR_OTHER||Cohen's d effect size|0.07|||||TWO_SIDED||||||Cohen's d effect size|||Posttreatment to 6-month follow-up effect size estimation using Cohen's d: a calculation of the relative magnitude of the effect from posttreatment to 6-month follow-up||||
72512379|NCT01670656|144554882|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Means|-0.6|||<|0.001|TWO_SIDED|95.0|-0.9|-0.2|||cLDA|||||-0.2|-0.9|< 0.001
72512380|NCT01670656|144554882|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Means|-0.8|||<|0.001|TWO_SIDED|95.0|-1.1|-0.4|||cLDA|||||-0.4|-1.1|< 0.001
72512381|NCT01670656|144554882|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Means|-0.5|||<|0.001|TWO_SIDED|95.0|-0.9|-0.2|||cLDA|||||-0.2|-0.9|< 0.001
72485112|NCT01958788|144497660|SUPERIORITY_OR_OTHER||Cohen's d effect size|1.13|||||TWO_SIDED||||||Cohen's d effect size|||Pre-posttreatment effect size estimation using Cohen's d: a calculation of the relative magnitude of the effect from pretreatment to posttreatment||||
72485113|NCT01958788|144497660|SUPERIORITY_OR_OTHER||Cohen's d effect size|1.06|||||TWO_SIDED||||||Cohen's d effect size|||Pretreatment to 6-month follow-up effect size estimation using Cohen's d: a calculation of the relative magnitude of the effect from pretreatment to 6-month follow-up||||
72485114|NCT01958788|144497660|SUPERIORITY_OR_OTHER||Cohen's d effect size|-0.18|||||TWO_SIDED||||||Cohen's d effect size|||Posttreatment to 6-month follow-up effect size estimation using Cohen's d: a calculation of the relative magnitude of the effect from posttreatment to 6-month follow-up||||
72485115|NCT01958788|144497661|SUPERIORITY_OR_OTHER||Cohen's d effect size|1.41|||||TWO_SIDED||||||Cohen's d effect size|||Pre-posttreatment effect size estimation using Cohen's d: a calculation of the relative magnitude of the effect from pretreatment to posttreatment||||
72485116|NCT01958788|144497661|SUPERIORITY_OR_OTHER||Cohen's d effect size|1.65|||||TWO_SIDED||||||Cohen's d effect size|||Pretreatment to 6-month follow-up effect size estimation using Cohen's d: a calculation of the relative magnitude of the effect from pretreatment to 6-month follow-up||||
72512382|NCT01670656|144554883|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Means|-1.7|||=|0.002|TWO_SIDED|95.0|-3.0|-0.4|||cLDA|||||-0.4|-3.0|= 0.002
72512383|NCT01670656|144554883|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Means|-1.9|||<|0.001|TWO_SIDED|95.0|-3.1|-0.6|||cLDA|||||-0.6|-3.1|< 0.001
72512384|NCT01670656|144554883|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Means|-1.6|||=|0.003|TWO_SIDED|95.0|-2.9|-0.3|||cLDA|||||-0.3|-2.9|= 0.003
72567575|NCT03864042|144666291|OTHER||Geometric LS Mean Ratio|1.27|||||TWO_SIDED|90.0|1.1|1.46|||||Day 14 / Day -7|||1.46|1.10|
72567576|NCT03864042|144666292|OTHER||Geometric LS Mean Ratio|1.12|||||TWO_SIDED|90.0|1.02|1.23|||||Day 1 / Day -7|||1.23|1.02|
72567577|NCT03864042|144666292|OTHER||Geometric LS Mean Ratio|1.26|||||TWO_SIDED|90.0|1.14|1.38|||||Day 14 / Day -7|||1.38|1.14|
72485117|NCT01958788|144497661|SUPERIORITY_OR_OTHER||Cohen's d effect size|-0.7|||||TWO_SIDED||||||Cohen's d effect size|||Posttreatment to 6-month follow-up effect size estimation using Cohen's d: a calculation of the relative magnitude of the effect from posttreatment to 6-month follow-up||||
72485118|NCT01958788|144497662|SUPERIORITY_OR_OTHER||Cohen's d effect size|1.64|||||TWO_SIDED||||||Cohen's d effect size|||Pre-posttreatment effect size estimation using Cohen's d: a calculation of the relative magnitude of the effect from pretreatment to posttreatment||||
72485119|NCT01958788|144497662|SUPERIORITY_OR_OTHER||Cohen's d effect size|1.47|||||TWO_SIDED||||||Cohen's d effect size|||Pretreatment to 6-month follow-up effect size estimation using Cohen's d: a calculation of the relative magnitude of the effect from pretreatment to 6-month follow-up||||
72485120|NCT01958788|144497662|SUPERIORITY_OR_OTHER||Cohen's d effect size|-0.56|||||TWO_SIDED||||||Cohen's d effect size|||Posttreatment to 6-month follow-up effect size estimation using Cohen's d: a calculation of the relative magnitude of the effect from posttreatment to 6-month follow-up||||
72485121|NCT01958788|144497663|SUPERIORITY_OR_OTHER||Cohen's d effect size|2.08|||||TWO_SIDED||||||Cohen's d effect size|||Pre-posttreatment effect size estimation using Cohen's d: a calculation of the relative magnitude of the effect from pretreatment to posttreatment||||
72512385|NCT01670656|144554883|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Means|-1.2|||=|0.024|TWO_SIDED|95.0|-2.5|0.1|||cLDA|||||0.1|-2.5|= 0.024
72512386|NCT01670656|144554884|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Means|-1.6|||=|0.026|TWO_SIDED|95.0|-3.4|0.2|||cLDA|||||0.2|-3.4|= 0.026
72512387|NCT01670656|144554884|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Means|-1.5|||=|0.036|TWO_SIDED|95.0|-3.3|0.2|||cLDA|||||0.2|-3.3|= 0.036
72512388|NCT01670656|144554884|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Means|-2.3|||=|0.002|TWO_SIDED|95.0|-4.1|-0.5|||cLDA|||||-0.5|-4.1|= 0.002
72512389|NCT01670656|144554884|SUPERIORITY_OR_OTHER_LEGACY||Diffference in Least Squares Means|-1.2|||=|0.1|TWO_SIDED|95.0|-3.0|0.6|||cLDA|||||0.6|-3.0|= 0.1
72512390|NCT01670656|144554885|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Means|-0.1|||=|0.447|TWO_SIDED|95.0|-0.6|0.3|||cLDA|||||0.3|-0.6|= 0.447
72512391|NCT01670656|144554885|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Means|-0.6|||=|0.003|TWO_SIDED|95.0|-1.0|-0.1|||cLDA|||||-0.1|-1.0|= 0.003
72512392|NCT01670656|144554885|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Means|-0.6|||=|0.003|TWO_SIDED|95.0|-1.0|-0.1|||cLDA|||||-0.1|-1.0|= 0.003
72512393|NCT01670656|144554885|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Means|-0.3|||=|0.156|TWO_SIDED|95.0|-0.7|0.2|||cLDA|||||0.2|-0.7|= 0.156
72512394|NCT01640925|144554926|NON_INFERIORITY_OR_EQUIVALENCE|The number of patients needed to achieve 80% power was estimated at 171 using Cox proportional hazards regression (hazard ratio reduction of 0.66; 0.15 probability of infection with control) using a two-sided 5% significance.|Cox Proportional Hazard|0.555||||0.049|TWO_SIDED|95.0|0.309|0.998|||Regression, Cox||Hypothesis: Compared to soap and water daily bathing, 2% chlorhexidine gluconate bathing on ICU admission and every 48 hours during surgical ICU care will decrease the risk of acquiring four hospital-acquired infections in surgical ICU patients.|||0.998|0.309|0.049
72512395|NCT00442013|144554937|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.2|STANDARD_ERROR_OF_MEAN|0.086||0.12|TWO_SIDED|95.0|0.0|0.3|||Regression, Linear|Linear mixed effects model is robust to data that are missing at random that has characteristics similar to multiple imputation techniques.||All participants included in the analysis. The model includes the data (ACQ scores) from all time points including baseline. The treatment effect (delta-delta) comparing the difference from baseline at 6 months is estimated from the model. Longitudinal models estimated the change from baseline to 6 months in a measurement using generalized estimating equations with an unstructured or exchangeable covariance matrix to adjust for repeated measures.||0.3|0.0|0.12
72485122|NCT01958788|144497663|SUPERIORITY_OR_OTHER||Cohen's d effect size|2.15|||||TWO_SIDED||||||Cohen's d effect size|||Pretreatment to 6-month follow-up effect size estimation using Cohen's d: a calculation of the relative magnitude of the effect from pretreatment to 6-month follow-up||||
72485123|NCT01958788|144497663|SUPERIORITY_OR_OTHER||Cohen's d effect size|-0.55|||||TWO_SIDED||||||Cohen's d effect size|||Posttreatment to 6-month follow-up effect size estimation using Cohen's d: a calculation of the relative magnitude of the effect from posttreatment to 6-month follow-up||||
72485124|NCT00744211|144497664|SUPERIORITY_OR_OTHER||||||<|0.05||||||p\<0.05; Pairwise tests of individual groups means were compared by adjusted probabilities (Bonferroni method).|ANOVA|||||||<0.05
72485125|NCT00744211|144497665|SUPERIORITY_OR_OTHER|||||||0.001||||||Pairwise tests of individual groups means were compared by adjusted probabilities (Bonferroni method).|ANOVA|||||||0.001
72485126|NCT00744211|144497666|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
72512396|NCT00442013|144554938|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1|STANDARD_ERROR_OF_MEAN|0.2593||0.65|TWO_SIDED|95.0|-0.3|0.2|||Regression, Linear|||||0.2|-0.3|0.65
72512397|NCT00442013|144554939|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|0.0906||0.99|TWO_SIDED|95.0|-0.1|0.1|||Regression, Linear|||||0.1|-0.1|0.99
72512398|NCT00442013|144554940|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.2||||0.3|TWO_SIDED|95.0|0.9|1.7|||negative binomial|||||1.7|0.9|0.30
72512399|NCT00442013|144554941|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.03|STANDARD_ERROR_OF_MEAN|0.02||0.14|TWO_SIDED|95.0|-0.07|0.01|||Regression, Linear|Model includes the data from all time points. Treatment effect (delta-delta) comparing the difference from baseline at 24 weeks is from the model.||||0.01|-0.07|0.14
72512400|NCT00442013|144554942|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.8||||0.2|TWO_SIDED|95.0|-2.1|0.4|||Regression, Linear|||||0.4|-2.1|0.20
72512401|NCT01332019|144554948|SUPERIORITY_OR_OTHER||rate ratio|0.755||||0.0203|TWO_SIDED|95.0|0.595|0.957||q2w/q4w|negative binomial regression|||Based on negative binomial regression for each treatment group, with adjustment for EDSS (\<4 vs. \>=4), relapse rate (based on 1 year before 105MS301 and 105MS301), and age (\<40 vs. \>=40) at 105MS302 baseline.||0.957|0.595|0.0203
72512402|NCT01332019|144554949|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.75||||0.0201|TWO_SIDED|95.0|0.59|0.96||Based on Cox proportion hazards model, adjusted for EDSS (\<4 vs \>= 4), age (\<40 vs \>=40), relapse rate (based on one year before 105MS301 and 105MS301), and gadolinium (Gd) enhancing lesions (presence vs. absence) at 105MS302 baseline.|Cox proportion hazards model|||q2w/q4w||0.96|0.59|0.0201
72567578|NCT03864042|144666293|OTHER||Geometric LS Mean Ratio|0.9|||||TWO_SIDED|90.0|0.721|1.12|||||Day 1 / Day -7|||1.12|0.721|
72567579|NCT03864042|144666293|OTHER||Geometric LS Mean Ratio|0.679|||||TWO_SIDED|90.0|0.544|0.848|||||Day 14 / Day -7|||0.848|0.544|
72402573|NCT01480076|144311686|SUPERIORITY_OR_OTHER|||||||0.0002|||||||mixed effect model|||Month 3, PPMS. Mixed effect model for repeated measures with visit, baseline of percentage of regular activity productivity loss, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.0002
72402574|NCT01480076|144311686|SUPERIORITY_OR_OTHER|||||||0.0102|||||||mixed effect model|||Month 3, PRMS. Mixed effect model for repeated measures with visit, baseline of percentage of regular activity productivity loss, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.0102
72402575|NCT01480076|144311686|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 6, RRMS. Mixed effect model for repeated measures with visit, baseline of percentage of regular activity productivity loss, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
72402576|NCT01480076|144311686|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 6, SPMS. Mixed effect model for repeated measures with visit, baseline of percentage of regular activity productivity loss, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
72402577|NCT01480076|144311686|SUPERIORITY_OR_OTHER|||||||0.0001|||||||mixed effect model|||Month 6, PPMS. Mixed effect model for repeated measures with visit, baseline of percentage of regular activity productivity loss, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.0001
72402578|NCT01480076|144311686|SUPERIORITY_OR_OTHER|||||||0.0012|||||||mixed effect model|||Month 6, PRMS. Mixed effect model for repeated measures with visit, baseline of percentage of regular activity productivity loss, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.0012
72402579|NCT01480076|144311686|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 9, RRMS. Mixed effect model for repeated measures with visit, baseline of percentage of regular activity productivity loss, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
72402580|NCT01480076|144311686|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 9, SPMS. Mixed effect model for repeated measures with visit, baseline of percentage of regular activity productivity loss, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
72402581|NCT01480076|144311686|SUPERIORITY_OR_OTHER|||||||0.0026|||||||mixed effect model|||Month 9, SPMS. Mixed effect model for repeated measures with visit, baseline of percentage of regular activity productivity loss, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.0026
72402582|NCT01480076|144311686|SUPERIORITY_OR_OTHER|||||||0.0161|||||||mixed effect model|||Month 9, PRMS. Mixed effect model for repeated measures with visit, baseline of percentage of regular activity productivity loss, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.0161
72402583|NCT01480076|144311686|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 12, RRMS. Mixed effect model for repeated measures with visit, baseline of percentage of regular activity productivity loss, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
72402584|NCT01480076|144311686|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 12, SPMS. Mixed effect model for repeated measures with visit, baseline of percentage of regular activity productivity loss, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
72485127|NCT00744211|144497667|EQUIVALENCE|Chi-square tests for differences between groups.||||||0.015||||||P-value is associated with the hematological/lymphatic adverse event.|Chi-squared|||||||0.015
72485128|NCT01026142|144497669|SUPERIORITY||Hazard Ratio (HR)|0.82||||0.0731|TWO_SIDED|95.0|0.65|1.02||The primary endpoint, IRF-assessed PFS, is tested at a two-sided 5% significance level.|Log Rank|Two-sided and stratified by: prior CNS disease present/absent, measurable disease at baseline, and response to trastuzumab in 1L metastatic setting.|The stratified Cox proportional hazard model will be used to estimate the HR between the two treatment arms and its 95% CI.|"The null hypothesis for the primary endpoint is that the survival distributions of IRF-assessed PFS in the two treatment groups are the same. The alternative hypothesis is that the survival distributions of IRF-assessed PFS in the treatment and the control arms are different:~H0: IRF PFS\<pertuzumab\> = IRF PFS\<control\> vs. H1: IRF PFS\<pertuzumab\> ≠ IRF PFS\<control\>"||1.02|0.65|0.0731
72512403|NCT01332019|144554950|SUPERIORITY_OR_OTHER||lesion mean ratio|0.51|||<|0.0001|TWO_SIDED|95.0|0.41|0.63||Lesion mean ratio (95% CI) and p-value for comparison between the every 2 weeks group and the every 4 weeks group, based on negative binomial regression, adjusted for 105MS302 baseline number of T2 lesions.|negative binomial regression|||Week 48||0.63|0.41|<0.0001
72485129|NCT00628251|144497774|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.88||||0.6604|TWO_SIDED|95.0|0.51|1.56||If the observed p-value for the combined olaparib groups is \<0.02 (1-sided) then the result will be regarded as statistically significant.|Regression, Cox|Cox proportional hazards model with factors for treatment, BRCA (1 or 2) and platinum sensitivity (sensitive=1 or resistant/refractory=0).||Analysis of olaparib 200 or 400 mg bd (n=64) versus liposomal doxorubicin (n=33). A hazard ratio \< 1 favours olaparib.||1.56|0.51|0.6604
72402585|NCT01480076|144311686|SUPERIORITY_OR_OTHER|||||||0.1151|||||||mixed effect model|||Month 12, PPMS. Mixed effect model for repeated measures with visit, baseline of percentage of regular activity productivity loss, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.1151
72485130|NCT00628251|144497774|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.91||||0.7794||95.0|0.48|1.74||An observed p-value of \<0.005 (1-sided) will be regarded as statistically significant for a given pairwise comparison.|Regression, Cox|Cox proportional hazards model with factors for treatment, BRCA (1 or 2) and platinum sensitivity (sensitive=1 or resistant/refractory=0).||Analysis of olaparib 200 (n=32) versus liposomal doxorubicin (n=33). A hazard ratio \< 1 favours olaparib.||1.74|0.48|0.7794
72485131|NCT00628251|144497774|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.86||||0.6604|TWO_SIDED|95.0|0.45|1.62||An observed p-value of \<0.005 (1-sided) will be regarded as statistically significant for a given pairwise comparison.|Regression, Cox|Cox proportional hazards model with factors for treatment, BRCA (1 or 2) and platinum sensitivity (sensitive=1 or resistant/refractory=0).||Analysis of olaparib 400 (n=32) versus liposomal doxorubicin (n=33). A hazard ratio \< 1 favours olaparib.||1.62|0.45|0.6604
72485132|NCT00628251|144497775|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.27||||0.1291|TWO_SIDED|95.0|0.79|7.32||2-sided p-value|Regression, Logistic|Analysis was performed using logistic regression with factors for treatment, BRCA status and platinum sensitivity.|An odds ratio \>1 favoured olaparib|Analysis of olaparib 200 or 400 (n=64) versus liposomal doxorubicin (n=33).||7.32|0.79|0.1291
72485133|NCT00628251|144497775|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.9||||0.3131|TWO_SIDED|95.0|0.55|7.01||2-sided p-value|Regression, Logistic|Analysis was performed using logistic regression with factors for treatment, BRCA status and platinum sensitivity.|An odds ratio \>1 favoured olaparib.|Analysis of olaparib 200 (n=32) versus liposomal doxorubicin (n=33).||7.01|0.55|0.3131
72485134|NCT00628251|144497775|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.69||||0.1079|TWO_SIDED|95.0|0.81|9.76|||Regression, Logistic|The analysis was performed using logistic regression with factors for treatment, BRCA status and platinum sensitivity.|An odds ratio \>1 favoured olaparib|Analysis of olaparib 400 (n=32) versus liposomal doxorubicin (n=33).||9.76|0.81|0.1079
72485135|NCT00628251|144497781|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.82||||0.5781|TWO_SIDED|95.0|0.41|1.7||2-sided p-value|Regression, Cox|Analysis was performed using a Cox proportional hazards model with factors for treatment, BRCA status and platinum sensitivity.|A hazard ratio of \<1 favoured olaparib.|Analysis of olaparib 200 or 400 (n=64) versus liposomal doxorubicin (n=33).||1.70|0.41|0.5781
72485136|NCT00628251|144497781|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.66||||0.3417|TWO_SIDED|95.0|0.27|1.55||2-sided p-value|Regression, Cox|Analysis was performed using a Cox proportional hazards model with factors for treatment, BRCA status and platinum sensitivity.|A hazard ratio of \<1 favoured olaparib.|Analysis of olaparib 200 (n=32) versus liposomal doxorubicin (n=33).||1.55|0.27|0.3417
72485137|NCT00628251|144497781|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.01||||0.9877|TWO_SIDED|95.0|0.44|2.27||2-sided p-value|Regression, Cox|Analysis was performed using a Cox proportional hazards model with factors for treatment, BRCA status and platinum sensitivity.|A hazard ratio of \<1 favoured olaparib.|Analysis of olaparib 400 (n=32) versus liposomal doxorubicin (n=33).||2.27|0.44|0.9877
72512404|NCT01332019|144554950|SUPERIORITY_OR_OTHER||lesion mean ratio|0.49|||<|0.0001|TWO_SIDED|95.0|0.39|0.62||Lesion mean ratio (95% CI) and p-value for comparison between the every 2 weeks group and the every 4 weeks group, based on negative binomial regression, adjusted for 302 baseline number of T2 lesions.|negative binomial regression|||Week 96||0.62|0.39|<0.0001
72512405|NCT01332019|144554951|SUPERIORITY_OR_OTHER||lesion mean ratio|0.54|||<|0.0001|TWO_SIDED|95.0|0.43|0.68||Lesion mean ratio (95% CI) and p-value for comparison between the every 2 weeks group and the every 4 weeks group, based on negative binomial regression, adjusted for 105MS302 baseline number of Gd lesions.|negative binomial regression|||Week 48||0.68|0.43|<0.0001
72485138|NCT03684642|144497820|NON_INFERIORITY|Non-inferiority of Efpeglenatide vs. Dulaglutide was demonstrated if the upper bound of the two-sided 95% confidence interval (CI) for the difference between groups was \<=0.3%.|Least Square (LS) Mean difference|-0.03|STANDARD_ERROR_OF_MEAN|0.09|||TWO_SIDED|95.0|-0.2|0.14||||||A hierarchical step-down testing procedure was used to control type 1 error. Analysis was performed using ANCOVA model with the treatment groups, randomization strata, and geographical region as fixed classification effects, and baseline HbA1c value as a continuous covariate.||0.14|-0.20|
72485139|NCT03684642|144497820|NON_INFERIORITY|Non-inferiority of Efpeglenatide vs. Dulaglutide was demonstrated if the upper bound of the two-sided 95% CI for the difference between groups was \<=0.3%.|LS Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.09|||TWO_SIDED|95.0|-0.25|0.09||||||A hierarchical step-down testing procedure was used to control type 1 error. Analysis was performed using ANCOVA model with the treatment groups, randomization strata, and geographical region as fixed classification effects, and baseline HbA1c value as a continuous covariate.||0.09|-0.25|
72485140|NCT03684642|144497820|SUPERIORITY|||||||0.7064||||||Threshold for significance at the level of 0.05.|ANCOVA|||||||0.7064
72485141|NCT03684642|144497820|SUPERIORITY|||||||0.3427||||||Threshold for significance at the level of 0.05.|ANCOVA|||||||0.3427
72512406|NCT01332019|144554951|SUPERIORITY_OR_OTHER||lesion mean ratio|0.55|||<|0.0001|TWO_SIDED|95.0|0.43|0.71||Lesion mean ratio (95% CI) and p-value for comparison between the every 2 weeks group and the every 4 weeks group, based on negative binomial regression, adjusted for 105MS302 baseline number of Gd lesions.|negative binomial regression|||Week 96||0.71|0.43|<0.0001
72485142|NCT04556396|144497833|SUPERIORITY||Odds Ratio (OR)|0.2|||<|0.01|TWO_SIDED|95.0|0.1|0.4|||Chi-squared|||||0.4|0.1|<0.01
72485143|NCT02374021|144497859|SUPERIORITY||Mean Difference (Final Values)|-0.02||||0.79|TWO_SIDED|95.0|-0.19|0.15|||ANCOVA|||||0.15|-0.19|0.79
72485144|NCT02374021|144497860|SUPERIORITY||Mean Difference (Final Values)|0.01||||0.05|TWO_SIDED|95.0|-0.14|0.17|||ANCOVA|||||0.17|-0.14|0.05
72485145|NCT02374021|144497861|SUPERIORITY||Mean Difference (Final Values)|0.03||||0.05|TWO_SIDED|95.0|-0.11|0.18|||ANCOVA|||||0.18|-0.11|0.05
72485146|NCT02374021|144497862|SUPERIORITY||Mean Difference (Final Values)|-0.003||||0.05|TWO_SIDED|95.0|-0.2|0.19|||ANCOVA|||||0.19|-0.20|0.05
72485147|NCT02374021|144497863|SUPERIORITY||Mean Difference (Final Values)|-0.01||||0.05|TWO_SIDED|95.0|-0.17|0.16|||ANCOVA|||||0.16|-0.17|0.05
72485148|NCT01162239|144497890|OTHER|||||||0.62|||||||Chi-squared|||||||0.62
72485149|NCT01162239|144497891|OTHER|||||||0.91|||||||Chi-squared|||||||0.91
72402586|NCT01480076|144311686|SUPERIORITY_OR_OTHER|||||||0.004|||||||mixed effect model|||Month 12, PRMS. Mixed effect model for repeated measures with visit, baseline of percentage of regular activity productivity loss, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.0040
72485150|NCT00228566|144497892|SUPERIORITY_OR_OTHER||% Responders = 201/241|83.4||||||95.0|78.7|88.1|||Descriptive Statistics||The Overall Endpoint includes the last postbaseline value for each patient in the full analysis set, regardless of evaluation period. The Number of Responders (at least minimal improvement) at this Overall Endpoint equaled a total of 201 patients.|This was an open label study, with all patients receiving treatment with armodafinil||88.1|78.7|
72512407|NCT01332019|144554952|SUPERIORITY_OR_OTHER||||||<|0.0001||||||p-value for comparison between the every 2 weeks group and the every 4 weeks group, based on multiple logit regression, adjusted for 302 baseline number of T1 lesions.|Regression, Logistic|||Week 48||||<0.0001
72512408|NCT01332019|144554952|SUPERIORITY_OR_OTHER||||||<|0.0001||||||p-value for comparison between the every 2 weeks group and the every 4 weeks group, based on multiple logit regression, adjusted for 302 baseline number of T1 lesions.|Regression, Logistic|||Week 96||||<0.0001
72512409|NCT01332019|144554953|SUPERIORITY_OR_OTHER|||||||0.0012||||||p-value for comparison between the every 2 weeks group and the every 4 weeks group, based on multiple logit regression, adjusted for 302 baseline number of Gd-enhancing lesion.|Regression, Logistic|||Week 48||||0.0012
72512410|NCT01332019|144554953|SUPERIORITY_OR_OTHER|||||||0.0026||||||p-value for comparison between the every 2 weeks group and the every 4 weeks group, based on multiple logit regression, adjusted for 302 baseline number of Gd-enhancing lesion.|Regression, Logistic|||Week 96||||0.0026
72512411|NCT01332019|144554959|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.57||||0.006|TWO_SIDED|95.0|0.38|0.85||Based on Cox Proportional Hazards model, adjusted for 105MS302 baseline EDSS and age (\<40 vs \>=40).|Cox Proportional Hazards model||q2w/q4w|||0.85|0.38|0.0060
72512412|NCT03072719|144554987|SUPERIORITY_OR_OTHER||Least square (LS) mean difference|-0.19||||0.1774|TWO_SIDED|95.0|-0.46|0.09||From ANCOVA model: Treatment as fixed factor, baseline Schiff Sensitivity score as covariate.|ANCOVA||Difference is 0.454% stannous fluoride minus 0.76% sodium monofluorophosphate such that a negative difference favours first named treatment.|"H0 : The difference in Schiff Sensitivity Score at Day 14 between the experimental dentifrice and reference dentifrice is zero.~H1 : The difference in Schiff Sensitivity Score at Day 14 between the experimental dentifrice and reference dentifrice is not zero."||0.09|-0.46|0.1774
72512413|NCT01358877|144555048|SUPERIORITY||Hazard Ratio (HR)|0.81||||0.0446|TWO_SIDED|95.0|0.66|1.0||Statistical significance was controlled at a two-sided alpha level of 0.05.|Log Rank||Hazard ratio was estimated by Cox regression.|Analysis was performed using stratified log-rank test, which included nodal status, protocol version, central hormone receptor status, and adjuvant chemotherapy regimen as stratification factors in the randomization.||1.00|0.66|0.0446
72512414|NCT01358877|144555050|SUPERIORITY||Hazard Ratio (HR)|0.82||||0.043|TWO_SIDED|95.0|0.68|0.99||Statistical significance was controlled at a two-sided alpha level of 0.05.|Log Rank||Hazard ratio was estimated by Cox regression.|Analysis was performed using stratified log-rank test, which included nodal status, protocol version, central hormone receptor status, and adjuvant chemotherapy regimen as stratification factors in the randomization.||0.99|0.68|0.0430
72512415|NCT01358877|144555052|SUPERIORITY||Hazard Ratio (HR)|0.81||||0.0327|TWO_SIDED|95.0|0.67|0.98||Statistical significance was controlled at a two-sided alpha level of 0.05.|Log Rank||Hazard ratio was estimated by Cox regression.|Analysis was performed using stratified log-rank test, which included nodal status, protocol version, central hormone receptor status, and adjuvant chemotherapy regimen as stratification factors in the randomization.||0.98|0.67|0.0327
72512416|NCT01358877|144555054|SUPERIORITY||Hazard Ratio (HR)|0.89||||0.4673|TWO_SIDED|95.0|0.66|1.21||Statistical significance was controlled at a two-sided alpha level of 0.05.|Log Rank||Hazard ratio was estimated by Cox regression.|Analysis was performed using stratified log-rank test, which included nodal status, protocol version, central hormone receptor status, and adjuvant chemotherapy regimen as stratification factors in the randomization.||1.21|0.66|0.4673
72512417|NCT01358877|144555056|SUPERIORITY||Hazard Ratio (HR)|0.79||||0.043|TWO_SIDED|95.0|0.63|0.99|||Log Rank||Hazard ratio was estimated by Cox regression.|Analysis was performed using stratified log-rank test, which included nodal status, protocol version, central hormone receptor status, and adjuvant chemotherapy regimen as stratification factors in the randomization.||0.99|0.63|0.0430
72512418|NCT01358877|144555058|SUPERIORITY||Hazard Ratio (HR)|0.82||||0.1007|TWO_SIDED|95.0|0.64|1.04|||Log Rank||Hazard ratio was estimated by Cox regression.|Analysis was performed using stratified log-rank test, which included nodal status, protocol version, central hormone receptor status, and adjuvant chemotherapy regimen as stratification factors in the randomization.||1.04|0.64|0.1007
72512419|NCT01358877|144555060|SUPERIORITY||Treatment Difference|0.4|||||TWO_SIDED|95.0|0.0|0.8|||||The difference in percentage of participants with a primary cardiac event between the pertuzumab and placebo arms. The 95% confidence interval (CI) was estimated using Hauck-Anderson correction.|||0.8|0.0|
72512420|NCT01358877|144555061|SUPERIORITY||Treatment Difference|-0.1|||||TWO_SIDED|95.0|-1.0|0.9|||||95% CI was estimated using Hauck-Anderson correction.|||0.9|-1.0|
72512421|NCT01358877|144555062|SUPERIORITY||Treatment Difference|0.1|||||TWO_SIDED|95.0|-0.3|0.5|||||95% CI was estimated using Hauck-Anderson correction.|||0.5|-0.3|
72512422|NCT03575884|144555093|SUPERIORITY||Study_arm timepoint interactions|-27.32|||<|0.05|TWO_SIDED|95.0|-52.49|-2.14|||Mixed Models Analysis|||||-2.14|-52.49|<0.05
72512423|NCT04322994|144555110|OTHER|||||||0.18||||||The a priori threshold for statistical significance was 0.05.|Chi-squared|Chi-squared test of independence||Analysis of between-group difference for participants with any desaturation event.||||0.18
72512424|NCT04322994|144555110|OTHER|||||||0.26||||||The a priori threshold for statistical significance was 0.05.|Chi-squared|Chi-squared test of independence||Analysis of between-group difference for participants with 1 desaturation event versus 2 or more events.||||0.26
72512425|NCT04322994|144555111|OTHER|||||||0.26||||||The a priori threshold for statistical significance was 0.05.|Chi-squared|Chi-squared test of independence||Analysis of between-group difference for participants with at any qualifying desaturation event.||||0.26
72512426|NCT04322994|144555111|OTHER|||||||0.08||||||The a priori threshold for statistical significance was 0.05.|Chi-squared|Chi-squared test of independence||Analysis of between-group difference for participants with 1 qualifying desaturation event versus 2 or more qualifying events.||||0.08
72567580|NCT03864042|144666294|OTHER||Geometric LS Mean Ratio|1.26|||||TWO_SIDED|90.0|0.8|1.98|||||Day 1 / Day -7|||1.98|0.800|
72485151|NCT00232141|144497911|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.25|STANDARD_ERROR_OF_MEAN|0.29||0.3914||95.0|-0.83|0.32||The analysis procedures planned will control the Type I error for the primary analysis. No multiplicity adjustment is needed for this two-group study.|ANCOVA|||Primary hypotheses : null (H0): µA=µP vs alternative (HA): µA≠µP (µA and µP represent true means for primary endpoint in active treatment \& placebo groups respectively). Assumptions in power calculation: 2-sided test with type I error at α =0.05, type II error at β =0.10, \& a common s.d of 2.2 for primary endpoint (based on previous clinical trial data). With n=150 subjects/ group (300 subjects overall) at least 90% power to detect a treatment difference of at least 1.1 in primary endpoint||0.32|-0.83|0.3914
72485152|NCT00232141|144497912|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.45|STANDARD_ERROR_OF_MEAN|0.18||0.0131||95.0|-0.81|-0.1||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 1||-0.10|-0.81|0.0131
72485153|NCT00232141|144497912|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.49|STANDARD_ERROR_OF_MEAN|0.24||0.0393||95.0|-0.96|-0.02||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 2||-0.02|-0.96|0.0393
72485154|NCT00232141|144497912|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.54|STANDARD_ERROR_OF_MEAN|0.28||0.0554||95.0|-1.08|0.01||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 3||0.01|-1.08|0.0554
72485155|NCT00232141|144497912|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.42|STANDARD_ERROR_OF_MEAN|0.29||0.1513||95.0|-0.99|0.15||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 4||0.15|-0.99|0.1513
72485156|NCT00232141|144497912|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.29|STANDARD_ERROR_OF_MEAN|0.3||0.3345||95.0|-0.89|0.3||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 5||0.30|-0.89|0.3345
72485157|NCT00232141|144497912|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.53|STANDARD_ERROR_OF_MEAN|0.31||0.0879||95.0|-1.13|0.08||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 6||0.08|-1.13|0.0879
72512427|NCT04322994|144555112|OTHER|||||||0.28|||||||Chi-squared|||Analysis of between-group difference for participants with any qualifying event.||||0.28
72512428|NCT04322994|144555112|OTHER|||||||0.38||||||The a priori threshold for statistical significance was 0.05.|Chi-squared|||Analysis of between-group difference for participants with 1 qualifying event versus 2 or more events.||||0.38
72485158|NCT00232141|144497912|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.69|STANDARD_ERROR_OF_MEAN|0.32||0.0307||95.0|-1.32|-0.07||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 7||-0.07|-1.32|0.0307
72485159|NCT00232141|144497912|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.75|STANDARD_ERROR_OF_MEAN|0.31||0.0156||95.0|-1.36|-0.14||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 8||-0.14|-1.36|0.0156
72485160|NCT00232141|144497912|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.53|STANDARD_ERROR_OF_MEAN|0.32||0.0981||95.0|-1.15|0.1||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 9||0.10|-1.15|0.0981
72512429|NCT04322994|144555113|OTHER|||||||0.88||||||The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|||Analysis of between-group difference for participants with at any qualifying desaturation event.||||0.88
72567581|NCT03864042|144666294|OTHER||Geometric LS Mean Ratio|0.827|||||TWO_SIDED|90.0|0.526|1.3|||||Day 14 / Day -7|||1.30|0.526|
72512430|NCT04322994|144555114|OTHER|||||||0.14||||||The a priori threshold for statistical significance was 0.05.|Chi-squared, Corrected|Chi-squared test of independence||Analysis of between-group difference for participants with any surgical interruption.||||0.14
72512431|NCT04322994|144555114|OTHER|||||||0.21||||||The a priori threshold for statistical significance was 0.05.|Chi-squared|Chi-squared test of independence||Analysis of between-group difference for participants with 1 surgical interruption versus 2 or more interruptions.||||0.21
72512432|NCT03664193|144555121|OTHER|Simple descriptive feasibility proportion and exact 95% confidence interval for radiation dose of 37.5 Gy.|Proportion (percent)|30.0|||||TWO_SIDED|95.0|14.7|49.3||||||||49.3|14.7|
72567582|NCT03864042|144666295|OTHER||Geometric LS Mean Ratio|0.98|||||TWO_SIDED|90.0|0.688|1.39|||||Day 1 / Day -7|||1.39|0.688|
72567583|NCT03864042|144666295|OTHER||Geometric LS Mean Ratio|0.633|||||TWO_SIDED|90.0|0.445|0.9|||||Day 14 / Day -7|||0.900|0.445|
72567584|NCT03864042|144666296|OTHER||Geometric LS Mean Ratio|2.79|||||TWO_SIDED|90.0|2.08|3.74|||||Day 1 / Day -7|||3.74|2.08|
72567585|NCT03864042|144666296|OTHER||Geometric LS Mean Ratio|1.57|||||TWO_SIDED|90.0|1.17|2.11|||||Day 14 / Day -7|||2.11|1.17|
72567586|NCT03864042|144666297|OTHER||Geometric LS Mean Ratio|0.769|||||TWO_SIDED|90.0|0.637|0.928|||||Day 1 / Day -7|||0.928|0.637|
72567587|NCT03864042|144666297|OTHER||Geometric LS Mean Ratio|0.736|||||TWO_SIDED|90.0|0.61|0.889|||||Day 14 / Day -7|||0.889|0.610|
72402587|NCT01480076|144311687|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Overall, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline PCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
72402588|NCT01480076|144311687|SUPERIORITY_OR_OTHER|||||||0.6769|||||||mixed effect model|||Overall, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline PCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.6769
72402589|NCT01480076|144311687|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Overall, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline PCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
72402590|NCT01480076|144311687|SUPERIORITY_OR_OTHER|||||||0.578|||||||mixed effect model|||Overall, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline PCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.5780
72402591|NCT01480076|144311687|SUPERIORITY_OR_OTHER||difference of LS means|3.4|STANDARD_ERROR_OF_MEAN|0.68|<|0.0001|TWO_SIDED||||||mixed effect model|||Overall, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline PCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
72402592|NCT01480076|144311687|SUPERIORITY_OR_OTHER||difference of LS means|4.5|STANDARD_ERROR_OF_MEAN|1.1|<|0.0001|TWO_SIDED||||||mixed effect model|||Overall, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline PCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
72402593|NCT01480076|144311687|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 3, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline PCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
72402594|NCT01480076|144311687|SUPERIORITY_OR_OTHER|||||||0.8886|||||||mixed effect model|||Month 3, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline PCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.8886
72402595|NCT01480076|144311687|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 3, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline PCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
72512433|NCT03664193|144555121|OTHER|Simple descriptive feasibility proportion and exact 95% confidence interval for radiation dose of 40.0 Gy.|Proportion (percent)|46.7|||||TWO_SIDED|95.0|28.3|65.7||||||||65.7|28.3|
72512434|NCT03664193|144555121|OTHER|Simple descriptive feasibility proportion and exact 95% confidence interval for radiation dose of 42.5 Gy.|Proportion (percent)|6.7|||||TWO_SIDED|95.0|0.8|22.1||||||||22.1|0.8|
72512435|NCT03664193|144555121|OTHER|Simple descriptive feasibility proportion and exact 95% confidence interval for radiation dose of 45.0 Gy.|Proportion (percent)|16.7|||||TWO_SIDED|95.0|5.6|34.7||||||||34.7|5.6|
72402596|NCT01480076|144311687|SUPERIORITY_OR_OTHER|||||||0.3221|||||||mixed effect model|||Month 3, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline PCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.3221
72402597|NCT01480076|144311687|SUPERIORITY_OR_OTHER||difference of LS means|3.9|STANDARD_ERROR_OF_MEAN|0.75|<|0.0001|TWO_SIDED||||||mixed effect model|||Month 3, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline PCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
72402598|NCT01480076|144311687|SUPERIORITY_OR_OTHER||difference of LS means|5.3|STANDARD_ERROR_OF_MEAN|1.23|<|0.0001|TWO_SIDED||||||mixed effect model|||Month 3, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline PCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
72512436|NCT03664193|144555122|OTHER|Simple proportion and exact 95% confidence interval.|Proportion (percent)|100.0|||||TWO_SIDED|95.0|88.4|100.0||||||||100.0|88.4|
72567588|NCT03864042|144666298|OTHER||Geometric LS Mean Ratio|0.993|||||TWO_SIDED|90.0|0.803|1.23|||||Day 1 / Day -7|||1.23|0.803|
72567589|NCT03864042|144666298|OTHER||Geometric LS Mean Ratio|1.48|||||TWO_SIDED|90.0|1.2|1.83|||||Day 14 / Day -7|||1.83|1.20|
72567590|NCT03864042|144666299|OTHER||Geometric LS Mean Ratio|1.45|||||TWO_SIDED|90.0|0.902|2.32|||||Day 1 / Day -7|||2.32|0.902|
72567591|NCT03864042|144666299|OTHER||Geometric LS Mean Ratio|1.18|||||TWO_SIDED|90.0|0.72|1.93|||||Day 14 / Day -7|||1.93|0.720|
72485161|NCT00232141|144497912|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.32|STANDARD_ERROR_OF_MEAN|0.31||0.306||95.0|-0.93|0.29||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 10||0.29|-0.93|0.3060
72485162|NCT00232141|144497912|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.43|STANDARD_ERROR_OF_MEAN|0.33||0.1874||95.0|-1.08|0.21||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 11||0.21|-1.08|0.1874
72485163|NCT00232141|144497912|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.56|STANDARD_ERROR_OF_MEAN|0.34||0.1025||95.0|-1.22|0.11||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 12||0.11|-1.22|0.1025
72485164|NCT00232141|144497912|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.63|STANDARD_ERROR_OF_MEAN|0.34||0.0662||95.0|-1.3|0.04||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 13||0.04|-1.30|0.0662
72485165|NCT00232141|144497912|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.49|STANDARD_ERROR_OF_MEAN|0.37||0.1856||95.0|-1.21|0.24||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 14||0.24|-1.21|0.1856
72485166|NCT00232141|144497912|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.08|STANDARD_ERROR_OF_MEAN|0.3||0.7925||95.0|-0.66|0.5||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Endpoint||0.50|-0.66|0.7925
72485167|NCT00232141|144497913|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.18||||0.1191||95.0|0.802|5.935||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|Cochran-Mantel-Haenszel|||Table above shows results of statistical analysis for Week 1||5.935|0.802|0.1191
72485168|NCT00232141|144497913|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.24||||0.5041||95.0|0.666|2.301||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|Cochran-Mantel-Haenszel|||Table above shows results of statistical analysis for Week 2||2.301|0.666|0.5041
72485169|NCT00232141|144497913|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.13||||0.6859||95.0|0.638|1.985||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|Cochran-Mantel-Haenszel|||Table above shows results of statistical analysis for Week 3||1.985|0.638|0.6859
72485170|NCT00232141|144497913|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.25||||0.414||95.0|0.735|2.116||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|Cochran-Mantel-Haenszel|||Table above shows results of statistical analysis for Week 4||2.116|0.735|0.4140
72485171|NCT00232141|144497913|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.07||||0.7852||95.0|0.644|1.794||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|Cochran-Mantel-Haenszel|||Table above shows results of statistical analysis for Week 5||1.794|0.644|0.7852
72485172|NCT00232141|144497913|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.09||||0.7399||95.0|0.654|1.817||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|Cochran-Mantel-Haenszel|||Table above shows results of statistical analysis for Week 6||1.817|0.654|0.7399
72485173|NCT00232141|144497913|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.57||||0.1055||95.0|0.913|2.701||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|Cochran-Mantel-Haenszel|||Table above shows results of statistical analysis for Week 7||2.701|0.913|0.1055
72485174|NCT00232141|144497913|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.41||||0.2107||95.0|0.829|2.401||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|Cochran-Mantel-Haenszel|||Table above shows results of statistical analysis for Week 8||2.401|0.829|0.2107
72542481|NCT00106028|144614698|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.584||||0.0416|TWO_SIDED|95.0|0.348|0.98||Non-Vertebral Fracture|Wald Test|Hazard Ratio and 95% CI based on Anderson-Gill mean intensity model stratified by age group with treatment and pooled-country as covariates.||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.||0.980|0.348|0.0416
72485175|NCT00232141|144497913|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.19||||0.527||95.0|0.697|2.046||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|Cochran-Mantel-Haenszel|||Table above shows results of statistical analysis for Week 9||2.046|0.697|0.5270
72402599|NCT01480076|144311687|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 6, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline PCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
72402600|NCT01480076|144311687|SUPERIORITY_OR_OTHER|||||||0.4668|||||||mixed effect model|||Month 6, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline PCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.4668
72402601|NCT01480076|144311687|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 6, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline PCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
72402602|NCT01480076|144311687|SUPERIORITY_OR_OTHER|||||||0.5695|||||||mixed effect model|||Month 6, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline PCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.5695
72402603|NCT01480076|144311687|SUPERIORITY_OR_OTHER||difference of LS means|2.4|STANDARD_ERROR_OF_MEAN|0.88||0.0058|TWO_SIDED||||||mixed effect model|||Month 6, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline PCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0058
72512437|NCT02345252|144555126|NON_INFERIORITY|A sample size of 275 HIV-1 infected participants per treatment group would provide 85% power to detect a noninferiority margin of 8% in the Week 48 response rate difference between the FTC/RPV/TAF group and FTC/RPV/TDF group. For sample size and power computation, it is assumed that both treatment groups will have a response rate of 89% (based on Gilead Study GS-US-292-0109), that a noninferiority margin is 8%, and that the significance level of the test is at a one-sided alpha level of 0.025.|Difference in Percentages|-0.3|||||TWO_SIDED|95.001|-4.2|3.7|||||The difference in percentages and its 95.001% confidence interval (CI) were calculated based on an unconditional exact method using 2 inverted 1-sided tests.|The null hypothesis was that the percentage of participants with HIV-1 RNA \< 50 copies/mL at Week 48 in the FTC/RPV/TAF group was at least 8% lower than the rate in the FTC/RPV/TDF group; the alternative hypothesis was that the percentage of participants with HIV-1 RNA \< 50 copies/mL in the FTC/RPV/TAF group was less than 8% lower than that in the FTC/RPV/TDF group.||3.7|-4.2|
72567592|NCT03864042|144666300|OTHER||Geometric LS Mean Ratio|1.47|||||TWO_SIDED|90.0|0.915|2.36|||||Day 1 / Day -7|||2.36|0.915|
72402604|NCT01480076|144311687|SUPERIORITY_OR_OTHER||difference of LS means|4.6|STANDARD_ERROR_OF_MEAN|1.4||0.001|TWO_SIDED||||||mixed effect model|||Month 6, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline PCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0010
72402605|NCT01480076|144311687|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 9, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline PCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
72402606|NCT01480076|144311687|SUPERIORITY_OR_OTHER|||||||0.204|||||||mixed effect model|||Month 9, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline PCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.2040
72485176|NCT00232141|144497913|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.89||||0.6845||95.0|0.513|1.546||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|Cochran-Mantel-Haenszel|||Table above shows results of statistical analysis for Week 10||1.546|0.513|0.6845
72485177|NCT00232141|144497913|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.92||||0.7737||95.0|0.522|1.619||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|Cochran-Mantel-Haenszel|||Table above shows results of statistical analysis for Week 11||1.619|0.522|0.7737
72485178|NCT00232141|144497913|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.04||||0.8853||95.0|0.597|1.818||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|Cochran-Mantel-Haenszel|||Table above shows results of statistical analysis for Week 12||1.818|0.597|0.8853
72485179|NCT00232141|144497913|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.09||||0.7712||95.0|0.612|1.946||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|Cochran-Mantel-Haenszel|||Table above shows results of statistical analysis for Week 13||1.946|0.612|0.7712
72567593|NCT03864042|144666300|OTHER||Geometric LS Mean Ratio|0.851|||||TWO_SIDED|90.0|0.519|1.39|||||Day 14 / Day -7|||1.39|0.519|
72485180|NCT00232141|144497913|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.02||||0.9586||95.0|0.574|1.796||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|Cochran-Mantel-Haenszel|||Table above shows results of statistical analysis for Week 14||1.796|0.574|0.9586
72402607|NCT01480076|144311687|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 9, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline PCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
72485181|NCT00232141|144497913|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.79||||0.3482||95.0|0.486|1.283||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|Cochran-Mantel-Haenszel|||Table above shows results of statistical analysis for Endpoint-BOCF||1.283|0.486|0.3482
72485182|NCT00232141|144497914|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.62||||0.1132||95.0|0.882|2.969||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|Cochran-Mantel-Haenszel|||Table above shows results of statistical analysis for Week 1||2.969|0.882|0.1132
72485183|NCT00232141|144497914|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.2||||0.4687||95.0|0.731|1.978||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|Cochran-Mantel-Haenszel|||Table above shows results of statistical analysis for Week 2||1.978|0.731|0.4687
72485184|NCT00232141|144497914|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.44||||0.1546||95.0|0.877|2.375||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|Cochran-Mantel-Haenszel|||Table above shows results of statistical analysis for Week 3||2.375|0.877|0.1546
72485185|NCT00232141|144497914|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.23||||0.4216||95.0|0.7444|2.025||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|Cochran-Mantel-Haenszel|||Table above shows results of statistical analysis for Week 4||2.025|0.7444|0.4216
72512438|NCT02345252|144555126|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.00
72402608|NCT01480076|144311687|SUPERIORITY_OR_OTHER|||||||0.6306|||||||mixed effect model|||Month 9, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline PCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.6306
72402609|NCT01480076|144311687|SUPERIORITY_OR_OTHER||difference of LS means|3.9|STANDARD_ERROR_OF_MEAN|0.9|<|0.0001|TWO_SIDED||||||mixed effect model|||Month 9, Responder (Taking Additional MS Therapy) versus Non- responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline PCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
72402610|NCT01480076|144311687|SUPERIORITY_OR_OTHER||difference of LS means|4.7|STANDARD_ERROR_OF_MEAN|1.51||0.002|TWO_SIDED||||||mixed effect model|||Month 9, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline PCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0020
72402611|NCT01480076|144311687|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 12, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline PCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
72402612|NCT01480076|144311687|SUPERIORITY_OR_OTHER|||||||0.4052|||||||mixed effect model|||Month 12, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline PCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.4052
72402613|NCT01480076|144311687|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 12, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline PCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
72402614|NCT01480076|144311687|SUPERIORITY_OR_OTHER|||||||0.8626|||||||mixed effect model|||Month 12, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline PCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.8626
72485186|NCT00232141|144497914|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.92||||0.7479||95.0|0.556|1.527||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|Cochran-Mantel-Haenszel|||Table above shows results of statistical analysis for Week 5||1.527|0.556|0.7479
72512439|NCT02403830|144555136|SUPERIORITY||Mean Difference (Final Values)|-32.0||||0.261|TWO_SIDED|95.0|-90.0|25.0|||Mixed Models Analysis|||||25|-90|0.261
72512440|NCT00779324|144555144|OTHER||Difference in percents|-0.4||||0.9554|TWO_SIDED|95.0|-14.7|13.9|||Chi-squared|||||13.9|-14.7|0.9554
72512441|NCT00779324|144555145|OTHER|||||||0.96|||||||Wilcoxon (Mann-Whitney)|||||||0.96
72512442|NCT00779324|144555146|OTHER||Difference in percents|10.8||||0.1662|TWO_SIDED|95.0|-4.2|25.8|||Chi-squared|||||25.8|-4.2|0.1662
72512443|NCT00779324|144555147|OTHER|||||||0.3488|||||||Wilcoxon (Mann-Whitney)|||||||0.3488
72485187|NCT00232141|144497914|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.8||||0.3842||95.0|0.481|1.33||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|Cochran-Mantel-Haenszel|||Table above shows results of statistical analysis for Week 6||1.330|0.481|0.3842
72485188|NCT00232141|144497914|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.05||||0.845||95.0|0.627|1.769||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|Cochran-Mantel-Haenszel|||Table above shows results of statistical analysis for Week 7||1.769|0.627|0.8450
72485189|NCT00232141|144497914|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.48||||0.1602||95.0|0.864|2.527||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|Cochran-Mantel-Haenszel|||Table above shows results of statistical analysis for Week 8||2.527|0.864|0.1602
72485190|NCT00232141|144497914|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.12||||0.6815||95.0|0.66|1.89||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|Cochran-Mantel-Haenszel|||Table above shows results of statistical analysis for Week 9||1.890|0.660|0.6815
72485191|NCT00232141|144497914|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.85||||0.5635||95.0|0.486|1.482||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|Cochran-Mantel-Haenszel|||Table above shows results of statistical analysis for Week 10||1.482|0.486|0.5635
72485192|NCT00232141|144497914|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.21||||0.49||95.0|0.699|2.104||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|Cochran-Mantel-Haenszel|||Table above shows results of statistical analysis for Week 11||2.104|0.699|0.4900
72485193|NCT00232141|144497914|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.48||||0.1602||95.0|0.856|2.575||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|Cochran-Mantel-Haenszel|||Table above shows results of statistical analysis for Week 12||2.575|0.856|0.1602
72485194|NCT00232141|144497914|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.17||||0.5819||95.0|0.663|2.079||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|Cochran-Mantel-Haenszel|||Table above shows results of statistical analysis for Week 13||2.079|0.663|0.5819
72485195|NCT00232141|144497914|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.37||||0.2796||95.0|0.768|2.432||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|Cochran-Mantel-Haenszel|||Table above shows results of statistical analysis for Week 14||2.432|0.768|0.2796
72485196|NCT00232141|144497914|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.86||||0.5437||95.0|0.534|1.39||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|Cochran-Mantel-Haenszel|||Table above shows results of statistical analysis for Endpoint-BOCF||1.390|0.534|0.5437
72485197|NCT00232141|144497915|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.54|STANDARD_ERROR_OF_MEAN|2.53||0.5425||95.0|-3.44|6.52||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Disturbance.||6.52|-3.44|0.5425
72485198|NCT00232141|144497915|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.25|STANDARD_ERROR_OF_MEAN|0.25||0.3184||95.0|-0.75|0.25||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Quantity||0.25|-0.75|0.3184
72485199|NCT00232141|144497915|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.04|STANDARD_ERROR_OF_MEAN|2.92||0.9886||95.0|-5.81|5.72||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Adequacy||5.72|-5.81|0.9886
72485200|NCT00232141|144497915|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.41|STANDARD_ERROR_OF_MEAN|2.51||0.5742||95.0|-3.53|6.35||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Awaken Short of Breath or with Headache||6.35|-3.53|0.5742
72512444|NCT00779324|144555149|OTHER||Difference in percents|6.4||||0.38|TWO_SIDED|95.0|-7.2|20.0|||Chi-squared|||||20|-7.2|0.38
72512445|NCT00779324|144555150|OTHER||Difference in percents|11.7||||0.1373|TWO_SIDED|95.0|-3.3|26.7|||Chi-squared|||||26.7|-3.3|0.1373
72512446|NCT00779324|144555151|OTHER|||||||0.12|||||||Wilcoxon (Mann-Whitney)|||||||0.12
72512447|NCT00779324|144555152|OTHER|||||||0.0353|||||||Wilcoxon (Mann-Whitney)|||||||0.0353
72512448|NCT02196038|144555190|SUPERIORITY||Mean Difference (Final Values)|1.5|||<|0.0001|TWO_SIDED|95.0|0.9|2.0|||joint model|Joint model of ANCOVA plus survival||||2.0|0.9|<0.0001
72512449|NCT02196038|144555191|SUPERIORITY||Rate Ratio|0.93||||0.59|TWO_SIDED|95.0|0.66|1.19|||Joint Model|Joint model of Poisson regression and survival||||1.19|0.66|0.59
72567594|NCT03864042|144666301|OTHER||Geometric LS Mean Ratio|1.2|||||TWO_SIDED|90.0|0.775|1.87|||||Day 1 / Day -7|||1.87|0.775|
72567595|NCT03864042|144666301|OTHER||Geometric LS Mean Ratio|0.94|||||TWO_SIDED|90.0|0.593|1.49|||||Day 14 / Day -7|||1.49|0.593|
72567596|NCT03864042|144666302|OTHER||Geometric LS Mean Ratio|1.18|||||TWO_SIDED|90.0|0.83|1.67|||||Day 1 / Day -7|||1.67|0.830|
72567597|NCT03864042|144666302|OTHER||Geometric LS Mean Ratio|0.979|||||TWO_SIDED|90.0|0.68|1.41|||||Day 14 / Day -7|||1.41|0.680|
72402615|NCT01480076|144311687|SUPERIORITY_OR_OTHER||difference of LS means|3.3|STANDARD_ERROR_OF_MEAN|0.93||0.0004|TWO_SIDED||||||mixed effect model|||Month 12, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline PCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0004
72402616|NCT01480076|144311687|SUPERIORITY_OR_OTHER||difference of LS means|3.3|STANDARD_ERROR_OF_MEAN|1.49||0.0263|TWO_SIDED||||||mixed effect model|||Month 12, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline PCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0263
72485201|NCT00232141|144497915|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.4|STANDARD_ERROR_OF_MEAN|2.5||0.5775||95.0|-3.54|6.33||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Somnolence||6.33|-3.54|0.5775
72485202|NCT00232141|144497915|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|9.34|STANDARD_ERROR_OF_MEAN|3.21||0.004||95.0|3.02|15.66||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Snoring||15.66|3.02|0.0040
72485203|NCT00232141|144497915|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.07|STANDARD_ERROR_OF_MEAN|1.98||0.5882||95.0|-2.83|4.97||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Sleep Problems Index I||4.97|-2.83|0.5882
72485204|NCT00232141|144497915|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.42|STANDARD_ERROR_OF_MEAN|1.89||0.4516||95.0|-2.3|5.14||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Sleep Problems Index II||5.14|-2.30|0.4516
72485205|NCT00232141|144497916|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.26|STANDARD_ERROR_OF_MEAN|0.39||0.5105||95.0|-0.51|1.03||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Anxiety||1.03|-0.51|0.5105
72485206|NCT00232141|144497916|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.42|STANDARD_ERROR_OF_MEAN|0.37||0.2513||95.0|-0.3|1.14||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Depression||1.14|-0.30|0.2513
72485207|NCT00232141|144497917|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.15|STANDARD_ERROR_OF_MEAN|0.27||0.5834||95.0|-0.38|0.67||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Pain Severity Index||0.67|-0.38|0.5834
72485208|NCT00232141|144497917|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.07|STANDARD_ERROR_OF_MEAN|0.25||0.7783||95.0|-0.43|0.57||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Pain Interference Index||0.57|-0.43|0.7783
72485209|NCT00232141|144497918|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.19|STANDARD_ERROR_OF_MEAN|0.27||0.4776||95.0|-0.73|0.34||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||||0.34|-0.73|0.4776
72485210|NCT00232141|144497919|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0077||95.0||||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|Cochran-Mantel-Haenszel|||||||0.0077
72485211|NCT00232141|144497920|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3852||95.0||||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|Cochran-Mantel-Haenszel|||||||0.3852
72485212|NCT00232141|144497921|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.03|STANDARD_ERROR_OF_MEAN|0.03||0.3097||95.0|-0.03|0.1||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Burning||0.10|-0.03|0.3097
72485213|NCT00232141|144497921|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.03||0.6147||95.0|-0.07|0.04||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Pressing||0.04|-0.07|0.6147
72567598|NCT03864042|144666303|OTHER||Geometric LS Mean Ratio|0.798|||||TWO_SIDED|90.0|0.585|1.09|||||Day 21 / Day 14|||1.09|0.585|
72485214|NCT00232141|144497921|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.03||0.6838||95.0|-0.05|0.07||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Paroxysmal||0.07|-0.05|0.6838
72512450|NCT02402218|144555241|SUPERIORITY|||||||0.11||||||For the primary and secondary outcomes, the proportion of participants with the outcome in each group was compared using a chi-square test.|Chi-squared|||Sample size was based on an estimated HCV treatment initiation rate of 50% in the UC group (based on a 33% rate observed during the interferon era) and 80% in the intervention groups, a significance level of 0.05, a desired ratio of participants in the intervention group compared to UC group of 3 to 2, and power of 80% to detect this difference between groups. The study was not powered to detect differences between the peer and cash groups.||||.11
72512451|NCT02402218|144555242|SUPERIORITY|||||||0.22|||||||Chi-squared|||||||.22
72485215|NCT00232141|144497921|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.03||0.6479||95.0|-0.07|0.04||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Evoked||0.04|-0.07|0.6479
72485216|NCT00232141|144497921|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.04|STANDARD_ERROR_OF_MEAN|0.03||0.1849||95.0|-0.02|0.11||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Paresthesia/dysesthesia||0.11|-0.02|0.1849
72485217|NCT00232141|144497921|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.0||0.5898||95.0|0.0|0.0||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Total Score||0|0|0.5898
72485218|NCT00232141|144497922|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.12|STANDARD_ERROR_OF_MEAN|0.29||0.6865||95.0|-0.45|0.68||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Static mechanical allodynia||0.68|-0.45|0.6865
72485219|NCT00232141|144497922|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.22|STANDARD_ERROR_OF_MEAN|0.25||0.3787||95.0|-0.71|0.27||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Dynamic mechanical allodynia||0.27|-0.71|0.3787
72512452|NCT02402218|144555244|SUPERIORITY|||||||0.33|||||||Chi-squared|||changes in the frequency of drug and alcohol use before and during treatment were compared using chi-square tests to evaluate the safety of cash incentives.||||0.33
72512453|NCT02402218|144555245|SUPERIORITY|||||||0.3||||||changes in the frequency of drug and alcohol use before and during treatment were compared using chi-square tests to evaluate the safety of cash incentives.|Chi-squared|||||||0.30
72512454|NCT03807739|144555247|EQUIVALENCE|Equivalence margin 80% - 125%|Geometric LS Mean Ratio|1.2471|||||TWO_SIDED|90.0|1.1149|1.3951||||||||1.3951|1.1149|
72512455|NCT03807739|144555247|EQUIVALENCE|Equivalence margin 80% - 125%|Geometric LS Mean Ratio|0.9864|||||TWO_SIDED|90.0|0.8531|1.1405||||||||1.1405|0.8531|
72512456|NCT03807739|144555249|EQUIVALENCE|Equivalence margin 80% - 125%|Geometric LS Mean Ratio|1.2203|||||TWO_SIDED|90.0|1.1175|1.3327||||||||1.3327|1.1175|
72567599|NCT03864042|144666304|OTHER||Geometric LS Mean Ratio|1.02|||||TWO_SIDED|90.0|0.935|1.11|||||Day 21 / Day 14|||1.11|0.935|
72567600|NCT03864042|144666305|OTHER||Geometric LS Mean Ratio|0.762|||||TWO_SIDED|90.0|0.613|0.945|||||Day 21 / Day 14|||0.945|0.613|
72512457|NCT03807739|144555249|EQUIVALENCE|Equivalence margin 80% - 125%|Geometric LS Mean Ratio|0.9947|||||TWO_SIDED|90.0|0.8266|1.1968||||||||1.1968|0.8266|
72512458|NCT00789191|144555257|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.55||||0.001||95.0|-0.77|-0.33||No corrections to adjust for multiplicity were performed. Statistical significance threshold was p\<0.05.|ANCOVA|Analysis of covariance (ANCOVA) was used; baseline HbA1c was included as covariate and treatment, stratification and country was included as factors||Null hypothesis: Difference between mean HbA1c in the two treatment arms is equal to zero. Power calculation: Assuming a standard deviation of 1.0 for HbA1c, 100 subjects in each treatment arm would be required to obtain a power of 80% for detecting a HbA1c difference of 0.4%||-0.33|-0.77|0.0010
72512459|NCT00789191|144555258|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.2||||0.001||95.0|1.65|6.19||No corrections to adjust for multiplicity were performed. Statistical significance threshold was p\<0.05.|Regression, Logistic|Treatment group comparison using logistic regression model incl.treatment,stratification factor, country as fixed effects, baseline HbA1c as covariate||Null hypothesis: Odds ratio is equal to one.||6.19|1.65|0.0010
72512460|NCT00789191|144555259|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.47||||0.008||95.0|1.26|4.81||No corrections to adjust for multiplicity were performed. Statistical significance threshold was p\<0.05.|Regression, Logistic|Treatment group comparison using logistic regression model incl.treatment,stratification factor, country as fixed effects, baseline HbA1c as covariate||Null hypothesis: Odds ratio is equal to one.||4.81|1.26|0.0080
72512461|NCT00789191|144555260|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.23||||0.063||95.0|0.96|5.2||No corrections to adjust for multiplicity were performed. Statistical significance threshold was p\<0.05.|Regression, Logistic|Treatment group comparison using logistic regression model incl.treatment,stratification factor, country as fixed effects, baseline HbA1c as covariate||Null hypothesis: Odds ratio is equal to one.||5.20|0.96|0.063
72567601|NCT03864042|144666306|OTHER||Geometric LS Mean Ratio|1.06|||||TWO_SIDED|90.0|0.929|1.22|||||Day 21 / Day 14|||1.22|0.929|
72567602|NCT02220725|144666424|SUPERIORITY||Hodges-Lehman estimate of shift|-70.14|||<|0.0001|TWO_SIDED|95.0|-85.43|-65.91|||2-sided test exact Wilcoxon rank-sum tes|||||-65.91|-85.43|<0.0001
72567603|NCT02220725|144666424|SUPERIORITY||Hodges-Lehman estimate of shift|-51.87|||<|0.0001|TWO_SIDED|95.0|-57.95|-47.03|||2-sided test exact Wilcoxon rank-sum tes|||||-47.03|-57.95|<0.0001
72567604|NCT02220725|144666425|SUPERIORITY||Hodges-Lehman estimate of shift|-74.45|||<|0.0001|TWO_SIDED|95.0|-78.92|-64.45|||2-sided test exact Wilcoxon rank-sum tes|||||-64.45|-78.92|<0.0001
72567605|NCT02220725|144666427|SUPERIORITY||Hodges-Lehmann Estimate of Shift|-18.0|||<|0.0001|TWO_SIDED|95.0|-23.05|-12.73|||2-sided test exact Wilcoxon rank-sum tes|||||-12.73|-23.05|<0.0001
72402617|NCT01480076|144311688|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Overall, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline MCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
72567606|NCT02220725|144666428|SUPERIORITY||Hodges-Lehman estimate of shift|1142.66|||<|0.0001|TWO_SIDED|95.0|1006.1|1281.4|||2-sided test exact Wilcoxon rank-sum tes|||||1281.40|1006.10|<0.0001
72567607|NCT02220725|144666428|SUPERIORITY||Hodges-Lehman estimate of shift|1205.05|||<|0.0001|TWO_SIDED|95.0|1034.17|1400.79|||2-sided test exact Wilcoxon rank-sum tes|||||1400.79|1034.17|<0.0001
72567608|NCT00103402|144666462|SUPERIORITY|The primary analysis compared rates for the primary outcome between study groups, using the exact conditional test version of the Mantel-Haenszel test to control for clustering by clinical center.|Risk Difference (RD)|0.1||||0.99|TWO_SIDED|95.0|-11.2|11.0|||Mantel Haenszel|The exact conditional test version of the Mantel-Haenszel test was used to control for clustering by clinical center.||Sample-size calculations were based on a 2-sided alpha of 0.05 with 80% power to detect a difference of 20 between response rates (40% placebo and 60% alfuzosin) for the Fisher's exact test. We calculated that a total sample of 270 participants would be required (135 per study group). This proposed sample size included a 20% increase to adjust for clustering within clinical sites and a 5% increase for interim monitoring.||11.0|-11.2|0.99
72567609|NCT00103402|144666463|SUPERIORITY|The primary analysis compared rates for the primary outcome between study groups, using the exact conditional test version of the Mantel-Haenszel test to control for clustering by clinical center.|Risk Difference (RD)|1.8||||0.9|TWO_SIDED|95.0|-9.0|2.5|||Mantel Haenszel|||Marked or moderate improvement at 12 weeks Absolute Difference in Rates % (95% CI)||2.5|-9.0|0.90
72567610|NCT00103402|144666464|SUPERIORITY||Mean Difference (Net)|-0.5||||0.7|TWO_SIDED|95.0|-2.7|1.5|||t-test, 2 sided|||Total score (0-43) change from baseline||1.5|-2.7|0.70
72567611|NCT00103402|144666464|SUPERIORITY||Mean Difference (Net)|-0.3||||0.64|TWO_SIDED|95.0|-1.4|0.8|||t-test, 2 sided|||Pain score (0-21) change from baseline||0.8|-1.4|0.64
72567612|NCT00103402|144666464|SUPERIORITY||Mean Difference (Net)|-0.2||||0.62|TWO_SIDED|95.0|-0.8|0.4|||t-test, 2 sided|||Urinary score (0-10) change from baseline||0.4|-0.8|0.62
72402618|NCT01480076|144311688|SUPERIORITY_OR_OTHER|||||||0.8999|||||||mixed effect model|||Overall, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline MCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.8999
72402619|NCT01480076|144311688|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Overall, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline MCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
72567613|NCT00103402|144666464|SUPERIORITY||Mean Difference (Net)|0.0||||0.99|TWO_SIDED|95.0|-0.4|0.4|||t-test, 2 sided|||Quality of life score (0-12) change from baseline||0.4|-0.4|.99
72567614|NCT00103402|144666465|SUPERIORITY||Mean Difference (Net)|-0.3||||0.45|TWO_SIDED|95.0|-1.8|1.2|||t-test, 2 sided|||McGill Total Score||1.2|-1.8|0.45
72567615|NCT00103402|144666465|SUPERIORITY||Mean Difference (Net)|-0.2||||0.47|TWO_SIDED|95.0|-1.4|1.0|||t-test, 2 sided|||McGill Sensory Score||1.0|-1.4|0.47
72567616|NCT00103402|144666465|SUPERIORITY||Mean Difference (Net)|-0.1||||0.89|TWO_SIDED|95.0|-0.6|0.4|||t-test, 2 sided|||McGill Affective Score||0.4|-0.6|0.89
72567617|NCT00103402|144666466|SUPERIORITY||Mean Difference (Net)|-0.5||||0.6|TWO_SIDED|95.0|-2.3|1.3|||t-test, 2 sided|||Physical component summary (0-100) change in scores||1.3|-2.3|0.60
72567618|NCT00103402|144666466|SUPERIORITY||Mean Difference (Net)|2.1||||0.16|TWO_SIDED|95.0|-0.4|4.6|||t-test, 2 sided|||Mental component summary (0-100) Absolute Difference between Groups (95% CI)||4.6|-0.4|0.16
72567619|NCT00103402|144666467|SUPERIORITY||Mean Difference (Net)|-1.1||||0.08|TWO_SIDED|95.0|-2.4|0.2|||t-test, 2 sided|||||0.2|-2.4|0.08
72567620|NCT00103402|144666468|SUPERIORITY||Risk Difference (RD)|0.7||||0.94|TWO_SIDED|95.0|-2.6|4.0|||t-test, 2 sided|||||4.0|-2.6|0.94
72567621|NCT00103402|144666469|SUPERIORITY||Mean Difference (Net)|1.1||||0.06|TWO_SIDED|95.0|-0.3|2.5|||t-test, 2 sided|||||2.5|-0.3|0.06
72567622|NCT01583218|144666505|SUPERIORITY||Relative Risk Reduction (RRR)|0.209||||0.038|TWO_SIDED|95.0|0.013|0.366|||Cochran-Mantel-Haenszel|||||0.366|0.013|0.038
72567623|NCT01583218|144666506|SUPERIORITY||Relative Risk Reduction (RRR)|0.216||||0.018|TWO_SIDED|95.0|0.041|0.359|||Cochran-Mantel-Haenszel|||||0.359|0.041|0.018
72567624|NCT01583218|144666507|SUPERIORITY||Relative Risk Reduction (RRR)|0.254||||0.003|TWO_SIDED|95.0|0.092|0.387|||Cochran-Mantel-Haenszel|||||0.387|0.092|0.003
72567625|NCT01583218|144666508|SUPERIORITY|||||||0.554|||||||Chi-squared|||||||0.554
72567626|NCT01583218|144666509|SUPERIORITY||Relative Risk Reduction (RRR)|0.326||||0.092|TWO_SIDED|95.0|-0.069|0.576|||Cochran-Mantel-Haenszel|||||0.576|-0.069|0.092
72567627|NCT01583218|144666510|SUPERIORITY||Relative Risk Reduction (RRR)|0.295||||0.11|TWO_SIDED|95.0|-0.085|0.542|||Cochran-Mantel-Haenszel|||||0.542|-0.085|0.11
72567628|NCT01583218|144666511|SUPERIORITY||Relative Risk Reduction (RRR)|0.358||||0.039|TWO_SIDED|95.0|0.02|0.58|||Cochran-Mantel-Haenszel|||||0.580|0.020|0.039
72567629|NCT00986453|144666512|SUPERIORITY_OR_OTHER|||||||0.4697||95.0|||||t-test, 2 sided|||||||0.4697
72567630|NCT00986453|144666513|SUPERIORITY_OR_OTHER|||||||0.147||95.0|||||t-test, 2 sided|||||||0.1470
72567631|NCT00986453|144666514|SUPERIORITY_OR_OTHER|||||||0.0428||95.0|||||t-test, 2 sided|||||||0.0428
72567632|NCT00986453|144666515|SUPERIORITY_OR_OTHER|||||||0.0776||95.0|||||t-test, 2 sided|||||||0.0776
72567633|NCT00986453|144666516|SUPERIORITY_OR_OTHER|||||||0.0002||95.0|||||t-test, 2 sided|||||||0.0002
72485220|NCT00232141|144497922|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.35||0.7704||95.0|-0.79|0.59||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Punctate hyperalgesia testing area||0.59|-0.79|0.7704
72485221|NCT00232141|144497922|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.17|STANDARD_ERROR_OF_MEAN|0.33||0.6088||95.0|-0.82|0.48||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Temporal summation to tactile stimuli||0.48|-0.82|0.6088
72485222|NCT00232141|144497922|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.29|STANDARD_ERROR_OF_MEAN|0.33||0.3767||95.0|-0.93|0.35||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Cold allodynia testing area||0.35|-0.93|0.3767
72512462|NCT00789191|144555261|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.07||||0.135||95.0|0.8|5.37||No corrections to adjust for multiplicity were performed. Statistical significance threshold was p\<0.05.|Regression, Logistic||Treatment group comparison using logistic regression model incl.treatment,stratification factor, country as fixed effects, baseline HbA1c as covariate|Null hypothesis: Odds ratio is equal to one.||5.37|0.8|0.135
72512463|NCT00789191|144555262|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.28||||0.121||95.0|-0.07|0.63||No corrections to adjust for multiplicity were performed. Statistical significance threshold was p\<0.05.|ANCOVA|An analysis of covariance (ANCOVA) was used; baseline was included as covariate and treatment, stratification and country was included as factors.||||0.63|-0.07|0.121
72512464|NCT00789191|144555263|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.84||||0.109||95.0|-0.19|1.88||No corrections to adjust for multiplicity were performed. Statistical significance threshold was p\<0.05.|ANCOVA|An analysis of covariance (ANCOVA) was used; baseline was included as covariate and treatment, stratification and country was included as factors.||||1.88|-0.19|0.109
72512465|NCT00789191|144555264|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.45||||0.001||95.0|-3.01|-1.88||No corrections to adjust for multiplicity were performed. Statistical significance threshold was p\<0.05.|ANCOVA|An analysis of covariance (ANCOVA) was used; baseline was included as covariate and treatment, stratification and country was included as factors.||||-1.88|-3.01|0.0010
72567634|NCT03182582|144666634|SUPERIORITY|||||||0.003|||||||Paired t test|||A sample size of 22 patients was required to achieve 80% power, using a two-tailed test with α = 0.05.||||0.003
72567635|NCT03334721|144666645|SUPERIORITY|"Given the crossover design through which the data were collected, the statistical model also included a Visit (1 vs. 2) factor and a Visit by Treatment Condition interaction term. Analysis used Linear Mixed Modeling with Fixed Factors."|Test III Tests of Fixed Effects (F)|0.141||||0.711|TWO_SIDED|||||Treatment Condition Factor (0 = Placebo, 1 = Gabapentin)|Mixed Models Analysis|df = 1, 20.183|||"Given the crossover design through which the data were collected, the statistical model also included a Visit (1 vs. 2) factor and a Visit by Treatment Condition interaction term."|||0.711
72567636|NCT02287909|144666649|SUPERIORITY||least square mean difference|-6.9|||>|0.05|TWO_SIDED|985.0|-38.0|24.0|||ANCOVA|||||24|-38|>0.05
72567637|NCT03439852|144666656|SUPERIORITY||Mean Difference (Net)|0.83|||<|0.05|TWO_SIDED|95.0|0.26|1.39|||Mixed Models Analysis|||Multilevel modeling for repeated measures was conducted to compare 2 conditions over time. The model included group, time, and the interaction between group and time, adjusting for within-subject correlation. The response was transformed using squared root to satisfy the model assumption.||1.39|0.26|<0.05
72567638|NCT03439852|144666657|SUPERIORITY||Median Difference (Net)|1.14||||0.05|TWO_SIDED|95.0|-0.37|2.64||Calculated|Mixed Models Analysis|||Multilevel modeling conducted for repeated measures comparing minutes per week of light-to-moderate physical activity for participants in two conditions over time. In the multilevel models, participants were nested within Catholic Clubs, adjusting for within-club and within-subject correlations. The model includes group, time, and the interaction between group and time, adjusting for within-subject correlation. The response was transformed using squared root to satisfy the model assumption.||2.64|-0.37|0.05
72567639|NCT03439852|144666658|SUPERIORITY||Mean Difference (Net)|-0.72||||0.05|TWO_SIDED|95.0|-2.31|0.88|||Mixed Models Analysis|||Multilevel modeling for the repeated measures was conducted comparing the two conditions over time. In the multilevel models, participants were nested within Catholic Clubs, adjusting for within-club and within-subject correlations. The model includes group, time, and the interaction between group and time, adjusting for within-subject correlation. The response was transformed using squared root to satisfy the model assumption.||0.88|-2.31|0.05
72567640|NCT03439852|144666659|SUPERIORITY||Mean Difference (Net)|0.96|||<|0.05|TWO_SIDED|95.0|-2.67|4.6|||Mixed Models Analysis|||Multilevel modeling for the repeated measures was conducted comparing the two conditions over time. In the multilevel models, participants were nested within Catholic Clubs, adjusting for within-club and within-subject correlations. The model includes group, time, and the interaction between group and time, adjusting for within-subject correlation.||4.60|-2.67|<0.05
72567641|NCT03439852|144666660|SUPERIORITY||Mean Difference (Net)|-0.76|||<|0.05|TWO_SIDED|95.0|-1.11|-0.4|||Mixed Models Analysis|||||-0.40|-1.11|<0.05
72567642|NCT03439852|144666661|SUPERIORITY||Mean Difference (Net)|-0.62|||<|0.05|TWO_SIDED|95.0|-1.15|0.1|||Mixed Models Analysis|||||0.10|-1.15|<0.05
72567643|NCT03439852|144666662|SUPERIORITY||Median Difference (Net)|-0.49|||<|0.05|TWO_SIDED|95.0|-2.1|1.11|||Mixed Models Analysis|Repeated measures generalized linear model test effects of time/group, \& interaction rate met MVPA, adjusting for within subject correlation.||||1.11|-2.10|<0.05
72567644|NCT00605865|144666669|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||not adjusted, p=0.050|Chi-squared|||"The risk factor tested was complications. The null hypothesis is there is no difference between with and without complications in the participants of responders."||||<0.001
72567645|NCT00605865|144666670|SUPERIORITY_OR_OTHER_LEGACY|||||||0.039|TWO_SIDED|||||not adjusted, p=0.050|Chi-squared|||"The risk factor tested was concomitant drug. The null hypothesis is there is no difference between with and without concomitant drug in the participants of responders."||||0.039
72402620|NCT01480076|144311688|SUPERIORITY_OR_OTHER|||||||0.7156|||||||mixed effect model|||Overall, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline MCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.7156
72485223|NCT00232141|144497922|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.11|STANDARD_ERROR_OF_MEAN|0.38||0.7689||95.0|-0.64|0.86||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Cold hyperalgesia testing area||0.86|-0.64|0.7689
72485224|NCT00232141|144497923|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.38|STANDARD_ERROR_OF_MEAN|0.25||0.1277||95.0|-0.86|0.11||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||||0.11|-0.86|0.1277
72485225|NCT00232141|144497924|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.36|STANDARD_ERROR_OF_MEAN|0.18||0.0469||95.0|-0.71|0.0||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 1||-0.00|-0.71|0.0469
72485226|NCT00232141|144497924|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.63|STANDARD_ERROR_OF_MEAN|0.23||0.0067||95.0|-1.08|-0.18||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 2||-0.18|-1.08|0.0067
72485227|NCT00232141|144497924|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.58|STANDARD_ERROR_OF_MEAN|0.27||0.031||95.0|-1.1|-0.05||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 3||-0.05|-1.10|0.0310
72567646|NCT00605865|144666671|SUPERIORITY_OR_OTHER_LEGACY|||||||0.011|TWO_SIDED|||||not adjusted, p=0.050|Chi-squared|||"The risk factor tested was renal dysfunction. The null hypothesis is there is no difference between with and without renal dysfunction in the participants of responders."||||0.011
72485228|NCT00232141|144497924|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.34|STANDARD_ERROR_OF_MEAN|0.27||0.2088||95.0|-0.86|0.19||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 4||0.19|-0.86|0.2088
72485229|NCT00232141|144497924|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.35|STANDARD_ERROR_OF_MEAN|0.26||0.1849||95.0|-0.87|0.17||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 5||0.17|-0.87|0.1849
72485230|NCT00232141|144497924|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.55|STANDARD_ERROR_OF_MEAN|0.27||0.0452||95.0|-1.09|-0.01||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 6||-0.01|-1.09|0.0452
72485231|NCT00232141|144497924|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.61|STANDARD_ERROR_OF_MEAN|0.29||0.0359||95.0|-1.18|-0.04||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 7||-0.04|-1.18|0.0359
72485232|NCT00232141|144497924|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.69|STANDARD_ERROR_OF_MEAN|0.29||0.0184||95.0|-1.26|-0.12||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 8||-0.12|-1.26|0.0184
72485233|NCT00232141|144497924|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.48|STANDARD_ERROR_OF_MEAN|0.29||0.1043||95.0|-1.06|0.1||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 9||0.10|-1.06|0.1043
72512466|NCT00789191|144555268|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.01||||||95.0|-2.5|-1.51|||Linear Mixed-model|PG profile analysis:linear mixed effect model.Treatment,time,country,time-by-treatment interaction as explanatory variables.Subject as a random factor|COMB-SITA Difference. Before breakfast|||-1.51|-2.50|
72402621|NCT01480076|144311688|SUPERIORITY_OR_OTHER||difference of LS means|2.9|STANDARD_ERROR_OF_MEAN|1.03||0.005|TWO_SIDED||||||mixed effect model|||Overall, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline MCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0050
72576904|NCT00261443|144680711|SUPERIORITY_OR_OTHER_LEGACY|||||||0.542||95.0|||||Wilcoxon Rank Sum Test|||Lowest Value Treatment Comparison; Aripiprazole/Placebo||||0.542
72485234|NCT00232141|144497924|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.47|STANDARD_ERROR_OF_MEAN|0.29||0.1053||95.0|-1.04|0.1||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 10||0.10|-1.04|0.1053
72402622|NCT01480076|144311688|SUPERIORITY_OR_OTHER||difference of LS means|3.3|STANDARD_ERROR_OF_MEAN|1.68||0.049|TWO_SIDED||||||mixed effect model|||Overall, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline MCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0490
72512467|NCT00789191|144555268|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.64||||||95.0|-2.4|-0.89|||Linear Mixed-model|PG profile analysis:linear mixed effect model.Treatment,time,country,time-by-treatment interaction as explanatory variables.Subject as a random factor|COMB-SITA Difference. 120 minutes after start of breakfast|||-0.89|-2.40|
72512468|NCT00789191|144555268|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.02||||||95.0|-1.69|-0.35|||Linear Mixed-model|PG profile analysis:linear mixed effect model.Treatment,time,country,time-by-treatment interaction as explanatory variables.Subject as a random factor|COMB-SITA Difference. Before lunch|||-0.35|-1.69|
72512469|NCT00789191|144555268|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.3||||||95.0|-2.05|-0.56|||Linear mixed-model|PG profile analysis:linear mixed effect model.Treatment,time,country,time-by-treatment interaction as explanatory variables.Subject as a random factor|COMB-SITA Difference. 120 minutes after start of lunch|||-0.56|-2.05|
72402623|NCT01480076|144311688|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 3, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline MCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
72512470|NCT00789191|144555268|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.77||||||95.0|-1.58|0.05|||Linear Mixed-model|PG profile analysis:linear mixed effect model.Treatment,time,country,time-by-treatment interaction as explanatory variables.Subject as a random factor|COMB-SITA Difference. Before dinner|||0.05|-1.58|
72512471|NCT00789191|144555268|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.88||||||95.0|-1.75|-0.02|||Linear Mixed-model|PG profile analysis:linear mixed effect model.Treatment,time,country,time-by-treatment interaction as explanatory variables.Subject as a random factor|COMB-SITA Difference. 120 minutes after start of dinner|||-0.02|-1.75|
72512472|NCT00789191|144555268|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.04||||||95.0|-1.88|-0.2|||Linear Mixed-model|PG profile analysis:linear mixed effect model.Treatment,time,country,time-by-treatment interaction as explanatory variables.Subject as a random factor|COMB-SITA Difference. Bedtime|||-0.20|-1.88|
72402624|NCT01480076|144311688|SUPERIORITY_OR_OTHER|||||||0.274|||||||mixed effect model|||Month 3, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline MCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.2740
72402625|NCT01480076|144311688|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 3, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline MCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
72512473|NCT00789191|144555268|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.17||||||95.0|-1.84|-0.49|||Linear Mixed Model|PG profile analysis:linear mixed effect model.Treatment,time,country,time-by-treatment interaction as explanatory variables.Subject as a random factor|COMB-SITA Difference. At 03:00 a.m.|||-0.49|-1.84|
72512474|NCT00789191|144555268|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.8||||||95.0|-2.26|-1.34|||Linear Mixed-model|PG profile analysis:linear mixed effect model.Treatment,time,country,time-by-treatment interaction as explanatory variables.Subject as a random factor|COMB-SITA Difference. Before breakfast the following day|||-1.34|-2.26|
72512475|NCT02702518|144555303|OTHER||||||<|0.001||||||p-values were calculated via linear quantile mixed model for continuous variables with missing data.|Mixed Models Analysis|||For the outcome measure corneal staining, data at week 8 was compared with data at baseline to determine if a change was significant (threshold p \< 0.05).||||<0.001
72512476|NCT02702518|144555303|OTHER|||||||0.2324||||||p-values were calculated via linear quantile mixed model for continuous variables with missing data.|Mixed Models Analysis|||For the outcome measure corneal staining data at week 8 was compared with data at baseline to determine significant change.||||0.2324
72512477|NCT02702518|144555304|OTHER|||||||0.001||||||p-values were calculated via linear quantile mixed model for continuous variables.|Mixed Models Analysis|||For the outcome measure OSDI, data at week 8 was compared with data at baseline to determine if a change was significant (threshold p \< 0.05).||||0.001
72512478|NCT02702518|144555304|OTHER|||||||0.2257||||||p-values were calculated via linear quantile mixed model for continuous variables.|Mixed Models Analysis|||For the outcome measure OSDI data at week 8 was compared with data at baseline to determine significant change.||||0.2257
72512479|NCT01000727|144555319|SUPERIORITY||Hazard Ratio (HR)|1.0||||0.929|TWO_SIDED|95.02|0.91|1.09||Statistical significance of this p-value is based on the alpha-spending function of this study.|Cox Proportional Hazard Regression Model|||||1.09|0.91|0.929
72512480|NCT01000727|144555320|SUPERIORITY||Hazard Ratio (HR)|0.99||||0.777|TWO_SIDED|95.02|0.9|1.09||Statistical significance of this p-value is based on the alpha-spending function of this study.|Cox Proportional Hazard Regression Model|||||1.09|0.90|0.777
72512481|NCT01000727|144555321|SUPERIORITY||Hazard Ratio (HR)|0.91||||0.274|TWO_SIDED|95.0|0.76|1.08||Statistical significance of this p-value is based on the alpha-spending function of this study.|Cox Proportional Hazard Regression Model|||||1.08|0.76|0.274
72512482|NCT01000727|144555322|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.631|TWO_SIDED|95.0|0.86|1.09|||Cox Proportional Hazard Regression Model||A hazard ratio \<1 indicates a lower risk with this treatment compared to Placebo|||1.09|0.86|0.631
72512483|NCT01000727|144555323|SUPERIORITY||Hazard Ratio (HR)|1.12||||0.354|TWO_SIDED|95.0|0.88|1.42|||Cox Proportional Hazard Regression Model||A hazard ratio \< 1 indicates a lower risk with this treatment compared to Placebo|||1.42|0.88|0.354
72512484|NCT01000727|144555324|SUPERIORITY||Hazard Ratio (HR)|0.88||||0.161|TWO_SIDED|95.0|0.73|1.05|||Cox Proportional Hazard Regression Model|||||1.05|0.73|0.161
72402626|NCT01480076|144311688|SUPERIORITY_OR_OTHER|||||||0.5556|||||||mixed effect model|||Month 3, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline MCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.5556
72402627|NCT01480076|144311688|SUPERIORITY_OR_OTHER||difference of LS means|5.2|STANDARD_ERROR_OF_MEAN|1.15|<|0.0001|TWO_SIDED||||||mixed effect model|||Month 3, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline MCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
72402628|NCT01480076|144311688|SUPERIORITY_OR_OTHER||difference of LS means|3.7|STANDARD_ERROR_OF_MEAN|1.88||0.0476|TWO_SIDED||||||mixed effect model|||Month 3, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline MCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0476
72402629|NCT01480076|144311688|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 6, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline MCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
72485235|NCT00232141|144497924|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.44|STANDARD_ERROR_OF_MEAN|0.3||0.144||95.0|-1.03|0.15||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 11||0.15|-1.03|0.1440
72485236|NCT00232141|144497924|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.55|STANDARD_ERROR_OF_MEAN|0.32||0.0866||95.0|-1.17|0.08||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 12||0.08|-1.17|0.0866
72485237|NCT00232141|144497924|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.67|STANDARD_ERROR_OF_MEAN|0.32||0.0359||95.0|-1.3|-0.04||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 13||-0.04|-1.30|0.0359
72485238|NCT00232141|144497924|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.62|STANDARD_ERROR_OF_MEAN|0.34||0.0711||95.0|-1.3|0.05||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 14||0.05|-1.30|0.0711
72485239|NCT00232141|144497926|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.43|STANDARD_ERROR_OF_MEAN|0.23||0.0685||95.0|-0.89|0.03||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 1||0.03|-0.89|0.0685
72485240|NCT00232141|144497926|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.03|STANDARD_ERROR_OF_MEAN|0.28||0.928||95.0|-0.52|0.57||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 2||0.57|-0.52|0.9280
72485241|NCT00232141|144497926|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.13|STANDARD_ERROR_OF_MEAN|0.29||0.6672||95.0|-0.71|0.45||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 6||0.45|-0.71|0.6672
72485242|NCT00232141|144497926|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.29||0.9731||95.0|-0.57|0.59||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 10||0.59|-0.57|0.9731
72512485|NCT01000727|144555325|SUPERIORITY||Hazard Ratio (HR)|1.09||||0.36|TWO_SIDED|95.0|0.91|1.31|||Cox Proportional Hazard Regression Model|||||1.31|0.91|0.360
72402630|NCT01480076|144311688|SUPERIORITY_OR_OTHER|||||||0.8627|||||||mixed effect model|||Month 6, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline MCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.8627
72485243|NCT00232141|144497926|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.04|STANDARD_ERROR_OF_MEAN|0.33||0.9045||95.0|-0.61|0.69||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 14||0.69|-0.61|0.9045
72512486|NCT01000727|144555326|SUPERIORITY||Hazard Ratio (HR)|0.95||||0.202|TWO_SIDED|95.0|0.88|1.03|||Cox Proportional Hazard Regression Model||A hazard ratio \<1 indicates a lower risk with this treatment compared to Placebo|||1.03|0.88|0.202
72576905|NCT00261443|144680712|SUPERIORITY_OR_OTHER_LEGACY|||||||0.916||95.0|||||Wilcoxon Rank Sum Test|||Baseline Treatment Comparison; Aripiprazole/Placebo||||0.916
72512487|NCT01000727|144555327|SUPERIORITY||Hazard Ratio (HR)|0.96||||0.329|TWO_SIDED|95.0|0.87|1.05|||Cox Proportional Hazard Regression Model|||||1.05|0.87|0.329
72402631|NCT01480076|144311688|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 6, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline MCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
72402632|NCT01480076|144311688|SUPERIORITY_OR_OTHER|||||||0.4312|||||||mixed effect model|||Month 6, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline MCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.4312
72485244|NCT00232141|144497926|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.07|STANDARD_ERROR_OF_MEAN|0.3||0.8298||95.0|-0.53|0.66||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Endpoint||0.66|-0.53|0.8298
72512488|NCT01000727|144555328|SUPERIORITY||Hazard Ratio (HR)|0.99||||0.797|TWO_SIDED|95.0|0.9|1.08|||Cox Proportional Hazard Regression Model|||||1.08|0.90|0.797
72512489|NCT01000727|144555329|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.546|TWO_SIDED|95.0|0.87|1.07|||Cox Proportional Hazard Regression Model||A hazard ratio \<1 indicates a lower risk with this treatment compared to Placebo|||1.07|0.87|0.546
72512490|NCT01000727|144555330|SUPERIORITY||Hazard Ratio (HR)|0.94||||0.362|TWO_SIDED|95.0|0.81|1.08|||Cox Proportional Hazard Regression Model|||||1.08|0.81|0.362
72512491|NCT02207478|144555331|SUPERIORITY_OR_OTHER|||||||0.019|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.019
72512492|NCT02207478|144555332|SUPERIORITY_OR_OTHER|||||||0.843|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Total procedure time||||0.843
72512493|NCT02207478|144555332|SUPERIORITY_OR_OTHER|||||||0.233|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Total X-ray time||||0.233
72402633|NCT01480076|144311688|SUPERIORITY_OR_OTHER||difference of LS means|2.8|STANDARD_ERROR_OF_MEAN|1.27||0.0305|TWO_SIDED||||||mixed effect model|||Month 6, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline MCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0305
72485245|NCT00232141|144497927|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.04|STANDARD_ERROR_OF_MEAN|0.24||0.8605||95.0|-0.52|0.44||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 1||0.44|-0.52|0.8605
72485246|NCT00232141|144497927|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.06|STANDARD_ERROR_OF_MEAN|0.27||0.8348||95.0|-0.58|0.47||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 2||0.47|-0.58|0.8348
72485247|NCT00232141|144497927|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.32|STANDARD_ERROR_OF_MEAN|0.26||0.2227||95.0|-0.83|0.19||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 6||0.19|-0.83|0.2227
72485248|NCT00232141|144497927|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.19|STANDARD_ERROR_OF_MEAN|0.27||0.4753||95.0|-0.73|0.34||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 10||0.34|-0.73|0.4753
72485249|NCT00232141|144497927|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.14|STANDARD_ERROR_OF_MEAN|0.27||0.6017||95.0|-0.4|0.68||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 14||0.68|-0.40|0.6017
72485250|NCT00232141|144497927|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.13|STANDARD_ERROR_OF_MEAN|0.26||0.6158||95.0|-0.38|0.64||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Endpoint||0.64|-0.38|0.6158
72485251|NCT00232141|144497928|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.26|STANDARD_ERROR_OF_MEAN|0.22||0.239||95.0|-0.69|0.17||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 1||0.17|-0.69|0.2390
72485252|NCT00232141|144497928|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.24||0.9444||95.0|-0.49|0.45||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 2||0.45|-0.49|0.9444
72512494|NCT02207478|144555332|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Duration time for finding lesions||||<0.001
72512495|NCT02207478|144555332|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||X-ray time for finding lesions||||<0.001
72512496|NCT00922194|144555392|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-8.36|STANDARD_DEVIATION|3.3|<|0.05||95.0|-9.03|-7.72|||Paired t test|||Analysis of difference between 12 months or more and baseline values||-7.72|-9.03|<0.05
72512497|NCT00922194|144555393|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-3.27|||<|0.05||95.0|-3.5|-3.0|||Wilcoxon paired signed rank-sum test|||Analysis of difference between 12 months or more and baseline values||-3.0|-3.5|<0.05
72512498|NCT00922194|144555394|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-7.41|||<|0.05||95.0|-8.37|-6.47|||Wilcoxon paired signed rank-sum test|||Analysis of difference between 12 months and baseline values||-6.47|-8.37|<0.05
72512499|NCT00922194|144555395|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.014|||<|0.05||95.0|-0.02|0.001|||Wilcoxon paired sign rank-sum test|||Analysis of difference between 12 months or more and baseline values||0.001|-0.02|<0.05
72512500|NCT00922194|144555396|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-4.61|||<|0.05||95.0|-5.2|-3.8|||Wilcoxon paired signed rank-sum test|||Analysis of difference between 12 months and baseline values||-3.8|-5.2|<0.05
72512501|NCT00922194|144555397|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-2.97|||<|0.05||95.0|-3.57|-2.38|||Wilcoxon paired signed rank-sum test|||Analysis of difference between 12 months and baseline values||-2.38|-3.57|<0.05
72512502|NCT00922194|144555398|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-2.37|||<|0.05||95.0|-2.65|-2.08|||Wilcoxon paired signed rank-sum test|||Analysis of difference between 12 months and baseline values||-2.08|-2.65|<0.05
72512503|NCT01757405|144555401|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Equivalence of treatment success proportions in all bleeding episodes for the two treatment groups was determined by comparing the 90% two-sided CI of the ratio of success proportions to the equivalence region defined as \[0.83, 1.20\].|Ratio of success proportion|1.21|||||TWO_SIDED|90.0|1.15|1.28|||Ratio of success proportion|||Equivalence test of successfully treated bleeding episodes (BEs) between or within treatment arms. Denoting the success rates in the two treatment groups by p1 and p2 , the null hypotheses of H01 : p1/p2 \< 0.83 and H02 : p1/p2 \> 1.20 was implicitly tested against the one-sided alternatives Ha1: 0.83 ≤ p1/p2 and Ha2 : p1/p2 ≤ 1.20, by comparing the 90% two-sided confidence interval (CI) of the ratio of success proportions to the equivalence region defined as \[0.83, 1.20\].||1.28|1.15|
72512504|NCT04507867|144555441|OTHER|Kaplan-Meier method for overall survival.||||||0.027|||||||Log Rank|||The total number of patients who did or did not survive to day 40 of follow-up.||||0.027
72512505|NCT04507867|144555443|OTHER|Kaplan-Meier method||||||0.495|||||||Log Rank|||the total number of patients who were intubated and survived at the end of day 40 follow-up.||||0.495
72512506|NCT04507867|144555445|OTHER|Kaplan-Meier method||||||0.186|||||||Log Rank|||total number of patients included in the study who progressed to mechanical ventilation during the first 10 days of hospital stay.||||0.186
72512507|NCT04507867|144555446|SUPERIORITY|Fisher exact test||||||0.35|||||||Fisher Exact|||Intergroup analysis between the control group and the intervention group, measured at day 3 of hospital stay. It was categorized as follows: 1. normal bristol scale at day 3; 2. abnormal bristol scale at day 3.||||0.35
72512508|NCT04507867|144555447|SUPERIORITY|||||||0.043|||||||t-test, 1 sided|||Intergroup analysis between the control group and the intervention group, measured at day 3 of hospital stay . Deceased patients were excluded.||||0.043
72567647|NCT00605865|144666672|SUPERIORITY_OR_OTHER_LEGACY|||||||0.01|TWO_SIDED|||||not adjusted, p=0.050|Chi-squared|||"The risk factor tested was past medical history of other illness. The null hypothesis is there is no difference between with and without past medical history of other illness in the participants of responders."||||0.010
72567648|NCT00605865|144666673|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||not adjusted, p=0.050|Chi-squared|||"The risk factor tested was average daily dose. The null hypothesis is there is no difference of five types of average daily dose in the participants of responders."||||<0.001
72567649|NCT00605865|144666674|SUPERIORITY_OR_OTHER_LEGACY|||||||0.014|TWO_SIDED|||||not adjusted, p=0.050|Chi-squared|||"The risk factor tested was suicidal ideation (including suicide attempt). The null hypothesis is there is no difference between with and without suicidal ideation(including suicide attempt) in the participants of responders."||||0.014
72512509|NCT04507867|144555448|SUPERIORITY|||||||0.241|||||||Fisher Exact|||Intergroup analysis between the control group and the intervention group for different parameters, measured at day 3 of hospital stay . Deceased patients were excluded.||||0.241
72512510|NCT04507867|144555449|SUPERIORITY|||||||0.187|||||||t-test, 2 sided|||Intragroup analysis at the control group, the measurement was performed at baseline and at hospital discharge.||||0.187
72512511|NCT04507867|144555449|SUPERIORITY|||||||0.003|||||||t-test, 2 sided|||Intragroup analysis at the intervention group, the measurement was performed at baseline and at hospital discharge.||||0.003
72512512|NCT04507867|144555450|SUPERIORITY|||||||0.919|||||||t-test, 2 sided|||Intragroup analysis of the control group in oxygen delivery, the difference between the baseline period and day 3 of hospital stay.||||0.919
72567650|NCT00605865|144666675|SUPERIORITY_OR_OTHER_LEGACY|||||||0.021|TWO_SIDED|||||not adjusted, p=0.050|Chi-squared|||"The risk factor tested was 15 years and higher of age or not. The null hypothesis is there is no difference between 15 years and higher of age or not in the participants of responders."||||0.021
72567651|NCT00605865|144666676|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||not adjusted, p=0.050|Chi-squared|||"The factor tested was target disease severity. The null hypothesis is there is no difference between three grade of target disease severity in the participants of responders."||||<0.001
72512513|NCT04507867|144555450|SUPERIORITY|||||||0.014|||||||t-test, 2 sided|||Intragroup analysis of the control group in oxygen delivery, the difference between the baseline period and day 3 of hospital stay.||||0.014
72512514|NCT04507867|144555451|SUPERIORITY|||||||0.608|||||||Wilcoxon (Mann-Whitney)|||Intragroup analysis of the control group, the difference in the qSOFA measurement at baseline and at day 3 will be analyzed.||||0.608
72512515|NCT04507867|144555451|SUPERIORITY|||||||0.04|||||||t-test, 2 sided|||Intragroup analysis of the intervention group, the difference in the qSOFA measurement at baseline and at day 3 will be analyzed.||||0.04
72512516|NCT04507867|144555452|SUPERIORITY|||||||0.014|||||||Wilcoxon (Mann-Whitney)|||Intergroup analysis between both groups to evaluate the number of defecations measured at day 3.||||0.014
72567652|NCT00605865|144666677|SUPERIORITY_OR_OTHER_LEGACY|||||||0.003|TWO_SIDED|||||not adjusted, p=0.050|Chi-squared|||"The factor tested was history of treatment prior to Sertralin. The null hypothesis is there is no difference between with and without history of treatment prior to Sertralin in the participants of responders."||||0.003
72576906|NCT00261443|144680712|SUPERIORITY_OR_OTHER_LEGACY|||||||0.707||95.0|||||Wilcoxon Rank Sum Test|||Week 52 LOCF Treatment Comparison; Aripiprazole/Placebo||||0.707
72512517|NCT04507867|144555453|SUPERIORITY|||||||0.008|||||||Fisher Exact|the shapiro wilk test was used to analyze the distribution of the data.||Intergroup analysis between the control group and the intervention group for different parameters, measured at day 3 of hospital stay. Deceased patients were excluded.||||0.008
72512518|NCT04507867|144555455|SUPERIORITY|Intergroup analysis between the control group and the intervention group for different parameters, measured at a complete follow-up of 40 days. Deceased patients were excluded.||||||0.078|||||||Fisher Exact|||||||0.078
72512519|NCT04507867|144555456|SUPERIORITY|||||||0.098|||||||t-test, 1 sided|||Intergroup analysis between the control group and the intervention group for different parameters, measured at a complete follow-up of 40 days. Deceased patients were excluded||||0.098
72512520|NCT04507867|144555457|OTHER|||||||0.195|||||||Fisher Exact|||Intergroup analysis between the control group and the intervention group to analyze the presentation of post covid syndrome at the end of follow-up at day 40.||||0.195
72512521|NCT04507867|144555458|SUPERIORITY|||||||0.135|||||||Fisher Exact|||Intergroup analysis between the control group and the intervention group for different parameters, measured at a complete follow-up of 40 days. Deceased patients were excluded.||||0.135
72512522|NCT04507867|144555459|SUPERIORITY|||||||0.266|||||||Fisher Exact|||Intergroup analysis between the control group and the intervention group for different parameters, measured at a complete follow-up of 40 days. Deceased patients were excluded.||||0.266
72512523|NCT04507867|144555460|SUPERIORITY|Association between the presentation of certain laboratory parameters taken in the baseline period, with te overall mortality of discharge patients in comparison with deceased patients||||||0.002|||||||Fisher Exact|||||||0.002
72512524|NCT04507867|144555461|SUPERIORITY|Association between the presentation of certain laboratory parameters taken in the baseline period, with te overall mortality of discharge patients in comparison with deceased patients||||||0.003|||||||Fisher Exact|||||||0.003
72512525|NCT04507867|144555462|SUPERIORITY|Association between the presentation of certain laboratory parameters taken in the baseline period, with te overall mortality of discharge patients in comparison with deceased patients||||||0.004|||||||Fisher Exact|||||||0.004
72512526|NCT04507867|144555463|SUPERIORITY|Association between the presentation of certain laboratory parameters taken in the baseline period, with te overall mortality of discharge patients in comparison with deceased patients||||||0.011|||||||Fisher Exact|||||||0.011
72512527|NCT04507867|144555464|SUPERIORITY|Association between the presentation of certain laboratory parameters taken in the baseline period, with te overall mortality of discharge patients in comparison with deceased patients||||||0.031|||||||Fisher Exact|||||||0.031
72512528|NCT04507867|144555465|SUPERIORITY|Association between the presentation of certain laboratory parameters taken in the baseline period, with te overall mortality of discharge patients in comparison with deceased patients||||||0.04|||||||Fisher Exact|||||||0.040
72512529|NCT04507867|144555466|SUPERIORITY|Association between the presentation of certain laboratory parameters taken in the baseline period, with te overall mortality of discharge patients in comparison with deceased patients||||||0.047|||||||Fisher Exact|||||||0.047
72512530|NCT04124536|144555467|SUPERIORITY||Risk Difference (RD)|-21.9|||||TWO_SIDED|95.0|-35.9|-7.9|||||The risk difference was calculated by subtracting the proportion of women meeting the outcome in the intervention arm minus the proportion of women meeting the outcome in the control arm|||-7.9|-35.9|
72512531|NCT04124536|144555467|SUPERIORITY||Risk Difference (RD)|-30.7|||||TWO_SIDED|95.0|-40.6|-20.8|||||The risk difference was calculated by subtracting the proportion of women meeting the outcome in the intervention arm minus the proportion of women meeting the outcome in the control arm|||-20.8|-40.6|
72512532|NCT04124536|144555468|SUPERIORITY||Risk Difference (RD)|-5.4|||||TWO_SIDED|95.0|-13.6|2.8|||||The risk difference was calculated by subtracting the proportion of women meeting the outcome in the intervention arm minus the proportion of women meeting the outcome in the control arm|||2.8|-13.6|
72512533|NCT04124536|144555468|SUPERIORITY||||||||||||||||||The calculation of risk differences between study arms was originally planned. However, the linear-binomial model did not converge because of zero events in the intervention arm.|||
72512534|NCT04124536|144555472|SUPERIORITY||Risk Difference (RD)|40.7|||||TWO_SIDED|95.0|23.0|58.4|||||The risk difference was calculated by subtracting the proportion of women meeting the outcome in the intervention arm minus the proportion of women meeting the outcome in the control arm|||58.4|23.0|
72512535|NCT04124536|144555472|SUPERIORITY||Risk Difference (RD)|23.3|||||TWO_SIDED|95.0|10.7|36.0|||||The risk difference was calculated by subtracting the proportion of women meeting the outcome in the intervention arm minus the proportion of women meeting the outcome in the control arm|||36.0|10.7|
72512536|NCT00677690|144555483|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||t-test, 1 sided|||"All data were expressed as the mean ± SD. The level of significance for all tests was set at p \< 0.05.~Inter- and intra-group comparisons were performed using both paired and unpaired t tests for continuous variables and Chi squared for categorical variables."||||< 0.05
72512537|NCT00677690|144555484|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||t-test, 1 sided|||||||<0.05
72512538|NCT00677690|144555485|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||t-test, 1 sided|||||||<0.05
72512539|NCT00677690|144555486|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||t-test, 1 sided|||||||<0.05
72512540|NCT00677690|144555487|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||t-test, 1 sided|||||||<0.05
72512541|NCT01106625|144555500|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-0.71|STANDARD_ERROR_OF_MEAN|0.097|<|0.001|TWO_SIDED|95.0|-0.904|-0.524|||ANCOVA|||||-0.524|-0.904|<0.001
72512542|NCT01106625|144555500|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-0.92|STANDARD_ERROR_OF_MEAN|0.097|<|0.001|TWO_SIDED|95.0|-1.114|-0.732|||ANCOVA|||||-0.732|-1.114|<0.001
72512543|NCT01106625|144555501|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.42|||<|0.001|TWO_SIDED|95.0|2.48|7.87|||Regression, Logistic|||||7.87|2.48|<0.001
72512544|NCT01106625|144555501|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|8.8|||<|0.001|TWO_SIDED|95.0|4.86|15.95|||Regression, Logistic|||||15.95|4.86|<0.001
72512545|NCT01106625|144555502|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-22.3|STANDARD_ERROR_OF_MEAN|4.627|<|0.001|TWO_SIDED|95.0|-31.53|-13.16|||ANCOVA|||||-13.16|-31.53|<0.001
72512546|NCT01106625|144555502|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-34.6|STANDARD_ERROR_OF_MEAN|4.692|<|0.001|TWO_SIDED|95.0|-43.86|-25.42|||ANCOVA|||||-25.42|-43.86|<0.001
72512547|NCT01106625|144555503|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-1.4|STANDARD_ERROR_OF_MEAN|0.4|<|0.001|TWO_SIDED|95.0|-2.1|-0.7|||ANCOVA|||||-0.7|-2.1|<0.001
72512548|NCT01106625|144555503|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-2.0|STANDARD_ERROR_OF_MEAN|0.4|<|0.001|TWO_SIDED|95.0|-2.7|-1.3|||ANCOVA|||||-1.3|-2.7|<0.001
72512549|NCT01106625|144555504|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-2.24|STANDARD_ERROR_OF_MEAN|1.262||0.077|TWO_SIDED|95.0|-4.719|0.241|||ANCOVA|||||0.241|-4.719|0.077
72512550|NCT01106625|144555504|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-1.62|STANDARD_ERROR_OF_MEAN|1.266||0.201|TWO_SIDED|95.0|-4.111|0.866|||ANCOVA|||||0.866|-4.111|0.201
72512551|NCT01106625|144555505|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-6.2|STANDARD_ERROR_OF_MEAN|5.4||0.256|TWO_SIDED|95.0|-16.9|4.5|||ANCOVA|||||4.5|-16.9|0.256
72512552|NCT01106625|144555505|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-3.1|STANDARD_ERROR_OF_MEAN|5.5||0.571|TWO_SIDED|95.0|-13.8|7.6|||ANCOVA|||||7.6|-13.8|0.571
72512553|NCT01106625|144555506|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|2.5|STANDARD_ERROR_OF_MEAN|1.7||0.153|TWO_SIDED|95.0|-0.9|5.9|||ANCOVA|||||5.9|-0.9|0.153
72512554|NCT01106625|144555506|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|3.4|STANDARD_ERROR_OF_MEAN|1.8||0.056|TWO_SIDED|95.0|-0.1|6.8|||ANCOVA|||||6.8|-0.1|0.056
72512555|NCT01088438|144555512|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|1 degree of freedom||Null hypothesis: proportion of encounters with contextual red flag in which appropriate treatment is planned is the same in the two groups.||||<0.001
72512556|NCT01088438|144555513|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|1 degree of freedom||Null hypothesis is equal proportion of contextual red flags probed in control and intervention groups.||||<.001
72512557|NCT01088438|144555514|SUPERIORITY_OR_OTHER|||||||0.85||95.0|||||Chi-squared|1 df||Null hypothesis is equal proportion of encounters probed in control and intervention groups.||||0.85
72512558|NCT00511342|144555517|SUPERIORITY_OR_OTHER_LEGACY||Difference of adjusted means|-0.078||||0.19|TWO_SIDED|95.0|-0.198|0.041||No corrections for multiple comparisons were made for these safety parameters. The a-priori threshold for statistical significance was 0.05.|ANCOVA|The ANCOVA included the Z-score values at baseline as adjusted factor.|NOMAC-E2 minus LNG-EE for lumbar spine (L2-L4)|||0.041|-0.198|0.19
72512559|NCT00511342|144555517|SUPERIORITY_OR_OTHER_LEGACY||Difference of adjusted means|-0.03||||0.57|TWO_SIDED|95.0|-0.136|0.075||No corrections for multiple comparisons were made for these safety parameters. The a-priori threshold for statistical significance was 0.05.|ANCOVA|The ANCOVA included the Z-score values at baseline as adjusted factor.|NOMAC-E2 minus LNG-EE for femoral neck|||0.075|-0.136|0.57
72512560|NCT01496430|144555531|SUPERIORITY_OR_OTHER|||||||0.007||||||Sequential testing was used to control for multiple comparisons. Azilsartan medoxomil 80 mg was first compared to placebo and if p-value ≤0.05 then azilsartaon medoxomil 40 mg was compared to placebo.|ANCOVA|||||||0.007
72512561|NCT01496430|144555531|SUPERIORITY_OR_OTHER|||||||0.067||||||Sequential testing was used to control for multiple comparisons. Azilsartan medoxomil 80 mg was first compared to placebo and if p-value ≤0.05 then azilsartaon medoxomil 40 mg was compared to placebo.|ANCOVA|||||||0.067
72512562|NCT01496430|144555532|SUPERIORITY_OR_OTHER|||||||0.86||||||Sequential testing was used to control for multiple comparisons. Azilsartan medoxomil 80 mg was first compared to placebo and if p-value ≤0.05 then azilsartaon medoxomil 40 mg was compared to placebo.|ANCOVA|||||||0.860
72512563|NCT01496430|144555532|SUPERIORITY_OR_OTHER|||||||0.21||||||Sequential testing was used to control for multiple comparisons. Azilsartan medoxomil 80 mg was first compared to placebo and if p-value ≤0.05 then azilsartaon medoxomil 40 mg was compared to placebo.|ANCOVA|||||||0.210
72512564|NCT02512068|144555560|SUPERIORITY||Least square (LS) mean difference|-0.72|STANDARD_ERROR_OF_MEAN|0.124|<|0.0001|TWO_SIDED|95.0|-0.966|-0.473|||ANCOVA|||||-0.473|-0.966|<0.0001
72512565|NCT02512068|144555563|OTHER||Point estimate|-0.28|||||TWO_SIDED|95.0|-0.385|-0.18||||||Change from baseline in HbA1c at Week 2 was compared between the treatment groups.||-0.180|-0.385|
72512566|NCT02512068|144555563|OTHER||Point estimate|-0.48|||||TWO_SIDED|95.0|-0.621|-0.338||||||Change from baseline in HbA1c at Week 4 was compared between the treatment groups.||-0.338|-0.621|
72512567|NCT02512068|144555563|OTHER||Point estimate|-0.58|||||TWO_SIDED|95.0|-0.797|-0.367||||||Change from baseline in HbA1c at Week 8 was compared between the treatment groups.||-0.367|-0.797|
72512568|NCT02512068|144555563|OTHER||Point estimate|-0.71|||||TWO_SIDED|95.0|-0.975|-0.441||||||Change from baseline in HbA1c at Week 12 was compared between the treatment groups.||-0.441|-0.975|
72512569|NCT02512068|144555563|OTHER||Point estimate|-0.7|||||TWO_SIDED|95.0|-0.948|-0.452||||||Change from baseline in HbA1c at End of Treatment Period I was compared between the treatment groups.||-0.452|-0.948|
72512570|NCT02512068|144555564|OTHER||Point estimate|1.7|||||TWO_SIDED|95.0|-6.598|9.919||||||The data of participants achieving \<6.0% at the end of Treatment Period I were compared between the treatment groups.||9.919|-6.598|
72512571|NCT02512068|144555564|OTHER||Point estimate|32.9|||||TWO_SIDED|95.0|14.194|51.66||||||The data of participants achieving \<7.0% at the end of Treatment Period I were compared between the treatment groups.||51.660|14.194|
72512572|NCT02512068|144555564|OTHER||Point estimate|45.6|||||TWO_SIDED|95.0|15.528|75.7||||||The data of participants achieving \<8.0% at the end of Treatment Period I were compared between the treatment groups.||75.700|15.528|
72512573|NCT02512068|144555565|OTHER||Point estimate|-15.2|||||TWO_SIDED|95.0|-23.59|-6.88||||||Change from baseline in fasting plasma glucose at Week 2 was compared between the treatment groups.||-6.88|-23.59|
72512574|NCT02512068|144555565|OTHER||Point estimate|-8.7|||||TWO_SIDED|95.0|-20.98|3.58||||||Change from baseline in fasting plasma glucose at Week 4 was compared between the treatment groups.||3.58|-20.98|
72512575|NCT02512068|144555565|OTHER||Point estimate|-8.3|||||TWO_SIDED|95.0|-18.76|2.11||||||Change from baseline in fasting plasma glucose at Week 8 was compared between the treatment groups.||2.11|-18.76|
72512576|NCT02512068|144555565|OTHER||Point estimate|-15.6|||||TWO_SIDED|95.0|-27.14|-4.03||||||Change from baseline in fasting plasma glucose at Week 12 was compared between the treatment groups.||-4.03|-27.14|
72512577|NCT02512068|144555565|OTHER||Point estimate|-15.6|||||TWO_SIDED|95.0|-26.67|-4.62||||||Change from baseline in fasting plasma glucose at End of Treatment Period I was compared between the treatment groups.||-4.62|-26.67|
72512578|NCT02512068|144555566|OTHER||Point estimate|-1.76|||||TWO_SIDED|95.0|-2.184|-1.34||||||Change from baseline in glycoalbumin at Week 2 was compared between the treatment groups.||-1.340|-2.184|
72512579|NCT02512068|144555566|OTHER||Point estimate|-2.45||||||95.0|-3.03|-1.87||||||Change from baseline in glycoalbumin at Week 4 was compared between the treatment groups.||-1.870|-3.030|
72402634|NCT01480076|144311688|SUPERIORITY_OR_OTHER||difference of LS means|2.6|STANDARD_ERROR_OF_MEAN|2.03||0.2059|TWO_SIDED||||||mixed effect model|||Month 6, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline MCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.2059
72567653|NCT00605865|144666678|SUPERIORITY_OR_OTHER_LEGACY|||||||0.012|TWO_SIDED|||||not adjusted, p=0.050|Chi-squared|||"The factor tested was outpatient or inpatient. The null hypothesis is there is no difference between outpatient or inpatient in the participants of responders."||||0.012
72402635|NCT01480076|144311688|SUPERIORITY_OR_OTHER|||||||0.0008|||||||mixed effect model|||Month 9, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline MCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0008
72485253|NCT00232141|144497928|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.09|STANDARD_ERROR_OF_MEAN|0.27||0.7386||95.0|-0.63|0.45||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 6||0.45|-0.63|0.7386
72485254|NCT00232141|144497928|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.25|STANDARD_ERROR_OF_MEAN|0.27||0.3493||95.0|-0.79|0.28||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 10||0.28|-0.79|0.3493
72485255|NCT00232141|144497928|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.13|STANDARD_ERROR_OF_MEAN|0.3||0.6596||95.0|-0.46|0.73||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 14||0.73|-0.46|0.6596
72485256|NCT00232141|144497928|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.23|STANDARD_ERROR_OF_MEAN|0.27||0.4075||95.0|-0.31|0.77||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Endpoint||0.77|-0.31|0.4075
72485257|NCT00232141|144497929|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.55|STANDARD_ERROR_OF_MEAN|0.23||0.0202||95.0|-1.01|-0.09||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 1||-0.09|-1.01|0.0202
72485258|NCT00232141|144497929|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.04|STANDARD_ERROR_OF_MEAN|0.26||0.8865||95.0|-0.55|0.47||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 2||0.47|-0.55|0.8865
72485259|NCT00232141|144497929|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.27||0.9964||95.0|-0.54|0.54||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 6||0.54|-0.54|0.9964
72485260|NCT00232141|144497929|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.15|STANDARD_ERROR_OF_MEAN|0.28||0.5993||95.0|-0.7|0.41||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 10||0.41|-0.70|0.5993
72485261|NCT00232141|144497929|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.29|STANDARD_ERROR_OF_MEAN|0.31||0.3553||95.0|-0.33|0.9||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 14||0.90|-0.33|0.3553
72485262|NCT00232141|144497929|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.31|STANDARD_ERROR_OF_MEAN|0.29||0.2771||95.0|-0.25|0.88||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Endpoint||0.88|-0.25|0.2771
72485263|NCT00232141|144497930|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.31|STANDARD_ERROR_OF_MEAN|0.26||0.2352||95.0|-0.82|0.2||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 1||0.20|-0.82|0.2352
72485264|NCT00232141|144497930|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.08|STANDARD_ERROR_OF_MEAN|0.26||0.7607||95.0|-0.6|0.44||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 2||0.44|-0.60|0.7607
72485265|NCT00232141|144497930|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.12|STANDARD_ERROR_OF_MEAN|0.27||0.6563||95.0|-0.64|0.4||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 6||0.40|-0.64|0.6563
72624100|NCT01892189|144778533|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.218|STANDARD_ERROR_OF_MEAN|0.20968||0.306|TWO_SIDED|95.0|-0.6441|0.2081|||ANOVA||Difference between least square means of TAK-063 30 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Left Anterior Cingulate Cortex: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.2081|-0.6441|0.306
72485266|NCT00232141|144497930|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.06|STANDARD_ERROR_OF_MEAN|0.27||0.8319||95.0|-0.58|0.47||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 10||0.47|-0.58|0.8319
72485267|NCT00232141|144497930|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.3|STANDARD_ERROR_OF_MEAN|0.3||0.3086||95.0|-0.28|0.89||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 14||0.89|-0.28|0.3086
72485268|NCT00232141|144497930|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.07|STANDARD_ERROR_OF_MEAN|0.28||0.7972||95.0|-0.48|0.62||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Endpoint||0.62|-0.48|0.7972
72485269|NCT00232141|144497931|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.38|STANDARD_ERROR_OF_MEAN|0.28||0.1863||95.0|-0.94|0.18||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 1||0.18|-0.94|0.1863
72485270|NCT00232141|144497931|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.16|STANDARD_ERROR_OF_MEAN|-0.31||0.5953||95.0|-0.77|0.44||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 2||0.44|-0.77|0.5953
72485271|NCT00232141|144497931|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.18|STANDARD_ERROR_OF_MEAN|0.28||0.508||95.0|-0.73|0.36||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 6||0.36|-0.73|0.5080
72485272|NCT00232141|144497931|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.15|STANDARD_ERROR_OF_MEAN|0.28||0.5842||95.0|-0.7|0.39||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 10||0.39|-0.70|0.5842
72485273|NCT00232141|144497931|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.24|STANDARD_ERROR_OF_MEAN|0.3||0.4286||95.0|-0.35|0.83||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 14||0.83|-0.35|0.4286
72485274|NCT00232141|144497931|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.16|STANDARD_ERROR_OF_MEAN|0.28||0.5766||95.0|-0.4|0.71||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Endpoint||0.71|-0.40|0.5766
72485275|NCT00232141|144497932|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.17|STANDARD_ERROR_OF_MEAN|0.28||0.5493||95.0|-0.73|0.39||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 1||0.39|-0.73|0.5493
72485276|NCT00232141|144497932|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.3||0.9875||95.0|-0.58|0.59||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 2||0.59|-0.58|0.9875
72512580|NCT02512068|144555566|OTHER||Point estimate|-2.48|||||TWO_SIDED|95.0|-3.289|-1.679||||||Change from baseline in glycoalbumin at Week 8 was compared between the treatment groups.||-1.679|-3.289|
72512581|NCT02512068|144555566|OTHER||Point estimate|-2.66|||||TWO_SIDED|95.0|-3.608|-1.715||||||Change from baseline in glycoalbumin at Week 12 was compared between the treatment groups.||-1.715|-3.608|
72512582|NCT02512068|144555566|OTHER||Point estimate|-2.66|||||TWO_SIDED|95.0|-3.608|-1.715||||||Change from baseline in glycoalbumin at End of Treatment Period I was compared between the treatment groups.||-1.715|-3.608|
72512583|NCT01962714|144555583|NON_INFERIORITY|The primary outcome of non-inferiority of LKM relative to CPT-C was assessed using a non-inferiority margin of 5 points on the CAPS-5, which represents 0.5 SD of baseline PTSD symptoms based on data indicating the SD of baseline CAPS-5 scores is approximately 10 in a large sample (N=198) of treatment-seeking veterans.|Mean Difference (Final Values)|2.09|||||TWO_SIDED|95.0|-2.59|6.78|||||Non-inferiority of LKM to CPT-C was analyzed as the change rate from baseline to 6-month follow-up between groups (CPT-C minus LKM), with a positive value indicating a greater reduction in scores for LKM compared to CPT-C.|The non-inferiority of LKM with respect to CPT-C was analyzed using the 95% confidence interval for the group x time interaction term, with non-inferiority of LKM to CPT-C claimed if the lower limit of the 95% confidence interval was greater than (i.e., did not extend beyond) negative delta.||6.78|-2.59|
72485277|NCT00232141|144497932|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.11|STANDARD_ERROR_OF_MEAN|0.29||0.6931||95.0|-0.68|0.45||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 6||0.45|-0.68|0.6931
72485278|NCT00232141|144497932|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|0.28||0.4614||95.0|-0.34|0.75||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 10||0.75|-0.34|0.4614
72485279|NCT00232141|144497932|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.45|STANDARD_ERROR_OF_MEAN|0.31||0.1467||95.0|-0.16|1.06||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 14||1.06|-0.16|0.1467
72485280|NCT00232141|144497932|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.31|STANDARD_ERROR_OF_MEAN|0.29||0.2819||95.0|-0.25|0.87||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Endpoint||0.87|-0.25|0.2819
72485281|NCT00232141|144497933|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.04|STANDARD_ERROR_OF_MEAN|0.26||0.8727||95.0|-0.55|0.46||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 1||0.46|-0.55|0.8727
72485282|NCT00232141|144497933|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.11|STANDARD_ERROR_OF_MEAN|0.28||0.6897||95.0|-0.65|0.43||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 2||0.43|-0.65|0.6897
72485283|NCT00232141|144497933|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.08|STANDARD_ERROR_OF_MEAN|0.26||0.7527||95.0|-0.6|0.44||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 6||0.44|-0.60|0.7527
72485284|NCT00232141|144497933|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.13|STANDARD_ERROR_OF_MEAN|0.28||0.6394||95.0|-0.67|0.41||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 10||0.41|-0.67|0.6394
72512584|NCT01962714|144555584|NON_INFERIORITY|For depression, the non-inferiority margin was 4 points on the PROMIS depression measure, which has been defined as the minimally important difference and corresponds to a Cohen's d effect size of approximately 0.50.|Mean Difference (Final Values)|2.34|||||TWO_SIDED|95.0|-0.52|5.2|||||Non-inferiority of LKM with respect to CPT-C was analyzed as the change rate from baseline to 6-month follow-up between groups (CPT-C minus LKM), with a positive value indicating a greater reduction in scores from baseline for LKM compared to CPT-C.|The non-inferiority of LKM with respect to CPT-C was analyzed using the 95% confidence interval for the group x time interaction term, with non-inferiority of LKM to CPT-C claimed if the lower limit of the 95% confidence interval was greater than (i.e., did not extend beyond) negative delta.||5.20|-0.52|
72485285|NCT00232141|144497933|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.49|STANDARD_ERROR_OF_MEAN|0.31||0.1188||95.0|-0.13|1.11||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 14||1.11|-0.13|0.1188
72485286|NCT00232141|144497933|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.31|STANDARD_ERROR_OF_MEAN|0.28||0.2685||95.0|-0.24|0.87||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Endpoint||0.87|-0.24|0.2685
72485287|NCT00232141|144497934|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.19|STANDARD_ERROR_OF_MEAN|0.28||0.4991||95.0|-0.74|0.36||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 1||0.36|-0.74|0.4991
72485288|NCT00232141|144497934|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.15|STANDARD_ERROR_OF_MEAN|0.3||0.6094||95.0|-0.73|0.43||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 2||0.43|-0.73|0.6094
72512585|NCT02458690|144555585|SUPERIORITY|||||||0.6|||||||ANCOVA|ANCOVA models adjusted for the stratification variables of age group and sex||||||0.60
72485289|NCT00232141|144497934|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.24|STANDARD_ERROR_OF_MEAN|0.26||0.3669||95.0|-0.76|0.28||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 6||0.28|-0.76|0.3669
72512586|NCT02458690|144555586|SUPERIORITY||||||<|0.01|||||||ANCOVA|ANCOVA models adjusted for the stratification variables of age group and sex||||||<0.01
72512587|NCT02458690|144555587|SUPERIORITY|||||||0.81|||||||ANCOVA|ANCOVA models adjusted for the stratification variables of age group and sex||||||0.81
72624101|NCT01892189|144778533|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2525|STANDARD_ERROR_OF_MEAN|0.17956||0.169|TWO_SIDED|95.0|-0.6174|0.1124|||ANOVA||Difference between least square means of TAK-063 3 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Right Anterior Cingulate Cortex: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.1124|-0.6174|0.169
72624102|NCT01892189|144778533|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.0417|STANDARD_ERROR_OF_MEAN|0.19375||0.831|TWO_SIDED|95.0|-0.4354|0.3521|||ANOVA||Difference between least square means of TAK-063 10 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Right Anterior Cingulate Cortex: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.3521|-0.4354|0.831
72402636|NCT01480076|144311688|SUPERIORITY_OR_OTHER|||||||0.3685|||||||mixed effect model|||Month 9, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline MCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.3685
72485290|NCT00232141|144497934|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.08|STANDARD_ERROR_OF_MEAN|0.26||0.7641||95.0|-0.43|0.59||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 10||0.59|-0.43|0.7641
72485291|NCT00232141|144497934|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.27||0.9428||95.0|-0.51|0.55||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 14||0.55|-0.51|0.9428
72485292|NCT00232141|144497934|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.26||0.9508||95.0|-0.52|0.49||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Endpoint||0.49|-0.52|0.9508
72485293|NCT00232141|144497935|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.68|STANDARD_ERROR_OF_MEAN|0.25||0.0073||95.0|-1.18|-0.19||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 1||-0.19|-1.18|0.0073
72485294|NCT00232141|144497935|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.37|STANDARD_ERROR_OF_MEAN|0.3||0.2202||95.0|-0.96|0.22||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 2||0.22|-0.96|0.2202
72485295|NCT00232141|144497935|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.39|STANDARD_ERROR_OF_MEAN|0.29||0.1824||95.0|-0.95|0.18||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 6||0.18|-0.95|0.1824
72512588|NCT02458690|144555588|SUPERIORITY|||||||0.2|||||||ANCOVA|ANCOVA models adjusted for the stratification variables of age group and sex||||||0.20
72512589|NCT02458690|144555589|SUPERIORITY|||||||0.09|||||||ANCOVA|ANCOVA models adjusted for the stratification variables of age group and sex||||||0.09
72512590|NCT02458690|144555590|SUPERIORITY|||||||0.23|||||||ANCOVA|ANCOVA models adjusted for the stratification variables of age group and sex||||||0.23
72512591|NCT02458690|144555591|SUPERIORITY|||||||0.09|||||||ANCOVA|ANCOVA models adjusted for the stratification variables of age group and sex||||||0.09
72512592|NCT01151579|144555592|NON_INFERIORITY_OR_EQUIVALENCE|A total of at least 400 treatemnts or 65 patients was required to achieve 94% power to determine a 1% change by treatment or a 5% change between groups to be significant at p-value of 0.01 and o.05, respectively.|Mean Difference (Final Values)|1.0|STANDARD_ERROR_OF_MEAN|0.5||0.01|TWO_SIDED|95.0|||||Mixed Models Analysis|||Null Hypothesis: No difference between groups in heart rate changes from baseline following treatment. Sample size calculation determined a need for at least 400 breathing treatments among 65 patients.||||0.01
72512593|NCT01151579|144555593|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.0||||0.05|TWO_SIDED|95.0||||Analysis adjusted with Fischer exact chi-square for rare occurrences.|Chi-squared|||Null hypothesis: no difference in incidence of arrhythmias between groups within the total number of breathing treatments.||||0.05
72512594|NCT01151579|144555594|SUPERIORITY_OR_OTHER|||||||0|TWO_SIDED||||||descriptive|Descriptive statistics (frequency) used to report the number of participants experiencing an event.||To report on the number of events.||||0
72512595|NCT03615469|144555595|OTHER|t-test||||||0.22|||||||t-test, 2 sided|||||||0.22
72512596|NCT01153763|144555596|OTHER||percentage of participants|59.0|||||TWO_SIDED|95.0|48.2|70.3|||||The estimated value represents the percentage of participants with a confirmed CR or a confirmed PR.|||70.3|48.2|
72512597|NCT01153763|144555597|OTHER||percentage of participants|13.0|||||TWO_SIDED|95.0|0.0|28.7|||||The estimated value represents the percentage of participants with a investigator assessed CR or PR.|||28.7|0.0|
72512598|NCT01153763|144555602|OTHER||percentage of participants|20.0|||||TWO_SIDED|95.0|11.6|29.8|||||The estimated value represents the percentage of participants with overall survival.|||29.8|11.6|
72512599|NCT01153763|144555603|OTHER||percentage of participants|13.0|||||TWO_SIDED|95.0|2.2|34.6|||||The estimated value represents the percentage of participants with overall survival.|||34.6|2.2|
72512600|NCT00369668|144555675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|30.0|STANDARD_ERROR_OF_MEAN|3.65|<|0.05|TWO_SIDED|95.0|22.5|37.4|||Mixed Models Analysis|Greenhouse-Geisser degrees of freedom adjustment was not necessary.||Group by Test Session ANOVA with repeated measures on second factor.||37.4|22.5|<0.05
72402637|NCT01480076|144311688|SUPERIORITY_OR_OTHER|||||||0.0016|||||||mixed effect model|||Month 9, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline MCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0016
72485296|NCT00232141|144497935|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.39|STANDARD_ERROR_OF_MEAN|0.3||0.1872||95.0|-0.98|0.19||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 10||0.19|-0.98|0.1872
72485297|NCT00232141|144497935|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.25|STANDARD_ERROR_OF_MEAN|0.32||0.4374||95.0|-0.38|0.88||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 14||0.88|-0.38|0.4374
72485298|NCT00232141|144497935|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.23|STANDARD_ERROR_OF_MEAN|0.3||0.4406||95.0|-0.36|0.82||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Endpoint||0.82|-0.36|0.4406
72485299|NCT00232141|144497936|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.33|STANDARD_ERROR_OF_MEAN|0.27||0.2277||95.0|-0.86|0.21||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 1||0.21|-0.86|0.2277
72485300|NCT00232141|144497936|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.07|STANDARD_ERROR_OF_MEAN|0.33||0.8407||95.0|-0.71|0.58||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 2||0.58|-0.71|0.8407
72485301|NCT00232141|144497936|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.04|STANDARD_ERROR_OF_MEAN|0.29||0.8809||95.0|-0.62|0.53||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 6||0.53|-0.62|0.8809
72485302|NCT00232141|144497936|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.14|STANDARD_ERROR_OF_MEAN|0.29||0.6288||95.0|-0.72|0.43||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 10||0.43|-0.72|0.6288
72485303|NCT00232141|144497936|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.3||0.9739||95.0|-0.59|0.61||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 14||0.61|-0.59|0.9739
72485304|NCT00232141|144497936|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.04|STANDARD_ERROR_OF_MEAN|0.29||0.8926||95.0|-0.61|0.53||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Endpoint||0.53|-0.61|0.8926
72485305|NCT00232141|144497939|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7136||95.0||||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|Cochran-Mantel-Haenszel|||||||0.7136
72512601|NCT00516269|144555740|SUPERIORITY_OR_OTHER||mean difference in treat versus control|0.42|STANDARD_DEVIATION|3.3||0.54||95.0|||||Wilcoxon signed rank test|||As a crossover study, the potential carryover effect was examined first. The pooled data (the 2-week treatment for each intervention i.e. period 1 \& period 2) was used to assess the treatment effect (A versus B).||||0.54
72485306|NCT00232141|144497940|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6729||95.0||||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|Cochran-Mantel-Haenszel|||||||0.6729
72485307|NCT00782288|144497944|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Measures were compared between Baseline, Treatment \& Recovery periods to determine if changes from baseline differed between placebo and the two digitoxin dose levels. Kruskal-Wallis equity of population rank test was performed on the changes Day 28 minus Day 1. To compare the change from baseline to treatment period between the two arms, a Wilcoxon rank sum test was performed. To determine whether induced sputum Il-8 returned to baseline at the final visit, a one sample sign test was performed.||||>0.05
72512602|NCT01552928|144555752|SUPERIORITY_OR_OTHER_LEGACY|||||||0.004|||||||ANCOVA|||||||0.004
72512603|NCT01552928|144555752|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||ANCOVA|||||||<0.001
72485308|NCT00782288|144497950|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Baseline,Treatment and Recovery periods were compared to determine if changes from baseline differed between placebo and the two digitoxin doses.||||>0.05
72512604|NCT01552928|144555752|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||ANCOVA|||||||<0.001
72512605|NCT01552928|144555753|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||ANCOVA|||||||<0.001
72512606|NCT01552928|144555753|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||ANCOVA|||||||<0.001
72512607|NCT01552928|144555753|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|||||||ANCOVA|||||||0.001
72512608|NCT01552928|144555754|SUPERIORITY_OR_OTHER_LEGACY|||||||0.012|||||||ANCOVA|||||||0.012
72512609|NCT01552928|144555754|SUPERIORITY_OR_OTHER_LEGACY|||||||0.044|||||||ANCOVA|||||||0.044
72402638|NCT01480076|144311688|SUPERIORITY_OR_OTHER|||||||0.9862|||||||mixed effect model|||Month 9, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline MCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.9862
72485309|NCT01479829|144497957|SUPERIORITY||Chi-square value|5.3466||||0.02|TWO_SIDED||||||Chi-squared||The chi-square value with 1 degree of freedom was 5.3466.|The null hypothesis is that there is no difference in the response rate between patients assigned to the intervention cohort or control cohort.||||.02
72485310|NCT01479829|144497958|SUPERIORITY||Chi-square value|13.3821|||<|0.001|TWO_SIDED||||||Chi-squared||The chi-square value with 1 degree of freedom was 13.3821.|The null hypothesis is that there is no difference in the remission rate between patients assigned to the intervention cohort or control cohort.||||<.001
72485311|NCT00601250|144497959|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.64|STANDARD_ERROR_OF_MEAN|0.07|<|0.0001|TWO_SIDED|95.0|-0.78|-0.5|||ANCOVA|||Linagliptin vs. Placebo||-0.5|-0.78|<0.0001
72485312|NCT00601250|144497960|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.431|STANDARD_ERROR_OF_MEAN|0.05|<|0.0001|TWO_SIDED|95.0|-0.53|-0.333|||ANCOVA|||Linagliptin vs. Placebo||-0.333|-0.530|<0.0001
72485313|NCT00601250|144497961|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.596|STANDARD_ERROR_OF_MEAN|0.064|<|0.0001||95.0|-0.721|-0.471|||ANCOVA|||Linagliptin vs. Placebo||-0.471|-0.721|<0.0001
72485314|NCT00601250|144497962|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.648|STANDARD_ERROR_OF_MEAN|0.069|<|0.0001||95.0|-0.785|-0.512|||ANCOVA|||Linagliptin vs. Placebo||-0.512|-0.785|<0.0001
72512610|NCT01552928|144555754|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||ANCOVA|||||||<0.001
72512611|NCT01552928|144555755|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||ANCOVA|||||||<0.001
72512612|NCT01552928|144555755|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||ANCOVA|||||||<0.001
72512613|NCT01552928|144555755|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||ANCOVA|||||||<0.001
72512614|NCT01552928|144555756|SUPERIORITY_OR_OTHER_LEGACY|||||||0.003|||||||ANCOVA|||||||0.003
72512615|NCT01552928|144555756|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||ANCOVA|||||||<0.001
72512616|NCT01552928|144555756|SUPERIORITY_OR_OTHER_LEGACY|||||||0.043|||||||ANCOVA|||||||0.043
72512617|NCT01552928|144555761|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||ANCOVA|||||||<0.001
72512618|NCT01552928|144555761|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||ANCOVA|||||||<0.001
72567654|NCT00605865|144666679|SUPERIORITY_OR_OTHER_LEGACY|||||||0.019|TWO_SIDED|||||not adjusted, p=0.050|Chi-squared|||"The factor tested was complications. The null hypothesis is there is no difference between with or without complications in the participants of responders."||||0.019
72567655|NCT00605865|144666680|SUPERIORITY_OR_OTHER_LEGACY|||||||0.01|TWO_SIDED|||||not adjusted, p=0.050|Chi-squared|||"The factor tested was 15 years and higher of age or not. The null hypothesis is there is no difference between 15 years and higher of age or not in the participants of responders."||||0.010
72567656|NCT00605865|144666681|SUPERIORITY_OR_OTHER_LEGACY|||||||0.015|TWO_SIDED|||||not adjusted, p=0.050|Chi-squared|||"The factor tested was age. The null hypothesis is there is no difference between four groups of age in the participants of responders."||||0.015
72485315|NCT00601250|144497963|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-21.13|STANDARD_ERROR_OF_MEAN|3.14|<|0.0001||95.0|-27.3|-14.96|||ANCOVA|||Linagliptin vs. Placebo||-14.96|-27.3|<0.0001
72485316|NCT00601250|144497964|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-16.52|STANDARD_ERROR_OF_MEAN|2.67|<|0.0001||95.0|-21.76|-11.29|||ANCOVA|||Linagliptin vs. Placebo||-11.29|-21.76|<0.0001
72485317|NCT00601250|144497965|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-16.73|STANDARD_ERROR_OF_MEAN|2.91|<|0.0001||95.0|-22.44|-11.01|||ANCOVA|||Linagliptin vs. Placebo||-11.01|-22.44|<0.0001
72485318|NCT00601250|144497966|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-20.83|STANDARD_ERROR_OF_MEAN|3.05|<|0.0001||95.0|-26.81|-14.84|||ANCOVA|||Linagliptin vs. Placebo||-14.84|-26.81|<0.0001
72512619|NCT01552928|144555761|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||ANCOVA|||||||<0.001
72512620|NCT01552928|144555762|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||ANCOVA|||||||<0.001
72512621|NCT01552928|144555762|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||ANCOVA|||||||<0.001
72512622|NCT01552928|144555762|SUPERIORITY_OR_OTHER_LEGACY|||||||0.004|||||||ANCOVA|||||||0.004
72512623|NCT01552928|144555763|SUPERIORITY_OR_OTHER_LEGACY|||||||0.005|||||||ANCOVA|||||||0.005
72512624|NCT01552928|144555763|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||ANCOVA|||||||<0.001
72512625|NCT01552928|144555763|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||ANCOVA|||||||<0.001
72512626|NCT01552928|144555764|SUPERIORITY_OR_OTHER_LEGACY|||||||0.078|||||||ANCOVA|||||||0.078
72512627|NCT01552928|144555764|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||ANCOVA|||||||<0.001
72512628|NCT01552928|144555764|SUPERIORITY_OR_OTHER_LEGACY|||||||0.156|||||||ANCOVA|||||||0.156
72512629|NCT01552928|144555765|SUPERIORITY_OR_OTHER_LEGACY|||||||0.439|||||||ANCOVA|||||||0.439
72512630|NCT01552928|144555765|SUPERIORITY_OR_OTHER_LEGACY|||||||0.274|||||||ANCOVA|||||||0.274
72512631|NCT01552928|144555765|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||ANCOVA|||||||<0.001
72512632|NCT04030104|144555766|SUPERIORITY|||||||0.0268||||||Threshold for statistical significance \<0.05|Random Reader, Random Mass|Curve Fitting Method: Empirical||||||0.0268
72512633|NCT01079962|144555770|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.701||||0.5943|TWO_SIDED|95.0|-1.89|3.29||No adjustment of p-value was done and priori threshold was 0.05.|t-test, 2 sided|||Change in APP at Week 12: p-value was calculated by 2 sided t-test.||3.29|-1.89|0.5943
72512634|NCT01079962|144555771|SUPERIORITY_OR_OTHER|||||||0.8589||95.0|||||t-test, 2 sided|||Change in SBP at Week 4: p-value was calculated by 2 sided t-test.||||0.8589
72576907|NCT00261443|144680712|SUPERIORITY_OR_OTHER_LEGACY|||||||0.665||95.0|||||Wilcoxon Rank Sum Test|||Highest Value Treatment Comparison; Aripiprazole/Placebo||||0.665
72512635|NCT01079962|144555771|SUPERIORITY_OR_OTHER|||||||0.2223||95.0|||||t-test, 2 sided|||Change in SBP at Week 12: p-value was calculated by 2 sided t-test.||||0.2223
72485319|NCT00601250|144497967|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.395|||<|0.0001||95.0|2.41|8.013|||Regression, Logistic|||"Linagliptin vs. Placebo~The odds-ratio is based on a logistic regression model including baseline HbA1c and previous antidiabetic medication."||8.013|2.410|<0.0001
72485320|NCT00601250|144497969|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.456||||0.0016||95.0|1.907|15.614|||Regression, Logistic|||"Linagliptin vs. Placebo~The odds-ratio is based on a logistic regression model including baseline HbA1c and previous antidiabetic medication."||15.614|1.907|0.0016
72485321|NCT00601250|144497971|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.754|||<|0.0001||95.0|2.486|5.669|||Regression, Logistic|||"Linagliptin vs. Placebo~The odds-ratio is based on a logistic regression model including baseline HbA1c and previous antidiabetic medication."||5.669|2.486|<0.0001
72485322|NCT00601250|144497972|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-67.13|STANDARD_ERROR_OF_MEAN|13.88|<|0.0001|TWO_SIDED|95.0|-94.69|-39.58|||ANCOVA|||Linagliptin vs. Placebo||-39.58|-94.69|<0.0001
72485323|NCT00601250|144497973|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-41.8|STANDARD_ERROR_OF_MEAN|10.02|<|0.0001|TWO_SIDED|95.0|-61.71|-21.89|||ANCOVA|||Linagliptin vs. Placebo||-21.89|-61.71|<0.0001
72512636|NCT01079962|144555771|SUPERIORITY_OR_OTHER|||||||0.2443||95.0|||||t-test, 2 sided|||Change in DBP at Week 4: p-value was calculated by 2 sided t-test.||||0.2443
72512637|NCT01079962|144555771|SUPERIORITY_OR_OTHER|||||||0.1481||95.0|||||t-test, 2 sided|||Change in DBP at Week 12: p-value was calculated by 2 sided t-test.||||0.1481
72512638|NCT01079962|144555771|SUPERIORITY_OR_OTHER|||||||0.4188||95.0|||||t-test, 2 sided|||Change in mean BP at Week 4: p-value was calculated by 2 sided t-test.||||0.4188
72512639|NCT01079962|144555771|SUPERIORITY_OR_OTHER|||||||0.1586||95.0|||||t-test, 2 sided|||Change in mean BP at Week 12: p-value was calculated by 2 sided t-test.||||0.1586
72512640|NCT01079962|144555772|SUPERIORITY_OR_OTHER|||||||0.2987||95.0|||||t-test, 2 sided|||Change in AIx at Week 4: p-value was calculated by 2 sided t-test.||||0.2987
72512641|NCT01079962|144555772|SUPERIORITY_OR_OTHER|||||||0.6584||95.0|||||t-test, 2 sided|||Change in AIx at Week 12: p-value was calculated by 2 sided t-test.||||0.6584
72512642|NCT01079962|144555773|SUPERIORITY_OR_OTHER|||||||0.2511||95.0|||||t-test, 2 sided|||Change in cfPWV at Week 4: p-value was calculated by 2 sided t-test.||||0.2511
72576908|NCT00261443|144680712|SUPERIORITY_OR_OTHER_LEGACY|||||||0.757||95.0|||||Wilcoxon Rank Sum Test|||Lowest Value Treatment Comparison; Aripiprazole/Placebo||||0.757
72512643|NCT01079962|144555773|SUPERIORITY_OR_OTHER|||||||0.5007||95.0|||||t-test, 2 sided|||Change in cfPWV at Week 12: p-value was calculated by 2 sided t-test.||||0.5007
72512644|NCT01079962|144555774|SUPERIORITY_OR_OTHER|||||||0.9943||95.0|||||t-test, 2 sided|||Change in heart rate at Week 4: p-value was calculated by 2 sided t-test.||||0.9943
72512645|NCT01079962|144555774|SUPERIORITY_OR_OTHER|||||||0.523||95.0|||||t-test, 2 sided|||Change in heart rate at Week 12: p-value was calculated by 2 sided t-test.||||0.5230
72485324|NCT01791803|144497974|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|2.6|||||TWO_SIDED|95.0|1.1|11.4||||||||11.4|1.1|
72485325|NCT01791803|144497974|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|2.4|||||TWO_SIDED|95.0|1.04|9.7||||||||9.7|1.04|
72485326|NCT01791803|144497975|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|2.0|||||TWO_SIDED|95.0|0.8|6.2||||Adjusted for gender, marital status, diagnosis at enrollment.||||6.2|0.8|
72485327|NCT01791803|144497975|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|2.3|||||TWO_SIDED|95.0|1.2|10.0||||||||10|1.2|
72485328|NCT01791803|144497976|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA|||Comparison of smoking status at 12 weeks after hospitalization for a cardiac or pulmonary diagnosis||||< 0.001
72485329|NCT01791803|144497976|SUPERIORITY_OR_OTHER|||||||0.07|||||||ANOVA|||Comparison of smoking stars at 26 weeks after hospitalization for a cardiac or a pulmonary illness||||0.07
72485330|NCT01920594|144498003|SUPERIORITY||Mean Difference (Final Values)|2228.14||||0.082|TWO_SIDED|95.0|-292.84|4749.11|||ANCOVA||The point estimate was calculated as least square (LS) mean difference (final values) of S-100B Protein \[test\] and S-100B Protein \[reference\].|||4749.11|-292.84|0.0820
72485331|NCT01920594|144498004|SUPERIORITY||Mean Difference (Final Values)|777.95||||0.1997|TWO_SIDED|95.0|-424.04|1979.94|||ANCOVA||The point estimate was calculated as LS mean difference (final values) of GFAP \[test\] and GFAP \[reference\].|||1979.94|-424.04|0.1997
72485332|NCT01920594|144498010|SUPERIORITY||Estimate of comparison (Ratio)|1.77||||0.153|TWO_SIDED|95.0|0.8|3.9|||ANOVA||The point estimate was calculated as Geometric mean ratio of S-100B\[test\] and S-100B\[reference\].|||3.90|0.80|0.1530
72485333|NCT01920594|144498011|SUPERIORITY||Estimate of comparison (Ratio)|3.13||||0.1377|TWO_SIDED|95.0|0.69|14.26|||ANOVA||The point estimate was calculated as Geometric mean ratio of GFAP\[test\] and GFAP\[reference\].|||14.26|0.69|0.1377
72485334|NCT01920594|144498012|SUPERIORITY||Mean Difference (Final Values)|34.56|||<|0.0001|TWO_SIDED|95.0|21.95|47.17|||ANCOVA||The point estimate was calculated as LS mean difference final values of Erythropoietin\[test\] and Erythropoietin\[reference\].|||47.17|21.95|<.0001
72485335|NCT01920594|144498013|SUPERIORITY||Mean Difference (Final Values)|0.54||||0.2404|TWO_SIDED|95.0|-0.37|1.45|||ANCOVA||The point estimate was calculated as LS mean difference final values of Lactate Dehydrogenase\[test\] and Lactate Dehydrogenase\[reference\].|||1.45|-0.37|0.2404
72485336|NCT01920594|144498014|SUPERIORITY||Mean Difference (Final Values)|925.88||||0.0526|TWO_SIDED|95.0|-10.73|1862.49|||ANCOVA||The point estimate was calculated as LS mean difference final values of Tau Protein\[test\] and Tau Protein\[reference\].|||1862.49|-10.73|0.0526
72485337|NCT01920594|144498015|SUPERIORITY||Mean Difference (Final Values)|4.11||||0.0893|TWO_SIDED|95.0|-0.65|8.87|||ANCOVA||The point estimate was calculated as LS mean difference final values of Neuron Specific Enolase\[test\] and Neuron Specific Enolase\[reference\].|||8.87|-0.65|0.0893
72485338|NCT01920594|144498020|SUPERIORITY||Ratio of geometric mean|1.84||||0.5012|TWO_SIDED|95.0|0.3|11.32|||ANOVA|||For Troponin I||11.32|0.30|0.5012
72485339|NCT01920594|144498020|SUPERIORITY||Ratio of geometric mean|0.75||||0.8053|TWO_SIDED|95.0|0.07|8.57|||ANOVA|||For Troponin T||8.57|0.07|0.8053
72485340|NCT02615470|144498030|SUPERIORITY||||||=|0.202||||||A priori alpha = 0.05|Wilcoxon (Mann-Whitney)|||||||=0.202
72485341|NCT02615470|144498031|SUPERIORITY|||||||0.048|||||||Wilcoxon (Mann-Whitney)|||||||0.048
72485342|NCT02615470|144498032|SUPERIORITY||||||=|0.322||||||a priori alpha = 0.05|Wilcoxon (Mann-Whitney)|||||||=0.322
72485343|NCT01817907|144498034|SUPERIORITY_OR_OTHER|||||||0.52|||||||t-test, 2 sided|||||||0.52
72485344|NCT00785044|144498057|SUPERIORITY_OR_OTHER|Analysis was performed using the null hypothesis for the AUC stated as: H0: θ ≤A versus H1: θ \>A, where the AUC (θ) value was: 'A' selected based on the diagnostic utility desired from the use of myocardial 123 I-mIBG uptake measured using H/M ratio. A smooth parametric model of the ROC curve was fitted to the data. The AUC for the resulting model was calculated and 95% confidence interval for the AUC was reported. The hypothesis was tested using the Z-statistics at 'A' at level of 0.70.|Mean|0.581|||<|0.001|TWO_SIDED|95.0|0.532|0.63||At 0.05 level of significance.|Z-statistic|||"Analysis was performed on all HF participants from both groups AdreView™ - HF Group (With No Adverse Cardiac Events) and AdreView™ - HF Group (With Adverse Cardiac Events) based on H/M ratio."||0.630|0.532|<0.001
72485345|NCT01830855|144498059|SUPERIORITY_OR_OTHER||Ratio of GMTs|1.03|||||TWO_SIDED|95.0|0.93|1.14||||||PMB80 \[A22\]: The lot consistency criteria was achieved if the 95% CI for all pairwise GMRs between lots are within (0.5, 2), for the strain PMB80.||1.14|0.93|
72485346|NCT01830855|144498059|SUPERIORITY_OR_OTHER||Ratio of GMTs|1.02|||||TWO_SIDED|95.0|0.92|1.13||||||PMB80 \[A22\]: The lot consistency criteria was achieved if the 95% CI for all pairwise GMRs between lots are within (0.5, 2), for the strain PMB80.||1.13|0.92|
72485347|NCT01830855|144498059|SUPERIORITY_OR_OTHER||Ratio of GMTs|0.99|||||TWO_SIDED|95.0|0.88|1.12||||||PMB80 \[A22\]: The lot consistency criteria was achieved if the 95% CI for all pairwise GMRs between lots are within (0.5, 2), for the strain PMB80.||1.12|0.88|
72485348|NCT01830855|144498059|SUPERIORITY_OR_OTHER||Ratio of GMTs|0.95|||||TWO_SIDED|95.0|0.85|1.06||||||PMB2948 \[B24\]: The lot consistency criteria was achieved if the 95% CI for all pairwise GMRs between lots are within (0.5, 2), for the strain PMB2948.||1.06|0.85|
72485349|NCT01830855|144498059|SUPERIORITY_OR_OTHER||Ratio of GMTs|0.95|||||TWO_SIDED|95.0|0.86|1.06||||||PMB2948 \[B24\]: The lot consistency criteria was achieved if the 95% CI for all pairwise GMRs between lots are within (0.5, 2), for the strain PMB2948.||1.06|0.86|
72485350|NCT01830855|144498059|SUPERIORITY_OR_OTHER||Ratio of GMTs|1.0|||||TWO_SIDED|95.0|0.88|1.14||||||PMB2948 \[B24\]: The lot consistency criteria was achieved if the 95% CI for all pairwise GMRs between lots are within (0.5, 2), for the strain PMB2948||1.14|0.88|
72485351|NCT03523728|144498114|SUPERIORITY||Relative difference|21.32|||=|0.1367|TWO_SIDED|95.0|-5.77|58.22|||linear mixed effect model|||||58.22|-5.77|=0.1367
72485352|NCT03523728|144498114|SUPERIORITY||Relative difference|0.34|||=|0.9812|TWO_SIDED|95.0|-24.57|33.36|||linear mixed effect model|||||33.36|-24.57|=0.9812
72624103|NCT01892189|144778533|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2421|STANDARD_ERROR_OF_MEAN|0.18403||0.197|TWO_SIDED|95.0|-0.6161|0.1319|||ANOVA||Difference between least square means of TAK-063 30 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Right Anterior Cingulate Cortex: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.1319|-0.6161|0.197
72624104|NCT01892189|144778533|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1155|STANDARD_ERROR_OF_MEAN|0.1618||0.48|TWO_SIDED|95.0|-0.4443|0.2133|||ANOVA||Difference between least square means of TAK-063 3 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Left Posterior Cingulate Cortex: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.2133|-0.4443|0.480
72485353|NCT03523728|144498115|SUPERIORITY||Relative difference|101.32|||=|0.0005|TWO_SIDED|95.0|35.63|233.72|||linear mixed effect model|||||233.72|35.63|=0.0005
72512646|NCT01079962|144555775|SUPERIORITY_OR_OTHER|||||||0.4447||95.0|||||t-test, 2 sided|||||||0.4447
72512647|NCT01079962|144555776|SUPERIORITY_OR_OTHER|||||||0.396||95.0|||||t-test, 2 sided|||Change in Total cholesterol at Week 12: p-value was calculated by 2 sided t-test.||||0.3960
72512648|NCT01079962|144555776|SUPERIORITY_OR_OTHER|||||||0.1919||95.0|||||t-test, 2 sided|||Change in LDL-cholesterol at Week 12: p-value was calculated by 2 sided t-test.||||0.1919
72512649|NCT01079962|144555776|SUPERIORITY_OR_OTHER|||||||0.1896||95.0|||||t-test, 2 sided|||Change in HDL-cholesterol at Week 12: p-value was calculated by 2 sided t-test.||||0.1896
72512650|NCT01079962|144555777|SUPERIORITY_OR_OTHER|||||||0.9244||95.0|||||t-test, 2 sided|||||||0.9244
72512651|NCT01079962|144555778|SUPERIORITY_OR_OTHER|||||||0.9692||95.0|||||t-test, 2 sided|||Change in SBP at Week 4: p-value was calculated by 2 sided t-test.||||0.9692
72485354|NCT03523728|144498115|SUPERIORITY||Relative difference|104.17|||=|0.0002|TWO_SIDED|95.0|39.54|236.45|||linear mixed effect model|||||236.45|39.54|=0.0002
72485355|NCT03523728|144498116|SUPERIORITY||Relative difference|51.01|||=|0.0197|TWO_SIDED|95.0|7.01|125.45|||linear mixed effect model|||||125.45|7.01|=0.0197
72485356|NCT03523728|144498116|SUPERIORITY||Relative difference|46.36|||=|0.0337|TWO_SIDED|95.0|3.21|119.01|||linear mixed effect model|||||119.01|3.21|=0.0337
72485357|NCT03523728|144498118|SUPERIORITY||Least square mean difference|0.11|STANDARD_ERROR_OF_MEAN|0.23|=|0.6374|TWO_SIDED|95.0|-0.342|0.556|||Mixed effect model with repeated measure|||||0.556|-0.342|=0.6374
72485358|NCT03523728|144498118|SUPERIORITY||Least square mean difference|-0.25|STANDARD_ERROR_OF_MEAN|0.22|=|0.256|TWO_SIDED|95.0|-0.689|0.185|||Mixed effect model with repeated measure|||||0.185|-0.689|=0.2560
72485359|NCT03523728|144498119|SUPERIORITY||Least square mean difference|-0.11|STANDARD_ERROR_OF_MEAN|0.42|=|0.79|TWO_SIDED|95.0|-0.971|0.747|||Mixed effect model with repeated measure|||||0.747|-0.971|=0.7900
72485360|NCT03523728|144498119|SUPERIORITY||Least square mean difference|-0.15|STANDARD_ERROR_OF_MEAN|0.32|=|0.6322|TWO_SIDED|95.0|-0.808|0.5|||Mixed effect model with repeated measure|||||0.500|-0.808|=0.6322
72485361|NCT03523728|144498120|SUPERIORITY||Least square mean difference|0.17|STANDARD_ERROR_OF_MEAN|0.34|=|0.6245|TWO_SIDED|95.0|-0.506|0.839|||Mixed effect model with repeated measure|||||0.839|-0.506|=0.6245
72485362|NCT03523728|144498120|SUPERIORITY||Least square mean difference|-0.38|STANDARD_ERROR_OF_MEAN|0.33|=|0.2567|TWO_SIDED|95.0|-1.044|0.281|||Mixed effect model with repeated measure|||||0.281|-1.044|=0.2567
72512652|NCT01079962|144555778|SUPERIORITY_OR_OTHER|||||||0.4731||95.0|||||t-test, 2 sided|||Change in SBP at Week 12: p-value was calculated by 2 sided t-test.||||0.4731
72512653|NCT01079962|144555778|SUPERIORITY_OR_OTHER|||||||0.2876||95.0|||||t-test, 2 sided|||Change in DBP at Week 4: p-value was calculated by 2 sided t-test.||||0.2876
72512654|NCT01079962|144555778|SUPERIORITY_OR_OTHER|||||||0.042||95.0|||||t-test, 2 sided|||Change in DBP at Week 12: p-value was calculated by 2 sided t-test.||||0.0420
72485363|NCT03523728|144498121|SUPERIORITY||Least square mean difference|-0.87|STANDARD_ERROR_OF_MEAN|0.68|=|0.2023|TWO_SIDED|95.0|-2.232|0.485|||Mixed effect model with repeated measure|||||0.485|-2.232|=0.2023
72485364|NCT03523728|144498121|SUPERIORITY||Least square mean difference|-0.54|STANDARD_ERROR_OF_MEAN|0.53|=|0.3205|TWO_SIDED|95.0|-1.61|0.537|||Mixed effect model with repeated measure|||||0.537|-1.610|=0.3205
72485365|NCT00621751|144498134|OTHER||Median Difference (Final Values)|36.7||||0.6|TWO_SIDED|||||CBZ (up to 800 mg daily) vs placebo significantly improves behavior (Rasch NPI irritability \& aggression rated by observer) baseline to day-42 among individuals \>6 months post-traumatic brain injury and moderate-severe irritability.|ANCOVA|||The primary outcome was a composite measure of observer-rated NPI-I \& NPI-A domains transformed to a Rasch logit scale ranging 0 (best) to 100 (worse) units (i.e., observer-rated NPI-I/A Rasch construct scores). Mean day-42 observer-rated NPI-I/A Rasch construct scores were compared between the placebo vs. carbamazepine groups using ANCOVA with baseline score as covariate.||||0.60
72512655|NCT01079962|144555778|SUPERIORITY_OR_OTHER|||||||0.51||95.0|||||t-test, 2 sided|||Change in mean BP at Week 4: p-value was calculated by 2 sided t-test.||||0.5100
72512656|NCT01079962|144555778|SUPERIORITY_OR_OTHER|||||||0.1207||95.0|||||t-test, 2 sided|||Change in mean BP at Week 12: p-value was calculated by 2 sided t-test.||||0.1207
72512657|NCT01079962|144555780|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.442||||0.7561||95.0|-2.36|3.24||No adjustment of p-value was done and priori threshold was 0.05.|t-test, 2 sided|||||3.24|-2.36|0.7561
72512658|NCT01008995|144555821|SUPERIORITY_OR_OTHER||||||<|0.001||||||The study was designed to maintain a Type I error of 0.05 or less for the primary analysis.|Cochran-Mantel-Haenszel|Stratified by baseline weight \[≤ 65kg vs \> 65 kg)\].||Null Hypothesis: No difference between ustekinumab 45 mg and placebo for the primary endpoint at a significance level of 0.05. Power calculations were based on two sample size assumptions: 220 (1:1 ratio) and 320 participants (1:1 ratio). Simulation studies evaluated the power to detect a treatment difference between ustekinumab 45 mg group and placebo using a CMH test stratified by baseline weight \[\<=65 kg vs \> 65 kg). The power was \>99% for both sample size assumptions.||||<0.001
72512659|NCT01008995|144555822|SUPERIORITY_OR_OTHER||||||<|0.001||||||No multiplicity adjustment was made and nominal p-value was reported.|Cochran-Mantel-Haenszel|Stratified by baseline weight \[≤ 65kg vs \> 65 kg)\].||Null Hypothesis: No difference between ustekinumab 45 mg and placebo at a significance level of 0.05.||||<0.001
72512660|NCT01008995|144555823|SUPERIORITY_OR_OTHER||||||<|0.001||||||No multiplicity adjustment was made and nominal p-value was reported.|ANOVA|Analysis of variance on van der Waerden normal scores (Conover, 1980) with treatment and baseline weight (≤ 65kg vs \> 65 kg) as factors in the model.||Null Hypothesis: No difference between ustekinumab 45 mg and placebo at a significance level of 0.05.||||<0.001
72512661|NCT02604810|144555824|NON_INFERIORITY|Method of estimation = least-squares means based on analysis of variance (ANOVA) with a mixed-effect model. The lower bound of the 90% confidence interval (CI) for the geometric LSM ratio (SC/IV) of the primary PK endpoint of steady state AUC0-7 days for the PK population should be above 0.80.|Geometric least-squares mean ratio|1.04|||||TWO_SIDED|90.0|1.0|1.07||||||||1.07|1.00|
72512662|NCT02625324|144555827|SUPERIORITY||Event Rate|0.023|||<|0.0001|ONE_SIDED|97.5||0.081|||Exact binomial test|||"The primary study endpoint, major device effect at 30 days, is a dichotomous study outcome; hence, an exact method based on the binomial distribution was used for the hypothesis testing. The primary study endpoint was tested against a performance goal of 16%:~H0: p ≥ 16% vs. Ha: p \<16%, where p denotes the true event rate of primary study endpoint in the target population."||0.081||<0.0001
72512663|NCT03534063|144555838|SUPERIORITY|||||||0.047|||||||Wilcoxon (Mann-Whitney)|Comparisons for opioid consumption and composite pain intensity were performed by analysis of covariance, adjusting for baseline differences in groups||||||.047
72512664|NCT03534063|144555839|SUPERIORITY|||||||0.638|||||||t-test, 2 sided|||||||.638
72512665|NCT00165841|144555876|SUPERIORITY_OR_OTHER||||||<|0.0001||||||p-value was adjusted for multiple comparisons.|t-test, 2 sided|The primary analysis was on the ITT population using all observed data collected from Day 1 of the maintenance phase until the endpoint.||Efficacy analyses were based on the intent-to-treat (ITT) population, which was comprised of all patients in the safety-evaluable population who had a baseline and ≥1 post-randomization primary efficacy endpoint evaluation and who had received ≥1 dose of study medication during the maintenance phase.||||<0.0001
72512666|NCT00333619|144555917|SUPERIORITY_OR_OTHER|||||||0.1|TWO_SIDED||||||ANOVA|||||||0.10
72512667|NCT00333619|144555918|SUPERIORITY_OR_OTHER|||||||0.12|TWO_SIDED||||||ANOVA|||||||0.12
72512668|NCT00831441|144555945|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.95||||0.5094|TWO_SIDED|95.0|0.8|1.11|||Cox proportional hazard models|||A test of superiority at the one-sided α = 0.025 significance level for the primary efficacy outcome was performed.||1.11|0.80|0.5094
72512669|NCT00831441|144555946|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.94||||0.6702|TWO_SIDED|95.0|0.7|1.26|||Cox proportional hazard models|||||1.26|0.70|0.6702
72512670|NCT00831441|144555947|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.9||||0.6311|TWO_SIDED|95.0|0.57|1.4|||Cox proportional hazard models|||||1.40|0.57|0.6311
72512671|NCT00831441|144555948|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.93||||0.5086|TWO_SIDED|95.0|0.76|1.14|||Cox proportional hazard models|||||1.14|0.76|0.5086
72512672|NCT00831441|144555949|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.73||||0.1502|TWO_SIDED|95.0|0.47|1.12|||Cox proportional hazard models|||||1.12|0.47|0.1502
72512673|NCT00831441|144555950|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.94||||0.4317|TWO_SIDED|95.0|0.82|1.09|||Cox proportional hazard models|||||1.09|0.82|0.4317
72512674|NCT00831441|144555951|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.98||||0.8015|TWO_SIDED|95.0|0.83|1.15|||Cox proportional hazard models|||||1.15|0.83|0.8015
72512675|NCT00831441|144555952|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.99||||0.8948|TWO_SIDED|95.0|0.85|1.15|||Cox proportional hazard models|||||1.15|0.85|0.8948
72512676|NCT00831441|144555953|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.59||||0.0006|TWO_SIDED|95.0|1.5|4.46|||Cox Proportional Hazard model|||A point estimate and two-sided 95% confidence interval (CI) for relative risk, as measured by the hazard ratio and a p-value for the test of equality of rates (HR = 1) was calculated.||4.46|1.50|0.0006
72512677|NCT00831441|144555954|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.48|||<|0.0001|TWO_SIDED|95.0|1.72|3.58|||Cox Proportional Hazard model|||||3.58|1.72|<0.0001
72512678|NCT00831441|144555955|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.64|||<|0.0001|TWO_SIDED|95.0|1.87|3.72|||Cox Proportional Hazard model|||||3.72|1.87|<0.0001
72485366|NCT00621751|144498135|OTHER|A prespecified secondary analysis compared proportions of participants that experienced a decrease of \> 1 MCID in the NPI-I/A Rasch construct score (i.e., participants that are considered to have meaningful reduction in irritability/aggression) from baseline to day-42 between the groups using a chi-square test. MCID was defined as 0.5 times the standard deviation of baseline scores.|||||<|0.05|||||||ANCOVA|||||||< .05
72485367|NCT01809132|144498156|SUPERIORITY|||||||0.3|||||||Log Rank|||||||.30
72512679|NCT00831441|144555956|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.36|||<|0.0001|TWO_SIDED|95.0|2.06|2.7|||Cox Proportional Hazard model|||||2.70|2.06|<0.0001
72512680|NCT00960934|144555964|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|0.56||||0.749|TWO_SIDED|95.0|-1.04|2.16||The Type-I error rate over the multiple treatment dose comparisons for the areal BMD at lumbar spine endpoint were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||2.16|-1.04|0.749
72512681|NCT00960934|144555964|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|1.12||||0.333|TWO_SIDED|95.0|-0.6|2.83||The Type-I error rate over the multiple treatment dose comparisons for the areal BMD at lumbar spine endpoint were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||2.83|-0.60|0.333
72512682|NCT00960934|144555964|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|0.35||||0.823|TWO_SIDED|95.0|-1.14|1.84||The Type-I error rate over the multiple treatment dose comparisons for the areal BMD at lumbar spine endpoint were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||1.84|-1.14|0.823
72512683|NCT00960934|144555964|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|0.93||||0.457|TWO_SIDED|95.0|-0.75|2.61||The Type-I error rate over the multiple treatment dose comparisons for the areal BMD at lumbar spine endpoint were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||2.61|-0.75|0.457
72512684|NCT00960934|144555964|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|0.16||||0.823|TWO_SIDED|95.0|-1.17|1.5||The Type-I error rate over the multiple treatment dose comparisons for the areal BMD at lumbar spine endpoint were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||1.50|-1.17|0.823
72512685|NCT00960934|144555965|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|69.8|||<|0.001||95.0|56.5|80.0|||Miettinen and Nurminen Method|||The Miettinen and Nurminen Method was used to estimate the treatment differences between the active dose group and the placebo group by comparing the percentage of participants in the active dose group with the event vs. the percentage of participants in the placebo group with the event. An associated p-value and 95% confidence interval were calculated for this difference.||80.0|56.5|<0.001
72512686|NCT00960934|144555965|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|53.1|||<|0.001|TWO_SIDED|95.0|39.6|65.2|||Miettinen and Nurminen Method|||The Miettinen and Nurminen Method was used to estimate the treatment differences between the active dose group and the placebo group by comparing the percentage of participants in the active dose group with the event vs. the percentage of participants in the placebo group with the event. An associated p-value and 95% confidence interval were calculated for this difference.||65.2|39.6|<0.001
72512687|NCT00960934|144555965|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|29.6|||<|0.001|TWO_SIDED|95.0|17.6|42.4|||Miettinen and Nurminen Method|||The Miettinen and Nurminen Method was used to estimate the treatment differences between the active dose group and the placebo group by comparing the percentage of participants in the active dose group with the event vs. the percentage of participants in the placebo group with the event. An associated p-value and 95% confidence interval were calculated for this difference.||42.4|17.6|<0.001
72512688|NCT00960934|144555965|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|29.1|||<|0.001|TWO_SIDED|95.0|17.0|42.0|||Miettinen and Nurminen Method|||The Miettinen and Nurminen Method was used to estimate the treatment differences between the active dose group and the placebo group by comparing the percentage of participants in the active dose group with the event vs. the percentage of participants in the placebo group with the event. An associated p-value and 95% confidence interval were calculated for this difference.||42.0|17.0|<0.001
72512689|NCT00960934|144555965|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.6||||0.254|TWO_SIDED|95.0|-4.1|14.4|||Miettinen and Nurminen Method|||The Miettinen and Nurminen Method was used to estimate the treatment differences between the active dose group and the placebo group by comparing the percentage of participants in the active dose group with the event vs. the percentage of participants in the placebo group with the event. An associated p-value and 95% confidence interval were calculated for this difference.||14.4|-4.1|0.254
72567657|NCT00605865|144666682|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||not adjusted, p=0.050|Chi-squared|||"The factor tested was suicidal ideation (including suicide attempt). The null hypothesis is there is no difference between with or without suicidal ideation (including suicide attempt) in the participants of responders."||||<0.001
72567658|NCT02119286|144666760|SUPERIORITY_OR_OTHER||Least squared mean difference|0.122|||<|0.001|TWO_SIDED|95.0|0.091|0.152|||Mixed Model Repeated Measure|Restricted maximum likelihood (REM) - based repeated measure approach (MMRM)||||0.152|0.091|<0.001
72567659|NCT02119286|144666760|SUPERIORITY_OR_OTHER||Least squared mean difference|0.111|||<|0.001|TWO_SIDED|95.0|0.081|0.141|||Mixed Model Repeated Measure|Restricted maximum likelihood (REM) - based repeated measure approach (MMRM)||||0.141|0.081|<0.001
72485368|NCT01809132|144498157|SUPERIORITY|||||||0.42|||||||t-test, 2 sided|||the observational subject was lost to follow-up||||.42
72485369|NCT01809132|144498158|SUPERIORITY|||||||0.75|||||||t-test, 2 sided|||||||.75
72485370|NCT01809132|144498159|SUPERIORITY|||||||0.17|||||||t-test, 2 sided|||||||.17
72485371|NCT03349775|144498160|SUPERIORITY||Median Difference (Final Values)|-2.57|STANDARD_DEVIATION|5.14||0.35|TWO_SIDED|95.0|-8.32|3.18|||t-test, 2 sided|||||3.18|-8.32|0.35
72485372|NCT03349775|144498161|SUPERIORITY||Median Difference (Final Values)|1.13|STANDARD_DEVIATION|2.13||0.37|TWO_SIDED|95.0|-1.65|3.92|||t-test, 2 sided|||||3.92|-1.65|0.37
72485373|NCT01516970|144498163|SUPERIORITY_OR_OTHER|||||||0.2434||||||The discontinuation rates were compared with a statistical test (Cochran-Mantel-Haenszel \[CMH\]-Test) with p-value: 0.2434|Cochran-Mantel-Haenszel|||||||0.2434
72576909|NCT00261443|144680713|SUPERIORITY_OR_OTHER_LEGACY|||||||0.871||95.0|||||Wilcoxon Rank Sum Test|||Baseline Treatment Comparison; Aripiprazole/Placebo||||0.871
72402639|NCT01480076|144311688|SUPERIORITY_OR_OTHER||difference of LS means|0.8|STANDARD_ERROR_OF_MEAN|1.38||0.5561|TWO_SIDED||||||mixed effect model|||Month 9, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline MCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.5561
72402640|NCT01480076|144311688|SUPERIORITY_OR_OTHER||difference of LS means|2.8|STANDARD_ERROR_OF_MEAN|2.32||0.2281|TWO_SIDED||||||mixed effect model|||Month 9, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline MCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.2281
72402641|NCT01480076|144311688|SUPERIORITY_OR_OTHER|||||||0.0006|||||||mixed effect model|||Month 12, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline MCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0006
72402642|NCT01480076|144311688|SUPERIORITY_OR_OTHER|||||||0.6004|||||||mixed effect model|||Month 12, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline MCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.6004
72402643|NCT01480076|144311688|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 12, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline MCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
72402644|NCT01480076|144311688|SUPERIORITY_OR_OTHER|||||||0.904|||||||mixed effect model|||Month 12, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline MCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.9040
72402645|NCT01480076|144311688|SUPERIORITY_OR_OTHER||difference of LS means|2.8|STANDARD_ERROR_OF_MEAN|1.38||0.0401|TWO_SIDED||||||mixed effect model|||Month 12, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline MCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0401
72485374|NCT01516970|144498164|SUPERIORITY_OR_OTHER|||||||0.8839||||||The percentage of participants with TEAEs were compared with a statistical test (Fisher's Exact Test) with p-value: 0.8839.|Fisher Exact|||||||0.8839
72485375|NCT01756040|144498168|OTHER|||||||0.932||||||not adjusted for multiple comparisons. The a priori threshold for statistical significance was \<0.05.|t-test, 2 sided|||We hypothesized that intestinal permeability as measured by urinary lactulose/rhamnose ratio would be higher in the lower gestational age (\<29 weeks) compared to the more mature infants (≥29 weeks gestation) at postnatal age 7-10 days.||||0.932
72485376|NCT01756040|144498169|OTHER|||||||0.316|||||||t-test, 2 sided|||We hypothesized that stool A1AT would be higher in infants with high IP as measured by urinary La/Rh compared to those with low IP.||||0.316
72485377|NCT01756040|144498170|OTHER|||||||0.011||||||The significance value was estimated using Bayesian goodness-of-fit p-value to assess the significance of the association of the relative abundance of Clostridiales and IP categories. P value \<0.05 was considered significant.|Bayesian goodness of fit|||||||0.011
72485378|NCT01756040|144498171|OTHER|||||||0.0023|||||||t-test, 2 sided|||We hypothesized that infants with normal barrier function (La/Rh ratio ≤0.05) would have been fed breastmilk for longer duration than infants with impaired barrier function (La/Rh\>0.05).||||0.0023
72402646|NCT01480076|144311688|SUPERIORITY_OR_OTHER||difference of LS means|4.1|STANDARD_ERROR_OF_MEAN|2.23||0.0651|TWO_SIDED||||||mixed effect model|||Month 12, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline MCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0651
72402647|NCT01480076|144311689|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Overall, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 physical score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
72485379|NCT01756040|144498172|OTHER|||||||1|||||||Chi-squared|||||||1.0
72485380|NCT01756040|144498173|OTHER|||||||0.461||||||A priori threshold \<0.05|Chi-squared|||||||0.461
72485381|NCT01756040|144498174|OTHER|||||||0.019|||||||t-test, 2 sided|||We hypothesized that infants with impaired barrier function as measured by high urinary La/Rh (\>0.05) ratio at 7-10 days of age would require longer time to reach full enteral feedings than infants with normal barrier function (La/Rh≤0.05)||||0.019
72485382|NCT00892177|144498175|SUPERIORITY_OR_OTHER_LEGACY||Maximum Tolerated Dose (mg)|100.0|||||TWO_SIDED|||||||||||||
72485383|NCT00892177|144498176|SUPERIORITY_OR_OTHER_LEGACY||Difference|0.1||||0.22|TWO_SIDED|95.0|-0.052|0.262|||Chi-squared, Corrected||Difference in proportion|||0.262|-0.052|0.22
72485384|NCT00892177|144498178|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.92||||0.7|TWO_SIDED|95.0|0.61|1.4|||Kaplan Meier|||||1.4|0.61|0.7
72485385|NCT00892177|144498179|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.14||||0.52|TWO_SIDED|95.0|0.76|1.7|||Kaplan Meier|||||1.7|0.76|0.52
72567660|NCT02119286|144666761|SUPERIORITY_OR_OTHER||Least squared mean difference|0.147|||<|0.001|TWO_SIDED|95.0|0.114|0.179|||Mixed Model Repeated Measure|Restricted maximum likelihood (REM) - based repeated measure approach (MMRM)||||0.179|0.114|<0.001
72402648|NCT01480076|144311689|SUPERIORITY_OR_OTHER|||||||0.454|||||||mixed effect model|||Overall, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 physical score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.4540
72485386|NCT00892177|144498180|SUPERIORITY||Mean Difference (Final Values)|-0.223||||0.96|TWO_SIDED||||||Mixed Models Analysis||The estimate is the net difference between Arm A and Arm B total score using information from all cycles. A negative value means that Arm A has a lower quality of life and a positive value means Arm A has a higher reported quality of life.|||||0.96
72485387|NCT00892177|144498181|SUPERIORITY|||||||0.6325|||||||Fisher Exact|||||||0.6325
72485388|NCT02645760|144498182|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANCOVA|||It was calculated that 38 participants randomized in a 1:1 fashion between the 2 arms would have at least 80% power to detect a difference of 2.26 points in mean 11-point NRS pain score between core stabilization exercise and conventional treatment from baseline to week 7.||||<0.001
72485389|NCT02645760|144498183|SUPERIORITY_OR_OTHER|||||||0.009|||||||ANCOVA|||It was calculated that 38 participants randomized in a 1:1 fashion between the 2 arms would have at least 80% power to detect a difference of 2.68 points in mean disability score (RMDQ score) between core stabilization exercise and conventional treatment from baseline to week 7.||||0.009
72485390|NCT02645760|144498184|SUPERIORITY_OR_OTHER|||||||0.013|||||||ANCOVA|||It was calculated that 38 participants randomized in a 1:1 fashion between the 2 arms would have at least 80% power to detect a difference of 0.79 centimeter in mean range of motion between core stabilization exercise and conventional treatment from baseline to week 7.||||0.013
72485391|NCT02645760|144498185|SUPERIORITY_OR_OTHER|||||||0.012|||||||ANCOVA|||It was calculated that 38 participants randomized in a 1:1 fashion between the 2 arms would have at least 80% power to detect a difference of 0.30 centimeter in mean repositioning error between core stabilization exercise and conventional treatment from baseline to week 7.||||0.012
72485392|NCT02267603|144498192|OTHER|The null hypothesis will be rejected if 3 or more responses are observed in 24 patients. This design yields a type I error rate of 0.10 and power of 0.90 when the true response rate is 25%. Progression-free survival (PFS) at 16 months will be estimated by Kaplan-Meier method. Unless otherwise stated, all statistical tests will be conducted at the α=0.05 (1-sided) level.||||||||||||||||The protocol was designed w/ a standard Simon 2 stage design. Null hypothesis that true response rate is 5% was tested against a 1-sided alternative. In stage 1, 9 patients were accrued. If no responses in these 9 patients, study was to stop. Otherwise,15 more patients were to be accrued for a total of 24 patients. Study was amended to increase number of patients to 50, following discussion w/ pharmaceutical collaborator and FDA.|ORR will be estimated as the # of responders as a % of the # of eligible participants who received at least 1 dose of treatment. If a substantial amount of primary endpoint data are missing (at least 1 value missing from more than 20% of participants), using nonparametric estimation to estimate the ORR requires the missing completely at random assumption may give misleading results. In this case, analyses of the primary endpoint will be performed using parametric generalized linear models fit by maximum likelihood. These methods provide unbiased estimation and inferences under the parametric modeling assumptions and the assumption that the missing data are missing at random (MAR). MAR assumes that the probability of an observation being missing may depend upon the observed responses and upon observed covariates. A generalized linear model for the ORR will use a binomial error distribution. The model will include as covariates all available baseline predictors of the missing outcomes.|||
72485393|NCT01509079|144498217|SUPERIORITY_OR_OTHER|||||||0.38|||||||ANOVA|||||||0.38
72512690|NCT00960934|144555966|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|47.6|||<|0.001|TWO_SIDED|95.0|34.9|60.0|||Miettinen and Nurminen Method|||The Miettinen and Nurminen Method was used to estimate the treatment differences between the active dose group and the placebo group by comparing the percentage of participants in the active dose group with the event vs. the percentage of participants in the placebo group with the event. An associated p-value and 95% confidence interval were calculated for this difference.||60.0|34.9|<0.001
72512691|NCT00960934|144555966|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|35.9|||<|0.001|TWO_SIDED|95.0|24.1|48.5|||Miettinen and Nurminen Method|||The Miettinen and Nurminen Method was used to estimate the treatment differences between the active dose group and the placebo group by comparing the percentage of participants in the active dose group with the event vs. the percentage of participants in the placebo group with the event. An associated p-value and 95% confidence interval were calculated for this difference.||48.5|24.1|<0.001
72512692|NCT00960934|144555966|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|17.2||||0.001|TWO_SIDED|95.0|7.7|28.7|||Miettinen and Nurminen Method|||The Miettinen and Nurminen Method was used to estimate the treatment differences between the active dose group and the placebo group by comparing the percentage of participants in the active dose group with the event vs. the percentage of participants in the placebo group with the event. An associated p-value and 95% confidence interval were calculated for this difference.||28.7|7.7|0.001
72512693|NCT00960934|144555966|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.1||||0.05|TWO_SIDED|95.0|0.0|18.2|||Miettinen and Nurminen Method|||The Miettinen and Nurminen Method was used to estimate the treatment differences between the active dose group and the placebo group by comparing the percentage of participants in the active dose group with the event vs. the percentage of participants in the placebo group with the event. An associated p-value and 95% confidence interval were calculated for this difference.||18.2|-0.0|0.050
72512694|NCT00960934|144555966|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.6||||0.313|TWO_SIDED|95.0|-8.5|4.2|||Miettinen and Nurminen Method|||The Miettinen and Nurminen Method was used to estimate the treatment differences between the active dose group and the placebo group by comparing the percentage of participants in the active dose group with the event vs. the percentage of participants in the placebo group with the event. An associated p-value and 95% confidence interval were calculated for this difference.||4.2|-8.5|0.313
72567661|NCT02119286|144666761|SUPERIORITY_OR_OTHER||Least squared mean difference|0.135|||<|0.001|TWO_SIDED|95.0|0.103|0.167|||Mixed Model Repeated Measure|Restricted maximum likelihood (REM) - based repeated measure approach (MMRM)||||0.167|0.103|<0.001
72576910|NCT00261443|144680713|SUPERIORITY_OR_OTHER_LEGACY|||||||0.362||95.0|||||Wilcoxon Rank Sum Test|||Week 52 LOCF Treatment Comparison; Aripiprazole/Placebo||||0.362
72576911|NCT00261443|144680713|SUPERIORITY_OR_OTHER_LEGACY|||||||0.295||95.0|||||Wilcoxon Rank Sum Test|||Highest Value Treatment Comparison; Aripiprazole/Placebo||||0.295
72567662|NCT02040779|144666769|SUPERIORITY||LSM difference|0.116||||0.001|TWO_SIDED|95.0|0.048|0.185||ANCOVA model with effects due to baseline trough morning FEV1, sex, age, current protocol-allowed asthma therapy (ICS or non-corticosteroid therapy) at the time of screening visit and during the run-in period and treatment.|ANCOVA||BDP 160 mcg BAI - Placebo BAI|A fixed-sequence multiple testing procedure was used while controlling the family-wise error rate at 5%. If the 2-sided p-value resulting from the ANCOVA model for comparing beclomethasone dipropionate BAI 160 mcg/day versus placebo was less than 0.05, then the comparison of the 80 mcg/day versus placebo was to be interpreted inferentially.||0.185|0.048|0.0010
72567663|NCT02040779|144666769|SUPERIORITY||LSM difference|0.124||||0.0005|TWO_SIDED|95.0|0.054|0.193||ANCOVA model with effects due to baseline trough morning FEV1, sex, age, current protocol-allowed asthma therapy (ICS or non-corticosteroid therapy) at the time of screening visit and during the run-in period and treatment.|ANCOVA||BDP 80 mcg BAI - Placebo BAI|||0.193|0.054|0.0005
72567664|NCT02040779|144666770|SUPERIORITY||LSM difference|7.911||||0.0443|TWO_SIDED|95.0|0.202|15.621||a priori threshold for significance of 0.05.|mixed model for repeated measures||BDP 160 mcg BAI - Placebo BAI|Treatment comparisons began with am PEF for BDP 160 mcg BAI vs placebo. If the p-value was ≤0.05, the next comparisons of interest were made 1) the next secondary outcome comparison for BDP 160 mcg BAI vs placebo and 2) the am PEF for BDP 80 mcg BAI vs placebo. This procedure allowed for control of the Type I error for comparisons at a particular BAI treatment over the 5 secondary endpoints, as well as comparisons within an endpoint. It did not control the overall Type I error.||15.621|0.202|0.0443
72567665|NCT02040779|144666770|SUPERIORITY||LSM difference|13.645||||0.0007|TWO_SIDED|95.0|5.843|21.446||a priori threshold for significance of 0.05.|mixed model for repeated measures||BDP 160 mcg BAI - Placebo BAI|Treatment comparisons began with am PEF for BDP 160 mcg BAI vs placebo. If the p-value was ≤0.05, the next comparisons of interest were made 1) the next secondary outcome comparison for BDP 160 mcg BAI vs placebo and 2) the am PEF for BDP 80 mcg BAI vs placebo. This procedure allowed for control of the Type I error for comparisons at a particular BAI treatment over the 5 secondary endpoints, as well as comparisons within an endpoint. It did not control the overall Type I error.||21.446|5.843|0.0007
72567666|NCT02040779|144666771|SUPERIORITY||LSM difference|5.405||||0.2014|TWO_SIDED|95.0|-2.905|13.715||a priori threshold for significance of 0.05.|mixed model for repeated measures||BDP 160 mcg BAI - Placebo BAI|Treatment comparisons began with am PEF for BDP 160 mcg BAI vs placebo. If the p-value was ≤0.05, the next comparisons of interest were made 1) the next secondary outcome comparison for BDP 160 mcg BAI vs placebo and 2) the am PEF for BDP 80 mcg BAI vs placebo. This procedure allowed for control of the Type I error for comparisons at a particular BAI treatment over the 5 secondary endpoints, as well as comparisons within an endpoint. It did not control the overall Type I error.||13.715|-2.905|0.2014
72567667|NCT02040779|144666771|SUPERIORITY||LSM difference|10.902||||0.0112|TWO_SIDED|95.0|2.5|19.303||a priori threshold for significance of 0.05.|mixed model for repeated measures||BDP 160 mcg BAI - Placebo BAI|Treatment comparisons began with am PEF for BDP 160 mcg BAI vs placebo. If the p-value was ≤0.05, the next comparisons of interest were made 1) the next secondary outcome comparison for BDP 160 mcg BAI vs placebo and 2) the am PEF for BDP 80 mcg BAI vs placebo. This procedure allowed for control of the Type I error for comparisons at a particular BAI treatment over the 5 secondary endpoints, as well as comparisons within an endpoint. It did not control the overall Type I error.||19.303|2.500|0.0112
72567668|NCT02040779|144666772|SUPERIORITY||LSM difference|-0.388||||0.0175|TWO_SIDED|95.0|-0.708|-0.068||a priori threshold for significance of 0.05.|mixed model for repeated measures||BDP 160 mcg BAI - Placebo BAI|Treatment comparisons began with am PEF for BDP 160 mcg BAI vs placebo. If the p-value was ≤0.05, the next comparisons of interest were made 1) the next secondary outcome comparison for BDP 160 mcg BAI vs placebo and 2) the am PEF for BDP 80 mcg BAI vs placebo. This procedure allowed for control of the Type I error for comparisons at a particular BAI treatment over the 5 secondary endpoints, as well as comparisons within an endpoint. It did not control the overall Type I error.||-0.068|-0.708|0.0175
72567669|NCT02040779|144666772|SUPERIORITY||LSM difference|-0.358||||0.0285|TWO_SIDED|95.0|-0.678|-0.038||a priori threshold for significance of 0.05.|mixed model for repeated measures||BDP 80 mcg BAI - Placebo BAI|Treatment comparisons began with am PEF for BDP 160 mcg BAI vs placebo. If the p-value was ≤0.05, the next comparisons of interest were made 1) the next secondary outcome comparison for BDP 160 mcg BAI vs placebo and 2) the am PEF for BDP 80 mcg BAI vs placebo. This procedure allowed for control of the Type I error for comparisons at a particular BAI treatment over the 5 secondary endpoints, as well as comparisons within an endpoint. It did not control the overall Type I error.||-0.038|-0.678|0.0285
72567670|NCT02040779|144666773|SUPERIORITY||LSM difference|-0.137||||0.0335|TWO_SIDED|95.0|-0.263|-0.011||a priori threshold for significance of 0.05.|mixed model for repeated measures||BDP 160 mcg BAI - Placebo BAI|Treatment comparisons began with am PEF for BDP 160 mcg BAI vs placebo. If the p-value was ≤0.05, the next comparisons of interest were made 1) the next secondary outcome comparison for BDP 160 mcg BAI vs placebo and 2) the am PEF for BDP 80 mcg BAI vs placebo. This procedure allowed for control of the Type I error for comparisons at a particular BAI treatment over the 5 secondary endpoints, as well as comparisons within an endpoint. It did not control the overall Type I error.||-0.011|-0.263|0.0335
72567671|NCT02040779|144666773|SUPERIORITY||LSM difference|-0.127||||0.0509|TWO_SIDED|95.0|-0.255|0.001||a priori threshold for significance of 0.05.|mixed model for repeated measures||BDP 80 mcg BAI - Placebo BAI|Treatment comparisons began with am PEF for BDP 160 mcg BAI vs placebo. If the p-value was ≤0.05, the next comparisons of interest were made 1) the next secondary outcome comparison for BDP 160 mcg BAI vs placebo and 2) the am PEF for BDP 80 mcg BAI vs placebo. This procedure allowed for control of the Type I error for comparisons at a particular BAI treatment over the 5 secondary endpoints, as well as comparisons within an endpoint. It did not control the overall Type I error.||0.001|-0.255|0.0509
72567672|NCT02040779|144666775|SUPERIORITY|||||||0.2384|||||||Log Rank|||||||0.2384
72485394|NCT00314249|144498252|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-6.38||||||95.0|-8.56|-4.19|||ANCOVA|||This parameter was analyzed using an ANCOVA model with treatment group and study center as factors and baseline value as a covariate.||-4.19|-8.56|
72485395|NCT00314249|144498253|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.53||||||95.0|-0.69|-0.38|||ANOVA|||This parameter was analyzed using an ANOVA model with treatment group and study center as factors.||-0.38|-0.69|
72485396|NCT00314249|144498254|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.69||||||95.0|-3.27|-0.11|||ANCOVA|||This parameter was analyzed using an ANCOVA model with treatment group and study center as factors and baseline value as a covariate.||-0.11|-3.27|
72485397|NCT00314249|144498255|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.06|||<|0.001||95.0|1.45|2.94||Closed testing procedure used to control overall type 1 error rate at 5%: fibromyalgia syndrome tested prior to fibromyalgia pain|Regression, Logistic|||The test of no difference in the responder rate between milnacipran and placebo groups was performed using a logistic regression model with treatment group, baseline pain score, and baseline SF-36 PCS score as explanatory variables.||2.94|1.45|<0.001
72485398|NCT00314249|144498256|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.86|||<|0.001||95.0|1.38|2.51||Closed testing procedure was used to control overall type 1 error rate at 5%: fibromyalgia pain tested after statistically significant fibromyalgia syndrome test|Regression, Logistic|||The test of no difference in the responder rate between milnacipran and placebo groups was performed using a logistic regression model with the treatment group and baseline pain score as explanatory variables.||2.51|1.38|<0.001
72485399|NCT00314249|144498257|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.65||||||95.0|0.86|2.44|||ANCOVA|||This parameter was analyzed using an ANCOVA model with treatment group and study center as factors and baseline value as a covariate.||2.44|0.86|
72485400|NCT03334409|144498286|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.0
72485401|NCT03334409|144498287|SUPERIORITY|||||||0.08|||||||Log Rank|||||||0.08
72485402|NCT03334409|144498288|SUPERIORITY|||||||0.08|||||||Log Rank|||||||0.08
72485403|NCT03334409|144498289|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1
72485404|NCT03334409|144498290|SUPERIORITY|||||||0.18|||||||Kruskal-Wallis|||||||0.18
72512695|NCT00960934|144555967|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|||>|0.999|TWO_SIDED|95.0|-5.8|5.8|||Miettinen and Nurminen Method|||The Miettinen and Nurminen Method was used to estimate the treatment differences between the active dose group and the placebo group by comparing the percentage of participants in the active dose group with the event vs. the percentage of participants in the placebo group with the event. An associated p-value and 95% confidence interval were calculated for this difference.||5.8|-5.8|>0.999
72512696|NCT00960934|144555967|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|||>|0.999|TWO_SIDED|95.0|-5.8|5.7|||Miettinen and Nurminen Method|||The Miettinen and Nurminen Method was used to estimate the treatment differences between the active dose group and the placebo group by comparing the percentage of participants in the active dose group with the event vs. the percentage of participants in the placebo group with the event. An associated p-value and 95% confidence interval were calculated for this difference.||5.7|-5.8|>0.999
72512697|NCT00960934|144555967|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|||>|0.999|TWO_SIDED|95.0|-5.8|5.7|||Miettinen and Nurminen Method|||The Miettinen and Nurminen Method was used to estimate the treatment differences between the active dose group and the placebo group by comparing the percentage of participants in the active dose group with the event vs. the percentage of participants in the placebo group with the event. An associated p-value and 95% confidence interval were calculated for this difference.||5.7|-5.8|>0.999
72512698|NCT00960934|144555967|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.6||||0.313|TWO_SIDED|95.0|-4.2|8.6|||Miettinen and Nurminen Method|||The Miettinen and Nurminen Method was used to estimate the treatment differences between the active dose group and the placebo group by comparing the percentage of participants in the active dose group with the event vs. the percentage of participants in the placebo group with the event. An associated p-value and 95% confidence interval were calculated for this difference.||8.6|-4.2|0.313
72512699|NCT00960934|144555967|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.6||||0.321|TWO_SIDED|95.0|-4.3|8.4|||Miettinen and Nurminen Method|||The Miettinen and Nurminen Method was used to estimate the treatment differences between the active dose group and the placebo group by comparing the percentage of participants in the active dose group with the event vs. the percentage of participants in the placebo group with the event. An associated p-value and 95% confidence interval were calculated for this difference.||8.4|-4.3|0.321
72512700|NCT00960934|144555969|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|0.24||||0.959|TWO_SIDED|95.0|-1.03|1.51||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||1.51|-1.03|0.959
72512701|NCT00960934|144555969|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|-0.02||||0.971|TWO_SIDED|95.0|-1.08|1.04||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||1.04|-1.08|0.971
72512702|NCT00960934|144555969|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|0.24||||0.959|TWO_SIDED|95.0|-0.95|1.42||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||1.42|-0.95|0.959
72485405|NCT03334409|144498291|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1
72485406|NCT01892306|144498332|SUPERIORITY_OR_OTHER|||||||0.02|||||||Mixed Models Analysis|||Scores on the HAM-A were analyzed using a mixed-effects linear regression analysis over 6 timepoints.||||.02
72485407|NCT01892306|144498333|SUPERIORITY_OR_OTHER|||||||0.02|||||||Mixed Models Analysis|||Scores on the HAM-D were analyzed using a mixed-effects linear regression analysis over 6 timepoints.||||0.02
72485408|NCT01892306|144498334|SUPERIORITY_OR_OTHER|||||||0.24|||||||Mixed Models Analysis|||Scores on the CSQ were analyzed using a mixed-effects linear regression analysis over 6 timepoints.||||0.24
72485409|NCT01892306|144498335|OTHER|||||||0.62|||||||Regression, Linear|||Linear regression - Dependent variable: HAM-A symptom change; Independent variable: Baseline DERS scores.||||.62
72485410|NCT01892306|144498335|OTHER|||||||0.03|||||||Regression, Linear|||Linear Regression - Dependent variable: HAM-A symptom change; Independent variable: Baseline DERS scores||||.03
72485411|NCT01892306|144498336|OTHER|||||||0.95|||||||Regression, Linear|||Linear regression - Dependent variable: HAM-A symptom change; Independent variable: Baseline ACS scores.||||0.95
72485412|NCT01892306|144498336|OTHER|||||||0.03|||||||Regression, Linear|||Linear Regression - Dependent variable: HAM-A symptom change; Independent variable: Baseline ACS scores.||||0.03
72485413|NCT01892306|144498337|OTHER|||||||0.87|||||||Regression, Linear|||Linear Regression - Dependent variable: HAM-A symptom change; Independent variable: Baseline ASI scores||||0.87
72485414|NCT01892306|144498337|OTHER|||||||0.37|||||||Regression, Linear|||Linear Regression - Dependent variable: HAM-A symptom change; Independent variable: Baseline ASI scores||||0.37
72567673|NCT02040779|144666775|SUPERIORITY|||||||0.0208|||||||Log Rank|||||||0.0208
72512703|NCT00960934|144555969|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|-0.41||||0.915|TWO_SIDED|95.0|-1.78|0.97||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||0.97|-1.78|0.915
72512704|NCT00960934|144555969|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|-0.28||||0.959|TWO_SIDED|95.0|-1.6|1.04||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||1.04|-1.60|0.959
72512705|NCT00960934|144555970|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|0.58||||0.849|TWO_SIDED|95.0|-1.22|2.37||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||2.37|-1.22|0.849
72512706|NCT00960934|144555970|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|-0.16||||0.964|TWO_SIDED|95.0|-1.79|1.47||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||1.47|-1.79|0.964
72512707|NCT00960934|144555970|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|0.16||||0.964|TWO_SIDED|95.0|-1.27|1.59||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||1.59|-1.27|0.964
72512708|NCT00960934|144555970|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|-0.48||||0.855|TWO_SIDED|95.0|-2.23|1.27||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||1.27|-2.23|0.855
72567674|NCT03716076|144666798|OTHER|mixed-effects linear regression|||||||||||||||||To compare time values to baseline, post-hoc Tukey's test was applied|||
72512709|NCT00960934|144555970|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|1.27||||0.287|TWO_SIDED|95.0|-0.58|3.12||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||3.12|-0.58|0.287
72512710|NCT00960934|144555971|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|0.6||||0.933|TWO_SIDED|95.0|-1.56|2.77||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||2.77|-1.56|0.933
72512711|NCT00960934|144555971|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|-0.01||||0.999|TWO_SIDED|95.0|-1.69|1.68||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||1.68|-1.69|0.999
72512712|NCT00960934|144555971|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|0.05||||0.999|TWO_SIDED|95.0|-1.84|1.93||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||1.93|-1.84|0.999
72512713|NCT00960934|144555971|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|0.45||||0.959|TWO_SIDED|95.0|-1.67|2.57||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||2.57|-1.67|0.959
72512714|NCT00960934|144555971|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|-0.08||||0.999|TWO_SIDED|95.0|-2.1|1.94||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||1.94|-2.10|0.999
72512715|NCT00960934|144555972|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|-0.17||||0.976|TWO_SIDED|95.0|-1.12|0.77||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||0.77|-1.12|0.976
72512716|NCT00960934|144555972|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|-0.06||||0.982|TWO_SIDED|95.0|-0.93|0.8||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||0.80|-0.93|0.982
72512717|NCT00960934|144555972|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|0.53||||0.489|TWO_SIDED|95.0|-0.43|1.49||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||1.49|-0.43|0.489
72512718|NCT00960934|144555972|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|0.02||||0.982|TWO_SIDED|95.0|-0.75|0.78||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||0.78|-0.75|0.982
72567675|NCT01388166|144666817|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
72567676|NCT01388166|144666818|SUPERIORITY_OR_OTHER|||||||0.0002|||||||t-test, 2 sided|||||||0.0002
72567677|NCT01388166|144666819|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
72567678|NCT03687658|144666830|OTHER|Generalized linear mixed model (GLMM) with a binomial distribution using a logit link function||||||0.066|||||||Generalized linear mixed model|||||||0.066
72567679|NCT03687658|144666831|OTHER|Generalized linear mixed model (GLMM) with a binomial distribution using a logit link function||||||0.273|||||||Generalized linear mixed model|||||||0.273
72567680|NCT03687658|144666832|OTHER|Generalized linear mixed model (GLMM) with a Poisson distribution using a log link function||||||0.403|||||||Generalized linear mixed model|||||||0.403
72567681|NCT01765582|144666900|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.62||||0.132|TWO_SIDED|90.0|0.96|2.71|||Cochran-Mantel-Haenszel|||Stratified by extent of metastatic disease (liver-limited disease versus non liver-limited disease) and tumor location (right versus left) after correction post-randomization.||2.71|0.96|0.132
72576912|NCT00261443|144680713|SUPERIORITY_OR_OTHER_LEGACY|||||||0.519||95.0|||||Wilcoxon Rank Sum Test|||Lowest Value Treatment Comparison; Aripiprazole/Placebo||||0.519
72485415|NCT01892306|144498338|OTHER|||||||0.17|||||||Regression, Linear|||Linear Regression - Dependent variable: HAM-A symptom change; Independent variable: Baseline NEO- Neuroticism scores.||||0.17
72485416|NCT01892306|144498338|OTHER|||||||0.04|||||||Regression, Linear|||Linear Regression - Dependent variable: HAM-A symptom change; Independent variable: Baseline NEO-Neuroticism scores||||.04
72485417|NCT01892306|144498339|OTHER|||||||0.007|||||||Regression, Linear|||Fisher's z-transformed values for functional connectivity between anterior insula and ventrolateral prefrontal cortex were entered in separate treatment group-specific linear regression models as the independent variable with change in primary outcomes (HAM-D) as dependent variable.||||0.007
72485418|NCT01892306|144498339|OTHER|||||||0.14|||||||Regression, Linear|||Fisher's z-transformed values for functional connectivity between anterior insula and ventrolateral prefrontal cortex were entered in separate treatment group-specific linear regression models as the independent variable with change in primary outcomes (HAM-D) as dependent variable.||||.14
72485419|NCT00962390|144498361|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3||||0.4678|TWO_SIDED|95.0|-0.5|1.1||Statistical testing was 2-sided and the 5% significant level was used.|ANCOVA|The ANCOVA included Baseline as covariate and factors for treatment and site.|S-equol treatment group minus placebo group.|Week 4, Treatment Effect||1.1|-0.5|0.4678
72485420|NCT00962390|144498361|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3||||0.4892|TWO_SIDED|95.0|-0.5|1.1||Statistical testing was 2-sided and the 5% significant level was used.|ANCOVA|The ANCOVA included Baseline as covariate and factors for treatment and site.|S-equol treatment group minus placebo group.|Week 4, Treatment Effect||1.1|-0.5|0.4892
72485421|NCT00962390|144498361|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||0.8185|TWO_SIDED|95.0|-0.8|1.0||Statistical testing was 2-sided and the 5% significant level was used.|ANCOVA|The ANCOVA included Baseline as covariate and factors for treatment and site.|S-equol treatment group minus placebo group.|Week 4, Treatment Effect||1.0|-0.8|0.8185
72485422|NCT00038727|144498408|SUPERIORITY||Hazard Ratio (HR)|1.02||||0.87|TWO_SIDED|95.0|0.81|1.28|||Log Rank|||||1.28|0.81|0.87
72485423|NCT00038727|144498408|SUPERIORITY||Hazard Ratio (HR)|0.99||||0.95|TWO_SIDED|95.0|0.79|1.25|||Log Rank|||||1.25|0.79|0.95
72485424|NCT03740997|144498409|OTHER||Mean Difference (Net)|16.2|STANDARD_DEVIATION|5.46||0.0008|TWO_SIDED|95.0|10.44|21.89|||Paired t-test|||Reader 1: Difference Between Non-contrast and OPTISON Dose Level 1||21.89|10.44|0.0008
72512719|NCT00960934|144555972|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|0.16||||0.976|TWO_SIDED|95.0|-0.76|1.08||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||1.08|-0.76|0.976
72512720|NCT00960934|144555973|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|-0.35||||0.961|TWO_SIDED|95.0|-2.0|1.31||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||1.31|-2.00|0.961
72512721|NCT00960934|144555973|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|-0.28||||0.961|TWO_SIDED|95.0|-1.9|1.34||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||1.34|-1.90|0.961
72512722|NCT00960934|144555973|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|0.66||||0.778|TWO_SIDED|95.0|-1.01|2.33||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||2.33|-1.01|0.778
72512723|NCT00960934|144555973|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|-0.11||||0.961|TWO_SIDED|95.0|-1.45|1.24||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||1.24|-1.45|0.961
72512724|NCT00960934|144555973|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|-0.25||||0.961|TWO_SIDED|95.0|-1.77|1.26||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||1.26|-1.77|0.961
72485425|NCT03740997|144498409|OTHER||Mean Difference (Net)|17.1|STANDARD_DEVIATION|13.49|<|0.0001|TWO_SIDED|95.0|11.11|23.07|||Paired t-test|||Reader 1: Difference Between Non-contrast and OPTISON Dose Level 1||23.07|11.11|<0.0001
72576913|NCT00261443|144680714|SUPERIORITY_OR_OTHER_LEGACY|||||||0.935||95.0|||||Wilcoxon Rank Sum Test|||Baseline Treatment Comparison; Aripiprazole/Placebo||||0.935
72485426|NCT03740997|144498409|OTHER||Mean Difference (Net)|19.3|STANDARD_DEVIATION|6.5||0.0002|TWO_SIDED|95.0|13.28|25.3|||Paired t-test|||Reader 1: Difference Between Non-contrast and OPTISON Dose Level 2||25.30|13.28|0.0002
72485427|NCT03740997|144498409|OTHER||Mean Difference (Net)|18.5|STANDARD_DEVIATION|11.68|<|0.0001|TWO_SIDED|95.0|13.47|23.57|||Paired t-test|||Reader 1: Difference Between Non-contrast and OPTISON Dose Level 2||23.57|13.47|<0.0001
72485428|NCT03740997|144498409|OTHER||Mean Difference (Net)|19.8|STANDARD_DEVIATION|3.06|<|0.0001|TWO_SIDED|95.0|16.62|23.05|||Paired t-test|||Reader 2: Difference Between Non-contrast and OPTISON Dose Level 1||23.05|16.62|<0.0001
72485429|NCT03740997|144498409|OTHER||Mean Difference (Net)|20.1|STANDARD_DEVIATION|13.38|<|0.0001|TWO_SIDED|95.0|14.16|26.03|||Paired t-test|||Reader 2: Difference Between Non-contrast and OPTISON Dose Level 1||26.03|14.16|<0.0001
72485430|NCT03740997|144498409|OTHER||Mean Difference (Net)|22.0|STANDARD_DEVIATION|2.77|<|0.0001|TWO_SIDED|95.0|19.44|24.56|||Paired t-test|||Reader 2: Difference Between Non-contrast and OPTISON Dose Level 2||24.56|19.44|<0.0001
72485431|NCT03740997|144498409|OTHER||Mean Difference (Net)|21.2|STANDARD_DEVIATION|13.34|<|0.0001|TWO_SIDED|95.0|15.45|26.99|||Paired t-test|||Reader 2: Difference Between Non-contrast and OPTISON Dose Level 2||26.99|15.45|<0.0001
72485432|NCT03740997|144498409|OTHER||Mean Difference (Net)|11.8|STANDARD_DEVIATION|9.35||0.0268|TWO_SIDED|95.0|2.02|21.64|||Paired t-test|||Reader 3: Difference Between Non-contrast and OPTISON Dose Level 1||21.64|2.02|0.0268
72485433|NCT03740997|144498409|OTHER||Mean Difference (Net)|16.1|STANDARD_DEVIATION|15.08|<|0.0001|TWO_SIDED|95.0|9.45|22.82|||Paired t-test|||Reader 3: Difference Between Non-contrast and OPTISON Dose Level 1||22.82|9.45|<0.0001
72485434|NCT03740997|144498409|OTHER||Mean Difference (Net)|12.1|STANDARD_DEVIATION|6.59||0.0028|TWO_SIDED|95.0|6.04|18.24|||Paired t-test|||Reader 3: Difference Between Non-contrast and OPTISON Dose Level 2||18.24|6.04|0.0028
72485435|NCT03740997|144498409|OTHER||Mean Difference (Net)|15.8|STANDARD_DEVIATION|13.37|<|0.0001|TWO_SIDED|95.0|10.04|21.61|||Paired t-test|||Reader 3: Difference Between Non-contrast and OPTISON Dose Level 2||21.61|10.04|<0.0001
72485436|NCT01829425|144498423|NON_INFERIORITY|The study design will use a non-inferiority design to compare the primary outcome (change in UUI episodes in the hypnotherapy versus pharmacotherapy groups). With respect to the outcome variable of percent reduction in UUI episodes as determined by bladder diaries, we will use a one-sided non- inferiority test at level alpha = 0.25 and a non-inferiority margin of 5%.|Difference in median % change between gr|5.0|||<|0.025|ONE_SIDED|95.0|5.0||||Exact Mann Whitney|Due dispersion, medians were calculated. Exact Mann Whitney test was used for this analysis.|Hypnotherapy - Pharmacotherapy. % difference in median % change in UUI episodes with lower bounds \> - 5% would be consistent with non-inferiority||||5|<.025
72485437|NCT01829425|144498424|NON_INFERIORITY|The study design will use a non-inferiority design to compare the primary outcome (change in UUI episodes in the hypnotherapy versus pharmacotherapy groups). With respect to the outcome variable of percent reduction in UUI episodes as determined by bladder diaries, we will use a one-sided non- inferiority test at level alpha = 0.25 and a non-inferiority margin of 5%. If|Difference in median % change between gr|5.0|||<|0.025|ONE_SIDED|95.0|5.0||||Exact Mann Whitney||||||5|<.025
72485438|NCT04178967|144498435|SUPERIORITY||Risk Difference (RD)|21.9||||4e-06|TWO_SIDED|95.0|14.2|29.6|||Cochran-Mantel-Haenszel|||||29.6|14.2|0.000004
72485439|NCT04178967|144498436|SUPERIORITY||Risk Difference (RD)|33.3|||<|1e-06|TWO_SIDED|95.0|24.4|42.2|||Cochran-Mantel-Haenszel|||||42.2|24.4|<0.000001
72485440|NCT04178967|144498437|SUPERIORITY||Risk Difference (RD)|0.7||||0.308463|TWO_SIDED|95.0|-0.3|1.7|||Cochran-Mantel-Haenszel|||||1.7|-0.3|0.308463
72485441|NCT04178967|144498438|SUPERIORITY||Risk Difference (RD)|8.1||||0.001607|TWO_SIDED|95.0|4.1|12.0|||Cochran-Mantel-Haenszel|||||12.0|4.1|0.001607
72485442|NCT04178967|144498439|SUPERIORITY||Risk Difference (RD)|21.9||||4e-06|TWO_SIDED|95.0|14.2|29.6|||Cochran-Mantel-Haenszel|||||29.6|14.2|0.000004
72485443|NCT04178967|144498440|SUPERIORITY||Risk Difference (RD)|20.7||||8e-06|TWO_SIDED|95.0|13.3|28.1|||Cochran-Mantel-Haenszel|||||28.1|13.3|0.000008
72485444|NCT04178967|144498441|SUPERIORITY||LS Mean Difference (Final Values)|-27.53|||<|1e-06|TWO_SIDED|95.0|-34.9|-20.2|||ANCOVA|||||-20.2|-34.9|<0.000001
72485445|NCT04178967|144498442|SUPERIORITY||Risk Difference (RD)|28.3|||<|1e-06|TWO_SIDED|95.0|20.0|36.5|||Cochran-Mantel-Haenszel|||||36.5|20.0|<0.000001
72485446|NCT04178967|144498443|SUPERIORITY||Risk Difference (RD)|29.7|||<|1e-06|TWO_SIDED|95.0|21.0|38.4|||Cochran-Mantel-Haenszel|||||38.4|21.0|<0.000001
72485447|NCT04178967|144498444|SUPERIORITY||LS Mean Difference (Final Values)|-33.57|||<|1e-06|TWO_SIDED|95.0|-41.2|-26.0|||ANCOVA|||||-26.0|-41.2|<0.000001
72512725|NCT00960934|144555974|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|-0.43||||0.901|TWO_SIDED|95.0|-2.03|1.17||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||1.17|-2.03|0.901
72567682|NCT01765582|144666901|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.68||||0.005|TWO_SIDED|90.0|0.53|0.88|||Log Rank|||Stratified by extent of metastatic disease (liver-limited disease vs. non-liver-limited disease) and tumor location (right vs. left) after correction post-randomization.||0.88|0.53|0.005
72485448|NCT04178967|144498445|SUPERIORITY||LS Mean Difference (Final Values)|-16.2|||<|1e-06|TWO_SIDED|95.0|-20.3|-12.0|||Mixed Models Analysis|||||-12.0|-20.3|<0.000001
72485449|NCT04178967|144498446|SUPERIORITY||Risk Difference (RD)|4.9||||0.022921|TWO_SIDED|95.0|1.4|8.4|||Cochran-Mantel-Haenszel|||||8.4|1.4|0.022921
72485450|NCT04178967|144498447|SUPERIORITY||LS Mean Difference (Final Values)|-4.9|||<|1e-06|TWO_SIDED|95.0|-6.3|-3.5|||ANCOVA|||||-3.5|-6.3|<0.000001
72485451|NCT04178967|144498448|SUPERIORITY||Risk Difference (RD)|32.9||||1e-06|TWO_SIDED|95.0|22.2|43.6|||Cochran-Mantel-Haenszel|||||43.6|22.2|0.000001
72485452|NCT04178967|144498449|SUPERIORITY||Risk Difference (RD)|33.0||||1e-06|TWO_SIDED|95.0|22.2|43.8|||Cochran-Mantel-Haenszel|||||43.8|22.2|0.000001
72485453|NCT04178967|144498450|SUPERIORITY||LS Mean Difference (Final Values)|-37.09|||<|1e-06|TWO_SIDED|95.0|-47.4|-26.8|||ANCOVA|||||-26.8|-47.4|<0.000001
72485454|NCT04178967|144498451|SUPERIORITY||LS Mean Difference (Final Values)|-0.7|||<|1e-06|TWO_SIDED|95.0|-0.9|-0.5|||ANCOVA|||||-0.5|-0.9|<0.000001
72485455|NCT04178967|144498452|SUPERIORITY||Risk Difference (RD)|18.9||||0.000571|TWO_SIDED|95.0|9.6|28.1|||Cochran-Mantel-Haenszel|||||28.1|9.6|0.000571
72485456|NCT04178967|144498453|SUPERIORITY||Risk Difference (RD)|0.4||||0.469221|TWO_SIDED|95.0|-0.4|1.2|||Cochran-Mantel-Haenszel|||||1.2|-0.4|0.469221
72485457|NCT04178967|144498454|SUPERIORITY||Risk Difference (RD)|2.7||||0.113194|TWO_SIDED|95.0|-0.1|5.4|||Cochran-Mantel-Haenszel|||||5.4|-0.1|0.113194
72485458|NCT04178967|144498455|SUPERIORITY||Risk Difference (RD)|13.2||||0.00023|TWO_SIDED|95.0|7.7|18.7|||Cochran-Mantel-Haenszel|||||18.7|7.7|0.000230
72485459|NCT04178967|144498456|SUPERIORITY||Risk Difference (RD)|0.4||||0.46816|TWO_SIDED|95.0|-0.4|1.3|||Cochran-Mantel-Haenszel|||||1.3|-0.4|0.468160
72485460|NCT04178967|144498457|SUPERIORITY||Risk Difference (RD)|2.9||||0.11577|TWO_SIDED|95.0|-0.1|5.8|||Cochran-Mantel-Haenszel|||||5.8|-0.1|0.115770
72485461|NCT04178967|144498458|SUPERIORITY||Risk Difference (RD)|14.2||||0.000252|TWO_SIDED|95.0|8.2|20.1|||Cochran-Mantel-Haenszel|||||20.1|8.2|0.000252
72485462|NCT04178967|144498459|SUPERIORITY||LS Mean Difference (Final Values)|-30.76|||<|1e-06|TWO_SIDED|95.0|-36.93|-24.59|||ANCOVA|||||-24.59|-36.93|<0.000001
72485463|NCT04178967|144498461|SUPERIORITY||Risk Difference (RD)|12.8||||0.238245|TWO_SIDED|95.0|-9.5|35.1|||Cochran-Mantel-Haenszel|||||35.1|-9.5|0.238245
72485464|NCT04178967|144498461|SUPERIORITY||Risk Difference (RD)|4.8||||0.612427|TWO_SIDED|95.0|-17.8|27.3|||Cochran-Mantel-Haenszel|||||27.3|-17.8|0.612427
72485465|NCT04178967|144498462|SUPERIORITY||Risk Difference (RD)|32.6||||0.033876|TWO_SIDED|95.0|2.6|62.5|||Cochran-Mantel-Haenszel|||||62.5|2.6|0.033876
72485466|NCT04178967|144498462|SUPERIORITY||Risk Difference (RD)|13.4||||0.407417|TWO_SIDED|95.0|-17.5|44.3|||Cochran-Mantel-Haenszel|||||44.3|-17.5|0.407417
72485467|NCT04178967|144498463|SUPERIORITY||Risk Difference (RD)|20.3||||0.159281|TWO_SIDED|95.0|-11.4|52.0|||Cochran-Mantel-Haenszel|||||52.0|-11.4|0.159281
72485468|NCT04178967|144498463|SUPERIORITY||Risk Difference (RD)|20.4||||0.16495|TWO_SIDED|95.0|-10.6|51.4|||Cochran-Mantel-Haenszel|||||51.4|-10.6|0.164950
72485469|NCT04178967|144498464|SUPERIORITY||Risk Difference (RD)|19.7||||0.179704|TWO_SIDED|95.0|-12.2|51.2|||Cochran-Mantel-Haenszel|||||51.2|-12.2|0.179704
72485470|NCT04178967|144498464|SUPERIORITY||Risk Difference (RD)|24.3||||0.08308|TWO_SIDED|95.0|-6.5|55.1|||Cochran-Mantel-Haenszel|||||55.1|-6.5|0.083080
72485471|NCT04178967|144498465|SUPERIORITY||LS Mean Difference (Final Values)|-6.29||||0.176748|TWO_SIDED|95.0|-15.46|2.87|||ANCOVA|||||2.87|-15.46|0.176748
72485472|NCT04178967|144498465|SUPERIORITY||LS Mean Difference (Final Values)|-6.25||||0.183151|TWO_SIDED|95.0|-15.48|2.99|||ANCOVA|||||2.99|-15.48|0.183151
72485473|NCT04178967|144498466|SUPERIORITY||LS Mean Difference (Final Values)|0.1||||1e-06|TWO_SIDED|95.0|0.1|0.1|||ANCOVA|||UK||0.1|0.1|0.000001
72485474|NCT04178967|144498466|SUPERIORITY||LS Mean Difference (Final Values)|0.1||||1e-06|TWO_SIDED|95.0|0.0|0.1|||ANCOVA|||US||0.1|0.0|0.000001
72485475|NCT04178967|144498467|SUPERIORITY||LS Mean Difference (Final Values)|4.5||||0.005304|TWO_SIDED|95.0|1.3|7.6|||ANCOVA|||||7.6|1.3|0.005304
72485476|NCT04178967|144498468|SUPERIORITY||LS Mean Difference (Final Values)|-6.0|||<|1e-06|TWO_SIDED|95.0|-7.7|-4.3|||Mixed Models Analysis|||||-4.3|-7.7|<0.000001
72485477|NCT04178967|144498469|SUPERIORITY||LS Mean Difference (Final Values)|-2.91||||0.241275|TWO_SIDED|95.0|-7.85|2.03|||ANCOVA|||||2.03|-7.85|0.241275
72485478|NCT04178967|144498470|SUPERIORITY||LS Mean Difference (Final Values)|-2.74||||0.000116|TWO_SIDED|95.0|-4.12|-1.36|||ANCOVA|||||-1.36|-4.12|0.000116
72512726|NCT00960934|144555974|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|-0.51||||0.901|TWO_SIDED|95.0|-2.18|1.17||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||1.17|-2.18|0.901
72512727|NCT00960934|144555974|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|-0.52||||0.901|TWO_SIDED|95.0|-2.17|1.13||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||1.13|-2.17|0.901
72512728|NCT00960934|144555974|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|0.03||||0.997|TWO_SIDED|95.0|-1.29|1.35||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||1.35|-1.29|0.997
72512729|NCT00960934|144555974|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|-0.04||||0.997|TWO_SIDED|95.0|-1.51|1.43||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||1.43|-1.51|0.997
72512730|NCT00960934|144555975|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|-0.37||||0.979|TWO_SIDED|95.0|-2.73|1.99||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||1.99|-2.73|0.979
72576914|NCT00261443|144680714|SUPERIORITY_OR_OTHER_LEGACY|||||||0.174||95.0|||||Wilcoxon Rank Sum Test|||Week 52 LOCF Treatment Comparison; Aripiprazole/Placebo||||0.174
72485479|NCT04178967|144498471|SUPERIORITY||LS Mean Difference (Final Values)|-1.1||||0.645132|TWO_SIDED|95.0|-5.86|3.67|||ANCOVA|||||3.67|-5.86|0.645132
72485480|NCT04178967|144498472|SUPERIORITY||LS Mean Difference (Final Values)|-2.75||||3.1e-05|TWO_SIDED|95.0|-4.03|-1.47|||ANCOVA|||||-1.47|-4.03|0.000031
72485481|NCT04178967|144498473|SUPERIORITY||LS Mean Difference (Final Values)|0.0||||0.974417|TWO_SIDED|95.0|-0.27|0.26|||ANCOVA|||||0.26|-0.27|0.974417
72485482|NCT04178967|144498474|SUPERIORITY||LS Mean Difference (Final Values)|-4.2||||0.084769|TWO_SIDED|95.0|-9.1|0.6|||Mixed Models Analysis|||||0.6|-9.1|0.084769
72485483|NCT00223678|144498478|SUPERIORITY_OR_OTHER|||||||0.849|||||||Log Rank|||||||0.849
72485484|NCT01667107|144498542|SUPERIORITY_OR_OTHER||Spearman rank correlation coefficient|0.53||||0.139|||||||Spearman rank correlation|||Spearman rank correlation between concurrent BAL and serum posaconazole concentrations||||0.139
72485485|NCT01667107|144498542|SUPERIORITY_OR_OTHER||Spearman rank correlation coefficient|0.59||||0.057|||||||Spearman rank correlation|||Spearman rank correlation between concurrent BAL and serum posaconazole concentrations||||0.057
72485486|NCT00088907|144498576|SUPERIORITY_OR_OTHER|||||||0.6|TWO_SIDED||||||Log Rank|||||||0.60
72485487|NCT00088907|144498577|SUPERIORITY_OR_OTHER|||||||0.19|||||||Log Rank|||||||0.19
72485488|NCT03426787|144498587|SUPERIORITY||Mean Difference (Final Values)|-12.30216|||<|0.001|TWO_SIDED|95.0|-18.95|-5.6531|||t-test, 2 sided|||||-5.6531|-18.95|<0.001
72485489|NCT03426787|144498588|SUPERIORITY||Mean Difference (Final Values)|-0.4717||||0.0463|TWO_SIDED|95.0|-0.9355|-0.00793|||t-test, 2 sided|||||-0.00793|-0.9355|0.0463
72485490|NCT03426787|144498589|SUPERIORITY||Median Difference (Final Values)|-1.936|||>|0.05|TWO_SIDED|95.0|-7.4086|3.5365|||t-test, 2 sided|||||3.5365|-7.4086|>0.05
72485491|NCT05395104|144498662|OTHER|Ratio = Geometric least squares mean (test)/geometric least squares mean (reference)|Ratio|1.0865|||||TWO_SIDED|90.0|0.9724|1.2141||||||Midazolam + Cefiderocol: single 5-mg dose of midazolam + 2 g cefiderocol (Day 15)||1.2141|0.9724|
72485492|NCT05395104|144498664|OTHER|Ratio = Geometric least squares mean (test)/geometric least squares mean (reference)|Ratio|1.1174|||||TWO_SIDED|90.0|0.9784|1.2762||||||Midazolam + Cefiderocol: single 5-mg dose of midazolam + 2 g cefiderocol (Day 15)||1.2762|0.9784|
72485493|NCT05395104|144498665|OTHER|Ratio = Geometric least squares mean (test)/geometric least squares mean (reference)|Ratio|1.1239|||||TWO_SIDED|90.0|0.9887|1.2776||||||Midazolam + Cefiderocol: single 5-mg dose of midazolam + 2 g cefiderocol (Day 15)||1.2776|0.9887|
72512731|NCT00960934|144555975|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|1.92||||0.363|TWO_SIDED|95.0|-1.1|4.95||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||4.95|-1.10|0.363
72512732|NCT00960934|144555975|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|0.4||||0.979|TWO_SIDED|95.0|-2.18|2.98||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||2.98|-2.18|0.979
72485494|NCT00789750|144498682|OTHER||Mean Difference (Final Values)|-0.32|STANDARD_ERROR_OF_MEAN|0.084|<|0.001|TWO_SIDED|95.0|-0.49|-0.16|||ANCOVA|||Treatment difference = Colesevelam - Placebo||-0.16|-0.49|<0.001
72485495|NCT00789750|144498683|OTHER||Mean Difference (Final Values)|-0.17|STANDARD_ERROR_OF_MEAN|0.037|<|0.001|TWO_SIDED|95.0|-0.24|-0.1|||ANCOVA|||Treatment difference = Colesevelam - Placebo||-0.10|-0.24|<0.001
72485496|NCT00789750|144498684|OTHER||Mean Difference (Final Values)|-0.21|STANDARD_ERROR_OF_MEAN|0.056||0.0002|TWO_SIDED|95.0|-0.32|-0.1|||ANCOVA|||Treatment difference = Colesevelam - Placebo||-0.10|-0.32|0.0002
72485497|NCT00789750|144498685|OTHER||Mean Difference (Final Values)|-0.36|STANDARD_ERROR_OF_MEAN|0.077|<|0.001|TWO_SIDED|95.0|-0.51|-0.2|||ANCOVA|||Treatment difference = Colesevelam - Placebo||-0.20|-0.51|<0.001
72485498|NCT00789750|144498686|OTHER|||||||0.012|||||||Cochran-Mantel-Haenszel|||||||0.012
72485499|NCT00789750|144498687|OTHER||Mean Difference (Final Values)|-14.7|STANDARD_ERROR_OF_MEAN|3.68|<|0.0001|TWO_SIDED|95.0|-21.93|-7.49|||ANCOVA|||Treatment difference = Colesevelam - Placebo||-7.49|-21.93|<0.0001
72485500|NCT00789750|144498688|OTHER|||||||0.0003|||||||Cochran-Mantel-Haenszel|||||||0.0003
72485501|NCT00789750|144498689|OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
72485502|NCT00789750|144498690|OTHER|||||||0.132|||||||Cochran-Mantel-Haenszel|||||||0.132
72485503|NCT00789750|144498691|OTHER||||||<|0.001|||||||ANCOVA|||||||<0.001
72485504|NCT00789750|144498692|OTHER||Mean Difference (Final Values)|-16.4|STANDARD_ERROR_OF_MEAN|2.15|<|0.001|TWO_SIDED|95.0|-20.62|-12.18|||ANCOVA|||Treatment difference = Colesevelam - Placebo||-12.18|-20.62|<0.001
72485505|NCT00789750|144498693|OTHER||Mean Difference (Final Values)|1.8|STANDARD_ERROR_OF_MEAN|1.31||0.1652|TWO_SIDED|95.0|-0.75|4.39|||ANCOVA|||Treatment difference = Colesevelam - Placebo||4.39|-0.75|0.1652
72485506|NCT00789750|144498694|OTHER||Mean Difference (Final Values)|-9.8|STANDARD_ERROR_OF_MEAN|1.85|<|0.0001|TWO_SIDED|95.0|-13.44|-6.16|||ANCOVA|||Treatment difference = Colesevelam - Placebo||-6.16|-13.44|<0.0001
72485507|NCT00789750|144498695|OTHER||Median Difference (Final Values)|11.3|STANDARD_ERROR_OF_MEAN|67.01||0.0004|TWO_SIDED|95.0|5.3|17.5|||ANCOVA||The treatment difference and its 95% confidence interval are estimated using the Hodges-Lehmann estimator and Moses method. The parameter dispersion Type is actually IQR of the Median Difference.|Treatment difference = Colesevelam - Placebo||17.5|5.3|0.0004
72485508|NCT00789750|144498696|OTHER||Mean Difference (Final Values)|3.4|STANDARD_ERROR_OF_MEAN|0.93||0.0003|TWO_SIDED|95.0|1.58|5.23|||ANCOVA|||Treatment difference = Colesevelam - Placebo||5.23|1.58|0.0003
72512733|NCT00960934|144555975|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|-0.49||||0.979|TWO_SIDED|95.0|-3.27|2.3||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||2.30|-3.27|0.979
72512734|NCT00960934|144555975|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|0.51||||0.979|TWO_SIDED|95.0|-2.34|3.37||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||3.37|-2.34|0.979
72485509|NCT00789750|144498697|OTHER||Mean Difference (Final Values)|-8.8|STANDARD_ERROR_OF_MEAN|1.52|<|0.0001|TWO_SIDED|95.0|-11.75|-5.78|||ANCOVA|||Treatment difference = Colesevelam - Placebo||-5.78|-11.75|<0.0001
72485510|NCT00789750|144498698|OTHER||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|1.77||0.7286|TWO_SIDED|95.0|-4.1|2.9|||ANCOVA|||Treatment difference = Colesevelam - Placebo||2.9|-4.1|0.7286
72485511|NCT00789750|144498699|OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.11||0.0653|TWO_SIDED|95.0|-0.4|0.0|||ANCOVA|||Treatment difference = Colesevelam - Placebo||0.0|-0.4|0.0653
72485512|NCT00789750|144498700|OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.73||0.8862|TWO_SIDED|95.0|-1.5|1.3|||ANCOVA|||Treatment difference = Colesevelam - Placebo||1.3|-1.5|0.8862
72485513|NCT03933397|144498708|SUPERIORITY|||||||0.909|||||||Regression, Linear|||||||0.909
72485514|NCT01572675|144498744|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||p-student|||Group comparison (Arcoxia® \[Initiation\] vs Arcoxia® \[Renewal\]) for duration of prescription at enrollment||||<0.001
72485515|NCT01572675|144498744|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||p-student|||Group comparison (Celebrex® \[Initiation\] vs Celebrex® \[Renewal\]) for duration of prescription at enrollment||||<0.001
72485516|NCT01572675|144498749|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Chi-squared|||Duration of treatment comparison (More than one year vs Up to thirty days) for intermittent selective COX-2 inhibitor use. The analysis assessed whether long-term treatment was more correlated with intermittent selective COX-2 inhibitor use compared to short-term treatment.||||<0.001
72485517|NCT01572675|144498752|SUPERIORITY_OR_OTHER_LEGACY|||||||0.104|||||||Chi-squared|||Group comparison (Arcoxia® vs Celebrex®) for controlled BP (SBP \<140 mmHg and DBP \<90 mmHg) at study entry||||0.104
72485518|NCT01572675|144498752|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0049|||||||Chi-squared|||Group comparison (Arcoxia® \[Initiation\] vs Arcoxia® \[Renewal\]) for controlled BP (SBP \<140 mmHg and DBP \<90 mmHg) at study entry||||0.0049
72485519|NCT01572675|144498752|SUPERIORITY_OR_OTHER_LEGACY|||||||0.618|||||||Chi-squared|||Group comparison (Celebrex® \[Initiation\] vs Celebrex® \[Renewal\]) for controlled BP (SBP \<140 mmHg and DBP \<90 mmHg) at study entry||||0.618
72485520|NCT01572675|144498753|SUPERIORITY_OR_OTHER_LEGACY|||||||0.012|||||||Chi-squared|||Group comparison (Arcoxia® \[Initiation\] vs Arcoxia® \[Renewal\]) for medical history of arterial hypertension||||0.012
72485521|NCT01572675|144498753|SUPERIORITY_OR_OTHER_LEGACY|||||||0.175|||||||Chi-squared|||Group comparison (Celebrex® \[Initiation\] vs Celebrex® \[Renewal\]) for medical history of arterial hypertension||||0.175
72485522|NCT01572675|144498755|SUPERIORITY_OR_OTHER_LEGACY|||||||0.701|||||||Chi-squared|||Group comparison (Arcoxia® \[Initiation\] vs Arcoxia® \[Renewal\]) for significant past treatments||||0.701
72485523|NCT01572675|144498755|SUPERIORITY_OR_OTHER_LEGACY|||||||0.007|||||||Chi-squared|||Group comparison (Celebrex® \[Initiation\] vs Celebrex® \[Renewal\]) for significant past treatments||||0.007
72485524|NCT01572675|144498755|SUPERIORITY_OR_OTHER_LEGACY|||||||0.955|||||||Chi-squared|||Group comparison (Arcoxia® vs Celebrex®) for significant past treatments||||0.955
72485525|NCT01572675|144498758|SUPERIORITY_OR_OTHER_LEGACY|||||||0.049|||||||Fisher Exact|||Group comparsion (Arcoxia® vs Celebrex®) for previous treatment with other agents prior to initiation of Arcoxia® and Celebrex® for the main study indications||||0.049
72485526|NCT01572675|144498761|SUPERIORITY_OR_OTHER_LEGACY|||||||0.165|||||||Chi-squared|||Group comparsion (Arcoxia® vs Celebrex®) of adverse events experienced during treatment||||0.165
72485527|NCT01660451|144498773|SUPERIORITY_OR_OTHER_LEGACY||Response rate|45.45||||0.0001|TWO_SIDED|90.0|30.49|61.06||0.0001|Exact binomial test|||Response rate was statistically compared by exact binomial test if higher than 5%.||61.06|30.49|0.0001
72485528|NCT01660451|144498773|SUPERIORITY_OR_OTHER_LEGACY||Response rate|27.08||||0.0001|TWO_SIDED|90.0|16.83|39.57||0.0001|Exact binominal test|P-value was based on the original patients in the aggressive arm (for the first 34 patients), not including the additional recruited patients.||Response rate was statistically compared by exact binomial test if higher than 5%.||39.57|16.83|0.0001
72485529|NCT01660451|144498774|SUPERIORITY_OR_OTHER_LEGACY||Response rate|59.15|||<|0.0001|TWO_SIDED|95.0|50.6|67.32||0.001|Exact binominal test|||Response rate was statistically compared by exact binomial test if higher than 40%.||67.32|50.60|<0.0001
72485530|NCT01660451|144498775|SUPERIORITY_OR_OTHER_LEGACY||Response rate|46.88||||0.0001|TWO_SIDED|90.0|31.54|62.66||0.0001|Exact binominal test|||Response rate was statistically compared by exact binomial test if higher than 5%.||62.66|31.54|0.0001
72485531|NCT01660451|144498775|SUPERIORITY_OR_OTHER_LEGACY||Response rate|31.25||||0.0001|TWO_SIDED|90.0|20.35|43.97||0.0001|Exact binominal test|||Response rate was statistically compared by exact binomial test if higher than 5%.||43.97|20.35|0.0001
72485532|NCT01660451|144498776|SUPERIORITY_OR_OTHER_LEGACY||Response rate|51.41||||0.0039|TWO_SIDED|95.0|42.88|59.87||0.01|Exact binominal test|||Response rate was statistically compared by exact binomial test if higher than 40%.||59.87|42.88|0.0039
72485533|NCT01660451|144498787|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehmann-estimate|1.0|||||TWO_SIDED|95.0|0.5|2.5||||||Hodges-Lehmann-estimate was used to calculate change to Week 16 and 95% confidence interval.||2.5|0.5|
72485534|NCT01660451|144498788|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehmann-estimate|0.5|||||TWO_SIDED|95.0|-0.7|3.2||||||Hodges-Lehmann-estimate was used to calculate change to Week 16 and 95% confidence interval.||3.2|-0.7|
72485535|NCT02281357|144498789|SUPERIORITY|The null hypothesis was that the average percentage change in OCS dose on tralokinumab was equal to the average percentage change in OCS dose on placebo.|LS Mean difference|-7.78||||0.271|TWO_SIDED|95.0|-21.7|6.15|||ANCOVA|The analysis of covariance (ANCOVA) model utilised a sandwich estimator for the variance.|The model included treatment group as a fixed effect and baseline OCS dose as a continuous covariate. No interaction terms were included in the model. All group comparisons from the ANCOVA model were based on Type III sums of squares.|Comparison of percent change from baseline in OCS dose: tralokinumab vs placebo.||6.15|-21.70|0.271
72485536|NCT02281357|144498790|SUPERIORITY||Odds Ratio (OR)|1.33||||0.442|TWO_SIDED|95.0|0.65|2.73|||Regression, Logistic|The model included treatment group as a fixed effect and baseline OCS dose as a continuous covariate.||Comparison of OCS dose ≤5.0 mg: tralokinumab vs placebo.||2.73|0.65|0.442
72485537|NCT02281357|144498791|SUPERIORITY||Odds Ratio (OR)|1.38||||0.356|TWO_SIDED|95.0|0.7|2.74|||Regression, Logistic|The model included treatment group as a fixed effect and baseline OCS dose as a continuous covariate.||Comparison of ≥50% reduction in OCS dose: tralokinumab vs placebo.||2.74|0.70|0.356
72485538|NCT02281357|144498792|SUPERIORITY||Rate Ratio|0.8||||0.186|TWO_SIDED|95.0|0.57|1.12|||Negative binomial||Treatment group, OCS dose at baseline, and number of exacerbations in the previous year are included in the model as covariates.|Comparison of AAER: tralokinumab vs placebo.||1.12|0.57|0.186
72485539|NCT05314712|144498793|OTHER|Linear Mixed Model (repeated measures model) of sleep trouble||||||||||||There was no hypothesis test. All participants received the 7-week intervention - there was no comparison group. A variable selection approach (AIC) was used for including the final variables in the model.||||Since all participants in this pilot study received in the intervention and data was collected pre and post intervention, there was no hypothesis test. Under the assumption that the likert scale data was treated as continuous, the data was analyzed using a linear mixed model. Variables in final model were included after variable selection (details below).|Using an exhaustive search of all models (dredge) that could be formed from predictor variables partner sleep rating, perceived stress, DASS scale, 8-item diet scale, amount of screen time, amount of time between bed time and wake time, amount of time to fall asleep, hours of sleep, sleep rating score, indicator variable if the child played outside, bed time, and wake time, adult height in inches, adult BMI, adult's highest education attained, the number of children in the household, grade of the child, child height in inches, child BMI, age of the child, and gender of the child, requiring the the timing of the survey be in the model, and accounting for repeated measurements over time, using AIC as the selection criterion we looked for the model with the smallest AIC value. The final sleep trouble model included the covariates timing of survey, DASS scale, and indicator variable if child played outside.|||
72512735|NCT00960934|144555976|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|19.77||||0.02|TWO_SIDED|95.0|2.26|37.46||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||37.46|2.26|0.020
72512736|NCT00960934|144555976|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|10.08||||0.357|TWO_SIDED|95.0|-6.16|26.41||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||26.41|-6.16|0.357
72512737|NCT00960934|144555976|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|-2.83||||0.642|TWO_SIDED|95.0|-14.81|9.14||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||9.14|-14.81|0.642
72512738|NCT00960934|144555976|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|8.44||||0.434|TWO_SIDED|95.0|-7.09|24.04||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||24.04|-7.09|0.434
72512739|NCT00960934|144555976|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|5.72||||0.579||95.0|-8.62|20.1||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||20.10|-8.62|0.579
72576915|NCT00261443|144680714|SUPERIORITY_OR_OTHER_LEGACY|||||||0.527||95.0|||||Wilcoxon Rank Sum Test|||Highest Value Treatment Comparison; Aripiprazole/Placebo||||0.527
72402649|NCT01480076|144311689|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Overall, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 physical score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
72402650|NCT01480076|144311689|SUPERIORITY_OR_OTHER|||||||0.2949|||||||mixed effect model|||Overall, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 physical score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.2949
72402651|NCT01480076|144311689|SUPERIORITY_OR_OTHER||difference of LS means|-8.1|STANDARD_ERROR_OF_MEAN|1.93|<|0.0001|TWO_SIDED||||||mixed effect model|||Overall, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 physical score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
72402652|NCT01480076|144311689|SUPERIORITY_OR_OTHER||difference of LS means|-9.0|STANDARD_ERROR_OF_MEAN|3.16||0.0046|TWO_SIDED||||||mixed effect model|||Overall, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 physical score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0046
72402653|NCT01480076|144311689|SUPERIORITY_OR_OTHER||difference of LS means|-12.6|STANDARD_ERROR_OF_MEAN|1.07|<|0.0001|TWO_SIDED||||||mixed effect model|||Month 3, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 physical score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
72512740|NCT00960934|144555977|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|34.26|||<|0.001|TWO_SIDED|95.0|15.27|53.56||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis|||||53.56|15.27|<0.001
72512741|NCT00960934|144555977|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|20.57||||0.014|TWO_SIDED|95.0|3.28|38.02||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis|||||38.02|3.28|0.014
72402654|NCT01480076|144311689|SUPERIORITY_OR_OTHER|||||||0.502|||||||mixed effect model|||Month 3, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 physical score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.5020
72402655|NCT01480076|144311689|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 3, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 physical score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
72402656|NCT01480076|144311689|SUPERIORITY_OR_OTHER|||||||0.2157|||||||mixed effect model|||Month 3, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 physical score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.2157
72402657|NCT01480076|144311689|SUPERIORITY_OR_OTHER||difference of LS means|-11.2|STANDARD_ERROR_OF_MEAN|2.0|<|0.0001|TWO_SIDED||||||mixed effect model|||Month 3, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 physical score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
72485540|NCT05314712|144498793|OTHER|Mixed effects linear regression model of hours slept||||||||||||There was no hypothesis test. All participants received the 7-week intervention - there was no comparison group. A variable selection approach (AIC) was used for including the final variables in the model.||||Since all participants in this pilot study received in the intervention and data was collected pre and post intervention, there was no hypothesis test. The data was analyzed using a mixed effects linear regression model. Variables in final model were included after variable selection (details below).|Using an exhaustive search of all models (dredge) that could be formed from predictor variables partner sleep rating, perceived stress, DASS scale, 8-item diet scale, amount of screen time, amount of time between bed time and wake time, amount of time to fall asleep, hours of sleep, sleep rating score, indicator variable if the child played outside, bed time, and wake time, adult height in inches, adult BMI, adult's highest education attained, the number of children in the household, grade of the child, child height in inches, child BMI, age of the child, and gender of the child, requiring the the timing of the survey be in the model, and accounting for repeated measurements over time, using AIC as the selection criterion we looked for the model with the smallest AIC value. The final model for hours slept included the covariates number of children in the household, indicator variable if child played outside, and baseline hours slept.|||
72512742|NCT00960934|144555977|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|9.97||||0.307|TWO_SIDED|95.0|-5.69|25.7||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis|||||25.70|-5.69|0.307
72576916|NCT00261443|144680714|SUPERIORITY_OR_OTHER_LEGACY|||||||0.753||95.0|||||Wilcoxon Rank Sum Test|||Lowest Value Treatment Comparison; Aripiprazole/Placebo||||0.753
72485541|NCT01499953|144498794|NON_INFERIORITY|The hypotheses for non-inferiority test using ∆=4.5% for the difference between incidence rates were H0: πrivaroxaban-πfondaparinux ≥ 4.5%, H1: πrivaroxaban-πfondaparinux \< 4.5% where πfondaparinux and πrivaroxaban were the incidence rates of CIAC confirmed VTE complications up to Day 45 in the treatment groups. Rejection of the null hypothesis would have concluded that rivaroxaban was not inferior to fondaparinux. To calculate the p-value, an asymptotic test for non-inferiority was used.||||||0.0252|||||||asymptotic test for non-inferiority|||||||0.0252
72485542|NCT00823303|144498816|NON_INFERIORITY_OR_EQUIVALENCE|On the basis of prior published reports, we estimated a 5% rate of hypercalcemia with paricalcitol and a 30% rate with calcitriol. To have a 90% power to detect a difference at the P=0.05 confidence level, 42 patients per group were needed. Assuming a 30% dropout rate over the course of the study, we planned to randomize 110 patients.||||||0.36|||||||Fisher Exact|||||||0.36
72485543|NCT00523718|144498927|SUPERIORITY_OR_OTHER_LEGACY|||||||0.24|TWO_SIDED||||||Chi-squared|||||||.24
72485544|NCT02060383|144498931|OTHER|There was no formal hypothesis testing planned in this study.|Mean Difference (Net)|-0.28|STANDARD_ERROR_OF_MEAN|0.18|||TWO_SIDED|95.0|-0.63|0.08|||||Difference of adjusted mean change in HbA1c between the two arms based on an ANOVA model with treatment (Incretin, Insulin) and randomization stratification factors (Cushing's vs. Acromegaly; baseline HbA1c \<7% vs ≥7%) as fixed effects.|All Patients||0.08|-0.63|
72485545|NCT02060383|144498931|OTHER|There was no formal hypothesis testing planned in this study.|Mean Difference (Net)|-0.01|STANDARD_ERROR_OF_MEAN|0.45|||TWO_SIDED|95.0|-0.96|0.95|||||Difference of adjusted mean change in HbA1c between the two arms based on an ANOVA model with treatment (Incretin, Insulin) and randomization stratification factors (baseline HbA1c \<7% vs ≥7%) as fixed effects.|Cushing's Disease||0.95|-0.96|
72485546|NCT02060383|144498931|OTHER|There was no formal hypothesis testing planned in this study.|Mean Difference (Net)|-0.36|STANDARD_ERROR_OF_MEAN|0.19|||TWO_SIDED|95.0|-0.74|0.02|||||Difference of adjusted mean change in HbA1c between the two arms based on an ANOVA model with treatment (Incretin, Insulin) and randomization stratification factors (baseline HbA1c \<7% vs ≥7%) as fixed effects.|Acromegaly||0.02|-0.74|
72485547|NCT00395863|144498946|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Reader 1|wilcoxon signed-rank test|||||||< 0.0001
72485548|NCT00395863|144498946|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Reader 2|wilcoxon signed-rank test|||||||<0.0001
72485549|NCT00395863|144498946|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Reader 3|wilcoxon signed-rank test|||||||< 0.0001
72485550|NCT00395863|144498947|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0001||||||Reader 1|wilcoxon signed-rank test|||||||0.0001
72485551|NCT00395863|144498947|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001||||||Reader 2|wilcoxon signed-rank test|||||||0.001
72485552|NCT00395863|144498947|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0002||||||Reader 3|wilcoxon signed-rank test|||||||0.0002
72485553|NCT00395863|144498948|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0||||Reader 1|wilcoxon signed-rank test|||||||<0.0001
72485554|NCT00395863|144498948|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Reader 2|wilcoxon signed-rank test|||||||<0.0001
72485555|NCT00395863|144498948|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Reader 3|wilcoxon signed-rank test|||||||<0.0001
72485556|NCT00395863|144498949|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.22|STANDARD_DEVIATION|0.22|<|0.0001||95.0|0.14|0.3||Mean difference of MultiHance minus Magnevist for change from baseline|t-test, 2 sided|||||0.30|0.14|<0.0001
72485557|NCT00395863|144498950|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.3|STANDARD_DEVIATION|0.2|<|0.0001||95.0|0.22|0.38||Mean difference of Multihance minus Magnevist for change from baseline|t-test, 2 sided|||||0.38|0.22|<0.0001
72485558|NCT00395863|144498951|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.25|STANDARD_DEVIATION|0.19|<|0.0001||95.0|0.18|0.33||Mean difference of Multihance minus Magnevist for change from baseline|t-test, 2 sided|||||0.33|0.18|<0.0001
72485559|NCT00395863|144498952|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|40.99|STANDARD_DEVIATION|59.78||0.0062||95.0|20.72|61.26||Mean difference of Multihance minus Magnevist for change from baseline|t-test, 2 sided|||||61.26|20.72|0.0062
72512743|NCT00960934|144555977|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|9.02||||0.307|TWO_SIDED|95.0|-5.85|23.95||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis|||||23.95|-5.85|0.307
72512744|NCT00960934|144555977|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|-0.5||||0.937|TWO_SIDED|95.0|-12.92|11.92||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis|||||11.92|-12.92|0.937
72512745|NCT00960934|144555978|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|19.19|||<|0.001|TWO_SIDED|95.0|7.42|31.02||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||31.02|7.42|<0.001
72512746|NCT00960934|144555978|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|23.38|||<|0.001|TWO_SIDED|95.0|11.02|35.82||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||35.82|11.02|<0.001
72485560|NCT00395863|144498953|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|30.95|STANDARD_DEVIATION|48.64||0.0027||95.0|16.57|45.33||Mean difference of Multihance minus Magnevist for change from baseline|t-test, 2 sided|||||45.33|16.57|0.0027
72485561|NCT00395863|144498954|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|25.04|STANDARD_DEVIATION|37.37||0.02||95.0|12.41|37.67||Mean difference of Multihance minus Magnevist for change from baseline|t-test, 2 sided|||||37.67|12.41|0.02
72512747|NCT00960934|144555978|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|10.45||||0.061|TWO_SIDED|95.0|-0.37|21.3||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||21.30|-0.37|0.061
72512748|NCT00960934|144555978|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|6.31||||0.283|TWO_SIDED|95.0|-3.81|16.45||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||16.45|-3.81|0.283
72485562|NCT00395863|144498955|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|32.77|STANDARD_DEVIATION|48.51||0.0019||95.0|14.28|51.25||Mean difference of Multihance minus Magnevist|t-test, 2 sided|||||51.25|14.28|0.0019
72485563|NCT00395863|144498956|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|33.61|STANDARD_DEVIATION|43.16||0.0008||95.0|16.75|50.47||Mean difference of Multihance minus Magnevist|t-test, 2 sided|||||50.47|16.75|0.0008
72485564|NCT00395863|144498957|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|33.72|STANDARD_DEVIATION|48.5||0.0026||95.0|14.63|52.81||Mean difference of Multihance minus Magnevist|t-test, 2 sided|||||52.81|14.63|0.0026
72485565|NCT02592551|144498960|OTHER||Median Difference (Final Values)|8.6||||0.109|TWO_SIDED||||||Wilcoxon signed rank test|||Compare in ratios of intratumoral cytotoxic T cells to regulatory T cells (CD8/Treg) between pre and post of MEDI4736+Tremelimumab||||0.109
72485566|NCT02592551|144498961|OTHER|Compare the tissue biomarker for the immune response of ICOS+ CD4 T cells to before and after MEDI-4736 and Tremelimumab||||||1|||||||Wilcoxon signed rank test|||||||1
72485567|NCT02592551|144498962|OTHER|||||||0.461|||||||Wilcoxon signed rank test|||Compare tumor expression programmed death-ligand 1 (PD-L1) before and after treatment with combination MEDI-4736 and Tremelimumab||||0.461
72485568|NCT02592551|144498963|OTHER|||||||0.954|||||||Wilcoxon (Mann-Whitney)|||Compare tissue biomarker immune response of CD8 and Treg (ratio of CD8/treg) after MEDI-4736 and Tremelimumab, and after MEDI4736 alone||||0.954
72485569|NCT02592551|144498964|OTHER|||||||0.799|||||||Wilcoxon (Mann-Whitney)|||Compare tissue biomarker immune response of CD8 and Treg(ratio of CD8/Treg) after MEDI-4736 and Tremelimumab, and at day 1 of untread control group||||0.799
72485570|NCT02592551|144498967|OTHER|||||||0.418|||||||Wilcoxon (Mann-Whitney)|||Compare tumor expression programmed death-ligand 1 (PD-L1) after combination therapy (MEDI-4736 and Tremelimumab) and after MEDI-4736 alone||||0.418
72485571|NCT02592551|144498968|OTHER|||||||0.932|||||||Wilcoxon (Mann-Whitney)|||Compare tumor expression programmed death-ligand 1 (PD-L1) after combination therapy (MEDI-4736 and Tremelimumab) and before and at day 1 of untreated||||0.932
72485572|NCT02137512|144498996|SUPERIORITY|No adjustments were made for multiple comparisons.|||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
72485573|NCT02137512|144498996|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
72485574|NCT02137512|144498996|SUPERIORITY|||||||0.31||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.31
72485575|NCT02137512|144498997|SUPERIORITY|||||||0.002||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.002
72485576|NCT02137512|144498997|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
72485577|NCT02137512|144498997|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
72485578|NCT02137512|144498998|SUPERIORITY|||||||0.1||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.10
72485579|NCT02137512|144498998|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
72485580|NCT02137512|144498998|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
72485581|NCT02137512|144498999|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
72485582|NCT02137512|144498999|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
72485583|NCT02137512|144498999|SUPERIORITY|||||||0.91||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.91
72485584|NCT02137512|144499000|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
72485585|NCT02137512|144499000|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
72485586|NCT02137512|144499000|SUPERIORITY|||||||0.2||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.20
72485587|NCT02137512|144499001|SUPERIORITY|||||||0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.001
72485588|NCT02137512|144499001|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
72485589|NCT02137512|144499001|SUPERIORITY|||||||0.49||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.49
72512749|NCT00960934|144555978|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|5.46||||0.283|TWO_SIDED|95.0|-3.39|14.31||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||14.31|-3.39|0.283
72512750|NCT00960934|144555979|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|56.77|||<|0.001|TWO_SIDED|95.0|37.62|76.35||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis|||||76.35|37.62|<.001
72485590|NCT02137512|144499002|SUPERIORITY|||||||0.009||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.009
72485591|NCT02137512|144499002|SUPERIORITY|||||||0.14||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.14
72485592|NCT02137512|144499002|SUPERIORITY|||||||0.06||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.06
72485593|NCT02137512|144499003|SUPERIORITY|||||||0.002||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.002
72485594|NCT02137512|144499003|SUPERIORITY|||||||0.03||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.03
72485595|NCT02137512|144499003|SUPERIORITY|||||||0.18||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.18
72485596|NCT02137512|144499004|SUPERIORITY|||||||0.07||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.07
72485597|NCT02137512|144499004|SUPERIORITY|||||||0.54||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.54
72485598|NCT02137512|144499004|SUPERIORITY|||||||0.07||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.07
72485599|NCT02137512|144499005|SUPERIORITY|||||||0.005||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.005
72485600|NCT02137512|144499005|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
72402658|NCT01480076|144311689|SUPERIORITY_OR_OTHER||difference of LS means|-10.0|STANDARD_ERROR_OF_MEAN|3.3||0.0026|TWO_SIDED||||||mixed effect model|||Month 3, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 physical score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0026
72402659|NCT01480076|144311689|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 6, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 physical score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
72402660|NCT01480076|144311689|SUPERIORITY_OR_OTHER|||||||0.3435|||||||mixed effect model|||Month 6, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 physical score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.3435
72402661|NCT01480076|144311689|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 6, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 physical score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
72402662|NCT01480076|144311689|SUPERIORITY_OR_OTHER|||||||0.1357|||||||mixed effect model|||Month 6, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 physical score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.1357
72402663|NCT01480076|144311689|SUPERIORITY_OR_OTHER||difference of LS means|-7.8|STANDARD_ERROR_OF_MEAN|2.22||0.0004|TWO_SIDED||||||mixed effect model|||Month 6, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 physical score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0004
72485601|NCT02137512|144499005|SUPERIORITY|||||||0.02||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.02
72485602|NCT02137512|144499006|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
72485603|NCT02137512|144499006|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
72485604|NCT02137512|144499006|SUPERIORITY|||||||0.52||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.52
72485605|NCT02137512|144499007|SUPERIORITY|||||||0.13||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.13
72485606|NCT02137512|144499007|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
72485607|NCT02137512|144499007|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
72485608|NCT02137512|144499008|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
72485609|NCT02137512|144499008|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
72485610|NCT02137512|144499008|SUPERIORITY|||||||0.41||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.41
72485611|NCT02137512|144499009|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
72485612|NCT02137512|144499009|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
72485613|NCT02137512|144499009|SUPERIORITY|||||||0.12||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.12
72485614|NCT02137512|144499010|SUPERIORITY|||||||0.02||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.02
72485615|NCT02137512|144499010|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
72485616|NCT02137512|144499010|SUPERIORITY|||||||0.06||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.06
72485617|NCT02137512|144499011|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
72485618|NCT02137512|144499011|SUPERIORITY|||||||0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.001
72485619|NCT02137512|144499011|SUPERIORITY|||||||0.26||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.26
72485620|NCT02137512|144499012|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
72485621|NCT02137512|144499012|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
72512751|NCT00960934|144555979|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|39.66|||<|0.001|TWO_SIDED|95.0|22.44|57.17||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis|||||57.17|22.44|<.001
72512752|NCT00960934|144555979|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|20.68||||0.003|TWO_SIDED|95.0|5.72|35.78||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis|||||35.78|5.72|0.003
72512753|NCT00960934|144555979|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|8.59||||0.265|TWO_SIDED|95.0|-4.81|22.05||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis|||||22.05|-4.81|0.265
72402664|NCT01480076|144311689|SUPERIORITY_OR_OTHER||difference of LS means|-7.0|STANDARD_ERROR_OF_MEAN|3.58||0.0511|TWO_SIDED||||||mixed effect model|||Month 6, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 physical score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0511
72402665|NCT01480076|144311689|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 9, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 physical score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
72485622|NCT02137512|144499012|SUPERIORITY|||||||0.11||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.11
72485623|NCT02137512|144499013|SUPERIORITY|||||||0.02||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.02
72485624|NCT02137512|144499013|SUPERIORITY|||||||0.02||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.02
72485625|NCT02137512|144499013|SUPERIORITY|||||||0.61||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.61
72485626|NCT02137512|144499014|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
72485627|NCT02137512|144499014|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
72485628|NCT02137512|144499014|SUPERIORITY|||||||0.29||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.29
72567683|NCT00986180|144666907|NON_INFERIORITY_OR_EQUIVALENCE|The sample size was recalculated due to Amendment INT-1. The non-inferiority margin for SPID120 was set as 120. The common standard deviation for the SPID120 data was estimated to be 230. Seventy nine subjects in each arm would have 90% power to demonstrate the non-inferiority of NUCYNTA to oxycodone IR with a 1-sided significance level of 0.025. This would have required enrollment of total 158 mITT subjects for each stratum. The original sample size (292 mITT subjects) was derived for SPID72.|Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|16.02||0.9703|TWO_SIDED|95.0|-32.1|30.9|||ANCOVA|||||30.9|-32.1|0.9703
72567684|NCT00986180|144666908|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.8|STANDARD_ERROR_OF_MEAN|6.08||0.7691|TWO_SIDED|95.0|-10.1|13.7|||ANCOVA|||||13.7|-10.1|0.7691
72567685|NCT00986180|144666909|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.8|STANDARD_ERROR_OF_MEAN|9.24||0.9282|TWO_SIDED|95.0|-17.3|19.0|||ANCOVA|||||19.0|-17.3|0.9282
72567686|NCT00986180|144666910|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.6|STANDARD_ERROR_OF_MEAN|29.75||0.9562|TWO_SIDED|95.0|-60.1|56.8|||ANCOVA|||||56.8|-60.1|0.9562
72567687|NCT00986180|144666911|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.6|STANDARD_ERROR_OF_MEAN|6.08||0.7973|TWO_SIDED|95.0|-13.5|10.4|||ANCOVA|||||10.4|-13.5|0.7973
72567688|NCT00986180|144666912|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.5|STANDARD_ERROR_OF_MEAN|9.3||0.7882|TWO_SIDED|95.0|-20.8|15.8|||ANCOVA|||||15.8|-20.8|0.7882
72567689|NCT00986180|144666913|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.1|STANDARD_ERROR_OF_MEAN|15.82||0.7491|TWO_SIDED|95.0|-36.1|26.0|||ANCOVA|||||26.0|-36.1|0.7491
72567690|NCT00986180|144666914|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.6|STANDARD_ERROR_OF_MEAN|29.03||0.6897|TWO_SIDED|95.0|-68.6|45.4|||ANCOVA|||||45.4|-68.6|0.6897
72567691|NCT00986180|144666915|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.6|STANDARD_ERROR_OF_MEAN|7.02||0.8226|TWO_SIDED|95.0|-12.2|15.4|||ANCOVA|||||15.4|-12.2|0.8226
72567692|NCT00986180|144666916|SUPERIORITY_OR_OTHER|||||||0.888|||||||Wilcoxon (Mann-Whitney)|||||||0.8880
72567693|NCT00986180|144666917|SUPERIORITY_OR_OTHER|||||||0.4115|||||||Wilcoxon (Mann-Whitney)|||||||0.4115
72567694|NCT00986180|144666918|SUPERIORITY_OR_OTHER|||||||0.8495|||||||Wilcoxon (Mann-Whitney)|||||||0.8495
72485629|NCT02137512|144499015|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
72567695|NCT00986180|144666919|SUPERIORITY_OR_OTHER|||||||0.7846|||||||Wilcoxon (Mann-Whitney)|||||||0.7846
72567696|NCT00986180|144666920|SUPERIORITY_OR_OTHER|||||||0.479|||||||Wilcoxon (Mann-Whitney)|||||||0.4790
72567697|NCT00986180|144666921|SUPERIORITY_OR_OTHER|||||||0.3147|||||||Wilcoxon (Mann-Whitney)|||||||0.3147
72567698|NCT00986180|144666922|SUPERIORITY_OR_OTHER|||||||0.5411|||||||Wilcoxon (Mann-Whitney)|||||||0.5411
72567699|NCT00986180|144666923|SUPERIORITY_OR_OTHER|||||||0.6137|||||||Wilcoxon (Mann-Whitney)|||||||0.6137
72567700|NCT00986180|144666924|SUPERIORITY_OR_OTHER|||||||0.7246|||||||Wilcoxon (Mann-Whitney)|||||||0.7246
72567701|NCT00986180|144666925|SUPERIORITY_OR_OTHER|||||||0.4882|||||||Wilcoxon (Mann-Whitney)|||||||0.4882
72485630|NCT02137512|144499015|SUPERIORITY|||||||0.005||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.005
72485631|NCT02137512|144499015|SUPERIORITY||||||>|0.99||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||>0.99
72485632|NCT02137512|144499016|SUPERIORITY|||||||0.006||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.006
72485633|NCT02137512|144499016|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
72485634|NCT02137512|144499016|SUPERIORITY|||||||0.09||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.09
72485635|NCT02137512|144499017|SUPERIORITY|||||||0.002||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.002
72485636|NCT02137512|144499017|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
72567702|NCT00986180|144666926|SUPERIORITY_OR_OTHER|||||||0.7201|||||||Cochran-Mantel-Haenszel|||||||0.7201
72567703|NCT00986180|144666928|SUPERIORITY_OR_OTHER|||||||0.5208|||||||Cochran-Mantel-Haenszel|||||||0.5208
72567704|NCT00986180|144666930|SUPERIORITY_OR_OTHER|||||||0.0401|||||||Cochran-Mantel-Haenszel|||||||0.0401
72485637|NCT02137512|144499017|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
72485638|NCT02137512|144499018|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
72485639|NCT02137512|144499018|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
72402666|NCT01480076|144311689|SUPERIORITY_OR_OTHER|||||||0.8703|||||||mixed effect model|||Month 9, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 physical score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.8703
72402667|NCT01480076|144311689|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 9, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 physical score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
72512754|NCT00960934|144555979|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|8.39||||0.265|TWO_SIDED|95.0|-3.4|20.21||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis|||||20.21|-3.40|0.265
72485640|NCT02137512|144499018|SUPERIORITY|||||||0.26||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.26
72485641|NCT02137512|144499019|SUPERIORITY|||||||0.04||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.04
72485642|NCT02137512|144499019|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
72485643|NCT02137512|144499019|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
72485644|NCT02137512|144499020|SUPERIORITY|||||||0.006||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.006
72485645|NCT02137512|144499020|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
72485646|NCT02137512|144499020|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
72485647|NCT02137512|144499021|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 1 sided|||||||<0.001
72485648|NCT02137512|144499021|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
72485649|NCT02137512|144499021|SUPERIORITY|||||||0.53||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.53
72485650|NCT02137512|144499022|SUPERIORITY|||||||0.05||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.05
72485651|NCT02137512|144499022|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
72485652|NCT02137512|144499022|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
72485653|NCT02137512|144499023|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
72485654|NCT02137512|144499023|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
72485655|NCT02137512|144499023|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
72485656|NCT02137512|144499024|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
72485657|NCT02137512|144499024|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
72485658|NCT02137512|144499024|SUPERIORITY|||||||0.22||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.22
72485659|NCT02137512|144499025|SUPERIORITY|||||||0.03||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.03
72485660|NCT02137512|144499025|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
72485661|NCT02137512|144499025|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
72485662|NCT02137512|144499026|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
72485663|NCT02137512|144499026|SUPERIORITY|||||||0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.001
72485664|NCT02137512|144499026|SUPERIORITY|||||||0.26||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.26
72485665|NCT02137512|144499027|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
72485666|NCT02137512|144499027|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
72485667|NCT02137512|144499027|SUPERIORITY|||||||0.05||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.05
72485668|NCT02137512|144499028|SUPERIORITY|||||||0.03||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.03
72485669|NCT02137512|144499028|SUPERIORITY|||||||0.02||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.02
72485670|NCT02137512|144499028|SUPERIORITY|||||||0.52||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.52
72485671|NCT02137512|144499029|SUPERIORITY|||||||0.003||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.003
72485672|NCT02137512|144499029|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
72485673|NCT02137512|144499029|SUPERIORITY|||||||0.71||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.71
72485674|NCT02137512|144499030|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
72485675|NCT02137512|144499030|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
72485676|NCT02137512|144499030|SUPERIORITY|||||||0.39||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.39
72485677|NCT02137512|144499031|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
72485678|NCT02137512|144499031|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
72485679|NCT02137512|144499031|SUPERIORITY|||||||0.06||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.06
72485680|NCT02137512|144499032|SUPERIORITY|||||||0.02||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.02
72512755|NCT00960934|144555980|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|53.05|||<|0.001|TWO_SIDED|95.0|37.83|68.53||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||68.53|37.83|<0.001
72512756|NCT00960934|144555980|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|41.41|||<|0.001|TWO_SIDED|95.0|27.36|55.65||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||55.65|27.36|<0.001
72512757|NCT00960934|144555980|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|24.81|||<|0.001|TWO_SIDED|95.0|12.39|37.33||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||37.33|12.39|<0.001
72512758|NCT00960934|144555980|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|12.87||||0.02|TWO_SIDED|95.0|1.73|24.06||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||24.06|1.73|0.020
72512759|NCT00960934|144555980|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|4.02||||0.397|TWO_SIDED|95.0|-5.31|13.36||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||13.36|-5.31|0.397
72512760|NCT02387372|144555993|OTHER||Geometric least squares mean ratio (GMR)|1.38|||||TWO_SIDED|90.0|1.21|1.56|||||Ratio of Last Dose/First Dose|Accumulation Ratio of Last Dose/First Dose||1.56|1.21|
72512761|NCT02387372|144555993|OTHER||GMR|1.15|||||TWO_SIDED|90.0|1.03|1.29|||||Ratio of Last Dose/First Dose|Accumulation Ratio of Last Dose/First Dose||1.29|1.03|
72512762|NCT02387372|144555996|OTHER||Geometric least squares mean ratio (GMR)|1.71|||||TWO_SIDED|90.0|1.5|1.96|||||Ratio of Last Dose/First Dose|Accumulation Ratio of Last Dose/First Dose||1.96|1.50|
72512763|NCT02387372|144555996|OTHER||GMR|1.33|||||TWO_SIDED|90.0|1.14|1.55|||||Ratio of Last Dose/First Dose|Accumulation Ratio of Last Dose/First Dose||1.55|1.14|
72512764|NCT02387372|144555998|OTHER||Geometric least squares mean ratio (GMR)|1.61|||||TWO_SIDED|90.0|1.44|1.81|||||Ratio of Last Dose/First Dose|Accumulation Ratio of Last Dose/First Dose||1.81|1.44|
72512765|NCT02387372|144555998|OTHER||GMR|1.24|||||TWO_SIDED|90.0|1.11|1.39|||||Ratio of Last Dose/First Dose|Accumulation Ratio of Last Dose/First Dose||1.39|1.11|
72512766|NCT02387372|144555999|OTHER||Geometric least squares mean ratio (GMR)|1.71|||||TWO_SIDED|90.0|1.51|1.95|||||Ratio of Last Dose/First Dose|Accumulation Ratio of Last Dose/First Dose||1.95|1.51|
72512767|NCT02387372|144555999|OTHER||GMR|1.2|||||TWO_SIDED|90.0|1.09|1.33|||||Ratio of Last Dose/First Dose|Accumulation Ratio of Last Dose/First Dose||1.33|1.09|
72512768|NCT02190747|144556065|OTHER|||||||0.1664|||||||Cochran-Armitage test of trend|||Cochran-Armitage test of trend (one-sided). The Cochran-Armitage test of trend assessed the overall trend of response across the dose groups (from the lowest dose \[or placebo\], to the highest dose).||||0.1664
72512769|NCT02190747|144556066|OTHER|||||||0.2335|||||||Cochran-Armitage test of trend|||Week 6: Cochran-Armitage test of trend (one-sided). The Cochran-Armitage test of trend assessed the overall trend of response across the dose groups (from the lowest dose \[or placebo\], to the highest dose).||||0.2335
72512770|NCT02190747|144556066|OTHER|||||||0.0837|||||||Cochran-Armitage test of trend|||Week 12: Cochran-Armitage test of trend (one-sided). The Cochran-Armitage test of trend assessed the overall trend of response across the dose groups (from the lowest dose \[or placebo\], to the highest dose).||||0.0837
72512771|NCT02190747|144556067|OTHER||Least square (LS) mean|-86.35|STANDARD_ERROR_OF_MEAN|220.57||0.6984|TWO_SIDED||||||Pairwise test|||Week 6: Analysis of area of new HO||||0.6984
72512772|NCT02190747|144556067|OTHER||LS mean|-38.07|STANDARD_ERROR_OF_MEAN|252.192||0.8811|TWO_SIDED||||||Pairwise test|||Week 6: Analysis of area of new HO||||0.8811
72512773|NCT02190747|144556067|OTHER||LS mean|-764.38|STANDARD_ERROR_OF_MEAN|220.57||0.0017|TWO_SIDED||||||Pairwise test|||Week 12: Analysis of area of new HO||||0.0017
72512774|NCT02190747|144556067|OTHER||LS mean|-703.43|STANDARD_ERROR_OF_MEAN|252.192||0.0094|TWO_SIDED||||||Pairwise test|||Week 12: Analysis of area of new HO||||0.0094
72512775|NCT02190747|144556068|OTHER|||||||0.1503|||||||Cochran-Armitage test of trend|||Cochran-Armitage test of trend (one-sided). The Cochran-Armitage test of trend assessed the overall trend of response across the dose groups (from the lowest dose \[or placebo\], to the highest dose).||||0.1503
72512776|NCT03709810|144556095|SUPERIORITY||Geometric Mean Ratio|0.19|||<|0.0001|TWO_SIDED|95.0|0.12|0.3|||ANOVA|Log10 peanuts mass as response variable, study product and period as fixed explanatory effects, and participant as a random effect.|GMR=(Experimental denture adhesive/ No Adhesive)|||0.30|0.12|<0.0001
72512777|NCT04866303|144556106|OTHER|unadjusted logistic regression model|Odds Ratio (OR)|1.79||||0.04|TWO_SIDED|95.0|1.03|2.8|||Regression, Logistic|||Minimum testing kit completion rate of 70% in the passive study arm, and calculated that 400 total subjects would provide us with 90% power to detect an effect size associated with a rate ratio of 1.20, or an absolute difference of 14% (70% in passive, 84% in active). A futility boundary of 60% was identified by Community Advisory Board members as justification to prematurely halt trial enrollment if, after completing 25% of expected enrollment, successful test completion fell below that rate.||2.80|1.03|0.04
72512778|NCT04866303|144556107|OTHER||Odds Ratio (OR)|1.39||||0.18|TWO_SIDED|95.0|0.86|2.26|||Regression, Logistic|||Minimum testing kit completion rate of 70% in the passive study arm, and calculated that 400 total subjects would provide us with 90% power to detect an effect size associated with a rate ratio of 1.20, or an absolute difference of 14% (70% in passive, 84% in active). A futility boundary of 60% was identified by Community Advisory Board members as justification to prematurely halt trial enrollment if, after completing 25% of expected enrollment, successful test completion fell below that rate||2.26|0.86|0.18
72512779|NCT02665364|144556135|SUPERIORITY||arithmetic mean|-30.2802|STANDARD_ERROR_OF_MEAN|5.2588|<|0.0001|TWO_SIDED|95.0|-40.6653|-19.8951|||ANCOVA|||The percent of change from baseline to last available value between W24 and W36 of treatment in the expression of IFN-induced genes was analyzed using an analysis of covariance (ANCOVA) model.||-19.8951|-40.6653|< 0.0001
72567705|NCT00986180|144666932|SUPERIORITY_OR_OTHER|||||||0.4679|||||||Cochran-Mantel-Haenszel|||||||0.4679
72567706|NCT00986180|144666934|SUPERIORITY_OR_OTHER|||||||0.1454|||||||Fisher Exact|||||||0.1454
72512780|NCT02665364|144556136|SUPERIORITY||Odds Ratio (OR)|1.38||||0.34|TWO_SIDED|95.0|0.716|2.657|||Regression, Logistic|||Descriptive statistics for the response to treatment according to BICLA at week 36 were presented by treatment group. The response to treatment according to BICLA was analyzed using a logistic regression with the response rate as dependent variable and treatment as independent variable, while adjusting for the minimization factors used for randomization.||2.657|0.716|0.34
72512781|NCT02665364|144556137|SUPERIORITY||Odds Ratio (OR)|1.18||||0.6243|TWO_SIDED|95.0|0.602|2.329|||Regression, Logistic|||The SRI-4 response was analyzed using a logistic regression using the response rate as dependent variable and treatment as independent variable, while adjusting for the minimization factors used for randomization.||2.329|0.602|0.6243
72512782|NCT02665364|144556138|SUPERIORITY|||||||0.0022|||||||Pearson's Chi-squared|||||||0.0022
72512783|NCT02665364|144556139|SUPERIORITY|||||||0.7946|||||||Wilcoxon (Mann-Whitney)|||Baseline to last available value between W24 and W36||||0.7946
72512784|NCT02665364|144556140|SUPERIORITY|||||||0.9224|||||||student - pooled|||||||0.9224
72512785|NCT02665364|144556141|SUPERIORITY|||||||0.3258|||||||student - pooled|||||||0.3258
72512786|NCT02665364|144556142|SUPERIORITY|||||||0.6169|||||||Student - Satterthwaite|||||||0.6169
72512787|NCT02665364|144556143|SUPERIORITY||Odds Ratio (OR)|1.81||||0.0796|TWO_SIDED|95.0|0.932|3.524|||Regression, Logistic|||||3.524|0.932|0.0796
72512788|NCT02665364|144556144|SUPERIORITY||Odds Ratio (OR)|1.83||||0.0762|TWO_SIDED|95.0|0.938|3.574|||Regression, Logistic|||||3.574|0.938|0.0762
72512789|NCT02665364|144556147|SUPERIORITY|||||||0.0097|||||||Student - Satterthwaite|||||||0.0097
72512790|NCT02665364|144556148|SUPERIORITY|||||||0.0425|||||||Pearson's Chi-squared|||||||0.0425
72512791|NCT02665364|144556149|SUPERIORITY|||||||0.0396|||||||Pearson's Chi-squared|||||||0.0396
72512792|NCT03888391|144556150|SUPERIORITY|||||||0.2|||||||Mixed Models Analysis|Time: F = 1.72, df = 1/34||Outcomes fitted via a mixed model with time as a predictor.||||.20
72512793|NCT03888391|144556152|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|Time: F = 44.47, df = 1/33||Outcomes fitted via a mixed model with time as a predictor.||||<.0001
72512794|NCT03888391|144556153|SUPERIORITY|||||||0.0004|||||||Mixed Models Analysis|Time: F = 15.74, df = 1/34||Outcomes fitted via a mixed model with time as a predictor.||||.0004
72512795|NCT03888391|144556154|SUPERIORITY|||||||0.6|||||||Mixed Models Analysis|Time: F = .28, df = 1/34||Outcomes fitted via a mixed model with time as a predictor.||||.60
72512796|NCT03888391|144556155|SUPERIORITY|||||||0.32|||||||Mixed Models Analysis|Time: F = 1.04, df = 1/34||Outcomes fitted via a mixed model with time as a predictor.||||.32
72512797|NCT03888391|144556156|SUPERIORITY|||||||0.27|||||||Mixed Models Analysis|Time: F = 1.27, df = 1/34||Outcomes fitted via a mixed model with time as a predictor.||||.27
72512798|NCT01954251|144556169|NON_INFERIORITY_OR_EQUIVALENCE|Comparison at one month after the last dose of HZ/su was performed between the Control group and GSK1437173A + GSK2321138A group. The GSK1437173A + GSK2321138A group was considered as statistically significant non-inferior compared to the Control group in terms of immunogenicity if the UL of the 2-sided 95% CI of the ratio of GMs between the Control and the Co-Ad group (Control over GSK1437173A + GSK2321138A) was below 1.5.|Adjusted Geometric mean concentration ra|1.08|||||TWO_SIDED|95.0|0.97|1.2||||||Adjusted ratios of Control group over GSK1437173A + GSK2321138A group in anti-gE antibody ELISA concentrations GMCs at one month after last vaccine dose. An Analysis of Covariance (ANCOVA) model was used to analyse post-vaccination log-transformed concentrations of anti-gE. The fixed-effect model included the minimisation variable (age cohorts) and the treatment as fixed effect. The pre-vaccination log-transformed concentrations were included as continuous covariate.||1.20|0.97|
72512799|NCT01954251|144556170|NON_INFERIORITY_OR_EQUIVALENCE|Comparisons at Day 21 after the FLU-D-QIV dose were performed between the Control group and GSK1437173A + GSK2321138A group. The GSK1437173A + GSK2321138A group was considered as statistically significant non inferior compared to the Control group in terms of immunogenicity (for each strain) if the UL of 2-sided 95% CI of the ratio of GMTs between the Control and the GSK1437173A + GSK2321138A (Control/ GSK1437173A + GSK2321138A) group is below 1.5.|Adjusted geometric mean Titer ratio|1.04|||||TWO_SIDED|95.0|0.88|1.22||||||For the Flu A/California/7/2009 H1N1 strain ,an ANOVA model was used to analyze post-vaccination log-transformed titers. The fixed-effect model included the minimization variable (age cohorts) and the treatment as fixed effect. The pre-vaccination log-transformed concentrations were included as continuous covariate. GMs of post-vaccination titers (Day 21) were calculated conditionally to the means of the pre-vaccination log-transformed titers (Month 0) for this strain.||1.22|0.88|
72512800|NCT01954251|144556170|NON_INFERIORITY_OR_EQUIVALENCE|Comparisons at Day 21 after the FLU-D-QIV dose were performed between the Control group and GSK1437173A + GSK2321138A group. The GSK1437173A + GSK2321138A group was considered as statistically significant non inferior compared to the Control group in terms of immunogenicity (for each strain) if the UL of 2-sided 95% CI of the ratio of GMTs between the Control and the GSK1437173A + GSK2321138A (Control/ GSK1437173A + GSK2321138A) group is below 1.5.|Adjusted geometric mean Titer ratio|1.03|||||TWO_SIDED|95.0|0.91|1.17||||||For the Flu A/Texas/50/2012 H3N2 strain ,an ANOVA model was used to analyze post-vaccination log-transformed titers. The fixed-effect model included the minimization variable (age cohorts) and the treatment as fixed effect. The pre-vaccination log-transformed concentrations were included as continuous covariate. GMs of post-vaccination titers (Day 21) were calculated conditionally to the means of the pre-vaccination log-transformed titers (Month 0) for this strain.||1.17|0.91|
72512801|NCT01954251|144556170|NON_INFERIORITY_OR_EQUIVALENCE|Comparisons at Day 21 after the FLU-D-QIV dose were performed between the Control group and GSK1437173A + GSK2321138A group. The GSK1437173A + GSK2321138A group was considered as statistically significant non inferior compared to the Control group in terms of immunogenicity (for each strain) if the UL of 2-sided 95% CI of the ratio of GMTs between the Control and the GSK1437173A + GSK2321138A (Control/ GSK1437173A + GSK2321138A) group is below 1.5.|Adjusted geometric mean Titer ratio|1.07|||||TWO_SIDED|95.0|0.95|1.2||||||For the Flu B/Brisbane/60/2008 Victoria strain ,an ANOVA model was used to analyze post-vaccination log-transformed titers. The fixed-effect model included the minimization variable (age cohorts) and the treatment as fixed effect. The pre-vaccination log-transformed concentrations were included as continuous covariate. GMs of post-vaccination titers (Day 21) were calculated conditionally to the means of the pre-vaccination log-transformed titers (Month 0) for this strain.||1.20|0.95|
72567707|NCT00986180|144666935|SUPERIORITY_OR_OTHER|||||||0.1541|||||||Fisher Exact|||||||0.1541
72567708|NCT00986180|144666937|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.38|||||TWO_SIDED|95.0|0.92|2.06|||Cochran-Mantel-Haenszel|||||2.06|0.92|
72485681|NCT02137512|144499032|SUPERIORITY|||||||0.003||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.003
72512802|NCT01954251|144556170|NON_INFERIORITY_OR_EQUIVALENCE|Comparisons at Day 21 after the FLU-D-QIV dose were performed between the Control group and GSK1437173A + GSK2321138A group. The GSK1437173A + GSK2321138A group was considered as statistically significant non inferior compared to the Control group in terms of immunogenicity (for each strain) if the UL of 2-sided 95% CI of the ratio of GMTs between the Control and the GSK1437173A + GSK2321138A (Control/ GSK1437173A + GSK2321138A) group is below 1.5.|Adjusted geometric mean Titer ratio|0.98|||||TWO_SIDED|95.0|0.88|1.09||||||For the Flu B/Massachusetts/2/2012 Yamagata strain ,an ANOVA model was used to analyze post-vaccination log-transformed titers. The fixed-effect model included the minimization variable (age cohorts) and the treatment as fixed effect. The pre-vaccination log-transformed concentrations were included as continuous covariate. GMs of post-vaccination titers (Day 21) were calculated conditionally to the means of the pre-vaccination log-transformed titers (Month 0) for this strain.||1.09|0.88|
72512803|NCT02175771|144556188|SUPERIORITY||geometric mean ratio|1.32|||||TWO_SIDED|90.0|1.02|1.72|||||Fp MDPI / FLOVENT HFA|Mid-strength comparison||1.72|1.02|
72512804|NCT02175771|144556188|SUPERIORITY||geometric mean ratio|0.81|||||TWO_SIDED|90.0|0.63|1.04|||||Fp MDPI / FLOVENT HFA|High-strength comparison||1.04|0.63|
72402668|NCT01480076|144311689|SUPERIORITY_OR_OTHER|||||||0.9049|||||||mixed effect model|||Month 9, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 physical score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.9049
72485682|NCT02137512|144499032|SUPERIORITY|||||||0.86||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.86
72485683|NCT02137512|144499033|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
72512805|NCT02175771|144556188|SUPERIORITY||geometric mean ratio|0.96|||||TWO_SIDED|90.0|0.75|1.24|||||FS MDPI / ADVAIR DISKUS|Mid-strength comparison||1.24|0.75|
72512806|NCT02175771|144556188|SUPERIORITY||geometric mean ratio|0.84|||||TWO_SIDED|90.0|0.67|1.06|||||FS MDPI / ADVAIR DISKUS|High-strength comparison||1.06|0.67|
72512807|NCT02175771|144556189|NON_INFERIORITY|The study had reasonable power for demonstrating non-inferiority of the study drug to the comparator drug within each cohort. The statistical analysis plan specified that non-inferiority would be demonstrated if the lower limit of the 2-sided 95% confidence interval (CI) for the treatment difference was greater than -125 mL.|LSM difference|0.009|STANDARD_ERROR_OF_MEAN|0.0476||0.8451|TWO_SIDED|95.0|-0.084|0.103|||mixed model for repeated measures||Fp MDPI / FLOVENT HFA|Mid-strength comparison||0.103|-0.084|0.8451
72512808|NCT02175771|144556189|NON_INFERIORITY|The study had reasonable power for demonstrating non-inferiority of the study drug to the comparator drug within each cohort. The statistical analysis plan specified that non-inferiority would be demonstrated if the lower limit of the 2-sided 95% confidence interval (CI) for the treatment difference was greater than -125 mL.|LSM difference|-0.013|STANDARD_ERROR_OF_MEAN|0.0479||0.7877|TWO_SIDED|95.0|-0.107|0.081|||mixed model for repeated measures||Fp MDPI / FLOVENT HFA|High-strength comparison||0.081|-0.107|0.7877
72512809|NCT02175771|144556189|NON_INFERIORITY|The study had reasonable power for demonstrating non-inferiority of the study drug to the comparator drug within each cohort. The statistical analysis plan specified that non-inferiority would be demonstrated if the lower limit of the 2-sided 95% confidence interval (CI) for the treatment difference was greater than -125 mL.|LSM difference|0.0|STANDARD_ERROR_OF_MEAN|0.0485||0.9966|TWO_SIDED|95.0|-0.095|0.095|||mixed model for repeated measures||FS MDPI / ADVAIR DISKUS|Mid-strength comparison||0.095|-0.095|0.9966
72512810|NCT02175771|144556189|NON_INFERIORITY|The study had reasonable power for demonstrating non-inferiority of the study drug to the comparator drug within each cohort. The statistical analysis plan specified that non-inferiority would be demonstrated if the lower limit of the 2-sided 95% confidence interval (CI) for the treatment difference was greater than -125 mL.|LSM difference|0.059|STANDARD_ERROR_OF_MEAN|0.0464||0.2056|TWO_SIDED|95.0|-0.032|0.15|||mixed model for repeated measures||FS MDPI / ADVAIR DISKUS|High-strength comparison||0.150|-0.032|0.2056
72512811|NCT02232087|144556190|EQUIVALENCE|The potency of the test and reference product was considered equivalent if the 90% CI for the estimate of relative potency was completely contained within the limits of 0.67 to 1.50|Odds Ratio, log|1.0|||>|0.1|TWO_SIDED|90.0|0.67|1.5||test for parallelism of dose response lines|ANOVA||Test is the numerator|The measurement of relative potency was conducted for the pair of doses which met the above criteria and lay on the steepest linear portion of the dose response curve. The log estimate of relative potency was obtained as the ratio of the estimated treatment effect as measured by the difference in the intercepts of the parallel lines divided by the estimate of the common slope for log dose.||1.50|0.67|>0.10
72485684|NCT02137512|144499033|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
72512812|NCT02232087|144556191|EQUIVALENCE|The potency of the test and reference product was considered equivalent if the 90% CI for the estimate of relative potency was completely contained within the limits of 0.67 to 1.50|Odds Ratio, log|1.0|||>|0.1|TWO_SIDED|90.0|0.67|1.5||test for parallelism of dose response lines|ANOVA||Test is the numerator|The measurement of relative potency was conducted for the pair of doses which met the above criteria and lay on the steepest linear portion of the dose response curve. The log estimate of relative potency was obtained as the ratio of the estimated treatment effect as measured by the difference in the intercepts of the parallel lines divided by the estimate of the common slope for log dose.||1.50|0.67|>0.10
72512813|NCT02232087|144556192|EQUIVALENCE|Comparability confirmed if confidence interval includes zero.|Mean Difference (Final Values)|0.0||||0.55|TWO_SIDED|95.0|-2.5|1.4||Comparability demonstrated for p\>0.05|ANOVA||Comparability confirmed if confidence interval includes zero.|For each dose, the 95% CIs for the mean differences for the test product versus the reference product were calculated.||1.4|-2.5|0.55
72567709|NCT00986180|144666938|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.74|||||TWO_SIDED|95.0|1.17|2.57|||Cochran-Mantel-Haenszel|||||2.57|1.17|
72567710|NCT00986180|144666939|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.43|||||TWO_SIDED|95.0|1.45|8.11|||Cochran-Mantel-Haenszel|||||8.11|1.45|
72485685|NCT02137512|144499033|SUPERIORITY|||||||0.74||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.74
72485686|NCT02137512|144499034|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
72402669|NCT01480076|144311689|SUPERIORITY_OR_OTHER||difference of LS means|-7.6|STANDARD_ERROR_OF_MEAN|2.44||0.0019|TWO_SIDED||||||mixed effect model|||Month 9, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 physical score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0019
72402670|NCT01480076|144311689|SUPERIORITY_OR_OTHER||difference of LS means|-12.3|STANDARD_ERROR_OF_MEAN|4.15||0.0033|TWO_SIDED||||||mixed effect model|||Month 9, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 physical score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0033
72402671|NCT01480076|144311689|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 12, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 physical score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
72402672|NCT01480076|144311689|SUPERIORITY_OR_OTHER|||||||0.4087|||||||mixed effect model|||Month 12, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 physical score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.4087
72402673|NCT01480076|144311689|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 12, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 physical score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
72402674|NCT01480076|144311689|SUPERIORITY_OR_OTHER|||||||0.2755|||||||mixed effect model|||Month 12, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 physical score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.2755
72402675|NCT01480076|144311689|SUPERIORITY_OR_OTHER||difference of LS means|-5.7|STANDARD_ERROR_OF_MEAN|2.52||0.0251|TWO_SIDED||||||mixed effect model|||Month 12, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 physical score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0251
72402676|NCT01480076|144311689|SUPERIORITY_OR_OTHER||difference of LS means|-6.7|STANDARD_ERROR_OF_MEAN|4.08||0.0989|TWO_SIDED||||||mixed effect model|||Month 12, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 physical score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0989
72402677|NCT01480076|144311690|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Overall, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 psychological score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
72402678|NCT01480076|144311690|SUPERIORITY_OR_OTHER|||||||0.8767|||||||mixed effect model|||Overall, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 psychological score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.8767
72402679|NCT01480076|144311690|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Overall, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 psychological score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
72485687|NCT02137512|144499034|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
72485688|NCT02137512|144499034|SUPERIORITY|||||||0.09||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.09
72485689|NCT02137512|144499035|SUPERIORITY|||||||0.07||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.07
72485690|NCT02137512|144499035|SUPERIORITY|||||||0.006||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.006
72485691|NCT02137512|144499035|SUPERIORITY|||||||0.68||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.68
72485692|NCT02137512|144499036|SUPERIORITY|||||||0.006||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.006
72485693|NCT02137512|144499036|SUPERIORITY|||||||0.005||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.005
72485694|NCT02137512|144499036|SUPERIORITY|||||||0.62||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.62
72485695|NCT02137512|144499037|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
72485696|NCT02137512|144499037|SUPERIORITY|||||||0.006||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.006
72485697|NCT02137512|144499037|SUPERIORITY|||||||0.23||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.23
72512814|NCT02232087|144556192|EQUIVALENCE|Comparability confirmed if confidence interval includes zero.|Mean Difference (Final Values)|1.0||||0.53|TWO_SIDED|95.0|-2.5|1.3||Comparability demonstrated for p\>0.05|ANOVA||Comparability confirmed if confidence interval includes zero.|For each dose, the 95% CIs for the mean differences for the test product versus the reference product were calculated.||1.3|-2.5|0.53
72485698|NCT02137512|144499038|SUPERIORITY|||||||0.67||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.67
72512815|NCT02232087|144556192|EQUIVALENCE|Comparability confirmed if confidence interval includes zero.|Mean Difference (Final Values)|1.0||||0.011|TWO_SIDED|95.0|-2.5|1.3||Comparability demonstrated for p\>0.05|ANOVA||Comparability confirmed if confidence interval includes zero.|For each dose, the 95% CIs for the mean differences for the test product versus the reference product were calculated.||1.3|-2.5|0.011
72512816|NCT02232087|144556193|EQUIVALENCE|Comparability confirmed if confidence interval includes zero.|Mean Difference (Final Values)|0.0||||0.26|TWO_SIDED|95.0|-0.03|0.1||Comparability demonstrated for p\>0.05|ANOVA||Comparability confirmed if confidence interval includes zero.|For each dose, the 95% CIs for the mean differences for the test product versus the reference product were calculated.||0.10|-0.03|0.26
72512817|NCT02232087|144556193|EQUIVALENCE|Comparability confirmed if confidence interval includes zero.|Mean Difference (Final Values)|0.0||||0.93|TWO_SIDED|95.0|-0.06|0.06||Comparability demonstrated for p\>0.05|ANOVA||Comparability confirmed if confidence interval includes zero.|For each dose, the 95% CIs for the mean differences for the test product versus the reference product were calculated.||0.06|-0.06|0.93
72485699|NCT02137512|144499038|SUPERIORITY|||||||0.09||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.09
72512818|NCT02232087|144556193|EQUIVALENCE|Comparability confirmed if confidence interval includes zero.|Mean Difference (Final Values)|0.0||||0.48|TWO_SIDED|95.0|-0.04|0.08||Comparability demonstrated for p\>0.05|ANOVA||Comparability confirmed if confidence interval includes zero.|For each dose, the 95% CIs for the mean differences for the test product versus the reference product were calculated.||0.08|-0.04|0.48
72512819|NCT02232087|144556194|EQUIVALENCE|Comparability confirmed if confidence interval includes zero.|Mean Difference (Final Values)|0.0||||0.93|TWO_SIDED|95.0||||Comparability demonstrated for p\>0.05|ANOVA||Comparability confirmed if confidence interval includes zero.|For each dose, the 95% CIs for the mean differences for the test product versus the reference product were calculated.||||0.93
72512820|NCT02232087|144556194|EQUIVALENCE|Comparability confirmed if confidence interval includes zero.|Mean Difference (Final Values)|0.0||||0.42|TWO_SIDED|95.0|-0.224|0.093||Comparability demonstrated for p\>0.05|ANOVA||Comparability confirmed if confidence interval includes zero.|For each dose, the 95% CIs for the mean differences for the test product versus the reference product were calculated.||0.093|-0.224|0.42
72512821|NCT02232087|144556194|EQUIVALENCE|Comparability confirmed if confidence interval includes zero.|Mean Difference (Final Values)|0.0||||0.078|TWO_SIDED|95.0|-0.302|0.016||Comparability demonstrated for p\>0.05|ANOVA||Comparability confirmed if confidence interval includes zero.|For each dose, the 95% CIs for the mean differences for the test product versus the reference product were calculated.||0.016|-0.302|0.078
72512822|NCT02232087|144556195|EQUIVALENCE|Comparability confirmed if confidence interval includes zero.|Mean Difference (Final Values)|0.0||||0.71|TWO_SIDED|95.0|-3.9|5.7||Comparability demonstrated for p\>0.05|ANOVA||Comparability confirmed if confidence interval includes zero.|For each dose, the 95% CIs for the mean differences for the test product versus the reference product were calculated.||5.7|-3.9|0.71
72512823|NCT02232087|144556195|EQUIVALENCE|Comparability confirmed if confidence interval includes zero.|Mean Difference (Final Values)|0.0||||1|TWO_SIDED|95.0|-4.7|4.7||Comparability demonstrated for p\>0.05|ANOVA||Comparability confirmed if confidence interval includes zero.|For each dose, the 95% CIs for the mean differences for the test product versus the reference product were calculated.||4.7|-4.7|1.00
72512824|NCT02232087|144556195|EQUIVALENCE|Comparability confirmed if confidence interval includes zero.|Mean Difference (Final Values)|-2.0||||0.016|TWO_SIDED|95.0|-10.6|-1.1||Comparability demonstrated for p\>0.05|ANOVA||Comparability confirmed if confidence interval includes zero.|For each dose, the 95% CIs for the mean differences for the test product versus the reference product were calculated.||-1.1|-10.6|0.016
72512825|NCT04069156|144556196|NON_INFERIORITY|The primary end point assessing non-inferiority of placebo was considered met if the lower boundary of the one-sided 97.5% confidence limit of the difference in the composite success rate between treatment arms (placebo minus aspirin) was greater than the non-inferiority margin (-10%) by the Farrington-Manning test at 12-months in the principal analysis population.|Risk Difference (RD)|6.0|||<|0.0001|ONE_SIDED|97.5|-1.6||||Farrington-Manning risk difference||||||-1.6|<0.0001
72512826|NCT01098461|144556233|NON_INFERIORITY_OR_EQUIVALENCE|The p-value is from a two-sided t-test for the difference in means. Dunnett's method is used to adjust for multiple comparisons.|Mean Difference (Final Values)|-0.89|||<|0.0001|TWO_SIDED|95.0|-1.22|-0.57|||t-test, 2 sided|||||-0.57|-1.22|<0.0001
72512827|NCT01098461|144556233|NON_INFERIORITY_OR_EQUIVALENCE|The p-value is from a two-sided t-test for the difference in means. Dunnett's method is used to adjust for multiple comparisons.|Mean Difference (Final Values)|-1.55|||<|0.0001|TWO_SIDED|95.0|-1.88|-1.23|||t-test, 2 sided|||||-1.23|-1.88|<0.0001
72485700|NCT02137512|144499038|SUPERIORITY|||||||0.22||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.22
72485701|NCT02137512|144499039|SUPERIORITY|||||||0.25||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.25
72485702|NCT02137512|144499040|SUPERIORITY|||||||0.23||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.23
72485703|NCT02137512|144499041|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
72485704|NCT02137512|144499042|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
72485705|NCT02137512|144499043|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
72485706|NCT02137512|144499044|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
72485707|NCT02137512|144499045|SUPERIORITY|||||||0.01||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.01
72485708|NCT02137512|144499046|SUPERIORITY|||||||0.006||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.006
72485709|NCT02137512|144499047|SUPERIORITY|||||||0.14||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.14
72402680|NCT01480076|144311690|SUPERIORITY_OR_OTHER|||||||0.3673|||||||mixed effect model|||Overall, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 psychological score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.3673
72402681|NCT01480076|144311690|SUPERIORITY_OR_OTHER||difference of LS means|-6.8|STANDARD_ERROR_OF_MEAN|1.91||0.0004|TWO_SIDED||||||mixed effect model|||Overall, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 psychological score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0004
72402682|NCT01480076|144311690|SUPERIORITY_OR_OTHER||difference of LS means|-6.9|STANDARD_ERROR_OF_MEAN|3.12||0.0273|TWO_SIDED||||||mixed effect model|||Overall, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 psychological score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0273
72402683|NCT01480076|144311690|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 3, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 psychological score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
72512828|NCT01098461|144556233|NON_INFERIORITY_OR_EQUIVALENCE|The p-value is from a two-sided t-test for the difference in means. Dunnett's method is used to adjust for multiple comparisons.|Mean Difference (Final Values)|-1.1|||<|0.0001|TWO_SIDED|95.0|-1.43|-0.78|||t-test, 2 sided|||||-0.78|-1.43|<0.0001
72512829|NCT04570657|144556250|SUPERIORITY||LS mean difference|0.036||||0.267|TWO_SIDED|80.0|-0.038|0.111||One-sided p-value|MMRM||Tozorakimab Dose A - Placebo|||0.111|-0.038|0.267
72512830|NCT04570657|144556250|SUPERIORITY||LS mean difference|0.004||||0.473|TWO_SIDED|80.0|-0.071|0.079||One-sided p-value|MMRM||Tozorakimab Dose B - Placebo|||0.079|-0.071|0.473
72512831|NCT04570657|144556251|SUPERIORITY||LS mean difference|-0.012||||0.437|TWO_SIDED|80.0|-0.11|0.086||One-sided p-value|MMRM||Week 8: Tozorakimab Dose A - Placebo|||0.086|-0.110|0.437
72512832|NCT04570657|144556251|SUPERIORITY||LS mean difference|0.059||||0.221|TWO_SIDED|80.0|-0.039|0.157||One-sided p-value|MMRM||Week 8: Tozorakimab Dose B - Placebo|||0.157|-0.039|0.221
72512833|NCT04570657|144556251|SUPERIORITY||LS mean difference|-0.038||||0.308|TWO_SIDED|80.0|-0.136|0.06||One-sided p-value|MMRM||Week 16: Tozorakimab Dose A - Placebo|||0.060|-0.136|0.308
72512834|NCT04570657|144556251|SUPERIORITY||LS mean difference|-0.025||||0.372|TWO_SIDED|80.0|-0.122|0.072||One-sided p-value|MMRM||Week 16: Tozorakimab Dose B - Placebo|||0.072|-0.122|0.372
72512835|NCT04570657|144556254|SUPERIORITY||LS mean difference|-0.03||||0.416|TWO_SIDED|80.0|-0.215|0.154||One-sided p-value|MMRM||Tozorakimab Dose A - Placebo|||0.154|-0.215|0.416
72512836|NCT04570657|144556254|SUPERIORITY||LS mean difference|-0.047||||0.371|TWO_SIDED|80.0|-0.231|0.137||One-sided p-value|MMRM||Tozorakimab Dose B - Placebo|||0.137|-0.231|0.371
72512837|NCT04570657|144556255|SUPERIORITY||Odds Ratio (OR)|1.2||||0.612|TWO_SIDED|80.0|0.76|1.9|||Chi-squared|||||1.90|0.76|0.612
72512838|NCT04570657|144556255|SUPERIORITY||Odds Ratio (OR)|1.41||||0.348|TWO_SIDED|80.0|0.88|2.25|||Chi-squared|||||2.25|0.88|0.348
72512839|NCT04570657|144556256|SUPERIORITY||Odds Ratio (OR)|0.81||||0.575|TWO_SIDED|80.0|0.5|1.31|||Chi-squared|||||1.31|0.50|0.575
72567711|NCT00986180|144666940|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.95|||||TWO_SIDED|95.0|0.54|1.67|||Cochran-Mantel-Haenszel|||||1.67|0.54|
72512840|NCT04570657|144556256|SUPERIORITY||Odds Ratio (OR)|0.86||||0.679|TWO_SIDED|80.0|0.53|1.38|||Chi-squared|||||1.38|0.53|0.679
72512841|NCT04570657|144556257|SUPERIORITY||LS mean difference|0.002||||0.5|TWO_SIDED|80.0|-3.825|3.828||One-sided p-value|MMRM||SGRQ Activity Total Score: Tozorakimab Dose A - Placebo|||3.828|-3.825|0.500
72567712|NCT00986180|144666941|SUPERIORITY_OR_OTHER|||||||0.5828|||||||Log Rank|||||||0.5828
72512842|NCT04570657|144556257|SUPERIORITY||LS mean difference|-1.364||||0.324|TWO_SIDED|80.0|-5.198|2.47||One-sided p-value|MMRM||SGRQ Activity Total Score: Tozorakimab Dose B - Placebo|||2.470|-5.198|0.324
72512843|NCT04570657|144556257|SUPERIORITY||LS mean difference|-1.421||||0.248|TWO_SIDED|80.0|-4.103|1.26||One-sided p-value|MMRM||SGRQ Impacts Total Score: Tozorakimab Dose A - Placebo|||1.260|-4.103|0.248
72512844|NCT04570657|144556257|SUPERIORITY||LS mean difference|-1.694||||0.21|TWO_SIDED|80.0|-4.383|0.996||One-sided p-value|MMRM||SGRQ Impacts Total Score: Tozorakimab Dose B - Placebo|||0.996|-4.383|0.210
72512845|NCT04570657|144556257|SUPERIORITY||LS mean difference|0.691||||0.42|TWO_SIDED|80.0|-3.715|5.096||One-sided p-value|MMRM||SGRQ Symptoms Total Score: Tozorakimab Dose A - Placebo|||5.096|-3.715|0.420
72512846|NCT04570657|144556257|SUPERIORITY||LS mean difference|-3.15||||0.181|TWO_SIDED|80.0|-7.579|1.28||One-sided p-value|MMRM||SGRQ Symptoms Total Score: Tozorakimab Dose B - Placebo|||1.280|-7.579|0.181
72512847|NCT04570657|144556257|SUPERIORITY||LS mean difference|-0.663||||0.38|TWO_SIDED|80.0|-3.454|2.129||One-sided p-value|MMRM||SGRQ Total Score: Tozorakimab Dose A - Placebo|||2.129|-3.454|0.380
72512848|NCT04570657|144556257|SUPERIORITY||LS mean difference|-1.896||||0.192|TWO_SIDED|80.0|-4.694|0.903||One-sided p-value|MMRM||SGRQ Total Score: Tozorakimab Dose B - Placebo|||0.903|-4.694|0.192
72512849|NCT04570657|144556258|SUPERIORITY||Odds Ratio (OR)|0.93||||0.828|TWO_SIDED|80.0|0.59|1.46|||Chi-squared|||||1.46|0.59|0.828
72512850|NCT04570657|144556258|SUPERIORITY||Odds Ratio (OR)|1.07||||0.84|TWO_SIDED|80.0|0.68|1.7|||Chi-squared|||||1.70|0.68|0.840
72567713|NCT00986180|144666942|SUPERIORITY_OR_OTHER|||||||0.9084|||||||Log Rank|||||||0.9084
72567714|NCT03261960|144666973|NON_INFERIORITY|Non-inferiority margin was set at 10%.|||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
72576917|NCT00261443|144680715|SUPERIORITY_OR_OTHER_LEGACY|||||||0.85||95.0|||||Wilcoxon Rank Sum Test|||Baseline Treatment Comparison; Aripiprazole/Placebo||||0.850
72576918|NCT00261443|144680715|SUPERIORITY_OR_OTHER_LEGACY|||||||0.709||95.0|||||Wilcoxon Rank Sum Test|||Week 52 LOCF Treatment Comparison; Aripiprazole/Placebo||||0.709
72485710|NCT01086410|144499073|SUPERIORITY_OR_OTHER||Ratio of least square gometric mean|0.99|||||TWO_SIDED|95.0|0.87|1.12|||||Analysis was performed using Analysis of Covariance (ANCOVA) with covariates of region, sex, age, treatment, and the log of the Baseline values.|||1.12|0.87|
72485711|NCT01086410|144499073|SUPERIORITY_OR_OTHER||Ratio of least square gometric mean|0.97|||||TWO_SIDED|95.0|0.86|1.1|||||Analysis was performed using ANCOVA with covariates of region, sex, age, treatment, and the log of the Baseline values.|||1.10|0.86|
72485712|NCT01086410|144499073|SUPERIORITY_OR_OTHER||Ratio of least square gometric mean|0.34|||||TWO_SIDED|95.0|0.28|0.41|||||Analysis performed using ANCOVA with covariates of region, sex, age, treatment, and the log of the Baseline values.|||0.41|0.28|
72512851|NCT04570657|144556259|SUPERIORITY||Hazard Ratio (HR)|1.3||||0.239|TWO_SIDED|80.0|0.8|2.0||One-sided p-value|Regression, Cox|Cox regression model with treatment group, background medication, geographic region, and ICS total daily dose as covariates.||||2.0|0.8|0.239
72485713|NCT02953639|144499095|SUPERIORITY||Treatment Difference|-0.36||||0.73|TWO_SIDED|90.0|-2.11|1.38|||Mixed Models Analysis|||Week 12 Day 84||1.38|-2.11|0.730
72512852|NCT04570657|144556259|SUPERIORITY||Hazard Ratio (HR)|1.0||||0.461|TWO_SIDED|80.0|0.6|1.7||One-sided p-value|Regression, Cox|Cox regression model with treatment group, background medication, geographic region, and ICS total daily dose as covariates.||||1.7|0.6|0.461
72512853|NCT04570657|144556260|SUPERIORITY||Rate ratio|0.87||||0.346|TWO_SIDED|80.0|0.56|1.36||One-sided p-value|Negative binomial regression|||||1.36|0.56|0.346
72512854|NCT04570657|144556260|SUPERIORITY||Rate ratio|0.7||||0.166|TWO_SIDED|80.0|0.43|1.12||One-sided p-value|Negative binomial regression|||||1.12|0.43|0.166
72512855|NCT04570657|144556261|SUPERIORITY||Geometric LS mean ratio|0.869||||0.029|TWO_SIDED|80.0|0.791|0.956||One-sided p-value|MMRM|||||0.956|0.791|0.029
72512856|NCT04570657|144556261|SUPERIORITY||Geometric LS mean ratio|0.879||||0.04|TWO_SIDED|80.0|0.8|0.966||One-sided p-value|MMRM|||||0.966|0.800|0.040
72512857|NCT04570657|144556262|SUPERIORITY||LS mean difference|0.023||||0.385|TWO_SIDED|80.0|-0.078|0.124||One-sided p-value; alpha = 0.1|MMRM||Tozorakimab Dose A - Placebo|1 Exacerbation in Last 12 Months||0.124|-0.078|0.385
72512858|NCT04570657|144556262|SUPERIORITY||LS mean difference|-0.123||||0.06|TWO_SIDED|80.0|-0.224|-0.022||One-sided p-value; alpha = 0.1|MMRM||Tozorakimab Dose B - Placebo|1 Exacerbation in Last 12 Months||-0.022|-0.224|0.060
72512859|NCT04570657|144556262|SUPERIORITY||LS mean Difference|0.077||||0.186|TWO_SIDED|80.0|-0.034|0.187||One-sided p-value; alpha = 0.1|MMRM||Tozorakimab Dose A - Placebo|≥ 2 Exacerbation in Last 12 Months||0.187|-0.034|0.186
72512860|NCT04570657|144556262|SUPERIORITY||LS mean difference|0.212||||0.007|TWO_SIDED|80.0|0.102|0.322||One-sided p-value; alpha = 0.1|MMRM||Tozorakimab Dose B - Placebo|≥ 2 Exacerbation in Last 12 Months||0.322|0.102|0.007
72512861|NCT04570657|144556263|SUPERIORITY||Geometric LS Mean Ratio|0.63|||<|0.001|TWO_SIDED|80.0|0.559|0.71||One-sided p-value|MMRM|||Analysis at Week 16 based on MMRM which included fixed effects for baseline, background medication, geographic region, baseline ICS total daily dose, visit, treatment and the baseline by visit and treatment by visit interactions.||0.710|0.559|< 0.001
72485714|NCT02953639|144499095|SUPERIORITY||Treatment Difference|0.28||||0.793|TWO_SIDED|90.0|-1.47|2.02|||Mixed Models Analysis|||Week 24 Day 168||2.02|-1.47|0.793
72512862|NCT04570657|144556263|SUPERIORITY||Geometric LS Mean Ratio|0.675|||<|0.001|TWO_SIDED|80.0|0.599|0.76||One-sided p-value|MMRM|||Analysis at Week 16 based on MMRM which included fixed effects for baseline, background medication, geographic region, baseline ICS total daily dose, visit, treatment and the baseline by visit and treatment by visit interactions.||0.760|0.599|< 0.001
72512863|NCT01072539|144556266|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Statistical significant level: 0.05|Fisher Exact|||Comparison among subgroups of Infection Sites: cSSSI, cIAI, CAP, cIAI + cSSSI, and cIAI + CAP.||||<0.0001
72512864|NCT01072539|144556267|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0067||||||Statistical significant level: 0.05|Chi-squared|||Geriatrc: \<65 Years Versus (VS) Geriatrc: \>=65 Years||||0.0067
72512865|NCT01072539|144556267|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0412||||||Statistical significant level: 0.05|Chi-squared|||Comparison among Age categories: \<30 Years, 30 to 39 Years, 40 to 49 Years, 50 to 64 Years, and \>=65 Years.||||0.0412
72485715|NCT02953639|144499096|SUPERIORITY||Treatment Difference|-0.91||||0.556|TWO_SIDED|90.0|-3.46|1.64|||Mixed Models Analysis|||Week 12 Day 84 (Attention/Vigilance)||1.64|-3.46|0.556
72485716|NCT02953639|144499096|SUPERIORITY||Treatment Difference|-0.27||||0.848|TWO_SIDED|90.0|-2.59|2.05|||Mixed Models Analysis|||Week 24 Day 168 (Attention/Vigilance)||2.05|-2.59|0.848
72485717|NCT02953639|144499096|SUPERIORITY||Treatment Difference|0.04||||0.973|TWO_SIDED|90.0|-2.08|2.16|||Mixed Models Analysis|||Week 12 Day 84 (Reasoning and Problem Solving)||2.16|-2.08|0.973
72485718|NCT02953639|144499096|SUPERIORITY||Treatment Difference|0.57||||0.651|TWO_SIDED|90.0|-1.53|2.67|||Mixed Models Analysis|||Week 24 Day 168 (Reasoning and Problem Solving)||2.67|-1.53|0.651
72485719|NCT02953639|144499096|SUPERIORITY||Treatment Difference|-1.44||||0.35|TWO_SIDED|90.0|-3.89|1.08|||Mixed Models Analysis|||Week 12 Day 84 (Social Cognition)||1.08|-3.89|0.350
72512866|NCT01072539|144556267|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4792||||||Statistical significant level: 0.05|Chi-squared|||Sex: Male VS Sex: Female||||0.4792
72512867|NCT01072539|144556267|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9669||||||Statistical significant level: 0.05|Chi-squared|||Comparson among Duration of Disease categories: \<3 Months, \>=3 Months and \<6 Months, and \>=6 Months||||0.9669
72512868|NCT01072539|144556267|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0064||||||Statistical significant level: 0.05|Fisher Exact|||Comparison among subgroups of infection site: cSSSI, cIAI, CAP, cIAI + cSSSI, and cIAI + CAP.||||0.0064
72512869|NCT01072539|144556267|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Satistical significant level: 0.05|Chi-squared|||Comparison among severity of infection subgroups: Mild, Moderate, and Severe.||||<0.0001
72512870|NCT01072539|144556267|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Statistical significant level: 0.05|Chi-squared|||General Medical History: Yes VS General Medical History: No||||<0.0001
72512871|NCT01072539|144556267|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Statistical significant level: 0.05|Chi-squared|||General Medical History (Present): Yes VS General Medical History (Present): No||||<0.0001
72512872|NCT01072539|144556267|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0006||||||Statistical significant level: 0.05|Chi-squared|||General Medical History (Past): Yes VS General Medical History (Past): No||||0.0006
72512873|NCT01072539|144556267|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||Chi-squared|||Kidney Disorder: Yes VS Kidney Disorder: No||||<0.0001
72402684|NCT01480076|144311690|SUPERIORITY_OR_OTHER|||||||0.9091|||||||mixed effect model|||Month 3, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 psychological score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.9091
72624105|NCT01892189|144778533|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1673|STANDARD_ERROR_OF_MEAN|0.17458||0.345|TWO_SIDED|95.0|-0.1875|0.5221|||ANOVA||Difference between least square means of TAK-063 10 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Left Posterior Cingulate Cortex: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.5221|-0.1875|0.345
72485720|NCT02953639|144499096|SUPERIORITY||Treatment Difference|2.18||||0.121|TWO_SIDED|90.0|-0.14|4.5|||Mixed Models Analysis|||Week 24 Day 168 (Social Cognition)||4.50|-0.14|0.121
72485721|NCT02953639|144499096|SUPERIORITY||Treatment Difference|-0.13||||0.911|TWO_SIDED|90.0|-2.1|1.83|||Mixed Models Analysis|||Week 12 Day 84 (Speed of Processing)||1.83|-2.10|0.911
72485722|NCT02953639|144499096|SUPERIORITY||Treatment Difference|0.02||||0.987|TWO_SIDED|90.0|-1.99|2.03|||Mixed Models Analysis|||Week 24 Day 168 (Speed of Processing)||2.03|-1.99|0.987
72485723|NCT02953639|144499096|SUPERIORITY||Treatment Difference|-0.34||||0.803|TWO_SIDED|90.0|-2.62|1.93|||Mixed Models Analysis|||Week 12 Day 84 (Verbal Learning)||1.93|-2.62|0.803
72485724|NCT02953639|144499096|SUPERIORITY||Treatment Difference|-0.94||||0.502|TWO_SIDED|90.0|-3.26|1.38|||Mixed Models Analysis|||Week 24 Day 168 (Verbal Learning)||1.38|-3.26|0.502
72485725|NCT02953639|144499096|SUPERIORITY||Treatment Difference|-0.11||||0.945|TWO_SIDED|90.0|-2.74|2.52|||Mixed Models Analysis|||Week 12 Day 84 (Visual Learning)||2.52|-2.74|0.945
72485726|NCT02953639|144499096|SUPERIORITY||Treatment Difference|1.11||||0.488|TWO_SIDED|90.0|-1.54|3.76|||Mixed Models Analysis|||Week 24 Day 168 (Visual Learning)||3.76|-1.54|0.488
72485727|NCT02953639|144499096|SUPERIORITY||Treatment Difference|-1.37||||0.262|TWO_SIDED|90.0|-3.38|0.64|||Mixed Models Analysis|||Week 12 Day 84 (Working Memory)||0.64|-3.38|0.262
72485728|NCT02953639|144499096|SUPERIORITY||Treatment Difference|-0.89||||0.489|TWO_SIDED|90.0|-3.01|1.23|||Mixed Models Analysis|||Week 24 Day 168 (Working Memory)||1.23|-3.01|0.489
72485729|NCT02953639|144499097|SUPERIORITY||Treatment Difference|-1.63||||0.211|TWO_SIDED|90.0|-3.78|0.52|||Mixed Models Analysis|||Week 12 Day 84 (VPA I total raw score)||0.52|-3.78|0.211
72485730|NCT02953639|144499097|SUPERIORITY||Treatment Difference|0.35||||0.787|TWO_SIDED|90.0|-1.81|2.52|||Mixed Models Analysis|||Week 24 Day 168 (VPA I total raw score)||2.52|-1.81|0.787
72485731|NCT02953639|144499097|SUPERIORITY||Treatment Difference|0.28||||0.477|TWO_SIDED|90.0|-0.37|0.94|||Mixed Models Analysis|||Week 12 Day 84 (VPA II total raw score)||0.94|-0.37|0.477
72485732|NCT02953639|144499097|SUPERIORITY||Treatment Difference|0.91||||0.028|TWO_SIDED|90.0|0.23|1.58|||Mixed Models Analysis|||Week 24 Day 168 (VPA II total raw score)||1.58|0.23|0.028
72485733|NCT02953639|144499097|SUPERIORITY||Treatment Difference|-0.3||||0.683|TWO_SIDED|90.0|-1.51|0.91|||Mixed Models Analysis|||Week 12 Day 84 (VPA II recognition total raw score)||0.91|-1.51|0.683
72485734|NCT02953639|144499097|SUPERIORITY||Treatment Difference|0.04||||0.954|TWO_SIDED|90.0|-1.13|1.22|||Mixed Models Analysis|||Week 24 Day 168 (VPA II recognition total raw score)||1.22|-1.13|0.954
72485735|NCT02953639|144499098|SUPERIORITY||Treatment Difference|1.45||||0.164|TWO_SIDED|90.0|-0.27|3.17|||Mixed Models Analysis|||Week 12 Day 84 (LM I)||3.17|-0.27|0.164
72485736|NCT02953639|144499098|SUPERIORITY||Treatment Difference|0.56||||0.559|TWO_SIDED|90.0|-1.02|2.14|||Mixed Models Analysis|||Week 24 Day 168 (LM I)||2.14|-1.02|0.559
72485737|NCT02953639|144499098|SUPERIORITY||Treatment Difference|0.12||||0.912|TWO_SIDED|90.0|-1.7|1.94|||Mixed Models Analysis|||Week 12 Day 84 (LM II)||1.94|-1.70|0.912
72485738|NCT02953639|144499098|SUPERIORITY||Treatment Difference|-0.36||||0.706|TWO_SIDED|90.0|-1.93|1.22|||Mixed Models Analysis|||Week 24 Day 168 (LM II)||1.22|-1.93|0.706
72485739|NCT02953639|144499099|SUPERIORITY||Treatment Difference|1.04||||0.527|TWO_SIDED|90.0|0.94|1.15|||Mixed Models Analysis|||Week 12 Day 84||1.15|0.94|0.527
72485740|NCT02953639|144499099|SUPERIORITY||Treatment Difference|1.04||||0.636|TWO_SIDED|90.0|0.92|1.17|||Mixed Models Analysis|||Week 24 Day 168||1.17|0.92|0.636
72485741|NCT02953639|144499100|SUPERIORITY||Treatment Difference|-1.36||||0.323|TWO_SIDED|90.0|-3.63|0.91|||Mixed Models Analysis|||Week 12 Day 84||0.91|-3.63|0.323
72485742|NCT02953639|144499100|SUPERIORITY||Treatment Difference|-0.95||||0.579|TWO_SIDED|90.0|-3.77|1.88|||Mixed Models Analysis|||Week 24 Day 168||1.88|-3.77|0.579
72485743|NCT02953639|144499101|SUPERIORITY||Treatment Difference|-0.67||||0.493|TWO_SIDED|90.0|-2.27|0.94|||Mixed Models Analysis|||Week 12 Day 84||0.94|-2.27|0.493
72485744|NCT02953639|144499101|SUPERIORITY||Treatment Difference|-0.12||||0.926|TWO_SIDED|90.0|-2.32|2.07|||Mixed Models Analysis|||Week 24 Day 168||2.07|-2.32|0.926
72485745|NCT02953639|144499102|SUPERIORITY||Treatment Difference|-0.02||||0.839|TWO_SIDED|90.0|-0.22|0.17|||Mixed Models Analysis|||Week 12 Day 84||0.17|-0.22|0.839
72485746|NCT02953639|144499102|SUPERIORITY||Treatment Difference|-0.06||||0.625|TWO_SIDED|90.0|-0.27|0.15|||Mixed Models Analysis|||Week 24 Day 168||0.15|-0.27|0.625
72485747|NCT02953639|144499103|SUPERIORITY||Treatment Difference|-0.03||||0.865|TWO_SIDED|90.0|-0.28|0.23|||Mixed Models Analysis|||Week 12 Day 84||0.23|-0.28|0.865
72485748|NCT02953639|144499103|SUPERIORITY||Treatment Difference|-0.01||||0.964|TWO_SIDED|90.0|-0.31|0.29|||Mixed Models Analysis|||Week 24 Day 168||0.29|-0.31|0.964
72485749|NCT02953639|144499104|SUPERIORITY||Treatment Difference|3.27||||0.142|TWO_SIDED|90.0|-0.4|6.95|||Mixed Models Analysis|||Week 12 Day 84 (SQLS Cognition \& Vitality Score)||6.95|-0.40|0.142
72485750|NCT02953639|144499104|SUPERIORITY||Treatment Difference|-2.32||||0.416|TWO_SIDED|90.0|-7.04|2.4|||Mixed Models Analysis|||Week 24 Day 168 (SQLS Cognition \& Vitality Score)||2.40|-7.04|0.416
72624106|NCT01892189|144778533|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1504|STANDARD_ERROR_OF_MEAN|0.16583||0.371|TWO_SIDED|95.0|-0.4874|0.1866|||ANOVA||Difference between least square means of TAK-063 30 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Left Posterior Cingulate Cortex: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.1866|-0.4874|0.371
72485751|NCT02953639|144499104|SUPERIORITY||Treatment Difference|1.98||||0.394|TWO_SIDED|90.0|-1.86|5.83|||Mixed Models Analysis|||Week 12 Day 84 (SQLS Psychosocial Score)||5.83|-1.86|0.394
72485752|NCT02953639|144499104|SUPERIORITY||Treatment Difference|0.71||||0.776|TWO_SIDED|90.0|-3.44|4.87|||Mixed Models Analysis|||Week 24 Day 168 (SQLS Psychosocial Score)||4.87|-3.44|0.776
72485753|NCT02953639|144499104|SUPERIORITY||Treatment Difference|2.43||||0.254|TWO_SIDED|90.0|-1.09|5.94|||Mixed Models Analysis|||Week 12 Day 84 (SQLS Total Score)||5.94|-1.09|0.254
72485754|NCT02953639|144499104|SUPERIORITY||Treatment Difference|-0.57||||0.816|TWO_SIDED|90.0|-4.64|3.5|||Mixed Models Analysis|||Week 24 Day 168 (SQLS Total Score)||3.50|-4.64|0.816
72485755|NCT04196803|144499114|SUPERIORITY||||||<|0.05|||||||Regression, Linear|P value was calculated using general linear model adjusted for age, sex, and baseline level||||||<0.05
72485756|NCT04196803|144499115|SUPERIORITY||||||>|0.05|||||||Regression, Linear|P value was calculated using general linear model adjusted for age, sex, and baseline level||||||>0.05
72485757|NCT04196803|144499116|SUPERIORITY||||||>|0.05|||||||Regression, Linear|P value was calculated using general linear model adjusted for age, sex, and baseline level||||||>0.05
72485758|NCT04196803|144499117|SUPERIORITY||||||=|0.08|||||||Regression, Linear|P value was calculated using general linear model adjusted for age, sex, and baseline level||||||=0.08
72485759|NCT05097716|144499145|EQUIVALENCE|90% CI|ratio of adjusted geometric means|103.01|||||TWO_SIDED|90.0|96.66|109.77|||||The comparison was Test vs. Reference (Ritlecitinib + Tolbutamide vs. Tolbutamide).|||109.77|96.66|
72512874|NCT01072539|144556267|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Statistical significant level: 0.05|Chi-squared|||Liver Disorder: Yes VS Liver Disorder: No||||<0.0001
72485760|NCT05097716|144499146|EQUIVALENCE|90% CI|ratio of adjusted geometric means|99.05|||||TWO_SIDED|90.0|92.01|106.62|||||The comparison was Test vs. Reference (Ritlecitinib + Tolbutamide vs. Tolbutamide).|||106.62|92.01|
72512875|NCT01072539|144556267|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0153||||||Statistical significant level: 0.05|Chi-squared|||Comparison among subgroups of Total Treatment Period of Tygacil: \<7 Days, 7 to 14 Days, and \>14 Days||||0.0153
72512876|NCT01072539|144556267|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Statistical significant level 0.05|Fisher Exact|||Comparison among subgroups of Mean Daily Dose of Tygacil: \<50 mg, 50 to \<100 mg, 100 to \<200 mg, and \>=200 mg.||||<0.0001
72485761|NCT02319668|144499166|SUPERIORITY_OR_OTHER||Least square (LS) Mean difference|0.2||||0.2965|TWO_SIDED|95.0|-0.18|0.58|||ANCOVA|ANCOVA with treatment as factor and baseline as covariate.|Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|||0.58|-0.18|0.2965
72485762|NCT01338415|144499186|OTHER||Hazard Ratio (HR)|1.438|||||TWO_SIDED|95.0|0.47|4.399|||Regression, Cox|||Post-hoc analysis: Cox proportional hazard regression univariate model with treatment as covariate (treatment-only univariate model)||4.399|0.470|
72485763|NCT01338415|144499186|OTHER|||||||0.0526||||||p-value \<= 10% indicates that the covariate WHO FC at baseline is related to the time to PAH worsening|Regression, Cox|||Post-hoc analysis: Cox proportional hazard regression univariate model with WHO FC at baseline (FC III vs FC I/II) as covariate||||0.0526
72485764|NCT01338415|144499186|OTHER||Hazard Ratio (HR)|1.169||||||95.0|0.371|3.681|||Regression, Cox|||Post-hoc analysis: Treatment Hazard Ratio (HR) in the multivariate model with treatment and WHO FC at baseline as covariates||3.681|0.371|
72485765|NCT01338415|144499186|SUPERIORITY|||||||0.076||||||p-value \<= 10% indicates an improvement in model fit|log(e) likelihood ratio|||Test of improvement in model fit from the univariate to the multivariate model with WHO FC at baseline as covariate||||0.076
72485766|NCT01338415|144499187|OTHER||Hazard Ratio (HR)|1.935|||||TWO_SIDED|95.0|0.582|6.428|||Regression, Cox|||Post-hoc analysis: Cox proportional hazard regression univariate model with treatment as covariate (treatment-only univariate model)||6.428|0.582|
72485767|NCT01338415|144499187|OTHER|||||||0.0085|||||||Regression, Cox|p-value \<= 10% indicates that the covariate is related to the time to the time to death up to end-of-study||Post-hoc analysis: Cox proportional hazard regression univariate model with WHO FC at baseline (FC III vs FC I/II) as covariate||||0.0085
72485768|NCT01338415|144499187|OTHER||Hazard Ratio (HR)|1.487|||||TWO_SIDED|95.0|0.437|5.052|||Regression, Cox|||Post-hoc analysis: Treatment Hazard Ratio (HR) in the multivariate model with treatment and WHO FC at baseline as covariates||5.052|0.437|
72485769|NCT01338415|144499187|SUPERIORITY|||||||0.014|||||||log(e) likelihood ratio|p-value \<= 10% indicates an improvement in model fit||Test of the improvement in model fit from the univariate to the multivariate model with WHO FC at baseline as covariate||||0.014
72485770|NCT01970488|144499213|NON_INFERIORITY_OR_EQUIVALENCE|Clinical equivalence was evaluated by comparing the 2-sided 95% confidence interval (CI) of the difference of PASI percent improvement from baseline to Week 16 between ABP 501 and adalimumab with an equivalence margin of ± 15.|Least Squares (LS) Mean Difference|-2.18|||||TWO_SIDED|95.0|-7.39|3.02||||||||3.02|-7.39|
72485771|NCT01177384|144499242|SUPERIORITY_OR_OTHER||Difference in least squares mean|-0.62|||<|0.001|TWO_SIDED|95.0|-0.79|-0.44||The ANCOVA model included terms for treatment and prior antihyperglycemic agent (AHA) therapy status (on acarbose monotherapy, or on acarbose in combination with other AHA(s)) and a covariate for baseline A1C.|ANCOVA|||||-0.44|-0.79|<.001
72512877|NCT01072539|144556267|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0376||||||Statistical significant level: 0.05|Chi-squared|||Past Medication and Therapy: Yes VS Past Medication and Therapy: No||||0.0376
72512878|NCT01072539|144556267|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Statistical significant level: 0.05|Chi-squared|||Concomitant Medications: Yes VS Concomitant Medications: No||||<0.0001
72512879|NCT02856269|144556269|OTHER|Wilcoxon rank sum tests, X2 tests, Fisher exact tests, Kolmogorov-Smirnov|Cohen's D value|0.8|||||TWO_SIDED||||||||The Cohen's d is calculated after Box-Cox transformation. Small effect \<= 0.2, Medium effect \[0.3, 0.8\]; Large effect \>0.8|||||
72542482|NCT00106028|144614698|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.543||||0.0799|TWO_SIDED|95.0|0.274|1.076||Long Bone Non-Vertebral Fracture|Wald Test|Hazard Ratio and 95% CI based on Anderson-Gill mean intensity model stratified by age group with treatment and pooled-country as covariates.||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.||1.076|0.274|0.0799
72402685|NCT01480076|144311690|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 3, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 psychological score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
72402686|NCT01480076|144311690|SUPERIORITY_OR_OTHER|||||||0.7718|||||||mixed effect model|||Month 3, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 psychological score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.7718
72402687|NCT01480076|144311690|SUPERIORITY_OR_OTHER||difference of LS means|-9.2|STANDARD_ERROR_OF_MEAN|2.11|<|0.0001|TWO_SIDED||||||mixed effect model|||Month 3, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 psychological score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
72485772|NCT01177384|144499243|SUPERIORITY_OR_OTHER||Difference in least squares mean|-14.4|||<|0.001|TWO_SIDED|95.0|-21.8|-7.0||The ANCOVA model included terms for treatment and prior AHA therapy status (on acarbose monotherapy, or on acarbose in combination with other AHA(s)) and a covariate for baseline FPG.|ANCOVA|||||-7.0|-21.8|<.001
72485773|NCT01849497|144499246|SUPERIORITY_OR_OTHER||Treatment Difference|-6.8|||||TWO_SIDED|95.0|-16.3|2.0||||||||2.0|-16.3|
72512880|NCT01752842|144556279|SUPERIORITY|Power calculation is based on assumption that treatment with Fenofibrate will lead to 11% decrease in plasma TG and ceramide biomarkers. We also assume that there will be no significant change in ceramides without intervention. Based on these assumptions, 86 subjects are required to have 90% chance of detecting a decrease in the primary outcome measure from 1.29 in the placebo group to 1.15 in the Fenofibrate group.|Mean Difference (Final Values)|-0.75||||0.07|TWO_SIDED|95.0|-1.56|0.04||This P-value is based on ANCOVA.|ANCOVA||ANCOVA was used to compare mean change of cardiac diastolic function adjusting for body fat percent, baseline values of BMI, diastolic/systolic blood pressure, HbA1c, fasting glucose, triglycerides, ethnicity, gender and race.|Null hypothesis is no difference of mean change of cardiac diastolic function as measured by E' (cm/s) between placebo and Fenofibrate.|Two-sample t-test was used to compare baseline mean values of biomarkers. All statistical tests are two-sided at significance level 0.05.|0.04|-1.56|0.07
72576919|NCT00261443|144680715|SUPERIORITY_OR_OTHER_LEGACY|||||||0.326||95.0|||||Wilcoxon Rank Sum Test|||Highest Value Treatment Comparison; Aripiprazole/Placebo||||0.326
72576920|NCT00261443|144680715|SUPERIORITY_OR_OTHER_LEGACY|||||||0.201||95.0|||||Wilcoxon Rank Sum Test|||Lowest Value Treatment Comparison; Aripiprazole/Placebo||||0.201
72402688|NCT01480076|144311690|SUPERIORITY_OR_OTHER||difference of LS means|-10.1|STANDARD_ERROR_OF_MEAN|3.5||0.0038|TWO_SIDED||||||mixed effect model|||Month 3, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 psychological score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0038
72402689|NCT01480076|144311690|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 6, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 psychological score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
72402690|NCT01480076|144311690|SUPERIORITY_OR_OTHER|||||||0.272|||||||mixed effect model|||Month 6, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 psychological score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.2720
72402691|NCT01480076|144311690|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 6, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 psychological score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
72402692|NCT01480076|144311690|SUPERIORITY_OR_OTHER|||||||0.4767|||||||mixed effect model|||Month 6, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 psychological score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.4767
72402693|NCT01480076|144311690|SUPERIORITY_OR_OTHER||difference of LS means|-4.5|STANDARD_ERROR_OF_MEAN|2.32||0.0553|TWO_SIDED||||||mixed effect model|||Month 6, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 psychological score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0553
72485774|NCT01849497|144499247|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-3.7|STANDARD_ERROR_OF_MEAN|3.38|||TWO_SIDED|95.0|-10.38|2.99||||||||2.99|-10.38|
72485775|NCT00307333|144499262|SUPERIORITY_OR_OTHER|||||||0.08||95.0|||||t-test, 2 sided|||||||0.08
72485776|NCT00307333|144499263|SUPERIORITY_OR_OTHER|||||||0.47||95.0|||||t-test, 2 sided|||||||0.47
72485777|NCT00307333|144499264|SUPERIORITY_OR_OTHER|||||||0.31||95.0|||||t-test, 2 sided|||||||0.31
72485778|NCT00307333|144499265|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.78|||||TWO_SIDED|95.0|0.61|0.99|||||HR = hazard for intervention / hazard for control|||0.99|0.61|
72402694|NCT01480076|144311690|SUPERIORITY_OR_OTHER||difference of LS means|-6.9|STANDARD_ERROR_OF_MEAN|3.73||0.0632|TWO_SIDED||||||mixed effect model|||Month 6, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 psychological score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0632
72485779|NCT01621542|144499285|OTHER|None specified||||||||||||||||The MTD could not be established for this study as no DLTs occurred at doses up to and including 27.0 mg|The MTD could not be established for this study as no DLTs occurred at doses up to and including 27.0 mg|||
72512881|NCT01752842|144556280|SUPERIORITY|Power calculation is based on assumption that treatment with Fenofibrate will lead to 11% decrease in plasma TG and ceramide biomarkers. We also assume that there will be no significant change in ceramides without intervention. Based on these assumptions, 86 subjects are required to have 90% chance of detecting a decrease in the primary outcome measure from 1.29 in the placebo group to 1.15 in the Fenofibrate group.|Mean Difference (Final Values)|0.0058||||0.8128|TWO_SIDED|95.0|-0.0418|0.0543||This P-value is based on ANCOVA.|ANCOVA||ANCOVA was used to compare mean change of outcome adjusting for body fat percent, demographic variables and baseline biomarkers.|Null hypothesis is no difference of mean change of fractional shortening percent between placebo and Fenofibrate.|Two-sample t-test was used to compare baseline mean values of biomarkers. All statistical tests are two-sided at significance level 0.05.|0.0543|-0.0418|0.8128
72576921|NCT00261443|144680716|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.47||||0.491|TWO_SIDED|95.0|-0.87|1.81||ANOVA model, controlling for treatment and mood stabilizer, is used for baseline. ANCOVA model, controlling for treatment, mood stabilizer, and baseline value, is used for mean change from baseline.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences and p-values are based on the ANOVA/ANCOVA model.||Week 52 (LOCF) Treatment Difference||1.81|-0.87|0.491
72485780|NCT02632721|144499304|OTHER||Probability of DLT rate in [0.16, 0.33)|0.081|||||||||||||Posterior probability of the DLT rate lying in the interval \[0.16, 0.33) (target dosing) is reported.|Bayesian logistic regression model (BLRM) with overdose control was used to determine the maximum tolerated dose (MTD), defined as highest dose with less than 25% risk of the true DLT rate being equal to or above 33%.||||
72485781|NCT02632721|144499304|OTHER||Probability of DLT rate in [0.33, 1)|0.0|||||||||||||Posterior probability of the DLT rate lying in the interval \[0.33,1) (overdosing) is reported.|Bayesian logistic regression model (BLRM) with overdose control was used to determine the maximum tolerated dose (MTD), defined as highest dose with less than 25% risk of the true DLT rate being equal to or above 33%.||||
72485782|NCT02632721|144499304|OTHER||Probability of DLT rate in [0.16, 0.33)|0.028|||||||||||||Posterior probability of the DLT rate lying in the interval \[0.16, 0.33) (target dosing) is reported.|Bayesian logistic regression model (BLRM) with overdose control was used to determine the maximum tolerated dose (MTD), defined as highest dose with less than 25% risk of the true DLT rate being equal to or above 33%.||||
72485783|NCT02632721|144499304|OTHER||Posterior probability of the DLT rate ly|0.0|||||||||||||Posterior probability of the DLT rate lying in the interval \[0.33,1) (overdosing) is reported.|Bayesian logistic regression model (BLRM) with overdose control was used to determine the maximum tolerated dose (MTD), defined as highest dose with less than 25% risk of the true DLT rate being equal to or above 33%.||||
72485784|NCT02632721|144499304|OTHER||Probability of DLT rate in [0.16, 0.33)|0.012|||||||||||||Posterior probability of the DLT rate lying in the interval \[0.16, 0.33) (target dosing) is reported.|Bayesian logistic regression model (BLRM) with overdose control was used to determine the maximum tolerated dose (MTD), defined as highest dose with less than 25% risk of the true DLT rate being equal to or above 33%.||||
72485785|NCT02632721|144499304|OTHER||Probability of DLT rate in [0.33, 1)|0.0|||||||||||||Posterior probability of the DLT rate lying in the interval \[0.33,1) (overdosing) is reported.|Bayesian logistic regression model (BLRM) with overdose control was used to determine the maximum tolerated dose (MTD), defined as highest dose with less than 25% risk of the true DLT rate being equal to or above 33%.||||
72485786|NCT02663271|144499317|SUPERIORITY|We used one-sample log rank test to compare to historical control.|Hazard Ratio (HR)|0.3|||<|0.001|TWO_SIDED||||||Log Rank|||||||<0.001
72485787|NCT03346057|144499324|OTHER||Estimated Difference in percentage|-6.7||||0.026|TWO_SIDED|95.0|-17.5|-0.8|||Stratified Miettinen & Nurminen method|||Miettinen \& Nurminen method stratified by neuromuscular blocking agent (NMBA) and American Society of Anesthesiologists (ASA) class was used to provide estimated between-treatment difference, 95% confidence interval, and p-value||-0.8|-17.5|0.026
72485788|NCT03346057|144499324|OTHER||Estimated Difference in percentage|-6.2||||0.058|TWO_SIDED|95.0|-17.3|0.2|||Stratified Miettinen & Nurminen method|||Miettinen \& Nurminen method stratified by NMBA and ASA was used to provide estimated between-treatment difference, 95% confidence interval, and p-value||0.2|-17.3|0.058
72485789|NCT03346057|144499324|OTHER||Estimated Difference in percentage|-2.0||||0.73|TWO_SIDED|95.0|-17.8|8.6|||Stratified Miettinen & Nurminen method|||Miettinen \& Nurminen method stratified by NMBA and ASA was used to provide estimated between-treatment difference, 95% confidence interval, and p-value||8.6|-17.8|0.730
72485790|NCT03346057|144499325|OTHER||Estimated Difference in percentage|-14.9||||0.007|TWO_SIDED|95.0|-28.8|-4.0|||Stratified Miettinen & Nurminen method|||Miettinen \& Nurminen method stratified by NMBA and ASA was used to provide estimated between-treatment difference, 95% confidence interval, and p-value||-4.0|-28.8|0.007
72485791|NCT03346057|144499325|OTHER||Estimated Difference in percentage|-12.2||||0.036|TWO_SIDED|95.0|-26.1|-0.8|||Stratified Miettinen & Nurminen method|||Miettinen \& Nurminen method stratified by NMBA and ASA was used to provide estimated between-treatment difference, 95% confidence interval, and p-value||-0.8|-26.1|0.036
72485792|NCT03346057|144499325|OTHER||Estimated Difference in percentage|-9.9||||0.158|TWO_SIDED|95.0|-27.6|3.6|||Stratified Miettinen & Nurminen method|||Miettinen \& Nurminen method stratified by NMBA and ASA was used to provide estimated between-treatment difference, 95% confidence interval, and p-value||3.6|-27.6|0.158
72485793|NCT03346057|144499326|OTHER||Estimated Difference in percentage|-0.9||||0.637|TWO_SIDED|95.0|-9.4|4.0|||Stratified Miettinen & Nurminen method|||Miettinen \& Nurminen method stratified by NMBA and ASA was used to provide estimated between-treatment difference, 95% confidence interval, and p-value||4.0|-9.4|0.637
72485794|NCT03346057|144499326|OTHER||Estimated Difference in percentage|-2.1||||0.134|TWO_SIDED|95.0|-10.6|1.5|||Stratified Miettinen & Nurminen method|||Miettinen \& Nurminen method stratified by NMBA and ASA was used to provide estimated between-treatment difference, 95% confidence interval, and p-value||1.5|-10.6|0.134
72485795|NCT03346057|144499326|OTHER||Estimated Difference in percentage|-1.7||||0.577|TWO_SIDED|95.0|-14.7|5.8|||Stratified Miettinen & Nurminen method|||Miettinen \& Nurminen method stratified by NMBA and ASA was used to provide estimated between-treatment difference, 95% confidence interval, and p-value||5.8|-14.7|0.577
72485796|NCT03346057|144499327|OTHER||Estimated Difference in percentage|6.2|||||TWO_SIDED|95.0|-2.6|18.5||||||Miettinen \& Nurminen method stratified by NMBA and ASA was used to provide estimated between-treatment difference and 95% confidence interval||18.5|-2.6|
72485797|NCT03346057|144499327|OTHER||Estimated Difference in percentage|0.5|||||TWO_SIDED|95.0|-9.3|13.1||||||Miettinen \& Nurminen method stratified by NMBA and ASA was used to provide estimated between-treatment difference and 95% confidence interval||13.1|-9.3|
72485798|NCT03346057|144499327|OTHER||Estimated Difference in percentage|2.0|||||TWO_SIDED|95.0|-8.4|17.7||||||Miettinen \& Nurminen method stratified by NMBA and ASA was used to provide estimated between-treatment difference and 95% confidence interval||17.7|-8.4|
72485799|NCT03346057|144499328|OTHER||Estimated Difference in percentage|5.6|||||TWO_SIDED|95.0|-5.5|14.3||||||Miettinen \& Nurminen method stratified by NMBA and ASA was used to provide estimated between-treatment difference and 95% confidence interval||14.3|-5.5|
72485800|NCT03346057|144499328|OTHER||Estimated Difference in percentage|1.5|||||TWO_SIDED|95.0|-9.2|9.3||||||Miettinen \& Nurminen method stratified by NMBA and ASA was used to provide estimated between-treatment difference and 95% confidence interval||9.3|-9.2|
72485801|NCT03346057|144499328|OTHER||Estimated Difference in percentage|0.9|||||TWO_SIDED|95.0|-15.1|12.7||||||Miettinen \& Nurminen method stratified by NMBA and ASA was used to provide estimated between-treatment difference and 95% confidence interval||12.7|-15.1|
72485802|NCT03346057|144499329|OTHER||Estimated Difference in percentage|-2.1|||||TWO_SIDED|95.0|-11.8|3.8||||||The percentage of participants experiencing one or more ECIs was compared between the Sugammadex 2 mg/kg arm and the Neostigmine plus Glycopyrrolate arm. Miettinen \& Nurminen method stratified by NMBA and ASA was used to provide estimated between-treatment difference and 95% confidence interval||3.8|-11.8|
72485803|NCT03346057|144499329|OTHER||Estimated Difference in percentage|1.8|||||TWO_SIDED|95.0|-8.1|8.4||||||The percentage of participants experiencing one or more ECIs was compared between the Sugammadex 4 mg/kg arm and the Neostigmine plus Glycopyrrolate arm. Miettinen \& Nurminen method stratified by NMBA and ASA was used to provide estimated between-treatment difference and 95% confidence interval||8.4|-8.1|
72485804|NCT03346057|144499329|OTHER||Estimated Difference in percentage|1.1|||||TWO_SIDED|95.0|-13.5|11.1||||||The percentage of participants experiencing one or more ECIs was compared between the Sugammadex 16 mg/kg arm and the Neostigmine plus Glycopyrrolate arm. Miettinen \& Nurminen method stratified by NMBA and ASA was used to provide estimated between-treatment difference and 95% confidence interval||11.1|-13.5|
72512882|NCT01752842|144556281|SUPERIORITY|Power calculation is based on assumption that treatment with Fenofibrate will lead to 11% decrease in plasma TG and ceramide biomarkers. We also assume that there will be no significant change in ceramides without intervention. Based on these assumptions, 86 subjects are required to have 90% chance of detecting a decrease in the primary outcome measure from 1.29 in the placebo group to 1.15 in the Fenofibrate group.|Mean Difference (Final Values)|-1.79||||0.0034|TWO_SIDED|95.0|-2.93|-0.65||This P-value is based on ANCOVA.|ANCOVA|ANCOVA was used to compare mean change of outcome adjusting for body fat percent, demographic variables and baseline biomarkers.||Null hypothesis is no difference of mean change of C24:0/C16:0 ceramide ratio between placebo and Fenofibrate.|Two-sample t-test was used to compare baseline mean values of biomarkers. All statistical tests are two-sided at significance level 0.05.|-0.65|-2.93|0.0034
72512883|NCT01683071|144556282|SUPERIORITY||LSMD|2.9||||0.9494|TWO_SIDED|95.0|-88.0|94.0|||ANCOVA|||||94|-88|0.9494
72402695|NCT01480076|144311690|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 9, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 psychological score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
72485805|NCT02456662|144499332|SUPERIORITY|Based on previous work as well as anecdotal data from our clinic population, we expect vomiting to occur in approximately 30% of our patients who take their doxycycline the night before their procedure. To have 80% power to detect a 50% decrease in nausea and vomiting, we will need 122 patients in each arm of the study.||||||0|||||||Chi-squared|||||||0.00
72485806|NCT01353079|144499342|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.834|||<|0.05|TWO_SIDED|95.0|-1.298|-0.369|||ANCOVA|||||-0.369|-1.298|<0.05
72512884|NCT01683071|144556282|SUPERIORITY||LSMD|-103.3||||0.0237|TWO_SIDED|95.0|-192.0|-14.0|||ANCOVA|||||-14|-192|0.0237
72485807|NCT01353079|144499343|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.857|||<|0.05|TWO_SIDED|95.0|-1.388|-0.326|||ANCOVA|||||-0.326|-1.388|<0.05
72485808|NCT01353079|144499344|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.771|||<|0.05|TWO_SIDED|95.0|-1.213|-0.329|||ANCOVA|||||-0.329|-1.213|<0.05
72485809|NCT01353079|144499345|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.788|||<|0.05|TWO_SIDED|95.0|-1.291|-0.284|||ANCOVA|||||-0.284|-1.291|<0.05
72485810|NCT02347488|144499348|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.1|STANDARD_DEVIATION|1.8|<|0.001|TWO_SIDED|95.0|2.88|3.32|||ANCOVA|||Average displacement difference in cm, tape vs. tube-holder. 17 participants was the estimated enrollment needed to detect a difference of 1 SD from the mean between the 2 fixation techniques at 80% power; additional enrollment was included to increase the power of results and to include a larger variety of patients undergoing different surgical procedures.||3.32|2.88|<0.001
72402696|NCT01480076|144311690|SUPERIORITY_OR_OTHER|||||||0.9398|||||||mixed effect model|||Month 9, Non-responder (Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 psychological score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.9398
72485811|NCT04223791|144499363|NON_INFERIORITY|Non-inferiority is concluded if the upper bound of the 2-sided multiplicity-adjusted 95% CI for the difference in the percentage of participants with HIV-1 RNA ≥50 copies/mL (DOR/ISL-BIC/FTC/TAF) is less than 4 percentage points.|Estimated difference|0.31|||<|0.001|TWO_SIDED|95.0|-1.19|1.96||p-value for the treatment differences in percent response were calculated using the unstratified Miettinen and Nurminen method.|Unstratified Miettinen and Nurminen||Treatment difference for DOR/ISL group-BIC/FTC/TAF group.|||1.96|-1.19|<.001
72485812|NCT04223791|144499364|OTHER|Difference between treatment groups|Difference in % (DOR/ISL- BIC/FTC/TAF)|-3.5|||||TWO_SIDED|95.0|-10.4|3.4|||||Based on Miettinen and Nurminen method|||3.4|-10.4|
72485813|NCT04223791|144499365|OTHER|Difference between treatment groups|Difference in % (DOR/ISL- BIC/FTC/TAF)|-0.02|||||TWO_SIDED|95.0|-2.7|2.6|||||Based on Miettinen and Nurminen method|||2.6|-2.7|
72485814|NCT04223791|144499378|SUPERIORITY||Treatment Difference|-0.3||||0.392|TWO_SIDED|95.0|-0.99|0.39|||ANCOVA|Model included terms for baseline weight, sex, race, and treatment.|Treatment difference for DOR/ISL group-BIC/FTC/TAF group.|||0.39|-0.99|0.392
72485815|NCT01372150|144499400|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.71||||0.226|TWO_SIDED|95.0|-1.06|4.48|||Mixed-effects model for repeated measure|Mixed-effects model for repeated measures (MMRM)|Adjusted mean difference = placebo - fluoxetine|Fluoxetine versus Placebo||4.48|-1.06|0.226
72485816|NCT01372150|144499400|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.47||||0.739|TWO_SIDED|95.0|-3.23|2.3|||MMRM||Adjusted mean difference = Placebo - DVS SR|DVS SR versus Placebo||2.30|-3.23|0.739
72485817|NCT01372150|144499401|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.18||||0.224|TWO_SIDED|95.0|-0.11|0.46|||MMRM||Adjusted mean difference = Placebo - Fluoxetine|Fluoxetine versus Placebo||0.46|-0.11|0.224
72485818|NCT01372150|144499401|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01||||0.944|TWO_SIDED|95.0|-0.29|0.27|||MMRM||Adjusted mean difference = Placebo - DVS SR|DVS SR versus Placebo||0.27|-0.29|0.944
72485819|NCT01372150|144499402|SUPERIORITY_OR_OTHER|||||||0.924||||||"P-value obtained from the Cochran-Mantel-Haenszel test for the alternative hypothesis of Row Mean Scores Differences."|Cochran-Mantel-Haenszel|||Fluoxetine versus Placebo - Week 1||||0.924
72485820|NCT01372150|144499402|SUPERIORITY_OR_OTHER|||||||0.698||||||"P-value obtained from the Cochran-Mantel-Haenszel test for the alternative hypothesis of Row Mean Scores Differences."|Cochran-Mantel-Haenszel|||DVS SR versus Placebo - Week 1||||0.698
72485821|NCT01372150|144499402|SUPERIORITY_OR_OTHER|||||||0.214||||||"P-value obtained from the Cochran-Mantel-Haenszel test for the alternative hypothesis of Row Mean Scores Differences."|Cochran-Mantel-Haenszel|||Fluoxetine versus Placebo - Week 2||||0.214
72485822|NCT01372150|144499402|SUPERIORITY_OR_OTHER|||||||0.113||||||"P-value obtained from the Cochran-Mantel-Haenszel test for the alternative hypothesis of Row Mean Scores Differences."|Cochran-Mantel-Haenszel|||DVS SR versus Placebo - Week 2||||0.113
72512885|NCT01683071|144556282|SUPERIORITY||LSMD|-94.3||||0.0386|TWO_SIDED|95.0|-184.0|-5.0|||ANCOVA|||||-5|-184|0.0386
72512886|NCT01683071|144556282|SUPERIORITY||LSMD|-96.5|||<|0.0001|TWO_SIDED|95.0|-144.0|-49.0|||ANCOVA|||||-49|-144|<0.0001
72485823|NCT01372150|144499402|SUPERIORITY_OR_OTHER|||||||0.314||||||"P-value obtained from the Cochran-Mantel-Haenszel test for the alternative hypothesis of Row Mean Scores Differences."|Cochran-Mantel-Haenszel|||Fluoxetine versus Placebo - Week 3||||0.314
72485824|NCT01372150|144499402|SUPERIORITY_OR_OTHER|||||||0.659||||||"P-value obtained from the Cochran-Mantel-Haenszel test for the alternative hypothesis of Row Mean Scores Differences."|Cochran-Mantel-Haenszel|||DVS SR versus Placebo - Week 3||||0.659
72485825|NCT01372150|144499402|SUPERIORITY_OR_OTHER|||||||0.577||||||"P-value obtained from the Cochran-Mantel-Haenszel test for the alternative hypothesis of Row Mean Scores Differences."|Cochran-Mantel-Haenszel|||Fluoxetine versus Placebo - Week 4||||0.577
72485826|NCT01372150|144499402|SUPERIORITY_OR_OTHER|||||||0.187||||||"P-value obtained from the Cochran-Mantel-Haenszel test for the alternative hypothesis of Row Mean Scores Differences."|Cochran-Mantel-Haenszel|||DVS SR versus Placebo - Week 4||||0.187
72485827|NCT01372150|144499402|SUPERIORITY_OR_OTHER|||||||0.051||||||"P-value obtained from the Cochran-Mantel-Haenszel test for the alternative hypothesis of Row Mean Scores Differences."|Cochran-Mantel-Haenszel|||Fluoxetine versus Placebo - Week 6||||0.051
72485828|NCT01372150|144499402|SUPERIORITY_OR_OTHER|||||||0.266||||||"P-value obtained from the Cochran-Mantel-Haenszel test for the alternative hypothesis of Row Mean Scores Differences."|Cochran-Mantel-Haenszel|||DVS SR versus Placebo - Week 6||||0.266
72485829|NCT01372150|144499402|SUPERIORITY_OR_OTHER|||||||0.095||||||"P-value obtained from the Cochran-Mantel-Haenszel test for the alternative hypothesis of Row Mean Scores Differences."|Cochran-Mantel-Haenszel|||Fluoxetine versus Placebo - Week 8||||0.095
72512887|NCT01683071|144556283|SUPERIORITY||Geometric LSM ratio|0.9||||0.6182|TWO_SIDED|95.0|0.6|1.3|||ANOVA|||||1.3|0.6|0.6182
72512888|NCT01683071|144556283|SUPERIORITY||Geometric LSM ratio|0.73||||0.1097|TWO_SIDED|95.0|0.5|1.1|||ANOVA|||||1.1|0.5|0.1097
72512889|NCT01683071|144556283|SUPERIORITY||Geometric LSM ratio|0.85||||0.4046|TWO_SIDED|95.0|0.6|1.3|||ANOVA|||||1.3|0.6|0.4046
72512890|NCT01683071|144556283|SUPERIORITY||Geometric LSM ratio|0.74||||0.0016|TWO_SIDED|95.0|0.6|0.9|||ANOVA|||||0.9|0.6|0.0016
72512891|NCT01968187|144556286|OTHER||LS Mean Difference|-6.7||||0.029|ONE_SIDED|90.0||-2.2|||ANCOVA|Treatment groups were compared using ANCOVA model with treatment and site as fixed effect and HPWSQ-R total score at baseline as covariate.||||-2.2||0.0290
72624107|NCT01892189|144778533|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1731|STANDARD_ERROR_OF_MEAN|0.18808||0.364|TWO_SIDED|95.0|-0.5553|0.2092|||ANOVA||Difference between least square means of TAK-063 3 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Right Posterior Cingulate Cortex: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.2092|-0.5553|0.364
72624108|NCT01892189|144778533|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1362|STANDARD_ERROR_OF_MEAN|0.20294||0.507|TWO_SIDED|95.0|-0.2762|0.5486|||ANOVA||Difference between least square means of TAK-063 10 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Right Posterior Cingulate Cortex: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.5486|-0.2762|0.507
72402697|NCT01480076|144311690|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 9, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 psychological score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
72485830|NCT01372150|144499402|SUPERIORITY_OR_OTHER|||||||0.852||||||"P-value obtained from the Cochran-Mantel-Haenszel test for the alternative hypothesis of Row Mean Scores Differences."|Cochran-Mantel-Haenszel|||DVS SR versus Placebo - Week 8||||0.852
72485831|NCT01372150|144499403|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.55||||0.186|TWO_SIDED|95.0|0.226|1.335|||Regression, Logistic||Logistic Regression using Response (Y/N) at each time point (excluding Week 9) as a response variable and treatment, age group and country as factors.|Fluoxetine versus Placebo - Week 1||1.335|0.226|0.186
72485832|NCT01372150|144499403|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.99||||0.984|TWO_SIDED|95.0|0.382|2.567|||Regression, Logistic||Logistic Regression using Response (Y/N) at each time point (excluding Week 9) as a response variable and treatment, age group and country as factors.|DVS SR versus Placebo - Week 1||2.567|0.382|0.984
72485833|NCT01372150|144499403|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.795||||0.462|TWO_SIDED|95.0|0.431|1.465|||Regression, Logistic||Logistic Regression using Response (Y/N) at each time point (excluding Week 9) as a response variable and treatment, age group and country as factors.|Fluoxetine versus Placebo - Week 2||1.465|0.431|0.462
72485834|NCT01372150|144499403|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.726||||0.297|TWO_SIDED|95.0|0.399|1.324|||Regression, Logistic||Logistic Regression using Response (Y/N) at each time point (excluding Week 9) as a response variable and treatment, age group and country as factors.|DVS SR versus Placebo - Week 2||1.324|0.399|0.297
72485835|NCT01372150|144499403|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.688||||0.194|TWO_SIDED|95.0|0.391|1.21|||Regression, Logistic||Logistic Regression using Response (Y/N) at each time point (excluding Week 9) as a response variable and treatment, age group and country as factors.|Fluoxetine versus Placebo - Week 3||1.210|0.391|0.194
72485836|NCT01372150|144499403|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.732||||0.272|TWO_SIDED|95.0|0.419|1.277|||Regression, Logistic||Logistic Regression using Response (Y/N) at each time point (excluding Week 9) as a response variable and treatment, age group and country as factors.|DVS SR versus Placebo - Week 3||1.277|0.419|0.272
72485837|NCT01372150|144499403|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.748||||0.313|TWO_SIDED|95.0|0.426|1.314|||Regression, Logistic||Logistic Regression using Response (Y/N) at each time point (excluding Week 9) as a response variable and treatment, age group and country as factors.|Flouxetine versus Placebo - Week 4||1.314|0.426|0.313
72485838|NCT01372150|144499403|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.663||||0.157|TWO_SIDED|95.0|0.376|1.171|||Regression, Logistic||Logistic Regression using Response (Y/N) at each time point (excluding Week 9) as a response variable and treatment, age group and country as factors.|DVS SR versus Placebo - Week 4||1.171|0.376|0.157
72485839|NCT01372150|144499403|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.579||||0.072|TWO_SIDED|95.0|0.319|1.05|||Regression, Logistic||Logistic Regression using Response (Y/N) at each time point (excluding Week 9) as a response variable and treatment, age group and country as factors.|Flouxetine versus Placebo - Week 6||1.050|0.319|0.072
72485840|NCT01372150|144499403|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.64||||0.135|TWO_SIDED|95.0|0.356|1.149|||Regression, Logistic||Logistic Regression using Response (Y/N) at each time point (excluding Week 9) as a response variable and treatment, age group and country as factors.|DVS SR versus Placebo - Week 6||1.149|0.356|0.135
72485841|NCT01372150|144499403|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.465||||0.017|TWO_SIDED|95.0|0.249|0.871|||Regression, Logistic||Logistic Regression using Response (Y/N) at each time point (excluding Week 9) as a response variable and treatment, age group and country as factors.|Flouxetine versus Placebo - Week 8||0.871|0.249|0.017
72485842|NCT01372150|144499403|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.751||||0.343|TWO_SIDED|95.0|0.415|1.357|||Regression, Logistic||Logistic Regression using Response (Y/N) at each time point (excluding Week 9) as a response variable and treatment, age group and country as factors.|DVS SR versus Placebo - Week 8||1.357|0.415|0.343
72485843|NCT05215262|144499406|SUPERIORITY||Mean Difference (Final Values)|1.87||||0.04|TWO_SIDED|95.0|0.04|3.17|||Mixed Models Analysis|||||3.17|0.04|0.04
72485844|NCT05215262|144499406|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.82|TWO_SIDED|95.0|-1.59|1.99|||Mixed Models Analysis|||||1.99|-1.59|0.82
72485845|NCT05215262|144499406|SUPERIORITY||Mean Difference (Final Values)|1.67||||0.2|TWO_SIDED|95.0|-0.89|4.23|||Mixed Models Analysis|||Difference-in-differences results, comparing GSES scores between the Intervention and Standard of Care groups at the three-month time point.||4.23|-0.89|0.20
72485846|NCT00718549|144499417|SUPERIORITY|||||||0.028|||||||Log Rank|||||||0.028
72485847|NCT00718549|144499417|SUPERIORITY||Hazard Ratio (HR)|0.418||||0.033||95.0|0.187|0.933|||Cox's proportional hazards regression|||Univariate comparison||0.933|0.187|0.033
72485848|NCT00718549|144499417|SUPERIORITY||Hazard Ratio (HR)|0.052||||0.111|TWO_SIDED|95.0|0.001|1.972|||Cox's proportional hazards model|||Multivariate Comparison||1.972|0.001|0.111
72485849|NCT00718549|144499418|SUPERIORITY||Odds Ratio (OR)|3.654||||0.155|TWO_SIDED|95.0|0.674|28.337|||Regression, Logistic|||Week 129: Univariate Comparison||28.337|0.674|0.155
72512892|NCT01968187|144556287|OTHER||LS Mean Difference|-0.8||||0.0233|ONE_SIDED|90.0||-0.3|||ANCOVA|Treatment groups were compared using ANCOVA model with treatment and site as fixed effects and CGI-S score as a covariate.||||-0.3||0.0233
72512893|NCT01968187|144556288|OTHER||LS Mean Difference|-2.0||||0.1172|ONE_SIDED|90.0||0.2|||ANCOVA|Treatment groups were compared using ANCOVA model with treatment and site as fixed effects and HPWSQ-R domain score at baseline as a covariate.||HPWSQ-R Domain score: Behavior||0.2||0.1172
72512894|NCT01968187|144556288|OTHER||LS Mean Difference|-1.6||||0.1436|ONE_SIDED|90.0||0.3|||ANCOVA|Treatment groups were compared using ANCOVA model with treatment and site as fixed effects and HPWSQ-R domain score -at baseline as a covariate.||HPWSQ-R Domain score: Drive||0.3||0.1436
72512895|NCT01968187|144556288|OTHER||LS Mean Difference|-1.5||||0.0248|ONE_SIDED|90.0||-0.5|||ANCOVA|Treatment groups were compared using ANCOVA model with treatment and site as fixed effects and HPWSQ-R domain score -at baseline as a covariate.||HPWSQ-R Domain score: Severity||-0.5||0.0248
72512896|NCT01968187|144556289|OTHER||LS mean difference|-6.2||||0.0047|ONE_SIDED|90.0||-3.3|||ANCOVA|From ANCOVA model with treatment and site as fixed effects and CY-BOCS total score at baseline as a covariate.||||-3.3||0.0047
72512897|NCT01968187|144556290|OTHER||LS mean difference|-4.4||||0.0132|ONE_SIDED|90.0||-1.9|||ANCOVA|Compared using ANCOVA model with treatment and site as fixed effects and Food Domain Score of Reiss Profile at baseline as a covariate.||||-1.9||0.0132
72402698|NCT01480076|144311690|SUPERIORITY_OR_OTHER|||||||0.5655|||||||mixed effect model|||Month 9, Non-responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 psychological score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.5655
72512898|NCT04095286|144556291|OTHER||Ratio of adjusted geometric mean|1.03|||||TWO_SIDED|90.0|0.96|1.11|||||Treatment comparison between AMB dispersed in water and reference AMB tablet using ratio of adjusted geometric mean and its corresponding 90% confidence interval has been presented|||1.11|0.96|
72512899|NCT04095286|144556291|OTHER||Ratio of adjusted geometric mean|0.91|||||TWO_SIDED|90.0|0.85|0.98|||||Treatment comparison between AMB oral tablet and reference AMB tablet using ratio of adjusted geometric mean and its corresponding 90% confidence interval has been presented|||0.98|0.85|
72512900|NCT04095286|144556294|OTHER||Ratio of adjusted geometric mean|1.05|||||TWO_SIDED|90.0|1.02|1.09|||||Treatment comparison between AMB dispersed in water and reference AMB tablet using ratio of adjusted geometric mean and its corresponding 90% confidence interval has been presented|||1.09|1.02|
72512901|NCT04095286|144556294|OTHER||Ratio of adjusted geometric mean|1.04|||||TWO_SIDED|90.0|1.0|1.08|||||Treatment comparison between AMB oral tablet and reference AMB tablet using ratio of adjusted geometric mean and its corresponding 90% confidence interval has been presented|||1.08|1.00|
72512902|NCT04095286|144556295|OTHER||Ratio of adjusted geometric mean|1.05|||||TWO_SIDED|90.0|1.02|1.08|||||Treatment comparison between AMB dispersed in water and reference AMB tablet using ratio of adjusted geometric mean and its corresponding 90% confidence interval has been presented|||1.08|1.02|
72512903|NCT04095286|144556295|OTHER||Ratio of adjusted geometric mean|1.04|||||TWO_SIDED|90.0|1.01|1.07|||||Treatment comparison between AMB oral tablet and reference AMB tablet using ratio of adjusted geometric mean and its corresponding 90% confidence interval has been presented|||1.07|1.01|
72512904|NCT02020031|144556303|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||Comparison at approximately 3 minutes, adjusted by BMI, age, and length of surgical procedure.||||<0.0001
72512905|NCT02020031|144556303|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||Comparison at approximately 30 minutes, adjusted by BMI, age, and length of surgical procedure.||||<0.0001
72512906|NCT02020031|144556303|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||Comparison at approximately 50 minutes, adjusted by BMI, age, and length of surgical procedure.||||<0.0001
72512907|NCT02020031|144556303|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||Comparison at approximately 115 minutes, adjusted by BMI, age, and length of surgical procedure.||||<0.0001
72512908|NCT02020031|144556303|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||Comparison at approximately 150 minutes, adjusted by BMI, age, and length of surgical procedure.||||<0.0001
72512909|NCT02020031|144556303|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||Comparison at approximately 180 minutes, adjusted by BMI, age, and length of surgical procedure.||||<0.0001
72512910|NCT04047121|144556305|SUPERIORITY|||||||0.2531|||||||Chi-squared|||||||0.2531
72512911|NCT04047121|144556305|SUPERIORITY|||||||0.0295|||||||Chi-squared|||||||0.0295
72512912|NCT04047121|144556305|SUPERIORITY|||||||0.1857|||||||Chi-squared|||||||0.1857
72512913|NCT04047121|144556305|SUPERIORITY||Odds Ratio (OR)|0.8401||||0.3297|TWO_SIDED|95.0|0.5919|1.1925|||Regression, Logistic|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement.) on the outcome measure, multivariable analysis was performed.||1.1925|0.5919|0.3297
72512914|NCT04047121|144556305|SUPERIORITY||Odds Ratio (OR)|1.5066||||0.2003|TWO_SIDED|95.0|0.8046|2.8209|||Regression, Logistic|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement.) on the outcome measure, multivariable analysis was performed.||2.8209|0.8046|0.2003
72512915|NCT04047121|144556305|SUPERIORITY||Odds Ratio (OR)|1.4052||||0.2276|TWO_SIDED|95.0|0.8086|2.442|||Regression, Logistic|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement.) on the outcome measure, multivariable analysis was performed.||2.4420|0.8086|0.2276
72512916|NCT04047121|144556306|SUPERIORITY|||||||0.8786|||||||Chi-squared|||||||0.8786
72512917|NCT04047121|144556306|SUPERIORITY|||||||0.1178|||||||Chi-squared|||||||0.1178
72512918|NCT04047121|144556306|SUPERIORITY|||||||0.5337|||||||Chi-squared|||||||0.5337
72512919|NCT04047121|144556306|SUPERIORITY||Odds Ratio (OR)|1.0283||||0.9212|TWO_SIDED|95.0|0.5911|1.789|||Regression, Logistic|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement.) on the outcome measure, multivariable analysis was performed.||1.7890|0.5911|0.9212
72402699|NCT01480076|144311690|SUPERIORITY_OR_OTHER||difference of LS means|-5.9|STANDARD_ERROR_OF_MEAN|2.54||0.0204|TWO_SIDED||||||mixed effect model|||Month 9, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 psychological score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0204
72485850|NCT00718549|144499419|SUPERIORITY||Odds Ratio (OR)|0.625||||0.634|TWO_SIDED|95.0|0.073|4.114|||Regression, Logistic|||Week 129: Univariate comparison||4.114|0.073|0.634
72485851|NCT00718549|144499420|SUPERIORITY||Hazard Ratio (HR)|0.769||||0.752|TWO_SIDED|95.0|0.151|3.92|||Cox's proportional hazards model|||Multivariate Comparison: Age \<60 years versus Age \>/=60 years||3.920|0.151|0.752
72485852|NCT00718549|144499420|SUPERIORITY||Hazard Ratio (HR)|0.068||||0.128|TWO_SIDED|95.0|0.002|2.158|||Cox's proportional hazards model|||Multivariate Comparison: Sex: Female versus Male||2.158|0.002|0.128
72485853|NCT00718549|144499420|SUPERIORITY||Hazard Ratio (HR)|2.282||||0.728|TWO_SIDED|95.0|0.022|240.864|||Cox's proportional hazards model|||Multivariate Comparison: Rai Stage: I or II versus Rai Stage: III or IV||240.864|0.022|0.728
72485854|NCT00718549|144499420|SUPERIORITY||Hazard Ratio (HR)|26.275||||0.048|TWO_SIDED|95.0|1.036|666.708|||Cox's proportional hazards model|||Multivariate Comparison: Beta-2-Microglobulin \>/= Median Value versus Beta-2-Microglobulin \<Median Value||666.708|1.036|0.048
72485855|NCT00718549|144499420|SUPERIORITY||Hazard Ratio (HR)|0.21||||0.417|TWO_SIDED|95.0|0.005|9.1|||Cox's proportional hazards model|||Multivariate Comparison: ZAP-70 Expression Negative versus Positive||9.100|0.005|0.417
72485856|NCT00718549|144499420|SUPERIORITY||Hazard Ratio (HR)|0.197||||0.134|TWO_SIDED|95.0|0.024|1.647|||Cox's proportional hazards model|||Multivariate Comparison: CD38 Expression Negative versus Positive||1.647|0.024|0.134
72485857|NCT00718549|144499420|SUPERIORITY||Hazard Ratio (HR)|8.373||||0.426|TWO_SIDED|95.0|0.045|1568.717|||Cox's proportional hazards model|||Multivariate Comparison: Cytogenetic abnormality 17p No versus Yes||1568.717|0.045|0.426
72485858|NCT00718549|144499420|SUPERIORITY||Hazard Ratio (HR)|0.438||||0.733|TWO_SIDED|95.0|0.004|50.334|||Cox's proportional hazards model|||Multivariate Comparison: Cytogenetic abnormality 13q No versus Yes||50.334|0.004|0.733
72485859|NCT00718549|144499420|SUPERIORITY||Hazard Ratio (HR)|2.621||||0.463|TWO_SIDED|95.0|0.2|34.422|||Cox's proportional hazards model|||Multivariate Comparison: Cytogenetic abnormality 11q No versus Yes||34.422|0.200|0.463
72485860|NCT00718549|144499420|SUPERIORITY||Hazard Ratio (HR)|0.288||||0.397|TWO_SIDED|95.0|0.016|5.122|||Cox's proportional hazards model|||Multivariate Comparison: Cytogenetic abnormality 12q No versus Yes||5.122|0.016|0.397
72485861|NCT00718549|144499421|SUPERIORITY||Odds Ratio (OR)|0.982||||0.969|TWO_SIDED|95.0|0.393|2.531|||Regression, Logistic|||Univariate Comparison: Age \<60 years versus Age \>/=60 years||2.531|0.393|0.969
72512920|NCT04047121|144556306|SUPERIORITY||Odds Ratio (OR)|0.7464||||0.4693|TWO_SIDED|95.0|0.338|1.6482|||Regression, Logistic|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement.) on the outcome measure, multivariable analysis was performed.||1.6482|0.3380|0.4693
72512921|NCT04047121|144556306|SUPERIORITY||Odds Ratio (OR)|0.8212||||0.5593|TWO_SIDED|95.0|0.4239|1.591|||Regression, Logistic|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement.) on the outcome measure, multivariable analysis was performed.||1.5910|0.4239|0.5593
72512922|NCT04047121|144556307|SUPERIORITY|||||||0.6205|||||||Chi-squared|||||||0.6205
72485862|NCT00718549|144499421|SUPERIORITY||Odds Ratio (OR)|0.552||||0.26|TWO_SIDED|95.0|0.183|1.488|||Regression, Logistic|||Univariate Comparison: Sex: Female versus Male||1.488|0.183|0.260
72485863|NCT00718549|144499421|SUPERIORITY||Odds Ratio (OR)|0.465||||0.121|TWO_SIDED|95.0|0.177|1.242|||Regression, Logistic|||Univariate Comparison: Rai Stage: I or II versus Rai Stage: III or IV||1.242|0.177|0.121
72485864|NCT00718549|144499421|SUPERIORITY||Odds Ratio (OR)|0.374||||0.045|TWO_SIDED|95.0|0.137|0.957|||Regression, Logistic|||Univariate Comparison: Beta-2-Microglobulin \>/= Median Value versus Beta-2-Microglobulin \<Median Value||0.957|0.137|0.045
72485865|NCT00718549|144499421|SUPERIORITY||Odds Ratio (OR)|8.809||||0.04|TWO_SIDED|95.0|1.655|163.316|||Regression, Logistic|||Univariate Comparison: ZAP-70 Expression Negative versus Positive||163.316|1.655|0.040
72485866|NCT00718549|144499421|SUPERIORITY||Odds Ratio (OR)|0.921||||0.887|TWO_SIDED|95.0|0.287|2.851|||Regression, Logistic|||Univariate Comparison: CD38 Expression Negative versus Positive||2.851|0.287|0.887
72485867|NCT00718549|144499421|SUPERIORITY||Odds Ratio (OR)|0.932||||0.936|TWO_SIDED|95.0|0.186|6.839|||Regression, Logistic|||Univariate Comparison: Cytogenetic abnormality 17p No versus Yes||6.839|0.186|0.936
72485868|NCT00718549|144499421|SUPERIORITY||Odds Ratio (OR)|1.88||||0.199|TWO_SIDED|95.0|0.719|5.012|||Regression, Logistic|||Univariate Comparison: Cytogenetic abnormality 13q No versus Yes||5.012|0.719|0.199
72485869|NCT00718549|144499421|SUPERIORITY||Odds Ratio (OR)|1.668||||0.375|TWO_SIDED|95.0|0.566|5.649|||Regression, Logistic|||Univariate Comparison: Cytogenetic abnormality 11q No versus Yes||5.649|0.566|0.375
72485870|NCT00718549|144499421|SUPERIORITY||Odds Ratio (OR)|0.957||||0.961|TWO_SIDED|95.0|0.173|7.275|||Regression, Logistic|||Univariate Comparison: Cytogenetic abnormality 12q No versus Yes||7.275|0.173|0.961
72485871|NCT00718549|144499422|SUPERIORITY||Odds Ratio (OR)|1.31||||0.768|TWO_SIDED|95.0|0.237|10.189|||Regression, Logistic|||Univariate Comparison: Age \<60 years versus Age \>/=60 years||10.189|0.237|0.768
72485872|NCT00718549|144499422|SUPERIORITY||Odds Ratio (OR)|0.667||||0.657|TWO_SIDED|95.0|0.086|3.653|||Regression, Logistic|||Univariate Comparison: Sex: Female versus Male||3.653|0.086|0.657
72485873|NCT00718549|144499422|SUPERIORITY||Odds Ratio (OR)|1.68||||0.655|TWO_SIDED|95.0|0.229|34.486|||Regression, Logistic|||Univariate Comparison: Rai Stage: I or II versus Rai Stage: III or IV||34.486|0.229|0.655
72485874|NCT00718549|144499422|SUPERIORITY||Odds Ratio (OR)|0.635||||0.595|TWO_SIDED|95.0|0.117|3.73|||Regression, Logistic|||Univariate Comparison: Beta-2-Microglobulin \>/= Median Value versus Beta-2-Microglobulin \<Median Value||3.730|0.117|0.595
72512923|NCT04047121|144556307|SUPERIORITY|||||||0.4924|||||||Chi-squared|||||||0.4924
72512924|NCT04047121|144556307|SUPERIORITY|||||||0.4982|||||||Chi-squared|||||||0.4982
72512925|NCT04047121|144556307|SUPERIORITY||Odds Ratio (OR)|1.3182||||0.5494|TWO_SIDED|95.0|0.5335|3.257|||Regression, Logistic|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement.) on the outcome measure, multivariable analysis was performed.||3.2570|0.5335|0.5494
72512926|NCT04047121|144556307|SUPERIORITY||Odds Ratio (OR)|1.1664||||0.783|TWO_SIDED|95.0|0.39|3.4883|||Regression, Logistic|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement.) on the outcome measure, multivariable analysis was performed.||3.4883|0.3900|0.7830
72512927|NCT04047121|144556308|SUPERIORITY|||||||0.3817|||||||Chi-squared|||||||0.3817
72512928|NCT04047121|144556308|SUPERIORITY|||||||0.7397|||||||Chi-squared|||||||0.7397
72512929|NCT04047121|144556308|SUPERIORITY|||||||0.7942|||||||Chi-squared|||||||0.7942
72512930|NCT04047121|144556308|SUPERIORITY||Odds Ratio (OR)|1.0682||||0.7924|TWO_SIDED|95.0|0.6537|1.7455|||Regression, Logistic|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement.) on the outcome measure, multivariable analysis was performed.||1.7455|0.6537|0.7924
72512931|NCT04047121|144556308|SUPERIORITY||Odds Ratio (OR)|1.0414||||0.9339|TWO_SIDED|95.0|0.3997|2.7134|||Regression, Logistic|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement.) on the outcome measure, multivariable analysis was performed.||2.7134|0.3997|0.9339
72512932|NCT04047121|144556308|SUPERIORITY||Odds Ratio (OR)|0.8195||||0.6497|TWO_SIDED|95.0|0.347|1.935|||Regression, Logistic|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement.) on the outcome measure, multivariable analysis was performed.||1.9350|0.3470|0.6497
72512933|NCT04047121|144556309|SUPERIORITY|||||||0.7936|||||||Chi-squared|||||||0.7936
72624109|NCT01892189|144778533|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2464|STANDARD_ERROR_OF_MEAN|0.19276||0.21|TWO_SIDED|95.0|-0.6381|0.1453|||ANOVA||Difference between least square means of TAK-063 30 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Right Posterior Cingulate Cortex: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.1453|-0.6381|0.210
72512934|NCT04047121|144556309|SUPERIORITY|||||||0.5621|||||||Chi-squared|||||||0.5621
72512935|NCT04047121|144556309|SUPERIORITY|||||||0.68|||||||Chi-squared|||||||0.6800
72512936|NCT04047121|144556309|SUPERIORITY||Odds Ratio (OR)|1.1438||||0.5051|TWO_SIDED|95.0|0.7705|1.6978|||Regression, Logistic|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement.) on the outcome measure, multivariable analysis was performed.||1.6978|0.7705|0.5051
72512937|NCT04047121|144556309|SUPERIORITY||Odds Ratio (OR)|0.8576||||0.7131|TWO_SIDED|95.0|0.3781|1.9452|||Regression, Logistic|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement.) on the outcome measure, multivariable analysis was performed.||1.9452|0.3781|0.7131
72512938|NCT04047121|144556309|SUPERIORITY||Odds Ratio (OR)|0.8415||||0.649|TWO_SIDED|95.0|0.4003|1.769|||Regression, Logistic|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement.) on the outcome measure, multivariable analysis was performed.||1.7690|0.4003|0.6490
72512939|NCT04047121|144556310|SUPERIORITY|||||||0.5217|||||||Chi-squared|||||||0.5217
72512940|NCT04047121|144556310|SUPERIORITY|||||||0.0432|||||||Chi-squared|||||||0.0432
72512941|NCT04047121|144556310|SUPERIORITY|||||||0.2573|||||||Chi-squared|||||||0.2573
72512942|NCT04047121|144556310|SUPERIORITY||Odds Ratio (OR)|1.1637||||0.5368|TWO_SIDED|95.0|0.7193|1.8827|||Regression, Logistic|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement.) on the outcome measure, multivariable analysis was performed.||1.8827|0.7193|0.5368
72512943|NCT04047121|144556310|SUPERIORITY||Odds Ratio (OR)|0.7757||||0.4685|TWO_SIDED|95.0|0.3904|1.5413|||Regression, Logistic|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement.) on the outcome measure, multivariable analysis was performed.||1.5413|0.3904|0.4685
72512944|NCT04047121|144556310|SUPERIORITY||Odds Ratio (OR)|0.7354||||0.3112|TWO_SIDED|95.0|0.4057|1.333|||Regression, Logistic|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement.) on the outcome measure, multivariable analysis was performed.||1.3330|0.4057|0.3112
72512945|NCT04047121|144556311|SUPERIORITY|||||||0.8122|||||||Log Rank|||||||0.8122
72512946|NCT04047121|144556311|SUPERIORITY|||||||0.7766|||||||Log Rank|||||||0.7766
72512947|NCT04047121|144556311|SUPERIORITY|||||||0.8305|||||||Log Rank|||||||0.8305
72512948|NCT04047121|144556311|SUPERIORITY||Hazard Ratio (HR)|0.5814||||0.1845|TWO_SIDED|95.0|0.261|1.2952|||Regression, Cox|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement.) on the outcome measure, multivariable analysis was performed.||1.2952|0.2610|0.1845
72512949|NCT04047121|144556311|SUPERIORITY||Hazard Ratio (HR)|1.5908||||0.2951|TWO_SIDED|95.0|0.6671|3.7936|||Regression, Cox|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement.) on the outcome measure, multivariable analysis was performed.||3.7936|0.6671|0.2951
72512950|NCT04047121|144556311|SUPERIORITY||Hazard Ratio (HR)|1.3546||||0.4907|TWO_SIDED|95.0|0.6584|2.787|||Regression, Cox|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement.) on the outcome measure, multivariable analysis was performed.||2.7870|0.6584|0.4907
72512951|NCT04047121|144556312|SUPERIORITY|||||||0.6006|||||||Log Rank|||||||0.6006
72512952|NCT04047121|144556312|SUPERIORITY|||||||0.2941|||||||Log Rank|||||||0.2941
72512953|NCT04047121|144556312|SUPERIORITY|||||||0.961|||||||Log Rank|||||||0.9610
72624110|NCT01892189|144778533|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3059|STANDARD_ERROR_OF_MEAN|0.14253||0.039|TWO_SIDED|95.0|-0.5955|-0.0162|||ANOVA||Difference between least square means of TAK-063 3 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Left Striatum: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||-0.0162|-0.5955|0.039
72485875|NCT00718549|144499422|SUPERIORITY||Odds Ratio (OR)|1.0||||1|TWO_SIDED|95.0|0.164|8.102|||Regression, Logistic|||Univariate Comparison: ZAP-70 Expression Negative versus Positive||8.102|0.164|1.000
72485876|NCT00718549|144499422|SUPERIORITY||Odds Ratio (OR)|0.857||||0.882|TWO_SIDED|95.0|0.093|6.636|||Regression, Logistic|||Univariate Comparison: CD38 Expression Negative versus Positive||6.636|0.093|0.882
72485877|NCT00718549|144499422|SUPERIORITY||Odds Ratio (OR)|0.154||||0.216|TWO_SIDED|95.0|0.005|4.405|||Regression, Logistic|||Univariate Comparison: Cytogenetic abnormality 17p No versus Yes||4.405|0.005|0.216
72485878|NCT00718549|144499422|SUPERIORITY||Odds Ratio (OR)|0.361||||0.396|TWO_SIDED|95.0|0.017|2.971|||Regression, Logistic|||Univariate Comparison: Cytogenetic abnormality 13q No versus Yes||2.971|0.017|0.396
72512954|NCT04047121|144556312|SUPERIORITY||Hazard Ratio (HR)|0.5571||||0.0455|TWO_SIDED|95.0|0.314|0.9884|||Regression, Cox|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement.) on the outcome measure, multivariable analysis was performed.||0.9884|0.3140|0.0455
72512955|NCT04047121|144556312|SUPERIORITY||Hazard Ratio (HR)|2.1781||||0.0274|TWO_SIDED|95.0|1.0904|4.3506|||Regression, Cox|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement.) on the outcome measure, multivariable analysis was performed.||4.3506|1.0904|0.0274
72512956|NCT04047121|144556312|SUPERIORITY||Hazard Ratio (HR)|0.8896||||0.6787|TWO_SIDED|95.0|0.5114|1.5475|||Regression, Cox|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement.) on the outcome measure, multivariable analysis was performed.||1.5475|0.5114|0.6787
72512957|NCT04047121|144556313|SUPERIORITY|||||||0.9084|||||||Log Rank|||||||0.9084
72512958|NCT04047121|144556313|SUPERIORITY|||||||0.8325|||||||Log Rank|||||||0.8325
72512959|NCT04047121|144556313|SUPERIORITY|||||||0.963|||||||Log Rank|||||||0.9630
72512960|NCT04047121|144556313|SUPERIORITY||Hazard Ratio (HR)|1.0508||||0.7909|TWO_SIDED|95.0|0.7284|1.516|||Regression, Cox|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement.) on the outcome measure, multivariable analysis was performed.||1.5160|0.7284|0.7909
72485879|NCT00718549|144499422|SUPERIORITY||Odds Ratio (OR)|0.75||||0.776|TWO_SIDED|95.0|0.103|6.572|||Regression, Logistic|||Univariate Comparison: Cytogenetic abnormality 11q No versus Yes||6.572|0.103|0.776
72485880|NCT00718549|144499423|SUPERIORITY||Odds Ratio (OR)|0.528||||0.357|TWO_SIDED|95.0|0.131|2.114|||Regression, Logistic|||Univariate Comparison: Age \<60 years versus Age \>/=60 years||2.114|0.131|0.357
72485881|NCT00718549|144499423|SUPERIORITY||Odds Ratio (OR)|0.694||||0.623|TWO_SIDED|95.0|0.138|2.8|||Regression, Logistic|||Univariate Comparison: Sex: Female versus Male||2.800|0.138|0.623
72485882|NCT00718549|144499423|SUPERIORITY||Odds Ratio (OR)|4.0||||0.097|TWO_SIDED|95.0|0.901|28.158|||Regression, Logistic|||Univariate Comparison: Beta-2-Microglobulin \>/= Median Value versus Beta-2-Microglobulin \<Median Value||28.158|0.901|0.097
72485883|NCT00718549|144499423|SUPERIORITY||Odds Ratio (OR)|4.2||||0.233|TWO_SIDED|95.0|0.484|89.588|||Regression, Logistic|||Univariate Comparison: CD38 Expression Negative versus Positive||89.588|0.484|0.233
72485884|NCT00718549|144499423|SUPERIORITY||Odds Ratio (OR)|0.844||||0.826|TWO_SIDED|95.0|0.161|3.681|||Regression, Logistic|||Univariate Comparison: Cytogenetic abnormality 13q No versus Yes||3.681|0.161|0.826
72485885|NCT00718549|144499423|SUPERIORITY||Odds Ratio (OR)|1.067||||0.933|TWO_SIDED|95.0|0.246|5.581|||Regression, Logistic|||Univariate Comparison: Cytogenetic abnormality 11q No versus Yes||5.581|0.246|0.933
72485886|NCT00718549|144499423|SUPERIORITY||Odds Ratio (OR)|0.727||||0.794|TWO_SIDED|95.0|0.08|15.779|||Regression, Logistic|||Univariate Comparison: Cytogenetic abnormality 12q No versus Yes||15.779|0.080|0.794
72485887|NCT00718549|144499424|SUPERIORITY||Odds Ratio (OR)|1.923||||0.591|TWO_SIDED|95.0|0.225|41.751|||Regression, Logistic|||Univariate Comparison: Age \<60 years versus Age \>/=60 years||41.751|0.225|0.591
72485888|NCT00718549|144499424|SUPERIORITY||Odds Ratio (OR)|1.3||||0.796|TWO_SIDED|95.0|0.147|9.222|||Regression, Logistic|||Univariate Comparison: Sex: Female versus Male||9.222|0.147|0.796
72485889|NCT00718549|144499424|SUPERIORITY||Odds Ratio (OR)|3.2||||0.338|TWO_SIDED|95.0|0.375|69.479|||Regression, Logistic|||Univariate Comparison: Beta-2-Microglobulin \>/= Median Value versus Beta-2-Microglobulin \<Median Value||69.479|0.375|0.338
72485890|NCT00718549|144499424|SUPERIORITY||Odds Ratio (OR)|2.333||||0.486|TWO_SIDED|95.0|0.201|29.008|||Regression, Logistic|||Univariate Comparison: CD38 Expression Negative versus Positive||29.008|0.201|0.486
72485891|NCT00718549|144499424|SUPERIORITY||Odds Ratio (OR)|0.667||||0.691|TWO_SIDED|95.0|0.074|4.722|||Regression, Logistic|||Univariate Comparison: Cytogenetic abnormality 13q No versus Yes||4.722|0.074|0.691
72485892|NCT00718549|144499424|SUPERIORITY||Odds Ratio (OR)|1.5||||0.691|TWO_SIDED|95.0|0.212|13.563|||Regression, Logistic|||Univariate Comparison: Cytogenetic abnormality 11q No versus Yes||13.563|0.212|0.691
72485893|NCT00718549|144499424|SUPERIORITY||Odds Ratio (OR)|1.0||||1|TWO_SIDED|95.0|0.076|24.621|||Regression, Logistic|||Univariate Comparison: Cytogenetic abnormality 12q No versus Yes||24.621|0.076|1.000
72485894|NCT00718549|144499424|SUPERIORITY||Odds Ratio (OR)|1.0||||1|TWO_SIDED|95.0|0.099|22.791|||Regression, Logistic|||Univariate Comparison: Rai Stage: I or II versus Rai Stage: III or IV||22.791|0.099|1.000
72512961|NCT04047121|144556313|SUPERIORITY||Hazard Ratio (HR)|0.8117||||0.6027|TWO_SIDED|95.0|0.37|1.7808|||Regression, Cox|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement.) on the outcome measure, multivariable analysis was performed.||1.7808|0.3700|0.6027
72567715|NCT00076804|144666978|SUPERIORITY_OR_OTHER|||||||0.42||||||Logistic regression analysis \& Cox proportional hazards regression analyses were performed to compare outcomes after adjusting for the relevant covariates,including study arm, age, sex, baseline CD4 cell counts and viral load and pill count adherence|Chi-squared|one degree of freedom||Unadjusted endpoint analyses were conducted on an intention-to-treat basis using all patients enrolled to compare outcomes in the DOT vs. Self-ART arm. For viral load analyses, missing values were considered detectable (missing¼failure analysis). As-treated analyses were also conducted using patients remaining in the study with available data.Crosssectional comparisons between study groups were conducted using two sample t-test,Wilcoxon rank-sum test,chi-squared orFisher's exact and Kaplan-Meier||||0.42
72576922|NCT00261443|144680716|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.04||||0.945|TWO_SIDED|95.0|-1.21|1.12||ANOVA model, controlling for treatment and mood stabilizer, is used for baseline. ANCOVA model, controlling for treatment, mood stabilizer, and baseline value, is used for mean change from baseline.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences and p-values are based on the ANOVA/ANCOVA model.||Highest Value Treatment Difference||1.12|-1.21|0.945
72512962|NCT04047121|144556313|SUPERIORITY||Hazard Ratio (HR)|1.1742||||0.6978|TWO_SIDED|95.0|0.5222|2.6404|||Regression, Cox|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement.) on the outcome measure, multivariable analysis was performed.||2.6404|0.5222|0.6978
72512963|NCT04047121|144556314|SUPERIORITY|||||||0.1736|||||||Log Rank|||||||0.1736
72512964|NCT04047121|144556314|SUPERIORITY|||||||0.0195|||||||Log Rank|||||||0.0195
72512965|NCT04047121|144556314|SUPERIORITY|||||||0.2104|||||||Log Rank|||||||0.2104
72512966|NCT04047121|144556314|SUPERIORITY||Hazard Ratio (HR)|1.1723||||0.167|TWO_SIDED|95.0|0.9357|1.4687|||Regression, Cox|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement.) on the outcome measure, multivariable analysis was performed.||1.4687|0.9357|0.1670
72512967|NCT04047121|144556314|SUPERIORITY||Hazard Ratio (HR)|0.7228||||0.1087|TWO_SIDED|95.0|0.4861|1.0747|||Regression, Cox|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement.) on the outcome measure, multivariable analysis was performed.||1.0747|0.4861|0.1087
72512968|NCT04047121|144556314|SUPERIORITY||Hazard Ratio (HR)|0.8402||||0.3212|TWO_SIDED|95.0|0.5957|1.1852|||Regression, Cox|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement.) on the outcome measure, multivariable analysis was performed.||1.1852|0.5957|0.3212
72512969|NCT04047121|144556315|SUPERIORITY|||||||0.9361|||||||Chi-squared|||||||0.9361
72512970|NCT04047121|144556315|SUPERIORITY|||||||0.3851|||||||Chi-squared|||||||0.3851
72512971|NCT04047121|144556315|SUPERIORITY|||||||0.599|||||||Chi-squared|||||||0.5990
72512972|NCT04047121|144556315|SUPERIORITY||Odds Ratio (OR)|0.9954||||0.986|TWO_SIDED|95.0|0.5962|1.662|||Regression, Logistic|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement.) on the outcome measure, multivariable analysis was performed.||1.6620|0.5962|0.9860
72512973|NCT04047121|144556315|SUPERIORITY||Odds Ratio (OR)|1.2959||||0.5813|TWO_SIDED|95.0|0.5158|3.2558|||Regression, Logistic|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement.) on the outcome measure, multivariable analysis was performed.||3.2558|0.5158|0.5813
72512974|NCT04047121|144556315|SUPERIORITY||Odds Ratio (OR)|1.8182||||0.1789|TWO_SIDED|95.0|0.7604|4.3473|||Regression, Logistic|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||4.3473|0.7604|0.1789
72512975|NCT04047121|144556316|SUPERIORITY|||||||0.4009|||||||Chi-squared|||||||0.4009
72512976|NCT04047121|144556316|SUPERIORITY|||||||0.9765|||||||Chi-squared|||||||0.9765
72512977|NCT04047121|144556316|SUPERIORITY|||||||0.2849|||||||Chi-squared|||||||0.2849
72512978|NCT04047121|144556316|SUPERIORITY||Odds Ratio (OR)|0.8252||||0.5289|TWO_SIDED|95.0|0.4538|1.5007|||Regression, Logistic|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||1.5007|0.4538|0.5289
72512979|NCT04047121|144556316|SUPERIORITY||Odds Ratio (OR)|0.9408||||0.927|TWO_SIDED|95.0|0.2553|3.4678|||Regression, Logistic|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||3.4678|0.2553|0.9270
72512980|NCT04047121|144556316|SUPERIORITY||Odds Ratio (OR)|0.3968||||0.0707|TWO_SIDED|95.0|0.1456|1.0812|||Regression, Logistic|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||1.0812|0.1456|0.0707
72512981|NCT04047121|144556317|SUPERIORITY|||||||0.2061|||||||Chi-squared|||||||0.2061
72512982|NCT04047121|144556317|SUPERIORITY|||||||0.1908|||||||Chi-squared|||||||0.1908
72512983|NCT04047121|144556318|SUPERIORITY|||||||0.8033|||||||Chi-squared|||||||0.8033
72512984|NCT04047121|144556318|SUPERIORITY|||||||0.6669|||||||Chi-squared|||||||0.6669
72512985|NCT04047121|144556318|SUPERIORITY|||||||0.6477|||||||Chi-squared|||||||0.6477
72512986|NCT04047121|144556318|SUPERIORITY||Odds Ratio (OR)|0.7948||||0.5509|TWO_SIDED|95.0|0.3736|1.6907|||Regression, Logistic|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||1.6907|0.3736|0.5509
72512987|NCT04047121|144556318|SUPERIORITY||Odds Ratio (OR)|0.6814||||0.6216|TWO_SIDED|95.0|0.1486|3.125|||Regression, Logistic|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||3.1250|0.1486|0.6216
72512988|NCT04047121|144556318|SUPERIORITY||Odds Ratio (OR)|0.6974||||0.5506|TWO_SIDED|95.0|0.2135|2.2781|||Regression, Logistic|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||2.2781|0.2135|0.5506
72512989|NCT04047121|144556319|SUPERIORITY|||||||0.103|||||||Chi-squared|||||||0.1030
72485895|NCT03496324|144499444|EQUIVALENCE|Bioequivalence was demonstrated between NfC® and Algifor® Junior if each 90% confidence interval (CI) (rounded to 2 decimal places) for the ratio between least square geometric means (test / reference) lay within 80% and 125% for Cmax.|Geometric Least Square Mean|94.19|STANDARD_ERROR_OF_MEAN|18.9|||TWO_SIDED|90.0|85.81|103.38||||||||103.38|85.81|
72512990|NCT04047121|144556319|SUPERIORITY|||||||0.9317|||||||Chi-squared|||||||0.9317
72485896|NCT03496324|144499444|EQUIVALENCE|Bioequivalence was demonstrated between NfC® and Algifor® Junior if each 90% CI (rounded to 2 decimal places) for the ratio between least square geometric means (test / reference) lay within 80% and 125% for Cmax.|Geometric Least Square Mean|111.66|STANDARD_ERROR_OF_MEAN|14.3|||TWO_SIDED|90.0|103.84|120.07||||||||120.07|103.84|
72485897|NCT03496324|144499445|EQUIVALENCE|Bioequivalence was demonstrated between NfC® and Algifor® Junior if each 90% CI (rounded to 2 decimal places) for the ratio between least square geometric means (test / reference) lay within 80% and 125% for AUC0-t.|Geometric Least Square Mean|101.57|STANDARD_ERROR_OF_MEAN|10.5|||TWO_SIDED|90.0|96.28|107.16||||||||107.16|96.28|
72485898|NCT03496324|144499445|EQUIVALENCE|Bioequivalence was demonstrated between NfC® and Algifor® Junior if each 90% CI (rounded to 2 decimal places) for the ratio between least square geometric means (test / reference) lay within 80% and 125% for AUC0-t.|Geometric Least Square Mean|104.47|STANDARD_ERROR_OF_MEAN|6.0|||TWO_SIDED|90.0|101.4|107.63||||||||107.63|101.4|
72485899|NCT02092350|144499452|SUPERIORITY_OR_OTHER|||||||0.001|||||||One-sided exact test|||The primary hypothesis was that the SVR12 rate in the Immediate Treatment plus Intensive PK arm would be \>45%.||||0.001
72485900|NCT00239226|144499457|SUPERIORITY_OR_OTHER||Slope|3.93||||0.047|||||||Log Rank|||||||0.047
72485901|NCT00646906|144499473|SUPERIORITY|An analysis of variance, appropriate for a three factor experiment with cohort and dose as non-repeated factors and repeated measure order arranged in a two period cross-over design, was performed.|||||>|0.05|||||||ANOVA|||The primary hypothesis is that acetaminophen given two hours before aspirin will antagonize the effects of aspirin, while reversing the order of administration will not. Percent change from start (8:00 am on day 1) to finish (8:00 am on day 7) of period in serum thromboxane B2 for each order of drug administration will be primary endpoint of interest.||||>0.05
72485902|NCT00646906|144499474|SUPERIORITY|An analysis of variance, appropriate for a three factor experiment with cohort and dose as non-repeated factors and repeated measure order arranged in a two period cross-over design, was performed.|||||>|0.05|||||||ANOVA|||||||>0.05
72485903|NCT00953719|144499522|NON_INFERIORITY_OR_EQUIVALENCE|The prospectively planned primary endpoint analysis was a non-inferiority test of covariate adjusted 24 month or later Harris Hip score means with a 5 point non-inferiority margin. A prospective power analysis with an anticipated Harris Hip score standard deviation of 10.08 (for both treatment groups) indicated that sample sizes of 134 and 67 would provide approximately 95% statistical power for this non-inferiority test with a type 1 error rate of 5%.|Mean Difference (Final Values)|0.7|STANDARD_ERROR_OF_MEAN|1.24|<|0.001|ONE_SIDED|95.0|-1.4||||ANCOVA||||||-1.40|<0.001
72485904|NCT00953719|144499528|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.079||||0.952||95.0|||||Mixed Models Analysis|SAS PROC MIXED was used with an ante-dependence covariance structure.||A repeated measurements longitudinal model of Harris Hip scores was carried out to compare Harris Hip results between treatment groups across time.||||0.952
72485905|NCT03492554|144499534|OTHER||||||<|0.0001|||||||1 sided exact binomial test|||H0: Specificity = 92% H1: Specificity \> 92 Under the assumption that the true population specificity is 96.5%, 226 subjects who were diagnosed with SR based on the 12-lead ECG reference strip and where the device algorithm classification produced a result of AF or SR was calculated to provide at least 80% power to reject its null hypothesis, using a one-sided type I error of 0.025. To obtain readable waveforms approximately 300 subjects with no known diagnosis of AF were enrolled.||||<0.0001
72485906|NCT03492554|144499535|OTHER||||||<|0.0001|||||||1 sided exact binomial test|||H0: Sensitivity = 90% H1: Sensitivity \> 90% Under the assumption that the true population sensitivity is 95%, 231 subjects who were diagnosed with AF based on the 12-lead ECG reference strip and where the device algorithm classification produced a result of AF or SR was calculated to provide at least 80% power to reject the null hypothesis, using a one-sided type I error of 0.025. To obtain readable waveforms, a minimum of 260 subjects with a known diagnosis of AF were enrolled.||||<0.0001
72485907|NCT03492554|144499536|OTHER||||||<|0.0001|||||||1 sided exact binomial|||H0: agreement proportion of visual display= 0.8 H1: agreement proportion of visual display\> 0.8 Under the assumption that the true population agreement proportion of visual display was 90%, 88 subjects would provide at least 80% power to reject the null hypothesis using a one-sided type I error of 0.05. To account for obtaining readable waveforms, approximately 140 subjects (70 SR; 70 AF) were randomly selected.||||<0.0001
72485908|NCT03492554|144499537|OTHER||||||<|0.0001|||||||1 sided exact binomial|||H0: agreement proportion of R wave amplitude = 0.8 H1: agreement proportion of R wave amplitude \> 0.8 Under the assumption that the true population agreement proportion of R wave amplitude was 90%, 88 subjects would provide at least 80% power to reject the null hypothesis using a one-sided type I error of 0.05. To account for obtaining readable waveforms, approximately 140 subjects (70 SR; 70 AF) were randomly selected.||||<0.0001
72512991|NCT04047121|144556319|SUPERIORITY|||||||0.242|||||||Chi-squared|||||||0.2420
72512992|NCT04047121|144556319|SUPERIORITY||Odds Ratio (OR)|1.7474||||0.0869|TWO_SIDED|95.0|0.9222|3.3107|||Regression, Logistic|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||3.3107|0.9222|0.0869
72512993|NCT04047121|144556319|SUPERIORITY||Odds Ratio (OR)|1.1346||||0.8228|TWO_SIDED|95.0|0.3757|3.4266|||Regression, Logistic|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||3.4266|0.3757|0.8228
72576923|NCT00261443|144680717|SUPERIORITY_OR_OTHER_LEGACY|||||||0.279||95.0||||CMH General Association Test controlling for mood stabilizer.|Cochran-Mantel-Haenszel|||Week 12 Treatment Comparison||||0.279
72402700|NCT01480076|144311690|SUPERIORITY_OR_OTHER||difference of LS means|-6.4|STANDARD_ERROR_OF_MEAN|4.37||0.1414|TWO_SIDED||||||mixed effect model|||Month 9, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 psychological score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.1414
72512994|NCT04047121|144556319|SUPERIORITY||Odds Ratio (OR)|1.565||||0.4855|TWO_SIDED|95.0|0.4446|5.5086|||Regression, Logistic|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||5.5086|0.4446|0.4855
72512995|NCT04047121|144556321|SUPERIORITY|||||||0.5092|||||||Chi-squared|||||||0.5092
72512996|NCT04047121|144556321|SUPERIORITY|||||||0.0201|||||||Chi-squared|||||||0.0201
72512997|NCT04047121|144556321|SUPERIORITY|||||||0.2799|||||||Chi-squared|||||||0.2799
72512998|NCT04047121|144556321|SUPERIORITY||Odds Ratio (OR)|0.9021||||0.5772|TWO_SIDED|95.0|0.6281|1.2958|||Regression, Logistic|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||1.2958|0.6281|0.5772
72512999|NCT04047121|144556321|SUPERIORITY||Odds Ratio (OR)|1.3953||||0.3272|TWO_SIDED|95.0|0.7166|2.7169|||Regression, Logistic|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||2.7169|0.7166|0.3272
72513000|NCT04047121|144556321|SUPERIORITY||Odds Ratio (OR)|1.3527||||0.3011|TWO_SIDED|95.0|0.763|2.3983|||Regression, Logistic|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||2.3983|0.7630|0.3011
72402701|NCT01480076|144311690|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 12, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 psychological score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
72513001|NCT04047121|144556322|SUPERIORITY|||||||0.2931|||||||Chi-squared|||||||0.2931
72513002|NCT04047121|144556322|SUPERIORITY|||||||0.3135|||||||Chi-squared|||||||0.3135
72513003|NCT04047121|144556322|SUPERIORITY||||||<|0.0001|||||||Chi-squared|||||||<0.0001
72513004|NCT04047121|144556322|SUPERIORITY||Odds Ratio (OR)|0.8369||||0.6772|TWO_SIDED|95.0|0.3618|1.9356|||Regression, Logistic|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||1.9356|0.3618|0.6772
72513005|NCT04047121|144556322|SUPERIORITY||Odds Ratio (OR)|5.253||||0.0013|TWO_SIDED|95.0|1.9061|14.477|||Regression, Logistic|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||14.4770|1.9061|0.0013
72513006|NCT04047121|144556323|SUPERIORITY|||||||0.5217|||||||Chi-squared|||||||0.5217
72513007|NCT04047121|144556323|SUPERIORITY|||||||0.0432|||||||Chi-squared|||||||0.0432
72513008|NCT04047121|144556323|SUPERIORITY|||||||0.2573|||||||Chi-squared|||||||0.2573
72513009|NCT04047121|144556323|SUPERIORITY||Odds Ratio (OR)|0.8593||||0.5368|TWO_SIDED|95.0|0.5311|1.3902|||Regression, Logistic|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||1.3902|0.5311|0.5368
72513010|NCT04047121|144556323|SUPERIORITY||Odds Ratio (OR)|1.2892||||0.4685|TWO_SIDED|95.0|0.6488|2.5616|||Regression, Logistic|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||2.5616|0.6488|0.4685
72513011|NCT04047121|144556323|SUPERIORITY||Odds Ratio (OR)|1.3598||||0.3112|TWO_SIDED|95.0|0.7502|2.4648|||Regression, Logistic|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||2.4648|0.7502|0.3112
72513012|NCT04047121|144556324|SUPERIORITY|||||||0.409|||||||Chi-squared|||||||0.4090
72513013|NCT04047121|144556324|SUPERIORITY|||||||0.0249|||||||Chi-squared|||||||0.0249
72513014|NCT04047121|144556324|SUPERIORITY|||||||0.0103|||||||Chi-squared|||||||0.0103
72513015|NCT04047121|144556324|SUPERIORITY||Odds Ratio (OR)|1.1302||||0.5415|TWO_SIDED|95.0|0.763|1.6741|||Regression, Logistic|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||1.6741|0.7630|0.5415
72513016|NCT04047121|144556324|SUPERIORITY||Odds Ratio (OR)|2.0118||||0.0596|TWO_SIDED|95.0|0.9722|4.1632|||Regression, Logistic|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||4.1632|0.9722|0.0596
72513017|NCT04047121|144556324|SUPERIORITY||Odds Ratio (OR)|3.4823||||0.0002|TWO_SIDED|95.0|1.793|6.7633|||Regression, Logistic|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||6.7633|1.7930|0.0002
72513018|NCT04047121|144556325|SUPERIORITY|||||||0.2361|||||||Chi-squared|||||||0.2361
72513019|NCT04047121|144556325|SUPERIORITY|||||||0.7474|||||||Chi-squared|||||||0.7474
72513020|NCT04047121|144556325|SUPERIORITY|||||||0.2118|||||||Chi-squared|||||||0.2118
72576924|NCT00261443|144680717|SUPERIORITY_OR_OTHER_LEGACY|||||||0.247||95.0||||CMH General Association Test controlling for mood stabilizer.|Cochran-Mantel-Haenszel|||Week 24 Treatment Comparison||||0.247
72402702|NCT01480076|144311690|SUPERIORITY_OR_OTHER|||||||0.6279|||||||mixed effect model|||Month 12, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 psychological score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.6279
72402703|NCT01480076|144311690|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 12, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 psychological score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
72567716|NCT00076804|144666979|SUPERIORITY_OR_OTHER|||||||0.89||||||Logistic regression analysis \& Cox proportional hazards regression analyses were performed to compare outcomes after adjusting for the relevant covariates,including study arm, age, sex, baseline CD4 cell counts and viral load and pill count adherence|Chi-squared|one degree of freedom||Unadjusted endpoint analyses were conducted on an intention-to-treat basis using all patients enrolled to compare outcomes in the DOT vs. Self-ART arm. For viral load analyses, missing values were considered detectable (missing¼failure analysis). As-treated analyses were also conducted using patients remaining in the study with available data.Crosssectional comparisons between study groups were conducted using two sample t-test,Wilcoxon rank-sum test,chi-squared orFisher's exact and Kaplan-Meier||||0.89
72567717|NCT00076804|144666980|SUPERIORITY_OR_OTHER|||||||0.14||||||Logistic regression analysis \& Cox proportional hazards regression analyses were performed to compare outcomes after adjusting for the relevant covariates,including study arm, age, sex, baseline CD4 cell counts and viral load and pill count adherence|Wilcoxon (Mann-Whitney)|||Unadjusted endpoint analyses were conducted on an intention-to-treat basis using all patients enrolled to compare outcomes in the DOT vs. Self-ART arm. For viral load analyses, missing values were considered detectable (missing¼failure analysis). As-treated analyses were also conducted using patients remaining in the study with available data.Crosssectional comparisons between study groups were conducted using two sample t-test,Wilcoxon rank-sum test,chi-squared orFisher's exact and Kaplan-Meier||||0.14
72402704|NCT01480076|144311690|SUPERIORITY_OR_OTHER|||||||0.2239|||||||mixed effect model|||Month 12, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 psychological score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.2239
72485909|NCT01478360|144499540|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.166||||0.5392|TWO_SIDED|90.0|-0.617|0.285|||Mixed Models Analysis|||||0.285|-0.617|0.5392
72485910|NCT02289352|144499541|EQUIVALENCE|If the 90% confidence interval for the absolute difference between the proportion of patients considered a treatment success (at least a 2-grade improvement on both CEA and PSA over 6 hours+/-10 minutes) in the Test and Reference groups is contained within the range \[-20%, +20%\], then bioequivalence of the Test product to the Reference product is considered to have been demonstrated.|Mean Difference (Net)|-0.58|||||TWO_SIDED|90.0|-6.49|5.33||||||||5.33|-6.49|
72485911|NCT02289352|144499541|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
72485912|NCT02289352|144499541|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
72485913|NCT02289352|144499542|EQUIVALENCE|"The secondary efficacy variable is the proportion of patients with a clinical response of treatment success on Day 1.~If the 90% confidence interval for the absolute difference between the proportion of patients considered a treatment success (at least a 2-grade improvement on both the CEA and PSA over 6 hours+/-10 minutes) in the Test and Reference groups is contained within the range \[-20%, 20%\], then bioequivalence of the Test to Reference product is considered to have been demonstrated."|Mean Difference (Net)|6.94|||||TWO_SIDED|90.0|-1.54|15.41||||||||15.41|-1.54|
72485914|NCT02289352|144499542|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
72485915|NCT02289352|144499542|SUPERIORITY|||||||0.0045|||||||t-test, 2 sided|||||||0.0045
72485916|NCT00911625|144499580|SUPERIORITY||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|9.502||0.958|TWO_SIDED|95.0|-19.341|18.341|||t-test, 2 sided|||The null hypothesis is that there is no difference between the two treatment cohorts on their average blood glucose level||18.341|-19.341|.958
72485917|NCT00911625|144499581|SUPERIORITY||Odds Ratio (OR)|0.438||||0.0828|TWO_SIDED|95.0|0.172|1.114|||Regression, Logistic|||The null hypothesis is that there is no difference in the odds of experiencing at least one blood glucose level below 70 mg/dL between the two treatment cohorts.||1.114|0.172|.0828
72485918|NCT02101515|144499582|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.45|||||TWO_SIDED|95.0|0.22|0.93||||||||0.93|0.22|
72485919|NCT02101515|144499584|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|2.41|||||TWO_SIDED|95.0|0.67|8.4||||||||8.40|0.67|
72485920|NCT02101515|144499585|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.77|||||TWO_SIDED|95.0|0.41|1.45||||||||1.45|0.41|
72485921|NCT02101515|144499586|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|2.71|||||TWO_SIDED|95.0|1.3|5.62||||||||5.62|1.30|
72485922|NCT02101515|144499587|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.9|||||TWO_SIDED|95.0|0.06|13.92||||||||13.92|0.06|
72485923|NCT02101515|144499589|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|5.41|||||TWO_SIDED|95.0|0.68|42.9||||||||42.90|0.68|
72485924|NCT02101515|144499591|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.8|||||TWO_SIDED|95.0|0.46|1.54||||||||1.54|0.46|
72485925|NCT02101515|144499592|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.76|||||TWO_SIDED|95.0|0.39|1.49||||||||1.49|0.39|
72485926|NCT02101515|144499594|SUPERIORITY_OR_OTHER|||||||0.6|||||||t-test, 2 sided|||||||0.6
72485927|NCT02101515|144499598|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.3|||||TWO_SIDED|95.0|0.03|2.77||||||||2.77|0.03|
72485928|NCT02463071|144499606|SUPERIORITY||Mean Difference (Final Values)|-26.72|STANDARD_ERROR_OF_MEAN|4.96|<|0.0001|TWO_SIDED|95.0|-36.55|-16.88|||ANCOVA|Baseline TG and statin usage were included as covariates.||||-16.88|-36.55|<0.0001
72485929|NCT02463071|144499606|SUPERIORITY||Mean Difference (Final Values)|-32.92|STANDARD_ERROR_OF_MEAN|5.04|<|0.0001|TWO_SIDED|95.0|-42.93|-22.92|||ANCOVA|Baseline TG and statin usage were included as covariates.||||-22.92|-42.93|<0.0001
72485930|NCT00698932|144499613|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.5|STANDARD_ERROR_OF_MEAN|0.079|<|0.0001||95.0|-0.65|-0.34|||ANCOVA|\*adjusted for baseline HbA1c||||-0.34|-0.65|<0.0001
72485931|NCT00698932|144499614|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.73|STANDARD_ERROR_OF_MEAN|0.17|<|0.0001||95.0|-1.06|-0.39|||ANCOVA|\*adjusted for baseline FPG||||-0.39|-1.06|<0.0001
72485932|NCT00698932|144499615|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-13.12|STANDARD_ERROR_OF_MEAN|3.053|<|0.0001||95.0|-19.12|-7.13|||ANCOVA|\*adjusted for baseline FPG||||-7.13|-19.12|<0.0001
72624111|NCT01892189|144778533|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0134|STANDARD_ERROR_OF_MEAN|0.1538||0.931|TWO_SIDED|95.0|-0.2991|0.326|||ANOVA||Difference between least square means of TAK-063 10 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Left Striatum: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.3260|-0.2991|0.931
72624112|NCT01892189|144778533|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1164|STANDARD_ERROR_OF_MEAN|0.14608||0.431|TWO_SIDED|95.0|-0.4133|0.1804|||ANOVA||Difference between least square means of TAK-063 30 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Left Striatum: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.1804|-0.4133|0.431
72485933|NCT00698932|144499616|SUPERIORITY_OR_OTHER||Median Difference (Net)|-182.0|STANDARD_ERROR_OF_MEAN|54.4||0.001||95.0|-289.0|-74.0|||ANCOVA|\*adjusted for baseline PPG AUC||||-74|-289|0.001
72513021|NCT04047121|144556325|SUPERIORITY||Odds Ratio (OR)|1.3811||||0.1978|TWO_SIDED|95.0|0.8449|2.2576|||Regression, Logistic|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||2.2576|0.8449|0.1978
72624113|NCT01892189|144778533|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3269|STANDARD_ERROR_OF_MEAN|0.13362||0.02|TWO_SIDED|95.0|-0.5985|-0.0554|||ANOVA||Difference between least square means of TAK-063 3 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Right Striatum: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||-0.0554|-0.5985|0.020
72624114|NCT01892189|144778533|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.0845|STANDARD_ERROR_OF_MEAN|0.14418||0.562|TWO_SIDED|95.0|-0.3775|0.2085|||ANOVA||Difference between least square means of TAK-063 10 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Right Striatum: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.2085|-0.3775|0.562
72624115|NCT01892189|144778533|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1727|STANDARD_ERROR_OF_MEAN|0.13695||0.216|TWO_SIDED|95.0|-0.451|0.1056|||ANOVA||Difference between least square means of TAK-063 30 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Right Striatum: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.1056|-0.4510|0.216
72402705|NCT01480076|144311690|SUPERIORITY_OR_OTHER||difference of LS means|-7.5|STANDARD_ERROR_OF_MEAN|2.67||0.0049|TWO_SIDED||||||mixed effect model|||Month 12, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 psychological score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0049
72485934|NCT00698932|144499617|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3280.0|STANDARD_ERROR_OF_MEAN|980.0||0.001||95.0|-5214.0|-1345.0|||ANCOVA|\*adjusted for baseline PPG AUC||||-1345|-5214|0.001
72485935|NCT00698932|144499618|SUPERIORITY_OR_OTHER||Median Difference (Net)|17.0|||<|0.0001||95.0|8.9|24.9|||ANCOVA|||||24.9|8.9|<0.0001
72513022|NCT04047121|144556325|SUPERIORITY||Odds Ratio (OR)|1.0614||||0.8893|TWO_SIDED|95.0|0.4587|2.4559|||Regression, Logistic|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||2.4559|0.4587|0.8893
72513023|NCT04047121|144556325|SUPERIORITY||Odds Ratio (OR)|0.5811||||0.1553|TWO_SIDED|95.0|0.2748|1.2286|||Regression, Logistic|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||1.2286|0.2748|0.1553
72485936|NCT02243865|144499720|SUPERIORITY|||||||0.6938|||||||ANCOVA|In the analyses the baseline value was used as a covariate in order to adjust for initial differences at treatment start.||||||0.6938
72485937|NCT02243865|144499721|SUPERIORITY|||||||0.6557|||||||ANCOVA|In the analyses the baseline value was used as a covariate in order to adjust for initial differences at treatment start.||Null hypothesis: There is no difference between the active treatment and placebo groups in change from baseline in number of migraine days during the 1st month of the three month post treatment investigation duration||||0.6557
72624116|NCT01892189|144778533|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.0084|STANDARD_ERROR_OF_MEAN|0.17609||0.962|TWO_SIDED|95.0|-0.3663|0.3495|||ANOVA||Difference between least square means of TAK-063 3 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Left Amygdala: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.3495|-0.3663|0.962
72485938|NCT02243865|144499721|SUPERIORITY|||||||0.515|||||||ANCOVA|In the analyses the baseline value was used as a covariate in order to adjust for initial differences at treatment start.||Null hypothesis: There is no difference between the active treatment and placebo groups in change from baseline in number of migraine days during the 2nd month of the three month post treatment investigation duration||||0.515
72485939|NCT02243865|144499721|SUPERIORITY|||||||0.3256|||||||ANCOVA|In the analyses the baseline value was used as a covariate in order to adjust for initial differences at treatment start.||Null hypothesis: There is no difference between the active treatment and placebo groups in change from baseline in number of migraine days during the 3rd month of the three month post treatment investigation duration||||0.3256
72513024|NCT04047121|144556326|SUPERIORITY|||||||0.6767|||||||Chi-squared|||||||0.6767
72513025|NCT04047121|144556326|SUPERIORITY|||||||0.1141|||||||Chi-squared|||||||0.1141
72513026|NCT04047121|144556326|SUPERIORITY|||||||0.1497|||||||Chi-squared|||||||0.1497
72513027|NCT04047121|144556326|SUPERIORITY||Odds Ratio (OR)|0.8556||||0.5228|TWO_SIDED|95.0|0.5303|1.3804|||Regression, Logistic|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||1.3804|0.5303|0.5228
72513028|NCT04047121|144556326|SUPERIORITY||Odds Ratio (OR)|2.5125||||0.0277|TWO_SIDED|95.0|1.1062|5.7063|||Regression, Logistic|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||5.7063|1.1062|0.0277
72513029|NCT04047121|144556326|SUPERIORITY||Odds Ratio (OR)|0.6993||||0.324|TWO_SIDED|95.0|0.3435|1.4236|||Regression, Logistic|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||1.4236|0.3435|0.3240
72513030|NCT04047121|144556327|SUPERIORITY|||||||0.6318|||||||t-test, 2 sided|||||||0.6318
72513031|NCT04047121|144556327|SUPERIORITY|||||||0.3802|||||||t-test, 2 sided|||||||0.3802
72513032|NCT04047121|144556327|SUPERIORITY|||||||0.2424|||||||t-test, 2 sided|||||||0.2424
72513033|NCT04047121|144556327|SUPERIORITY||Odds Ratio (OR)|0.0347||||0.1753|TWO_SIDED|95.0|-0.0155|0.0848|||Regression, Linear|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||0.0848|-0.0155|0.1753
72513034|NCT04047121|144556327|SUPERIORITY||Odds Ratio (OR)|0.0194||||0.6114|TWO_SIDED|95.0|-0.0553|0.0941|||Regression, Linear|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||0.0941|-0.0553|0.6114
72513035|NCT04047121|144556327|SUPERIORITY||Odds Ratio (OR)|0.0345||||0.2977|TWO_SIDED|95.0|-0.0304|0.0993|||Regression, Linear|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||0.0993|-0.0304|0.2977
72513036|NCT04047121|144556328|SUPERIORITY|||||||0.1473|||||||t-test, 2 sided|||||||0.1473
72513037|NCT04047121|144556328|SUPERIORITY|||||||0.8747|||||||t-test, 2 sided|||||||0.8747
72513038|NCT04047121|144556328|SUPERIORITY|||||||0.5265|||||||t-test, 2 sided|||||||0.5265
72513039|NCT04047121|144556328|SUPERIORITY||Odds Ratio (OR)|-0.0457||||0.2522|TWO_SIDED|95.0|-0.1239|0.0325|||Regression, Linear|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||0.0325|-0.1239|0.2522
72513040|NCT04047121|144556328|SUPERIORITY||Odds Ratio (OR)|0.0278||||0.6701|TWO_SIDED|95.0|-0.1003|0.1559|||Regression, Linear|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||0.1559|-0.1003|0.6701
72567718|NCT00076804|144666981|SUPERIORITY_OR_OTHER|||||||0.61||||||Logistic regression analysis \& Cox proportional hazards regression analyses were performed to compare outcomes after adjusting for the relevant covariates,including study arm, age, sex, baseline CD4 cell counts and viral load and pill count adherence|Wilcoxon (Mann-Whitney)|||Unadjusted endpoint analyses were conducted on an intention-to-treat basis using all patients enrolled to compare outcomes in the DOT vs. Self-ART arm. For viral load analyses, missing values were considered detectable (missing¼failure analysis). As-treated analyses were also conducted using patients remaining in the study with available data.Crosssectional comparisons between study groups were conducted using two sample t-test,Wilcoxon rank-sum test,chi-squared orFisher's exact and Kaplan-Meier||||0.61
72567719|NCT03852459|144666987|SUPERIORITY|||||||0.4272|||||||ANCOVA|||||||0.4272
72513041|NCT04047121|144556328|SUPERIORITY||Odds Ratio (OR)|0.1693||||0.1017|TWO_SIDED|95.0|-0.0334|0.372|||Regression, Linear|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||0.3720|-0.0334|0.1017
72513042|NCT04047121|144556329|SUPERIORITY|||||||0.2246|||||||t-test, 2 sided|||||||0.2246
72513043|NCT04047121|144556329|SUPERIORITY|||||||0.2101|||||||t-test, 2 sided|||||||0.2101
72513044|NCT04047121|144556329|SUPERIORITY|||||||0.003|||||||t-test, 2 sided|||||||0.0030
72513045|NCT04047121|144556329|SUPERIORITY||Odds Ratio (OR)|0.414||||0.3324|TWO_SIDED|95.0|-0.4231|1.2511|||Regression, Linear|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||1.2511|-0.4231|0.3324
72513046|NCT04047121|144556329|SUPERIORITY||Odds Ratio (OR)|1.1712||||0.1367|TWO_SIDED|95.0|-0.3713|2.7138|||Regression, Linear|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||2.7138|-0.3713|0.1367
72513047|NCT04047121|144556329|SUPERIORITY||Odds Ratio (OR)|1.8099||||0.0028|TWO_SIDED|95.0|0.6219|2.9978|||Regression, Linear|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||2.9978|0.6219|0.0028
72513048|NCT04047121|144556330|SUPERIORITY|||||||0.2667|||||||t-test, 2 sided|||||||0.2667
72513049|NCT04047121|144556330|SUPERIORITY|||||||0.657|||||||t-test, 2 sided|||||||0.6570
72513050|NCT04047121|144556330|SUPERIORITY|||||||0.5403|||||||t-test, 2 sided|||||||0.5403
72513051|NCT04047121|144556330|SUPERIORITY||Odds Ratio (OR)|0.9159||||0.1167|TWO_SIDED|95.0|-0.2283|2.06|||Regression, Linear|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||2.0600|-0.2283|0.1167
72402706|NCT01480076|144311690|SUPERIORITY_OR_OTHER||difference of LS means|-4.1|STANDARD_ERROR_OF_MEAN|4.32||0.3457|TWO_SIDED||||||mixed effect model|||Month 12, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 psychological score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.3457
72402707|NCT01480076|144311691|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Overall, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the total ALS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
72513052|NCT04047121|144556330|SUPERIORITY||Odds Ratio (OR)|-0.0336||||0.9722|TWO_SIDED|95.0|-1.9238|1.8567|||Regression, Linear|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||1.8567|-1.9238|0.9722
72513053|NCT04047121|144556330|SUPERIORITY||Odds Ratio (OR)|0.2064||||0.8455|TWO_SIDED|95.0|-1.8689|2.2817|||Regression, Logistic|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||2.2817|-1.8689|0.8455
72513054|NCT04047121|144556331|SUPERIORITY|||||||0.3142|||||||t-test, 2 sided|||||||0.3142
72513055|NCT04047121|144556331|SUPERIORITY|||||||0.2465|||||||t-test, 2 sided|||||||0.2465
72513056|NCT04047121|144556331|SUPERIORITY|||||||0.5933|||||||t-test, 2 sided|||||||0.5933
72513057|NCT04047121|144556331|SUPERIORITY||Odds Ratio (OR)|-0.0089||||0.7815|TWO_SIDED|95.0|-0.0716|0.0538|||Regression, Linear|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||0.0538|-0.0716|0.7815
72513058|NCT04047121|144556331|SUPERIORITY||Odds Ratio (OR)|0.0337||||0.4446|TWO_SIDED|95.0|-0.0528|0.1202|||Regression, Linear|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||0.1202|-0.0528|0.4446
72513059|NCT04047121|144556331|SUPERIORITY||Odds Ratio (OR)|-0.0333||||0.4733|TWO_SIDED|95.0|-0.1243|0.0577|||Regression, Linear|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||0.0577|-0.1243|0.4733
72513060|NCT04047121|144556332|SUPERIORITY|||||||0.0658|||||||t-test, 2 sided|||||||0.0658
72513061|NCT04047121|144556332|SUPERIORITY|||||||0.3785|||||||t-test, 2 sided|||||||0.3785
72513062|NCT04047121|144556332|SUPERIORITY|||||||0.6202|||||||t-test, 2 sided|||||||0.6202
72513063|NCT04047121|144556332|SUPERIORITY||Odds Ratio (OR)|-0.0425||||0.2523|TWO_SIDED|95.0|-0.1154|0.0303|||Regression, Linear|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||0.0303|-0.1154|0.2523
72513064|NCT04047121|144556332|SUPERIORITY||Odds Ratio (OR)|-0.0388||||0.4068|TWO_SIDED|95.0|-0.1305|0.0529|||Regression, Linear|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||0.0529|-0.1305|0.4068
72513065|NCT04047121|144556332|SUPERIORITY||Odds Ratio (OR)|0.0706||||0.5858|TWO_SIDED|95.0|-0.1833|0.3244|||Regression, Linear|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||0.3244|-0.1833|0.5858
72513066|NCT04047121|144556333|SUPERIORITY|||||||0.3832|||||||t-test, 2 sided|||||||0.3832
72513067|NCT04047121|144556333|SUPERIORITY|||||||0.4631|||||||t-test, 2 sided|||||||0.4631
72513068|NCT04047121|144556333|SUPERIORITY|||||||0.6202|||||||t-test, 2 sided|||||||0.6202
72513069|NCT04047121|144556333|SUPERIORITY||Odds Ratio (OR)|-0.5353||||0.3158|TWO_SIDED|95.0|-1.5812|0.5107|||Regression, Linear|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||0.5107|-1.5812|0.3158
72402708|NCT01480076|144311691|SUPERIORITY_OR_OTHER|||||||0.2087|||||||mixed effect model|||Overall, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the total ALS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.2087
72513070|NCT04047121|144556333|SUPERIORITY||Odds Ratio (OR)|1.3543||||0.1016|TWO_SIDED|95.0|-0.2669|2.9755|||Regression, Linear|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||2.9755|-0.2669|0.1016
72513071|NCT04047121|144556333|SUPERIORITY||Odds Ratio (OR)|0.8677||||0.2576|TWO_SIDED|95.0|-0.6347|2.37|||Regression, Linear|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||2.3700|-0.6347|0.2576
72513072|NCT04047121|144556334|SUPERIORITY|||||||0.3107|||||||t-test, 2 sided|||||||0.3107
72513073|NCT04047121|144556334|SUPERIORITY|||||||0.3735|||||||t-test, 2 sided|||||||0.3735
72513074|NCT04047121|144556334|SUPERIORITY|||||||0.3863|||||||t-test, 2 sided|||||||0.3863
72576925|NCT00261443|144680717|SUPERIORITY_OR_OTHER_LEGACY|||||||0.329||95.0||||CMH General Association Test controlling for mood stabilizer.|Cochran-Mantel-Haenszel|||Week 36 Treatment Comparison||||0.329
72485940|NCT02243865|144499721|SUPERIORITY|||||||0.4086|||||||ANCOVA|In the analyses the baseline value was used as a covariate in order to adjust for initial differences at treatment start.||Null hypothesis: There is no difference between the active treatment and placebo groups in change from baseline in number of migraine days during the final four weeks of the three month post treatment investigation duration.||||0.4086
72485941|NCT03044249|144499729|SUPERIORITY||Response Ratio|4.0||||0.48|TWO_SIDED|90.0|-18.0|25.0|||Fisher Exact|||||25|-18|0.48
72485942|NCT03044249|144499731|SUPERIORITY||Mean Difference (Final Values)|-5.28||||0.14|TWO_SIDED|90.0|-11.16|0.61|||Mixed Models Analysis|||||0.61|-11.16|0.14
72485943|NCT03044249|144499732|SUPERIORITY||Mean Difference (Final Values)|-1.58||||0.37|TWO_SIDED|90.0|-4.47|1.31|||Mixed Models Analysis|||||1.31|-4.47|0.37
72485944|NCT03044249|144499736|SUPERIORITY||Mean Difference (Final Values)|-0.08||||0.94|TWO_SIDED|90.0|-2.0|1.84|||Mixed Models Analysis|||||1.84|-2.00|0.94
72485945|NCT01368042|144499745|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.7|STANDARD_DEVIATION|32.9||0.03|||||||Wilcoxon signed rank test-paired samples||n=234 (paired samples)|||||0.03
72485946|NCT01368042|144499746|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.3|STANDARD_DEVIATION|57.2||0.05|||||||Wilcoxon signed rank test-paired samples||n=231 (paired samples)|||||0.05
72485947|NCT01368042|144499747|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.8|STANDARD_DEVIATION|56.4||0.003|||||||Wilcoxon signed rank test-paired samples||n=231 (paired samples)|||||0.003
72485948|NCT01368042|144499748|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.5|STANDARD_DEVIATION|30.5|<|0.001|||||||Wilcoxon signed rank test-paired samples||n=235 (paired samples)|||||<0.001
72485949|NCT01368042|144499749|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.4|STANDARD_DEVIATION|27.2|<|0.001|||||||Wilcoxon signed rank test-paired samples||n=235 (paired samples)|||||<0.001
72485950|NCT01368042|144499750|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.3|STANDARD_DEVIATION|35.3|<|0.001|||||||Wilcoxon signed rank test-paired samples||n=235 (paired samples)|||||<0.001
72485951|NCT01368042|144499751|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.7|STANDARD_DEVIATION|34.8|<|0.001|||||||Wilcoxon signed rank test-paired samples||n=234 (paired samples)|||||<0.001
72513075|NCT04047121|144556334|SUPERIORITY||Odds Ratio (OR)|-1.0337||||0.1918|TWO_SIDED|95.0|-2.5858|0.5184|||Regression, Linear|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||0.5184|-2.5858|0.1918
72513076|NCT04047121|144556334|SUPERIORITY||Odds Ratio (OR)|-0.9749||||0.4281|TWO_SIDED|95.0|-3.3864|1.4366|||Regression, Linear|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||1.4366|-3.3864|0.4281
72513077|NCT04047121|144556334|SUPERIORITY||Odds Ratio (OR)|-1.8599||||0.1014|TWO_SIDED|95.0|-4.0854|0.3657|||Regression, Linear|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||0.3657|-4.0854|0.1014
72513078|NCT04047121|144556335|SUPERIORITY|||||||0.4555|||||||t-test, 2 sided|||||||0.4555
72485952|NCT01368042|144499752|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3|STANDARD_DEVIATION|20.9||0.38|||||||Wilcoxon signed rank test-paired samples||n=235 (paired samples)|||||0.38
72485953|NCT01368042|144499753|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.0|STANDARD_DEVIATION|32.0|<|0.001|||||||Wilcoxon signed rank test-paired samples||n=235 (paired samples)|||||<0.001
72485954|NCT01368042|144499754|SUPERIORITY_OR_OTHER|||||||0.03|||||||Generalized Estimating Equation approach|Generalized Estimating Equation approach (autoregressive structure)||Physical functioning scale||||0.03
72485955|NCT01368042|144499754|SUPERIORITY_OR_OTHER|||||||0.02|||||||Generalized Estimating Equation approach|Generalized Estimating Equation approach (autoregressive structure)||Role functioning due to physical health scale||||0.02
72485956|NCT01368042|144499754|SUPERIORITY_OR_OTHER|||||||0.01|||||||Generalized Estimating Equation approach|Generalized Estimating Equation approach (autoregressive structure)||Role functioning due to emotional problems scale||||0.01
72513079|NCT04047121|144556335|SUPERIORITY|||||||0.7164|||||||t-test, 2 sided|||||||0.7164
72513080|NCT04047121|144556335|SUPERIORITY|||||||0.2456|||||||t-test, 2 sided|||||||0.2456
72485957|NCT01368042|144499754|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Generalized Estimating Equation approach|Generalized Estimating Equation approach (autoregressive structure)||Energy/fatigue scale||||<0.001
72485958|NCT01368042|144499754|SUPERIORITY_OR_OTHER|||||||0.002|||||||Generalized Estimating Equation approach|Generalized Estimating Equation approach (autoregressive structure)||Emotional well-being scale||||0.002
72485959|NCT01368042|144499754|SUPERIORITY_OR_OTHER|||||||0.002|||||||Generalized Estimating Equation approach|Generalized Estimating Equation approach (autoregressive structure)||Social functioning scale||||0.002
72485960|NCT01368042|144499754|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Generalized Estimating Equation approach|Generalized Estimating Equation approach (autoregressive structure)||Bodily pain scale||||<0.001
72485961|NCT01368042|144499754|SUPERIORITY_OR_OTHER|||||||0.56|||||||Generalized Estimating Equation approach|Generalized Estimating Equation approach (autoregressive structure)||General health perceptions scale||||0.56
72485962|NCT01368042|144499755|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.0|STANDARD_DEVIATION|41.6||0.001|||||||Wilcoxon signed rank test-paired samples||n=235 (paired samples)|||||0.001
72485963|NCT01368042|144499756|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2|STANDARD_DEVIATION|1.4||0.03|||||||Wilcoxon signed rank test-paired samples||n=235 (paired samples)|||||0.03
72485964|NCT01368042|144499757|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1|STANDARD_DEVIATION|0.9||0.06|||||||Wilcoxon signed rank test-paired samples||n=235 (paired samples)|||||0.06
72485965|NCT01368042|144499758|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.06|STANDARD_DEVIATION|1.7||0.84|||||||Wilcoxon signed rank test-paired samples||n=234 (paired samples)|||||0.84
72485966|NCT01368042|144499759|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01|STANDARD_DEVIATION|16.5||0.67|||||||Wilcoxon signed rank test-paired samples||n=234 (paired samples)|||||0.67
72485967|NCT01368042|144499760|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-21.4|STANDARD_DEVIATION|324.8||0.02|||||||Wilcoxon signed rank test-paired samples||n= 215 (paired samples)|||||0.02
72513081|NCT04047121|144556335|SUPERIORITY||Odds Ratio (OR)|0.0568||||0.0962|TWO_SIDED|95.0|-0.0101|0.1238|||Regression, Linear|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||0.1238|-0.0101|0.0962
72402709|NCT01480076|144311691|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Overall, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the total ALS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
72485968|NCT01368042|144499761|SUPERIORITY_OR_OTHER|||||||0.12|||||||Generalized Estimating Equation approach|Generalized Estimating Equation approach (autoregressive structure)||||||0.12
72485969|NCT00955279|144499762|SUPERIORITY_OR_OTHER|||||||0.543|||||||ANCOVA|||||||0.543
72485970|NCT00955279|144499762|SUPERIORITY_OR_OTHER|||||||0.126|||||||ANCOVA|||||||0.126
72485971|NCT00955279|144499763|SUPERIORITY_OR_OTHER|||||||0.896|||||||Linear Contrasts Test|||||||0.896
72485972|NCT00955279|144499763|SUPERIORITY_OR_OTHER|||||||0.063|||||||Linear Contrasts Test|||||||0.063
72485973|NCT00955279|144499764|SUPERIORITY_OR_OTHER|||||||0.374|||||||Linear Contrasts Test|||||||0.374
72513082|NCT04047121|144556335|SUPERIORITY||Odds Ratio (OR)|-0.0432||||0.3844|TWO_SIDED|95.0|-0.1405|0.0541|||Regression, Linear|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||0.0541|-0.1405|0.3844
72567720|NCT00257920|144666997|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.004|STANDARD_ERROR_OF_MEAN|0.009||0.67||95.0|-0.023|0.015||No adjustment was made for multiple comparisons. A single hypothesis was tested by the primary efficacy analysis. All hypothesis tests were two-tailed and P-values \<= 0.050 were considered statistically significant.|Mixed Models Analysis|||The null hypothesis was that there is no difference in the mean calcium absorption fraction between Zemplar Injection and Hectorol Injection. The power calculation applied to the primary efficacy analysis.||0.015|-0.023|0.670
72485974|NCT00955279|144499764|SUPERIORITY_OR_OTHER|||||||0.073|||||||Linear Contrasts Test|||||||0.073
72513083|NCT04047121|144556335|SUPERIORITY||Odds Ratio (OR)|0.0233||||0.5899|TWO_SIDED|95.0|-0.0615|0.1082|||Regression, Linear|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||0.1082|-0.0615|0.5899
72513084|NCT04047121|144556336|SUPERIORITY|||||||0.4133|||||||t-test, 2 sided|||||||0.4133
72485975|NCT00955279|144499765|SUPERIORITY_OR_OTHER|||||||0.1931|||||||Fisher Exact|||||||0.1931
72485976|NCT00955279|144499765|SUPERIORITY_OR_OTHER|||||||0.2772|||||||Fisher Exact|||||||0.2772
72485977|NCT00955279|144499766|SUPERIORITY_OR_OTHER|||||||0.451|||||||Linear Contrast Test|||||||0.451
72485978|NCT00955279|144499766|SUPERIORITY_OR_OTHER|||||||0.546|||||||Linear Contrast Test|||||||0.546
72485979|NCT04207801|144499774|SUPERIORITY|||||||0.01|||||||Fisher Exact|||Efficacy of AUR101 was tested against placebo with respect to the primary endpoint (PASI75 response). A sample size of 25 in each of the three arms provided an 80% power with a one-sided Type I error of 0.05, if the true placebo response rate was 7% and the response rate on investigational arm(s) was 35%. The sample size was increased to 30 to account for \~ 15-20% dropouts over the study period.||||0.01
72485980|NCT00053703|144499777|SUPERIORITY_OR_OTHER|||||||0.05|||||||Mixed Models Analysis|||||||0.05
72485981|NCT01500525|144499783|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|3.0|||<|0.05|ONE_SIDED|95.0|||||Regression, Cox|||||||<0.05
72485982|NCT04166383|144499785|OTHER|||||||0.1||||||P≤0.10 (alpha 0.1); power = 90% (beta 0.1)|Kaplan-Meier|||||||0.10
72513085|NCT04047121|144556336|SUPERIORITY|||||||0.7171|||||||t-test, 2 sided|||||||0.7171
72513086|NCT04047121|144556336|SUPERIORITY|||||||0.8609|||||||t-test, 2 sided|||||||0.8609
72513087|NCT04047121|144556336|SUPERIORITY||Odds Ratio (OR)|-0.0445||||0.6224|TWO_SIDED|95.0|-0.2218|0.1327|||Regression, Linear|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||0.1327|-0.2218|0.6224
72513088|NCT04047121|144556336|SUPERIORITY||Odds Ratio (OR)|-0.0884||||0.5655|TWO_SIDED|95.0|-0.39|0.2132|||Regression, Linear|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||0.2132|-0.3900|0.5655
72513089|NCT04047121|144556336|SUPERIORITY||Odds Ratio (OR)|0.1809||||0.4044|TWO_SIDED|95.0|-0.2444|0.6062|||Regression, Linear|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||0.6062|-0.2444|0.4044
72513090|NCT04047121|144556337|SUPERIORITY|||||||0.0104|||||||t-test, 2 sided|||||||0.0104
72513091|NCT04047121|144556337|SUPERIORITY|||||||0.5949|||||||t-test, 2 sided|||||||0.5949
72513092|NCT04047121|144556337|SUPERIORITY|||||||0.0801|||||||t-test, 2 sided|||||||0.0801
72485983|NCT03044886|144499792|SUPERIORITY|||||||0.576|||||||ANOVA|||One-way analysis of variance (ANOVA) and Neuman-Keuel test were carried out to determine difference between groups.||||0.576
72485984|NCT03044886|144499793|SUPERIORITY|||||||0.489|||||||ANOVA|||||||0.489
72485985|NCT03044886|144499794|SUPERIORITY|||||||0.042|||||||ANOVA|||||||0.042
72485986|NCT03044886|144499794|SUPERIORITY|||||||0.041|||||||ANOVA|||One-way analysis of variance (ANOVA) and Neuman-Keuel test were carried out to determine changes from 3 month to 6 month of all groups.||||0.041
72513093|NCT04047121|144556337|SUPERIORITY||Odds Ratio (OR)|-3.7075||||0.0072|TWO_SIDED|95.0|-6.411|-1.004|||Regression, Linear|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||-1.0040|-6.4110|0.0072
72513094|NCT04047121|144556337|SUPERIORITY||Odds Ratio (OR)|-1.4296||||0.5406|TWO_SIDED|95.0|-6.008|3.1489|||Regression, Linear|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||3.1489|-6.0080|0.5406
72567721|NCT00257920|144666998|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.005|STANDARD_ERROR_OF_MEAN|0.009||0.573||95.0|-0.024|0.014||No adjustment was made for multiple comparisons. A single hypothesis was tested by the primary efficacy analysis. All hypothesis tests were two-tailed and P-values \<=0.050 were considered statistically significant.|ANOVA|||The null hypothesis was that there is no difference in mean calcium absorption between Zemplar and Hectorol. Approximately 42 subjects were to be randomized assuming 36 subjects would available in the per-protocol set. A sample size of 36 subjects has 80% power to detect a mean difference of -0.018 assuming the Zemplar group mean is 0.139, the Hectorol group mean is 0.157 and the STD is 0.037. The ANOVA model included effects for sequence, subject-within-sequence, period and treatment regimen.||0.014|-0.024|0.573
72567722|NCT03508687|144666999|OTHER|||||||0.517||||||paired t test; baseline vs. week 12 (n = 5)|t-test, 2 sided|||||||0.517
72402710|NCT01480076|144311691|SUPERIORITY_OR_OTHER|||||||0.4487|||||||mixed effect model|||Overall, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the total ALS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.4487
72402711|NCT01480076|144311691|SUPERIORITY_OR_OTHER||difference of LS means|-2.1|STANDARD_ERROR_OF_MEAN|0.64||0.0013|TWO_SIDED||||||mixed effect model|||Overall, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the total ALS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0013
72402712|NCT01480076|144311691|SUPERIORITY_OR_OTHER||difference of LS means|-2.7|STANDARD_ERROR_OF_MEAN|1.15||0.0188|TWO_SIDED||||||mixed effect model|||Overall, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the total ALS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0188
72485987|NCT03044886|144499795|SUPERIORITY|||||||0.71|||||||ANCOVA|||One-way analysis of variance (ANOVA) and Neuman-Keuel test were carried out to determine difference between groups.||||0.710
72485988|NCT03044886|144499796|SUPERIORITY|||||||0.34|||||||ANOVA|||||||0.340
72485989|NCT03044886|144499797|SUPERIORITY|||||||0.048|||||||ANOVA|||||||0.048
72485990|NCT03044886|144499797|SUPERIORITY|||||||0.038|||||||ANOVA|||One-way analysis of variance (ANOVA) and Neuman-Keuel test were carried out to determine changes from 3 month to 6 month of all groups.||||0.038
72485991|NCT03044886|144499798|SUPERIORITY|||||||0.521|||||||ANOVA|||One-way analysis of variance (ANOVA) and Neuman-Keuel test were carried out to determine difference between groups.||||0.521
72567723|NCT03508687|144666999|OTHER|||||||0.345|||||||Wilcoxon (Mann-Whitney)|Wilcoxon Signed Ranks Test (n = 5)||||||0.345
72567724|NCT03629028|144667020|NON_INFERIORITY|Data compared to meta-analysis conducted in Sardo et al., 2017||||||0.05|||||||Chi-squared|Chi-squared or Fisher's test statistic was used to compare the categorical variables.||The sample size was calculated based on the study of Sardo et al. The website http://powerandsamplesize.com/Calculators was used. As a result of the sample size calculation with 90% power and 0.05 alpha error, it was planned to include 141 patients in each group.||||0.05
72485992|NCT03044886|144499799|SUPERIORITY|||||||0.742|||||||ANOVA|||One-way analysis of variance (ANOVA) and Neuman-Keuel test were carried out to determine difference between groups.||||0.742
72567725|NCT02728752|144667029|SUPERIORITY||Mean Difference (Net)|-8.0|||<|0.0001|TWO_SIDED|95.0|-11.5|-4.6|||ANCOVA|With treatment, stratum and baseline as fixed effects, and site as random effect|Difference in LS Means of changes from baseline to week 16 (Octagam - Placebo)|LS Means difference between changes from baseline to week 16 for Total Activity Score||-4.6|-11.5|<0.0001
72485993|NCT03044886|144499800|SUPERIORITY||||||<|0.05|||||||ANOVA|||One-way analysis of variance (ANOVA) and Neuman-Keuel test were carried out to determine difference between groups.||||<0.05
72485994|NCT03044886|144499800|SUPERIORITY|||||||0.073|||||||ANOVA|||One-way analysis of variance (ANOVA) and Neuman-Keuel test were carried out to determine changes from 3 month to 6 month of all groups.||||0.073
72485995|NCT03044886|144499801|SUPERIORITY|||||||0.348|||||||ANOVA|||One-way analysis of variance (ANOVA) and Neuman-Keuel test were carried out to determine difference between groups.||||0.348
72485996|NCT03044886|144499802|SUPERIORITY|||||||0.685|||||||ANOVA|||One-way analysis of variance (ANOVA) and Neuman-Keuel test were carried out to determine difference between groups.||||0.685
72485997|NCT03044886|144499803|SUPERIORITY|||||||0.075|||||||ANOVA|||One-way analysis of variance (ANOVA) and Neuman-Keuel test were carried out to determine difference between groups.||||0.075
72485998|NCT03044886|144499803|SUPERIORITY|||||||0.083|||||||ANOVA|||One-way analysis of variance (ANOVA) and Neuman-Keuel test were carried out to determine changes from 3 month to 6 month of all groups.||||0.083
72485999|NCT01159912|144499831|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.146||||0.009|TWO_SIDED|95.0|0.036|0.257|||ANCOVA|||||0.257|0.036|0.009
72567726|NCT02728752|144667035|SUPERIORITY||Median Difference (Net)|8.6||||0.0001|TWO_SIDED|95.0|4.4|12.8|||ANCOVA|With treatment, stratum and baseline as fixed effects, and site as random effect|Difference in LS Means of changes from baseline to week 16 (Octagam - Placebo)|LS Means difference between changes from baseline to week 16||12.8|4.4|0.0001
72486000|NCT01159912|144499831|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.145||||0.011|TWO_SIDED|95.0|0.033|0.257|||ANCOVA|||||0.257|0.033|0.011
72486001|NCT00074581|144499861|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.07|||<|0.0001|TWO_SIDED|95.0|0.02|0.22|||Regression, Cox||The hazard ratio estimate presented (0.07) is a comparison of the early-ART arm (numerator) to the delayed-ART arm (denominator), thus indicating a 93% lower risk of infection among all linked partner infections, during the entire study.|||0.22|0.02|<0.0001
72486002|NCT00074581|144499862|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.31|||<|0.0001|TWO_SIDED|95.0|0.19|0.53|||Regression, Cox||The hazard ratio estimate presented (0.31) is a comparison of the early-ART arm (numerator) to the delayed-ART arm (denominator), thus indicating a 69% lower risk of infection among all partner infections, during the entire study.|||0.53|0.19|<0.0001
72402713|NCT01480076|144311691|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 3, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the total ALS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
72402714|NCT01480076|144311691|SUPERIORITY_OR_OTHER|||||||0.4243|||||||mixed effect model|||Month 3, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the total ALS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.4243
72402715|NCT01480076|144311691|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 3, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the total ALS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
72402716|NCT01480076|144311691|SUPERIORITY_OR_OTHER|||||||0.9989|||||||mixed effect model|||Month 3, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the total ALS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.9989
72402717|NCT01480076|144311691|SUPERIORITY_OR_OTHER||difference of LS means|-1.6|STANDARD_ERROR_OF_MEAN|0.68||0.0207|TWO_SIDED||||||mixed effect model|||Month 3, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the total ALS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0207
72486003|NCT00705432|144499887|SUPERIORITY_OR_OTHER||The difference in SVR|26.6|||<|0.0001|TWO_SIDED|95.0|19.1|34.1|||Cochran-Mantel Haenszel Chi-square test|Adjustments were made for for baseline stratification factors: viral load (\>400,000 vs. ≤400,000 IU/mL) and Genotype (1a vs 1b).||||34.1|19.1|<0.0001
72486004|NCT00705432|144499887|SUPERIORITY_OR_OTHER||The difference in SVR|28.3|||<|0.0001|TWO_SIDED|95.0|20.8|35.8|||Cochran-Mantel Haenszel Chi-square test|Adjustments were made for baseline stratification factors: viral load (\>400,000 vs. ≤400,000 IU/mL) and Genotype (1a vs 1b).||||35.8|20.8|<0.0001
72486005|NCT00705432|144499887|SUPERIORITY_OR_OTHER||The difference in SVR|19.2||||0.044|TWO_SIDED|95.0|1.6|36.9|||Cochran-Mantel Haenszel Chi-square test|Adjustments were made for the baseline stratification factors: viral load (\>400,000 vs. ≤400,000 IU/mL) and Genotype (1a vs 1b).||||36.9|1.6|0.0440
72486006|NCT00705432|144499887|SUPERIORITY_OR_OTHER||The difference in SVR|29.7||||0.0035|TWO_SIDED|95.0|12.2|47.1|||Cochran-Mantel Haenszel Chi-square|Adjustments were made for the baseline stratification factors: viral load (\>400,000 vs. ≤400,000 IU/mL) and Genotype (1a vs 1b).||||47.1|12.2|0.0035
72513095|NCT04047121|144556337|SUPERIORITY||Odds Ratio (OR)|-0.3527||||0.8603|TWO_SIDED|95.0|-4.279|3.5737|||Regression, Linear|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||3.5737|-4.2790|0.8603
72513096|NCT04047121|144556338|SUPERIORITY|||||||0.6344|||||||t-test, 2 sided|||||||0.6344
72513097|NCT04047121|144556338|SUPERIORITY|||||||0.3037|||||||t-test, 2 sided|||||||0.3037
72513098|NCT04047121|144556338|SUPERIORITY|||||||0.1344|||||||t-test, 2 sided|||||||0.1344
72513099|NCT04047121|144556338|SUPERIORITY||Odds Ratio (OR)|1.2586||||0.5092|TWO_SIDED|95.0|-2.4787|4.9958|||Regression, Linear|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||4.9958|-2.4787|0.5092
72486007|NCT00705432|144499888|SUPERIORITY_OR_OTHER||The difference in SVR rates|27.5|||<|0.0001|TWO_SIDED|95.0|19.2|35.2|||Cochran-Mantel Haenszel Chi-square|Adjustments were made for the baseline stratification factors: viral load (\>400,000 vs. ≤400,000 IU/mL) and Genotype (1a vs 1b).||||35.2|19.2|<0.0001
72486008|NCT00705432|144499888|SUPERIORITY_OR_OTHER||The difference in SVR rates|29.1|||<|0.0001|TWO_SIDED|95.0|21.5|36.8|||Cochran-Mantel Haenszel Chi-square|Adjustments were made for the baseline stratification factors: viral load (\>400,000 vs. ≤400,000 IU/mL) and Genotype (1a vs 1b).||||36.8|21.5|<0.0001
72513100|NCT04047121|144556338|SUPERIORITY||Odds Ratio (OR)|-0.7696||||0.8047|TWO_SIDED|95.0|-6.8683|5.3292|||Regression, Linear|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||5.3292|-6.8683|0.8047
72513101|NCT04047121|144556338|SUPERIORITY||Odds Ratio (OR)|0.094||||0.9757|TWO_SIDED|95.0|-5.9628|6.1507|||Regression, Linear|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||6.1507|-5.9628|0.9757
72513102|NCT04047121|144556339|SUPERIORITY|||||||0.0839|||||||t-test, 2 sided|||||||0.0839
72513103|NCT04047121|144556339|SUPERIORITY|||||||0.9577|||||||t-test, 2 sided|||||||0.9577
72513104|NCT04047121|144556339|SUPERIORITY|||||||0.9497|||||||t-test, 2 sided|||||||0.9497
72513105|NCT04047121|144556339|SUPERIORITY||Odds Ratio (OR)|-0.031||||0.4873|TWO_SIDED|95.0|-0.1185|0.0565|||Regression, Linear|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||0.0565|-0.1185|0.4873
72513106|NCT04047121|144556339|SUPERIORITY||Odds Ratio (OR)|-0.0312||||0.678|TWO_SIDED|95.0|-0.1783|0.1159|||Regression, Linear|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||0.1159|-0.1783|0.6780
72486009|NCT00705432|144499888|SUPERIORITY_OR_OTHER||The difference in SVR|21.3||||0.0366|TWO_SIDED|95.0|2.3|40.2|||Cochran-Mantel Haenszel Chi-square test|Adjustments were made for the baseline stratification factors: viral load (\>400,000 vs. ≤400,000 IU/mL) and Genotype (1a vs 1b).||||40.2|2.3|0.0366
72486010|NCT00705432|144499888|SUPERIORITY_OR_OTHER||The difference in SVR|27.2||||0.0107|TWO_SIDED|95.0|9.0|45.3|||Cochran-Mantel Haenszel Chi-square|Adjustments were made for the baseline stratification factors: viral load (\>400,000 vs. ≤400,000 IU/mL) and Genotype (1a vs 1b).||||45.3|9.0|0.0107
72486011|NCT01034540|144499897|SUPERIORITY_OR_OTHER_LEGACY|||||||0.959||||||Values were not normally distributed, thus analyses were performed on ranked values and medians (IQL) are presented.|ANOVA|All tests of statistical significance were completed at the 5% level, two-tailed (p\<0.05).||An evaluable sample of 19 subjects provided 80% power (5% alpha-level, 2-tailed) to detect a 2.1 unit difference between control and active in MISI, assuming a 3.0 unit standard deviation (SD). Repeated measures ANOVA was used to assess responses to treatment. Initial repeated measures models contained terms of treatment period, and sequence as fixed effects, with subject modeled as random effect; models were reduced until only significant terms or treatment remained.||||0.959
72486012|NCT01034540|144499898|SUPERIORITY_OR_OTHER_LEGACY|||||||0.037|||||||ANOVA|All tests of statistical significance were completed at the 5% level, two-tailed (p\<0.05).||||||0.037
72486013|NCT01034540|144499898|SUPERIORITY_OR_OTHER_LEGACY|||||||0.073||||||All tests of statistical significance were completed at the 5% level, two-tailed (p\<0.05).|ANOVA|||||||0.073
72486014|NCT00713817|144499965|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|0.89||||0.273|TWO_SIDED|95.0|-0.78|2.56|||ANCOVA|||The two groups were compared using Analysis of Covariance (ANCOVA) with baseline severity as a covariate and study centre group and treatment group as factors. Due to the low power of the test for interaction the test was performed at the 10% level of significance and a 95% confidence interval (CI) was presented for the difference between treatments.||2.56|-0.78|0.273
72486015|NCT00713817|144499966|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|4.62||||0.296|TWO_SIDED|95.0|-4.51|13.75|||ANCOVA|||The two groups were compared using Analysis of Covariance (ANCOVA) with baseline severity as a covariate and study centre group and treatment group as factors. Due to the low power of the test for interaction the test was performed at the 10% level of significance and a 95% confidence interval (CI) was presented for the difference between treatments.||13.75|-4.51|0.296
72486016|NCT00713817|144499967|SUPERIORITY_OR_OTHER_LEGACY||Chi-square|0.048||||0.826||95.0|||||Log Rank|||Time to treatment failure was analysed using Kaplan-Meier Survival analysis methodology. The difference in loss of response cumulative distribution function between treatments was assessed using the Hodges-Lehmann estimate.||||0.826
72486017|NCT00713817|144499968|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-7.14||||0.54|TWO_SIDED|95.0|-39.7|9.62|||Hodges-Lehmann|||The difference in loss of response cumulative distribution functions between treatments was assessed using the Wilcoxon test with an estimate of the median difference between groups in response level (percent change from baseline) provided by the Hodges-Lehmann estimator.||9.62|-39.7|0.54
72486018|NCT00713817|144499969|SUPERIORITY_OR_OTHER_LEGACY||Estimate mean treatment difference|-0.08||||0.902|TWO_SIDED|95.0|-1.45|1.29|||ANCOVA|||The two groups were compared using Analysis of Covariance (ANCOVA) with baseline severity as a covariate and study centre group and treatment group as factors. Due to the low power of the test for interaction the test was performed at the 10% level of significance and a 95% confidence interval (CI) was presented for the difference between treatments.||1.29|-1.45|0.902
72513107|NCT04047121|144556339|SUPERIORITY||Odds Ratio (OR)|0.0099||||0.9327|TWO_SIDED|95.0|-0.2207|0.2406|||Regression, Linear|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||0.2406|-0.2207|0.9327
72513108|NCT04047121|144556340|SUPERIORITY|||||||0.0021|||||||t-test, 2 sided|||||||0.0021
72567727|NCT02728752|144667036|SUPERIORITY||Median Difference (Net)|-0.4||||0.0002|TWO_SIDED|95.0|-0.5|-0.2|||ANCOVA|With treatment, stratum and baseline as fixed effects, and site as random effect|Difference in LS Means of changes from baseline to week 16 (Octagam - Placebo)|LS Means difference between changes from baseline to week 16||-0.2|-0.5|0.0002
72486019|NCT00713817|144499970|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.557||||0.603|TWO_SIDED|95.0|0.293|8.261|||Regression, Logistic|||The two treatment groups were compared using ordinal logistic regression and the proportional odds model. The model incorporated the parent Randomised Controlled Trials (RCTs). The interaction between treatment group and parent RCTs was investigated, but was dropped from the model if found to have little influence. The test was performed at the 10% significance level. The final model was then treatment group and parent RCTs, i.e. the treatment effect was adjusted for parent RCTs baseline.||8.261|0.293|0.603
72513109|NCT04047121|144556340|SUPERIORITY|||||||0.5396|||||||t-test, 2 sided|||||||0.5396
72513110|NCT04047121|144556340|SUPERIORITY|||||||0.6121|||||||t-test, 2 sided|||||||0.6121
72567728|NCT02728752|144667042|SUPERIORITY||Median Difference (Net)|-1.2||||0.001|TWO_SIDED|95.0|-1.9|-0.5|||ANCOVA|With treatment, stratum and baseline as fixed effects, and site as random effect|Difference in LS Means of changes from baseline to week 16 (Octagam - Placebo)|LS Means difference between changes from baseline to week 16||-0.5|-1.9|0.0010
72567729|NCT02025751|144667046|SUPERIORITY|||||||0.597|||||||ANCOVA|||||||0.597
72486020|NCT01540825|144500013|SUPERIORITY_OR_OTHER||Slope|1.2472|STANDARD_ERROR_OF_MEAN|0.032|||TWO_SIDED|95.0|1.1831|1.3112|||||Dose proportionality was explored using the power model (ANCOVA). The perfect dose proportionality would correspond to a slope β of 1. PK endpoints on the log-transformed scale. Standard Error of the mean is actually the Standard Error of the slope|This was non confirmatory testing (Single dose). Dose proportionality of BI 113608 (powder in bottle (PIB)) for Cmax was analysed.||1.3112|1.1831|
72513111|NCT04047121|144556340|SUPERIORITY||Odds Ratio (OR)|-0.1895||||0.0303|TWO_SIDED|95.0|-0.361|-0.0181|||Regression, Linear|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||-0.0181|-0.3610|0.0303
72513112|NCT04047121|144556340|SUPERIORITY||Odds Ratio (OR)|-0.1901||||0.1807|TWO_SIDED|95.0|-0.4685|0.0883|||Regression, Linear|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||0.0883|-0.4685|0.1807
72402718|NCT01480076|144311691|SUPERIORITY_OR_OTHER||difference of LS means|-2.9|STANDARD_ERROR_OF_MEAN|1.18||0.0161|TWO_SIDED||||||mixed effect model|||Month 3, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the total ALS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0161
72402719|NCT01480076|144311691|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 6, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the total ALS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
72402720|NCT01480076|144311691|SUPERIORITY_OR_OTHER|||||||0.4256|||||||mixed effect model|||Month 6, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the total ALS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.4256
72402721|NCT01480076|144311691|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 6, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the total ALS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
72567730|NCT00532935|144667053|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.47|STANDARD_DEVIATION|1.1|<|0.001|TWO_SIDED|95.0|-0.66|-0.28|||ANCOVA|ANCOVA model included a term for treatment and a covariate for the baseline A1C value.||||-0.28|-0.66|<0.001
72567731|NCT00532935|144667054|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-27.6|STANDARD_DEVIATION|29.1|<|0.001|TWO_SIDED|95.0|-32.7|-22.4|||ANCOVA|ANCOVA model included a term for treatment and a covariate for the baseline FPG value.||||-22.4|-32.7|<0.001
72402722|NCT01480076|144311691|SUPERIORITY_OR_OTHER|||||||0.3313|||||||mixed effect model|||Month 6, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the total ALS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.3313
72486021|NCT01540825|144500015|SUPERIORITY_OR_OTHER||Slope|1.1626|STANDARD_ERROR_OF_MEAN|0.0215|||TWO_SIDED|95.0|1.1195|1.2057|||||Dose proportionality was explored using the power model (ANCOVA). The perfect dose proportionality would correspond to a slope β of 1. PK endpoints on the log-transformed scale. Standard Error of the mean is actually Standard Error of the slope|This was non confirmatory testing (Single dose). Dose proportionality of BI 113608 (PIB) for AUC 0- tz was analysed.||1.2057|1.1195|
72486022|NCT01540825|144500016|SUPERIORITY_OR_OTHER||Slope|1.151|STANDARD_ERROR_OF_MEAN|0.0215|||TWO_SIDED|95.0|1.108|1.1941|||||Dose proportionality was explored using the power model (ANCOVA). The perfect dose proportionality would correspond to a slope β of 1. PK endpoints on the log-transformed scale. Standard Error of the mean is actually Standard Error of the slope|This was non confirmatory testing (Single dose).Dose proportionality of BI 113608 (PIB) for AUC0-inf was analysed||1.1941|1.1080|
72486023|NCT01641237|144500022|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANOVA|Adjusted Mean and SE were calculated from ANOVA model with treatment and period as factors, and subject as a random factor.||Test for linear dose-response relationship was performed for %SMHR as a function of fluoride concentration.||||<0.0001
72486024|NCT01641237|144500022|SUPERIORITY_OR_OTHER|||||||0.3748||95.0|||||ANOVA|Adjusted Mean and SE were calculated from ANOVA model with treatment and period as factors, and subject as a random factor.||Test for quadratic dose-response relationship was performed for %SMHR as a function of fluoride concentration.||||0.3748
72486025|NCT01641237|144500023|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|2.17||||0.1898|TWO_SIDED|95.0|-1.09|5.43||No adjustment was required for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with fixed factors for study period and treatment and the subject as random effect.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered treatments in comparison to be equal.||5.43|-1.09|0.1898
72486026|NCT01641237|144500023|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|5.6||||0.0009|TWO_SIDED|95.0|2.35|8.86||No adjustment was required for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with fixed factors for study period and treatment and the subject as random effect.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered no dose-response relationship between %SMHR and fluoride concentration in the dentifrice.||8.86|2.35|0.0009
72486027|NCT01641237|144500023|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|3.43||||0.0389|TWO_SIDED|95.0|0.18|6.68||No adjustment was required for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with fixed factors for study period and treatment and the subject as random effect.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered treatments in comparison to be equal.||6.68|0.18|0.0389
72486028|NCT01641237|144500023|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|9.86|||<|0.0001|TWO_SIDED|95.0|6.58|13.13||No adjustment was required for multiple comparisons as primary comparison was pre-specified.|ANOVA|ANOVA with fixed factors for study period and treatment, and subject as random effect.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered treatments in comparison to be equal.||13.13|6.58|<0.0001
72486029|NCT01641237|144500023|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|7.68|||<|0.0001|TWO_SIDED|95.0|4.41|10.96||No adjustment was required for multiple comparisons as primary comparison was pre-specified.|ANOVA|ANOVA with fixed factors for study period and treatment, and subject as random effect.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered treatments in comparison to be equal.||10.96|4.41|<0.0001
72486030|NCT01641237|144500023|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|4.25||||0.0112|TWO_SIDED|95.0|0.98|7.53||No adjustment was required for multiple comparisons as primary comparison was pre-specified.|ANOVA|ANOVA with fixed factors for study period and treatment, and subject as random effect.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered treatments in comparison to be equal.||7.53|0.98|0.0112
72402723|NCT01480076|144311691|SUPERIORITY_OR_OTHER||difference of LS means|-1.9|STANDARD_ERROR_OF_MEAN|0.83||0.0238|TWO_SIDED||||||mixed effect model|||Month 6, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the total ALS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0238
72486031|NCT01641237|144500024|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANOVA|Adjusted Mean and SE were calculated from ANOVA model with treatment and period as factors, and subject as a random factor.||Test for linear dose-response relationship was performed for %RER as a function of fluoride concentration.||||<0.0001
72486032|NCT01641237|144500024|SUPERIORITY_OR_OTHER|||||||0.0002||95.0|||||ANOVA|||Test for quadratic dose-response relationship was performed for %RER as a function of fluoride concentration.||||0.0002
72486033|NCT01641237|144500024|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|32.38|||<|0.0001|TWO_SIDED|95.0|25.18|39.59||No adjustment was required for multiple comparisons as primary comparison was pre-specified.|ANOVA|ANOVA with fixed factors for study period and treatment, while subject was random effect.|Difference was first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered no difference between treatments, being compared.||39.59|25.18|<0.0001
72486034|NCT01641237|144500024|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|31.46|||<|0.0001|TWO_SIDED|95.0|24.25|38.67||No adjustment was required for multiple comparisons as primary comparison was pre-specified.|ANOVA|ANOVA with fixed factors for study period and treatment, while subject was random effect.|Difference was first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered no difference between treatments, being compared.||38.67|24.25|<0.0001
72486035|NCT01641237|144500024|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|20.81|||<|0.0001|TWO_SIDED|95.0|13.6|28.02||No adjustment was required for multiple comparisons as primary comparison was pre-specified.|ANOVA|ANOVA with fixed factors for study period and treatment, while subject was random effect.|Difference was first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered no difference between treatments, being compared.||28.02|13.60|<0.0001
72486036|NCT01641237|144500024|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.92||||0.8|TWO_SIDED|95.0|-6.25|8.1||No adjustment was required for multiple comparisons as primary comparison was pre-specified.|ANOVA|ANOVA with fixed factors for study period and treatment, while subject was random effect.|Difference was first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered no difference between treatments, being compared.||8.10|-6.25|0.8000
72486037|NCT01641237|144500024|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|11.57||||0.0017|TWO_SIDED|95.0|4.4|18.74||No adjustment was required for multiple comparisons as primary comparison was pre-specified.|ANOVA|ANOVA with fixed factors for study period and treatment, while subject was random effect.|Difference was first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered no difference between treatments, being compared.||18.74|4.40|0.0017
72486038|NCT01641237|144500024|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|10.65||||0.0038|TWO_SIDED|95.0|3.48|17.81||No adjustment was required for multiple comparisons as primary comparison was pre-specified.|ANOVA|ANOVA with fixed factors for study period and treatment, while subject was random effect.|Difference was first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered no difference between treatments, being compared.||17.81|3.48|0.0038
72513113|NCT04047121|144556340|SUPERIORITY||Odds Ratio (OR)|0.1594||||0.7445|TWO_SIDED|95.0|-0.7991|1.1178|||Regression, Linear|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||1.1178|-0.7991|0.7445
72486039|NCT01641237|144500025|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANOVA|Adjusted Mean and SE were calculated from ANOVA model with treatment and period as factors, and subject as a random factor.||Test for linear dose-response relationship was performed for EFU as a function of fluoride concentration.||||<0.0001
72486040|NCT01641237|144500025|SUPERIORITY_OR_OTHER|||||||0.0008||95.0|||||ANOVA|Adjusted Mean and SE were calculated from ANOVA model with treatment and period as factors, and subject as a random factor.||Test for quadratic dose-response relationship was performed for EFU as a function of fluoride concentration.||||0.0008
72513114|NCT04047121|144556341|SUPERIORITY|||||||0.0035|||||||t-test, 2 sided|||||||0.0035
72513115|NCT04047121|144556341|SUPERIORITY|||||||0.504|||||||t-test, 2 sided|||||||0.5040
72513116|NCT04047121|144556341|SUPERIORITY|||||||0.1366|||||||t-test, 2 sided|||||||0.1366
72567732|NCT00532935|144667055|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-20.2|STANDARD_DEVIATION|59.7|<|0.001|TWO_SIDED|95.0|-32.1|-8.3|||ANCOVA|ANCOVA model included a term for treatment and a covariate for the baseline 2-hour PMG value.||||-8.3|-32.1|<0.001
72567733|NCT00532935|144667056|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-11.9|STANDARD_DEVIATION|40.3|<|0.001|TWO_SIDED|95.0|-19.0|-4.9|||ANCOVA|ANCOVA model included a term for treatment and a covariate for the baseline FPG value.||||-4.9|-19.0|<0.001
72567734|NCT00532935|144667057|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.0|||<|0.001|TWO_SIDED|95.0|1.3|2.8||Based on a test of the odds ratio = 1, comparing the odds of having A1C \<7.0% at Week 32 in the Sitagliptin/Metformin 50/1000 mg b.i.d. group vs. the Pioglitazone 45 mg q.d. group.|Regression, Logistic|logistic regression model included a term for treatment and a covariate for the baseline A1C value.|This parameter estimate and 95% confidence interval correspond to the odds of having A1C \<7.0% at Week 32 in the Sitagliptin/Metformin 50/1000 mg b.i.d. group vs. the Pioglitazone 45 mg q.d. group.|||2.8|1.3|<0.001
72576926|NCT00261443|144680717|SUPERIORITY_OR_OTHER_LEGACY|||||||0.928||95.0||||CMH General Association Test controlling for mood stabilizer.|Cochran-Mantel-Haenszel|||Week 52 Treatment Comparison||||0.928
72402724|NCT01480076|144311691|SUPERIORITY_OR_OTHER||difference of LS means|-3.4|STANDARD_ERROR_OF_MEAN|1.39||0.015|TWO_SIDED||||||mixed effect model|||Month 6, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the total ALS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0150
72402725|NCT01480076|144311691|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 9, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the total ALS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
72402726|NCT01480076|144311691|SUPERIORITY_OR_OTHER|||||||0.0171|||||||mixed effect model|||Month 9, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the total ALS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0171
72402727|NCT01480076|144311691|SUPERIORITY_OR_OTHER|||||||0.0007|||||||mixed effect model|||Month 9, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the total ALS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0007
72402728|NCT01480076|144311691|SUPERIORITY_OR_OTHER|||||||0.5146|||||||mixed effect model|||Month 9, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the total ALS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.5146
72486041|NCT01641237|144500025|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|1.66|||<|0.0001|TWO_SIDED|95.0|1.42|1.9||No adjustment was required for multiple comparisons as primary comparison was pre-specified.|ANOVA|ANOVA with fixed factors for study period and treatment, while subject was random effect.|Difference was first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered no difference between treatments, being compared.||1.90|1.42|<0.0001
72402729|NCT01480076|144311691|SUPERIORITY_OR_OTHER||difference of LS means|-3.0|STANDARD_ERROR_OF_MEAN|0.84||0.0003|TWO_SIDED||||||mixed effect model|||Month 9, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the total ALS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0003
72486042|NCT01641237|144500025|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|1.6|||<|0.0001|TWO_SIDED|95.0|1.36|1.85||No adjustment was required for multiple comparisons as primary comparison was pre-specified.|ANOVA|ANOVA with fixed factors for study period and treatment, while subject was random effect.|Difference was first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered no difference between treatments, being compared.||1.85|1.36|<0.0001
72513117|NCT04047121|144556341|SUPERIORITY||Odds Ratio (OR)|-3.4084||||0.082|TWO_SIDED|95.0|-7.2497|0.433|||Regression, Linear|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||0.4330|-7.2497|0.0820
72402730|NCT01480076|144311691|SUPERIORITY_OR_OTHER||difference of LS means|-2.7|STANDARD_ERROR_OF_MEAN|1.72||0.1224|TWO_SIDED||||||mixed effect model|||Month 9, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the total ALS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.1224
72402731|NCT01480076|144311691|SUPERIORITY_OR_OTHER|||||||0.0168|||||||mixed effect model|||Month 12, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the total ALS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0168
72402732|NCT01480076|144311691|SUPERIORITY_OR_OTHER|||||||0.2272|||||||mixed effect model|||Month 12, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the total ALS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.2272
72513118|NCT04047121|144556341|SUPERIORITY||Odds Ratio (OR)|-1.5342||||0.5845|TWO_SIDED|95.0|-7.0336|3.9652|||Regression, Linear|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||3.9652|-7.0336|0.5845
72513119|NCT04047121|144556341|SUPERIORITY||Odds Ratio (OR)|0.987||||0.7284|TWO_SIDED|95.0|-4.583|6.557|||Regression, Linear|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||6.5570|-4.5830|0.7284
72513120|NCT04047121|144556342|SUPERIORITY|||||||0.1125|||||||t-test, 2 sided|||||||0.1125
72513121|NCT04047121|144556342|SUPERIORITY|||||||0.7156|||||||t-test, 2 sided|||||||0.7156
72513122|NCT04047121|144556342|SUPERIORITY|||||||0.2056|||||||t-test, 2 sided|||||||0.2056
72576927|NCT00261443|144680717|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|1.17||||0.584|TWO_SIDED|95.0|0.66|2.09||CMH General Association Test controlling for mood stabilizer.|Cochran-Mantel-Haenszel|||Week 52 (LOCF) Treatment Comparison||2.09|0.66|0.584
72513123|NCT04047121|144556342|SUPERIORITY||Odds Ratio (OR)|-1.8061||||0.4288|TWO_SIDED|95.0|-6.2797|2.6675|||Regression, Linear|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||2.6675|-6.2797|0.4288
72513124|NCT04047121|144556342|SUPERIORITY||Odds Ratio (OR)|-1.6946||||0.6303|TWO_SIDED|95.0|-8.5962|5.2069|||Regression, Linear|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||5.2069|-8.5962|0.6303
72513125|NCT04047121|144556342|SUPERIORITY||Odds Ratio (OR)|-0.9873||||0.7477|TWO_SIDED|95.0|-7.0028|5.0281|||Regression, Linear|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||5.0281|-7.0028|0.7477
72513126|NCT04047121|144556343|SUPERIORITY|||||||0.3919|||||||t-test, 2 sided|||||||0.3919
72513127|NCT04047121|144556343|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
72513128|NCT04047121|144556343|SUPERIORITY|||||||0.0193|||||||t-test, 2 sided|||||||0.0193
72513129|NCT04047121|144556343|SUPERIORITY||Cost Ratio|1.2232||||0.057|TWO_SIDED|95.0|0.994|1.5053|||Regression, Linear||Since health care costs were skewed, hence estimated cost was modeled using a generalized linear model (GLM). Coefficients from a generalized linear model were estimated as cost ratios.|To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||1.5053|0.9940|0.0570
72513130|NCT04047121|144556343|SUPERIORITY||Cost Ratio|1.8479|||<|0.0001|TWO_SIDED|95.0|1.4378|2.3749|||Regression, Linear||Since health care costs were skewed, hence estimated cost was modeled using a GLM. Coefficients from a generalized linear model were estimated as cost ratios.|To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||2.3749|1.4378|<0.0001
72513131|NCT04047121|144556343|SUPERIORITY||Cost Ratio|1.1868||||0.0924|TWO_SIDED|95.0|0.9722|1.4487|||Regression, Linear||Since health care costs were skewed, hence estimated cost was modeled using a GLM. Coefficients from a generalized linear model were estimated as cost ratios.|To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||1.4487|0.9722|0.0924
72513132|NCT04047121|144556344|SUPERIORITY|||||||0.6184|||||||t-test, 2 sided|||||||0.6184
72567735|NCT01663727|144667063|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.68||||0.0007|TWO_SIDED|99.0|0.51|0.91|||Log Rank||Hazards ratio was estimated by Cox regression.|Stratified analysis: Stratification factors were plasma VEGF-A level (low/high), prior adjuvant chemotherapy (yes/no) and estrogen receptor / progesterone receptor status (positive, negative).||0.91|0.51|0.0007
72513133|NCT04047121|144556344|SUPERIORITY|||||||0.1952|||||||t-test, 2 sided|||||||0.1952
72513134|NCT04047121|144556344|SUPERIORITY|||||||0.1638|||||||t-test, 2 sided|||||||0.1638
72513135|NCT04047121|144556344|SUPERIORITY||Cost Ratio|0.9773||||0.6732|TWO_SIDED|95.0|0.8782|1.0875|||Regression, Linear||Since health care costs were skewed, hence estimated cost was modeled using a GLM. Coefficients from a generalized linear model were estimated as cost ratios.|To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||1.0875|0.8782|0.6732
72513136|NCT04047121|144556344|SUPERIORITY||Cost Ratio|0.9629||||0.6345|TWO_SIDED|95.0|0.824|1.1253|||Regression, Linear||Since health care costs were skewed, hence estimated cost was modeled using a GLM. Coefficients from a generalized linear model were estimated as cost ratios.|To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||1.1253|0.8240|0.6345
72513137|NCT04047121|144556344|SUPERIORITY||Cost Ratio|0.8327||||0.0029|TWO_SIDED|95.0|0.738|0.9395|||Regression, Linear||Since health care costs were skewed, hence estimated cost was modeled using a GLM. Coefficients from a generalized linear model were estimated as cost ratios.|To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||0.9395|0.7380|0.0029
72513138|NCT04047121|144556345|SUPERIORITY|||||||0.3087|||||||t-test, 2 sided|||||||0.3087
72513139|NCT04047121|144556345|SUPERIORITY|||||||0.0003|||||||t-test, 2 sided|||||||0.0003
72513140|NCT04047121|144556345|SUPERIORITY|||||||0.0647|||||||t-test, 2 sided|||||||0.0647
72567736|NCT01663727|144667063|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.73||||0.0046|TWO_SIDED|99.0|0.55|0.97|||Log Rank|||Unstratified Analysis.||0.97|0.55|0.0046
72513141|NCT04047121|144556345|SUPERIORITY||Cost Ratio|0.9762||||0.7684|TWO_SIDED|95.0|0.8316|1.146|||Regression, Linear||Since health care costs were skewed, hence estimated cost was modeled using a GLM. Coefficients from a generalized linear model were estimated as cost ratios.|To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||1.1460|0.8316|0.7684
72513142|NCT04047121|144556345|SUPERIORITY||Cost Ratio|1.3862||||0.0012|TWO_SIDED|95.0|1.1379|1.6886|||Regression, Linear||Since health care costs were skewed, hence estimated cost was modeled using a GLM. Coefficients from a generalized linear model were estimated as cost ratios.|To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||1.6886|1.1379|0.0012
72513143|NCT04047121|144556345|SUPERIORITY||Cost Ratio|1.0065||||0.9422|TWO_SIDED|95.0|0.8452|1.1985|||Regression, Linear||Since health care costs were skewed, hence estimated cost was modeled using a GLM. Coefficients from a generalized linear model were estimated as cost ratios.|To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||1.1985|0.8452|0.9422
72402733|NCT01480076|144311691|SUPERIORITY_OR_OTHER|||||||0.057|||||||mixed effect model|||Month 12, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the total ALS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0570
72402734|NCT01480076|144311691|SUPERIORITY_OR_OTHER|||||||0.5832|||||||mixed effect model|||Month 12, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the total ALS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.5832
72402735|NCT01480076|144311691|SUPERIORITY_OR_OTHER||difference of LS means|-1.8|STANDARD_ERROR_OF_MEAN|0.94||0.0561|TWO_SIDED||||||mixed effect model|||Month 12, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the total ALS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0561
72402736|NCT01480076|144311691|SUPERIORITY_OR_OTHER||difference of LS means|-1.9|STANDARD_ERROR_OF_MEAN|1.86||0.2971|TWO_SIDED||||||mixed effect model|||Month 12, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the total ALS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.2971
72402737|NCT01480076|144311692|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Overall, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
72402738|NCT01480076|144311692|SUPERIORITY_OR_OTHER|||||||0.0029|||||||mixed effect model|||Overall, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0029
72486043|NCT01641237|144500025|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.62|||<|0.0001|TWO_SIDED|95.0|0.38|0.86||No adjustment was required for multiple comparisons as primary comparison was pre-specified.|ANOVA|ANOVA with fixed factors for study period and treatment, while subject was random effect.|Difference was first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered no difference between treatments, being compared.||0.86|0.38|<0.0001
72486044|NCT01641237|144500025|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.05||||0.668|TWO_SIDED|95.0|-0.19|0.29||No adjustment was required for multiple comparisons as primary comparison was pre-specified.|ANOVA|ANOVA with fixed factors for study period and treatment, while subject was random effect.|Difference was first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered no difference between treatments, being compared.||0.29|-0.19|0.6680
72513144|NCT04047121|144556346|SUPERIORITY|||||||0.0421|||||||t-test, 2 sided|||||||0.0421
72513145|NCT04047121|144556346|SUPERIORITY|||||||0.8137|||||||t-test, 2 sided|||||||0.8137
72513146|NCT04047121|144556346|SUPERIORITY|||||||0.9416|||||||t-test, 2 sided|||||||0.9416
72513147|NCT04047121|144556346|SUPERIORITY||Cost Ratio|0.9515||||0.319|TWO_SIDED|95.0|0.8628|1.0493|||Regression, Linear||Since health care costs were skewed, hence estimated cost was modeled using a GLM. Coefficients from a generalized linear model were estimated as cost ratios.|To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||1.0493|0.8628|0.3190
72513148|NCT04047121|144556346|SUPERIORITY||Cost Ratio|0.8991||||0.1368|TWO_SIDED|95.0|0.7815|1.0343|||Regression, Linear||Since health care costs were skewed, hence estimated cost was modeled using a GLM. Coefficients from a generalized linear model were estimated as cost ratios.|To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||1.0343|0.7815|0.1368
72513149|NCT04047121|144556346|SUPERIORITY||Cost Ratio|0.8514||||0.0231|TWO_SIDED|95.0|0.7411|0.9782|||Regression, Linear||Since health care costs were skewed, hence estimated cost was modeled using a GLM. Coefficients from a generalized linear model were estimated as cost ratios.|To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||0.9782|0.7411|0.0231
72513150|NCT00424528|144556364|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|Study baseline FEV1 as covariate and treatment group as fixed effect.||||||<0.001
72513151|NCT00424528|144556364|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|Study Baseline FEV1 as a covariate and treatment group as a fixed effect.||||||<0.001
72567737|NCT01663727|144667063|SUPERIORITY_OR_OTHER|||||||0.4619|TWO_SIDED||||||Wald Test|||A stratified multivariate Cox regression model, including treatment, VEGF-A level, and interaction between treatment and VEGF-A level (low, high) as factors was used to estimate the interaction p-value of the treatment with VEGF-A level for PFS. Analysis for the interaction of treatment effect with the plasma VEGF-A levels was a secondary objective.||||0.4619
72567738|NCT01663727|144667065|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.94||||0.5877|TWO_SIDED|95.0|0.75|1.18|||Log Rank||Hazards ratio was estimated by Cox regression.|Stratified analysis: Stratified analysis: Stratification factors were plasma VEGF-A level (low/high), prior adjuvant chemotherapy (yes/no) and estrogen receptor / progesterone receptor status (positive, negative).||1.18|0.75|0.5877
72486045|NCT01641237|144500025|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|1.04|||<|0.0001|TWO_SIDED|95.0|0.8|1.28||No adjustment was required for multiple comparisons as primary comparison was pre-specified.|ANOVA|ANOVA with fixed factors for study period and treatment, while subject was random effect.|Difference was first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered no difference between treatments, being compared.||1.28|0.80|<0.0001
72486046|NCT01641237|144500025|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.99|||<|0.0001|TWO_SIDED|95.0|0.75|1.23||No adjustment was required for multiple comparisons as primary comparison was pre-specified.|ANOVA|ANOVA with fixed factors for study period and treatment, while subject was random effect.|Difference was first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered no difference between treatments, being compared.||1.23|0.75|<0.0001
72486047|NCT05368961|144500028|OTHER|Null hypothesis; there is no difference in anxiety scores between usual care and distraction||||||0.44|||||||Wilcoxon (Mann-Whitney)|||||||0.44
72486048|NCT03593850|144500034|SUPERIORITY|||||||0.002|||||||t-test, 2 sided|||||||0.002
72486049|NCT03593850|144500035|EQUIVALENCE|Equivalence analysis was performed according to pre-defined significant difference of p \< 0.01||||||0.392|||||||t-test, 2 sided|||||||0.392
72486050|NCT03593850|144500036|EQUIVALENCE|Equivalence analysis was performed according to pre-defined significant difference of p \< 0.01||||||0.802|||||||t-test, 2 sided|||||||0.802
72486051|NCT03593850|144500037|SUPERIORITY|||||||0.01|||||||t-test, 2 sided|||||||0.01
72486052|NCT03593850|144500037|SUPERIORITY||Adjusted mean difference|1.429||||0.006|TWO_SIDED||||||ANCOVA|Fixed factors: group, covariates: pain before (VAS2), age in years, age at menarche, duration of menses, usual pain, anxiety before, hours with pain.|||Adjusted means: music 3.131 (99% CI 2.62, 3.999) and silence 4.56 (99% CI 3.581, 5.538), F= 8.44, R-square 54.5%|||0.006
72486053|NCT03593850|144500038|SUPERIORITY|||||||0.11|||||||t-test, 2 sided|||||||0.11
72486054|NCT03593850|144500038|SUPERIORITY||Adjusted mean difference|0.721||||0.37|TWO_SIDED||||||ANCOVA|Fixed factor: Groups Covariates: Pain before, pain after, age, age menarche, menses duration, usual pain, anxiety before, anxiety after, hours pain|Adjusted means: music 2.58 (99% CI 1.339, 3.829), and silence 3.305 (1.728, 4.881); F 0.827, R-square 27.2%|||||0.370
72486055|NCT03593850|144500039|EQUIVALENCE|Equivalence between groups was pre-defined as p \> 0.01||||||0.377|||||||t-test, 2 sided|||||||0.377
72486056|NCT03593850|144500040|SUPERIORITY|||||||0.049|||||||t-test, 2 sided|||||||0.049
72486057|NCT03593850|144500041|SUPERIORITY|||||||0.168|||||||t-test, 2 sided|||||||0.168
72513152|NCT00424528|144556364|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Primary analysis:Group 2 vs 3. Key secondary analysis: Group 1 vs 3. Multiple comparisons for the analysis of the primary endpoint were controlled at the 5% level.|ANCOVA|Study baseline FEV1 as a covariate and treatment group as fixed effect.||||||<0.001
72486058|NCT03593850|144500042|EQUIVALENCE|Equivalence between groups was pre-defined as p \> 0.01||||||0.642|||||||Chi-squared|||||||0.642
72486059|NCT03593850|144500043|SUPERIORITY|||||||0.02|||||||Chi-squared|||||||0.02
72513153|NCT00424528|144556365|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|Study baseline FEV1 as a covariate and treatment group as a fixed effect.||||||<0.001
72486060|NCT03593850|144500044|SUPERIORITY|||||||0.025|||||||Chi-squared|||||||0.025
72486061|NCT03593850|144500045|EQUIVALENCE|Equivalence between groups determined by pre-deined p \> 0.01||||||0.307|||||||t-test, 2 sided|||||||0.307
72486062|NCT03593850|144500046|EQUIVALENCE|Equivalence between groups determined by pre-deined p \> 0.01||||||0.318|||||||t-test, 2 sided|||||||0.318
72486063|NCT03593850|144500047|EQUIVALENCE|Equivalence between groups determined by pre-deined p \> 0.01||||||0.954|||||||t-test, 2 sided|||||||0.954
72486064|NCT03593850|144500048|EQUIVALENCE|Equivalence between groups determined by pre-deined p \> 0.01||||||0.258|||||||t-test, 2 sided|||||||0.258
72486065|NCT03593850|144500049|SUPERIORITY|||||||0.058|||||||t-test, 2 sided|||||||0.058
72486066|NCT03593850|144500050|SUPERIORITY|||||||0.056|||||||t-test, 2 sided|||||||0.056
72486067|NCT03593850|144500051|SUPERIORITY|||||||0.885|||||||t-test, 2 sided|||||||0.885
72486068|NCT03593850|144500052|SUPERIORITY|||||||0.036|||||||t-test, 2 sided|||||||0.036
72486069|NCT01735279|144500056|OTHER|Test t Student|Mean Difference (Final Values)|0.05|||<|0.05|TWO_SIDED||||||ANOVA|||||||<0.05
72486070|NCT01735279|144500056|SUPERIORITY||Mean Difference (Final Values)|30.84|||<|0.01|ONE_SIDED|95.0|||||ANOVA|||||||<0.01
72486071|NCT01735279|144500056|SUPERIORITY||Mean Difference (Final Values)|0.002|||<|0.01|TWO_SIDED||||||t-test, 1 sided|||||||<0.01
72486072|NCT01735279|144500056|SUPERIORITY||Mean Difference (Final Values)|4.4|||<|0.01|ONE_SIDED||||||t-test, 1 sided|||||||<0.01
72486073|NCT00119041|144500057|SUPERIORITY_OR_OTHER||||||>|0.153|TWO_SIDED|||||Threshold for statistical significance was p\<0.025 using Bonferroni correction for 2 statistical tests.|t-test, 2 sided|||Comparisons were made between the intervention and control groups at baseline||||>0.153
72486074|NCT00119041|144500057|SUPERIORITY_OR_OTHER||||||>|0.25|TWO_SIDED|||||Threshold for statistical significance was p\<0.025 using Bonferroni correction for 2 statistical tests.|t-test, 2 sided|Threshold for statistical significance was p\<0.025 using Bonferroni correction for 2 statistical tests.||Comparisons were made between the intervention and control groups at 18 months||||>0.25
72486075|NCT01195090|144500075|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.23|STANDARD_ERROR_OF_MEAN|0.16||0.165|TWO_SIDED|95.0|-0.58|0.08||The change from baseline in A1C were determined using an analysis of co-variance (ANCOVA) model with the factor 'treatment' and baseline A1C as covariate.|ANCOVA|||The change from baseline in A1C were determined using an analysis of co-variance (ANCOVA) model with the factor 'treatment' and baseline A1C as covariate.||0.08|-0.58|0.165
72486076|NCT01195090|144500091|NON_INFERIORITY_OR_EQUIVALENCE|Chi-square test|Chi-Square|0.0034||||0.954||||||Chi-square test|Chi-squared|||Chi-square test for percentages of patient achieving an A1C \<7%||||0.954
72486077|NCT05111041|144500104|SUPERIORITY||Odds Ratio (OR)|1.0||||1|TWO_SIDED|95.0|0.302|3.309||Not adjusted for multiple outcomes due to exploratory nature of the study.|Regression, Logistic|||||3.309|0.302|1.000
72486078|NCT05111041|144500105|SUPERIORITY||Odds Ratio (OR)|0.8||||0.7389|TWO_SIDED|95.0|0.215|2.972||Not adjusted for multiple outcomes due to exploratory nature of the study.|Regression, Logistic|||||2.972|0.215|0.7389
72513154|NCT00424528|144556365|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||ANCOVA|Study baseline FEV1 as a covariate and treatment group as a fixed effect.||||||0.001
72486079|NCT05111041|144500107|SUPERIORITY||Odds Ratio (OR)|1.306||||0.6058|TWO_SIDED|95.0|0.474|3.602||Not adjusted for multiple outcomes due to exploratory nature of the study.|Regression, Logistic|||||3.602|0.474|0.6058
72486080|NCT05111041|144500108|SUPERIORITY||Odds Ratio (OR)|1.0|||||TWO_SIDED|95.0|0.349|2.866||||||||2.866|0.349|
72486081|NCT05111041|144500109|SUPERIORITY||Odds Ratio (OR)|1.333||||0.5925|TWO_SIDED|95.0|0.465|3.823||Not adjusted for multiple outcomes due to exploratory nature of the study.|Regression, Logistic|||||3.823|0.465|0.5925
72513155|NCT00424528|144556366|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||ANCOVA|Study baseline FEV1 as a covariate and treatment group as a fixed effect.||||||0.001
72513156|NCT00424528|144556366|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|Study baseline FEV1 as a covariate and treatment group as a fixed effect.||||||<0.001
72513157|NCT00424528|144556367|SUPERIORITY_OR_OTHER|||||||0.073||95.0|||||ANCOVA|Study baseline FEV1 as a covariate and treatment group as a fixed effect.||||||0.073
72513158|NCT00424528|144556367|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|Study baseline FEV1 as a covariate and treatment group as a fixed effect.||||||0.050
72513159|NCT00424528|144556370|SUPERIORITY_OR_OTHER|||||||0.06||95.0|||||ANCOVA|Week 0 comparisons: Study baseline FEV1 as a covariate and treatment group as a fixed effect.||Week 0 comparisons||||0.060
72513160|NCT00424528|144556370|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|Study baseline FEV1 as a covariate and treatment group as a fixed effect.||Week 0||||<0.001
72402739|NCT01480076|144311692|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Overall, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
72486082|NCT01205230|144500110|SUPERIORITY_OR_OTHER||Ratio of least square geometric means|1.66|||||TWO_SIDED|90.0|1.39|1.99|||||Ratio of least square (LS) geometric means (Pazopanib + Ketoconozole : Pazopanib alone)|||1.99|1.39|
72513161|NCT00424528|144556370|SUPERIORITY_OR_OTHER|||||||0.004||95.0|||||ANCOVA|Week 2 comparisons: Study baseline FEV1 as a covariate and treatment group as a fixed effect.||Week 2 comparisons||||0.004
72486083|NCT01205230|144500110|SUPERIORITY_OR_OTHER||Ratio of LS geometric means|0.6|||||TWO_SIDED|90.0|0.52|0.7|||||Ratio of LS geometric means (Pazopanib + Esomeprazole : Pazopanib alone)|||0.70|0.52|
72486084|NCT01205230|144500111|SUPERIORITY_OR_OTHER||Ratio of LS geometric means|1.45|||||TWO_SIDED|90.0|1.14|1.86|||||Ratio of LS geometric means (Pazopanib + Ketoconozole : Pazopanib alone)|||1.86|1.14|
72486085|NCT01205230|144500111|SUPERIORITY_OR_OTHER||Ratio of LS geometric means|0.58|||||TWO_SIDED|90.0|0.5|0.67|||||Ratio of LS geometric means (Pazopanib + Esomeprazole : Pazopanib alone)|||0.67|0.50|
72513162|NCT00424528|144556370|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||ANCOVA|Week 2 comparisons: Study baseline FEV1 as a covariate and treatment group as a fixed effect.||Week 2 comparisons||||0.002
72513163|NCT00424528|144556373|SUPERIORITY_OR_OTHER|||||||0.206||95.0|||||ANCOVA|Study baseline Inspiratory Capacity as a covariate and treatment group as a fixed effect.||||||0.206
72513164|NCT00424528|144556373|SUPERIORITY_OR_OTHER|||||||0.025||95.0|||||ANCOVA|Study baseline Inspiratory Capacity as a covariate and treatment group as a fixed effect.||||||0.025
72513165|NCT01313520|144556384|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|||<|0.001|TWO_SIDED|95.0|-0.4|-0.1|||Constrained Longitudinal Data Analysis|||||-0.1|-0.4|<0.001
72567739|NCT01663727|144667065|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.97||||0.8004|TWO_SIDED|95.0|0.78|1.21|||Log Rank||Hazards ratio was estimated by Cox regression.|Unstratified analysis.||1.21|0.78|0.8004
72486086|NCT01205230|144500112|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.45|||||TWO_SIDED|90.0|-1.06|0.06||||||||0.06|-1.06|
72486087|NCT01205230|144500112|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.07|||||TWO_SIDED|90.0|-0.1|2.44||||||||2.44|-0.10|
72486088|NCT00791258|144500120|SUPERIORITY_OR_OTHER||Percentage|75.8|||||TWO_SIDED|95.0|73.0|78.5||||||||78.5|73.0|
72486089|NCT00791258|144500121|SUPERIORITY_OR_OTHER||Percentage|84.3|||||TWO_SIDED|95.0|81.8|86.5||||||||86.5|81.8|
72486090|NCT00791258|144500122|SUPERIORITY_OR_OTHER||Percentage|71.3|||||TWO_SIDED|95.0|68.3|74.1||||||12 week analysis||74.1|68.3|
72486091|NCT00791258|144500122|SUPERIORITY_OR_OTHER||Percentage|84.8|||||TWO_SIDED|95.0|82.4|87.0||||||20 week analysis||87.0|82.4|
72513166|NCT01313520|144556385|SUPERIORITY_OR_OTHER|||||||0.048||95.0|||||Fisher Exact|||||||0.048
72513167|NCT01313520|144556386|SUPERIORITY_OR_OTHER|||||||0.011||95.0|||||Fisher Exact|||||||0.011
72513168|NCT01313520|144556387|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Constrained longitudinal data analysis|||||||<0.0001
72513169|NCT01313520|144556388|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||van Elteren test|||||||0.001
72513170|NCT01313520|144556389|SUPERIORITY_OR_OTHER|||||||0.0005||95.0|||||van Elteren test|||||||0.0005
72513171|NCT01313520|144556390|SUPERIORITY_OR_OTHER||Effect Size|1.4|||||TWO_SIDED|90.0|0.92|1.87||||||||1.87|0.92|
72513172|NCT01313520|144556391|SUPERIORITY_OR_OTHER||Effect Size|1.1|||||TWO_SIDED|90.0|0.64|1.55||||||||1.55|0.64|
72513173|NCT03736629|144556396|SUPERIORITY||Mean Difference (Net)|-0.67|STANDARD_ERROR_OF_MEAN|1.72||0.72|TWO_SIDED|95.0|-6.14|4.81|||t-test, 2 sided|||Study did not reach its accrual goal. Sample size is too small to draw any conclusions.||4.81|-6.14|0.72
72513174|NCT03736629|144556397|SUPERIORITY||Mean Difference (Net)|-5.67||||0.59|TWO_SIDED|95.0|-35.98|24.65|||t-test, 2 sided||Study did not reach its accrual goal. Sample size is too small to draw any conclusions.|||24.65|-35.98|0.59
72513175|NCT03736629|144556400|SUPERIORITY|||||||1|||||||Fisher Exact|||Study did not reach its accrual goal. Sample size is too small to draw any conclusions.||||1.0
72513176|NCT00967226|144556404|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.06|STANDARD_DEVIATION|0.05||0.77|||||||t-test, 2 sided|||intention to treat analysis||||0.77
72513177|NCT01042613|144556424|SUPERIORITY_OR_OTHER||Difference of the Binomial Proportions|0.02||||0.851||95.0|||||Fisher Exact|||||||.851
72513178|NCT01042613|144556425|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.22||||0.105||95.0|||||Wilcoxon (Mann-Whitney)|||||||.105
72513179|NCT01042613|144556426|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.07||||0.8||95.0|||||Wilcoxon (Mann-Whitney)|||||||.8
72576928|NCT00261443|144680717|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|1.26||||0.369|TWO_SIDED|95.0|0.76|2.08||CMH General Association Test controlling for mood stabilizer.|Cochran-Mantel-Haenszel|||"At Any Time Treatment Comparison"||2.08|0.76|0.369
72567740|NCT01663727|144667067|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.85||||0.2745|TWO_SIDED|95.0|0.63|1.14|||Log Rank||Hazards ratio was estimated by Cox regression.|Stratified analysis: Stratification factors were prior adjuvant chemotherapy (yes/no) and estrogen receptor / progesterone receptor status (positive, negative).||1.14|0.63|0.2745
72486092|NCT00791258|144500123|SUPERIORITY_OR_OTHER||Median Difference (Net)|-14.6|||<|0.0001|TWO_SIDED|95.0|-15.4|-13.8|||t-test, 1 sided|||4 week analysis||-13.8|-15.4|<0.0001
72486093|NCT00791258|144500123|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-16.6|||<|0.0001|TWO_SIDED|95.0|-17.7|-15.7|||t-test, 1 sided|||8 week analysis||-15.7|-17.7|<0.0001
72486094|NCT00791258|144500123|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-21.8|||<|0.0001|TWO_SIDED|95.0|-22.7|-20.9|||t-test, 1 sided|||12 week analysis||-20.9|-22.7|<0.0001
72486095|NCT00791258|144500123|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-26.0|||<|0.0001|TWO_SIDED|95.0|-27.0|-25.0|||t-test, 1 sided|||16 week analysis||-25.0|-27.0|<0.0001
72486096|NCT00791258|144500123|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-26.8|||<|0.0001|TWO_SIDED|95.0|-27.8|-25.7|||t-test, 1 sided|||20 week analysis||-25.7|-27.8|<0.0001
72486097|NCT00791258|144500124|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-8.1|||<|0.0001|TWO_SIDED|95.0|-8.6|-7.6|||t-test, 1 sided|||4 week analysis||-7.6|-8.6|<0.0001
72486098|NCT00791258|144500124|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-9.1|||<|0.0001|TWO_SIDED|95.0|-9.7|-8.5|||t-test, 1 sided|||8 week analysis||-8.5|-9.7|<0.0001
72486099|NCT00791258|144500124|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-11.9|||<|0.0001|TWO_SIDED|95.0|-12.5|-11.4|||t-test, 1 sided|||12 week analysis||-11.4|-12.5|<0.0001
72486100|NCT00791258|144500124|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-14.6|||<|0.0001|TWO_SIDED|95.0|-15.2|-14.0|||t-test, 1 sided|||16 week analysis||-14.0|-15.2|<0.0001
72486101|NCT00791258|144500124|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-14.5||||0.0001|TWO_SIDED|95.0|-15.1|-13.8|||t-test, 1 sided|||20 week analysis||-13.8|-15.1|0.0001
72486102|NCT00791258|144500136|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-14.8|||<|0.0001|TWO_SIDED|95.0|-16.2|-13.4|||t-test, 1 sided|||Mean 24-hour systolic blood pressure||-13.4|-16.2|<0.0001
72486103|NCT00791258|144500136|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-16.3|||<|0.0001|TWO_SIDED|95.0|-17.8|-14.8|||t-test, 1 sided|||Mean daytime systolic blood pressure||-14.8|-17.8|<0.0001
72567741|NCT01663727|144667067|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.87||||0.3616|TWO_SIDED|95.0|0.65|1.17|||Log Rank||Hazards ratio was estimated by Cox regression.|Unstratified analysis.||1.17|0.65|0.3616
72486104|NCT00791258|144500136|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-12.5|||<|0.0001|TWO_SIDED|95.0|-14.1|-10.8|||t-test, 1 sided|||Mean nighttime systolic blood pressure||-10.8|-14.1|<0.0001
72486105|NCT00791258|144500136|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-13.6|||<|0.0001|TWO_SIDED|95.0|-15.7|-11.6|||t-test, 1 sided|||systolic blood pressure during last 2 hours of dose||-11.6|-15.7|<0.0001
72486106|NCT00791258|144500136|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-13.0|||<|0.0001|TWO_SIDED|95.0|-14.7|-11.2|||t-test, 1 sided|||systolic blood pressure during last 4 hours of dose||-11.2|-14.7|<0.0001
72486107|NCT00791258|144500136|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-12.6|||<|0.0001|TWO_SIDED|95.0|-14.3|-10.9|||t-test, 1 sided|||systolic blood pressure during last 6 hours of dose||-10.9|-14.3|<0.0001
72486108|NCT00791258|144500136|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-9.4|||<|0.0001||95.0|-10.3|-8.5|||t-test, 1 sided|||Mean 24-hour diastolic blood pressure||-8.5|-10.3|<0.0001
72486109|NCT00791258|144500136|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-10.6|||<|0.0001|TWO_SIDED|95.0|-11.7|-9.6|||t-test, 1 sided|||Mean daytime diastolic blood pressure||-9.6|-11.7|<0.0001
72486110|NCT00791258|144500136|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-7.6|||<|0.0001|TWO_SIDED|95.0|-8.8|-6.4|||t-test, 1 sided|||Mean nighttime diastolic blood pressure||-6.4|-8.8|<0.0001
72486111|NCT00791258|144500136|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-8.6|||<|0.0001||95.0|-10.0|-7.2|||t-test, 1 sided|||diastolic blood pressure during last 2 hours of dose||-7.2|-10.0|<0.0001
72486112|NCT00791258|144500136|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-8.0|||<|0.0001|TWO_SIDED|95.0|-9.2|-6.8|||t-test, 1 sided|||diastolic blood pressure during last 4 hours of dose||-6.8|-9.2|<0.0001
72486113|NCT00791258|144500136|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-7.7|||<|0.0001||95.0|-8.8|-6.6|||t-test, 1 sided|||diastolic blood pressure during last 6 hours of dose||-6.6|-8.8|<0.0001
72486114|NCT00791258|144500137|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-21.0|||<|0.0001|TWO_SIDED|95.0|-22.6|-19.3|||t-test, 1 sided|||24-hour mean systolic blood pressure||-19.3|-22.6|<0.0001
72486115|NCT00791258|144500137|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-23.2|||<|0.0001|TWO_SIDED|95.0|-25.1|-21.4|||t-test, 1 sided|||Mean daytime systolic blood pressure||-21.4|-25.1|<0.0001
72486116|NCT00791258|144500137|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-17.5|||<|0.0001|TWO_SIDED|95.0|-19.4|-15.6|||t-test, 1 sided|||Mean nighttime systolic blood pressure||-15.6|-19.4|<0.0001
72486117|NCT00791258|144500137|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-19.6|||<|0.0001|TWO_SIDED|95.0|-21.7|-17.4|||t-test, 1 sided|||Systolic blood pressure - last 2 hours of dose||-17.4|-21.7|<0.0001
72567742|NCT01663727|144667068|SUPERIORITY_OR_OTHER||Difference in Response Rates|20.78|||<|0.0001|TWO_SIDED|95.0|11.45|30.11|||Fisher|||||30.11|11.45|<0.0001
72576929|NCT00261443|144680718|SUPERIORITY_OR_OTHER_LEGACY|||||||0.685||95.0||||CMH General Association Test controlling for mood stabilizer.|Cochran-Mantel-Haenszel|||Week 12 Treatment Comparison||||0.685
72486118|NCT00791258|144500137|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-18.2|||<|0.0001|TWO_SIDED|95.0|-20.2|-16.3|||t-test, 1 sided|||Systolic blood pressure - last 4 hours of dose||-16.3|-20.2|<0.0001
72486119|NCT00791258|144500137|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-17.9|||<|0.0001|TWO_SIDED|95.0|-19.7|-16.0|||t-test, 1 sided|||Systolic blood pressure - last 6 hours of dose||-16.0|-19.7|<0.0001
72486120|NCT00791258|144500137|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-13.3|||<|0.0001|TWO_SIDED|95.0|-14.4|-12.2|||t-test, 1 sided|||24-hour mean diastolic blood pressure||-12.2|-14.4|<0.0001
72486121|NCT00791258|144500137|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-15.0|||<|0.0001|TWO_SIDED|95.0|-16.2|-13.8|||t-test, 1 sided|||Mean daytime diastolic blood pressure||-13.8|-16.2|<0.0001
72486122|NCT00791258|144500137|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-11.1|||<|0.0001|TWO_SIDED|95.0|-12.4|-9.8|||t-test, 1 sided|||Mean nighttime diastolic blood pressure||-9.8|-12.4|<0.0001
72486123|NCT00791258|144500137|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-12.3|||<|0.0001|TWO_SIDED|95.0|-13.8|-10.8|||t-test, 1 sided|||Diastolic blood pressure - last 2 hours of dose||-10.8|-13.8|<0.0001
72402740|NCT01480076|144311692|SUPERIORITY_OR_OTHER|||||||0.8041|||||||mixed effect model|||Overall, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.8041
72402741|NCT01480076|144311692|SUPERIORITY_OR_OTHER||difference of LS means|11.8|STANDARD_ERROR_OF_MEAN|1.85|<|0.0001|TWO_SIDED||||||mixed effect model|||Overall, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
72486124|NCT00791258|144500137|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-11.6|||<|0.0001|TWO_SIDED|95.0|-12.9|-10.2|||t-test, 1 sided|||Diastolic blood pressure - last 4 hours of dose||-10.2|-12.9|<0.0001
72486125|NCT00791258|144500137|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-11.3|||<|0.0001|TWO_SIDED|95.0|-12.6|-10.0|||t-test, 1 sided|||Diastolic blood pressure - last 6 hours of dose||-10.0|-12.6|<0.0001
72486126|NCT00922480|144500179|NON_INFERIORITY|Non-Inferiority||||||0.0001|||||||t-test, 2 sided|Paired t-test||||||0.0001
72486127|NCT00922480|144500180|NON_INFERIORITY|Non-Inferiority||||||0.0001|||||||t-test, 2 sided|Paired t-test||||||0.0001
72486128|NCT04784897|144500181|SUPERIORITY||Cox Proportional Hazard|0.9289||||0.7273|TWO_SIDED|90.0|0.6585|1.3102|||Log Rank|||Main comparison is between Brilacidin 5-dose and Pooled Placebo||1.3102|0.6585|0.7273
72486129|NCT04784897|144500181|SUPERIORITY||Cox Proportional Hazard|0.8968||||0.5975|TWO_SIDED|90.0|0.5464|1.472|||Log Rank|||Secondary comparison between Brilacidin 3-dose and Pooled Placebo||1.4720|0.5464|0.5975
72486130|NCT04667377|144500200|OTHER|Covariate adjusted fixed effect estimates of mean percentage change in body weight at Week 46 for each treatment group with associated covariance matrix were extracted from the MMRM (including fixed effects for baseline body weight as a continuous linear covariate, and treatment, gender, visit, treatment by visit interaction and baseline by visit interaction as factors) and used as input for the MCP-Mod.|||||<|0.0001||||||P-value is adjusted for multiplicity.|MCP-Mod - Linear model fit|||A flat vs. non-flat dose-response relationship across the 4 doses of BI 456906 and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different potential dose-response patterns (Linear, Exponential, Emax1, Emax2, Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 2.5%).||||<0.0001
72486131|NCT04667377|144500200|OTHER|Covariate adjusted fixed effect estimates of mean percentage change in body weight at Week 46 for each treatment group with associated covariance matrix were extracted from the MMRM (including fixed effects for baseline body weight as a continuous linear covariate, and treatment, gender, visit, treatment by visit interaction and baseline by visit interaction as factors) and used as input for the MCP-Mod.|||||<|0.0001||||||P-value is adjusted for multiplicity.|MCP-Mod - Exponential model fit|Model Assumption: 50% of maximum effect achieved at dose 3.6 mg.||A flat vs. non-flat dose-response relationship across the 4 doses of BI 456906 and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different potential dose-response patterns (Linear, Exponential, Emax1, Emax2, Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 2.5%).||||<0.0001
72513180|NCT00487084|144556427|SUPERIORITY_OR_OTHER|||||||0.006||95.0|||||Log Rank|||A sample of 56 was estimated to have an 80% power to detect a 30% difference in the proportion of subjects with continuing analgesia in the MCS versus the SCM groups when 50% of the subjects in the SCM had requested supplemental analgesia. 28 subjects was added to compare the influence of time of morphine and 2-chloroprocaine administration to lidocaine-morphine analgesia. The primary outcome was compared using Kaplan-Meier survival analysis and the log-rank test.||||0.006
72513181|NCT00487084|144556427|SUPERIORITY_OR_OTHER|||||||0.83||95.0|||||Log Rank|||||||0.83
72513182|NCT00487084|144556427|SUPERIORITY_OR_OTHER|||||||0.009||95.0|||||Log Rank|||||||0.009
72513183|NCT00487084|144556428|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Kruskal-Wallis|||||||<0.05
72513184|NCT00487084|144556428|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Kruskal-Wallis|||||||<0.05
72513185|NCT00487084|144556429|SUPERIORITY_OR_OTHER|||||||0.01||95.0|||||Chi-squared, Corrected|||||||0.01
72513186|NCT00487084|144556429|SUPERIORITY_OR_OTHER|||||||0.01||95.0|||||Chi-squared, Corrected|||||||0.01
72513187|NCT00487084|144556430|SUPERIORITY_OR_OTHER|||||||0.2||95.0|||||Chi-squared, Corrected|||||||0.20
72513188|NCT02568345|144556447|SUPERIORITY_OR_OTHER||isotonic regression functions through PA|2.2|||||TWO_SIDED|||||The isotonic regression functions through PAVA algorithm were used (pooled adjacent violators algorithm), to determine the ED90, and bootstrapping to calculate the respective 95% confidence interval with the statistical program R||||||||
72513189|NCT03209440|144556448|SUPERIORITY||Mean Difference (Net)|1.67|STANDARD_ERROR_OF_MEAN|0.73||0.02|TWO_SIDED||||||Regression, Linear|||||||0.02
72513190|NCT03209440|144556448|SUPERIORITY||Mean Difference (Net)|2.07|STANDARD_ERROR_OF_MEAN|0.74||0.005|TWO_SIDED||||||Regression, Linear|||||||0.005
72513191|NCT03209440|144556449|SUPERIORITY||Mean Difference (Net)|-0.62|STANDARD_ERROR_OF_MEAN|0.49||0.21|TWO_SIDED||||||Regression, Linear|||||||0.21
72513192|NCT03209440|144556449|SUPERIORITY||Median Difference (Net)|-0.79|STANDARD_ERROR_OF_MEAN|0.5||0.12|TWO_SIDED||||||Regression, Linear|||||||0.12
72513193|NCT03209440|144556450|SUPERIORITY||Mean Difference (Net)|0.9|STANDARD_ERROR_OF_MEAN|0.72||0.21|TWO_SIDED||||||Regression, Linear|||||||0.21
72513194|NCT03209440|144556450|SUPERIORITY||Mean Difference (Net)|0.91|STANDARD_ERROR_OF_MEAN|0.73||0.21|TWO_SIDED||||||Regression, Linear|||||||0.21
72513195|NCT03209440|144556451|SUPERIORITY||Odds Ratio, log|1.0|STANDARD_ERROR_OF_MEAN|0.62||0.11|TWO_SIDED||||||Regression, Logistic|||||||0.11
72513196|NCT03209440|144556451|SUPERIORITY||Odds Ratio, log|0.96|STANDARD_ERROR_OF_MEAN|0.64||0.14|TWO_SIDED||||||Regression, Logistic|||||||0.14
72513197|NCT03209440|144556452|SUPERIORITY||Mean Difference (Net)|0.35|STANDARD_ERROR_OF_MEAN|0.17||0.05|TWO_SIDED||||||Regression, Linear|"The outcome variable was scored as 1= prolong life; treat everything to 4 = provide comfort care only."||||||0.05
72576930|NCT00261443|144680718|SUPERIORITY_OR_OTHER_LEGACY|||||||0.792||95.0||||CMH General Association Test controlling for mood stabilizer.|Cochran-Mantel-Haenszel|||Week 24 Treatment Comparison||||0.792
72486132|NCT04667377|144500200|OTHER|Covariate adjusted fixed effect estimates of mean percentage change in body weight at Week 46 for each treatment group with associated covariance matrix were extracted from the MMRM (including fixed effects for baseline body weight as a continuous linear covariate, and treatment, gender, visit, treatment by visit interaction and baseline by visit interaction as factors) and used as input for the MCP-Mod.|||||<|0.0001||||||P-value is adjusted for multiplicity.|MCP-Mod - Emax1 model fit|Model Assumption: 90% of maximum effect achieved at dose 4.8 mg.||A flat vs. non-flat dose-response relationship across the 4 doses of BI 456906 and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different potential dose-response patterns (Linear, Exponential, Emax1, Emax2, Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 2.5%).||||<0.0001
72486133|NCT04667377|144500200|OTHER|Covariate adjusted fixed effect estimates of mean percentage change in body weight at Week 46 for each treatment group with associated covariance matrix were extracted from the MMRM (including fixed effects for baseline body weight as a continuous linear covariate, and treatment, gender, visit, treatment by visit interaction and baseline by visit interaction as factors) and used as input for the MCP-Mod.|||||<|0.0001||||||P-value is adjusted for multiplicity.|MCP-Mod - Emax2 model fit|Model Assumption: 70% of maximum effect achieved at dose 4.8 mg.||A flat vs. non-flat dose-response relationship across the 4 doses of BI 456906 and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different potential dose-response patterns (Linear, Exponential, Emax1, Emax2, Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 2.5%).||||<0.0001
72486134|NCT04667377|144500200|OTHER|Covariate adjusted fixed effect estimates of mean percentage change in body weight at Week 46 for each treatment group with associated covariance matrix were extracted from the MMRM (including fixed effects for baseline body weight as a continuous linear covariate, and treatment, gender, visit, treatment by visit interaction and baseline by visit interaction as factors) and used as input for the MCP-Mod.|||||<|0.0001||||||P-value is adjusted for multiplicity.|MCP-Mod - Sigmoid Emax model fit|Model Assumption: 50% of maximum effect achieved at dose 2.4 mg, 90% of maximum effect achieved at dose 4.8 mg.||A flat vs. non-flat dose-response relationship across the 4 doses of BI 456906 and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different potential dose-response patterns (Linear, Exponential, Emax1, Emax2, Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 2.5%).||||<0.0001
72486135|NCT04667377|144500200|OTHER|MMRM with fixed effects for baseline body weight as a continuous linear covariate, and treatment, gender, visit, treatment by visit interaction and baseline by visit interaction as factors, using visit as repeated measures and an unstructured covariance matrix to model within subject measurements.|Difference of adjusted means|-3.37|STANDARD_ERROR_OF_MEAN|1.5||0.0257|TWO_SIDED|95.0|-6.33|-0.41||P-value is considered nominal.|Mixed Models Analysis|Kenward-Roger approximation was used to estimate the denominator degrees of freedom.|Difference was calculated as BI 456906 - placebo.|No formal hypotheses were tested.||-0.41|-6.33|0.0257
72486136|NCT04667377|144500200|OTHER|MMRM with fixed effects for baseline body weight as a continuous linear covariate, and treatment, gender, visit, treatment by visit interaction and baseline by visit interaction as factors, using visit as repeated measures and an unstructured covariance matrix to model within subject measurements.|Difference of adjusted means|-9.69|STANDARD_ERROR_OF_MEAN|1.46|<|0.0001|TWO_SIDED|95.0|-12.57|-6.81||P-value is considered nominal.|Mixed Models Analysis|Kenward-Roger approximation as used to estimate the denominator degrees of freedom.|Difference was calculated as BI 456906 - placebo.|No formal hypotheses were tested.||-6.81|-12.57|<.0001
72513198|NCT03209440|144556452|SUPERIORITY||Mean Difference (Net)|0.13|STANDARD_ERROR_OF_MEAN|0.18||0.46|TWO_SIDED||||||Regression, Linear|"The outcome variable was scored as 1= prolong life; treat everything to 4 = provide comfort care only."||||||0.46
72513199|NCT02338492|144556468|SUPERIORITY|||||||0.615||||||P-value not adjusted for multiple comparisons as the second co-primary endpoint will only be tested if the p-value for VAS improvement is \<0.05.|Mixed Models Analysis|Mixed model repeated measures (MMRM) model employed, including the baseline VAS score. Missing values will be imputed.||Null hypothesis: Mean improvement in VAS over 90 days \<= 53.8 (i.e. 80% of reference based on historical control data). The study was powered to 80% with 68 evaluable subjects, a standard deviation of 13.3 at each visit, a true mean improvement from baseline VAS across post-baseline visits of 57 and a within-patient correlation of VAS of 0.4. The historical control data comes from 4 selected articles (Gregory et al. 2011, Kim et al. 2011, Deschamps et al. 2012, and Pretell et al. 2010).||||0.615
72513200|NCT02338492|144556470|OTHER||Percentage of Subjects|100.0|||||TWO_SIDED|95.0|96.0|100.0||||||95% exact binomial confidence intervals provided for each of the parameters that make up the safety success endpoint and the safety success endpoint - Up to Day 7-14: Subjects who had no serious device related complications||100|96|
72513201|NCT02338492|144556470|OTHER||Percentage of Subjects|100.0|||||TWO_SIDED|95.0|96.0|100.0||||||95% exact binomial confidence intervals provided for each of the parameters that make up the safety success endpoint and the safety success endpoint - Up to Day 7-14: No additional surgical interventions of revisions, supplements, fixations or removals||100|96|
72513202|NCT02338492|144556470|OTHER||Percentage of Subjects|98.8|||||TWO_SIDED|95.0|93.0|100.0||||||95% exact binomial confidence intervals provided for each of the parameters that make up the safety success endpoint and the safety success endpoint - Up to Day 7-14: Subjects who had no device fracture, migration, mal-alignment or loss of reduction or fixation||100|93|
72513203|NCT02338492|144556470|OTHER||Percentage of Subjects|98.8|||||TWO_SIDED|95.0|93.0|100.0||||||95% exact binomial confidence intervals provided for each of the parameters that make up the safety success endpoint and the safety success endpoint - Up to Day 7-14: Safety Success||100|93|
72513204|NCT02338492|144556470|OTHER||Percentage of Subjects|98.8|||||TWO_SIDED|95.0|93.0|100.0||||||95% exact binomial confidence intervals provided for each of the parameters that make up the safety success endpoint and the safety success endpoint - Up to Day 7-14: Subjects who had no serious device related complications||100|93|
72513205|NCT02338492|144556470|OTHER||Percentage of Subjects|98.8|||||TWO_SIDED|95.0|93.0|100.0||||||95% exact binomial confidence intervals provided for each of the parameters that make up the safety success endpoint and the safety success endpoint - Up to Day 30: No additional surgical interventions of revisions, supplements, fixations or removals||100|93|
72576931|NCT00261443|144680718|SUPERIORITY_OR_OTHER_LEGACY|||||||0.805||95.0||||CMH General Association Test controlling for mood stabilizer.|Cochran-Mantel-Haenszel|||Week 36 Treatment Comparison||||0.805
72486137|NCT04667377|144500200|OTHER|MMRM with fixed effects for baseline body weight as a continuous linear covariate, and treatment, gender, visit, treatment by visit interaction and baseline by visit interaction as factors, using visit as repeated measures and an unstructured covariance matrix to model within subject measurements.|Difference of adjusted means|-10.4|STANDARD_ERROR_OF_MEAN|1.48|<|0.0001|TWO_SIDED|95.0|-13.32|-7.49||P-value is considered nominal.|Mixed Models Analysis|Kenward-Roger approximation was used to estimate the denominator degrees of freedom.|Difference was calculated as BI 456906 - placebo.|No formal hypotheses were tested.||-7.49|-13.32|<.0001
72486138|NCT04667377|144500200|OTHER|MMRM with fixed effects for baseline body weight as a continuous linear covariate, and treatment, gender, visit, treatment by visit interaction and baseline by visit interaction as factors, using visit as repeated measures and an unstructured covariance matrix to model within subject measurements.|Difference of adjusted means|-12.12|STANDARD_ERROR_OF_MEAN|1.46|<|0.0001|TWO_SIDED|95.0|-15.0|-9.24||P-value is considered nominal.|Mixed Models Analysis|Kenward-Roger approximation will be used to estimate the denominator degrees of freedom.|Difference was calculated as BI 456906 - placebo.|No formal hypotheses were tested.||-9.24|-15.00|<.0001
72486139|NCT04667377|144500201|OTHER|"Missing body weight measurements were multiply imputed using MMRM with treatment, gender, baseline body weight as factors. Percentage change in body weight from baseline to Week 46 and Body weight loss ≥ 5% at Week 46 (yes/no) were derived per participant in each of the 1000 imputed datasets. Each dataset was analysed by a logistic regression. Multiple estimates from multiple imputation runs were summarised using Rubin's method."|Odds Ratio (OR)|3.28||||0.0015|TWO_SIDED|95.0|1.57|6.84||P-value is considered nominal.|Regression, Logistic|Logistic regression with treatment group and gender as factors and baseline body weight as a continuous linear covariate.|Odds ratio is calculated as BI 456906 / Placebo.|Logistic regression after multiple imputation. Analysis based on all available post-baseline body weight measurements (on-treatment (first intake of study drug until 28 days after last intake of study drug) and off-treatment), except those for participants who discontinued treatment early due to COVID-19. For these participants only on-treatment values were used.||6.84|1.57|0.0015
72486140|NCT04667377|144500201|OTHER|"Missing body weight measurements were multiply imputed using MMRM with treatment, gender, baseline body weight as factors. Percentage change in body weight from baseline to Week 46 and Body weight loss ≥ 5% at Week 46 (yes/no) were derived per participant in each of the 1000 imputed datasets. Each dataset was analysed by a logistic regression. Multiple estimates from multiple imputation runs were summarised using Rubin's method."|Odds Ratio (OR)|8.83|||<|0.0001|TWO_SIDED|95.0|4.0|19.46||P-value is considered nominal.|Regression, Logistic|Logistic regression with treatment group and gender as factors and baseline body weight as a continuous linear covariate.|Odds ratio is calculated as BI 456906 / Placebo.|Logistic regression after multiple imputation. Analysis based on all available post-baseline body weight measurements (on-treatment (first intake of study drug until 28 days after last intake of study drug) and off-treatment), except those for participants who discontinued treatment early due to COVID-19. For these participants only on-treatment values were used.||19.46|4.00|<.0001
72486141|NCT04667377|144500201|OTHER|"Missing body weight measurements were multiply imputed using MMRM with treatment, gender, baseline body weight as factors. Percentage change in body weight from baseline to Week 46 and Body weight loss ≥ 5% at Week 46 (yes/no) were derived per participant in each of the 1000 imputed datasets. Each dataset was analysed by a logistic regression. Multiple estimates from multiple imputation runs were summarised using Rubin's method."|Odds Ratio (OR)|7.48|||<|0.0001|TWO_SIDED|95.0|3.41|16.41||P-value is considered nominal.|Regression, Logistic|Logistic regression with treatment group and gender as factors and baseline body weight as a continuous linear covariate.|Odds ratio is calculated as BI 456906 / Placebo.|Logistic regression after multiple imputation. Analysis based on all available post-baseline body weight measurements (on-treatment (first intake of study drug until 28 days after last intake of study drug) and off-treatment), except those for participants who discontinued treatment early due to COVID-19. For these participants only on-treatment values were used.||16.41|3.41|<.0001
72513206|NCT02338492|144556470|OTHER||Percentage of Subjects|96.3|||||TWO_SIDED|95.0|90.0|99.0||||||95% exact binomial confidence intervals provided for each of the parameters that make up the safety success endpoint and the safety success endpoint - Up to Day 30: Subjects who had no device fracture, migration, mal-alignment or loss of reduction or fixation||99|90|
72513207|NCT02338492|144556470|OTHER||Percentage of Subjects|96.3|||||TWO_SIDED|95.0|90.0|99.0||||||95% exact binomial confidence intervals provided for each of the parameters that make up the safety success endpoint and the safety success endpoint - Up to Day 30: Safety Success||99|90|
72513208|NCT02338492|144556470|OTHER||Percentage of Subjects|96.3|||||TWO_SIDED|95.0|90.0|99.0||||||95% exact binomial confidence intervals provided for each of the parameters that make up the safety success endpoint and the safety success endpoint - Up to Day 90: Subjects who had no serious device related complications||99|90|
72513209|NCT02338492|144556470|OTHER||Percentage of Subjects|98.8|||||TWO_SIDED|95.0|93.0|100.0||||||95% exact binomial confidence intervals provided for each of the parameters that make up the safety success endpoint and the safety success endpoint - Up to Day 90: No additional surgical interventions of revisions, supplements, fixations or removals||100|93|
72513210|NCT02338492|144556470|OTHER||Percentage of Subjects|93.8|||||TWO_SIDED|95.0|86.0|98.0||||||95% exact binomial confidence intervals provided for each of the parameters that make up the safety success endpoint and the safety success endpoint - Up to Day 90: Subjects who had no device fracture, migration, mal-alignment or loss of reduction or fixation||98|86|
72513211|NCT02338492|144556470|OTHER||Percentage of Subjects|92.6|||||TWO_SIDED|95.0|85.0|97.0||||||95% exact binomial confidence intervals provided for each of the parameters that make up the safety success endpoint and the safety success endpoint - Up to Day 90: Safety Success||97|85|
72513212|NCT02338492|144556470|OTHER||Percentage of Subjects|93.8|||||TWO_SIDED|95.0|86.0|98.0||||||95% exact binomial confidence intervals provided for each of the parameters that make up the safety success endpoint and the safety success endpoint - Up to Day 180: Subjects who had no serious device related complications||98|86|
72576932|NCT00261443|144680718|SUPERIORITY_OR_OTHER_LEGACY|||||||0.533||95.0||||CMH General Association Test controlling for mood stabilizer.|Cochran-Mantel-Haenszel|||Week 52 Treatment Comparison||||0.533
72486142|NCT04667377|144500201|OTHER|"Missing body weight measurements were multiply imputed using MMRM with treatment, gender, baseline body weight as factors. Percentage change in body weight from baseline to Week 46 and Body weight loss ≥ 5% at Week 46 (yes/no) were derived per participant in each of the 1000 imputed datasets. Each dataset was analysed by a logistic regression. Multiple estimates from multiple imputation runs were summarised using Rubin's method."|Odds Ratio (OR)|10.77|||<|0.0001|TWO_SIDED|95.0|4.77|24.31||P-value is considered nominal.|Regression, Logistic|Logistic regression with treatment group and gender as factors and baseline body weight as a continuous linear covariate.|Odds ratio is calculated as BI 456906 / Placebo.|Logistic regression after multiple imputation. Analysis based on all available post-baseline body weight measurements (on-treatment (first intake of study drug until 28 days after last intake of study drug) and off-treatment), except those for participants who discontinued treatment early due to COVID-19. For these participants only on-treatment values were used.||24.31|4.77|<.0001
72486143|NCT04667377|144500202|OTHER|"Missing body weight measurements were multiply imputed using MMRM with treatment, gender, baseline body weight as factors. Percentage change in body weight from baseline to Week 46 and Body weight loss ≥ 10% at Week 46 (yes/no) were derived per participant in each of the 1000 imputed datasets. Each dataset was analysed by a logistic regression. Multiple estimates from multiple imputation runs were summarised using Rubin's method."|Odds Ratio (OR)|3.22||||0.012|TWO_SIDED|95.0|1.29|8.02||P-value is considered nominal.|Regression, Logistic|Logistic regression with treatment group and gender as factors and baseline body weight as a continuous linear covariate.|Odds ratio is calculated as BI 456906 / Placebo.|Logistic regression after multiple imputation. Analysis based on all available post-baseline body weight measurements (on-treatment (first intake of study drug until 28 days after last intake of study drug) and off-treatment), except those for participants who discontinued treatment early due to COVID-19. For these participants only on-treatment values were used.||8.02|1.29|0.0120
72486144|NCT04667377|144500202|OTHER|"Missing body weight measurements were multiply imputed using MMRM with treatment, gender, baseline body weight as factors. Percentage change in body weight from baseline to Week 46 and Body weight loss ≥ 10% at Week 46 (yes/no) were derived per participant in each of the 1000 imputed datasets. Each dataset was analysed by a logistic regression. Multiple estimates from multiple imputation runs were summarised using Rubin's method."|Odds Ratio (OR)|10.62|||<|0.0001|TWO_SIDED|95.0|4.36|25.86||P-value is considered nominal.|Regression, Logistic|Logistic regression with treatment group and gender as factors and baseline body weight as a continuous linear covariate.|Odds ratio is calculated as BI 456906 / Placebo.|Logistic regression after multiple imputation. Analysis based on all available post-baseline body weight measurements (on-treatment (first intake of study drug until 28 days after last intake of study drug) and off-treatment), except those for participants who discontinued treatment early due to COVID-19. For these participants only on-treatment values were used.||25.86|4.36|<.0001
72486145|NCT04667377|144500202|OTHER|"Missing body weight measurements were multiply imputed using MMRM with treatment, gender, baseline body weight as factors. Percentage change in body weight from baseline to Week 46 and Body weight loss ≥ 10% at Week 46 (yes/no) were derived per participant in each of the 1000 imputed datasets. Each dataset was analysed by a logistic regression. Multiple estimates from multiple imputation runs were summarised using Rubin's method."|Odds Ratio (OR)|9.78|||<|0.0001|TWO_SIDED|95.0|4.02|23.79||P-value is considered nominal.|Regression, Logistic|Logistic regression with treatment group and gender as factors and baseline body weight as a continuous linear covariate.|Odds ratio is calculated as BI 456906 / Placebo.|Logistic regression after multiple imputation. Analysis based on all available post-baseline body weight measurements (on-treatment (first intake of study drug until 28 days after last intake of study drug) and off-treatment), except those for participants who discontinued treatment early due to COVID-19. For these participants only on-treatment values were used.||23.79|4.02|<.0001
72486146|NCT04667377|144500202|OTHER|"Missing body weight measurements were multiply imputed using MMRM with treatment, gender, baseline body weight as factors. Percentage change in body weight from baseline to Week 46 and Body weight loss ≥ 10% at Week 46 (yes/no) were derived per participant in each of the 1000 imputed datasets. Each dataset was analysed by a logistic regression. Multiple estimates from multiple imputation runs were summarised using Rubin's method."|Odds Ratio (OR)|14.5|||<|0.0001|TWO_SIDED|95.0|5.91|35.55||P-value is considered nominal.|Regression, Logistic|Logistic regression with treatment group and gender as factors and baseline body weight as a continuous linear covariate.|Odds ratio is calculated as BI 456906 / Placebo.|Logistic regression after multiple imputation. Analysis based on all available post-baseline body weight measurements (on-treatment (first intake of study drug until 28 days after last intake of study drug) and off-treatment), except those for participants who discontinued treatment early due to COVID-19. For these participants only on-treatment values were used.||35.55|5.91|<.0001
72567743|NCT01663727|144667070|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.64||||0.0038|TWO_SIDED|96.0|0.47|0.88|||Log Rank||Hazards ratio was estimated by Cox regression.|Stratified analysis: Stratification factors were prior adjuvant chemotherapy (yes/no) and estrogen receptor / progesterone receptor status (positive, negative).||0.88|0.47|0.0038
72513213|NCT02338492|144556470|OTHER||Percentage of Subjects|95.1|||||TWO_SIDED|95.0|88.0|99.0||||||95% exact binomial confidence intervals provided for each of the parameters that make up the safety success endpoint and the safety success endpoint - Up to Day 180: No additional surgical interventions of revisions, supplements, fixations or removals||99|88|
72513214|NCT02338492|144556470|OTHER||Percentage of Subjects|86.4|||||TWO_SIDED|95.0|77.0|93.0||||||95% exact binomial confidence intervals provided for each of the parameters that make up the safety success endpoint and the safety success endpoint - Up to Day 180: Subjects who had no device fracture, migration, mal-alignment or loss of reduction or fixation||93|77|
72567744|NCT01663727|144667070|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.68||||0.0101|TWO_SIDED|96.0|0.5|0.93|||Log Rank|||Unstratified analysis.||0.93|0.50|0.0101
72567745|NCT01663727|144667071|SUPERIORITY_OR_OTHER||Difference in Response Rates|21.53||||0.0017|TWO_SIDED|95.0|8.73|34.32|||Fisher|||||34.32|8.73|0.0017
72567746|NCT01663727|144667072|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.8||||0.2737|TWO_SIDED|95.0|0.54|1.19|||Log Rank||Hazards ratio was estimated by Cox regression.|Stratified analysis: Stratification factors were plasma VEGF-A level (low/high), prior adjuvant chemotherapy (yes/no) and estrogen receptor / progesterone receptor status (positive, negative).||1.19|0.54|0.2737
72567747|NCT01663727|144667072|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.82||||0.2959|TWO_SIDED|95.0|0.56|1.19|||Log Rank||Hazards ratio was estimated by Cox regression.|Unstratified analysis.||1.19|0.56|0.2959
72402742|NCT01480076|144311692|SUPERIORITY_OR_OTHER||difference of LS means|9.4|STANDARD_ERROR_OF_MEAN|3.1||0.0026|TWO_SIDED||||||mixed effect model|||Overall, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0026
72402743|NCT01480076|144311692|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 3, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
72402744|NCT01480076|144311692|SUPERIORITY_OR_OTHER|||||||0.0689|||||||mixed effect model|||Month 3, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0689
72402745|NCT01480076|144311692|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 3, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
72402746|NCT01480076|144311692|SUPERIORITY_OR_OTHER|||||||0.7182|||||||mixed effect model|||Month 3, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.7182
72402747|NCT01480076|144311692|SUPERIORITY_OR_OTHER||difference of LS means|11.6|STANDARD_ERROR_OF_MEAN|2.1|<|0.0001|TWO_SIDED||||||mixed effect model|||Month 3, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
72486147|NCT04667377|144500203|OTHER|"Missing body weight measurements were multiply imputed using MMRM with treatment, gender, baseline body weight as factors. Percentage change in body weight from baseline to Week 46 and Body weight loss ≥ 15% at Week 46 (yes/no) were derived per participant in each of the 1000 imputed datasets. Each dataset was analysed by a logistic regression. Multiple estimates from multiple imputation runs were summarised using Rubin's method."|Odds Ratio (OR)|2.13||||0.2654|TWO_SIDED|95.0|0.56|8.02||P-value is considered nominal.|Regression, Logistic|Logistic regression with treatment group and gender as factors and baseline body weight as a continuous linear covariate.|Odds ratio is calculated as BI 456906 / Placebo.|Logistic regression after multiple imputation. Analysis based on all available post-baseline body weight measurements (on-treatment (first intake of study drug until 28 days after last intake of study drug) and off-treatment), except those for participants who discontinued treatment early due to COVID-19. For these participants only on-treatment values were used.||8.02|0.56|0.2654
72486148|NCT04667377|144500203|OTHER|"Missing body weight measurements were multiply imputed using MMRM with treatment, gender, baseline body weight as factors. Percentage change in body weight from baseline to Week 46 and Body weight loss ≥ 15% at Week 46 (yes/no) were derived per participant in each of the 1000 imputed datasets. Each dataset was analysed by a logistic regression. Multiple estimates from multiple imputation runs were summarised using Rubin's method."|Odds Ratio (OR)|9.47||||0.0002|TWO_SIDED|95.0|2.89|30.95||P-value is considered nominal.|Regression, Logistic|Logistic regression with treatment group and gender as factors and baseline body weight as a continuous linear covariate.|Odds ratio is calculated as BI 456906 / Placebo.|Logistic regression after multiple imputation. Analysis based on all available post-baseline body weight measurements (on-treatment (first intake of study drug until 28 days after last intake of study drug) and off-treatment), except those for participants who discontinued treatment early due to COVID-19. For these participants only on-treatment values were used.||30.95|2.89|0.0002
72402748|NCT01480076|144311692|SUPERIORITY_OR_OTHER||difference of LS means|9.8|STANDARD_ERROR_OF_MEAN|3.57||0.0061|TWO_SIDED||||||mixed effect model|||Month 3, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0061
72402749|NCT01480076|144311692|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 6, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
72513215|NCT02338492|144556470|OTHER||Percentage of Subjects|86.4|||||TWO_SIDED|95.0|77.0|93.0||||||95% exact binomial confidence intervals provided for each of the parameters that make up the safety success endpoint and the safety success endpoint - Up to Day 180: Safety Success||93|77|
72567748|NCT01663727|144667073|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.7||||0.1783|TWO_SIDED|95.0|0.41|1.18|||Log Rank||Hazards ratio was estimated by Cox regression.|Stratified analysis: Stratification factors were prior adjuvant chemotherapy (yes/no) and estrogen receptor / progesterone receptor status (positive, negative).||1.18|0.41|0.1783
72567749|NCT01663727|144667073|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.74||||0.2429|TWO_SIDED|95.0|0.45|1.22|||Log Rank||Hazards ratio was estimated by Cox regression.|Unstratified analysis.||1.22|0.45|0.2429
72624117|NCT01892189|144778533|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.0357|STANDARD_ERROR_OF_MEAN|0.19001||0.852|TWO_SIDED|95.0|-0.4218|0.3505|||ANOVA||Difference between least square means of TAK-063 10 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Left Amygdala: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.3505|-0.4218|0.852
72624118|NCT01892189|144778533|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2154|STANDARD_ERROR_OF_MEAN|0.18048||0.241|TWO_SIDED|95.0|-0.5822|0.1514|||ANOVA||Difference between least square means of TAK-063 30 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Left Amygdala: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.1514|-0.5822|0.241
72624119|NCT01892189|144778533|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.138|STANDARD_ERROR_OF_MEAN|0.17766||0.443|TWO_SIDED|95.0|-0.4991|0.223|||ANOVA||Difference between least square means of TAK-063 3 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Right Amygdala: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.2230|-0.4991|0.443
72513216|NCT02338492|144556470|OTHER||Percentage of Subjects|91.4|||||TWO_SIDED|95.0|83.0|96.0||||||95% exact binomial confidence intervals provided for each of the parameters that make up the safety success endpoint and the safety success endpoint - Up to Day 360: Subjects who had no serious device related complications||96|83|
72513217|NCT02338492|144556470|OTHER||Percentage of Subjects|91.4|||||TWO_SIDED|95.0|83.0|96.0||||||95% exact binomial confidence intervals provided for each of the parameters that make up the safety success endpoint and the safety success endpoint - Up to Day 360: No additional surgical interventions of revisions, supplements, fixations or removals||96|83|
72513218|NCT02338492|144556470|OTHER||Percentage of Subjects|82.7|||||TWO_SIDED|95.0|73.0|90.0||||||95% exact binomial confidence intervals provided for each of the parameters that make up the safety success endpoint and the safety success endpoint - Up to Day 360: Subjects who had no device fracture, migration, mal-alignment or loss of reduction or fixation||90|73|
72513219|NCT02338492|144556470|OTHER||Percentage of Subjects|82.7|||||TWO_SIDED|95.0|73.0|90.0||||||95% exact binomial confidence intervals provided for each of the parameters that make up the safety success endpoint and the safety success endpoint - Up to Day 360: Safety Success||90|73|
72513220|NCT00839423|144556482|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.7|STANDARD_ERROR_OF_MEAN|1.42|<|0.0001|TWO_SIDED|95.0|-8.49|-2.91||"A hierarchical hypothesis testing procedure was used. The comparison of 10 mg to placebo was primary.~Since p-value was \<0.05, hierarchically testing continued."|ANCOVA|||"The statistical model was an analysis of covariance (ANCOVA) of the change from baseline in MADRS total score (FAS, LOCF) with treatment and centre as fixed factors and the baseline MADRS score as a covariate.~Null hypothesis: No difference between 10 mg Vortioxetine and placebo at Week 6.~With 96 patients in each treatment arm and a standard deviation of 9 points, the power to detect a true effect of 3.7 points on the MADRS total score at Week 6 will be 80%."||-2.91|-8.49|<0.0001
72513221|NCT00839423|144556482|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.9|STANDARD_ERROR_OF_MEAN|1.39|<|0.0001|TWO_SIDED|95.0|-8.64|-3.17||"The hierarchical hypothesis testing meant that comparison of 5 mg to placebo was performed at a 5% significance level since significance was achieved for the primary comparison of 10 mg to placebo.~Since p-value \<0.05, hierarchically testing contd."|ANCOVA|||"The statistical model was ANCOVA of the change from baseline in MADRS total score (FAS, LOCF) with treatment and centre as fixed factors and the baseline MADRS score as a covariate.~Null hypothesis: No difference between 5 mg Vortioxetine and placebo at Week 6."||-3.17|-8.64|<0.0001
72513222|NCT00839423|144556482|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.42|STANDARD_ERROR_OF_MEAN|1.38|<|0.0001|TWO_SIDED|95.0|-9.13|-3.72||This treatment arm was not in the testing sequence. A nominal p-value is provided.|ANCOVA|||||-3.72|-9.13|<0.0001
72513223|NCT00839423|144556483|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.82|STANDARD_ERROR_OF_MEAN|0.69||0.2377|TWO_SIDED|95.0|-2.17|0.54||"The hierarchical procedure meant that the above hypothesis was tested at a 5% significance level since significance was achieved for both 10 and 5 mg at Week 6.~Since p-value was \>0.05, hierarchically testing stopped here."|ANCOVA|||"The statistical model was ANCOVA of the change from baseline in MADRS total score (FAS, LOCF) with treatment and centre as fixed factors and the baseline MADRS score as a covariate.~Null hypothesis: No difference between 10 mg Vortioxetine and placebo at Week 1."||0.54|-2.17|0.2377
72513224|NCT00839423|144556483|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.22|STANDARD_ERROR_OF_MEAN|0.67||0.7489|TWO_SIDED|95.0|-1.54|1.11||The hierarchical procedure meant that the above hypothesis was not tested since significance was not achieved for 10 mg at Week 1. A nominal p-value is provided.|ANCOVA|||"The statistical model was ANCOVA of the change from baseline in MADRS total score (FAS, LOCF) with treatment and centre as fixed factors and the baseline MADRS score as a covariate.~Null hypothesis: No difference between 5 mg Vortioxetine and placebo at Week 1."||1.11|-1.54|0.7489
72513225|NCT00839423|144556483|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.54|STANDARD_ERROR_OF_MEAN|0.67||0.4142|TWO_SIDED|95.0|-0.77|1.85||This treatment arm was not in the testing sequence. A nominal p-value is provided.|ANCOVA|||||1.85|-0.77|0.4142
72513226|NCT00839423|144556484|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.28|STANDARD_ERROR_OF_MEAN|1.22|<|0.0001|TWO_SIDED|95.0|-7.69|-2.88||A nominal p-value is provided.|ANCOVA|||||-2.88|-7.69|<0.0001
72513227|NCT00839423|144556484|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.33|STANDARD_ERROR_OF_MEAN|1.25|<|0.0001|TWO_SIDED|95.0|-7.79|-2.88||A nominal p-value is provided.|ANCOVA|||||-2.88|-7.79|<0.0001
72513228|NCT00839423|144556485|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.3|STANDARD_ERROR_OF_MEAN|1.0||0.0011|TWO_SIDED|95.0|-5.27|-1.33||A nominal p-value is provided.|ANCOVA|||||-1.33|-5.27|0.0011
72513229|NCT00839423|144556485|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.0|STANDARD_ERROR_OF_MEAN|1.02||0.0034|TWO_SIDED|95.0|-5.01|-1.0||A nominal p-value is provided.|ANCOVA|||||-1.00|-5.01|0.0034
72513230|NCT00839423|144556486|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9|STANDARD_ERROR_OF_MEAN|0.19|<|0.0001|TWO_SIDED|95.0|-1.28|-0.52||A nominal p-value is provided.|ANCOVA|||||-0.52|-1.28|<0.0001
72513231|NCT00839423|144556486|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.95|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001|TWO_SIDED|95.0|-1.34|-0.56||A nominal p-value is provided.|ANCOVA|||||-0.56|-1.34|<0.0001
72486149|NCT04667377|144500203|OTHER|"Missing body weight measurements were multiply imputed using MMRM with treatment, gender, baseline body weight as factors. Percentage change in body weight from baseline to Week 46 and Body weight loss ≥ 15% at Week 46 (yes/no) were derived per participant in each of the 1000 imputed datasets. Each dataset was analysed by a logistic regression. Multiple estimates from multiple imputation runs were summarised using Rubin's method."|Odds Ratio (OR)|11.79|||<|0.0001|TWO_SIDED|95.0|3.62|38.36||P-value is considered nominal.|Regression, Logistic|Logistic regression with treatment group and gender as factors and baseline body weight as a continuous linear covariate.|Odds ratio is calculated as BI 456906 / Placebo.|Logistic regression after multiple imputation. Analysis based on all available post-baseline body weight measurements (on-treatment (first intake of study drug until 28 days after last intake of study drug) and off-treatment), except those for participants who discontinued treatment early due to COVID-19. For these participants only on-treatment values were used.||38.36|3.62|<.0001
72486150|NCT04667377|144500203|OTHER|"Missing body weight measurements were multiply imputed using MMRM with treatment, gender, baseline body weight as factors. Percentage change in body weight from baseline to Week 46 and Body weight loss ≥ 15% at Week 46 (yes/no) were derived per participant in each of the 1000 imputed datasets. Each dataset was analysed by a logistic regression. Multiple estimates from multiple imputation runs were summarised using Rubin's method."|Odds Ratio (OR)|21.02|||<|0.0001|TWO_SIDED|95.0|6.47|68.28||P-value is considered nominal.|Regression, Logistic|Logistic regression with treatment group and gender as factors and baseline body weight as a continuous linear covariate.|Odds ratio is calculated as BI 456906 / Placebo.|Logistic regression after multiple imputation. Analysis based on all available post-baseline body weight measurements (on-treatment (first intake of study drug until 28 days after last intake of study drug) and off-treatment), except those for participants who discontinued treatment early due to COVID-19. For these participants only on-treatment values were used.||68.28|6.47|<.0001
72486151|NCT04667377|144500204|OTHER|MMRM with fixed effects for baseline body weight as a continuous linear covariate, and treatment, gender, visit, treatment by visit interaction and baseline by visit interaction as factors, using visit as repeated measures and an unstructured covariance matrix to model within subject measurements.|Difference of adjusted means|-4.53|STANDARD_ERROR_OF_MEAN|1.48||0.0025|TWO_SIDED|95.0|-7.44|-1.61||P-value is considered nominal.|Mixed Models Analysis|Kenward-Roger approximation was used to estimate the denominator degrees of freedom.|Difference was calculated as BI 456906 - placebo.|No formal hypotheses were tested.||-1.61|-7.44|0.0025
72486152|NCT04667377|144500204|OTHER|MMRM with fixed effects for baseline body weight as a continuous linear covariate, and treatment, gender, visit, treatment by visit interaction and baseline by visit interaction as factors, using visit as repeated measures and an unstructured covariance matrix to model within subject measurements.|Difference of adjusted means|-12.07|STANDARD_ERROR_OF_MEAN|1.46|<|0.0001|TWO_SIDED|95.0|-14.94|-9.19||P-value is considered nominal.|Mixed Models Analysis|Kenward-Roger approximation was used to estimate the denominator degrees of freedom.|Difference was calculated as BI 456906 - placebo.|No formal hypotheses were tested.||-9.19|-14.94|<.0001
72486153|NCT04667377|144500204|OTHER|MMRM with fixed effects for baseline body weight as a continuous linear covariate, and treatment, gender, visit, treatment by visit interaction and baseline by visit interaction as factors, using visit as repeated measures and an unstructured covariance matrix to model within subject measurements.|Difference of adjusted means|-12.96|STANDARD_ERROR_OF_MEAN|1.47|<|0.0001|TWO_SIDED|95.0|-15.85|-10.07||P-value is considered nominal.|Mixed Models Analysis|Kenward-Roger approximation was used to estimate the denominator degrees of freedom.|Difference was calculated as BI 456906 - placebo at week 46.|No formal hypotheses were tested.||-10.07|-15.85|<.0001
72486154|NCT04667377|144500204|OTHER|MMRM with fixed effects for baseline body weight as a continuous linear covariate, and treatment, gender, visit, treatment by visit interaction and baseline by visit interaction as factors, using visit as repeated measures and an unstructured covariance matrix to model within subject measurements.|Difference of adjusted means|-15.78|STANDARD_ERROR_OF_MEAN|1.47|<|0.0001|TWO_SIDED|95.0|-18.67|-12.9||P-value is considered nominal.|Mixed Models Analysis|Kenward-Roger approximation was used to estimate the denominator degrees of freedom.|Difference was calculated as BI 456906 - placebo at week 46.|No formal hypotheses were tested.||-12.90|-18.67|<.0001
72486155|NCT04667377|144500205|OTHER|MMRM with fixed effects for baseline waist circumference as a continuous linear covariate, and treatment, gender, visit, treatment by visit interaction and baseline by visit interaction as factors, using visit as repeated measures and an unstructured covariance matrix to model within subject measurements.|Difference of adjusted means|-4.36|STANDARD_ERROR_OF_MEAN|1.71||0.0116|TWO_SIDED|95.0|-7.74|-0.98||P-value is considered nominal.|Mixed Models Analysis|Kenward-Roger approximation was used to estimate the denominator degrees of freedom.|Difference was calculated as BI 456906 - placebo.|No formal hypotheses were tested.||-0.98|-7.74|0.0116
72486156|NCT04667377|144500205|OTHER|MMRM with fixed effects for baseline waist circumference as a continuous linear covariate, and treatment, gender, visit, treatment by visit interaction and baseline by visit interaction as factors, using visit as repeated measures and an unstructured covariance matrix to model within subject measurements.|Difference of adjusted means|-11.03|STANDARD_ERROR_OF_MEAN|1.71|<|0.0001|TWO_SIDED|95.0|-14.39|-7.66||P-value is considered nominal.|Mixed Models Analysis|Kenward-Roger approximation was used to estimate the denominator degrees of freedom.|Difference was calculated as BI 456906 - placebo.|No formal hypotheses were tested.||-7.66|-14.39|<.0001
72513232|NCT00839423|144556487|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.58|STANDARD_ERROR_OF_MEAN|0.16||0.0003|TWO_SIDED|95.0|-0.9|-0.27||A nominal p-value is provided.|ANCOVA|||||-0.27|-0.90|0.0003
72513233|NCT00839423|144556487|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.16||0.0003|TWO_SIDED|95.0|-0.92|-0.27||A nominal p-value is provided.|ANCOVA|||||-0.27|-0.92|0.0003
72513234|NCT00839423|144556488|SUPERIORITY_OR_OTHER||Difference %|21.9||||0.002|TWO_SIDED|95.0|8.89|34.92||A nominal p-value is provided.|Fisher Exact|||||34.92|8.89|0.002
72567750|NCT00586482|144667090|SUPERIORITY_OR_OTHER|||||||0.12|TWO_SIDED||||||t-test, 2 sided|||A two-sided p value of less than or equal to 0.05 was considered statistically significant.||||0.12
72513235|NCT00839423|144556488|SUPERIORITY_OR_OTHER||Difference %|23.34||||0.001|TWO_SIDED|95.0|10.05|36.43||A nominal p-value is provided.|Fisher Exact|||||36.43|10.05|0.001
72567751|NCT00586482|144667091|SUPERIORITY_OR_OTHER|||||||0.23|||||||Fisher Exact|||||||0.23
72567752|NCT00586482|144667092|SUPERIORITY_OR_OTHER|||||||0.29|||||||t-test, 2 sided|||||||0.29
72567753|NCT00586482|144667093|SUPERIORITY_OR_OTHER|||||||0.93|||||||t-test, 2 sided|||||||0.93
72486157|NCT04667377|144500205|OTHER|MMRM with fixed effects for baseline waist circumference as a continuous linear covariate, and treatment, gender, visit, treatment by visit interaction and baseline by visit interaction as factors, using visit as repeated measures and an unstructured covariance matrix to model within subject measurements.|Difference of adjusted means|-11.0|STANDARD_ERROR_OF_MEAN|1.69|<|0.0001|TWO_SIDED|95.0|-14.33|-7.67||P-value is considered nominal.|Mixed Models Analysis|Kenward-Roger approximation was used to estimate the denominator degrees of freedom.|Difference was calculated as BI 456906 - placebo.|No formal hypotheses were tested.||-7.67|-14.33|<.0001
72486158|NCT04667377|144500205|OTHER|MMRM with fixed effects for baseline waist circumference as a continuous linear covariate, and treatment, gender, visit, treatment by visit interaction and baseline by visit interaction as factors, using visit as repeated measures and an unstructured covariance matrix to model within subject measurements.|Difference of adjusted means|-12.05|STANDARD_ERROR_OF_MEAN|1.69|<|0.0001|TWO_SIDED|95.0|-15.39|-8.71||P-value is considered nominal.|Mixed Models Analysis|Kenward-Roger approximation was used to estimate the denominator degrees of freedom.|Difference was calculated as BI 456906 - placebo.|No formal hypotheses were tested.||-8.71|-15.39|<.0001
72402750|NCT01480076|144311692|SUPERIORITY_OR_OTHER|||||||0.0179|||||||mixed effect model|||Month 6, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0179
72486159|NCT04667377|144500206|OTHER|MMRM with fixed effects for baseline systolic blood pressure as a continuous linear covariate, and treatment, gender, visit, treatment by visit interaction and baseline by visit interaction as factors, using visit as repeated measures and an unstructured covariance matrix to model within subject measurements.|Difference of adjusted means|-3.73|STANDARD_ERROR_OF_MEAN|2.08||0.0733|TWO_SIDED|95.0|-7.82|0.35||P-value is considered nominal.|Mixed Models Analysis|Kenward-Roger approximation was used to estimate the denominator degrees of freedom.|Difference was calculated as BI 456906 - placebo.|No formal hypotheses were tested.||0.35|-7.82|0.0733
72486160|NCT04667377|144500206|OTHER|MMRM with fixed effects for baseline systolic blood pressure as a continuous linear covariate, and treatment, gender, visit, treatment by visit interaction and baseline by visit interaction as factors, using visit as repeated measures and an unstructured covariance matrix to model within subject measurements.|Difference of adjusted means|-5.62|STANDARD_ERROR_OF_MEAN|2.08|<|0.0072|TWO_SIDED|95.0|-9.71|1.53||P-value is considered nominal.|Mixed Models Analysis|Kenward-Roger approximation was used to estimate the denominator degrees of freedom.|Difference was calculated as BI 456906 - placebo.|No formal hypotheses were tested.||1.53|-9.71|<.0072
72486161|NCT04667377|144500206|OTHER|MMRM with fixed effects for baseline systolic blood pressure as a continuous linear covariate, and treatment, gender, visit, treatment by visit interaction and baseline by visit interaction as factors, using visit as repeated measures and an unstructured covariance matrix to model within subject measurements.|Difference of adjusted means|-6.2|STANDARD_ERROR_OF_MEAN|2.05||0.0027|TWO_SIDED|95.0|-10.23|-2.17||P-value is considered nominal.|Mixed Models Analysis|Kenward-Roger approximation was used to estimate the denominator degrees of freedom.|Difference was calculated as BI 456906 - placebo.|No formal hypotheses were tested.||-2.17|-10.23|0.0027
72513236|NCT00839423|144556489|SUPERIORITY_OR_OTHER||Difference %|22.41||||0.001|TWO_SIDED|95.0|9.74|35.07||A nominal p-value is provided.|Fisher Exact|||||35.07|9.74|0.001
72513237|NCT00839423|144556489|SUPERIORITY_OR_OTHER||Difference %|22.33||||0.001|TWO_SIDED|95.0|9.39|35.28||A nominal p-value is provided.|Fisher Exact|||||35.28|9.39|0.001
72513238|NCT04348656|144556490|SUPERIORITY||Risk Ratio (RR)|1.16||||0.18|TWO_SIDED|95.0|0.94|1.43|||wald test|||||1.43|0.94|0.18
72513239|NCT04348656|144556491|SUPERIORITY||Hazard Ratio (HR)|1.14||||0.3|TWO_SIDED|95.0|0.89|1.47|||Regression, Cox|||||1.47|0.89|0.30
72513240|NCT04348656|144556492|SUPERIORITY||Mean Difference (Final Values)|-0.6||||0.41|TWO_SIDED|95.0|-2.1|0.7|||t-test, 2 sided|bootstrap estimates based on resampling process|bootstrap estimates based on resampling process|||0.7|-2.1|0.41
72513241|NCT04348656|144556493|SUPERIORITY||Risk Ratio (RR)|1.12||||0.4|TWO_SIDED|95.0|0.86|1.46|||wald test|||||1.46|0.86|0.40
72513242|NCT04348656|144556494|SUPERIORITY||Mean Difference (Final Values)|0.7||||0.22|TWO_SIDED|95.0|-0.3|1.7|||t-test, 2 sided|||||1.7|-0.3|0.22
72513243|NCT04348656|144556495|SUPERIORITY||Risk Ratio (RR)|0.83||||0.72|TWO_SIDED|95.0|0.31|2.27|||t-test, 2 sided|bootstrap estimates based on resampling process|bootstrap estimates based on resampling process|||2.27|0.31|0.72
72513244|NCT04348656|144556498|SUPERIORITY||Risk Ratio (RR)|1.13||||0.33|TWO_SIDED|95.0|0.88|1.45|||wald test|||||1.45|0.88|0.33
72567754|NCT00586482|144667094|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||||||1.0
72513245|NCT04348656|144556499|SUPERIORITY||Hazard Ratio (HR)|1.02||||0.91|TWO_SIDED|95.0|0.76|1.35|||Regression, Cox|competing risk analysis|competing risk analysis|||1.35|0.76|0.91
72513246|NCT04348656|144556500|SUPERIORITY||Hazard Ratio (HR)|0.91||||0.18|TWO_SIDED|95.0|0.8|1.04|||Regression, Cox|||||1.04|0.80|0.18
72513247|NCT04348656|144556501|SUPERIORITY||Risk Ratio (RR)|1.53||||0.03|TWO_SIDED|95.0|1.04|2.26|||wald test|||||2.26|1.04|0.03
72513248|NCT04348656|144556501|SUPERIORITY||Hazard Ratio (HR)|1.7||||0.02|TWO_SIDED|95.0|1.08|2.69|||Regression, Cox|competing risk analysis|competing risk analysis|The cumulative incidence of Grade 3 and 4 serious AEs is described as a hazard ratio.||2.69|1.08|0.02
72513249|NCT04348656|144556503|SUPERIORITY||Risk Ratio (RR)|1.27||||0.03|TWO_SIDED|95.0|1.02|1.57|||wald test|||||1.57|1.02|0.03
72513250|NCT04348656|144556506|OTHER|Incremental cost per quality-adjusted life day gained (ICER)- this is a summary measure of the cost-effectiveness of the intervention, compared to the control group. This is calculated using the cost (derived from cost of the intervention and cost of hospital stay based on the payer's perspective) per patient and the quality-adjusted life days calculated using the EQ-5D-5L results.|ICER (CAD)|-44623.01|||||TWO_SIDED|95.0|-525369.24|436123.22|||||ICER is reported in Canadian dollars. 95% CI is calculated by 1000 bootstrap sampling using bias-corrected accelerated method.|||436123.22|-525369.24|
72513251|NCT03607838|144556527|SUPERIORITY||Mean Difference (Final Values)|-7.5|STANDARD_ERROR_OF_MEAN|3.35||0.0263|TWO_SIDED|95.0|-14.1|-0.9|||Mixed Models Analysis|||||-0.9|-14.1|0.0263
72402751|NCT01480076|144311692|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 6, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
72402752|NCT01480076|144311692|SUPERIORITY_OR_OTHER|||||||0.6911|||||||mixed effect model|||Month 6, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.6911
72402753|NCT01480076|144311692|SUPERIORITY_OR_OTHER||difference of LS means|10.8|STANDARD_ERROR_OF_MEAN|2.31|<|0.0001|TWO_SIDED||||||mixed effect model|||Month 6, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
72486162|NCT04667377|144500206|OTHER|MMRM with fixed effects for baseline systolic blood pressure as a continuous linear covariate, and treatment, gender, visit, treatment by visit interaction and baseline by visit interaction as factors, using visit as repeated measures and an unstructured covariance matrix to model within subject measurements.|Difference of adjusted means|-6.16|STANDARD_ERROR_OF_MEAN|2.08||0.0033|TWO_SIDED|95.0|-10.25|-2.06||P-value is considered nominal.|Mixed Models Analysis|Kenward-Roger approximation was used to estimate the denominator degrees of freedom.|Difference was calculated as BI 456906 - placebo.|No formal hypotheses were tested.||-2.06|-10.25|0.0033
72486163|NCT04667377|144500207|OTHER|MMRM with fixed effects for baseline diastolic blood pressure as a continuous linear covariate, and treatment, gender, visit, treatment by visit interaction and baseline by visit interaction as factors, using visit as repeated measures and an unstructured covariance matrix to model within subject measurements.|Difference of adjusted means|-1.44|STANDARD_ERROR_OF_MEAN|1.26||0.2569|TWO_SIDED|95.0|-3.92|1.05||P-value is considered nominal.|Mixed Models Analysis|Kenward-Roger approximation was used to estimate the denominator degrees of freedom.|Difference was calculated as BI 456906 - placebo.|No formal hypotheses were tested.||1.05|-3.92|0.2569
72486164|NCT04667377|144500207|OTHER|MMRM with fixed effects for baseline diastolic blood pressure as a continuous linear covariate, and treatment, gender, visit, treatment by visit interaction and baseline by visit interaction as factors, using visit as repeated measures and an unstructured covariance matrix to model within subject measurements.|Difference of adjusted means|-2.49|STANDARD_ERROR_OF_MEAN|1.26||0.0495|TWO_SIDED|95.0|-4.97|0.0||P-value is considered nominal.|Mixed Models Analysis|Kenward-Roger approximation was used to estimate the denominator degrees of freedom.|Difference was calculated as BI 456906 - placebo.|No formal hypotheses were tested.||-0.00|-4.97|0.0495
72486165|NCT04667377|144500207|OTHER|MMRM with fixed effects for baseline diastolic blood pressure as a continuous linear covariate, and treatment, gender, visit, treatment by visit interaction and baseline by visit interaction as factors, using visit as repeated measures and an unstructured covariance matrix to model within subject measurements.|Difference of adjusted means|-2.44|STANDARD_ERROR_OF_MEAN|1.24||0.0506|TWO_SIDED|95.0|-4.9|0.01||P-value is considered nominal.|Mixed Models Analysis|Kenward-Roger approximation was used to estimate the denominator degrees of freedom.|Difference was calculated as BI 456906 -placebo.|No formal hypotheses were tested.||0.01|-4.90|0.0506
72486166|NCT04667377|144500207|OTHER|MMRM with fixed effects for baseline diastolic blood pressure as a continuous linear covariate, and treatment, gender, visit, treatment by visit interaction and baseline by visit interaction as factors, using visit as repeated measures and an unstructured covariance matrix to model within subject measurements.|Difference of adjusted means|-2.93|STANDARD_ERROR_OF_MEAN|1.25||0.0202|TWO_SIDED|95.0|-5.4|-0.46||P-value is considered nominal.|Mixed Models Analysis|Kenward-Roger approximation was used to estimate the denominator degrees of freedom.|Difference was calculated as BI 456906 - placebo.|No formal hypotheses were tested.||-0.46|-5.40|0.0202
72513252|NCT03607838|144556528|SUPERIORITY||Mean Difference (Final Values)|-6.5|STANDARD_ERROR_OF_MEAN|3.4||0.0558|TWO_SIDED|95.0|-13.2|0.2||To control family-wise error rate for multiple tests of the primary and key secondary endpoints, serial gatekeeping testing algorithm was used.|Mixed Models Analysis|||||0.2|-13.2|0.0558
72513253|NCT03607838|144556529|SUPERIORITY||Mean Difference (Final Values)|-25.8|STANDARD_ERROR_OF_MEAN|15.24||0.092|TWO_SIDED|95.0|-55.7|4.2||To control family-wise error rate for multiple tests of the primary and key secondary endpoints, serial gatekeeping testing algorithm was used.|Mixed Models Analysis|||||4.2|-55.7|0.0920
72513254|NCT03607838|144556530|SUPERIORITY||Mean Difference (Final Values)|-4.2|STANDARD_ERROR_OF_MEAN|1.95||0.0336|TWO_SIDED|95.0|-8.0|-0.3||To control family-wise error rate for multiple tests of the primary and key secondary endpoints, serial gatekeeping testing algorithm was used.|Mixed Models Analysis|||||-0.3|-8.0|0.0336
72513255|NCT00423735|144556647|SUPERIORITY|||||||0.99|||||||Fisher Exact|2-sided test||||||0.99
72513256|NCT01722487|144556655|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.16|||<|0.0001|TWO_SIDED|95.0|0.09|0.28|||Log Rank|||||0.28|0.09|<0.0001
72567755|NCT00856973|144667138|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|7.33|STANDARD_ERROR_OF_MEAN|3.91|>|0.05|TWO_SIDED|97.5|-5.17|19.83|||ANCOVA|Bonferroni adjustment was use for multiple comparisons|Difference calculated as Eszopiclone minus placebo|This endpoint was analyzed using ANCOVA with treatment group (pooled low dose eszopiclone, pooled high dose eszopiclone, and placebo) as a fixed effect and the baseline value as a covariate. Contrast statements were used to perform pairwise comparisons of the eszopiclone treatment groups to placebo. A Bonferroni adjustment was used for the 2 pairwise comparisons. Least squares means and the standard errors were presented for each treatment grou||19.83|-5.17|>0.05
72513257|NCT01722487|144556656|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.16||||0.001|TWO_SIDED|95.0|0.05|0.56|||Log Rank|||||0.56|0.05|0.0010
72513258|NCT01722487|144556657|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
72513259|NCT01722487|144556658|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Chi-squared|||||||<0.0001
72513260|NCT01722487|144556659|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Chi-squared|||||||<0.0001
72513261|NCT01722487|144556660|SUPERIORITY_OR_OTHER|||||||0.0009|||||||Chi-squared|||||||.0009
72513262|NCT01722487|144556661|SUPERIORITY_OR_OTHER|||||||0.0054|||||||Chi-squared|||||||.0054
72513263|NCT03025217|144556669|OTHER||Cohen's d|0.33||||0.095|TWO_SIDED||||||t-test, 2 sided|||||||.095
72513264|NCT03025217|144556670|OTHER||Cohen's d|0.75||||0.001|TWO_SIDED||||||t-test, 2 sided|||||||.001
72513265|NCT04096326|144556676|SUPERIORITY||Rate difference|40.6||||0.0096|TWO_SIDED|95.0|23.6|57.6||P-value was based on Cochran-Mantel-Haenszel (CMH) tests stratified by baseline GL severity at maximum frown to compare each AGN-151586 study intervention group versus placebo for each cohort.|Cochran-Mantel-Haenszel|||||57.6|23.6|0.0096
72513266|NCT04096326|144556676|SUPERIORITY||Rate difference|46.4||||0.0094|TWO_SIDED|95.0|28.0|64.9||P-value was based on CMH tests stratified by baseline GL severity at maximum frown to compare each AGN-151586 study intervention group versus placebo for each cohort.|Cochran-Mantel-Haenszel|||||64.9|28.0|0.0094
72513267|NCT04096326|144556676|SUPERIORITY||Rate difference|52.2||||0.0044|TWO_SIDED|95.0|23.6|80.8||P-value was based on CMH tests stratified by baseline GL severity at maximum frown to compare each AGN-151586 study intervention group versus placebo for each cohort.|Cochran-Mantel-Haenszel|||||80.8|23.6|0.0044
72513268|NCT04096326|144556676|SUPERIORITY||Rate difference|63.3||||0.0026|TWO_SIDED|95.0|35.2|91.5||P-value was based on CMH tests stratified by baseline GL severity at maximum frown to compare each AGN-151586 study intervention group versus placebo for each cohort.|Cochran-Mantel-Haenszel|||||91.5|35.2|0.0026
72513269|NCT04096326|144556676|SUPERIORITY||Rate difference|85.7||||0|TWO_SIDED|95.0|64.2|100.0||P-value was based on CMH tests stratified by baseline GL severity at maximum frown to compare each AGN-151586 study intervention group versus placebo for each cohort.|Cochran-Mantel-Haenszel|||||100.0|64.2|0.0000
72513270|NCT00194025|144556682|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 1 sided|||The 1 sided t-test was applied to the scores at baseline vs. the scores at 12 weeks.||||<0.001
72513271|NCT00194025|144556683|SUPERIORITY_OR_OTHER|||||||0.585||95.0|||||t-test, 1 sided|||The 1 sided t-test was applied to the scores at baseline vs. the scores at 12 weeks.||||0.585
72513272|NCT00194025|144556684|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 1 sided|||The 1 sided t-test was applied to the scores at baseline vs. the scores at 12 weeks.||||<0.001
72513273|NCT00194025|144556685|SUPERIORITY_OR_OTHER|||||||0.017||95.0|||||t-test, 1 sided|||The 1 sided t-test was applied to the scores at baseline vs. the scores at 12 weeks.||||0.017
72513274|NCT00194025|144556686|SUPERIORITY_OR_OTHER|||||||0.027||95.0|||||t-test, 1 sided|||The 1 sided t-test was applied to the scores at baseline vs. the scores at 12 weeks.||||0.027
72513275|NCT00194025|144556687|SUPERIORITY_OR_OTHER|||||||0.569||95.0|||||t-test, 1 sided|||The 1 sided t-test was applied to the scores at baseline vs. the scores at 12 weeks.||||0.569
72513276|NCT00194025|144556688|SUPERIORITY_OR_OTHER|||||||0.038||95.0|||||t-test, 1 sided|||The 1 sided t-test was applied to the scores at baseline vs. the scores at 12 weeks.||||0.038
72513277|NCT00194025|144556689|SUPERIORITY_OR_OTHER|||||||0.199||95.0|||||t-test, 1 sided|||The 1 sided t-test was applied to the scores at baseline vs. the scores at 12 weeks.||||0.199
72513278|NCT00194025|144556690|SUPERIORITY_OR_OTHER|||||||0.21||95.0|||||t-test, 2 sided|||The t-test was applied to the values at baseline vs. the values at 12 weeks.||||0.21
72513279|NCT04804033|144556696|OTHER||Difference in least square mean (LSM)|-1.4|||||TWO_SIDED|97.5|-2.72|-0.12|||||Linear mixed effects model with repeated measures with number of total migraine days per month in the OP as covariate, treatment group, randomization stratum, month, month-by treatment group interaction as fixed effects using migraine analysis set.|||-0.12|-2.72|
72513280|NCT04804033|144556696|OTHER||Difference in LSM|-0.7|||||TWO_SIDED|97.5|-2.07|0.69|||||Linear mixed effects model with repeated measures with number of total migraine days per month in the OP as covariate, treatment group, randomization stratum, month, month-by treatment group interaction as fixed effects using migraine analysis set.|||0.69|-2.07|
72513281|NCT04804033|144556697|OTHER||Difference in percentage|16.6|||||TWO_SIDED|97.5|4.4|28.8|||||Stratified by randomization stratum using Mantel-Haenszel risk estimation.|||28.8|4.4|
72513282|NCT04804033|144556697|OTHER||Difference in percentage|6.6|||||TWO_SIDED|97.5|-5.6|18.9|||||Stratified by randomization stratum using Mantel-Haenszel risk estimation.|||18.9|-5.6|
72513283|NCT04804033|144556698|OTHER||Difference in LSM|-1.0|||||TWO_SIDED|97.5|-2.68|0.58|||||Linear mixed effects model with repeated measures with number of total migraine days per month in the OP as covariate, treatment group, randomization stratum, month, month-by treatment group interaction as fixed effects using migraine analysis set.|||0.58|-2.68|
72513284|NCT04804033|144556698|OTHER||Difference in LSM|-0.4|||||TWO_SIDED|97.5|-2.1|1.31|||||Linear mixed effects model with repeated measures with number of total migraine days per month in the OP as covariate, treatment group, randomization stratum, month, month-by treatment group interaction as fixed effects using migraine analysis set.|||1.31|-2.10|
72513285|NCT04804033|144556699|OTHER||Difference in LSM|-1.8|||||TWO_SIDED|97.5|-3.16|-0.42|||||Linear mixed effects model with repeated measures with number of total migraine days per month in the OP as covariate, treatment group, randomization stratum, month, month-by treatment group interaction as fixed effects using migraine analysis set.|||-0.42|-3.16|
72513286|NCT04804033|144556699|OTHER||Difference in LSM|-1.2|||||TWO_SIDED|97.5|-2.53|0.22|||||Linear mixed effects model with repeated measures with number of total migraine days per month in the OP as covariate, treatment group, randomization stratum, month, month-by treatment group interaction as fixed effects using migraine analysis set.|||0.22|-2.53|
72513287|NCT04804033|144556700|OTHER||Difference in LSM|-0.8|||||TWO_SIDED|97.5|-1.59|0.05|||||Linear mixed effects model with repeated measures with number of total migraine days per month in the OP as covariate, treatment group, randomization stratum, month, month-by treatment group interaction as fixed effects using migraine analysis set.|||0.05|-1.59|
72513288|NCT04804033|144556700|OTHER||Difference in LSM|-0.2|||||TWO_SIDED|97.5|-1.06|0.74|||||Linear mixed effects model with repeated measures with number of total migraine days per month in the OP as covariate, treatment group, randomization stratum, month, month-by treatment group interaction as fixed effects using migraine analysis set.|||0.74|-1.06|
72513289|NCT04804033|144556701|OTHER||Difference in LSM|3.9|||||TWO_SIDED|97.5|-1.5|9.39|||||Linear regression model had the following variables: Week 12 change from baseline in domain score as the dependent variable; baseline domain score as a covariate; treatment group and randomization stratum as fixed effects.|||9.39|-1.50|
72486167|NCT01011439|144500208|SUPERIORITY||Single proportion|0.44|||<|0.001|TWO_SIDED|95.0|0.31|0.59|||Fisher Exact|||H0:p\</=17% vs. H1:p\>17%, with an interesting PFS-3 rate of 33% or higher; Power=80%; Alpha(1-sided)=5%, 54 evaluable patients are required for a Simon optimal two stage design trial. If at least 4 successes among the first 17 evaluable patients are observed in the 1st stage, patients' enrollment proceed up to the final analysis where at least 14/54 successes (PFS-3 rate ≥ 25.9%) must be required to reject the null hypothesis.||0.59|0.31|<0.001
72402754|NCT01480076|144311692|SUPERIORITY_OR_OTHER||difference of LS means|7.1|STANDARD_ERROR_OF_MEAN|3.85||0.0666|TWO_SIDED||||||mixed effect model|||Month 6, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0666
72486168|NCT02606461|144500259|SUPERIORITY||Hazard Ratio (HR)|0.7026||||0.0114|TWO_SIDED|95.0|0.5191|0.9509|||Log Rank|||||0.9509|0.5191|0.0114
72486169|NCT02606461|144500261|SUPERIORITY||Hazard Ratio, log|1.1521||||0.6051|TWO_SIDED|95.0|0.5357|2.4778|||Log Rank|||||2.4778|0.5357|0.6051
72486170|NCT04422990|144500297|NON_INFERIORITY|Noninferiority in mean CLCDVA was declared if the upper confidence limit was less than 0.10 logMAR.|Least squares mean difference|0.0|||||TWO_SIDED|95.0|-0.01|0.01||Since a noninferiority hypothesis is being tested, a p-value is not applicable. Confidence limit is being reported and compared to the noninferiority margin.|Mixed effects repeated measures model||Least squares mean difference (LID018869 minus Biofinity).|||0.01|-0.01|
72486171|NCT04422990|144500298|NON_INFERIORITY|Proportion of subjects was used for the statistical analysis. Noninferiority in proportion of subjects achieving CLCDVA 20/20 or better in each eye was declared if the lower confidence limit was greater than -0.10.|Difference in proportion|-0.01|||||TWO_SIDED|95.0|-0.04|0.02||Since a noninferiority hypothesis is being tested, a p-value is not applicable. Confidence limit is being reported and compared to the noninferiority margin.|Generalized linear mixed model||Lens difference (LID018869 minus Biofinity)|||0.02|-0.04|
72486172|NCT00240981|144500309|SUPERIORITY_OR_OTHER||Mean Difference (Net)|129.8||||0.003|TWO_SIDED|95.0|43.9|215.6||The unadjusted analysis using two-sample Student's t-tests of equal change in the trial groups, allowing unequal variance.|t-test, 2 sided|||||215.6|43.9|0.003
72486173|NCT00240981|144500309|SUPERIORITY_OR_OTHER||Mean Difference (Net)|129.4||||0.004|TWO_SIDED|95.0|43.5|215.4||Adjusted analysis used multiple linear regression, with adjustment for baseline total score on the Short Physical Performance Battery, and self-report of limitations in mobility.|Regression, Linear|||||215.4|43.5|0.004
72486174|NCT00240981|144500310|SUPERIORITY_OR_OTHER||Mean Difference (Net)|34.5||||0.002|TWO_SIDED|95.0|13.2|55.8||Unadjusted|t-test, 2 sided|||||55.8|13.2|0.002
72513290|NCT04804033|144556701|OTHER||Difference in LSM|0.1|||||TWO_SIDED|97.5|-5.66|5.86|||||Linear regression model had the following variables: Week 12 change from baseline in domain score as the dependent variable; baseline domain score as a covariate; treatment group and randomization stratum as fixed effects.|||5.86|-5.66|
72567756|NCT00856973|144667138|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|2.21|STANDARD_ERROR_OF_MEAN|3.91|>|0.05|TWO_SIDED|97.5|-10.23|14.65|||ANCOVA|||This endpoint was analyzed using ANCOVA with treatment group (pooled low dose eszopiclone, pooled high dose eszopiclone, and placebo) as a fixed effect and the baseline value as a covariate. Contrast statements were used to perform pairwise comparisons of the eszopiclone treatment groups to placebo. A Bonferroni adjustment was used for the 2 pairwise comparisons. Least squares means and the standard errors were presented for each treatment group.||14.65|-10.23|>0.05
72486175|NCT00240981|144500310|SUPERIORITY_OR_OTHER||Mean Difference (Net)|34.5||||0.002|TWO_SIDED|95.0|13.1|56.2||Adjusted|Regression, Linear|||||56.2|13.1|0.002
72486176|NCT00240981|144500311|SUPERIORITY_OR_OTHER||Mean Difference (Net)|8.7||||0.34|TWO_SIDED|95.0|-9.2|26.7||Unadjusted|t-test, 2 sided|||||26.7|-9.2|0.34
72567757|NCT03623386|144667182|SUPERIORITY|||||||0.981|||||||Wilcoxon (Mann-Whitney)|||||||0.981
72486177|NCT00240981|144500311|SUPERIORITY_OR_OTHER||Mean Difference (Net)|8.1||||0.37|TWO_SIDED|95.0|-9.9|26.2||Adjusted.|Regression, Linear|||||26.2|-9.9|0.37
72486178|NCT00240981|144500312|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.27||||0.69|TWO_SIDED|95.0|-1.1|1.7||Unadjusted|t-test, 2 sided|||||1.7|-1.1|0.69
72486179|NCT00240981|144500312|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.26||||0.71|TWO_SIDED|95.0|-1.1|1.7||Adjusted.|Regression, Linear|||||1.7|-1.1|0.71
72486180|NCT00240981|144500313|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.05||||0.26|TWO_SIDED|95.0|-0.035|0.135||Unadjusted.|t-test, 2 sided|||||0.135|-0.035|0.26
72486181|NCT00240981|144500313|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.048||||0.27|TWO_SIDED|95.0|-0.037|0.133||Adjusted|Regression, Linear|||||0.133|-0.037|0.27
72486182|NCT00240981|144500314|SUPERIORITY_OR_OTHER||Mean Difference (Net)|30.2||||0.05|TWO_SIDED|95.0|0.3|60.1||Unadjusted.|t-test, 2 sided|||||60.1|0.3|0.05
72486183|NCT00240981|144500314|SUPERIORITY_OR_OTHER||Mean Difference (Net)|29.7||||0.05|TWO_SIDED|95.0|0.2|59.3||Adjusted|Regression, Linear|||||59.3|0.2|0.05
72486184|NCT00240981|144500316|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.8||||0.2|TWO_SIDED|95.0|1.2|2.5||Month 3 Measures|t-test, 2 sided|||||2.5|1.2|0.2
72486185|NCT00240981|144500316|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.5|||<|0.0001|TWO_SIDED|95.0|0.4|2.2||Month 6 Measures|t-test, 2 sided|||||2.2|0.4|<.0001
72486186|NCT00240981|144500317|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.7||||0.002|TWO_SIDED|95.0|-2.7|-0.6||3 Months Measures|t-test, 2 sided|||||-0.6|-2.7|0.002
72486187|NCT00240981|144500317|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.0|||<|0.0001|TWO_SIDED|95.0|-2.8|-1.2||6 Month Measures|t-test, 2 sided|||||-1.2|-2.8|<.0001
72486188|NCT00240981|144500318|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.074||||0.24|TWO_SIDED|95.0|-0.05|0.19||Unadjusted.|t-test, 2 sided|||||0.19|-0.05|0.24
72486189|NCT00240981|144500318|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.09||||0.14|TWO_SIDED|95.0|-0.03|0.209||Adjusted.|Regression, Linear|||||0.209|-0.030|0.14
72486190|NCT00766090|144500319|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.108|||<|0.001|TWO_SIDED|95.0|0.064|0.153|||ANCOVA|||||0.153|0.064|<0.001
72486191|NCT00766090|144500319|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.098|||<|0.001|TWO_SIDED|95.0|0.054|0.142|||ANCOVA|||||0.142|0.054|<0.001
72486192|NCT00766090|144500319|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.087||||0.02|TWO_SIDED|95.0|0.014|0.161|||ANCOVA|||||0.161|0.014|0.020
72402755|NCT01480076|144311692|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 9, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
72402756|NCT01480076|144311692|SUPERIORITY_OR_OTHER|||||||0.0158|||||||mixed effect model|||Month 9, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0158
72402757|NCT01480076|144311692|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 9, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
72402758|NCT01480076|144311692|SUPERIORITY_OR_OTHER|||||||0.6684|||||||mixed effect model|||Month 9, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.6684
72402759|NCT01480076|144311692|SUPERIORITY_OR_OTHER||difference of LS means|11.6|STANDARD_ERROR_OF_MEAN|2.49|<|0.0001|TWO_SIDED||||||mixed effect model|||Month 9, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
72486193|NCT00766090|144500319|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was demonstrated if the lower limit of the confidence interval (0.025, 1-sided significance level) for the mean difference in trough FEV1 of FF 200 µg OD versus FF 100 µg BID was greater than -110 milliliters.|Mean Difference (Final Values)|0.011||||0.641|TWO_SIDED|95.0|-0.035|0.056|||ANCOVA|||||0.056|-0.035|0.641
72486194|NCT00766090|144500319|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.132|||<|0.001|TWO_SIDED|95.0|0.059|0.205|||ANCOVA|||||0.205|0.059|<0.001
72486195|NCT01750931|144500336|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence is established when 90% Confidence Interval falls within 80-125%.|Percent ratio|102.45||||0.4396|TWO_SIDED|95.0|99.4|105.59|||ANOVA|||||105.59|99.40|0.4396
72486196|NCT01750931|144500338|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence is established when 90% Confidence Interval falls within 80-125%.|Percent ratio|105.02||||0.9712|TWO_SIDED|95.0|99.69|110.63|||ANOVA||Comparison of AUC0-t between group GSK-meloxicam 15 mg and Mobic-meloxicam 15 mg|||110.63|99.69|0.9712
72567758|NCT03623386|144667183|SUPERIORITY|||||||0.481|||||||Wilcoxon (Mann-Whitney)|||||||0.481
72402760|NCT01480076|144311692|SUPERIORITY_OR_OTHER||difference of LS means|10.5|STANDARD_ERROR_OF_MEAN|4.28||0.0141|TWO_SIDED||||||mixed effect model|||Month 9, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0141
72402761|NCT01480076|144311692|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 12, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
72486197|NCT01750931|144500338|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence is established when 90% Confidence Interval falls within 80-125%.|Percent ratio|102.31||||0.9951|TWO_SIDED|95.0|99.05|105.69|||ANOVA||Comparison of AUC0-infinity between group GSK-meloxicam 15 mg and Mobic-meloxicam 15 mg|||105.69|99.05|0.9951
72486198|NCT02871778|144500347|SUPERIORITY||Least Square (LS) Mean difference|1.519||||0.0437|TWO_SIDED|95.0|0.044|2.995|||Mixed-effects Model|||||2.995|0.044|0.0437
72486199|NCT02871778|144500347|SUPERIORITY||LS Mean difference|0.04||||0.9755|TWO_SIDED|95.0|-2.509|2.589|||Mixed-effects Model|||||2.589|-2.509|0.9755
72486200|NCT02871778|144500347|SUPERIORITY||LS Mean difference|2.318||||0.0731|TWO_SIDED|95.0|-0.22|4.856|||Mixed-effects Model|||||4.856|-0.22|0.0731
72567759|NCT03623386|144667184|SUPERIORITY||||||>|0.05|||||||ANOVA|||Testing for main effects (group), time effect and the interaction of group and time.||||>0.05
72486201|NCT02871778|144500347|SUPERIORITY||LS Mean Difference|0.799||||0.5373|TWO_SIDED|95.0|-1.751|3.348|||Mixed-effects Model|||||3.348|-1.751|0.5373
72486202|NCT02871778|144500347|SUPERIORITY||LS Mean difference|0.838||||0.453|TWO_SIDED|95.0|-1.368|3.045|||Mixed-effects Model|||||3.045|-1.368|0.453
72486203|NCT02653300|144500356|OTHER|||||||0.03125|||||||Sign test|||||||0.03125
72486204|NCT02170779|144500359|SUPERIORITY_OR_OTHER|||||||0.84|||||||Wilcoxon (Mann-Whitney)|||||||0.84
72486205|NCT02170779|144500360|SUPERIORITY_OR_OTHER|||||||0.738|||||||Wilcoxon (Mann-Whitney)|||||||0.738
72486206|NCT02170779|144500361|SUPERIORITY_OR_OTHER|||||||0.8434|||||||Wilcoxon (Mann-Whitney)|||||||0.8434
72486207|NCT02170779|144500362|SUPERIORITY_OR_OTHER|||||||0.638|||||||Wilcoxon (Mann-Whitney)|||||||0.638
72486208|NCT02170779|144500363|SUPERIORITY_OR_OTHER|||||||0.492|||||||Wilcoxon (Mann-Whitney)|||||||0.492
72486209|NCT02170779|144500364|SUPERIORITY_OR_OTHER|||||||0.144|||||||Wilcoxon (Mann-Whitney)|||This analysis refers to the physical component of the MSIS-29||||0.144
72486210|NCT02170779|144500364|SUPERIORITY_OR_OTHER|||||||0.953|||||||Wilcoxon (Mann-Whitney)|||This refers to the psychological analysis for the MSIS-29.||||0.953
72486211|NCT02170779|144500365|SUPERIORITY_OR_OTHER|||||||0.915|||||||Wilcoxon (Mann-Whitney)|||||||0.915
72486212|NCT02170779|144500366|SUPERIORITY_OR_OTHER|||||||0.023|||||||Wilcoxon (Mann-Whitney)|||||||0.023
72486213|NCT02170779|144500367|SUPERIORITY_OR_OTHER|||||||0.11|||||||Wilcoxon (Mann-Whitney)|||||||0.11
72486214|NCT01286454|144500368|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|111.23|||||TWO_SIDED|90.0|102.69|120.47||||||Natural log transformed AUC (0 - ∞) of 5-HMT was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% confidence intervals (CIs) for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. Fesoterodine 4 mg ER Tablet Fasted was reference and Fesoterodine 4 mg IR-BIC Fasted was test.||120.47|102.69|
72486215|NCT01286454|144500368|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|103.07|||||TWO_SIDED|90.0|95.16|111.64||||||Natural log transformed AUC (0 - ∞) of 5-HMT was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. Fesoterodine 4 mg ER Tablet Fasted was reference and Fesoterodine 4 mg 10% ER-BIC Fasted was test.||111.64|95.16|
72486216|NCT01286454|144500368|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|70.36|||||TWO_SIDED|90.0|64.52|76.74||||||Natural log transformed AUC (0 - ∞) of 5-HMT was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. Fesoterodine 4 mg ER Tablet Fasted was reference and Fesoterodine 4 mg 15% ER-BIC Fasted was test.||76.74|64.52|
72486217|NCT01286454|144500368|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|113.55|||||TWO_SIDED|90.0|105.91|121.74||||||Natural log transformed AUC (0 - ∞) of 5-HMT was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. Fesoterodine 4 mg 10% ER-BIC Fasted was reference and Fesoterodine 4 mg 10% ER-BIC Fed was test.||121.74|105.91|
72486218|NCT01286454|144500369|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|112.8|||||TWO_SIDED|90.0|103.85|122.52||||||Natural log transformed AUClast of 5-HMT was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. Fesoterodine 4 mg ER Tablet Fasted was reference and Fesoterodine 4 mg IR-BIC Fasted was test.||122.52|103.85|
72486219|NCT01286454|144500369|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|103.71|||||TWO_SIDED|90.0|95.48|112.65||||||Natural log transformed AUClast of 5-HMT was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. Fesoterodine 4 mg ER Tablet Fasted was reference and Fesoterodine 4 mg 10% ER-BIC Fasted was test.||112.65|95.48|
72486220|NCT01286454|144500369|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|66.87|||||TWO_SIDED|90.0|61.56|72.63||||||Natural log transformed AUClast of 5-HMT was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. Fesoterodine 4 mg ER Tablet Fasted was reference and Fesoterodine 4 mg 15% ER-BIC Fasted was test.||72.63|61.56|
72513291|NCT04804033|144556702|OTHER||Difference in LSM|-9.0|||||TWO_SIDED|97.5|-18.1|0.19|||||Linear regression model had the following variables: Week 12 change from baseline in domain score as the dependent variable; baseline domain score as a covariate; treatment group and randomization stratum as fixed effects.|||0.19|-18.10|
72513292|NCT04804033|144556702|OTHER||Difference in LSM|-9.3|||||TWO_SIDED|97.5|-18.95|0.41|||||Linear regression model had the following variables: Week 12 change from baseline in domain score as the dependent variable; baseline domain score as a covariate; treatment group and randomization stratum as fixed effects.|||0.41|-18.95|
72486221|NCT01286454|144500369|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|28.34|||||TWO_SIDED|90.0|26.09|30.78||||||Natural log transformed AUClast of 5-HMT was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. Fesoterodine 4 mg ER Tablet Fasted was reference and Fesoterodine 4 mg 20% ER-BIC Fasted was test.||30.78|26.09|
72486222|NCT01286454|144500369|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|114.7|||||TWO_SIDED|90.0|106.99|122.97||||||Natural log transformed AUClast of 5-HMT was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. Fesoterodine 4 mg 10% ER-BIC Fasted was reference and Fesoterodine 4 mg 10% ER-BIC Fed was test.||122.97|106.99|
72486223|NCT01286454|144500370|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|259.4|||||TWO_SIDED|90.0|231.48|290.7||||||Natural log transformed Cmax of 5-HMT was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. Fesoterodine 4 mg ER Tablet Fasted was reference and Fesoterodine 4 mg IR-BIC Fasted was test.||290.70|231.48|
72486224|NCT01286454|144500370|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|134.83|||||TWO_SIDED|90.0|120.31|151.09||||||Natural log transformed Cmax of 5-HMT was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. Fesoterodine 4 mg ER Tablet Fasted was reference and Fesoterodine 4 mg 10% ER-BIC Fasted was test.||151.09|120.31|
72567760|NCT03623386|144667185|SUPERIORITY|||||||0.026||||||p value reflects the effect of time.|ANOVA|||Testing for main effects (group), time effect and the interaction of group and time.||||0.026
72567761|NCT04271735|144667208|SUPERIORITY|||||||0.01|||||||t-test, 2 sided|||||||0.01
72567762|NCT00515541|144667211|SUPERIORITY_OR_OTHER|||||||0.01||||||A P-value \<0.05 when compared to baseline is considered significant.|Wilcoxon (Mann-Whitney)|||Group B baseline vs. Group B Week 12||||0.01
72567763|NCT00515541|144667212|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||The median of Groups A, B, and C grouped together was compared Baseline to Week 6.||||<0.001
72567764|NCT00515541|144667212|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon (Mann-Whitney)|||The median of Groups A, B, and C grouped together was compared Baseline to Week 12.||||<0.001
72567765|NCT00922272|144667217|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||t-test, 2 sided|||||||<0.0001
72567766|NCT00922272|144667219|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.3||||0.4182|TWO_SIDED|95.0|-3.4|8.1|||ANCOVA|||||8.1|-3.4|0.4182
72402762|NCT01480076|144311692|SUPERIORITY_OR_OTHER|||||||0.0042|||||||mixed effect model|||Month 12, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0042
72486225|NCT01286454|144500370|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|48.58|||||TWO_SIDED|90.0|43.35|54.44||||||Natural log transformed Cmax of 5-HMT was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. Fesoterodine 4 mg ER Tablet Fasted was reference and Fesoterodine 4 mg 15% ER-BIC Fasted was test.||54.44|43.35|
72486226|NCT01286454|144500370|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|14.38|||||TWO_SIDED|90.0|12.83|16.11||||||Natural log transformed Cmax of 5-HMT was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. Fesoterodine 4 mg ER Tablet Fasted was reference and Fesoterodine 4 mg 20% ER-BIC Fasted was test.||16.11|12.83|
72486227|NCT01286454|144500370|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|171.06|||||TWO_SIDED|90.0|115.82|187.78||||||Natural log transformed Cmax of 5-HMT was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. Fesoterodine 4 mg 10% ER-BIC Fasted was reference and Fesoterodine 4 mg 10% ER-BIC Fed was test.||187.78|115.82|
72486228|NCT00369785|144500373|SUPERIORITY_OR_OTHER_LEGACY|||||||0.62||||||Not adjusted for multiple comparisons.|Mixed Models Analysis|||Null Hypothesis: No difference in immediate recall memory at 24 weeks||||.62
72486229|NCT00369785|144500374|SUPERIORITY_OR_OTHER_LEGACY|||||||0.007||||||Not adjusted for multiple comparisons.|Mixed Models Analysis|||Null Hypothesis: No difference in discrimination memory between the two groups||||.007
72486230|NCT00800683|144500375|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.15|<|0.0001||95.0|-0.89|-0.31|||ANCOVA|||For patients who received rescue medication during the course of the trial, the Oracle Clinical (OC) technique was utilised for all efficacy endpoints and the values were set to missing after the rescue medication was administered.||-0.31|-0.89|< 0.0001
72486231|NCT00800683|144500376|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.72|STANDARD_ERROR_OF_MEAN|0.16|<|0.0001||95.0|-1.03|-0.41|||ANCOVA|||||-0.41|-1.03|< 0.0001
72486232|NCT00800683|144500377|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.61|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001||95.0|-0.9|-0.33|||ANCOVA|||||-0.33|-0.90|< 0.0001
72486233|NCT00800683|144500378|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.68|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001||95.0|-0.96|-0.41|||ANCOVA|||||-0.41|-0.96|< 0.0001
72486234|NCT00800683|144500379|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.72|STANDARD_ERROR_OF_MEAN|0.17|<|0.0001||95.0|-1.05|-0.39|||ANCOVA|||||-0.39|-1.05|< 0.0001
72486235|NCT00800683|144500380|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.75|STANDARD_ERROR_OF_MEAN|0.16|<|0.0001||95.0|-1.06|-0.44|||ANCOVA|||||-0.44|-1.06|< 0.0001
72486236|NCT00800683|144500381|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.64|STANDARD_ERROR_OF_MEAN|0.16|<|0.0001||95.0|-0.96|-0.33|||ANCOVA|||||-0.33|-0.96|< 0.0001
72486237|NCT00800683|144500382|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.73|STANDARD_ERROR_OF_MEAN|0.15|<|0.0001||95.0|-1.02|-0.44|||ANCOVA|||||-0.44|-1.02|< 0.0001
72486238|NCT00800683|144500383|SUPERIORITY_OR_OTHER|||||||0.1199||95.0||||P-value calculated using a Fisher's exact Test.|Fisher Exact|||||||0.1199
72486239|NCT00800683|144500384|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.103||||0.2225||95.0|0.003|3.978|||Regression, Logistic|||Linagliptin vs Placebo. The odds-ratio is based on a logistic regression model including baseline HbA1c, previous anti-diabetic medication and creatinine clearance||3.978|0.003|0.2225
72567767|NCT00922272|144667220|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6705||95.0|||||Fisher Exact|||||||0.6705
72567768|NCT00922272|144667221|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||t-test, 2 sided|||Affective Flattening||||<0.0001
72567769|NCT00922272|144667221|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||t-test, 2 sided|||Alogia||||<0.0001
72567770|NCT00922272|144667221|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||t-test, 2 sided|||Avolition-Apathy||||<0.0001
72567771|NCT00922272|144667221|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||t-test, 2 sided|||Anhedonia-Asociality||||<0.0001
72567772|NCT00922272|144667221|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||t-test, 2 sided|||Attention||||<0.0001
72567773|NCT00922272|144667222|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0||||0.8771|TWO_SIDED|95.0|-0.4|0.5|||ANCOVA|||Affective Flattening||0.5|-0.4|0.8771
72567774|NCT00922272|144667222|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.6||||0.0584|TWO_SIDED|95.0|0.0|1.1|||ANCOVA|||Alogia||1.1|0.0|0.0584
72567775|NCT00922272|144667222|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.1||||0.5215|TWO_SIDED|95.0|-0.3|0.6|||ANCOVA|||Avolition-Apathy||0.6|-0.3|0.5215
72567776|NCT00922272|144667222|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.2||||0.4835|TWO_SIDED|95.0|-0.3|0.7|||ANCOVA|||Anhedonia-Asociality||0.7|-0.3|0.4835
72486240|NCT00800683|144500385|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.816||||0.8927|TWO_SIDED|95.0|0.042|15.756|||Regression, Logistic|||Linagliptin vs Placebo. The odds-ratio is based on a logistic regression model including baseline HbA1c, previous anti-diabetic medication and creatinine clearance||15.756|0.042|0.8927
72486241|NCT00800683|144500386|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.73|STANDARD_ERROR_OF_MEAN|11.43||0.8802||95.0|-24.36|20.91|||ANCOVA|||||20.91|-24.36|0.8802
72486242|NCT00800683|144500387|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.24|STANDARD_ERROR_OF_MEAN|8.19||0.7848||95.0|-18.47|13.98|||ANCOVA|||||13.98|-18.47|0.7848
72486243|NCT00800683|144500388|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.72|STANDARD_ERROR_OF_MEAN|8.09||0.1878||95.0|-26.74|5.31|||ANCOVA|||||5.31|-26.74|0.1878
72486244|NCT00800683|144500389|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.42|STANDARD_ERROR_OF_MEAN|7.92||0.5781||95.0|-11.28|20.12|||ANCOVA|||||20.12|-11.28|0.5781
72486245|NCT00800683|144500390|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.24|STANDARD_ERROR_OF_MEAN|8.8||0.2954||95.0|-26.67|8.18|||ANCOVA|||||8.18|-26.67|0.2954
72486246|NCT00800683|144500391|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.37|STANDARD_ERROR_OF_MEAN|8.27||0.5984||95.0|-12.02|20.75|||ANCOVA|||||20.75|-12.02|0.5984
72486247|NCT00800683|144500392|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.07|STANDARD_ERROR_OF_MEAN|8.53||0.4085||95.0|-9.82|23.96|||ANCOVA|||||23.96|-9.82|0.4085
72486248|NCT00800683|144500393|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.34|STANDARD_ERROR_OF_MEAN|8.17||0.8698||95.0|-14.84|17.52|||ANCOVA|||||17.52|-14.84|0.8698
72486249|NCT02367066|144500396|SUPERIORITY_OR_OTHER||Geometric LS Mean Ratio|0.94|STANDARD_ERROR_OF_MEAN|0.02||0.02|TWO_SIDED|80.0|0.9|0.98||1-sided|Mixed Models Analysis|||||0.98|0.90|0.02
72486250|NCT02367066|144500397|SUPERIORITY_OR_OTHER||Geometric LS Mean Ratio|0.96|STANDARD_ERROR_OF_MEAN|0.03||0.06|TWO_SIDED|80.0|0.92|0.99||1-sided|Mixed Models Analysis|||||0.99|0.92|0.06
72486251|NCT02367066|144500398|SUPERIORITY_OR_OTHER||Geometric LS Mean Ratio|0.99|STANDARD_ERROR_OF_MEAN|0.03||0.41|TWO_SIDED|80.0|0.96|1.03||1-sided|Mixed Models Analysis|||||1.03|0.96|0.41
72486252|NCT02367066|144500399|SUPERIORITY_OR_OTHER||Geometric LS Mean Ratio|0.92|STANDARD_ERROR_OF_MEAN|0.05||0.06|TWO_SIDED|80.0|0.85|0.99||1-sided|Mixed Models Analysis|||||0.99|0.85|0.06
72486253|NCT02367066|144500400|SUPERIORITY_OR_OTHER||Geometric LS Mean Ratio|1.06|STANDARD_ERROR_OF_MEAN|0.04||0.18|TWO_SIDED|80.0|0.99|1.13||1-sided|Mixed Models Analysis|||||1.13|0.99|0.18
72486254|NCT02367066|144500401|SUPERIORITY_OR_OTHER||Geometric LS Mean Ratio|0.93|STANDARD_ERROR_OF_MEAN|0.04||0.04|TWO_SIDED|80.0|0.89|0.98||1-sided|Mixed Models Analysis|||||0.98|0.89|0.04
72486255|NCT02367066|144500403|SUPERIORITY_OR_OTHER||Geometric LS MEan Ratio|1.0|STANDARD_ERROR_OF_MEAN|0.05||0.37|TWO_SIDED|80.0|0.91|1.06||1-sided|Mixed Models Analysis|||||1.06|0.91|0.37
72486256|NCT02367066|144500405|SUPERIORITY_OR_OTHER||Geometric LS Mean Ratio|1.02|STANDARD_ERROR_OF_MEAN|0.01||0.06|TWO_SIDED|80.0|1.0|1.04||1-sided|Mixed Models Analysis|||||1.04|1.00|0.06
72486257|NCT02367066|144500406|SUPERIORITY_OR_OTHER||LS Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.01||0.45|TWO_SIDED|90.0|-0.01|0.03||2-sided|Mixed Models Analysis|||||0.03|-0.01|0.45
72486258|NCT01898689|144500423|EQUIVALENCE|The a priori equivalence region for the difference in means between the two concentrations was specified as +10 mA. This value was considered the minimal clinically relevant current since it approximates the tolerated electrical current range at baseline of the general population-in other words, natural variability and therefore a relatively small amount of current to detect.|Mean Difference (Net)|0.2||||0.02|TWO_SIDED|90.0|-8.2|8.5||"P-values from the TOST procedure were 0.02 and 0.03 for the mean being inside the lower and upper boundaries, respectively.~(estimated mean difference of 0.2 mA; 90% CI 28.2 to 8.5)"|Mixed Models Analysis|||"The null and alternative hypotheses were thus:~H0: m0.1%-m0.4% ≤ -10 or m0.1%-m0.4% ≥ 10 and Ha: -10 , m0.1%-m0.4% , 10 where m0.1% and m0.1% are the population means for tolerance to current under 0.1% and 0.4% ropivacaine, respectively.~With 24 evaluable subjects, we had 90% power at the 0.05 significance level to detect equivalence of 0.1% and 0.4% ropivacaine concentration on the mean tolerance to transcutaneous electrical stimulation"||8.5|-8.2|0.02
72486259|NCT04556136|144500426|NON_INFERIORITY|This non-inferiority study was designed to demonstrate the ability of the phototherapy kiosk to safely administer UVB radiation to participants with varying levels of 25(OH)D and achieve comparable levels of serum 25(OH)D in a similar population of adults randomized to receive RDA of 600 IU vitamin D oral supplementation daily. It is important to evaluate device equivalence to standard of care in the maintenance of sufficient levels of vitamin D in adults 18 - 70 years old.||||||0.01||||||Threshold for significance \<0.05|Wilcoxon (Mann-Whitney)|Effect sizes for significant differences were included as eta squared (ŋ2) values.||The intent-to-treat analysis plan was carried out with all available subject data points. No interim analysis was performed. Exploratory data analyses were conducted on serum vitamin D levels of participants assigned to either the oral supplementation or kiosk group. Analysis was restricted to participants with valid baseline serum vitamin D data and at least one follow-up blood draw. The Shapiro-Wilk test was used to assess the normality of the data distribution.||||0.01
72486260|NCT01196533|144500442|SUPERIORITY_OR_OTHER||||||||||||||||||All data in the outcome measure table is presenting the percentage of error.|||
72486261|NCT00529451|144500448|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin of 2.25 mm Hg|Mean Difference (Final Values)|-2.44|||||TWO_SIDED|95.0|-3.63|-1.25||||||||-1.25|-3.63|
72486262|NCT00529451|144500449|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin of 2.25 mm Hg|Mean Difference (Final Values)|-0.86|||||TWO_SIDED|95.0|-2.06|0.34||||||||0.34|-2.06|
72486263|NCT00529451|144500450|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin of 2.25 mm Hg|Mean Difference (Final Values)|-1.48|||||TWO_SIDED|95.0|-2.67|-0.28||||||||-0.28|-2.67|
72486264|NCT04666350|144500453|OTHER||Combined Difference in Prevalence|-0.025||||0.711|TWO_SIDED|95.0|-0.16|0.109|||Other|The p-value is estimated assuming the combined difference over the square root of the weighted variance follows a normal distribution.||Comparison of DSFA Day 2 versus Day 1. For each participant, the difference in oocyte prevalence using DSFA on Day 1 versus Day 2 was estimated. To evaluate the hypothesis that the average mean difference in the prevalence between two assays within the same subject is zero, combined estimates (weighted mean and variance) were obtained using as weight the inverse of the variance of each paired difference obtained from the Agresti and Caffo method.||0.109|-0.160|0.711
72567777|NCT00922272|144667222|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.1||||0.5723|TWO_SIDED|95.0|-0.4|0.7|||ANCOVA|||Attention||0.7|-0.4|0.5723
72513293|NCT00543569|144556718|NON_INFERIORITY_OR_EQUIVALENCE|The aim of this study was to assess the non-inferiority of each experimental arm (Arms 2-4) to a comparator regimen (Arm 1) over a non-inferiority margin of 10%. If the upper bound of the 90% confidence interval was less than the margin, i.e., 10%, then the test treatment was considered to be non-inferior to the comparator regimen.|Difference|13.6|||||TWO_SIDED|90.0|3.2|23.9|||||A positive difference indicates a higher failure rate in the experimental arm as compared to the comparator arm (Arm 1).|||23.9|3.2|
72513294|NCT00543569|144556718|NON_INFERIORITY_OR_EQUIVALENCE|The aim of this study was to assess the non-inferiority of each experimental arm (Arms 2-4) to a comparator regimen (Arm 1) over a non-inferiority margin of 10%. If the upper bound of the 90% confidence interval was less than the margin, i.e., 10%, then the test treatment was considered to be non-inferior to the comparator regimen.|Difference|6.1|||||TWO_SIDED|90.0|-3.6|15.8|||||A positive difference indicates a higher failure rate in the experimental arm as compared to the comparator arm (Arm 1).|||15.8|-3.6|
72513295|NCT00543569|144556718|NON_INFERIORITY_OR_EQUIVALENCE|The aim of this study was to assess the non-inferiority of each experimental arm (Arms 2-4) to a comparator regimen (Arm 1) over a non-inferiority margin of 10%. If the upper bound of the 90% confidence interval was less than the margin, i.e., 10%, then the test treatment was considered to be non-inferior to the comparator regimen.|Difference|4.0|||||TWO_SIDED|90.0|-5.3|13.3|||||A positive difference indicated a higher failure rate in the experimental arm as compared to the comparator arm (Arm 1).|||13.3|-5.3|
72513296|NCT00543569|144556719|SUPERIORITY_OR_OTHER||Difference|-1.4|||||TWO_SIDED|90.0|-6.9|4.1||||||Patient survival at 6 months||4.1|-6.9|
72513297|NCT00543569|144556719|SUPERIORITY_OR_OTHER||Difference|1.1|||||TWO_SIDED|90.0|-3.5|5.8||||||Patient survival at 6 months||5.8|-3.5|
72513298|NCT00543569|144556719|SUPERIORITY_OR_OTHER||Difference|-2.6|||||TWO_SIDED|90.0|-8.4|3.2||||||Patient survival at 6 months||3.2|-8.4|
72513299|NCT00543569|144556719|SUPERIORITY_OR_OTHER||Difference|4.9|||||TWO_SIDED|90.0|-3.1|12.8||||||Patient survival at 12 months||12.8|-3.1|
72513300|NCT00543569|144556719|SUPERIORITY_OR_OTHER||Difference|0.5|||||TWO_SIDED|90.0|-8.3|9.2||||||Patient survival at 12 months||9.2|-8.3|
72513301|NCT00543569|144556719|SUPERIORITY_OR_OTHER||Difference|2.4|||||TWO_SIDED|90.0|-6.0|10.8||||||Patient survival at 12 months||10.8|-6.0|
72513302|NCT00543569|144556720|SUPERIORITY_OR_OTHER||Difference|-2.7|||||TWO_SIDED|90.0|-8.5|3.1||||||Graft survival at 6 months||3.1|-8.5|
72513303|NCT00543569|144556720|SUPERIORITY_OR_OTHER||Difference|-0.2|||||TWO_SIDED|90.0|-5.3|4.9||||||Graft survival at 6 months||4.9|-5.3|
72513304|NCT00543569|144556720|SUPERIORITY_OR_OTHER||Difference|-3.9|||||TWO_SIDED|90.0|-10.0|2.2||||||Graft survival at 6 months||2.2|-10.0|
72513305|NCT00543569|144556720|SUPERIORITY_OR_OTHER||Difference|3.6|||||TWO_SIDED|90.0|-4.6|11.7||||||Graft survival at 12 months||11.7|-4.6|
72513306|NCT00543569|144556720|SUPERIORITY_OR_OTHER||Difference|-0.9|||||TWO_SIDED|90.0|-9.9|8.1||||||Graft survival at 12 months||8.1|-9.9|
72513307|NCT00543569|144556720|SUPERIORITY_OR_OTHER||Difference|-1.6|||||TWO_SIDED|90.0|-10.6|7.4||||||Graft survival at 12 months||7.4|-10.6|
72513308|NCT00543569|144556721|SUPERIORITY_OR_OTHER||Difference|13.7|||||TWO_SIDED|90.0|2.8|24.6||||||||24.6|2.8|
72513309|NCT00543569|144556721|SUPERIORITY_OR_OTHER||Difference|4.8|||||TWO_SIDED|90.0|-5.4|15.0||||||||15.0|-5.4|
72513310|NCT00543569|144556721|SUPERIORITY_OR_OTHER||Difference|2.8|||||TWO_SIDED|90.0|-7.1|12.6||||||||12.6|-7.1|
72513311|NCT00543569|144556722|SUPERIORITY_OR_OTHER||Difference|10.6|||||TWO_SIDED|90.0|1.8|19.5||||||BCAR at Month 6||19.5|1.8|
72513312|NCT00543569|144556722|SUPERIORITY_OR_OTHER||Difference|4.3|||||TWO_SIDED|90.0|-3.6|12.3||||||BCAR at Month 6||12.3|-3.6|
72513313|NCT00543569|144556722|SUPERIORITY_OR_OTHER||Difference|6.4|||||TWO_SIDED|90.0|-1.7|14.6||||||BCAR at Month 6||14.6|-1.7|
72513314|NCT00543569|144556722|SUPERIORITY_OR_OTHER||Difference|12.0|||||TWO_SIDED|90.0|3.0|21.0||||||BCAR at Month 12||21.0|3.0|
72513315|NCT00543569|144556722|SUPERIORITY_OR_OTHER||Difference|4.3|||||TWO_SIDED|90.0|-3.6|12.3||||||BCAR at Month 12||12.3|-3.6|
72513316|NCT00543569|144556722|SUPERIORITY_OR_OTHER||Difference|7.8|||||TWO_SIDED|90.0|-0.6|16.2||||||BCAR at Month 12||16.2|-0.6|
72513317|NCT00543569|144556723|SUPERIORITY_OR_OTHER||Difference|12.2|||||TWO_SIDED|90.0|2.0|22.5||||||T-cell Mediated BCAR at Month 6||22.5|2.0|
72513318|NCT00543569|144556723|SUPERIORITY_OR_OTHER||Difference|6.1|||||TWO_SIDED|90.0|-3.6|15.8||||||T-cell Mediated BCAR at Month 6||15.8|-3.6|
72513319|NCT00543569|144556723|SUPERIORITY_OR_OTHER||Difference|4.0|||||TWO_SIDED|90.0|-5.3|13.3||||||T-cell Mediated BCAR at Month 6||13.3|-5.3|
72513320|NCT00543569|144556723|SUPERIORITY_OR_OTHER||Difference|13.6|||||TWO_SIDED|90.0|3.0|24.3||||||T-cell Mediated BCAR at Month 12||24.3|3.0|
72513321|NCT00543569|144556723|SUPERIORITY_OR_OTHER||Difference|4.8|||||TWO_SIDED|90.0|-5.1|14.6||||||T-cell Mediated BCAR at Month 12||14.6|-5.1|
72513322|NCT00543569|144556723|SUPERIORITY_OR_OTHER||Difference|4.1|||||TWO_SIDED|90.0|-5.6|13.8||||||T-cell Mediated BCAR at Month 12||13.8|-5.6|
72513323|NCT00543569|144556724|SUPERIORITY_OR_OTHER||Difference|9.3|||||TWO_SIDED|90.0|0.7|18.0||||||T-cell Mediated BCAR at Month 6||18.0|0.7|
72513324|NCT00543569|144556724|SUPERIORITY_OR_OTHER||Difference|4.3|||||TWO_SIDED|90.0|-3.6|12.3||||||T-cell Mediated BCAR at Month 6||12.3|-3.6|
72513325|NCT00543569|144556724|SUPERIORITY_OR_OTHER||Difference|6.4|||||TWO_SIDED|90.0|-1.7|14.6||||||T-cell Mediated BCAR at Month 6||14.6|-1.7|
72513326|NCT00543569|144556724|SUPERIORITY_OR_OTHER||Difference|10.7|||||TWO_SIDED|90.0|1.8|19.5||||||T-cell Mediated BCAR at Month 12||19.5|1.8|
72513327|NCT00543569|144556724|SUPERIORITY_OR_OTHER||Difference|4.3|||||TWO_SIDED|90.0|-3.6|12.3||||||T-cell Mediated BCAR at Month 12||12.3|-3.6|
72513328|NCT00543569|144556724|SUPERIORITY_OR_OTHER||Difference|7.8|||||TWO_SIDED|90.0|-0.6|16.2||||||T-cell Mediated BCAR at Month 12||16.2|-0.6|
72513329|NCT00543569|144556728|SUPERIORITY_OR_OTHER||Difference|14.7|||||TWO_SIDED|90.0|3.8|25.5||||||Efficacy Failure at Month 6||25.5|3.8|
72513330|NCT00543569|144556728|SUPERIORITY_OR_OTHER||Difference|7.5|||||TWO_SIDED|90.0|-2.9|17.8||||||Efficacy Failure at Month 6||17.8|-2.9|
72513331|NCT00543569|144556728|SUPERIORITY_OR_OTHER||Difference|7.9|||||TWO_SIDED|90.0|-2.4|18.2||||||Efficacy Failure at Month 6||18.2|-2.4|
72513332|NCT00543569|144556728|SUPERIORITY_OR_OTHER||Difference|8.4|||||TWO_SIDED|90.0|-3.5|20.4||||||Efficacy Failure at Month12||20.4|-3.5|
72513333|NCT00543569|144556728|SUPERIORITY_OR_OTHER||Difference|4.0|||||TWO_SIDED|90.0|-7.8|15.8||||||Efficacy Failure at Month 12||15.8|-7.8|
72513334|NCT00543569|144556728|SUPERIORITY_OR_OTHER||Difference|4.2|||||TWO_SIDED|90.0|-7.5|15.9||||||Efficacy Failure at Month12||15.9|-7.5|
72486265|NCT04666350|144500453|OTHER||Combined Difference in Prevalence|-0.016||||0.795|TWO_SIDED|95.0|-0.139|0.107|||Other|The p-value is estimated assuming the combined difference over the square root of the weighted variance follows a normal distribution.||Comparison of DMFA Day 2 versus Day 1. For each participant, the difference in oocyte prevalence using DMFA on Day 1 versus Day 2 was estimated. To evaluate the hypothesis that the average mean difference in the prevalence between two assays within the same subject is zero, combined estimates (weighted mean and variance) were obtained using as weight the inverse of the variance of each paired difference obtained from the Agresti and Caffo method.||0.107|-0.139|0.795
72486266|NCT04666350|144500454|OTHER||Relative Rate|0.38||||0.019|TWO_SIDED|95.0|0.21|0.7||Difference between days was evaluated using zero inflated Poisson regression models having as outcome the number of oocysts, as offset the number of surviving mosquitoes, and adjusted by subject.|Poisson Regression|||Comparison of DSFA Day 2 versus Day 1.||0.70|0.21|0.019
72486267|NCT04666350|144500454|OTHER||Relative Rate|0.23||||0.003|TWO_SIDED|95.0|0.11|0.45||Difference between days was evaluated using zero inflated Poisson regression models having as outcome the number of oocysts, as offset the number of surviving mosquitoes, and adjusted by subject.|Poisson Regression|||Comparison of DMFA Day 2 versus Day 1.||0.45|0.11|0.003
72486268|NCT04666350|144500455|OTHER||Combined Difference in Prevalence|-0.023||||0.75|TWO_SIDED|95.0|-0.164|0.118|||Other|The p-value is estimated assuming the combined difference over the square root of the weighted variance follows a normal distribution.||Comparison of DSFA Day 2 versus Day 1. For each participant, the difference in sporozoite prevalence using DSFA on Day 1 versus Day 2 was estimated. To evaluate the hypothesis that the average mean difference in the prevalence between two assays within the same subject is zero, combined estimates (weighted mean and variance) were obtained using as weight the inverse of the variance of each paired difference obtained from the Agresti and Caffo method.||0.118|-0.164|0.750
72486269|NCT04666350|144500455|OTHER||Combined Difference in Prevalence|-0.031||||0.681|TWO_SIDED|95.0|-0.178|0.117|||Other|The p-value is estimated assuming the combined difference over the square root of the weighted variance follows a normal distribution.||Comparison of DMFA Day 2 versus Day 1. For each participant, the difference in sporozoite prevalence using DMFA on Day 1 versus Day 2 was estimated. To evaluate the hypothesis that the average mean difference in the prevalence between two assays within the same subject is zero, combined estimates (weighted mean and variance) were obtained using as weight the inverse of the variance of each paired difference obtained from the Agresti and Caffo method.||0.117|-0.178|0.681
72513335|NCT00543569|144556729|SUPERIORITY_OR_OTHER||Difference|10.7|||||TWO_SIDED|90.0|0.9|20.4||||||Efficacy Failure at Month 6||20.4|0.9|
72513336|NCT00543569|144556729|SUPERIORITY_OR_OTHER||Difference|4.6|||||TWO_SIDED|90.0|-4.5|13.7||||||Efficacy Failure at Month 6||13.7|-4.5|
72513337|NCT00543569|144556729|SUPERIORITY_OR_OTHER||Difference|9.1|||||TWO_SIDED|90.0|-0.4|18.7||||||Efficacy Failure at Month 6||18.7|-0.4|
72513338|NCT00543569|144556729|SUPERIORITY_OR_OTHER||Difference|7.0|||||TWO_SIDED|90.0|-4.0|18.0||||||Efficacy Failure at Month 12||18.0|-4.0|
72513339|NCT00543569|144556729|SUPERIORITY_OR_OTHER||Difference|2.3|||||TWO_SIDED|90.0|-8.3|13.0||||||Efficacy Failure at Month 12||13.0|-8.3|
72513340|NCT00543569|144556729|SUPERIORITY_OR_OTHER||Difference|6.7|||||TWO_SIDED|90.0|-4.2|17.6||||||Efficacy Failure at Month 12||17.6|-4.2|
72402763|NCT01480076|144311692|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 12, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
72402764|NCT01480076|144311692|SUPERIORITY_OR_OTHER|||||||0.7329|||||||mixed effect model|||Month 12, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.7329
72402765|NCT01480076|144311692|SUPERIORITY_OR_OTHER||difference of LS means|13.2|STANDARD_ERROR_OF_MEAN|2.65|<|0.0001|TWO_SIDED||||||mixed effect model|||Month 12, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
72402766|NCT01480076|144311692|SUPERIORITY_OR_OTHER||difference of LS means|10.1|STANDARD_ERROR_OF_MEAN|4.49||0.0242|TWO_SIDED||||||mixed effect model|||Month 12, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0242
72486270|NCT00097773|144500468|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.95||||0.86|TWO_SIDED|95.0|0.54|1.66||There was no significant interaction with ciprofloxacin in this analysis.|Regression, Cox||risk of exacerbation comparing cycled therapy to culture-based therapy|The primary analysis compared the pooled Cycled Therapy group (n=152) vs. the Pooled culture-based therapy group (n=152). The null hypothesis was no difference between groups in the risk of pulmonary exacerbation requiring IV antibiotics or hospitalization. Assuming a total sample size of 300 (150 per group), the study provided 80% power to detect at least a 40% reduction in the risk of exacerbation in the cycled group as compared to the culture-based group at the two-sided alpha level of 5%.||1.66|0.54|0.86
72486271|NCT00097773|144500468|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.45||||0.2|TWO_SIDED|95.0|0.82|2.54|||Regression, Cox||risk of exacerbation comparing oral cipro to oral placebo|A secondary comparison was between the pooled oral cipro (n=152)and pooled placebo groups (n=152. Null hypothesis was no difference between groups.||2.54|0.82|0.20
72486272|NCT00097773|144500469|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.78||||0.28||95.0|0.49|1.23|||Regression, Logistic|No interaction with ciprofloxacin usage was observed.|odds of a positive culture comparing cycled therapy to culture-based therapy|Null hypothesis is that there is no difference between pooled cycled and culture-based treatment groups in the odds of a Pa positive culture over the 18 month study.||1.23|0.49|0.28
72402767|NCT01480076|144311693|SUPERIORITY_OR_OTHER|||||||0.0001|||||||mixed effect model|||Overall, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D index scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0001
72402768|NCT01480076|144311693|SUPERIORITY_OR_OTHER|||||||0.9151|||||||mixed effect model|||Overall, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D index scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.9151
72402769|NCT01480076|144311693|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Overall, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D index scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
72486273|NCT00097773|144500469|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.1||||0.67|TWO_SIDED|95.0|0.71|1.71|||Regression, Logistic||odds of a positive culture comparing the cipro group to the placebo group|Null hypothesis is that there is no difference between pooled cipro and placebo treatment groups in the odds of a Pa positive culture over the 18 month study.||1.71|0.71|0.67
72486274|NCT00097773|144500470|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.8||||0.18|TWO_SIDED|95.0|0.58|1.11|||Regression, Cox|No interaction with ciprofloxacin usage was observed.|Hazard ratio comparing cycled to culture based therapy|The analysis compared the pooled Cycled Therapy group (n=152) vs. the Pooled culture-based therapy group (n=152). The null hypothesis was no difference between groups in the risk of pulmonary exacerbation.||1.11|0.58|0.18
72513341|NCT00543569|144556739|SUPERIORITY_OR_OTHER||Difference|11.1|||||TWO_SIDED|90.0|-1.1|23.3||||||Treatment Failure at Month 6||23.3|-1.1|
72513342|NCT00543569|144556739|SUPERIORITY_OR_OTHER||Difference|11.8|||||TWO_SIDED|90.0|-0.7|24.2||||||Treatment Failure at Month 6||24.2|-0.7|
72513343|NCT00543569|144556739|SUPERIORITY_OR_OTHER||Difference|2.9|||||TWO_SIDED|90.0|-8.9|14.7||||||Treatment Failure at Month 6||14.7|-8.9|
72513344|NCT00543569|144556739|SUPERIORITY_OR_OTHER||Difference|10.0|||||TWO_SIDED|90.0|-2.9|22.8||||||Treatment Failure at Month 12||22.8|-2.9|
72513345|NCT00543569|144556739|SUPERIORITY_OR_OTHER||Difference|9.7|||||TWO_SIDED|90.0|-3.3|22.8||||||Treatment Failure at Month 12||22.8|-3.3|
72513346|NCT00543569|144556739|SUPERIORITY_OR_OTHER||Difference|-0.8|||||TWO_SIDED|90.0|-13.3|11.7||||||Treatment Failure at Month 12||11.7|-13.3|
72567778|NCT00922272|144667223|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||t-test, 2 sided|||Positive subscale||||<0.0001
72567779|NCT00922272|144667223|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||t-test, 2 sided|||Negative subscale||||<0.0001
72567780|NCT00922272|144667223|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||t-test, 2 sided|||General Psychopathology subscale||||<0.0001
72486275|NCT00097773|144500470|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.29||||0.12|TWO_SIDED|95.0|0.94|1.78|||Regression, Cox||Hazard ratio comparing cipro to placebo.|This analysis was between the pooled oral cipro (n=152)and pooled placebo groups (n=152. Null hypothesis was no difference between groups.||1.78|0.94|0.12
72486276|NCT00617604|144500487|SUPERIORITY_OR_OTHER||Difference|3.9|||||TWO_SIDED|90.0|-2.5|10.3||||||||10.3|-2.5|
72486277|NCT00617604|144500488|SUPERIORITY_OR_OTHER||Difference|1.0|||||TWO_SIDED|90.0|-3.1|5.0||||||||5.0|-3.1|
72486278|NCT00617604|144500489|SUPERIORITY_OR_OTHER||Difference|3.0|||||TWO_SIDED|90.0|-4.0|10.1||||||||10.1|-4.0|
72486279|NCT00617604|144500490|SUPERIORITY_OR_OTHER||Difference|1.0|||||TWO_SIDED|90.0|-0.6|2.5||||||||2.5|-0.6|
72486280|NCT00617604|144500491|SUPERIORITY_OR_OTHER||Difference|-5.1|||||TWO_SIDED|90.0|-14.9|4.7||||||||4.7|-14.9|
72486281|NCT00617604|144500492|SUPERIORITY_OR_OTHER||Difference|-9.4|||||TWO_SIDED|90.0|-18.5|0.0||||||||0.0|-18.5|
72486282|NCT00617604|144500493|SUPERIORITY_OR_OTHER||Difference|-1.9|||||TWO_SIDED|90.0|-7.6|3.8||||||||3.8|-7.6|
72486283|NCT00617604|144500494|SUPERIORITY_OR_OTHER||Difference|-1.8|||||TWO_SIDED|90.0|-8.2|4.6||||||||4.6|-8.2|
72486284|NCT00617604|144500495|SUPERIORITY_OR_OTHER||Difference|1.9|||||TWO_SIDED|90.0|-1.3|5.0||||||||5.0|-1.3|
72486285|NCT00617604|144500496|SUPERIORITY_OR_OTHER||Difference|4.6|||||TWO_SIDED|90.0|-1.2|10.4||||||||10.4|-1.2|
72513347|NCT00305253|144556801|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.38||||0.019|TWO_SIDED|95.0|0.17|0.85|||Regression, Logistic|Independent variables were selected on the basis of their significant association with EAO in bivariate analyses (t-tests and logistic regression).|Pre-Intervention group was compared to the Post-Intervention group. Each group contained different study participants.|"Relative risks and confidence intervals were computed for the primary outcome, Extreme Adverse Outcomes (EAO) - a combined measure of maternal mortality or severe mobidity.~To estimate the independent effect of the intervention net of the effects of other baseline characteristics, a multiple logistic regression model was used."||0.85|0.17|0.019
72486286|NCT00617604|144500498|SUPERIORITY_OR_OTHER||Difference|2.0|||||TWO_SIDED|90.0|-3.3|7.2||||||||7.2|-3.3|
72513348|NCT00305253|144556802|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.79|||<|0.0001|TWO_SIDED|95.0|||||t-test, 2 sided||Pre-Intervention group was compared to the Post-Intervention group. Each group contained different study participants.|Mean measured volume of blood loss in the drape was compared across phases with t-tests.||||<0.0001
72486287|NCT00617604|144500503|SUPERIORITY_OR_OTHER||Slope|6.0|||||TWO_SIDED|90.0|-2.7|14.6||||||||14.6|-2.7|
72486288|NCT00617604|144500504|SUPERIORITY_OR_OTHER||Difference|-4.5|||||TWO_SIDED|90.0|-11.2|2.2||||||||2.2|-11.2|
72486289|NCT00617604|144500505|SUPERIORITY_OR_OTHER||Difference|5.2|||||TWO_SIDED|90.0|-4.4|14.7||||||||14.7|-4.4|
72486290|NCT02303704|144500546|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|to check the equality of means|||||<|0.05|TWO_SIDED|||||P-value less than 0.05 was considered significant|t-test, 2 sided|two compare two independent quantitative groups||Null hypothesis was there is no significant difference between the means of two groups||||<0.05
72486291|NCT02303704|144500547|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|to check the equality of means between the two groups|||||<|0.05|TWO_SIDED||||||t-test, 2 sided|||||||<0.05
72486292|NCT02303704|144500548|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|to check the equality of means|||||<|0.05|TWO_SIDED|||||p-value \<0.05 was considered significant.|t-test, 2 sided|To compare the means between the two groups, to find out the significant difference between Group I and II.||Null Hypothesis: The dose of nor-adrenaline on weaning from CPB is same for Group I and II.||||<0.05
72486293|NCT02303704|144500549|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|to chek the equality of means between the two groups|||||<|0.05|TWO_SIDED||||||t-test, 2 sided|||||||<0.05
72486294|NCT02303704|144500550|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05|TWO_SIDED|||||p- value less than 0.05 was considered as significant difference in proportion between the two groups|Chi-squared|two compare the qualitative data between two groups||Null Hypothesis:The proportion of IABP use is same between the two groups||||<0.05
72513349|NCT00305253|144556803|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.41|||<|0.05|TWO_SIDED|95.0|0.21|0.8|||t-test, 2 sided||Pre-Intervention group was compared to the Post-Intervention group. Each group contained different study participants.|Relative risks and confidence intervals were computed for emergency hysterectomy.||0.80|0.21|<0.05
72486295|NCT02303704|144500551|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05|TWO_SIDED|||||P-value \<0.05 was considered to be significant i.e. operative mortality is not same between the two groups|Fisher Exact|Fisher exact test was used because 1 cell (25%) have expected count less than 5.||Null Hypothesis: Operative mortality ratio is same in both groups||||<0.05
72486296|NCT01984164|144500561|SUPERIORITY||Treatment effect size|-13.6|||||TWO_SIDED|95.0|-23.6|-3.7|||||effect size p-value = 0.008|All analyses were conducted using the intention-to-treat principle. Results are provided as adjusted least-square means with SE and effect size (ES) estimates (calculated from mixed model with repeated measures (MMRM) as the adjusted difference in cognitive change between the 2 groups over the study period).||-3.7|-23.6|
72486297|NCT05293743|144500576|EQUIVALENCE|This analysis uses Welch's t-tests to calculate statistical significance, given the different variances and sample sizes of the populations.||||||0.67||||||The threshold for statistical significance was p = 0.05.|t-test, 2 sided|Degrees of Freedom = 3.82.||The null hypothesis is that there is no difference in brace adherence fractions between the control arm and the experimental arm during the study's intervention period. In this test, brace wear was measured by parent-reported brace logs.||||0.67
72486298|NCT05293743|144500576|EQUIVALENCE|This analysis uses Welch's t-tests to calculate statistical significance, given the different variances and sample sizes of the populations.||||||0.23||||||The threshold for statistical significance was p = 0.05.|t-test, 2 sided|Degrees of Freedom = 3.70.||The null hypothesis is that there is no difference in brace adherence fractions between the control arm and the experimental arm during the study's intervention period. In this test, brace wear was measured by iButton temperature sensors.||||0.23
72486299|NCT05293743|144500577|EQUIVALENCE|This analysis uses Welch's t-tests to calculate statistical significance, given the different variances and sample sizes of the populations.||||||0.86||||||The threshold for statistical significance was p = 0.05.|t-test, 2 sided|Degrees of Freedom = 6.68.||The null hypothesis is that there is no difference in brace adherence fractions when the experimental arm is wearing the Dynamic Bar versus the Standard Bar during the study period. In this test, brace wear was measured by parent-reported brace logs.||||0.86
72513350|NCT05373706|144556810|SUPERIORITY|Generalized linear mixed model was estimated using a sample of N=99 with a Condition × 2-Week Follow-Up interaction. AOC was the reference category for Condition, and Baseline was the reference category for 2-Week Follow-Up.|Count/Rate Ratio|0.95||||0.68|TWO_SIDED|95.0|0.76|1.2|||Generalized linear mixed model|Models controlled for sex assigned at birth, age, and student status (4-year vs. not) and used a Poisson error distribution.||Changes from Baseline to 2-Week Follow-Up for PFI versus AOC reported in this section.||1.20|0.76|0.68
72513351|NCT05373706|144556810|SUPERIORITY|Generalized linear mixed model was estimated using a sample of N=99 with a Condition × 3-Month Follow-Up interaction. AOC was the reference category for Condition, and Baseline was the reference category for 3-Month Follow-Up.|Count/Rate Ratio|1.1||||0.56|TWO_SIDED|95.0|0.81|1.49|||Generalized linear mixed model|Models controlled for sex assigned at birth, age, and student status (4-year vs. not) and used a Poisson error distribution.||Changes from Baseline to 3-Month Follow-Up for PFI versus AOC reported in this section.||1.49|0.81|0.56
72513352|NCT05373706|144556811|SUPERIORITY|Generalized linear mixed model was estimated using a sample of N=99 with a Condition × 2-Week Follow-Up interaction. AOC was the reference category for Condition, and Baseline was the reference category for 2-Week Follow-Up.|Count/Rate Ratio|0.93||||0.68|TWO_SIDED|95.0|0.64|1.33|||Generalized linear mixed model|Models controlled for sex assigned at birth, age, and student status (4-year vs. not) and used a Poisson error distribution.||Changes from Baseline to 2-Week Follow-Up for PFI versus AOC reported in this section.||1.33|0.64|0.68
72513353|NCT05373706|144556811|SUPERIORITY|Generalized linear mixed model was estimated using a sample of N=99 with a Condition × 3-Month Follow-Up interaction. AOC was the reference category for Condition, and Baseline was the reference category for 3-Month Follow-Up.|Count/Rate Ratio|1.24||||0.3|TWO_SIDED|95.0|0.82|1.88|||Generalized linear mixed model|Models controlled for sex assigned at birth, age, and student status (4-year vs. not) and used a Poisson error distribution.||Changes from Baseline to 3-Month Follow-Up for PFI versus AOC reported in this section.||1.88|0.82|0.30
72513354|NCT05373706|144556812|SUPERIORITY|Generalized linear mixed model was estimated using a sample of N=99 with a Condition × 2-Week Follow-Up interaction. AOC was the reference category for Condition, and Baseline was the reference category for 2-Week Follow-Up.|Count/Rate Ratio|0.89||||0.36|TWO_SIDED|95.0|0.69|1.15|||Generalized linear mixed model|Models controlled for sex assigned at birth, age, and student status (4-year vs. not) and used a Poisson error distribution.||Changes from Baseline to 2-Week Follow-Up for PFI versus AOC reported in this section.||1.15|0.69|0.36
72513355|NCT05373706|144556812|SUPERIORITY|Generalized linear mixed model was estimated using a sample of N=99 with a Condition × 3-Month Follow-Up interaction. AOC was the reference category for Condition, and Baseline was the reference category for 3-Month Follow-Up.|Count/Rate Ratio|1.05||||0.73|TWO_SIDED|95.0|0.8|1.38|||Generalized linear mixed model|Models controlled for sex assigned at birth, age, and student status (4-year vs. not) and used a Poisson error distribution.||Changes from Baseline to 3-Month Follow-Up for PFI versus AOC reported in this section.||1.38|0.80|0.73
72513356|NCT05373706|144556813|SUPERIORITY|Generalized linear mixed model was estimated using a sample of N=99 with a Condition × 2-Week Follow-Up interaction. AOC was the reference category for Condition, and Baseline was the reference category for 2-Week Follow-Up.|Count/Rate Ratio|0.83||||0.11|TWO_SIDED|95.0|0.66|1.04|||Generalized linear mixed model|Models controlled for sex assigned at birth, age, and student status (4-year vs. not) and used a Poisson error distribution.||Changes from Baseline to 2-Week Follow-Up for PFI versus AOC reported in this section.||1.04|0.66|0.11
72513357|NCT05373706|144556813|SUPERIORITY|Generalized linear mixed model was estimated using a sample of N=99 with a Condition × 3-Month Follow-Up interaction. AOC was the reference category for Condition, and Baseline was the reference category for 3-Month Follow-Up.|Count/Rate Ratio|0.88||||0.38|TWO_SIDED|95.0|0.66|1.17|||Generalized linear mixed model|Models controlled for sex assigned at birth, age, and student status (4-year vs. not) and used a Poisson error distribution.||Changes from Baseline to 3-Month Follow-Up for PFI versus AOC reported in this section.||1.17|0.66|0.38
72513358|NCT05086289|144556830|SUPERIORITY||Posterior Mean Difference|-0.38|||||TWO_SIDED|95.0|-0.89|0.13|||||Posterior mean difference with 95% credible interval is reported.|||0.13|-0.89|
72513359|NCT05086289|144556831|SUPERIORITY||Posterior Mean Difference|-0.28|||||TWO_SIDED|95.0|-0.85|0.3|||||Posterior mean difference with 95% credible interval is reported.|||0.30|-0.85|
72513360|NCT05086289|144556832|SUPERIORITY||Posterior Mean Difference|-0.62|||||TWO_SIDED|95.0|-1.91|0.68|||||Posterior mean difference with 95% credible interval is reported.|||0.68|-1.91|
72513361|NCT05086289|144556833|SUPERIORITY||Posterior Mean Difference|-1.17|||||TWO_SIDED|95.0|-2.54|0.18|||||Posterior mean difference with 95% credible interval is reported.|||0.18|-2.54|
72513362|NCT05086289|144556834|SUPERIORITY||Posterior Mean Difference|-0.12|||||TWO_SIDED|95.0|-0.44|0.19|||||Posterior mean difference with 95% credible interval is reported.|||0.19|-0.44|
72513363|NCT05086289|144556835|SUPERIORITY||Posterior Mean Difference|-0.26|||||TWO_SIDED|95.0|-0.67|0.14|||||Posterior mean difference with 95% credible interval is reported.|||0.14|-0.67|
72513364|NCT05086289|144556836|SUPERIORITY||Posterior Mean Difference|-0.48|||||TWO_SIDED|95.0|-1.05|0.09|||||Posterior mean difference with 95% credible interval is reported.|||0.09|-1.05|
72513365|NCT05086289|144556837|SUPERIORITY||Posterior Mean Difference|-0.51|||||TWO_SIDED|95.0|-1.17|0.16|||||Posterior mean difference with 95% credible interval is reported.|||0.16|-1.17|
72513366|NCT05086289|144556838|SUPERIORITY||Posterior Mean Difference|-4.95|||||TWO_SIDED|95.0|-11.07|1.27|||||Posterior mean difference with 95% credible interval is reported.|||1.27|-11.07|
72513367|NCT05086289|144556839|SUPERIORITY||Posterior Mean Difference|-4.78|||||TWO_SIDED|95.0|-11.73|2.15|||||Posterior mean difference with 95% credible interval is reported.|||2.15|-11.73|
72513368|NCT05086289|144556840|SUPERIORITY||Posterior Mean Difference|-0.13|||||TWO_SIDED|95.0|-0.46|0.21|||||Posterior mean difference with 95% credible interval is reported.|||0.21|-0.46|
72513369|NCT05086289|144556841|SUPERIORITY||Posterior Mean Difference|1.52|||||TWO_SIDED|95.0|-6.2|9.2|||||Posterior mean difference with 95% credible interval is reported.|||9.20|-6.20|
72513370|NCT05086289|144556842|SUPERIORITY||Posterior Mean Difference|0.0|||||TWO_SIDED|95.0|-0.06|0.07|||||Posterior mean difference with 95% credible interval is reported.|||0.07|-0.06|
72513371|NCT05086289|144556843|SUPERIORITY||Posterior Mean Difference|0.02|||||TWO_SIDED|95.0|-0.05|0.1|||||Posterior mean difference with 95% credible interval is reported.|||0.10|-0.05|
72513372|NCT05086289|144556844|SUPERIORITY||Posterior Mean Difference|41.72|||||TWO_SIDED|95.0|-95.92|179.76|||||Posterior mean difference with 95% credible interval is reported.|||179.76|-95.92|
72486300|NCT05293743|144500577|EQUIVALENCE|This analysis uses Welch's t-tests to calculate statistical significance, given the different variances and sample sizes of the populations.||||||0.21||||||The threshold for statistical significance was p = 0.05.|t-test, 2 sided|Degrees of Freedom = 6.94.||The null hypothesis is that there is no difference in brace adherence fractions when the experimental arm is wearing the Dynamic Bar versus the Standard Bar during the study period. In this test, brace wear was measured by iButton temperature sensors.||||0.21
72486301|NCT04376827|144500608|SUPERIORITY||Hazard Ratio (HR)|0.62||||0.7807|TWO_SIDED|80.0|0.27|1.41|||log-rank test||Hazard ratio and 80% CI: estimated by Cox proportional hazards model adjusting for baseline UPCR level (\<3 mg/mg and \>=3 mg/mg).|||1.41|0.27|0.7807
72486302|NCT04376827|144500609|SUPERIORITY||Hazard Ratio (HR)|1.52||||0.4654|TWO_SIDED|80.0|0.62|3.85|||long-rank test||Hazard ratio and 80% CI: estimated by Cox proportional hazards model adjusting for baseline UPCR level (\<3 mg/mg and \>=3 mg/mg).|||3.85|0.62|0.4654
72486303|NCT04415658|144500691|SUPERIORITY||Risk Ratio (RR)|1.01||||0.57|TWO_SIDED|95.0|0.97|1.07|||Chi-squared, Corrected|||80% power to detect a 10% increase in hearts transplanted||1.07|0.97|0.57
72486304|NCT04415658|144500692|NON_INFERIORITY|Six percent margin, assuming 96% graft survival in control group|Mean Difference (Final Values)|1.9|||<|0.001|TWO_SIDED|95.0|-2.3|6.0|||Regression, Logistic|||Non-inferiority analysis for thyroxine vs saline||6.0|-2.3|<0.001
72486305|NCT01480284|144500739|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was judged based on the one-sided test of the model, y(Δ) = Baseline + Group ( Δ= -1.0). The adjusted mean values of the TDF group and the ETV group were calculated, and the adjusted mean value and two-sided 95% confidence interval of differences between the TDF group and the ETV group were calculated. Non-inferiority was also to be confirmed when the upper limit of the calculated two-sided 95% confidence interval was less than the non-inferiority limit value of 1.0|Mean Difference (Final Values)|-0.13|||<|0.0001|TWO_SIDED|95.0|-0.28|0.02||p-value was compared with the significance level of 0.025|ANCOVA|||||0.02|-0.28|<0.0001
72486306|NCT01480284|144500740|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01|||||TWO_SIDED|95.0|-0.4|0.39|||||CI and estimate difference is provided for change from Baseline in serum HBV DNA level at Week 48.|||0.39|-0.40|
72486307|NCT00709111|144500751|SUPERIORITY_OR_OTHER|||||||0.97||||||The p-value is one-sided with a nominal level of 0.05.|Wilcoxon signed-rank, 1-sided|||The change in CD4+ T-cell count from baseline to week 24 was compared against the null hypothesis of change \<20 cells/mm\^3. The study was powered to yield 80% power to show that there was \>=20 cells/mm\^3 increase in CD4+ T-cell count assuming an underlying change in CD4+ T-cell counts induced by MVC of 50 cells/mm\^3, a standard deviation of 60 cells/mm\^3 around the mean CD4+ T-cell count change, 10% lost-to-follow-up or premature MVC discontinuation rate, and one-sided type 1 error of 0.05.||||0.97
72486308|NCT02716675|144500797|OTHER||Prevention Efficacy (PE)|26.6||||0.15|TWO_SIDED|95.0|-11.7|51.8||The threshold for statistical significance was p = 0.05.|wald|||The primary PE analysis tests the null hypothesis PE equal to zero versus the alternative hypothesis PE not equal to zero using a 2-sided alpha equal 0.05 level Wald test of the equality of log cumulative hazard functions at the week 80 visit for the pooled VRC01 group versus the placebo group.||51.8|-11.7|0.15
72486309|NCT02716675|144500797|OTHER||Prevention Efficacy (PE)|22.4|||||TWO_SIDED|95.0|-25.5|52.0||||||A secondary analysis assesses the overall PE of the low-dose VRC01 group versus the placebo group.||52.0|-25.5|
72513373|NCT05086289|144556845|SUPERIORITY||Posterior Mean Difference|9.73|||||TWO_SIDED|95.0|-151.11|170.52|||||Posterior mean difference with 95% credible interval is reported.|||170.52|-151.11|
72486310|NCT02716675|144500797|OTHER||Prevention Efficacy (PE)|30.9|||||TWO_SIDED|95.0|-13.9|58.0||||||A secondary analysis assesses the overall PE of the high-dose VRC01 group versus the placebo group.||58.0|-13.9|
72486311|NCT02716675|144500799|OTHER||Prevention Efficacy (PE)|73.0|||||TWO_SIDED|95.0|27.6|89.9||||||PE against IC80 of least sensitive variant less than 1||89.9|27.6|
72486312|NCT02716675|144500799|OTHER||Prevention Efficacy (PE)|6.1|||||TWO_SIDED|95.0|-174.3|67.8||||||PE against IC80 of least sensitive variant 1-3||67.8|-174.3|
72486313|NCT02716675|144500799|OTHER||Prevention Efficacy (PE)|8.6|||||TWO_SIDED|95.0|-68.1|50.3||||||PE against IC80 of least sensitive variant \> 3||50.3|-68.1|
72486314|NCT01312038|144500905|SUPERIORITY_OR_OTHER||||||=|0.93|||||||Paired T-test|df=34||Comparison of the simethicone and placebo groups with respect to the difference between the pre-post treatment FGE at ME-pressure chamber gradient of -200 daPa.||||=0.93
72486315|NCT01312038|144500905|SUPERIORITY_OR_OTHER||||||=|0.39|||||||Paired T-test|df = 31||Comparison of the simethicone and placebo groups with respect to the difference between the pre-post treatment FGE at ME-pressure chamber gradient of 200 daPa.||||=0.39
72486316|NCT02665052|144500916|SUPERIORITY|||||||0.64||||||The primary analysis was a two sample t-test (alpha=0.05) of the mean WMFT log-time change at 6 weeks. The threshold for statistical significance was p-value = 0.05.|t-test, 2 sided|||78 participants were needed to generate a sample size of 22 per group and provide 80% power to detect a between group difference in mean Wolf time change (6 week - baseline) based on an a priori assumption of a mean change of 0 and 7.4 seconds respectively for the delayed entry usual care control and home-based BATRAC group; a SD of 7.6 and discontinuation rate of 15%.||||0.64
72486317|NCT02665052|144500917|SUPERIORITY|||||||0.01||||||The lab-based group had significant within group mean Fugl-Meyer (FM) change at week 6.|ANOVA|Dunnett's adjustments were used to compare the active intervention changes to the delayed-entry usual care control group.||Within group changes from baseline to week 6 were assessed using analysis of variance.||||0.01
72486318|NCT02665052|144500917|SUPERIORITY|||||||0.97|||||||ANOVA|||FM change was analyzed using analysis of variance followed by Dunnett's adjustment for between group comparisons in the home-based BATRAC group compared to the delayed-entry control.||||0.97
72513374|NCT03150108|144556848|EQUIVALENCE|Welch's t-test with Satterthwaite's approximation to the degrees of freedom was used to compare the log transformed Cmax values of both ethnic groups at 100 mcg dose and the results were back-transformed to get the estimates for the geometric means and for the ratio of geometric means (Japanese/Caucasian), and 90% confidence interval (CI).|Geometric mean ratio|1.119|||||TWO_SIDED|90.0|0.875|1.43||||||||1.430|0.875|
72567781|NCT00922272|144667224|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.6||||0.1975|TWO_SIDED|95.0|-0.3|1.5|||ANCOVA|||Positive subscale||1.5|-0.3|0.1975
72567782|NCT00922272|144667224|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.0||||0.1228|TWO_SIDED|95.0|-0.3|2.3|||ANCOVA|||Negative subscale||2.3|-0.3|0.1228
72402770|NCT01480076|144311693|SUPERIORITY_OR_OTHER|||||||0.6128|||||||mixed effect model|||Overall, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D index scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.6128
72402771|NCT01480076|144311693|SUPERIORITY_OR_OTHER||difference of LS means|0.05|STANDARD_ERROR_OF_MEAN|0.02||0.0331|TWO_SIDED||||||mixed effect model|||Overall, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D index scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0331
72402772|NCT01480076|144311693|SUPERIORITY_OR_OTHER||difference of LS means|0.05|STANDARD_ERROR_OF_MEAN|0.04||0.1919|TWO_SIDED||||||mixed effect model|||Overall, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D index scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.1919
72402773|NCT01480076|144311693|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 3, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D index scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
72486319|NCT02665052|144500918|SUPERIORITY|||||||0.31|||||||ANOVA|||Within group SIS hand changes from baseline to week 6 were assessed using analysis of variance followed by comparisons to the delayed-entry usual care control using Dunnett's adjustment.||||0.31
72486320|NCT00823823|144500919|SUPERIORITY_OR_OTHER|||||||1|||||||Chi-squared|||The frequency of loss of reduction during the study period was compared across casting groups using a two-sided chi-square test with alpha = 0.05.||||1.00
72486321|NCT02234284|144500921|SUPERIORITY||Mean Difference (Final Values)|0.14||||0.35|TWO_SIDED|95.0|-0.15|0.43|||Mixed Models Analysis|Outcomes were by group assignment (intention to treat) using generalized linear models adjusted for baseline levels of variable and clustering.|Value is for mean score of participants in Health Coached arm minus mean score in Usual Care, adjusted for baseline values and for clustering.|Outcomes were compared by group assignment using generalized linear models (GLMs) with a normal distribution for continuous outcomes), Poisson distribution for count outcomes (e.g. exacerbations and hospitalizations), and binomial distribution for binary outcomes. In all models, baseline levels of the outcome were entered as a predictor and follow-up levels as the dependent variable, with use of a robust standard error to account for clustering.||.43|-.15|.35
72486322|NCT02234284|144500922|SUPERIORITY||Mean Difference (Net)|0.26||||0.2|TWO_SIDED|95.0|-0.13|0.65|||Mixed Models Analysis|Outcomes were by group assignment (intention to treat) using generalized linear models adjusted for baseline levels of variable and clustering.|Value is for mean score of participants in Health Coached arm minus mean score in Usual Care, adjusted for baseline values and for clustering.|Outcomes were compared by group assignment using generalized linear models (GLMs) with a normal distribution for continuous outcomes), Poisson distribution for count outcomes (e.g. exacerbations and hospitalizations), and binomial distribution for binary outcomes. In all models, baseline levels of the outcome were entered as a predictor and follow-up levels as the dependent variable, with use of a robust standard error to account for clustering.||.65|-.13|.20
72486323|NCT02234284|144500923|SUPERIORITY||Mean Difference (Final Values)|-0.21||||0.13|TWO_SIDED|95.0|-0.49|0.07|||Mixed Models Analysis|Outcomes were by group assignment (intention to treat) using generalized linear models adjusted for baseline levels of variable and clustering.|Value is for rate of exacerbations for participants in Health Coached arm minus rate for Usual Care, adjusted for baseline values and for clustering.|Outcomes were compared by group assignment using generalized linear models (GLMs) with a normal distribution for continuous outcomes), Poisson distribution for count outcomes (e.g. exacerbations and hospitalizations), and binomial distribution for binary outcomes. In all models, baseline levels of the outcome were entered as a predictor and follow-up levels as the dependent variable, with use of a robust standard error to account for clustering.||0.07|-0.49|.13
72513375|NCT03150108|144556848|OTHER|Dose proportionality|Increase in Cmax per Dose Doubling|1.76|||||TWO_SIDED|90.0|1.52|2.03|||||Linear model of log transformed PK parameters at all doses in Japanese descent, including log transformed dose, period, sequence as fixed effects, and intercept as a random effect accounting for each participant within sequence as their own control.|Dose proportionality was assessed for baseline-adjusted Cmax using the power model. The power model assumes a linear relationship between the natural log transformed parameter and the natural log transformed dose. The fold increase in PK parameters with doubling the dose and the 90% CIs were calculated.||2.03|1.52|
72513376|NCT03150108|144556850|EQUIVALENCE|Welch's t-test with Satterthwaite's approximation to the degrees of freedom was used to compare the log transformed AUClast values of both ethnic groups at 100 mcg dose and the results were back-transformed to get the estimates for the geometric means and for the ratio of geometric means (Japanese/Caucasian), and 90% CI.|Geometric mean ratio|0.99|||||TWO_SIDED|90.0|0.8|1.23||||||||1.23|0.80|
72513377|NCT03150108|144556850|OTHER|Dose proportionality|Increase in AUClast per Dose Doubling|2.35||||||90.0|2.06|2.7|||||Linear model of log transformed PK parameters at all doses in Japanese descent, including log transformed dose, period, sequence as fixed effects, and intercept as a random effect accounting for each participant within sequence as their own control.|Dose proportionality was assessed for baseline-adjusted AUClast using the power model. The power model assumes a linear relationship between the natural log transformed parameter and the natural log transformed dose. The fold increase in PK parameters with doubling the dose and the 90% CIs were calculated.||2.70|2.06|
72567783|NCT00922272|144667224|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.8||||0.1115|TWO_SIDED|95.0|-0.4|3.9|||ANCOVA|||General Psychopathology subscale||3.9|-0.4|0.1115
72567784|NCT00922272|144667231|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0307||95.0|||||t-test, 2 sided|||||||0.0307
72402774|NCT01480076|144311693|SUPERIORITY_OR_OTHER|||||||0.4481|||||||mixed effect model|||Month 3, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D index scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.4481
72402775|NCT01480076|144311693|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 3, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D index scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
72486324|NCT02234284|144500924|SUPERIORITY||Mean Difference (Final Values)|8.53||||0.32|TWO_SIDED|95.0|-8.18|25.26|||Mixed Models Analysis|Outcomes were by group assignment (intention to treat) using generalized linear models adjusted for baseline levels of variable and clustering.||Outcomes were compared by group assignment using generalized linear models (GLMs) with a normal distribution for continuous outcomes), Poisson distribution for count outcomes (e.g. exacerbations and hospitalizations), and binomial distribution for binary outcomes. In all models, baseline levels of the outcome were entered as a predictor and follow-up levels as the dependent variable, with use of a robust standard error to account for clustering.|Value is for mean distance (in meters) of participants in Health Coached arm minus mean distance in Usual Care, adjusted for baseline values and for clustering.|25.26|-8.18|.32
72486325|NCT02234284|144500925|SUPERIORITY||Mean Difference (Final Values)|0.3||||0.27|TWO_SIDED|95.0|-0.23|0.83|||Mixed Models Analysis|Outcomes were by group assignment (intention to treat) using generalized linear models adjusted for baseline levels of variable and clustering.|Value is for mean score of participants in Health Coached arm minus mean score in Usual Care, adjusted for baseline values and for clustering.|Outcomes were compared by group assignment using generalized linear models (GLMs) with a normal distribution for continuous outcomes), Poisson distribution for count outcomes (e.g. exacerbations and hospitalizations), and binomial distribution for binary outcomes. In all models, baseline levels of the outcome were entered as a predictor and follow-up levels as the dependent variable, with use of a robust standard error to account for clustering.||.83|-.23|.27
72486326|NCT02234284|144500926|SUPERIORITY||Mean Difference (Final Values)|0.38||||0.02|TWO_SIDED|95.0|0.07|0.68|||Mixed Models Analysis|Outcomes were by group assignment (intention to treat) using generalized linear models adjusted for baseline levels of variable and clustering.|Value is for mean score of participants in Health Coached arm minus mean score in Usual Care, adjusted for baseline values and for clustering.|Outcomes were compared by group assignment using generalized linear models (GLMs) with a normal distribution for continuous outcomes), Poisson distribution for count outcomes (e.g. exacerbations and hospitalizations), and binomial distribution for binary outcomes. In all models, baseline levels of the outcome were entered as a predictor and follow-up levels as the dependent variable, with use of a robust standard error to account for clustering.||.68|.07|.02
72513378|NCT03150108|144556851|EQUIVALENCE|Welch's t-test with Satterthwaite's approximation to the degrees of freedom was used to compare the log transformed AUC0-8 values of both ethnic groups at 100 mcg dose and the results were back-transformed to get the estimates for the geometric means and for the ratio of geometric means (Japanese/Caucasian), and 90% CI.|Geometric mean ratio|1.08|||||TWO_SIDED|90.0|0.87|1.35||||||||1.35|0.87|
72513379|NCT03150108|144556851|OTHER|Dose proportionality|Increase in AUC0-8 per Dose Doubling|2.23|||||TWO_SIDED|90.0|1.98|2.51|||||Linear model of log transformed PK parameters at all doses in Japanese descent, including log transformed dose, period, sequence as fixed effects, and intercept as a random effect accounting for each participant within sequence as their own control.|Dose proportionality was assessed for baseline-adjusted AUC0-8 using the power model. The power model assumes a linear relationship between the natural log transformed parameter and the natural log transformed dose. The fold increase in PK parameters with doubling the dose and the 90% CIs were calculated.||2.51|1.98|
72513380|NCT03150108|144556852|EQUIVALENCE|Welch's t-test with Satterthwaite's approximation to the degrees of freedom was used to compare the log transformed AUC0-inf values of both ethnic groups at 100 mcg dose and the results were back-transformed to get the estimates for the geometric means and for the ratio of geometric means (Japanese/Caucasian), and 90% CI.|Geometric mean ratio|1.01|||||TWO_SIDED|90.0|0.77|1.33||||||||1.33|0.77|
72513381|NCT03150108|144556852|OTHER|Dose proportionality|Increase in AUC0-inf per Dose Doubling|2.31|||||TWO_SIDED|90.0|1.96|2.71|||||Linear model of log transformed PK parameters at all doses in Japanese descent, including log transformed dose, period, sequence as fixed effects, and intercept as a random effect accounting for each participant within sequence as their own control.|Dose proportionality was assessed for baseline-adjusted AUC0-inf using the power model. The power model assumes a linear relationship between the natural log transformed parameter and the natural log transformed dose. The fold increase in PK parameters with doubling the dose and the 90% CIs were calculated.||2.71|1.96|
72513382|NCT03150108|144556858|EQUIVALENCE|Welch's t-test with Satterthwaite's approximation to the degrees of freedom was used to compare the log transformed Cmax values of both ethnic groups at 100 mcg dose and the results were back-transformed to get the estimates for the geometric means and for the ratio of geometric means (Japanese/Caucasian), and 90% CI.|Geometric Mean Ratio|1.13|||||TWO_SIDED|90.0|0.9|1.4||||||||1.40|0.90|
72513383|NCT03150108|144556860|EQUIVALENCE|Welch's t-test with Satterthwaite's approximation to the degrees of freedom was used to compare the log transformed Cmax values of both ethnic groups at 100 mcg dose and the results were back-transformed to get the estimates for the geometric means and for the ratio of geometric means (Japanese/Caucasian), and 90% CI.|Geometric Mean Ratio|1.08|||||TWO_SIDED|90.0|0.93|1.25||||||||1.25|0.93|
72513384|NCT01975935|144556869|SUPERIORITY|||||||0.05||||||This is the calculated p value and not the threshold for statistical significance.|t-test, 2 sided|||||||0.05
72513385|NCT01975935|144556870|SUPERIORITY|||||||0.38|||||||t-test, 2 sided|||||||0.38
72513386|NCT01975935|144556871|SUPERIORITY|||||||0.51|||||||t-test, 2 sided|||||||0.51
72567785|NCT00922272|144667232|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.8||||0.1072|TWO_SIDED|95.0|-0.6|6.2|||ANCOVA|||||6.2|-0.6|0.1072
72567786|NCT00922272|144667233|SUPERIORITY_OR_OTHER_LEGACY|||||||0.366||95.0|||||t-test, 2 sided|||||||0.3660
72567787|NCT00922272|144667234|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.4||||0.4347|TWO_SIDED|95.0|-5.0|2.2|||ANCOVA|||||2.2|-5.0|0.4347
72486327|NCT02234284|144500927|SUPERIORITY||Mean Difference (Final Values)|-0.83||||0.4|TWO_SIDED|95.0|-2.78|1.12|||Mixed Models Analysis|Outcomes were by group assignment (intention to treat) using generalized linear models adjusted for baseline levels of variable and clustering.|Value is for mean score of participants in Health Coached arm minus mean score in Usual Care, adjusted for baseline values and for clustering.|Outcomes were compared by group assignment using generalized linear models (GLMs) with a normal distribution for continuous outcomes), Poisson distribution for count outcomes (e.g. exacerbations and hospitalizations), and binomial distribution for binary outcomes. In all models, baseline levels of the outcome were entered as a predictor and follow-up levels as the dependent variable, with use of a robust standard error to account for clustering.||1.12|-2.78|.40
72486328|NCT02234284|144500928|SUPERIORITY||Mean Difference (Net)|0.0||||0.98|TWO_SIDED|95.0|-3.0|3.0|||Mixed Models Analysis|Outcomes were by group assignment (intention to treat) using generalized linear models adjusted for baseline levels of variable and clustering.|Value is for mean percent predicted of participants in Health Coached arm minus mean percent predicted in Usual Care, adjusted for baseline values and for clustering.|Outcomes were compared by group assignment using generalized linear models (GLMs) with a normal distribution for continuous outcomes), Poisson distribution for count outcomes (e.g. exacerbations and hospitalizations), and binomial distribution for binary outcomes. In all models, baseline levels of the outcome were entered as a predictor and follow-up levels as the dependent variable, with use of a robust standard error to account for clustering.||3|-3|.98
72486329|NCT02234284|144500929|SUPERIORITY||Mean Difference (Final Values)|-11.5||||0.3|TWO_SIDED|95.0|-33.3|10.2|||Mixed Models Analysis|Outcomes were by group assignment (intention to treat) using generalized linear models adjusted for baseline levels of variable and clustering.|Value is for proportion (%) of participants in Health Coached arm minus proportion in Usual Care, adjusted for baseline values and for clustering.|Outcomes were compared by group assignment using generalized linear models (GLMs) with a normal distribution for continuous outcomes), Poisson distribution for count outcomes (e.g. exacerbations and hospitalizations), and binomial distribution for binary outcomes. In all models, baseline levels of the outcome were entered as a predictor and follow-up levels as the dependent variable, with use of a robust standard error to account for clustering.||10.2|-33.3|.30
72486330|NCT02234284|144500930|SUPERIORITY||Mean Difference (Final Values)|-0.73||||0.29|TWO_SIDED|95.0|-2.07|0.62|||Mixed Models Analysis||Value is for mean number of days for participants in Health Coached arm minus mean score in Usual Care, adjusted for baseline values and for clustering.|||0.62|-2.07|.29
72486331|NCT02234284|144500931|SUPERIORITY||Mean Difference (Final Values)|39.7|||<|0.001|TWO_SIDED|95.0|19.6|59.8|||Mixed Models Analysis|Outcomes were by group assignment (intention to treat) using generalized linear models adjusted for baseline levels of variable and clustering.|Value is for proportion (%) of participants in Health Coached arm minus proportion in Usual Care, adjusted for baseline values and for clustering.|Outcomes were compared by group assignment using generalized linear models (GLMs) with a normal distribution for continuous outcomes), Poisson distribution for count outcomes (e.g. exacerbations and hospitalizations), and binomial distribution for binary outcomes. In all models, baseline levels of the outcome were entered as a predictor and follow-up levels as the dependent variable, with use of a robust standard error to account for clustering.||59.8|19.6|<.001
72486332|NCT02234284|144500932|SUPERIORITY||Mean Difference (Final Values)|7.8||||0.38|TWO_SIDED|95.0|-9.5|25.2|||Mixed Models Analysis||Value is for proportion of participants in Health Coached arm minus proportion in Usual Care, adjusted for baseline values and for clustering.|Outcomes were compared by group assignment using generalized linear models (GLMs) with a normal distribution for continuous outcomes), Poisson distribution for count outcomes (e.g. exacerbations and hospitalizations), and binomial distribution for binary outcomes. In all models, baseline levels of the outcome were entered as a predictor and follow-up levels as the dependent variable, with use of a robust standard error to account for clustering.||25.2|-9.5|.38
72486333|NCT02234284|144500933|SUPERIORITY||Median Difference (Final Values)|2.0||||0.73|TWO_SIDED|95.0|-9.4|13.4|||Mixed Models Analysis|Outcomes were by group assignment (intention to treat) using generalized linear models adjusted for baseline levels of variable and clustering.||Outcomes were compared by group assignment using generalized linear models (GLMs) with a normal distribution for continuous outcomes), Poisson distribution for count outcomes (e.g. exacerbations and hospitalizations), and binomial distribution for binary outcomes. In all models, baseline levels of the outcome were entered as a predictor and follow-up levels as the dependent variable, with use of a robust standard error to account for clustering.||13.4|-9.4|.73
72486334|NCT02234284|144500934|SUPERIORITY||Mean Difference (Final Values)|3.4||||0.7|TWO_SIDED|95.0|-14.0|20.8|||Mixed Models Analysis|Outcomes were by group assignment (intention to treat) using generalized linear models adjusted for baseline levels of variable and clustering.|Value is for proportion (%) of participants in Health Coached arm minus proportion in Usual Care, adjusted for baseline values and for clustering.|Outcomes were compared by group assignment using generalized linear models (GLMs) with a normal distribution for continuous outcomes), Poisson distribution for count outcomes (e.g. exacerbations and hospitalizations), and binomial distribution for binary outcomes. In all models, baseline levels of the outcome were entered as a predictor and follow-up levels as the dependent variable, with use of a robust standard error to account for clustering.||20.8|-14.0|.70
72486335|NCT02234284|144500935|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.97|TWO_SIDED|95.0|-5.5|5.3|||Mixed Models Analysis|Outcomes were by group assignment (intention to treat) using generalized linear models adjusted for baseline levels of variable and clustering.|Value is for proportion (%) of participants in Health Coached arm minus proportion in Usual Care, adjusted for baseline values and for clustering.|Outcomes were compared by group assignment using generalized linear models (GLMs) with a normal distribution for continuous outcomes), Poisson distribution for count outcomes (e.g. exacerbations and hospitalizations), and binomial distribution for binary outcomes. In all models, baseline levels of the outcome were entered as a predictor and follow-up levels as the dependent variable, with use of a robust standard error to account for clustering.||5.3|-5.5|.97
72567788|NCT00922272|144667235|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4312||95.0|||||t-test, 2 sided|||||||0.4312
72567789|NCT00922272|144667236|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.5||||0.0874|TWO_SIDED|95.0|-5.4|0.4|||ANCOVA|||||0.4|-5.4|0.0874
72567790|NCT00922272|144667237|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||t-test, 2 sided|||Total Skills||||<0.0001
72486336|NCT02234284|144500936|SUPERIORITY||Mean Difference (Final Values)|0.48||||0.52|TWO_SIDED|95.0|-0.32|1.28|||Mixed Models Analysis|Outcomes were by group assignment (intention to treat) using generalized linear models adjusted for baseline levels of variable and clustering.|Value is for rate of outpatient visits for participants in Health Coached arm minus rate for Usual Care, adjusted for baseline values and for clustering.|Outcomes were compared by group assignment using generalized linear models (GLMs) with a normal distribution for continuous outcomes), Poisson distribution for count outcomes (e.g. exacerbations and hospitalizations), and binomial distribution for binary outcomes. In all models, baseline levels of the outcome were entered as a predictor and follow-up levels as the dependent variable, with use of a robust standard error to account for clustering.||1.28|-0.32|.52
72486337|NCT02234284|144500937|SUPERIORITY||Mean Difference (Final Values)|-0.05||||0.78|TWO_SIDED|95.0|-0.32|0.22|||Mixed Models Analysis||Value is for rate of COPD-related ED visits for participants in Health Coached arm minus rate for Usual Care, adjusted for baseline values and for clustering.|Outcomes were compared by group assignment using generalized linear models (GLMs) with a normal distribution for continuous outcomes), Poisson distribution for count outcomes (e.g. exacerbations and hospitalizations), and binomial distribution for binary outcomes. In all models, baseline levels of the outcome were entered as a predictor and follow-up levels as the dependent variable, with use of a robust standard error to account for clustering.||0.22|-0.32|.78
72486338|NCT02234284|144500938|SUPERIORITY||Mean Difference (Final Values)|-0.08||||0.8|TWO_SIDED|95.0|-0.56|0.4|||Mixed Models Analysis|Outcomes were by group assignment (intention to treat) using generalized linear models adjusted for baseline levels of variable and clustering.|Value is for rate of non-COPD-related ED visits for participants in Health Coached arm minus rate for Usual Care, adjusted for baseline values and for clustering.|Outcomes were compared by group assignment using generalized linear models (GLMs) with a normal distribution for continuous outcomes), Poisson distribution for count outcomes (e.g. exacerbations and hospitalizations), and binomial distribution for binary outcomes. In all models, baseline levels of the outcome were entered as a predictor and follow-up levels as the dependent variable, with use of a robust standard error to account for clustering.||0.40|-0.56|.80
72486339|NCT02234284|144500939|SUPERIORITY||Mean Difference (Final Values)|-0.13||||0.35|TWO_SIDED|95.0|-0.32|0.06|||Mixed Models Analysis|Outcomes were by group assignment (intention to treat) using generalized linear models adjusted for baseline levels of variable and clustering.|Value is for rate of COPD-related hospital visits for participants in Health Coached arm minus rate for Usual Care, adjusted for baseline values and for clustering.|Outcomes were compared by group assignment using generalized linear models (GLMs) with a normal distribution for continuous outcomes), Poisson distribution for count outcomes (e.g. exacerbations and hospitalizations), and binomial distribution for binary outcomes. In all models, baseline levels of the outcome were entered as a predictor and follow-up levels as the dependent variable, with use of a robust standard error to account for clustering.||0.06|-0.32|.35
72513387|NCT00807846|144556878|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.1||||0.274|TWO_SIDED|90.0|-0.56|2.76|||ANCOVA|||The primary analysis was based on 90% confidence interval (CI) for the difference across treatment groups (celecoxib - naproxen) in mean change from baseline in SBP. Change from Baseline in BP was analyzed using analysis of covariance (ANCOVA) with model terms for treatment with baseline height, baseline weight, baseline age, and baseline SBP as covariates. No formal hypothesis testing was applied to the primary analysis.||2.76|-0.56|0.274
72513388|NCT00807846|144556879|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.088||||0.148|TWO_SIDED|95.0|-0.39|2.57|||ANCOVA|||For secondary analyses, 95% CIs for the differences across treatment groups (celecoxib - naproxen) in the mean change from baseline were generated. The change from baseline in BP was analyzed using an ANCOVA model with terms for treatment, baseline height, weight, age and baseline BP as covariates. Secondary analyses were conducted using a two-sided test with α=0.05.||2.57|-0.39|0.148
72513389|NCT00807846|144556880|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.837||||0.027|TWO_SIDED|95.0|0.21|3.46|||ANCOVA|||"For secondary analyses, 95% CIs for the differences across treatment groups (celecoxib - naproxen) in the mean change from baseline were generated. The change from baseline in blood pressure was analyzed using an ANCOVA model with terms for treatment, baseline height, weight, age and baseline BP as covariates.~Secondary analyses were conducted using a two-sided test with α=0.05."||3.46|0.21|0.027
72513390|NCT00807846|144556881|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.207||||0.106|TWO_SIDED|95.0|-2.67|0.26|||ANCOVA|||For secondary analyses, 95% CIs for the differences across treatment groups (celecoxib - naproxen) in the mean change from baseline were generated. The change from baseline in BP was analyzed using an ANCOVA model with terms for treatment, baseline height, weight, age and baseline BP as covariates. Secondary analyses were conducted using a two-sided test with α=0.05.||0.26|-2.67|0.106
72513391|NCT00807846|144556882|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.22||||0.776|TWO_SIDED|95.0|-1.3|1.74|||ANCOVA|||For secondary analyses, 95% CIs for the differences across treatment groups (celecoxib - naproxen) in the mean change from baseline were generated. The change from baseline in BP was analyzed using an ANCOVA model with terms for treatment, baseline height, weight, age and baseline BP as covariates. Secondary analyses were conducted using a two-sided test with α=0.05.||1.74|-1.30|0.776
72513392|NCT00807846|144556883|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.179||||0.815|TWO_SIDED|95.0|-1.69|1.33|||ANCOVA|||For secondary analyses, 95% CIs for the differences across treatment groups (celecoxib - naproxen) in the mean change from baseline were generated. The change from baseline in BP was analyzed using an ANCOVA model with terms for treatment, baseline height, weight, age and baseline blood pressure as covariates. Secondary analyses were conducted using a two-sided test with α=0.05.||1.33|-1.69|0.815
72513393|NCT00807846|144556884|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.033||||0.303|TWO_SIDED|95.0|-2.76|8.82|||ANCOVA|||Change from Baseline to Week 6 was analyzed using ANCOVA model as well with treatment and Baseline value as a covariate. The LS mean change from Baseline was compared between treatment groups and an appropriate p-value and 95% CI for the difference between the two treatment groups was generated. This analysis was conducted using a two-sided test with α=0.05.||8.82|-2.76|0.303
72567791|NCT00922272|144667237|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0002||95.0|||||t-test, 2 sided|||Communication Skills||||0.0002
72567792|NCT00922272|144667237|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0028||95.0|||||t-test, 2 sided|||Financial Skills||||0.0028
72567793|NCT00922272|144667238|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.4||||0.4637|TWO_SIDED|95.0|-5.3|2.4|||ANCOVA|||Total Skills||2.4|-5.3|0.4637
72486340|NCT02234284|144500940|SUPERIORITY||Mean Difference (Final Values)|-0.08||||0.37|TWO_SIDED|95.0|-0.2|0.04|||Mixed Models Analysis|Outcomes were by group assignment (intention to treat) using generalized linear models adjusted for baseline levels of variable and clustering.|Value is for rate of non-COPD-related hospitalizations for participants in Health Coached arm minus rate for Usual Care, adjusted for baseline values and for clustering.|Outcomes were compared by group assignment using generalized linear models (GLMs) with a normal distribution for continuous outcomes), Poisson distribution for count outcomes (e.g. exacerbations and hospitalizations), and binomial distribution for binary outcomes. In all models, baseline levels of the outcome were entered as a predictor and follow-up levels as the dependent variable, with use of a robust standard error to account for clustering.||0.04|-0.20|.37
72567794|NCT00922272|144667238|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.8||||0.6137|TWO_SIDED|95.0|-4.1|2.4|||ANCOVA|||Communication Skills||2.4|-4.1|0.6137
72486341|NCT02234284|144500941|SUPERIORITY||difference in proportion|-18.9||||0.01|TWO_SIDED|95.0|-33.1|-4.8|||Mixed Models Analysis|Outcomes were by group assignment (intention to treat) using generalized linear models adjusted for baseline levels of variable and clustering.|Value is for proportion (%) of participants in Health Coached arm minus proportion in Usual Care, adjusted for baseline values and for clustering.|Outcomes were compared by group assignment using generalized linear models (GLMs) with a normal distribution for continuous outcomes), Poisson distribution for count outcomes (e.g. exacerbations and hospitalizations), and binomial distribution for binary outcomes. In all models, baseline levels of the outcome were entered as a predictor and follow-up levels as the dependent variable, with use of a robust standard error to account for clustering.||-4.8|-33.1|.01
72486342|NCT02234284|144500942|SUPERIORITY||Mean Difference (Final Values)|14.6||||0.01|TWO_SIDED|95.0|3.3|25.9|||Mixed Models Analysis||Value is for proportion (%) of participants in Health Coached arm minus proportion in Usual Care, adjusted for baseline values and for clustering.|Outcomes were compared by group assignment using generalized linear models (GLMs) with a normal distribution for continuous outcomes), Poisson distribution for count outcomes (e.g. exacerbations and hospitalizations), and binomial distribution for binary outcomes. In all models, baseline levels of the outcome were entered as a predictor and follow-up levels as the dependent variable, with use of a robust standard error to account for clustering.||25.9|3.3|.01
72486343|NCT01495858|144500947|SUPERIORITY_OR_OTHER|||||||0.3047|||||||ANCOVA|||||||0.3047
72486344|NCT01495858|144500948|SUPERIORITY_OR_OTHER|||||||0.1677|||||||Log Rank|||||||0.1677
72486345|NCT01495858|144500949|SUPERIORITY_OR_OTHER|||||||0.2764|||||||ANCOVA|||||||0.2764
72486346|NCT01495858|144500950|SUPERIORITY_OR_OTHER|||||||0.2764|||||||ANCOVA|||||||0.2764
72486347|NCT01495858|144500951|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
72486348|NCT01495858|144500952|SUPERIORITY_OR_OTHER|||||||0.0004|||||||Cochran-Mantel-Haenszel|||||||0.0004
72486349|NCT01495858|144500953|SUPERIORITY_OR_OTHER|||||||0.0145|||||||Cochran-Mantel-Haenszel|||||||0.0145
72486350|NCT01495858|144500954|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Cochran-Mantel-Haenszel|||||||>0.05
72567795|NCT00922272|144667238|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.1||||0.3482|TWO_SIDED|95.0|-3.5|1.3|||ANCOVA|||Financial Skills||1.3|-3.5|0.3482
72567796|NCT00922272|144667239|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0174||95.0|||||t-test, 2 sided|||Global Executive Composite||||0.0174
72567797|NCT00922272|144667239|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0461||95.0|||||t-test, 2 sided|||Behavioral Recognition Index||||0.0461
72486351|NCT01495858|144500955|SUPERIORITY_OR_OTHER|||||||0.0387|||||||Cochran-Mantel-Haenszel|||||||0.0387
72486352|NCT01495858|144500956|SUPERIORITY_OR_OTHER|||||||0.0305|||||||Cochran-Mantel-Haenszel|||||||0.0305
72486353|NCT01495858|144500957|SUPERIORITY_OR_OTHER|||||||0.0176|||||||Cochran-Mantel-Haenszel|||||||0.0176
72486354|NCT01495858|144500958|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
72486355|NCT01495858|144500959|SUPERIORITY_OR_OTHER|||||||0.0036|||||||Cochran-Mantel-Haenszel|||||||0.0036
72486356|NCT01495858|144500960|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
72486357|NCT01495858|144500961|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Cochran-Mantel-Haenszel|||||||>0.05
72486358|NCT01495858|144500962|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Cochran-Mantel-Haenszel|||||||>0.05
72486359|NCT01495858|144500963|SUPERIORITY_OR_OTHER|||||||0.4519|||||||ANCOVA|||||||0.4519
72486360|NCT01495858|144500964|SUPERIORITY_OR_OTHER|||||||0.3707|||||||ANCOVA|||||||0.3707
72486361|NCT01495858|144500965|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Log Rank|||||||>0.05
72486362|NCT01495858|144500967|SUPERIORITY_OR_OTHER|||||||0.3765|||||||Cochran-Mantel-Haenszel|||||||0.3765
72486363|NCT01576172|144500973|SUPERIORITY|||||||0.27|||||||Chi-squared|||||||0.27
72486364|NCT01576172|144500974|SUPERIORITY|||||||0.7|||||||t-test, 2 sided|t=-0.39 on 112.7 degrees of freedom (Satterthwaite)||||||0.70
72486365|NCT01576172|144500975|SUPERIORITY|||||||0.51|||||||Chi-squared|||||||0.51
72486366|NCT01576172|144500976|SUPERIORITY|||||||0.99|||||||Log Rank|||||||0.99
72486367|NCT01576172|144500977|SUPERIORITY|||||||0.62|||||||Fisher Exact|||||||0.62
72486368|NCT00303979|144500979|SUPERIORITY_OR_OTHER||Relative Improvement (%)|8.4|||<|0.001|TWO_SIDED|95.0|7.0|9.7|||a large sample test (z-test)|||Performance Measure #1: relative change in % of eligible patients treated with angiotensin converting enzyme inhibitor and/or angiotensin II receptor blockers (ACEU/ARB).||9.7|7.0|<0.001
72486369|NCT00303979|144500979|SUPERIORITY_OR_OTHER||Relative improvement (%)|8.6|||<|0.001|TWO_SIDED|95.0|7.7|9.6|||a large sample test (z-test)|||Performance Measure #2: relative change in % of eligible patients treated with beta-blockers.||9.6|7.7|<0.001
72567798|NCT00922272|144667239|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0146||95.0|||||t-test, 2 sided|||Metacognition Index||||0.0146
72567799|NCT00922272|144667240|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.5||||0.7418|TWO_SIDED|95.0|-3.8|2.7|||ANCOVA|||Global Executive Composite||2.7|-3.8|0.7418
72567800|NCT00922272|144667240|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.8||||0.6429|TWO_SIDED|95.0|-2.6|4.1|||ANCOVA|||Behavioral Recognition Index||4.1|-2.6|0.6429
72567801|NCT00922272|144667240|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.4||||0.4364|TWO_SIDED|95.0|-4.8|2.1|||ANCOVA|||Metacognition Index||2.1|-4.8|0.4364
72567802|NCT02588950|144667251|SUPERIORITY||Geometric LSMean Ratio|1.46|||||TWO_SIDED|90.0|1.08|1.97|||Mixed Models Analysis|||||1.97|1.08|
72567803|NCT02588950|144667255|SUPERIORITY||Geometric LSMean Ratio|0.885|||||TWO_SIDED|90.0|0.761|1.03|||Mixed Models Analysis|||||1.03|0.761|
72513394|NCT00807846|144556885|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.061||||0.392|TWO_SIDED|95.0|-0.202|0.079|||Chi-squared||Mean Difference (Final Values) indicates difference in incidence (proportion) between treatments.|The number of subjects with at least a 30% improvement in Parent/Guardian's Global Assessment of Overall Well-Being was compared between the two treatment groups using a chi-square test. A 95% CI for the difference in incidence between groups was also computed.||0.079|-0.202|0.392
72513395|NCT00807846|144556886|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.402||||0.897|TWO_SIDED|95.0|-6.5|5.69|||ANCOVA|||Change from Baseline to Week 6 was analyzed using ANCOVA model as well with treatment and Baseline value as a covariate. The LS mean change from Baseline was compared between treatment groups and an appropriate p-value and 95% CI for the difference between the two treatment groups was generated. This analysis was conducted using a two-sided test with α=0.05.||5.69|-6.50|0.897
72513396|NCT00807846|144556887|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.102||||0.2|TWO_SIDED|95.0|-0.257|0.053|||Chi-squared||Mean Difference (Final Values) indicates difference in incidence (proportion) between treatments.|The number of participants with at least a 30% improvement in participant's Global Assessment of Overall Well-Being was compared between the two treatment groups using a chi-square test. A 95% CI for the difference in incidence between groups was also computed.||0.053|-0.257|0.200
72513397|NCT02491073|144556911|OTHER||geometric mean ratio|1.05||||1.05|TWO_SIDED|90.0|0.98|1.09|||geometric mean ration||The parameter dispersion type:Geometric coefficient of variation Dispersion Value: FT4: 0.220|There is no hypothesis testing in this study. The sample size was determined outside of statistical considerations; it was required by the U.S. Food and Drug Administration (FDA) in the New Drug Application 022416 Approval Letter issued on 08 November 2013 for PMR 2099-9.|In each geometric mean ratio estimate, free thyroid hormone levels as measured by the automated kit assay represent the numerator; free thyroid hormone levels as measured by the optimized equilibrium dialysis method represent the denominator.|1.09|0.98|1.05
72513398|NCT02491073|144556911|OTHER||Geometric Mean Ratio|1.15|||||TWO_SIDED|90.0|1.09|1.22|||Geometric Mean Ratio||parameter dispersion type: Geometric Coefficient of Variation Dispersion Value : FT3: 0.178|There is no hypothesis testing in this study. The sample size was determined outside of statistical considerations; it was required by the U.S. Food and Drug Administration (FDA) in the New Drug Application 022416 Approval Letter issued on 08 November 2013 for PMR 2099-9.|In each geometric mean ratio estimate, free thyroid hormone levels as measured by the automated kit assay represent the numerator; free thyroid hormone levels as measured by the optimized equilibrium dialysis method represent the denominator.|1.22|1.09|
72513399|NCT02491073|144556912|OTHER|There is no hypothesis testing in this study. The sample size was determined outside of statistical considerations; it was required by the U.S. Food and Drug Administration (FDA) in the New Drug Application 022416 Approval Letter issued on 08 November 2013 for PMR 2099-9.|Geometric Mean Ratio|1.01|||||TWO_SIDED|90.0|1.01|1.03|||||Parameter dispersion type: geometric coefficient of variation dispersion value 0.024|FT4|In each geometric mean ratio estimate, free thyroid hormone levels in the spiked serum samples (LS or MS or HS) represent the numerator; free thyroid hormone levels in non-spiked serum samples (NS) represent the denominator|1.03|1.01|
72513400|NCT02491073|144556912|OTHER|There is no hypothesis testing in this study. The sample size was determined outside of statistical considerations; it was required by the U.S. Food and Drug Administration (FDA) in the New Drug Application 022416 Approval Letter issued on 08 November 2013 for PMR 2099-9.|Geometric Mean Ratio|1.03|||||TWO_SIDED|90.0|1.03|1.04|||||parameter dispersion value - geometric coefficient of variation dispersion value - 0.020|FT4|In each geometric mean ratio estimate, free thyroid hormone levels in the spiked serum samples (LS or MS or HS) represent the numerator; free thyroid hormone levels in non-spiked serum samples (NS) represent the denominator|1.04|1.03|
72513401|NCT02491073|144556912|OTHER|There is no hypothesis testing in this study. The sample size was determined outside of statistical considerations; it was required by the U.S. Food and Drug Administration (FDA) in the New Drug Application 022416 Approval Letter issued on 08 November 2013 for PMR 2099-9.|geometric mean ratio|1.05|||||TWO_SIDED|90.0|1.05|1.06|||||parameter dispersion type - geometric coefficient variation dispersion value - 0.021|FT4|In each geometric mean ratio estimate, free thyroid hormone levels in the spiked serum samples (LS or MS or HS) represent the numerator; free thyroid hormone levels in non-spiked serum samples (NS) represent the denominator|1.06|1.05|
72486370|NCT00303979|144500979|SUPERIORITY_OR_OTHER||Relative improvement (%)|79.7|||<|0.001|TWO_SIDED|95.0|70.5|89.0|||a large sample test (z-test)|||Performance Measure #3: relative change in % of eligible patients treated with aldosterone receptor antagonists.||89.0|70.5|<0.001
72486371|NCT00303979|144500979|SUPERIORITY_OR_OTHER||Relative Improvement (%)|1.0||||0.546|TWO_SIDED|95.0|-2.2|4.2|||a large sample test (z-test)|||Performance Measure #4: relative change in % of eligible patients treated with anticoagulation for AF.||4.2|-2.2|0.546
72513402|NCT02491073|144556912|OTHER|There is no hypothesis testing in this study. The sample size was determined outside of statistical considerations; it was required by the U.S. Food and Drug Administration (FDA) in the New Drug Application 022416 Approval Letter issued on 08 November 2013 for PMR 2099-9.|geometric mean ratio|1.0|||||TWO_SIDED|90.0|0.99|1.02|||||parameter dispersion type -geometric coefficient of variation dispersion value - 0.040|FT3|In each geometric mean ratio estimate, free thyroid hormone levels in the spiked serum samples (LS or MS or HS) represent the numerator; free thyroid hormone levels in non-spiked serum samples (NS) represent the denominator|1.02|0.99|
72567804|NCT02588950|144667256|SUPERIORITY||Median Difference (Final Values)|0.9|||||TWO_SIDED|90.0|-1.6|2.6||||||||2.60|-1.60|
72576933|NCT00261443|144680718|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.78||||0.545|TWO_SIDED|95.0|0.35|1.74||CMH General Association Test controlling for mood stabilizer.|Cochran-Mantel-Haenszel|||Week 52 (LOCF) Treatment Comparison||1.74|0.35|0.545
72486372|NCT00303979|144500979|SUPERIORITY_OR_OTHER||Relative Improvement (%)|81.9|||<|0.001|TWO_SIDED|95.0|72.2|91.7|||a large sample test (z-test)|||Performance Measure #5: relative change in % of eligible patients treated with cardiac resynchronization therapy (CRT-P/CRT-D).||91.7|72.2|<0.001
72486373|NCT00303979|144500979|SUPERIORITY_OR_OTHER||Relative Improvement (%)|62.1|||<|0.001|TWO_SIDED|95.0|59.1|65.1|||a large sample test (z-test)|||Performance Measure #6: relative change in % of eligible patients treated with implantable cardioverter-defibrillator (ICD) or CRT-D.||65.1|59.1|<0.001
72486374|NCT00303979|144500979|SUPERIORITY_OR_OTHER||Relative Improvement (%)|14.7|||<|0.001|TWO_SIDED|95.0|12.6|16.8|||a large sample test (z-test)|||Performance Measure #7: relative change in % of eligible patients with HF education.||16.8|12.6|<0.001
72567805|NCT01936519|144667262|EQUIVALENCE|Mann Whitney U Test was performed|Mean Difference (Net)|27.32|STANDARD_ERROR_OF_MEAN|20.61||0.283|TWO_SIDED|95.0|-16.17|70.8||Cockcroft-Gault Clearance|Wilcoxon (Mann-Whitney)|||Statistical analysis was performed on the Cockcroft Gault Creatinine clearance 2 year data.||70.80|-16.17|0.283
72567806|NCT01936519|144667263|EQUIVALENCE|Wilcoxon Test|Median Difference (Final Values)|34.08|STANDARD_ERROR_OF_MEAN|11.44||0.013|TWO_SIDED|95.0|9.95|58.21|||Wilcoxon (Mann-Whitney)|||Statistical analysis was performed on the MDRD Clearance 2 year data row data.||58.21|9.95|0.013
72567807|NCT01936519|144667264|EQUIVALENCE|Wilcoxon Test|Mean Difference (Final Values)|22.22|STANDARD_ERROR_OF_MEAN|12.09||0.099|TWO_SIDED|95.0|-3.28|47.72|||Wilcoxon (Mann-Whitney)|||Statistical analysis was performed on the Iothalamate Clearance 2 year data.||47.72|-3.28|0.099
72567808|NCT01936519|144667264|EQUIVALENCE|Non-parametric statistical tests were used for all analyses, including the Mann-Whitney U test for continuous outcomes and Pearson's chi-square test for binary outcomes. Univariate statistical tests were used for all comparisons. Cohen's d was utilized for all comparisons to provide information about effect size.|Mean Difference (Final Values)|29.08|STANDARD_ERROR_OF_MEAN|13.29||0.032|TWO_SIDED|95.0|1.04|57.1|||Wilcoxon (Mann-Whitney)|||"Power and sample size. The assumption was made that eGFR would improve from 34 mL/min/1.73 m2 to 43 mL/min/1.73 m2. It was determined that a sample size of 12 in each group would have 80% power to detect a difference in means of -9.0 (the difference between a group 1 mean of 34.0 and a group 2 mean of 43.0) assuming that the common standard deviation was 7.5 using a two group t-test with a 0.05 two-sided significance level.~Data from the 2 year time point was used for analysis."||57.1|1.04|.032
72567809|NCT01936519|144667264|EQUIVALENCE|Difference of zero hypothesized.|Mean Difference (Final Values)|-0.56|STANDARD_ERROR_OF_MEAN|0.263||0.015|TWO_SIDED|95.0|-1.11|-0.003|||Wilcoxon (Mann-Whitney)|||Statistical analysis was performed on 2 year data time point.||-0.003|-1.11|0.015
72567810|NCT04397445|144667279|SUPERIORITY|||||||0.54||||||A 1-sided lower P value \<.05 was considered significant for ranitidine vs. placebo as the aim was to evaluate if ranitidine increased NDMA exposure. Comparisons were performed separately with each diet without adjustment for multiplicity.|Wilcoxon (Mann-Whitney)|||A Wilcoxon signed-rank test was used for analyses, per the statistical analysis plan, as NDMA urine data were not normally distributed|The median of the paired differences (interquartile range) between ranitidine and placebo is 0 (-6.9 to 0) ng. The median of the paired differences is calculated by first determining the difference between the two treatments for each individual participant and then determining the median of those values. The Wilcoxon signed-rank test that was used for NDMA analyses is also based on first determining the difference between the treatment groups for each individual participant.|||0.54
72567811|NCT04397445|144667279|SUPERIORITY|||||||0.71||||||A 1-sided lower P value \<.05 was considered significant for ranitidine vs. placebo as the aim was to evaluate if ranitidine increased NDMA exposure. Comparisons were performed separately with each diet without adjustment for multiplicity.|Wilcoxon (Mann-Whitney)|||A Wilcoxon signed-rank test was used for analyses, per the statistical analysis plan, as NDMA urine data were not normally distributed|The median of the paired differences (interquartile range) between ranitidine and placebo is -1.1 (-9.1 to 11.5) ng. The median of the paired differences is calculated by first determining the difference between the two treatments for each individual participant and then determining the median of those values. The Wilcoxon signed-rank test that was used for NDMA analyses is also based on first determining the difference between the treatment groups for each individual participant.|||0.71
72567812|NCT04397445|144667280|SUPERIORITY|||||||0.005||||||Exploratory analyses on the effect of diet used a 1-sided lower P value \<.05 for NDMA as the cured-meats diet was designed to have higher NDMA.|Wilcoxon (Mann-Whitney)|||A Wilcoxon signed-rank test was used for analyses, per the statistical analysis plan, as NDMA urine data were not normally distributed|The median of the paired differences (interquartile range) between the cured-meats diet and noncured-meats diet is 9.3 (3.8 to 25.0) ng. The median of the paired differences is calculated by first determining the difference between the two treatments for each individual participant and then determining the median of those values. The Wilcoxon signed-rank test that was used for NDMA analyses is also based on first determining the difference between the treatment groups for each individual participant.|||0.005
72567813|NCT04397445|144667280|SUPERIORITY|||||||0.007||||||Exploratory analyses on the effect of diet used a 1-sided lower P value \<.05 for NDMA as the cured-meats diet was designed to have higher NDMA|Wilcoxon (Mann-Whitney)|||A Wilcoxon signed-rank test was used for analyses, per the statistical analysis plan, as NDMA urine data were not normally distributed|The median of the paired differences (interquartile range) between the cured-meats diet and noncured-meats diet is 6.4 (0 to 23.4) ng. The median of the paired differences is calculated by first determining the difference between the two treatments for each individual participant and then determining the median of those values. The Wilcoxon signed-rank test that was used for NDMA analyses is also based on first determining the difference between the treatment groups for each individual participant.|||0.007
72567814|NCT04397445|144667281|OTHER||Geometric Mean Ratio|0.94||||0.92|TWO_SIDED|90.0|0.87|1.01||A 1-sided lower P value \<.05 was considered significant for the exploratory analyses of ranitidine vs. placebo because the study aim was to evaluate if ranitidine increased DMA exposure.|Mixed Models Analysis||This compares the results from ranitidine (numerator) with placebo (denominator).|As DMA data were log-normally distributed, analyses were based on a mixed-effect analysis of geometric means with terms for treatment, period, and sequence||1.01|0.87|0.92
72567815|NCT04397445|144667281|OTHER||Geometric Mean Ratio|0.95||||0.74|TWO_SIDED|90.0|0.81|1.1||A 1-sided lower P value \<.05 was considered significant for the exploratory analyses of ranitidine vs. placebo because the study aim was to evaluate if ranitidine increased DMA exposure.|Mixed Models Analysis||This compares the results from ranitidine (numerator) with placebo (denominator).|As DMA data were log-normally distributed, analyses were based on a mixed-effect analysis of geometric means with terms for treatment, period, and sequence||1.10|0.81|0.74
72567816|NCT04397445|144667281|OTHER||Geometric Mean Ratio|1.05||||0.52|TWO_SIDED|95.0|0.9|1.23||A 2-sided P value \<.05 was used for DMA as the diet was not expected to affect these outcomes|Mixed Models Analysis||This compares the results from the cured-meats diet (numerator) with the noncured-meats diet (denominator)|As DMA data were log-normally distributed, analyses were based on a mixed-effect analysis of geometric means with terms for treatment, period, and sequence.||1.23|0.90|0.52
72624120|NCT01892189|144778533|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2037|STANDARD_ERROR_OF_MEAN|0.1917||0.295|TWO_SIDED|95.0|-0.5933|0.1859|||ANOVA||Difference between least square means of TAK-063 10 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Right Amygdala: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.1859|-0.5933|0.295
72624121|NCT01892189|144778533|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.0602|STANDARD_ERROR_OF_MEAN|0.18209||0.743|TWO_SIDED|95.0|-0.4303|0.3098|||ANOVA||Difference between least square means of TAK-063 30 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Right Amygdala: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.3098|-0.4303|0.743
72624122|NCT01892189|144778533|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1774|STANDARD_ERROR_OF_MEAN|0.16068||0.277||95.0|-0.504|0.1491|||ANOVA||Difference between least square means of TAK-063 3 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Left Substantia Nigra: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.1491|-0.5040|0.277
72486375|NCT00303979|144500981|SUPERIORITY_OR_OTHER||Mean Relative Change (%)|19.4||||0.004|TWO_SIDED|95.0|-1.1|39.8|||t-test, 2 sided|||Performance Measure #1: Relative change at 24 months compared with baseline in ACEI/ARB for the aggregate practices.||39.8|-1.1|0.004
72486376|NCT00303979|144500981|SUPERIORITY_OR_OTHER||Mean Relative Change (%)|7.6|||<|0.001|TWO_SIDED|95.0|5.1|10.2|||t-test, 2 sided|||Performance Measure #2: the relative change at 24 months compared with baseline in beta-blockers for the aggregate practices.||10.2|5.1|<0.001
72486377|NCT00303979|144500981|SUPERIORITY_OR_OTHER||Mean Relative Change (%)|30.0|||<|0.001|TWO_SIDED|95.0|24.6|35.5|||t-test, 2 sided|||Performance Measure #3: the relative change at 24 months compared with baseline in aldosterone antagonist for the aggregate practices.||35.5|24.6|<0.001
72486378|NCT00303979|144500981|SUPERIORITY_OR_OTHER||Mean Relative Change (%)|1.0||||0.513||95.0|-3.6|5.5|||t-test, 2 sided|||Performance Measure #4: the relative change at 24 months compared with baseline in anticoagulation for AF for the aggregate practices.||5.5|-3.6|0.513
72486379|NCT00303979|144500981|SUPERIORITY_OR_OTHER||Mean Relative Change (%)|48.4|||<|0.001|TWO_SIDED|95.0|37.9|58.8|||t-test, 2 sided|||Performance Measure #5: the relative change at 24 months compared with baseline in CRT-P/CRT-D for the aggregate practices.||58.8|37.9|<0.001
72486380|NCT00303979|144500981|SUPERIORITY_OR_OTHER||Mean Relative Change (%)|70.9|||<|0.001|TWO_SIDED|95.0|61.0|80.8|||t-test, 2 sided|||Performance Measure #6: the relative change at 24 months compared with baseline in ICD/CRT-D for the aggregate practices.||80.8|61.0|<0.001
72486381|NCT00303979|144500981|SUPERIORITY_OR_OTHER||Mean Relative Change (%)|50.6|||<|0.001|TWO_SIDED|95.0|27.1|74.2|||t-test, 2 sided|||Performance Measure #7: the relative change at 24 months compared with baseline in HF education for the aggregate practices.||74.2|27.1|<0.001
72486382|NCT00303979|144500981|SUPERIORITY_OR_OTHER||Mean Relative Change (%)|19.2|||<|0.001|TWO_SIDED|95.0|16.3|22.0|||t-test, 2 sided|||Composite Score: The relative change at 24 months compared with baseline in composite score for the aggregate practices.||22.0|16.3|<0.001
72486383|NCT00303979|144500982|SUPERIORITY_OR_OTHER||Mean Relative Change (%)|10.3||||0.197|TWO_SIDED|95.0|-5.4|25.9|||t-test, 2 sided|||Performance Measure #1: the relative change of Cohort B (6 months) compared with Cohort A at baseline in ACEI/ARB for the aggregate practices.||25.9|-5.4|0.197
72486384|NCT00303979|144500982|SUPERIORITY_OR_OTHER||Mean Relative Change (%)|10.6||||0.061|TWO_SIDED|95.0|-0.5|21.7|||t-test, 2 sided|||Performance Measure #2: the relative change of Cohort B (6 months) compared with Cohort A at baseline in beta-blockers for the aggregate practices.||21.7|-0.5|0.061
72486385|NCT00303979|144500982|SUPERIORITY_OR_OTHER||Mean Relative Change (%)|-1.1||||0.622|TWO_SIDED|95.0|-5.7|3.4|||t-test, 2 sided|||Performance Measure #3: the relative change of Cohort B (6 months) compared with Cohort A at baseline in aldosterone antagonist for the aggregate practices.||3.4|-5.7|0.622
72486386|NCT00303979|144500982|SUPERIORITY_OR_OTHER||Mean Relative Change (%)|6.2||||0.05|TWO_SIDED|95.0|0.0|12.4|||t-test, 2 sided|||Performance Measure #4: the relative change of Cohort B (6 months) compared with Cohort A at baseline in anticoagulation for AF for the aggregate practices.||12.4|0.0|0.05
72486387|NCT00303979|144500982|SUPERIORITY_OR_OTHER||Mean Relative Change (%)|-1.8||||0.711|TWO_SIDED|95.0|-11.2|7.7|||t-test, 2 sided|||Performance Measure #5: the relative change of Cohort B (6 months) compared with Cohort A at baseline in CRT-P/CRT-D for the aggregate practices.||7.7|-11.2|0.711
72486388|NCT00303979|144500982|SUPERIORITY_OR_OTHER||Mean Relative Change (%)|14.4|||<|0.001|TWO_SIDED|95.0|6.9|22.0|||t-test, 2 sided|||Performance Measure #6: the relative change of Cohort B (6 months) compared with Cohort A at baseline in ICD/CRT-D for the aggregate practices.||22.0|6.9|<0.001
72486389|NCT00303979|144500982|SUPERIORITY_OR_OTHER||Mean Relative Change (%)|38.5|||<|0.001|TWO_SIDED|95.0|23.2|53.8|||t-test, 2 sided|||Performance Measure #7: the relative change of Cohort B (6 months) compared with Cohort A at baseline in HF education for the aggregate practices.||53.8|23.2|<0.001
72486390|NCT00303979|144500982|SUPERIORITY_OR_OTHER||Mean Relative Change (%)|6.6|||<|0.001|TWO_SIDED|95.0|4.2|9.0|||t-test, 2 sided|||Composite Score: the relative change of Cohort B (6 months) compared with Cohort A at baseline in composite score for the aggregate practices.||9.0|4.2|<0.001
72486391|NCT00303979|144500983|SUPERIORITY_OR_OTHER||Mean Relative Change (%)|10.5||||0.19|TWO_SIDED|95.0|-5.3|26.3|||t-test, 2 sided|||Performance Measure #1: the relative change of Cohort C (18 months) compared with Cohort A at baseline in ACEI/ARB for the aggregate practices.||26.3|-5.3|0.190
72486392|NCT00303979|144500983|SUPERIORITY_OR_OTHER||Mean Relative Change (%)|14.3||||0.048|TWO_SIDED|95.0|0.1|28.4|||t-test, 2 sided|||Performance Measure #2: the relative change of Cohort C (18 months) compared with Cohort A at baseline in beta-blockers for the aggregate practices.||28.4|0.1|0.048
72567817|NCT04397445|144667281|OTHER||Geometric Mean Ratio|1.05||||0.42|TWO_SIDED|95.0|0.93|1.19||A 2-sided P value \<.05 was used for DMA as the diet was not expected to affect these outcomes|Mixed Models Analysis||This compares the results from the cured-meats diet (numerator) with the noncured-meats diet (denominator)|As DMA data were log-normally distributed, analyses were based on a mixed-effect analysis of geometric means with terms for treatment, period, and sequence.||1.19|0.93|0.42
72567818|NCT04397445|144667282|OTHER||Geometric Mean Ratio|0.81||||0.001|TWO_SIDED|95.0|0.72|0.91||Exploratory analyses on the effect of diet used a 2-sided P value \<.05 for ranitidine as the diet was not expected to affect these outcomes|Mixed Models Analysis|||As ranitidine data were log-normally distributed, analyses were based on a mixed-effect analysis of geometric means with terms for treatment, period, and sequence|This compares the results from the cured-meats diet (numerator) with the noncured-meats diet (denominator)|0.91|0.72|0.001
72567819|NCT04397445|144667284|OTHER||Geometric Mean Ratio|1.0||||0.46|TWO_SIDED|90.0|0.91|1.11||A 1-sided lower P value \<.05 was considered significant for the exploratory analyses of ranitidine vs. placebo because the study aim was to evaluate if ranitidine increased DMA exposure.|Mixed Models Analysis||This compares the results from ranitidine (numerator) with placebo (denominator)|As DMA data were log-normally distributed, analyses were based on a mixed-effect analysis of geometric means with terms for treatment, period, and sequence||1.11|0.91|0.46
72567820|NCT04397445|144667284|OTHER||Geometric Mean Ratio|1.0||||0.49|TWO_SIDED|90.0|0.8|1.25||A 1-sided lower P value \<.05 was considered significant for the exploratory analyses of ranitidine vs. placebo because the study aim was to evaluate if ranitidine increased DMA exposure.|Mixed Models Analysis|||As DMA data were log-normally distributed, analyses were based on a mixed-effect analysis of geometric means with terms for treatment, period, and sequence|This compares the results from ranitidine (numerator) with placebo (denominator)|1.25|0.80|0.49
72567821|NCT04397445|144667284|OTHER||Geometric Mean Ratio|0.8||||0.02|TWO_SIDED|95.0|0.67|0.95||A 2-sided P value \<.05 was used for DMA as the diet was not expected to affect these outcomes|Mixed Models Analysis||This compares the results from the cured-meats diet (numerator) with the noncured-meats diet (denominator)|As DMA data were log-normally distributed, analyses were based on a mixed-effect analysis of geometric means with terms for treatment, period, and sequence.||0.95|0.67|0.02
72567822|NCT04397445|144667284|OTHER||Geometric Mean Ratio|0.8||||0.03|TWO_SIDED|95.0|0.65|0.98||A 2-sided P value \<.05 was used for DMA as the diet was not expected to affect these outcomes|Mixed Models Analysis|||As DMA data were log-normally distributed, analyses were based on a mixed-effect analysis of geometric means with terms for treatment, period, and sequence|This compares the results from the cured-meats diet (numerator) with the noncured-meats diet (denominator)|0.98|0.65|0.03
72567823|NCT04397445|144667285|OTHER||Geometric Mean Ratio|0.77||||0.002|TWO_SIDED|95.0|0.66|0.89||Exploratory analyses on the effect of diet used a 2-sided P value \<.05 for ranitidine as the diet was not expected to affect these outcomes|Mixed Models Analysis||This compares the results from the cured-meats diet (numerator) with the noncured-meats diet (denominator).|As ranitidine data were log-normally distributed, analyses were based on a mixed-effect analysis of geometric means with terms for treatment, period, and sequence||0.89|0.66|0.002
72567824|NCT01338649|144667296|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0211|||||||t-test, 2 sided|t-test on two groups of differences||||||0.0211
72567825|NCT00361335|144667313|SUPERIORITY_OR_OTHER|||||||0.051||95.0|||||2-sided Cochran-Mantel-Haenszel|||Hypothesis: Null hypothesis: No difference in ACR 50 response at Wk 14 comparing Groups V vs VI at 0.05 level of significance. Sample size: The sample size of 125 patients in each of the 5 randomized groups will provide at least 90 percentage power to detect a difference in the ACR 50 response rates between groups assuming 13 percentage response in Group V and \~29-31 percentage response in the Group VI at α = 0.05.||||0.051
72567826|NCT00361335|144667313|SUPERIORITY_OR_OTHER|||||||0.073||95.0|||||2-sided Cochran-Mantel-Haenszel|||Hypothesis: Null hypothesis: No difference in ACR 50 response at Wk 14 comparing Groups I vs V at 0.05 level of significance. Sample size: The sample size of 125 patients in each of the 5 randomized groups will provide at least 90 percentage power to detect a difference in the ACR 50 response rates between groups assuming 13 percentage response in Group V and \~29-31% response in the Group I at α = 0.05.||||0.073
72624123|NCT01892189|144778533|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.0539|STANDARD_ERROR_OF_MEAN|0.17338||0.758|TWO_SIDED|95.0|-0.4062|0.2985|||ANOVA||Difference between least square means of TAK-063 10 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Left Substantia Nigra: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.2985|-0.4062|0.758
72624124|NCT01892189|144778533|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4377|STANDARD_ERROR_OF_MEAN|0.16468||0.012|TWO_SIDED|95.0|-0.7724|-0.1031|||ANOVA||Difference between least square means of TAK-063 30 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Left Substantia Nigra: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||-0.1031|-0.7724|0.012
72486393|NCT00303979|144500983|SUPERIORITY_OR_OTHER||Mean Relative Change (%)|5.8||||0.24|TWO_SIDED|95.0|-3.9|15.4|||t-test, 2 sided|||Performance Measure #3: the relative change of Cohort C (18 months) compared with Cohort A at baseline in aldosterone antagonist for the aggregate practices.||15.4|-3.9|0.240
72567827|NCT00361335|144667313|SUPERIORITY_OR_OTHER|||||||0.093||95.0|||||2-sided Cochran-Mantel-Haenszel|||Hypothesis: Null hypothesis: No difference in ACR 50 response at Wk 14 comparing Groups III vs V at 0.05 level of significance. Sample size: The sample size of 125 patients in each of the 5 randomized groups will provide at least 90 percentage power to detect a difference in the ACR 50 response rates between groups assuming 13 percentage response in Group V and \~29-31 percentage response in the Group III at α = 0.05.||||0.093
72567828|NCT00361335|144667313|SUPERIORITY_OR_OTHER|||||||0.465||95.0|||||2-sided Cochran-Mantel-Haenszel|||Hypothesis: Null hypothesis: No difference in ACR 50 response at Wk 14 comparing Groups VII vs V at 0.05 level of significance. Sample size: The sample size of 125 patients in each of the 5 randomized groups will provide at least 90 percentage power to detect a difference in the ACR 50 response rates between groups assuming 13 percentage response in Group V and \~29-31 percentage response in the Group VII at α = 0.05.||||0.465
72624125|NCT01892189|144778533|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1037|STANDARD_ERROR_OF_MEAN|0.14849||0.49|TWO_SIDED|95.0|-0.4055|0.1981|||ANOVA||Difference between least square means of TAK-063 3 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Right Substantia Nigra: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.1981|-0.4055|0.490
72486394|NCT00303979|144500983|SUPERIORITY_OR_OTHER||Mean Relative Change (%)|6.7||||0.033|TWO_SIDED|95.0|0.5|13.0|||t-test, 2 sided|||Performance Measure #4: the relative change of Cohort C (18 months) compared with Cohort A at baseline in anticoagulation for AF for the aggregate practices.||13.0|0.5|0.033
72486395|NCT00303979|144500983|SUPERIORITY_OR_OTHER||Mean Relative Change (%)|9.3||||0.085|TWO_SIDED|95.0|-1.3|19.8|||t-test, 2 sided|||Performance Measure #5: the relative change of Cohort C (18 months) compared with Cohort A at baseline in CRT-P/CRT-D for the aggregate practices.||19.8|-1.3|0.085
72486396|NCT00303979|144500983|SUPERIORITY_OR_OTHER||Mean Relative Change (%)|17.6|||<|0.001|TWO_SIDED|95.0|9.3|25.8|||t-test, 2 sided|||Performance Measure #6: the relative change of Cohort C (18 months) compared with Cohort A at baseline in ICD/CRT-D for the aggregate practices.||25.8|9.3|<0.001
72486397|NCT00303979|144500983|SUPERIORITY_OR_OTHER||Mean Relative Change (%)|59.5|||<|0.001|TWO_SIDED|95.0|33.9|85.2|||t-test, 2 sided|||Performance Measure #7: the relative change of Cohort C (18 months) compared with Cohort A at baseline in HF education for the aggregate practices.||85.2|33.9|<0.001
72486398|NCT00303979|144500983|SUPERIORITY_OR_OTHER||Mean Relative Change (%)|10.6|||<|0.001|TWO_SIDED|95.0|7.6|13.6|||t-test, 2 sided|||Composite Score: the relative change of Cohort C (18 months) compared with Cohort A at baseline in composite score for the aggregate practices.||13.6|7.6|<0.001
72486399|NCT05417607|144500996|SUPERIORITY||Mean Difference (Net)|3.75|STANDARD_DEVIATION|5.86||0.0047|TWO_SIDED|95.0|1.27|6.22|||t-test, 2 sided|||Within group pre- and post-intervention.||6.22|1.27|0.0047
72486400|NCT05417607|144500997|SUPERIORITY||Mean Difference (Net)|2.21|STANDARD_DEVIATION|7.9||0.2383|TWO_SIDED|95.0|-1.6|6.02|||t-test, 2 sided|||Within group pre- and post-intervention.||6.02|-1.6|0.2383
72486401|NCT05417607|144500998|SUPERIORITY||Mean Difference (Net)|-0.71|STANDARD_DEVIATION|3.58||0.3426|TWO_SIDED|95.0|-2.22|0.8|||t-test, 2 sided|||Within group pre- and post-intervention.||0.80|-2.22|0.3426
72486402|NCT01289821|144501051|SUPERIORITY_OR_OTHER||Percentage of Participants|43.9||||0.36|TWO_SIDED|80.0|33.19|55.09|||One-sample exact binomial test|||"Null hypothesis: True probability p of objective tumor response does not exceed p0, p0=0.4. H0: p\<=0.4 One-sided type I error probability of alpha=10%"||55.09|33.19|0.36
72486403|NCT03591354|144501057|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
72486404|NCT02901574|144501134|SUPERIORITY||Mean Difference (Final Values)|3.87||||0.24|TWO_SIDED|95.0|-2.55|10.3||Threshold for significance is two-sided alpha of 0.05.|Mixed Models Analysis|||||10.30|-2.55|0.24
72486405|NCT01010633|144501146|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.3|||<|0.001|TWO_SIDED|95.0|5.7|22.9|||Chi-squared|||||22.9|5.7|<0.001
72486406|NCT01010633|144501148|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|31.0|||<|0.001|TWO_SIDED|95.0|21.4|40.7|||Chi-squared|||||40.7|21.4|<0.001
72486407|NCT02790138|144501149|SUPERIORITY||Percentage Difference|21.6||||0.013|TWO_SIDED|95.0|4.9|37.5||The significance level was 0.05.|Fisher's Exact Test|||The Placebo IV and Vedolizumab IV 300 mg groups were analyzed using Fisher's Exact Test at Week 14.||37.5|4.9|0.013
72486408|NCT02790138|144501150|SUPERIORITY||Percentage Difference|17.6|||=|0.043|TWO_SIDED|95.0|0.3|35.1||No multiplicity adjustment for inferential testing for secondary endpoints was preplanned, p-values from these tests are presented as nominal p-values. The significance level was 0.05.|Chi-squared Test|||||35.1|0.3|=0.043
72486409|NCT02790138|144501151|SUPERIORITY||Percentage Difference|25.5|||=|0.004|TWO_SIDED|95.0|8.0|41.4||No multiplicity adjustment for inferential testing for secondary endpoints was preplanned, p-values from these tests are presented as nominal p-values. The significance level was 0.05.|Fisher's Exact Test|||Week 14||41.4|8.0|=0.004
72486410|NCT02790138|144501151|SUPERIORITY||Percentage Difference|19.6|||=|0.027|TWO_SIDED|95.0|1.9|37.0||No multiplicity adjustment for inferential testing for secondary endpoints was preplanned, p-values from these tests are presented as nominal p-values. The significance level was 0.05.|Chi-squared Test|||Week 34.||37.0|1.9|=0.027
72486411|NCT02790138|144501152|SUPERIORITY||Hazard Ratio (HR)|3.95|||||TWO_SIDED|95.0|1.7|9.4|||||Hazard ratio for achieving PDAI remission.|||9.4|1.7|
72486412|NCT02790138|144501153|SUPERIORITY||Percentage Difference|29.4|||=|0.003|TWO_SIDED|95.0|8.0|47.6||No multiplicity adjustment for inferential testing for secondary endpoints was preplanned, p-values from these tests are presented as nominal p-values. The significance level was 0.05.|Chi-squared Test|||Week 14||47.6|8.0|=0.003
72486413|NCT02790138|144501153|SUPERIORITY||Percentage Difference|21.6|||=|0.026|TWO_SIDED|95.0|1.9|39.8||No multiplicity adjustment for inferential testing for secondary endpoints was preplanned, p-values from these tests are presented as nominal p-values. The significance level was 0.05.|Chi-squared Test|||Week 34||39.8|1.9|=0.026
72486414|NCT02790138|144501154|SUPERIORITY||Odds Estimator|2.02|||=|0.002|TWO_SIDED|95.0|1.11|2.93||No multiplicity adjustment for inferential testing for secondary endpoints was preplanned, p-values from these tests are presented as nominal p-values. The significance level was 0.05.|Wilcoxon (Mann-Whitney)|P-value is from Wilcoxon Rank-sum Test comparing change from Baseline to relevant visits.Wilcoxon-Mann-Whitney odds estimator,95% CI are presented.||Change from Baseline at Week 14||2.93|1.11|=0.002
72486415|NCT02790138|144501154|SUPERIORITY||Odds Estimator|1.71|||=|0.02|TWO_SIDED|95.0|0.92|2.49||No multiplicity adjustment for inferential testing for secondary endpoints was preplanned, p-values from these tests are presented as nominal p-values. The significance level was 0.05.|Wilcoxon (Mann-Whitney)|P-value is from Wilcoxon Rank-sum Test comparing change from Baseline to relevant visits.Wilcoxon-Mann-Whitney odds estimator,95% CI are presented.||Change from Baseline at Week 34||2.49|0.92|=0.020
72486416|NCT02790138|144501155|SUPERIORITY||Odds Estimator|1.34|||=|0.191|TWO_SIDED|95.0|0.74|1.94||No multiplicity adjustment for inferential testing for secondary endpoints was preplanned, p-values from these tests are presented as nominal p-values. The significance level was 0.05.|Wilcoxon (Mann-Whitney)|P-value is from Wilcoxon Rank-sum Test comparing change from Baseline to relevant visits.Wilcoxon-Mann-Whitney odds estimator,95% CI are presented.||Change from Baseline at Week 14||1.94|0.74|=0.191
72567829|NCT00361335|144667313|SUPERIORITY_OR_OTHER|||||||0.872||95.0|||||2-sided Cochran-Mantel-Haenszel|||Hypothesis: Null hypothesis: No difference in ACR 50 response at Wk 14 comparing Groups II vs V at 0.05 level of significance. Sample size: The sample size of 125 patients in each of the 5 randomized groups will provide at least 90 percentage power to detect a difference in the ACR 50 response rates between groups assuming 13 percentage response in Group V and \~29-31 percentage response in the Group II at α = 0.05.||||0.872
72567830|NCT00361335|144667313|SUPERIORITY_OR_OTHER|||||||0.175||95.0|||||2-sided Cochran-Mantel-Haenszel|||Hypothesis: Null hypothesis: No difference in ACR 50 response at Wk 14 comparing Groups V vs I, V vs III, V vs II, and V vs IV at 0.05 level of significance. Sample size: The sample size of 125 patients in each of the 5 randomized groups will provide at least 90 percentage power to detect a difference in the ACR 50 response rates between groups assuming 13 percentage response in Group V and \~29-31 percentage response in the combined group (I and III) at α = 0.05.||||0.175
72567831|NCT00361335|144667314|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||2-sided Cochran-Mantel-Haenszel|||Null hypothesis: No difference in ACR 50 response at Week 24 comparing Groups V vs VI at 0.05 level of significance.||||0.002
72567832|NCT00361335|144667314|SUPERIORITY_OR_OTHER|||||||0.032||95.0|||||2-sided Cochran-Mantel-Haenszel|||Null hypothesis: No difference in ACR 50 response at Week 24 comparing Groups I vs V at 0.05 level of significance.||||0.032
72567833|NCT00361335|144667314|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||2-sided Cochran-Mantel-Haenszel|||Null hypothesis: No difference in ACR 50 response at Week 24 comparing Groups III vs V at 0.05 level of significance.||||<0.001
72567834|NCT00361335|144667314|SUPERIORITY_OR_OTHER|||||||0.795||95.0|||||2-sided Cochran-Mantel-Haenszel|||Null hypothesis: No difference in ACR 50 response at Week 24 comparing Groups V vs VII at 0.05 level of significance.||||0.795
72567835|NCT00361335|144667314|SUPERIORITY_OR_OTHER|||||||0.844||95.0|||||2-sided Cochran-Mantel-Haenszel|||Null hypothesis: No difference in ACR 50 response at Week 24 comparing Groups II vs V at 0.05 level of significance.||||0.844
72567836|NCT00361335|144667314|SUPERIORITY_OR_OTHER|||||||0.54||95.0|||||2-sided Cochran-Mantel-Haenszel|||Null hypothesis: No difference in ACR 50 response at Week 24 comparing Groups V vs I, V vs III, V vs II, and V vs IV at 0.05 level of significance.||||0.540
72567837|NCT00361335|144667315|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||2-sided Cochran-Mantel-Haenszel|||Null hypothesis: No difference in ACR 20 response at Wk 14 comparing Groups V vs VI at 0.05 level of significance.||||<0.001
72567838|NCT00361335|144667315|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||2-sided Cochran-Mantel-Haenszel|||Null hypothesis: No difference in ACR 20 response at Wk 14 comparing Groups I vs V at 0.05 level of significance.||||<0.001
72567839|NCT00361335|144667315|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||2-sided Cochran-Mantel-Haenszel|||Null hypothesis: No difference in ACR 20 response at Wk 14 comparing Groups III vs V at 0.05 level of significance.||||<0.001
72567840|NCT00361335|144667315|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||2-sided Cochran-Mantel-Haenszel|||Null hypothesis: No difference in ACR 20 response at Wk 14 comparing Groups V vs VII at 0.05 level of significance.||||0.002
72567841|NCT00361335|144667315|SUPERIORITY_OR_OTHER|||||||0.043||95.0|||||2-sided Cochran-Mantel-Haenszel|||Null hypothesis: No difference in ACR 20 response at Wk 14 comparing Groups II vs V at 0.05 level of significance.||||0.043
72567842|NCT00361335|144667315|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||2-sided Cochran-Mantel-Haenszel|||Null hypothesis: No difference in ACR 20 response at Wk 14 comparing Groups V vs I, V vs III, V vs II, and V vs IV at 0.05 level of significance.||||<0.001
72567843|NCT00361335|144667316|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||2-sided Cochran-Mantel-Haenszel|||Hypothesis: Null hypothesis: No difference in DAS28 response using CRP at Wk 14 comparing Groups V vs VI at 0.05 level of significance.||||<0.001
72567844|NCT00361335|144667316|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||2-sided Cochran-Mantel-Haenszel|||Hypothesis: Null hypothesis: No difference in DAS28 response using CRP at Wk 14 comparing Groups I vs V at 0.05 level of significance.||||<0.001
72624126|NCT01892189|144778533|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1007|STANDARD_ERROR_OF_MEAN|0.16023||0.534|TWO_SIDED|95.0|-0.4263|0.2249|||ANOVA||Difference between least square means of TAK-063 10 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Right Substantia Nigra: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.2249|-0.4263|0.534
72567845|NCT00361335|144667316|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||2-sided Cochran-Mantel-Haenszel|||Hypothesis: Null hypothesis: No difference in DAS28 response using CRP at Wk 14 comparing Groups III vs V at 0.05 level of significance.||||<0.001
72567846|NCT00361335|144667316|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||2-sided Cochran-Mantel-Haenszel|||Hypothesis: Null hypothesis: No difference in DAS28 response using CRP at Wk 14 comparing Groups V vs VII at 0.05 level of significance.||||<0.001
72567847|NCT00361335|144667316|SUPERIORITY_OR_OTHER|||||||0.003||95.0|||||2-sided Cochran-Mantel-Haenszel|||Hypothesis: Null hypothesis: No difference in DAS28 response using CRP at Wk 14 comparing Groups II vs V at 0.05 level of significance.||||0.003
72567848|NCT00361335|144667316|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||2-sided Cochran-Mantel-Haenszel|No adjustments were made to control for multiplicity||Hypothesis: Null hypothesis: No difference in DAS28 response using CRP at Wk 14 comparing Groups V vs I, V vs III, V vs II, and V vs IV at 0.05 level of significance.||||0.001
72567849|NCT00361335|144667317|SUPERIORITY_OR_OTHER|||||||0.005||95.0|||||2-sided ANOVA on van der Waerden|||Hypothesis: Null hypothesis: No difference in change from baseline in PCS score of SF-36 at Wk 14 comparing Groups V vs VI at 0.05 level of significance.||||0.005
72567850|NCT00361335|144667317|SUPERIORITY_OR_OTHER|||||||0.014||95.0|||||2-sided ANOVA on van der Waerden|||Hypothesis: Null hypothesis: No difference in change from baseline in PCS score of SF-36 at Wk 14 comparing Groups I vs V at 0.05 level of significance.||||0.014
72567851|NCT00361335|144667317|SUPERIORITY_OR_OTHER|||||||0.014||95.0|||||2-sided ANOVA on van der Waerden|||Hypothesis: Null hypothesis: No difference in change from baseline in PCS score of SF-36 at Wk 14 comparing Groups III vs V at 0.05 level of significance.||||0.014
72567852|NCT00361335|144667317|SUPERIORITY_OR_OTHER|||||||0.996||95.0|||||2-sided ANOVA on van der Waerden|||Hypothesis: Null hypothesis: No difference in change from baseline in PCS score of SF-36 at Wk 14 comparing Groups I and VII at 0.05 level of significance.||||0.996
72486417|NCT02790138|144501155|SUPERIORITY||Odds Estimator|1.07|||=|0.766|TWO_SIDED|95.0|0.6|1.54||No multiplicity adjustment for inferential testing for secondary endpoints was preplanned, p-values from these tests are presented as nominal p-values. The significance level was 0.05.|Wilcoxon (Mann-Whitney)|P-value is from Wilcoxon Rank-sum Test comparing change from Baseline to relevant visits.Wilcoxon-Mann-Whitney odds estimator,95% CI are presented.||Change from Baseline at Week 34||1.54|0.60|=0.766
72486418|NCT02790138|144501156|SUPERIORITY||Odds Estimator|1.57|||=|0.055|TWO_SIDED|95.0|0.83|2.31||No multiplicity adjustment for inferential testing for secondary endpoints was preplanned, p-values from these tests are presented as nominal p-values. The significance level was 0.05.|Wilcoxon (Mann-Whitney)|P-value is from Wilcoxon Rank-sum Test comparing change from Baseline to relevant visits.Wilcoxon-Mann-Whitney odds estimator,95% CI are presented.||Change from Baseline at Week 14||2.31|0.83|=0.055
72486419|NCT02790138|144501156|SUPERIORITY||Odds Estimator|1.48|||=|0.095|TWO_SIDED|95.0|0.79|2.16||No multiplicity adjustment for inferential testing for secondary endpoints was preplanned, p-values from these tests are presented as nominal p-values. The significance level was 0.05.|Wilcoxon (Mann-Whitney)|P-value is from Wilcoxon Rank-sum Test comparing change from Baseline to relevant visits.Wilcoxon-Mann-Whitney odds estimator,95% CI are presented.||Change from Baseline at Week 34||2.16|0.79|=0.095
72486420|NCT02790138|144501157|SUPERIORITY||Odds Estimator|1.14|||=|0.575|TWO_SIDED|95.0|0.61|1.67||No multiplicity adjustment for inferential testing for secondary endpoints was preplanned, p-values from these tests are presented as nominal p-values. The significance level was 0.05.|Wilcoxon (Mann-Whitney)|P-value is from Wilcoxon Rank-sum Test comparing change from Baseline to relevant visits.Wilcoxon-Mann-Whitney odds estimator,95% CI are presented.||Change from Baseline at Week 14||1.67|0.61|=0.575
72486421|NCT02790138|144501157|SUPERIORITY||Odds Estimator|1.21|||=|0.403|TWO_SIDED|95.0|0.65|1.78||No multiplicity adjustment for inferential testing for secondary endpoints was preplanned, p-values from these tests are presented as nominal p-values. The significance level was 0.05.|Wilcoxon (Mann-Whitney)|P-value is from Wilcoxon Rank-sum Test comparing change from Baseline to relevant visits.Wilcoxon-Mann-Whitney odds estimator,95% CI are presented.||Change from Baseline at Week 22||1.78|0.65|=0.403
72486422|NCT02790138|144501157|SUPERIORITY||Odds Estimator|1.6|||=|0.047|TWO_SIDED|95.0|0.85|2.34||No multiplicity adjustment for inferential testing for secondary endpoints was preplanned, p-values from these tests are presented as nominal p-values. The significance level was 0.05.|Wilcoxon (Mann-Whitney)|P-value is from Wilcoxon Rank-sum Test comparing change from Baseline to relevant visits.Wilcoxon-Mann-Whitney odds estimator,95% CI are presented.||Change from Baseline at Week 34||2.34|0.85|=0.047
72486423|NCT02790138|144501158|SUPERIORITY||Odds Estimator|1.44|||=|0.119|TWO_SIDED|95.0|0.77|2.12||No multiplicity adjustment for inferential testing for secondary endpoints was preplanned, p-values from these tests are presented as nominal p-values. The significance level was 0.05.|Wilcoxon (Mann-Whitney)|P-value is from Wilcoxon Rank-sum Test comparing change from Baseline to relevant visits.Wilcoxon-Mann-Whitney odds estimator,95% CI are presented.||Change from Baseline at Week 14||2.12|0.77|=0.119
72486424|NCT02790138|144501158|SUPERIORITY||Odds Estimator|1.15|||=|0.542|TWO_SIDED|95.0|0.62|1.69||No multiplicity adjustment for inferential testing for secondary endpoints was preplanned, p-values from these tests are presented as nominal p-values. The significance level was 0.05.|Wilcoxon (Mann-Whitney)|P-value is from Wilcoxon Rank-sum Test comparing change from Baseline to relevant visits.Wilcoxon-Mann-Whitney odds estimator,95% CI are presented.||Change from Baseline at Week 22||1.69|0.62|=0.542
72486425|NCT02790138|144501158|SUPERIORITY||Odds Estimator|1.22|||=|0.404|TWO_SIDED|95.0|0.65|1.78||No multiplicity adjustment for inferential testing for secondary endpoints was preplanned, p-values from these tests are presented as nominal p-values. The significance level was 0.05.|Wilcoxon (Mann-Whitney)|P-value is from Wilcoxon Rank-sum Test comparing change from Baseline to relevant visits.Wilcoxon-Mann-Whitney odds estimator,95% CI are presented.||Change from Baseline at Week 34||1.78|0.65|=0.404
72486426|NCT01226459|144501166|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.1|||<|0.0001|TWO_SIDED|95.0|5.0|13.1|||ANCOVA|P-value is from ANCOVA model with treatment and center as factors and Baseline hair count as a covariate.||Intent to Treat (ITT) population defined as all participants randomly assigned to a treatment group who received dispensed investigational product. Four participants in vehicle group and 3 participants in foam group had no hair information at Baseline. Statistical analysis is of the change from baseline to week 24 data.||13.1|5.0|<0.0001
72486427|NCT01226459|144501167|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.8|||<|0.0001|TWO_SIDED|95.0|7.0|14.7|||ANCOVA|P-value is from ANCOVA model with treatment and center as factors and Baseline hair count as a covariate.||Statistical analysis is of the change from baseline to week 12 data.||14.7|7.0|<0.0001
72486428|NCT01226459|144501168|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.69|||<|0.0001|TWO_SIDED|95.0|0.35|1.04|||ANCOVA|||||1.04|0.35|<0.0001
72486429|NCT03770091|144501176|SUPERIORITY|ANOVA performed||||||0.6|||||||ANOVA|||||||0.6
72513403|NCT02491073|144556912|OTHER|There is no hypothesis testing in this study. The sample size was determined outside of statistical considerations; it was required by the U.S. Food and Drug Administration (FDA) in the New Drug Application 022416 Approval Letter issued on 08 November 2013 for PMR 2099-9.|geotmetric mean ratio|1.02|||||TWO_SIDED|90.0|1.0|1.03|||||parameter dispersion type - geometric coefficient of variation dispersion value - 0.041|FT3|In each geometric mean ratio estimate, free thyroid hormone levels in the spiked serum samples (LS or MS or HS) represent the numerator; free thyroid hormone levels in non-spiked serum samples (NS) represent the denominator|1.03|1.00|
72567853|NCT00361335|144667317|SUPERIORITY_OR_OTHER|||||||0.738||95.0|||||2-sided ANOVA on van der Waerden|||Hypothesis: Null hypothesis: No difference in change from baseline in PCS score of SF-36 at Wk 14 comparing Groups II vs V at 0.05 level of significance.||||0.738
72486430|NCT03770091|144501177|SUPERIORITY|||||||0.59|||||||ANOVA|||||||0.59
72567854|NCT00361335|144667317|SUPERIORITY_OR_OTHER|||||||0.788||95.0||||No adjustments were made to control for multiplicity|2-sided ANOVA on van der Waerden|||Hypothesis: Null hypothesis: No difference in change from baseline in PCS score of SF-36 at Wk 14 comparing Groups V vs I, V vs III, V vs II, and V vs IV at 0.05 level of significance.||||0.788
72486431|NCT03770091|144501178|SUPERIORITY|||||||0.9|||||||ANOVA|||||||0.9
72486432|NCT03770091|144501179|SUPERIORITY|||||||0.45|||||||ANCOVA|||||||0.45
72486433|NCT03770091|144501180|SUPERIORITY|||||||0.5|||||||ANOVA|||||||0.5
72486434|NCT01092143|144501210|SUPERIORITY||Adjusted mean treatment differences|3.083|STANDARD_DEVIATION|1.65||0.0311|TWO_SIDED|95.0|-0.157|6.323||α=0.025 one-sided|Mixed Models Analysis|MMRM with baseline, treatment, day, treatment by day interaction and baseline by day interaction as fixed effects and patient as a random effect.||Superiority in mean trough FEV1 % predicted change from baseline in patients treated with BI 671800 50 mg b.i.d. compared with those treated with placebo, after 6 weeks.||6.323|-0.157|0.0311
72567855|NCT03399318|144667332|SUPERIORITY||||||<|0.0001||||||treatment group as the factor of interest, country and disease severity 207 (CM=yes, no) as stratification factors, and admission temperature as a covariate. A t-test for significance of the treatment effect, were derived from this model.|t-test, 2 sided|||The analysis of the primary outcome variable, Tmax, involved fitting an analysis of 206 covariance model with treatment group as the factor of interest, country and disease severity 207 (CM=yes, no) as stratification factors, and admission temperature as a covariate. The estimated 208 treatment effect and associated 95% confidence interval, as well as a t-test for significance of the treatment effect, were derived from this model.||||<0.0001
72486435|NCT01092143|144501210|SUPERIORITY||Adjusted mean treatment differences|3.589|STANDARD_DEVIATION|1.6||0.0126|TWO_SIDED|95.0|0.447|6.732||α=0.025 one-sided|Mixed Models Analysis|MMRM with baseline, treatment, day, trea||Superiority in mean trough FEV1 % predicted change from baseline in patients treated with BI 671800 200 mg b.i.d. compared with those treated with placebo, after 6 weeks.||6.732|0.447|0.0126
72486436|NCT01092143|144501210|SUPERIORITY||Adjusted mean treatment differences|3.977|STANDARD_DEVIATION|1.64||0.0078|TWO_SIDED|95.0|0.756|7.197||α=0.025 one-sided|Mixed Models Analysis|MMRM with baseline, treatment, day, treatment by day interaction and baseline by day interaction as fixed effects and patient as a random effect.||Superiority in mean trough FEV1 % predicted change from baseline in patients treated with BI 671800 400 mg b.i.d. compared with those treated with placebo, after 6 weeks.||7.197|0.756|0.0078
72486437|NCT01092143|144501210|OTHER||Adjusted mean treatment differences|8.619|STANDARD_DEVIATION|1.684|<|0.0001|TWO_SIDED|95.0|5.312|11.927||α=0.025 one-sided|Mixed Models Analysis|MMRM with baseline, treatment, day, treatment by day interaction and baseline by day interaction as fixed effects and patient as a random effect.||Superiority in mean trough FEV1 % predicted change from baseline in patients treated with fluticasone propionate 110 mcg 2 puffs b.i.d. compared with those treated with placebo, after 6 weeks.||11.927|5.312|<.0001
72486438|NCT01092143|144501210|SUPERIORITY||Adjusted mean treatment differences|-5.536|STANDARD_DEVIATION|1.653||0.9996|TWO_SIDED|95.0|-8.783|-2.29||α=0.025 one-sided|Mixed Models Analysis|MMRM with baseline, treatment, day, treatment by day interaction and baseline by day interaction as fixed effects and patient as a random effect.||Superiority in mean trough FEV1 % predicted change from baseline in patients treated with BI 671800 50 mg b.i.d. compared with those treated with fluticasone propionate 220 mcg b.i.d., after 6 weeks.||-2.290|-8.783|0.9996
72486439|NCT01092143|144501210|SUPERIORITY||Adjusted mean treatment differences|-5.03|STANDARD_DEVIATION|1.606||0.9991|TWO_SIDED|95.0|-8.185|-1.875||α=0.025 one-sided|Mixed Models Analysis|MMRM with baseline, treatment, day, treatment by day interaction and baseline by day interaction as fixed effects and patient as a random effect.||Superiority in mean trough FEV1 % predicted change from baseline in patients treated with BI 671800 200 mg b.i.d. compared with those treated with fluticasone propionate 220mcg b.i.d., after 6 weeks.||-1.875|-8.185|0.9991
72513404|NCT02491073|144556912|OTHER|There is no hypothesis testing in this study. The sample size was determined outside of statistical considerations; it was required by the U.S. Food and Drug Administration (FDA) in the New Drug Application 022416 Approval Letter issued on 08 November 2013 for PMR 2099-9.|geometric mean ratio|1.03|||||TWO_SIDED|90.0|1.02|1.04|||||parameter dispersion type - geometric coefficient of variation dispersion value - 0.041|FT3|In each geometric mean ratio estimate, free thyroid hormone levels in the spiked serum samples (LS or MS or HS) represent the numerator; free thyroid hormone levels in non-spiked serum samples (NS) represent the denominator|1.04|1.02|
72513405|NCT02491073|144556913|OTHER|There is no hypothesis testing in this study. The sample size was determined outside of statistical considerations; it was required by the U.S. Food and Drug Administration (FDA) in the New Drug Application 022416 Approval Letter issued on 08 November 2013 for PMR 2099-9.|geometric mean ratio|1.0|||||TWO_SIDED|90.0|1.0|1.01|||||parameter dispersion type - geometric coefficient of variation dispersion value -0.018|TSH|In each geometric mean ratio estimate, thyroid hormone levels in the spiked serum samples (LS or MS or HS) represent the numerator; thyroid hormone levels in non-spiked serum samples (NS) represent the denominator|1.01|1.00|
72513406|NCT02491073|144556913|OTHER|There is no hypothesis testing in this study. The sample size was determined outside of statistical considerations; it was required by the U.S. Food and Drug Administration (FDA) in the New Drug Application 022416 Approval Letter issued on 08 November 2013 for PMR 2099-9.|geometric mean ratio|1.0|||||TWO_SIDED|90.0|1.0|1.01|||||parameter dispersion type - geometric coefficient of variation dispersion value - 0.018|TSH|In each geometric mean ratio estimate, thyroid hormone levels in the spiked serum samples (LS or MS or HS) represent the numerator; thyroid hormone levels in non-spiked serum samples (NS) represent the denominator|1.01|1.00|
72513407|NCT02491073|144556913|OTHER|There is no hypothesis testing in this study. The sample size was determined outside of statistical considerations; it was required by the U.S. Food and Drug Administration (FDA) in the New Drug Application 022416 Approval Letter issued on 08 November 2013 for PMR 2099-9.|geometric mean ratio|1.0|||||TWO_SIDED|90.0|1.0|1.01|||||parameter dispersion type - geometric coefficient of variation dispersion value - 0.018|TSH||1.01|1.00|
72513408|NCT02491073|144556913|OTHER|There is no hypothesis testing in this study. The sample size was determined outside of statistical considerations; it was required by the U.S. Food and Drug Administration (FDA) in the New Drug Application 022416 Approval Letter issued on 08 November 2013 for PMR 2099-9.|Geometric mean ratio|1.0|||||TWO_SIDED|90.0|0.99|1.02|||||parameter dispersion type - geometric coefficient of variation dispersion value - 0.041|TT4|In each geometric mean ratio estimate, thyroid hormone levels in the spiked serum samples (LS or MS or HS) represent the numerator; thyroid hormone levels in non-spiked serum samples (NS) represent the denominator.|1.02|0.99|
72567856|NCT03399318|144667333|SUPERIORITY||Odds Ratio (OR)|0.09|||<|0.05|TWO_SIDED|95.0|0.03|0.27|||Regression, Logistic|||Seizure occurrence defined as a three-level ordinal variable was analyzed using a 223 multinomial logistic regression model because there was evidence that the proportional odds 224 assumption did not hold. This model included treatment group as the factor of interest and 225 country and disease severity as stratification factors. The adjusted treatment group odds ratio, 226 and its associated 95% confidence interval were derived from this model.||.27|.03|<0.05
72576934|NCT00261443|144680718|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|1.01||||0.987|TWO_SIDED|95.0|0.54|1.86||CMH General Association Test controlling for mood stabilizer.|Cochran-Mantel-Haenszel|||"At Any Time Treatment Comparison"||1.86|0.54|0.987
72576935|NCT00261443|144680719|SUPERIORITY_OR_OTHER_LEGACY|||||||0.646||95.0||||ANOVA model, controlling for treatment and mood stabilizer, is used for baseline. ANCOVA model on the rank of the change from baseline, controlling for treatment, mood stabilizer, and the rank of baseline is used for change from baseline.|ANOVA/ANCOVA|||Treatment Comparison Baseline||||0.646
72576936|NCT00261443|144680719|SUPERIORITY_OR_OTHER_LEGACY|||||||0.006||95.0||||ANOVA model, controlling for treatment and mood stabilizer, is used for baseline. ANCOVA model on the rank of the change from baseline, controlling for treatment, mood stabilizer, and the rank of baseline is used for change from baseline.|ANOVA/ANCOVA|||Week 12 Treatment Comparison||||0.006
72576937|NCT00261443|144680719|SUPERIORITY_OR_OTHER_LEGACY|||||||0.485||95.0||||ANOVA model, controlling for treatment and mood stabilizer, is used for baseline. ANCOVA model on the rank of the change from baseline, controlling for treatment, mood stabilizer, and the rank of baseline is used for change from baseline.|ANOVA/ANCOVA|||Week 24 Treatment Comparison||||0.485
72576938|NCT00261443|144680719|SUPERIORITY_OR_OTHER_LEGACY|||||||0.325||95.0||||ANOVA model, controlling for treatment and mood stabilizer, is used for baseline. ANCOVA model on the rank of the change from baseline, controlling for treatment, mood stabilizer, and the rank of baseline is used for change from baseline.|ANOVA/ANCOVA|||Week 36 Treatment Comparison||||0.325
72576939|NCT00261443|144680719|SUPERIORITY_OR_OTHER_LEGACY|||||||0.374||95.0||||ANOVA model, controlling for treatment and mood stabilizer, is used for baseline. ANCOVA model on the rank of the change from baseline, controlling for treatment, mood stabilizer, and the rank of baseline is used for change from baseline.|ANOVA/ANCOVA|||Week 52 Treatment Comparison||||0.374
72576940|NCT00261443|144680719|SUPERIORITY_OR_OTHER_LEGACY|||||||0.064||95.0||||ANOVA model, controlling for treatment and mood stabilizer, is used for baseline. ANCOVA model on the rank of the change from baseline, controlling for treatment, mood stabilizer, and the rank of baseline is used for change from baseline.|ANOVA/ANCOVA|||Week 52 (LOCF) Treatment Comparison||||0.064
72576941|NCT00261443|144680719|SUPERIORITY_OR_OTHER_LEGACY|||||||0.31||95.0||||ANOVA model, controlling for treatment and mood stabilizer, is used for baseline. ANCOVA model on the rank of the change from baseline, controlling for treatment, mood stabilizer, and the rank of baseline is used for change from baseline.|ANOVA/ANCOVA|||Highest Value Treatment Comparison||||0.310
72576942|NCT00261443|144680719|SUPERIORITY_OR_OTHER_LEGACY|||||||0.046||95.0||||ANOVA model, controlling for treatment and mood stabilizer, is used for baseline. ANCOVA model on the rank of the change from baseline, controlling for treatment, mood stabilizer, and the rank of baseline is used for change from baseline.|ANOVA/ANCOVA|||Lowest Value Treatment Comparison||||0.046
72576943|NCT00261443|144680721|SUPERIORITY_OR_OTHER_LEGACY|||||||0.331||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Baseline ALP||||0.331
72576944|NCT00261443|144680721|SUPERIORITY_OR_OTHER_LEGACY|||||||0.353||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Change from Baseline in ALP at Week 52 (LOCF)||||0.353
72576945|NCT00261443|144680721|SUPERIORITY_OR_OTHER_LEGACY|||||||0.298||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison ALP Highest Change Value During Phase 3||||0.298
72576946|NCT00261443|144680722|SUPERIORITY_OR_OTHER_LEGACY|||||||0.111||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Baseline ALT||||0.111
72576947|NCT00261443|144680722|SUPERIORITY_OR_OTHER_LEGACY|||||||0.948||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Change in ALT at Week 52 (LOCF)||||0.948
72576948|NCT00261443|144680722|SUPERIORITY_OR_OTHER_LEGACY|||||||0.559||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison ALT Highest Change Value During Phase 3||||0.559
72576949|NCT00261443|144680723|SUPERIORITY_OR_OTHER_LEGACY|||||||0.077||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Baseline AST||||0.077
72576950|NCT00261443|144680723|SUPERIORITY_OR_OTHER_LEGACY|||||||0.255||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Change in AST at Week 52 (LOCF)||||0.255
72576951|NCT00261443|144680723|SUPERIORITY_OR_OTHER_LEGACY|||||||0.918||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison AST Highest Change Value During Phase 3||||0.918
72576952|NCT00261443|144680724|SUPERIORITY_OR_OTHER_LEGACY|||||||0.118||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Baseline BUN||||0.118
72576953|NCT00261443|144680724|SUPERIORITY_OR_OTHER_LEGACY|||||||0.532||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Change from Baseline in BUN at Week 52 (LOCF)||||0.532
72576954|NCT00261443|144680724|SUPERIORITY_OR_OTHER_LEGACY|||||||0.169||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison BUN Highest Value of Change During Phase 3||||0.169
72576955|NCT00261443|144680725|SUPERIORITY_OR_OTHER_LEGACY|||||||0.878||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Baseline Total Cholesterol (fasting)||||0.878
72576956|NCT00261443|144680725|SUPERIORITY_OR_OTHER_LEGACY|||||||0.544||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Change from Baseline in Total Cholesterol (fasting) at Week 52 (LOCF)||||0.544
72576957|NCT00261443|144680725|SUPERIORITY_OR_OTHER_LEGACY|||||||0.658||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Highest Value of Change in Total Cholesterol (fasting) in Phase 3||||0.658
72576958|NCT00261443|144680726|SUPERIORITY_OR_OTHER_LEGACY|||||||0.043||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Baseline Creatine Kinase||||0.043
72576959|NCT00261443|144680726|SUPERIORITY_OR_OTHER_LEGACY|||||||0.019||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Change from baseline in Creatine Kinase at Week 52 (LOCF)||||0.019
72576960|NCT00261443|144680726|SUPERIORITY_OR_OTHER_LEGACY|||||||0.176||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Highest Value of Change in Creatine Kinase During Phase 3||||0.176
72486440|NCT01092143|144501210|SUPERIORITY||Adjusted mean treatment differences|-4.643|STANDARD_DEVIATION|1.647||0.9975|TWO_SIDED|95.0|-7.877|-1.408||α=0.025 one-sided|Mixed Models Analysis|MMRM with baseline, treatment, day, treatment by day interaction and baseline by day interaction as fixed effects and patient as a random effect.||Superiority in mean trough FEV1 % predicted change from baseline in patients treated with BI 671800 400 mg b.i.d. compared with those treated with fluticasone propionate 220 mcg b.i.d., after 6 weeks.||-1.408|-7.877|0.9975
72486441|NCT01092143|144501211|SUPERIORITY||Adjusted mean treatment differences|0.073|STANDARD_DEVIATION|0.113||0.7413|TWO_SIDED|95.0|-0.149|0.295||α=0.025 one-sided|Mixed Models Analysis|MMRM with baseline, treatment, day, treatment by day interaction and baseline by day interaction as fixed effects and patient as a random effect.||||0.295|-0.149|0.7413
72486442|NCT01092143|144501211|SUPERIORITY||Adjusted mean treatment differences|-0.08|STANDARD_DEVIATION|0.11||0.2335|TWO_SIDED|95.0|-0.296|0.136||α=0.025 one-sided|Mixed Models Analysis|MMRM with baseline, treatment, day, treatment by day interaction and baseline by day interaction as fixed effects and patient as a random effect.||||0.136|-0.296|0.2335
72486443|NCT01092143|144501211|SUPERIORITY||Adjusted mean treatment differences|-0.061|STANDARD_DEVIATION|0.113||0.2933|TWO_SIDED|95.0|-0.282|0.16||α=0.025 one-sided|Mixed Models Analysis|MMRM with baseline, treatment, day, treatment by day interaction and baseline by day interaction as fixed effects and patient as a random effect.||||0.160|-0.282|0.2933
72513409|NCT02491073|144556913|OTHER|There is no hypothesis testing in this study. The sample size was determined outside of statistical considerations; it was required by the U.S. Food and Drug Administration (FDA) in the New Drug Application 022416 Approval Letter issued on 08 November 2013 for PMR 2099-9.|Slope|1.01|||||TWO_SIDED|90.0|1.0|1.02|||||parameter dispersion type - geometric coefficient of variation dispersion value - 0.033|TT4|In each geometric mean ratio estimate, thyroid hormone levels in the spiked serum samples (LS or MS or HS) represent the numerator; thyroid hormone levels in non-spiked serum samples (NS) represent the denominator|1.02|1.00|
72513410|NCT02491073|144556913|OTHER|There is no hypothesis testing in this study. The sample size was determined outside of statistical considerations; it was required by the U.S. Food and Drug Administration (FDA) in the New Drug Application 022416 Approval Letter issued on 08 November 2013 for PMR 2099-9.|geometric mean ratio|1.0|||||TWO_SIDED|90.0|0.99|1.01|||||parameter dispersion type - geometric coefficient of variation dispersion value - 0.036|TT4|In each geometric mean ratio estimate, thyroid hormone levels in the spiked serum samples (LS or MS or HS) represent the numerator; thyroid hormone levels in non-spiked serum samples (NS) represent the denominator|1.01|0.99|
72513411|NCT02491073|144556913|OTHER|There is no hypothesis testing in this study. The sample size was determined outside of statistical considerations; it was required by the U.S. Food and Drug Administration (FDA) in the New Drug Application 022416 Approval Letter issued on 08 November 2013 for PMR 2099-9.|geometric mean ratio|0.99|||||TWO_SIDED|90.0|0.98|1.01|||||parameter dispersion type - geometric coefficient of variation dispersion value - 0.047|TT3|In each geometric mean ratio estimate, thyroid hormone levels in the spiked serum samples (LS or MS or HS) represent the numerator; thyroid hormone levels in non-spiked serum samples (NS) represent the denominator|1.01|0.98|
72513412|NCT02491073|144556913|OTHER|There is no hypothesis testing in this study. The sample size was determined outside of statistical considerations; it was required by the U.S. Food and Drug Administration (FDA) in the New Drug Application 022416 Approval Letter issued on 08 November 2013 for PMR 2099-9.|geometric mean ratio|1.0|||||TWO_SIDED|90.0|0.98|1.01|||||parameter dispersion type - geometric coefficient of variation dispersion value - 0.043|TT3|In each geometric mean ratio estimate, thyroid hormone levels in the spiked serum samples (LS or MS or HS) represent the numerator; thyroid hormone levels in non-spiked serum samples (NS) represent the denominator|1.01|0.98|
72513413|NCT02491073|144556913|OTHER|There is no hypothesis testing in this study. The sample size was determined outside of statistical considerations; it was required by the U.S. Food and Drug Administration (FDA) in the New Drug Application 022416 Approval Letter issued on 08 November 2013 for PMR 2099-9.|geometric mean ratio|0.99|||||TWO_SIDED|90.0|0.97|1.0|||||parameter dispersion type - geometric coefficient of variation dispersion value - 0.048|TT3|In each geometric mean ratio estimate, thyroid hormone levels in the spiked serum samples (LS or MS or HS) represent the numerator; thyroid hormone levels in non-spiked serum samples (NS) represent the denominator|1.00|0.97|
72576961|NCT00261443|144680727|SUPERIORITY_OR_OTHER_LEGACY|||||||0.105||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Baseline Creatinine||||0.105
72486444|NCT01092143|144501211|SUPERIORITY||Adjusted mean treatment differences|-0.333|STANDARD_DEVIATION|0.116||0.0021|TWO_SIDED|95.0|-0.561|-0.105||α=0.025 one-sided|Mixed Models Analysis|MMRM with baseline, treatment, day, treatment by day interaction and baseline by day interaction as fixed effects and patient as a random effect.||||-0.105|-0.561|0.0021
72486445|NCT01092143|144501211|SUPERIORITY||Adjusted mean treatment differences|0.406|STANDARD_DEVIATION|0.114||0.9998|TWO_SIDED|95.0|0.183|0.63||α=0.025 one-sided|Mixed Models Analysis|MMRM with baseline, treatment, day, treatment by day interaction and baseline by day interaction as fixed effects and patient as a random effect.||||0.630|0.183|0.9998
72576962|NCT00261443|144680727|SUPERIORITY_OR_OTHER_LEGACY|||||||0.634||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Change from Baseline in Creatinine at Week 52 (LOCF)||||0.634
72576963|NCT00261443|144680727|SUPERIORITY_OR_OTHER_LEGACY|||||||0.958||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Highest Value of Change in Creatinine During Phase 3||||0.958
72576964|NCT00261443|144680728|SUPERIORITY_OR_OTHER_LEGACY|||||||0.507||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Baseline Eosinophils (relative)||||0.507
72486446|NCT01092143|144501211|SUPERIORITY||Adjusted mean treatment differences|0.253|STANDARD_DEVIATION|0.11||0.989|TWO_SIDED|95.0|0.037|0.47||α=0.025 one-sided|Mixed Models Analysis|MMRM with baseline, treatment, day, treatment by day interaction and baseline by day interaction as fixed effects and patient as a random effect.||||0.470|0.037|0.9890
72576965|NCT00261443|144680728|SUPERIORITY_OR_OTHER_LEGACY|||||||0.834||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Change from Baseline in Eosinophils (relative) at Week 52 (LOCF)||||0.834
72576966|NCT00261443|144680728|SUPERIORITY_OR_OTHER_LEGACY|||||||0.511||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Highest Value of Change in Eosinophils (relative) During Phase 3||||0.511
72513414|NCT02491073|144556914|OTHER|There is no hypothesis testing in this study. The sample size was determined outside of statistical considerations; it was required by the U.S. Food and Drug Administration (FDA) in the New Drug Application 022416 Approval Letter issued on 08 November 2013 for PMR 2099-9.|geometric mean ratio|1.11|||||TWO_SIDED|90.0|1.06|1.16|||||parameter dispersion type - geometric coefficient of variation dispersion value - 0.148|FT4|In each geometric mean ratio estimate, free thyroid hormone levels as measured by the automated kit assay represent the numerator; free thyroid hormone levels as measured by the optimized equilibrium dialysis method represent the denominator|1.16|1.06|
72513415|NCT02491073|144556914|OTHER|There is no hypothesis testing in this study. The sample size was determined outside of statistical considerations; it was required by the U.S. Food and Drug Administration (FDA) in the New Drug Application 022416 Approval Letter issued on 08 November 2013 for PMR 2099-9.|geometric mean ratio|1.13|||||TWO_SIDED|90.0|1.07|1.2|||||parameter dispersion type - geometric coefficient of variation dispersion value - 0.202|FT4|In each geometric mean ratio estimate, free thyroid hormone levels as measured by the automated kit assay represent the numerator; free thyroid hormone levels as measured by the optimized equilibrium dialysis method represent the denominator|1.20|1.07|
72513416|NCT02491073|144556914|OTHER|There is no hypothesis testing in this study. The sample size was determined outside of statistical considerations; it was required by the U.S. Food and Drug Administration (FDA) in the New Drug Application 022416 Approval Letter issued on 08 November 2013 for PMR 2099-9.|geometric mean ratio|1.11|||||TWO_SIDED|90.0|1.04|1.18|||||parameter dispersion type - geometric coefficient of variation dispersion value - 0.203|FT4|In each geometric mean ratio estimate, free thyroid hormone levels as measured by the automated kit assay represent the numerator; free thyroid hormone levels as measured by the optimized equilibrium dialysis method represent the denominator.|1.18|1.04|
72513417|NCT02491073|144556914|OTHER|There is no hypothesis testing in this study. The sample size was determined outside of statistical considerations; it was required by the U.S. Food and Drug Administration (FDA) in the New Drug Application 022416 Approval Letter issued on 08 November 2013 for PMR 2099-9.|geometric mean ratio|1.04|||||TWO_SIDED|90.0|0.99|1.1|||||parameter dispersion type - geometric coefficient of variation dispersion value - 0.179|FT4|In each geometric mean ratio estimate, free thyroid hormone levels as measured by the automated kit assay represent the numerator; free thyroid hormone levels as measured by the optimized equilibrium dialysis method represent the denominator.|1.10|0.99|
72513418|NCT02491073|144556914|OTHER|There is no hypothesis testing in this study. The sample size was determined outside of statistical considerations; it was required by the U.S. Food and Drug Administration (FDA) in the New Drug Application 022416 Approval Letter issued on 08 November 2013 for PMR 2099-9.|geometric mean ratio|1.21|||||TWO_SIDED|90.0|1.15|1.52|||||parameter dispersion type - geometric coefficient of variation dispersion value - 0.178|FT3|In each geometric mean ratio estimate, free thyroid hormone levels as measured by the automated kit assay represent the numerator; free thyroid hormone levels as measured by the optimized equilibrium dialysis method represent the denominator|1.52|1.15|
72513419|NCT02491073|144556914|OTHER|There is no hypothesis testing in this study. The sample size was determined outside of statistical considerations; it was required by the U.S. Food and Drug Administration (FDA) in the New Drug Application 022416 Approval Letter issued on 08 November 2013 for PMR 2099-9.|geometric mean ratio|1.42|||||TWO_SIDED|90.0|1.33|1.52|||||parameter dispersion type - geometric coefficient of variation dispersion value - 0.224|FT3|In each geometric mean ratio estimate, free thyroid hormone levels as measured by the automated kit assay represent the numerator; free thyroid hormone levels as measured by the optimized equilibrium dialysis method represent the denominator|1.52|1.33|
72567857|NCT03399318|144667334|SUPERIORITY||Odds Ratio, log|6.3|||<|0.05|TWO_SIDED|95.0|-5.1|17.7||The covariance matrix for the within-participant observations was 232 modeled using an unstructured pattern.|ANCOVA|Time to parasite clearance was 235 evaluated using a discrete-time proportional hazards model with a complementary log-log link.|The adjusted treatment group difference in mean area 233 under the log10(HRP2 level) × time curve was estimated using appropriate contrasts among the 234 treatment group means over time that quantify this comparison.|Parasite clearance measured by log10 (HRP2 level) was analyzed with a repeated 228 measures analysis of covariance model (mixed model repeated measures)35 with terms for 229 treatment group, country, disease severity, log10(HRP2 level) at admission, time (treated as a 230 categorical variable), and interaction terms for admission log10(HRP2 level) and time, and for 231 treatment group and time.|The model included terms for treatment group, country, and disease severity.|17.7|-5.1|<0.05
72567858|NCT03399318|144667335|SUPERIORITY||Odds Ratio (OR)|0.32|||<|0.05|TWO_SIDED|95.0|0.2|0.52||An ordinal logistic regression model assuming 216 proportional odds with terms for treatment group, country, and disease severity as covariates was used to derive the estimated adjusted treatment group odds ratio and 95%CI|Regression, Logistic|Sensitivity analyses with best-case and worst-case imputation were 219 performed to accommodate missing data||A secondary efficacy measure included fever exposure as measured by the area under 214 the temperature × time curve for T≥38.5°C during the 72-hour follow-up period, categorized as 215 0, \> 0 and \< 2, and ≥ 2 degree-hours.||.52|.20|<0.05
72567859|NCT02749292|144667336|EQUIVALENCE|Using a two-sided log-rank test with an alpha level of 0.05, a projected relapse risk of 15% in the superior group and 30% in the inferior group, and an estimated enrollment time of 36 months, it was determined that 200 patients were required to detect a significant difference with a power of 0.80. Due to the coronavirus disease 2019 (COVID-19) pandemic and the deleterious impact of rituximab on vaccination efficacy, the trial was concluded before reaching the target enrollment of 200.|Hazard Ratio (HR)|0.37||||0.045|TWO_SIDED|95.0|0.15|0.9|||Log Rank|||"The difference between the two treatment strategies was assessed using the log-rank test. P values of 0.05 were considered significant. Both rows were included and combined in the statistical analysis (ANCA-PR3 and ANCA-MPO) to assess the difference in treatment strategies.~Null hypothesis: No difference in the ANCA and B-cell arm in the probability of relapses."||0.90|0.15|0.045
72567860|NCT02749292|144667337|OTHER|chi square test||||||0.87|||||||Chi-squared|||"Null hypothesis: No difference in the proportion of patients with SAEs in each arm"||||0.87
72567861|NCT02749292|144667342|OTHER||||||<|1|TWO_SIDED|95.0|||||t-test, 2 sided|||Null hypothesis: no difference in the mean number of infusions per patient in each arm.||||<0001
72567862|NCT02749292|144667343|OTHER||Mean Difference (Final Values)|-0.14||||0.17|TWO_SIDED|95.0|-0.34|-0.06|||t-test, 2 sided|||Null hypothesis: there is no difference in the mean change from baseline Vasculitis Damage Index between each arm. A t-test was used.||-0.06|-0.34|0.17
72576967|NCT00261443|144680729|SUPERIORITY_OR_OTHER_LEGACY|||||||0.741||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Baseline Glucose (fasting)||||0.741
72513420|NCT02491073|144556914|OTHER|There is no hypothesis testing in this study. The sample size was determined outside of statistical considerations; it was required by the U.S. Food and Drug Administration (FDA) in the New Drug Application 022416 Approval Letter issued on 08 November 2013 for PMR 2099-9.|geometric mean ratio|1.19|||||TWO_SIDED|90.0|1.12|1.27|||||parameter dispersion type - geometric coefficient of variation dispersion value - 0.203|FT3|In each geometric mean ratio estimate, free thyroid hormone levels as measured by the automated kit assay represent the numerator; free thyroid hormone levels as measured by the optimized equilibrium dialysis method represent the denominator|1.27|1.12|
72513421|NCT02491073|144556914|OTHER|There is no hypothesis testing in this study. The sample size was determined outside of statistical considerations; it was required by the U.S. Food and Drug Administration (FDA) in the New Drug Application 022416 Approval Letter issued on 08 November 2013 for PMR 2099-9.|geometric mean ratio|1.19|||||TWO_SIDED|90.0|1.11|1.27|||||parameter dispersion type - geometric coefficient of variation dispersion value - 0.215|FT3|In each geometric mean ratio estimate, free thyroid hormone levels as measured by the automated kit assay represent the numerator; free thyroid hormone levels as measured by the optimized equilibrium dialysis method represent the denominator|1.27|1.11|
72513422|NCT02491073|144556915|OTHER|There is no hypothesis testing in this study. The sample size was determined outside of statistical considerations; it was required by the U.S. Food and Drug Administration (FDA) in the New Drug Application 022416 Approval Letter issued on 08 November 2013 for PMR 2099-9.|geometric mean ratio|1.0|||||TWO_SIDED|90.0|1.0|1.01|||||parameter dispersion type - geometric coefficient of variation dispersion value -0.018|TSH|In each geometric mean ratio estimate, thyroid hormone levels in the spiked serum samples (LS or MS or HS) represent the numerator; thyroid hormone levels in non-spiked serum samples (NS) represent the denominator|1.01|1.00|
72513423|NCT02491073|144556915|OTHER|There is no hypothesis testing in this study. The sample size was determined outside of statistical considerations; it was required by the U.S. Food and Drug Administration (FDA) in the New Drug Application 022416 Approval Letter issued on 08 November 2013 for PMR 2099-9.|geometric mean ratio|1.0|||||TWO_SIDED|90.0|1.0|1.01|||||parameter dispersion type - geometric coefficient of variation dispersion value - 0.018|TSH|In each geometric mean ratio estimate, thyroid hormone levels in the spiked serum samples (LS or MS or HS) represent the numerator; thyroid hormone levels in non-spiked serum samples (NS) represent the denominator|1.01|1.00|
72513424|NCT02491073|144556915|OTHER|There is no hypothesis testing in this study. The sample size was determined outside of statistical considerations; it was required by the U.S. Food and Drug Administration (FDA) in the New Drug Application 022416 Approval Letter issued on 08 November 2013 for PMR 2099-9.|geometric mean ratio|1.0|||||TWO_SIDED|90.0|1.0|1.01|||||parameter dispersion type - geometric coefficient of variation dispersion value - 0.018|TSH||1.01|1.00|
72513425|NCT01419665|144556921|EQUIVALENCE|The equivalence margin of + or - 12% was determined considering the variability of the point estimate of the add-on effect by taking a value lower than the lower boundary of the 95% CI for Rituximab+chemotherapy versus chemotherapy obtained from historical data.|difference in overall response rate|-0.4|||||TWO_SIDED|95.0|-5.94|5.14|||Binomial approximation|||||5.14|-5.94|
72513426|NCT01419665|144556924|OTHER|descriptive purposes, not powered for hypothesis testing|Hazard Ratio (HR)|1.3|||||TWO_SIDED|95.0|0.97|1.76|||Regression, Cox|||||1.76|0.97|
72513427|NCT01419665|144556925|OTHER|descriptive purposes, not powered for hypothesis testing|Hazard Ratio (HR)|0.92|||||TWO_SIDED|95.0|0.55|1.52|||Regression, Cox|||||1.52|0.55|
72513428|NCT00485589|144556991|NON_INFERIORITY|Pre-specified analysis||||||0.001|||||||Van Elteren's test|||||||0.001
72513429|NCT00485589|144556991|NON_INFERIORITY|Pre-specified analysis||||||0.0033|||||||Van Elteren's test|||||||0.0033
72513430|NCT03377244|144557006|SUPERIORITY|||||||0.1013||||||The p-value above reflects results of between-arms analysis of percent change in weight from baseline to 6 months post-intervention.|general linear model|Model adjusted for age, sex, education, marital status, and employment status.||||||0.1013
72513431|NCT03377244|144557007|SUPERIORITY|||||||0.495||||||The p-value above reflects results of between-arms analysis of change in mean HbA1c from baseline to 6 months post-intervention.|general linear model|Model adjusted for age, sex, education, marital status, and employment.||||||0.4950
72576968|NCT00261443|144680729|SUPERIORITY_OR_OTHER_LEGACY|||||||0.962||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Change from Baseline in Glucose (fasting) at Week 52 (LOCF)||||0.962
72513432|NCT03377244|144557008|SUPERIORITY|||||||0.7416||||||The p-value above reflects results of between-arms analysis of change in systolic blood pressure from baseline to 6 months post-intervention.|general linear model|Model adjusted for age, sex, education, marital status, and employment status.||||||0.7416
72513433|NCT03377244|144557009|SUPERIORITY|||||||0.0702||||||The p-value above reflects results of between-arms analysis of change in diastolic blood pressure from baseline to 6 months post-intervention.|general linear model|Model adjusted for age, sex, education, marital status, and employment status.||||||0.0702
72513434|NCT03377244|144557010|SUPERIORITY|||||||0.007||||||The p-value above reflects results of between-arms analysis of change in eating habits self-efficacy scores from baseline to 6 months post-intervention.|general linear model|Model adjusted for age, sex, education, marital status, and employment status.||||||0.0070
72513435|NCT03377244|144557011|SUPERIORITY|||||||0.0009||||||The p-value above reflects results of between-arms analysis of change in physical activity self-efficacy scale scores from baseline to 6 months post-intervention.|general linear model|Model adjusted for age, sex, education, marital status, and employment status.||||||0.0009
72576969|NCT00261443|144680729|SUPERIORITY_OR_OTHER_LEGACY|||||||0.592||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Highest Change Value in Glucose (fasting) During Phase 3||||0.592
72576970|NCT00261443|144680730|SUPERIORITY_OR_OTHER_LEGACY|||||||0.08||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Baseline Hemoglobin||||0.080
72513436|NCT03377244|144557012|SUPERIORITY|||||||0.374||||||The p-value above reflects results of between-arms analysis for the probability of participants to engage in sufficient physical activity at 6 months post-intervention.|Regression, Logistic|Model adjusted for age, sex, education, marital status, employment status, and baseline physical activity.||||||0.3740
72486447|NCT01092143|144501211|SUPERIORITY||Adjusted mean treatment differences|0.272|STANDARD_DEVIATION|0.113||0.9918|TWO_SIDED|95.0|0.05|0.494||α=0.025 one-sided|Mixed Models Analysis|MMRM with baseline, treatment, day, treatment by day interaction and baseline by day interaction as fixed effects and patient as a random effect.||||0.494|0.050|0.9918
72513437|NCT03377244|144557013|SUPERIORITY|||||||0.9556||||||The p-value above reflects results of between-arms analysis of change in participants' sugar-sweetened beverage consumption per day from baseline to 6 months post-intervention.|general linear model|Model adjusted for age, sex, education, marital status, and employment status.||||||0.9556
72513438|NCT03377244|144557014|SUPERIORITY|||||||0.1726||||||The p-value above reflects results of between-arms analysis of change in participants' fruit and vegetable consumption scale scores from baseline to 6 months post-intervention.|general linear model|Model adjusted for age, sex, education, marital status, and employment status.||||||0.1726
72513439|NCT03377244|144557015|SUPERIORITY|||||||0.0478||||||The p-value above reflects results of between-arms analysis of change in participants' family support scale scores from baseline to 6 months post-intervention.|general linear model|Model adjusted for age, sex, education, marital status, and employment status.||||||0.0478
72513440|NCT00174785|144557017|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.76|||<|0.0001||95.0|0.69|0.84||Cumulative incidence functions in each treatment group were calculated using non-parametric Kaplan-Meier estimates. Median time-to-event was not reached in any group. The primary comparison was performed at the 5% level using a 2-sided Log rank test.|Log Rank||The hazard ratio was estimated by a Cox's proportional hazard model with treatment arm factor. It represents the relative hazard of first hospitalization for cardiovascular reason or death for the dronedarone group compared with the placebo group.|||0.84|0.69|<0.0001
72513441|NCT00174785|144557018|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.84||||0.18||95.0|0.66|1.08||Cumulative incidences calculated in each group using non-parametric Kaplan-Meier estimates. Median time-to-event was not reached in any group. Hierarchical procedure applied to secondary efficacy endpoints testing to protect the global type I error.|Log Rank||The hazard ratio was estimated by a Cox's proportional hazard model with treatment arm factor. It represents the relative hazard of death from any cause for the dronedarone group compared with the placebo group.|||1.08|0.66|0.18
72513442|NCT00174785|144557019|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.74|||<|0.0001||95.0|0.67|0.82||Cumulative incidences calculated in each group using non-parametric Kaplan-Meier estimates. Median time-to-event was not reached in any group. Hierarchical procedure applied to secondary efficacy endpoints testing to protect the global type I error.|Log Rank||The hazard ratio was estimated by a Cox's proportional hazard model with treatment arm factor. It represents the relative hazard of first hospitalization for cardiovascular reason for the dronedarone group compared with the placebo group.|||0.82|0.67|<0.0001
72513443|NCT00174785|144557020|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.7||||0.025||95.0|0.51|0.96||Cumulative incidences calculated in each group using non-parametric Kaplan-Meier estimates. Median time-to-event was not reached in any group. Hierarchical procedure applied to secondary efficacy endpoints testing to protect the global type I error.|Log Rank||The hazard ratio was estimated by a Cox's proportional hazard model with treatment arm factor. It represents the relative hazard of cardiovascular death for the dronedarone group compared with the placebo group.|||0.96|0.51|0.025
72513444|NCT00174785|144557021|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.71||||0.03||95.0|0.51|0.98||Cumulative incidences calculated in each group using non-parametric Kaplan-Meier estimates. Median time-to-event was not reached in any group. The comparison was performed at the 5% level using a 2-sided Log rank|Log Rank||The hazard ratio was estimated by a Cox's proportional hazard model with treatment arm factor. It represents the relative hazard of adjudicated cardiovascular death for the dronedarone group compared with the placebo group.|||0.98|0.51|0.03
72513445|NCT00120289|144557028|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.02||||0.8|TWO_SIDED|95.0|0.87|1.21|||Regression, Cox|Adjusting for gender and history of diabetes (randomization stratification factors).||||1.21|0.87|0.80
72513446|NCT00120289|144557029|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.08||||0.49|TWO_SIDED|95.0|0.87|1.34|||Regression, Cox|||||1.34|0.87|.49
72513447|NCT00120289|144557030|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.13||||0.3|TWO_SIDED|95.0|0.9|1.42|||Regression, Cox|||||1.42|0.90|.30
72513448|NCT00120289|144557031|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.17||||0.47|TWO_SIDED|95.0|0.76|1.8|||Regression, Cox|||||1.80|0.76|0.47
72513449|NCT02504268|144557105|SUPERIORITY|||||||0.2359|||||||Regression, Logistic|||||||0.2359
72486448|NCT02774616|144501241|NON_INFERIORITY|A rejection of the null hypothesis (Ho) would demonstrate evidence that the complication-free rate is greater than 90.0% in the population.||||||0.0004|||||||exact binomial|||"Serious Adverse Device Effects (SADE) possibly or securely related to the Ilivia ICD family until the 3- month follow-up are counted for this primary endpoint. The following hypothesis has been defined:~Ho: SADE-free rate through 3 months post-implant ≤ 90.0% Ha: SADE-free rate through 3 months post-implant \> 90.0%"||||0.0004
72486449|NCT02774616|144501242|NON_INFERIORITY|A rejection of the null hypothesis (Ho) would demonstrate evidence that the complication-free rate is greater than 90.0% in the population.||||||0.0019|||||||exact binomial|||"Serious Adverse Device Effects (SADE) possibly or securely related to the Plexa ICD lead until the 6-month follow-up are counted for this primary endpoint. The following hypothesis has been defined:~Ho: SADE-free rate through 3 months post-implant ≤ 90.0% Ha: SADE-free rate through 3 months post-implant \> 90.0%"||||0.0019
72486450|NCT02774616|144501244|NON_INFERIORITY|This endpoint evaluates the rate of appropriate right ventricular sensing of all patients in which a sensing measurement was performed. The following hypothesis has been defined: Ho: Rate of appropriate sensing through 3 months post-implant ≤ 93.0% Ha: Rate of appropriate sensing through 3 months post-implant \> 93.0%|||||<|0.0001||||||A rejection of the null hypothesis (Ho) would demonstrate evidence that the rate of appropriate sensing is greater than 93.0% in the population.|exact binomial|||||||<0.0001
72513450|NCT02504268|144557106|SUPERIORITY|||||||0.0112|||||||Regression, Logistic|||||||0.0112
72513451|NCT02504268|144557107|SUPERIORITY|||||||0.0021|||||||Regression, Logistic|||||||0.0021
72513452|NCT02504268|144557108|SUPERIORITY||||||<|0.0001|||||||rank-based ANCOVA|||||||< 0.0001
72513453|NCT02504268|144557109|SUPERIORITY|||||||0.0006|||||||Regression, Logistic|||||||0.0006
72513454|NCT01580592|144557203|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.6|STANDARD_DEVIATION|7.6||0.001|TWO_SIDED||||||ANOVA||for omalizumab 150mg|||||0.001
72486451|NCT02774616|144501245|NON_INFERIORITY|A rejection of the null hypothesis (Ho) would demonstrate evidence that the rate of appropriate pacing is greater than 93.0% in the population.|||||<|0.0001|||||||exact binomial|||"This secondary hypothesis evaluates the rate of appropriate right ventricular pacing of all patients in which a pacing measurement was performed. The following hypothesis has been defined:~Ho: Rate of appropriate pacing through 3 months post-implant ≤ 93.0% Ha: Rate of appropriate pacing through 3 months post-implant \> 93.0%"||||<0.0001
72486452|NCT00397033|144501247|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||Cochran-Mantel-Haenszel|P-value is based on the CMH chi-square test with modified ridit scores, stratified by concomitant medication stratum, and country.||||||0.001
72486453|NCT00397033|144501247|SUPERIORITY_OR_OTHER|||||||0.008||95.0|||||Cochran-Mantel-Haenszel|P-value is based on the CMH chi-square test with modified ridit scores, stratified by concomitant medication stratum, and country.||||||0.008
72486454|NCT00397033|144501248|SUPERIORITY_OR_OTHER||LS Means Difference|-3.4|STANDARD_ERROR_OF_MEAN|0.9|<|0.001||95.0|-5.1|-1.7|||ANCOVA|P-value is from an ANCOVA model with fixed-effects for treatment, concomitant medication stratum, and country, and baseline value as a covariate.|Paliperidone Extended Release (ER) High Dose - Placebo on the Change Scores. Higher scores indicate worsening.|||-1.7|-5.1|<0.001
72486455|NCT00397033|144501248|SUPERIORITY_OR_OTHER||LS Means Difference|-1.1|STANDARD_ERROR_OF_MEAN|0.9||0.217||95.0|-2.8|0.6|||ANCOVA|P-value is from an ANCOVA model with fixed-effects for treatment, concomitant medication stratum, and country, and baseline value as a covariate.|Paliperidone Extended Release (ER) Low Dose - Placebo on the Change Scores. Higher scores indicate worsening.|||0.6|-2.8|0.217
72486456|NCT00397033|144501249|SUPERIORITY_OR_OTHER||LS Means Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.6||0.108||95.0|-2.3|0.2|||ANCOVA|P-value is from an ANCOVA model with fixed-effects for treatment, concomitant medication stratum, and country, and baseline value as a covariate.|Paliperidone Extended Release (ER) High Dose - Placebo on the Change Scores. Higher scores indicate worsening.|||0.2|-2.3|0.108
72486457|NCT00397033|144501249|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.6||0.43||95.0|-1.7|0.7|||ANCOVA|P-value is from an ANCOVA model with fixed-effects for treatment, concomitant medication stratum, and country, and baseline value as a covariate.|Paliperidone Extended Release (ER) Low Dose - Placebo on the Change Scores. Higher scores indicate worsening.|||0.7|-1.7|0.430
72486458|NCT00397033|144501250|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.9|STANDARD_ERROR_OF_MEAN|1.5||0.008||95.0|-6.7|-1.0|||ANCOVA|P-value is from an ANCOVA model with fixed-effects for treatment, concomitant medication stratum, and country, and baseline value as a covariate.|Paliperidone Extended Release (ER) High Dose - Placebo on the Change Scores. Higher scores indicate worsening.|||-1.0|-6.7|0.008
72486459|NCT00397033|144501250|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.0|STANDARD_ERROR_OF_MEAN|1.4||0.175||95.0|-4.8|0.9|||ANCOVA|P-value is from an ANCOVA model with fixed-effects for treatment, concomitant medication stratum, and country, and baseline value as a covariate.|Paliperidone Extended Release (ER) Low Dose - Placebo on the Change Scores. Higher scores indicate worsening.|||0.9|-4.8|0.175
72486460|NCT00397033|144501251|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.9|STANDARD_ERROR_OF_MEAN|0.9||0.001||95.0|-4.6|-1.1|||ANCOVA|P-value is from an ANCOVA model with fixed-effects for treatment, concomitant medication stratum and country, and baseline value as a covariate.|Paliperidone Extended Release (ER) High Dose - Placebo on the Change Scores. Higher scores indicate worsening.|||-1.1|-4.6|0.001
72486461|NCT00397033|144501251|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|0.9||0.209||95.0|-2.8|0.6|||ANCOVA|P-value is from an ANCOVA model with fixed-effects for treatment, concomitant medication stratum and country, and baseline value as a covariate.|Paliperidone Extended Release (ER) Low Dose - Placebo on the Change Scores. Higher scores indicate worsening.|||0.6|-2.8|0.209
72486462|NCT00397033|144501253|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.4|STANDARD_ERROR_OF_MEAN|1.6||0.032||95.0|-6.5|-0.3|||ANCOVA|P-value is from an ANCOVA model with fixed-effects for treatment, concomitant medication stratum and country, and baseline value as a covariate.|Paliperidone Extended Release (ER) High Dose - Placebo on the Change Scores. Higher scores indicate worsening.|||-0.3|-6.5|0.032
72486463|NCT00397033|144501253|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.8|STANDARD_ERROR_OF_MEAN|1.5||0.013||95.0|-6.8|-0.8|||ANCOVA|P-value is from an ANCOVA model with fixed-effects for treatment, concomitant medication stratum and country, and baseline value as a covariate.|Paliperidone Extended Release (ER) Low Dose - Placebo on the Change Scores. Higher scores indicate worsening.|||-0.8|-6.8|0.013
72486464|NCT00397033|144501254|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.6||0.232||95.0|-2.0|0.5|||ANCOVA|P-value is from an ANCOVA model with fixed-effects for treatment, concomitant medication stratum and country, and baseline value as a covariate.|Paliperidone Extended Release (ER) High Dose - Placebo on the Change Scores. Higher scores indicate worsening.|||0.5|-2.0|0.232
72486465|NCT00397033|144501254|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.6||0.31||95.0|-1.8|0.6|||ANCOVA|P-value is from an ANCOVA model with fixed-effects for treatment, concomitant medication stratum and country, and baseline value as a covariate.|Paliperidone Extended Release (ER) Low Dose - Placebo on the Change Scores. Higher scores indicate worsening.|||0.6|-1.8|0.310
72486466|NCT00397033|144501255|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.8|STANDARD_ERROR_OF_MEAN|0.6||0.004||95.0|-3.1|-0.6|||ANCOVA|P-value is from an ANCOVA model with fixed-effects for treatment, concomitant medication stratum and country, and baseline value as a covariate.|Paliperidone Extended Release (ER) High Dose - Placebo on the Change Scores. Higher scores indicate worsening.|||-0.6|-3.1|0.004
72486467|NCT00397033|144501255|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.6||0.269||95.0|-1.9|0.5|||ANCOVA|P-value is from an ANCOVA model with fixed-effects for treatment, concomitant medication stratum and country, and baseline value as a covariate.|Paliperidone Extended Release (ER) Low Dose - Placebo on the Change Scores. Higher scores indicate worsening.|||0.5|-1.9|0.269
72486468|NCT00397033|144501256|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.1|STANDARD_ERROR_OF_MEAN|0.6|<|0.001||95.0|-3.2|-1.0|||ANCOVA|P-value is from an ANCOVA model with fixed-effects for treatment, concomitant medication stratum and country, and baseline value as a covariate.|Paliperidone Extended Release (ER) High Dose - Placebo on the Change Scores. Higher scores indicate worsening.|||-1.0|-3.2|<0.001
72513455|NCT01580592|144557203|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.4|STANDARD_DEVIATION|9.4||0.01|TWO_SIDED||||||ANOVA|||||||0.01
72624127|NCT01892189|144778533|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.214|STANDARD_ERROR_OF_MEAN|0.15219||0.169|TWO_SIDED|95.0|-0.5233|0.0953|||ANOVA||Difference between least square means of TAK-063 30 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Right Substantia Nigra: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.0953|-0.5233|0.169
72624128|NCT01892189|144778533|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2641|STANDARD_ERROR_OF_MEAN|0.14118||0.07|TWO_SIDED|95.0|-0.551|0.0228|||ANOVA||Difference between least square means of TAK-063 3 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Left Thalamus: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.0228|-0.5510|0.070
72624129|NCT01892189|144778533|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.0854|STANDARD_ERROR_OF_MEAN|0.15234||0.579|TWO_SIDED|95.0|-0.395|0.2242|||ANOVA||Difference between least square means of TAK-063 10 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Left Thalamus: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.2242|-0.3950|0.579
72486469|NCT00397033|144501256|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.6||0.314||95.0|-1.7|0.5|||ANCOVA|P-value is from an ANCOVA model with fixed-effects for treatment, concomitant medication stratum and country, and baseline value as a covariate.|Paliperidone Extended Release (ER) Low Dose - Placebo on the Change Scores. Higher scores indicate worsening.|||0.5|-1.7|0.314
72486470|NCT00397033|144501257|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.5||0.071||95.0|-1.8|0.1|||ANCOVA|P-value is from an ANCOVA model with fixed-effects for treatment, concomitant medication stratum and country, and baseline value as a covariate.|Paliperidone Extended Release (ER) High Dose - Placebo on the Change Scores. Higher scores indicate worsening.|||0.1|-1.8|0.071
72486471|NCT00397033|144501257|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.5||0.099||95.0|-1.7|0.1|||ANCOVA|P-value is from an ANCOVA model with fixed-effects for treatment, concomitant medication stratum and country, and baseline value as a covariate.|Paliperidone Extended Release (ER) Low Dose - Placebo on the Change Scores. Higher scores indicate worsening.|||0.1|-1.7|0.099
72486472|NCT00397033|144501259|SUPERIORITY_OR_OTHER||LS Means Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.2|<|0.001||95.0|-0.9|-0.3|||ANCOVA|P-value is from an ANCOVA model with fixed-effects for treatment, concomitant medication stratum and country, and baseline value as a covariate.|Paliperidone Extended Release (ER) High Dose - Placebo on the Change Scores. Higher scores indicate worsening.|||-0.3|-0.9|<0.001
72486473|NCT00397033|144501259|SUPERIORITY_OR_OTHER||LS Means Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.2||0.083||95.0|-0.6|0.0|||ANCOVA|P-value is from an ANCOVA model with fixed-effects for treatment, concomitant medication stratum and country, and baseline value as a covariate.|Paliperidone Extended Release (ER) Low Dose - Placebo on the Change Scores. Higher scores indicate worsening.|||0.0|-0.6|0.083
72486474|NCT00397033|144501260|SUPERIORITY_OR_OTHER||LS Means Difference|-8.3|STANDARD_ERROR_OF_MEAN|2.8||0.003||95.0|-13.8|-2.9||The Hochberg step-up procedure was used to address multiplicity.|ANCOVA|P-value is from an ANCOVA model with fixed-effects for treatment, concomitant medication stratum and country, and baseline value as a covariate.|Paliperidone Extended Release (ER) High Dose - Placebo on the Change Scores. Higher scores indicate worsening.|One of the primary pairwise comparisons was paliperidone ER high dose vs. placebo. The Hochberg step-up procedure was used to address multiplicity. P-value for between treatment group comparisons is from an ANCOVA model with fixed-effects for treatment, concomitant medication stratum and country, and baseline value as a covariate.||-2.9|-13.8|0.003
72513456|NCT01580592|144557203|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3|STANDARD_DEVIATION|3.9|||TWO_SIDED|||||||||||||
72486475|NCT00397033|144501260|SUPERIORITY_OR_OTHER||LS Means Difference|-3.6|STANDARD_ERROR_OF_MEAN|2.7||0.187||95.0|-9.0|1.8||The Hochberg step-up procedure was used to address multiplicity.|ANCOVA|P-value is from an ANCOVA model with fixed-effects for treatment, concomitant medication stratum and country, and baseline value as a covariate.|Paliperidone Extended Release (ER) Low Dose - Placebo on the Change Scores. Higher scores indicate worsening.|One of the primary pairwise comparisons was paliperidone ER low dose vs. placebo. The Hochberg step-up procedure was used to address multiplicity. P-value for between treatment group comparisons is from an ANCOVA model with fixed-effects for treatment, concomitant medication stratum and country, and baseline value as a covariate.||1.8|-9.0|0.187
72486476|NCT00397033|144501261|SUPERIORITY_OR_OTHER||LS Means Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.2|<|0.001||95.0|-1.1|-0.4|||ANOVA|P-value is from an ANOVA model with fixed-effects for treatment, concomitant medication stratum and country.|Paliperidone Extended Release (ER) High Dose - Placebo on the Change Scores. Higher Scores indicate worsening.|||-0.4|-1.1|<0.001
72513457|NCT01580592|144557204|SUPERIORITY_OR_OTHER|||||||0.988|||||||Chi-squared|||||||0.988
72486477|NCT00397033|144501261|SUPERIORITY_OR_OTHER||LS Means Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.2||0.029||95.0|-0.7|0.0|||ANOVA|P-value is from an ANOVA model with fixed-effects for treatment, concomitant medication stratum and country.|Paliperidone Extended Release (ER) Low Dose - Placebo on the Change Scores. Higher scores indicate worsening.|||0.0|-0.7|0.029
72486478|NCT00397033|144501263|SUPERIORITY_OR_OTHER||LS Mean Difference|-6.8|STANDARD_ERROR_OF_MEAN|1.6|<|0.001||95.0|-9.9|-3.7|||ANCOVA|P-value is from an ANCOVA model with fixed-effects for treatment, concomitant medication stratum and country, and baseline value as a covariate.|Paliperidone Extended Release (ER) High Dose - Placebo on the Change Scores. Higher scores indicate worsening.|||-3.7|-9.9|<0.001
72513458|NCT03471767|144557205|SUPERIORITY|Multilevel modeling (MLM) was used to model daily reports of cigarettes smoked as a function of week, treatment (AXS-05 vs. bupropion), and the interaction between week and treatment. The contrast between the two treatment groups in change in smoking intensity from baseline to week 3 was estimated within the context of the model.|Mean Difference (Final Values)|-1.7|STANDARD_ERROR_OF_MEAN|0.54||0.05|TWO_SIDED|95.0|-2.75|-0.65||This was not adjusted for multiple comparisons, because the primary hypothesis was established a-priori.|t-test, 2 sided|||||-0.65|-2.75|0.05
72513459|NCT03471767|144557211|OTHER|||||||0.15|||||||t-test, 2 sided|||||||0.15
72402776|NCT01480076|144311693|SUPERIORITY_OR_OTHER|||||||0.5454|||||||mixed effect model|||Month 3, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D index scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.5454
72513460|NCT00678587|144557218|SUPERIORITY_OR_OTHER||Absolute difference in proportions|52.8|||<|0.0001|TWO_SIDED|95.0|43.2|62.4|||Cochran-Mantel-Haenszel|||||62.4|43.2|<0.0001
72513461|NCT00678587|144557219|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-5.9|||||TWO_SIDED|95.0|-15.1|3.3||||||||3.3|-15.1|
72513462|NCT00678587|144557220|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.0001
72513463|NCT01606761|144557242|SUPERIORITY_OR_OTHER||Percentage Difference|15.9|||<|0.001|TWO_SIDED|95.0|8.5|23.2|||Cochran-Mantel-Haenszel|||||23.2|8.5|< 0.001
72513464|NCT01606761|144557242|SUPERIORITY_OR_OTHER||Percentage Difference|21.0|||<|0.001|TWO_SIDED|95.0|13.6|28.5|||Cochran-Mantel-Haenszel|||||28.5|13.6|< 0.001
72513465|NCT01606761|144557243|SUPERIORITY_OR_OTHER||Least Square (LS) mean difference|-0.17|||<|0.001|TWO_SIDED|95.0|-0.251|-0.088|||ANCOVA|||||-0.088|-0.251|< 0.001
72513466|NCT01606761|144557243|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.194|||<|0.001|TWO_SIDED|95.0|-0.275|-0.112|||ANCOVA|||||-0.112|-0.275|< 0.001
72513467|NCT01606761|144557244|SUPERIORITY_OR_OTHER||Percentage Difference|12.0|||<|0.001|TWO_SIDED|95.0|6.4|17.7|||Cochran-Mantel-Haenszel|||||17.7|6.4|< 0.001
72513468|NCT01606761|144557244|SUPERIORITY_OR_OTHER||Percentage Difference|12.7|||<|0.001|TWO_SIDED|95.0|7.0|18.4|||Cochran-Mantel-Haenszel|||||18.4|7.0|< 0.001
72513469|NCT01606761|144557245|SUPERIORITY_OR_OTHER||Percentage Difference|11.0|||<|0.001|TWO_SIDED|95.0|5.5|16.5|||Cochran-Mantel-Haenszel|||||16.5|5.5|< 0.001
72513470|NCT01606761|144557245|SUPERIORITY_OR_OTHER||Percentage Difference|13.4|||<|0.001|TWO_SIDED|95.0|7.8|19.1|||Cochran-Mantel-Haenszel|||||19.1|7.8|< 0.001
72513471|NCT00926796|144557290|SUPERIORITY_OR_OTHER||Proportion of cured participants|100.0|||<|0.05|ONE_SIDED|95.0|98.53||||Exact binomial confidence limit|If the one-sided lower 95% confidence limit is greater than 95%, the null hypothesis of the microbiological efficacy estimate is \<95% is rejected.|When the lower 95% confidence limit is \>=95%, the alternative hypothesis is accepted (i.e., the microbiological cure estimate is significantly \>=95%).|The null hypothesis is that the microbiological efficacy estimate (proportion of participants who are cured) is \<95%.|||98.53|<0.05
72513472|NCT00926796|144557297|SUPERIORITY_OR_OTHER||Proportion of cured participants|99.5|||<|0.05|ONE_SIDED|95.0|97.64||||Exact bionomial confidence limit|If the one-sided lower 95% confidence limit is greater than 95%, the null hypothesis of the microbiological efficacy estimate is \<95% is rejected.|When the lower 95% confidence interval is above 95%, the alternative hypothesis is accepted (i.e., the microbiological cure estimate is significantly \>=95%).|The null hypothesis is that the microbiological efficacy estimate (proportion of participants who are cured) is \<95%.|||97.64|<0.05
72567863|NCT02749292|144667344|OTHER|Using a two-sided log-rank test with an alpha level of 0.05, a projected relapse risk of 15% in the superior group and 30% in the inferior group, and an estimated enrollment time of 36 months, it was determined that 200 patients were required to detect a significant difference with a power of 0.80. Due to the coronavirus disease 2019 (COVID-19) pandemic and the deleterious impact of rituximab on vaccination efficacy, the trial was concluded before reaching the target enrollment of 200.|Hazard Ratio (HR)|1.64||||0.42|TWO_SIDED|95.0|0.5|5.36|||Log Rank|||"The difference between the two treatment strategies was assessed using the log-rank test. P values of 0.05 were considered significant.~Null hypothesis: No difference in the ANCA and B-cell arm in the probability of relapses"||5.36|0.50|0.42
72513473|NCT01628016|144557299|OTHER||Mean Difference (Final Values)|3.98||||0.05|TWO_SIDED|95.0|||||Mixed Models Analysis|||||||.05
72513474|NCT01341652|144557301|OTHER|||||||0.97|||||||Mantel Haenszel|||||||0.97
72513475|NCT01341652|144557302|SUPERIORITY|||||||0.08|||||||Wilcoxon Rank Sum test|||||||.08
72513476|NCT01341652|144557304|OTHER||Hazard Ratio (HR)|1.6||||0.14|TWO_SIDED|95.0|0.9|2.8|||Regression, Cox|||||2.8|0.9|0.14
72513477|NCT03483506|144557321|OTHER||Geometric mean ratio|8.34|STANDARD_DEVIATION|50.5|||TWO_SIDED|90.0|5.88|11.82|||ANOVA||"Standard deviation is actually intra individual geometric coefficient of variation. BI 1467335 tab arm is the numerator, while BI 1467335 (C-14) iv arm is the denominator."|The statistical model used for the analysis of the primary PK endpoints was an ANOVA (analysis of variance) model on the logarithmic scale. The model included effects accounting for 'subject' and 'formulation' as sources of variation; 'subject' was considered as a random effect, whereas 'formulation' was considered as a fixed effect.||11.82|5.88|
72513478|NCT03483506|144557323|OTHER||Geometric mean ratio|62.14|STANDARD_DEVIATION|24.4|||TWO_SIDED|90.0|52.08|74.14|||ANOVA||"Standard deviation is actually intra individual geometric coefficient of variation. BI 1467335 tab arm is the numerator, while BI 1467335 (C-14) iv arm is the denominator."|The statistical model used for the analysis of the primary PK endpoints was an ANOVA (analysis of variance) model on the logarithmic scale. The model included effects accounting for 'subject' and 'formulation' as sources of variation; 'subject' was considered as a random effect, whereas 'formulation' was considered as a fixed effect.||74.14|52.08|
72513479|NCT00127062|144557362|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
72513480|NCT00127062|144557362|SUPERIORITY||||||>|0.05|||||||t-test, 2 sided|||||||>0.05
72513481|NCT03731364|144557371|SUPERIORITY|||||||0.276|||||||ANOVA|||||||0.276
72513482|NCT03731364|144557371|SUPERIORITY|||||||0.651|||||||ANOVA|||||||0.651
72513483|NCT03731364|144557371|SUPERIORITY|||||||0.556|||||||ANOVA|||||||0.556
72513484|NCT03731364|144557372|SUPERIORITY|||||||0.136|||||||Wilcoxon (Mann-Whitney)|||||||0.136
72513485|NCT03731364|144557372|SUPERIORITY|||||||0.649|||||||Wilcoxon (Mann-Whitney)|||||||0.649
72513486|NCT03731364|144557372|SUPERIORITY|||||||0.608|||||||Wilcoxon (Mann-Whitney)|||||||0.608
72513487|NCT03731364|144557373|SUPERIORITY||Odds Ratio (OR)|0.0||||0|TWO_SIDED|||||Not estimable|Regression, Logistic|Not estimable|Not estimable|Not estimable||||0
72513488|NCT03731364|144557373|SUPERIORITY||Odds Ratio (OR)|0.0||||0|TWO_SIDED|||||Not estimable|Regression, Logistic|Not estimable|Not estimable|Not estimable||||0
72513489|NCT03731364|144557373|SUPERIORITY||Odds Ratio (OR)|0.0||||0|TWO_SIDED|||||Not estimable|Regression, Logistic||Not estimable|Not estimable||||0
72402777|NCT01480076|144311693|SUPERIORITY_OR_OTHER||difference of LS means|0.05|STANDARD_ERROR_OF_MEAN|0.02||0.0516|TWO_SIDED||||||mixed effect model|||Month 3, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D index scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0516
72402778|NCT01480076|144311693|SUPERIORITY_OR_OTHER||difference of LS means|0.09|STANDARD_ERROR_OF_MEAN|0.04||0.0175|TWO_SIDED||||||mixed effect model|||Month 3, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D index scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0175
72402779|NCT01480076|144311693|SUPERIORITY_OR_OTHER|||||||0.0001|||||||mixed effect model|||Month 6, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D index scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0001
72402780|NCT01480076|144311693|SUPERIORITY_OR_OTHER|||||||0.9371|||||||mixed effect model|||Month 6, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D index scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.9371
72402781|NCT01480076|144311693|SUPERIORITY_OR_OTHER|||||||0.0056|||||||mixed effect model|||Month 6, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D index scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0056
72402782|NCT01480076|144311693|SUPERIORITY_OR_OTHER|||||||0.5475|||||||mixed effect model|||Month 6, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D index scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.5475
72402783|NCT01480076|144311693|SUPERIORITY_OR_OTHER||difference of LS means|0.05|STANDARD_ERROR_OF_MEAN|0.03||0.0699|TWO_SIDED||||||mixed effect model|||Month 6, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D index scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0699
72402784|NCT01480076|144311693|SUPERIORITY_OR_OTHER||difference of LS means|0.02|STANDARD_ERROR_OF_MEAN|0.05||0.587|TWO_SIDED||||||mixed effect model|||Month 6, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D index scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.5870
72486479|NCT00397033|144501263|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.8|STANDARD_ERROR_OF_MEAN|1.5||0.066||95.0|-5.8|0.2|||ANCOVA|P-value is from an ANCOVA model with fixed-effects for treatment, concomitant medication stratum and country, and baseline value as a covariate.|Paliperidone Extended Release (ER) Low Dose - Placebo on the Change Scores. Higher scores indicate worsening.|||0.2|-5.8|0.066
72486480|NCT02229539|144501268|SUPERIORITY_OR_OTHER_LEGACY|||||||0.02|||||||Wilcoxon rank-sum|||||||0.02
72486481|NCT02229539|144501268|SUPERIORITY_OR_OTHER_LEGACY|||||||0.004|||||||Wilcoxon rank-sum|||||||0.004
72486482|NCT00257166|144501283|SUPERIORITY_OR_OTHER_LEGACY||Least squares (LS) mean difference|-5.22|STANDARD_ERROR_OF_MEAN|1.48||0.0005|TWO_SIDED|95.0|-8.12|-2.31|||ANCOVA|||Change at Week 4: Mixed effects repeated measures Analysis of Covariance (ANCOVA) model with center and participant within center as random effects, treatment, visit and visit-by-treatment interaction as fixed effects and baseline score as a covariate was used for the analysis.||-2.31|-8.12|0.0005
72402785|NCT01480076|144311693|SUPERIORITY_OR_OTHER|||||||0.0245|||||||mixed effect model|||Month 9, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D index scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0245
72486483|NCT00257166|144501284|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-3.2545|STANDARD_ERROR_OF_MEAN|0.9422||0.0006|TWO_SIDED|95.0|-5.1045|-1.4046|||ANCOVA|||Change at Week 1: Mixed effects repeated measures ANCOVA model with center and participant within center as random effects, treatment, visit and visit-by-treatment interaction as fixed effects and baseline score as a covariate was used for the analysis.||-1.4046|-5.1045|0.0006
72513490|NCT03731364|144557374|SUPERIORITY|||||||0.306|||||||ANOVA|||||||0.306
72513491|NCT03731364|144557374|SUPERIORITY|||||||0.595|||||||ANOVA|||||||0.595
72513492|NCT03731364|144557374|SUPERIORITY|||||||0.242|||||||ANOVA|||||||0.242
72513493|NCT01934192|144557375|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.9|STANDARD_ERROR_OF_MEAN|7.02|||TWO_SIDED|95.0|-5.1|22.9||||||||22.9|-5.1|
72513494|NCT01934192|144557376|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.2|STANDARD_ERROR_OF_MEAN|4.35|||TWO_SIDED|95.0|-6.5|10.9||||||||10.9|-6.5|
72513495|NCT01934192|144557377|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.9|STANDARD_ERROR_OF_MEAN|7.03|||TWO_SIDED|95.0|-5.1|22.9||||||||22.9|-5.1|
72513496|NCT01934192|144557378|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.5|STANDARD_ERROR_OF_MEAN|6.74|||TWO_SIDED|95.0|-6.9|19.9||||||||19.9|-6.9|
72513497|NCT03095521|144557417|NON_INFERIORITY|two-sided 95% CIs estimation used to confirm non-inferior efficacy in primary endpoint. A non-inferiority conclusion was made relating to the primary parameter only.||||||0.028|TWO_SIDED|95.0|||||Fisher Exact|||Arm Angal, Arm Antiangin||||0.028
72513498|NCT03095521|144557420|SUPERIORITY|||||||0.482|||||||Wilcoxon (Mann-Whitney)|||||||0.482
72513499|NCT03095521|144557422|SUPERIORITY|||||||0.072|||||||t-test, 2 sided|||change from baseline, 2 groups||||0.072
72513500|NCT01536119|144557423|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.12||||0.27|TWO_SIDED|95.0|0.91|1.38|||Chi-squared|||"Power analysis was conducted to a 15 % increase in exclusive breastfeeding rates (from 52% to 67%) with 80% power and an alpha of 0.05. A 25% attrition rate waas added. 107 couples were needed per group. Intention to treat analysis conducted.~Exclusive breastfeeding at 12 weeks"||1.38|0.91|0.27
72513501|NCT01536119|144557424|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.19||||0.09||95.0|0.98|1.44|||Chi-squared|||||1.44|0.98|0.09
72513502|NCT01536119|144557425|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.06||||0.06||95.0|1.0|1.13|||Fisher Exact|||||1.13|1.00|0.06
72513503|NCT01536119|144557426|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.1||||0.02||95.0|1.01|1.19|||Chi-squared|||||1.19|1.01|0.02
72513504|NCT01536119|144557427|SUPERIORITY_OR_OTHER|||||||0.25||95.0|||||Wilcoxon (Mann-Whitney)|||Brief scale used||||0.25
72513505|NCT01536119|144557428|SUPERIORITY_OR_OTHER|||||||0.29||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.29
72513506|NCT01536119|144557429|SUPERIORITY_OR_OTHER|||||||0.12||95.0|||||t-test, 2 sided|||||||0.12
72513507|NCT01536119|144557430|SUPERIORITY_OR_OTHER|||||||0.21||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.21
72513508|NCT01536119|144557431|SUPERIORITY_OR_OTHER|||||||0.06||95.0|||||t-test, 2 sided|||||||0.06
72513509|NCT01536119|144557432|SUPERIORITY_OR_OTHER|||||||0.43||95.0|||||t-test, 2 sided|||||||0.43
72513510|NCT03829332|144557481|OTHER||Hazard Ratio (HR)|0.78||||0.00624|TWO_SIDED|95.0|0.64|0.95|||Stratified Log Rank|One-sided p-value based on log-rank test stratified by ECOG, region and baseline PD-L1 status.||Hazards ratio (HR) and 95% confidence interval (CI) were calculated using Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG performance status (0 versus 1), geographic region of the enrolling site (East Asia versus non-East Asia), and baseline PD-L1 Status (1% to 49% versus \>=50%).||0.95|0.64|0.00624
72513511|NCT03829332|144557482|OTHER||Hazard Ratio (HR)|1.1||||0.79744|TWO_SIDED|95.0|0.87|1.39|||Stratified Log Rank|One-sided p-value based on log-rank test stratified by ECOG, region, and baseline PD-L1 status.||HR and 95% CI were calculated using Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG performance status (0 versus 1), geographic region of the enrolling site (East Asia versus non-East Asia), and baseline PD-L1 Status (1% to 49% versus \>=50%).||1.39|0.87|0.79744
72513512|NCT03829332|144557483|OTHER||Percent Difference|12.8||||0.00037|TWO_SIDED|95.0|5.4|20.1|||Stratified Miettinen & Nurminen|One-sided p-value for testing. H0: difference in percent = 0 versus H1: difference in percent \> 0.||Percent difference and 95% CI were calculated using Miettinen \& Nurminen method stratified by ECOG performance status (0 versus 1), geographic region of the enrolling site (East Asia versus non-East Asia), and baseline PD-L1 Status (1% to 49% versus \>=50%).||20.1|5.4|0.00037
72513513|NCT03829332|144557486|OTHER|Difference in LS means and 95% CI were calculated using the Constrained longitudinal data analysis (cLDA) model with covariates for treatment by study visit interaction \& stratified by ECOG performance status (0 versus 1), geographic region of the enrolling site (East Asia versus non-East Asia), and baseline PD-L1 Status (1% to 49% versus \>=50%).|Difference in Least Square (LS) Means|-3.9||||0.0262|TWO_SIDED|95.0|-7.34|-0.47|||Constrained longitudinal data analysis|Two-sided p-value based on cLDA model with covariates for treatment by study visit interaction; stratified by ECOG, region \& baseline PDL-1.||||-0.47|-7.34|0.0262
72567864|NCT00251641|144667352|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|Pearson's chi-square test||The treatment comparison for this endpoint was carried at the 4.9% level of significance.||||<0.001
72567865|NCT00251641|144667353|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Multiplicity adjustment was provided using Hochberg test.|Chi-squared|Pearson's chi-square test||||||<0.001
72513514|NCT03829332|144557487|OTHER|Difference in LS means and 95% CI were calculated using the cLDA model with covariates for treatment by study visit interaction \& stratified by ECOG performance status (0 versus 1), geographic region of the enrolling site (East Asia versus non-East Asia), and baseline PD-L1 Status (1% to 49% versus \>=50%).|Difference in LS means|-4.5||||0.0461|TWO_SIDED|95.0|-8.91|-0.08||Two-sided p-value based on cLDA model with covariates for treatment by study visit interaction; stratified by ECOG, region \& baseline PDL-1.|cLDA model|||||-0.08|-8.91|0.0461
72513515|NCT03829332|144557488|OTHER|Difference in LS means and 95% CI were calculated using the cLDA model with covariates for treatment by study visit interaction \& stratified by ECOG performance status (0 versus 1), geographic region of the enrolling site (East Asia versus non-East Asia), and baseline PD-L1 Status (1% to 49% versus \>=50%).|Difference in LS means|-1.1||||0.5596|TWO_SIDED|95.0|-4.78|2.59|||cLDA model|Two-sided p-value based on cLDA model with covariates for treatment by study visit interaction; stratified by ECOG, region \& baseline PDL-1.||||2.59|-4.78|0.5596
72513516|NCT03829332|144557489|OTHER|Difference in LS means and 95% CI were calculated using the cLDA model with covariates for treatment by study visit interaction \& stratified by ECOG performance status (0 versus 1), geographic region of the enrolling site (East Asia versus non-East Asia), and baseline PD-L1 Status (1% to 49% versus \>=50%).|Difference in LS means|-0.88||||0.7088|TWO_SIDED|95.0|-5.49|3.74|||cLDA model|Two-sided p-value based on cLDA model with covariates for treatment by study visit interaction; stratified by ECOG, region \& baseline PDL-1.||||3.74|-5.49|0.7088
72513517|NCT03829332|144557490|OTHER|Difference in LS means and 95% CI were calculated using the cLDA model with covariates for treatment by study visit interaction \& stratified by ECOG performance status (0 versus 1), geographic region of the enrolling site (East Asia versus non-East Asia), and baseline PD-L1 Status (1% to 49% versus \>=50%).|Difference in LS means|-3.01||||0.1116|TWO_SIDED|95.0|-6.71|0.7|||cLDA model|Two-sided p-value based on cLDA model with covariates for treatment by study visit interaction; stratified by ECOG, region \& baseline PDL-1.||||0.70|-6.71|0.1116
72567866|NCT00251641|144667354|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Multiplicity adjustment was provided using the Hochberg test.|Chi-squared|Pearson's chi-square test||||||<0.001
72513518|NCT03829332|144557491|OTHER|HR and 95% CI were calculated using Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG performance status (0 versus 1), geographic region of the enrolling site (East Asia versus non-East Asia), and baseline PD-L1 Status (1% to 49% versus \>=50%).|Hazard Ratio (HR)|1.0||||0.9601|TWO_SIDED|95.0|0.75|1.33|||Stratified Log Rank|Two-sided p-value based on log-rank test stratified by ECOG, region and baseline PD-L1 status.||||1.33|0.75|0.9601
72513519|NCT03829332|144557492|OTHER|HR and 95% CI were calculated using Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG performance status (0 versus 1), geographic region of the enrolling site (East Asia versus non-East Asia), and baseline PD-L1 Status (1% to 49% versus \>=50%).|Hazard Ratio (HR)|0.61||||0.0079|TWO_SIDED|95.0|0.42|0.88|||Stratified Log Rank|Two-sided p-value based on log-rank test stratified by ECOG, region and baseline PD-L1 status.||||0.88|0.42|0.0079
72513520|NCT03829332|144557493|OTHER|HR and 95% CI were calculated using Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG performance status (0 versus 1), geographic region of the enrolling site (East Asia versus non-East Asia), and baseline PD-L1 Status (1% to 49% versus \>=50%).|Hazard Ratio (HR)|1.06||||0.7457|TWO_SIDED|95.0|0.73|1.56|||Stratified Log Rank|Two-sided p-value based on log-rank test stratified by ECOG, region and baseline PD-L1 status.||||1.56|0.73|0.7457
72513521|NCT03829332|144557494|OTHER|HR and 95% CI were calculated using Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG performance status (0 versus 1), geographic region of the enrolling site (East Asia versus non-East Asia), and baseline PD-L1 Status (1% to 49% versus \>=50%).|Hazard Ratio (HR)|1.04||||0.8122|TWO_SIDED|95.0|0.75|1.44|||Stratified Log Rank|Two-sided p-value based on log-rank test stratified by ECOG, region and baseline PD-L1 status.||||1.44|0.75|0.8122
72513522|NCT03829332|144557495|OTHER|HR and 95% CI were calculated using Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG performance status (0 versus 1), geographic region of the enrolling site (East Asia versus non-East Asia), and baseline PD-L1 Status (1% to 49% versus \>=50%).|Hazard Ratio (HR)|1.24||||0.148|TWO_SIDED|95.0|0.92|1.67|||Stratified Log Rank|Two-sided p-value based on log-rank test stratified by ECOG, region and baseline PD-L1 status.||||1.67|0.92|0.1480
72513523|NCT03829332|144557496|OTHER|HR and 95% CI were calculated using Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG performance status (0 versus 1), geographic region of the enrolling site (East Asia versus non-East Asia), and baseline PD-L1 Status (1% to 49% versus \>=50%).|Hazard Ratio (HR)|1.31||||0.4068|TWO_SIDED|95.0|0.7|2.46|||Stratified Log Rank|Two-sided p-value based on log-rank test stratified by ECOG, region and baseline PD-L1 status.||||2.46|0.70|0.4068
72513524|NCT02115113|144557552|SUPERIORITY_OR_OTHER||Mean Difference (Net)|5.24|STANDARD_ERROR_OF_MEAN|5.01||0.3013|TWO_SIDED|95.0|-4.86|15.34|||ANOVA|||||15.34|-4.86|0.3013
72513525|NCT02622724|144557555|SUPERIORITY|||||||0.8219|||||||Van Elteren hypothesis test|||A non-parametric analysis has been used as the data distribution was skewed. This involved a generalised Wilcoxon rank sum-based stratification test which assigns ranks within strata and compares two treatments within strata (Van Elteren hypothesis test).||||0.8219
72513526|NCT02622724|144557562|SUPERIORITY|||||||0.4678|||||||Van Elteren p-values|||Van Elteren hypothesis test was used as the distribution was non-normal and negatively skewed by patients who are assigned scores of zero in the event of death.||||0.4678
72513527|NCT02622724|144557567|SUPERIORITY||||||<|0.05|||||||ANCOVA|Analysis of covariance (ANCOVA) model using Type III sums of squares with Treatment, Severity, and Country fixed effect factors, Baseline as covariate||||||<0.05
72513528|NCT02622724|144557570|OTHER||Least Squares Mean|31.1|||>|0.05|TWO_SIDED|95.0|-37.7|99.9|||ANOVA|||Treatment effect was analysed using ANOVA parameter estimates (Least Squares Means and 95% Confidence Intervals) for the overall treatment difference for maximum distance walked on Day 180.||99.9|-37.7|>0.05
72513529|NCT02622724|144557584|OTHER||LS Means difference|0.0|||>|0.05|ONE_SIDED||||||ANCOVA|ANCOVA estimates (LS means and a 95 % CI for the treatment difference) were presented for all numeric biomarker variables.||IL -1ra - changes in levels from baseline to Day 14||||>0.05
72513530|NCT02622724|144557584|OTHER||LS Means difference|0.0|||>|0.05|ONE_SIDED||||||ANCOVA|ANCOVA estimates (LS means and a 95 % CI for the treatment difference) were presented for all numeric biomarker variables.||IL- 6 - changes in levels from baseline to Day 14||||>0.05
72513531|NCT02622724|144557584|OTHER||LS Means difference|0.0|||<|0.05|ONE_SIDED|95.0|||||ANCOVA|ANCOVA estimates (LS means and a 95% CI for the treatment difference) were presented for all numeric biomarker variables.||FGF basic - changes in levels from baseline to Day 14||||<0.05
72513532|NCT02622724|144557584|OTHER||LS Means difference|0.0|||<|0.05|ONE_SIDED||||||ANCOVA|ANCOVA estimates (LS means and a 95 % CI for the treatment difference) were presented for all numeric biomarker variables.||IP-10 - changes in levels from baseline to Day 14.||||<0.05
72567867|NCT00251641|144667355|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Multiplicity adjustment was provided using the Hochberg test.|Chi-squared|Pearson's chi-square test||||||<0.001
72513533|NCT02622724|144557584|OTHER||LS Means difference|0.0|||>|0.05|ONE_SIDED||||||ANCOVA|ANCOVA estimates (LS means and a 95 % CI for the treatment difference) were presented for all numeric biomarker variables.||TNF-α - changes in levels from baseline to Day 14||||>0.05
72513534|NCT02622724|144557585|OTHER||||||<|0.007||||||The p-value is not adjusted for multiple comparisons.|Chi-squared|||||||<0.007
72513535|NCT02622724|144557588|OTHER||Least Squares Mean|28.0|||>|0.05|TWO_SIDED|95.0|-54.0|110.1|||ANOVA|||Treatment effect was analysed using ANOVA parameter estimates (Least Squares Means and 95 % Confidence Intervals) for the overall treatment difference for maximun distance walked on Day 360.||110.1|-54|>0.05
72513536|NCT00798694|144557615|SUPERIORITY|||||||0.005|||||||Wilcoxon (Mann-Whitney)|||"Null Hypothesis: There is no significant difference in tear break-up time between the group New to Meds and the group Currently on Xalatan at two months."||||0.005
72513537|NCT01774344|144557624|SUPERIORITY||Hazard Ratio (HR)|0.624|||=|1.7e-05|TWO_SIDED|95.0|0.498|0.782|||Log Rank|||Hazard ratio for OS and 95% confidence interval was calculated for stratified IVRS by using Cox model, stratified by the geographic region: Asia or Rest of the World (ROW), ECOG-PS: 0 versus 1, AFP level, presence versus absence of extrahepatic disease and presence versus absence of macrovascular invasion. Kaplan-Meier (KM) estimated for OS and KM survival curves were presented for each treatment arm.||0.782|0.498|= 0.000017
72402786|NCT01480076|144311693|SUPERIORITY_OR_OTHER|||||||0.9926|||||||mixed effect model|||Month 9, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D index scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.9926
72486484|NCT00257166|144501284|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-3.5857|STANDARD_ERROR_OF_MEAN|1.4184||0.0117|TWO_SIDED|95.0|-6.3705|-0.8009|||ANCOVA|||Change at Week 2: Mixed effects repeated measures ANCOVA model with center and participant within center as random effects, treatment, visit and visit-by-treatment interaction as fixed effects and baseline score as a covariate was used for the analysis.||-0.8009|-6.3705|0.0117
72486485|NCT00257166|144501284|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-4.8665|STANDARD_ERROR_OF_MEAN|1.7154||0.0047|TWO_SIDED|95.0|-8.2345|-1.4985|||ANCOVA|||Change at Week 3: Mixed effects repeated measures ANCOVA model with center and participant within center as random effects, treatment, visit and visit-by-treatment interaction as fixed effects and baseline score as a covariate was used for the analysis.||-1.4985|-8.2345|0.0047
72486486|NCT00257166|144501285|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.3754|STANDARD_ERROR_OF_MEAN|0.0989||0.0002|TWO_SIDED|95.0|-0.5696|-0.1812|||ANCOVA|||Change at Week 1: Mixed effects repeated measures ANCOVA model with center and participant within center as random effects, treatment, visit and visit-by-treatment interaction as fixed effects and baseline score as a covariate was used for the analysis.||-0.1812|-0.5696|0.0002
72486487|NCT00257166|144501285|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.5596|STANDARD_ERROR_OF_MEAN|0.1355|<|0.0001|TWO_SIDED|95.0|-0.8256|-0.2936|||ANCOVA|||Change at Week 2: Mixed effects repeated measures ANCOVA model with center and participant within center as random effects, treatment, visit and visit-by-treatment interaction as fixed effects and baseline score as a covariate was used for the analysis.||-0.2936|-0.8256|<0.0001
72486488|NCT00257166|144501285|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.6798|STANDARD_ERROR_OF_MEAN|0.1643|<|0.0001|TWO_SIDED|95.0|-1.0024|-0.3572|||ANCOVA|||Change at Week 3: Mixed effects repeated measures ANCOVA model with center and participant within center as random effects, treatment, visit and visit-by-treatment interaction as fixed effects and baseline score as a covariate was used for the analysis.||-0.3572|-1.0024|<0.0001
72486489|NCT00257166|144501285|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.6884|STANDARD_ERROR_OF_MEAN|0.1761||0.0001|TWO_SIDED|95.0|-1.0342|-0.3426|||ANCOVA|||Change at Week 4: Mixed effects repeated measures ANCOVA model with center and participant within center as random effects, treatment, visit and visit-by-treatment interaction as fixed effects and baseline score as a covariate was used for the analysis.||-0.3426|-1.0342|0.0001
72486490|NCT00257166|144501286|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.76|STANDARD_ERROR_OF_MEAN|0.21||0.0004|TWO_SIDED|95.0|-1.18|-0.34|||ANCOVA|||Week 4: Mixed effects repeated measures ANCOVA model with center and participant within center as random effects, treatment, visit and visit-by-treatment interaction as fixed effects was used for the analysis.||-0.34|-1.18|0.0004
72486491|NCT04050670|144501295|NON_INFERIORITY|A priori estimates for the 90% CI geometric least square means ratios of AUC(0-∞) for the thigh versus abdomen injection sites were from 0.80 to 1.25|Ratio of geometric least squares mean|0.953|||||TWO_SIDED|90.0|0.935|0.97|||Linear mixed effects model|||||0.970|0.935|
72486492|NCT04050670|144501295|NON_INFERIORITY|A priori estimates for the 90% CI geometric least square means ratios of AUC(0-∞) for the upper arm versus abdomen injection sites were from 0.80 to 1.25.|Ratio of geometric least squares mean|0.99|||||TWO_SIDED|90.0|0.972|1.01|||Linear mixed effects model|||||1.01|0.972|
72486493|NCT04050670|144501296|NON_INFERIORITY|A priori estimates for the 90% CI geometric least square means ratios of Cmax for thigh versus abdomen injection sites were from 0.80 to 1.25.|Ratio of geometric least squares mean|0.862|||||TWO_SIDED|90.0|0.818|0.909|||Linear mixed effects model|||||0.909|0.818|
72486494|NCT04050670|144501296|NON_INFERIORITY|A priori estimates for the 90% CI geometric least square means ratios of Cmax for the upper arm versus abdomen injection sites were from 0.80 to 1.25.|Ratio of geometric least squares mean|0.921|||||TWO_SIDED|95.0|0.874|0.971|||Linear mixed effects model|||||0.971|0.874|
72567868|NCT04017754|144667363|EQUIVALENCE|A p-value \<0.05 was considered significant for at difference in frequency of low p-MBL level(\<500 ug/l) between groups.|Prevalence proportion ratio|1.79|||<|0.001|TWO_SIDED|95.0|1.34|2.38|||Chi-squared||The numerator is the risk of low p-MBL in the study sample with RPL patients and the denominator is the risk of low p-MBL in control group 1 of female blood donors.|Comparing the risk of low p-MBL level between RPL patients and MBL reference group. We hypothesized that more RPL patients had a low p-MBL level; thus, the null hypothesis was that no difference existed.||2.38|1.34|<0.001
72567869|NCT00534794|144667406|SUPERIORITY_OR_OTHER|||||||0.532||95.0|||||ANCOVA|||ITT (Intent to Treat)||||0.532
72486495|NCT00525044|144501344|OTHER||Mean Difference (Final Values)|-0.07|STANDARD_ERROR_OF_MEAN|0.028||0.0156|TWO_SIDED|95.0|-0.12|-0.01|||ANOVA||Treatment differences (Ambroxol- Placebo)|"Differences between the treatment groups with regard to the primary endpoint SPIDnorm was tested using an analysis of variance (ANOVA) including treatment and centre as fix effects.~Treatment differences were estimated by reference to the adjusted least squares mean differences and the corresponding 95 % confidence intervals."||-0.01|-0.12|0.0156
72486496|NCT00525044|144501345|OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.1||0.128|TWO_SIDED|95.0|-0.4|0.0|||ANCOVA||Treatment differences (Ambroxol- Placebo)|"Analysis at 30 min:~analysis of covariance (ANCOVA) including treatment and centre as fix effects and baseline as covariable are presented. Treatment differences are estimated by reference to the adjusted least squares mean differences and the corresponding 95 % confidence intervals."||0|-0.4|0.1280
72486497|NCT00525044|144501345|OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.11||0.0417|TWO_SIDED|95.0|-0.4|0.0|||ANCOVA||Treatment differences (Ambroxol- Placebo)|"Analysis at 60 min:~analysis of covariance (ANCOVA) including treatment and centre as fix effects and baseline as covariable are presented. Treatment differences are estimated by reference to the adjusted least squares mean differences and the corresponding 95 % confidence intervals."||0.0|-0.4|0.0417
72567870|NCT00534794|144667407|SUPERIORITY_OR_OTHER|||||||0.927||95.0|||||Student's t-test|||ITT (Intent to Treat)||||0.927
72576971|NCT00261443|144680730|SUPERIORITY_OR_OTHER_LEGACY|||||||0.868||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Change from Baseline in Hemoglobin at Week 52 (LOCF)||||0.868
72402787|NCT01480076|144311693|SUPERIORITY_OR_OTHER|||||||0.0027|||||||mixed effect model|||Month 9, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D index scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0027
72513538|NCT01774344|144557624|SUPERIORITY||Hazard Ratio (HR)|0.66|||=|0.000149|TWO_SIDED|95.0|0.527|0.828|||Log Rank|||Hazard ratio for OS and 95% confidence interval was calculated for stratified RAVE (Sensitivity) by using Cox model, stratified by the geographic region: Asia or Rest of the World (ROW), ECOG-PS: 0 versus 1, AFP level, presence versus absence of extrahepatic disease and presence versus absence of macrovascular invasion. Kaplan-Meier (KM) estimated for OS and KM survival curves were presented for each treatment arm.||0.828|0.527|= 0.000149
72513539|NCT01774344|144557624|SUPERIORITY||Hazard Ratio (HR)|0.674|||=|0.000107|TWO_SIDED|95.0|0.546|0.831|||Log Rank|||Hazard ratio for OS and 95% confidence interval was calculated for unstratified (sensitivity) by using Cox model, stratified by the geographic region: Asia or Rest of the World (ROW), ECOG-PS: 0 versus 1, AFP level, presence versus absence of extrahepatic disease and presence versus absence of macrovascular invasion. Kaplan-Meier (KM) estimated for OS and KM survival curves were presented for each treatment arm.||0.831|0.546|= 0.000107
72513540|NCT01774344|144557625|SUPERIORITY||Hazard Ratio (HR)|0.439|||<|1e-06|TWO_SIDED|95.0|0.355|0.542|||Log Rank|||Hazard ratio and its 95% CI was based on stratified (IVRS) Cox Regression Model. One-sided p-value was calculated from log rank test and 95% CIs was computed by using Kaplan-Meier estimates.||0.542|0.355|< 0.000001
72513541|NCT01774344|144557625|SUPERIORITY||Hazard Ratio (HR)|0.471|||<|1e-06|TWO_SIDED|95.0|0.388|0.572|||Log Rank|||Hazard ratio and its 95% CI was based on unstratified (IVRS) Cox Regression Model. One-sided p-value was calculated from log rank test and 95% CIs was computed by using Kaplan-Meier estimates.||0.572|0.388|< 0.000001
72513542|NCT01774344|144557625|SUPERIORITY||Hazard Ratio (HR)|0.412|||<|1e-06|TWO_SIDED|95.0|0.334|0.509|||Log Rank|||Hazard ratio and its 95% CI was based on stratified (IVRS) Cox Regression Model. One-sided p-value was calculated from log rank test and 95% CIs was computed by using Kaplan-Meier estimates.||0.509|0.334|< 0.000001
72513543|NCT01774344|144557625|SUPERIORITY||Hazard Ratio (HR)|0.444|||<|1e-06|TWO_SIDED|95.0|0.365|0.539|||Log Rank|||Hazard ratio and its 95% CI was based on unstratified (IVRS) Cox Regression Model. One-sided p-value was calculated from log rank test and 95% CIs was computed by using Kaplan-Meier estimates.||0.539|0.365|< 0.000001
72567871|NCT03456960|144667426|EQUIVALENCE|The difference in the least square means (LSM) between study medications (TAK-438ASA tablet - concomitant administration of TAK-438 tablet and aspirin enteric-coated tablet) and the two-sided 90 percent (%) confidence interval (CI) were provided using a crossover analysis of variance (ANOVA) model. The ANOVA model included a log-transformed (natural log) analysis variable as the dependent variable, and study medication, sequence, and period as independent variables.|LSM Difference|0.0059|||||TWO_SIDED|90.0|-0.034|0.0458||||||||0.0458|-0.0340|
72513544|NCT01774344|144557626|SUPERIORITY||Hazard Ratio (HR)|0.453|||<|1e-06|TWO_SIDED|95.0|0.369|0.555|||Log Rank|||Hazard ratio and its 95% CI was based on stratified (IVRS) Cox Regression Model. One-sided p-value was calculated from log rank test and 95% CIs was computed by using Cox Regression Model.||0.555|0.369|< 0.000001
72513545|NCT01774344|144557626|SUPERIORITY||Hazard Ratio (HR)|0.48|||<|1e-06|TWO_SIDED|95.0|0.397|0.58|||Log Rank|||Hazard ratio and its 95% CI was based on unstratified Cox Regression Model. One-sided p-value was calculated from log rank test and 95% CIs was computed by using Cox Regression Model.||0.580|0.397|< 0.000001
72513546|NCT01774344|144557626|SUPERIORITY||Hazard Ratio (HR)|0.425|||<|1e-06|TWO_SIDED|95.0|0.347|0.522|||Log Rank|||Hazard ratio and its 95% CI was based on stratified (IVRS) Cox Regression Model. One-sided p-value was calculated from log rank test and 95% CIs was computed by using Cox Regression Model.||0.522|0.347|< 0.000001
72513547|NCT01774344|144557626|SUPERIORITY||Hazard Ratio (HR)|0.454|||<|1e-06|TWO_SIDED|95.0|0.376|0.548|||Log Rank|||Hazard ratio and its 95% CI was based on unstratified Cox Regression Model. One-sided p-value was calculated from log rank test and 95% CIs was computed by using Cox Regression Model.||0.548|0.376|< 0.000001
72513548|NCT01774344|144557627|SUPERIORITY||Difference|-6.88|||=|0.00365|TWO_SIDED|95.0|-11.13|-2.63|||Cochran-Mantel-Haenszel|||Comparison of treatments were calculated.||-2.63|-11.13|= 0.003650
72513549|NCT01774344|144557627|SUPERIORITY||Difference|-4.15|||=|0.019991|TWO_SIDED|95.0|-7.55|-0.75|||Cochran-Mantel-Haenszel|||Comparison of treatments were calculated.||-0.75|-7.55|= 0.019991
72567872|NCT03456960|144667427|EQUIVALENCE|The difference in the LSM between study medications (TAK-438ASA tablet - concomitant administration of TAK-438 tablet and aspirin enteric-coated tablet) and the two-sided 90% CI were provided using a crossover ANOVA model. The ANOVA model included a log-transformed (natural log) analysis variable as the dependent variable, and study medication, sequence, and period as independent variables.|LSM Difference|0.0508|||||TWO_SIDED|90.0|-0.0079|0.1096||||||||0.1096|-0.0079|
72513550|NCT01774344|144557628|SUPERIORITY||Difference|-29.31|||<|1e-06|TWO_SIDED|95.0|-37.52|-21.11|||Cochran-Mantel-Haenszel|||Comparison of treatments were calculated.||-21.11|-37.52|< 0.000001
72513551|NCT01774344|144557628|SUPERIORITY||Difference|-31.39|||<|1e-06|TWO_SIDED|95.0|-39.57|-23.22|||Cochran-Mantel-Haenszel|||Comparison of treatments were calculated.||-23.22|-39.57|< 0.000001
72576972|NCT00261443|144680730|SUPERIORITY_OR_OTHER_LEGACY|||||||0.299||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Lowest Change Value in Hemoglobin During Phase 3||||0.299
72513552|NCT03546413|144557630|SUPERIORITY||||||<|0.001||||||This is the calculated p-value|Regression, Logistic|||Test for equivalence between the groups||||<0.001
72513553|NCT03546413|144557631|SUPERIORITY|A logistic regression model was used with a fixed effect comparing the Avoidance and Consumption cohorts and a random effect to account for siblings who are in the same family unit.||||||0.055|||||||Regression, Logistic|||Test for equivalence between the groups||||0.055
72513554|NCT03546413|144557632|SUPERIORITY||||||<|0.001||||||This is the calculated p-value|Wilcoxon (Mann-Whitney)|||||||<0.001
72513555|NCT03546413|144557632|SUPERIORITY|A linear regression model was used on the log of the peanut consumption with a fixed effect comparing the Avoidance and Consumption cohorts and a random effect to account for siblings who are in the same family unit.|||||<|0.001||||||This is the calculated p-value|Regression, Linear|||||||<0.001
72402788|NCT01480076|144311693|SUPERIORITY_OR_OTHER|||||||0.6368|||||||mixed effect model|||Month 9, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D index scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.6368
72567873|NCT03456960|144667428|EQUIVALENCE|Pilot Study 1: The difference in the LSM between study medications (TAK-438ASA tablet - concomitant administration of TAK-438 tablet and aspirin enteric-coated tablet) and the two-sided 90% CI were provided using a crossover ANOVA model. The ANOVA model included a log-transformed (natural log) analysis variable as the dependent variable, and study medication, sequence, and period as independent variables.|LSM Difference|0.0546|||||TWO_SIDED|90.0|-0.0941|0.2034||||||||0.2034|-0.0941|
72567874|NCT03456960|144667428|EQUIVALENCE|Pivotal Study 1: The difference in the LSM between study medications (TAK-438ASA tablet - concomitant administration of TAK-438 tablet and aspirin enteric-coated tablet) and the two-sided 90% CI were provided using a crossover ANOVA model. The ANOVA model will include a log-transformed (natural log) analysis variable as the dependent variable, and study medication, sequence, and period as independent variables.|LSM Difference|0.0912|||||TWO_SIDED|90.0|0.0399|0.1424||||||||0.1424|0.0399|
72567875|NCT03456960|144667429|EQUIVALENCE|Pilot Study 1: The difference in the LSM between study medications (TAK-438ASA tablet - concomitant administration of TAK-438 tablet and aspirin enteric-coated tablet) and the two-sided 90% CI were provided using a crossover ANOVA model. The ANOVA model included a log-transformed (natural log) analysis variable as the dependent variable, and study medication, sequence, and period as independent variables.|LSM Difference|0.0916|||||TWO_SIDED|90.0|-0.133|0.3162||||||||0.3162|-0.1330|
72567876|NCT03456960|144667429|EQUIVALENCE|Pivotal Study 1: The difference in the LSM between study medications (TAK-438ASA tablet - concomitant administration of TAK-438 tablet and aspirin enteric-coated tablet) and the two-sided 90% CI were provided using a crossover ANOVA model. The ANOVA model included a log-transformed (natural log) analysis variable as the dependent variable, and study medication, sequence, and period as independent variables.|LSM Difference|0.2293|||||TWO_SIDED|90.0|0.1519|0.3068||||||||0.3068|0.1519|
72567877|NCT03456960|144667430|EQUIVALENCE|The difference in the LSM between study medications (TAK-438ASA tablet - concomitant administration of TAK-438 tablet and aspirin enteric-coated tablet) and the two-sided 90% CI were provided using a crossover ANOVA model. The ANOVA model included a log-transformed (natural log) analysis variable as the dependent variable, and study medication, sequence, and period as independent variables.|LSM Difference|0.01|||||TWO_SIDED|90.0|-0.0299|0.05||||||||0.0500|-0.0299|
72567878|NCT03456960|144667431|EQUIVALENCE|The difference in the LSM between study medications (TAK-438ASA tablet - concomitant administration of TAK-438 tablet and aspirin enteric-coated tablet) and the two-sided 90% CI were provided using a crossover ANOVA model. The ANOVA model included a log-transformed (natural log) analysis variable as the dependent variable, and study medication, sequence, and period as independent variables.|LSM Difference|-0.0281|||||TWO_SIDED|90.0|-0.1662|0.11||||||||0.1100|-0.1662|
72567879|NCT03456960|144667432|EQUIVALENCE|The difference in the LSM between study medications (TAK-438ASA tablet - concomitant administration of TAK-438 tablet and aspirin enteric-coated tablet) and the two-sided 90% CI were provided using a crossover ANOVA model. The ANOVA model included a log-transformed (natural log) analysis variable as the dependent variable, and study medication, sequence, and period as independent variables.|LSM Difference|-0.015|||||TWO_SIDED|90.0|-0.0448|0.0149||||||||0.0149|-0.0448|
72567880|NCT03456960|144667433|EQUIVALENCE|The difference in the LSM between study medications (TAK-438ASA tablet - concomitant administration of TAK-438 tablet and aspirin enteric-coated tablet) and the two-sided 90% CI were provided using a crossover ANOVA model. The ANOVA model included a log-transformed (natural log) analysis variable as the dependent variable, and study medication, sequence, and period as independent variables.|LSM Difference|-0.0195|||||TWO_SIDED|90.0|-0.0676|0.0286||||||||0.0286|-0.0676|
72567881|NCT03456960|144667434|EQUIVALENCE|Pilot Study 1: The difference in the LSM between study medications (TAK-438ASA tablet - concomitant administration of TAK-438 tablet and aspirin enteric-coated tablet) and the two-sided 90% CI were provided using a crossover ANOVA model. The ANOVA model included a log-transformed (natural log) analysis variable as the dependent variable, and study medication, sequence, and period as independent variables.|LSM Difference|0.0547|||||TWO_SIDED|90.0|-0.0937|0.2032||||||||0.2032|-0.0937|
72567882|NCT03456960|144667434|EQUIVALENCE|Pivotal Study 1: The difference in the LSM between study medications (TAK-438ASA tablet - concomitant administration of TAK-438 tablet and aspirin enteric-coated tablet) and the two-sided 90% CI were provided using a crossover ANOVA model. The ANOVA model included a log-transformed (natural log) analysis variable as the dependent variable, and study medication, sequence, and period as independent variables.|LSM Difference|0.0654|||||TWO_SIDED|90.0|0.0141|0.1167||||||||0.1167|0.0141|
72402789|NCT01480076|144311693|SUPERIORITY_OR_OTHER||difference of LS means|0.03|STANDARD_ERROR_OF_MEAN|0.03||0.3358|TWO_SIDED||||||mixed effect model|||Month 9, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D index scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.3358
72486498|NCT00525044|144501345|OTHER||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.13||0.0054|TWO_SIDED|95.0|-0.6|-0.1|||ANCOVA||Treatment differences (Ambroxol- Placebo|"Analysis at 120 min:~analysis of covariance (ANCOVA) including treatment and centre as fix effects and baseline as covariable are presented. Treatment differences are estimated by reference to the adjusted least squares mean differences and the corresponding 95 % confidence intervals."||-0.1|-0.6|0.0054
72567883|NCT03456960|144667435|EQUIVALENCE|Pilot Study 1: The difference in the LSM between study medications (TAK-438ASA tablet - concomitant administration of TAK-438 tablet and aspirin enteric-coated tablet) and the two-sided 90% CI were provided using a crossover ANOVA model. The ANOVA model included a log-transformed (natural log) analysis variable as the dependent variable, and study medication, sequence, and period as independent variables.|LSM Difference|-0.146|||||TWO_SIDED|90.0|-0.2478|-0.0443||||||||-0.0443|-0.2478|
72576973|NCT00261443|144680731|SUPERIORITY_OR_OTHER_LEGACY|||||||0.187||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Baseline Hematocrit||||0.187
72567884|NCT03456960|144667435|EQUIVALENCE|Pivotal Study 1: The difference in the LSM between study medications (TAK-438ASA tablet - concomitant administration of TAK-438 tablet and aspirin enteric-coated tablet) and the two-sided 90% CI were provided using a crossover ANOVA model. The ANOVA model included a log-transformed (natural log) analysis variable as the dependent variable, and study medication, sequence, and period as independent variables.|LSM Difference|-0.1674|||||TWO_SIDED|90.0|-0.2084|-0.1264||||||||-0.1264|-0.2084|
72513556|NCT03546413|144557632|SUPERIORITY|A linear regression model was used on the log of the peanut consumption with a fixed effect comparing the Avoidance and Consumption cohorts and a random effect to account for siblings who are in the same family unit.||||||0.939|||||||Regression, Linear|||||||0.939
72513557|NCT03546413|144557632|SUPERIORITY|A linear regression model was used on the log of the peanut consumption with a fixed effect comparing the Avoidance and Consumption cohorts and a random effect to account for parents who are in the same family unit.||||||0.002|||||||Regression, Linear|||||||0.002
72486499|NCT00525044|144501345|OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.13||0.0201|TWO_SIDED|95.0|-0.6|0.0|||ANCOVA||Treatment differences (Ambroxol- Placebo|"Analysis at 180 min:~analysis of covariance (ANCOVA) including treatment and centre as fix effects and baseline as covariable are presented. Treatment differences are estimated by reference to the adjusted least squares mean differences and the corresponding 95 % confidence intervals."||0.0|-0.6|0.0201
72486500|NCT00525044|144501346|OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.1||0.128|TWO_SIDED|95.0|-0.4|0.0|||ANCOVA||Treatment differences (Ambroxol- Placebo)|"Analysis at 30 min:~analysis of covariance (ANCOVA) including treatment and centre as fix effects and baseline as covariable are presented. Treatment differences are estimated by reference to the adjusted least squares mean differences and the corresponding 95 % confidence intervals."||0.0|-0.4|0.1280
72486501|NCT00525044|144501346|OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.11||0.0417|TWO_SIDED|95.0|-0.4|0.0|||ANCOVA||Treatment differences (Ambroxol- Placebo|"Analysis at 60 min:~analysis of covariance (ANCOVA) including treatment and centre as fix effects and baseline as covariable are presented. Treatment differences are estimated by reference to the adjusted least squares mean differences and the corresponding 95 % confidence intervals."||0.0|-0.4|0.0417
72486502|NCT00525044|144501346|OTHER||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.13||0.0054|TWO_SIDED|95.0|-0.6|-0.1|||ANCOVA||Treatment differences (Ambroxol- Placebo|"Analysis at 120 min:~analysis of covariance (ANCOVA) including treatment and centre as fix effects and baseline as covariable are presented. Treatment differences are estimated by reference to the adjusted least squares mean differences and the corresponding 95 % confidence intervals."||-0.1|-0.6|0.0054
72486503|NCT00525044|144501346|OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.13||0.0201|TWO_SIDED|95.0|-0.6|0.0|||ANCOVA||Treatment differences (Ambroxol- Placebo|"Analysis at 180 min:~analysis of covariance (ANCOVA) including treatment and centre as fix effects and baseline as covariable are presented. Treatment differences are estimated by reference to the adjusted least squares mean differences and the corresponding 95 % confidence intervals."||0.0|-0.6|0.0201
72486504|NCT00525044|144501347|OTHER|||||||0.9939|||||||Mantel Haenszel|||"Analysis at day 1:~P-value was calculated by the Cochran-Mantel-Haenszel test adjusting for center."||||0.9939
72486505|NCT00525044|144501347|OTHER|||||||0.5552|||||||Mantel Haenszel|||"Analysis at day 2:~P-value was calculated by the Cochran-Mantel-Haenszel test adjusting for center."||||0.5552
72486506|NCT00525044|144501348|OTHER|||||||0.0343|||||||Mantel Haenszel|||"Analysis at day 1:~P-value was calculated by the Cochran-Mantel-Haenszel test adjusting for center."||||0.0343
72486507|NCT00525044|144501348|OTHER|||||||0.0119|||||||Mantel Haenszel|||"Analysis at day 2:~P-value was calculated by the Cochran-Mantel-Haenszel test adjusting for center."||||0.0119
72486508|NCT01301456|144501451|SUPERIORITY_OR_OTHER||Least square (LS) mean|-21.16|STANDARD_ERROR_OF_MEAN|16.766||0.219|TWO_SIDED|80.0|-43.26|0.93|||Mixed meal tolerance test|||Day 30||0.93|-43.26|0.219
72486509|NCT01301456|144501451|SUPERIORITY_OR_OTHER||LS mean|-34.18|STANDARD_ERROR_OF_MEAN|15.189||0.034|TWO_SIDED|80.0|-54.2|-14.16|||Mixed meal tolerance test|||Day 30||-14.16|-54.20|0.034
72486510|NCT01301456|144501451|SUPERIORITY_OR_OTHER||LS mean|-33.67|STANDARD_ERROR_OF_MEAN|15.806||0.044|TWO_SIDED|80.0|-54.5|-12.84|||Mixed meal tolerance test|||Day 30||-12.84|-54.50|0.044
72513558|NCT03546413|144557633|SUPERIORITY|||||||0.131|||||||Wilcoxon (Mann-Whitney)|||||||0.131
72486511|NCT01301456|144501451|SUPERIORITY_OR_OTHER||LS mean|-2.93|STANDARD_ERROR_OF_MEAN|16.111||0.857|TWO_SIDED|80.0|-24.16|18.31|||Mixed meal tolerance test|||Day 30||18.31|-24.16|0.857
72486512|NCT01301456|144501452|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.21|STANDARD_ERROR_OF_MEAN|0.251||0.419|TWO_SIDED|80.0|-0.54|0.12|||Mixed meal tolerance test|||Day 29: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.||0.12|-0.54|0.419
72486513|NCT01301456|144501452|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.41|STANDARD_ERROR_OF_MEAN|0.224||0.077|TWO_SIDED|80.0|-0.71|-0.12|||Mixed meal tolerance test|||Day 29: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.||-0.12|-0.71|0.077
72486514|NCT01301456|144501452|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.34|STANDARD_ERROR_OF_MEAN|0.23||0.147|TWO_SIDED|80.0|-0.65|-0.04|||Mixed meal tolerance test|||Day 29: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.||-0.04|-0.65|0.147
72486515|NCT01301456|144501452|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.43|STANDARD_ERROR_OF_MEAN|0.244||0.086|TWO_SIDED|80.0|-0.76|-0.11|||Mixed meal tolerance test|||Day 29: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.||-0.11|-0.76|0.086
72567885|NCT03456960|144667436|EQUIVALENCE|Pilot Study 1: The difference in the LSM between study medications (TAK-438ASA tablet - concomitant administration of TAK-438 tablet and aspirin enteric-coated tablet) and the two-sided 90% CI were provided using a crossover ANOVA model. The ANOVA model included a log-transformed (natural log) analysis variable as the dependent variable, and study medication, sequence, and period as independent variables.|LSM Difference|-0.1193|||||TWO_SIDED|90.0|-0.2179|-0.0206||||||||-0.0206|-0.2179|
72513559|NCT03546413|144557633|SUPERIORITY|A linear regression model was used on the log of peanut skin prick test with a fixed effect comparing the Avoidance and Consumption cohorts and a random effect to account for siblings who are in the same family unit.||||||0.208|||||||Regression, Linear|||||||0.208
72567886|NCT03456960|144667436|EQUIVALENCE|Pivotal Study 1: The difference in the LSM between study medications (TAK-438ASA tablet - concomitant administration of TAK-438 tablet and aspirin enteric-coated tablet) and the two-sided 90% CI were provided using a crossover ANOVA model. The ANOVA model included a log-transformed (natural log) analysis variable as the dependent variable, and study medication, sequence, and period as independent variables.|LSM Difference|-0.1366|||||TWO_SIDED|90.0|-0.173|-0.1002||||||||-0.1002|-0.1730|
72486516|NCT01301456|144501454|SUPERIORITY_OR_OTHER||LS Mean Difference|4.11|STANDARD_ERROR_OF_MEAN|9.326||0.663|TWO_SIDED|80.0|-8.16|16.37|||Mixed meal tolerance test|||Day 8: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.||16.37|-8.16|0.663
72486517|NCT01301456|144501454|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.89|STANDARD_ERROR_OF_MEAN|8.472||0.825|TWO_SIDED|80.0|-13.03|9.25|||mixed meal tolerance test|||Day 8: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.||9.25|-13.03|0.825
72486518|NCT01301456|144501454|SUPERIORITY_OR_OTHER||LS Mean Difference|1.36|STANDARD_ERROR_OF_MEAN|8.791||0.878|TWO_SIDED|80.0|-10.2|12.92|||Mixed meal tolerance test|||Day 8: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.||12.92|-10.20|0.878
72513560|NCT03546413|144557633|SUPERIORITY|A linear regression model was used on the log of peanut skin prick with a fixed effect comparing the Avoidance and Consumption cohorts and a random effect to account for siblings who are in the same family unit.||||||0.587|||||||Regression, Linear|||||||0.587
72513561|NCT03546413|144557633|SUPERIORITY|A linear regression model was used on the log of peanut skin prick with a fixed effect comparing the Avoidance and Consumption cohorts and a random effect to account for parents who are in the same family unit.||||||0.268|||||||Regression, Linear|||||||0.268
72513562|NCT03546413|144557634|SUPERIORITY|||||||0.985|||||||Wilcoxon (Mann-Whitney)|||||||0.985
72513563|NCT03546413|144557634|SUPERIORITY|A linear regression model was used on the log of peanut specific IgE with a fixed effect comparing the Avoidance and Consumption cohorts and a random effect to account for siblings who are in the same family unit.||||||0.371|||||||Regression, Linear|||||||0.371
72513564|NCT03546413|144557634|SUPERIORITY|A linear regression model was used on the log of peanut specific IgE with a fixed effect comparing the Avoidance and Consumption cohorts and a random effect to account for siblings who are in the same family unit.||||||0.483|||||||Regression, Linear|||||||0.483
72486519|NCT01301456|144501454|SUPERIORITY_OR_OTHER||LS Mean Difference|0.72|STANDARD_ERROR_OF_MEAN|8.829||0.936|TWO_SIDED|80.0|-10.89|12.33|||Mixed meal tolerance test|||Day 8: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.||12.33|-10.89|0.936
72486520|NCT01301456|144501454|SUPERIORITY_OR_OTHER||LS Mean Difference|0.68|STANDARD_ERROR_OF_MEAN|13.037||0.959|TWO_SIDED|80.0|-16.46|17.82|||Mixed meal tolerance test|||Day 15: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.||17.82|-16.46|0.959
72513565|NCT03546413|144557634|SUPERIORITY|A linear regression model was used on the log of peanut specific IgE with a fixed effect comparing the Avoidance and Consumption cohorts and a random effect to account for parents who are in the same family unit.||||||0.643|||||||Regression, Linear|||||||0.643
72513566|NCT03546413|144557635|SUPERIORITY|||||||0.225|||||||Wilcoxon (Mann-Whitney)|||||||0.225
72513567|NCT03546413|144557635|SUPERIORITY|A linear regression model was used on the log of SCORAD with a fixed effect comparing the Avoidance and Consumption cohorts and a random effect to account for siblings who are in the same family unit.||||||0.857|||||||Regression, Linear|||||||0.857
72513568|NCT03546413|144557635|SUPERIORITY|A linear regression model was used on the log of SCORAD with a fixed effect comparing the Avoidance and Consumption cohorts and a random effect to account for siblings who are in the same family unit.||||||0.87|||||||Regression, Linear|||||||0.870
72513569|NCT03546413|144557636|SUPERIORITY|||||||0.658|||||||Regression, Logistic|||||||0.658
72513570|NCT03546413|144557636|SUPERIORITY|A logistic regression model was used with a fixed effect comparing the Avoidance and Consumption cohorts and a random effect to account for siblings who are in the same family unit.||||||0.1|||||||Regression, Logistic|||||||0.100
72513571|NCT03546413|144557636|SUPERIORITY|A logistic regression model was used with a fixed effect comparing the Avoidance and Consumption cohorts and a random effect to account for siblings who are in the same family unit.||||||0.502|||||||Regression, Linear|||||||0.502
72513572|NCT03546413|144557636|SUPERIORITY|A logistic regression model was used with a fixed effect comparing the Avoidance and Consumption cohorts and a random effect to account for parents who are in the same family unit.||||||0.397|||||||Regression, Linear|||||||0.397
72513573|NCT03546413|144557637|SUPERIORITY|||||||0.659|||||||Regression, Logistic|||||||0.659
72576974|NCT00261443|144680731|SUPERIORITY_OR_OTHER_LEGACY|||||||0.377||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Change from Baseline in Hematocrit During Week 52 (LOCF)||||0.377
72576975|NCT00261443|144680731|SUPERIORITY_OR_OTHER_LEGACY|||||||0.494||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Lowest Value of Change in Hematocrit During Phase 3||||0.494
72513574|NCT03546413|144557637|SUPERIORITY|A logistic regression model was used with a fixed effect comparing the Avoidance and Consumption cohorts and a random effect to account for siblings who are in the same family unit.||||||0.26|||||||Regression, Logistic|||||||0.260
72513575|NCT03546413|144557637|SUPERIORITY|A logistic regression model was used with a fixed effect comparing the Avoidance and Consumption cohorts and a random effect to account for siblings who are in the same family unit.||||||0.075|||||||Regression, Linear|||||||0.075
72513576|NCT03546413|144557637|SUPERIORITY|A logistic regression model was used with a fixed effect comparing the Avoidance and Consumption cohorts and a random effect to account for parents who are in the same family unit.||||||0.192|||||||Regression, Logistic|||||||0.192
72576976|NCT00261443|144680732|SUPERIORITY_OR_OTHER_LEGACY|||||||0.18||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Baseline HDL Cholesterol (fasting)||||0.180
72576977|NCT00261443|144680732|SUPERIORITY_OR_OTHER_LEGACY|||||||0.95||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Change from Baseline in HDL Cholesterol (fasting) at Week 52 (LOCF)||||0.950
72402790|NCT01480076|144311693|SUPERIORITY_OR_OTHER||difference of LS means|0.03|STANDARD_ERROR_OF_MEAN|0.05||0.5089|TWO_SIDED||||||mixed effect model|||Month 9, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D index scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.5089
72486521|NCT01301456|144501454|SUPERIORITY_OR_OTHER||LS Mean Difference|-32.46|STANDARD_ERROR_OF_MEAN|11.872||0.011|TWO_SIDED|80.0|-48.07|-16.85|||Mixed meal tolerance test|||Day 15: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.||-16.85|-48.07|0.011
72486522|NCT01301456|144501454|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.61|STANDARD_ERROR_OF_MEAN|12.212||0.833|TWO_SIDED|80.0|-18.67|13.45|||Mixed meal tolerance test|||Day 15: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.||13.45|-18.67|0.833
72486523|NCT01301456|144501454|SUPERIORITY_OR_OTHER||LS Mean Difference|-7.21|STANDARD_ERROR_OF_MEAN|12.365||0.565|TWO_SIDED|80.0|-23.47|9.05|||Mixed meal tolerance test|||Day 15: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.||9.05|-23.47|0.565
72486524|NCT01301456|144501454|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.75|STANDARD_ERROR_OF_MEAN|9.713||0.703|TWO_SIDED|80.0|-16.52|9.02|||Mixed meal tolerance test|||Day 22: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.||9.02|-16.52|0.703
72486525|NCT01301456|144501454|SUPERIORITY_OR_OTHER||LS Mean Difference|-25.46|STANDARD_ERROR_OF_MEAN|8.827||0.008|TWO_SIDED|80.0|-37.07|-13.85|||Mixed meal tolerance test|||Day 22: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.||-13.85|-37.07|0.008
72486526|NCT01301456|144501454|SUPERIORITY_OR_OTHER||LS Mean Difference|-10.6|STANDARD_ERROR_OF_MEAN|9.061||0.253|TWO_SIDED|80.0|-22.51|1.32|||Mixed meal tolerance test|||Day 22: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.||1.32|-22.51|0.253
72486527|NCT01301456|144501454|SUPERIORITY_OR_OTHER||LS Mean Difference|-14.47|STANDARD_ERROR_OF_MEAN|9.198||0.128|TWO_SIDED|80.0|-26.57|-2.38|||Mixed meal tolerance test|||Day 22: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.||-2.38|-26.57|0.128
72486528|NCT01301456|144501454|SUPERIORITY_OR_OTHER||LS Mean Difference|-15.15|STANDARD_ERROR_OF_MEAN|11.421||0.196|TWO_SIDED|80.0|-30.17|-0.13|||Mixed meal tolerance test|||Day 29: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.||-0.13|-30.17|0.196
72486529|NCT01301456|144501454|SUPERIORITY_OR_OTHER||LS Mean Difference|-28.17|STANDARD_ERROR_OF_MEAN|10.393||0.012|TWO_SIDED|80.0|-41.84|-14.51|||Mixed meal tolerance test|||Day 29: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.||-14.51|-41.84|0.012
72486530|NCT01301456|144501454|SUPERIORITY_OR_OTHER||LS Mean Difference|-22.48|STANDARD_ERROR_OF_MEAN|10.773||0.047|TWO_SIDED|80.0|-36.65|-8.32|||Mixed meal tolerance test|||Day 29: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.||-8.32|-36.65|0.047
72486531|NCT01301456|144501454|SUPERIORITY_OR_OTHER||LS Mean Difference|-28.63|STANDARD_ERROR_OF_MEAN|11.837||0.023|TWO_SIDED|80.0|-44.19|-13.06|||Mixed meal tolerance test|||Day 29: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.||-13.06|-44.19|0.023
72486532|NCT01301456|144501454|SUPERIORITY_OR_OTHER||LS Mean Difference|5.08|STANDARD_ERROR_OF_MEAN|13.576||0.711|TWO_SIDED|80.0|-12.77|22.93|||Mixed meal tolerance test|||Day 50: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.||22.93|-12.77|0.711
72486533|NCT01301456|144501454|SUPERIORITY_OR_OTHER||LS Mean Difference|5.4|STANDARD_ERROR_OF_MEAN|12.365||0.666|TWO_SIDED|80.0|-10.86|21.66|||Mixed meal tolerance test|||Day 50: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.||21.66|-10.86|0.666
72486534|NCT01301456|144501454|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.05|STANDARD_ERROR_OF_MEAN|12.333||0.807|TWO_SIDED|80.0|-19.27|13.17|||Mixed meal tolerance test|||Day 50: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.||13.17|-19.27|0.807
72486535|NCT01301456|144501454|SUPERIORITY_OR_OTHER||LS Mean Difference|6.79|STANDARD_ERROR_OF_MEAN|12.877||0.603|TWO_SIDED|80.0|-10.15|23.72|||Mixed meal tolerance test|||Day 50: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.||23.72|-10.15|0.603
72486536|NCT01301456|144501456|SUPERIORITY_OR_OTHER||LS Mean Difference|0.48|STANDARD_ERROR_OF_MEAN|0.551||0.387|TWO_SIDED|80.0|-0.24|1.21|||Mixed meal tolerance test|||Day 8: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.||1.21|-0.24|0.387
72486537|NCT01301456|144501456|SUPERIORITY_OR_OTHER||LS Mean Difference|0.52|STANDARD_ERROR_OF_MEAN|0.501||0.309|TWO_SIDED|80.0|-0.14|1.18|||Mixed meal tolerance test|||Day 8: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.||1.18|-0.14|0.309
72486538|NCT01301456|144501456|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.518||0.956|TWO_SIDED|80.0|-0.71|0.65|||Mixed meal tolerance test|||Day 8: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.||0.65|-0.71|0.956
72486539|NCT01301456|144501456|SUPERIORITY_OR_OTHER||LS Mean Difference|0.96|STANDARD_ERROR_OF_MEAN|0.542||0.089|TWO_SIDED|80.0|0.24|1.67|||Mixed meal tolerance test|||Day 8: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.||1.67|0.24|0.089
72513577|NCT03546413|144557638|SUPERIORITY|||||||0.729|||||||Regression, Logistic|||||||0.729
72486540|NCT01301456|144501456|SUPERIORITY_OR_OTHER||LS Mean Difference|0.73|STANDARD_ERROR_OF_MEAN|0.923||0.434|TWO_SIDED|80.0|-0.48|1.95|||Mixed meal tolerance test|||Day 15: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.||1.95|-0.48|0.434
72402791|NCT01480076|144311693|SUPERIORITY_OR_OTHER|||||||0.0141|||||||mixed effect model|||Month 12, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D index scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0141
72402792|NCT01480076|144311693|SUPERIORITY_OR_OTHER|||||||0.428|||||||mixed effect model|||Month 12, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D index scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.4280
72486541|NCT01301456|144501456|SUPERIORITY_OR_OTHER||LS Mean Difference|1.25|STANDARD_ERROR_OF_MEAN|0.841||0.15|TWO_SIDED|80.0|0.14|2.35|||Mixed meal tolerance test|||Day 15: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.||2.35|0.14|0.150
72486542|NCT01301456|144501456|SUPERIORITY_OR_OTHER||LS Mean Difference|0.27|STANDARD_ERROR_OF_MEAN|0.861||0.752|TWO_SIDED|80.0|-0.86|1.41|||Mixed meal tolerance test|||Day 15: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.||1.41|-0.86|0.752
72513578|NCT03546413|144557638|SUPERIORITY|A logistic regression model was used with a fixed effect comparing the Avoidance and Consumption cohorts and a random effect to account for siblings who are in the same family unit.||||||0.75|||||||Regression, Logistic|||||||0.750
72513579|NCT03546413|144557638|SUPERIORITY|A logistic regression model was used with a fixed effect comparing the Avoidance and Consumption cohorts and a random effect to account for siblings who are in the same family unit.||||||0.155|||||||Regression, Logistic|||||||0.155
72513580|NCT03546413|144557638|SUPERIORITY|A logistic regression model was used with a fixed effect comparing the Avoidance and Consumption cohorts and a random effect to account for parents who are in the same family unit.||||||0.458|||||||Regression, Logistic|||||||0.458
72513581|NCT03546413|144557639|SUPERIORITY|||||||0.33|||||||Regression, Logistic|||||||0.330
72513582|NCT03546413|144557639|SUPERIORITY|A logistic regression model was used with a fixed effect comparing the Avoidance and Consumption cohorts and a random effect to account for siblings who are in the same family unit.||||||0.351|||||||Regression, Logistic|||||||0.351
72513583|NCT03546413|144557639|SUPERIORITY|A logistic regression model was used with a fixed effect comparing the Avoidance and Consumption cohorts and a random effect to account for siblings who are in the same family unit.||||||0.502|||||||Regression, Logistic|||||||0.502
72513584|NCT03546413|144557639|SUPERIORITY|||||||0.732||||||A logistic regression model was used with a fixed effect comparing the Avoidance and Consumption cohorts and a random effect to account for parents who are in the same family unit.|Regression, Logistic|||||||0.732
72513585|NCT03546413|144557640|SUPERIORITY|A logistic regression model was used with a fixed effect comparing the Avoidance and Consumption cohorts and a random effect to account for siblings who are in the same family unit.||||||0.202|||||||Regression, Logistic|||||||0.202
72513586|NCT03546413|144557640|OTHER||||||||||||||Regression, Logistic||||A logistic regression model was used with a fixed effect comparing the Avoidance and Consumption cohorts and a random effect to account for siblings who are in the same family unit. However, the logistic regression model was unable to converge due to the low percentage of allergic participants in older siblings.|||
72513587|NCT03546413|144557640|OTHER||||||||||||||Regression, Logistic||||A logistic regression model was used with a fixed effect comparing the Avoidance and Consumption cohorts and a random effect to account for parents who are in the same family unit. However, the logistic regression model was unable to converge due to the low percentage of allergic participants in parents.|||
72513588|NCT03546413|144557641|SUPERIORITY|||||||0.029|||||||Regression, Logistic|||||||0.029
72576978|NCT00261443|144680732|SUPERIORITY_OR_OTHER_LEGACY|||||||0.342||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Lowest Value of Change in HDL Cholesterol (fasting) During Phase 3||||0.342
72486543|NCT01301456|144501456|SUPERIORITY_OR_OTHER||LS Mean Difference|0.62|STANDARD_ERROR_OF_MEAN|0.888||0.492|TWO_SIDED|80.0|-0.55|1.79|||Mixed meal tolerance test|||Day 15: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.||1.79|-0.55|0.492
72513589|NCT03546413|144557641|SUPERIORITY|A logistic regression model was used with a fixed effect comparing the Avoidance and Consumption cohorts and a random effect to account for siblings who are in the same family unit.||||||0.489|||||||Regression, Logistic|||||||0.489
72513590|NCT03546413|144557641|OTHER||||||||||||||Regression, Logistic||||A logistic regression model was used with a fixed effect comparing the Avoidance and Consumption cohorts and a random effect to account for siblings who are in the same family unit. However, the model was unable to converge due to the low percentage of peanut-related adverse events in older siblings.|||
72513591|NCT01089582|144557656|SUPERIORITY_OR_OTHER|||||||0.0023|TWO_SIDED||||||Regression, Logistic|||The effect of possible prognostic factors response on response rate: primary diagnosis severity. Participants were classified as responders if they were very much improved or much improved from baseline.||||0.0023
72513592|NCT01089582|144557657|SUPERIORITY_OR_OTHER|||||||0.0382|TWO_SIDED||||||Regression, Logistic|||The effect of possible prognostic factors on response: significant medical history. Participants were classified as responders if they were much improved or improved from baseline.||||0.0382
72513593|NCT01089582|144557658|SUPERIORITY_OR_OTHER|||||||0.1805|TWO_SIDED||||||Regression, Linear|||The effect of possible prognostic factors on response: primary diagnosis severity.||||0.1805
72513594|NCT01089582|144557658|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Regression, Linear|||The effect of possible prognostic factors on response: baseline QoL-AD score as assessed by participant.||||<0.0001
72513595|NCT01089582|144557658|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Regression, Linear|||The effect of possible prognostic factors on response: center number.||||<0.0001
72402793|NCT01480076|144311693|SUPERIORITY_OR_OTHER|||||||0.0002|||||||mixed effect model|||Month 12, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D index scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0002
72402794|NCT01480076|144311693|SUPERIORITY_OR_OTHER|||||||0.3827|||||||mixed effect model|||Month 12, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D index scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.3827
72402795|NCT01480076|144311693|SUPERIORITY_OR_OTHER||difference of LS means|0.06|STANDARD_ERROR_OF_MEAN|0.03||0.0748|TWO_SIDED||||||mixed effect model|||Month 12, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D index scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0748
72486544|NCT01301456|144501456|SUPERIORITY_OR_OTHER||LS Mean Difference|1.0|STANDARD_ERROR_OF_MEAN|1.064||0.358|TWO_SIDED|80.0|-0.4|2.4|||Mixed meal tolerance test|||Day 22: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.||2.40|-0.40|0.358
72486545|NCT01301456|144501456|SUPERIORITY_OR_OTHER||LS mean Difference|1.6|STANDARD_ERROR_OF_MEAN|0.97||0.11|TWO_SIDED|80.0|0.33|2.88|||Mixed meal tolerance test|||Day 22: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.||2.88|0.33|0.110
72486546|NCT01301456|144501456|SUPERIORITY_OR_OTHER||LS mean Difference|0.74|STANDARD_ERROR_OF_MEAN|0.993||0.461|TWO_SIDED|80.0|-0.56|2.05|||Mixed meal tolerance test|||Day 22: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.||2.05|-0.56|0.461
72486547|NCT01301456|144501456|SUPERIORITY_OR_OTHER||LS mean Difference|1.11|STANDARD_ERROR_OF_MEAN|1.021||0.286|TWO_SIDED|80.0|-0.23|2.45|||Mixed meal tolerance test|||Day 22: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.||2.45|-0.23|0.286
72486548|NCT01301456|144501456|SUPERIORITY_OR_OTHER||LS Mean Difference|1.09|STANDARD_ERROR_OF_MEAN|1.172||0.362|TWO_SIDED|80.0|-0.45|2.63|||Mixed meal tolerance test|||Day 29: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.||2.63|-0.45|0.362
72486549|NCT01301456|144501456|SUPERIORITY_OR_OTHER||LS Mean Difference|1.48|STANDARD_ERROR_OF_MEAN|1.069||0.179|TWO_SIDED|80.0|0.07|2.88|||Mixed meal tolerance test|||Day 29: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.||2.88|0.07|0.179
72486550|NCT01301456|144501456|SUPERIORITY_OR_OTHER||LS Mean Difference|1.06|STANDARD_ERROR_OF_MEAN|1.092||0.342|TWO_SIDED|80.0|-0.38|2.49|||Mixed meal tolerance test|||Day 29: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.||2.49|-0.38|0.342
72486551|NCT01301456|144501456|SUPERIORITY_OR_OTHER||LS Mean Difference|1.27|STANDARD_ERROR_OF_MEAN|1.129||0.272|TWO_SIDED|80.0|-0.22|2.75|||Mixed meal tolerance test|||Day 29: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.||2.75|-0.22|0.272
72486552|NCT01301456|144501456|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|1.317||0.979|TWO_SIDED|80.0|-1.77|1.7|||Mixed meal tolerance test|||Day 50: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.||1.70|-1.77|0.979
72486553|NCT01301456|144501456|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|1.201||0.568|TWO_SIDED|80.0|-2.27|0.88|||Mixed meal tolerance test|||Day 50: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.||0.88|-2.27|0.568
72486554|NCT01301456|144501456|SUPERIORITY_OR_OTHER||LS Mean Difference|1.24|STANDARD_ERROR_OF_MEAN|1.201||0.311|TWO_SIDED|80.0|-0.34|2.82|||Mixed meal tolerance test|||Day 50: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.||2.82|-0.34|0.311
72486555|NCT01301456|144501456|SUPERIORITY_OR_OTHER||LS Mean Difference|0.47|STANDARD_ERROR_OF_MEAN|1.26||0.71|TWO_SIDED|80.0|-1.18|2.13|||Mixed meal tolerance test|||Day 50: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.||2.13|-1.18|0.710
72486556|NCT01380730|144501472|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-66.1|STANDARD_ERROR_OF_MEAN|2.73|<|0.001|TWO_SIDED|95.0|-71.48|-60.72||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factors.|Placebo is the reference|The null hypothesis was that there was no mean difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.||-60.72|-71.48|<0.001
72486557|NCT01380730|144501472|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-60.24|STANDARD_ERROR_OF_MEAN|2.73|<|0.001|TWO_SIDED|95.0|-65.61|-54.88||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factors.|Placebo is the reference|The null hypothesis was that there was no mean difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.||-54.88|-65.61|<0.001
72513596|NCT01089582|144557659|SUPERIORITY_OR_OTHER|||||||0.0137|TWO_SIDED||||||Regression, Linear|||The effect of possible prognostic factors on response: primary diagnosis severity.||||0.0137
72513597|NCT01089582|144557659|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Regression, Linear|||The effect of possible prognostic factors on response: baseline QoL-AD score as assessed by caregiver.||||<0.0001
72402796|NCT01480076|144311693|SUPERIORITY_OR_OTHER||least squares mean|0.03|STANDARD_ERROR_OF_MEAN|0.05||0.5663|TWO_SIDED||||||mixed effect model|||Month 12, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D index scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.5663
72486558|NCT01380730|144501472|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-41.82|STANDARD_ERROR_OF_MEAN|2.73|<|0.001|TWO_SIDED|95.0|-47.18|-36.45||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factors.|Placebo is the reference|The null hypothesis was that there was no mean difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.||-36.45|-47.18|<0.001
72576979|NCT00261443|144680733|SUPERIORITY_OR_OTHER_LEGACY|||||||0.349||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Baseline HOMA2-Percent Beta||||0.349
72486559|NCT01380730|144501472|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-50.33|STANDARD_ERROR_OF_MEAN|2.9|<|0.001|TWO_SIDED|95.0|-56.04|-44.62||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factors.|Placebo is the reference|The null hypothesis was that there was no mean difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.||-44.62|-56.04|<0.001
72486560|NCT01380730|144501472|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-50.0|STANDARD_ERROR_OF_MEAN|2.89|<|0.001|TWO_SIDED|95.0|-55.69|-44.31||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factors.|Placebo is the reference|The null hypothesis was that there was no mean difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.||-44.31|-55.69|<0.001
72486561|NCT01380730|144501472|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-41.84|STANDARD_ERROR_OF_MEAN|2.9|<|0.001|TWO_SIDED|95.0|-47.55|-36.13||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factors.|Placebo is the reference|The null hypothesis was that there was no mean difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.||-36.13|-47.55|<0.001
72486562|NCT01380730|144501473|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-79.2|STANDARD_ERROR_OF_MEAN|4.0|<|0.001|TWO_SIDED|95.0|-87.0|-71.5||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factors.|Placebo is the reference|||-71.5|-87.0|<0.001
72486563|NCT01380730|144501473|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-77.4|STANDARD_ERROR_OF_MEAN|4.0|<|0.001|TWO_SIDED|95.0|-85.2|-69.6||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factors.|Placebo is the reference|||-69.6|-85.2|<0.001
72486564|NCT01380730|144501473|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-50.7|STANDARD_ERROR_OF_MEAN|4.0|<|0.001|TWO_SIDED|95.0|-58.5|-43.0||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factors.|Placebo is the reference|||-43.0|-58.5|<0.001
72486565|NCT01380730|144501473|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-61.1|STANDARD_ERROR_OF_MEAN|3.8|<|0.001|TWO_SIDED|95.0|-68.6|-53.7||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factors.|Placebo is the reference|||-53.7|-68.6|<0.001
72486566|NCT01380730|144501473|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-61.1|STANDARD_ERROR_OF_MEAN|3.8|<|0.001|TWO_SIDED|95.0|-68.5|-53.7||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factors.|Placebo is the reference|||-53.7|-68.5|<0.001
72486567|NCT01380730|144501473|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-50.6|STANDARD_ERROR_OF_MEAN|3.8|<|0.001|TWO_SIDED|95.0|-58.0|-43.1||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factors.|Placebo is the reference|||-43.1|-58.0|<0.001
72486568|NCT01380730|144501474|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-61.4|STANDARD_ERROR_OF_MEAN|2.53|<|0.001|TWO_SIDED|95.0|-66.37|-56.43||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factors.|Placebo is the reference|||-56.43|-66.37|<0.001
72486569|NCT01380730|144501474|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-55.42|STANDARD_ERROR_OF_MEAN|2.52|<|0.001|TWO_SIDED|95.0|-60.37|-50.47||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factors.|Placebo is the reference|||-50.47|-60.37|<0.001
72486570|NCT01380730|144501474|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-38.44|STANDARD_ERROR_OF_MEAN|2.52|<|0.001|TWO_SIDED|95.0|-43.39|-33.48||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factors.|Placebo is the reference|||-33.48|-43.39|<0.001
72486571|NCT01380730|144501474|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-47.58|STANDARD_ERROR_OF_MEAN|2.61|<|0.001|TWO_SIDED|95.0|-52.72|-42.44||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factors.|Placebo is the reference|||-42.44|-52.72|<0.001
72486572|NCT01380730|144501474|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-45.8|STANDARD_ERROR_OF_MEAN|2.6|<|0.001|TWO_SIDED|95.0|-50.92|-40.67||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factors.|Placebo is the reference|||-40.67|-50.92|<0.001
72486573|NCT01380730|144501474|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-37.79|STANDARD_ERROR_OF_MEAN|2.61|<|0.001|TWO_SIDED|95.0|-42.94|-32.65||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factors.|Placebo is the reference|||-32.65|-42.94|<0.001
72513598|NCT01089582|144557659|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Regression, Linear|||The effect of possible prognostic factors on response: center number.||||<0.0001
72513599|NCT02108600|144557663|OTHER|||||||0.033|TWO_SIDED|95.0|||||Fisher Exact|||||||0.033
72567887|NCT03456960|144667437|EQUIVALENCE|Pilot Study 1: The difference in the LSM between study medications (TAK-438ASA tablet - concomitant administration of TAK-438 tablet and aspirin enteric-coated tablet) and the two-sided 90% CI were provided using a crossover ANOVA model. The ANOVA model included a log-transformed (natural log) analysis variable as the dependent variable, and study medication, sequence, and period as independent variables.|LSM Difference|0.0148|||||TWO_SIDED|90.0|-0.0734|0.103||||||||0.1030|-0.0734|
72567888|NCT03456960|144667437|EQUIVALENCE|Pivotal Study 1: The difference in the LSM between study medications (TAK-438ASA tablet - concomitant administration of TAK-438 tablet and aspirin enteric-coated tablet) and the two-sided 90% CI were provided using a crossover ANOVA model. The ANOVA model included a log-transformed (natural log) analysis variable as the dependent variable, and study medication, sequence, and period as independent variables.|LSM Difference|-0.002|||||TWO_SIDED|90.0|-0.0463|0.0424||||||||0.0424|-0.0463|
72567889|NCT03456960|144667438|EQUIVALENCE|TAK-438F: The difference in the LSM between dosing condition (TAK-438ASA tablet taken in a fed \[30 minutes after starting breakfast\] - TAK-438ASA tablet taken in a fasted \[without breakfast\] condition) and the two-sided 90% CI were provided using a crossover ANOVA model. The ANOVA model included a log-transformed (natural log) analysis variable as the dependent variable, and dosing condition, sequence, and period as independent variables.|LSM Difference|0.2138|||||TWO_SIDED|90.0|0.1609|0.2667||||||||0.2667|0.1609|
72567890|NCT03456960|144667439|EQUIVALENCE|TAK-438F: The difference in the LSM between dosing condition (TAK-438ASA tablet taken in a fed \[30 minutes after starting breakfast\] - TAK-438ASA tablet taken in a fasted \[without breakfast\] condition) and the two-sided 90% CI were provided using a crossover ANOVA model. The ANOVA model included a log-transformed (natural log) analysis variable as the dependent variable, and dosing condition, sequence, and period as independent variables.|LSM Difference|0.2161|||||TWO_SIDED|90.0|0.1652|0.2671||||||||0.2671|0.1652|
72567891|NCT03456960|144667440|EQUIVALENCE|TAK-438F: The difference in the LSM between dosing condition (TAK-438ASA tablet taken in a fed \[30 minutes after starting breakfast\] - TAK-438ASA tablet taken in a fasted \[without breakfast\] condition) and the two-sided 90% CI were provided using a crossover ANOVA model. The ANOVA model included a log-transformed (natural log) analysis variable as the dependent variable, and dosing condition, sequence, and period as independent variables.|LSM Difference|0.219|||||TWO_SIDED|90.0|0.1675|0.2706||||||||0.2706|0.1675|
72567892|NCT03456960|144667441|EQUIVALENCE|TAK-438F: The difference in the LSM between dosing condition (TAK-438ASA tablet taken in a fed \[30 minutes after starting breakfast\] - TAK-438ASA tablet taken in a fasted \[without breakfast\] condition) and the two-sided 90% CI were provided using a crossover ANOVA model. The ANOVA model included a log-transformed (natural log) analysis variable as the dependent variable, and dosing condition, sequence, and period as independent variables.|LSM Difference|0.3653|||||TWO_SIDED|90.0|0.218|0.5126||||||||0.5126|0.2180|
72567893|NCT03456960|144667444|EQUIVALENCE|Unchanged aspirin: The difference in the LSM between dosing condition (TAK-438ASA tablet taken in a fed \[30 minutes after starting breakfast\] - TAK-438ASA tablet taken in a fasted \[without breakfast\] condition) and the two-sided 90% CI were provided using a crossover ANOVA model. The ANOVA model included a log-transformed (natural log) analysis variable as the dependent variable, and dosing condition, sequence, and period as independent variables.|LSM Difference|0.2089|||||TWO_SIDED|90.0|-0.0061|0.4239||||||||0.4239|-0.0061|
72567894|NCT03456960|144667444|EQUIVALENCE|Salicylic acid: The difference in the LSM between dosing condition (TAK-438ASA tablet taken in a fed \[30 minutes after starting breakfast\] - TAK-438ASA tablet taken in a fasted \[without breakfast\] condition) and the two-sided 90% CI were provided using a crossover ANOVA model. The ANOVA model included a log-transformed (natural log) analysis variable as the dependent variable, and dosing condition, sequence, and period as independent variables.|LSM Difference|0.014|||||TWO_SIDED|90.0|-0.0639|0.0918||||||||0.0918|-0.0639|
72567895|NCT03456960|144667445|EQUIVALENCE|Unchanged aspirin: The difference in the LSM between dosing condition (TAK-438ASA tablet taken in a fed \[30 minutes after starting breakfast\] - TAK-438ASA tablet taken in a fasted \[without breakfast\] condition) and the two-sided 90% CI were provided using a crossover ANOVA model. The ANOVA model included a log-transformed (natural log) analysis variable as the dependent variable, and dosing condition, sequence, and period as independent variables.|LSM Difference|0.2099|||||TWO_SIDED|90.0|-0.0048|0.4246||||||||0.4246|-0.0048|
72567896|NCT03456960|144667445|EQUIVALENCE|Salicylic acid: The difference in the LSM between dosing condition (TAK-438ASA tablet taken in a fed \[30 minutes after starting breakfast\] - TAK-438ASA tablet taken in a fasted \[without breakfast\] condition) and the two-sided 90% CI were provided using a crossover ANOVA model. The ANOVA model included a log-transformed (natural log) analysis variable as the dependent variable, and dosing condition, sequence, and period as independent variables.|LSM Difference|0.0137|||||TWO_SIDED|90.0|-0.0712|0.0986||||||||0.0986|-0.0712|
72567897|NCT03456960|144667446|EQUIVALENCE|Unchanged aspirin: The difference in the LSM between dosing condition (TAK-438ASA tablet taken in a fed \[30 minutes after starting breakfast\] - TAK-438ASA tablet taken in a fasted \[without breakfast\] condition) and the two-sided 90% CI were provided using a crossover ANOVA model. The ANOVA model included a log-transformed (natural log) analysis variable as the dependent variable, and dosing condition, sequence, and period as independent variables.|LSM Difference|0.2096|||||TWO_SIDED|90.0|-0.0054|0.4246||||||||0.4246|-0.0054|
72567898|NCT03456960|144667446|EQUIVALENCE|Salicylic acid: The difference in the LSM between dosing condition (TAK-438ASA tablet taken in a fed \[30 minutes after starting breakfast\] - TAK-438ASA tablet taken in a fasted \[without breakfast\] condition) and the two-sided 90% CI were provided using a crossover ANOVA model. The ANOVA model included a log-transformed (natural log) analysis variable as the dependent variable, and dosing condition, sequence, and period as independent variables.|LSM Difference|0.0201|||||TWO_SIDED|90.0|-0.069|0.1092||||||||0.1092|-0.0690|
72567899|NCT03456960|144667447|EQUIVALENCE|Unchanged aspirin: The difference in the LSM between dosing condition (TAK-438ASA tablet taken in a fed \[30 minutes after starting breakfast\] - TAK-438ASA tablet taken in a fasted \[without breakfast\] condition) and the two-sided 90% CI were provided using a crossover ANOVA model. The ANOVA model included a log-transformed (natural log) analysis variable as the dependent variable, and dosing condition, sequence, and period as independent variables.|LSM Difference|0.4058|||||TWO_SIDED|90.0|0.0803|0.7312||||||||0.7312|0.0803|
72567900|NCT03456960|144667447|EQUIVALENCE|Salicylic acid: The difference in the LSM between dosing condition (TAK-438ASA tablet taken in a fed \[30 minutes after starting breakfast\] - TAK-438ASA tablet taken in a fasted \[without breakfast\] condition) and the two-sided 90% CI were provided using a crossover ANOVA model. The ANOVA model included a log-transformed (natural log) analysis variable as the dependent variable, and dosing condition, sequence, and period as independent variables.|LSM Difference|0.1969|||||TWO_SIDED|90.0|0.1065|0.2873||||||||0.2873|0.1065|
72513600|NCT00862849|144557667|SUPERIORITY_OR_OTHER||LS Mean Difference|26.47|||<|0.0001|TWO_SIDED|90.0|18.22|34.71||Treatment comparison for %AUC(0-30). Statistical testing was considered exploratory, with no adjustment for inflation of Type 1 error due to multiplicity of testing.|Mixed Models Analysis|Analysis performed using mixed model with fixed effect for treatment. A compound symmetry covariance matrix among repeated measurements was assumed.||||34.71|18.22|<0.0001
72513601|NCT00862849|144557667|SUPERIORITY_OR_OTHER||LS Mean Difference|16.7||||0.0015|TWO_SIDED|90.0|8.45|24.94||Treatment comparison for %AUC(0-30). Statistical testing was considered exploratory, with no adjustment for inflation of Type 1 error due to multiplicity of testing.|Mixed Models Analysis|Analysis performed using mixed model with fixed effect for treatment. A compound symmetry covariance matrix among repeated measurements was assumed||||24.94|8.45|0.0015
72513602|NCT01735617|144557678|SUPERIORITY_OR_OTHER||Geometric means|563.38|STANDARD_DEVIATION|162.51|||TWO_SIDED|||||||||The pharmacokinetic profile was characterised by an overnight rise in cortisol levels reaching a maximal concentration approximately 8 hours post dosing.||||
72513603|NCT02344407|144557688|SUPERIORITY|||||||0.68|||||||Chi-squared|Bernards Exact Test Chi-square||Each active vaccine is compared to the placebo group||||0.68
72513604|NCT02344407|144557688|SUPERIORITY|||||||0.68|||||||Chi-squared|Barnard Exact Test Chi-square||||||0.68
72513605|NCT02344407|144557689|SUPERIORITY||||||<|0.001|||||||ANCOVA|Linear regression (analysis of covariance) adjusted for baseline antibody level||||||<0.001
72513606|NCT02344407|144557689|SUPERIORITY||||||<|0.001|||||||ANCOVA|Analysis of covariance adjusting for baseline antibody level||||||<0.001
72513607|NCT01102218|144557714|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||ANCOVA|||||||>0.05
72513608|NCT01658579|144557742|SUPERIORITY_OR_OTHER||Least Squares (LS) Mean Difference|0.75|STANDARD_ERROR_OF_MEAN|2.179||0.7304|TWO_SIDED|95.0|-3.614|5.124|||Linear Mixed Model|||Analysis was performed using a linear mixed model with treatment and period as fixed effects, and participant as random effect.||5.124|-3.614|0.7304
72513609|NCT00608530|144557761|SUPERIORITY_OR_OTHER|||||||0.05|||||||ANOVA|||Repeated measures analysis of variance compared differences between and within groups (CBT and Supportive Care) from baseline to end of treatment. Statistical testing was performed using 2-tailed tests and alpha level of .05 for declaring statistical significance. The trial was powered at the \>.80 level to detect differences between condition based on projected sample N = 130; given the N = 66 actually achieved our a priori power for detecting differences between groups was .63.||||.05
72513610|NCT00608530|144557762|SUPERIORITY|||||||0.05|||||||ANOVA|||Primary analyses consisted of modified intent-to-treat analysis of all randomized participants who attended at least 1 treatment session, with multiple imputation to address missing data. The study was powered at 80% to detect large effect sizes (\>.50SD) and alpha of .05 with a recruitment goal N = 140; with the N = 61 actually obtained, our a priori power was .55 to detect between group differences.||||.05
72513611|NCT00608530|144557763|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||ANOVA|||Repeated measures analysis of variance comparing groups at baseline and end of treatment.||||>0.05
72513612|NCT00608530|144557765|SUPERIORITY_OR_OTHER|||||||0.05|||||||Fisher Exact|||||||.05
72513613|NCT01019486|144557779|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||t-test, 2 sided|||Independent Student t test between arms with two tailed analysis||||<0.05
72513614|NCT01019486|144557779|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||t-test, 2 sided|||Independent Student t test between arms with two tailed analysis.||||<0.05
72567901|NCT02037165|144667467|SUPERIORITY_OR_OTHER||adjusted mean difference|1.12|STANDARD_ERROR_OF_MEAN|2.0801|||TWO_SIDED|95.0|-3.0|5.2|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 0:30h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||5.2|-3.0|
72576980|NCT00261443|144680733|SUPERIORITY_OR_OTHER_LEGACY|||||||0.624||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Change from Baseline in HOMA2-Percent Beta at Week 52 (LOCF)||||0.624
72513615|NCT01019486|144557779|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||t-test, 2 sided|||Independent Student t test between groups with two-tailed analysis||||<0.05
72513616|NCT01019486|144557780|NON_INFERIORITY_OR_EQUIVALENCE|If sufficient subjects were enrolled then it would be expected that the MRI measurement of myocardial blood flow MBF would similar or equivalent to the invasively measured CFR in response to intravenous regadenoson administration.|None insufficient data|2.0||||0.05|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||No analysis was performed due to limited data.||||0.05
72513617|NCT01019486|144557781|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||Comparison between groups using a two-tailed Student t test||||<.05
72513618|NCT02841787|144557786|SUPERIORITY||||||<|0.001||||||The threshold for significance was alpha=0.05.|t-test, 2 sided|||||||< .001
72513619|NCT02841787|144557786|SUPERIORITY||||||<|0.001||||||The threshold for significance was alpha=0.05.|t-test, 2 sided|||||||<.001
72513620|NCT02841787|144557786|SUPERIORITY|||||||0.44||||||The threshold for significance was alpha=0.05.|t-test, 2 sided|||||||0.44
72513621|NCT02841787|144557786|SUPERIORITY|||||||0.03||||||The threshold for significance was alpha=0.05.|ANOVA|||||||0.03
72513622|NCT02841787|144557786|SUPERIORITY|||||||0.68||||||The threshold for significance was alpha=0.05.|t-test, 2 sided|||||||0.68
72513623|NCT02841787|144557786|SUPERIORITY|||||||0.02||||||The threshold for significance was alpha=0.05.|t-test, 2 sided|||||||0.02
72513624|NCT02841787|144557786|SUPERIORITY|||||||0.03||||||The threshold for significance was alpha=0.05.|t-test, 2 sided|||||||0.03
72513625|NCT02841787|144557789|SUPERIORITY|||||||0.003||||||The threshold for significance was alpha=0.05.|t-test, 2 sided|||||||0.003
72513626|NCT02130258|144557979|OTHER|||||||0.04|||||||Kruskal-Wallis|||||||.04
72513627|NCT02130258|144557980|OTHER|||||||0.04|||||||Kruskal-Wallis|||||||.04
72513628|NCT02130258|144557981|OTHER|||||||0.04|||||||Kruskal-Wallis|||||||0.04
72513629|NCT02951988|144557982|SUPERIORITY|||||||0.5305|||||||Log Rank|||||||0.5305
72513630|NCT02951988|144557982|SUPERIORITY|||||||0.4628|||||||Log Rank|||||||0.4628
72513631|NCT02951988|144557983|SUPERIORITY|||||||0.6153|||||||Log Rank|||||||0.6153
72513632|NCT02951988|144557983|SUPERIORITY|||||||0.4123|||||||Log Rank|||||||0.4123
72486574|NCT01380730|144501475|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-56.45|STANDARD_ERROR_OF_MEAN|2.46|<|0.001|TWO_SIDED|95.0|-61.28|-51.61||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factors.|Placebo is the reference|||-51.61|-61.28|<0.001
72486575|NCT01380730|144501475|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-50.15|STANDARD_ERROR_OF_MEAN|2.45|<|0.001|TWO_SIDED|95.0|-54.97|-45.33||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factors.|Placebo is the reference|||-45.33|-54.97|<0.001
72486576|NCT01380730|144501475|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-34.74|STANDARD_ERROR_OF_MEAN|2.45|<|0.001|TWO_SIDED|95.0|-39.56|-29.92||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factors.|Placebo is the reference|||-29.92|-39.56|<0.001
72486577|NCT01380730|144501475|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-42.03|STANDARD_ERROR_OF_MEAN|2.61|<|0.001|TWO_SIDED|95.0|-47.16|-36.9||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factors.|Placebo is the reference|||-36.90|-47.16|<0.001
72486578|NCT01380730|144501475|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-40.77|STANDARD_ERROR_OF_MEAN|2.6|<|0.001|TWO_SIDED|95.0|-45.88|-35.66||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factors.|Placebo is the reference|||-35.66|-45.88|<0.001
72486579|NCT01380730|144501475|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-34.38|STANDARD_ERROR_OF_MEAN|2.61|<|0.001|TWO_SIDED|95.0|-39.51|-29.25||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factors.|Placebo is the reference|||-29.25|-39.51|<0.001
72486580|NCT01380730|144501476|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-47.74|STANDARD_ERROR_OF_MEAN|2.26|<|0.001|TWO_SIDED|95.0|-52.18|-43.29||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factors.|Placebo is the reference|||-43.29|-52.18|<0.001
72486581|NCT01380730|144501476|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-43.38|STANDARD_ERROR_OF_MEAN|2.25|<|0.001|TWO_SIDED|95.0|-47.81|-38.94||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factors.|Placebo is the reference|||-38.94|-47.81|<0.001
72486582|NCT01380730|144501476|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-31.4|STANDARD_ERROR_OF_MEAN|2.25|<|0.001|TWO_SIDED|95.0|-35.83|-26.97||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factors.|Placebo is the reference|||-26.97|-35.83|<0.001
72486583|NCT01380730|144501476|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-35.65|STANDARD_ERROR_OF_MEAN|2.2|<|0.001|TWO_SIDED|95.0|-39.99|-31.32||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factors.|Placebo is the reference|||-31.32|-39.99|<0.001
72486584|NCT01380730|144501476|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-35.97|STANDARD_ERROR_OF_MEAN|2.2|<|0.001|TWO_SIDED|95.0|-40.29|-31.65||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factors.|Placebo is the reference|||-31.65|-40.29|<0.001
72486585|NCT01380730|144501476|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-27.73|STANDARD_ERROR_OF_MEAN|2.2|<|0.001|TWO_SIDED|95.0|-32.06|-23.39||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factors.|Placebo is the reference|||-23.39|-32.06|<0.001
72486586|NCT01380730|144501477|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-53.44|STANDARD_ERROR_OF_MEAN|2.44|<|0.001|TWO_SIDED|95.0|-58.23|-48.65||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factors.|Placebo is the reference|||-48.65|-58.23|<0.001
72486587|NCT01380730|144501477|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-47.3|STANDARD_ERROR_OF_MEAN|2.43|<|0.001|TWO_SIDED|95.0|-52.08|-42.52||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factors.|Placebo is the reference|||-42.52|-52.08|<0.001
72486588|NCT01380730|144501477|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-34.75|STANDARD_ERROR_OF_MEAN|2.43|<|0.001|TWO_SIDED|95.0|-39.53|-29.97||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factors.|Placebo is the reference|||-29.97|-39.53|<0.001
72486589|NCT01380730|144501477|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-42.93|STANDARD_ERROR_OF_MEAN|2.76|<|0.001|TWO_SIDED|95.0|-48.36|-37.5||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factors.|Placebo is the reference|||-37.50|-48.36|<0.001
72486590|NCT01380730|144501477|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-42.4|STANDARD_ERROR_OF_MEAN|2.75|<|0.001|TWO_SIDED|95.0|-47.81|-36.98||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factors.|Placebo is the reference|||-36.98|-47.81|<0.001
72486591|NCT01380730|144501477|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-33.77|STANDARD_ERROR_OF_MEAN|2.76|<|0.001|TWO_SIDED|95.0|-39.2|-28.33||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factors.|Placebo is the reference|||-28.33|-39.20|<0.001
72486592|NCT01854645|144501518|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|||At 5 min post dose||||<0.0001
72486593|NCT01854645|144501518|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|||At 15 min post dose||||<0.0001
72513633|NCT03977727|144557985|SUPERIORITY||Mean Difference (Final Values)|27.35||||0.008|TWO_SIDED|95.0|7.88|48.4|||Mixed Models Analysis|||Linear mixed model was fit with therapy (Fiasp vs. NovoLog), period (Period 1 vs Period 2), and sequence (Fiasp/NovoLog vs NovoLog/Fiasp) as fixed effects. Subjects included as random effects.||48.4|7.88|.008
72513634|NCT03977727|144557986|SUPERIORITY||Mean Difference (Final Values)|15.22||||0.136|TWO_SIDED|95.0|-5.42|39.46|||Mixed Models Analysis|||Linear mixed model was fit with therapy (Fiasp vs. NovoLog), period (Period 1 vs Period 2), and sequence (Fiasp/NovoLog vs NovoLog/Fiasp) as fixed effects. Subjects included as random effects.||39.46|-5.42|.136
72486594|NCT01854645|144501518|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|||At 5 min post dose||||<0.0001
72486595|NCT01854645|144501518|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|||At 15 min post dose||||<0.0001
72486596|NCT01854645|144501518|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|||At 5 min post dose||||<0.0001
72486597|NCT01854645|144501518|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|||At 15 min post dose||||<0.0001
72486598|NCT00545402|144501524|SUPERIORITY_OR_OTHER|||||||0.2611|||||||Log Rank|||||||0.2611
72486599|NCT00545402|144501526|SUPERIORITY_OR_OTHER|||||||0.7091|||||||Log Rank|||||||0.7091
72486600|NCT01721876|144501529|SUPERIORITY|The 2-sided test of the hypothesis was performed at a 0.05 level of significance. An odds ratio (OR) = 1 would indicate that the odds of achieving CR+CRi with Volasertib + Low-dose Cytarabine is equal to the odds of achieving CR+CRi with Placebo + Low-dose Cytarabine , whereas an OR ≠ 1 would indicate the opposite. H0, CR+CRi: OR = 1 vs. Ha, CR+CRi: OR ≠ 1.|Odds Ratio (OR)|1.8751||||0.0024|TWO_SIDED|95.0|1.2432|2.8281|||Cochran-Mantel-Haenszel||Common odds ratio is calculated by Mantel-Haenszel estimate adjusting for the two stratification factors (baseline Eastern Cooperative Oncology Group (ECOG) and type of AML). If odds ratio is above 1 then it favours Volasertib+Low-dose Cytarabine.|This analysis was exploratory and descriptive.||2.8281|1.2432|0.0024
72513635|NCT03977727|144557987|SUPERIORITY||Mean Difference (Final Values)|0.4||||0.029|TWO_SIDED|95.0|0.05|0.73|||Mixed Models Analysis|||Linear mixed model was fit with therapy (Fiasp vs. NovoLog), period (Period 1 vs Period 2), and sequence (Fiasp/NovoLog vs NovoLog/Fiasp) as fixed effects. Subjects included as random effects.||.73|.05|.029
72513636|NCT03977727|144557988|SUPERIORITY||Mean Difference (Final Values)|-1.81||||0.016|TWO_SIDED|95.0|-2.84|-0.31|||Mixed Models Analysis|||Linear mixed model was fit with therapy (Fiasp vs. NovoLog), period (Period 1 vs Period 2), and sequence (Fiasp/NovoLog vs NovoLog/Fiasp) as fixed effects. Subjects included as random effects.||-0.31|-2.84|.016
72486601|NCT01721876|144501530|SUPERIORITY|The hazard ratio (HR) between Volasertib + Low-dose Cytarabine and Placebo + Low-dose Cytarabine was tested against 1. The null hypothesis, H0,OS, was that the hazards are equal between Volasertib + Low-dose Cytarabine and Placebo + Low-dose Cytarabine, whereas the alternative hypothesis, Ha,OS, was that the hazards are not equal between the 2 treatment arms. H0, OS: HR = 1 vs. Ha, OS: HR ≠ 1.|Hazard Ratio (HR)|0.97||||0.7571|TWO_SIDED|95.0|0.8|1.2||P-value is calculated from log-rank test stratified by baseline ECOG (0-1 vs. 2) and type of AML (denovo vs. secondary).|Regression, Cox||Hazard ratio is calculated from Cox proportional hazard model stratified by baseline ECOG and type of AML. If hazard ratio is below 1 then it favours volasertib.|This analysis was exploratory and descriptive.||1.2|0.8|0.7571
72486602|NCT01721876|144501531|SUPERIORITY|The hazard ratio (HR) between Volasertib + Low-dose Cytarabine and Placebo + Low-dose Cytarabine was tested against 1. The null hypothesis, H0,OS, was that the hazards are equal between Volasertib + Low-dose Cytarabine and Placebo + Low-dose Cytarabine, whereas the alternative hypothesis, Ha,OS, was that the hazards are not equal between the 2 treatment arms. H0, OS: HR = 1 vs. Ha, OS: HR ≠ 1.|Hazard Ratio (HR)|0.96||||0.6718|TWO_SIDED|95.0|0.8|1.2||P-value is calculated from log-rank test stratified by baseline ECOG (0-1 vs. 2) and type of AML (denovo vs. secondary).|Regression, Cox||Hazard ratio is calculated from Cox proportional hazard model stratified by baseline ECOG and type of AML. If hazard ratio is below 1 then it favours volasertib.|This analysis was exploratory and descriptive.||1.2|0.8|0.6718
72486603|NCT01721876|144501532|OTHER||Hazard Ratio (HR)|1.37|||||TWO_SIDED|95.0|0.7|2.7|||Regression, Cox||Hazard ratio is calculated from Cox proportional hazard model stratified by baseline ECOG and type of AML. If hazard ratio is below 1 then it favours volasertib.|||2.7|0.7|
72486604|NCT03086265|144501533|OTHER|||||||0.7934|||||||t-test, 2 sided|||||||0.7934
72513637|NCT03977727|144557989|SUPERIORITY||Mean Difference (Final Values)|1.38||||0.045|TWO_SIDED|95.0|0.04|2.32|||Mixed Models Analysis|||Linear mixed model was fit with therapy (Fiasp vs. NovoLog), period (Period 1 vs Period 2), and sequence (Fiasp/NovoLog vs NovoLog/Fiasp) as fixed effects. Subjects included as random effects.||2.32|.04|.045
72513638|NCT03977727|144557992|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.303|TWO_SIDED|95.0|-0.59|0.16|||Mixed Models Analysis|||Linear mixed model was fit with therapy (Fiasp vs. NovoLog), period (Period 1 vs Period 2), and sequence (Fiasp/NovoLog vs NovoLog/Fiasp) as fixed effects. Subjects included as random effects.||.16|-.59|.303
72486605|NCT03086265|144501542|OTHER|||||||0.6876|||||||t-test, 2 sided|||||||0.6876
72486606|NCT03086265|144501543|OTHER|||||||0.7549|||||||t-test, 2 sided|||||||0.7549
72486607|NCT03086265|144501544|OTHER|||||||0.6479|||||||t-test, 2 sided|||||||0.6479
72486608|NCT03086265|144501545|OTHER|||||||0.8322|||||||t-test, 2 sided|||||||0.8322
72486609|NCT03086265|144501547|OTHER|||||||0.0058|||||||t-test, 2 sided|||||||0.0058
72486610|NCT03086265|144501548|OTHER|||||||0.3346|||||||t-test, 2 sided|||||||0.3346
72486611|NCT03086265|144501549|OTHER|||||||0.5513|||||||t-test, 2 sided|||||||0.5513
72486612|NCT03086265|144501550|OTHER|||||||0.1927|||||||t-test, 2 sided|||||||0.1927
72486613|NCT03086265|144501551|OTHER|||||||0.6483|||||||t-test, 2 sided|||||||0.6483
72486614|NCT03086265|144501552|OTHER|||||||0.5625|||||||t-test, 2 sided|||||||0.5625
72486615|NCT03086265|144501553|OTHER|||||||0.2827|||||||t-test, 2 sided|||||||0.2827
72486616|NCT03086265|144501554|OTHER|||||||0.8426|||||||t-test, 2 sided|||||||0.8426
72486617|NCT03086265|144501555|OTHER|||||||0.9856|||||||t-test, 2 sided|||||||0.9856
72486618|NCT03086265|144501556|OTHER|||||||0.8112|||||||t-test, 2 sided|||||||0.8112
72486619|NCT03086265|144501557|OTHER|||||||0.6587|||||||t-test, 2 sided|||||||0.6587
72486620|NCT03086265|144501558|OTHER|||||||0.4143|||||||t-test, 2 sided|||||||0.4143
72486621|NCT03086265|144501559|OTHER|||||||0.4324|||||||t-test, 2 sided|||||||0.4324
72486622|NCT03086265|144501560|OTHER|||||||0.7221|||||||t-test, 2 sided|||Comparison of preoperative scores.||||0.7221
72486623|NCT03086265|144501560|OTHER|||||||0.0336|||||||t-test, 2 sided|||Comparison of postoperative scores.||||0.0336
72486624|NCT01721057|144501561|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|TWO_SIDED||||||Regression, Logistic|||||||0.001
72576981|NCT00261443|144680733|SUPERIORITY_OR_OTHER_LEGACY|||||||0.329||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Highest Value in HOMA2-Percent Beta During Phase 3||||0.329
72576982|NCT00261443|144680734|SUPERIORITY_OR_OTHER_LEGACY|||||||0.55||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Baseline HOMA2-IR||||0.550
72486625|NCT01202279|144501582|SUPERIORITY_OR_OTHER_LEGACY|||||||0.025||95.0|||||Fisher Exact|||||||0.025
72567902|NCT02037165|144667467|SUPERIORITY_OR_OTHER||adjusted mean difference|2.66|STANDARD_ERROR_OF_MEAN|2.0796|||TWO_SIDED|95.0|-1.4|6.8|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 1:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||6.8|-1.4|
72567903|NCT02037165|144667467|SUPERIORITY_OR_OTHER||adjusted mean difference|3.0|STANDARD_ERROR_OF_MEAN|2.0792|||TWO_SIDED|95.0|-1.1|7.1|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 2:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||7.1|-1.1|
72576983|NCT00261443|144680734|SUPERIORITY_OR_OTHER_LEGACY|||||||0.554||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Change from Baseline in HOMA2-IR at Week 52 (LOCF)||||0.554
72576984|NCT00261443|144680734|SUPERIORITY_OR_OTHER_LEGACY|||||||0.87||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Highest Value of Change in HOMA2-IR, Phase 3 Safety Sample||||0.870
72576985|NCT00261443|144680735|SUPERIORITY_OR_OTHER_LEGACY|||||||0.004||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Baseline Lactate Dehydrogenase||||0.004
72486626|NCT01202279|144501583|SUPERIORITY_OR_OTHER_LEGACY|||||||0.022||95.0|||||ANCOVA|||||||0.022
72486627|NCT02064920|144501613|SUPERIORITY_OR_OTHER||Change in SD from Week 4 to Week 16|0.005|||||TWO_SIDED|95.0|-0.031|0.039|||||SD of average OCL repeated measurements after 12 weeks of treatment for Placebo + Donezepil treatment groups combined is hypothesized to be ≤ 0.1.|Change from Week 4 to Week 16 in Standard Deviation (SD) of OCL for Placebo + Donezepil treatment groups combined||0.039|-0.031|
72486628|NCT02109562|144501615|SUPERIORITY||Mean Difference (Final Values)|-6.148|STANDARD_ERROR_OF_MEAN|1.7261||0.0004|TWO_SIDED|95.0|-9.982|-2.314||For evaluation of treatment differences, compare against a 1-sided adjusted P value with significance at \<0.025. The P values have been adjusted for multiple comparisons using Dunnett's procedure.|repeated measure linear regression model||RBP-7000 90 mg - Placebo|Estimates, standard errors (SE), 2-sided confidence intervals (CIs), and -1-sided P values are based on a repeated-measures linear regression model of the change from baseline score, with fixed effects for visit as a categorical variable, baseline score, treatment and treatment by visit interaction, assuming an unstructured covariance matrix.||-2.314|-9.982|0.0004
72486629|NCT02109562|144501615|SUPERIORITY||Mean Difference (Final Values)|-7.237|STANDARD_ERROR_OF_MEAN|1.7141|<|0.0001|TWO_SIDED|95.0|-11.045|-3.429||For evaluation of treatment differences, compare against a 1-sided adjusted P value with significance at \<0.025. The P values have been adjusted for multiple comparisons using Dunnett's procedure.|repeated measure linear regression model||RBP-7000 120 mg - Placebo|Estimates, standard errors (SE), 2-sided confidence intervals (CIs), and -1-sided P values are based on a repeated-measures linear regression model of the change from baseline score, with fixed effects for visit as a categorical variable, baseline score, treatment and treatment by visit interaction, assuming an unstructured covariance matrix.||-3.429|-11.045|<0.0001
72486630|NCT02109562|144501616|SUPERIORITY||Mean Difference (Final Values)|-0.35|STANDARD_ERROR_OF_MEAN|0.0934||0.0002|TWO_SIDED|95.0|-0.557|-0.143||For evaluation of treatment differences, compare against a 1-sided adjusted P value with significance at \<0.025. The P values have been adjusted for multiple comparisons using Dunnett's procedure.|repeated measure linear regression model||RBP-7000 90 mg - Placebo|Estimates, standard errors (SE), 2-sided confidence intervals (CIs), and -1-sided P values are based on a repeated-measures linear regression model of the change from baseline score, with fixed effects for visit as a categorical variable, baseline score, treatment and treatment by visit interaction, assuming an unstructured covariance matrix.||-0.143|-0.557|0.0002
72486631|NCT02109562|144501616|SUPERIORITY||Mean Difference (Final Values)|-0.396|STANDARD_ERROR_OF_MEAN|0.0928|<|0.0001|TWO_SIDED|95.0|-0.602|-0.19||For evaluation of treatment differences, compare against a 1-sided adjusted P value with significance at \<0.025. The P values have been adjusted for multiple comparisons using Dunnett's procedure.|repeated measure linear regression model||RBP-7000 120 mg - Placebo|Estimates, standard errors (SE), 2-sided confidence intervals (CIs), and -1-sided P values are based on a repeated-measures linear regression model of the change from baseline score, with fixed effects for visit as a categorical variable, baseline score, treatment and treatment by visit interaction, assuming an unstructured covariance matrix.||-0.190|-0.602|<0.0001
72486632|NCT00688155|144501633|EQUIVALENCE|Two-sided test of mean differences from baseline.|Mean Difference (Net)|0.08|STANDARD_ERROR_OF_MEAN|0.25||0.66|TWO_SIDED|||||Physical activity training versus no physical activity training;|ANOVA|||Marginal comparisons of physical activity training vs no physical activity training||||0.66
72486633|NCT00688155|144501633|EQUIVALENCE|Two-sided tests of mean differences from baseline.|Mean Difference (Final Values)|-0.06|STANDARD_ERROR_OF_MEAN|0.26||0.55|TWO_SIDED|||||P-value for physical activity training is 0.55|ANOVA|||Marginal comparisons of physical activity training versus no physical activity training||||0.55
72486634|NCT00688155|144501633|EQUIVALENCE|Two Sided Test of Mean Difference from baseline|Mean Difference (Net)|0.02|STANDARD_ERROR_OF_MEAN|0.25||0.95|TWO_SIDED||||||ANOVA|||Marginal comparisons of cognitive training versus no cognitive training||||0.95
72402797|NCT01480076|144311694|SUPERIORITY_OR_OTHER|||||||0.1544|||||||mixed effect model|||Overall, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % work time missed due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.1544
72486635|NCT00688155|144501633|EQUIVALENCE|Two Sided Test of Mean Difference from baseline|Mean Difference (Net)|0.07|STANDARD_ERROR_OF_MEAN|0.26||0.48|TWO_SIDED||||||ANOVA|||Marginal comparisons of cognitive training versus no cognitive training||||0.48
72486636|NCT00688155|144501635|EQUIVALENCE|Two-sided tests of marginal means|Mean Difference (Final Values)|0.26|STANDARD_ERROR_OF_MEAN|0.29||0.23|TWO_SIDED||||||ANOVA|||Marginal comparisons of physical activity training versus no physical activity training.||||0.23
72486637|NCT00688155|144501635|EQUIVALENCE|Two Sided Test of Mean Difference from baseline|Mean Difference (Net)|-0.16|STANDARD_ERROR_OF_MEAN|0.29||0.42|TWO_SIDED||||||ANOVA|||Marginal comparisons of cognitive training versus no cognitive training||||0.42
72486638|NCT04136184|144501662|SUPERIORITY||Difference in LS Mean|-24.7593||||1e-08|TWO_SIDED|95.0|-30.9552|-18.5635|||MMRM|||||-18.5635|-30.9552|0.00000001
72513639|NCT03977727|144557993|SUPERIORITY||Mean Difference (Final Values)|-1.18||||0.968|TWO_SIDED|95.0|-10.32|9.99|||Mixed Models Analysis|||Linear mixed model was fit with therapy (Fiasp vs. NovoLog), period (Period 1 vs Period 2), and sequence (Fiasp/NovoLog vs NovoLog/Fiasp) as fixed effects. Subjects included as random effects.||9.99|-10.32|.968
72513640|NCT03977727|144557994|SUPERIORITY||Mean Difference (Final Values)|-0.06||||0.059|TWO_SIDED|95.0|-0.13|0.0|||Mixed Models Analysis|||Linear mixed model was fit with therapy (Fiasp vs. NovoLog), period (Period 1 vs Period 2), and sequence (Fiasp/NovoLog vs NovoLog/Fiasp) as fixed effects. Subjects included as random effects.||0|-.13|.059
72513641|NCT01627067|144558026|NON_INFERIORITY|The study terminated early due to lack of efficacy and funds only 22 patients were enrolled in the study. With 40 patients accrued at a rate of 2 patients per month, a one-sided alpha of 5%, and a post- accrual follow up of 3 months, we would have 80% power to detect a median PFS of 12 months as being statistically significantly higher than a historical control median PFS of 7 months.|Cox Proportional Hazard|0.25||||0.015|TWO_SIDED|95.0|0.08|0.76|||Regression, Cox|||Data for PFS were censored at the time of a patient's removal from study. With 40 patients accrued at a rate of 2 patients per month, a one-sided alpha of 5%, and a post- accrual follow up of 3 months, we would have 80% power to detect a median PFS of 12 months as being statistically significantly higher than a historical control median PFS of 7 months. The study terminated early due to lack of efficacy and funds only 22 patients were enrolled in the study.||0.76|0.08|0.015
72513642|NCT01627067|144558029|OTHER||Hazard Ratio (HR)|0.6||||0.31|TWO_SIDED|95.0|0.22|1.62|||Regression, Cox|||||1.62|0.22|0.31
72513643|NCT04146467|144558067|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||||||<0.0001
72513644|NCT04146467|144558069|SUPERIORITY||||||<|0.0004|||||||Fisher Exact|||||||<0.0004
72513645|NCT04146467|144558077|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||||||<0.0001
72513646|NCT05291949|144558089|OTHER|Bland-Altman|Bias|0.3|||||TWO_SIDED||||||Bland-Altman||||Lower 95% Limit of agreement (LoA) value = -0.34 Upper 95% LoA = 0.94|||
72513647|NCT01029886|144558105|NON_INFERIORITY_OR_EQUIVALENCE|Superiority of exenatide once weekly with respect to change in HbA1c was concluded if the upper limit of the 2-sided 95% confidence interval (CI) for the treatment difference (exenatide once weekly minus liraglutide) was less than zero. Non-inferiority was concluded if the upper limit of the CI was \<0.25%.|Least Squares Mean Difference|0.21|STANDARD_ERROR_OF_MEAN|0.07||0.002|TWO_SIDED|95.0|0.08|0.33|||Mixed Models Analysis|||A sample of 408 subjects in each treatment arm would provide approximately 90% power to detect a true difference between treatments of 0.25% in change in HbA1c from baseline with a 2 sided t-test at a significance level of 0.05, assuming a common standard deviation of 1.1%. MMRM model includes treatment, baseline HbA1c, HbA1c stratum, country, background OAD, week of visit, and treatment-by-week interaction as fixed effects and subject and error as random effects.||0.33|0.08|0.002
72513648|NCT01029886|144558106|SUPERIORITY_OR_OTHER|||||||0.011|TWO_SIDED|95.0|||||Cochran-Mantel-Haenszel|||Percentage of patients achieving HbA1c \<7.0% at Week 26 were compared between treatments using a Cochran-Mantel-Haenszel test, in which HbA1c stratum, country, and background OAD served as stratification factors.||||0.011
72486639|NCT04136184|144501663|SUPERIORITY||Difference in LS Mean|-19.7352||||1e-08|TWO_SIDED|95.0|-25.6301|-13.8403|||MMRM|||||-13.8403|-25.6301|0.00000001
72486640|NCT04136184|144501664|SUPERIORITY||Difference in LS Mean|-70.42||||1e-08|TWO_SIDED|95.0|-75.17|-65.66|||MMRM|||||-65.66|-75.17|0.00000001
72486641|NCT04136184|144501665|SUPERIORITY||Difference in LS Mean|-66.65||||1e-08|TWO_SIDED|95.0|-71.59|-61.71|||MMRM|||||-61.71|-71.59|0.00000001
72486642|NCT04136184|144501666|SUPERIORITY||Difference in LS Mean|-9.3542||||0.00012203|TWO_SIDED|95.0|-13.8691|-4.8394|||MMRM|||||-4.8394|-13.8691|0.00012203
72486643|NCT04136184|144501667|SUPERIORITY||Difference in LS Mean|-11.8202||||1.873e-05|TWO_SIDED|95.0|-16.8927|-6.7477|||MMRM|||||-6.7477|-16.8927|0.00001873
72486644|NCT04136184|144501668|SUPERIORITY||Difference in LS Mean|-3.94||||0.00052447|TWO_SIDED|95.0|-6.08|-1.8|||MMRM|||Week 35||-1.80|-6.08|0.00052447
72486645|NCT04136184|144501668|SUPERIORITY||Difference in LS Mean|-8.21||||1e-08|TWO_SIDED|95.0|-10.65|-5.76|||MMRM|||Week 66||-5.76|-10.65|0.00000001
72486646|NCT04136184|144501669|SUPERIORITY||Difference in LS Mean|5.305||||5.58e-06|TWO_SIDED|95.0|3.195|7.416|||MMRM|||||7.416|3.195|0.00000558
72486647|NCT04136184|144501670|SUPERIORITY||Difference in LS Mean|-0.2||||0.02407897|TWO_SIDED|95.0|-0.4|0.0|||MMRM|||||-0.0|-0.4|0.02407897
72486648|NCT04136184|144501671|SUPERIORITY||Difference in LS Mean|82.6991||||2e-07|TWO_SIDED|95.0|54.6431|110.7551|||MMRM|||||110.7551|54.6431|0.00000020
72513649|NCT01029886|144558107|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.36|STANDARD_ERROR_OF_MEAN|0.15||0.021|TWO_SIDED|95.0|0.05|0.66|||Mixed Models Analysis|||MMRM model includes treatment, baseline fasting serum glucose, HbA1c stratum, country, background OAD, week of visit, and treatment-by-week interaction as fixed effects and subject and error as random effects.||0.66|0.05|0.021
72513650|NCT01029886|144558108|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.9|STANDARD_ERROR_OF_MEAN|0.26|<|0.001|TWO_SIDED|95.0|0.39|1.4|||Mixed Models Analysis|||MMRM model includes treatment, baseline body weight, HbA1c stratum, country, background OAD, week of visit, and treatment-by-week interaction as fixed effects and subject and error as random effects.||1.40|0.39|<.001
72567904|NCT02037165|144667467|SUPERIORITY_OR_OTHER||adjusted mean difference|2.53|STANDARD_ERROR_OF_MEAN|2.079|||TWO_SIDED|95.0|-1.6|6.6|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 3:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||6.6|-1.6|
72402798|NCT01480076|144311694|SUPERIORITY_OR_OTHER|||||||0.0167|||||||mixed effect model|||Overall, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % work time missed due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0167
72402799|NCT01480076|144311694|SUPERIORITY_OR_OTHER|||||||0.3868|||||||mixed effect model|||Overall, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % work time missed due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.3868
72513651|NCT01029886|144558109|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.09|STANDARD_ERROR_OF_MEAN|0.05||0.079|TWO_SIDED|95.0|-0.01|0.19|||Mixed Models Analysis|||MMRM model includes treatment, baseline total cholesterol, HbA1c stratum, country, background OAD, week of visit, and treatment-by-week interaction as fixed effects and subject and error as random effects.||0.19|-0.01|0.079
72513652|NCT01029886|144558110|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.01||0.832|TWO_SIDED|95.0|-0.02|0.02|||Mixed Models Analysis|||MMRM model includes treatment, baseline HDL-C, HbA1c stratum, country, background OAD, week of visit, and treatment-by-week interaction as fixed effects and subject and error as random effects.||0.02|-0.02|0.832
72513653|NCT01029886|144558111|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|1.09|STANDARD_ERROR_OF_MEAN|0.03|<|0.001|TWO_SIDED|95.0|1.04|1.15|||Mixed Models Analysis|||Fasting triglycerides were logarithm-transformed and the change at Week 26 to baseline, expressed as the ratio, was analyzed using a MMRM model with treatment, baseline fasting triglycerides, HbA1c stratum, country, background OAD, week of visit, and treatment-by-week interaction as fixed effects and subject and error as random effects.||1.15|1.04|<.001
72513654|NCT01029886|144558112|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.97|STANDARD_ERROR_OF_MEAN|0.76||0.205|TWO_SIDED|95.0|-0.53|2.47|||Mixed Models Analysis|||MMRM model includes treatment, baseline SBP, HbA1c stratum, country, background OAD, week of visit, and treatment-by-week interaction as fixed effects and subject and error as random effects.||2.47|-0.53|0.205
72513655|NCT01029886|144558113|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.5||0.981|TWO_SIDED|95.0|-0.96|0.98|||Mixed Models Analysis|||MMRM model includes treatment, baseline DBP, HbA1c stratum, country, background OAD, week of visit, and treatment-by-week interaction as fixed effects and subject and error as random effects.||0.98|-0.96|0.981
72513656|NCT01778127|144558115|SUPERIORITY_OR_OTHER|||||||0.9|TWO_SIDED||||||t-test, 2 sided|||||||0.90
72513657|NCT01778127|144558115|SUPERIORITY_OR_OTHER|||||||0.18|TWO_SIDED||||||t-test, 2 sided|||||||0.18
72513658|NCT01778127|144558115|SUPERIORITY_OR_OTHER|||||||0.14|TWO_SIDED||||||t-test, 2 sided|||||||0.14
72513659|NCT01778127|144558116|SUPERIORITY_OR_OTHER|||||||0.49|TWO_SIDED||||||t-test, 2 sided|||||||0.49
72513660|NCT01778127|144558116|SUPERIORITY_OR_OTHER|||||||0.84|TWO_SIDED||||||t-test, 2 sided|||||||0.84
72513661|NCT01778127|144558116|SUPERIORITY_OR_OTHER|||||||0.37|TWO_SIDED||||||t-test, 2 sided|||||||0.37
72576986|NCT00261443|144680735|SUPERIORITY_OR_OTHER_LEGACY|||||||0.034||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Baseline Lactate Dehydrogenase||||0.034
72513662|NCT01778127|144558117|SUPERIORITY_OR_OTHER|||||||0.03|TWO_SIDED||||||t-test, 2 sided|||||||0.03
72513663|NCT01778127|144558117|SUPERIORITY_OR_OTHER|||||||0.63|TWO_SIDED||||||t-test, 2 sided|||||||0.63
72513664|NCT01778127|144558117|SUPERIORITY_OR_OTHER|||||||0.09|TWO_SIDED||||||t-test, 2 sided|||||||0.09
72513665|NCT01778127|144558118|SUPERIORITY_OR_OTHER|||||||0.49|TWO_SIDED||||||t-test, 2 sided|||||||0.49
72513666|NCT01778127|144558118|SUPERIORITY_OR_OTHER|||||||0.43|TWO_SIDED||||||t-test, 2 sided|||||||0.43
72513667|NCT01778127|144558118|SUPERIORITY_OR_OTHER|||||||0.89|TWO_SIDED||||||t-test, 2 sided|||||||0.89
72513668|NCT01778127|144558119|SUPERIORITY_OR_OTHER|||||||0.61|TWO_SIDED||||||t-test, 2 sided|||||||0.61
72513669|NCT01778127|144558119|SUPERIORITY_OR_OTHER|||||||0.64|TWO_SIDED||||||t-test, 2 sided|||||||0.64
72513670|NCT01778127|144558119|SUPERIORITY_OR_OTHER|||||||0.99|TWO_SIDED||||||t-test, 2 sided|||||||0.99
72513671|NCT01778127|144558120|SUPERIORITY_OR_OTHER|||||||0.69|TWO_SIDED||||||t-test, 2 sided|||||||0.69
72513672|NCT01778127|144558120|SUPERIORITY_OR_OTHER|||||||0.89|TWO_SIDED||||||t-test, 2 sided|||||||0.89
72513673|NCT01778127|144558120|SUPERIORITY_OR_OTHER|||||||0.59|TWO_SIDED||||||t-test, 2 sided|||||||0.59
72513674|NCT01778127|144558121|SUPERIORITY_OR_OTHER|||||||0.78|TWO_SIDED||||||t-test, 2 sided|||||||0.78
72513675|NCT01778127|144558121|SUPERIORITY_OR_OTHER|||||||0.95|TWO_SIDED||||||t-test, 2 sided|||||||0.95
72513676|NCT01778127|144558121|SUPERIORITY_OR_OTHER|||||||0.83|TWO_SIDED||||||t-test, 2 sided|||||||0.83
72513677|NCT01778127|144558122|SUPERIORITY_OR_OTHER|||||||0.83|TWO_SIDED||||||t-test, 2 sided|||||||0.83
72513678|NCT01778127|144558122|SUPERIORITY_OR_OTHER|||||||0.83|TWO_SIDED||||||t-test, 2 sided|||||||0.83
72513679|NCT01778127|144558122|SUPERIORITY_OR_OTHER|||||||0.99|TWO_SIDED||||||t-test, 2 sided|||||||0.99
72513680|NCT01778127|144558123|SUPERIORITY_OR_OTHER|||||||0.44|TWO_SIDED||||||t-test, 2 sided|||||||0.44
72513681|NCT01778127|144558123|SUPERIORITY_OR_OTHER|||||||0.19|TWO_SIDED||||||t-test, 2 sided|||||||0.19
72513682|NCT01778127|144558123|SUPERIORITY_OR_OTHER|||||||0.54|TWO_SIDED||||||t-test, 2 sided|||||||0.54
72513683|NCT01778127|144558124|SUPERIORITY_OR_OTHER|||||||0.17|TWO_SIDED||||||t-test, 2 sided|||||||0.17
72513684|NCT01778127|144558124|SUPERIORITY_OR_OTHER|||||||0.13|TWO_SIDED||||||t-test, 2 sided|||||||0.13
72513685|NCT01778127|144558124|SUPERIORITY_OR_OTHER|||||||0.81|TWO_SIDED||||||t-test, 2 sided|||||||0.81
72576987|NCT00261443|144680735|SUPERIORITY_OR_OTHER_LEGACY|||||||0.091||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Highest Value of Change in Lactate Dehydrogenase During Phase 3||||0.091
72486649|NCT03734016|144501709|NON_INFERIORITY|Non-inferiority testing for ORR was performed using a stratified Wald test based on the stratified Mantel-Haenszel response ratio estimate against the non-inferiority margin of 0.8558 on the log scale.|Response ratio|1.12|||<|0.0001|TWO_SIDED|95.0|1.04|1.22|||Stratified Wald test|Stratified by the randomization stratification factors (age, geographic region, refractory status, and 17p deletion and TP53 mutation status)|Response ratio is the estimated ratio of the overall response rate of the zanubrutinib arm divided by that of the ibrutinib arm.|||1.22|1.04|<0.0001
72486650|NCT03734016|144501709|SUPERIORITY|||||||0.0035||||||Superiority testing was performed using a 2-sided stratified Cochran-Mantel-Haenszel test.|Cochran-Mantel-Haenszel|Stratified by the randomization stratification factors (age, geographic region, refractory status, and 17p deletion and TP53 mutation status)||||||0.0035
72486651|NCT03734016|144501710|NON_INFERIORITY|Non-inferiority testing for ORR was performed using a stratified Wald test based on the stratified Mantel-Haenszel response ratio estimate against the non-inferiority margin of 0.8558 on the log scale.|Response ratio|1.14|||<|0.0001|TWO_SIDED|95.0|1.05|1.22|||Stratified Wald test|Stratified by the randomization stratification factors (age, geographic region, refractory status, and 17p deletion and TP53 mutation status)|Response ratio is the estimated ratio of the overall response rate of the zanubrutinib arm divided by that of the ibrutinib arm.|||1.22|1.05|<0.0001
72486652|NCT03734016|144501710|SUPERIORITY|Superiority testing was performed using a 2-sided stratified Cochran-Mantel-Haenszel test.||||||0.0007|||||||Cochran-Mantel-Haenszel|Stratified by the randomization stratification factors (age, geographic region, refractory status, and 17p deletion and TP53 mutation status)||||||0.0007
72486653|NCT03734016|144501711|NON_INFERIORITY|Non-inferiority was tested with a non-inferiority margin (hazard ratio) of 1.33 with the use of a stratified Wald test based on the four randomization stratification factors.|Hazard Ratio (HR)|0.65|||<|0.0001|TWO_SIDED|95.0|0.49|0.86|||Stratified Wald test|Stratified by the randomization stratification factors (age, geographic region, refractory status, and 17p deletion and TP53 mutation status)|Hazard ratio is the ratio of the hazard of the zanubrutinib arm divided by that of the ibrutinib arm.|||0.86|0.49|<0.0001
72486654|NCT03734016|144501711|SUPERIORITY|||||||0.0024|||||||Stratified Log-rank test|Stratified by the randomization stratification factors (age, geographic region, refractory status, and 17p deletion and TP53 mutation status)||||||0.0024
72486655|NCT03734016|144501712|NON_INFERIORITY|Noninferiority was tested with a noninferiority margin (hazard ratio) of 1.33 with the use of a stratified Wald test based on the four randomization stratification factors.|Hazard Ratio (HR)|0.65|||<|0.0001|TWO_SIDED|95.0|0.49|0.86||Stratified by the randomization stratification factors (age, geographic region, refractory status, and 17p deletion and TP53 mutation status)|Stratified Wald test||Hazard ratio is the ratio of the hazard of the zanubrutinib arm divided by that of the ibrutinib arm.|||0.86|0.49|<0.0001
72486656|NCT03734016|144501712|SUPERIORITY|||||||0.0024|||||||Stratified Log-rank test|Stratified by the randomization stratification factors (age, geographic region, refractory status, and 17p deletion and TP53 mutation status)||||||0.0024
72513686|NCT01778127|144558125|SUPERIORITY_OR_OTHER|||||||0.08|TWO_SIDED||||||t-test, 2 sided|||||||0.08
72513687|NCT01778127|144558125|SUPERIORITY_OR_OTHER|||||||0.15|TWO_SIDED||||||t-test, 2 sided|||||||0.15
72513688|NCT01778127|144558125|SUPERIORITY_OR_OTHER|||||||0.83|TWO_SIDED||||||t-test, 2 sided|||||||0.83
72486657|NCT03734016|144501713|SUPERIORITY||Rate Difference|-8.0||||0.0004|TWO_SIDED|95.0|-12.4|-3.6|||Chi-squared||Rate difference is the zanubrutinib rate minus the ibrutinib rate.|||-3.6|-12.4|0.0004
72486658|NCT03734016|144501716|OTHER||Hazard Ratio (HR)|0.54|||||TWO_SIDED|95.0|0.41|0.72|||||Hazard ratio is the ratio of the hazard of the zanubrutinib arm divided by that of the ibrutinib arm.|||0.72|0.41|
72486659|NCT03734016|144501719|OTHER||Hazard Ratio (HR)|0.76|||||TWO_SIDED|95.0|0.51|1.11|||||Hazard ratio is the ratio of the hazard of the zanubrutinib arm divided by that of the ibrutinib arm.|||1.11|0.51|
72486660|NCT03734016|144501720|OTHER||Least Squares (LS) Mean Difference|3.0||||0.0338|TWO_SIDED|95.0|0.23|5.77|||Mixed model for repeated measures (MMRM)|||Analysis of Change from Baseline in EORTC QLQ-C30 GHS/QOL at Week 24. A linear mixed model for repeated measures (MMRM) includes the repeated measurement of the change from baseline as the dependent variable, and the treatment arm by assessment timepoint interaction, and baseline score as a covariate with an unstructured covariance matrix.||5.77|0.23|0.0338
72486661|NCT03734016|144501720|OTHER||LS Mean Difference|1.34||||0.3304|TWO_SIDED|95.0|-1.37|4.06|||Mixed model for repeated measures (MMRM)|||Analysis of Change from Baseline in EORTC QLQ-C30 GHS/QOL at Week 48. A linear mixed model for repeated measures (MMRM) includes the repeated measurement of the change from baseline as the dependent variable, and the treatment arm by assessment timepoint interaction, and baseline score as a covariate with an unstructured covariance matrix.||4.06|-1.37|0.3304
72486662|NCT03734016|144501720|OTHER||LS Mean Difference|1.82||||0.1189|TWO_SIDED|95.0|-0.47|4.12|||Mixed model for repeated measures (MMRM)|||"Analysis of Change from Baseline in EORTC QLQ-C30 Physical Functioning Scale at Week 24.~A linear mixed model for repeated measures (MMRM) includes the repeated measurement of the change from baseline as the dependent variable, and the treatment arm by assessment timepoint interaction, and baseline score as a covariate with an unstructured covariance matrix."||4.12|-0.47|0.1189
72513689|NCT01778127|144558126|SUPERIORITY_OR_OTHER|||||||0.05|TWO_SIDED||||||t-test, 2 sided|||||||0.05
72513690|NCT01778127|144558126|SUPERIORITY_OR_OTHER|||||||0.11|TWO_SIDED||||||t-test, 2 sided|||||||0.11
72513691|NCT01778127|144558126|SUPERIORITY_OR_OTHER|||||||0.81|TWO_SIDED||||||t-test, 2 sided|||||||0.81
72513692|NCT03259490|144558147|OTHER||Adjusted gmean ratio T/R (%)|103.06|STANDARD_DEVIATION|5.8|||TWO_SIDED|95.0|100.36|105.83|||ANOVA|Analysis of Variance (ANOVA) on the logarithmic scale including effects for 'sequence', 'subjects within sequences', 'period', and 'treatment'.|The standard deviation is actually intra-individual geometric co-efficient of variation (gCV)|The assessment of bioequivalence was based upon two-sided 90% confidence intervals (CIs) for the ratios of the geometric means (test/reference) for the endpoints using an acceptance range of 80.00 to 125.00%.||105.83|100.36|
72576988|NCT00261443|144680736|SUPERIORITY_OR_OTHER_LEGACY|||||||0.808||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Baseline LDL Cholesterol (fasting)||||0.808
72513693|NCT03259490|144558148|OTHER||Adjusted gmean ratio T/R (%)|100.35|STANDARD_DEVIATION|9.5|||TWO_SIDED|95.0|96.11|104.77|||ANOVA|Analysis of Variance (ANOVA) on the logarithmic scale including effects for 'sequence', 'subjects within sequences', 'period', and 'treatment'.|The standard deviation is actually intra-individual geometric co-efficient of variation (gCV)|The assessment of bioequivalence was based upon two-sided 90% confidence intervals (CIs) for the ratios of the geometric means (test/reference) for the endpoints using an acceptance range of 80.00 to 125.00%.||104.77|96.11|
72513694|NCT03259490|144558149|OTHER||Adjusted gmean ratio T/R (%)|100.31|STANDARD_DEVIATION|8.2|||TWO_SIDED|95.0|96.65|104.1|||ANOVA|Analysis of Variance (ANOVA) on the logarithmic scale including effects for 'sequence', 'subjects within sequences', 'period', and 'treatment'.|The standard deviation is actually intra-individual geometric co-efficient of variation (gCV)|The assessment of bioequivalence was based upon two-sided 90% confidence intervals (CIs) for the ratios of the geometric means (test/reference) for the endpoints using an acceptance range of 80.00 to 125.00%.||104.10|96.65|
72513695|NCT03259490|144558150|OTHER||Adjusted gmean ratio T/R (%)|99.95|STANDARD_DEVIATION|12.4|||TWO_SIDED|95.0|94.52|105.7|||ANOVA|Analysis of Variance (ANOVA) on the logarithmic scale including effects for 'sequence', 'subjects within sequences', 'period', and 'treatment'.|The standard deviation is actually intra-individual geometric co-efficient of variation (gCV)|The assessment of bioequivalence was based upon two-sided 90% confidence intervals (CIs) for the ratios of the geometric means (test/reference) for the endpoints using an acceptance range of 80.00 to 125.00%.||105.70|94.52|
72513696|NCT03259490|144558151|OTHER||Adjusted gmean ratio T/R (%)|107.78|STANDARD_DEVIATION|11.0|||TWO_SIDED|95.0|102.52|113.31|||ANOVA|Analysis of Variance (ANOVA) on the logarithmic scale including effects for 'sequence', 'subjects within sequences', 'period', and 'treatment'.|The standard deviation is actually intra-individual geometric co-efficient of variation (gCV)|The assessment of bioequivalence was based upon two-sided 90% confidence intervals (CIs) for the ratios of the geometric means (test/reference) for the endpoints using an acceptance range of 80.00 to 125.00%.||113.31|102.52|
72513697|NCT03259490|144558152|OTHER||Adjusted gmean ratio T/R (%)|97.17|STANDARD_DEVIATION|10.6|||TWO_SIDED|95.0|92.63|101.93|||ANOVA|Analysis of Variance (ANOVA) on the logarithmic scale including effects for 'sequence', 'subjects within sequences', 'period', and 'treatment'.|The standard deviation is actually intra-individual geometric co-efficient of variation (gCV)|The assessment of bioequivalence was based upon two-sided 90% confidence intervals (CIs) for the ratios of the geometric means (test/reference) for the endpoints using an acceptance range of 80.00 to 125.00%.||101.93|92.63|
72513698|NCT03259490|144558153|OTHER||Adjusted gmean ratio T/R (%)|103.11|STANDARD_DEVIATION|5.9|||TWO_SIDED|95.0|100.38|105.92|||ANOVA|Analysis of Variance (ANOVA) on the logarithmic scale including effects for 'sequence', 'subjects within sequences', 'period', and 'treatment'.|The standard deviation is actually intra-individual geometric co-efficient of variation (gCV)|The assessment of bioequivalence was based upon two-sided 90% confidence intervals (CIs) for the ratios of the geometric means (test/reference) for the endpoints using an acceptance range of 80.00 to 125.00%.||105.92|100.38|
72513699|NCT03259490|144558154|OTHER||Adjusted gmean ratio T/R (%)|100.17|STANDARD_DEVIATION|10.1|||TWO_SIDED|95.0|95.68|104.86|||ANOVA|Analysis of Variance (ANOVA) on the logarithmic scale including effects for 'sequence', 'subjects within sequences', 'period', and 'treatment'.|The standard deviation is actually intra-individual geometric co-efficient of variation (gCV)|The assessment of bioequivalence was based upon two-sided 90% confidence intervals (CIs) for the ratios of the geometric means (test/reference) for the endpoints using an acceptance range of 80.00 to 125.00%.||104.86|95.68|
72513700|NCT03259490|144558155|OTHER||Adjusted gmean ratio T/R (%)|97.3|STANDARD_DEVIATION|13.2|||TWO_SIDED|95.0|91.65|103.29|||ANOVA|Analysis of Variance (ANOVA) on the logarithmic scale including effects for 'sequence', 'subjects within sequences', 'period', and 'treatment'.|The standard deviation is actually intra-individual geometric co-efficient of variation (gCV)|The assessment of bioequivalence was based upon two-sided 90% confidence intervals (CIs) for the ratios of the geometric means (test/reference) for the endpoints using an acceptance range of 80.00 to 125.00%.||103.29|91.65|
72576989|NCT00261443|144680736|SUPERIORITY_OR_OTHER_LEGACY|||||||0.507||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Change from Baseline at Week 52 (LOCF)||||0.507
72576990|NCT00261443|144680736|SUPERIORITY_OR_OTHER_LEGACY|||||||0.948||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Highest Change Value in LDL Cholesterol (fasting)||||0.948
72576991|NCT00261443|144680737|SUPERIORITY_OR_OTHER_LEGACY|||||||0.967||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Baseline Neutrophils (relative)||||0.967
72576992|NCT00261443|144680737|SUPERIORITY_OR_OTHER_LEGACY|||||||0.486||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison in change from Baseline in Neutrophils (relative) at Week 52 (LOCF)||||0.486
72576993|NCT00261443|144680737|SUPERIORITY_OR_OTHER_LEGACY|||||||0.323||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Highest Value of Change in Neutrophils (relative), Phase 3 Safety Sample||||0.323
72576994|NCT00261443|144680738|SUPERIORITY_OR_OTHER_LEGACY|||||||0.663||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Baseline in Platelet Count||||0.663
72576995|NCT00261443|144680738|SUPERIORITY_OR_OTHER_LEGACY|||||||0.322||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Change from Baseline at Week 52 (LOCF)||||0.322
72576996|NCT00261443|144680738|SUPERIORITY_OR_OTHER_LEGACY|||||||0.358||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Highest Value of Change in Platelet Count, Phase 3 Safety Sample||||0.358
72576997|NCT00261443|144680738|SUPERIORITY_OR_OTHER_LEGACY|||||||0.541||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Lowest Value of Change in Platelet Count, Phase 3 Safety Sample||||0.541
72576998|NCT00261443|144680739|SUPERIORITY_OR_OTHER_LEGACY|||||||0.412||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Baseline Prolactin||||0.412
72576999|NCT00261443|144680739|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison, Change from Baseline at Week 52 (LOCF)||||<0.001
72486663|NCT03734016|144501720|OTHER||LS Mean Difference|1.15||||0.3274|TWO_SIDED|95.0|-1.15|3.44|||Mixed model for repeated measures (MMRM)|||"Analysis of Change from Baseline in EORTC QLQ-C30 Physical Functioning Scale at Week 48.~A linear mixed model for repeated measures (MMRM) includes the repeated measurement of the change from baseline as the dependent variable, and the treatment arm by assessment timepoint interaction, and baseline score as a covariate with an unstructured covariance matrix."||3.44|-1.15|0.3274
72486664|NCT03734016|144501720|OTHER||LS Mean Difference|0.63||||0.6821|TWO_SIDED|95.0|-2.4|3.66|||Mixed model for repeated measures (MMRM)|||"Analysis of Change from Baseline in EORTC QLQ-C30 Role Functioning Scale at Week 24.~A linear mixed model for repeated measures (MMRM) includes the repeated measurement of the change from baseline as the dependent variable, and the treatment arm by assessment timepoint interaction, and baseline score as a covariate with an unstructured covariance matrix."||3.66|-2.40|0.6821
72486665|NCT03734016|144501720|OTHER||LS Mean Difference|1.8||||0.2701|TWO_SIDED|95.0|-1.4|5.0|||Mixed model for repeated measures (MMRM)|||"Analysis of Change from Baseline in EORTC QLQ-C30 Role Functioning Scale at Week 48.~A linear mixed model for repeated measures (MMRM) includes the repeated measurement of the change from baseline as the dependent variable, and the treatment arm by assessment timepoint interaction, and baseline score as a covariate with an unstructured covariance matrix."||5.00|-1.40|0.2701
72486666|NCT03734016|144501721|OTHER||LS Mean Difference|-1.91||||0.1778|TWO_SIDED|95.0|-4.7|0.87|||Mixed model for repeated measures (MMRM)|||"Analysis of Change from Baseline in EORTC QLQ-C30 Fatigue Symptom Scale at Week 24.~A linear mixed model for repeated measures (MMRM) includes the repeated measurement of the change from baseline as the dependent variable, and the treatment arm by assessment timepoint interaction, and baseline score as a covariate with an unstructured covariance matrix."||0.87|-4.70|0.1778
72486667|NCT03734016|144501721|OTHER||LS Mean Difference|-0.35||||0.8174|TWO_SIDED|95.0|-3.32|2.62|||Mixed model for repeated measures (MMRM)|||"Analysis of Change from Baseline in EORTC QLQ-C30 Fatigue Symptom Scale at Week 48.~A linear mixed model for repeated measures (MMRM) includes the repeated measurement of the change from baseline as the dependent variable, and the treatment arm by assessment timepoint interaction, and baseline score as a covariate with an unstructured covariance matrix."||2.62|-3.32|0.8174
72486668|NCT03734016|144501721|OTHER||LS Mean Difference|-0.29||||0.6294|TWO_SIDED|95.0|-1.48|0.89|||Mixed model for repeated measures (MMRM)|||"Analysis of Change from Baseline in EORTC QLQ-C30 Nausea and Vomiting Symptom Scale at Week 24.~A linear mixed model for repeated measures (MMRM) includes the repeated measurement of the change from baseline as the dependent variable, and the treatment arm by assessment timepoint interaction, and baseline score as a covariate with an unstructured covariance matrix."||0.89|-1.48|0.6294
72486669|NCT03734016|144501721|OTHER||LS Mean Difference|-0.51||||0.4933|TWO_SIDED|95.0|-1.99|0.96|||Mixed model for repeated measures (MMRM)|||"Analysis of Change from Baseline in EORTC QLQ-C30 Nausea and Vomiting Symptom Scale at Week 48.~A linear mixed model for repeated measures (MMRM) includes the repeated measurement of the change from baseline as the dependent variable, and the treatment arm by assessment timepoint interaction, and baseline score as a covariate with an unstructured covariance matrix."||0.96|-1.99|0.4933
72486670|NCT03734016|144501721|OTHER||LS Mean Difference|-1.43||||0.3643|TWO_SIDED|95.0|-4.51|1.66|||Mixed model for repeated measures (MMRM)|||"Analysis of Change from Baseline in EORTC QLQ-C30 Pain Symptom Scale at Week 24.~A linear mixed model for repeated measures (MMRM) includes the repeated measurement of the change from baseline as the dependent variable, and the treatment arm by assessment timepoint interaction, and baseline score as a covariate with an unstructured covariance matrix."||1.66|-4.51|0.3643
72513701|NCT01963208|144558156|OTHER||Median Difference (Final Values)|-7.06||||0.1788|TWO_SIDED|95.0|-17.44|3.52||The null hypothesis is that there is no difference between the distributions of the two treatment groups with respect to percent change in seizure frequency.|Rank ANCOVA|||||3.52|-17.44|0.1788
72513702|NCT05301322|144558218|NON_INFERIORITY|Noninferiority was declared if the lower limit of the 2-sided 95% CI for the GMR (Coadministration Group to Sequential-Administration Group) was greater than 0.667 for both RSV A and RSV B NTs.|GMR|0.86|||||TWO_SIDED|95.0|0.785|0.951|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences of the logarithms of the titers (Coadministration minus Sequential-Administration) and the corresponding CIs (based on Student's t distribution).|RSV A||0.951|0.785|
72513703|NCT05301322|144558218|NON_INFERIORITY|Noninferiority was declared if the lower limit of the 2-sided 95% CI for the GMR (Coadministration Group to Sequential-Administration Group) was greater than 0.667 for both RSV A and RSV B NTs.|GMR|0.85|||||TWO_SIDED|95.0|0.766|0.943|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences of the logarithms of the titers (Coadministration minus Sequential-Administration) and the corresponding CIs (based on Student's t distribution).|RSV B||0.943|0.766|
72577000|NCT00261443|144680739|SUPERIORITY_OR_OTHER_LEGACY|||||||0.004||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Highest Value of Change in Prolactin, Phase 3 Safety Sample||||0.004
72486671|NCT03734016|144501721|OTHER||LS Mean Difference|-2.43||||0.1363|TWO_SIDED|95.0|-5.62|0.77|||Mixed model for repeated measures (MMRM)|||"Analysis of Change from Baseline in EORTC QLQ-C30 Pain Symptom Scale at Week 48.~A linear mixed model for repeated measures (MMRM) includes the repeated measurement of the change from baseline as the dependent variable, and the treatment arm by assessment timepoint interaction, and baseline score as a covariate with an unstructured covariance matrix."||0.77|-5.62|0.1363
72486672|NCT03734016|144501721|OTHER||LS Mean Difference|-1.59||||0.2001|TWO_SIDED|95.0|-4.01|0.84|||Mixed model for repeated measures (MMRM)|||"Analysis of Change from Baseline in EORTC QLQ-C30 Diarrhoea Symptom Scale at Week 24.~A linear mixed model for repeated measures (MMRM) includes the repeated measurement of the change from baseline as the dependent variable, and the treatment arm by assessment timepoint interaction, and baseline score as a covariate with an unstructured covariance matrix."||0.84|-4.01|0.2001
72486673|NCT03734016|144501721|OTHER||LS Mean Difference|-1.85||||0.1121|TWO_SIDED|95.0|-4.12|0.43|||Mixed model for repeated measures (MMRM)|||"Analysis of Change from Baseline in EORTC QLQ-C30 Diarrhoea Symptom Scale at Week 48.~A linear mixed model for repeated measures (MMRM) includes the repeated measurement of the change from baseline as the dependent variable, and the treatment arm by assessment timepoint interaction, and baseline score as a covariate with an unstructured covariance matrix."||0.43|-4.12|0.1121
72486674|NCT00418665|144501758|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.6||||||95.0|0.07|5.136|||||Romiplostim/placebo|||5.136|0.070|
72577001|NCT00261443|144680740|SUPERIORITY_OR_OTHER_LEGACY|||||||0.63||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Baseline Total Bilirubin||||0.630
72486675|NCT00418665|144501758|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.154||||||95.0|0.022|1.071|||||Romiplostim/placebo|||1.071|0.022|
72486676|NCT00418665|144501759|SUPERIORITY_OR_OTHER||Odds Ratio, log|0.154||||||95.0|0.022|1.071|||||Romiplostim/placebo|||1.071|0.022|
72486677|NCT00418665|144501759|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.514||||||95.0|0.102|2.589|||||Romiplostim/placebo|||2.589|0.102|
72486678|NCT00418665|144501760|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.0||||||95.0|0.227|39.608|||||Romiplostim/placebo|||39.608|0.227|
72486679|NCT00418665|144501760|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.714||||||95.0|0.144|20.473|||||Romiplostim/placebo|||20.473|0.144|
72486680|NCT00418665|144501761|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.911||||||95.0|0.097|8.529|||||Romiplostim/placebo|||8.529|0.097|
72486681|NCT00418665|144501761|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.866||||||95.0|0.175|4.278|||||Romiplostim/placebo|||4.278|0.175|
72486682|NCT03227471|144501797|OTHER|||||||0.9943||||||P value within treatment|Mixed-effects model for repeated measure|||||||0.9943
72486683|NCT03227471|144501797|OTHER||||||<|0.0001||||||P value within treatment|Mixed-effects model for repeated measure|||||||<0.0001
72486684|NCT03227471|144501797|OTHER||||||<|0.0001||||||P value within treatment|Mixed-effects model for repeated measure|||||||< 0.0001
72486685|NCT03227471|144501797|OTHER||||||<|0.0001||||||P value within treatment|Mixed-effects model for repeated measure|||||||<0.0001
72486686|NCT03227471|144501798|OTHER|||||||0.8869||||||P value within treatment.|Mixed-effects model for repeated measure|||||||0.8869
72486687|NCT03227471|144501798|OTHER||||||<|0.0001||||||P value within treatment|Mixed-effects model for repeated measure|||||||<0.0001
72486688|NCT03227471|144501799|OTHER|||||||0.6407||||||P value within treatment|Mixed-effects model for repeated measure|||||||0.6407
72486689|NCT03227471|144501799|OTHER||||||<|0.0001||||||P value within treatment.|mixed-effects model for repeated measure|||||||<0.0001
72486690|NCT03227471|144501814|OTHER|||||||0.5802||||||P value within treatment. These are nominal p-values without multiplicity control.|Mixed-effects model for repeated measure|||||||0.5802
72486691|NCT03227471|144501814|OTHER||||||<|0.0001||||||P value within treatment. These are nominal p-values without multiplicity control.|Mixed-effects model for repeated measure|||||||<0.0001
72486692|NCT03227471|144501814|OTHER||||||<|0.0001||||||P value within treatment. These are nominal p-values without multiplicity control.|Mixed-effects model for repeated measure|||||||<0.0001
72486693|NCT03227471|144501814|OTHER||||||<|0.0001||||||P value within treatment. These are nominal p-values without multiplicity control.|Mixed-effects model for repeated measure|||||||<0.0001
72486694|NCT03227471|144501815|OTHER|||||||0.8712||||||P value within treatment. These are nominal p-values without multiplicity control.|mixed-effects model for repeated measure|||||||0.8712
72486695|NCT03227471|144501815|OTHER||||||<|0.0001||||||P value within treatment. These are nominal p-values without multiplicity control.|mixed-effects model for repeated measure|||||||<0.0001
72486696|NCT03227471|144501816|OTHER|||||||0.8359||||||P value within treatment. These are nominal p-values without multiplicity control.|mixed-effects model for repeated measure|||||||0.8359
72486697|NCT03227471|144501816|OTHER||||||<|0.0001||||||P value within treatment. These are nominal p-values without multiplicity control.|mixed-effects model for repeated measure|||||||<0.0001
72486698|NCT03227471|144501817|OTHER|||||||0.9453||||||P value within treatment. These are nominal p-values without multiplicity control.|Mixed-effects model for repeated measure|||||||0.9453
72486699|NCT03227471|144501817|OTHER||||||<|0.0001||||||P value within treatment. These are nominal p-values without multiplicity control.|Mixed-effects model for repeated measure|||||||<0.0001
72486700|NCT03227471|144501817|OTHER||||||<|0.0001||||||P value within treatment. These are nominal p-values without multiplicity control.|Mixed-effects model for repeated measure|||||||<0.0001
72486701|NCT03227471|144501817|OTHER||||||<|0.0001||||||P value within treatment. These are nominal p-values without multiplicity control.|Mixed-effects model for repeated measure|||||||<0.0001
72486702|NCT03227471|144501818|OTHER|||||||0.7849||||||P value within treatment. These are nominal p-values without multiplicity control.|mixed-effects model for repeated measure|||||||0.7849
72486703|NCT03227471|144501818|OTHER||||||<|0.0001||||||P value within treatment. These are nominal p-values without multiplicity control.|mixed-effects model for repeated measure|||||||<0.0001
72486704|NCT03227471|144501819|OTHER|||||||0.7356||||||P value within treatment. These are nominal p-values without multiplicity control.|mixed-effects model for repeated measure|||||||0.7356
72486705|NCT03227471|144501819|OTHER||||||<|0.0001||||||P value within treatment. These are nominal p-values without multiplicity control.|mixed-effects model for repeated measure|||||||<0.0001
72486706|NCT03227471|144501820|OTHER|||||||0.394||||||P value within treatment. These are nominal p-values without multiplicity control.|Mixed-effects model for repeated measure|||||||0.3940
72486707|NCT03227471|144501820|OTHER|||||||0.0003||||||P value within treatment. These are nominal p-values without multiplicity control.|Mixed-effects model for repeated measure|||||||0.0003
72486708|NCT03227471|144501820|OTHER||||||<|0.0001||||||P value within treatment. These are nominal p-values without multiplicity control.|Mixed-effects model for repeated measure|||||||<0.0001
72486709|NCT03227471|144501820|OTHER||||||<|0.0001||||||P value within treatment. These are nominal p-values without multiplicity control.|Mixed-effects model for repeated measure|||||||<0.0001
72486710|NCT03227471|144501821|OTHER|||||||0.4757||||||P value within treatment. These are nominal p-values without multiplicity control.|mixed-effects model for repeated measure|||||||0.4757
72486711|NCT03227471|144501821|OTHER||||||<|0.0001||||||P value within treatment. These are nominal p-values without multiplicity control.|mixed-effects model for repeated measure|||||||<0.0001
72486712|NCT03227471|144501822|OTHER|||||||0.007||||||P value within treatment. These are nominal p-values without multiplicity control.|mixed-effects model for repeated measure|||||||0.0070
72486713|NCT03227471|144501822|OTHER||||||<|0.0001||||||P value within treatment. These are nominal p-values without multiplicity control.|mixed-effects model for repeated measure|||||||<0.0001
72486714|NCT01488279|144501888|SUPERIORITY||Mean Difference (Net)|-10.8|STANDARD_ERROR_OF_MEAN|480.8||0.983|TWO_SIDED|95.0|-1147.6|1126.0|||ANOVA|||2X2 crossover design with baseline values. To compare the means between Sitagliptin and Placebo, a sequential three step testing process used. The results of the third step, the direct treatment comparisons are presented.||1126.0|-1147.6|.983
72486715|NCT01488279|144501891|SUPERIORITY||Mean Difference (Net)|-0.008|STANDARD_ERROR_OF_MEAN|1.935||0.997|TWO_SIDED|95.0|-4.585|4.568|||ANOVA|||||4.568|-4.585|.997
72486716|NCT01488279|144501892|SUPERIORITY||Mean Difference (Net)|-38.9|STANDARD_ERROR_OF_MEAN|49.9||0.46|TWO_SIDED|95.0|-156.9|79.0|||ANOVA|||||79.0|-156.9|.460
72486717|NCT02247960|144501968|SUPERIORITY_OR_OTHER|||||||1|||||||Chi-squared|||||||1.00
72486718|NCT01390272|144502020|NON_INFERIORITY_OR_EQUIVALENCE||Mean Difference (Net)|-2.1||||0.26|TWO_SIDED|95.0|-5.9|1.6|||Mixed Models Analysis|Constrained longitudinal model adjusting for baseline stratification variables of diabetes status and blood pressure control.||||1.6|-5.9|0.26
72486719|NCT01390272|144502021|NON_INFERIORITY_OR_EQUIVALENCE||Mean Difference (Net)|-1.3||||0.5|TWO_SIDED|95.0|-4.9|2.4|||Mixed Models Analysis|Constrained longitudinal model adjusting for baseline stratification variables of diabetes status and blood pressure control.||||2.4|-4.9|0.50
72486720|NCT01390272|144502022|NON_INFERIORITY_OR_EQUIVALENCE||Mean Difference (Net)|-1.6||||0.43|TWO_SIDED|95.0|-5.6|2.4|||Mixed Models Analysis|Constrained longitudinal model adjusting for baseline stratification variables of diabetes status and blood pressure control.||||2.4|-5.6|0.43
72513704|NCT05301322|144558219|NON_INFERIORITY|Noninferiority was declared if the lower limit of the 2-sided 95% CI for the GMR (Coadministration Group to Sequential-Administration Group) was greater than 0.667 for each of the 4 influenza strains.|GMR|0.86|||||TWO_SIDED|95.0|0.769|0.963|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences of the logarithms of the titers (Coadministration minus Sequential-Administration) and the corresponding CIs (based on Student's t distribution).|HAI: H1N1 A/Victoria||0.963|0.769|
72513705|NCT05301322|144558219|NON_INFERIORITY|Noninferiority was declared if the lower limit of the 2-sided 95% CI for the GMR (Coadministration Group to Sequential-Administration Group) was greater than 0.667 for each of the 4 influenza strains.|GMR|0.77|||||TWO_SIDED|95.0|0.68|0.866|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences of the logarithms of the titers (Coadministration minus Sequential-Administration) and the corresponding CIs (based on Student's t distribution).|HAI: H3N2 A/Darwin||0.866|0.680|
72513706|NCT05301322|144558219|NON_INFERIORITY|Noninferiority was declared if the lower limit of the 2-sided 95% CI for the GMR (Coadministration Group to Sequential-Administration Group) was greater than 0.667 for each of the 4 influenza strains.|GMR|0.9|||||TWO_SIDED|95.0|0.789|1.019|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences of the logarithms of the titers (Coadministration minus Sequential-Administration) and the corresponding CIs (based on Student's t distribution).|HAI: B/Austria||1.019|0.789|
72513707|NCT05301322|144558219|NON_INFERIORITY|Noninferiority was declared if the lower limit of the 2-sided 95% CI for the GMR (Coadministration Group to Sequential-Administration Group) was greater than 0.667 for each of the 4 influenza strains.|GMR|0.87|||||TWO_SIDED|95.0|0.779|0.964|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences of the logarithms of the titers (Coadministration minus Sequential-Administration) and the corresponding CIs (based on Student's t distribution).|HAI: B/Phuket||0.964|0.779|
72513708|NCT02198651|144558235|OTHER|||||||0.943|||||||Wald Chi|||||||0.943
72513709|NCT02198651|144558236|OTHER|||||||0.592|||||||Wald Chi|||||||0.592
72513710|NCT02198651|144558237|OTHER|||||||0.688|||||||Wald Chi|||||||0.688
72513711|NCT02924688|144558286|SUPERIORITY||Least Squares Mean Difference|0.096|STANDARD_ERROR_OF_MEAN|0.0222|<|0.001|TWO_SIDED|95.0|0.052|0.139||p-value was calculated using MMRM with covariates of treatment, age, sex, region, Baseline value, pre-study inhaled corticosteroids (ICS) dosage at screening, and visit, interaction terms for Baseline value by visit and treatment by visit.|Mixed Model Repeated Measures|||||0.139|0.052|<0.001
72513712|NCT02924688|144558286|SUPERIORITY||Least Squares Mean Difference|0.11|STANDARD_ERROR_OF_MEAN|0.0221|<|0.001|TWO_SIDED|95.0|0.066|0.153||p-value was calculated using MMRM with covariates of treatment, age, sex, region, Baseline value, pre-study ICS dosage at screening, and visit, interaction terms for Baseline value by visit and treatment by visit.|Mixed Model Repeated Measures|||||0.153|0.066|<0.001
72402800|NCT01480076|144311694|SUPERIORITY_OR_OTHER|||||||0.2214|||||||mixed effect model|||Overall, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % work time missed due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.2214
72577002|NCT00261443|144680740|SUPERIORITY_OR_OTHER_LEGACY|||||||0.675||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Change from Baseline at Week 52 (LOCF)||||0.675
72486721|NCT01390272|144502024|NON_INFERIORITY_OR_EQUIVALENCE||Odds Ratio (OR)|1.0||||0.83|TWO_SIDED|95.0|0.7|1.6|||Generalized Estimating Equation|Generalized Estimating Equation with a Logit Link. Adjusted for baseline stratification variables of diabetes status.||Comparison at 6 months||1.6|0.7|0.83
72486722|NCT01390272|144502025|NON_INFERIORITY_OR_EQUIVALENCE||Odds Ratio (OR)|0.9||||0.53|TWO_SIDED|95.0|0.5|1.4|||Generalized Estimating Equation|Generalized Estimating Equation with a Logit Link. Adjusted for baseline stratification variables of diabetes status.||Comparison at 12 months||1.4|0.5|0.53
72486723|NCT01390272|144502026|NON_INFERIORITY_OR_EQUIVALENCE||Odds Ratio (OR)|1.5||||0.09|TWO_SIDED|95.0|0.9|2.3|||Generalized Estimating Equation|Generalized Estimating Equation with a Logit Link. Adjusted for baseline stratification variables of diabetes status.||Comparison at 18 months.||2.3|0.9|0.09
72486724|NCT01390272|144502029|NON_INFERIORITY_OR_EQUIVALENCE||Odds Ratio (OR)|1.0||||0.95|TWO_SIDED|95.0|0.7|1.5|||Generalized Estimating Equation|Generalized Estimating Equation with a Logit Link. Adjusted for baseline stratification variable of diabetes status and diabetes control.||||1.5|0.7|0.95
72486725|NCT01390272|144502030|NON_INFERIORITY_OR_EQUIVALENCE||Odds Ratio (OR)|1.4||||0.12|TWO_SIDED|95.0|0.9|2.1|||Generalized Estimating Equation|Generalized Estimating Equation with a Logit Link.Adjusted for baseline stratification variable of diabetes status and blood pressure control.||Comparison at 12 months||2.1|0.9|0.12
72513713|NCT02924688|144558286|SUPERIORITY||Least Squares Mean Difference|0.082|STANDARD_ERROR_OF_MEAN|0.0221|<|0.001|TWO_SIDED|95.0|0.039|0.125||p-value was calculated using MMRM with covariates of treatment, age, sex, region, Baseline value, pre-study ICS dosage at screening, and visit, interaction terms for Baseline value by visit and treatment by visit.|Mixed Model Repeated Measures|||||0.125|0.039|<0.001
72513714|NCT02924688|144558286|SUPERIORITY||Least Squares Mean Difference|0.092|STANDARD_ERROR_OF_MEAN|0.022|<|0.001|TWO_SIDED|95.0|0.049|0.135||p-value was calculated using MMRM with covariates of treatment, age, sex, region, Baseline value, pre-study ICS dosage at screening, and visit, interaction terms for Baseline value by visit and treatment by visit.|Mixed Model Repeated Measures|||||0.135|0.049|<0.001
72513715|NCT02924688|144558287|SUPERIORITY||Rate Ratio|0.97||||0.778|TWO_SIDED|95.0|0.81|1.17||p-value was calculated using Generalized linear model with covariates for age, sex, region, treatment group, stratification by pre-study ICS dosage at screening, and severe asthma exacerbations in the previous year (0, 1, \>=2).|Negative Binomial Model||Treatment policy estimand was assessed, including all on- and post-treatment data.|||1.17|0.81|0.778
72513716|NCT02924688|144558287|SUPERIORITY||Rate Ratio|0.87||||0.151|TWO_SIDED|95.0|0.72|1.05||p-value was calculated using Generalized linear model with covariates for age, sex, region, treatment group, stratification by pre-study ICS dosage at screening, and severe asthma exacerbations in the previous year (0, 1, \>=2).|Negative Binomial Model||Treatment policy estimand was assessed, including all on- and post-treatment data.|||1.05|0.72|0.151
72513717|NCT02924688|144558288|SUPERIORITY||Least Squares Mean Difference|0.088|STANDARD_ERROR_OF_MEAN|0.0226|<|0.001|TWO_SIDED|95.0|0.044|0.132||p-value was calculated using Analysis of Covariance (ANCOVA) with covariates of treatment, age, sex, region, Baseline value, and pre-study ICS dosage at screening.|ANCOVA|||||0.132|0.044|<0.001
72513718|NCT02924688|144558288|SUPERIORITY||Least Squares Mean Difference|0.111|STANDARD_ERROR_OF_MEAN|0.0225|<|0.001|TWO_SIDED|95.0|0.067|0.155||p-value was calculated using ANCOVA with covariates of treatment, age, sex, region, Baseline value, and pre-study ICS dosage at screening.|ANCOVA|||||0.155|0.067|<0.001
72513719|NCT02924688|144558288|SUPERIORITY||Least Squares Mean Difference|0.088|STANDARD_ERROR_OF_MEAN|0.0225|<|0.001|TWO_SIDED|95.0|0.044|0.132||p-value was calculated using ANCOVA with covariates of treatment, age, sex, region, Baseline value, and pre-study ICS dosage at screening.|ANCOVA|||||0.132|0.044|<0.001
72513720|NCT02924688|144558288|SUPERIORITY||Least Squares Mean Difference|0.118|STANDARD_ERROR_OF_MEAN|0.0224|<|0.001|TWO_SIDED|95.0|0.074|0.162||p-value was calculated using ANCOVA with covariates of treatment, age, sex, region, Baseline value, and pre-study ICS dosage at screening.|ANCOVA|||||0.162|0.074|<0.001
72513721|NCT02924688|144558289|SUPERIORITY||Least Squares Mean Difference|-0.057|STANDARD_ERROR_OF_MEAN|0.034||0.094|TWO_SIDED|95.0|-0.124|0.01||p-value was calculated using MMRM with covariates of treatment, age, sex, region, Baseline value, pre-study ICS dosage at screening, and visit, interaction terms for Baseline value by visit and treatment by visit.|Mixed Model Repeated Measures|||||0.010|-0.124|0.094
72513722|NCT02924688|144558289|SUPERIORITY||Least Squares Mean Difference|-0.089|STANDARD_ERROR_OF_MEAN|0.0338||0.008|TWO_SIDED|95.0|-0.156|-0.023||p-value was calculated using MMRM with covariates of treatment, age, sex, region, Baseline value, pre-study ICS dosage at screening, and visit, interaction terms for Baseline value by visit and treatment by visit.|Mixed Model Repeated Measures|||||-0.023|-0.156|0.008
72513723|NCT02924688|144558290|OTHER||Least Squares Mean Difference|1.1|STANDARD_ERROR_OF_MEAN|0.697||0.115|TWO_SIDED|95.0|-0.27|2.47||p-value was calculated using MMRM with covariates of treatment, age, sex, region, Baseline value, pre-study ICS dosage at screening, and visit, interaction terms for Baseline value by visit and treatment by visit.|Mixed Model Repeated Measures|||||2.47|-0.27|0.115
72513724|NCT02924688|144558290|OTHER||Least Squares Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.692||0.662|TWO_SIDED|95.0|-1.66|1.05||p-value was calculated using MMRM with covariates of treatment, age, sex, region, Baseline value, pre-study ICS dosage at screening, and visit, interaction terms for Baseline value by visit and treatment by visit.|Mixed Model Repeated Measures|||||1.05|-1.66|0.662
72567905|NCT02037165|144667467|SUPERIORITY_OR_OTHER||adjusted mean difference|1.72|STANDARD_ERROR_OF_MEAN|2.0789|||TWO_SIDED|95.0|-2.4|5.8|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 4:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||5.8|-2.4|
72567906|NCT02037165|144667467|SUPERIORITY_OR_OTHER||adjusted mean difference|-0.15|STANDARD_ERROR_OF_MEAN|2.079|||TWO_SIDED|95.0|-4.2|3.9|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 5:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||3.9|-4.2|
72567907|NCT02037165|144667467|SUPERIORITY_OR_OTHER||adjusted mean difference|-3.15|STANDARD_ERROR_OF_MEAN|2.0792|||TWO_SIDED|95.0|-7.2|0.9|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 6:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||0.9|-7.2|
72567908|NCT02037165|144667467|SUPERIORITY_OR_OTHER||adjusted mean difference|-1.31|STANDARD_ERROR_OF_MEAN|2.0796|||TWO_SIDED|95.0|-5.4|2.8|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 22:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||2.8|-5.4|
72402801|NCT01480076|144311694|SUPERIORITY_OR_OTHER||difference of LS means|8.9|STANDARD_ERROR_OF_MEAN|4.96||0.0743|TWO_SIDED||||||mixed effect model|||Overall, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % work time missed due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0743
72513725|NCT02924688|144558291|OTHER||Least Squares Mean Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.185||0.479|TWO_SIDED|95.0|-0.49|0.23||p-value was calculated using MMRM with covariates of treatment, age, sex, region, Baseline value, pre-study ICS dosage at screening, and 4-weekly period, interaction terms for Baseline value by 4-weekly period and treatment by 4-weekly period.|Mixed Model Repeated Measures|||||0.23|-0.49|0.479
72513726|NCT02924688|144558291|OTHER||Least Squares Mean Difference|-0.42|STANDARD_ERROR_OF_MEAN|0.184||0.023|TWO_SIDED|95.0|-0.78|-0.06||p-value was calculated using MMRM with covariates of treatment, age, sex, region, Baseline value, pre-study ICS dosage at screening, and 4-weekly period, interaction terms for Baseline value by 4-weekly period and treatment by 4-weekly period.|Mixed Model Repeated Measures|||||-0.06|-0.78|0.023
72577003|NCT00261443|144680740|SUPERIORITY_OR_OTHER_LEGACY|||||||0.592||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Highest Value of Change in Total Bilirubin, Phase 3 Safety Sample||||0.592
72577004|NCT00261443|144680741|SUPERIORITY_OR_OTHER_LEGACY|||||||0.273||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Baseline Triglycerides (fasting)||||0.273
72577005|NCT00261443|144680741|SUPERIORITY_OR_OTHER_LEGACY|||||||0.489||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Change from Baseline at Week 52 (LOCF)||||0.489
72486726|NCT01390272|144502031|NON_INFERIORITY_OR_EQUIVALENCE||Odds Ratio (OR)|1.2||||0.3|TWO_SIDED|95.0|0.8|1.9|||Generalized Estimating Equation|Generalized Estimating Equation with a Logit Link. Adjusted for baseline stratification variables of diabetes status and blood pressure control.||Comparison at 18 months||1.9|0.8|0.30
72486727|NCT00073528|144502063|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.71||||0.019|TWO_SIDED|95.0|0.53|0.96||p-value is from stratified log-rank test, stratifying for site of disease and time since prior adjuvant endocrine therapy at screening|Log Rank||The estimate of the treatment Hazard Ratio wase based on the log-rank test.|||0.96|0.53|0.019
72486728|NCT00073528|144502064|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.71||||0.019|TWO_SIDED|95.0|0.53|0.96||p-value is from stratified log-rank test, stratifying for site of disease and time since prior adjuvant endocrine therapy at screening|Log Rank||The estimate of the treatment Hazard Ratio was based on the log-rank test.|||0.96|0.53|0.019
72486729|NCT02887404|144502100|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.92|TWO_SIDED|95.0|-6.0|6.0|||t-test, 2 sided|||||6|-6|0.92
72486730|NCT02887404|144502101|NON_INFERIORITY|Delta: 15. The significance level for non-inferiority was 0.025|Median Difference (Final Values)|-9.0|||<|0.001|TWO_SIDED|95.0|-21.0|3.0|||Hodges-Lehmann estimator|||||3|-21|<0.001
72486731|NCT02887404|144502101|SUPERIORITY||Median Difference (Final Values)|-9.0||||0.175|TWO_SIDED|97.5|-23.0|5.0||We adjusted for two outcomes for the superiority testing only, using a significance criterion of 0.0125 for each outcome (i.e., 0.025/2, Bonferroni correction), since superiority on either outcome would suffice.|Hodges-Lehmann estimator|||||5|-23|0.175
72486732|NCT02887404|144502102|NON_INFERIORITY|Delta: 1 The significance level for the non-inferiority test was 0.025.|Mean Difference (Final Values)|-0.4|||<|0.001|TWO_SIDED|95.0|-0.8|1.0||This is a joint hypothesis testing. We tested non-inferiority on both secondary outcomes. If both showed significant non-inferiority, we tested superiority on both outcomes.|Regression, Linear|||||1|-0.8|<0.001
72486733|NCT02887404|144502102|SUPERIORITY||Mean Difference (Final Values)|-0.4||||0.094|TWO_SIDED|97.5|-0.8|0.1||We adjusted for two outcomes for the superiority testing only, using a significance criterion of 0.0125 for each outcome (i.e., 0.025/2, Bonferroni correction), since superiority on either outcome would suffice|Regression, Linear|||||0.1|-0.8|0.094
72486734|NCT02887404|144502120|NON_INFERIORITY|Delta: 9; significance level was 0.025|Median Difference (Final Values)|-0.1|||<|0.001|TWO_SIDED|95.0|-0.3|0.1|||Wilcoxon (Mann-Whitney)|||||0.1|-0.3|<0.001
72486735|NCT02887404|144502120|SUPERIORITY||Median Difference (Final Values)|-0.1||||0.171|TWO_SIDED|97.5|-0.3|0.1||We adjusted for two outcomes for the superiority testing only, using a significance criterion of 0.0125 for each outcome (i.e., 0.025/2, Bonferroni correction), since superiority on either outcome would suffice|Wilcoxon sum rank test|||||0.1|-0.3|0.171
72486736|NCT02887404|144502121|NON_INFERIORITY|Delta: 1 significance level: 0.025|Mean Difference (Final Values)|-0.5|||<|0.001|TWO_SIDED|95.0|-1.0|-0.1|||Regression, Linear||||The superiority test (this is a joint-hypothesis testing) showed a mean difference of -0.5 between treatment and control group with 97.5% CI of (-1.0, 0.0) and p-value of 0.025. The significance level was 0.025.|-0.1|-1.0|<0.001
72486737|NCT02887404|144502121|SUPERIORITY||Mean Difference (Final Values)|-0.5||||0.025|TWO_SIDED|97.5|-1.0|0.0||We adjusted for two outcomes for the superiority testing only, using a significance criterion of 0.0125 for each outcome (i.e., 0.025/2, Bonferroni correction), since superiority on either outcome would suffice|Regression, Linear|||||0.0|-1.0|0.025
72486738|NCT04305275|144502122|SUPERIORITY||Least Squares (LS) Mean Difference|-1.07|STANDARD_ERROR_OF_MEAN|0.533||0.0491|TWO_SIDED|95.0|-2.14|0.0|||MMRM|MMRM model included treatment, baseline score, assessment timepoint, \& timepoint-by-treatment as explanatory variables, treated as fixed effects.||||0.00|-2.14|0.0491
72486739|NCT04305275|144502123|SUPERIORITY||LS mean difference|-0.81|STANDARD_ERROR_OF_MEAN|0.398||0.0468|TWO_SIDED|95.0|-1.6|-0.01|||MMRM|MMRM model included treatment, baseline score, assessment timepoint, \& timepoint-by-treatment as explanatory variables, treated as fixed effects.||Change From Baseline at Day 8||-0.01|-1.60|0.0468
72486740|NCT04305275|144502123|SUPERIORITY||LS mean difference|-0.48|STANDARD_ERROR_OF_MEAN|0.467||0.3124|TWO_SIDED|95.0|-1.41|0.46|||MMRM|MMRM model included treatment, baseline score, assessment timepoint, \& timepoint-by-treatment as explanatory variables, treated as fixed effects.||Change From Baseline at Day 15, Pre-dose||0.46|-1.41|0.3124
72486741|NCT04305275|144502123|SUPERIORITY||LS mean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.605||0.5148|TWO_SIDED|95.0|-1.61|0.81|||MMRM|MMRM model included treatment, baseline score, assessment timepoint, \& timepoint-by-treatment as explanatory variables, treated as fixed effects.||Change From Baseline at Day 15, 5 Hours Post-dose||0.81|-1.61|0.5148
72486742|NCT04305275|144502123|SUPERIORITY||LS mean difference|-0.27|STANDARD_ERROR_OF_MEAN|0.59||0.6452|TWO_SIDED|95.0|-1.45|0.91|||MMRM|MMRM model included treatment, baseline score, assessment timepoint, \& timepoint-by-treatment as explanatory variables, treated as fixed effects.||Change From Baseline at Day 15, 8 Hours Post-dose||0.91|-1.45|0.6452
72486743|NCT04305275|144502123|SUPERIORITY||LS mean difference|-0.77|STANDARD_ERROR_OF_MEAN|0.482||0.1171|TWO_SIDED|95.0|-1.73|0.2|||MMRM|MMRM model included treatment, baseline score, assessment timepoint, \& timepoint-by-treatment as explanatory variables, treated as fixed effects.||Change From Baseline at Day 22||0.20|-1.73|0.1171
72486744|NCT04305275|144502123|SUPERIORITY||LS mean difference|0.62|STANDARD_ERROR_OF_MEAN|0.557||0.2724|TWO_SIDED|95.0|-0.5|1.73|||MMRM|MMRM model included treatment, baseline score, assessment timepoint, \& timepoint-by-treatment as explanatory variables, treated as fixed effects.||Change From Baseline at Day 42||1.73|-0.50|0.2724
72486745|NCT04305275|144502124|SUPERIORITY||LS mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.658||0.8784|TWO_SIDED|95.0|-1.42|1.21|||MMRM|MMRM model included treatment, baseline score, assessment timepoint, \& timepoint-by-treatment as explanatory variables, treated as fixed effects.||Change From Baseline at Day 8||1.21|-1.42|0.8784
72486746|NCT04305275|144502124|SUPERIORITY||LS mean difference|0.93|STANDARD_ERROR_OF_MEAN|0.687||0.1795|TWO_SIDED|95.0|-0.44|2.3|||MMRM|MMRM model included treatment, baseline score, assessment timepoint, \& timepoint-by-treatment as explanatory variables, treated as fixed effects.||Change From Baseline at Day 15, Pre-dose||2.30|-0.44|0.1795
72486747|NCT04305275|144502124|SUPERIORITY||LS mean difference|-0.49|STANDARD_ERROR_OF_MEAN|0.829||0.5588|TWO_SIDED|95.0|-2.15|1.17|||MMRM|MMRM model included treatment, baseline score, assessment timepoint, \& timepoint-by-treatment as explanatory variables, treated as fixed effects.||Change From Baseline at Day 15, 5 Hours Post-dose||1.17|-2.15|0.5588
72486748|NCT04305275|144502124|SUPERIORITY||LS mean difference|0.54|STANDARD_ERROR_OF_MEAN|0.796||0.5036|TWO_SIDED|95.0|-1.06|2.13|||MMRM|MMRM model included treatment, baseline score, assessment timepoint, \& timepoint-by-treatment as explanatory variables, treated as fixed effects.||Change From Baseline at Day 15, 8 Hours Post-dose||2.13|-1.06|0.5036
72486749|NCT04305275|144502124|SUPERIORITY||LS mean difference|0.32|STANDARD_ERROR_OF_MEAN|0.736||0.6636|TWO_SIDED|95.0|-1.15|1.79|||MMRM|MMRM model included treatment, baseline score, assessment timepoint, \& timepoint-by-treatment as explanatory variables, treated as fixed effects.||Change From Baseline at Day 22||1.79|-1.15|0.6636
72486750|NCT04305275|144502124|SUPERIORITY||LS mean difference|0.64|STANDARD_ERROR_OF_MEAN|0.756||0.3999|TWO_SIDED|95.0|-0.87|2.15|||MMRM|MMRM model included treatment, baseline score, assessment timepoint, \& timepoint-by-treatment as explanatory variables, treated as fixed effects.||Change From Baseline at Day 29||2.15|-0.87|0.3999
72486751|NCT04305275|144502124|SUPERIORITY||LS mean difference|0.67|STANDARD_ERROR_OF_MEAN|0.776||0.3933|TWO_SIDED|95.0|-0.88|2.22|||MMRM|MMRM model included treatment, baseline score, assessment timepoint, \& timepoint-by-treatment as explanatory variables, treated as fixed effects.||Change From Baseline at Day 42||2.22|-0.88|0.3933
72486752|NCT04305275|144502125|SUPERIORITY||LS mean difference|-2.8|STANDARD_ERROR_OF_MEAN|1.167||0.0193|TWO_SIDED|95.0|-5.14|-0.47|||MMRM|MMRM model included treatment, baseline score, assessment timepoint, \& timepoint-by-treatment as explanatory variables, treated as fixed effects.||Change From Baseline at Day 8||-0.47|-5.14|0.0193
72486753|NCT04305275|144502125|SUPERIORITY||LS mean difference|-2.95|STANDARD_ERROR_OF_MEAN|1.277||0.0243|TWO_SIDED|95.0|-5.51|-0.4|||MMRM|MMRM model included treatment, baseline score, assessment timepoint, \& timepoint-by-treatment as explanatory variables, treated as fixed effects.||Change From Baseline at Day 15||-0.40|-5.51|0.0243
72486754|NCT04305275|144502125|SUPERIORITY||LS mean difference|-2.56|STANDARD_ERROR_OF_MEAN|1.209||0.0385|TWO_SIDED|95.0|-4.98|-0.14|||MMRM|MMRM model included treatment, baseline score, assessment timepoint, \& timepoint-by-treatment as explanatory variables, treated as fixed effects.||Change From Baseline at Day 22||-0.14|-4.98|0.0385
72486755|NCT04305275|144502125|SUPERIORITY||LS mean difference|-1.37|STANDARD_ERROR_OF_MEAN|1.221||0.2682|TWO_SIDED|95.0|-3.81|1.08|||MMRM|MMRM model included treatment, baseline score, assessment timepoint, \& timepoint-by-treatment as explanatory variables, treated as fixed effects.||Change From Baseline at Day 29||1.08|-3.81|0.2682
72486756|NCT04305275|144502125|SUPERIORITY||LS mean difference|1.13|STANDARD_ERROR_OF_MEAN|1.233||0.3649|TWO_SIDED|95.0|-1.34|3.59|||MMRM|MMRM model included treatment, baseline score, assessment timepoint, \& timepoint-by-treatment as explanatory variables, treated as fixed effects.||Change From Baseline at Day 42||3.59|-1.34|0.3649
72486757|NCT04305275|144502126|SUPERIORITY||LS mean difference|-1.26|STANDARD_ERROR_OF_MEAN|1.078||0.2478|TWO_SIDED|95.0|-3.41|0.9|||MMRM|MMRM model included treatment, baseline score, assessment timepoint, \& timepoint-by-treatment as explanatory variables, treated as fixed effects.||Change From Baseline at Day 8||0.90|-3.41|0.2478
72486758|NCT04305275|144502126|SUPERIORITY||LS mean difference|-0.91|STANDARD_ERROR_OF_MEAN|1.192||0.4486|TWO_SIDED|95.0|-3.29|1.47|||MMRM|MMRM model included treatment, baseline score, assessment timepoint, \& timepoint-by-treatment as explanatory variables, treated as fixed effects.||Change From Baseline at Day 15, Pre-dose||1.47|-3.29|0.4486
72513727|NCT02924688|144558294|OTHER||Least Squares Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.75||0.172|TWO_SIDED|95.0|-2.5|0.4||p-value was calculated using MMRM with covariates of treatment, age, sex, region, Baseline value, pre-study ICS dosage at screening, and visit, interaction terms for Baseline value by visit and treatment by visit.|Mixed Model Repeated Measures||Comparison for SBP|||0.4|-2.5|0.172
72513728|NCT02924688|144558294|OTHER||Least Squares Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.74||0.436|TWO_SIDED|95.0|-2.0|0.9||p-value was calculated using MMRM with covariates of treatment, age, sex, region, Baseline value, pre-study ICS dosage at screening, and visit, interaction terms for Baseline value by visit and treatment by visit.|Mixed Model Repeated Measures||Comparison for SBP|||0.9|-2.0|0.436
72513729|NCT02924688|144558294|OTHER||Least Squares Mean Difference|0.6|STANDARD_ERROR_OF_MEAN|0.75||0.426|TWO_SIDED|95.0|-0.9|2.1||p-value was calculated using MMRM with covariates of treatment, age, sex, region, Baseline value, pre-study ICS dosage at screening, and visit, interaction terms for Baseline value by visit and treatment by visit.|Mixed Model Repeated Measures||Comparison for SBP|||2.1|-0.9|0.426
72513730|NCT02924688|144558294|OTHER||Least Squares Mean Difference|0.7|STANDARD_ERROR_OF_MEAN|0.74||0.349|TWO_SIDED|95.0|-0.8|2.2||p-value was calculated using MMRM with covariates of treatment, age, sex, region, Baseline value, pre-study ICS dosage at screening, and visit, interaction terms for Baseline value by visit and treatment by visit.|Mixed Model Repeated Measures||Comparison for SBP|||2.2|-0.8|0.349
72577006|NCT00261443|144680741|SUPERIORITY_OR_OTHER_LEGACY|||||||0.415||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Highest Value of Change in Triglycerides (fasting), Phase 3 Safety Sample||||0.415
72486759|NCT04305275|144502126|SUPERIORITY||LS mean difference|-1.52|STANDARD_ERROR_OF_MEAN|1.352||0.2662|TWO_SIDED|95.0|-4.22|1.19|||MMRM|MMRM model included treatment, baseline score, assessment timepoint, \& timepoint-by-treatment as explanatory variables, treated as fixed effects.||Change From Baseline at Day 15, 5 Hours Post-dose||1.19|-4.22|0.2662
72486760|NCT04305275|144502126|SUPERIORITY||LS mean difference|0.01|STANDARD_ERROR_OF_MEAN|1.282||0.9965|TWO_SIDED|95.0|-2.56|2.57|||MMRM|MMRM model included treatment, baseline score, assessment timepoint, \& timepoint-by-treatment as explanatory variables, treated as fixed effects.||Change From Baseline at Day 15, 8 Hours Post-dose||2.57|-2.56|0.9965
72486761|NCT04305275|144502126|SUPERIORITY||LS mean difference|-0.24|STANDARD_ERROR_OF_MEAN|1.222||0.8437|TWO_SIDED|95.0|-2.68|2.2|||MMRM|MMRM model included treatment, baseline score, assessment timepoint, \& timepoint-by-treatment as explanatory variables, treated as fixed effects.||Change From Baseline at Day 22||2.20|-2.68|0.8437
72486762|NCT04305275|144502126|SUPERIORITY||LS mean difference|-0.32|STANDARD_ERROR_OF_MEAN|1.232||0.796|TWO_SIDED|95.0|-2.78|2.14|||MMRM|MMRM model included treatment, baseline score, assessment timepoint, \& timepoint-by-treatment as explanatory variables, treated as fixed effects.||Change From Baseline at Day 29||2.14|-2.78|0.7960
72402802|NCT01480076|144311694|SUPERIORITY_OR_OTHER||difference of LS means|-17.2|STANDARD_ERROR_OF_MEAN|12.22||0.1601|TWO_SIDED||||||mixed effect model|||Overall, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % work time missed due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.1601
72402803|NCT01480076|144311694|SUPERIORITY_OR_OTHER|||||||0.1251|||||||mixed effect model|||Month 3, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % work time missed due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.1251
72402804|NCT01480076|144311694|SUPERIORITY_OR_OTHER|||||||0.1764|||||||mixed effect model|||Month 3, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % work time missed due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.1764
72402805|NCT01480076|144311694|SUPERIORITY_OR_OTHER|||||||0.5528|||||||mixed effect model|||Month 3, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % work time missed due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.5528
72402806|NCT01480076|144311694|SUPERIORITY_OR_OTHER|||||||0.108|||||||mixed effect model|||Month 3, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % work time missed due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.1080
72402807|NCT01480076|144311694|SUPERIORITY_OR_OTHER||difference of LS means|4.6|STANDARD_ERROR_OF_MEAN|6.27||0.4644|TWO_SIDED||||||mixed effect model|||Month 3, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % work time missed due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.4644
72402808|NCT01480076|144311694|SUPERIORITY_OR_OTHER||difference of LS means|-30.6|STANDARD_ERROR_OF_MEAN|17.91||0.0887|TWO_SIDED||||||mixed effect model|||Month 3, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % work time missed due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0887
72402809|NCT01480076|144311694|SUPERIORITY_OR_OTHER|||||||0.0071|||||||mixed effect model|||Month 6, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % work time missed due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0071
72402810|NCT01480076|144311694|SUPERIORITY_OR_OTHER|||||||0.064|||||||mixed effect model|||Month 6, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % work time missed due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0640
72402811|NCT01480076|144311694|SUPERIORITY_OR_OTHER|||||||0.1552|||||||mixed effect model|||Month 6, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % work time missed due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.1552
72402812|NCT01480076|144311694|SUPERIORITY_OR_OTHER|||||||0.5979|||||||mixed effect model|||Month 6, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % work time missed due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.5979
72402813|NCT01480076|144311694|SUPERIORITY_OR_OTHER||difference of LS means|4.3|STANDARD_ERROR_OF_MEAN|5.58||0.4444|TWO_SIDED||||||mixed effect model|||Month 6, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % work time missed due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.4444
72577007|NCT00261443|144680742|SUPERIORITY_OR_OTHER_LEGACY|||||||0.189||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Baseline Uric Acid||||0.189
72402814|NCT01480076|144311694|SUPERIORITY_OR_OTHER||difference of LS means|-10.7|STANDARD_ERROR_OF_MEAN|12.27||0.3863|TWO_SIDED||||||mixed effect model|||Month 6, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % work time missed due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.3863
72577008|NCT00261443|144680742|SUPERIORITY_OR_OTHER_LEGACY|||||||0.35||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Change from Baseline at Week 52 (LOCF)||||0.350
72486763|NCT04305275|144502126|SUPERIORITY||LS mean difference|2.28|STANDARD_ERROR_OF_MEAN|1.119||0.0456|TWO_SIDED|95.0|0.05|4.52|||MMRM|MMRM model included treatment, baseline score, assessment timepoint, \& timepoint-by-treatment as explanatory variables, treated as fixed effects.||Change From Baseline at Day 42||4.52|0.05|0.0456
72486764|NCT01022242|144502138|SUPERIORITY_OR_OTHER|||||||0.8861|||||||ANCOVA|||||||0.8861
72486765|NCT01536951|144502145|SUPERIORITY_OR_OTHER||Least squares (LS) mean difference|0.239|||||TWO_SIDED|90.0|-1.65|2.12|||||LS mean difference (LY3009104 minus placebo) of change in QTcP 1 h postdose analyzed using analysis of covariance (ANCOVA) model adjusted for baseline QTc, treatment, time, period, sequence, treatment-by-time, participant, and participant-by-period.|||2.12|-1.65|
72486766|NCT01536951|144502145|SUPERIORITY_OR_OTHER||LS mean difference|1.81|||||TWO_SIDED|90.0|-0.079|3.69|||||LS mean difference (LY3009104 minus placebo) of change in QTcP at 1.5 h postdose was analyzed using an ANCOVA model adjusted for baseline QTc, treatment, time, period, sequence, treatment-by-time, participant, and participant-by-period.|||3.69|-0.0790|
72486767|NCT01536951|144502145|SUPERIORITY_OR_OTHER||LS Mean Difference|1.44|||||TWO_SIDED|90.0|-0.446|3.32|||||LS mean difference (LY3009104 minus placebo) of change in QTcP at 2 h postdose was analyzed using an ANCOVA model adjusted for baseline QTc, treatment, time, period, sequence, treatment-by-time, participant, and participant-by-period.|||3.32|-0.446|
72486768|NCT01536951|144502145|SUPERIORITY_OR_OTHER||LS mean difference|0.468|||||TWO_SIDED|90.0|-1.42|2.35|||||LS mean difference (LY3009104 minus placebo) of change in QTcP at 3 h postdose was analyzed using an ANCOVA model adjusted for baseline QTc, treatment, time, period, sequence, treatment-by-time, participant, and participant-by-period.|||2.35|-1.42|
72486769|NCT01536951|144502145|SUPERIORITY_OR_OTHER||LS mean difference|0.702|||||TWO_SIDED|90.0|-1.18|2.59|||||LS mean difference (LY3009104 minus placebo) of change in QTcP at 4 h postdose was analyzed using an ANCOVA model adjusted for baseline QTc, treatment, time, period, sequence, treatment-by-time, participant, and participant-by-period.|||2.59|-1.18|
72486770|NCT01536951|144502145|SUPERIORITY_OR_OTHER||LS mean difference|-0.788|||||TWO_SIDED|90.0|-2.68|1.1|||||LS mean difference (LY3009104 minus placebo) of change in QTcP at 6 h postdose was analyzed using an ANCOVA model adjusted for baseline QTc, treatment, time, period, sequence, treatment-by-time, participant, and participant-by-period.|||1.10|-2.68|
72513731|NCT02924688|144558294|OTHER||Least Squares Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.56||0.482|TWO_SIDED|95.0|-1.5|0.7||p-value was calculated using MMRM with covariates of treatment, age, sex, region, Baseline value, pre-study ICS dosage at screening, and visit, interaction terms for Baseline value by visit and treatment by visit.|Mixed Model Repeated Measures||Comparison for DBP|||0.7|-1.5|0.482
72513732|NCT02924688|144558294|OTHER||Least Squares Mean Difference|0.8|STANDARD_ERROR_OF_MEAN|0.56||0.142|TWO_SIDED|95.0|-0.3|1.9||p-value was calculated using MMRM with covariates of treatment, age, sex, region, Baseline value, pre-study ICS dosage at screening, and visit, interaction terms for Baseline value by visit and treatment by visit.|Mixed Model Repeated Measures||Comparison for DBP|||1.9|-0.3|0.142
72486771|NCT01536951|144502145|SUPERIORITY_OR_OTHER||LS mean difference|1.71|||||TWO_SIDED|90.0|-0.182|3.6|||||LS mean difference (LY3009104 minus placebo) of change in QTcP at 12 h postdose was analyzed using an ANCOVA model adjusted for baseline QTc, treatment, time, period, sequence, treatment-by-time, participant, and participant-by-period.|||3.60|-0.182|
72486772|NCT01536951|144502145|SUPERIORITY_OR_OTHER||LS mean difference|0.963|||||TWO_SIDED|90.0|-0.921|2.85|||||LS mean difference (LY3009104 minus placebo) of change in QTcP at 24 h postdose was analyzed using an ANCOVA model adjusted for baseline QTc, treatment, time, period, sequence, treatment-by-time, participant, and participant-by-period.|||2.85|-0.921|
72513733|NCT02924688|144558294|OTHER||Least Squares Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.56||0.806|TWO_SIDED|95.0|-1.2|1.0||p-value was calculated using MMRM with covariates of treatment, age, sex, region, Baseline value, pre-study ICS dosage at screening, and visit, interaction terms for Baseline value by visit and treatment by visit.|Mixed Model Repeated Measures||Comparison for DBP|||1.0|-1.2|0.806
72486773|NCT01536951|144502145|SUPERIORITY_OR_OTHER||LS mean difference|12.3|||||TWO_SIDED|90.0|10.0|14.5|||||LS mean difference (moxifloxacin minus placebo) of change in QTcP at 1 h postdose was analyzed using an ANCOVA model adjusted for baseline QTc, treatment, time, period, sequence, treatment-by-time, participant, and participant-by-period.|||14.5|10.0|
72486774|NCT01536951|144502145|SUPERIORITY_OR_OTHER||LS mean difference|11.0|||||TWO_SIDED|90.0|8.74|13.3|||||LS mean difference (moxifloxacin minus placebo) of change in QTcP at 2 h postdose was analyzed using an ANCOVA model adjusted for baseline QTc, treatment, time, period, sequence, treatment-by-time, participant, and participant-by-period.|||13.3|8.74|
72486775|NCT01536951|144502145|SUPERIORITY_OR_OTHER||LS mean difference|11.1|||||TWO_SIDED|90.0|8.87|13.4|||||LS mean difference (moxifloxacin minus placebo) of change in QTcP at 4 h postdose was analyzed using an ANCOVA model adjusted for baseline QTc, treatment, time, period, sequence, treatment-by-time, participant, and participant-by-period.|||13.4|8.87|
72486776|NCT01843972|144502149|SUPERIORITY_OR_OTHER||Geometric mean ratio (net)|97.88|STANDARD_DEVIATION|24.8|||TWO_SIDED|90.0|79.963|119.809|||ANOVA||The geometric mean ratio is calculated as the geometric mean of 'BI 691751 tablet extensive metabolizers (part II)' divided by the geometric mean of 'BI 691751 solution (part II)'.|Only extensive CYP2D6 metabolisers were selected: 12 (all) subjects of group 'BI 691751 tablet extensive metabolizers (part II)' and 7 (all investigated) subjects of group 'BI 691751 solution (part II) '.||119.809|79.963|
72486777|NCT01843972|144502149|SUPERIORITY_OR_OTHER||Geometric mean ratio (net)|111.2|STANDARD_DEVIATION|24.7|||TWO_SIDED|90.0|88.596|139.576|||ANOVA||The geometric mean ratio was calculated as the geometric mean of the poor metabolisers divided by the geometric mean of the extensive metabolisers.|Comparison of poor metabolisers (5 (all) subjects of group 'BI 691751 tablet poor metabolizers (part II)') and extensive metabolisers (12 (all) subjects of group 'BI 691751 tablet extensive metabolizers (part II)').||139.576|88.596|
72577009|NCT00261443|144680742|SUPERIORITY_OR_OTHER_LEGACY|||||||0.799||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Highest Value of Change in Uric Acid, Phase 3 Safety Sample||||0.799
72577010|NCT00261443|144680743|SUPERIORITY_OR_OTHER_LEGACY|||||||0.124||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Baseline Leukocytes||||0.124
72577011|NCT00261443|144680743|SUPERIORITY_OR_OTHER_LEGACY|||||||0.295||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Change from Baseline at Week 52 (LOCF)||||0.295
72513734|NCT02924688|144558294|OTHER||Least Squares Mean Difference|0.4|STANDARD_ERROR_OF_MEAN|0.55||0.447|TWO_SIDED|95.0|-0.7|1.5||p-value was calculated using MMRM with covariates of treatment, age, sex, region, Baseline value, pre-study ICS dosage at screening, and visit, interaction terms for Baseline value by visit and treatment by visit.|Mixed Model Repeated Measures||Comparison for DBP|||1.5|-0.7|0.447
72513735|NCT02924688|144558295|OTHER||Least Squares Mean Difference|1.3|STANDARD_ERROR_OF_MEAN|0.61||0.034|TWO_SIDED|95.0|0.1|2.5||p-value was calculated using MMRM with covariates of treatment, age, sex, region, Baseline value, pre-study ICS dosage at screening, and visit, interaction terms for Baseline value by visit and treatment by visit.|Mixed Model Repeated Measures|||||2.5|0.1|0.034
72513736|NCT02924688|144558295|OTHER||Least Squares Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.61||0.839|TWO_SIDED|95.0|-1.1|1.3||p-value was calculated using MMRM with covariates of treatment, age, sex, region, Baseline value, pre-study ICS dosage at screening, and visit, interaction terms for Baseline value by visit and treatment by visit.|Mixed Model Repeated Measures|||||1.3|-1.1|0.839
72513737|NCT02924688|144558295|OTHER||Least Squares Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.61||0.349|TWO_SIDED|95.0|-1.8|0.6||p-value was calculated using MMRM with covariates of treatment, age, sex, region, Baseline value, pre-study ICS dosage at screening, and visit, interaction terms for Baseline value by visit and treatment by visit.|Mixed Model Repeated Measures|||||0.6|-1.8|0.349
72567909|NCT02037165|144667467|SUPERIORITY_OR_OTHER||adjusted mean difference|-0.15|STANDARD_ERROR_OF_MEAN|2.0801|||TWO_SIDED|95.0|-4.2|3.9|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 24:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||3.9|-4.2|
72402815|NCT01480076|144311694|SUPERIORITY_OR_OTHER|||||||0.6352|||||||mixed effect model|||Month 9, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % work time missed due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.6352
72513738|NCT02924688|144558295|OTHER||Least Squares Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|0.61||0.768|TWO_SIDED|95.0|-1.0|1.4||p-value was calculated using MMRM with covariates of treatment, age, sex, region, Baseline value, pre-study ICS dosage at screening, and visit, interaction terms for Baseline value by visit and treatment by visit.|Mixed Model Repeated Measures|||||1.4|-1.0|0.768
72513739|NCT00848250|144558342|SUPERIORITY|||||||0.03|||||||ANOVA|||||||0.03
72513740|NCT00848250|144558343|SUPERIORITY|||||||0.13|||||||ANOVA|Repeated measures||||||0.13
72513741|NCT00848250|144558344|SUPERIORITY|||||||0.02|||||||ANOVA|Repeated measures||||||0.02
72513742|NCT00848250|144558345|SUPERIORITY|||||||0.67|||||||ANOVA|Repeated measures||||||0.67
72513743|NCT00848250|144558347|SUPERIORITY|||||||0.47|||||||t-test, 2 sided|||P-value is for comparison of chest tube output at 24 hours||||0.47
72513744|NCT00848250|144558348|SUPERIORITY|||||||0.41|||||||Fisher Exact|||||||0.41
72513745|NCT02724774|144558351|SUPERIORITY|||||||0.026||||||a priori threshold for statistical significance p \< .05|Regression, Linear|||All analyses were conducted as intention-to-treat, analyzing all 252 cases as randomly assigned to the PFR and control group (CG). Multiple linear regression was used to examine the treatment effect of PFR (0 = CG, 1 = PFR). Covariates included preferred language (0 = English, 1 = Spanish) and the baseline measure.||||.026
72567910|NCT02037165|144667467|SUPERIORITY_OR_OTHER||Adjusted mean difference|-2.68|STANDARD_ERROR_OF_MEAN|2.0282|||TWO_SIDED|95.0|-6.7|1.3|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 0:30h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||1.3|-6.7|
72567911|NCT02037165|144667467|SUPERIORITY_OR_OTHER||adjusted mean difference|1.58|STANDARD_ERROR_OF_MEAN|2.0279|||TWO_SIDED|95.0|-2.4|5.6|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 1:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||5.6|-2.4|
72567912|NCT02037165|144667467|SUPERIORITY_OR_OTHER||adjusted mean difference|2.63|STANDARD_ERROR_OF_MEAN|2.0278|||TWO_SIDED|95.0|-1.4|6.6|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 2:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||6.6|-1.4|
72486778|NCT01843972|144502150|SUPERIORITY_OR_OTHER||Geometric mean ratio (net)|101.31|STANDARD_DEVIATION|28.2|||TWO_SIDED|90.0|80.593|127.351|||ANOVA||The geometric mean ratio is calculated as the geometric mean of 'BI 691751 tablet extensive metabolizers (part II)' divided by the geometric mean of 'BI 691751 solution (part II)'.|Only extensive CYP2D6 metabolisers were selected: 12 (all) subjects of group 'BI 691751 tablet extensive metabolizers (part II)' and 7 (all investigated) subjects of group 'BI 691751 solution (part II) '.||127.351|80.593|
72486779|NCT01843972|144502150|SUPERIORITY_OR_OTHER||Geometric mean ratio (net)|92.69|STANDARD_DEVIATION|33.0|||TWO_SIDED|90.0|68.662|125.119|||ANOVA||The geometric mean ratio was calculated as the geometric mean of the poor metabolisers divided by the geometric mean of the extensive metabolisers.|Comparison of poor metabolisers (5 (all) subjects of group 'BI 691751 tablet poor metabolizers (part II)') and extensive metabolisers (12 (all) subjects of group 'BI 691751 tablet extensive metabolizers (part II)').||125.119|68.662|
72486780|NCT01843972|144502151|NON_INFERIORITY_OR_EQUIVALENCE|This was non-confirmatory testing.|Slope|1.0233|||||TWO_SIDED|95.0|0.8265|1.2201|||Regression, Linear|||||1.2201|0.8265|
72486781|NCT01843972|144502152|NON_INFERIORITY_OR_EQUIVALENCE|This was non-confirmatory testing.|Slope|0.9686|||||TWO_SIDED|95.0|0.8107|1.1266|||Regression, Linear|||Dose proportionality of BI 691751 was explored using a power model (regression model applied to log-transformed data).||1.1266|0.8107|
72486782|NCT01843972|144502153|SUPERIORITY_OR_OTHER||Geometric mean ratio (net)|95.48|STANDARD_DEVIATION|30.8|||TWO_SIDED|90.0|74.414|122.511|||ANOVA||The geometric mean ratio is calculated as the geometric mean of 'BI 691751 tablet extensive metabolizers (part II)' divided by the geometric mean of 'BI 691751 solution (part II)'.|Only extensive CYP2D6 metabolisers were selected: 12 (all) subjects of group 'BI 691751 tablet extensive metabolizers (part II)' and 7 (all investigated) subjects of group 'BI 691751 solution (part II) '.||122.511|74.414|
72486783|NCT01843972|144502153|SUPERIORITY_OR_OTHER||Geometric mean ratio (net)|109.8|STANDARD_DEVIATION|28.8|||TWO_SIDED|90.0|84.376|142.894|||ANOVA||The geometric mean ratio was calculated as the geometric mean of the poor metabolisers divided by the geometric mean of the extensive metabolisers.|Comparison of poor metabolisers (5 (all) subjects of group 'BI 691751 tablet poor metabolizers (part II)') and extensive metabolisers (12 (all) subjects of group 'BI 691751 tablet extensive metabolizers (part II)').||142.894|84.376|
72486784|NCT01843972|144502153|NON_INFERIORITY_OR_EQUIVALENCE|This was non-confirmatory testing.|Slope|1.0312|||||TWO_SIDED|95.0|0.833|1.179|||Regression, Linear|||||1.1790|0.833|
72486785|NCT03805750|144502167|OTHER|||||||0.52|||||||Regression, Logistic|||||||0.52
72486786|NCT01133379|144502202|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.14|STANDARD_ERROR_OF_MEAN|4.75||0.811|TWO_SIDED|95.0|-10.5|8.24||Per statistical analysis plan, if experimental rinse (12027-019) was better than vehicle control at Week 6 (p\<0.05), testing for 12027-019 versus vehicle control proceeded to Week 4. Family-wise error rate was controlled at 0.05.|ANCOVA|Terms included treatment and baseline mean tactile sensitivity (Yeaple probe) score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||8.24|-10.5|0.811
72513746|NCT02724774|144558352|SUPERIORITY|||||||0.154||||||a priori threshold for statistical significance p \< .05|Regression, Linear|||||||.154
72486787|NCT01133379|144502202|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.75|STANDARD_ERROR_OF_MEAN|4.75||0.105|TWO_SIDED|95.0|-17.1|1.63||Per statistical analysis plan, if experimental rinse (12027-020) was better than vehicle control at Week 6 (p\<0.05), testing for 12027-020 versus vehicle control proceeded to Week 4. Family-wise error rate was controlled at 0.05.|ANCOVA|Terms included treatment and baseline mean tactile sensitivity (Yeaple probe) score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||1.63|-17.1|0.105
72486788|NCT01133379|144502203|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.12|STANDARD_ERROR_OF_MEAN|3.969||0.779|TWO_SIDED|95.0|-6.72|8.95||Per statistical analysis plan, if experimental rinse (12027-019) was better than vehicle control at Week 4 (p\<0.05), testing for 12027-019 versus vehicle control proceeded to Week 2. Family-wise error rate was controlled at 0.05.|ANCOVA|Terms included treatment and baseline mean tactile sensitivity (Yeaple probe) score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||8.95|-6.72|0.779
72486789|NCT01133379|144502203|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.92|STANDARD_ERROR_OF_MEAN|3.969||0.217|TWO_SIDED|95.0|-12.8|2.92||Per statistical analysis plan, if experimental rinse (12027-020) was better than vehicle control at Week 4 (p\<0.05), testing for 12027-020 versus vehicle control proceeded to Week 2. Family-wise error rate was controlled at 0.05.|ANCOVA|Terms included treatment and baseline mean tactile sensitivity (Yeaple probe) score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||2.92|-12.8|0.217
72486790|NCT01133379|144502204|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.32|STANDARD_ERROR_OF_MEAN|2.613||0.904|TWO_SIDED|95.0|-4.84|5.47||Per statistical analysis plan, if experimental rinse (12027-019) was better than vehicle control at Week 2 (p\<0.05), testing for 12027-019 versus vehicle control proceeded to Week 1. Family-wise error rate was controlled at 0.05.|ANCOVA|Terms included treatment and baseline mean tactile sensitivity (Yeaple probe) score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||5.47|-4.84|0.904
72513747|NCT02724774|144558353|SUPERIORITY|||||||0.516||||||a priori threshold for statistical significance p \< .05|Regression, Linear|||||||.516
72513748|NCT02724774|144558354|SUPERIORITY||||||<|0.001||||||a priori threshold for statistical significance p \< .05|Regression, Linear|||||||<0.001
72513749|NCT02724774|144558355|SUPERIORITY|||||||0.094||||||a priori threshold for statistical significance p \< .05|Regression, Linear|||||||0.094
72513750|NCT02724774|144558356|SUPERIORITY|||||||0.029|||||||Regression, Linear|||||||0.029
72513751|NCT02724774|144558357|SUPERIORITY|||||||0.389||||||a priori threshold for statistical significance p \< .05|Regression, Linear|||||||.389
72513752|NCT02724774|144558358|SUPERIORITY|||||||0.747||||||a priori threshold for statistical significance p \< .05|Regression, Linear|||||||.747
72513753|NCT05836818|144558361|SUPERIORITY||Adjusted difference|25.1|||<|0.0001|TWO_SIDED|95.0|17.0|33.2|||Regression, Logistic|Mixed effects logistic regression with a random center effect for within-center characteristics, and terms for calendar time and intervention||Adjusted difference 25.1 percentage points||33.2|17|<0.0001
72486791|NCT01133379|144502204|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.99|STANDARD_ERROR_OF_MEAN|2.613||0.129|TWO_SIDED|95.0|-9.15|1.17||Per statistical analysis plan, if experimental rinse (12027-020) was better than vehicle control at Week 2 (p\<0.05), testing for 12027-020 versus vehicle control proceeded to Week 1. Family-wise error rate was controlled at 0.05.|ANCOVA|Terms included treatment and baseline mean tactile sensitivity (Yeaple probe) score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||1.17|-9.15|0.129
72513754|NCT00711269|144558365|SUPERIORITY|One-way Analysis of Variance (ANOVA)|LS Mean difference|-3.5||||0.149|TWO_SIDED|95.0|-8.4|1.3|||ANOVA||\[Not specified\]|||1.3|-8.4|0.149
72513755|NCT00711269|144558365|SUPERIORITY|One-way Analysis of variance (ANOVA)|LS Mean difference|-1.8||||0.462|TWO_SIDED|95.0|-6.6|3.0|||ANOVA|||||3.0|-6.6|0.462
72513756|NCT00711269|144558365|SUPERIORITY|One-way Analysis of variance (ANOVA)|LS Mean difference|-4.6||||0.122|TWO_SIDED|95.0|-10.5|1.2|||ANOVA|||||1.2|-10.5|0.122
72513757|NCT00711269|144558365|SUPERIORITY|Maximum Contrast Method||||||0.235||||||Contrast Factors (Placebo, SM-13496 40-mg, SM-13496 80-mg): (-1, 0, 1) Adjusted P Value: 0.298|Maximum Contrast Method|Contrast (Placebo, SM-13496 40-mg, SM-13496 80-mg):(-2, 1, 1) Raw P Value: 0.108 Adjusted P Value: 0.145||||||0.235
72513758|NCT00711269|144558366|SUPERIORITY|One-way Analysis of variance (ANOVA)|LS Mean difference|-1.4||||0.069|TWO_SIDED|95.0|-2.9|0.1|||ANOVA|||||0.1|-2.9|0.069
72402816|NCT01480076|144311694|SUPERIORITY_OR_OTHER|||||||0.1265|||||||mixed effect model|||Month 9, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % work time missed due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.1265
72486792|NCT01133379|144502205|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.95|STANDARD_ERROR_OF_MEAN|1.336||0.477|TWO_SIDED|95.0|-3.59|1.69||The significance threshold was 0.05. Family-wise error rate was controlled at 0.05.|ANCOVA|Terms included treatment and baseline mean tactile sensitivity (Yeaple probe) score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||1.69|-3.59|0.477
72486793|NCT01133379|144502205|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.96|STANDARD_ERROR_OF_MEAN|1.336||0.472|TWO_SIDED|95.0|-3.6|1.67||The significance threshold was 0.05. Family-wise error rate was controlled at 0.05.|ANCOVA|Terms included treatment and baseline mean tactile sensitivity (Yeaple probe) score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||1.67|-3.60|0.472
72486794|NCT01133379|144502206|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.48|STANDARD_ERROR_OF_MEAN|2.726||0.86|TWO_SIDED|95.0|-5.86|4.9||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline mean tactile sensitivity VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||4.90|-5.86|0.860
72486795|NCT01133379|144502206|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.82|STANDARD_ERROR_OF_MEAN|2.723||0.763|TWO_SIDED|95.0|-6.2|4.55||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline mean tactile sensitivity VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||4.55|-6.20|0.763
72486796|NCT01133379|144502207|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.98|STANDARD_ERROR_OF_MEAN|2.856||0.488|TWO_SIDED|95.0|-7.62|3.66||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline mean tactile sensitivity VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||3.66|-7.62|0.488
72486797|NCT01133379|144502207|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.9|STANDARD_ERROR_OF_MEAN|2.854||0.311|TWO_SIDED|95.0|-8.54|2.73||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline mean tactile sensitivity VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups||2.73|-8.54|0.311
72486798|NCT01133379|144502208|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.81|STANDARD_ERROR_OF_MEAN|3.478||0.604|TWO_SIDED|95.0|-8.68|5.06||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline mean tactile sensitivity VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||5.06|-8.68|0.604
72513759|NCT00711269|144558366|SUPERIORITY|One-way Analysis of variance (ANOVA)|LS Mean difference|-0.8||||0.287|TWO_SIDED|95.0|-2.3|0.7|||ANOVA|||||0.7|-2.3|0.287
72513760|NCT00711269|144558366|SUPERIORITY|One-way Analysis of variance (ANOVA)|LS Mean difference|-2.3||||0.016|TWO_SIDED|95.0|-4.1|-0.4|||ANOVA|||||-0.4|-4.1|0.016
72513761|NCT00711269|144558367|SUPERIORITY|One-way Analysis of variance (ANOVA)|LS Mean difference|-0.7||||0.289|TWO_SIDED|95.0|-2.0|0.6|||ANOVA|||||0.6|-2.0|0.289
72486799|NCT01133379|144502208|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.91|STANDARD_ERROR_OF_MEAN|3.477||0.583|TWO_SIDED|95.0|-4.95|8.78||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline mean tactile sensitivity VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||8.78|-4.95|0.583
72486800|NCT01133379|144502209|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|3.61||0.847|TWO_SIDED|95.0|-7.83|6.43||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline mean tactile sensitivity VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||6.43|-7.83|0.847
72513762|NCT00711269|144558367|SUPERIORITY|One-way Analysis of variance (ANOVA)|LS Mean difference|-0.7||||0.256|TWO_SIDED|95.0|-2.0|0.5|||ANOVA|||||0.5|-2.0|0.256
72513763|NCT00711269|144558367|SUPERIORITY|One-way Analysis of variance (ANOVA)|LS Mean difference|-0.7||||0.352|TWO_SIDED|95.0|-2.3|0.8|||ANOVA|||||0.8|-2.3|0.352
72513764|NCT00711269|144558368|SUPERIORITY|One-way Analysis of variance (ANOVA)|LS Mean difference|-1.4||||0.251|TWO_SIDED|95.0|-3.9|1.0|||ANOVA|||||1.0|-3.9|0.251
72513765|NCT00711269|144558368|SUPERIORITY|One-way Analysis of variance (ANOVA)|LS Mean difference|-0.2||||0.847|TWO_SIDED|95.0|-2.7|2.2|||ANOVA|||||2.2|-2.7|0.847
72513766|NCT00711269|144558368|SUPERIORITY|One-way Analysis of variance (ANOVA)|LS Mean difference|-1.6||||0.292|TWO_SIDED|95.0|-4.6|1.4|||ANOVA|||||1.4|-4.6|0.292
72513767|NCT04593940|144558372|SUPERIORITY||Recovery Rate Ratio|1.122||||0.0793|TWO_SIDED|95.0|0.987|1.275|||Fine-Gray Proportional Hazards Model|||||1.275|0.987|0.0793
72513768|NCT04593940|144558372|SUPERIORITY||Recovery Rate Ratio|1.12||||0.0864|TWO_SIDED|95.0|0.984|1.275|||Fine-Gray Proportional Hazards Model|||||1.275|.984|0.0864
72513769|NCT04593940|144558372|SUPERIORITY||Recovery Rate Ratio|1.006||||0.9354|TWO_SIDED|95.0|0.862|1.176|||Fine-Gray Proportional Hazards Model|||||1.176|0.862|0.9354
72402817|NCT01480076|144311694|SUPERIORITY_OR_OTHER|||||||0.6161|||||||mixed effect model|||Month 9, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % work time missed due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.6161
72513770|NCT04593940|144558373|SUPERIORITY||Odds Ratio (OR)|1.309||||0.0213|TWO_SIDED|95.0|1.041|1.647|||Regression, Logistic|Ordinal logistic regression|Ordinal logistic regression|||1.647|1.041|0.0213
72486801|NCT01133379|144502209|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.36|STANDARD_ERROR_OF_MEAN|3.61||0.708|TWO_SIDED|95.0|-5.77|8.48||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline mean tactile sensitivity VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||8.48|-5.77|0.708
72486802|NCT01133379|144502210|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.46|STANDARD_ERROR_OF_MEAN|2.678||0.36|TWO_SIDED|95.0|-7.75|2.83||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline mean cold air VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||2.83|-7.75|0.360
72486803|NCT01133379|144502210|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.88|STANDARD_ERROR_OF_MEAN|2.679||0.149|TWO_SIDED|95.0|-9.17|1.41||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline mean cold air VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||1.41|-9.17|0.149
72486804|NCT01133379|144502211|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.61|STANDARD_ERROR_OF_MEAN|3.235||0.421|TWO_SIDED|95.0|-9.0|3.78||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline mean cold air VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||3.78|-9.00|0.421
72486805|NCT01133379|144502211|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.66|STANDARD_ERROR_OF_MEAN|3.235||0.26|TWO_SIDED|95.0|-10.0|2.73||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline mean cold air VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||2.73|-10.0|0.260
72486806|NCT01133379|144502212|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|3.601||0.989|TWO_SIDED|95.0|-7.16|7.06||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline mean cold air VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||7.06|-7.16|0.989
72486807|NCT01133379|144502212|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.29|STANDARD_ERROR_OF_MEAN|3.599||0.721|TWO_SIDED|95.0|-8.39|5.82||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline mean cold air VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||5.82|-8.39|0.721
72486808|NCT01133379|144502213|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.21|STANDARD_ERROR_OF_MEAN|3.69||0.743|TWO_SIDED|95.0|-8.5|6.07||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline mean cold air VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||6.07|-8.50|0.743
72486809|NCT01133379|144502213|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.33|STANDARD_ERROR_OF_MEAN|3.688||0.928|TWO_SIDED|95.0|-7.61|6.95||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline mean cold air VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||6.95|-7.61|0.928
72486810|NCT01133379|144502214|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.97|STANDARD_ERROR_OF_MEAN|2.369||0.683|TWO_SIDED|95.0|-3.71|5.65||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline global subjective VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||5.65|-3.71|0.683
72486811|NCT01133379|144502214|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.26|STANDARD_ERROR_OF_MEAN|2.371||0.914|TWO_SIDED|95.0|-4.94|4.42||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline global subjective VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||4.42|-4.94|0.914
72486812|NCT01133379|144502215|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.19|STANDARD_ERROR_OF_MEAN|2.994||0.04|TWO_SIDED|95.0|-12.1|-0.27||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline global subjective VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-0.27|-12.1|0.040
72486813|NCT01133379|144502215|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.1|STANDARD_ERROR_OF_MEAN|2.997||0.043|TWO_SIDED|95.0|-12.0|-0.18||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline global subjective VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-0.18|-12.0|0.043
72513771|NCT04593940|144558373|SUPERIORITY||Odds Ratio (OR)|1.174||||0.1732|TWO_SIDED|95.0|0.932|1.48|||Regression, Logistic|Ordinal logistic regression|Ordinal logistic regression|||1.480|0.932|0.1732
72402818|NCT01480076|144311694|SUPERIORITY_OR_OTHER|||||||0.528|||||||mixed effect model|||Month 9, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % work time missed due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.5280
72402819|NCT01480076|144311694|SUPERIORITY_OR_OTHER||difference of LS means|11.5|STANDARD_ERROR_OF_MEAN|8.51||0.1769|TWO_SIDED||||||mixed effect model|||Month 9, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % work time missed due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.1769
72402820|NCT01480076|144311694|SUPERIORITY_OR_OTHER||difference of LS means|-16.0|STANDARD_ERROR_OF_MEAN|22.24||0.4743|TWO_SIDED||||||mixed effect model|||Month 9, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % work time missed due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.4743
72402821|NCT01480076|144311694|SUPERIORITY_OR_OTHER|||||||0.6901|||||||mixed effect model|||Month 12, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % work time missed due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.6901
72402822|NCT01480076|144311694|SUPERIORITY_OR_OTHER|||||||0.0245|||||||mixed effect model|||Month 12, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % work time missed due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0245
72513772|NCT04593940|144558373|SUPERIORITY||Odds Ratio (OR)|0.944||||0.6823|TWO_SIDED|95.0|0.717|1.243|||Regression, Logistic|Ordinal logistic regression|Ordinal logistic regression|||1.243|0.717|0.6823
72513773|NCT04593940|144558374|SUPERIORITY||Odds Ratio (OR)|0.614||||0.0229|TWO_SIDED|95.0|0.403|0.935|||Regression, Logistic|||||0.935|0.403|0.0229
72513774|NCT04593940|144558374|SUPERIORITY||Odds Ratio (OR)|0.629||||0.0281|TWO_SIDED|95.0|0.416|0.951|||Regression, Logistic|||||0.951|0.416|0.0281
72513775|NCT04593940|144558374|SUPERIORITY||Odds Ratio (OR)|1.167||||0.541|TWO_SIDED|95.0|0.711|1.917|||Regression, Logistic|||||1.917|0.711|0.541
72513776|NCT04593940|144558375|SUPERIORITY||Odds Ratio (OR)|1.435||||0.0032|TWO_SIDED|95.0|1.129|1.825|||Regression, Logistic|Ordinal logistic regression|Ordinal logistic regression|||1.825|1.129|0.0032
72513777|NCT04593940|144558375|SUPERIORITY||Odds Ratio (OR)|1.338||||0.0228|TWO_SIDED|95.0|1.041|1.718|||Regression, Logistic|Ordinal logistic regression|Ordinal logistic regression|||1.718|1.041|0.0228
72513778|NCT04593940|144558375|SUPERIORITY||Odds Ratio (OR)|0.904||||0.4994|TWO_SIDED|95.0|0.675|1.211|||Regression, Logistic|Ordinal logistic regression|Ordinal logistic regression|||1.211|0.675|0.4994
72402823|NCT01480076|144311694|SUPERIORITY_OR_OTHER|||||||0.7707|||||||mixed effect model|||Month 12, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % work time missed due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.7707
72513779|NCT04593940|144558376|SUPERIORITY||Odds Ratio (OR)|0.632||||0.0988|TWO_SIDED|95.0|0.367|1.09|||Regression, Logistic|Ordinal logistic regression|Ordinal logistic regression|||1.090|0.367|0.0988
72513780|NCT04593940|144558376|SUPERIORITY||Odds Ratio (OR)|0.552||||0.0354|TWO_SIDED|95.0|0.317|0.96|||Regression, Logistic|Ordinal logistic regression|Ordinal logistic regression|||0.960|0.317|0.0354
72624130|NCT01892189|144778533|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2446|STANDARD_ERROR_OF_MEAN|0.1447||0.1|TWO_SIDED|95.0|-0.5387|0.0494|||ANOVA||Difference between least square means of TAK-063 30 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Left Thalamus: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.0494|-0.5387|0.100
72513781|NCT04593940|144558376|SUPERIORITY||Odds Ratio (OR)|1.287||||0.4132|TWO_SIDED|95.0|0.703|2.355|||Regression, Logistic|Ordinal logistic regression|Ordinal logistic regression|||2.355|0.703|0.4132
72513782|NCT04593940|144558377|SUPERIORITY||Hazard Ratio (HR)|1.13||||0.1601|TWO_SIDED|95.0|1.0|1.28|||Fine-Gray Proportional Hazards Model|||||1.28|1.00|0.1601
72513783|NCT04593940|144558377|SUPERIORITY||Hazard Ratio (HR)|1.1||||0.355|TWO_SIDED|95.0|0.97|1.24|||Fine-Gray Proportional Hazards Model|||||1.24|0.97|0.3550
72513784|NCT04593940|144558377|SUPERIORITY||Hazard Ratio (HR)|0.92||||0.2386|TWO_SIDED|95.0|0.8|1.07|||Fine-Gray Proportional Hazards Model|||||1.07|0.80|0.2386
72513785|NCT04593940|144558378|SUPERIORITY||Hazard Ratio (HR)|1.11||||0.1519|TWO_SIDED|95.0|0.98|1.26|||Fine-Gray Proportional Hazards Model|||||1.26|0.98|0.1519
72513786|NCT04593940|144558378|SUPERIORITY||Hazard Ratio (HR)|1.11||||0.2605|TWO_SIDED|95.0|0.98|1.26|||Fine-Gray Proportional Hazards Model|||||1.26|0.98|0.2605
72513787|NCT04593940|144558378|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.4359|TWO_SIDED|95.0|0.83|1.13|||Fine-Gray Proportional Hazards Model|||||1.13|0.83|0.4359
72513788|NCT04593940|144558379|SUPERIORITY||Mean Difference (Net)|-0.06||||0.321|TWO_SIDED|95.0|-0.18|0.06|||t-test, 2 sided|||||0.06|-0.18|0.3210
72513789|NCT04593940|144558379|SUPERIORITY||Mean Difference (Net)|0.04||||0.5275|TWO_SIDED|95.0|-0.09|0.17|||t-test, 2 sided|||||0.17|-0.09|0.5275
72513790|NCT04593940|144558379|SUPERIORITY||Mean Difference (Net)|0.0||||0.9993|TWO_SIDED|95.0|-0.15|0.15|||t-test, 2 sided|||||0.15|-0.15|0.9993
72513791|NCT04593940|144558380|SUPERIORITY||Mean Difference (Net)|0.07||||0.4982|TWO_SIDED|95.0|-0.13|0.26|||t-test, 2 sided|||||0.26|-0.13|0.4982
72513792|NCT04593940|144558380|SUPERIORITY||Mean Difference (Net)|0.09||||0.3491|TWO_SIDED|95.0|-0.1|0.29|||t-test, 2 sided|||||0.29|-0.10|0.3491
72513793|NCT04593940|144558380|SUPERIORITY||Mean Difference (Net)|-0.01||||0.902|TWO_SIDED|95.0|-0.25|0.22|||t-test, 2 sided|||||0.22|-0.25|0.9020
72513794|NCT04593940|144558381|SUPERIORITY||Mean Difference (Net)|0.24||||0.0842|TWO_SIDED|95.0|-0.03|0.52|||t-test, 2 sided|||||0.52|-0.03|0.0842
72513795|NCT04593940|144558381|SUPERIORITY||Mean Difference (Net)|0.09||||0.5328|TWO_SIDED|95.0|-0.19|0.37|||t-test, 2 sided|||||0.37|-0.19|0.5328
72513796|NCT04593940|144558381|SUPERIORITY||Mean Difference (Net)|-0.12||||0.4727|TWO_SIDED|95.0|-0.46|0.21|||t-test, 2 sided|||||0.21|-0.46|0.4727
72513797|NCT04593940|144558382|SUPERIORITY||Mean Difference (Net)|0.31||||0.0399|TWO_SIDED|95.0|0.01|0.61|||t-test, 2 sided|||||0.61|0.01|0.0399
72513798|NCT04593940|144558382|SUPERIORITY||Mean Difference (Net)|0.11||||0.4515|TWO_SIDED|95.0|-0.18|0.41|||t-test, 2 sided|||||0.41|-0.18|0.4515
72513799|NCT04593940|144558382|SUPERIORITY||Mean Difference (Net)|-0.07||||0.696|TWO_SIDED|95.0|-0.43|0.29|||t-test, 2 sided|||||0.29|-0.43|0.6960
72513800|NCT04593940|144558383|SUPERIORITY||Mean Difference (Net)|0.26||||0.0903|TWO_SIDED|95.0|-0.04|0.57|||t-test, 2 sided|||||0.57|-0.04|0.0903
72513801|NCT04593940|144558383|SUPERIORITY||Mean Difference (Net)|0.15||||0.348|TWO_SIDED|95.0|-0.16|0.45|||t-test, 2 sided|||||0.45|-0.16|0.3480
72513802|NCT04593940|144558383|SUPERIORITY||Mean Difference (Net)|-0.07||||0.6984|TWO_SIDED|95.0|-0.44|0.29|||t-test, 2 sided|||||0.29|-0.44|0.6984
72624131|NCT01892189|144778533|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.13533||0.113|TWO_SIDED|95.0|-0.495|0.055|||ANOVA||Difference between least square means of TAK-063 3 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Right Thalamus: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.0550|-0.4950|0.113
72513803|NCT04593940|144558384|SUPERIORITY||Mean Difference (Net)|0.32||||0.045|TWO_SIDED|95.0|0.01|0.62|||t-test, 2 sided|||||0.62|0.01|0.0450
72513804|NCT04593940|144558384|SUPERIORITY||Mean Difference (Net)|0.19||||0.2462|TWO_SIDED|95.0|-0.13|0.5|||t-test, 2 sided|||||0.50|-0.13|0.2462
72513805|NCT04593940|144558384|SUPERIORITY||Mean Difference (Net)|-0.23||||0.2304|TWO_SIDED|95.0|-0.61|0.15|||t-test, 2 sided|||||0.15|-0.61|0.2304
72513806|NCT04593940|144558385|SUPERIORITY||Mean Difference (Net)|0.35||||0.0313|TWO_SIDED|95.0|0.03|0.66|||t-test, 2 sided|||||0.66|0.03|0.0313
72513807|NCT04593940|144558385|SUPERIORITY||Mean Difference (Net)|0.31||||0.0555|TWO_SIDED|95.0|-0.01|0.63|||t-test, 2 sided|||||0.63|-0.01|0.0555
72513808|NCT04593940|144558385|SUPERIORITY||Mean Difference (Net)|-0.22||||0.271|TWO_SIDED|95.0|-0.6|0.17|||t-test, 2 sided|||||0.17|-0.60|0.2710
72513809|NCT04593940|144558386|SUPERIORITY||Mean Difference (Net)|1.0|||||TWO_SIDED|95.0|0.0|2.0||||||||2.0|-0.0|
72513810|NCT04593940|144558386|SUPERIORITY||Mean Difference (Net)|0.6|||||TWO_SIDED|95.0|-0.5|1.6||||||||1.6|-0.5|
72513811|NCT04593940|144558386|SUPERIORITY||Mean Difference (Net)|-0.5|||||TWO_SIDED|95.0|-1.8|0.7||||||||0.7|-1.8|
72513812|NCT04593940|144558387|SUPERIORITY||Difference in percentages|29.2|||||TWO_SIDED|95.0|-0.4|53.7||||||||53.7|-0.4|
72513813|NCT04593940|144558387|SUPERIORITY||Difference in percentages|14.0|||||TWO_SIDED|95.0|-14.8|40.0||||||||40.0|-14.8|
72513814|NCT04593940|144558387|SUPERIORITY||Difference in percentages|-5.8|||||TWO_SIDED|95.0|-38.7|26.6||||||||26.6|-38.7|
72513815|NCT04593940|144558388|SUPERIORITY||Mean Difference (Net)|1.2|||||TWO_SIDED|95.0|0.2|2.3||||||||2.3|0.2|
72513816|NCT04593940|144558388|SUPERIORITY||Mean Difference (Net)|0.9|||||TWO_SIDED|95.0|-0.1|2.0||||||||2.0|-0.1|
72513817|NCT04593940|144558388|SUPERIORITY||Mean Difference (Net)|-0.7|||||TWO_SIDED|95.0|-2.0|0.6||||||||0.6|-2.0|
72513818|NCT04593940|144558389|SUPERIORITY||Difference in percentages|-7.0|||||TWO_SIDED|95.0|-14.0|0.0||||||||0.0|-14.0|
72513819|NCT04593940|144558389|SUPERIORITY||Difference in percentages|-3.9|||||TWO_SIDED|95.0|-11.1|3.4||||||||3.4|-11.1|
72513820|NCT04593940|144558389|SUPERIORITY||Difference in percentages|-1.0|||||TWO_SIDED|95.0|-10.1|8.1||||||||8.1|-10.1|
72513821|NCT04593940|144558390|SUPERIORITY||Mean Difference (Net)|0.9|||||TWO_SIDED|95.0|-0.1|1.8||||||||1.8|-0.1|
72513822|NCT04593940|144558390|SUPERIORITY||Mean Difference (Net)|0.7|||||TWO_SIDED|95.0|-0.3|1.7||||||||1.7|-0.3|
72513823|NCT04593940|144558390|SUPERIORITY||Mean Difference (Net)|-0.8|||||TWO_SIDED|95.0|-2.0|0.4||||||||0.4|-2.0|
72513824|NCT04593940|144558391|SUPERIORITY||Difference in percentages|-1.1|||||TWO_SIDED|95.0|-5.7|3.5||||||||3.5|-5.7|
72513825|NCT04593940|144558391|SUPERIORITY||Difference in percentages|-1.3|||||TWO_SIDED|95.0|-6.0|3.3||||||||3.3|-6.0|
72513826|NCT04593940|144558391|SUPERIORITY||Difference in percentages|2.2|||||TWO_SIDED|95.0|-3.7|8.0||||||||8.0|-3.7|
72513827|NCT04593940|144558392|SUPERIORITY||Mean Difference (Net)|1.0|||||TWO_SIDED|95.0|0.0|2.0||||||||2.0|-0.0|
72513828|NCT04593940|144558392|SUPERIORITY||Mean Difference (Net)|0.4|||||TWO_SIDED|95.0|-0.7|1.4||||||||1.4|-0.7|
72513829|NCT04593940|144558392|SUPERIORITY||Mean Difference (Net)|-0.1|||||TWO_SIDED|95.0|-1.3|1.1||||||||1.1|-1.3|
72513830|NCT04593940|144558393|SUPERIORITY||Hazard Ratio (HR)|0.878||||0.3169|TWO_SIDED|95.0|0.68|1.133|||Log Rank|||||1.133|0.680|0.3169
72513831|NCT04593940|144558393|SUPERIORITY||Hazard Ratio (HR)|0.863||||0.248|TWO_SIDED|95.0|0.672|1.108|||Log Rank|||||1.108|0.672|0.2480
72513832|NCT04593940|144558393|SUPERIORITY||Hazard Ratio (HR)|1.191||||0.249|TWO_SIDED|95.0|0.885|1.604|||Log Rank|||||1.604|0.885|0.2490
72513833|NCT04593940|144558394|SUPERIORITY||Hazard Ratio (HR)|1.083||||0.5175|TWO_SIDED|95.0|0.85|1.38|||Log Rank|||||1.380|0.850|0.5175
72513834|NCT04593940|144558394|SUPERIORITY||Hazard Ratio (HR)|0.923||||0.5216|TWO_SIDED|95.0|0.722|1.179|||Log Rank|||||1.179|0.722|0.5216
72513835|NCT04593940|144558394|SUPERIORITY||Hazard Ratio (HR)|1.075||||0.6135|TWO_SIDED|95.0|0.812|1.424|||Log Rank|||||1.424|0.812|0.6135
72513836|NCT04593940|144558395|SUPERIORITY||Hazard Ratio (HR)|0.565||||0.3628|TWO_SIDED|95.0|0.165|1.931|||Log Rank|||||1.931|0.165|0.3628
72513837|NCT04593940|144558395|SUPERIORITY||Hazard Ratio (HR)|0.57||||0.3701|TWO_SIDED|95.0|0.167|1.948|||Log Rank|||||1.948|0.167|0.3701
72513838|NCT04593940|144558395|SUPERIORITY||Hazard Ratio (HR)|4.988||||0.0001|TWO_SIDED|95.0|2.211|11.251|||Log Rank|||||11.251|2.211|0.0001
72513839|NCT00621855|144558396|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Cochran-Armitage test for linear trend|||"The proportion of patients who reach this endpoint were analysed by a logistic model for linear trend (dose response).~The null hypothesis is that the relationship between dose level (0mg, 50mg, 75mg, 110mg and 150mg) and the proportions of patients with major and clinically relevant minor bleeding is not linear (slope parameter = 0)"||||<0.001
72402824|NCT01480076|144311694|SUPERIORITY_OR_OTHER|||||||0.4989|||||||mixed effect model|||Month 12, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % work time missed due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.4989
72402825|NCT01480076|144311694|SUPERIORITY_OR_OTHER||difference of LS means|15.2|STANDARD_ERROR_OF_MEAN|7.31||0.0387|TWO_SIDED||||||mixed effect model|||Month 12, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % work time missed due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0387
72402826|NCT01480076|144311694|SUPERIORITY_OR_OTHER||difference of LS means|-11.7|STANDARD_ERROR_OF_MEAN|15.88||0.4635|TWO_SIDED||||||mixed effect model|||Month 12, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % work time missed due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.4635
72402827|NCT01480076|144311695|SUPERIORITY_OR_OTHER|||||||0.1392|||||||mixed effect model|||Overall, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % impairment while working due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.1392
72402828|NCT01480076|144311695|SUPERIORITY_OR_OTHER|||||||0.1448|||||||mixed effect model|||Overall, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % impairment while working due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.1448
72402829|NCT01480076|144311695|SUPERIORITY_OR_OTHER|||||||0.0187|||||||mixed effect model|||Overall, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % impairment while working due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0187
72624132|NCT01892189|144778533|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.0527|STANDARD_ERROR_OF_MEAN|0.14603||0.72|TWO_SIDED|95.0|-0.3495|0.244|||ANOVA||Difference between least square means of TAK-063 10 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Right Thalamus: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.2440|-0.3495|0.720
72402830|NCT01480076|144311695|SUPERIORITY_OR_OTHER|||||||0.292|||||||mixed effect model|||Overall, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % impairment while working due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.2920
72402831|NCT01480076|144311695|SUPERIORITY_OR_OTHER||difference of LS means|4.2|STANDARD_ERROR_OF_MEAN|4.95||0.3968|TWO_SIDED||||||mixed effect model|||Overall, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % impairment while working due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.3968
72402832|NCT01480076|144311695|SUPERIORITY_OR_OTHER||difference of LS means|5.1|STANDARD_ERROR_OF_MEAN|10.95||0.642|TWO_SIDED||||||mixed effect model|||Overall, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % impairment while working due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.6420
72513840|NCT00621855|144558399|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Armitage test for linear trend|||"The proportion of patients who reach this endpoint were analysed by a logistic model for linear trend (dose response).~The null hypothesis is that the relationship between dose level (0mg, 50mg, 75mg, 110mg and 150mg) and the proportions of patients with major and clinically relevant minor bleeding is not linear (slope parameter = 0)"||||<0.001
72513841|NCT00403559|144558432|NON_INFERIORITY|Non-inferiority determined as the F-IGA, IGA, erythema, scaling, and pruritis scores when compared between groups. The Wilcoxon rank sum test stratified baseline seborrheic dermatitis (SD) severity.||||||0.009|||||||Wilcoxon (Mann-Whitney)|||||||.009
72513842|NCT00929734|144558444|SUPERIORITY_OR_OTHER|||||||0.292|TWO_SIDED||||||ANCOVA|||||||0.292
72513843|NCT00929734|144558445|SUPERIORITY_OR_OTHER|||||||0.462|TWO_SIDED||||||ANCOVA|||||||0.462
72513844|NCT00929734|144558446|SUPERIORITY_OR_OTHER|||||||0.017|TWO_SIDED|||||ANCOVA with natural logarithm of hs-CRP (ln hs-CRP)|ANCOVA|||||||0.017
72513845|NCT00929734|144558447|SUPERIORITY_OR_OTHER|||||||0.028|TWO_SIDED|||||ANCOVA with natural logarithm of interleukin 6 (ln IL6)|ANCOVA|||||||0.028
72513846|NCT00980980|144558449|SUPERIORITY_OR_OTHER|||||||0.01|||||||Proportional-hazards models|Proportional-hazards models with shared frailties accounted for clustering within hospitals.||||||0.01
72513847|NCT00414960|144558465|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.4|STANDARD_ERROR_OF_MEAN|4.04||0.556|TWO_SIDED|95.0|-10.64|5.83||P-value is for comparison of change from baseline between enzastaurin and placebo group.|2-sample pooled t-test||Using placebo as a reference group, the mean difference = enzastaurin minus placebo.|||5.83|-10.64|0.556
72486814|NCT01133379|144502216|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.32|STANDARD_ERROR_OF_MEAN|3.522||0.511|TWO_SIDED|95.0|-9.27|4.64||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline global subjective VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||4.64|-9.27|0.511
72486815|NCT01133379|144502216|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.07|STANDARD_ERROR_OF_MEAN|3.526||0.25|TWO_SIDED|95.0|-11.0|2.89||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline global subjective VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||2.89|-11.0|0.250
72486816|NCT01133379|144502217|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.41|STANDARD_ERROR_OF_MEAN|3.684||0.233|TWO_SIDED|95.0|-11.7|2.86||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline global subjective VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||2.86|-11.7|0.233
72486817|NCT01133379|144502217|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.84|STANDARD_ERROR_OF_MEAN|3.687||0.115|TWO_SIDED|95.0|-13.1|1.44||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline global subjective VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||1.44|-13.1|0.115
72486818|NCT00841204|144502227|OTHER|||||||0.0056|||||||Wilcoxon (Mann-Whitney)|||||||0.0056
72513848|NCT04633473|144558489|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.922|TWO_SIDED||||||t-test, 2 sided|Within subjects paired t-tests.||||||0.922
72513849|NCT04633473|144558490|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.521|TWO_SIDED||||||t-test, 2 sided|Within subjects paired t-tests.||||||0.521
72513850|NCT04633473|144558491|SUPERIORITY||Mean Difference (Final Values)|-0.05||||0.678|TWO_SIDED||||||t-test, 2 sided|Within subjects paired t-tests.||||||0.678
72513851|NCT04633473|144558492|SUPERIORITY||Mean Difference (Final Values)|-0.14||||0.326|TWO_SIDED||||||t-test, 2 sided|Within subjects paired t-tests.||||||0.326
72513852|NCT04633473|144558493|SUPERIORITY||Mean Difference (Final Values)|-0.18||||0.09|TWO_SIDED||||||t-test, 2 sided|Within subjects paired t-tests.||||||0.09
72513853|NCT04633473|144558494|SUPERIORITY||Mean Difference (Final Values)|-0.34||||0.154|TWO_SIDED||||||t-test, 2 sided|Within subjects paired t-tests.||||||0.154
72513854|NCT04633473|144558495|SUPERIORITY||Mean Difference (Final Values)|-0.16||||0.309|TWO_SIDED||||||t-test, 2 sided|Within subjects paired t-tests.||||||0.309
72513855|NCT04633473|144558497|SUPERIORITY||Mean Difference (Final Values)|0.26||||0.181|TWO_SIDED||||||t-test, 2 sided|Within subjects paired t-tests.||||||0.181
72513856|NCT04633473|144558498|SUPERIORITY||Mean Difference (Final Values)|0.91||||0.008|TWO_SIDED||||||t-test, 2 sided|Within subjects paired t-tests.||||||0.008
72513857|NCT00242385|144558521|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|To establish bioequivalence in AUC 0-35d divided by the dose administered with a type I error of 5% the calculated two-sided 90% confidence interval were to be contained completely in the margins of equivalence defined as 80% to 125%.|Ratio of Geometric Means|0.928|||||TWO_SIDED|90.0|0.858|1.002||||||||1.002|0.858|
72624133|NCT01892189|144778533|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.183|STANDARD_ERROR_OF_MEAN|0.1387||0.196|TWO_SIDED|95.0|-0.4649|0.0989|||ANOVA||Difference between least square means of TAK-063 30 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Right Thalamus: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.0989|-0.4649|0.196
72513858|NCT00242385|144558522|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|To establish bioequivalence in AUC 0-infinity divided by the dose administered with a type I error of 5% the calculated two-sided 90% confidence interval were to be contained completely in the margins of equivalence defined as 80% to 125%.|Ratio of Geometric Means|0.934|||||TWO_SIDED|90.0|0.855|1.021||||||||1.021|0.855|
72513859|NCT04348591|144558539|SUPERIORITY||Mean Difference (Final Values)|-0.046|STANDARD_ERROR_OF_MEAN|0.037||0.221|TWO_SIDED|95.0|-0.12|0.029||This p value corresponds to the main effect for experimental group; a-priori threshold was .012|Mixed Models Analysis|||A MMANOVA analysis using an unstructured covariance structure examined main effects of experimental group, instruction provided, headache, racial background, and type of neurostimulation administered. HF-HRV was transformed using an lg function for normality.||.029|-.12|.221
72513860|NCT04348591|144558539|SUPERIORITY|This is a within subject analysis that uses data across groups, controlling for the effect of neurostimulation alone, coil to cortex distance, and racial background|Mean Difference (Final Values)|0.059|STANDARD_ERROR_OF_MEAN|0.022||0.008|TWO_SIDED|95.0|0.016|0.103|||Mixed Models Analysis|Comparison between sham neurostimulation and high frequency neurostimulation||A MMANOVA analysis using an unstructured covariance examined the main effect of type of neurostimulation provided||.103|.016|.008
72513861|NCT04348591|144558539|SUPERIORITY|The analysis controls for coil to cortex distance, racial background and effect of neurostimulation alone. It compares sham stimulation with low frequency neurostimulation|Mean Difference (Final Values)|0.07|STANDARD_ERROR_OF_MEAN|0.021||0.001|TWO_SIDED|95.0|0.029|0.111|||Mixed Models Analysis|||A MMANOVA analysis using an unstructured covariance structure examined the main effect of type of neurostimulation provided.||.111|.029|.001
72513862|NCT04348591|144558540|SUPERIORITY||Mean Difference (Final Values)|0.223|STANDARD_ERROR_OF_MEAN|0.232||0.34|TWO_SIDED|95.0|-0.243|0.689|||Mixed Models Analysis||This is the result for the main effect found of group (emotion dysregulation group versus misophonia)|A MMANOVA analysis using an unstructured covariance structure examined changes in SCL between groups, experimental types of neurostimulation, and their interaction, controlling for baseline, racial background, coil to cortex distance, and headache||.689|-.243|.34
72513863|NCT04348591|144558540|SUPERIORITY||Mean Difference (Final Values)|0.493|STANDARD_ERROR_OF_MEAN|0.148||0.001|TWO_SIDED|95.0|0.198|0.787|||Mixed Models Analysis|This is the main effect of neurostimulation condition. Specifically here we show the difference in estimated marginal means between sham and HF-rTMS||A MMANOVA analysis using an unstructured covariance structure examined changes in SCL between groups, experimental types of neurostimulation, and their interaction, controlling for baseline, racial background, coil to cortex distance, and headache||.787|.198|.001
72513864|NCT04348591|144558540|SUPERIORITY||Mean Difference (Final Values)|0.469|STANDARD_ERROR_OF_MEAN|0.144||0.002|TWO_SIDED|95.0|0.182|0.757|||Mixed Models Analysis|This is the main effect of neurostimulation administered, specifically comparing estimated marginal means for sham and LF-rTMS||A MMANOVA analysis using an unstructured covariance structure examined changes in SCL between groups, experimental types of neurostimulation, and their interaction, controlling for baseline, racial background, coil to cortex distance, and headache||.757|.182|.002
72513865|NCT04348591|144558540|SUPERIORITY||Mean Difference (Final Values)|0.73||||0.0005|TWO_SIDED||||||Mixed Models Analysis||mean difference between sham and HF-rTMS for misophonia participants only when downregulating misophonic sounds|The investigators tested the interaction between experimental neurostimulation (sham, active high frequency rTMS, active low frequency rTMS), instruction provided (listen to neutral sound; listen to aversive sound, listen to misophonic sound, downregulate aversive sound, downregulate misophonic sound), and group (misophonic, clinical control) as part of the same MMANOVA analysis described above (i.e., controlling for coil-to-cortex distance, racial background, baseline, \& presence of headache).||||.0005
72513866|NCT04348591|144558542|SUPERIORITY||Mean Difference (Final Values)|0.0563|STANDARD_ERROR_OF_MEAN|0.09853||0.57|TWO_SIDED|95.0|-0.14149|0.25411|||t-test, 2 sided|||An independent samples t-test was conducted to examine differences between groups in BOLD bilateral dlPFC signal during the regulation of misophonic versus aversive sounds. One outlier was removed from the misophonia group to avoid violating the normality assumption.||.25411|-.14149|.57
72513867|NCT04348591|144558543|SUPERIORITY||Mean Difference (Final Values)|0.037293|STANDARD_ERROR_OF_MEAN|0.131419||0.778|TWO_SIDED|95.0|-0.22667|0.301257|||t-test, 2 sided|50 degrees of freedom||An independent samples t-test was conducted to examine differences between groups in vmPFC activation that was greater when downregulating misophonic versus non-misophonic distress. One participant from each group was excluded for being an outlier||0.301257|-0.226670|.778
72513868|NCT04348591|144558544|SUPERIORITY||z score|4.69|||<|0.05|TWO_SIDED||||||mixed effects whole-brain using cluster|||Mixed effects (FSL's FLAME 1; Oxford Univ., UK) whole brain analyses using cluster correction following a voxel-wise Z-score threshold of 2.3.||||<.05
72513869|NCT04348591|144558545|SUPERIORITY||Mean Difference (Final Values)|-0.197|STANDARD_ERROR_OF_MEAN|0.283||0.49|TWO_SIDED|95.0|-0.766|0.372|||Mixed Models Analysis|This is the main effect from the MMANOVA analysis for group difference.||The MMANOVA analysis of SUDS used a Toeplitz covariance structure. The outcome variable was the difference between SUDS after each sound presentation and baseline, controlling for racial background, headache, and coil to cortex difference. Two participants were excluded from this analysis, one in each condition, because they provided outlier data.||.372|-.766|.49
72513870|NCT04348591|144558545|SUPERIORITY||Mean Difference (Final Values)|0.909|STANDARD_ERROR_OF_MEAN|0.147|<|1e-07|TWO_SIDED|95.0|0.62|1.97||This p-value corresponds to the difference between sham and HF-rTMS stimulation|Mixed Models Analysis|||The MMANOVA analysis of SUDS used a Toeplitz covariance structure. This analysis presents the main effect of neurostimulation experimental condition. The outcome variable was the difference between SUDS after each sound presentation and baseline, controlling for racial background, headache, and coil to cortex difference. Two participants were excluded from this analysis, one in each condition, because they provided outlier data.||1.97|.62|<.0000001
72513871|NCT04348591|144558545|SUPERIORITY||Mean Difference (Final Values)|0.331|STANDARD_ERROR_OF_MEAN|0.139||0.018|TWO_SIDED|95.0|0.057|0.605||The test corresponds to the difference between sham and LF-rTMS|Mixed Models Analysis|||The MMANOVA analysis of SUDS used a Toeplitz covariance structure. This analysis presents the main effect of neurostimulation experimental condition. The outcome variable was the difference between SUDS after each sound presentation and baseline, controlling for racial background, headache, and coil to cortex difference. Two participants were excluded from this analysis, one in each condition, because they provided outlier data.||.605|.057|.018
72513872|NCT04348591|144558545|SUPERIORITY||Mean Difference (Final Values)|1.02|||<|1e-06|TWO_SIDED||||||Mixed Models Analysis||For participants with misophonia difference in distress produced by a misophonic sound when downregulating misophonic sounds while receiving sham vs.HF-rTMS|The MMANOVA analysis of SUDS used a Toeplitz covariance structure. This analysis presents the interaction effect of group by neurostimulation experimental condition. The outcome variable was the difference between SUDS after each sound presentation and baseline, controlling for racial background, headache, and coil to cortex difference. Two participants were excluded from this analysis, one in each condition, because they provided outlier data.||||<.000001
72513873|NCT04348591|144558546|SUPERIORITY||Mean Difference (Final Values)|9.53|STANDARD_ERROR_OF_MEAN|1.92|<|0.001|TWO_SIDED|||||This is the result corresponding to the main effect of time in the repeated measures ANCOVA|ANCOVA|||Repeated measures ANOVA (controlling for racial background)||||<.001
72513874|NCT04348591|144558546|SUPERIORITY||||||>|0.012|||||||ANCOVA|This analysis corresponds to the main effect of group.||Repeated measures ANOVA (controlling for racial background)||||>.012
72513875|NCT04348591|144558547|SUPERIORITY|||||||0.78|||||||t-test, 2 sided|||An independent samples t-test was conducted to examine between group differences at the intake assessment on the PROMIS Anxiety subscale||||.78
72513876|NCT04348591|144558547|SUPERIORITY|||||||0.29|||||||t-test, 2 sided|||An independent samples t-test was conducted to examine between group differences at the intake assessment on the PROMIS Depression subscale||||.29
72513877|NCT04348591|144558547|SUPERIORITY|||||||0.64|||||||t-test, 2 sided|||An independent samples t-test was conducted to examine between group differences at the intake assessment on the PROMIS Fatigue subscale||||.64
72513878|NCT04348591|144558547|SUPERIORITY|||||||0.16|||||||t-test, 2 sided|||An independent samples t-test was conducted to examine between group differences at the intake assessment on the PROMIS Sleep disturbance subscale||||.16
72513879|NCT04348591|144558547|SUPERIORITY|||||||0.56|||||||t-test, 2 sided|||An independent samples t-test was conducted to examine between group differences at the intake assessment on the PROMIS Ability to partake in social roles subscale||||.56
72513880|NCT02104804|144558553|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-0.58|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|95.0|-0.72|-0.45|||ANCOVA|||||-0.45|-0.72|<0.001
72513881|NCT02104804|144558554|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-6133.2|STANDARD_ERROR_OF_MEAN|781.06|<|0.001|TWO_SIDED|95.0|-7668.5|-4597.9|||ANCOVA|||||-4597.9|-7668.5|<0.001
72486819|NCT00841204|144502228|OTHER|||||||0.386|||||||Wilcoxon (Mann-Whitney)|||||||0.386
72486820|NCT00841204|144502229|OTHER||||||<|0.05|||||||Regression, Linear|||||||<0.05
72513882|NCT02104804|144558555|SUPERIORITY_OR_OTHER||Difference in Least squares mean|-39.11|STANDARD_ERROR_OF_MEAN|5.24|<|0.001|TWO_SIDED|95.0|-49.41|-28.82|||ANCOVA|||||-28.82|-49.41|<0.001
72513883|NCT02104804|144558556|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.8||||0.002|TWO_SIDED|95.0|3.1|12.6|||Difference in proportions|||||12.6|3.1|0.002
72513884|NCT02104804|144558557|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-15.88|STANDARD_ERROR_OF_MEAN|2.88|<|0.001|TWO_SIDED|95.0|-21.53|-10.22|||ANCOVA|||||-10.22|-21.53|<0.001
72486821|NCT00841204|144502230|OTHER|||||||0.58|||||||Regression, Linear|||||||0.58
72486822|NCT00841204|144502231|OTHER|||||||0.12|||||||Regression, Linear|||||||0.12
72486823|NCT05470465|144502233|SUPERIORITY||Mean Difference (Final Values)|-6.5|||<|0.001|ONE_SIDED|97.5||-3.1||To demonstrate an effect of oxycodone with paroxetine compared to oxycodone alone, it is necessary that the upper bound of the one-sided 97.5% confidence interval (CI) in the least-square mean VE55 difference between treatments \< 0 L/min.|Mixed Models Analysis|The Kenward-Roger approximation will be used to estimate denominator degrees of freedom for tests of fixed effects.|Comparison was the effect of oxycodone and paroxetine compared to oxycodone and placebo.|Sample size and power were calculated based on 2 primary outcomes (day 20 and day 21) with adjustment for multiplicity (α=.025). The assessments with paroxetine or escitalopram were considered as separate experiments. A sample size of 20 participants was determined to have 90 percent power at a 1-sided significance level to detect a 4 L/min decrease in the primary end point (ventilation at 55 mmHg end-tidal carbon dioxide) assuming a standard deviation of 5 L/min.||-3.1||<0.001
72486824|NCT05470465|144502233|SUPERIORITY||Mean Difference (Final Values)|-5.5||||0.001|ONE_SIDED|97.5||-2.1||To demonstrate an effect of oxycodone with escitalopram compared to oxycodone alone, it is necessary that the upper bound of the one-sided 97.5% confidence interval (CI) in the least-square mean VE55 difference between treatments \< 0 L/min.|Mixed Models Analysis|The Kenward-Roger approximation will be used to estimate denominator degrees of freedom for tests of fixed effects.|Comparison was the effect of oxycodone and escitalopram compared to oxycodone and placebo.|Sample size and power were calculated based on 2 primary outcomes (day 20 and day 21) with adjustment for multiplicity (α=.025). The assessments with paroxetine or escitalopram were considered as separate experiments. A sample size of 20 participants was determined to have 90 percent power at a 1-sided significance level to detect a 4 L/min decrease in the primary end point (ventilation at 55 mmHg end-tidal carbon dioxide) assuming a standard deviation of 5 L/min.||-2.1||0.001
72486825|NCT05470465|144502234|SUPERIORITY||Mean Difference (Final Values)|-6.5||||0.002|ONE_SIDED|97.5||-2.1||To demonstrate an effect of paroxetine compared to placebo, it is necessary that the upper bound of the one-sided 97.5% confidence interval (CI) in the least-square mean VE55 difference between treatments \< 0 L/min.|Mixed Models Analysis|The Kenward-Roger approximation will be used to estimate denominator degrees of freedom for tests of fixed effects.|Comparison was the effect of paroxetine compared to placebo.|Sample size and power were calculated based on 2 primary outcomes (day 20 and day 21) with adjustment for multiplicity (α=.025). The assessments with paroxetine or escitalopram were considered as separate experiments. A sample size of 20 participants was determined to have 90 percent power at a 1-sided significance level to detect a 4 L/min decrease in the primary end point (ventilation at 55 mmHg end-tidal carbon dioxide) assuming a standard deviation of 5 L/min.||-2.1||0.002
72486826|NCT05470465|144502234|SUPERIORITY||Mean Difference (Final Values)|-6.9||||0.003|ONE_SIDED|97.5||-2.5||To demonstrate an effect of escitalopram compared to placebo, it is necessary that the upper bound of the one-sided 97.5% confidence interval (CI) in the least-square mean VE55 difference between treatments \< 0 L/min.|Mixed Models Analysis|The Kenward-Roger approximation will be used to estimate denominator degrees of freedom for tests of fixed effects.|Comparison was the effect of escitalopram compared to placebo.|Sample size and power were calculated based on 2 primary outcomes (day 20 and day 21) with adjustment for multiplicity (α=.025). The assessments with paroxetine or escitalopram were considered as separate experiments. A sample size of 20 participants was determined to have 90 percent power at a 1-sided significance level to detect a 4 L/min decrease in the primary end point (ventilation at 55 mmHg end-tidal carbon dioxide) assuming a standard deviation of 5 L/min.||-2.5||0.003
72486827|NCT05470465|144502235|SUPERIORITY||Mean Difference (Final Values)|-7.1|||<|0.001|ONE_SIDED|97.5||-4.1||Secondary analyses are not adjusted for multiplicity. To demonstrate an effect of oxycodone and paroxetine compared to oxycodone, the upper bound of the one-sided 97.5% CI in the least-square mean VE55 difference between treatments \< 0 L/min.|Mixed Models Analysis|The Kenward-Roger approximation will be used to estimate denominator degrees of freedom for tests of fixed effects.|Comparison was the effect of oxycodone and paroxetine compared to oxycodone and placebo at day 6 at 5 hours.|Sample size and power were calculated based on 2 primary outcomes (day 20 and day 21) with adjustment for multiplicity (α=.025). The assessments with paroxetine or escitalopram were considered as separate experiments. A sample size of 20 participants was determined to have 90 percent power at a 1-sided significance level to detect a 4 L/min decrease in the primary end point (ventilation at 55 mmHg end-tidal carbon dioxide) assuming a standard deviation of 5 L/min.||-4.1||<0.001
72486828|NCT05470465|144502235|SUPERIORITY||Mean Difference (Final Values)|-5.6|||<|0.001|ONE_SIDED|97.5||-2.6||Secondary analyses are not adjusted for multiplicity. To demonstrate an effect of oxycodone and escitalopram compared to oxycodone, the upper bound of the one-sided 97.5% CI in the least-square mean VE55 difference between treatments \< 0 L/min.|Mixed Models Analysis|The Kenward-Roger approximation will be used to estimate denominator degrees of freedom for tests of fixed effects.|Comparison was the effect of oxycodone and escitalopram compared to oxycodone and placebo at day 6 at 5 hours.|Sample size and power were calculated based on 2 primary outcomes (day 20 and day 21) with adjustment for multiplicity (α=.025). The assessments with paroxetine or escitalopram were considered as separate experiments. A sample size of 20 participants was determined to have 90 percent power at a 1-sided significance level to detect a 4 L/min decrease in the primary end point (ventilation at 55 mmHg end-tidal carbon dioxide) assuming a standard deviation of 5 L/min.||-2.6||<0.001
72567913|NCT02037165|144667467|SUPERIORITY_OR_OTHER||adjusted mean difference|-0.17|STANDARD_ERROR_OF_MEAN|2.0277|||TWO_SIDED|95.0|-4.2|3.8|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 3:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||3.8|-4.2|
72402833|NCT01480076|144311695|SUPERIORITY_OR_OTHER|||||||0.01|||||||mixed effect model|||Month 3, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % impairment while working due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0100
72402834|NCT01480076|144311695|SUPERIORITY_OR_OTHER|||||||0.8634|||||||mixed effect model|||Month 3, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % impairment while working due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.8634
72402835|NCT01480076|144311695|SUPERIORITY_OR_OTHER|||||||0.0134|||||||mixed effect model|||Month 3, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % impairment while working due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0134
72567914|NCT02037165|144667467|SUPERIORITY_OR_OTHER||adjusted mean difference|1.2|STANDARD_ERROR_OF_MEAN|2.0276|||TWO_SIDED|95.0|-2.8|5.2|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 4:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||5.2|-2.8|
72567915|NCT02037165|144667467|SUPERIORITY_OR_OTHER||adjusted mean difference|-0.59|STANDARD_ERROR_OF_MEAN|2.0277|||TWO_SIDED|95.0|-4.6|3.4|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 5:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||3.4|-4.6|
72567916|NCT02037165|144667467|SUPERIORITY_OR_OTHER||adjusted mean difference|-2.88|STANDARD_ERROR_OF_MEAN|2.0278|||TWO_SIDED|95.0|-6.9|1.1|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 6:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||1.1|-6.9|
72567917|NCT02037165|144667467|SUPERIORITY_OR_OTHER||adjusted mean difference|0.43|STANDARD_ERROR_OF_MEAN|2.0279|||TWO_SIDED|95.0|-3.6|4.4|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 22:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||4.4|-3.6|
72402836|NCT01480076|144311695|SUPERIORITY_OR_OTHER|||||||0.8147|||||||mixed effect model|||Month 3, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % impairment while working due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.8147
72402837|NCT01480076|144311695|SUPERIORITY_OR_OTHER||difference of LS means|-5.1|STANDARD_ERROR_OF_MEAN|6.06||0.4035|TWO_SIDED||||||mixed effect model|||Month 3, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % impairment while working due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.4035
72402838|NCT01480076|144311695|SUPERIORITY_OR_OTHER||difference of LS means|-4.8|STANDARD_ERROR_OF_MEAN|14.25||0.7385|TWO_SIDED||||||mixed effect model|||Month 3, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % impairment while working due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.7385
72402839|NCT01480076|144311695|SUPERIORITY_OR_OTHER|||||||0.0139|||||||mixed effect model|||Month 6, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % impairment while working due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0139
72513885|NCT02104804|144558558|SUPERIORITY_OR_OTHER||Difference in Least squares mean|-0.13|STANDARD_ERROR_OF_MEAN|0.16||0.43|TWO_SIDED|95.0|-0.44|0.19|||ANCOVA|||||0.19|-0.44|0.430
72513886|NCT01348425|144558559|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin is +/- 10%, type I error is assumed to be 0.05, with a power of 0.8.|Mean Difference (Final Values)|0.7|STANDARD_DEVIATION|4.1|<|0.01|TWO_SIDED|95.0|-2.0|3.5||Schuirman's TOST equivalence test on change in stent length upon deployment between longer and shorter stents.|t-test, 2 sided|To test the hypothesis whether the percent change in stent length is contained within \[-10%, 10%\].||The alternative hypothesis is equivalence in mean change in stent length upon deployment between longer and shorter stents, i.e., the difference in mean change between the longer and shorter stents is close to 0. Thus, a small p-value indicates a 95% confidence interval covers 0.||3.5|-2.0|<0.01
72513887|NCT02720016|144558561|SUPERIORITY||Slope|-3.216|STANDARD_ERROR_OF_MEAN|1.3||0.016|TWO_SIDED||||||Mixed-effects regression|Models included random intercepts||Analyses were pooled across 50 imputed data sets. We used piecewise/spline mixed-effects regression models: one slope estimated from baseline to post (treatment impacts), with a separate slope estimated from post to 6-months (maintenance).||||.016
72513888|NCT02720016|144558561|SUPERIORITY||Slope|-4.11|STANDARD_ERROR_OF_MEAN|1.308||0.002|TWO_SIDED||||||Mixed-effects regression|Models included random intercepts||Analyses were pooled across 50 imputed data sets. We used piecewise/spline mixed-effects regression models: one slope estimated from baseline to post (treatment impacts), with a separate slope estimated from post to 6-months (maintenance).||||.002
72513889|NCT02720016|144558561|SUPERIORITY||Slope|-0.894|STANDARD_ERROR_OF_MEAN|1.296||0.492|TWO_SIDED||||||Mixed-effects regression|Models included random intercepts||Analyses were pooled across 50 imputed data sets. We used piecewise/spline mixed-effects regression models: one slope estimated from baseline to post (treatment impacts), with a separate slope estimated from post to 6-months (maintenance).||||.492
72513890|NCT02720016|144558566|SUPERIORITY||Slope|-0.352|STANDARD_ERROR_OF_MEAN|2.172||0.872|TWO_SIDED||||||Mixed-effects regression|Models included random intercepts and included partners nested within couples||Analyses were pooled across 50 imputed data sets. We used piecewise/spline mixed-effects regression models: one slope estimated from baseline to post (treatment impacts), with a separate slope estimated from post to 6-months (maintenance).||||.872
72513891|NCT02720016|144558566|SUPERIORITY||Slope|-0.931|STANDARD_ERROR_OF_MEAN|2.296||0.686|TWO_SIDED||||||Mixed-effects regression|Models included random intercepts and included partners nested within couples||Analyses were pooled across 50 imputed data sets. We used piecewise/spline mixed-effects regression models: one slope estimated from baseline to post (treatment impacts), with a separate slope estimated from post to 6-months (maintenance).||||.686
72513892|NCT02720016|144558566|SUPERIORITY||Slope|-0.579|STANDARD_ERROR_OF_MEAN|2.256||0.798|TWO_SIDED||||||Mixed-effects regression|Models included random intercepts and included partners nested within couples||Analyses were pooled across 50 imputed data sets. We used piecewise/spline mixed-effects regression models: one slope estimated from baseline to post (treatment impacts), with a separate slope estimated from post to 6-months (maintenance).||||.798
72513893|NCT02720016|144558571|SUPERIORITY||Slope|-1.213|STANDARD_ERROR_OF_MEAN|2.518||0.631|TWO_SIDED||||||Mixed-effects regression|Models included random intercepts||Analyses were pooled across 50 imputed data sets. We used piecewise/spline mixed-effects regression models: one slope estimated from baseline to post (treatment impacts), with a separate slope estimated from post to 6-months (maintenance).||||.631
72513894|NCT02720016|144558571|SUPERIORITY||Slope|-1.461|STANDARD_ERROR_OF_MEAN|2.495||0.56|TWO_SIDED||||||Mixed-effects regression|Models included random intercepts||Analyses were pooled across 50 imputed data sets. We used piecewise/spline mixed-effects regression models: one slope estimated from baseline to post (treatment impacts), with a separate slope estimated from post to 6-months (maintenance).||||.560
72513895|NCT02720016|144558571|SUPERIORITY||Slope|-0.248|STANDARD_ERROR_OF_MEAN|2.536||0.922|TWO_SIDED||||||Mixed-effects regression|Models included random intercepts||Analyses were pooled across 50 imputed data sets. We used piecewise/spline mixed-effects regression models: one slope estimated from baseline to post (treatment impacts), with a separate slope estimated from post to 6-months (maintenance).||||.922
72513896|NCT01968954|144558607|SUPERIORITY_OR_OTHER||Least Square (LS) Mean Difference|-57.0|STANDARD_ERROR_OF_MEAN|2.0|<|0.001|TWO_SIDED|95.0|-61.0|-53.1|||Mixed Model Repeated Measures (MMRM)|||LS-mean difference, associated 95% confidence intervals and p values from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region, triglyceride subgroup.||-53.1|-61.0|<0.001
72513897|NCT01968954|144558608|SUPERIORITY_OR_OTHER||LS mean difference|-36.2|STANDARD_ERROR_OF_MEAN|1.33|<|0.001|TWO_SIDED|95.0|-38.8|-33.6|||MMRM|||Week 12: LS-mean difference, associated 95% confidence intervals and p values from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region, triglyceride subgroup.||-33.6|-38.8|<0.001
72577012|NCT00261443|144680743|SUPERIORITY_OR_OTHER_LEGACY|||||||0.735||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Highest Value of Change in Leukocytes, Phase 3||||0.735
72577013|NCT00261443|144680743|SUPERIORITY_OR_OTHER_LEGACY|||||||0.505||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Lowest Value of Change in Leukocytes, Phase 3||||0.505
72577014|NCT00261443|144680745|SUPERIORITY_OR_OTHER_LEGACY|||||||0.213||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Baseline QTc Bazett||||0.213
72577015|NCT00261443|144680745|SUPERIORITY_OR_OTHER_LEGACY|||||||0.708||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison, Change from Baseline in QTc Bazett at Week 52 (LOCF)||||0.708
72513898|NCT01968954|144558608|SUPERIORITY_OR_OTHER||LS mean difference|-34.7|STANDARD_ERROR_OF_MEAN|1.52|||TWO_SIDED|95.0|-37.7|-31.7||||||Week 24: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region, triglyceride subgroup.||-31.7|-37.7|
72513899|NCT01968954|144558608|SUPERIORITY_OR_OTHER||LS mean difference|-29.0|STANDARD_ERROR_OF_MEAN|1.69|||TWO_SIDED|95.0|-32.3|-25.7||||||Week 52: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region, triglyceride subgroup.||-25.7|-32.3|
72577016|NCT00261443|144680745|SUPERIORITY_OR_OTHER_LEGACY|||||||0.107||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Highest Value of Change in QTc Bazett, Phase 3||||0.107
72513900|NCT01968954|144558609|SUPERIORITY_OR_OTHER||LS mean difference|-51.6|STANDARD_ERROR_OF_MEAN|1.8|<|0.001|TWO_SIDED|95.0|-55.2|-48.1|||MMRM|||Week 12: LS-mean difference, associated 95% confidence intervals and p values from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region, triglyceride subgroup.||-48.1|-55.2|<0.001
72513901|NCT01968954|144558609|SUPERIORITY_OR_OTHER||LS mean Difference|-50.6|STANDARD_ERROR_OF_MEAN|2.15|||TWO_SIDED|95.0|-54.9|-46.4||||||Week 24: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region, triglyceride subgroup.||-46.4|-54.9|
72513902|NCT01968954|144558609|SUPERIORITY_OR_OTHER||LS mean difference|-41.2|STANDARD_ERROR_OF_MEAN|2.38|||TWO_SIDED|95.0|-45.8|-36.5||||||Week 52:LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region, triglyceride subgroup.||-36.5|-45.8|
72513903|NCT01968954|144558610|SUPERIORITY_OR_OTHER||LS mean difference|-51.5|STANDARD_ERROR_OF_MEAN|1.84|<|0.001|TWO_SIDED|95.0|-55.1|-47.9|||MMRM|||Week 12: LS-mean difference, associated 95% confidence intervals and p values from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region, triglyceride subgroup.||-47.9|-55.1|<0.001
72513904|NCT01968954|144558610|SUPERIORITY_OR_OTHER||LS mean difference|-50.6|STANDARD_ERROR_OF_MEAN|2.05|||TWO_SIDED|95.0|-54.6|-46.6||||||Week 24: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region, triglyceride subgroup.||-46.6|-54.6|
72513905|NCT01968954|144558610|SUPERIORITY_OR_OTHER||LS mean difference|-40.8|STANDARD_ERROR_OF_MEAN|2.26|||TWO_SIDED|95.0|-45.2|-36.3||||||Week 52: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region, triglyceride subgroup.||-36.3|-45.2|
72513906|NCT01968954|144558611|SUPERIORITY_OR_OTHER||LS mean difference|-2.9|STANDARD_ERROR_OF_MEAN|16.55||0.86|TWO_SIDED|95.0|-35.4|29.5|||MMRM|||Week 12: LS-mean difference, associated 95% confidence intervals and p values from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region, triglyceride subgroup.||29.5|-35.4|0.860
72513907|NCT01968954|144558611|SUPERIORITY_OR_OTHER||LS mean difference|2.1|STANDARD_ERROR_OF_MEAN|25.11|||TWO_SIDED|95.0|-47.2|51.4||||||Week 24: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region, triglyceride subgroup.||51.4|-47.2|
72513908|NCT01968954|144558611|SUPERIORITY_OR_OTHER||LS mean difference|12.9|STANDARD_ERROR_OF_MEAN|29.25|||TWO_SIDED|95.0|-44.5|70.4||||||Week 52: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region, triglyceride subgroup.||70.4|-44.5|
72513909|NCT01968954|144558612|SUPERIORITY_OR_OTHER||LS mean difference|4.7|STANDARD_ERROR_OF_MEAN|1.19|<|0.001|TWO_SIDED|95.0|2.4|7.0|||MMRM|||Week 12: LS-mean difference, associated 95% confidence intervals and p values from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region, triglyceride subgroup.||7.0|2.4|<0.001
72513910|NCT01968954|144558612|SUPERIORITY_OR_OTHER||LS mean difference|6.8|STANDARD_ERROR_OF_MEAN|1.18|||TWO_SIDED|95.0|4.5|9.1||||||Week 24: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region, triglyceride subgroup.||9.1|4.5|
72513911|NCT01968954|144558612|SUPERIORITY_OR_OTHER||LS mean difference|3.3|STANDARD_ERROR_OF_MEAN|1.25|||TWO_SIDED|95.0|0.9|5.8||||||Week 52: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region, triglyceride subgroup.||5.8|0.9|
72513912|NCT01968954|144558613|SUPERIORITY_OR_OTHER||LS mean difference|-59.1|STANDARD_ERROR_OF_MEAN|2.19|<|0.001|TWO_SIDED|95.0|-63.4|-54.8|||MMRM|||LS-mean difference, associated 95% confidence intervals and p values from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region, triglyceride subgroup.||-54.8|-63.4|<0.001
72513913|NCT01968954|144558614|SUPERIORITY_OR_OTHER||LS mean difference|-48.7|STANDARD_ERROR_OF_MEAN|4.72|<|0.001|TWO_SIDED|95.0|-58.0|-39.3|||MMRM|||LS-mean difference, associated 95% confidence intervals and p values from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region, triglyceride subgroup.||-39.3|-58.0|<0.001
72513914|NCT01968954|144558615|SUPERIORITY_OR_OTHER||LS mean difference|-56.0|STANDARD_ERROR_OF_MEAN|2.45|||TWO_SIDED|95.0|-60.8|-51.2||||||Week 24: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region, triglyceride subgroup.||-51.2|-60.8|
72577017|NCT00261443|144680746|SUPERIORITY_OR_OTHER_LEGACY|||||||0.205||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Baseline QTc (0.33)||||0.205
72402840|NCT01480076|144311695|SUPERIORITY_OR_OTHER|||||||0.5207|||||||mixed effect model|||Month 6, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % impairment while working due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.5207
72486829|NCT05470465|144502236|SUPERIORITY||Mean Difference (Final Values)|-10.1|||<|0.001|ONE_SIDED|97.5||-5.9||Secondary analyses are not adjusted for multiplicity. To demonstrate an effect of oxycodone and paroxetine compared to oxycodone, the upper bound of the one-sided 97.5% CI in the least-square mean VE55 difference between treatments \< 0 L/min.|Mixed Models Analysis|The Kenward-Roger approximation will be used to estimate denominator degrees of freedom for tests of fixed effects.|Comparison was the effect of oxycodone and paroxetine compared to oxycodone and placebo at day 12 at 5 hours.|Sample size and power were calculated based on 2 primary outcomes (day 20 and day 21) with adjustment for multiplicity (α=.025). The assessments with paroxetine or escitalopram were considered as separate experiments. A sample size of 20 participants was determined to have 90 percent power at a 1-sided significance level to detect a 4 L/min decrease in the primary end point (ventilation at 55 mmHg end-tidal carbon dioxide) assuming a standard deviation of 5 L/min.||-5.9||<0.001
72486830|NCT05470465|144502236|SUPERIORITY||Mean Difference (Final Values)|-6.9||||0.003|ONE_SIDED|97.5||-2.7||Secondary analyses are not adjusted for multiplicity. To demonstrate an effect of oxycodone and escitalopram compared to oxycodone, the upper bound of the one-sided 97.5% CI in the least-square mean VE55 difference between treatments \< 0 L/min.|Mixed Models Analysis|The Kenward-Roger approximation will be used to estimate denominator degrees of freedom for tests of fixed effects.|Comparison was the effect of oxycodone and paroxetine compared to oxycodone and placebo at day 12 at 5 hours.|Sample size and power were calculated based on 2 primary outcomes (day 20 and day 21) with adjustment for multiplicity (α=.025). The assessments with paroxetine or escitalopram were considered as separate experiments. A sample size of 20 participants was determined to have 90 percent power at a 1-sided significance level to detect a 4 L/min decrease in the primary end point (ventilation at 55 mmHg end-tidal carbon dioxide) assuming a standard deviation of 5 L/min.||-2.7||0.003
72486831|NCT05470465|144502237|SUPERIORITY||Mean Difference (Final Values)|-11.6|||<|0.001|ONE_SIDED|97.5||-6.5||Secondary analyses are not adjusted for multiplicity. To demonstrate an effect of paroxetine compared to placebo, the upper bound of the one-sided 97.5% CI in the least-square mean VE55 difference between treatments \< 0 L/min.|Mixed Models Analysis|The Kenward-Roger approximation will be used to estimate denominator degrees of freedom for tests of fixed effects.|Comparison was the effect of paroxetine compared to placebo at day 5 at 5 hours.|Sample size and power were calculated based on 2 primary outcomes (day 20 and day 21) with adjustment for multiplicity (α=.025). The assessments with paroxetine or escitalopram were considered as separate experiments. A sample size of 20 participants was determined to have 90 percent power at a 1-sided significance level to detect a 4 L/min decrease in the primary end point (ventilation at 55 mmHg end-tidal carbon dioxide) assuming a standard deviation of 5 L/min.||-6.5||<0.001
72486832|NCT05470465|144502237|SUPERIORITY||Mean Difference (Final Values)|-14.0|||<|0.001|ONE_SIDED|97.5||-9.0||Secondary analyses are not adjusted for multiplicity. To demonstrate an effect of escitalopram compared to placebo, the upper bound of the one-sided 97.5% CI in the least-square mean VE55 difference between treatments \< 0 L/min.|Mixed Models Analysis|The Kenward-Roger approximation will be used to estimate denominator degrees of freedom for tests of fixed effects.|Comparison was the effect of escitalopram compared to placebo at day 5 at 5 hours.|Sample size and power were calculated based on 2 primary outcomes (day 20 and day 21) with adjustment for multiplicity (α=.025). The assessments with paroxetine or escitalopram were considered as separate experiments. A sample size of 20 participants was determined to have 90 percent power at a 1-sided significance level to detect a 4 L/min decrease in the primary end point (ventilation at 55 mmHg end-tidal carbon dioxide) assuming a standard deviation of 5 L/min.||-9.0||<0.001
72486833|NCT05470465|144502238|SUPERIORITY||Mean Difference (Final Values)|-14.1|||<|0.001|ONE_SIDED|97.5||-8.5||Secondary analyses are not adjusted for multiplicity. To demonstrate an effect of paroxetine compared to placebo, the upper bound of the one-sided 97.5% CI in the least-square mean VE55 difference between treatments \< 0 L/min.|Mixed Models Analysis|The Kenward-Roger approximation will be used to estimate denominator degrees of freedom for tests of fixed effects.|Comparison was the effect of paroxetine compared to placebo at day 11 at 5 hours.|Sample size and power were calculated based on 2 primary outcomes (day 20 and day 21) with adjustment for multiplicity (α=.025). The assessments with paroxetine or escitalopram were considered as separate experiments. A sample size of 20 participants was determined to have 90 percent power at a 1-sided significance level to detect a 4 L/min decrease in the primary end point (ventilation at 55 mmHg end-tidal carbon dioxide) assuming a standard deviation of 5 L/min.||-8.5||<0.001
72486834|NCT05470465|144502238|SUPERIORITY||Mean Difference (Final Values)|-9.5|||<|0.001|ONE_SIDED|97.5||-3.8||Secondary analyses are not adjusted for multiplicity. To demonstrate an effect of escitalopram compared to placebo, the upper bound of the one-sided 97.5% CI in the least-square mean VE55 difference between treatments \< 0 L/min.|Mixed Models Analysis|The Kenward-Roger approximation will be used to estimate denominator degrees of freedom for tests of fixed effects.|Comparison was the effect of escitalopram compared to placebo at day 11 at 5 hours.|Sample size and power were calculated based on 2 primary outcomes (day 20 and day 21) with adjustment for multiplicity (α=.025). The assessments with paroxetine or escitalopram were considered as separate experiments. A sample size of 20 participants was determined to have 90 percent power at a 1-sided significance level to detect a 4 L/min decrease in the primary end point (ventilation at 55 mmHg end-tidal carbon dioxide) assuming a standard deviation of 5 L/min.||-3.8||<0.001
72486835|NCT02142738|144502239|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.5|||<|0.001|TWO_SIDED|95.0|0.37|0.68||One-sided p-value based on log-rank test|Regression, Cox|Treatment as a covariate stratified by geographic region (East Asia vs. non-East Asia), ECOG PS (0 vs. 1) and histology (squamous vs. nonsquamous)||||0.68|0.37|<0.001
72513915|NCT01968954|144558615|SUPERIORITY_OR_OTHER||LS mean difference|-46.4|STANDARD_ERROR_OF_MEAN|2.77|||TWO_SIDED|95.0|-51.8|-41.0||||||Week 52: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region, triglyceride subgroup.||-41.0|-51.8|
72513916|NCT01968954|144558616|SUPERIORITY_OR_OTHER||LS mean difference|-57.6|STANDARD_ERROR_OF_MEAN|2.82|||TWO_SIDED|95.0|-63.1|-52.0||||||TG \<200 mg/dL (Week 24): LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region.||-52.0|-63.1|
72486836|NCT02142738|144502240|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.63||||0.002|TWO_SIDED|95.0|0.47|0.86||One-sided p-value based on log-rank test|Regression, Cox|Treatment as a covariate stratified by geographic region (East Asia vs. non-East Asia), ECOG PS (0 vs. 1) and histology (squamous vs. nonsquamous)||||0.86|0.47|0.002
72486837|NCT02142738|144502241|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentages|16.6||||0.0011|TWO_SIDED|95.0|6.0|27.0||One-sided p-value for testing|Miettinen & Nurminem method|Stratified by geographic region (East Asia vs. non-East Asia), ECOG PS (0 vs. 1) and histology (squamous vs. nonsquamous)||H0: difference in %=0 vs. H1: difference in % \>0||27.0|6.0|0.0011
72486838|NCT04490395|144502255|SUPERIORITY||Mean Difference (Final Values)|1.68||||0.044|TWO_SIDED|95.0|-0.26|3.62|||t-test, 2 sided|||||3.62|-0.26|0.044
72486839|NCT04490395|144502256|SUPERIORITY||Mean Difference (Final Values)|0.59||||0.056|TWO_SIDED|95.0|-0.15|1.33|||t-test, 2 sided|||||1.33|-0.15|0.056
72486840|NCT04490395|144502257|SUPERIORITY||Mean Difference (Final Values)|-0.24||||0.377|TWO_SIDED|95.0|-1.75|1.28|||t-test, 2 sided|||||1.28|-1.75|0.377
72486841|NCT04490395|144502258|SUPERIORITY|Within subjects change over time|F test (1,15) df|1.381||||0.258|TWO_SIDED||||||ANOVA|Change over time||Only 9 cases had any data available per group, and some had missing values and were not included in each analysis.|Within subjects change over time.|||0.258
72486842|NCT04490395|144502258|SUPERIORITY|Between group analysis|F test (1,15) df|0.246||||0.627|TWO_SIDED||||||ANOVA||||Between group analysis|||0.627
72486843|NCT04490395|144502258|SUPERIORITY||F test (1,15) df|0.005||||0.947|TWO_SIDED||||||ANOVA|||Time x Condition interaction|Time x Condition interaction|||0.947
72486844|NCT04490395|144502259|SUPERIORITY||Mean Difference (Final Values)|-0.88||||0.038|TWO_SIDED|95.0|-1.85|0.98|||t-test, 2 sided|||||0.98|-1.85|0.038
72486845|NCT04490395|144502260|SUPERIORITY||Mean Difference (Final Values)|-2.56||||0.07|TWO_SIDED|95.0|-6.05|0.94|||t-test, 2 sided|||||0.94|-6.05|0.07
72486846|NCT04490395|144502261|SUPERIORITY||Mean Difference (Final Values)|0.12||||0.43|TWO_SIDED|95.0|-1.19|1.42|||t-test, 2 sided|||||1.42|-1.19|0.43
72486847|NCT04490395|144502262|SUPERIORITY||Mean Difference (Final Values)|-0.029||||0.72|TWO_SIDED|95.0|-0.194|1.42|||t-test, 2 sided|||||1.42|-.194|0.72
72486848|NCT04490395|144502263|SUPERIORITY||Mean Difference (Final Values)|-0.06||||0.341|TWO_SIDED|95.0|-0.35|0.23|||t-test, 2 sided|||||0.23|-0.35|0.341
72486849|NCT04490395|144502264|SUPERIORITY||Mean Difference (Final Values)|-0.059||||0.25|TWO_SIDED|95.0|-2.35|1.17|||t-test, 2 sided|||||1.17|-2.35|0.25
72486850|NCT00857532|144502269|SUPERIORITY_OR_OTHER|||||||0.021||95.0|||||Spearman's Rank Order Correlation|||"P-value for Attention correlation coefficient. Null hypothesis is that there is no correlation between florbetapir SUVR and DRS-2 attention score."||||0.021
72486851|NCT00857532|144502269|SUPERIORITY_OR_OTHER|||||||0.077||95.0|||||Spearman's Rank Order Correlation|||"P-value for Initiation/Perseveration correlation coefficient. Null hypothesis is that there is no correlation between florbetapir SUVR and DRS-2 initiation/perseveration score."||||0.077
72486852|NCT00857532|144502269|SUPERIORITY_OR_OTHER|||||||0.364||95.0|||||Spearman's Rank Order Correlation|||"P-value for Construction correlation coefficient. Null hypothesis is that there is no correlation between florbetapir SUVR and DRS-2 construction score."||||0.364
72486853|NCT00857532|144502269|SUPERIORITY_OR_OTHER|||||||0.266||95.0|||||Spearman's Rank Order Correlation|||"P-value for Conceptualization correlation coefficient. Null hypothesis is that there is no correlation between florbetapir SUVR and DRS-2 conceptualization score."||||0.266
72486854|NCT00857532|144502269|SUPERIORITY_OR_OTHER|||||||0.152||95.0|||||Spearman's Rank Order Correlation|||"P-value for Memory correlation coefficient. Null hypothesis is that there is no correlation between florbetapir SUVR and DRS-2 memory score."||||0.152
72486855|NCT00857532|144502269|SUPERIORITY_OR_OTHER|||||||0.041||95.0|||||Spearman's Rank Order Correlation|||"P-value for DRS-2 Total correlation coefficient. Null hypothesis is that there is no correlation between florbetapir SUVR and DRS-2 total score."||||0.041
72486856|NCT00857532|144502270|SUPERIORITY_OR_OTHER|||||||0.0411||95.0|||||Spearman's Rank Order Correlation|||"P-value for Amyloid beta correlation coefficient. Null hypothesis is that there is no correlation between florbetapir SUVR and amyloid beta."||||0.0411
72486857|NCT00857532|144502270|SUPERIORITY_OR_OTHER|||||||0.58||95.0|||||Spearman's Rank Order Correlation|||"P-value for Tau correlation coefficient. Null hypothesis is that there is no correlation between florbetapir SUVR and tau."||||0.5800
72486858|NCT00857532|144502270|SUPERIORITY_OR_OTHER|||||||0.8164||95.0|||||Spearman's Rank Order Correlation|||"P-value for Phospho-Tau correlation coefficient. Null hypothesis is that there is no correlation between florbetapir SUVR and phospho-tau."||||0.8164
72486859|NCT00257725|144502271|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-1.09|STANDARD_DEVIATION|0.73||0.01|TWO_SIDED|95.0|||||paired t-test|||||||0.01
72486860|NCT00257725|144502272|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-1.64|STANDARD_DEVIATION|1.29||0.01|TWO_SIDED|95.0|||||paired t-test|||||||0.01
72486861|NCT00257725|144502273|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|10.55|STANDARD_DEVIATION|7.7||0.01|TWO_SIDED|95.0|||||paired t-test|||||||0.01
72486862|NCT01858532|144502274|OTHER||||||=|0.029|||||||Stratified log-rank test|||The endpoint was analyzed using the stratified log-rank test for treatment comparison.||||=0.029
72486863|NCT01858532|144502274|OTHER||Hazard Ratio (HR)|0.654|||=|0.005|TWO_SIDED|95.0|0.488|0.878|||Regression, Cox|||A Cox Proportional Hazards regression model with pre-specified covariates adjusted was used to estimate the hazard ratio of atrasentan to placebo and its 95% confidence interval.||0.878|0.488|=0.005
72577018|NCT00261443|144680746|SUPERIORITY_OR_OTHER_LEGACY|||||||0.669||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison, Change from Baseline in QTc (0.33) at Week 52 (LOCF)||||0.669
72577019|NCT00261443|144680746|SUPERIORITY_OR_OTHER_LEGACY|||||||0.072||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Highest Value of Change in QTc (0.33), Phase 3||||0.072
72486864|NCT01858532|144502275|OTHER||||||=|0.289|||||||Stratified log-rank test|||The endpoint was analyzed using the stratified log-rank test for treatment comparison.||||=0.289
72486865|NCT01858532|144502275|OTHER||Hazard Ratio (HR)|0.779||||0.112|TWO_SIDED|95.0|0.573|1.06|||Regression, Cox|||A Cox Proportional Hazards regression model with pre-specified covariates adjusted was used to estimate the hazard ratio of atrasentan to placebo and its 95% confidence interval.||1.060|0.573|0.112
72486866|NCT01858532|144502276|OTHER|||||||0.089|||||||Stratified log-rank test|||The endpoint was analyzed using the stratified log-rank test for treatment comparison.||||0.089
72486867|NCT01858532|144502276|OTHER||Hazard Ratio (HR)|0.801||||0.049|TWO_SIDED|95.0|0.642|0.999|||Regression, Cox|||A Cox Proportional Hazards regression model with pre-specified covariates adjusted was used to estimate the hazard ratio of atrasentan to placebo and its 95% confidence interval.||0.999|0.642|0.049
72486868|NCT01858532|144502277|OTHER||Hazard Ratio (HR)|0.72||||0.002|TWO_SIDED|95.0|0.58|0.89|||Regression, Cox|||A Cox Proportional Hazards regression model with pre-specified covariates adjusted was used to estimate the hazard ratio of atrasentan to placebo and its 95% confidence interval.||0.89|0.58|0.002
72486869|NCT01858532|144502278|OTHER|||||||0.446|||||||Stratified log-rank test|||The endpoint was analyzed using the stratified log-rank test for treatment comparison.||||0.446
72486870|NCT01858532|144502278|OTHER||Hazard Ratio (HR)|0.884||||0.447|TWO_SIDED|95.0|0.643|1.215|||Regression, Cox|||A Cox Proportional Hazards regression model with pre-specified covariates adjusted was used to estimate the hazard ratio of atrasentan to placebo and its 95% confidence interval.||1.215|0.643|0.447
72486871|NCT00514514|144502279|SUPERIORITY_OR_OTHER||Mean Difference (Net)|5.56|||<|0.0001|TWO_SIDED|95.0|2.82|8.31|||ANCOVA|||||8.31|2.82|< 0.0001
72486872|NCT00003895|144502310|SUPERIORITY_OR_OTHER||||||<|0.001||||||Post versus Pre-treatment % g209-2M-specific t-cells|t-test, 2 sided|||||||<.001
72486873|NCT00003895|144502310|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Post versus Pre-Treatment %g209-2M-specific T-cells|t-test, 2 sided|||||||<.0001
72486874|NCT00003895|144502310|SUPERIORITY_OR_OTHER|||||||0.59||||||Arm A Versus Arm B|t-test, 2 sided|||||||0.59
72486875|NCT00806195|144502313|NON_INFERIORITY_OR_EQUIVALENCE|The null hypothesis associated with the safety objective was that the upper limit of the two-sided 95% CI for this difference in the proportion of subjects experiencing at least one severe systemic reaction during the first 7 days after any vaccination (PMenACWY+Routine Vaccines-PRoutine Vaccines) was ≥ 6%.|Mean Difference (Final Values)|3.0|||||TWO_SIDED|95.0|-0.8|6.4|||Miettinen and Nurminen|||MenACWY-CRM 197 administered concomitantly with routine vaccines was considered noninferior to routine vaccines alone with respect to severe systemic reactions if the upper limit of the 2-sided 95% CI of the difference (MenACWY-CRM197 vaccine plus routine vaccines group minus routine vaccines only group) in the proportion of subjects experiencing at least one severe systemic reaction during the first 7 days (days 1-7) after any vaccination was \<6%.||6.4|-0.8|
72486876|NCT00806195|144502314|NON_INFERIORITY_OR_EQUIVALENCE|The null hypothesis associated with the SAE safety objective was that the upper limit of the two-sided 95% confidence interval for the difference between the MenACWY and routine vaccine groups in the proportion of subjects experiencing at least one SAE (PMenACWY + Routine Vaccines - PRoutine Vaccines) was ≥5%.|Mean Difference (Final Values)|0.4|||||TWO_SIDED|95.0|-0.9|1.5|||Miettinen and Nurminen|||MenACWY-CRM 197 administered concomitantly with routine vaccines was considered non inferior to routine vaccines alone with respect to serious adverse events if the upper limit of the 2-sided 95% CI of the difference (MenACWY vaccine plus routine vaccines group minus routine vaccines only group) of the proportion of subjects experiencing at least one serious adverse event was \<5%.||1.5|-0.9|
72486877|NCT00806195|144502314|NON_INFERIORITY_OR_EQUIVALENCE|The null hypothesis associated with the SAE safety objective was that the upper limit of the two-sided 95% confidence interval for the difference between the MenACWY and routine vaccine groups in the proportion of subjects experiencing at least one SAE (PMenACWY + Routine Vaccines - PRoutine Vaccines) was \<5%.|Mean Difference (Final Values)|0.3|||||TWO_SIDED|95.0|-0.8|1.3|||Miettinen and Nurminen|||MenACWY-CRM 197 administered concomitantly with routine vaccines was considered non inferior to routine vaccines alone with respect to serious adverse events if the upper limit of the 2-sided 95% CI of the difference (MenACWY vaccine plus routine vaccines group minus routine vaccines only group) of the proportion of subjects experiencing at least one serious adverse event was \<5%.||1.3|-0.8|
72486878|NCT00139776|144502334|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0||||Threshold for statistical significance p\<0.05|ANOVA|Treatment as fixed effect||"Null hypothesis for primary outcome is that there is no difference in the number of flares observed between the 2 treatment arms of celecoxib 200mg continuous use and celecoxib 200mg intermittent use.~Sample size calculation: Sufficient number of participants were randomized to provide at least 80% power to detect an estimated effect size of 0.2 using a 2-sided t-test at a 0.05 significant level."||||<0.0001
72486879|NCT00139776|144502335|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0||||Threshold for statistical significance p\<0.05|Log Rank|||Kaplan-Meier analysis||||<0.0001
72486880|NCT00139776|144502336|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0||||Threshold for statistical significance p\<0.05|ANOVA|Treatment as fixed effect||||||<0.0001
72486881|NCT00139776|144502337|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0||||Threshold for statistical significance p\<0.05|ANOVA|Treatment as fixed effect||||||<0.0001
72486882|NCT00139776|144502338|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||Threshold for statistical significance p\<0.05|ANCOVA|Treatment as fixed effect and baseline as covariate||Week 4||||<0.001
72486883|NCT00139776|144502338|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||Threshold for statistical significance p\<0.05|ANCOVA|Treatment as fixed effect and baseline as covariate||Week 8||||<0.001
72486884|NCT00139776|144502338|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||Threshold for statistical significance p\<0.05|ANCOVA|Treatment as fixed effect and baseline as covariate||Week 12||||<0.001
72486885|NCT00139776|144502338|SUPERIORITY_OR_OTHER_LEGACY|||||||0.003||95.0||||Threshold for statistical significance p\<0.05|ANCOVA|Treatment as fixed effect and baseline as covariate||Week 16||||0.003
72402841|NCT01480076|144311695|SUPERIORITY_OR_OTHER|||||||0.0091|||||||mixed effect model|||Month 6, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % impairment while working due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0091
72402842|NCT01480076|144311695|SUPERIORITY_OR_OTHER|||||||0.2312|||||||mixed effect model|||Month 6, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % impairment while working due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.2312
72402843|NCT01480076|144311695|SUPERIORITY_OR_OTHER||difference of LS means|-1.8|STANDARD_ERROR_OF_MEAN|5.89||0.7578|TWO_SIDED||||||mixed effect model|||Month 6, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % impairment while working due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.7578
72402844|NCT01480076|144311695|SUPERIORITY_OR_OTHER||difference of LS means|7.9|STANDARD_ERROR_OF_MEAN|13.42||0.5575|TWO_SIDED||||||mixed effect model|||Month 6, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % impairment while working due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.5575
72402845|NCT01480076|144311695|SUPERIORITY_OR_OTHER|||||||0.4486|||||||mixed effect model|||Month 9, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % impairment while working due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.4486
72513917|NCT01968954|144558616|SUPERIORITY_OR_OTHER||LS mean difference|-47.7|STANDARD_ERROR_OF_MEAN|3.16|||TWO_SIDED|95.0|-53.9|-41.5||||||TG \<200 mg/dL (Week 52): LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region.||-41.5|-53.9|
72513918|NCT01968954|144558616|SUPERIORITY_OR_OTHER||LS mean difference|-49.3|STANDARD_ERROR_OF_MEAN|4.83|||TWO_SIDED|95.0|-58.9|-39.8||||||TG \>=200 mg/dL (Week 24): LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region.||-39.8|-58.9|
72513919|NCT01968954|144558616|SUPERIORITY_OR_OTHER||LS mean difference|-41.2|STANDARD_ERROR_OF_MEAN|5.6|||TWO_SIDED|95.0|-52.2|-30.1||||||TG \>=200 mg/dL (Week 52): LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region.||-30.1|-52.2|
72513920|NCT01968954|144558617|SUPERIORITY_OR_OTHER||LS mean difference|-14.2|STANDARD_ERROR_OF_MEAN|2.88|||TWO_SIDED|95.0|-19.9|-8.5||||||Week 12: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region, triglyceride subgroup.||-8.5|-19.9|
72513921|NCT01968954|144558617|SUPERIORITY_OR_OTHER||LS mean difference|-19.9|STANDARD_ERROR_OF_MEAN|2.65|||TWO_SIDED|95.0|-25.1|-14.7||||||Week 24: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region, triglyceride subgroup.||-14.7|-25.1|
72513922|NCT01968954|144558617|SUPERIORITY_OR_OTHER||LS mean difference|-9.2|STANDARD_ERROR_OF_MEAN|3.31|||TWO_SIDED|95.0|-15.7|-2.8||||||Week 52: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region, triglyceride subgroup.||-2.8|-15.7|
72513923|NCT01968954|144558618|SUPERIORITY_OR_OTHER||LS mean difference|3.7|STANDARD_ERROR_OF_MEAN|1.0|||TWO_SIDED|95.0|1.8|5.7||||||Week 12: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region, triglyceride subgroup.||5.7|1.8|
72402846|NCT01480076|144311695|SUPERIORITY_OR_OTHER|||||||0.0102|||||||mixed effect model|||Month 9, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % impairment while working due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0102
72577020|NCT00261443|144680747|SUPERIORITY_OR_OTHER_LEGACY|||||||0.012||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Baseline PR||||0.012
72577021|NCT00261443|144680747|SUPERIORITY_OR_OTHER_LEGACY|||||||0.027||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison, Change from Baseline in PR at Week 52 (LOCF)||||0.027
72577022|NCT00261443|144680747|SUPERIORITY_OR_OTHER_LEGACY|||||||0.128||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Highest Value of Change in PR, Phase 3||||0.128
72577023|NCT00261443|144680748|SUPERIORITY_OR_OTHER_LEGACY|||||||0.571||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Baseline RR||||0.571
72577024|NCT00261443|144680748|SUPERIORITY_OR_OTHER_LEGACY|||||||0.353||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison, Change from Baseline in RR at Week 52 (LOCF)||||0.353
72577025|NCT00261443|144680748|SUPERIORITY_OR_OTHER_LEGACY|||||||0.204||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Highest Value of Change in RR, Phase 3 Safety Sample||||0.204
72486886|NCT00139776|144502338|SUPERIORITY_OR_OTHER_LEGACY|||||||0.022||95.0||||Threshold for statistical significance p\<0.05|ANCOVA|Treatment as fixed effect and baseline as covariate||Week 20||||0.022
72486887|NCT00139776|144502338|SUPERIORITY_OR_OTHER_LEGACY|||||||0.047||95.0||||Threshold for statistical significance p\<0.05|ANCOVA|Treatment as fixed effect and baseline as covariate||Week 24||||0.047
72486888|NCT00139776|144502339|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||Threshold for statistical significance p\<0.05|ANCOVA|Treatment as fixed effect and baseline as covariate||Week 4||||<0.001
72486889|NCT00139776|144502339|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001||95.0||||Threshold for statistical significance p\<0.05|ANCOVA|Treatment as fixed effect and baseline as covariate||Week 8||||0.001
72486890|NCT00139776|144502339|SUPERIORITY_OR_OTHER_LEGACY|||||||0.096||95.0||||Threshold for statistical significance p\<0.05|ANCOVA|Treatment as fixed effect and baseline as covariate||Week 12||||0.096
72486891|NCT00139776|144502339|SUPERIORITY_OR_OTHER_LEGACY|||||||0.338||95.0||||Threshold for statistical significance p\<0.05|ANCOVA|Treatment as fixed effect and baseline as covariate||Week 16||||0.338
72486892|NCT00139776|144502339|SUPERIORITY_OR_OTHER_LEGACY|||||||0.832||95.0||||Threshold for statistical significance p\<0.05|ANCOVA|Treatment as fixed effect and baseline as covariate||Week 20||||0.832
72486893|NCT00139776|144502339|SUPERIORITY_OR_OTHER_LEGACY|||||||0.972||95.0||||Threshold for statistical significance p\<0.05|ANCOVA|Treatment as fixed effect and baseline as covariate||Week 24||||0.972
72513924|NCT01968954|144558618|SUPERIORITY_OR_OTHER||LS mean difference|4.9|STANDARD_ERROR_OF_MEAN|0.91|||TWO_SIDED|95.0|3.1|6.7||||||Week 24: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region, triglyceride subgroup.||6.7|3.1|
72513925|NCT01968954|144558618|SUPERIORITY_OR_OTHER||LS mean difference|2.6|STANDARD_ERROR_OF_MEAN|0.98|||TWO_SIDED|95.0|0.7|4.6||||||Week 52: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region, triglyceride subgroup.||4.6|0.7|
72567918|NCT02037165|144667467|SUPERIORITY_OR_OTHER||adjusted mean difference|-1.04|STANDARD_ERROR_OF_MEAN|2.0282|||TWO_SIDED|95.0|-5.0|2.9|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 24:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||2.9|-5.0|
72486894|NCT00139776|144502340|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0046||95.0||||Overall p-value Threshold for statistical significance p\<0.05|Cochran-Mantel-Haenszel|Test of row mean score differences based on modified ridits (standardizing the mid-rank)||||||0.0046
72486895|NCT00139776|144502341|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0102||95.0||||Threshold for statistical significance p\<0.05|ANOVA|Treatment as fixed effect||||||0.0102
72486896|NCT00139776|144502342|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0012||95.0||||Threshold for statistical significance p\<0.05|ANOVA|Treatment as fixed effect||||||0.0012
72486897|NCT00139776|144502343|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0||||Threshold for statistical significance p\<0.05|ANOVA|Treatment as fixed effect||||||<0.0001
72486898|NCT00139776|144502344|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||Threshold for statistical significance p\<0.05|ANCOVA|Treatment as fixed effect and baseline as covariate||Total WOMAC score||||<0.001
72486899|NCT00139776|144502344|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.6|STANDARD_ERROR_OF_MEAN|0.71||||95.0|0.21|2.99|||||Change in LSmean (score at end of Period III minus score at start of Period III)|Total WOMAC score - Continuous use||2.99|0.21|
72486900|NCT00139776|144502344|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.99|STANDARD_ERROR_OF_MEAN|0.71||||95.0|3.6|6.38|||||Change in LSmean (score at end of Period III minus score at start of Period III)|Total WOMAC score - Intermittent use||6.38|3.60|
72486901|NCT00139776|144502344|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||Threshold for statistical significance p\<0.05|ANCOVA|Treatment as fixed effect and baseline as covariate||WOMAC pain subscale||||<0.001
72513926|NCT01968954|144558619|SUPERIORITY_OR_OTHER||LS mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.93|||TWO_SIDED|95.0|-1.9|1.7||||||Week 12: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region, triglyceride subgroup.||1.7|-1.9|
72486902|NCT00139776|144502344|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.37|STANDARD_ERROR_OF_MEAN|0.15||||95.0|0.06|0.67|||||Change in LSmean (score at end of Period III minus score at start of Period III)|WOMAC pain subscale - Continuous use||0.67|0.06|
72486903|NCT00139776|144502344|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.18|STANDARD_ERROR_OF_MEAN|0.15||||95.0|0.88|1.49|||||Change in LSmean (score at end of Period III minus score at start of Period III)|WOMAC pain subscale - Intermittent use||1.49|0.88|
72486904|NCT00139776|144502344|SUPERIORITY_OR_OTHER_LEGACY|||||||0.004||95.0||||Threshold for statistical significance p\<0.05|ANCOVA|Treatment as fixed effect and baseline as covariate||WOMAC stiffness subscale||||0.004
72486905|NCT00139776|144502344|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.12|STANDARD_ERROR_OF_MEAN|0.07||||95.0|-0.02|0.25|||||Change in LSmean (score at end of Period III minus score at start of Period III)|WOMAC stiffness subscale - Continuous use||0.25|-0.02|
72486906|NCT00139776|144502344|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.4|STANDARD_ERROR_OF_MEAN|0.07||||95.0|0.26|0.53|||||Change in LSmean (score at end of Period III minus score at start of Period III)|WOMAC stiffness subscale - Intermittent use||0.53|0.26|
72486907|NCT00139776|144502344|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002||95.0||||Threshold for statistical significance p\<0.05|ANCOVA|Treatment as fixed effect and baseline as covariate||WOMAC physical function subscale||||0.002
72486908|NCT00139776|144502344|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.13|STANDARD_ERROR_OF_MEAN|0.51||||95.0|0.13|2.14|||||Change in LSmean (score at end of Period III minus score at start of Period III)|WOMAC physical function subscale - Continuous use||2.14|0.13|
72486909|NCT00139776|144502344|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.43|STANDARD_ERROR_OF_MEAN|0.51||||95.0|2.42|4.43|||||Change in LSmean (score at end of Period III minus score at start of Period III)|WOMAC physical function subscale - Intermittent use||4.43|2.42|
72486910|NCT00139776|144502345|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2712||95.0||||Threshold for statistical significance p\<0.05|ANCOVA|Treatment as fixed effect and baseline as covariate||Sleep disturbance||||0.2712
72486911|NCT00139776|144502345|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8737||95.0||||Threshold for statistical significance p\<0.05|ANCOVA|Treatment as fixed effect and baseline as covariate||Snoring||||0.8737
72486912|NCT00139776|144502345|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7703||95.0||||Threshold for statistical significance p\<0.05|ANCOVA|Treatment as fixed effect and baseline as covariate||Awaken short of breath||||0.7703
72486913|NCT00139776|144502345|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3769||95.0||||Threshold for statistical significance p\<0.05|ANCOVA|Treatment as fixed effect and baseline as covariate||Quantity of sleep||||0.3769
72486914|NCT00139776|144502345|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4075||95.0||||Threshold for statistical significance p\<0.05|ANCOVA|Treatment as fixed effect and baseline as covariate||Sleep adequacy||||0.4075
72486915|NCT00139776|144502345|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5854||95.0||||Threshold for statistical significance p\<0.05|ANCOVA|Treatment as fixed effect and baseline as covariate||Somnolence||||0.5854
72486916|NCT00139776|144502345|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8358||95.0||||Threshold for statistical significance p\<0.05|ANCOVA|Treatment as fixed effect and baseline as covariate||Sleep problems index I||||0.8358
72486917|NCT00139776|144502345|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5878||95.0||||Threshold for statistical significance p\<0.05|ANCOVA|Treatment as fixed effect and baseline as covariate||Sleep problems index II||||0.5878
72486918|NCT00139776|144502346|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||Threshold for statistical significance p\<0.05|ANCOVA|Treatment as fixed effect and baseline as covariate||WOMAC total score||||<0.001
72486919|NCT00139776|144502346|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||Threshold for statistical significance p\<0.05|ANCOVA|Treatment as fixed effect and baseline as covariate||WOMAC pain subscale||||<0.001
72486920|NCT00139776|144502346|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||Threshold for statistical significance p\<0.05|ANCOVA|Treatment as fixed effect and baseline as covariate||WOMAC stiffness subscale||||<0.001
72486921|NCT00139776|144502346|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||Threshold for statistical significance p\<0.05|ANCOVA|Treatment as fixed effect and baseline as covariate||WOMAC physical function subscale||||<0.001
72486922|NCT00139776|144502347|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1437||95.0||||Threshold for statistical significance p\<0.05|Cochran-Mantel-Haenszel|by general association||Analysis across all 3 sleep scores for Period III||||0.1437
72486923|NCT00139776|144502348|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0||||Threshold for statistical significance p\<0.05|ANCOVA|Treatment as fixed effect and baseline as covariate||Physical function||||<0.0001
72486924|NCT00139776|144502348|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0||||Threshold for statistical significance p\<0.05|ANCOVA|Treatment as fixed effect and baseline as covariate||Role physical||||<0.0001
72486925|NCT00139776|144502348|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0||||Threshold for statistical significance p\<0.05|ANCOVA|Treatment as fixed effect and baseline as covariate||Bodily pain||||<0.0001
72486926|NCT00139776|144502348|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3097||95.0||||Threshold for statistical significance p\<0.05|ANCOVA|Treatment as fixed effect and baseline as covariate||General health||||0.3097
72486927|NCT00139776|144502348|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0139||95.0||||Threshold for statistical significance p\<0.05|ANCOVA|Treatment as fixed effect and baseline as covariate||Vitality||||0.0139
72486928|NCT00139776|144502348|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1303||95.0||||Threshold for statistical significance p\<0.05|ANCOVA|Treatment as fixed effect and baseline as covariate||Social functioning||||0.1303
72486929|NCT00139776|144502348|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1404||95.0||||Threshold for statistical significance p\<0.05|ANCOVA|Treatment as fixed effect and baseline as covariate||Role emotional||||0.1404
72486930|NCT00139776|144502348|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4015||95.0||||Threshold for statistical significance p\<0.05|ANCOVA|Treatment as fixed effect and baseline as covariate||Mental health||||0.4015
72486931|NCT00139776|144502348|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0||||Threshold for statistical significance p\<0.05|ANCOVA|Treatment as fixed effect and baseline as covariate||Physical component summary||||<0.0001
72486932|NCT00139776|144502348|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0301||95.0||||Threshold for statistical significance p\<0.05|ANCOVA|Treatment as fixed effect and baseline as covariate||Mental component summary||||0.0301
72486933|NCT00674583|144502350|NON_INFERIORITY|Criterion for non-inferiority evaluation: The lower limit (LL) of the two-sided standardized asymptotic 95% CI for the group difference (Nimenrix Group minus Menjugate Group) in the percentages of subjects with vaccine response to rSBA-MenC is greater than or equal to (≥) the pre-defined clinical limit of -10%.|Difference in percentage|-0.88|||||TWO_SIDED|95.0|-5.25|5.75||||||To demonstrate the non-inferiority of the Nimenrix group compared to the Menjugate group, two-sided standardized asymptotic 95% confidence interval (CI) for the groups difference \[Nimenrix group minus Menjugate group\] in the percentages of subjects with bactericidal vaccine response to MenC was computed.||5.75|-5.25|
72486934|NCT02752035|144502368|SUPERIORITY||Hazard Ratio (HR)|0.87||||0.523|TWO_SIDED|95.0|0.57|1.329|||Log Rank||Based on Cox proportional hazards model.|Stratification factors were age group per IRT, risk groups and baseline FLT3 mutation status, with potential of strata pooling.||1.329|0.570|0.523
72486935|NCT02752035|144502369|SUPERIORITY||Hazard Ratio (HR)|0.94||||0.787|TWO_SIDED|95.0|0.635|1.393|||Log Rank||Based on Cox proportional hazards model.|Stratification factors were age group per IRT, risk groups and baseline FLT3 mutation status, with potential of strata pooling.||1.393|0.635|0.787
72486936|NCT02752035|144502371|SUPERIORITY||Treatment Difference|8.2||||0.249|TWO_SIDED|95.0|-6.5|23.0||Based on stratified Cochran-Mantel-Haenszel test. Stratification factor was age group per interactive response technology.|Cochran-Mantel-Haenszel|||||23.0|-6.5|0.249
72486937|NCT02752035|144502372|SUPERIORITY||Treatment Difference|33.3|||<|0.001|TWO_SIDED|95.0|16.6|50.0||Based on stratified Cochran-Mantel-Haenszel test. Stratification factor was age group per interactive response technology.|Cochran-Mantel-Haenszel|||||50.0|16.6|<0.001
72567919|NCT02037165|144667468|SUPERIORITY_OR_OTHER||adjusted mean difference|-0.94|STANDARD_ERROR_OF_MEAN|1.8566|||TWO_SIDED|95.0|-4.6|2.7|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 0:30h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||2.7|-4.6|
72567920|NCT02037165|144667468|SUPERIORITY_OR_OTHER||adjusted mean difference|-2.87|STANDARD_ERROR_OF_MEAN|1.856|||TWO_SIDED|95.0|-6.5|0.8|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 1:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||0.8|-6.5|
72567921|NCT02037165|144667468|SUPERIORITY_OR_OTHER||adjusted mean difference|-3.08|STANDARD_ERROR_OF_MEAN|1.8557|||TWO_SIDED|95.0|-6.7|0.6|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 2:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||0.6|-6.7|
72567922|NCT02037165|144667468|SUPERIORITY_OR_OTHER||adjusted mean difference|-1.63|STANDARD_ERROR_OF_MEAN|1.8555|||TWO_SIDED|95.0|-5.3|2.0|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 3:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||2.0|-5.3|
72567923|NCT02037165|144667468|SUPERIORITY_OR_OTHER||adjusted mean difference|0.11|STANDARD_ERROR_OF_MEAN|1.8554|||TWO_SIDED|95.0|-3.5|3.8|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 4:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||3.8|-3.5|
72567924|NCT02037165|144667468|SUPERIORITY_OR_OTHER||adjusted mean difference|0.66|STANDARD_ERROR_OF_MEAN|1.8555|||TWO_SIDED|95.0|-3.0|4.3|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 5:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||4.3|-3.0|
72567925|NCT02037165|144667468|SUPERIORITY_OR_OTHER||adjusted mean difference|-1.19|STANDARD_ERROR_OF_MEAN|1.8557|||TWO_SIDED|95.0|-4.8|2.5|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 6:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||2.5|-4.8|
72567926|NCT02037165|144667468|SUPERIORITY_OR_OTHER||adjusted mean difference|-1.34|STANDARD_ERROR_OF_MEAN|1.856|||TWO_SIDED|95.0|-5.0|2.3|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 22:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||2.3|-5.0|
72577026|NCT00261443|144680748|SUPERIORITY_OR_OTHER_LEGACY|||||||0.435||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Lowest Value of Change in Prolactin, Phase 3 Safety Sample||||0.435
72402847|NCT01480076|144311695|SUPERIORITY_OR_OTHER|||||||0.1185|||||||mixed effect model|||Month 9, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % impairment while working due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.1185
72486938|NCT02752035|144502373|SUPERIORITY||Treatment Difference|8.5||||0.049|TWO_SIDED|95.0|-0.1|17.1||Based on stratified Cochran-Mantel-Haenszel test. Stratification factor was age group per interactive response technology.|Cochran-Mantel-Haenszel|||||17.1|-0.1|0.049
72486939|NCT02752035|144502374|SUPERIORITY||Treatment Difference|16.7||||0.032|TWO_SIDED|95.0|1.1|32.4||Based on stratified Cochran-Mantel-Haenszel test. Stratification factor was age group per interactive response technology.|Cochran-Mantel-Haenszel|||||32.4|1.1|0.032
72513927|NCT01968954|144558619|SUPERIORITY_OR_OTHER||LS mean difference|1.9|STANDARD_ERROR_OF_MEAN|1.02|||TWO_SIDED|95.0|-0.1|3.9||||||Week 24: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region, triglyceride subgroup.||3.9|-0.1|
72486940|NCT02752035|144502375|SUPERIORITY||Treatment Difference|-9.0||||0.34|TWO_SIDED|95.0|-29.8|11.0||Based on stratified Cochran-Mantel-Haenszel test. Stratification factor was age group per interactive response technology.|Cochran-Mantel-Haenszel|||||11.0|-29.8|0.340
72486941|NCT02752035|144502376|SUPERIORITY||Treatment Difference|50.0||||0.221|TWO_SIDED|95.0|-61.0|100.0||Based on stratified Cochran-Mantel-Haenszel test. Stratification factor was age group per interactive response technology.|Cochran-Mantel-Haenszel|||||100.0|-61.0|0.221
72486942|NCT02752035|144502377|SUPERIORITY||Hazard Ratio (HR)|0.844||||0.592|TWO_SIDED|95.0|0.451|1.58|||Log Rank||Based on Cox proportional hazards model adjusting age group per IRT.|||1.580|0.451|0.592
72486943|NCT02752035|144502378|SUPERIORITY||Hazard Ratio (HR)|0.573||||0.3|TWO_SIDED|95.0|0.198|1.658|||Log Rank||Based on Cox proportional hazards model adjusting age group per IRT.|Analysis reported for duration of CR/CRh.||1.658|0.198|0.300
72486944|NCT02752035|144502378|SUPERIORITY||Hazard Ratio (HR)|0.411||||0.171|TWO_SIDED|95.0|0.113|1.504|||Log Rank||Based on Cox proportional hazards model adjusting age group per IRT.|Analysis reported for duration of CR.||1.504|0.113|0.171
72486945|NCT02752035|144502378|SUPERIORITY||Hazard Ratio (HR)|0.691||||0.383|TWO_SIDED|95.0|0.295|1.62|||Log Rank||Based on Cox proportional hazards model adjusting age group per IRT.|Analysis reported for duration of CRc||1.620|0.295|0.383
72486946|NCT02752035|144502378|SUPERIORITY||Hazard Ratio (HR)|999.0||||0.998|TWO_SIDED|95.0|0.001||Upper limit of 95% confidence interval was not estimable due to insufficient number of participants.||Log Rank||Based on Cox proportional hazards model adjusting age group per IRT.|Analysis reported for duration of CRh.|||0.001|0.998
72486947|NCT02752035|144502378|SUPERIORITY||Hazard Ratio (HR)|0.628||||0.174|TWO_SIDED|95.0|0.321|1.229|||Log Rank||Based on Cox proportional hazards model adjusting age group per IRT.|Analysis reported for duration of response.||1.229|0.321|0.174
72486948|NCT02752035|144502379|SUPERIORITY||Least square mean difference|0.5||||0.56|TWO_SIDED|95.0|-1.1|2.0|||ANCOVA|Using analysis of covariance including treatment, age group per IRT and baseline score as covariate.|Least square mean difference and P-value were calculated using AZA as reference.|||2.0|-1.1|0.560
72486949|NCT03861936|144502394|SUPERIORITY||Percentage Difference|68.8|||<|0.0001|TWO_SIDED|95.0|54.5|83.1||P-values for between-treatment comparisons are based on Cochran-Mantel-Haenszel (CMH) model stratified by baseline MMPS Grade (4 or 5).|Cochran-Mantel-Haenszel|||||83.1|54.5|<.0001
72486950|NCT03861936|144502394|SUPERIORITY||Percentage Difference|69.6|||<|0.0001|TWO_SIDED|95.0|55.1|84.0||P-values for between-treatment comparisons are based on CMH model stratified by baseline MMPS Grade (4 or 5).|Cochran-Mantel-Haenszel|||||84.0|55.1|<.0001
72486951|NCT03861936|144502400|SUPERIORITY||Percentage Difference|48.4|||<|0.0001|TWO_SIDED|95.0|33.1|63.7||P-values for between-treatment comparisons are based on CMH model stratified by baseline MMPS Grade (4 or 5).|Cochran-Mantel-Haenszel|||||63.7|33.1|<.0001
72486952|NCT03861936|144502400|SUPERIORITY||Percentage Difference|45.7|||<|0.0001|TWO_SIDED|95.0|29.5|61.8||P-values for between-treatment comparisons are based on CMH model stratified by baseline MMPS Grade (4 or 5).|Cochran-Mantel-Haenszel|||||61.8|29.5|<.0001
72486953|NCT03861936|144502401|SUPERIORITY||Percentage Difference|55.2|||<|0.0001|TWO_SIDED|95.0|39.6|70.8||P-values for between-treatment comparisons are based on CMH model stratified by baseline MMPS Grade (4 or 5).|Cochran-Mantel-Haenszel|||||70.8|39.6|<.0001
72486954|NCT03861936|144502401|SUPERIORITY||Percentage Difference|60.9|||<|0.0001|TWO_SIDED|95.0|45.1|76.7||P-values for between-treatment comparisons are based on CMH model stratified by baseline MMPS Grade (4 or 5).|Cochran-Mantel-Haenszel|||||76.7|45.1|<.0001
72486955|NCT03861936|144502402|SUPERIORITY||Percentage Difference|54.2|||<|0.0001|TWO_SIDED|95.0|37.9|70.5||P-values for between-treatment comparisons are based on CMH model stratified by baseline MMPS Grade (4 or 5).|Cochran-Mantel-Haenszel|||||70.5|37.9|<.0001
72486956|NCT03861936|144502402|SUPERIORITY||Percentage Difference|47.8|||<|0.0001|TWO_SIDED|95.0|30.1|65.6||P-values for between-treatment comparisons are based on CMH model stratified by baseline MMPS Grade (4 or 5).|Cochran-Mantel-Haenszel|||||65.6|30.1|<.0001
72486957|NCT03861936|144502403|SUPERIORITY||Percentage Difference|68.8|||<|0.0001|TWO_SIDED|95.0|54.5|83.1||P-values for between-treatment comparisons are based on CMH model stratified by baseline MMPS Grade (4 or 5).|Cochran-Mantel-Haenszel|||||83.1|54.5|<.0001
72486958|NCT03861936|144502403|SUPERIORITY||Percentage Difference|52.2|||<|0.0001|TWO_SIDED|95.0|34.8|69.6||P-values for between-treatment comparisons are based on CMH model stratified by baseline MMPS Grade (4 or 5).|Cochran-Mantel-Haenszel|||||69.6|34.8|<.0001
72486959|NCT03861936|144502404|SUPERIORITY||Least Squares (LS) Mean Difference|-5.82|STANDARD_ERROR_OF_MEAN|0.647|<|0.0001|TWO_SIDED|95.0|-7.1|-4.54||The change from baseline was analyzed using ANCOVA with study intervention and investigator site as factors and baseline MMPS Grade as a covariate.|ANCOVA|||||-4.54|-7.10|<.0001
72486960|NCT03861936|144502404|SUPERIORITY||LS Mean Difference|-5.81|STANDARD_ERROR_OF_MEAN|0.678|<|0.0001|TWO_SIDED|95.0|-7.15|-4.47||The change from baseline was analyzed using ANCOVA with study intervention and investigator site as factors and baseline MMPS Grade as a covariate.|ANCOVA|||||-4.47|-7.15|<.0001
72486961|NCT03861936|144502405|SUPERIORITY||LS Mean Difference|-7.63|STANDARD_ERROR_OF_MEAN|0.756|<|0.0001|TWO_SIDED|95.0|-9.12|-6.13||The change from baseline was analyzed using ANCOVA with study intervention and investigator site as factors and baseline MMPS Grade as a covariate.|ANCOVA|||||-6.13|-9.12|<.0001
72486962|NCT03861936|144502405|SUPERIORITY||LS Mean Difference|-8.26|STANDARD_ERROR_OF_MEAN|0.793|<|0.0001|TWO_SIDED|95.0|-9.83|-6.69||The change from baseline was analyzed using ANCOVA with study intervention and investigator site as factors and baseline MMPS Grade as a covariate.|ANCOVA|||||-6.69|-9.83|<.0001
72486963|NCT01846728|144502415|OTHER|||||||0.84||||||Because this was a pilot study, the study was not powered to detect differences over time. the study was performed to generate preliminary data on means and standard deviations|t-test, 2 sided|||||||0.84
72402848|NCT01480076|144311695|SUPERIORITY_OR_OTHER|||||||0.7523|||||||mixed effect model|||Month 9, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % impairment while working due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.7523
72402849|NCT01480076|144311695|SUPERIORITY_OR_OTHER||difference of LS means|17.1|STANDARD_ERROR_OF_MEAN|7.38||0.0214|TWO_SIDED||||||mixed effect model|||Month 9, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % impairment while working due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0214
72402850|NCT01480076|144311695|SUPERIORITY_OR_OTHER||difference of LS means|0.4|STANDARD_ERROR_OF_MEAN|19.12||0.9826|TWO_SIDED||||||mixed effect model|||Month 9, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % impairment while working due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.9826
72402851|NCT01480076|144311695|SUPERIORITY_OR_OTHER|||||||0.6627|||||||mixed effect model|||Month 12, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % impairment while working due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.6627
72513928|NCT01968954|144558619|SUPERIORITY_OR_OTHER||LS mean difference|1.0|STANDARD_ERROR_OF_MEAN|1.03|||TWO_SIDED|95.0|-1.0|3.1||||||Week 52: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region, triglyceride subgroup.||3.1|-1.0|
72513929|NCT01968954|144558620|SUPERIORITY_OR_OTHER||LS-Mean Difference|-14.2|STANDARD_ERROR_OF_MEAN|2.88|||TWO_SIDED|95.0|-19.9|-8.5||||||Week 12: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region, triglyceride subgroup.||-8.5|-19.9|
72513930|NCT01968954|144558620|SUPERIORITY_OR_OTHER||LS mean difference|-19.9|STANDARD_ERROR_OF_MEAN|2.65|||TWO_SIDED|95.0|-25.1|-14.7||||||Week 24: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region, triglyceride subgroup.||-14.7|-25.1|
72513931|NCT01968954|144558620|SUPERIORITY_OR_OTHER||LS mean difference|-9.2|STANDARD_ERROR_OF_MEAN|3.31|||TWO_SIDED|95.0|-15.7|-2.8||||||Week 52: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region, triglyceride subgroup.||-2.8|-15.7|
72513932|NCT01968954|144558621|SUPERIORITY_OR_OTHER||LS mean difference|-64.2|STANDARD_ERROR_OF_MEAN|2.51|||TWO_SIDED|95.0|-69.1|-59.2||||||TG \<200 mg/dL (Week 12): LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region.||-59.2|-69.1|
72513933|NCT01968954|144558621|SUPERIORITY_OR_OTHER||LS mean difference|-59.6|STANDARD_ERROR_OF_MEAN|5.99|||TWO_SIDED|95.0|-71.4|-47.7||||||TG \>=200 mg/dL (Week 12): LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region.||-47.7|-71.4|
72513934|NCT01968954|144558622|SUPERIORITY_OR_OTHER||LS mean difference|-63.4|STANDARD_ERROR_OF_MEAN|2.35|||TWO_SIDED|95.0|-68.0|-58.8||||||Week 12: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region, triglyceride subgroup.||-58.8|-68.0|
72513935|NCT01968954|144558623|SUPERIORITY_OR_OTHER||LS mean difference|-67.1|STANDARD_ERROR_OF_MEAN|2.59|||TWO_SIDED|95.0|-72.2|-62.1||||||Week 12: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region, triglyceride subgroup.||-62.1|-72.2|
72513936|NCT01968954|144558624|SUPERIORITY_OR_OTHER||LS mean difference|-69.7|STANDARD_ERROR_OF_MEAN|2.57|||TWO_SIDED|95.0|-74.7|-64.6||||||Week 12: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region, triglyceride subgroup.||-64.6|-74.7|
72513937|NCT01968954|144558625|SUPERIORITY_OR_OTHER||LS mean difference|-47.3|STANDARD_ERROR_OF_MEAN|1.74|||TWO_SIDED|95.0|-50.7|-43.8||||||Week 12: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region, triglyceride subgroup.||-43.8|-50.7|
72577027|NCT00261443|144680749|SUPERIORITY_OR_OTHER_LEGACY|||||||0.826||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Baseline QRS||||0.826
72402852|NCT01480076|144311695|SUPERIORITY_OR_OTHER|||||||0.4674|||||||mixed effect model|||Month 12, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % impairment while working due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.4674
72513938|NCT01968954|144558626|SUPERIORITY_OR_OTHER||LS mean difference|-10.6|STANDARD_ERROR_OF_MEAN|1.17|||TWO_SIDED|95.0|-12.9|-8.3||||||Week 12: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region, triglyceride subgroup.||-8.3|-12.9|
72577028|NCT00261443|144680749|SUPERIORITY_OR_OTHER_LEGACY|||||||0.545||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison, Change from Baseline in QRS at Week 52 (LOCF)||||0.545
72513939|NCT01968954|144558627|SUPERIORITY_OR_OTHER||LS mean difference|2.4|STANDARD_ERROR_OF_MEAN|0.55|||TWO_SIDED|95.0|1.4|3.5||||||Week 12: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region, triglyceride subgroup.||3.5|1.4|
72513940|NCT01968954|144558628|SUPERIORITY_OR_OTHER||LS mean difference|-1.6|STANDARD_ERROR_OF_MEAN|0.06|||TWO_SIDED|95.0|-1.7|-1.4||||||Week 12: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region, triglyceride subgroup.||-1.4|-1.7|
72513941|NCT01968954|144558628|SUPERIORITY_OR_OTHER||LS mean difference|-1.5|STANDARD_ERROR_OF_MEAN|0.08|||TWO_SIDED|95.0|-1.7|-1.4||||||Week 24: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region, triglyceride subgroup.||-1.4|-1.7|
72513942|NCT01968954|144558628|SUPERIORITY_OR_OTHER||LS mean difference|-1.2|STANDARD_ERROR_OF_MEAN|0.08|||TWO_SIDED|95.0|-1.4|-1.0||||||Week 52: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region, triglyceride subgroup.||-1.0|-1.4|
72513943|NCT01968954|144558629|SUPERIORITY_OR_OTHER||LS mean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.01|||TWO_SIDED|95.0|-0.4|-0.3||||||Week 12: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region, triglyceride subgroup.||-0.3|-0.4|
72513944|NCT01968954|144558629|SUPERIORITY_OR_OTHER||LS mean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.01|||TWO_SIDED|95.0|-0.4|-0.3||||||Week 24: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region, triglyceride subgroup.||-0.3|-0.4|
72513945|NCT01968954|144558629|SUPERIORITY_OR_OTHER||LS mean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.02|||TWO_SIDED|95.0|-0.3|-0.2||||||Week 52: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region, triglyceride subgroup.||-0.2|-0.3|
72513946|NCT01968954|144558630|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|24.0|||||TWO_SIDED|95.0|13.86|41.64||||||Week 12||41.64|13.86|
72513947|NCT01968954|144558630|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|14.8|||||TWO_SIDED|95.0|9.32|23.56||||||Week 24||23.56|9.32|
72513948|NCT01968954|144558630|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|9.8|||||TWO_SIDED|95.0|6.36|15.24||||||Week 52||15.24|6.36|
72513949|NCT01968954|144558631|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|95.2|||||TWO_SIDED|95.0|52.09|173.91||||||Week 12||173.91|52.09|
72513950|NCT01968954|144558631|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|112.2|||||TWO_SIDED|95.0|55.81|225.52||||||Week 24||225.52|55.81|
72577029|NCT00261443|144680749|SUPERIORITY_OR_OTHER_LEGACY|||||||0.372||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Highest Value of Change in QRS, Phase 3||||0.372
72513951|NCT01968954|144558631|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|29.1|||||TWO_SIDED|95.0|17.13|49.49||||||Week 52||49.49|17.13|
72513952|NCT00751114|144558638|SUPERIORITY_OR_OTHER||adjusted mean difference|-0.59|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001|TWO_SIDED|95.0|-0.77|-0.42||An analysis of covariance (ANCOVA) was performed, with the HbA1c change from baseline to last on-treatment measurement as dependent variable, treatment as fixed effect and the corresponding baseline HbA1c value as covariate|ANCOVA||Difference (Insulin glargine - Sitagliptin)|"H0: no difference between insulin glargine mean HbA1c change and sitagliptin mean HbA1c change~H1: difference between insulin glargine mean HbA1c change and sitagliptin mean HbA1c change~Assuming:~* Estimated standard deviation of the change in HbA1c of 1.3%~* Expected mean difference to be detected of 0.4%~* Alpha risk of 5% (two-sided)~* Power of 90%~* Equal sample size in each treatment group (1:1 randomization)~A total number of 446 evaluable patients (223 in each group) was required"||-0.42|-0.77|<0.0001
72513953|NCT04465396|144558662|EQUIVALENCE|Equivalence between pen injector and syringe injection was to be considered established if the 90% confidence interval (CI) of the corresponding geometric mean ratio was within the acceptance interval of 80.00% to 125.00%.|Geometric Mean Ratio|109.22|||||TWO_SIDED|90.0|104.83|113.8|||||The analysis was performed using Proc Mixed in statistical software suite (SAS), with treatment, sequence, period, and participant within sequence as fixed effects.|||113.80|104.83|
72513954|NCT04465396|144558662|EQUIVALENCE|Equivalence between pen injector and syringe injection was to be considered established if the 90% CI of the corresponding geometric mean ratio was within the acceptance interval of 80.00% to 125.00%.|Geometric Mean Ratio|113.99|||||TWO_SIDED|90.0|108.32|119.95|||||The analysis was performed using Proc Mixed in SAS, with treatment, sequence, period, and participant within sequence as fixed effects.|||119.95|108.32|
72513955|NCT04465396|144558663|EQUIVALENCE|Equivalence between pen injector and syringe injection was to be considered established if the 90% CI of the corresponding geometric mean ratio was within the acceptance interval of 80.00% to 125.00%.|Geometric Mean Ratio|98.27|||||TWO_SIDED|90.0|88.5|109.11|||||The analysis was performed using Proc Mixed in SAS, with treatment, sequence, period, and participant within sequence as fixed effects.|||109.11|88.50|
72513956|NCT04465396|144558663|EQUIVALENCE|Equivalence between pen injector and syringe injection was to be considered established if the 90% CI of the corresponding geometric mean ratio was within the acceptance interval of 80.00% to 125.00%.|Geometric Mean Ratio|92.48|||||TWO_SIDED|90.0|83.8|102.05|||||The analysis was performed using Proc Mixed in SAS, with treatment, sequence, period, and participant within sequence as fixed effects.|||102.05|83.80|
72513957|NCT04465396|144558664|EQUIVALENCE|Equivalence between pen injector and syringe injection was to be considered established if the 90% CI of the corresponding geometric mean ratio was within the acceptance interval of 80.00% to 125.00%.|Geometric Mean Ratio|109.44|||||TWO_SIDED|90.0|105.51|113.51|||||The analysis was performed using Proc Mixed in SAS, with treatment, sequence, period, and participant within sequence as fixed effects.|||113.51|105.51|
72513958|NCT04465396|144558664|EQUIVALENCE|Equivalence between pen injector and syringe injection was to be considered established if the 90% CI of the corresponding geometric mean ratio was within the acceptance interval of 80.00% to 125.00%.|Geometric Mean Ratio|118.4|||||TWO_SIDED|90.0|112.31|124.83|||||The analysis was performed using Proc Mixed in SAS, with treatment, sequence, period, and participant within sequence as fixed effects.|||124.83|112.31|
72513959|NCT00547638|144558697|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence is demonstrated if the upper limit of the 95% confidence interval (when subtracting the percentage of DERMABOND PROTAPE successful subjects from the percentage of DERMABOND HVD successful subjects) does not exceed 8%.|Difference in Proportion of Successes|-7.9|||||TWO_SIDED|95.0|-17.7|1.0|||Gart-Nam||The value for the Estimated Parameter is expressed as a percentage and is defined as the difference in the proportion of sucesses between study groups.|||1.0|-17.7|
72513960|NCT00547638|144558698|SUPERIORITY_OR_OTHER|||||||0.457||||||The total mHCS scores are summarized as proportion of subjects with good outcome (total scores of zero) and a comparison of treatment groups by Fisher Exact Test was performed to confirm differences in groups.|Fisher Exact|||||||0.457
72513961|NCT00547638|144558699|SUPERIORITY_OR_OTHER|||||||1||95.0||||Differences between treatment groups in the incidence rate of infection at Day 14 and Day 30 were compared using the Fisher's Exact Test.|Fisher Exact|||||||1.0000
72486964|NCT01846728|144502416|OTHER|||||||0.66|||||||t-test, 2 sided|||Because this was a pilot study, the study was not powered to detect differences over time. the study was performed to generate preliminary data on means and standard deviations||||0.66
72486965|NCT01846728|144502417|OTHER|Because this was a pilot study, the study was not powered to detect differences over time. the study was performed to generate preliminary data on means and standard deviations||||||0.92|||||||t-test, 2 sided|||||||0.92
72486966|NCT01846728|144502418|OTHER|||||||0.98|||||||t-test, 2 sided|||Because this was a pilot study, the study was not powered to detect differences over time. the study was performed to generate preliminary data on means and standard deviations||||0.98
72486967|NCT01846728|144502419|OTHER|||||||0.66|||||||t-test, 2 sided|||Because this was a pilot study, the study was not powered to detect differences over time. the study was performed to generate preliminary data on means and standard deviations||||0.66
72486968|NCT02161575|144502420|SUPERIORITY||Median Difference (Final Values)|-30.75|||<|0.0001|TWO_SIDED|95.0|-59.5|-20.5|||Wilcoxon (Mann-Whitney)|Confidence Interval for the Median Change form Baseline||The null hypothesis was that the change in CSRT from baseline to Day 90 was zero||-20.50|-59.50|<0.0001
72486969|NCT02446314|144502453|SUPERIORITY||||||=|0.04|||||||Linear Mixed Model / Baseline Covariate|||||||= .04
72486970|NCT02446314|144502454|SUPERIORITY||||||>|0.05|||||||Linear Mixed Model / Baseline Covariate|||||||> .05
72486971|NCT02446314|144502455|SUPERIORITY||||||>|0.05|||||||Linear Mixed Model / Baseline Covariate|||||||> .05
72486972|NCT02446314|144502456|SUPERIORITY||||||>|0.05|||||||Linear Mixed Model / Baseline Covariate|||||||> .05
72486973|NCT02446314|144502457|SUPERIORITY||||||>|0.05|||||||Linear Mixed Model / Baseline Covariate|||||||> .05
72486974|NCT00701090|144502469|NON_INFERIORITY_OR_EQUIVALENCE|The pre-specified non-inferiority margin was 0.4%, i.e., Sitagliptin was declared non-inferior to glimepiride if the upper limit of the two-sided 95% confidence interval for the between group difference (sitagliptin minus glimepiride) was less than 0.4%|Mean Difference (Net)|0.07|STANDARD_DEVIATION|0.7|||TWO_SIDED|95.0|-0.03|0.16|||||ANCOVA model with terms: treatment, country, and baseline HbA1c.|||0.16|-0.03|
72486975|NCT00701090|144502470|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.9|STANDARD_DEVIATION|28.8|||TWO_SIDED|95.0|-0.9|6.7|||||ANCOVA model terms: treatment, country, and baseline.|||6.7|-0.9|
72486976|NCT00701090|144502471|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-15.0|||<|0.001|TWO_SIDED|95.0|-19.3|-10.9|||Miettinen &Nurminen method||Miettinen \&Nurminen method was used for the 95% confidence interval|||-10.9|-19.3|<0.001
72486977|NCT00701090|144502472|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.0|STANDARD_DEVIATION|2.9|<|0.001|TWO_SIDED|95.0|-2.3|-1.6|||ANCOVA|Model terms: treatment, country, and baseline.|ANCOVA model terms: treatment, country, and baseline.|||-1.6|-2.3|<0.001
72486978|NCT00701090|144502473|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.65|||||TWO_SIDED|95.0|0.47|0.9|||||The parameter estimate and 95% CI represent the odds of having A1C \<7.0% at Week 30 in the Sitagliptin group vs. the Glimepiride group, computed using a logistic regression model controlling for treatment, country and baseline A1C.|||0.90|0.47|
72486979|NCT00701090|144502474|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.67|||||TWO_SIDED|95.0|0.47|0.95|||||The parameter estimate and 95% CI represent the odds of having A1C \<6.5% at Week 30 in the Sitagliptin group vs. the Glimepiride group, computed using a logistic regression model controlling for treatment, country and baseline A1C.|||0.95|0.47|
72486980|NCT00324753|144502475|SUPERIORITY|||||||0.005||||||p-value based on a test of any treatment difference by site.|Mixed Models Analysis|The model was run using the xtlogit command in Stata and was adjusted for all of the reported baseline characteristics.||||||.005
72486981|NCT03962738|144502513|SUPERIORITY||Odds Ratio (OR)|3.46|||<|0.001|TWO_SIDED|95.0|2.17|5.54|||Regression, Logistic|||||5.54|2.17|<0.001
72486982|NCT03962738|144502514|SUPERIORITY||||||<|0.001|||||||Cochran-Armitage Trend Test|||||||<.001
72486983|NCT03962738|144502515|SUPERIORITY||Odds Ratio (OR)|1.76||||0.037|TWO_SIDED|95.0|1.03|2.99|||Regression, Logistic|||||2.99|1.03|0.037
72486984|NCT03962738|144502515|SUPERIORITY||Odds Ratio (OR)|3.34|||<|0.001|TWO_SIDED|95.0|2.16|5.17|||Regression, Logistic|||||5.17|2.16|<0.001
72486985|NCT03962738|144502515|SUPERIORITY||Odds Ratio (OR)|2.95|||<|0.001|TWO_SIDED|95.0|1.89|4.62|||Regression, Logistic|||||4.62|1.89|<0.001
72486986|NCT03962738|144502516|SUPERIORITY||Odds Ratio (OR)|1.49||||0.197|TWO_SIDED|95.0|0.81|2.72|||Regression, Logistic|||||2.72|0.81|0.197
72486987|NCT03962738|144502516|SUPERIORITY||Odds Ratio (OR)|1.59||||0.044|TWO_SIDED|95.0|1.01|2.5|||Regression, Logistic|||||2.50|1.01|0.044
72486988|NCT03962738|144502516|SUPERIORITY||Odds Ratio (OR)|1.75||||0.023|TWO_SIDED|95.0|1.08|2.83|||Regression, Logistic|||||2.83|1.08|0.023
72486989|NCT03962738|144502517|SUPERIORITY||Odds Ratio (OR)|1.52||||0.268|TWO_SIDED|95.0|0.73|3.17|||Regression, Logistic|||||3.17|0.73|0.268
72486990|NCT03962738|144502517|SUPERIORITY||Odds Ratio (OR)|2.19||||0.006|TWO_SIDED|95.0|1.26|3.82|||Regression, Logistic|||||3.82|1.26|0.006
72486991|NCT03962738|144502517|SUPERIORITY||Odds Ratio (OR)|2.63|||<|0.001|TWO_SIDED|95.0|1.5|4.61|||Regression, Logistic|||||4.61|1.50|<0.001
72486992|NCT03962738|144502518|SUPERIORITY||Odds Ratio (OR)|1.26||||0.535|TWO_SIDED|95.0|0.61|2.58|||Regression, Logistic|||||2.58|0.61|0.535
72486993|NCT03962738|144502518|SUPERIORITY||Odds Ratio (OR)|1.77||||0.036|TWO_SIDED|95.0|1.04|3.03|||Regression, Logistic|||||3.03|1.04|0.036
72513962|NCT00547638|144558699|SUPERIORITY_OR_OTHER|||||||1||95.0||||Differences between treatment groups in the incidence rate of infection at Day 30 were compared using the Fisher's Exact Test.|Fisher Exact|||||||1.0000
72486994|NCT03962738|144502518|SUPERIORITY||Odds Ratio (OR)|1.93||||0.018|TWO_SIDED|95.0|1.12|3.33|||Regression, Logistic|||||3.33|1.12|0.018
72513963|NCT00547638|144558700|SUPERIORITY_OR_OTHER|||||||0.188||95.0||||Intent to treat population was analyzed.|Fisher Exact|||||||0.188
72486995|NCT03962738|144502519|SUPERIORITY||Odds Ratio (OR)|1.67||||0.199|TWO_SIDED|95.0|0.76|3.65|||Regression, Logistic|||||3.65|0.76|0.199
72486996|NCT03962738|144502519|SUPERIORITY||Odds Ratio (OR)|1.33||||0.305|TWO_SIDED|95.0|0.77|2.32|||Regression, Logistic|||||2.32|0.77|0.305
72486997|NCT03962738|144502519|SUPERIORITY||Odds Ratio (OR)|1.26||||0.426|TWO_SIDED|95.0|0.71|2.24|||Regression, Logistic|||||2.24|0.71|0.426
72486998|NCT03962738|144502520|SUPERIORITY||Odds Ratio (OR)|1.57||||0.135|TWO_SIDED|95.0|0.87|2.82|||Regression, Logistic|||||2.82|0.87|0.135
72486999|NCT03962738|144502520|SUPERIORITY||Odds Ratio (OR)|1.48||||0.08|TWO_SIDED|95.0|0.95|2.3|||Regression, Logistic|||||2.30|0.95|0.080
72487000|NCT03962738|144502520|SUPERIORITY||Odds Ratio (OR)|1.56||||0.061|TWO_SIDED|95.0|0.98|2.49|||Regression, Logistic|||||2.49|0.98|0.061
72487001|NCT03962738|144502521|SUPERIORITY||Odds Ratio (OR)|1.38||||0.342|TWO_SIDED|95.0|0.71|2.67|||Regression, Logistic|||||2.67|0.71|0.342
72487002|NCT03962738|144502521|SUPERIORITY||Odds Ratio (OR)|1.25||||0.377|TWO_SIDED|95.0|0.76|2.04|||Regression, Logistic|||||2.04|0.76|0.377
72487003|NCT03962738|144502521|SUPERIORITY||Odds Ratio (OR)|1.05||||0.862|TWO_SIDED|95.0|0.63|1.72|||Regression, Logistic|||||1.72|0.63|0.862
72487004|NCT03962738|144502523|SUPERIORITY||Odds Ratio (OR)|3.43||||0.112|TWO_SIDED|95.0|0.75|15.65|||Regression, Logistic|||||15.65|0.75|0.112
72487005|NCT03962738|144502523|SUPERIORITY||Odds Ratio (OR)|9.05|||<|0.001|TWO_SIDED|95.0|2.68|30.55|||Regression, Logistic|||||30.55|2.68|<0.001
72487006|NCT03962738|144502523|SUPERIORITY||Odds Ratio (OR)|10.19|||<|0.001|TWO_SIDED|95.0|3.01|34.55|||Regression, Logistic|||||34.55|3.01|<0.001
72487007|NCT03962738|144502524|SUPERIORITY||Odds Ratio (OR)|0.78||||0.343|TWO_SIDED|95.0|0.46|1.31|||Regression, Logistic|||||1.31|0.46|0.343
72487008|NCT03962738|144502524|SUPERIORITY||Odds Ratio (OR)|2.02|||<|0.001|TWO_SIDED|95.0|1.37|2.98|||Regression, Logistic|||||2.98|1.37|<0.001
72487009|NCT03962738|144502524|SUPERIORITY||Odds Ratio (OR)|2.13|||<|0.001|TWO_SIDED|95.0|1.42|3.2|||Regression, Logistic|||||3.20|1.42|<0.001
72487010|NCT03962738|144502525|SUPERIORITY||Odds Ratio (OR)|1.19||||0.605|TWO_SIDED|95.0|0.62|2.26|||Regression, Logistic|||||2.26|0.62|0.605
72487011|NCT03962738|144502525|SUPERIORITY||Odds Ratio (OR)|1.8||||0.015|TWO_SIDED|95.0|1.12|2.9|||Regression, Logistic|||||2.90|1.12|0.015
72487012|NCT03962738|144502525|SUPERIORITY||Odds Ratio (OR)|1.23||||0.432|TWO_SIDED|95.0|0.74|2.05|||Regression, Logistic|||||2.05|0.74|0.432
72487013|NCT03962738|144502526|SUPERIORITY||Odds Ratio (OR)|1.77||||0.166|TWO_SIDED|95.0|0.79|3.96|||Regression, Logistic|||||3.96|0.79|0.166
72513964|NCT00547638|144558700|SUPERIORITY_OR_OTHER|||||||0.883||95.0||||Intent to treat population was analyzed.|Fisher Exact|||||||0.883
72487014|NCT03962738|144502526|SUPERIORITY||Odds Ratio (OR)|1.34||||0.396|TWO_SIDED|95.0|0.68|2.62|||Regression, Logistic|||||2.62|0.68|0.396
72487015|NCT03962738|144502526|SUPERIORITY||Odds Ratio (OR)|1.58||||0.181|TWO_SIDED|95.0|0.81|3.11|||Regression, Logistic|||||3.11|0.81|0.181
72487016|NCT03962738|144502527|SUPERIORITY||Odds Ratio (OR)|1.44||||0.233|TWO_SIDED|95.0|0.79|2.64|||Regression, Logistic|||||2.64|0.79|0.233
72487017|NCT03962738|144502527|SUPERIORITY||Odds Ratio (OR)|1.5||||0.092|TWO_SIDED|95.0|0.94|2.41|||Regression, Logistic|||||2.41|0.94|0.092
72487018|NCT03962738|144502527|SUPERIORITY||Odds Ratio (OR)|1.8||||0.017|TWO_SIDED|95.0|1.11|2.92|||Regression, Logistic|||||2.92|1.11|0.017
72487019|NCT03962738|144502528|SUPERIORITY|||||||0.724|||||||ANCOVA|||||||0.724
72487020|NCT03962738|144502528|SUPERIORITY|||||||0.24|||||||ANCOVA|||||||0.240
72487021|NCT03962738|144502528|SUPERIORITY|||||||0.548|||||||ANCOVA|||||||0.548
72487022|NCT03962738|144502529|SUPERIORITY|||||||0.719|||||||ANCOVA|||||||0.719
72487023|NCT03962738|144502529|SUPERIORITY|||||||0.823|||||||ANCOVA|||||||0.823
72487024|NCT03962738|144502529|SUPERIORITY|||||||0.612|||||||ANCOVA|||||||0.612
72487025|NCT03962738|144502530|SUPERIORITY||Odds Ratio (OR)|1.78||||0.037|TWO_SIDED|95.0|1.04|3.07|||Regression, Logistic|||||3.07|1.04|0.037
72487026|NCT03962738|144502530|SUPERIORITY||Odds Ratio (OR)|2.67|||<|0.001|TWO_SIDED|95.0|1.75|4.06|||Regression, Logistic|||||4.06|1.75|<.001
72487027|NCT03962738|144502530|SUPERIORITY||Odds Ratio (OR)|3.27|||<|0.001|TWO_SIDED|95.0|2.11|5.06|||Regression, Logistic|||||5.06|2.11|<.001
72487028|NCT03962738|144502531|SUPERIORITY|||||||0.162|||||||ANOVA|||Work Functioning||||0.162
72487029|NCT03962738|144502531|SUPERIORITY|||||||0.356|||||||ANOVA|||Social Functioning||||0.356
72487030|NCT03962738|144502531|SUPERIORITY|||||||0.696|||||||ANOVA|||Energy and Vitality||||0.696
72487031|NCT03962738|144502531|SUPERIORITY|||||||0.914|||||||ANOVA|||Feelings and Concerns||||0.914
72487032|NCT03962738|144502531|SUPERIORITY|||||||0.226|||||||ANOVA|||Migraine Symptoms||||0.226
72487033|NCT03962738|144502531|SUPERIORITY|||||||0.31|||||||ANOVA|||Work Functioning||||0.310
72487034|NCT03962738|144502531|SUPERIORITY|||||||0.684|||||||ANOVA|||Social Functioning||||0.684
72487035|NCT03962738|144502531|SUPERIORITY|||||||0.864|||||||ANOVA|||Energy and Vitality||||0.864
72487036|NCT03962738|144502531|SUPERIORITY|||||||0.412|||||||ANOVA|||Feelings and Concerns||||0.412
72487037|NCT03962738|144502531|SUPERIORITY|||||||0.025|||||||ANOVA|||Migraine Symptoms||||0.025
72487038|NCT03962738|144502531|SUPERIORITY|||||||0.619|||||||ANOVA|||Work Functioning||||0.619
72487039|NCT03962738|144502531|SUPERIORITY|||||||0.824|||||||ANOVA|||Social Functioning||||0.824
72487040|NCT03962738|144502531|SUPERIORITY|||||||0.476|||||||ANOVA|||Energy and Vitality||||0.476
72487041|NCT03962738|144502531|SUPERIORITY|||||||0.352|||||||ANOVA|||Feelings and Concerns||||0.352
72487042|NCT03962738|144502531|SUPERIORITY|||||||0.044|||||||ANOVA|||Migraine Symptoms||||0.044
72513965|NCT00547638|144558701|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|||||||1.0000
72513966|NCT01185249|144558715|NON_INFERIORITY_OR_EQUIVALENCE|Null hypothesis-no difference in morning and evening weights on three consecutive days.|Mean Difference (Final Values)|0.62|STANDARD_DEVIATION|3.09|<|0.001|TWO_SIDED|95.0|-0.51306|1.73806|||t-test, 1 sided|||Analysis of within subjects design morning and evening weights. Null hypothesis is that there is no difference between morning and evening weights.||1.73806|-0.51306|<.001
72513967|NCT01185249|144558715|SUPERIORITY_OR_OTHER|||||||0.01||95.0|||||t-test, 1 sided|||||||0.01
72402853|NCT01480076|144311695|SUPERIORITY_OR_OTHER|||||||0.2965|||||||mixed effect model|||Month 12, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % impairment while working due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.2965
72402854|NCT01480076|144311695|SUPERIORITY_OR_OTHER|||||||0.1778|||||||mixed effect model|||Month 12, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % impairment while working due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.1778
72402855|NCT01480076|144311695|SUPERIORITY_OR_OTHER||difference of LS means|6.6|STANDARD_ERROR_OF_MEAN|7.65||0.3903|TWO_SIDED||||||mixed effect model|||Month 12, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % impairment while working due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.3903
72402856|NCT01480076|144311695|SUPERIORITY_OR_OTHER||difference of LS means|16.8|STANDARD_ERROR_OF_MEAN|15.53||0.2794|TWO_SIDED||||||mixed effect model|||Month 12, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % impairment while working due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.2794
72402857|NCT01480076|144311696|SUPERIORITY_OR_OTHER|||||||0.0628|||||||mixed effect model|||Overall, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % overall work impairment due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0628
72402858|NCT01480076|144311696|SUPERIORITY_OR_OTHER|||||||0.1166|||||||mixed effect model|||Overall, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % overall work impairment due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.1166
72402859|NCT01480076|144311696|SUPERIORITY_OR_OTHER|||||||0.0451|||||||mixed effect model|||Overall, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % overall work impairment due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0451
72402860|NCT01480076|144311696|SUPERIORITY_OR_OTHER|||||||0.9327|||||||mixed effect model|||Overall, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % overall work impairment due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.9327
72402861|NCT01480076|144311696|SUPERIORITY_OR_OTHER||difference of LS means|5.1|STANDARD_ERROR_OF_MEAN|6.28||0.4177|TWO_SIDED||||||mixed effect model|||Overall, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % overall work impairment due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.4177
72402862|NCT01480076|144311696|SUPERIORITY_OR_OTHER||difference of LS means|-7.9|STANDARD_ERROR_OF_MEAN|14.64||0.5885|TWO_SIDED||||||mixed effect model|||Overall, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % overall work impairment due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.5885
72487043|NCT00509067|144502533|SUPERIORITY|||||||0.93||||||alpha set at P \< .05|Mixed Models Analysis|Time (0, 4, 8, 12, 16 wks) x Treatment (Drug, Placebo) Effect: F(1, 33)=0.01.||||||0.93
72487044|NCT00509067|144502534|SUPERIORITY|||||||0.23||||||alpha level set at .05|Mixed Models Analysis|Time (0, 8, 16 weeks) x Group (Drug, Placebo) Effect: F(1, 32.8)=1.48..||||||0.23
72402863|NCT01480076|144311696|SUPERIORITY_OR_OTHER|||||||0.0059|||||||mixed effect model|||Month 3, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % overall work impairment due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0059
72487045|NCT00509067|144502534|SUPERIORITY|||||||0.23||||||alpha set at P\<0.05|Mixed Models Analysis|Time (0, 8, 16, weeks) x Group (Drug, Placebo) Effect: F(1, 32.8)=1.48.||||||0.23
72513968|NCT00406783|144558719|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||ANOVA|||||||<0.001
72513969|NCT00406783|144558720|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||ANOVA|||||||<0.001
72513970|NCT02300077|144558769|SUPERIORITY|||||||0.0001|||||||Chi-squared|||||||0.0001
72513971|NCT02300077|144558770|SUPERIORITY|||||||0.01|||||||Kruskal-Wallis|||||||0.01
72513972|NCT02300077|144558771|SUPERIORITY|||||||0.001|||||||Kruskal-Wallis|||||||0.001
72513973|NCT02300077|144558772|SUPERIORITY|||||||0.02|||||||Kruskal-Wallis|||||||0.02
72402864|NCT01480076|144311696|SUPERIORITY_OR_OTHER|||||||0.3467|||||||mixed effect model|||Month 3, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % overall work impairment due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.3467
72402865|NCT01480076|144311696|SUPERIORITY_OR_OTHER|||||||0.0654|||||||mixed effect model|||Month 3, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % overall work impairment due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0654
72402866|NCT01480076|144311696|SUPERIORITY_OR_OTHER|||||||0.3965|||||||mixed effect model|||Month 3, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % overall work impairment due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.3965
72402867|NCT01480076|144311696|SUPERIORITY_OR_OTHER||difference of LS means|-1.3|STANDARD_ERROR_OF_MEAN|7.11||0.8548|TWO_SIDED||||||mixed effect model|||Month 3, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % overall work impairment due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.8548
72402868|NCT01480076|144311696|SUPERIORITY_OR_OTHER||difference of LS means|-25.1|STANDARD_ERROR_OF_MEAN|21.35||0.2405|TWO_SIDED||||||mixed effect model|||Month 3, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % overall work impairment due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.2405
72402869|NCT01480076|144311696|SUPERIORITY_OR_OTHER|||||||0.0056|||||||mixed effect model|||Month 6, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % overall work impairment due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0056
72402870|NCT01480076|144311696|SUPERIORITY_OR_OTHER|||||||0.8105|||||||mixed effect model|||Month 6, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % overall work impairment due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.8105
72513974|NCT03260205|144558773|SUPERIORITY||Difference in Least Square Mean|-5.9||||0.0242|TWO_SIDED|95.0|-11.01|-0.78|||MMRM|||This outcome measure was analyzed using the linear mixed-effects model for repeated measures (MMRM). From a MMRM analysis over all post-baseline visits, with the change from baseline in ADHD-RS-IV preschool version total score as the outcome, treatment, visit, and treatment-by-visit interaction as fixed effect, baseline ADHD-RS-IV and baseline ADHD-RS-IV score-by-visit interaction as covariates.||-0.78|-11.01|0.0242
72513975|NCT03260205|144558774|SUPERIORITY||Difference in Least Mean Square|-0.6||||0.0074|TWO_SIDED|95.0|-1.03|-0.16|||MMRM|||This outcome measure was analyzed using the linear mixed-effects model for repeated measures (MMRM). From a MMRM analysis over all post-baseline Visits, with the CGI-I score as the outcome, treatment, visit, and treatment-by-visit interaction as fixed effect, baseline CGI-S as covariate.||-0.16|-1.03|0.0074
72513976|NCT03003403|144558812|SUPERIORITY||Risk Ratio (RR)|1.0||||0.97|TWO_SIDED|95.0|0.82|1.2|||bootstrap resampling|||||1.20|0.82|0.97
72513977|NCT03003403|144558813|SUPERIORITY||Mean Difference (Final Values)|-0.12||||0.83|TWO_SIDED|95.0|-1.24|1.0|||Mixed Models Analysis|||||1.00|-1.24|0.83
72513978|NCT03003403|144558814|SUPERIORITY|Difference in systolic blood pressure change post-baseline comparing intervention to usual care arm at 24 months.|Mean Difference (Final Values)|-1.2||||0.34|TWO_SIDED|95.0|-3.6|1.3|||Mixed Models Analysis|||||1.3|-3.6|0.34
72513979|NCT03003403|144558814|SUPERIORITY|Difference in diastolic blood pressure change post-baseline comparing intervention to usual care arm at 24 months.|Mean Difference (Final Values)|-0.8||||0.323|TWO_SIDED|95.0|-2.4|0.8|||Mixed Models Analysis|||||0.8|-2.4|0.323
72513980|NCT03003403|144558815|SUPERIORITY||Mean Difference (Final Values)|-0.005||||0.991|TWO_SIDED|95.0|-0.8|0.8|||Mixed Models Analysis|||||0.8|-0.8|0.991
72402871|NCT01480076|144311696|SUPERIORITY_OR_OTHER|||||||0.047|||||||mixed effect model|||Month 6, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % overall work impairment due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0470
72513981|NCT03006471|144558858|SUPERIORITY|||||||0.755||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values in placebo group||||0.755
72513982|NCT03006471|144558858|SUPERIORITY|||||||0.046||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values in dapagliflozin group||||0.046
72513983|NCT03006471|144558859|SUPERIORITY|||||||0.752||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values in placebo group||||0.752
72513984|NCT03006471|144558859|SUPERIORITY|||||||0.582||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values in dapagliflozin group||||0.582
72402872|NCT01480076|144311696|SUPERIORITY_OR_OTHER|||||||0.6067|||||||mixed effect model|||Month 6, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % overall work impairment due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.6067
72513985|NCT03006471|144558860|SUPERIORITY|||||||0.814||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values in placebo group||||0.814
72513986|NCT03006471|144558860|SUPERIORITY|||||||0.22||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values in dapagliflozin group||||0.220
72513987|NCT03006471|144558861|SUPERIORITY|||||||0.624||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values in placebo group||||0.624
72513988|NCT03006471|144558861|SUPERIORITY|||||||1||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values in dapagliflozin group||||1.000
72513989|NCT03006471|144558862|SUPERIORITY|||||||0.906||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values in placebo group||||0.906
72513990|NCT03006471|144558862|SUPERIORITY|||||||0.017||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values in dapagliflozin group||||0.017
72513991|NCT03006471|144558863|SUPERIORITY|||||||0.454||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values in placebo group||||0.454
72487046|NCT03654976|144502565|SUPERIORITY||Rate ratio|0.89||||0.5412|TWO_SIDED|95.0|0.6|1.31|||Negative binomial regression||12 SQ-HDM SLIT-tablet as the numerator and placebo SLIT-tablet as the denominator.|The number of clinically relevant asthma exacerbations was analyzed using a negative binomial regression model with a log-link function and the logarithm of the time in years in the efficacy period as offset. The model included treatment, age group (\<12 years, \>=12 years) and region (west: DEU, ESP, FRA, GBR and USA; central: POL; east: BGR, HUN and RUS) as fixed factors. No missing data approach was applied.||1.31|0.60|0.5412
72487047|NCT03654976|144502566|SUPERIORITY||Odds Ratio (OR)|0.7713||||0.4156|TWO_SIDED|95.0|0.41|1.44|||Marginal logistic regression||12 SQ-HDM SLIT-tablet as the numerator and placebo SLIT-tablet as the denominator.|A marginal logistic regression model with a generalized estimating approach was analyzed using treatment, visit, treatment\*visit, age group (\<12 years, \>=12 years) and region (west: DEU, ESP, FRA, GBR and USA; central: POL; east: BGR, HUN and RUS) as fixed factors. Baseline visit was included as a covariate. No missing data approach was applied.||1.44|0.41|0.4156
72487048|NCT03654976|144502567|SUPERIORITY||Odds Ratio (OR)|0.8477||||0.4146|TWO_SIDED|95.0|0.57|1.26|||Marginal logistic regression||12 SQ-HDM SLIT-tablet as the numerator and placebo SLIT-tablet as the denominator.|A marginal logistic regression model with a generalized estimating approach was analyzed using treatment, visit, treatment\*visit, age group (\<12 years, \>=12 years) and region (west: DEU, ESP, FRA, GBR and USA; central: POL; east: BGR, HUN and RUS) as fixed factors. Baseline visit is included as a covariate. No missing data approach was applied.||1.26|0.57|0.4146
72487049|NCT03654976|144502568|SUPERIORITY||Mean Difference (Final Values)|0.12||||0.8829|TWO_SIDED|95.0|-1.47|1.7|||Mixed-effect model repeated measurement||12 SQ-HDM - placebo|A 'mixed-effect model repeated measurement' model was analysed using treatment, visit, treatment\*visit, age group (\<12 years, \>=12 years) and region (west: DEU, ESP, FRA, GBR and USA; central: POL; east: BGR, HUN and RUS) as fixed factors. Baseline visit was included as a covariate. No missing data approach was applied.||1.70|-1.47|0.8829
72487050|NCT03654976|144502569|SUPERIORITY||Odds Ratio (OR)|2.26||||0.0044|TWO_SIDED|95.0|1.29|3.96|||Generalised linear mixed model||12 SQ-HDM SLIT-tablet as the numerator and placebo SLIT-tablet as the denominator.|The odds of having an improved outcome was analyzed using a generalized linear mixed model (GLMM) with a logit link function. The model included treatment, age group (\<12 years, \>=12 years) and region (west: DEU, ESP, FRA, GBR and USA; central: POL; east: BGR, HUN and RUS) as fixed factors. No missing data approach was applied.||3.96|1.29|0.0044
72487051|NCT03654976|144502570|SUPERIORITY||Odds Ratio, log|1.62||||0.0698|TWO_SIDED|95.0|0.96|2.74|||Generalised linear mixed model||12 SQ-HDM SLIT-tablet as the numerator and placebo SLIT-tablet as the denominator.|The odds of having an improved outcome was analysed using a generalised linear mixed model (GLMM) with a logit link function. The model included treatment, age group (\<12 years, \>=12 years) and region (west: DEU, ESP, FRA, GBR and USA; central: POL; east: BGR, HUN and RUS) as fixed factors. No missing data approach was applied.||2.74|0.96|0.0698
72487052|NCT00117598|144502573|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.39|||<|0.0001|TWO_SIDED|95.0|0.25|0.63|||Log Rank||HR from a cox model adjusted for baseline stratification factors|Two null hypotheses (Ho) tested: 1. PFS distributions for temsirolimus 175/75 mg and investigator's choice treatment groups are identical. 2. PFS distributions for temsirolimus 175/25 mg and investigator's choice treatment groups are identical. Alternative hypothesis (Ha) for each test was that PFS distributions differed.||0.63|0.25|<0.0001
72513992|NCT03006471|144558863|SUPERIORITY|||||||0.115||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values in dapagliflozin group||||0.115
72513993|NCT03006471|144558864|SUPERIORITY|||||||0.422||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values in placebo group||||0.422
72513994|NCT03006471|144558864|SUPERIORITY|||||||0.917||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values in dapagliflozin group||||0.917
72513995|NCT03006471|144558865|SUPERIORITY|||||||0.65||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values in placebo group||||0.650
72402873|NCT01480076|144311696|SUPERIORITY_OR_OTHER||difference of LS means|-6.0|STANDARD_ERROR_OF_MEAN|7.56||0.4309|TWO_SIDED||||||mixed effect model|||Month 6, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % overall work impairment due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.4309
72402874|NCT01480076|144311696|SUPERIORITY_OR_OTHER||difference of LS means|0.5|STANDARD_ERROR_OF_MEAN|16.09||0.9761|TWO_SIDED||||||mixed effect model|||Month 6, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % overall work impairment due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.9761
72402875|NCT01480076|144311696|SUPERIORITY_OR_OTHER|||||||0.6261|||||||mixed effect model|||Month 9, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % overall work impairment due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.6261
72402876|NCT01480076|144311696|SUPERIORITY_OR_OTHER|||||||0.086|||||||mixed effect model|||Month 9, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % overall work impairment due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0860
72402877|NCT01480076|144311696|SUPERIORITY_OR_OTHER|||||||0.2884|||||||mixed effect model|||Month 9, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % overall work impairment due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.2884
72402878|NCT01480076|144311696|SUPERIORITY_OR_OTHER|||||||0.8854|||||||mixed effect model|||Month 9, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % overall work impairment due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.8854
72513996|NCT03006471|144558865|SUPERIORITY|||||||0.108||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values in dapagliflozin group||||0.108
72513997|NCT03006471|144558866|SUPERIORITY|||||||0.875||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values in placebo group||||0.875
72513998|NCT03006471|144558866|SUPERIORITY|||||||0.196||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of waist circumference in dapagliflozin group||||0.196
72513999|NCT03006471|144558867|SUPERIORITY|||||||0.552||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values in placebo group||||0.552
72514000|NCT03006471|144558867|SUPERIORITY|||||||0.087||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values in dapagliflozin group||||0.087
72514001|NCT03006471|144558868|SUPERIORITY|||||||0.814||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values in placebo group||||0.814
72402879|NCT01480076|144311696|SUPERIORITY_OR_OTHER||difference of LS means|16.9|STANDARD_ERROR_OF_MEAN|10.88||0.1226|TWO_SIDED||||||mixed effect model|||Month 9, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % overall work impairment due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.1226
72402880|NCT01480076|144311696|SUPERIORITY_OR_OTHER||difference of LS means|-9.2|STANDARD_ERROR_OF_MEAN|26.07||0.7249|TWO_SIDED||||||mixed effect model|||Month 9, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % overall work impairment due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.7249
72514002|NCT03006471|144558868|SUPERIORITY|||||||0.463||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values in dapagliflozin group||||0.463
72514003|NCT03006471|144558869|SUPERIORITY|||||||0.53||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values in placebo group||||0.530
72514004|NCT03006471|144558869|SUPERIORITY|||||||0.507||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values in dapagliflozin group||||0.507
72514005|NCT03006471|144558870|SUPERIORITY|||||||0.152||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values in placebo group||||0.152
72567927|NCT02037165|144667468|SUPERIORITY_OR_OTHER||adjusted mean difference|-0.84|STANDARD_ERROR_OF_MEAN|1.8566|||TWO_SIDED|95.0|-4.5|2.8|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 24:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||2.8|-4.5|
72567928|NCT02037165|144667468|SUPERIORITY_OR_OTHER||adjusted mean difference|-1.1|STANDARD_ERROR_OF_MEAN|1.8257|||TWO_SIDED|95.0|-4.7|2.5|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 0:30h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||2.5|-4.7|
72402881|NCT01480076|144311696|SUPERIORITY_OR_OTHER|||||||0.5129|||||||mixed effect model|||Month 12, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % overall work impairment due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.5129
72402882|NCT01480076|144311696|SUPERIORITY_OR_OTHER|||||||0.1138|||||||mixed effect model|||Month 12, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % overall work impairment due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.1138
72567929|NCT02037165|144667468|SUPERIORITY_OR_OTHER||adjusted mean difference|-3.98|STANDARD_ERROR_OF_MEAN|1.8254|||TWO_SIDED|95.0|-7.6|-0.4|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 1:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||-0.4|-7.6|
72567930|NCT02037165|144667468|SUPERIORITY_OR_OTHER||adjusted mean difference|-2.43|STANDARD_ERROR_OF_MEAN|1.8252|||TWO_SIDED|95.0|-6.0|1.2|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 2:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||1.2|-6.0|
72567931|NCT02037165|144667468|SUPERIORITY_OR_OTHER||adjusted mean difference|-1.29|STANDARD_ERROR_OF_MEAN|1.8251|||TWO_SIDED|95.0|-4.9|2.3|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 3:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||2.3|-4.9|
72567932|NCT02037165|144667468|SUPERIORITY_OR_OTHER||Slope|-1.72|STANDARD_ERROR_OF_MEAN|1.825|||TWO_SIDED|95.0|-5.3|1.9|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 4:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||1.9|-5.3|
72567933|NCT02037165|144667468|SUPERIORITY_OR_OTHER||adjusted mean difference|-0.23|STANDARD_ERROR_OF_MEAN|1.8251|||TWO_SIDED|95.0|-3.8|3.4|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 5:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||3.4|-3.8|
72577030|NCT00261443|144680750|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.1||||0.235|TWO_SIDED|95.0|-0.07|0.27||ANOVA model, controlling for treatment and mood stabilizer, is used for baseline. ANCOVA model, controlling for treatment, mood stabilizer, and baseline value, is used for mean change from baseline.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences and p-values are based on the ANOVA/ANCOVA model.||Week 52 LOCF Treatment Difference||0.27|-0.07|0.235
72402883|NCT01480076|144311696|SUPERIORITY_OR_OTHER|||||||0.1086|||||||mixed effect model|||Month 12, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % overall work impairment due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.1086
72402884|NCT01480076|144311696|SUPERIORITY_OR_OTHER|||||||0.5746|||||||mixed effect model|||Month 12, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % overall work impairment due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.5746
72567934|NCT02037165|144667468|SUPERIORITY_OR_OTHER||adjusted mean difference|-1.46|STANDARD_ERROR_OF_MEAN|1.8252|||TWO_SIDED|95.0|-5.0|2.1|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 6:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||2.1|-5.0|
72567935|NCT02037165|144667468|SUPERIORITY_OR_OTHER||adjusted mean difference|-2.65|STANDARD_ERROR_OF_MEAN|1.8254|||TWO_SIDED|95.0|-6.2|0.9|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 22:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||0.9|-6.2|
72567936|NCT02037165|144667468|SUPERIORITY_OR_OTHER||adjusted mean difference|-0.31|STANDARD_ERROR_OF_MEAN|1.8257|||TWO_SIDED|95.0|-3.9|3.3|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 24:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||3.3|-3.9|
72567937|NCT02037165|144667469|SUPERIORITY_OR_OTHER||adjusted mean difference|-0.16|STANDARD_ERROR_OF_MEAN|1.3652|||TWO_SIDED|95.0|-2.8|2.5|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 0:30h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||2.5|-2.8|
72567938|NCT02037165|144667469|SUPERIORITY_OR_OTHER||adjusted mean difference|2.18|STANDARD_ERROR_OF_MEAN|1.3652|||TWO_SIDED|95.0|-0.5|4.9|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 1:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||4.9|-0.5|
72567939|NCT02037165|144667469|SUPERIORITY_OR_OTHER||adjusted mean difference|1.01|STANDARD_ERROR_OF_MEAN|1.3652|||TWO_SIDED|95.0|-1.7|3.7|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 2:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||3.7|-1.7|
72624134|NCT01892189|144778533|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2051|STANDARD_ERROR_OF_MEAN|0.20032||0.313|TWO_SIDED|95.0|-0.6122|0.202|||ANOVA||Difference between least square means of TAK-063 3 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Left Ventrolateral Prefrontal Cortex: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.2020|-0.6122|0.313
72624135|NCT01892189|144778533|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0253|STANDARD_ERROR_OF_MEAN|0.21616||0.908|TWO_SIDED|95.0|-0.414|0.4646|||ANOVA||Difference between least square means of TAK-063 10 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Left Ventrolateral Prefrontal Cortex: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.4646|-0.4140|0.908
72402885|NCT01480076|144311696|SUPERIORITY_OR_OTHER||difference of LS means|10.8|STANDARD_ERROR_OF_MEAN|8.07||0.1831|TWO_SIDED||||||mixed effect model|||Month 12, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % overall work impairment due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.1831
72487053|NCT00117598|144502573|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.41|||<|0.0001|TWO_SIDED|95.0|0.26|0.65|||Log Rank||HR from a cox model adjusted for baseline stratification factors|||0.65|0.26|<0.0001
72487054|NCT00117598|144502574|SUPERIORITY_OR_OTHER|||||||0.0019|TWO_SIDED||||||Fisher Exact|||||||0.0019
72487055|NCT00117598|144502574|SUPERIORITY_OR_OTHER|||||||0.6179|TWO_SIDED||||||Fisher Exact|||||||0.6179
72567940|NCT02037165|144667469|SUPERIORITY_OR_OTHER||adjusted mean difference|1.26|STANDARD_ERROR_OF_MEAN|1.3652|||TWO_SIDED|95.0|-1.4|3.9|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 3:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||3.9|-1.4|
72402886|NCT01480076|144311696|SUPERIORITY_OR_OTHER||difference of LS means|2.1|STANDARD_ERROR_OF_MEAN|15.54||0.8917|TWO_SIDED||||||mixed effect model|||Month 12, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % overall work impairment due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.8917
72402887|NCT01480076|144311697|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Overall, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the regular activity productivity loss, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
72487056|NCT00117598|144502575|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.77||||0.3053|TWO_SIDED|95.0|0.46|1.28|||Log Rank||HR from a cox model adjusted for baseline stratification factors|||1.28|0.46|0.3053
72487057|NCT00117598|144502575|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.98||||0.9515|TWO_SIDED|95.0|0.6|1.62|||Log Rank||HR from a cox model adjusted for baseline stratification factors|||1.62|0.60|0.9515
72514006|NCT03006471|144558870|SUPERIORITY|||||||0.972||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values in dapagliflozin group||||0.972
72514007|NCT03006471|144558871|SUPERIORITY|||||||0.152||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values in placebo group||||0.152
72514008|NCT03006471|144558871|SUPERIORITY|||||||0.158||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values in dapagliflozin group||||0.158
72514009|NCT03006471|144558872|SUPERIORITY|||||||0.944||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values in placebo group||||0.944
72514010|NCT03006471|144558872|SUPERIORITY|||||||0.65||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values in dapagliflozin group||||0.650
72514011|NCT03006471|144558873|SUPERIORITY|||||||0.087||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values in placebo group||||0.087
72514012|NCT03006471|144558873|SUPERIORITY|||||||0.345||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values in dapagliflozin group||||0.345
72577031|NCT00261443|144680750|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.36||||0.012|TWO_SIDED|95.0|0.08|0.64||ANOVA model, controlling for treatment and mood stabilizer, is used for baseline. ANCOVA model, controlling for treatment, mood stabilizer, and baseline value, is used for mean change from baseline.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences and p-values are based on the ANOVA/ANCOVA model.||Highest Value in Change Treatment Difference||0.64|0.08|0.012
72514013|NCT03006471|144558874|SUPERIORITY|||||||0.115||||||The threshold for statistical significance was p=0.05|Chi-squared|||Results showed in this section are the result of the differences between change of intervention group||||0.115
72514014|NCT03006471|144558875|SUPERIORITY|||||||0.047||||||The threshold for statistical significance was p=0.05|Chi-squared|||Results showed in this section are the result of the differences between change of intervention groups||||0.047
72487058|NCT00117598|144502576|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.11|||||TWO_SIDED|95.0|0.14|9.01|||||HR from a cox model adjusted for baseline stratification factors|||9.01|0.14|
72487059|NCT00117598|144502576|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.14|||||TWO_SIDED|95.0|0.1|13.3|||||HR from a cox model adjusted for baseline stratification factors|||13.3|0.10|
72487060|NCT00117598|144502578|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.36|||<|0.0001|TWO_SIDED|95.0|0.23|0.56|||Log Rank||HR from a cox model adjusted for baseline stratification factors|||0.56|0.23|<0.0001
72514015|NCT03006471|144558876|SUPERIORITY|||||||0.539||||||The threshold for statistical significance was p=0.05|Chi-squared|||Results showed in this section are the result of the differences between change of intervention groups||||0.539
72514016|NCT03006471|144558877|SUPERIORITY|||||||0.844||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values in placebo group||||0.844
72514017|NCT03006471|144558877|SUPERIORITY|||||||0.01||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values in dapagliflozin group||||0.010
72514018|NCT03006471|144558878|SUPERIORITY|||||||0.814||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values in placebo group||||0.814
72514019|NCT03006471|144558878|SUPERIORITY|||||||0.011||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values in dapagliflozin group||||0.011
72514020|NCT03006471|144558879|SUPERIORITY|||||||0.221||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values in placebo group||||0.221
72402888|NCT01480076|144311697|SUPERIORITY_OR_OTHER|||||||0.1152|||||||mixed effect model|||Overall, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the regular activity productivity loss, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.1152
72402889|NCT01480076|144311697|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Overall, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the regular activity productivity loss, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
72402890|NCT01480076|144311697|SUPERIORITY_OR_OTHER|||||||0.4578|||||||mixed effect model|||Overall, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the regular activity productivity loss, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.4578
72402891|NCT01480076|144311697|SUPERIORITY_OR_OTHER||difference of LS means|-6.4|STANDARD_ERROR_OF_MEAN|2.56||0.0125|TWO_SIDED||||||mixed effect model|||Overall, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the regular activity productivity loss, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0125
72402892|NCT01480076|144311697|SUPERIORITY_OR_OTHER||difference of LS means|-10.2|STANDARD_ERROR_OF_MEAN|4.23||0.0158|TWO_SIDED||||||mixed effect model|||Overall, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the regular activity productivity loss, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0158
72402893|NCT01480076|144311697|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 3, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the regular activity productivity loss, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
72402894|NCT01480076|144311697|SUPERIORITY_OR_OTHER|||||||0.2894|||||||mixed effect model|||Month 3, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the regular activity productivity loss, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.2894
72402895|NCT01480076|144311697|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 3, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the regular activity productivity loss, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
72402896|NCT01480076|144311697|SUPERIORITY_OR_OTHER|||||||0.723|||||||mixed effect model|||Month 3, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the regular activity productivity loss, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.7230
72402897|NCT01480076|144311697|SUPERIORITY_OR_OTHER||difference of LS means|-9.3|STANDARD_ERROR_OF_MEAN|3.2||0.0038|TWO_SIDED||||||mixed effect model|||Month 3, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the regular activity productivity loss, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0038
72402898|NCT01480076|144311697|SUPERIORITY_OR_OTHER||difference of LS means|-13.9|STANDARD_ERROR_OF_MEAN|5.37||0.0097|TWO_SIDED||||||mixed effect model|||Month 3, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the regular activity productivity loss, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0097
72514021|NCT03006471|144558879|SUPERIORITY|||||||0.001||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values in dapagliflozin group||||0.001
72514022|NCT03006471|144558880|SUPERIORITY|||||||0.461||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values in placebo group||||0.461
72514023|NCT03006471|144558880|SUPERIORITY|||||||0.011||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values in dapagliflozin group||||0.011
72514024|NCT03006471|144558881|SUPERIORITY|||||||0.285||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values in placebo group||||0.285
72577032|NCT00261443|144680751|SUPERIORITY_OR_OTHER_LEGACY|||||||0.587||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Baseline Heart Rate||||0.587
72577033|NCT00261443|144680751|SUPERIORITY_OR_OTHER_LEGACY|||||||0.386||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison, Change from Baseline in Heart Rate at Week 52 (LOCF)||||0.386
72487061|NCT00117598|144502578|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.39|||<|0.0001|TWO_SIDED|95.0|0.26|0.6|||Log Rank||HR from a cox model adjusted for baseline stratification factors|||0.60|0.26|<0.0001
72487062|NCT00117598|144502579|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.39||||0.0004|TWO_SIDED|95.0|0.23|0.67|||Log Rank||HR from a cox model adjusted for baseline stratification factors|||0.67|0.23|0.0004
72402899|NCT01480076|144311697|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 6, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the regular activity productivity loss, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
72402900|NCT01480076|144311697|SUPERIORITY_OR_OTHER|||||||0.0628|||||||mixed effect model|||Month 6, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the regular activity productivity loss, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0628
72402901|NCT01480076|144311697|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 6, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the regular activity productivity loss, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
72402902|NCT01480076|144311697|SUPERIORITY_OR_OTHER|||||||0.9232|||||||mixed effect model|||Month 6, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the regular activity productivity loss, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.9232
72402903|NCT01480076|144311697|SUPERIORITY_OR_OTHER||difference of LS means|-5.2|STANDARD_ERROR_OF_MEAN|3.37||0.1249|TWO_SIDED||||||mixed effect model|||Month 6, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the regular activity productivity loss, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.1249
72402904|NCT01480076|144311697|SUPERIORITY_OR_OTHER||difference of LS means|-14.1|STANDARD_ERROR_OF_MEAN|5.42||0.0093|TWO_SIDED||||||mixed effect model|||Month 6, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the regular activity productivity loss, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0093
72514025|NCT03006471|144558881|SUPERIORITY|||||||0.002||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values in dapagliflozin group||||0.002
72514026|NCT03006471|144558882|SUPERIORITY|||||||0.701||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values in placebo group||||0.701
72514027|NCT03006471|144558882|SUPERIORITY|||||||0.081||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values in dapagliflozin group||||0.081
72514028|NCT03006471|144558883|SUPERIORITY|||||||0.581||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values in placebo group||||0.581
72514029|NCT03006471|144558883|SUPERIORITY|||||||0.004||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of HDL-cholesterol on dapagliflozin group||||0.004
72487063|NCT00117598|144502579|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.64||||0.0712|TWO_SIDED|95.0|0.4|1.04|||Log Rank||HR from a cox model adjusted for baseline stratification factors|||1.04|0.40|0.0712
72514030|NCT03006471|144558884|SUPERIORITY|||||||0.727||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values in placebo group||||0.727
72487064|NCT04688775|144502589|SUPERIORITY||Mean Difference (Final Values)|0.7||||0.5048|TWO_SIDED|95.0|-1.3|2.6|||Mixed Models Repeated Measures|||Change From Baseline in the Number of Weekly Attacks: Eptinezumab vs. Placebo||2.6|-1.3|0.5048
72487065|NCT04688775|144502594|SUPERIORITY||Hazard Ratio (HR)|1.45||||0.0772|TWO_SIDED|95.0|0.96|2.17|||Regression, Cox|||||2.17|0.96|0.0772
72487066|NCT04261504|144502634|SUPERIORITY|||||||0.03||||||Threshold p\<0.05.|threshold-free cluster enhancement|||||||0.03
72487067|NCT00382018|144502642|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.0||||0.98|TWO_SIDED|95.0|0.69|1.47|||Log Rank|||Hazard Ration of overall survival compared Arm C2 to Arm C1.||1.47|0.69|0.98
72487068|NCT00382018|144502643|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.92||||0.64|TWO_SIDED|95.0|0.64|1.32|||Log Rank|||Hazard Ratio of progression free survival compared Arm C2 to Arm C1||1.32|0.64|0.64
72514031|NCT03006471|144558884|SUPERIORITY|||||||0.451||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values in dapagliflozin group||||0.451
72514032|NCT03006471|144558885|SUPERIORITY|||||||0.463||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values in placebo group||||0.463
72514033|NCT03006471|144558885|SUPERIORITY|||||||0.043||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values in dapagliflozin group||||0.043
72577034|NCT00261443|144680751|SUPERIORITY_OR_OTHER_LEGACY|||||||0.405||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Highest Value of Change in Heart Rate, Phase 3||||0.405
72487069|NCT00789880|144502648|SUPERIORITY_OR_OTHER|||||||0.7|||||||ANOVA|P-value is not adjusted for multiple comparisons.||Testing whether the change in CAMP expression in lesional skin of AD participants differs by treatment group.||||0.7
72487070|NCT00789880|144502648|SUPERIORITY_OR_OTHER|||||||0.12|||||||ANOVA|P-value is not adjusted for multiple comparisons.||Testing whether the change in CAMP mRNA expression in non-lesional skin of AD participants differs by treatment group.||||0.12
72487071|NCT00789880|144502649|SUPERIORITY_OR_OTHER|||||||0.3|||||||ANOVA|P-value is not adjusted for multiple comparisons.||Testing whether the change in CAMP mRNA expression in non-lesional skin of Non-AD participants differs by treatment group.||||0.3
72487072|NCT00789880|144502650|SUPERIORITY_OR_OTHER|||||||0.4|||||||ANOVA|P-value is not adjusted for multiple comparisons.||Testing whether change in CAMP mRNA expression in lesional skin of psoriatic participants differs by treatment group.||||0.4
72487073|NCT00789880|144502650|SUPERIORITY_OR_OTHER|||||||0.2|||||||ANOVA|P-value is not adjusted for multiple comparisons.||Testing whether change in CAMP mRNA expression in non-lesional skin of psoriatic participants differs by treatment group.||||0.2
72487074|NCT00789880|144502651|SUPERIORITY_OR_OTHER|||||||0.8|||||||ANOVA|P-value is not adjusted for multiple comparisons.||Testing whether change in HBD-3 mRNA expression in lesional skin of AD participants differs by treatment group.||||0.8
72487075|NCT00789880|144502651|SUPERIORITY_OR_OTHER|||||||0.2|||||||ANOVA|P-value is not adjusted for multiple comparisons.||Testing whether change in HBD-3 mRNA expression in non-lesional skin of AD participants differs by treatment group.||||0.2
72487076|NCT00789880|144502652|SUPERIORITY_OR_OTHER|||||||0.4||||||P-value is not adjusted for multiple comparisons.|ANOVA|||Testing whether change in HBD-3 mRNA expression in non-lesional skin of Non-AD participants differs by treatment group.||||0.4
72487077|NCT00789880|144502653|SUPERIORITY_OR_OTHER|||||||0.4||||||P-value is not adjusted for multiple comparisons.|ANOVA|||Testing whether change in HBD-3 mRNA expression in lesional skin of psoriatic participants differs by treatment group.||||0.4
72487078|NCT00789880|144502653|SUPERIORITY_OR_OTHER|||||||1||||||P-value is not adjusted for multiple comparisons.|ANOVA|||Testing whether change in HBD-3 mRNA expression in non-lesional skin of psoriatic participants differs by treatment group.||||1.0
72487079|NCT00789880|144502654|SUPERIORITY_OR_OTHER|||||||0.2||||||P-value is not adjusted for multiple comparisons.|ANOVA|||Testing whether change in IL-13 mRNA expression in lesional skin of AD participants differs by treatment group.||||0.2
72487080|NCT00789880|144502654|SUPERIORITY_OR_OTHER|||||||0.5||||||P-value is not adjusted for multiple comparisons.|ANOVA|||Testing whether change in IL-13 mRNA expression in non-lesional skin of AD participants differs by treatment group.||||0.5
72487081|NCT00789880|144502655|SUPERIORITY_OR_OTHER|||||||0.7||||||P-value is not adjusted for multiple comparisons.|ANOVA|||Testing whether change in IL-13 mRNA expression in non-lesional skin of Non-AD participants differs by treatment group.||||0.7
72514034|NCT03006471|144558886|SUPERIORITY|||||||0.807||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values in placebo group||||0.807
72487082|NCT00789880|144502656|SUPERIORITY_OR_OTHER|||||||0.2||||||P-value is not adjusted for multiple comparisons.|ANOVA|||Testing whether change in IL-13 mRNA expression in lesional skin of psoriatic participants differs by treatment group.||||0.2
72487083|NCT00789880|144502656|SUPERIORITY_OR_OTHER|||||||0.3||||||P-value is not adjusted for multiple comparisons.|ANOVA|||Testing whether change in IL-13 mRNA expression in non-lesional skin of psoriatic participants differs by treatment group.||||0.3
72487084|NCT02568475|144502665|EQUIVALENCE|Continuous scale: score compares results before and after intervention without a cut parameter.|Mean Difference (Final Values)|3.59|STANDARD_ERROR_OF_MEAN|1.74||0.046|TWO_SIDED|95.0|0.059|7.12|||t-test, 2 sided|||||7.12|0.059|0.046
72487085|NCT02568475|144502666|OTHER|This is a continuous scale with no clinical cut score/value. We tested mean differences between the two groups.|Mean Difference (Final Values)|6.78||||0.001|TWO_SIDED|95.0|2.9|10.6|||t-test, 2 sided|||||10.6|2.9|0.001
72487086|NCT00493220|144502670|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence = 90% confidence interval of least squares mean (LSM) within 80%-125%|LSM ratio (natural log-transformed)|111.79|||||TWO_SIDED|90.0|108.57|115.12|||Schuirmann two one-sided tests procedure||HYLENEX SC/Placebo SC|||115.12|108.57|
72487087|NCT00493220|144502670|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence = 90% confidence interval of least squares mean (LSM) within 80%-125%|LSM ratio (natural log-transformed)|60.81|||||TWO_SIDED|90.0|59.06|62.62|||Schuirmann two one-sided tests procedure||HYLENEX SC/Intravenous|||62.62|59.06|
72487088|NCT00493220|144502670|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence = 90% confidence interval of least squares mean (LSM) within 80%-125%|LSM ratio (%; ln-transformed)|54.4|||||TWO_SIDED|90.0|52.82|56.01|||Schuirmann two one-sided tests procedure||Placebo SC/Intravenous|||56.01|52.82|
72487089|NCT00493220|144502671|SUPERIORITY_OR_OTHER||Median Difference (Net)|-1.0|||<|0.01|TWO_SIDED|90.0|-1.25|-0.75|||Wilcoxon signed-rank test||HYLENEX SC minus Placebo SC|||-0.75|-1.25|<0.01
72487090|NCT00493220|144502671|SUPERIORITY_OR_OTHER||Median Difference (Net)|1.52|||<|0.01|TWO_SIDED|90.0|1.27|1.71|||Wilcoxon signed-rank test||Placebo SC minus Intravenous|||1.71|1.27|<0.01
72487091|NCT00493220|144502671|SUPERIORITY_OR_OTHER||Median Difference (Net)|2.52|||<|0.01|TWO_SIDED|90.0|2.26|2.76|||Wilcoxon signed-rank test||Placebo SC minus Intravenous|||2.76|2.26|<0.01
72487092|NCT00493220|144502672|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence = 90% confidence interval of least squares mean (LSM) within 80%-125%|LSM ratio (%; ln-transformed)|101.99|||||TWO_SIDED|90.0|98.95|105.12|||Schuirmann two one-sided tests procedure||HYLENEX SC/Placebo SC|||105.12|98.95|
72487093|NCT00493220|144502672|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence = 90% confidence interval of least squares mean (LSM) within 80%-125%|LSM ratio (%; ln-transformed)|106.79|||||TWO_SIDED|90.0|103.61|110.07|||Schuirmann two one-sided tests procedure||HYLENEX SC/Intravenous|||110.07|103.61|
72487094|NCT00493220|144502672|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence = 90% confidence interval of least squares mean (LSM) within 80%-125%|LSM ratio (%; ln-transformed)|104.71|||||TWO_SIDED|90.0|101.59|107.92|||Schuirmann two one-sided tests procedure||Placebo SC/Intravenous|||107.92|101.59|
72487095|NCT00493220|144502673|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence = 95% confidence interval of least squares mean (LSM) within 80%-125%|LSM ratio (%; ln-transformed)|101.76|||||TWO_SIDED|90.0|98.64|104.98|||Schuirmann two one-sided tests procedure||HYLENEX SC/Placebo SC|||104.98|98.64|
72577035|NCT00261443|144680751|SUPERIORITY_OR_OTHER_LEGACY|||||||0.253||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Lowest Value of Change in Heart Rate, Phase 3||||0.253
72402905|NCT01480076|144311697|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 9, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the regular activity productivity loss, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
72402906|NCT01480076|144311697|SUPERIORITY_OR_OTHER|||||||0.0937|||||||mixed effect model|||Month 9, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the regular activity productivity loss, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0937
72402907|NCT01480076|144311697|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 9, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the regular activity productivity loss, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
72402908|NCT01480076|144311697|SUPERIORITY_OR_OTHER|||||||0.7814|||||||mixed effect model|||Month 9, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the regular activity productivity loss, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.7814
72402909|NCT01480076|144311697|SUPERIORITY_OR_OTHER||difference of LS means|-3.9|STANDARD_ERROR_OF_MEAN|3.47||0.2561|TWO_SIDED||||||mixed effect model|||Month 9, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the regular activity productivity loss, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.2561
72402910|NCT01480076|144311697|SUPERIORITY_OR_OTHER||difference of LS means|-13.6|STANDARD_ERROR_OF_MEAN|6.07||0.0255|TWO_SIDED||||||mixed effect model|||Month 9, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the regular activity productivity loss, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0255
72402911|NCT01480076|144311697|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 12, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the regular activity productivity loss, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
72402912|NCT01480076|144311697|SUPERIORITY_OR_OTHER|||||||0.7241|||||||mixed effect model|||Month 12, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the regular activity productivity loss, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.7241
72402913|NCT01480076|144311697|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 12, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the regular activity productivity loss, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
72402914|NCT01480076|144311697|SUPERIORITY_OR_OTHER|||||||0.0427|||||||mixed effect model|||Month 12, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the regular activity productivity loss, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0427
72402915|NCT01480076|144311697|SUPERIORITY_OR_OTHER||difference of LS means|-7.2|STANDARD_ERROR_OF_MEAN|3.67||0.0498|TWO_SIDED||||||mixed effect model|||Month 12, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the regular activity productivity loss, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0498
72487096|NCT00493220|144502673|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence = 90% confidence interval of least squares mean (LSM) within 80%-125%|LSM ratio (%; ln-transformed)|106.95|||||TWO_SIDED|90.0|103.67|110.33|||Schuirmann two one-sided tests procedure||HYLENEX SC/Intravenous|||110.33|103.67|
72487097|NCT00493220|144502673|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence = 90% confidence interval of least squares mean (LSM) within 80%-125%|LSM ratio (%; ln-transformed)|105.1|||||TWO_SIDED|90.0|101.87|108.42|||Schuirmann two one-sided tests procedure||Placebo SC/Intravenous|||108.42|101.87|
72487098|NCT02426476|144502676|SUPERIORITY||||||<|0.01||||||Group by Time interaction|Mixed Models Analysis|||Linear mixed models for repeated measures (PROC MIXED in SAS) were used to assess the effects of intervention group, time, and the group by time interaction. A directional (one-sided) hypothesis was tested for the Group-by-Time interaction. The covariance matrix that minimized the Akaike Information Criterion was used. Each outcome was evaluated separately. Models were adjusted for baseline depression score and race.||||<0.01
72487099|NCT02426476|144502677|SUPERIORITY|||||||0.87||||||Group by Time interaction|Mixed Models Analysis|||||||0.87
72514035|NCT03006471|144558886|SUPERIORITY|||||||0.754||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values in dapagliflozin group||||0.754
72402916|NCT01480076|144311697|SUPERIORITY_OR_OTHER||difference of LS means|0.7|STANDARD_ERROR_OF_MEAN|5.95||0.9078|TWO_SIDED||||||mixed effect model|||Month 12, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the regular activity productivity loss, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.9078
72402917|NCT02016482|144311734|SUPERIORITY_OR_OTHER||Difference in percentage|43.2|||<|0.001|TWO_SIDED|95.0|32.8|53.6||Cochran-Mantel-Haenszel test adjusted for strata. If zero frequency occurred, strata were dropped and p-value was calculated based on chi-square test (or adjusted chi-square test based on Campbell \[2007\]).|Cochran-Mantel-Haenszel|||For US regulatory purposes, ranked first secondary endpoint.||53.6|32.8|< 0.001
72402918|NCT02016482|144311735|SUPERIORITY_OR_OTHER||Difference in percentage|42.0|||<|0.001|TWO_SIDED|95.0|30.8|53.2||Cochran-Mantel-Haenszel test adjusted for strata. If zero frequency occurred, strata were dropped and p-value was calculated based on chi-square test (or adjusted chi-square test based on Campbell \[2007\]).|Cochran-Mantel-Haenszel|||Ranked sixth secondary endpoint. For US regulatory purposes, this was the primary endpoint.||53.2|30.8|< 0.001
72402919|NCT02016482|144311736|SUPERIORITY_OR_OTHER||LS Mean|-44.8|||<|0.001|TWO_SIDED|95.0|-53.5|-36.0||P values were calculated from ANCOVA with treatment center stratum, Baseline value, and treatment in the model.|ANCOVA|||Ranked first secondary endpoint. For US regulatory purposes, ranked second secondary endpoint.||-36.0|-53.5|< 0.001
72402920|NCT02016482|144311737|SUPERIORITY_OR_OTHER||Difference in percentage|6.6||||0.008|TWO_SIDED|95.0|1.8|11.3||Cochran-Mantel-Haenszel test adjusted for strata. If zero frequency occurred, strata were dropped and p-value was calculated based on chi-square test (or adjusted chi-square test based on Campbell \[2007\]).|Cochran-Mantel-Haenszel|||Ranked second secondary endpoint. For US regulatory purposes, ranked third secondary endpoint.||11.3|1.8|0.008
72487100|NCT02426476|144502678|SUPERIORITY||||||<|0.01||||||Group by Time Interaction|Mixed Models Analysis|||Linear mixed models for repeated measures (PROC MIXED in SAS) were used to assess the effects of intervention group, time, and the group by time interaction. A directional (one-sided) hypothesis was tested for the Group-by-Time interaction. The covariance matrix that minimized the Akaike Information Criterion was used. Each outcome was evaluated separately. Models were adjusted for baseline depression score and race.||||<0.01
72487101|NCT02414399|144502707|SUPERIORITY||Hazard Ratio (HR)|0.91||||0.58|TWO_SIDED|95.0|0.64|1.29||Alpha =0.045 (to account for .005 alpha spending at interim analysis)|Regression, Cox||azithromycin is the numerator and placebo is the denominator|Death or rehospitalization||1.29|.64|0.58
72487102|NCT02414399|144502707|SUPERIORITY||Hazard Ratio (HR)|0.79||||0.49|TWO_SIDED|95.0|0.39|1.58|||Regression, Cox||Azithromycin-numerator and placebo-denominator|Death alone||1.58|0.39|0.49
72487103|NCT02414399|144502707|SUPERIORITY||Hazard Ratio (HR)|1.01||||0.94|TWO_SIDED|95.0|0.7|1.47|||Regression, Cox||numerator-azithromycin denominator-placebo|Rehospitalization alone||1.47|.70|.94
72487104|NCT02414399|144502715|SUPERIORITY|We modelled azithromycin resistance in E coli at baseline, 3 months, and 6 months of follow-up by randomisation group using generalised estimating equations with a Poisson link and exchangeable correlation structure, including site in the model. Models included an interaction term between randomisation group and follow-up timepoint (month 3 or month 6) to test whether an effect on resistance waned with time.||||||0.77|||||||Chi-squared|||M0||||0.77
72514036|NCT03006471|144558887|SUPERIORITY|||||||0.507||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values in placebo group||||0.507
72514037|NCT03006471|144558887|SUPERIORITY|||||||0.015||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values in dapagliflozin group||||0.015
72514038|NCT03006471|144558888|SUPERIORITY|||||||0.039||||||The threshold for statistical significance was p=0.05|Fisher Exact|||Results showed in this section are the result of the differences between intervention groups||||0.039
72487105|NCT02414399|144502715|SUPERIORITY|We modelled azithromycin resistance in E coli at baseline, 3 months, and 6 months of follow-up by randomisation group using generalised estimating equations with a Poisson link and exchangeable correlation structure, including site in the model. Models included an interaction term between randomisation group and follow-up timepoint (month 3 or month 6) to test whether an effect on resistance waned with time.||||||0.088|||||||Chi-squared|||Month 3||||0.088
72487106|NCT02414399|144502715|SUPERIORITY|We modelled azithromycin resistance in E coli at baseline, 3 months, and 6 months of follow-up by randomisation group using generalised estimating equations with a Poisson link and exchangeable correlation structure, including site in the model. Models included an interaction term between randomisation group and follow-up timepoint (month 3 or month 6) to test whether an effect on resistance waned with time.||||||0.44|||||||Chi-squared|||M6||||0.44
72487107|NCT01704287|144502719|SUPERIORITY_OR_OTHER_LEGACY|Cox regression model with treatment as covariate stratified by Eastern Cooperative Oncology Group (ECOG) performance status (0 vs. 1); lactate dehydrogenase (LDH) levels (normal vs. elevated LDH levels \[≥110% Upper Limit of Normal (ULN)\]); \& BRAF mutational status (mutant vs. wild-type)|Hazard Ratio (HR)|0.58|||<|0.0001|TWO_SIDED|95.0|0.46|0.73||One-sided p-value based on stratified log rank test|Log Rank||Numerator=Pembrolizumab 2 mg/kg Denominator=ICC|||0.73|0.46|<0.0001
72402921|NCT02016482|144311738|SUPERIORITY_OR_OTHER||LS Mean Percent Change|-2.6|||<|0.001|TWO_SIDED|95.0|-3.3|-2.0||P values were calculated from ANCOVA with treatment center stratum, Baseline value, and treatment in the model.|ANCOVA|||Ranked third secondary endpoint. For US regulatory purposes, ranked fourth secondary endpoint.||-2.0|-3.3|< 0.001
72514039|NCT03006471|144558889|SUPERIORITY|||||||0.011|||||||Fisher Exact|||Results showed in this section are the result of the differences between intervention groups||||0.011
72402922|NCT02016482|144311739|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.9|||<|0.001|TWO_SIDED|95.0|-3.6|-2.2||P values were calculated from ANCOVA with treatment center stratum, Baseline value, and treatment in the model.|ANCOVA|||Ranked fourth secondary endpoint. For US regulatory purposes, ranked fifth secondary endpoint.||-2.2|-3.6|< 0.001
72514040|NCT03006471|144558890|SUPERIORITY|||||||0.096||||||The threshold for statistical significance was p=0.05|Fisher Exact|||Results showed in this section are the result of the differences between intervention groups||||0.096
72402923|NCT02016482|144311740|SUPERIORITY_OR_OTHER||Difference in percentage|57.9||||0.002|TWO_SIDED|95.0|33.8|82.0||Cochran-Mantel-Haenszel test adjusted for strata. If zero frequency occurred, strata were dropped and p-value was calculated based on chi-square test (or adjusted chi-square test based on Campbell \[2007\]).|Cochran-Mantel-Haenszel|||Ranked fifth secondary endpoint. For US regulatory purposes, ranked sixth secondary endpoint.||82.0|33.8|0.002
72402924|NCT02016482|144311741|SUPERIORITY_OR_OTHER||Difference in percentage|43.3|||<|0.001|TWO_SIDED|95.0|31.3|55.2||Cochran-Mantel-Haenszel test adjusted for strata. If zero frequency occurred, strata were dropped and p-value was calculated based on chi-square test (or adjusted chi-square test based on Campbell \[2007\]).|Cochran-Mantel-Haenszel|||||55.2|31.3|< 0.001
72402925|NCT02016482|144311742|SUPERIORITY_OR_OTHER||Difference in percentage|44.8|||<|0.001|TWO_SIDED|95.0|33.2|56.5||Cochran-Mantel-Haenszel test adjusted for strata. If zero frequency occurred, strata were dropped and p-value was calculated based on chi-square test (or adjusted chi-square test based on Campbell \[2007\]).|Cochran-Mantel-Haenszel|||||56.5|33.2|< 0.001
72402926|NCT02016482|144311743|SUPERIORITY_OR_OTHER||Difference in percentage|18.6|||<|0.001|TWO_SIDED|95.0|10.6|26.6||Cochran-Mantel-Haenszel test adjusted for strata. If zero frequency occurred, strata were dropped and p-value was calculated based on chi-square test (or adjusted chi-square test based on Campbell \[2007\]).|Cochran-Mantel-Haenszel|||||26.6|10.6|< 0.001
72402927|NCT02016482|144311744|SUPERIORITY_OR_OTHER||Difference in percentage|36.0|||<|0.001|TWO_SIDED|95.0|25.0|46.9||Cochran-Mantel-Haenszel test adjusted for strata. If zero frequency occurred, strata were dropped and p-value was calculated based on chi-square test (or adjusted chi-square test based on Campbell \[2007\]).|Cochran-Mantel-Haenszel|||||46.9|25.0|< 0.001
72514041|NCT03162055|144558929|NON_INFERIORITY|Non-inferiority p-value is calculated corresponding to the non-inferiority margin -50 mL.|Least Square Mean Difference|-87.2|STANDARD_ERROR_OF_MEAN|13.3||0.9974|TWO_SIDED|97.5|-117.0|-57.4|||Repeated measures analysis|Change from baseline = Treatment + baseline FEV1 + BR a/s MDI + stratification factor (prior treatment) + region + visit + treatment by visit.|Estimate of the mean change from baseline over 24 weeks in the GFF treatment group is compared to the UV treatment group using a repeated measures analysis.|||-57.4|-117.0|0.9974
72514042|NCT03162055|144558930|NON_INFERIORITY|Non-inferiority p-value is calculated corresponding to the non-inferiority margin -50 mL.|Least Square Mean Difference|-3.4|STANDARD_ERROR_OF_MEAN|13.1||0.0002|TWO_SIDED|97.5|-32.8|25.9|||Repeated measures analysis|Change from baseline = Treatment + baseline FEV1 + BR a/s MDI + stratification factor (prior treatment) + region + visit + treatment by visit.|Estimate of the mean peak change from baseline over 24 weeks in the GFF treatment group is compared to the UV treatment group using a repeated measures analysis.|||25.9|-32.8|0.0002
72402928|NCT02016482|144311745|SUPERIORITY_OR_OTHER||Difference in percentage|13.3|||<|0.001|TWO_SIDED|95.0|6.5|20.0||Cochran-Mantel-Haenszel test adjusted for strata. If zero frequency occurred, strata were dropped and p-value was calculated based on chi-square test (or adjusted chi-square test based on Campbell \[2007\]).|Cochran-Mantel-Haenszel|||||20.0|6.5|<0.001
72402929|NCT02016482|144311746|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.5|||<|0.001|TWO_SIDED|95.0|-4.3|-2.8||Across all strata, P values were calculated from ANCOVA with treatment center stratum, Baseline value, and treatment in the model.|ANCOVA|||||-2.8|-4.3|< 0.001
72402930|NCT02016482|144311747|SUPERIORITY_OR_OTHER||LS Mean Difference|-38.9|||<|0.001|TWO_SIDED|95.0|-46.9|-30.8||Across all strata, P values were calculated from ANCOVA with treatment center stratum, Baseline value, and treatment in the model.|ANCOVA|||||-30.8|-46.9|< 0.001
72402931|NCT02016482|144311748|SUPERIORITY_OR_OTHER||LS Mean Difference|-28.6|||<|0.001|TWO_SIDED|95.0|-33.5|-23.7||Across all strata, P values were calculated from ANCOVA with treatment center stratum, Baseline value, and treatment in the model.|ANCOVA|||||-23.7|-33.5|< 0.001
72402932|NCT02016482|144311749|SUPERIORITY_OR_OTHER||LS Mean Difference|-50.1|||<|0.001|TWO_SIDED|95.0|-58.3|-41.9||Across all strata, P values were calculated from ANCOVA with treatment center stratum, Baseline value, and treatment in the model.|ANCOVA|||||-41.9|-58.3|< 0.001
72402933|NCT02016482|144311750|SUPERIORITY_OR_OTHER||Difference in percentage|7.4||||0.004|TWO_SIDED|95.0|2.4|12.4||Cochran-Mantel-Haenszel test adjusted for strata. If zero frequency occurred, strata were dropped and p-value was calculated based on chi-square test (or adjusted chi-square test based on Campbell \[2007\]).|Cochran-Mantel-Haenszel|||||12.4|2.4|0.004
72514043|NCT03162055|144558931|SUPERIORITY||Odds Ratio (OR)|2.3|||<|0.0001|TWO_SIDED|95.0|1.79|2.95|||Regression, Logistic|ln (1/(1-p))=Treatment+baseline FEV1+BR a/s MDI+stratification factor (prior treatment)+region.p=percentage of participants with increase of \>=100 mL.|Estimate of the log odds of being a responder in the GFF treatment group compared to the UV treatment group using a logistic regression.|||2.95|1.79|<0.0001
72577036|NCT00261443|144680752|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.06||||0.514|TWO_SIDED|95.0|-0.12|0.23||ANOVA model, controlling for treatment and mood stabilizer, is used for baseline. ANCOVA model, controlling for treatment, mood stabilizer, and baseline value, is used for mean change from baseline.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences and p-values are based on the ANOVA/ANCOVA model.||Week 52 LOCF Treatment Difference||0.23|-0.12|0.514
72402934|NCT02016482|144311751|SUPERIORITY_OR_OTHER||Difference in percentage|18.5|||<|0.001|TWO_SIDED|95.0|10.1|26.8||Cochran-Mantel-Haenszel test adjusted for strata. If zero frequency occurred, strata were dropped and p-value was calculated based on chi-square test (or adjusted chi-square test based on Campbell \[2007\]).|Cochran-Mantel-Haenszel|||||26.8|10.1|< 0.001
72402935|NCT02016482|144311752|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.5|||<|0.001|TWO_SIDED|95.0|-3.1|-1.9||Across all strata, P values were calculated from ANCOVA with treatment center stratum, Baseline value, and treatment in the model.|ANCOVA|||||-1.9|-3.1|< 0.001
72402936|NCT02016482|144311753|SUPERIORITY_OR_OTHER||LS Mean Difference|-40.2|||<|0.001|TWO_SIDED|95.0|-50.0|-30.4||Across all strata, P values were calculated from ANCOVA with treatment center stratum, Baseline value, and treatment in the model.|ANCOVA|||||-30.4|-50.0|< 0.001
72402937|NCT02016482|144311754|SUPERIORITY_OR_OTHER||LS Mean Difference|-19.5|||<|0.001|TWO_SIDED|95.0|-23.6|-15.3||Across all strata, P values were calculated from ANCOVA with stratum, Baseline value, and treatment in the model.|ANCOVA|||||-15.3|-23.6|< 0.001
72402938|NCT02016482|144311755|SUPERIORITY_OR_OTHER||LS Mean Difference|-8.1|||<|0.001|TWO_SIDED|95.0|-10.0|-6.1||Across all strata, P values were calculated from ANCOVA with treatment center stratum, Baseline value, and treatment in the model.|ANCOVA|||||-6.1|-10.0|< 0.001
72624136|NCT01892189|144778533|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3042|STANDARD_ERROR_OF_MEAN|0.20531||0.148|TWO_SIDED|95.0|-0.7214|0.1131|||ANOVA||Difference between least square means of TAK-063 30 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Left Ventrolateral Prefrontal Cortex: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.1131|-0.7214|0.148
72624137|NCT01892189|144778533|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3409|STANDARD_ERROR_OF_MEAN|0.17997||0.067|TWO_SIDED|95.0|-0.7066|0.0249|||ANOVA||Difference between least square means of TAK-063 3 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Right Ventrolateral Prefrontal Cortex: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.0249|-0.7066|0.067
72624138|NCT01892189|144778533|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.0652|STANDARD_ERROR_OF_MEAN|0.19419||0.739|TWO_SIDED|95.0|-0.4599|0.3294|||ANOVA||Difference between least square means of TAK-063 10 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Right Ventrolateral Prefrontal Cortex: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.3294|-0.4599|0.739
72624139|NCT01892189|144778533|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4163|STANDARD_ERROR_OF_MEAN|0.18445||0.031|TWO_SIDED|95.0|-0.7912|-0.0415|||ANOVA||Difference between least square means of TAK-063 30 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Right Ventrolateral Prefrontal Cortex: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||-0.0415|-0.7912|0.031
72624140|NCT01892189|144778533|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2032|STANDARD_ERROR_OF_MEAN|0.14369||0.166|TWO_SIDED|95.0|-0.4952|0.0888|||ANOVA||Difference between least square means of TAK-063 3 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Left Dorsolateral Prefrontal Cortex: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.0888|-0.4952|0.166
72402939|NCT02016482|144311756|SUPERIORITY_OR_OTHER||LS Mean Difference|-71.2|||<|0.001|TWO_SIDED|95.0|-87.3|-55.0||Across all strata, P values were calculated from ANCOVA with treatment center stratum, Baseline value, and treatment in the model.|ANCOVA|||||-55.0|-87.3|< 0.001
72514044|NCT03162055|144558932|NON_INFERIORITY|Non-inferiority p-value is calculated corresponding to the non-inferiority margin -50 mL.|Least Square Mean Difference|-15.2|STANDARD_ERROR_OF_MEAN|19.4||0.0371|TWO_SIDED|95.0|-53.4|22.9|||Repeated measures analysis|Change from baseline = Treatment + baseline IC + BR a/s MDI + stratification factor (prior treatment) + region + visit + treatment by visit.|Estimate of the mean peak change from baseline over 24 weeks in the GFF treatment group is compared to the UV treatment group using a repeated measures analysis.|||22.9|-53.4|0.0371
72514045|NCT03162055|144558933|NON_INFERIORITY|Non-inferiority p-value is calculated corresponding to the non-inferiority margin -1.0 unit.|Least Square Mean Difference|-0.37|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-0.59|-0.14|||Repeated measures analysis|TDI focal score = Treatment + Baseline Dyspnea Index + BR a/s MDI + stratification factor (prior treatment) + region + visit + treatment by visit.|Estimate of the mean TDI focal score over 24 weeks in the GFF treatment group is compared to the UV treatment group using a repeated measures analysis.|||-0.14|-0.59|<0.0001
72514046|NCT03162055|144558934|NON_INFERIORITY|Non-inferiority p-value is calculated corresponding to the non-inferiority margin 0.1 unit.|Least Square Mean Difference|0.034|STANDARD_ERROR_OF_MEAN|0.023||0.0017|TWO_SIDED|95.0|-0.011|0.078|||Repeated measures analysis|Change from baseline = Treatment + baseline EMSCI score + BR a/s MDI + stratification factor (prior treatment) + region + TI + treatment by TI.|Estimate of the mean change from baseline over 24 weeks in the GFF treatment group is compared to the UV treatment group using a repeated measures analysis.|||0.078|-0.011|0.0017
72514047|NCT03162055|144558935|NON_INFERIORITY|Non-inferiority p-value is calculated corresponding to the non-inferiority margin 0.1 unit.|Least Square Mean Difference|0.042|STANDARD_ERROR_OF_MEAN|0.024||0.0088|TWO_SIDED|95.0|-0.005|0.09|||Repeated measures analysis|Change from baseline = Treatment + baseline NiSCI score + BR a/s MDI + stratification factor (prior treatment) + region + TI + treatment by TI.|Estimate of the mean change from baseline over 24 weeks in the GFF treatment group is compared to the UV treatment group using a repeated measures analysis.|||0.090|-0.005|0.0088
72514048|NCT03162055|144558936|SUPERIORITY||Least Square Mean Difference|0.65|STANDARD_ERROR_OF_MEAN|0.2||0.9995|TWO_SIDED|95.0|0.26|1.04|||Repeated measures analysis|Change from baseline =Treatment + baseline rescue a/s MDI use + BR a/s MDI + stratification factor (prior treatment) + region + TI + treatment by TI.|Estimate of the mean change from baseline over 24 weeks in the GFF treatment group is compared to the UV treatment group using a repeated measures analysis.|||1.04|0.26|0.9995
72514049|NCT03162055|144558937|NON_INFERIORITY|Non-inferiority p-value is calculated corresponding to the non-inferiority margin 2.0 unit.|Least Square Mean Difference|0.59|STANDARD_ERROR_OF_MEAN|0.27|<|0.0001|TWO_SIDED|95.0|0.07|1.11|||Repeated measures analysis|Change from baseline = Treatment + baseline CAT score + BR a/s MDI + stratification factor (prior treatment) + region + visit + treatment by visit.|Estimate of the mean change from baseline over 24 weeks in the GFF treatment group is compared to the UV treatment group using a repeated measures analysis.|||1.11|0.07|<0.0001
72514050|NCT03162055|144558938|SUPERIORITY||Least Square Mean Difference|-1.7|STANDARD_ERROR_OF_MEAN|12.8||0.5516|TWO_SIDED|97.5|-30.3|27.0|||Repeated measures analysis|Change from baseline = Treatment + baseline FEV1 + BR a/s MDI + stratification factor (prior treatment) + region + visit + treatment by visit.|Estimate of the mean peak change from baseline over 24 weeks in the GFF treatment group is compared to the UV treatment group using a repeated measures analysis.|||27.0|-30.3|0.5516
72514051|NCT02581865|144558939|SUPERIORITY||Mean Difference (Net)|-1.4|STANDARD_ERROR_OF_MEAN|1.8||0.4326|TWO_SIDED|95.0|-4.9|2.1|||Mixed Models Analysis|||||2.1|-4.9|0.4326
72514052|NCT02581865|144558939|SUPERIORITY||Mean Difference (Net)|-2.5|STANDARD_ERROR_OF_MEAN|1.9||0.1835|TWO_SIDED|95.0|-6.2|1.2|||Mixed Models Analysis|||||1.2|-6.2|0.1835
72624141|NCT01892189|144778533|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0932|STANDARD_ERROR_OF_MEAN|0.15504||0.552|TWO_SIDED|95.0|-0.2219|0.4083|||ANOVA||Difference between least square means of TAK-063 10 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Left Dorsolateral Prefrontal Cortex: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.4083|-0.2219|0.552
72402940|NCT02016482|144311757|SUPERIORITY_OR_OTHER||Difference in percentage|51.1|||<|0.001|TWO_SIDED|95.0|38.6|63.5||Cochran-Mantel-Haenszel test adjusted for strata. If zero frequency occurred, strata were dropped and p-value was calculated based on chi-square test (or adjusted chi-square test based on Campbell \[2007\]).|Cochran-Mantel-Haenszel|||PASI 75||63.5|38.6|< 0.001
72487108|NCT01704287|144502719|SUPERIORITY_OR_OTHER_LEGACY|Cox regression model with treatment as covariate stratified by ECOG performance status (0 vs. 1); LDH levels (normal vs. elevated LDH levels \[≥110% ULN\]); \& BRAF mutational status (mutant vs. wild-type)|Hazard Ratio (HR)|0.47|||<|0.0001|TWO_SIDED|95.0|0.37|0.6||One-sided p-value based on stratified log rank test|Log Rank||Numerator=Pembrolizumab 10 mg/kg Denominator=ICC|||0.60|0.37|<0.0001
72487109|NCT01704287|144502719|SUPERIORITY_OR_OTHER_LEGACY|Cox regression model with treatment as covariate stratified by ECOG performance status (0 vs. 1); LDH levels (normal vs. elevated LDH levels \[≥110% ULN\]); \& BRAF mutational status (mutant vs. wild-type)|Hazard Ratio (HR)|0.83||||0.1247|TWO_SIDED|95.0|0.66|1.05||Two-sided p-value based on stratified log rank test|Log Rank||Numerator=Pembrolizumab 10 mg/kg Denominator=Pembrolizumab 2 mg/kg|||1.05|0.66|0.1247
72487110|NCT01704287|144502720|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.86||||0.1173|TWO_SIDED|95.0|0.67|1.1||One-sided p-value based on stratified log rank test|Log Rank||Numerator=Pembrolizumab 2 mg/kg Denominator=ICC|Cox regression model with treatment as covariate stratified by ECOG performance status (0 vs. 1); LDH levels (normal vs. elevated LDH levels \[≥110% ULN\]); \& BRAF mutational status (mutant vs. wild-type)||1.10|0.67|0.1173
72487111|NCT01704287|144502720|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.74||||0.0106|TWO_SIDED|95.0|0.57|0.96||One-sided p-value based on stratified log rank test|Log Rank||Numerator=Pembrolizumab 10 mg/kg Denominator=ICC|Cox regression model with treatment as covariate stratified by ECOG performance status (0 vs. 1); LDH levels (normal vs. elevated LDH levels \[≥110% ULN\]); \& BRAF mutational status (mutant vs. wild-type)||0.96|0.57|0.0106
72487112|NCT01704287|144502720|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.87||||0.2905|TWO_SIDED|95.0|0.67|1.12||Two-sided p-value based on stratified log rank test|Log Rank||Numerator=Pembrolizumab 10 mg/kg Denominator=Pembrolizumab 2 mg/kg|Cox regression model with treatment as covariate stratified by ECOG performance status (0 vs. 1); LDH levels (normal vs. elevated LDH levels \[≥110% ULN\]); \& BRAF mutational status (mutant vs. wild-type)||1.12|0.67|0.2905
72487113|NCT01704287|144502721|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.86||||0.1146|TWO_SIDED|95.0|0.68|1.1||One-sided p-value based on stratified log rank test|Log Rank||Numerator=Pembrolizumab 2 mg/kg Denominator=ICC|Cox regression model with treatment as covariate stratified by ECOG performance status (0 vs. 1); LDH levels (normal vs. elevated LDH levels \[≥110% ULN\]); \& BRAF mutational status (mutant vs. wild-type)||1.10|0.68|0.1146
72487114|NCT01704287|144502721|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.71||||0.0023|TWO_SIDED|95.0|0.55|0.9||One-sided p-value based on stratified log rank test|Log Rank||Numerator=Pembrolizumab 10 mg/kg Denominator=ICC|Cox regression model with treatment as covariate stratified by ECOG performance status (0 vs. 1); LDH levels (normal vs. elevated LDH levels \[≥110% ULN\]); \& BRAF mutational status (mutant vs. wild-type)||0.90|0.55|0.0023
72487115|NCT01704287|144502721|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.84||||0.149|TWO_SIDED|95.0|0.66|1.07||Two-sided p-value based on stratified log rank test|Log Rank||Numerator=Pembrolizumab 10 mg/kg Denominator=Pembrolizumab 2 mg/kg|Cox regression model with treatment as covariate stratified by ECOG performance status (0 vs. 1); LDH levels (normal vs. elevated LDH levels \[≥110% ULN\]); \& BRAF mutational status (mutant vs. wild-type)||1.07|0.66|0.1490
72487116|NCT01704287|144502722|SUPERIORITY_OR_OTHER_LEGACY|PD-L1-Positive Participants|Hazard Ratio (HR)|0.92||||0.3113|TWO_SIDED|95.0|0.66|1.28||One-sided p-value based on stratified log rank test|Log Rank||Numerator=Pembrolizumab 2 mg/kg Denominator=ICC|Cox regression model with treatment as covariate stratified by ECOG performance status (0 vs. 1); LDH levels (normal vs. elevated LDH levels \[≥110% ULN\]); \& BRAF mutational status (mutant vs. wild-type)||1.28|0.66|0.3113
72487117|NCT01704287|144502722|SUPERIORITY_OR_OTHER_LEGACY|PD-L1 Positive Participants|Hazard Ratio (HR)|0.7||||0.0208|TWO_SIDED|95.0|0.5|0.99||One-sided p-value based on stratified log rank test|Log Rank||Numerator=Pembrolizumab 10 mg/kg Denominator=ICC|Cox regression model with treatment as covariate stratified by ECOG performance status (0 vs. 1); LDH levels (normal vs. elevated LDH levels \[≥110% ULN\]); \& BRAF mutational status (mutant vs. wild-type)||0.99|0.50|0.0208
72487118|NCT01704287|144502722|SUPERIORITY_OR_OTHER_LEGACY|PD-L1 Positive Participants|Hazard Ratio (HR)|0.71||||0.0496|TWO_SIDED|95.0|0.5|1.0||Two-sided p-value based on stratified log rank test|Log Rank||Numerator=Pembrolizumab 10 mg/kg Denominator=Pembrolizumab 2 mg/kg|Cox regression model with treatment as covariate stratified by ECOG performance status (0 vs. 1); LDH levels (normal vs. elevated LDH levels \[≥110% ULN\]); \& BRAF mutational status (mutant vs. wild-type)||1.00|0.50|0.0496
72487119|NCT01704287|144502722|SUPERIORITY_OR_OTHER_LEGACY|PD-L1 Negative Participants|Hazard Ratio (HR)|1.07||||0.6043|TWO_SIDED|95.0|0.65|1.76||One-sided p-value based on stratified log rank test|Log Rank||Numerator=Pembrolizumab 2 mg/kg Denominator=ICC|Cox regression model with treatment as covariate stratified by ECOG performance status (0 vs. 1); LDH levels (normal vs. elevated LDH levels \[≥110% ULN\]); \& BRAF mutational status (mutant vs. wild-type)||1.76|0.65|0.6043
72487120|NCT01704287|144502722|SUPERIORITY_OR_OTHER_LEGACY|PD-L1 Negative Participants|Hazard Ratio (HR)|0.62||||0.0335|TWO_SIDED|95.0|0.37|1.04||One-sided p-value based on stratified log rank test|Log Rank||Numerator=Pembrolizumab 10 mg/kg Denominator=ICC|Cox regression model with treatment as covariate stratified by ECOG performance status (0 vs. 1); LDH levels (normal vs. elevated LDH levels \[≥110% ULN\]); \& BRAF mutational status (mutant vs. wild-type)||1.04|0.37|0.0335
72487121|NCT01704287|144502722|SUPERIORITY_OR_OTHER_LEGACY|PD-L1 Negative Participants|Hazard Ratio (HR)|0.71||||0.1504|TWO_SIDED|95.0|0.44|1.13||Two-sided p-value based on stratified log rank test|Log Rank||Numerator=Pembrolizumab 10 mg/kg Denominator=Pembrolizumab 2 mg/kg|Cox regression model with treatment as covariate stratified by ECOG performance status (0 vs. 1); LDH levels (normal vs. elevated LDH levels \[≥110% ULN\]); \& BRAF mutational status (mutant vs. wild-type)||1.13|0.44|0.1504
72577037|NCT00261443|144680752|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.12||||0.362|TWO_SIDED|95.0|-0.14|0.38||ANOVA model, controlling for treatment and mood stabilizer, is used for baseline. ANCOVA model, controlling for treatment, mood stabilizer, and baseline value, is used for mean change from baseline.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences and p-values are based on the ANOVA/ANCOVA model.||Highest Value of Change Treatment Difference||0.38|-0.14|0.362
72402941|NCT02016482|144311757|SUPERIORITY_OR_OTHER||Difference in percentage|52.5|||<|0.001|TWO_SIDED|95.0|39.9|65.0||Cochran-Mantel-Haenszel test adjusted for strata. If zero frequency occurred, strata were dropped and p-value was calculated based on chi-square test (or adjusted chi-square test based on Campbell \[2007\]).|Cochran-Mantel-Haenszel|||PASI 50||65.0|39.9|< 0.001
72487122|NCT04024228|144502729|SUPERIORITY|Superiority of GMTs was concluded if the lower limit of the 2-sided 95% Confidence Interval (CI) for the ratio of GMTs was above 1 between groups for each of the comparisons.|GMT ratio|1.9|||||TWO_SIDED|95.0|1.58|2.28||||||A/H1N1: 60-64 years||2.28|1.58|
72487123|NCT04024228|144502729|SUPERIORITY|Superiority of GMTs was concluded if the lower limit of the 2-sided 95% CI for the ratio of GMTs was above 1 between groups for each of the comparisons.|GMT ratio|1.7|||||TWO_SIDED|95.0|1.38|2.08||||||A/H3N2: 60-64 years||2.08|1.38|
72487124|NCT04024228|144502729|SUPERIORITY|Superiority of GMTs was concluded if the lower limit of the 2-sided 95% CI for the ratio of GMTs was above 1 between groups for each of the comparisons.|GMT ratio|1.51|||||TWO_SIDED|95.0|1.3|1.74||||||B1: 60-64 years||1.74|1.30|
72487125|NCT04024228|144502729|SUPERIORITY|Superiority of GMTs was concluded if the lower limit of the 2-sided 95% CI for the ratio of GMTs was above 1 between groups for each of the comparisons.|GMT ratio|1.77|||||TWO_SIDED|95.0|1.53|2.04||||||B2: 60-64 years||2.04|1.53|
72487126|NCT04024228|144502729|SUPERIORITY|Superiority of GMTs was concluded if the lower limit of the 2-sided 95% CI for the ratio of GMTs was above 1 between groups for each of the comparisons.|GMT ratio|1.76|||||TWO_SIDED|95.0|1.44|2.15||||||A/H1N1: \>=65 years||2.15|1.44|
72487127|NCT04024228|144502729|SUPERIORITY|Superiority of GMTs was concluded if the lower limit of the 2-sided 95% CI for the ratio of GMTs was above 1 between groups for each of the comparisons.|GMT ratio|2.15|||||TWO_SIDED|95.0|1.74|2.65||||||A/H3N2: \>=65 years||2.65|1.74|
72487128|NCT04024228|144502729|SUPERIORITY|Superiority of GMTs was concluded if the lower limit of the 2-sided 95% CI for the ratio of GMTs was above 1 between groups for each of the comparisons.|GMT ratio|1.55|||||TWO_SIDED|95.0|1.34|1.79||||||B1: \>=65 years||1.79|1.34|
72487129|NCT04024228|144502729|SUPERIORITY|Superiority of GMTs was concluded if the lower limit of the 2-sided 95% CI for the ratio of GMTs was above 1 between groups for each of the comparisons.|GMT ratio|1.76|||||TWO_SIDED|95.0|1.52|2.03||||||B2: \>=65 years||2.03|1.52|
72487130|NCT00938717|144502743|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.65|||<|0.0001|TWO_SIDED|95.0|2.44|8.84||The p-value is still less than 0.05 after adjusting multiplicity using a serial gatekeeping multiple comparison procedure.|Cochran-Mantel-Haenszel|||Null Hypothesis: There is no difference between the 290 μg dose and placebo groups in the proportion of 9/12 Week APC 3 + 1 Responders. The power, adjusted for multiplicity, was expected to be 93% based on NCT00460811 (MCP-103-202) study data.||8.84|2.44|<0.0001
72487131|NCT00938717|144502744|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.19|||<|0.0001|TWO_SIDED|95.0|2.5|7.03||The p-value is still less than 0.05 after adjusting multiplicity using a serial gatekeeping multiple comparison procedure.|Cochran-Mantel-Haenszel|||Null Hypothesis: There is no difference between the 290 μg dose and placebo groups in the proportion of 9/12 Week CSBM 3 + 1 Responders. The power, adjusted for multiplicity, was expected to be 93% based on NCT00460811 (MCP-103-202) study data.||7.03|2.50|<0.0001
72514053|NCT02581865|144558940|SUPERIORITY||Mean Difference (Net)|-0.2|STANDARD_ERROR_OF_MEAN|0.2||0.3812|TWO_SIDED|95.0|-0.7|0.3|||ANOVA|||||0.3|-0.7|0.3812
72514054|NCT02581865|144558940|SUPERIORITY||Mean Difference (Net)|-0.7|STANDARD_ERROR_OF_MEAN|0.3||0.0146|TWO_SIDED|95.0|-1.2|-0.1|||ANOVA|||||-0.1|-1.2|0.0146
72514055|NCT02581865|144558941|SUPERIORITY||Mean Difference (Net)|-0.2|STANDARD_ERROR_OF_MEAN|0.2||0.3065|TWO_SIDED|95.0|-0.6|0.2|||Mixed Models Analysis|||||0.2|-0.6|0.3065
72402942|NCT02016482|144311757|SUPERIORITY_OR_OTHER||Difference in percentage|40.9|||<|0.001|TWO_SIDED|95.0|29.0|52.9||Cochran-Mantel-Haenszel test adjusted for strata. If zero frequency occurred, strata were dropped and p-value was calculated based on chi-square test (or adjusted chi-square test based on Campbell \[2007\]).|Cochran-Mantel-Haenszel|||PASI 90||52.9|29.0|< 0.001
72402943|NCT02016482|144311757|SUPERIORITY_OR_OTHER||Difference in percentage|26.4|||<|0.001|TWO_SIDED|95.0|15.8|36.9||Cochran-Mantel-Haenszel test adjusted for strata. If zero frequency occurred, strata were dropped and p-value was calculated based on chi-square test (or adjusted chi-square test based on Campbell \[2007\]).|Cochran-Mantel-Haenszel|||PASI 100||36.9|15.8|< 0.001
72487132|NCT00938717|144502745|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.62|||<|0.0001|TWO_SIDED|95.0|1.91|3.6||The p-value is still less than 0.05 after adjusting multiplicity using a serial gatekeeping multiple comparison procedure.|Cochran-Mantel-Haenszel|||Null Hypothesis: There is no difference between the 290 μg dose and placebo groups in the proportion of 9/12 Week Abdominal Pain Responders. The power, adjusted for multiplicity, was expected to be 93% based on NCT00460811 (MCP-103-202) study data.||3.60|1.91|<0.0001
72487133|NCT00938717|144502746|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.16|||<|0.0001|TWO_SIDED|95.0|2.22|4.49||The p-value is still less than 0.05 after adjusting multiplicity using a serial gatekeeping multiple comparison procedure.|Cochran-Mantel-Haenszel|||"Null Hypothesis: There is no difference between the 290 μg dose and placebo groups in the proportion of 6/12 Week APC + 1 Responders.~The power, adjusted for multiplicity, was expected to be 86% based on NCT00460811 (MCP-103-202) study data."||4.49|2.22|<0.0001
72487134|NCT01462435|144502765|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|446.946|STANDARD_ERROR_OF_MEAN|122.2935|<|0.001|TWO_SIDED|95.0|206.567|687.324|||ANCOVA|||||687.324|206.567|<0.001
72514056|NCT02581865|144558941|SUPERIORITY||Mean Difference (Net)|-0.3|STANDARD_ERROR_OF_MEAN|0.2||0.2052|TWO_SIDED|95.0|-0.7|0.2|||Mixed Models Analysis|||||0.2|-0.7|0.2052
72514057|NCT02581865|144558942|SUPERIORITY||Mean Difference (Net)|-1.0|STANDARD_ERROR_OF_MEAN|0.8||0.2215|TWO_SIDED|95.0|-2.7|0.6|||ANCOVA|||||0.6|-2.7|0.2215
72514058|NCT02581865|144558942|SUPERIORITY||Mean Difference (Net)|-1.6|STANDARD_ERROR_OF_MEAN|0.9||0.0566|TWO_SIDED|95.0|-3.3|0.0|||ANCOVA|||||0.0|-3.3|0.0566
72514059|NCT02581865|144558943|SUPERIORITY||Mean Difference (Net)|-2.2|STANDARD_ERROR_OF_MEAN|3.8||0.5689|TWO_SIDED|95.0|-9.8|5.4|||Mixed Models Analysis|||||5.4|-9.8|0.5689
72514060|NCT02581865|144558943|SUPERIORITY||Mean Difference (Net)|-4.8|STANDARD_ERROR_OF_MEAN|4.0||0.232|TWO_SIDED|95.0|-12.8|3.1|||Mixed Models Analysis|||||3.1|-12.8|0.2320
72402944|NCT02016482|144311758|SUPERIORITY_OR_OTHER||Difference in percentage|52.2|||<|0.001|TWO_SIDED|95.0|40.8|63.7||Cochran-Mantel-Haenszel test adjusted for strata. If zero frequency occurred, strata were dropped and p-value was calculated based on chi-square test (or adjusted chi-square test based on Campbell \[2007\]).|Cochran-Mantel-Haenszel|||||63.7|40.8|< 0.001
72402945|NCT02016482|144311759|SUPERIORITY_OR_OTHER||Difference in percentage|24.8|||<|0.001|TWO_SIDED|95.0|15.3|34.3||Cochran-Mantel-Haenszel test adjusted for strata. If zero frequency occurred, strata were dropped and p-value was calculated based on chi-square test (or adjusted chi-square test based on Campbell \[2007\]).|Cochran-Mantel-Haenszel|||||34.3|15.3|< 0.001
72402946|NCT02016482|144311760|SUPERIORITY_OR_OTHER||Difference in percentage|90.4|||<|0.001|TWO_SIDED|95.0|72.5|108.3||Cochran-Mantel-Haenszel test adjusted for strata. If zero frequency occurred, strata were dropped and p-value was calculated based on chi-square test (or adjusted chi-square test based on Campbell \[2007\]).|Cochran-Mantel-Haenszel|||||108.3|72.5|< 0.001
72402947|NCT02016482|144311761|SUPERIORITY_OR_OTHER||LS Mean Difference|-11.1|||<|0.001|TWO_SIDED|95.0|-13.9|-8.4||Across all strata, P values were calculated from ANCOVA with treatment center stratum, Baseline value, and treatment in the model.|ANCOVA|||||-8.4|-13.9|< 0.001
72402948|NCT02016482|144311762|SUPERIORITY_OR_OTHER||LS Mean Difference|-80.6|||<|0.001|TWO_SIDED|95.0|-97.9|-63.3||Across all strata, P values were calculated from ANCOVA with treatment center stratum, Baseline value, and treatment in the model.|ANCOVA|||||-63.3|-97.9|< 0.001
72402949|NCT02016482|144311763|SUPERIORITY_OR_OTHER||LS Mean Difference|-50.9|||<|0.001|TWO_SIDED|95.0|-64.0|-37.8||Across all strata, P values were calculated from ANCOVA with treatment center stratum, Baseline value, and treatment in the model.|ANCOVA|||||-37.8|-64.0|< 0.001
72402950|NCT02016482|144311764|SUPERIORITY_OR_OTHER||LS Mean Difference|-57.7|||<|0.001|TWO_SIDED|95.0|-73.1|-42.4||Across all strata, P values were calculated from ANCOVA with treatment center stratum, Baseline value, and treatment in the model.|ANCOVA|||||-42.4|-73.1|< 0.001
72402951|NCT02016482|144311765|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.9|||<|0.001|TWO_SIDED|95.0|-1.1|-0.7||Across all strata, P values were calculated from ANCOVA with treatment center stratum, Baseline value, and treatment in the model.|ANCOVA|||||-0.7|-1.1|< 0.001
72487135|NCT01462435|144502765|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|316.145|STANDARD_ERROR_OF_MEAN|121.5971||0.01|TWO_SIDED|95.0|77.136|555.155|||ANCOVA|||||555.155|77.136|0.010
72514061|NCT02581865|144558944|SUPERIORITY||Mean Difference (Net)|-0.8|STANDARD_ERROR_OF_MEAN|1.1||0.4515|TWO_SIDED|95.0|-3.0|1.3|||Mixed Models Analysis|||||1.3|-3.0|0.4515
72402952|NCT02016482|144311766|SUPERIORITY_OR_OTHER||LS Mean Difference|-27.7|||<|0.001|TWO_SIDED|95.0|-33.9|-21.6||Across all strata, P values were calculated from ANCOVA with treatment center stratum, Baseline value, and treatment in the model.|ANCOVA|||||-21.6|-33.9|< 0.001
72402953|NCT02016482|144311767|SUPERIORITY_OR_OTHER||LS Mean Difference|-6.1|||<|0.001|TWO_SIDED|95.0|-7.8|-4.5||Across all strata, P values were calculated from ANCOVA with treatment center stratum, Baseline value, and treatment in the model.|ANCOVA|||||-4.5|-7.8|< 0.001
72402954|NCT02016482|144311768|SUPERIORITY_OR_OTHER||Difference in percentage|15.7|||<|0.001|TWO_SIDED|95.0|7.1|24.3||Cochran-Mantel-Haenszel test adjusted for strata. If zero frequency occurred, strata were dropped and p-value was calculated based on chi-square test (or adjusted chi-square test based on Campbell \[2007\]).|Cochran-Mantel-Haenszel|||DLQI = 0||24.3|7.1|< 0.001
72402955|NCT02016482|144311768|SUPERIORITY_OR_OTHER||Difference in percentage|27.1|||<|0.001|TWO_SIDED|95.0|16.7|37.4||Cochran-Mantel-Haenszel test adjusted for strata. If zero frequency occurred, strata were dropped and p-value was calculated based on chi-square test (or adjusted chi-square test based on Campbell \[2007\]).|Cochran-Mantel-Haenszel|||DLQI = 0/1||37.4|16.7|< 0.001
72402956|NCT02016482|144311769|SUPERIORITY_OR_OTHER||LS Mean Difference|0.7||||0.416|TWO_SIDED|95.0|-1.0|2.5||Across all strata, P values were calculated from ANCOVA with treatment center stratum, Baseline value, and treatment in the model.|ANCOVA|||Absenteeism||2.5|-1.0|0.416
72402957|NCT02016482|144311769|SUPERIORITY_OR_OTHER||LS Mean Difference|-17.3|||<|0.001|TWO_SIDED|95.0|-22.9|-11.6||Across all strata, P values were calculated from ANCOVA with treatment center stratum, Baseline value, and treatment in the model.|ANCOVA|||Presenteeism||-11.6|-22.9|< 0.001
72402958|NCT02016482|144311769|SUPERIORITY_OR_OTHER||LS Mean Difference|-15.2|||<|0.001|TWO_SIDED|95.0|-21.0|-9.3||Across all strata, P values were calculated from ANCOVA with treatment center stratum, Baseline value, and treatment in the model.|ANCOVA|||Overall work impairment||-9.3|-21.0|< 0.001
72487136|NCT01462435|144502765|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|313.119|STANDARD_ERROR_OF_MEAN|122.5676||0.011|TWO_SIDED|95.0|72.202|554.037|||ANCOVA|||||554.037|72.202|0.011
72487137|NCT01462435|144502766|SUPERIORITY_OR_OTHER|||||||0.043||95.0|||||t-test, 2 sided|||||||0.043
72487138|NCT01462435|144502766|SUPERIORITY_OR_OTHER|||||||0.109||95.0|||||t-test, 2 sided|||||||0.109
72487139|NCT01462435|144502766|SUPERIORITY_OR_OTHER|||||||0.183||95.0|||||t-test, 2 sided|||||||0.183
72487140|NCT01462435|144502767|SUPERIORITY_OR_OTHER|||||||0.009||95.0|||||t-test, 2 sided|||||||0.009
72514062|NCT02581865|144558944|SUPERIORITY||Mean Difference (Net)|-0.5|STANDARD_ERROR_OF_MEAN|1.1||0.6289|TWO_SIDED|95.0|-2.8|1.7|||Mixed Models Analysis|||||1.7|-2.8|0.6289
72487141|NCT01462435|144502767|SUPERIORITY_OR_OTHER|||||||0.029||95.0|||||t-test, 2 sided|||||||0.029
72487142|NCT01462435|144502767|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||t-test, 2 sided|||||||0.050
72487143|NCT01462435|144502768|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||||||<0.001
72487144|NCT01462435|144502768|SUPERIORITY_OR_OTHER|||||||0.004||95.0|||||t-test, 2 sided|||||||0.004
72487145|NCT01462435|144502768|SUPERIORITY_OR_OTHER|||||||0.004||95.0|||||t-test, 2 sided|||||||0.004
72487146|NCT01462435|144502769|SUPERIORITY_OR_OTHER|||||||0.009||95.0|||||t-test, 2 sided|||||||0.009
72487147|NCT01462435|144502769|SUPERIORITY_OR_OTHER|||||||0.091||95.0|||||t-test, 2 sided|||||||0.091
72487148|NCT01462435|144502769|SUPERIORITY_OR_OTHER|||||||0.053||95.0|||||t-test, 2 sided|||||||0.053
72487149|NCT01462435|144502770|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||t-test, 2 sided|||||||0.002
72514063|NCT01617655|144558951|SUPERIORITY_OR_OTHER||LS mean difference|-39.1|||<|0.0001|TWO_SIDED|95.0|-51.1|-27.1||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs Placebo|Alirocumab group was compared to placebo group using an appropriate contrast statement.||-27.1|-51.1|<0.0001
72402959|NCT02016482|144311769|SUPERIORITY_OR_OTHER||LS Mean Difference|-21.4|||<|0.001|TWO_SIDED|95.0|-27.3|-15.4||Across all strata, P values were calculated from ANCOVA with treatment center stratum, Baseline value, and treatment in the model.|ANCOVA|||Activity impairment||-15.4|-27.3|< 0.001
72487150|NCT01462435|144502770|SUPERIORITY_OR_OTHER|||||||0.026||95.0|||||t-test, 2 sided|||||||0.026
72487151|NCT01462435|144502770|SUPERIORITY_OR_OTHER|||||||0.017||95.0|||||t-test, 2 sided|||||||0.017
72487152|NCT01462435|144502771|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||||||<0.001
72487153|NCT01462435|144502771|SUPERIORITY_OR_OTHER|||||||0.005||95.0|||||t-test, 2 sided|||||||0.005
72487154|NCT01462435|144502771|SUPERIORITY_OR_OTHER|||||||0.004||95.0|||||t-test, 2 sided|||||||0.004
72487155|NCT01462435|144502772|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||||||<0.001
72487156|NCT01462435|144502772|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||||||<0.001
72487157|NCT01462435|144502772|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||||||<0.001
72487158|NCT02248259|144502781|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Equivalence range was 80% to 125%|Geometric mean ratio (%)|113.6|STANDARD_ERROR_OF_MEAN|1.07|||TWO_SIDED|90.0|100.522|128.376|||||Ratio calculated as extensive metabolisers test treatment divided by extensive metabolisers: ref. treatment|Analysis for BI 409306||128.376|100.522|
72487159|NCT02248259|144502781|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Equivalence range was 80% to 125%|Geometric mean ratio (%)|87.98|STANDARD_ERROR_OF_MEAN|1.07|||TWO_SIDED|90.0|77.839|99.452|||||Ratio calculated as poor metabolisers test treatment divided by poor metabolisers: ref. treatment|Analysis for BI 409306||99.452|77.839|
72514064|NCT01617655|144558952|SUPERIORITY_OR_OTHER||LS mean difference|-38.9|||<|0.0001|TWO_SIDED|95.0|-51.0|-26.9||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs Placebo|A hierarchical testing procedure was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when previous endpoint was statistically significant at 0.05 level.||-26.9|-51|<0.0001
72514065|NCT01617655|144558953|SUPERIORITY_OR_OTHER||LS mean difference|-40.3|||<|0.0001|TWO_SIDED|95.0|-51.4|-29.3||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-29.3|-51.4|<0.0001
72514066|NCT01617655|144558954|SUPERIORITY_OR_OTHER||LS mean difference|-40.3|||<|0.0001|TWO_SIDED|95.0|-51.4|-29.2||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-29.2|-51.4|<0.0001
72567941|NCT02037165|144667469|SUPERIORITY_OR_OTHER||adjusted mean difference|0.71|STANDARD_ERROR_OF_MEAN|1.3652|||TWO_SIDED|95.0|-2.0|3.4|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 4:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||3.4|-2.0|
72514067|NCT01617655|144558955|SUPERIORITY_OR_OTHER||LS mean difference|-30.3|||<|0.0001|TWO_SIDED|95.0|-39.7|-20.9||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-20.9|-39.7|<0.0001
72402960|NCT02016482|144311770|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1|||<|0.001|TWO_SIDED|95.0|0.1|0.2||P values were calculated from ANCOVA with treatment center stratum, Baseline value, and treatment in the model.|ANCOVA|||||0.2|0.1|< 0.001
72487160|NCT02248259|144502781|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Equivalence range was 80% to 125%|Geometric mean ratio (%)|89.21|STANDARD_ERROR_OF_MEAN|1.029|||TWO_SIDED|90.0|84.636|94.021|||||Ratio calculated as extensive metabolisers test treatment divided by extensive metabolisers: ref. treatment|Analysis for CD 13896||94.021|84.636|
72487161|NCT02248259|144502781|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Equivalence range was 80% to 125%|Geometric mean ratio (%)|92.89|STANDARD_ERROR_OF_MEAN|1.026|||TWO_SIDED|90.0|88.592|97.396|||||Ratio calculated as poor metabolisers test treatment divided by poor metabolisers: ref. treatment|Analysis of CD 13896||97.396|88.592|
72487162|NCT02248259|144502781|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Equivalence range was 80% to 125%|Geometric mean ratio (%)|99.61|STANDARD_ERROR_OF_MEAN|1.022|||TWO_SIDED|90.0|95.796|103.584|||||Ratio calculated as extensive metabolisers test treatment divided by extensive metabolisers: ref. treatment|Analysis for CD 14084||103.584|95.796|
72487163|NCT02248259|144502781|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Equivalence range was 80% to 125%|Geometric mean ratio (%)|104.37|STANDARD_ERROR_OF_MEAN|1.031|||TWO_SIDED|90.0|98.783|110.278|||||Ratio calculated as poor metabolisers test treatment divided by poor metabolisers: ref. treatment|Analysis for CD 14084||110.278|98.783|
72487164|NCT02248259|144502782|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Equivalence range was 80% to 125%|Geometric mean ratio (%)|93.26|STANDARD_ERROR_OF_MEAN|1.086|||TWO_SIDED|90.0|80.377|108.217|||||Ratio calculated as extensive metabolisers test treatment divided by extensive metabolisers: ref. treatment|Analysis for BI 409306||108.217|80.377|
72487165|NCT02248259|144502782|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Equivalence range was 80% to 125%|Geometric mean ratio (%)|76.65|STANDARD_ERROR_OF_MEAN|1.14|||TWO_SIDED|90.0|60.482|97.141|||||Ratio calculated as poor metabolisers test treatment divided by poor metabolisers: ref. treatment|Analysis for BI 409306||97.141|60.482|
72487166|NCT02248259|144502782|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Equivalence range was 80% to 125%|Geometric mean ratio (%)|78.71|STANDARD_ERROR_OF_MEAN|1.09|||TWO_SIDED|90.0|67.304|92.052|||||Ratio calculated as extensive metabolisers test treatment divided by extensive metabolisers: ref. treatment|Analysis for CD 13896||92.052|67.304|
72487167|NCT02248259|144502782|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Equivalence range was 80% to 125%|Geometric mean ratio (%)|95.29|STANDARD_ERROR_OF_MEAN|1.093|||TWO_SIDED|90.0|81.092|111.964|||||Ratio calculated as poor metabolisers test treatment divided by poor metabolisers: ref. treatment|Analysis for CD 13896||111.964|81.092|
72402961|NCT02016482|144311771|SUPERIORITY_OR_OTHER||LS Mean Difference|5.5||||0.012|TWO_SIDED|95.0|1.2|9.8||P values were calculated from ANCOVA with treatment center stratum, Baseline value, and treatment in the model.|ANCOVA|||||9.8|1.2|0.012
72402962|NCT02016482|144311772|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.1||||0.025|TWO_SIDED|95.0|-2.0|-0.1||P values were calculated from ANCOVA with treatment center stratum, Baseline value, and treatment in the model.|ANCOVA|||HADS anxiety score||-0.1|-2.0|0.025
72487168|NCT02248259|144502782|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Equivalence range was 80% to 125%|Geometric mean ratio (%)|86.79|STANDARD_ERROR_OF_MEAN|1.041|||TWO_SIDED|90.0|80.731|93.309|||||Ratio calculated as extensive metabolisers test treatment divided by extensive metabolisers: ref. treatment|Analysis for CD 14084||93.309|80.731|
72402963|NCT02016482|144311772|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.3||||0.005|TWO_SIDED|95.0|-2.3|-0.4||P values were calculated from ANCOVA with treatment center stratum, Baseline value, and treatment in the model.|ANCOVA|||HADS depression score||-0.4|-2.3|0.005
72514068|NCT01617655|144558956|SUPERIORITY_OR_OTHER||LS mean difference|-30.2|||<|0.0001|TWO_SIDED|95.0|-39.7|-20.7||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-20.7|-39.7|<0.0001
72514069|NCT01617655|144558957|SUPERIORITY_OR_OTHER||LS mean difference|-35.8|||<|0.0001|TWO_SIDED|95.0|-46.3|-25.3||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-25.3|-46.3|<0.0001
72514070|NCT01617655|144558958|SUPERIORITY_OR_OTHER||LS mean difference|-35.5|||<|0.0001|TWO_SIDED|95.0|-46.2|-24.9||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-24.9|-46.2|<0.0001
72514071|NCT01617655|144558959|SUPERIORITY_OR_OTHER||LS mean difference|-28.4|||<|0.0001|TWO_SIDED|95.0|-37.3|-19.6||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-19.6|-37.3|<0.0001
72514072|NCT01617655|144558960|SUPERIORITY_OR_OTHER||LS mean difference|-30.2|||<|0.0001|TWO_SIDED|95.0|-39.2|-21.1||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-21.1|-39.2|<0.0001
72514073|NCT01617655|144558961|SUPERIORITY_OR_OTHER||LS mean difference|-34.5|||<|0.0001|TWO_SIDED|95.0|-44.8|-24.1||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-24.1|-44.8|<0.0001
72514074|NCT01617655|144558962|SUPERIORITY_OR_OTHER||LS mean difference|-27.8|||<|0.0001|TWO_SIDED|95.0|-36.2|-19.4||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-19.4|-36.2|<0.0001
72514075|NCT01617655|144558963|SUPERIORITY_OR_OTHER||LS mean difference|-39.1|||<|0.0001|TWO_SIDED|95.0|-53.6|-24.6||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-24.6|-53.6|<0.0001
72514076|NCT01617655|144558964|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|11.7||||0.0016|TWO_SIDED|95.0|2.5|53.5||Threshold for significance ≤ 0.05.|Regression, Logistic|Multiple imputation approach followed by logistic regression model.|Alirocumab vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||53.5|2.5|0.0016
72514077|NCT01617655|144558965|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|11.9||||0.0014|TWO_SIDED|95.0|2.6|54.9||Threshold for significance ≤ 0.05.|Regression, Logistic|Multiple imputation approach followed by logistic regression model.|Alirocumab vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||54.9|2.6|0.0014
72514078|NCT01617655|144558966|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-14.8||||0.0164|TWO_SIDED|95.0|-26.9|-2.7||Threshold for significance ≤ 0.05.|Regression, Robust|Multiple imputation approach followed by robust regression model.|Alirocumab vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-2.7|-26.9|0.0164
72514079|NCT01617655|144558967|SUPERIORITY_OR_OTHER||LS mean difference|3.7||||0.2745|TWO_SIDED|95.0|-2.9|10.2||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||10.2|-2.9|0.2745
72514080|NCT03224585|144558979|SUPERIORITY|||||||0.0121|||||||Paired samples Wilcoxon test|||This analysis compared the change in pain scores between baseline and 6 hours||||0.0121
72514081|NCT03224585|144558980|SUPERIORITY|||||||0.0025|||||||Paired samples Wilcoxon test|||||||0.0025
72514082|NCT01175213|144558981|SUPERIORITY_OR_OTHER_LEGACY||Poisson|0.02|||<|0.0001|ONE_SIDED|99.0||0.045||Testing the null hypothesis of 1 VASBI/year against a one-sided alternative at the 0.01 level of statistical significance.|Poisson|||||0.045||<0.0001
72514083|NCT01921634|144559011|SUPERIORITY||Odds Ratio (OR)|1.3||||0.01|TWO_SIDED|95.0|1.1|1.7|||McNemar||The odds ratio was generated from a logistic regression model using generalized estimating equations with a logit link and represents a comparison of modified (numerator) vs standard (denominator).|||1.7|1.1|0.01
72514084|NCT00781963|144559049|SUPERIORITY||Mean Difference (Final Values)|-15.8|STANDARD_ERROR_OF_MEAN|6.6|<|0.001|TWO_SIDED|95.0|-28.7|-3.0|||Mixed Models Analysis||The parameter estimate is the improvement in sleep onset latency from baseline to 6-month follow-up for CBT-I group versus the same improvement in the control group.|||-3.0|-28.7|<.001
72514085|NCT00781963|144559050|SUPERIORITY||Mean Difference (Final Values)|-10.2|STANDARD_ERROR_OF_MEAN|8.2||0.21|TWO_SIDED|95.0|-26.3|5.9|||Mixed Models Analysis||The parameter estimate is the improvement in wake after sleep onset from baseline to 6-month follow-up for CBT-I group versus the same improvement in the control group.|||5.9|-26.3|0.21
72487169|NCT02248259|144502782|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Equivalence range was 80% to 125%|Geometric mean ratio (%)|107.45|STANDARD_ERROR_OF_MEAN|1.091|||TWO_SIDED|90.0|91.764|125.812|||||Ratio calculated as poor metabolisers test treatment divided by poor metabolisers: ref. treatment|Analysis for CD 14084||125.812|91.764|
72402964|NCT02016482|144311773|SUPERIORITY_OR_OTHER||Difference in percentage|2.5||||0.164|TWO_SIDED|95.0|-0.9|6.0||Cochran-Mantel-Haenszel test adjusted for strata. If zero frequency occurred, strata were dropped and p-value was calculated based on chi-square test (or adjusted chi-square test based on Campbell \[2007\]).|Chi-squared|||||6|-0.9|0.164
72402965|NCT02016482|144311774|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.8|||<|0.001|TWO_SIDED|95.0|-3.4|-2.1||P values were calculated from ANCOVA with treatment center stratum, Baseline value, and treatment in the model.|ANCOVA|||||-2.1|-3.4|< 0.001
72402966|NCT03054870|144311775|NON_INFERIORITY|The non-inferiority margin was determined from a separate study where 6 blinded readers read and re-read 75 Xe-133 planar ventilation imaging studies in 2 read sessions separated by a minimum of 4 weeks. The readers scored the 6 regions of the lung using the same ventilation scoring metric used in this study. Based on analysis of the read/re-read results, 60% was established as a suitable margin for establishing the non-inferiority of Technegas compared to Xe-133.|||||<|0.0141||||||P-value is one-sided; for testing non-inferiority the associated critical value for PA is provided by lower bound of the 97.18% confidence interval.|Mixed Models Analysis|Binary agreement scores between Technegas and Xe-133 ventilation scores by subject-lung region served as the dependent variable in the model.||PA between Technegas and Xe-133 from analysis of each of the 3 blinded readers' ventilation scores was subjected to the following test of null (H0) versus alternate hypotheses (HA): H0: PA \<= 60% versus HA: PA \> 60%. The original sample size of 240 subjects was based on 90% power and one-sided alpha=0.025. For the unplanned interim analysis of 200 subjects, testing for non-inferiority used one-sided alpha=0.0141 (critical value provided by lower bound of the 97.18% confidence interval).|Binary agreement scores were analyzed for each reader separately using a generalized linear model with SAS® PROC GENMOD. The logit function (log odds ratio) was specified as the link function, and subject was specified as a repeated measure to allow for correlations between lung regions within a subject. The estimate of the intercept of the model using generalized estimating equation (GEE) methodology provided an overall estimate of the agreement and corresponding confidence interval in terms of the log odds ratio. Simple algebra was used to obtain the corresponding estimates and confidence intervals in terms of percent agreement (PA). For the study to be considered a success, the null hypothesis had to be rejected for at least 2 of the 3 blinded readers for the primary efficacy endpoint.|||<0.0141
72402967|NCT03054870|144311776|NON_INFERIORITY|The non-inferiority margin was determined from a separate study where 6 blinded readers read and re-read 75 Xe-133 planar ventilation imaging studies in 2 read sessions separated by a minimum of 4 weeks. The readers scored the 6 regions of the lung using the same ventilation scoring metric used in this study. Based on analysis of the read/re-read results, 60% was established as a suitable margin for establishing the non-inferiority of Technegas compared to Xe-133.|||||<|0.0141||||||P-value is one-sided; for testing non-inferiority the associated critical value for PA is provided by lower bound of the 97.18% confidence interval.|Mixed Models Analysis|Binary agreement scores between Technegas and Xe-133 ventilation scores by subject-lung region served as the dependent variable in the model.||PA between Technegas and Xe-133 from analysis of each of the 3 blinded readers' ventilation scores was subjected to the following test of null (H0) versus alternate hypotheses (HA): H0: PA \<= 60% versus HA: PA \> 60%. The original sample size of 240 subjects was based on 90% power and one-sided alpha=0.025. For the unplanned interim analysis of 200 subjects, testing for non-inferiority used one-sided alpha=0.0141 (critical value provided by lower bound of the 97.18% confidence interval).|Binary agreement scores were analyzed for each reader separately using a generalized linear model with SAS® PROC GENMOD. The logit function (log odds ratio) was specified as the link function, and subject was specified as a repeated measure to allow for correlations between lung regions within a subject. The estimate of the intercept of the model using generalized estimating equation (GEE) methodology provided an overall estimate of the agreement and corresponding confidence interval in terms of the log odds ratio. Simple algebra was used to obtain the corresponding estimates and confidence intervals in terms of percent agreement (PA). For the study to be considered a success, the null hypothesis had to be rejected for at least 2 of the 3 blinded readers for the primary efficacy endpoint.|||<0.0141
72402968|NCT03054870|144311777|OTHER||||||||||||||||||Estimates of inter-observer percent agreement were obtained as follows. For each reader-pair, binary agreement scores by subject and lung region were analyzed using a generalized linear model with SAS® PROC GENMOD. The logit function (log odds ratio) was specified as the link function, and subject was specified as a repeated measure to allow for correlations between lung regions within a subject. The estimate of the intercept of the model using generalized estimating equation (GEE) methodology provided an overall estimate of the agreement and corresponding confidence interval in terms of the log odds ratio. Simple algebra was used to obtain the corresponding estimates and confidence intervals in terms of percent agreement.|||
72402969|NCT03054870|144311778|OTHER||||||||||||||||||For each pair of readers, by lung region estimates of kappa statistics and their corresponding 95% confidence intervals were generated from cross-tabulation frequencies of the readers' ventilation scores using SAS® PROC FREQ and the AGREE option.|||
72402970|NCT01154218|144311782|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|99.56|||||TWO_SIDED|90.0|91.49|108.33||||||Natural log transformed AUC (0-∞) of crizotinib was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% confidence intervals (CIs) for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||108.33|91.49|
72514086|NCT00781963|144559051|SUPERIORITY||Mean Difference (Final Values)|-37.0|STANDARD_ERROR_OF_MEAN|12.9||0.004|TWO_SIDED|95.0|-62.2|-11.7|||Mixed Models Analysis||The parameter estimate is the improvement in total wake time from baseline to 6-month follow-up for CBT-I group versus the same improvement in the control group.|||-11.7|-62.2|0.004
72514087|NCT00781963|144559052|SUPERIORITY||Mean Difference (Final Values)|6.7|STANDARD_ERROR_OF_MEAN|2.36||0.005|TWO_SIDED|95.0|2.0|11.3|||Mixed Models Analysis||The parameter estimate is the improvement in sleep efficiency from baseline to 6-month follow-up for CBT-I group versus the same improvement in the control group.|||11.3|2.0|.005
72514088|NCT00781963|144559053|SUPERIORITY||Mean Difference (Final Values)|-1.4|STANDARD_ERROR_OF_MEAN|0.97||0.15|TWO_SIDED|95.0|-3.3|0.5|||Mixed Models Analysis||The parameter estimate is the improvement in sleep efficiency (from wrist actigraphy) from baseline to 6-month follow-up for CBT-I group versus the same improvement in the control group.|||0.5|-3.3|0.15
72514089|NCT00781963|144559054|SUPERIORITY||Mean Difference (Final Values)|-2.4|STANDARD_ERROR_OF_MEAN|0.55|<|0.001|TWO_SIDED|95.0|-3.5|-1.3|||Mixed Models Analysis||The parameter estimate is the improvement in PSQI score from baseline to 6-month follow-up for CBT-I group versus the same improvement in the control group.|||-1.3|-3.5|<.001
72514090|NCT00680953|144559055|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.343||||0.0001|TWO_SIDED|95.0|0.194|0.606|||Log Rank|||||0.606|0.194|0.0001
72514091|NCT00680953|144559056|SUPERIORITY_OR_OTHER|||||||0.9951|||||||Log Rank|||||||0.9951
72514092|NCT00680953|144559057|SUPERIORITY_OR_OTHER|||||||0.1568|||||||Log Rank|||||||0.1568
72514093|NCT02064205|144559058|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|18.0|STANDARD_DEVIATION|1000.0||0.2918|ONE_SIDED||||||Mixed Models Analysis|||A mixed model was applied to analyze the Energy Intakes (ad libitum lunch and daily) were done one-sided to evaluate the appetite suppressive effect after the pre-load snack (condition C versus D)||||0.2918
72514094|NCT02064205|144559059|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0109|||||||Mixed Models Analysis|||AUC of hunger scores before preload intake for condition C versus D.||||0.0109
72514095|NCT02064205|144559060|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0216||||||GLP-1|Mixed Models Analysis|||A mixed model was applied to statistically analyze satiety hormones having Conditions and Time as a fixed factor and having Subject, Cohort, and Treatment Day as random factors.||||0.0216
72624142|NCT01892189|144778533|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1648|STANDARD_ERROR_OF_MEAN|0.14727||0.271|TWO_SIDED|95.0|-0.4641|0.1345|||ANOVA||Difference between least square means of TAK-063 30 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Left Dorsolateral Prefrontal Cortex: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.1345|-0.4641|0.271
72514096|NCT03057951|144559061|SUPERIORITY|H0: There is no difference between the effect of placebo and the effect of empagliflozin.|Hazard Ratio (HR)|0.79||||0.0003|TWO_SIDED|95.03|0.69|0.9|||Regression, Cox||Comparison vs. Placebo \[T/P\]|"Cox regression, with terms for treatment, region, baseline status of diabetes, age, sex, left ventricular ejection fraction (LVEF) and glomerular filtration rate estimated by the chronic kidney disease epidemiology collaboration formula with serum creatinine measurement (eGFR (CKD-EPI)cr) at baseline.~alpha=0.0497 (resulting from interim analysis)."||0.90|0.69|0.0003
72514097|NCT03057951|144559062|SUPERIORITY|H0: There is no difference between the effect of placebo and the effect of empagliflozin.|Hazard Ratio (HR)|0.73||||0.0009|TWO_SIDED|95.03|0.61|0.88|||Joint frailty model||Comparison vs. Placebo \[T/P\]|Joint frailty model that accounts for dependence between recurrent HHF and cardiovascular death, with terms for age, baseline eGFR (CKD-EPK)cr, baseline LVEF, region, baseline diabetes status, sex, and treatment. eGFR (CKP-EPI)cr: Glomerular filtration rate estimated by the chronic kidney disease epidemiology collaboration formula with serum creatinine measurement LVEF: Left ventricular ejection fraction. alpha=0.0497 (resulting from interim analysis).||0.88|0.61|0.0009
72514098|NCT03057951|144559063|SUPERIORITY|H0: There is no difference between the effect of placebo and the effect of empagliflozin.|Treatment by time interaction|1.363|||<|0.0001|TWO_SIDED|99.9|0.861|1.865|||Random intercept random coeff. model||Empa 10 mg vs. Placebo slope \[/year\]|"Random coefficient model allowing for random intercept and random slope per patient, with factors age, baseline eGFR (CKD-EPI), baseline LVEF as linear covariate(s) and region, baseline diabetes status, sex, baseline-by-time interaction, treatment-by-time interaction and treatment as fixed effects.~Only 'on-treatment' data from treated patients were used. alpha=0.001. covariance structure: Unstructured."||1.865|0.861|<0.0001
72514099|NCT03057951|144559064|OTHER||Hazard Ratio (HR)|0.95||||0.7243|TWO_SIDED|95.0|0.73|1.24|||Regression, Cox||Comparison vs Placebo \[T/P\]|Cox regression model included terms age, baseline glomerular filtration rate estimated by the chronic kidney disease epidemiology collaboration formula with serum creatinine measurement (eGFR (CKD-EPI)cr), region, baseline diabetes status, sex, baseline Left ventricular ejection fraction (LVEF) and treatment.||1.24|0.73|0.7243
72514100|NCT03057951|144559065|OTHER||Hazard Ratio (HR)|0.71|||<|0.0001|TWO_SIDED|95.0|0.6|0.83|||Regression, Cox||Comparison vs. Placebo \[T/P\]|Cox regression model included terms age, baseline glomerular filtration rate estimated by the chronic kidney disease epidemiology collaboration formula with serum creatinine measurement (eGFR (CKD-EPI)cr), region, baseline diabetes status, sex, baseline Left ventricular ejection fraction (LVEF) and treatment.||0.83|0.60|<0.0001
72514101|NCT03057951|144559066|OTHER||Hazard Ratio (HR)|0.91||||0.2951|TWO_SIDED|95.0|0.76|1.09|||Regression, Cox||Comparison vs. Placebo \[T/P\]|Cox regression model included terms age, baseline glomerular filtration rate estimated by the chronic kidney disease epidemiology collaboration formula with serum creatinine measurement (eGFR (CKD-EPI)cr), region, baseline diabetes status, sex, baseline Left ventricular ejection fraction (LVEF) and treatment.||1.09|0.76|0.2951
72514102|NCT03057951|144559067|OTHER||Hazard Ratio (HR)|1.0||||0.9893|TWO_SIDED|95.0|0.87|1.15|||Regression, Cox||Comparison vs. Placebo \[T/P\]|Cox regression model included terms age, baseline glomerular filtration rate estimated by the chronic kidney disease epidemiology collaboration formula with serum creatinine measurement (eGFR (CKD-EPI)cr), region, baseline diabetes status, sex, baseline Left ventricular ejection fraction (LVEF) and treatment.||1.15|0.87|0.9893
72514103|NCT03057951|144559068|OTHER||Hazard Ratio (HR)|0.84||||0.1539|TWO_SIDED|95.0|0.65|1.07|||Regression, Cox||Comparison vs. Placebo \[T/P\]|Cox regression model included terms age, baseline glomerular filtration rate estimated by the chronic kidney disease epidemiology collaboration formula with serum creatinine measurement (eGFR (CKD-EPI)cr), region, baseline diabetes status, sex, baseline Left ventricular ejection fraction (LVEF) and treatment.||1.07|0.65|0.1539
72514104|NCT03057951|144559069|OTHER||Adjusted mean difference|1.32|STANDARD_ERROR_OF_MEAN|0.44||0.0028|TWO_SIDED|95.0|0.45|2.19|||Mixed Model Repeated Measures (MMRM)||Comparison vs Placebo \[T-P\]|"Model includes age, baseline glomerular filtration rate estimated by the chronic kidney disease epidemiology collaboration formula (eGFR (CKD-EPI)), baseline Left ventricular ejection fraction (LVEF) as linear covariate(s) and region, baseline diabetes status, sex, week reachable, treatment-by-visit interaction, baseline KCCQ-Clinical-Summary-Score-by-visit interaction as fixed effect(s).~Unstructured covariance structure."||2.19|0.45|0.0028
72514105|NCT03057951|144559070|OTHER||Hazard Ratio (HR)|0.93||||0.1012|TWO_SIDED|95.0|0.85|1.01|||Joint frailty model||Comparison vs. Placebo \[T/P\]|Joint frailty model that accounts for the dependence between recurrent all-cause hospitalisation and all-cause mortality was used. Joint frailty model with terms for age, baseline glomerular filtration rate estimated by the chronic kidney disease epidemiology collaboration formula (eGFR (CKD-EPI)), baseline Left ventricular ejection fraction (LVEF), treatment, region, baseline diabetes status and sex.||1.01|0.85|0.1012
72514106|NCT00696436|144559071|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.27|||<|0.001|TWO_SIDED|95.0|-16.54|-12.01||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented. Overall 0.05 level of significance for multiple comparisons was controlled using stepwise testing procedure.|ANCOVA|||||-12.01|-16.54|<0.001
72514107|NCT00696436|144559071|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.16|||<|0.001|TWO_SIDED|95.0|-15.41|-10.91||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented. Overall 0.05 level of significance for multiple comparisons was controlled using stepwise testing procedure.|ANCOVA|||||-10.91|-15.41|<0.001
72624143|NCT01892189|144778533|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2516|STANDARD_ERROR_OF_MEAN|0.16169||0.129|TWO_SIDED|95.0|-0.5802|0.077|||ANOVA||Difference between least square means of TAK-063 3 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Right Dorsolateral Prefrontal Cortex: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.0770|-0.5802|0.129
72402971|NCT01154218|144311782|SUPERIORITY_OR_OTHER||Ratio of Adjusted means|106.93|||||TWO_SIDED|90.0|98.26|116.35||||||Natural log transformed AUC (0-∞) of crizotinib was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||116.35|98.26|
72567942|NCT02037165|144667469|SUPERIORITY_OR_OTHER||adjusted mean difference|0.36|STANDARD_ERROR_OF_MEAN|1.3652|||TWO_SIDED|95.0|-2.3|3.0|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 5:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||3.0|-2.3|
72402972|NCT01154218|144311782|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|85.76|||||TWO_SIDED|90.0|78.88|93.25||||||Natural log transformed AUC (0-∞) of crizotinib was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||93.25|78.88|
72514108|NCT00696436|144559071|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.54||||0.009|TWO_SIDED|95.0|-4.44|-0.64||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented. Overall 0.05 level of significance for multiple comparisons was controlled using stepwise testing procedure.|ANCOVA|||||-0.64|-4.44|0.009
72514109|NCT00696436|144559071|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.31|||<|0.001|TWO_SIDED|95.0|-6.25|-2.37||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented. Overall 0.05 level of significance for multiple comparisons was controlled using stepwise testing procedure.|ANCOVA|||||-2.37|-6.25|<0.001
72514110|NCT00696436|144559071|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.43||||0.136|TWO_SIDED|95.0|-3.31|0.45||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented. Overall 0.05 level of significance for multiple comparisons was controlled using stepwise testing procedure.|ANCOVA|||||0.45|-3.31|0.136
72514111|NCT00696436|144559071|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.2||||0.001|TWO_SIDED|95.0|-5.12|-1.27||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented. Overall 0.05 level of significance for multiple comparisons was controlled using stepwise testing procedure.|ANCOVA|||||-1.27|-5.12|0.001
72514112|NCT00696436|144559072|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.92|||<|0.001|TWO_SIDED|95.0|-18.07|-11.76||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented. Overall 0.05 level of significance for multiple comparisons was controlled using stepwise testing procedure.|ANCOVA|||||-11.76|-18.07|<0.001
72514113|NCT00696436|144559072|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.55|||<|0.001|TWO_SIDED|95.0|-17.71|-11.4||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented. Overall 0.05 level of significance for multiple comparisons was controlled using stepwise testing procedure.|ANCOVA|||||-11.40|-17.71|<0.001
72514114|NCT00696436|144559072|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.54||||0.008|TWO_SIDED|95.0|-6.17|-0.92||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented. Overall 0.05 level of significance for multiple comparisons was controlled using stepwise testing procedure.|ANCOVA|||||-0.92|-6.17|0.008
72514115|NCT00696436|144559072|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.43|||<|0.001|TWO_SIDED|95.0|-8.09|-2.78||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented. Overall 0.05 level of significance for multiple comparisons was controlled using stepwise testing procedure.|ANCOVA|||||-2.78|-8.09|<0.001
72514116|NCT00696436|144559072|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.18||||0.018|TWO_SIDED|95.0|-5.81|-0.55||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented. Overall 0.05 level of significance for multiple comparisons was controlled using stepwise testing procedure.|ANCOVA|||||-0.55|-5.81|0.018
72514117|NCT00696436|144559072|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.07|||<|0.001|TWO_SIDED|95.0|-7.73|-2.42||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented. Overall 0.05 level of significance for multiple comparisons was controlled using stepwise testing procedure.|ANCOVA|||||-2.42|-7.73|<0.001
72514118|NCT00696436|144559073|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.36|||<|0.001|TWO_SIDED|95.0|-10.91|-7.81||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||-7.81|-10.91|<0.001
72514119|NCT00696436|144559073|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.58|||<|0.001|TWO_SIDED|95.0|-10.12|-7.04||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||-7.04|-10.12|<0.001
72514120|NCT00696436|144559073|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.7||||0.011|TWO_SIDED|95.0|-2.99|-0.4||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||-0.40|-2.99|0.011
72514121|NCT00696436|144559073|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.35|||<|0.001|TWO_SIDED|95.0|-3.67|-1.02||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||-1.02|-3.67|<0.001
72402973|NCT01154218|144311783|SUPERIORITY_OR_OTHER||Ratio of Adjusted means|99.6|||||TWO_SIDED|90.0|91.3|108.66||||||Natural log transformed AUClast of crizotinib was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||108.66|91.30|
72487170|NCT02248259|144502783|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Equivalence range was 80% to 125%|Geometric mean ratio (%)|113.61|STANDARD_ERROR_OF_MEAN|1.07|||TWO_SIDED|90.0|100.505|128.427|||||Ratio calculated as extensive metabolisers test treatment divided by extensive metabolisers: ref. treatment|Analysis for BI 409306||128.427|100.505|
72487171|NCT02248259|144502783|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Equivalence range was 80% to 125%|Geometric mean ratio (%)|87.91|STANDARD_ERROR_OF_MEAN|1.07|||TWO_SIDED|90.0|77.763|99.37|||||Ratio calculated as poor metabolisers test treatment divided by poor metabolisers: ref. treatment|Analysis for BI 409306||99.370|77.763|
72487172|NCT02248259|144502783|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Equivalence range was 80% to 125%|Geometric mean ratio (%)|89.05|STANDARD_ERROR_OF_MEAN|1.029|||TWO_SIDED|90.0|84.478|93.859|||||Ratio calculated as extensive metabolisers test treatment divided by extensive metabolisers: ref. treatment|Analysis for CD 13896||93.859|84.478|
72514122|NCT00696436|144559073|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.91||||0.166|TWO_SIDED|95.0|-2.19|0.38||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||0.38|-2.19|0.166
72514123|NCT00696436|144559073|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.56||||0.02|TWO_SIDED|95.0|-2.88|-0.24||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||-0.24|-2.88|0.020
72514124|NCT00696436|144559074|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.51|||<|0.001|TWO_SIDED|95.0|-9.33|-5.69||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||-5.69|-9.33|<0.001
72514125|NCT00696436|144559074|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.21|||<|0.001|TWO_SIDED|95.0|-8.03|-4.39||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||-4.39|-8.03|<0.001
72514126|NCT00696436|144559074|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.18||||0.005|TWO_SIDED|95.0|-3.69|-0.67||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||-0.67|-3.69|0.005
72514127|NCT00696436|144559074|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.17|||<|0.001|TWO_SIDED|95.0|-4.69|-1.64||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||-1.64|-4.69|<0.001
72514128|NCT00696436|144559074|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.87||||0.257|TWO_SIDED|95.0|-2.39|0.64||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||0.64|-2.39|0.257
72514129|NCT00696436|144559074|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.86||||0.017|TWO_SIDED|95.0|-3.39|-0.33||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||-0.33|-3.39|0.017
72514130|NCT00696436|144559075|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.92|||<|0.001|TWO_SIDED|95.0|-17.3|-12.54||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||-12.54|-17.30|<0.001
72514131|NCT00696436|144559075|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.63|||<|0.001|TWO_SIDED|95.0|-15.99|-11.27||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||-11.27|-15.99|<0.001
72514132|NCT00696436|144559075|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.86||||0.005|TWO_SIDED|95.0|-4.85|-0.87||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||-0.87|-4.85|0.005
72514133|NCT00696436|144559075|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.76|||<|0.001|TWO_SIDED|95.0|-6.8|-2.73||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||-2.73|-6.80|<0.001
72514134|NCT00696436|144559075|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.57||||0.119|TWO_SIDED|95.0|-3.55|0.4||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||0.40|-3.55|0.119
72514135|NCT00696436|144559075|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.47|||<|0.001|TWO_SIDED|95.0|-5.49|-1.45||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||-1.45|-5.49|<0.001
72514136|NCT00696436|144559076|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.81|||<|0.001|TWO_SIDED|95.0|-11.48|-8.13||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||-8.13|-11.48|<0.001
72514137|NCT00696436|144559076|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.96|||<|0.001|TWO_SIDED|95.0|-10.63|-7.3||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||-7.30|-10.63|<0.001
72514138|NCT00696436|144559076|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.99||||0.006|TWO_SIDED|95.0|-3.39|-0.58||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||-0.58|-3.39|0.006
72514139|NCT00696436|144559076|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.57|||<|0.001|TWO_SIDED|95.0|-4.0|-1.14||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||-1.14|-4.00|<0.001
72514140|NCT00696436|144559076|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.14||||0.107|TWO_SIDED|95.0|-2.53|0.25||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||0.25|-2.53|0.107
72514141|NCT00696436|144559076|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.73||||0.017|TWO_SIDED|95.0|-3.15|-0.3||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||-0.30|-3.15|0.017
72487173|NCT02248259|144502783|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Equivalence range was 80% to 125%|Geometric mean ratio (%)|92.48|STANDARD_ERROR_OF_MEAN|1.026|||TWO_SIDED|90.0|88.278|96.889|||||Ratio calculated as poor metabolisers test treatment divided by poor metabolisers: ref. treatment|Analysis for CD 13896||96.889|88.278|
72567943|NCT02037165|144667469|SUPERIORITY_OR_OTHER||adjusted mean difference|-1.58|STANDARD_ERROR_OF_MEAN|1.3652|||TWO_SIDED|95.0|-4.3|1.1|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 6:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||1.1|-4.3|
72567944|NCT02037165|144667469|SUPERIORITY_OR_OTHER||adjusted mean difference|-1.51|STANDARD_ERROR_OF_MEAN|1.3652|||TWO_SIDED|95.0|-4.2|1.2|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 22:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||1.2|-4.2|
72567945|NCT02037165|144667469|SUPERIORITY_OR_OTHER||adjusted mean difference|-0.83|STANDARD_ERROR_OF_MEAN|1.3652|||TWO_SIDED|95.0|-3.5|1.8|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 24:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||1.8|-3.5|
72624144|NCT01892189|144778533|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1279|STANDARD_ERROR_OF_MEAN|0.17447||0.468|TWO_SIDED|95.0|-0.2266|0.4825|||ANOVA||Difference between least square means of TAK-063 10 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Right Dorsolateral Prefrontal Cortex: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.4825|-0.2266|0.468
72402974|NCT01154218|144311783|SUPERIORITY_OR_OTHER||Ratio of Adjusted means|107.56|||||TWO_SIDED|90.0|98.58|117.35||||||Natural log transformed AUClast of crizotinib was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||117.35|98.58|
72567946|NCT02037165|144667469|SUPERIORITY_OR_OTHER||adjusted mean difference|-1.64|STANDARD_ERROR_OF_MEAN|1.3254|||TWO_SIDED|95.0|-4.2|1.0|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 0:30h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||1.0|-4.2|
72567947|NCT02037165|144667469|SUPERIORITY_OR_OTHER||adjusted mean difference|1.07|STANDARD_ERROR_OF_MEAN|1.3253|||TWO_SIDED|95.0|-1.5|3.7|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 1:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||3.7|-1.5|
72567948|NCT02037165|144667469|SUPERIORITY_OR_OTHER||adjusted mean difference|0.82|STANDARD_ERROR_OF_MEAN|1.3253|||TWO_SIDED|95.0|-1.8|3.4|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 2:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||3.4|-1.8|
72567949|NCT02037165|144667469|SUPERIORITY_OR_OTHER||adjusted mean difference|-1.32|STANDARD_ERROR_OF_MEAN|1.3253|||TWO_SIDED|95.0|-3.9|1.3|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 3:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||1.3|-3.9|
72624145|NCT01892189|144778533|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2033|STANDARD_ERROR_OF_MEAN|0.16572||0.228|TWO_SIDED|95.0|-0.5401|0.1334|||ANOVA||Difference between least square means of TAK-063 30 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Right Dorsolateral Prefrontal Cortex: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.1334|-0.5401|0.228
72567950|NCT02037165|144667469|SUPERIORITY_OR_OTHER||adjusted mean difference|0.56|STANDARD_ERROR_OF_MEAN|1.3254|||TWO_SIDED|95.0|-2.0|3.2|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 4:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||3.2|-2.0|
72567951|NCT02037165|144667469|SUPERIORITY_OR_OTHER||adjusted mean difference|-0.04|STANDARD_ERROR_OF_MEAN|1.3253|||TWO_SIDED|95.0|-2.6|2.6|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 5:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||2.6|-2.6|
72487174|NCT02248259|144502783|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Equivalence range was 80% to 125%|Geometric mean ratio (%)|99.61|STANDARD_ERROR_OF_MEAN|1.022|||TWO_SIDED|90.0|95.791|103.583|||||Ratio calculated as extensive metabolisers test treatment divided by extensive metabolisers: ref. treatment|Analysis for CD 14084||103.583|95.791|
72487175|NCT02248259|144502783|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Equivalence range was 80% to 125%|Geometric mean ratio (%)|104.44|STANDARD_ERROR_OF_MEAN|1.031|||TWO_SIDED|90.0|98.861|110.336|||||Ratio calculated as poor metabolisers test treatment divided by poor metabolisers: ref. treatment|Analysis for CD 14084||110.336|98.861|
72487176|NCT02573870|144502786|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|p-values were not presented as non-inferiority was assessed by confidence interval (CI).|Mean Difference (Final Values)|-2.245|||||TWO_SIDED|95.0|-6.153|1.663|||||Treatment difference is calculated as active minus placebo and the non-inferiority bound was 10 bpm for Day 42|||1.663|-6.153|
72487177|NCT01206062|144502789|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.75|||<|0.001|TWO_SIDED|95.0|0.64|0.89|||Regression, Cox|||||0.89|0.64|<0.001
72487178|NCT01206062|144502790|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.73||||0.003|TWO_SIDED|95.0|0.6|0.9|||Regression, Cox|||||0.90|0.60|0.003
72487179|NCT01206062|144502791|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.79||||0.58|TWO_SIDED|95.0|0.34|1.83|||Regression, Cox|||||1.83|0.34|0.58
72487180|NCT01206062|144502793|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.83||||0.1|TWO_SIDED|95.0|0.67|1.04|||Regression, Cox|||||1.04|0.67|.10
72487181|NCT01101438|144502876|SUPERIORITY||Hazard Ratio (HR)|1.01||||0.93|TWO_SIDED|95.0|0.84|1.21|||Log Rank|||||1.21|0.84|0.93
72487182|NCT01101438|144502877|SUPERIORITY||Hazard Ratio (HR)|1.01||||0.94|TWO_SIDED|95.0|0.87|1.17|||Log Rank|||||1.17|0.87|0.94
72487183|NCT01101438|144502878|SUPERIORITY||Hazard Ratio (HR)|1.02||||0.88|TWO_SIDED|95.0|0.83|1.24|||Log Rank|||||1.24|0.83|0.88
72487184|NCT01825057|144502931|SUPERIORITY||Mean Difference (Final Values)|17.5||||0.0009|TWO_SIDED|||||adjusted for multiple comparisons using Dwass, Steel, Critchlow-Fligner Method|Kruskal-Wallis|degrees of freedom = 2|mean difference = Order One - Do One|||||0.0009
72487185|NCT01825057|144502931|SUPERIORITY||Median Difference (Final Values)|19.7|||<|0.0001|TWO_SIDED|||||Adjusted for multiple comparisons using Dwass, Steel, Critchlow-Fligner Method|Kruskal-Wallis|degrees of freedom = 2|mean difference = Order One - See One|||||<0.0001
72487186|NCT01825057|144502931|SUPERIORITY||Mean Difference (Final Values)|2.178||||0.4983|TWO_SIDED||||||Kruskal-Wallis|degrees of freedom = 2|mean difference = Do One - See One|||||0.4983
72487187|NCT01825057|144502932|SUPERIORITY||Mean Difference (Final Values)|0.62||||0.0217|TWO_SIDED|||||Adjusted for multiple comparisons using the Dwass, Steel, Critchlow-Fligner Method.|Kruskal-Wallis||Mean difference = Order One - Do One|||||0.0217
72487188|NCT01825057|144502932|SUPERIORITY|mean difference is Order One - See One|Mean Difference (Final Values)|1.22||||0.0126|TWO_SIDED|||||p-value adjusted for multiple comparisons using Dwass, Steel, Critchlow-Fligner method|Kruskal-Wallis|||||||0.0126
72487189|NCT01825057|144502932|SUPERIORITY||Mean Difference (Final Values)|0.6||||0.4231|TWO_SIDED|||||p-value adjusted for multiple comparisons using Dwass, Steel, Critchlow-Fligner method|Kruskal-Wallis||mean difference is Do One - See One|||||0.4231
72487190|NCT01825057|144502933|SUPERIORITY||Mean Difference (Final Values)|0.44||||0.0091|TWO_SIDED|||||p-value adjusted for multiple comparisons using Dwass, Steel, Critchlow-Fligner method|Kruskal-Wallis||Mean difference = Order One - Do One|||||0.0091
72487191|NCT01825057|144502933|SUPERIORITY||Mean Difference (Final Values)|1.04||||0.0196|TWO_SIDED|||||p-value adjusted for multiple comparisons using Dwass, Steel, Critchlow-Fligner method|Kruskal-Wallis||mean difference = Order One - See One|||||0.0196
72487192|NCT01825057|144502933|SUPERIORITY||Mean Difference (Final Values)|0.6||||0.2832|TWO_SIDED|||||p-value adjusted for multiple comparisons using Dwass, Steel, Critchlow-Fligner method|Kruskal-Wallis||mean difference = Do One - See One|||||0.2832
72487193|NCT01825057|144502934|SUPERIORITY||Mean Difference (Final Values)|0.43||||0.1566|TWO_SIDED|||||p-value adjusted for multiple comparisons using Dwass, Steel, Critchlow-Fligner method|Kruskal-Wallis||Mean difference = Order One - Do One|||||0.1566
72487194|NCT01825057|144502934|SUPERIORITY||Mean Difference (Final Values)|0.88||||0.0982|TWO_SIDED|||||p-value adjusted for multiple comparisons using Dwass, Steel, Critchlow-Fligner method|Kruskal-Wallis||mean difference = Order One - See One|||||0.0982
72487195|NCT01825057|144502934|SUPERIORITY||Mean Difference (Final Values)|0.45||||0.6631|TWO_SIDED|||||p-value adjusted for multiple comparisons using Dwass, Steel, Critchlow-Fligner method|Kruskal-Wallis||mean difference = Do One - See One|||||0.6631
72487196|NCT01825057|144502935|SUPERIORITY||Mean Difference (Final Values)|0.24||||0.1327|TWO_SIDED|||||p-value adjusted for multiple comparisons using Dwass, Steel, Critchlow-Fligner method|Kruskal-Wallis||Mean difference = Order One - Do One|||||.1327
72487197|NCT01825057|144502935|SUPERIORITY||Mean Difference (Final Values)|0.57||||0.4097|TWO_SIDED|||||p-value adjusted for multiple comparisons using Dwass, Steel, Critchlow-Fligner method|Kruskal-Wallis||||mean difference = Order One - See One|||0.4097
72487198|NCT01825057|144502935|SUPERIORITY||Mean Difference (Final Values)|0.33||||0.8779|TWO_SIDED|||||p-value adjusted for multiple comparisons using Dwass, Steel, Critchlow-Fligner method|Kruskal-Wallis||mean difference = Do One - See One|||||0.8779
72487199|NCT04746833|144502946|EQUIVALENCE|mean of Summit will be equal to mean of control||||||0.91|||||||t-test, 2 sided|||||||.91
72487200|NCT04746833|144502947|OTHER|||||||||||||||||descriptive statistic of system use|simple descriptive findings for evaluation of feasibility of the Sumit app|||
72487201|NCT04746833|144502948|EQUIVALENCE|standard null hypothesis of no difference between groups||||||0.5|||||||t-test, 2 sided|||||||.50
72487202|NCT00290290|144502949|SUPERIORITY_OR_OTHER||Relative Risk|0.59||||0.004|TWO_SIDED|95.0|0.41|0.85|||Log Rank|||The average baseline rate of surgical-site infection at the six participating hospitals was 14% after clean-contaminated surgery with povidone-iodine skin preparation, and we estimated that substituting chlorhexidine-alcohol for povidone-iodine would reduce this rate to 7%. Therefore, we planned to enroll approximately 430 patients in each study group who could be evaluated in order for the study to have 90% power to detect a significant difference in the rates of surgical-site infection.||0.85|0.41|0.004
72487203|NCT04013789|144502950|NON_INFERIORITY|The noninferiority margin was set at 0.05.|Least Squares Mean Difference|0.02|STANDARD_ERROR_OF_MEAN|0.006|||ONE_SIDED|95.0||0.03|||Mixed Effects Repeated Measures Model||DACP FreshTech minus DACP|||0.03||
72487204|NCT00496730|144502985|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||ANCOVA|||||||<0.0001
72487205|NCT00496730|144502986|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||ANCOVA|||||||<0.0001
72487206|NCT00496730|144502987|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||ANCOVA|||||||<0.0001
72487207|NCT00427349|144503049|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||one sample binomial test|The study result was compared to a null hypothesis of 20% 4-month progression free survival rate using one sample binomial test||The null hypothesis is that the 4-month progression free survival rate is 20%. Alternatively, AMG 706 will be considered worthy of further study if its true progression-free survival rate is 40% or better at 4 months (alternative hypothesis).||||<0.001
72487208|NCT05082376|144503061|OTHER||Adjusted Mean Difference|7.7|||<|0.0001|TWO_SIDED|95.0|6.6|8.8|||ANCOVA|Analysis of Covariance (ANCOVA) model with treatment, timepoint, treatment\*timepoint (interaction) and subject as terms; Baseline value as covariate.||Pairwise comparison between Treated and Untreated sites 2 hours post-treatment||8.8|6.6|<0.0001
72487209|NCT05082376|144503061|OTHER||Adjusted Mean Difference|6.9|||<|0.0001|TWO_SIDED|95.0|5.8|7.9|||ANCOVA|ANCOVA model with treatment, timepoint, treatment\*timepoint (interaction) and subject as terms; Baseline value as covariate.||Pairwise comparison between Treated and Untreated sites 4 hours post-treatment.||7.9|5.8|<0.0001
72514142|NCT00696436|144559077|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.0|||<|0.001|TWO_SIDED|95.0|-15.56|-10.45||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||-10.45|-15.56|<0.001
72514143|NCT00696436|144559077|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.97|||<|0.001|TWO_SIDED|95.0|-14.51|-9.43||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||-9.43|-14.51|<0.001
72514144|NCT00696436|144559077|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.42||||0.194|TWO_SIDED|95.0|-3.56|0.72||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||0.72|-3.56|0.194
72514145|NCT00696436|144559077|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.65||||0.001|TWO_SIDED|95.0|-5.84|-1.46||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||-1.46|-5.84|0.001
72514146|NCT00696436|144559077|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.39||||0.72|TWO_SIDED|95.0|-2.51|1.73||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||1.73|-2.51|0.720
72487210|NCT05082376|144503061|OTHER||Adjusted Mean Difference|5.1|||<|0.0001|TWO_SIDED|95.0|4.0|6.2|||ANCOVA|ANCOVA model with treatment, timepoint, treatment\*timepoint (interaction) and subject as terms; Baseline value as covariate.||Pairwise comparison between Treated and Untreated sites 6 hours post-treatment.||6.2|4.0|<0.0001
72487211|NCT05082376|144503061|OTHER||Adjusted Mean Difference|4.7|||<|0.0001|TWO_SIDED|95.0|3.6|5.8|||ANCOVA|ANCOVA model with treatment, timepoint, treatment\*timepoint (interaction) and subject as terms; Baseline value as covariate.||Pairwise comparison between Treated and Untreated sites 8 hours post-treatment.||5.8|3.6|<0.0001
72487212|NCT03023930|144503063|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|proc logistic||||||<0.001
72487213|NCT03023930|144503064|SUPERIORITY|||||||0.011|||||||Regression, Logistic|proc logistic||||||0.011
72487214|NCT00290186|144503092|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.9||||0.539||95.0|-1.5|3.3|||ANCOVA|||Between-group difference: positive values represent greater improvement in HBO group.||3.3|-1.5|0.539
72487215|NCT00290186|144503093|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||0.921|TWO_SIDED|95.0|-1.6|1.8|||ANCOVA|||Between-group difference: positive values represent greater improvement in HBO group.||1.8|-1.6|0.921
72487216|NCT00290186|144503094|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.1||||0.945|TWO_SIDED|95.0|-3.0|5.1|||ANCOVA|||Between-group difference: positive values represent greater improvement in HBO group.||5.1|-3.0|0.945
72487217|NCT00290186|144503095|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.4||||0.342|TWO_SIDED|95.0|-5.1|2.2|||ANCOVA|||Between-group difference: positive values represent greater improvement in HBO group.||2.2|-5.1|0.342
72514147|NCT00696436|144559077|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.62||||0.018|TWO_SIDED|95.0|-4.79|-0.45||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||-0.45|-4.79|0.018
72514148|NCT00696436|144559078|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.64|||<|0.001|TWO_SIDED|95.0|-10.42|-6.87||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||-6.87|-10.42|<0.001
72514149|NCT00696436|144559078|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.75|||<|0.001|TWO_SIDED|95.0|-9.52|-5.99||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||-5.99|-9.52|<0.001
72514150|NCT00696436|144559078|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.72||||0.341|TWO_SIDED|95.0|-2.21|0.77||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||0.77|-2.21|0.341
72514151|NCT00696436|144559078|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.28||||0.003|TWO_SIDED|95.0|-3.8|-0.76||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||-0.76|-3.80|0.003
72514152|NCT00696436|144559078|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.17||||0.821|TWO_SIDED|95.0|-1.3|1.64||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||1.64|-1.30|0.821
72514153|NCT00696436|144559078|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.39||||0.071|TWO_SIDED|95.0|-2.89|0.12||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||0.12|-2.89|0.071
72514154|NCT00696436|144559079|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.45|||<|0.001|TWO_SIDED|95.0|-17.96|-12.94||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||-12.94|-17.96|<0.001
72514155|NCT00696436|144559079|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.93|||<|0.001|TWO_SIDED|95.0|-16.42|-11.43||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||-11.43|-16.42|<0.001
72514156|NCT00696436|144559079|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.32||||0.002|TWO_SIDED|95.0|-5.42|-1.22||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||-1.22|-5.42|0.002
72514157|NCT00696436|144559079|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.11|||<|0.001|TWO_SIDED|95.0|-7.26|-2.97||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||-2.97|-7.26|<0.001
72514158|NCT00696436|144559079|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.8||||0.091|TWO_SIDED|95.0|-3.88|0.29||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||0.29|-3.88|0.091
72514159|NCT00696436|144559079|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.59|||<|0.001|TWO_SIDED|95.0|-5.72|-1.46||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||-1.46|-5.72|<0.001
72514160|NCT00696436|144559080|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.14|||<|0.001|TWO_SIDED|95.0|-11.92|-8.36||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||-8.36|-11.92|<0.001
72514161|NCT00696436|144559080|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.17|||<|0.001|TWO_SIDED|95.0|-10.94|-7.4||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||-7.40|-10.94|<0.001
72514162|NCT00696436|144559080|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.31||||0.002|TWO_SIDED|95.0|-3.81|-0.82||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||-0.82|-3.81|0.002
72514163|NCT00696436|144559080|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.71|||<|0.001|TWO_SIDED|95.0|-4.24|-1.19||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||-1.19|-4.24|<0.001
72514164|NCT00696436|144559080|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.34||||0.076|TWO_SIDED|95.0|-2.82|0.14||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||0.14|-2.82|0.076
72514165|NCT00696436|144559080|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.74||||0.024|TWO_SIDED|95.0|-3.25|-0.22||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||-0.22|-3.25|0.024
72514166|NCT00696436|144559081|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.84|||<|0.001|TWO_SIDED|95.0|-15.66|-10.02||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||-10.02|-15.66|<0.001
72514167|NCT00696436|144559081|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.91|||<|0.001|TWO_SIDED|95.0|-14.72|-9.11||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||-9.11|-14.72|<0.001
72514168|NCT00696436|144559081|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.74||||0.149|TWO_SIDED|95.0|-4.1|0.62||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||0.62|-4.10|0.149
72514169|NCT00696436|144559081|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.24|||<|0.001|TWO_SIDED|95.0|-6.65|-1.83||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||-1.83|-6.65|<0.001
72514170|NCT00696436|144559081|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.82||||0.494|TWO_SIDED|95.0|-3.16|1.53||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||1.53|-3.16|0.494
72514171|NCT00696436|144559081|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.32||||0.007|TWO_SIDED|95.0|-5.72|-0.93||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||-0.93|-5.72|0.007
72514172|NCT00696436|144559082|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.91|||<|0.001|TWO_SIDED|95.0|-10.03|-5.79||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||-5.79|-10.03|<0.001
72514173|NCT00696436|144559082|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.99|||<|0.001|TWO_SIDED|95.0|-10.1|-5.88||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||-5.88|-10.10|<0.001
72514174|NCT00696436|144559082|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.36||||0.691|TWO_SIDED|95.0|-2.14|1.42||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||1.42|-2.14|0.691
72514175|NCT00696436|144559082|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.39||||0.01|TWO_SIDED|95.0|-4.2|-0.57||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||-0.57|-4.20|0.010
72514176|NCT00696436|144559082|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.44||||0.625|TWO_SIDED|95.0|-2.2|1.32||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||1.32|-2.20|0.625
72514177|NCT00696436|144559082|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.46||||0.008|TWO_SIDED|95.0|-4.27|-0.66||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||-0.66|-4.27|0.008
72514178|NCT00696436|144559083|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.98|||<|0.001|TWO_SIDED|95.0|3.15|7.88||P-value for response criteria for systolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value was presented.|Regression, Logistic|||||7.88|3.15|<0.001
72514179|NCT00696436|144559083|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.66|||<|0.001|TWO_SIDED|95.0|2.94|7.37||P-value for response criteria for systolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value was presented.|Regression, Logistic|||||7.37|2.94|<0.001
72514180|NCT00696436|144559083|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.45||||0.032|TWO_SIDED|95.0|1.03|2.03||P-value for response criteria for systolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value was presented.|Regression, Logistic|||||2.03|1.03|0.032
72514181|NCT00696436|144559083|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.46||||0.029|TWO_SIDED|95.0|1.04|2.06||P-value for response criteria for systolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value was presented.|Regression, Logistic|||||2.06|1.04|0.029
72514182|NCT00696436|144559083|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.35||||0.08|TWO_SIDED|95.0|0.96|1.89||P-value for response criteria for systolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value was presented.|Regression, Logistic|||||1.89|0.96|0.080
72514183|NCT00696436|144559083|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.37||||0.071|TWO_SIDED|95.0|0.97|1.92||P-value for response criteria for systolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value was presented.|Regression, Logistic|||||1.92|0.97|0.071
72514184|NCT00696436|144559084|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.29|||<|0.001|TWO_SIDED|95.0|2.1|5.15||P-value for response criteria for diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic diastolic blood pressure as a covariate. The unadjusted p-value was presented.|Regression, Logistic|||||5.15|2.10|<0.001
72514185|NCT00696436|144559084|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.91|||<|0.001|TWO_SIDED|95.0|1.86|4.54||P-value for response criteria for diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic diastolic blood pressure as a covariate. The unadjusted p-value was presented.|Regression, Logistic|||||4.54|1.86|<0.001
72514186|NCT00696436|144559084|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.22||||0.306|TWO_SIDED|95.0|0.83|1.8||P-value for response criteria for diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic diastolic blood pressure as a covariate. The unadjusted p-value was presented.|Regression, Logistic|||||1.80|0.83|0.306
72514187|NCT00696436|144559084|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.34||||0.132|TWO_SIDED|95.0|0.92|1.97||P-value for response criteria for diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic diastolic blood pressure as a covariate. The unadjusted p-value was presented.|Regression, Logistic|||||1.97|0.92|0.132
72514188|NCT00696436|144559084|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.08||||0.695|TWO_SIDED|95.0|0.74|1.58||P-value for response criteria for diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic diastolic blood pressure as a covariate. The unadjusted p-value was presented.|Regression, Logistic|||||1.58|0.74|0.695
72514189|NCT00696436|144559084|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.19||||0.381|TWO_SIDED|95.0|0.81|1.74||P-value for response criteria for diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic diastolic blood pressure as a covariate. The unadjusted p-value was presented.|Regression, Logistic|||||1.74|0.81|0.381
72514190|NCT00696436|144559085|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.18|||<|0.001|TWO_SIDED|95.0|3.2|8.41||P-value for joint response criteria for systolic blood pressure and diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value was presented.|Regression, Logistic|||||8.41|3.20|<0.001
72514191|NCT00696436|144559085|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.43|||<|0.001|TWO_SIDED|95.0|2.73|7.19||P-value for joint response criteria for systolic blood pressure and diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value was presented.|Regression, Logistic|||||7.19|2.73|<0.001
72514192|NCT00696436|144559085|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.39||||0.056|TWO_SIDED|95.0|0.99|1.94||P-value for joint response criteria for systolic blood pressure and diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value was presented.|Regression, Logistic|||||1.94|0.99|0.056
72487218|NCT00290186|144503096|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.5||||0.149|TWO_SIDED|95.0|-1.6|8.6|||ANCOVA|||Between-group difference: positive values represent greater improvement in HBO group.||8.6|-1.6|0.149
72487219|NCT00290186|144503097|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.0||||0.685|TWO_SIDED|95.0|-3.0|5.1|||ANCOVA|||Between-group difference: positive values represent greater improvement in HBO group.||5.1|-3.0|0.685
72514193|NCT00696436|144559085|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.44||||0.036|TWO_SIDED|95.0|1.02|2.02||P-value for joint response criteria for systolic blood pressure and diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value was presented.|Regression, Logistic|||||2.02|1.02|0.036
72514194|NCT00696436|144559085|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.19||||0.317|TWO_SIDED|95.0|0.85|1.66||P-value for joint response criteria for systolic blood pressure and diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value was presented.|Regression, Logistic|||||1.66|0.85|0.317
72514195|NCT00696436|144559085|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.23||||0.234|TWO_SIDED|95.0|0.87|1.73||P-value for joint response criteria for systolic blood pressure and diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value was presented.|Regression, Logistic|||||1.73|0.87|0.234
72514196|NCT02062463|144559098|OTHER||Odds Ratio (OR)|3.77|||<|0.001|TWO_SIDED|95.0|2.05|6.95||Threshold for significance at 0.05 level.|Chi-squared|||Analysis was performed using a conditional logistic regression model.||6.95|2.05|<0.001
72514197|NCT02062463|144559099|OTHER||Odds Ratio (OR)|1.26||||0.316|TWO_SIDED|95.0|0.8|1.98||Threshold for significance at 0.05 level.|Chi-squared|||Analysis was performed using a conditional logistic regression model.||1.98|0.80|0.316
72514198|NCT04124692|144559117|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||||||<0.0001
72514199|NCT04124692|144559118|SUPERIORITY||||||=|0.0043|||||||Fisher Exact|||||||= 0.0043
72577038|NCT00261443|144680753|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0||||0.904|TWO_SIDED|95.0|-0.04|0.04||ANOVA model, controlling for treatment and mood stabilizer, is used for baseline. ANCOVA model, controlling for treatment, mood stabilizer, and baseline value, is used for mean change from baseline.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences and p-values are based on the ANOVA/ANCOVA model.||Week 52 LOCF Treatment Difference||0.04|-0.04|0.904
72487220|NCT00290186|144503098|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3||||0.584|TWO_SIDED|95.0|-2.4|3.0|||ANCOVA|||Between-group difference: positive values represent greater improvement in HBO group.||3.0|-2.4|0.584
72402975|NCT01154218|144311783|SUPERIORITY_OR_OTHER||Ratio of Adjusted means|85.52|||||TWO_SIDED|90.0|78.45|93.22||||||Natural log transformed AUClast of crizotinib was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||93.22|78.45|
72487221|NCT00290186|144503099|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.1||||0.498|TWO_SIDED|95.0|-1.5|3.7|||ANCOVA|||Between-group difference: positive values represent greater improvement in HBO group.||3.7|-1.5|0.498
72487222|NCT00290186|144503100|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||0.945|TWO_SIDED|95.0|-2.3|2.2|||ANCOVA|||Between-group difference: positive values represent greater improvement in HBO group.||2.2|-2.3|0.945
72487223|NCT00290186|144503101|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||0.932|TWO_SIDED|95.0|-2.1|2.4|||ANCOVA|||Between-group difference: positive values represent greater improvement in HBO group.||2.4|-2.1|0.932
72514200|NCT04124692|144559118|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||||||<0.0001
72514201|NCT02370498|144559139|OTHER||Hazard Ratio (HR)|1.27||||0.98358|TWO_SIDED|95.0|1.03|1.57||One-sided p-value based on log-rank test stratified by geographic region (Europe/Israel/North America/Australia vs. Asia vs. Rest of World) and TTP on first-line therapy (\< 6 months vs. \>= 6 months).|Regression, Cox|P-value rounded to 5 decimal places.||Treatment difference in PFS was assessed by the Stratified Log-rank test, and a stratified Cox proportional hazard model with Efron's method of tie handling was used to assess the magnitude of the treatment difference (Hazard Ratio \[HR\]) between the treatment arms.||1.57|1.03|0.98358
72514202|NCT02370498|144559140|OTHER||Hazard Ratio (HR)|0.82||||0.04205|TWO_SIDED|95.0|0.66|1.03||One-sided p-value based on log-rank test stratified by geographic region (Europe/Israel/North America/Australia vs. Asia vs. Rest of World) and TTP on first-line therapy (\< 6 months vs. \>= 6 months).|Regression, Cox|P-value rounded to 5 decimal places.||Treatment difference in OS was assessed by the Stratified Log-rank test, and a stratified Cox proportional hazard model with Efron's method of tie handling was used to assess the magnitude of the treatment difference (HR) between the treatment arms.||1.03|0.66|0.04205
72514203|NCT02370498|144559141|OTHER||Hazard Ratio (HR)|1.49||||0.99999|TWO_SIDED|95.0|1.25|1.77||One-sided p-value based on log-rank test stratified by geographic region (Europe/Israel/North America/Australia vs. Asia vs. Rest of World), TTP on first-line therapy (\< 6 months vs. \>= 6 months), and PD-L1 status (positive vs. negative).|Regression, Cox|P-value rounded to 5 decimal places.||Treatment difference in PFS was assessed by the Stratified Log-rank test, and a stratified Cox proportional hazard model with Efron's method of tie handling was used to assess the magnitude of the treatment difference (Hazard Ratio \[HR\]) between the treatment arms.||1.77|1.25|0.99999
72567952|NCT02037165|144667469|SUPERIORITY_OR_OTHER||adjusted mean difference|-2.05|STANDARD_ERROR_OF_MEAN|1.3253|||TWO_SIDED|95.0|-4.7|0.6|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 6:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||0.6|-4.7|
72567953|NCT02037165|144667469|SUPERIORITY_OR_OTHER||adjusted mean difference|0.4|STANDARD_ERROR_OF_MEAN|1.3253|||TWO_SIDED|95.0|-2.2|3.0|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 22:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||3.0|-2.2|
72567954|NCT02037165|144667469|SUPERIORITY_OR_OTHER||adjusted mean difference|-0.26|STANDARD_ERROR_OF_MEAN|1.3254|||TWO_SIDED|95.0|-2.9|2.3|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 24:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||2.3|-2.9|
72567955|NCT02037165|144667470|SUPERIORITY_OR_OTHER||adjusted mean difference|-0.96|STANDARD_ERROR_OF_MEAN|1.2419|||TWO_SIDED|95.0|-3.4|1.5|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 0:30h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||1.5|-3.4|
72487224|NCT00290186|144503102|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.3||||0.051|TWO_SIDED|95.0|-0.2|4.7|||ANCOVA|||Between-group difference: positive values represent greater improvement in HBO group.||4.7|-0.2|0.051
72567956|NCT02037165|144667470|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.97|STANDARD_ERROR_OF_MEAN|1.2418|||TWO_SIDED|95.0|-4.4|0.5|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 1:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||0.5|-4.4|
72402976|NCT01154218|144311786|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|106.97|||||TWO_SIDED|90.0|96.55|118.51||||||Natural log transformed Cmax of crizotinib was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||118.51|96.55|
72487225|NCT00290186|144503103|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6||||0.648|TWO_SIDED|95.0|-4.0|2.8|||ANCOVA|||Between-group difference: positive values represent greater improvement in HBO group.||2.8|-4.0|0.648
72487226|NCT00290186|144503104|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.7||||0.473|TWO_SIDED|95.0|-4.7|1.4|||ANCOVA|||Between-group difference: positive values represent greater improvement in HBO group.||1.4|-4.7|0.473
72514204|NCT02370498|144559142|OTHER||Hazard Ratio (HR)|0.94||||0.24463|TWO_SIDED|95.0|0.79|1.12||One-sided p-value based on log-rank test stratified by geographic region (Europe/Israel/North America/Australia vs. Asia vs. Rest of World), TTP on first-line therapy (\<6 months vs. ≥6 months), and PD-L1 status (positive vs. negative).|Regression, Cox|P-value rounded to 5 decimal places.||Treatment difference in OS was assessed by the Stratified Log-rank test, and a stratified Cox proportional hazard model with Efron's method of tie handling was used to assess the magnitude of the treatment difference (Hazard Ratio \[HR\]) between the treatment arms.||1.12|0.79|0.24463
72567957|NCT02037165|144667470|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.64|STANDARD_ERROR_OF_MEAN|1.2418|||TWO_SIDED|95.0|-4.1|0.8|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 2:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||0.8|-4.1|
72487227|NCT00290186|144503105|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|46.0||||0.157|TWO_SIDED|95.0|-22.0|114.0|||t-test, 2 sided|||Between-group difference: positive values represent greater improvement in HBO group.||114|-22|0.157
72514205|NCT02370498|144559143|OTHER||Hazard Ratio (HR)|0.98||||0.41331|TWO_SIDED|95.0|0.79|1.21||One-sided p-value based on log-rank test stratified by geographic region (Europe/Israel/North America/Australia vs. Asia vs. Rest of World) and TTP on first-line therapy (\<6 months vs. ≥6 months).|Regression, Cox|P-value rounded to 5 decimal places.||Treatment difference in PFS was assessed by the Stratified Log-rank test, and a stratified Cox proportional hazard model with Efron's method of tie handling was used to assess the magnitude of the treatment difference (HR) between the treatment arms.||1.21|0.79|0.41331
72487228|NCT00290186|144503106|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0||||0.876|TWO_SIDED|95.0|-15.0|13.0|||t-test, 2 sided|||Between-group difference: positive values represent greater improvement in HBO group.||13|-15|0.876
72487229|NCT00290186|144503107|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-79.0||||0.167|TWO_SIDED|95.0|-198.0|41.0|||t-test, 2 sided|||Between-group difference: negative values represent greater improvement in HBO group.||41|-198|0.167
72487230|NCT00290186|144503108|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-38.0||||0.468|TWO_SIDED|95.0|-153.0|77.0|||t-test, 2 sided|||Between-group difference: negative values represent greater improvement in HBO group.||77|-153|0.468
72487231|NCT00445224|144503114|SUPERIORITY_OR_OTHER|||||||0.041||95.0|||||ANOVA|||||||.041
72487232|NCT00445224|144503115|SUPERIORITY_OR_OTHER|||||||0.049||95.0|||||ANOVA|||Repeated measures ANOVA for group and time||||.049
72487233|NCT04391036|144503117|SUPERIORITY||||||>|0.99|||||||McNemar|||This was a paired analysis comparing successful insertion of the high and low Eudragit® Films. The McNemar's test statistic is based on the discordant pairs (number of participants with high successful, low unsuccessful versus low successful, high unsuccessful).||||>.99
72514206|NCT02370498|144559144|OTHER||Hazard Ratio (HR)|1.19||||0.97481|TWO_SIDED|95.0|1.0|1.42||One-sided p-value based on log-rank test stratified by geographic region (Europe/Israel/North America/Australia vs. Asia vs. Rest of World), TTP on first-line therapy (\<6 months vs. ≥6 months), and PD-L1 status (positive vs. negative).|Regression, Cox|P-value rounded to 5 decimal places.||Treatment difference in PFS was assessed by the Stratified Log-rank test, and a stratified Cox proportional hazard model with Efron's method of tie handling was used to assess the magnitude of the treatment difference (HR) between the treatment arms.||1.42|1.00|0.97481
72514207|NCT02370498|144559145|OTHER||Hazard Ratio (HR)|1.11||||0.80696|TWO_SIDED|95.0|0.89|1.38||One-sided p-value based on log-rank test stratified by geographic region (Europe/Israel/North America/Australia vs. Asia vs. Rest of World) and TTP on first-line therapy (\<6 months vs. ≥6 months).|Regression, Cox|P-value rounded to 5 decimal places.||Treatment difference in PFS was assessed by the Stratified Log-rank test, and a stratified Cox proportional hazard model with Efron's method of tie handling was used to assess the magnitude of the treatment difference (HR) between the treatment arms.||1.38|0.89|0.80696
72514208|NCT02370498|144559146|OTHER||Hazard Ratio (HR)|1.34||||0.99932|TWO_SIDED|95.0|1.12|1.6||One-sided p-value based on log-rank test stratified by geographic region (Europe/Israel/North America/Australia vs. Asia vs. Rest of World), TTP on first-line therapy (\< 6 months vs. \>= 6 months), and PD-L1 status (positive vs. negative).|Regression, Cox|P-value rounded to 5 decimal places.||Treatment difference in PFS was assessed by the Stratified Log-rank test, and a stratified Cox proportional hazard model with Efron's method of tie handling was used to assess the magnitude of the treatment difference (HR) between the treatment arms.||1.60|1.12|0.99932
72514209|NCT02370498|144559147|OTHER||Hazard Ratio (HR)|1.45||||0.99661|TWO_SIDED|95.0|1.11|1.89||One-sided p-value based on log-rank test stratified by geographic region (Europe/Israel/North America/Australia vs. Asia vs. Rest of World) and TTP on first-line therapy (\<6 months vs. ≥6 months).|Regression, Cox|P-value rounded to 5 decimal places.||Treatment difference in TTP was assessed by the Stratified Log-rank test, and a stratified Cox proportional hazard model with Efron's method of tie handling was used to assess the magnitude of the treatment difference (HR) between the treatment arms.||1.89|1.11|0.99661
72567958|NCT02037165|144667470|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.55|STANDARD_ERROR_OF_MEAN|1.2418|||TWO_SIDED|95.0|-3.0|1.9|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 3:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||1.9|-3.0|
72487234|NCT04391036|144503118|SUPERIORITY|||||||0.45||||||This was a paired analysis comparing difficulty of insertion of the high and low Eudragit® Films. The McNemar's test is based on discordant pairs (high was not difficult, low was difficult versus low was not difficult, high was difficult).|McNemar|||||||.45
72487235|NCT04391036|144503119|SUPERIORITY|||||||0.26|||||||Fisher Exact|This was an overall Fisher's exact test so the analysis applies to all categories.||||||.26
72487236|NCT04085523|144503120|SUPERIORITY||||||=|0.6004|||||||ANCOVA|||ANCOVA model using treatment (dose groups and pooled placebo) and sex as fixed effects, and baseline age and baseline height SDS as the covariates.||||= 0.6004
72487237|NCT04085523|144503120|SUPERIORITY||||||=|0.7022|||||||ANCOVA|||ANCOVA model using treatment (dose groups and pooled placebo) and sex as fixed effects, and baseline age and baseline height SDS as the covariates.||||= 0.7022
72487238|NCT04085523|144503120|SUPERIORITY||||||=|0.0849|||||||ANCOVA|||ANCOVA model using treatment (dose groups and pooled placebo) and sex as fixed effects, and baseline age and baseline height SDS as the covariates.||||= 0.0849
72487239|NCT04085523|144503120|SUPERIORITY||||||=|0.0218|||||||ANCOVA|||ANCOVA model using treatment (dose groups and pooled placebo) and sex as fixed effects, and baseline age and baseline height SDS as the covariates.||||= 0.0218
72487240|NCT01877915|144503126|SUPERIORITY||Hazard Ratio (HR)|0.94||||0.27|TWO_SIDED|95.0|0.84|1.05|||Log Rank|||Statistical Analysis 1||1.05|0.84|0.270
72487241|NCT01877915|144503132|SUPERIORITY||Hazard Ratio (HR)|1.03||||0.951|TWO_SIDED|95.0|0.41|2.59|||Log Rank|||Statistical Analysis 1 (Fatal Bleeding)||2.59|0.41|0.951
72487242|NCT01877915|144503132|SUPERIORITY||Hazard Ratio (HR)|0.67||||0.253|TWO_SIDED|95.0|0.33|1.34|||Log Rank|||Statistical Analysis 2 (Bleeding in Critical Space with Potential for Permanent Disability)||1.34|0.33|0.253
72487243|NCT01357577|144503162|OTHER|||||||0.48||||||P-Value show above is for post-assessment time point.|Mixed Models Analysis|Mixed-model p-values are adjusted for study site and the baseline total CAPS score.||||||.48
72487244|NCT01357577|144503162|OTHER|||||||0.12||||||The p-value shown above is for the 6-month time point.|Mixed Models Analysis|Mixed-model p-values are adjusted for study site and the baseline total CAPS score.||||||.12
72487245|NCT01357577|144503162|OTHER|||||||0.65||||||The p-value shown above refers to the treatment main effect.|Mixed Models Analysis|||||||.65
72487246|NCT01357577|144503162|OTHER|||||||0.072||||||The p-value shown above refers to the timepoint main effect.|Mixed Models Analysis|||||||.072
72487247|NCT01357577|144503162|OTHER|||||||0.005|||||||Mixed Models Analysis|The p-value shown above refers to the interaction.||||||.0050
72487248|NCT01357577|144503162|OTHER|||||||0.12|||||||Mixed Models Analysis|The p-value shown above refers to the site main effect.||||||.12
72487249|NCT01357577|144503163|OTHER|mixed-effects linear regression model adjusted for study site and the baseline value of the dependent variable.||||||0.12||||||Post-treatment P-value.|Mixed Models Analysis|Mixed-model p-values are adjusted for study site and baseline ASI (Alcohol Use) score.||||||.12
72487250|NCT01357577|144503163|OTHER|||||||0.84||||||6-month P-Value.|Mixed Models Analysis|Mixed-model p-values adjusted for study site and Baseline ASI (Alcohol Use) score.||||||.84
72487251|NCT01357577|144503163|OTHER|||||||0.26||||||treatment main effect|Mixed Models Analysis|Mixed-model p-values adjusted for study site and Baseline ASI (Alcohol Use) score.||||||.26
72487252|NCT01357577|144503163|OTHER|||||||0.14||||||Timepoint main effect P-value|Mixed Models Analysis|Mixed-model p-values adjusted for study site and Baseline ASI (Alcohol Use) score.||||||.14
72487253|NCT01357577|144503163|OTHER|||||||0.29||||||interaction|Mixed Models Analysis|Mixed-model p-values adjusted for study site and Baseline ASI (Alcohol Use) score.||||||.29
72487254|NCT01357577|144503163|OTHER|||||||0.16||||||Site main effect P-Value.|Mixed Models Analysis|Mixed-model p-values adjusted for study site and Baseline ASI (Alcohol Use) score.||||||.16
72487255|NCT01357577|144503164|OTHER|||||||0.66||||||Post-treatment p-value.|Mixed Models Analysis|Mixed-model p-values are adjusted for study site and baseline ASI (drug score).||||||.66
72487256|NCT01357577|144503164|OTHER|||||||0.53||||||6-month P-Value.|Mixed Models Analysis|Mixed model p-values are adjusted for study site and baseline ASI (Drug Use) score.||||||.53
72567959|NCT02037165|144667470|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.29|STANDARD_ERROR_OF_MEAN|1.2418|||TWO_SIDED|95.0|-2.1|2.7|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 4:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||2.7|-2.1|
72487257|NCT01357577|144503164|OTHER|||||||0.86||||||Treatment main effect P-Value.|Mixed Models Analysis|Mixed model p-values are adjusted for study site and baseline ASI (Drug Use) score.||||||.86
72487258|NCT01357577|144503164|OTHER|||||||0.16||||||Timepoint main effect P-Value.|Mixed Models Analysis|Mixed model p-values are adjusted for study site and baseline ASI (Drug Use) score.||||||.16
72487259|NCT01357577|144503164|OTHER|||||||0.47||||||Interaction P-Value.|Mixed Models Analysis|Mixed model p-values are adjusted for study site and baseline ASI (Drug Use) score.||||||.47
72487260|NCT01357577|144503164|OTHER|||||||0.19||||||Site main effect P-Value.|Mixed Models Analysis|Mixed model p-values are adjusted for study site and baseline ASI (Drug Use) score.||||||.19
72487261|NCT01357577|144503165|OTHER|||||||0.18||||||Post-Treatment P-Value.|Mixed Models Analysis|Mixed model p-values are adjusted for study site and baseline PCL score.||||||.18
72487262|NCT01357577|144503165|OTHER|||||||0.45||||||P-value at 6 months.|Mixed Models Analysis|Mixed model p-values are adjusted for study site and baseline PCL score.||||||.45
72487263|NCT01357577|144503165|OTHER|||||||0.73||||||Treatment main effect P-Value.|Mixed Models Analysis|Mixed model p-values are adjusted for study site and baseline PCL score.||||||.73
72487264|NCT01357577|144503165|OTHER|||||||0.63||||||Timepoint main effect P-Value|Mixed Models Analysis|Mixed model p-values are adjusted for study site and baseline PCL score.||||||.63
72487265|NCT01357577|144503165|OTHER|||||||0.024||||||Interaction P-Value.|Mixed Models Analysis|Mixed model p-values are adjusted for study site and baseline PCL score.||||||.024
72487266|NCT01357577|144503165|OTHER|||||||0.15||||||Site main effect P-Value.|Mixed Models Analysis|Mixed model p-values are adjusted for study site and baseline PCL score.||||||.15
72487267|NCT01357577|144503166|OTHER|||||||0.48||||||Post-Treatment P-Value.|Mixed Models Analysis|Mixed model p-values are adjusted for study site and baseline PHQ score.||||||.48
72487268|NCT01357577|144503166|OTHER|||||||0.2||||||6-Month P-Value.|Mixed Models Analysis|Mixed model p-values are adjusted for study site and baseline PHQ score.||||||.20
72487269|NCT01357577|144503166|OTHER|||||||0.26||||||Treatment main effect P-Value.|Mixed Models Analysis|Mixed model p-values are adjusted for study site and baseline PHQ score.||||||.26
72487270|NCT01357577|144503166|OTHER|||||||0.71||||||Timepoint main effect.|Mixed Models Analysis|Mixed model p-values are adjusted for study site and baseline PHQ score.||||||.71
72487271|NCT01357577|144503166|OTHER|||||||0.56||||||Interaction main effect P-Value.|Mixed Models Analysis|Mixed model p-values are adjusted for study site and baseline PHQ score.||||||.56
72487272|NCT01357577|144503166|OTHER|||||||0.51||||||Site main effect P-Value.|Mixed Models Analysis|Mixed model p-values are adjusted for study site and baseline PHQ score.||||||.51
72487273|NCT03697720|144503167|SUPERIORITY||||||<|0.0001||||||The a priori threshold for statistical significance was .05|t-test, 2 sided|Paired t-test||Paired t-tests were used to compare worst menstrual pain rating across diary day (0-10 numeric rating scale) from baseline and at 6-8 maths followup.||||<0.0001
72487274|NCT03697720|144503168|SUPERIORITY|||||||0.119|||||||t-test, 2 sided|paired t-test||||||.119
72487275|NCT04456764|144503169|SUPERIORITY|||||||0.55||||||Test for group by time interaction.|Mixed Models Analysis|Adjusted for clustering.||||||0.55
72487276|NCT04456764|144503170|SUPERIORITY|||||||0.12||||||group x time interaction|Mixed Models Analysis|random agency and a random participant effect||||||0.12
72487277|NCT04456764|144503171|SUPERIORITY|||||||0.0986|||||||Mixed Models Analysis|Adjusted for clustering.||||||0.0986
72487278|NCT04456764|144503172|SUPERIORITY|||||||0.51||||||Group by time interaction.|Mixed Models Analysis|Adjusted for clustering.||||||0.51
72487279|NCT04456764|144503173|SUPERIORITY|||||||0.04||||||Group by time interaction.|Mixed Models Analysis|Adjusted for clustering.||||||0.04
72487280|NCT04456764|144503174|SUPERIORITY|||||||0.02||||||Group by time interaction.|Mixed Models Analysis|Adjusted for clustering.||||||0.02
72487281|NCT03496012|144503176|SUPERIORITY||Difference in Proportions|2.9|||=|0.354|TWO_SIDED|95.0|-3.1|15.0|||Fisher's Exact|||||15|-3.1|=0.354
72487282|NCT03496012|144503176|SUPERIORITY||Difference in proportions|4.6|||=|0.245|TWO_SIDED|95.0|-1.4|12.8|||Fisher's Exact|||||12.8|-1.4|=0.245
72567960|NCT02037165|144667470|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.39|STANDARD_ERROR_OF_MEAN|1.2418|||TWO_SIDED|95.0|-2.1|2.8|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 5:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||2.8|-2.1|
72567961|NCT02037165|144667470|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.11|STANDARD_ERROR_OF_MEAN|1.2418|||TWO_SIDED|95.0|-2.3|2.6|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 6:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||2.6|-2.3|
72487283|NCT03496012|144503178|SUPERIORITY||Difference in proportions|16.0|||||TWO_SIDED|95.0|5.3|32.2||||||||32.2|5.3|
72487284|NCT03496012|144503178|SUPERIORITY||Difference in proportions|12.2|||||TWO_SIDED|95.0|3.5|23.0||||||||23|3.5|
72487285|NCT03496012|144503179|SUPERIORITY||Difference in proportions|2.8|||||TWO_SIDED|95.0|-17.2|21.0||||||||21|-17.2|
72487286|NCT03496012|144503179|SUPERIORITY||Difference in proportions|15.3|||||TWO_SIDED|95.0|0.3|30.1||||||||30.1|0.3|
72487287|NCT01439282|144503195|SUPERIORITY_OR_OTHER_LEGACY|||||||0.108||||||1-side P value was obtained|1-sample binomial test|||||||0.1080
72487288|NCT04096274|144503209|SUPERIORITY|||||||0.014|||||||Mixed Models Analysis|||||||.014
72487289|NCT04096274|144503210|SUPERIORITY|||||||0.023|||||||Mixed Models Analysis|||||||.023
72487290|NCT04096274|144503211|SUPERIORITY|||||||0.188|||||||Mixed Models Analysis|||||||.188
72487291|NCT04096274|144503212|SUPERIORITY|||||||0.782|||||||Mixed Models Analysis|||||||.782
72487292|NCT00937937|144503213|SUPERIORITY_OR_OTHER_LEGACY||1-year overall survival estimate|0.38|||||TWO_SIDED|95.0|0.27|0.49||||||one-year overall survival estimate.||0.49|0.27|
72487293|NCT00937937|144503214|SUPERIORITY_OR_OTHER_LEGACY||6-month PFS estimate|0.07|||||TWO_SIDED|95.0|0.03|0.15||||||6-month PFS estimate.||0.15|0.03|
72487294|NCT02807480|144503219|OTHER|Correlation between conflict approach behavior and GAD-7 scores at baseline|Pearson correlation|0.23||||0.088|TWO_SIDED||||||Pearson correlation|||||||.088
72487295|NCT02807480|144503219|OTHER||Pearson correlation|-0.2||||0.134|TWO_SIDED||||||Pearson correlation|||Correlation of baseline response time during conflict with baseline GAD-7 scores.||||.134
72487296|NCT02807480|144503219|OTHER||Pearson correlation|0.12||||0.032|TWO_SIDED||||||Pearson correlation|||Correlation of baseline striatum response to points (reward) with baseline GAD-7 scores.||||.032
72487297|NCT02807480|144503219|OTHER||Pearson correlation|-0.12||||0.375|TWO_SIDED||||||Pearson correlation|||Correlation of baseline right amygdala activity during negative images with baseline GAD7 scores||||0.375
72487298|NCT02807480|144503219|OTHER||Pearson correlation|0.06||||0.651|TWO_SIDED||||||Pearson correlation|||Correlation of baseline right dlPFC activity during conflict decision-making with baseline GAD-7 scores.||||.651
72487299|NCT02807480|144503219|OTHER|Correlation of baseline striatum response to negative pictures with baseline GAD-7 scores.|Pearson correlation|-0.35||||0.008|TWO_SIDED||||||Pearson correlation|||||||.008
72487300|NCT02807480|144503220|OTHER||Slope|-1.51||||0.007|TWO_SIDED|95.0|-2.62|-0.41||The a priori threshold for statistical significance after Bonferroni correction for multiple comparisons was p\<.0071.|Regression, Linear||Those with lower levels of baseline left amygdala response to positive picture outcomes had favorable GAD symptom improvements in BA and limited GAD symptom improvements in EXP.|Assess left amygdala response to positive picture decision outcomes as a predictor of GAD-7 symptom improvement: time x L. Amyg x treatment-arm interaction||-0.41|-2.62|.007
72487301|NCT02807480|144503220|OTHER||Slope|0.36||||0.238|TWO_SIDED|95.0|-0.24|0.97|||Regression, Linear|||Baseline approach behavior during conflict trials predicting trajectory of GAD-7 symptoms: time main effect||0.97|-0.24|0.238
72487302|NCT02807480|144503220|SUPERIORITY||Slope|-0.49||||0.262|TWO_SIDED|95.0|-1.36|0.37|||Regression, Linear|||Relationship between baseline approach behavior on conflict trials and the trajectory of GAD-7 symptoms: time x treatment interaction effect||0.37|-1.36|.262
72487303|NCT02807480|144503220|OTHER||Slope|2.37||||0.222|TWO_SIDED|95.0|-1.44|6.19|||Regression, Linear|||relationship between baseline response time on conflict trials and trajectory of GAD-7 symptoms: time main effects||6.19|-1.44|.222
72487304|NCT02807480|144503220|SUPERIORITY||Slope|-0.23||||0.942|TWO_SIDED|95.0|-6.48|6.02|||Regression, Linear|||Relationship between baseline average RT during conflict trials on the AAC and trajectory of GAD-7 symptoms: time x treatment interaction effect||6.02|-6.48|.942
72487305|NCT02807480|144503220|OTHER||Slope|-0.05||||0.932|TWO_SIDED|95.0|-1.2|1.1|||Regression, Linear|||Relationship of striatum activity during points outcomes (reward) with GAD-7 trajectory: time main effects||1.1|-1.2|.932
72487306|NCT02807480|144503220|SUPERIORITY||Slope|-0.08||||0.922|TWO_SIDED|95.0|-1.7|1.53|||Regression, Linear|||Relationship of striatum activity during points outcomes (reward) with GAD-7 trajectory: time x treatment interaction effects||1.53|-1.7|.922
72487307|NCT02807480|144503220|OTHER||Slope|0.0||||0.998|TWO_SIDED|95.0|-0.99|0.99|||Regression, Linear|||Relationship of right amygdala activity during negative images with GAD-7 trajectory: time main effects||.99|-.99|.998
72487308|NCT02807480|144503220|SUPERIORITY||Slope|-0.88||||0.234|TWO_SIDED|95.0|-2.34|0.57|||Regression, Linear|||Relationship of right amygdala activity during negative images with GAD-7 trajectory: time x treatment interaction||.57|-2.34|.234
72487309|NCT02807480|144503220|OTHER||Slope|-0.03||||0.967|TWO_SIDED|95.0|-1.53|1.47|||Regression, Linear|||Relationship of right dlPFC activity during conflict decisions with GAD-7 trajectory: time main effects||1.47|-1.53|.967
72402977|NCT01154218|144311786|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|111.32|||||TWO_SIDED|90.0|100.47|123.33||||||Natural log transformed Cmax of crizotinib was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||123.33|100.47|
72402978|NCT01154218|144311786|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|86.22|||||TWO_SIDED|90.0|77.89|95.43||||||Natural log transformed Cmax of crizotinib was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||95.43|77.89|
72487310|NCT02807480|144503220|OTHER||Slope|0.74||||0.504|TWO_SIDED|95.0|-1.43|2.91|||Regression, Linear|||Relationship of right dlPFC activity during conflict decision-making with GAD-7 trajectory: time x treatment interaction effect||2.91|-1.43|0.504
72487311|NCT02807480|144503220|OTHER||Slope|-1.68||||0.612|TWO_SIDED|95.0|-8.21|4.84|||Regression, Linear|||Change in conflict arbitration (AAC conflict RTpost-RTpre) predicting trajectories of GAD-7 scores over the 10 sessions: Time x RT\_Change interaction||4.84|-8.21|0.612
72487312|NCT02807480|144503220|SUPERIORITY||Slope|5.08||||0.259|TWO_SIDED|95.0|-3.76|13.92|||Regression, Linear|||change in conflict arbitration response time (AAC conflict RTpost-RTpre) predicting trajectories of GAD-7 scores over 10 sessions: RT\_Change x Time x Treatment interaction||13.92|-3.76|.259
72487313|NCT02807480|144503220|OTHER||Slope|-0.53||||0.209|TWO_SIDED|95.0|-1.35|0.3|||Regression, Linear|||Change in behavior (AAC conflict post-pre) in predicting trajectories of GAD-7 scores over the 10 sessions: Time x Behavior\_change interaction||0.30|-1.35|.209
72487314|NCT02807480|144503220|SUPERIORITY||Slope|1.53||||0.013|TWO_SIDED|95.0|0.33|2.73|||Regression, Linear|||Change in behavior (AAC conflict post-pre) in predicting trajectories of GAD-7 scores over the 10 sessions: Time x Behavior\_change x Treatment interaction||2.73|0.33|0.013
72514210|NCT02370498|144559148|OTHER||Hazard Ratio (HR)|1.77||||1|TWO_SIDED|95.0|1.42|2.2||One-sided p-value based on log-rank test stratified by geographic region (Europe/Israel/North America/Australia vs. Asia vs. Rest of World), TTP on first-line therapy (\< 6 months vs. \>= 6 months), and PD-L1 status (positive vs. negative).|Regression, Cox|P-value rounded to 5 decimal places.||Treatment difference in TTP was assessed by the Stratified Log-rank test, and a stratified Cox proportional hazard model with Efron's method of tie handling was used to assess the magnitude of the treatment difference (HR) between the treatment arms.||2.20|1.42|1.00000
72514211|NCT02370498|144559149|OTHER||Hazard Ratio (HR)|0.97||||0.3928|TWO_SIDED|95.0|0.77|1.23||One-sided p-value based on log-rank test stratified by geographic region (Europe/Israel/North America/Australia vs. Asia vs. Rest of World) and TTP on first-line therapy (\<6 months vs. ≥6 months).|Regression, Cox|P-value rounded to 5 decimal places.||Treatment difference in TTP was assessed by the Stratified Log-rank test, and a stratified Cox proportional hazard model with Efron's method of tie handling was used to assess the magnitude of the treatment difference (HR) between the treatment arms.||1.23|0.77|0.39280
72514212|NCT02370498|144559150|OTHER||Hazard Ratio (HR)|1.21||||0.97033|TWO_SIDED|95.0|1.0|1.47||One-sided p-value based on log-rank test stratified by geographic region (Europe/Israel/North America/Australia vs. Asia vs. Rest of World), TTP on first-line therapy (\< 6 months vs. \>= 6 months), and PD-L1 status (positive vs. negative).|Regression, Cox|P-value rounded to 5 decimal places.||Treatment difference in TTP was assessed by the Stratified Log-rank test, and a stratified Cox proportional hazard model with Efron's method of tie handling was used to assess the magnitude of the treatment difference (HR) between the treatment arms.||1.47|1.00|0.97033
72567962|NCT02037165|144667470|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.54|STANDARD_ERROR_OF_MEAN|1.2418|||TWO_SIDED|95.0|-3.0|1.9|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 22:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||1.9|-3.0|
72402979|NCT01154218|144311789|SUPERIORITY_OR_OTHER||Ratio of Adjusted means|100.03|||||TWO_SIDED|90.0|90.16|110.97||||||Natural log transformed AUClast of PF-06260182 was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||110.97|90.16|
72487315|NCT02807480|144503221|OTHER||Slope|-2.95||||0.006|TWO_SIDED|95.0|-5.06|-0.84||The a priori threshold for statistical significance after Bonferroni correction for multiple comparisons was p\<.0125.|Regression, Linear|||Baseline emotional conflict, a computational parameter reflecting avoidance relative to reward value, as a predictor of the linear trajectory of symptom change over time: time x EC interaction||-0.84|-5.06|0.006
72487316|NCT02807480|144503221|OTHER||Slope|-1.02||||0.003|TWO_SIDED|95.0|-1.68|-0.36|||Regression, Linear|||Assess avoidance behavior on conflict trials as a predictor of PROMIS Anxiety symptom improvement: time x avoidance interaction||-0.36|-1.68|0.003
72487317|NCT02807480|144503221|OTHER||Slope|-1.88||||0.007|TWO_SIDED|95.0|-2.89|-0.87||The a priori threshold for statistical significance after Bonferroni correction for multiple comparisons was p\<.0071.|Regression, Linear|||Assess left dlPFC response to baseline negative picture decision outcomes as a predictor of PROMIS Anxiety symptom improvement: time x L. dlPFC interaction||-0.87|-2.89|.007
72487318|NCT02807480|144503221|OTHER||Slope|1.02||||0.003|TWO_SIDED|95.0|0.36|1.68|||Regression, Linear|||Relationships between baseline average approach behavior during conflict trials on the AAC and trajectory of PROMIS Anxiety symptoms||1.68|0.36|.003
72402980|NCT01154218|144311789|SUPERIORITY_OR_OTHER||Ratio of Adjusted means|108.85|||||TWO_SIDED|90.0|98.11|120.77||||||Natural log transformed AUClast of PF-06260182 was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||120.77|98.11|
72402981|NCT01154218|144311789|SUPERIORITY_OR_OTHER||Ratio of Adjusted means|74.87|||||TWO_SIDED|90.0|67.55|82.98||||||Natural log transformed AUClast of PF-06260182 was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||82.98|67.55|
72487319|NCT02807480|144503221|SUPERIORITY||Slope|-0.54||||0.258|TWO_SIDED|95.0|-1.48|0.4|||Regression, Linear|||Relationships between baseline average approach behavior during conflict trials on the AAC and trajectory of PROMIS Anxiety symptoms: time x treatment x approach behavior interaction||0.4|-1.48|.258
72487320|NCT02807480|144503221|OTHER||Slope|1.3||||0.56|TWO_SIDED|95.0|-3.08|5.69|||Regression, Linear|||Relationships between baseline average RT during conflict trials on the AAC and trajectory of PROMIS Anxiety symptoms: time x approach behavior interaction||5.69|-3.08|.56
72514213|NCT02370498|144559151|OTHER||Difference in Percentage|2.0||||0.28967|TWO_SIDED|95.0|-5.0|9.1||Stratification factors for MN method included geographic region (Europe/Israel/North America/Australia vs. Asia vs. Rest of World) and TTP on first-line therapy (\<6 months vs. ≥6 months) weighting by sample size.|Miettinen and Nurminen method|P-value rounded to 5 decimal places.||Stratified Miettinen and Nurminen's (MN) method was used for comparison of the ORR between the treatment arms. A 95% CI for the difference in response rates between the pembrolizumab arm and paclitaxel arm was provided.||9.1|-5.0|0.28967
72487321|NCT02807480|144503221|SUPERIORITY||Slope|-1.77||||0.629|TWO_SIDED|95.0|-8.95|5.41|||Regression, Linear|||Relationships between baseline average RT (response time) during conflict trials on the AAC and trajectory of PROMIS Anxiety symptoms: time x treatment x RT interaction||5.41|-8.95|.629
72487322|NCT02807480|144503221|OTHER||Slope|-0.21||||0.75|TWO_SIDED|95.0|-1.51|1.09|||Regression, Linear|||Relationship of striatum activity during points outcomes (reward) with PROMIS ANXIETY trajectory: time x striatum interaction effects||1.09|-1.51|0.75
72487323|NCT02807480|144503221|SUPERIORITY||Slope|1.27||||0.169|TWO_SIDED|95.0|-0.54|3.09|||Regression, Linear|||Relationship of striatum activity during points outcomes (reward) with PROMIS Anxiety trajectory: time x treatment x striatum interaction effects||3.09|-0.54|.169
72487324|NCT02807480|144503221|OTHER||Slope|0.15||||0.792|TWO_SIDED|95.0|-1.0|1.31|||Regression, Linear|||Relationship of right amygdala activity during negative images with PROMIS Anxiety trajectory: time x amygdala interaction||1.31|-1.00|0.792
72487325|NCT02807480|144503221|SUPERIORITY||Slope|-0.73||||0.396|TWO_SIDED|95.0|-2.41|0.96|||Regression, Linear|||Relationship of right amygdala activity during negative images with PROMIS Anxiety trajectory: time x treatment amygdala interaction||0.96|-2.41|.396
72487326|NCT02807480|144503221|OTHER||Slope|-1.55||||0.009|TWO_SIDED|95.0|-2.7|-0.4|||Regression, Linear|||Relationship of right dlPFC activity during negative images with PROMIS Anxiety trajectory: time x dlPFC interaction||-0.4|-2.7|.009
72514214|NCT02370498|144559152|OTHER||Difference in Percentage|-1.3||||0.6901|TWO_SIDED|95.0|-6.5|4.0||Stratification factors for MN method included geographic region (Europe/Israel/North America/Australia vs. Asia vs. Rest of World), TTP on first-line therapy (\<6 months vs. ≥6 months), and PD-L1 status (positive vs. negative) weighting by sample size|Miettinen and Nurminen method|P-value rounded to 5 decimal places.||Stratified MN method was used for comparison of the ORR between the treatment arms. A 95% CI for the difference in response rates between the pembrolizumab arm and paclitaxel arm was provided.||4.0|-6.5|0.69010
72402982|NCT01154218|144311790|SUPERIORITY_OR_OTHER||Ratio of Adjusted means|100.08|||||TWO_SIDED|90.0|90.46|110.73||||||Natural log transformed AUC (0-∞) of PF-06260182 was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||110.73|90.46|
72514215|NCT02370498|144559153|OTHER||Difference in Percentage|1.6||||0.3322|TWO_SIDED|95.0|-5.8|9.1||Stratification factors for MN method included geographic region (Europe/Israel/North America/Australia vs. Asia vs. Rest of World) and TTP on first-line therapy (\<6 months vs. ≥6 months), weighting by sample size.|Miettinen and Nurminen method|P-value rounded to 5 decimal places.||Stratified MN method was used for comparison of the ORR between the treatment arms. A 95% CI for the difference in response rates between the pembrolizumab arm and paclitaxel arm was provided.||9.1|-5.8|0.33220
72487327|NCT02807480|144503221|SUPERIORITY||Slope|0.28||||0.724|TWO_SIDED|95.0|-1.28|1.84|||Regression, Linear|||Relationship of right dlPFC activity during negative images with PROMIS Anxiety trajectory: time x treatment dlPFC interaction||1.84|-1.28|0.724
72487328|NCT02807480|144503221|OTHER||Slope|-4.99||||0.209|TWO_SIDED|95.0|-12.79|2.8|||Regression, Linear|||Change in conflict arbitration response time (AAC conflict RT post-pre) predicting trajectories of GAD-7 scores over the 10 sessions: Time x RT\_change interaction||2.80|-12.79|.209
72487329|NCT02807480|144503221|SUPERIORITY||Slope|12.68||||0.017|TWO_SIDED|95.0|2.23|23.13|||Regression, Linear|||Change in conflict arbitration response time (AAC conflict RT post-pre) predicting trajectories of GAD-7 scores over the 10 sessions: Time x Treatment x RT\_change interaction||23.13|2.23|0.017
72487330|NCT02807480|144503221|OTHER||Slope|-0.58||||0.259|TWO_SIDED|95.0|-1.59|0.43|||Regression, Linear|||Change in behavior (AAC conflict post-pre) predicting trajectories of GAD-7 scores over the 10 sessions: Time x Behavior\_change interaction||0.43|-1.59|.259
72487331|NCT02807480|144503221|OTHER||Slope|1.07||||0.15|TWO_SIDED|95.0|-0.39|2.54|||Regression, Linear|||Change in behavior (AAC conflict post-pre) predicting trajectories of GAD-7 scores over the 10 sessions: Time x Treatment x Behavior\_change interaction||2.54|-0.39|.150
72487332|NCT02807480|144503222|OTHER||Slope|-3.52||||0.001|TWO_SIDED|95.0|-5.57|-1.47||The a priori threshold for statistical significance after Bonferroni correction for multiple comparisons was p\<.0125.|Regression, Linear|||Assess emotional conflict, a computational parameter reflecting avoidance relative to reward value, as a predictor of PROMIS Depression scores. Time x EC interaction.||-1.47|-5.57|0.001
72567963|NCT02037165|144667470|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.12|STANDARD_ERROR_OF_MEAN|1.2419|||TWO_SIDED|95.0|-3.6|1.3|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 24:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||1.3|-3.6|
72567964|NCT02037165|144667470|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.29|STANDARD_ERROR_OF_MEAN|1.2344|||TWO_SIDED|95.0|-3.7|1.1|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 0:30h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||1.1|-3.7|
72567965|NCT02037165|144667470|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.89|STANDARD_ERROR_OF_MEAN|1.2343|||TWO_SIDED|95.0|-4.3|0.5|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 1:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||0.5|-4.3|
72567966|NCT02037165|144667470|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.16|STANDARD_ERROR_OF_MEAN|1.2343|||TWO_SIDED|95.0|-3.6|1.3|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 2:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||1.3|-3.6|
72567967|NCT02037165|144667470|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.09|STANDARD_ERROR_OF_MEAN|1.2343|||TWO_SIDED|95.0|-2.3|2.5|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 3:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||2.5|-2.3|
72567968|NCT02037165|144667470|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.72|STANDARD_ERROR_OF_MEAN|1.2343|||TWO_SIDED|95.0|-3.1|1.7|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 4:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||1.7|-3.1|
72567969|NCT02037165|144667470|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.42|STANDARD_ERROR_OF_MEAN|1.2343|||TWO_SIDED|95.0|-2.0|2.8|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 5:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||2.8|-2.0|
72567970|NCT02037165|144667470|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.13|STANDARD_ERROR_OF_MEAN|1.2343|||TWO_SIDED|95.0|-2.3|2.6|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 6:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||2.6|-2.3|
72567971|NCT02037165|144667470|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.71|STANDARD_ERROR_OF_MEAN|1.2343|||TWO_SIDED|95.0|-4.1|0.7|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 22:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||0.7|-4.1|
72487333|NCT02807480|144503222|OTHER||Slope|-1.93|||<|0.001|TWO_SIDED|95.0|-2.91|-0.95||The a priori threshold for statistical significance after Bonferroni correction for multiple comparisons was p\<.0125.|Regression, Linear|||Baseline left dlPFC response to negative pictures as a predictor of PROMIS depression symptom improvement: time x L. dlFPC interaction.||-0.95|-2.91|<.001
72514216|NCT02370498|144559154|OTHER||Difference in Percentage|-3.0||||0.85922|TWO_SIDED|95.0|-8.5|2.6||Stratification factors included geographic region (Europe/Israel/North America/Australia vs. Asia vs. Rest of World), TTP on first-line therapy (\<6 months vs. ≥6 months), and PD-L1 status (positive vs. negative) weighting by sample size.|Miettinen and Nurminen method|P-value rounded to 5 decimal places.||Stratified Miettinen and Nurminen's method was used for comparison of the ORR between the treatment arms. A 95% CI for the difference in response rates between the pembrolizumab arm and paclitaxel arm is provided.||2.6|-8.5|0.85922
72514217|NCT02370498|144559160|OTHER||Difference in Percentage|-3.2|||||TWO_SIDED|95.0|-6.9|0.2||||||Between-treatment differences (Pembrolizumab vs. Paclitaxel) in the percentage of participants with events and accompanying 95% confidence intervals were based on the Miettinen and Nurminen method. Negative values correspond to a greater percentage of events for Paclitaxel.||0.2|-6.9|
72514218|NCT01122030|144559164|SUPERIORITY_OR_OTHER|||||||0.0767||95.0|||||ANCOVA|P-values are from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of SBMs as a covariate.||||||0.0767
72514219|NCT01122030|144559164|SUPERIORITY_OR_OTHER|||||||0.8727||95.0|||||ANCOVA|P-values are from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of SBMs as a covariate.||||||0.8727
72514220|NCT01122030|144559164|SUPERIORITY_OR_OTHER|||||||0.6373||95.0|||||ANCOVA|P-values are from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of SBMs as a covariate.||||||0.6373
72514221|NCT01122030|144559164|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|P-values are from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of SBMs as a covariate.||||||<0.0001
72514222|NCT01122030|144559164|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|P-values are from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of SBMs as a covariate.||||||<0.0001
72567972|NCT02037165|144667470|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.18|STANDARD_ERROR_OF_MEAN|1.2344|||TWO_SIDED|95.0|-3.6|1.2|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 24:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||1.2|-3.6|
72567973|NCT02037165|144667471|SUPERIORITY_OR_OTHER||adjusted mean difference|0.79|STANDARD_ERROR_OF_MEAN|1.1758|||TWO_SIDED|95.0|-1.5|3.1|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 0:30h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||3.1|-1.5|
72567974|NCT02037165|144667471|SUPERIORITY_OR_OTHER||adjusted mean difference|0.51|STANDARD_ERROR_OF_MEAN|1.1755|||TWO_SIDED|95.0|-1.8|2.8|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 1:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||2.8|-1.8|
72567975|NCT02037165|144667471|SUPERIORITY_OR_OTHER||adjusted mean difference|2.06|STANDARD_ERROR_OF_MEAN|0.1752|||TWO_SIDED|95.0|-0.2|4.4|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 2:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||4.4|-0.2|
72567976|NCT02037165|144667471|SUPERIORITY_OR_OTHER||adjusted mean difference|1.33|STANDARD_ERROR_OF_MEAN|1.1751|||TWO_SIDED|95.0|-1.0|3.6|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 3:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||3.6|-1.0|
72567977|NCT02037165|144667471|SUPERIORITY_OR_OTHER||adjusted mean difference|1.12|STANDARD_ERROR_OF_MEAN|1.175|||TWO_SIDED|95.0|-1.2|3.4|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 4:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||3.4|-1.2|
72514223|NCT01122030|144559164|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|P-values are from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of SBMs as a covariate.||||||<0.0001
72402983|NCT01154218|144311790|SUPERIORITY_OR_OTHER||Ratio of Adjusted means|108.47|||||TWO_SIDED|90.0|98.03|120.02||||||Natural log transformed AUC (0-∞) of PF-06260182 was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||120.02|98.03|
72402984|NCT01154218|144311790|SUPERIORITY_OR_OTHER||Ratio of Adjusted means|76.59|||||TWO_SIDED|90.0|69.23|84.74||||||Natural log transformed AUC (0-∞) of PF-06260182 was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||84.74|69.23|
72402985|NCT01154218|144311791|SUPERIORITY_OR_OTHER||Ratio of Adjusted means|102.11|||||TWO_SIDED|90.0|92.84|112.31||||||Natural log transformed Cmax of PF-06260182 was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||112.31|92.84|
72402986|NCT01154218|144311791|SUPERIORITY_OR_OTHER||Ratio of Adjusted means|108.87|||||TWO_SIDED|90.0|98.98|119.75||||||Natural log transformed Cmax of PF-06260182 was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||119.75|98.98|
72402987|NCT01154218|144311791|SUPERIORITY_OR_OTHER||Ratio of Adjusted means|71.94|||||TWO_SIDED|90.0|65.46|79.05||||||Natural log transformed Cmax of PF-06260182 was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||79.05|65.46|
72487334|NCT02807480|144503222|OTHER||Slope|-2.02||||0.036|TWO_SIDED|95.0|-3.9|-0.13||Threshold for statistical significance is 0.05.|Regression, Linear|||Baseline striatum response to monetary outcomes as a predictor of improvement in depressive symptoms: time x treatment x striatum interaction.||-0.13|-3.9|.036
72514224|NCT01122030|144559165|SUPERIORITY_OR_OTHER|||||||0.8982||95.0|||||ANCOVA|P-values are from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of SBMs as a covariate.||||||0.8982
72577039|NCT00261443|144680753|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.04||||0.222|TWO_SIDED|95.0|-0.03|0.11||ANOVA model, controlling for treatment and mood stabilizer, is used for baseline. ANCOVA model, controlling for treatment, mood stabilizer, and baseline value, is used for mean change from baseline.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences and p-values are based on the ANOVA/ANCOVA model.||Highest Value of Change Treatment Difference||0.11|-0.03|0.222
72402988|NCT01358357|144311840|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.71|||<|0.078|TWO_SIDED|95.0|0.49|1.04||A hazard ratio of time to recurrence and its corresponding 95% Wald CI were estimated for the lurasidone arm vs.placebo arm, using a Cox proportional hazards model.Cox model included treatment effect as fixed effect, and stratified by pooled country.|Cox Proportional Hazards Model|||It was assumed that the recurrence event rates during the double-blind phase were to be 24% and 39% for subjects treated with lurasidone and placebo, respectively. A total of 120 recurrence events were required to achieve 90% power to detect the 15% difference in subjects who had a recurrence event during the double-blind phase between the treatment groups using a log-rank test with two sided alpha level of 0.05.||1.04|0.49|<0.078
72487335|NCT02807480|144503222|OTHER||Slope|-1.21|||<|0.001|TWO_SIDED|95.0|-1.85|-0.58||The a priori threshold for statistical significance after Bonferroni correction for multiple comparisons was p\<.0125.|Regression, Linear|||Relationships between baseline average approach behavior during conflict trials on the AAC and trajectory of PROMIS Depression symptoms: time x approach behavior interaction||-0.58|-1.85|<.001
72514225|NCT01122030|144559165|SUPERIORITY_OR_OTHER|||||||0.4946||95.0|||||ANCOVA|P-values are from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of SBMs as a covariate.||||||0.4946
72514226|NCT01122030|144559165|SUPERIORITY_OR_OTHER|||||||0.9301||95.0|||||ANCOVA|P-values are from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of SBMs as a covariate.||||||0.9301
72514227|NCT01122030|144559165|SUPERIORITY_OR_OTHER|||||||0.0047||95.0|||||ANCOVA|P-values are from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of SBMs as a covariate.||||||0.0047
72402989|NCT01358357|144311841|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.72|||<|0.034|TWO_SIDED|95.0|0.54|0.98||A HR of time to discontinuation and corresponding 95% Wald CI were est. for lurasidone arm vs.the placebo arm, using a Cox proportional hazards model. Model included treatment effect including treatment as a fixed effect,stratified by pooled country.|Cox Proportional Hazards Model|||||0.98|0.54|<0.034
72402990|NCT01358357|144311842|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.72||||0.113|TWO_SIDED|95.0|0.48|1.08||A HR of time to recurrence and its corresponding 95% Wald CI were estimated for lurasidone arm vs. placebo arm,using a Cox proportional hazards model. Model included treatment effect including treatment as a fixed effect stratified by pooled country.|Cox Proportional hazard Model|||||1.08|0.48|0.113
72402991|NCT01358357|144311844|SUPERIORITY_OR_OTHER||LS mean difference lurasidone vs.Placebo|-0.09||||0.406|TWO_SIDED|95.0|-0.29|0.12||analysis of ANCOVA model contains treatment ,pooled country, and mood stabilizer (lithium or divalproex) as fixed factors and baseline as a covariate.|ANCOVA|||||0.12|-0.29|0.406
72402992|NCT01358357|144311845|SUPERIORITY_OR_OTHER||LS mean difference lurasidone vs.Placebo|-0.11||||0.162|TWO_SIDED|95.0|-0.26|0.04||Analysis of Covariance (ANCOVA) model contains treatment, and pooled country, and mood stabilizer (lithium or divalproex) as fixed factors and baseline as a covariate.|ANCOVA|||||0.04|-0.26|0.162
72487336|NCT02807480|144503222|SUPERIORITY||Slope|-0.91||||0.049|TWO_SIDED|95.0|-1.81|0.0|||Regression, Linear|||Relationships between baseline average approach behavior during conflict trials on the AAC and trajectory of PROMIS Depression symptoms: time x treatment x approach behavior interaction||0.00|-1.81|.049
72514228|NCT01122030|144559165|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|P-values are from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of SBMs as a covariate.||||||<0.0001
72487337|NCT02807480|144503222|OTHER||Slope|0.6||||0.778|TWO_SIDED|95.0|-3.6|4.81|||Regression, Linear|||Relationships between baseline average RT during conflict trials on the AAC and trajectory of PROMIS Depression symptoms: time x RT interaction||4.81|-3.6|.778
72514229|NCT01122030|144559165|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|P-values are from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of SBMs as a covariate.||||||<0.0001
72514230|NCT01122030|144559166|SUPERIORITY_OR_OTHER|||||||0.1334||95.0|||||ANCOVA|P-value is from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of BMs as a covariate.||||||0.1334
72514231|NCT01122030|144559166|SUPERIORITY_OR_OTHER|||||||0.332||95.0|||||ANCOVA|P-value is from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of BMs as a covariate.||||||0.3320
72514232|NCT01122030|144559166|SUPERIORITY_OR_OTHER|||||||0.9371||95.0|||||ANCOVA|P-value is from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of BMs as a covariate.||||||0.9371
72514233|NCT01122030|144559166|SUPERIORITY_OR_OTHER|||||||0.0002||95.0|||||ANCOVA|P-value is from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of BMs as a covariate.||||||0.0002
72514234|NCT01122030|144559166|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|P-value is from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of BMs as a covariate.||||||<0.0001
72514235|NCT01122030|144559166|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|P-value is from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of BMs as a covariate.||||||<0.0001
72514236|NCT01122030|144559167|SUPERIORITY_OR_OTHER|||||||0.7978||95.0|||||ANCOVA|P-values are from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of BMs as a covariate.||||||0.7978
72514237|NCT01122030|144559167|SUPERIORITY_OR_OTHER|||||||0.7143||95.0|||||ANCOVA|P-values are from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of BMs as a covariate.||||||0.7143
72514238|NCT01122030|144559167|SUPERIORITY_OR_OTHER|||||||0.7531||95.0|||||ANCOVA|P-values are from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of BMs as a covariate.||||||0.7531
72514239|NCT01122030|144559167|SUPERIORITY_OR_OTHER|||||||0.0283||95.0|||||ANCOVA|P-values are from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of BMs as a covariate.||||||0.0283
72514240|NCT01122030|144559167|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|P-values are from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of BMs as a covariate.||||||<0.0001
72514241|NCT01122030|144559167|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|P-values are from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of BMs as a covariate.||||||<0.0001
72514242|NCT01122030|144559168|SUPERIORITY_OR_OTHER|||||||0.6269||95.0|||||ANCOVA|P-values are from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of CSBMs as a covariate.||||||0.6269
72514243|NCT01122030|144559168|SUPERIORITY_OR_OTHER|||||||0.7456||95.0|||||ANCOVA|P-values are from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of CSBMs as a covariate.||||||0.7456
72514244|NCT01122030|144559168|SUPERIORITY_OR_OTHER|||||||0.1968||95.0|||||ANCOVA|P-values are from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of CSBMs as a covariate.||||||0.1968
72514245|NCT01122030|144559168|SUPERIORITY_OR_OTHER|||||||0.8708||95.0|||||ANCOVA|P-values are from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of CSBMs as a covariate.||||||0.8708
72514246|NCT01122030|144559168|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|P-values are from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of CSBMs as a covariate.||||||<0.0001
72514247|NCT01122030|144559168|SUPERIORITY_OR_OTHER|||||||0.0002||95.0|||||ANCOVA|P-values are from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of CSBMs as a covariate.||||||0.0002
72514248|NCT01122030|144559169|SUPERIORITY_OR_OTHER|||||||0.6131||95.0|||||ANCOVA|P-values are from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of CSBMs as a covariate.||||||0.6131
72514249|NCT01122030|144559169|SUPERIORITY_OR_OTHER|||||||0.9293||95.0|||||ANCOVA|P-values are from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of CSBMs as a covariate.||||||0.9293
72514250|NCT01122030|144559169|SUPERIORITY_OR_OTHER|||||||0.799||95.0|||||ANCOVA|P-values are from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of CSBMs as a covariate.||||||0.7990
72514251|NCT01122030|144559169|SUPERIORITY_OR_OTHER|||||||0.7674||95.0|||||ANCOVA|P-values are from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of CSBMs as a covariate.||||||0.7674
72487338|NCT02807480|144503222|SUPERIORITY||Slope|1.38||||0.696|TWO_SIDED|95.0|-5.56|8.31|||Regression, Linear|||Relationships between baseline average RT during conflict trials on the AAC and trajectory of PROMIS Depression symptoms: time x treatment x RT interaction||8.31|-5.56|.696
72514252|NCT01122030|144559169|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|P-values are from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of CSBMs as a covariate.||||||<0.0001
72514253|NCT01122030|144559169|SUPERIORITY_OR_OTHER|||||||0.0018||95.0|||||ANCOVA|P-values are from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of CSBMs as a covariate.||||||0.0018
72514254|NCT01122030|144559170|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.29||||0.7434|TWO_SIDED|95.0|0.42|3.92|||Log Rank|P-values were obtained from the log-rank test stratified by Gender.||||3.92|0.42|0.7434
72514255|NCT01122030|144559170|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.54||||0.4449|TWO_SIDED|95.0|0.54|4.42|||Log Rank|P-values were obtained from the log-rank test stratified by Gender.||||4.42|0.54|0.4449
72514256|NCT01122030|144559170|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.86||||0.8129|TWO_SIDED|95.0|0.27|2.72|||Log Rank|P-values were obtained from the log-rank test stratified by Gender.||||2.72|0.27|0.8129
72487339|NCT02807480|144503222|OTHER||Slope|0.44||||0.503|TWO_SIDED|95.0|-0.84|1.71|||Regression, Linear|||Relationship of striatum activity during points outcomes (reward) with PROMIS Depression trajectory: time x striatum interaction effects||1.71|-0.84|.503
72402993|NCT01358357|144311846|SUPERIORITY_OR_OTHER||LS mean difference lurasidone vs.Placebo|-0.07||||0.496|TWO_SIDED|95.0|-0.27|0.13||Analysis of covariance (ANCOVA) model contains treatment, and pooled country, and mood stabilizer (lithium or divalproex) as fixed factors and baseline as a covariate.|ANCOVA|||||0.13|-0.27|0.496
72514257|NCT01122030|144559170|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|7.52||||0.0005|TWO_SIDED|95.0|2.29|24.72|||Log Rank|P-values were obtained from the log-rank test stratified by Gender.||||24.72|2.29|0.0005
72514258|NCT01122030|144559170|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|9.93|||<|0.0001|TWO_SIDED|95.0|3.09|31.89|||Log Rank|P-values were obtained from the log-rank test stratified by Gender.||||31.89|3.09|<0.0001
72514259|NCT01122030|144559170|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|202272814.0|||<|0.0001||95.0|||||Log Rank|P-values were obtained from the log-rank test stratified by Gender.|Hazard Ratio is infinite due to small range of observed times in 3 mg group that has no overlap with the Placebo group.|||||<0.0001
72514260|NCT01122030|144559171|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.51||||0.4923|TWO_SIDED|95.0|0.53|4.28|||Log Rank|P-values are from the log rank test stratified by gender.||||4.28|0.53|0.4923
72514261|NCT01122030|144559171|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.45||||0.5479|TWO_SIDED|95.0|0.52|4.06|||Log Rank|P-values are from the log rank test stratified by gender.||||4.06|0.52|0.5479
72514262|NCT01122030|144559171|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.44||||0.506|TWO_SIDED|95.0|0.56|3.67|||Log Rank|P-values are from the log rank test stratified by gender.||||3.67|0.56|0.5060
72514263|NCT01122030|144559171|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|7.36||||0.0005|TWO_SIDED|95.0|2.27|23.9|||Log Rank|P-values are from the log rank test stratified by gender.||||23.90|2.27|0.0005
72514264|NCT01122030|144559171|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|9.54|||<|0.0001|TWO_SIDED|95.0|3.0|30.35|||Log Rank|P-values are from the log rank test stratified by gender.||||30.35|3.00|<0.0001
72514265|NCT01122030|144559171|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|192233779.0|||<|0.0001||95.0|||||Log Rank|P-values are from the log rank test stratified by gender.|Hazard Ratio is infinite due to small range of observed times in 3 mg group that has no overlap with the Placebo group.|||||<0.0001
72514266|NCT01122030|144559172|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|3.45||||0.1523|TWO_SIDED|95.0|0.62|19.35|||Log Rank|P-values are from the log rank test stratified by gender.||||19.35|0.62|0.1523
72514267|NCT01122030|144559172|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|4.55||||0.0856|TWO_SIDED|95.0|0.76|27.07|||Log Rank|P-values are from the log rank test stratified by gender.||||27.07|0.76|0.0856
72514268|NCT01122030|144559172|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.81||||0.5284|TWO_SIDED|95.0|0.3|10.98|||Log Rank|P-values are from the log rank test stratified by gender.||||10.98|0.30|0.5284
72514269|NCT01122030|144559172|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.86||||0.8594|TWO_SIDED|95.0|0.09|8.66|||Log Rank|P-values are from the log rank test stratified by gender.||||8.66|0.09|0.8594
72514270|NCT01122030|144559172|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|59.34|||<|0.0001|TWO_SIDED|95.0|6.55|537.38|||Log Rank|P-values are from the log rank test stratified by gender.||||537.38|6.55|<0.0001
72514271|NCT01122030|144559172|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|10.99||||0.0007|TWO_SIDED|95.0|2.3|52.57|||Log Rank|P-values are from the log rank test stratified by gender.||||52.57|2.30|0.0007
72514272|NCT01122030|144559174|SUPERIORITY_OR_OTHER|||||||0.5054||95.0|||||ANCOVA|P-values were obtained from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of CBMs as a covariate.||||||0.5054
72514273|NCT01122030|144559174|SUPERIORITY_OR_OTHER|||||||0.9688||95.0|||||ANCOVA|P-values were obtained from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of CBMs as a covariate.||||||0.9688
72514274|NCT01122030|144559174|SUPERIORITY_OR_OTHER|||||||0.6963||95.0|||||ANCOVA|P-values were obtained from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of CBMs as a covariate.||||||0.6963
72514275|NCT01122030|144559174|SUPERIORITY_OR_OTHER|||||||0.9599||95.0|||||ANCOVA|P-values were obtained from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of CBMs as a covariate.||||||0.9599
72514276|NCT01122030|144559174|SUPERIORITY_OR_OTHER|||||||0.0001||95.0|||||ANCOVA|P-values were obtained from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of CBMs as a covariate.||||||0.0001
72402994|NCT01358357|144311847|SUPERIORITY_OR_OTHER||LS mean difference|-0.8||||0.128|TWO_SIDED|95.0|-1.8|0.2||Analysis of Covariance (ANCOVA) model contains treatment, and pool country, and mood stabilizer (lithium or divalproex) as fixed factors and baseline as a covariate.|ANCOVA|||||0.2|-1.8|0.128
72402995|NCT01358357|144311848|SUPERIORITY_OR_OTHER||LS mean difference lurasdione vs.Placebo|-0.5||||0.485|TWO_SIDED|95.0|-1.9|0.9||Analysis of Covariance (ANCOVA) model contains treatment, and pooled country, and mood stabilizer (lithium or divalproex) as fixed factors and baseline as a covariate.|ANCOVA|||||0.9|-1.9|0.485
72514277|NCT01122030|144559174|SUPERIORITY_OR_OTHER|||||||0.0006||95.0|||||ANCOVA|P-values were obtained from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of CBMs as a covariate.||||||0.0006
72514278|NCT01122030|144559175|SUPERIORITY_OR_OTHER|||||||0.3441||95.0|||||ANCOVA|P-values were obtained from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of CBMs as a covariate.||||||0.3441
72514279|NCT01122030|144559175|SUPERIORITY_OR_OTHER|||||||0.7159||95.0||||P-values were obtained from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of CBMs as a covariate.|ANCOVA|||||||0.7159
72514280|NCT01122030|144559175|SUPERIORITY_OR_OTHER|||||||0.7342||95.0|||||ANCOVA|P-values were obtained from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of CBMs as a covariate.||||||0.7342
72514281|NCT01122030|144559175|SUPERIORITY_OR_OTHER|||||||0.8714||95.0|||||ANCOVA|P-values were obtained from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of CBMs as a covariate.||||||0.8714
72514282|NCT01122030|144559175|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|P-values were obtained from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of CBMs as a covariate.||||||<0.0001
72514283|NCT01122030|144559175|SUPERIORITY_OR_OTHER|||||||0.0006||95.0|||||ANCOVA|P-values were obtained from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of CBMs as a covariate.||||||0.0006
72514284|NCT03943953|144559199|SUPERIORITY||Mean Difference (Final Values)|2.86||||0.018|TWO_SIDED||||||t-test, 1 sided|||This is a comparison between Time 1 and Time 2||||.018
72487340|NCT02807480|144503222|OTHER||Slope|-0.9||||0.114|TWO_SIDED|95.0|-2.02|0.22|||Regression, Linear|||Relationship of right amygdala activity during negative images with PROMIS Depression trajectory: time x amygdala interaction||.22|-2.02|.114
72402996|NCT01358357|144311849|SUPERIORITY_OR_OTHER||LS mean difference|-0.2||||0.582|TWO_SIDED|95.0|-0.8|0.5||Analysis of Covariance (ANCOVA) model contains treatment, and pooled country, and mood stabilizer (lithium or divalproex) as fixed factors and baseline as a covariate.|ANCOVA|||||0.5|-0.8|0.582
72487341|NCT02807480|144503222|SUPERIORITY||Slope|0.48||||0.561|TWO_SIDED|95.0|-1.15|2.11|||Regression, Linear|||Relationship of right amygdala activity during negative images with PROMIS Depression trajectory: time x treatment amygdala interaction||2.11|-1.15|.561
72487342|NCT02807480|144503222|OTHER||Slope|-1.54||||0.007|TWO_SIDED|95.0|-2.66|-0.42|||Regression, Linear|||Relationship of right dlPFC activity during negative images with PROMIS Depression trajectory: time x dlPFC interaction||-0.42|-2.66|.007
72487343|NCT02807480|144503222|SUPERIORITY||Slope|0.65||||0.403|TWO_SIDED|95.0|-0.87|2.17|||Regression, Linear|||Relationship of right dlPFC activity during negative images with PROMIS Depression trajectory: time x treatment dlPFC interaction||2.17|-0.87|0.403
72487344|NCT02807480|144503222|OTHER||Slope|-1.51||||0.681|TWO_SIDED|95.0|-8.76|5.73|||Regression, Linear|||Change in conflict arbitration response time (AAC conflict RT post-pre) predicting trajectories of GAD-7 scores over the 10 sessions: Time x RT\_change interaction||5.73|-8.76|0.681
72487345|NCT02807480|144503222|SUPERIORITY||Slope|5.61||||0.264|TWO_SIDED|95.0|-4.24|15.46|||Regression, Linear|||Change in conflict arbitration response time (AAC conflict RT post-pre) predicting trajectories of GAD-7 scores over the 10 sessions: Time x Treatment x RT\_change interaction||15.46|-4.24|.264
72487346|NCT02807480|144503222|OTHER||Slope|-0.43||||0.367|TWO_SIDED|95.0|-1.38|0.51|||Regression, Linear|||Change in behavior (AAC conflict post-pre) predicting trajectories of GAD-7 scores over the 10 sessions: Time x Behavior\_change interaction||0.51|-1.38|.367
72487347|NCT02807480|144503222|OTHER||Slope|0.88||||0.211|TWO_SIDED|95.0|-0.5|2.25|||Regression, Linear|||Change in behavior (AAC conflict post-pre) predicting trajectories of GAD-7 scores over the 10 sessions: Time x Treatment x Behavior\_change interaction||2.25|-0.50|.211
72487348|NCT02807480|144503223|OTHER||Slope|0.74||||0.028|TWO_SIDED|95.0|0.08|1.41|||Regression, Linear|||Relationships between baseline average approach behavior during conflict trials on the AAC and trajectory of SDS score: time x approach behavior interaction||1.41|0.08|0.028
72487349|NCT02807480|144503223|SUPERIORITY||Slope|-0.55||||0.251|TWO_SIDED|95.0|-1.49|0.39|||Regression, Linear|||Relationships between baseline average approach behavior during conflict trials on the AAC and trajectory of SDS symptoms: time x treatment x approach behavior interaction||0.39|-1.49|0.251
72487350|NCT02807480|144503223|OTHER||Slope|-0.26||||0.902|TWO_SIDED|95.0|-4.49|3.96|||Regression, Linear|||Relationships between baseline average RT during conflict trials on the AAC and trajectory of SDS symptoms: time x RT interaction||3.96|-4.49|0.902
72487351|NCT02807480|144503223|SUPERIORITY||Slope|2.23||||0.519|TWO_SIDED|95.0|-4.55|9.01|||Regression, Linear|||Relationships between baseline average RT during conflict trials on the AAC and trajectory of SDS symptoms: time x treatment x RT interaction||9.01|-4.55|.519
72487352|NCT02807480|144503223|OTHER||Slope|-0.64||||0.326|TWO_SIDED|95.0|-1.92|0.64|||Regression, Linear|||Relationship of striatum activity during points outcomes (reward) with SDS trajectory: time x striatum interaction effects||0.64|-1.92|.326
72487353|NCT02807480|144503223|SUPERIORITY||Slope|1.26||||0.168|TWO_SIDED|95.0|-0.53|3.05|||Regression, Linear|||Relationship of striatum activity during points outcomes (reward) with SDS trajectory: time x treatment x striatum interaction effects||3.05|-0.53|.168
72487354|NCT02807480|144503223|OTHER||Slope|-0.5||||0.248|TWO_SIDED|95.0|-1.34|0.35|||Regression, Linear|||Relationship of right amygdala activity during negative images with SDS trajectory: time x amygdala interaction||0.35|-1.34|.248
72487355|NCT02807480|144503223|SUPERIORITY||Slope|0.3||||0.603|TWO_SIDED|95.0|-0.84|1.44|||Regression, Linear|||Relationship of right amygdala activity during negative images with SDS trajectory: time x treatment amygdala interaction||1.44|-0.84|0.603
72487356|NCT02807480|144503223|OTHER||Slope|-0.85||||0.107|TWO_SIDED|95.0|-1.89|0.18|||Regression, Linear|||Relationship of right dlPFC activity during negative images with SDS trajectory: time x dlPFC interaction||0.18|-1.89|.107
72487357|NCT02807480|144503223|SUPERIORITY||Slope|0.16||||0.846|TWO_SIDED|95.0|-1.47|1.8|||Regression, Linear|||Relationship of right dlPFC activity during negative images with SDS trajectory: time x treatment x dlPFC interaction||1.80|-1.47|0.846
72487358|NCT02807480|144503223|OTHER||Slope|-2.26||||0.561|TWO_SIDED|95.0|-9.89|5.37|||Regression, Linear|||Change in conflict arbitration response time (AAC conflict RT post-pre) predicting trajectories of SDS scores over the 10 sessions: Time x RT\_change interaction||5.37|-9.89|.561
72487359|NCT02807480|144503223|SUPERIORITY||Slope|5.45||||0.297|TWO_SIDED|95.0|-4.8|15.7|||Regression, Linear|||Change in conflict arbitration response time (AAC conflict RT post-pre) predicting trajectories of SDS scores over the 10 sessions: Time x Treatment x RT\_change interaction||15.70|-4.80|.297
72487360|NCT02807480|144503223|OTHER||Slope|-0.18||||0.712|TWO_SIDED|95.0|-1.15|0.79|||Regression, Linear|||Change in behavior (AAC conflict post-pre) predicting trajectories of SDS cores over the 10 sessions: Time x Behavior\_change interaction||0.79|-1.15|.712
72487361|NCT02807480|144503223|SUPERIORITY||Slope|0.56||||0.431|TWO_SIDED|95.0|-0.84|1.97|||Regression, Linear|||Change in behavior (AAC conflict post-pre) predicting trajectories of SDS scores over the 10 sessions: Time x Treatment x Behavior\_change interaction||1.97|-0.84|0.431
72487362|NCT02807480|144503224|OTHER||Slope|-6.42||||0.276|TWO_SIDED|95.0|-18.15|5.3|||Regression, Linear|||Relationships between baseline average approach behavior during conflict trials on the AAC and post-treatment PSWQ score: approach behavior main effect||5.30|-18.15|.276
72487363|NCT02807480|144503224|SUPERIORITY||Slope|5.69||||0.52|TWO_SIDED|95.0|-12.12|23.5|||Regression, Linear|||Relationships between baseline average approach behavior during conflict trials on the AAC and post-treatment PSWQ score: treatment x approach behavior interaction||23.50|-12.12|.520
72487364|NCT02807480|144503224|OTHER||Slope|-50.0||||0.199|TWO_SIDED|95.0|-127.65|27.65|||Regression, Linear|||Relationships between baseline average RT during conflict trials on the AAC and trajectory of PSWQ score: RT main effect||27.65|-127.65|.199
72487365|NCT02807480|144503224|SUPERIORITY||Slope|93.87||||0.191|TWO_SIDED|95.0|-4.14|236.88|||Regression, Linear|||Relationships between baseline average RT during conflict trials on the AAC and trajectory of PSWQ score: treatment x RT interaction||236.88|-4.14|.191
72624146|NCT01892189|144778533|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.13268||0.141|TWO_SIDED|95.0|-0.4696|0.0696|||ANOVA||Difference between least square means of TAK-063 3 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Left Hippocampus: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.0696|-0.4696|0.141
72624147|NCT01892189|144778533|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.0065|STANDARD_ERROR_OF_MEAN|0.14317||0.964|TWO_SIDED|95.0|-0.2975|0.2844|||ANOVA||Difference between least square means of TAK-063 10 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Left Hippocampus: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.2844|-0.2975|0.964
72487366|NCT02807480|144503224|OTHER||Slope|27.35||||0.021|TWO_SIDED|95.0|4.45|50.26|||Regression, Linear|||Relationship of striatum activity during points outcomes (reward) with PSWQ trajectory: striatum main effect||50.26|4.45|0.021
72402997|NCT01358357|144311850|SUPERIORITY_OR_OTHER||LS mean difference lurasidone vs.Placebo|-0.01||||0.42|TWO_SIDED|95.0|-0.5|0.2||Analysis of Covariance (ANCOVA) model contains treatment, and pooled country, and mood stabilizer (lithium or divalproex) as fixed factors and baseline as a covariate.|ANCOVA|||||0.2|-0.5|0.420
72402998|NCT01358357|144311851|SUPERIORITY_OR_OTHER||LS mean difference lurasidone vs.Placebo|-0.2||||0.788|TWO_SIDED|95.0|-1.6|1.2||Analysis of Covariance (ANCOVA) model contains treatment, and pooled country, and mood stabilizer (lithium or divalproex) as fixed factors and baseline as a covariate.|ANCOVA|||||1.2|-1.6|0.788
72487367|NCT02807480|144503224|SUPERIORITY||Slope|-5.47||||0.734|TWO_SIDED|95.0|-37.94|27.0|||Regression, Linear|||Relationship of striatum activity during points outcomes (reward) with PSWQ post-treatment: treatment x striatum interaction effects||27.00|-37.94|.734
72487368|NCT02807480|144503224|OTHER||Slope|-9.79||||0.231|TWO_SIDED|95.0|-26.11|6.53|||Regression, Linear|||Relationship of right amygdala activity during negative images with PSWQ post-treatment: amygdala main effect||6.53|-26.11|.231
72487369|NCT02807480|144503224|SUPERIORITY||Slope|8.55||||0.602|TWO_SIDED|95.0|-24.48|41.58|||Regression, Linear|||Relationship of right amygdala activity during negative images with PSWQ post-treatment: treatment amygdala interaction||41.58|-24.48|.602
72487370|NCT02807480|144503224|OTHER||Slope|-19.29||||0.369|TWO_SIDED|95.0|-62.07|23.68|||Regression, Linear|||Relationship of right dlPFC activity during negative images with PSWQ post-treatment: dlPFC main effect||23.68|-62.07|.369
72514285|NCT03943953|144559201|SUPERIORITY||Mean Difference (Final Values)|3.88||||0.001|TWO_SIDED||||||t-test, 1 sided|||This is a comparison between Time 1 and Time 2||||.001
72514286|NCT03943953|144559203|SUPERIORITY||Mean Difference (Final Values)|3.88||||0.006|TWO_SIDED||||||t-test, 1 sided|||This is a comparison between Time 1 and Time 2||||.006
72514287|NCT03943953|144559205|SUPERIORITY||Mean Difference (Final Values)|-2.28||||0.035|TWO_SIDED||||||t-test, 1 sided|||This is a comparison between Time 1 and Time 2||||.035
72514288|NCT03943953|144559207|SUPERIORITY||Mean Difference (Final Values)|-0.4||||0.39|TWO_SIDED||||||t-test, 1 sided|||This is a comparison between Time 1 and Time 2||||.39
72514289|NCT00753935|144559258|SUPERIORITY|||||||0.005|||||||Wilcoxon rank-sum|||||||0.005
72514290|NCT03970395|144559259|SUPERIORITY||Risk Ratio (RR)|7.66||||0.01|TWO_SIDED|95.0|2.46|23.84||The threshold for statistical significance was p\<0.5|Risk Ratio (RR)||Risk Difference 0.41 (IC 95; 0.25-0.53)|||23.84|2.46|0.01
72514291|NCT03970395|144559260|SUPERIORITY||Risk Ratio (RR)|5.6||||0.01|TWO_SIDED|95.0|2.36|13.27|||Relative Risk (RR)||Risk Difference 0.47 (IC 95; 0.31-0.64)|||13.27|2.36|0.01
72514292|NCT03970395|144559261|SUPERIORITY||Risk Ratio (RR)|7.49||||0.01|TWO_SIDED|95.0|2.42|23.18|||Risk Ratio (RR)||Risk Difference 0.44 (IC 95%; 0.27-0.60)|||23.18|2.42|0.01
72514293|NCT03970395|144559262|SUPERIORITY||Risk Ratio (RR)|4.91||||0.01|TWO_SIDED|95.0|2.12|11.38|||Risk Ratio (RR)||Risk Difference 0.54 (IC 95; 0.36-0.72)|||11.38|2.12|0.01
72487371|NCT02807480|144503224|SUPERIORITY||Slope|9.12||||0.684|TWO_SIDED|95.0|-36.05|54.29|||Regression, Linear|||Relationship of right dlPFC activity during negative images with PSWQ post-treatment: treatment x dlPFC interaction||54.29|-36.05|.684
72514294|NCT03282357|144559291|NON_INFERIORITY|Non-inferiority margin, delta = 10 percent (%). The two-sided 95% confidence interval (CI) for the differences between percentages was constructed using the Newcombe's recommended method.|Difference in Percentage|-6.8|||||TWO_SIDED|95.0|-13.1|-0.5||||||||-0.5|-13.1|
72514295|NCT03282357|144559292|NON_INFERIORITY|Non-inferiority margin, delta = 15%. The two-sided 95% CI for the differences between percentages was constructed using the Newcombe's recommended method.|Difference in Percentage|-4.9|||||TWO_SIDED|95.0|-9.8|-0.3||||||||-0.3|-9.8|
72514296|NCT01586156|144559293|SUPERIORITY|||||||0.04|||||||ANOVA|||||||0.04
72514297|NCT01586156|144559294|SUPERIORITY|||||||0.04|||||||ANOVA|||||||0.04
72514298|NCT01586156|144559295|OTHER|Pearson's correlation test of association of alprenolol binding changes to dose carvedilol.||||||0.02||||||Correlation of the change in alprenolol binding relative to dose carvedilol.|Pearson|||||||0.02
72514299|NCT01586156|144559296|SUPERIORITY|||||||0.05|||||||ANOVA|||||||0.05
72514300|NCT01586156|144559298|OTHER||||||>|0.05|||||||ANOVA|||||||>0.05
72514301|NCT01586156|144559299|NON_INFERIORITY|Carvedilol did not lead to worse cardiac output as compared to placebo.||||||0.8|||||||ANOVA|||||||0.8
72514302|NCT00547378|144559300|SUPERIORITY|||||||0.016|||||||Cochran-Mantel-Haenszel|The two-sided Cochran-Mantel-Haenszel (CMH) test, stratified for center, was used to test the difference in responder rates between the 2 groups||||||0.016
72514303|NCT04105244|144559304|SUPERIORITY||Wald tests|0.05|||<|0.05|TWO_SIDED|95.0|||||Mixed Models Analysis|Intent-to-treat principle using linear mixed-effects models with random intercepts to examine longitudinal change scores for the outcome.||||||<0.05
72514304|NCT04105244|144559305|SUPERIORITY||Wald tests|0.05|||<|0.05|TWO_SIDED|95.0|||||Mixed Models Analysis|Intent-to-treat principle using linear mixed-effects models with random intercepts to examine longitudinal change scores for the outcome.||||||<0.05
72514305|NCT04105244|144559306|SUPERIORITY||Wald test|0.05|||<|0.05|TWO_SIDED|95.0|||||Mixed Models Analysis|Intent-to-treat principle using linear mixed-effects models with random intercepts to examine longitudinal change scores for the outcome.||||||<0.05
72487372|NCT02807480|144503224|OTHER||Slope|9.6||||0.487|TWO_SIDED|95.0|-18.39|37.59|||Regression, Linear|||Change in behavior (AAC conflict post-pre) predicting trajectories of PSWQ cores over the 10 sessions: Behavior\_change main effect||37.59|-18.39|.487
72487373|NCT02807480|144503224|SUPERIORITY||Slope|-46.34||||0.033|TWO_SIDED|95.0|-88.5|-4.18|||Regression, Linear|||Change in behavior (AAC conflict post-pre) predicting trajectories of PSWQ scores over the 10 sessions: Treatment x Behavior\_change interaction||-4.18|-88.5|.033
72487374|NCT02807480|144503224|OTHER||Slope|39.53||||0.546|TWO_SIDED|95.0|-94.2|173.85|||Regression, Linear|||Change in conflict arbitration response time (AAC conflict RT post-pre) predicting trajectories of PSWQ scores over the 10 sessions: RT\_change main effect||173.85|-94.2|.546
72514306|NCT04105244|144559309|SUPERIORITY||Wald test|0.05|||<|0.05|TWO_SIDED|95.0|||||Mixed Models Analysis|Intent-to-treat principle using linear mixed-effects models with random intercepts to examine longitudinal change scores for the outcome.||||||<0.05
72514307|NCT04105244|144559310|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
72402999|NCT01358357|144311852|SUPERIORITY_OR_OTHER||LS mean difference lurasidone vs.Placebo|-0.1||||0.38|TWO_SIDED|95.0|-0.3|0.1||Analysis of Covariance (ANCOVA) model contains treatment, and pooled country, and mood stabilizer (lithium or divalproex) as fixed factors and baseline as a covariate.|ANCOVA|||||0.1|-0.3|0.380
72514308|NCT02768194|144559325|SUPERIORITY||Mean Difference (Net)|-0.11||||0.5512|TWO_SIDED|95.0|-0.46|0.25||From the MMRM model with change from pre-dose as response, participant as a random effect; and treatment, period, day, location of sample in mouth (left or right) and treatment×day interaction as fixed effects; pre-dose mean SEM score as covariate.|Mixed Models Analysis||Difference is the first named treatment minus second named treatment such that a negative difference favours the first named treatment.|||0.25|-0.46|0.5512
72403000|NCT01358357|144311853|SUPERIORITY_OR_OTHER||LS mean difference lurasidone vs.Placebo|0.37||||0.772|TWO_SIDED|95.0|-2.14|2.88||Analysis of Covariance (ANCOVA) model contains treatment, and pooled country, and mood stabilizer (lithium or divalproex) as fixed factors and baseline as a covariate.|ANCOVA|||||2.88|-2.14|0.772
72487375|NCT02807480|144503224|SUPERIORITY||Slope|-89.96||||0.443|TWO_SIDED|95.0|-327.39|147.67|||Regression, Linear|||Change in conflict arbitration response time (AAC conflict RT post-pre) predicting trajectories of PSWQ scores over the 10 sessions: Treatment x RT\_change interaction||147.67|-327.39|.443
72514309|NCT02768194|144559325|SUPERIORITY||Mean Difference (Net)|-0.01||||0.9671|TWO_SIDED|95.0|-0.36|0.35||From the MMRM model with change from pre-dose as response, subject as a random effect; and treatment, period, day, location of sample in mouth (left or right) and treatment×day interaction as fixed effects; pre-dose mean SEM score as covariate.|Mixed Models Analysis||Difference is the first named treatment minus second named treatment such that a negative difference favours the first named treatment.|||0.35|-0.36|0.9671
72514310|NCT02768194|144559325|SUPERIORITY||Mean Difference (Net)|-0.1||||0.583|TWO_SIDED|95.0|-0.46|0.26||From the MMRM model with change from pre-dose as response, subject as a random effect; and treatment, period, day, location of sample in mouth (left or right) and treatment×day interaction as fixed effects; pre-dose mean SEM score as covariate.|Mixed Models Analysis||Difference is the first named treatment minus second named treatment such that a negative difference favours the first named treatment.|||0.26|-0.46|0.5830
72514311|NCT00975195|144559327|NON_INFERIORITY_OR_EQUIVALENCE|Upper limit of 95% confidence interval (CI) \<1.2 indicates non-inferiority of Fluticasone withdrawal compared with Fluticasone maintenance|Hazard Ratio (HR)|1.058||||0.3497|TWO_SIDED|95.0|0.941|1.189||Two-sided p-value to test superiority of fluticasone maintenance over fluticasone withdrawal if non-inferiority shown.|Chi-squared|Wald's chi-square test|Ratio calculated as fluticasone withdrawal divided by fluticasone maintenance|||1.189|0.941|0.3497
72514312|NCT00975195|144559328|SUPERIORITY_OR_OTHER||Rate ratio|1.05|STANDARD_ERROR_OF_MEAN|0.06||0.4441|TWO_SIDED|95.0|0.93|1.18|||Regression, Negative Binomial|Adjusted for log time at risk using log link function|Ratio calculated as fluticasone withdrawal divided by fluticasone maintenance|||1.18|0.93|0.4441
72487376|NCT02807480|144503225|OTHER||Slope|-1.01||||0.357|TWO_SIDED|95.0|-3.22|1.19|||Regression, Linear|||Relationships between baseline average approach behavior during conflict trials on the AAC and post-treatment BDI-II score: approach behavior main effect||1.19|-3.22|.357
72487377|NCT02807480|144503225|SUPERIORITY||Slope|0.37||||0.812|TWO_SIDED|95.0|-2.74|3.47|||Regression, Linear|||Relationships between baseline average approach behavior during conflict trials on the AAC and post-treatment BDI-II score: treatment x approach behavior interaction||3.47|-2.74|.812
72487378|NCT02807480|144503225|OTHER||Slope|2.01||||0.826|TWO_SIDED|95.0|-16.42|20.45|||Regression, Linear|||Relationships between baseline average RT during conflict trials on the AAC and post-treatment BDI-II score: RT main effect||20.45|-16.42|.826
72487379|NCT02807480|144503225|SUPERIORITY||Slope|-2.89||||0.838|TWO_SIDED|95.0|-31.42|25.64|||Regression, Linear|||Relationships between baseline average RT during conflict trials on the AAC and post-treatment BDI-II score: treatment x RT interaction||25.64|-31.42|.838
72514313|NCT00975195|144559329|SUPERIORITY_OR_OTHER|||||||0.2269|TWO_SIDED||||||Fisher Exact|||||||0.2269
72514314|NCT00975195|144559330|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.202||||0.0849|TWO_SIDED|95.0|0.975|1.481|||Chi-squared|Wald's chi-square test|Ratio calculated as fluticasone withdrawal divided by fluticasone maintenance|||1.481|0.975|0.0849
72514315|NCT00975195|144559331|SUPERIORITY_OR_OTHER||Rate ratio|1.15|STANDARD_ERROR_OF_MEAN|0.13||0.2291|TWO_SIDED|95.0|0.92|1.45|||Regression, Negative Binomial|Adjusted for log time at risk using log link function|Ratio calculated as fluticasone withdrawal divided by fluticasone maintenance|||1.45|0.92|0.2291
72514316|NCT00975195|144559332|SUPERIORITY_OR_OTHER|||||||0.2083|TWO_SIDED||||||Fisher Exact|||||||0.2083
72403001|NCT02136576|144311854|SUPERIORITY|||||||0.72||||||"This p-value is for the Air Schiff comparison.~The threshold of significance was 0.05 and no multiple comparisons were necessary."|Kruskal-Wallis|||Assuming the control group may exhibit a modest improvement in dentinal hypersensitivity (\~5%) whereas the two test groups should demonstrate a more significant improvement (\~30%). Assuming a common standard deviation of 25%, we will have 58% power to detect a difference between the 3 groups using one way analysis of variance, with 10 subjects per group, and setting alpha to 0.05 (nQuery Advisor, Version 7.0). Up to 13 subjects per group will be recruited, to allow for a 20% dropout rate.||||0.72
72403002|NCT02136576|144311854|SUPERIORITY|||||||0.93||||||"This p-value is for the Air VAS comparison.~The threshold of significance was 0.05 and no multiple comparisons were necessary."|Kruskal-Wallis|||Assuming the control group may exhibit a modest improvement in dentinal hypersensitivity (\~5%) whereas the two test groups should demonstrate a more significant improvement (\~30%). Assuming a common standard deviation of 25%, we will have 58% power to detect a difference between the 3 groups using one way analysis of variance, with 10 subjects per group, and setting alpha to 0.05 (nQuery Advisor, Version 7.0). Up to 13 subjects per group will be recruited, to allow for a 20% dropout rate.||||.93
72403003|NCT02136576|144311854|SUPERIORITY|||||||0.77||||||"This p-value is for the WaterSchiff comparison.~The threshold of significance was 0.05 and no multiple comparisons were necessary."|Kruskal-Wallis|||Assuming the control group may exhibit a modest improvement in dentinal hypersensitivity (\~5%) whereas the two test groups should demonstrate a more significant improvement (\~30%). Assuming a common standard deviation of 25%, we will have 58% power to detect a difference between the 3 groups using one way analysis of variance, with 10 subjects per group, and setting alpha to 0.05 (nQuery Advisor, Version 7.0). Up to 13 subjects per group will be recruited, to allow for a 20% dropout rate.||||.77
72403004|NCT02136576|144311854|SUPERIORITY|||||||0.93||||||"This p-value is for the WaterVAS comparison.~The threshold of significance was 0.05 and no multiple comparisons were necessary."|Kruskal-Wallis|||Assuming the control group may exhibit a modest improvement in dentinal hypersensitivity (\~5%) whereas the two test groups should demonstrate a more significant improvement (\~30%). Assuming a common standard deviation of 25%, we will have 58% power to detect a difference between the 3 groups using one way analysis of variance, with 10 subjects per group, and setting alpha to 0.05 (nQuery Advisor, Version 7.0). Up to 13 subjects per group will be recruited, to allow for a 20% dropout rate.||||.93
72403005|NCT00537381|144311855|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.728||||0.014|TWO_SIDED|95.0|1.112|2.686|||Log Rank||Hazard ratio and 95% confidence interval was estimated from a Cox proportional hazards model with treatment as the only explanatory factor.|||2.686|1.112|0.014
72403006|NCT00537381|144311856|SUPERIORITY_OR_OTHER|||||||0.795|||||||Fisher Exact|||||||0.795
72514317|NCT00975195|144559333|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.035||||0.5562|TWO_SIDED|95.0|0.923|1.16|||Chi-squared|||||1.160|0.923|0.5562
72403007|NCT00537381|144311857|SUPERIORITY_OR_OTHER|||||||0.018|||||||Fisher Exact|||||||0.018
72514318|NCT00975195|144559334|SUPERIORITY_OR_OTHER||Rate ratio|1.05|STANDARD_ERROR_OF_MEAN|0.06||0.4342|TWO_SIDED|95.0|0.93|1.18|||Regression, Negative binomial|Adjusted for log time at risk using log link function|Ratio calculated as fluticasone withdrawal divided by fluticasone maintenance|||1.18|0.93|0.4342
72514319|NCT00975195|144559335|SUPERIORITY_OR_OTHER|||||||0.3155|TWO_SIDED||||||Fisher Exact|||||||0.3155
72403008|NCT00537381|144311858|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.476||||0.163|TWO_SIDED|95.0|0.853|2.522|||Log Rank||Hazard ratio and 95% confidence interval was estimated from a Cox proportional hazards model with treatment as the only explanatory factor.|||2.522|0.853|0.163
72403009|NCT02590939|144311862|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
72403010|NCT02590939|144311863|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
72403011|NCT02590939|144311864|SUPERIORITY|||||||0.666||||||Statistical significance threshold set to 0.05|Fisher Exact|||||||0.666
72403012|NCT02590939|144311865|SUPERIORITY|||||||0.026||||||Statistical significance threshold set to 0.05|Wilcoxon (Mann-Whitney)|||||||0.026
72403013|NCT02590939|144311866|SUPERIORITY|||||||1||||||Statistical significance threshold set to 0.05|Wilcoxon (Mann-Whitney)|||||||1
72403014|NCT02590939|144311867|SUPERIORITY|||||||0.037||||||Statistical significance threshold set to 0.05|Wilcoxon (Mann-Whitney)|||||||0.037
72403015|NCT02590939|144311868|SUPERIORITY|||||||0.028||||||Statistical significance threshold set to 0.05|Wilcoxon (Mann-Whitney)|||||||0.028
72403016|NCT02590939|144311869|SUPERIORITY|||||||0.062||||||Statistical significance threshold set to 0.05|Wilcoxon (Mann-Whitney)|||||||0.062
72403017|NCT00108160|144311874|SUPERIORITY_OR_OTHER|||||||0.356||||||No adjustments were made for multiple comparisons.|Chi-squared|||Our null hypothesis was that no significant effect of mupirocin ointment (treatment) on S. aureus re-infection would be seen at 18 months compared with placebo ointment. Based on prior studies, we estimated that 198 participants would need to be enrolled assuming a 20% dropout rate; 84 participants per arm would be required to detect a 66% decrease in re-infection from 30% to 10% with a significance level alpha of 0.05 and a power of 0.9.||||0.356
72403018|NCT01331148|144311905|OTHER|||||||0.0507|||||||t-test, 2 sided|||Due to the longitudinal nature of the data and presence of missing values, repeated measures analyses were conducted using the MIXED procedure in SAS. Spearman's rank correlation coefficient was used to quantify the relationship between PedsQL scores with 25OHD concentrations and pain days. Two-way analysis of variance models compared PedsQL scores between treatment groups over time.||||0.0507
72403019|NCT04709575|144311906|SUPERIORITY||linear mixed-effect model|-0.995||||0.0497|TWO_SIDED|95.0|-1.9886|-0.0011|||LS Mean Difference|||||-0.0011|-1.9886|0.0497
72403020|NCT05477875|144311940|EQUIVALENCE|Two-way ANOVA using group and intervention as fixed factors were analyzed, with outcome variable p-value reported below, threshold 0.05.||||||0.538|||||||Wilcoxon (Mann-Whitney)|||||||0.538
72514320|NCT00975195|144559337|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.043|STANDARD_ERROR_OF_MEAN|0.0134||0.0014|TWO_SIDED|95.0|-0.069|-0.017|||Restricted maximum likelihood|Repeated measures restricted maximum likelihood|Difference calculated as fluticasone withdrawal minus fluticasone maintenance|Week 52 visit||-0.017|-0.069|0.0014
72514321|NCT00975195|144559338|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.064|STANDARD_ERROR_OF_MEAN|0.034||0.0632|TWO_SIDED|95.0|-0.004|0.131|||Restricted maximum likelihood|Repeated measures restricted maximum likelihood|Difference calculated as fluticasone withdrawal minus fluticasone maintenance|Week 52 visit||0.131|-0.004|0.0632
72487380|NCT02807480|144503225|OTHER||Slope|-0.68||||0.776|TWO_SIDED|95.0|-5.51|4.14|||Regression, Linear|||Relationship of striatum activity during points outcomes (reward) with BDI-II post-treatment: striatum main effect||4.14|-5.51|.776
72487381|NCT02807480|144503225|SUPERIORITY||Slope|-0.69||||0.844|TWO_SIDED|95.0|-7.79|6.4|||Regression, Linear|||Relationship of striatum activity during points outcomes (reward) with BDI-II post-treatment: treatment x striatum interaction effects||6.40|-7.79|.844
72487382|NCT02807480|144503225|OTHER||Slope|0.88||||0.719|TWO_SIDED|95.0|-4.03|5.79|||Regression, Linear|||Relationship of right amygdala activity during negative images with BDI-II post-treatment: amygdala main effect||5.79|-4.03|.719
72487383|NCT02807480|144503225|SUPERIORITY||Slope|-2.33||||0.464|TWO_SIDED|95.0|-8.74|4.07|||Regression, Linear|||Relationship of right amygdala activity during negative images with BDI-II post-treatment: treatment x amygdala interaction||4.07|-8.74|.464
72487384|NCT02807480|144503225|OTHER||Slope|5.91||||0.135|TWO_SIDED|95.0|-1.93|13.75|||Regression, Linear|||Relationship of right dlPFC activity during negative images with BDI-II post-treatment: dlPFC main effect||13.75|-1.93|.135
72487385|NCT02807480|144503225|SUPERIORITY||Slope|-6.09||||0.158|TWO_SIDED|95.0|-14.65|2.47|||Regression, Linear|||Relationship of right dlPFC activity during negative images with BDI-II post-treatment: treatment x dlPFC interaction||2.47|-14.65|.158
72487386|NCT02807480|144503225|OTHER||Slope|1.16||||0.69|TWO_SIDED|95.0|-4.78|7.11|||Regression, Linear|||Change in behavior (AAC conflict post-pre) predicting trajectories of BDI-II cores over the 10 sessions: Behavior\_change main effect||7.11|-4.78|.690
72487387|NCT02807480|144503225|SUPERIORITY||Slope|-1.37||||0.715|TWO_SIDED|95.0|-8.99|6.25|||Regression, Linear|||Change in behavior (AAC conflict post-pre) predicting trajectories of BDI-II scores over the 10 sessions: Treatment x Behavior\_change interaction||6.25|-8.99|.715
72487388|NCT02807480|144503225|OTHER||Slope|5.14||||0.74|TWO_SIDED|95.0|-26.38|36.65|||Regression, Linear|||Change in conflict arbitration response time (AAC conflict RT post-pre) predicting trajectories of BDI-II scores over the 10 sessions: RT\_change main effect||36.65|-26.38|.740
72514322|NCT00975195|144559339|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.013|STANDARD_ERROR_OF_MEAN|0.055||0.8137|TWO_SIDED|95.0|-0.122|0.096|||Restricted maximum likelihood|Repeated measures restricted maximum likelihood|Difference calculated as fluticasone withdrawal minus fluticasone maintenance|Week 52 visit||0.096|-0.122|0.8137
72514323|NCT00975195|144559340|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.53|STANDARD_ERROR_OF_MEAN|3.17||0.2663|TWO_SIDED|95.0|-9.74|2.69|||Restricted maximum likelihood|Repeated measures restricted maximum likelihood|Difference calculated as fluticasone withdrawal minus fluticasone maintenance|Week 52 visit||2.69|-9.74|0.2663
72514324|NCT00975195|144559341|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.16|STANDARD_ERROR_OF_MEAN|0.06||0.0033|TWO_SIDED|95.0|0.05|0.27|||Restricted maximum likelihood|Repeated measures restricted maximum likelihood|Difference calculated as fluticasone withdrawal minus fluticasone maintenance|Week 52 visit||0.27|0.05|0.0033
72514325|NCT00975195|144559342|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.03|STANDARD_ERROR_OF_MEAN|1.499||0.4914|TWO_SIDED|95.0|-3.98|1.91|||Restricted maximum likelihood|Repeated measures restricted maximum likelihood|Difference calculated as fluticasone withdrawal minus fluticasone maintenance|Week 52 visit||1.91|-3.98|0.4914
72514326|NCT00975195|144559343|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.56|STANDARD_ERROR_OF_MEAN|1.669||0.349|TWO_SIDED|95.0|-4.84|1.71|||Restricted maximum likelihood|Repeated measures restricted maximum likelihood|Difference calculated as fluticasone withdrawal minus fluticasone maintenance|Week 52 visit||1.71|-4.84|0.3490
72403021|NCT05477875|144311941|EQUIVALENCE|Two-way ANOVA using group and intervention as fixed factors were analyzed, with outcome variable p-value reported below, threshold 0.05.||||||0.538|||||||ANOVA|||||||0.538
72487389|NCT02807480|144503225|SUPERIORITY||Slope|-0.98||||0.966|TWO_SIDED|95.0|-48.1|46.14|||Regression, Linear|||Change in conflict arbitration response time (AAC conflict RT post-pre) predicting trajectories of BDI-II scores over the 10 sessions: Treatment x RT\_change interaction||46.14|-48.10|.966
72487390|NCT01901575|144503292|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.65|STANDARD_ERROR_OF_MEAN|0.75||0.05|TWO_SIDED|0.15|0.65|0.8|||Fisher Exact|||"null hypothesis:~Remifentanil IVPCA sedation in patients undergoing ablation of the idiopathic ventricular tachycardia does not cause suppression of PVC's"||0.8|0.65|0.05
72487391|NCT05714982|144503300|SUPERIORITY||||||<|0.001|||||||General linear model|||||||<.001
72487392|NCT05714982|144503300|SUPERIORITY|||||||0.78|||||||General linear model|||||||.78
72487393|NCT05714982|144503301|SUPERIORITY||||||<|0.001|||||||General linear model|||||||<.001
72487394|NCT05714982|144503301|SUPERIORITY|||||||0.66|||||||General linear model|||||||.66
72487395|NCT05714982|144503302|SUPERIORITY||||||<|0.001|||||||General linear model|||||||<.001
72487396|NCT05714982|144503302|SUPERIORITY||||||<|0.001|||||||General linear model|||||||<.001
72487397|NCT05714982|144503303|SUPERIORITY|||||||0.001|||||||General linear model|||||||.001
72487398|NCT05714982|144503303|SUPERIORITY|||||||0.95|||||||General linear model|||||||.95
72487399|NCT05714982|144503304|SUPERIORITY||||||<|0.001|||||||General linear model|||||||<.001
72487400|NCT05714982|144503304|SUPERIORITY||||||<|0.001|||||||General linear model|||||||<.001
72487401|NCT05714982|144503305|SUPERIORITY||||||<|0.0001|||||||General linear model|||||||<.0001
72487402|NCT05714982|144503305|SUPERIORITY||||||<|0.001|||||||General linear model|||||||<.001
72487403|NCT05714982|144503306|SUPERIORITY||||||<|0.001|||||||General linear model|||||||<.001
72487404|NCT05714982|144503306|SUPERIORITY|||||||0.4|||||||General linear model|||||||.4
72487405|NCT05714982|144503307|SUPERIORITY|||||||0.03|||||||General linear model|||||||.03
72487406|NCT05714982|144503307|SUPERIORITY|||||||0.4|||||||General linear model|||||||.4
72487407|NCT05714982|144503308|SUPERIORITY|||||||0.61|||||||General linear model|||||||.61
72514327|NCT00975195|144559344|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.14|STANDARD_ERROR_OF_MEAN|1.48||0.9262|TWO_SIDED|95.0|-2.77|3.04|||Restricted maximum likelihood|Repeated measures restricted maximum likelihood|Difference calculated as fluticasone withdrawal minus fluticasone maintenance|Week 52 visit||3.04|-2.77|0.9262
72514328|NCT00975195|144559345|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.64|STANDARD_ERROR_OF_MEAN|1.716||0.1241|TWO_SIDED|95.0|-0.73|6.01|||Restricted maximum likelihood|Repeated measures restricted maximum likelihood|Difference calculated as fluticasone withdrawal minus fluticasone maintenance|Week 52 visit||6.01|-0.73|0.1241
72487408|NCT05714982|144503308|SUPERIORITY|||||||0.68|||||||General linear model|||||||.68
72487409|NCT05714982|144503309|SUPERIORITY|||||||0.4|||||||General linear model|||||||.4
72487410|NCT05714982|144503309|SUPERIORITY|||||||0.5|||||||General linear model|||||||.5
72487411|NCT05714982|144503310|SUPERIORITY|||||||0.001|||||||General linear model|||||||.001
72487412|NCT05714982|144503310|SUPERIORITY|||||||0.9|||||||General linear model|||||||.9
72514329|NCT00975195|144559346|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.048|STANDARD_ERROR_OF_MEAN|0.0123|<|0.0001|TWO_SIDED|95.0|-0.073|-0.024|||Restricted maximum likelihood|Repeated measures restricted maximum likelihood|Difference calculated as fluticasone withdrawal minus fluticasone maintenance|Week 52 visit||-0.024|-0.073|<0.0001
72514330|NCT00975195|144559347|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.044|STANDARD_ERROR_OF_MEAN|0.0255||0.0855|TWO_SIDED|95.0|-0.094|0.006|||Restricted maximum likelihood|Repeated measures restricted maximum likelihood|Difference calculated as fluticasone withdrawal minus fluticasone maintenance|Week 52 visit||0.006|-0.094|0.0855
72514331|NCT00975195|144559348|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.161|STANDARD_ERROR_OF_MEAN|0.045||0.0004|TWO_SIDED|95.0|-0.249|-0.073|||Restricted maximum likelihood|Repeated measures restricted maximum likelihood|Difference calculated as fluticasone withdrawal minus fluticasone maintenance|Week 52 visit||-0.073|-0.249|0.0004
72487413|NCT05714982|144503311|SUPERIORITY||Odds Ratio (OR)|0.9|||||TWO_SIDED|95.0|0.73|1.2||||||||1.2|.73|
72514332|NCT00975195|144559349|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.97|STANDARD_ERROR_OF_MEAN|0.728||0.1838|TWO_SIDED|95.0|-0.46|2.4|||Restricted maximum likelihood|Repeated measures restricted maximum likelihood|Difference calculated as fluticasone withdrawal minus fluticasone maintenance|Week 52 visit||2.40|-0.46|0.1838
72403022|NCT05477875|144311942|EQUIVALENCE|Two-way ANOVA using group and intervention as fixed factors were analyzed, with outcome variable p-value reported below, threshold 0.05.||||||0.516|||||||ANOVA|||||||0.516
72403023|NCT05477875|144311943|EQUIVALENCE|"Alpha = 0.05, two-way ANOVA with Group x Time Points as fixed factors and PROWL-SS from (1-100) as the dependent variable."|||||<|0.851|||||||ANOVA|||||||<0.851
72514333|NCT00975195|144559350|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.35|STANDARD_ERROR_OF_MEAN|0.702||0.0551|TWO_SIDED|95.0|-0.03|2.72|||Restricted maximum likelihood|Repeated measures restricted maximum likelihood|Difference calculated as fluticasone withdrawal minus fluticasone maintenance|Week 52 visit||2.72|-0.03|0.0551
72514334|NCT00975195|144559351|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.6|STANDARD_ERROR_OF_MEAN|0.845||0.4804|TWO_SIDED|95.0|-1.06|2.25|||Restricted maximum likelihood|Repeated measures restricted maximum likelihood|Difference calculated as fluticasone withdrawal minus fluticasone maintenance|Week 52 visit||2.25|-1.06|0.4804
72514335|NCT00975195|144559352|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.22|STANDARD_ERROR_OF_MEAN|0.614||0.0467|TWO_SIDED|95.0|0.02|2.43|||Restricted maximum likelihood|Repeated measures restricted maximum likelihood|Difference calculated as fluticasone withdrawal minus fluticasone maintenance|Week 52 visit||2.43|0.02|0.0467
72514336|NCT00975195|144559353|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.11|STANDARD_ERROR_OF_MEAN|0.05||0.0223|TWO_SIDED|95.0|-0.21|-0.02|||Restricted maximum likelihood|Repeated measures restricted maximum likelihood|Difference calculated as fluticasone withdrawal minus fluticasone maintenance|Week 52 visit||-0.02|-0.21|0.0223
72514337|NCT00363246|144559366|SUPERIORITY_OR_OTHER|||||||0.049|TWO_SIDED||||||Chi-squared|||Health Status. No Wheelchair-related Fall Injuries vs. Wheelchair-related Fall Injuries.||||0.049
72514338|NCT00363246|144559366|SUPERIORITY_OR_OTHER|||||||0.013|TWO_SIDED||||||Chi-squared|||Pain in last 4 weeks (interference with daily activities). No Wheelchair-related Fall Injuries vs. Wheelchair-related Fall Injuries.||||0.013
72403024|NCT05477875|144311944|EQUIVALENCE|"Alpha = 0.05, two-way ANOVA with Group x Time Points as fixed factors and QIRC from (1-100) as the dependent variable."|||||<|0.543|||||||ANOVA|||||||<0.543
72403025|NCT05477875|144311945|EQUIVALENCE|"Alpha = 0.05, two-way ANOVA with Group x Time Points as fixed factors and OSDI from (0-48) as the dependent variable."||||||0.725|||||||ANOVA|||||||0.725
72403026|NCT05477875|144311946|EQUIVALENCE|Two-way ANOVA using group and intervention as fixed factors were analyzed, with outcome variable p-value reported below, threshold 0.05.||||||0.516|||||||ANOVA|||||||0.516
72403027|NCT04254978|144311961|SUPERIORITY||||||<|0.0001|||||||Exact binomial distribution|||Comparison of the true response rate of bomedemstat to a fixed efficacy target of 5%: Null hypothesis (H0): p ≤ 0.05 versus alternate hypothesis (H1): p \> 0.05||||<.0001
72487414|NCT05714982|144503311|SUPERIORITY||Odds Ratio (OR)|0.9|||||TWO_SIDED|95.0|0.69|1.2||||||||1.2|.69|
72487415|NCT05714982|144503312|SUPERIORITY||Odds Ratio (OR)|0.5|||||TWO_SIDED|95.0|0.3|0.9||||||||.9|.3|
72487416|NCT05714982|144503312|SUPERIORITY||Odds Ratio (OR)|1.0|||||TWO_SIDED|95.0|0.6|1.7||||||||1.7|.6|
72487417|NCT05714982|144503313|SUPERIORITY|||||||0.02|||||||General linear model|||||||.02
72487418|NCT05714982|144503313|SUPERIORITY|||||||0.5|||||||General linear model|||||||.5
72487419|NCT05714982|144503314|SUPERIORITY||||||<|0.001|||||||General linear model|||||||<.001
72487420|NCT05714982|144503314|SUPERIORITY|||||||0.004|||||||General linear model|||||||.004
72487421|NCT05714982|144503315|SUPERIORITY|||||||0.3|||||||General linear model|||||||0.3
72487422|NCT05714982|144503315|SUPERIORITY|||||||0.5|||||||General linear model|||||||0.5
72487423|NCT05714982|144503316|SUPERIORITY||Odds Ratio (OR)|1.4|||||TWO_SIDED|95.0|0.99|2.1||||||||2.1|.99|
72487424|NCT05714982|144503316|SUPERIORITY||Odds Ratio (OR)|1.8|||||TWO_SIDED|95.0|1.2|2.6||||||||2.6|1.2|
72487425|NCT00549939|144503317|SUPERIORITY_OR_OTHER|||||||1||||||P-value was adjusted for multiplicity using the Hochberg procedure. The a priori threshold for statistical significance was 0.05.|Fisher Exact|||||||1.00
72487426|NCT00549939|144503317|SUPERIORITY_OR_OTHER|||||||0.91||||||P-value was adjusted for multiplicity using the Hochberg procedure. The a priori threshold for statistical significance was 0.05.|Fisher Exact|||||||0.91
72487427|NCT00549939|144503319|SUPERIORITY_OR_OTHER||LS Mean difference versus Placebo|-6.2|STANDARD_ERROR_OF_MEAN|3.8||0.104|TWO_SIDED|95.0|-13.72|1.29||P-value was adjusted for multiplicity using the Hochberg procedure. The a priori threshold for statistical significance was 0.05.|ANCOVA|||"Change in detrusor LPP was analyzed using a three-way analysis of covariance (ANCOVA) including 3 variables as fixed effects:~* treatment group (alfuzosin 0.1 mg/kg/day, alfuzosin 0.2 mg/kg/day or placebo),~* age/formulation group (2-7 years of age on solution, 8-16 years of age on solution or 8-16 years of age on tablets),~* anticholinergic/antimuscarinic use (yes or no),~and using centered baseline detrusor LPP as covariate."||1.29|-13.72|0.1040
72403028|NCT00277212|144311962|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.552||||0.058|TWO_SIDED|95.0|0.296|1.03||stratified Log-Rank test, controlling for type of index mood episode|Log Rank||Cox's proportional hazards model, with type of index modd episode as stratification factor, and randomized treatment group as covariate.|||1.030|0.296|0.058
72514339|NCT00363246|144559366|SUPERIORITY_OR_OTHER|||||||0.0001|TWO_SIDED||||||Chi-squared|||Pain when transfer. No Wheelchair-related Fall Injuries vs. Wheelchair-related Fall Injuries.||||0.0001
72403029|NCT00277212|144311963|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.671||||0.055|TWO_SIDED|95.0|0.446|1.011||p-value for equality of survival curves|Log Rank|stratified log-rank test, controlling for type of index mood episode|aripiprazole/placebo; Cox's proportional hazards model, with type of index mood episode as stratification facto, and randomized treatment group as covariate.|||1.011|0.446|0.055
72403030|NCT00277212|144311964|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.784||||0.381|TWO_SIDED|95.0|0.454|1.354||p-value for equality of survival curves|Log Rank|stratified log-rank test, conrolling for type of index mood episode|aripiprazole/placebo; Cox's proportional hazards model, with type of index mood episode as stratification facto, and randomized treatment group as covariate.|||1.354|0.454|0.381
72403031|NCT00277212|144311965|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.871||||0.295|TWO_SIDED|95.0|0.672|1.128||p-value for equality of survival curves|Log Rank|stratified Log-Rank Test, controlling for type of index mood episode|aripiprazole/placebo; Cox's proportional hazards model, with type of index mood episode as stratification facto, and randomized treatment group as covariate.|||1.128|0.672|0.295
72403032|NCT00277212|144311967|SUPERIORITY_OR_OTHER||Treatement Difference|2.24||||0.001|TWO_SIDED|95.0|0.91|3.57||ANOVA (main effects=double-blind treatment, covariate=index mood episode) used for baseline comparisons. ANCOVA (main effects=double-blind treatment, covariates=index mood episode \& baseline assessment) used for mean change from baseline comparisons|ANCOVA||Aripiprazole vs. placebo|Week 52 LOCF||3.57|0.91|0.001
72403033|NCT00277212|144311968|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.56||||0.073|TWO_SIDED|95.0|0.29|1.07|||Cochran-Mantel-Haenszel||aripiprazole/placebo|Week 52 LOCF||1.07|0.29|0.073
72403034|NCT00277212|144311968|SUPERIORITY_OR_OTHER|||||||0.194||95.0|||||Cochran-Mantel-Haenszel|||At Any Time||||0.194
72403035|NCT00277212|144311969|SUPERIORITY_OR_OTHER||relative risk|3.41||||0.007|TWO_SIDED|95.0|1.3|8.94|||Cochran-Mantel-Haenszel|||Week 52 LOCF||8.94|1.30|0.007
72403036|NCT00277212|144311969|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||Cochran-Mantel-Haenszel|||||||0.001
72403037|NCT00277212|144311970|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.64||||0.467|TWO_SIDED|95.0|-2.37|1.09||Means, treatment differences between aripiprazole and placebo, 95% confidence intervals for the differences and the p-values for treatment comparisons are based on ANOVA/ANCOVA model.|ANCOVA|ANCOVA model, with double-blind treatment as main effects and index mood episode as covariate, is used for Baseline comparisons.|aripiprazole - placebo|Baseline||1.09|-2.37|0.467
72403038|NCT00277212|144311970|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.36|||||TWO_SIDED|95.0|-0.06|0.78||Means, treatment differences between aripiprazole and placebo, 95% confidence intervals for the differences and the p-values for treatment comparisons are based on ANOVA/ANCOVA model.|ANCOVA|ANCOVA (main effects=double-blind treatment, covariates=index mood episode \& baseline assessment) used for mean change from baseline comparisons.|aripiprazole - placebo|Change from Baseline at Week 12||0.78|-0.06|
72403039|NCT00277212|144311970|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.75|||||TWO_SIDED|95.0|0.19|1.3||Means, treatment differences between aripiprazole and placebo, 95% confidence intervals for the differences and the p-values for treatment comparisons are based on ANOVA/ANCOVA model.|ANCOVA|ANCOVA (main effects=double-blind treatment, covariates=index mood episode \& baseline assessment) used for mean change from baseline comparisons.|aripiprazole - placebo|Change from baseline at Week 24||1.30|0.19|
72403040|NCT00277212|144311970|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.97|||||TWO_SIDED|95.0|0.08|1.86||Means, treatment differences between aripiprazole and placebo, 95% confidence intervals for the differences and the p-values for treatment comparisons are based on ANOVA/ANCOVA model.|ANCOVA|ANCOVA (main effects=double-blind treatment, covariates=index mood episode \& baseline assessment) used for mean change from baseline comparisons.|aripiprazole - placebo|Change from baseline at Week 36||1.86|0.08|
72403041|NCT00277212|144311970|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.92|||||TWO_SIDED|95.0|-0.08|1.92||Means, treatment differences between aripiprazole and placebo, 95% confidence intervals for the differences and the p-values for treatment comparisons are based on ANOVA/ANCOVA model.|ANCOVA|ANCOVA (main effects=double-blind treatment, covariates=index mood episode \& baseline assessment) used for mean change from baseline comparisons.|aripiprazole - placebo|Change from baseline at Week 52||1.92|-0.08|
72403042|NCT00277212|144311970|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.79||||0.001|TWO_SIDED|95.0|0.31|1.26||Means, treatment differences between aripiprazole and placebo, 95% confidence intervals for the differences and the p-values for treatment comparisons are based on ANOVA/ANCOVA model.|ANCOVA|ANCOVA (main effects=double-blind treatment, covariates=index mood episode \& baseline assessment) used for mean change from baseline comparisons.|aripiprazole - placebo|Change from baseline at Week 52 (LOCF)||1.26|0.31|0.001
72403043|NCT00277212|144311970|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.63||||0.002|TWO_SIDED|95.0|0.23|1.04||Means, treatment differences between aripiprazole and placebo, 95% confidence intervals for the differences and the p-values for treatment comparisons are based on ANOVA/ANCOVA model.|ANCOVA|ANCOVA (main effects=double-blind treatment, covariates=index mood episode \& baseline assessment) used for mean change from baseline comparisons.|aripiprazole - placebo|Highest Change from baseline||1.04|0.23|0.002
72403044|NCT00277212|144311976|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01||||0.971|TWO_SIDED|95.0|-0.35|0.34||Means, treatment differences between aripiprazole and placebo, 95% confidence intervals for the differences and the p-values for treatment comparisons are based on ANOVA/ANCOVA model.|ANOVA|ANOVA model, with double-blind treatment as main effects, is used for Baseline comparisons.|aripiprazole - placebo|Baseline||0.34|-0.35|0.971
72514340|NCT00363246|144559366|SUPERIORITY_OR_OTHER|||||||0.009|TWO_SIDED||||||t-test, 2 sided|||Energy level. No Wheelchair-related Fall Injuries vs. Wheelchair-related Fall Injuries.||||0.009
72514341|NCT00363246|144559367|SUPERIORITY_OR_OTHER|||||||0.033|TWO_SIDED||||||Chi-squared|We used chi-squared test for categorical variable (most variables) and t-test (2-sided) for continuous variables (few variables).||Health Status. No Wheelchair-related Falls vs. Wheelchair-related Falls.||||0.033
72487428|NCT00549939|144503319|SUPERIORITY_OR_OTHER||LS Mean difference versus Placebo|-7.1|STANDARD_ERROR_OF_MEAN|3.77||0.104|TWO_SIDED|95.0|-14.51|0.39||P-value was adjusted for multiplicity using the Hochberg procedure. The a priori threshold for statistical significance was 0.05.|ANCOVA|||||0.39|-14.51|0.1040
72487429|NCT00549939|144503320|SUPERIORITY_OR_OTHER||LS Mean difference versus Placebo|-11.4|STANDARD_ERROR_OF_MEAN|7.54||0.1338|TWO_SIDED|95.0|-26.27|3.53||P-values was adjusted for multiplicity using the Hochberg procedure. The a priori threshold for statistical significance was 0.05.|ANCOVA|||"Change in detrusor LPP was analyzed using a three-way analysis of covariance (ANCOVA) including 3 variables as fixed effects:~* treatment group (alfuzosin 0.1 mg/kg/day, alfuzosin 0.2 mg/kg/day or placebo),~* age/formulation group (2-7 years of age on solution, 8-16 years of age on solution or 8-16 years of age on tablets),~* anticholinergic/antimuscarinic use (yes or no),~and using centered baseline detrusor LPP as covariate."||3.53|-26.27|0.1338
72487430|NCT00549939|144503320|SUPERIORITY_OR_OTHER||LS Mean difference versus Placebo|-14.3|STANDARD_ERROR_OF_MEAN|7.48||0.1152|TWO_SIDED|95.0|-29.1|0.47||P-value was adjusted for multiplicity using the Hochberg procedure. The a priori threshold for statistical significance was 0.05.|ANCOVA|||||0.47|-29.10|0.1152
72487431|NCT00549939|144503322|SUPERIORITY_OR_OTHER|||||||0.7889||||||P-value was adjusted for multiplicity using the Hochberg procedure. The a priori threshold for statistical significance was 0.05.|ANCOVA|||"Change in detrusor compliance was analyzed using a three-way analysis of covariance (ANCOVA) including 3 variables as fixed effects:~* treatment group (alfuzosin 0.1 mg/kg/day, alfuzosin 0.2 mg/kg/day or placebo),~* age/formulation group (2-7 years of age on solution, 8-16 years of age on solution or 8-16 years of age on tablets),~* anticholinergic/antimuscarinic use (yes or no),~and using centered baseline detrusor compliance as covariate."||||0.7889
72487432|NCT00549939|144503322|SUPERIORITY_OR_OTHER|||||||0.7889||||||P-value was adjusted for multiplicity using the Hochberg procedure. The a priori threshold for statistical significance was 0.05.|ANCOVA|||||||0.7889
72487433|NCT03634397|144503344|OTHER||Mean Difference (Final Values)|5.73|||<|0.05|TWO_SIDED|95.0|2.31|9.14||P-values include adjustment for age, female sex, and hemisphere of brain affected by stroke.|Regression, Linear||The delta values of the outcome from baseline 2 to post-treatment 1 were directly modeled using linear regression with adjustment for age, female sex, and the hemisphere affected by the stroke.|||9.14|2.31|<.05
72487434|NCT03634397|144503346|OTHER|P-values include adjustment for age, female sex, and hemisphere of brain affected by stroke.|Mean Difference (Final Values)|0.83|||<|0.05|TWO_SIDED|95.0|-2.58|4.24||P-values include adjustment for age, female sex, and hemisphere of brain affected by stroke.|Regression, Linear|P-values include adjustment for age, female sex, and hemisphere of brain affected by stroke.||||4.24|-2.58|<.05
72514342|NCT00363246|144559367|SUPERIORITY_OR_OTHER|||||||0.013|TWO_SIDED||||||Chi-squared|||Pain in last 4 weeks (interference with daily activities). No Wheelchair-related Falls vs. Wheelchair-related Falls.||||0.013
72514343|NCT00363246|144559367|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Chi-squared|||Pain when transfer. No Wheelchair-related Falls vs. Wheelchair-related Falls.||||<0.001
72514344|NCT00363246|144559367|SUPERIORITY_OR_OTHER|||||||0.007|TWO_SIDED||||||t-test, 2 sided|||Energy level. No Wheelchair-related Falls vs. Wheelchair-related Falls.||||0.007
72514345|NCT00099359|144559385|SUPERIORITY_OR_OTHER|||||||0.046||||||Overall comparison of 3 KM curves using an extension of the M-H test was performed. Results indicated a significant difference therefore a 2nd stage analysis was done to compare each pair of transmission rates, using 2-sample Mantel-Haenzel tests.|multiple comparison|Hochberg's modified Bonferroni method was used to adjust the significance level for comparisons between arms.||||||.046
72403045|NCT00277212|144311976|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.24|||||TWO_SIDED|95.0|-0.03|0.51||Means, treatment differences between aripiprazole and placebo, 95% confidence intervals for the differences and the p-values for treatment comparisons are based on ANOVA/ANCOVA model.|ANCOVA|ANCOVA (main effects=double-blind treatment, covariate=baseline assessment) used for mean change from baseline comparisons.|aripiprazole - placebo|Change from baseline at Week 8||0.51|-0.03|
72487435|NCT03634397|144503347|OTHER|P-values include adjustment for age, female sex, and hemisphere of brain affected by stroke.|Median Difference (Final Values)|1.12|||<|0.05|TWO_SIDED|95.0|-2.29|4.53||P-values include adjustment for age, female sex, and hemisphere of brain affected by stroke.|Regression, Linear|P-values include adjustment for age, female sex, and hemisphere of brain affected by stroke.|P-values include adjustment for age, female sex, and hemisphere of brain affected by stroke.|||4.53|-2.29|<.05
72487436|NCT05197049|144503351|SUPERIORITY||Adjusted treatment difference:percentage|34.9|||<|0.001|TWO_SIDED|95.0|25.1|44.6|||Mantel Haenszel|Mantel-Haenszel stratum weights and the Sato variance estimator.||||44.6|25.1|< 0.001
72487437|NCT05197049|144503352|SUPERIORITY||Adjusted treatment difference:percentage|19.9|||<|0.001|TWO_SIDED|95.0|10.2|29.6|||Mantel Haenszel|Mantel-Haenszel stratum weights and the Sato variance estimator.||||29.6|10.2|< 0.001
72514346|NCT00099359|144559386|SUPERIORITY_OR_OTHER|||||||0.0001|||||||Chi-squared|||||||.0001
72514347|NCT00099359|144559387|SUPERIORITY_OR_OTHER|||||||0.2432|||||||multiple comparison|||||||.2432
72487438|NCT05197049|144503353|SUPERIORITY||Adjusted treatment difference:percentage|37.0|||<|0.001|TWO_SIDED|95.0|25.6|48.4|||Mantel Haenszel|Mantel-Haenszel stratum weights and the Sato variance estimator.||||48.4|25.6|< 0.001
72487439|NCT05197049|144503353|SUPERIORITY||Adjusted treatment difference:percentage|39.3|||<|0.001|TWO_SIDED|95.0|28.0|50.7|||Mantel Haenszel|Mantel-Haenszel stratum weights and the Sato variance estimator.||||50.7|28.0|< 0.001
72514348|NCT00099359|144559388|SUPERIORITY_OR_OTHER|||||||0.49|||||||Chi-squared|||||||0.49
72514349|NCT00099359|144559391|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.5||||0.05|TWO_SIDED|95.0|0.24|1.01|||Regression, Logistic|Adjusted Odds ratio for treatment arm C (ZDV+3TC/NFV) association with Intrapartum Infection Status with Treatment Arm A (ZDV only) as reference group||||1.01|0.24|0.05
72514350|NCT00099359|144559391|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.39||||0.01|TWO_SIDED|95.0|0.19|0.82||Adjusted odds ratio for association of treatment arm B (ZDV+NVP) with intrapartum infection status with Treatment Arm A (ZDV only) as reference.|Regression, Logistic|||||0.82|0.19|0.01
72514351|NCT00099359|144559391|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.51||||0.03|TWO_SIDED|95.0|1.08|5.86|||Regression, Logistic|"Adjusted odds ratio for association of illegal substance use during pregnancy and intrapartum HIV infection status with NO being reference group."||||5.86|1.08|0.03
72403046|NCT00277212|144311976|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.24|||||TWO_SIDED|95.0|-0.13|0.6||Means, treatment differences between aripiprazole and placebo, 95% confidence intervals for the differences and the p-values for treatment comparisons are based on ANOVA/ANCOVA model.|ANCOVA|ANCOVA (main effects=double-blind treatment, covariate=baseline assessment) used for mean change from baseline comparisons.|aripiprazole - placebo|Change from baseline at Week 24||0.60|-0.13|
72403047|NCT00277212|144311976|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.25|||||TWO_SIDED|95.0|-0.06|0.55||Means, treatment differences between aripiprazole and placebo, 95% confidence intervals for the differences and the p-values for treatment comparisons are based on ANOVA/ANCOVA model.|ANCOVA|ANCOVA (main effects=double-blind treatment, covariate=baseline assessment) used for mean change from baseline comparisons.|aripiprazole - placebo|Change from Baseline at Week 36||0.55|-0.06|
72403048|NCT00277212|144311976|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.29|||||TWO_SIDED|95.0|-0.06|0.65||Means, treatment differences between aripiprazole and placebo, 95% confidence intervals for the differences and the p-values for treatment comparisons are based on ANOVA/ANCOVA model.|ANCOVA|ANCOVA (main effects=double-blind treatment, covariate=baseline assessment) used for mean change from baseline comparisons.|aripiprazole - placebo|Change from baseline at Week 52||0.65|-0.06|
72403049|NCT00277212|144311976|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.24||||0.095|TWO_SIDED|95.0|-0.04|0.52||Means, treatment differences between aripiprazole and placebo, 95% confidence intervals for the differences and the p-values for treatment comparisons are based on ANOVA/ANCOVA model.|ANCOVA|ANCOVA (main effects=double-blind treatment, covariate=baseline assessment) used for mean change from baseline comparisons.|aripiprazole - placebo|Change from Baseline at Week 52 (LOCF)||0.52|-0.04|0.095
72403050|NCT00277212|144311976|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.31||||0.061|TWO_SIDED|95.0|-0.01|0.63||Means, treatment differences between aripiprazole and placebo, 95% confidence intervals for the differences and the p-values for treatment comparisons are based on ANOVA/ANCOVA model.|ANCOVA|ANCOVA (main effects=double-blind treatment, covariate=baseline assessment) used for mean change from baseline comparisons.|aripirazole - placebo|Highest change from Baseline||0.63|-0.01|0.061
72487440|NCT05197049|144503354|SUPERIORITY||Adjusted treatment difference:percentage|32.1|||<|0.001|TWO_SIDED|95.0|22.9|41.2|||Mantel Haenszel|Mantel-Haenszel stratum weights and the Sato variance estimator.||||41.2|22.9|< 0.001
72403051|NCT00277212|144311977|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.07||||0.458||95.0|-0.25|0.11||Means, treatment differences between aripiprazole and placebo, 95% confidence intervals for the differences and the p-values for treatment comparisons are based on ANOVA/ANCOVA model.|ANOVA|ANOVA model, controlling for treatment, is used for baseline estimates.|aripiprazole - placebo|Baseline||0.11|-0.25|0.458
72487441|NCT05197049|144503355|SUPERIORITY||Adjusted treatment difference:percentage|40.3|||<|0.001|TWO_SIDED|95.0|29.9|50.7|||Mantel Haenszel|Mantel-Haenszel stratum weights and the Sato variance estimator.||||50.7|29.9|< 0.001
72514352|NCT00099359|144559391|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.28|||<|0.0001|TWO_SIDED|95.0|1.56|3.35||Adjusted odds ratio for the association of continuous log10 viral load with intrapartum infection status|Regression, Logistic|||||3.35|1.56|<0.0001
72514353|NCT04501679|144559449|SUPERIORITY||Strata-adjusted percentage difference|37.4|||<|0.0001|TWO_SIDED|95.0|26.3|48.5||A 2-sided p-value was derived from Cochran-Mantel-Haenszel (CMH) test using the randomized stratification variables (analysis center and body weight at randomization \[\< 90 kg, \>= 90 kg\]). Threshold of significance at 0.05.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test using the randomized stratification variables (analysis center and body weight at randomization \[\<90 kg,\>=90 kg\]).|Strata adjusted percentage difference was obtained using weighted average of stratum-specific percentage using CMH.|A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measures were reported and continued when previous outcome measure was statistically significant at two-sided 0.05.||48.5|26.3|<0.0001
72577040|NCT00261443|144680754|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0||||0.808|TWO_SIDED|95.0|-0.03|0.04||ANOVA model, controlling for treatment and mood stabilizer, is used for baseline. ANCOVA model, controlling for treatment, mood stabilizer, and baseline value, is used for mean change from baseline.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences and p-values are based on the ANOVA/ANCOVA model.||Week 52 LOCF Treatment Difference||0.04|-0.03|0.808
72487442|NCT00309465|144503365|SUPERIORITY_OR_OTHER|||||||0.332||95.0||||P-value for three dosing strategies in insulin glargine only group in fasting blood glucose achievement of 100-179 mg/dl range.|Chi-squared|||Comparison for Target Blood Glucose Achievement of 100-179 mg/dl||||0.332
72487443|NCT00309465|144503365|SUPERIORITY_OR_OTHER|||||||0.294||95.0||||P value is for three strategies in insulin glargine plus bolus group for fasting blood glucose achievement of 100-179 mg/dl|Chi-squared|||Comparison for Target Achievement of blood glucose values of 100-179 mg/dl||||0.294
72403052|NCT00277212|144311977|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.11|||||TWO_SIDED|95.0|-0.05|0.26||Means, treatment differences between aripiprazole and placebo, 95% confidence intervals for the differences and the p-values for treatment comparisons are based on ANOVA/ANCOVA model.|ANCOVA|ANCOVA (main effects=double-blind treatment, covariate=baseline assessment) used for mean change from baseline comparisons.|aripiprazole - placebo|Change from Baseline at Week 8||0.26|-0.05|
72403053|NCT00277212|144311977|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.04|||||TWO_SIDED|95.0|-0.11|0.2||Means, treatment differences between aripiprazole and placebo, 95% confidence intervals for the differences and the p-values for treatment comparisons are based on ANOVA/ANCOVA model.|ANCOVA|ANCOVA (main effects=double-blind treatment, covariate=baseline assessment) used for mean change from baseline comparisons.|aripiprazole - placebo|Change from baseline at Week 24||0.20|-0.11|
72487444|NCT00309465|144503365|SUPERIORITY_OR_OTHER|||||||0.162||95.0||||P value is for three strategies in insulin glargine only group for achievement of 80-249 mg/dl|Chi-squared|||Comparison of Achievement of blood glucose values of 80-249 mg/dl||||0.162
72487445|NCT00309465|144503365|SUPERIORITY_OR_OTHER|||||||0.031||95.0||||P value is for three strategies in insulin glargine plus bolus group in achievement of fasting blood glucose value of 80-249 mg/dl.|Chi-squared|||Comparison of Achievement of blood glucose values of 80-249 mg/dl.||||0.031
72487446|NCT02577406|144503380|SUPERIORITY||Hazard Ratio (HR)|0.86||||0.2288|TWO_SIDED|95.0|0.67|1.1|||Stratified Log Rank||The hazard ratio was from a Cox proportional hazards model stratified by prior intensive therapy for AML and primary refractory|||1.10|0.67|0.2288
72487447|NCT02577406|144503381|SUPERIORITY||Odds Ratio (OR)|6.08|||<|0.0001|TWO_SIDED|95.0|3.32|11.14||p-value from a Cochran-Mantel-Haenszel test comparing the response rates between the AG-221 group and the combined CCR group with stratification factors of prior intensive therapy for AML and primary refractory status|Cochran-Mantel-Haenszel||Odds ratio from logistic regression|||11.14|3.32|<0.0001
72487448|NCT02577406|144503382|SUPERIORITY||Hazard Ratio (HR)|0.72||||0.02|TWO_SIDED|95.0|0.55|0.95|||Stratified Log Rank||The hazard ratio is from a Cox proportional hazards model stratified by prior intensive therapy for AML and primary refractory status.|||0.95|0.55|0.0200
72487449|NCT02577406|144503388|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||||||<0.0001
72487450|NCT02577406|144503389|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||||||<0.0001
72487451|NCT02577406|144503390|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||||||<0.0001
72487452|NCT02577406|144503392|SUPERIORITY||Hazard Ratio (HR)|0.53|||<|0.0001|TWO_SIDED|95.0|0.41|0.67|||Stratified Log Rank||The hazard ratio was from a Cox proportional hazards model stratified by prior intensive therapy for AML and primary refractory status|||0.67|0.41|<0.0001
72514354|NCT04501679|144559450|SUPERIORITY||Strata-adjusted percentage difference|28.5|||<|0.0001|TWO_SIDED|95.0|18.8|38.2||A 2-sided p-value was derived from Cochran-Mantel-Haenszel (CMH) test using the randomized stratification variables (analysis center and body weight at randomization \[\< 90 kg, \>= 90 kg\]). Threshold of significance at 0.05.|Cochran-Mantel-Haenszel||Strata adjusted percentage difference was obtained using weighted average of stratum-specific percentage using CMH.|A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measures were reported and continued when previous outcome measure was statistically significant at two-sided 0.05.||38.2|18.8|<0.0001
72514355|NCT04501679|144559451|SUPERIORITY||Strata-adjusted percentage difference|33.4|||<|0.0001|TWO_SIDED|95.0|24.3|42.4||A 2-sided p-value was derived from Cochran-Mantel-Haenszel (CMH) test using the randomized stratification variables (analysis center and body weight at randomization \[\< 90 kg, \>= 90 kg\]). Threshold of significance at 0.05.|Cochran-Mantel-Haenszel||Strata adjusted percentage difference was obtained using weighted average of stratum-specific percentage using CMH.|A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measures were reported and continued when previous outcome measure was statistically significant at two-sided 0.05.||42.4|24.3|<0.0001
72403054|NCT00277212|144311977|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.21|||||TWO_SIDED|95.0|0.0|0.42||Means, treatment differences between aripiprazole and placebo, 95% confidence intervals for the differences and the p-values for treatment comparisons are based on ANOVA/ANCOVA model.|ANCOVA|ANCOVA (main effects=double-blind treatment, covariate=baseline assessment) used for mean change from baseline comparisons.|aripiprazole - placebo|Change from Baseline at Week 36||0.42|0.00|
72577041|NCT00261443|144680754|SUPERIORITY_OR_OTHER_LEGACY|||||||0.771||95.0||||ANOVA model, controlling for treatment and mood stabilizer, is used for baseline. ANCOVA model, controlling for treatment, mood stabilizer, and baseline value, is used for mean change from baseline.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences and p-values are based on the ANOVA/ANCOVA model.||Highest Value of Change Treatment Difference||||0.771
72487453|NCT04033445|144503404|SUPERIORITY||Adjusted treatment difference|33.6|||<|0.001|TWO_SIDED|95.0|20.9|46.3|||Cochran-Mantel-Haenszel (CMH) chi-square||Treatment difference between guselkumab group and placebo group was adjusted with CMH weight.|||46.3|20.9|< 0.001
72487454|NCT04033445|144503404|SUPERIORITY||Adjusted treatment difference|33.1|||<|0.001|TWO_SIDED|95.0|20.8|45.4|||CMH chi-square test||Treatment difference between guselkumab group and placebo group was adjusted with CMH weight.|||45.4|20.8|< 0.001
72487455|NCT04033445|144503405|SUPERIORITY||Adjusted treatment difference|14.9|||<|0.001|TWO_SIDED|95.0|9.9|19.9|||CMH chi-square test||Treatment difference between guselkumab group and placebo group was adjusted with CMH weight.|||19.9|9.9|< 0.001
72487456|NCT04033445|144503406|SUPERIORITY||Adjusted treatment difference|25.2|||<|0.001|TWO_SIDED|95.0|16.4|33.9|||Cochran-Mantel-Haenszel||Treatment difference between guselkumab group and placebo group was adjusted with CMH weight.|||33.9|16.4|< 0.001
72487457|NCT04033445|144503406|SUPERIORITY||Adjusted treatment difference|29.5|||<|0.001|TWO_SIDED|95.0|20.9|38.1|||Cochran-Mantel-Haenszel||Treatment difference between guselkumab group and placebo group was adjusted with CMH weight.|||38.1|20.9|< 0.001
72487458|NCT04754802|144503443|SUPERIORITY||Mean Difference (Net)|1.6|STANDARD_ERROR_OF_MEAN|2.42||0.5063|TWO_SIDED|95.0|-3.2|6.4|||ANCOVA|||||6.4|-3.2|.5063
72487459|NCT04754802|144503444|SUPERIORITY||Other|-0.015||||0.8077|TWO_SIDED|95.0|-0.137|0.107|||Wald Normal Approximation (Z)|Wald Normal Approximation (Z) for difference between two proportions||||0.107|-0.137|.8077
72487460|NCT04451161|144503445|SUPERIORITY|||||||0.591||||||We performed a chi-squared analysis comparing the study groups (BASIS vs. Attention Control) on whether participants administered the CPSS-V to at least one student beginning of the active phase.|Chi-squared|||The primary TF-CBT adoption outcome (defined as administered CPSS-V) was binary: either the participant adopted at least one of these components with a student, or they did not at the beginning of the active phase. A chi-squared test was used as a superiority test to determine whether participants in the BASIS group had higher TF-CBT adoption rates compared to the Attention Control group.||||0.591
72487461|NCT04451161|144503445|SUPERIORITY|||||||0.032||||||We performed a chi-squared analysis comparing the study groups (BASIS vs. Attention Control) on whether participants administered the CPSS-V to at least one student by the end of the active phase.|Chi-squared|||The primary TF-CBT adoption outcome (defined as administered CPSS-V) was binary: either the participant adopted at least one of these components with a student, or they did not by the end of the active phase. A chi-squared test was used as a superiority test to determine whether participants in the BASIS group had higher TF-CBT adoption rates compared to the Attention Control group.||||0.032
72487462|NCT04451161|144503445|SUPERIORITY|||||||0.054||||||We performed a chi-squared analysis comparing the study groups (BASIS vs. Attention Control) on whether participants administered the CPSS-V to at least one student by the end of the sustainment phase.|Chi-squared|||One of the primary TF-CBT adoption outcomes (defined as administered CPSS-V) was binary: either the participant adopted at least one of these components with a student at the end of the sustainment phase, or they did not. A chi-squared test was used as a superiority test to determine whether participants in the BASIS group had higher TF-CBT adoption rates compared to the Attention Control group.||||0.054
72624148|NCT01892189|144778533|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1935|STANDARD_ERROR_OF_MEAN|0.13599||0.164|TWO_SIDED|95.0|-0.4699|0.0828|||ANOVA||Difference between least square means of TAK-063 30 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Left Hippocampus: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.0828|-0.4699|0.164
72624149|NCT01892189|144778533|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1446|STANDARD_ERROR_OF_MEAN|0.13315||0.285|TWO_SIDED|95.0|-0.4152|0.126|||ANOVA||Difference between least square means of TAK-063 3 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Right Hippocampus: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.1260|-0.4152|0.285
72487463|NCT04451161|144503445|SUPERIORITY|||||||0.98||||||We performed a chi-squared analysis comparing the study groups (BASIS vs. Attention Control) on whether participants started TF-CBT with at least one student at the beginning of the active phase.|Chi-squared|||The primary TF-CBT adoption outcome (defined as started TF-CBT) was binary: either the participant adopted at least one of these components with a student, or they did not at the beginning of the active phase. A chi-squared test was used as a superiority test to determine whether participants in the BASIS group had higher TF-CBT adoption rates compared to the Attention Control group.||||0.98
72624150|NCT01892189|144778533|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.0176|STANDARD_ERROR_OF_MEAN|0.14368||0.903|TWO_SIDED|95.0|-0.3096|0.2744|||ANOVA||Difference between least square means of TAK-063 10 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Right Hippocampus: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.2744|-0.3096|0.903
72624151|NCT01892189|144778533|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1615|STANDARD_ERROR_OF_MEAN|0.13647||0.245|TWO_SIDED|95.0|-0.4388|0.1159|||ANOVA||Difference between least square means of TAK-063 30 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Right Hippocampus: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.1159|-0.4388|0.245
72624152|NCT01892189|144778533|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3659|STANDARD_ERROR_OF_MEAN|0.45708||0.429|TWO_SIDED|95.0|-0.563|1.2948|||ANOVA||Difference between least square means of TAK-063 3 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Left Subgenual Cingulate/BA25: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||1.2948|-0.5630|0.429
72624153|NCT01892189|144778533|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0395|STANDARD_ERROR_OF_MEAN|0.49321||0.937|TWO_SIDED|95.0|-0.9628|1.0419|||ANOVA||Difference between least square means of TAK-063 10 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Left Subgenual Cingulate/BA25: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||1.0419|-0.9628|0.937
72624154|NCT01892189|144778533|SUPERIORITY_OR_OTHER||LS Mean Difference|0.7902|STANDARD_ERROR_OF_MEAN|0.46847||0.101|TWO_SIDED|95.0|-0.1618|1.7423|||ANOVA||Difference between least square means of TAK-063 30 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Left Subgenual Cingulate/BA25: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||1.7423|-0.1618|0.101
72624155|NCT01892189|144778533|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4404|STANDARD_ERROR_OF_MEAN|0.43756||0.321|TWO_SIDED|95.0|-1.3296|0.4488|||ANOVA||Difference between least square means of TAK-063 3 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Right Subgenual Cingulate/BA25: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.4488|-1.3296|0.321
72624156|NCT01892189|144778533|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4685|STANDARD_ERROR_OF_MEAN|0.47214||0.328|TWO_SIDED|95.0|-1.428|0.491|||ANOVA||Difference between least square means of TAK-063 10 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Right Subgenual Cingulate/BA25: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.4910|-1.4280|0.328
72369264|NCT00611026|144248563|SUPERIORITY_OR_OTHER|||||||0.0828|TWO_SIDED|||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with terms for country and treatment and ranked baseline value as a covariate.||Treatment difference fesoterodine vs placebo at Week 1.||||0.0828
72487464|NCT04451161|144503445|SUPERIORITY|||||||0.068||||||We performed a chi-squared analysis comparing the study groups (BASIS vs. Attention Control) on whether participants started TF-CBT with at least one student by the end of the active phase.|Chi-squared|||The primary TF-CBT adoption outcome (defined as started TF-CBT) was binary: either the participant adopted at least one of these components with a student, or they did not by the end of the active phase. A chi-squared test was used as a superiority test to determine whether participants in the BASIS group had higher TF-CBT adoption rates compared to the Attention Control group.||||0.068
72624157|NCT01892189|144778533|SUPERIORITY_OR_OTHER||LS Mean Difference|0.42|STANDARD_ERROR_OF_MEAN|0.44846||0.356|TWO_SIDED|95.0|-0.4914|1.3314|||ANOVA||Difference between least square means of TAK-063 30 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Right Subgenual Cingulate/BA25: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||1.3314|-0.4914|0.356
72624158|NCT01892189|144778533|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2254|STANDARD_ERROR_OF_MEAN|0.1679||0.188|TWO_SIDED|95.0|-0.5666|0.1158|||ANOVA||Difference between least square means of TAK-063 3 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Left Paracingulte gyrus/BA32. Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.1158|-0.5666|0.188
72624159|NCT01892189|144778533|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.0232|STANDARD_ERROR_OF_MEAN|0.18117||0.899|TWO_SIDED|95.0|-0.3914|0.3449|||ANOVA||Difference between least square means of TAK-063 10 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Left Paracingulte gyrus/BA32: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.3449|-0.3914|0.899
72403055|NCT00277212|144311977|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.06|||||TWO_SIDED|95.0|-0.05|0.16||Means, treatment differences between aripiprazole and placebo, 95% confidence intervals for the differences and the p-values for treatment comparisons are based on ANOVA/ANCOVA model.|ANCOVA|ANCOVA (main effects=double-blind treatment, covariate=baseline assessment) used for mean change from baseline comparisons.|aripiprazole - placebo|Change from Baseline at week 52||0.16|-0.05|
72403056|NCT00277212|144311977|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.05||||0.515|TWO_SIDED|95.0|-0.22|0.11||Means, treatment differences between aripiprazole and placebo, 95% confidence intervals for the differences and the p-values for treatment comparisons are based on ANOVA/ANCOVA model.|ANCOVA|ANCOVA (main effects=double-blind treatment, covariate=baseline assessment) used for mean change from baseline comparisons.|aripiprazole - placebo|Change from baseline at Week 52 (LOCF)||0.11|-0.22|0.515
72403057|NCT00277212|144311977|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.03||||0.73|TWO_SIDED|95.0|-0.16|0.23||Means, treatment differences between aripiprazole and placebo, 95% confidence intervals for the differences and the p-values for treatment comparisons are based on ANOVA/ANCOVA model.|ANCOVA|ANCOVA (main effects=double-blind treatment, covariate=baseline assessment) used for mean change from baseline comparisons.|aripiprazole - placebo|Highest Change from Baseline||0.23|-0.16|0.730
72403058|NCT00277212|144311978|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.06||||0.435|TWO_SIDED|95.0|-0.08|0.2||Means, mean differences, 95% confidence intervals for the differences, and the p-values are based on ANOVA/ANCOVA model.|ANOVA|ANOVA, controlling for treatment, used for baseline estimates.|aripiprazole - placebo|Baseline||0.20|-0.08|0.435
72403059|NCT00277212|144311978|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.17|||||TWO_SIDED|95.0|0.04|0.3||Means, treatment differences between aripiprazole and placebo, 95% confidence intervals for the differences and the p-values for treatment comparisons are based on ANOVA/ANCOVA model.|ANCOVA|ANCOVA (main effects=double-blind treatment, covariate=baseline assessment) used for mean change from baseline comparisons.|aripiprazole - placebo|Change from Baseline at Week 8||0.30|0.04|
72403060|NCT00277212|144311978|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.03|||||TWO_SIDED|95.0|-0.11|0.17||Means, treatment differences between aripiprazole and placebo, 95% confidence intervals for the differences and the p-values for treatment comparisons are based on ANOVA/ANCOVA model.|ANCOVA|ANCOVA (main effects=double-blind treatment, covariate=baseline assessment) used for mean change from baseline comparisons.|aripiprazole - placebo|Change from Baseline at Week 24||0.17|-0.11|
72487465|NCT04451161|144503445|SUPERIORITY|||||||0.165||||||We performed a chi-squared analysis comparing the study groups (BASIS vs. Attention Control) on whether participants started TF-CBT with at least one student by the end of the sustainment phase.|Chi-squared|||The primary TF-CBT adoption outcome (defined as started TF-CBT) was binary: either the participant adopted at least one of these components with a student, or they did not by the end of the sustainment phase. A chi-squared test was used as a superiority test to determine whether participants in the BASIS group had higher TF-CBT adoption rates compared to the Attention Control group.||||0.165
72487466|NCT04451161|144503445|SUPERIORITY|||||||0.191||||||We performed a chi-squared analysis comparing the study groups (BASIS vs. Attention Control) on whether participants completed TF-CBT with at least one student by the end of the active phase.|Chi-squared|||The primary TF-CBT adoption outcome (defined as completed TF-CBT) was binary: either the participant adopted at least one of these components with a student, or they did not by the end of the active phase. A chi-squared test was used as a superiority test to determine whether participants in the BASIS group had higher TF-CBT adoption rates compared to the Attention Control group.||||0.191
72487467|NCT04451161|144503445|SUPERIORITY|||||||0.86||||||We performed a chi-squared analysis comparing the study groups (BASIS vs. Attention Control) on whether participants completed TF-CBT with at least one student at the end of the sustainment phase.|Chi-squared|||The primary TF-CBT adoption outcome (defined as completed TF-CBT) was binary: either the participant adopted at least one of these components with a student, or they did not by the end of the sustainment phase. A chi-squared test was used as a superiority test to determine whether participants in the BASIS group had higher TF-CBT adoption rates compared to the Attention Control group.||||0.86
72514356|NCT04501679|144559452|SUPERIORITY||Strata-adjusted percentage difference|30.0|||<|0.0001|TWO_SIDED|95.0|21.3|38.6||A 2-sided p-value was derived from Cochran-Mantel-Haenszel (CMH) test using the randomized stratification variables (analysis center and body weight at randomization \[\< 90 kg, \>= 90 kg\]). Threshold of significance at 0.05.|Cochran-Mantel-Haenszel|CMH test using the randomized stratification variables (analysis center and body weight at randomization \[\<90 kg,\>=90 kg\]).|Strata adjusted percentage difference was obtained using weighted average of stratum-specific percentage using CMH.|A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measures were reported and continued when previous outcome measure was statistically significant at two-sided 0.05.||38.6|21.3|<0.0001
72514357|NCT04501679|144559453|SUPERIORITY||Strata-adjusted percentage difference|31.9|||<|0.0001|TWO_SIDED|95.0|20.7|43.2||A 2-sided p-value was derived from Cochran-Mantel-Haenszel (CMH) test using the randomized stratification variables (analysis center and body weight at randomization \[\< 90 kg, \>= 90 kg\]). Threshold of significance at 0.05.|Cochran-Mantel-Haenszel|CMH test using the randomized stratification variables (analysis center and body weight at randomization \[\<90 kg,\>=90 kg\]).|Strata adjusted percentage difference was obtained using weighted average of stratum-specific percentage using CMH.|A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measures were reported and continued when previous outcome measure was statistically significant at two-sided 0.05.||43.2|20.7|<0.0001
72403061|NCT00277212|144311978|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|||||TWO_SIDED|95.0|-0.13|0.13||Means, treatment differences between aripiprazole and placebo, 95% confidence intervals for the differences and the p-values for treatment comparisons are based on ANOVA/ANCOVA model.|ANCOVA|ANCOVA (main effects=double-blind treatment, covariate=baseline assessment) used for mean change from baseline comparisons.|aripiprazole - placebo|Change from baseline at Week 36||0.13|-0.13|
72403062|NCT00277212|144311978|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.03|||||TWO_SIDED|95.0|-0.08|0.14||Means, treatment differences between aripiprazole and placebo, 95% confidence intervals for the differences and the p-values for treatment comparisons are based on ANOVA/ANCOVA model.|ANCOVA|ANCOVA (main effects=double-blind treatment, covariate=baseline assessment) used for mean change from baseline comparisons.|aripiprazole - placebo|Change from baseline at Week 52||0.14|-0.08|
72487468|NCT04451161|144503446|SUPERIORITY||Slope|3.425|STANDARD_ERROR_OF_MEAN|2.783||0.22|TWO_SIDED|95.0|-2.064|8.915||Mixed model analysis was used (students were clustered under the providers who recruited them) to understand if BASIS+TF-CBT has a greater effect on decreasing trauma PTSD symptoms (measured using CPSS-V) over time.|Mixed Models Analysis|||We compared the BASIS group (receiving TF-CBT) against Enhanced Treatment as Usual to evaluate whether TF-CBT reduced trauma-related PTSD symptoms over time, as measured by CPSS-V scores (higher scores indicate greater symptom severity).||8.915|-2.064|0.22
72487469|NCT04451161|144503446|SUPERIORITY||Slope|4.97|STANDARD_ERROR_OF_MEAN|2.774||0.075|TWO_SIDED|95.0|-0.502|10.443||Mixed model analysis was used (the students were clustered under the providers who recruited them) to understand if AC+TF-CBT has a greater effect on decreasing trauma PTSD symptoms (measured using CPSS-V) over time.|Mixed Models Analysis|||We compared the AC group (receiving TF-CBT) against Enhanced Treatment as Usual to evaluate whether TF-CBT reduced trauma-related PTSD symptoms over time, as measured by CPSS-V scores (higher scores indicate greater symptom severity).||10.443|-.502|0.075
72487470|NCT04451161|144503447|SUPERIORITY||Slope|1.024|STANDARD_ERROR_OF_MEAN|0.952||0.284|TWO_SIDED|95.0|-0.855|2.904||Mixed model analysis was used (students were clustered under the providers who recruited them) to understand if BASIS+TF-CBT has a greater effect on decreasing negative mood and feelings symptoms (measured using SMFQ) over time.|Mixed Models Analysis|||We compared the BASIS group (receiving TF-CBT) against Enhanced Treatment as Usual to evaluate whether TF-CBT decreased children's negative moods and feelings due to their trauma (higher score indicates more negative mood and feelings).||2.904|-.855|0.284
72487471|NCT04451161|144503447|SUPERIORITY||Slope|1.908|STANDARD_ERROR_OF_MEAN|0.951||0.046|TWO_SIDED|95.0|0.03|3.786||Mixed model analysis was used (students were clustered under the providers who recruited them) to understand if AC+TF-CBT has a greater effect on decreasing negative mood and feelings symptoms (measured using SMFQ) over time.|Mixed Models Analysis|||We compared the AC group (receiving TF-CBT) against Enhanced Treatment as Usual to evaluate whether TF-CBT decreased children's negative moods and feelings due to their trauma (higher score indicates more negative mood and feelings).||3.786|.03|.046
72487472|NCT01671111|144503453|SUPERIORITY_OR_OTHER_LEGACY|||||||0.056|TWO_SIDED|||||P-value was from paired t-test for post treatment timepoint versus baseline.|paired t-test|||||||0.0560
72542483|NCT00106028|144614698|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.682||||0.682|TWO_SIDED|95.0|0.304|1.532||Other Non-Vertebral Fracture|Wald Test|Hazard Ratio and 95% CI based on Anderson-Gill mean intensity model stratified by age group with treatment and pooled-country as covariates.||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.||1.532|0.304|0.682
72567978|NCT02037165|144667471|SUPERIORITY_OR_OTHER||adjusted mean difference|-0.57|STANDARD_ERROR_OF_MEAN|1.1751|||TWO_SIDED|95.0|-2.9|1.7|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 5:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||1.7|-2.9|
72567979|NCT02037165|144667471|SUPERIORITY_OR_OTHER||adjusted mean difference|-1.43|STANDARD_ERROR_OF_MEAN|1.1752|||TWO_SIDED|95.0|-3.7|0.9|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 6:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||0.9|-3.7|
72403063|NCT00277212|144311978|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.05||||0.358|TWO_SIDED|95.0|-0.06|0.17||Means, treatment differences between aripiprazole and placebo, 95% confidence intervals for the differences and the p-values for treatment comparisons are based on ANOVA/ANCOVA model.|ANCOVA|ANCOVA (main effects=double-blind treatment, covariate=baseline assessment) used for mean change from baseline comparisons.|aripiprazole - placebo|Change from Baseline at Week 52 (LOCF)||0.17|-0.06|0.358
72487473|NCT01671111|144503454|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1232|TWO_SIDED|||||P-value was from paired t-test for post treatment timepoint versus baseline.|paired t-test|||||||0.1232
72487474|NCT01671111|144503455|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1319|TWO_SIDED|||||P-value was from paired t-test for post treatment timepoint versus baseline.|paired t-test|||||||0.1319
72487475|NCT01671111|144503456|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8061|TWO_SIDED|||||P-value was from paired t-test for log-transformed data at post treatment timepoint versus baseline.|paired t-test|||||||0.8061
72487476|NCT01671111|144503457|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2297|TWO_SIDED|||||P-value was from paired t-test for log-transformed data at post treatment timepoint versus baseline.|paired t-test|||||||0.2297
72487477|NCT01671111|144503458|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1248|TWO_SIDED|||||P-value was from paired t-test for log-transformed data at post treatment timepoint versus baseline.|paired t-test|||||||0.1248
72487478|NCT02504554|144503488|OTHER||||||<|0.001||||||"no adjustment for multiple hypothesis testing since this was an exploratory study.~the p-value listed is the actual result from analysis of the study data."|Wilcoxon (Mann-Whitney)|||Wilcoxon signed rank analysis of symptoms at 10 weeks (end of treatment) vs. baseline||||<0.001
72487479|NCT02504554|144503489|OTHER|paired 2-sided t-test comparing baseline and 10 weeks (end of treatment)|||||<|0.001||||||no adjustment for multiple comparisons|t-test, 2 sided|paired t-test, 2 sided||||||<0.001
72487480|NCT02504554|144503491|OTHER||||||<|0.001||||||"no adjustment for multiple comparisons~The p-value listed is the result for the actual analysis of the data."|Wilcoxon (Mann-Whitney)|||Wilcoxon signed-rank test comparing the baseline score vs. the score at 10 weeks (end of treatment).||||<0.001
72487481|NCT02504554|144503492|OTHER||||||<|0.001||||||"no adjustment for multiple comparisons~the p-value listed is the actual result for the study results."|Wilcoxon (Mann-Whitney)|||Wilcoxon signed-rank test comparing scores at baseline vs. 10 weeks (end of treatment)||||<0.001
72487482|NCT02504554|144503494|OTHER||||||<|0.001||||||"no adjustment for multiple comparisons~the p-value listed is the actual result for the analysis of the study data"|t-test, 2 sided|||2-sided t-test comparing the group at baseline vs. 18 weeks (8 weeks after end of treatment)||||<0.001
72487483|NCT02504554|144503495|OTHER|||||||0.002||||||no adjustment for multiple comparisons|Wilcoxon (Mann-Whitney)|||Wilcoxon signed rank test was used to compare scores at baseline vs. at 10 weeks (end of treatment)||||0.002
72487484|NCT01806857|144503496|SUPERIORITY_OR_OTHER|||||||0.0003|||||||Random Effects Model|||||||0.0003
72487485|NCT01806857|144503500|SUPERIORITY_OR_OTHER|||||||0.0001|||||||Random Effects Model|||||||0.0001
72487486|NCT01020591|144503512|NON_INFERIORITY_OR_EQUIVALENCE|The power and sample size calculations, based on the ability to detect treatment and evaluation group differences, were performed on Minitab™ V.15. 40 participants were estimated to be required for group allocation (20 in each group: evaluation;evaluation and treatment)for 80% power in at least 3 out of the 4 outcome measures. After 30 subjects, analysis determined that there would be no further statistically significant changes in results therefore, data collection was stopped at 30 subjects.|||||<|0.05|TWO_SIDED|95.0|||||ANOVA|||A two factor mixed model Analysis of Variance (ANOVA) for Group (Evaluation vs. Treatment) with repeated measures (pre vs. post test) was employed to test for main effects and all interactions for the Resistive Index||||<0.05
72487487|NCT00698997|144503526|OTHER|Non- equivalence.|slope difference|1.01||||0.03|TWO_SIDED||||||Mixed Models Analysis|||We used a generalized linear mixed model (GLMM). Change-over-Time was modeled as a linear within-subject effect of time across all observed data for each participant. We fit splines to manage the differing lengths of time in parent-training versus direct treatment. In all analyses, site was included as a categorical covariate to account for potential differences. Effect sizes were reported following Cohen's recommendations as f2.||||.03
72487488|NCT04272892|144503555|SUPERIORITY||Mean Difference (Final Values)|3.35|||<|0.021|TWO_SIDED|||||p values are calculated for original data (complete case) and each of the 5 imputed datasets. The p value range was 0.002 - 0.020. This is not multiple statistical analyses- it is just one with multiple imputations.|ANCOVA|Degrees of freedom for original data (complete case): 1,64. Degrees of freedom for imputed datasets: 1,80||||||<0.021
72487489|NCT04272892|144503556|SUPERIORITY||Mean Difference (Final Values)|2.86||||0.059|TWO_SIDED|95.0|-0.106|5.822|||ANCOVA|ANCOVA of score at 8 week follow up with baseline score as covariate, effect of group||||5.822|-.106|0.059
72487490|NCT04272892|144503557|SUPERIORITY||Mean Difference (Final Values)|1.3||||0.596|TWO_SIDED|95.0|-3.5|6.0|||ANCOVA|ANCOVA of sleep fragmentation at post-intervention with baseline as covariate, effect of group||||6.0|-3.5|0.596
72487491|NCT04272892|144503558|SUPERIORITY||Mean Difference (Final Values)|4.5||||0.031|TWO_SIDED|95.0|0.431|8.612|||ANCOVA|ANCOVA of sleep fragmentation at 8 week follow up with baseline as covariate, effect of group||||8.612|.431|0.031
72487492|NCT04272892|144503559|SUPERIORITY||Mean Difference (Final Values)|0.6||||0.885|TWO_SIDED|95.0|-7.8|9.1|||ANCOVA|ANCOVA of wake after sleep onset post-intervention with baseline as covariate, effect of group||||9.1|-7.8|0.885
72487493|NCT04272892|144503560|SUPERIORITY||Mean Difference (Final Values)|8.0||||0.077|TWO_SIDED|95.0|-1.0|17.0|||ANCOVA|ANCOVA of wake after sleep onset at 8 week follow up with baseline as covariate, effect of group||||17|-1|0.077
72487494|NCT04272892|144503561|SUPERIORITY||Mean Difference (Final Values)|10.0||||0.014|TWO_SIDED|95.0|2.0|18.0|||ANCOVA|ANCOVA of sleep onset latency (median of 7 nights) at end of intervention with baseline as covariate, effect of group||||18|2|0.014
72487495|NCT04272892|144503562|SUPERIORITY||Mean Difference (Final Values)|1.8||||0.03|TWO_SIDED|95.0|0.18|3.5|||ANCOVA|ANCOVA of PHQ9 score post-intervention with baseline as covariate, effect of group||||3.5|.18|0.03
72487496|NCT04272892|144503563|SUPERIORITY||Mean Difference (Final Values)|2.29||||0.036|TWO_SIDED|95.0|0.149|4.44|||ANCOVA|ANCOVA of PHQ9 score at 8 week follow up with baseline as covariate, effect of group||||4.44|.149|0.036
72487497|NCT04272892|144503564|SUPERIORITY||Mean Difference (Final Values)|1.61||||0.054|TWO_SIDED|95.0|-0.03|3.25|||ANCOVA|ANCOVA of GAD7 post-intervention, with baseline as covariate, effect of group||||3.25|-0.03|0.054
72487498|NCT04272892|144503565|SUPERIORITY||Mean Difference (Final Values)|1.09||||0.229|TWO_SIDED|95.0|-0.7|2.87|||ANCOVA|ANCOVA of GAD7 at 8 week follow up, with baseline as covariate, effect of group||||2.87|-.70|0.229
72487499|NCT04272892|144503566|SUPERIORITY||Mean Difference (Final Values)|-1.39||||0.502|TWO_SIDED|95.0|-5.51|2.73|||ANCOVA|ANCOVA of SIS index at post-intervention, with baseline as covariate, effect of group||||2.73|-5.51|0.502
72487500|NCT04272892|144503567|SUPERIORITY||Mean Difference (Final Values)|0.183||||0.924|TWO_SIDED|95.0|-3.63|4.0|||ANCOVA|ANCOVA of SIS index at 8 week follow up, with baseline as covariate, effect of group||||4.0|-3.63|0.924
72514358|NCT04501679|144559454|SUPERIORITY|A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measures were reported and continued when previous outcome measure was statistically significant at two-sided 0.05.|Strata-adjusted percentage difference|27.9|||<|0.0001|TWO_SIDED|95.0|18.4|37.5||A 2-sided p-value was derived from Cochran-Mantel-Haenszel (CMH) test using the randomized stratification variables (analysis center and body weight at randomization \[\< 90 kg, \>= 90 kg\]). Threshold of significance at 0.05.|Cochran-Mantel-Haenszel||Strata adjusted percentage difference was obtained using weighted average of stratum-specific percentage using CMH.|||37.5|18.4|<0.0001
72514359|NCT04501679|144559455|SUPERIORITY||Strata-adjusted percentage difference|18.8|||<|0.0001|TWO_SIDED|95.0|12.0|25.7||A 2-sided p-value was derived from Cochran-Mantel-Haenszel (CMH) test using the randomized stratification variables (analysis center and body weight at randomization \[\< 90 kg, \>= 90 kg\]). Threshold of significance at 0.05.|Cochran-Mantel-Haenszel||Strata adjusted percentage difference was obtained using weighted average of stratum-specific percentage using CMH.|A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measures were reported and continued when previous outcome measure was statistically significant at two-sided 0.05.||25.7|12.0|<0.0001
72403064|NCT00277212|144311978|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.17||||0.021|TWO_SIDED|95.0|0.03|0.31||Means, treatment differences between aripiprazole and placebo, 95% confidence intervals for the differences and the p-values for treatment comparisons are based on ANOVA/ANCOVA model.|ANCOVA|ANCOVA (main effects=double-blind treatment, covariate=baseline assessment) used for mean change from baseline comparisons.|aripiprazole - placebo|Highest Change from Baseline||0.31|0.03|0.021
72514360|NCT00186056|144559461|SUPERIORITY_OR_OTHER||||||<|0.26|||||||ANOVA|Interaction of HAMD \* medication group F(2,26)=1.38, eta sq = .05||||||<.26
72514361|NCT05027516|144559485|SUPERIORITY||Ratio|1.05||||0.1026|TWO_SIDED|95.0|0.55|1.83|||Permutation testing|||||1.83|0.55|0.1026
72514362|NCT05027516|144559486|SUPERIORITY||Ratio|1.12||||1|TWO_SIDED|95.0|0.47|2.19|||Permutation testing|||For aminoglycosides||2.19|0.47|1
72514363|NCT05027516|144559486|SUPERIORITY||Ratio|1.01||||1|TWO_SIDED|95.0|0.69|1.44|||Permutation testing|||For betalactams||1.44|0.69|1
72514364|NCT05027516|144559486|SUPERIORITY||Ratio|3.79||||1|TWO_SIDED|95.0|0.05|20.15|||Permutation testing|||For bacitracin||20.15|0.05|1
72514365|NCT05027516|144559486|SUPERIORITY||Ratio|0.83||||1|TWO_SIDED|95.0|0.0|1.91|||Permutation testing|||For glycopeptides||1.91|0|1
72514366|NCT05027516|144559486|SUPERIORITY||Ratio|1.19||||1|TWO_SIDED|95.0|0.32|3.15|||Permutation testing|||For trimethoprim||3.15|0.32|1
72514367|NCT05027516|144559486|SUPERIORITY||Ratio|2.82||||1|TWO_SIDED|95.0|0.07|14.64|||Permutation testing|||For cationic antimicrobial peptides||14.64|0.07|1
72514368|NCT05027516|144559486|SUPERIORITY||Ratio|1.49||||1|TWO_SIDED|95.0|0.0|5.34|||Permutation testing|||For mupirocin||5.34|0|1
72514369|NCT05027516|144559486|SUPERIORITY||Ratio|1.2||||1|TWO_SIDED|95.0|0.0|3.22|||Permutation testing|||For metronidazole||3.22|0|1
72514370|NCT05027516|144559486|SUPERIORITY||Ratio|6.44||||1|TWO_SIDED|95.0|0.02|46.02|||Permutation testing|||For fluoroquinolones||46.02|0.02|1
72514371|NCT05027516|144559486|SUPERIORITY||Ratio|10.6||||1|TWO_SIDED|95.0|0.01|148.86|||Permutation testing|||For sulfonamides||148.86|0.01|1
72514372|NCT05027516|144559486|SUPERIORITY||Ratio|1.01||||0.5621|TWO_SIDED|95.0|0.79|1.27|||Permutation testing|||For tetracyclines||1.27|0.79|0.5621
72514373|NCT05027516|144559487|SUPERIORITY|||||||0.196|||||||Wilcoxon (Mann-Whitney)|||For streptococci||||0.196
72514374|NCT05027516|144559487|SUPERIORITY|||||||0.568|||||||Wilcoxon (Mann-Whitney)|||For streptococci||||0.568
72514375|NCT05027516|144559487|SUPERIORITY|||||||0.978|||||||Wilcoxon (Mann-Whitney)|||For Neisseria||||0.978
72514376|NCT05027516|144559487|SUPERIORITY|||||||0.184|||||||Wilcoxon (Mann-Whitney)|||For Neisseria||||0.184
72514377|NCT03655717|144559488|SUPERIORITY||Mean Difference (Final Values)|-0.038|STANDARD_ERROR_OF_MEAN|0.113||0.94|TWO_SIDED|95.0|-0.259|0.184||The p-value is adjusted for multiple comparisons using the Benjamini-Hochberg method across the two primary outcome measures and six contrasts. Effects were deemed significant for p\<0.05.|Regression, Linear|Estimates for p-values were obtained via a non-parametric resampling approach randomly shuffling condition and refitting the data 10,000 times.|Estimate is the mean difference in average HbO level between pre-dose scans and post-dose scans for dronabinol conditions (positive values denote higher HbO levels for post-dronabinol scans).|The mean difference in average HbO levels (converted to z-scores) between the pre and post-dose scans for conditions where a participant was dosed with dronabinol (i.e., a main effect for dronabinol dose), estimated via a linear model with with a subject-varying intercept and covariates for (a) overall differences between pre and post-dose scans and (b) visit order.||0.184|-0.259|0.94
72403065|NCT03336216|144311979|SUPERIORITY||Hazard Ratio (HR)|1.47|||||TWO_SIDED|60.0|1.19|1.82||||||||1.82|1.19|
72403066|NCT03336216|144311979|SUPERIORITY||Hazard Ratio (HR)|1.0|||||TWO_SIDED|60.0|0.77|1.3||||||||1.30|0.77|
72403067|NCT03336216|144311979|SUPERIORITY||Hazard Ratio (HR)|0.78|||||TWO_SIDED|60.0|0.6|1.03||||||||1.03|0.60|
72514378|NCT03655717|144559488|SUPERIORITY||Mean Difference (Final Values)|-0.018|STANDARD_ERROR_OF_MEAN|0.206||0.94|TWO_SIDED|95.0|-0.421|0.386||The p-value is adjusted for multiple comparisons using the Benjamini-Hochberg method across the two primary outcome measures and six contrasts. Effects were deemed significant for p\<0.05.|Regression, Linear|Estimates for p-values were obtained via a non-parametric resampling approach randomly shuffling condition and refitting the data 10,000 times.|Estimate is the mean difference in average HbO level between pre-dose scans and post-dose scans for ethanol conditions (positive values denote higher HbO levels for post-ethanol scans).|The mean difference in average HbO levels (converted to z-scores) between the pre and post-dose scans for conditions where a participant was dosed with ethanol (i.e., a main effect for ethanol dose), estimated via a linear model with with a subject-varying intercept and covariates for (a) overall differences between pre and post-dose scans and (b) visit order.||0.386|-0.421|0.94
72577042|NCT00261443|144680755|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.01||||0.576|TWO_SIDED|95.0|-0.05|0.03||ANOVA model, controlling for treatment and mood stabilizer, is used for baseline. ANCOVA model, controlling for treatment, mood stabilizer, and baseline value, is used for mean change from baseline.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences and p-values are based on the ANOVA/ANCOVA model.||Week 52 LOCF Treatment Difference||0.03|-0.05|0.576
72403068|NCT03336216|144311980|SUPERIORITY||Hazard Ratio (HR)|1.64|||||TWO_SIDED|60.0|1.33|2.02||||||||2.02|1.33|
72487501|NCT00943579|144503575|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||Chi-squared|||Chi-square analyses were used to assess CGI-I scores. there were no transformations.||||>.05
72577043|NCT00261443|144680755|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.02||||0.636|TWO_SIDED|95.0|-0.05|0.08||ANOVA model, controlling for treatment and mood stabilizer, is used for baseline. ANCOVA model, controlling for treatment, mood stabilizer, and baseline value, is used for mean change from baseline.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences and p-values are based on the ANOVA/ANCOVA model.||Highest Value treatment Difference||0.08|-0.05|0.636
72403069|NCT03336216|144311980|SUPERIORITY||Hazard Ratio (HR)|1.13||||||60.0|0.87|1.46||||||||1.46|0.87|
72403070|NCT03336216|144311980|SUPERIORITY||Hazard Ratio (HR)|0.72||||||60.0|0.55|0.94||||||||0.94|0.55|
72403071|NCT03336216|144311983|SUPERIORITY||Strata adjusted difference|1.8||||0.6537||95.0|-5.5|9.0||Stratified CMH test stratified by ECOG and prior chemotherapy|Cochran-Mantel-Haenszel||Based on Cochran-Mantel-Haenszel (CMH) method of weighting|||9.0|-5.5|0.6537
72403072|NCT03336216|144311983|SUPERIORITY||Strata adjusted difference|12.5||||0.0951||95.0|3.1|21.9||Stratified CMH test stratified by ECOG and prior chemotherapy|Cochran-Mantel-Haenszel||Based on Cochran-Mantel-Haenszel (CMH) method of weighting|||21.9|3.1|0.0951
72487502|NCT00683163|144503584|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.2||||0.82|TWO_SIDED|95.0|-11.5|9.2|||t-test, 2 sided|||Mean difference in percent change from baseline (Concurrent - Sequential)||9.2|-11.5|0.82
72487503|NCT00449670|144503597|EQUIVALENCE|The lot-to-lot consistency 21 days after Dose 2 was demonstrated if, for all pairs of lots, the two-sided 95% CIs for the ratio of A/Vietnam/1194/2004 HI antibody GMT was within the \[0.5 ; 2\] clinical limit interval.|Adjusted GMT ratio|0.81||||||95.0|0.66|1.01|||ANCOVA|||Demonstration of the consistency of the immune response (in terms of geometric mean titer \[GMT\] ratio for anti-hemagglutinin (anti-HA) antibody response against the A/Vietnam/1194/2004 strain 21 days after the second vaccination) elicited by two compositions of H5N1 adjuvanted vaccine (Lot 1 and Lot 2).||1.01|0.66|
72487504|NCT00449670|144503597|EQUIVALENCE|The lot-to-lot consistency 21 days after Dose 2 was demonstrated if, for all pairs of lots, the two-sided 95% CIs for the ratio of A/Vietnam/1194/2004 HI antibody GMT was within the \[0.5 ; 2\] clinical limit interval.|Adjusted GMT ratio|0.85|||||TWO_SIDED|95.0|0.69|1.06|||ANCOVA|||Demonstration of the consistency of the immune response (in terms of geometric mean titer \[GMT\] ratio for anti-hemagglutinin (anti-HA) antibody response against the A/Vietnam/1194/2004 strain 21 days after the second vaccination) elicited by two compositions of H5N1 adjuvanted vaccine (Lot 1 and Lot 3).||1.06|0.69|
72487505|NCT00449670|144503597|EQUIVALENCE|The lot-to-lot consistency 21 days after Dose 2 was demonstrated if, for all pairs of lots, the two-sided 95% CIs for the ratio of A/Vietnam/1194/2004 HI antibody GMT was within the \[0.5 ; 2\] clinical limit interval.|Adjusted GMT ratio|0.85|||||TWO_SIDED|95.0|0.68|1.05|||ANCOVA|||Demonstration of the consistency of the immune response (in terms of geometric mean titer \[GMT\] ratio for anti-hemagglutinin (anti-HA) antibody response against the A/Vietnam/1194/2004 strain 21 days after the second vaccination) elicited by two compositions of H5N1 adjuvanted vaccine (Lot 1 and Lot 4).||1.05|0.68|
72487506|NCT00449670|144503597|EQUIVALENCE|The lot-to-lot consistency 21 days after Dose 2 was demonstrated if, for all pairs of lots, the two-sided 95% CIs for the ratio of A/Vietnam/1194/2004 HI antibody GMT was within the \[0.5 ; 2\] clinical limit interval.|Adjusted GMT ratio|1.05|||||TWO_SIDED|95.0|0.85|1.3|||ANCOVA|||Demonstration of the consistency of the immune response (in terms of geometric mean titer \[GMT\] ratio for anti-hemagglutinin (anti-HA) antibody response against the A/Vietnam/1194/2004 strain 21 days after the second vaccination) elicited by two compositions of H5N1 adjuvanted vaccine (Lot 2 and Lot 3).||1.3|0.85|
72487507|NCT00449670|144503597|EQUIVALENCE|The lot-to-lot consistency 21 days after Dose 2 was demonstrated if, for all pairs of lots, the two-sided 95% CIs for the ratio of A/Vietnam/1194/2004 HI antibody GMT was within the \[0.5 ; 2\] clinical limit interval.|Adjusted GMT ratio|1.04|||||TWO_SIDED|95.0|0.84|1.29|||ANCOVA|||Demonstration of the consistency of the immune response (in terms of geometric mean titer \[GMT\] ratio for anti-hemagglutinin (anti-HA) antibody response against the A/Vietnam/1194/2004 strain 21 days after the second vaccination) elicited by two compositions of H5N1 adjuvanted vaccine (Lot 2 and Lot 4).||1.29|0.84|
72487508|NCT00449670|144503597|EQUIVALENCE|The lot-to-lot consistency 21 days after Dose 2 was demonstrated if, for all pairs of lots, the two-sided 95% CIs for the ratio of A/Vietnam/1194/2004 HI antibody GMT was within the \[0.5 ; 2\] clinical limit interval.|Adjusted GMT ratio|0.99|||||TWO_SIDED|95.0|0.8|1.23|||ANCOVA|||Demonstration of the consistency of the immune response (in terms of geometric mean titer \[GMT\] ratio for anti-hemagglutinin (anti-HA) antibody response against the A/Vietnam/1194/2004 strain 21 days after the second vaccination) elicited by two compositions of H5N1 adjuvanted vaccine (Lot 3 and Lot 4).||1.23|0.8|
72487509|NCT01251653|144503660|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside interval 80% to 125%|Ratio of adjusted gmeans in percentage|81.27|STANDARD_DEVIATION|63.3||0.4815|TWO_SIDED|90.0|44.863|147.205|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of Afatinib with Gemcitabine vs. Afatinib without Gemcitabine was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually intra-individual geometric coefficient variation (gCV).|||147.205|44.863|0.4815
72487510|NCT01251653|144503660|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside interval 80% to 125%|Ratio of adjusted gmeans in percentage|95.36|STANDARD_DEVIATION|15.4||0.0149|TWO_SIDED|90.0|84.139|108.077|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of Afatinib with Docetaxel vs. Afatinib without Docetaxel was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually intra-individual geometric coefficient variation (gCV).|||108.077|84.139|0.0149
72487511|NCT01251653|144503660|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside interval 80% to 125%|Ratio of adjusted gmeans in percentage|88.12|STANDARD_DEVIATION|9.2||0.0208|TWO_SIDED|90.0|81.778|94.964|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of Afatinib with Docetaxel vs. Afatinib without Docetaxel was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually intra-individual geometric coefficient variation (gCV).|||94.964|81.778|0.0208
72403073|NCT03336216|144311983|SUPERIORITY||Strata adjusted difference|5.0||||0.5171||95.0|-8.0|18.1||Stratified CMH test stratified by ECOG and prior chemotherapy|Cochran-Mantel-Haenszel||Based on Cochran-Mantel-Haenszel (CMH) method of weighting|||18.1|-8.0|0.5171
72403074|NCT03336216|144311984|SUPERIORITY||Strata adjusted difference|-0.8||||0.8505|TWO_SIDED|95.0|-9.4|7.7||Stratified CMH test stratified by ECOG and prior chemotherapy|Cochran-Mantel-Haenszel||Based on Cochran-Mantel-Haenszel (CMH) method of weighting|||7.7|-9.4|0.8505
72403075|NCT03336216|144311984|SUPERIORITY||Strata adjusted difference|1.5||||0.8144|TWO_SIDED|95.0|-9.9|12.8||Stratified CMH test stratified by ECOG and prior chemotherapy|Cochran-Mantel-Haenszel||Based on Cochran-Mantel-Haenszel (CMH) method of weighting|||12.8|-9.9|0.8144
72403076|NCT03336216|144311984|SUPERIORITY||Strata adjusted difference|0.7||||0.9087|TWO_SIDED|95.0|-10.7|12.1||Stratified CMH test stratified by ECOG and prior chemotherapy.|Cochran-Mantel-Haenszel||Based on Cochran-Mantel-Haenszel (CMH) method of weighting|||12.1|-10.7|0.9087
72403077|NCT03336216|144311987|SUPERIORITY||Cox Proportional Hazard|1.22|||||TWO_SIDED|95.0|0.76|1.96|||||Stratified Cox proportional hazard model by ECOG and type of prior chemotherapy|||1.96|0.76|
72403078|NCT03336216|144311987|SUPERIORITY||Cox Proportional Hazard|1.04|||||TWO_SIDED|95.0|0.59|1.86|||||Stratified Cox proportional hazard model by ECOG and type of prior chemotherapy|||1.86|0.59|
72487512|NCT01251653|144503661|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside interval 80% to 125%|Ratio of adjusted gmeans in percentage|141.36|STANDARD_DEVIATION|14.7||0.8715|TWO_SIDED|90.0|115.848|172.495|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of Afatinib with Gemcitabine vs. Afatinib without Gemcitabine was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually intra-individual geometric coefficient variation (gCV).|||172.495|115.848|0.8715
72487513|NCT01251653|144503661|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside interval 80% to 125%|Ratio of adjusted gmeans in percentage|77.42|STANDARD_DEVIATION|16.8||0.6805|TWO_SIDED|90.0|68.516|87.473|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of Afatinib with Docetaxel vs. Afatinib without Docetaxel was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually intra-individual geometric coefficient variation (gCV).|||87.473|68.516|0.6805
72487514|NCT01251653|144503661|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside interval 80% to 125%|Ratio of adjusted gmeans in percentage|83.95|STANDARD_DEVIATION|14.3||0.2327|TWO_SIDED|90.0|74.794|94.217|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of Afatinib with Docetaxel vs. Afatinib without Docetaxel was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually intra-individual geometric coefficient variation (gCV).|||94.217|74.794|0.2327
72514379|NCT03655717|144559488|SUPERIORITY||Mean Difference (Final Values)|0.016|STANDARD_ERROR_OF_MEAN|0.281||0.94|TWO_SIDED|95.0|-0.535|0.568||The p-value is adjusted for multiple comparisons using the Benjamini-Hochberg method across the two primary outcome measures and six contrasts. Effects were deemed significant for p\<0.05.|Regression, Linear|Estimates for p-values were obtained via a non-parametric resampling approach randomly shuffling condition and refitting the data 10,000 times.|Estimate is the mean difference in average HbO level between pre-dose scans and post-dose scans for the dronabinol + ethanol condition (positive values denote higher HbO levels for post-dronabinol+ethanol scans).|The mean difference in average HbO levels (converted to z-scores) between the pre and post-dose scans for conditions where a participant was dosed with both dronabinol and ethanol (i.e., the interaction between dronabinol and ethanol doses), estimated via a linear model with with a subject-varying intercept and covariates for (a) overall differences between pre and post-dose scans and (b) visit order.||0.568|-0.535|0.94
72403079|NCT03336216|144311987|SUPERIORITY||Cox Proportional Hazard|0.81|||||TWO_SIDED|95.0|0.45|1.46|||||Stratified Cox proportional hazard model by ECOG and type of prior chemotherapy|||1.46|0.45|
72403080|NCT03090100|144312030|NON_INFERIORITY|Non-inferiority margin of 10%|Difference in percentage|14.2|||<|0.001|TWO_SIDED|95.0|9.2|19.2|||z-test|||||19.2|9.2|<0.001
72403081|NCT03090100|144312030|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
72487515|NCT01251653|144503662|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside interval 80% to 125%|Ratio of adjusted gmeans in percentage|136.11|STANDARD_DEVIATION|26.3||0.7759|TWO_SIDED|90.0|112.09|165.29|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of Gemcitabine with Afatinib vs. Gemcitabine without Afatinib was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually intra-individual geometric coefficient variation (gCV).|||165.29|112.09|0.7759
72487516|NCT01251653|144503663|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside interval 80% to 125%|Ratio of adjusted gmeans in percentage|118.41|STANDARD_DEVIATION|31.6||0.3359|TWO_SIDED|90.0|94.81|147.88|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of Gemcitabine with Afatinib vs. Gemcitabine without Afatinib was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually intra-individual geometric coefficient variation (gCV).|||147.88|94.81|0.3359
72403082|NCT03090100|144312031|NON_INFERIORITY|Non-inferiority margin of 10%|Difference in percentage|4.3|||<|0.001|TWO_SIDED|95.0|-0.2|8.9|||z-test|||||8.9|-0.2|<0.001
72403083|NCT03090100|144312031|SUPERIORITY|||||||0.062|||||||Cochran-Mantel-Haenszel|||||||0.062
72403084|NCT03090100|144312032|OTHER||Difference in percentage|-7.0|||||TWO_SIDED|95.0|-12.2|-1.7||||||||-1.7|-12.2|
72403085|NCT03090100|144312033|OTHER||Difference in percentage|-2.3|||||TWO_SIDED|95.0|-6.0|1.2||||||||1.2|-6.0|
72403086|NCT03090100|144312034|OTHER||Difference in percentage|9.7|||||TWO_SIDED|95.0|3.8|15.5||||||||15.5|3.8|
72403087|NCT03090100|144312035|OTHER||Difference in percentage|11.6|||||TWO_SIDED|95.0|5.8|17.4||||||||17.4|5.8|
72403088|NCT03090100|144312036|OTHER||Difference in percentage|9.7|||||TWO_SIDED|95.0|4.9|14.5||||||||14.5|4.9|
72567980|NCT02037165|144667471|SUPERIORITY_OR_OTHER||adjusted mean difference|0.24|STANDARD_ERROR_OF_MEAN|1.1755|||TWO_SIDED|95.0|-2.1|2.5|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 22:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||2.5|-2.1|
72403089|NCT03090100|144312037|OTHER||Difference in percentage|7.8|||||TWO_SIDED|95.0|2.3|13.2||||||||13.2|2.3|
72403090|NCT03090100|144312038|OTHER||Difference in percentage|-0.3|||||TWO_SIDED|95.0|-3.5|3.1||||||||3.1|-3.5|
72403091|NCT03090100|144312039|OTHER||Difference in percentage|-1.4|||||TWO_SIDED|95.0|-6.2|3.4||||||||3.4|-6.2|
72403092|NCT03090100|144312040|OTHER||Difference in percentage|9.8|||||TWO_SIDED|95.0|4.2|15.3||||||||15.3|4.2|
72403093|NCT03090100|144312041|OTHER||Difference in percentage|-0.1|||||TWO_SIDED|95.0|-4.2|3.9||||||||3.9|-4.2|
72403094|NCT03090100|144312042|OTHER||Difference in percentage|-0.9|||||TWO_SIDED|95.0|-5.0|3.3||||||||3.3|-5.0|
72403095|NCT00952341|144312053|SUPERIORITY_OR_OTHER|||||||0.007||95.0|||||Regression, Logistic|||"Adjusted by gender and concomitant~chemotherapy.~The apriori significance level was set at 0.05.~There was no adjustment for multiplicity."||||0.007
72403096|NCT00952341|144312054|SUPERIORITY_OR_OTHER|||||||0.942||95.0|||||Regression, Logistic|||"Adjusted by gender and concomitant chemotherapy.~The apriori significance level was set at 0.05.~There was no adjustment for multiplicity."||||0.942
72487517|NCT01251653|144503666|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside interval 80% to 125%|Ratio of adjusted gmeans in percentage|93.69|STANDARD_DEVIATION|19.5||0.0349|TWO_SIDED|90.0|81.352|107.89|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of Docetaxel with Afatinib vs. Docetaxel without Afatinib was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually intra-individual geometric coefficient variation (gCV).|||107.890|81.352|0.0349
72487518|NCT01251653|144503666|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside interval 80% to 125%|Ratio of adjusted gmeans in percentage|98.11|STANDARD_DEVIATION|30.4||0.0405|TWO_SIDED|90.0|81.053|118.76|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of Docetaxel with Afatinib vs. Docetaxel without Afatinib was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually intra-individual geometric coefficient variation (gCV).|||118.760|81.053|0.0405
72577044|NCT00261443|144680756|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.01||||0.774|TWO_SIDED|95.0|-0.06|0.08||ANOVA model, controlling for treatment and mood stabilizer, is used for baseline. ANCOVA model, controlling for treatment, mood stabilizer, and baseline value, is used for mean change from baseline.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences and p-values are based on the ANOVA/ANCOVA model.||Week 52 LOCF Treatment Difference||0.08|-0.06|0.774
72403097|NCT00952341|144312055|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||Regression, Logistic|||"Adjusted by gender and concomitant chemotherapy.~The apriori significance level was set at 0.05.~There was no adjustment for multiplicity."||||0.001
72403098|NCT00952341|144312056|SUPERIORITY_OR_OTHER|||||||0.003||95.0|||||Regression, Logistic|||"Adjusted by gender and concomitant~chemotherapy."||||0.003
72403099|NCT00952341|144312057|SUPERIORITY_OR_OTHER|||||||0.882||95.0|||||Regression, Logistic|||Adjusted by gender and concomitant chemotherapy.||||0.882
72403100|NCT00952341|144312058|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||Regression, Logistic|||Adjusted by gender and concomitant chemotherapy.||||0.001
72403101|NCT03760796|144312067|OTHER||Hazard Ratio (HR)|0.48||||0.018|TWO_SIDED|95.0|0.26|0.88||The a priori threshold for statistical significance was \<0.05.|Regression, Cox|Adjusting for hospital site and a propensity score inclusive of individual level baseline characteristics.||||0.88|0.26|0.018
72403102|NCT03760796|144312068|OTHER|A Markov Model of cost-effectiveness, based on 30-day readmission rates, was built to assess the Incremental Cost-Effectiveness Ratio (ICER) of adopting the Corrie Platform compared to standard of care for post AMI patients; taking into account the estimated cost of Corrie ($2,750 per patient for a 1-year use term). The reported value is a ratio of the relative cost of intervention compared to the standard of care divided by the change in the outcome, quality-adjusted life years (QALYs).|Incremental Cost-Effectiveness Ratio|-7.0|||||TWO_SIDED||||||||A negative ICER means the intervention cost is lower than the cost of standard of care, while the denominator was positive. A positive ICER means the intervention cost is greater than the cost of standard of care, while the denominator was positive.|||||
72403103|NCT03760796|144312082|OTHER||Hazard Ratio (HR)|1.45||||0.33|TWO_SIDED|95.0|0.69|2.98||The a priori threshold for statistical significance was \<0.05.|Regression, Cox|Adjusting for hospital site and a propensity score inclusive of individual level baseline characteristics.||||2.98|0.69|0.33
72403104|NCT01589445|144312107|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-9.06|STANDARD_DEVIATION|39.47|<|0.161||95.0|-88.0|118.0||Category: Univariate \& Multivariate analysis. (ANOVA, Pair t tests, MLR, OR, Pearson Correlation)|ANOVA|||TC||118|-88.0|<0.161
72403105|NCT01589445|144312107|SUPERIORITY_OR_OTHER||Mean Difference (Net)|10.66|STANDARD_DEVIATION|143.22|<|0.913|TWO_SIDED|95.0|-397.0|976.0||Category: Univariate \& Multivariate analysis. (ANOVA, Pair t tests, MLR, OR, Pearson Correlation)|ANOVA|||TG||976|-397.0|<0.913
72403106|NCT01589445|144312107|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.47|STANDARD_DEVIATION|9.59|<|0.322|TWO_SIDED|95.0|-35.0|19.0||Category: Univariate \& Multivariate analysis. (ANOVA, Pair t tests, MLR, OR, Pearson Correlation)|ANOVA|||HDL||19.0|-35.0|<0.322
72403107|NCT01589445|144312107|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-10.62|STANDARD_DEVIATION|32.05|<|0.21|TWO_SIDED|95.0|-113.8|76.2||Category: Univariate \& Multivariate analysis. (ANOVA, Pair t tests, MLR, OR, Pearson Correlation)|ANOVA|||LDL||76.2|-113.8|<0.210
72514380|NCT03655717|144559489|SUPERIORITY||Mean Difference (Final Values)|-0.163|STANDARD_ERROR_OF_MEAN|0.113||0.94|TWO_SIDED|95.0|-0.384|0.057||The p-value is adjusted for multiple comparisons using the Benjamini-Hochberg method across the two primary outcome measures and six contrasts. Effects were deemed significant for p\<0.05.|Regression, Linear|Estimates for p-values were obtained via a non-parametric resampling approach randomly shuffling condition and refitting the data 10,000 times.|Estimate is the mean difference in average HbO level between pre-dose scans and post-dose scans for dronabinol conditions (positive values denote higher HbO levels for post-dronabinol scans).|The mean difference in average HbO levels (converted to z-scores) between the pre and post-dose scans for conditions where a participant was dosed with dronabinol (i.e., a main effect for dronabinol dose), estimated via a linear model with with a subject-varying intercept and covariates for (a) overall differences between pre and post-dose scans and (b) visit order.||0.057|-0.384|0.94
72514381|NCT03655717|144559489|SUPERIORITY||Mean Difference (Final Values)|-0.176|STANDARD_ERROR_OF_MEAN|0.21||0.94|TWO_SIDED|95.0|-0.588|0.237||The p-value is adjusted for multiple comparisons using the Benjamini-Hochberg method across the two primary outcome measures and six contrasts. Effects were deemed significant for p\<0.05.|Regression, Linear|Estimates for p-values were obtained via a non-parametric resampling approach randomly shuffling condition and refitting the data 10,000 times.|Estimate is the mean difference in average HbO level between pre-dose scans and post-dose scans for ethanol conditions (positive values denote higher HbO levels for post-ethanol scans).|The mean difference in average HbO levels (converted to z-scores) between the pre and post-dose scans for conditions where a participant was dosed with ethanol (i.e., a main effect for ethanol dose), estimated via a linear model with with a subject-varying intercept and covariates for (a) overall differences between pre and post-dose scans and (b) visit order.||0.237|-0.588|0.94
72514382|NCT03655717|144559489|SUPERIORITY||Mean Difference (Final Values)|0.187|STANDARD_ERROR_OF_MEAN|0.276||0.94|TWO_SIDED|95.0|-0.354|0.728||The p-value is adjusted for multiple comparisons using the Benjamini-Hochberg method across the two primary outcome measures and six contrasts. Effects were deemed significant for p\<0.05.|Regression, Linear|Estimates for p-values were obtained via a non-parametric resampling approach randomly shuffling condition and refitting the data 10,000 times.|Estimate is the mean difference in average HbO level between pre-dose scans and post-dose scans for the dronabinol + ethanol condition (positive values denote higher HbO levels for post-dronabinol+ethanol scans).|The mean difference in average HbO levels (converted to z-scores) between the pre and post-dose scans for conditions where a participant was dosed with both dronabinol and ethanol (i.e., the interaction between dronabinol and ethanol doses), estimated via a linear model with with a subject-varying intercept and covariates for (a) overall differences between pre and post-dose scans and (b) visit order.||0.728|-0.354|0.94
72514383|NCT00961662|144559495|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.5|STANDARD_DEVIATION|1.0|<|0.05|TWO_SIDED|95.0|||||ANCOVA|||The HbA1c percent change at each study visit was calculated and then categorized as a binary response (i.e., responders and non-responders) for each subject based on the breakpoint to be used in the endpoint. Inferential statistics were prepared to compare the differences across the three treatments a using logistic regression model with the dose group and the HbA1c stratum included in the mode||||<0.05
72514384|NCT05137730|144559574|OTHER||Ratio of geometric least squares means|0.78|||||TWO_SIDED|90.0|0.7109|0.8611|||||Least squares means (LSMs) were calculated by exponentiating the LSMs derived from the linear mixed effects model.|||0.8611|0.7109|
72514385|NCT05137730|144559575|OTHER||Dose effect|1.5395|STANDARD_ERROR_OF_MEAN|0.121|||TWO_SIDED|95.0|1.2929|1.7862||||||A linear regression model was used, including sequence and period as fixed effects, subject within sequence as a random effect, and ln(dose) as a covariate.||1.7862|1.2929|
72514386|NCT05137730|144559576|OTHER||Ratio of geometric least squares means|0.84|||||TWO_SIDED|90.0|0.7576|0.9375|||||LSMs were calculated by exponentiating the LSMs derived from the linear mixed effects model.|||0.9375|0.7576|
72514387|NCT05137730|144559577|OTHER||Dose effect|1.2823|STANDARD_ERROR_OF_MEAN|0.1072|||TWO_SIDED|95.0|1.0431|1.5215||||||A linear regression model using was used, including sequence and period as fixed effects, subject within sequence as a random effect, and ln(dose) as a covariate.||1.5215|1.0431|
72514388|NCT05137730|144559578|OTHER||Ratio of geometric least squares means|0.81|||||TWO_SIDED|90.0|0.7462|0.8893|||||LSMs were calculated by exponentiating the LSMs derived from the linear mixed effects model.|||0.8893|0.7462|
72567981|NCT02037165|144667471|SUPERIORITY_OR_OTHER||adjusted mean difference|0.43|STANDARD_ERROR_OF_MEAN|1.1758|||TWO_SIDED|95.0|-1.9|2.7|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 24:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||2.7|-1.9|
72487519|NCT01251653|144503667|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside interval 80% to 125%|Ratio of adjusted gmeans in percentage|90.78|STANDARD_DEVIATION|22.8||0.0728|TWO_SIDED|90.0|78.566|104.901|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of Docetaxel with Afatinib vs. Docetaxel without Afatinib was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually intra-individual geometric coefficient variation (gCV).|||104.901|78.566|0.0728
72487520|NCT01251653|144503667|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside interval 80% to 125%|Ratio of adjusted gmeans in percentage|85.74|STANDARD_DEVIATION|48.9||0.3294|TWO_SIDED|90.0|65.561|112.138|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of Docetaxel with Afatinib vs. Docetaxel without Afatinib was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually intra-individual geometric coefficient variation (gCV).|||112.138|65.561|0.3294
72487521|NCT01798589|144503670|OTHER|Bioequivalence is assessed based on concordance between the 2 allergen using Kappa statistic|Concordance|66.7|||||TWO_SIDED|95.0|41.6|90.2||||||||90.2|41.6|
72514389|NCT05137730|144559579|OTHER||Dose effect|1.0937|STANDARD_ERROR_OF_MEAN|0.0763|||TWO_SIDED|95.0|0.938|1.2493||||||A linear regression model was used, including sequence and period as fixed effects, subject within sequence as a random effect, and ln(dose) as a covariate.||1.2493|0.9380|
72567982|NCT02037165|144667471|SUPERIORITY_OR_OTHER||adjusted mean difference|-1.68|STANDARD_ERROR_OF_MEAN|1.1567|||TWO_SIDED|95.0|-4.0|0.6|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 0:30h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||0.6|-4.0|
72403108|NCT01589445|144312108|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.74|STANDARD_DEVIATION|2.41|<|0.05|TWO_SIDED|95.0|-7.9|8.0||Category: Univariate \& Multivariate analysis. (ANOVA, Pair t tests, Multiple Logistic Regression (MLR), OR, Pearson Correlation)|ANOVA||The group 001 was divided according to Pro12Pro and Pro12Ala groups.There was no Ala12Ala group.These two groups were compared also in accordance with all parameters (glycemic levels, insulin levels, lipid profiles, BMI).|Change from Baseline in FSG at 3rd month||8.0|-7.9|<0.05
72403109|NCT01589445|144312109|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.64|STANDARD_DEVIATION|1.07|>|0.05|TWO_SIDED|95.0|-4.4|2.4||Category: Univariate \& Multivariate analysis. (ANOVA, Pair t tests, MLR, OR, Pearson Correlation)|ANOVA|||||2.4|-4.4|>0.05
72403110|NCT01589445|144312110|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.02|STANDARD_DEVIATION|0.12|<|0.001|TWO_SIDED|95.0|-0.4|0.27||Category: Univariate \& Multivariate analysis. (ANOVA, Pair t tests, MLR, OR, Pearson Correlation)|ANOVA|||||0.27|-0.40|<0.001
72403111|NCT01589445|144312110|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.04|STANDARD_DEVIATION|4.25|<|0.004|TWO_SIDED|95.0|-14.12|15.52||Category: Univariate \& Multivariate analysis. (ANOVA, Pair t tests, MLR, OR, Pearson Correlation)|ANOVA|||HOMA IR||15.52|-14.12|<0.004
72577045|NCT00261443|144680756|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|0.04||||0.444|TWO_SIDED|95.0|-0.06|0.14||ANOVA model, controlling for treatment and mood stabilizer, is used for baseline. ANCOVA model, controlling for treatment, mood stabilizer, and baseline value, is used for mean change from baseline.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences and p-values are based on the ANOVA/ANCOVA model.||Highest Value of Change, Treatment Difference||0.14|-0.06|0.444
72577046|NCT01371747|144680801|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||P-value \<0.001|ANCOVA|||Each starting dose group was compared to its baseline.||||<0.001
72403112|NCT01589445|144312111|SUPERIORITY_OR_OTHER||Mean Difference (Net)|9.79|STANDARD_DEVIATION|84.46|<|0.808|TWO_SIDED|95.0|-346.4|328.1||Category: Univariate \& Multivariate analysis. (ANOVA, Pair t tests, MLR, OR, Pearson Correlation)|ANOVA|||HOMA B||328.10|-346.40|<0.808
72403113|NCT01589445|144312111|SUPERIORITY_OR_OTHER||Mean Difference (Net)|7.53|STANDARD_DEVIATION|54.0|<|0.025|TWO_SIDED|95.0|-148.7|180.0||Category: Univariate \& Multivariate analysis. (ANOVA, Pair t tests, MLR, OR, Pearson Correlation)|ANOVA|||HOMA S||180|-148.70|<0.025
72403114|NCT01589445|144312112|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.09|STANDARD_DEVIATION|10.2|<|0.039|TWO_SIDED|95.0|-27.04|26.52||Category: Univariate \& Multivariate analysis. (ANOVA, Pair t tests, MLR, OR, Pearson Correlation)|ANOVA|||FSI||26.52|-27.04|<0.039
72403115|NCT01334723|144312123|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.38||||||95.0|0.35|0.412|||||A time-to-event analysis was used to evaluate the likelihood of AUR or prostate surgery.|||0.412|0.350|
72514390|NCT03341923|144559598|NON_INFERIORITY|"Difference (DT1MF-AMMF) of percentage of subjects rated as Optimal was provided with two-sided 95% confidence interval (CI). If lower limit of CI was above -10% as non-inferiority criteria, non-inferiority was to be demonstrated."|Difference in proportion|6.1||||0.0455|TWO_SIDED|95.0|0.2|11.9|||McNemar|||||11.9|0.2|0.0455
72514391|NCT03341923|144559598|SUPERIORITY|After demonstrating noninferiority, if lower limit of CI was above 0% as superiority criteria, superiority was to be demonstrated.|Difference in proportion|6.1||||0.0455|TWO_SIDED|95.0|0.2|11.9|||McNemar|||||11.9|0.2|0.0455
72403116|NCT01334723|144312123|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.294||||||95.0|0.235|0.368|||||A time-to-event analysis was used to evaluate the likelihood of AUR or prostate surgery.|||0.368|0.235|
72403117|NCT01334723|144312124|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.613||||||95.0|0.562|0.668|||||A time-to-event analysis was used to evaluate the likelihood of AUR or prostate surgery.|||0.668|0.562|
72403118|NCT01334723|144312124|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.542||||||95.0|0.427|0.689|||||A time-to-event analysis was used to evaluate the likelihood of AUR or prostate surgery.|||0.689|0.427|
72403119|NCT01334723|144312125|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.519||||||95.0|0.472|0.57|||||A time-to-event analysis was used to evaluate the likelihood of AUR or prostate surgery.|||0.570|0.472|
72403120|NCT01334723|144312125|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.436||||||95.0|0.333|0.57|||||A time-to-event analysis was used to evaluate the likelihood of AUR or prostate surgery.|||0.570|0.333|
72403121|NCT01817725|144312131|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
72403122|NCT02439320|144312188|SUPERIORITY||Odds Ratio (OR)|2.2|||<|0.001|TWO_SIDED|95.0|1.6|3.0|||Regression, Logistic|||||3.0|1.6|<0.001
72487522|NCT02232802|144503676|EQUIVALENCE|Following logarithmic transformation, Cmax values were subjected to an analysis of variance (ANOVA), including fixed effects for sequence, period, treatment and subject nested within sequence.|least square mean difference ratio|99.42|||||TWO_SIDED|95.0|96.28|102.65|||||Geometric least square means are being compared.|Statistical comparison for Anti-FXa||102.65|96.28|
72487523|NCT02232802|144503676|EQUIVALENCE|Following logarithmic transformation, Cmax was subjected to an analysis of variance (ANOVA), including fixed effects for sequence, period, treatment and subject nested within sequence|least square mean difference ratio|91.55|||||TWO_SIDED|95.0|86.65|96.73|||||Geometric least square means are being compared.|Statistical comparison on Anti-FIIa||96.73|86.65|
72487524|NCT02232802|144503677|EQUIVALENCE|Following logarithmic transformation, AUC0-t values were subjected to an analysis of variance (ANOVA), including fixed effects for sequence, period, treatment and subject nested within sequence|least square mean difference ratio|102.89|||||TWO_SIDED|95.0|100.67|105.15|||||Geometric least square means are being compared.|Anti-FXa statistical comparison||105.15|100.67|
72487525|NCT02232802|144503677|EQUIVALENCE|Following logarithmic transformation, AUC0-t values were subjected to an analysis of variance (ANOVA), including fixed effects for sequence, period, treatment and subject nested within sequence.|least square mean difference ratio|92.37|||||TWO_SIDED|95.0|87.72|97.25|||||Geometric least square means are being compared.|Anti-FIIa comparison||97.25|87.72|
72487526|NCT02232802|144503678|EQUIVALENCE|Following logarithmic transformation, AUC0-inf values were subjected to an analysis of variance (ANOVA), including fixed effects for sequence, period, treatment and subject nested within sequence|least square mean ratio|104.26|||||TWO_SIDED|95.0|101.68|106.9|||||Geometric least square means are being compared.|Anti-FXA comparison||106.9|101.68|
72487527|NCT02232802|144503678|EQUIVALENCE|Following logarithmic transformation, AUC0-inf values were subjected to an analysis of variance (ANOVA), including fixed effects for sequence, period, treatment and subject nested within sequence|least square mean ratio|90.44|||||TWO_SIDED|95.0|85.38|95.8|||||Geometric least square means are being compared.|Anti-FIIa comparison||95.8|85.38|
72487528|NCT02232802|144503679|EQUIVALENCE|An assessment of tmax was performed using the Wilcoxon matched pairs test. In addition, a 95 % non-parametric CI was constructed for the median difference in tmax based on the method of Campbell and Gardner.|least square mean ratio|0.0||||0.7642|TWO_SIDED|95.0|-0.5|0.5||An assessment of tmax was performed using the Wilcoxon matched pairs test. In addition, a 95 % non-parametric CI was constructed for the median difference in tmax based on the method of Campbell and Gardner.|Wilcoxon (Mann-Whitney)||Geometric least square means are being compared.|Anti-FXa comparison||0.5|-0.5|0.7642
72487529|NCT02232802|144503679|EQUIVALENCE|An assessment of tmax was performed using the Wilcoxon matched pairs test. In addition, a 95 % non-parametric CI was constructed for the median difference in tmax based on the method of Campbell and Gardner.|least square mean ratio|0.0||||0.9464|TWO_SIDED|95.0|-0.5|0.5|||Wilcoxon (Mann-Whitney)||Geometric least square means are being compared.|Anti-FIIa comparison||0.5|-0.5|0.9464
72487530|NCT02232802|144503685|EQUIVALENCE|Results obtained using a fixed effects ANOVA with fixed effects for sequence, period, treatment and subject nested within sequence|Geometric least square mean ratio|103.94|||||TWO_SIDED|95.0|101.22|106.73||||||||106.73|101.22|
72514392|NCT00077610|144559614|NON_INFERIORITY_OR_EQUIVALENCE|The two RO0503821 dosing schedules were compared separately to epoetin reference using ANCOVA, with Hb at BL and region as the covariates. The test for non-inferiority was based on the lower limit of the two-sided 97.5% confidence interval for the difference between the two groups. When the lower limit was greater than or equal to -0.75 g/dL, the RO0503821 groups were regarded as non-inferior to the epoetin reference group. The confidence level of 97.5% was chosen to adjust for multiplicity.|Mean Difference between groups|0.004|STANDARD_ERROR_OF_MEAN|0.0973|<|0.0001|TWO_SIDED|97.5|-0.215|0.223|||ANCOVA, CI for difference between groups||Difference between groups based on the adjusted means derived from the ANCOVA model|The non-inferiority test for treatment differences in Hb change from baseline, based on analysis of co-variance (ANCOVA) analysis with a non-inferiority limit of -0.75 g/dL.||0.223|-0.215|<0.0001
72514393|NCT00077610|144559614|NON_INFERIORITY_OR_EQUIVALENCE|The two RO0503821 dosing schedules were compared separately to epoetin reference using ANCOVA, with Hb at BL and region as the covariates. The test for non-inferiority was based on the lower limit of the two-sided 97.5% confidence interval for the difference between the two groups. When the lower limit was greater than or equal to -0.3 g/dL, the RO0503821 groups were regarded as non-inferior to the epoetin reference group. The confidence level of 97.5% was chosen to adjust for multiplicity.|Mean Difference between groups|0.051|STANDARD_ERROR_OF_MEAN|0.0997|<|0.0001|TWO_SIDED|97.5|-0.173|0.275|||ANCOVA, CI for difference between groups||Difference between groups based on the adjusted means derived from the ANCOVA model|The non-inferiority test for treatment differences in Hb change from baseline, based on ANCOVA analysis with a non-inferiority limit of -0.75 g/dL.||0.275|-0.173|<0.0001
72514394|NCT00304915|144559625|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.5||||0.003|TWO_SIDED|95.0|1.37|4.56|||Regression, Logistic|||||4.56|1.37|0.003
72403123|NCT02439320|144312188|SUPERIORITY||Odds Ratio (OR)|2.6|||<|0.001|TWO_SIDED|95.0|2.0|3.6|||Regression, Logistic|||||3.6|2.0|<0.001
72403124|NCT02439320|144312189|SUPERIORITY||Odds Ratio (OR)|1.7|||<|0.001|TWO_SIDED|95.0|1.3|2.2|||Regression, Logistic|||||2.2|1.3|<0.001
72487531|NCT02232802|144503686|EQUIVALENCE|Results obtained using a fixed effects ANOVA with fixed effects for sequence, period, treatment and subject nested within sequence.|Geometric least square mean ratio|108.59|||||TWO_SIDED|95.0|103.93|113.46||||||||113.46|103.93|
72487532|NCT02232802|144503687|EQUIVALENCE|Results obtained using a fixed effects ANOVA with fixed effects for sequence, period, treatment and subject nested within sequence.|Geometric least square mean ratio|102.76|||||TWO_SIDED|95.0|97.51|108.28||||||||108.28|97.51|
72487533|NCT02232802|144503688|EQUIVALENCE|Results obtained using a fixed effects ANOVA with fixed effects for sequence, period, treatment and subject nested within sequence|Geometric least square mean ratio|114.91|||||TWO_SIDED|95.0|102.29|129.08||||||||129.08|102.29|
72487534|NCT02232802|144503689|EQUIVALENCE|Results obtained using a fixed effects ANOVA with fixed effects for sequence, period, treatment and subject nested within sequence|Median Difference (Final Values)|0.0|||=|0.8554|TWO_SIDED|95.0|-0.5|0.5|||ANOVA|||||0.5|-0.5|= 0.8554
72514395|NCT04124042|144559626|SUPERIORITY||Odds Ratio (OR)|0.655|||||TWO_SIDED|95.0|0.347|1.237||||||||1.237|0.347|
72403125|NCT02439320|144312189|SUPERIORITY||Odds Ratio, log|1.6|||<|0.001|TWO_SIDED|95.0|1.3|2.1|||Regression, Logistic|||||2.1|1.3|<0.001
72403126|NCT02439320|144312190|SUPERIORITY||Odds Ratio, log|2.4|||<|0.001|TWO_SIDED|95.0|1.8|3.1|||Regression, Logistic|||||3.1|1.8|<0.001
72403127|NCT02439320|144312190|SUPERIORITY||Odds Ratio (OR)|2.5|||<|0.001|TWO_SIDED|95.0|1.9|3.3|||Regression, Logistic|||||3.3|1.9|<0.001
72403128|NCT02439320|144312191|SUPERIORITY||Odds Ratio (OR)|1.7|||=|0.029|TWO_SIDED|95.0|1.1|2.8|||Regression, Logistic|||||2.8|1.1|=0.029
72403129|NCT02439320|144312191|SUPERIORITY||Odds Ratio (OR)|2.1|||=|0.002|TWO_SIDED|95.0|1.3|3.4|||Regression, Logistic|||||3.4|1.3|=0.002
72403130|NCT02439320|144312192|SUPERIORITY||Odds Ratio (OR)|0.4|||<|0.001|TWO_SIDED|95.0|0.3|0.5|||Regression, Logistic|||||0.5|0.3|<0.001
72403131|NCT02439320|144312192|SUPERIORITY||Odds Ratio (OR)|0.3|||<|0.001|TWO_SIDED|95.0|0.2|0.4|||Regression, Logistic|||||0.4|0.2|<0.001
72403132|NCT02439320|144312193|SUPERIORITY||Odds Ratio, log|0.7||||0.12|TWO_SIDED|95.0|0.5|1.1|||Regression, Logistic|||||1.1|0.5|0.120
72487535|NCT02232802|144503690|EQUIVALENCE|Results obtained using a fixed effects ANOVA with fixed effects for sequence, period, treatment and subject nested within sequence|geometric least square mean ratio|100.86|||||TWO_SIDED|95.0|99.27|102.47||||||||102.47|99.27|
72487536|NCT02232802|144503691|EQUIVALENCE|Results obtained using a fixed effects ANOVA with fixed effects for sequence, period, treatment and subject nested within sequence.|geometric least square mean ratio|95.13|||||TWO_SIDED|95.0|85.7|105.6||||||||105.6|85.7|
72403133|NCT02439320|144312193|SUPERIORITY||Odds Ratio (OR)|0.6||||0.035|TWO_SIDED|95.0|0.4|1.0|||Regression, Logistic|||||1.0|0.4|0.035
72403134|NCT02439320|144312195|SUPERIORITY||Odds Ratio (OR)|1.1||||0.386|TWO_SIDED|95.0|0.9|1.4|||Regression, Linear|||||1.4|0.9|0.386
72403135|NCT02439320|144312195|SUPERIORITY||Odds Ratio (OR)|1.1||||0.47|TWO_SIDED|95.0|0.9|1.4|||Regression, Linear|||||1.4|0.9|0.470
72403136|NCT02439320|144312196|SUPERIORITY||Odds Ratio (OR)|1.4||||0.006|TWO_SIDED|95.0|1.1|1.8|||Regression, Logistic|||||1.8|1.1|0.006
72403137|NCT02439320|144312196|SUPERIORITY||Odds Ratio (OR)|1.3||||0.037|TWO_SIDED|95.0|1.0|1.6|||Regression, Logistic|||||1.6|1.0|0.037
72403138|NCT02439320|144312197|SUPERIORITY||Odds Ratio (OR)|1.9|||<|0.001|TWO_SIDED|95.0|1.5|2.4|||Regression, Logistic|||||2.4|1.5|<0.001
72403139|NCT02439320|144312197|SUPERIORITY||Odds Ratio (OR)|1.7|||<|0.001|TWO_SIDED|95.0|1.4|2.2|||Regression, Logistic|||||02.2|1.4|<0.001
72403140|NCT02972632|144312201|OTHER||||||<|0.001|||||||t-test, 2 sided|||Change at Week 6 relative to baseline||||<0.001
72403141|NCT02972632|144312201|OTHER||||||<|0.001|||||||t-test, 2 sided|||Change at Week 12 relative to baseline||||<0.001
72403142|NCT02972632|144312202|OTHER||||||<|0.001|||||||t-test, 2 sided|||Change at Week 6 relative to baseline||||<0.001
72403143|NCT02972632|144312202|OTHER||||||<|0.001|||||||t-test, 2 sided|||Change at Week 12 relative to baseline||||<0.001
72403144|NCT02972632|144312203|OTHER||||||<|0.001|||||||t-test, 2 sided|||Change at Week 6 relative to baseline||||<0.001
72403145|NCT02972632|144312203|OTHER||||||<|0.001|||||||t-test, 2 sided|||Change at Week 12 relative to baseline||||<0.001
72487537|NCT02232802|144503692|EQUIVALENCE|An assessment of tmax was performed using the Wilcoxon matched pairs test. In addition, a 95 % nonparametric CI was constructed for the median difference in tmax based on the method of Campbell and Gardner.|Median Difference (Final Values)|0.0|||=|0.6857|TWO_SIDED|95.0|-0.25|0.5|||Wilcoxon (Mann-Whitney)||Median difference is the difference between median tmax in Test IMP versus Reference IMP arms.|||0.5|-0.25|= 0.6857
72514396|NCT04124042|144559626|SUPERIORITY||Odds Ratio (OR)|0.714|||||TWO_SIDED|95.0|0.381|1.336||||||||1.336|0.381|
72514397|NCT04124042|144559627|SUPERIORITY||Mean Difference (Final Values)|0.44|STANDARD_ERROR_OF_MEAN|0.539||0.413|TWO_SIDED|95.0|-0.62|1.5|||Mixed Models Analysis|||||1.50|-0.62|0.413
72403146|NCT02972632|144312204|OTHER||||||<|0.001|||||||t-test, 2 sided|||Change at Week 12 relative to baseline||||<0.001
72403147|NCT02972632|144312205|OTHER||||||<|0.001|||||||t-test, 2 sided|||Change at Week 12 relative to baseline||||<0.001
72403148|NCT02972632|144312206|OTHER||||||<|0.001|||||||t-test, 2 sided|||Change at Week 12 relative to baseline||||<0.001
72403149|NCT02245841|144312208|SUPERIORITY||||||<|0.001|||||||Wilcoxon signed rank test|||Analysis performed was two-sided Wilcoxon signed rank test. Median differences with interquartile range are reported in outcome measure data.||||< .001
72403150|NCT02245841|144312209|SUPERIORITY||||||<|0.001|||||||Wilcoxon signed rank test|||Analysis performed was two-sided Wilcoxon signed rank test. Median differences with interquartile range are reported in outcome measure data.||||<0.001
72403151|NCT02245841|144312210|SUPERIORITY|||||||0.002|||||||Wilcoxon signed rank test|||Analysis performed was two-sided Wilcoxon signed rank test. Median differences with interquartile range are reported in outcome measure data.||||0.002
72403152|NCT02245841|144312211|SUPERIORITY|||||||0.05|||||||Wilcoxon signed rank test|||Analysis performed was two-sided Wilcoxon signed rank test. Median differences with interquartile range are reported in outcome measure data.||||0.050
72403153|NCT02245841|144312212|SUPERIORITY||||||<|0.001|||||||Wilcoxon signed rank test|||Analysis performed was two-sided Wilcoxon signed rank test. Median differences with interquartile range are reported in outcome measure data.||||<0.001
72403154|NCT01835743|144312216|SUPERIORITY_OR_OTHER||||||<|5e-05|TWO_SIDED||||||Fisher Exact|||||||<0.00005
72403155|NCT01835743|144312217|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|t-test for two independent samples to compare the change in VAS scores across the evaluation period between the two procedure administration groups||||||<0.0001
72403156|NCT01451775|144312218|NON_INFERIORITY_OR_EQUIVALENCE|Bioavailability study with standard bioequivalence range of 80% to 125%. Ratio calculated as empa 25mg fed divided by empa 25mg fasted.|Geometric mean ratio|84.04|STANDARD_DEVIATION|6.4|||TWO_SIDED|90.0|80.856|87.344|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment.|Standard deviation is actually the geometric coefficient of variation.|||87.344|80.856|
72403157|NCT01451775|144312218|NON_INFERIORITY_OR_EQUIVALENCE|This is an analysis of dose proportionality|Slope|0.9367|STANDARD_ERROR_OF_MEAN|0.0178|||TWO_SIDED|95.0|0.8988|0.9746||Does proportionality would be assumed if the 95% confidence interval includes one.|ANCOVA|ANCOVA with logarithm of the dose fitted as a continuous covariate and sequence, subjects within sequence, period included as categorical variables.||||0.9746|0.8988|
72514398|NCT04124042|144559627|SUPERIORITY||Mean Difference (Final Values)|0.26|STANDARD_ERROR_OF_MEAN|0.535||0.629|TWO_SIDED|95.0|-0.79|1.31|||Mixed Models Analysis|||||1.31|-0.79|0.629
72514399|NCT04124042|144559632|SUPERIORITY||Mean Difference (Final Values)|0.5||||0.1374|TWO_SIDED|95.0|-0.16|1.16|||Mixed Models Analysis|||||1.16|-0.16|0.1374
72487538|NCT02232802|144503698|EQUIVALENCE|Results obtained using a fixed effects ANOVA with fixed effects for sequence, period, treatment and subject nested within sequence|Geometric least square mean ratio|111.39|||||TWO_SIDED|95.0|105.89|117.17||||||||117.17|105.89|
72487539|NCT02232802|144503699|EQUIVALENCE|Results obtained using a fixed effects ANOVA with fixed effects for sequence, period, treatment and subject nested within sequence|Geometric least square mean ratio|113.82|||||TWO_SIDED|95.0|107.47|120.53||||||||120.53|107.47|
72487540|NCT02232802|144503704|EQUIVALENCE|An assessment of tmax was performed using the Wilcoxon matched pairs test. In addition, a 95 % nonparametric CI was constructed for the median difference in tmax based on the method of Campbell and Gardner.|Median Difference (Final Values)|0.0|||=|0.9217|TWO_SIDED|95.0|-0.13|0.13|||Wilcoxon (Mann-Whitney)||Median difference is the difference between median tmax in Test IMP versus Reference IMP arms.|||0.13|-0.13|= 0.9217
72487541|NCT00885703|144503710|SUPERIORITY|||||||0.0012||||||Analysis did not adjust for multiple comparisons.|Chi-squared|||Testing discontinuation of any dose Fluconazole (pooled by treatment and dose) versus discontinuation of Ampho B (pooled). The null hypothesis is the two treatments have the same proportion of discontinuation.||||0.0012
72487542|NCT00885703|144503711|SUPERIORITY|||||||0.012|||||||Fisher Exact|||Among 4 treatment arms, comparison of three categorical groups: (CM negative, CM negative after switching treatment, and CM Positive/Died/Lost to Follow-up) at week 10. The null hypothesis is the 4 treatment arms have no differences at week 10.||||0.012
72487543|NCT00885703|144503712|SUPERIORITY|||||||0.019|||||||Kruskal-Wallis|||Comparison of change in quantitative CSF culture among 4 treatment arms. The null hypothesis is the 4 treatment arms have the same change in CSF culture from entry to week 2.||||0.019
72514400|NCT04124042|144559632|SUPERIORITY||Mean Difference (Final Values)|0.35||||0.2807|TWO_SIDED|95.0|-0.29|1.0|||Mixed Models Analysis|||||1.00|-0.29|0.2807
72514401|NCT04124042|144559633|SUPERIORITY||Mean Difference (Final Values)|0.13|STANDARD_ERROR_OF_MEAN|0.142||0.346|TWO_SIDED|95.0|-0.14|0.41|||Mixed Models Analysis|||||0.41|-0.14|0.346
72403158|NCT01451775|144312219|NON_INFERIORITY_OR_EQUIVALENCE|Bioavailability study with standard bioequivalence range of 80% to 125%. Ratio calculated as empa 25mg fed divided by empa 25mg fasted.|Geometric mean ratio|63.22|STANDARD_DEVIATION|18.1|||TWO_SIDED|90.0|56.736|70.439|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment.|Standard deviation is actually the geometric coefficient of variation.|||70.439|56.736|
72514402|NCT04124042|144559633|SUPERIORITY||Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.14||0.968|TWO_SIDED|95.0|-0.27|0.28|||Mixed Models Analysis|||||0.28|-0.27|0.968
72514403|NCT04124042|144559635|SUPERIORITY||Mean Difference (Final Values)|-2.83||||0.0081|TWO_SIDED|95.0|-4.91|-0.75|||Mixed Models Analysis|||Outcome measure #10 is an analysis of 2 tx groups (two doses of 0.45 mg/ml vs. a single dose of 0.45 mg/ml), whereas outcome measure #12 is all 6 tx groups. A MMRM model was used. LS Means in an MMRM model are influenced by the overall mean structure and covariance estimation. When fewer treatment groups are included, the model adjusts based on a different subset of data, leading to potential shifts in estimated LS Means due to changes in the reference population/covariance structure.||-0.75|-4.91|0.0081
72514404|NCT04124042|144559636|SUPERIORITY||Mean Difference (Final Values)|-9.6||||0.0101|TWO_SIDED|95.0|-16.85|-2.34|||Mixed Models Analysis|||Outcome measure #11 is an analysis of 2 tx groups (two doses of 0.45 mg/ml vs. a single dose of 0.45 mg/ml), whereas outcome measure #13 is all 6 tx groups. A MMRM model was used. LS Means in an MMRM model are influenced by the overall mean structure and covariance estimation. When fewer treatment groups are included, the model adjusts based on a different subset of data, leading to potential shifts in estimated LS Means due to changes in the reference population/covariance structure.||-2.34|-16.85|0.0101
72487544|NCT00885703|144503713|SUPERIORITY|||||||0.0894||||||Analysis did not adjust for multiple comparisons.|Log Rank|||Comparison of survival from entry to week 24 between Fluconazole 1200mg arm and Ampho B arm. The null hypothesis is there is no difference in survival between these two arms.||||0.0894
72514405|NCT02662985|144559640|SUPERIORITY||Median Difference (Net)|-3.18|STANDARD_ERROR_OF_MEAN|1.18||0.004|TWO_SIDED|95.0|-5.52|-0.85|||Mixed Models Analysis|mixed model repeated measures (MMRM)||GLOESS scores||-0.85|-5.52|0.0040
72514406|NCT02662985|144559641|SUPERIORITY||Odds Ratio (OR)|4.6|||<|0.0001|TWO_SIDED|95.0|2.38|8.89|||Regression, Logistic|Logistic regression using non-responder imputation||Proportion of patients with ACR 20 response at Week 12 (FAS)||8.89|2.38|<0.0001
72487545|NCT00885703|144503713|SUPERIORITY|||||||0.4828||||||Analysis did not adjust for multiple comparisons.|Log Rank|||Comparison of survival from entry to week 24 between Fluconazole 1600mg arm and Ampho B arm. The null hypothesis is there is no difference in survival between these two arms.||||0.4828
72487546|NCT00885703|144503713|SUPERIORITY|||||||0.1766||||||Analysis did not adjust for multiple comparisons.|Log Rank|||Comparison of survival from entry to week 24 between Fluconazole 2000mg arm and Ampho B arm. The null hypothesis is there is no difference in survival between these two arms.||||0.1766
72487547|NCT02015442|144503757|SUPERIORITY|||||||0.39|||||||t-test, 2 sided|||Baseline vs. treatment period||||0.390
72487548|NCT02015442|144503757|SUPERIORITY|||||||0.204|||||||t-test, 2 sided|||Baseline vs treatment||||0.204
72487549|NCT02015442|144503758|SUPERIORITY|||||||0.001||||||calculated|t-test, 2 sided|||Baseline vs treatment||||0.001
72487550|NCT02015442|144503758|SUPERIORITY|||||||0.244|||||||t-test, 2 sided|||Baseline vs treatment||||0.244
72487551|NCT02015442|144503758|SUPERIORITY|||||||0.244|||||||ANOVA|||||||0.244
72514407|NCT02662985|144559642|SUPERIORITY||Odds Ratio (OR)|9.65|||<|0.0001|TWO_SIDED|95.0|3.92|23.75|||Regression, Logistic|||Proportion of patients with ACR 50 response at Week 12 (FAS)||23.75|3.92|<0.0001
72514408|NCT02662985|144559643|SUPERIORITY||Adjusted mean of treatment difference|-0.67|STANDARD_ERROR_OF_MEAN|0.36||0.0327|TWO_SIDED|95.0|-1.374|0.043|||Regression, Logistic|||SPARCC||0.043|-1.374|0.0327
72514409|NCT01486784|144559650|OTHER||||||||||||||||||Based on the dose limiting toxicities occurring in each dosing cohort, a maximum tolerated dose (MTD) may be determined by assessing the highest dosing level presenting no dose limiting toxicities. An MTD of 17mg/m2 twice weekly was established.|||
72577047|NCT01371747|144680801|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||P-Value \<0.001|ANCOVA|||Each starting dose group was compared to its baseline.||||<0.001
72577048|NCT01371747|144680801|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||P-value \<0.001|ANCOVA|||Each starting dose group was compared to its baseline.||||<0.001
72577049|NCT01371747|144680801|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||P-value \<0.001|ANCOVA|||Each starting dose group was compared to its baseline.||||<0.001
72487552|NCT03596866|144503778|SUPERIORITY||Hazard Ratio (HR)|0.968|||=|0.8672|TWO_SIDED|95.0|0.658|1.424||P-value from a 2-sided stratified log-rank test using the stratification factors: presence of intracranial central nervous system (CNS) metastases at baseline, and best prior response to crizotinib therapy as assessed by the investigator.|2-sided Stratified Log-rank Test||The hazard ratio was obtained using the stratified Cox regression model with the same stratification factors.|||1.424|0.658|=0.8672
72487553|NCT03596866|144503779|SUPERIORITY||Hazard Ratio (HR)|1.592|||=|0.0713|TWO_SIDED|95.0|0.956|2.652||P-value was based on a 2-sided stratified log-rank test using the stratification factors: presence of intracranial CNS metastases at baseline and best prior response to crizotinib therapy as assessed by the investigator.|Log Rank||The HR was obtained using the stratified Cox regression model with the same stratification factors.|||2.652|0.956|=0.0713
72403159|NCT01451775|144312219|NON_INFERIORITY_OR_EQUIVALENCE|This is an analysis of dose proportionality|Slope|0.9065|STANDARD_DEVIATION|0.0495|||TWO_SIDED|95.0|0.8011|1.012||Does proportionality would be assumed if the 95% confidence interval includes one.|ANCOVA|ANCOVA with logarithm of the dose fitted as a continuous covariate and sequence, subjects within sequence, period included as categorical variables.||||1.0120|0.8011|
72487554|NCT03596866|144503780|SUPERIORITY||Hazard Ratio (HR)|1.232|||=|0.2501|TWO_SIDED|95.0|0.862|1.761||P-value was based on a 2-sided stratified log-rank test using the stratification factors: presence of intracranial CNS metastases at baseline and best prior response to crizotinib therapy as assessed by the investigator.|Log Rank||The HR was obtained using the stratified Cox regression model with the same stratification factors.|||1.761|0.862|=0.2501
72514410|NCT01021852|144559656|SUPERIORITY_OR_OTHER||Difference in LS Means|8.4|STANDARD_ERROR_OF_MEAN|1.59|<|0.001|TWO_SIDED|95.0|5.3|11.5|||Mixed Models Analysis|||"MK-6096 2.5 mg vs. Placebo at Night 1~A mixed effects model with terms for baseline value, geographic region (Japan vs. ex-Japan), gender, treatment, sequence, period, time, and treatment-by-time interaction and period-by-time interaction was used to estimate LS mean differences between MK-6096 and placebo at Night 1. 95% confidence interval estimate and p-value (based upon a normal approximation) were also computed from the LS mean differences and variability estimates from the model."||11.5|5.3|<0.001
72514411|NCT01021852|144559656|SUPERIORITY_OR_OTHER||Difference in LS Means|9.9|STANDARD_ERROR_OF_MEAN|1.59|<|0.001|TWO_SIDED|95.0|6.8|13.1|||Mixed Models Analysis|||"MK-6096 5 mg vs. Placebo at Night 1~A mixed effects model with terms for baseline value, geographic region (Japan vs. ex-Japan), gender, treatment, sequence, period, time, and treatment-by-time interaction and period-by-time interaction was used to estimate LS mean differences between MK-6096 and placebo at Night 1. 95% confidence interval estimate and p-value (based upon a normal approximation) were also computed from the LS mean differences and variability estimates from the model."||13.1|6.8|<0.001
72514412|NCT01021852|144559656|SUPERIORITY_OR_OTHER||Difference in LS Means|10.7|STANDARD_ERROR_OF_MEAN|1.57|<|0.001|TWO_SIDED|95.0|7.7|13.8|||Mixed Models Analysis|||"MK-6096 10 mg vs. Placebo at Night 1~A mixed effects model with terms for baseline value, geographic region (Japan vs. ex-Japan), gender, treatment, sequence, period, time, and treatment-by-time interaction and period-by-time interaction was used to estimate LS mean differences between MK-6096 and placebo at Night 1. 95% confidence interval estimate and p-value (based upon a normal approximation) were also computed from the LS mean differences and variability estimates from the model."||13.8|7.7|<0.001
72514413|NCT01021852|144559656|SUPERIORITY_OR_OTHER||Difference in LS Means|13.4|STANDARD_ERROR_OF_MEAN|1.57|<|0.001|TWO_SIDED|95.0|10.3|16.5|||Mixed Models Analysis|||"MK-6096 20 mg vs. Placebo at Night 1~A mixed effects model with terms for baseline value, geographic region (Japan vs. ex-Japan), gender, treatment, sequence, period, time, and treatment-by-time interaction and period-by-time interaction was used to estimate LS mean differences between MK-6096 and placebo at Night 1. 95% confidence interval estimate and p-value (based upon a normal approximation) were also computed from the LS mean differences and variability estimates from the model."||16.5|10.3|<0.001
72514414|NCT01021852|144559656|SUPERIORITY_OR_OTHER||Difference in LS Means|4.6|STANDARD_ERROR_OF_MEAN|1.42||0.001|TWO_SIDED|95.0|1.8|7.4|||Mixed Models Analysis|||"MK-6096 2.5 mg vs. Placebo at Week 4~A mixed effects model with terms for baseline value, geographic region (Japan vs. ex-Japan), gender, treatment, sequence, period, time, and treatment-by-time interaction and period-by-time interaction was used to estimate LS mean differences between MK-6096 and placebo at Week 4. 95% confidence interval estimate and p-value (based upon a normal approximation) were also computed from the LS mean differences and variability estimates from the model."||7.4|1.8|0.001
72514415|NCT01021852|144559656|SUPERIORITY_OR_OTHER||Difference in LS Means|4.1|STANDARD_ERROR_OF_MEAN|1.42||0.004|TWO_SIDED|95.0|1.3|6.9|||Mixed Models Analysis|||"MK-6096 5 mg vs. Placebo at Week 4~A mixed effects model with terms for baseline value, geographic region (Japan vs. ex-Japan), gender, treatment, sequence, period, time, and treatment-by-time interaction and period-by-time interaction was used to estimate LS mean differences between MK-6096 and placebo at Week 4. 95% confidence interval estimate and p-value (based upon a normal approximation) were also computed from the LS mean differences and variability estimates from the model."||6.9|1.3|0.004
72514416|NCT01021852|144559656|SUPERIORITY_OR_OTHER||Difference in LS Means|9.7|STANDARD_ERROR_OF_MEAN|1.43|<|0.001|TWO_SIDED|95.0|6.9|12.5|||Mixed Models Analysis|||"MK-6096 10 mg vs. Placebo at Week 4~A mixed effects model with terms for baseline value, geographic region (Japan vs. ex-Japan), gender, treatment, sequence, period, time, and treatment-by-time interaction and period-by-time interaction was used to estimate LS mean differences between MK-6096 and placebo at Week 4. 95% confidence interval estimate and p-value (based upon a normal approximation) were also computed from the LS mean differences and variability estimates from the model."||12.5|6.9|<0.001
72514417|NCT01021852|144559656|SUPERIORITY_OR_OTHER||Difference in LS Means|8.7|STANDARD_ERROR_OF_MEAN|1.43|<|0.001|TWO_SIDED|95.0|5.9|11.5|||Mixed Models Analysis|||"MK-6096 20 mg vs. Placebo at Week 4~A mixed effects model with terms for baseline value, geographic region (Japan vs. ex-Japan), gender, treatment, sequence, period, time, and treatment-by-time interaction and period-by-time interaction was used to estimate LS mean differences between MK-6096 and placebo at Week 4. 95% confidence interval estimate and p-value (based upon a normal approximation) were also computed from the LS mean differences and variability estimates from the model."||11.5|5.9|<0.001
72577050|NCT01371747|144680801|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||P-value \<0.001|ANCOVA|||Each starting dose group was compared to its baseline.||||<0.001
72403160|NCT03441633|144312221|SUPERIORITY||Odds Ratio (OR)|0.74||||0|TWO_SIDED|95.0|0.68|0.82|||Chi-squared|||Dabigatran vs. Apixaban in naive participants (Non-smoker)||0.82|0.68|0.000
72403161|NCT03441633|144312221|SUPERIORITY||Odds Ratio (OR)|1.32||||0|TWO_SIDED|95.0|1.14|1.52|||Chi-squared|||Dabigatran vs. Apixaban in naive participants (Ex-smoker)||1.52|1.14|0.000
72403162|NCT03441633|144312221|SUPERIORITY||Odds Ratio (OR)|1.04||||0|TWO_SIDED|95.0|0.93|1.17|||Chi-squared|||Dabigatran vs. Apixaban in naive participants (Smoker)||1.17|0.93|0.000
72487555|NCT03596866|144503781|SUPERIORITY||Odds Ratio (OR)|0.7|||=|0.1555|TWO_SIDED|95.0|0.42|1.15||P-value was from a Cochran-Mantel-Haenszel test stratified by the stratification factors: presence of intracranial CNS metastases at baseline and best prior response to crizotinib therapy as assessed by the investigator.|Cochran-Mantel-Haenszel||Odds ratio stratified by the stratification factors: presence of intracranial CNS metastases at baseline and best prior response to crizotinib therapy as assessed by the investigator.|BIRC Assessed||1.15|0.42|=0.1555
72403163|NCT03441633|144312221|SUPERIORITY||Odds Ratio (OR)|0.95||||0.755|TWO_SIDED|95.0|0.8|1.13|||Chi-squared|||Dabigatran vs. Apixaban in non-naive participants (Non-smoker)||1.13|0.80|0.755
72403164|NCT03441633|144312221|SUPERIORITY||Odds Ratio (OR)|1.32||||0.426|TWO_SIDED|95.0|0.95|1.83|||Chi-squared|||Dabigatran vs. Apixaban in non-naive participants (Ex-smoker)||1.83|0.95|0.426
72487556|NCT03596866|144503781|SUPERIORITY||Odds Ratio (OR)|0.55|||=|0.0169|TWO_SIDED|95.0|0.33|0.9||P-value was from a Cochran-Mantel-Haenszel test stratified by the stratification factors: presence of intracranial CNS metastases at baseline and best prior response to crizotinib therapy as assessed by the investigator.|Cochran-Mantel-Haenszel||Odds ratio stratified by the stratification factors: presence of intracranial CNS metastases at baseline and best prior response to crizotinib therapy as assessed by the investigator.|Investigator Assessed||0.90|0.33|=0.0169
72487557|NCT03596866|144503784|SUPERIORITY||Odds Ratio (OR)|1.31|||=|0.6246|TWO_SIDED|95.0|0.44|3.84||P-value was from a Cochran-Mantel-Haenszel test stratified by best prior response to crizotinib therapy as assessed by the investigator at randomization per IXRS.|Cochran-Mantel-Haenszel||Odds ratio was stratified by best prior response to crizotinib therapy as assessed by the investigator at randomization per IXRS.|||3.84|0.44|=0.6246
72487558|NCT03596866|144503786|SUPERIORITY||||||=|0.0778||||||P-value from a 2-sided stratified Gray's test using the stratification factors (at randomization per IxRS): presence of intracranial CNS metastases at baseline, and best prior response to crizotinib therapy as assessed by the investigator.|Gray's Test|P-value is for the event type: Intracranial Disease Progression without Prior Systemic Progression or Death.||||||=0.0778
72487559|NCT02904915|144503796|SUPERIORITY|||||||0.59|||||||Fisher Exact|||||||0.59
72487560|NCT02904915|144503797|SUPERIORITY|||||||0.39|||||||Fisher Exact|||||||0.39
72487561|NCT02904915|144503798|SUPERIORITY|||||||0.23|||||||Fisher Exact|||||||0.23
72487562|NCT00262522|144503799|SUPERIORITY_OR_OTHER||||||>|0.1||95.0|||||Cochran-Mantel-Haenszel|||Cochran-Mantel-Haenszel (CMH) test stratified by dosing regimen was used to assess the null hypothesis of no difference between the tablet and soft gel capsule (SGC). Sample size was 600 subjects (150 each in the 4 groups). Based on a projected 48% reporting treatment-emergent diarrhea in the QD arm and 32% in the BID arm within the SGC group, with a 12% reduction in the corresponding tablet groups, this sample size provided 80% power to determine a difference between the tablet and SGC.||||>0.100
72487563|NCT00262522|144503800|NON_INFERIORITY_OR_EQUIVALENCE|The 95% confidence interval for the difference in response rates (QD minus BID, based on the normal approximation to the binomial distribution) was used to assess noninferiority. The QD regimen was considered noninferior to the BID regimen if the lower limit of the confidence interval remained above -12%.|percentage of subjects responding|1.3||||0.715||95.0|-5.1|7.8|||normal approx. to the binomial distr.|||The null hypothesis was that the response rate for the once daily (QD) regimen was more than 12% lower than the response rate for the twice daily (BID) regimen. The planned sample size of 600 subjects (300 subjects in each of the QD and BID treatment regimens) provided over 90% power to reject the null hypothesis, i.e., to determine noninferiority based on the 12% margin.||7.8|-5.1|0.715
72487564|NCT00262522|144503801|NON_INFERIORITY_OR_EQUIVALENCE|The 95% confidence interval for the difference in response rates (QD minus BID, based on the normal approximation to the binomial distribution) was used to assess noninferiority. The QD regimen was considered noninferior to the BID regimen if the lower limit of the confidence interval remained above -12%.|percentage of subjects responding|-4.3||||0.249||95.0|-11.5|2.8|||normal approx. to the binomial distr.|||The null hypothesis was that the response rate for the once daily (QD) regimen was more than 12% lower than the response rate for the twice daily (BID) regimen. The planned sample size of 600 subjects (300 subjects in each of the QD and BID treatment regimens) provided over 90% power to reject the null hypothesis, i.e., to determine noninferiority based on the 12% margin.||2.8|-11.5|0.249
72487565|NCT00262522|144503802|SUPERIORITY_OR_OTHER|||||||0.269||95.0|||||ANOVA|||||||0.269
72487566|NCT03159091|144503803|SUPERIORITY|||||||0.0422|||||||G-test (Chi-square)|||||||0.0422
72487567|NCT03159091|144503804|SUPERIORITY|||||||0.1101|||||||Wilcoxon (Mann-Whitney)|||This analysis applies to ∆ between initial and 4 weeks total scores row.||||0.1101
72487568|NCT03159091|144503805|SUPERIORITY|||||||0.1373|||||||G-test (Chi-square)|||||||0.1373
72487569|NCT03159091|144503806|SUPERIORITY|||||||0.087|||||||Wilcoxon (Mann-Whitney)|||||||0.0870
72487570|NCT03159091|144503807|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.0
72487571|NCT03740165|144503808|SUPERIORITY||Hazard Ratio (HR)|0.66||||0.0002|TWO_SIDED|95.0|0.53|0.83||One-sided p-value based on log-rank test stratified by debulking surgery (planned interval vs R0 following primary vs R1 following primary) and bevacizumab use (Yes vs No)|Log Rank||Based on Cox regression model with Efron's method of tie handling; treatment as covariate stratified by debulking surgery (planned interval vs R0 following primary vs R1 following primary) and bevacizumab use (Yes vs No)|||0.83|0.53|0.0002
72577051|NCT01371747|144680801|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||P-value \<0.001|ANCOVA|||Each starting dose group was compared to its baseline.||||<0.001
72403165|NCT03441633|144312221|SUPERIORITY||Odds Ratio (OR)|0.93||||0.93|TWO_SIDED|95.0|0.77|1.12|||Chi-squared|||Dabigatran vs. Apixaban in non-naive participants (Smoker)||1.12|0.77|0.930
72577052|NCT01371747|144680802|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||P-Value \<0.001|ANCOVA|||Each starting dose group was compared to its baseline.||||<0.001
72403166|NCT03441633|144312221|SUPERIORITY||Odds Ratio (OR)|0.78||||0|TWO_SIDED|95.0|0.72|0.84|||Chi-squared|||Rivaroxaban vs. Apixaban in naive participants (Non-smoker)||0.84|0.72|0.000
72403167|NCT03441633|144312221|SUPERIORITY||Odds Ratio (OR)|1.25||||0|TWO_SIDED|95.0|1.1|1.42|||Chi-squared|||Rivaroxaban vs. Apixaban in naive participants (Ex-smoker)||1.42|1.10|0.000
72514418|NCT01021852|144559657|SUPERIORITY_OR_OTHER||Difference in LS Means|-30.8|STANDARD_ERROR_OF_MEAN|6.29|<|0.001|TWO_SIDED|95.0|-43.2|-18.4|||Mixed Models Analysis|||"MK-6096 2.5 mg vs. Placebo at Night 1~A mixed effects model with terms for baseline value, geographic region (Japan vs. ex-Japan), gender, treatment, sequence, period, time, and treatment-by-time interaction and period-by-time interaction was used to estimate LS mean differences between MK-6096 and placebo at Night 1. 95% confidence interval estimate and p-value (based upon a normal approximation) were also computed from the LS mean differences and variability estimates from the model."||-18.4|-43.2|<0.001
72514419|NCT01021852|144559657|SUPERIORITY_OR_OTHER||Difference in LS Means|-32.5|STANDARD_ERROR_OF_MEAN|6.31|<|0.001|TWO_SIDED|95.0|-44.9|-20.1|||Mixed Models Analysis|||"MK-6096 5 mg vs. Placebo at Night 1~A mixed effects model with terms for baseline value, geographic region (Japan vs. ex-Japan), gender, treatment, sequence, period, time, and treatment-by-time interaction and period-by-time interaction was used to estimate LS mean differences between MK-6096 and placebo at Night 1. 95% confidence interval estimate and p-value (based upon a normal approximation) were also computed from the LS mean differences and variability estimates from the model."||-20.1|-44.9|<0.001
72514420|NCT01021852|144559657|SUPERIORITY_OR_OTHER||Difference in LS Means|-30.9|STANDARD_ERROR_OF_MEAN|6.21|<|0.001|TWO_SIDED|95.0|-43.2|-18.7|||Mixed Models Analysis|||"MK-6096 10 mg vs. Placebo at Night 1~A mixed effects model with terms for baseline value, geographic region (Japan vs. ex-Japan), gender, treatment, sequence, period, time, and treatment-by-time interaction and period-by-time interaction was used to estimate LS mean differences between MK-6096 and placebo at Night 1. 95% confidence interval estimate and p-value (based upon a normal approximation) were also computed from the LS mean differences and variability estimates from the model."||-18.7|-43.2|<0.001
72514421|NCT01021852|144559657|SUPERIORITY_OR_OTHER||Difference in LS Means|-45.8|STANDARD_ERROR_OF_MEAN|6.22|<|0.001|TWO_SIDED|95.0|-58.0|-33.5|||Mixed Models Analysis|||"MK-6096 20 mg vs. Placebo at Night 1~A mixed effects model with terms for baseline value, geographic region (Japan vs. ex-Japan), gender, treatment, sequence, period, time, and treatment-by-time interaction and period-by-time interaction was used to estimate LS mean differences between MK-6096 and placebo at Night 1. 95% confidence interval estimate and p-value (based upon a normal approximation) were also computed from the LS mean differences and variability estimates from the model."||-33.5|-58.0|<0.001
72514422|NCT01021852|144559657|SUPERIORITY_OR_OTHER||Difference in LS Means|-15.5|STANDARD_ERROR_OF_MEAN|5.65||0.006|TWO_SIDED|95.0|-26.7|-4.4|||Mixed Models Analysis|||"MK-6096 2.5 mg vs. Placebo at Week 4~A mixed effects model with terms for baseline value, geographic region (Japan vs. ex-Japan), gender, treatment, sequence, period, time, and treatment-by-time interaction and period-by-time interaction was used to estimate LS mean differences between MK-6096 and placebo at Week 4. 95% confidence interval estimate and p-value (based upon a normal approximation) were also computed from the LS mean differences and variability estimates from the model."||-4.4|-26.7|0.006
72514423|NCT01021852|144559657|SUPERIORITY_OR_OTHER||Difference in LS Means|-13.2|STANDARD_ERROR_OF_MEAN|5.66||0.02|TWO_SIDED|95.0|-24.4|-2.1|||Mixed Models Analysis|||"MK-6096 5 mg vs. Placebo at Week 4~A mixed effects model with terms for baseline value, geographic region (Japan vs. ex-Japan), gender, treatment, sequence, period, time, and treatment-by-time interaction and period-by-time interaction was used to estimate LS mean differences between MK-6096 and placebo at Week 4. 95% confidence interval estimate and p-value (based upon a normal approximation) were also computed from the LS mean differences and variability estimates from the model."||-2.1|-24.4|0.020
72514424|NCT01021852|144559657|SUPERIORITY_OR_OTHER||Difference in LS Means|-25.7|STANDARD_ERROR_OF_MEAN|5.67|<|0.001|TWO_SIDED|95.0|-36.8|-14.5|||Mixed Models Analysis|||"MK-6096 10 mg vs. Placebo at Week 4~A mixed effects model with terms for baseline value, geographic region (Japan vs. ex-Japan), gender, treatment, sequence, period, time, and treatment-by-time interaction and period-by-time interaction was used to estimate LS mean differences between MK-6096 and placebo at Week 4. 95% confidence interval estimate and p-value (based upon a normal approximation) were also computed from the LS mean differences and variability estimates from the model."||-14.5|-36.8|<0.001
72514425|NCT01021852|144559657|SUPERIORITY_OR_OTHER||Difference in LS Means|-30.0|STANDARD_ERROR_OF_MEAN|5.69|<|0.001|TWO_SIDED|95.0|-41.2|-18.8|||Mixed Models Analysis|||"MK-6096 20 mg vs. Placebo at Week 4~A mixed effects model with terms for baseline value, geographic region (Japan vs. ex-Japan), gender, treatment, sequence, period, time, and treatment-by-time interaction and period-by-time interaction was used to estimate LS mean differences between MK-6096 and placebo at Week 4. 95% confidence interval estimate and p-value (based upon a normal approximation) were also computed from the LS mean differences and variability estimates from the model."||-18.8|-41.2|<0.001
72514426|NCT01021852|144559658|SUPERIORITY_OR_OTHER||Difference in LS Means|-10.2|STANDARD_ERROR_OF_MEAN|4.43||0.022|TWO_SIDED|95.0|-18.9|-1.5|||Mixed Models Analysis|||"MK-6096 2.5 mg vs. Placebo at Night 1~A mixed effects model with terms for baseline value, geographic region (Japan vs. ex-Japan), gender, treatment, sequence, period, time, and treatment-by-time interaction and period-by-time interaction was used to estimate LS mean differences between MK-6096 and placebo at Night 1. 95% confidence interval estimate and p-value (based upon a normal approximation) were also computed from the LS mean differences and variability estimates from the model."||-1.5|-18.9|0.022
72577053|NCT01371747|144680802|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||P-Value \<0.001|ANCOVA|||Each starting dose group was compared to its baseline.||||<0.001
72403168|NCT03441633|144312221|SUPERIORITY||Odds Ratio (OR)|1.08||||0|TWO_SIDED|95.0|0.98|1.19|||Chi-squared|||Rivaroxaban vs. Apixaban in naive participants (Smoker)||1.19|0.98|0.000
72403169|NCT03441633|144312221|SUPERIORITY||Odds Ratio (OR)|0.98||||0.755|TWO_SIDED|95.0|0.84|1.14|||Chi-squared|||Rivaroxaban vs. Apixaban in non-naive participants (Non-smoker)||1.14|0.84|0.755
72403170|NCT03441633|144312221|SUPERIORITY||Odds Ratio (OR)|1.13||||0.426|TWO_SIDED|95.0|0.84|1.52|||Chi-squared|||Rivaroxaban vs. Apixaban in non-naive participants (Ex-smoker)||1.52|0.84|0.426
72403171|NCT03441633|144312221|SUPERIORITY||Odds Ratio (OR)|0.98||||0.93|TWO_SIDED|95.0|0.81|1.12|||Chi-squared|||Rivaroxaban vs. Apixaban in non-naive participants (Smoker)||1.12|0.81|0.930
72403172|NCT03441633|144312221|SUPERIORITY||Odds Ratio (OR)|0.79||||0|TWO_SIDED|95.0|0.74|0.84|||Chi-squared|||Acenocoumarol vs. Apixaban in naive participants (Non-smoker)||0.84|0.74|0.000
72577054|NCT01371747|144680802|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||P-value \<0.001|ANCOVA|||Each starting dose group was compared to its baseline.||||<0.001
72577055|NCT01371747|144680802|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||P-value \<0.001|ANCOVA|||Each starting dose group was compared to its baseline.||||<0.001
72487572|NCT03740165|144503808|SUPERIORITY||Hazard Ratio (HR)|0.95||||0.3339|TWO_SIDED|95.0|0.77|1.19||One-sided p-value based on log-rank test stratified by debulking surgery (planned interval vs R0 following primary vs R1 following primary) and bevacizumab use (Yes vs No)|Log Rank||Based on Cox regression model with Efron's method of tie handling; treatment as covariate stratified by debulking surgery (planned interval vs R0 following primary vs R1 following primary) and bevacizumab use (Yes vs No)|||1.19|0.77|0.3339
72403173|NCT03441633|144312221|SUPERIORITY||Odds Ratio (OR)|1.19||||0|TWO_SIDED|95.0|1.08|1.32|||Chi-squared|||Acenocoumarol vs. Apixaban in naive participants (Ex-smoker)||1.32|1.08|0.000
72403174|NCT03441633|144312221|SUPERIORITY||Odds Ratio (OR)|1.16||||0|TWO_SIDED|95.0|1.08|1.26|||Chi-squared|||Acenocoumarol vs. Apixaban in naive participants (Smoker)||1.26|1.08|0.000
72487573|NCT03740165|144503809|SUPERIORITY||Hazard Ratio (HR)|0.71|||<|0.0001|TWO_SIDED|95.0|0.61|0.84||One-sided p-value based on log-rank test stratified by debulking surgery (planned interval vs R0 following primary vs R1 following primary), bevacizumab use (Yes vs No), and PD-L1 CPS (\<10 vs ≥10)|Log Rank||Based on Cox regression model with Efron's method of tie handling; treatment as covariate stratified by debulking surgery (planned interval vs R0 following primary vs R1 following primary), bevacizumab use (Yes vs No), and PD-L1 CPS (\<10 vs ≥10)|||0.84|0.61|<0.0001
72487574|NCT03740165|144503809|SUPERIORITY||Hazard Ratio (HR)|1.01||||0.5527|TWO_SIDED|95.0|0.87|1.18||One-sided p-value based on log-rank test stratified by debulking surgery (planned interval vs R0 following primary vs R1 following primary), bevacizumab use (Yes vs No), and PD-L1 CPS (\<10 vs ≥10)|Log Rank||Based on Cox regression model with Efron's method of tie handling; treatment as covariate stratified by debulking surgery (planned interval vs R0 following primary vs R1 following primary), bevacizumab use (Yes vs No), and PD-L1 CPS (\<10 vs ≥10)|||1.18|0.87|0.5527
72487575|NCT03740165|144503810|SUPERIORITY||Hazard Ratio (HR)|0.98||||0.4314|TWO_SIDED|95.0|0.75|1.27||One-sided p-value based on log-rank test stratified by debulking surgery (planned interval vs R0 following primary vs R1 following primary) and bevacizumab use (Yes vs No)|Log Rank||Based on Cox regression model with Efron's method of tie handling; treatment as covariate stratified by debulking surgery (planned interval vs R0 following primary vs R1 following primary) and bevacizumab use (Yes vs No)|||1.27|0.75|0.4314
72487576|NCT03740165|144503810|SUPERIORITY||Hazard Ratio (HR)|0.94||||0.3107|TWO_SIDED|95.0|0.72|1.22||One-sided p-value based on log-rank test stratified by debulking surgery (planned interval vs R0 following primary vs R1 following primary) and bevacizumab use (Yes vs No)|Log Rank||Based on Cox regression model with Efron's method of tie handling; treatment as covariate stratified by debulking surgery (planned interval vs R0 following primary vs R1 following primary) and bevacizumab use (Yes vs No)|||1.22|0.72|0.3107
72514427|NCT01021852|144559658|SUPERIORITY_OR_OTHER||Difference in LS Means|-15.7|STANDARD_ERROR_OF_MEAN|4.44|<|0.001|TWO_SIDED|95.0|-24.5|-7.0|||Mixed Models Analysis|||"MK-6096 5 mg vs. Placebo at Night 1~A mixed effects model with terms for baseline value, geographic region (Japan vs. ex-Japan), gender, treatment, sequence, period, time, and treatment-by-time interaction and period-by-time interaction was used to estimate LS mean differences between MK-6096 and placebo at Night 1. 95% confidence interval estimate and p-value (based upon a normal approximation) were also computed from the LS mean differences and variability estimates from the model."||-7.0|-24.5|<0.001
72514428|NCT01021852|144559658|SUPERIORITY_OR_OTHER||Difference in LS Means|-23.5|STANDARD_ERROR_OF_MEAN|4.38|<|0.001|TWO_SIDED|95.0|-32.1|-14.9|||Mixed Models Analysis|||"MK-6096 10 mg vs. Placebo at Night 1~A mixed effects model with terms for baseline value, geographic region (Japan vs. ex-Japan), gender, treatment, sequence, period, time, and treatment-by-time interaction and period-by-time interaction was used to estimate LS mean differences between MK-6096 and placebo at Night 1. 95% confidence interval estimate and p-value (based upon a normal approximation) were also computed from the LS mean differences and variability estimates from the model."||-14.9|-32.1|<0.001
72403175|NCT03441633|144312221|SUPERIORITY||Odds Ratio (OR)|0.82||||0.755|TWO_SIDED|95.0|0.6|1.13|||Chi-squared|||Acenocoumarol vs. Apixaban in non-naive participants (Non-smoker)||1.13|0.60|0.755
72577056|NCT01371747|144680802|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||P-value \<0.001|ANCOVA|||Each starting dose group was compared to its baseline.||||<0.001
72577057|NCT01371747|144680802|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||P-value \<0.001|ANCOVA|||Each starting dose group was compared to its baseline.||||<0.001
72577058|NCT01371747|144680803|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||P-Value \<0.001|ANCOVA|||Each starting dose group was compared to its baseline.||||<0.001
72577059|NCT01371747|144680803|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||P-Value \<0.001|ANCOVA|||Each starting dose group was compared to its baseline.||||<0.001
72577060|NCT01371747|144680803|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||P-value \<0.001|ANCOVA|||Each starting dose group was compared to its baseline.||||<0.001
72577061|NCT01371747|144680803|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||P-value \<0.001|ANCOVA|||Each starting dose group was compared to its baseline.||||<0.001
72403176|NCT03441633|144312221|SUPERIORITY||Odds Ratio (OR)|1.48||||0.426|TWO_SIDED|95.0|0.82|2.52|||Chi-squared|||Acenocoumarol vs. Apixaban in non-naive participants (Ex-smoker)||2.52|0.82|0.426
72577062|NCT01371747|144680803|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||P-value \<0.001|ANCOVA|||Each starting dose group was compared to its baseline.||||<0.001
72577063|NCT01371747|144680803|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||P-value \<0.001|ANCOVA|||Each starting dose group was compared to its baseline.||||<0.001
72577064|NCT01371747|144680804|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.54|||||TWO_SIDED||||||||Estimated values were based on summary statistics.|Each starting dose group was compared to its baseline.||||
72577065|NCT01371747|144680804|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.44|||||TWO_SIDED||||||||Estimated values were based on summary statistics.|Each starting dose group was compared to its baseline.||||
72403177|NCT03441633|144312221|SUPERIORITY||Odds Ratio (OR)|1.0||||0.93|TWO_SIDED|95.0|0.7|1.4|||Chi-squared|||Acenocoumarol vs. Apixaban in non-naive participants (Smoker)||1.40|0.70|0.930
72403178|NCT03441633|144312221|SUPERIORITY||Odds Ratio (OR)|0.54||||0|TWO_SIDED|95.0|0.49|0.6|||Chi-squared|||Warfarin vs. Apixaban in naive participants (Non-smoker)||0.60|0.49|0.000
72567983|NCT02037165|144667471|SUPERIORITY_OR_OTHER||adjusted mean difference|0.52|STANDARD_ERROR_OF_MEAN|1.1566|||TWO_SIDED|95.0|-1.8|2.8|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 1:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||2.8|-1.8|
72487577|NCT03740165|144503811|SUPERIORITY||Hazard Ratio (HR)|1.04||||0.6716|TWO_SIDED|95.0|0.87|1.25||One-sided p-value based on log-rank test stratified by debulking surgery (planned interval vs R0 following primary vs R1 following primary), bevacizumab use (Yes vs No), and PD-L1 CPS (\<10 vs ≥10)|Log Rank||Based on Cox regression model with Efron's method of tie handling; treatment as covariate stratified by debulking surgery (planned interval vs R0 following primary vs R1 following primary), bevacizumab use (Yes vs No), and PD-L1 CPS (\<10 vs ≥10)|||1.25|0.87|0.6716
72567984|NCT02037165|144667471|SUPERIORITY_OR_OTHER||adjusted mean difference|1.89|STANDARD_ERROR_OF_MEAN|1.1565|||TWO_SIDED|95.0|-0.4|4.2|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 2:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||4.2|-0.4|
72567985|NCT02037165|144667471|SUPERIORITY_OR_OTHER||adjusted mean difference|1.25|STANDARD_ERROR_OF_MEAN|1.1564|||TWO_SIDED|95.0|-1.0|3.5|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 3:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||3.5|-1.0|
72567986|NCT02037165|144667471|SUPERIORITY_OR_OTHER||adjusted mean difference|0.67|STANDARD_ERROR_OF_MEAN|1.1564|||TWO_SIDED|95.0|-1.6|2.9|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 4:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||2.9|-1.6|
72567987|NCT02037165|144667471|SUPERIORITY_OR_OTHER||adjusted mean difference of 200 mg BI mi|-0.43|STANDARD_ERROR_OF_MEAN|1.1564|||TWO_SIDED|95.0|-2.7|1.8|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 5:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||1.8|-2.7|
72567988|NCT02037165|144667471|SUPERIORITY_OR_OTHER||adjusted mean difference|-0.76|STANDARD_ERROR_OF_MEAN|1.1565|||TWO_SIDED|95.0|-3.0|1.5|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 6:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||1.5|-3.0|
72567989|NCT02037165|144667471|SUPERIORITY_OR_OTHER||adjusted mean difference|0.09|STANDARD_ERROR_OF_MEAN|1.1566|||TWO_SIDED|95.0|-2.2|2.4|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 22:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||2.4|-2.2|
72567990|NCT02037165|144667471|SUPERIORITY_OR_OTHER||adjusted mean difference|-0.71|STANDARD_ERROR_OF_MEAN|1.1567|||TWO_SIDED|95.0|-3.0|1.6|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 24:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||1.6|-3.0|
72577066|NCT01371747|144680804|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.5|||||TWO_SIDED||||||||Estimated values were based on summary statistics.|Each starting dose group was compared to its baseline.||||
72577067|NCT01371747|144680804|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-1.0|||||TWO_SIDED||||||||Estimated values were based on summary statistics.|Each starting dose group was compared to its baseline.||||
72577068|NCT01371747|144680804|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.96|||||TWO_SIDED||||||||Estimated values were based on summary statistics.|Each starting dose group was compared to its baseline.||||
72487578|NCT03740165|144503811|SUPERIORITY||Hazard Ratio (HR)|1.06||||0.7448|TWO_SIDED|95.0|0.89|1.27||One-sided p-value based on log-rank test stratified by debulking surgery (planned interval vs R0 following primary vs R1 following primary), bevacizumab use (Yes vs No), and PD-L1 CPS (\<10 vs ≥10)|Log Rank||Based on Cox regression model with Efron's method of tie handling; treatment as covariate stratified by debulking surgery (planned interval vs R0 following primary vs R1 following primary), bevacizumab use (Yes vs No), and PD-L1 CPS (\<10 vs ≥10)|||1.27|0.89|0.7448
72487579|NCT03740165|144503812|SUPERIORITY||Hazard Ratio (HR)|0.65||||0.0012|TWO_SIDED|95.0|0.5|0.86||One-sided p-value based on log-rank test stratified by debulking surgery (planned interval vs R0 following primary vs R1 following primary) and bevacizumab use (Yes vs No)|Log Rank||Based on Cox regression model with Efron's method of tie handling; treatment as covariate stratified by debulking surgery (planned interval vs R0 following primary vs R1 following primary) and bevacizumab use (Yes vs No)|||0.86|0.50|0.0012
72487580|NCT03740165|144503812|SUPERIORITY||Hazard Ratio (HR)|0.98||||0.4366|TWO_SIDED|95.0|0.75|1.27||One-sided p-value based on log-rank test stratified by debulking surgery (planned interval vs R0 following primary vs R1 following primary) and bevacizumab use (Yes vs No)|Log Rank||Based on Cox regression model with Efron's method of tie handling; treatment as covariate stratified by debulking surgery (planned interval vs R0 following primary vs R1 following primary) and bevacizumab use (Yes vs No)|||1.27|0.75|0.4366
72403179|NCT03441633|144312221|SUPERIORITY||Odds Ratio (OR)|1.51||||0|TWO_SIDED|95.0|1.29|1.76|||Chi-squared|||Warfarin vs. Apixaban in naive participants (Ex-smoker)||1.76|1.29|0.000
72487581|NCT03740165|144503813|SUPERIORITY||Hazard Ratio (HR)|0.74||||0.0008|TWO_SIDED|95.0|0.61|0.89||One-sided p-value based on log-rank test stratified by debulking surgery (planned interval vs R0 following primary vs R1 following primary), bevacizumab use (Yes vs No), and PD-L1 CPS (\<10 vs ≥10)|Log Rank||Based on Cox regression model with Efron's method of tie handling; treatment as covariate stratified by debulking surgery (planned interval vs R0 following primary vs R1 following primary), bevacizumab use (Yes vs No), and PD-L1 CPS (\<10 vs ≥10)|||0.89|0.61|0.0008
72487582|NCT03740165|144503813|SUPERIORITY||Hazard Ratio (HR)|1.05||||0.7174|TWO_SIDED|95.0|0.88|1.27||One-sided p-value based on log-rank test stratified by debulking surgery (planned interval vs R0 following primary vs R1 following primary), bevacizumab use (Yes vs No), and PD-L1 CPS (\<10 vs ≥10)|Log Rank||Based on Cox regression model with Efron's method of tie handling; treatment as covariate stratified by debulking surgery (planned interval vs R0 following primary vs R1 following primary), bevacizumab use (Yes vs No), and PD-L1 CPS (\<10 vs ≥10)|||1.27|0.88|0.7174
72487583|NCT03740165|144503814|SUPERIORITY||Hazard Ratio (HR)|0.78||||0.0228|TWO_SIDED|95.0|0.62|1.0||One-sided p-value based on log-rank test stratified by debulking surgery (planned interval vs R0 following primary vs R1 following primary) and bevacizumab use (Yes vs No)|Log Rank||Based on Cox regression model with Efron's method of tie handling; treatment as covariate stratified by debulking surgery (planned interval vs R0 following primary vs R1 following primary) and bevacizumab use (Yes vs No)|||1.00|0.62|0.0228
72487584|NCT03740165|144503814|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.3935|TWO_SIDED|95.0|0.77|1.22||One-sided p-value based on log-rank test stratified by debulking surgery (planned interval vs R0 following primary vs R1 following primary) and bevacizumab use (Yes vs No)|Log Rank||Based on Cox regression model with Efron's method of tie handling; treatment as covariate stratified by debulking surgery (planned interval vs R0 following primary vs R1 following primary) and bevacizumab use (Yes vs No)|||1.22|0.77|0.3935
72487585|NCT03740165|144503815|SUPERIORITY||Hazard Ratio (HR)|0.88||||0.0573|TWO_SIDED|95.0|0.74|1.03||One-sided p-value based on log-rank test stratified by debulking surgery (planned interval vs R0 following primary vs R1 following primary), bevacizumab use (Yes vs No), and PD-L1 CPS (\<10 vs ≥10)|Log Rank||Based on Cox regression model with Efron's method of tie handling; treatment as covariate stratified by debulking surgery (planned interval vs R0 following primary vs R1 following primary), bevacizumab use (Yes vs No), and PD-L1 CPS (\<10 vs ≥10)|||1.03|0.74|0.0573
72624160|NCT01892189|144778533|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2534|STANDARD_ERROR_OF_MEAN|0.17208||0.15|TWO_SIDED|95.0|-0.6032|0.0963|||ANOVA||Difference between least square means of TAK-063 30 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Left Paracingulte gyrus/BA32: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.0963|-0.6032|0.150
72624161|NCT01892189|144778533|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2821|STANDARD_ERROR_OF_MEAN|0.19038||0.148|TWO_SIDED|95.0|-0.669|0.1048|||ANOVA||Difference between least square means of TAK-063 3 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Right Paracingulte gyrus/BA3: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.1048|-0.6690|0.148
72624162|NCT01892189|144778533|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.048|STANDARD_ERROR_OF_MEAN|0.20543||0.817|TWO_SIDED|95.0|-0.4655|0.3695|||ANOVA||Difference between least square means of TAK-063 10 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Right Paracingulte gyrus/BA32: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.3695|-0.4655|0.817
72624163|NCT01892189|144778533|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3395|STANDARD_ERROR_OF_MEAN|0.19513||0.091|TWO_SIDED|95.0|-0.7361|0.057|||ANOVA||Difference between least square means of TAK-063 30 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Right Paracingulte gyrus/BA32: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.0570|-0.7361|0.091
72403180|NCT03441633|144312221|SUPERIORITY||Odds Ratio (OR)|1.72||||0|TWO_SIDED|95.0|1.54|1.93|||Chi-squared|||Warfarin vs. Apixaban in naive participants (Smoker)||1.93|1.54|0.000
72403181|NCT03441633|144312221|SUPERIORITY||Odds Ratio (OR)|0.91||||0.755|TWO_SIDED|95.0|0.72|1.17|||Chi-squared|||Warfarin vs. Apixaban in non-naive participants (Non-smoker)||1.17|0.72|0.755
72403182|NCT03441633|144312221|SUPERIORITY||Odds Ratio (OR)|1.25||||0.426|TWO_SIDED|95.0|0.78|1.95|||Chi-squared|||Warfarin vs. Apixaban in non-naive participants (Ex-smoker)||1.95|0.78|0.426
72403183|NCT03441633|144312221|SUPERIORITY||Odds Ratio (OR)|0.92||||0.93|TWO_SIDED|95.0|0.7|1.2|||Chi-squared|||Warfarin vs. Apixaban in naive participants (Smoker)||1.20|0.70|0.930
72514429|NCT01021852|144559658|SUPERIORITY_OR_OTHER||Difference in LS Means|-20.3|STANDARD_ERROR_OF_MEAN|4.38|<|0.001|TWO_SIDED|95.0|-29.0|-11.7|||Mixed Models Analysis|||"MK-6096 20 mg vs. Placebo at Night 1~A mixed effects model with terms for baseline value, geographic region (Japan vs. ex-Japan), gender, treatment, sequence, period, time, and treatment-by-time interaction and period-by-time interaction was used to estimate LS mean differences between MK-6096 and placebo at Night 1. 95% confidence interval estimate and p-value (based upon a normal approximation) were also computed from the LS mean differences and variability estimates from the model."||-11.7|-29.0|<0.001
72514430|NCT01021852|144559658|SUPERIORITY_OR_OTHER||Difference in LS Means|-8.9|STANDARD_ERROR_OF_MEAN|4.61||0.055|TWO_SIDED|95.0|-18.0|0.2|||Mixed Models Analysis|||"MK-6096 2.5 mg vs. Placebo at Week 4~A mixed effects model with terms for baseline value, geographic region (Japan vs. ex-Japan), gender, treatment, sequence, period, time, and treatment-by-time interaction and period-by-time interaction was used to estimate LS mean differences between MK-6096 and placebo at Week 4. 95% confidence interval estimate and p-value (based upon a normal approximation) were also computed from the LS mean differences and variability estimates from the model."||0.2|-18.0|0.055
72514431|NCT01021852|144559658|SUPERIORITY_OR_OTHER||Difference in LS Means|-8.7|STANDARD_ERROR_OF_MEAN|4.61||0.06|TWO_SIDED|95.0|-17.8|0.4|||Mixed Models Analysis|||"MK-6096 5 mg vs. Placebo at Week 4~A mixed effects model with terms for baseline value, geographic region (Japan vs. ex-Japan), gender, treatment, sequence, period, time, and treatment-by-time interaction and period-by-time interaction was used to estimate LS mean differences between MK-6096 and placebo at Week 4. 95% confidence interval estimate and p-value (based upon a normal approximation) were also computed from the LS mean differences and variability estimates from the model."||0.4|-17.8|0.060
72514432|NCT01021852|144559658|SUPERIORITY_OR_OTHER||Difference in LS Means|-19.5|STANDARD_ERROR_OF_MEAN|4.62|<|0.001|TWO_SIDED|95.0|-28.6|-10.4|||Mixed Models Analysis|||"MK-6096 10 mg vs. Placebo at Week 4~A mixed effects model with terms for baseline value, geographic region (Japan vs. ex-Japan), gender, treatment, sequence, period, time, and treatment-by-time interaction and period-by-time interaction was used to estimate LS mean differences between MK-6096 and placebo at Week 4. 95% confidence interval estimate and p-value (based upon a normal approximation) were also computed from the LS mean differences and variability estimates from the model."||-10.4|-28.6|<0.001
72514433|NCT01021852|144559658|SUPERIORITY_OR_OTHER||Difference in LS Means|-11.3|STANDARD_ERROR_OF_MEAN|4.63||0.015|TWO_SIDED|95.0|-20.5|-2.2|||Mixed Models Analysis|||"MK-6096 20 mg vs. Placebo at Week 4~A mixed effects model with terms for baseline value, geographic region (Japan vs. ex-Japan), gender, treatment, sequence, period, time, and treatment-by-time interaction and period-by-time interaction was used to estimate LS mean differences between MK-6096 and placebo at Week 4. 95% confidence interval estimate and p-value (based upon a normal approximation) were also computed from the LS mean differences and variability estimates from the model."||-2.2|-20.5|0.015
72514434|NCT01021852|144559659|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.6|||||TWO_SIDED|95.0|-9.5|12.2||||||Miettinen and Nurminen's method was used to calculate confidence intervals for between-treatment differences in the percentage of participants with events versus placebo.||12.2|-9.5|
72514435|NCT01021852|144559659|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|||||TWO_SIDED|95.0|-10.3|11.2||||||Miettinen and Nurminen's method was used to calculate confidence intervals for between-treatment differences in the percentage of participants with events versus placebo.||11.2|-10.3|
72514436|NCT01021852|144559659|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.5|||||TWO_SIDED|95.0|-4.2|18.3||||||Miettinen and Nurminen's method was used to calculate confidence intervals for between-treatment differences in the percentage of participants with events versus placebo.||18.3|-4.2|
72514437|NCT01021852|144559659|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.5|||||TWO_SIDED|95.0|-2.3|20.4||||||Miettinen and Nurminen's method was used to calculate confidence intervals for between-treatment differences in the percentage of participants with events versus placebo.||20.4|-2.3|
72567991|NCT02037165|144667472|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.53|STANDARD_ERROR_OF_MEAN|1.1242|||TWO_SIDED|95.0|-2.7|1.7|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 0:30h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||1.7|-2.7|
72403184|NCT03441633|144312222|SUPERIORITY||Odds Ratio (OR)|0.99||||0|TWO_SIDED|95.0|0.9|1.09|||Chi-squared|||Dabigatran vs. Apixaban in naive participants (No intake)||1.09|0.90|0.000
72514438|NCT01021852|144559660|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.8|||||TWO_SIDED|95.0|-1.0|10.2||||||Miettinen and Nurminen's method was used to calculate confidence intervals for between-treatment differences in the percentage of participants with events versus placebo.||10.2|-1.0|
72577069|NCT01371747|144680804|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-1.17|||||TWO_SIDED||||||||Estimated values were based on summary statistics.|Each starting dose group was compared to its baseline.||||
72577070|NCT01371747|144680805|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.36|||||TWO_SIDED||||||||Estimated values were based on summary statistics.|Each starting dose group was compared to its baseline.||||
72577071|NCT01371747|144680805|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.22|||||TWO_SIDED||||||||Estimated values were based on summary statistics.|Each starting dose group was compared to its baseline.||||
72403185|NCT03441633|144312222|SUPERIORITY||Odds Ratio (OR)|1.11||||0|TWO_SIDED|95.0|0.98|1.25|||Chi-squared|||Dabigatran vs. Apixaban in naive participants (Moderate intake)||1.25|0.98|0.000
72403186|NCT03441633|144312222|SUPERIORITY||Odds Ratio (OR)|1.52||||0.164|TWO_SIDED|95.0|0.94|2.45|||Chi-squared|||Dabigatran vs. Apixaban in naive participants (Risk consumption)||2.45|0.94|0.164
72577072|NCT01371747|144680805|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.3|||||TWO_SIDED||||||||Estimated values were based on summary statistics.|Each starting dose group was compared to its baseline.||||
72577073|NCT01371747|144680805|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.41|||||TWO_SIDED||||||||Estimated values were based on summary statistics.|Each starting dose group was compared to its baseline.||||
72403187|NCT03441633|144312222|SUPERIORITY||Odds Ratio (OR)|1.03||||0.826|TWO_SIDED|95.0|0.87|1.22|||Chi-squared|||Dabigatran vs. Apixaban in non-naive participants (No intake)||1.22|0.87|0.826
72403188|NCT03441633|144312222|SUPERIORITY||Odds Ratio (OR)|1.16||||0.19|TWO_SIDED|95.0|0.94|1.43|||Chi-squared|||Dabigatran vs. Apixaban in non-naive participants (Moderate intake)||1.43|0.94|0.190
72403189|NCT03441633|144312222|SUPERIORITY||Odds Ratio (OR)|0.58||||0.526|TWO_SIDED|95.0|0.18|1.57|||Chi-squared|||Dabigatran vs. Apixaban in non-naive participants (Risk consumption)||1.57|0.18|0.526
72403190|NCT03441633|144312222|SUPERIORITY||Odds Ratio (OR)|0.84||||0|TWO_SIDED|95.0|0.77|0.91|||Chi-squared|||Rivaroxaban vs. Apixaban in naive participants (No intake)||0.91|0.77|0.000
72403191|NCT03441633|144312222|SUPERIORITY||Odds Ratio (OR)|1.12||||0|TWO_SIDED|95.0|1.01|1.24|||Chi-squared|||Rivaroxaban vs. Apixaban in naive participants (Moderate intake)||1.24|1.01|0.000
72403192|NCT03441633|144312222|SUPERIORITY||Odds Ratio (OR)|1.17||||0.164|TWO_SIDED|95.0|0.76|1.83|||Chi-squared|||Rivaroxaban vs. Apixaban in naive participants (Risk consumption)||1.83|0.76|0.164
72403193|NCT03441633|144312222|SUPERIORITY||Odds Ratio (OR)|1.09||||0.826|TWO_SIDED|95.0|0.95|1.26|||Chi-squared|||Rivaroxaban vs. Apixaban in non-naive participants (No intake)||1.26|0.95|0.826
72403194|NCT03441633|144312222|SUPERIORITY||Odds Ratio (OR)|0.93||||0.19|TWO_SIDED|95.0|0.77|1.13|||Chi-squared|||Rivaroxaban vs. Apixaban in non-naive participants (Moderate intake)||1.13|0.77|0.190
72403195|NCT03441633|144312222|SUPERIORITY||Odds Ratio (OR)|1.26||||0.526|TWO_SIDED|95.0|0.62|2.65|||Chi-squared|||Rivaroxaban vs. Apixaban in non-naive participants (Risk consumption)||2.65|0.62|0.526
72487586|NCT03740165|144503815|SUPERIORITY||Hazard Ratio (HR)|1.05||||0.7234|TWO_SIDED|95.0|0.89|1.23||One-sided p-value based on log-rank test stratified by debulking surgery (planned interval vs R0 following primary vs R1 following primary), bevacizumab use (Yes vs No), and PD-L1 CPS (\<10 vs ≥10)|Log Rank||Based on Cox regression model with Efron's method of tie handling; treatment as covariate stratified by debulking surgery (planned interval vs R0 following primary vs R1 following primary), bevacizumab use (Yes vs No), and PD-L1 CPS (\<10 vs ≥10)|||1.23|0.89|0.7234
72403196|NCT03441633|144312222|SUPERIORITY||Odds Ratio (OR)|1.36||||0|TWO_SIDED|95.0|1.28|1.45|||Chi-squared|||Acenocoumarol vs. Apixaban in naive participants (No intake)||1.45|1.28|0.000
72487587|NCT03740165|144503816|SUPERIORITY||Difference in Least Squares Means (LSM)|0.26||||0.8481|TWO_SIDED|95.0|-2.44|2.97|||t-test, 2 sided||Based on cLDA model with scores as response variable; covariates for treatment by time interaction and stratification factors (debulking surgery \[planned interval vs R0 following primary vs R1 following primary\], bevacizumab use, and PD-L1 CPS)|||2.97|-2.44|0.8481
72487588|NCT03740165|144503816|SUPERIORITY||Difference in LS Means|-1.1||||0.4335|TWO_SIDED|95.0|-3.87|1.66|||t-test, 2 sided||Based on cLDA model with scores as response variable; covariates for treatment by time interaction and stratification factors (debulking surgery \[planned interval vs R0 following primary vs R1 following primary\], bevacizumab use, and PD-L1 CPS)|||1.66|-3.87|0.4335
72403197|NCT03441633|144312222|SUPERIORITY||Odds Ratio (OR)|1.24||||0|TWO_SIDED|95.0|1.14|1.35|||Chi-squared|||Acenocoumarol vs. Apixaban in naive participants (Moderate intake)||1.35|1.14|0.000
72403198|NCT03441633|144312222|SUPERIORITY||Odds Ratio (OR)|1.36||||0.164|TWO_SIDED|95.0|0.98|1.95|||Chi-squared|||Acenocoumarol vs. Apixaban in naive participants (Risk consumption)||1.95|0.98|0.164
72487589|NCT03740165|144503817|SUPERIORITY||Difference in Least Squares Means (LSM)|0.14||||0.9024|TWO_SIDED|95.0|-2.15|2.44|||t-test, 2 sided||Based on cLDA model with scores as response variable; covariates for treatment by time interaction and stratification factors (debulking surgery \[planned interval vs R0 following primary vs R1 following primary\], bevacizumab use, and PD-L1 CPS)|||2.44|-2.15|0.9024
72403199|NCT03441633|144312222|SUPERIORITY||Odds Ratio (OR)|1.04||||0.826|TWO_SIDED|95.0|0.76|1.41|||Chi-squared|||Acenocoumarol vs. Apixaban in non-naive participants (No intake)||1.41|0.76|0.826
72403200|NCT03441633|144312222|SUPERIORITY||Odds Ratio (OR)|1.22||||0.19|TWO_SIDED|95.0|0.82|1.76|||Chi-squared|||Acenocoumarol vs. Apixaban in non-naive participants (Moderate intake)||1.76|0.82|0.190
72403201|NCT03441633|144312222|SUPERIORITY||Odds Ratio (OR)|1.21||||0.526|TWO_SIDED|95.0|0.17|4.5|||Chi-squared|||Acenocoumarol vs. Apixaban in non-naive participants (Risk consumption)||4.50|0.17|0.526
72403202|NCT03441633|144312222|SUPERIORITY||Odds Ratio (OR)|1.28||||0|TWO_SIDED|95.0|1.16|1.42|||Chi-squared|||Warfarin vs. Apixaban in naive participants (No intake)||1.42|1.16|0.000
72403203|NCT03441633|144312222|SUPERIORITY||Odds Ratio (OR)|1.25||||0|TWO_SIDED|95.0|1.1|1.43|||Chi-squared|||Warfarin vs. Apixaban in naive participants (Moderate intake)||1.43|1.10|0.000
72403204|NCT03441633|144312222|SUPERIORITY||Odds Ratio (OR)|0.92||||0.164|TWO_SIDED|95.0|0.49|1.64|||Chi-squared|||Warfarin vs. Apixaban in naive participants (Risk consumption)||1.64|0.49|0.164
72403205|NCT03441633|144312222|SUPERIORITY||Odds Ratio (OR)|1.06||||0.826|TWO_SIDED|95.0|0.84|1.34|||Chi-squared|||Warfarin vs. Apixaban in non-naive participants (No intake)||1.34|0.84|0.826
72403206|NCT03441633|144312222|SUPERIORITY||Odds Ratio (OR)|0.91||||0.19|TWO_SIDED|95.0|0.66|1.23|||Chi-squared|||Warfarin vs. Apixaban in non-naive participants (Moderate intake)||1.23|0.66|0.190
72403207|NCT03441633|144312222|SUPERIORITY||Odds Ratio (OR)|0.64||||0.526|TWO_SIDED|95.0|0.09|2.36|||Chi-squared|||Warfarin vs. Apixaban in non-naive participants (Risk consumption)||2.36|0.09|0.526
72403208|NCT03441633|144312223|SUPERIORITY||Odds Ratio (OR)|1.36||||0|TWO_SIDED|95.0|1.2|1.53|||Chi-squared|||Dabigatran vs. Apixaban in naive participants (Quintile 1 - Urban area)||1.53|1.20|0.000
72403209|NCT03441633|144312223|SUPERIORITY||Odds Ratio (OR)|1.01||||0.014|TWO_SIDED|95.0|0.89|1.15|||Chi-squared|||Dabigatran vs. Apixaban in naive participants (Quintile 2 - Urban area)||1.15|0.89|0.014
72403210|NCT03441633|144312223|SUPERIORITY||Odds Ratio (OR)|0.87||||0|TWO_SIDED|95.0|0.77|0.99|||Chi-squared|||Dabigatran vs. Apixaban in naive participants (Quintile 3 - Urban area)||0.99|0.77|0.000
72403211|NCT03441633|144312223|SUPERIORITY||Odds Ratio (OR)|0.86||||0|TWO_SIDED|95.0|0.75|0.97|||Chi-squared|||Dabigatran vs. Apixaban in naive participants (Quintile 4 - Urban area)||0.97|0.75|0.000
72487590|NCT03740165|144503817|SUPERIORITY||Difference in Least Squares Means (LSM)|-0.08||||0.9478|TWO_SIDED|95.0|-2.47|2.31|||t-test, 2 sided||Based on cLDA model with scores as response variable; covariates for treatment by time interaction and stratification factors (debulking surgery \[planned interval vs R0 following primary vs R1 following primary\], bevacizumab use, and PD-L1 CPS)|||2.31|-2.47|0.9478
72403212|NCT03441633|144312223|SUPERIORITY||Odds Ratio (OR)|0.85||||0.013|TWO_SIDED|95.0|0.74|0.97|||Chi-squared|||Dabigatran vs. Apixaban in naive participants (Quintile 5 - Urban area)||0.97|0.74|0.013
72514439|NCT01021852|144559660|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9|||||TWO_SIDED|95.0|-3.6|4.8||||||Miettinen and Nurminen's method was used to calculate confidence intervals for between-treatment differences in the percentage of participants with events versus placebo.||4.8|-3.6|
72514440|NCT01021852|144559660|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3|||||TWO_SIDED|95.0|-2.7|6.6||||||Miettinen and Nurminen's method was used to calculate confidence intervals for between-treatment differences in the percentage of participants with events versus placebo.||6.6|-2.7|
72514441|NCT01021852|144559660|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.2|||||TWO_SIDED|95.0|-4.5|2.3||||||Miettinen and Nurminen's method was used to calculate confidence intervals for between-treatment differences in the percentage of participants with events versus placebo.||2.3|-4.5|
72514442|NCT03491553|144559664|OTHER||Percentage Difference|0.0|||||TWO_SIDED|95.0||||||||||||
72514443|NCT03491553|144559664|OTHER||Percentage Difference|0.0|||||TWO_SIDED|95.0||||||||||||
72514444|NCT03491553|144559664|OTHER||Percentage Difference|0.0|||||TWO_SIDED|95.0||||||||||||
72514445|NCT03491553|144559664|OTHER||Percentage Difference|10.0|||||TWO_SIDED|95.0|-47.2|47.1|||||The 2-sided 95% CI for the percentage difference by HBeAg status was constructed based on the standardized statistic and inverting two 1-sided tests.|||47.1|-47.2|
72514446|NCT03491553|144559665|OTHER||Percentage Difference|0.0|||||TWO_SIDED|95.0||||||||||||
72514447|NCT03491553|144559665|OTHER||Percentage Difference|0.0|||||TWO_SIDED|95.0||||||||||||
72514448|NCT03491553|144559665|OTHER||Percentage Difference|0.0|||||TWO_SIDED|95.0||||||||||||
72514449|NCT03491553|144559665|OTHER||Percentage Difference|0.0|||||TWO_SIDED|95.0||||||||||||
72514450|NCT03491553|144559666|OTHER||Percentage Difference|0.0|||||TWO_SIDED|95.0||||||||||||
72514451|NCT03491553|144559666|OTHER||Percentage Difference|0.0|||||TWO_SIDED|95.0||||||||||||
72514452|NCT03491553|144559666|OTHER||Percentage Difference|0.0|||||TWO_SIDED|95.0||||||||||||
72514453|NCT03491553|144559666|OTHER||Percentage Difference|0.0|||||TWO_SIDED|95.0||||||||||||
72514454|NCT03491553|144559667|OTHER||Percentage Difference|0.0|||||TWO_SIDED|95.0||||||||||||
72514455|NCT03491553|144559667|OTHER||Percentage Difference|0.0|||||TWO_SIDED|95.0||||||||||||
72514456|NCT03491553|144559667|OTHER||Percentage Difference|0.0|||||TWO_SIDED|95.0||||||||||||
72514457|NCT03491553|144559667|OTHER||Percentage Difference|0.0|||||TWO_SIDED|95.0||||||||||||
72514458|NCT03491553|144559668|OTHER||Percentage Difference|0.0|||||TWO_SIDED|95.0||||||||||||
72514459|NCT03491553|144559668|OTHER||Percentage Difference|0.0|||||TWO_SIDED|95.0||||||||||||
72514460|NCT03491553|144559668|OTHER||Percentage Difference|0.0|||||TWO_SIDED|95.0||||||||||||
72514461|NCT03491553|144559668|OTHER||Percentage Difference|10.0|||||TWO_SIDED|95.0|-47.2|47.1|||||The 2-sided 95% CI for the percentage difference by HBeAg status was constructed based on the standardized statistic and inverting two 1-sided tests.|||47.1|-47.2|
72514462|NCT00973921|144559691|SUPERIORITY_OR_OTHER||Proportion|1.0|||<|0.01|TWO_SIDED|95.0|0.86|1.0|||Wilson|||The 95% confidence Interval (CI) of the primary outcome has been calculated using the Wilson method of estimating the CI of a single proportion||1.0|0.86|<0.01
72514463|NCT00973921|144559692|SUPERIORITY_OR_OTHER||Correlation coefficient|0.74|||<|0.0001|||||||Bland Altman|||||||<0.0001
72514464|NCT00973921|144559694|SUPERIORITY_OR_OTHER||Correlation coefficient|0.5||||0.0034|||||||Bland-Altman|||||||0.0034
72514465|NCT02128763|144559723|SUPERIORITY|||||||0.4|TWO_SIDED|95.0||||P value refers to difference between group on change in overall OSDI score (Row 1).|Regression, Linear|||||||0.40
72514466|NCT02128763|144559724|SUPERIORITY|||||||0.09|TWO_SIDED|95.0|||||Regression, Linear|||||||0.09
72514467|NCT02128763|144559725|SUPERIORITY|||||||0.77|TWO_SIDED|95.0|||||Regression, Linear|Pos hoc application of the Benjamini-Hochberg adjustment||||||0.77
72514468|NCT02128763|144559726|SUPERIORITY|||||||0.95|TWO_SIDED|95.0|||||Regression, Linear|||||||0.95
72514469|NCT02128763|144559727|SUPERIORITY|||||||0.051|TWO_SIDED|95.0|||||Regression, Linear|||||||0.051
72514470|NCT02128763|144559728|SUPERIORITY||||||<|0.001|TWO_SIDED|95.0|||||Regression, Linear|||||||<0.001
72514471|NCT02128763|144559729|SUPERIORITY||||||<|0.001|TWO_SIDED|95.0|||||Regression, Linear|||||||<0.001
72514472|NCT02128763|144559730|SUPERIORITY|||||||0.4|TWO_SIDED|95.0|||||Regression, Linear|||||||0.40
72514473|NCT02128763|144559731|SUPERIORITY|||||||0.77|TWO_SIDED|95.0|||||Regression, Linear|||||||0.77
72514474|NCT02128763|144559732|SUPERIORITY|||||||0.95|TWO_SIDED|95.0|||||Regression, Linear|||||||0.95
72514475|NCT02128763|144559733|SUPERIORITY|||||||0.25|TWO_SIDED|95.0|||||Regression, Linear|||||||0.25
72514476|NCT02128763|144559734|SUPERIORITY|||||||0.61|TWO_SIDED|95.0|||||Regression, Linear|||||||0.61
72514477|NCT02128763|144559735|SUPERIORITY|||||||0.42|TWO_SIDED|95.0|||||Regression, Linear|||||||0.42
72514478|NCT02128763|144559736|SUPERIORITY|||||||0.6|TWO_SIDED|95.0|||||Chi-squared, Corrected|||||||0.60
72514479|NCT02128763|144559737|SUPERIORITY|||||||0.17|TWO_SIDED|95.0|||||Regression, Linear|||||||0.17
72514480|NCT02128763|144559738|SUPERIORITY|||||||0.02|TWO_SIDED|95.0|||||Regression, Linear|||||||0.02
72514481|NCT02128763|144559739|SUPERIORITY|||||||0.71|TWO_SIDED|95.0|||||Regression, Linear|||||||0.71
72514482|NCT02128763|144559740|SUPERIORITY|||||||0.66|TWO_SIDED|95.0|||||Regression, Linear|||||||0.66
72514483|NCT02128763|144559741|SUPERIORITY|||||||0.02|TWO_SIDED|95.0|||||Regression, Linear|||||||0.02
72514484|NCT02121756|144559782|OTHER|The sCD14 is measured in pg/ml and the median change is shown in pg/ml. the linear regression for the between arm comparison of baseline to week 12 change was performed using log10 transformed plasma sCD14||||||0.822|||||||Regression, Linear|||||||0.8220
72514485|NCT02121756|144559783|OTHER|The sCD163 is measured in ng/ml and the median change is shown in ng/ml. the linear regression for the between arm comparison of baseline to week 12 change was performed using log10 transformed plasma sCD163.||||||0.0869|||||||Regression, Linear|||||||0.0869
72487591|NCT03740165|144503818|SUPERIORITY||Hazard Ratio (HR)|0.92||||0.2644|TWO_SIDED|95.0|0.73|1.17||One-sided p-value based on log-rank test stratified by surgery (planned interval debulking versus R0 following primary debulking versus R1 following primary debulking), bevacizumab use (yes versus no), and PD-L1 status (CPS\<10 vs CPS≥10).|Log Rank||Based on Cox regression model with Efron's method of tie handling; treatment as covariate stratified by surgery (planned interval vs R0 following primary vs R1 following primary debulking), bevacizumab use (Yes vs No), PD-L1 status (CPS\<10 vs CPS≥10)|||1.17|0.73|0.2644
72487592|NCT03740165|144503818|SUPERIORITY||Hazard Ratio (HR)|0.9||||0.1953|TWO_SIDED|95.0|0.71|1.14||One-sided p-value based on log-rank test stratified by surgery (planned interval debulking versus R0 following primary debulking versus R1 following primary debulking), bevacizumab use (yes versus no), and PD-L1 status (CPS\<10 vs CPS≥10).|Log Rank||Based on Cox regression model with Efron's method of tie handling; treatment as covariate stratified by surgery (planned interval vs R0 following primary vs R1 following primary debulking), bevacizumab use (Yes vs No), PD-L1 status (CPS\<10 vs CPS≥10)|||1.14|0.71|0.1953
72487593|NCT03740165|144503819|SUPERIORITY||Hazard Ratio (HR)|1.01||||0.5188|TWO_SIDED|95.0|0.77|1.3||One-sided p-value based on log-rank test stratified by debulking surgery (planned interval vs R0 following primary vs R1 following primary), bevacizumab use (Yes vs No), and PD-L1 CPS (\<10 vs ≥10)|Log Rank||Based on Cox regression model with Efron's method of tie handling; treatment as covariate stratified by debulking surgery (planned interval vs R0 following primary vs R1 following primary), bevacizumab use (Yes vs No), and PD-L1 CPS (\<10 vs ≥10)|||1.30|0.77|0.5188
72487594|NCT03740165|144503819|SUPERIORITY||Hazard Ratio (HR)|1.0||||0.5091|TWO_SIDED|95.0|0.77|1.3||One-sided p-value based on log-rank test stratified by debulking surgery (planned interval vs R0 following primary vs R1 following primary), bevacizumab use (Yes vs No), and PD-L1 CPS (\<10 vs ≥10)|Log Rank||Based on Cox regression model with Efron's method of tie handling; treatment as covariate stratified by debulking surgery (planned interval vs R0 following primary vs R1 following primary), bevacizumab use (Yes vs No), and PD-L1 CPS (\<10 vs ≥10)|||1.30|0.77|0.5091
72487595|NCT03740165|144503820|SUPERIORITY||Hazard Ratio (HR)|0.69|||<|0.0001|TWO_SIDED|95.0|0.59|0.8||One-sided p-value based on log-rank test stratified by debulking surgery (planned interval vs R0 following primary vs R1 following primary), bevacizumab use (Yes vs No), and PD-L1 CPS (\<10 vs ≥10)|Log Rank||Based on Cox regression model with Efron's method of tie handling; treatment as covariate stratified by debulking surgery (planned interval vs R0 following primary vs R1 following primary), bevacizumab use (Yes vs No), and PD-L1 CPS (\<10 vs ≥10)|||0.80|0.59|<0.0001
72487596|NCT03740165|144503820|SUPERIORITY||Hazard Ratio (HR)|0.92||||0.1206|TWO_SIDED|95.0|0.79|1.06||One-sided p-value based on log-rank test stratified by debulking surgery (planned interval vs R0 following primary vs R1 following primary), bevacizumab use (Yes vs No), and PD-L1 CPS (\<10 vs ≥10)|Log Rank||Based on Cox regression model with Efron's method of tie handling; treatment as covariate stratified by debulking surgery (planned interval vs R0 following primary vs R1 following primary), bevacizumab use (Yes vs No), and PD-L1 CPS (\<10 vs ≥10)|||1.06|0.79|0.1206
72487597|NCT03740165|144503821|SUPERIORITY||Hazard Ratio (HR)|0.89||||0.0853||95.0|0.76|1.05||One-sided p-value based on log-rank test stratified by debulking surgery (planned interval vs R0 following primary vs R1 following primary), bevacizumab use (Yes vs No), and PD-L1 CPS (\<10 vs ≥10)|Log Rank||Based on Cox regression model with Efron's method of tie handling; treatment as covariate stratified by debulking surgery (planned interval vs R0 following primary vs R1 following primary), bevacizumab use (Yes vs No), and PD-L1 CPS (\<10 vs ≥10)|||1.05|0.76|0.0853
72487598|NCT03740165|144503821|SUPERIORITY||Hazard Ratio (HR)|1.05||||0.7165||95.0|0.89|1.23||One-sided p-value based on log-rank test stratified by debulking surgery (planned interval vs R0 following primary vs R1 following primary), bevacizumab use (Yes vs No), and PD-L1 CPS (\<10 vs ≥10)|Log Rank||Based on Cox regression model with Efron's method of tie handling; treatment as covariate stratified by debulking surgery (planned interval vs R0 following primary vs R1 following primary), bevacizumab use (Yes vs No), and PD-L1 CPS (\<10 vs ≥10)|||1.23|0.89|0.7165
72487599|NCT03740165|144503822|SUPERIORITY||Hazard Ratio (HR)|0.88||||0.0442||95.0|0.76|1.02||One-sided p-value based on log-rank test stratified by debulking surgery (planned interval vs R0 following primary vs R1 following primary), bevacizumab use (Yes vs No), and PD-L1 CPS (\<10 vs ≥10)|Log Rank||Based on Cox regression model with Efron's method of tie handling; treatment as covariate stratified by debulking surgery (planned interval vs R0 following primary vs R1 following primary), bevacizumab use (Yes vs No), and PD-L1 CPS (\<10 vs ≥10)|||1.02|0.76|0.0442
72487600|NCT03740165|144503822|SUPERIORITY||Hazard Ratio (HR)|1.14||||0.9565||95.0|0.98|1.31||One-sided p-value based on log-rank test stratified by debulking surgery (planned interval vs R0 following primary vs R1 following primary), bevacizumab use (Yes vs No), and PD-L1 CPS (\<10 vs ≥10)|Log Rank||Based on Cox regression model with Efron's method of tie handling; treatment as covariate stratified by debulking surgery (planned interval vs R0 following primary vs R1 following primary), bevacizumab use (Yes vs No), and PD-L1 CPS (\<10 vs ≥10)|||1.31|0.98|0.9565
72487601|NCT03740165|144503823|SUPERIORITY||Difference in Percentage|3.7||||0.0318|TWO_SIDED|95.0|-0.3|7.3||One-sided p-value for testing. H0: difference in % = 0 versus H1: difference in % \> 0.|t-test, 1 sided||Based on Miettinen \& Nurminen method stratified by bevacizumab use (Yes vs No) and PD-L1 CPS (\<10 vs ≥10)|||7.3|-0.3|0.0318
72487602|NCT02044133|144503826|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
72487603|NCT05318937|144503827|SUPERIORITY||Difference in LS Means|0.0|STANDARD_ERROR_OF_MEAN|2.07||0.9934|TWO_SIDED|95.0|-4.13|4.09||The p-value was obtained using a MMRM model which included treatment, visit, treatment-by-visit interaction as categorical covariates, and WAIS-IV at baseline as continuous covariates.|MMRM||Difference was calculated as SAGE-718 - placebo.|||4.09|-4.13|0.9934
72487604|NCT05314517|144503835|OTHER||Stratified Common Risk Difference|14.1||||0.1244|TWO_SIDED|90.0|-1.0|29.2|||Cochran-Mantel-Haenszel|||||29.2|-1.0|0.1244
72403213|NCT03441633|144312223|SUPERIORITY||Odds Ratio (OR)|1.05||||0.157|TWO_SIDED|95.0|0.84|1.31|||Chi-squared|||Dabigatran vs. Apixaban in non-naive participants (Quintile 1 - Urban area)||1.31|0.84|0.157
72403214|NCT03441633|144312223|SUPERIORITY||Odds Ratio (OR)|1.03||||0.124|TWO_SIDED|95.0|0.82|1.29|||Chi-squared|||Dabigatran vs. Apixaban in non-naive participants (Quintile 2 - Urban area)||1.29|0.82|0.124
72403215|NCT03441633|144312223|SUPERIORITY||Odds Ratio (OR)|0.77||||0.062|TWO_SIDED|95.0|0.61|0.96|||Chi-squared|||Dabigatran vs. Apixaban in non-naive participants (Quintile 3 - Urban area)||0.96|0.61|0.062
72487605|NCT04490018|144503865|NON_INFERIORITY|The two-sided 95 percent (%) confidence interval (CI) was calculated based on the Wilson score method without continuity correction. The non-inferiority was demonstrated if the lower limit of the 95% CI of the percentage difference between compared groups was greater than (\>) -10%.|Difference in Percentage|4.98|||||TWO_SIDED|95.0|0.06|10.36||||||Serogroup A||10.36|0.06|
72487606|NCT04490018|144503865|NON_INFERIORITY|The two-sided 95% CI was calculated based on the Wilson score method without continuity correction. The non-inferiority was demonstrated if the lower limit of the 95% CI of the percentage difference between compared groups was greater \> -10%.|Difference in Percentage|4.97|||||TWO_SIDED|95.0|1.58|9.5||||||Serogroup C||9.50|1.58|
72514486|NCT02121756|144559784|OTHER|The IL-6 is measured in pg/ml and the median change is shown in pg/ml. the linear regression for the between arm comparison of baseline to week 12 change was performed using log10 transformed plasma IL-6.||||||0.5027|||||||Regression, Linear|||||||0.5027
72514487|NCT02121756|144559785|OTHER|||||||0.4548|||||||Mixed Models Analysis|||||||0.4548
72514488|NCT02121756|144559787|OTHER|||||||0.7556|||||||Mixed Models Analysis|||||||0.7556
72514489|NCT02121756|144559788|OTHER|||||||0.2075|||||||Mixed Models Analysis|||||||0.2075
72514490|NCT02121756|144559789|OTHER|||||||0.0315|||||||Mixed Models Analysis|||||||0.0315
72514491|NCT02121756|144559790|OTHER|||||||0.7376|||||||Mixed Models Analysis|||||||0.7376
72514492|NCT02121756|144559791|OTHER|||||||0.2343|||||||Mixed Models Analysis|||||||0.2343
72514493|NCT02121756|144559792|OTHER|||||||0.7598|||||||Mixed Models Analysis|||||||0.7598
72514494|NCT02121756|144559793|OTHER|||||||0.983|||||||Mixed Models Analysis|||||||0.9830
72514495|NCT02121756|144559794|OTHER|||||||0.3317|||||||Mixed Models Analysis|||||||0.3317
72514496|NCT02121756|144559795|OTHER|||||||0.6121|||||||Mixed Models Analysis|||||||0.6121
72514497|NCT02121756|144559796|OTHER|||||||0.562|||||||Mixed Models Analysis|||||||0.5620
72514498|NCT02365584|144559803|SUPERIORITY|"The assumptions required for the analysis of covariance (ANCOVA) were to be tested as follows:~* The equality of variances was to verified using the Levene's test. If it was significant AUC values were to be properly transformed.~* The linear relationship of AUC with the basal total score within treatment group was to be tested by a regression analysis.~* The parallelism of the regression lines between groups and the slope non zero value with the appropriate F tests."|Adjusted LS Mean Difference|-11.0|STANDARD_ERROR_OF_MEAN|17.7|=|0.5396|TWO_SIDED|95.0|-47.0|25.0|||ANCOVA|||Analysis of covariance (ANCOVA), where the AUC was the dependent and the independent was the baseline ESAS total score.||25|-47|=0.5396
72514499|NCT02193815|144559830|SUPERIORITY_OR_OTHER||Adjusted Mean Ratio|93.2|STANDARD_ERROR_OF_MEAN|0.075||0.3465|TWO_SIDED|95.0|80.43|107.99|||Mixed Models Analysis|||||107.99|80.43|0.3465
72514500|NCT02193815|144559831|SUPERIORITY_OR_OTHER||Adjusted Mean|165.88|STANDARD_ERROR_OF_MEAN|0.075|<|0.0001|TWO_SIDED|95.0|143.12|192.25|||Mixed Models Analysis|||||192.25|143.12|<0.0001
72514501|NCT02193815|144559832|SUPERIORITY_OR_OTHER||Adjusted Mean|65.42|STANDARD_ERROR_OF_MEAN|0.075|<|0.0001|TWO_SIDED|95.0|56.46|75.81|||Mixed Models Analysis|||||75.81|56.46|<0.0001
72514502|NCT02193815|144559833|SUPERIORITY_OR_OTHER||Adjusted Mean|93.04|STANDARD_ERROR_OF_MEAN|0.075||0.3349|TWO_SIDED|95.0|80.3|107.81|||Mixed Models Analysis|||||107.81|80.30|0.3349
72514503|NCT02193815|144559833|SUPERIORITY_OR_OTHER||Adjusted Mean|149.56|STANDARD_ERROR_OF_MEAN|0.075|<|0.0001|TWO_SIDED|95.0|129.04|173.34|||Mixed Models Analysis|||||173.34|129.04|<0.0001
72514504|NCT02193815|144559833|SUPERIORITY_OR_OTHER||Adjusted Mean|106.51|STANDARD_ERROR_OF_MEAN|0.075||0.3991|TWO_SIDED|95.0|91.92|123.41|||Mixed Models Analysis|||||123.41|91.92|0.3991
72514505|NCT02193815|144559833|SUPERIORITY_OR_OTHER||Adjusted Mean|71.94|STANDARD_ERROR_OF_MEAN|0.075|<|0.0001|TWO_SIDED|95.0|62.08|83.36|||Mixed Models Analysis|||||83.36|62.08|<0.0001
72514506|NCT02193815|144559834|SUPERIORITY_OR_OTHER||Adjusted Mean|96.04|STANDARD_ERROR_OF_MEAN|0.127||0.7529|TWO_SIDED|95.0|74.0|124.64|||Mixed Models Analysis|||||124.64|74.00|0.7529
72514507|NCT02193815|144559834|SUPERIORITY_OR_OTHER||Adjusted Mean|125.62|STANDARD_ERROR_OF_MEAN|0.147||0.1318|TWO_SIDED|95.0|92.96|169.75|||Mixed Models Analysis|||||169.75|92.96|0.1318
72514508|NCT02193815|144559834|SUPERIORITY_OR_OTHER||Adjusted Mean|103.35|STANDARD_ERROR_OF_MEAN|0.129||0.8009|TWO_SIDED|95.0|79.3|134.68|||Mixed Models Analysis|||||134.68|79.30|0.8009
72514509|NCT02193815|144559834|SUPERIORITY_OR_OTHER||Adjusted Mean|81.09|STANDARD_ERROR_OF_MEAN|0.124||0.1012|TWO_SIDED|95.0|62.94|104.47|||Mixed Models Analysis|||||104.47|62.94|0.1012
72514510|NCT00064350|144559842|SUPERIORITY_OR_OTHER_LEGACY|||||||0.005||95.0|||||Fisher Exact|||Compare the proportion of patients maintaining stable disease or objective response at 2 months after randomization between the two arms.||||0.005
72514511|NCT00064350|144559843|SUPERIORITY_OR_OTHER_LEGACY|||||||0.014||95.0|||||Log Rank|||Compare PFS between the Sorafenib arm and the placebo arm||||0.014
72514512|NCT00064350|144559844|SUPERIORITY_OR_OTHER_LEGACY|||||||0.12||95.0|||||Log Rank|||Compare OS between the Sorafenib arm and the placebo arm||||0.12
72514513|NCT00838916|144559846|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.11|||||TWO_SIDED|95.0|-0.04|0.27|||ANCOVA|||||0.27|-0.04|
72514514|NCT00838916|144559846|NON_INFERIORITY_OR_EQUIVALENCE|To test whether the difference of least square means (albiglutide - insulin glargine) is equal to the pre-specified non-inferiority margin of 0.3%||||||0.0086||||||p-value is for non-inferiority testing of albiglutide versus insulin glargine|t-test, 1 sided|||||||0.0086
72514515|NCT00838916|144559846|SUPERIORITY_OR_OTHER|||||||0.1463||||||p-value is for superiority testing of albiglutide versus insulin glargine|t-test, 2 sided|The p-value is from a two-sided t-test to test whether the difference of least square means (albiglutide - insulin glargine) is equal to zero.||||||0.1463
72577074|NCT01371747|144680805|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.39|||||TWO_SIDED||||||||Estimated values were based on summary statistics.|Each starting dose group was compared to its baseline.||||
72577075|NCT01371747|144680805|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.58|||||TWO_SIDED||||||||Estimated values were based on summary statistics.|Each starting dose group was compared to its baseline.||||
72403216|NCT03441633|144312223|SUPERIORITY||Odds Ratio (OR)|0.98||||0.079|TWO_SIDED|95.0|0.78|1.22|||Chi-squared|||Dabigatran vs. Apixaban in non-naive participants (Quintile 4 - Urban area)||1.22|0.78|0.079
72403217|NCT03441633|144312223|SUPERIORITY||Odds Ratio (OR)|1.09||||0.14|TWO_SIDED|95.0|0.86|1.38|||Chi-squared|||Dabigatran vs. Apixaban in non-naive participants (Quintile 5 - Urban area)||1.38|0.86|0.140
72487607|NCT04490018|144503865|NON_INFERIORITY|The two-sided 95% CI was calculated based on the Wilson score method without continuity correction. The non-inferiority was demonstrated if the lower limit of the 95% CI of the percentage difference between compared groups was greater \> -10%.|Difference in Percentage|1.24|||||TWO_SIDED|95.0|-1.28|4.42||||||Serogroup W||4.42|-1.28|
72487608|NCT04490018|144503865|NON_INFERIORITY|The two-sided 95% CI was calculated based on the Wilson score method without continuity correction. The non-inferiority was demonstrated if the lower limit of the 95% CI of the percentage difference between compared groups was greater \> -10%.|Difference in Percentage|1.24|||||TWO_SIDED|95.0|-1.88|4.77||||||Serogroup Y||4.77|-1.88|
72487609|NCT04714073|144503893|OTHER||Ratio of geometric means (%)|218.81|||||TWO_SIDED|90.0|194.06|246.72|||||"The estimated parameter was the adjusted geometric mean ratio (%): BI 706321 + Itraconazole (Test Treatment(T))/BI 706321 alone (Reference Treatment (R)).~Intra-individual geometric coefficient of variation (gCV) \[%\] = 18.1."|The statistical model used for the analysis of the primary PK endpoints was an analysis of variance (ANOVA) model on the logarithmic scale. The PK endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model. This model included effects accounting for the following sources of variation: 'subjects' and 'treatment'. The effect 'subject' was considered as random, whereas 'treatment' was considered as fixed.||246.72|194.06|
72487610|NCT04714073|144503894|OTHER||Ratio of geometric means (%)|156.29|||||TWO_SIDED|90.0|135.04|180.89|||||"The estimated parameter was the adjusted geometric mean ratio (%): BI 706321 + Itraconazole (Test Treatment(T))/BI 706321 alone (Reference Treatment (R)).~Intra-individual geometric coefficient of variation (gCV) \[%\] = 22.1."|The statistical model used for the analysis of the primary PK endpoints was an analysis of variance (ANOVA) model on the logarithmic scale. The PK endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model. This model included effects accounting for the following sources of variation: 'subjects' and 'treatment'. The effect 'subject' was considered as random, whereas 'treatment' was considered as fixed.||180.89|135.04|
72487611|NCT04714073|144503895|OTHER||Ratio of geometric means (%)|223.12|||||TWO_SIDED|90.0|198.61|250.66|||||"The estimated parameter was the adjusted geometric mean ratio (%): BI 706321 + Itraconazole (Test Treatment(T))/BI 706321 alone (Reference Treatment (R)).~Intra-individual geometric coefficient of variation (gCV) \[%\] = 17.5."|The statistical model used for the analysis of the primary PK endpoints was an analysis of variance (ANOVA) model on the logarithmic scale. The PK endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model. This model included effects accounting for the following sources of variation: 'subjects' and 'treatment'. The effect 'subject' was considered as random, whereas 'treatment' was considered as fixed.||250.66|198.61|
72487612|NCT00282295|144503896|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority objective was demonstrated if the lower limit was greater than (\>) the pre-defined limit of -10%.|Difference|2.18|||||TWO_SIDED|95.0|0.79|4.17||||||The non-inferiority of Boostrix® vaccine co-administered with Menactra™ vaccine compared to Boostrix® vaccine administered alone at Month 0 with respect to the percentage of subjects with anti-diphtheria toxoid (anti-D) antibody concentrations equal to or greater than (≥) 1.0 IU/mL one month after vaccination.||4.17|0.79|
72487613|NCT00282295|144503896|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority objective was demonstrated if the lower limit was greater than (\>) the pre-defined limit of -10%.|Difference|0.02|||||TWO_SIDED|95.0|-1.4|1.48||||||Non-inferiority of Boostrix® vaccine co-administered with Menactra™ vaccine compared toBoostrix® vaccine administered alone at Month 0 with respect to the percentage of subjects with anti-tetanus toxoid (anti-T) antibody concentrations equal to or greater than (≥) 1.0 IU/mL one month after vaccination.||1.48|-1.4|
72487614|NCT00282295|144503897|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority objective was demonstrated if the lower limit was greater than (\>) the pre-defined limit of 0.67|Adjusted GMC ratio|0.93|||||TWO_SIDED|95.0|0.84|1.03||||||Non-inferiority of Boostrix® vaccine co-administered with Menactra™ vaccine compared to Boostrix® vaccine administered alone at Month 0 with respect to anti-pertussis toxoid (anti-PT) geometric mean antibody concentrations (GMCs) one month after vaccination.||1.03|0.84|
72487615|NCT00282295|144503897|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority objective was demonstrated if the lower limit was \> the pre-defined limit of 0.67|Adjusted GMC ratio|0.76|||||TWO_SIDED|95.0|0.69|0.84||||||Non-inferiority of Boostrix® vaccine co-administered with Menactra™ vaccine compared to Boostrix® vaccine administered alone at Month 0 with respect to anti-filamentous hemagglutinin (anti-FHA) GMCs one month after vaccination.||0.84|0.69|
72487616|NCT00282295|144503897|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority objective was demonstrated if the lower limit was \> the pre-defined limit of 0.67|Adjusted GMC ratio|0.63|||||TWO_SIDED|95.0|0.54|0.72||||||To demonstrate the non-inferiority of Boostrix® vaccine co-administered with Menactra™ vaccine compared to Boostrix® vaccine administered alone at Month 0 with respect to anti-pertactin (anti-PRN) GMCs one month after vaccination.||0.72|0.54|
72487617|NCT00282295|144503898|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority objective was demonstrated if the lower limit was \> the pre-defined limit of -10%.|Difference in booster response rate|-4.38|||||TWO_SIDED|95.0|-9.91|1.15||||||Non-inferiority of Boostrix® vaccine co-administered with Menactra™ vaccine compared to Boostrix® vaccine administered alone at Month 0 with respect to a booster response to PT one month after vaccination.||1.15|-9.91|
72577076|NCT01371747|144680806|SUPERIORITY_OR_OTHER_LEGACY||Percentage of Participants|100.0|||||TWO_SIDED|95.0|94.3|100.0|||||2-sided 95% exact binomial CI|||100.0|94.3|
72577077|NCT01371747|144680806|SUPERIORITY_OR_OTHER_LEGACY||Percentage of Participants|100.0|||||TWO_SIDED|95.0|94.5|100.0|||||2-sided 95% exact binomial CI|||100|94.5|
72577078|NCT01371747|144680806|SUPERIORITY_OR_OTHER_LEGACY||Percentage of Participants|98.4|||||TWO_SIDED|95.0|91.6|100.0|||||2-sided 95% exact binomial CI|||100|91.6|
72403218|NCT03441633|144312223|SUPERIORITY||Odds Ratio (OR)|1.31||||0|TWO_SIDED|95.0|1.17|1.45|||Chi-squared|||Rivaroxaban vs. Apixaban in naive participants (Quintile 1 - Urban area)||1.45|1.17|0.000
72403219|NCT03441633|144312223|SUPERIORITY||Odds Ratio (OR)|0.97||||0.014|TWO_SIDED|95.0|0.87|1.09|||Chi-squared|||Rivaroxaban vs. Apixaban in naive participants (Quintile 2 - Urban area)||1.09|0.87|0.014
72403220|NCT03441633|144312223|SUPERIORITY||Odds Ratio (OR)|1.01||||0|TWO_SIDED|95.0|0.91|1.12|||Chi-squared|||Rivaroxaban vs. Apixaban in naive participants (Quintile 3 - Urban area)||1.12|0.91|0.000
72403221|NCT03441633|144312223|SUPERIORITY||Odds Ratio (OR)|0.94||||0|TWO_SIDED|95.0|0.85|1.05|||Chi-squared|||Rivaroxaban vs. Apixaban in naive participants (Quintile 4 - Urban area)||1.05|0.85|0.000
72403222|NCT03441633|144312223|SUPERIORITY||Odds Ratio (OR)|0.83||||0.013|TWO_SIDED|95.0|0.74|0.93|||Chi-squared|||Rivaroxaban vs. Apixaban in naive participants (Quintile 5 - Urban area)||0.93|0.74|0.013
72487618|NCT00282295|144503898|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority objective was demonstrated if the lower limit was \> the pre-defined limit of -10%.|Difference in booster response rate|-3.39|||||TWO_SIDED|95.0|-7.03|0.15||||||Non-inferiority of Boostrix® vaccine co-administered with Menactra™ vaccine compared to Boostrix® vaccine administered alone at Month 0 with respect to a booster response to FHA one month after vaccination.||0.15|-7.03|
72487619|NCT00282295|144503898|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority objective was demonstrated if the lower limit was \> the pre-defined limit of -10%.|Difference in booster response rate|-1.96|||||TWO_SIDED|95.0|-5.25|-1.25||||||To demonstrate the non-inferiority of Boostrix® vaccine co-administered with Menactra™ vaccine compared to Boostrix® vaccine administered alone at Month 0 with respect to a booster response to PRN one month after vaccination.||-1.25|-5.25|
72487620|NCT00282295|144503899|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority objective was demonstrated if the lower limit was greater than the pre-defined limit of -10%.|Difference in vaccine response rate|-0.21|||||TWO_SIDED|95.0|-4.85|4.43||||||Non-inferiority of Menactra™ vaccine co-administered with Boostrix® vaccinecompared to Menactra™ vaccine administered alone at Month 0 with respect to a vaccine responseto meningococcal serogroup A one month after vaccination.||4.43|-4.85|
72487621|NCT00282295|144503899|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority objective was demonstrated if the lower limit was greater than the pre-defined limit of -10%.|Difference in vaccine response rate|1.69|||||TWO_SIDED|95.0|-1.69|5.16||||||Non-inferiority of Menactra™ vaccine co-administered with Boostrix® vaccine compared to Menactra™ vaccine administered alone at Month 0 with respect to a vaccine responseto meningococcal serogroup C one month after vaccination.||5.16|-1.69|
72487622|NCT00282295|144503899|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority objective was demonstrated if the lower limit was greater than the pre-defined limit of -10%.|Difference in vaccine response rate|1.82||||||95.0|-2.58|6.25||||||Non-inferiority of Menactra™ vaccine co-administered with Boostrix® vaccine compared to Menactra™ vaccine administered alone at Month 0 with respect to a vaccine response to meningococcal serogroup Y one month after vaccination.||6.25|-2.58|
72487623|NCT00282295|144503899|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority objective was demonstrated if the lower limit was greater than the pre-defined limit of -10%.|Difference in vaccine response rate|3.56|||||TWO_SIDED|95.0|0.96|6.45||||||Non-inferiority of Menactra™ vaccine co-administered with Boostrix® vaccine compared to Menactra™ vaccine administered alone at Month 0 with respect to a vaccine response to meningococcal serogroup W-135 one month after vaccination||6.45|0.96|
72487624|NCT00121108|144503926|SUPERIORITY||Relative risk|0.13|||<|0.001|TWO_SIDED|95.0|0.08|0.21|||Fisher Exact|||||0.21|0.08|<0.001
72487625|NCT01380379|144503937|SUPERIORITY_OR_OTHER||||||<|0.01|||||||t-test, 2 sided|Single group comparison pre-post change score, compared to a value of 0 (no change)||||||<.01
72487626|NCT01380379|144503938|SUPERIORITY_OR_OTHER||||||<|0.04|||||||t-test, 2 sided|||||||<.04
72487627|NCT01180478|144503978|SUPERIORITY_OR_OTHER|||||||0.585|||||||Log Rank|||The expected recurrence rate in the WL-assisted TURBT group was 35%.14 To detect a clinically relevant difference in recurrence detection rates ≥10% at a 5% significance level and a power of 80%, the required sample size per treatment was calculated to be 329 patients (658 patients in total).||||0.585
72487628|NCT01180478|144503979|SUPERIORITY_OR_OTHER|||||||0.742|||||||Chi-squared|||||||0.742
72487629|NCT01180478|144503980|SUPERIORITY_OR_OTHER|||||||0.17|||||||Fisher Exact|The analysis was performed by using the Fisher exact test, because the criteria for using the Chi square test were not met.||The statistical analyses refers to comparison of the different 8 categories (one variable) mentioned of the Clavien grading of perioperative complications between Narrow Band Imaging and White Light Trans Urethral Resection.||||0.170
72487630|NCT01180478|144503981|SUPERIORITY_OR_OTHER|||||||0.311|||||||Chi-squared|||Comparison of the numbers in 'Bleeding' between NBI and WL||||0.311
72487631|NCT01180478|144503981|SUPERIORITY_OR_OTHER|||||||0.666|||||||Chi-squared|||Comparison of the numbers in 'Fever' between NBI and WL||||0.666
72487632|NCT01180478|144503981|SUPERIORITY_OR_OTHER|||||||0.569|||||||Chi-squared|||Comparison in the number of 'UTI' between NBI and WL||||0.569
72487633|NCT01180478|144503981|SUPERIORITY_OR_OTHER|||||||0.111|||||||Chi-squared|||Comparison in the number of 'Bladder cramps' between NBI and WL||||0.111
72487634|NCT01180478|144503981|SUPERIORITY_OR_OTHER|||||||||||||||||Comparison in the number of 'DVT' between NBI and WL|Non of the participants/patients had DVT. Therefore, the p-value is not available|||
72487635|NCT01180478|144503981|SUPERIORITY_OR_OTHER|||||||0.5|||||||Fisher Exact|||Comparison in the number of 'CVA/TIA' between NBI and WL||||0.500
72487636|NCT01180478|144503981|SUPERIORITY_OR_OTHER|||||||||||||||||Comparison in the number of 'Lung embolism' between NBI and WL|Non of the participants/patients had a lung embolism. Therefore, no p-value was available|||
72403223|NCT03441633|144312223|SUPERIORITY||Odds Ratio (OR)|0.92||||0.157|TWO_SIDED|95.0|0.76|1.13|||Chi-squared|||Rivaroxaban vs. Apixaban in non-naive participants (Quintile 1 - Urban area)||1.13|0.76|0.157
72403224|NCT03441633|144312223|SUPERIORITY||Odds Ratio (OR)|0.98||||0.124|TWO_SIDED|95.0|0.81|1.2|||Chi-squared|||Rivaroxaban vs. Apixaban in non-naive participants (Quintile 2 - Urban area)||1.20|0.81|0.124
72487637|NCT01180478|144503981|SUPERIORITY_OR_OTHER|||||||0.5|||||||Fisher Exact|||Comparison in the number of 'Sepsis' between NBI and WL||||0.500
72487638|NCT01180478|144503981|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||Comparison in the number of 'Acute Abdomen' between NBI and WL||||1.000
72487639|NCT01180478|144503981|SUPERIORITY_OR_OTHER|||||||0.17|||||||Chi-squared|||Comparison in the number of 'Other perioperative complication' between NBI and WL||||0.170
72487640|NCT01180478|144503982|SUPERIORITY_OR_OTHER|||||||0.553|TWO_SIDED||||||Chi-squared|||||||0.553
72577079|NCT01371747|144680806|SUPERIORITY_OR_OTHER_LEGACY||Percentage of Participants|91.7|||||TWO_SIDED|95.0|73.0|99.0|||||2-sided 95% exact binomial CI|||99|73|
72577080|NCT01371747|144680806|SUPERIORITY_OR_OTHER_LEGACY||Percentage of Participants|95.8|||||TWO_SIDED|95.0|78.9|99.9|||||2-sided 95% exact binomial CI|||99.9|78.9|
72567992|NCT02037165|144667472|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.99|STANDARD_ERROR_OF_MEAN|1.124|||TWO_SIDED|95.0|-3.2|1.2|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 1:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||1.2|-3.2|
72567993|NCT02037165|144667472|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.45|STANDARD_ERROR_OF_MEAN|1.1238|||TWO_SIDED|95.0|-3.7|0.8|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 2:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||0.8|-3.7|
72567994|NCT02037165|144667472|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.06|STANDARD_ERROR_OF_MEAN|1.1236|||TWO_SIDED|95.0|-3.3|1.2|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 3:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||1.2|-3.3|
72567995|NCT02037165|144667472|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.1|STANDARD_ERROR_OF_MEAN|1.1236|||TWO_SIDED|95.0|-2.3|2.1|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 4:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||2.1|-2.3|
72567996|NCT02037165|144667472|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.08|STANDARD_ERROR_OF_MEAN|1.1236|||TWO_SIDED|95.0|-2.3|2.1|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 5:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||2.1|-2.3|
72567997|NCT02037165|144667472|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.5|STANDARD_ERROR_OF_MEAN|1.1238|||TWO_SIDED|95.0|-3.7|0.7|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 6:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||0.7|-3.7|
72567998|NCT02037165|144667472|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.05|STANDARD_ERROR_OF_MEAN|1.124|||TWO_SIDED|95.0|-3.3|1.2|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 22:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||1.2|-3.3|
72567999|NCT02037165|144667472|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.07|STANDARD_ERROR_OF_MEAN|1.1242|||TWO_SIDED|95.0|-2.3|2.1|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 24:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||2.1|-2.3|
72568000|NCT02037165|144667472|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.35|STANDARD_ERROR_OF_MEAN|1.0986|||TWO_SIDED|95.0|-2.5|1.8|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 0:30h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||1.8|-2.5|
72403225|NCT03441633|144312223|SUPERIORITY||Odds Ratio (OR)|0.79||||0.062|TWO_SIDED|95.0|0.65|0.96|||Chi-squared|||Rivaroxaban vs. Apixaban in non-naive participants (Quintile 3 - Urban area)||0.96|0.65|0.062
72403226|NCT03441633|144312223|SUPERIORITY||Odds Ratio (OR)|1.23||||0.079|TWO_SIDED|95.0|1.02|1.48|||Chi-squared|||Rivaroxaban vs. Apixaban in non-naive participants (Quintile 4 - Urban area)||1.48|1.02|0.079
72403227|NCT03441633|144312223|SUPERIORITY||Odds Ratio (OR)|1.21||||0.14|TWO_SIDED|95.0|0.99|1.49|||Chi-squared|||Rivaroxaban vs. Apixaban in non-naive participants (Quintile 5 - Urban area)||1.49|0.99|0.140
72514516|NCT02164513|144559875|SUPERIORITY||Rate ratio|0.75|||<|0.001|TWO_SIDED|95.0|0.7|0.81||The adjusted p-values should be compared against a reference level of 0.05 in order to infer statistical significance for either of the comparisons.|Negative binomial model||Covariates of treatment group, sex, exacerbation history (\<=1, \>=2 moderate/severe), smoking status (Screening), geographical region and post-bronchodilator percent predicted Forced expiratory volume in 1 second (FEV1) (Screening) were used.|||0.81|0.70|<0.001
72514517|NCT02164513|144559875|SUPERIORITY||Rate ratio|0.85|||<|0.001|TWO_SIDED|95.0|0.8|0.9||The adjusted p-values should be compared against a reference level of 0.05 in order to infer statistical significance for either of the comparisons|Negative binomial model||Covariates of treatment group, sex, exacerbation history (\<=1, \>=2 moderate/severe), smoking status (Screening), geographical region and post-bronchodilator percent predicted Forced expiratory volume in 1 second (FEV1) (Screening) were used.|||0.90|0.80|<0.001
72514518|NCT02164513|144559876|SUPERIORITY||Mean Difference (Net)|0.097|STANDARD_ERROR_OF_MEAN|0.0061|<|0.001|TWO_SIDED|95.0|0.085|0.109||The adjusted p-value at Week 52 should be compared against a reference level of 0.05 in order to infer statistical significance for the comparison of FF/UMEC/VI versus (vs) FF/VI at Week 52.|Mixed Models Repeated Measures|||||0.109|0.085|<0.001
72514519|NCT02164513|144559877|SUPERIORITY||Mean Difference (Net)|-1.8|STANDARD_ERROR_OF_MEAN|0.34|<|0.001|TWO_SIDED|95.0|-2.4|-1.1||The adjusted p-value at Week 52 should be compared against a reference level of 0.05 in order to infer statistical significance for the comparison of FF/UMEC/VI vs FF/VI at Week 52.|Mixed Models Repeated Measures|||||-1.1|-2.4|<0.001
72514520|NCT02164513|144559878|SUPERIORITY||Hazard Ratio (HR)|0.85|||<|0.001|TWO_SIDED|95.0|0.8|0.91||The adjusted p-values should be compared against a reference level of 0.05 in order to infer statistical significance for either of the comparisons.|Cox proportional hazard model|||||0.91|0.80|<0.001
72514521|NCT02164513|144559878|SUPERIORITY||Hazard Ratio (HR)|0.84|||<|0.001|TWO_SIDED|95.0|0.78|0.91|||Cox proportional hazard model|||||0.91|0.78|<0.001
72514522|NCT02164513|144559879|SUPERIORITY||Rate ratio|0.68|||<|0.001|TWO_SIDED|95.0|0.62|0.75|||Negative binomial Model|||||0.75|0.62|<0.001
72514523|NCT02164513|144559880|SUPERIORITY||Hazard Ratio (HR)|0.77|||<|0.001|TWO_SIDED|95.0|0.7|0.85|||Cox proportional hazard model|||||0.85|0.70|<0.001
72514524|NCT02164513|144559881|SUPERIORITY||Rate Ratio|0.87||||0.064|TWO_SIDED|95.0|0.76|1.01|||Negative binomial model|||||1.01|0.76|0.064
72514525|NCT02164513|144559881|SUPERIORITY||Rate ratio|0.66|||<|0.001|TWO_SIDED|95.0|0.56|0.78|||Negative binomial model|||||0.78|0.56|<0.001
72514526|NCT01179347|144559910|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.64|STANDARD_ERROR_OF_MEAN|0.97||0.092||95.0|-0.27|3.55||Two-sided p-value.|Mixed Models Analysis|Restricted maximum likelihood (REML)-based MMRM. Adjusted for treatment, visit, treatment-by-visit, age group, baseline and baseline-by-visit.|Tio R5 qd minus Placebo.|Hierarchical testing procedure was applied for both co-primary endpoints to maintain the overall alpha level. If and only if statistical superiority of the Tio R5 qd compared to Placebo in FEV1 AUC0-4h was demonstrated at the 1 sided alpha level of 0.025, confirmatory comparison in the second co-primary endpoint, at the same alpha level of 0.025 could be done .||3.55|-0.27|0.092
72514527|NCT01179347|144559911|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.4|STANDARD_ERROR_OF_MEAN|0.97||0.15||95.0|-0.5|3.3||Two-sided p-value.|Mixed Models Analysis|REML-based MMRM. Adjusted for treatment, visit, treatment-by-visit, age group, baseline and baseline-by-visit.|Tio R5 qd minus Placebo.|Hierarchical testing for co-primary endpoints, confirmatory only if previous hypotheses had been successful,||3.30|-0.50|0.15
72514528|NCT01179347|144559912|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.09|STANDARD_ERROR_OF_MEAN|0.9||0.23||95.0|-0.68|2.86||Two-sided p-value.|Mixed Models Analysis|REML-based MMRM. Adjusted for treatment, visit, treatment-by-visit, age group, baseline and baseline-by-visit.|Tio R5 qd minus Placebo.|||2.86|-0.68|0.23
72514529|NCT01179347|144559913|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.2|STANDARD_ERROR_OF_MEAN|0.93||0.19||95.0|-0.62|3.02||Two-sided p-value.|Mixed Models Analysis|REML-based MMRM. Adjusted for treatment, visit, treatment-by-visit, age group, baseline and baseline-by-visit.|Tio R5 qd minus Placebo.|||3.02|-0.62|0.19
72577081|NCT01371747|144680806|SUPERIORITY_OR_OTHER_LEGACY||Percentage of Participants|95.5|||||TWO_SIDED|95.0|77.2|99.9|||||2-sided 95% exact binomial CI|||99.9|77.2|
72403228|NCT03441633|144312223|SUPERIORITY||Odds Ratio (OR)|0.96||||0|TWO_SIDED|95.0|0.88|1.05|||Chi-squared|||Acenocoumarol vs. Apixaban in naive participants (Quintile 1 - Urban area)||1.05|0.88|0.000
72403229|NCT03441633|144312223|SUPERIORITY||Odds Ratio (OR)|0.91||||0.014|TWO_SIDED|95.0|0.84|0.99|||Chi-squared|||Acenocoumarol vs. Apixaban in naive participants (Quintile 2 - Urban area)||0.99|0.84|0.014
72403230|NCT03441633|144312223|SUPERIORITY||Odds Ratio (OR)|0.83||||0|TWO_SIDED|95.0|0.76|0.9|||Chi-squared|||Acenocoumarol vs. Apixaban in naive participants (Quintile 3 - Urban area)||0.90|0.76|0.000
72514530|NCT01179347|144559914|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.86|STANDARD_ERROR_OF_MEAN|1.76||0.62||95.0|-2.59|4.32||Two-sided p-value.|Mixed Models Analysis|REML-based MMRM. Adjusted for treatment, visit, treatment-by-visit, age group, baseline and baseline-by-visit.|Tio R5 qd minus Placebo.|||4.32|-2.59|0.62
72514531|NCT01179347|144559915|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.092||||0.84||95.0|0.453|2.633||Two-sided p-value.|Regression, Logistic|Adjusted for treatment, age group, baseline weight and baseline FEV1 percent predicted.|Tio R5 qd versus Placebo.|||2.633|0.453|0.84
72514532|NCT03353753|144559933|SUPERIORITY||Hazard Ratio, log|0.15|||<|0.0001|TWO_SIDED|95.0|0.09|0.25||Two-sided P-value|Log Rank|Strata: prior lines of therapy (3 versus ≥4); ECOG (0 versus 1 or 2)|Ripretinib: Placebo; based on stratified Cox Proportional Hazards Regression Model using randomization stratification factors \[prior lines of therapy (3 versus ≥4); ECOG (0 versus 1 or 2)\]|||0.25|0.09|<0.0001
72514533|NCT03353753|144559934|SUPERIORITY|||||||0.0504||||||Two-sided P-value|Fisher Exact|||||||0.0504
72514534|NCT03353753|144559936|SUPERIORITY||Hazard Ratio (HR)|0.36||||0.0004|TWO_SIDED|95.0|0.21|0.62||Not evaluated for statistical significance as a result of the sequential testing procedure for the secondary endpoints of ORR and OS.|Log Rank|Strata: prior lines of therapy (3 versus ≥4); ECOG (0 versus 1 or 2)|Ripretinib: Placebo; based on stratified Cox Proportional Hazards Regression Model using randomization stratification factors \[prior lines of therapy (3 versus ≥4); ECOG (0 versus 1 or 2)\]|||0.62|0.21|0.0004
72514535|NCT03353753|144559937|SUPERIORITY|||||||0.001||||||Not evaluated for statistical significance as a result of the sequential testing procedure for the secondary endpoints of ORR, OS, and QOL.|ANCOVA|Factors: prior lines of therapy (3 versus ≥4); ECOG (0 versus 1 or 2)||||||0.001
72514536|NCT03353753|144559938|SUPERIORITY|||||||0.004||||||Not evaluated for statistical significance as a result of the sequential testing procedure for the secondary endpoints of ORR, OS, and QOL.|ANCOVA|Factors: prior lines of therapy (3 versus ≥4); ECOG (0 versus 1 or 2)||||||0.004
72514537|NCT03353753|144559939|SUPERIORITY|||||||0.004|||||||t-test, 2 sided|||||||0.004
72514538|NCT00205699|144559949|SUPERIORITY||||||<|0.0001||||||The p value refers to the time by treatment condition interaction. The a priori threshold for statistical significance in this planned primary test was p\<0.05.|Mixed Models Analysis|||Primary analysis for change in DEXA % fat used a likelihood-based mixed-effects model using time (0, 6 and 12 weeks) and medication group as independent variables, with Toeplitz covariance structure specified, based on Bayesian information criteria (BIC). The null hypotheses were that there was no difference in the outcome over time (main effect of time) and that there were no differences between groups in the change over time (time by treatment condition).||||<0.0001
72514539|NCT00205699|144559950|SUPERIORITY|||||||0.07|||||||ANCOVA|||||||0.07
72514540|NCT00205699|144559951|SUPERIORITY|||||||0.27|||||||ANCOVA|||||||0.27
72514541|NCT00205699|144559952|SUPERIORITY|||||||0.17|||||||ANCOVA|||||||0.17
72514542|NCT00205699|144559953|SUPERIORITY|||||||0.29|||||||ANCOVA|||||||0.29
72514543|NCT00205699|144559954|SUPERIORITY||||||<|0.003|||||||ANCOVA|||Repeated measures ANCOVA was used to test for the main effect of time on the outcome, and to test for a time by treatment condition interaction that would indicate differences between groups in change over time in the primary outcome. The null hypotheses were that there was no difference in the outcome over time (main effect of time) and that there were no differences between groups in the change over time (time by treatment condition).||||<0.003
72514544|NCT00205699|144559954|SUPERIORITY|||||||0.003||||||Bonferroni correction for multiple comparisons was applied (p\<0.05/4 = 0.0125).|Contrast|Contrasts based on the ANCOVA-derived time by treatment condition interaction.||||||0.003
72514545|NCT00205699|144559954|SUPERIORITY|||||||0.002||||||Bonferroni correction for multiple comparisons was applied (p\<0.05/4 = 0.0125).|ANCOVA|Contrasts based on the ANCOVA-derived time by treatment condition interaction.||||||0.002
72514546|NCT02093234|144559959|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Chi-squared|||||||<0.0001
72403231|NCT03441633|144312223|SUPERIORITY||Odds Ratio (OR)|0.84||||0|TWO_SIDED|95.0|0.77|0.91|||Chi-squared|||Acenocoumarol vs. Apixaban in naive participants (Quintile 4 - Urban area)||0.91|0.77|0.000
72514547|NCT02093234|144559960|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Chi-squared|||||||<0.0001
72514548|NCT02093234|144559961|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Chi-squared|||||||<0.0001
72514549|NCT02093234|144559962|SUPERIORITY_OR_OTHER|||||||0.02|||||||Wilcoxon signed rank|||||||0.02
72403232|NCT03441633|144312223|SUPERIORITY||Odds Ratio (OR)|0.92||||0.013|TWO_SIDED|95.0|0.85|1.0|||Chi-squared|||Acenocoumarol vs. Apixaban in naive participants (Quintile 5 - Urban area)||1.00|0.85|0.013
72514550|NCT01170702|144559972|NON_INFERIORITY|The non inferiority margin is clinically important reduction in 24 hour hydromorphone consumption of 25%, 37.5% and 50% absolute reduction, compared with control.|Median Difference (Final Values)|1.25|STANDARD_DEVIATION|0.05||0.05|TWO_SIDED|0.975|1.25|1.25|||Kruskal-Wallis|||||1.25|1.25|.05
72514551|NCT01677507|144559980|OTHER||Mean Difference (Final Values)|2.8||||0.0001|TWO_SIDED|95.0|2.4|3.3|||t-test, 2 sided|Actually these are 2 sided paired t-tests.||Right Eye treated vs. untreated||3.3|2.4|0.0001
72514552|NCT01677507|144559980|OTHER||Mean Difference (Final Values)|2.8||||0.0001|TWO_SIDED|95.0|2.5|3.2|||t-test, 2 sided|paired t-test, 2 sided||Left Eye treated vs. untreated||3.2|2.5|0.0001
72514553|NCT01677507|144559980|OTHER||Mean Difference (Final Values)|3.0||||0.0001|TWO_SIDED|95.0|2.5|3.4|||t-test, 2 sided|paired t-test, 2 sided||Right Eye treated vs. untreated||3.4|2.5|0.0001
72514554|NCT01677507|144559980|OTHER||Mean Difference (Final Values)|2.9||||0.0001|TWO_SIDED|95.0|2.5|3.3|||t-test, 2 sided|paired t-test, 2 sided||Left Eye, treated vs. untreated||3.3|2.5|0.0001
72514555|NCT01677507|144559981|OTHER||Median Difference (Final Values)|1.1||||0.0001|TWO_SIDED|95.0|0.9|1.3|||t-test, 2 sided|paired t test, 2 sided||Right Eye treated to untreated||1.3|0.9|0.0001
72403233|NCT03441633|144312223|SUPERIORITY||Odds Ratio (OR)|1.03||||0.157|TWO_SIDED|95.0|0.68|1.54|||Chi-squared|||Acenocoumarol vs. Apixaban in non-naive participants (Quintile 1 - Urban area)||1.54|0.68|0.157
72403234|NCT03441633|144312223|SUPERIORITY||Odds Ratio (OR)|0.84||||0.124|TWO_SIDED|95.0|0.53|1.29|||Chi-squared|||Acenocoumarol vs. Apixaban in non-naive participants (Quintile 2 - Urban area)||1.29|0.53|0.124
72403235|NCT03441633|144312223|SUPERIORITY||Odds Ratio (OR)|0.75||||0.062|TWO_SIDED|95.0|0.48|1.13|||Chi-squared|||Acenocoumarol vs. Apixaban in non-naive participants (Quintile 3 - Urban area)||1.13|0.48|0.062
72403236|NCT03441633|144312223|SUPERIORITY||Odds Ratio (OR)|0.88||||0.079|TWO_SIDED|95.0|0.57|1.33|||Chi-squared|||Acenocoumarol vs. Apixaban in non-naive participants (Quintile 4 - Urban area)||1.33|0.57|0.079
72403237|NCT03441633|144312223|SUPERIORITY||Odds Ratio (OR)|1.05||||0.14|TWO_SIDED|95.0|0.67|1.59|||Chi-squared|||Acenocoumarol vs. Apixaban in non-naive participants (Quintile 5 - Urban area)||1.59|0.67|0.140
72403238|NCT03441633|144312223|SUPERIORITY||Odds Ratio (OR)|0.39||||0|TWO_SIDED|95.0|0.32|0.47|||Chi-squared|||Warfarin vs. Apixaban in naive participants (Quintile 1 - Urban area)||0.47|0.32|0.000
72403239|NCT03441633|144312223|SUPERIORITY||Odds Ratio (OR)|0.84||||0.014|TWO_SIDED|95.0|0.73|0.97|||Chi-squared|||Warfarin vs. Apixaban in naive participants (Quintile 2 - Urban area)||0.97|0.73|0.014
72403240|NCT03441633|144312223|SUPERIORITY||Odds Ratio (OR)|1.7||||0|TWO_SIDED|95.0|1.51|1.91|||Chi-squared|||Warfarin vs. Apixaban in naive participants (Quintile 3 - Urban area)||1.91|1.51|0.000
72403241|NCT03441633|144312223|SUPERIORITY||Odds Ratio (OR)|1.86||||0|TWO_SIDED|95.0|1.65|2.1|||Chi-squared|||Warfarin vs. Apixaban in naive participants (Quintile 4 - Urban area)||2.10|1.65|0.000
72403242|NCT03441633|144312223|SUPERIORITY||Odds Ratio (OR)|0.94||||0.013|TWO_SIDED|95.0|0.82|1.08|||Chi-squared|||Warfarin vs. Apixaban in naive participants (Quintile 5 - Urban area)||1.08|0.82|0.013
72487641|NCT00054704|144503983|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.828|STANDARD_ERROR_OF_MEAN|3.182||0.086|TWO_SIDED|95.0|-12.59|0.934||A linear mixed model included drug, visit and their interaction as fixed factors. Subject was a random factor. The test here is for the main effect of drug.|Mixed Models Analysis|Baseline score was a covariate. Restricted maximum likelihood estimates were used with a compound symmetry covariance structure.||The primary intent of this study was to compare the efficacy of riluzole to placebo in the treatment of overall depressive symptomatology of bipolar disorder subjects who were acutely depressed. Data from 8 riluzole and 11 placebo participants were analyzed due to missing data for one riluzole patient.||0.934|-12.590|.086
72487642|NCT02187471|144504029|SUPERIORITY||Mean Difference (Final Values)|-0.14|STANDARD_ERROR_OF_MEAN|0.191||0.4601|TWO_SIDED|95.0|-0.52|0.23|||Difference of means|||||0.23|-0.52|0.4601
72487643|NCT02187471|144504029|SUPERIORITY||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.19||0.035|TWO_SIDED|95.0|-0.77|-0.03|||Difference of means|||||-0.03|-0.77|0.0350
72487644|NCT02187471|144504029|SUPERIORITY||Mean Difference (Final Values)|-0.74|STANDARD_ERROR_OF_MEAN|0.191||0.0001|TWO_SIDED|95.0|-1.12|-0.37|||Difference of means|||||-0.37|-1.12|0.0001
72487645|NCT02187471|144504029|SUPERIORITY||Mean Difference (Final Values)|0.6|STANDARD_ERROR_OF_MEAN|0.193||0.0019|TWO_SIDED|95.0|0.22|0.98|||Difference of means|||||0.98|0.22|0.0019
72487646|NCT02187471|144504029|SUPERIORITY||Mean Difference (Final Values)|0.34|STANDARD_ERROR_OF_MEAN|0.192||0.0761|TWO_SIDED|95.0|-0.04|0.72|||Difference of means|||||0.72|-0.04|0.0761
72487647|NCT02187471|144504031|SUPERIORITY||Mean Difference (Final Values)|-1.59|STANDARD_ERROR_OF_MEAN|1.67||0.3407|TWO_SIDED|95.0|-4.86|1.68|||Difference of means|||||1.68|-4.86|0.3407
72514556|NCT01677507|144559981|OTHER||Median Difference (Final Values)|0.9||||0.0001|TWO_SIDED|95.0|0.7|1.1|||t-test, 2 sided|paired t test, 2 sided||Left Eye, treated vs. untreated||1.1|0.7|0.0001
72514557|NCT01677507|144559981|OTHER||Mean Difference (Final Values)|0.01||||0.94|TWO_SIDED|95.0|-0.2|0.2|||t-test, 2 sided|paired t-test||Right Eye, treated vs. untreated||0.2|-0.2|0.94
72403243|NCT03441633|144312223|SUPERIORITY||Odds Ratio (OR)|1.35||||0.157|TWO_SIDED|95.0|1.0|1.8|||Chi-squared|||Warfarin vs. Apixaban in non-naive participants (Quintile 1 - Urban area)||1.80|1.00|0.157
72403244|NCT03441633|144312223|SUPERIORITY||Odds Ratio (OR)|1.41||||0.124|TWO_SIDED|95.0|1.04|1.88|||Chi-squared|||Warfarin vs. Apixaban in non-naive participants (Quintile 2 - Urban area)||1.88|1.04|0.124
72403245|NCT03441633|144312223|SUPERIORITY||Odds Ratio (OR)|0.76||||0.062|TWO_SIDED|95.0|0.55|1.05|||Chi-squared|||Warfarin vs. Apixaban in non-naive participants (Quintile 3 - Urban area)||1.05|0.55|0.062
72403246|NCT03441633|144312223|SUPERIORITY||Odds Ratio (OR)|0.92||||0.079|TWO_SIDED|95.0|0.67|1.26|||Chi-squared|||Warfarin vs. Apixaban in non-naive participants (Quintile 4 - Urban area)||1.26|0.67|0.079
72403247|NCT03441633|144312223|SUPERIORITY||Odds Ratio (OR)|0.81||||0.14|TWO_SIDED|95.0|0.56|1.15|||Chi-squared|||Warfarin vs. Apixaban in non-naive participants (Quintile 5 - Urban area)||1.15|0.56|0.140
72403248|NCT03441633|144312224|SUPERIORITY||Odds Ratio (OR)|1.07||||0|TWO_SIDED|95.0|0.91|1.25|||Chi-squared|||Dabigatran vs. Apixaban in naive participants (18.5 - 25 kg per m\^2 Normal)||1.25|0.91|0.000
72403249|NCT03441633|144312224|SUPERIORITY||Odds Ratio (OR)|1.38||||0.202|TWO_SIDED|95.0|0.58|3.23|||Chi-squared|||Dabigatran vs. Apixaban in naive participants (\<18.5 kg per m\^2 Underweight)||3.23|0.58|0.202
72403250|NCT03441633|144312224|SUPERIORITY||Odds Ratio (OR)|0.98||||0|TWO_SIDED|95.0|0.88|1.09|||Chi-squared|||Dabigatran vs. Apixaban in naive participants (25 - 30 kg per m\^2 Overweight)||1.09|0.88|0.000
72403251|NCT03441633|144312224|SUPERIORITY||Odds Ratio (OR)|0.84||||0.003|TWO_SIDED|95.0|0.76|0.93|||Chi-squared|||Dabigatran vs. Apixaban in naive participants (\>30 kg per m\^2 Obese)||0.93|0.76|0.003
72403252|NCT03441633|144312224|SUPERIORITY||Odds Ratio (OR)|0.82||||0.083|TWO_SIDED|95.0|0.66|1.03|||Chi-squared|||Dabigatran vs. Apixaban in non-naive participants (18.5 - 25 kg per m\^2 Normal)||1.03|0.66|0.083
72487648|NCT02187471|144504031|SUPERIORITY||Mean Difference (Final Values)|-5.42|STANDARD_ERROR_OF_MEAN|1.669||0.0012|TWO_SIDED|95.0|-8.69|-2.15|||Difference of means|||||-2.15|-8.69|0.0012
72487649|NCT02187471|144504031|SUPERIORITY||Mean Difference (Final Values)|-4.39|STANDARD_ERROR_OF_MEAN|1.665||0.0083|TWO_SIDED|95.0|-7.66|-1.13|||Difference of means|||||-1.13|-7.66|0.0083
72487650|NCT02187471|144504031|SUPERIORITY||Mean Difference (Final Values)|2.8|STANDARD_ERROR_OF_MEAN|1.677||0.0946|TWO_SIDED|95.0|-0.48|6.09|||Difference of means|||||6.09|-0.48|0.0946
72514558|NCT01677507|144559981|OTHER||Mean Difference (Final Values)|0.05||||0.54|TWO_SIDED|95.0|-0.1|0.2|||t-test, 2 sided|paired t-test, 2 sided||Left Eye, treated vs. untreated||0.2|-0.1|0.54
72514559|NCT01677507|144559982|OTHER||Mean Difference (Final Values)|0.4||||0.04|TWO_SIDED|95.0|0.01|0.7|||t-test, 2 sided|paired t-test, 2 sided||Right Eye, treated vs. untreated||0.7|0.01|0.04
72568001|NCT02037165|144667472|SUPERIORITY_OR_OTHER||Adjusted mean difference|-2.31|STANDARD_ERROR_OF_MEAN|1.0985|||TWO_SIDED|95.0|-4.5|-0.2|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 1:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||-0.2|-4.5|
72568002|NCT02037165|144667472|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.39|STANDARD_ERROR_OF_MEAN|1.0984|||TWO_SIDED|95.0|-3.6|0.8|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 2:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||0.8|-3.6|
72568003|NCT02037165|144667472|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.38|STANDARD_ERROR_OF_MEAN|1.0984|||TWO_SIDED|95.0|-3.5|0.8|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 3:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||0.8|-3.5|
72568004|NCT02037165|144667472|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.15|STANDARD_ERROR_OF_MEAN|1.0983|||TWO_SIDED|95.0|-3.3|1.0|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 4:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||1.0|-3.3|
72568005|NCT02037165|144667472|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.63|STANDARD_ERROR_OF_MEAN|1.0984|||TWO_SIDED|95.0|-2.8|1.5|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 5:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||1.5|-2.8|
72568006|NCT02037165|144667472|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.53|STANDARD_ERROR_OF_MEAN|1.0984|||TWO_SIDED|95.0|-3.7|0.6|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 6:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||0.6|-3.7|
72403253|NCT03441633|144312224|SUPERIORITY||Odds Ratio (OR)|1.99||||0.011|TWO_SIDED|95.0|0.68|6.18|||Chi-squared|||Dabigatran vs. Apixaban in non-naive participants (\<18.5 kg per m\^2 Underweight)||6.18|0.68|0.011
72403254|NCT03441633|144312224|SUPERIORITY||Odds Ratio (OR)|0.89||||0.227|TWO_SIDED|95.0|0.75|1.06|||Chi-squared|||Dabigatran vs. Apixaban in non-naive participants (25 - 30 kg per m\^2 Overweight)||1.06|0.75|0.227
72568007|NCT02037165|144667472|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.96|STANDARD_ERROR_OF_MEAN|1.0985|||TWO_SIDED|95.0|-3.1|1.2|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 22:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||1.2|-3.1|
72577082|NCT01371747|144680807|SUPERIORITY_OR_OTHER_LEGACY||Percentage of Participants|95.2|||||TWO_SIDED|95.0|86.7|99.0|||||2-sided 95% exact binomial CI|||99.0|86.7|
72577083|NCT01371747|144680807|SUPERIORITY_OR_OTHER_LEGACY||Percentage of Participants|90.8|||||TWO_SIDED|95.0|81.0|96.5|||||2-sided 95% exact binomial CI|||96.5|81.0|
72577084|NCT01371747|144680807|SUPERIORITY_OR_OTHER_LEGACY||Percentage of Participants|81.3|||||TWO_SIDED|95.0|69.5|89.9|||||2-sided 95% exact binomial CI|||89.9|69.5|
72577085|NCT01371747|144680807|SUPERIORITY_OR_OTHER_LEGACY||Percentage of Participants|79.2|||||TWO_SIDED|95.0|57.8|92.9|||||2-sided 95% exact binomial CI|||92.9|57.8|
72577086|NCT01371747|144680807|SUPERIORITY_OR_OTHER_LEGACY||Percentage of Participants|91.7|||||TWO_SIDED|95.0|73.0|99.0|||||2-sided 95% exact binomial CI|||99|73|
72577087|NCT01371747|144680807|SUPERIORITY_OR_OTHER_LEGACY||Percentage of Participants|77.3|||||TWO_SIDED|95.0|54.6|92.2|||||2-sided 95% exact binomial CI|||92.2|54.6|
72403255|NCT03441633|144312224|SUPERIORITY||Odds Ratio (OR)|1.23||||0|TWO_SIDED|95.0|1.03|1.47|||Chi-squared|||Dabigatran vs. Apixaban in non-naive participants (\>30 kg per m\^2 Obese)||1.47|1.03|0.000
72487651|NCT02187471|144504031|SUPERIORITY||Mean Difference (Final Values)|-1.03|STANDARD_ERROR_OF_MEAN|1.669||0.5384|TWO_SIDED|95.0|-4.3|2.24|||Difference of means|||||2.24|-4.30|0.5384
72487652|NCT02187471|144504033|SUPERIORITY||Difference in least squares means|-0.9|STANDARD_ERROR_OF_MEAN|0.3||0.003|TWO_SIDED|95.0|-1.5|-0.3|||ANCOVA|||||-0.3|-1.5|0.0030
72487653|NCT02187471|144504033|SUPERIORITY||Difference in least squares means|-1.7|STANDARD_ERROR_OF_MEAN|0.3|<|0.0001|TWO_SIDED|95.0|-2.3|-1.1|||ANCOVA|||||-1.1|-2.3|<0.0001
72487654|NCT02187471|144504033|SUPERIORITY||Difference in least squares means|-1.2|STANDARD_ERROR_OF_MEAN|0.3||0.0001|TWO_SIDED|95.0|-1.7|-0.6|||ANCOVA|||||-0.6|-1.7|0.0001
72487655|NCT02187471|144504033|SUPERIORITY||Difference in least squares means|0.3|STANDARD_ERROR_OF_MEAN|0.3||0.3562|TWO_SIDED|95.0|-0.3|0.9|||ANCOVA|||||0.9|-0.3|0.3562
72487656|NCT02187471|144504033|SUPERIORITY||Difference in least squares means|-0.5|STANDARD_ERROR_OF_MEAN|0.3||0.0862|TWO_SIDED|95.0|-1.1|0.1|||ANCOVA|||||0.1|-1.1|0.0862
72487657|NCT02187471|144504034|SUPERIORITY||Difference in least square means|-0.2|STANDARD_ERROR_OF_MEAN|0.28||0.5183|TWO_SIDED|95.0|-0.7|0.4|||ANCOVA|||Anxiety: Placebo vs DS-5565 15 mg QD||0.4|-0.7|0.5183
72487658|NCT02187471|144504034|SUPERIORITY||Difference in least squares mean|-0.3|STANDARD_ERROR_OF_MEAN|0.28||0.2669|TWO_SIDED|95.0|-0.9|0.2|||ANCOVA|||Anxiety: Placebo vs DS-5565 15 mg BID||0.2|-0.9|0.2669
72487659|NCT02187471|144504034|SUPERIORITY||Difference in least squares means|-0.2|STANDARD_ERROR_OF_MEAN|0.28||0.463|TWO_SIDED|95.0|-0.8|0.3|||ANCOVA|||Anxiety: Placebo vs Pregabalin 150 mg BID||0.3|-0.8|0.4630
72487660|NCT02187471|144504034|SUPERIORITY||Difference in least squares means|0.0|STANDARD_ERROR_OF_MEAN|0.28||0.928|TWO_SIDED|95.0|-0.5|0.6|||ANCOVA|||Anxiety: Pregabalin 150 mg BID vs DS-5565 15 mg QD||0.6|-0.5|0.9280
72487661|NCT02187471|144504034|SUPERIORITY||Difference in least squares means|-0.1|STANDARD_ERROR_OF_MEAN|0.28||0.7089|TWO_SIDED|95.0|-0.7|0.5|||ANCOVA|||Anxiety: Pregabalin 150 mg BID vs DS-5565 15 mg BID||0.5|-0.7|0.7089
72487662|NCT02187471|144504034|SUPERIORITY||Difference in least squares means|-0.5|STANDARD_ERROR_OF_MEAN|0.28||0.0669|TWO_SIDED|95.0|-1.1|0.0|||ANCOVA|||Depression: Placebo vs DS-5565 15 mg QD||0|-1.1|0.0669
72514560|NCT01677507|144559982|OTHER||Mean Difference (Final Values)|0.2||||0.15|TWO_SIDED|95.0|-0.1|0.6|||t-test, 2 sided|paired t-test, 2 sided||Left eye, treated vs. untreated||0.6|-0.1|0.15
72487663|NCT02187471|144504034|SUPERIORITY||Difference in least squares means|-0.8|STANDARD_ERROR_OF_MEAN|0.28||0.0081|TWO_SIDED|95.0|-1.3|-0.2|||ANCOVA|||Depression: Placebo vs DS-5565 15 mg BID||-0.2|-1.3|0.0081
72487664|NCT02187471|144504034|SUPERIORITY||Difference in least squares means|-0.5|STANDARD_ERROR_OF_MEAN|0.28||0.0867|TWO_SIDED|95.0|-1.0|0.1|||ANCOVA|||Depression: Placebo vs Pregabalin 150 mg BID||0.1|-1.0|0.0867
72487665|NCT02187471|144504034|SUPERIORITY||Difference of least squares means|0.0|STANDARD_ERROR_OF_MEAN|0.29||0.9066|TWO_SIDED|95.0|-0.6|0.5|||ANCOVA|||Depression: Pregabalin 150 mg BID vs DS-5565 15 mg QD||0.5|-0.6|0.9066
72487666|NCT02187471|144504034|SUPERIORITY||Difference in least squares means|-0.3|STANDARD_ERROR_OF_MEAN|0.29||0.3509|TWO_SIDED|95.0|-0.8|0.3|||ANCOVA|||Depression: Pregabalin 150 mg BID vs DS-5565 15 mg BID||0.3|-0.8|0.3509
72487667|NCT02187471|144504035|SUPERIORITY||Difference in least squares means|2.187|STANDARD_ERROR_OF_MEAN|0.6203||0.0004|TWO_SIDED|95.0|0.97|3.404|||ANCOVA|||Physical Component: Placebo vs DS-5565 15 mg QD||3.404|0.970|0.0004
72514561|NCT01677507|144559982|OTHER||Mean Difference (Final Values)|0.1||||0.52|TWO_SIDED|95.0|-0.3|0.6|||t-test, 2 sided|paired t-test, 2 sided||Right Eye, treated vs. untreated||0.6|-0.3|0.52
72514562|NCT01677507|144559982|OTHER||Mean Difference (Final Values)|0.03||||0.88|TWO_SIDED|95.0|-0.4|0.4|||t-test, 2 sided|paired t-test, 2 sided||Left Eye, treated vs. untreated||0.4|-0.4|0.88
72487668|NCT02187471|144504035|SUPERIORITY||Difference of least squares means|2.483|STANDARD_ERROR_OF_MEAN|0.6209|<|0.0001|TWO_SIDED|95.0|1.265|3.701|||ANCOVA|||Physical Component: Placebo vs DS-5565 15 mg BID||3.701|1.265|<0.0001
72487669|NCT02187471|144504035|SUPERIORITY||Difference in least squares means|2.621|STANDARD_ERROR_OF_MEAN|0.6215|<|0.0001|TWO_SIDED|95.0|1.401|3.84|||ANCOVA|||Physical Component: Placebo vs Pregabalin 150 mg BID||3.840|1.401|<0.0001
72487670|NCT02187471|144504035|SUPERIORITY||Difference in least squares means|-0.434|STANDARD_ERROR_OF_MEAN|0.6245||0.4877|TWO_SIDED|95.0|-1.659|0.792|||ANCOVA|||Physical Component: Pregabalin 150 mg BID vs DS-5565 15 mg QD||0.792|-1.659|0.4877
72487671|NCT02187471|144504035|SUPERIORITY||Difference in least squares means|-0.137|STANDARD_ERROR_OF_MEAN|0.6252||0.8263|TWO_SIDED|95.0|-1.364|1.089|||ANCOVA|||Physical Component: Pregabalin 150 mg BID vs DS-5565 15 mg BID||1.089|-1.364|0.8263
72487672|NCT02187471|144504035|SUPERIORITY||Difference in least squares means|0.228|STANDARD_ERROR_OF_MEAN|0.7345||0.7567|TWO_SIDED|95.0|-1.213|1.669|||ANCOVA|||Mental Component: Placebo vs DS-5565 15 mg QD||1.669|-1.213|0.7567
72487673|NCT02187471|144504035|SUPERIORITY||Difference in least squares means|0.7349|STANDARD_ERROR_OF_MEAN|0.7349||0.0787|TWO_SIDED|95.0|-0.149|2.735|||ANCOVA|||Mental Component: Placebo vs DS-5565 15 mg BID||2.735|-0.149|0.0787
72487674|NCT02187471|144504035|SUPERIORITY||Difference in least squares means|0.7358|STANDARD_ERROR_OF_MEAN|0.7358||0.3516|TWO_SIDED|95.0|-0.758|2.129|||ANCOVA|||Mental Component: Placebo vs Pregabalin 150 mg BID||2.129|-0.758|0.3516
72487675|NCT02187471|144504035|SUPERIORITY||Difference in least squares means|-0.458|STANDARD_ERROR_OF_MEAN|0.7372||0.5344|TWO_SIDED|95.0|-1.905|0.988|||ANCOVA|||Mental Component: Pregabalin 150 mg BID vs DS-5565 15 mg QD||0.988|-1.905|0.5344
72487676|NCT02187471|144504035|SUPERIORITY||Difference in least squares means|0.607|STANDARD_ERROR_OF_MEAN|0.7379||0.4107|TWO_SIDED|95.0|-0.84|2.055|||ANCOVA|||Mental Component: Pregabalin 150 mg BID vs DS-5565 15 mg BID||2.055|-0.840|0.4107
72487677|NCT02187471|144504036|SUPERIORITY||Difference in least squares means|0.0203|STANDARD_ERROR_OF_MEAN|0.01369||0.1394|TWO_SIDED|95.0|-0.0066|0.0471|||ANCOVA|||||0.0471|-0.0066|0.1394
72487678|NCT02187471|144504036|SUPERIORITY||Difference in least squares means|0.0211|STANDARD_ERROR_OF_MEAN|0.01369||0.1237|TWO_SIDED|95.0|-0.0058|0.048|||ANCOVA|||||0.0480|-0.0058|0.1237
72487679|NCT02187471|144504036|SUPERIORITY||Difference in least squares means|0.0386|STANDARD_ERROR_OF_MEAN|0.01371||0.0049|TWO_SIDED|95.0|0.0117|0.0655|||ANCOVA|||||0.0655|0.0117|0.0049
72487680|NCT02187471|144504036|SUPERIORITY||Difference in least squares means|-0.0184|STANDARD_ERROR_OF_MEAN|0.01378||0.1824|TWO_SIDED|95.0|-0.0454|0.0086|||ANCOVA|||||0.0086|-0.0454|0.1824
72487681|NCT02187471|144504036|SUPERIORITY||Difference in least squares means|-0.0175|STANDARD_ERROR_OF_MEAN|0.01378||0.2036|TWO_SIDED|95.0|-0.0446|0.0095|||ANCOVA|||||0.0095|-0.0446|0.2036
72403256|NCT03441633|144312224|SUPERIORITY||Odds Ratio (OR)|1.01||||0|TWO_SIDED|95.0|0.88|1.16|||Chi-squared|||Rivaroxaban vs. Apixaban in naive participants (18.5 - 25 kg per m\^2 Normal)||1.16|0.88|0.000
72568008|NCT02037165|144667472|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.76|STANDARD_ERROR_OF_MEAN|1.0986|||TWO_SIDED|95.0|-1.4|2.9|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 24:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||2.9|-1.4|
72568009|NCT02037165|144667473|SUPERIORITY_OR_OTHER||adjusted mean difference|-6.13|STANDARD_ERROR_OF_MEAN|3.2064|||TWO_SIDED|95.0|-12.5|0.2|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 0:30h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||0.2|-12.5|
72568010|NCT02037165|144667473|SUPERIORITY_OR_OTHER||adjusted mean difference|-3.88|STANDARD_ERROR_OF_MEAN|3.4032|||TWO_SIDED|95.0|-10.6|2.9|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 1:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||2.9|-10.6|
72403257|NCT03441633|144312224|SUPERIORITY||Odds Ratio (OR)|1.22||||0.202|TWO_SIDED|95.0|0.58|2.66|||Chi-squared|||Rivaroxaban vs. Apixaban in naive participants (\<18.5 kg per m\^2 Underweight)||2.66|0.58|0.202
72487682|NCT02187471|144504037|SUPERIORITY||Difference in least squares means|-0.56|STANDARD_ERROR_OF_MEAN|0.162||0.0006|TWO_SIDED|95.0|-0.87|-0.24|||Mixed Models Analysis|||||-0.24|-0.87|0.0006
72487683|NCT02187471|144504037|SUPERIORITY||Difference in least squares means|-0.88|STANDARD_ERROR_OF_MEAN|0.16|<|0.0001|TWO_SIDED|95.0|-1.2|-0.57|||Mixed Models Analysis|||||-0.57|-1.20|<0.0001
72487684|NCT02187471|144504037|SUPERIORITY||Difference in least squares means|-0.95|STANDARD_ERROR_OF_MEAN|0.161|<|0.0001|TWO_SIDED|95.0|-1.27|-0.63|||Mixed Models Analysis|||||-0.63|-1.27|<0.0001
72487685|NCT02187471|144504037|SUPERIORITY||Difference in least squares means|0.39|STANDARD_ERROR_OF_MEAN|0.162||0.0158|TWO_SIDED|95.0|0.07|0.71|||Mixed Models Analysis|||||0.71|0.07|0.0158
72487686|NCT02187471|144504037|SUPERIORITY||Difference in least squares means|0.07|STANDARD_ERROR_OF_MEAN|0.161||0.6819|TWO_SIDED|95.0|-0.25|0.38|||Mixed Models Analysis|||||0.38|-0.25|0.6819
72487687|NCT02187471|144504039|SUPERIORITY||Difference of least squares means|-0.8|STANDARD_ERROR_OF_MEAN|0.19|<|0.0001|TWO_SIDED|95.0|-1.2|-0.4|||ANCOVA|||Worst pain: Placebo vs Pregabalin 150 mg BID||-0.4|-1.2|<0.0001
72487688|NCT02187471|144504039|SUPERIORITY||Difference of least squares means|-0.2|STANDARD_ERROR_OF_MEAN|0.19||0.2005|TWO_SIDED|95.0|-0.6|0.1|||ANCOVA|||Worst pain: Placebo vs DS-5565 15 mg QD||0.1|-0.6|0.2005
72577088|NCT01371747|144680809|SUPERIORITY_OR_OTHER_LEGACY||Percentage of Participants|86.3|||||TWO_SIDED|95.0|73.7|94.3|||||2-sided 95% exact binomial CI|||94.3|73.7|
72487689|NCT02187471|144504039|SUPERIORITY||Difference in least squares means|-0.6|STANDARD_ERROR_OF_MEAN|0.19||0.001|TWO_SIDED|95.0|-1.0|-0.3|||ANCOVA|||Worst pain: Placebo vs DS-5565 15 mg BID||-0.3|-1.0|0.0010
72577089|NCT01371747|144680809|SUPERIORITY_OR_OTHER_LEGACY||Percentage of Participants|81.6|||||TWO_SIDED|95.0|68.0|91.2|||||2-sided 95% exact binomial CI|||91.2|68.0|
72577090|NCT01371747|144680809|SUPERIORITY_OR_OTHER_LEGACY||Percentage of Participants|88.9|||||TWO_SIDED|95.0|75.9|96.3|||||2-sided 95% exact binomial CI|||96.3|75.9|
72487690|NCT02187471|144504039|SUPERIORITY||Difference in least squares means|0.6|STANDARD_ERROR_OF_MEAN|0.19||0.003|TWO_SIDED|95.0|0.2|1.0|||ANCOVA|||Worst pain: Pregabalin 150 mg BID vs DS-5565 15 mg QD||1.0|0.2|0.0030
72487691|NCT02187471|144504039|SUPERIORITY||Difference in least squares means|0.2|STANDARD_ERROR_OF_MEAN|0.19||0.3351|TWO_SIDED|95.0|-0.2|0.6|||ANCOVA|||Worst pain: Pregabalin 150 mg BID vs DS-5565 15 mg BID||0.6|-0.2|0.3351
72403258|NCT03441633|144312224|SUPERIORITY||Odds Ratio (OR)|0.95||||0|TWO_SIDED|95.0|0.87|1.04|||Chi-squared|||Rivaroxaban vs. Apixaban in naive participants (25 - 30 kg per m\^2 Overweight)||1.04|0.87|0.000
72403259|NCT03441633|144312224|SUPERIORITY||Odds Ratio (OR)|0.87||||0.003|TWO_SIDED|95.0|0.8|0.95|||Chi-squared|||Rivaroxaban vs. Apixaban in naive participants (\>30 kg per m\^2 Obese)||0.95|0.80|0.003
72487692|NCT02187471|144504039|SUPERIORITY||Difference in least squares means|-0.8|STANDARD_ERROR_OF_MEAN|0.18|<|0.0001|TWO_SIDED|95.0|-1.1|-0.4|||ANCOVA|||Least pain: Placebo vs Pregabalin 150 mg BID||-0.4|-1.1|<0.0001
72487693|NCT02187471|144504039|SUPERIORITY||Difference in least squares means|-0.3|STANDARD_ERROR_OF_MEAN|0.18||0.0782|TWO_SIDED|95.0|-0.7|0.0|||ANCOVA|||Least pain: Placebo vs DS-5565 15 mg QD||0.0|-0.7|0.0782
72487694|NCT02187471|144504039|SUPERIORITY||Difference in least squares means|-0.5|STANDARD_ERROR_OF_MEAN|0.18||0.0068|TWO_SIDED|95.0|-0.9|-0.1|||ANCOVA|||Least pain: Placebo vs DS-5565 15 mg BID||-0.1|-0.9|0.0068
72487695|NCT02187471|144504039|SUPERIORITY||Difference in least squares means|0.4|STANDARD_ERROR_OF_MEAN|0.19||0.0169|TWO_SIDED|95.0|0.1|0.8|||ANCOVA|||Least pain: Pregabalin 150 mg BID vs DS-5565 15 mg QD||0.8|0.1|0.0169
72487696|NCT02187471|144504039|SUPERIORITY||Difference in least squares means|0.3|STANDARD_ERROR_OF_MEAN|0.19||0.1481|TWO_SIDED|95.0|-0.1|0.6|||ANCOVA|||Least pain: Pregabalin 150 mg BID vs DS-5565 15 mg BID||0.6|-0.1|0.1481
72487697|NCT02187471|144504039|SUPERIORITY||Difference in least squares means|-0.8|STANDARD_ERROR_OF_MEAN|0.17|<|0.0001|TWO_SIDED|95.0|-1.1|-0.4|||ANCOVA|||Average pain: Placebo vs Pregabalin 150 mg BID||-0.4|-1.1|<0.0001
72487698|NCT02187471|144504039|SUPERIORITY||Difference in least squares means|-0.4|STANDARD_ERROR_OF_MEAN|0.17||0.0088|TWO_SIDED|95.0|-0.8|-0.1|||ANCOVA|||Average pain: Placebo vs DS-5565 15 mg QD||-0.1|-0.8|0.0088
72403260|NCT03441633|144312224|SUPERIORITY||Odds Ratio (OR)|0.97||||0.083|TWO_SIDED|95.0|0.8|1.17|||Chi-squared|||Rivaroxaban vs. Apixaban in non-naive participants (18.5 - 25 kg per m\^2 Normal)||1.17|0.80|0.083
72403261|NCT03441633|144312224|SUPERIORITY||Odds Ratio (OR)|0.06||||0.011|TWO_SIDED|95.0|0.02|1.05|||Chi-squared|||Rivaroxaban vs. Apixaban in non-naive participants (\<18.5 kg per m\^2 Underweight)||1.05|0.02|0.011
72403262|NCT03441633|144312224|SUPERIORITY||Odds Ratio (OR)|0.84||||0.227|TWO_SIDED|95.0|0.72|0.98|||Chi-squared|||Rivaroxaban vs. Apixaban in non-naive participants (25 - 30 kg per m\^2 Overweight)||0.98|0.72|0.227
72403263|NCT03441633|144312224|SUPERIORITY||Odds Ratio (OR)|1.16||||0|TWO_SIDED|95.0|0.99|1.35|||Chi-squared|||Rivaroxaban vs. Apixaban in non-naive participants (\>30 kg per m\^2 Obese)||1.35|0.99|0.000
72403264|NCT03441633|144312224|SUPERIORITY||Odds Ratio (OR)|1.63||||0|TWO_SIDED|95.0|1.47|1.82|||Chi-squared|||Acenocoumarol vs. Apixaban in naive participants (18.5 - 25 kg per m\^2 Normal)||1.82|1.47|0.000
72403265|NCT03441633|144312224|SUPERIORITY||Odds Ratio (OR)|1.7||||0.202|TWO_SIDED|95.0|0.98|3.25|||Chi-squared|||Acenocoumarol vs. Apixaban in naive participants (\<18.5 kg per m\^2 Underweight)||3.25|0.98|0.202
72403266|NCT03441633|144312224|SUPERIORITY||Odds Ratio (OR)|1.29||||0|TWO_SIDED|95.0|1.2|1.38|||Chi-squared|||Acenocoumarol vs. Apixaban in naive participants (25 - 30 kg per m\^2 Overweight)||1.38|1.20|0.000
72403267|NCT03441633|144312224|SUPERIORITY||Odds Ratio (OR)|0.94||||0.003|TWO_SIDED|95.0|0.88|1.0|||Chi-squared|||Acenocoumarol vs. Apixaban in naive participants (\>30 kg per m\^2 Obese)||1.00|0.88|0.003
72403268|NCT03441633|144312224|SUPERIORITY||Odds Ratio (OR)|0.86||||0.083|TWO_SIDED|95.0|0.56|1.28|||Chi-squared|||Acenocoumarol vs. Apixaban in non-naive participants (18.5 - 25 kg per m\^2 Normal)||1.28|0.56|0.083
72403269|NCT03441633|144312224|SUPERIORITY||Odds Ratio (OR)|0.49||||0.011|TWO_SIDED|95.0|0.13|8.58|||Chi-squared|||Acenocoumarol vs. Apixaban in non-naive participants (\<18.5 kg per m\^2 Underweight)||8.58|0.13|0.011
72403270|NCT03441633|144312224|SUPERIORITY||Odds Ratio (OR)|1.04||||0.227|TWO_SIDED|95.0|0.75|1.42|||Chi-squared|||Acenocoumarol vs. Apixaban in non-naive participants (25 - 30 kg per m\^2 Overweight)||1.42|0.75|0.227
72403271|NCT03441633|144312224|SUPERIORITY||Odds Ratio (OR)|1.12||||0|TWO_SIDED|95.0|0.81|1.55|||Chi-squared|||Acenocoumarol vs. Apixaban in non-naive participants (\>30 kg per m\^2 Obese)||1.55|0.81|0.000
72403272|NCT03441633|144312224|SUPERIORITY||Odds Ratio (OR)|1.5||||0|TWO_SIDED|95.0|1.28|1.76|||Chi-squared|||Warfarin vs. Apixaban in naive participants (18.5 - 25 kg per m\^2 Normal)||1.76|1.28|0.000
72514563|NCT03004469|144560007|OTHER||LS Mean Difference|13.6|STANDARD_ERROR_OF_MEAN|3.94|<|0.001|TWO_SIDED|95.0|5.8|21.3|||Mixed linear model|||||21.3|5.8|<.001
72514564|NCT03004469|144560008|OTHER||LS Mean Difference|12.8|STANDARD_ERROR_OF_MEAN|3.19|<|0.001|TWO_SIDED|95.0|6.5|19.1|||Mixed linear model|||||19.1|6.5|<.001
72514565|NCT03004469|144560009|OTHER||LS Mean Difference|-0.4024|STANDARD_ERROR_OF_MEAN|0.4057||0.322|TWO_SIDED|95.0|-1.202|0.3971|||Mixed linear model|||Statistical Analysis details presented here is for Week 12||0.3971|-1.2020|0.322
72514566|NCT03004469|144560009|OTHER||LS Mean Difference|0.7237|STANDARD_ERROR_OF_MEAN|0.47799||0.131|TWO_SIDED|95.0|-0.2184|1.6657|||Mixed linear model|||Statistical Analysis details presented here is for Week 24||1.6657|-0.2184|0.131
72514567|NCT03004469|144560010|OTHER||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.11||0.569|TWO_SIDED|95.0|-0.3|0.2|||Mixed linear model|||Statistical Analysis details presented here is for Week 12||0.2|-0.3|0.569
72514568|NCT03004469|144560010|OTHER||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.12||0.129|TWO_SIDED|95.0|-0.4|0.1|||Mixed linear model|||Statistical Analysis details presented here is for Week 24||0.1|-0.4|0.129
72514569|NCT03004469|144560011|OTHER||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.14||0.708|TWO_SIDED|95.0|-0.2|0.3|||Mixed linear model|||Statistical Analysis details presented here is for Week 12||0.3|-0.2|0.708
72514570|NCT03004469|144560011|OTHER||LS Mean Difference|0.4|STANDARD_ERROR_OF_MEAN|0.12|<|0.001|TWO_SIDED|95.0|0.2|0.7|||Mixed linear model|||Statistical Analysis details presented here is for Week 24||0.7|0.2|<.001
72514571|NCT03004469|144560012|OTHER||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.1||0.179|TWO_SIDED|95.0|-0.3|0.1|||Mixed linear model|||Statistical Analysis details presented here is for Week 12||0.1|-0.3|0.179
72514572|NCT03004469|144560012|OTHER||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.12||0.262|TWO_SIDED|95.0|-0.1|0.4|||Mixed linear model|||Statistical Analysis details presented here is for Week 24||0.4|-0.1|0.262
72514573|NCT03004469|144560013|OTHER||LS Mean Difference|-1.7|STANDARD_ERROR_OF_MEAN|1.03||0.103|TWO_SIDED|95.0|-3.7|0.3|||Mixed linear model|||Statistical Analysis details presented here is for Erectile Function Score, Week 4||0.3|-3.7|0.103
72514574|NCT03004469|144560013|OTHER||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|1.1||0.545|TWO_SIDED|95.0|-2.8|1.5|||Mixed linear model|||Statistical Analysis details presented here is for Erectile Function Score, Week 8||1.5|-2.8|0.545
72514575|NCT03004469|144560013|OTHER||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|1.0||0.842|TWO_SIDED|95.0|-2.2|1.8|||Mixed linear model|||Statistical Analysis details presented here is for Erectile Function Score, Week 12||1.8|-2.2|0.842
72514576|NCT03004469|144560013|OTHER||LS Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|1.02||0.449|TWO_SIDED|95.0|-2.8|1.2|||Mixed linear model|||Statistical Analysis details presented here is for Erectile Function Score, Week 24||1.2|-2.8|0.449
72514577|NCT03004469|144560013|OTHER||LS Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|0.28||0.272|TWO_SIDED|95.0|-0.2|0.9|||Mixed linear model|||Statistical Analysis details presented here is for Orgasmic Function Score, Week 4||0.9|-0.2|0.272
72514578|NCT03004469|144560013|OTHER||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.36||0.918|TWO_SIDED|95.0|-0.7|0.8|||Mixed linear model|||Statistical Analysis details presented here is for Orgasmic Function Score, Week 8||0.8|-0.7|0.918
72514579|NCT03004469|144560013|OTHER||LS Mean Difference|0.5|STANDARD_ERROR_OF_MEAN|0.078||0.078|TWO_SIDED|95.0|-0.1|1.1|||Mixed linear model|||Statistical Analysis details presented here is for Orgasmic Function Score, Week 12||1.1|-0.1|0.078
72514580|NCT03004469|144560013|OTHER||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.34||0.593|TWO_SIDED|95.0|-0.9|0.5|||Mixed linear model|||Statistical Analysis details presented here is for Orgasmic Function Score, Week 24||0.5|-0.9|0.593
72514581|NCT03004469|144560013|OTHER||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.23||0.295|TWO_SIDED|95.0|-0.7|0.2|||Mixed linear model|||Statistical Analysis details presented here is for Sexual Desire Score, Week 4||0.2|-0.7|0.295
72577091|NCT01371747|144680809|SUPERIORITY_OR_OTHER_LEGACY||Percentage of Participants|86.7|||||TWO_SIDED|95.0|59.5|98.3|||||2-sided 95% exact binomial CI|||98.3|59.5|
72568011|NCT02037165|144667473|SUPERIORITY_OR_OTHER||adjusted mean difference|-6.67|STANDARD_ERROR_OF_MEAN|3.3393|||TWO_SIDED|95.0|-13.3|0.0|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 2:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||-0.0|-13.3|
72568012|NCT02037165|144667473|SUPERIORITY_OR_OTHER||adjusted mean difference|-1.8|STANDARD_ERROR_OF_MEAN|3.5727|||TWO_SIDED|95.0|-8.9|5.3|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 3:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||5.3|-8.9|
72568013|NCT02037165|144667473|SUPERIORITY_OR_OTHER||adjusted mean difference|-4.43|STANDARD_ERROR_OF_MEAN|3.1554|||TWO_SIDED|95.0|-10.7|1.8|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 4:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||1.8|-10.7|
72568014|NCT02037165|144667473|SUPERIORITY_OR_OTHER||adjusted mean difference|-1.18|STANDARD_ERROR_OF_MEAN|2.6161|||TWO_SIDED|95.0|-6.4|4.0|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 5:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||4.0|-6.4|
72568015|NCT02037165|144667473|SUPERIORITY_OR_OTHER||adjusted mean difference|-2.35|STANDARD_ERROR_OF_MEAN|3.1849|||TWO_SIDED|95.0|-8.7|4.0|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 6:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||4.0|-8.7|
72568016|NCT02037165|144667473|SUPERIORITY_OR_OTHER||adjusted mean difference|-2.78|STANDARD_ERROR_OF_MEAN|3.7688|||TWO_SIDED|95.0|-10.3|4.7|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 22:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||4.7|-10.3|
72568017|NCT02037165|144667473|SUPERIORITY_OR_OTHER||adjusted mean difference|-1.27|STANDARD_ERROR_OF_MEAN|2.857|||TWO_SIDED|95.0|-7.0|4.4|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 24:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||4.4|-7.0|
72403273|NCT03441633|144312224|SUPERIORITY||Odds Ratio (OR)|1.04||||0.202|TWO_SIDED|95.0|0.36|2.73|||Chi-squared|||Warfarin vs. Apixaban in naive participants (\<18.5 kg per m\^2 Underweight)||2.73|0.36|0.202
72568018|NCT02037165|144667473|SUPERIORITY_OR_OTHER||adjusted mean difference|-6.91|STANDARD_ERROR_OF_MEAN|3.1527|||TWO_SIDED|95.0|-13.2|-0.07|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 0:30h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||-.07|-13.2|
72577092|NCT01371747|144680809|SUPERIORITY_OR_OTHER_LEGACY||Percentage of Participants|89.5|||||TWO_SIDED|95.0|66.9|98.7|||||2-sided 95% exact binomial CI|||98.7|66.9|
72577093|NCT01371747|144680809|SUPERIORITY_OR_OTHER_LEGACY||Percentage of Participants|93.3|||||TWO_SIDED|95.0|68.1|99.8|||||2-sided 95% exact binomial CI|||99.8|68.1|
72403274|NCT03441633|144312224|SUPERIORITY||Odds Ratio (OR)|1.28||||0|TWO_SIDED|95.0|1.15|1.43|||Chi-squared|||Warfarin vs. Apixaban in naive participants (25 - 30 kg per m\^2 Overweight)||1.43|1.15|0.000
72403275|NCT03441633|144312224|SUPERIORITY||Odds Ratio (OR)|0.95||||0.003|TWO_SIDED|95.0|0.86|1.06|||Chi-squared|||Warfarin vs. Apixaban in naive participants (\>30 kg per m\^2 Obese)||1.06|0.86|0.003
72403276|NCT03441633|144312224|SUPERIORITY||Odds Ratio (OR)|1.27||||0.083|TWO_SIDED|95.0|0.95|1.68|||Chi-squared|||Warfarin vs. Apixaban in non-naive participants (18.5 - 25 kg per m\^2 Normal)||1.68|0.95|0.083
72568019|NCT02037165|144667473|SUPERIORITY_OR_OTHER||adjusted mean difference|-4.22|STANDARD_ERROR_OF_MEAN|3.3457|||TWO_SIDED|95.0|-10.9|2.4|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 1:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||2.4|-10.9|
72568020|NCT02037165|144667473|SUPERIORITY_OR_OTHER||adjusted mean difference|-3.61|STANDARD_ERROR_OF_MEAN|3.2806|||TWO_SIDED|95.0|-10.1|2.9|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 2:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||2.9|-10.1|
72568021|NCT02037165|144667473|SUPERIORITY_OR_OTHER||adjusted mean difference|-0.8|STANDARD_ERROR_OF_MEAN|3.5078|||TWO_SIDED|95.0|-7.8|6.2|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 3:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||6.2|-7.8|
72568022|NCT02037165|144667473|SUPERIORITY_OR_OTHER||adjusted mean difference|-0.05|STANDARD_ERROR_OF_MEAN|3.0965|||TWO_SIDED|95.0|-6.2|6.1|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 4:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||6.1|-6.2|
72568023|NCT02037165|144667473|SUPERIORITY_OR_OTHER||adjusted mean difference|-1.05|STANDARD_ERROR_OF_MEAN|2.5649|||TWO_SIDED|95.0|-6.1|4.0|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 5:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||4.0|-6.1|
72568024|NCT02037165|144667473|SUPERIORITY_OR_OTHER||adjusted mean difference|-2.59|STANDARD_ERROR_OF_MEAN|3.125|||TWO_SIDED|95.0|-8.8|3.7|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 6:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||3.7|-8.8|
72568025|NCT02037165|144667473|SUPERIORITY_OR_OTHER||adjusted mean difference|-3.84|STANDARD_ERROR_OF_MEAN|3.7013|||TWO_SIDED|95.0|-11.2|3.5|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 22:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||3.5|-11.2|
72568026|NCT02037165|144667473|SUPERIORITY_OR_OTHER||adjusted mean difference|-3.05|STANDARD_ERROR_OF_MEAN|2.8201|||TWO_SIDED|95.0|-8.7|2.6|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 24:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||2.6|-8.7|
72577094|NCT00580788|144680811|NON_INFERIORITY_OR_EQUIVALENCE|The study was designed as a standard dose-escalation study, dose-finding pilot study. The primary outcome measures were safety (hypercalcemia, hypophosphatemia and symptoms/hemodynamic measurements). A modified Fibronacci dose-escalation scheme was employed.|||||>|0.05|TWO_SIDED|||||The reported p-value corresponds to change over time for the PTHrP 2 and PTHrP 5 pmol groups|Mixed Models Analysis|The level of statistical significance was set at .05 (two-tailed)||||||>0.05
72403277|NCT03441633|144312224|SUPERIORITY||Odds Ratio (OR)|1.37||||0.011|TWO_SIDED|95.0|0.18|6.21|||Chi-squared|||Warfarin vs. Apixaban in non-naive participants (\<18.5 kg per m\^2 Underweight)||6.21|0.18|0.011
72403278|NCT03441633|144312224|SUPERIORITY||Odds Ratio (OR)|0.92||||0.227|TWO_SIDED|95.0|0.72|1.17|||Chi-squared|||Warfarin vs. Apixaban in non-naive participants (25 - 30 kg per m\^2 Overweight)||1.17|0.72|0.227
72403279|NCT03441633|144312224|SUPERIORITY||Odds Ratio (OR)|0.67||||0|TWO_SIDED|95.0|0.5|0.87|||Chi-squared|||Warfarin vs. Apixaban in non-naive participants (\>30 kg per m\^2 Obese)||0.87|0.50|0.000
72487699|NCT02187471|144504039|SUPERIORITY||Difference in least squares means|-0.6|STANDARD_ERROR_OF_MEAN|0.17||0.0005|TWO_SIDED|95.0|-0.9|-0.3|||ANCOVA|||Average pain: Placebo vs DS-5565 15 mg BID||-0.3|-0.9|0.0005
72487700|NCT02187471|144504039|SUPERIORITY||Difference in least squares means|0.3|STANDARD_ERROR_OF_MEAN|0.17||0.0627|TWO_SIDED|95.0|0.0|0.7|||ANCOVA|||Average pain: Pregabalin 150 mg BID vs DS-5565 15 mg QD||0.7|-0.0|0.0627
72487701|NCT02187471|144504039|SUPERIORITY||Difference in least squares means|0.2|STANDARD_ERROR_OF_MEAN|0.17||0.3064|TWO_SIDED|95.0|-0.2|0.5|||ANCOVA|||Average pain: Pregabalin 150 mg BID vs DS-5565 15 mg BID||0.5|-0.2|0.3064
72487702|NCT02187471|144504039|SUPERIORITY||Difference in least squares means|-0.8|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001|TWO_SIDED|95.0|-1.2|-0.4|||ANCOVA|||Pain right now: Placebo vs Pregabalin 150 mg BID||-0.4|-1.2|<0.0001
72487703|NCT02187471|144504039|SUPERIORITY||Difference in least squares mean|-0.3|STANDARD_ERROR_OF_MEAN|0.2||0.0868|TWO_SIDED|95.0|-0.7|0.0|||ANCOVA|||Pain right now: Placebo vs DS-5565 15 mg QD||0.0|-0.7|0.0868
72487704|NCT02187471|144504039|SUPERIORITY||Difference in least squares means|-0.7|STANDARD_ERROR_OF_MEAN|0.2||0.0004|TWO_SIDED|95.0|-1.1|-0.3|||ANCOVA|||Pain right now: Placebo vs DS-5565 15 mg BID||-0.3|-1.1|0.0004
72487705|NCT02187471|144504039|SUPERIORITY||Difference in least squares means|0.4|STANDARD_ERROR_OF_MEAN|0.2||0.0271|TWO_SIDED|95.0|0.1|0.8|||ANCOVA|||Pain right now: Pregabalin 150 mg BID vs DS-5565 15 mg QD||0.8|0.1|0.0271
72487706|NCT02187471|144504039|SUPERIORITY||Difference in least squares means|0.1|STANDARD_ERROR_OF_MEAN|0.2||0.6838|TWO_SIDED|95.0|-0.3|0.5|||ANCOVA|||Pain right now: Pregabalin 150 mg BID vs DS-5565 15 mg BID||0.5|-0.3|0.6838
72487707|NCT02187471|144504039|SUPERIORITY||Difference in least squares means|-0.791|STANDARD_ERROR_OF_MEAN|0.172|<|0.0001|TWO_SIDED|95.0|-1.129|-0.454|||ANCOVA|||Severity score: Placebo vs Pregabalin 150 mg BID||-0.454|-1.129|<0.0001
72487708|NCT02187471|144504039|SUPERIORITY||Difference in least squares means|-0.33|STANDARD_ERROR_OF_MEAN|0.1718||0.0552|TWO_SIDED|95.0|-0.667|0.007|||ANCOVA|||Severity score: Placebo vs DS-5565 15 mg QD||0.007|-0.667|0.0552
72487709|NCT02187471|144504039|SUPERIORITY||Difference in least squares means|-0.612|STANDARD_ERROR_OF_MEAN|0.1718||0.0004|TWO_SIDED|95.0|-0.95|-0.275|||ANCOVA|||Severity score: Placebo vs DS-5565 15 mg BID||-0.275|-0.950|0.0004
72487710|NCT02187471|144504039|SUPERIORITY||Difference in least squares means|0.462|STANDARD_ERROR_OF_MEAN|0.1729||0.0077|TWO_SIDED|95.0|0.122|0.801|||ANCOVA|||Severity score: Pregabalin 150 mg BID vs DS-5565 15 mg QD||0.801|0.122|0.0077
72487711|NCT02187471|144504039|SUPERIORITY||Difference in least squares means|0.179|STANDARD_ERROR_OF_MEAN|0.173||0.3014|TWO_SIDED|95.0|-0.161|0.518|||ANCOVA|||Severity score: Pregabalin 150 mg BID vs DS-5565 15 mg BID||0.518|-0.161|0.3014
72487712|NCT02187471|144504039|SUPERIORITY||Difference in least squares means|9.6|STANDARD_ERROR_OF_MEAN|2.4|<|0.0001|TWO_SIDED|95.0|4.9|14.3|||ANCOVA|||Relief (%) by treatment of pain: Placebo vs Pregabalin 150 mg BID||14.3|4.9|<0.0001
72487713|NCT02187471|144504039|SUPERIORITY||Difference in least squares means|8.5|STANDARD_ERROR_OF_MEAN|2.39||0.0004|TWO_SIDED|95.0|3.8|13.2|||ANCOVA|||Relief (%) by treatment of pain: Placebo vs DS-5565 15 mg QD||13.2|3.8|0.0004
72487714|NCT02187471|144504039|SUPERIORITY||Difference in least squares means|10.4|STANDARD_ERROR_OF_MEAN|2.39|<|0.0001|TWO_SIDED|95.0|5.7|15.1|||ANCOVA|||Relief (%) by treatment of pain: Placebo vs DS-5565 15 mg BID||15.1|5.7|<0.0001
72487715|NCT02187471|144504039|SUPERIORITY||Difference in least squares means|-1.1|STANDARD_ERROR_OF_MEAN|2.41||0.6449|TWO_SIDED|95.0|-5.8|3.6|||ANCOVA|||Relief (%) by treatment of pain: Pregabalin 150 mg BID vs DS-5565 15 mg QD||3.6|-5.8|0.6449
72487716|NCT02187471|144504039|SUPERIORITY||Difference in least square means|0.8|STANDARD_ERROR_OF_MEAN|2.41||0.734|TWO_SIDED|95.0|-3.9|5.5|||ANCOVA|||Relief (%) by treatment of pain: Pregabalin 150 mg BID vs DS-5565 15 mg BID||5.5|-3.9|0.7340
72487717|NCT02187471|144504040|SUPERIORITY||Difference in least squares means|-0.016|STANDARD_ERROR_OF_MEAN|0.0225||0.4816|TWO_SIDED|95.0|-0.06|0.028|||ANCOVA|||||0.028|-0.060|0.4816
72487718|NCT02187471|144504040|SUPERIORITY||Difference in least square means|-0.064|STANDARD_ERROR_OF_MEAN|0.0225||0.0044|TWO_SIDED|95.0|-0.109|-0.02|||ANCOVA|||||-0.020|-.109|0.0044
72487719|NCT02187471|144504040|SUPERIORITY||Difference in least squares means|-0.074|STANDARD_ERROR_OF_MEAN|0.0226||0.001|TWO_SIDED|95.0|-0.119|-0.03|||ANCOVA|||||-0.030|-0.119|0.0010
72487720|NCT02187471|144504040|SUPERIORITY||Difference in least squares means|0.059|STANDARD_ERROR_OF_MEAN|0.0226||0.0094|TWO_SIDED|95.0|0.014|0.103|||ANCOVA|||||0.103|0.014|0.0094
72487721|NCT02187471|144504040|SUPERIORITY||Difference in least squares means|0.01|STANDARD_ERROR_OF_MEAN|0.0226||0.6527|TWO_SIDED|95.0|-0.034|0.055|||ANCOVA|||||0.055|-0.034|0.6527
72487722|NCT01785160|144504042|NON_INFERIORITY_OR_EQUIVALENCE|Relative bioavailability (No formal testing was performed)|Adjusted Geometric Mean ratio|272.06|STANDARD_DEVIATION|67.9||0.9999||95.0|199.69|370.66||P-value for ratio outside interval 0.8-1.25|ANOVA|Adjusted geometric mean ratio|The standard deviation is actually the geometric coefficient of variation|Ratio Raltegravir plus Faldaprevir and Raltegravir for the category Raltegravir||370.66|199.69|0.9999
72487723|NCT01785160|144504043|NON_INFERIORITY_OR_EQUIVALENCE|Relative bioavailability(No formal testing was performed)|Adjusted Geometric Mean ratio|245.72|STANDARD_DEVIATION|87.1||0.9973||95.0|168.46|358.404||P-value for ratio outside interval 0.8-1.25|ANOVA|Adjusted geometric mean ratio|The standard deviation is actually the geometric coefficient of variation|Ratio Raltegravir plus Faldaprevir and Raltegravir for the category Raltegravir||358.404|168.460|0.9973
72487724|NCT02318667|144504055|OTHER|||||||0.0074|||||||t-test, 2 sided|||||||0.0074
72487725|NCT02318667|144504056|OTHER|||||||0.1506|||||||t-test, 2 sided|||||||0.1506
72487726|NCT04223843|144504069|OTHER||Difference of adjusted means|0.336|STANDARD_ERROR_OF_MEAN|0.045|<|0.0001|TWO_SIDED|95.0|0.246|0.425|||ANCOVA|Model included fixed categorical effects of treatment and the fixed continous effect of baseline FEV1 AUC0-3.|Difference = (Tio+Olo) - (Placebo)|H0: There is no difference in the mean FEV1 AUC0-3 change from baseline between Tio+Olo and matching placebo.||0.425|0.246|<0.0001
72514582|NCT03004469|144560013|OTHER||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.22||0.926|TWO_SIDED|95.0|-0.5|0.4|||Mixed linear model|||Statistical Analysis details presented here is for Sexual Desire Score, Week 8||0.4|-0.5|0.926
72514583|NCT03004469|144560013|OTHER||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.2||0.183|TWO_SIDED|95.0|-0.7|0.1|||Mixed linear model|||Statistical Analysis details presented here is for Sexual Desire Score, Week 12||0.1|-0.7|0.183
72514584|NCT03004469|144560013|OTHER||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.23||0.981|TWO_SIDED|95.0|-0.4|0.5|||Mixed linear model|||Statistical Analysis details presented here is for Sexual Desire Score, Week 24||0.5|-0.4|0.981
72403280|NCT03441633|144312225|SUPERIORITY||Odds Ratio (OR)|0.68||||0|TWO_SIDED|95.0|0.61|0.75|||Chi-squared|||Dabigatran vs. Apixaban in naive participants||0.75|0.61|0.000
72403281|NCT03441633|144312225|SUPERIORITY||Odds Ratio (OR)|0.85||||0.052|TWO_SIDED|95.0|0.63|1.15|||Chi-squared|||Dabigatran vs. Apixaban in non-naive participants||1.15|0.63|0.052
72403282|NCT03441633|144312225|SUPERIORITY||Odds Ratio (OR)|0.73||||0|TWO_SIDED|95.0|0.67|0.8|||Chi-squared|||Rivaroxaban vs. Apixaban in naive participants||0.80|0.67|0.000
72487727|NCT04223843|144504069|OTHER||Difference of adjusted means|0.321|STANDARD_ERROR_OF_MEAN|0.044|<|0.0001|TWO_SIDED|95.0|0.233|0.409|||ANCOVA|Model included the fixed categorical effect of treatment and the fixed continuous effect of baseline FEV1 AUC0-3h.|Difference = (Tio+Olo) - (Placebo)|H0: There is no difference in the mean FEV1 AUC0-3h change from baseline between Tio+Olo and matching placebo.||0.409|0.233|<0.0001
72487728|NCT04223843|144504070|OTHER||Difference of adjusted means|0.201|STANDARD_ERROR_OF_MEAN|0.043|<|0.0001|TWO_SIDED|95.0|0.117|0.286|||Mixed Models Analysis|Mixed model with repeated measures including fixed categorial effect of treatment at each visit and fixed continuous effect of baseline at each visit.|Difference = (Tio+Olo) - (Placebo)|H0: There is no difference in the mean trough FEV1 change from baseline between Tio+Olo and matching placebo.||0.286|0.117|<0.0001
72487729|NCT04223843|144504070|OTHER||Difference of adjusted means|0.217|STANDARD_ERROR_OF_MEAN|0.041|<|0.0001|TWO_SIDED|95.0|0.135|0.299|||Mixed Models Analysis|Mixed model with repeated measures including fixed categorial effect of treatment at each visit and fixed continuous effect of baseline at each visit.|Difference = (Tio+Olo) - (Placebo)|H0: There is no difference in the mean trough FEV1 change from baseline between Tio+Olo and matching placebo.||0.299|0.135|<0.0001
72487730|NCT00253643|144504071|SUPERIORITY_OR_OTHER|||||||0.1521|TWO_SIDED|||||Utilized a priori threshold for statistical significance of 0.05.|Mixed Models Analysis|||Mixed effects model to assess the effect time (pre vs. post) and treatment (GTFO, GT, FO and Placebo) on FAS summary scores||||0.1521
72487731|NCT00253643|144504072|SUPERIORITY_OR_OTHER|||||||0.1573|TWO_SIDED|||||A priori threshold for statistical significance is 0.05.|Mixed Models Analysis|||Mixed effects model to assess the effect of time (pre vs. post) and treatment (GTFO, GT, FO and Placebo) on Ki-67||||0.1573
72487732|NCT02636582|144504077|SUPERIORITY|||||||0.71|||||||Wilcoxon (Mann-Whitney)|||||||0.71
72487733|NCT02636582|144504078|SUPERIORITY|||||||0.964|||||||Wilcoxon (Mann-Whitney)|||||||0.964
72487734|NCT02636582|144504079|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||||||1
72487735|NCT02636582|144504080|OTHER|||||||0.172||||||HER2 expression - biopsy|Fisher Exact|||||||0.172
72487736|NCT02636582|144504080|OTHER|||||||0.38||||||HER2 expression - resection|Fisher Exact|||||||0.38
72487737|NCT01263483|144504087|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.002|||||TWO_SIDED|95.0|-1.166|-0.838||||||||-0.838|-1.166|
72514585|NCT03004469|144560013|OTHER||LS Mean Difference|-1.4|STANDARD_ERROR_OF_MEAN|0.66||0.041|TWO_SIDED|95.0|-2.7|-0.1|||Mixed linear model|||Statistical Analysis details presented here is for Intercourse Satisfaction Score, Week 4||-0.1|-2.7|0.041
72487738|NCT01263483|144504087|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.947|||||TWO_SIDED|95.0|-1.097|-0.796||||||||-0.796|-1.097|
72514586|NCT03004469|144560013|OTHER||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.67||0.562|TWO_SIDED|95.0|-1.7|0.9|||Mixed linear model|||Statistical Analysis details presented here is for Intercourse Satisfaction Score, Week 8||0.9|-1.7|0.562
72577095|NCT00580788|144680811|NON_INFERIORITY_OR_EQUIVALENCE|The study was designed as a standard dose-escalation study, dose-finding pilot study. The primary outcome measures were safety (hypercalcemia, hypophosphatemia and symptoms/hemodynamic measurements). A modified Fibronacci dose-escalation scheme was employed.||||||0.01|TWO_SIDED|||||the reported p value corresponds to a decrease by Day 8 compared to baseline in the PTHrP 4 pmol group|Mixed Models Analysis|The level of statistical significance was set at .05 (two-tailed)||||||0.01
72487739|NCT01263483|144504088|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.176|||||TWO_SIDED|95.0|-0.229|-0.123||||||||-0.123|-0.229|
72487740|NCT01263483|144504088|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.19|||||TWO_SIDED|95.0|-0.247|-0.133||||||||-0.133|-0.247|
72403283|NCT03441633|144312225|SUPERIORITY||Odds Ratio (OR)|0.79||||0.052|TWO_SIDED|95.0|0.61|1.03|||Chi-squared|||Rivaroxaban vs. Apixaban in non-naive participants||1.03|0.61|0.052
72403284|NCT03441633|144312225|SUPERIORITY||Odds Ratio (OR)|1.26||||0|TWO_SIDED|95.0|1.17|1.36|||Chi-squared|||Acenocumarol vs. Apixaban in naive participants||1.36|1.17|0.000
72403285|NCT03441633|144312225|SUPERIORITY||Odds Ratio (OR)|0.74||||0.052|TWO_SIDED|95.0|0.45|1.27|||Chi-squared|||Acenocumarol vs. Apixaban in non-naive participants||1.27|0.45|0.052
72487741|NCT01263483|144504089|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.421|||||TWO_SIDED|95.0|-0.507|-0.334||||||||-0.334|-0.507|
72487742|NCT01263483|144504089|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.414|||||TWO_SIDED|95.0|-0.504|-0.324||||||||-0.324|-0.504|
72487743|NCT01263483|144504090|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.738|||||TWO_SIDED|95.0|-0.871|-0.605||||||||-0.605|-0.871|
72487744|NCT01263483|144504090|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.749|||||TWO_SIDED|95.0|-0.875|-0.623||||||||-0.623|-0.875|
72487745|NCT01263483|144504091|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.01|||||TWO_SIDED|95.0|-18.5|-5.52||||||||-5.52|-18.50|
72487746|NCT01263483|144504091|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.33|||||TWO_SIDED|95.0|-21.93|-8.73||||||||-8.73|-21.93|
72487747|NCT01263483|144504092|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.65|||||TWO_SIDED|95.0|-23.02|-8.27||||||||-8.27|-23.02|
72487748|NCT01263483|144504092|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-22.03|||||TWO_SIDED|95.0|-29.68|-14.38||||||||-14.38|-29.68|
72487749|NCT01263483|144504093|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-18.3|||||TWO_SIDED|95.0|-26.09|-10.5||||||||-10.50|-26.09|
72487750|NCT01263483|144504093|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.34|||||TWO_SIDED|95.0|-27.34|-11.34||||||||-11.34|-27.34|
72514587|NCT03004469|144560013|OTHER||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.66||0.642|TWO_SIDED|95.0|-1.6|1.0|||Mixed linear model|||Statistical Analysis details presented here is for Intercourse Satisfaction Score, Week 12||1.0|-1.6|0.642
72514588|NCT03004469|144560013|OTHER||LS Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|0.65||0.156|TWO_SIDED|95.0|-2.2|0.4|||Mixed linear model|||Statistical Analysis details presented here is for Intercourse Satisfaction Score, Week 24||0.4|-2.2|0.156
72514589|NCT03004469|144560013|OTHER||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.29||0.824|TWO_SIDED|95.0|-0.6|0.5|||Mixed linear model|||Statistical Analysis details presented here is for Overall Satisfaction Score, Week 4||0.5|-0.6|0.824
72403286|NCT03441633|144312225|SUPERIORITY||Odds Ratio (OR)|1.07||||0|TWO_SIDED|95.0|0.95|1.21|||Chi-squared|||Warfarin vs. Apixaban in naive participants||1.21|0.95|0.000
72403287|NCT03441633|144312225|SUPERIORITY||Odds Ratio (OR)|0.57||||0.052|TWO_SIDED|95.0|0.4|0.84|||Chi-squared|||Warfarin vs. Apixaban in non-naive participants||0.84|0.40|0.052
72403288|NCT03441633|144312226|SUPERIORITY||Mean Difference (Final Values)|-0.22||||0|TWO_SIDED|95.0|-0.26|-0.17|||ANOVA|||Dabigatran vs. Apixaban in naive participants (HAS - BLED)||-0.17|-0.26|0.000
72403289|NCT03441633|144312226|SUPERIORITY||Mean Difference (Final Values)|-0.09||||0.001|TWO_SIDED|95.0|-0.18|-0.01|||ANOVA|||Dabigatran vs. Apixaban in non-naive participants (HAS - BLED)||-0.01|-0.18|0.001
72487751|NCT01263483|144504094|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.53|||||TWO_SIDED|95.0|-21.46|-5.6||||||||-5.60|-21.46|
72487752|NCT01263483|144504094|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.97|||||TWO_SIDED|95.0|-21.53|-4.41||||||||-4.41|-21.53|
72487753|NCT01263483|144504095|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|||||TWO_SIDED|95.0|-0.304|0.104||||||||0.104|-0.304|
72487754|NCT01263483|144504095|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.036|||||TWO_SIDED|95.0|-0.239|0.167||||||||0.167|-0.239|
72514590|NCT03004469|144560013|OTHER||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.29||0.713|TWO_SIDED|95.0|-0.5|0.7|||Mixed linear model|||Statistical Analysis details presented here is for Overall Satisfaction Score, Week 8||0.7|-0.5|0.713
72568027|NCT02037165|144667474|SUPERIORITY_OR_OTHER||Adjusted mean difference|-3.78|STANDARD_ERROR_OF_MEAN|2.5753|||TWO_SIDED|95.0|-8.9|1.3|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 0:30h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||1.3|-8.9|
72568028|NCT02037165|144667474|SUPERIORITY_OR_OTHER||Adjusted mean difference|-4.74|STANDARD_ERROR_OF_MEAN|2.5162|||TWO_SIDED|95.0|-9.8|0.3|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 1:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||0.3|-9.8|
72487755|NCT01263483|144504096|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.013|||||TWO_SIDED|95.0|-0.267|0.292||||||||0.292|-0.267|
72487756|NCT01263483|144504096|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.034|||||TWO_SIDED|95.0|-0.264|0.196||||||||0.196|-0.264|
72487757|NCT01263483|144504097|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.038|||||TWO_SIDED|95.0|-0.268|0.191||||||||0.191|-0.268|
72487758|NCT01263483|144504097|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.073|||||TWO_SIDED|95.0|-0.261|0.115||||||||0.115|-0.261|
72487759|NCT01263483|144504098|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.035|||||TWO_SIDED|95.0|-0.183|0.252||||||||0.252|-0.183|
72568029|NCT02037165|144667474|SUPERIORITY_OR_OTHER||Adjusted mean difference|-6.06|STANDARD_ERROR_OF_MEAN|2.9156|||TWO_SIDED|95.0|-11.9|-0.3|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 2:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||-0.3|-11.9|
72568030|NCT02037165|144667474|SUPERIORITY_OR_OTHER||Adjusted mean difference|-6.83|STANDARD_ERROR_OF_MEAN|3.4987|||TWO_SIDED|95.0|-13.8|0.1|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 3:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||0.1|-13.8|
72568031|NCT02037165|144667474|SUPERIORITY_OR_OTHER||Adjusted mean difference|-5.24|STANDARD_ERROR_OF_MEAN|3.6922|||TWO_SIDED|95.0|-12.6|2.1|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 4:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||2.1|-12.6|
72487760|NCT01263483|144504098|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.082|||||TWO_SIDED|95.0|-0.124|0.288||||||||0.288|-0.124|
72514591|NCT03004469|144560013|OTHER||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.3||0.993|TWO_SIDED|95.0|-0.6|0.6|||Mixed linear model|||Statistical Analysis details presented here is for Overall Satisfaction Score, Week 12||0.6|-0.6|0.993
72514592|NCT03004469|144560013|OTHER||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.3||0.55|TWO_SIDED|95.0|-0.8|0.4|||Mixed linear model|||Statistical Analysis details presented here is for Overall Satisfaction Score, Week 24||0.4|-0.8|0.550
72403290|NCT03441633|144312226|SUPERIORITY||Mean Difference (Final Values)|-0.19||||0|TWO_SIDED|95.0|-0.23|-0.15|||ANOVA|||Rivaroxaban vs. Apixaban in naive participants (HAS - BLED)||-0.15|-0.23|0.000
72403291|NCT03441633|144312226|SUPERIORITY||Mean Difference (Final Values)|-0.11||||0.001|TWO_SIDED|95.0|-0.19|-0.04|||ANOVA|||Rivaroxaban vs. Apixaban in non-naive participants (HAS - BLED)||-0.04|-0.19|0.001
72514593|NCT01940510|144560067|SUPERIORITY_OR_OTHER||Geometric Least Square Mean Ratio|26.8|||||TWO_SIDED|90.0|23.8|30.1|||||The reported values are percentages of geometric least square mean ratio.|Analysis of variance (ANOVA) was applied to the log-transformed PK parameters, and then back transformed to provide geometric least square mean ratios (Period 3/Period 1) and confidence intervals.||30.1|23.8|
72514594|NCT01940510|144560068|SUPERIORITY_OR_OTHER||Geometric Least Square Mean Ratio|48.6|||||TWO_SIDED|90.0|43.5|54.3|||||ANOVA was applied to the log-transformed PK parameters, and then back transformed to provide geometric least square mean ratios (Period 3/Period 1) and confidence intervals. The reported values are percentages of geometric least square mean ratio.|||54.3|43.5|
72514595|NCT01940510|144560069|SUPERIORITY_OR_OTHER||Geometric Least Square Mean Ratio|179.0|||||TWO_SIDED|90.0|158.0|202.0|||||ANOVA was applied to the log-transformed PK parameters, and then back transformed to provide geometric least square mean ratios (Period 3/Period 1) and confidence intervals. The reported values are percentages of geometric least square mean ratio.|||202|158|
72514596|NCT01940510|144560070|SUPERIORITY_OR_OTHER||Geometric Least Square Mean Ratio|220.0|||||TWO_SIDED|90.0|190.0|255.0|||||ANOVA was applied to the log-transformed PK parameters, and then back transformed to provide geometric least square mean ratios (Period 3/Period 1) and confidence intervals. The reported values are percentages of geometric least square mean ratio.|||255|190|
72514597|NCT02802878|144560097|SUPERIORITY|||||||0.67||||||Adjusted for two observations per subject.|Regression, Linear|Side treated as a repeated factor||||||.67
72514598|NCT01599754|144560102|SUPERIORITY||Hazard Ratio (HR)|0.87||||0.3211|TWO_SIDED|95.0|0.66|1.147|||Log Rank|||||1.147|0.660|0.3211
72514599|NCT01599754|144560103|SUPERIORITY||Hazard Ratio (HR)|1.026||||0.9246|TWO_SIDED|95.0|0.6|1.756|||Log Rank|||||1.756|0.600|0.9246
72514600|NCT01551758|144560125|SUPERIORITY_OR_OTHER||Adjusted treatment ratio|0.92|||=|0.025|TWO_SIDED|95.0|0.85|0.99|||Generalized Linear Model|||||0.99|0.85|=0.025
72514601|NCT01551758|144560126|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the upper limit of the two-sided 95% confidence interval for the incidence ratio is less than 2.|Incidence ratio|1.1|||||TWO_SIDED|95.0|0.9|1.5|||||Calculated as % of participants who had at least one SAE of pneumonia in the FF/VI group divided by the % of participants who had at least one SAE of pneumonia in the Usual Care group|||1.5|0.9|
72403292|NCT03441633|144312226|SUPERIORITY||Mean Difference (Final Values)|0.5||||0|TWO_SIDED|95.0|0.47|0.53|||ANOVA|||Acenocumarol vs. Apixaban in naive participants (HAS - BLED)||0.53|0.47|0.000
72403293|NCT03441633|144312226|SUPERIORITY||Mean Difference (Final Values)|-0.17||||0.001|TWO_SIDED|95.0|-0.32|-0.02|||ANOVA|||Acenocumarol vs. Apixaban in non-naive participants (HAS - BLED)||-0.02|-0.32|0.001
72403294|NCT03441633|144312226|SUPERIORITY||Mean Difference (Final Values)|0.17||||0|TWO_SIDED|95.0|0.12|0.23|||ANOVA|||Warfarin vs. Apixaban in naive participants (HAS - BLED)||0.23|0.12|0.000
72403295|NCT03441633|144312226|SUPERIORITY||Mean Difference (Final Values)|-0.24||||0.001|TWO_SIDED|95.0|-0.37|-0.1|||ANOVA|||Warfarin vs. Apixaban in non-naive participants (HAS - BLED)||-0.10|-0.37|0.001
72514602|NCT01551758|144560127|SUPERIORITY_OR_OTHER||Adjusted treatment ratio|1.08||||0.632|TWO_SIDED|95.0|0.79|1.47|||Generalized linear model|||||1.47|0.79|0.632
72514603|NCT01551758|144560128|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.13|||=|0.439|TWO_SIDED|95.0|0.83|1.52|||Cox proportional hazards model|||||1.52|0.83|=0.439
72514604|NCT01551758|144560129|SUPERIORITY_OR_OTHER||Adjusted treatment ratio|1.06||||0.488|TWO_SIDED|95.0|0.89|1.27|||Generalized linear model|||||1.27|0.89|0.488
72514605|NCT01551758|144560130|SUPERIORITY_OR_OTHER||Adjusted treatment ratio|0.98||||0.622|TWO_SIDED|95.0|0.92|1.05|||Generalized linear model|||||1.05|0.92|0.622
72514606|NCT01551758|144560131|SUPERIORITY_OR_OTHER||Adjusted treatment ratio|1.05||||0.336|TWO_SIDED|95.0|0.95|1.15|||Generalized Linear Model|||||1.15|0.95|0.336
72514607|NCT01551758|144560132|SUPERIORITY_OR_OTHER||Adjusted treatment ratio|1.12|||<|0.001|TWO_SIDED|95.0|1.05|1.2|||Generalized Linear Model|||||1.20|1.05|<0.001
72514608|NCT01551758|144560133|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.89|||<|0.001|TWO_SIDED|95.0|1.6|2.23|||Cox proportional hazards model||A hazard ratio \<1 indicates a lower risk with FF/VI compared with Usual Care.|||2.23|1.60|<0.001
72514609|NCT01551758|144560134|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.49|||<|0.001|TWO_SIDED|95.0|0.37|0.66|||Cox proprotional hazards model||A hazard ratio \<1 indicates a lower risk with FF/VI compared with Usual Care|||0.66|0.37|<0.001
72514610|NCT01551758|144560135|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.93||||0.111|TWO_SIDED|95.0|0.85|1.02|||Cox porportional hazards model||A hazard ratio \<1 indicates a lower risk with FF/VI compared with Usual Care|||1.02|0.85|0.111
72514611|NCT01551758|144560136|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.92||||0.081|TWO_SIDED|95.0|0.84|1.01|||Cox porportional hazards model|||||1.01|0.84|0.081
72514612|NCT01551758|144560137|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.27||||0.075|TWO_SIDED|95.0|0.98|1.66|||Cox proportional hazards model|||||1.66|0.98|0.075
72514613|NCT00906074|144560142|SUPERIORITY_OR_OTHER|||||||0.881|TWO_SIDED||||||Chi-squared|Chi-squared Pearson||Neoplasm||||0.881
72514614|NCT00906074|144560142|SUPERIORITY_OR_OTHER|||||||0.517|TWO_SIDED||||||Chi-squared|Chi-squared Pearson||Tobacco use||||0.517
72514615|NCT00906074|144560142|SUPERIORITY_OR_OTHER|||||||0.053|TWO_SIDED||||||Chi-squared|Chi-squared Pearson||BMI(kg/mˆ2)\>30||||0.053
72514616|NCT00906074|144560142|SUPERIORITY_OR_OTHER|||||||0.289|TWO_SIDED||||||Chi-squared|Chi-squared Pearson||Diabetes mellitus||||0.289
72514617|NCT00906074|144560142|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Chi-squared|Chi-squared Pearson||Immunosuppression/Corticosteroids||||1.000
72514618|NCT00906074|144560142|SUPERIORITY_OR_OTHER|||||||0.169|TWO_SIDED||||||Chi-squared|Chi-squared Pearson||Anemia (Hb\<9gr/dL)||||0.169
72514619|NCT00906074|144560142|SUPERIORITY_OR_OTHER|||||||0.637|TWO_SIDED||||||Chi-squared|Chi-squared Pearson||Malnutrition (hypoalbuminemia)||||0.637
72514620|NCT00906074|144560143|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Chi-squared|Chi-squared Pearson||||||1.000
72514621|NCT00906074|144560144|SUPERIORITY_OR_OTHER|||||||0.873|TWO_SIDED||||||Chi-squared|Chi-squared Pearson||||||0.873
72514622|NCT00906074|144560149|SUPERIORITY_OR_OTHER|||||||0.156|TWO_SIDED||||||Chi-squared|Chi-squared Pearson||||||0.156
72403296|NCT03441633|144312227|SUPERIORITY||Mean Difference (Final Values)|-0.18||||0|TWO_SIDED|95.0|-0.24|-0.12|||ANOVA|||Dabigatran vs. Apixaban in naive participants (CHADS2)||-0.12|-0.24|0.000
72403297|NCT03441633|144312227|SUPERIORITY||Mean Difference (Final Values)|-0.23||||0|TWO_SIDED|95.0|-0.35|-0.12|||ANOVA|||Dabigatran vs. Apixaban in non-naive participants (CHADS2)||-0.12|-0.35|0.000
72514623|NCT00906074|144560150|SUPERIORITY_OR_OTHER|||||||0.444|TWO_SIDED||||||Fisher Exact|||||||0.444
72514624|NCT00230100|144560243|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05|||||||Mixed Models Analysis|||"Implemented a general mixed model analysis of variance (MMANOVA), which models the means per group over the respective time period and the covariance between the repeated measures over the assessments. The MMANOVA approach estimates a separate mean for each phase of treatment per group. The MMANOVA is called a mixed model because it includes both fixed (e.g., treatment, gender) and random (subject-specific) terms. MMANOVA allows for randomly missing observations (not included in analysis)."||||<0.05
72514625|NCT00230100|144560244|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05|||||||Mixed Models Analysis|||"Implemented a general mixed model analysis of variance (MMANOVA), which models the means per group over the respective time period and the covariance between the repeated measures over the assessments. The MMANOVA approach estimates a separate mean for each phase of treatment per group. The MMANOVA is called a mixed model because it includes both fixed (e.g., treatment, gender) and random (subject-specific) terms. MMANOVA allows for randomly missing observations (not included in analysis)."||||<0.05
72514626|NCT00230100|144560245|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05|||||||Mixed Models Analysis|||"Implemented a general mixed model analysis of variance (MMANOVA), which models the means per group over the respective time period and the covariance between the repeated measures over the assessments. The MMANOVA approach estimates a separate mean for each phase of treatment per group. The MMANOVA is called a mixed model because it includes both fixed (e.g., treatment, gender) and random (subject-specific) terms. MMANOVA allows for randomly missing observations (not included in analysis)."||||<0.05
72403298|NCT03441633|144312227|SUPERIORITY||Mean Difference (Final Values)|-0.23||||0|TWO_SIDED|95.0|-0.28|-0.18|||ANOVA|||Rivaroxaban vs. Apixaban in naive participants (CHADS2)||-0.18|-0.28|0.000
72487761|NCT01263483|144504099|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-31.54|||||TWO_SIDED|95.0|-41.28|-21.8||||||||-21.80|-41.28|
72487762|NCT01263483|144504099|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-33.73|||||TWO_SIDED|95.0|-44.88|-22.57||||||||-22.57|-44.88|
72487763|NCT01263483|144504100|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-70.38|||||TWO_SIDED|95.0|-90.67|-50.09||||||||-50.09|-90.67|
72487764|NCT01263483|144504100|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-72.49|||||TWO_SIDED|95.0|-93.1|-51.88||||||||-51.88|-93.10|
72487765|NCT01263483|144504101|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.093|||||TWO_SIDED|95.0|2.229|11.958||||||||11.958|2.229|
72487766|NCT01263483|144504101|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.967|||||TWO_SIDED|95.0|-0.521|8.455||||||||8.455|-0.521|
72487767|NCT01263483|144504102|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.55|||||TWO_SIDED|95.0|-0.045|1.144||||||||1.144|-0.045|
72487768|NCT01263483|144504102|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.428|||||TWO_SIDED|95.0|-0.233|1.09||||||||1.090|-0.233|
72487769|NCT01263483|144504103|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-18.77|||||TWO_SIDED|95.0|-36.65|-0.9||||||||-0.90|-36.65|
72487770|NCT01263483|144504103|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-20.04|||||TWO_SIDED|95.0|-37.82|-2.27||||||||-2.27|-37.82|
72487771|NCT01372384|144504120|SUPERIORITY_OR_OTHER|||||||0.045|TWO_SIDED||||||"Clopper-Pearson exact method"|||Response assessment of Stable Disease Vs Partial Response at Visit 4 (Two proportions for Stable Disease Vs Partial Response of Erlotinib): The observed significance value of performed test for differences between two proportions for Stable Disease Vs Partial Response was analyzed.||||0.045
72487772|NCT01372384|144504120|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||"Clopper-Pearson exact method"|||Response assessment of Stable Disease Vs Partial Response at Visit 6 (Two proportions for Stable Disease Vs Partial Response of Erlotinib): The observed significance value of performed test for differences between two proportions for Stable Disease Vs Partial Response was analyzed||||1.000
72487773|NCT01372384|144504120|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||"Clopper-Pearson exact method"|||Response assessment of Partial Response Vs Progression of disease at Visit 6 (Two proportions for of Partial Response Vs Progression of disease of Erlotinib): The observed significance value of performed test for differences between two proportions for of Partial Response Vs Progression of disease was analyzed||||1.000
72487774|NCT01372384|144504120|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||"Clopper-Pearson exact method"|||Response assessment of Stable Disease Vs Progression of disease at Visit 6 (Two proportions for of Stable Disease Vs Progression of disease of Erlotinib): The observed significance value of performed test for differences between two proportions for of Stable Disease Vs Progression of disease was analyzed||||1.000
72487775|NCT01372384|144504120|SUPERIORITY_OR_OTHER|||||||0.274|TWO_SIDED||||||"Clopper-Pearson exact method"|||Response assessment of Partial Response Vs Progression of disease at Visit 10 (Two proportions for of Partial Response Vs Progression of disease of Erlotinib): The observed significance value of performed test for differences between two proportions for of Partial Response Vs Progression of disease was analyzed||||0.274
72487776|NCT01131676|144504127|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin was chosen as 1.3 based on Food and Drug Administration (FDA) Guidance for Industry - Diabetes Mellitus - Evaluating Cardiovascular Risk in New Antidiabetic Therapies to Treat Type 2 Diabetes|Hazard Ratio (HR)|0.86|||<|0.0001|TWO_SIDED|95.02|0.74|0.99||One-sided test with alpha = 0.0249|Cox proportional hazards model|Cox proportional hazards model with factors for treatment, age, gender, categorised BMI, HbA1c, eGFR and geographical region.|All Empagliflozin divided by Placebo|Primary objective was to establish the non-inferiority of All empagliflozin relative to placebo for time to first 3-point MACE. A 4-step hierarchical testing strategy was followed for the non-inferiority test of the primary endpoint and then the key secondary endpoint, each at a margin of 1.3, followed by test of superiority of primary and key secondary endpoints.||0.99|0.74|<0.0001
72487777|NCT01131676|144504127|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.86||||0.0382|TWO_SIDED|95.02|0.74|0.99||Two-sided test with alpha=0.0498|Cox proportional hazards model|Cox proportional hazards model with factors for treatment, age, gender, categorised BMI, HbA1c, eGFR and geographical region.|All Empagliflozin divided by Placebo|||0.99|0.74|0.0382
72568032|NCT02037165|144667474|SUPERIORITY_OR_OTHER||Adjusted mean difference|-4.71|STANDARD_ERROR_OF_MEAN|3.6166|||TWO_SIDED|95.0|-11.9|2.5|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 5:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||2.5|-11.9|
72568033|NCT02037165|144667474|SUPERIORITY_OR_OTHER||Adjusted mean difference|-3.09|STANDARD_ERROR_OF_MEAN|3.7073|||TWO_SIDED|95.0|-10.5|4.3|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 6:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||4.3|-10.5|
72568034|NCT02037165|144667474|SUPERIORITY_OR_OTHER||Adjusted mean difference|-3.82|STANDARD_ERROR_OF_MEAN|4.186|||TWO_SIDED|95.0|-12.1|4.5|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 22:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||4.5|-12.1|
72568035|NCT02037165|144667474|SUPERIORITY_OR_OTHER||Adjusted mean difference|-2.67|STANDARD_ERROR_OF_MEAN|3.4254|||TWO_SIDED|95.0|-9.5|4.1|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 24:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||4.1|-9.5|
72568036|NCT02037165|144667474|SUPERIORITY_OR_OTHER||Adjusted mean difference|-3.64|STANDARD_ERROR_OF_MEAN|2.5461|||TWO_SIDED|95.0|-8.7|1.4|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 0:30h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||1.4|-8.7|
72568037|NCT02037165|144667474|SUPERIORITY_OR_OTHER||Adjusted mean difference|-2.46|STANDARD_ERROR_OF_MEAN|2.4848|||TWO_SIDED|95.0|-7.4|2.5|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 1:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||2.5|-7.4|
72568038|NCT02037165|144667474|SUPERIORITY_OR_OTHER||Adjusted mean difference|-3.27|STANDARD_ERROR_OF_MEAN|2.8811|||TWO_SIDED|95.0|-9.0|2.5|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 2:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||2.5|-9.0|
72514627|NCT00230100|144560246|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05|||||||Mixed Models Analysis|||It was hypothesized that the single-gender group composition and women-focused group content (WRG) would result in better substance abuse treatment outcomes (lower ASI alcohol composite scores) than standard mixed-gender group treatment (GDC).||||<0.05
72514628|NCT00230100|144560247|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.009|||||||Mixed Models Analysis|||||||<0.009
72514629|NCT01906866|144560257|SUPERIORITY||Mean Difference (Final Values)|32.32|STANDARD_ERROR_OF_MEAN|15.1|=|0.035|TWO_SIDED|95.0|2.38|62.26|||Mixed Models Analysis|||||62.26|2.38|=0.035
72514630|NCT01906866|144560258|SUPERIORITY||Mean Difference (Final Values)|-25.2|STANDARD_ERROR_OF_MEAN|9.787|=|0.011|TWO_SIDED|95.0|-44.61|-5.8|||Mixed Models Analysis|||||-5.8|-44.61|=0.011
72514631|NCT01906866|144560261|SUPERIORITY|||||||0.053|||||||MMRM|||Mixed Models for Repeated Measures (MMRM) analysis||||0.053
72514632|NCT01906866|144560261|SUPERIORITY|||||||0.039|||||||MI analysis|||||||0.039
72514633|NCT01906866|144560263|SUPERIORITY|||||||0.077|||||||MMRM|||||||0.077
72514634|NCT01906866|144560264|SUPERIORITY|||||||0.04|||||||Chi-squared|||||||0.04
72514635|NCT00438399|144560271|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0003||95.0|||||Wilcoxon (Mann-Whitney)|||The purpose of the study was to demonstrate the superiority of Clobetasol propionate shampoo over one of three other comparators, in terms of Subject's overall preference. It was to be analyzed using a non parametric two-sided Wilcoxon rank Signed test on ITT population.||||0.0003
72514636|NCT00438399|144560271|SUPERIORITY_OR_OTHER_LEGACY|||||||0.007||95.0|||||Wilcoxon (Mann-Whitney)|||The purpose of the study was to demonstrate the superiority of Clobetasol propionate shampoo over one of three other comparators, in terms of Subject's overall preference. It was to be analyzed using a non parametric two-sided Wilcoxon rank Signed test on ITT population.||||0.007
72403299|NCT03441633|144312227|SUPERIORITY||Mean Difference (Final Values)|-0.21||||0|TWO_SIDED|95.0|-0.31|-0.11|||ANOVA|||Rivaroxaban vs. Apixaban in non-naive participants (CHADS2)||-0.11|-0.31|0.000
72403300|NCT03441633|144312227|SUPERIORITY||Mean Difference (Final Values)|0.21||||0|TWO_SIDED|95.0|0.17|0.25|||ANOVA|||Acenocumarol vs. Apixaban in naive participants (CHADS2)||0.25|0.17|0.000
72403301|NCT03441633|144312227|SUPERIORITY||Mean Difference (Final Values)|-0.5||||0|TWO_SIDED|95.0|-0.7|-0.3|||ANOVA|||Acenocumarol vs. Apixaban in non-naive participants (CHADS2)||-0.30|-0.70|0.000
72403302|NCT03441633|144312227|SUPERIORITY||Mean Difference (Final Values)|0.08||||0|TWO_SIDED|95.0|0.01|0.14|||ANOVA|||Warfarin vs. Apixaban in naive participants (CHADS2)||0.14|0.01|0.000
72403303|NCT03441633|144312227|SUPERIORITY||Mean Difference (Final Values)|-0.37||||0|TWO_SIDED|95.0|-0.54|-0.2|||ANOVA|||Warfarin vs. Apixaban in non-naive participants (CHADS2)||-0.20|-0.54|0.000
72403304|NCT03441633|144312228|SUPERIORITY||Mean Difference (Final Values)|-0.34||||0|TWO_SIDED|95.0|-0.42|-0.26|||ANOVA|||Dabigatran vs. Apixaban in naive participants (CHA2DS2Vasc)||-0.26|-0.42|0.000
72403305|NCT03441633|144312228|SUPERIORITY||Mean Difference (Final Values)|-0.33||||0|TWO_SIDED|95.0|-0.46|-0.19|||ANOVA|||Dabigatran vs. Apixaban in non-naive participants (CHA2DS2Vasc)||-0.19|-0.46|0.000
72403306|NCT03441633|144312228|SUPERIORITY||Mean Difference (Final Values)|-0.38||||0|TWO_SIDED|95.0|-0.45|-0.32|||ANOVA|||Rivaroxaban vs. Apixaban in naive participants (CHA2DS2Vasc)||-0.32|-0.45|0.000
72514637|NCT00438399|144560271|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||Wilcoxon (Mann-Whitney)|||The purpose of the study was to demonstrate the superiority of Clobetasol propionate shampoo over one of three other comparators, in terms of Subject's overall preference. It was to be analyzed using a non parametric two-sided Wilcoxon rank Signed test on ITT population.||||<0.0001
72568039|NCT02037165|144667474|SUPERIORITY_OR_OTHER||Adjusted mean difference|-2.91|STANDARD_ERROR_OF_MEAN|3.4569|||TWO_SIDED|95.0|-9.8|4.0|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 3:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||4.0|-9.8|
72403307|NCT03441633|144312228|SUPERIORITY||Mean Difference (Final Values)|-0.27||||0|TWO_SIDED|95.0|-0.39|-0.15|||ANOVA|||Rivaroxaban vs. Apixaban in non-naive participants (CHA2DS2Vasc)||-0.15|-0.39|0.000
72403308|NCT03441633|144312228|SUPERIORITY||Mean Difference (Final Values)|0.19||||0|TWO_SIDED|95.0|0.14|0.24|||ANOVA|||Acenocumarol vs. Apixaban in naive participants (CHA2DS2Vasc)||0.24|0.14|0.000
72403309|NCT03441633|144312228|SUPERIORITY||Mean Difference (Final Values)|-0.62||||0|TWO_SIDED|95.0|-0.86|-0.37|||ANOVA|||Acenocumarol vs. Apixaban in non-naive participants (CHA2DS2Vasc)||-0.37|-0.86|0.000
72403310|NCT03441633|144312228|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0|TWO_SIDED|95.0|-0.18|-0.01|||ANOVA|||Warfarin vs. Apixaban in naive participants (CHA2DS2Vasc)||-0.01|-0.18|0.000
72403311|NCT03441633|144312228|SUPERIORITY||Mean Difference (Final Values)|-0.43||||0|TWO_SIDED|95.0|-0.64|-0.21|||ANOVA|||Warfarin vs. Apixaban in non-naive participants (CHA2DS2Vasc)||-0.21|-0.64|0.000
72403312|NCT03441633|144312229|SUPERIORITY||Odds Ratio (OR)|1.88||||0.008|TWO_SIDED|95.0|0.77|5.3|||Chi-squared|||Dabigatran vs. Apixaban in non-naive participants||5.30|0.77|0.008
72403313|NCT03441633|144312229|SUPERIORITY||Odds Ratio (OR)|0.62||||0.008|TWO_SIDED|95.0|0.33|1.12|||Chi-squared|||Rivaroxaban vs. Apixaban in non-naive participants||1.12|0.33|0.008
72403314|NCT03441633|144312229|SUPERIORITY||Odds Ratio (OR)|0.55||||0.008|TWO_SIDED|95.0|0.2|1.99|||Chi-squared|||Acenocumarol vs. Apixaban in non-naive participants||1.99|0.20|0.008
72403315|NCT03441633|144312229|SUPERIORITY||Odds Ratio (OR)|0.39||||0.008|TWO_SIDED|95.0|0.18|0.86|||Chi-squared|||Warfarin vs. Apixaban in non-naive participants||0.86|0.18|0.008
72403316|NCT03441633|144312230|SUPERIORITY||Odds Ratio (OR)|1.41||||0|TWO_SIDED|95.0|1.14|1.75|||Chi-squared|||Dabigatran vs. Apixaban in naive participants (Poor adherence)||1.75|1.14|0.000
72403317|NCT03441633|144312230|SUPERIORITY||Odds Ratio (OR)|0.67||||0|TWO_SIDED|95.0|0.55|0.82|||Chi-squared|||Dabigatran vs. Apixaban in naive participants (Good adherence)||0.82|0.55|0.000
72403318|NCT03441633|144312230|SUPERIORITY||Odds Ratio (OR)|0.1||||0|TWO_SIDED|95.0|0.03|2.01|||Chi-squared|||Dabigatran vs. Apixaban in naive participants (Over adherence)||2.01|0.03|0.000
72403319|NCT03441633|144312230|SUPERIORITY||Odds Ratio (OR)|1.58||||0|TWO_SIDED|95.0|1.23|2.04|||Chi-squared|||Dabigatran vs. Apixaban in non-naive participants (Poor adherence)||2.04|1.23|0.000
72403320|NCT03441633|144312230|SUPERIORITY||Odds Ratio (OR)|0.44||||0|TWO_SIDED|95.0|0.34|0.57|||Chi-squared|||Dabigatran vs. Apixaban in non-naive participants (Good adherence)||0.57|0.34|0.000
72403321|NCT03441633|144312230|SUPERIORITY||Odds Ratio (OR)|0.43||||0|TWO_SIDED|95.0|0.02|3.73|||Chi-squared|||Dabigatran vs. Apixaban in non-naive participants (Over adherence)||3.73|0.02|0.000
72403322|NCT03441633|144312230|SUPERIORITY||Odds Ratio (OR)|0.66||||0|TWO_SIDED|95.0|0.52|0.84|||Chi-squared|||Rivaroxaban vs. Apixaban in naive participants (Poor adherence)||0.84|0.52|0.000
72403323|NCT03441633|144312230|SUPERIORITY||Odds Ratio (OR)|1.14||||0|TWO_SIDED|95.0|0.95|1.36|||Chi-squared|||Rivaroxaban vs. Apixaban in naive participants (Good adherence)||1.36|0.95|0.000
72403324|NCT03441633|144312230|SUPERIORITY||Odds Ratio (OR)|0.52||||0|TWO_SIDED|95.0|0.06|3.41|||Chi-squared|||Rivaroxaban vs. Apixaban in naive participants (Over adherence)||3.41|0.06|0.000
72403325|NCT03441633|144312230|SUPERIORITY||Odds Ratio (OR)|0.65||||0|TWO_SIDED|95.0|0.5|0.85|||Chi-squared|||Rivaroxaban vs. Apixaban in non-naive participants (Poor adherence)||0.85|0.50|0.000
72403326|NCT03441633|144312230|SUPERIORITY||Odds Ratio (OR)|1.11||||0|TWO_SIDED|95.0|0.9|1.37|||Chi-squared|||Rivaroxaban vs. Apixaban in non-naive participants (Good adherence)||1.37|0.90|0.000
72514638|NCT00723073|144560272|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.99|STANDARD_DEVIATION|1.0||0.96|TWO_SIDED|95.0|0.89|1.1|||Fisher Exact|||||1.10|0.89|0.96
72514639|NCT00723073|144560273|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.0|STANDARD_DEVIATION|1.0|>|0.99|TWO_SIDED|95.0|0.38|2.7|||Fisher Exact|||||2.70|0.38|>0.99
72514640|NCT00723073|144560274|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.93|STANDARD_DEVIATION|1.0|>|0.99|TWO_SIDED|95.0|0.44|1.97|||Fisher Exact|||||1.97|0.44|>0.99
72568040|NCT02037165|144667474|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.27|STANDARD_ERROR_OF_MEAN|3.6471|||TWO_SIDED|95.0|-7.0|7.5|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 4:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||7.5|-7.0|
72568041|NCT02037165|144667474|SUPERIORITY_OR_OTHER||Adjusted mean difference|-2.27|STANDARD_ERROR_OF_MEAN|3.5708|||TWO_SIDED|95.0|-9.4|4.8|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 5:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||4.8|-9.4|
72568042|NCT02037165|144667474|SUPERIORITY_OR_OTHER||Adjusted mean difference|-4.21|STANDARD_ERROR_OF_MEAN|3.6602|||TWO_SIDED|95.0|-11.5|3.1|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 6:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||3.1|-11.5|
72403327|NCT03441633|144312230|SUPERIORITY||Odds Ratio (OR)|1.07||||0|TWO_SIDED|95.0|0.22|5.85|||Chi-squared|||Rivaroxaban vs. Apixaban in non-naive participants (Over adherence)||5.85|0.22|0.000
72403328|NCT03441633|144312230|SUPERIORITY||Odds Ratio (OR)|3.37||||0|TWO_SIDED|95.0|2.86|3.99|||Chi-squared|||Acenocumarol vs. Apixaban in naive participants (Poor adherence)||3.99|2.86|0.000
72514641|NCT00723073|144560275|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.12|STANDARD_DEVIATION|1.0||0.48|TWO_SIDED|95.0|0.61|2.07|||Fisher Exact|||||2.07|0.61|0.48
72514642|NCT00723073|144560276|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.57|STANDARD_DEVIATION|1.0||0.57|TWO_SIDED|95.0|0.1|3.37|||Fisher Exact|||||3.37|0.10|0.57
72514643|NCT00723073|144560277|SUPERIORITY_OR_OTHER|||||||0.66||95.0|||||Chi-squared|||||||0.66
72514644|NCT00723073|144560280|SUPERIORITY_OR_OTHER|||||||0.22||95.0|||||Fisher Exact|||||||0.22
72514645|NCT00723073|144560281|SUPERIORITY_OR_OTHER|||||||0.11||95.0|||||Fisher Exact|||||||0.11
72514646|NCT01927419|144560307|SUPERIORITY||Mean Difference (Final Values)|49.5|||||TWO_SIDED|95.0|31.4|61.8|||Fisher Exact||Difference of ORR||Exact 95% CI for difference in ORR uses Newcombe's method|61.8|31.4|
72514647|NCT01927419|144560307|SUPERIORITY||Odds Ratio (OR)|12.52|||||TWO_SIDED|95.0|3.79|52.55|||Fisher Exact|||||52.55|3.79|
72514648|NCT01927419|144560308|SUPERIORITY||Hazard Ratio (HR)|0.36|||||TWO_SIDED|95.0|0.21|0.59|||Unstratified Cox proportional hazard||Nivolumab + Ipilimumab over Ipilimumab|||0.59|0.21|
72514649|NCT01927419|144560309|SUPERIORITY||Mean Difference (Final Values)|44.5|||||TWO_SIDED|95.0|8.2|64.8|||Fisher Exact||Difference of ORR||Exact 95% CI for difference in ORR uses Newcombe's method|64.8|8.2|
72514650|NCT01927419|144560309|SUPERIORITY||Odds Ratio (OR)|10.8|||||TWO_SIDED|95.0|1.07|511.89|||Fisher Exact|||||511.89|1.07|
72514651|NCT01927419|144560310|SUPERIORITY||Hazard Ratio (HR)|0.36|||||TWO_SIDED|95.0|0.14|0.97|||Unstratified Cox proportional hazard||Nivolumab + Ipilimumab over Ipilimumab|||0.97|0.14|
72514652|NCT00592553|144560336|OTHER||Least Square (LS) Mean Difference|-30.52|STANDARD_ERROR_OF_MEAN|42.68||0.4756|TWO_SIDED|95.0|-114.8|53.75|||Mixed Models Analysis|||Analysis was performed using mixed model for repeated measures (MMRM) method including rank transformed 6MWD as the dependent variable; and rank transformed baseline 6MWD, treatment, visit, age (less than \[\<\] 9 years versus \[vs.\] greater than or equal to \[\>=\] 9 years) and corticosteroid use (yes vs. no) stratification factors, and interaction between treatment and visit as independent variables.||53.75|-114.8|0.4756
72514653|NCT00592553|144560336|OTHER||LS Mean Difference|62.65|STANDARD_ERROR_OF_MEAN|43.21||0.149|TWO_SIDED|95.0|-22.66|147.96|||Mixed Models Analysis|||Analysis was performed using MMRM method including rank transformed 6MWD as the dependent variable; and rank transformed baseline 6MWD, treatment, visit, age (\< 9 years vs. \>= 9 years) and corticosteroid use (yes vs. no) stratification factors, and interaction between treatment and visit as independent variables.||147.96|-22.66|0.1490
72514654|NCT01244191|144560377|SUPERIORITY||Hazard Ratio (HR)|0.981||||0.8086|TWO_SIDED|95.0|0.841|1.149|||Log Rank||Hazard ratio and the 95% confidence interval from stratified Cox-regression model (adjusting for number of prior therapies, gender, and smoking history).|||1.149|0.841|0.8086
72514655|NCT01511107|144560388|NON_INFERIORITY_OR_EQUIVALENCE|A noninferiority margin of 10% was used. Non-inferiority can be established by placing a confidence interval on the difference in the proportion of TFs in subjects randomized to the 10 day regimen and the proportion of TFs in subjects randomized to the 5 day regimen, and determining whether the lower 95% confidence bound is greater than -10%.|Difference between proportions|-0.172|STANDARD_DEVIATION|0.039|||TWO_SIDED|95.0|-0.253|-0.091||||||The null hypothesis that amoxicillin-clavulanate 5 days, placebo 5 days (reduced duration) is inferior to amoxicillin-clavulanate 10 days (standard duration) is tested against the alternative that reduced duration treatment is noninferior. Assuming failure rates of 15% and 25% in the standard and reduced duration groups, respectively, a 2-sided significance level of .05 and 10% attrition, it was calculated that 300 participants per group, would provide power of 95% for finding inferiority.||-.091|-.253|
72514656|NCT01511107|144560389|NON_INFERIORITY_OR_EQUIVALENCE|A noninferiority margin of 10% was used. Non-inferiority can be established by placing a confidence interval on the difference in the proportion of TFs in subjects randomized to the 10 day regimen and the proportion of TFs in subjects randomized to the 5 day regimen, and determining whether the lower 95% confidence bound is greater than -10%.|Difference between proportions|-0.096|STANDARD_DEVIATION|0.053|||TWO_SIDED|95.0|-0.209|0.016||||||||.016|-.209|
72403329|NCT03441633|144312230|SUPERIORITY||Odds Ratio (OR)|0.11||||0|TWO_SIDED|95.0|0.09|0.13|||Chi-squared|||Acenocumarol vs. Apixaban in naive participants (Good adherence)||0.13|0.09|0.000
72403330|NCT03441633|144312230|SUPERIORITY||Odds Ratio (OR)|0.34||||0|TWO_SIDED|95.0|0.11|1.52|||Chi-squared|||Acenocumarol vs. Apixaban in naive participants (Over adherence)||1.52|0.11|0.000
72403331|NCT03441633|144312230|SUPERIORITY||Odds Ratio (OR)|1.23||||0|TWO_SIDED|95.0|0.78|1.91|||Chi-squared|||Acenocumarol vs. Apixaban in non-naive participants (Poor adherence)||1.91|0.78|0.000
72403332|NCT03441633|144312230|SUPERIORITY||Odds Ratio (OR)|0.01||||0|TWO_SIDED|95.0|0.0|0.09|||Chi-squared|||Acenocumarol vs. Apixaban in non-naive participants (Good adherence)||0.09|0.00|0.000
72403333|NCT03441633|144312230|SUPERIORITY||Odds Ratio (OR)|2.07||||0|TWO_SIDED|95.0|0.07|18.0|||Chi-squared|||Acenocumarol vs. Apixaban in non-naive participants (Over adherence)||18.00|0.07|0.000
72403334|NCT03441633|144312230|SUPERIORITY||Odds Ratio (OR)|0.58||||0|TWO_SIDED|95.0|0.45|0.75|||Chi-squared|||Warfarin vs. Apixaban in naive participants (Poor adherence)||0.75|0.45|0.000
72514657|NCT01511107|144560390|SUPERIORITY_OR_OTHER|||||||0.45|||||||Regression, Logistic|||Null hypothesis: There is no difference between the two groups in the proportion of children whose NP isolates at enrollment are negative for AOM pathogens for whom the NP culture at day 12-14 yields a nonsusceptible pathogen.||||0.45
72514658|NCT01511107|144560391|SUPERIORITY_OR_OTHER|||||||0.95|||||||Generalized estimating equations|||Null hypothesis: For AOM recurrences with a NP culture at onset that is negative for AOM pathogens, there is no difference between the two groups regarding the proportion of NP cultures at Day 12-14 that yield a nonsusceptible pathogen.||||0.95
72403335|NCT03441633|144312230|SUPERIORITY||Odds Ratio (OR)|0.51||||0|TWO_SIDED|95.0|0.41|0.63|||Chi-squared|||Warfarin vs. Apixaban in naive participants (Good adherence)||0.63|0.41|0.000
72403336|NCT03441633|144312230|SUPERIORITY||Odds Ratio (OR)|29.4||||0|TWO_SIDED|95.0|11.01|123.8|||Chi-squared|||Warfarin vs. Apixaban in naive participants (Over adherence)||123.80|11.01|0.000
72403337|NCT03441633|144312230|SUPERIORITY||Odds Ratio (OR)|1.31||||0|TWO_SIDED|95.0|0.91|1.86|||Chi-squared|||Warfarin vs. Apixaban in non-naive participants (Poor adherence)||1.86|0.91|0.000
72403338|NCT03441633|144312230|SUPERIORITY||Odds Ratio (OR)|0.1||||0|TWO_SIDED|95.0|0.05|0.17|||Chi-squared|||Warfarin vs. Apixaban in non-naive participants (Good adherence)||0.17|0.05|0.000
72403339|NCT03441633|144312230|SUPERIORITY||Odds Ratio (OR)|9.73||||0|TWO_SIDED|95.0|2.81|46.5|||Chi-squared|||Warfarin vs. Apixaban in non-naive participants (Over adherence)||46.50|2.81|0.000
72403340|NCT03441633|144312231|SUPERIORITY||Odds Ratio (OR)|1.08||||0|TWO_SIDED|95.0|0.92|1.27|||Chi-squared|||Dabigatran vs. Apixaban in naive participants (Discontinuation first year)||1.27|0.92|0.000
72403341|NCT03441633|144312231|SUPERIORITY||Odds Ratio (OR)|1.45||||0|TWO_SIDED|95.0|1.15|1.83|||Chi-squared|||Dabigatran vs. Apixaban in non-naive participants (Discontinuation first year)||1.83|1.15|0.000
72403342|NCT03441633|144312231|SUPERIORITY||Odds Ratio (OR)|1.09||||0|TWO_SIDED|95.0|0.93|1.27|||Chi-squared|||Rivaroxaban vs. Apixaban in naive participants (Discontinuation first year)||1.27|0.93|0.000
72403343|NCT03441633|144312231|SUPERIORITY||Odds Ratio (OR)|1.18||||0|TWO_SIDED|95.0|0.96|1.47|||Chi-squared|||Rivaroxaban vs. Apixaban in non-naive participants (Discontinuation first year)||1.47|0.96|0.000
72403344|NCT03441633|144312231|SUPERIORITY||Odds Ratio (OR)|0.89||||0|TWO_SIDED|95.0|0.79|1.01|||Chi-squared|||Acenocumarol vs. Apixaban in naive participants (Discontinuation first year)||1.01|0.79|0.000
72403345|NCT03441633|144312231|SUPERIORITY||Odds Ratio (OR)|4.82||||0|TWO_SIDED|95.0|3.14|7.55|||Chi-squared|||Acenocumarol vs. Apixaban in non-naive participants (Discontinuation first year)||7.55|3.14|0.000
72487778|NCT01131676|144504128|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin was chosen as 1.3 based on Food and Drug Administration (FDA) Guidance for Industry - Diabetes Mellitus - Evaluating Cardiovascular Risk in New Antidiabetic Therapies to Treat Type 2 Diabetes|Hazard Ratio (HR)|0.89|||<|0.0001|TWO_SIDED|95.02|0.78|1.01||One-sided test with alpha = 0.0249|Cox proportional hazards model|Cox proportional hazards model with factors for treatment, age, gender, categorised BMI, HbA1c, eGFR and geographical region.|All Empagliflozin divided by Placebo|A 4-step hierarchical testing strategy was followed for the non-inferiority test of the primary endpoint and then the key secondary endpoint, each at a margin of 1.3, followed by test of superiority of primary and key secondary endpoints.||1.01|0.78|<0.0001
72514659|NCT01511107|144560392|SUPERIORITY_OR_OTHER|||||||0.59|||||||Regression, Logistic|||Null hypothesis: There is no difference between the two groups in the proportion of children whose NP isolates at enrollment are positive only for one or more susceptible pathogens for whom the NP culture at day 12-14 yields a nonsusceptible pathogen.||||0.59
72514660|NCT01511107|144560393|SUPERIORITY_OR_OTHER||||||>|0.99|||||||Generalized estimating equations|||Null hypothesis: For AOM recurrences with a NP culture at onset that is positive only for one or more susceptible pathogens, there is no difference between the two groups regarding the proportion of NP cultures at Day 12-14 that yield a nonsusceptible pathogen.||||>0.99
72403346|NCT03441633|144312231|SUPERIORITY||Odds Ratio (OR)|1.41||||0|TWO_SIDED|95.0|1.19|1.67|||Chi-squared|||Warfarin vs. Apixaban in naive participants (Discontinuation first year)||1.67|1.19|0.000
72403347|NCT03441633|144312231|SUPERIORITY||Odds Ratio (OR)|2.92||||0|TWO_SIDED|95.0|2.12|4.05|||Chi-squared|||Warfarin vs. Apixaban in non-naive participants (Discontinuation first year)||4.05|2.12|0.000
72403348|NCT03441633|144312232|SUPERIORITY||Mean Difference (Final Values)|3.63||||0|TWO_SIDED|95.0|3.02|4.24|||ANOVA|||Dabigatran vs. Apixaban in naive participants (NDDDs)||4.24|3.02|0.000
72403349|NCT03441633|144312232|SUPERIORITY||Mean Difference (Final Values)|0.11||||0|TWO_SIDED|95.0|-0.77|0.98|||ANOVA|||Dabigatran vs. Apixaban in non-naive participants (NDDDs)||0.98|-0.77|0.000
72403350|NCT03441633|144312232|SUPERIORITY||Mean Difference (Final Values)|1.51||||0|TWO_SIDED|95.0|0.84|2.17|||ANOVA|||Rivaroxaban vs. Apixaban in naive participants (NDDDs)||2.17|0.84|0.000
72403351|NCT03441633|144312232|SUPERIORITY||Mean Difference (Final Values)|1.98||||0|TWO_SIDED|95.0|1.16|2.8|||ANOVA|||Rivaroxaban vs. Apixaban in non-naive participants (NDDDs)||2.80|1.16|0.000
72403352|NCT03441633|144312232|SUPERIORITY||Mean Difference (Final Values)|0.9||||0|TWO_SIDED|95.0|0.41|1.39|||ANOVA|||Acenocumarol vs. Apixaban in naive participants (NDDDs)||1.39|0.41|0.000
72514661|NCT01511107|144560394|SUPERIORITY_OR_OTHER|||||||0.47|||||||Regression, Logistic|||Null hypothesis: There is no difference between the two groups in the proportion of children whose NP isolates at enrollment are positive for one or more nonsusceptible pathogens for whom the NP culture at day 12-14 yields a nonsusceptible pathogen.||||0.47
72514662|NCT01511107|144560395|SUPERIORITY_OR_OTHER|||||||0.05|||||||Generalized estimating equations|||Null hypothesis: For AOM recurrences with a NP culture at onset that is positive for one or more nonsusceptible pathogens, there is no difference between the two groups regarding the proportion of NP cultures at Day 12-14 that yield a nonsusceptible pathogen.||||0.05
72514663|NCT01511107|144560396|SUPERIORITY_OR_OTHER|||||||0.58|||||||Regression, Logistic|The p-value is adjusted for the culture result at enrollment.||Null hypothesis: There is no difference in the proportion of subjects whose NP isolates at enrollment are pathogen-negative or positive only for at least one susceptible pathogen who become colonized with penicillin non-susceptible pathogens at any time over the course of follow-up||||0.58
72514664|NCT01511107|144560397|SUPERIORITY_OR_OTHER|||||||0.74|||||||Generalized estimating equations|||Null hypothesis: There is no difference in the proportion of 6 week follow-up, non-illness visits at which a penicillin-nonsusceptible pathogen is recovered.||||0.74
72514665|NCT01511107|144560398|SUPERIORITY_OR_OTHER|||||||0.72|||||||Regression, Logistic|The p-value is adjusted for S pn susceptibility at the index episode.||Null hypothesis: There is no difference between the two groups regarding the proportion of NP cultures at Day 12-14 that yield a nonsusceptible S pn isolate.||||0.72
72514666|NCT01511107|144560399|SUPERIORITY_OR_OTHER|||||||0.05|||||||Generalized estimating equations|The p-value is adjusted for S pn susceptibility at onset of the AOM recurrence.||||||0.05
72514667|NCT01511107|144560400|SUPERIORITY_OR_OTHER|||||||0.47|||||||Regression, Logistic|The p-value is adjusted for H flu susceptibility at onset of the index episode.||Null hypothesis: There is no difference between the two groups regarding the proportion of NP cultures at Day 12-14 that yield a nonsusceptible H flu isolate.||||0.47
72514668|NCT01511107|144560401|SUPERIORITY_OR_OTHER|||||||0.69|||||||Generalized estimating equations|The p-value is adjusted for H flu susceptibility at onset of the AOM recurrence.||||||0.69
72514669|NCT01511107|144560402|SUPERIORITY_OR_OTHER|||||||0.16|||||||Regression, Logistic|The p-value is adjusted for site \& the stratification variables, namely age group \& exposure or nonexposure to ≥3 children for ≥10 hours per week.||Null hypothesis: There is no difference between the two groups in the proportion of children followed greater than 60 days having at least one AOM relapse or recurrence within 60 days of enrollment.||||0.16
72514670|NCT01511107|144560403|SUPERIORITY_OR_OTHER|||||||0.32|||||||Regression, Logistic|The p-value is adjusted for site \& the stratification variables, namely age group \& exposure or nonexposure to ≥3 children for ≥10 hours per week.||Null hypothesis: There is no difference between the two groups in the proportion of children completing the study having at least one AOM relapse or recurrence within the entire respiratory season.||||0.32
72514671|NCT01511107|144560404|SUPERIORITY_OR_OTHER|||||||0.23|||||||Regression, Poisson|The p-value is adjusted for site \& the stratification variables, namely age group \& exposure or nonexposure to ≥3 children for ≥10 hours per week.||Null hypothesis: There is no difference between the two groups in the rate of recurrences/relapses within 60 days of enrollment.||||0.23
72514672|NCT01511107|144560405|SUPERIORITY_OR_OTHER|||||||0.22|||||||Regression, Poisson|The p-value is adjusted for site \& the stratification variables, namely age group \& exposure or nonexposure to ≥3 children for ≥10 hours per week.||Null hypothesis: There is no difference between the two groups in the rate of recurrences/relapses within the entire respiratory season.||||0.22
72514673|NCT01511107|144560406|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Regression, Linear|The p-value is adjusted for site \& the stratification variables and for length of follow-up.||Null hypothesis: There is no difference between the two groups in the mean number of days a systemic antibiotic was received during the respiratory season.||||<.001
72514674|NCT01511107|144560407|SUPERIORITY_OR_OTHER|||||||0.07|||||||Generalized estimating equations|The p-value is adjusted for site \& the stratification variables, episode, day of the diary and AOM-SOS score at the episode.||Null hypothesis: There is no difference between the two groups regarding the symptom burden as measured by the respective mean scores over time.||||0.07
72514675|NCT01511107|144560408|SUPERIORITY_OR_OTHER|||||||0.7|||||||Regression, Logistic|The p-value is adjusted for site \& the stratification variables, namely age group \& exposure or nonexposure to ≥3 children for ≥10 hours per week.||Null hypothesis: There is no difference between the two groups in the proportion of children for whom PDD was reported.||||0.70
72514676|NCT01511107|144560409|SUPERIORITY_OR_OTHER|||||||0.86|||||||Regression, Logistic|The p-value is adjusted for site \& the stratification variables, namely age group \& exposure or nonexposure to ≥3 children for ≥10 hours per week.||Null hypothesis: There is no difference between the two groups in the proportion of children for whom diaper dermatitis was reported.||||0.86
72514677|NCT02928380|144560444|OTHER||Least square (LS) mean difference|-0.02||||0.0987|TWO_SIDED|95.0|-0.05|0.0|||ANOVA|ANOVA Model with weight of the peanut particle (food occlusion) as response variable, treatment and period as fixed effect.|Difference is first named treatment minus second named treatment is such that a negative difference favors the first named treatment.|H0: The mean mass of food particles retrieved from using a marketed denture adhesive with a flat ribbon nozzle is no different from using no adhesive H01: The mean mass of food particles retrieved from using a marketed denture adhesive with a flat ribbon nozzle is different from using no adhesive.||0.00|-0.05|0.0987
72514678|NCT03115112|144560535|NON_INFERIORITY|The non-inferiority margin of 0.35% was determined based on a reference clinical trial that demonstrated the effectiveness of sitagliptin, 100 mg, compared to placebo on HbA1c reduction in subjects with type 2 DM. A margin of 0.35% was selected to be approximately half of sitagliptin effect and remained clinically meaningful.|Difference of LS Means|0.08|||||TWO_SIDED|95.0|-0.07|0.22|||||Mixed-effects repeated measures analysis includes region, treatment, visit, treatment-by-visit interaction and the baseline HbA1c value as fixed effect covariates.|||0.22|-0.07|
72514679|NCT03115112|144560536|SUPERIORITY||Difference of LS Means|-0.37||||0.0123|TWO_SIDED|95.0|-0.7|-0.05|||Mixed-effects repeated measures|Covariate includes region, treatment, visit, treatment-by-visit interaction and the baseline FPG value as a fixed effect covariate.||||-0.05|-0.70|0.0123
72514680|NCT03115112|144560537|SUPERIORITY||Difference of LS Means|-2.54|||<|0.0001|TWO_SIDED|95.0|-3.15|-1.92|||Mixed-effects repeated measures|Included region, treatment, visit, treatment-by-visit interaction and the baseline body weight value as fixed effect covariate.||||-1.92|-3.15|<0.0001
72403353|NCT03441633|144312232|SUPERIORITY||Mean Difference (Final Values)|-2.25||||0|TWO_SIDED|95.0|-4.32|-0.18|||ANOVA|||Acenocumarol vs. Apixaban in non-naive participants (NDDDs)||-0.18|-4.32|0.000
72403354|NCT03441633|144312232|SUPERIORITY||Mean Difference (Final Values)|28.52||||0|TWO_SIDED|95.0|27.56|29.48|||ANOVA|||Warfarin vs. Apixaban in naive participants (NDDDs)||29.48|27.56|0.000
72487779|NCT01131676|144504128|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.89||||0.0795|TWO_SIDED|95.02|0.78|1.01||Two-sided test with alpha=0.0498|Cox proportional hazards model|Cox proportional hazards model with factors for treatment, age, gender, categorised BMI, HbA1c, eGFR and geographical region.|All Empagliflozin divided by Placebo|A 4-step hierarchical testing strategy was followed for the non-inferiority test of the primary endpoint and then the key secondary endpoint, each at a margin of 1.3, followed by test of superiority of primary and key secondary endpoints.||1.01|0.78|0.0795
72487780|NCT01131676|144504129|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.28||||0.4172|TWO_SIDED|95.0|0.7|2.33||Two-sided test with alpha = 0.05.|Cox proportional hazards model|Cox proportional hazards model with factors for treatment, age, gender, categorised BMI, HbA1c, eGFR and geographical region.|All Empagliflozin divided by Placebo|||2.33|0.70|0.4172
72487781|NCT01131676|144504130|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.65||||0.0017|TWO_SIDED|95.0|0.5|0.85||Two-sided test with alpha = 0.05.|Cox proportional hazards model|Cox proportional hazards model with factors for treatment, age, gender, categorised BMI, HbA1c, eGFR and geographical region.|All Empagliflozin divided by Placebo|||0.85|0.50|0.0017
72487782|NCT01131676|144504131|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.95||||0.2547|TWO_SIDED|95.0|0.87|1.04||Two-sided test with alpha = 0.05.|Cox proportional hazards model|Cox proportional hazards model with factors for treatment, age, gender, categorised BMI, HbA1c, eGFR and geographical region.|All Empagliflozin divided by Placebo|||1.04|0.87|0.2547
72487783|NCT01131676|144504132|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.62|||<|0.0001|TWO_SIDED|95.0|0.54|0.72||Two-sided test with alpha = 0.05.|Cox proportional hazards model|Cox proportional hazards model with factors for treatment, age, gender, categorised BMI, HbA1c, eGFR and geographical region.|All Empagliflozin divided by Placebo|||0.72|0.54|<0.0001
72487784|NCT01131676|144504133|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.62|||<|0.0001|TWO_SIDED|95.0|0.54|0.7||Two-sided test with alpha = 0.05.|Cox proportional hazards model|Cox proportional hazards model with factors for treatment, age, gender, categorised BMI, HbA1c, eGFR and geographical region.|All Empagliflozin divided by Placebo|||0.70|0.54|<0.0001
72487785|NCT00896779|144504135|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED||||||t-test, 2 sided|||||||0.02
72487786|NCT00896779|144504135|SUPERIORITY_OR_OTHER|||||||0.06|TWO_SIDED||||||t-test, 2 sided|||||||0.06
72487787|NCT00829179|144504141|SUPERIORITY_OR_OTHER||Difference in Mean|11.0|STANDARD_DEVIATION|13.3||0.005||95.0|||||Sign test|||||||0.005
72487788|NCT00941668|144504189|SUPERIORITY_OR_OTHER|||||||0.05|TWO_SIDED|95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
72514681|NCT03115112|144560538|SUPERIORITY||mixed-effects repeated measures|-2.33||||0.0276|TWO_SIDED|95.0|-4.7|0.05|||t-test, 1 sided|p value was presented based on one sided statistical tests using a 0.025 level of significance|Included region, treatment, visit, treatment-by-visit interaction and the baseline body weight value as fixed effect covariate.|||0.05|-4.70|0.0276
72403355|NCT03441633|144312232|SUPERIORITY||Mean Difference (Final Values)|1.93||||0|TWO_SIDED|95.0|-1.05|4.9|||ANOVA|||Warfarin vs. Apixaban in non-naive participants (NDDDs)||4.90|-1.05|0.000
72487789|NCT00941668|144504190|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
72487790|NCT00916149|144504209|OTHER||||||>|0.05||||||For each group (levetiracetam and no treatment), the change in IEDs/hour from pre to post-intervention: p \>0.05. The a priori threshold for statistical significance was p=0.05.|Wilcoxon Signed Ranks Test|||Change in frequency of IEDs/per hour was assessed for each group (levetiracetam and no treatment)||||>0.05
72487791|NCT00916149|144504210|OTHER|||||||0.005|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the CVLT Trial 1 Learning Score from pre to post time points in the no treatment group.||||0.005
72487792|NCT00916149|144504210|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the CVLT Trial 1 Learning Score from pre to post time points in the levetiracetam group.||||>0.05
72487793|NCT00916149|144504211|OTHER|||||||0.016|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the CVLT Total Learning Score from pre to post time points in the no treatment group.||||0.016
72487794|NCT00916149|144504211|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the CVLT Total Learning Score from pre to post time points in the levetiracetam treatment group.||||>0.05
72487795|NCT00916149|144504212|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the CVLT Short Delay score from pre to post time points in the no treatment group.||||>0.05
72487796|NCT00916149|144504212|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the CVLT Short Delay score from pre to post time points in the levetiracetam treatment group.||||>0.05
72487797|NCT00916149|144504213|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the CVLT Long Delay score from pre to post time points in the no treatment group.||||>0.05
72487798|NCT00916149|144504213|OTHER|||||||0.045|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the CVLT Long Delay score from pre to post time points in the levetiracetam treatment group.||||0.045
72487799|NCT00916149|144504214|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the BVMT-R Learning score from pre to post time points in the no treatment group.||||>0.05
72487800|NCT00916149|144504214|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the BVMT-R Learning score from pre to post time points in the levetiracetam treatment group.||||>0.05
72487801|NCT00916149|144504215|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the BVMT-R Total Learning score from pre to post time points in the no treatment group||||>0.05
72403356|NCT00176592|144312259|SUPERIORITY|This includes p value for rank sum test treatment comparison. This includes p value for rank sum test treatment comparison of intention to treat study population.|Mean Difference (Final Values)|0.05|||<|0.05|TWO_SIDED||||||Fisher Exact|||This includes p value for rank sum test treatment comparison. This includes p value for rank sum test treatment comparison of intention to treat study population.||||<0.05
72403357|NCT03089606|144312338|OTHER|2-tailed Fisher's exact test||||||0.08|||||||2-tailed Fisher's exact test|||Null hypothesis. No association between baseline C11-AMT PET SUVmax value and antitumor response to pembrolizumab.||||0.08
72514682|NCT01546285|144560539|NON_INFERIORITY_OR_EQUIVALENCE|This study is to show a mean difference of less than 5mmHg and a standard deviation less than 8mmHg for the difference in systolic, diastolic, and mean BP readings taken by B40 and PRO1000 patient monitors.|Mean Difference (Final Values)|-1.4|STANDARD_DEVIATION|4.8|||TWO_SIDED|95.0|-2.58|-0.22|||Compare the mean difference with 5mmHg|||A total of no less than 65 subjects are needed for this study. Assuming a mean of no more than 4 mmHg and a standard deviation of no more than 5 mmHg for the difference, this sample size ensures that the percent of subjects with equivalent NIBP is at least 80% with 90% confidence. The difference between the B40 and PRO1000 patient monitors in systolic, diastolic, and mean BP determinations will be compared. A difference of within 10 mmHg is considered equivalent in NIBP.||-0.22|-2.58|
72514683|NCT01546285|144560539|NON_INFERIORITY_OR_EQUIVALENCE|This study is to show a mean difference of less than 5mmHg and a standard deviation less than 8mmHg for the difference in systolic, diastolic, and mean BP readings taken by B40 and PRO1000 patient monitors.|Mean Difference (Final Values)|-3.3|STANDARD_DEVIATION|2.6|||TWO_SIDED|95.0|-3.95|-2.66||||||A total of no less than 65 subjects are needed for this study. Assuming a mean of no more than 4mmHg and a standard deviation of no more than 5mmHg for the difference, this sample size ensures that the percent of subjects with equivalent NIBP is a least 80% with 90% confidence. The difference between the B40 and PRO1000 patient monitors in the systolic, diastolic, and mean BP determinations will be compared. A difference of within 10mmHg is considered equivalent in NIBP.||-2.66|-3.95|
72514684|NCT01546285|144560539|NON_INFERIORITY_OR_EQUIVALENCE|This study is to show a mean difference of less than 5mmHg and a standard deviation less than 8mmHg for the difference in systolic, diastolic, and mean BP readings taken by B40 and PRO1000 patient monitors.|Mean Difference (Final Values)|-3.7|STANDARD_DEVIATION|4.2|||TWO_SIDED|95.0|-4.73|-2.67||||||A total of no less than 65 subjects are needed for this study. Assuming a mean of no more than 4mmHg and a standard deviation of no more than 5mmHg for the difference, this sample size ensures that the percent of subjects with equivalent NIBP is a least 80% with 90% confidence. The difference between the B40 and PRO1000 patient monitors in the systolic, diastolic, and mean BP determinations will be compared. A difference of within 10mmHg is considered equivalent in NIBP.||-2.67|-4.73|
72514685|NCT01114373|144560548|SUPERIORITY_OR_OTHER|||||||0.0269|TWO_SIDED||||||ANOVA|||The null hypothesis was that there is no interaction between the order of randomization and the primary outcome measures.||||0.0269
72514686|NCT01114373|144560548|SUPERIORITY_OR_OTHER|||||||0.84|TWO_SIDED||||||ANOVA|||||||0.84
72514687|NCT01114373|144560549|SUPERIORITY_OR_OTHER|||||||0.0492|TWO_SIDED||||||ANOVA|||The null hypothesis was that there is no interaction between the order of randomization and the primary outcome measures.||||0.0492
72514688|NCT01114373|144560549|SUPERIORITY_OR_OTHER|||||||0.95|TWO_SIDED||||||ANOVA|||||||0.95
72514689|NCT01114373|144560550|SUPERIORITY_OR_OTHER|||||||0.91|TWO_SIDED||||||ANOVA|||||||0.91
72514690|NCT01114373|144560551|SUPERIORITY_OR_OTHER|||||||0.88|TWO_SIDED||||||ANOVA|||||||0.88
72514691|NCT01114373|144560552|SUPERIORITY_OR_OTHER|||||||0.16|TWO_SIDED||||||ANOVA|||||||0.16
72514692|NCT01114373|144560553|SUPERIORITY_OR_OTHER|||||||0.12|TWO_SIDED||||||ANOVA|||||||0.12
72514693|NCT01114373|144560554|SUPERIORITY_OR_OTHER|||||||0.12|TWO_SIDED||||||ANOVA|||||||0.12
72514694|NCT01114373|144560555|SUPERIORITY_OR_OTHER|||||||0.21|TWO_SIDED||||||ANOVA|||||||0.21
72514695|NCT01114373|144560556|SUPERIORITY_OR_OTHER|||||||0.06|TWO_SIDED||||||Friedman|||||||0.06
72514696|NCT01114373|144560557|SUPERIORITY_OR_OTHER|||||||0.21|TWO_SIDED||||||Friedman|||||||0.21
72514697|NCT01114373|144560558|SUPERIORITY_OR_OTHER|||||||0.41|TWO_SIDED||||||Friedman|||||||0.41
72514698|NCT01114373|144560559|SUPERIORITY_OR_OTHER|||||||0.13|TWO_SIDED||||||ANOVA|||||||0.13
72514699|NCT01114373|144560560|SUPERIORITY_OR_OTHER|||||||0.58|TWO_SIDED||||||ANOVA|||||||0.58
72514700|NCT01114373|144560561|SUPERIORITY_OR_OTHER|||||||0.39|TWO_SIDED||||||ANOVA|||||||0.39
72514701|NCT00421603|144560636|NON_INFERIORITY_OR_EQUIVALENCE|All analyses were conducted on the intent-to-treat sample of all randomized patients. All statistical tests were 2-tailed and employed at a significance level of 5%, unless otherwise stated. The original sample size of 120 patients was chosen to ensure sufficient power (at least 80%) of a two-sided test with level of significance α=0.05 for detecting difference between the two experimental treatments with respect to the percentage of subjects who achieve continuous 3-weeks abstinence.|||||=|0.05|||||||Chi-squared, Corrected|||The dichotomous primary outcome was analyzed using logistic regression with independent predictors: treatment (MAS-ER and topiramate vs. placebo) and adjusted for baseline severity of cocaine use (total number of cocaine use days in the 28 days prior to randomization).||||=.05
72514702|NCT03444870|144560644|SUPERIORITY||Difference in adjusted mean|-0.31|STANDARD_ERROR_OF_MEAN|0.18||0.0954|TWO_SIDED|95.0|-0.66|0.05|||ANCOVA|||Change from Baseline was calculated based on ANCOVA analysis model which included the following covariates and stratification factors =Treatment + Baseline (BL) + Geographic Region + Disease Stage + AD Medication at BL + Apolipoprotein E, Allele e4 (APOE e4) + Baseline Alzheimer Disease Assessment Scale-Cognition Subscale 13 (ADAS-Cog13) Score + Baseline Alzheimer Disease Cooperative Study Group-Activities of Daily Living (ADCS-ADL).||0.05|-0.66|0.0954
72514703|NCT03444870|144560646|SUPERIORITY||Difference in adjusted mean|-1.25|STANDARD_ERROR_OF_MEAN|0.65||0.0544|TWO_SIDED|95.0|-2.52|0.02|||ANCOVA|||Change from BL was calculated based on ANCOVA analysis model which included the following covariates and stratification factors = Treatment + Baseline + Geographical Region + Disease Stage + AD Medication at BL + APOE e4.||0.02|-2.52|0.0544
72514704|NCT03444870|144560647|SUPERIORITY||Difference in adjusted mean|1.11|STANDARD_ERROR_OF_MEAN|0.81||0.1729|TWO_SIDED|95.0|-0.48|2.7|||ANCOVA|||Change from BL was calculated based on ANCOVA analysis model which included the following covariates and stratification factors = Treatment + Baseline + Region + Disease Stage + AD Medication at BL + APOE e4.||2.70|-0.48|0.1729
72403358|NCT00566150|144312365|SUPERIORITY_OR_OTHER_LEGACY|||||||0.29|TWO_SIDED|95.0||||Unadjusted. Statistical significance was p\<0.05.|Mixed Models Analysis|Fixed categorical effects: group (as a between-subjects factor), time (as a within-subjects factor), group x time interaction.||Comparison of changes in outcome between treatment groups at week 6.||||0.29
72487802|NCT00916149|144504215|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the BVMT-R Total Learning score from pre to post time points in the levetiracetam treatment group||||>0.05
72487803|NCT00916149|144504216|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the BVMT-R Delayed Recall score from pre to post time points in the no treatment group||||>0.05
72487804|NCT00916149|144504216|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the BVMT-R Delayed Recall score from pre to post time points in the levetiracetam treatment group||||>0.05
72487805|NCT00916149|144504217|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the QOLIE score from pre to post time points in the levetiracetam treatment group||||>0.05
72514705|NCT03444870|144560648|SUPERIORITY||Difference in adjusted mean|-0.86|STANDARD_ERROR_OF_MEAN|0.42||0.0425|TWO_SIDED|95.0|-1.68|-0.03|||ANCOVA|||Change from BL was calculated based on ANCOVA analysis model which included the following covariates and stratification factors = Treatment + Baseline + Geographical Region + Disease Stage + AD Medication at BL + APOE e4.||-0.03|-1.68|0.0425
72514706|NCT03444870|144560649|SUPERIORITY||Difference in adjusted mean|0.32|STANDARD_ERROR_OF_MEAN|0.31||0.2904|TWO_SIDED|95.0|-0.28|0.93|||ANCOVA|||Change from Baseline was calculated based on ANCOVA analysis model which included the following covariates and stratification factors =Treatment + Baseline + Geographic Region + Disease Stage + AD Medication at BL + APOE e4.||0.93|-0.28|0.2904
72514707|NCT03444870|144560650|SUPERIORITY||Difference in adjusted mean|-0.97|STANDARD_ERROR_OF_MEAN|0.6||0.1036|TWO_SIDED|95.0|-2.14|0.2|||ANCOVA|||Change from BL was calculated based on ANCOVA analysis model which included the following covariates and stratification factors = Treatment + Baseline + Geographical Region + Disease Stage + AD Medication at BL + APOE e4.||0.20|-2.14|0.1036
72514708|NCT03444870|144560651|SUPERIORITY||Difference in adjusted mean|-0.07|STANDARD_ERROR_OF_MEAN|0.37||0.8468|TWO_SIDED|95.0|-0.79|0.65|||ANCOVA|||Change from BL was calculated based on ANCOVA analysis model which included the following covariates and stratification factors = Treatment + Baseline + Geographical Region + Disease Stage + AD Medication at BL + APOE e4.||0.65|-0.79|0.8468
72514709|NCT03444870|144560652|SUPERIORITY||Difference in adjusted mean|0.2|STANDARD_ERROR_OF_MEAN|0.79||0.803|TWO_SIDED|95.0|-1.35|1.74|||ANCOVA|||Change from BL was calculated based on ANCOVA analysis model which included the following covariates and stratification factors = Treatment + Baseline + Geographical Region + Disease Stage + AD Medication at BL + APOE e4.||1.74|-1.35|0.8030
72514710|NCT03444870|144560653|SUPERIORITY||Difference in adjusted mean|1.0|STANDARD_ERROR_OF_MEAN|0.68||0.1439|TWO_SIDED|95.0|-0.34|2.34|||ANCOVA|||Change from BL was calculated based on ANCOVA analysis model which included the following covariates and stratification factors = Treatment + Baseline + Geographical Region + Disease Stage + AD Medication at BL + APOE e4.||2.34|-0.34|0.1439
72514711|NCT03444870|144560660|SUPERIORITY||Difference in adjusted means|-66.44|STANDARD_ERROR_OF_MEAN|4.171|<|0.0001|TWO_SIDED|95.0|-74.71|-58.16|||Mixed Model for Repeated Measures|||Change from BL was calculated based on mixed-effect model of repeated measure which included the following covariates and stratification factors = Baseline + APOE e4 status + Type of Tracer + Analysis Visit + Treatment + Treatment\*Analysis Visit + Analysis Visit\*Baseline.||-58.16|-74.71|<.0001
72514712|NCT03444870|144560661|SUPERIORITY||Difference in adjusted mean|0.01|STANDARD_ERROR_OF_MEAN|0.023||0.7816|TWO_SIDED|95.0|-0.04|0.05|||Mixed Model for Repeated Measures|||Temporal Composite Region: Change from BL was calculated based on mixed-effect model of repeated measure which included the following covariates and stratification factors = Baseline + APOE e4 status + Study + Analysis Visit + Treatment + Treatment\*Analysis Visit + Analysis Visit\*Baseline.||0.05|-0.04|0.7816
72403359|NCT00566150|144312366|SUPERIORITY_OR_OTHER_LEGACY|||||||0.07|TWO_SIDED|95.0||||Unadjusted. Statistical significance was p\<0.05.|Mixed Models Analysis|Fixed categorical effects: group (as a between-subjects factor), time (as a within-subjects factor), group x time interaction.||Comparison of changes in outcome between treatment groups at week 6.||||0.07
72487806|NCT00916149|144504218|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the Letter Number Sequencing score from pre to post time points in the no treatment group||||>0.05
72487807|NCT00916149|144504218|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the Letter Number Sequencing score from pre to post time points in the levetiracetam treatment group||||>0.05
72487808|NCT00916149|144504219|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the Spatial Span score from pre to post time points in the no treatment group||||>0.05
72487809|NCT00916149|144504219|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the Spatial Span score from pre to post time points in the levetiracetam treatment group||||>0.05
72487810|NCT00916149|144504220|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the Digit Span score from pre to post time points in the no treatment group||||>0.05
72487811|NCT00916149|144504220|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the Digit Span score from pre to post time points in the levetiracetam treatment group||||>0.05
72487812|NCT00916149|144504221|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the Verbal Fluency score from pre to post time points in the no treatment group||||>0.05
72487813|NCT00916149|144504221|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the Verbal Fluency score from pre to post time points in the levetiracetam treatment group||||>0.05
72487814|NCT00916149|144504222|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in Stroop performance from pre to post time points in the no treatment group||||>0.05
72487815|NCT00916149|144504222|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in Stroop performance from pre to post time points in the levetiracetam treatment group||||>0.05
72487816|NCT00916149|144504223|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the Design Fluency score from pre to post time points in the no treatment group||||>0.05
72403360|NCT00566150|144312367|SUPERIORITY_OR_OTHER_LEGACY|||||||0.038||95.0||||Statistical significance was p\<0.05|Fisher Exact|Fisher's exact test was used to test for significance between groups.||Week 6||||.038
72403361|NCT00566150|144312368|SUPERIORITY_OR_OTHER_LEGACY|||||||0.79||95.0||||Unadjusted. Statistical significance was p\<0.05.|Mixed Models Analysis|Fixed categorical effects: group (as a between-subjects factor), time (as a within-subjects factor), group x time interaction.||Comparison of changes in outcome between treatment groups.||||0.79
72403362|NCT01527682|144312370|OTHER||Proportion|76.7|||||TWO_SIDED|95.0|64.1|89.4|||||||The statistical analysis was performed according to study design. Using a Fleming single stage design (A'Hern approach) setting the probability of erroneously concluding that the responders rate is greater than 35% at 5% (one-sided alpha=0.05) and the probability of correctly concluding that the responders rate is at least 50% at 80% (beta error = 0.20), the minimum number of responder eyes was set at 31 out of 68, since this result is associated with a lower limit of the 90% exact confidence interval of 35.2%.|89.4|64.1|
72403363|NCT04365556|144312403|SUPERIORITY||||||<|0.001||||||a priori threshold for statistical significance is p\<.05|ANCOVA|||||||<0.001
72403364|NCT04365556|144312404|SUPERIORITY|||||||0.69|||||||ANCOVA|||||||0.69
72403365|NCT01023581|144312411|SUPERIORITY_OR_OTHER||LS mean difference|-0.67|||<|0.001|TWO_SIDED|95.0|-0.96|-0.37||For each set of comparisons in the primary analysis, the null hypothesis was rejected only if both comparisons between a combination and its constituent doses were statistically significant at the 2-sided 2.5% level.|ANCOVA|ANCOVA model with treatment and geographic region as fixed effects and baseline HbA1c as a covariate.||The primary efficacy analysis consisted of 2 separate sets of comparisons between each BID combination of alogliptin and metformin (alogliptin/metformin 12.5/500 mg BID and 12.5/1000 mg BID) and its constituent doses of alogliptin and metformin. The null hypothesis was that the combination of alogliptin and metformin had no additional effect on glycemic control at Week 26 either when compared with the constituent dose of alogliptin or with the constituent dose of metformin.||-0.37|-0.96|<0.001
72403366|NCT01023581|144312411|SUPERIORITY_OR_OTHER||LS mean difference|-0.57|||<|0.001|TWO_SIDED|95.0|-0.87|-0.27|||ANCOVA|ANCOVA model with treatment and geographic region as fixed effects and baseline HbA1c as a covariate||||-0.27|-0.87|<0.001
72403367|NCT01023581|144312411|SUPERIORITY_OR_OTHER||LS mean difference|-1.0|||<|0.001|TWO_SIDED|95.0|-1.29|-0.71|||ANCOVA|ANCOVA model with treatment and geographic region as fixed effects and baseline HbA1c as a covariate.||||-0.71|-1.29|<0.001
72403368|NCT01023581|144312411|SUPERIORITY_OR_OTHER||LS mean difference|-0.44|||<|0.001|TWO_SIDED|95.0|-0.73|-0.16|||ANCOVA|ANCOVA model with treatment and geographic region as fixed effects and baseline HbA1c as a covariate.||||-0.16|-0.73|<0.001
72403369|NCT04920123|144312427|SUPERIORITY|||||||0.997||||||The threshold for statistical significance was p=0.05|t-test, 1 sided|||Null hypothesis: no improvement or worse with intervention Alternative hypothesis: improvement with intervention||||0.997
72403370|NCT04920123|144312428|SUPERIORITY|||||||0.5||||||The threshold for statistical significance was p=0.05|t-test, 1 sided|||Null hypothesis: no improvement or worse with intervention Alternative hypothesis: improvement with intervention||||0.500
72403371|NCT04920123|144312429|SUPERIORITY|||||||0.821||||||The threshold for statistical significance was p=0.05|t-test, 1 sided|||Null hypothesis: no improvement or worse with intervention Alternative hypothesis: improvement with intervention||||0.821
72403372|NCT04920123|144312430|SUPERIORITY|||||||0.995||||||The threshold for statistical significance was p=0.05|t-test, 1 sided|||Null hypothesis: no improvement or worse with intervention Alternative hypothesis: improvement with intervention||||0.995
72403373|NCT04920123|144312431|NON_INFERIORITY|Higher scores indicate more severe depression.||||||0.076|||||||t-test, 1 sided|||Null hypothesis: no improvement or worse with intervention Alternative hypothesis: improvement with intervention||||0.076
72403374|NCT04920123|144312432|SUPERIORITY|||||||0.432|||||||t-test, 1 sided|The threshold for statistical significance was p=0.05||Null hypothesis: no improvement or worse with intervention Alternative hypothesis: improvement with intervention||||0.432
72403375|NCT04920123|144312433|SUPERIORITY|Null hypothesis: no improvement or worse with intervention Alternative hypothesis: improvement with intervention||||||0.75|||||||t-test, 1 sided|||||||0.750
72403376|NCT00278954|144312434|SUPERIORITY_OR_OTHER||SABI per subject per year|0.0||||0.01||99.0|0.0|0.101|||Poisson regression with log link||Mean SABI rate = 0 per subject per year. 1-sided 99% upper confidence bound could not be calculated.|The estimated serious acute bacterial infection (SABI) rate was calculated by dividing no. of infections by no.of subject years. The exponential of the upper limit of the 98% 2-sided Confidence Interval (CI) gave the upper, 1-sided, 99% confidence bound, estimated using Poisson regression. The equivalent upper bound per subject year was obtained by dividing this figure by total subject years.||0.101|0|0.01
72403377|NCT05664490|144312481|SUPERIORITY||Risk Ratio (RR)|0.88||||0.44|TWO_SIDED|95.0|0.64|1.22||The threshold for statistical significance is 0.05.|Poisson regression|We used Poisson regression with a log-link and robust standard errors to assess the effect of our intervention on PrEP adherence at Week 12|The Standard of Care Mental Health Services arm was the reference category for the risk ratio.|||1.22|0.64|0.44
72403378|NCT05664490|144312482|SUPERIORITY||Risk Ratio (RR)|1.0||||0.99|TWO_SIDED|95.0|0.71|1.42||The threshold for statistical significance was 0.05.|Poisson regression|We used Poisson regression with a log-link and robust standard errors to assess the effect of our intervention on reduced CMD symptoms at Week 12.|The reference category for the risk ratio presented is the Standard of Care Mental Health Services arm.|||1.42|0.71|0.99
72403379|NCT05664490|144312483|SUPERIORITY||Risk Ratio (RR)|1.4||||0.03|TWO_SIDED|95.0|1.03|1.89||The threshold for statistical significance was 0.05|Poisson regression|We used Poisson regression with a log-link to estimate to assess the effect of our intervention on PrEP adherence at Week 4.|The Standard of Care Mental Health Services arm was the reference category for the risk ratio.|||1.89|1.03|0.03
72403380|NCT05664490|144312484|SUPERIORITY||Risk Ratio (RR)|0.81||||0.37|TWO_SIDED|95.0|0.5|1.29||The threshold for statistical significance was 0.05|Poisson regression|We used Poisson regression with a log-link to assess the effect of the intervention on common mental disorders at Week 4.|The Standard of Care Mental Health Services arm was the reference category.|||1.29|0.50|0.37
72403381|NCT04064294|144312497|SUPERIORITY|||||||0.63||||||the threshold for statistical significance was p = 0.05|ANOVA|degrees of freedom = 78||||||0.63
72403382|NCT04064294|144312498|SUPERIORITY|||||||0.09||||||the threshold for statistical significance was p = 0.05|ANOVA|degrees of freedom = 78||||||0.09
72403383|NCT04064294|144312499|SUPERIORITY|||||||0.011|||||||Chi-squared|threshold for significance is 0.05, degrees of freedom = 2||||||0.011
72403384|NCT04064294|144312500|SUPERIORITY|||||||0.033|||||||ANOVA|degrees of freedom = 75||||||0.033
72487817|NCT00916149|144504223|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the Design Fluency score from pre to post time points in the levetiracetam treatment group||||>0.05
72487818|NCT00916149|144504224|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in performance on the Trails Test from pre to post time points in the no treatment group||||>0.05
72487819|NCT00916149|144504224|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in performance on the Trails Test from pre to post time points in the levetiracetam treatment group||||>0.05
72487820|NCT00916149|144504225|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in performance on the Grooved Pegboard task from pre to post time points in the no treatment group||||>0.05
72514713|NCT03444870|144560661|SUPERIORITY||Difference in adjusted means|0.01|STANDARD_ERROR_OF_MEAN|0.018||0.6203|TWO_SIDED|95.0|-0.03|0.05|||Mixed Model for Repeated Measures|||Medial Temporal Composite Region: Change from BL was calculated based on mixed-effect model of repeated measure which included the following covariates and stratification factors = Baseline + APOE e4 status + Study + Analysis Visit + Treatment + Treatment\*Analysis Visit + Analysis Visit\*Baseline.||0.05|-0.03|0.6203
72514714|NCT03444870|144560661|SUPERIORITY||Difference in adjusted means|0.0|STANDARD_ERROR_OF_MEAN|0.015||0.7754|TWO_SIDED|95.0|-0.03|0.03|||Mixed Model for Repeated Measures|||Frontal Lobe: Change from BL was calculated based on mixed-effect model of repeated measure which included the following covariates and stratification factors = Baseline + APOE e4 status + Study + Analysis Visit + Treatment + Treatment\*Analysis Visit + Analysis Visit\*Baseline.||0.03|-0.03|0.7754
72514715|NCT03444870|144560661|SUPERIORITY||Difference in adjusted means|0.0|STANDARD_ERROR_OF_MEAN|0.026||0.9022|TWO_SIDED|95.0|-0.05|0.05|||Mixed Model for Repeated Measures|||Parietal Lobe: Change from BL was calculated based on mixed-effect model of repeated measure which included the following covariates and stratification factors = Baseline + APOE e4 status + Study + Analysis Visit + Treatment + Treatment\*Analysis Visit + Analysis Visit\*Baseline.||0.05|-0.05|0.9022
72514716|NCT03444870|144560662|SUPERIORITY||||||<|0.001|||||||ANCOVA|||Parietal Lobe: Change from BL was calculated based on mixed-effect model of repeated measure which included the following covariates and stratification factors = Baseline + APOE e4 status + Study + Analysis Visit + Treatment + Treatment\*Analysis Visit + Analysis Visit\*Baseline.||||<.001
72514717|NCT03444870|144560663|SUPERIORITY||||||<|0.001|||||||ANCOVA|||||||<.001
72514718|NCT03444870|144560664|SUPERIORITY|||||||0.396|||||||ANCOVA|||||||0.396
72403385|NCT03450707|144312501|OTHER||Mean Difference (Final Values)|0.34||||0.72|TWO_SIDED|95.0|-1.82|2.5||"Mixed model controlling for repeated measures within patients used to get a mean difference in lactate between the thiamine and placebo groups at 24 hours.~Lactate imputed using a penalty (20pc increase) for patients who expired."|Mixed Models Analysis|P-value is for the comparison at 24 hours from the mixed model (i.e, not a global p-value)||||2.50|-1.82|0.72
72403386|NCT03450707|144312502|OTHER||Mean Difference (Final Values)|-0.38||||0.43|TWO_SIDED|95.0|-1.34|0.58|||Regression, Linear|||As AUC-VO2s turned out to be normally distributed, we used a linear regression model to compare mean AUC-VO2s between treatment groups controlling for average temperature.||0.58|-1.34|0.43
72403387|NCT03450707|144312503|OTHER|||||||0.88|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon rank-sum test, testing the null hypothesis that there is no difference in the distribution of 72-hour lactates between thiamine and placebo groups.|No parameter estimated other than p-value = 0.88 from Wilcoxon rank-sum test.|||0.88
72487821|NCT00916149|144504225|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in performance on the Grooved Pegboard task from pre to post time points in the levetiracetam treatment group||||>0.05
72487822|NCT00916149|144504226|OTHER|||||||0.014|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the Digit Symbol score from pre to post time points in the no treatment group||||0.014
72487823|NCT00916149|144504226|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the Digit Symbol score from pre to post time points in the levetiracetam treatment group||||>0.05
72487824|NCT00916149|144504227|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the CPT Accuracy score from pre to post time points in the no treatment group||||>0.05
72487825|NCT00916149|144504227|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the CPT Accuracy score from pre to post time points in the levetiracetam treatment group||||>0.05
72487826|NCT00916149|144504228|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the CPT reaction time from pre to post time points in the no treatment group||||>0.05
72487827|NCT00916149|144504228|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the CPT reaction time from pre to post time points in the levetiracetam treatment group||||>0.05
72487828|NCT00916149|144504229|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the Choice Accuracy score from pre to post time points in the no treatment group||||>0.05
72487829|NCT00916149|144504230|OTHER|||||||0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the Choice Reaction Time score from pre to post time points in the no treatment group||||0.05
72487830|NCT00916149|144504231|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the Verbal Working Memory Accuracy score from pre to post time points in the no treatment group||||>0.05
72514719|NCT03444870|144560665|SUPERIORITY||||||<|0.001|||||||ANCOVA|||||||<.001
72514720|NCT01205451|144560689|SUPERIORITY_OR_OTHER||t-distribution|-1.21|||<|0.0001|TWO_SIDED|95.0|-1.38|-1.04||The P-value for change from Baseline indicates the comparision of the Week 6 value against the Baseline value.|Wilcoxon signed-rank test||Confidence intervals for means were based on the t-distribution.|||-1.04|-1.38|<0.0001
72403388|NCT03450707|144312504|OTHER||Mean Difference (Final Values)|0.4||||0.072|TWO_SIDED|95.0|0.01|0.8||Mixed model controlling for repeated measures within patients used to get a mean difference in PDH specific activity between the thiamine and placebo groups at 72 hours.|Mixed Models Analysis|P-value is the global p-value from the mixed model. P-value is obtained from a model that uses a log-transformed version of the variable.||||0.80|0.01|0.072
72568043|NCT02037165|144667474|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.54|STANDARD_ERROR_OF_MEAN|4.1389|||TWO_SIDED|95.0|-7.7|8.8|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 22:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||8.8|-7.7|
72514721|NCT01205451|144560689|SUPERIORITY_OR_OTHER||t-distribution|-1.33|||<|0.0001|TWO_SIDED|95.0|-1.54|-1.12||The P-value for change from Baseline indicates the comparision of the Week 6 value against the Baseline value.|Wilcoxon signed-rank test||Confidence intervals for means were based on the t-distribution.|||-1.12|-1.54|<0.0001
72514722|NCT01205451|144560689|SUPERIORITY_OR_OTHER||t-distribution|-0.88|||<|0.0001|TWO_SIDED|95.0|-1.04|-0.72||The P-value for change from Baseline indicates the comparision of the Week 12 value against the Baseline value.|Wilcoxon signed-rank test||Confidence intervals for means were based on the t-distribution.|||-0.72|-1.04|<0.0001
72514723|NCT01205451|144560689|SUPERIORITY_OR_OTHER||t-distribution|-1.12|||<|0.0001|TWO_SIDED|95.0|-1.33|-0.91||The P-value for change from Baseline indicates the comparision of the Week 12 value against the Baseline value.|Wilcoxon signed-rank test||Confidence intervals for means were based on the t-distribution.|||-0.91|-1.33|<0.0001
72514724|NCT03084718|144560712|SUPERIORITY||Mean Difference (Final Values)|0.044||||0.567|TWO_SIDED|95.0|-0.052|0.14|||Mixed Models Analysis|||"Comparison treatment groups were:~Treatment A (CHF 718 pMDI 100 µg TDD) vs Treatment D (Placebo)"||0.140|-0.052|0.567
72514725|NCT03084718|144560712|SUPERIORITY||Mean Difference (Final Values)|0.113||||0.015|TWO_SIDED|95.0|0.018|0.209|||Mixed Models Analysis|||"Comparison treatment groups were:~Treatment B (CHF 718 pMDI 400 µg TDD) vs Treatment D (Placebo)"||0.209|0.018|0.015
72514726|NCT03084718|144560712|SUPERIORITY||Mean Difference (Final Values)|0.093||||0.059|TWO_SIDED|95.0|-0.003|0.188|||Mixed Models Analysis|||"Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment D (Placebo)"||0.188|-0.003|0.059
72514727|NCT03084718|144560712|SUPERIORITY||Mean Difference (Final Values)|0.069||||0.09|TWO_SIDED|95.0|-0.011|0.15|||Mixed Models Analysis|||"Comparison treatment groups were:~Treatment B (CHF 718 pMDI 400 µg TDD) vs Treatment A (CHF 718 pMDI 100 µg TDD)"||0.150|-0.011|0.090
72514728|NCT03084718|144560712|SUPERIORITY||Mean Difference (Final Values)|0.049||||0.231|TWO_SIDED|95.0|-0.031|0.129|||Mixed Models Analysis|||"Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment A (CHF 718 pMDI 100 µg TDD)"||0.129|-0.031|0.231
72514729|NCT03084718|144560712|SUPERIORITY||Mean Difference (Final Values)|-0.021||||0.612|TWO_SIDED|95.0|-0.101|0.059|||Mixed Models Analysis|||"Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment B (CHF 718 pMDI 400 µg TDD)"||0.059|-0.101|0.612
72514730|NCT03084718|144560712|SUPERIORITY||Mean Difference (Final Values)|0.102||||0.011|TWO_SIDED|95.0|0.023|0.18|||Mixed Models Analysis|||"Comparison treatment groups were:~Treatment E (QVAR\^®, 320 µg TDD) vs Treatment D (Placebo)"||0.180|0.023|0.011
72514731|NCT03084718|144560713|SUPERIORITY||Mean Difference (Final Values)|0.018||||0.647|TWO_SIDED|95.0|-0.06|0.097|||Mixed Models Analysis|||"Comparison treatment groups were:~Treatment A (CHF 718 pMDI 100 µg TDD) vs Treatment D (Placebo)"||0.097|-0.060|0.647
72514732|NCT03084718|144560713|SUPERIORITY||Mean Difference (Final Values)|0.118||||0.004|TWO_SIDED|95.0|0.039|0.196|||Mixed Models Analysis|||"Comparison treatment groups were:~Treatment B (CHF 718 pMDI 400 µg TDD) vs Treatment D (Placebo)"||0.196|0.039|0.004
72514733|NCT03084718|144560713|SUPERIORITY||Mean Difference (Final Values)|0.071||||0.076|TWO_SIDED|95.0|-0.008|0.149|||Mixed Models Analysis|||"Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment D (Placebo)"||0.149|-0.008|0.076
72514734|NCT03084718|144560713|SUPERIORITY||Mean Difference (Final Values)|0.099||||0.014|TWO_SIDED|95.0|0.02|0.179|||Mixed Models Analysis|||"Comparison treatment groups were:~Treatment B (CHF 718 pMDI 400 µg TDD) vs Treatment A (CHF 718 pMDI 100 µg TDD)"||0.179|0.020|0.014
72403389|NCT03450707|144312505|OTHER||Mean Difference (Final Values)|2.4||||0.044|TWO_SIDED|95.0|0.1|4.7||Mixed model controlling for repeated measures within patients used to get a mean difference in PDH activity between the thiamine and placebo groups at 72 hours.|Mixed Models Analysis|P-value is the global p-value from the mixed model. P-value is obtained from a model that uses a log-transformed version of the variable.||||4.7|0.1|0.044
72514735|NCT03084718|144560713|SUPERIORITY||Mean Difference (Final Values)|0.052||||0.192|TWO_SIDED|95.0|-0.026|0.131|||Mixed Models Analysis|||"Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment A (CHF 718 pMDI 100 µg TDD)"||0.131|-0.026|0.192
72514736|NCT03084718|144560713|SUPERIORITY||Mean Difference (Final Values)|-0.047||||0.244|TWO_SIDED|95.0|-0.126|0.032|||Mixed Models Analysis|||"Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment B (CHF 718 pMDI 400 µg TDD)"||0.032|-0.126|0.244
72514737|NCT03084718|144560713|SUPERIORITY||Mean Difference (Final Values)|0.074||||0.06|TWO_SIDED|95.0|-0.003|0.151|||Mixed Models Analysis|||"Comparison treatment groups were:~Treatment E (QVAR\^®, 320 µg TDD) vs Treatment D (Placebo)"||0.151|-0.003|0.060
72514738|NCT03084718|144560714|SUPERIORITY||Mean Difference (Final Values)|0.012||||0.78|TWO_SIDED|95.0|-0.074|0.098|||Mixed Models Analysis|||"Week 4~Comparison treatment groups were:~Treatment A (CHF 718 pMDI 100 µg TDD) vs Treatment D (Placebo)"||0.098|-0.074|0.780
72568044|NCT02037165|144667474|SUPERIORITY_OR_OTHER||Adjusted mean difference|-2.04|STANDARD_ERROR_OF_MEAN|3.3835|||TWO_SIDED|95.0|-8.8|4.7|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 24:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||4.7|-8.8|
72568045|NCT02037165|144667475|SUPERIORITY_OR_OTHER||adjusted mean difference|-29.67|STANDARD_ERROR_OF_MEAN|29.5691|||TWO_SIDED|95.0|-88.3|29.0|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 0:30h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||29.0|-88.3|
72568046|NCT02037165|144667475|SUPERIORITY_OR_OTHER||adjusted mean difference|-16.29|STANDARD_ERROR_OF_MEAN|29.8613|||TWO_SIDED|95.0|-75.5|42.9|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 1:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||42.9|-75.5|
72568047|NCT02037165|144667475|SUPERIORITY_OR_OTHER||adjusted mean difference|7.63|STANDARD_ERROR_OF_MEAN|25.1035|||TWO_SIDED|95.0|-42.2|57.5|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 2:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||57.5|-42.2|
72568048|NCT02037165|144667475|SUPERIORITY_OR_OTHER||adjusted mean difference|-20.47|STANDARD_ERROR_OF_MEAN|23.311|||TWO_SIDED|95.0|-66.7|25.8|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 3:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||25.8|-66.7|
72568049|NCT02037165|144667475|SUPERIORITY_OR_OTHER||adjusted mean difference|-12.63|STANDARD_ERROR_OF_MEAN|23.1894|||TWO_SIDED|95.0|-58.6|33.4|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 4:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||33.4|-58.6|
72577096|NCT00580788|144680813|NON_INFERIORITY_OR_EQUIVALENCE|The study was designed as a standard dose-escalation study, dose-finding pilot study. The primary outcome measures were safety (hypercalcemia, hypophosphatemia and symptoms/hemodynamic measurements). A modified Fibronacci dose-escalation scheme was employed.||||||0.61|TWO_SIDED|||||The reported p-value corresponds to all Arms/Groups at all time points compared to baseline|Mixed Models Analysis|The level of statistical significance was set at .05 (two-tailed)||||||0.61
72403390|NCT03450707|144312506|OTHER||Mean Difference (Final Values)|-48.5||||0.828|TWO_SIDED|95.0|-297.0|200.0||Mixed model controlling for repeated measures within patients used to get a mean difference in PDH quantity between the thiamine and placebo groups at 72 hours.|Mixed Models Analysis|P-value is the global p-value from the mixed model. P-value is obtained from a model that uses a log-transformed version of the variable.||||200.0|-297.0|0.828
72403391|NCT03450707|144312509|OTHER||Mean Difference (Final Values)|2.34||||0.1|TWO_SIDED|95.0|0.47|4.22||Mixed model controlling for repeated measures within patients used to get a mean difference in SOFA scores between the thiamine and placebo groups at 72 hours.|Mixed Models Analysis|P-value is the global p-value from the mixed model.||||4.22|0.47|0.10
72514739|NCT03084718|144560714|SUPERIORITY||Mean Difference (Final Values)|0.076||||0.086|TWO_SIDED|95.0|-0.011|0.162|||Mixed Models Analysis|||"Week 4~Comparison treatment groups were:~Treatment B (CHF 718 pMDI 400 µg TDD) vs Treatment D (Placebo)"||0.162|-0.011|0.086
72514740|NCT03084718|144560714|SUPERIORITY||Mean Difference (Final Values)|0.043||||0.324|TWO_SIDED|95.0|-0.043|0.129|||Mixed Models Analysis|||"Week 4~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment D (Placebo)"||0.129|-0.043|0.324
72514741|NCT03084718|144560714|SUPERIORITY||Mean Difference (Final Values)|0.063||||0.153|TWO_SIDED|95.0|-0.024|0.15|||Mixed Models Analysis|||"Week 4~Comparison treatment groups were:~Treatment B (CHF 718 pMDI 400 µg TDD) vs Treatment A (CHF 718 pMDI 100 µg TDD)"||0.150|-0.024|0.153
72514742|NCT03084718|144560714|SUPERIORITY||Mean Difference (Final Values)|0.031||||0.482|TWO_SIDED|95.0|-0.055|0.117|||Mixed Models Analysis|||"Week 4~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment A (CHF 718 pMDI 100 µg TDD)"||0.117|-0.055|0.482
72514743|NCT03084718|144560714|SUPERIORITY||Mean Difference (Final Values)|-0.032||||0.463|TWO_SIDED|95.0|-0.119|0.054|||Mixed Models Analysis|||"Week 4~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment B (CHF 718 pMDI 400 µg TDD)"||0.054|-0.119|0.463
72514744|NCT03084718|144560714|SUPERIORITY||Mean Difference (Final Values)|0.032||||0.453|TWO_SIDED|95.0|-0.052|0.117|||Mixed Models Analysis|||"Week 4~Comparison treatment groups were:~Treatment E (QVAR\^®, 320 µg TDD) vs Treatment D (Placebo)"||0.117|-0.052|0.453
72514745|NCT03084718|144560714|SUPERIORITY||Mean Difference (Final Values)|0.03||||0.533|TWO_SIDED|95.0|-0.064|0.123|||Mixed Models Analysis|||"Week 8~Comparison treatment groups were:~Treatment A (CHF 718 pMDI 100 µg TDD) vs Treatment D (Placebo)"||0.123|-0.064|0.533
72514746|NCT03084718|144560714|SUPERIORITY||Mean Difference (Final Values)|0.105||||0.029|TWO_SIDED|95.0|0.011|0.199|||Mixed Models Analysis|||"Week 8~Comparison treatment groups were:~Treatment B (CHF 718 pMDI 400 µg TDD) vs Treatment D (Placebo)"||0.199|0.011|0.029
72514747|NCT03084718|144560714|SUPERIORITY||Mean Difference (Final Values)|0.052||||0.274|TWO_SIDED|95.0|-0.041|0.146|||Mixed Models Analysis|||"Week 8~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment D (Placebo)"||0.146|-0.041|0.274
72514748|NCT03084718|144560714|SUPERIORITY||Mean Difference (Final Values)|0.075||||0.119|TWO_SIDED|95.0|-0.019|0.169|||Mixed Models Analysis|||"Week 8~Comparison treatment groups were:~Treatment B (CHF 718 pMDI 400 µg TDD) vs Treatment A (CHF 718 pMDI 100 µg TDD)"||0.169|-0.019|0.119
72514749|NCT03084718|144560714|SUPERIORITY||Mean Difference (Final Values)|0.022||||0.638|TWO_SIDED|95.0|-0.071|0.116|||Mixed Models Analysis|||"Week 8~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment A (CHF 718 pMDI 100 µg TDD)"||0.116|-0.071|0.638
72514750|NCT03084718|144560714|SUPERIORITY||Mean Difference (Final Values)|-0.052||||0.274|TWO_SIDED|95.0|-0.147|0.042|||Mixed Models Analysis|||"Week 8~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment B (CHF 718 pMDI 400 µg TDD)"||0.042|-0.147|0.274
72514751|NCT03084718|144560714|SUPERIORITY||Mean Difference (Final Values)|0.079||||0.092|TWO_SIDED|95.0|-0.013|0.171|||Mixed Models Analysis|||"Week 8~Comparison treatment groups were:~Treatment E (QVAR\^®, 320 µg TDD) vs Treatment D (Placebo)"||0.171|-0.013|0.092
72514752|NCT03084718|144560715|SUPERIORITY||Mean Difference (Final Values)|-0.15||||0.053|TWO_SIDED|95.0|-0.31|0.0|||Mixed Models Analysis|||"Week 4~Comparison treatment groups were:~Treatment A (CHF 718 pMDI 100 µg TDD) vs Treatment D (Placebo)"||0.00|-0.31|0.053
72514753|NCT03084718|144560715|SUPERIORITY||Mean Difference (Final Values)|-0.26||||0.001|TWO_SIDED|95.0|-0.42|-0.11|||Mixed Models Analysis|||"Week 4~Comparison treatment groups were:~Treatment B (CHF 718 pMDI 400 µg TDD) vs Treatment D (Placebo)"||-0.11|-0.42|0.001
72514754|NCT03084718|144560715|SUPERIORITY||Mean Difference (Final Values)|-0.22||||0.006|TWO_SIDED|95.0|-0.37|-0.06|||Mixed Models Analysis|||"Week 4~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment D (Placebo)"||-0.06|-0.37|0.006
72514755|NCT03084718|144560715|SUPERIORITY||Mean Difference (Final Values)|-0.11||||0.176|TWO_SIDED|95.0|-0.26|0.05|||Mixed Models Analysis|||"Week 4~Comparison treatment groups were:~Treatment B (CHF 718 pMDI 400 µg TDD) vs Treatment A (CHF 718 pMDI 100 µg TDD)"||0.05|-0.26|0.176
72514756|NCT03084718|144560715|SUPERIORITY||Mean Difference (Final Values)|-0.06||||0.423|TWO_SIDED|95.0|-0.22|0.09|||Mixed Models Analysis|||"Week 4~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment A (CHF 718 pMDI 100 µg TDD)"||0.09|-0.22|0.423
72514757|NCT03084718|144560715|SUPERIORITY||Mean Difference (Final Values)|0.04||||0.574|TWO_SIDED|95.0|-0.11|0.2|||Mixed Models Analysis|||"Week 4~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment B (CHF 718 pMDI 400 µg TDD)"||0.20|-0.11|0.574
72514758|NCT03084718|144560715|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.011|TWO_SIDED|95.0|-0.35|-0.05|||Mixed Models Analysis|||"Week 4~Comparison treatment groups were:~Treatment E (QVAR\^®, 320 µg TDD) vs Treatment D (Placebo)"||-0.05|-0.35|0.011
72514759|NCT03084718|144560715|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.215|TWO_SIDED|95.0|-0.27|0.06|||Mixed Models Analysis|||"Week 8~Comparison treatment groups were:~Treatment A (CHF 718 pMDI 100 µg TDD) vs Treatment D (Placebo"||0.06|-0.27|0.215
72514760|NCT03084718|144560715|SUPERIORITY||Mean Difference (Final Values)|-0.15||||0.07|TWO_SIDED|95.0|-0.32|0.01|||Mixed Models Analysis|||"Week 8~Comparison treatment groups were:~Treatment B (CHF 718 pMDI 400 µg TDD) vs Treatment D (Placebo)"||0.01|-0.32|0.070
72514761|NCT03084718|144560715|SUPERIORITY||Mean Difference (Final Values)|-0.23||||0.005|TWO_SIDED|95.0|-0.4|-0.07|||Mixed Models Analysis|||"Week 8~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment D (Placebo)"||-0.07|-0.40|0.005
72514762|NCT03084718|144560715|SUPERIORITY||Mean Difference (Final Values)|-0.05||||0.566|TWO_SIDED|95.0|-0.21|0.12|||Mixed Models Analysis|||"Week 8~Comparison treatment groups were:~Treatment B (CHF 718 pMDI 400 µg TDD) vs Treatment A (CHF 718 pMDI 100 µg TDD)"||0.12|-0.21|0.566
72514763|NCT03084718|144560715|SUPERIORITY||Mean Difference (Final Values)|-0.13||||0.124|TWO_SIDED|95.0|-0.29|0.04|||Mixed Models Analysis|||"Week 8~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment A (CHF 718 pMDI 100 µg TDD)"||0.04|-0.29|0.124
72514764|NCT03084718|144560715|SUPERIORITY||Mean Difference (Final Values)|-0.08||||0.336|TWO_SIDED|95.0|-0.25|0.08|||Mixed Models Analysis|||"Week 8~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment B (CHF 718 pMDI 400 µg TDD)"||0.08|-0.25|0.336
72514765|NCT03084718|144560715|SUPERIORITY||Mean Difference (Final Values)|-0.21||||0.01|TWO_SIDED|95.0|-0.37|-0.05|||Mixed Models Analysis|||"Week 8~Comparison treatment groups were:~Treatment E (QVAR\^®, 320 µg TDD) vs Treatment D (Placebo)"||-0.05|-0.37|0.010
72514766|NCT03084718|144560716|SUPERIORITY||Mean Difference (Final Values)|-0.18||||0.067|TWO_SIDED|95.0|-0.38|0.01|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups were:~Treatment A (CHF 718 pMDI 100 µg TDD) vs Treatment D (Placebo)"||0.01|-0.38|0.067
72514767|NCT03084718|144560716|SUPERIORITY||Mean Difference (Final Values)|-0.34|||<|0.001|TWO_SIDED|95.0|-0.53|-0.14|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups were:~Treatment B (CHF 718 pMDI 400 µg TDD) vs Treatment D (Placebo)"||-0.14|-0.53|< 0.001
72514768|NCT03084718|144560716|SUPERIORITY||Mean Difference (Final Values)|-0.21||||0.038|TWO_SIDED|95.0|-0.4|-0.01|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment D (Placebo)"||-0.01|-0.40|0.038
72514769|NCT03084718|144560716|SUPERIORITY||Mean Difference (Final Values)|-0.15||||0.13|TWO_SIDED|95.0|-0.35|0.05|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups were:~Treatment B (CHF 718 pMDI 400 µg TDD) vs Treatment A (CHF 718 pMDI 100 µg TDD)"||0.05|-0.35|0.130
72403392|NCT03450707|144312511|OTHER||Mean Difference (Final Values)|-1.0||||0.43|TWO_SIDED|95.0|-3.6|1.6||Mixed model controlling for repeated measures within patients used to get a mean difference in Basal Respiration between the thiamine and placebo groups at 24 hours.|Mixed Models Analysis|P-value is the global p-value from the mixed model. P-value is obtained from a model that uses a log-transformed version of the variable.|Mean difference uses a non-logged version of the variable.|||1.6|-3.6|0.43
72403393|NCT03450707|144312512|OTHER||Mean Difference (Final Values)|0.76||||0.02|TWO_SIDED|95.0|-0.27|1.78||Mixed model controlling for repeated measures within patients used to get a mean difference in creatinine between the thiamine and placebo groups at 72 hours.|Mixed Models Analysis|P-value is the global p-value from the mixed model. P-value is obtained from a model that uses a log-transformed version of the variable.||||1.78|-0.27|0.02
72403394|NCT00481195|144312514|SUPERIORITY_OR_OTHER|||||||0.0439||95.0|||||ANOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group and the p-value for the treatment comparison is from an analysis of variance (ANOVA) with treatment ands concurrent treatment for bipolar disorders as factors. A significant treatment-by baseline interaction was observed in the total score that violates the assumption of parallelism on which an ANCOVA is based, so the data was analyzed using ANOVA without baseline as a covariate rather than ANCOVA.||||0.0439
72403395|NCT00481195|144312515|SUPERIORITY_OR_OTHER|||||||0.0795||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group and the p-value for the treatment comparison is from an ANCOVA with treatment and concurrent treatment for bipolar disorder as factors, and the baseline value as covariate.||||0.0795
72403396|NCT00481195|144312516|SUPERIORITY_OR_OTHER|||||||0.0272||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group and the p-value for the treatment comparison is from an ANCOVA with treatment and concurrent treatment for bipolar disorder as factors, and the baseline value as covariate.||||0.0272
72403397|NCT00481195|144312517|SUPERIORITY_OR_OTHER|||||||0.0802||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group and the p-value for the treatment comparison is from an ANCOVA with treatment and concurrent treatment for bipolar disorder as factors, and the baseline value as covariate.||||0.0802
72487831|NCT00916149|144504231|OTHER|||||||0.039|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the Verbal Working Memory Accuracy score from pre to post time points in the levetiracetam treatment group||||0.039
72487832|NCT00916149|144504232|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the Verbal Working Memory Reaction Time from pre to post time points in the no treatment group||||>0.05
72487833|NCT00916149|144504232|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the Verbal Working Memory Reaction Time from pre to post time points in the levetiracetam treatment group||||>0.05
72487834|NCT00916149|144504233|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the Non-verbal Working Memory Accuracy score from pre to post time points in the no treatment group||||>0.05
72487835|NCT00916149|144504233|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the Non-verbal Working Memory Accuracy score from pre to post time points in the levetiracetam treatment group||||>0.05
72577097|NCT00580788|144680814|NON_INFERIORITY_OR_EQUIVALENCE|The study was designed as a standard dose-escalation study, dose-finding pilot study. The primary outcome measures were safety (hypercalcemia, hypophosphatemia and symptoms/hemodynamic measurements). A modified Fibronacci dose-escalation scheme was employed.|||||<|0.0001|TWO_SIDED|||||The reported p-value corresponds to the increase over time for the PTHrP 4 pmol group.|Mixed Models Analysis|Value The level of statistical significance was set at .05 (two-tailed)||||||<0.0001
72487836|NCT00916149|144504234|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the Non-verbal Working Memory Reaction Time from pre to post time points in the no treatment group||||>0.05
72487837|NCT00916149|144504234|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the Non-verbal Working Memory Reaction Time from pre to post time points in the levetiracetam treatment group||||>0.05
72487838|NCT00916149|144504235|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the Verbal Recognition Accuracy score from pre to post time points in the no treatment group||||>0.05
72487839|NCT00916149|144504235|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the Verbal Recognition Accuracy score from pre to post time points in the levetiracetam treatment group||||>0.05
72487840|NCT00916149|144504236|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the Verbal Recognition Reaction Time from pre to post time points in the no treatment group||||>0.05
72487841|NCT00916149|144504236|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the Verbal Recognition Reaction Time from pre to post time points in the levetiracetam treatment group||||>0.05
72487842|NCT00916149|144504237|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the Facial Recognition Accuracy score from pre to post time points in the no treatment group||||>0.05
72487843|NCT00916149|144504237|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the Facial Recognition Accuracy score from pre to post time points in the levetiracetam treatment group||||>0.05
72487844|NCT00916149|144504238|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the Facial Recognition Reaction Time from pre to post time points in the no treatment group||||>0.05
72487845|NCT00916149|144504238|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the Facial Recognition Reaction Time from pre to post time points in the levetiracetam treatment group||||>0.05
72487846|NCT00916149|144504239|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the NDDIE score from pre to post time points in the no treatment group||||>0.05
72487847|NCT00916149|144504239|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the NDDIE score from pre to post time points in the levetiracetam treatment group||||>0.05
72487848|NCT00916149|144504240|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the AEP score from pre to post time points in the no treatment group||||>0.05
72487849|NCT00916149|144504240|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the AEP score from pre to post time points in the levetiracetam treatment group||||>0.05
72577098|NCT00580788|144680815|NON_INFERIORITY_OR_EQUIVALENCE|The study was designed as a standard dose-escalation study, dose-finding pilot study. The primary outcome measures were safety (hypercalcemia, hypophosphatemia and symptoms/hemodynamic measurements). A modified Fibronacci dose-escalation scheme was employed.|||||<|0.0001|TWO_SIDED|||||The reported p-value corresponds to the increase over time for the PTHrP 4 pmol group.|Mixed Models Analysis|The level of statistical significance was set at .05 (two-tailed)||||||<0.0001
72403398|NCT00481195|144312518|SUPERIORITY_OR_OTHER|||||||0.2407||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group and the p-value for the treatment comparison is from an ANCOVA with treatment and concurrent treatment for bipolar disorder as factors, and the baseline value as covariate.||||0.2407
72487850|NCT01940471|144504250|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Sample sizes of 288 and 576 participants in the TDF and TAF groups, respectively, were planned to give 84% power to rule out the noninferiority margin of 10% at a 1-sided significance level of 0.025. This sample size based on the assumption that the expected difference (TAF - TDF) in the proportion of participants with HBV DNA \< 29 IU/mL was 0 and the proportion of participants with HBV DNA \< 29 IU/mL in the TDF group was 69%. Missing data were treated as not achieving the primary endpoint.|Difference in proportions|-3.6|||||TWO_SIDED|95.0|-9.8|2.6|||||Difference in the proportion between treatment groups and its 95% CI were calculated based on the Mantel-Haenszel (MH) proportions adjusted by baseline HBV DNA categories and oral antiviral treatment status strata.|The null hypothesis was that the TAF group is at least 10% worse than the TDF group with respect to the proportion of participants with HBV DNA \< 29 IU/mL at Week 48. The alternative hypothesis was that the TAF group is less than 10% worse than the TDF group with respect to the proportion of participants with HBV DNA \< 29 IU/mL at Week 48. Noninferiority was assessed using a 95% confidence interval (CI) approach, with a noninferiority margin of 10%.||2.6|-9.8|
72487851|NCT03184077|144504298|SUPERIORITY|||||||0.16|||||||Chi-squared|||||||0.16
72487852|NCT03184077|144504299|SUPERIORITY|||||||0.62|||||||Chi-squared|||||||0.62
72487853|NCT03184077|144504300|SUPERIORITY|||||||0.01||||||This is a calculated p value|Chi-squared|||||||0.01
72487854|NCT03462719|144504301|SUPERIORITY||Hazard Ratio (HR)|0.216|||<|0.0001|TWO_SIDED|95.0|0.131|0.357|||Log Rank|||||0.357|0.131|<0.0001
72487855|NCT02046096|144504316|OTHER||12-month rate (%)|97.8|||<|0.0001|TWO_SIDED|95.0|95.6|99.1||The threshold for statistical significance was p = 0.025|One-tailed Exact binomial test||The 95% confidence interval was computed using Exact method.|Null Hypothesis: The rate of technical placement success and 12-month freedom from new symptomatic PE while a filter is indwelling, π, does not meet the performance goal (90%).||99.1|95.6|<0.0001
72487856|NCT02046096|144504317|OTHER||Cumulative probability|81.5|STANDARD_ERROR_OF_MEAN|4.5||0.369|TWO_SIDED|95.0|72.6|90.4||the threshold for statistical significance is 0.025.|Z-statistic|The hypothesis is assessed using a Z-statistic. The Z-statistic is given by Z = (Ŝ(t) - 0.8) / SE where SE is the Standard Error|The estimate of the variance of the Kaplan-Meier estimate used the methods described by Peto et al.|"the null hypotheses is: H0: S(t) ≤ 80%(Performance Goal) where,~* t is time through 12 months~* S(t) is the true rate of freedom from major adverse events at time t."||90.4|72.6|0.369
72487857|NCT02046096|144504318|OTHER||12-month freedom from MAE rate (%)|86.7||||0.001|TWO_SIDED|95.0|82.5|90.2||The threshold for statistical significance was p = 0.025|One-tailed exact binomial test|||Null Hypothesis: The 12-month freedom from MAE, π, does not meet the performance goal (80%).||90.2|82.5|0.001
72487858|NCT01401842|144504325|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED||||||Mixed Models Analysis|||For the primary hypothesis, differences at follow-up between the two groups on lumbar extension muscular strength (Nm) were analyzed using linear mixed-effects regression models, accounting for the effects of cluster (platoon) and adjusting for baseline measures. The linear mixed-effects model treats the data as two levels (level 1 for individuals, level 2 for clusters), while also taking into account between-cluster variation.||||0.001
72487859|NCT01401842|144504326|SUPERIORITY_OR_OTHER|||||||0.871|TWO_SIDED||||||Mixed Models Analysis|||For the primary hypothesis, differences at follow-up between the two groups on core muscular endurance (seconds) were analyzed using linear mixed-effects regression models, accounting for the effects of cluster (platoon) and adjusting for baseline measures. The linear mixed-effects model treats the data as two levels (level 1 for individuals, level 2 for clusters), while also taking into account between-cluster variation.||||0.871
72487860|NCT01401842|144504327|SUPERIORITY_OR_OTHER|||||||0.021|TWO_SIDED||||||Mixed Models Analysis|||For the primary hypothesis, differences at follow-up between the two groups on core muscular endurance (seconds) were analyzed using linear mixed-effects regression models, accounting for the effects of cluster (platoon) and adjusting for baseline measures. The linear mixed-effects model treats the data as two levels (level 1 for individuals, level 2 for clusters), while also taking into account between-cluster variation.||||0.021
72514770|NCT03084718|144560716|SUPERIORITY||Mean Difference (Final Values)|-0.02||||0.811|TWO_SIDED|95.0|-0.22|0.17|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment A (CHF 718 pMDI 100 µg TDD)"||0.17|-0.22|0.811
72514771|NCT03084718|144560716|SUPERIORITY||Mean Difference (Final Values)|0.13||||0.202|TWO_SIDED|95.0|-0.07|0.33|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment B (CHF 718 pMDI 400 µg TDD)"||0.33|-0.07|0.202
72514772|NCT03084718|144560716|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.044|TWO_SIDED|95.0|-0.39|-0.01|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups were:~Treatment E (QVAR\^®, 320 µg TDD) vs Treatment D (Placebo)"||-0.01|-0.39|0.044
72514773|NCT03084718|144560716|SUPERIORITY||Mean Difference (Final Values)|-0.13||||0.283|TWO_SIDED|95.0|-0.37|0.11|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups were:~Treatment A (CHF 718 pMDI 100 µg TDD) vs Treatment D (Placebo)"||0.11|-0.37|0.283
72487861|NCT02971631|144504336|SUPERIORITY|||||||0.008|||||||t-test, 2 sided|Paired analysis||||||0.008
72487862|NCT02971631|144504337|SUPERIORITY|||||||0.03|||||||t-test, 2 sided|Paired analysis||||||0.03
72514774|NCT03084718|144560716|SUPERIORITY||Mean Difference (Final Values)|-0.37||||0.003|TWO_SIDED|95.0|-0.6|-0.13|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups were:~Treatment B (CHF 718 pMDI 400 µg TDD) vs Treatment D (Placebo)"||-0.13|-0.60|0.003
72514775|NCT03084718|144560716|SUPERIORITY||Mean Difference (Final Values)|-0.27||||0.027|TWO_SIDED|95.0|-0.5|-0.03|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment D (Placebo)"||-0.03|-0.50|0.027
72487863|NCT02971631|144504338|SUPERIORITY|||||||0.79|||||||t-test, 2 sided|Paired analysis||For meal consumption rate||||0.79
72487864|NCT02971631|144504340|SUPERIORITY|||||||0.2|||||||t-test, 2 sided|Paired analysis||Baseline||||0.20
72403399|NCT00481195|144312519|SUPERIORITY_OR_OTHER|||||||0.0502||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group and the p-value for the treatment comparison is from an ANCOVA with treatment and concurrent treatment for bipolar disorder as factors, and the baseline value as covariate.||||0.0502
72514776|NCT03084718|144560716|SUPERIORITY||Mean Difference (Final Values)|-0.24||||0.054|TWO_SIDED|95.0|-0.48|0.0|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups were:~Treatment B (CHF 718 pMDI 400 µg TDD) vs Treatment A (CHF 718 pMDI 100 µg TDD)"||0.00|-0.48|0.054
72403400|NCT00481195|144312520|SUPERIORITY_OR_OTHER|||||||0.0612||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group and the p-value for the treatment comparison is from an ANCOVA with treatment and concurrent treatment for bipolar disorder as factors, and the baseline value as covariate.||||0.0612
72514777|NCT03084718|144560716|SUPERIORITY||Mean Difference (Final Values)|-0.14||||0.258|TWO_SIDED|95.0|-0.38|0.1|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment A (CHF 718 pMDI 100 µg TDD)"||0.10|-0.38|0.258
72514778|NCT03084718|144560716|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.423|TWO_SIDED|95.0|-0.14|0.34|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment B (CHF 718 pMDI 400 µg TDD)"||0.34|-0.14|0.423
72487865|NCT02971631|144504340|SUPERIORITY|||||||0.58|||||||t-test, 2 sided|Paired analysis||Post-OGTT||||0.58
72487866|NCT02971631|144504340|SUPERIORITY|||||||0.39|||||||t-test, 2 sided|Paired analysis||Pre-meal||||0.39
72487867|NCT02971631|144504340|SUPERIORITY|||||||0.2|||||||t-test, 2 sided|Paired analysis||Post-meal||||0.20
72487868|NCT02971631|144504341|SUPERIORITY|||||||0.26|||||||t-test, 2 sided|Paired analysis||Baseline||||0.26
72487869|NCT02971631|144504341|SUPERIORITY|||||||0.06||||||Paired analysis|t-test, 2 sided|||Post-OGTT||||0.06
72487870|NCT02971631|144504341|SUPERIORITY|||||||0.95|||||||t-test, 2 sided|Paired analysis||Pre-meal||||0.95
72487871|NCT02971631|144504341|SUPERIORITY|||||||0.88|||||||t-test, 2 sided|Paired analysis||Post-meal||||0.88
72487872|NCT02971631|144504342|SUPERIORITY|||||||1|||||||Other|0 events over whole study, no statistical test appropriate||||||1
72487873|NCT02971631|144504343|SUPERIORITY|||||||0.84|||||||t-test, 2 sided|||||||0.84
72487874|NCT00847145|144504369|NON_INFERIORITY_OR_EQUIVALENCE|The specified cut-off levels for the vaccine antigen measles is ≥255 mIU/mL to be greater than -10%.|Percentage group difference|-1.0|||||TWO_SIDED|95.0|-5.0|2.0||||||The immunogenicity in 12B12M (1a) group was considered non-inferior to that in group 12M13B15B (2a), if for the measles antigen (two months after the MMRV vaccine), the lower limit of the two-sided 95% CI for the difference in the percentages of subjects with antibody response greater than or equal to the specified cut-off level for Measles antigen was greater than -10%.||2|-5|
72487875|NCT00847145|144504369|NON_INFERIORITY_OR_EQUIVALENCE|The specified cut-off level for the vaccine antigen mumps is ≥10 Enzyme Linked Immunosorbent Assay(ELISA) Antibody (Ab) units to be greater than -10%.|Percentage group difference|0.0|||||TWO_SIDED|95.0|-5.0|5.0||||||The immunogenicity in 12B12M(1a) group was considered non-inferior to that in group 12M13B15B(2a), if for the mumps antigen (two months after the MMRV vaccine), the lower limit of the two-sided 95% CI for the difference in the percentages of subjects with antibody response greater than or equal to the specified cut-off level for Mumps antigen was greater than -10%.||5|-5|
72487876|NCT00847145|144504369|NON_INFERIORITY_OR_EQUIVALENCE|The specified cut-off level for the vaccine antigen rubella is ≥10 IU/mL to be greater than -10%.|Percentage group difference|-1.0|||||TWO_SIDED|95.0|-4.0|1.0||||||The immunogenicity in 12B12M(1a) group was considered non-inferior to that in group 12M13B15B (2a), if for the rubella antigen(two months after the MMRV vaccine), the lower limit of the two-sided 95% CI for the difference in the percentages of subjects with antibody response greater than or equal to the specified cut-off level for rubella antigen was greater than -10%.||1|-4|
72487877|NCT00847145|144504369|NON_INFERIORITY_OR_EQUIVALENCE|The specified cut-off value for the vaccine antigen varicella is ≥1.25 gpELISA units/mL to be greater than -10%.|Percentage group difference|-1.0|||||TWO_SIDED|95.0|-6.0|3.0||||||The immunogenicity in 12B12M(1a) group was considered non-inferior to that in group 12M13B15B (2a), if for the varicella antigen (two months after the MMRV vaccine), the lower limit of the two-sided 95% CI for the difference in the percentages of subjects with antibody response greater than or equal to the specified cut-off level for varicella antigen was greater than -10%.||3|-6|
72487878|NCT00847145|144504369|NON_INFERIORITY_OR_EQUIVALENCE|The specified cut-off level for the varicella vaccine antigen is ≥5 gp ELISA units/ml (seroprotection) to be greater than -10%.|Percentage group difference|-2.0|||||TWO_SIDED|95.0|-11.0|7.0||||||The immunogenicity in 12B12M (1a) group was considered non-inferior to that in group 12M13B15B (2), if for the varicella antigen (two months after the MMRV vaccine), the lower limit of the two-sided 95% CI for the difference in the percentages of the subjects with antibody response greater than or equal to the specified cut-off value for varicella antigen was greater than -10%.||7|-11|
72487879|NCT00307151|144504396|SUPERIORITY_OR_OTHER||Risk Difference (RD)|18.6||||0.015|TWO_SIDED|95.0|3.7|33.6||P-value not adjusted for multiple interim analyses, but adjustment would be negligible because Peto-Haybittle spending function used as basis for calculating repeated confidence intervals used in interim monitoring.|t-test, 2 sided|Risk difference estimate stratified by age (\<12 months vs. \>=12 months)and reports rate on NVP arm minus rate on LPV/r arm|Endpoint rates with standard errors calculated from Kaplan-Meier curves for each treatment group and age stratum. Differences in week 24 failure proportions by treatment calculated weighted by the inverse of the variance in each age stratum.|||33.6|3.7|0.015
72487880|NCT00307151|144504396|SUPERIORITY_OR_OTHER||Risk Difference (RD)|21.5|||<|0.001|TWO_SIDED|95.0|11.2|31.8||P-value not adjusted for multiple interim analyses, but adjustment would be negligible because Peto-Haybittle spending function used as basis for calculating repeated confidence intervals used in interim monitoring.|t-test, 2 sided|Risk difference estimate stratified by age (\<12 months vs. \>=12 months) and reports rate on NVP arm minus rate on LPV/r arm|Endpoint rates with standard errors calculated from Kaplan-Meier curves for each treatment group and age stratum. Differences in week 24 failure proportions by treatment calculated weighted by the inverse of the variance in each age stratum.|||31.8|11.2|<0.001
72487881|NCT03600142|144504407|NON_INFERIORITY|For WLHIV (n=55), chi-square tests were used to assess differences between conditions in the proportion of participants who were retained in HIV care at 3 months post enrollment.||||||0.963|||||||Chi-squared|||We were aware that our resources of time and funding would not be sufficient to detect a significant difference in the HIV care outcome, and that we would only be able to detect observational signals of impact. We aimed for a minimum of 50 WLHIV, which is considered an adequate sample to assess feasibility and acceptability in a pilot intervention study. Given an estimated 5% HIV prevalence among women presenting for ANC, this required us to enroll 1000 female participants.||||0.963
72403401|NCT00481195|144312521|SUPERIORITY_OR_OTHER|||||||0.198||95.0||||P-value is from a Cochran-Mantel-Haenzel chi-square test adjusted for concurrent treatment for bipolar disorder|Cochran-Mantel-Haenszel|||||||0.1980
72487882|NCT02081534|144504450|SUPERIORITY|||||||0.012|||||||ANCOVA|||||||0.012
72487883|NCT01360554|144504470|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.933||||0.195|TWO_SIDED|95.0|0.797|1.093||One-sided P-value.|1-sided stratified log-rank test|Stratified by epidermal growth factor receptor (EGFR) status, Kirsten Rat Sarcoma status (KRAS), baseline Eastern Cooperative Oncology Group (ECOG).|The HR (Dacomitinib arm versus erlotinib arm) and 95% CI were estimated from stratified Cox regression with EGFR status, KRAS, baseline ECOG as stratification factors.|||1.093|0.797|0.195
72487884|NCT01360554|144504471|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.037||||0.643|TWO_SIDED|95.0|0.848|1.268||One-sided P-value|1-sided stratified log-rank test|Stratified by EGFR status and baseline ECOG.|The HR (Dacomitinib arm versus erlotinib arm) and 95% CI were estimated from stratified Cox regression with EGFR status and baseline ECOG as stratification factors.|||1.268|0.848|0.643
72487885|NCT01360554|144504472|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.899||||0.069|TWO_SIDED|95.0|0.78|1.035||Stratified by EGFR status, KRAS status, and baseline ECOG.|1-sided stratified log-rank test|One-sided P-value|The HR (Dacomitinib arm versus erlotinib arm) and 95% CI were estimated from stratified Cox regression with EGFR status, KRAS status, and baseline ECOG as stratification factors.|||1.035|0.780|0.069
72487886|NCT01360554|144504473|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.057||||0.728|TWO_SIDED|95.0|0.881|1.267||One-sided P-value.|1-sided stratified log-rank test|Stratified by EGFR status and baseline ECOG.|The HR (Dacomitinib arm versus erlotinib arm) and 95% CI were estimated from stratified Cox regression with EGFR status and baseline ECOG as stratification factors.|||1.267|0.881|0.728
72514779|NCT03084718|144560716|SUPERIORITY||Mean Difference (Final Values)|-0.19||||0.111|TWO_SIDED|95.0|-0.42|0.04|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups were:~Treatment E (QVAR\^®, 320 µg TDD) vs Treatment D (Placebo)"||0.04|-0.42|0.111
72487887|NCT01360554|144504474|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.026||||0.638|TWO_SIDED|95.0|0.887|1.188||One-sided P-value.|1-sided stratified log-rank test.|Stratified by EGFR status, KRAS status, and baseline ECOG.|The HR (Dacomitinib arm versus erlotinib arm) and 95% CI were estimated from stratified Cox regression with EGFR status, KRAS status, and baseline ECOG as stratification factors.|||1.188|0.887|0.638
72487888|NCT01360554|144504475|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.078||||0.775|TWO_SIDED|95.0|0.886|1.312||One-sided P-value.|1-sided stratified log-rank test.|Stratified by EGFR status and baseline ECOG.|The HR (Dacomitinib arm versus erlotinib arm) and 95% CI were estimated from stratified Cox regression with EGFR status and baseline ECOG as stratification factors.|||1.312|0.886|0.775
72487889|NCT01360554|144504483|SUPERIORITY_OR_OTHER||Repeated measures mixed-effects model.|-1.9357||||||95.0|-4.278|0.407|||||This analysis represents the mean difference between the dacomitinib arm (Arm A) and the erlotinib arm (Arm B).|Analysis presented for QLQ-C30 Global QoL. Mean difference was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-C30 subscale baseline score (intercept and time from first dose are included as random effects). Confidence intervals provided were not adjusted for multiplicity.||0.407|-4.278|
72487890|NCT01360554|144504483|SUPERIORITY_OR_OTHER||Repeated measures mixed-effects model.|0.8067||||||95.0|-1.312|2.926|||||This analysis represents the mean difference between the dacomitinib arm (Arm A) and the erlotinib arm (Arm B).|Analysis presented for QLQ-C30 cognitive functioning. Mean difference was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-C30 subscale baseline score (intercept and time from first dose are included as random effects). Confidence intervals provided were not adjusted for multiplicity.||2.926|-1.312|
72487891|NCT01360554|144504483|SUPERIORITY_OR_OTHER||Repeated measures mixed-effects model|0.73||||||95.0|-1.575|3.035|||||This analysis represents the mean difference between the dacomitinib arm (Arm A) and the erlotinib arm (Arm B).|Analysis presented for QLQ-C30 emotional functioning. Mean difference was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-C30 subscale baseline score (intercept and time from first dose are included as random effects). Confidence intervals provided were not adjusted for multiplicity.||3.035|-1.575|
72514780|NCT03084718|144560716|SUPERIORITY||Mean Difference (Final Values)|-0.16||||0.135|TWO_SIDED|95.0|-0.36|0.05|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups were:~Treatment A (CHF 718 pMDI 100 µg TDD) vs Treatment D (Placebo)"||0.05|-0.36|0.135
72514781|NCT03084718|144560716|SUPERIORITY||Mean Difference (Final Values)|-0.35|||<|0.001|TWO_SIDED|95.0|-0.56|-0.14|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups were:~Treatment B (CHF 718 pMDI 400 µg TDD) vs Treatment D (Placebo)"||-0.14|-0.56|< 0.001
72514782|NCT03084718|144560716|SUPERIORITY||Mean Difference (Final Values)|-0.24||||0.024|TWO_SIDED|95.0|-0.44|-0.03|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment D (Placebo)"||-0.03|-0.44|0.024
72487892|NCT01360554|144504483|SUPERIORITY_OR_OTHER||Repeated measures mixed-effects model.|1.5289||||||95.0|-0.756|3.814|||||This analysis represents the mean difference between the dacomitinib arm (Arm A) and the erlotinib arm (Arm B).|Analysis presented for QLQ-C30 physical functioning. Mean difference was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-C30 subscale baseline score (intercept and time from first dose are included as random effects). Confidence intervals provided were not adjusted for multiplicity.||3.814|-0.756|
72487893|NCT01360554|144504483|SUPERIORITY_OR_OTHER||Repeated measures mixed-effects model.|1.2219||||||95.0|-1.975|4.419|||||This analysis represents the mean difference between the dacomitinib arm (Arm A) and the erlotinib arm (Arm B).|Analysis presented for QLQ-C30 role functioning. Mean difference was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-C30 subscale baseline score (intercept and time from first dose are included as random effects). Confidence intervals provided were not adjusted for multiplicity.||4.419|-1.975|
72487894|NCT01360554|144504483|SUPERIORITY_OR_OTHER||Repeated measures mixed-effects model.|-1.497||||||95.0|-4.575|1.581|||||This analysis represents the mean difference between the dacomitinib arm (Arm A) and the erlotinib arm (Arm B).|Analysis presented for QLQ-C30 social functioning. Mean difference was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-C30 subscale baseline score (intercept and time from first dose are included as random effects). Confidence intervals provided were not adjusted for multiplicity.||1.581|-4.575|
72487895|NCT01360554|144504484|SUPERIORITY_OR_OTHER||Repeated measures mixed-effects model.|1.2851|||||TWO_SIDED|95.0|-2.416|4.986|||||This analysis represents the mean difference between the dacomitinib arm (Arm A) and the erlotinib arm (Arm B).|Analysis presented for QLQ-C30 Appetite loss. Mean difference was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-C30 subscale baseline score (intercept and time from first dose are included as random effects). Confidence intervals provided were not adjusted for multiplicity.||4.986|-2.416|
72487896|NCT01360554|144504484|SUPERIORITY_OR_OTHER||Repeated measures mixed-effects model.|-5.923|||||TWO_SIDED|95.0|-8.432|-3.414|||||This analysis represents the mean difference between the dacomitinib arm (Arm A) and the erlotinib arm (Arm B).|Analysis presented for QLQ-C30 Constipation. Mean difference was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-C30 subscale baseline score (intercept and time from first dose are included as random effects). Confidence intervals provided were not adjusted for multiplicity.||-3.414|-8.432|
72487897|NCT01360554|144504484|SUPERIORITY_OR_OTHER||Repeated measures mixed-effects model|20.2564|||||TWO_SIDED|95.0|16.874|23.639|||||This analysis represents the mean difference between the dacomitinib arm (Arm A) and the erlotinib arm (Arm B).|Analysis presented for QLQ-C30 Diarrhea. Mean difference was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-C30 subscale baseline score (intercept and time from first dose are included as random effects). Confidence intervals provided were not adjusted for multiplicity.||23.639|16.874|
72487898|NCT01360554|144504484|SUPERIORITY_OR_OTHER||Repeated measures mixed-effects model.|-4.5499|||||TWO_SIDED|95.0|-7.719|-1.381|||||This analysis represents the mean difference between the dacomitinib arm (Arm A) and the erlotinib arm (Arm B).|Analysis presented for QLQ-C30 Dysponea. Mean difference was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-C30 subscale baseline score (intercept and time from first dose are included as random effects). Confidence intervals provided were not adjusted for multiplicity.||-1.381|-7.719|
72487899|NCT01360554|144504484|SUPERIORITY_OR_OTHER||Repeated measures mixed-effects model.|-1.6584|||||TWO_SIDED|95.0|-4.442|1.125|||||This analysis represents the mean difference between the dacomitinib arm (Arm A) and the erlotinib arm (Arm B).|Analysis presented for QLQ-C30 Fatigue. Mean difference was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-C30 subscale baseline score (intercept and time from first dose are included as random effects). Confidence intervals provided were not adjusted for multiplicity.||1.125|-4.442|
72487900|NCT01360554|144504484|SUPERIORITY_OR_OTHER||Repeated measures mixed-effects model.|-0.1469||||||95.0|-3.056|2.762|||||This analysis represents the mean difference between the dacomitinib arm (Arm A) and the erlotinib arm (Arm B).|Analysis presented for QLQ-C30 Financial Difficulties. Mean difference was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-C30 subscale baseline score (intercept and time from first dose are included as random effects). Confidence intervals provided were not adjusted for multiplicity.||2.762|-3.056|
72487901|NCT01360554|144504484|SUPERIORITY_OR_OTHER||Repeated measures mixed-effects model.|-4.8711|||||TWO_SIDED|95.0|-7.998|-1.745|||||This analysis represents the mean difference between the dacomitinib arm (Arm A) and the erlotinib arm (Arm B).|Analysis presented for QLQ-C30 Insomnia. Mean difference was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-C30 subscale baseline score (intercept and time from first dose are included as random effects). Confidence intervals provided were not adjusted for multiplicity.||-1.745|-7.998|
72487902|NCT01360554|144504484|SUPERIORITY_OR_OTHER||Repeated measures mixed-effects model.|-0.4924|||||TWO_SIDED|95.0|-2.485|1.5|||||This analysis represents the mean difference between the dacomitinib arm (Arm A) and the erlotinib arm (Arm B).|Analysis presented for QLQ-C30 Nausea and Vomiting. Mean difference was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-C30 subscale baseline score (intercept and time from first dose are included as random effects). Confidence intervals provided were not adjusted for multiplicity.||1.500|-2.485|
72487903|NCT01360554|144504484|SUPERIORITY_OR_OTHER||Repeated measures mixed-effects model.|0.3096|||||TWO_SIDED|95.0|-2.646|3.265|||||This analysis represents the mean difference between the dacomitinib arm (Arm A) and the erlotinib arm (Arm B).|Analysis presented for QLQ-C30 Pain. Mean difference was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-C30 subscale baseline score (intercept and time from first dose are included as random effects). Confidence intervals provided were not adjusted for multiplicity.||3.265|-2.646|
72514783|NCT03084718|144560716|SUPERIORITY||Mean Difference (Final Values)|-0.19||||0.067|TWO_SIDED|95.0|-0.4|0.01|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups were:~Treatment B (CHF 718 pMDI 400 µg TDD) vs Treatment A (CHF 718 pMDI 100 µg TDD)"||0.01|-0.40|0.067
72514784|NCT03084718|144560716|SUPERIORITY||Mean Difference (Final Values)|-0.08||||0.444|TWO_SIDED|95.0|-0.29|0.13|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment A (CHF 718 pMDI 100 µg TDD)"||0.13|-0.29|0.444
72514785|NCT03084718|144560716|SUPERIORITY||Mean Difference (Final Values)|0.11||||0.285|TWO_SIDED|95.0|-0.09|0.32|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment B (CHF 718 pMDI 400 µg TDD)"||0.32|-0.09|0.285
72514786|NCT03084718|144560716|SUPERIORITY||Mean Difference (Final Values)|-0.19||||0.06|TWO_SIDED|95.0|-0.4|0.01|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups were:~Treatment E (QVAR\^®, 320 µg TDD) vs Treatment D (Placebo)"||0.01|-0.40|0.060
72514787|NCT03084718|144560717|SUPERIORITY||Mean Difference (Final Values)|4.4||||0.115|TWO_SIDED|95.0|-1.1|10.0|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups were:~Treatment A (CHF 718 pMDI 100 µg TDD) vs Treatment D (Placebo)"||10.0|-1.1|0.115
72514788|NCT03084718|144560717|SUPERIORITY||Mean Difference (Final Values)|7.6||||0.008|TWO_SIDED|95.0|2.0|13.1|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups were:~Treatment B (CHF 718 pMDI 400 µg TDD) vs Treatment D (Placebo)"||13.1|2.0|0.008
72568050|NCT02037165|144667475|SUPERIORITY_OR_OTHER||adjusted mean difference|-0.67|STANDARD_ERROR_OF_MEAN|23.7285|||TWO_SIDED|95.0|-47.8|46.5|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 5:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||46.5|-47.8|
72568051|NCT02037165|144667475|SUPERIORITY_OR_OTHER||adjusted mean difference|-19.27|STANDARD_ERROR_OF_MEAN|27.6359|||TWO_SIDED|95.0|-74.3|35.7|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 6:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||35.7|-74.3|
72568052|NCT02037165|144667475|SUPERIORITY_OR_OTHER||adjusted mean difference|-25.23|STANDARD_ERROR_OF_MEAN|27.5524|||TWO_SIDED|95.0|-79.9|29.5|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 22:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||29.5|-79.9|
72624164|NCT03322566|144778551|SUPERIORITY||Difference in Percentages|-18.5||||0.9948|TWO_SIDED|95.0|-32.0|-4.3||One-sided p-value for testing. H0: difference in % = 0 versus H1: difference in % \> 0.|Stratified Miettinen and Nurminen method||Stratified by PD-L1 TPS ( \<50% vs. \>=50% ) and predominant tumor histology (squamous vs non-squamous);because of small sample size, the strata 'TPS \>= 50 percent Non-squamous' and 'TPS \>= 50% Squamous' were combined into one stratum.|||-4.3|-32.0|0.9948
72624165|NCT03322566|144778552|OTHER||Hazard Ratio (HR)|1.47||||0.94305|TWO_SIDED|95.0|0.91|2.36||One-sided p-value based on log-rank test stratified by TPS (\<50% vs \>=50%) and predominant histology (squamous vs non-squamous), because of small sample size, the strata 'TPS \>= 50% Non-squamous' and 'TPS \>= 50% Squamous' were combined into one.|Regression, Cox|Efron's method of tie handling||||2.36|0.91|0.94305
72624166|NCT03322566|144778553|OTHER||Hazard Ratio (HR)|1.9||||0.96272|TWO_SIDED|95.0|0.93|3.9||One-sided p-value based on log-rank test stratified by PD-L1 TPS (\<50% vs \>=50%) and predominant tumor histology (squamous vs non-squamous), because of small sample size, the strata (\<50% vs \>=50%) were combined into one stratum.|Regression, Cox|||||3.90|0.93|0.96272
72514789|NCT03084718|144560717|SUPERIORITY||Mean Difference (Final Values)|4.7||||0.099|TWO_SIDED|95.0|-0.9|10.2|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment D (Placebo)"||10.2|-0.9|0.099
72514790|NCT03084718|144560717|SUPERIORITY||Mean Difference (Final Values)|3.1||||0.275|TWO_SIDED|95.0|-2.5|8.8|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups were:~Treatment B (CHF 718 pMDI 400 µg TDD) vs Treatment A (CHF 718 pMDI 100 µg TDD)"||8.8|-2.5|0.275
72514791|NCT03084718|144560717|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.943|TWO_SIDED|95.0|-5.4|5.8|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment A (CHF 718 pMDI 100 µg TDD)"||5.8|-5.4|0.943
72514792|NCT03084718|144560717|SUPERIORITY||Mean Difference (Final Values)|-2.9||||0.308|TWO_SIDED|95.0|-8.6|2.7|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment B (CHF 718 pMDI 400 µg TDD)"||2.7|-8.6|0.308
72514793|NCT03084718|144560717|SUPERIORITY||Mean Difference (Final Values)|6.3||||0.024|TWO_SIDED|95.0|0.8|11.7|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups were:~Treatment E (QVAR\^®, 320 µg TDD) vs Treatment D (Placebo)"||11.7|0.8|0.024
72514794|NCT03084718|144560717|SUPERIORITY||Mean Difference (Final Values)|4.8||||0.129|TWO_SIDED|95.0|-1.4|11.0|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups were:~Treatment A (CHF 718 pMDI 100 µg TDD) vs Treatment D (Placebo)"||11.0|-1.4|0.129
72514795|NCT03084718|144560717|SUPERIORITY||Mean Difference (Final Values)|9.0||||0.004|TWO_SIDED|95.0|2.8|15.2|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups were:~Treatment B (CHF 718 pMDI 400 µg TDD) vs Treatment D (Placebo)"||15.2|2.8|0.004
72403402|NCT00481195|144312522|SUPERIORITY_OR_OTHER|||||||0.896||95.0||||P-value is from a Cochran-Mantel-Haenzel chi-square test adjusted for concurrent treatment for bipolar disorder|Cochran-Mantel-Haenszel|||||||0.8960
72403403|NCT00481195|144312523|SUPERIORITY_OR_OTHER|||||||0.2575||95.0||||P-value is from a Cochran-Mantel-Haenzel chi-square test adjusted for concurrent treatment for bipolar disorder|Cochran-Mantel-Haenszel|||||||0.2575
72403404|NCT00481195|144312524|SUPERIORITY_OR_OTHER|||||||0.3129||95.0||||P-value is from a Cochran-Mantel-Haenzel chi-square test adjusted for concurrent treatment for bipolar disorder|Cochran-Mantel-Haenszel|||||||0.3129
72403405|NCT00481195|144312525|SUPERIORITY_OR_OTHER|||||||0.1565||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group and the p-value for the treatment comparison is from an ANCOVA with treatment and concurrent treatment for bipolar disorder as factors, and the baseline value as covariate.||||0.1565
72403406|NCT00481195|144312526|SUPERIORITY_OR_OTHER|||||||0.6737||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group and the p-value for the treatment comparison is from an ANCOVA with treatment and concurrent treatment for bipolar disorder as factors, and the baseline value as covariate.||||0.6737
72403407|NCT00481195|144312527|SUPERIORITY_OR_OTHER|||||||0.2249||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group and the p-value for the treatment comparison is from an ANCOVA with treatment and concurrent treatment for bipolar disorder as factors, and the baseline value as covariate.||||0.2249
72403408|NCT00481195|144312528|SUPERIORITY_OR_OTHER|||||||0.0862||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group and the p-value for the treatment comparison is from an ANCOVA with treatment and concurrent treatment for bipolar disorder as factors, and the baseline value as covariate.||||0.0862
72403409|NCT00481195|144312529|SUPERIORITY_OR_OTHER|||||||0.9281||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group and the p-value for the treatment comparison is from an ANCOVA with treatment and concurrent treatment for bipolar disorder as factors, and the baseline value as covariate.||||0.9281
72403410|NCT00481195|144312530|SUPERIORITY_OR_OTHER|||||||0.4428||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group and the p-value for the treatment comparison is from an ANCOVA with treatment and concurrent treatment for bipolar disorder as factors, and the baseline value as covariate.||||0.4428
72514796|NCT03084718|144560717|SUPERIORITY||Mean Difference (Final Values)|5.9||||0.061|TWO_SIDED|95.0|-0.3|12.1|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment D (Placebo)"||12.1|-0.3|0.061
72514797|NCT03084718|144560717|SUPERIORITY||Mean Difference (Final Values)|4.3||||0.18|TWO_SIDED|95.0|-2.0|10.5|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups were:~Treatment B (CHF 718 pMDI 400 µg TDD) vs Treatment A (CHF 718 pMDI 100 µg TDD)"||10.5|-2.0|0.180
72514798|NCT03084718|144560717|SUPERIORITY||Mean Difference (Final Values)|1.1||||0.721|TWO_SIDED|95.0|-5.1|7.4|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment A (CHF 718 pMDI 100 µg TDD)"||7.4|-5.1|0.721
72514799|NCT03084718|144560717|SUPERIORITY||Mean Difference (Final Values)|-3.1||||0.328|TWO_SIDED|95.0|-9.4|3.1|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment B (CHF 718 pMDI 400 µg TDD)"||3.1|-9.4|0.328
72568053|NCT02037165|144667475|SUPERIORITY_OR_OTHER||adjusted mean difference|-17.19|STANDARD_ERROR_OF_MEAN|27.0135|||TWO_SIDED|95.0|-70.9|36.5|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 24:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||36.5|-70.9|
72403411|NCT00481195|144312531|SUPERIORITY_OR_OTHER|||||||0.0965||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group and the p-value for the treatment comparison is from an ANCOVA with treatment and concurrent treatment for bipolar disorder as factors, and the baseline value as covariate.||||0.0965
72403412|NCT00481195|144312532|SUPERIORITY_OR_OTHER|||||||0.5389||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group and the p-value for the treatment comparison is from an ANCOVA with treatment and concurrent treatment for bipolar disorder as factors, and the baseline value as covariate.||||0.5389
72403413|NCT00481195|144312533|SUPERIORITY_OR_OTHER|||||||0.0793||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group and the p-value for the treatment comparison is from an ANCOVA with treatment and concurrent treatment for bipolar disorder as factors, and the baseline value as covariate.||||0.0793
72403414|NCT00481195|144312534|SUPERIORITY_OR_OTHER|||||||0.3814||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group and the p-value for the treatment comparison is from an ANCOVA with treatment and concurrent treatment for bipolar disorder as factors, and the baseline value as covariate.||||0.3814
72403415|NCT00481195|144312535|SUPERIORITY_OR_OTHER|||||||0.8099||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group and the p-value for the treatment comparison is from an ANCOVA with treatment and concurrent treatment for bipolar disorder as factors, and the baseline value as covariate.||||0.8099
72403416|NCT00481195|144312536|SUPERIORITY_OR_OTHER|||||||0.0968||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group and the p-value for the treatment comparison is from an ANCOVA with treatment and concurrent treatment for bipolar disorder as factors, and the baseline value as covariate.||||0.0968
72403417|NCT00481195|144312537|SUPERIORITY_OR_OTHER|||||||0.1605||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group and the p-value for the treatment comparison is from an ANCOVA with treatment and concurrent treatment for bipolar disorder as factors, and the baseline value as covariate.||||0.1605
72403418|NCT00481195|144312538|SUPERIORITY_OR_OTHER|||||||0.1869||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group and the p-value for the treatment comparison is from an ANCOVA with treatment and concurrent treatment for bipolar disorder as factors, and the baseline value as covariate.||||0.1869
72403419|NCT00481195|144312539|SUPERIORITY_OR_OTHER|||||||0.0817||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group and the p-value for the treatment comparison is from an ANCOVA with treatment and concurrent treatment for bipolar disorder as factors, and the baseline value as covariate.||||0.0817
72514800|NCT03084718|144560717|SUPERIORITY||Mean Difference (Final Values)|7.1||||0.022|TWO_SIDED|95.0|1.0|13.2|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups were:~Treatment E (QVAR\^®, 320 µg TDD) vs Treatment D (Placebo)"||13.2|1.0|0.022
72514801|NCT03084718|144560717|SUPERIORITY||Mean Difference (Final Values)|4.6||||0.101|TWO_SIDED|95.0|-0.9|10.1|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups were:~Treatment A (CHF 718 pMDI 100 µg TDD) vs Treatment D (Placebo)"||10.1|-0.9|0.101
72514802|NCT03084718|144560717|SUPERIORITY||Mean Difference (Final Values)|8.3||||0.003|TWO_SIDED|95.0|2.8|13.9|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups were:~Treatment B (CHF 718 pMDI 400 µg TDD) vs Treatment D (Placebo)"||13.9|2.8|0.003
72514803|NCT03084718|144560717|SUPERIORITY||Mean Difference (Final Values)|5.3||||0.061|TWO_SIDED|95.0|-0.2|10.8|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment D (Placebo)"||10.8|-0.2|0.061
72514804|NCT03084718|144560717|SUPERIORITY||Mean Difference (Final Values)|3.7||||0.196|TWO_SIDED|95.0|-1.9|9.3|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups were:~Treatment B (CHF 718 pMDI 400 µg TDD) vs Treatment A (CHF 718 pMDI 100 µg TDD)"||9.3|-1.9|0.196
72514805|NCT03084718|144560717|SUPERIORITY||Mean Difference (Final Values)|0.7||||0.814|TWO_SIDED|95.0|-4.9|6.3|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment A (CHF 718 pMDI 100 µg TDD)"||6.3|-4.9|0.814
72514806|NCT03084718|144560717|SUPERIORITY||Mean Difference (Final Values)|-3.0||||0.291|TWO_SIDED|95.0|-8.6|2.6|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment B (CHF 718 pMDI 400 µg TDD)"||2.6|-8.6|0.291
72514807|NCT03084718|144560717|SUPERIORITY||Mean Difference (Final Values)|6.7||||0.016|TWO_SIDED|95.0|1.3|12.1|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups were:~Treatment E (QVAR\^®, 320 µg TDD) vs Treatment D (Placebo)"||12.1|1.3|0.016
72514808|NCT03084718|144560718|SUPERIORITY||Mean Difference (Final Values)|-0.1|||<|0.001|TWO_SIDED|95.0|-0.2|-0.1|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups were:~Treatment A (CHF 718 pMDI 100 µg TDD) vs Treatment D (Placebo)"||-0.1|-0.2|< 0.001
72514809|NCT03084718|144560718|SUPERIORITY||Mean Difference (Final Values)|-0.1|||<|0.001|TWO_SIDED|95.0|-0.2|-0.1|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups were:~Treatment B (CHF 718 pMDI 400 µg TDD) vs Treatment D (Placebo)"||-0.1|-0.2|< 0.001
72568054|NCT02037165|144667475|SUPERIORITY_OR_OTHER||adjusted mean difference|-39.62|STANDARD_ERROR_OF_MEAN|29.3023|||TWO_SIDED|95.0|-97.7|18.5|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 0:30h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||18.5|-97.7|
72568055|NCT02037165|144667475|SUPERIORITY_OR_OTHER||adjusted mean difference|-37.06|STANDARD_ERROR_OF_MEAN|29.5797|||TWO_SIDED|95.0|-95.7|21.6|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 1:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||21.6|-95.7|
72624167|NCT02314923|144778561|OTHER|||||||0.951|||||||ANOVA|||||||0.951
72624168|NCT02314923|144778561|OTHER|||||||0.458|||||||ANOVA|||||||0.458
72624169|NCT02314923|144778561|OTHER|||||||0.071|||||||ANOVA|||||||0.071
72403420|NCT00481195|144312540|SUPERIORITY_OR_OTHER|||||||0.3712||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group and the p-value for the treatment comparison is from an ANCOVA with treatment and concurrent treatment for bipolar disorder as factors, and the baseline value as covariate.||||0.3712
72514810|NCT03084718|144560718|SUPERIORITY||Mean Difference (Final Values)|-0.1|||<|0.001|TWO_SIDED|95.0|-0.2|-0.1|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment D (Placebo)"||-0.1|-0.2|< 0.001
72514811|NCT03084718|144560718|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.913|TWO_SIDED|95.0|-0.1|0.1|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups were:~Treatment B (CHF 718 pMDI 400 µg TDD) vs Treatment A (CHF 718 pMDI 100 µg TDD)"||0.1|-0.1|0.913
72514812|NCT03084718|144560718|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.871|TWO_SIDED|95.0|-0.1|0.1|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment A (CHF 718 pMDI 100 µg TDD)"||0.1|-0.1|0.871
72514813|NCT03084718|144560718|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.958|TWO_SIDED|95.0|-0.1|0.1|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment B (CHF 718 pMDI 400 µg TDD)"||0.1|-0.1|0.958
72514814|NCT03084718|144560718|SUPERIORITY||Mean Difference (Final Values)|-0.1|||<|0.001|TWO_SIDED|95.0|-0.2|-0.1|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups were:~Treatment E (QVAR\^®, 320 µg TDD) vs Treatment D (Placebo)"||-0.1|-0.2|< 0.001
72514815|NCT03084718|144560718|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.01|TWO_SIDED|95.0|-0.2|0.0|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups were:~Treatment A (CHF 718 pMDI 100 µg TDD) vs Treatment D (Placebo)"||-0.0|-0.2|0.010
72624170|NCT02314923|144778561|OTHER||||||<|0.001|||||||ANOVA|||||||<0.001
72624171|NCT02314923|144778561|OTHER|||||||0.029|||||||ANOVA|||||||0.029
72624172|NCT02314923|144778561|OTHER|||||||0.325|||||||ANOVA|||||||0.325
72624173|NCT02314923|144778561|OTHER|||||||0.003|||||||ANOVA|||||||0.003
72487904|NCT01360554|144504485|SUPERIORITY_OR_OTHER||Repeated measures mixed-effects model.|2.6381||||||95.0|0.172|5.104|||||This analysis represents the mean difference between the dacomitinib arm (Arm A) and the erlotinib arm (Arm B).|Analysis presented for Trouble Swallowing as Assessed by the EORTC-QLQ-LC13. Estimated change from baseline was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-LC13 subscale baseline score (intercept and time from first dose are included as random effects). Confidence intervals provided were not adjusted for multiplicity.||5.104|0.172|
72487905|NCT01360554|144504485|SUPERIORITY_OR_OTHER||Repeated measures mixed-effects model.|-4.2504||||||95.0|-7.178|-1.322|||||This analysis represents the mean difference between the dacomitinib arm (Arm A) and the erlotinib arm (Arm B).|Analysis presented for Coughing as Assessed by the EORTC-QLQ-LC13. Estimated change from baseline was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-LC13 subscale baseline score (intercept and time from first dose are included as random effects). Confidence intervals provided were not adjusted for multiplicity.||-1.322|-7.178|
72487906|NCT01360554|144504485|SUPERIORITY_OR_OTHER||Repeated measures mixed-effects model|-1.0764||||||95.0|-3.997|1.845|||||This analysis represents the mean difference between the dacomitinib arm (Arm A) and the erlotinib arm (Arm B).|Analysis presented for Haemoptysis as Assessed by the EORTC-QLQ-LC13. Estimated change from baseline was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-LC13 subscale baseline score (intercept and time from first dose are included as random effects). Confidence intervals provided were not adjusted for multiplicity.||1.845|-3.997|
72487907|NCT01360554|144504485|SUPERIORITY_OR_OTHER||Repeated measures mixed-effects model.|9.3545||||||95.0|6.211|12.497|||||This analysis represents the mean difference between the dacomitinib arm (Arm A) and the erlotinib arm (Arm B).|Analysis presented for Sore Mouth as Assessed by the EORTC-QLQ-LC13. Estimated change from baseline was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-LC13 subscale baseline score (intercept and time from first dose are included as random effects). Confidence intervals provided were not adjusted for multiplicity.||12.497|6.211|
72487908|NCT01360554|144504485|SUPERIORITY_OR_OTHER||Repeated measures mixed-effects model.|-1.1762||||||95.0|-3.56|1.208|||||This analysis represents the mean difference between the dacomitinib arm (Arm A) and the erlotinib arm (Arm B).|Analysis presented for Shortness of Breath as Assessed by the EORTC-QLQ-LC13. Estimated change from baseline was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-LC13 subscale baseline score (intercept and time from first dose are included as random effects). Confidence intervals provided were not adjusted for multiplicity.||1.208|-3.560|
72487909|NCT01360554|144504485|SUPERIORITY_OR_OTHER||Repeated measures mixed-effects model.|-0.6378||||||95.0|-3.684|2.408|||||This analysis represents the mean difference between the dacomitinib arm (Arm A) and the erlotinib arm (Arm B).|Analysis presented for Peripheral Neuropathy as Assessed by the EORTC-QLQ-LC13. Estimated change from baseline was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-LC13 subscale baseline score (intercept and time from first dose are included as random effects). Confidence intervals provided were not adjusted for multiplicity.||2.408|-3.684|
72487910|NCT01360554|144504485|SUPERIORITY_OR_OTHER||Repeated measures mixed-effects model.|-1.3637||||||95.0|-4.546|1.819|||||This analysis represents the mean difference between the dacomitinib arm (Arm A) and the erlotinib arm (Arm B).|Analysis presented for Alopecia as Assessed by the EORTC-QLQ-LC13. Estimated change from baseline was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-LC13 subscale baseline score (intercept and time from first dose are included as random effects). Confidence intervals provided were not adjusted for multiplicity.||1.819|-4.546|
72487911|NCT01360554|144504485|SUPERIORITY_OR_OTHER||Repeated measures mixed-effects model.|-1.2163||||||95.0|-3.885|1.452|||||This analysis represents the mean difference between the dacomitinib arm (Arm A) and the erlotinib arm (Arm B).|Analysis presented for Pain in Chest as Assessed by the EORTC-QLQ-LC13. Estimated change from baseline was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-LC13 subscale baseline score (intercept and time from first dose are included as random effects). Confidence intervals provided were not adjusted for multiplicity.||1.452|-3.885|
72514816|NCT03084718|144560718|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.011|TWO_SIDED|95.0|-0.2|0.0|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups were:~Treatment B (CHF 718 pMDI 400 µg TDD) vs Treatment D (Placebo)"||-0.0|-0.2|0.011
72487912|NCT01360554|144504485|SUPERIORITY_OR_OTHER||Repeated measures mixed-effects model.|-1.1475||||||95.0|-3.902|1.607|||||This analysis represents the mean difference between the dacomitinib arm (Arm A) and the erlotinib arm (Arm B).|Analysis presented for Pain in Arm or Shoulder as Assessed by the EORTC-QLQ-LC13. Estimated change from baseline was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-LC13 subscale baseline score (intercept and time from first dose are included as random effects). Confidence intervals provided were not adjusted for multiplicity.||1.607|-3.902|
72487913|NCT01360554|144504485|SUPERIORITY_OR_OTHER||Repeated measures mixed-effects model.|-1.0687||||||95.0|-4.488|2.351|||||This analysis represents the mean difference between the dacomitinib arm (Arm A) and the erlotinib arm (Arm B).|Analysis presented for Pain Other Parts as Assessed by the EORTC-QLQ-LC13. Estimated change from baseline was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-LC13 subscale baseline score (intercept and time from first dose are included as random effects). Confidence intervals provided were not adjusted for multiplicity.||2.351|-4.488|
72514817|NCT03084718|144560718|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.002|TWO_SIDED|95.0|-0.2|0.0|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment D (Placebo)"||-0.0|-0.2|0.002
72514818|NCT03084718|144560718|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.996|TWO_SIDED|95.0|-0.1|0.1|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups were:~Treatment B (CHF 718 pMDI 400 µg TDD) vs Treatment A (CHF 718 pMDI 100 µg TDD)"||0.1|-0.1|0.996
72514819|NCT03084718|144560718|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.632|TWO_SIDED|95.0|-0.1|0.1|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment A (CHF 718 pMDI 100 µg TDD)"||0.1|-0.1|0.632
72568056|NCT02037165|144667475|SUPERIORITY_OR_OTHER||adjusted mean difference|-52.45|STANDARD_ERROR_OF_MEAN|24.8429|||TWO_SIDED|95.0|-101.8|-3.1|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 2:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||-3.1|-101.8|
72568057|NCT02037165|144667475|SUPERIORITY_OR_OTHER||adjusted mean difference|-59.87|STANDARD_ERROR_OF_MEAN|23.0541|||TWO_SIDED|95.0|-105.6|-14.1|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 3:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||-14.1|-105.6|
72568058|NCT02037165|144667475|SUPERIORITY_OR_OTHER||adjusted mean difference|-39.96|STANDARD_ERROR_OF_MEAN|22.9336|||TWO_SIDED|95.0|-85.5|5.5|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 4:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||5.5|-85.5|
72568059|NCT02037165|144667475|SUPERIORITY_OR_OTHER||adjusted mean difference|-38.99|STANDARD_ERROR_OF_MEAN|23.4683|||TWO_SIDED|95.0|-85.6|7.6|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 5:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||7.6|-85.6|
72514820|NCT03084718|144560718|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.63|TWO_SIDED|95.0|-0.1|0.1|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment B (CHF 718 pMDI 400 µg TDD)"||0.1|-0.1|0.630
72514821|NCT03084718|144560718|SUPERIORITY||Mean Difference (Final Values)|-0.1|||<|0.001|TWO_SIDED|95.0|-0.2|-0.1|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups were:~Treatment E (QVAR\^®, 320 µg TDD) vs Treatment D (Placebo)"||-0.1|-0.2|< 0.001
72514822|NCT03084718|144560718|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.002|TWO_SIDED|95.0|-0.2|0.0|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups were:~Treatment A (CHF 718 pMDI 100 µg TDD) vs Treatment D (Placebo)"||-0.0|-0.2|0.002
72514823|NCT03084718|144560718|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.001|TWO_SIDED|95.0|-0.2|0.0|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups were:~Treatment B (CHF 718 pMDI 400 µg TDD) vs Treatment D (Placebo)"||-0.0|-0.2|0.001
72514824|NCT03084718|144560718|SUPERIORITY||Mean Difference (Final Values)|-0.1|||<|0.001|TWO_SIDED|95.0|-0.2|-0.1|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment D (Placebo)"||-0.1|-0.2|< 0.001
72568060|NCT02037165|144667475|SUPERIORITY_OR_OTHER||adjusted mean difference|-63.69|STANDARD_ERROR_OF_MEAN|27.3484|||TWO_SIDED|95.0|-118.1|-9.3|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 6:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||-9.3|-118.1|
72568061|NCT02037165|144667475|SUPERIORITY_OR_OTHER||adjusted mean difference|-61.36|STANDARD_ERROR_OF_MEAN|27.2866|||TWO_SIDED|95.0|-115.6|-7.2|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 22:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||-7.2|-115.6|
72624174|NCT02314923|144778561|OTHER||||||<|0.001|||||||ANOVA|||||||<0.001
72624175|NCT02314923|144778561|OTHER|||||||0.427|||||||ANOVA|||||||0.427
72624176|NCT02314923|144778561|OTHER|||||||0.065|||||||ANOVA|||||||0.065
72624177|NCT02314923|144778561|OTHER||||||<|0.001|||||||ANOVA|||||||<0.001
72624178|NCT02314923|144778561|OTHER|||||||0.027|||||||ANOVA|||||||0.027
72624179|NCT02314923|144778561|OTHER|||||||0.303|||||||ANOVA|||||||0.303
72514825|NCT03084718|144560718|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.96|TWO_SIDED|95.0|-0.1|0.1|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups were:~Treatment B (CHF 718 pMDI 400 µg TDD) vs Treatment A (CHF 718 pMDI 100 µg TDD)"||0.1|-0.1|0.960
72514826|NCT03084718|144560718|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.725|TWO_SIDED|95.0|-0.1|0.1|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment A (CHF 718 pMDI 100 µg TDD)"||0.1|-0.1|0.725
72514827|NCT03084718|144560718|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.764|TWO_SIDED|95.0|-0.1|0.1|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment B (CHF 718 pMDI 400 µg TDD)"||0.1|-0.1|0.764
72487914|NCT01360554|144504485|SUPERIORITY_OR_OTHER||Repeated measures mixed-effects model.|0.0322||||||95.0|-4.847|4.911|||||This analysis represents the mean difference between the dacomitinib arm (Arm A) and the erlotinib arm (Arm B).|Analysis presented for Any Med for Pain as Assessed by the EORTC-QLQ-LC13. Estimated change from baseline was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-LC13 subscale baseline score (intercept and time from first dose are included as random effects). Confidence intervals provided were not adjusted for multiplicity.||4.911|-4.847|
72514828|NCT03084718|144560718|SUPERIORITY||Mean Difference (Final Values)|-0.1|||<|0.001|TWO_SIDED|95.0|-0.2|-0.1|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups were:~Treatment E (QVAR\^®, 320 µg TDD) vs Treatment D (Placebo)"||-0.1|-0.2|< 0.001
72514829|NCT03084718|144560719|SUPERIORITY||Mean Difference (Final Values)|2.9||||0.316|TWO_SIDED|95.0|-2.8|8.7|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups were:~Treatment A (CHF 718 pMDI 100 µg TDD) vs Treatment D (Placebo)"||8.7|-2.8|0.316
72514830|NCT03084718|144560719|SUPERIORITY||Mean Difference (Final Values)|4.9||||0.097|TWO_SIDED|95.0|-0.9|10.7|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups were:~Treatment B (CHF 718 pMDI 400 µg TDD) vs Treatment D (Placebo)"||10.7|-0.9|0.097
72487915|NCT01360554|144504486|SUPERIORITY_OR_OTHER||Repeated measures mixed-effects model.|-0.3886||||||95.0|-2.413|1.636|||||This analysis represents the mean difference between the dacomitinib arm (Arm A) and the erlotinib arm (Arm B).|Analysis presented for EQ-5D VAS. Mean difference was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-C30 subscale baseline score (intercept and time from first dose are included as random effects). Confidence intervals provided were not adjusted for multiplicity.||1.636|-2.413|
72487916|NCT02113436|144504499|SUPERIORITY_OR_OTHER||Difference in Least square means|-0.97||||0.206|TWO_SIDED|95.0|-2.47|0.54|||ANCOVA|||||0.54|-2.47|0.206
72487917|NCT02113436|144504500|SUPERIORITY_OR_OTHER||Difference in Least sqaure means|-0.49||||0.235|TWO_SIDED|95.0|-1.29|0.32|||ANCOVA|||||0.32|-1.29|0.235
72487918|NCT02113436|144504501|SUPERIORITY_OR_OTHER||Difference in Least-Sqaure means|-0.48||||0.236|TWO_SIDED|95.0|-1.27|0.31|||ANCOVA|||||0.31|-1.27|0.236
72487919|NCT02113436|144504502|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.47|||||TWO_SIDED|95.0|0.14|1.6||||||||1.60|0.14|
72487920|NCT02113436|144504503|SUPERIORITY_OR_OTHER||Difference in Least-Square Means|0.7||||0.041|TWO_SIDED|95.0|0.0|1.4|||ANCOVA|||||1.4|0.0|0.041
72624180|NCT02314923|144778561|OTHER|||||||0.003|||||||ANOVA|||||||0.003
72403421|NCT00481195|144312541|SUPERIORITY_OR_OTHER|||||||0.5427||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group and the p-value for the treatment comparison is from an ANCOVA with treatment and concurrent treatment for bipolar disorder as factors, and the baseline value as covariate.||||0.5427
72487921|NCT02113436|144504504|SUPERIORITY_OR_OTHER||Difference in Least Square Means|-0.06||||0.335|TWO_SIDED|95.0|-0.2|0.07|||ANCOVA|||||0.07|-0.20|0.335
72487922|NCT02113436|144504505|SUPERIORITY_OR_OTHER||Difference in Least Square Means|2.6||||0.389|TWO_SIDED|95.0|-3.3|8.6|||ANCOVA|||||8.6|-3.3|0.389
72487923|NCT01961349|144504518|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA|||||||<0.001
72487924|NCT01961349|144504518|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA|||||||<0.001
72487925|NCT01961349|144504519|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Fisher Exact|||||||<0.001
72487926|NCT01961349|144504519|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Fisher Exact|||||||<0.001
72514831|NCT03084718|144560719|SUPERIORITY||Mean Difference (Final Values)|4.4||||0.128|TWO_SIDED|95.0|-1.3|10.2|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment D (Placebo)"||10.2|-1.3|0.128
72487927|NCT01299376|144504520|SUPERIORITY_OR_OTHER||Difference in Least-squares Means|-5.9|||<|0.001|TWO_SIDED|95.0|-7.5|-4.2|||Contrained Longitudinal Data Analysis|Model including treatment, time and the interaction of time by treatment with a restriction of the same baseline mean across treatment groups.||||-4.2|-7.5|<0.001
72487928|NCT01299376|144504531|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-10.3|||<|0.001|TWO_SIDED|95.0|-12.8|-7.7||Model including treatment, time and the interaction of time by treatment with a restriction of the same baseline mean across treatment groups.|Constrained Longitudinal Data Analysis|||||-7.7|-12.8|<0.001
72487929|NCT04315181|144504532|SUPERIORITY||||||<|0.0001||||||Statistical significance is 2-sided and accepted at a P value of ≤ 0.05.|Mixed Models Analysis|F=6.89, df=8, 72||Peak scores were calculated for individual participants within each dose condition and analyzed in a one-factor model (drug condition) with a compound symmetry covariance structure.||||<0.0001
72487930|NCT04315181|144504533|SUPERIORITY||||||<|0.0001||||||Statistical significance is 2-sided and accepted at a P value of ≤ 0.05.|Mixed Models Analysis|F=5.51, df=8, 72||Peak scores were calculated for individual participants within each dose condition and analyzed in a one-factor model (drug condition) with a compound symmetry covariance structure.||||<0.0001
72487931|NCT04315181|144504534|SUPERIORITY|||||||0.138||||||Statistical significance is 2-sided and accepted at a P value of ≤ 0.05.|Mixed Models Analysis|F=1.61, df=8, 72||Trough scores were calculated for individual participants within each dose condition and analyzed in a one-factor model (drug condition) with a compound symmetry covariance structure.||||0.138
72487932|NCT04315181|144504535|SUPERIORITY||||||<|0.0001||||||Statistical significance is 2-sided and accepted at a P value of ≤ 0.05.|Mixed Models Analysis|F=8.15, df=8, 72||Peak scores were calculated for individual participants within each dose condition and analyzed in a one-factor model (drug condition) with a compound symmetry covariance structure.||||<0.0001
72487933|NCT04315181|144504536|SUPERIORITY|||||||0.0002||||||Statistical significance is 2-sided and accepted at a P value of ≤ 0.05.|Mixed Models Analysis|F=4.58, df=8, 72||Trough scores were calculated for individual participants within each dose condition and analyzed in a one-factor model (drug condition) with a compound symmetry covariance structure.||||0.0002
72514832|NCT03084718|144560719|SUPERIORITY||Mean Difference (Final Values)|2.0||||0.511|TWO_SIDED|95.0|-3.9|7.8|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups were:~Treatment B (CHF 718 pMDI 400 µg TDD) vs Treatment A (CHF 718 pMDI 100 µg TDD)"||7.8|-3.9|0.511
72624181|NCT02314923|144778561|OTHER||||||<|0.001|||||||ANOVA|||||||<0.001
72624182|NCT02314923|144778561|OTHER|||||||0.286|||||||ANOVA|||||||0.286
72624183|NCT02314923|144778561|OTHER||||||<|0.001|||||||ANOVA|||||||<0.001
72624184|NCT02314923|144778561|OTHER|||||||0.094|||||||ANOVA|||||||0.094
72624185|NCT02314923|144778561|OTHER|||||||0.757|||||||ANOVA|||||||0.757
72487934|NCT05879107|144504540|NON_INFERIORITY|NI was to be demonstrated if the upper limit of the 2-sided 95% confidence interval (CI) of the GMT ratio (as measured by the OP assay) between the Control group (at Day 31) versus Co-administration group (at Day 31) was \<=2.|GMT ratio|1.48|||||TWO_SIDED|95.0|1.22|1.81|||||The analysis of covariance (ANCOVA) model, for logarithm-transformed titers, included the treatment group and age category at vaccination as fixed effects and the pre-dose log-10 titer as covariate.|Strep pneumoniae - serotype 1||1.81|1.22|
72514833|NCT03084718|144560719|SUPERIORITY||Mean Difference (Final Values)|1.5||||0.61|TWO_SIDED|95.0|-4.3|7.3|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment A (CHF 718 pMDI 100 µg TDD)"||7.3|-4.3|0.610
72514834|NCT03084718|144560719|SUPERIORITY||Mean Difference (Final Values)|-0.4||||0.882|TWO_SIDED|95.0|-6.3|5.4|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment B (CHF 718 pMDI 400 µg TDD)"||5.4|-6.3|0.882
72514835|NCT03084718|144560719|SUPERIORITY||Mean Difference (Final Values)|7.2||||0.013|TWO_SIDED|95.0|1.5|12.9|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups were:~Treatment E (QVAR\^®, 320 µg TDD) vs Treatment D (Placebo)"||12.9|1.5|0.013
72514836|NCT03084718|144560719|SUPERIORITY||Mean Difference (Final Values)|4.7||||0.219|TWO_SIDED|95.0|-2.8|12.2|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups were:~Treatment A (CHF 718 pMDI 100 µg TDD) vs Treatment D (Placebo)"||12.2|-2.8|0.219
72514837|NCT03084718|144560719|SUPERIORITY||Mean Difference (Final Values)|5.3||||0.166|TWO_SIDED|95.0|-2.2|12.8|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups were:~Treatment B (CHF 718 pMDI 400 µg TDD) vs Treatment D (Placebo)"||12.8|-2.2|0.166
72568062|NCT02037165|144667475|SUPERIORITY_OR_OTHER||adjusted mean difference|-49.4|STANDARD_ERROR_OF_MEAN|26.7541|||TWO_SIDED|95.0|-102.6|3.8|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 24:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||3.8|-102.6|
72568063|NCT01568866|144667484|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.533|||<|0.0001|TWO_SIDED|95.0|0.437|0.651|||Stratified Log Rank|Log rank test stratified by the randomization stratification factors.|The hazard ratio (carfilzomib/bortezomib) was estimated using a Cox proportional hazards model stratified by prior proteasome inhibitor treatment, lines of prior treatment, ISS stage, and choice of route of bortezomib administration.|"The PFS interim analysis was to be performed using a group sequential monitoring plan.~The monitoring plan included an O'Brien-Fleming type of efficacy stopping boundary constructed using the Lan-DeMets alpha spending function to ensure a 1-sided Type I error rate ≤ 0.025."||0.651|0.437|< 0.0001
72568064|NCT01568866|144667485|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.791||||0.01|TWO_SIDED|95.0|0.648|0.964||The multiplicity in testing secondary endpoints was adjusted per group using the sequential Holm procedure to preserve the family-wise error rate at 0.025.|Stratified Log Rank|Log rank test stratified by the randomization stratification factors.|The hazard ratio (carfilzomib/bortezomib) was estimated using a Cox proportional hazards model stratified by prior proteasome inhibitor treatment, lines of prior treatment, ISS stage, and choice of route of bortezomib administration.|The second interim analysis of overall survival was to be conducted after 394 events had been reached. A one-sided significance level was determined using the O'Brien-Fleming-type α spending function based on the actual number of events (α=0.0123).||0.964|0.648|0.0100
72577099|NCT00580788|144680816|NON_INFERIORITY_OR_EQUIVALENCE|The study was designed as a standard dose-escalation study, dose-finding pilot study. The primary outcome measures were safety (hypercalcemia, hypophosphatemia and symptoms/hemodynamic measurements). A modified Fibronacci dose-escalation scheme was employed.|||||>|0.05|TWO_SIDED|||||The reported p-value corresponds to change over time from baseline for all Arms/groups|Mixed Models Analysis|The level of statistical significance was set at .05 (two-tailed)||||||>.05
72487935|NCT05879107|144504540|NON_INFERIORITY|NI was to be demonstrated if the upper limit of the 2-sided 95% CI of the GMT ratio (as measured by the OP assay) between the Control group (at Day 31) versus Co-administration group (at Day 31) was \<=2.|GMT ratio|1.31|||||TWO_SIDED|95.0|1.12|1.54|||||The ANCOVA model, for logarithm-transformed titers, included the treatment group and age category at vaccination as fixed effects and the pre-dose log-10 titer as covariate.|Strep pneumoniae - serotype 3||1.54|1.12|
72514838|NCT03084718|144560719|SUPERIORITY||Mean Difference (Final Values)|5.5||||0.151|TWO_SIDED|95.0|-2.0|12.9|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment D (Placebo)"||12.9|-2.0|0.151
72514839|NCT03084718|144560719|SUPERIORITY||Mean Difference (Final Values)|0.6||||0.871|TWO_SIDED|95.0|-6.9|8.2|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups were:~Treatment B (CHF 718 pMDI 400 µg TDD) vs Treatment A (CHF 718 pMDI 100 µg TDD)"||8.2|-6.9|0.871
72514840|NCT03084718|144560719|SUPERIORITY||Mean Difference (Final Values)|0.8||||0.837|TWO_SIDED|95.0|-6.8|8.3|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment A (CHF 718 pMDI 100 µg TDD)"||8.3|-6.8|0.837
72514841|NCT03084718|144560719|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.966|TWO_SIDED|95.0|-7.4|7.7|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment B (CHF 718 pMDI 400 µg TDD)"||7.7|-7.4|0.966
72514842|NCT03084718|144560719|SUPERIORITY||Mean Difference (Final Values)|9.5||||0.012|TWO_SIDED|95.0|2.1|16.9|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups were:~Treatment E (QVAR\^®, 320 µg TDD) vs Treatment D (Placebo)"||16.9|2.1|0.012
72514843|NCT03084718|144560719|SUPERIORITY||Mean Difference (Final Values)|3.8||||0.233|TWO_SIDED|95.0|-2.5|10.1|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups were:~Treatment A (CHF 718 pMDI 100 µg TDD) vs Treatment D (Placebo)"||10.1|-2.5|0.233
72514844|NCT03084718|144560719|SUPERIORITY||Mean Difference (Final Values)|5.1||||0.113|TWO_SIDED|95.0|-1.2|11.4|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups were:~Treatment B (CHF 718 pMDI 400 µg TDD) vs Treatment D (Placebo)"||11.4|-1.2|0.113
72514845|NCT03084718|144560719|SUPERIORITY||Mean Difference (Final Values)|5.0||||0.12|TWO_SIDED|95.0|-1.3|11.2|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment D (Placebo)"||11.2|-1.3|0.120
72514846|NCT03084718|144560719|SUPERIORITY||Mean Difference (Final Values)|1.3||||0.691|TWO_SIDED|95.0|-5.1|7.6|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups were:~Treatment B (CHF 718 pMDI 400 µg TDD) vs Treatment A (CHF 718 pMDI 100 µg TDD)"||7.6|-5.1|0.691
72514847|NCT03084718|144560719|SUPERIORITY||Mean Difference (Final Values)|1.2||||0.722|TWO_SIDED|95.0|-5.2|7.5|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment A (CHF 718 pMDI 100 µg TDD)"||7.5|-5.2|0.722
72514848|NCT03084718|144560719|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.966|TWO_SIDED|95.0|-6.5|6.2|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment B (CHF 718 pMDI 400 µg TDD)"||6.2|-6.5|0.966
72568065|NCT01568866|144667486|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.032|||<|0.0001|TWO_SIDED|95.0|1.519|2.718||The multiplicity in testing secondary endpoints was adjusted per group using the sequential Holm procedure to preserve the family-wise error rate at 0.025.|Stratified Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by the randomization stratification factors.|The odds ratio (carfilzomib/bortezomib) was calculated using the Cochran-Mantel-Haenszel method stratified by prior proteasome inhibitor treatment, lines of prior treatment, ISS stage, and choice of route of bortezomib administration.|||2.718|1.519|< 0.0001
72568066|NCT01568866|144667488|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.137|||<|0.0001|TWO_SIDED|95.0|0.089|0.21||The multiplicity in testing secondary endpoints was adjusted per group using the sequential Holm procedure to preserve the family-wise error rate at 0.025.|Cochran-Mantel-Haenszel||The odds ratio (carfilzomib/bortezomib) was estimated using the unconditional Cochran-Mantel-Haenszel method.|||0.210|0.089|<0.0001
72568067|NCT01698775|144667492|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.33||||0.035|TWO_SIDED|95.0|-0.63|-0.02|||ANCOVA|||||-0.02|-0.63|0.035
72568068|NCT01698775|144667493|SUPERIORITY_OR_OTHER||Difference in percentages|-3.8|||||TWO_SIDED|95.0|-16.3|8.8|||||Based on Miettinen \& Nurminen method stratified by renal status stratum.|||8.8|-16.3|
72403422|NCT00481195|144312542|SUPERIORITY_OR_OTHER|||||||0.3463||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group and the p-value for the treatment comparison is from an ANCOVA with treatment and concurrent treatment for bipolar disorder as factors, and the baseline value as covariate.||||0.3463
72514849|NCT03084718|144560719|SUPERIORITY||Mean Difference (Final Values)|8.3||||0.008|TWO_SIDED|95.0|2.2|14.5|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups were:~Treatment E (QVAR\^®, 320 µg TDD) vs Treatment D (Placebo)"||14.5|2.2|0.008
72514850|NCT03084718|144560720|SUPERIORITY||Mean Difference (Final Values)|2.3||||0.426|TWO_SIDED|95.0|-3.4|7.9|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups were:~Treatment A (CHF 718 pMDI 100 µg TDD) vs Treatment D (Placebo)"||7.9|-3.4|0.426
72568069|NCT01698775|144667494|SUPERIORITY_OR_OTHER||Difference in percentages|1.9|||||TWO_SIDED|95.0|-2.6|7.2|||||Based on Miettinen \& Nurminen method stratified by renal status stratum.|||7.2|-2.6|
72514851|NCT03084718|144560720|SUPERIORITY||Mean Difference (Final Values)|5.6||||0.055|TWO_SIDED|95.0|-0.1|11.2|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups were:~Treatment B (CHF 718 pMDI 400 µg TDD) vs Treatment D (Placebo)"||11.2|-0.1|0.055
72514852|NCT03084718|144560720|SUPERIORITY||Mean Difference (Final Values)|5.4||||0.059|TWO_SIDED|95.0|-0.2|11.1|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment D (Placebo)"||11.1|-0.2|0.059
72568070|NCT01698775|144667495|SUPERIORITY_OR_OTHER||Difference in percentage|-0.9|||||TWO_SIDED|95.0|-12.2|10.3|||||Based on Miettinen \& Nurminen method stratified by renal status stratum.|||10.3|-12.2|
72568071|NCT01698775|144667496|SUPERIORITY_OR_OTHER||Difference in percentage|2.8|||||TWO_SIDED|95.0|-3.6|9.8||||||||9.8|-3.6|
72568072|NCT01698775|144667497|SUPERIORITY_OR_OTHER||Difference in least squares means|-3.9||||0.54|TWO_SIDED|95.0|-16.5|8.7|||ANCOVA|||||8.7|-16.5|0.540
72568073|NCT01698775|144667500|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.4||||0.72|TWO_SIDED|95.0|-2.7|1.9|||cLDA|||||1.9|-2.7|0.720
72514853|NCT03084718|144560720|SUPERIORITY||Mean Difference (Final Values)|3.3||||0.263|TWO_SIDED|95.0|-2.5|9.0|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups were:~Treatment B (CHF 718 pMDI 400 µg TDD) vs Treatment A (CHF 718 pMDI 100 µg TDD)"||9.0|-2.5|0.263
72568074|NCT01244061|144667502|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|7.08|||<|0.0001|TWO_SIDED|95.0|4.34|11.55||The statistical significance was declared for each hypothesis firstly for CAR Weeks 9-12, and then secondly for CAR Weeks 9-52 until a p-value \> 0.05 was obtained, at which point the hypothesis would be declared to be not statistically significant.|Regression, Logistic|The analysis model included main effect of treatment and pooled center.||The study was conducted on a sample size to achieve at least 90% power for the treatment comparison in the primary efficacy endpoint assuming an odds ratio of 3.36 with a placebo abstinence rate of 12% and varenicline abstinence rate of 31%. The intent of the primary efficacy analysis was to evaluate the hypothesis that varenicline is superior to placebo for smoking cessation after 12 weeks of treatment.||11.55|4.34|<0.0001
72577100|NCT00580788|144680817|NON_INFERIORITY_OR_EQUIVALENCE|The study was designed as a standard dose-escalation study, dose-finding pilot study. The primary outcome measures were safety (hypercalcemia, hypophosphatemia and symptoms/hemodynamic measurements). A modified Fibronacci dose-escalation scheme was employed.|||||<|0.008|TWO_SIDED|||||The reported p-value corresponds to the % increase compared to baseline in all Arms/groups on Days 2-8.|Mixed Models Analysis|The level of statistical significance was set at .05 (two-tailed)||||||<.008
72624186|NCT02314923|144778561|OTHER|||||||0.022|||||||ANOVA|||||||0.022
72624187|NCT02314923|144778561|OTHER|||||||0.001|||||||ANOVA|||||||0.001
72624188|NCT02314923|144778561|OTHER||||||<|0.001|||||||ANOVA|||||||<0.001
72624189|NCT02314923|144778561|OTHER|||||||0.348|||||||ANOVA|||||||0.348
72624190|NCT02314923|144778561|OTHER|||||||0.508|||||||ANOVA|||||||0.508
72624191|NCT02314923|144778561|OTHER|||||||0.191|||||||ANOVA|||||||0.191
72403423|NCT00481195|144312543|SUPERIORITY_OR_OTHER|||||||0.273||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group and the p-value for the treatment comparison is from an ANCOVA with treatment and concurrent treatment for bipolar disorder as factors, and the baseline value as covariate.||||0.2730
72514854|NCT03084718|144560720|SUPERIORITY||Mean Difference (Final Values)|3.1||||0.28|TWO_SIDED|95.0|-2.6|8.8|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment A (CHF 718 pMDI 100 µg TDD)"||8.8|-2.6|0.280
72514855|NCT03084718|144560720|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.965|TWO_SIDED|95.0|-5.9|5.6|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment B (CHF 718 pMDI 400 µg TDD)"||5.6|-5.9|0.965
72514856|NCT03084718|144560720|SUPERIORITY||Mean Difference (Final Values)|7.8||||0.007|TWO_SIDED|95.0|2.2|13.3|||Mixed Models Analysis|||"Inter-visit period 1~Treatment E (QVAR\^®, 320 µg TDD) vs Treatment D (Placebo)"||13.3|2.2|0.007
72514857|NCT03084718|144560720|SUPERIORITY||Mean Difference (Final Values)|3.8||||0.308|TWO_SIDED|95.0|-3.5|11.2|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups were:~Treatment A (CHF 718 pMDI 100 µg TDD) vs Treatment D (Placebo)"||11.2|-3.5|0.308
72514858|NCT03084718|144560720|SUPERIORITY||Mean Difference (Final Values)|5.8||||0.124|TWO_SIDED|95.0|-1.6|13.2|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups were:~Treatment B (CHF 718 pMDI 400 µg TDD) vs Treatment D (Placebo)"||13.2|-1.6|0.124
72514859|NCT03084718|144560720|SUPERIORITY||Mean Difference (Final Values)|7.0||||0.063|TWO_SIDED|95.0|-0.4|14.3|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment D (Placebo)"||14.3|-0.4|0.063
72514860|NCT03084718|144560720|SUPERIORITY||Mean Difference (Final Values)|2.0||||0.602|TWO_SIDED|95.0|-5.5|9.4|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups were:~Treatment B (CHF 718 pMDI 400 µg TDD) vs Treatment A (CHF 718 pMDI 100 µg TDD)"||9.4|-5.5|0.602
72514861|NCT03084718|144560720|SUPERIORITY||Mean Difference (Final Values)|3.2||||0.402|TWO_SIDED|95.0|-4.3|10.6|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment A (CHF 718 pMDI 100 µg TDD)"||10.6|-4.3|0.402
72514862|NCT03084718|144560720|SUPERIORITY||Mean Difference (Final Values)|1.2||||0.753|TWO_SIDED|95.0|-6.3|8.6|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment B (CHF 718 pMDI 400 µg TDD)"||8.6|-6.3|0.753
72514863|NCT03084718|144560720|SUPERIORITY||Mean Difference (Final Values)|10.2||||0.006|TWO_SIDED|95.0|2.9|17.4|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups were:~Treatment E (QVAR\^®, 320 µg TDD) vs Treatment D (Placebo)"||17.4|2.9|0.006
72514864|NCT03084718|144560720|SUPERIORITY||Mean Difference (Final Values)|3.1||||0.331|TWO_SIDED|95.0|-3.1|9.2|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups were:~Treatment A (CHF 718 pMDI 100 µg TDD) vs Treatment D (Placebo)"||9.2|-3.1|0.331
72514865|NCT03084718|144560720|SUPERIORITY||Mean Difference (Final Values)|5.7||||0.073|TWO_SIDED|95.0|-0.5|11.9|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups were:~Treatment B (CHF 718 pMDI 400 µg TDD) vs Treatment D (Placebo)"||11.9|-0.5|0.073
72577101|NCT00580788|144680817|NON_INFERIORITY_OR_EQUIVALENCE|The study was designed as a standard dose-escalation study, dose-finding pilot study. The primary outcome measures were safety (hypercalcemia, hypophosphatemia and symptoms/hemodynamic measurements). A modified Fibronacci dose-escalation scheme was employed.|||||>|0.05|TWO_SIDED|||||The reported p-value corresponds the the % change from baseline at follow-up in all Arms/groups|Mixed Models Analysis|The level of statistical significance was set at .05 (two-tailed)||||||>0.05
72514866|NCT03084718|144560720|SUPERIORITY||Mean Difference (Final Values)|6.2||||0.048|TWO_SIDED|95.0|0.1|12.4|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment D (Placebo)"||12.4|0.1|0.048
72514867|NCT03084718|144560720|SUPERIORITY||Mean Difference (Final Values)|2.6||||0.41|TWO_SIDED|95.0|-3.6|8.9|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups were:~Treatment B (CHF 718 pMDI 400 µg TDD) vs Treatment A (CHF 718 pMDI 100 µg TDD)"||8.9|-3.6|0.410
72514868|NCT03084718|144560720|SUPERIORITY||Mean Difference (Final Values)|3.2||||0.32|TWO_SIDED|95.0|-3.1|9.4|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment A (CHF 718 pMDI 100 µg TDD)"||9.4|-3.1|0.320
72514869|NCT03084718|144560720|SUPERIORITY||Mean Difference (Final Values)|0.5||||0.867|TWO_SIDED|95.0|-5.7|6.8|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment B (CHF 718 pMDI 400 µg TDD)"||6.8|-5.7|0.867
72514870|NCT03084718|144560720|SUPERIORITY||Mean Difference (Final Values)|9.0||||0.004|TWO_SIDED|95.0|2.9|15.0|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups were:~Treatment E (QVAR\^®, 320 µg TDD) vs Treatment D (Placebo)"||15.0|2.9|0.004
72514871|NCT03084718|144560721|SUPERIORITY||Mean Difference (Final Values)|4.0||||0.26|TWO_SIDED|95.0|-3.2|11.9|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups were:~Treatment A (CHF 718 pMDI 100 µg TDD) vs Treatment D (Placebo)"||11.9|-3.2|0.260
72514872|NCT03084718|144560721|SUPERIORITY||Mean Difference (Final Values)|3.0||||0.387|TWO_SIDED|95.0|-4.2|10.9|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups were:~Treatment B (CHF 718 pMDI 400 µg TDD) vs Treatment D (Placebo)"||10.9|-4.2|0.387
72514873|NCT03084718|144560721|SUPERIORITY||Mean Difference (Final Values)|2.0||||0.574|TWO_SIDED|95.0|-5.4|9.7|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment D (Placebo)"||9.7|-5.4|0.574
72624192|NCT02314923|144778561|OTHER|||||||0.024|||||||ANOVA|||||||0.024
72624193|NCT02314923|144778561|OTHER|||||||0.169|||||||ANOVA|||||||0.169
72624194|NCT02314923|144778561|OTHER|||||||0.961|||||||ANOVA|||||||0.961
72624195|NCT02314923|144778561|OTHER|||||||0.454|||||||ANOVA|||||||0.454
72624196|NCT02314923|144778561|OTHER||||||<|0.001|||||||ANOVA|||||||<0.001
72624197|NCT02314923|144778561|OTHER|||||||0.068|||||||ANOVA|||||||0.068
72403424|NCT00481195|144312544|SUPERIORITY_OR_OTHER|||||||0.7791||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group and the p-value for the treatment comparison is from an ANCOVA with treatment and concurrent treatment for bipolar disorder as factors, and the baseline value as covariate.||||0.7791
72487936|NCT05879107|144504540|NON_INFERIORITY|NI was to be demonstrated if the upper limit of the 2-sided 95% CI of the GMT ratio (as measured by the OP assay) between the Control group (at Day 31) versus Co-administration group (at Day 31) was \<=2.|GMT ratio|1.34|||||TWO_SIDED|95.0|1.13|1.58|||||The ANCOVA model, for logarithm-transformed titers, included the treatment group and age category at vaccination as fixed effects and the pre-dose log-10 titer as covariate.|Strep pneumoniae - serotype 4||1.58|1.13|
72487937|NCT05879107|144504540|NON_INFERIORITY|NI was to be demonstrated if the upper limit of the 2-sided 95% CI of the GMT ratio (as measured by the OP assay) between the Control group (at Day 31) versus Co-administration group (at Day 31) was \<=2.|GMT ratio|1.36|||||TWO_SIDED|95.0|1.08|1.71|||||The ANCOVA model, for logarithm-transformed titers, included the treatment group and age category at vaccination as fixed effects and the pre-dose log-10 titer as covariate.|Strep pneumoniae - serotype 5||1.71|1.08|
72514874|NCT03084718|144560721|SUPERIORITY||Mean Difference (Final Values)|-1.0||||0.799|TWO_SIDED|95.0|-8.6|6.7|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups were:~Treatment B (CHF 718 pMDI 400 µg TDD) vs Treatment A (CHF 718 pMDI 100 µg TDD)"||6.7|-8.6|0.799
72514875|NCT03084718|144560721|SUPERIORITY||Mean Difference (Final Values)|-2.0||||0.577|TWO_SIDED|95.0|-9.8|5.5|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment A (CHF 718 pMDI 100 µg TDD)"||5.5|-9.8|0.577
72514876|NCT03084718|144560721|SUPERIORITY||Mean Difference (Final Values)|-1.0||||0.764|TWO_SIDED|95.0|-8.8|6.5|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment B (CHF 718 pMDI 400 µg TDD)"||6.5|-8.8|0.764
72403425|NCT00481195|144312545|SUPERIORITY_OR_OTHER|||||||0.9007||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group and the p-value for the treatment comparison is from an ANCOVA with treatment and concurrent treatment for bipolar disorder as factors, and the baseline value as covariate.||||0.9007
72487938|NCT05879107|144504540|NON_INFERIORITY|NI was to be demonstrated if the upper limit of the 2-sided 95% CI of the GMT ratio (as measured by the OP assay) between the Control group (at Day 31) versus Co-administration group (at Day 31) was \<=2.|GMT ratio|1.37|||||TWO_SIDED|95.0|1.12|1.69|||||The ANCOVA model, for logarithm-transformed titers, included the treatment group and age category at vaccination as fixed effects and the pre-dose log-10 titer as covariate.|Strep pneumoniae - serotype 6A||1.69|1.12|
72514877|NCT03084718|144560721|SUPERIORITY||Mean Difference (Final Values)|6.0||||0.097|TWO_SIDED|95.0|-1.1|13.8|||Mixed Models Analysis|||"Inter-visit period 1~Treatment E (QVAR\^®, 320 µg TDD) vs Treatment D (Placebo)"||13.8|-1.1|0.097
72514878|NCT03084718|144560721|SUPERIORITY||Mean Difference (Final Values)|-1.0||||0.908|TWO_SIDED|95.0|-9.9|8.8|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups were:~Treatment A (CHF 718 pMDI 100 µg TDD) vs Treatment D (Placebo)"||8.8|-9.9|0.908
72514879|NCT03084718|144560721|SUPERIORITY||Mean Difference (Final Values)|7.0||||0.135|TWO_SIDED|95.0|-2.2|16.5|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups were:~Treatment B (CHF 718 pMDI 400 µg TDD) vs Treatment D (Placebo)"||16.5|-2.2|0.135
72514880|NCT03084718|144560721|SUPERIORITY||Mean Difference (Final Values)|-1.0||||0.786|TWO_SIDED|95.0|-10.7|8.1|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment D (Placebo"||8.1|-10.7|0.786
72568075|NCT01244061|144667503|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|9.0|||<|0.0001|TWO_SIDED|95.0|3.97|20.41||Statistical significance was declared for each hypothesis in the order above until a p-value \>0.05 was obtained, at which point the hypothesis was declared to be not statistically significant.|Regression, Logistic|The analysis model included main effect of treatment and pooled center.||The sample size was sufficient to achieve 80% power for the treatment comparison in the key secondary end point for an odds ratio of 2.55 with a placebo abstinence rate of 6% and varenicline abstinence rate of 14%. The intent of the key secondary efficacy analysis was to evaluate the hypothesis that varenicline is superior to placebo for smoking cessation from Week 9 to the end of non-treatment follow up period at Week 52.||20.41|3.97|<0.0001
72568076|NCT01244061|144667504|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.83|||<|0.0001|TWO_SIDED|95.0|3.25|10.44||The statistical test was two-sided and at a 0.05 level of significance. No adjustment was made for the analysis of multiple secondary endpoints.|Regression, Logistic|The analysis model included main effect of treatment and pooled center.||||10.44|3.25|<0.0001
72568077|NCT01244061|144667505|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|7.85|||<|0.0001|TWO_SIDED|95.0|4.92|12.51||The statistical test was two-sided and at a 0.05 level of significance. No adjustment was made for the analysis of multiple secondary endpoints.|Regression, Logistic|The analysis model included main effect of treatment and pooled center.||Week 12 assessment||12.51|4.92|<0.0001
72568078|NCT01244061|144667505|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.94|||<|0.0001|TWO_SIDED|95.0|1.86|4.64||The statistical test was two-sided and at a 0.05 level of significance. No adjustment was made for the analysis of multiple secondary endpoints.|Regression, Logistic|The analysis model included main effect of treatment and pooled center.||Week 24 assessment||4.64|1.86|<0.0001
72568079|NCT01244061|144667505|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.06|||<|0.0001|TWO_SIDED|95.0|1.88|4.97||The statistical test was two-sided and at a 0.05 level of significance. No adjustment was made for the analysis of multiple secondary endpoints.|Regression, Logistic|The analysis model included main effect of treatment and pooled center.||Week 52 assessment||4.97|1.88|<0.0001
72568080|NCT04932941|144667508|SUPERIORITY||Common risk difference|-0.276||||0.962|TWO_SIDED|95.0|-11.634|11.081|||Mantel Haenszel||Strata-adjusted Mantel Haenszel (MH) method for difference in proportions controlling for stratification factors (COVID-19 severity: moderate, severe, and age group: less than or equal to 65 years, greater than 65 years).|||11.081|-11.634|0.962
72568081|NCT01929031|144667533|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|41.738|STANDARD_ERROR_OF_MEAN|4.058|<|0.0001|TWO_SIDED|95.0|33.767|49.708|||ANCOVA|The statistical model included baseline PI (VRS), and treatment.|Ibuprofen/Caffeine vs. Placebo|||49.708|33.767|<0.0001
72568082|NCT01929031|144667533|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|36.467|STANDARD_ERROR_OF_MEAN|4.058|<|0.0001|TWO_SIDED|95.0|28.497|44.437|||ANCOVA|The statistical model included baseline PI (VRS), and treatment.|Ibuprofen/Caffeine vs. Caffeine|||44.437|28.497|<0.0001
72568083|NCT01929031|144667533|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.126|STANDARD_ERROR_OF_MEAN|2.868|<|0.0001|TWO_SIDED|95.0|6.493|17.759|||ANCOVA|The statistical model included baseline PI (VRS), and treatment.|Ibuprofen/Caffeine vs. Ibuprofen|||17.759|6.493|<0.0001
72403426|NCT00481195|144312546|SUPERIORITY_OR_OTHER|||||||0.6431||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group and the p-value for the treatment comparison is from an ANCOVA with treatment and concurrent treatment for bipolar disorder as factors, and the baseline value as covariate.||||0.6431
72403427|NCT00481195|144312547|SUPERIORITY_OR_OTHER|||||||0.6631||95.0|||||Cochran-Mantel-Haenszel|Adjusted for concurrent treatment for bipolar disorder.||||||0.6631
72568084|NCT01929031|144667534|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.525|STANDARD_ERROR_OF_MEAN|0.808|<|0.0001|TWO_SIDED|95.0|6.937|10.113|||ANCOVA|The statistical model included baseline PI (VRS), and treatment.|Ibuprofen/Caffeine vs. Placebo|||10.113|6.937|<0.0001
72568085|NCT01929031|144667534|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.972|STANDARD_ERROR_OF_MEAN|0.808|<|0.0001|TWO_SIDED|95.0|6.384|9.559|||ANCOVA|The statistical model included baseline PI (VRS), and treatment.|Ibuprofen/Caffeine vs. Caffeine|||9.559|6.384|<0.0001
72568086|NCT01929031|144667534|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.594|STANDARD_ERROR_OF_MEAN|0.571|<|0.0001|TWO_SIDED|95.0|2.472|4.716|||ANCOVA|The statistical model included baseline PI (VRS), and treatment.|Ibuprofen/Caffeine vs. Ibuprofen|||4.716|2.472|<0.0001
72568087|NCT01929031|144667535|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Log Rank|Log rank test stratified for baseline pain intensity as measured on the 4-point VRS.||Ibuprofen/Caffeine vs. Placebo||||<0.0001
72568088|NCT01929031|144667535|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Log Rank|Log rank test stratified for baseline pain intensity as measured on the 4-point VRS.||Ibuprofen/Caffeine vs. Caffeine||||<0.0001
72624198|NCT02314923|144778561|OTHER|||||||0.007|||||||ANOVA|||||||0.007
72568089|NCT01929031|144667535|SUPERIORITY_OR_OTHER|||||||0.2389|TWO_SIDED||||||Log Rank|Log rank test stratified for baseline pain intensity as measured on the 4-point VRS.||Ibuprofen/Caffeine vs. Ibuprofen||||0.2389
72403428|NCT00481195|144312548|SUPERIORITY_OR_OTHER|||||||0.9768||95.0|||||Cochran-Mantel-Haenszel|Adjusted for concurrent treatment for bipolar disorder||||||0.9768
72403429|NCT00481195|144312549|SUPERIORITY_OR_OTHER|||||||0.9873||95.0|||||Cochran-Mantel-Haenszel|Adjusted for concurrent treatment fro bipolar disorder||||||0.9873
72403430|NCT00481195|144312550|SUPERIORITY_OR_OTHER|||||||0.4567||95.0|||||Cochran-Mantel-Haenszel|Adjusted for concurrent treatment for bipolar disorder||||||0.4567
72568090|NCT01929031|144667536|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Log Rank|Log rank test stratified for baseline pain intensity as measured on the 4-point VRS.||Ibuprofen/Caffeine vs. Placebo||||<0.0001
72568091|NCT01929031|144667536|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Log Rank|Log rank test stratified for baseline pain intensity as measured on the 4-point VRS.||Ibuprofen/Caffeine vs. Caffeine||||<0.0001
72568092|NCT01929031|144667536|SUPERIORITY_OR_OTHER|||||||0.0001|TWO_SIDED||||||Log Rank|Log rank test stratified for baseline pain intensity as measured on the 4-point VRS.||Ibuprofen/Caffeine vs. Ibuprofen||||0.0001
72568093|NCT00321594|144667539|OTHER||Maximum Tolerated Dose|1400.0|||||TWO_SIDED||||||||MTD was not reached and the maximum dose of 1400 mg/m2 is used in Phase II portion|MTD is defined as the dose below which \>=2 of 3 or \>= 2 of 6 patients experience DLT||||
72624199|NCT02314923|144778561|OTHER||||||<|0.001|||||||ANOVA|||||||<0.001
72624200|NCT02314923|144778561|OTHER|||||||0.37|||||||ANOVA|||||||0.370
72624201|NCT02314923|144778561|OTHER||||||<|0.001|||||||ANOVA|||||||<0.001
72403431|NCT00481195|144312551|SUPERIORITY_OR_OTHER|||||||0.6475||95.0|||||Cochran-Mantel-Haenszel|Adjusted for concurrent treatment for bipolar disorder||||||0.6475
72403432|NCT00481195|144312552|SUPERIORITY_OR_OTHER|||||||0.5066||95.0|||||Cochran-Mantel-Haenszel|Adjusted for concurrent treatment for bipolar disorder||||||0.5066
72403433|NCT00481195|144312553|SUPERIORITY_OR_OTHER|||||||0.4438||95.0|||||Cochran-Mantel-Haenszel|Adjusted for concurrent treatment for bipolar disorder||||||0.4438
72403434|NCT03343483|144312554|SUPERIORITY||Mean Difference (Final Values)|-0.138|STANDARD_ERROR_OF_MEAN|1.06||0.896|TWO_SIDED|95.0|-2.21|1.93|||Mixed Models Analysis|||||1.93|-2.21|.896
72403435|NCT03343483|144312555|SUPERIORITY||Mean Difference (Final Values)|0.44||||0.8|TWO_SIDED||||||ANOVA|||||||0.80
72403436|NCT03343483|144312556|SUPERIORITY||Mean Difference (Final Values)|0.59||||0.33|TWO_SIDED||||||Mixed Models Analysis|||||||0.33
72403437|NCT03343483|144312557|SUPERIORITY||Mean Difference (Final Values)|0.08||||0.58|TWO_SIDED||||||Mixed Models Analysis|||||||0.58
72403438|NCT03343483|144312558|SUPERIORITY||Mean Difference (Final Values)|0.8||||0.73|TWO_SIDED||||||Mixed Models Analysis|||||||0.73
72403439|NCT03343483|144312559|SUPERIORITY||Mean Difference (Final Values)|0.08||||0.57|TWO_SIDED||||||Mixed Models Analysis|||||||0.57
72403440|NCT05045144|144312586|OTHER|The lot-to-lot consistency is demonstrated only if two-sided 95% confidence intervals (CI) for the 3 pair-wise geometric mean ratios of RSV MAT IgG ELISA concentration falls within 0.67 and 1.5.|GMC Ratio|1.02|||||TWO_SIDED|95.0|0.92|1.13|||GMC ratio|||To demonstrate lot-to-lot consistency of the immune responses of Lot 1 and Lot 2 of the RSV MAT vaccine, as measured by ELISA in terms of IgG GMCs at Day 31.||1.13|0.92|
72403441|NCT05045144|144312586|OTHER|The lot-to-lot consistency is demonstrated only if two-sided 95% confidence intervals (CI) for the 3 pair-wise geometric mean ratios of RSV MAT IgG ELISA concentration falls within 0.67 and 1.5.|GMC ratio|0.95|||||TWO_SIDED|95.0|0.85|1.05|||GMC ratio|||To demonstrate lot-to-lot consistency of the immune responses of Lot 1 and Lot 3 of the RSV MAT vaccine, as measured by ELISA in terms of IgG GMCs at Day 31.||1.05|0.85|
72514881|NCT03084718|144560721|SUPERIORITY||Mean Difference (Final Values)|8.0||||0.109|TWO_SIDED|95.0|-1.7|17.1|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups were:~Treatment B (CHF 718 pMDI 400 µg TDD) vs Treatment A (CHF 718 pMDI 100 µg TDD)"||17.1|-1.7|0.109
72403442|NCT05045144|144312586|OTHER|The lot-to-lot consistency is demonstrated only if two-sided 95% confidence intervals (CI) for the 3 pair-wise geometric mean ratios of RSV MAT IgG ELISA concentration falls within 0.67 and 1.5.|GMC ratio|0.93|||||TWO_SIDED|95.0|0.83|1.03|||GMC ratio|||To demonstrate lot-to-lot consistency of the immune responses of Lot 2 and Lot 3 of the RSV MAT vaccine, as measured by ELISA in terms of IgG GMCs at Day 31.||1.03|0.83|
72403443|NCT05045144|144312587|NON_INFERIORITY|The non-inferiority of Flu D-QIV vaccine is demonstrated for the A/Tasmania/503/2020 (H3N2) IVR-221 strain, if the lower limit (LL) of the 95% CI on the GMT ratio (RSV MAT + Flu D-QIV vaccine divided by Flu D-QIV vaccine) is greater than 0.67 at Day 31 post vaccination.|GMC ratio|0.72|||||TWO_SIDED|95.0|0.63|0.82|||GMC ratio|||To demonstrate the immunological non-inferiority of the Flu D-QIV vaccine when co-administered with RSV MAT vaccine compared to Flu D-QIV vaccine given alone as measured by the ratio of HI GMTs of Flu D-QIV antibody titers against A/Tasmania/503/2020 (H3N2) IVR-221 strain at 30 days post administration (Day 31).||0.82|0.63|
72403444|NCT05045144|144312587|NON_INFERIORITY|The non-inferiority of Flu D-QIV vaccine is demonstrated for B/Washington/02/2019 strain, if the lower limit (LL) of the 95% CI on the GMT ratio (RSV MAT + Flu D-QIV vaccine divided by Flu D-QIV vaccine) is greater than 0.67 at Day 31 post vaccination.|GMC ratio|0.93|||||TWO_SIDED|95.0|0.79|1.1|||GMC ratio|||To demonstrate the immunological non-inferiority of the Flu D-QIV vaccine when co-administered with RSV MAT vaccine compared to Flu D-QIV vaccine given alone as measured by the ratio of HI GMTs of Flu D-QIV antibody titers against B/Washington/02/2019 strain at 30 days post administration (Day 31).||1.10|0.79|
72514882|NCT03084718|144560721|SUPERIORITY||Mean Difference (Final Values)|-1.0||||0.876|TWO_SIDED|95.0|-10.1|8.7|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment A (CHF 718 pMDI 100 µg TDD)"||8.7|-10.1|0.876
72514883|NCT03084718|144560721|SUPERIORITY||Mean Difference (Final Values)|-8.0||||0.08|TWO_SIDED|95.0|-17.9|1.0|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment B (CHF 718 pMDI 400 µg TDD)"||1.0|-17.9|0.080
72514884|NCT03084718|144560721|SUPERIORITY||Mean Difference (Final Values)|6.0||||0.202|TWO_SIDED|95.0|-3.2|15.3|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups were:~Treatment E (QVAR\^®, 320 µg TDD) vs Treatment D (Placebo)"||15.3|-3.2|0.202
72403445|NCT05045144|144312587|NON_INFERIORITY|The non-inferiority of Flu D-QIV vaccine is demonstrated for B/Phuket/3073/2013 strain, if the lower limit (LL) of the 95% CI on the GMT ratio (RSV MAT + Flu D-QIV vaccine divided by Flu D-QIV vaccine) is greater than 0.67 at Day 31 post vaccination.|GMC ratio|0.8|||||TWO_SIDED|95.0|0.69|0.93|||GMC ratio|||To demonstrate the immunological non-inferiority of the Flu D-QIV vaccine when co-administered with RSV MAT vaccine compared to Flu D-QIV vaccine given alone as measured by the ratio of HI GMTs of Flu D-QIV antibody titers against B/Phuket/3073/2013 strain at 30 days post administration (Day 31).||0.93|0.69|
72403446|NCT05045144|144312588|NON_INFERIORITY|The non-inferiority of RSV MAT vaccine is demonstrated for RSV A neutralizing antibody titers, if the LL of the 95% CI on the GMT ratio (RSV MAT + Flu D-QIV vaccine divided by RSV MAT vaccine) is greater than 0.67 at Day 31 post vaccination.|GMC ratio|0.87|||||TWO_SIDED|95.0|0.78|0.97|||GMC ratio|||To demonstrate the immunological non-inferiority of the RSV MAT vaccine when co-administered with Flu D-QIV vaccine, compared to RSV MAT vaccine given alone as measured by the ratio of GMTs of RSV A neutralizing antibody titers at 30 days post administration (Day 31).||0.97|0.78|
72403447|NCT05045144|144312589|NON_INFERIORITY|The non-inferiority of Flu D-QIV vaccine is demonstrated with respect to the SCR difference for Flu D-QIV antibody titers against A/Tasmania/503/2020 (H3N2) IVR-221 strain, if the upper limit (UL) of the 95% CI on the SCR difference (Flu D-QIV vaccine minus RSV MAT + Flu D-QIV vaccine) is less than or equal to the pre-defined clinical limit of 10% at Day 31 post vaccination.|Difference of Proportion|3.44|||||TWO_SIDED|95.0|-3.44|10.29|||Miettinen and Nurminen|||To demonstrate the immunological non-inferiority of the Flu D-QIV vaccine when co-administered with RSV MAT vaccine compared to Flu D-QIV vaccine given alone as measured by the difference of proportion of participants achieving seroconversion for HI antibody titers against A/Tasmania/503/2020 (H3N2) IVR-221 strain at 30 days post administration (Day 31).||10.29|-3.44|
72403448|NCT05045144|144312589|NON_INFERIORITY|The non-inferiority of Flu D-QIV vaccine is demonstrated with respect to the SCR difference for Flu D-QIV antibody titers against B/Washington/02/2019 strain, if the upper limit (UL) of the 95% CI on the SCR difference (Flu D-QIV vaccine minus RSV MAT + Flu D-QIV vaccine) is less than or equal to the pre-defined clinical limit of 10% at Day 31 post vaccination.|Difference of Proportion|4.15|||||TWO_SIDED|95.0|-2.04|10.32|||Miettinen and Nurminen|||To demonstrate the immunological non-inferiority of the Flu D-QIV vaccine when co-administered with RSV MAT vaccine compared to Flu D-QIV vaccine given alone as measured by the difference of proportion of participants achieving seroconversion for HI antibody titers against B/Washington/02/2019 strain at 30 days post administration (Day 31).||10.32|-2.04|
72403449|NCT05045144|144312589|NON_INFERIORITY|The non-inferiority of Flu D-QIV vaccine is demonstrated with respect to the SCR difference for Flu D-QIV antibody titers against B/Phuket/3073/2013 strain, if the upper limit (UL) of the 95% CI on the SCR difference (Flu D-QIV vaccine minus RSV MAT + Flu D-QIV vaccine) is less than or equal to the pre-defined clinical limit of 10% at Day 31 post vaccination.|Difference of Proportion|4.08|||||TWO_SIDED|95.0|-2.46|10.58|||Miettinen and Nurminen|||To demonstrate the immunological non-inferiority of the Flu D-QIV vaccine when co-administered with RSV MAT vaccine compared to Flu D-QIV vaccine given alone as measured by the difference of proportion of participants achieving seroconversion for HI antibody titers against B/Phuket/3073/2013 strain at 30 days post administration (Day 31).||10.58|-2.46|
72487939|NCT05879107|144504540|NON_INFERIORITY|NI was to be demonstrated if the upper limit of the 2-sided 95% CI of the GMT ratio (as measured by the OP assay) between the Control group (at Day 31) versus Co-administration group (at Day 31) was \<=2.|GMT ratio|1.41|||||TWO_SIDED|95.0|1.17|1.7|||||The ANCOVA model, for logarithm-transformed titers, included the treatment group and age category at vaccination as fixed effects and the pre-dose log-10 titer as covariate.|Strep pneumoniae - serotype 6B||1.70|1.17|
72487940|NCT05879107|144504540|NON_INFERIORITY|NI was to be demonstrated if the upper limit of the 2-sided 95% CI of the GMT ratio (as measured by the OP assay) between the Control group (at Day 31) versus Co-administration group (at Day 31) was \<=2.|GMT ratio|1.34|||||TWO_SIDED|95.0|1.16|1.55|||||The ANCOVA model, for logarithm-transformed titers, included the treatment group and age category at vaccination as fixed effects and the pre-dose log-10 titer as covariate.|Strep pneumoniae - serotype 7F||1.55|1.16|
72487941|NCT05879107|144504540|NON_INFERIORITY|NI was to be demonstrated if the upper limit of the 2-sided 95% CI of the GMT ratio (as measured by the OP assay) between the Control group (at Day 31) versus Co-administration group (at Day 31) was \<=2.|GMT ratio|1.38|||||TWO_SIDED|95.0|1.17|1.64|||||The ANCOVA model, for logarithm-transformed titers, included the treatment group and age category at vaccination as fixed effects and the pre-dose log-10 titer as covariate.|Strep pneumoniae - serotype 8||1.64|1.17|
72487942|NCT05879107|144504540|NON_INFERIORITY|NI was to be demonstrated if the upper limit of the 2-sided 95% CI of the GMT ratio (as measured by the OP assay) between the Control group (at Day 31) versus Co-administration group (at Day 31) was \<=2.|GMT ratio|1.24|||||TWO_SIDED|95.0|1.05|1.47|||||The ANCOVA model, for logarithm-transformed titers, included the treatment group and age category at vaccination as fixed effects and the pre-dose log-10 titer as covariate.|Strep pneumoniae - serotype 9V||1.47|1.05|
72487943|NCT05879107|144504540|NON_INFERIORITY|NI was to be demonstrated if the upper limit of the 2-sided 95% CI of the GMT ratio (as measured by the OP assay) between the Control group (at Day 31) versus Co-administration group (at Day 31) was \<=2.|GMT ratio|1.22|||||TWO_SIDED|95.0|1.03|1.44|||||The ANCOVA model, for logarithm-transformed titers, included the treatment group and age category at vaccination as fixed effects and the pre-dose log-10 titer as covariate.|Strep pneumoniae - serotype 10A||1.44|1.03|
72487944|NCT05879107|144504540|NON_INFERIORITY|NI was to be demonstrated if the upper limit of the 2-sided 95% CI of the GMT ratio (as measured by the OP assay) between the Control group (at Day 31) versus Co-administration group (at Day 31) was \<=2.|GMT ratio|1.18|||||TWO_SIDED|95.0|0.98|1.42|||||The ANCOVA model, for logarithm-transformed titers, included the treatment group and age category at vaccination as fixed effects and the pre-dose log-10 titer as covariate.|Strep pneumoniae - serotype 11A||1.42|0.98|
72487945|NCT05879107|144504540|NON_INFERIORITY|NI was to be demonstrated if the upper limit of the 2-sided 95% CI of the GMT ratio (as measured by the OP assay) between the Control group (at Day 31) versus Co-administration group (at Day 31) was \<=2.|GMT ratio|1.2|||||TWO_SIDED|95.0|0.99|1.46|||||The ANCOVA model, for logarithm-transformed titers, included the treatment group and age category at vaccination as fixed effects and the pre-dose log-10 titer as covariate.|Strep pneumoniae - serotype 12F||1.46|0.99|
72487946|NCT05879107|144504540|NON_INFERIORITY|NI was to be demonstrated if the upper limit of the 2-sided 95% CI of the GMT ratio (as measured by the OP assay) between the Control group (at Day 31) versus Co-administration group (at Day 31) was \<=2.|GMT ratio|1.42|||||TWO_SIDED|95.0|1.21|1.67|||||The ANCOVA model, for logarithm-transformed titers, included the treatment group and age category at vaccination as fixed effects and the pre-dose log-10 titer as covariate.|Strep pneumoniae - serotype 14||1.67|1.21|
72487947|NCT05879107|144504540|NON_INFERIORITY|NI was to be demonstrated if the upper limit of the 2-sided 95% CI of the GMT ratio (as measured by the OP assay) between the Control group (at Day 31) versus Co-administration group (at Day 31) was \<=2.|GMT ratio|1.46|||||TWO_SIDED|95.0|1.22|1.76|||||The ANCOVA model, for logarithm-transformed titers, included the treatment group and age category at vaccination as fixed effects and the pre-dose log-10 titer as covariate.|Strep pneumoniae - serotype 15B||1.76|1.22|
72568094|NCT00375492|144667578|SUPERIORITY_OR_OTHER|||||||0.003||95.0|||||Mixed Model Repeated Measures|||||||0.0030
72568095|NCT00375492|144667579|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Mixed Model Repeated Measures|||||||<0.0001
72568096|NCT00375492|144667581|SUPERIORITY_OR_OTHER|||||||0.1985||95.0|||||Mixed Model Repeated Measures|||||||0.1985
72568097|NCT00375492|144667582|SUPERIORITY_OR_OTHER|||||||0.1827||95.0|||||ANCOVA|||||||0.1827
72568098|NCT00375492|144667583|SUPERIORITY_OR_OTHER|||||||0.1584||95.0|||||ANCOVA|||||||0.1584
72568099|NCT00375492|144667584|SUPERIORITY_OR_OTHER|||||||0.8279||95.0|||||ANCOVA|||||||0.8279
72568100|NCT00375492|144667585|SUPERIORITY_OR_OTHER|||||||0.8334||95.0|||||ANCOVA|||||||0.8334
72568101|NCT00375492|144667586|SUPERIORITY_OR_OTHER|||||||0.2881||95.0|||||ANCOVA|||||||0.2881
72403450|NCT01466387|144312597|NON_INFERIORITY_OR_EQUIVALENCE|GMC TF+YF+MenACWY-CRM/GMC TF+YF.|Ratio of GMC|1.14|||||TWO_SIDED|95.0|0.81|1.6||The testing was done by assessing the confidence interval of the ratio.|ANCOVA|The ANCOVA model included vaccine group and center as factors, age as covariate and was adjusted for baseline.||The primary criterion for immunogenicity (postvaccination, day 29) was that the lower limit of the two-sided 95% confidence interval around the observed ratio of geometric mean concentrations between one dose of typhoid Vi polysaccharide and yellow fever vaccines given concomitantly with MenACWY-CRM197 to typhoid Vi polysaccharide and yellow fever vaccines given alone was greater than 0.5.||1.6|0.81|
72514885|NCT03084718|144560721|SUPERIORITY||Mean Difference (Final Values)|2.0||||0.635|TWO_SIDED|95.0|-5.9|9.7|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups were:~Treatment A (CHF 718 pMDI 100 µg TDD) vs Treatment D (Placebo)"||9.7|-5.9|0.635
72514886|NCT03084718|144560721|SUPERIORITY||Mean Difference (Final Values)|5.0||||0.191|TWO_SIDED|95.0|-2.6|13.1|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups were:~Treatment B (CHF 718 pMDI 400 µg TDD) vs Treatment D (Placebo)"||13.1|-2.6|0.191
72514887|NCT03084718|144560721|SUPERIORITY||Mean Difference (Final Values)|0.4||||0.914|TWO_SIDED|95.0|-7.4|8.3|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment D (Placebo)"||8.3|-7.4|0.914
72514888|NCT03084718|144560721|SUPERIORITY||Mean Difference (Final Values)|3.0||||0.407|TWO_SIDED|95.0|-4.6|11.3|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups were:~Treatment B (CHF 718 pMDI 400 µg TDD) vs Treatment A (CHF 718 pMDI 100 µg TDD)"||11.3|-4.6|0.407
72568102|NCT00375492|144667587|SUPERIORITY_OR_OTHER|||||||0.0654||95.0|||||ANCOVA|||||||0.0654
72568103|NCT00375492|144667588|SUPERIORITY_OR_OTHER|||||||0.728||95.0|||||Cochran-Mantel-Haenszel|||||||0.728
72514889|NCT03084718|144560721|SUPERIORITY||Mean Difference (Final Values)|-1.0||||0.718|TWO_SIDED|95.0|-9.4|6.4|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment A (CHF 718 pMDI 100 µg TDD)"||6.4|-9.4|0.718
72514890|NCT03084718|144560721|SUPERIORITY||Mean Difference (Final Values)|-5.0||||0.235|TWO_SIDED|95.0|-12.7|3.1|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment B (CHF 718 pMDI 400 µg TDD)"||3.1|-12.7|0.235
72514891|NCT03084718|144560721|SUPERIORITY||Mean Difference (Final Values)|6.0||||0.118|TWO_SIDED|95.0|-1.6|13.9|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups were:~Treatment E (QVAR\^®, 320 µg TDD) vs Treatment D (Placebo)"||13.9|-1.6|0.118
72568104|NCT00375492|144667589|SUPERIORITY_OR_OTHER|||||||0.127||95.0|||||ANOVA|||||||0.127
72577102|NCT00580788|144680818|NON_INFERIORITY_OR_EQUIVALENCE|The study was designed as a standard dose-escalation study, dose-finding pilot study. The primary outcome measures were safety (hypercalcemia, hypophosphatemia and symptoms/hemodynamic measurements). A modified Fibronacci dose-escalation scheme was employed.|||||<|0.0001|TWO_SIDED|||||The reported p-value corresponds to % change (increase) from baseline in all Arms/groups at Days 2-8.|Mixed Models Analysis|The level of statistical significance was set at .05 (two-tailed)||||||<.0001
72403451|NCT01466387|144312598|NON_INFERIORITY_OR_EQUIVALENCE|GMT TF+YF+MenACWY/GMT TF+YF.|Ratio of GMT.|0.96|||||TWO_SIDED|95.0|0.65|1.41||The testing was done by assessing the confidence interval of the ratio.|ANCOVA|The ANCOVA model included vaccine group and center as factors, age as covariate and was adjusted for baseline.||The primary criterion for immunogenicity (postvaccination, day 29) was that the lower limit of the two sided 95% CI around the observed ratio of geometric mean titers between one dose of typhoid Vi polysaccharide and yellow fever vaccines given concomitantly with MenACWY-CRM197 to typhoid Vi polysaccharide and yellow fever vaccines given alone was greater than 0.5.||1.41|0.65|
72403452|NCT01466387|144312599|NON_INFERIORITY_OR_EQUIVALENCE|GMT JE + Rab + MenACWY-CRM/GMT JE + Rab.|Ratio of GMT|0.9|||||TWO_SIDED|95.0|0.7|1.16||The testing was done by assessing the confidence interval of the ratio.|ANCOVA|The ANCOVA model included vaccine group and centers as factors, age as covariate and was adjusted for baseline.||The primary criterion for immunogenicity (postvaccination, day 57) was that the lower limit of the two sided 95% CI around the observed ratio of geometric mean titers between the second dose of Japanese Encephalitis and third dose of rabies virus vaccines given concomitantly with MenACWY-CRM197 to Japanese Encephalitis and rabies virus vaccines given alone was greater than 0.5.||1.16|0.7|
72568105|NCT01232491|144667594|SUPERIORITY_OR_OTHER||Estimated treatment difference, LS Mean|0.49||||0.132||95.0|-0.15|1.13||If the p-value for the two-sided test was less than 5%, and D (the estimated treatment difference \[dietary intervention versus no dietary intervention\]) was less than 0 then superiority for dietary intervention was considered confirmed.|Regression, Linear|||Normal linear regression model with treatment, strata, use of insulin secretagogue at screening, sex and region as factors and age and weight at baseline as covariates. Superiority was considered confirmed if the upper bound of the two-sided 95% CI for the estimated treatment difference (dietary intervention versus no dietary intervention), which was calculated using the FAS, was below 0 kg.||1.13|-0.15|0.132
72568106|NCT01232491|144667595|SUPERIORITY_OR_OTHER||Estimated treatment difference, LS Mean|0.17||||0.137||95.0|-0.05|0.39|||Regression, Linear|||Normal linear regression model with treatment, use of insulin secretagogue at screening, sex and region as factors, and age and BMI at baseline as covariates.||0.39|-0.05|0.137
72568107|NCT01232491|144667596|SUPERIORITY_OR_OTHER||Estimated treatment difference, LS Mean|0.13||||0.053||95.0|0.0|0.26|||Regression, Linear|||Normal linear regression model with treatment, strata, use of insulin secretagogue at screening and region as factors and HbA1c at baseline as covariate.||0.26|-0.00|0.053
72568108|NCT01232491|144667597|SUPERIORITY_OR_OTHER||Estimated treatment difference, LS Mean|0.07||||0.674||95.0|-0.25|0.39|||Regression, Linear|||Normal linear regression model with treatment, strata, use of insulin secretagogue at screening and region as factors and FPG at baseline as covariate.||0.39|-0.25|0.674
72568109|NCT03573505|144667665|SUPERIORITY||Hazard Ratio (HR)|2.01||||0.112|TWO_SIDED|95.0|0.85|4.73|||Log Rank|||A cox proportional hazards model with terms for treatment (BG00011 vs. placebo) and randomization stratification factor is used. A stratified log-rank test is used to compare the 2 treatment groups using randomization stratus as the stratification factor. An HR (Hazard Ratio) \< 1 indicates lower risk of event for the BG00011 group where HR is based on Cox proportional hazard model with treatment (Placebo, BG00011) as the categorical covariate.||4.73|0.85|0.112
72568110|NCT04280705|144667683|SUPERIORITY||Cox Proportional Hazard|1.29|||<|0.001|TWO_SIDED|95.0|1.12|1.49|||Log Rank|||||1.49|1.12|<0.001
72568111|NCT04280705|144667707|SUPERIORITY|||||||0.058|||||||Barnard's Exact Test|||||||0.058
72568112|NCT04280705|144667708|SUPERIORITY|||||||0.01|||||||Barnard's Exact Test|||||||0.010
72568113|NCT04280705|144667720|SUPERIORITY||Cox Proportional Hazard|1.23||||0.002|TWO_SIDED|95.0|1.08|1.41|||Log Rank|||||1.41|1.08|0.002
72568114|NCT04280705|144667721|SUPERIORITY||Cox Proportional Hazard|1.29|||<|0.001|TWO_SIDED|95.0|1.12|1.48|||Log Rank|||||1.48|1.12|<0.001
72568115|NCT04280705|144667722|SUPERIORITY||Cox Proportional Hazard|1.27|||<|0.001|TWO_SIDED|95.0|1.1|1.46|||Log Rank|||||1.46|1.10|<0.001
72568116|NCT04280705|144667723|SUPERIORITY||Cox Proportional Hazard|1.07|||||TWO_SIDED|95.0|0.73|1.58||||||This analysis is for Asian participants||1.58|0.73|
72568117|NCT04280705|144667723|SUPERIORITY||Cox Proportional Hazard|1.25|||||TWO_SIDED|95.0|0.91|1.72||||||This analysis is for Black or African American participants||1.72|0.91|
72624202|NCT00725985|144778566|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.381|||<|0.0001|TWO_SIDED|95.0|0.248|0.584||The treatment effect was also assessed by hazard ratios using the Cox's proportional hazards model.|two-sided Wald test|||||0.584|0.248|<0.0001
72568118|NCT04280705|144667723|SUPERIORITY||Cox Proportional Hazard|1.29|||||TWO_SIDED|95.0|1.06|1.57||||||This analysis is for White participants||1.57|1.06|
72568119|NCT04280705|144667723|SUPERIORITY||Cox Proportional Hazard|1.68|||||TWO_SIDED|95.0|1.1|2.58||||||This analysis is for Race of Other participants||2.58|1.10|
72568120|NCT04280705|144667724|SUPERIORITY||Cox Proportional Hazard|1.31|||||TWO_SIDED|95.0|1.1|1.55||||||This analysis is for Not Hispanic or Latino participants||1.55|1.10|
72568121|NCT04280705|144667724|SUPERIORITY||Cox Proportional Hazard|1.28|||||TWO_SIDED|95.0|0.94|1.73||||||This analysis is for Hispanic or Latino participants||1.73|0.94|
72568122|NCT04280705|144667725|SUPERIORITY||Cox Proportional Hazard|1.3|||||TWO_SIDED|95.0|1.09|1.56||||||This analysis is for Male participants||1.56|1.09|
72568123|NCT04280705|144667725|SUPERIORITY||Cox Proportional Hazard|1.31|||||TWO_SIDED|95.0|1.03|1.66||||||This analysis is for Female participants||1.66|1.03|
72568124|NCT03222583|144667726|NON_INFERIORITY|The percentage of participants in Arm A with SVR12 was non-inferior to the historical SVR12 rate of 96% if the lower confidence bound (LCB) of the 2-sided 95% confidence interval (CI) for the percentage was \> 90%.|Percentage of Participants with SVR12|97.2|||||TWO_SIDED|95.0|95.5|98.9||||||In order to control the Type I error rate, a fixed sequence testing procedure was used for the 3 ranked primary efficacy endpoints. Only if success had been demonstrated for the first primary endpoint was testing to proceed to the second primary endpoint. Similarly, only if success had been demonstrated for the second primary endpoint was testing to proceed to the third primary endpoint.||98.9|95.5|
72624203|NCT00725985|144778566|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.327|||<|0.0001|TWO_SIDED|95.0|0.21|0.509||The treatment effect was also assessed by hazard ratios using the Cox's proportional hazards model.|two-sided Wald test|||||0.509|0.210|< 0.0001
72624204|NCT00725985|144778567|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.425|||<|0.0001|TWO_SIDED|95.0|0.331|0.547||The treatment effect was also assessed by hazard ratios using the Cox's proportional hazards model.|two-sided Wald test|||||0.547|0.331|< 0.0001
72403453|NCT01466387|144312600|NON_INFERIORITY_OR_EQUIVALENCE|GMC JE + Rab + MenACWY-CRM/GMC JE + Rab.|Ratio of GMC|0.91|||||TWO_SIDED|95.0|0.71|1.17||The testing was done by assessing the confidence interval of the ratio.|ANCOVA|The ANCOVA model included vaccine group and center as factors, age as covariate and was adjusted for baseline.||The primary criterion for immunogenicity (postvaccination, day 57) was that the lower limit of the two sided 95% CI around the observed ratio of geometric mean concentrations between the second dose of Japanese encephalitis and third dose of rabies virus vaccines given concomitantly with MenACWY-CRM197 to Japanese encephalitis and rabies virus vaccines given alone was greater than 0.5.||1.17|0.71|
72514892|NCT00084929|144560733|OTHER||Area Under the Curve (AUC)|0.89|||||TWO_SIDED|95.0|0.853|0.933||||||Accuracy: ROC analysis Receiver-operating-characteristic (ROC) curves were estimated with the use of data pooled from the radiologists because of the small number of positive cases reviewed by each radiologist.||0.933|0.853|
72514893|NCT00084929|144560733|OTHER||"Sensitivity: P(T+|D+)"|0.9|||||TWO_SIDED|95.0|0.838|0.96|||||Exact 95% confidence intervals were calculated for each radiologist, and large-sample 95% confidence intervals were calculated for overall estimates, with the use of standard errors that allowed for estimation of variation among radiologists.|"Sensitivity, for each radiologist, was calculated as the percentage of patients with lesions that were larger than or equal to the prespecified threshold and that were detected on both colonoscopy and CT colonography.~The per-patient sensitivity, specificity, positive predictive value, and negative predictive value were first estimated for each radiologist, and then the average values among the radiologists were calculated."||0.96|0.838|
72514894|NCT00084929|144560733|OTHER||"P(T-|D-)"|0.86|||||TWO_SIDED|95.0|0.813|0.9|||||Exact 95% confidence intervals were calculated for each radiologist, and large-sample 95% confidence intervals were calculated for overall estimates, with the use of standard errors that allowed for estimation of variation among radiologists.|Specificity, for each radiologist, was calculated as the percentage of patients who did not have lesions larger than the prespecified threshold on colonoscopy as well as CT colonography The per-patient sensitivity, specificity, positive predictive value, and negative predictive value were first estimated for each radiologist, and then the average values among the radiologists were calculated.||0.9|0.813|
72514895|NCT00084929|144560733|OTHER||"P(D+|T+)"|0.23|||||TWO_SIDED|95.0|0.194|0.273|||||Exact 95% confidence intervals were calculated for each radiologist, and large-sample 95% confidence intervals were calculated for overall estimates, with the use of standard errors that allowed for estimation of variation among radiologists.|Positive Predictive Value (PPV) the positive predictive value was calculated as the percentage of patients with CT colonographic findings that were also seen on colonoscopy||0.273|0.194|
72514896|NCT00084929|144560733|OTHER||"P(D-|T-)"|0.99|||||TWO_SIDED|95.0|0.99|0.998|||||Exact 95% confidence intervals were calculated for each radiologist, and large-sample 95% confidence intervals were calculated for overall estimates, with the use of standard errors that allowed for estimation of variation among radiologists.|Negative Predictive Value (NPV) the negative predictive value was calculated as the percentage of patients with no CT colonographic findings larger than the prespecified threshold that were not detected on colonoscopy.||0.998|0.990|
72514897|NCT00084929|144560734|OTHER||Area Under the Curve (AUC)|0.89|||||TWO_SIDED|95.0|0.853|0.93||||||"Accuracy: ROC analysis CTC lesions needed to be within 2 segments and 50% size of the lesions removed via colonoscopy to be considered detected"||0.93|0.853|
72514898|NCT00084929|144560734|OTHER||"Sensitivity: P(T+|D+)"|0.9|||||TWO_SIDED|95.0|0.832|0.96|||||Sensitivity indicates the percent of patients who had a lesions (of the specified size) detected by optical colonoscopy, which were detected by CTC|"Sensitivity CTC lesions needed to be within 2 segments and 50% size of the lesions removed via colonoscopy to be considered detected"||0.96|0.832|
72568125|NCT03222583|144667727|NON_INFERIORITY|The percentage of GT1-infected participants in Arm A with SVR12 was non-inferior to the historical SVR12 rate of 97% if the LCB of the 2-sided 95% CI for the percentage was \> 91%.|Percentage of Participants with SVR12|99.4|||||TWO_SIDED|95.0|98.3|100.0||||||In order to control the Type I error rate, a fixed sequence testing procedure was used for the 3 ranked primary efficacy endpoints. Only if success had been demonstrated for the first primary endpoint was testing to proceed to the second primary endpoint. Similarly, only if success had been demonstrated for the second primary endpoint was testing to proceed to the third primary endpoint.||100.0|98.3|
72403454|NCT02968979|144312617|OTHER|||||||0.0032|||||||likelihood-ratio test|||Statistical analysis applies to all rows and columns.||||0.0032
72514899|NCT00084929|144560734|OTHER||"P(T-|D-)"|0.86|||||TWO_SIDED|95.0|0.817|0.902|||||Specificity indicates the percent of patients who had not lesions detected on optical colonoscopy, who had no lesions detected on CTC.|"Specificity CTC lesions needed to be within 2 segments and 50% size of the lesions removed via colonoscopy to be considered detected"||0.902|0.817|
72568126|NCT03222583|144667728|NON_INFERIORITY|The percentage of GT2-infected participants in Arm A with SVR12 was non-inferior to the historical SVR12 rate of 95% if the LCB of the 2-sided 95% CI for the percentage was \> 89%.|Percentage of Participants with SVR12|97.8|||||TWO_SIDED|95.0|95.4|100.0||||||In order to control the Type I error rate, a fixed sequence testing procedure was used for the 3 ranked primary efficacy endpoints. Only if success had been demonstrated for the first primary endpoint was testing to proceed to the second primary endpoint. Similarly, only if success had been demonstrated for the second primary endpoint was testing to proceed to the third primary endpoint.||100.0|95.4|
72568127|NCT02072824|144667755|SUPERIORITY||Least Square Mean Difference|0.11|STANDARD_ERROR_OF_MEAN|0.153||0.4606|TWO_SIDED|95.0|-0.19|0.42|||ANCOVA|||Linear model with log transformed baseline seizure rate as continuous covariate and treatment, age stratum, and geographical region as fixed factor effects.||0.42|-0.19|0.4606
72514900|NCT00084929|144560734|OTHER||"P(D+|T+)"|0.25|||||TWO_SIDED|95.0|0.209|0.292||||||"Positive Predictive Value (PPV) CTC lesions needed to be within 2 segments and 50% size of the lesions removed via colonoscopy to be considered detected"||0.292|0.209|
72514901|NCT00084929|144560734|OTHER||"P(D-|T-)"|0.99|||||TWO_SIDED|95.0|0.99|0.998||||||"Negative Predictive Value (NPV) CTC lesions needed to be within 2 segments and 50% size of the lesions removed via colonoscopy to be considered detected"||0.998|0.990|
72624205|NCT00725985|144778567|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.497|||<|0.0001|TWO_SIDED|95.0|0.39|0.633||The treatment effect was also assessed by hazard ratios using the Cox's proportional hazards model.|two-sided Wald test|||||0.633|0.390|< 0.0001
72624206|NCT00725985|144778568|SUPERIORITY||Median Difference (Final Values)|-0.667|||<|0.0001|TWO_SIDED|95.0|-0.971|-0.5|||ANCOVA|||CUA lesions||-0.500|-0.971|<0.0001
72403455|NCT02968979|144312617|OTHER|||||||0.0008|||||||Chi-squared|||"Statistical Analysis 2 for Frequency of the Different Stages of Cachexia, excluding the refractory cachexia stage, in the General NSCLC Population According to Molecular Abnormalities Associated With NSCLC.~Statistical analysis applies to all rows and columns."||||0.0008
72568128|NCT02072824|144667755|SUPERIORITY||Least Square Mean Difference|-0.43|STANDARD_ERROR_OF_MEAN|0.185||0.0223|TWO_SIDED|95.0|-0.8|-0.06|||ANCOVA|||Linear model with log transformed baseline seizure rate as continuous covariate and treatment, age stratum, and geographical region as fixed factor effects.||-0.06|-0.80|0.0223
72568129|NCT02072824|144667756|SUPERIORITY||Odds Ratio (OR)|0.625||||0.2418|TWO_SIDED|95.0|0.284|1.373|||Regression, Logistic|||The dichotomized responder variable was analyzed using a logistic regression model via maximum likelihood estimation with treatment group, age stratum, and geographical region as a fixed effect covariates.||1.373|0.284|0.2418
72568130|NCT02072824|144667756|SUPERIORITY||Odds Ratio (OR)|1.622||||0.305|TWO_SIDED|95.0|0.644|4.086|||Regression, Logistic|||The dichotomized responder variable was analyzed using a logistic regression model via maximum likelihood estimation with treatment group, age stratum, and geographical region as a fixed effect covariates.||4.086|0.644|0.3050
72624207|NCT00725985|144778568|SUPERIORITY||Median Difference (Final Values)|-0.625|||<|0.0001|TWO_SIDED|95.0|-0.857|-0.429|||ANCOVA|||CUA lesions||-0.429|-0.857|<0.0001
72624208|NCT00725985|144778568|SUPERIORITY||Median Difference (Final Values)|-0.286|||<|0.0001|TWO_SIDED|95.0|-0.333|-0.167|||ANCOVA|||T1 Gd-Enhancing Lesions||-0.167|-0.333|<0.0001
72403456|NCT02968979|144312627|OTHER||||||<|0.0001|||||||Kruskal-Wallis|||Statistical analysis compares all cachexia stages.||||<0.0001
72487948|NCT05879107|144504540|NON_INFERIORITY|NI was to be demonstrated if the upper limit of the 2-sided 95% CI of the GMT ratio (as measured by the OP assay) between the Control group (at Day 31) versus Co-administration group (at Day 31) was \<=2.|GMT ratio|1.29|||||TWO_SIDED|95.0|1.07|1.55|||||The ANCOVA model, for logarithm-transformed titers, included the treatment group and age category at vaccination as fixed effects and the pre-dose log-10 titer as covariate.|Strep pneumoniae - serotype 18C||1.55|1.07|
72487949|NCT05879107|144504540|NON_INFERIORITY|NI was to be demonstrated if the upper limit of the 2-sided 95% CI of the GMT ratio (as measured by the OP assay) between the Control group (at Day 31) versus Co-administration group (at Day 31) was \<=2.|GMT ratio|1.39|||||TWO_SIDED|95.0|1.2|1.61|||||The ANCOVA model, for logarithm-transformed titers, included the treatment group and age category at vaccination as fixed effects and the pre-dose log-10 titer as covariate.|Strep pneumoniae - serotype 19A||1.61|1.20|
72487950|NCT05879107|144504540|NON_INFERIORITY|NI was to be demonstrated if the upper limit of the 2-sided 95% CI of the GMT ratio (as measured by the OP assay) between the Control group (at Day 31) versus Co-administration group (at Day 31) was \<=2.|GMT ratio|1.33|||||TWO_SIDED|95.0|1.12|1.57|||||The ANCOVA model, for logarithm-transformed titers, included the treatment group and age category at vaccination as fixed effects and the pre-dose log-10 titer as covariate.|Strep pneumoniae - serotype 19F||1.57|1.12|
72487951|NCT05879107|144504540|NON_INFERIORITY|NI was to be demonstrated if the upper limit of the 2-sided 95% CI of the GMT ratio (as measured by the OP assay) between the Control group (at Day 31) versus Co-administration group (at Day 31) was \<=2.|GMT ratio|1.34|||||TWO_SIDED|95.0|1.12|1.6|||||The ANCOVA model, for logarithm-transformed titers, included the treatment group and age category at vaccination as fixed effects and the pre-dose log-10 titer as covariate.|Strep pneumoniae - serotype 22F||1.60|1.12|
72487952|NCT05879107|144504540|NON_INFERIORITY|NI was to be demonstrated if the upper limit of the 2-sided 95% CI of the GMT ratio (as measured by the OP assay) between the Control group (at Day 31) versus Co-administration group (at Day 31) was \<=2.|GMT ratio|1.36|||||TWO_SIDED|95.0|1.09|1.71|||||The ANCOVA model, for logarithm-transformed titers, included the treatment group and age category at vaccination as fixed effects and the pre-dose log-10 titer as covariate.|Strep pneumoniae - serotype 23F||1.71|1.09|
72487953|NCT05879107|144504540|NON_INFERIORITY|NI was to be demonstrated if the upper limit of the 2-sided 95% CI of the GMT ratio (as measured by the OP assay) between the Control group (at Day 31) versus Co-administration group (at Day 31) was \<=2.|GMT ratio|1.4|||||TWO_SIDED|95.0|1.2|1.64|||||The ANCOVA model, for logarithm-transformed titers, included the treatment group and age category at vaccination as fixed effects and the pre-dose log-10 titer as covariate.|Strep pneumoniae - serotype 33F||1.64|1.20|
72568131|NCT00841906|144667777|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||< 0.001
72624209|NCT00725985|144778568|SUPERIORITY||Median Difference (Final Values)|-0.286|||<|0.0001|TWO_SIDED|95.0|-0.375|-0.167|||ANCOVA|||T1 Gd-Enhancing Lesions||-0.167|-0.375|<0.0001
72624210|NCT00725985|144778568|SUPERIORITY||Median Difference (Final Values)|-0.333|||<|0.0001|TWO_SIDED|95.0|-0.5|-0.167|||ANCOVA|||T2 Lesions||-0.167|-0.500|<0.0001
72624211|NCT00725985|144778568|SUPERIORITY||Median Difference (Final Values)|-0.286|||<|0.0001|TWO_SIDED|95.0|-0.429|-0.143|||ANCOVA|||T2 Lesions||-0.143|-0.429|<0.0001
72624212|NCT00725985|144778587|SUPERIORITY||Point Estimate|-1.7|||<|0.0001|TWO_SIDED|95.0|-37.2|0.0|||ANCOVA|||||0.000|-37.200|<0.0001
72403457|NCT02968979|144312627|OTHER||||||<|0.0001||||||Without refractory cachexia|Kruskal-Wallis|Without refractory cachexia||Statistical analysis compares all cachexia stages.||||<0.0001
72403458|NCT02968979|144312627|OTHER||||||<|0.0001|||||||Kruskal-Wallis|||Statistical analysis compares all cachexia stages.||||<0.0001
72403459|NCT02968979|144312627|OTHER||||||<|0.0001||||||Without refractory cachexia|Kruskal-Wallis|Without refractory cachexia||Statistical analysis compares all cachexia stages.||||<0.0001
72403460|NCT02968979|144312627|OTHER|||||||0.1085|||||||Kruskal-Wallis|||Statistical analysis compares all cachexia stages.||||0.1085
72403461|NCT02968979|144312627|OTHER|||||||0.0482||||||Without refractory cachexia|Kruskal-Wallis|Without refractory cachexia||Statistical analysis compares all cachexia stages.||||0.0482
72403462|NCT02968979|144312627|OTHER||||||<|0.0001|||||||Kruskal-Wallis|||Statistical analysis compares all cachexia stages.||||<0.0001
72403463|NCT02968979|144312627|OTHER||||||<|0.0001||||||Without refractory cachexia|Kruskal-Wallis|Without refractory cachexia||Statistical analysis compares all cachexia stages.||||<0.0001
72403464|NCT02968979|144312627|OTHER||||||<|0.0001|||||||Kruskal-Wallis|||Statistical analysis compares all cachexia stages.||||<0.0001
72403465|NCT02968979|144312627|OTHER||||||<|0.0001||||||Without refractory cachexia|Kruskal-Wallis|Without refractory cachexia||Statistical analysis compares all cachexia stages.||||<0.0001
72403466|NCT00788827|144312645|OTHER||||||<|0.05|||||||Mixed Models Analysis|||Each participants Hba1c (%) lab result was analysed pre and post stem cell infusion to achieve 2 mean readings per participant.||||<0.05
72403467|NCT01586819|144312650|SUPERIORITY||Z score|-3.3902||||0.002|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||The null hypothesis was that subjects receiving Botox A as an added pre-treatment would have lower scores on the facial wrinkle severity scale post-treatment.||||.002
72403468|NCT01586819|144312651|SUPERIORITY||Z score|3.6115||||0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||The null hypothesis was that subjects receiving Botox A as an added pre-treatment would have higher difference scores, pre- to post-treatment, on the facial wrinkle severity scale suggesting a more pronounced effect of the chemical peel in combination with the Botox A therapy.||||.001
72487954|NCT05879107|144504541|NON_INFERIORITY|NI was to be demonstrated if the upper limit of the 2-sided 95% CI of the GMT ratio between the Control group (at Day 61) versus Co-administration group (at Day 31) for RSV-A neutralizing titer was \<=1.5.|GMT ratio|1.06|||||TWO_SIDED|95.0|0.94|1.2|||||The ANCOVA model, for logarithm-transformed titers, included the treatment group and age category at vaccination as fixed effects and the pre-dose log-10 titer as covariate.|RSV-A||1.20|0.94|
72487955|NCT05879107|144504542|NON_INFERIORITY|NI was to be demonstrated if the upper limit of the 2-sided 95% CI of the GMT ratio between the Control group (at Day 61) versus Co-administration group (at Day 31) for RSV-B neutralizing titer was \<=1.5.|GMT ratio|1.0|||||TWO_SIDED|95.0|0.89|1.13|||||The ANCOVA model, for logarithm-transformed titers, included the treatment group and age category at vaccination as fixed effects and the pre-dose log-10 titer as covariate.|RSV-B||1.13|0.89|
72487956|NCT01748942|144504599|SUPERIORITY|||||||0.25|||||||Mixed Models Analysis|||||||0.25
72487957|NCT01748942|144504602|SUPERIORITY||||||<|0.001|||||||Log Rank|||||||<0.001
72487958|NCT01748942|144504603|SUPERIORITY|||||||0.009|||||||Wilcoxon (Mann-Whitney)|||||||0.009
72487959|NCT01748942|144504604|SUPERIORITY|||||||0.33|||||||Wilcoxon (Mann-Whitney)|||||||0.33
72487960|NCT01748942|144504605|SUPERIORITY|||||||0.96|||||||Wilcoxon (Mann-Whitney)|||||||0.96
72487961|NCT01748942|144504606|SUPERIORITY|||||||0.15|||||||Log Rank|||||||0.15
72487962|NCT03437564|144504607|EQUIVALENCE|The difference in the least square (LS) means between the formulations (dosing of one Vortioxetine 20 mg tablet - dosing of two Vortioxetine 10 mg tablets) and the two-sided 90% confidence interval (CI) were provided using a crossover analysis of variance (ANOVA) model. The shown data were anti-logs of LS means difference and CI. The ANOVA model included log-transformed (natural log) PK parameters AUClast as dependent variable, and treatment condition, group, and period as independent variables.|Point Estimate|0.996|||||TWO_SIDED|90.0|0.967|1.026|||ANOVA|||||1.026|0.967|
72487963|NCT03437564|144504608|EQUIVALENCE|The difference in the LS means between the formulations (dosing of one vortioxetine 20 mg tablet - dosing of two vortioxetine 10 mg tablets) and the two-sided 90% CI were provided using a crossover ANOVA model. The shown data were anti-logs of LS means difference and CI. The ANOVA model included log-transformed (natural log) PK parameters Cmax as dependent variable, and treatment condition, group, and period as independent variables.|Point Estimate|0.972|||||TWO_SIDED|90.0|0.937|1.008|||ANOVA|||||1.008|0.937|
72487964|NCT04037748|144504619|EQUIVALENCE|Bio-equivalence Analysis was performed with Equivalence Acceptance Range for 90% Confidence Interval (CI) as 80.00% - 125.00%.|Geometric least squares (LS) mean ratio|90.8|||||TWO_SIDED|90.0|86.3|95.6||||||||95.6|86.3|
72487965|NCT04037748|144504620|EQUIVALENCE|Bio-equivalence Analysis was performed with Equivalence Acceptance Range for 90% Confidence Interval (CI) as 80.00% - 125.00%.|Geometric least squares (LS) mean ratio|93.7|||||TWO_SIDED|90.0|88.2|99.5||||||||99.5|88.2|
72487966|NCT04037748|144504622|EQUIVALENCE|Bio-equivalence Analysis was performed with Equivalence Acceptance Range for 90% Confidence Interval (CI) as 80.00% - 125.00%.|Geometric least squares (LS) mean ratio|97.3|||||TWO_SIDED|90.0|94.7|100.0||||||||100.0|94.7|
72487967|NCT04037748|144504623|EQUIVALENCE|Bio-equivalence Analysis was performed with Equivalence Acceptance Range for 90% Confidence Interval (CI) as 80.00% - 125.00%.|Geometric least squares (LS) mean ratio|94.82|||||TWO_SIDED|90.0|92.0|97.8||||||||97.8|92.0|
72487968|NCT00942175|144504642|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.7|||||TWO_SIDED|90.0|0.6106|0.8026|||||The mean difference refers to the point estimates of the relative bioavailability. With its confidence intervals, it was obtained from the ANOVA model on the natural logarithm transformed data.|||0.8026|0.6106|
72487969|NCT00942175|144504642|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.734|||||TWO_SIDED|90.0|0.6516|0.8269|||||The mean difference refers to the point estimates of the relative bioavailability. With its confidence intervals, it was obtained from the ANOVA model on the natural logarithm transformed data.|||0.8269|0.6516|
72487970|NCT00942175|144504642|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.5564|||||TWO_SIDED|90.0|0.4877|0.6347|||||The mean difference refers to the point estimates of the relative bioavailability. With its confidence intervals, it was obtained from the ANOVA model on the natural logarithm transformed data.|||0.6347|0.4877|
72487971|NCT00942175|144504642|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.6783|||||TWO_SIDED|90.0|0.5063|0.9087|||||The mean difference refers to the point estimates of the relative bioavailability. With its confidence intervals, it was obtained from the ANOVA model on the natural logarithm transformed data.|||0.9087|0.5063|
72514902|NCT00084929|144560735|OTHER||Area Under the Curve (AUC)|0.88|||||TWO_SIDED|95.0|0.842|0.913||||||Accuracy: ROC analysis||0.913|0.842|
72568132|NCT00903448|144667781|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.9|STANDARD_ERROR_OF_MEAN|2.1|<|0.0001|TWO_SIDED|95.0||||The least squares treatment means, i.e. adjusted treatment means, and standard errors were computed from the analysis of variance models.|Mixed Models Analysis|||This study enrolled 40 subjects in order to complete a target of at least 30 evaluable subjects. For the purpose of determination of sample size, it was assumed that at least 30 subjects would have complete data for all 3 treatment periods. Assuming the true mean difference in % time that gastric pH \> 4.0 between Prilosec OTC and Prevacid was at least 6.5, it was estimated that there would be at least 80% power to detect a treatment difference in 2-sided testing at the 5% significance level.||||< 0.0001
72568133|NCT00912093|144667782|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Peto-Peto Wilcoxon|||||||<0.001
72568134|NCT00912093|144667783|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Peto-Peto Wilcoxon|||||||<0.001
72403469|NCT03979638|144312664|SUPERIORITY||Estimated percent change|-10.8||||0.1424|TWO_SIDED|95.0|-23.5|4.0|||Mixed Models Analysis|Intention To Treat (ITT), statistical analysis follows a Mixed Model which uses log-transformation|Percent change difference between BLU-5937 and placebo was estimated by 100 x \[e\^diff - 1\] where 'e' = exponent of difference; and 'diff' = the treatment mean difference from mixed model of change from baseline based on log-transformed data.|||4.0|-23.5|0.1424
72514903|NCT00084929|144560735|OTHER||"Sensitivity: P(T+|D+)"|0.87|||||TWO_SIDED|95.0|0.803|0.929|||||Sensitivity indicates the percent of patients who had a lesions (of the specified size) detected by optical colonoscopy, which were detected by CTC|Sensitivity||0.929|0.803|
72514904|NCT00084929|144560735|OTHER||"P(T-|D-)"|0.87|||||TWO_SIDED|95.0|0.825|0.909|||||Specificity indicates the percent of patients who had not lesions detected on optical colonoscopy, who had no lesions detected on CTC.|Specificity||0.909|0.825|
72514905|NCT00084929|144560735|OTHER||"P(D+|T+)"|0.31|||||TWO_SIDED|95.0|0.256|0.355||||||Positive Predictive Value (PPV)||0.355|0.256|
72514906|NCT00084929|144560735|OTHER||"P(D-|T-)"|0.99|||||TWO_SIDED|95.0|0.984|0.994||||||Negative Predictive Value (NPV)||0.994|0.984|
72514907|NCT00084929|144560736|OTHER||Area Under the Curve (AUC)|0.87|||||TWO_SIDED|95.0|0.833|0.902||||||Accuracy: ROC analysis||0.902|0.833|
72514908|NCT00084929|144560736|OTHER||"Sensitivity: P(T+|D+)"|0.84|||||TWO_SIDED|95.0|0.776|0.912|||||Sensitivity indicates the percent of patients who had a lesions (of the specified size) detected by optical colonoscopy, which were detected by CTC|Sensitivity||0.912|0.776|
72568135|NCT00912093|144667784|SUPERIORITY_OR_OTHER_LEGACY|||||||0.012|||||||Peto Peto Wilcoxon|||||||0.012
72568136|NCT00912093|144667785|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Peto-Peto Wilcoxon|||||||<0.001
72568137|NCT00912093|144667786|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Peto-Peto Wilcoxon|||||||<0.001
72568138|NCT04688931|144667811|OTHER|The analysis is descriptive in nature.|Cox Proportional Hazard|0.45|||||TWO_SIDED|95.0|0.29|0.68|||||The hazard ratio represents the relative risk of having an event in the treatment arm (numerator) versus the control arm (denominator).|||0.68|0.29|
72568139|NCT04688931|144667812|OTHER|The analysis is descriptive in nature.|Cox Proportional Hazard|0.46|||||TWO_SIDED|95.0|0.3|0.7|||||The hazard ratio represents the relative risk of having an event in the treatment arm (numerator) versus the control arm (denominator).|||0.70|0.30|
72514909|NCT00084929|144560736|OTHER||"P(T-|D-)"|0.87|||||TWO_SIDED|95.0|0.831|0.914|||||Specificity indicates the percent of patients who had not lesions detected on optical colonoscopy, who had no lesions detected on CTC.|Specificity||0.914|0.831|
72514910|NCT00084929|144560736|OTHER||"P(D+|T+)"|0.35|||||TWO_SIDED|95.0|0.299|0.397||||||Positive Predictive Value (PPV)||0.397|0.299|
72514911|NCT00084929|144560736|OTHER||"P(D-|T-)"|0.99|||||TWO_SIDED|95.0|0.98|0.992||||||Negative Predictive Value (NPV)||0.992|0.980|
72514912|NCT00084929|144560737|OTHER||Area Under the Curve (AUC)|0.84|||||TWO_SIDED|95.0|0.81|0.878||||||Accuracy: ROC analysis||0.878|0.810|
72514913|NCT00084929|144560737|OTHER||"Sensitivity: P(T+|D+)"|0.78|||||TWO_SIDED|95.0|0.711|0.849|||||Sensitivity indicates the percent of patients who had a lesions (of the specified size) detected by optical colonoscopy, which were detected by CTC|Sensitivity||0.849|0.711|
72514914|NCT00084929|144560737|OTHER||"P(T-|D-)"|0.88|||||TWO_SIDED|95.0|0.84|0.92|||||Specificity indicates the percent of patients who had not lesions detected on optical colonoscopy, who had no lesions detected on CTC.|Specificity||0.92|0.840|
72514915|NCT00084929|144560737|OTHER||"P(D+|T+)"|0.4|||||TWO_SIDED|95.0|0.335|0.463||||||Positive Predictive Value (PPV)||0.463|0.335|
72514916|NCT00084929|144560737|OTHER||"P(D-|T-)"|0.98|||||TWO_SIDED|95.0|0.971|0.984||||||Negative Predictive Value (NPV)||0.984|0.971|
72514917|NCT00084929|144560738|OTHER||Area Under the Curve (AUC)|0.8|||||TWO_SIDED|95.0|0.763|0.828||||||Accuracy: ROC analysis||0.828|0.763|
72514918|NCT00084929|144560738|OTHER||"Sensitivity: P(T+|D+)"|0.65|||||TWO_SIDED|95.0|0.579|0.727|||||Sensitivity indicates the percent of patients who had a lesions (of the specified size) detected by optical colonoscopy, which were detected by CTC|Sensitivity||0.727|0.579|
72514919|NCT00084929|144560738|OTHER||"P(T-|D-)"|0.89|||||TWO_SIDED|95.0|0.851|0.923|||||Specificity indicates the percent of patients who had not lesions detected on optical colonoscopy, who had no lesions detected on CTC.|Specificity||0.923|0.851|
72514920|NCT00084929|144560738|OTHER||"P(D+|T+)"|0.45|||||TWO_SIDED|95.0|0.389|0.513||||||Positive Predictive Value (PPV)||0.513|0.389|
72514921|NCT00084929|144560738|OTHER||"P(D-|T-)"|0.95|||||TWO_SIDED|95.0|0.941|0.965||||||Negative Predictive Value (NPV)||0.965|0.941|
72514922|NCT00084929|144560739|OTHER||"Sensitivity: P(T+|D+)"|0.84|STANDARD_ERROR_OF_MEAN|0.043|||||||||||Sensitivity indicates the percent of lesions in patients who had a lesions (of the specified size) detected by optical colonoscopy, which were detected by CTC|Sensitivity (per lesion (\>=10mm))||||
72514923|NCT00084929|144560740|OTHER||"Sensitivity: P(T+|D+)"|0.82|STANDARD_ERROR_OF_MEAN|0.042|||||||||||Sensitivity indicates the percent of lesions in patients who had a lesions (of the specified size) detected by optical colonoscopy, which were detected by CTC|Sensitivity (per lesion (\>=9mm))||||
72568140|NCT04688931|144667814|OTHER|The analysis is descriptive in nature.|Cox Proportional Hazard|0.46|||||TWO_SIDED|95.0|0.24|0.86|||||The hazard ratio represents the relative risk of having an event in the treatment arm (numerator) versus the control arm (denominator).|||0.86|0.24|
72568141|NCT00450619|144667822|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.5019||||0.041|TWO_SIDED|95.0|||||Log Rank|||||||0.041
72568142|NCT00450619|144667822|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.5019||||0.046|TWO_SIDED|95.0|||||Hazard Ratio|||||||0.046
72568143|NCT00450619|144667826|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.71||||0.3|TWO_SIDED|95.0|0.37|1.35|||Kaplan Meier|||||1.35|0.37|0.30
72568144|NCT00714493|144667854|SUPERIORITY_OR_OTHER||change from baseline||||<|0.001|||||||Wilcoxon signed rank test|||||||<0.001
72514924|NCT00084929|144560741|OTHER||"Sensitivity: P(T+|D+)"|0.8|STANDARD_ERROR_OF_MEAN|0.041|||TWO_SIDED||||||||Sensitivity indicates the percent of lesions in patients who had a lesions (of the specified size) detected by optical colonoscopy, which were detected by CTC|Sensitivity (per lesion \>=8mm)||||
72403470|NCT03979638|144312664|SUPERIORITY||Estimated percent change|-6.1||||0.4602|TWO_SIDED|95.0|-20.8|11.2|||Mixed Models Analysis|Intention To Treat (ITT), statistical analysis follows a Mixed Model which uses log-transformation|Percent change difference between BLU-5937 and placebo was estimated by 100 x \[e\^diff - 1\] where 'e' = exponent of difference; and 'diff' = the treatment mean difference from mixed model of change from baseline based on log-transformed data.|||11.2|-20.8|0.4602
72514925|NCT00084929|144560742|OTHER||"Sensitivity: P(T+|D+)"|0.75|STANDARD_ERROR_OF_MEAN|0.042|||||||||||Sensitivity indicates the percent of lesions in patients who had a lesions (of the specified size) detected by optical colonoscopy, which were detected by CTC|Sensitivity (per lesion \>=7mm)||||
72514926|NCT00084929|144560743|OTHER||"Sensitivity: P(T+|D+)"|0.7|STANDARD_ERROR_OF_MEAN|0.046|||||||||||Sensitivity indicates the percent of lesions in patients who had a lesions (of the specified size) detected by optical colonoscopy, which were detected by CTC|Sensitivity (per lesion \>=6mm)||||
72514927|NCT00084929|144560744|OTHER||"Sensitivity: P(T+|D+)"|0.59|STANDARD_ERROR_OF_MEAN|0.045|||||||||||Sensitivity indicates the percent of lesions in patients who had a lesions (of the specified size) detected by optical colonoscopy, which were detected by CTC|Sensitivity (per lesion \>=5mm)||||
72514928|NCT00424294|144560748|SUPERIORITY_OR_OTHER|||||||0.733|TWO_SIDED||||||Chi-squared|||||||0.733
72514929|NCT00424294|144560749|SUPERIORITY_OR_OTHER|||||||0.463|TWO_SIDED||||||Chi-squared|||Week 1: p-value was calculated by Chi-square test.||||0.463
72514930|NCT00424294|144560749|SUPERIORITY_OR_OTHER|||||||0.549|TWO_SIDED||||||Chi-squared|||Week 2: p-value was calculated by Chi-square test.||||0.549
72514931|NCT00424294|144560749|SUPERIORITY_OR_OTHER|||||||0.272|TWO_SIDED||||||Chi-squared|||Week 4: p-value was calculated by Chi-square test.||||0.272
72514932|NCT00424294|144560749|SUPERIORITY_OR_OTHER|||||||0.265|TWO_SIDED||||||Chi-squared|||Week 8: p-value was calculated by Chi-square test.||||0.265
72514933|NCT00424294|144560750|SUPERIORITY_OR_OTHER|||||||0.939|TWO_SIDED||||||Fisher Exact|||Week 4: p-value was calculated by Fisher exact test.||||0.939
72487972|NCT00942175|144504643|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.8573|||||TWO_SIDED|90.0|0.802|0.9165|||||The mean difference refers to the point estimates of the relative bioavailability. With its confidence intervals, it was obtained from the ANOVA model on the natural logarithm transformed data.|||0.9165|0.8020|
72487973|NCT00942175|144504643|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.9103|||||TWO_SIDED|90.0|0.8567|0.9672|||||The mean difference refers to the point estimates of the relative bioavailability. With its confidence intervals, it was obtained from the ANOVA model on the natural logarithm transformed data.|||0.9672|0.8567|
72487974|NCT00942175|144504643|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.6943|||||TWO_SIDED|90.0|0.6438|0.7487|||||The mean difference refers to the point estimates of the relative bioavailability. With its confidence intervals, it was obtained from the ANOVA model on the natural logarithm transformed data.|||0.7487|0.6438|
72487975|NCT00942175|144504643|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.8389|||||TWO_SIDED|90.0|0.644|1.0928|||||The mean difference refers to the point estimates of the relative bioavailability. With its confidence intervals, it was obtained from the ANOVA model on the natural logarithm transformed data.|||1.0928|0.6440|
72487976|NCT00942175|144504644|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.1016|||||TWO_SIDED|90.0|0.0348|8.1684|||||Included only participants with complete data for both regimens. Values are least squares mean difference.|||8.1684|0.0348|
72487977|NCT00942175|144504644|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.0474|||||TWO_SIDED|90.0|-0.8555|4.9503|||||Included only participants with complete data for both regimens. Values are least squares mean difference.|||4.9503|-0.8555|
72487978|NCT00942175|144504644|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.0407|||||TWO_SIDED|90.0|6.5219|15.5595|||||Included only participants with complete data for both regimens. Values are least squares mean difference.|||15.5595|6.5219|
72487979|NCT00942175|144504644|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.4437|||||TWO_SIDED|90.0|7.1791|15.7083|||||Included only participants with complete data for both regimens. Values are least squares mean difference.|||15.7083|7.1791|
72487980|NCT00942175|144504645|SUPERIORITY_OR_OTHER|||||||0.035||95.0||||From ANOVA models in which the least-square means between two regimens are compared.|ANOVA|||||||0.035
72487981|NCT00942175|144504645|SUPERIORITY_OR_OTHER|||||||0.445||90.0||||From ANOVA models in which the least-square means between two regimens are compared.|ANOVA|||||||0.445
72487982|NCT00942175|144504645|SUPERIORITY_OR_OTHER||||||<|0.001||90.0||||From ANOVA models in which the least-square means between two regimens are compared.|ANOVA|||||||<0.001
72487983|NCT00942175|144504645|SUPERIORITY_OR_OTHER||||||<|0.001||90.0||||From ANOVA models in which the least-square means between two regimens are compared.|ANOVA|||||||<0.001
72487984|NCT00942175|144504646|SUPERIORITY_OR_OTHER|||||||0.004||90.0||||From ANOVA models in which the least-square means between two regimens are compared.|ANOVA|||||||0.004
72487985|NCT00942175|144504646|SUPERIORITY_OR_OTHER|||||||0.148||90.0||||From ANOVA models in which the least-square means between two regimens are compared.|ANOVA|||||||0.148
72487986|NCT00942175|144504646|SUPERIORITY_OR_OTHER||||||<|0.001||90.0||||From ANOVA models in which the least-square means between two regimens are compared.|ANOVA|||||||<0.001
72487987|NCT00942175|144504646|SUPERIORITY_OR_OTHER||||||<|0.0001||90.0||||From ANOVA models in which the least-square means between two regimens are compared.|ANOVA|||||||<.0001
72487988|NCT00545064|144504658|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.2|STANDARD_DEVIATION|20.2||0.001||95.0|-0.6|7.0|||t-test, 2 sided|||"The change is the post-baseline value minus the baseline value.~Null Hypothesis: change in GSS-SYMP-6 score = 7"||7.0|-0.6|0.001
72487989|NCT00545064|144504658|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.2|STANDARD_DEVIATION|20.2||0.097||95.0|-0.6|7.0|||t-test, 2 sided|||"The change is the post-baseline value minus the baseline value.~Null Hypothesis: change in GSS-SYMP-6 = 0"||7.0|-0.6|0.097
72487990|NCT00545064|144504661|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-11.5|STANDARD_DEVIATION|5.3|<|0.001||95.0|-12.3|-10.7|||t-test, 2 sided|||"The change is the post-baseline value minus the baseline value.~Null Hypothesis: change in IOP = -4"||-10.7|-12.3|<0.001
72487991|NCT00545064|144504661|SUPERIORITY_OR_OTHER||Median Difference (Net)|-11.5|STANDARD_DEVIATION|5.3|<|0.001||95.0|-12.3|-10.7|||t-test, 2 sided|||"The change is the post-baseline value minus the baseline value.~Null Hypothesis: change in IOP = 0"||-10.7|-12.3|<0.001
72487992|NCT00258674|144504663|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.03||||0.307||95.0|||||Regression, Logistic|||We used a three-stage hierarchical model estimate the effect of the interventions on the change in endpoint from baseline to follow-up. Change scores for dichotomous measures were scored as -1, 0, or 1, with a positive value indicating increased guideline adherence or increased incidence of that process. We used ordered logistic models to test the hypothesis that patients in the intervention groups were more likely to meet guidelines or to receive these processes of care.||||0.307
72514934|NCT00424294|144560750|SUPERIORITY_OR_OTHER|||||||0.323|TWO_SIDED||||||Fisher Exact|||Week 8: p-value was calculated by Fisher exact test.||||0.323
72514935|NCT00424294|144560750|SUPERIORITY_OR_OTHER|||||||0.338|TWO_SIDED||||||Fisher Exact|||Week 12: p-value was calculated by Fisher exact test.||||0.338
72514936|NCT00424294|144560751|SUPERIORITY_OR_OTHER|||||||0.746|TWO_SIDED||||||Fisher Exact|||Week 12: p-value was calculated by Fisher exact test.||||0.746
72487993|NCT00258674|144504664|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.03||||0.551||95.0|||||Regression, Logistic|||We used a three-stage hierarchical model estimate the effect of the interventions on the change in endpoint from baseline to follow-up. Change scores for dichotomous measures were scored as -1, 0, or 1, with a positive value indicating increased guideline adherence or increased incidence of that process. We used ordered logistic models to test the hypothesis that patients in the intervention groups were more likely to meet guidelines or to receive these processes of care.||||0.551
72487994|NCT00258674|144504665|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01||||0.927||95.0|||||Regression, Logistic|||We used a three-stage hierarchical model estimate the effect of the interventions on the change in endpoint from baseline to follow-up. Change scores for dichotomous measures were scored as -1, 0, or 1, with a positive value indicating increased guideline adherence or increased incidence of that process. We used ordered logistic models to test the hypothesis that patients in the intervention groups were more likely to meet guidelines or to receive these processes of care.||||0.927
72487995|NCT00258674|144504666|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.09||||0.308||95.0|||||Regression, Logistic|||We used a three-stage hierarchical model estimate the effect of the interventions on the change in endpoint from baseline to follow-up. Change scores for dichotomous measures were scored as -1, 0, or 1, with a positive value indicating increased guideline adherence or increased incidence of that process. We used ordered logistic models to test the hypothesis that patients in the intervention groups were more likely to meet guidelines or to receive these processes of care.||||0.308
72487996|NCT00258674|144504667|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.05||||0.867||95.0|||||Regression, Logistic|||We used a three-stage hierarchical model estimate the effect of the interventions on the change in endpoint from baseline to follow-up. Change scores for dichotomous measures were scored as -1, 0, or 1, with a positive value indicating increased guideline adherence or increased incidence of that process. We used ordered logistic models to test the hypothesis that patients in the intervention groups were more likely to meet guidelines or to receive these processes of care.||||0.867
72487997|NCT00258674|144504668|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.98||||0.807||95.0|||||Regression, Logistic|||We used a three-stage hierarchical model estimate the effect of the interventions on the change in endpoint from baseline to follow-up. Change scores for dichotomous measures were scored as -1, 0, or 1, with a positive value indicating increased guideline adherence or increased incidence of that process. We used ordered logistic models to test the hypothesis that patients in the intervention groups were more likely to meet guidelines or to receive these processes of care.||||0.807
72487998|NCT00258674|144504669|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.55||||0.702||95.0|||||Regression, Logistic|||We used a three-stage hierarchical model estimate the effect of the interventions on the change in endpoint from baseline to follow-up. Change scores for dichotomous measures were scored as -1, 0, or 1, with a positive value indicating increased guideline adherence or increased incidence of that process. We used ordered logistic models to test the hypothesis that patients in the intervention groups were more likely to meet guidelines or to receive these processes of care.||||0.702
72487999|NCT00258674|144504670|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02||||0.413||95.0|||||Regression, Logistic|||We used a three-stage hierarchical model estimate the effect of the interventions on the change in endpoint from baseline to follow-up. Change scores for dichotomous measures were scored as -1, 0, or 1, with a positive value indicating increased guideline adherence or increased incidence of that process. We used ordered logistic models to test the hypothesis that patients in the intervention groups were more likely to meet guidelines or to receive these processes of care.||||0.413
72514937|NCT00424294|144560752|SUPERIORITY_OR_OTHER|||||||0.635|TWO_SIDED||||||ANCOVA|||Week 1: Analysis of covariance (ANCOVA) with treatment and site as independent variables and baseline as the covariate was used for the analysis.||||0.635
72514938|NCT00424294|144560752|SUPERIORITY_OR_OTHER|||||||0.044|TWO_SIDED||||||ANCOVA|||Week 2: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.||||0.044
72514939|NCT00424294|144560752|SUPERIORITY_OR_OTHER|||||||0.957|TWO_SIDED||||||ANCOVA|||Week 4: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.||||0.957
72514940|NCT00424294|144560752|SUPERIORITY_OR_OTHER|||||||0.597|TWO_SIDED||||||ANCOVA|||Week 8: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.||||0.597
72514941|NCT00424294|144560752|SUPERIORITY_OR_OTHER|||||||0.96|TWO_SIDED||||||ANCOVA|||Week 12: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.||||0.960
72514942|NCT00424294|144560753|SUPERIORITY_OR_OTHER|||||||0.252|TWO_SIDED||||||ANCOVA|||Week 1: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.||||0.252
72514943|NCT00424294|144560753|SUPERIORITY_OR_OTHER|||||||0.032|TWO_SIDED||||||ANCOVA|||Week 2: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.||||0.032
72514944|NCT00424294|144560753|SUPERIORITY_OR_OTHER|||||||0.031|TWO_SIDED||||||ANCOVA|||Week 4: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.||||0.031
72514945|NCT00424294|144560753|SUPERIORITY_OR_OTHER|||||||0.018|TWO_SIDED||||||ANCOVA|||Week 8: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.||||0.018
72514946|NCT00424294|144560753|SUPERIORITY_OR_OTHER|||||||0.17|TWO_SIDED||||||ANCOVA|||Week 12: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.||||0.170
72403471|NCT03979638|144312664|SUPERIORITY||Estimated percent change|-7.8||||0.4181|TWO_SIDED|95.0|-24.4|12.5|||Mixed Models Analysis|Intention To Treat (ITT), statistical analysis follows a Mixed Model which uses log-transformation|Percent change difference between BLU-5937 and placebo was estimated by 100 x \[e\^diff - 1\] where 'e' = exponent of difference; and 'diff' = the treatment mean difference from mixed model of change from baseline based on log-transformed data.|||12.5|-24.4|0.4181
72403472|NCT03979638|144312664|SUPERIORITY||Estimated percent change|-16.7||||0.0855|TWO_SIDED|95.0|-32.3|2.6|||Mixed Models Analysis|Intention To Treat (ITT), statistical analysis follows a Mixed Model which uses log-transformation|Percent change difference between BLU-5937 and placebo was estimated by 100 x \[e\^diff - 1\] where 'e' = exponent of difference; and 'diff' = the treatment mean difference from mixed model of change from baseline based on log-transformed data.|||2.6|-32.3|0.0855
72624213|NCT00725985|144778587|SUPERIORITY||Point Estimate|-28.6|||<|0.0001|TWO_SIDED|95.0|-117.3|0.0|||ANCOVA|||||0.000|-117.300|<0.0001
72403473|NCT03979638|144312665|SUPERIORITY||Estimated percent change|-20.3||||0.001|TWO_SIDED|95.0|-29.9|-9.5|||Mixed Models Analysis|Intention To Treat (ITT), statistical analysis follows a Mixed Model which uses log-transformation|Percent change difference between BLU-5937 and placebo was estimated by 100 x \[e\^diff - 1\] where 'e' = exponent of difference; and 'diff' = the treatment mean difference from mixed model of change from baseline based on log-transformed data.|||-9.5|-29.9|0.0010
72488000|NCT00258674|144504671|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01||||0.996||95.0|||||Regression, Logistic|||We used a three-stage hierarchical model estimate the effect of the interventions on the change in endpoint from baseline to follow-up. Change scores for dichotomous measures were scored as -1, 0, or 1, with a positive value indicating increased guideline adherence or increased incidence of that process. We used ordered logistic models to test the hypothesis that patients in the intervention groups were more likely to meet guidelines or to receive these processes of care.||||0.996
72488001|NCT00258674|144504672|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.02||||0.451||95.0|||||Regression, Logistic|||We used a three-stage hierarchical model estimate the effect of the interventions on the change in endpoint from baseline to follow-up. Change scores for dichotomous measures were scored as -1, 0, or 1, with a positive value indicating increased guideline adherence or increased incidence of that process. We used ordered logistic models to test the hypothesis that patients in the intervention groups were more likely to meet guidelines or to receive these processes of care.||||0.451
72624214|NCT02546323|144778615|OTHER||Estimated mean difference|-0.0103|STANDARD_ERROR_OF_MEAN|0.00445||0.02|TWO_SIDED|95.0|-0.0191|-0.0016||Statistical significance of the MeanMax CIMT annualized rate of change between rosuvastatin 20 mg and placebo was evaluated using time-by-treatment interaction term in the model.|Multi-level mixed effects model||Randomized treatment group, time, time-by-treatment interaction, ICVD risk stratification, carotid artery site, center, age, sex, and scan reader were fixed effects. Random effects were the intercept and slope for individual patients.|Comparison of annualized rate of change in MeanMax CIMT measurement difference between rosuvastatin 20 mg and placebo.||-0.0016|-0.0191|0.020
72624215|NCT02546323|144778616|OTHER||Estimated mean difference|-0.011|STANDARD_ERROR_OF_MEAN|0.00442||0.013|TWO_SIDED|95.0|-0.0197|-0.0024||Statistical significance of the MeanMax CIMT annualized rate of change between rosuvastatin 20 mg and placebo was evaluated using time-by-treatment interaction term in the model.|Multi-level mixed effects model||Randomized treatment group, time, time-by-treatment interaction, ICVD risk stratification, carotid artery site, center, age, sex, and scan reader were fixed effects. Random effects were the intercept and slope for individual patients.|Comparison of annualized rate of change in MeanMax CIMT measurement difference between rosuvastatin 20 mg and placebo.||-0.0024|-0.0197|0.013
72624216|NCT02546323|144778617|OTHER||Estimated mean difference|-0.0162|STANDARD_ERROR_OF_MEAN|0.00903||0.073|TWO_SIDED|95.0|-0.0339|0.0015||Statistical significance of the MeanMax CIMT annualized rate of change between rosuvastatin 20 mg and placebo was evaluated using time-by-treatment interaction term in the model.|Multi-level mixed effects model||Randomized treatment group, time, time-by-treatment interaction, ICVD risk stratification, carotid artery site, center, age, sex, and scan reader were fixed effects. Random effects were the intercept and slope for individual patients.|Comparison of annualized rate of change in MeanMax CIMT measurement difference between rosuvastatin 20 mg and placebo.||0.0015|-0.0339|0.073
72624217|NCT02546323|144778618|OTHER||Estimated mean difference|-0.0043|STANDARD_ERROR_OF_MEAN|0.00716||0.547|TWO_SIDED|95.0|-0.0183|0.0097||Statistical significance of the MeanMax CIMT annualized rate of change between rosuvastatin 20 mg and placebo was evaluated using time-by-treatment interaction term in the model.|Multi-level mixed effects model||Randomized treatment group, time, time-by-treatment interaction, ICVD risk stratification, carotid artery site, center, age, sex, and scan reader were fixed effects. Random effects were the intercept and slope for individual patients.|Comparison of annualized rate of change in MeanMax CIMT measurement difference between rosuvastatin 20 mg and placebo.||0.0097|-0.0183|0.547
72624218|NCT02546323|144778619|OTHER||Estimated mean difference|-0.0086|STANDARD_ERROR_OF_MEAN|0.00272||0.002|TWO_SIDED|95.0|-0.0139|-0.0032||Statistical significance of the MeanMean CIMT annualized rate of change between rosuvastatin 20 mg and placebo was evaluated using time-by-treatment interaction term in the model.|Multi-level mixed effects model||Randomized treatment group, time, time-by-treatment interaction, ICVD risk stratification, carotid artery site, center, age, sex, and scan reader were fixed effects. Random effects were the intercept and slope for individual patients|Comparison of annualized rate of change in MeanMean CIMT measurement difference between rosuvastatin 20 mg and placebo||-0.0032|-0.0139|0.002
72624219|NCT02546323|144778620|OTHER||Least squares mean difference|-35.46|STANDARD_ERROR_OF_MEAN|2.426|<|0.001|TWO_SIDED|95.0|-40.23|-30.7|||ANCOVA||Treatment as a fixed effect and baseline value as a covariate.|Treatment difference (rosuvastatin 20 mg - placebo): LDL-C||-30.70|-40.23|<0.001
72514947|NCT00424294|144560754|SUPERIORITY_OR_OTHER|||||||0.507|TWO_SIDED||||||ANCOVA|||Week 1: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.||||0.507
72514948|NCT00424294|144560754|SUPERIORITY_OR_OTHER|||||||0.743|TWO_SIDED||||||ANCOVA|||Week 2: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.||||0.743
72624220|NCT02546323|144778620|OTHER||Least squares mean difference|-21.85|STANDARD_ERROR_OF_MEAN|1.441|<|0.001|TWO_SIDED|95.0|-24.68|-19.02|||ANCOVA||Treatment as a fixed effect and baseline value as a covariate.|Treatment difference (rosuvastatin 20 mg - placebo): total cholesterol||-19.02|-24.68|<0.001
72403474|NCT03979638|144312665|SUPERIORITY||Estimated percent change|-17.7||||0.0186|TWO_SIDED|95.0|-29.9|-3.3|||Mixed Models Analysis|Intention To Treat (ITT), statistical analysis follows a Mixed Model which uses log-transformation|Percent change difference between BLU-5937 and placebo was estimated by 100 x \[e\^diff - 1\] where 'e' = exponent of difference; and 'diff' = the treatment mean difference from mixed model of change from baseline based on log-transformed data.|||-3.3|-29.9|0.0186
72403475|NCT03979638|144312665|SUPERIORITY||Estimated percent change|-19.4||||0.032|TWO_SIDED|95.0|-33.9|-1.9|||Mixed Models Analysis|Intention To Treat (ITT), statistical analysis follows a Mixed Model which uses log-transformation|Percent change difference between BLU-5937 and placebo was estimated by 100 x \[e\^diff - 1\] where 'e' = exponent of difference; and 'diff' = the treatment mean difference from mixed model of change from baseline based on log-transformed data.|||-1.9|-33.9|0.0320
72403476|NCT03979638|144312665|SUPERIORITY||Estimated percent change|-27.0||||0.0026|TWO_SIDED|95.0|-40.3|-10.8|||Mixed Models Analysis|Intention To Treat (ITT), statistical analysis follows a Mixed Model which uses log-transformation|Percent change difference between BLU-5937 and placebo was estimated by 100 x \[e\^diff - 1\] where 'e' = exponent of difference; and 'diff' = the treatment mean difference from mixed model of change from baseline based on log-transformed data.|||-10.8|-40.3|0.0026
72403477|NCT03979638|144312666|SUPERIORITY||Estimated percent change|-28.1||||0.0005|TWO_SIDED|95.0|-39.5|-14.5|||Mixed Models Analysis|Intention To Treat (ITT), statistical analysis follows a Mixed Model which uses log-transformation|Percent change difference between BLU-5937 and placebo was estimated by 100 x \[e\^diff - 1\] where 'e' = exponent of difference; and 'diff' = the treatment mean difference from mixed model of change from baseline based on log-transformed data.|||-14.5|-39.5|0.0005
72403478|NCT03979638|144312666|SUPERIORITY||Estimated percent change|-28.4||||0.0003|TWO_SIDED|95.0|-39.7|-15.0|||Mixed Models Analysis|Intention To Treat (ITT), statistical analysis follows a Mixed Model which uses log-transformation|Percent change difference between BLU-5937 and placebo was estimated by 100 x \[e\^diff - 1\] where 'e' = exponent of difference; and 'diff' = the treatment mean difference from mixed model of change from baseline based on log-transformed data.|||-15.0|-39.7|0.0003
72403479|NCT03979638|144312666|SUPERIORITY||Estimated percent change|-29.5||||0.0014|TWO_SIDED|95.0|-42.7|-13.2|||Mixed Models Analysis|Intention To Treat (ITT), statistical analysis follows a Mixed Model which uses log-transformation|Percent change difference between BLU-5937 and placebo was estimated by 100 x \[e\^diff - 1\] where 'e' = exponent of difference; and 'diff' = the treatment mean difference from mixed model of change from baseline based on log-transformed data.|||-13.2|-42.7|0.0014
72403480|NCT03979638|144312666|SUPERIORITY||Estimated percent change|-32.4||||0.0006|TWO_SIDED|95.0|-45.3|-16.4|||Mixed Models Analysis|Intention To Treat (ITT), statistical analysis follows a Mixed Model which uses log-transformation|Percent change difference between BLU-5937 and placebo was estimated by 100 x \[e\^diff - 1\] where 'e' = exponent of difference; and 'diff' = the treatment mean difference from mixed model of change from baseline based on log-transformed data.|||-16.4|-45.3|0.0006
72403481|NCT02586896|144312675|SUPERIORITY|||||||0.29|||||||ANOVA|||||||0.29
72403482|NCT02586896|144312677|SUPERIORITY|||||||0.91|||||||ANOVA|||||||0.91
72514949|NCT00424294|144560754|SUPERIORITY_OR_OTHER|||||||0.914|TWO_SIDED||||||ANCOVA|||Week 4: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.||||0.914
72514950|NCT00424294|144560754|SUPERIORITY_OR_OTHER|||||||0.715|TWO_SIDED||||||ANCOVA|||Week 8: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.||||0.715
72403483|NCT02586896|144312678|SUPERIORITY|||||||0.09|||||||ANOVA|||||||0.09
72403484|NCT02586896|144312679|SUPERIORITY|||||||0.54|||||||ANOVA|||||||0.54
72403485|NCT02678676|144312753|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.96||||0.3444|TWO_SIDED|95.0|0.88|1.04||No adjustment to the p-value|Regression, Cox|||Test for statistical difference between pioglitazone and placebo with respect to time of first occurrence of the primary composite outcome event.||1.04|0.88|0.3444
72403486|NCT02678676|144312754|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.98|||||TWO_SIDED|95.0|0.83|1.16||||||Test for statistical difference between pioglitazone and placebo with respect to time of first occurrence of the primary composite outcome event.||1.16|0.83|
72488002|NCT00258674|144504673|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.1||||0.447||95.0|||||Regression, Logistic|||We used a three-stage hierarchical model estimate the effect of the interventions on the change in endpoint from baseline to follow-up. Change scores for dichotomous measures were scored as -1, 0, or 1, with a positive value indicating increased guideline adherence or increased incidence of that process. We used ordered logistic models to test the hypothesis that patients in the intervention groups were more likely to meet guidelines or to receive these processes of care.||||0.447
72514951|NCT00424294|144560754|SUPERIORITY_OR_OTHER|||||||0.558|TWO_SIDED||||||ANCOVA|||Week 12: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.||||0.558
72514952|NCT00424294|144560755|SUPERIORITY_OR_OTHER|||||||0.172|TWO_SIDED||||||ANCOVA|||Week 1: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.||||0.172
72514953|NCT00424294|144560755|SUPERIORITY_OR_OTHER|||||||0.738|TWO_SIDED||||||ANCOVA|||Week 2: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.||||0.738
72514954|NCT00424294|144560755|SUPERIORITY_OR_OTHER|||||||0.948|TWO_SIDED||||||ANCOVA|||Week 4: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.||||0.948
72514955|NCT00424294|144560755|SUPERIORITY_OR_OTHER|||||||0.428|TWO_SIDED||||||ANCOVA|||Week 8: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.||||0.428
72514956|NCT00424294|144560755|SUPERIORITY_OR_OTHER|||||||0.861|TWO_SIDED||||||ANCOVA|||Week 12: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.||||0.861
72514957|NCT00424294|144560756|SUPERIORITY_OR_OTHER|||||||0.325|TWO_SIDED||||||ANCOVA|||Week 1: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.||||0.325
72514958|NCT00424294|144560756|SUPERIORITY_OR_OTHER|||||||0.386|TWO_SIDED||||||ANCOVA|||Week 2: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.||||0.386
72514959|NCT00424294|144560756|SUPERIORITY_OR_OTHER|||||||0.532|TWO_SIDED||||||ANCOVA|||Week 4: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.||||0.532
72514960|NCT00424294|144560756|SUPERIORITY_OR_OTHER|||||||0.909|TWO_SIDED||||||ANCOVA|||Week 8: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.||||0.909
72514961|NCT00424294|144560756|SUPERIORITY_OR_OTHER|||||||0.994|TWO_SIDED||||||ANCOVA|||Week 12: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.||||0.994
72514962|NCT00424294|144560757|SUPERIORITY_OR_OTHER|||||||0.369|TWO_SIDED||||||ANCOVA|||Week 1: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.||||0.369
72514963|NCT00424294|144560757|SUPERIORITY_OR_OTHER|||||||0.666|TWO_SIDED||||||ANCOVA|||Week 2: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.||||0.666
72514964|NCT00424294|144560757|SUPERIORITY_OR_OTHER|||||||0.53|TWO_SIDED||||||ANCOVA|||Week 4: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.||||0.530
72514965|NCT00424294|144560757|SUPERIORITY_OR_OTHER|||||||0.632|TWO_SIDED||||||ANCOVA|||Week 8: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.||||0.632
72514966|NCT00424294|144560757|SUPERIORITY_OR_OTHER|||||||0.801|TWO_SIDED||||||ANCOVA|||Week 12: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.||||0.801
72514967|NCT00424294|144560758|SUPERIORITY_OR_OTHER|||||||0.052|TWO_SIDED||||||ANCOVA|||Week 1: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.||||0.052
72514968|NCT00424294|144560758|SUPERIORITY_OR_OTHER|||||||0.108|TWO_SIDED||||||ANCOVA|||Week 2: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.||||0.108
72514969|NCT00424294|144560758|SUPERIORITY_OR_OTHER|||||||0.573|TWO_SIDED||||||ANCOVA|||Week 4: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.||||0.573
72514970|NCT00424294|144560758|SUPERIORITY_OR_OTHER|||||||0.342|TWO_SIDED||||||ANCOVA|||Week 8: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.||||0.342
72514971|NCT00424294|144560758|SUPERIORITY_OR_OTHER|||||||0.501|TWO_SIDED||||||ANCOVA|||Week 12: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.||||0.501
72514972|NCT00424294|144560759|SUPERIORITY_OR_OTHER|||||||0.701|TWO_SIDED||||||ANCOVA|||Week 1: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.||||0.701
72514973|NCT00424294|144560759|SUPERIORITY_OR_OTHER|||||||0.167|TWO_SIDED||||||ANCOVA|||Week 2: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.||||0.167
72514974|NCT00424294|144560759|SUPERIORITY_OR_OTHER|||||||0.948|TWO_SIDED||||||ANCOVA|||Week 4: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.||||0.948
72514975|NCT00424294|144560759|SUPERIORITY_OR_OTHER|||||||0.834|TWO_SIDED||||||ANCOVA|||Week 8: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.||||0.834
72514976|NCT00424294|144560759|SUPERIORITY_OR_OTHER|||||||0.977|TWO_SIDED||||||ANCOVA|||Week 12: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.||||0.977
72514977|NCT00424294|144560760|SUPERIORITY_OR_OTHER|||||||0.291|TWO_SIDED||||||ANCOVA|||Week 1: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.||||0.291
72514978|NCT00424294|144560760|SUPERIORITY_OR_OTHER|||||||0.08|TWO_SIDED||||||ANCOVA|||Week 2: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.||||0.080
72514979|NCT00424294|144560760|SUPERIORITY_OR_OTHER|||||||0.466|TWO_SIDED||||||ANCOVA|||Week 4: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.||||0.466
72514980|NCT00424294|144560760|SUPERIORITY_OR_OTHER|||||||0.267|TWO_SIDED||||||ANCOVA|||Week 8: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.||||0.267
72514981|NCT00424294|144560760|SUPERIORITY_OR_OTHER|||||||0.1|TWO_SIDED||||||ANCOVA|||Week 12: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.||||0.100
72514982|NCT04397718|144560770|SUPERIORITY||Odds Ratio (OR)|1.19||||0.667|TWO_SIDED|95.0|0.46|3.06|||Chi-squared||Logistic regression adjusted for age, hypertension, and COPD|||3.06|0.46|0.667
72514983|NCT04397718|144560771|SUPERIORITY||Hazard Ratio (HR)|0.93||||0.876|TWO_SIDED|95.0|0.58|1.49|||Log Rank||Cox regression model adjusted for age, hypertension, and COPD.|||1.49|0.58|0.876
72514984|NCT04397718|144560772|SUPERIORITY||Odds Ratio (OR)|0.95||||0.991|TWO_SIDED|95.0|0.31|2.92|||Chi-squared||Logistic regression adjusted for age, hypertension, and COPD.|||2.92|0.31|0.991
72514985|NCT04397718|144560773|SUPERIORITY||Quantile Regression|0.0||||0.841|TWO_SIDED|95.0|-2.03|4.11|||Wilcoxon (Mann-Whitney)||Adjusted for age, hypertension, and COPD|||4.11|-2.03|0.841
72514986|NCT04397718|144560774|SUPERIORITY||Quantile Regression|0.0||||0.746|TWO_SIDED|95.0|0.0|0.0|||Wilcoxon (Mann-Whitney)||Adjusted for age, hypertension, and COPD|||0|0|0.746
72514987|NCT04397718|144560775|SUPERIORITY||Hazard Ratio (HR)|2.3||||0.1|TWO_SIDED|95.0|0.72|7.39|||Log Rank||Cox regression model adjusted for age, hypertension, and COPD|||7.39|0.72|0.1
72514988|NCT04397718|144560776|SUPERIORITY||Odds Ratio (OR)|0.82||||0.425|TWO_SIDED|95.0|0.33|2.0|||Fisher Exact||||Logistical regression adjusted for age, hypertension, COPD, and baseline severity score.|2|0.33|0.425
72514989|NCT04397718|144560777|SUPERIORITY||Odds Ratio (OR)|1.22||||0.688|TWO_SIDED|95.0|0.44|3.42|||Chi-squared||Logistic regression adjusted for age, hypertension, and COPD.|||3.42|0.44|0.688
72514990|NCT01797965|144560794|SUPERIORITY|||||||0.5937|||||||ANCOVA|Based on ranks and adjusted for the baseline Z-score, baseline age (\<=35 vs \>35) and history of prior IFN beta.||Change to Week 12||||0.5937
72514991|NCT01797965|144560794|SUPERIORITY|||||||0.6233|||||||ANCOVA|Based on ranks and adjusted for the baseline Z-score, baseline age (\<=35 vs \>35) and history of prior IFN beta.||Change to Week 24||||0.6233
72514992|NCT01797965|144560794|SUPERIORITY|||||||0.1884|||||||ANCOVA|Based on ranks and adjusted for the baseline Z-score, baseline age (\<=35 vs \>35) and history of prior IFN beta.||Change to Week 48||||0.1884
72514993|NCT01797965|144560795|SUPERIORITY|||||||0.0204|||||||ANCOVA|Based on ranks and adjusted for the baseline Z-score, baseline age (\<=35 vs \>35) and history of prior IFN beta.||Change from Baseline 301 to Week 12 for 301||||0.0204
72568145|NCT00714493|144667855|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon signed rank test|||||||<0.001
72403487|NCT00851799|144312762|SUPERIORITY_OR_OTHER||Difference in annual rate of change|-4.7||||0.013|TWO_SIDED|97.5|-8.9|-0.4||Inference was assessed against a type I error of 2.5% to account for multiple comparisons.|Mixed Models Analysis||The difference in the rate of CIMT change (Cohort A: ATV/RTV + FTC/TDF - Cohort C: DRV/RTV + FTC/TDF) was estimated by mixed effects linear regression model that adjusted for screening HIV-1 RNA level and Framingham risk score stratification factors.|The primary hypothesis was that rate of change of CIMT would be faster over 144 weeks in participants initiating a RTV-boosted protease inhibitor-containing regimen (the pooled ATV/RTV and DRV/RTV groups) compared with a RAL-containing regimen. However, In the event of a significant difference between ATV/RTV and DRV/RTV groups, the study was designed to make all pairwise treatment group comparisons.||-0.4|-8.9|0.013
72488003|NCT00258674|144504674|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.01||||0.936||95.0|||||Regression, Logistic|||We used a three-stage hierarchical model estimate the effect of the interventions on the change in endpoint from baseline to follow-up. Change scores for dichotomous measures were scored as -1, 0, or 1, with a positive value indicating increased guideline adherence or increased incidence of that process. We used ordered logistic models to test the hypothesis that patients in the intervention groups were more likely to meet guidelines or to receive these processes of care.||||0.936
72514994|NCT01797965|144560795|SUPERIORITY|||||||0.0805|||||||ANCOVA|Based on ranks and adjusted for the baseline Z-score, baseline age (\<=35 vs \>35) and history of prior IFN beta.||Change from Baseline 301 to Week 24 for 301||||0.0805
72514995|NCT01797965|144560795|SUPERIORITY|||||||0.2535|||||||ANCOVA|Based on ranks and adjusted for the baseline Z-score, baseline age (\<=35 vs \>35) and history of prior IFN beta.||Change from Baseline 301 to Week 36 for 301||||0.2535
72514996|NCT01797965|144560795|SUPERIORITY|||||||0.4738|||||||ANCOVA|Based on ranks and adjusted for the baseline Z-score, baseline age (\<=35 vs \>35) and history of prior IFN beta.||Change from Baseline 301 to Week 48 for 301||||0.4738
72514997|NCT01797965|144560795|SUPERIORITY|||||||0.2302|||||||ANCOVA|Based on ranks and adjusted for the baseline Z-score, baseline age (\<=35 vs \>35) and history of prior IFN beta.||Change from Baseline 301 to Week 60 for 301||||0.2302
72568146|NCT00354341|144667861|SUPERIORITY_OR_OTHER|||||||0.8811|TWO_SIDED|||||P-value was calculated by ANCOVA with last observation carry forward (LOCF) method.|ANCOVA with LOCF|||||||0.8811
72568147|NCT00354341|144667862|SUPERIORITY_OR_OTHER|||||||0.8864|TWO_SIDED||||||ANCOVA with LOCF|||||||0.8864
72568148|NCT00354341|144667863|SUPERIORITY_OR_OTHER|||||||0.5681|TWO_SIDED||||||ANCOVA with LOCF|||||||0.5681
72568149|NCT00354341|144667864|SUPERIORITY_OR_OTHER|||||||0.1578|TWO_SIDED||||||ANCOVA with LOCF|||||||0.1578
72568150|NCT00354341|144667865|SUPERIORITY_OR_OTHER|||||||0.2913|TWO_SIDED||||||ANCOVA with LOCF|||||||0.2913
72488004|NCT00258674|144504675|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.04||||0.332||95.0||||A comparison of the claims vs. claims+MR arms was also conducted, giving a p-value of 0.537.|Regression, Logistic|||We used a three-stage hierarchical model estimate the effect of the interventions on the change in endpoint from baseline to follow-up. Change scores for dichotomous measures were scored as -1, 0, or 1, with a positive value indicating increased guideline adherence or increased incidence of that process. We used ordered logistic models to test the hypothesis that patients in the intervention groups were more likely to meet guidelines or to receive these processes of care.||||0.332
72488005|NCT00258674|144504676|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.01||||0.86||95.0|||||Regression, Logistic|||We used a three-stage hierarchical model estimate the effect of the interventions on the change in endpoint from baseline to follow-up. Change scores for dichotomous measures were scored as -1, 0, or 1, with a positive value indicating increased guideline adherence or increased incidence of that process. We used ordered logistic models to test the hypothesis that patients in the intervention groups were more likely to meet guidelines or to receive these processes of care.||||0.860
72488006|NCT00258674|144504677|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.03||||0.382||95.0|||||Regression, Logistic|||We used a three-stage hierarchical model estimate the effect of the interventions on the change in endpoint from baseline to follow-up. Change scores for dichotomous measures were scored as -1, 0, or 1, with a positive value indicating increased guideline adherence or increased incidence of that process. We used ordered logistic models to test the hypothesis that patients in the intervention groups were more likely to meet guidelines or to receive these processes of care.||||0.382
72488007|NCT00258674|144504678|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01||||0.988||95.0|||||Regression, Logistic|||We used a three-stage hierarchical model estimate the effect of the interventions on the change in endpoint from baseline to follow-up. Change scores for dichotomous measures were scored as -1, 0, or 1, with a positive value indicating increased guideline adherence or increased incidence of that process. We used ordered logistic models to test the hypothesis that patients in the intervention groups were more likely to meet guidelines or to receive these processes of care.||||0.988
72488008|NCT00258674|144504679|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01||||0.685||95.0|||||Regression, Logistic|||We used a three-stage hierarchical model estimate the effect of the interventions on the change in endpoint from baseline to follow-up. Change scores for dichotomous measures were scored as -1, 0, or 1, with a positive value indicating increased guideline adherence or increased incidence of that process. We used ordered logistic models to test the hypothesis that patients in the intervention groups were more likely to meet guidelines or to receive these processes of care.||||0.685
72488009|NCT03715153|144504680|SUPERIORITY||Estimate of the adjusted difference|0.35|STANDARD_ERROR_OF_MEAN|0.71||0.617|TWO_SIDED|95.0|-1.04|1.75|||t-test, 2 sided|General Linear Model including the fixed, categorical effects of treatment, country, gender, as well as the continuous, fixed covariates of baseline.|Estimate of the adjusted difference was based on 211 patients (Missing data were imputed).|||1.75|-1.04|0.617
72488010|NCT03715153|144504681|SUPERIORITY||Estimate of the adjusted difference|0.48|STANDARD_ERROR_OF_MEAN|3.26|||TWO_SIDED|95.0|-5.91|6.88|||||General Linear Model including the fixed, categorical effects of treatment, country, gender, as well as the continuous, fixed covariates of baseline. Estimate of the adjusted difference was based on 211 patients (Missing data were imputed).|||6.88|-5.91|
72488011|NCT03715153|144504682|SUPERIORITY||Estimate of the adjusted difference|-0.04|STANDARD_ERROR_OF_MEAN|0.1|||TWO_SIDED|95.0|-0.24|0.16|||||Rank-based analysis (Wilcoxon scores) including terms for fixed categorical effects of treatment, country and gender. Estimate of the adjusted difference was based on 211 patients (Missing data were imputed).|||0.16|-0.24|
72403488|NCT00851799|144312762|SUPERIORITY_OR_OTHER||Difference in annual rate of change|-2.8||||0.15|TWO_SIDED|97.5|-7.0|1.5||Inference was assessed against a type I error of 2.5% to account for multiple comparisons.|Mixed Models Analysis||The difference in the rate of CIMT change (Cohort A: ATV/RTV + FTC/TDF - Cohort B: RAL + FTC/TDF) was estimated by mixed effects linear regression model that adjusted for screening HIV-1 RNA level and Framingham risk score stratification factors.|The primary hypothesis was that rate of change of CIMT would be faster over 144 weeks in participants initiating a RTV-boosted protease inhibitor-containing regimen (the pooled ATV/RTV and DRV/RTV groups) compared with a RAL-containing regimen. However, In the event of a significant difference between ATV/RTV and DRV/RTV groups, the study was designed to make all pairwise treatment group comparisons.||1.5|-7.0|0.15
72403489|NCT00851799|144312762|SUPERIORITY_OR_OTHER||Difference in annual rate of change|1.9||||0.31|TWO_SIDED|97.5|-2.4|6.2||Inference was assessed against a type I error of 2.5% to account for multiple comparisons.|Mixed Models Analysis||The difference in the rate of CIMT change (Cohort C: DRV/RTV + FTC/TDF - Cohort B: RAL + FTC/TDF) was estimated by mixed effects linear regression model that adjusted for screening HIV-1 RNA level and Framingham risk score stratification factors.|The primary hypothesis was that rate of change of CIMT would be faster over 144 weeks in participants initiating a RTV-boosted protease inhibitor-containing regimen (the pooled ATV/RTV and DRV/RTV groups) compared with a RAL-containing regimen. However, In the event of a significant difference between ATV/RTV and DRV/RTV groups, the study was designed to make all pairwise treatment group comparisons.||6.2|-2.4|0.31
72488012|NCT03715153|144504683|SUPERIORITY||Estimate of the adjusted difference|0.16|STANDARD_ERROR_OF_MEAN|0.81|||TWO_SIDED|95.0|-1.42|1.75|||||General Linear Model including the fixed, categorical effects of treatment, country, gender, as well as the continuous, fixed covariates of baseline. Estimate of the adjusted difference was based on 211 patients (Missing data were imputed).|||1.75|-1.42|
72514998|NCT01797965|144560795|SUPERIORITY|||||||0.8522|||||||ANCOVA|Based on ranks and adjusted for the baseline Z-score, baseline age (\<=35 vs \>35) and history of prior IFN beta.||Change from Baseline 301 to Week 72 for 301||||0.8522
72514999|NCT01797965|144560795|SUPERIORITY|||||||0.0431|||||||ANCOVA|Based on ranks and adjusted for the baseline Z-score, baseline age (\<=35 vs \>35) and history of prior IFN beta.||Change from Baseline 301 to Week 84 for 301||||0.0431
72488013|NCT03715153|144504687|SUPERIORITY||Estimate of the adjusted difference|-0.26|STANDARD_ERROR_OF_MEAN|2.48|||TWO_SIDED|95.0|-5.12|4.59||||||||4.59|-5.12|
72515000|NCT01797965|144560795|SUPERIORITY|||||||0.0339|||||||ANCOVA|Based on ranks and adjusted for the baseline Z-score, baseline age (\<=35 vs \>35) and history of prior IFN beta.||Change from Baseline 301 to Week 96 for 301||||0.0339
72515001|NCT01797965|144560795|SUPERIORITY|||||||0.3195|||||||ANCOVA|Based on ranks and adjusted for the baseline Z-score, baseline age (\<=35 vs \>35) and history of prior IFN beta.||Change from Baseline 301 to Week 108 for 301||||0.3195
72515002|NCT01797965|144560795|SUPERIORITY|||||||0.2119|||||||ANCOVA|Based on ranks and adjusted for the baseline Z-score, baseline age (\<=35 vs \>35) and history of prior IFN beta.||Change from Baseline 301 to Week 120 for 301||||0.2119
72515003|NCT01797965|144560795|SUPERIORITY|||||||0.3619|||||||ANCOVA|Based on ranks and adjusted for the baseline Z-score, baseline age (\<=35 vs \>35) and history of prior IFN beta.||Change from Baseline 301 to Week 132 for 301||||0.3619
72515004|NCT01797965|144560795|SUPERIORITY|||||||0.017|||||||ANCOVA|Based on ranks and adjusted for the baseline Z-score, baseline age (\<=35 vs \>35) and history of prior IFN beta.||Change from Baseline 301 to Week 144 for 301||||0.0170
72515005|NCT01797965|144560795|SUPERIORITY|||||||0.017|||||||ANCOVA|Based on ranks and adjusted for the baseline Z-score, baseline age (\<=35 vs \>35) and history of prior IFN beta.||Change from Baseline 301 to Baseline 303||||0.0170
72515006|NCT01797965|144560795|SUPERIORITY|||||||0.0849|||||||ANCOVA|Based on ranks and adjusted for the baseline Z-score, baseline age (\<=35 vs \>35) and history of prior IFN beta.||Change from Baseline 301 to Week 12 for 303||||0.0849
72515007|NCT01797965|144560795|SUPERIORITY|||||||0.0057|||||||ANCOVA|Based on ranks and adjusted for the baseline Z-score, baseline age (\<=35 vs \>35) and history of prior IFN beta.||Change from Baseline 301 to Week 24 for 303||||0.0057
72515008|NCT01797965|144560795|SUPERIORITY|||||||0.396|||||||ANCOVA|Based on ranks and adjusted for the baseline Z-score, baseline age (\<=35 vs \>35) and history of prior IFN beta.||Change from Baseline 301 to Week 48 for 303||||0.3960
72515009|NCT01797965|144560797|SUPERIORITY||Odds Ratio (OR)|0.902||||0.8417|TWO_SIDED|95.0|0.329|2.473|||Regression, Logistic|Adjusted for the baseline relapse rate, history of prior IFN beta use (yes/no), baseline EDSS (\<=2.5 vs \>2.5) and baseline age (\<=35 vs \>35).||||2.473|0.329|0.8417
72515010|NCT01797965|144560819|SUPERIORITY|||||||0.3813|||||||ANCOVA|Based on ranks and adjusted for the baseline raw score, baseline age (\<=35 vs \>35) and history of prior IFN beta.||Change to Week 12||||0.3813
72515011|NCT01797965|144560819|SUPERIORITY|||||||0.1679|||||||ANOVA|Based on ranks and adjusted for the baseline raw score, baseline age (\<=35 vs \>35) and history of prior IFN beta.||Change to Week 24||||0.1679
72515012|NCT01797965|144560819|SUPERIORITY|||||||0.5634|||||||ANCOVA|Based on ranks and adjusted for the baseline raw score, baseline age (\<=35 vs \>35) and history of prior IFN beta.||Change to Week 48||||0.5634
72515013|NCT01797965|144560819|SUPERIORITY|||||||0.7003|||||||ANCOVA|Based on ranks and adjusted for the baseline raw score, baseline age (\<=35 vs \>35) and history of prior IFN beta.||Change to Week 144||||0.7003
72515014|NCT01797965|144560819|SUPERIORITY|||||||0.7812|||||||ANCOVA|Based on ranks and adjusted for the baseline raw score, baseline age (\<=35 vs \>35) and history of prior IFN beta.||Change to Week 168||||0.7812
72515015|NCT01797965|144560819|SUPERIORITY|||||||0.3246|||||||ANCOVA|Based on ranks and adjusted for the baseline raw score, baseline age (\<=35 vs \>35) and history of prior IFN beta.||Change to Week 192||||0.3246
72568151|NCT00354341|144667866|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Chi-squared, Corrected|||||||<0.001
72403490|NCT00851799|144312763|SUPERIORITY_OR_OTHER||Difference in Change|0.24||||0.53|TWO_SIDED|97.5|-0.63|1.11||Inference was assessed against a type I error of 2.5% to account for multiple comparisons.|Regression, Linear||The difference in change in relative FMD (Cohort A: ATV/RTV+FTC/TDF - Cohort C: DRV/RTV+FTC/TDF); estimated by linear regression that adjusted for study entry BA diameter and screening HIV-1 RNA level and Framingham risk score stratification factors.|The study was designed to compare change from study entry to week 24 in brachial artery (BA) flow mediated dilation (FMD) between a RTV-boosted protease inhibitor-containing regimen (the pooled ATV/RTV and DRV/RTV groups) and a RAL-containing regimen. However, in the event of a significant difference between ATV/RTV and DRV/RTV groups, the study was designed to make all pairwise treatment group comparisons.||1.11|-0.63|0.53
72515016|NCT01797965|144560819|SUPERIORITY|||||||0.6423|||||||ANCOVA|Based on ranks and adjusted for the baseline raw score, baseline age (\<=35 vs \>35) and history of prior IFN beta.||Change to Week 216||||0.6423
72515017|NCT01797965|144560819|SUPERIORITY|||||||0.0288|||||||ANCOVA|Based on ranks and adjusted for the baseline raw score, baseline age (\<=35 vs \>35) and history of prior IFN beta.||Change to Week 240||||0.0288
72515018|NCT01797965|144560820|SUPERIORITY|||||||0.2567|||||||ANCOVA|Based on ranks and adjusted for the baseline raw score, baseline age (\<=35 vs \>35) and history of prior IFN beta.||Change from Baseline 301 to Week 12 for 301||||0.2567
72515019|NCT01797965|144560820|SUPERIORITY|||||||0.6152|||||||ANCOVA|Based on ranks and adjusted for the baseline raw score, baseline age (\<=35 vs \>35) and history of prior IFN beta.||Change from Baseline 301 to Week 24 for 301||||0.6152
72515020|NCT01797965|144560820|SUPERIORITY|||||||0.2024|||||||ANCOVA|Based on ranks and adjusted for the baseline raw score, baseline age (\<=35 vs \>35) and history of prior IFN beta.||Change from Baseline 301 to Week 36 for 301||||0.2024
72515021|NCT01797965|144560820|SUPERIORITY|||||||0.9988|||||||ANCOVA|Based on ranks and adjusted for the baseline raw score, baseline age (\<=35 vs \>35) and history of prior IFN beta.||Change from Baseline 301 to Week 48 for 301||||0.9988
72515022|NCT01797965|144560820|SUPERIORITY|||||||0.7962|||||||ANCOVA|Based on ranks and adjusted for the baseline raw score, baseline age (\<=35 vs \>35) and history of prior IFN beta.||Change from Baseline 301 to Week 60 for 301||||0.7962
72515023|NCT01797965|144560820|SUPERIORITY|||||||0.8486|||||||ANCOVA|Based on ranks and adjusted for the baseline raw score, baseline age (\<=35 vs \>35) and history of prior IFN beta.||Change from Baseline 301 to Week 72 for 301||||0.8486
72515024|NCT01797965|144560820|SUPERIORITY|||||||0.4478|||||||ANCOVA|Based on ranks and adjusted for the baseline raw score, baseline age (\<=35 vs \>35) and history of prior IFN beta.||Change from Baseline 301 to Week 84 for 301||||0.4478
72515025|NCT01797965|144560820|SUPERIORITY|||||||0.325|||||||ANCOVA|Based on ranks and adjusted for the baseline raw score, baseline age (\<=35 vs \>35) and history of prior IFN beta.||Change from Baseline 301 to Week 96 for 301||||0.3250
72515026|NCT01797965|144560820|SUPERIORITY|||||||0.129|||||||ANCOVA|Based on ranks and adjusted for the baseline raw score, baseline age (\<=35 vs \>35) and history of prior IFN beta.||Change from Baseline 301 to Week 108 for 301||||0.1290
72515027|NCT01797965|144560820|SUPERIORITY|||||||0.7295|||||||ANCOVA|Based on ranks and adjusted for the baseline raw score, baseline age (\<=35 vs \>35) and history of prior IFN beta.||Change from Baseline 301 to Week 120 for 301||||0.7295
72515028|NCT01797965|144560820|SUPERIORITY|||||||0.8647|||||||ANCOVA|Based on ranks and adjusted for the baseline raw score, baseline age (\<=35 vs \>35) and history of prior IFN beta.||Change from Baseline 301 to Week 132 for 301||||0.8647
72515029|NCT01797965|144560820|SUPERIORITY|||||||0.2183|||||||ANCOVA|Based on ranks and adjusted for the baseline raw score, baseline age (\<=35 vs \>35) and history of prior IFN beta.||Change from Baseline 301 to Week 144 for 301||||0.2183
72515030|NCT01797965|144560820|SUPERIORITY|||||||0.3945|||||||ANCOVA|Based on ranks and adjusted for the baseline raw score, baseline age (\<=35 vs \>35) and history of prior IFN beta.||Change from Baseline 301 to Baseline 303||||0.3945
72515031|NCT01797965|144560820|SUPERIORITY|||||||0.5068|||||||ANCOVA|Based on ranks and adjusted for the baseline raw score, baseline age (\<=35 vs \>35) and history of prior IFN beta.||Change from Baseline 301 to Week 12 for 303||||0.5068
72515032|NCT01797965|144560820|SUPERIORITY|||||||0.1669|||||||ANCOVA|Based on ranks and adjusted for the baseline raw score, baseline age (\<=35 vs \>35) and history of prior IFN beta.||Change from Baseline 301 to Week 24 for 303||||0.1669
72515033|NCT01797965|144560820|SUPERIORITY|||||||0.5038|||||||ANCOVA|Based on ranks and adjusted for the baseline raw score, baseline age (\<=35 vs \>35) and history of prior IFN beta.||Change from Baseline 301 to Week 48 for 303||||0.5038
72515034|NCT01797965|144560820|SUPERIORITY|||||||0.6001|||||||ANCOVA|Based on ranks and adjusted for the baseline raw score, baseline age (\<=35 vs \>35) and history of prior IFN beta.||Change from Baseline 301 to Week 144 for 303||||0.6001
72515035|NCT01797965|144560820|SUPERIORITY|||||||0.8617|||||||ANCOVA|Based on ranks and adjusted for the baseline raw score, baseline age (\<=35 vs \>35) and history of prior IFN beta.||Change from Baseline 301 to Week 168 for 303||||0.8617
72515036|NCT01797965|144560820|SUPERIORITY|||||||0.259|||||||ANCOVA|Based on ranks and adjusted for the baseline raw score, baseline age (\<=35 vs \>35) and history of prior IFN beta.||Change from Baseline 301 to Week 192 for 303||||0.2590
72515037|NCT01797965|144560820|SUPERIORITY|||||||0.5159|||||||ANCOVA|Based on ranks and adjusted for the baseline raw score, baseline age (\<=35 vs \>35) and history of prior IFN beta.||Change from Baseline 301 to Week 216 for 303||||0.5159
72515038|NCT01797965|144560820|SUPERIORITY|||||||0.6123|||||||ANCOVA|Based on ranks and adjusted for the baseline raw score, baseline age (\<=35 vs \>35) and history of prior IFN beta.||Change from Baseline 301 to Week 240 for 303||||0.6123
72515039|NCT00441103|144560848|SUPERIORITY_OR_OTHER||||||<|0.001||||||Non-parametric analysis of variance (ANOVA) with effects for treatment and the absence/presence of Gd-enhancing lesions at baseline as factors|ANOVA|||||||<0.001
72515040|NCT00441103|144560849|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.67|STANDARD_DEVIATION|2.33|<|0.001|||||||Wilcoxon signed-rank test|||Mean difference was calculated by subtracting 'Day 1 up to Week 16' from 'Week 17 up to Week 40' and analyzed using Wilcoxon signed-rank test.||||<0.001
72488014|NCT00597753|144504713|NON_INFERIORITY_OR_EQUIVALENCE|A non-inferiority margin of -1.0 g/dL was used in the primary efficacy assessments. Non-inferiority was established if the lower limit of the two-sided 95% confidence interval for the difference between the means of the primary endpoint (peginesatide minus control ESA) was ≥ -1.0 g/dL.|Least Squares Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.072|||TWO_SIDED|95.0|-0.3|-0.01|||ANOVA|The ANOVA cell means model was used to estimate primary efficacy endpoint within the specified cells formed by the combination of treatment and strata||The sample size for this study was determined based on a two group evaluation of non-inferiority using the t-distribution (one-sided significance level 0.025) with a non inferiority margin of -1.0 g/dL. A sample size of approximately 750 (peginesatide group of 500 and epoetin alfa group of 250) provided at least 99% power for the evaluation of non-inferiority, assuming an expected treatment difference of 0.0 g/dL and a standard deviation of 1.5 g/dL.||-0.01|-0.30|
72488015|NCT00597753|144504714|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.21|||||TWO_SIDED|95.0|0.76|1.92|||Cochran-Mantel-Haenszel|||||1.92|0.76|
72488016|NCT00597753|144504715|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.88|||||TWO_SIDED|95.0|0.79|0.97|||Cochran-Mantel-Haenszel|||||0.97|0.79|
72488017|NCT03451851|144504716|SUPERIORITY||Difference in percentage|49.9|||<|0.001|TWO_SIDED|95.0|25.9|69.4|||Fisher Exact|P-values represented the comparisons with placebo and were based on the Fisher's exact test stratified by age group and region (pooled).||Guselkumab Vs Placebo||69.4|25.9|<0.001
72488018|NCT03451851|144504717|SUPERIORITY||Difference in percentage|55.6|||<|0.001|TWO_SIDED|95.0|32.1|74.0|||Fisher Exact|P-values represented the comparisons with placebo and were based on the Fisher's exact test stratified by age group and region (pooled).||Guselkumab Vs Placebo||74.0|32.1|<0.001
72488019|NCT03451851|144504718|SUPERIORITY||Difference in percentage|40.1|||=|0.003|TWO_SIDED|95.0|15.6|61.3|||Fisher Exact|P-values represented the comparisons with placebo and were based on the Fisher's exact test stratified by age group and region (pooled).||Guselkumab Vs Placebo||61.3|15.6|=0.003
72488020|NCT03451851|144504719|SUPERIORITY||Difference in percentage|35.0|||=|0.004|TWO_SIDED|95.0|10.5|56.8|||Fisher Exact|P-values represented the comparisons with placebo and were based on the Fisher's exact test stratified by age group and region (pooled).||Guselkumab Vs Placebo||56.8|10.5|=0.004
72488021|NCT03451851|144504720|SUPERIORITY||Difference in percentage|34.1|||=|0.002|TWO_SIDED|25.0|9.7|56.1|||Fisher Exact|P-values represented the comparisons with placebo and were based on the Fisher's exact test stratified by age group and region (pooled).||Guselkumab Vs Placebo||56.1|9.7|=0.002
72488022|NCT03451851|144504721|SUPERIORITY||LS Mean difference|-5.4|||<|0.001|TWO_SIDED|95.0|-7.33|-3.06|||Mixed model repeated measures (MMRM)|||Guselkumab Vs Placebo||-3.06|-7.33|<0.001
72488023|NCT03451851|144504727|SUPERIORITY||Difference in percentage|59.8|||<|0.001|TWO_SIDED|95.0|36.9|77.6||p-value is nominal|Fisher Exact|P-values represented the comparisons with placebo and were based on the Fisher's exact test stratified by age group and region (pooled).||Guselkumab Vs Placebo||77.6|36.9|<0.001
72488024|NCT03451851|144504735|SUPERIORITY||Difference in percentage|46.7|||=|0.002|TWO_SIDED|95.0|21.9|67.3||p-value is nominal|Fisher Exact|P-values represented the comparisons with placebo and were based on the Fisher's exact test stratified by age group and region (pooled).||||67.3|21.9|=0.002
72488025|NCT03451851|144504737|SUPERIORITY||Difference in Percentage|23.1|||=|0.139|TWO_SIDED|95.0|-3.4|47.0||p-value is nominal|Fisher Exact|P-values represented the comparisons with placebo and were based on the Fisher's exact test stratified by age group and region (pooled).||Guselkumab Vs Placebo||47.0|-3.4|=0.139
72488026|NCT03451851|144504739|SUPERIORITY||Difference in LS Mean|-5.44|||<|0.001|TWO_SIDED|95.0|-8.0|-2.87||p-value is nominal|MMRM model|||Guselkumab Vs Placebo||-2.87|-8.00|<0.001
72488027|NCT03451851|144504741|SUPERIORITY||LS Mean difference|-14.78|||<|0.001|TWO_SIDED|95.0|-20.28|-9.28||p-value is nominal|MMRM model|||Guselkumab Vs Placebo||-9.28|-20.28|<0.001
72488028|NCT05885737|144504751|EQUIVALENCE|Testing of primary efficacy endpoint was 2-sided and conducted at the 5% significance level. The efficacy of difelikefalin was to be declared for this study if null hypothesis of no treatment difference in the primary efficacy analysis was rejected in favor of the alternative that participants randomized to difelikefalin experience significantly different itching compared to participants randomized to placebo. The null hypothesis was to be rejected if the 2-sided p value was less than (\<) 0.05.|Least square mean difference|-0.81|STANDARD_ERROR_OF_MEAN|0.223||0.0003|TWO_SIDED|95.0|-1.25|-0.37|||MMRM|||The null hypothesis in this study was that there was no treatment difference in the primary efficacy analysis of the primary endpoint. The alternative hypothesis was that in participants randomized to difelikefalin there was a significant treatment difference in change in itching compared to participants randomized to placebo. The assessment was based on the mean change from baseline in the weekly mean of the daily 24-hour WI-NRS score at Week 4 of the DB period.||-0.37|-1.25|0.0003
72488029|NCT00736255|144504763|SUPERIORITY_OR_OTHER|||||||0.54|||||||Chi-squared|||"Null Hypothesis:LDX and NRT will not facilitate smoking cessation compared to NRT and placebo.~Alternate Hypothesis: LDX and NRT will facilitate smoking cessation compared to NRT and placebo.~This is a one tailed, proof of concept study so there is no formal power analysis, however if we see a signal for treatment effect, we would like to do further investigation by conducting a separate trial."||||0.54
72488030|NCT01469182|144504817|SUPERIORITY_OR_OTHER||Percent Difference|9.95||||0.005|TWO_SIDED|95.0|3.1|16.7|||Stratified Miettinen and Nurminen|Baseline asthmatic status as the factor||||16.7|3.1|0.005
72488031|NCT01469182|144504818|SUPERIORITY_OR_OTHER||Percent Difference|5.58|||<|0.001|TWO_SIDED|95.0|2.9|8.2|||Stratified Miettinen and Nurminen|Baseline asthmatic status as the factor||||8.2|2.9|<0.001
72488032|NCT01469182|144504819|SUPERIORITY_OR_OTHER||Percent Difference|7.88|||<|0.001|TWO_SIDED|95.0|5.5|10.5|||Stratified Miettinen and Nurminen|Baseline asthmatic status as the factor||||10.5|5.5|<0.001
72488033|NCT01469182|144504820|SUPERIORITY_OR_OTHER||Percent Difference|10.17|||<|0.001|TWO_SIDED|95.0|6.6|13.6|||Stratified Miettinen and Nurminen|Baseline asthmatic status as the factor||||13.6|6.6|<0.001
72488034|NCT01469182|144504821|SUPERIORITY_OR_OTHER||Percent Difference|5.25|||<|0.001|TWO_SIDED|95.0|3.3|7.4|||Stratified Miettinen and Nurminen|Baseline asthmatic status as the factor||||7.4|3.3|<0.001
72488035|NCT01469182|144504822|SUPERIORITY_OR_OTHER||Percent Difference|0.17||||0.861|TWO_SIDED|95.0|-2.1|1.9|||Stratified Miettinen and Nurminen|Baseline asthmatic status as the factor||||1.9|-2.1|0.861
72568152|NCT00251719|144667867|NON_INFERIORITY_OR_EQUIVALENCE|If the lower bound of the 95% CI was greater than -10%, noninferiority was concluded. Superiority of primary efficacy endpoint was assessed by comparing the crude healing rate of dexlansoprazole MR 60 mg dose to that of lansoprazole 30 mg using a Cochran Mantel Haenszel (CMH) test with baseline LA EE Grade as strata.|Difference in percentage|2.34||||0.234||95.0|-1.45|6.14||Unadjusted p-value is presented. The overall 0.05 level of significance for the multiple comparisons of each dexlansoprazole dose to lansoprazole was controlled using Hochberg's method.|Cochran-Mantel-Haenszel|||||6.14|-1.45|0.234
72568153|NCT00251719|144667867|NON_INFERIORITY_OR_EQUIVALENCE|If the lower bound of the 95% CI was greater than -10%, noninferiority was concluded. Superiority of primary efficacy endpoint was assessed by comparing the crude healing rate of dexlansoprazole MR 90 mg dose to that of lansoprazole 30 mg using a Cochran Mantel Haenszel (CMH) test with baseline LA EE Grade as strata.|Difference in percentage|4.85||||0.019||95.0|1.2|8.5||Unadjusted p-value is presented. The overall 0.05 level of significance for the multiple comparisons of each dexlansoprazole dose to lansoprazole was controlled using Hochberg's method.|Cochran-Mantel-Haenszel|||||8.50|1.20|0.019
72568154|NCT00251719|144667867|SUPERIORITY_OR_OTHER|||||||0.22||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Cochran-Mantel-Haenszel|||||||0.220
72403491|NCT00851799|144312763|SUPERIORITY_OR_OTHER||Difference in Change (%)|-0.21||||0.53|TWO_SIDED|97.5|-0.98|0.55||Inference was assessed against a type I error of 2.5% to account for multiple comparisons.|Regression, Linear||The difference in change in relative FMD (Cohort B - Cohort A and C); estimated by linear regression that adjusted for study entry BA diameter and screening HIV-1 RNA level and Framingham risk score stratification factors.|The study was designed to compare change from study entry to week 24 in brachial artery (BA) flow mediated dilation (FMD) between a RTV-boosted protease inhibitor-containing regimen (the pooled ATV/RTV and DRV/RTV groups) and a RAL-containing regimen. However, in the event of a significant difference between ATV/RTV and DRV/RTV groups, the study was designed to make all pairwise treatment group comparisons.||0.55|-0.98|0.53
72403492|NCT02121483|144312903|SUPERIORITY_OR_OTHER||Slope|0.949|STANDARD_ERROR_OF_MEAN|0.1075|||TWO_SIDED|95.0|0.7276|1.1704|||||Dose proportionality was assessed based on a power model that describes the functional relationship between the dose and AUC0-inf. Based on the estimate for the slope parameter β, a 2-sided 95% confidence interval (CI) for the slope was computed.|||1.1704|0.7276|
72403493|NCT02121483|144312904|SUPERIORITY_OR_OTHER||Slope|0.9597|STANDARD_ERROR_OF_MEAN|0.1088|||TWO_SIDED|95.0|0.7356|1.1838|||||Dose proportionality was assessed based on a power model that describes the functional relationship between the dose and AUC0-tz. Based on the estimate for the slope parameter β, a 2-sided 95% CI for the slope was computed.|||1.1838|0.7356|
72568155|NCT00251719|144667868|SUPERIORITY_OR_OTHER|||||||0.768||95.0||||Unadjusted p-value is presented. Statistical significance was determined at 0.05 level by Hommel-Simes method within treatment and Hochberg method for comparisons of each dexlansoprazole dose to lansoprazole.|Cochran-Mantel-Haenszel|||||||0.768
72403494|NCT02121483|144312905|SUPERIORITY_OR_OTHER||Slope|0.8554|STANDARD_ERROR_OF_MEAN|0.1481|||TWO_SIDED|95.0|0.5504|1.1603|||||Dose proportionality was assessed based on a power model that describes the functional relationship between the dose and Cmax. Based on the estimate for the slope parameter β, a 2-sided 95% CI for the slope was computed.|||1.1603|0.5504|
72403495|NCT01420289|144312911|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.0|STANDARD_ERROR_OF_MEAN|15.0||0.086|TWO_SIDED|95.0|10.0|80.0|||t-test, 2 sided|||||80|10|0.086
72403496|NCT01420289|144312912|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|30.0|STANDARD_ERROR_OF_MEAN|11.0|<|0.05|TWO_SIDED|95.0|10.0|100.0|||t-test, 2 sided|||||100|10|<0.05
72568156|NCT00251719|144667868|SUPERIORITY_OR_OTHER|||||||0.064||95.0||||Unadjusted p-value is presented. Statistical significance was determined at 0.05 level by Hommel-Simes method within treatment and Hochberg method for comparisons of each dexlansoprazole dose to lansoprazole.|Cochran-Mantel-Haenszel|||||||0.064
72568157|NCT00251719|144667868|SUPERIORITY_OR_OTHER|||||||0.034||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Cochran-Mantel-Haenszel|||||||0.034
72403497|NCT02932904|144312917|SUPERIORITY||Least square (LS) Mean Difference|2.74|STANDARD_ERROR_OF_MEAN|1.04||0.009|TWO_SIDED|95.0|0.69|4.78||The comparisons were between each vortioxetine dose (10 or 20 mg) and paroxetine, and the Holm-Bonferroni method was used to adjust for multiplicity and control the familywise type I error rate at a significance level of 0.05.|ANCOVA with LOCF|||ANCOVA with last observation carried forward (LOCF) model was used for p-value with treatment, pooled center, and gender as fixed factors and with baseline CSFQ-14 total score as a covariate.||4.78|0.69|0.009
72488036|NCT01469182|144504823|SUPERIORITY_OR_OTHER||Percent Difference|1.15||||0.344||95.0|-1.5|3.3|||Stratified Miettinen and Nurminen|Baseline asthmatic status as the factor||||3.3|-1.5|0.344
72515041|NCT00239837|144560861|SUPERIORITY_OR_OTHER_LEGACY||Wald χ2|7.14||||0.008|TWO_SIDED||||||Regression, Logistic|Data analyzed using repeated logistic regression model (generalized estimating equations). Domain X EV Level X Group interaction tested.|We began the analyses with a full-factorial model regressing choice on domain (gain=1, loss=0), the EV of the risky choice relative to the safe option (EV; range = -.38 to +.38), and dummy-coded treatment groups (Control= -1, Intervention =1).|||||.008
72488037|NCT01469182|144504824|SUPERIORITY_OR_OTHER||Percent Difference|0.99||||0.382|TWO_SIDED|95.0|-1.5|3.0|||Stratified Miettinen and Nurminen|Baseline asthmatic status as the factor||||3.0|-1.5|0.382
72488038|NCT01469182|144504825|SUPERIORITY_OR_OTHER||Percent Difference|2.46||||0.029|TWO_SIDED|95.0|0.3|4.4|||Stratified Miettinen and Nurminen|Baseline asthmatic status as the factor||||4.4|0.3|0.029
72488039|NCT02114164|144504826|OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
72488040|NCT02114164|144504827|OTHER|||||||0.39|||||||t-test, 2 sided|||||||0.39
72488041|NCT02114164|144504828|OTHER|||||||0.13||||||Comparison at baseline|t-test, 2 sided|||||||0.13
72488042|NCT02114164|144504828|OTHER|||||||0.018||||||Comparison at 60 minutes|t-test, 2 sided|||||||0.018
72488043|NCT02114164|144504828|OTHER|||||||0.712||||||Comparison at end of procedure|t-test, 2 sided|||||||0.712
72488044|NCT02114164|144504829|OTHER|||||||0.42||||||Comparison at baseline|t-test, 2 sided|||||||0.42
72488045|NCT02114164|144504829|OTHER|||||||0.75||||||Comparison at 60 minutes|t-test, 2 sided|||||||0.75
72488046|NCT02114164|144504829|OTHER|||||||0.99||||||Comparison at end of procedure|t-test, 2 sided|||||||0.99
72488047|NCT02114164|144504830|OTHER|||||||0.88||||||Comparison at baseline|t-test, 2 sided|||||||0.88
72488048|NCT02114164|144504830|OTHER|||||||0.65||||||Comparison at 60 minutes|t-test, 2 sided|||||||0.65
72488049|NCT02114164|144504830|OTHER|||||||0.86||||||Comparison at end of procedure|t-test, 2 sided|||||||0.86
72488050|NCT02114164|144504831|OTHER|Number of interventions required by the anesthesiologists were compared between the AirSeal and standard Endopath groups using zero-inflated Poisson regression||||||0.41|||||||Zero-inflated Poisson regression|||||||0.41
72488051|NCT02114164|144504832|OTHER|||||||0.09|||||||t-test, 2 sided|||||||0.09
72488052|NCT02114164|144504833|OTHER||||||<|0.001|||||||Chi-squared|||||||<0.001
72488053|NCT02687542|144504834|OTHER|Bayesian Dose Response Analysis|Bayesian Dose Reponse Estimate|-0.693|STANDARD_ERROR_OF_MEAN|0.6162||0.5776|TWO_SIDED|90.0|-1.713|0.304||Bayesian Predictive Test for Emax (the additive increase over Placebo in the response of PF-06649751 at a theoretically infinite dose) Monotonicity|Bayesian Dose Response Analysis|Estimate and 90% credible interval of Bayesian dose response difference from placebo||||0.304|-1.713|0.5776
72488054|NCT00111800|144504920|SUPERIORITY||Mean Difference (Net)|-0.28||||0.061|TWO_SIDED|95.0|-0.58|0.01|||ANCOVA||The point estimate was calculated as least square mean difference (net values) of placebo and DEN 2.5 mg.|A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||0.01|-0.58|0.061
72488055|NCT00111800|144504920|SUPERIORITY||Mean Difference (Net)|-0.53|||<|0.001|TWO_SIDED|95.0|-0.82|-0.24|||ANCOVA||The point estimate was calculated as least square mean difference (net values) of placebo and DEN 7.5 mg.|A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||-0.24|-0.82|<0.001
72488056|NCT00111800|144504920|SUPERIORITY||Mean Difference (Net)|-0.45||||0.002|TWO_SIDED|95.0|-0.74|-0.16|||ANCOVA||The point estimate was calculated as least square mean difference (net values) of placebo and DEN 15 mg.|A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||-0.16|-0.74|0.002
72488057|NCT00111800|144504920|SUPERIORITY||Mean Difference (Net)|-0.8|||<|0.001|TWO_SIDED|95.0|-1.09|-0.5|||ANCOVA||The point estimate was calculated as least square mean difference (net values) of placebo and DEN 30 mg.|A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||-0.50|-1.09|<0.001
72488058|NCT00111800|144504920|SUPERIORITY||Mean Difference (Net)|-0.84|||<|0.001|TWO_SIDED|95.0|-1.13|-0.55|||ANCOVA||The point estimate was calculated as least square mean difference (net values) of placebo and DEN 45 mg.|A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||-0.55|-1.13|<0.001
72488059|NCT00111800|144504922|SUPERIORITY||Mean Difference (Net)|-0.4||||0.306|TWO_SIDED|95.0|-1.18|0.37|||ANCOVA||The point estimate was calculated as least square mean difference (net values) of placebo and DEN 2.5 mg.|A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||0.37|-1.18|0.306
72488060|NCT00111800|144504922|SUPERIORITY||Mean Difference (Net)|-0.8||||0.039|TWO_SIDED|95.0|-1.56|-0.04|||ANCOVA||The point estimate was calculated as least square mean difference (net values) of placebo and DEN 7.5 mg.|A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||-0.04|-1.56|0.039
72568158|NCT00251719|144667869|SUPERIORITY_OR_OTHER|||||||0.727||95.0||||Unadjusted p-value is presented. Statistical significance was determined at 0.05 level by Hommel-Simes method within treatment and Hochberg method for comparisons of each dexlansoprazole dose to lansoprazole.|Log Rank|||||||0.727
72568159|NCT00251719|144667869|SUPERIORITY_OR_OTHER|||||||0.064||95.0||||Unadjusted p-value is presented. Statistical significance was determined at 0.05 level by Hommel-Simes method within treatment and Hochberg method for comparisons of each dexlansoprazole dose to lansoprazole.|Log Rank|||||||0.064
72568160|NCT00251719|144667869|SUPERIORITY_OR_OTHER|||||||0.174||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Log Rank|||||||0.174
72568161|NCT00251719|144667870|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was supported if the lower bound of the 95% CI for the difference with lansoprazole 30 mg of the estimated 8-week healing rate was greater than -10%. Superiority was assessed based on log-rank tests comparing treatments for the endpoints.|Difference in percentage|1.65||||0.167||95.0|-1.65|4.96||Unadjusted p-value is presented. The overall 0.05 level of significance for the multiple comparisons of each dexlansoprazole dose to lansoprazole was controlled using Hochberg's method.|Log Rank|||||4.96|-1.65|0.167
72403498|NCT02932904|144312917|SUPERIORITY||LS Mean Difference|1.05|STANDARD_ERROR_OF_MEAN|1.017||0.303|TWO_SIDED|95.0|-0.95|3.05||The comparisons were between each vortioxetine dose (10 or 20 mg) and paroxetine, and the Holm-Bonferroni method was used to adjust for multiplicity and control the familywise type I error rate at a significance level of 0.05.|ANCOVA with LOCF|||ANCOVA model with the LOCF method was used for p-value with treatment, pooled center, and gender as fixed factors and with baseline CSFQ-14 total score as a covariate.||3.05|-0.95|0.303
72515042|NCT00302718|144560924|OTHER||||||<|0.0001|||||||Chi-squared|||||||<.0001
72515043|NCT00302718|144560926|OTHER|||||||0.2114|||||||Chi-squared|||||||0.2114
72568162|NCT00251719|144667870|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was supported if the lower bound of the 95% CI for the difference with lansoprazole 30 mg of the estimated 8-week healing rate was greater than -10%. Superiority was assessed based on log-rank tests comparing treatments for the endpoints.|Difference in percentage|3.39||||0.03||95.0|0.27|6.5||Unadjusted p-value is presented. The overall 0.05 level of significance for the multiple comparisons of each dexlansoprazole dose to lansoprazole was controlled using Hochberg's method.|Log Rank|||||6.50|0.27|0.030
72515044|NCT00302718|144560928|OTHER|||||||0.6954|||||||Chi-squared|||||||0.6954
72515045|NCT00302718|144560930|OTHER|||||||0.9895|||||||Chi-squared|||||||0.9895
72515046|NCT00738374|144560943|SUPERIORITY_OR_OTHER|||||||0.0008|TWO_SIDED||||||Chi-squared|||Analysis compared responders and non-responders.||||0.0008
72515047|NCT00738374|144560944|SUPERIORITY_OR_OTHER|||||||0.0795|TWO_SIDED||||||Chi-squared|||||||0.0795
72515048|NCT00738374|144560960|SUPERIORITY_OR_OTHER|||||||0.2712|TWO_SIDED||||||Log Rank|||||||0.2712
72568163|NCT00251719|144667870|SUPERIORITY_OR_OTHER|||||||0.413||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Log Rank|||||||0.413
72568164|NCT00251719|144667871|SUPERIORITY_OR_OTHER|||||||0.1||95.0||||Unadjusted p-value is presented. Statistical significance was determined at 0.05 level by Hommel-Simes method within treatment and Hochberg method for comparisons of each dexlansoprazole dose to lansoprazole.|Cochran-Mantel-Haenszel|||||||0.100
72515049|NCT03334396|144560963|SUPERIORITY||Odds Ratio (OR)|2.61||||0.02|TWO_SIDED|95.0|1.17|5.84|||Regression, Logistic|||||5.84|1.17|0.020
72515050|NCT03334396|144560963|SUPERIORITY||Odds Ratio (OR)|4.1|||<|0.001|TWO_SIDED|95.0|1.93|8.7|||Regression, Logistic|||||8.70|1.93|<0.001
72515051|NCT03334396|144560964|SUPERIORITY||Odds Ratio (OR)|2.72||||0.014|TWO_SIDED|95.0|1.23|6.01|||Regression, Logistic|||||6.01|1.23|0.014
72515052|NCT03334396|144560965|SUPERIORITY||Odds Ratio (OR)|2.03||||0.032|TWO_SIDED|95.0|1.06|3.88|||Regression, Logistic|||||3.88|1.06|0.032
72515053|NCT03334396|144560965|SUPERIORITY||Odds Ratio (OR)|2.46||||0.006|TWO_SIDED|95.0|1.29|4.67|||Regression, Logistic|||||4.67|1.29|0.006
72515054|NCT03334396|144560965|SUPERIORITY||Odds Ratio (OR)|3.72|||<|0.001|TWO_SIDED|95.0|2.01|6.89|||Regression, Logistic|||||6.89|2.01|<0.001
72568165|NCT00251719|144667871|SUPERIORITY_OR_OTHER|||||||0.125||95.0||||Unadjusted p-value is presented. Statistical significance was determined at 0.05 level by Hommel-Simes method within treatment and Hochberg method for comparisons of each dexlansoprazole dose to lansoprazole.|Cochran-Mantel-Haenszel|||||||0.125
72515055|NCT03334396|144560966|SUPERIORITY||Odds Ratio (OR)|1.73||||0.21|TWO_SIDED|95.0|0.74|4.05|||Regression, Logistic|||||4.05|0.74|0.210
72515056|NCT03334396|144560966|SUPERIORITY||Odds Ratio (OR)|2.5||||0.029|TWO_SIDED|95.0|1.1|5.7|||Regression, Logistic|||||5.70|1.10|0.029
72515057|NCT03334396|144560966|SUPERIORITY||Odds Ratio (OR)|4.13|||<|0.001|TWO_SIDED|95.0|1.91|8.91|||Regression, Logistic|||||8.91|1.91|<0.001
72515058|NCT03334396|144560967|SUPERIORITY||Mean Difference (Final Values)|-13.4|STANDARD_ERROR_OF_MEAN|5.78||0.021|TWO_SIDED|95.0|-24.77|-2.03|||Mixed Models Analysis|||||-2.03|-24.77|0.021
72515059|NCT03334396|144560967|SUPERIORITY||Mean Difference (Final Values)|-17.07|STANDARD_ERROR_OF_MEAN|5.57||0.002|TWO_SIDED|95.0|-28.05|-6.1|||Mixed Models Analysis|||||-6.10|-28.05|0.002
72515060|NCT03334396|144560967|SUPERIORITY||Mean Difference (Final Values)|-24.54|STANDARD_ERROR_OF_MEAN|5.23|<|0.001|TWO_SIDED|95.0|-34.84|-14.24|||Mixed Models Analysis|||||-14.24|-34.84|<0.001
72515061|NCT03334396|144560968|SUPERIORITY||Odds Ratio (OR)|4.28||||0.025|TWO_SIDED|95.0|1.2|15.24|||Regression, Logistic|||||15.24|1.20|0.025
72515062|NCT03334396|144560968|SUPERIORITY||Odds Ratio (OR)|6.14||||0.004|TWO_SIDED|95.0|1.79|20.99|||Regression, Logistic|||||20.99|1.79|0.004
72515063|NCT03334396|144560968|SUPERIORITY||Odds Ratio (OR)|8.76|||<|0.001|TWO_SIDED|95.0|2.68|28.58|||Regression, Logistic|||||28.58|2.68|<0.001
72515064|NCT03334396|144560969|SUPERIORITY||Odds Ratio (OR)|1.6||||0.246|TWO_SIDED|95.0|0.72|3.56|||Regression, Logistic|||||3.56|0.72|0.246
72515065|NCT03334396|144560969|SUPERIORITY||Odds Ratio (OR)|1.73||||0.169|TWO_SIDED|95.0|0.79|3.77|||Regression, Logistic|||||3.77|0.79|0.169
72403499|NCT02932904|144312918|SUPERIORITY||LS Mean Difference|1.13|STANDARD_ERROR_OF_MEAN|0.627||0.072|TWO_SIDED|95.0|-0.1|2.37|||ANCOVA with LOCF|||Week 1, ANCOVA model with the LOCF method was used for p-value with treatment, pooled center, and gender as fixed factors and with baseline CSFQ-14 total score as a covariate.||2.37|-0.10|0.072
72515066|NCT03334396|144560969|SUPERIORITY||Odds Ratio (OR)|3.62|||<|0.001|TWO_SIDED|95.0|1.82|7.18|||Regression, Logistic|||||7.18|1.82|<0.001
72515067|NCT03334396|144560970|SUPERIORITY||Mean Difference (Final Values)|-0.37||||0.103|TWO_SIDED|95.0|-0.82|0.08|||Mixed Models Analysis|||||0.08|-0.82|0.103
72515068|NCT03334396|144560970|SUPERIORITY||Mean Difference (Final Values)|-0.21||||0.352|TWO_SIDED|95.0|-0.65|0.23|||Mixed Models Analysis|||||0.23|-0.65|0.352
72515069|NCT03334396|144560970|SUPERIORITY||Mean Difference (Final Values)|-0.58||||0.006|TWO_SIDED|95.0|-1.0|-0.17|||Mixed Models Analysis|||||-0.17|-1.00|0.006
72568166|NCT00251719|144667871|SUPERIORITY_OR_OTHER|||||||0.993||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Cochran-Mantel-Haenszel|||||||0.993
72403500|NCT02932904|144312918|SUPERIORITY||LS Mean Difference|1.29|STANDARD_ERROR_OF_MEAN|0.612||0.035|TWO_SIDED|95.0|0.09|2.5|||ANCOVA with LOCF|||Week 1, ANCOVA model with the LOCF method was used for p-value with treatment, pooled center, and gender as fixed factors and with baseline CSFQ-14 total score as a covariate.||2.50|0.09|0.035
72403501|NCT02932904|144312918|SUPERIORITY||LS Mean Difference|1.22|STANDARD_ERROR_OF_MEAN|0.846||0.149|TWO_SIDED|95.0|-0.44|2.89|||ANCOVA with LOCF|||Week 2, ANCOVA model with the LOCF method was used for p-value with treatment, pooled center, and gender as fixed factors and with baseline CSFQ-14 total score as a covariate.||2.89|-0.44|0.149
72403502|NCT02932904|144312918|SUPERIORITY||LS Mean Difference|0.85|STANDARD_ERROR_OF_MEAN|0.828||0.303|TWO_SIDED|95.0|-0.78|2.48|||ANCOVA with LOCF|||Week 2, ANCOVA model with the LOCF method was used for p-value with treatment, pooled center, and gender as fixed factors and with baseline CSFQ-14 total score as a covariate.||2.48|-0.78|0.303
72403503|NCT02932904|144312918|SUPERIORITY||LS Mean Difference|2.0|STANDARD_ERROR_OF_MEAN|0.906||0.028|TWO_SIDED|95.0|0.22|3.78|||ANCOVA with LOCF|||Week 3, ANCOVA model with the LOCF method was used for p-value with treatment, pooled center, and gender as fixed factors and with baseline CSFQ-14 total score as a covariate.||3.78|0.22|0.028
72403504|NCT02932904|144312918|SUPERIORITY||LS Mean Difference|0.41|STANDARD_ERROR_OF_MEAN|0.886||0.645|TWO_SIDED|95.0|-1.33|2.15|||ANCOVA with LOCF|||Week 3, ANCOVA model with the LOCF method was used for p-value with treatment, pooled center, and gender as fixed factors and with baseline CSFQ-14 total score as a covariate.||2.15|-1.33|0.645
72515070|NCT03334396|144560971|SUPERIORITY||Mean Difference (Final Values)|-1.08||||0.005|TWO_SIDED|95.0|-1.84|-0.32|||Mixed Models Analysis|||||-0.32|-1.84|0.005
72515071|NCT03334396|144560971|SUPERIORITY||Mean Difference (Final Values)|-0.74||||0.051|TWO_SIDED|95.0|-1.48|0.0|||Mixed Models Analysis|||||0.00|-1.48|0.051
72515072|NCT03334396|144560971|SUPERIORITY||Mean Difference (Final Values)|-1.09||||0.002|TWO_SIDED|95.0|-1.79|-0.39|||Mixed Models Analysis|||||-0.39|-1.79|0.002
72515073|NCT03334396|144560972|SUPERIORITY||Odds Ratio (OR)|1.9||||0.019|TWO_SIDED|95.0|1.11|3.25|||Regression, Logistic|||||3.25|1.11|0.019
72515074|NCT03334396|144560972|SUPERIORITY||Mean Difference (Final Values)|2.44|||<|0.001|TWO_SIDED|95.0|1.44|4.14|||Regression, Logistic|||||4.14|1.44|<0.001
72515075|NCT03334396|144560972|SUPERIORITY||Mean Difference (Final Values)|4.18|||<|0.001|TWO_SIDED|95.0|2.51|6.96|||Regression, Logistic|||||6.96|2.51|<0.001
72515076|NCT03334396|144560973|SUPERIORITY||Odds Ratio (OR)|1.98||||0.424|TWO_SIDED|95.0|0.37|10.63|||Regression, Logistic|||||10.63|0.37|0.424
72515077|NCT03334396|144560973|SUPERIORITY||Odds Ratio (OR)|2.89||||0.182|TWO_SIDED|95.0|0.61|13.75|||Regression, Logistic|||||13.75|0.61|0.182
72568167|NCT00251719|144667872|SUPERIORITY_OR_OTHER|||||||0.117||95.0||||Unadjusted p-value is presented. Statistical significance was determined at 0.05 level by Hommel-Simes method within treatment and Hochberg method for comparisons of each dexlansoprazole dose to lansoprazole.|Log Rank|||||||0.117
72568168|NCT00251719|144667872|SUPERIORITY_OR_OTHER|||||||0.124||95.0||||Unadjusted p-value is presented. Statistical significance was determined at 0.05 level by Hommel-Simes method within treatment and Hochberg method for comparisons of each dexlansoprazole dose to lansoprazole.|Log Rank|||||||0.124
72568169|NCT00251719|144667872|SUPERIORITY_OR_OTHER|||||||0.949||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Log Rank|||||||0.949
72568170|NCT02408068|144667885|SUPERIORITY_OR_OTHER_LEGACY||Geometric LSmean ratio|77.56|||||TWO_SIDED|90.0|70.89|84.86|||ANOVA|||Results obtained using a mixed effects ANOVA with fixed effects for study period, sequence, treatment and subject (sequence) (excl. tmax).||84.86|70.89|
72568171|NCT02408068|144667886|SUPERIORITY_OR_OTHER_LEGACY||Geometric LSmean ratio|108.33|||||TWO_SIDED|90.0|102.3|114.72|||ANOVA|||||114.72|102.30|
72568172|NCT02408068|144667887|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|2.25||||0.0005|TWO_SIDED|95.0|1.25|3.75|||Wilcoxon (Mann-Whitney)|||||3.75|1.25|0.0005
72568173|NCT02408068|144667888|SUPERIORITY_OR_OTHER_LEGACY||Geometric LSmean ratio|83.27|||||TWO_SIDED|90.0|75.58|91.74||||||||91.74|75.58|
72568174|NCT02408068|144667889|SUPERIORITY_OR_OTHER_LEGACY||Geometric LSmean ratio|118.83|||||TWO_SIDED|90.0|111.58|126.54||||||||126.54|111.58|
72568175|NCT02408068|144667890|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|3.5||||0.0014|TWO_SIDED|95.0|2.25|4.38|||Wilcoxon (Mann-Whitney)|||||4.38|2.25|0.0014
72403505|NCT02932904|144312918|SUPERIORITY||LS Mean Difference|1.91|STANDARD_ERROR_OF_MEAN|0.943||0.043|TWO_SIDED|95.0|0.06|3.77|||ANCOVA with LOCF|||Week 4, ANCOVA model with the LOCF method was used for p-value with treatment, pooled center, and gender as fixed factors and with baseline CSFQ-14 total score as a covariate.||3.77|0.06|0.043
72403506|NCT02932904|144312918|SUPERIORITY||LS Mean Difference|0.68|STANDARD_ERROR_OF_MEAN|0.923||0.465|TWO_SIDED|95.0|-1.14|2.49|||ANCOVA with LOCF|||Week 4, ANCOVA model with the LOCF method was used for p-value with treatment, pooled center, and gender as fixed factors and with baseline CSFQ-14 total score as a covariate.||2.49|-1.14|0.465
72403507|NCT02932904|144312919|SUPERIORITY||LS Mean Difference|-1.63|STANDARD_ERROR_OF_MEAN|0.616||0.009|TWO_SIDED|95.0|-2.84|-0.41|||ANCOVA with LOCF|||Week 1, ANCOVA model with the LOCF method was used for p-value with treatment, pooled center, and gender as fixed factors and with baseline CSFQ-14 total score as a covariate.||-0.41|-2.84|0.009
72403508|NCT02932904|144312919|SUPERIORITY||LS Mean Difference|-1.29|STANDARD_ERROR_OF_MEAN|0.834||0.123|TWO_SIDED|95.0|-2.93|0.35|||ANCOVA with LOCF|||Week 2, ANCOVA model with the LOCF method was used for p-value with treatment, pooled center, and gender as fixed factors and with baseline CSFQ-14 total score as a covariate.||0.35|-2.93|0.123
72568176|NCT02623348|144667901|SUPERIORITY||||||<|0.01||||||Threshold for significance: \<0.05|linear mixed modeling|||||||<0.01
72568177|NCT02701413|144667918|OTHER|||||||0.04|||||||Wilcoxon (Mann-Whitney)|||||||0.04
72568178|NCT02701413|144667922|OTHER|||||||0.88|||||||Wilcoxon (Mann-Whitney)|||||||0.88
72568179|NCT00472797|144667923|SUPERIORITY_OR_OTHER||mean|2.73|||<|0.001||97.5|2.73|2.73||P-Value denotes percent change from baseline to week 12 for all combined subjects.|t-test, 1 sided|||A one-sided paired t-test across all subjects by combining the titrated and non-titrated new formulation groups was performed.||2.73|2.73|<0.001
72568180|NCT00472797|144667924|SUPERIORITY_OR_OTHER|||||||0.466||||||P-value denotes difference between treatment groups|ANOVA|||||||0.466
72568181|NCT00472797|144667924|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value denotes the mean percent change from baseline to week 12.|t-test, 1 sided|||||||<0.001
72568182|NCT00472797|144667924|SUPERIORITY_OR_OTHER|||||||0.003||95.0||||P-value denotes the mean percent change from baseline to week 12.|t-test, 1 sided|||||||0.003
72403509|NCT02932904|144312919|SUPERIORITY||LS Mean Difference|-1.85|STANDARD_ERROR_OF_MEAN|0.892||0.039|TWO_SIDED|95.0|-3.61|-0.1|||ANCOVA with LOCF|||Week 3, ANCOVA model with the LOCF method was used for p-value with treatment, pooled center, and gender as fixed factors and with baseline CSFQ-14 total score as a covariate.||-0.10|-3.61|0.039
72403510|NCT02932904|144312919|SUPERIORITY||LS Mean Difference|-2.49|STANDARD_ERROR_OF_MEAN|0.929||0.008|TWO_SIDED|95.0|-4.32|-0.66|||ANCOVA with LOCF|||Week 4, ANCOVA model with the LOCF method was used for p-value with treatment, pooled center, and gender as fixed factors and with baseline CSFQ-14 total score as a covariate.||-0.66|-4.32|0.008
72568183|NCT00472797|144667925|SUPERIORITY_OR_OTHER||||||<|0.001||||||P-value refers to change in total score from baseline to week 12 for all domains, except global side effect score, in the MSTCQ for all subjects combined.|t-test, 1 sided|Paired t-test for change from baseline to week 12||Change in total score from baseline to week 12 for all subjects combined. Lower scores indicate a more favorable response||||<0.001
72568184|NCT00472797|144667925|SUPERIORITY_OR_OTHER|||||||0.11||95.0||||P-value refers to differences between treatment groups in change in total score from baseline to week 12 for all domains, except global side effect score, in the MSTCQ.|ANOVA|||Analysis evaluated differences between treatment groups in change in total score from baseline to week 12 for all domains, except global side effect score, in the MSTCQ. Lower scores indicate a more favorable response.||||0.110
72568185|NCT00472797|144667926|SUPERIORITY_OR_OTHER|||||||0.302||95.0||||P-value refers to differneces in total score from baseline to week 12 between treatment groups.|ANOVA|||Analysis evaluates total score from baseline to week 12 for differences between each treatment group.||||0.302
72568186|NCT00472797|144667928|SUPERIORITY_OR_OTHER|||||||0.899||95.0||||P-value denotes differences between treatment groups in change in diameter of injection site redness from baseline to week 12.|ANOVA|||Analysis evaluates differences between treatment groups in change in diameter of injection site redness from baseline to week 12.||||0.899
72568187|NCT00472797|144667929|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|Paired||Physical Component - Change from Baseline to Week 12||||<0.001
72568188|NCT00472797|144667929|SUPERIORITY_OR_OTHER|||||||0.234||95.0|||||t-test, 2 sided|Paired||Physical Component - Change from Baseline to Week 36||||0.234
72568189|NCT00472797|144667929|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||t-test, 2 sided|Paired||Physical Component - Change from Baseline to Extension Visit 1||||0.001
72568190|NCT00472797|144667929|SUPERIORITY_OR_OTHER|||||||0.004||95.0|||||t-test, 2 sided|Paired||Physical Component - Change from Baseline to Extension Visit 3||||0.004
72403511|NCT02932904|144312919|SUPERIORITY||LS Mean Difference|-2.77|STANDARD_ERROR_OF_MEAN|1.024||0.007|TWO_SIDED|95.0|-4.78|-0.75|||ANCOVA with LOCF|||Week 5, ANCOVA model with the LOCF method was used for p-value with treatment, pooled center, and gender as fixed factors and with baseline CSFQ-14 total score as a covariate.||-0.75|-4.78|0.007
72403512|NCT02932904|144312920|SUPERIORITY||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.612||0.419|TWO_SIDED|95.0|-1.7|0.71|||ANCOVA with LOCF|||Week 1, ANCOVA model with the LOCF method was used for p-value with treatment, pooled center, and gender as fixed factors and with baseline CSFQ-14 total score as a covariate.||0.71|-1.70|0.419
72568191|NCT00472797|144667929|SUPERIORITY_OR_OTHER|||||||0.036||95.0|||||t-test, 2 sided|Paired||Physical Component - Change from Baseline to Exisit Visit LOCF||||0.036
72568192|NCT00472797|144667929|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||t-test, 2 sided|Paired||Mental Component - Baseline to Week 12||||0.002
72568193|NCT00472797|144667929|SUPERIORITY_OR_OTHER|||||||0.468||95.0|||||t-test, 2 sided|Paired||Mental Component - Baseline to Week 36||||0.468
72568194|NCT00472797|144667929|SUPERIORITY_OR_OTHER|||||||0.602||95.0|||||t-test, 2 sided|Paired||Mental Component - Change from Baseline to Extension Visit 1||||0.602
72568195|NCT00472797|144667929|SUPERIORITY_OR_OTHER|||||||0.414||95.0|||||t-test, 2 sided|Paired||Change from Baseline to Extension Visit 3||||0.414
72568196|NCT00472797|144667929|SUPERIORITY_OR_OTHER|||||||0.991||95.0|||||t-test, 2 sided|Paired||Change from Baseline to Exit Visit LOCF||||0.991
72403513|NCT02932904|144312920|SUPERIORITY||LS Mean Difference|-0.33|STANDARD_ERROR_OF_MEAN|0.6||0.581|TWO_SIDED|95.0|-1.51|0.85|||ANCOVA with LOCF|||Week 1, ANCOVA model with the LOCF method was used for p-value with treatment, pooled center, and gender as fixed factors and with baseline CSFQ-14 total score as a covariate.||0.85|-1.51|0.581
72568197|NCT00706381|144667938|SUPERIORITY||Percent change from placebo|7.87|STANDARD_DEVIATION|9.2||0.0001|TWO_SIDED||||||t-test, 2 sided|||The percent change from placebo was calculated for each participant and then a t-test was used to test the null hypothesis that this difference was equal to 0.||||0.0001
72568198|NCT00706381|144667938|SUPERIORITY||Percent change from placebo|9.25|STANDARD_DEVIATION|8.3|<|0.0001|TWO_SIDED||||||t-test, 2 sided|||The percent change from placebo was calculated for each participant and then a t-test was used to test the null hypothesis that this difference was equal to 0.||||<0.0001
72568199|NCT00706381|144667938|SUPERIORITY||Mean Difference (Net)|0.1|STANDARD_DEVIATION|6.2||0.89|TWO_SIDED||||||Percent change from placebo|||The percent change from placebo was calculated for each participant and then a t-test was used to test the null hypothesis that this difference was equal to 0.||||0.89
72568200|NCT00706381|144667938|SUPERIORITY||Percent change from placebo|-0.3|STANDARD_DEVIATION|7.2||0.41|TWO_SIDED||||||t-test, 2 sided|||The percent change from placebo was calculated for each participant and then a t-test was used to test the null hypothesis that this difference was equal to 0.||||0.41
72568201|NCT00706381|144667939|SUPERIORITY||Percent change from placebo|40.0|STANDARD_DEVIATION|72.8||0.096|TWO_SIDED||||||t-test, 2 sided|||The percent change from placebo was calculated for each participant and then a t-test was used to test the null hypothesis that this difference was equal to 0.||||0.096
72568202|NCT00706381|144667939|SUPERIORITY||Percent change from placebo|260.4|STANDARD_DEVIATION|191.7|<|0.0001|TWO_SIDED||||||t-test, 2 sided|||The percent change from placebo was calculated for each participant and then a t-test was used to test the null hypothesis that this difference was equal to 0.||||<0.0001
72568203|NCT00706381|144667939|SUPERIORITY||Percent change from placebo|16.4|STANDARD_DEVIATION|56.3||0.83|TWO_SIDED||||||t-test, 2 sided|||The percent change from placebo was calculated for each participant and then a t-test was used to test the null hypothesis that this difference was equal to 0.||||0.83
72568204|NCT00706381|144667939|SUPERIORITY||Percent change from placebo|125.7|STANDARD_DEVIATION|92.2|<|0.0001|TWO_SIDED||||||t-test, 2 sided|||The percent change from placebo was calculated for each participant and then a t-test was used to test the null hypothesis that this difference was equal to 0.||||<0.0001
72568205|NCT01640873|144668004|OTHER||Least Squares Mean Difference|-8.5||||0.356|TWO_SIDED|90.0|-47.4|30.4||The posterior probability that the reduction in FPG is ≥ 20 mg/dL is 0.06, and hence, the FPG hypothesis was not met.|Constrained longitudinal data analysis|||||30.4|-47.4|0.356
72568206|NCT01640873|144668006|OTHER||Geometric Mean Ratio|1.05||||0.2714|TWO_SIDED|90.0|0.92|1.19||The posterior probability that the reduction in 24h-WMG is ≥ 20 mg/dL is \< 0.01, and hence, the 24h- WMG hypothesis was not met.|Constrained longitudinal data analysis|||||1.19|0.92|0.2714
72568207|NCT01640873|144668007|OTHER|Day 1|Geometric Mean Ratio|1.22||||0.06|TWO_SIDED|95.0|0.99|1.55|||ANOVA|Placebo-corrected (MK-8655 / placebo)||||1.55|0.99|0.060
72568208|NCT01640873|144668007|OTHER|Day 3|Geometric mean Ratio|1.2||||0.065|TWO_SIDED|95.0|0.98|1.47|||ANOVA|Placebo-corrected (MK-8655 / placebo)||||1.47|0.98|0.065
72568209|NCT01640873|144668007|OTHER|Day 16|Geometric Mean Ratio|1.1||||0.217|TWO_SIDED|95.0|0.89|1.37|||ANOVA|Placebo-corrected (MK-8655 / placebo)||||1.37|0.89|0.217
72577103|NCT00580788|144680818|NON_INFERIORITY_OR_EQUIVALENCE|The study was designed as a standard dose-escalation study, dose-finding pilot study. The primary outcome measures were safety (hypercalcemia, hypophosphatemia and symptoms/hemodynamic measurements). A modified Fibronacci dose-escalation scheme was employed.|||||>|0.05|TWO_SIDED|||||The reported p-value corresponds to the % change from baseline at follow-up in all Arms/groups|Mixed Models Analysis|The level of statistical significance was set at .05 (two-tailed)||||||>0.05
72403514|NCT02932904|144312920|SUPERIORITY||LS Mean Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.828||0.938|TWO_SIDED|95.0|-1.69|1.56|||ANCOVA with LOCF|||Week 2, ANCOVA model with the LOCF method was used for p-value with treatment, pooled center, and gender as fixed factors and with baseline CSFQ-14 total score as a covariate.||1.56|-1.69|0.938
72403515|NCT02932904|144312920|SUPERIORITY||LS Mean Difference|-0.44|STANDARD_ERROR_OF_MEAN|0.814||0.592|TWO_SIDED|95.0|-2.04|1.17|||ANCOVA with LOCF|||Week 2, ANCOVA model with the LOCF method was used for p-value with treatment, pooled center, and gender as fixed factors and with baseline CSFQ-14 total score as a covariate.||1.17|-2.04|0.592
72403516|NCT02932904|144312920|SUPERIORITY||LS Mean Difference|0.15|STANDARD_ERROR_OF_MEAN|0.886||0.87|TWO_SIDED|95.0|-1.6|1.89|||ANCOVA with LOCF|||Week 3, ANCOVA model with the LOCF method was used for p-value with treatment, pooled center, and gender as fixed factors and with baseline CSFQ-14 total score as a covariate.||1.89|-1.60|0.870
72624221|NCT02546323|144778620|OTHER||Least squares mean difference|5.0|STANDARD_ERROR_OF_MEAN|1.347|<|0.001|TWO_SIDED|95.0|2.35|7.64|||ANCOVA||Treatment as a fixed effect and baseline value as a covariate.|Treatment difference (rosuvastatin 20 mg - placebo): HDL-C||7.64|2.35|<0.001
72624222|NCT02546323|144778620|OTHER||Least squares mean difference|-19.65|STANDARD_ERROR_OF_MEAN|3.671|<|0.001|TWO_SIDED|95.0|-26.86|-12.44|||ANCOVA||Treatment as a fixed effect and baseline value as a covariate.|Treatment difference (rosuvastatin 20 mg - placebo): Triglycerides||-12.44|-26.86|<0.001
72624223|NCT02546323|144778620|OTHER||Least squares mean difference|-29.49|STANDARD_ERROR_OF_MEAN|1.917|<|0.001|TWO_SIDED|95.0|-33.25|-25.72|||ANCOVA||Treatment as a fixed effect and baseline value as a covariate.|Treatment difference (rosuvastatin 20 mg - placebo): Non-HDL-C||-25.72|-33.25|<0.001
72624224|NCT02546323|144778620|OTHER||Least squares mean difference|-31.75|STANDARD_ERROR_OF_MEAN|2.334|<|0.001|TWO_SIDED|95.0|-36.33|-27.16|||ANCOVA||Treatment as a fixed effect and baseline value as a covariate.|Treatment difference (rosuvastatin 20 mg - placebo): Non-HDL-C/HDL-C ratio||-27.16|-36.33|<0.001
72624225|NCT02546323|144778620|OTHER||Least squares mean difference|-26.12|STANDARD_ERROR_OF_MEAN|1.84|<|0.001|TWO_SIDED|95.0|-29.73|-22.5|||ANCOVA||Treatment as a fixed effect and baseline value as a covariate.|Treatment difference (rosuvastatin 20 mg - placebo): ApoB||-22.50|-29.73|<0.001
72624226|NCT02546323|144778620|OTHER||Least squares mean difference|2.19|STANDARD_ERROR_OF_MEAN|1.104||0.047|TWO_SIDED|95.0|0.02|4.36|||ANCOVA||Treatment as a fixed effect and baseline value as a covariate|Treatment difference (rosuvastatin 20 mg - placebo): ApoA-I||4.36|0.02|0.047
72624227|NCT02546323|144778620|OTHER||Least squares mean difference|-26.77|STANDARD_ERROR_OF_MEAN|2.041|<|0.001|TWO_SIDED|95.0|-30.78|-22.76|||ANCOVA||Treatment as a fixed effect and baseline value as a covariate.|Treatment difference (rosuvastatin 20 mg - placebo): ApoB/ApoA-I ratio||-22.76|-30.78|<0.001
72403517|NCT02932904|144312920|SUPERIORITY||LS Mean Difference|-1.44|STANDARD_ERROR_OF_MEAN|0.871||0.098|TWO_SIDED|95.0|-3.16|0.27|||ANCOVA with LOCF|||Week 3, ANCOVA model with the LOCF method was used for p-value with treatment, pooled center, and gender as fixed factors and with baseline CSFQ-14 total score as a covariate.||0.27|-3.16|0.098
72403518|NCT02932904|144312920|SUPERIORITY||LS Mean Difference|-0.58|STANDARD_ERROR_OF_MEAN|0.923||0.532|TWO_SIDED|95.0|-2.39|1.24|||ANCOVA with LOCF|||Week 4, ANCOVA model with the LOCF method was used for p-value with treatment, pooled center, and gender as fixed factors and with baseline CSFQ-14 total score as a covariate.||1.24|-2.39|0.532
72624228|NCT02546323|144778621|OTHER||Least squares mean difference|-39.51|STANDARD_ERROR_OF_MEAN|1.819|<|0.001|TWO_SIDED|95.0|-43.08|-35.94|||ANCOVA||Treatment as a fixed effect and baseline value as a covariate.|Treatment difference (rosuvastatin 20 mg - placebo): LDL-C||-35.94|-43.08|<0.001
72624229|NCT02546323|144778621|OTHER||Least squares mean difference|-25.46|STANDARD_ERROR_OF_MEAN|1.139|<|0.001|TWO_SIDED|95.0|-27.7|-23.23|||ANCOVA||Treatment as a fixed effect and baseline value as a covariate.|Treatment difference (rosuvastatin 20 mg - placebo): total cholesterol||-23.23|-27.70|<0.001
72624230|NCT02546323|144778621|OTHER||Least squares mean difference|3.67|STANDARD_ERROR_OF_MEAN|1.051|<|0.001|TWO_SIDED|95.0|1.6|5.73|||ANCOVA||Treatment as a fixed effect and baseline value as a covariate.|Treatment difference (rosuvastatin 20 mg - placebo): HDL-C||5.73|1.60|<0.001
72624231|NCT02546323|144778621|OTHER||Least squares mean difference|-18.41|STANDARD_ERROR_OF_MEAN|2.981|<|0.001|TWO_SIDED|95.0|-24.26|-12.55|||ANCOVA||Treatment as a fixed effect and baseline value as a covariate.|Treatment difference (rosuvastatin 20 mg - placebo): Triglycerides||-12.55|-24.26|<0.001
72403519|NCT02932904|144312920|SUPERIORITY||LS Mean Difference|-1.82|STANDARD_ERROR_OF_MEAN|0.907||0.046|TWO_SIDED|95.0|-3.6|-0.03|||ANCOVA with LOCF|||Week 4, ANCOVA model with the LOCF method was used for p-value with treatment, pooled center, and gender as fixed factors and with baseline CSFQ-14 total score as a covariate.||-0.03|-3.60|0.046
72515078|NCT03334396|144560973|SUPERIORITY||Odds Ratio (OR)|1.94||||0.441|TWO_SIDED|95.0|0.36|10.41|||Regression, Logistic|||||10.41|0.36|0.441
72515079|NCT03334396|144560974|SUPERIORITY||Mean Difference (Final Values)|-5.34|STANDARD_ERROR_OF_MEAN|3.17||0.093|TWO_SIDED|95.0|-11.57|0.9|||Mixed Models Analysis|||||0.90|-11.57|0.093
72515080|NCT03334396|144560974|SUPERIORITY||Mean Difference (Final Values)|-7.97|STANDARD_ERROR_OF_MEAN|3.07||0.01|TWO_SIDED|95.0|-14.01|-1.92|||Mixed Models Analysis|||||-1.92|-14.01|0.010
72515081|NCT03334396|144560974|SUPERIORITY||Mean Difference (Final Values)|-14.79|STANDARD_ERROR_OF_MEAN|2.88|<|0.001|TWO_SIDED|95.0|-20.46|-9.13|||Mixed Models Analysis|||||-9.13|-20.46|<0.001
72515082|NCT03334396|144560975|SUPERIORITY||Odds Ratio (OR)|1.17||||0.874|TWO_SIDED|95.0|0.17|7.77|||Regression, Logistic|||||7.77|0.17|0.874
72515083|NCT03334396|144560975|SUPERIORITY||Odds Ratio (OR)|2.88||||0.176|TWO_SIDED|95.0|0.62|13.36|||Regression, Logistic|||||13.36|0.62|0.176
72515084|NCT03334396|144560975|SUPERIORITY||Odds Ratio (OR)|2.72||||0.201|TWO_SIDED|95.0|0.59|12.65|||Regression, Logistic|||||12.65|0.59|0.201
72515085|NCT03334396|144560976|SUPERIORITY||Mean Difference (Final Values)|-5.99|STANDARD_ERROR_OF_MEAN|2.88||0.039|TWO_SIDED|95.0|-11.67|-0.31|||Mixed Models Analysis|||||-0.31|-11.67|0.039
72515086|NCT03334396|144560976|SUPERIORITY||Mean Difference (Final Values)|-5.34|STANDARD_ERROR_OF_MEAN|2.8||0.058|TWO_SIDED|95.0|-10.86|0.18|||Mixed Models Analysis|||||0.18|-10.86|0.058
72515087|NCT03334396|144560976|SUPERIORITY||Mean Difference (Final Values)|-11.16|STANDARD_DEVIATION|2.63|<|0.001|TWO_SIDED|95.0|-16.33|-5.98|||Mixed Models Analysis|||||-5.98|-16.33|<0.001
72624232|NCT02546323|144778621|OTHER||Least squares mean difference|-33.78|STANDARD_ERROR_OF_MEAN|1.529|<|0.001|TWO_SIDED|95.0|-36.78|-30.78|||ANCOVA||Treatment as a fixed effect and baseline value as a covariate.|Treatment difference (rosuvastatin 20 mg - placebo): Non-HDL-C||-30.78|-36.78|<0.001
72403520|NCT02932904|144312920|SUPERIORITY||LS Mean Difference|-0.03|STANDARD_ERROR_OF_MEAN|1.018||0.977|TWO_SIDED|95.0|-2.03|1.97|||ANCOVA with LOCF|||Week 5, ANCOVA model with the LOCF method was used for p-value with treatment, pooled center, and gender as fixed factors and with baseline CSFQ-14 total score as a covariate.||1.97|-2.03|0.977
72515088|NCT03334396|144560977|SUPERIORITY|||||||0.067|||||||Fisher Exact|||||||0.067
72515089|NCT03334396|144560977|SUPERIORITY|||||||0.799|||||||Fisher Exact|||||||0.799
72515090|NCT03334396|144560977|SUPERIORITY|||||||0.782|||||||Fisher Exact|||||||0.782
72515091|NCT03334396|144560978|SUPERIORITY||Mean Difference (Final Values)|-19.25|STANDARD_ERROR_OF_MEAN|7.33||0.009|TWO_SIDED|95.0|-33.69|-4.81|||Mixed Models Analysis|||||-4.81|-33.69|0.009
72515092|NCT03334396|144560978|SUPERIORITY||Mean Difference (Final Values)|-17.39|STANDARD_ERROR_OF_MEAN|7.13||0.015|TWO_SIDED|95.0|-31.43|-3.35|||Mixed Models Analysis|||||-3.35|-31.43|0.015
72515093|NCT03334396|144560978|SUPERIORITY||Mean Difference (Final Values)|-24.5|STANDARD_ERROR_OF_MEAN|6.71|<|0.001|TWO_SIDED|95.0|-37.71|-11.3|||Mixed Models Analysis|||||-11.30|-37.71|<0.001
72515094|NCT03334396|144560979|SUPERIORITY||Mean Difference (Final Values)|-2.63|STANDARD_ERROR_OF_MEAN|1.19||0.028|TWO_SIDED|95.0|-4.98|-0.29|||Mixed Models Analysis|||||-0.29|-4.98|0.028
72515095|NCT03334396|144560979|SUPERIORITY||Mean Difference (Final Values)|-3.58|STANDARD_ERROR_OF_MEAN|1.17||0.003|TWO_SIDED|95.0|-5.89|-1.27|||Mixed Models Analysis|||||-1.27|-5.89|0.003
72515096|NCT03334396|144560979|SUPERIORITY||Mean Difference (Final Values)|-5.16|STANDARD_ERROR_OF_MEAN|1.1|<|0.001|TWO_SIDED|95.0|-7.33|-2.99|||Mixed Models Analysis|||||-2.99|-7.33|<0.001
72515097|NCT03334396|144560980|SUPERIORITY||Mean Difference (Final Values)|-0.27|STANDARD_ERROR_OF_MEAN|0.15||0.069|TWO_SIDED|95.0|-0.56|0.02|||Mixed Models Analysis|||||0.02|-0.56|0.069
72515098|NCT03334396|144560980|SUPERIORITY||Mean Difference (Final Values)|-0.27|STANDARD_ERROR_OF_MEAN|0.15||0.066|TWO_SIDED|95.0|-0.56|0.02|||Mixed Models Analysis|||||0.02|-0.56|0.066
72577104|NCT00580788|144680819|NON_INFERIORITY_OR_EQUIVALENCE|The study was designed as a standard dose-escalation study, dose-finding pilot study. The primary outcome measures were safety (hypercalcemia, hypophosphatemia and symptoms/hemodynamic measurements). A modified Fibronacci dose-escalation scheme was employed.|||||<|0.0001|TWO_SIDED|||||the reported p-value corresponds to % decrease compared to baseline at Days 2-8 in all Arms/groups|Mixed Models Analysis|The level of statistical significance was set at .05 (two-tailed)||||||<.0001
72403521|NCT02932904|144312920|SUPERIORITY||LS Mean Difference|-1.72|STANDARD_ERROR_OF_MEAN|1.0||0.087|TWO_SIDED|95.0|-3.68|0.25|||ANCOVA with LOCF|||Week 5, ANCOVA model with the LOCF method was used for p-value with treatment, pooled center, and gender as fixed factors and with baseline CSFQ-14 total score as a covariate.||0.25|-3.68|0.087
72515099|NCT03334396|144560980|SUPERIORITY||Mean Difference (Final Values)|-0.46|STANDARD_ERROR_OF_MEAN|0.14|<|0.001|TWO_SIDED|95.0|-0.73|-0.19|||Mixed Models Analysis|||||-0.19|-0.73|<0.001
72515100|NCT03334396|144560981|SUPERIORITY||Mean Difference (Final Values)|-0.45|STANDARD_ERROR_OF_MEAN|0.43||0.305|TWO_SIDED|95.0|-1.3|0.41|||Mixed Models Analysis|||HADS Anxiety||0.41|-1.30|0.305
72515101|NCT03334396|144560981|SUPERIORITY||Mean Difference (Final Values)|-0.93|STANDARD_ERROR_OF_MEAN|0.42||0.029|TWO_SIDED|95.0|-1.77|-0.1|||Mixed Models Analysis|||HADS Anxiety||-0.10|-1.77|0.029
72515102|NCT03334396|144560981|SUPERIORITY||Mean Difference (Final Values)|-1.15|STANDARD_ERROR_OF_MEAN|0.4||0.004|TWO_SIDED|95.0|-1.93|-0.36|||Mixed Models Analysis|||HADS Anxiety||-0.36|-1.93|0.004
72515103|NCT03334396|144560981|SUPERIORITY||Mean Difference (Final Values)|-0.68|STANDARD_ERROR_OF_MEAN|0.43||0.113|TWO_SIDED|95.0|-1.51|0.16|||Mixed Models Analysis|||HADS Depression||0.16|-1.51|0.113
72515104|NCT03334396|144560981|SUPERIORITY||Mean Difference (Final Values)|-1.03|STANDARD_ERROR_OF_MEAN|0.42||0.014|TWO_SIDED|95.0|-1.85|-0.22|||Mixed Models Analysis|||HADS Depression||-0.22|-1.85|0.014
72515105|NCT03334396|144560981|SUPERIORITY||Mean Difference (Final Values)|-1.14|STANDARD_ERROR_OF_MEAN|0.39||0.004|TWO_SIDED|95.0|-1.91|-0.37|||Mixed Models Analysis|||HADS Depression||-0.37|-1.91|0.004
72515106|NCT03334396|144560982|SUPERIORITY||Mean Difference (Final Values)|-2.17|STANDARD_ERROR_OF_MEAN|0.89||0.015|TWO_SIDED|95.0|-3.92|-0.42|||Mixed Models Analysis|||||-0.42|-3.92|0.015
72515107|NCT03334396|144560982|SUPERIORITY||Mean Difference (Final Values)|-1.84|STANDARD_ERROR_OF_MEAN|0.87||0.036|TWO_SIDED|95.0|-3.56|-0.12|||Mixed Models Analysis|||||-0.12|-3.56|0.036
72515108|NCT03334396|144560982|SUPERIORITY||Mean Difference (Final Values)|-4.3|STANDARD_ERROR_OF_MEAN|0.82|<|0.001|TWO_SIDED|95.0|-5.91|-2.69|||Mixed Models Analysis|||||-2.69|-5.91|<0.001
72515109|NCT03334396|144560983|SUPERIORITY||Mean Difference (Final Values)|-4.05|STANDARD_ERROR_OF_MEAN|2.7||0.136|TWO_SIDED|95.0|-9.39|1.29|||Mixed Models Analysis|||Percentage of Absenteeism Change from Baseline||1.29|-9.39|0.136
72515110|NCT03334396|144560983|SUPERIORITY||Mean Difference (Final Values)|-0.35|STANDARD_ERROR_OF_MEAN|2.76||0.898|TWO_SIDED|95.0|-5.81|5.1|||Mixed Models Analysis|||Percentage of Absenteeism Change from Baseline||5.10|-5.81|0.898
72515111|NCT03334396|144560983|SUPERIORITY||Mean Difference (Final Values)|-3.4|STANDARD_ERROR_OF_MEAN|2.49||0.174|TWO_SIDED|95.0|-8.32|1.52|||Mixed Models Analysis|||Percentage of Absenteeism Change from Baseline||1.52|-8.32|0.174
72515112|NCT03334396|144560983|SUPERIORITY||Mean Difference (Final Values)|-6.86|STANDARD_ERROR_OF_MEAN|4.19||0.104|TWO_SIDED|95.0|-15.13|1.41|||Mixed Models Analysis|||Percentage of Presenteeism (Reduced Productivity While at Work) Change from Baseline||1.41|-15.13|0.104
72515113|NCT03334396|144560983|SUPERIORITY||Mean Difference (Final Values)|-8.64|STANDARD_ERROR_OF_MEAN|4.28||0.045|TWO_SIDED|95.0|-17.09|-0.19|||Mixed Models Analysis|||Percentage of Presenteeism (Reduced Productivity While at Work) Change from Baseline||-0.19|-17.09|0.045
72515114|NCT03334396|144560983|SUPERIORITY||Mean Difference (Final Values)|-12.28|STANDARD_ERROR_OF_MEAN|3.9||0.002|TWO_SIDED|95.0|-19.97|-4.59|||Mixed Models Analysis|||Percentage of Presenteeism (Reduced Productivity While at Work) Change from Baseline||-4.59|-19.97|0.002
72515115|NCT03334396|144560983|SUPERIORITY||Mean Difference (Final Values)|-8.66|STANDARD_ERROR_OF_MEAN|4.67||0.066|TWO_SIDED|95.0|-17.89|0.57|||Mixed Models Analysis|||Work Productivity Loss (Percentage Overall Work Impairment/Absenteeism Plus Presenteeism) Change from Baseline||0.57|-17.89|0.066
72515116|NCT03334396|144560983|SUPERIORITY||Mean Difference (Final Values)|-6.49|STANDARD_ERROR_OF_MEAN|4.76||0.175|TWO_SIDED|95.0|-15.89|2.91|||Mixed Models Analysis|||Work Productivity Loss (Percentage Overall Work Impairment/Absenteeism Plus Presenteeism) Change from Baseline||2.91|-15.89|0.175
72515117|NCT03334396|144560983|SUPERIORITY||Mean Difference (Final Values)|-11.28|STANDARD_ERROR_OF_MEAN|4.34||0.01|TWO_SIDED|95.0|-19.84|-2.72|||Mixed Models Analysis|||Work Productivity Loss (Percentage Overall Work Impairment/Absenteeism Plus Presenteeism) Change from Baseline||-2.72|-19.84|0.010
72515118|NCT03334396|144560983|SUPERIORITY||Mean Difference (Final Values)|-7.31|STANDARD_ERROR_OF_MEAN|3.36||0.03|TWO_SIDED|95.0|-13.93|-0.7|||Mixed Models Analysis|||Percentage of Activity Impairment Change from Baseline||-0.70|-13.93|0.030
72515119|NCT03334396|144560983|SUPERIORITY||Mean Difference (Final Values)|-5.13|STANDARD_ERROR_OF_MEAN|3.31||0.122|TWO_SIDED|95.0|-11.65|1.39|||Mixed Models Analysis|||Percentage of Activity Impairment Change from Baseline||1.39|-11.65|0.122
72624233|NCT02546323|144778621|OTHER||Least squares mean difference|-33.93|STANDARD_ERROR_OF_MEAN|1.836|<|0.001|TWO_SIDED|95.0|-37.54|-30.32|||ANCOVA||Treatment as a fixed effect and baseline value as a covariate.|Treatment difference (rosuvastatin 20 mg - placebo): Non-HDL-C/HDL-C ratio||-30.32|-37.54|<0.001
72515120|NCT03334396|144560983|SUPERIORITY||Mean Difference (Final Values)|-16.52|STANDARD_ERROR_OF_MEAN|3.11|<|0.001|TWO_SIDED|95.0|-22.64|-10.41|||Mixed Models Analysis|||Percentage of Activity Impairment Change from Baseline||-10.41|-22.64|<0.001
72515121|NCT03334396|144560984|SUPERIORITY||Mean Difference (Final Values)|0.04|STANDARD_ERROR_OF_MEAN|0.02||0.061|TWO_SIDED|95.0|0.0|0.08|||Mixed Models Analysis|||Health State Index Score (US algorithm)||0.08|-0.00|0.061
72515122|NCT03334396|144560984|SUPERIORITY||Mean Difference (Final Values)|0.04|STANDARD_ERROR_OF_MEAN|0.02||0.06|TWO_SIDED|95.0|0.0|0.08|||Mixed Models Analysis|||Health State Index Score (US algorithm)||0.08|-0.00|0.060
72515123|NCT03334396|144560984|SUPERIORITY||Mean Difference (Final Values)|0.08|STANDARD_ERROR_OF_MEAN|0.02|<|0.001|TWO_SIDED|95.0|0.04|0.12|||Mixed Models Analysis|||Health State Index Score (US algorithm)||0.12|0.04|<0.001
72624234|NCT00863304|144778623|SUPERIORITY_OR_OTHER_LEGACY||Least Square (LS) Mean Difference|-1.13|STANDARD_ERROR_OF_MEAN|0.26|<|0.001|TWO_SIDED|95.0|-1.65|-0.62||P-value was based on pairwise comparisons.|ANCOVA|||Analysis of Covariance (ANCOVA) was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.62|-1.65|<0.001
72624235|NCT00863304|144778623|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.26||0.002|TWO_SIDED|95.0|-1.32|-0.29||P-value was based on pairwise comparisons.|ANCOVA|||ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.29|-1.32|0.002
72624236|NCT00863304|144778623|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.45|STANDARD_ERROR_OF_MEAN|0.26||0.09|TWO_SIDED|95.0|-0.96|0.07||P-value was based on pairwise comparisons.|ANCOVA|||ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||0.07|-0.96|0.090
72624237|NCT00863304|144778623|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.69|STANDARD_ERROR_OF_MEAN|0.26||0.009|TWO_SIDED|95.0|-1.21|-0.17||P-value was based on pairwise comparisons.|ANCOVA|||ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.17|-1.21|0.009
72624238|NCT00863304|144778623|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.36|STANDARD_ERROR_OF_MEAN|0.26||0.175|TWO_SIDED|95.0|-0.87|0.16||P-value was based on pairwise comparisons.|ANCOVA|||ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||0.16|-0.87|0.175
72624239|NCT00863304|144778624|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.23|STANDARD_ERROR_OF_MEAN|0.25|<|0.001|TWO_SIDED|95.0|-1.71|-0.75||P-value was based on pairwise comparisons.|ANCOVA|||ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.75|-1.71|<0.001
72624240|NCT00863304|144778624|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.99|STANDARD_ERROR_OF_MEAN|0.25|<|0.001|TWO_SIDED|95.0|-1.48|-0.51||P-value was based on pairwise comparisons.|ANCOVA|||ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.51|-1.48|<0.001
72624241|NCT00863304|144778624|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.46|STANDARD_ERROR_OF_MEAN|0.25||0.067|TWO_SIDED|95.0|-0.94|0.03||P-value was based on pairwise comparisons.|ANCOVA|||ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||0.03|-0.94|0.067
72624242|NCT00863304|144778624|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.77|STANDARD_ERROR_OF_MEAN|0.25||0.002|TWO_SIDED|95.0|-1.26|-0.29||P-value was based on pairwise comparisons.|ANCOVA|||ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.29|-1.26|0.002
72624243|NCT00863304|144778624|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.54|STANDARD_ERROR_OF_MEAN|0.25||0.031|TWO_SIDED|95.0|-1.03|-0.05||P-value was based on pairwise comparisons.|ANCOVA|||ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.05|-1.03|0.031
72624244|NCT00863304|144778625|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.34|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-0.5|-0.18||P-value was based on pairwise comparisons.|ANCOVA|||ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.18|-0.50|<0.001
72624245|NCT00863304|144778625|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.32|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-0.48|-0.16||P-value was based on pairwise comparisons.|ANCOVA|||ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.16|-0.48|<0.001
72403522|NCT02932904|144312921|SUPERIORITY|Odds ratio, 95% confidence intervals and p-values are from logistic regression model using the rate of subjects that shifted from normal at baseline to abnormal after baseline as the response and explanatory variables for treatment, baseline CSFQ-14 total score, and gender.|Odds Ratio (OR)|0.44||||0.515|TWO_SIDED|95.0|0.037|5.201|||Regression, Logistic|||Week 1||5.201|0.037|0.515
72403523|NCT02932904|144312921|SUPERIORITY|Odds ratio, 95% confidence intervals and p-values are from logistic regression model using the rate of subjects that shifted from normal at baseline to abnormal after baseline as the response and explanatory variables for treatment, baseline CSFQ-14 total score, and gender.|Odds Ratio (OR)|0.59||||0.677|TWO_SIDED|95.0|0.049|7.051|||Regression, Logistic|||Week 1||7.051|0.049|0.677
72403524|NCT02932904|144312921|SUPERIORITY|Odds ratio, 95% confidence intervals and p-values are from logistic regression model using the rate of subjects that shifted from normal at baseline to abnormal after baseline as the response and explanatory variables for treatment, baseline CSFQ-14 total score, and gender.|Odds Ratio (OR)|1.47||||0.72|TWO_SIDED|95.0|0.181|11.912|||Regression, Logistic|||Week 1||11.912|0.181|0.720
72403525|NCT02932904|144312921|SUPERIORITY|Odds ratio, 95% confidence intervals and p-values are from logistic regression model using the rate of subjects that shifted from normal at baseline to abnormal after baseline as the response and explanatory variables for treatment, baseline CSFQ-14 total score, and gender.|Odds Ratio (OR)|0.65||||0.732|TWO_SIDED|95.0|0.053|7.861|||Regression, Logistic|||Week 1||7.861|0.053|0.732
72403526|NCT02932904|144312921|SUPERIORITY|Odds ratio, 95% confidence intervals and p-values are from logistic regression model using the rate of subjects that shifted from normal at baseline to abnormal after baseline as the response and explanatory variables for treatment, baseline CSFQ-14 total score, and gender.|Odds Ratio (OR)|0.87||||0.913|TWO_SIDED|95.0|0.066|11.303|||Regression, Logistic|||Week 1||11.303|0.066|0.913
72403527|NCT02932904|144312921|SUPERIORITY|Odds ratio, 95% confidence intervals and p-values are from logistic regression model using the rate of subjects that shifted from normal at baseline to abnormal after baseline as the response and explanatory variables for treatment, baseline CSFQ-14 total score, and gender.|Odds Ratio (OR)|0.37||||0.164|TWO_SIDED|95.0|0.09|1.507|||Regression, Logistic|||Week 2||1.507|0.090|0.164
72403528|NCT02932904|144312921|SUPERIORITY|Odds ratio, 95% confidence intervals and p-values are from logistic regression model using the rate of subjects that shifted from normal at baseline to abnormal after baseline as the response and explanatory variables for treatment, baseline CSFQ-14 total score, and gender.|Odds Ratio (OR)|0.25||||0.098|TWO_SIDED|95.0|0.05|1.287|||Regression, Logistic|||Week 2||1.287|0.050|0.098
72403529|NCT02932904|144312921|SUPERIORITY|Odds ratio, 95% confidence intervals and p-values are from logistic regression model using the rate of subjects that shifted from normal at baseline to abnormal after baseline as the response and explanatory variables for treatment, baseline CSFQ-14 total score, and gender.|Odds Ratio (OR)|1.2||||0.758|TWO_SIDED|95.0|0.383|3.731|||Regression, Logistic|||Week 2||3.731|0.383|0.758
72515124|NCT03334396|144560984|SUPERIORITY||Mean Difference (Final Values)|0.06|STANDARD_ERROR_OF_MEAN|0.03||0.046|TWO_SIDED|95.0|0.0|0.11|||Mixed Models Analysis|||Health State Index Score (UK Algorithm)||0.11|0.00|0.046
72515125|NCT03334396|144560984|SUPERIORITY||Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.03||0.059|TWO_SIDED|95.0|0.0|0.11|||Mixed Models Analysis|||Health State Index Score (UK Algorithm)||0.11|-0.00|0.059
72403530|NCT02932904|144312921|SUPERIORITY|Odds ratio, 95% confidence intervals and p-values are from logistic regression model using the rate of subjects that shifted from normal at baseline to abnormal after baseline as the response and explanatory variables for treatment, baseline CSFQ-14 total score, and gender.|Odds Ratio (OR)|0.44||||0.256|TWO_SIDED|95.0|0.107|1.814|||Regression, Logistic|||Week 2||1.814|0.107|0.256
72403531|NCT02932904|144312921|SUPERIORITY|Odds ratio, 95% confidence intervals and p-values are from logistic regression model using the rate of subjects that shifted from normal at baseline to abnormal after baseline as the response and explanatory variables for treatment, baseline CSFQ-14 total score, and gender.|Odds Ratio (OR)|0.3||||0.154|TWO_SIDED|95.0|0.059|1.561|||Regression, Logistic|||Week 2||1.561|0.059|0.154
72403532|NCT02932904|144312921|SUPERIORITY|Odds ratio, 95% confidence intervals and p-values are from logistic regression model using the rate of subjects that shifted from normal at baseline to abnormal after baseline as the response and explanatory variables for treatment, baseline CSFQ-14 total score, and gender.|Odds Ratio (OR)|0.36||||0.16|TWO_SIDED|95.0|0.087|1.497|||Regression, Logistic|||Week 3||1.497|0.087|0.160
72403533|NCT02932904|144312921|SUPERIORITY|Odds ratio, 95% confidence intervals and p-values are from logistic regression model using the rate of subjects that shifted from normal at baseline to abnormal after baseline as the response and explanatory variables for treatment, baseline CSFQ-14 total score, and gender.|Odds Ratio (OR)|0.82||||0.744|TWO_SIDED|95.0|0.252|2.679|||Regression, Logistic|||Week 3||2.679|0.252|0.744
72403534|NCT02932904|144312921|SUPERIORITY|Odds ratio, 95% confidence intervals and p-values are from logistic regression model using the rate of subjects that shifted from normal at baseline to abnormal after baseline as the response and explanatory variables for treatment, baseline CSFQ-14 total score, and gender.|Odds Ratio (OR)|2.43||||0.194|TWO_SIDED|95.0|0.636|9.317|||Regression, Logistic|||Week 3||9.317|0.636|0.194
72403535|NCT02932904|144312921|SUPERIORITY|Odds ratio, 95% confidence intervals and p-values are from logistic regression model using the rate of subjects that shifted from normal at baseline to abnormal after baseline as the response and explanatory variables for treatment, baseline CSFQ-14 total score, and gender.|Odds Ratio (OR)|0.88||||0.871|TWO_SIDED|95.0|0.181|4.261|||Regression, Logistic|||Week 3||4.261|0.181|0.871
72403536|NCT02932904|144312921|SUPERIORITY|Odds ratio, 95% confidence intervals and p-values are from logistic regression model using the rate of subjects that shifted from normal at baseline to abnormal after baseline as the response and explanatory variables for treatment, baseline CSFQ-14 total score, and gender.|Odds Ratio (OR)|2.0||||0.329|TWO_SIDED|95.0|0.497|8.037|||Regression, Logistic|||Week 3||8.037|0.497|0.329
72515126|NCT03334396|144560984|SUPERIORITY||Mean Difference (Final Values)|0.11|STANDARD_ERROR_OF_MEAN|0.03|<|0.001|TWO_SIDED|95.0|0.06|0.16|||Mixed Models Analysis|||Health State Index Score (UK algorithm)||0.16|0.06|<0.001
72624246|NCT00863304|144778625|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.08||0.078|TWO_SIDED|95.0|-0.3|0.02||P-value was based on pairwise comparisons.|ANCOVA|||ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||0.02|-0.30|0.078
72403537|NCT02932904|144312921|SUPERIORITY|Odds ratio, 95% confidence intervals and p-values are from logistic regression model using the rate of subjects that shifted from normal at baseline to abnormal after baseline as the response and explanatory variables for treatment, baseline CSFQ-14 total score, and gender.|Odds Ratio (OR)|0.42||||0.187|TWO_SIDED|95.0|0.119|1.514|||Regression, Logistic|||Week 4||1.514|0.119|0.187
72403538|NCT02932904|144312921|SUPERIORITY|Odds ratio, 95% confidence intervals and p-values are from logistic regression model using the rate of subjects that shifted from normal at baseline to abnormal after baseline as the response and explanatory variables for treatment, baseline CSFQ-14 total score, and gender.|Odds Ratio (OR)|0.82||||0.729|TWO_SIDED|95.0|0.273|2.476|||Regression, Logistic|||Week 4||2.476|0.273|0.729
72403539|NCT02932904|144312921|SUPERIORITY|Odds ratio, 95% confidence intervals and p-values are from logistic regression model using the rate of subjects that shifted from normal at baseline to abnormal after baseline as the response and explanatory variables for treatment, baseline CSFQ-14 total score, and gender.|Odds Ratio (OR)|2.71||||0.133|TWO_SIDED|95.0|0.739|9.917|||Regression, Logistic|||Week 4||9.917|0.739|0.133
72403540|NCT02932904|144312921|SUPERIORITY|Odds ratio, 95% confidence intervals and p-values are from logistic regression model using the rate of subjects that shifted from normal at baseline to abnormal after baseline as the response and explanatory variables for treatment, baseline CSFQ-14 total score, and gender.|Odds Ratio (OR)|1.15||||0.852|TWO_SIDED|95.0|0.266|4.961|||Regression, Logistic|||Week 4||4.961|0.266|0.852
72403541|NCT02932904|144312921|SUPERIORITY|Odds ratio, 95% confidence intervals and p-values are from logistic regression model using the rate of subjects that shifted from normal at baseline to abnormal after baseline as the response and explanatory variables for treatment, baseline CSFQ-14 total score, and gender.|Odds Ratio (OR)|2.23||||0.24|TWO_SIDED|95.0|0.585|8.472|||Regression, Logistic|||Week 4||8.472|0.585|0.240
72403542|NCT02932904|144312921|SUPERIORITY|Odds ratio, 95% confidence intervals and p-values are from logistic regression model using rate of subjects that shifted from normal at baseline to abnormal after baseline as response and explanatory variables for treatment, baseline CSFQ-14 total score, and gender.|Odds Ratio (OR)|0.55||||0.317|TWO_SIDED|95.0|0.166|1.789|||Regression, Logistic|||Week 5||1.789|0.166|0.317
72403543|NCT02932904|144312921|SUPERIORITY|Odds ratio, 95% confidence intervals and p-values are from logistic regression model using the rate of subjects that shifted from normal at baseline to abnormal after baseline as the response and explanatory variables for treatment, baseline CSFQ-14 total score, and gender.|Odds Ratio (OR)|1.15||||0.79|TWO_SIDED|95.0|0.41|3.233|||Regression, Logistic|||Week 5||3.233|0.410|0.790
72403544|NCT02932904|144312921|SUPERIORITY|Odds ratio, 95% confidence intervals and p-values are from logistic regression model using rate of subjects that shifted from normal at baseline to abnormal after baseline as response and explanatory variables for treatment, baseline CSFQ-14 total score, and gender.|Odds Ratio (OR)|3.64||||0.073|TWO_SIDED|95.0|0.888|14.911|||Regression, Logistic|||Week 5||14.911|0.888|0.073
72403545|NCT02932904|144312921|SUPERIORITY|Odds ratio, 95% confidence intervals and p-values are from logistic regression model using rate of subjects that shifted from normal at baseline to abnormal after baseline as response and explanatory variables for treatment, baseline CSFQ-14 total score, and gender.|Odds Ratio (OR)|1.98||||0.371|TWO_SIDED|95.0|0.442|8.902|||Regression, Logistic|||Week 5||8.902|0.442|0.371
72515127|NCT03334396|144560985|SUPERIORITY||Mean Difference (Final Values)|2.97|STANDARD_ERROR_OF_MEAN|3.21||0.356|TWO_SIDED|95.0|-3.36|9.3|||Mixed Models Analysis|||EQ-5D-5L VAS Score||9.30|-3.36|0.356
72624247|NCT00863304|144778625|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.08||0.019|TWO_SIDED|95.0|-0.35|-0.03||P-value was based on pairwise comparisons.|ANCOVA|||ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.03|-0.35|0.019
72624248|NCT00863304|144778625|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.08||0.029|TWO_SIDED|95.0|-0.34|-0.02||P-value was based on pairwise comparisons.|ANCOVA|||ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.02|-0.34|0.029
72624249|NCT00863304|144778626|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.49|STANDARD_ERROR_OF_MEAN|0.23||0.029|TWO_SIDED|95.0|-0.94|-0.05||P-value was based on pairwise comparisons.|ANCOVA|||Week 2: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.05|-0.94|0.029
72624250|NCT00863304|144778626|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.28|STANDARD_ERROR_OF_MEAN|0.23||0.214|TWO_SIDED|95.0|-0.73|0.16||P-value was based on pairwise comparisons.|ANCOVA|||Week 2: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||0.16|-0.73|0.214
72624251|NCT00863304|144778626|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.76|STANDARD_ERROR_OF_MEAN|0.23|<|0.001|TWO_SIDED|95.0|-1.21|-0.32||P-value was based on pairwise comparisons.|ANCOVA|||Week 2: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.32|-1.21|<0.001
72624252|NCT00863304|144778626|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.27|STANDARD_ERROR_OF_MEAN|0.23||0.234|TWO_SIDED|95.0|-0.18|0.72||P-value was based on pairwise comparisons.|ANCOVA|||Week 2: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||0.72|-0.18|0.234
72624253|NCT00863304|144778626|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.48|STANDARD_ERROR_OF_MEAN|0.23||0.034|TWO_SIDED|95.0|0.04|0.93||P-value was based on pairwise comparisons.|ANCOVA|||Week 2: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||0.93|0.04|0.034
72624254|NCT00863304|144778626|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.16|STANDARD_ERROR_OF_MEAN|0.24|<|0.001|TWO_SIDED|95.0|-1.63|-0.7||P-value was based on pairwise comparisons.|ANCOVA|||Week 4: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.70|-1.63|<0.001
72568210|NCT04764630|144668017|SUPERIORITY|To demonstrate an increase in naloxone concentration, the lower bound of the one-sided 97.79% interval for the geometric mean ratio must exclude 1. The results will be transformed back to the original scale by exponentiation to provide treatment geometric means.|Geometric mean ratio|1.95||||0.002|ONE_SIDED|95.6|1.28|||Testing will be conducted sequentially (i.e., start at the initial time and progress forward, stopping if success is achieved) at a 1-sided 0.0221 significance level since an increase in naloxone exposure is expected.|t-test, 1 sided||Data is shown for 10-minute timepoint (first time point tested where an increased was observed). This compares results from the 4 naloxone dose arm (1 every 2.5 min) (numerator) with the 2 naloxone dose arm (1 every 2.5 min) (denominator).|Up to three different time points have been pre-specified for the comparison (10, 12.5, and 15 min). Time points will be evaluated from earliest to latest time. Testing will proceed until either one passes or all pre-specified time points fail. Subject-level naloxone concentrations will be log-transformed. Naloxone concentrations below the lower limit of quantification will result in that time point from that subject being removed for comparisons involving that treatment arm.|This was the first timepoint in the comparison that showed an increase in the 4 naloxone dose arm (1 every 2.5 min) compared to the 2 naloxone dose arm (1 every 2.5 min) and is the reported outcome for this endpoint.||1.28|0.002
72568211|NCT04764630|144668018|SUPERIORITY|To demonstrate an increase in naloxone concentration, the lower bound of the one-sided 97.79% interval for the geometric mean ratio must exclude 1. The results will be transformed back to the original scale by exponentiation to provide treatment geometric means.|Geometric mean ratio|1.98||||0.018|ONE_SIDED|95.6|1.03|||Testing will be conducted sequentially (i.e., start at the initial time and progress forward, stopping if success is achieved) at a 1-sided 0.0221 significance level since an increase in naloxone exposure is expected.|t-test, 1 sided||Data is shown for 4.5-minute timepoint (first time point tested where an increased was observed). This compares results from the 4 naloxone dose arm (2 doses every 2.5 min) (numerator) with the 2 naloxone dose arm (1 every 2.5 min) (denominator).|Up to three different time points have been pre-specified for the comparison (4.5, 7, and 10 minutes). Time points will be evaluated from earliest to latest time. Testing will proceed until either one passes or all pre-specified time points fail. Subject-level naloxone concentrations will be log-transformed. Naloxone concentrations below the lower limit of quantification will result in that time point from that subject being removed for comparisons involving that treatment arm.|This was the first timepoint in the comparison that showed an increase in the 4 naloxone dose arm (2 doses every 2.5 min) compared to the 2 naloxone dose arm (1 every 2.5 min) and is the reported outcome for this endpoint.||1.03|0.018
72568212|NCT04764630|144668019|SUPERIORITY|To demonstrate an increase in naloxone concentration, the lower bound of the one-sided 97.79% interval for the geometric mean ratio must exclude 1. The results will be transformed back to the original scale by exponentiation to provide treatment geometric means.|Geometric mean ratio|1.69||||0.013|ONE_SIDED|95.6|1.06|||Testing will be conducted sequentially (i.e., start at the initial time and progress forward, stopping if success is achieved) at a 1-sided 0.0221 significance level since an increase in naloxone exposure is expected.|t-test, 1 sided||Data is shown for 4.5-minute timepoint (first time point tested where an increased was observed). This compares results from the 4 naloxone dose arm (2 doses every 2.5 min) (numerator) with the 4 naloxone dose arm (1 every 2.5 min) (denominator).|Up to three different time points have been pre-specified for the comparison (4.5, 7, and 10 minutes). Time points will be evaluated from earliest to latest time. Testing will proceed until either one passes or all pre-specified time points fail. Subject-level naloxone concentrations will be log-transformed. Naloxone concentrations below the lower limit of quantification will result in that time point from that subject being removed for comparisons involving that treatment arm.|This was the first timepoint in the comparison that showed an increase in the 4 naloxone dose arm (2 doses every 2.5 min) compared to the 4 naloxone dose arm (1 every 2.5 min) and is the reported outcome for this endpoint.||1.06|0.013
72568213|NCT04764630|144668020|OTHER|Treatment differences on the log-scale will be estimated for the PK parameters. Geometric mean ratio and 90% CIs will be obtained by exponentiation of the treatment effect and 90% CIs based on the log-transformed scale. Dose-proportionality will be concluded if the confidence interval includes 1. Dose-normalized comparisons were exploratory.|Geometric mean ratio|0.89||||0.1|TWO_SIDED|90.0|0.78|1.0|||Mixed Models Analysis|Dose-normalized comparisons were exploratory.|This compares results from the 4 naloxone dose arm (1 every 2.5 min) (numerator) with the 2 naloxone dose arm (1 every 2.5 min) (denominator).|Dose-adjusted values for Cmax will be calculated based on noncompartmental PK parameter results, normalized to per mg of naloxone administered. Using linear mixed-effects modeling, comparisons of log-transformed dose-adjusted PK parameters will be performed. Treatment will be a fixed effect. Participant will be included as a random effect on the intercept.||1.00|0.78|0.10
72568214|NCT04764630|144668020|OTHER|Treatment differences on the log-scale will be estimated for the PK parameters. Geometric mean ratio and 90% CIs will be obtained by exponentiation of the treatment effect and 90% CIs based on the log-transformed scale. Dose-proportionality will be concluded if the confidence interval includes 1. Dose-normalized comparisons were exploratory.|Geometric mean ratio|0.77||||0.018|TWO_SIDED|90.0|0.65|0.92|||Mixed Models Analysis|Dose-normalized comparisons were exploratory.|This compares results from the 4 naloxone dose arm (2 every 2.5 min) (numerator) with the 2 naloxone dose arm (1 every 2.5 min) (denominator).|Dose-adjusted values for Cmax will be calculated based on noncompartmental PK parameter results, normalized to per mg of naloxone administered. Using linear mixed-effects modeling, comparisons of log-transformed dose-adjusted PK parameters will be performed. Treatment will be a fixed effect. Participant will be included as a random effect on the intercept.||0.92|0.65|0.018
72403546|NCT02932904|144312921|SUPERIORITY|Odds ratio, 95% confidence intervals and p-values are from logistic regression model using rate of subjects that shifted from normal at baseline to abnormal after baseline as response and explanatory variables for treatment, baseline CSFQ-14 total score, and gender.|Odds Ratio (OR)|4.19||||0.046|TWO_SIDED|95.0|1.027|17.063|||Regression, Logistic|||Week 5||17.063|1.027|0.046
72403547|NCT02932904|144312924|SUPERIORITY||LS Mean Difference|3.38|STANDARD_ERROR_OF_MEAN|1.082||0.002|TWO_SIDED|95.0|1.25|5.51||The comparisons were between each vortioxetine dose (10 or 20 mg) and paroxetine, and the Holm-Bonferroni method was used to adjust for multiplicity and control the familywise type I error rate at a significance level of 0.05.|ANCOVA with LOCF|||ANCOVA model with the LOCF method was used for p-value with treatment, pooled center, and gender as fixed factors and with baseline CSFQ-14 total score as a covariate.||5.51|1.25|0.002
72403548|NCT02932904|144312924|SUPERIORITY||LS Mean Difference|1.63|STANDARD_ERROR_OF_MEAN|1.068||0.129|TWO_SIDED|95.0|-0.47|3.73||The comparisons were between each vortioxetine dose (10 or 20 mg) and paroxetine, and the Holm-Bonferroni method was used to adjust for multiplicity and control the familywise type I error rate at a significance level of 0.05.|ANCOVA with LOCF|||ANCOVA model with the LOCF method was used for p-value with treatment, pooled center, and gender as fixed factors and with baseline CSFQ-14 total score as a covariate.||3.73|-0.47|0.129
72403549|NCT02932904|144312925|SUPERIORITY||LS Mean Difference|4.31|STANDARD_ERROR_OF_MEAN|1.078|<|0.001|TWO_SIDED|95.0|2.19|6.43||The comparisons were between each vortioxetine dose (10 or 20 mg) and paroxetine, and the Holm-Bonferroni method was used to adjust for multiplicity and control the familywise type I error rate at a significance level of 0.05.|ANCOVA with LOCF|||ANCOVA model with the LOCF method was used for p-value with treatment, pooled center, and gender as fixed factors and with baseline CSFQ-14 total score as a covariate.||6.43|2.19|<0.001
72403550|NCT02932904|144312925|SUPERIORITY||LS Mean Difference|3.06|STANDARD_ERROR_OF_MEAN|1.072||0.005|TWO_SIDED|95.0|0.95|5.17||The comparisons were between each vortioxetine dose (10 or 20 mg) and paroxetine, and the Holm-Bonferroni method was used to adjust for multiplicity and control the familywise type I error rate at a significance level of 0.05.|ANCOVA with LOCF|||ANCOVA model with the LOCF method was used for p-value with treatment, pooled center, and gender as fixed factors and with baseline CSFQ-14 total score as a covariate.||5.17|0.95|0.005
72403551|NCT03387813|144312950|SUPERIORITY||Hazard Ratio (HR)|0.88||||0.1624|TWO_SIDED|95.0|0.74|1.05|||Anderson-Gill model (robust sandwich)|||||1.05|0.74|0.1624
72403552|NCT03387813|144312954|EQUIVALENCE|Clinical equivalence was met if the lower limit of the confidence interval (CI) of ln(HR) for the primary endpoint in Elevated NT-proBNP/BNP only vs. prior HFH only subjects is \> -0.2877 and the upper limit is \< 0.2877.|Hazard Ratio (HR)|0.51|||||TWO_SIDED|90.0|0.44|0.6||||||||0.60|0.44|
72403553|NCT03387813|144312958|SUPERIORITY||Hazard Ratio (HR)|0.85||||0.0958|TWO_SIDED|95.0|0.7|1.03|||Anderson-Gill model (robust sandwich)|||||1.03|0.70|0.0958
72403554|NCT03387813|144312962|SUPERIORITY||Hazard Ratio (HR)|0.83||||0.0644|TWO_SIDED|95.0|0.68|1.01|||Anderson-Gill model (robust sandwich)|||||1.01|0.68|0.0644
72403555|NCT03387813|144312966|SUPERIORITY||Hazard Ratio (HR)|1.04||||0.8867|TWO_SIDED|95.0|0.61|1.77|||Anderson-Gill model (robust sandwich)|||||1.77|0.61|0.8867
72403556|NCT03387813|144312970|SUPERIORITY||Hazard Ratio (HR)|1.09||||0.7119|TWO_SIDED|95.0|0.7|1.7|||Anderson-Gill model (robust sandwich)|||||1.70|0.70|0.7119
72488061|NCT00111800|144504922|SUPERIORITY||Mean Difference (Net)|-0.58||||0.13|TWO_SIDED|95.0|-1.34|0.17|||ANCOVA||The point estimate was calculated as least square mean difference (net values) of placebo and DEN 15 mg.|A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||0.17|-1.34|0.130
72488062|NCT00111800|144504922|SUPERIORITY||Mean Difference (Net)|-1.46|||<|0.001|TWO_SIDED|95.0|-2.23|-0.69|||ANCOVA||The point estimate was calculated as least square mean difference (net values) of placebo and DEN 30 mg.|A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||-0.69|-2.23|<0.001
72403557|NCT03387813|144312974|SUPERIORITY||Mean Difference (Final Values)|-1.35|STANDARD_ERROR_OF_MEAN|1.44||0.3484|TWO_SIDED|95.0|-4.16|1.47|||t-test, 1 sided|||||1.47|-4.16|0.3484
72403558|NCT03387813|144312974|SUPERIORITY||Mean Difference (Final Values)|-0.63|STANDARD_ERROR_OF_MEAN|1.47||0.6684|TWO_SIDED|95.0|-3.51|2.26|||t-test, 1 sided|||||2.26|-3.51|0.6684
72403559|NCT03387813|144312976|SUPERIORITY||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|1.37||0.9901|TWO_SIDED|95.0|-2.68|2.71|||t-test, 1 sided|||||2.71|-2.68|0.9901
72403560|NCT03387813|144312976|SUPERIORITY||Mean Difference (Final Values)|1.48|STANDARD_ERROR_OF_MEAN|1.41||0.2947|TWO_SIDED|95.0|-1.29|4.24|||t-test, 1 sided|||||4.24|-1.29|0.2947
72403561|NCT03387813|144312978|SUPERIORITY||Mean Difference (Final Values)|4.14|STANDARD_ERROR_OF_MEAN|7.36||0.5741|TWO_SIDED|95.0|-10.32|18.6|||t-test, 1 sided|||||18.60|-10.32|0.5741
72403562|NCT03387813|144312978|SUPERIORITY||Mean Difference (Final Values)|2.93|STANDARD_ERROR_OF_MEAN|7.81||0.7077|TWO_SIDED|95.0|-12.41|18.27|||t-test, 1 sided|||||18.27|-12.41|0.7077
72403563|NCT03387813|144312981|EQUIVALENCE|Clinical equivalence was met if the lower limit of the CI of ln(HR) for the primary endpoint in Elevated NT-proBNP/BNP only vs. prior HFH only subjects is \> -0.2877 and the upper limit is \< 0.2877.|Hazard Ratio (HR)|0.46|||||TWO_SIDED|90.0|0.38|0.55||||||||0.55|0.38|
72403564|NCT03387813|144312985|OTHER||||||<|0.0001|||||||ANOVA|||||||<0.0001
72403565|NCT03387813|144312989|OTHER||||||<|0.0001|||||||ANOVA|||||||<0.0001
72488063|NCT00111800|144504922|SUPERIORITY||Mean Difference (Net)|-1.22||||0.002|TWO_SIDED|95.0|-1.99|-0.46|||ANCOVA||The point estimate was calculated as least square mean difference (net values) of placebo and DEN 45 mg.|A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||-0.46|-1.99|0.002
72488064|NCT00111800|144504924|SUPERIORITY||Odds Ratio (OR)|0.92||||0.909|TWO_SIDED|95.0|0.21|3.95|||Regression, Logistic|||Placebo versus DEN 2.5 mg for HbA1c \<=6.5%. A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||3.95|0.21|0.909
72515128|NCT03334396|144560985|SUPERIORITY||Mean Difference (Final Values)|1.34|STANDARD_ERROR_OF_MEAN|3.13||0.668|TWO_SIDED|95.0|-4.81|7.5|||Mixed Models Analysis|||EQ-5D-5L VAS Score||7.50|-4.81|0.668
72403566|NCT03387813|144312993|OTHER|||||||0.0001|||||||ANOVA|||||||0.0001
72403567|NCT03387813|144312999|OTHER||Hazard Ratio (HR)|0.46|||<|0.0001|TWO_SIDED|95.0|0.39|0.54|||Anderson-Gill model (robust sandwich)|||||0.54|0.39|<0.0001
72403568|NCT03387813|144313000|OTHER||Hazard Ratio (HR)|0.63|||<|0.001|TWO_SIDED|95.0|0.53|0.76|||Anderson-Gill model (robust sandwich)|||||0.76|0.53|<0.001
72403569|NCT03387813|144313005|SUPERIORITY||Least Square Means Difference (T vs C)|1.53|STANDARD_ERROR_OF_MEAN|0.64||0.016|TWO_SIDED|95.0|0.29|2.78|||Mixed Models Analysis|||Comparisons of PA Systolic Pressure at 6 months between Treatment vs Control group||2.78|0.29|0.0160
72515129|NCT03334396|144560985|SUPERIORITY||Mean Difference (Final Values)|7.05|STANDARD_ERROR_OF_MEAN|2.95||0.017|TWO_SIDED|95.0|1.25|12.86|||Mixed Models Analysis|||EQ-5D-5L VAS Score||12.86|1.25|0.017
72403570|NCT03387813|144313005|SUPERIORITY||Least Square Means Difference (T vs C)|0.79|STANDARD_ERROR_OF_MEAN|0.39||0.0427|TWO_SIDED|95.0|0.03|1.56|||Mixed Models Analysis|||Comparisons of PA Diastolic Pressure at 6 months between Treatment vs Control group.||1.56|0.03|0.0427
72515130|NCT03334396|144560986|SUPERIORITY||Odds Ratio (OR)|1.38||||0.603|TWO_SIDED|95.0|0.41|4.71|||Regression, Logistic|||||4.71|0.41|0.603
72515131|NCT03334396|144560986|SUPERIORITY||Odds Ratio (OR)|4.08||||0.006|TWO_SIDED|95.0|1.5|11.12|||Regression, Logistic|||||11.12|1.50|0.006
72515132|NCT03334396|144560986|SUPERIORITY||Odds Ratio (OR)|4.72||||0.002|TWO_SIDED|95.0|1.78|12.55|||Regression, Logistic|||||12.55|1.78|0.002
72403571|NCT03387813|144313005|SUPERIORITY||Least Square Means Difference (T vs C)|1.13|STANDARD_ERROR_OF_MEAN|0.48||0.0188|TWO_SIDED|95.0|0.19|2.08|||Mixed Models Analysis|||Comparisons of PA Mean Pressure at 6 months between Treatment vs Control group.||2.08|0.19|0.0188
72403572|NCT03387813|144313005|SUPERIORITY||Least Square Means Difference (T vs C)|0.63|STANDARD_ERROR_OF_MEAN|0.66||0.3405|TWO_SIDED|95.0|-0.66|1.92|||Mixed Models Analysis|||Comparisons of PA Systolic Pressure at 12 months between Treatment vs Control group.||1.92|-0.66|0.3405
72403573|NCT03387813|144313005|SUPERIORITY||Least Square Means Difference (T vs C)|0.2|STANDARD_ERROR_OF_MEAN|0.4||0.6174|TWO_SIDED|95.0|-0.59|0.99|||Mixed Models Analysis|||Comparisons of PA Diastolic Pressure at 12 months between Treatment vs Control group.||0.99|-0.59|0.6174
72403574|NCT03387813|144313005|SUPERIORITY||Least Square Means Difference (T vs C)|0.4|STANDARD_ERROR_OF_MEAN|0.5||0.4231|TWO_SIDED|95.0|-0.58|1.38|||Mixed Models Analysis|||Comparisons of PA Mean Pressure at 12 months between Treatment vs Control group.||1.38|-0.58|0.4231
72403575|NCT03387813|144313006|SUPERIORITY|||||||0.0214|||||||t-test, 2 sided|||Comparison of PA Systolic Pressure AUC between Treatment and Control group.||||0.0214
72403576|NCT03387813|144313006|OTHER|||||||0.1002|||||||t-test, 2 sided|||Comparison of PA Diastolic Pressure AUC between Treatment and Control group.||||0.1002
72515133|NCT00383721|144561036|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||ANCOVA|||||||<0.001
72515134|NCT00383721|144561036|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||ANCOVA|||||||<0.001
72515135|NCT00383721|144561037|SUPERIORITY_OR_OTHER_LEGACY|||||||0.062|||||||ANCOVA|||||||0.062
72515136|NCT00383721|144561037|SUPERIORITY_OR_OTHER_LEGACY|||||||0.583|||||||ANCOVA|||||||0.583
72515137|NCT00383721|144561038|SUPERIORITY_OR_OTHER_LEGACY|||||||0.02|||||||ANCOVA|||||||0.020
72403577|NCT03387813|144313006|OTHER|||||||0.0402|||||||t-test, 2 sided|||Comparison of PA Mean Pressure AUC between Treatment and Control group.||||0.0402
72403578|NCT03387813|144313007|SUPERIORITY||Least Square Means Difference (T vs C)|37.19|STANDARD_ERROR_OF_MEAN|75.52||0.6227|TWO_SIDED|95.0|-111.38|185.77|||Mixed Models Analysis|||Comparisons of change from baseline in BNP levels at 6 months between Treatment vs Control group||185.77|-111.38|0.6227
72515138|NCT00383721|144561038|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||ANCOVA|||||||<0.001
72515139|NCT01283997|144561042|SUPERIORITY||Mean Difference (Final Values)|0.06||||0.54|TWO_SIDED|95.0|-0.13|0.24|||Wilcoxon (Mann-Whitney)|||Difference in the measurements for touch by the fingertip||0.24|-0.13|0.54
72515140|NCT01283997|144561042|OTHER||Mean Difference (Final Values)|0.05||||0.6|TWO_SIDED|95.0|-0.13|0.23|||Wilcoxon (Mann-Whitney)|||Difference in the measurements for touch by the palm||0.23|-0.13|0.60
72624255|NCT00863304|144778626|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.96|STANDARD_ERROR_OF_MEAN|0.24|<|0.001|TWO_SIDED|95.0|-1.42|-0.49||P-value was based on pairwise comparisons.|ANCOVA|||Week 4: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.49|-1.42|<0.001
72624256|NCT00863304|144778626|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.64|STANDARD_ERROR_OF_MEAN|0.24||0.007|TWO_SIDED|95.0|-1.11|-0.18||P-value was based on pairwise comparisons.|ANCOVA|||Week 4: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.18|-1.11|0.007
72624257|NCT00863304|144778626|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.52|STANDARD_ERROR_OF_MEAN|0.24||0.029|TWO_SIDED|95.0|-0.99|-0.05||P-value was based on pairwise comparisons.|ANCOVA|||Week 4: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.05|-0.99|0.029
72624258|NCT00863304|144778626|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.31|STANDARD_ERROR_OF_MEAN|0.24||0.193|TWO_SIDED|95.0|-0.78|0.16||P-value was based on pairwise comparisons.|ANCOVA|||Week 4: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||0.16|-0.78|0.193
72624259|NCT00863304|144778626|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|0.24|<|0.001|TWO_SIDED|95.0|-1.68|-0.73||P-value was based on pairwise comparisons.|ANCOVA|||Week 8: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.73|-1.68|<0.001
72624260|NCT00863304|144778626|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.24||0.001|TWO_SIDED|95.0|-1.28|-0.32||P-value was based on pairwise comparisons.|ANCOVA|||Week 8: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.32|-1.28|0.001
72624261|NCT00863304|144778626|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.62|STANDARD_ERROR_OF_MEAN|0.24||0.011|TWO_SIDED|95.0|-1.1|-0.14||P-value was based on pairwise comparisons.|ANCOVA|||Week 8: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.14|-1.10|0.011
72624262|NCT00863304|144778626|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.58|STANDARD_ERROR_OF_MEAN|0.24||0.017|TWO_SIDED|95.0|-1.06|-0.1||P-value was based on pairwise comparisons.|ANCOVA|||Week 8: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.10|-1.06|0.017
72624263|NCT00863304|144778626|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.24||0.464|TWO_SIDED|95.0|-0.66|0.3||P-value was based on pairwise comparisons.|ANCOVA|||Week 8: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||0.30|-0.66|0.464
72624264|NCT00863304|144778626|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.22|STANDARD_ERROR_OF_MEAN|0.26|<|0.001|TWO_SIDED|95.0|-1.72|-0.72||P-value was based on pairwise comparisons.|ANCOVA|||Week 12: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.72|-1.72|<0.001
72624265|NCT00863304|144778626|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.04|STANDARD_ERROR_OF_MEAN|0.26|<|0.001|TWO_SIDED|95.0|-1.55|-0.54||P-value was based on pairwise comparisons.|ANCOVA|||Week 12: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.54|-1.55|<0.001
72624266|NCT00863304|144778626|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.63|STANDARD_ERROR_OF_MEAN|0.26||0.014|TWO_SIDED|95.0|-1.14|-0.13||P-value was based on pairwise comparisons.|ANCOVA|||Week 12: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.13|-1.14|0.014
72624267|NCT00863304|144778626|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.59|STANDARD_ERROR_OF_MEAN|0.26||0.023|TWO_SIDED|95.0|-1.09|-0.08||P-value was based on pairwise comparisons.|ANCOVA|||Week 12: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.08|-1.09|0.023
72624268|NCT00863304|144778626|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.41|STANDARD_ERROR_OF_MEAN|0.26||0.114|TWO_SIDED|95.0|-0.92|0.1||P-value was based on pairwise comparisons.|ANCOVA|||Week 12: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||0.10|-0.92|0.114
72624269|NCT00863304|144778627|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.49|STANDARD_ERROR_OF_MEAN|0.23||0.029|TWO_SIDED|95.0|-0.94|-0.05||P-value was based on pairwise comparisons.|ANCOVA|||Week 2: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.05|-0.94|0.029
72624270|NCT00863304|144778627|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.28|STANDARD_ERROR_OF_MEAN|0.23||0.214|TWO_SIDED|95.0|-0.73|0.16||P-value was based on pairwise comparisons.|ANCOVA|||Week 2: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||0.16|-0.73|0.214
72624271|NCT00863304|144778627|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.76|STANDARD_ERROR_OF_MEAN|0.23|<|0.001|TWO_SIDED|95.0|-1.21|-0.32||P-value was based on pairwise comparisons.|ANCOVA|||Week 2: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.32|-1.21|<0.001
72624272|NCT00863304|144778627|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.27|STANDARD_ERROR_OF_MEAN|0.23||0.234|TWO_SIDED|95.0|-0.18|0.72||P-value was based on pairwise comparisons.|ANCOVA|||Week 2: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||0.72|-0.18|0.234
72403579|NCT03387813|144313008|SUPERIORITY||Least Square Means Difference (T vs C)|59.78|STANDARD_ERROR_OF_MEAN|76.87||0.4373|TWO_SIDED|95.0|-91.44|211.01|||Mixed Models Analysis|||Comparisons of change from baseline in BNP levels at 12 months between Treatment vs Control group||211.01|-91.44|0.4373
72515141|NCT01283997|144561042|OTHER||Mean Difference (Final Values)|-0.12||||0.37|TWO_SIDED|95.0|-0.4|0.15|||Wilcoxon (Mann-Whitney)|||Difference in the measurements for touch by the forearm||0.15|-0.40|0.37
72515142|NCT01283997|144561043|OTHER||Mean Difference (Final Values)|-0.73||||0.56|TWO_SIDED|95.0|-2.06|0.59|||Wilcoxon (Mann-Whitney)|||Difference in Numbness severity at baseline and week 10.||0.59|-2.06|0.56
72515143|NCT03342937|144561060|SUPERIORITY|1-sided test of single exponential mean with historical null hypothesis of 5.5 months median PFS||||||0.02||||||Sample size of 35 patients was chosen based on detecting the difference between a historical median PFS of 5.5 months and experimental median of 7.3 months, a hazard ratio of 0.75, with 80% power (1-sided test of single exponential mean, α=0.2).|1-sided exponential test|||||||0.02
72403580|NCT03387813|144313009|SUPERIORITY||Least Square Means Difference (T vs C)|468.1|STANDARD_ERROR_OF_MEAN|256.65||0.0692|TWO_SIDED|95.0|-37.09|973.3|||Mixed Models Analysis|||Comparisons of change from baseline in NT-proBNP levels at 6months between Treatment vs Control group||973.30|-37.09|0.0692
72515144|NCT01337167|144561071|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 95% CI of the response rate difference is \>= -10%|Response Rate Difference (V419 - Ctrl)|9.68|||<|0.001|TWO_SIDED|95.0|4.83|14.83|||Miettinen and Nurminen|Response rate, response rate difference and p-value were stratified by brand of birth dose of Hepatitis B vaccine||Non-inferiority for titer \>=1.0 μg/mL||14.83|4.83|<0.001
72515145|NCT01337167|144561071|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 95% CI of the response rate difference is \>= -5%|Response Rate Difference (V419 - Ctrl)|4.87|||<|0.001|TWO_SIDED|95.0|2.23|8.14|||Miettinen and Nurminen|Response rate, response rate difference and p-value were stratified by brand of birth dose of Hepatitis B vaccine||Non-inferiority for titer \>=0.15 μg/mL||8.14|2.23|<0.001
72515146|NCT01337167|144561071|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 95% CI of the response rate difference is \>= -10%|Response Rate Difference (V419-Ctrl)|4.87|||<|0.001|TWO_SIDED|95.0|2.23|8.14|||Miettinen and Nurminen|Response rate, response rate difference and p-value were stratified by brand of birth dose of Hepatitis B vaccine||Secondary Analysis: Non-inferiority for titer \>=0.15 μg/mL||8.14|2.23|<0.001
72515147|NCT01337167|144561072|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 95% CI of the response rate difference is \>= -10%|Response Rate Difference (V419 - Ctrl)|0.84|||<|0.001|TWO_SIDED|95.0|-0.35|2.74|||Miettinen and Nurminen|Response rate, response rate difference and p-value were stratified by brand of birth dose of Hepatitis B vaccine||||2.74|-0.35|<0.001
72515148|NCT01337167|144561073|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 95% CI of the response rate difference is \>= -10%|Response Rate Difference (V419 - Ctrl)|-3.84||||0.002|TWO_SIDED|95.0|-8.02|0.66|||Miettinen and Nurminen|Response rate, response rate difference and p-value were stratified by brand of birth dose of Hepatitis B vaccine||||0.66|-8.02|0.002
72403581|NCT03387813|144313010|SUPERIORITY||Least Square Means Difference (T vs C)|284.67|STANDARD_ERROR_OF_MEAN|268.72||0.2903|TWO_SIDED|95.0|-244.27|813.6|||Mixed Models Analysis|||Comparisons of change from baseline in NT-proBNP levels at 12 months between Treatment vs Control group||813.60|-244.27|0.2903
72515149|NCT01337167|144561074|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 95% CI of the response rate difference is \>= -5%|Response Rate Difference (V419 - Ctrl)|0.39|||<|0.001|TWO_SIDED|95.0|-0.28|1.74|||Miettinen and Nurminen|Response rate, response rate difference and p-value were stratified by brand of birth dose of Hepatitis B vaccine||||1.74|-0.28|<0.001
72515150|NCT01337167|144561075|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 95% CI of the response rate difference is \>= -10%|Response Rate Difference (V419 - Ctrl)|-0.33|||<|0.001|TWO_SIDED|95.0|-1.8|1.6|||Miettinen and Nurminen|Response rate, response rate difference and p-value were stratified by brand of birth dose of Hepatitis B vaccine||||1.60|-1.80|<0.001
72515151|NCT01337167|144561076|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 95% CI of the response rate difference is \>= -10%|Response Rate Difference (V419 - Ctrl)|-4.7||||0.001|TWO_SIDED|95.0|-8.14|-0.97|||Miettinen and Nurminen|Response rate, response rate difference and p-value were stratified by brand of birth dose of Hepatitis B vaccine||||-0.97|-8.14|0.001
72624273|NCT00863304|144778627|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.48|STANDARD_ERROR_OF_MEAN|0.23||0.034|TWO_SIDED|95.0|0.04|0.93||P-value was based on pairwise comparisons.|ANCOVA|||Week 2: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||0.93|0.04|0.034
72403582|NCT03387813|144313011|SUPERIORITY||Hazard Ratio (HR)|0.65|||<|0.0001|TWO_SIDED|95.0|0.53|0.78|||Anderson-Gill model (robust sandwich)|||||0.78|0.53|<0.0001
72403583|NCT03387813|144313012|SUPERIORITY||Hazard Ratio (HR)|0.68|||<|0.0001|TWO_SIDED|95.0|0.57|0.81|||Anderson-Gill model (robust sandwich)|||||0.81|0.57|<0.0001
72403584|NCT01289847|144313028|SUPERIORITY_OR_OTHER|||||||0.01|TWO_SIDED||||||one-sample Poisson rate|||For the primary efficacy analysis, the SABI rate for GAMMAPLEX and the upper bound of its one-sided 99% confidence interval (CI) were estimated by using the exact method for a one-sample Poisson rate.||||0.01
72403585|NCT01289847|144313029|SUPERIORITY_OR_OTHER|||||||0.01|ONE_SIDED|99.0|||||one-sample Poisson method|||||||0.01
72488065|NCT00111800|144504924|SUPERIORITY||Odds Ratio (OR)|1.15||||0.852|TWO_SIDED|95.0|0.27|4.92|||Regression, Logistic|||Placebo versus DEN 7.5 mg for HbA1c \<=6.5%. A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||4.92|0.27|0.852
72488066|NCT00111800|144504924|SUPERIORITY||Odds Ratio (OR)|1.2||||0.795|TWO_SIDED|95.0|0.3|4.83|||Regression, Logistic|||Placebo versus DEN 15 mg for HbA1c \<=6.5%. A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||4.83|0.30|0.795
72488067|NCT00111800|144504924|SUPERIORITY||Odds Ratio (OR)|2.68||||0.135|TWO_SIDED|95.0|0.74|9.77|||Regression, Logistic|||Placebo versus DEN 30 mg for HbA1c \<=6.5%. A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||9.77|0.74|0.135
72488068|NCT00111800|144504924|SUPERIORITY||Odds Ratio (OR)|3.24||||0.085|TWO_SIDED|95.0|0.85|12.37|||Regression, Logistic|||Placebo versus DEN 45 mg for HbA1c \<=6.5%. A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||12.37|0.85|0.085
72488069|NCT00111800|144504924|SUPERIORITY||Odds Ratio (OR)|1.1||||0.866|TWO_SIDED|95.0|0.36|3.36|||Regression, Logistic|||Placebo versus DEN 2.5 mg for HbA1c \<7%. A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||3.36|0.36|0.866
72488070|NCT00111800|144504924|SUPERIORITY||Odds Ratio (OR)|1.99||||0.202|TWO_SIDED|95.0|0.69|5.76|||Regression, Logistic|||Placebo versus DEN 7.5 mg for HbA1c \<7%. A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||5.76|0.69|0.202
72488071|NCT00111800|144504924|SUPERIORITY||Odds Ratio (OR)|1.04||||0.941|TWO_SIDED|95.0|0.35|3.13|||Regression, Logistic|||Placebo versus DEN 15 mg for HbA1c \<7%. A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||3.13|0.35|0.941
72488072|NCT00111800|144504924|SUPERIORITY||Odds Ratio (OR)|2.15||||0.152|TWO_SIDED|95.0|0.76|6.13|||Regression, Logistic|||Placebo versus DEN 30 mg for HbA1c \<7%. A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||6.13|0.76|0.152
72488073|NCT00111800|144504924|SUPERIORITY||Odds Ratio (OR)|3.24||||0.032|TWO_SIDED|95.0|1.11|9.52|||Regression, Logistic|||Placebo versus DEN 45 mg for HbA1c \<7%. A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||9.52|1.11|0.032
72488074|NCT00111800|144504924|SUPERIORITY||Odds Ratio (OR)|0.46||||0.198|TWO_SIDED|95.0|0.14|1.5|||Regression, Logistic|||Placebo versus DEN 2.5 mg for HbA1c reduction \>=0.7%. A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||1.50|0.14|0.198
72403586|NCT05876273|144313034|OTHER|The statistical analysis included general linear models (GLM), with repeated measures (NAP vs UMPC) and a covariate the 1-hour average CGM level prior to initiating either controller. This covariate was used to compute the adjusted performance differences between NAP and UMPC. The data was analyzed using the GLM procedures of IBM SPSS 28.0.||||||0.2||||||1-hour average CGM level prior to initiating either controller was included as a covariate in the analysis. This covariate was used to compute the adjusted performance differences between NAP and UMPC.|GLM with Repeated Measures|General linear models (GLM), with repeated measures (NAP vs UMPC)||||||0.2
72403587|NCT03975647|144313039|OTHER||Hazard Ratio (HR)|0.759||||0.0163|TWO_SIDED|95.0|0.607|0.95|||Log Rank||HR was calculated from Cox proportional hazards model. (line of treatment for metastatic: first versus \[vs\] other; hormone receptor status: negative vs positive; presence or history of brain metastases: yes vs no; ECOG status: 0,1 at randomization.|||0.950|0.607|0.0163
72403588|NCT03975647|144313041|OTHER||Hazard Ratio (HR)|0.639||||0.0078|TWO_SIDED|95.0|0.459|0.891|||Log Rank||HR was calculated from Cox proportional hazards model. (line of treatment for metastatic: first versus \[vs\] other; hormone receptor status: negative vs positive; presence or history of brain metastases: yes vs no; ECOG status: 0,1 at randomization.|||0.891|0.459|0.0078
72403589|NCT03975647|144313042|OTHER|||||||0.2055|||||||Cochran-Mantel-Haenszel|||||||0.2055
72403590|NCT02872116|144313052|SUPERIORITY||Hazard Ratio (HR)|0.71|||<|0.0001|TWO_SIDED|98.4|0.59|0.86|||Log Rank|||||0.86|0.59|<0.0001
72403591|NCT02872116|144313053|SUPERIORITY||Hazard Ratio (HR)|0.68|||<|0.0001|TWO_SIDED|98.0|0.56|0.81|||Log Rank|||||0.81|0.56|<0.0001
72403592|NCT03552575|144313084|SUPERIORITY||Mean Difference (Final Values)|-1.9||||0.19|TWO_SIDED|95.0|-4.8|1.0|||Regression, Linear|Adjusted for randomized treatment, baseline value of the outcome, use of diuretics at baseline and time from randomization to cardiac MRI||||1.0|-4.8|0.19
72488075|NCT00111800|144504924|SUPERIORITY||Odds Ratio (OR)|1.43||||0.481|TWO_SIDED|95.0|0.53|3.85|||Regression, Logistic|||Placebo versus DEN 7.5 mg for HbA1c reduction \>=0.7%. A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||3.85|0.53|0.481
72403593|NCT03552575|144313085|SUPERIORITY||Ratio of adjusted geometric means|0.85||||0.31|TWO_SIDED|95.0|0.63|1.16|||Regression, Linear|Adjusted for randomized treatment, baseline value of the outcome, and use of diuretics at baseline||||1.16|0.63|0.31
72403594|NCT03552575|144313086|SUPERIORITY||Ratio of adjusted geometric means|0.87||||0.41|TWO_SIDED|95.0|0.62|1.22|||Regression, Linear|Adjusted for randomized treatment, baseline value of the outcome, and use of diuretics at baseline||||1.22|0.62|0.41
72403595|NCT03552575|144313087|SUPERIORITY||Mean Difference (Final Values)|-3.1||||0.1|TWO_SIDED|95.0|-6.8|0.6|||Regression, Linear|Adjusted for randomized treatment, baseline value of the outcome, use of diuretics at baseline and time from randomization to cardiac MRI||||0.6|-6.8|0.10
72403596|NCT03552575|144313088|SUPERIORITY||Mean Difference (Final Values)|-2.3||||0.29|TWO_SIDED|95.0|-6.6|2.0|||Regression, Linear|Adjusted for randomized treatment, baseline value of the outcome, use of diuretics at baseline and time from randomization to cardiac MRI||||2.0|-6.6|0.29
72488076|NCT00111800|144504924|SUPERIORITY||Odds Ratio (OR)|1.01||||0.991|TWO_SIDED|95.0|0.36|2.78|||Regression, Logistic|||Placebo versus DEN 15 mg for HbA1c reduction \>=0.7%. A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||2.78|0.36|0.991
72488077|NCT00111800|144504924|SUPERIORITY||Odds Ratio (OR)|3.65||||0.008|TWO_SIDED|95.0|1.41|9.48|||Regression, Logistic|||Placebo versus DEN 30 mg for HbA1c reduction \>=0.7%. A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||9.48|1.41|0.008
72488078|NCT00111800|144504924|SUPERIORITY||Odds Ratio (OR)|2.0||||0.161|TWO_SIDED|95.0|0.76|5.24|||Regression, Logistic|||Placebo versus DEN 45 mg for HbA1c reduction \>=0.7%. A closed test procedure was used,P an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||5.24|0.76|0.161
72488079|NCT00111800|144504925|SUPERIORITY||Odds Ratio (OR)|1.77||||0.38|TWO_SIDED|95.0|0.5|6.3|||Regression, Logistic|||Placebo versus DEN 2.5 mg for FPG \<7mmol/L. A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||6.30|0.50|0.380
72488080|NCT00111800|144504925|SUPERIORITY||Odds Ratio (OR)|2.57||||0.145|TWO_SIDED|95.0|0.72|9.11|||Regression, Logistic|||Placebo versus DEN 7.5 mg for FPG \<7mmol/L. A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||9.11|0.72|0.145
72488081|NCT00111800|144504925|SUPERIORITY||Odds Ratio (OR)|1.09||||0.906|TWO_SIDED|95.0|0.26|4.62|||Regression, Logistic|||Placebo versus DEN 15 mg for FPG \<7mmol/L. A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||4.62|0.26|0.906
72488082|NCT00111800|144504925|SUPERIORITY||Odds Ratio (OR)|1.56||||0.509|TWO_SIDED|95.0|0.41|5.91|||Regression, Logistic|||Placebo versus DEN 30 mg for FPG \<7mmol/L. A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||5.91|0.41|0.509
72515152|NCT01337167|144561077|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 95% CI of the response rate difference is \>= -10%|Response Rate Difference (V419 - Ctrl)|-2.67|||<|0.001|TWO_SIDED|95.0|-7.27|2.23|||Miettinen and Nurminen|Response rate, response rate difference and p-value were stratified by brand of birth dose of Hepatitis B vaccine||||2.23|-7.27|<0.001
72403597|NCT03552575|144313089|SUPERIORITY||Mean Difference (Final Values)|-0.5||||0.46|TWO_SIDED|95.0|-2.0|0.9|||Regression, Linear|adjusted for randomized treatment, baseline value of the outcome, use of diuretics at baseline and time from randomization to cardiac MRI||||0.9|-2.0|0.46
72515153|NCT01337167|144561078|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 95% CI of the response rate difference is \>= -10%|Response Rate Difference (V419 - Ctrl)|4.05|||<|0.001|TWO_SIDED|95.0|0.23|8.28|||Miettinen and Nurminen|Response rate, response rate difference and p-value were stratified by brand of birth dose of Hepatitis B vaccine||||8.28|0.23|<0.001
72515154|NCT01337167|144561079|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 95% CI of the response rate difference is \>= -5%|Response Rate Difference (V419 - Ctrl)|1.76|||<|0.001|TWO_SIDED|95.0|0.85|3.59|||Miettinen and Nurminen|Response rate, response rate difference and p-value were stratified by brand of birth dose of Hepatitis B vaccine||||3.59|0.85|<0.001
72515155|NCT01337167|144561079|SUPERIORITY_OR_OTHER||Response Rate|100.0|||<|0.001|TWO_SIDED|95.0|99.54|100.0|||Clopper and Pearson|Acceptability requires that the lower bound of the 2-sided 95% CI of the response rate is \>=90||||100.00|99.54|<0.001
72515156|NCT01337167|144561080|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 95% CI of the response rate difference is \>= -5%|Response Rate Difference (V419 - Ctrl)|0.26|||<|0.001|TWO_SIDED|95.0|-0.22|1.42|||Miettinen and Nurminen|Response rate, response rate difference and p-value were stratified by brand of birth dose of Hepatitis B vaccine||||1.42|-0.22|<0.001
72515157|NCT01337167|144561080|SUPERIORITY_OR_OTHER||Response Rate|100.0|||<|0.001|TWO_SIDED|95.0|99.54|100.0|||Clopper and Pearson|Acceptability requires that the lower bound of the 2-sided 95% CI of the response rate is \>=90||||100.00|99.54|<0.001
72515158|NCT01337167|144561081|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 95% CI of the response rate difference is \>= -5%|Response Rate Difference (V419 - Ctrl)|0.25|||<|0.001|TWO_SIDED|95.0|-0.24|1.41|||Miettinen and Nurminen|Response rate, response rate difference and p-value were stratified by brand of birth dose of Hepatitis B vaccine||||1.41|-0.24|<0.001
72515159|NCT01337167|144561081|SUPERIORITY_OR_OTHER||Response Rate|100.0|||<|0.001|TWO_SIDED|95.0|99.53|100.0|||Clopper and Pearson|Acceptability requires that the lower bound of the 2-sided 95% CI of the response rate is \>=90||||100.00|99.53|<0.001
72515160|NCT01337167|144561082|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 2-sided 95% CI of the Geometric Mean Concentration (GMC) ratio is \>=0.67|GMC Ratio (V419/Control)|1.28|||<|0.001|TWO_SIDED|95.0|1.2|1.38|||ANCOVA|GMC, GMC ratio, and p-value were adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine||||1.38|1.20|<0.001
72515161|NCT01337167|144561083|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 2-sided 95% CI of the GMC ratio is \>=0.67|GMC Ratio (V419/Control)|0.64||||0.786|TWO_SIDED|95.0|0.59|0.7|||ANCOVA|GMC, GMC ratio, and p-value were adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine||||0.70|0.59|0.786
72515162|NCT01337167|144561084|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 2-sided 95% CI of the GMC ratio is \>=0.67|GMC Ratio (V419/Control)|0.83|||<|0.001|TWO_SIDED|95.0|0.73|0.95|||ANCOVA|GMC, GMC ratio, and p-value were adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine||||0.95|0.73|<0.001
72515163|NCT01337167|144561085|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 2-sided 95% CI of the GMC ratio is \>=0.67|GMC Ratio (V419/Control)|1.28|||<|0.001|TWO_SIDED|95.0|1.15|1.42|||ANCOVA|GMC, GMC ratio, and p-value were adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine||||1.42|1.15|<0.001
72515164|NCT01337167|144561086|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 95% CI of the response rate difference is \>= -10%|Response Rate Difference (V419 - Ctrl)|1.88|||<|0.001|TWO_SIDED|95.0|0.39|4.18|||Miettinen and Nurminen|Response rate, response rate difference and p-value were stratified by brand of birth dose of Hepatitis B vaccine||||4.18|0.39|<0.001
72515165|NCT01337167|144561087|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 95% CI of the response rate difference is \>= -10%|Response Rate Difference (V419 - Ctrl)|1.3|||<|0.001|TWO_SIDED|95.0|-1.67|4.78|||Miettinen and Nurminen|Response rate, response rate difference and p-value were stratified by brand of birth dose of Hepatitis B vaccine||||4.78|-1.67|<0.001
72515166|NCT01337167|144561088|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 95% CI of the response rate difference is \>= -10%|Response Rate Difference (V419 - Ctrl)|-0.41|||<|0.001|TWO_SIDED|95.0|-3.46|3.1|||Miettinen and Nurminen|Response rate, response rate difference and p-value were stratified by brand of birth dose of Hepatitis B vaccine||||3.10|-3.46|<0.001
72515167|NCT01337167|144561089|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 95% CI of the response rate difference is \>= -10%|Response Rate Difference (V419 - Ctrl)|6.18|||<|0.001|TWO_SIDED|95.0|3.26|9.78|||Miettinen and Nurminen|Response rate, response rate difference and p-value were stratified by brand of birth dose of Hepatitis B vaccine||||9.78|3.26|<0.001
72515168|NCT01337167|144561090|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 2-sided 95% CI of the GMC ratio is \>=0.67|GMC Ratio (V419/Control)|1.4|||<|0.001|TWO_SIDED|95.0|1.28|1.52|||ANCOVA|GMC, GMC ratio, and p-value were adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine||||1.52|1.28|<0.001
72515169|NCT01337167|144561091|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 2-sided 95% CI of the GMC ratio is \>=0.67|GMC Ratio (V419/Control)|1.0|||<|0.001|TWO_SIDED|95.0|0.91|1.1|||ANCOVA|GMC, GMC ratio, and p-value were adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine||||1.10|0.91|<0.001
72403598|NCT03552575|144313090|SUPERIORITY||Mean Difference (Final Values)|-1.5||||0.16|TWO_SIDED|95.0|-3.5|0.6|||Regression, Linear|Adjusted for randomized treatment, baseline value of the outcome, use of diuretics at baseline and time from randomization to cardiac MRI||||0.6|-3.5|0.16
72403599|NCT03552575|144313091|SUPERIORITY|||||||0.56|||||||Fisher Exact|||||||0.56
72568215|NCT04764630|144668020|OTHER|Treatment differences on the log-scale will be estimated for the PK parameters. Geometric mean ratio and 90% CIs will be obtained by exponentiation of the treatment effect and 90% CIs based on the log-transformed scale. Dose-proportionality will be concluded if the confidence interval includes 1. Dose-normalized comparisons were exploratory.|Geometric mean ratio|0.87||||0.12|TWO_SIDED|90.0|0.75|1.01|||Mixed Models Analysis|Dose-normalized comparisons were exploratory.|This compares results from the 4 naloxone dose arm (2 every 2.5 min) (numerator) with the 4 naloxone dose arm (1 every 2.5 min) (denominator).|Dose-adjusted values for Cmax will be calculated based on noncompartmental PK parameter results, normalized to per mg of naloxone administered. Using linear mixed-effects modeling, comparisons of log-transformed dose-adjusted PK parameters will be performed. Treatment will be a fixed effect. Participant will be included as a random effect on the intercept.||1.01|0.75|0.12
72568216|NCT04764630|144668021|OTHER|Treatment differences on the log-scale will be estimated for the PK parameters. Geometric mean ratio and 90% CIs will be obtained by exponentiation of the treatment effect and 90% CIs based on the log-transformed scale. Dose-proportionality will be concluded if the confidence interval includes 1. Dose-normalized comparisons were exploratory.|Geometric mean ratio|0.83||||0.002|TWO_SIDED|90.0|0.76|0.91|||Mixed Models Analysis|Dose-normalized comparisons were exploratory.|This compares results from the 4 naloxone dose arm (1 every 2.5 min) (numerator) with the 2 naloxone dose arm (1 every 2.5 min) (denominator).|Dose-adjusted values for AUC0-inf will be calculated based on noncompartmental PK parameter results, normalized to per mg of naloxone administered. Using linear mixed-effects modeling, comparisons of log-transformed dose-adjusted PK parameters will be performed. Treatment will be a fixed effect. Participant will be included as a random effect on the intercept.||0.91|0.76|0.002
72568217|NCT04764630|144668021|OTHER|Treatment differences on the log-scale will be estimated for the PK parameters. Geometric mean ratio and 90% CIs will be obtained by exponentiation of the treatment effect and 90% CIs based on the log-transformed scale. Dose-proportionality will be concluded if the confidence interval includes 1. Dose-normalized comparisons were exploratory.|Geometric mean ratio|0.75|||<|0.001|TWO_SIDED|90.0|0.7|0.81|||Mixed Models Analysis|Dose-normalized comparisons were exploratory.|This compares results from the 4 naloxone dose arm (2 every 2.5 min) (numerator) with the 2 naloxone dose arm (1 every 2.5 min) (denominator).|Dose-adjusted values for AUC0-inf will be calculated based on noncompartmental PK parameter results, normalized to per mg of naloxone administered. Using linear mixed-effects modeling, comparisons of log-transformed dose-adjusted PK parameters will be performed. Treatment will be a fixed effect. Participant will be included as a random effect on the intercept.||0.81|0.70|<0.001
72568218|NCT04764630|144668021|OTHER|Treatment differences on the log-scale will be estimated for the PK parameters. Geometric mean ratio and 90% CIs will be obtained by exponentiation of the treatment effect and 90% CIs based on the log-transformed scale. Dose-proportionality will be concluded if the confidence interval includes 1. Dose-normalized comparisons were exploratory.|Geometric mean ratio|0.91||||0.014|TWO_SIDED|90.0|0.85|0.97|||Mixed Models Analysis|Dose-normalized comparisons were exploratory.|This compares results from the 4 naloxone dose arm (2 every 2.5 min) (numerator) with the 4 naloxone dose arm (1 every 2.5 min) (denominator).|Dose-adjusted values for AUC0-inf will be calculated based on noncompartmental PK parameter results, normalized to per mg of naloxone administered. Using linear mixed-effects modeling, comparisons of log-transformed dose-adjusted PK parameters will be performed. Treatment will be a fixed effect. Participant will be included as a random effect on the intercept.||0.97|0.85|0.014
72568219|NCT04764630|144668022|OTHER|Treatment differences on the log-scale will be estimated for the PK parameters. Geometric mean ratio and 90% CIs will be obtained by exponentiation of the treatment effect and 90% CIs based on the log-transformed scale. Dose-proportionality will be concluded if the confidence interval includes 1. Dose-normalized comparisons were exploratory.|Geometric mean ratio|0.82||||0.001|TWO_SIDED|90.0|0.75|0.89|||Mixed Models Analysis|Dose-normalized comparisons were exploratory.|This compares results from the 4 naloxone dose arm (1 every 2.5 min) (numerator) with the 2 naloxone dose arm (1 every 2.5 min) (denominator).|Dose-adjusted values for AUC0-t will be calculated based on noncompartmental PK parameter results, normalized to per mg of naloxone administered. Using linear mixed-effects modeling, comparisons of log-transformed dose-adjusted PK parameters will be performed. Treatment will be a fixed effect. Participant will be included as a random effect on the intercept.||0.89|0.75|0.001
72568220|NCT04764630|144668022|OTHER|Treatment differences on the log-scale will be estimated for the PK parameters. Geometric mean ratio and 90% CIs will be obtained by exponentiation of the treatment effect and 90% CIs based on the log-transformed scale. Dose-proportionality will be concluded if the confidence interval includes 1. Dose-normalized comparisons were exploratory.|Geometric mean ratio|0.74|||<|0.001|TWO_SIDED|90.0|0.69|0.8|||Mixed Models Analysis|Dose-normalized comparisons were exploratory.|This compares results from the 4 naloxone dose arm (2 every 2.5 min) (numerator) with the 2 naloxone dose arm (1 every 2.5 min) (denominator).|Dose-adjusted values for AUC0-t will be calculated based on noncompartmental PK parameter results, normalized to per mg of naloxone administered. Using linear mixed-effects modeling, comparisons of log-transformed dose-adjusted PK parameters will be performed. Treatment will be a fixed effect. Participant will be included as a random effect on the intercept.||0.80|0.69|<0.001
72568221|NCT04764630|144668022|OTHER|Treatment differences on the log-scale will be estimated for the PK parameters. Geometric mean ratio and 90% CIs will be obtained by exponentiation of the treatment effect and 90% CIs based on the log-transformed scale. Dose-proportionality will be concluded if the confidence interval includes 1. Dose-normalized comparisons were exploratory.|Geometric mean ratio|0.91||||0.014|TWO_SIDED|90.0|0.85|0.96|||Mixed Models Analysis|Dose-normalized comparisons were exploratory.|This compares results from the 4 naloxone dose arm (2 every 2.5 min) (numerator) with the 4 naloxone dose arm (1 every 2.5 min) (denominator).|Dose-adjusted values for AUC0-t will be calculated based on noncompartmental PK parameter results, normalized to per mg of naloxone administered. Using linear mixed-effects modeling, comparisons of log-transformed dose-adjusted PK parameters will be performed. Treatment will be a fixed effect. Participant will be included as a random effect on the intercept.||0.96|0.85|0.014
72577105|NCT00580788|144680819|NON_INFERIORITY_OR_EQUIVALENCE|The study was designed as a standard dose-escalation study, dose-finding pilot study. The primary outcome measures were safety (hypercalcemia, hypophosphatemia and symptoms/hemodynamic measurements). A modified Fibronacci dose-escalation scheme was employed.||||||0.01|TWO_SIDED|||||the reported p-value corresponds to % change from baseline at the follow-up visit in all Arms/groups|Mixed Models Analysis|The level of statistical significance was set at .05 (two-tailed)||||||0.01
72488083|NCT00111800|144504925|SUPERIORITY||Odds Ratio (OR)|3.14||||0.077|TWO_SIDED|95.0|0.89|11.14|||Regression, Logistic|||Placebo versus DEN 45 mg for FPG \<7mmol/L. A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||11.14|0.89|0.077
72488084|NCT00111800|144504925|SUPERIORITY||Odds Ratio (OR)|1.9||||0.254|TWO_SIDED|95.0|0.63|5.72|||Regression, Logistic|||Placebo versus DEN 2.5 mg for FPG reduction \>=1.7 mmol/L. A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||5.72|0.63|0.254
72488085|NCT00111800|144504925|SUPERIORITY||Odds Ratio (OR)|1.59||||0.396|TWO_SIDED|95.0|0.55|4.62|||Regression, Logistic|||Placebo versus DEN 7.5 mg for FPG reduction \>=1.7 mmol/L. A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||4.62|0.55|0.396
72515170|NCT01337167|144561092|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 2-sided 95% CI of the GMC ratio is \>=0.67|GMC Ratio (V419/Control)|0.78||||0.014|TWO_SIDED|95.0|0.68|0.89|||ANCOVA|GMC, GMC ratio, and p-value were adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine||||0.89|0.68|0.014
72515171|NCT01337167|144561093|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 2-sided 95% CI of the GMC ratio is \>=0.67|GMC Ratio (V419/Control)|1.58|||<|0.001|TWO_SIDED|95.0|1.41|1.78|||ANCOVA|GMC, GMC ratio, and p-value were adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine||||1.78|1.41|<0.001
72403600|NCT02404350|144313092|SUPERIORITY||Odds Ratio (OR)|4.02|||<|0.0001|TWO_SIDED|95.0|2.78|5.79|||Regression, Logistic|||Statistical values were calculated from a logistic regression model with treatment and randomization stratum (TNF-a status -naive or Incidence Rate) as factors and baseline weight as a covariate.||5.79|2.78|<0.0001
72403601|NCT02404350|144313092|SUPERIORITY||Odds Ratio (OR)|3.38|||<|0.0001|TWO_SIDED|95.0|2.35|4.87|||Regression, Logistic|||Statistical values were calculated from a logistic regression model with treatment and randomization stratum (TNF-a status -naive or Incidence Rate) as factors and baseline weight as a covariate.||4.87|2.35|<0.0001
72488086|NCT00111800|144504925|SUPERIORITY||Odds Ratio (OR)|1.35||||0.59|TWO_SIDED|95.0|0.45|4.0|||Regression, Logistic|||Placebo versus DEN 15 mg for FPG reduction \>=1.7 mmol/L. A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||4.00|0.45|0.590
72488087|NCT00111800|144504925|SUPERIORITY||Odds Ratio (OR)|3.24||||0.026|TWO_SIDED|95.0|1.15|9.13|||Regression, Logistic|||Placebo versus DEN 30 mg for FPG reduction \>=1.7 mmol/L. A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||9.13|1.15|0.026
72488088|NCT00111800|144504925|SUPERIORITY||Odds Ratio (OR)|3.0||||0.034|TWO_SIDED|95.0|1.08|8.3|||Regression, Logistic|||Placebo versus DEN 45 mg for FPG reduction \>=1.7 mmol/L. A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||8.30|1.08|0.034
72515172|NCT01337167|144561094|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 2-sided 95% CI of the GMC ratio is \>=0.67|GMC Ratio (V419/Control)|1.62|||<|0.001|TWO_SIDED|95.0|1.32|1.98|||ANCOVA|GMC, GMC ratio, and p-value were adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine||||1.98|1.32|<0.001
72515173|NCT01337167|144561095|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 2-sided 95% CI of the GMC ratio is \>=0.67|GMC Ratio (V419/Control)|1.02|||<|0.001|TWO_SIDED|95.0|0.83|1.24|||ANCOVA|GMC, GMC ratio, and p-value were adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine||||1.24|0.83|<0.001
72515174|NCT01337167|144561099|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.1|||||TWO_SIDED|95.0|-18.4|-7.7|||||Mean Difference is V419 - Control. The 95% confidence intervals were based on the unstratified Miettinen and Nurminen method.|Estimated difference, all routes \<38°C||-7.7|-18.4|
72488089|NCT00111800|144504926|SUPERIORITY||Mean Difference (Net)|-14.9||||0.057||95.0|-30.2|0.5|||ANCOVA||The point estimate was calculated as least square mean difference (net values) of placebo and DEN 2.5 mg.|A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||0.5|-30.2|0.057
72515175|NCT01337167|144561099|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.1|||||TWO_SIDED|95.0|0.5|9.5|||||Mean Difference is V419 - Control. The 95% confidence intervals were based on the unstratified Miettinen and Nurminen method.|Estimated difference, all routes \>=38°C and \<38.5°C||9.5|0.5|
72515176|NCT01337167|144561099|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.1|||||TWO_SIDED|95.0|2.8|11.2|||||Mean Difference is V419 - Control. The 95% confidence intervals were based on the unstratified Miettinen and Nurminen method.|Estimated difference, all routes \>=38.5°C and \<39.5°C||11.2|2.8|
72515177|NCT01337167|144561099|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.9|||||TWO_SIDED|95.0|-0.6|2.2|||||Mean Difference is V419 - Control. The 95% confidence intervals were based on the unstratified Miettinen and Nurminen method.|Estimated difference, all routes \>=39.5°C||2.2|-0.6|
72515178|NCT01337167|144561099|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.2|||||TWO_SIDED|95.0|-18.6|-7.7|||||Mean Difference is V419 - Control. The 95% confidence intervals were based on the unstratified Miettinen and Nurminen method.|Estimated difference, rectal \<38°C||-7.7|-18.6|
72515179|NCT01337167|144561099|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.5|||||TWO_SIDED|95.0|1.9|10.8|||||Mean Difference is V419 - Control. The 95% confidence intervals were based on the unstratified Miettinen and Nurminen method.|Estimated difference, rectal \>=38°C and \<38.5°C||10.8|1.9|
72403602|NCT02404350|144313092|SUPERIORITY||Odds Ratio (OR)|4.58|||<|0.0001|TWO_SIDED|95.0|3.16|6.63|||Regression, Logistic|||Statistical values were calculated from a logistic regression model with treatment and randomization stratum (TNF-a status -naive or Incidence Rate) as factors and baseline weight as a covariate.||6.63|3.16|<0.0001
72488090|NCT00111800|144504926|SUPERIORITY||Mean Difference (Net)|-22.4||||0.003||95.0|-37.1|-7.6|||ANCOVA||The point estimate was calculated as least square mean difference (net values) of placebo and DEN 7.5 mg.|A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||-7.6|-37.1|0.003
72488091|NCT00111800|144504926|SUPERIORITY||Mean Difference (Net)|-29.2|||<|0.001||95.0|-43.9|-14.5|||ANCOVA||The point estimate was calculated as least square mean difference (net values) of placebo and DEN 15 mg.|A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||-14.5|-43.9|<0.001
72488092|NCT00111800|144504926|SUPERIORITY||Mean Difference (Net)|-39.6|||<|0.001|TWO_SIDED|95.0|-54.6|-24.6|||ANCOVA||The point estimate was calculated as least square mean difference (net values) of placebo and DEN 30 mg.|A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||-24.6|-54.6|<0.001
72515180|NCT01337167|144561099|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.7|||||TWO_SIDED|95.0|2.4|10.7|||||Mean Difference is V419 - Control. The 95% confidence intervals were based on the unstratified Miettinen and Nurminen method.|Estimated difference, rectal \>=38.5°C and \<39.5°C||10.7|2.4|
72515181|NCT01337167|144561099|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.2|||||TWO_SIDED|95.0|-0.3|2.4|||||Mean Difference is V419 - Control. The 95% confidence intervals were based on the unstratified Miettinen and Nurminen method.|Estimated difference, rectal \>=39.5°C||2.4|-0.3|
72542484|NCT00106028|144614699|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-11.678||||0.0318||95.0|-22.325|-1.031|||ANCOVA|LS means and p-value are from ANCOVA model adjusted by baseline and fixed effects for age group, treatment and pooled center for post-baseline.||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.||-1.031|-22.325|0.0318
72568222|NCT00899470|144668032|NON_INFERIORITY_OR_EQUIVALENCE|If no difference between bioavailabilities of saxagliptin from FDC tablet vs. co-administration of saxagliptin tablet and metformin (fasted condition), then 20 subjects provided 97% power to conclude BE with respect to Cmax of saxagliptin. If 5% difference then 20 subjects provided 93% power to conclude BE with respect to Cmax of saxagliptin.|Geometric Mean Ratio, Test vs. Reference|1.011|||||TWO_SIDED|90.0|0.94|1.088|||Mixed Models Analysis|Bioequivalence=90% confidence intervals (CIs) for the test|For Cmax of saxagliptin, the point estimate and 90% CI were calculated for the ratio of the geometric mean of the Test formulation in fasted state: the geometric mean of the Reference formulation in fasted state|To demonstrate bioequivalence (BE) of FDC tablets (Test) versus co-administration of saxagliptin and metformin IR tablets (Reference) formulations in fasted state, linear mixed model analysis was performed on log(Cmax) of saxagliptin. Factors in the model were sequence, period and treatment as fixed effects, and participant within sequence as a random effect.||1.088|0.940|
72568223|NCT00899470|144668032|NON_INFERIORITY_OR_EQUIVALENCE|If no difference between bioavailabilities of saxagliptin from FDC tablet vs. co-administration of saxagliptin tablet and metformin (fed condition), then 20 subjects provided 97% power to conclude BE with respect to Cmax of saxagliptin. If 5% difference then 20 subjects provided 93% power to conclude BE with respect to Cmax of saxagliptin.|Geometric Mean Ratio, Test vs Reference|0.999|||||TWO_SIDED|90.0|0.929|1.075||||Bioequivalence=90% CIs for the test|For Cmax of saxagliptin, the point estimate and 90% CI were calculated for the ratio of the geometric mean of the Test formulation in fed state: the geometric mean of the Reference formulation in fed state|To demonstrate BE of FDC tablets (Test) versus co-administration of saxagliptin and metformin IR tablets (Reference) formulations in fed state, linear mixed model analysis was performed on log(Cmax) of saxagliptin. Factors in the model were sequence, period and treatment as fixed effects, and participant within sequence as a random effect.||1.075|0.929|
72568224|NCT00899470|144668033|NON_INFERIORITY_OR_EQUIVALENCE|If no difference between bioavailabilities of saxagliptin from FDC tablet vs. co-administration of saxagliptin tablet and metformin (fasted condition), then 20 subjects provided 99% power to conclude BE with respect to AUC(INF) of saxagliptin. If 5% difference then 20 subjects provided 99% power to conclude BE with respect to AUC(INF) of saxagliptin.|Geometric Mean Ratio, Test vs. Reference|1.029|||||TWO_SIDED|90.0|0.993|1.066|||Mixed Models Analysis|Bioequivalence=90% CIs for the test|For AUC(0-T) of saxagliptin, the point estimate and 90% CI were calculated for the ratio of the geometric mean of the Test formulation in fasted state: geometric mean of the Reference formulation in fasted state|To demonstrate BE of FDC tablets (Test) versus co-administration of saxagliptin and metformin IR tablets (Reference) formulations in fasted and fed states, linear mixed model analysis was performed on log\[AUC(0-T)\] of saxagliptin. Factors in the model were sequence, period and treatment as fixed effects, and participant within sequence as a random effect.||1.066|0.993|
72568225|NCT00899470|144668033|NON_INFERIORITY_OR_EQUIVALENCE|If no difference between bioavailabilities of saxagliptin from FDC tablet vs. co-administration of saxagliptin tablet and metformin (fed condition), then 20 subjects provided 99% power to conclude BE with respect to AUC(INF) of saxagliptin. If 5% difference then 20 subjects provided 99% power to conclude BE with respect to AUC(INF) of saxagliptin.|Geometric Means Ratio|1.021|||||TWO_SIDED|90.0|0.986|1.058|||Mixed Models Analysis|Bioequivalence=90% CIs for the test|For AUC(0-T) of saxagliptin, the point estimate and 90% CI were calculated for the ratio of the geometric mean of the Test formulation in fed state: the geometric mean of the Reference formulation in fed state|To demonstrate BE of FDC tablets (Test) versus co-administration of saxagliptin and metformin IR tablets (Reference) formulations in fed state, linear mixed model analysis was performed on log\[AUC(0-T)\] of saxagliptin. Factors in the model were sequence, period and treatment as fixed effects, and participant within sequence as a random effect.||1.058|0.986|
72488093|NCT00111800|144504926|SUPERIORITY||Mean Difference (Net)|-38.9|||<|0.001|TWO_SIDED|95.0|-53.8|-23.9|||ANCOVA||The point estimate was calculated as least square mean difference (net values) of placebo and DEN 45 mg.|A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||-23.9|-53.8|<0.001
72403603|NCT02404350|144313093|SUPERIORITY||Difference in Mean|-0.61|STANDARD_ERROR_OF_MEAN|0.22||0.0061|TWO_SIDED||||||Non-parametric ANCOVA model||\*For the Statistical Test of the Hypothesis for the Secondary Outcome, The Estimation Parameter is the Standard Error of the Difference in Mean and not Standard Error of the Mean|Secukinumab 300 mg With Load compared to Placebo Estimate (for the difference in mean), SE and p-value are from a non-parametric ANCOVA model (Koch, 1998) with the change from baseline van der Heijde total modified Sharp score (or Erosion Score or Joint Space Narrowing Score) as the dependent variable, treatment and randomization stratum (TNFa status -naive or IR ) as factors, and weight and baseline van der Heijde total modified Sharp score as covariates.||||0.0061
72403604|NCT02404350|144313093|SUPERIORITY||Difference in Mean|-0.36|STANDARD_ERROR_OF_MEAN|0.13||0.0048|TWO_SIDED||||||Non-parametric ANCOVA model||\*For the Statistical Test of the Hypothesis for the Secondary Outcome, The Estimation Parameter is the Standard Error of the Difference in Mean and not Standard Error of the Mean|Secukinumab 300 mg With Load compared to Placebo Estimate (for the difference in mean), SE and p-value are from a non-parametric ANCOVA model (Koch, 1998) with the change from baseline van der Heijde total modified Sharp score (or Erosion Score or Joint Space Narrowing Score) as the dependent variable, treatment and randomization stratum (TNFa status -naive or IR ) as factors, and weight and baseline van der Heijde total modified Sharp score as covariates.||||0.0048
72403605|NCT02404350|144313093|SUPERIORITY||Difference in Mean|-0.48|STANDARD_ERROR_OF_MEAN|0.13||0.0003|||||||Non-parametric ANCOVA model||For the Statistical Test of the Hypothesis for the Secondary Outcome, The Estimation Parameter is the Standard Error of the Difference in Mean and not Standard Error of the Mean|Secukinumab 300 mg With Load compared to Placebo Estimate (for the difference in mean), SE and p-value are from a non-parametric ANCOVA model (Koch, 1998) with the change from baseline van der Heijde total modified Sharp score (or Erosion Score or Joint Space Narrowing Score) as the dependent variable, treatment and randomization stratum (TNFa status -naive or IR ) as factors, and weight and baseline van der Heijde total modified Sharp score as covariates.||||0.0003
72403606|NCT02404350|144313094|SUPERIORITY||Odds Ratio (OR)|10.15|||<|0.0001|TWO_SIDED|95.0|5.52|18.63|||Regression, Logistic|||Odds ratio, 95% confidence interval, and p-value are from a logistic regression model with treatment and randomization stratum (TNF-alpha status -naïve or IR) as factors and baseline weight as a covariate.||18.63|5.52|<0.0001
72403607|NCT02404350|144313094|SUPERIORITY||Odds Ratio (OR)|11.66|||<|0.0001|TWO_SIDED|95.0|6.37|21.37|||Regression, Logistic|||Odds ratio, 95% confidence interval, and p-value are from a logistic regression model with treatment and randomization stratum (TNF-alpha status -naïve or IR) as factors and baseline weight as a covariate.||21.37|6.37|<0.0001
72403608|NCT02404350|144313094|SUPERIORITY||Odds Ratio (OR)|18.06|||<|0.0001|TWO_SIDED|95.0|9.56|34.12|||Regression, Logistic|||Odds ratio, 95% confidence interval, and p-value are from a logistic regression model with treatment and randomization stratum (TNF-alpha status -naïve or IR) as factors and baseline weight as a covariate.||34.12|9.56|<0.0001
72403609|NCT02404350|144313095|SUPERIORITY||Odds Ratio (OR)|4.51|||<|0.0001|TWO_SIDED|95.0|2.31|8.83|||Regression, Logistic|||"Odds ratio, 95% confidence interval, and p-value are from a logistic regression model with treatment and randomization stratum (TNF-alpha status -naïve or IR) as factors and baseline weight as a covariate.~Missing responses are imputed as non-responders."||8.83|2.31|<0.0001
72488094|NCT00111800|144504928|SUPERIORITY||Mean Difference (Net)|-8.51||||0.489|TWO_SIDED|95.0|-32.66|15.65|||ANCOVA||The point estimate was calculated as least square mean difference (net values) of placebo and DEN 2.5 mg for fasting serum insulin.|Placebo versus DEN 2.5 mg for fasting serum insulin. A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||15.65|-32.66|0.489
72488095|NCT00111800|144504928|SUPERIORITY||Mean Difference (Net)|14.18||||0.237|TWO_SIDED|95.0|-9.37|37.72|||ANCOVA||The point estimate was calculated as least square mean difference (net values) of placebo and DEN 7.5 mg for fasting serum insulin.|Placebo versus DEN 7.5 mg for fasting serum insulin. A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||37.72|-9.37|0.237
72488096|NCT00111800|144504928|SUPERIORITY||Mean Difference (Net)|7.31||||0.534||95.0|-15.79|30.42|||ANCOVA||The point estimate was calculated as least square mean difference (net values) of placebo and DEN 15 mg for fasting serum insulin.|Placebo versus DEN 15 mg for fasting serum insulin. A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||30.42|-15.79|0.534
72488097|NCT00111800|144504928|SUPERIORITY||Mean Difference (Net)|5.27||||0.665|TWO_SIDED|95.0|-18.64|29.17|||ANCOVA||The point estimate was calculated as least square mean difference (net values) of placebo and DEN 30 mg for fasting serum insulin.|Placebo versus DEN 30 mg for fasting serum insulin. A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||29.17|-18.64|0.665
72568226|NCT00899470|144668034|NON_INFERIORITY_OR_EQUIVALENCE|If no difference between bioavailabilities of saxagliptin from FDC tablet vs. co-administration of saxagliptin tablet and metformin (fasted condition), then 20 subjects provided 99% power to conclude BE with respect to AUC(INF) of saxagliptin. If 5% difference then 20 subjects provided 99% power to conclude BE with respect to AUC(INF) of saxagliptin.|Geometric Mean Ratio, Test vs. Reference|1.027|||||TWO_SIDED|90.0|0.99|1.066|||Mixed Models Analysis|Bioequivalence=90% CIs for the test|For AUC(INF) of saxagliptin, the point estimate and 90% CI were calculated for the ratio of the geometric mean of the Test formulation in fasted state: geometric mean of the Reference formulation in fasted state|To demonstrate BE of FDC tablets (Test) versus co-administration of saxagliptin and metformin IR tablets (Reference) formulations in fasted state, linear mixed model analysis was performed on log\[AUC(INF)\] of saxagliptin. Factors in the model were sequence, period and treatment as fixed effects, and participant within sequence as a random effect.||1.066|0.990|
72403610|NCT02404350|144313095|SUPERIORITY||Odds Ratio (OR)|6.14|||<|0.0001|TWO_SIDED|95.0|3.18|11.87|||Regression, Logistic|||"Odds ratio, 95% confidence interval, and p-value are from a logistic regression model with treatment and randomization stratum (TNF-alpha status -naïve or IR) as factors and baseline weight as a covariate.~Missing responses are imputed as non-responders."||11.87|3.18|<0.0001
72403611|NCT02404350|144313095|SUPERIORITY||Odds Ratio (OR)|12.55|||<|0.0001|TWO_SIDED|95.0|6.43|24.48|||Regression, Logistic|||"Odds ratio, 95% confidence interval, and p-value are from a logistic regression model with treatment and randomization stratum (TNF-alpha status -naïve or IR) as factors and baseline weight as a covariate.~Missing responses are imputed as non-responders."||24.48|6.43|<0.0001
72488098|NCT00111800|144504928|SUPERIORITY||Mean Difference (Net)|12.74||||0.295|TWO_SIDED|95.0|-11.18|36.65|||ANCOVA||The point estimate was calculated as least square mean difference (net values) of placebo and DEN 45 mg for fasting serum insulin.|Placebo versus DEN 45 mg for fasting serum insulin. A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||36.65|-11.18|0.295
72488099|NCT00111800|144504928|SUPERIORITY||Mean Difference (Net)|3.31||||0.327|TWO_SIDED|95.0|-3.32|9.94|||ANCOVA||The point estimate was calculated as least square mean difference (net values) of placebo and DEN 2.5 mg for pro-insulin.|Placebo versus DEN 2.5 mg for pro-insulin. A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||9.94|-3.32|0.327
72488100|NCT00111800|144504928|SUPERIORITY||Mean Difference (Net)|3.06||||0.345|TWO_SIDED|95.0|-3.31|9.44|||ANCOVA||The point estimate was calculated as least square mean difference (net values) of placebo and DEN 7.5 mg for pro-insulin.|Placebo versus DEN 7.5 mg for pro-insulin. A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||9.44|-3.31|0.345
72488101|NCT00111800|144504928|SUPERIORITY||Mean Difference (Net)|-0.35||||0.914|TWO_SIDED|95.0|-6.7|6.0|||ANCOVA||The point estimate was calculated as least square mean difference (net values) of placebo and DEN 15 mg for pro-insulin.|Placebo versus DEN 15 mg for pro-insulin. A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||6.00|-6.70|0.914
72488102|NCT00111800|144504928|SUPERIORITY||Mean Difference (Net)|-2.21||||0.504|TWO_SIDED|95.0|-8.71|4.29|||ANCOVA||The point estimate was calculated as least square mean difference (net values) of placebo and DEN 30 mg for pro-insulin.|Placebo versus DEN 30 mg for pro-insulin. A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||4.29|-8.71|0.504
72515182|NCT00884221|144561124|NON_INFERIORITY_OR_EQUIVALENCE|The null hypothesis (H0) was tested against the alternative by constructing a two-sided 95% confidence interval for the difference in ongoing pregnancy rates. If the lower-limit of the 95% confidence interval was greater than the non-inferiority limit (-10.0%), the null hypothesis was rejected and it would be claimed that highly purified menotrophin was non-inferior to recombinant FSH with respect to ongoing pregnancy rate in a single fresh treatment cycle following a GnRH antagonist protocol.|Difference in pregnancy rates, ITT|2.2||||0.499|TWO_SIDED|95.0|-4.2|8.6||Since there was only one primary endpoint, no adjustment for multiplicity was needed for the primary analysis.|Sign test|A two-sided 95% confidence interval for the difference in ongoing pregnancy rates was made. The CI was based on a normal approximation.|Difference tested: highly purified menotrophin-recombinant FSH, ITT analysis set|"The non-inferiority hypothesis to be tested for the primary endpoint was:~H0: π MENOPUR - π recombinant FSH ≤ -10.0% against the alternative H1: π MENOPUR - π recombinant FSH \> -10.0%,~where π MENOPUR and π recombinant FSH denote the ongoing pregnancy rate after treatment with MENOPUR and recombinant FSH, respectively, in a single fresh treatment cycle following a GnRH antagonist protocol."||8.6|-4.2|0.499
72515183|NCT00884221|144561125|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Regression, Linear|Tests for treatment differences were based on log-transformed values and adjusted for baseline values||Estradiol||||<0.001
72515184|NCT00884221|144561126|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Regression, Linear|Tests for treatment differences were based on log-transformed values and adjusted for baseline values||FSH||||<0.001
72515185|NCT00884221|144561127|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Regression, Linear|Tests for treatment differences were based on log-transformed values and adjusted for baseline values||Free Androgen Index||||<0.001
72515186|NCT00884221|144561128|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Regression, Linear|Tests for treatment differences were based on log-transformed values and adjusted for baseline values||Luteinizing hormone||||<0.001
72515187|NCT00884221|144561129|SUPERIORITY_OR_OTHER|||||||0.63||95.0|||||Regression, Linear|Tests for treatment differences were based on log-transformed values and adjusted for baseline values||Progesterone||||0.630
72542485|NCT00106028|144614700|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.067||||0.9907|TWO_SIDED|95.0|-11.401|11.536|||ANCOVA|LS means and p-value are from ANCOVA model adjusted by baseline and fixed effects for age group, treatment and pooled center for post-baseline.||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.||11.536|-11.401|0.9907
72488103|NCT00111800|144504928|SUPERIORITY||Mean Difference (Net)|2.75||||0.403|TWO_SIDED|95.0|-3.71|9.22|||ANCOVA||The point estimate was calculated as least square mean difference (net values) of placebo and DEN 45 mg for pro-insulin.|Placebo versus DEN 45 mg for pro-insulin. A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||9.22|-3.71|0.403
72577106|NCT00580788|144680820|NON_INFERIORITY_OR_EQUIVALENCE|The study was designed as a standard dose-escalation study, dose-finding pilot study. The primary outcome measures were safety (hypercalcemia, hypophosphatemia and symptoms/hemodynamic measurements). A modified Fibronacci dose-escalation scheme was employed.||||||0.001|TWO_SIDED|||||the reported p-value correspond to the decrease compared to baseline over time in the PTHrP 4 pmol group.|Mixed Models Analysis|The level of statistical significance was set at .05 (two-tailed)||||||0.001
72403612|NCT02404350|144313096|SUPERIORITY||Odds Ratio, log|5.37|||<|0.0001|TWO_SIDED|95.0|3.3|8.73|||Regression, Logistic|||Odds ratio, 95% confidence interval, and p-value are from a logistic regression model with treatment and randomization stratum (TNF-alpha status -naïve or IR) as factors and baseline weight as a covariate.||8.73|3.30|<0.0001
72403613|NCT02404350|144313096|SUPERIORITY||Odds Ratio (OR)|6.37|||<|0.0001|TWO_SIDED|95.0|3.93|10.32|||Regression, Logistic|||Odds ratio, 95% confidence interval, and p-value are from a logistic regression model with treatment and randomization stratum (TNF-alpha status -naïve or IR) as factors and baseline weight as a covariate.||10.32|3.93|<0.0001
72403614|NCT02404350|144313096|SUPERIORITY||Odds Ratio (OR)|7.43|||<|0.0001|TWO_SIDED|95.0|4.61|12.0|||Regression, Logistic|||Odds ratio, 95% confidence interval, and p-value are from a logistic regression model with treatment and randomization stratum (TNF-alpha status -naïve or IR) as factors and baseline weight as a covariate.||12.00|4.61|<0.0001
72403615|NCT02404350|144313097|SUPERIORITY|Mixed model with treatment regimen, analysis visit and randomization stratum (TNF-alpha status -naïve or IR) as factors, weight and baseline score as continuous covariates, and treatment by analysis visit and baseline score by analysis visit as interaction terms, using an unstructured covariance structure|Treatment contrast in LS mean (Change)|-0.24|STANDARD_ERROR_OF_MEAN|0.045|<|0.0001|TWO_SIDED|95.0|-0.32|-0.15|||Mixed Models Analysis|LS Mean, 95% confidence interval, and p-value are from a mixed model for repeated measures (MMRM)||||-0.15|-0.32|<0.0001
72515188|NCT00884221|144561130|NON_INFERIORITY_OR_EQUIVALENCE|The null hypothesis (H0) was tested against the alternative by constructing a two-sided 95% confidence interval for the difference in ongoing pregnancy rates. If the lower-limit of the 95% confidence interval was greater than the non-inferiority limit (-10.0%), the null hypothesis was rejected and it would be claimed that highly purified menotrophin was non-inferior to recombinant FSH with respect to ongoing pregnancy rate in a single fresh treatment cycle following a GnRH antagonist protocol.|Difference in pregnancy rates, PP|3.0||||0.387|TWO_SIDED|95.0|-3.8|9.8||Since there was only one primary endpoint, no adjustment for multiplicity was needed for the primary analysis.|Sign test|A two-sided 95% confidence interval for the difference in ongoing pregnancy rates was made. The CI was based on a normal approximation.|Difference tested: highly purified menotrophin - recombinant FSH, PP|"The non-inferiority hypothesis to be tested for the primary endpoint was:~H0: π MENOPUR - π recombinant FSH ≤ -10.0% against the alternative H1: π MENOPUR - π recombinant FSH \> -10.0%,~where π MENOPUR and π recombinant FSH denote the ongoing pregnancy rate after treatment with MENOPUR and recombinant FSH, respectively, in a single fresh treatment cycle following a GnRH antagonist protocol."||9.8|-3.8|0.387
72515189|NCT00884221|144561131|SUPERIORITY_OR_OTHER|||||||0.047||95.0|||||Regression, Linear|Tests for treatment differences were based on log-transformed values and adjusted for baseline values||Prolactin||||0.047
72515190|NCT00884221|144561132|SUPERIORITY_OR_OTHER|||||||0.009||95.0|||||Regression, Linear|Tests for treatment differences were based on log-transformed values and adjusted for baseline values||Sex hormone binding globulin||||0.009
72515191|NCT00884221|144561133|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Regression, Linear|Tests for treatment differences were based on log-transformed values and adjusted for baseline values||Testosterone||||<0.001
72515192|NCT00884221|144561134|SUPERIORITY_OR_OTHER|||||||0.025||95.0|||||Wilcoxon (Mann-Whitney)|||Comparison between treatment groups of the average number of follicles \>= 12 mm on the last stimulation day||||0.025
72577107|NCT00580788|144680820|NON_INFERIORITY_OR_EQUIVALENCE|The study was designed as a standard dose-escalation study, dose-finding pilot study. The primary outcome measures were safety (hypercalcemia, hypophosphatemia and symptoms/hemodynamic measurements). A modified Fibronacci dose-escalation scheme was employed.||||||0.01|TWO_SIDED|||||the reported p=value corresponds to % change compared to baseline at follow-up in all Arms/groups|Mixed Models Analysis|The level of statistical significance was set at .05 (two-tailed)||||||.01
72624274|NCT00863304|144778627|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.13|STANDARD_ERROR_OF_MEAN|0.23|<|0.001|TWO_SIDED|95.0|-1.59|-0.67||P-value was based on pairwise comparisons.|ANCOVA|||Week 4: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.67|-1.59|<0.001
72403616|NCT02404350|144313097|SUPERIORITY||Treatment Contrast in LS mean (Change)|-0.23|STANDARD_ERROR_OF_MEAN|0.045|<|0.0001|TWO_SIDED|95.0|-0.32|-0.14|||Mixed Models Analysis|LS Mean, 95% confidence interval, and p-value are from a mixed model for repeated measures (MMRM)||||-0.14|-0.32|<0.0001
72515193|NCT00884221|144561134|SUPERIORITY_OR_OTHER|||||||0.024||95.0|||||Wilcoxon (Mann-Whitney)|||Comparison between treatment groups of the average number of follicles 12-14 mm on the last stimulation day||||0.024
72515194|NCT00884221|144561134|SUPERIORITY_OR_OTHER|||||||0.728||95.0|||||Wilcoxon (Mann-Whitney)|||Comparison between treatment groups of the average number of follicles 15-16 mm on the last stimulation day||||0.728
72515195|NCT00884221|144561134|SUPERIORITY_OR_OTHER|||||||0.285||95.0|||||Wilcoxon (Mann-Whitney)|||Comparison between treatment groups of the average number of follicles \>=17 mm on the last stimulation day||||0.285
72515196|NCT00884221|144561135|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon (Mann-Whitney)|Only participants who underwent the oocyte retrieval procedure were included in the analysis||Treatments were compared using the Wilcoxon test for the average number of oocytes retrieved.||||<0.001
72515197|NCT00884221|144561136|SUPERIORITY_OR_OTHER|||||||0.969||95.0|||||Wilcoxon (Mann-Whitney)|Only participants who had oocytes retrieved were included in the analysis.||||||0.969
72515198|NCT00884221|144561137|SUPERIORITY_OR_OTHER|||||||0.406||95.0|||||Wilcoxon (Mann-Whitney)|||Comparison between treatments groups of percentage of blastocysts with expansion and hatching status 1 / 2pn||||0.406
72515199|NCT00884221|144561137|SUPERIORITY_OR_OTHER|||||||0.232||95.0|||||Wilcoxon (Mann-Whitney)|||Comparison between treatments groups of percentage of blastocysts with expansion and hatching status 2 / 2pn||||0.232
72515200|NCT00884221|144561137|SUPERIORITY_OR_OTHER|||||||0.412||95.0|||||Wilcoxon (Mann-Whitney)|||Comparison between treatments groups of percentage of blastocysts with expansion and hatching status 3 / 2pn||||0.412
72515201|NCT00884221|144561137|SUPERIORITY_OR_OTHER|||||||0.438||95.0|||||Wilcoxon (Mann-Whitney)|||Comparison between treatments groups of percentage of blastocysts with expansion and hatching status 4 / 2pn||||0.438
72515202|NCT00884221|144561137|SUPERIORITY_OR_OTHER|||||||0.39||95.0|||||Wilcoxon (Mann-Whitney)|||Comparison between treatments groups of percentage of blastocysts with expansion and hatching status 5 / 2pn||||0.390
72515203|NCT00884221|144561137|SUPERIORITY_OR_OTHER|||||||0.958||95.0|||||Wilcoxon (Mann-Whitney)|||Comparison between treatments groups of percentage of blastocysts with expansion and hatching status, inner cell mass grading and trophectoderm grading 4AA / 2pn||||0.958
72515204|NCT00884221|144561137|SUPERIORITY_OR_OTHER|||||||0.954||95.0|||||Wilcoxon (Mann-Whitney)|||Comparison between treatments groups of percentage of blastocysts with expansion and hatching status, inner cell mass grading and trophectoderm grading 5AA / 2pn||||0.954
72624275|NCT00863304|144778627|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.91|STANDARD_ERROR_OF_MEAN|0.24|<|0.001|TWO_SIDED|95.0|-1.37|-0.45||P-value was based on pairwise comparisons.|ANCOVA|||Week 4: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.45|-1.37|<0.001
72624276|NCT00863304|144778627|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.59|STANDARD_ERROR_OF_MEAN|0.24||0.012|TWO_SIDED|95.0|-1.05|-0.13||P-value was based on pairwise comparisons.|ANCOVA|||Week 4: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.13|-1.05|0.012
72624277|NCT00863304|144778627|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.54|STANDARD_ERROR_OF_MEAN|0.24||0.023|TWO_SIDED|95.0|-1.0|-0.07||P-value was based on pairwise comparisons.|ANCOVA|||Week 4: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.07|-1.00|0.023
72488104|NCT00111800|144504931|SUPERIORITY||Mean Difference (Net)|0.03||||0.286|TWO_SIDED|95.0|-0.02|0.08|||ANCOVA||The point estimate was calculated as least square mean difference (net values) of placebo and DEN 2.5 mg.|A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||0.08|-0.02|0.286
72488105|NCT00111800|144504931|SUPERIORITY||Mean Difference (Net)|-0.02||||0.457|TWO_SIDED|95.0|-0.07|0.03|||ANCOVA||The point estimate was calculated as least square mean difference (net values) of placebo and DEN 7.5 mg.|A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||0.03|-0.07|0.457
72488106|NCT00111800|144504931|SUPERIORITY||Mean Difference (Net)|-0.04||||0.136|TWO_SIDED|95.0|-0.09|0.01|||ANCOVA||The point estimate was calculated as least square mean difference (net values) of placebo and DEN 15 mg.|A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||0.01|-0.09|0.136
72488107|NCT00111800|144504931|SUPERIORITY||Mean Difference (Net)|-0.06||||0.021|TWO_SIDED|95.0|-0.11|-0.01|||ANCOVA||The point estimate was calculated as least square mean difference (net values) of placebo and DEN 30 mg.|A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||-0.01|-0.11|0.021
72488108|NCT00111800|144504931|SUPERIORITY||Mean Difference (Net)|-0.04||||0.094|TWO_SIDED|95.0|-0.09|0.01|||ANCOVA||The point estimate was calculated as least square mean difference (net values) of placebo and DEN 45 mg.|A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||0.01|-0.09|0.094
72488109|NCT01549275|144504947|SUPERIORITY_OR_OTHER||||||<|0.005|TWO_SIDED||||||Chi-squared|degrees of freedom =1||Null hypothesis: There is no significant difference in the incidence of patients with rapidly proliferative cultured cells between two groups.||||< 0.005
72488110|NCT01549275|144504947|SUPERIORITY_OR_OTHER||||||<|0.005|TWO_SIDED||||||Chi-squared|degrees of freedom = 1||Null hypothesis: There is no significant difference in the incidence of patients with rapidly proliferative cultured HCC cells with or without concomitant cancer-associated fibroblasts between two groups.||||< 0.005
72488111|NCT01549275|144504947|SUPERIORITY_OR_OTHER||||||>|0.1|TWO_SIDED||||||Chi-squared|degrees of freedom = 1||Null hypothesis: There is no significant difference in the incidence of patients with rapidly proliferative cultured cancer-associated fibroblasts alone between two groups.||||> 0.1
72488112|NCT01549275|144504948|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Fisher Exact|degrees of freedom = 1||null hypothesis: There is no significant difference in the incidence of change in AJCC TNM stages and survivals 6 months after plating of cells between patients with rapidly and slowly proliferative cultured cells.||||1
72488113|NCT01549275|144504948|SUPERIORITY_OR_OTHER|||||||0.032|TWO_SIDED||||||Fisher Exact|degrees of freedom = 1||Null hypothesis: There is no significant difference in the incidence of change in AJCC TNM stages and survivals 6 months after plating of cells between patients with rapidly and slowly proliferative cultured cells.||||0.032
72488114|NCT01549275|144504948|SUPERIORITY_OR_OTHER|||||||0.048|TWO_SIDED||||||Fisher Exact|degrees of freedom = 1||Null hypothesis: There is no significant difference in the incidence of change in AJCC TNM stages and survivals 6 months after plating of cells between patients with rapidly and slowly proliferative cultured cells.||||0.048
72488115|NCT01549275|144504948|SUPERIORITY_OR_OTHER|||||||0.176|TWO_SIDED||||||Fisher Exact|degrees of freedom = 1||Null hypothesis: There is no significant difference in the incidence of change in AJCC TNM stages and survivals 6 months after plating of cells between patients with rapidly and slowly proliferative cultured cells.||||0.176
72488116|NCT01549275|144504948|SUPERIORITY_OR_OTHER|||||||0.021|TWO_SIDED||||||Fisher Exact|degrees of freedom = 1||Null hypothesis: There is no significant difference in the incidence of change in AJCC TNM stages and survivals 6 months after plating of cells between patients with rapidly and slowly proliferative HCC cultured cells.||||0.021
72488117|NCT01549275|144504948|SUPERIORITY_OR_OTHER|||||||0.129|TWO_SIDED||||||Fisher Exact|degrees of freedom = 1||Null hypothesis: There is no significant difference in the incidence of change in AJCC TNM stages and survivals 6 months after plating of cells between patients with rapidly and slowly proliferative cultured cells.||||0.129
72488118|NCT03448068|144504949|SUPERIORITY|||||||0.03|||||||Wilcoxon (Mann-Whitney)|||||||0.03
72488119|NCT03448068|144504950|SUPERIORITY|||||||0.2252|||||||t-test, 2 sided|||||||0.2252
72488120|NCT03448068|144504951|SUPERIORITY|||||||0.061|||||||t-test, 2 sided|||||||0.0610
72488121|NCT03448068|144504952|SUPERIORITY|||||||0.272|||||||t-test, 2 sided|||||||0.2720
72624278|NCT00863304|144778627|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.32|STANDARD_ERROR_OF_MEAN|0.24||0.175|TWO_SIDED|95.0|-0.78|0.14||P-value was based on pairwise comparisons.|ANCOVA|||Week 4: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||0.14|-0.78|0.175
72624279|NCT00863304|144778627|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.09|STANDARD_ERROR_OF_MEAN|0.24|<|0.001|TWO_SIDED|95.0|-1.55|-0.63||P-value was based on pairwise comparisons.|ANCOVA|||Week 8: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.63|-1.55|<0.001
72488122|NCT03448068|144504953|SUPERIORITY|||||||0.7298|||||||Chi-squared|||Nausea 1st 12 hours for Ketamine Therapy vs Standard Therapy||||0.7298
72488123|NCT03448068|144504953|SUPERIORITY|||||||0.1058|||||||Chi-squared|||Nausea 2nd 12 hours for Ketamine Therapy vs Standard Therapy||||0.1058
72488124|NCT03448068|144504953|SUPERIORITY|||||||1|||||||Chi-squared|||Nausea 2nd 24 hours for Ketamine Therapy vs Standard Therapy||||1.000
72488125|NCT03448068|144504954|SUPERIORITY|||||||0.2|||||||t-test, 2 sided|||||||0.2
72488126|NCT01111851|144504957|SUPERIORITY_OR_OTHER||Geometric Mean Ratio of the LS Means|1.0|||||TWO_SIDED|90.0|0.99|1.01|||||"The point estimate and 90% confidence interval (CI) were generated for the geometric mean ratio (GMR) \[aprepitant~165 mg/fosaprepitant 150 mg\]."|||1.01|0.99|
72488127|NCT01111851|144504958|SUPERIORITY_OR_OTHER||Geometric Mean Ratio of the LS means|1.0|||||TWO_SIDED|90.0|0.98|1.02|||||"The point estimate and 90% confidence interval (CI) were generated for the geometric mean ratio (GMR) \[aprepitant~165 mg/fosaprepitant 150 mg\]."|||1.02|0.98|
72488128|NCT01111851|144504959|SUPERIORITY_OR_OTHER||Geometric Mean Ratio of the LS means|1.0|||||TWO_SIDED|90.0|0.97|1.03|||||"The point estimate and 90% confidence interval (CI) were generated for the geometric mean ratio (GMR) \[aprepitant~165 mg/fosaprepitant 150 mg\]."|||1.03|0.97|
72488129|NCT01111851|144504960|SUPERIORITY_OR_OTHER||Geometric Mean Ratio of the LS means|0.91|||||TWO_SIDED|90.0|0.5|1.66|||||"The point estimate and 90% confidence interval (CI) were generated for the geometric mean ratio (GMR) \[aprepitant~165 mg/fosaprepitant 150 mg\]."|||1.66|0.50|
72515205|NCT00884221|144561138|SUPERIORITY_OR_OTHER||Comparison of distributions|0.398||||0.398|TWO_SIDED|95.0|-3.6|9.1|||Wilcoxon (Mann-Whitney)|A two-sided 95% confidence interval for the difference in live birth rates was made. The CI was based on a normal approximation.|Estimated value is difference between highly purified menotrophin and recombinant FSH, ITT analysis set|||9.1|-3.6|0.398
72403617|NCT02404350|144313097|SUPERIORITY||Treatment Contrast inj LS mean (Change)|-0.33|STANDARD_ERROR_OF_MEAN|0.045|<|0.0001|TWO_SIDED|95.0|-0.42|-0.24|||Mixed Models Analysis|LS Mean, 95% confidence interval, and p-value are from a mixed model for repeated measures (MMRM)||||-0.24|-0.42|<0.0001
72488130|NCT01471015|144504963|SUPERIORITY_OR_OTHER_LEGACY|||||||0.006|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.006
72488131|NCT01471015|144504964|SUPERIORITY_OR_OTHER_LEGACY|||||||0.003|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.003
72488132|NCT01843842|144504965|SUPERIORITY|||||||0.016|||||||Global Test Statistic|See O'Brien 1984, Pocock 1997.||||||0.016
72488133|NCT01843842|144504966|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||||||<0.0001
72488134|NCT01843842|144504967|SUPERIORITY||||||>|0.05|||||||Fisher Exact|||||||>0.05
72488135|NCT01843842|144504968|SUPERIORITY|||||||0.0283||||||p-value is not adjusted for multiple comparisons|Kruskal-Wallis|||Fever (Day 3, doctor's examination)||||0.0283
72488136|NCT01843842|144504968|SUPERIORITY|||||||0.3264|||||||Kruskal-Wallis|||Non-specific (Day 3, doctor's examination)||||0.3264
72488137|NCT01843842|144504968|SUPERIORITY|||||||0.706|||||||Kruskal-Wallis|||Nasal/Throat/Chest (Day 3, doctor's examination)||||0.7060
72488138|NCT01843842|144504968|SUPERIORITY|||||||0.25|||||||Kruskal-Wallis|||All symptoms (Day 3, doctor's examination)||||0.25
72488139|NCT01843842|144504968|SUPERIORITY|||||||0.244|||||||ANCOVA|||Severity of clinical manifestations of acute respiratory infection (ARI) by Total Symptom Score on Days 2, 3, 4 and 5 of Observation (Based on Patient Diary Data)||||0.244
72488140|NCT01843842|144504969|SUPERIORITY|||||||0.1158|||||||Kruskal-Wallis|||Duration of fever based on Patient Diary Data||||0.1158
72488141|NCT01843842|144504969|SUPERIORITY|||||||0.5755|||||||Kruskal-Wallis|||Duration of non-specific symptoms based on Patient Diary Data||||0.5755
72488142|NCT01843842|144504969|SUPERIORITY|||||||0.4331|||||||Kruskal-Wallis|||Duration of nasal/ throat/ chest symptoms based on Patient Diary Data||||0.4331
72488143|NCT01843842|144504969|SUPERIORITY|||||||0.356|||||||Kruskal-Wallis|||Duration of all acute respiratory infection symptoms (fever, non-specific symptoms and nasal/ throat/ chest symptoms) based on Patient Diary Data||||0.3560
72488144|NCT01843842|144504970|SUPERIORITY|||||||0.0166||||||p-value is not adjusted for multiple comparisons|Kruskal-Wallis|||Fever (Days 1, 3, 6 doctor's examination)||||0.0166
72488145|NCT01843842|144504970|SUPERIORITY|||||||0.082|||||||Kruskal-Wallis|||Non-specific (Days 1, 3, 6 doctor's examination)||||0.0820
72488146|NCT01843842|144504970|SUPERIORITY|||||||0.7227|||||||Kruskal-Wallis|||Nasal/Throat/Chest (Days 1, 3, 6 doctor's examination)||||0.7227
72488147|NCT01843842|144504970|SUPERIORITY|||||||0.2645|||||||Kruskal-Wallis|||All symptoms (Days 1, 3, 6 doctor's examination)||||0.2645
72488148|NCT01843842|144504970|SUPERIORITY|||||||0.0142||||||p-value is not adjusted for multiple comparisons|Kruskal-Wallis|||Fever (Days 1-5, patient diary data)||||0.0142
72488149|NCT01843842|144504970|SUPERIORITY|||||||0.0145||||||p-value is not adjusted for multiple comparisons|Kruskal-Wallis|||Non-specific (Days 1-5, patient diary data)||||0.0145
72488150|NCT01843842|144504970|SUPERIORITY|||||||0.2963|||||||Kruskal-Wallis|||Nasal/Throat/Chest (Days 1-5, patient diary data)||||0.2963
72488151|NCT01843842|144504970|SUPERIORITY|||||||0.0364||||||p-value is not adjusted for multiple comparisons|Kruskal-Wallis|||All symptoms (Days 1-5, patient diary data)||||0.0364
72488152|NCT01843842|144504971|SUPERIORITY|||||||0.4|||||||ANCOVA|||||||0.40
72488153|NCT02953340|144504973|NON_INFERIORITY|The study used non inferiority margin of 0.62 days for the above comparison. The non-inferiority of SPI-2012 to Pegfilgrastim was declared if the upper bound of 95% confidence interval (CI) of the difference in mean DSN between the treatment arms was \<0.62 days.|Mean difference|-0.074|||<|0.0001|TWO_SIDED|95.0|-0.292|0.129|||t-statistics|The p-values are based on the calculated t-statistics from the bootstrapped sample mean and standard deviation.||||0.129|-0.292|< 0.0001
72488154|NCT01376778|144504983|SUPERIORITY||Risk Ratio (RR)|1.17||||0.42|TWO_SIDED|95.0|0.8|1.72|||Chi-squared|||||1.72|0.80|0.42
72488155|NCT01376778|144504988|SUPERIORITY||Risk Ratio (RR)|1.61|||||TWO_SIDED|95.0|0.86|3.03||||||||3.03|0.86|
72488156|NCT01376778|144504989|SUPERIORITY||Risk Ratio (RR)|2.82|||||TWO_SIDED|95.0|0.29|72.42||||||||72.42|0.29|
72515206|NCT00884221|144561139|SUPERIORITY_OR_OTHER||Comparison of distributions|1.8||||0.686|TWO_SIDED|95.0|-5.6|9.2|||Wilcoxon (Mann-Whitney)|A two-sided 95% confidence interval for the difference in cumulative live birth rates was made. The CI was based on a normal approximation.|Estimated value is difference between highly purified menotrophin and recombinant FSH, ITT analysis set|||9.2|-5.6|0.686
72515207|NCT02757092|144561140|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<0.05
72515208|NCT02757092|144561141|SUPERIORITY||||||<|0.05|||||||ANOVA|||null hypothesis||||<0.05
72488157|NCT01376778|144504990|SUPERIORITY||Risk Difference (RD)|-0.41|||||TWO_SIDED|||||||||||||
72488158|NCT01376778|144504991|SUPERIORITY||Risk Ratio (RR)|1.47|||||TWO_SIDED|95.0|0.81|2.67||||||||2.67|0.81|
72488159|NCT01376778|144504992|SUPERIORITY||Risk Ratio (RR)|1.61|||||TWO_SIDED|95.0|0.65|4.01||||||||4.01|0.65|
72488160|NCT01376778|144504994|SUPERIORITY||Risk Ratio (RR)|1.88|||||TWO_SIDED|95.0|0.66|5.41||||||||5.41|0.66|
72488161|NCT01376778|144504995|SUPERIORITY||Risk Difference (RD)|-0.25|||||TWO_SIDED|95.0|-0.66|0.15||||||||0.15|-0.66|
72488162|NCT01376778|144504996|SUPERIORITY||Risk Difference (RD)|-35.0|||||TWO_SIDED|95.0|-157.0|87.0||||||||87|-157|
72488163|NCT01376778|144504997|SUPERIORITY||Risk Ratio (RR)|1.92|||||TWO_SIDED|95.0|0.92|3.99||||||||3.99|0.92|
72488164|NCT01376778|144505001|SUPERIORITY||Risk Ratio (RR)|0.94|||||TWO_SIDED|95.0|0.03|31.5||||||||31.5|0.03|
72488165|NCT01376778|144505002|SUPERIORITY||Risk Ratio (RR)|0.48|||||TWO_SIDED|95.0|0.17|1.38||||||||1.38|0.17|
72488166|NCT01376778|144505005|SUPERIORITY||Risk Ratio (RR)|0.63|||||TWO_SIDED|95.0|0.32|1.23||||||||1.23|0.32|
72488167|NCT01376778|144505006|SUPERIORITY||Risk Ratio (RR)|0.84|||||TWO_SIDED|95.0|0.42|1.68||||||||1.68|0.42|
72488168|NCT01376778|144505007|SUPERIORITY||Risk Ratio (RR)|0.47|||||TWO_SIDED|95.0|0.17|5.23||||||||5.23|0.17|
72488169|NCT01376778|144505015|SUPERIORITY||Risk Ratio (RR)|1.3||||0.37|TWO_SIDED|95.0|0.7|2.5|||Chi-squared|||||2.5|0.7|0.37
72488170|NCT01376778|144505016|SUPERIORITY|||||||0.26|||||||Chi-squared|||||||0.26
72488171|NCT01376778|144505017|SUPERIORITY|||||||0.84|||||||Chi-squared|||||||0.84
72488172|NCT01309659|144505069|SUPERIORITY_OR_OTHER|||||||0.308|TWO_SIDED|||||Correlation between ferritin and change in hemoglobin in the immediate intervention group. Testing the correlation equal to 0.|t-test, 2 sided|||||||0.308
72488173|NCT01309659|144505069|SUPERIORITY_OR_OTHER|||||||0.601|TWO_SIDED|||||Correlation between ferritin and change in hemoglobin in the waitlist group. Testing the correlation = 0.|t-test, 2 sided|||||||0.601
72488174|NCT01309659|144505069|SUPERIORITY_OR_OTHER|||||||0.396|TWO_SIDED|||||Correlation between iron and change in hemoglobin in the intermediate intervention group. Testing the correlation = 0.|t-test, 2 sided|||||||0.396
72488175|NCT01309659|144505069|SUPERIORITY_OR_OTHER|||||||0.106|TWO_SIDED|||||Correlation between iron and change in hemoglobin in the waitlist group. Testing the correlation = 0.|t-test, 2 sided|||||||0.106
72488176|NCT01309659|144505069|SUPERIORITY_OR_OTHER|||||||0.606|TWO_SIDED|||||Correlation between transferrin saturation and change in hemoglobin in the immediate intervention group. Testing the correlation = 0.|t-test, 2 sided|||||||0.606
72488177|NCT01309659|144505069|SUPERIORITY_OR_OTHER|||||||0.077|TWO_SIDED|||||Correlation between transferrin saturation and change in hemoglobin in the waitlist group. Testing the correlation = 0.|t-test, 2 sided|||||||0.077
72488178|NCT01309659|144505078|SUPERIORITY_OR_OTHER|||||||0.649|TWO_SIDED|||||Correlation between soluble transfer receptor and change in hemoglobin in the immediate intervention group. Testing the correlation =0.|t-test, 2 sided|||||||0.649
72488179|NCT01309659|144505078|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED|||||Correlation between soluble transfer receptor and change in hemoglobin in the wait list group. Testing the correlation =0.|t-test, 2 sided|||||||0.001
72488180|NCT01309659|144505079|SUPERIORITY_OR_OTHER|||||||0.391|TWO_SIDED|||||Correlation between baseline soluble transferrin receptor index (soluble receptor/log ferritin) and the change in hemoglobin in the immediate intervention group. Testing correlation =0.|t-test, 2 sided|||||||0.391
72488181|NCT01309659|144505079|SUPERIORITY_OR_OTHER|||||||0.111|TWO_SIDED|||||Correlation between baseline soluble transferrin receptor index (soluble receptor/log ferritin) and the change in hemoglobin in the wait list control group. Testing correlation =0.|t-test, 2 sided|||||||0.111
72488182|NCT01309659|144505080|SUPERIORITY_OR_OTHER|||||||0.077|TWO_SIDED|||||Correlation between baseline serum ferritin and the change in 6 Minute Walk Test distance in the immediate intervention group. Testing correlation =0.|t-test, 2 sided|||||||0.077
72488183|NCT01309659|144505080|SUPERIORITY_OR_OTHER|||||||0.798|TWO_SIDED|||||Correlation between baseline serum ferritin and the change in 6 Minute Walk Test distance in the wait list group. Testing correlation =0.|t-test, 2 sided|||||||0.798
72488184|NCT01309659|144505080|SUPERIORITY_OR_OTHER|||||||0.383|TWO_SIDED|||||Correlation between baseline iron and the change in 6 Minute Walk Test distance in the immediate intervention group. Testing correlation =0.|t-test, 2 sided|||||||0.383
72488185|NCT01309659|144505080|SUPERIORITY_OR_OTHER|||||||0.732|TWO_SIDED|||||Correlation between baseline iron and the change in 6 Minute Walk Test distance in the wait list group. Testing correlation =0.|t-test, 2 sided|||||||0.732
72488186|NCT01309659|144505080|SUPERIORITY_OR_OTHER|||||||0.286|TWO_SIDED|||||Correlation between baseline transferrin saturation and the change in 6 Minute Walk Test distance in the immediate intervention group. Testing correlation =0.|t-test, 2 sided|||||||0.286
72488187|NCT01309659|144505080|SUPERIORITY_OR_OTHER|||||||0.356|TWO_SIDED|||||Correlation between baseline transferrin saturation and the change in 6 Minute Walk Test distance in the wait list group. Testing correlation =0.|t-test, 2 sided|||||||0.356
72488188|NCT01309659|144505081|SUPERIORITY_OR_OTHER|||||||0.649|TWO_SIDED|||||Correlation between baseline soluble transferrin receptor and the change in the 6 Meter Walk Test distance of the immediate intervention group. Testing correlation =0.|t-test, 2 sided|||||||0.649
72488189|NCT01309659|144505081|SUPERIORITY_OR_OTHER|||||||0.396|TWO_SIDED|||||Correlation between baseline soluble transferrin receptor and the change in the 6 Meter Walk Test distance of the wait list group. Testing correlation =0.|t-test, 2 sided|||||||0.396
72488190|NCT01309659|144505082|SUPERIORITY_OR_OTHER|||||||0.624|TWO_SIDED|||||Correlation between baseline soluble transferrin receptor index (soluble receptor/log ferritin) and the change in the 6 Minute Walk Test Distance in the intermediate intervention group. Testing correlation =0.|t-test, 2 sided|||||||0.624
72488191|NCT01309659|144505082|SUPERIORITY_OR_OTHER|||||||0.329|TWO_SIDED|||||Correlation between baseline soluble transferrin receptor index (soluble receptor/log ferritin) and the change in the 6 Minute Walk Test Distance in the wait list group. Testing correlation =0.|t-test, 2 sided|||||||0.329
72515209|NCT02757092|144561142|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<0.05
72515210|NCT02757092|144561143|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<0.05
72515211|NCT02757092|144561144|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<0.05
72403618|NCT02404350|144313098|SUPERIORITY||Treatment contrast in LS mean (Change)|-0.66|STANDARD_ERROR_OF_MEAN|0.096|<|0.0001|TWO_SIDED|95.0|-0.85|-0.47|||Mixed Models Analysis|LS Mean, 95% CI, and p-value are from a mixed model repeated measures (MMRM)||Mixed model with treatment regimen, analysis visit and randomization stratum (TNF-alpha status -naïve or IR) as factors, weight and baseline score as continuous covariates, and treatment by analysis visit and baseline score by analysis visit as interaction terms, using an unstructured covariance structure||-0.47|-0.85|<0.0001
72403619|NCT02404350|144313098|SUPERIORITY||Treatment Contrast in LS Mean (Change)|-0.66|STANDARD_ERROR_OF_MEAN|0.096|<|0.0001|TWO_SIDED|95.0|-0.85|-0.47|||Mixed Models Analysis|LS Mean, 95% CI, and p-value are from a mixed model repeated measures (MMRM)||Mixed model with treatment regimen, analysis visit and randomization stratum (TNF-alpha status -naïve or IR) as factors, weight and baseline score as continuous covariates, and treatment by analysis visit and baseline score by analysis visit as interaction terms, using an unstructured covariance structure||-0.47|-0.85|<0.0001
72403620|NCT02404350|144313098|SUPERIORITY||Treatment contrast in LS mean (Change)|-0.86|STANDARD_ERROR_OF_MEAN|0.096|<|0.0001|TWO_SIDED|95.0|-1.05|-0.67|||Mixed Models Analysis|LS Mean, 95% CI, and p-value are from a mixed model repeated measures (MMRM)||Mixed model with treatment regimen, analysis visit and randomization stratum (TNF-alpha status -naïve or IR) as factors, weight and baseline score as continuous covariates, and treatment by analysis visit and baseline score by analysis visit as interaction terms, using an unstructured covariance structure||-0.67|-1.05|<0.0001
72403621|NCT02404350|144313099|SUPERIORITY||Odds Ratio (OR)|0.75||||0.225|TWO_SIDED|95.0|0.47|1.19|||Regression, Logistic|||||1.19|0.47|0.2250
72488192|NCT02285777|144505089|OTHER|Pre-specified.|Vaccine Effectiveness|71.0||||0.0001|TWO_SIDED|95.0|69.0|73.0|||Generalized Linear Model|To obtain the VE measure which is a measure based on RR, BINOMIAL DISTRIBUTION \& LOG LINK options were used to compute log10 RR \& corresponding CI.||The Vaccine Effectiveness (VE) at 1 month after the 3-dose vaccination series for each strain is defined as \[1 - (percentage of subjects without bactericidal activity at 1:4 dilution in MenABCWY group/percentage of subjects without bactericidal activity at 1:4 dilution in MenACWY group)\] x 100.The combined VE across all strains was computed by mean of a generalized linear model.||73|69|0.0001
72403622|NCT02404350|144313099|SUPERIORITY||Odds Ratio (OR)|0.45||||0.0004|TWO_SIDED|95.0|0.29|0.7|||Regression, Logistic|||||0.70|0.29|0.0004
72515212|NCT02757092|144561145|SUPERIORITY||||||<|0.05|||||||ANOVA|||null hypothesis||||<0.05
72515213|NCT02757092|144561146|SUPERIORITY||||||<|0.05|||||||ANOVA|||null hypothesis||||<0.05
72515214|NCT02757092|144561147|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<0.05
72515215|NCT02757092|144561148|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<0.05
72515216|NCT02757092|144561149|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<0.05
72515217|NCT02757092|144561150|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<0.05
72515218|NCT02757092|144561151|SUPERIORITY|||||||0.05|||||||Chi-squared|||Descriptive statistics were expressed as mean ± standard deviation or median and interquartile range depending on the nature and distribution of the variables||||0.05
72624280|NCT00863304|144778627|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.88|STANDARD_ERROR_OF_MEAN|0.24|<|0.001|TWO_SIDED|95.0|-1.34|-0.41||P-value was based on pairwise comparisons.|ANCOVA|||Week 8: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.41|-1.34|<0.001
72403623|NCT02404350|144313099|SUPERIORITY||Odds Ratio, log|0.44||||0.0004|TWO_SIDED|95.0|0.28|0.69|||Regression, Logistic|||||0.69|0.28|0.0004
72403624|NCT02404350|144313100|SUPERIORITY||Odds Ratio (OR)|0.37||||0.0004|TWO_SIDED|95.0|0.22|0.65|||Regression, Logistic|||||0.65|0.22|0.0004
72403625|NCT02404350|144313100|SUPERIORITY||Odds Ratio (OR)|0.34||||0.0003|TWO_SIDED|95.0|0.19|0.6|||Regression, Logistic|||||0.60|0.19|0.0003
72403626|NCT02404350|144313100|SUPERIORITY||Odds Ratio (OR)|0.24|||<|0.0001|TWO_SIDED|95.0|0.13|0.44|||Regression, Logistic|||||0.44|0.13|<0.0001
72403627|NCT04007523|144313134|OTHER|Fisher's Exact Test||||||0.653|||||||Fisher Exact|||||||0.653
72403628|NCT04007523|144313134|OTHER|Fisher's Exact Test||||||0.614|||||||Fisher Exact|||||||0.614
72515219|NCT02757092|144561152|SUPERIORITY||||||<|0.05|||||||ANOVA|||null hypothesis||||<0.05
72515220|NCT02757092|144561153|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<0.05
72515221|NCT02757092|144561154|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<0.05
72515222|NCT02757092|144561155|SUPERIORITY||||||<|0.05|||||||ANOVA|||null hypothesis||||<0.05
72515223|NCT02757092|144561157|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<0.05
72515224|NCT02757092|144561158|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<0.05
72515225|NCT02757092|144561159|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<0.05
72515226|NCT02757092|144561160|SUPERIORITY||||||<|0.05|||||||Chi-squared|||null hypothesis||||<0.05
72515227|NCT02757092|144561161|SUPERIORITY||||||<|0.05|||||||ANOVA|||null hypothesis||||<0.05
72515228|NCT02757092|144561162|SUPERIORITY||||||<|0.05|||||||ANOVA|||null hypothesis||||<0.05
72515229|NCT02757092|144561163|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<0.05
72515230|NCT02757092|144561164|SUPERIORITY||||||<|0.05|||||||ANOVA|||null hypothesis||||<0.05
72515231|NCT02757092|144561166|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<0.05
72515232|NCT02757092|144561167|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<0.05
72515233|NCT02757092|144561168|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<0.05
72515234|NCT01646398|144561172|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|1.3|||||TWO_SIDED|95.0|0.99|1.75||||||Serotype 1: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS).||1.75|0.99|
72515235|NCT01646398|144561172|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|0.7|||||TWO_SIDED|95.0|0.59|0.89||||||Serotype 3: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS).||0.89|0.59|
72515236|NCT01646398|144561172|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|2.6|||||TWO_SIDED|95.0|1.96|3.44||||||Serotype 4: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS).||3.44|1.96|
72488193|NCT02285777|144505090|OTHER|Pre-specified.|Vaccine Effectiveness|51.0||||0.0001|TWO_SIDED|95.0|48.0|55.0|||Generalized Linear Model|To obtain the VE measure which is a measure based on RR, BINOMIAL DISTRIBUTION \& LOG LINK options were used to compute log10 RR \& corresponding CI.||The Vaccine Effectiveness (VE) at 4 months after the 3-dose vaccination series for each strain is defined as \[1 - (percentage of subjects without bactericidal activity at 1:4 dilution in MenABCWY group/percentage of subjects without bactericidal activity at 1:4 dilution in MenACWY group)\] x 100. The combined VE across all strains was computed by mean of a generalized linear model.||55|48|0.0001
72488194|NCT02285777|144505091|OTHER|Pre-specified.|Vaccine Effectiveness|51.0||||0.0001|TWO_SIDED|95.0|48.0|54.0|||Generalized Linear Model|To obtain the VE measure which is a measure based on RR, BINOMIAL DISTRIBUTION \& LOG LINK options were used to compute log10 RR \& corresponding CI.||The Vaccine Effectiveness (VE) at 1 month after the 3-dose vaccination series for each strain is defined as \[1 - (percentage of subjects without bactericidal activity at 1:8 dilution in MenABCWY group/percentage of subjects without bactericidal activity at 1:8 dilution in MenACWY group)\] x 100. The combined VE across all strains was computed by mean of a generalized linear model.||54|48|0.0001
72488195|NCT02285777|144505091|OTHER|Pre-specified.|Vaccine Effectiveness|24.0||||0.0001||95.0|20.0|28.0|||Generalized Linear Model|To obtain the VE measure which is a measure based on RR, BINOMIAL DISTRIBUTION \& LOG LINK options were used to compute log10 RR \& corresponding CI.||The Vaccine Effectiveness (VE) at 4 months after the 3-dose vaccination series for each strain is defined as \[1 - (percentage of subjects without bactericidal activity at 1:8 dilution in MenABCWY group/percentage of subjects without bactericidal activity at 1:8 dilution in MenACWY group)\] x 100. The combined VE across all strains was computed by mean of a generalized linear model.||28|20|0.0001
72488196|NCT00271596|144505121|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.166|STANDARD_ERROR_OF_MEAN|0.098||0.092|TWO_SIDED|95.0|-0.361|0.028|||2-tailed linear treatment contrast|This was a predefined 2-tailed linear treatment contrast of intention-to-treat, with Kenward-Rogers correction (t statistic).||Mixed linear model with treatment-group-specific random subject effects: Predefined 2-tailed linear treatment contrast of intention-to-treat, with Kenward-Rogers correction (t statistic).||0.028|-0.361|0.092
72488197|NCT00271596|144505122|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.337|STANDARD_ERROR_OF_MEAN|0.168||0.048|TWO_SIDED|95.0|-0.672|-0.003|||2-tailed linear treatment contrast|This was a predefined 2-tailed linear treatment contrast of intention-to-treat, with Kenward-Rogers correction (t statistic).||Mixed linear model with treatment-group-specific random subject effects: Predefined 2-tailed linear treatment contrast of intention-to-treat, with Kenward-Rogers correction (t statistic).||-0.003|-0.672|0.048
72488198|NCT00271596|144505123|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.278|STANDARD_ERROR_OF_MEAN|0.268||0.302|TWO_SIDED|95.0|-0.81|0.254|||2-tailed linear treatment contrast|This was a predefined 2-tailed linear treatment contrast of intention-to-treat, with Kenward-Rogers correction (t statistic)||Mixed linear model with treatment-group-specific random subject effects: Predefined 2-tailed linear treatment contrast of intention-to-treat, with Kenward-Rogers correction (t statistic).||0.254|-0.810|0.302
72488199|NCT00271596|144505124|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.057|STANDARD_ERROR_OF_MEAN|0.153||0.708|TWO_SIDED|95.0|-0.361|0.246|||2-tailed linear treatment contrast|This was a predefined 2-tailed linear treatment contrast of intention-to-treat, with Kenward-Rogers correction (t statistic).||Mixed linear model with treatment-group-specific random subject effects: Predefined 2-tailed linear treatment contrast of intention-to-treat, with Kenward-Rogers correction (t statistic).||0.246|-0.361|0.708
72488200|NCT00271596|144505125|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.069|STANDARD_ERROR_OF_MEAN|0.15||0.646|TWO_SIDED|95.0|-0.229|0.367|||2-tailed linear treatment contrast|This was a predefined 2-tailed linear treatment contrast of intention-to-treat, with Kenward-Rogers correction (t statistic).||Mixed linear model with treatment-group-specific random subject effects: Predefined 2-tailed linear treatment contrast of intention-to-treat, with Kenward-Rogers correction (t statistic).||0.367|-0.229|0.646
72515237|NCT01646398|144561172|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|2.9|||||TWO_SIDED|95.0|2.22|3.86||||||Serotype 5: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS).||3.86|2.22|
72515238|NCT01646398|144561172|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|1.4|||||TWO_SIDED|95.0|1.1|1.75||||||Serotype 6B: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS).||1.75|1.10|
72515239|NCT01646398|144561172|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|1.4|||||TWO_SIDED|95.0|1.12|1.74||||||Serotype 7F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS).||1.74|1.12|
72515240|NCT01646398|144561172|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|2.3|||||TWO_SIDED|95.0|1.59|3.24||||||Serotype 9V: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS).||3.24|1.59|
72403629|NCT04007523|144313134|OTHER|Fisher's Exact Test||||||0.999|||||||Fisher Exact|||||||0.999
72488201|NCT00271596|144505126|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.21|STANDARD_ERROR_OF_MEAN|0.174||0.23||95.0|-0.554|0.135|||2-tailed linear treatment contrast|This was a predefined 2-tailed linear treatment contrast of intention-to-treat, with Kenward-Rogers correction (t statistic).||Mixed linear model with treatment-group-specific random subject effects: Predefined 2-tailed linear treatment contrast of intention-to-treat, with Kenward-Rogers correction (t statistic).||0.135|-0.554|0.230
72515241|NCT01646398|144561172|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|1.0|||||TWO_SIDED|95.0|0.77|1.23||||||Serotype 14: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS).||1.23|0.77|
72488202|NCT00271596|144505127|SUPERIORITY_OR_OTHER||Median Difference (Net)|-0.317|STANDARD_ERROR_OF_MEAN|0.482||0.512|TWO_SIDED|95.0|-1.276|0.642|||2-tailed linear treatment contrast|This was a predefined 2-tailed linear treatment contrast of intention-to-treat, with Kenward-Rogers correction (t statistic).||Mixed linear model with treatment-group-specific random subject effects: Predefined 2-tailed linear treatment contrast of intention-to-treat, with Kenward-Rogers correction (t statistic).||0.642|-1.276|0.512
72488203|NCT00271596|144505128|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.9|STANDARD_ERROR_OF_MEAN|1.17||0.12|TWO_SIDED|95.0|-4.3|0.5|||2-tailed linear treatment contrast|This was a predefined 2-tailed linear treatment contrast of intention-to-treat, with Kenward-Rogers correction (t statistic).||Mixed linear model with treatment-group-specific random subject effects: Predefined 2-tailed linear treatment contrast of intention-to-treat, with Kenward-Rogers correction (t statistic).||0.50|-4.30|0.12
72488204|NCT00271596|144505129|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.48|STANDARD_ERROR_OF_MEAN|0.68||0.49|TWO_SIDED|95.0|-1.87|0.91|||2-tailed linear treatment contrast|This was a predefined 2-tailed linear treatment contrast of intention-to-treat, with Kenward-Rogers correction (t statistic).||Mixed linear model with treatment-group-specific random subject effects: Predefined 2-tailed linear treatment contrast of intention-to-treat, with Kenward-Rogers correction (t statistic).||0.91|-1.87|0.49
72403630|NCT04652479|144313160|OTHER|||||||0.0028||||||A p-value of \<0.05 would be considered statistically significant|Mixed effects model|||Within-group analysis||||0.0028
72403631|NCT04652479|144313160|OTHER|||||||0.0005||||||A p-value of \<0.05 would be considered statistically significant|Mixed effects model|||Within-group analysis||||0.0005
72403632|NCT04652479|144313161|OTHER|||||||0.0027||||||A p-value of \<0.05 would be considered statistically significant|Mixed effects model|||Within-group analysis||||0.0027
72488205|NCT00271596|144505130|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|-2.5|STANDARD_ERROR_OF_MEAN|1.23||0.05|TWO_SIDED|95.0|-5.04|0.04||Predefined 2-tailed linear treatment contrast of intention-to-treat, with Kenward-Rogers correction (t statistic).|Mixed Models Analysis|||Mixed linear model with treatment-group-specific random subject effects: Predefined 2-tailed linear treatment contrast of intention-to-treat, with Kenward-Rogers correction (t statistic).||0.04|-5.04|0.05
72488206|NCT01431274|144505139|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.123|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|0.1|0.146||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within-patient errors."|||0.146|0.100|<0.0001
72488207|NCT01431274|144505139|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.117|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001||95.0|0.094|0.14||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Tiotropium (5 μg).~Spatial power covariance structure for within-patient errors."|||0.140|0.094|<0.0001
72488208|NCT01431274|144505139|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.109|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|0.086|0.132||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within-patient errors."|||0.132|0.086|<0.0001
72488209|NCT01431274|144505139|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.093|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|0.07|0.116||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.116|0.070|<0.0001
72488210|NCT01431274|144505139|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.102|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|0.08|0.125||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (5 µg).~Spatial power covariance structure for within-patient errors."|||0.125|0.080|<0.0001
72515242|NCT01646398|144561172|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|2.1|||||TWO_SIDED|95.0|1.61|2.86||||||Serotype 18C: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS).||2.86|1.61|
72403633|NCT04652479|144313161|OTHER|||||||0.0043||||||A p-value of \<0.05 would be considered statistically significant|Mixed effects model|||Within-group analysis||||0.0043
72515243|NCT01646398|144561172|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|2.3|||||TWO_SIDED|95.0|1.81|2.92||||||Serotype 19A: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS).||2.92|1.81|
72403634|NCT04652479|144313162|OTHER|||||||0.0003||||||A p-value of \<0.05 would be considered statistically significant|Mixed effects model|||Within-group analysis||||0.0003
72403635|NCT04652479|144313162|OTHER|||||||0.0003||||||A p-value of \<0.05 would be considered statistically significant|Mixed effects model|||Within-group analysis||||0.0003
72403636|NCT04652479|144313163|OTHER|||||||0.161||||||A p-value of \<0.05 would be considered statistically significant|t-test, 2 sided|||Between-group analysis of change from baseline||||0.161
72403637|NCT04652479|144313163|OTHER||Mean Difference (Net)|-35.66||||0.201|TWO_SIDED|||||A p-value of \<0.05 would be considered statistically significant|t-test, 2 sided|||Within-group analysis of change from baseline||||0.201
72403638|NCT04652479|144313163|OTHER||Mean Difference (Net)|-67.65||||0.001|TWO_SIDED|||||A p-value of \<0.05 would be considered statistically significant|t-test, 2 sided|||Within-group analysis of change from baseline||||0.001
72403639|NCT04652479|144313164|OTHER|||||||0.145||||||A p-value of \<0.05 would be considered statistically significant|t-test, 2 sided|||Between-group analysis of change from baseline||||0.145
72488211|NCT01431274|144505139|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.014|STANDARD_ERROR_OF_MEAN|0.012||0.2169|TWO_SIDED|95.0|-0.008|0.037||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tio+Olo FDC (2.5/5 µg).~Spatial power covariance structure for within-patient errors."|||0.037|-0.008|0.2169
72488212|NCT01431274|144505139|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.108|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|0.085|0.13||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.130|0.085|<0.0001
72488213|NCT01431274|144505139|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.006|STANDARD_ERROR_OF_MEAN|0.012||0.5849|TWO_SIDED|95.0|-0.017|0.029||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within-patient errors."|||0.029|-0.017|0.5849
72488214|NCT01431274|144505139|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.016|STANDARD_ERROR_OF_MEAN|0.012||0.1863|TWO_SIDED|95.0|-0.007|0.039||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (2.5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within-patient errors."|||0.039|-0.007|0.1863
72488215|NCT01431274|144505139|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.009|STANDARD_ERROR_OF_MEAN|0.012||0.4352|TWO_SIDED|95.0|-0.032|0.014||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.014|-0.032|0.4352
72488216|NCT01431274|144505140|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.082|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|0.059|0.106||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within-patient errors."|||0.106|0.059|<.0001
72488217|NCT01431274|144505140|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.071|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|0.047|0.094||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Tiotropium (5 μg).~Spatial power covariance structure for within-patient errors."|||0.094|0.047|<0.0001
72515244|NCT01646398|144561172|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|2.0|||||TWO_SIDED|95.0|1.42|2.79||||||Serotype 19F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS).||2.79|1.42|
72515245|NCT01646398|144561172|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|2.5|||||TWO_SIDED|95.0|1.84|3.49||||||Serotype 23F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS).||3.49|1.84|
72515246|NCT01646398|144561173|SUPERIORITY_OR_OTHER||Difference in percentage|26.8|||||TWO_SIDED|95.0|19.3|34.0||||||Difference in proportions (13vPnC - 23vPS) expressed as a percentage presented along with exact, 2-sided 95%CI. Statistical significance was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.||34.0|19.3|
72515247|NCT01646398|144561174|SUPERIORITY_OR_OTHER||GMT Ratio|1.3|||||TWO_SIDED|95.0|0.99|1.75||||||Serotype 1: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS). Statistical significance was to be concluded if the lower bound of the 2-sided 95% CI was greater than 1.0.||1.75|0.99|
72403640|NCT04652479|144313164|OTHER||Mean Difference (Net)|-31.88||||0.111|TWO_SIDED|||||A p-value of \<0.05 would be considered statistically significant|t-test, 2 sided||Change in percentage|Within-group analysis of change from baseline||||0.111
72403641|NCT04652479|144313164|OTHER||Mean Difference (Net)|-53.37||||0.001|TWO_SIDED|||||A p-value of \<0.05 would be considered statistically significant|t-test, 2 sided||Change in percentage|Within-group analysis of change from baseline||||0.001
72488218|NCT01431274|144505140|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.058|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|0.034|0.081||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within-patient errors."|||0.081|0.034|<0.0001
72515248|NCT01646398|144561174|SUPERIORITY_OR_OTHER||GMT Ratio|0.7|||||TWO_SIDED|95.0|0.59|0.89||||||Serotype 3: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS). Statistical significance was to be concluded if the lower bound of the 2-sided 95% CI was greater than 1.0.||0.89|0.59|
72515249|NCT01646398|144561174|SUPERIORITY_OR_OTHER||GMT Ratio|2.6|||||TWO_SIDED|95.0|1.96|3.44||||||Serotype 4: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS). Statistical significance was to be concluded if the lower bound of the 2-sided 95% CI was greater than 1.0.||3.44|1.96|
72515250|NCT01646398|144561174|SUPERIORITY_OR_OTHER||GMT Ratio|2.9|||||TWO_SIDED|95.0|2.22|3.86||||||Serotype 5: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS). Statistical significance was to be concluded if the lower bound of the 2-sided 95% CI was greater than 1.0.||3.86|2.22|
72515251|NCT01646398|144561174|SUPERIORITY_OR_OTHER||GMT Ratio|1.4|||||TWO_SIDED|95.0|1.1|1.75||||||Serotype 6B: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS). Statistical significance was to be concluded if the lower bound of the 2-sided 95% CI was greater than 1.0.||1.75|1.10|
72515252|NCT01646398|144561174|SUPERIORITY_OR_OTHER||GMT Ratio|1.4|||||TWO_SIDED|95.0|1.12|1.74||||||Serotype 7F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS). Statistical significance was to be concluded if the lower bound of the 2-sided 95% CI was greater than 1.0.||1.74|1.12|
72515253|NCT01646398|144561174|SUPERIORITY_OR_OTHER||GMT Ratio|2.3|||||TWO_SIDED|95.0|1.59|3.24||||||Serotype 9V: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS). Statistical significance was to be concluded if the lower bound of the 2-sided 95% CI was greater than 1.0.||3.24|1.59|
72515254|NCT01646398|144561174|SUPERIORITY_OR_OTHER||GMT Ratio|1.0|||||TWO_SIDED|95.0|0.77|1.23||||||Serotype 14: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS). Statistical significance was to be concluded if the lower bound of the 2-sided 95% CI was greater than 1.0.||1.23|0.77|
72515255|NCT01646398|144561174|SUPERIORITY_OR_OTHER||GMT Ratio|2.1|||||TWO_SIDED|95.0|1.61|2.86||||||Serotype 18C: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS). Statistical significance was to be concluded if the lower bound of the 2-sided 95% CI was greater than 1.0.||2.86|1.61|
72515256|NCT01646398|144561174|SUPERIORITY_OR_OTHER||GMT Ratio|2.3|||||TWO_SIDED|95.0|1.81|2.92||||||Serotype 19A: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS). Statistical significance was to be concluded if the lower bound of the 2-sided 95% CI was greater than 1.0.||2.92|1.81|
72515257|NCT01646398|144561174|SUPERIORITY_OR_OTHER||GMT Ratio|2.0|||||TWO_SIDED|95.0|1.42|2.79||||||Serotype 19F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS). Statistical significance was to be concluded if the lower bound of the 2-sided 95% CI was greater than 1.0.||2.79|1.42|
72515258|NCT01646398|144561174|SUPERIORITY_OR_OTHER||GMT Ratio|2.5|||||TWO_SIDED|95.0|1.84|3.49||||||Serotype 23F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS). Statistical significance was to be concluded if the lower bound of the 2-sided 95% CI was greater than 1.0.||3.49|1.84|
72515259|NCT01646398|144561174|SUPERIORITY_OR_OTHER||GMT Ratio|3.1|||||TWO_SIDED|95.0|2.38|4.14||||||Serotype 6A: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS). Statistical significance was to be concluded if the lower bound of the 2-sided 95% CI was greater than 2.0.||4.14|2.38|
72515260|NCT02667457|144561191|OTHER|||||||0.0095||||||p-value is based on t-test with unequal variances (Satterthwaite) if p-value of F-test for Equality of variances is significant (p\<0.05) otherwise p-value is based on t-test with equal variances.|t-test, 1 sided|||Timepoint = 60 minutes||||0.0095
72515261|NCT02667457|144561191|OTHER|||||||0.0029||||||p-value is based on t-test with unequal variances (Satterthwaite) if p-value of F-test for Equality of variances is significant (p\<0.05) otherwise p-value is based on t-test with equal variances.|t-test, 1 sided|||Timepoint = 120 minutes||||0.0029
72515262|NCT02667457|144561192|OTHER|||||||0.0066||||||p-value is based on t-test with unequal variances (Satterthwaite) if p-value of F-test for Equality of variances is significant (p\<0.05) otherwise p-value is based on t-test with equal variances.|t-test, 1 sided|||Timepoint = 60 minutes||||0.0066
72515263|NCT02667457|144561192|OTHER|||||||0.0334||||||p-value is based on t-test with unequal variances (Satterthwaite) if p-value of F-test for Equality of variances is significant (p\<0.05) otherwise p-value is based on t-test with equal variances.|t-test, 1 sided|||Timepoint = 120 minutes||||0.0334
72515264|NCT02667457|144561193|OTHER|||||||0.0066||||||p-value is based on t-test with unequal variances (Satterthwaite) if p-value of F-test for Equality of variances is significant (p\<0.05) otherwise p-value is based on t-test with equal variances.|t-test, 1 sided|||Timepoint = 60 minutes||||0.0066
72515265|NCT02667457|144561193|OTHER|||||||0.0301||||||p-value is based on t-test with unequal variances (Satterthwaite) if p-value of F-test for Equality of variances is significant (p\<0.05) otherwise p-value is based on t-test with equal variances.|t-test, 1 sided|||Timepoint = 120 minutes||||0.0301
72515266|NCT02667457|144561194|OTHER|||||||0.0066||||||p-value is based on t-test with unequal variances (Satterthwaite) if p-value of F-test for Equality of variances is significant (p\<0.05) otherwise p-value is based on t-test with equal variances.|t-test, 1 sided|||Timepoint = 60 minutes||||0.0066
72515267|NCT02667457|144561194|OTHER|||||||0.0387||||||p-value is based on t-test with unequal variances (Satterthwaite) if p-value of F-test for Equality of variances is significant (p\<0.05) otherwise p-value is based on t-test with equal variances.|t-test, 1 sided|||Timepoint = 120 minutes||||0.0387
72515268|NCT02667457|144561195|OTHER|||||||0.0359||||||p-value is based on t-test with unequal variances (Satterthwaite) if p-value of F-test for Equality of variances is significant (p\<0.05) otherwise p-value is based on t-test with equal variances.|t-test, 1 sided|||Timepoint = 60 minutes||||0.0359
72515269|NCT02667457|144561195|OTHER|||||||0.0022||||||p-value is based on t-test with unequal variances (Satterthwaite) if p-value of F-test for Equality of variances is significant (p\<0.05) otherwise p-value is based on t-test with equal variances.|t-test, 1 sided|||Timepoint = 120 minutes||||0.0022
72403642|NCT05544786|144313168|OTHER|The analysis used a mixed effect model with sequence, period and treatment as fixed effects and participant within a sequence as a random effect for comparison: powder mixed with water (fasted) group versus tablets group.|Ratio (%) of Adjusted Geometric Mean|113.13|||||TWO_SIDED|90.0|102.77|124.53|||||The ratios (and 90% confidence Intervals \[CIs\]) are expressed as percentages.|Reference: Nirmatrelvir/ritonavir 300/100 mg tablets (fasted) Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with water (fasted)||124.53|102.77|
72403643|NCT05544786|144313168|OTHER|The analysis used a mixed effect model with sequence, period and treatment as fixed effects and participant within a sequence as a random effect for comparison: powder mixed with infant formula (fasted) group versus tablets group.|Ratio (%) of Adjusted Geometric Mean|121.91|||||TWO_SIDED|90.0|110.75|134.2|||||The ratios (and 90% CIs) are expressed as percentages.|Reference: Nirmatrelvir/ritonavir 300/100 mg tablets (fasted) Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with infant formula (fasted)||134.20|110.75|
72568227|NCT00899470|144668034|NON_INFERIORITY_OR_EQUIVALENCE|If no difference between bioavailabilities of saxagliptin from FDC tablet vs. co-administration of saxagliptin tablet and metformin (fed condition), then 20 subjects provided 99% power to conclude BE with respect to AUC(INF) of saxagliptin. If 5% difference then 20 subjects provided 99% power to conclude BE with respect to AUC(INF) of saxagliptin.|Geometric Means Ratio Test vs. Reference|1.022|||||TWO_SIDED|95.0|0.985|1.06|||Mixed Models Analysis|Bioequivalence=90% CIs for the test|For AUC(INF) of saxagliptin, the point estimate and 90% CI were calculated for the ratio of the geometric mean of the Test formulation in fed state: the geometric mean of the Reference formulation in fed state|To demonstrate BE of FDC tablets (Test) versus co-administration of saxagliptin and metformin IR tablets (Reference) formulations in fed state, linear mixed model analysis was performed on log\[AUC(INF)\] of saxagliptin and metformin. Factors in the model were sequence, period and treatment as fixed effects, and participant within sequence as a random effect.||1.060|0.985|
72403644|NCT05544786|144313168|OTHER|The analysis used a mixed effect model with treatment as a fixed effect and participant as a random effect for comparison: powder mixed with vanilla pudding (fasted) group versus tablets group.|Ratio (%) of Adjusted Geometric Mean|125.49|||||TWO_SIDED|90.0|114.43|137.61|||||The ratios (and 90% CIs) are expressed as percentages.|Reference: Nirmatrelvir/ritonavir 300/100 mg tablets (fasted) Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with vanilla pudding (fasted)||137.61|114.43|
72403645|NCT05544786|144313168|OTHER|The analysis used a mixed effect model with treatment as a fixed effect and participant as a random effect for comparison: powder mixed with vanilla pudding (fed) group versus tablets group.|Ratio (%) of Adjusted Geometric Mean|121.09|||||TWO_SIDED|90.0|110.42|132.79|||||The ratios (and 90% CIs) are expressed as percentages.|Reference: Nirmatrelvir/ritonavir 300/100 mg tablets (fasted) Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with vanilla pudding (fed)||132.79|110.42|
72568228|NCT00899470|144668036|NON_INFERIORITY_OR_EQUIVALENCE|If no difference between bioavailabilities of metformin from FDC tablet vs. co-administration of saxagliptin tablet and metformin (fasted and fed), then 20 subjects provided 98% power to conclude BE with respect to Cmax of metformin. If 5% difference then 20 subjects provided 93% power to conclude BE with respect to Cmax of metformin, respectively.|Geometric Mean Ratio, Test vs. Reference|1.009|||||TWO_SIDED|90.0|0.939|1.084|||Mixed Models Analysis|Bioequivalence=90% CIs for the test|For Cmax of metformin, the point estimate and 90% CI were calculated for the ratio of the geometric mean of the Test formulation in fasted state: geometric mean of the Reference formulation in fasted fed state|To demonstrate BE of FDC tablets (Test) versus co-administration of saxagliptin and metformin IR tablets (Reference) formulations in fasted state, linear mixed model analysis was performed on log(Cmax) of metformin. Factors in the model were sequence, period and treatment as fixed effects, and participant within sequence as a random effect.||1.084|0.939|
72568229|NCT00899470|144668036|NON_INFERIORITY_OR_EQUIVALENCE|If no difference between bioavailabilities of metformin from FDC tablet vs. co-administration of saxagliptin tablet and metformin (fed), then 20 subjects provided 98% power to conclude BE with respect to Cmax of metformin. If 5% difference then 20 subjects provided 93% power to conclude BE with respect to Cmax of metformin.|Geometric Mean Ratio, Test vs. Reference|1.034|||||TWO_SIDED|90.0|0.962|1.111|||Mixed Models Analysis|Bioequivalence=90% CIs for the test|For Cmax of metformin, the point estimate and 90% CI were calculated for the ratio of the geometric mean of the Test formulation in fed state: the geometric mean of the Reference formulation in fed state|To demonstrate BE of FDC tablets (Test) versus co-administration of saxagliptin and metformin IR tablets (Reference) formulations in fed state, linear mixed model analysis was performed on log(Cmax) of metformin. Factors in the model were sequence, period and treatment as fixed effects, and participant within sequence as a random effect.||1.111|0.962|
72568230|NCT00899470|144668037|NON_INFERIORITY_OR_EQUIVALENCE|If no difference between bioavailabilities of metformin from FDC tablet vs. co-administration of saxagliptin tablet and metformin (fasted), then 20 subjects provided 99% power to conclude BE with respect to AUC(INF) of metformin. If 5% difference then 20 subjects provided 95% power to conclude BE with respect to AUC(INF) of metformin.|Geometric Mean Ratio, Test vs. Reference|1.024|||||TWO_SIDED|90.0|0.964|1.088|||Mixed Models Analysis|Bioequivalence=90% CIs for the test|For AUC(0-T) of metformin the point estimate and 90% CI were calculated for the ratio of the geometric mean of the Test formulation in fasted state: geometric mean of the Reference formulation in fasted state|To demonstrate BE of FDC tablets (Test) versus co-administration of saxagliptin and metformin IR tablets (Reference) formulations in fasted state, linear mixed model analysis was performed on log\[AUC(0-T)\] of metformin. Factors in the model were sequence, period and treatment as fixed effects, and participant within sequence as a random effect.||1.088|0.964|
72577108|NCT00580788|144680821|NON_INFERIORITY_OR_EQUIVALENCE|The study was designed as a standard dose-escalation study, dose-finding pilot study. The primary outcome measures were safety (hypercalcemia, hypophosphatemia and symptoms/hemodynamic measurements). A modified Fibronacci dose-escalation scheme was employed.|||||<|0.05|TWO_SIDED|||||the reported p-values correspond to the decrease compared to baseline in all arms/groups at Days 2-8|Mixed Models Analysis|The level of statistical significance was set at .05 (two-tailed)||||||<0.05
72488219|NCT01431274|144505140|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.029|STANDARD_ERROR_OF_MEAN|0.012||0.0174|TWO_SIDED|95.0|0.005|0.052||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.052|0.005|0.0174
72515270|NCT02475850|144561200|SUPERIORITY||Hazard Ratio (HR)|0.92||||0.245|TWO_SIDED|95.0|0.8|1.06||p\<0.05 threshold (primary outcome)|Regression, Cox|multistate model accounting for death as a semi-competing risk||||1.06|0.80|0.245
72403646|NCT05544786|144313169|OTHER|The analysis used a mixed effect model with sequence, period and treatment as fixed effects and participant within a sequence as a random effect for comparison: powder mixed with water (fasted) group versus tablets group.|Ratio (%) of Adjusted Geometric Mean|113.62|||||TWO_SIDED|90.0|102.96|125.4|||||The ratios (and 90% CIs) are expressed as percentages.|Reference: Nirmatrelvir/ritonavir 300/100 mg tablets (fasted) Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with water (fasted)||125.40|102.96|
72403647|NCT05544786|144313169|OTHER|The analysis used a mixed effect model with sequence, period and treatment as fixed effects and participant within a sequence as a random effect for comparison: powder mixed with infant formula (fasted) group versus tablets group.|Ratio (%) of Adjusted Geometric Mean|122.53|||||TWO_SIDED|90.0|111.02|135.22|||||The ratios (and 90% CIs) are expressed as percentages.|Reference: Nirmatrelvir/ritonavir 300/100 mg tablets (fasted) Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with infant formula (fasted)||135.22|111.02|
72403648|NCT05544786|144313169|OTHER|The analysis used a mixed effect model with treatment as a fixed effect and participant as a random effect for comparison: powder mixed with vanilla pudding (fasted) group versus tablets group.|Ratio (%) of Adjusted Geometric Mean|126.55|||||TWO_SIDED|90.0|115.0|139.27|||||The ratios (and 90% CIs) are expressed as percentages.|Reference: Nirmatrelvir/ritonavir 300/100 mg tablets (fasted) Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with vanilla pudding (fasted)||139.27|115.00|
72403649|NCT05544786|144313169|OTHER|The analysis used a mixed effect model with treatment as a fixed effect and participant as a random effect for comparison: powder mixed with vanilla pudding (fed) group versus tablets group.|Ratio (%) of Adjusted Geometric Mean|122.28|||||TWO_SIDED|90.0|111.11|134.57|||||The ratios (and 90% CIs) are expressed as percentages.|Reference: Nirmatrelvir/ritonavir 300/100 mg tablets (fasted) Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with vanilla pudding (fed)||134.57|111.11|
72515271|NCT02475850|144561201|SUPERIORITY||Hazard Ratio (HR)|0.9||||0.004|TWO_SIDED|99.0|0.83|0.99||p\< 0.01 threshold (secondary outcome)|Regression, Cox|||||0.99|0.83|0.004
72403650|NCT05544786|144313170|OTHER|The analysis used a mixed effect model with sequence, period and treatment as fixed effects and participant within a sequence as a random effect for comparison: powder mixed with water (fasted) group versus tablets group.|Ratio (%) of Adjusted Geometric Mean|110.28|||||TWO_SIDED|90.0|99.01|122.82|||||The ratios (and 90% CIs) are expressed as percentages.|Reference: Nirmatrelvir/ritonavir 300/100 mg tablets (fasted) Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with water (fasted)||122.82|99.01|
72488220|NCT01431274|144505140|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.046|STANDARD_ERROR_OF_MEAN|0.012||0.0001|TWO_SIDED|95.0|0.023|0.07||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (5 µg).~Spatial power covariance structure for within-patient errors."|||0.070|0.023|0.0001
72488221|NCT01431274|144505140|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.024|STANDARD_ERROR_OF_MEAN|0.012||0.0407|TWO_SIDED|95.0|0.001|0.048||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tio+Olo FDC (2.5/5 µg).~Spatial power covariance structure for within-patient errors."|||0.048|0.001|0.0407
72488222|NCT01431274|144505140|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.053|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|0.03|0.077||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.077|0.030|<0.0001
72488223|NCT01431274|144505140|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.012|STANDARD_ERROR_OF_MEAN|0.012||0.3326|TWO_SIDED|95.0|-0.012|0.035||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within-patient errors."|||0.035|-0.012|0.3326
72515272|NCT02475850|144561203|SUPERIORITY||Difference in least-squared means across|0.72|STANDARD_ERROR_OF_MEAN|0.71||0.309|TWO_SIDED|99.0|-1.1|2.54||p \< 0.01 threshold (secondary outcome)|Mixed Models Analysis|random: patients nested within practices; fixed: baseline score, randomization constraint vars, predictors of missingness||||2.54|-1.10|0.309
72515273|NCT02475850|144561204|SUPERIORITY||Least squares means|0.59||||0.528|TWO_SIDED|99.0|-1.8|0.93||p \< 0.01 threshold (secondary outcome)|Mixed Models Analysis|random: patients nested within practices; fixed: baseline score, randomization constraint vars, predictors of missingness||||0.93|-1.80|0.528
72515274|NCT02475850|144561205|SUPERIORITY||Least squares means|-0.9|STANDARD_ERROR_OF_MEAN|0.43||0.037|TWO_SIDED|99.0|-2.0|0.2||p \< 0.01 threshold (secondary outcome)|Mixed Models Analysis|random: patients nested within practices; fixed: baseline score, randomization constraint vars, predictors of missingness|Difference in least-squared means across all follow-up (repeated measures: 12 months/24 months)|||0.20|-2.00|0.037
72515275|NCT02475850|144561206|SUPERIORITY||Least squares means|-1.19|STANDARD_ERROR_OF_MEAN|0.45||0.009|TWO_SIDED|99.0|-2.36|-0.02||p\<0.01 threshold (secondary outcome)|Mixed Models Analysis|random: patients nested within practices; fixed: baseline score, randomization constraint vars, predictors of missingness||||-0.02|-2.36|0.009
72403651|NCT05544786|144313170|OTHER|The analysis used a mixed effect model with sequence, period and treatment as fixed effects and participant within a sequence as a random effect for comparison: powder mixed with infant formula (fasted) group versus tablets group.|Ratio (%) of Adjusted Geometric Mean|140.97|||||TWO_SIDED|90.0|126.57|157.01|||||The ratios (and 90% CIs) are expressed as percentages.|Reference: Nirmatrelvir/ritonavir 300/100 mg tablets (fasted) Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with infant formula (fasted)||157.01|126.57|
72403652|NCT05544786|144313170|OTHER|The analysis used a mixed effect model with treatment as a fixed effect and participant as a random effect for comparison: powder mixed with vanilla pudding (fasted) group versus tablets group.|Ratio (%) of Adjusted Geometric Mean|149.83|||||TWO_SIDED|90.0|132.86|168.96|||||The ratios (and 90% CIs) are expressed as percentages.|Reference: Nirmatrelvir/ritonavir 300/100 mg tablets (fasted) Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with vanilla pudding (fasted)||168.96|132.86|
72403653|NCT05544786|144313170|OTHER|The analysis used a mixed effect model with treatment as a fixed effect and participant as a random effect for comparison: powder mixed with vanilla pudding (fed) group versus tablets group.|Ratio (%) of Adjusted Geometric Mean|147.05|||||TWO_SIDED|90.0|130.4|165.83|||||The ratios (and 90% CIs) are expressed as percentages.|Reference: Nirmatrelvir/ritonavir 300/100 mg tablets (fasted) Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with vanilla pudding (fed)||165.83|130.40|
72403654|NCT05544786|144313171|OTHER|The analysis used a mixed effect model with sequence, period and treatment as fixed effects and participant within a sequence as a random effect for comparison: powder mixed with water (fasted) group versus tablets group.|Ratio (%) of Adjusted Geometric Mean|96.76|||||TWO_SIDED|90.0|87.31|107.23|||||The ratios (and 90% CIs) are expressed as percentages.|Reference: Nirmatrelvir/ritonavir 300/100 mg tablets (fasted) Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with water (fasted)||107.23|87.31|
72403655|NCT05544786|144313171|OTHER|The analysis used a mixed effect model with sequence, period and treatment as fixed effects and participant within a sequence as a random effect for comparison: powder mixed with infant formula (fasted) group versus tablets group.|Ratio (%) of Adjusted Geometric Mean|86.86|||||TWO_SIDED|90.0|78.38|96.26|||||The ratios (and 90% CIs) are expressed as percentages.|Reference: Nirmatrelvir/ritonavir 300/100 mg tablets (fasted) Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with infant formula (fasted)||96.26|78.38|
72403656|NCT05544786|144313171|OTHER|The analysis used a mixed effect model with treatment as a fixed effect and participant as a random effect for comparison: powder mixed with vanilla pudding (fasted) group versus tablets group.|Ratio (%) of Adjusted Geometric Mean|99.29|||||TWO_SIDED|90.0|87.39|112.8|||||The ratios (and 90% CIs) are expressed as percentages.|Reference: Nirmatrelvir/ritonavir 300/100 mg tablets (fasted) Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with vanilla pudding (fasted)||112.80|87.39|
72403657|NCT05544786|144313171|OTHER|The analysis used a mixed effect model with treatment as a fixed effect and participant as a random effect for comparison: powder mixed with vanilla pudding (fed) group versus tablets group.|Ratio (%) of Adjusted Geometric Mean|79.29|||||TWO_SIDED|90.0|70.07|89.73|||||The ratios (and 90% CIs) are expressed as percentages.|Reference: Nirmatrelvir/ritonavir 300/100 mg tablets (fasted) Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with vanilla pudding (fed)||89.73|70.07|
72403658|NCT05544786|144313172|OTHER|The analysis used a mixed effect model with sequence, period and treatment as fixed effects and participant within a sequence as a random effect for comparison: powder mixed with water (fasted) group versus tablets group.|Ratio (%) of Adjusted Geometric Mean|95.92|||||TWO_SIDED|90.0|86.45|106.44|||||The ratios (and 90% CIs) are expressed as percentages.|Reference: Nirmatrelvir/ritonavir 300/100 mg tablets (fasted) Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with water (fasted)||106.44|86.45|
72403659|NCT05544786|144313172|OTHER|The analysis used a mixed effect model with sequence, period and treatment as fixed effects and participant within a sequence as a random effect for comparison: powder mixed with infant formula (fasted) group versus tablets group.|Ratio (%) of Adjusted Geometric Mean|86.5|||||TWO_SIDED|90.0|77.96|95.98|||||The ratios (and 90% CIs) are expressed as percentages.|Reference: Nirmatrelvir/ritonavir 300/100 mg tablets (fasted) Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with infant formula (fasted)||95.98|77.96|
72515276|NCT02475850|144561207|SUPERIORITY||Least squares means|-0.07|STANDARD_ERROR_OF_MEAN|0.51||0.897|TWO_SIDED|99.0|-1.38|1.25||p \<0.01 threshold (secondary outcome)|Mixed Models Analysis|random: patients nested within practices; fixed: baseline score, randomization constraint vars, predictors of missingness|Difference in least-squared means across all follow-up (repeated measures: 12 months, 24 months)|||1.25|-1.38|0.897
72515277|NCT01746940|144561208|SUPERIORITY_OR_OTHER|||||||0.1088||||||One-sided p-value|Fisher Exact|||The null hypothesis is that the proportions of treatment group successes are equal.||||0.1088
72403660|NCT05544786|144313172|OTHER|The analysis used a mixed effect model with treatment as a fixed effect and participant as a random effect for comparison: powder mixed with vanilla pudding (fasted) group versus tablets group.|Ratio (%) of Adjusted Geometric Mean|88.29|||||TWO_SIDED|90.0|72.97|106.83|||||The ratios (and 90% CIs) are expressed as percentages.|Reference: Nirmatrelvir/ritonavir 300/100 mg tablets (fasted) Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with vanilla pudding (fasted)||106.83|72.97|
72403661|NCT05544786|144313172|OTHER|The analysis used a mixed effect model with treatment as a fixed effect and participant as a random effect for comparison: powder mixed with vanilla pudding (fed) group versus tablets group.|Ratio (%) of Adjusted Geometric Mean|77.49|||||TWO_SIDED|90.0|64.04|93.76|||||The ratios (and 90% CIs) are expressed as percentages.|Reference: Nirmatrelvir/ritonavir 300/100 mg tablets (fasted) Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with vanilla pudding (fed)||93.76|64.04|
72403662|NCT05544786|144313173|OTHER|The analysis used a mixed effect model with sequence, period and treatment as fixed effects and participant within a sequence as a random effect for comparison: powder mixed with water (fasted) group versus tablets group.|Ratio (%) of Adjusted Geometric Mean|101.92|||||TWO_SIDED|90.0|87.71|118.44|||||The ratios (and 90% CIs) are expressed as percentages.|Reference: Nirmatrelvir/ritonavir 300/100 mg tablets (fasted) Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with water (fasted)||118.44|87.71|
72515278|NCT01746940|144561208|SUPERIORITY_OR_OTHER|||||||0.0005||||||One-sided p-value|Fisher Exact|||The null hypothesis is that the proportions of treatment group successes are equal.||||0.0005
72515279|NCT02700919|144561223|SUPERIORITY|||||||0.012|||||||Log Rank|||Change from Baseline on Day 7||||0.012
72515280|NCT02700919|144561223|SUPERIORITY||||||<|0.001|||||||Log Rank|||Change from Baseline on Day 7||||<0.001
72403663|NCT05544786|144313173|OTHER|The analysis used a mixed effect model with sequence, period and treatment as fixed effects and participant within a sequence as a random effect for comparison: powder mixed with infant formula (fasted) group versus tablets group.|Ratio (%) of Adjusted Geometric Mean|92.4|||||TWO_SIDED|90.0|79.52|107.38|||||The ratios (and 90% CIs) are expressed as percentages.|Reference: Nirmatrelvir/ritonavir 300/100 mg tablets (fasted) Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with infant formula (fasted)||107.38|79.52|
72403664|NCT05544786|144313173|OTHER|The analysis used a mixed effect model with treatment as a fixed effect and participant as a random effect for comparison: powder mixed with vanilla pudding (fasted) group versus tablets group.|Ratio (%) of Adjusted Geometric Mean|97.04|||||TWO_SIDED|90.0|78.4|120.1|||||The ratios (and 90% CIs) are expressed as percentages.|Reference: Nirmatrelvir/ritonavir 300/100 mg tablets (fasted) Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with vanilla pudding (fasted)||120.10|78.40|
72403665|NCT05544786|144313173|OTHER|The analysis used a mixed effect model with treatment as a fixed effect and participant as a random effect for comparison: powder mixed with vanilla pudding (fed) group versus tablets group.|Ratio (%) of Adjusted Geometric Mean|70.45|||||TWO_SIDED|90.0|56.92|87.19|||||The ratios (and 90% CIs) are expressed as percentages.|Reference: Nirmatrelvir/ritonavir 300/100 mg tablets (fasted) Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with vanilla pudding (fed)||87.19|56.92|
72403666|NCT05544786|144313174|OTHER|The analysis used a mixed effect model with sequence, period and treatment as fixed effects and participant within a sequence as a random effect.|Ratio (%) of Adjusted Geometric Mean|96.5|||||TWO_SIDED|90.0|90.08|103.37|||||The ratios (and 90% CIs) are expressed as percentages.|Reference: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with vanilla pudding (fasted) Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with vanilla pudding (fed)||103.37|90.08|
72403667|NCT05544786|144313175|OTHER|The analysis used a mixed effect model with sequence, period and treatment as fixed effects and participant within a sequence as a random effect.|Ratio (%) of Adjusted Geometric Mean|96.63|||||TWO_SIDED|90.0|90.13|103.59|||||The ratios (and 90% CIs) are expressed as percentages.|Reference: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with vanilla pudding (fasted) Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with vanilla pudding (fed)||103.59|90.13|
72403668|NCT05544786|144313176|OTHER|The analysis used a mixed effect model with sequence, period and treatment as fixed effects and participant within a sequence as a random effect.|Ratio (%) of Adjusted Geometric Mean|98.15|||||TWO_SIDED|90.0|87.28|110.36|||||The ratios (and 90% CIs) are expressed as percentages.|Reference: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with vanilla pudding (fasted) Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with vanilla pudding (fed)||110.36|87.28|
72403669|NCT05544786|144313177|OTHER|The analysis used a mixed effect model with sequence, period and treatment as fixed effects and participant within a sequence as a random effect.|Ratio (%) of Adjusted Geometric Mean|78.49|||||TWO_SIDED|90.0|72.42|85.07|||||The ratios (and 90% CIs) are expressed as percentages.|Reference: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with vanilla pudding (fasted) Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with vanilla pudding (fed)||85.07|72.42|
72403670|NCT05544786|144313178|OTHER|The analysis used a mixed effect model with sequence, period and treatment as fixed effects and participant within a sequence as a random effect.|Ratio (%) of Adjusted Geometric Mean|87.77|||||TWO_SIDED|90.0|69.45|110.92|||||The ratios (and 90% CIs) are expressed as percentages.|Reference: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with vanilla pudding (fasted) Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with vanilla pudding (fed)||110.92|69.45|
72403671|NCT05544786|144313179|OTHER|The analysis used a mixed effect model with sequence, period and treatment as fixed effects and participant within a sequence as a random effect.|Ratio (%) of Adjusted Geometric Mean|72.6|||||TWO_SIDED|90.0|56.87|92.68|||||The ratios (and 90% CIs) are expressed as percentages.|Reference: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with vanilla pudding (fasted) Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with vanilla pudding (fed)||92.68|56.87|
72403672|NCT00744627|144313257|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.81|STANDARD_ERROR_OF_MEAN|0.981|<|0.001|TWO_SIDED|95.0|-5.74|-1.88||Pre-specified sequential statistical testing procedure indicates that when p-value \<0.05, hierarchical testing continues.|Mixed model for repeated measurements|P-values were from a MMRM with Baseline-by-week, center, week and week-by-treatment as factors in the analysis.||P-values were tested at the 5% level of significance (ie, statistical significance if P\<0.05). To control for multiplicity, a pre-specified sequential testing procedure was applied to compare 5 mg vortioxetine to placebo; as soon as an endpoint was non-significant at 0.05, the testing procedure stopped for all subsequent endpoints.||-1.88|-5.74|<0.001
72403673|NCT00744627|144313258|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.3|STANDARD_ERROR_OF_MEAN|0.555|<|0.001|TWO_SIDED|95.0|-3.39|-1.2||Pre-specified sequential statistical testing procedure indicates that when p-value \<0.05, hierarchical testing continues.|Mixed model for repeated measurements|P-values were from a MMRM with Baseline-by-week, center, week and week-by-treatment as factors in the analysis||||-1.20|-3.39|<0.001
72403674|NCT00744627|144313259|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.46|STANDARD_ERROR_OF_MEAN|0.138|<|0.001|TWO_SIDED|95.0|-0.73|-0.19||Pre-specified sequential statistical testing procedure indicates that when p-value \<0.05, hierarchical testing continues.|Mixed model for repeated measurements|P-values were from a MMRM with Baseline-by-week, center, week and week-by-treatment as factors in the analysis.||||-0.19|-0.73|<0.001
72515281|NCT02700919|144561223|SUPERIORITY|||||||0.102|||||||Log Rank|||Change from Baseline on Day 7||||0.102
72515282|NCT02700919|144561223|SUPERIORITY||Mean Difference (Final Values)|0.027||||0.507|TWO_SIDED|95.0|-0.053|0.107|||Mixed Models Analysis|||Day 7||0.107|-0.053|0.507
72515283|NCT02700919|144561223|SUPERIORITY||Mean Difference (Final Values)|0.058||||0.148|TWO_SIDED|95.0|-0.021|0.136|||Mixed Models Analysis|||Day 7||0.136|-0.021|0.148
72515284|NCT02700919|144561223|SUPERIORITY||Mean Difference (Final Values)|-0.031||||0.443|TWO_SIDED|95.0|-0.109|0.048|||Mixed Models Analysis|||Day 7||0.048|-0.109|0.443
72515285|NCT02700919|144561227|SUPERIORITY|||||||0.399|||||||Log Rank|||||||0.399
72515286|NCT02700919|144561227|SUPERIORITY|||||||0.091|||||||Log Rank|||||||0.091
72515287|NCT02700919|144561227|SUPERIORITY|||||||0.437|||||||Log Rank|||||||0.437
72515288|NCT02700919|144561231|SUPERIORITY|||||||0.72|||||||Log Rank|||||||0.720
72515289|NCT02700919|144561231|SUPERIORITY|||||||0.298|||||||Log Rank|||||||0.298
72515290|NCT02700919|144561231|SUPERIORITY|||||||0.47|||||||Log Rank|||||||0.470
72624281|NCT00863304|144778627|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.56|STANDARD_ERROR_OF_MEAN|0.24||0.017|TWO_SIDED|95.0|-1.03|-0.1||P-value was based on pairwise comparisons.|ANCOVA|||Week 8: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.10|-1.03|0.017
72624282|NCT00863304|144778627|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.52|STANDARD_ERROR_OF_MEAN|0.24||0.027|TWO_SIDED|95.0|-0.99|-0.06||P-value was based on pairwise comparisons.|ANCOVA|||Week 8: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.06|-0.99|0.027
72403675|NCT00744627|144313260|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.96|STANDARD_ERROR_OF_MEAN|0.901||0.031|TWO_SIDED|95.0|-3.74|-0.18||Pre-specified sequential statistical testing procedure indicates that when p-value \<0.05, hierarchical testing continues.|Mixed model for repeated measurements|P-values were from a MMRM with Baseline-by-week, center, week and week-by-treatment as factors in the analysis.||||-0.18|-3.74|0.031
72403676|NCT00744627|144313261|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.393|||<|0.001|TWO_SIDED|95.0|1.496|3.83||Pre-specified sequential statistical testing procedure indicates that when p-value \<0.05, hierarchical testing continues.|Regression, Logistic|Logistic regression with explanatory variables for treatment and Baseline HAM-A score.||||3.830|1.496|<0.001
72403677|NCT00744627|144313262|SUPERIORITY_OR_OTHER||LS Mean Difference|-5.1|STANDARD_ERROR_OF_MEAN|1.267|<|0.001|TWO_SIDED|95.0|-7.61|-2.6||Pre-specified sequential statistical testing procedure indicates that when p-value \<0.05, hierarchical testing continues.|Mixed model for repeated measurements|P-values were from a MMRM with Baseline-by-week, center, week and week-by-treatment as factors in the analysis.||||-2.60|-7.61|<0.001
72403678|NCT00744627|144313263|SUPERIORITY_OR_OTHER||LS Mean Difference|8.78|STANDARD_ERROR_OF_MEAN|2.774||0.002|TWO_SIDED|95.0|3.32|14.25||SF-36 social functioning subscore was the last endpoint to be tested in the hierarchical testing sequence.|Mixed model for repeated measurements|P-values were from a MMRM with Baseline-by-week, center, week and week-by-treatment as factors in the analysis.||Results presented are for the number of participants at week 8 only.||14.25|3.32|0.002
72488224|NCT01431274|144505140|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.029|STANDARD_ERROR_OF_MEAN|0.012||0.0151|TWO_SIDED|95.0|0.006|0.053||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (2.5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within-patient errors."|||0.053|0.006|0.0151
72488225|NCT01431274|144505140|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.018|STANDARD_ERROR_OF_MEAN|0.012||0.1421|TWO_SIDED|95.0|-0.041|0.006||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.006|-0.041|0.1421
72568231|NCT00899470|144668037|NON_INFERIORITY_OR_EQUIVALENCE|If no difference between bioavailabilities of metformin from FDC tablet vs. co-administration of saxagliptin tablet and metformin (fed), then 20 subjects provided 99% power to conclude BE with respect to AUC(INF) of metformin. If 5% difference then 20 subjects provided 95% power to conclude BE with respect to AUC(INF) of metformin.|Geometric Mean Ratio, Test vs. Reference|1.042|||||TWO_SIDED|90.0|0.981|1.108|||Mixed Models Analysis|Bioequivalence=90% CIs for the test|For AUC(0-T) of metformin, the point estimate and 90% CI were calculated for the ratio of the geometric mean of the Test formulation in fed state: the geometric mean of the Reference formulation in fed state|To demonstrate BE of FDC tablets (Test) versus co-administration of saxagliptin and metformin IR tablets (Reference) formulations in fed state, linear mixed model analysis was performed on log\[AUC(0-T)\] of metformin. Factors in the model were sequence, period and treatment as fixed effects, and participant within sequence as a random effect.||1.108|0.981|
72577109|NCT00580788|144680822|NON_INFERIORITY_OR_EQUIVALENCE|The study was designed as a standard dose-escalation study, dose-finding pilot study. The primary outcome measures were safety (hypercalcemia, hypophosphatemia and symptoms/hemodynamic measurements). A modified Fibronacci dose-escalation scheme was employed.||||||0.002|TWO_SIDED|||||the reported p-value corresponds to the increase comapred to baseline over time (days 2-8) in the PTHrP 4 pmol group|Mixed Models Analysis|The level of statistical significance was set at .05 (two-tailed)||||||.002
72488226|NCT01431274|144505141|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.693|STANDARD_ERROR_OF_MEAN|0.553||0.0022|TWO_SIDED|95.0|-2.778|-0.608||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within-patient errors."|||-0.608|-2.778|0.0022
72577110|NCT02045147|144680859|OTHER||Mean Difference (Final Values)|2.8|STANDARD_ERROR_OF_MEAN|3.82||0.463|TWO_SIDED|95.0|-4.98|10.65|||t-test, 2 sided|||||10.65|-4.98|0.463
72624283|NCT00863304|144778627|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.31|STANDARD_ERROR_OF_MEAN|0.24||0.19|TWO_SIDED|95.0|-0.78|0.15||P-value was based on pairwise comparisons.|ANCOVA|||Week 8: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||0.15|-0.78|0.190
72488227|NCT01431274|144505141|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.233|STANDARD_ERROR_OF_MEAN|0.551||0.0252|TWO_SIDED|95.0|-2.313|-0.153||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Tiotropium (5 μg).~Spatial power covariance structure for within-patient errors."|||-0.153|-2.313|0.0252
72488228|NCT01431274|144505141|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.031|STANDARD_ERROR_OF_MEAN|0.552||0.062|TWO_SIDED|95.0|-2.113|0.052||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within-patient errors."|||0.052|-2.113|0.0620
72488229|NCT01431274|144505141|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.456|STANDARD_ERROR_OF_MEAN|0.548||0.4051|TWO_SIDED|95.0|-1.531|0.618||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.618|-1.531|0.4051
72488230|NCT01431274|144505141|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.571|STANDARD_ERROR_OF_MEAN|0.55||0.2988|TWO_SIDED|95.0|-1.649|0.507||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (5 µg).~Spatial power covariance structure for within-patient errors."|||0.507|-1.649|0.2988
72488231|NCT01431274|144505141|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.662|STANDARD_ERROR_OF_MEAN|0.545||0.2249|TWO_SIDED|95.0|-1.731|0.407||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.407|-1.731|0.2249
72488232|NCT01431274|144505141|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.118|STANDARD_ERROR_OF_MEAN|0.549||0.0418|TWO_SIDED|95.0|-2.195|-0.042||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||-0.042|-2.195|0.0418
72488233|NCT01431274|144505141|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.46|STANDARD_ERROR_OF_MEAN|0.557||0.4097|TWO_SIDED|95.0|-1.552|0.633||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (2.5 µg) versus Olodaterol (5 µg)~Spatial power covariance structure for within-patient errors."|||0.633|-1.552|0.4097
72488234|NCT01431274|144505141|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.575|STANDARD_ERROR_OF_MEAN|0.556||0.3013|TWO_SIDED|95.0|-1.664|0.515||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (2.5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within-patient errors."|||0.515|-1.664|0.3013
72488235|NCT01431274|144505141|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.115|STANDARD_ERROR_OF_MEAN|0.554||0.8355|TWO_SIDED|95.0|-0.97|1.2||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (2.5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within-patient errors."|||1.200|-0.970|0.8355
72488236|NCT01431274|144505142|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.42|STANDARD_ERROR_OF_MEAN|0.135||0.0019|TWO_SIDED|95.0|0.155|0.684||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within-patient errors."|||0.684|0.155|0.0019
72515291|NCT01517412|144561256|NON_INFERIORITY_OR_EQUIVALENCE|A step-down procedure was used to control the type I error: non-inferiority of lixisenatide prior to the main meal of the day versus lixisenatide prior to breakfast was tested first. If non-inferiority was established, then a test of superiority of lixisenatide prior to the main meal of the day over lixisenatide prior to breakfast was to be performed. The non-inferiority was assessed using upper bound of 2-sided 95% CI at a level of ≤0.4%.|Least square (LS) mean difference|0.09|STANDARD_ERROR_OF_MEAN|0.079|||TWO_SIDED|95.0|-0.067|0.242|||||Lixisenatide Main Meal vs Lixisenatide Breakfast|Analysis was performed using analysis of covariance (ANCOVA) model with treatment groups, randomization strata of screening HbA1c (\<8.0%, ≥8.0%), randomization strata of main meal of the day and country as fixed effects and baseline HbA1c value as a covariate.||0.242|-0.067|
72515292|NCT01517412|144561256|SUPERIORITY_OR_OTHER||LS Mean Difference|0.09|STANDARD_ERROR_OF_MEAN|0.079||0.2664|TWO_SIDED|||||Threshold for significance at 0.05 level.|ANCOVA||Lixisenatide Main Meal vs Lixisenatide Breakfast|Analysis was performed using analysis of covariance (ANCOVA) model with treatment groups, randomization strata of screening HbA1c (\<8.0%, ≥8.0%), randomization strata of main meal of the day and country as fixed effects and baseline HbA1c value as a covariate. A step-down procedure was used to control the type I error. The superiority was assessed by comparing the p-value at significance level = 0.05.||||0.2664
72577111|NCT02045147|144680859|OTHER||Mean Difference (Final Values)|1.6|STANDARD_ERROR_OF_MEAN|3.4||0.634|TWO_SIDED|95.0|-5.23|8.49|||t-test, 2 sided|||||8.49|-5.23|0.634
72577112|NCT02045147|144680859|OTHER||Mean Difference (Final Values)|4.8|STANDARD_ERROR_OF_MEAN|4.15||0.259|TWO_SIDED|95.0|-3.74|13.32|||t-test, 2 sided|||||13.32|-3.74|0.259
72403679|NCT00323492|144313297|SUPERIORITY_OR_OTHER||Median Difference (Net)|-0.42||||0.034||95.0|-0.86|-0.03||No adjustments for multiple comparisons were made.|Wilcoxon Rank Sum test|No adjustments were applied.|Difference is for Truvada minus Maintain Baseline Regimen. The non-parametric estimate of the difference between groups (Hodges-Lehmann) and its 95% confidence intervals (Moses) are provided.|Null Hypothesis: changes from baseline in the two treatment groups are equal. Alternative Hypothesis: changes from baseline in the two treatment groups are different (two sided).||-0.03|-0.86|0.034
72403680|NCT00323492|144313298|SUPERIORITY_OR_OTHER||Median Difference (Net)|-0.36||||0.031||95.0|-0.67|-0.03||No adjustments for multiple comparisons were made.|Wilcoxon Rank Sum text|No adjustments were made.|Difference is for Truvada minus Maintain Baseline Regimen. The non-parametric estimate of the difference between groups (Hodges-Lehmann) and its 95% confidence intervals (Moses) are provided.|Null Hypothesis: changes from baseline in the two treatment groups are equal. Alternative Hypothesis: changes from baseline in the two treatment groups are different (two sided).||-0.03|-0.67|0.031
72403681|NCT00323492|144313299|SUPERIORITY_OR_OTHER||Median Difference (Net)|-0.1||||0.009||95.0|-0.18|-0.02||No adjustments for multiple comparisons were made.|Wilcoxon Rank Sum test|No adjustments were made.|Difference is for Truvada minus Maintain Baseline Regimen. The non-parametric estimate of the difference between groups (Hodges-Lehmann) and its 95% confidence intervals (Moses) are provided.|Null Hypothesis: changes from baseline in the two treatment groups are equal. Alternative Hypothesis: changes from baseline in the two treatment groups are different (two sided).||-0.02|-0.18|0.009
72403682|NCT00323492|144313300|SUPERIORITY_OR_OTHER||Median Difference (Net)|-0.64|||<|0.001||95.0|-1.01|-0.27||No adjustments for multiple comparisons were made.|Wicoxon Rank Sum test|no adjustments were made.|Difference is for Truvada minus Maintain Baseline Regimen. The non-parametric estimate of the difference between groups (Hodges-Lehmann) and its 95% confidence intervals (Moses) are provided.|Null Hypothesis: changes from baseline in the two treatment groups are equal. Alternative Hypothesis: changes from baseline in the two treatment groups are different (two sided).||-0.27|-1.01|< 0.001
72403683|NCT00323492|144313301|SUPERIORITY_OR_OTHER||Median Difference (Net)|-0.1||||0.51||95.0|-0.44|0.19||No adjustments for multiple comparisons were made.|Wilcoxon Rank Sum test|No adjustments were made.|Difference is for Truvada minus Maintain Baseline Regimen. The non-parametric estimate of the difference between groups (Hodges-Lehmann) and its 95% confidence intervals (Moses) are provided.|Null Hypothesis: changes from baseline in the two treatment groups are equal. Alternative Hypothesis: changes from baseline in the two treatment groups are different (two sided).||0.19|-0.44|0.51
72403684|NCT00323492|144313302|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.0||||0.79||95.0|-0.03|0.02||No adjustments for multiple comparisons were made.|Wilcoxon Rank Sum test|No adjustments were made.|Difference is for Truvada minus Maintain Baseline Regimen. The non-parametric estimate of the difference between groups (Hodges-Lehmann) and its 95% confidence intervals (Moses) are provided.|Null Hypothesis: changes from baseline in the two treatment groups are equal. Alternative Hypothesis: changes from baseline in the two treatment groups are different (two sided).||0.02|-0.03|0.79
72403685|NCT00323492|144313303|SUPERIORITY_OR_OTHER|||||||0.86||95.0||||No adjustments for multiple comparisons were made.|Wilcoxon Rank Sum test|No adjustments were made.||Null Hypothesis: changes from baseline in the two treatment groups are equal. Alternative Hypothesis: changes from baseline in the two treatment groups are different (two sided).||||0.86
72403686|NCT00323492|144313305|SUPERIORITY_OR_OTHER|||||||0.65||95.0||||No adjustments for multiple comparisons were made.|Wilcoxon Rank Sum test|No adjustments were made.||Null Hypothesis: changes from baseline in the two treatment groups are equal. Alternative Hypothesis: changes from baseline in the two treatment groups are different (two sided).||||0.65
72403687|NCT00323492|144313306|SUPERIORITY_OR_OTHER|||||||0.11||95.0||||No adjustments were made.|Wilcoxon Signed Rank test|No adjustments were made.||Null Hypothesis: no indication of shift from 0 in distribution of change from baseline. Alternative Hypothesis: shift from 0 is observed in distribution of change from baseline.||||0.11
72403688|NCT00323492|144313306|SUPERIORITY_OR_OTHER|||||||0.34||95.0||||No adjustments were made.|Wilcoxon Signed Rank test|No adjustments were made.||Null Hypothesis: no indication of shift from 0 in distribution of change from baseline. Alternative Hypothesis: shift from 0 is observed in distribution of change from baseline.||||0.34
72403689|NCT00323492|144313307|SUPERIORITY_OR_OTHER|||||||1||95.0||||No adjustments were made.|Fisher Exact|No adjustments were made.||Null Hypothesis: treatment is not associated with the observed virologic response. Alternative Hypothesis: treatment is associated with the observed virologic response||||1.00
72403690|NCT02486042|144313310|OTHER|T-test for equality in means. The p-value threshold for significance was p \< 0.05.||||||0.22|||||||t-test, 2 sided|||Null hypothesis: there was no difference in the average dCt values for relative gene expression of STAT-3 in T0 blood samples in the Standard of Care versus Omegaven group||||0.22
72515293|NCT01253187|144561266|NON_INFERIORITY_OR_EQUIVALENCE|A sample size of 6 volunteers per sequence was considered sufficient to establish bioequivalence, id est the 90%-confidence interval for the mean ratio is located completely within the equivalence interval limits of 80% and 125%.|mean ratio|106.03||||||90.0|98.86|113.72||The equivalence test was done using a 90% confidence interval, no p-value was to be calculated.|ANOVA||Point estimate for the ratio \[(EE20/DRSP/L-5-MTHF Ca) / YAZ\]. Bioequivalence is established if the 90% confidence interval fall within the equivalence interval limits of 80-125%|38 volunteers qualified for statistical analysis of BE whereas all 39 volunteers with valid concentration time profiles were included in the pharmacokinetic (PK) analysis||113.72|98.86|
72515294|NCT01253187|144561267|NON_INFERIORITY_OR_EQUIVALENCE|A sample size of 6 volunteers per sequence was considered sufficient to establish bioequivalence, id est the 90%-confidence interval for the mean ratio is located completely within the equivalence interval limits of 80% and 125%.|mean ratio|103.47||||||90.0|99.16|107.98||The equivalence test was done using a 90% confidence interval, no p-value was to be calculated.|ANOVA||Point estimate for the ratio \[(EE20/DRSP/L-5-MTHF Ca) / YAZ\]. Bioequivalence is established if the 90% confidence interval fall within the equivalence interval limits of 80-125%|38 volunteers qualified for statistical analysis of BE whereas all 39 volunteers with valid concentration time profiles were included in the pharmacokinetic (PK) analysis||107.98|99.16|
72403691|NCT02486042|144313310|OTHER|T-test for equality of means. The p-value threshold for significance was p \< 0.05.||||||0.15|||||||t-test, 2 sided|||Null hypothesis: there was no difference in the average dCt values for relative gene expression of PPAR-gamma in T0 blood samples in the Standard of Care versus Omegaven group||||0.15
72403692|NCT02486042|144313310|OTHER|T-test for equality of means. The p-value threshold for significance was p \< 0.05.||||||0.78|||||||t-test, 2 sided|||Null hypothesis: there was no difference in the average dCt values for relative gene expression of STC-1 in T0 blood samples in the Standard of Care versus Omegaven group||||0.78
72488237|NCT01431274|144505142|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.356|STANDARD_ERROR_OF_MEAN|0.135||0.0082|TWO_SIDED|95.0|0.092|0.619||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Tiotropium (5 μg).~Spatial power covariance structure for within-patient errors."|||0.619|0.092|0.0082
72515295|NCT01253187|144561268|NON_INFERIORITY_OR_EQUIVALENCE|A sample size of 6 volunteers per sequence was considered sufficient to establish bioequivalence, id est the 90%-confidence interval for the mean ratio is located completely within the equivalence interval limits of 80% and 125%.|mean ratio|105.24||||||90.0|97.3|113.83||The equivalence test was done using a 90% confidence interval, no p-value was to be calculated.|ANOVA||Point estimate for the ratio \[(EE20/DRSP/L-5-MTHF Ca) / YAZ\]. Bioequivalence is established if the 90% confidence interval fall within the equivalence interval limits of 80-125%|33 volunteers qualified for statistical analysis of BE whereas all 35 (YAZ) and 36 (EE20/DRSP/L-5-MTHF Ca) volunteers with valid concentration time profiles were included in the pharmacokinetic (PK) analysis||113.83|97.30|
72515296|NCT01253187|144561269|NON_INFERIORITY_OR_EQUIVALENCE|A sample size of 6 volunteers per sequence was considered sufficient to establish bioequivalence, id est the 90%-confidence interval for the mean ratio is located completely within the equivalence interval limits of 80% and 125%.|mean ratio|100.48||||||90.0|97.28|103.79||The equivalence test was done using a 90% confidence interval, no p-value was to be calculated.|ANOVA||Point estimate for the ratio \[(EE20/DRSP/L-5-MTHF Ca) / YAZ\]. Bioequivalence is established if the 90% confidence interval fall within the equivalence interval limits of 80-125%|33 volunteers qualified for statistical analysis of BE whereas all 35 (YAZ) and 36 (EE20/DRSP/L-5-MTHF Ca) volunteers with valid concentration time profiles were included in the pharmacokinetic (PK) analysis||103.79|97.28|
72568232|NCT00899470|144668038|NON_INFERIORITY_OR_EQUIVALENCE|If no difference between bioavailabilities of metformin from FDC tablet vs. co-administration of saxagliptin tablet and metformin (fasted ), then 20 subjects provided 99% power to conclude BE with respect to AUC(INF) of metformin. If 5% difference then 20 subjects provided 95% power to conclude BE with respect to AUC(INF) of metformin.|Geometric Mean Ratio, Test vs. Reference|1.029|||||TWO_SIDED|90.0|0.973|1.088|||Mixed Models Analysis|Bioequivalence=90% CIs for the test|For AUC(INF) of metformin, the point estimate and 90% CI were calculated for the ratio of the geometric mean of the Test formulation in fasted state: the geometric mean of the Reference formulation in fasted state|To demonstrate BE of FDC tablets (Test) versus co-administration of saxagliptin and metformin IR tablets (Reference) formulations in fasted state, linear mixed model analysis was performed on log\[AUC(INF)\] of metformin. Factors in the model were sequence, period and treatment as fixed effects, and participant within sequence as a random effect.||1.088|0.973|
72403693|NCT02486042|144313314|OTHER|T-test for equality of means. The p-value threshold for significance was p \< 0.05.||||||0.43|||||||t-test, 2 sided|||Null hypothesis: there was no difference in the average dCt values for relative gene expression of STAT-3 in T1 blood samples in the Standard of Care versus Omegaven group||||0.43
72403694|NCT02486042|144313314|OTHER|T-test for equality of means. The p-value threshold for significance was p \< 0.05.||||||0.44|||||||t-test, 2 sided|||Null hypothesis: there was no difference in the average dCt values for relative gene expression of PPAR-gamma in T1 blood samples in the Standard of Care versus Omegaven group||||0.44
72488238|NCT01431274|144505142|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.416|STANDARD_ERROR_OF_MEAN|0.135||0.002|TWO_SIDED|95.0|0.152|0.681||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within-patient errors."|||0.681|0.152|0.0020
72488239|NCT01431274|144505142|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.29|STANDARD_ERROR_OF_MEAN|0.134||0.0307|TWO_SIDED|95.0|0.027|0.554||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.554|0.027|0.0307
72488240|NCT01431274|144505142|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.352|STANDARD_ERROR_OF_MEAN|0.135||0.0088|TWO_SIDED|95.0|0.089|0.616||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (5 µg).~Spatial power covariance structure for within-patient errors."|||0.616|0.089|0.0088
72488241|NCT01431274|144505142|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.003|STANDARD_ERROR_OF_MEAN|0.134||0.9801|TWO_SIDED|95.0|-0.259|0.266||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tio+Olo FDC (2.5/5 µg).~Spatial power covariance structure for within-patient errors."|||0.266|-0.259|0.9801
72488242|NCT01431274|144505142|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.294|STANDARD_ERROR_OF_MEAN|0.134||0.0289|TWO_SIDED|95.0|0.03|0.557||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.557|0.030|0.0289
72568233|NCT00899470|144668038|NON_INFERIORITY_OR_EQUIVALENCE|If no difference between bioavailabilities of metformin from FDC tablet vs. co-administration of saxagliptin tablet and metformin (fed), then 20 subjects provided 99% power to conclude BE with respect to AUC(INF) of metformin. If 5% difference then 20 subjects provided 95% power to conclude BE with respect to AUC(INF) of metformin.|Geometric Mean Ratio, Test vs. Reference|1.042|||||TWO_SIDED|90.0|0.986|1.102|||Mixed Models Analysis|Bioequivalence=90% CIs for the test|For AUC(INF) of metformin, the point estimate and 90% confidence interval (CI) were calculated for the ratio of the geometric mean of the Test formulation in fed state: the geometric mean of the Reference formulation in fed state|To demonstrate BE of FDC tablets (Test) versus co-administration of saxagliptin and metformin IR tablets (Reference) formulations in fed state, linear mixed model analysis was performed on log\[AUC(INF)\] of metformin. Factors in the model were sequence, period and treatment as fixed effects, and participant within sequence as a random effect.||1.102|0.986|
72568234|NCT02192164|144668049|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.757334|STANDARD_ERROR_OF_MEAN|1.594019|||TWO_SIDED|95.0|-5.916307|0.401638||||||||0.401638|-5.916307|
72568235|NCT02192164|144668050|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.911449|STANDARD_ERROR_OF_MEAN|1.426517|||TWO_SIDED|95.0|-3.73847|1.915572||||||||1.915572|-3.73847|
72568236|NCT00359788|144668060|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.106|||<|0.0001|TWO_SIDED|95.0|0.055|0.157|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.157|0.055|<0.0001
72568237|NCT00359788|144668061|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin = 0.05 liters|Mean Difference (Final Values)|0.02||||0.0042||95.0|-0.032|0.072|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.072|-0.032|0.0042
72568238|NCT00359788|144668062|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.145|||<|0.0001||95.0|0.098|0.193|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.193|0.098|<0.0001
72568239|NCT00359788|144668063|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.08|||<|0.0001||95.0|-0.114|-0.046|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||-0.046|-0.114|<0.0001
72568240|NCT00359788|144668064|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.054||||0.0447||95.0|0.001|0.106|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.106|0.001|0.0447
72403695|NCT02486042|144313314|OTHER|T-test for equality of means. The p-value threshold for significance was p \< 0.05.||||||0.5|||||||t-test, 2 sided|||Null hypothesis: there was no difference in the average dCt values for relative gene expression of STC-1 in T1 blood samples in the Standard of Care versus Omegaven group||||0.50
72568241|NCT00359788|144668065|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.131|||<|0.0001||95.0|-0.171|-0.092|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||-0.092|-0.171|<0.0001
72568242|NCT00359788|144668066|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.152|||<|0.0001||95.0|-0.19|-0.113|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||-0.113|-0.19|<0.0001
72568243|NCT00359788|144668067|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.133|||<|0.0001||95.0|-0.175|-0.091|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||-0.091|-0.175|<0.0001
72403696|NCT02486042|144313315|OTHER|T-test for equality of means. The p-value threshold for significance was p \< 0.05.||||||0.001|||||||t-test, 2 sided|||Null hypothesis: there was no difference in the average dCt values for relative gene expression of STAT-3 in T2 blood samples in the Standard of Care versus Omegaven group||||0.001
72568244|NCT00359788|144668068|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.175||||0.0015||95.0|0.067|0.283|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.283|0.067|0.0015
72568245|NCT00359788|144668069|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.011||||0.835||95.0|-0.092|0.114|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.114|-0.092|0.835
72568246|NCT00359788|144668070|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.278|||<|0.0001||95.0|0.178|0.379|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.379|0.178|<0.0001
72568247|NCT00359788|144668071|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.157|||<|0.0001||95.0|-0.236|-0.078|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||-0.078|-0.236|<0.0001
72568248|NCT00359788|144668072|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.039||||0.4386||95.0|-0.059|0.137|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.137|-0.059|0.4386
72568249|NCT00359788|144668073|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.282||||0.0001||95.0|-0.374|-0.191|||ANCOVA|||||-0.191|-0.374|0.0001
72568250|NCT00359788|144668074|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.361|||<|0.0001||95.0|-0.449|-0.274|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||-0.274|-0.449|<0.0001
72568251|NCT00359788|144668075|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.286|||<|0.0001||95.0|-0.375|-0.196|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||-0.196|-0.375|<0.0001
72568252|NCT00359788|144668076|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.175|||<|0.0001||95.0|-0.207|-0.142|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||-0.142|-0.207|<0.0001
72568253|NCT00359788|144668077|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.168|||<|0.0001||95.0|-0.205|-0.131|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||-0.131|-0.205|<0.0001
72568254|NCT00359788|144668078|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.182|||<|0.0001||95.0|-0.221|-0.143|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||-0.143|-0.221|<0.0001
72568255|NCT00359788|144668079|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.136|||<|0.0001||95.0|-0.175|-0.097|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||-0.097|-0.175|<0.0001
72568256|NCT00359788|144668080|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.084|||<|0.0001||95.0|-0.125|-0.044|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||-0.044|-0.125|<0.0001
72403697|NCT02486042|144313315|OTHER|T-test for equality of means. The p-value threshold for significance was p \< 0.05.||||||0.001|||||||t-test, 2 sided|||Null hypothesis: there was no difference in the average dCt values for relative gene expression of PPAR-gamma in T2 blood samples in the Standard of Care versus Omegaven group||||0.001
72403698|NCT02486042|144313315|OTHER|T-test for equality of means. The p-value threshold for significance was p \< 0.05.||||||0.01|||||||t-test, 2 sided|||Null hypothesis: there was no difference in the average dCt values for relative gene expression of STC-1 in T2 blood samples in the Standard of Care versus Omegaven group||||0.01
72515297|NCT01253187|144561270|NON_INFERIORITY_OR_EQUIVALENCE|A sample size of 6 volunteers per sequence was considered sufficient to establish bioequivalence, id est the 90%-confidence interval for the mean ratio is located completely within the equivalence interval limits of 80% and 125%.|mean ratio|99.88||||||90.0|91.24|109.34||The equivalence test was done using a 90% confidence interval, no p-value was to be calculated.|ANOVA||Point estimate for the ratio \[(EE20/DRSP/L-5-MTHF Ca) / Metafolin\]. Bioequivalence is established if the 90% confidence interval fall within the equivalence interval limits of 80-125%|39 volunteers qualified for statistical analysis of BE whereas all 39 (EE20/DRSP/L-5-MTHF Ca) and 40 (Metafolin) volunteers with valid concentration time profiles were included in the pharmacokinetic (PK) analysis||109.34|91.24|
72515298|NCT01253187|144561271|NON_INFERIORITY_OR_EQUIVALENCE|A sample size of 6 volunteers per sequence was considered sufficient to establish bioequivalence, id est the 90%-confidence interval for the mean ratio is located completely within the equivalence interval limits of 80% and 125%.|mean ratio|98.16||||||90.0|93.95|102.57||The equivalence test was done using a 90% confidence interval, no p-value was to be calculated.|ANOVA||Point estimate for the ratio \[(EE20/DRSP/L-5-MTHF Ca) / Metafolin\]. Bioequivalence is established if the 90% confidence interval fall within the equivalence interval limits of 80-125%|39 volunteers qualified for statistical analysis of BE whereas all 39 (EE20/DRSP/L-5-MTHF Ca) and 40 (Metafolin) volunteers with valid concentration time profiles were included in the pharmacokinetic (PK) analysis||102.57|93.95|
72515299|NCT01253187|144561272|NON_INFERIORITY_OR_EQUIVALENCE|A sample size of 6 volunteers per sequence was considered sufficient to establish bioequivalence, id est the 90%-confidence interval for the mean ratio is located completely within the equivalence interval limits of 80% and 125%.|mean ratio|100.28||||||90.0|93.15|107.95||The equivalence test was done using a 90% confidence interval, no p-value was to be calculated.|ANOVA||Point estimate for the ratio \[(EE20/DRSP/L-5-MTHF Ca) / Metafolin\]. Bioequivalence is established if the 90% confidence interval fall within the equivalence interval limits of 80-125%|40 volunteers qualified for statistical analysis of BE and all 40 volunteers with valid concentration time profiles were included in the pharmacokinetic (PK) analysis||107.95|93.15|
72568257|NCT00359788|144668081|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.035||||0.0997||95.0|-0.076|0.007|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.007|-0.076|0.0997
72568258|NCT00359788|144668082|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.037||||0.101||95.0|-0.007|0.08|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.08|-0.007|0.101
72568259|NCT00359788|144668083|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.145|||<|0.0001||95.0|0.098|0.193|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.193|0.098|<0.0001
72568260|NCT00359788|144668084|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.055||||0.0411||95.0|-0.108|-0.002|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||-0.002|-0.108|0.0411
72568261|NCT00359788|144668085|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.06||||0.0354||95.0|-0.116|-0.004|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||-0.004|-0.116|0.0354
72568262|NCT00359788|144668086|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.062||||0.041||95.0|-0.121|-0.003|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||-0.003|-0.121|0.041
72403699|NCT02530450|144313317|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||Testing the change between two time points within each group using Wilcoxon signed rank test.||||< 0.05
72403700|NCT00896337|144313348|SUPERIORITY_OR_OTHER||9-month major adverse event rate|3.4|||<|0.0001|TWO_SIDED|95.0|0.9|8.5||A one-sided exact-test was used to test the hypothesis that the primary endpoint rate in the Epic-treated cohort is less than the predefined performance goal of 17.0%.|One-sided exact-test|||MAE rate was compared to a predefined performance goal of 17.0%, based on literature-derived expected rate of 8.0% for iliac stenting plus a 9.0% margin. Study had 87% statistical power to show the MAE rate (accounting for 9-month attrition of \<=15%) is less than the performance goal, assuming a 9-month MAE rate of 8.0%. If the exact one-sided 95% upper confidence bound of the observed rate is lower than the performance goal, the Epic stent would be considered to have acceptable performance.||8.5|0.9|<0.0001
72568263|NCT00359788|144668087|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.018||||0.5387||95.0|-0.076|0.04|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.04|-0.076|0.5387
72403701|NCT01883427|144313412|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||Not significant|Wilcoxon (Mann-Whitney)|||Too few included to reach power||||>0.05
72568264|NCT00359788|144668088|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.061||||0.0372||95.0|0.004|0.118|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.118|0.004|0.0372
72568265|NCT00359788|144668089|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.121|||<|0.0001||95.0|0.066|0.177|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.177|0.066|<0.0001
72568266|NCT00359788|144668090|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.162|||<|0.0001||95.0|0.108|0.216|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.216|0.108|<0.0001
72568267|NCT00359788|144668091|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.106|||<|0.0001||95.0|0.055|0.157|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.157|0.055|<0.0001
72568268|NCT00359788|144668092|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.083||||0.0023||95.0|-0.136|-0.03|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||-0.03|-0.136|0.0023
72403702|NCT01538862|144313444|SUPERIORITY|||||||0.82|||||||Regression, Linear|||||||0.82
72403703|NCT01400516|144313447|SUPERIORITY||Median Difference (Final Values)|9.5||||0.28|TWO_SIDED|||||A p-value \< 0.05 is considered statistically significant.|Linear mixed model||control-teriparatide|||||0.28
72488243|NCT01431274|144505142|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.064|STANDARD_ERROR_OF_MEAN|0.136||0.6382|TWO_SIDED|95.0|-0.202|0.33||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within-patient errors."|||0.330|-0.202|0.6382
72488244|NCT01431274|144505142|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.126|STANDARD_ERROR_OF_MEAN|0.135||0.3525|TWO_SIDED|95.0|-0.14|0.391||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (2.5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within-patient errors."|||0.391|-0.140|0.3525
72488245|NCT01431274|144505142|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.062|STANDARD_ERROR_OF_MEAN|0.135||0.6457|TWO_SIDED|95.0|-0.327|0.203||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.203|-0.327|0.6457
72568269|NCT00359788|144668093|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.087||||0.0019||95.0|-0.142|-0.033|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||-0.033|-0.142|0.0019
72488246|NCT01431274|144505143|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.033|STANDARD_ERROR_OF_MEAN|0.012||0.0067|TWO_SIDED|95.0|0.009|0.056||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within-patient errors."|||0.056|0.009|0.0067
72488247|NCT01431274|144505143|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.081|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|0.057|0.104||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Tiotropium (5 μg).~Spatial power covariance structure for within-patient errors."|||0.104|0.057|<0.0001
72488248|NCT01431274|144505143|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.022|STANDARD_ERROR_OF_MEAN|0.012||0.0746|TWO_SIDED|95.0|-0.002|0.045||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within-patient errors."|||0.045|-0.002|0.0746
72488249|NCT01431274|144505143|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.078|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|0.054|0.101||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.101|0.054|<0.0001
72488250|NCT01431274|144505143|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.07|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|0.046|0.093||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (5 µg).~Spatial power covariance structure for within-patient errors."|||0.093|0.046|<0.0001
72488251|NCT01431274|144505143|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.011|STANDARD_ERROR_OF_MEAN|0.012||0.3549|TWO_SIDED|95.0|-0.013|0.035||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tio+Olo FDC (2.5/5 µg).~Spatial power covariance structure for within-patient errors."|||0.035|-0.013|0.3549
72488252|NCT01431274|144505143|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.089|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|0.065|0.113||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.113|0.065|<0.0001
72568270|NCT00359788|144668094|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.083||||0.0044||95.0|-0.139|-0.026|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||-0.026|-0.139|0.0044
72515300|NCT01253187|144561273|NON_INFERIORITY_OR_EQUIVALENCE|A sample size of 6 volunteers per sequence was considered sufficient to establish bioequivalence, id est the 90%-confidence interval for the mean ratio is located completely within the equivalence interval limits of 80% and 125%.|mean ratio|99.88||||||90.0|95.38|104.58||The equivalence test was done using a 90% confidence interval, no p-value was to be calculated.|ANOVA||Point estimate for the ratio \[(EE20/DRSP/L-5-MTHF Ca) / Metafolin\]. Bioequivalence is established if the 90% confidence interval fall within the equivalence interval limits of 80-125%|40 volunteers qualified for statistical analysis of BE and all 40 volunteers with valid concentration time profiles were included in the pharmacokinetic (PK) analysis||104.58|95.38|
72568271|NCT00359788|144668095|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.046||||0.1182||95.0|-0.103|0.012|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.012|-0.103|0.1182
72577113|NCT02045147|144680859|OTHER||Mean Difference (Final Values)|1.8|STANDARD_ERROR_OF_MEAN|2.5||0.472|TWO_SIDED|95.0|-3.21|6.84|||t-test, 2 sided|||||6.84|-3.21|0.472
72515301|NCT01253187|144561275|NON_INFERIORITY_OR_EQUIVALENCE|A sample size of 6 volunteers per sequence was considered sufficient to establish bioequivalence, id est the 90%-confidence interval for the mean ratio is located completely within the equivalence interval limits of 80% and 125%.|mean ratio|100.3||||||90.0|97.65|103.02||The equivalence test was done using a 90% confidence interval, no p-value was to be calculated.|ANOVA||Point estimate for the ratio \[(EE20/DRSP/L-5-MTHF Ca) / YAZ\]. Bioequivalence is established if the 90% confidence interval fall within the equivalence interval limits of 80-125%|32 volunteers qualified for statistical analysis of BE whereas all 34 (YAZ) and 36 (EE20/DRSP/L-5-MTHF Ca) volunteers with valid concentration time profiles were included in the pharmacokinetic (PK) analysis||103.02|97.65|
72515302|NCT01956240|144561282|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.51|STANDARD_DEVIATION|1.9|<|0.05|TWO_SIDED|95.0|||||ANOVA|A 1-way repeated measures ANOVA was used to assess for possible differences among evaluations in each group separately for pectoralis minor length.||||||<0.05
72515303|NCT01956240|144561283|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|5.0|||>|0.05|TWO_SIDED|95.0|||||ANOVA|Separate 2-way repeated measures ANOVAs were used to test for interactions of angle x evaluation (1,2,3) and for main effects of evaluation.||||||>0.05
72515304|NCT00600028|144561287|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.0||||0.001|TWO_SIDED|95.0|||||Mixed Models Analysis||The values represents three months on each intervention|||||0.001
72515305|NCT00600028|144561288|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.0||||0.0001|TWO_SIDED|95.0|||||Mixed Models Analysis||The values represents three months on each intervention|||||.0001
72515306|NCT03172481|144561300|OTHER|The primary efficacy analysis used a mixed-model repeated measures (MMRM) analysis on the full day laboratory classroom SKAMP-C scores from each time point as the dependent variable. The repeated measures model adjusted means (LS-means) for PRC-063 and placebo were compared statistically using a t-test with an overall 5% significance level to evaluate efficacy. The LS-means estimate an overall treatment effect across the entire 13-hour classroom evaluation.|||||<|0.0001|||||||ANOVA|||||||<0.0001
72515307|NCT01709786|144561326|SUPERIORITY_OR_OTHER||Bland-Altman Analysis|1.49|||||TWO_SIDED|||||p-value is not reported since Bland-Altman is not a hypothesis testing framework.|Limits of agreement||Limits of agreement are -2.02 to 5.00. This is not a confidence interval because Bland-Altman is not a hypothesis testing framework.|||||
72515308|NCT01709786|144561327|SUPERIORITY_OR_OTHER||Limits of agreement|-0.63|||||TWO_SIDED|||||p-value not reported since Bland-Altman is not a hypothesis testing framework.|Bland-Altman Analysis||Limits of agreement are -3.44 to 2.18. This is not a confidence interval because Bland-Altman is not a hypothesis testing framework.|||||
72515309|NCT00664755|144561336|SUPERIORITY||Odds Ratio (OR)|2.77||||0.011|TWO_SIDED|95.0|1.17|6.59|||Regression, Logistic|||||6.59|1.17|0.011
72515310|NCT01840228|144561342|SUPERIORITY||Risk Ratio (RR)|1.1||||0.74|TWO_SIDED|95.0|0.63|1.91|||Chi-squared|||||1.91|0.63|0.74
72515311|NCT01840228|144561343|SUPERIORITY||Risk Ratio (RR)|0.43||||0.13|TWO_SIDED|95.0|0.14|1.36|||Fisher Exact|||||1.36|0.14|0.13
72515312|NCT01840228|144561344|SUPERIORITY||Risk Ratio (RR)|1.5||||0.71|TWO_SIDED|95.0|0.51|4.43|||Fisher Exact|||||4.43|0.51|0.71
72403704|NCT01412866|144313450|SUPERIORITY_OR_OTHER|||||||0.08|||||||Chi-squared|df=1||||||0.08
72515313|NCT01840228|144561345|SUPERIORITY|||||||0.73|||||||Wilcoxon (Mann-Whitney)|||||||0.73
72515314|NCT01295580|144561373|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|"This is a non-inferiority test. The non-inferiority margin of +1.6 units corresponds to an 8% margin on the pain subscale (range 0-20)~Alpha inflation was controlled using pre-planned stepwise hypotheses testing (1) WOMAC Pain over 18 weeks then (2) over 26 weeks, (3) WOMAC Physical Function over 18 weeks then (4) over 26 weeks, (5) Subject Global Assessment over 18 weeks then (6) over 26 weeks, (7) WOMAC Knee Stiffness over 18 weeks then (8) over 26 weeks."|Mean Difference (Final Values)|-0.09|||||TWO_SIDED|95.0|-0.58|0.39||Alpha inflation due to multiple testing was controlled using preplanned ordered stepwise hypothesis testing first over 18 weeks then over 26 weeks. This section reports the first step WOMAC pain over 18 week pain subscale primary analyses.||The second step is to test Durolane WOMAC pain non-inferior to Artz WOMAC pain over 26 weeks.||"Primary Hypothesis:~Ho: μDUR\[18\] - μArtz\[18\] ≥ +1.6 units Ha: μDUR\[18\] - μArtz\[18\] \< +1.6 units~Power Calculations:~Assume the over 18 weeks difference is 0mm, SD 20mm (5 on the Likert scale), 90% power, 2-sided test alpha 5%, and a 8mm non-inferiority margin (1.6 on the Likert scale), the sample size required is 132 subjects per group adjusted to 175 to hold power constant due to loss to follow-up and dropout."||0.39|-0.58|
72515315|NCT01295580|144561374|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|This is a non-inferiority test. The non-inferiority margin of +1.6 units corresponds to an 8% margin on the pain subscale (range 0-20)|Mean Difference (Final Values)|-0.1|||||TWO_SIDED|95.0|-0.56|0.37||Alpha inflation due to multiple testing was controlled using preplanned ordered stepwise hypothesis testing first pain over 18 weeks then pain over 26 weeks. This section reports the over 26 week pain subscale results.||The third ordered test is Durolane WOMAC physical function subscale non-inferior to Artz WOMAC physical function subscale over 18 weeks.||Ho: μDUR\[26\] - μArtz\[26\] ≥ +1.6 units Ha: μDUR\[26\] - μArtz\[26\] \< +1.6 units||0.37|-0.56|
72515316|NCT01295580|144561375|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|This is a non-inferiority test. The non-inferiority margin of +5.44 units corresponds to an 8% margin on the physical function subscale (range 0-68).|Mean Difference (Final Values)|-0.65|||||TWO_SIDED|95.0|-1.81|0.51||Alpha inflation due to multiple testing was controlled using preplanned ordered stepwise hypothesis testing first over 18 weeks then over 26 weeks. This section reports the over 18 week physical function results.||The fourth step is to test Durolane WOMAC physical function non-inferior to Artz physical function over 26 weeks.||Ho: μDUR\[18\] - μArtz\[18\] ≥ +5.44 units Ha: μDUR\[18\] - μArtz\[18\] \< +5.44 units||0.51|-1.81|
72568272|NCT00359788|144668096|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.02||||0.4814||95.0|-0.037|0.078||ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.|ANCOVA|||||0.078|-0.037|0.4814
72568273|NCT00359788|144668097|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.074||||0.008||95.0|0.019|0.129|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.129|0.019|0.008
72568274|NCT00359788|144668098|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.136|||<|0.0001||95.0|0.082|0.19|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.19|0.082|<0.0001
72568275|NCT00359788|144668099|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.37|||<|0.0001||95.0|-0.449|-0.29|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||-0.29|-0.449|<0.0001
72568276|NCT00359788|144668100|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.356|||<|0.0001||95.0|-0.44|-0.272|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||-0.272|-0.44|<0.0001
72568277|NCT00359788|144668101|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.357|||<|0.0001||95.0|-0.451|-0.264|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||-0.264|-0.451|<0.0001
72568278|NCT00359788|144668102|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.285|||<|0.0001||95.0|-0.376|-0.194|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||-0.194|-0.376|<0.0001
72568279|NCT00359788|144668103|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.17||||0.0003||95.0|-0.261|-0.079|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||-0.079|-0.261|0.0003
72568280|NCT00359788|144668104|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.05||||0.2992||95.0|-0.143|0.044|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.044|-0.143|0.2992
72568281|NCT00359788|144668105|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.081||||0.0984||95.0|-0.015|0.177|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.177|-0.015|0.0984
72568282|NCT00359788|144668106|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.278|||<|0.0001||95.0|0.178|0.379|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.379|0.178|<0.0001
72568283|NCT00359788|144668107|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.189||||0.0004||95.0|-0.293|-0.086|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||-0.086|-0.293|0.0004
72568284|NCT00359788|144668108|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.204||||0.0003||95.0|-0.314|-0.095|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||-0.095|-0.314|0.0003
72568285|NCT00359788|144668109|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1832||||0.012||95.0|-0.293|-0.072|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||-0.072|-0.293|0.012
72568286|NCT00359788|144668110|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.097||||0.044||95.0|-0.219|0.003|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.003|-0.219|0.044
72568287|NCT00359788|144668111|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.05||||0.3634||95.0|-0.058|0.158|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.158|-0.058|0.3634
72568288|NCT00359788|144668112|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.163||||0.0032||95.0|0.055|0.27|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.27|0.055|0.0032
72568289|NCT00359788|144668113|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.275|||<|0.0001||95.0|0.173|0.378|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.378|0.173|<0.0001
72568290|NCT00359788|144668114|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.175||||0.0015||95.0|0.067|0.283|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.283|0.067|0.0015
72568291|NCT00359788|144668115|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.193||||0.0002||95.0|-0.296|-0.091|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||-0.091|-0.296|0.0002
72568292|NCT00359788|144668116|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.215|||<|0.0001||95.0|-0.323|-0.108|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||-0.108|-0.323|<0.0001
72568293|NCT00359788|144668117|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.198||||0.0006||95.0|-0.309|-0.086|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||-0.086|-0.309|0.0006
72568294|NCT00359788|144668118|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.097||||0.0896||95.0|-0.21|0.015|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.015|-0.21|0.0896
72568295|NCT00359788|144668119|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.008||||0.8937||95.0|-0.103|0.118|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.118|-0.103|0.8937
72568296|NCT00359788|144668120|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.125||||0.0269||95.0|0.014|0.236|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.236|0.014|0.0269
72568297|NCT00359788|144668121|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.223||||0.0001||95.0|0.111|0.335|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.335|0.111|0.0001
72568298|NCT00359788|144668122|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.042||||0.7196||95.0|-0.275|0.19|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.19|-0.275|0.7196
72568299|NCT00359788|144668123|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.069||||0.6189||95.0|-0.343|0.205|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.205|-0.343|0.6189
72568300|NCT00359788|144668124|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.073||||0.6197||95.0|-0.36|0.215|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.215|-0.36|0.6197
72568301|NCT00359788|144668125|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.112||||0.4582||95.0|-0.408|0.184|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.184|-0.408|0.4582
72568302|NCT00359788|144668126|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.07||||0.6538||95.0|-0.376|0.236|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.236|-0.376|0.6538
72568303|NCT00359788|144668127|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.145||||0.4145||95.0|-0.495|0.205|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.205|-0.495|0.4145
72403705|NCT01796197|144313484|SUPERIORITY||Pathelogic Complete Response Rate|40.0|||||TWO_SIDED||||||Two stage design, exact method||Decision Rule: If the percentage of participants experiencing pathologic complete response (pCR) is ≤ 15% then the preoperative regimen is considered minimally effective. If the proportion of pCR ≥ 40% then the regimen is worthy of further study.|Null Hypothesis: pCR rate is less than or equal to 15% Alternative Hypothesis: pCR rate is greater than or equal to 40% Hypothesized False Positive Rate (alpha) : 3.9% Hypothesized False Negative Rate (1-beta) : 9.9%||||
72488253|NCT01431274|144505143|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.048|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|-0.072|-0.025||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within-patient errors."|||-0.025|-0.072|<0.0001
72488254|NCT01431274|144505143|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.056|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|-0.08|-0.033||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (2.5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within-patient errors."|||-0.033|-0.080|<0.0001
72488255|NCT01431274|144505143|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.008|STANDARD_ERROR_OF_MEAN|0.012||0.5018|TWO_SIDED|95.0|-0.016|0.032||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.032|-0.016|0.5018
72488256|NCT01431274|144505144|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.128|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|0.104|0.152||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within-patient errors."|||0.152|0.104|<0.0001
72488257|NCT01431274|144505144|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.126|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|0.102|0.15||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Tiotropium (5 μg).~Spatial power covariance structure for within-patient errors."|||0.150|0.102|<0.0001
72488258|NCT01431274|144505144|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.111|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|0.087|0.135||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within-patient errors."|||0.135|0.087|<0.0001
72488259|NCT01431274|144505144|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.096|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|0.072|0.12||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.120|0.072|<0.0001
72488260|NCT01431274|144505144|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.109|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|0.085|0.133||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (5 µg).~Spatial power covariance structure for within-patient errors."|||0.133|0.085|<0.0001
72488261|NCT01431274|144505144|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.017|STANDARD_ERROR_OF_MEAN|0.012||0.1569|TWO_SIDED|95.0|-0.007|0.041||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tio+Olo FDC (2.5/5 µg).~Spatial power covariance structure for within-patient errors."|||0.041|-0.007|0.1569
72488262|NCT01431274|144505144|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.113|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|0.089|0.137||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.137|0.089|<0.0001
72568304|NCT00359788|144668128|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.085||||0.6048||95.0|-0.408|0.238|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.238|-0.408|0.6048
72577114|NCT02045147|144680860|OTHER||Mean Difference (Final Values)|-2.0|STANDARD_ERROR_OF_MEAN|3.15||0.532|TWO_SIDED|95.0|-8.5|4.5|||t-test, 2 sided|||||4.5|-8.5|0.532
72568305|NCT00359788|144668129|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.17||||0.3137||95.0|-0.503|0.162|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.162|-0.503|0.3137
72568306|NCT00359788|144668130|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.061||||0.7195||95.0|-0.395|0.273|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.273|-0.395|0.7195
72568307|NCT00359788|144668131|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.043||||0.7947||95.0|-0.367|0.282|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.282|-0.367|0.7947
72568308|NCT00359788|144668132|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.093||||0.6049||95.0|-0.446|0.26|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.26|-0.446|0.6049
72568309|NCT00359788|144668133|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.047||||0.8109||95.0|-0.437|0.342|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.342|-0.437|0.8109
72568310|NCT00359788|144668134|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.527||||0.1471||95.0|-0.186|1.24|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||1.24|-0.186|0.1471
72568311|NCT00359788|144668135|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.265||||0.3192||95.0|-0.258|0.788|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.788|-0.258|0.3192
72568312|NCT00359788|144668136|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.351||||0.182||95.0|-0.165|0.867|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.867|-0.165|0.182
72568313|NCT00359788|144668137|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.363||||0.1777||95.0|-0.166|0.893|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.893|-0.166|0.1777
72568314|NCT00359788|144668138|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.363||||0.1805||95.0|-0.169|0.895|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.895|-0.169|0.1805
72568315|NCT00359788|144668139|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.372||||0.1777||95.0|-0.17|0.913|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.913|-0.17|0.1777
72568316|NCT00359788|144668140|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.159||||0.5725||95.0|-0.395|0.714|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.714|-0.395|0.5725
72568317|NCT00359788|144668141|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.121||||0.6765||95.0|-0.449|0.69|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.69|-0.449|0.6765
72568318|NCT00359788|144668142|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.247||||0.3943||95.0|-0.323|0.818|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.818|-0.323|0.3943
72568319|NCT00359788|144668143|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.291||||0.3091||95.0|-0.271|0.852|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.852|-0.271|0.3091
72568320|NCT00359788|144668144|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.317||||0.2911||95.0|-0.273|0.907|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.907|-0.273|0.2911
72568321|NCT00359788|144668145|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.108||||0.7458||95.0|-0.549|0.766|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.766|-0.549|0.7458
72568322|NCT00359788|144668146|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.698||||0.0004||95.0|4.836|16.56|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||16.56|4.836|0.0004
72568323|NCT00359788|144668147|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.257||||0.0023||95.0|4.055|18.458|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||18.458|4.055|0.0023
72568324|NCT00359788|144668148|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.772||||0.0015||95.0|4.942|20.602|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||20.602|4.942|0.0015
72568325|NCT00359788|144668149|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.568||||0.0013||95.0|5.342|21.795|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||21.795|5.342|0.0013
72568326|NCT00359788|144668150|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.052||||0.005||95.0|3.676|20.428|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||20.428|3.676|0.005
72568327|NCT00359788|144668151|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.107||||0.0159||95.0|2.095|20.119|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||20.119|2.095|0.0159
72568328|NCT00359788|144668152|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.057||||0.0219||95.0|1.613|20.501|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||20.501|1.613|0.0219
72568329|NCT00359788|144668153|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.655||||0.0048||95.0|4.207|23.104|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||23.104|4.207|0.0048
72568330|NCT00359788|144668154|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.231||||0.0058||95.0|4.153|24.31|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||24.31|4.153|0.0058
72568331|NCT00359788|144668155|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.597||||0.0248||95.0|1.483|21.71|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||21.71|1.483|0.0248
72568332|NCT00359788|144668156|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.001||||0.0325||95.0|0.924|21.079|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||21.079|0.924|0.0325
72568333|NCT00359788|144668157|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.074||||0.0153||95.0|2.726|25.422|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||25.422|2.726|0.0153
72568334|NCT00359788|144668158|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.755||||0.6105||95.0|-8.532|5.022|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||5.022|-8.532|0.6105
72568335|NCT00359788|144668159|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.842||||0.8249||95.0|-6.642|8.326|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||8.326|-6.642|0.8249
72568336|NCT00359788|144668160|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.71||||0.4896||95.0|-5.001|10.421|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||10.421|-5.001|0.4896
72568337|NCT00359788|144668161|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.898||||0.0935||95.0|-1.172|14.968|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||14.968|-1.172|0.0935
72488263|NCT01431274|144505144|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.002|STANDARD_ERROR_OF_MEAN|0.012||0.8834|TWO_SIDED|95.0|-0.022|0.026||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within-patient errors."|||0.026|-0.022|0.8834
72515317|NCT01295580|144561376|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|This is a non-inferiority test. The non-inferiority margin of +5.44 units corresponds to an 8% margin on the physical function subscale (range 0-68).|Mean Difference (Final Values)|-0.58|||||TWO_SIDED|95.0|-1.69|0.53||Alpha inflation due to multiple testing was controlled using preplanned ordered stepwise hypothesis testing first over 18 weeks then over 26 weeks. This section reports the over 26 week physical function subscale results.||The fifth step is to test Durolane subject global assessment non-inferior to Artz global assessment over 18 weeks.||Ho: μDUR\[26\] - μArtz\[26\] ≥ +5.44 units Ha: μDUR\[26\] - μArtz\[26\] \< +5.44 units||0.53|-1.69|
72515318|NCT01295580|144561377|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|This is a non-inferiority test. The non-inferiority margin of -0.8 units corresponds to an 8% margin on the subject global assessment (range 0-10). Note that because the assessment interpretation is reversed as compared to the WOMAC assessments the lower bound of the 95%CI is compared to the -0.8 non-inferiority margin.|Mean Difference (Final Values)|0.15|||||TWO_SIDED|95.0|-0.15|0.45||Alpha inflation due to multiple testing was controlled using preplanned ordered stepwise hypothesis testing first over 18 weeks then over 26 weeks. This section reports the over 18 week subject global assessment results.||The sixth step is to test Durolane subject global assessment non-inferior to Artz subject global assessment over 26 weeks.||Ho: μDUR\[18\] - μArtz\[18\] ≤ -0.8 units Ha: μDUR\[18\] - μArtz\[18\] \> -0.8 units||0.45|-0.15|
72568338|NCT00359788|144668162|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.419||||0.4339||95.0|-5.17|12.007|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||12.007|-5.17|0.4339
72568339|NCT00359788|144668163|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.971||||0.845||95.0|-10.74|8.799|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||8.799|-10.74|0.845
72488264|NCT01431274|144505144|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.015|STANDARD_ERROR_OF_MEAN|0.012||0.2129|TWO_SIDED|95.0|-0.009|0.039||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (2.5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within-patient errors."|||0.039|-0.009|0.2129
72488265|NCT01431274|144505144|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.013|STANDARD_ERROR_OF_MEAN|0.012||0.2702|TWO_SIDED|95.0|-0.037|0.01||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.010|-0.037|0.2702
72488266|NCT01431274|144505145|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.141|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|0.117|0.166||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within-patient errors."|||0.166|0.117|<0.0001
72568340|NCT00359788|144668164|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.194||||0.9696||95.0|-9.811|10.199|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||10.199|-9.811|0.9696
72568341|NCT00359788|144668165|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.129||||0.3252||95.0|-5.117|15.376|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||15.376|-5.117|0.3252
72568342|NCT00359788|144668166|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.062||||0.452||95.0|-6.558|14.683|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||14.683|-6.558|0.452
72568343|NCT00359788|144668167|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.14||||0.4388||95.0|-6.372|14.651|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||14.651|-6.372|0.4388
72568344|NCT00359788|144668168|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.185||||0.8288||95.0|-9.595|11.964|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||11.964|-9.595|0.8288
72568345|NCT00359788|144668169|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.204||||0.4929||95.0|-7.857|16.264|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||16.264|-7.857|0.4929
72577115|NCT02045147|144680860|OTHER||Mean Difference (Final Values)|-1.7|STANDARD_ERROR_OF_MEAN|2.9||0.574|TWO_SIDED|95.0|-7.5|4.2|||t-test, 2 sided|||||4.2|-7.5|0.574
72515319|NCT01295580|144561378|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|This is a non-inferiority test. The non-inferiority margin of -0.8 units corresponds to an 8% margin on the subject global assessment (range 0-10). Note that because the assessment interpretation is reversed as compared to the WOMAC assessments the lower bound of the 95%CI is compared to the -0.8 non-inferiority margin.|Mean Difference (Final Values)|0.14|||||TWO_SIDED|95.0|-0.16|0.43||Alpha inflation due to multiple testing was controlled using preplanned ordered stepwise hypothesis testing first over 18 weeks then over 26 weeks. This section reports the over 26 week subject global assessment results.||The seventh step is to test Durolane WOMAC knee stiffness non-inferior to Artz WOMAC knee stiffness over 18 weeks.||Ho: μDUR\[18\] - μArtz\[18\] ≤ -0.8 units Ha: μDUR\[18\] - μArtz\[18\] \> -0.8 units||0.43|-0.16|
72515320|NCT01295580|144561379|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|This is a non-inferiority test. The non-inferiority margin of +0.64 units corresponds to an 8% margin on the knee stiffness subscale (range 0-8).|Mean Difference (Final Values)|-0.14|||||TWO_SIDED|95.0|-0.33|0.05||Alpha inflation due to multiple testing was controlled using preplanned ordered stepwise hypothesis testing first over 18 weeks then over 26 weeks. This section reports the over 18 week knee stiffness subscale results.||The eight and last step is to test Durolane WOMAC knee stiffness non-inferior to Artz WOMAC knee stiffness over 26 weeks.||Ho: μDUR\[18\] - μArtz\[18\] ≥ +0.64 units Ha: μDUR\[18\] - μArtz\[18\] \< +0.64 units||0.05|-0.33|
72515321|NCT01295580|144561380|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|This is a non-inferiority test. The non-inferiority margin of 0.64 units corresponds to an 8% margin on the knee stiffness subscale (range 0-8).|Mean Difference (Final Values)|-0.15|||||TWO_SIDED|95.0|-0.33|0.03||Alpha inflation due to multiple testing was controlled using preplanned ordered stepwise hypothesis testing first over 18 weeks then over 26 weeks. This section reports the over 26 week knee stiffness subscale results.||This is the eighth and last pre-planned hypothesis test.||Ho: μDUR\[26\] - μArtz\[26\] ≥ +0.64 units Ha: μDUR\[26\] - μArtz\[26\] \< +0.64 units||0.03|-0.33|
72515322|NCT01148563|144561389|SUPERIORITY||Risk Ratio, log|-0.3|STANDARD_ERROR_OF_MEAN|0.18||0.094|TWO_SIDED|95.0|-0.65|0.05|||bootstrapping||The hypothesis test was based on ln(relative risk), with the tele-monitoring group value as the relative risk numerator and the control group value as the denominator. The standard error was generated by bootstrapping the sample.|||0.05|-0.65|0.094
72515323|NCT01148563|144561390|SUPERIORITY||Risk Ratio, log|0.7|STANDARD_ERROR_OF_MEAN|0.22||0.105|TWO_SIDED|95.0|0.45|1.08|||bootstrapping|The standard error was generated by bootstrapping the sample.|The hypothesis test was based on ln(relative risk) with the tele-monitoring group value as the numerator and the control group as the denominator.|||1.08|0.45|0.105
72515324|NCT01879319|144561391|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|-2.4|||||TWO_SIDED|95.0|-11.2|6.1||||||||6.1|-11.2|
72515325|NCT01879319|144561392|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|3.4|STANDARD_ERROR_OF_MEAN|3.2|||TWO_SIDED|95.0|-2.9|9.7||||||||9.7|-2.9|
72515326|NCT04724733|144561402|SUPERIORITY||||||>|0.05|||||||t-test, 1 sided|||||||>0.05
72515327|NCT04724733|144561402|SUPERIORITY||||||>|0.05|||||||t-test, 1 sided|||||||>0.05
72515328|NCT04724733|144561402|SUPERIORITY|||||||0.0172|||||||t-test, 1 sided|||||||0.0172
72403706|NCT00502697|144313519|SUPERIORITY_OR_OTHER|||||||0.64|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||The original proposed sample size for this study was 300. This sample size was based on previous evidence that indicated that a reduction of 15% in the rate of preterm birth would be detectable with groups of 150. Because of concerns with systemic changes in the study's health care delivery environment, an interim analysis was conducted after 200 women had delivered. As a result of that analysis a decision was made to stop recruitment.||||.64
72515329|NCT04724733|144561403|SUPERIORITY|||||||0.032|||||||t-test, 1 sided|||||||.0320
72515330|NCT04724733|144561403|SUPERIORITY||||||>|0.05|||||||t-test, 1 sided|||||||>0.05
72515331|NCT04724733|144561403|SUPERIORITY|||||||0.0008|||||||t-test, 1 sided|||||||0.0008
72403707|NCT00589108|144313549|SUPERIORITY_OR_OTHER|||||||0.64||95.0|||||ANOVA|||P-value for the difference between the mean maximum flexion between the three groups at 2 years post-surgery.||||0.64
72515332|NCT04511819|144561412|OTHER||Risk Difference (RD)|-0.087||||0.8762|TWO_SIDED|95.0|-0.347|0.174|||Regression, Logistic|||||0.174|-0.347|0.8762
72515333|NCT00844649|144561471|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.72|||<|0.0001|TWO_SIDED|95.0|0.617|0.835||P-value was based on a stratified log-rank test stratified by randomization strata of geographic region (North America versus Others), Karnofsky performance score (70 to 80 versus 90 to 100), and presence of liver metastasis|Stratified Log-rank Test||Hazard ratio of Albumin bound paclitaxel + gemcitabine/gemcitabine alone. The associated hazard ratio and two-sided 95% confidence interval were estimated using a stratified Cox proportional hazard model.|||0.835|0.617|<0.0001
72515334|NCT00844649|144561472|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.69|||<|0.0001|TWO_SIDED|95.0|0.581|0.821||P-value was based on a stratified log-rank test by randomization strata of geographic region (North America versus Others), Karnofsky performance score (70 to 80 versus 90 to 100), and presence of liver metastasis (yes vs no)|Stratified Log-rank Test||Hazard ratio of Albumin bound paclitaxel + gemcitabine / gemcitabine alone. The associated hazard ratio and two-sided 95% confidence interval were estimated using a stratified Cox proportional hazard model.|||0.821|0.581|<0.0001
72515335|NCT00844649|144561473|SUPERIORITY_OR_OTHER_LEGACY||Response Rate Ratio|3.19|||<|0.0001|TWO_SIDED|95.0|2.178|4.662|||Chi-squared||Response rate ratio: albumin-bound paclitaxel + gemcitabine /gemcitabine alone|PA+G/PG = response rate ratio of albumin bound paclitaxel + gemcitabine / gemcitabine.||4.662|2.178|<0.0001
72515336|NCT02767856|144561478|EQUIVALENCE|The study did not enroll enough samples. The stats here are only for reference.|Mean Difference (Net)|0.04||||0.48|TWO_SIDED|95.0|-0.08|0.16|||t-test, 2 sided|||Baseline and primary visit outcome||0.16|-0.08|0.48
72515337|NCT02767856|144561479|EQUIVALENCE|The study did not reach the target sample size. the stats are for reference.|Mean Difference (Final Values)|0.12||||0.26|TWO_SIDED|95.0|-0.75|0.99|||t-test, 2 sided|||||0.99|-0.75|0.26
72515338|NCT02767856|144561480|EQUIVALENCE|The study did not reach the target sample size. The stats are for reference.|Mean Difference (Final Values)|26.3||||0.26|TWO_SIDED|95.0|-21.75|74.2|||t-test, 2 sided|||||74.20|-21.75|0.26
72403708|NCT00589108|144313549|SUPERIORITY_OR_OTHER|||||||0.8||95.0|||||ANOVA|||P-value for the difference between the mean maximum flexion between the three groups at 5 years post-surgery.||||0.80
72403709|NCT00589108|144313550|SUPERIORITY_OR_OTHER|||||||0.06||95.0|||||ANOVA|||P-value for the difference for the Knee Society Function Score between the three groups at 5 years post-surgery.||||0.06
72403710|NCT00589108|144313551|SUPERIORITY_OR_OTHER|||||||0.87||95.0|||||ANOVA|||P-value for the difference for the Knee Society Pain Score between the three groups at 5 years post-surgery.||||0.87
72403711|NCT00589108|144313552|SUPERIORITY_OR_OTHER|||||||0.44||95.0|||||ANOVA|||P-value for the difference between the Knee Society Stair Climbing Score between the three groups at 2 years post-surgery.||||0.44
72403712|NCT00589108|144313552|SUPERIORITY_OR_OTHER|||||||0.08||95.0|||||ANOVA|||P-value for the difference between the Knee Society Stair Climbing Score between the three groups at 5 years post-surgery.||||0.08
72403713|NCT00589108|144313553|SUPERIORITY_OR_OTHER|||||||0.92||95.0|||||ANOVA|||P-value for the difference between the percentage of knees surviving between the three groups at 5 years post-surgery.||||0.92
72515339|NCT02767856|144561481|EQUIVALENCE|The study did not reach the target sample size. The stats are for reference.|Mean Difference (Final Values)|11.1||||0.44|TWO_SIDED|95.0|-41.3|19.3|||t-test, 2 sided|||||19.3|-41.3|0.44
72515340|NCT00091026|144561491|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.0||||0.22|TWO_SIDED|95.0|-13.0|14.0|||Chi-squared|||||14|-13|0.22
72515341|NCT00091026|144561492|SUPERIORITY_OR_OTHER|||||||0.95||95.0|||||Log Rank|||||||0.95
72403714|NCT01713868|144313554|SUPERIORITY|GEE logistic regression accounted for within-hospital clustering, individual-level \& hospital-level covariates. We converted aORs to aRDs (95% CI) using the BF/BF group as the control group prevalence and reported separate effects of the 2 interventions. We fit multiplicative interaction models with indicator variables for education, mHealth, and their interaction. As the interaction between interventions was significant, we presented results from the interaction model.||||||0.03||||||Adjusted education effect p=0.34. Adjusted mHealth effect p\<0.001. Test for interaction p=0.01. Adjusted education only effect p=0.74. Adjusted mHealth only effect p=0.02. Adjusted mHealth and education effect: p=0.03|Regression, Logistic|||Sample size provided power of detecting the effect of an individual intervention in the presence of interaction.We assumed pre-study prevalence of a safe sleep practice ranging from 50% to 60% across hospitals. We powered the study to detect a 10 percentage point difference between two study groups, and determined that an analysis sample of n=1280 (320 per treatment group) was needed for 80% power (testing at two-sided p\<0.05). Allowing for 20% loss to follow-up, this led to a sample of n=1600.||||0.03
72403715|NCT01713868|144313555|SUPERIORITY|GEE logistic regression accounted for within-hospital clustering, individual-level \& hospital-level covariates. We converted aORs to aRDs (95% CI) using the BF/BF group as the control group prevalence and reported separate effects of the 2 interventions. We fit multiplicative interaction models with indicator variables for education, mHealth, and their interaction. As the interaction between interventions was not significant, we only presented main effects model.|||||<|0.001||||||Adjusted education effect: p=0.22. Adjusted mHealth effect p\<0.001. Test for interaction p=0.08.|Regression, Logistic|||Sample size provided power of detecting the effect of an individual intervention in the presence of interaction. We assumed pre-study prevalence of a safe sleep practice ranging from 50% to 60% across hospitals. We powered the study to detect a 10 percentage point difference between two study groups, and determined that an analysis sample of n=1280 (320 per treatment group) was needed for 80% power (testing at two-sided p\<0.05). Allowing for 20% loss to follow-up,this led to a sample of n=1600.||||<0.001
72515342|NCT00091026|144561493|SUPERIORITY_OR_OTHER|||||||0.86||95.0|||||Log Rank|||||||0.86
72515343|NCT00589979|144561494|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.78||||0.1006||95.0|0.89|3.55||All statistical tests were 2-sided with a significance level of alpha=0.05.|Cox frailty model|Model included treatment, sequence, period, and first-order carryover as fixed effects and frailty; patient nested within sequence was frailty.|The Hazard Ratio (HR) provided is the ratio of Placebo to Lidoderm.|The two treatments were compared by time-varying relative hazards, associated P values, and 95% confidence intervals. Appropriate survival or hazard functions were calculated.||3.55|0.89|0.1006
72515344|NCT00589979|144561496|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.86||||0.1272||95.0|0.86|4.02||The logistic regression model for repeated measures used for this analysis included treatment, sequence, period, and first-order carry-over as fixed effects and repeated measures taken on patients nested within sequence.|Regression, Logistic|The results presented are reported in terms of odds ratios, corresponding 95% confidence intervals, and P-values for each fixed effect in the model.|The Odds Ratio (OR) provided is the ratio of Lidoderm to Placebo.|The proportion of patients who exited from the current treatment period prior to the 4-week planned duration was analyzed using a logistic regression model for repeated measures.||4.02|0.86|0.1272
72515345|NCT00589979|144561497|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.54||||0.0224||95.0|-1.01|-0.08||All statistical tests were 2-sided with a significance level of alpha=0.05.|Linear mixed effects model||The results are reported as least squares means and their differences along with associated P-values, and 95% confidence intervals for each fixed effect in the model.|The overall treatment difference for the lidocaine patch 5% and placebo patch was compared by combining data for patients receiving the respective treatment regardless of the randomized study sequence. The endpoint was analyzed by linear mixed effects models incorporating treatment, period, sequence, and first-order carryover as fixed effects, and patient nested within sequence as a random effect. P-value for the random effect (s2) is from the Wald Z-test for the covariance parameter estimates.||-0.08|-1.01|0.0224
72568346|NCT00359788|144668170|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.204||||0.0754||95.0|-0.021|0.429|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.429|-0.021|0.0754
72568347|NCT00359788|144668171|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.251||||0.0765||95.0|-0.027|0.528|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.528|-0.027|0.0765
72403716|NCT01713868|144313556|SUPERIORITY|GEE logistic regression accounted for within-hospital clustering, individual-level \& hospital-level covariates. We converted aORs to aRDs (95% CI) using the BF/BF group as the control group prevalence and reported separate effects of the 2 interventions. We fit multiplicative interaction models with indicator variables for education, mHealth, and their interaction. As the interaction between interventions was not significant, we only presented main effects model.|||||<|0.001||||||Adjusted education effect p=0.07. Adjusted mHealth effect p\<0.001. Test for interaction p=0.54|Regression, Logistic|||Sample size provided power of detecting the effect of an individual intervention in the presence of interaction. We assumed pre-study prevalence of a safe sleep practice ranging from 50% to 60% across hospitals. We powered the study to detect a 10 percentage point difference between two study groups, and determined that an analysis sample of n=1280 (320 per treatment group) was needed for 80% power (testing at two-sided p\<0.05). Allowing for 20% loss to follow-up, this led to a sample of n=1600.||||<0.001
72403717|NCT01713868|144313557|SUPERIORITY|GEE logistic regression accounted for within-hospital clustering, individual-level \& hospital-level covariates. We converted aORs to aRDs (95% CI) using the BF/BF group as the control group prevalence and reported separate effects of the 2 interventions. We fit multiplicative interaction models with indicator variables for education, mHealth, and their interaction. As the interaction between interventions was not significant, we only presented main effects model.|||||<|0.001||||||Adjusted education effect p=0.33. Adjusted mHealth effect p\<0.001. Test for interaction p=0.29.|Regression, Logistic|||Sample size provided power of detecting the effect of an individual intervention in the presence of interaction. We assumed pre-study prevalence of a safe sleep practice ranging from 50% to 60% across hospitals. We powered the study to detect a 10 percentage point difference between two study groups, and determined that an analysis sample of n=1280 (320 per treatment group) was needed for 80% power (testing at two-sided p\<0.05). Allowing for 20% loss to follow-up, this led to a sample of n=1600.||||<0.001
72403718|NCT01713868|144313558|OTHER|Causal mediation analysis|Difference in proportions|0.16|||||TWO_SIDED|95.0|||||||||We performed causal mediation analyses to estimate the Total Effect of intervention on a categorical outcome as the difference in the proportion with the outcome for those who received the intervention and were positive on the mediator vs. those who received the control and were negative on the mediator. Significance is determined through 95% confidence intervals (CIs), with CIs not including 0.0 indicating significant effects.|||
72403719|NCT01713868|144313559|OTHER|Causal mediation analysis|Difference in proportions|0.14|||||TWO_SIDED|95.0|||||||||We performed causal mediation analyses to estimate the Total Effect of intervention on a categorical outcome as the difference in the proportion with the outcome for those who received the intervention and were positive on the mediator vs. those who received the control and were negative on the mediator. Significance is determined through 95% confidence intervals (CIs), with CIs not including 0.0 indicating significant effects.|||
72515346|NCT00589979|144561498|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.39||||0.2747||95.0|-0.31|1.09||All statistical tests were 2-sided with a significance level of alpha=0.05.|Linear mixed effects regression||The results are reported as least squares means and their differences along with associated P-values, and 95% confidence intervals for each fixed effect in the model.|The overall treatment difference for the lidocaine patch 5% and placebo patch was compared by combining data for patients receiving the respective treatment regardless of the randomized study sequence. The endpoint was analyzed by linear mixed effects models incorporating treatment, period, sequence, and first-order carryover as fixed effects, and patient nested within sequence as a random effect. P-value for the random effect (s2) is from the Wald Z-test for the covariance parameter estimates.||1.09|-0.31|0.2747
72515347|NCT00589979|144561499|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.22||||0.4498||95.0|-0.8|0.36||All statistical tests were 2-sided with a significance level of alpha=0.05.|Linear mixed effects model||The results are reported as least squares means and their differences along with associated P-values, and 95% confidence intervals for each fixed effect in the model.|Intense: the difference between Lidoderm and placebo was compared by combining data for patients receiving the respective treatment regardless of the randomized study sequence. The endpoint was analyzed by linear mixed effects models incorporating treatment, period, sequence, and first-order carryover as fixed effects, and patient nested within sequence as a random effect. P-value for the random effect (s2) is from the Wald Z-test for the covariance parameter estimates.||0.36|-0.80|0.4498
72515348|NCT00589979|144561499|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.5||||0.1065||95.0|-1.11|0.11||All statistical tests were 2-sided with a significance level of alpha=0.05.|Linear mixed effect models||The results are reported as least squares means and their differences along with associated P-values, and 95% confidence intervals for each fixed effect in the model.|Sharp: the difference between Lidoderm and placebo was compared by combining data for patients receiving the respective treatment regardless of the randomized study sequence. The endpoint was analyzed by linear mixed effects models incorporating treatment, period, sequence, and first-order carryover as fixed effects, and patient nested within sequence as a random effect. P-value for the random effect (s2) is from the Wald Z-test for the covariance parameter estimates.||0.11|-1.11|0.1065
72568348|NCT00359788|144668172|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.151||||0.163||95.0|-0.061|0.363|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.363|-0.061|0.163
72568349|NCT00359788|144668173|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.285||||0.0085||95.0|0.073|0.496|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.496|0.073|0.0085
72403720|NCT01713868|144313560|OTHER|Causal mediation analysis|Difference in proportions|0.14|||||TWO_SIDED|95.0|||||||||We performed causal mediation analyses to estimate the Total Effect of intervention on a categorical outcome as the difference in the proportion with the outcome for those who received the intervention and were positive on the mediator vs. those who received the control and were negative on the mediator. Significance is determined through 95% confidence intervals (CIs), with CIs not including 0.0 indicating significant effects.|||
72403721|NCT01713868|144313561|OTHER|Causal mediation analysis|Difference in proportions|0.15|||||TWO_SIDED|95.0|||||||||We performed causal mediation analyses to estimate the Total Effect of intervention on a categorical outcome as the difference in the proportion with the outcome for those who received the intervention and were positive on the mediator vs. those who received the control and were negative on the mediator. Significance is determined through 95% confidence intervals (CIs), with CIs not including 0.0 indicating significant effects.|||
72403722|NCT05228470|144313570|OTHER|Null hypothesis of ORR by BICR was 30%.||||||0.0076|||||||Exact binomial test|||||||0.0076
72403723|NCT03244865|144313606|NON_INFERIORITY|Non-inferiority will be verified if the RMSE between the two systems is within 7 BPM. A complete power analysis was not included as this is a pilot study.|||||<|0.1||||||Pilot Study|t-test, 2 sided|||There is only one ARM in the study. Standard monitoring and LaborView monitoring will be collected simultaneously and analyzed.||||<.1
72515349|NCT00589979|144561499|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.47||||0.0484||95.0|-0.94|0.0||All statistical tests were 2-sided with a significance level of alpha=0.05.|Linear mixed effects models||The results are reported as least squares means and their differences along with associated P-values, and 95% confidence intervals for each fixed effect in the model.|Hot: the difference between Lidoderm and placebo was compared by combining data for patients receiving the respective treatment regardless of the randomized study sequence. The endpoint was analyzed by linear mixed effects models incorporating treatment, period, sequence, and first-order carryover as fixed effects, and patient nested within sequence as a random effect. P-value for the random effect (s2) is from the Wald Z-test for the covariance parameter estimates.||-0.00|-0.94|0.0484
72515350|NCT00589979|144561499|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.24||||0.4973||95.0|-0.93|0.46||All statistical tests were 2-sided with a significance level of alpha=0.05.|Linear mixed effect models||The results are reported as least squares means and their differences along with associated P-values, and 95% confidence intervals for each fixed effect in the model.|Dull: the difference between Lidoderm and placebo was compared by combining data for patients receiving the respective treatment regardless of the randomized study sequence. The endpoint was analyzed by linear mixed effects models incorporating treatment, period, sequence, and first-order carryover as fixed effects, and patient nested within sequence as a random effect. P-value for the random effect (s2) is from the Wald Z-test for the covariance parameter estimates.||0.46|-0.93|0.4973
72515351|NCT00589979|144561499|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.12||||0.3966||95.0|-0.16|0.41||All statistical tests were 2-sided with a significance level of alpha=0.05.|Linear mixed effect models||The results are reported as least squares means and their differences along with associated P-values, and 95% confidence intervals for each fixed effect in the model.|Cold: the difference between Lidoderm and placebo was compared by combining data for patients receiving the respective treatment regardless of the randomized study sequence. The endpoint was analyzed by linear mixed effects models incorporating treatment, period, sequence, and first-order carryover as fixed effects, and patient nested within sequence as a random effect. P-value for the random effect (s2) is from the Wald Z-test for the covariance parameter estimates.||0.41|-0.16|0.3966
72515352|NCT00589979|144561499|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.09||||0.6941||95.0|-0.53|0.35||All statistical tests were 2-sided with a significance level of alpha=0.05.|Linear mixed effects model||The results are reported as least squares means and their differences along with associated P-values, and 95% confidence intervals for each fixed effect in the model.|Sensitive: the difference between Lidoderm and placebo was compared by combining data for patients receiving the respective treatment regardless of the randomized study sequence. The endpoint was analyzed by linear mixed effects models incorporating treatment, period, sequence, and first-order carryover as fixed effects, and patient nested within sequence as a random effect. P-value for the random effect (s2) is from the Wald Z-test for the covariance parameter estimates.||0.35|-0.53|0.6941
72515353|NCT00589979|144561499|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.18||||0.5664||95.0|-0.45|0.82||All statistical tests were 2-sided with a significance level of alpha=0.05.|Linear mixed effects models||The results are reported as least squares means and their differences along with associated P-values, and 95% confidence intervals for each fixed effect in the model.|Tender: the difference between Lidoderm and placebo was compared by combining data for patients receiving the respective treatment regardless of the randomized study sequence. The endpoint was analyzed by linear mixed effects models incorporating treatment, period, sequence, and first-order carryover as fixed effects, and patient nested within sequence as a random effect. P-value for the random effect (s2) is from the Wald Z-test for the covariance parameter estimates.||0.82|-0.45|0.5664
72542486|NCT00106028|144614701|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.686||||0.3826|TWO_SIDED|95.0|-15.276|5.903|||ANCOVA|LS means and p-value are from ANCOVA model adjusted by baseline and fixed effects for age group, treatment and pooled center for post-baseline.||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.||5.903|-15.276|0.3826
72542487|NCT00106028|144614702|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-26.629|||<|0.0001||95.0|-38.089|-15.169|||ANCOVA|LS means and p-value are from ANCOVA model adjusted by baseline and fixed effects for age group, treatment and pooled center for post-baseline.||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.||-15.169|-38.089|<0.0001
72403724|NCT05620576|144313607|SUPERIORITY||Posterior Mean Difference|0.1|||||TWO_SIDED|95.0|-0.61|0.82|||||Posterior mean difference with 95% credible interval is reported.|||0.82|-0.61|
72403725|NCT05620576|144313608|SUPERIORITY||Posterior Mean Difference|0.26|||||TWO_SIDED|95.0|-0.47|0.99|||||Posterior mean difference with 95% credible interval is reported.|||0.99|-0.47|
72403726|NCT05620576|144313609|SUPERIORITY||Posterior Mean Difference|0.33|||||TWO_SIDED|95.0|-0.11|0.78|||||Posterior mean difference with 95% credible interval is reported.|||0.78|-0.11|
72403727|NCT05620576|144313610|SUPERIORITY||Posterior Mean Difference|0.2|||||TWO_SIDED|95.0|-0.56|0.96|||||Posterior mean difference with 95% credible interval is reported.|||0.96|-0.56|
72403728|NCT05620576|144313611|SUPERIORITY||Posterior Mean Difference|-0.77|||||TWO_SIDED|95.0|-9.41|7.75|||||Posterior mean difference with 95% credible interval is reported.|||7.75|-9.41|
72403729|NCT05620576|144313612|SUPERIORITY||Posterior Mean Difference|-0.13|||||TWO_SIDED|95.0|-0.51|0.24|||||Posterior mean difference with 95% credible interval is reported.|||0.24|-0.51|
72403730|NCT05620576|144313613|SUPERIORITY||Posterior Mean Difference|-0.01|||||TWO_SIDED|95.0|-0.11|0.08|||||Posterior mean difference with 95% credible interval is reported.|||0.08|-0.11|
72403731|NCT05620576|144313614|SUPERIORITY||Posterior Mean Difference|23.02|||||TWO_SIDED|95.0|-108.05|152.33|||||Posterior mean difference with 95% credible interval is reported.|||152.33|-108.05|
72403732|NCT05394025|144313618|SUPERIORITY||Interaction|0.02||||0.77|TWO_SIDED|95.0|-0.13|0.18|||likelihood ratio test||Beta for time by COVID-19 status|Null hypothesis no difference in trends of I/ADL scores between Veterans with COVID-19 and comparators. We used adjusted linear mixed model (LMM) to model ADL scores over time (i.e., survey cycles) and by COVID-19 status. The LMM included an interaction term for time and COVID-19 status. LMM models were fitted with random intercepts (i.e., patient ID) and slopes (i.e., survey cycle). LMMs included fixed effects for patient baseline age, sex, and care assessment needs score.||0.18|-0.13|0.77
72515354|NCT00589979|144561499|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.09||||0.6871||95.0|-0.55|0.37||All statistical tests were 2-sided with a significance level of alpha=0.05.|Linear mixed effects models||The results are reported as least squares means and their differences along with associated P-values, and 95% confidence intervals for each fixed effect in the model.|Itchy: the difference between Lidoderm and placebo was compared by combining data for patients receiving the respective treatment regardless of the randomized study sequence. The endpoint was analyzed by linear mixed effects models incorporating treatment, period, sequence, and first-order carryover as fixed effects, and patient nested within sequence as a random effect. P-value for the random effect (s2) is from the Wald Z-test for the covariance parameter estimates.||0.37|-0.55|0.6871
72515355|NCT00589979|144561499|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.41||||0.2318||95.0|-1.08|0.27||All statistical tests were 2-sided with a significance level of alpha=0.05.|Linear mixed effects models||The results are reported as least squares means and their differences along with associated P-values, and 95% confidence intervals for each fixed effect in the model.|Shocking: the difference between Lidoderm and placebo was compared by combining data for patients receiving the respective treatment regardless of the randomized study sequence. The endpoint was analyzed by linear mixed effects models incorporating treatment, period, sequence, and first-order carryover as fixed effects, and patient nested within sequence as a random effect. P-value for the random effect (s2) is from the Wald Z-test for the covariance parameter estimates.||0.27|-1.08|0.2318
72568350|NCT01366443|144668182|SUPERIORITY_OR_OTHER||Sensitivity|0.85|||||TWO_SIDED|95.0|0.79|0.89|||||"The calculation for the Wilson CI is computed using the cii (confidence interval immediate) command in Stata version 11.2, with the Wilson option."|Sensitivity = true positives/(true positives + false negatives); It indicates how likely is the test to detect the presence of a characteristic in someone with the characteristic.||0.89|0.79|
72568351|NCT01366443|144668182|SUPERIORITY_OR_OTHER||Specificity|0.98|||||TWO_SIDED|95.0|0.93|0.99|||||"The calculation for the Wilson CI is computed using the cii (confidence interval immediate) command in Stata version 11.2, with the Wilson option."|Specificity = true negatives/(false positives + true negatives); It indicates how likely the test is to detect the absence of a characteristic in someone without the characteristic.||0.99|0.93|
72577116|NCT02045147|144680860|OTHER||Mean Difference (Final Values)|-4.5|STANDARD_ERROR_OF_MEAN|3.8||0.254|TWO_SIDED|95.0|-12.3|3.4|||t-test, 2 sided|||||3.4|-12.3|0.254
72403733|NCT05394025|144313618|SUPERIORITY||Mean Difference (Final Values)|0.12||||0.6|TWO_SIDED|95.0|-0.44|0.67|||likelihood ratio test||Beta coefficient for mean difference in mean longitudinal I/ADL score|Null hypothesis no difference in trends of I/ADL scores between Veterans with COVID-19 and comparators. We used adjusted linear mixed model (LMM) to model I/ADL scores over time (i.e., survey cycles) and by COVID-19 status. The LMM included an interaction term for time and COVID-19 status. LMM models were fitted with random intercepts (i.e., patient ID) and slopes (i.e., survey cycle). LMMs included fixed effects for patient baseline age, sex, and care assessment needs score.||0.67|-0.44|0.60
72403734|NCT01536496|144313622|SUPERIORITY_OR_OTHER|||||||0.04|TWO_SIDED||||||Chi-squared|||Chi-square test||||0.04
72403735|NCT03249779|144313644|SUPERIORITY|||||||0.0396|||||||t-test, 2 sided|||||||0.0396
72403736|NCT03249779|144313645|SUPERIORITY|||||||0.133|||||||t-test, 2 sided|||||||0.1330
72403737|NCT03314584|144313648|SUPERIORITY||||||<|0|||||||Mixed Models Analysis|F=21.662, df = 1||||||<0.000
72403738|NCT03314584|144313649|SUPERIORITY|||||||0.004|||||||Mixed Models Analysis|F=5.624, df=1||||||0.004
72403739|NCT03314584|144313650|SUPERIORITY|||||||0.046|||||||Mixed Models Analysis|F=3.092, df=1||||||0.046
72403740|NCT03314584|144313651|SUPERIORITY|||||||0.018|||||||Mixed Models Analysis|F=4.022, df=1||||||0.018
72403741|NCT03314584|144313652|SUPERIORITY|||||||0.598|||||||Mixed Models Analysis|F=0.279, df=1||||||0.598
72403742|NCT03314584|144313653|SUPERIORITY|||||||0.296|||||||Mixed Models Analysis|F=1.101, df=1||||||0.296
72403743|NCT03314584|144313654|SUPERIORITY|||||||0.033|||||||Mixed Models Analysis|F=4.672, df = 1||||||0.033
72403744|NCT03314584|144313655|SUPERIORITY|||||||0.606|||||||Mixed Models Analysis|F=0.268, df=1||||||0.606
72403745|NCT03314584|144313656|SUPERIORITY|||||||0.287|||||||Mixed Models Analysis|F=1.142, df=1||||||0.287
72403746|NCT03314584|144313657|SUPERIORITY|||||||0.049|||||||Mixed Models Analysis|F=4.039, df=1||||||0.049
72403747|NCT03314584|144313658|SUPERIORITY|||||||0.338|||||||Mixed Models Analysis|F=1.084, df=1||||||0.338
72403748|NCT04302389|144313680|OTHER||||||<|0.001|||||||t-test, 2 sided|||This was a within-subject comparison at two timepoints (baseline, 3 months)||||<0.001
72403749|NCT04214288|144313701|SUPERIORITY||Hazard Ratio (HR)|0.59||||0.0167||90.0|0.42|0.82|||Log Rank|The analysis was performed using a stratified Cox Proportional Hazards model.|A hazard ratio \< 1 favours AZD9833 to be associated with a longer progression-free survival than fulvestrant.|||0.82|0.42|0.0167
72403750|NCT04214288|144313701|SUPERIORITY||Hazard Ratio (HR)|0.64||||0.009||90.0|0.46|0.89|||Log Rank|The analysis was performed using a stratified Cox Proportional Hazards model.|A hazard ratio \< 1 favours AZD9833 to be associated with a longer progression-free survival than fulvestrant.|||0.89|0.46|0.0090
72403751|NCT04214288|144313702|SUPERIORITY||Odds Ratio (OR)|1.42||||0.4828||90.0|0.63|3.31|||Regression, Logistic|The analysis was performed using logistic regression model adjusting for prior use of CDK4/6 inhibitors and presence of lung and/or liver metastasis.|An odds ratio \> 1 favours AZD9833.|||3.31|0.63|0.4828
72488267|NCT01431274|144505145|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.115|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|0.09|0.139||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Tiotropium (5 μg).~Spatial power covariance structure for within-patient errors."|||0.139|0.090|<0.0001
72488268|NCT01431274|144505145|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.119|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|0.094|0.143||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within-patient errors."|||0.143|0.094|<0.0001
72488269|NCT01431274|144505145|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.099|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|0.074|0.123||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.123|0.074|<0.0001
72488270|NCT01431274|144505145|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.092|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|0.067|0.117||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (5 µg).~Spatial power covariance structure for within-patient errors."|||0.117|0.067|<0.0001
72488271|NCT01431274|144505145|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.023|STANDARD_ERROR_OF_MEAN|0.013||0.0717|TWO_SIDED|95.0|-0.002|0.047||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tio+Olo FDC (2.5/5 µg).~Spatial power covariance structure for within-patient errors."|||0.047|-0.002|0.0717
72488272|NCT01431274|144505145|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.121|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|0.097|0.146||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.146|0.097|<0.0001
72488273|NCT01431274|144505145|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.027|STANDARD_ERROR_OF_MEAN|0.013||0.0344|TWO_SIDED|95.0|0.002|0.051||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within-patient errors."|||0.051|0.002|0.0344
72515356|NCT00589979|144561499|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.21||||0.3383||95.0|-0.64|0.22||All statistical tests were 2-sided with a significance level of alpha=0.05.|Linear mixed effects models||The results are reported as least squares means and their differences along with associated P-values, and 95% confidence intervals for each fixed effect in the model.|Numb: the difference between Lidoderm and placebo was compared by combining data for patients receiving the respective treatment regardless of the randomized study sequence. The endpoint was analyzed by linear mixed effects models incorporating treatment, period, sequence, and first-order carryover as fixed effects, and patient nested within sequence as a random effect. P-value for the random effect (s2) is from the Wald Z-test for the covariance parameter estimates.||0.22|-0.64|0.3383
72577117|NCT02045147|144680860|OTHER||Mean Difference (Final Values)|-0.9|STANDARD_ERROR_OF_MEAN|2.7||0.759|TWO_SIDED|95.0|-6.3|4.6|||t-test, 2 sided|||||4.6|-6.3|0.759
72577118|NCT02045147|144680861|OTHER||Mean Difference (Final Values)|5.2|STANDARD_ERROR_OF_MEAN|3.6||0.153|TWO_SIDED|95.0|-2.1|12.7|||t-test, 2 sided|||||12.7|-2.1|0.153
72403752|NCT04214288|144313702|SUPERIORITY||Odds Ratio (OR)|1.57||||0.3691||90.0|0.69|3.67|||Regression, Logistic|The analysis was performed using logistic regression model adjusting for prior use of CDK4/6 inhibitors and presence of lung and/or liver metastasis.|An odds ratio \> 1 favours AZD9833.|||3.67|0.69|0.3691
72403753|NCT04214288|144313706|SUPERIORITY||Odds Ratio (OR)|1.48||||0.2554|TWO_SIDED|90.0|0.84|2.64|||Regression, Logistic|The analysis was performed using logistic regression model adjusting for prior use of CDK4/6 inhibitors and presence of lung and/or liver metastasis.|An odds ratio \> 1 favours AZD9833.|||2.64|0.84|0.2554
72403754|NCT04214288|144313706|SUPERIORITY||Odds Ratio (OR)|1.62||||0.1658||90.0|0.91|2.89|||Regression, Logistic|The analysis was performed using logistic regression model adjusting for prior use of CDK4/6 inhibitors and presence of lung and/or liver metastasis.|An odds ratio \> 1 favours AZD9833.|||2.89|0.91|0.1658
72403755|NCT03792672|144313712|SUPERIORITY||Least square mean (LSM) difference|115.0|STANDARD_ERROR_OF_MEAN|144.0||0.4278|TWO_SIDED|90.0|-128.0|359.0||Based on mixed model analysis, with treatment, period, sequence, treatment-by-period interaction as fixed factors, participant within sequence as a random factor, baseline as a covariate.|Mixed Models Analysis|||||359|-128|0.4278
72403756|NCT03792672|144313712|SUPERIORITY||LSM difference|338.0|STANDARD_ERROR_OF_MEAN|147.0||0.0269|TWO_SIDED|90.0|90.5|585.0||Based on mixed model analysis, with treatment, period, sequence, treatment-by-period interaction as fixed factors, participant within sequence as a random factor, baseline as a covariate.|Mixed Models Analysis|||||585|90.5|0.0269
72488274|NCT01431274|144505145|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.02|STANDARD_ERROR_OF_MEAN|0.013||0.1126|TWO_SIDED|95.0|-0.005|0.045||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (2.5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within-patient errors."|||0.045|-0.005|0.1126
72488275|NCT01431274|144505145|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.007|STANDARD_ERROR_OF_MEAN|0.013||0.6009|TWO_SIDED|95.0|-0.018|0.031||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.031|-0.018|0.6009
72488276|NCT01431274|144505146|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.072|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|0.049|0.096||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within-patient errors."|||0.096|0.049|<0.0001
72488277|NCT01431274|144505146|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.063|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|0.039|0.087||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Tiotropium (5 μg).~Spatial power covariance structure for within-patient errors."|||0.087|0.039|<0.0001
72488278|NCT01431274|144505146|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.047|STANDARD_ERROR_OF_MEAN|0.012||0.0001|TWO_SIDED|95.0|0.023|0.07||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within-patient errors."|||0.070|0.023|0.0001
72488279|NCT01431274|144505146|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.03|STANDARD_ERROR_OF_MEAN|0.012||0.0122|TWO_SIDED|95.0|0.007|0.054||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.054|0.007|0.0122
72488280|NCT01431274|144505146|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.037|STANDARD_ERROR_OF_MEAN|0.012||0.0021|TWO_SIDED|95.0|0.014|0.061||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (5 µg).~Spatial power covariance structure for within-patient errors."|||0.061|0.014|0.0021
72542488|NCT00106028|144614703|SUPERIORITY_OR_OTHER||Mean Difference (Net)|9.04||||0.3075|TWO_SIDED|95.0|-8.433|26.512|||ANCOVA|LS means and p-value are from ANCOVA model adjusted by baseline and fixed effects for age group, treatment and pooled center for post-baseline.||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.||26.512|-8.433|0.3075
72488281|NCT01431274|144505146|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.026|STANDARD_ERROR_OF_MEAN|0.012||0.0347|TWO_SIDED|95.0|0.002|0.049||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tio+Olo FDC (2.5/5 µg).~Spatial power covariance structure for within-patient errors."|||0.049|0.002|0.0347
72488282|NCT01431274|144505146|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.056|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|0.032|0.08||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.080|0.032|<0.0001
72488283|NCT01431274|144505146|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.009|STANDARD_ERROR_OF_MEAN|0.012||0.4407|TWO_SIDED|95.0|-0.014|0.033||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Olodaterol (5 μg).~Spatial power covariance structure for within-patient errors."|||0.033|-0.014|0.4407
72568352|NCT01366443|144668182|SUPERIORITY_OR_OTHER||Positive Predictive Value|0.99|||||TWO_SIDED|95.0|0.96|1.0|||||"The calculation for the Wilson CI is computed using the cii (confidence interval immediate) command in Stata version 11.2, with the Wilson option."|Positive Predictive Value = true positives/(true positives + false positives); It indicates how likely it is that someone with a positive test result will actually have the characteristic.||1.00|0.96|
72568353|NCT01366443|144668182|SUPERIORITY_OR_OTHER||Negative Predictive Value|0.77|||||TWO_SIDED|95.0|0.69|0.84|||||"The calculation for the Wilson CI is computed using the cii (confidence interval immediate) command in Stata version 11.2, with the Wilson option."|Negative Predictive Value = true negatives/(true negatives + false negatives); It indicates how likely it is that someone with a negative test result will actually not have the characteristic.||0.84|0.69|
72568354|NCT01366443|144668182|SUPERIORITY_OR_OTHER||Sensitivity|0.99|||||TWO_SIDED|95.0|0.97|1.0|||||"The calculation for the Wilson CI is computed using the cii (confidence interval immediate) command in Stata version 11.2, with the Wilson option."|Sensitivity = true positives/(true positives + false negatives); It indicates how likely is the test to detect the presence of a characteristic in someone with the characteristic.||1.00|0.97|
72515357|NCT00589979|144561499|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.05||||0.874||95.0|-0.63|0.73||All statistical tests were 2-sided with a significance level of alpha=0.05.|Linear mixed effects models||The results are reported as least squares means and their differences along with associated P-values, and 95% confidence intervals for each fixed effect in the model.|Electrical: the difference between Lidoderm and placebo was compared by combining data for patients receiving the respective treatment regardless of the randomized study sequence. The endpoint was analyzed by linear mixed effects models incorporating treatment, period, sequence, and first-order carryover as fixed effects, and patient nested within sequence as a random effect. P-value for the random effect (s2) is from the Wald Z-test for the covariance parameter estimates.||0.73|-0.63|0.8740
72515358|NCT00589979|144561499|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0||||0.999||95.0|-0.54|0.54||All statistical tests were 2-sided with a significance level of alpha=0.05.|Linear mixed effects models||The results are reported as least squares means and their differences along with associated P-values, and 95% confidence intervals for each fixed effect in the model.|Tingling: the difference between Lidoderm and placebo was compared by combining data for patients receiving the respective treatment regardless of the randomized study sequence. The endpoint was analyzed by linear mixed effects models incorporating treatment, period, sequence, and first-order carryover as fixed effects, and patient nested within sequence as a random effect. P-value for the random effect (s2) is from the Wald Z-test for the covariance parameter estimates.||0.54|-0.54|0.9990
72515359|NCT00589979|144561499|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.25||||0.4183||95.0|-0.85|0.36||All statistical tests were 2-sided with a significance level of alpha=0.05.|Linear mixed effects models||The results are reported as least squares means and their differences along with associated P-values, and 95% confidence intervals for each fixed effect in the model.|Cramping: the difference between Lidoderm and placebo was compared by combining data for patients receiving the respective treatment regardless of the randomized study sequence. The endpoint was analyzed by linear mixed effects models incorporating treatment, period, sequence, and first-order carryover as fixed effects, and patient nested within sequence as a random effect. P-value for the random effect (s2) is from the Wald Z-test for the covariance parameter estimates.||0.36|-0.85|0.4183
72515360|NCT00589979|144561499|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.07||||0.8227||95.0|-0.71|0.57||All statistical tests were 2-sided with a significance level of alpha=0.05.|Linear mixed effects models||The results are reported as least squares means and their differences along with associated P-values, and 95% confidence intervals for each fixed effect in the model.|Radiating: the difference between Lidoderm and placebo was compared by combining data for patients receiving the respective treatment regardless of the randomized study sequence. The endpoint was analyzed by linear mixed effects models incorporating treatment, period, sequence, and first-order carryover as fixed effects, and patient nested within sequence as a random effect. P-value for the random effect (s2) is from the Wald Z-test for the covariance parameter estimates.||0.57|-0.71|0.8227
72515361|NCT00589979|144561499|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.18||||0.587||95.0|-0.48|0.85||All statistical tests were 2-sided with a significance level of alpha=0.05.|Linear mixed effects models||The results are reported as least squares means and their differences along with associated P-values, and 95% confidence intervals for each fixed effect in the model.|Throbbing: the difference between Lidoderm and placebo was compared by combining data for patients receiving the respective treatment regardless of the randomized study sequence. The endpoint was analyzed by linear mixed effects models incorporating treatment, period, sequence, and first-order carryover as fixed effects, and patient nested within sequence as a random effect. P-value for the random effect (s2) is from the Wald Z-test for the covariance parameter estimates.||0.85|-0.48|0.5870
72515362|NCT00589979|144561499|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.44||||0.2181||95.0|-1.15|0.27||All statistical tests were 2-sided with a significance level of alpha=0.05.|Linear mixed effects models||The results are reported as least squares means and their differences along with associated P-values, and 95% confidence intervals for each fixed effect in the model.|Aching: the difference between Lidoderm and placebo was compared by combining data for patients receiving the respective treatment regardless of the randomized study sequence. The endpoint was analyzed by linear mixed effects models incorporating treatment, period, sequence, and first-order carryover as fixed effects, and patient nested within sequence as a random effect. P-value for the random effect (s2) is from the Wald Z-test for the covariance parameter estimates.||0.27|-1.15|0.2181
72515363|NCT00589979|144561499|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.13||||0.6276||95.0|-0.68|0.42||All statistical tests were 2-sided with a significance level of alpha=0.05.|Linear mixed effects models||The results are reported as least squares means and their differences along with associated P-values, and 95% confidence intervals for each fixed effect in the model.|Heavy: the difference between Lidoderm and placebo was compared by combining data for patients receiving the respective treatment regardless of the randomized study sequence. The endpoint was analyzed by linear mixed effects models incorporating treatment, period, sequence, and first-order carryover as fixed effects, and patient nested within sequence as a random effect. P-value for the random effect (s2) is from the Wald Z-test for the covariance parameter estimates.||0.42|-0.68|0.6276
72568355|NCT01366443|144668182|SUPERIORITY_OR_OTHER||Specificity|0.91|||||TWO_SIDED|95.0|0.83|0.95|||||"The calculation for the Wilson CI is computed using the cii (confidence interval immediate) command in Stata version 11.2, with the Wilson option."|Specificity = true negatives/(false positives + true negatives); It indicates how likely the test is to detect the absence of a characteristic in someone without the characteristic.||0.95|0.83|
72568356|NCT01366443|144668182|SUPERIORITY_OR_OTHER||Positive Predictive Value|0.95|||||TWO_SIDED|95.0|0.9|0.98|||||"The calculation for the Wilson CI is computed using the cii (confidence interval immediate) command in Stata version 11.2, with the Wilson option."|Positive Predictive Value = true positives/(true positives + false positives); It indicates how likely it is that someone with a positive test result will actually have the characteristic.||0.98|0.90|
72577119|NCT02045147|144680861|OTHER||Mean Difference (Final Values)|-1.2|STANDARD_ERROR_OF_MEAN|3.3||0.729|TWO_SIDED|95.0|-7.9|5.5|||t-test, 2 sided|||||5.5|-7.9|0.729
72403757|NCT03792672|144313713|SUPERIORITY||LSM difference|-0.388|STANDARD_ERROR_OF_MEAN|0.582||0.5089|TWO_SIDED|90.0|-1.37|0.595||Based on mixed model analysis, with treatment, period, sequence, treatment-by-period interaction as fixed factors, participant within sequence as a random factor, baseline as a covariate.|Mixed Models Analysis|||||0.595|-1.37|0.5089
72403758|NCT03792672|144313713|SUPERIORITY||LSM difference|-0.209|STANDARD_ERROR_OF_MEAN|0.581||0.7208|TWO_SIDED|90.0|-1.19|0.773||Based on mixed model analysis, with treatment, period, sequence, treatment-by-period interaction as fixed factors, participant within sequence as a random factor, baseline as a covariate.|Mixed Models Analysis|||||0.773|-1.19|0.7208
72577120|NCT02045147|144680861|OTHER||Mean Difference (Final Values)|0.5|STANDARD_ERROR_OF_MEAN|3.5||0.886|TWO_SIDED|95.0|-6.6|7.6|||t-test, 2 sided|||||7.6|-6.6|0.886
72403759|NCT03792672|144313714|SUPERIORITY||LSM difference|14.0|STANDARD_ERROR_OF_MEAN|17.1||0.4174|TWO_SIDED|90.0|-14.8|42.8||Based on mixed model analysis, with treatment, period, sequence, treatment-by-period interaction as fixed factors, participant within sequence as a random factor, baseline as a covariate.|Mixed Models Analysis|||LICI 50 ms peak-to-peak amplitude||42.8|-14.8|0.4174
72403760|NCT03792672|144313714|SUPERIORITY||LSM difference|15.1|STANDARD_ERROR_OF_MEAN|17.1||0.3832|TWO_SIDED|90.0|-25.3|31.5||Based on mixed model analysis, with treatment, period, sequence, treatment-by-period interaction as fixed factors, participant within sequence as a random factor, baseline as a covariate.|Mixed Models Analysis|||LICI 50 ms peak-to-peak amplitude||31.5|-25.3|0.3832
72488284|NCT01431274|144505146|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.016|STANDARD_ERROR_OF_MEAN|0.012||0.1777|TWO_SIDED|95.0|-0.007|0.04||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (2.5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within-patient errors."|||0.040|-0.007|0.1777
72488285|NCT01431274|144505146|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.007|STANDARD_ERROR_OF_MEAN|0.012||0.5641|TWO_SIDED|95.0|-0.031|0.017||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.017|-0.031|0.5641
72488286|NCT01431274|144505147|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.08|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|0.057|0.104||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within-patient errors."|||0.104|0.057|<0.0001
72488287|NCT01431274|144505147|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.075|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|0.051|0.099||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Tiotropium (5 μg).~Spatial power covariance structure for within-patient errors."|||0.099|0.051|<0.0001
72488288|NCT01431274|144505147|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.038|STANDARD_ERROR_OF_MEAN|0.012||0.0018|TWO_SIDED|95.0|0.014|0.062||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within-patient errors."|||0.062|0.014|0.0018
72488289|NCT01431274|144505147|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.024|STANDARD_ERROR_OF_MEAN|0.012||0.0517|TWO_SIDED|95.0|0.0|0.047||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.047|-0.000|0.0517
72488290|NCT01431274|144505147|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.033|STANDARD_ERROR_OF_MEAN|0.012||0.0072|TWO_SIDED|95.0|0.009|0.056||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (5 µg).~Spatial power covariance structure for within-patient errors."|||0.056|0.009|0.0072
72488291|NCT01431274|144505147|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.042|STANDARD_ERROR_OF_MEAN|0.012||0.0005|TWO_SIDED|95.0|0.019|0.066||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tio+Olo FDC (2.5/5 µg).~Spatial power covariance structure for within-patient errors."|||0.066|0.019|0.0005
72488292|NCT01431274|144505147|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.066|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|0.042|0.09||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.090|0.042|<0.0001
72488293|NCT01431274|144505147|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.005|STANDARD_ERROR_OF_MEAN|0.012||0.6619|TWO_SIDED|95.0|-0.018|0.029||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within-patient errors."|||0.029|-0.018|0.6619
72403761|NCT03792672|144313714|SUPERIORITY||LSM difference|-0.326|STANDARD_ERROR_OF_MEAN|4.09||0.9368|TWO_SIDED|90.0|-7.23|6.58||Based on mixed model analysis, with treatment, period, sequence, treatment-by-period interaction as fixed factors, participant within sequence as a random factor, baseline as a covariate.|Mixed Models Analysis|||LICI 100 ms peak-to-peak amplitude||6.58|-7.23|0.9368
72403762|NCT03792672|144313714|SUPERIORITY||LSM difference|3.71|STANDARD_ERROR_OF_MEAN|4.16||0.379|TWO_SIDED|90.0|-3.32|10.7||Based on mixed model analysis, with treatment, period, sequence, treatment-by-period interaction as fixed factors, participant within sequence as a random factor, baseline as a covariate.|Mixed Models Analysis|||LICI 100 ms peak-to-peak amplitude||10.7|-3.32|0.3790
72515364|NCT00589979|144561499|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.57||||0.0917||95.0|-1.23|0.09||All statistical tests were 2-sided with a significance level of alpha=0.05.|Linear mixed effects models||The results are reported as least squares means and their differences along with associated P-values, and 95% confidence intervals for each fixed effect in the model.|Overall unpleasantness: the difference between Lidoderm and placebo was compared by combining data for patients receiving the respective treatment regardless of the randomized study sequence. The endpoint was analyzed by linear mixed effects models incorporating treatment, period, sequence, and first-order carryover as fixed effects, and patient nested within sequence as a random effect. P-value for the random effect (s2) is from the Wald Z-test for the covariance parameter estimates.||0.09|-1.23|0.0917
72515365|NCT00589979|144561499|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.44||||0.2089||95.0|-1.13|0.25||All statistical tests were 2-sided with a significance level of alpha=0.05.|Linear mixed effects models||The results are reported as least squares means and their differences along with associated P-values, and 95% confidence intervals for each fixed effect in the model.|Intense deep pain: the difference between Lidoderm and placebo was compared by combining data for patients receiving the respective treatment regardless of the randomized study sequence. The endpoint was analyzed by linear mixed effects models incorporating treatment, period, sequence, and first-order carryover as fixed effects, and patient nested within sequence as a random effect. P-value for the random effect (s2) is from the Wald Z-test for the covariance parameter estimates.||0.25|-1.13|0.2089
72515366|NCT00589979|144561499|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.22||||0.4188||95.0|-0.75|0.31||All statistical tests were 2-sided with a significance level of alpha=0.05.|Linear mixed effects models||The results are reported as least squares means and their differences along with associated P-values, and 95% confidence intervals for each fixed effect in the model.|Intense surface pain: the difference between Lidoderm and placebo was compared by combining data for patients receiving the respective treatment regardless of the randomized study sequence. The endpoint was analyzed by linear mixed effects models incorporating treatment, period, sequence, and first-order carryover as fixed effects, and patient nested within sequence as a random effect. P-value for the random effect (s2) is from the Wald Z-test for the covariance parameter estimates.||0.31|-0.75|0.4188
72515367|NCT00589979|144561499|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.05||||0.6959||95.0|-0.32|0.21||All statistical tests were 2-sided with a significance level of alpha=0.05.|Linear mixed effects models||The results are reported as least squares means and their differences along with associated P-values, and 95% confidence intervals for each fixed effect in the model.|Average surface pain: the difference between Lidoderm and placebo was compared by combining data for patients receiving the respective treatment regardless of the randomized study sequence. The endpoint was analyzed by linear mixed effects models incorporating treatment, period, sequence, and first-order carryover as fixed effects, and patient nested within sequence as a random effect. P-value for the random effect (s2) is from the Wald Z-test for the covariance parameter estimates.||0.21|-0.32|0.6959
72515368|NCT00589979|144561499|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.17||||0.4806||95.0|-0.64|0.3||All statistical tests were 2-sided with a significance level of alpha=0.05.|Linear mixed effects models||The results are reported as least squares means and their differences along with associated P-values, and 95% confidence intervals for each fixed effect in the model.|Average deep pain: the difference between Lidoderm and placebo was compared by combining data for patients receiving the respective treatment regardless of the randomized study sequence. The endpoint was analyzed by linear mixed effects models incorporating treatment, period, sequence, and first-order carryover as fixed effects, and patient nested within sequence as a random effect. P-value for the random effect (s2) is from the Wald Z-test for the covariance parameter estimates.||0.30|-0.64|0.4806
72515369|NCT00589979|144561499|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.28||||0.2291||95.0|-0.74|0.18||All statistical tests were 2-sided with a significance level of alpha=0.05.|Linear mixed effects models||The results are reported as least squares means and their differences along with associated P-values, and 95% confidence intervals for each fixed effect in the model.|Average paroxysmal pain: the difference between Lidoderm and placebo was compared by combining data for patients receiving the respective treatment regardless of the randomized study sequence. The endpoint was analyzed by linear mixed effects models incorporating treatment, period, sequence, and first-order carryover as fixed effects, and patient nested within sequence as a random effect. P-value for the random effect (s2) is from the Wald Z-test for the covariance parameter estimates.||0.18|-0.74|0.2291
72515370|NCT00589979|144561500|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.32||||0.3185||95.0|0.77|2.27||All statistical tests were 2-sided with a significance level of alpha=0.05.|Regression, Linear||The Odds Ratio (OR) provided is the ratio of Lidoderm to Placebo.|Global impression of change from baseline with the lidocaine patch 5% and placebo patch were compared by combining data for patients receiving the respective treatment regardless of the randomized study sequence. An ordinal multinomial regression model was performed with sequence, period, treatment, carry over effect as fixed effects, with repeated measures taken on patient within sequence.||2.27|0.77|0.3185
72515371|NCT00589979|144561501|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.22||||0.4748||95.0|0.72|2.06||All statistical tests were 2-sided with a significance level of alpha=0.05.|Regression, Linear||The odds ratio (OR) provided is the ratio of Lidoderm to Placebo.|Global impression of change from baseline with the lidocaine patch 5% and placebo patch were compared by combining data for patients receiving the respective treatment regardless of the randomized study sequence. An ordinal multinomial regression model was performed with sequence, period, treatment, carry over effect as fixed effects, with repeated measures taken on patient within sequence.||2.06|0.72|0.4748
72515372|NCT00589979|144561502|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.12||||0.7839||95.0|-0.74|0.98||All statistical tests were 2-sided with a significance level of alpha=0.05.|Linear mixed effects models||The results are reported as least squares means and their differences along with associated P-values, and 95% confidence intervals for each fixed effect in the model.|The overall treatment difference for the lidocaine patch 5% and placebo patch was compared by combining data for patients receiving the respective treatment regardless of randomized study sequence. The endpoint was analyzed by linear mixed effects models incorporating treatment, period, sequence, and first-order carryover as fixed effects, and patient nested within sequence as a random effect. P-value for the random effect (s2) is from the Wald Z-test for the covariance parameter estimates.||0.98|-0.74|0.7839
72515373|NCT00589979|144561504|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.01||||0.3773||95.0|-0.02|0.04||All statistical tests were 2-sided with a significance level of alpha=0.05.|Linear mixed effects model||The results are reported as least squares means and their differences along with associated P-values, and 95% confidence intervals for each fixed effect in the model.|The overall treatment difference for the lidocaine patch 5% and placebo patch was compared by combining data for patients receiving the respective treatment regardless of randomized study sequence. The endpoint was analyzed by linear mixed effects models incorporating treatment, period, sequence, and first-order carryover as fixed effects, and patient nested within sequence as a random effect. P-value for the random effect (s2) is from the Wald Z-test for the covariance parameter estimates.||0.04|-0.02|0.3773
72515374|NCT00589979|144561505|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.71||||0.2605||95.0|0.38|1.3||All statistical tests were 2-sided with a significance level of alpha=0.05.|Regression, Linear||The odds ratio (OR) provided is the ratio of Lidoderm to Placebo.|Treatment satisfaction with the lidocaine patch 5% and placebo patch were compared by combining data for patients receiving the respective treatment regardless of the randomized study sequence. An ordinal multinomial regression model was performed with sequence, period, treatment, carry over effect as fixed effects, with repeated measures taken on patient within sequence.||1.30|0.38|0.2605
72515375|NCT00589979|144561506|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.76||||0.3193||95.0|0.44|1.3||All statistical tests were 2-sided with a significance level of alpha=0.05.|Regression, Linear||The odds ratio (OR) provided is the ratio of Lidoderm to Placebo.|Treatment satisfaction with the lidocaine patch 5% and placebo patch were compared by combining data for patients receiving the respective treatment regardless of the randomized study sequence. An ordinal multinomial regression model was performed with sequence, period, treatment, carry over effect as fixed effects, with repeated measures taken on patient within sequence.||1.30|0.44|0.3193
72515376|NCT00589979|144561507|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.74||||0.1378||95.0|-0.57|4.04||All statistical tests were 2-sided with a significance level of alpha=0.05.|Linear mixed effects model||The results are reported as least squares means and their differences along with associated P-values, and 95% confidence intervals for each fixed effect in the model.|The overall treatment difference for the lidocaine patch 5% and placebo patch was compared by combining data for patients receiving the respective treatment regardless of randomized study sequence. The endpoint was analyzed by linear mixed effects models incorporating treatment, period, sequence, and first-order carryover as fixed effects, and patient nested within sequence as a random effect. P-value for the random effect (s2) is from the Wald Z-test for the covariance parameter estimates||4.04|-0.57|0.1378
72515377|NCT00589979|144561508|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.88||||0.6833||95.0|0.47|1.65||All statistical tests were 2-sided with a significance level of alpha=0.05.|Regression, Logistic|An ordinal multinomial regression model was performed with sequence, period, treatment, carry over effect as fixed effects.|The Odds Ratio (OR) provided is the ratio of Lidoderm to Placebo.|||1.65|0.47|0.6833
72515378|NCT00589979|144561509|SUPERIORITY_OR_OTHER||Mean Difference (Net)|22.16||||0.1143||95.0|-5.48|49.8||All statistical tests were 2-sided with a significance level of alpha=0.05.|Linear mixed effects models||The results are reported as least squares means and their differences along with associated P-values, and 95% confidence intervals for each fixed effect in the model.|Disturbance: the overall treatment difference for Lidoderm and placebo patch was compared by combining data for patients receiving the respective treatment regardless of randomized study sequence. The endpoint was analyzed by linear mixed effects models incorporating treatment, period, sequence, and first-order carryover as fixed effects, and patient nested within sequence as a random effect. P-value for the random effect (s2) is from the Wald Z-test for the covariance parameter estimates.||49.8|-5.48|0.1143
72542489|NCT00106028|144614704|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.039||||0.3998|TWO_SIDED|95.0|-16.849|6.772|||ANCOVA|LS means and p-value are from ANCOVA model adjusted by baseline and fixed effects for age group, treatment and pooled center for post-baseline.||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.||6.772|-16.849|0.3998
72542490|NCT00106028|144614705|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.352||||0.1592||95.0|-0.845|0.14|||ANCOVA|LS means and p-value are from ANCOVA model adjusted by baseline and fixed effects for age group, treatment and pooled center for post-baseline.||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.||0.140|-0.845|0.1592
72568357|NCT01366443|144668182|SUPERIORITY_OR_OTHER||Negative Predictive Value|0.99|||||TWO_SIDED|95.0|0.94|1.0|||||"The calculation for the Wilson CI is computed using the cii (confidence interval immediate) command in Stata version 11.2, with the Wilson option."|Negative Predictive Value = true negatives/(true negatives + false negatives); It indicates how likely it is that someone with a negative test result will actually not have the characteristic.||1.00|0.94|
72403763|NCT03792672|144313714|SUPERIORITY||LSM difference|7.36|STANDARD_ERROR_OF_MEAN|6.41||0.258|TWO_SIDED|90.0|-3.44|18.2||Based on mixed model analysis, with treatment, period, sequence, treatment-by-period interaction as fixed factors, participant within sequence as a random factor, baseline as a covariate.|Mixed Models Analysis|||LICI 200 ms peak-to-peak amplitude||18.2|-3.44|0.2580
72403764|NCT03792672|144313714|SUPERIORITY||LSM difference|9.36|STANDARD_ERROR_OF_MEAN|6.41||0.1524|TWO_SIDED|90.0|-1.45|20.2|||Mixed Models Analysis|||LICI 200 ms peak-to-peak amplitude||20.2|-1.45|0.1524
72403765|NCT03792672|144313714|SUPERIORITY||LSM difference|17.2|STANDARD_ERROR_OF_MEAN|7.21||0.022|TWO_SIDED|90.0|5.06|29.4||Based on mixed model analysis, with treatment, period, sequence, treatment-by-period interaction as fixed factors, participant within sequence as a random factor, baseline as a covariate.|Mixed Models Analysis|||LICI 300 ms peak-to-peak amplitude||29.4|5.06|0.0220
72403766|NCT03792672|144313714|SUPERIORITY||LSM difference|9.58|STANDARD_ERROR_OF_MEAN|7.23||0.1927|TWO_SIDED|90.0|-2.59|21.8||Based on mixed model analysis, with treatment, period, sequence, treatment-by-period interaction as fixed factors, participant within sequence as a random factor, baseline as a covariate.|Mixed Models Analysis|||LICI 300 ms peak-to-peak amplitude||21.8|-2.59|0.1927
72403767|NCT03792672|144313715|SUPERIORITY||LSM difference|-5.65|STANDARD_ERROR_OF_MEAN|9.59||0.559|TWO_SIDED|90.0|-21.8|10.5||Based on mixed model analysis, with treatment, period, sequence, treatment-by-period interaction as fixed factors, participant within sequence as a random factor, baseline as a covariate.|Mixed Models Analysis|||SICI 2 ms peak-to-peak amplitude||10.5|-21.8|0.5590
72403768|NCT03792672|144313715|SUPERIORITY||LSM difference|-16.1|STANDARD_ERROR_OF_MEAN|9.72||0.1049|TWO_SIDED|90.0|-32.5|0.242|||Mixed Models Analysis|||SICI 2 ms peak-to-peak amplitude||0.242|-32.5|0.1049
72568358|NCT00369382|144668185|SUPERIORITY_OR_OTHER|||||||0.004|TWO_SIDED|||||two-sided alpha = 0.05|ANCOVA|Analysis of covariance (ANCOVA) with baseline creatinine clearance (Cockcroft-Gault) as a covariate and treatment group and center as factors||Change from baseline to Week 52||||0.004
72568359|NCT00369382|144668187|SUPERIORITY_OR_OTHER|||||||0.018|TWO_SIDED|||||alpha is unadjusted|ANCOVA|ANCOVA with baseline creatinine clearance (Cockcroft-Gault) as a covariate and treatment group and center as factors||Change from baseline to Week 4||||0.018
72568360|NCT00369382|144668187|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||alpha is unadjusted|ANCOVA|ANCOVA with baseline creatinine clearance (Cockcroft-Gault) as a covariate and treatment group and center as factors||Change from baseline to Week 16||||<.001
72568361|NCT00369382|144668187|SUPERIORITY_OR_OTHER|||||||0.012|TWO_SIDED|||||alpha is unadjusted|ANCOVA|ANCOVA with baseline creatinine clearance (Cockcroft-Gault) as a covariate and treatment group and center as factors||Change from baseline to Week 24||||0.012
72568362|NCT00369382|144668187|SUPERIORITY_OR_OTHER|||||||0.072|TWO_SIDED|||||alpha is unadjusted|ANCOVA|ANCOVA with baseline creatinine clearance (Cockcroft-Gault) as a covariate and treatment group and center as factors||Change from baseline to Week 32||||0.072
72568363|NCT00369382|144668187|SUPERIORITY_OR_OTHER|||||||0.175|TWO_SIDED|||||alpha is unadjusted|ANCOVA|ANCOVA with baseline creatinine clearance (Cockcroft-Gault) as a covariate and treatment group and center as factors||Change from baseline to Week 40||||0.175
72568364|NCT00369382|144668188|SUPERIORITY_OR_OTHER|||||||0.031|TWO_SIDED|||||alpha is unadjusted|ANCOVA|ANCOVA with baseline creatinine clearance (MDRD) as a covariate and treatment group and center as factors||Change from baseline to Week 4||||0.031
72568365|NCT00369382|144668188|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||alpha is unadjusted|ANCOVA|ANCOVA with baseline creatinine clearance (MDRD) as a covariate and treatment group and center as factors||Change from baseline to Week 16||||<0.001
72568366|NCT00369382|144668188|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED|||||alpha is unadjusted|ANCOVA|ANCOVA with baseline creatinine clearance (MDRD) as a covariate and treatment group and center as factors||Change from baseline to Week 24||||0.020
72568367|NCT00369382|144668188|SUPERIORITY_OR_OTHER|||||||0.151|TWO_SIDED|||||alpha is unadjusted|ANCOVA|ANCOVA with baseline creatinine clearance (MDRD) as a covariate and treatment group and center as factors||Change from baseline to Week 32||||0.151
72568368|NCT00369382|144668188|SUPERIORITY_OR_OTHER|||||||0.295|TWO_SIDED|||||alpha is unadjusted|ANCOVA|ANCOVA with baseline creatinine clearance (MDRD) as a covariate and treatment group and center as factors||Change from baseline to Week 40||||0.295
72568369|NCT00369382|144668188|SUPERIORITY_OR_OTHER|||||||0.01|TWO_SIDED|||||alpha is unadjusted|ANCOVA|ANCOVA with baseline creatinine clearance (MDRD) as a covariate and treatment group and center as factors||Change from baseline to Week 52||||0.010
72403769|NCT03792672|144313715|SUPERIORITY||LSM difference|-16.7|STANDARD_ERROR_OF_MEAN|13.5||0.2238|TWO_SIDED|90.0|-39.4|6.06||Based on mixed model analysis, with treatment, period, sequence, treatment-by-period interaction as fixed factors, participant within sequence as a random factor, baseline as a covariate.|Mixed Models Analysis|||SICI 5 ms peak-to-peak amplitude||6.06|-39.4|0.2238
72403770|NCT03792672|144313715|SUPERIORITY||LSM difference|-18.3|STANDARD_ERROR_OF_MEAN|13.6||0.1847|TWO_SIDED|90.0|-41.3|4.56|||Mixed Models Analysis|||SICI 5 ms peak-to-peak amplitude||4.56|-41.3|0.1847
72403771|NCT04534764|144313732|NON_INFERIORITY|The non-inferiority of the Test lens relative to the Control will be concluded if the upper confidence limit of LSM difference is below the non-inferiority margin 0.05 logMAR.|Least Square Mean Difference|-0.016|STANDARD_ERROR_OF_MEAN|0.0114|||TWO_SIDED|95.0|-0.039|0.006|||Mixed Models Analysis||LS Mean difference was calculated as Test - Control.|High Luminance Low Contrast||0.006|-0.039|
72403772|NCT04534764|144313732|NON_INFERIORITY|The non-inferiority of the Test lens relative to the Control will be concluded if the upper confidence limit of LSM difference is below the non-inferiority margin 0.05 logMAR.|Least Square Mean Difference|0.009|STANDARD_ERROR_OF_MEAN|0.0114|||TWO_SIDED|95.0|-0.014|0.031|||Mixed Models Analysis||LS Mean difference was calculated as Test - Control.|Low Luminance High Contrast||0.031|-0.014|
72403773|NCT03583996|144313733|OTHER||Negative Likelihood Ratio (NLR)|0.293|||||TWO_SIDED|95.0|0.097|0.882||||||The performance goal for validation of DSI ≤18.3 was the upper limit of the confidence interval (CI) for negative likelihood ratio (NLR) to rule out an NLR of \>0.52. For the null and alternate hypotheses, the upper limit of the 95% CI was NLR \>0.52 and the upper limit of the 95% CI was NLR \<=0.52, respectively. The confidence level for the CI was adjusted to maintain a 1-sided type I error rate of 0.025.||0.882|0.097|
72568370|NCT00369382|144668190|SUPERIORITY_OR_OTHER|||||||0.009|TWO_SIDED|||||alpha is unadjusted|ANCOVA|ANCOVA with baseline serum creatinine as a covariate and treatment group and center as factors||Change from baseline to Week 4||||0.009
72568371|NCT00369382|144668190|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||alpha is unadjusted|ANCOVA|ANCOVA with baseline serum creatinine as a covariate and treatment group and center as factors||Change from baseline to Week 16||||<0.001
72568372|NCT00369382|144668190|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED|||||alpha is unadjusted|ANCOVA|ANCOVA with baseline serum creatinine as a covariate and treatment group and center as factors||Change from baseline to Week 24||||0.002
72568373|NCT00369382|144668190|SUPERIORITY_OR_OTHER|||||||0.03|TWO_SIDED|||||alpha is unadjusted|ANCOVA|ANCOVA with baseline serum creatinine as a covariate and treatment group and center as factors||Change from baseline to Week 32||||0.030
72568374|NCT00369382|144668190|SUPERIORITY_OR_OTHER|||||||0.121|TWO_SIDED|||||alpha is unadjusted|ANCOVA|ANCOVA with baseline serum creatinine as a covariate and treatment group and center as factors||Change from baseline to Week 40||||0.121
72568375|NCT00369382|144668190|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED|||||alpha is unadjusted|ANCOVA|ANCOVA with baseline serum creatinine as a covariate and treatment group and center as factors||Change from baseline to Week 52||||0.001
72403774|NCT03583996|144313733|OTHER||Sensitivity|0.917|||||TWO_SIDED|95.0|0.775|0.982||||||The performance goal for validation of DSI \<= 18.3 was the observed sensitivity must have been \>0.85. The confidence level for the confidence interval (CI) was adjusted to maintain a 1-sided type I error rate of 0.025.||0.982|0.775|
72403775|NCT03583996|144313734|OTHER||Odds Ratio (OR)|1.094|||<|0.0001|TWO_SIDED|95.0|1.047|1.143||The odds ratio was for a 1-unit increase in DSI based on continuous DSI.|Regression, Logistic|Unadjusted (no covariates)||||1.143|1.047|<0.0001
72403776|NCT03583996|144313734|OTHER||Odds Ratio (OR)|1.109|||<|0.0001|TWO_SIDED|95.0|1.058|1.163|||Regression, Logistic|Adjusted for demographic covariates, including age, race, sex, BMI, and ethnicity.||||1.163|1.058|<0.0001
72403777|NCT03583996|144313734|OTHER||Odds Ratio (OR)|1.092|||<|0.001|TWO_SIDED|95.0|1.041|1.145|||Regression, Logistic|Adjusted for severity of liver disease covariates, compensated cirrhosis (CP class A)||||1.145|1.041|<0.001
72403778|NCT03583996|144313734|OTHER||Odds Ratio (OR)|1.089|||<|0.001|TWO_SIDED|95.0|1.038|1.142|||Regression, Logistic|Adjusted for severity of liver disease covariates, decompensated cirrhosis (CP class B)||||1.142|1.038|<0.001
72568376|NCT00369382|144668192|SUPERIORITY_OR_OTHER||slope difference (CNI - SRL)|-2.311||||0.126|TWO_SIDED|95.0|-5.282|0.66||alpha is unadjusted|Random coefficient model||Random coefficient model with each participant's creatinine clearance function of time on treatment; intra-subject regression coefficients considered random.|||0.660|-5.282|0.126
72568377|NCT00369382|144668194|SUPERIORITY_OR_OTHER|||||||0.206|TWO_SIDED|||||alpha is unadjusted|Fisher Exact|||For-cause Biopsy-Confirmed Acute Rejection compared between treatment groups||||0.206
72568378|NCT00369382|144668194|SUPERIORITY_OR_OTHER|||||||0.476|TWO_SIDED|||||alpha is unadjusted|Fisher Exact|||Standard of Care Biopsy-Confirmed Acute Rejection compared between treatment groups||||0.476
72403779|NCT03161483|144313735|SUPERIORITY||Stratified difference|11.4||||0.214|TWO_SIDED|95.0|-6.57|29.0|||Cochran-Mantel-Haenszel|||||29.00|-6.57|0.214
72403780|NCT03161483|144313735|SUPERIORITY||Stratified difference|5.0||||0.512|TWO_SIDED|95.0|-9.77|19.48|||Cochran-Mantel-Haenszel|||||19.48|-9.77|0.512
72403781|NCT03161483|144313735|SUPERIORITY||Stratified difference|19.4||||0.011|TWO_SIDED|95.0|4.12|33.42|||Cochran-Mantel-Haenszel|||||33.42|4.12|0.011
72403782|NCT03161483|144313736|SUPERIORITY||Stratified difference|10.3||||0.264|TWO_SIDED|95.0|-7.66|27.97|||Cochran-Mantel-Haenszel|||||27.97|-7.66|0.264
72403783|NCT03161483|144313736|SUPERIORITY||Stratified difference|6.5||||0.399|TWO_SIDED|95.0|-8.45|21.0|||Cochran-Mantel-Haenszel|||||21.00|-8.45|0.399
72403784|NCT03161483|144313736|SUPERIORITY||Stratified difference|19.3||||0.012|TWO_SIDED|95.0|4.01|33.36|||Cochran-Mantel-Haenszel|||||33.36|4.01|0.012
72403785|NCT03161483|144313737|SUPERIORITY||Stratified difference|24.0||||0.446|TWO_SIDED|95.0|-12.38|53.11|||Cochran-Mantel-Haenszel|||||53.11|-12.38|0.446
72568379|NCT00507546|144668200|SUPERIORITY_OR_OTHER|||||||0.7|TWO_SIDED|95.0|||||Friedman|||||||0.70
72568380|NCT00507546|144668201|SUPERIORITY_OR_OTHER|||||||0.35||95.0|||||Friedman|||||||0.35
72568381|NCT01673698|144668202|SUPERIORITY_OR_OTHER|||||||0.0041|TWO_SIDED||||||t-test, 1 sided|||||||0.0041
72568382|NCT01673698|144668203|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||t-test, 1 sided|||||||<0.0001
72568383|NCT01673698|144668204|SUPERIORITY_OR_OTHER|||||||0.561|TWO_SIDED||||||Chi-squared|||||||0.5610
72568384|NCT00609466|144668221|SUPERIORITY_OR_OTHER||Least square mean|70.8|||<|0.0001||95.0|35.9|105.6||No multiplicity adjustment used.|ANCOVA|ANCOVA with treatment and centre as fixed effects and baseline pain as covariate.||Null hypothesis of no treatment difference.||105.6|35.9|<0.0001
72568385|NCT00609466|144668222|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Test for time (in hours) to first rescue medication use. No multiplicity adjustment.|Log Rank|Adjusted for site||||||<0.0001
72568386|NCT00609466|144668223|SUPERIORITY_OR_OTHER||Least square mean|37.5|||<|0.0001||95.0|22.7|52.2||No multiplicity adjustment used|ANCOVA|ANCOVA with treatment and centre as fixed effects and baseline pain as covariate.||Null hypothesis of no treatment difference.||52.2|22.7|<0.0001
72568387|NCT00609466|144668224|SUPERIORITY_OR_OTHER||Least square means|9.9|||<|0.0001||95.0|6.2|13.6||No multiplicity adjustment used.|ANCOVA|ANCOVA with treatment and centre as fixed effects and baseline pain as covariate.||Null hypothesis of no treatment difference.||13.6|6.2|<0.0001
72568388|NCT00609466|144668225|SUPERIORITY_OR_OTHER||Least square mean|20.6|||<|0.0001||95.0|13.2|28.0||No multiplicity adjustment used.|ANCOVA|ANCOVA with treatment and centre as fixed effects and baseline pain as covariate.||Null hypothesis of no treatment difference.||28.0|13.2|<0.0001
72568389|NCT00609466|144668226|SUPERIORITY_OR_OTHER||Least square mean|36.4|||<|0.0001||95.0|20.7|52.0||No multiplicity adjustment used.|ANCOVA|ANCOVA with treatment and centre as fixed effects and baseline pain as covariate.||Null hypothesis of no treatment difference.||52.0|20.7|<0.0001
72403786|NCT03161483|144313737|SUPERIORITY||Stratified difference|5.3|||>|0.999|TWO_SIDED|95.0|-27.64|39.38|||Cochran-Mantel-Haenszel|||||39.38|-27.64|>0.999
72403787|NCT03161483|144313737|SUPERIORITY||Stratified difference|14.2||||0.488|TWO_SIDED|95.0|-19.54|44.48|||Cochran-Mantel-Haenszel|||||44.48|-19.54|0.488
72403788|NCT03161483|144313738|SUPERIORITY||Stratified difference|12.4||||0.092|TWO_SIDED|95.0|-2.74|24.07|||Cochran-Mantel-Haenszel|||||24.07|-2.74|0.092
72403789|NCT03161483|144313738|SUPERIORITY||Stratified difference|-5.3||||0.434|TWO_SIDED|95.0|-18.43|8.06|||Cochran-Mantel-Haenszel|||||8.06|-18.43|0.434
72403790|NCT03161483|144313738|SUPERIORITY||Stratified difference|8.0||||0.182|TWO_SIDED|95.0|-3.88|19.65|||Cochran-Mantel-Haenszel|||||19.65|-3.88|0.182
72403791|NCT03161483|144313739|SUPERIORITY||Stratified difference|12.1||||0.098|TWO_SIDED|95.0|-2.98|23.78|||Cochran-Mantel-Haenszel|||||23.78|-2.98|0.098
72403792|NCT03161483|144313739|SUPERIORITY||Stratified difference|-4.3||||0.521|TWO_SIDED|95.0|-17.36|8.92|||Cochran-Mantel-Haenszel|||||8.92|-17.36|0.521
72403793|NCT03161483|144313739|SUPERIORITY||Stratified difference|6.8||||0.267|TWO_SIDED|95.0|-5.24|18.55|||Cochran-Mantel-Haenszel|||||18.55|-5.24|0.267
72403794|NCT03161483|144313740|SUPERIORITY||Difference in adjusted mean|0.7||||0.116|TWO_SIDED|95.0|-0.2|1.5|||longitudinal data analysis model|||||1.5|-0.2|0.116
72403795|NCT03161483|144313740|SUPERIORITY||Difference in adjusted mean|0.7||||0.094|TWO_SIDED|95.0|-0.1|1.6|||longitudinal data analysis model|||||1.6|-0.1|0.094
72403796|NCT03161483|144313740|SUPERIORITY||Difference in adjusted mean|0.1||||0.881|TWO_SIDED|95.0|-0.6|0.8|||longitudinal data analysis model|||||0.8|-0.6|0.881
72403797|NCT03161483|144313741|SUPERIORITY||Difference in adjusted mean|1.1||||0.16|TWO_SIDED|95.0|-0.4|2.6|||longitudinal data analysis model|||||2.6|-0.4|0.160
72403798|NCT03161483|144313741|SUPERIORITY||Difference in adjusted mean|1.3||||0.056|TWO_SIDED|95.0|0.0|2.6|||longitudinal data analysis model|||||2.6|0.0|0.056
72403799|NCT03161483|144313741|SUPERIORITY||Difference in adjusted mean|0.3||||0.621|TWO_SIDED|95.0|-1.0|1.6|||longitudinal data analysis model|||||1.6|-1.0|0.621
72568390|NCT00609466|144668227|SUPERIORITY_OR_OTHER||Least square means|108.2||||0.0002||95.0|51.9|164.5||No multiplicity adjustment used.|ANCOVA|ANCOVA with treatment and centre as fixed effects and baseline pain as covariate.||Null hypothesis of no treatment difference.||164.5|51.9|0.0002
72568391|NCT01195272|144668243|SUPERIORITY_OR_OTHER|||||||0.308|||||||t-test, 2 sided|||4 hrs: Visit 3 versus Visit 2||||0.308
72403800|NCT03161483|144313743|SUPERIORITY||Difference in adjusted mean|-1.1||||0.546|TWO_SIDED|95.0|-4.7|2.5|||longitudinal data analysis model|||||2.5|-4.7|0.546
72403801|NCT03161483|144313743|SUPERIORITY||Difference in adjusted mean|-0.6||||0.681|TWO_SIDED|95.0|-3.7|2.4|||longitudinal data analysis model|||||2.4|-3.7|0.681
72403802|NCT03161483|144313743|SUPERIORITY||Difference in adjusted mean|1.4||||0.35|TWO_SIDED|95.0|-1.6|4.4|||longitudinal data analysis model|||||4.4|-1.6|0.350
72403803|NCT03161483|144313744|SUPERIORITY|\<= 7.5 mg/day|Stratified difference|0.2|||>|0.999|TWO_SIDED|95.0|-15.13|15.91|||longitudinal data analysis model|||||15.91|-15.13|>0.999
72403804|NCT03161483|144313744|SUPERIORITY|\< 10 mg/day|Stratified difference|-3.2|||>|0.999|TWO_SIDED|95.0|-17.74|13.0|||longitudinal data analysis model|||||13.00|-17.74|>0.999
72403805|NCT03161483|144313745|SUPERIORITY||Difference in adjusted means|2.8||||0.535|TWO_SIDED|95.0|-6.0|11.6|||longitudinal data analysis model|||||11.6|-6.0|0.535
72403806|NCT03161483|144313745|SUPERIORITY||Difference in adjusted means|4.2||||0.309|TWO_SIDED|95.0|-3.9|12.2|||longitudinal data analysis model|||||12.2|-3.9|0.309
72403807|NCT03161483|144313745|SUPERIORITY||Difference in adjusted means|6.5||||0.091|TWO_SIDED|95.0|-1.0|14.1|||longitudinal data analysis model|||||14.1|-1.0|0.091
72403808|NCT05389657|144313774|SUPERIORITY||Odds Ratio (OR)|0.617||||0.47|TWO_SIDED|95.0|0.167|2.283|||Regression, Logistic|multilevel logistic regression||We used logistic multilevel models to examine the impact of training assignment (reference = live training) on training completion, with a random intercept at the agency level. Covariates included prior level of training and/or experience in FBT, attitudes towards evidence-based practice (MPAS), perceived importance of eating disorder treatment to organization, and training preference.||2.283|0.167|0.47
72403809|NCT05389657|144313775|SUPERIORITY||adjusted group difference unstandardized|-1.268||||0.29|TWO_SIDED|95.0|-3.618|1.083|||Regression, Linear|multilevel linear regression with restricted maximum likelihood (REML) estimation||We used linear multilevel models with restricted maximum likelihood (REML) estimation to examine the impact of training assignment (reference = live training) on knowledge acquisition at post-training, with a random intercept at the agency level. Covariates included baseline FBT-KA score, prior level of training and/or experience in FBT, attitudes towards evidence-based practice (MPAS), perceived importance of eating disorder treatment to organization, and training preference.||1.083|-3.618|.29
72403810|NCT05389657|144313776|SUPERIORITY||Odds Ratio (OR)|1.16||||0.92|TWO_SIDED|95.0|0.07|19.293|||Regression, Logistic|multilevel logistic regression||We used logistic multilevel models to examine the impact of training assignment (reference = live training) on engagement in FBT consultation at 12 months, with a random intercept at the agency level. Covariates included baseline intent to seek FBT consultation, prior level of training and/or experience in FBT, attitudes towards evidence-based practice (MPAS), perceived importance of eating disorder treatment to organization, and training preference.||19.293|0.070|0.92
72403811|NCT01907828|144313777|OTHER|||||||0.22|||||||Log Rank|||Kaplan-Meier analysis performed to provide freedom from atrial fibrillation rates at one year for each randomization arm using date of ablation procedure to date of first event.||||0.22
72403812|NCT01907828|144313781|SUPERIORITY|||||||0.2766|||||||Paired Student's t-test|||||||0.2766
72403813|NCT01907828|144313782|SUPERIORITY|||||||0.7663|||||||Wilcoxon signed-rank test|||||||0.7663
72403814|NCT01907828|144313785|SUPERIORITY||Mean Difference (Final Values)|-5.86|STANDARD_DEVIATION|15.21||0.0849|TWO_SIDED|95.0|-12.61|0.88|||Paired Student's t-test|||Change in ASBP at 12 months||0.88|-12.61|0.0849
72403815|NCT01907828|144313785|SUPERIORITY||Mean Difference (Final Values)|-5.82|STANDARD_DEVIATION|7.45||0.0014|TWO_SIDED|95.0|-9.12|-2.52|||Paired Student's t-test|||Change in ADBP at 12 months||-2.52|-9.12|0.0014
72568392|NCT01195272|144668243|SUPERIORITY_OR_OTHER|||||||0.415|||||||t-test, 2 sided|||4 hrs: Visit 5 versus Visit 2||||0.415
72568393|NCT01195272|144668243|SUPERIORITY_OR_OTHER|||||||0.335|||||||t-test, 2 sided|||4 hrs: Visit 5 versus Visit 3||||0.335
72488294|NCT01431274|144505147|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.014|STANDARD_ERROR_OF_MEAN|0.012||0.2401|TWO_SIDED|95.0|-0.01|0.038||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (2.5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within-patient errors."|||0.038|-0.010|0.2401
72488295|NCT01431274|144505147|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.009|STANDARD_ERROR_OF_MEAN|0.012||0.4601|TWO_SIDED|95.0|-0.033|0.015||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.015|-0.033|0.4601
72488296|NCT01431274|144505148|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.088|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|0.064|0.112||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within-patient errors."|||0.112|0.064|<0.0001
72488297|NCT01431274|144505148|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.076|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|0.052|0.1||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Tiotropium (5 μg).~Spatial power covariance structure for within-patient errors."|||0.100|0.052|<0.0001
72488298|NCT01431274|144505148|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.07|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|0.046|0.094||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within-patient errors."|||0.094|0.046|<0.0001
72488299|NCT01431274|144505148|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.051|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|0.027|0.075||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.075|0.027|<0.0001
72488300|NCT01431274|144505148|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.058|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|0.034|0.082||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (5 µg).~Spatial power covariance structure for within-patient errors."|||0.082|0.034|<0.0001
72488301|NCT01431274|144505148|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.018|STANDARD_ERROR_OF_MEAN|0.012||0.1405|TWO_SIDED|95.0|-0.006|0.042||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tio+Olo FDC (2.5/5 µg).~Spatial power covariance structure for within-patient errors."|||0.042|-0.006|0.1405
72515379|NCT00589979|144561509|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.18||||0.9108||95.0|-19.8|22.2||All statistical tests were 2-sided with a significance level of alpha=0.05.|Linear mixed effects models||The results are reported as least squares means and their differences along with associated P-values, and 95% confidence intervals for each fixed effect in the model.|Effectiveness: the overall treatment difference for Lidoderm and placebo patch was compared by combining data for patients receiving the respective treatment regardless of randomized study sequence. The endpoint was analyzed by linear mixed effects models incorporating treatment, period, sequence, and first-order carryover as fixed effects, and patient nested within sequence as a random effect. P-value for the random effect (s2) is from the Wald Z-test for the covariance parameter estimates.||22.2|-19.8|0.9108
72568394|NCT01195272|144668243|SUPERIORITY_OR_OTHER|||||||0.12|||||||t-test, 2 sided|||4 hrs: Visit 8 versus Visit 2||||0.120
72488302|NCT01431274|144505148|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.069|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|0.045|0.093||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.093|0.045|<0.0001
72568395|NCT01195272|144668243|SUPERIORITY_OR_OTHER|||||||0.061|||||||t-test, 2 sided|||4 hrs: Visit 8 versus Visit 3||||0.061
72568396|NCT01195272|144668243|SUPERIORITY_OR_OTHER|||||||0.031|||||||t-test, 2 sided|||4 hrs: Visit 8 versus Visit 5||||0.031
72568397|NCT01195272|144668243|SUPERIORITY_OR_OTHER|||||||0.131|||||||t-test, 2 sided|||20 hrs: Visit 3 versus Visit 2||||0.131
72515380|NCT00589979|144561509|SUPERIORITY_OR_OTHER||Mean Difference (Net)|8.31||||0.3769||95.0|-10.3|27.0||All statistical tests were 2-sided with a significance level of alpha=0.05.|Linear mixed effects models||The results are reported as least squares means and their differences along with associated P-values, and 95% confidence intervals for each fixed effect in the model.|Supplementation: the overall treatment difference for Lidoderm and placebo patch was compared by combining data for patients receiving the respective treatment regardless of randomized study sequence. The endpoint was analyzed by linear mixed effects models incorporating treatment, period, sequence, and first-order carryover as fixed effects, and patient nested within sequence as a random effect. P-value for the random effect (s2) is from the Wald Z-test for the covariance parameter estimates.||27.0|-10.3|0.3769
72515381|NCT01397448|144561516|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.11|||<|0.001|TWO_SIDED|95.0|0.04|0.31|||Log Rank|||||0.31|0.04|<0.001
72515382|NCT01397448|144561516|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.05|||<|0.001|TWO_SIDED|95.0|0.01|0.23|||Log Rank|||||0.23|0.01|<0.001
72515383|NCT02180217|144561519|OTHER||Odds Ratio (OR)|13.71|||<|0.001|TWO_SIDED|95.0|3.73|53.44|||Cochran-Mantel-Haenszel|||||53.44|3.73|<.001
72515384|NCT04390568|144561556|OTHER|The basic model used for the investigation of dose proportionality was a power model (regression model applied to log-transformed data) that described the functional relationship between the dose and the area under the concentration-time curve of Spesolimap in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) of the intravenous dose groups.|Slope|1.123|STANDARD_ERROR_OF_MEAN|0.085|||TWO_SIDED|90.0|0.979|1.268|||||Based on the estimate for slope parameter (β), a 2-sided 90% confidence interval (CI) for the slope was computed. Standard error of the mean is actually standard error of slope.|No statistical hypotheses tests were planned for this trial.||1.268|0.979|
72515385|NCT04390568|144561557|OTHER|The basic model used for the investigation of dose proportionality was a power model (regression model applied to log-transformed data) that described the functional relationship between the dose and the maximum measured concentration of the Spesolimap in plasma (Cmax) of the intravenous dose groups.|Slope|1.072|STANDARD_ERROR_OF_MEAN|0.065|||TWO_SIDED|90.0|0.961|1.183|||||Based on the estimate for slope parameter (β), a 2-sided 90% confidence interval (CI) for the slope was computed. Standard error of the mean is actually standard error of slope.|No statistical hypotheses tests were planned for this trial.||1.183|0.961|
72515386|NCT03784027|144561561|SUPERIORITY||Mean Difference (Final Values)|8.7|||<|0.001|TWO_SIDED|95.0|7.4|9.9|||Regression, Linear||The mean adjusted differences are based on a linear mixed model with adjustment for repeated participant measures, with period as a fixed effect and trial site as a random effect; the model also accounted for the baseline values.|||9.9|7.4|<0.001
72515387|NCT03784027|144561562|SUPERIORITY||Mean Difference (Final Values)|-8.5|||<|0.001|TWO_SIDED|95.0|-9.9|-7.1||The primary and key secondary end points were tested in hierarchy (Time in range, time \>180mg/dL, HbA1c, mean glucose, time \<70mg/dL) to control the type 1 error with the use of the fixed-sequence method.|Regression, Linear||The mean adjusted differences are based on a linear mixed model with adjustment for repeated participant measures, with period as a fixed effect and trial site as a random effect; the model also accounted for the baseline values.|||-7.1|-9.9|<0.001
72515388|NCT03784027|144561563|SUPERIORITY||Mean Difference (Final Values)|-0.4|||<|0.001|TWO_SIDED|95.0|-0.5|-0.3||The primary and key secondary end points were tested in hierarchy (Time in range, time \>180mg/dL, HbA1c, mean glucose, time \<70mg/dL) to control the type 1 error with the use of the fixed-sequence method.|Regression, Linear||The mean adjusted differences are based on a linear mixed model with adjustment for repeated participant measures, with period as a fixed effect and trial site as a random effect; the model also accounted for the baseline values.|||-0.3|-0.5|<0.001
72515389|NCT03784027|144561564|SUPERIORITY||Mean Difference (Final Values)|-3.9|||<|0.001|TWO_SIDED|95.0|-4.9|-2.9|||Mixed Models Analysis|||||-2.9|-4.9|<0.001
72568398|NCT01195272|144668243|SUPERIORITY_OR_OTHER|||||||0.202|||||||t-test, 2 sided|||20 hrs: Visit 5 versus Visit 2||||0.202
72568399|NCT01195272|144668243|SUPERIORITY_OR_OTHER|||||||0.484|||||||t-test, 2 sided|||20 hrs: Visit 5 versus Visit 3||||0.484
72515390|NCT03784027|144561565|SUPERIORITY||Mean Difference (Final Values)|-12.3|||<|0.001|TWO_SIDED|95.0|-14.8|-9.8||The primary and key secondary end points were tested in hierarchy (Time in range, time \>180mg/dL, HbA1c, mean glucose, time \<70mg/dL) to control the type 1 error with the use of the fixed-sequence method.|Regression, Linear||The mean adjusted differences are based on a linear mixed model with adjustment for repeated participant measures, with period as a fixed effect and trial site as a random effect; the model also accounted for the baseline values.|||-9.8|-14.8|<0.001
72515391|NCT03784027|144561566|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.74|TWO_SIDED|95.0|-0.4|0.5||The primary and key secondary end points were tested in hierarchy (Time in range, time \>180mg/dL, HbA1c, mean glucose, time \<70mg/dL) to control the type 1 error with the use of the fixed-sequence method.|Regression, Linear|||||0.5|-0.4|0.74
72568400|NCT01195272|144668243|SUPERIORITY_OR_OTHER|||||||0.047|||||||t-test, 2 sided|||20 hrs: Visit 8 versus Visit 2||||0.047
72568401|NCT01195272|144668243|SUPERIORITY_OR_OTHER|||||||0.285|||||||t-test, 2 sided|||20 hrs: Visit 8 versus Visit 3||||0.285
72568402|NCT01195272|144668243|SUPERIORITY_OR_OTHER|||||||0.315|||||||t-test, 2 sided|||20 hrs: Visit 8 versus Visit 5||||0.315
72568403|NCT01195272|144668244|SUPERIORITY_OR_OTHER|||||||0.288|||||||t-test, 2 sided|||4 hrs: Visit 3 versus Visit 2||||0.288
72568404|NCT01195272|144668244|SUPERIORITY_OR_OTHER|||||||0.318|||||||t-test, 2 sided|||4 hrs: Visit 5 versus Visit 2||||0.318
72568405|NCT01195272|144668244|SUPERIORITY_OR_OTHER|||||||0.4|||||||t-test, 2 sided|||4 hrs: Visit 5 versus Visit 3||||0.400
72568406|NCT01195272|144668244|SUPERIORITY_OR_OTHER|||||||0.317|||||||t-test, 2 sided|||4 hrs: Visit 8 versus Visit 2||||0.317
72403816|NCT01907828|144313785|SUPERIORITY||Mean Difference (Final Values)|-3.07|STANDARD_DEVIATION|19.21||0.5599|TWO_SIDED|95.0|-14.16|8.02|||Paired Student's t-test|||Change in ASBP at 12 months.||8.02|-14.16|0.5599
72403817|NCT01907828|144313785|SUPERIORITY||Mean Difference (Final Values)|-8.43|STANDARD_DEVIATION|9.42||0.0052|TWO_SIDED|95.0|-13.87|-2.99|||Paired Student's t-test|||Change in ADBP at 12 months||-2.99|-13.87|0.0052
72403818|NCT01907828|144313786|SUPERIORITY||Mean Difference (Final Values)|-5.71|STANDARD_DEVIATION|14.84||0.1326|TWO_SIDED|95.0|-13.34|1.93|||Paired Student's t-test|||Change in ASBP at 24 months||1.93|-13.34|0.1326
72403819|NCT01907828|144313786|SUPERIORITY||Mean Difference (Final Values)|-6.94|STANDARD_DEVIATION|6.06||0.0002|TWO_SIDED|95.0|-10.06|-3.83|||Paired Student's t-test|||Change in ADBP at 24 months||-3.83|-10.06|0.0002
72488303|NCT01431274|144505148|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.012|STANDARD_ERROR_OF_MEAN|0.012||0.3118|TWO_SIDED|95.0|-0.012|0.036||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within-patient errors."|||0.036|-0.012|0.3118
72488304|NCT01431274|144505148|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.019|STANDARD_ERROR_OF_MEAN|0.012||0.1171|TWO_SIDED|95.0|-0.005|0.043||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (2.5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within-patient errors."|||0.043|-0.005|0.1171
72488305|NCT01431274|144505148|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.007|STANDARD_ERROR_OF_MEAN|0.012||0.5759|TWO_SIDED|95.0|-0.031|0.017||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.017|-0.031|0.5759
72515392|NCT03784027|144561567|SUPERIORITY|The mean adjusted differences are based on a linear mixed model with adjustment for repeated participant measures, with period as a fixed effect and trial site as a random effect; the model also accounted for the baseline values.|Mean Difference (Final Values)|-6.2|||||TWO_SIDED|95.0|-7.6|-4.8|||||Confidence intervals for the secondary end points were adjusted for multiple comparisons with the use of the Benjamini-Hochberg procedure to control the false discovery rate.|||-4.8|-7.6|
72568407|NCT01195272|144668244|SUPERIORITY_OR_OTHER|||||||0.137|||||||t-test, 2 sided|||4 hrs: Visit 8 versus Visit 3||||0.137
72403820|NCT01907828|144313786|SUPERIORITY||Mean Difference (Final Values)|-8.58|STANDARD_DEVIATION|12.41||0.0354|TWO_SIDED|95.0|-16.47|-0.7|||Paired Student's t-test|||Change in ASBP at 24 months||-0.70|-16.47|0.0354
72403821|NCT01907828|144313786|SUPERIORITY||Mean Difference (Final Values)|-10.33|STANDARD_DEVIATION|8.53||0.0015|TWO_SIDED|95.0|-15.75|-4.91|||Paired Student's t-test|||Change in ADBP at 24 months||-4.91|-15.75|0.0015
72403822|NCT01907828|144313787|SUPERIORITY||Mean Difference (Final Values)|2.6|STANDARD_DEVIATION|24.4||0.5399|TWO_SIDED|95.0|-6.0|11.3|||Paired Student's t-test|||Change in OSBP at 12 months.||11.3|-6.0|0.5399
72403823|NCT01907828|144313787|SUPERIORITY||Mean Difference (Final Values)|-0.4|STANDARD_DEVIATION|11.8||0.8489|TWO_SIDED|95.0|-4.6|3.8|||Paired Student's t-test|||Change in Office Diastolic Blood Pressure (ODBP) at 12 months||3.8|-4.6|0.8489
72403824|NCT01907828|144313787|SUPERIORITY|Change in Office Systolic Blood Pressure (OSBP) at 12 months.|Mean Difference (Final Values)|2.0|STANDARD_DEVIATION|30.0||0.7999|TWO_SIDED|95.0|-14.6|18.6|||Paired Student's t-test|||||18.6|-14.6|0.7999
72403825|NCT01907828|144313787|SUPERIORITY||Mean Difference (Final Values)|-5.4|STANDARD_DEVIATION|15.8||0.2076|TWO_SIDED|95.0|-14.2|3.4|||Paired Student's t-test|||Change in ODBP at 12 months||3.4|-14.2|0.2076
72403826|NCT01907828|144313788|SUPERIORITY||Mean Difference (Final Values)|0.6|STANDARD_DEVIATION|22.3||0.882|TWO_SIDED|95.0|-7.9|9.1|||Paired Student's t-test|||Change in OSBP at 24 months||9.1|-7.9|0.8820
72403827|NCT01907828|144313788|SUPERIORITY||Mean Difference (Final Values)|0.5|STANDARD_DEVIATION|11.0||0.8019|TWO_SIDED|95.0|-3.7|4.7|||Paired Student's t-test|||Change in ODBP at 24 months||4.7|-3.7|0.8019
72568408|NCT01195272|144668244|SUPERIORITY_OR_OTHER|||||||0.052|||||||t-test, 2 sided|||4 hrs: Visit 8 versus Visit 5||||0.052
72568409|NCT01195272|144668244|SUPERIORITY_OR_OTHER|||||||0.354|||||||t-test, 2 sided|||20 hrs: Visit 3 versus Visit 2||||0.354
72568410|NCT01195272|144668244|SUPERIORITY_OR_OTHER|||||||0.266|||||||t-test, 2 sided|||20 hrs: Visit 5 versus Visit 2||||0.266
72568411|NCT01195272|144668244|SUPERIORITY_OR_OTHER|||||||0.378|||||||t-test, 2 sided|||20 hrs: Visit 5 versus Visit 3||||0.378
72568412|NCT01195272|144668244|SUPERIORITY_OR_OTHER|||||||0.422|||||||t-test, 2 sided|||20 hrs: Visit 8 versus Visit 2||||0.422
72568413|NCT01195272|144668244|SUPERIORITY_OR_OTHER|||||||0.444|||||||t-test, 2 sided|||20 hrs: Visit 8 versus Visit 3||||0.444
72568414|NCT01195272|144668244|SUPERIORITY_OR_OTHER|||||||0.345|||||||t-test, 2 sided|||20 hrs: Visit 8 versus Visit 5||||0.345
72568415|NCT01195272|144668245|SUPERIORITY_OR_OTHER|||||||0.39|||||||ANOVA|||Visit 3 versus Visit 2||||0.39
72568416|NCT01195272|144668245|SUPERIORITY_OR_OTHER|||||||0.08|||||||ANOVA|||Visit 5 versus Visit 3||||0.08
72568417|NCT01195272|144668245|SUPERIORITY_OR_OTHER|||||||0.18|||||||ANOVA|||Visit 5 versus Visit 3||||0.18
72568418|NCT01195272|144668246|SUPERIORITY_OR_OTHER|||||||0.48|||||||ANOVA|||Visit 3 versus Visit 2||||0.48
72568419|NCT01195272|144668246|SUPERIORITY_OR_OTHER|||||||0.3|||||||ANOVA|||Visit 5 versus Visit 2||||0.30
72568420|NCT01195272|144668246|SUPERIORITY_OR_OTHER|||||||0.34|||||||ANOVA|||Visit 5 versus Visit 3||||0.34
72403828|NCT01907828|144313788|SUPERIORITY||Mean Difference (Final Values)|7.4|STANDARD_DEVIATION|22.9||0.2177|TWO_SIDED|95.0|-4.8|19.6|||Paired Student's t-test|||Change in OSBP at 24 months||19.6|-4.8|0.2177
72515393|NCT03784027|144561568|SUPERIORITY|The mean adjusted differences are based on a linear mixed model with adjustment for repeated participant measures, with period as a fixed effect and trial site as a random effect; the model also accounted for the baseline values. Differences in percents are shown in percentage points.|Mean Difference (Final Values)|-0.7|||||TWO_SIDED|95.0|-1.5|0.05|||||Confidence intervals for the secondary end points were adjusted for multiple comparisons with the use of the Benjamini-Hochberg procedure to control the false discovery rate.|||0.05|-1.5|
72515394|NCT03784027|144561569|SUPERIORITY||Mean Difference (Final Values)|0.02|||||TWO_SIDED|95.0|-0.1|0.1||The mean adjusted differences are based on a linear mixed model with adjustment for repeated participant measures, with period as a fixed effect and trial site as a random effect; the model also accounted for the baseline values.|||Confidence intervals for the secondary end points were adjusted for multiple comparisons with the use of the Benjamini-Hochberg procedure to control the false discovery rate.|||0.1|-0.1|
72515395|NCT03784027|144561570|SUPERIORITY|The mean adjusted differences are based on a linear mixed model with adjustment for repeated participant measures, with period as a fixed effect and trial site as a random effect; the model also accounted for the baseline values.|Mean Difference (Final Values)|-1.0|||||TWO_SIDED|95.0|-1.6|-0.6|||||Confidence intervals for the secondary end points were adjusted for multiple comparisons with the use of the Benjamini-Hochberg procedure to control the false discovery rate.|||-0.6|-1.6|
72515396|NCT03784027|144561571|NON_INFERIORITY|The mean adjusted differences are based on a linear mixed model with adjustment for repeated participant measures, with period as a fixed effect and trial site as a random effect; the model also accounted for the baseline values.|Mean Difference (Final Values)|0.002|||||TWO_SIDED|95.0|-0.006|0.009|||||Confidence intervals for the secondary end points were adjusted for multiple comparisons with the use of the Benjamini-Hochberg procedure to control the false discovery rate.|||0.009|-0.006|
72515397|NCT03784027|144561572|SUPERIORITY||Mean Difference (Final Values)|0.004||||0.75|TWO_SIDED|95.0|-0.02|0.03|||Regression, Linear|Based on a longitudinal model adjusting for baseline value and period as fixed effects. The model accounts for correlated data from the same subject.||||0.03|-0.02|0.75
72515398|NCT03784027|144561573|SUPERIORITY|The mean adjusted differences are based on a linear mixed model with adjustment for repeated participant measures, with period as a fixed effect and trial site as a random effect; the model also accounted for the baseline values.|Mean Difference (Final Values)|0.3|||||TWO_SIDED|95.0|-0.1|0.8|||||(For total daily insulin use) Confidence intervals for the secondary end points were adjusted for multiple comparisons with the use of the Benjamini-Hochberg procedure to control the false discovery rate.|||0.8|-0.1|
72515399|NCT01146951|144561583|SUPERIORITY_OR_OTHER||Hodges-Lehmann|-26.65||||0.003|TWO_SIDED|90.0|-40.3|-11.8|||Wilcoxon (Mann-Whitney)|||||-11.80|-40.30|0.003
72515400|NCT01146951|144561584|SUPERIORITY_OR_OTHER|||||||0.074|||||||Fisher's exact test|||||||0.074
72515401|NCT01146951|144561585|SUPERIORITY_OR_OTHER||Hodges-Lehmann method|-33.3|||<|0.001|TWO_SIDED|90.0|-47.1|-17.0|||Wilcoxon (Mann-Whitney)|||||-17.00|-47.10|<0.001
72515402|NCT01146951|144561586|SUPERIORITY_OR_OTHER||Hodges-Lehmann method|-57.15||||0.025|TWO_SIDED|90.0|-104.5|-17.3|||Wilcoxon (Mann-Whitney)|||Analysis for Partial Seizure Frequency||-17.30|-104.50|0.025
72515403|NCT01146951|144561586|SUPERIORITY_OR_OTHER||Hodges-Lehmann method|-28.65||||0.128|TWO_SIDED|90.0|-72.0|0.9|||Wilcoxon (Mann-Whitney)|||Analysis of atypical absence seizure frequency||0.90|-72.00|0.128
72515404|NCT01146951|144561586|SUPERIORITY_OR_OTHER||Hodges-Lehmann method|-54.35||||0.021|TWO_SIDED|90.0|-126.6|-15.4|||Wilcoxon (Mann-Whitney)|||Analysis for myoclonic seizure frequency||-15.40|-126.60|0.021
72515405|NCT01146951|144561586|SUPERIORITY_OR_OTHER||Hodges-Lehmann method|-23.2||||0.031|TWO_SIDED|90.0|-40.7|-5.6|||Wilcoxon (Mann-Whitney)|||Analysis of tonic seizure frequency||-5.60|-40.70|0.031
72515406|NCT01146951|144561586|SUPERIORITY_OR_OTHER||Hodges-Lehmann method|-71.4||||0.107|TWO_SIDED|90.0|-464.7|30.5|||Wilcoxon (Mann-Whitney)|||Analysis for Tonic-clonic seizure frequency||30.50|-464.70|0.107
72515407|NCT01146951|144561586|SUPERIORITY_OR_OTHER||Hodges-Lehmann method|-52.1||||0.221|TWO_SIDED|90.0|-89.1|10.8|||Wilcoxon (Mann-Whitney)|||Analysis of Atonic seizure frequency||10.80|-89.10|0.221
72403829|NCT01907828|144313788|SUPERIORITY||Mean Difference (Final Values)|-3.0|STANDARD_DEVIATION|15.5||0.4502|TWO_SIDED|95.0|-11.2|5.2|||Paired Student's t-test|||Change in ODBP at 24 months||5.2|-11.2|0.4502
72515408|NCT01146951|144561587|SUPERIORITY_OR_OTHER|||||||0.041|||||||Wilcoxon (Mann-Whitney)|||Analysis of Week 12 of the Treatment Period||||0.041
72515409|NCT01146951|144561587|SUPERIORITY_OR_OTHER|||||||0.007|||||||Wilcoxon (Mann-Whitney)|||Analysis of final assessment (LOCF)||||0.007
72515410|NCT01299610|144561588|SUPERIORITY_OR_OTHER||Difference in Adjusted Means|-0.38|STANDARD_ERROR_OF_MEAN|0.538||0.48|TWO_SIDED|95.0|-1.46|0.7|||Mixed model for repeated measures|||||0.70|-1.46|0.480
72515411|NCT01299610|144561588|SUPERIORITY_OR_OTHER||mixed model for repeated measures|-0.89|STANDARD_ERROR_OF_MEAN|0.557||0.118|TWO_SIDED|95.0|-2.0|0.23|||Mixed model for repeated measures|||||0.23|-2.00|0.118
72515412|NCT01299610|144561588|SUPERIORITY_OR_OTHER||Difference in Adjusted Means|-1.51|STANDARD_ERROR_OF_MEAN|0.572||0.011|TWO_SIDED|95.0|-2.65|-0.36|||Mixed model for repeated measures|||||-0.36|-2.65|0.011
72515413|NCT01299610|144561589|SUPERIORITY_OR_OTHER||Difference in Adjusted Means|0.09|STANDARD_ERROR_OF_MEAN|0.16||0.581|TWO_SIDED|95.0|-0.24|0.42|||Mixed model repeated measures|||GW870086, 0.2% cream Vs Placebo: Day 2||0.42|-0.24|0.581
72515414|NCT01299610|144561589|SUPERIORITY_OR_OTHER||Difference in Adjusted Means|-0.08|STANDARD_ERROR_OF_MEAN|0.169||0.655|TWO_SIDED|95.0|-0.42|0.27|||Mixed model repeated measures|||GW870086, 2.0% cream Vs Placebo: Day 2||0.27|-0.42|0.655
72568421|NCT01195272|144668247|SUPERIORITY_OR_OTHER|||||||0.22|||||||ANOVA|||Visit 3 versus Visit 2||||0.22
72515415|NCT01299610|144561589|SUPERIORITY_OR_OTHER||Difference in Adjusted Means|-0.17|STANDARD_ERROR_OF_MEAN|0.174||0.336||95.0|-0.52|0.18|||Mixed model repeated measures|||FP, 0.05% cream Vs Placebo: Day 2||0.18|-0.52|0.336
72515416|NCT01299610|144561589|SUPERIORITY_OR_OTHER||Difference in Adjusted Means|0.03|STANDARD_ERROR_OF_MEAN|0.302||0.923|TWO_SIDED|95.0|-0.58|0.63|||Mixed model repeated measures|||GW870086 0.2% cream Vs Placebo: Day 3||0.63|-0.58|0.923
72515417|NCT01299610|144561589|SUPERIORITY_OR_OTHER||Difference in Adjusted Means|0.14|STANDARD_ERROR_OF_MEAN|0.314||0.657|TWO_SIDED|95.0|-0.49|0.77|||Mixed model repeated measures|||GW870086, 2.0% cream, Placebo: Day 3||0.77|-0.49|0.657
72515418|NCT01299610|144561589|SUPERIORITY_OR_OTHER||Difference in Adjusted Means|-0.28|STANDARD_ERROR_OF_MEAN|0.323||0.386|TWO_SIDED|95.0|-0.93|0.36|||Mixed model repeated measures|||Placebo, FP, 0.05% cream: Day 3||0.36|-0.93|0.386
72515419|NCT01299610|144561589|SUPERIORITY_OR_OTHER||Difference in Adjusted Means|-0.24|STANDARD_ERROR_OF_MEAN|0.456||0.601|TWO_SIDED|95.0|-1.15|0.67|||Mixed model repeated measures|||GW870086, 0.2% cream, Placebo: Day 7||0.67|-1.15|0.601
72515420|NCT01299610|144561589|SUPERIORITY_OR_OTHER||Difference in Adjusted Means|-0.6|STANDARD_ERROR_OF_MEAN|0.472||0.212|TWO_SIDED|95.0|-1.54|0.35|||Mixed model repeated measures|||GW870086, 2.0% cream, Placebo: Day 7||0.35|-1.54|0.212
72515421|NCT01299610|144561589|SUPERIORITY_OR_OTHER||Difference in Adjusted Means|-1.29|STANDARD_ERROR_OF_MEAN|0.485||0.01|TWO_SIDED|95.0|-2.26|-0.32|||Mixed model repeated measures|||Placebo, FP, 0.05% cream: Day 7||-0.32|-2.26|0.010
72515422|NCT01299610|144561589|SUPERIORITY_OR_OTHER||Difference in Adjusted Means|-0.24|STANDARD_ERROR_OF_MEAN|0.462||0.602|TWO_SIDED|95.0|-1.17|0.68|||Mixed model repeated measures|||GW870086, 0.2% cream, Placebo: Day 14||0.68|-1.17|0.602
72515423|NCT01299610|144561589|SUPERIORITY_OR_OTHER||Difference in Adjusted Means|-0.65|STANDARD_ERROR_OF_MEAN|0.479||0.18|TWO_SIDED|95.0|-1.61|0.31|||Mixed model repeated measures|||GW870086, 2.0% cream, Placebo: Day 14||0.31|-1.61|0.180
72515424|NCT01299610|144561589|SUPERIORITY_OR_OTHER||Difference in Adjusted Means|-1.39|STANDARD_ERROR_OF_MEAN|0.492||0.006|TWO_SIDED|95.0|-2.37|-0.4|||Mixed model repeated measures|||Placebo, FP, 0.05% cream: Day 14||-0.40|-2.37|0.006
72515425|NCT00804843|144561599|SUPERIORITY_OR_OTHER||Least Square Mean Difference|0.27||||0.811|TWO_SIDED|90.0|-0.24|0.78|||ANOVA|||||0.78|-0.24|0.811
72515426|NCT00804843|144561600|SUPERIORITY_OR_OTHER||Least Square Mean Difference|3.64||||0.898|TWO_SIDED|90.0|-1.09|8.36|||ANOVA|||||8.36|-1.09|0.898
72515427|NCT02126670|144561615|SUPERIORITY_OR_OTHER|||||||0.799|TWO_SIDED||||||Chi-squared|||||||0.799
72515428|NCT04172701|144561617|OTHER||||||<|0.0001|||||||Individual log-linked Poisson model|||||||<0.0001
72515429|NCT04172701|144561618|OTHER||||||<|0.001|||||||Individual t-test or Wilcoxon test|||||||<0.001
72515430|NCT04172701|144561619|OTHER||||||<|0.0001|||||||Log Rank|||||||<0.0001
72515431|NCT04172701|144561620|OTHER||Hazard Ratio (HR)|1.475|||<|0.0001|TWO_SIDED|95.0|1.308|1.663|||Regression, Cox|||The Cox proportional hazards regression took into account the fact that individual matching (1:1) was performed by considering the exposed patient and his/her matched control as one stratum and including this as a stratum in the Cox proportional hazards model.The presented Hazard Ratio (HR) was estimated using the LAMA as a reference group.||1.663|1.308|<0.0001
72515432|NCT04172701|144561621|OTHER|||||||0.0003|||||||Individual log-linked Poisson model|||||||0.0003
72515433|NCT04172701|144561622|OTHER|||||||0.001|||||||Individual t-test or Wilcoxon test|||||||0.001
72515434|NCT04172701|144561623|OTHER||Hazard Ratio (HR)|1.145||||0.0006|TWO_SIDED|95.0|1.059|1.237|||Regression, Cox|||The Cox proportional hazards regression took into account the fact that individual matching (1:1) was performed by considering the exposed patient and his/her matched control as one stratum and including this as a stratum in the Cox proportional hazards model. The presented Hazard Ratio (HR) was estimated using the LAMA as a reference group.||1.237|1.059|0.0006
72515435|NCT04172701|144561624|OTHER|||||||0.00074|||||||Log Rank|||||||0.00074
72515436|NCT04172701|144561625|OTHER||||||<|0.0001|||||||Individual log-linked Poisson model|||||||<0.0001
72515437|NCT04172701|144561626|OTHER||Hazard Ratio (HR)|1.601|||<|0.0001|TWO_SIDED|95.0|1.404|1.826|||Regression, Cox|||The Cox proportional hazards regression took into account the fact that individual matching (1:1) was performed by considering the exposed patient and his/her matched control as one stratum and including this as a stratum in the Cox proportional hazards model. The presented Hazard Ratio (HR) was estimated using the LAMA as a reference group.||1.826|1.404|<0.0001
72515438|NCT04172701|144561627|OTHER||||||<|0.0001|||||||Log Rank|||||||<0.0001
72515439|NCT04172701|144561628|OTHER|||||||0.2875|||||||Wilcoxon (Mann-Whitney)|||||||0.2875
72515440|NCT04172701|144561629|OTHER|||||||0.4602|||||||Individual t-test or Wilcoxon test|||||||0.4602
72515441|NCT04172701|144561630|OTHER|||||||0.0062|||||||Wilcoxon (Mann-Whitney)|||||||0.0062
72515442|NCT04172701|144561631|OTHER|||||||0.0002|||||||Individual t-test or Wilcoxon test|||||||0.0002
72515443|NCT04172701|144561632|OTHER|||||||0.4907|||||||Individual t-test or Wilcoxon test|||||||0.4907
72515444|NCT04172701|144561633|OTHER||||||<|0.001|||||||Individual t-test or Wilcoxon test|||||||<0.001
72515445|NCT04172701|144561634|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
72515446|NCT04172701|144561635|OTHER|||||||0.543|||||||Individual t-test or Wilcoxon test|||||||0.543
72515447|NCT04172701|144561636|OTHER|||||||0.08|||||||Wilcoxon (Mann-Whitney)|||||||0.080
72515448|NCT04172701|144561637|OTHER|||||||0.363|||||||Individual t-test or Wilcoxon test|||||||0.363
72515449|NCT04172701|144561638|OTHER||||||<|0.0001|||||||Individual t-test or Wilcoxon test|||||||<0.0001
72515450|NCT04172701|144561639|OTHER|||||||0.0494|||||||Individual t-test or Wilcoxon test|||||||0.0494
72515451|NCT04172701|144561640|OTHER|||||||0.0091|||||||Individual t-test or Wilcoxon test|||||||0.0091
72515452|NCT04172701|144561641|OTHER||||||<|0.0001|||||||Individual t-test or Wilcoxon test|||||||<0.0001
72403830|NCT04414553|144313803|SUPERIORITY|||||||0.29||||||Threshold for statistical significance was \<0.05|t-test, 2 sided|||This compares pre/post data.||||0.29
72515453|NCT04172701|144561642|OTHER||||||<|0.0001|||||||Individual t-test or Wilcoxon test|||||||<0.0001
72515454|NCT04172701|144561643|OTHER|||||||0.7298|||||||Individual t-test or Wilcoxon test|||||||0.7298
72515455|NCT04172701|144561644|OTHER|||||||0.0093|||||||Individual t-test or Wilcoxon test|||||||0.0093
72515456|NCT04172701|144561645|OTHER||||||<|0.0001|||||||Individual t-test or Wilcoxon test|||||||<0.0001
72568422|NCT01195272|144668247|SUPERIORITY_OR_OTHER|||||||0.44|||||||ANOVA|||Visit 5 versus Visit 2||||0.44
72568423|NCT01195272|144668247|SUPERIORITY_OR_OTHER|||||||0.23|||||||ANOVA|||Visit 5 versus Visit 3||||0.23
72568424|NCT01195272|144668248|SUPERIORITY_OR_OTHER|||||||0.22|||||||ANOVA|||Visit 3 versus Visit 2||||0.22
72568425|NCT01195272|144668248|SUPERIORITY_OR_OTHER|||||||0.46|||||||ANOVA|||Visit 5 versus Visit 2||||0.46
72568426|NCT01195272|144668248|SUPERIORITY_OR_OTHER|||||||0.24|||||||ANOVA|||Visit 5 versus Visit 3||||0.24
72515457|NCT04172701|144561646|OTHER||Cost ratio|1.177|||<|0.0001|TWO_SIDED|95.0|1.104|1.255|||Individual t-test or Wilcoxon test||cost ratio = cost of ICS/LABA divided by cost of LAMA|||1.255|1.104|<0.0001
72515458|NCT04172701|144561647|OTHER||Cost ratio|1.194||||0.0103|TWO_SIDED|95.0|1.043|1.367|||Individual t-test or Wilcoxon test||cost ratio = cost of ICS/LABA divided by cost of LAMA|||1.367|1.043|0.0103
72515459|NCT04172701|144561648|OTHER||Cost ratio|1.104||||0.003|TWO_SIDED|95.0|1.034|1.178|||Individual t-test or Wilcoxon test||cost ratio = cost of ICS/LABA divided by cost of LAMA|||1.178|1.034|0.0030
72515460|NCT04172701|144561649|OTHER||Cost ratio|1.175|||<|0.0001|TWO_SIDED|95.0|1.13|1.221|||Individual t-test or Wilcoxon test||cost ratio = cost of ICS/LABA divided by cost of LAMA|||1.221|1.130|<0.0001
72403831|NCT04414553|144313804|SUPERIORITY|||||||0.35|||||||Chi-squared|||||||0.35
72403832|NCT04414553|144313805|SUPERIORITY|||||||0.21|||||||Chi-squared|||||||0.21
72403833|NCT04414553|144313806|SUPERIORITY|||||||0.018|||||||t-test, 2 sided|||||||0.018
72403834|NCT04414553|144313807|SUPERIORITY|||||||0.062|||||||t-test, 2 sided|||||||0.062
72403835|NCT00591942|144313824|NON_INFERIORITY|95% CI were used|KM Survival Curves|0.5637||||0.5637|TWO_SIDED||||||Chi-squared|df=1||||||0.5637
72515461|NCT04172701|144561650|OTHER||Cost ratio|1.236|||<|0.0001|TWO_SIDED|95.0|1.134|1.346|||Individual t-test or Wilcoxon test||cost ratio = cost of ICS/LABA divided by cost of LAMA|||1.346|1.134|<0.0001
72515462|NCT04172701|144561651|OTHER||Cost ratio|1.214||||0.0212|TWO_SIDED|95.0|1.029|1.431|||Individual t-test or Wilcoxon test||cost ratio = cost of ICS/LABA divided by cost of LAMA|||1.431|1.029|0.0212
72515463|NCT04172701|144561652|OTHER||Cost ratio|1.026||||0.5024|TWO_SIDED|95.0|0.952|1.105|||Individual t-test or Wilcoxon test||cost ratio = cost of ICS/LABA divided by cost of LAMA|||1.105|0.952|0.5024
72515464|NCT04172701|144561653|OTHER||Cost ratio|1.304|||<|0.0001|TWO_SIDED|95.0|1.243|1.369|||Individual t-test or Wilcoxon test||cost ratio = cost of ICS/LABA divided by cost of LAMA|||1.369|1.243|<0.0001
72515465|NCT04172701|144561654|OTHER|||||||0.7198|||||||Individual log-linked Poisson model|||||||0.7198
72515466|NCT04172701|144561655|OTHER||Hazard Ratio (HR)|1.072||||0.7341|TWO_SIDED|95.0|0.719|1.598|||Regression, Cox|||The Cox proportional hazards regression took into account the fact that individual matching (1:1) was performed by considering the exposed patient and his/her matched control as one stratum and including this as a stratum in the Cox proportional hazards model. The presented Hazard Ratio (HR) was estimated using the LAMA as a reference group.||1.598|0.719|0.7341
72515467|NCT04172701|144561656|OTHER|||||||0.74|||||||Log Rank|||||||0.74
72515468|NCT04172701|144561657|OTHER|||||||0.9985|||||||Individual log-linked Poisson model|||||||0.9985
72568427|NCT01195272|144668249|SUPERIORITY_OR_OTHER|||||||0.05|||||||ANOVA|||Visit 3 versus Visit 2||||0.05
72568428|NCT01195272|144668249|SUPERIORITY_OR_OTHER|||||||0.01|||||||ANOVA|||Visit 5 versus Visit 2||||0.01
72568429|NCT01195272|144668249|SUPERIORITY_OR_OTHER|||||||0.18|||||||ANOVA|||Visit 5 versus Visit 3||||0.18
72568430|NCT01195272|144668250|SUPERIORITY_OR_OTHER|||||||0.48|||||||ANOVA|||Visit 3 versus Visit 2||||0.48
72568431|NCT01195272|144668250|SUPERIORITY_OR_OTHER|||||||0.43|||||||ANOVA|||Visit 5 versus Visit 2||||0.43
72568432|NCT01195272|144668250|SUPERIORITY_OR_OTHER|||||||0.44|||||||ANOVA|||Visit 5 versus Visit 3||||0.44
72568433|NCT01195272|144668251|SUPERIORITY_OR_OTHER|||||||0.313|||||||ANOVA|||Visit 3 versus Visit 2||||0.313
72568434|NCT01195272|144668251|SUPERIORITY_OR_OTHER|||||||0.083|||||||ANOVA|||Visit 5 versus Visit 2||||0.083
72568435|NCT01195272|144668251|SUPERIORITY_OR_OTHER|||||||0.092|||||||ANOVA|||Visit 5 versus Visit 3||||0.092
72568436|NCT01195272|144668251|SUPERIORITY_OR_OTHER|||||||0.145|||||||ANOVA|||Visit 8 versus Visit 2||||0.145
72568437|NCT01195272|144668251|SUPERIORITY_OR_OTHER|||||||0.398|||||||ANOVA|||Visit 8 versus Visit 3||||0.398
72568438|NCT01195272|144668251|SUPERIORITY_OR_OTHER|||||||0.138|||||||ANOVA|||Visit 8 versus Visit 5||||0.138
72568439|NCT01195272|144668252|SUPERIORITY_OR_OTHER|||||||0.467|||||||ANOVA|||Visit 3 versus Visit 2||||0.467
72568440|NCT01195272|144668252|SUPERIORITY_OR_OTHER|||||||0.25|||||||ANOVA|||Visit 5 versus Visit 2||||0.250
72568441|NCT01195272|144668252|SUPERIORITY_OR_OTHER|||||||0.06|||||||ANOVA|||Visit 5 versus Visit 3||||0.060
72568442|NCT01195272|144668252|SUPERIORITY_OR_OTHER|||||||0.149|||||||ANOVA|||Visit 8 versus Visit 2||||0.149
72568443|NCT01195272|144668252|SUPERIORITY_OR_OTHER|||||||0.061|||||||ANOVA|||Visit 8 versus Visit 3||||0.061
72568444|NCT01195272|144668252|SUPERIORITY_OR_OTHER|||||||0.047|||||||ANOVA|||Visit 8 versus Visit 5||||0.047
72568445|NCT01195272|144668253|SUPERIORITY_OR_OTHER|||||||0.169|||||||ANOVA|||Visit 3 versus Visit 2||||0.169
72568446|NCT01195272|144668253|SUPERIORITY_OR_OTHER|||||||0.165|||||||ANOVA|||Visit 5 versus Visit 2||||0.165
72568447|NCT01195272|144668253|SUPERIORITY_OR_OTHER|||||||0.471|||||||ANOVA|||Visit 5 versus Visit 3||||0.471
72568448|NCT01195272|144668253|SUPERIORITY_OR_OTHER|||||||0.243|||||||ANOVA|||Visit 8 versus Visit 2||||0.243
72488306|NCT01431274|144505149|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.079|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|0.055|0.103||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within-patient errors."|||0.103|0.055|<0.0001
72515469|NCT04172701|144561658|OTHER||Hazard Ratio (HR)|0.879||||0.5097|TWO_SIDED|95.0|0.6|1.289|||Regression, Cox|||The Cox proportional hazards regression took into account the fact that individual matching (1:1) was performed by considering the exposed patient and his/her matched control as one stratum and including this as a stratum in the Cox proportional hazards model. The presented Hazard Ratio (HR) was estimated using the LAMA as a reference group.||1.289|0.600|0.5097
72515470|NCT04172701|144561659|OTHER|||||||0.51|||||||Log Rank|||||||0.51
72515471|NCT04172701|144561660|OTHER|||||||0.6069|||||||Individual log-linked Poisson model|||||||0.6069
72515472|NCT04172701|144561661|OTHER||Hazard Ratio (HR)|1.025||||0.896|TWO_SIDED|95.0|0.705|1.49|||Regression, Cox|||The Cox proportional hazards regression took into account the fact that individual matching (1:1) was performed by considering the exposed patient and his/her matched control as one stratum and including this as a stratum in the Cox proportional hazards model. The presented Hazard Ratio (HR) was estimated using the LAMA as a reference group.||1.490|0.705|0.8960
72515473|NCT04172701|144561662|OTHER|||||||0.9|||||||Log Rank|||||||0.9
72515474|NCT04172701|144561663|OTHER|||||||0.1354|||||||Individual log-linked Poisson model|||||||0.1354
72515475|NCT04172701|144561664|OTHER||Hazard Ratio (HR)|0.59||||0.1158|TWO_SIDED|95.0|0.305|1.139|||Regression, Cox|||The Cox proportional hazards regression took into account the fact that individual matching (1:1) was performed by considering the exposed patient and his/her matched control as one stratum and including this as a stratum in the Cox proportional hazards model. The presented Hazard Ratio (HR) was estimated using the LAMA as a reference group.||1.139|0.305|0.1158
72515476|NCT04172701|144561665|OTHER|||||||0.11|||||||Log Rank|||||||0.11
72515477|NCT01975246|144561666|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.9|STANDARD_ERROR_OF_MEAN|0.7|<|0.0001|TWO_SIDED|95.0|-5.3|-2.4|||ANCOVA|Model includes baseline DBP as a linear covariate, and treatment and center as fixed effects.||The last observation carried forward (LOCF) method was applied for missing data, where the value from the measurements at the closest preceding visit replaced the missing value.||-2.4|-5.3|<0.0001
72568449|NCT01195272|144668253|SUPERIORITY_OR_OTHER|||||||0.396|||||||ANOVA|||Visit 8 versus Visit 3||||0.396
72403836|NCT03519971|144313829|SUPERIORITY||Hazard Ratio (HR)|0.85||||0.247|TWO_SIDED|95.0|0.647|1.123|||Log Rank|The analysis was performed using the stratified log-rank test, adjusting for age (\< 65 vs. \>= 65 years) and stage (IIIA vs. IIIB/C).||The hazard ratio (HR) and confidence intervals (CIs) were calculated using a stratified Cox proportional hazards model, adjusting for age \[\< 65 versus (vs.) \>= 65 years\] and stage (IIIA vs. IIIB/C), with treatment as the only covariate and ties handled by Efron approach.||1.123|0.647|0.247
72488307|NCT01431274|144505149|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.062|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|0.038|0.086||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Tiotropium (5 μg).~Spatial power covariance structure for within-patient errors."|||0.086|0.038|<0.0001
72488308|NCT01431274|144505149|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.061|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|0.037|0.085||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within-patient errors."|||0.085|0.037|<0.0001
72488309|NCT01431274|144505149|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.047|STANDARD_ERROR_OF_MEAN|0.012||0.0002|TWO_SIDED|95.0|0.022|0.071||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.071|0.022|0.0002
72488310|NCT01431274|144505149|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.044|STANDARD_ERROR_OF_MEAN|0.012||0.0004|TWO_SIDED|95.0|0.019|0.068||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (5 µg).~Spatial power covariance structure for within-patient errors."|||0.068|0.019|0.0004
72488311|NCT01431274|144505149|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.018|STANDARD_ERROR_OF_MEAN|0.012||0.136|TWO_SIDED|95.0|-0.006|0.042||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tio+Olo FDC (2.5/5 µg).~Spatial power covariance structure for within-patient errors."|||0.042|-0.006|0.1360
72488312|NCT01431274|144505149|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.065|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|0.041|0.089||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.089|0.041|<0.0001
72488313|NCT01431274|144505149|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.017|STANDARD_ERROR_OF_MEAN|0.012||0.1617|TWO_SIDED|95.0|-0.007|0.041||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within-patient errors."|||0.041|-0.007|0.1617
72488314|NCT01431274|144505149|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.014|STANDARD_ERROR_OF_MEAN|0.012||0.2476|TWO_SIDED|95.0|-0.01|0.039||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (2.5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within-patient errors."|||0.039|-0.010|0.2476
72488315|NCT01431274|144505149|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.003|STANDARD_ERROR_OF_MEAN|0.012||0.8083|TWO_SIDED|95.0|-0.021|0.027||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.027|-0.021|0.8083
72515478|NCT01975246|144561667|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.3|STANDARD_ERROR_OF_MEAN|1.1|<|0.0001|TWO_SIDED|95.0|-7.6|-3.1|||ANCOVA|Model includes baseline SBP as a linear covariate, and treatment and center as fixed effects.||The last observation carried forward (LOCF) method was applied for missing data, where the value from the measurements at the closest preceding visit replaced the missing value.||-3.1|-7.6|<0.0001
72515479|NCT01975246|144561668|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.1|||<|0.0051|TWO_SIDED|95.0|1.2|3.4|||Regression, Logistic|Logistic regression model includes treatment and center as fixed effects.||"The Non-completers considered failure (NCF) method was applied for missing data, where missing data due to early discontinuation will be replaced as failure up to the planned final visit to be reached by all patients."||3.4|1.2|<0.0051
72515480|NCT01263093|144561670|SUPERIORITY_OR_OTHER||Ratio of Geometric Least Squares Means|0.77|||||TWO_SIDED|90.0|0.72|0.83|||Mixed Models Analysis||Statistical inference was made using the test treatment of LY2216684 + clopidogrel and the reference treatment of clopidogrel alone.|||0.83|0.72|
72515481|NCT01263093|144561671|SUPERIORITY_OR_OTHER||Ratio of Geometric Least Squares Means|0.59|||||TWO_SIDED|90.0|0.53|0.67|||Mixed Models Analysis||Statistical inference was made using the test treatment of LY2216684 + clopidogrel and the reference treatment of clopidogrel alone.|||0.67|0.53|
72515482|NCT01263093|144561673|SUPERIORITY_OR_OTHER||Median of Paired Differences|0.0||||0.3303|TWO_SIDED|90.0|0.0|0.25|||Wilcoxon (Mann-Whitney)|||||0.25|0.00|0.3303
72403837|NCT03519971|144313830|SUPERIORITY||Difference in percentages|0.2||||0.976|TWO_SIDED|99.5|-15.2|16.3|||Cochran-Mantel-Haenszel|The analysis was performed using a Cochran-Mantel-Haenszel (CMH) test, stratified by age (\< 65 vs. \>= 65 years) and stage (IIIA vs. IIIB/C).|The CIs for difference in percentages were estimated using Miettinen and Nurminen's method.|||16.3|-15.2|0.976
72403838|NCT03519971|144313831|SUPERIORITY|The HR and CIs were calculated using a stratified Cox proportional hazards model, adjusting for age (\< 65 vs. \>= 65 years) and stage (IIIA vs. IIIB/C), with treatment as the only covariate and ties handled by Efron approach.|Hazard Ratio (HR)|1.03||||0.823|TWO_SIDED|95.0|0.778|1.386|||Log Rank|The analysis was performed using the stratified log-rank test, adjusting for age (\< 65 vs. \>= 65 years) and stage (IIIA vs. IIIB/C).||||1.386|0.778|0.823
72403839|NCT03519971|144313832|SUPERIORITY|For the comparison between treatments, the Kaplan-Meier estimator of survival at 24 months for each treatment was used to obtain the HR and the test is based on the method described in Klein 2007. To account for the stratification factors, the estimates and test statistics in each strata were combined by weighting inversely proportionately according to each within stratum variance.|Hazard Ratio (HR)|1.04||||0.847|TWO_SIDED|95.0|0.716|1.502|||Log Rank|The analysis was performed using the stratified log-rank test, adjusting for age (\< 65 vs. \>= 65 years) and stage (IIIA vs. IIIB/C).||||1.502|0.716|0.847
72488316|NCT01431274|144505150|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.1|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|0.075|0.124||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within-patient errors."|||0.124|0.075|<0.0001
72488317|NCT01431274|144505150|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.064|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|0.039|0.088||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Tiotropium (5 μg).~Spatial power covariance structure for within-patient errors."|||0.088|0.039|<0.0001
72488318|NCT01431274|144505150|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.076|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|0.051|0.1||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within-patient errors."|||0.100|0.051|<0.0001
72488319|NCT01431274|144505150|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.048|STANDARD_ERROR_OF_MEAN|0.013||0.0001|TWO_SIDED|95.0|0.023|0.072||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.072|0.023|0.0001
72488320|NCT01431274|144505150|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.04|STANDARD_ERROR_OF_MEAN|0.012||0.0014|TWO_SIDED|95.0|0.015|0.064||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (5 µg).~Spatial power covariance structure for within-patient errors."|||0.064|0.015|0.0014
72488321|NCT01431274|144505150|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.024|STANDARD_ERROR_OF_MEAN|0.012||0.0554|TWO_SIDED|95.0|-0.001|0.048||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tio+Olo FDC (2.5/5 µg).~Spatial power covariance structure for within-patient errors."|||0.048|-0.001|0.0554
72488322|NCT01431274|144505150|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.071|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|0.047|0.096||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.096|0.047|<0.0001
72515483|NCT05263921|144561730|OTHER|The ratio and 90% CI were expressed as percentages.|Ratio (%) of Adjusted Geometric means|107.35|||||TWO_SIDED|90.0|99.66|115.64||||||Reference: Nirmatrelvir/ritonavir 300/100 mg commercial tablets; Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with water||115.64|99.66|
72515484|NCT05263921|144561730|OTHER|The ratio and 90% CI were expressed as percentages.|Ratio (%) of Adjusted Geometric Means|120.73|||||TWO_SIDED|90.0|112.09|130.03||||||Reference: Nirmatrelvir/ritonavir 300/100 mg commercial tablets Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with applesauce||130.03|112.09|
72515485|NCT05263921|144561730|OTHER|The ratio and 90% CI were expressed as percentages.|Ratio (%) of Adjusted Geometric Means|125.04|||||TWO_SIDED|90.0|116.08|134.69||||||Reference: Nirmatrelvir/ritonavir 300/100 mg commercial tablets Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with vanilla pudding||134.69|116.08|
72515486|NCT05263921|144561731|OTHER|The ratio and 90% CI were expressed as percentages.|Ratio (%) of Adjusted Geometric means|108.8|||||TWO_SIDED|90.0|101.06|117.14||||||Reference: Nirmatrelvir/ritonavir 300/100 mg commercial tablets; Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with water||117.14|101.06|
72403840|NCT03519971|144313833|SUPERIORITY|The analysis was performed using a CMH test, stratified by age (\< 65 vs. \>= 65 years) and stage (IIIA vs. IIIB/C).|Difference in percentages|0.0|||||TWO_SIDED|95.0|-4.8|3.0|||||The CIs for difference in percentages was calculated using Miettinen and Nurminen's method.|||3.0|-4.8|
72515487|NCT05263921|144561731|OTHER|The ratio and 90% CI were expressed as percentages.|Ratio (%) of Adjusted Geometric Means|120.95|||||TWO_SIDED|90.0|112.36|130.2||||||Reference: Nirmatrelvir/ritonavir 300/100 mg commercial tablets Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with applesauce||130.20|112.36|
72568450|NCT01195272|144668253|SUPERIORITY_OR_OTHER|||||||0.375|||||||ANOVA|||Visit 8 versus Visit 5||||0.375
72568451|NCT01195272|144668254|SUPERIORITY_OR_OTHER|||||||0.496|||||||ANOVA|||Visit 3 versus Visit 2||||0.496
72568452|NCT01195272|144668254|SUPERIORITY_OR_OTHER|||||||0.122|||||||ANOVA|||Visit 5 versus Visit 2||||0.122
72568453|NCT01195272|144668254|SUPERIORITY_OR_OTHER|||||||0.07|||||||ANOVA|||Visit 5 versus Visit 3||||0.070
72568454|NCT01195272|144668254|SUPERIORITY_OR_OTHER|||||||0.135|||||||ANOVA|||Visit 8 versus Visit 2||||0.135
72568455|NCT01195272|144668254|SUPERIORITY_OR_OTHER|||||||0.082|||||||ANOVA|||Visit 8 versus Visit 3||||0.082
72568456|NCT01195272|144668254|SUPERIORITY_OR_OTHER|||||||0.461|||||||ANOVA|||Visit 8 versus Visit 5||||0.461
72515488|NCT05263921|144561731|OTHER|The ratio and 90% CI were expressed as percentages.|Ratio (%) of Adjusted Geometric Means|127.39|||||TWO_SIDED|90.0|118.32|137.15||||||Reference: Nirmatrelvir/ritonavir 300/100 mg commercial tablets Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with vanilla pudding||137.15|118.32|
72515489|NCT05263921|144561732|OTHER|The ratio and 90% CI were expressed as percentages.|Ratio (%) of Adjusted Geometric means|115.1|||||TWO_SIDED|90.0|104.03|127.34||||||Reference: Nirmatrelvir/ritonavir 300/100 mg commercial tablets; Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with water||127.34|104.03|
72515490|NCT05263921|144561732|OTHER|The ratio and 90% CI were expressed as percentages.|Ratio (%) of Adjusted Geometric Means|145.6|||||TWO_SIDED|90.0|131.68|160.99||||||Reference: Nirmatrelvir/ritonavir 300/100 mg commercial tablets Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with applesauce||160.99|131.68|
72515491|NCT05263921|144561732|OTHER|The ratio and 90% CI were expressed as percentages.|Ratio (%) of Adjusted Geometric Means|161.48|||||TWO_SIDED|90.0|145.95|178.66||||||Reference: Nirmatrelvir/ritonavir 300/100 mg commercial tablets Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with vanilla pudding||178.66|145.95|
72515492|NCT05263921|144561733|OTHER|The ratio and 90% CI were expressed as percentages.|Ratio (%) of Adjusted Geometric means|110.85|||||TWO_SIDED|90.0|95.38|128.82||||||Reference: Nirmatrelvir/ritonavir 300/100 mg commercial tablets; Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with water||128.82|95.38|
72515493|NCT05263921|144561733|OTHER|The ratio and 90% CI were expressed as percentages.|Ratio (%) of Adjusted Geometric Means|106.55|||||TWO_SIDED|90.0|91.76|123.73||||||Reference: Nirmatrelvir/ritonavir 300/100 mg commercial tablets Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with applesauce||123.73|91.76|
72515494|NCT05263921|144561733|OTHER|The ratio and 90% CI were expressed as percentages.|Ratio (%) of Adjusted Geometric Means|107.74|||||TWO_SIDED|90.0|92.7|125.21||||||Reference: Nirmatrelvir/ritonavir 300/100 mg commercial tablets Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with vanilla pudding||125.21|92.70|
72515495|NCT05263921|144561734|OTHER|The ratio and 90% CI were expressed as percentages.|Ratio (%) of Adjusted Geometric means|110.19|||||TWO_SIDED|90.0|94.51|128.47||||||Reference: Nirmatrelvir/ritonavir 300/100 mg commercial tablets; Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with water||128.47|94.51|
72568457|NCT04319718|144668266|OTHER|||||||0.025|||||||Fisher Exact|||||||.025
72515496|NCT05263921|144561734|OTHER|The ratio and 90% CI were expressed as percentages.|Ratio (%) of Adjusted Geometric Means|107.17|||||TWO_SIDED|90.0|92.0|124.86||||||Reference: Nirmatrelvir/ritonavir 300/100 mg commercial tablets Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with applesauce||124.86|92.00|
72568458|NCT04319718|144668267|OTHER|||||||0.47|||||||Wilcoxon (Mann-Whitney)|||||||.47
72515497|NCT05263921|144561734|OTHER|The ratio and 90% CI were expressed as percentages.|Ratio (%) of Adjusted Geometric Means|107.83|||||TWO_SIDED|90.0|92.48|125.72||||||Reference: Nirmatrelvir/ritonavir 300/100 mg commercial tablets Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with vanilla pudding||125.72|92.48|
72515498|NCT05263921|144561735|OTHER|The ratio and 90% CI were expressed as percentages.|Ratio (%) of Adjusted Geometric means|108.72|||||TWO_SIDED|90.0|89.32|132.32||||||Reference: Nirmatrelvir/ritonavir 300/100 mg commercial tablets; Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with water||132.32|89.32|
72568459|NCT04319718|144668271|OTHER|||||||0.67|||||||Wilcoxon (Mann-Whitney)|||||||.67
72568460|NCT04319718|144668272|OTHER|||||||0.51|||||||Wilcoxon (Mann-Whitney)|||||||.51
72568461|NCT04319718|144668273|OTHER|||||||0.09|||||||Wilcoxon (Mann-Whitney)|||||||.09
72568462|NCT04319718|144668274|OTHER|||||||0.65|||||||Mixed Models Analysis|||||||.65
72568463|NCT04319718|144668274|OTHER|||||||0.24|||||||Mixed Models Analysis|||||||.24
72568464|NCT04319718|144668274|OTHER|||||||0.27|||||||Mixed Models Analysis|||||||.27
72568465|NCT04551911|144668301|OTHER|||||||0.7856|||||||Regression, Logistic|Logistic regression with treatment as the main effect, and baseline aggregate symptom score, baseline 25D level, and body weight as covariates||||||0.7856
72568466|NCT01030341|144668309|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Type I error: 0.05; power: 0.9|||||<|0.0001||||||Threshold for statistical significance: p \< 0.05|Regression, Logistic|Generalized estimating equations (GEE) with independent working correlation to account for correlated data comparing screening and treatment phases||Null hypothesis: Difference of 0% in the frequencies of hypoglycemic excursions (\<50 mg/dL) during the screening phase and treatment phase respectively.||||<0.0001
72568467|NCT01030341|144668309|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Type I error: 0.05; power: 0.9|||||<|0.0001||||||Threshold for statistical significance: p \< 0.05|Regression, Logistic|Generalized estimating equations (GEE) with independent working correlation to account for correlated data comparing screening and treatment phases||Null hypothesis: Difference of 0% in the frequencies of hypoglycemic excursions (\<70 mg/dL) during the screening phase and treatment phase respectively.||||<0.0001
72568468|NCT01030341|144668309|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Type I error: 0.05; power: 0.9||||||0.005||||||Threshold for statistical significance: p \< 0.05|Regression, Logistic|Generalized estimating equations (GEE) with independent working correlation to account for correlated data comparing screening and treatment phases||Null hypothesis: Difference of 0% in the frequencies of euglycemic excursions (70-180 mg/dL) during the screening phase and treatment phase respectively.||||0.005
72568469|NCT01030341|144668309|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Type I error: 0.05; power: 0.9||||||0.04||||||Threshold for statistical significance: p \< 0.05|Regression, Logistic|Generalized estimating equations (GEE) with independent working correlation to account for correlated data comparing screening and treatment phases||Null hypothesis: Difference of 0% in the frequencies of hyperglycemic excursions (\>180 mg/dL) during the screening phase and treatment phase respectively.||||0.04
72403841|NCT03519971|144313836|SUPERIORITY|The HR and CIs were calculated using a stratified Cox proportional hazards model, adjusting for age (\< 65 vs. \>= 65 years) and stage (IIIA vs. IIIB/C), with treatment as the only covariate and ties handled by Efron approach.|Hazard Ratio (HR)|0.95||||0.79|TWO_SIDED|95.0|0.649|1.413|||Log Rank|The analysis was performed using the stratified log-rank test, adjusting for age (\< 65 vs. \>= 65 years) and stage (IIIA vs. IIIB/C).||||1.413|0.649|0.790
72403842|NCT03519971|144313837|SUPERIORITY|The HR and CIs were calculated using a stratified Cox proportional hazards model, adjusting for age (\< 65 vs. \>= 65 years) and stage (IIIA vs. IIIB/C), with treatment as the only covariate and ties handled by Efron approach.|Hazard Ratio (HR)|0.81||||0.132|TWO_SIDED|95.0|0.614|1.071|||Log Rank|The analysis was performed using the stratified log-rank test, adjusting for age (\< 65 vs. \>= 65 years) and stage (IIIA vs. IIIB/C).||||1.071|0.614|0.132
72403843|NCT01774786|144313842|SUPERIORITY|The study was designed to have 80% power to show a significant difference with respect to the primary endpoint.|Hazard Ratio (HR)|0.84||||0.0565|TWO_SIDED|95.0|0.71|1.0||The actual p-value significance threshold required for OS was 0.0455, after alpha spent at the interim analysis was taken into account.|Stratified Log-Rank|Stratified analysis by geographic region, HER2 status, and prior gastrectomy.|HR was calculated as pertuzumab arm vs. placebo arm.|Primary Analysis. The null hypothesis is that the survival distribution of OS is the same in the two treatment arms.||1.00|0.71|0.0565
72403844|NCT01774786|144313842|OTHER|Exploratory|Hazard Ratio (HR)|0.85|||||TWO_SIDED|95.0|0.72|0.99|||||HR was calculated as pertuzumab arm vs. placebo arm. Stratified analysis by geographic region, HER2 status, and prior gastrectomy.|Final Analysis||0.99|0.72|
72403845|NCT01774786|144313843|SUPERIORITY||Hazard Ratio (HR)|0.73|||||TWO_SIDED|95.0|0.62|0.86||As pre-specified in the protocol, a p-value was only to be calculated for PFS if OS was statistically significant.|||A stratified Cox proportional hazards regression model was used to estimate the HR between the pertuzumab arm vs. the placebo arm.|Primary Analysis||0.86|0.62|
72403846|NCT01774786|144313843|OTHER|Exploratory|Hazard Ratio (HR)|0.73|||||TWO_SIDED|95.0|0.62|0.85|||||A stratified Cox proportional hazards regression model was used to estimate the HR between the pertuzumab arm vs. the placebo arm.|Final Analysis||0.85|0.62|
72403847|NCT01774786|144313844|OTHER|Exploratory|Difference in Objective Response|8.4|||||TWO_SIDED|95.0|0.89|15.91|||||Difference in objective response was calculated as the pertuzumab arm minus placebo arm.|Primary Analysis of Objective Response Rate||15.91|0.89|
72403848|NCT01774786|144313844|OTHER|Exploratory|Odds Ratio (OR)|1.4|||||TWO_SIDED|95.0|1.04|1.89|||||Odds ratio was calculated as the pertuzumab arm vs. placebo arm.|Primary Analysis of Objective Response Rate||1.89|1.04|
72403849|NCT01774786|144313845|OTHER|Exploratory|Difference in Objective Response|8.4|||||TWO_SIDED|95.0|0.89|15.91|||||Difference in objective response was calculated as the pertuzumab arm minus placebo arm.|Final Analysis of Objective Response Rate||15.91|0.89|
72403850|NCT01774786|144313845|OTHER|Exploratory|Odds Ratio (OR)|1.4|||||TWO_SIDED|95.0|1.04|1.89|||||Odds ratio was calculated as the pertuzumab arm vs. placebo arm.|Final Analysis of Objective Response Rate||1.89|1.04|
72403851|NCT01774786|144313846|OTHER|Exploratory|Hazard Ratio (HR)|0.82|||||TWO_SIDED|95.0|0.64|1.06|||||HR was calculated as pertuzumab arm vs. placebo arm. Stratified analysis by geographic region, HER2 status, and prior gastrectomy.|Primary Analysis||1.06|0.64|
72403852|NCT01774786|144313846|OTHER|Exploratory|Hazard Ratio (HR)|0.78|||||TWO_SIDED|95.0|0.62|0.98|||||HR was calculated as pertuzumab arm vs. placebo arm. Stratified analysis by geographic region, HER2 status, and prior gastrectomy.|Final Analysis||0.98|0.62|
72403853|NCT01774786|144313847|OTHER|Exploratory|Difference in Clinical Benefit Rate|3.37|||||TWO_SIDED|95.0|-2.34|9.07|||||Difference in clinical benefit rate was calculated as the pertuzumab arm minus placebo arm.|||9.07|-2.34|
72577121|NCT02045147|144680861|OTHER||Mean Difference (Final Values)|-2.4|STANDARD_ERROR_OF_MEAN|3.1||0.446|TWO_SIDED|95.0|-8.7|3.9|||t-test, 2 sided|||||3.9|-8.7|0.446
72488323|NCT01431274|144505150|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.036|STANDARD_ERROR_OF_MEAN|0.013||0.0041|TWO_SIDED|95.0|0.011|0.06||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within-patient errors."|||0.060|0.011|0.0041
72403854|NCT01774786|144313847|OTHER|Exploratory|Odds Ratio (OR)|1.27|||||TWO_SIDED|95.0|0.86|1.88|||||Odds ratio was calculated as the pertuzumab arm vs. placebo arm.|||1.88|0.86|
72403855|NCT04903249|144313870|OTHER|||||||0.137|||||||t-test, 2 sided|||||||0.137
72403856|NCT04903249|144313871|OTHER|||||||0.293|||||||t-test, 2 sided|||||||0.293
72403857|NCT04903249|144313872|OTHER|||||||0.609|||||||t-test, 2 sided|||||||0.609
72403858|NCT04903249|144313878|OTHER|||||||0.025|||||||t-test, 2 sided|||||||0.025
72403859|NCT04903249|144313879|OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
72403860|NCT04903249|144313880|OTHER|||||||0.327|||||||t-test, 2 sided|||||||.327
72403861|NCT04903249|144313881|OTHER|||||||0.479|||||||t-test, 2 sided|||||||0.479
72403862|NCT04903249|144313882|OTHER|||||||0.424|||||||t-test, 2 sided|||||||0.424
72403863|NCT04903249|144313883|OTHER|||||||0.279|||||||t-test, 2 sided|||||||0.279
72403864|NCT04903249|144313884|OTHER|||||||0.052|||||||t-test, 2 sided|||||||0.052
72488324|NCT01431274|144505150|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.028|STANDARD_ERROR_OF_MEAN|0.013||0.0248|TWO_SIDED|95.0|0.004|0.053||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (2.5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within-patient errors."|||0.053|0.004|0.0248
72488325|NCT01431274|144505150|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.008|STANDARD_ERROR_OF_MEAN|0.013||0.5338|TWO_SIDED|95.0|-0.017|0.032||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.032|-0.017|0.5338
72403865|NCT03556579|144313885|SUPERIORITY|"Superiority was concluded if the upper limit of the 95% confidence interval was below 0.~No sample size calculation was performed for this study since historical data was not available for either study lens for any of the primary endpoints."|Mean Difference (Final Values)|-0.68|STANDARD_ERROR_OF_MEAN|0.162|||TWO_SIDED|95.0|-1.01|-0.36|||Linear Mixed Model|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.|Mean difference was calculated as Test - Control|Without Distance Filter||-0.36|-1.01|
72515499|NCT05263921|144561735|OTHER|The ratio and 90% CI were expressed as percentages.|Ratio (%) of Adjusted Geometric Means|109.44|||||TWO_SIDED|90.0|90.05|133.0||||||Reference: Nirmatrelvir/ritonavir 300/100 mg commercial tablets Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with applesauce||133.00|90.05|
72515500|NCT05263921|144561735|OTHER|The ratio and 90% CI were expressed as percentages.|Ratio (%) of Adjusted Geometric Means|117.3|||||TWO_SIDED|90.0|96.37|142.77||||||Reference: Nirmatrelvir/ritonavir 300/100 mg commercial tablets Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with vanilla pudding||142.77|96.37|
72515501|NCT03292952|144561757|SUPERIORITY||||||<|0.001|||||||ANCOVA|||||||<0.001
72515502|NCT01061736|144561824|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.99||||0.1155|TWO_SIDED|95.0|0.85|4.64||Threshold for significance = 0.05.|Cochran-Mantel-Haenszel|||Analysis was performed using two-sided Cochran-Mantel-Haenszel test. Pairwise comparisons of the response rates between each dose of sarilumab and placebo were derived. The multiplicity issues were addressed by using the Hommel-procedure.||4.64|0.85|0.1155
72515503|NCT01061736|144561824|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.84||||0.0041|TWO_SIDED|95.0|1.53|9.63||Threshold for significance = 0.05.|Cochran-Mantel-Haenszel|||||9.63|1.53|0.0041
72515504|NCT01061736|144561824|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.17||||0.7119|TWO_SIDED|95.0|0.52|2.61||Threshold for significance = 0.05.|Cochran-Mantel-Haenszel|||||2.61|0.52|0.7119
72515505|NCT01061736|144561824|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.38||||0.0363|TWO_SIDED|95.0|1.06|5.35||Threshold for significance = 0.05.|Cochran-Mantel-Haenszel|||||5.35|1.06|0.0363
72515506|NCT01061736|144561824|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.34||||0.0426|TWO_SIDED|95.0|1.03|5.29||Threshold for significance = 0.05.|Cochran-Mantel-Haenszel|||||5.29|1.03|0.0426
72515507|NCT01061736|144561825|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.773|||<|0.0001|TWO_SIDED|95.0|2.077|3.703||Threshold for significance = 0.025.|Cochran-Mantel-Haenszel|||Analysis was performed using two-sided Cochran-Mantel-Haenszel test. Pairwise comparisons of the response rates between each dose of sarilumab and placebo was derived. The multiplicity issues for part B were addressed by using a Bonferroni correction for each dose together with a hierarchical testing procedure across the 3 co-primary and the main secondary endpoints. The hierarchical testing sequence continued only when previous endpoint was statistically significant at 0.025 level.||3.703|2.077|<0.0001
72515508|NCT01061736|144561825|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.975|||<|0.0001|TWO_SIDED|95.0|2.957|5.344||Threshold for significance = 0.025.|Cochran-Mantel-Haenszel|||||5.344|2.957|<0.0001
72515509|NCT01061736|144561826|SUPERIORITY_OR_OTHER||LS mean difference|-0.235|||<|0.0001|TWO_SIDED|95.0|-0.312|-0.157||Threshold for significance = 0.025.|Mixed Models Analysis|||Analysis was performed using a mixed model for repeated measures (MMRM). Differences in least square (LS) mean between each dose of sarilumab and placebo were derived. Testing was performed according to the hierarchical testing procedure (performed only when the previous endpoint was statistically significant).||-0.157|-0.312|<0.0001
72515510|NCT01061736|144561826|SUPERIORITY_OR_OTHER||LS mean difference|-0.258|||<|0.0001|TWO_SIDED|95.0|-0.336|-0.181||Threshold for significance = 0.025.|Mixed Models Analysis|||||-0.181|-0.336|<0.0001
72515511|NCT01061736|144561827|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Threshold for significance = 0.025.|Rank ANCOVA|||Analysis was performed using two-sided rank-based ANCOVA model. Testing was performed according to the hierarchical testing procedure (performed only when the previous endpoints were statistically significant).||||<0.0001
72515512|NCT01061736|144561827|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Threshold for significance = 0.025.|Rank ANCOVA|||||||<0.0001
72515513|NCT01061736|144561828|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.661|||<|0.0001|TWO_SIDED|95.0|2.451|8.863||Threshold for significance = 0.025.|Cochran-Mantel-Haenszel|||Analysis was performed using two-sided Cochran-Mantel-Haenszel test. Pairwise comparisons of the response rates between each dose of sarilumab and placebo were derived. Testing was performed according to the hierarchical testing procedure (performed only when the previous endpoints were statistically significant).||8.863|2.451|<0.0001
72515514|NCT01061736|144561828|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.565|||<|0.0001|TWO_SIDED|95.0|2.946|10.515||Threshold for significance = 0.025.|Cochran-Mantel-Haenszel|||||10.515|2.946|<0.0001
72515515|NCT00865189|144561897|SUPERIORITY_OR_OTHER|||||||0.015|||||||Binomial test|||This proportion was described for each treatment arm with a 95% confidence interval (CI) and compared with the standard proportion of 10% (CI) for each treatment arm.||||0.015
72515516|NCT00865189|144561897|SUPERIORITY_OR_OTHER|||||||0.906|||||||Binomial test|||This proportion was described for each treatment arm with a 95% CI and compared with the standard proportion of 10% (CI) using for each treatment arm.||||0.906
72515517|NCT01978509|144561916|SUPERIORITY|||||||0.7|||||||ANOVA|||||||0.70
72515518|NCT01594333|144561924|SUPERIORITY||Cox Proportional Hazard|1.01||||0.91|TWO_SIDED|95.0|0.82|1.25||2-sided unadjusted p-value|Log Rank|Stratified according to type of qualifying event, time of qualifying event and risk status(diabetes or metabolic syndrome alone)|Confidence intervals have not been adjusted for multiplicity, and therefore inferences drawn from these intervals may not be reproducible.|||1.25|0.82|0.91
72515519|NCT01594333|144561925|SUPERIORITY||Cox Proportional Hazard|0.96||||0.67|TWO_SIDED|95.0|0.79|1.16||2-sided unadjusted p-value|Log Rank|Stratified according to type of qualifying event, time of qualifying event and risk status(metabolic syndrome alone or diabetes at enrollment).|Confidence intervals have not been adjusted for multiplicity, and therefore inferences drawn from these intervals may not be reproducible.|||1.16|0.79|0.67
72577122|NCT02045147|144680862|OTHER||Mean Difference (Final Values)|2.7|STANDARD_ERROR_OF_MEAN|4.1||0.521|TWO_SIDED|95.0|-5.7|11.1|||t-test, 2 sided|||||11.1|-5.7|0.521
72515520|NCT01594333|144561926|SUPERIORITY||Cox Proportional Hazard|1.16||||0.32|TWO_SIDED|95.0|0.87|1.56||2-sided unadjusted p-value|Log Rank|Stratified according to type of qualifying event, time of qualifying event and risk status (metabolic syndrome alone or diabetes at enrollment).|Confidence intervals have not been adjusted for multiplicity, and therefore inferences drawn from these intervals may not be reproducible.|||1.56|0.87|0.32
72515521|NCT01594333|144561927|SUPERIORITY||Cox Proportional Hazard|0.95||||0.57|TWO_SIDED|95.0|0.81|1.12||2-sided unadjusted p-value|Log Rank|Stratified according to type of qualifying event, time of qualifying event and risk status (metabolic syndrome alone or diabetes) at enrollment.|Confidence intervals have not been adjusted for multiplicity, and therefore inferences drawn from these intervals may not be reproducible.|||1.12|0.81|0.57
72515522|NCT01594333|144561928|SUPERIORITY||Cox Proportional Hazard|0.89||||0.54|TWO_SIDED|95.0|0.6|1.31||2-sided unadjusted p-value|Log Rank|Stratified according to type of qualifying event, type of qualifying event and risk status (diabetes or metabolic syndrome alone) at enrollment|Confidence intervals have not been adjusted for multiplicity, and therefore inferences drawn from these intervals may not be reproducible.|||1.31|0.60|0.54
72515523|NCT01594333|144561929|SUPERIORITY||Cox Proportional Hazard|0.98||||0.8|TWO_SIDED|95.0|0.84|1.14||2-sided unadjusted p-value|Log Rank|Stratified according to type of qualifying event, time since qualifying event and risk status (diabetes or metabolic syndrome alone) at enrollment.|Confidence intervals have not been adjusted for multiplicity, and therefore inferences drawn from these intervals may not be reproducible.|||1.14|0.84|0.80
72515524|NCT01594333|144561931|SUPERIORITY||Cox Proportional Hazard|0.81||||0.31|TWO_SIDED|95.0|0.53|1.22||2-sided unadjusted p-value|Log Rank|Stratified according to type of qualifying event, time of qualifying event and risk status (diabetes or metabolic syndrome alone) at enrollment.|Confidence intervals have not been adjusted for multiplicity, and therefore inferences drawn from these intervals may not be reproducible.|||1.22|0.53|0.31
72515525|NCT01594333|144561932|SUPERIORITY||Cox Proportional Hazard|0.92||||0.38|TWO_SIDED|95.0|0.75|1.12||2-sided unadjusted p-value|Log Rank|Stratified according to type of qualifying event, time of qualifying event and risk status (diabetes or metabolic syndrome alone) at enrollment|Confidence intervals have not been adjusted for multiplicity, and therefore inferences drawn from these intervals may not be reproducible.|||1.12|0.75|0.38
72515526|NCT02666508|144561939|OTHER|Test conducted was a test of difference between plaque identifying toothpaste and non-plaque identifying toothpaste for change in DPIA from pre to post.|Mean Difference (Net)|-1.02||||0.001|TWO_SIDED|95.0|-1.6|-0.44|||Repeated Measures ANOVA|||||-0.44|-1.60|0.001
72515527|NCT02666508|144561940|OTHER|Test conducted was a test of the difference between plaque identifying toothpaste and non-plaque identifying toothpaste for change in hsCRP|Mean Difference (Net)|-0.18||||0.459|TWO_SIDED|95.0|-0.69|0.32|||Repeated Measures ANOVA|||||0.32|-0.69|0.459
72515528|NCT02475395|144562009|OTHER||Sensitivity|90.0|||||TWO_SIDED|95.0|79.9|95.3|||||Sensitivity estimates the percent true positive results obtained by Trak. Positive results are less than 15 M/mL sperm concentration and are part of a sub fertile diagnostic assessment.|||95.3|79.9|
72515529|NCT02475395|144562009|OTHER||Specificity|93.3|||||TWO_SIDED|95.0|88.7|96.1|||||Specificity is calculated by the percentage of true negative results obtained using Trak compared to reference method. Negative (for subfertility) results are greater than 15 M/mL.|||96.1|88.7|
72515530|NCT02475395|144562010|OTHER||Sensitivity|95.0|||||TWO_SIDED|95.0|86.3|98.3||||||||98.3|86.3|
72515531|NCT02475395|144562010|OTHER||Specificity|94.9|||||TWO_SIDED|95.0|90.6|97.3||||||||97.3|90.6|
72515532|NCT02475395|144562011|OTHER||Sensitivity|96.7|||||TWO_SIDED|95.0|88.7|99.1||||||||99.1|88.7|
72515533|NCT02475395|144562011|OTHER||Specificity|93.8|||||TWO_SIDED|95.0|89.2|96.5||||||||96.5|89.2|
72515534|NCT00115765|144562018|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.27||||0.011||95.0|1.06|1.52|||Regression, Cox|Model covariates were ECOG status, prior chemotherapy, metastatic organs, disease site, oxaliplatin dose \< 85 mg/m2, and oxaliplatin dose \> 100 mg/m2||||1.52|1.06|0.011
72515535|NCT00115765|144562019|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.43||||0.005||95.0|1.11|1.83|||Regression, Cox|Model covariates were ECOG status, prior chemotherapy, metastatic organs, disease site, oxaliplatin dose \< 85 mg/m2, and oxaliplatin dose \> 100 mg/m2||||1.83|1.11|0.005
72515536|NCT00115765|144562023|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.11||||0.738||95.0|0.6|2.05|||Regression, Logistic|Model covariates were ECOG status, prior adjuvant chemotherapy, number of metastatic organs, and primary disease site||||2.05|0.60|0.738
72568470|NCT01030341|144668309|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Type I error: 0.05; power: 0.9|||||<|0.0001||||||Threshold for statistical significance: p \< 0.05|Regression, Logistic|Generalized estimating equations (GEE) with independent working correlation to account for correlated data comparing screening and treatment phases||Null hypothesis: Difference of 0% in the frequencies of hyperglycemic excursions (\>300 mg/dL) during the screening phase and treatment phase respectively.||||<0.0001
72568471|NCT01030341|144668310|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Mean change = 0|||||<|0.0001|||||||paired t-test|||Null hypothesis: No difference in total GCSI score from screening to 12 weeks of treatment.||||<0.0001
72515537|NCT00115765|144562024|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.42||||0.257||95.0|0.77|2.62|||Regression, Cox|Model covariates were ECOG status, prior adjuvant chemotherapy, number of metastatic organs, and primary disease site||||2.62|0.77|0.257
72515538|NCT00115765|144562026|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.36||||||95.0|1.04|1.77||||||||1.77|1.04|
72515539|NCT00115765|144562027|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.25||||||95.0|0.91|1.71||||||||1.71|0.91|
72515540|NCT00115765|144562028|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.89||||||95.0|1.3|2.75||||||||2.75|1.30|
72515541|NCT00115765|144562029|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.02||||||95.0|0.67|1.54||||||||1.54|0.67|
72515542|NCT00115765|144562030|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.28||||||95.0|0.61|2.66||||||||2.66|0.61|
72515543|NCT00115765|144562031|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.68||||||95.0|0.28|1.67||||||||1.67|0.28|
72515544|NCT03519516|144562044|NON_INFERIORITY|it is considered as noninferiority if there is no difference greater than twenty percent between both medications||||||0.749|||||||Wilcoxon (Mann-Whitney)|||||||0.749
72515545|NCT03519516|144562045|NON_INFERIORITY|it is considered as noninferiority if there is no difference greater than twenty percent between both medications||||||0.041|||||||Chi-squared|||||||0.041
72515546|NCT03519516|144562046|NON_INFERIORITY|it is considered as noninferiority if there is no difference greater than twenty percent between both medications||||||0.694|||||||Wilcoxon (Mann-Whitney)|||||||0.694
72403866|NCT03556579|144313885|SUPERIORITY|"Superiority was concluded if the upper limit of the 95% confidence interval was below 0.~No sample size calculation was performed for this study since historical data was not available for either study lens for any of the primary endpoints."|Mean Difference (Final Values)|-1.13|STANDARD_ERROR_OF_MEAN|0.162|||TWO_SIDED|95.0|-1.45|-0.81|||Linear Mixed Model Analysis|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.|Mean difference was calculated as Test - Control|Without Distance Filter||-0.81|-1.45|
72403867|NCT03556579|144313886|SUPERIORITY|"Superiority was concluded if the upper limit of the 95% confidence interval was below 0.~No sample size calculation was performed for this study since historical data was not available for either study lens for any of the primary endpoints."|Mean Difference (Final Values)|-8.86|STANDARD_ERROR_OF_MEAN|2.173|||TWO_SIDED|95.0|-13.16|-4.55|||Linear Mixed Model|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.|Mean difference was calculated as Test - Control|||-4.55|-13.16|
72403868|NCT03556579|144313886|SUPERIORITY|"Superiority was concluded if the upper limit of the 95% confidence interval was below 0.~No sample size calculation was performed for this study since historical data was not available for either study lens for any of the primary endpoints."|Mean Difference (Final Values)|-24.93|STANDARD_ERROR_OF_MEAN|2.173|||TWO_SIDED|95.0|-29.24|-20.62|||Linear Mixed Model Analysis|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.|Mean difference was calculated as Test - Control|||-20.62|-29.24|
72403869|NCT03556579|144313887|SUPERIORITY|"Superiority was concluded if the lower limit of the 95% confidence interval was above 0.~No sample size calculation was performed for this study since historical data was not available for either study lens for any of the primary endpoints."|Mean Difference (Final Values)|0.19|STANDARD_ERROR_OF_MEAN|0.022|||TWO_SIDED|95.0|0.15|0.23|||Linear Mixed Model Analysis|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.|Mean Difference was calculated as Test minus Control|||0.23|0.15|
72403870|NCT03556579|144313888|SUPERIORITY|"Superiority was concluded if the upper limit of the 95% confidence interval was below 0.~No sample size calculation was performed for this study since historical data was not available for either study lens for any of the primary endpoints."|Mean Ratio|0.55|||||TWO_SIDED|95.0|0.46|0.65|||Generalized linear mixed model|Generalized Linear mixed model with a lognormal distribution using the Kenward and Roger method for the denominator degrees of freedom.||||0.65|0.46|
72403871|NCT03556579|144313889|SUPERIORITY|"Superiority was concluded if the upper limit of the 95% confidence interval was below 0.~No sample size calculation was performed for this study since historical data was not available for either study lens for any of the primary endpoints."|Mean Difference (Final Values)|-0.61|STANDARD_ERROR_OF_MEAN|0.23|||TWO_SIDED|95.0|-1.07|-0.15|||Linear Mixed Model|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.|Mean Difference was calculated as Test minus Control|||-0.15|-1.07|
72403872|NCT03556579|144313890|SUPERIORITY|"Superiority was concluded if the lower limit of the 95% confidence interval was above 0.~No sample size calculation was performed for this study since historical data was not available for either study lens for any of the primary endpoints."|Mean Difference (Final Values)|0.19|STANDARD_ERROR_OF_MEAN|0.022|||TWO_SIDED|95.0|0.14|0.23|||Linear Mixed Model Analysis|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.|Mean Difference was calculated as Test minus Control|||0.23|0.14|
72403873|NCT03556579|144313891|SUPERIORITY|"Superiority was concluded if the upper limit of the 95% confidence interval was below 0.~No sample size calculation was performed for this study since historical data was not available for either study lens for any of the primary endpoints."|Mean Difference (Final Values)|-30.56|STANDARD_ERROR_OF_MEAN|2.555|||TWO_SIDED|95.0|-31.66|-25.46|||Linear Mixed Model|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.|Mean difference was calculated as Test minus Control.|||-25.46|-31.66|
72403874|NCT03556579|144313891|SUPERIORITY|"Superiority was concluded if the upper limit of the 95% confidence interval was below 0.~No sample size calculation was performed for this study since historical data was not available for either study lens for any of the primary endpoints."|Mean Difference (Final Values)|-15.38|STANDARD_ERROR_OF_MEAN|2.555|||TWO_SIDED|95.0|-20.48|-10.27|||Linear Mixed Model|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.|Mean difference was calculated as Test Minus Control.|||-10.27|-20.48|
72403875|NCT00082433|144313915|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.79||||0.0005||95.0|0.69|0.9|||Log Rank|||The analysis was conducted when 903 progressions or deaths (446 in combination:457 in capecitabine) were observed in 960 participants.||.90|.69|.0005
72403876|NCT00082433|144313916|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.89|||<|0.0001||95.0|1.44|2.5|||Cochran-Mantel-Haenszel|||||2.50|1.44|<.0001
72403877|NCT00082433|144313920|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||Wei-Lachin|||There was a statistically significant difference between groups in change from baseline FBSI score favoring capecitabine. A mean change from baseline of 2.5 was considered a clinically meaningful difference (minimally important difference or MID). On-treatment mean changes in the FBSI did not reach the MID in either group.||||<0.0001
72403878|NCT00082433|144313921|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.9||||0.1162||95.0|0.78|1.03||The test was stratified by (taxane resistance \[yes/no\], measurable disease versus non-measurable disease, prior chemotherapy for metastatic disease \[yes/no\], and anthracycline resistance \[yes/no\]).|Log Rank|The analysis was conducted at the 0.05 level and no adjustments were performed||This primary analysis was a comparison between the 2 treatment arms using a 2-sided, α=0.05 level log-rank test (to reject the null hypothesis of equality of survival). The analysis was conducted when 880 deaths (430 in combination:450 in capecitabine) were observed from the 1221 randomized participants.||1.03|.78|.1162
72403879|NCT00082433|144313921|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.85||||0.0231||95.0|0.75|0.98|||Regression, Cox|||This prespecified secondary analysis was a Cox model adjusted for age, Karnofsky performance status, number of organ sites, estrogen receptor status, hepatic impairment, time from diagnosis, liver/lung metastases.||.98|.75|.0231
72515547|NCT03519516|144562047|NON_INFERIORITY|it is considered as noninferiority if there is no difference greater than twenty percent between both medications||||||0.495|||||||Wilcoxon (Mann-Whitney)|||||||0.495
72515548|NCT03519516|144562048|NON_INFERIORITY|it is considered as noninferiority if there is no difference greater than twenty percent between both medications||||||0.492||||||statistical analysis between groups for final visit with green lissamine|Chi-squared|||||||0.492
72488326|NCT01431274|144505151|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.077|STANDARD_ERROR_OF_MEAN|0.024||0.0017|TWO_SIDED|95.0|0.029|0.125||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within-patient errors."|||0.125|0.029|0.0017
72488327|NCT01431274|144505151|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.138|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001|TWO_SIDED|95.0|0.09|0.186||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Tiotropium (5 μg).~Spatial power covariance structure for within-patient errors."|||0.186|0.090|<0.0001
72488328|NCT01431274|144505151|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.05|STANDARD_ERROR_OF_MEAN|0.024||0.0426|TWO_SIDED|95.0|0.002|0.098||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within-patient errors."|||0.098|0.002|0.0426
72488329|NCT01431274|144505151|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.122|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001||95.0|0.074|0.17||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.170|0.074|<0.0001
72488330|NCT01431274|144505151|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.111|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001|TWO_SIDED|95.0|0.063|0.159||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (5 µg).~Spatial power covariance structure for within-patient errors."|||0.159|0.063|<0.0001
72488331|NCT01431274|144505151|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.027|STANDARD_ERROR_OF_MEAN|0.025||0.2661|TWO_SIDED|95.0|-0.021|0.075||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tio+Olo FDC (2.5/5 µg).~Spatial power covariance structure for within-patient errors."|||0.075|-0.021|0.2661
72488332|NCT01431274|144505151|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.15|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001|TWO_SIDED|95.0|0.102|0.198||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.198|0.102|<0.0001
72488333|NCT01431274|144505151|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.061|STANDARD_ERROR_OF_MEAN|0.024||0.0119|TWO_SIDED|95.0|-0.109|-0.014||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within-patient errors."|||-0.014|-0.109|0.0119
72488334|NCT01431274|144505151|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.073|STANDARD_ERROR_OF_MEAN|0.024||0.0029|TWO_SIDED|95.0|-0.121|-0.025||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (2.5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within-patient errors."|||-0.025|-0.121|0.0029
72515549|NCT03519516|144562048|NON_INFERIORITY|it is considered as noninferiority if there is no difference greater than twenty percent between both medications||||||0.238||||||statistical analysis between groups for final visit with fluorescein|Chi-squared, Corrected|||||||0.238
72515550|NCT03519516|144562049|NON_INFERIORITY|it is considered as noninferiority if there is no difference greater than twenty percent between both medications||||||0.213|||||||Chi-squared|||||||0.213
72515551|NCT03519516|144562051|NON_INFERIORITY|it is considered as noninferiority if there is no difference greater than twenty percent between both medications||||||0.741|||||||Chi-squared, Corrected|||||||0.741
72515552|NCT03519516|144562053|NON_INFERIORITY|The study drug is considered non-inferior with respect to the comparator if there are no differences above twenty percent||||||0.11|||||||Wilcoxon (Mann-Whitney)|||||||0.110
72515553|NCT00321269|144562058|SUPERIORITY_OR_OTHER|||||||0.9|TWO_SIDED||||||Mixed Models Analysis|||Mixed effects regression analysis- Treatment Arm X Time F (2, 116)=0.09, P\>F=0.90.||||0.90
72515554|NCT00321269|144562059|SUPERIORITY_OR_OTHER|||||||0.13|TWO_SIDED||||||Mixed Models Analysis|F(2,110)=2.08; P=0.13||||||0.13
72568472|NCT01030341|144668310|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Mean change = 0|||||<|0.0001|||||||paired t-test|||Null hypothesis: No difference in total GCSI score from screening to 24 weeks of treatment.||||<0.0001
72515555|NCT03337139|144562060|SUPERIORITY|||||||0.98||||||A priori threshold for statistical significance was p \<.05.|ANCOVA|||Comparing groups on 13 week weight loss, prior to randomization.||||.98
72515556|NCT03337139|144562060|SUPERIORITY|||||||0.75||||||A priori threshold for statistical significance was p \<.05.|ANCOVA|Controlling for Phase I weight loss||Comparing groups on 26 week weight loss||||.75
72515557|NCT03337139|144562060|SUPERIORITY|||||||0.02||||||A priori threshold for statistical significance was p\<.05.|ANCOVA|Controlling for Phase I weight loss||Comparing groups on 52 week weight loss||||.02
72488335|NCT01431274|144505151|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.011|STANDARD_ERROR_OF_MEAN|0.024||0.6408|TWO_SIDED|95.0|-0.036|0.059||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.059|-0.036|0.6408
72488336|NCT01431274|144505152|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.221|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.173|0.27||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within-patient errors."|||0.270|0.173|<0.0001
72488337|NCT01431274|144505152|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.193|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.145|0.242||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Tiotropium (5 μg).~Spatial power covariance structure for within-patient errors."|||0.242|0.145|<0.0001
72488338|NCT01431274|144505152|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.185|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.136|0.233||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within-patient errors."|||0.233|0.136|<0.0001
72515558|NCT03337139|144562061|SUPERIORITY|||||||0.12||||||A priori threshold for statistical significance was p \<.05.|ANCOVA|||Comparing groups on 13 week MVPA||||.12
72515559|NCT03337139|144562061|SUPERIORITY|||||||0.16||||||A priori threshold for statistical significance was p\<.05.|ANCOVA|Controlling for changes in Phase I MVPA||Comparing groups on 52 week MVPA||||.16
72515560|NCT03337139|144562062|SUPERIORITY|||||||0.43||||||A priori threshold for statistical significant was p\<.05.|Fisher Exact|||Comparing groups on 26 week retention rates||||.43
72515561|NCT03337139|144562062|SUPERIORITY|||||||0.48||||||A priori threshold for statistical significance was p\<.05.|Fisher Exact|||Comparing groups on 52 week retention rates.||||.48
72515562|NCT03337139|144562063|SUPERIORITY|||||||0.64||||||A priori threshold of statistical significance was p\<.05.|Permutation test|Permutation test (nonparametric test) was chosen due to the violation of t-test assumptions in the data set.||Comparing groups on phone calls completed in Phase II (52 weeks)||||.64
72515563|NCT03337139|144562063|SUPERIORITY|||||||0.499||||||A priori threshold for statistical significance was p\<.05.|Permutation test|Permutation test (nonparametric test) was chosen due to the violation of t-test assumptions in the data set.||Comparing groups on text messages completed in Phase II (52 weeks)||||.499
72515564|NCT03337139|144562064|SUPERIORITY|||||||0.86||||||A priori threshold for statistical significance was p\<.05.|Permutation test|Permutation test (nonparametric test) was chosen due to the violation of t-test assumptions in the data set.||Comparing groups on TAQ scores at 52 weeks||||.86
72515565|NCT03337139|144562065|SUPERIORITY|||||||0.002||||||A priori threshold for statistical significance was p\<.05.|ANCOVA|Controlling for Phase I engagement in self-monitoring||Comparing groups on percent days of self-monitoring of weight during Phase II||||.002
72568473|NCT01030341|144668310|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Mean change = 0|||||<|0.0001|||||||paired t-test|||Null hypothesis: No difference in GCSI composite score from screening to 12 weeks of treatment.||||<0.0001
72515566|NCT03337139|144562065|SUPERIORITY|||||||0.001||||||A priori threshold for statistical significance was p\<.05.|ANCOVA|Controlling for Phase I engagement in self-monitoring||Comparing groups on percent days of self-monitoring of eating during Phase II||||.001
72515567|NCT03337139|144562065|SUPERIORITY|||||||0.25||||||A priori threshold for statistical significance was p\<.05.|ANCOVA|Controlling for Phase I engagement in self-monitoring||Comparing groups on percent days of self-monitoring of physical activity during Phase II||||.25
72515568|NCT03337139|144562066|SUPERIORITY|||||||0.005||||||A priori threshold for statistical significance was p\<.05.|ANCOVA|Controlling for Phase I perceived supportive accountability||Comparing groups on changes in perceived accountability during Phase II||||.005
72515569|NCT04656418|144562136|OTHER|Test for differences|||||<|0.001||||||Compared the time-normalized number of HAE attacks in the active and placebo arms by using a two-sided Wilcoxon test (Hierarchical Testing H01) at alpha = 5%.|Two-sided Wilcoxon test|||||||<0.001
72515570|NCT04656418|144562137|OTHER|Test for differences|||||<|0.001||||||Compared the time-normalized number of HAE attacks in the active and placebo arms by using a two-sided Wilcoxon test.|Two-sided Wilcoxon test|||6 Months of treatment||||<0.001
72515571|NCT04656418|144562138|OTHER|Test for differences|||||<|0.001||||||Tested the differences between the active and placebo arms using a two-sided Wilcoxon test at alpha = 5%.|Two-sided Wilcoxon test|||6 Months of treatment||||<0.001
72488339|NCT01431274|144505152|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.114|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.065|0.162||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.162|0.065|<0.0001
72488340|NCT01431274|144505152|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.157|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.108|0.205||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (5 µg).~Spatial power covariance structure for within-patient errors."|||0.205|0.108|<0.0001
72488341|NCT01431274|144505152|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.037|STANDARD_ERROR_OF_MEAN|0.025||0.1355|TWO_SIDED|95.0|-0.012|0.085||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tio+Olo FDC (2.5/5 µg).~Spatial power covariance structure for within-patient errors."|||0.085|-0.012|0.1355
72488342|NCT01431274|144505152|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.151|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.102|0.199||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.199|0.102|<0.0001
72488343|NCT01431274|144505152|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.028|STANDARD_ERROR_OF_MEAN|0.025||0.2562|TWO_SIDED|95.0|-0.02|0.076||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within-patient errors."|||0.076|-0.020|0.2562
72488344|NCT01431274|144505152|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.071|STANDARD_ERROR_OF_MEAN|0.025||0.0041|TWO_SIDED|95.0|0.022|0.119||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (2.5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within-patient errors."|||0.119|0.022|0.0041
72488345|NCT01431274|144505152|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.043|STANDARD_ERROR_OF_MEAN|0.025||0.0815|TWO_SIDED|95.0|-0.091|0.005||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.005|-0.091|0.0815
72488346|NCT01431274|144505153|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.195|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001|TWO_SIDED|95.0|0.149|0.242||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within-patient errors."|||0.242|0.149|<0.0001
72488347|NCT01431274|144505153|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.153|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001|TWO_SIDED|95.0|0.107|0.199||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Tiotropium (5 μg).~Spatial power covariance structure for within-patient errors."|||0.199|0.107|<0.0001
72488348|NCT01431274|144505153|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.174|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001|TWO_SIDED|95.0|0.128|0.221||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within-patient errors."|||0.221|0.128|<0.0001
72515572|NCT04656418|144562138|OTHER|Test for differences|||||<|0.001||||||Tested the differences between the active and placebo arms using a two-sided Wilcoxon test at alpha = 5%.|Two-sided Wilcoxon test|||First 3-months of treatment||||<0.001
72515573|NCT04656418|144562138|OTHER|Test for differences|||||<|0.001||||||Tested the differences between the active and placebo arms using a two-sided Wilcoxon test at alpha = 5%.|Two-sided Wilcoxon test|||Second 3-months of treatment||||<0.001
72515574|NCT04656418|144562139|OTHER|Test for differences|||||<|0.001||||||Tested the differences between the active and placebo arms using a two-sided Wilcoxon test at alpha = 5%.|Two-sided Wilcoxon test|||6 Months of treatment||||<0.001
72515575|NCT04656418|144562139|OTHER|Test for differences|||||<|0.001||||||Tested the differences between the active and placebo arms using a two-sided Wilcoxon test at alpha = 5%.|Two-sided Wilcoxon test|||First 3-months of treatment||||<0.001
72515576|NCT04656418|144562139|OTHER|Test for differences|||||<|0.001||||||Tested the differences between the active and placebo arms using a two-sided Wilcoxon test at alpha = 5%.|Two-sided Wilcoxon test|||Second 3-months of treatment||||<0.001
72515577|NCT04656418|144562140|OTHER|Test for differences|||||<|0.001||||||Tested the differences between the active and placebo arms using a two-sided Wilcoxon test at alpha = 5%.|Two-sided Wilcoxon test|||First 3-months of treatment||||<0.001
72488349|NCT01431274|144505153|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.107|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001|TWO_SIDED|95.0|0.061|0.154||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.154|0.061|<0.0001
72488350|NCT01431274|144505153|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.132|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001|TWO_SIDED|95.0|0.086|0.178||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (5 µg).~Spatial power covariance structure for within-patient errors."|||0.178|0.086|<0.0001
72488351|NCT01431274|144505153|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.021|STANDARD_ERROR_OF_MEAN|0.024||0.3727|TWO_SIDED|95.0|-0.025|0.067||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tio+Olo FDC (2.5/5 µg).~Spatial power covariance structure for within-patient errors."|||0.067|-0.025|0.3727
72488352|NCT01431274|144505153|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.128|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001|TWO_SIDED|95.0|0.082|0.175||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.175|0.082|<0.0001
72488353|NCT01431274|144505153|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.042|STANDARD_ERROR_OF_MEAN|0.024||0.0744|TWO_SIDED|95.0|-0.004|0.089||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within-patient errors."|||0.089|-0.004|0.0744
72488354|NCT01431274|144505153|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.067|STANDARD_ERROR_OF_MEAN|0.024||0.0047|TWO_SIDED|95.0|0.021|0.114||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (2.5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within-patient errors."|||0.114|0.021|0.0047
72488355|NCT01431274|144505153|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.025|STANDARD_ERROR_OF_MEAN|0.024||0.2945|TWO_SIDED|95.0|-0.071|0.022||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.022|-0.071|0.2945
72488356|NCT01431274|144505154|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.205|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.155|0.255||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within-patient errors."|||0.255|0.155|<0.0001
72515578|NCT04656418|144562140|OTHER|Test for differences|||||<|0.001||||||Tested the differences between the active and placebo arms using a two-sided Wilcoxon test at alpha = 5%.|Two-sided Wilcoxon test|||Second 3-months of treatment||||<0.001
72515579|NCT04656418|144562141|OTHER|Test for differences|||||<|0.001||||||Compared the time-normalized number of HAE attacks in the active and placebo arms by using a two-sided Wilcoxon test (Hierarchical testing H02) at alpha = 5%.|Two-sided Wilcoxon test|||||||<0.001
72515580|NCT00751179|144562188|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Significance level was set at 0.05.|ANOVA|||Treatment comparison was between the change from baseline in potassium level post-rocuronium dose versus post-succinylcholine dose, using a one way ANOVA model, with treatment as the term in the model.||||<0.0001
72403880|NCT04477304|144313942|SUPERIORITY||Mean Difference (Net)|-0.09|STANDARD_ERROR_OF_MEAN|0.01|<|0.001|TWO_SIDED|95.0|-0.12|-0.07||The threshold for statistical significance was p = 0.05|Mixed Models Analysis|Left-Censored Tobit Regression||Assuming a clinic-level intraclass correlation of 0.01, alpha 0.025, 86 clinics, and 5.5 clinicians per-clinic (N = 473), it was calculated we would have over 85% power for a one-tailed test detecting a 12% reduction in MME from baseline to intervention.||-0.07|-0.12|<0.001
72515581|NCT00751179|144562189|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Significance level was set at 0.05.|ANOVA|||Treatment comparison was between the change from baseline in potassium level post-rocuronium dose versus post-succinylcholine dose, using a one way ANOVA model, with treatment as the term in the model.||||<0.0001
72515582|NCT00751179|144562191|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Significance level was set at 0.05.|ANOVA|||Treatment comparison was between the change from baseline in potassium level post-rocuronium dose versus post-succinylcholine dose, using a one way ANOVA model, with treatment as the term in the model.||||<0.0001
72515583|NCT00751179|144562193|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Significance level was set at 0.05.|ANOVA|||Treatment comparison was between the change from baseline in potassium level post-rocuronium dose versus post-succinylcholine dose, using a one way ANOVA model, with treatment as the term in the model.||||<0.0001
72403881|NCT04477304|144313943|SUPERIORITY||Mean Difference (Net)|-0.19|STANDARD_ERROR_OF_MEAN|0.02|<|0.001|TWO_SIDED|95.0|-0.23|-0.16||The threshold for statistical significance was p = 0.05.|Mixed Models Analysis|Left-Censored Tobit Regression||Assuming a clinic-level intraclass correlation of 0.01, alpha 0.025, 86 clinics, and 5.5 clinicians per-clinic (N = 473), it was calculated we would have over 85% power for a one-tailed test detecting a 12% reduction in MME from baseline to intervention.||-0.16|-0.23|<0.001
72488357|NCT01431274|144505154|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.156|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.107|0.206||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Tiotropium (5 μg).~Spatial power covariance structure for within-patient errors."|||0.206|0.107|<0.0001
72488358|NCT01431274|144505154|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.192|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.142|0.242||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within-patient errors."|||0.242|0.142|<0.0001
72515584|NCT00915538|144562223|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The expected results for non-inferiority would be +/- 5% of difference between the two groups in the primary efficacy parameter.|AUC|0.0||||0.76|TWO_SIDED||||||t-test, 2 sided|||The cross-over means there were 16 determinants for each time for each treatment. The AUC of FEV-1 was measured in each subject for each treatment arm and the mean of this data was compared.||||0.76
72515585|NCT00915538|144562223|OTHER|Two sample T test|Mean Difference (Net)|0.0|STANDARD_DEVIATION|12.0|>|0.05|TWO_SIDED||||||t-test, 2 sided|||||||>.05
72515586|NCT00915538|144562224|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Power calculation was not done for secondary parameter. The comparison was for the FEV-1/FVC expressed as fraction at each time point||||||0.76|TWO_SIDED|95.0|||||t-test, 2 sided|||The cross over means there were 16 determinants for each time for each treatment||||0.76
72515587|NCT01093755|144562245|SUPERIORITY_OR_OTHER|||||||0.3|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Comparison between the two treatment groups at 3 months||||0.30
72515588|NCT01093755|144562245|SUPERIORITY_OR_OTHER|||||||0.52|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Comparison between the two treatment groups at 6 months||||0.52
72515589|NCT01093755|144562246|SUPERIORITY_OR_OTHER|||||||0.7|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Comparison between the two treatment groups at 3 months||||0.70
72515590|NCT01093755|144562246|SUPERIORITY_OR_OTHER|||||||0.64|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Comparison between the two treatment groups at 6 months||||0.64
72515591|NCT02307838|144562247|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.59||||0.0155|TWO_SIDED|95.0|-1.07|-0.11|||ANCOVA|||||-0.11|-1.07|0.0155
72515592|NCT03372603|144562295|OTHER||Ratio|1.336|||||TWO_SIDED|90.0|0.965|1.847|||||Treatment comparison ratio of GSK2798745 and placebo using posterior median ratio and 90% credible interval is presented.|||1.847|0.965|
72515593|NCT02806947|144562314|OTHER|No formal hypothesis test was planned or performed for comparing Day 28 CR/PR proportions between arms. Rather, the risk difference is estimated by a point estimate and 90% confidence interval.|Risk Difference (RD)|-0.082|STANDARD_ERROR_OF_MEAN|0.086|||TWO_SIDED|90.0|-0.223|0.059|||||The risk difference estimate is the observed proportion of Day 28 CR/PR in the sirolimus arm minus the proportion in the prednisone arm. A Wald confidence interval for this difference is given.|The primary objective of this Phase II trial was to describe the proportion of patients with Day 28 CR/PR in each treatment arm and to estimate the risk difference of these rates using a point estimate and 90% confidence interval. These estimates are used to inform about the efficacy of sirolimus in contrast to prednisone for potential future research.||0.059|-0.223|
72515594|NCT02806947|144562314|OTHER|No formal hypothesis test was planned or performed for comparing Day 56 CR/PR proportions between arms. Rather, the risk difference is estimated by a point estimate and 95% confidence interval.|Risk Difference (RD)|-0.152|STANDARD_ERROR_OF_MEAN|0.083|||TWO_SIDED|95.0|-0.315|0.011|||||The risk difference estimate is the observed proportion of Day 56 CR/PR in the sirolimus arm minus the proportion in the prednisone arm. A Wald confidence interval for this difference is given.|A secondary objective of this Phase II trial was to describe the proportion of patients with Day 56 CR/PR in each treatment arm and to estimate the risk difference of these rates using a point estimate and 95% confidence interval. These estimates are used to inform about the efficacy of sirolimus in contrast to prednisone for potential future research.||0.011|-0.315|
72515595|NCT02806947|144562315|SUPERIORITY||||||<|0.001||||||Statistical significance was determined using a pre-specified threshold of 0.05|Z test comparing binomial proportions|||The null hypothesis is that there is no difference in the proportions of participants with CR/PR and steroid dose of 0.25mg/kg/day or less at Day 28 post-randomization between the sirolimus and prednisone arms. These proportions were compared between treatment arms using a Z test of the difference of binomial proportions.||||< 0.001
72515596|NCT02806947|144562316|SUPERIORITY|||||||0.32||||||Statistical significance was determined using a pre-specified threshold of 0.05|Fisher Exact|||The null hypothesis is that there is no difference in classification of acute GVHD response at Day 28 post-randomization between participants on the sirolimus and prednisone arms. These classifications were compared between treatment arms using Fisher's exact test, due to the presence of small numbers of participants in some categories.||||0.320
72568474|NCT01030341|144668310|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Mean change = 0|||||<|0.0001|||||||paired t-test|||Null hypothesis: No difference in GCSI composite score from screening to 24 weeks of treatment.||||<0.0001
72568475|NCT01030341|144668310|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Mean change = 0|||||<|0.0001|||||||paired t-test|||Null hypothesis: No difference in PAGI-QOL score from screening to 12 weeks of treatment.||||<0.0001
72488359|NCT01431274|144505154|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.124|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.074|0.174||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.174|0.074|<0.0001
72488360|NCT01431274|144505154|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.144|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.094|0.193||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (5 µg).~Spatial power covariance structure for within-patient errors."|||0.193|0.094|<0.0001
72488361|NCT01431274|144505154|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.013|STANDARD_ERROR_OF_MEAN|0.025||0.6103|TWO_SIDED|95.0|-0.037|0.062||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tio+Olo FDC (2.5/5 µg).~Spatial power covariance structure for within-patient errors."|||0.062|-0.037|0.6103
72488362|NCT01431274|144505154|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.137|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.087|0.186||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.186|0.087|<0.0001
72624284|NCT00863304|144778627|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.15|STANDARD_ERROR_OF_MEAN|0.24|<|0.001|TWO_SIDED|95.0|-1.63|-0.68||P-value was based on pairwise comparisons.|ANCOVA|||Week 12: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.68|-1.63|<0.001
72488363|NCT01431274|144505154|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.049|STANDARD_ERROR_OF_MEAN|0.025||0.0559|TWO_SIDED|95.0|-0.001|0.098||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within-patient errors."|||0.098|-0.001|0.0559
72403882|NCT04477304|144313944|SUPERIORITY||Mean Difference (Net)|-0.08|STANDARD_ERROR_OF_MEAN|0.01|<|0.001|TWO_SIDED|95.0|-0.1|-0.06||The threshold for statistical significance was p = 0.05|Mixed Models Analysis|||Assuming a clinic-level intraclass correlation of 0.01, alpha 0.025, 86 clinics, and 5.5 clinicians per-clinic (N = 473), it was calculated we would have over 85% power for a one-tailed test detecting a 12% reduction in MME from baseline to intervention.||-0.06|-0.10|<0.001
72568476|NCT01030341|144668310|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Mean change = 0|||||<|0.0001|||||||paired t-test|||Null hypothesis: No difference in PAGI-QOL score from screening to 24 weeks of treatment.||||<0.0001
72568477|NCT01196078|144668342|SUPERIORITY_OR_OTHER||Difference in Percentages|13.88||||0.0388|TWO_SIDED|95.0|-0.22|26.19||Between-treatment difference computed using logistic regression with treatment and multiple factors (gender, Eastern Cooperative Oncology Group \[ECOG\] status, histology status, and smoking status) as explanatory variables.|Regression, Logistic||95% confidence interval (CI) for the difference in tumor response rate determined using Hauck-Anderson approach.|||26.19|-0.22|0.0388
72488364|NCT01431274|144505154|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.068|STANDARD_ERROR_OF_MEAN|0.025||0.0073|TWO_SIDED|95.0|0.018|0.118||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (2.5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within-patient errors."|||0.118|0.018|0.0073
72568478|NCT01196078|144668343|SUPERIORITY_OR_OTHER||Difference in Percentages|14.79||||0.1061|TWO_SIDED|95.0|-3.54|31.33||Between-treatment difference computed using logistic regression with treatment and multiple factors (gender, ECOG status, histology status, and smoking status) as explanatory variables.|Regression, Logistic||95% CI for the difference in the disease control rate determined using Hauck-Anderson approach.|||31.33|-3.54|0.1061
72568479|NCT01196078|144668344|SUPERIORITY_OR_OTHER|||||||0.9505|||||||Log Rank|||||||0.9505
72568480|NCT01196078|144668346|SUPERIORITY_OR_OTHER|||||||0.2314|||||||Log Rank|Data were stratified by gender, ECOG status, histology status, and smoking status.||||||0.2314
72568481|NCT01196078|144668348|SUPERIORITY_OR_OTHER|||||||0.9894|||||||Log Rank|Data were stratified by gender, ECOG status, histology status, and smoking status.||||||0.9894
72568482|NCT01196078|144668350|SUPERIORITY_OR_OTHER|||||||0.006|||||||ANOVA|||PWB, Baseline versus Endpoint||||0.0060
72568483|NCT01196078|144668350|SUPERIORITY_OR_OTHER|||||||0.6871|||||||ANOVA|||SWB, Baseline versus Endpoint||||0.6871
72568484|NCT01196078|144668350|SUPERIORITY_OR_OTHER|||||||0.5104|||||||ANOVA|||EWB Baseline versus Endpoint||||0.5104
72568485|NCT01196078|144668350|SUPERIORITY_OR_OTHER|||||||0.9927|||||||ANOVA|||FWB, Baseline versus Endpoint||||0.9927
72568486|NCT01196078|144668350|SUPERIORITY_OR_OTHER|||||||0.3581|||||||ANOVA|||LCS, Baseline versus Endpoint||||0.3581
72568487|NCT00270257|144668362|SUPERIORITY_OR_OTHER_LEGACY||Incident rate per 100 person-years|1.5|||||TWO_SIDED|95.0|0.7|2.8||||||||2.8|0.7|
72568488|NCT00270257|144668362|SUPERIORITY_OR_OTHER_LEGACY||Incident rate per 100 person-years|2.2|||||TWO_SIDED|95.0|1.2|3.7||||||||3.7|1.2|
72568489|NCT00270257|144668362|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|0.694||||0.3769|TWO_SIDED|95.0|0.308|1.562|||Regression, Cox|||||1.562|0.308|0.3769
72624285|NCT00863304|144778627|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.07|STANDARD_ERROR_OF_MEAN|0.24|<|0.001|TWO_SIDED|95.0|-1.55|-0.6||P-value was based on pairwise comparisons.|ANCOVA|||Week 12: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.60|-1.55|<0.001
72403883|NCT04477304|144313945|SUPERIORITY||Mean Difference (Net)|-0.05|STANDARD_ERROR_OF_MEAN|0.01|<|0.001|TWO_SIDED|95.0|-0.08|-0.03||The threshold for statistical significance was p = 0.05.|Mixed Models Analysis|Left-Censored Tobit Regression||Assuming a clinic-level intraclass correlation of 0.01, alpha 0.025, 86 clinics, and 5.5 clinicians per-clinic (N = 473), it was calculated we would have over 85% power for a one-tailed test detecting a 12% reduction in MME from baseline to intervention.||-0.03|-0.08|<0.001
72403884|NCT04477304|144313946|SUPERIORITY||Mean Difference (Net)|-0.01|STANDARD_ERROR_OF_MEAN|0.01||0.392|TWO_SIDED|95.0|-0.03|-0.01||The threshold for statistical significance was p = 0.05.|Mixed Models Analysis|||Assuming a clinic-level intraclass correlation of 0.01, alpha 0.025, 86 clinics, and 5.5 clinicians per-clinic (N = 473), it was calculated we would have over 85% power for a one-tailed test detecting a 12% reduction in MME from baseline to intervention.||-0.01|-0.03|0.392
72403885|NCT04477304|144313947|SUPERIORITY||Mean Difference (Net)|-0.09|STANDARD_ERROR_OF_MEAN|0.02|<|0.001|TWO_SIDED|95.0|-0.13|-0.05||The threshold for statistical significance was p = 0.05.|Mixed Models Analysis|Left-Censored Tobit Regression||Assuming a clinic-level intraclass correlation of 0.01, alpha 0.025, 86 clinics, and 5.5 clinicians per-clinic (N = 473), it was calculated we would have over 85% power for a one-tailed test detecting a 12% reduction in MME from baseline to intervention.||-0.05|-0.13|<0.001
72403886|NCT03026257|144313975|SUPERIORITY||||||<|0.0001|||||||General Linear Model|||||||<0.0001
72403887|NCT03026257|144313975|SUPERIORITY||||||<|0.0001|||||||General Linear Model|||||||<0.0001
72403888|NCT03026257|144313975|SUPERIORITY||||||<|0.0001|||||||General Linear Model|||||||<0.0001
72403889|NCT03026257|144313975|SUPERIORITY||||||<|0.0001|||||||General Linear Model|||||||<0.0001
72403890|NCT03026257|144313975|SUPERIORITY||||||<|0.0001|||||||General Linear Model|||||||<0.0001
72403891|NCT03026257|144313975|SUPERIORITY||||||<|0.0001|||||||General Linear Model|||||||<0.0001
72403892|NCT03026257|144313975|SUPERIORITY||||||<|0.0001|||||||General Linear Model|||||||<0.0001
72403893|NCT03026257|144313975|SUPERIORITY||||||<|0.0001|||||||General Linear Model|||||||<0.0001
72403894|NCT05083442|144313976|SUPERIORITY||Mean Difference (Net)|0.8||||0.19|TWO_SIDED|95.0|-0.4|1.9|||ANCOVA||Estimated difference between groups from analysis of covariance with baseline fat mass included as the covariate.|Groups were compared using analysis of covariance with baseline included as the covariate.||1.9|-0.4|0.19
72515597|NCT02806947|144562316|SUPERIORITY|||||||0.014||||||Statistical significance was determined using a pre-specified threshold of 0.05|Fisher Exact|||The null hypothesis is that there is no difference in classification of acute GVHD response at Day 56 post-randomization between participants on the sirolimus and prednisone arms. These classifications were compared between treatment arms using Fisher's exact test, due to the presence of small numbers of participants in some categories.||||0.014
72403895|NCT05083442|144313977|SUPERIORITY||Mean Difference (Net)|0.3||||0.745|TWO_SIDED|95.0|-1.5|2.1|||ANCOVA||Estimated difference between groups from analysis of covariance with baseline fat mass included as the covariate.|Groups were compared using analysis of covariance with baseline included as the covariate.||2.1|-1.5|0.745
72403896|NCT00136084|144313999|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.624||||0.1559||95.0|0.832|3.205||The p-value is not adjusted for multiple comparisons. The a priori threshold for statistical significance is 0.041 so that the overall level of the study is maintained at 0.05 across the 4 interim analyses and the final analysis.|Cochran-Mantel-Haenszel|The p-value was computed using a Monte Carlo approximation (10000 permutations) to an exact, risk-group stratified, test.|The odds ratio is defined as the ratio of the odds that a LDAC patient is MRD positive to the odds that a HDAC patient is MRD positive.|The study was designed to test the null hypothesis that HDAC and LDAC result in the same proportion of patients with positive MRD after 22 days. Power calculations indicate that enrollment of a total of 186 MRD-evaluable patients in a 5-stage O'Brien-Fleming group sequential design gives 80% power at the 5% level to detect a change in the MRD-positive proportion from 0.50 to 0.30. The design was developed using East statistical software.||3.205|.832|.1559
72515598|NCT02806947|144562317|SUPERIORITY|||||||0.078||||||Statistical significance was determine using a pre-specified threshold of 0.05|Z test comparing binomial proportions|||The null hypothesis is that there is no difference in the proportions of participants with treatment failure at Day 28 post-randomization between the sirolimus and prednisone arms. These proportions were compared between treatment arms using a Z test of the difference of binomial proportions.||||0.078
72403897|NCT00136084|144314000|SUPERIORITY_OR_OTHER||Binomial proportion|0.733||||||95.0|0.449|0.922|||Binomial proportion|||Estimate of the proportion of negative minimal residual disease.||.922|.449|
72403898|NCT00136084|144314001|SUPERIORITY_OR_OTHER||Binomial proportion|0.931||||||95.0|0.772|0.992|||Binomial proportion|||||.992|.772|
72403899|NCT00136084|144314002|SUPERIORITY_OR_OTHER||Binomial proportion|0.9||||||95.0|0.735|0.979|||Binomial proportion|||||.979|.735|
72403900|NCT00136084|144314004|SUPERIORITY_OR_OTHER|||||||0.6||95.0|||||t-test, 2 sided|||||||0.60
72403901|NCT00136084|144314005|SUPERIORITY_OR_OTHER||Odds Ratio, log|-0.0139||||0.2287|TWO_SIDED|95.0|-0.0365|0.00873|||Regression, Logistic|||||0.00873|-0.0365|0.2287
72403902|NCT01344447|144314042|SUPERIORITY_OR_OTHER||Percentage difference|22.3|||<|0.0001|TWO_SIDED|95.1|20.4||Not Appropriate, upper intervals were not used in the statistical analysis and were not of interest for the study.||McNemar|Cluster adjusted McNemar||Majority reader; Superiority analysis; The percentage difference was calculated as gadobutrol-enhanced minus unenhanced MRA.|||20.4|<0.0001
72403903|NCT01344447|144314042|SUPERIORITY_OR_OTHER||Percentage difference|63.8|||<|0.0001|TWO_SIDED|95.1|60.9||Not Appropriate, upper intervals were not used in the statistical analysis and were not of interest for the study.||McNemar|Cluster adjusted McNemar||Blinded reader 1; Superiority analysis; The percentage difference was calculated as gadobutrol-enhanced minus unenhanced MRA.|||60.9|<0.0001
72403904|NCT01344447|144314042|SUPERIORITY_OR_OTHER||Percentage difference|19.6|||<|0.0001|TWO_SIDED|95.1|17.8||Not Appropriate, upper intervals were not used in the statistical analysis and were not of interest for the study.||McNemar|Cluster adjusted McNemar||Blinded reader 2; Superiority analysis; The percentage difference was calculated as gadobutrol-enhanced minus unenhanced MRA.|||17.8|<0.0001
72515599|NCT02806947|144562317|SUPERIORITY|||||||0.068||||||Statistical significance was determined using a pre-specified threshold of 0.05|Z test comparing binomial proportions|||The null hypothesis is that there is no difference in the proportions of participants with treatment failure at Day 56 post-randomization between the sirolimus and prednisone arms. These proportions were compared between treatment arms using a Z test of the difference of binomial proportions.||||0.068
72403905|NCT01344447|144314042|SUPERIORITY_OR_OTHER||Percentage difference|15.0|||<|0.0001|TWO_SIDED|95.1|13.3||Not Appropriate, upper intervals were not used in the statistical analysis and were not of interest for the study.||McNemar|Cluster adjusted McNemar||Blinded reader 3; Superiority analysis; The percentage difference was calculated as gadobutrol-enhanced minus unenhanced MRA.|||13.3|<0.0001
72403906|NCT01344447|144314042|SUPERIORITY_OR_OTHER||Percentage difference|18.5|||<|0.0001|TWO_SIDED|95.1|16.5||Not Appropriate, upper intervals were not used in the statistical analysis and were not of interest for the study.||McNemar|Cluster adjusted McNemar||Clinical investigator; Superiority analysis; The percentage difference was calculated as gadobutrol-enhanced minus unenhanced MRA.|||16.5|<0.0001
72403907|NCT01344447|144314043|NON_INFERIORITY_OR_EQUIVALENCE|using a -7.5% non-inferiority margin|Percentage difference|5.7|||||TWO_SIDED|95.1|-3.6||Not Appropriate, upper intervals were not used in the statistical analysis and were not of interest for the study.||The cluster-adjusted two-sided 95% CI|||Majority reader; The percentage difference was calculated as gadobutrol-enhanced minus unenhanced MRA.|||-3.6|
72403908|NCT01344447|144314043|NON_INFERIORITY_OR_EQUIVALENCE|using a -7.5% non-inferiority margin|Percentage difference|5.1|||||TWO_SIDED|95.1|-5.4||Not Appropriate, upper intervals were not used in the statistical analysis and were not of interest for the study.||The cluster-adjusted two-sided 95% CI|||Blinded reader 1; the percentage difference was calculated as gadobutrol-enhanced minus unenhanced MRA.|||-5.4|
72488365|NCT01431274|144505154|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.02|STANDARD_DEVIATION|0.025||0.4368|TWO_SIDED|95.0|-0.07|0.03||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.030|-0.070|0.4368
72488366|NCT01431274|144505155|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.147|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.098|0.196||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within-patient errors."|||0.196|0.098|<0.0001
72488367|NCT01431274|144505155|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.076|STANDARD_ERROR_OF_MEAN|0.025||0.0023|TWO_SIDED|95.0|0.027|0.125||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Tiotropium (5 μg).~Spatial power covariance structure for within-patient errors."|||0.125|0.027|0.0023
72515600|NCT02806947|144562318|SUPERIORITY|||||||0.785||||||Statistical significance was determined using a pre-specified threshold of 0.05|Log Rank|||The null hypothesis is that there is no difference in the proportions of participants with overall survival between the sirolimus and prednisone arms during the 12 month period post-randomization. These proportions were compared between treatment arms using a log rank test.||||0.785
72515601|NCT02806947|144562319|SUPERIORITY|||||||0.34||||||Statistical significance was determined using a pre-specified threshold of 0.05|Log Rank|||The null hypothesis is that there is no difference in the proportions of participants with disease-free survival between the sirolimus and prednisone arms during the 12 month period post-randomization. These proportions were compared between treatment arms using a log rank test.||||0.340
72515602|NCT02806947|144562320|SUPERIORITY|||||||0.713||||||Statistical significance was determined using a pre-specified threshold of 0.05|Log Rank|||The null hypothesis is that there is no difference in the proportions of participants with event-free survival between the sirolimus and prednisone arms during the 12 month period post-randomization. These proportions were compared between treatment arms using a log rank test.||||0.713
72515603|NCT02806947|144562321|SUPERIORITY|||||||0.726||||||Statistical significance was determined using a pre-specified threshold of 0.05|Gray's test|||The null hypothesis is that there is no difference in the proportions of participants with non-relapse mortality between the sirolimus and prednisone arms during the 12 month period post-randomization, with malignancy relapse treated as a competing risk for non-relapse mortality. These proportions were compared between treatment arms using Gray's test.||||0.726
72515604|NCT02806947|144562322|SUPERIORITY|||||||0.402||||||Statistical significance was determined using a pre-specified threshold of 0.05|Gray's test|||The null hypothesis is that there is no difference in the proportions of participants with malignancy relapse between the sirolimus and prednisone arms during the 12 month period post-randomization, with death treated as a competing risk for malignancy relapse. These proportions were compared between treatment arms using Gray's test.||||0.402
72568490|NCT00270257|144668363|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.844||||0.4325|TWO_SIDED|95.0|0.553|1.289||P value applies for the comparison at visit 104.|Regression, Logistic|adjusted for site||||1.289|0.553|0.4325
72403909|NCT01344447|144314043|NON_INFERIORITY_OR_EQUIVALENCE|using a -7.5% non-inferiority margin|Percentage difference|5.1|||||TWO_SIDED|95.1|-4.7||Not Appropriate, upper intervals were not used in the statistical analysis and were not of interest for the study.||The cluster-adjusted two-sided 95% CI|||Blinded reader 2; the percentage difference was calculated as gadobutrol-enhanced minus unenhanced MRA.|||-4.7|
72403910|NCT01344447|144314043|NON_INFERIORITY_OR_EQUIVALENCE|using a -7.5% non-inferiority margin|Percentage difference|3.2|||||TWO_SIDED|95.1|-5.9||Not Appropriate, upper intervals were not used in the statistical analysis and were not of interest for the study.||The cluster-adjusted two-sided 95% CI|||Blinded reader 3; the percentage difference was calculated as gadobutrol-enhanced minus unenhanced MRA.|||-5.9|
72403911|NCT01344447|144314043|NON_INFERIORITY_OR_EQUIVALENCE|using a -7.5% non-inferiority margin|Percentage difference|21.5|||||TWO_SIDED|95.1|14.1||Not Appropriate, upper intervals were not used in the statistical analysis and were not of interest for the study.||The cluster-adjusted two-sided 95% CI|||Clinical investigator; the percentage difference was calculated as gadobutrol-enhanced minus unenhanced MRA.|||14.1|
72403912|NCT01344447|144314044|NON_INFERIORITY_OR_EQUIVALENCE|using a -7.5% non-inferiority margin|Percentage difference|8.8|||||TWO_SIDED|95.1|7.7||Not Appropriate, upper intervals were not used in the statistical analysis and were not of interest for the study.||The cluster-adjusted two-sided 95% CI|||Majority reader; The percentage difference was calculated as gadobutrol-enhanced minus unenhanced MRA.|||7.7|
72488368|NCT01431274|144505155|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.121|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.072|0.17||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within-patient errors."|||0.170|0.072|<0.0001
72488369|NCT01431274|144505155|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.048|STANDARD_ERROR_OF_MEAN|0.025||0.0545|TWO_SIDED|95.0|-0.001|0.097||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (2.5 μg).~Spatial power covariance structure for within-patient errors."|||0.097|-0.001|0.0545
72488370|NCT01431274|144505155|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.05|STANDARD_ERROR_OF_MEAN|0.025||0.0456|TWO_SIDED|95.0|0.001|0.099||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (5 µg).~Spatial power covariance structure for within-patient errors."|||0.099|0.001|0.0456
72488371|NCT01431274|144505155|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.026|STANDARD_ERROR_OF_MEAN|0.025||0.2949|TWO_SIDED|95.0|-0.023|0.075||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tio+Olo FDC (2.5/5 µg).~Spatial power covariance structure for within-patient errors."|||0.075|-0.023|0.2949
72488372|NCT01431274|144505155|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.074|STANDARD_ERROR_OF_MEAN|0.025||0.0029|TWO_SIDED|95.0|0.025|0.123||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.123|0.025|0.0029
72403913|NCT01344447|144314044|NON_INFERIORITY_OR_EQUIVALENCE|using a -7.5% non-inferiority margin|Percentage difference|30.3|||||TWO_SIDED|95.1|28.6||Not Appropriate, upper intervals were not used in the statistical analysis and were not of interest for the study.||The cluster-adjusted two-sided 95% CI|||Blinded reader 1; the percentage difference was calculated as gadobutrol-enhanced minus unenhanced MRA.|||28.6|
72403914|NCT01344447|144314044|NON_INFERIORITY_OR_EQUIVALENCE|using a -7.5% non-inferiority margin|Percentage difference|9.7|||||TWO_SIDED|95.1|8.5||Not Appropriate, upper intervals were not used in the statistical analysis and were not of interest for the study.||The cluster-adjusted two-sided 95% CI|||Blinded reader 2; the percentage difference was calculated as gadobutrol-enhanced minus unenhanced MRA.|||8.5|
72488373|NCT01431274|144505155|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.071|STANDARD_ERROR_OF_MEAN|0.025||0.0045|TWO_SIDED|95.0|0.022|0.12||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within-patient errors."|||0.120|0.022|0.0045
72488374|NCT01431274|144505155|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.073|STANDARD_ERROR_OF_MEAN|0.025||0.0035|TWO_SIDED|95.0|0.024|0.122||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (2.5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within-patient errors."|||0.122|0.024|0.0035
72488375|NCT01431274|144505155|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.002|STANDARD_ERROR_OF_MEAN|0.025||0.9369|TWO_SIDED|95.0|-0.051|0.047||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.047|-0.051|0.9369
72515605|NCT02806947|144562323|SUPERIORITY|||||||0.296||||||Statistical significance was determined using a pre-specified threshold of 0.05|Gray's test|||The null hypothesis is that there is no difference in the proportions of participants with chronic GVHD between the sirolimus and prednisone arms during the 12 month period post-randomization, with death and malignancy relapse treated as competing risks for chronic GVHD. These proportions were compared between treatment arms using Gray's test.||||0.296
72515606|NCT02806947|144562324|SUPERIORITY|||||||0.936||||||Statistical significance was determined using a pre-specified threshold of 0.05|Z test comparing binomial proportions|||The null hypothesis is that there is no difference in the proportions of participants with GVHD-free survival at 6 months post-randomization between the sirolimus and prednisone arms. These proportions were compared between treatment arms using a Z test of the difference of binomial proportions.||||0.936
72515607|NCT02806947|144562324|SUPERIORITY|||||||0.598||||||Statistical significance was determined using a pre-specified threshold of 0.05|Z test comparing binomial proportions|||The null hypothesis is that there is no difference in the proportions of participants with GVHD-free survival at 6 months post-randomization between the sirolimus and prednisone arms. These proportions were compared between treatment arms using a Z test of the difference of binomial proportions.||||0.598
72403915|NCT01344447|144314044|NON_INFERIORITY_OR_EQUIVALENCE|using a -7.5% non-inferiority margin|Percentage difference|7.6|||||TWO_SIDED|95.1|6.6||Not Appropriate, upper intervals were not used in the statistical analysis and were not of interest for the study.||The cluster-adjusted two-sided 95% CI|||Blinded reader 3; the percentage difference was calculated as gadobutrol-enhanced minus unenhanced MRA.|||6.6|
72488376|NCT01431274|144505156|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.168|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.119|0.217||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within-patient errors."|||0.217|0.119|<0.0001
72488377|NCT01431274|144505156|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.105|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.056|0.154||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Tiotropium (5 μg).~Spatial power covariance structure for within-patient errors."|||0.154|0.056|<0.0001
72488378|NCT01431274|144505156|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.103|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.054|0.152||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within-patient errors."|||0.152|0.054|<0.0001
72515608|NCT02806947|144562325|SUPERIORITY|||||||0.221||||||Statistical significance was determined using a pre-specified threshold of 0.05|Gray's test|||The null hypothesis is that there is no difference in the proportions of participants with serious infections between the sirolimus and prednisone arms during the 12 month period post-randomization, with death treated as a competing risk for serious infection. These proportions were compared between treatment arms using Gray's test.||||0.221
72515609|NCT03641547|144562331|OTHER||Post prob of tox at dose level 6|0.029|||||TWO_SIDED|95.0|0.0|0.165||||||The primary analysis is performed using the Time-To-Event Continual Reassessment Method (TiTE-CRM). Giving posterior estimates for the probability of toxicity (DLT) at each dose level.||0.165|0|
72515610|NCT03641547|144562332|OTHER||Post prob of tox at dose level 4|0.185|||||TWO_SIDED|95.0|0.042|0.397||||||The primary analysis is performed using the Time-To-Event Continual Reassessment Method (TiTE CRM). Giving posterior estimates for the probability of toxicity (DLT) at each dose level.||0.397|0.042|
72515611|NCT00418379|144562343|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|||||||< 0.0001
72515612|NCT00418379|144562343|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|||||||< 0.0001
72515613|NCT00065442|144562344|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.775||||0.032|TWO_SIDED|95.0|0.614|0.979|||Regression, Cox|Cox regression model with treatment, PSA (ln), and LDH (ln) as the independent variables, stratified by randomization strata.|sipuleucel-T/placebo|||0.979|0.614|0.032
72515614|NCT00065442|144562344|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.766||||0.023|TWO_SIDED|95.0|0.608|0.965|||Log Rank|Stratified by randomization strata.|Cox regression model with treatment as the independent variable, stratified by randomization strata (sipuleucel-T/placebo)|||0.965|0.608|0.023
72515615|NCT00065442|144562345|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.951||||0.628|TWO_SIDED|95.0|0.773|1.169|||Log Rank|Stratified by randomization strata|Cox regression model with treatment as the independent variable, stratified by randomization strata|||1.169|0.773|0.628
72515616|NCT03428997|144562374|EQUIVALENCE|Mixed-effects model, where the test material/negative control is a fixed effect and the subject is a random effect|Mean Difference (Final Values)|-0.12|STANDARD_ERROR_OF_MEAN|0.11||0.274|||||||2-sided t-test|||Testing hypothesis is that the mean score is equal between the compared treatments.||||0.274
72515617|NCT00400712|144562396|SUPERIORITY_OR_OTHER|||||||0.44|TWO_SIDED||||||ANCOVA|Examined whether there were differences between groups at 1 year with baseline measures serving as the covariate with a two-sided alpha of 0.05||||||0.44
72515618|NCT00400712|144562397|SUPERIORITY_OR_OTHER|||||||0.83|TWO_SIDED|||||Examined whether there were differences between groups at 1 year with baseline measures serving as the covariate with a two-sided alpha of 0.05|ANCOVA|||||||0.83
72515619|NCT00400712|144562398|SUPERIORITY_OR_OTHER|||||||0.45|TWO_SIDED||||||ANCOVA|||ANCOVA - comparing absolute measures and including baseline as co-variate||||0.45
72515620|NCT00400712|144562399|SUPERIORITY_OR_OTHER|||||||0.72|TWO_SIDED||||||ANCOVA|adjusted for baseline values||||||0.72
72515621|NCT00400712|144562400|SUPERIORITY_OR_OTHER|||||||0.6|TWO_SIDED||||||ANCOVA|controlled for baseline values||||||0.60
72515622|NCT00400712|144562401|SUPERIORITY_OR_OTHER|||||||0.66|TWO_SIDED|||||Examined whether there were differences between groups at 1 year with baseline measures serving as the covariate with a two-sided alpha of 0.05|ANCOVA|||||||0.66
72515623|NCT00400712|144562402|SUPERIORITY_OR_OTHER|||||||0.78|TWO_SIDED|||||Examined whether there were differences between groups at 1 year with baseline measures serving as the covariate with a two-sided alpha of 0.05|ANCOVA|||||||0.78
72515624|NCT01632735|144562414|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.75|||<|0.05|TWO_SIDED|95.0|0.57|0.99|||GEE|Generalized Estimating Equations regression examined primary relapse (measured by urinalysis) over time by condition, controlling for age and gender.||||0.99|0.57|<0.05
72515625|NCT01632735|144562415|SUPERIORITY_OR_OTHER||Beta (timexcondition)|0.239|||<|0.001|TWO_SIDED|95.0|0.219|0.248|||Mixed Models Analysis|Analyses controlled for age and gender.||Mixed modeling using a repeated-measures random-effects model was conducted to test for the effects of treatment (dummy coded with 1 = mobile intervention, 0 = control) and time as well as the treatment x time interaction on the primary outcome measures of recovery behaviors mean days over time (baseline, discharge, 3, 6, and 9-month follow-ups).||0.248|0.219|<0.001
72568491|NCT00270257|144668364|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.8||||0.2749|TWO_SIDED|95.0|0.536|1.194||P value applies for the comparison at visit 104 only.|Regression, Logistic|||||1.194|0.536|0.2749
72488379|NCT01431274|144505156|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.047|STANDARD_ERROR_OF_MEAN|0.025||0.0585|TWO_SIDED|95.0|-0.002|0.096||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.096|-0.002|0.0585
72515626|NCT01632735|144562416|SUPERIORITY_OR_OTHER||Beta (time x condition)|0.115|||<|0.001|TWO_SIDED|95.0|0.106|0.123|||Mixed Models Analysis|A repeated-measures model tested for effects of treatment vs. control on recovery self-confidence over time controlling for age and gender.||Mixed modeling using a repeated-measures random-effects model was conducted to test for the effects of treatment (dummy coded with 1 = mobile intervention, 0 = control) and time as well as the treatment x time interaction on the outcome measure of recovery confidence mean score over time.||0.123|0.106|<0.001
72515627|NCT01632735|144562417|SUPERIORITY_OR_OTHER||Beta effect (timexcondition)|0.217|||<|0.001|TWO_SIDED|95.0|0.2|0.233|||Mixed Models Analysis|Analyses controlled for age and gender.||Mixed modeling using a repeated-measures random-effects model was conducted to test for the effects of treatment (dummy coded with 1 = mobile intervention, 0 = control) and time as well as the treatment x time interaction on the outcome measure of self-help utilization (mean days in past month) over the study period (baseline, discharge, and 3-, 6-, and 9-month follow-ups).||0.233|0.2|<0.001
72515628|NCT03011450|144562491|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<0.0001
72515629|NCT03011450|144562492|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<0.0001
72515630|NCT03011450|144562493|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<0.0001
72515631|NCT03011450|144562494|SUPERIORITY|||||||0.0156|||||||Hodges-Lehmann method|||||||0.0156
72515632|NCT03011450|144562495|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<0.0001
72515633|NCT03011450|144562496|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<0.0001
72515634|NCT03011450|144562497|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<0.0001
72515635|NCT03011450|144562498|SUPERIORITY|||||||0.0001|||||||Hodges-Lehmann method|||||||0.0001
72515636|NCT03011450|144562499|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<0.0001
72515637|NCT03011450|144562500|SUPERIORITY|||||||0.538|||||||Hodges-Lehmann method|||||||0.5380
72515638|NCT03011450|144562501|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<0.0001
72515639|NCT03011450|144562502|SUPERIORITY|||||||0.1165|||||||Hodges-Lehmann method|||||||0.1165
72515640|NCT03011450|144562503|SUPERIORITY|||||||0.0142|||||||Hodges-Lehmann method|||||||0.0142
72515641|NCT03011450|144562504|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<0.0001
72568492|NCT00270257|144668365|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.746||||0.3446|TWO_SIDED|95.0|0.407|1.369||Analysis is done for visit 104|Regression, Logistic|Adjusted for site||||1.369|0.407|0.3446
72515642|NCT03011450|144562505|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<0.0001
72515643|NCT03011450|144562506|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<0.0001
72515644|NCT03011450|144562507|SUPERIORITY|||||||0.4589|||||||Hodges-Lehmann method|||||||0.4589
72515645|NCT03011450|144562508|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<.0001
72515646|NCT03011450|144562509|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<.0001
72515647|NCT03011450|144562510|OTHER||||||<|0.0001|||||||Hodges-Lehmann method|||||||<.0001
72515648|NCT03011450|144562511|SUPERIORITY|||||||0.2486|||||||Hodges-Lehmann method|||||||0.2486
72515649|NCT03011450|144562512|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<.0001
72515650|NCT03011450|144562513|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<.0001
72515651|NCT03011450|144562514|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<.0001
72515652|NCT03011450|144562515|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<.0001
72515653|NCT03011450|144562516|SUPERIORITY|||||||0.0001|||||||Hodges-Lehmann method|||||||0.0001
72515654|NCT03011450|144562517|SUPERIORITY|||||||0.2763|||||||Hodges-Lehmann method|||||||0.2763
72515655|NCT03011450|144562518|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<.0001
72515656|NCT03011450|144562519|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<.0001
72515657|NCT03011450|144562520|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<.0001
72515658|NCT03011450|144562521|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<.0001
72515659|NCT03011450|144562522|SUPERIORITY|||||||0.1651|||||||Hodges-Lehmann method|||||||0.1651
72515660|NCT03011450|144562523|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<.0001
72515661|NCT03011450|144562524|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<.0001
72515662|NCT03011450|144562525|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<.0001
72515663|NCT03011450|144562526|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<.0001
72515664|NCT03011450|144562527|SUPERIORITY|||||||0.5107|||||||Hodges-Lehmann method|||||||0.5107
72515665|NCT03011450|144562528|SUPERIORITY||Hodges-Lehmann method|||||0.0018|||||||Hodges-Lehmann method|||||||0.0018
72515666|NCT03011450|144562529|SUPERIORITY|||||||0.0742|||||||Hodges-Lehmann method|||||||0.0742
72515667|NCT03011450|144562530|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<.0001
72515668|NCT03011450|144562531|SUPERIORITY|||||||0.2707|||||||Hodges-Lehmann method|||||||0.2707
72515669|NCT03011450|144562532|SUPERIORITY|||||||0.0009|||||||Hodges-Lehmann method|||||||0.0009
72515670|NCT03011450|144562533|SUPERIORITY|||||||0.2879|||||||Hodges-Lehmann method|||||||0.2879
72515671|NCT03011450|144562534|SUPERIORITY|||||||0.9786|||||||Hodges-Lehmann method|||||||0.9786
72515672|NCT03011450|144562535|SUPERIORITY|||||||0.0075|||||||Hodges-Lehmann method|||||||0.0075
72515673|NCT03011450|144562536|SUPERIORITY|||||||0.0241|||||||Hodges-Lehmann method|||||||0.0241
72515674|NCT03011450|144562537|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<.0001
72515675|NCT03011450|144562538|SUPERIORITY|||||||0.0502|||||||Hodges-Lehmann method|||||||0.0502
72515676|NCT03011450|144562539|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<.0001
72577123|NCT02045147|144680862|OTHER||Mean Difference (Final Values)|4.2|STANDARD_ERROR_OF_MEAN|2.7||0.146|TWO_SIDED|95.0|-1.5|9.5|||t-test, 2 sided|||||9.5|-1.5|0.146
72488380|NCT01431274|144505156|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.041|STANDARD_ERROR_OF_MEAN|0.025||0.1042|TWO_SIDED|95.0|-0.008|0.09||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (5 µg).~Spatial power covariance structure for within-patient errors."|||0.090|-0.008|0.1042
72488381|NCT01431274|144505156|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.065|STANDARD_ERROR_OF_MEAN|0.025||0.0097|TWO_SIDED|95.0|0.016|0.114||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tio+Olo FDC (2.5/5 µg).~Spatial power covariance structure for within-patient errors."|||0.114|0.016|0.0097
72488382|NCT01431274|144505156|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.112|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.063|0.161||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.161|0.063|<0.0001
72488383|NCT01431274|144505156|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.063|STANDARD_ERROR_OF_MEAN|0.025||0.012|TWO_SIDED|95.0|0.014|0.112||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within-patient errors."|||0.112|0.014|0.0120
72488384|NCT01431274|144505156|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.056|STANDARD_ERROR_OF_MEAN|0.025||0.025|TWO_SIDED|95.0|0.007|0.105||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (2.5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within-patient errors."|||0.105|0.007|0.0250
72488385|NCT01431274|144505156|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.007|STANDARD_ERROR_OF_MEAN|0.025||0.7889|TWO_SIDED|95.0|-0.042|0.056||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.056|-0.042|0.7889
72488386|NCT01431274|144505157|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.187|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.138|0.237||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within-patient errors."|||0.237|0.138|<0.0001
72488387|NCT01431274|144505157|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.121|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.072|0.17||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Tiotropium (5 μg).~Spatial power covariance structure for within-patient errors."|||0.170|0.072|<0.0001
72488388|NCT01431274|144505157|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.153|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.103|0.202||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within-patient errors."|||0.202|0.103|<0.0001
72488389|NCT01431274|144505157|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.062|STANDARD_ERROR_OF_MEAN|0.025||0.0134|TWO_SIDED|95.0|0.013|0.111||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.111|0.013|0.0134
72488390|NCT01431274|144505157|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.086|STANDARD_ERROR_OF_MEAN|0.025||0.0006|TWO_SIDED|95.0|0.037|0.136||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (5 µg).~Spatial power covariance structure for within-patient errors."|||0.136|0.037|0.0006
72403916|NCT01344447|144314044|NON_INFERIORITY_OR_EQUIVALENCE|using a -7.5% non-inferiority margin|Percentage difference|9.1|||||TWO_SIDED|95.1|7.9||Not Appropriate, upper intervals were not used in the statistical analysis and were not of interest for the study.||The cluster-adjusted two-sided 95% CI|||Clinical investigator; the percentage difference was calculated as gadobutrol-enhanced minus unenhanced MRA.|||7.9|
72488391|NCT01431274|144505157|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.035|STANDARD_ERROR_OF_MEAN|0.025||0.167|TWO_SIDED|95.0|-0.015|0.084||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tio+Olo FDC (2.5/5 µg).~Spatial power covariance structure for within-patient errors."|||0.084|-0.015|0.1670
72403917|NCT01344447|144314045|SUPERIORITY_OR_OTHER||percentage|61.7|||||ONE_SIDED|95.1|55.3||||One sided 95.1% confidence interval|||Majority reader|||55.3|
72403918|NCT01344447|144314045|SUPERIORITY_OR_OTHER||percentage|60.3|||||ONE_SIDED|95.1|53.6||||One sided 95.1% confidence interval|||Blinded Reader 1|||53.6|
72403919|NCT01344447|144314045|SUPERIORITY_OR_OTHER||percentage|59.6|||||ONE_SIDED|95.1|53.1||||One sided 95.1% confidence interval|||Blinded Reader 2|||53.1|
72403920|NCT01344447|144314045|SUPERIORITY_OR_OTHER||percentage|58.7|||||ONE_SIDED|95.1|52.2||||One sided 95.1% confidence interval|||Blinded Reader 3|||52.2|
72403921|NCT01344447|144314045|SUPERIORITY_OR_OTHER||percentage|61.5|||||ONE_SIDED|95.1|56.7||||One sided 95.1% confidence interval|||Clinical investigator|||56.7|
72403922|NCT01344447|144314046|SUPERIORITY_OR_OTHER||percentage|98.0|||||ONE_SIDED|95.1|97.7||||One sided 95.1% confidence interval|||Majority reader|||97.7|
72403923|NCT01344447|144314046|SUPERIORITY_OR_OTHER||percentage|97.6|||||ONE_SIDED|95.1|97.3||||One sided 95.1% confidence interval|||Blinded Reader 1|||97.3|
72403924|NCT01344447|144314046|SUPERIORITY_OR_OTHER||percentage|97.2|||||ONE_SIDED|95.1|96.9||||One sided 95.1% confidence interval|||Blinded Reader 2|||96.9|
72403925|NCT01344447|144314046|SUPERIORITY_OR_OTHER||percentage|98.0|||||ONE_SIDED|95.1|97.7||||One sided 95.1% confidence interval|||Blinded Reader 3|||97.7|
72403926|NCT01344447|144314046|SUPERIORITY_OR_OTHER||percentage|99.2|||||ONE_SIDED|95.1|98.9||||One sided 95.1% confidence interval|||Clinical investigator|||98.9|
72488392|NCT01431274|144505157|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.097|STANDARD_ERROR_OF_MEAN|0.025||0.0001|TWO_SIDED|95.0|0.048|0.146||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.146|0.048|0.0001
72515677|NCT03011450|144562540|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<.0001
72515678|NCT03011450|144562541|SUPERIORITY|||||||0.0209|||||||Hodges-Lehmann method|||||||0.0209
72515679|NCT03011450|144562542|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<0.0001
72515680|NCT03011450|144562543|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<0.0001
72403927|NCT01344447|144314047|SUPERIORITY_OR_OTHER||Diameter difference|0.21|STANDARD_DEVIATION|0.8|||||||||Mean Difference|||CTA Minus Unenhanced MRA for blinded Reader on vessel DIA at normal point||||
72403928|NCT01344447|144314047|SUPERIORITY_OR_OTHER||Diameter difference|0.0|STANDARD_DEVIATION|0.79|||||||||Mean Difference|||CTA minus Gadobutrol-Enhanced MRA for blinded reader on vessel DIA at normal point||||
72403929|NCT01344447|144314047|SUPERIORITY_OR_OTHER||Diameter difference|0.29|STANDARD_DEVIATION|0.87|||||||||Mean Difference|||CTA minus Unenhanced MRA for blinded reader on vessel DIA at narrowest point||||
72403930|NCT01344447|144314047|SUPERIORITY_OR_OTHER||Diameter difference|0.01|STANDARD_DEVIATION|0.8|||||||||Mean Difference|||CTA minus Gadobutrol-Enhanced MRA for blinded reader on vessel DIA at narrowest point||||
72403931|NCT01344447|144314047|SUPERIORITY_OR_OTHER||Diameter difference|0.48|STANDARD_DEVIATION|0.98|||||||||Mean Difference|||CTA minus Unenhanced MRA for clinical investigators on vessel DIA at normal point||||
72403932|NCT01344447|144314047|SUPERIORITY_OR_OTHER||Diameter difference|0.33|STANDARD_DEVIATION|1.01|||||||||Mean Difference|||CTA minus Gadobutrol-enhanced MRA for clinical investigators on vessel DIA at normal point||||
72403933|NCT01344447|144314047|SUPERIORITY_OR_OTHER||Diameter difference|0.02|STANDARD_DEVIATION|0.81|||||||||Mean Difference|||CTA minus Unenhanced MRA for clinical investigators on vessel DIA at narrowest point||||
72403934|NCT01344447|144314047|SUPERIORITY_OR_OTHER||Diameter difference|0.11|STANDARD_DEVIATION|0.79|||||||||Mean Difference|||CTA minus Gadobutrol-enhanced MRA for clinical investigators on vessel DIA at narrowest point||||
72403935|NCT01928862|144314075|OTHER||Treatment difference|-31.3|||||TWO_SIDED|90.0|-58.8|0.8||||||Confidence interval (CI) of the difference in proportions between each Prepopik® group and PEG within each age group was calculated using the Clopper-Pearson method.||0.8|-58.8|
72403936|NCT01928862|144314075|OTHER||Treatment Difference|6.3|||||TWO_SIDED|90.0|-25.3|36.9||||||CI of the difference in proportions between each Prepopik® group and PEG within each age group was calculated using the Clopper-Pearson method.||36.9|-25.3|
72403937|NCT01928862|144314075|OTHER||Treatment Difference|-4.5|||||TWO_SIDED|90.0|-33.5|26.3||||||CI of the difference in proportions between each Prepopik® group and PEG within each age group was calculated using the Clopper-Pearson method.||26.3|-33.5|
72403938|NCT04649164|144314096|SUPERIORITY|||||||0.36|||||||t-test, 2 sided|||Paired t-tests comparing peer mentors' baseline and 16-week scores, and caregiver mentees' baseline and 16-week scores, respectively||||0.36
72403939|NCT04649164|144314098|SUPERIORITY|||||||0.3|||||||t-test, 2 sided|||||||0.30
72403940|NCT04649164|144314099|SUPERIORITY|||||||0.1|||||||t-test, 2 sided|||||||0.1
72403941|NCT04649164|144314100|SUPERIORITY||Mean Difference (Final Values)|0.78||||0.04|TWO_SIDED||||||t-test, 2 sided|||||||0.04
72403942|NCT04649164|144314103|SUPERIORITY|||||||0.13|||||||t-test, 2 sided|||||||0.13
72488393|NCT01431274|144505157|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.066|STANDARD_ERROR_OF_MEAN|0.025||0.0085|TWO_SIDED|95.0|0.017|0.115||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within-patient errors."|||0.115|0.017|0.0085
72488394|NCT01431274|144505157|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.09|STANDARD_ERROR_OF_MEAN|0.025||0.0003|TWO_SIDED|95.0|0.041|0.14||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (2.5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within-patient errors."|||0.140|0.041|0.0003
72488395|NCT01431274|144505157|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.024|STANDARD_ERROR_OF_MEAN|0.025||0.3332|TWO_SIDED|95.0|-0.074|0.025||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.025|-0.074|0.3332
72488396|NCT01431274|144505158|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.153|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001|TWO_SIDED|95.0|0.105|0.201||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within-patient errors."|||0.201|0.105|<0.0001
72488397|NCT01431274|144505158|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.077|STANDARD_ERROR_OF_MEAN|0.024||0.0016|TWO_SIDED|95.0|0.029|0.125||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Tiotropium (5 μg).~Spatial power covariance structure for within-patient errors."|||0.125|0.029|0.0016
72488398|NCT01431274|144505158|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.132|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.084|0.18||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within-patient errors."|||0.180|0.084|<0.0001
72488399|NCT01431274|144505158|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.041|STANDARD_ERROR_OF_MEAN|0.024||0.0926|TWO_SIDED|95.0|-0.007|0.089||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.089|-0.007|0.0926
72488400|NCT01431274|144505158|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.055|STANDARD_ERROR_OF_MEAN|0.024||0.0231|TWO_SIDED|95.0|0.008|0.103||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (5 µg).~Spatial power covariance structure for within-patient errors."|||0.103|0.008|0.0231
72488401|NCT01431274|144505158|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.021|STANDARD_ERROR_OF_MEAN|0.024||0.3802|TWO_SIDED|95.0|-0.026|0.069||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tio+Olo FDC (2.5/5 µg).~Spatial power covariance structure for within-patient errors."|||0.069|-0.026|0.3802
72488402|NCT01431274|144505158|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.062|STANDARD_ERROR_OF_MEAN|0.024||0.0105|TWO_SIDED|95.0|0.015|0.11||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.110|0.015|0.0105
72488403|NCT01431274|144505158|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.076|STANDARD_ERROR_OF_MEAN|0.025||0.0018|TWO_SIDED|95.0|0.028|0.125||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within-patient errors."|||0.125|0.028|0.0018
72488404|NCT01431274|144505158|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.091|STANDARD_ERROR_OF_MEAN|0.025||0.0002|TWO_SIDED|95.0|0.043|0.139||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (2.5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within-patient errors."|||0.139|0.043|0.0002
72488405|NCT01431274|144505158|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.014|STANDARD_ERROR_OF_MEAN|0.024||0.5554|TWO_SIDED|95.0|-0.062|0.034||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.034|-0.062|0.5554
72515681|NCT03011450|144562544|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<0.0001
72488406|NCT01431274|144505159|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.178|STANDARD_ERROR_OF_MEAN|0.026|<|0.0001|TWO_SIDED|95.0|0.127|0.228||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within-patient errors."|||0.228|0.127|<0.0001
72515682|NCT03011450|144562545|SUPERIORITY||||||<|0.0001|||||||non-parametric Hodges-Lehmann method|||||||<0.0001
72515683|NCT03011450|144562546|SUPERIORITY|||||||0.0001|||||||Hodges-Lehmann method|||||||0.0001
72515684|NCT03011450|144562547|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<0.0001
72515685|NCT01529385|144562606|SUPERIORITY_OR_OTHER||||||>|0.05||||||0.05 set as a priori threshold for statistical significance; Sidak correction for multiple comparisons used|ANOVA|||||||>0.05
72624286|NCT00863304|144778627|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.52|STANDARD_ERROR_OF_MEAN|0.24||0.034|TWO_SIDED|95.0|-0.99|-0.04||P-value was based on pairwise comparisons.|ANCOVA|||Week 12: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.04|-0.99|0.034
72624287|NCT00863304|144778627|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.64|STANDARD_ERROR_OF_MEAN|0.24||0.009|TWO_SIDED|9.0|-1.12|-0.16||P-value was based on pairwise comparisons.|ANCOVA|||Week 12: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.16|-1.12|0.009
72624288|NCT00863304|144778627|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.56|STANDARD_ERROR_OF_MEAN|0.24||0.023|TWO_SIDED|95.0|-1.04|-0.08||P-value was based on pairwise comparisons.|ANCOVA|||Week 12: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.08|-1.04|0.023
72624289|NCT00863304|144778627|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.12|STANDARD_ERROR_OF_MEAN|0.24|<|0.001|TWO_SIDED|95.0|-1.6|-0.64||P-value was based on pairwise comparisons.|ANCOVA|||Week 16: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.64|-1.60|<0.001
72624290|NCT00863304|144778627|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.87|STANDARD_ERROR_OF_MEAN|0.25|<|0.001|TWO_SIDED|95.0|-1.35|-0.39||P-value was based on pairwise comparisons.|ANCOVA|||Week 16: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.39|-1.35|<0.001
72624291|NCT00863304|144778627|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.41|STANDARD_ERROR_OF_MEAN|0.25||0.092|TWO_SIDED|95.0|-0.9|0.07||P-value was based on pairwise comparisons.|ANCOVA|||Week 16: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||0.07|-0.90|0.092
72624292|NCT00863304|144778627|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.71|STANDARD_ERROR_OF_MEAN|0.25||0.004|TWO_SIDED|95.0|-1.19|-0.23||P-value was based on pairwise comparisons.|ANCOVA|||Week 16: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.23|-1.19|0.004
72624293|NCT00863304|144778627|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.46|STANDARD_ERROR_OF_MEAN|0.25||0.064|TWO_SIDED|95.0|-0.94|0.03||P-value was based on pairwise comparisons.|ANCOVA|||Week 16: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||0.03|-0.94|0.064
72624294|NCT00863304|144778628|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.22||0.001|TWO_SIDED|95.0|-1.12|-0.27||P-value was based on pairwise comparisons.|ANCOVA|||Week 2: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.27|-1.12|0.001
72403943|NCT02053753|144314107|NON_INFERIORITY_OR_EQUIVALENCE|The 2 treatments were considered bioequivalent if the 90% CIs for the ratio of the geometric means were between 0.80 and 1.25.|Ratio of Geometrc Means (CP4:CP2)|1.084|||||TWO_SIDED|90.0|0.995|1.181|||||The ratio and confidence interval of the geometric means are based on natural log scale data converted back to the original scale.|||1.181|0.995|
72403944|NCT02053753|144314108|NON_INFERIORITY_OR_EQUIVALENCE|The 2 treatments were considered bioequivalent if the 90% CIs for the ratio of the geometric means were between 0.80 and 1.25.|Ratio of Geometric Means (CP4:CP2)|1.028|||||TWO_SIDED|90.0|0.934|1.131|||||The ratio and confidence interval of the geometric means are based on natural log scale data converted back to the original scale.|||1.131|0.934|
72403945|NCT00499096|144314142|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Mixed Models Analysis|||||||<.05
72515686|NCT01529385|144562607|SUPERIORITY_OR_OTHER||||||<|0.05||||||0.05 set as a priori threshold for statistical significance; Sidak correction for multiple comparisons used|ANOVA|||||||<0.05
72515687|NCT01529385|144562608|SUPERIORITY_OR_OTHER||||||<|0.05||||||0.05 set as a priori threshold for statistical significance; Sidak correction for multiple comparisons used|ANOVA|||||||<.05
72515688|NCT01529385|144562609|SUPERIORITY_OR_OTHER||||||>|0.05||||||0.05 set as a priori threshold for statistical significance; Sidak correction for multiple comparisons used|ANOVA|||||||>0.05
72515689|NCT01529385|144562610|SUPERIORITY_OR_OTHER||||||>|0.05||||||0.05 set as a priori threshold for statistical significance; Sidak correction for multiple comparisons used|ANOVA|||||||>0.05
72515690|NCT01529385|144562611|SUPERIORITY_OR_OTHER||||||>|0.05||||||0.05 set as a priori threshold for statistical significance; Sidak correction for multiple comparisons used|ANOVA|||||||>0.05
72624295|NCT00863304|144778628|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.66|STANDARD_ERROR_OF_MEAN|0.22||0.003|TWO_SIDED|95.0|-1.09|-0.23||P-value was based on pairwise comparisons.|ANCOVA|||Week 2: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.23|-1.09|0.003
72624296|NCT00863304|144778628|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.82|STANDARD_ERROR_OF_MEAN|0.22|<|0.001|TWO_SIDED|95.0|-1.25|-0.39||P-value was based on pairwise comparisons.|ANCOVA|||Week 2: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.39|-1.25|<0.001
72624297|NCT00863304|144778628|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.12|STANDARD_ERROR_OF_MEAN|0.22||0.572|TWO_SIDED|95.0|-0.31|0.55||P-value was based on pairwise comparisons.|ANCOVA|||Week 2: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||0.55|-0.31|0.572
72624298|NCT00863304|144778628|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.16|STANDARD_ERROR_OF_MEAN|0.22||0.467|TWO_SIDED|95.0|-0.27|0.59||P-value was based on pairwise comparisons.|ANCOVA|||Week 2: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||0.59|-0.27|0.467
72624299|NCT00863304|144778628|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.28|STANDARD_ERROR_OF_MEAN|0.23|<|0.001|TWO_SIDED|95.0|-1.74|-0.83||P-value was based on pairwise comparisons.|ANCOVA|||Week 4: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.83|-1.74|<0.001
72515691|NCT01529385|144562613|SUPERIORITY_OR_OTHER||||||>|0.05||||||0.05 set as a priori threshold for statistical significance; Sidak correction for multiple comparisons used|ANOVA|||||||>0.05
72515692|NCT01529385|144562614|SUPERIORITY_OR_OTHER||||||>|0.05||||||0.05 set as a priori threshold for statistical significance; Sidak correction for multiple comparisons used|ANOVA|||||||>0.05
72515693|NCT01529385|144562615|SUPERIORITY_OR_OTHER||||||>|0.05||||||0.05 set as a priori threshold for statistical significance; Sidak correction for multiple comparisons used|ANOVA|||||||>0.05
72515694|NCT04009213|144562649|NON_INFERIORITY|H0: δT - δC ≥ 0.9 Ha: δT - δC \< 0.9|||||<|0.025|ONE_SIDED|95.0|||||ANCOVA|||||||< 0.025
72515695|NCT04009213|144562650|NON_INFERIORITY|H0: qT - qC ≥ 10% H1: qT - qC \< 10%|||||<|0.025|ONE_SIDED|95.0|||||Farrington-Manning|||||||< 0.025
72515696|NCT04009213|144562651|NON_INFERIORITY|H0: pC - pT ≥ 10% H1: pC - pT \< 10%,|||||<|0.025|ONE_SIDED|95.0|||||Farrington-Manning|||||||<0.025
72515697|NCT04009213|144562652|NON_INFERIORITY|H0: πC - πT ≥ 15% H1: πC - πT \< 15%,|||||<|0.025|ONE_SIDED|95.0|||||Farrington-Manning|||||||< 0.025
72515698|NCT01709981|144562661|EQUIVALENCE|Mann-Whitney||||||0.31|||||||Wilcoxon (Mann-Whitney)|2-sided||||||0.31
72515699|NCT01763866|144562671|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-71.42|STANDARD_ERROR_OF_MEAN|3.11|<|0.001|TWO_SIDED|95.0|-77.55|-65.29||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||The null hypothesis was that there was no difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.||-65.29|-77.55|<0.001
72515700|NCT01763866|144562671|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-59.16|STANDARD_ERROR_OF_MEAN|3.44|<|0.001|TWO_SIDED|95.0|-65.94|-52.38||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||The null hypothesis was that there was no difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.||-52.38|-65.94|<0.001
72515701|NCT01763866|144562671|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-39.6|STANDARD_ERROR_OF_MEAN|3.15|<|0.001|TWO_SIDED|95.0|-45.81|-33.4||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||The null hypothesis was that there was no mean difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and ezetimibe, and the alternative hypothesis was that a mean difference did exist.||-33.40|-45.81|<0.001
72515702|NCT01763866|144562671|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-41.1|STANDARD_ERROR_OF_MEAN|3.41|<|0.001|TWO_SIDED|95.0|-47.83|-34.37||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||The null hypothesis was that there was no mean difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and ezetimibe, and the alternative hypothesis was that a mean difference did exist.||-34.37|-47.83|<0.001
72515703|NCT01763866|144562671|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-76.29|STANDARD_ERROR_OF_MEAN|5.36|<|0.001|TWO_SIDED|95.0|-86.87|-65.72||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||The null hypothesis was that there was no difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.||-65.72|-86.87|<0.001
72515704|NCT01763866|144562671|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-70.51|STANDARD_ERROR_OF_MEAN|4.72|<|0.001|TWO_SIDED|95.0|-79.81|-61.2||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||The null hypothesis was that there was no difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.||-61.20|-79.81|<0.001
72515705|NCT01763866|144562671|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-47.2|STANDARD_ERROR_OF_MEAN|5.24|<|0.001|TWO_SIDED|95.0|-57.54|-36.86||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||The null hypothesis was that there was no mean difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and ezetimibe, and the alternative hypothesis was that a mean difference did exist.||-36.86|-57.54|<0.001
72515706|NCT01763866|144562671|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-38.88|STANDARD_ERROR_OF_MEAN|4.73|<|0.001|TWO_SIDED|95.0|-48.21|-29.56||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||The null hypothesis was that there was no mean difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and ezetimibe, and the alternative hypothesis was that a mean difference did exist.||-29.56|-48.21|<0.001
72515707|NCT01763866|144562671|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-68.21|STANDARD_ERROR_OF_MEAN|3.3|<|0.001|TWO_SIDED|95.0|-74.72|-61.7||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||The null hypothesis was that there was no difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.||-61.70|-74.72|<0.001
72515708|NCT01763866|144562671|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-64.49|STANDARD_ERROR_OF_MEAN|3.21|<|0.001|TWO_SIDED|95.0|-70.84|-58.14||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||The null hypothesis was that there was no difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.||-58.14|-70.84|<0.001
72515709|NCT01763866|144562671|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-68.31|STANDARD_ERROR_OF_MEAN|4.42|<|0.001|TWO_SIDED|95.0|-77.04|-59.57||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||The null hypothesis was that there was no difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.||-59.57|-77.04|<0.001
72515710|NCT01763866|144562671|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-54.98|STANDARD_ERROR_OF_MEAN|5.23|<|0.001|TWO_SIDED|95.0|-65.31|-44.65||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||The null hypothesis was that there was no difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.||-44.65|-65.31|<0.001
72515711|NCT01763866|144562671|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-70.56|STANDARD_ERROR_OF_MEAN|3.12|<|0.001|TWO_SIDED|95.0|-76.72|-64.41||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||The null hypothesis was that there was no difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.||-64.41|-76.72|<0.001
72515712|NCT01763866|144562671|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-60.41|STANDARD_ERROR_OF_MEAN|4.41|<|0.001|TWO_SIDED|95.0|-69.11|-51.72||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit||The null hypothesis was that there was no difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.||-51.72|-69.11|<0.001
72515713|NCT01763866|144562672|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-69.95|STANDARD_ERROR_OF_MEAN|2.76|<|0.001|TWO_SIDED|95.0|-75.38|-64.51||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||The null hypothesis was that there was no difference in the percent change from Baseline in the average value of LDL-C at Weeks 10 and 12 between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.||-64.51|-75.38|<0.001
72515714|NCT01763866|144562672|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-62.82|STANDARD_ERROR_OF_MEAN|3.17|<|0.001|TWO_SIDED|95.0|-69.06|-56.57||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||The null hypothesis was that there was no difference in the percent change from Baseline in the average value of LDL-C at Weeks 10 and 12 between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.||-56.57|-69.06|<0.001
72515715|NCT01763866|144562672|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-37.53|STANDARD_ERROR_OF_MEAN|2.79|<|0.001|TWO_SIDED|95.0|-43.03|-32.03||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||The null hypothesis was that there was no difference in the percent change from Baseline in the average value of LDL-C at Weeks 10 and 12 between evolocumab and ezetimibe, and the alternative hypothesis was that a mean difference did exist.||-32.03|-43.03|<0.001
72568493|NCT00270257|144668366|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.8712||||0.362|TWO_SIDED|95.0|0.6477|1.1718||P value applies for the comparison at visit 104 only. See the estimation comments for the other visits|Generalized linear model|adjusted for site.||||1.1718|0.6477|0.3620
72568494|NCT00270257|144668367|SUPERIORITY_OR_OTHER_LEGACY||Incident rate of 100 person-years|22.0|||||TWO_SIDED|95.0|14.7|31.6|||||29 events over 132 person-years|||31.6|14.7|
72568495|NCT00270257|144668367|SUPERIORITY_OR_OTHER_LEGACY||Incident rate of 100 person-years|4.59|||||TWO_SIDED|95.0|2.0|9.0|||||8 events over 174 person-years|||9.0|2.0|
72568496|NCT00270257|144668368|SUPERIORITY_OR_OTHER_LEGACY||Incident rate of 100 person-years|2.7|||||TWO_SIDED|95.0|1.22|5.08|||||9 events over 336 person-years|||5.08|1.22|
72568497|NCT00270257|144668368|SUPERIORITY_OR_OTHER_LEGACY||Incident rate of 100 person-years|0.0|||||TWO_SIDED|95.0|0.0|10.1|||||0 events over 37 person-years|||10.1|0.00|
72577124|NCT02045147|144680862|OTHER||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|4.3||0.926|TWO_SIDED|95.0|-8.5|9.3|||t-test, 2 sided|||||9.3|-8.5|0.926
72577125|NCT02045147|144680862|OTHER||Mean Difference (Final Values)|-1.5|STANDARD_ERROR_OF_MEAN|2.4||0.526|TWO_SIDED|95.0|-6.4|3.3|||t-test, 2 sided|||||3.3|-6.4|0.526
72403946|NCT01203072|144314149|SUPERIORITY_OR_OTHER||||||<|0.001||||||Significance level for Cochran-Armitage test and comparison using Shirley-Williams method was set at one-sided, 0.025. For other tests, significance level and confidence coefficient were set at two-sided, 0.05 and 0.95, respectively, unless specified|Cochran-Armitage|||As the primary analysis, the dose-response relationship in the incidence of thromboembolic event was verified using the Cochran-Armitage test.||||<0.001
72488407|NCT01431274|144505159|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.084|STANDARD_ERROR_OF_MEAN|0.026||0.0011|TWO_SIDED|95.0|0.033|0.134||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Tiotropium (5 μg).~Spatial power covariance structure for within-patient errors."|||0.134|0.033|0.0011
72488408|NCT01431274|144505159|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.142|STANDARD_ERROR_OF_MEAN|0.026|<|0.0001|TWO_SIDED|95.0|0.091|0.192||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within-patient errors."|||0.192|0.091|<0.0001
72488409|NCT01431274|144505159|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.041|STANDARD_ERROR_OF_MEAN|0.026||0.1112|TWO_SIDED|95.0|-0.009|0.091||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.091|-0.009|0.1112
72488410|NCT01431274|144505159|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.048|STANDARD_ERROR_OF_MEAN|0.026||0.0632|TWO_SIDED|95.0|-0.003|0.098||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (5 µg).~Spatial power covariance structure for within-patient errors."|||0.098|-0.003|0.0632
72488411|NCT01431274|144505159|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.036|STANDARD_ERROR_OF_MEAN|0.026||0.1615|TWO_SIDED|95.0|-0.014|0.086||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tio+Olo FDC (2.5/5 µg).~Spatial power covariance structure for within-patient errors."|||0.086|-0.014|0.1615
72488412|NCT01431274|144505159|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.077|STANDARD_ERROR_OF_MEAN|0.026||0.0027|TWO_SIDED|95.0|0.027|0.127||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.127|0.027|0.0027
72488413|NCT01431274|144505159|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.094|STANDARD_ERROR_OF_MEAN|0.026||0.0003|TWO_SIDED|95.0|0.044|0.144||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within-patient errors."|||0.144|0.044|0.0003
72488414|NCT01431274|144505159|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.101|STANDARD_ERROR_OF_MEAN|0.026|<|0.0001|TWO_SIDED|95.0|0.05|0.151||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (2.5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within-patient errors."|||0.151|0.050|<0.0001
72488415|NCT01431274|144505159|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.007|STANDARD_ERROR_OF_MEAN|0.026||0.7925|TWO_SIDED|95.0|-0.057|0.044||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.044|-0.057|0.7925
72515716|NCT01763866|144562672|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-43.49|STANDARD_ERROR_OF_MEAN|3.15|<|0.001|TWO_SIDED|95.0|-49.7|-37.28||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||The null hypothesis was that there was no difference in the percent change from Baseline in the average value of LDL-C at Weeks 10 and 12 between evolocumab and ezetimibe, and the alternative hypothesis was that a mean difference did exist.||-37.28|-49.70|<0.001
72577126|NCT02045147|144680863|OTHER||Mean Difference (Final Values)|-1.1|STANDARD_ERROR_OF_MEAN|3.9||0.776|TWO_SIDED|95.0|-9.2|6.9|||t-test, 2 sided|||||6.9|-9.2|0.776
72577127|NCT02045147|144680863|OTHER||Mean Difference (Final Values)|5.0|STANDARD_ERROR_OF_MEAN|3.3||0.135|TWO_SIDED|95.0|-1.6|11.7|||t-test, 2 sided|||||11.7|-1.6|0.135
72488416|NCT01431274|144505160|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.118|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001|TWO_SIDED|95.0|0.074|0.162||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||Tio+Olo FDC (5/5 μg) versus Olodaterol (5 μg).|||0.162|0.074|<0.0001
72488417|NCT01431274|144505160|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.123|STANDARD_ERROR_OF_MEAN|0.023|<|0.0001|TWO_SIDED|95.0|0.077|0.169||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||Tio+Olo FDC (5/5 μg) versus Tiotropium (5 μg).|||0.169|0.077|<0.0001
72577128|NCT02045147|144680863|OTHER||Mean Difference (Final Values)|-2.4|STANDARD_ERROR_OF_MEAN|4.1||0.556|TWO_SIDED|95.0|-10.9|6.0|||t-test, 2 sided|||||6.0|-10.9|0.556
72403947|NCT01067768|144314151|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.81|||||TWO_SIDED|95.0|0.5|1.3|||||The primary outcome analysis was performed using relative risk (RR) between the rate of urinary tract infection per 1,000 days of exposure of the test subjects to intervention and that of patients undergoing routine care.|The sample size was calculated for the primary outcome. An infection rate 15 per 1,000 urinary catheter days in the control group and an expected reduction in the intervention group 40% clinically important effect. Mapping one to one, 5% alpha error and beta error 20%.||1.3|0.50|
72403948|NCT01067768|144314152|SUPERIORITY_OR_OTHER|||||||0.016||95.0||||The difference between groups was evaluated with a U test Mann Whitney. The difference was statistically significant with p values less than 0.05|Wilcoxon (Mann-Whitney)|||Null hypothesis: On average catheterization are the same in patients with daily review of the indication and control group patients||||0.016
72403949|NCT02767427|144314187|EQUIVALENCE|An equivalence test on data from a parallel-group design with sample sizes of 18 in the reference group and 18 in the treatment group achieves 80% power. The significance was set at 5%. The standard deviation was 1.00, and the equivalence limits were set at -1.00 and 1.00.|||||<|0.05|||||||t-test, 1 sided|Two one-sided t-tests were conducted with 18 in each group.||||||<0.05
72488418|NCT01431274|144505160|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.071|STANDARD_ERROR_OF_MEAN|0.022||0.0012|TWO_SIDED|95.0|0.028|0.114||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||Tio+Olo FDC (2.5/5 μg) versus Olodaterol (5 μg).|||0.114|0.028|0.0012
72488419|NCT01431274|144505160|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.094|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001|TWO_SIDED|95.0|0.05|0.137||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||Tio+Olo FDC (2.5/5 μg) versus Tiotropium (2.5 µg).|||0.137|0.050|<0.0001
72488420|NCT01431274|144505160|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.076|STANDARD_ERROR_OF_MEAN|0.023||0.001|TWO_SIDED|95.0|0.031|0.121||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||Tio+Olo FDC (2.5/5 μg) versus Tiotropium (5 µg).|||0.121|0.031|0.0010
72515717|NCT01763866|144562672|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-74.92|STANDARD_ERROR_OF_MEAN|4.85|<|0.001|TWO_SIDED|95.0|-84.49|-65.35||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||The null hypothesis was that there was no difference in the percent change from Baseline in the average value of LDL-C at Weeks 10 and 12 between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.||-65.35|-84.49|<0.001
72488421|NCT01431274|144505160|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.047|STANDARD_ERROR_OF_MEAN|0.023||0.0384|TWO_SIDED|95.0|0.003|0.092||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||Tio+Olo FDC (5/5 µg) versus Tio+Olo FDC (2.5/5 µg).|||0.092|0.003|0.0384
72488422|NCT01431274|144505160|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.141|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001|TWO_SIDED|95.0|0.097|0.185||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||Tio+Olo FDC (5/5 µg) versus Tiotropium (2.5 µg).|||0.185|0.097|<0.0001
72515718|NCT01763866|144562672|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-74.81|STANDARD_ERROR_OF_MEAN|4.15|<|0.001|TWO_SIDED|95.0|-83.0|-66.62||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||The null hypothesis was that there was no difference in the percent change from Baseline in the average value of LDL-C at Weeks 10 and 12 between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.||-66.62|-83.00|<0.001
72515719|NCT01763866|144562672|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-44.95|STANDARD_ERROR_OF_MEAN|4.75|<|0.001|TWO_SIDED|95.0|-54.32|-35.57||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||The null hypothesis was that there was no difference in the percent change from Baseline in the average value of LDL-C at Weeks 10 and 12 between evolocumab and ezetimibe, and the alternative hypothesis was that a mean difference did exist.||-35.57|-54.32|<0.001
72515720|NCT01763866|144562672|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-43.81|STANDARD_ERROR_OF_MEAN|4.19|<|0.001|TWO_SIDED|95.0|-52.06|-35.55||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||The null hypothesis was that there was no difference in the percent change from Baseline in the average value of LDL-C at Weeks 10 and 12 between evolocumab and ezetimibe, and the alternative hypothesis was that a mean difference did exist.||-35.55|-52.06|<0.001
72515721|NCT01763866|144562672|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-66.88|STANDARD_ERROR_OF_MEAN|2.93|<|0.001|TWO_SIDED|95.0|-72.67|-61.08||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||The null hypothesis was that there was no difference in the percent change from Baseline in the average value of LDL-C at Weeks 10 and 12 between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.||-61.08|-72.67|<0.001
72577129|NCT02045147|144680863|OTHER||Mean Difference (Final Values)|2.5|STANDARD_ERROR_OF_MEAN|2.7||0.361|TWO_SIDED|95.0|-2.9|7.9|||t-test, 2 sided|||||7.9|-2.9|0.361
72577130|NCT02045147|144680864|OTHER||Mean Difference (Final Values)|2.6|STANDARD_ERROR_OF_MEAN|4.4||0.564|TWO_SIDED|95.0|-6.4|11.6|||t-test, 2 sided|||||11.6|-6.4|0.564
72577131|NCT02045147|144680864|OTHER||Mean Difference (Final Values)|3.1|STANDARD_ERROR_OF_MEAN|3.1||0.307|TWO_SIDED|95.0|-3.0|9.3|||t-test, 2 sided|||||9.3|-3.0|0.307
72403950|NCT01073865|144314212|NON_INFERIORITY_OR_EQUIVALENCE|The lower limit of the CI of the difference is greater than or equal to -17.5%. This non-inferiority margin was pre-defined in the study protocol.|Risk Difference (RD)|1.29|||||TWO_SIDED|95.0|-11.4|13.9|||||%PFS at 24 weeks for Zoladex 10.8mg - %PFS at 24 weeks for Zoladex 3.6mg|CI for the difference (10.8 mg-3.6 mg) in %PFS at 24 weeks calculated using the score method recommended by Newcombe et al||13.90|-11.40|
72403951|NCT01073865|144314213|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-3.02|||||TWO_SIDED|95.0|-15.47|9.67|||||ORR at 24 weeks for Zoladex 10.8mg - ORR at 24 weeks for Zoladex 3.6mg|CI for the difference (10.8 mg-3.6 mg) in ORR at 24 weeks calculated using the score method recommended by Newcombe et al||9.67|-15.47|
72403952|NCT03969992|144314278|SUPERIORITY|||||||0.1924||||||A closed test procedure is used to protect the type I error rate; the order of testing was: AeroFact high dose compared to control and if significant (p-value \<0.05), the AeroFact low dose was compared to the control.|Generalized estimating equation method|||||||0.1924
72403953|NCT02907359|144314324|SUPERIORITY||Hazard Ratio (HR)|0.94||||0.6063|TWO_SIDED|95.0|0.74|1.19||OS between Guadecitabine vs Treatment Choice using stratified log-rank test. Due to pre-specified hierarchical testing plan, other endpoints were not evaluated for statistical significance.|Stratified Log-rank test|||||1.19|0.74|0.6063
72488423|NCT01431274|144505160|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.004|STANDARD_ERROR_OF_MEAN|0.023||0.8428|TWO_SIDED|95.0|-0.049|0.04||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||Tiotropium (5 µg) versus Olodaterol (5 µg).|||0.040|-0.049|0.8428
72488424|NCT01431274|144505160|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.022|STANDARD_ERROR_OF_MEAN|0.022||0.3048|TWO_SIDED|95.0|-0.065|0.02||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||Tiotropium (2.5 µg) versus Olodaterol (5 µg).|||0.020|-0.065|0.3048
72488425|NCT01431274|144505160|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.018|STANDARD_ERROR_OF_MEAN|0.023||0.4311|TWO_SIDED|95.0|-0.027|0.063||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||Tiotropium (5 µg) versus Tiotropium (2.5 µg).|||0.063|-0.027|0.4311
72488426|NCT01431274|144505161|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.098|STANDARD_ERROR_OF_MEAN|0.021|<|0.0001|TWO_SIDED|95.0|0.057|0.139||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||Tio+Olo FDC (5/5 μg) versus Olodaterol (5 μg).|||0.139|0.057|<0.0001
72488427|NCT01431274|144505161|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.106|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001|TWO_SIDED|95.0|0.063|0.149||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||Tio+Olo FDC (5/5 μg) versus Tiotropium (5 μg).|||0.149|0.063|<0.0001
72488428|NCT01431274|144505161|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.051|STANDARD_ERROR_OF_MEAN|0.021||0.0136|TWO_SIDED|95.0|0.01|0.091||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||Tio+Olo FDC (2.5/5 μg) versus Olodaterol (5 μg).|||0.091|0.010|0.0136
72488429|NCT01431274|144505161|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.075|STANDARD_ERROR_OF_MEAN|0.021||0.0003|TWO_SIDED|95.0|0.035|0.116||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||Tio+Olo FDC (2.5/5 μg) versus Tiotropium (2.5 µg).|||0.116|0.035|0.0003
72488430|NCT01431274|144505161|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.059|STANDARD_ERROR_OF_MEAN|0.022||0.0065|TWO_SIDED|95.0|0.016|0.101||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||Tio+Olo FDC (2.5/5 μg) versus Tiotropium (5 µg).|||0.101|0.016|0.0065
72515722|NCT01763866|144562672|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-66.58|STANDARD_ERROR_OF_MEAN|3.05|<|0.001|TWO_SIDED|95.0|-72.6|-60.56||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||The null hypothesis was that there was no difference in the percent change from Baseline in the average value of LDL-C at Weeks 10 and 12 between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.||-60.56|-72.60|<0.001
72515723|NCT01763866|144562672|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-65.66|STANDARD_ERROR_OF_MEAN|3.81|<|0.001|TWO_SIDED|95.0|-73.19|-58.12||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||The null hypothesis was that there was no difference in the percent change from Baseline in the average value of LDL-C at Weeks 10 and 12 between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.||-58.12|-73.19|<0.001
72488431|NCT01431274|144505161|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.047|STANDARD_ERROR_OF_MEAN|0.021||0.0277|TWO_SIDED|95.0|0.005|0.089||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||Tio+Olo FDC (5/5 µg) versus Tio+Olo FDC (2.5/5 µg).|||0.089|0.005|0.0277
72515724|NCT01763866|144562672|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-62.91|STANDARD_ERROR_OF_MEAN|4.27|<|0.001|TWO_SIDED|95.0|-71.37|-54.46||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||The null hypothesis was that there was no difference in the percent change from Baseline in the average value of LDL-C at Weeks 10 and 12 between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.||-54.46|-71.37|<0.001
72403954|NCT01405963|144314338|OTHER||Treatment Difference|7.65||||0.09|TWO_SIDED|95.0|-1.3|16.6|||ANCOVA|Model includes treatment, visit, treatment by visit interaction as fixed effects and Day -14 value as covariate.|Treatment difference estimate (tezepelumab minus placebo) is mean estimate based on ANCOVA.|Treatment difference in late asthmatic response at day 42 was evaluated using a repeated-measures analysis of covariance (ANCOVA) that included study treatment and study visit as independent variables, treatment by study visit as an interaction term, and the corresponding baseline value (as measured 14 days before the first dose of a study drug) as a model covariate.||16.60|-1.30|0.09
72403955|NCT01405963|144314338|OTHER||Treatment Difference|9.91||||0.02|TWO_SIDED|95.0|1.59|18.23|||ANCOVA|Model includes treatment, visit, treatment by visit interaction as fixed effects and Day -14 value as covariate.|Treatment difference estimate (tezepelumab minus placebo) is mean estimate based on ANCOVA.|Treatment difference in late asthmatic response at day 84 was evaluated using a repeated-measures ANCOVA that included study treatment and study visit as independent variables, treatment by study visit as an interaction term, and the corresponding baseline value (as measured 14 days before the first dose of a study drug) as a model covariate.||18.23|1.59|0.02
72488432|NCT01431274|144505161|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.122|STANDARD_ERROR_OF_MEAN|0.021|<|0.0001|TWO_SIDED|95.0|0.081|0.164||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||Tio+Olo FDC (5/5 µg) versus Tiotropium (2.5 µg).|||0.164|0.081|<0.0001
72488433|NCT01431274|144505161|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.008|STANDARD_ERROR_OF_MEAN|0.021||0.7116|TWO_SIDED|95.0|-0.049|0.034||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||Tiotropium (5 µg) versus Olodaterol (5 µg).|||0.034|-0.049|0.7116
72488434|NCT01431274|144505161|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.024|STANDARD_ERROR_OF_MEAN|0.02||0.2332|TWO_SIDED|95.0|-0.065|0.016||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||Tiotropium (2.5 µg) versus Olodaterol (5 µg).|||0.016|-0.065|0.2332
72488435|NCT01431274|144505161|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.017|STANDARD_ERROR_OF_MEAN|0.021||0.4374|TWO_SIDED|95.0|-0.025|0.059||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||Tiotropium (5 µg) versus Tiotropium (2.5 µg).|||0.059|-0.025|0.4374
72488436|NCT01431274|144505162|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.161|STANDARD_ERROR_OF_MEAN|0.043||0.0002|TWO_SIDED|95.0|0.077|0.244||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||Tio+Olo FDC (5/5 μg) versus Olodaterol (5 μg).|||0.244|0.077|0.0002
72488437|NCT01431274|144505162|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.14|STANDARD_ERROR_OF_MEAN|0.045||0.0017|TWO_SIDED|95.0|0.053|0.228||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||Tio+Olo FDC (5/5 μg) versus Tiotropium (5 μg).|||0.228|0.053|0.0017
72488438|NCT01431274|144505162|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.128|STANDARD_ERROR_OF_MEAN|0.042||0.0022|TWO_SIDED|95.0|0.046|0.21||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||Tio+Olo FDC (2.5/5 μg) versus Olodaterol (5 μg).|||0.210|0.046|0.0022
72515725|NCT01763866|144562672|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-69.43|STANDARD_ERROR_OF_MEAN|2.74|<|0.001|TWO_SIDED|95.0|-74.86|-64.01||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||The null hypothesis was that there was no difference in the percent change from Baseline in the average value of LDL-C at Weeks 10 and 12 between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.||-64.01|-74.86|<0.001
72515726|NCT01763866|144562672|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-68.45|STANDARD_ERROR_OF_MEAN|4.17|<|0.001|TWO_SIDED|95.0|-76.68|-60.22||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit||The null hypothesis was that there was no difference in the percent change from Baseline in the average value of LDL-C at Weeks 10 and 12 between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.||-60.22|-76.68|<0.001
72515727|NCT01763866|144562673|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-83.6|STANDARD_ERROR_OF_MEAN|4.5|<|0.001|TWO_SIDED|95.0|-92.6|-74.6||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-74.6|-92.6|<0.001
72515728|NCT01763866|144562673|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-79.7|STANDARD_ERROR_OF_MEAN|5.3|<|0.001|TWO_SIDED|95.0|-90.2|-69.2||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-69.2|-90.2|<0.001
72515729|NCT01763866|144562673|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-44.4|STANDARD_ERROR_OF_MEAN|4.4|<|0.001|TWO_SIDED|95.0|-53.4|-35.3||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-35.3|-53.4|<0.001
72515730|NCT01763866|144562673|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-55.0|STANDARD_ERROR_OF_MEAN|5.3|<|0.001|TWO_SIDED|95.0|-65.4|-44.6||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-44.6|-65.4|<0.001
72488439|NCT01431274|144505162|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.176|STANDARD_ERROR_OF_MEAN|0.042|<|0.0001|TWO_SIDED|95.0|0.093|0.259||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||Tio+Olo FDC (2.5/5 μg) versus Tiotropium (2.5 µg).|||0.259|0.093|<0.0001
72488440|NCT01431274|144505162|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.108|STANDARD_ERROR_OF_MEAN|0.044||0.0141|TWO_SIDED|95.0|0.022|0.194||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||Tio+Olo FDC (2.5/5 μg) versus Tiotropium (5 µg).|||0.194|0.022|0.0141
72488441|NCT01431274|144505162|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.032|STANDARD_ERROR_OF_MEAN|0.043||0.4581|TWO_SIDED|95.0|-0.053|0.118||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||Tio+Olo FDC (5/5 µg) versus Tio+Olo FDC (2.5/5 µg).|||0.118|-0.053|0.4581
72488442|NCT01431274|144505162|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.208|STANDARD_ERROR_OF_MEAN|0.043|<|0.0001|TWO_SIDED|95.0|0.124|0.293||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||Tio+Olo FDC (5/5 µg) versus Tiotropium (2.5 µg).|||0.293|0.124|<0.0001
72488443|NCT01431274|144505162|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.021|STANDARD_ERROR_OF_MEAN|0.043||0.6335|TWO_SIDED|95.0|-0.064|0.105||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||Tiotropium (5 µg) versus Olodaterol (5 µg).|||0.105|-0.064|0.6335
72488444|NCT01431274|144505162|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.047|STANDARD_ERROR_OF_MEAN|0.041||0.253|TWO_SIDED|95.0|-0.129|0.034||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||Tiotropium (2.5 µg) versus Olodaterol (5 µg).|||0.034|-0.129|0.2530
72488445|NCT01431274|144505162|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.068|STANDARD_ERROR_OF_MEAN|0.043||0.1188|TWO_SIDED|95.0|-0.017|0.153||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||Tiotropium (5 µg) versus Tiotropium (2.5 µg).|||0.153|-0.017|0.1188
72403956|NCT01405963|144314339|OTHER||Treatment Difference|-4.35||||0.11|TWO_SIDED|95.0|-9.8|1.1|||ANCOVA|Model includes treatment, visit, treatment by visit interaction as fixed effects and day -14 value as covariate.|Treatment difference estimate (tezepelumab minus placebo) is mean estimate based on ANCOVA.|Treatment difference in late asthmatic response at day 42 was evaluated using a repeated-measures analysis of covariance (ANCOVA) that included study treatment and study visit as independent variables, treatment by study visit as an interaction term, and the corresponding baseline value (as measured 14 days before the first dose of a study drug) as a model covariate.||1.10|-9.80|0.11
72403957|NCT01405963|144314339|OTHER||Treatment Difference|-4.66||||0.07|TWO_SIDED|95.0|-9.71|0.39|||ANCOVA|Model includes treatment, visit, treatment by visit interaction as fixed effects and day -14 value as covariate.|Treatment difference estimate (tezepelumab minus placebo) is mean estimate based on ANCOVA.|Treatment difference in late asthmatic response at day 84 was evaluated using a repeated-measures ANCOVA that included study treatment and study visit as independent variables, treatment by study visit as an interaction term, and the corresponding baseline value (as measured 14 days before the first dose of a study drug) as a model covariate.||0.39|-9.71|0.07
72488446|NCT01431274|144505163|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.137|STANDARD_ERROR_OF_MEAN|0.041||0.0008|TWO_SIDED|95.0|0.057|0.217||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||Tio+Olo FDC (5/5 μg) versus Olodaterol (5 μg).|||0.217|0.057|0.0008
72488447|NCT01431274|144505163|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.126|STANDARD_ERROR_OF_MEAN|0.043||0.0032|TWO_SIDED|95.0|0.042|0.209||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||Tio+Olo FDC (5/5 μg) versus Tiotropium (5 μg).|||0.209|0.042|0.0032
72488448|NCT01431274|144505163|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.105|STANDARD_ERROR_OF_MEAN|0.04||0.0085|TWO_SIDED|95.0|0.027|0.183||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||Tio+Olo FDC (2.5/5 μg) versus Olodaterol (5 μg).|||0.183|0.027|0.0085
72488449|NCT01431274|144505163|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.156|STANDARD_ERROR_OF_MEAN|0.04||0.0001|TWO_SIDED|95.0|0.077|0.235||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||Tio+Olo FDC (2.5/5 μg) versus Tiotropium (2.5 µg).|||0.235|0.077|0.0001
72488450|NCT01431274|144505163|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.094|STANDARD_ERROR_OF_MEAN|0.042||0.0255|TWO_SIDED|95.0|0.011|0.176||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||Tio+Olo FDC (2.5/5 μg) versus Tiotropium (5 µg).|||0.176|0.011|0.0255
72488451|NCT01431274|144505163|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.032|STANDARD_ERROR_OF_MEAN|0.041||0.4393|TWO_SIDED|95.0|-0.049|0.113||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||Tio+Olo FDC (5/5 µg) versus Tio+Olo FDC (2.5/5 µg).|||0.113|-0.049|0.4393
72515731|NCT01763866|144562673|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-69.9|STANDARD_ERROR_OF_MEAN|6.1|<|0.001|TWO_SIDED|95.0|-81.9|-57.8||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-57.8|-81.9|<0.001
72515732|NCT01763866|144562673|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-65.6|STANDARD_ERROR_OF_MEAN|4.5|<|0.001|TWO_SIDED|95.0|-74.5|-56.7||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-56.7|-74.5|<0.001
72515733|NCT01763866|144562673|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-45.8|STANDARD_ERROR_OF_MEAN|6.0|<|0.001|TWO_SIDED|95.0|-57.7|-33.9||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-33.9|-57.7|<0.001
72488452|NCT01431274|144505163|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.188|STANDARD_ERROR_OF_MEAN|0.041|<|0.0001|TWO_SIDED|95.0|0.108|0.269||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||Tio+Olo FDC (5/5 µg) versus Tiotropium (2.5 µg).|||0.269|0.108|<0.0001
72488453|NCT01431274|144505163|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.012|STANDARD_ERROR_OF_MEAN|0.041||0.7784|TWO_SIDED|95.0|-0.069|0.092||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||Tiotropium (5 µg) versus Olodaterol (5 µg).|||0.092|-0.069|0.7784
72488454|NCT01431274|144505163|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.051|STANDARD_ERROR_OF_MEAN|0.039||0.1965|TWO_SIDED|95.0|-0.129|0.026||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||Tiotropium (2.5 µg) versus Olodaterol (5 µg).|||0.026|-0.129|0.1965
72488455|NCT01431274|144505163|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.063|STANDARD_ERROR_OF_MEAN|0.041||0.1315|TWO_SIDED|95.0|-0.019|0.144||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||Tiotropium (5 µg) versus Tiotropium (2.5 µg).|||0.144|-0.019|0.1315
72488456|NCT01431274|144505164|SUPERIORITY_OR_OTHER||Adjusted mean difference|-2.141|STANDARD_ERROR_OF_MEAN|0.56||0.0001|TWO_SIDED|95.0|-3.239|-1.043||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within-patient errors."|||-1.043|-3.239|0.0001
72577132|NCT02045147|144680864|OTHER||Mean Difference (Final Values)|1.1|STANDARD_ERROR_OF_MEAN|3.8||0.768|TWO_SIDED|95.0|-6.7|8.9|||t-test, 2 sided|||||8.9|-6.7|0.768
72577133|NCT02045147|144680864|OTHER||Mean Difference (Final Values)|0.7|STANDARD_ERROR_OF_MEAN|2.4||0.785|TWO_SIDED|95.0|-4.2|5.5|||t-test, 2 sided|||||5.5|-4.2|0.785
72577134|NCT02045147|144680865|OTHER||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|3.5||0.917|TWO_SIDED|95.0|-7.5|6.8|||t-test, 2 sided|||||6.8|-7.5|0.917
72577135|NCT02045147|144680865|OTHER||Mean Difference (Final Values)|4.6|STANDARD_ERROR_OF_MEAN|3.3||0.181|TWO_SIDED|95.0|-2.2|11.3|||t-test, 2 sided|||||11.3|-2.2|0.181
72568498|NCT00557076|144668406|NON_INFERIORITY_OR_EQUIVALENCE|Because 50% of the planned sample size was randomized, achieved power for the DOCS is 0.51.|Mean Difference (Final Values)|5.4|STANDARD_ERROR_OF_MEAN|7.0||0.465|TWO_SIDED|95.0|-11.1|21.9|||t-test, 1 sided|DOCS scores were transformed to interval level measures using a many-faceted Rasch model anchored to values from a larger validation data set|The mean difference between the baseline and endpoint DOCS test was compared between the FAST and Sham groups.|The planned sample of 15 per group provided 80% power for a one-sided t-test to detect be-tween group endpoint differences in DOCS averages equivalent to an effect size of .91 (9 units). Clinically, this assumes that the FAST protocol would facilitate progression from one clinical state to another (e.g., vegetative (VS) to minimally conscious (MCS) states). The hypothesized effect was based on average DOCS change for a severe TBI sample receiving three weeks of acute rehabilitation.||21.9|-11.1|.465
72568499|NCT00557076|144668407|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.76|STANDARD_ERROR_OF_MEAN|0.346||0.049|TWO_SIDED|95.0|-1.51|-0.00493|||t-test, 1 sided|CNC scores were transformed to interval level measures using Rasch partial credit and Facets models. We then re-scaled these logits to 0-100 scales.|The mean difference was calculated for each group using the eighth CNC measure minus the Baseline CNC measure.|Power was not calculated for the CNC because the effect size was not published.||-.00493|-1.51|0.049
72568500|NCT00557076|144668407|SUPERIORITY_OR_OTHER||Slope|-0.63|STANDARD_ERROR_OF_MEAN|0.2||0.0022|TWO_SIDED|||||To confirm that CNC results were not an anomaly at the final measurement and that the overall CNC response pattern was consistent, mixed-effect longitudinal models were conducted.|t-test, 1 sided||The Baseline CNC measure and seven post-Baseline CNC measures (for a total of eight CNC measures) were used to calculate the slope.|||||.0022
72624300|NCT00863304|144778628|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.12|STANDARD_ERROR_OF_MEAN|0.23|<|0.001|TWO_SIDED|95.0|-1.58|-0.66||P-value was based on pairwise comparisons.|ANCOVA|||Week 4: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.66|-1.58|<0.001
72624301|NCT00863304|144778628|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.73|STANDARD_ERROR_OF_MEAN|0.23||0.002|TWO_SIDED|95.0|-1.19|-0.27||P-value was based on pairwise comparisons.|ANCOVA|||Week 4: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.27|-1.19|0.002
72624302|NCT00863304|144778628|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.55|STANDARD_ERROR_OF_MEAN|0.23||0.019|TWO_SIDED|95.0|-1.01|-0.09||P-value was based on pairwise comparisons.|ANCOVA|||Week 4: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.09|-1.01|0.019
72624303|NCT00863304|144778628|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.39|STANDARD_ERROR_OF_MEAN|0.24||0.101|TWO_SIDED|95.0|-0.85|0.08||P-value was based on pairwise comparisons.|ANCOVA|||Week 4: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||0.08|-0.85|0.101
72624304|NCT00863304|144778628|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.24|STANDARD_ERROR_OF_MEAN|0.23|<|0.001|TWO_SIDED|95.0|-1.7|-0.78||P-value was based on pairwise comparisons.|ANCOVA|||Week 8: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.78|-1.70|<0.001
72624305|NCT00863304|144778628|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.23|<|0.001|TWO_SIDED|95.0|-1.47|-0.54||P-value was based on pairwise comparisons.|ANCOVA|||Week 8: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.54|-1.47|<0.001
72624306|NCT00863304|144778628|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.62|STANDARD_ERROR_OF_MEAN|0.24||0.009|TWO_SIDED|95.0|-1.08|-0.16||P-value was based on pairwise comparisons.|ANCOVA|||Week 8: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.16|-1.08|0.009
72624307|NCT00863304|144778628|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.62|STANDARD_ERROR_OF_MEAN|0.24||0.008|TWO_SIDED|95.0|-1.08|-0.16||P-value was based on pairwise comparisons.|ANCOVA|||Week 8: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.16|-1.08|0.008
72624308|NCT00863304|144778628|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.39|STANDARD_ERROR_OF_MEAN|0.24||0.101|TWO_SIDED|95.0|-0.85|0.08||P-value was based on pairwise comparisons.|ANCOVA|||Week 8: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||0.08|-0.85|0.101
72568501|NCT00688376|144668408|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.8||||0.694|TWO_SIDED|95.0|-3.22|4.8|||ANCOVA|||P-values, least squares (LS) mean, and 95% confidence interval (CI) were obtained from Analysis of Covariance (ANCOVA) model with treatment group as a factor and Baseline value as covariate.||4.8|-3.22|0.694
72624309|NCT00863304|144778628|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.31|STANDARD_ERROR_OF_MEAN|0.24|<|0.001|TWO_SIDED|95.0|-1.79|-0.83||P-value was based on pairwise comparisons.|ANCOVA|||Week 12: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.83|-1.79|<0.001
72624310|NCT00863304|144778628|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.15|STANDARD_ERROR_OF_MEAN|0.25|<|0.001|TWO_SIDED|95.0|-1.63|-0.67||P-value was based on pairwise comparisons.|ANCOVA|||Week 12: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.67|-1.63|<0.001
72624311|NCT00863304|144778628|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.72|STANDARD_ERROR_OF_MEAN|0.25||0.003|TWO_SIDED|95.0|-1.21|-0.24||P-value was based on pairwise comparisons.|ANCOVA|||Week 12: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.24|-1.21|0.003
72624312|NCT00863304|144778628|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.59|STANDARD_ERROR_OF_MEAN|0.25||0.016|TWO_SIDED|95.0|-1.08|-0.11||P-value was based on pairwise comparisons.|ANCOVA|||Week 12: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.11|-1.08|0.016
72515734|NCT01763866|144562673|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-38.8|STANDARD_ERROR_OF_MEAN|4.5|<|0.001|TWO_SIDED|95.0|-47.8|-29.9||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-29.9|-47.8|<0.001
72515735|NCT01763866|144562673|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-75.4|STANDARD_ERROR_OF_MEAN|4.3|<|0.001|TWO_SIDED|95.0|-83.9|-67.0||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-67.0|-83.9|<0.001
72515736|NCT01763866|144562673|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-77.9|STANDARD_ERROR_OF_MEAN|5.1|<|0.001|TWO_SIDED|95.0|-88.0|-67.8||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-67.8|-88.0|<0.001
72515737|NCT01763866|144562673|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-55.8|STANDARD_ERROR_OF_MEAN|3.7|<|0.001|TWO_SIDED|95.0|-63.1|-48.4||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-48.4|-63.1|<0.001
72515738|NCT01763866|144562673|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-50.6|STANDARD_ERROR_OF_MEAN|5.1|<|0.001|TWO_SIDED|95.0|-60.6|-40.6||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-40.6|-60.6|<0.001
72515739|NCT01763866|144562673|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-78.1|STANDARD_ERROR_OF_MEAN|4.1|<|0.001|TWO_SIDED|95.0|-86.2|-70.0||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-70.0|-86.2|<0.001
72515740|NCT01763866|144562673|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-80.1|STANDARD_ERROR_OF_MEAN|5.8|<|0.001|TWO_SIDED|95.0|-91.7|-68.6||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit||||-68.6|-91.7|<0.001
72515741|NCT01763866|144562674|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-85.5|STANDARD_ERROR_OF_MEAN|4.9|<|0.001|TWO_SIDED|95.0|-95.2|-75.9||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-75.9|-95.2|<0.001
72515742|NCT01763866|144562674|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-75.8|STANDARD_ERROR_OF_MEAN|5.5|<|0.001|TWO_SIDED|95.0|-86.8|-64.9||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-64.9|-86.8|<0.001
72515743|NCT01763866|144562674|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-46.8|STANDARD_ERROR_OF_MEAN|4.9|<|0.001|TWO_SIDED|95.0|-56.6|-37.1||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-37.1|-56.6|<0.001
72515744|NCT01763866|144562674|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-51.7|STANDARD_ERROR_OF_MEAN|5.5|<|0.001|TWO_SIDED|95.0|-62.6|-40.9||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-40.9|-62.6|<0.001
72515745|NCT01763866|144562674|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-71.7|STANDARD_ERROR_OF_MEAN|6.4|<|0.001|TWO_SIDED|95.0|-84.4|-59.0||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-59.0|-84.4|<0.001
72577136|NCT02045147|144680865|OTHER||Mean Difference (Final Values)|1.1|STANDARD_ERROR_OF_MEAN|3.6||0.772|TWO_SIDED|95.0|-6.3|8.3|||t-test, 2 sided|||||8.3|-6.3|0.772
72577137|NCT02045147|144680865|OTHER||Mean Difference (Final Values)|1.8|STANDARD_ERROR_OF_MEAN|2.8||0.526|TWO_SIDED|95.0|-3.8|7.3|||t-test, 2 sided|||||7.3|-3.8|0.526
72577138|NCT02045147|144680866|OTHER||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.42||0.872|TWO_SIDED|95.0|-0.8|0.9|||t-test, 2 sided|||||.9|-.8|0.872
72577139|NCT02045147|144680866|OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.3||0.387|TWO_SIDED|95.0|-0.87|0.34|||t-test, 2 sided|||||.34|-.87|0.387
72577140|NCT02045147|144680866|OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.38||0.916|TWO_SIDED|95.0|-0.37|0.81|||t-test, 2 sided|||||.81|-.37|0.916
72577141|NCT02045147|144680866|OTHER||Mean Difference (Final Values)|0.4|STANDARD_ERROR_OF_MEAN|0.28||0.189|TWO_SIDED|95.0|-0.19|0.94|||t-test, 2 sided|||||.94|-.19|0.189
72577142|NCT02045147|144680867|OTHER||Mean Difference (Final Values)|-0.04|STANDARD_ERROR_OF_MEAN|0.08||0.627|TWO_SIDED|95.0|-0.21|0.13|||t-test, 2 sided|||||.13|-.21|0.627
72577143|NCT02045147|144680867|OTHER||Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.05||0.84|TWO_SIDED|95.0|-0.11|0.09|||t-test, 2 sided|||||.09|-.11|0.840
72577144|NCT02045147|144680867|OTHER||Mean Difference (Final Values)|-0.11|STANDARD_ERROR_OF_MEAN|0.05||0.049|TWO_SIDED|95.0|-0.22|0.0|||t-test, 2 sided|||||-.00|-.22|0.049
72577145|NCT02045147|144680867|OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.03||0.952|TWO_SIDED|95.0|-0.06|0.06|||t-test, 2 sided|||||.06|-.06|0.952
72577146|NCT02045147|144680868|OTHER||Mean Difference (Final Values)|6.9||||0.436|TWO_SIDED|95.0|-11.07|25.0|||t-test, 2 sided|||||25.00|-11.07|.436
72403958|NCT01405963|144314343|OTHER||Treatment Difference|8.57||||0.05|TWO_SIDED|95.0|0.01|17.13|||ANCOVA|Model includes treatment, visit, treatment by visit interaction as fixed effects and Day -14 value as covariate.|Treatment difference estimate (tezepelumab minus placebo) is mean estimate based on ANCOVA.|Treatment difference in early asthmatic response at day 42 was evaluated using a repeated-measures ANCOVA that included study treatment and study visit as independent variables, treatment by study visit as an interaction term, and the corresponding baseline value (as measured 14 days before the first dose of a study drug) as a model covariate.||17.13|0.01|0.05
72488457|NCT01431274|144505164|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.131|STANDARD_ERROR_OF_MEAN|0.56||0.0435|TWO_SIDED|95.0|-2.23|-0.033||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Tio+Olo FDC (5/5 μg) versus Tiotropium (5 μg).|||-0.033|-2.230|0.0435
72568502|NCT00688376|144668409|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.1||||0.9458|TWO_SIDED|95.0|-4.38|4.09|||ANCOVA|||P-values, LS mean, and 95% confidence intervals were obtained from ANCOVA model with treatment group as a factor and baseline value as covariate.||4.09|-4.38|0.9458
72488458|NCT01431274|144505164|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.528|STANDARD_ERROR_OF_MEAN|0.559||0.0063|TWO_SIDED|95.0|-2.623|-0.432||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within-patient errors."|||-0.432|-2.623|0.0063
72488459|NCT01431274|144505164|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.517|STANDARD_ERROR_OF_MEAN|0.558||0.3545|TWO_SIDED|95.0|-1.611|0.577||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.577|-1.611|0.3545
72488460|NCT01431274|144505164|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.518|STANDARD_ERROR_OF_MEAN|0.559||0.3542|TWO_SIDED|95.0|-1.614|0.578||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (5 µg).~Spatial power covariance structure for within-patient errors."|||0.578|-1.614|0.3542
72488461|NCT01431274|144505164|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.613|STANDARD_ERROR_OF_MEAN|0.556||0.2697|TWO_SIDED|95.0|-1.702|0.476||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tio+Olo FDC (2.5/5 µg).~Spatial power covariance structure for within-patient errors."|||0.476|-1.702|0.2697
72488462|NCT01431274|144505164|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.13|STANDARD_ERROR_OF_MEAN|0.559||0.0434|TWO_SIDED|95.0|-2.227|-0.033||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||-0.033|-2.227|0.0434
72488463|NCT01431274|144505164|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.01|STANDARD_ERROR_OF_MEAN|0.563||0.0732|TWO_SIDED|95.0|-2.114|0.095||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within-patient errors."|||0.095|-2.114|0.0732
72488464|NCT01431274|144505164|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.011|STANDARD_ERROR_OF_MEAN|0.563||0.0724|TWO_SIDED|95.0|-2.114|0.092||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (2.5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within-patient errors."|||0.092|-2.114|0.0724
72488465|NCT01431274|144505164|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.001|STANDARD_ERROR_OF_MEAN|0.563||0.9983|TWO_SIDED|95.0|-1.102|1.104||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||1.104|-1.102|0.9983
72568503|NCT00688376|144668410|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.4||||0.743|TWO_SIDED|95.0|-9.56|6.85|||ANCOVA|||RTVSS Change from Baseline to Week 6 (LOCF). P-values, LS mean, and 95% confidence intervals were obtained from ANCOVA model with treatment group as a factor and baseline value as covariate.||6.85|-9.56|0.743
72568504|NCT00688376|144668410|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.2||||0.9561|TWO_SIDED|95.0|-7.42|7.84|||ANCOVA|||RTVSS Change from Baseline to Week 12 (LOCF). P-values, LS mean, and 95% confidence intervals were obtained from ANCOVA model with treatment group as a factor and baseline value as covariate.||7.84|-7.42|0.9561
72577147|NCT02045147|144680868|OTHER||Mean Difference (Final Values)|-11.8|STANDARD_ERROR_OF_MEAN|6.71||0.088|TWO_SIDED|95.0|-25.24|1.8|||t-test, 2 sided|||||1.80|-25.24|.088
72488466|NCT01431274|144505165|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.852|STANDARD_ERROR_OF_MEAN|0.578||0.0014|TWO_SIDED|95.0|-2.985|-0.718||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within-patient errors."|||-0.718|-2.985|0.0014
72488467|NCT01431274|144505165|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.444|STANDARD_ERROR_OF_MEAN|0.576||0.4413|TWO_SIDED|95.0|-1.573|0.686||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Tiotropium (5 μg).~Spatial power covariance structure for within-patient errors."|||0.686|-1.573|0.4413
72488468|NCT01431274|144505165|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.437|STANDARD_ERROR_OF_MEAN|0.578||0.0129|TWO_SIDED|95.0|-2.569|-0.304||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within-patient errors."|||-0.304|-2.569|0.0129
72488469|NCT01431274|144505165|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.056|STANDARD_ERROR_OF_MEAN|0.574||0.9222|TWO_SIDED|95.0|-1.182|1.07||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||1.070|-1.182|0.9222
72488470|NCT01431274|144505165|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.029|STANDARD_ERROR_OF_MEAN|0.576||0.9602|TWO_SIDED|95.0|-1.157|1.1||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|ANCOVA|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (5 µg).~Spatial power covariance structure for within-patient errors."|||1.100|-1.157|0.9602
72515746|NCT01763866|144562674|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-61.8|STANDARD_ERROR_OF_MEAN|5.0|<|0.001|TWO_SIDED|95.0|-71.6|-52.0||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-52.0|-71.6|<0.001
72515747|NCT01763866|144562674|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-49.0|STANDARD_ERROR_OF_MEAN|6.3|<|0.001|TWO_SIDED|95.0|-61.5|-36.6||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-36.6|-61.5|<0.001
72515748|NCT01763866|144562674|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-35.3|STANDARD_ERROR_OF_MEAN|5.0|<|0.001|TWO_SIDED|95.0|-45.2|-25.5||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-25.5|-45.2|<0.001
72515749|NCT01763866|144562674|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-77.1|STANDARD_ERROR_OF_MEAN|4.6|<|0.001|TWO_SIDED|95.0|-86.2|-67.9||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-67.9|-86.2|<0.001
72515750|NCT01763866|144562674|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-75.8|STANDARD_ERROR_OF_MEAN|5.3|<|0.001|TWO_SIDED|95.0|-86.3|-65.3||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-65.3|-86.3|<0.001
72515751|NCT01763866|144562674|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-57.2|STANDARD_ERROR_OF_MEAN|4.0|<|0.001|TWO_SIDED|95.0|-65.1|-49.4||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-49.4|-65.1|<0.001
72515752|NCT01763866|144562674|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-44.6|STANDARD_ERROR_OF_MEAN|5.7|<|0.001|TWO_SIDED|95.0|-55.9|-33.4||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-33.4|-55.9|<0.001
72515753|NCT01763866|144562674|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-79.0|STANDARD_ERROR_OF_MEAN|4.3|<|0.001|TWO_SIDED|95.0|-87.5|-70.4||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-70.4|-87.5|<0.001
72515754|NCT01763866|144562674|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-71.9|STANDARD_ERROR_OF_MEAN|6.0|<|0.001|TWO_SIDED|95.0|-83.8|-60.0||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit||||-60.0|-83.8|<0.001
72403959|NCT01405963|144314343|OTHER||Treatment Difference|10.27||||0.06|TWO_SIDED|95.0|-0.46|21.0|||ANCOVA|Model includes treatment, visit, treatment by visit interaction as fixed effects and Day -14 value as covariate.|Treatment difference estimate (tezepelumab minus placebo) is mean estimate based on ANCOVA.|Treatment difference in early asthmatic response at day 84 was evaluated using a repeated-measures ANCOVA that included study treatment and study visit as independent variables, treatment by study visit as an interaction term, and the corresponding baseline value (as measured 14 days before the first dose of a study drug) as a model covariate.||21.00|-0.46|0.06
72403960|NCT01405963|144314344|OTHER||Treatment Difference|-6.08||||0.03|TWO_SIDED|95.0|-11.56|-0.6|||ANCOVA|Model includes treatment, visit, treatment by visit interaction as fixed effects and day -14 value as covariate.|Treatment difference estimate (tezepelumab minus placebo) is mean estimate based on ANCOVA.|Treatment difference in early asthmatic response at day 42 was evaluated using a repeated-measures ANCOVA that included study treatment and study visit as independent variables, treatment by study visit as an interaction term, and the corresponding baseline value (as measured 14 days before the first dose of a study drug) as a model covariate.||-0.60|-11.56|0.03
72515755|NCT01763866|144562675|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-60.28|STANDARD_ERROR_OF_MEAN|2.54|<|0.001|TWO_SIDED|95.0|-65.29|-55.27||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-55.27|-65.29|<0.001
72515756|NCT01763866|144562675|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-57.37|STANDARD_ERROR_OF_MEAN|2.97|<|0.001|TWO_SIDED|95.0|-63.23|-51.51||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-51.51|-63.23|<0.001
72515757|NCT01763866|144562675|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-32.77|STANDARD_ERROR_OF_MEAN|2.57|<|0.001|TWO_SIDED|95.0|-37.84|-27.7||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-27.70|-37.84|<0.001
72515758|NCT01763866|144562675|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-39.53|STANDARD_ERROR_OF_MEAN|2.95|<|0.001|TWO_SIDED|95.0|-45.34|-33.71||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-33.71|-45.34|<0.001
72515759|NCT01763866|144562675|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-65.17|STANDARD_ERROR_OF_MEAN|4.37|<|0.001|TWO_SIDED|95.0|-73.78|-56.56||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-56.56|-73.78|<0.001
72515760|NCT01763866|144562675|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-64.76|STANDARD_ERROR_OF_MEAN|3.84|<|0.001|TWO_SIDED|95.0|-72.32|-57.19||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-57.19|-72.32|<0.001
72624313|NCT00863304|144778628|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.43|STANDARD_ERROR_OF_MEAN|0.25||0.082|TWO_SIDED|95.0|-0.91|0.06||P-value was based on pairwise comparisons.|ANCOVA|||Week 12: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||0.06|-0.91|0.082
72515761|NCT01763866|144562675|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-38.25|STANDARD_ERROR_OF_MEAN|4.28|<|0.001|TWO_SIDED|95.0|-46.68|-29.81||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-29.81|-46.68|<0.001
72515762|NCT01763866|144562675|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-37.52|STANDARD_ERROR_OF_MEAN|3.87|<|0.001|TWO_SIDED|95.0|-45.15|-29.9||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-29.90|-45.15|<0.001
72515763|NCT01763866|144562675|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-59.61|STANDARD_ERROR_OF_MEAN|2.6|<|0.001|TWO_SIDED|95.0|-64.73|-54.48||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-54.48|-64.73|<0.001
72515764|NCT01763866|144562675|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-59.2|STANDARD_ERROR_OF_MEAN|2.83|<|0.001|TWO_SIDED|95.0|-64.8|-53.6||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-53.60|-64.80|<0.001
72515765|NCT01763866|144562675|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-58.27|STANDARD_ERROR_OF_MEAN|3.2|<|0.001|TWO_SIDED|95.0|-64.6|-51.94||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-51.94|-64.60|<0.001
72624314|NCT00863304|144778629|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.22||0.001|TWO_SIDED|95.0|-1.12|-0.27||P-value was based on pairwise comparisons.|ANCOVA|||Week 2: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.27|-1.12|0.001
72403961|NCT01405963|144314344|OTHER||Treatment Difference|-7.44||||0.03|TWO_SIDED|95.0|-14.22|-0.66|||ANCOVA|Model includes treatment, visit, treatment by visit interaction as fixed effects and day -14 value as covariate.|Treatment difference estimate (tezepelumab minus placebo) is mean estimate based on ANCOVA.|Treatment difference in early asthmatic response at day 84 was evaluated using a repeated-measures ANCOVA that included study treatment and study visit as independent variables, treatment by study visit as an interaction term, and the corresponding baseline value (as measured 14 days before the first dose of a study drug) as a model covariate.||-0.66|-14.22|0.03
72403962|NCT01405963|144314345|OTHER||Treatment Difference|0.33||||0.05|TWO_SIDED|95.0|-0.01|0.68|||ANCOVA|Model includes treatment, visit, treatment by visit interaction as fixed effects and Day -14 value as covariate.|Treatment difference estimate (tezepelumab minus placebo) is mean estimate based on ANCOVA.|Treatment difference in early asthmatic response at day 42 was evaluated using a repeated-measures ANCOVA that included study treatment and study visit as independent variables, treatment by study visit as an interaction term, and the corresponding baseline value (as measured 14 days before the first dose of a study drug) as a model covariate.||0.68|-0.01|0.05
72488471|NCT01431274|144505165|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.415|STANDARD_ERROR_OF_MEAN|0.57||0.4669|TWO_SIDED|95.0|-1.533|0.703||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tio+Olo FDC (2.5/5 µg).~Spatial power covariance structure for within-patient errors."|||0.703|-1.533|0.4669
72488472|NCT01431274|144505165|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.471|STANDARD_ERROR_OF_MEAN|0.575||0.4126|TWO_SIDED|95.0|-1.598|0.656||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.656|-1.598|0.4126
72488473|NCT01431274|144505165|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.408|STANDARD_ERROR_OF_MEAN|0.583||0.0158|TWO_SIDED|95.0|-2.551|-0.265||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within-patient errors."|||-0.265|-2.551|0.0158
72488474|NCT01431274|144505165|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.381|STANDARD_ERROR_OF_MEAN|0.582||0.0177|TWO_SIDED|95.0|-2.521|-0.24||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (2.5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within-patient errors."|||-0.240|-2.521|0.0177
72488475|NCT01431274|144505165|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.027|STANDARD_ERROR_OF_MEAN|0.58||0.9624|TWO_SIDED|95.0|-1.164|1.109||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||1.109|-1.164|0.9624
72488476|NCT01431274|144505166|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.595|STANDARD_ERROR_OF_MEAN|0.136|<|0.0001|TWO_SIDED|95.0|0.329|0.862||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within-patient errors."|||0.862|0.329|<0.0001
72488477|NCT01431274|144505166|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.64|STANDARD_ERROR_OF_MEAN|0.136|<|0.0001|TWO_SIDED|95.0|0.373|0.907||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Tiotropium (5 μg).~Spatial power covariance structure for within-patient errors."|||0.907|0.373|<0.0001
72515766|NCT01763866|144562675|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-57.31|STANDARD_ERROR_OF_MEAN|3.53|<|0.001|TWO_SIDED|95.0|-64.29|-50.32||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-50.32|-64.29|<0.001
72515767|NCT01763866|144562675|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-60.06|STANDARD_ERROR_OF_MEAN|2.59|<|0.001|TWO_SIDED|95.0|-65.18|-54.94||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-54.94|-65.18|<0.001
72515768|NCT01763866|144562675|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-62.82|STANDARD_ERROR_OF_MEAN|3.75|<|0.001|TWO_SIDED|95.0|-70.22|-55.42||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit||||-55.42|-70.22|<0.001
72515769|NCT01763866|144562676|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-61.64|STANDARD_ERROR_OF_MEAN|2.84|<|0.001|TWO_SIDED|95.0|-67.25|-56.03||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-56.03|-67.25|<0.001
72577148|NCT02045147|144680868|OTHER||Median Difference (Final Values)|-10.5|STANDARD_ERROR_OF_MEAN|7.45||0.169|TWO_SIDED|95.0|-25.86|4.77|||t-test, 2 sided|||||4.77|-25.86|0.169
72403963|NCT01405963|144314345|OTHER||Treatment Difference|0.39||||0.08|TWO_SIDED|95.0|-0.06|0.84|||ANCOVA|Model includes treatment, visit, treatment by visit interaction as fixed effects and Day -14 value as covariate.|Treatment difference estimate (tezepelumab minus placebo) is mean estimate based on ANCOVA.|Treatment difference in early asthmatic response at day 84 was evaluated using a repeated-measures ANCOVA that included study treatment and study visit as independent variables, treatment by study visit as an interaction term, and the corresponding baseline value (as measured 14 days before the first dose of a study drug) as a model covariate.||0.84|-0.06|0.08
72403964|NCT01405963|144314346|OTHER||Treatment Difference|0.28||||0.03|TWO_SIDED|95.0|0.03|0.53|||ANCOVA|Model includes treatment, visit, treatment by visit interaction as fixed effects and day -14 value as covariate.|Treatment difference estimate (tezepelumab minus placebo) is mean estimate based on ANCOVA.|Treatment difference in early asthmatic response at day 42 was evaluated using a repeated-measures ANCOVA that included study treatment and study visit as independent variables, treatment by study visit as an interaction term, and the corresponding baseline value (as measured 14 days before the first dose of a study drug) as a model covariate.||0.53|0.03|0.03
72403965|NCT01405963|144314346|OTHER||Treatment Difference|0.33||||0.06|TWO_SIDED|95.0|-0.01|0.66|||ANCOVA|Model includes treatment, visit, treatment by visit interaction as fixed effects and day -14 value as covariate.|Treatment difference estimate (tezepelumab minus placebo) is mean estimate based on ANCOVA.|Treatment difference in early asthmatic response at day 84 was evaluated using a repeated-measures ANCOVA that included study treatment and study visit as independent variables, treatment by study visit as an interaction term, and the corresponding baseline value (as measured 14 days before the first dose of a study drug) as a model covariate.||0.66|-0.01|0.06
72403966|NCT01405963|144314347|OTHER||Treatment Difference|0.41||||0.01|TWO_SIDED|95.0|0.12|0.7|||ANCOVA|Model includes treatment, visit, treatment by visit interaction as fixed effects and Day -14 value as covariate.|Treatment difference estimate (tezepelumab minus placebo) is mean estimate based on ANCOVA.|Treatment difference in late asthmatic response at day 42 was evaluated using a repeated-measures ANCOVA that included study treatment and study visit as independent variables, treatment by study visit as an interaction term, and the corresponding baseline value (as measured 14 days before the first dose of a study drug) as a model covariate.||0.70|0.12|0.01
72403967|NCT01405963|144314347|OTHER||Treatment Difference|0.42||||0.01|TWO_SIDED|95.0|0.11|0.72|||ANCOVA|Model includes treatment, visit, treatment by visit interaction as fixed effects and Day -14 value as covariate.|Treatment difference estimate (tezepelumab minus placebo) is mean estimate based on ANCOVA.|Treatment difference in late asthmatic response at day 84 was evaluated using a repeated-measures ANCOVA that included study treatment and study visit as independent variables, treatment by study visit as an interaction term, and the corresponding baseline value (as measured 14 days before the first dose of a study drug) as a model covariate.||0.72|0.11|0.01
72403968|NCT01405963|144314348|OTHER||Treatment Difference|0.24||||0.02|TWO_SIDED|95.0|0.04|0.45|||ANCOVA|Model includes treatment, visit, treatment by visit interaction as fixed effects and day -14 value as covariate.|Treatment difference estimate (tezepelumab minus placebo) is mean estimate based on ANCOVA.|Treatment difference in late asthmatic response at day 42 was evaluated using a repeated-measures ANCOVA that included study treatment and study visit as independent variables, treatment by study visit as an interaction term, and the corresponding baseline value (as measured 14 days before the first dose of a study drug) as a model covariate.||0.45|0.04|0.02
72403969|NCT01405963|144314348|OTHER||Treatment Difference|0.18||||0.15|TWO_SIDED|95.0|-0.07|0.44|||ANCOVA|Model includes treatment, visit, treatment by visit interaction as fixed effects and day -14 value as covariate.|Treatment difference estimate (tezepelumab minus placebo) is mean estimate based on ANCOVA.|Treatment difference in late asthmatic response at day 84 was evaluated using a repeated-measures ANCOVA that included study treatment and study visit as independent variables, treatment by study visit as an interaction term, and the corresponding baseline value (as measured 14 days before the first dose of a study drug) as a model covariate.||0.44|-0.07|0.15
72515770|NCT01763866|144562676|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-54.93|STANDARD_ERROR_OF_MEAN|3.28|<|0.001|TWO_SIDED|95.0|-61.4|-48.46||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-48.46|-61.40|<0.001
72515771|NCT01763866|144562676|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-35.11|STANDARD_ERROR_OF_MEAN|2.88|<|0.001|TWO_SIDED|95.0|-40.79|-29.44||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-29.44|-40.79|<0.001
72515772|NCT01763866|144562676|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-37.72|STANDARD_ERROR_OF_MEAN|3.26|<|0.001|TWO_SIDED|95.0|-44.15|-31.3||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-31.30|-44.15|<0.001
72515773|NCT01763866|144562676|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-66.64|STANDARD_ERROR_OF_MEAN|4.69|<|0.001|TWO_SIDED|95.0|-75.88|-57.39||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-57.39|-75.88|<0.001
72568505|NCT00688376|144668410|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|2.5||||0.4385|TWO_SIDED|95.0|-3.97|9.04|||ANCOVA|||RTSS Change from Baseline to Week 6 (LOCF). P-values, LS mean, and 95% confidence intervals were obtained from ANCOVA model with treatment group as a factor and baseline value as covariate.||9.04|-3.97|0.4385
72568506|NCT00688376|144668410|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.4||||0.9088|TWO_SIDED|95.0|-6.74|6.0|||ANCOVA|||RTSS Change from Baseline to Week 12 (LOCF). P-values, LS mean, and 95% confidence intervals were obtained from ANCOVA model with treatment group as a factor and baseline value as covariate.||6|-6.74|0.9088
72577149|NCT02045147|144680868|OTHER||Mean Difference (Final Values)|-3.7|STANDARD_ERROR_OF_MEAN|4.52||0.416|TWO_SIDED|95.0|-12.79|5.37|||t-test, 2 sided|||||5.37|-12.79|0.416
72515774|NCT01763866|144562676|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-60.01|STANDARD_ERROR_OF_MEAN|4.3|<|0.001|TWO_SIDED|95.0|-68.49|-51.52||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-51.52|-68.49|<0.001
72515775|NCT01763866|144562676|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-40.51|STANDARD_ERROR_OF_MEAN|4.59|<|0.001|TWO_SIDED|95.0|-49.55|-31.47||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-31.47|-49.55|<0.001
72515776|NCT01763866|144562676|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-32.79|STANDARD_ERROR_OF_MEAN|4.32|<|0.001|TWO_SIDED|95.0|-41.3|-24.28||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-24.28|-41.30|<0.001
72515777|NCT01763866|144562676|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-59.96|STANDARD_ERROR_OF_MEAN|2.95|<|0.001|TWO_SIDED|95.0|-65.78|-54.13||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-54.13|-65.78|<0.001
72515778|NCT01763866|144562676|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-57.42|STANDARD_ERROR_OF_MEAN|2.96|<|0.001|TWO_SIDED|95.0|-63.27|-51.57||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-51.57|-63.27|<0.001
72515779|NCT01763866|144562676|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-59.58|STANDARD_ERROR_OF_MEAN|3.73|<|0.001|TWO_SIDED|95.0|-66.95|-52.21||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-52.21|-66.95|<0.001
72515780|NCT01763866|144562676|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-49.76|STANDARD_ERROR_OF_MEAN|4.3|<|0.001|TWO_SIDED|95.0|-58.26|-41.27||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-41.27|-58.26|<0.001
72515781|NCT01763866|144562676|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-60.91|STANDARD_ERROR_OF_MEAN|2.87|<|0.001|TWO_SIDED|95.0|-66.57|-55.24||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-55.24|-66.57|<0.001
72515782|NCT01763866|144562676|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-56.63|STANDARD_ERROR_OF_MEAN|4.06|<|0.001|TWO_SIDED|95.0|-64.63|-48.62||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit||||-48.62|-64.63|<0.001
72515783|NCT01763866|144562677|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-58.49|STANDARD_ERROR_OF_MEAN|2.34|<|0.001|TWO_SIDED|95.0|-63.1|-53.89||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-53.89|-63.10|<0.001
72515784|NCT01763866|144562677|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-52.25|STANDARD_ERROR_OF_MEAN|2.66|<|0.001|TWO_SIDED|95.0|-57.49|-47.01||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-47.01|-57.49|<0.001
72515785|NCT01763866|144562677|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-33.66|STANDARD_ERROR_OF_MEAN|2.37|<|0.001|TWO_SIDED|95.0|-38.33|-28.98||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-28.98|-38.33|<0.001
72515786|NCT01763866|144562677|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-40.01|STANDARD_ERROR_OF_MEAN|2.67|<|0.001|TWO_SIDED|95.0|-45.27|-34.74||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-34.74|-45.27|<0.001
72515787|NCT01763866|144562677|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-59.34|STANDARD_ERROR_OF_MEAN|3.69|<|0.001|TWO_SIDED|95.0|-66.61|-52.07||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-52.07|-66.61|<0.001
72515788|NCT01763866|144562677|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-58.74|STANDARD_ERROR_OF_MEAN|3.46|<|0.001|TWO_SIDED|95.0|-65.56|-51.93||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-51.93|-65.56|<0.001
72403970|NCT04544293|144314363|SUPERIORITY||Mean Difference (Net)|6.0||||0.0007|TWO_SIDED|95.0|2.5|9.4|||Mixed Models Analysis|Modelled using MMRM adjusted for baseline % predicted DLCOadj, treatment, visit, region, severity stratification and treatment-visit interaction.|Difference from placebo|||9.4|2.5|0.0007
72515789|NCT01763866|144562677|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-34.92|STANDARD_ERROR_OF_MEAN|3.64|<|0.001|TWO_SIDED|95.0|-42.09|-27.75||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-27.75|-42.09|<0.001
72515790|NCT01763866|144562677|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-39.64|STANDARD_ERROR_OF_MEAN|3.52|<|0.001|TWO_SIDED|95.0|-46.57|-32.71||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-32.71|-46.57|<0.001
72515791|NCT01763866|144562677|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-54.86|STANDARD_ERROR_OF_MEAN|2.43|<|0.001|TWO_SIDED|95.0|-59.66|-50.05||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-50.05|-59.66|<0.001
72515792|NCT01763866|144562677|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-56.14|STANDARD_ERROR_OF_MEAN|2.29|<|0.001|TWO_SIDED|95.0|-60.66|-51.61||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-51.61|-60.66|<0.001
72515793|NCT01763866|144562677|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-50.78|STANDARD_ERROR_OF_MEAN|3.01|<|0.001|TWO_SIDED|95.0|-56.72|-44.83||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-44.83|-56.72|<0.001
72515794|NCT01763866|144562677|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-54.94|STANDARD_ERROR_OF_MEAN|3.12|<|0.001|TWO_SIDED|95.0|-61.11|-48.76||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-48.76|-61.11|<0.001
72515795|NCT01763866|144562677|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-55.34|STANDARD_ERROR_OF_MEAN|2.33|<|0.001|TWO_SIDED|95.0|-59.94|-50.74||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-50.74|-59.94|<0.001
72515796|NCT01763866|144562677|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-56.87|STANDARD_ERROR_OF_MEAN|3.24|<|0.001|TWO_SIDED|95.0|-63.27|-50.46||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit||||-50.46|-63.27|<0.001
72488478|NCT01431274|144505166|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.423|STANDARD_ERROR_OF_MEAN|0.136||0.0019|TWO_SIDED|95.0|0.156|0.69||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within-patient errors."|||0.690|0.156|0.0019
72488479|NCT01431274|144505166|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.446|STANDARD_ERROR_OF_MEAN|0.136||0.0011|TWO_SIDED|95.0|0.179|0.712||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.712|0.179|0.0011
72515797|NCT01763866|144562678|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-58.79|STANDARD_ERROR_OF_MEAN|2.66|<|0.001|TWO_SIDED|95.0|-64.03|-53.55||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-53.55|-64.03|<0.001
72515798|NCT01763866|144562678|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-47.36|STANDARD_ERROR_OF_MEAN|2.96|<|0.001|TWO_SIDED|95.0|-53.2|-41.52||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-41.52|-53.20|<0.001
72488480|NCT01431274|144505166|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.468|STANDARD_ERROR_OF_MEAN|0.136||0.0006|TWO_SIDED|95.0|0.201|0.735||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (5 µg).~Spatial power covariance structure for within-patient errors."|||0.735|0.201|0.0006
72515799|NCT01763866|144562678|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-34.92|STANDARD_ERROR_OF_MEAN|2.69|<|0.001|TWO_SIDED|95.0|-40.23|-29.6||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-29.60|-40.23|<0.001
72515800|NCT01763866|144562678|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-36.21|STANDARD_ERROR_OF_MEAN|2.97|<|0.001|TWO_SIDED|95.0|-42.06|-30.35||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-30.35|-42.06|<0.001
72403971|NCT04544293|144314364|SUPERIORITY||Mean Difference (Net)|6.9||||0.0008|TWO_SIDED|95.0|2.9|10.9||Modelled using MMRM adjusted for baseline % predicted DLCOadj, treatment, visit, region, severity stratification and treatment-visit interaction.|Mixed Models Analysis||Difference from Placebo|||10.9|2.9|0.0008
72403972|NCT04544293|144314365|SUPERIORITY||Mean Difference (Net)|-6.59||||0.0072|TWO_SIDED|95.0|-11.4|-1.79|||Mixed Models Analysis|||||-1.79|-11.40|0.0072
72403973|NCT04544293|144314366|SUPERIORITY||Mean Difference (Net)|-7.81||||0.0149|TWO_SIDED|95.0|-14.1|-1.52|||Mixed Models Analysis|||||-1.52|-14.10|0.0149
72488481|NCT01431274|144505166|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.172|STANDARD_ERROR_OF_MEAN|0.136||0.2045|TWO_SIDED|95.0|-0.094|0.438||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tio+Olo FDC (2.5/5 µg).~Spatial power covariance structure for within-patient errors."|||0.438|-0.094|0.2045
72488482|NCT01431274|144505166|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.618|STANDARD_ERROR_OF_MEAN|0.136|<|0.0001|TWO_SIDED|95.0|0.351|0.885||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.885|0.351|<0.0001
72488483|NCT01431274|144505166|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.045|STANDARD_ERROR_OF_MEAN|0.137||0.7432|TWO_SIDED|95.0|-0.313|0.223||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within-patient errors."|||0.223|-0.313|0.7432
72488484|NCT01431274|144505166|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.023|STANDARD_ERROR_OF_MEAN|0.136||0.8687|TWO_SIDED|95.0|-0.29|0.245||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (2.5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within-patient errors."|||0.245|-0.290|0.8687
72403974|NCT04544293|144314367|SUPERIORITY||Mean Difference (Final Values)|0.41||||0.0845|TWO_SIDED|95.0|-0.06|0.89|||Mixed Models Analysis|||||0.89|-0.06|0.0845
72403975|NCT04544293|144314368|SUPERIORITY||Mean Difference (Net)|-4.87||||0.1046|TWO_SIDED|95.0|-10.76|1.01|||Mixed Models Analysis|||||1.01|-10.76|0.1046
72488485|NCT01431274|144505166|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.022|STANDARD_ERROR_OF_MEAN|0.137||0.8709|TWO_SIDED|95.0|-0.29|0.246||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.246|-0.290|0.8709
72515801|NCT01763866|144562678|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-61.4|STANDARD_ERROR_OF_MEAN|3.99|<|0.001|TWO_SIDED|95.0|-69.27|-53.54||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-53.54|-69.27|<0.001
72515802|NCT01763866|144562678|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-53.01|STANDARD_ERROR_OF_MEAN|3.93|<|0.001|TWO_SIDED|95.0|-60.77|-45.25||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-45.25|-60.77|<0.001
72568507|NCT00688376|144668411|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.7||||0.2886|TWO_SIDED|95.0|-1.5|4.96|||ANCOVA|||Global Executive Composite Score Analysis. P-values, LS mean, and 95% confidence intervals were obtained from ANCOVA model with treatment group as a factor and baseline value as covariate.||4.96|-1.5|0.2886
72403976|NCT04544293|144314369|SUPERIORITY||Mean Difference (Net)|-5.99||||0.1216|TWO_SIDED|95.0|-13.57|1.59|||Mixed Models Analysis|||||1.59|-13.57|0.1216
72403977|NCT04544293|144314370|SUPERIORITY||Mean Difference (Final Values)|0.55||||0.0234|TWO_SIDED|95.0|0.07|1.03|||Mixed Models Analysis||Change from baseline compared to placebo.|||1.03|0.07|0.0234
72403978|NCT04544293|144314371|SUPERIORITY||Mean Difference (Final Values)|-4.01||||0.1043|TWO_SIDED|95.0|-8.84|0.83|||Mixed Models Analysis|||||0.83|-8.84|0.1043
72403979|NCT00329407|144314377|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.7|STANDARD_ERROR_OF_MEAN|0.8|<|0.0001|TWO_SIDED|95.0|-6.58|-3.14|||Mixed Models Analysis|The Dunnett-Hsu adjustment was used to correct for multiple comparisons.||This was a within subject analysis. The null hypothesis was that there would be no significant difference in least squares means values obtained for the baseline and week 10 assessment weeks.||-3.14|-6.58|<0.0001
72488486|NCT01431274|144505167|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.63|STANDARD_ERROR_OF_MEAN|0.137|<|0.0001|TWO_SIDED|95.0|0.362|0.898||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within-patient errors."|||0.898|0.362|<0.0001
72488487|NCT01431274|144505167|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.434|STANDARD_ERROR_OF_MEAN|0.137||0.0015|TWO_SIDED|95.0|0.166|0.703||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Tiotropium (5 μg).~Spatial power covariance structure for within-patient errors."|||0.703|0.166|0.0015
72403980|NCT00329407|144314378|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-11.0|STANDARD_ERROR_OF_MEAN|2.7||0.001|ONE_SIDED|95.0||||There would a significant reduction in COWAT scores between baseline and Week 10.|Mixed Models Analysis|The Dunnett-Hsu adjustment was used to correct for multiple comparisons.||This is a within subject comparison of COWAT scores botained for the baseline session and the Week 10 session. The null hypothesis is that there would be no difference between these scores.||||0.001
72403981|NCT04681482|144314400|SUPERIORITY||Hazard Ratio (HR)|0.62|||<|0.001|TWO_SIDED|95.0|0.54|0.7|||Cox Proportional Hazards Model|||Cox Proportional Hazards Model was used to compare the risk of MB between cohorts.||0.70|0.54|<0.001
72403982|NCT04681482|144314402|SUPERIORITY||Hazard Ratio (HR)|0.82||||0.088|TWO_SIDED|95.0|0.66|1.03|||Cox Proportional Hazards Model|||Cox Proportional Hazards Model was used to compare the risk of stroke/SE between cohorts.||1.03|0.66|0.088
72488488|NCT01431274|144505167|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.419|STANDARD_ERROR_OF_MEAN|0.137||0.0022|TWO_SIDED|95.0|0.151|0.687||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within-patient errors."|||0.687|0.151|0.0022
72488489|NCT01431274|144505167|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.227|STANDARD_ERROR_OF_MEAN|0.137||0.0966|TWO_SIDED|95.0|-0.041|0.495||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.495|-0.041|0.0966
72488490|NCT01431274|144505167|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.223|STANDARD_ERROR_OF_MEAN|0.137||0.1029|TWO_SIDED|95.0|-0.045|0.492||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (5 µg).~Spatial power covariance structure for within-patient errors."|||0.492|-0.045|0.1029
72488491|NCT01431274|144505167|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.211|STANDARD_ERROR_OF_MEAN|0.136||0.122|TWO_SIDED|95.0|-0.056|0.478||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tio+Olo FDC (2.5/5 µg).~Spatial power covariance structure for within-patient errors."|||0.478|-0.056|0.1220
72488492|NCT01431274|144505167|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.438|STANDARD_ERROR_OF_MEAN|0.137||0.0014|TWO_SIDED|95.0|0.17|0.707||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.707|0.170|0.0014
72488493|NCT01431274|144505167|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.196|STANDARD_ERROR_OF_MEAN|0.137||0.1542|TWO_SIDED|95.0|-0.074|0.465||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within-patient errors."|||0.465|-0.074|0.1542
72488494|NCT01431274|144505167|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.192|STANDARD_ERROR_OF_MEAN|0.137||0.1626|TWO_SIDED|95.0|-0.077|0.461||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (2.5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within-patient errors."|||0.461|-0.077|0.1626
72488495|NCT01431274|144505167|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.004|STANDARD_ERROR_OF_MEAN|0.138||0.9765|TWO_SIDED|95.0|-0.265|0.274||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.274|-0.265|0.9765
72488496|NCT01431274|144505168|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.647|STANDARD_ERROR_OF_MEAN|0.142|<|0.0001|TWO_SIDED|95.0|0.37|0.925||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within-patient errors."|||0.925|0.370|<0.0001
72488497|NCT01431274|144505168|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.322|STANDARD_ERROR_OF_MEAN|0.141||0.0226|TWO_SIDED|95.0|0.045|0.6||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Tiotropium (5 μg).~Spatial power covariance structure for within-patient errors."|||0.600|0.045|0.0226
72403983|NCT04681482|144314404|SUPERIORITY||Hazard Ratio (HR)|0.67|||<|0.001|TWO_SIDED|95.0|0.6|0.76|||Cox Proportional Hazards Model|||Cox Proportional Hazards Model was used to compare the risk of net clinical benefit between cohorts.||0.76|0.60|<0.001
72403984|NCT03608774|144314408|SUPERIORITY||Risk Difference (RD)|0.26|||<|0.001|TWO_SIDED|95.0|0.16|0.36||Protocol pre-specified an interim analysis of the primary outcome using O'Brien-Fleming bounds to maintain an overall 5% alpha level. The trial was stopped at the interim analysis. P-value was derived using stage-wise ordering of the sample space.|Chi-squared||Protocol pre-specified an interim analysis of the primary outcome using O'Brien-Fleming bounds to maintain an overall 5% alpha level. The trial was stopped at the interim analysis. Estimates were derived using stage-wise ordering of the sample space.|||0.36|0.16|<0.001
72488498|NCT01431274|144505168|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.371|STANDARD_ERROR_OF_MEAN|0.142||0.0089|TWO_SIDED|95.0|0.093|0.649||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within-patient errors."|||0.649|0.093|0.0089
72403985|NCT03608774|144314409|OTHER||Risk Difference (RD)|0.11|||||TWO_SIDED|95.0|0.0|0.22||||||||0.22|0.00|
72488499|NCT01431274|144505168|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.332|STANDARD_ERROR_OF_MEAN|0.141||0.0186|TWO_SIDED|95.0|0.056|0.609||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.609|0.056|0.0186
72403986|NCT03608774|144314410|OTHER||Risk Difference (RD)|0.1|||||TWO_SIDED|95.0|-0.01|0.21||||||||0.21|-0.01|
72488500|NCT01431274|144505168|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.046|STANDARD_ERROR_OF_MEAN|0.142||0.7441|TWO_SIDED|95.0|-0.231|0.324||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (5 µg).~Spatial power covariance structure for within-patient errors."|||0.324|-0.231|0.7441
72488501|NCT01431274|144505168|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.276|STANDARD_ERROR_OF_MEAN|0.14||0.0492|TWO_SIDED|95.0|0.001|0.551||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tio+Olo FDC (2.5/5 μg).~Spatial power covariance structure for within-patient errors."|||0.551|0.001|0.0492
72488502|NCT01431274|144505168|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.608|STANDARD_ERROR_OF_MEAN|0.141|<|0.0001|TWO_SIDED|95.0|0.332|0.884||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.884|0.332|<0.0001
72515803|NCT01763866|144562678|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-37.45|STANDARD_ERROR_OF_MEAN|3.91|<|0.001|TWO_SIDED|95.0|-45.17|-29.74||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-29.74|-45.17|<0.001
72515804|NCT01763866|144562678|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-34.31|STANDARD_ERROR_OF_MEAN|3.98|<|0.001|TWO_SIDED|95.0|-42.15|-26.47||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-26.47|-42.15|<0.001
72515805|NCT01763866|144562678|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-56.5|STANDARD_ERROR_OF_MEAN|2.58|<|0.001|TWO_SIDED|95.0|-61.6|-51.4||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-51.40|-61.60|<0.001
72515806|NCT01763866|144562678|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-53.21|STANDARD_ERROR_OF_MEAN|2.57|<|0.001|TWO_SIDED|95.0|-58.29|-48.13||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-48.13|-58.29|<0.001
72515807|NCT01763866|144562678|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-50.52|STANDARD_ERROR_OF_MEAN|3.31|<|0.001|TWO_SIDED|95.0|-57.06|-43.99||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-43.99|-57.06|<0.001
72403987|NCT03608774|144314411|OTHER||Risk Difference (RD)|0.26|||||TWO_SIDED|95.0|0.15|0.38||||||||0.38|0.15|
72403988|NCT03608774|144314412|OTHER||Risk Difference (RD)|0.25|||||TWO_SIDED|95.0|-0.28|0.7||||||||0.70|-0.28|
72403989|NCT03608774|144314413|OTHER||Risk Difference (RD)|0.25|||||TWO_SIDED|95.0|-0.28|0.7||||||||0.70|-0.28|
72403990|NCT02531321|144314450|OTHER|Unpaired t test with Welch's correction|||||<|0.05|||||||t-test, 2 sided|||||||<.05
72488503|NCT01431274|144505168|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.325|STANDARD_ERROR_OF_MEAN|0.143||0.023|TWO_SIDED|95.0|0.045|0.605||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (2.5 µg) versus Olodaterol (5 µg)~Spatial power covariance structure for within-patient errors."|||0.605|0.045|0.0230
72515808|NCT01763866|144562678|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-46.95|STANDARD_ERROR_OF_MEAN|3.78|<|0.001|TWO_SIDED|95.0|-54.43|-39.47||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-39.47|-54.43|<0.001
72515809|NCT01763866|144562678|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-56.3|STANDARD_ERROR_OF_MEAN|2.61|<|0.001|TWO_SIDED|95.0|-61.47|-51.14||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-51.14|-61.47|<0.001
72515810|NCT01763866|144562678|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-52.73|STANDARD_ERROR_OF_MEAN|3.38|<|0.001|TWO_SIDED|95.0|-59.4|-46.06||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit||||-46.06|-59.40|<0.001
72403991|NCT03200899|144314465|SUPERIORITY|||||||0.926|||||||ANCOVA|||||||0.926
72488504|NCT01431274|144505168|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.039|STANDARD_ERROR_OF_MEAN|0.142||0.7855|TWO_SIDED|95.0|-0.24|0.317||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (2.5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within-patient errors."|||0.317|-0.240|0.7855
72488505|NCT01431274|144505168|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.286|STANDARD_ERROR_OF_MEAN|0.142||0.0442|TWO_SIDED|95.0|0.007|0.564||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (2.5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within-patient errors."|||0.564|0.007|0.0442
72515811|NCT01763866|144562679|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-46.41|STANDARD_ERROR_OF_MEAN|2.16|<|0.001|TWO_SIDED|95.0|-50.66|-42.15||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-42.15|-50.66|<0.001
72515812|NCT01763866|144562679|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-44.69|STANDARD_ERROR_OF_MEAN|2.57|<|0.001|TWO_SIDED|95.0|-49.75|-39.63||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-39.63|-49.75|<0.001
72515813|NCT01763866|144562679|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-26.06|STANDARD_ERROR_OF_MEAN|2.19|<|0.001|TWO_SIDED|95.0|-30.36|-21.75||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-21.75|-30.36|<0.001
72515814|NCT01763866|144562679|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-31.59|STANDARD_ERROR_OF_MEAN|2.55|<|0.001|TWO_SIDED|95.0|-36.61|-26.57||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-26.57|-36.61|<0.001
72515815|NCT01763866|144562679|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-44.48|STANDARD_ERROR_OF_MEAN|3.15|<|0.001|TWO_SIDED|95.0|-50.69|-38.27||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-38.27|-50.69|<0.001
72515816|NCT01763866|144562679|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-46.85|STANDARD_ERROR_OF_MEAN|2.86|<|0.001|TWO_SIDED|95.0|-52.48|-41.21||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-41.21|-52.48|<0.001
72515817|NCT01763866|144562679|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-28.3|STANDARD_ERROR_OF_MEAN|3.09|<|0.001|TWO_SIDED|95.0|-34.39|-22.21||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-22.21|-34.39|<0.001
72403992|NCT03200899|144314466|SUPERIORITY|||||||0.75|||||||ANCOVA|||||||0.750
72403993|NCT03200899|144314467|SUPERIORITY|||||||0.129|||||||ANCOVA|||||||0.129
72515818|NCT01763866|144562679|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-28.18|STANDARD_ERROR_OF_MEAN|2.88|<|0.001|TWO_SIDED|95.0|-33.86|-22.5||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-22.50|-33.86|<0.001
72515819|NCT01763866|144562679|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-44.73|STANDARD_ERROR_OF_MEAN|2.41|<|0.001|TWO_SIDED|95.0|-49.5|-39.97||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-39.97|-49.50|<0.001
72568508|NCT00688376|144668411|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|2.1||||0.2555|TWO_SIDED|95.0|-1.54|5.69|||ANCOVA|||Behavioral Regulation Index Analysis. P-values, LS mean, and 95% confidence intervals were obtained from ANCOVA model with treatment group as a factor and baseline value as covariate.||5.69|-1.54|0.2555
72403994|NCT03200899|144314468|SUPERIORITY|||||||0.152|||||||ANCOVA|||||||0.152
72488506|NCT01412554|144505239|OTHER|Only descriptive statistics|||||<|0.05|||||||Spearman|The degree of tracking was assessed by Spearman's rank or Pearson's correlation coefficient||Only an observational follow-up study|The degree of tracking was assessed by Spearman's rank or Pearson's correlation coefficient|||<0.05
72488507|NCT05321069|144505294|SUPERIORITY||Mean Difference (Net)|44.89||||0.0222|TWO_SIDED|95.0|6.44|83.33|||Mixed Models Analysis|The Kenward-Roger method estimated denominator degrees of freedom and adjusted standard errors; tests used two-sided α per multiple testing strategy.|Adjusted mean difference in FVC change from baseline at Week 52 between the Nera 9 mg bid group and the Placebo group.|Based on a Mixed Model for Repeated Measures (MMRM), which included fixed, categorical effects of treatment at each visit, baseline use of antifibrotic therapy at each visit, and fixed continuous effects of baseline forced vital capacity (FVC) in milliliters at each visit. Patients were treated as a random effect. Visit was treated as the repeated measure, and an unstructured covariance structure was used to model the within-patient measurements.||83.33|6.44|0.0222
72488508|NCT05321069|144505294|SUPERIORITY||Mean Difference (Net)|68.83||||0.0005|TWO_SIDED|95.0|30.26|107.39|||Mixed Models Analysis|The Kenward-Roger method estimated denominator degrees of freedom and adjusted standard errors; tests used two-sided α per multiple testing strategy.|Adjusted mean difference in FVC change from baseline at Week 52 between the Nera 18 mg bid group and the Placebo group.|Based on a Mixed Model for Repeated Measures (MMRM), which included fixed, categorical effects of treatment at each visit, baseline use of antifibrotic therapy at each visit, and fixed continuous effects of baseline forced vital capacity (FVC) in milliliters at each visit. Patients were treated as a random effect. Visit was treated as the repeated measure, and an unstructured covariance structure was used to model the within-patient measurements.||107.39|30.26|0.0005
72488509|NCT05321069|144505295|SUPERIORITY||Hazard Ratio (HR)|0.92||||0.5443|TWO_SIDED|95.0|0.69|1.22|||Regression, Cox|||The hazard ratio (HR) was estimated using a Cox proportional hazards model with treatment group, baseline antifibrotic therapy use, age (continuous), baseline FVC % predicted, and baseline DLCO % predicted (hemoglobin-corrected) as covariates. Breslow's method was applied for tied event times. A two-sided p-value from the Wald test assessed the treatment effect. P-values were not adjusted for multiplicity.||1.22|0.69|0.5443
72488510|NCT05321069|144505295|SUPERIORITY||Hazard Ratio (HR)|0.99||||0.9512|TWO_SIDED|95.0|0.75|1.31|||Regression, Cox|||Based on Cox proportional hazards model including treatment, baseline antifibrotic therapy, age, baseline Forced Vital Capacity (FVC) percent predicted, and baseline Diffusing Capacity of the Lungs for Carbon Monoxide (DLCO) percent predicted (corrected for haemoglobin) as covariates. p-values not adjusted for multiplicity.||1.31|0.75|0.9512
72488511|NCT05321069|144505296|SUPERIORITY||Hazard Ratio (HR)|1.12||||0.5583|TWO_SIDED|95.0|0.76|1.67|||Regression, Cox|||Analysis was performed using a Cox proportional hazards regression model that included baseline use of antifibrotic therapy (antifibrotic group vs non-antifibrotic group), age, baseline forced vital capacity (FVC) percentage predicted, baseline diffusing capacity of the lungs for carbon monoxide (DLCO) percentage predicted (corrected for hemoglobin levels), and treatment group as covariates.||1.67|0.76|0.5583
72403995|NCT03200899|144314469|SUPERIORITY|||||||0.037|||||||ANCOVA|||||||0.037
72488512|NCT05321069|144505296|SUPERIORITY||Hazard Ratio (HR)|1.11||||0.5896|TWO_SIDED|95.0|0.75|1.65|||Regression, Cox|||Analysis was performed using a Cox proportional hazards regression model that included baseline use of antifibrotic therapy (antifibrotic group vs non-antifibrotic group), age, baseline forced vital capacity (FVC) percentage predicted, baseline diffusing capacity of the lungs for carbon monoxide (DLCO) percentage predicted (corrected for hemoglobin levels), and treatment group as covariates.||1.65|0.75|0.5896
72488513|NCT05321069|144505297|SUPERIORITY||Hazard Ratio (HR)|0.98||||0.9038|TWO_SIDED|95.0|0.7|1.36|||Regression, Cox|||Analysis was performed using a Cox proportional hazards regression model that included baseline use of antifibrotic therapy (antifibrotic group vs non-antifibrotic group), age, baseline forced vital capacity (FVC) percentage predicted, baseline diffusing capacity of the lungs for carbon monoxide (DLCO) percentage predicted (corrected for hemoglobin levels), and treatment group as covariates.||1.36|0.70|0.9038
72488514|NCT05321069|144505297|SUPERIORITY||Hazard Ratio (HR)|1.13||||0.4687|TWO_SIDED|95.0|0.82|1.56|||Regression, Cox|||Analysis was performed using a Cox proportional hazards regression model that included baseline use of antifibrotic therapy (antifibrotic group vs non-antifibrotic group), age, baseline forced vital capacity (FVC) percentage predicted, baseline diffusing capacity of the lungs for carbon monoxide (DLCO) percentage predicted (corrected for hemoglobin levels), and treatment group as covariates.||1.56|0.82|0.4687
72515820|NCT01763866|144562679|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-47.01|STANDARD_ERROR_OF_MEAN|2.75|<|0.001|TWO_SIDED|95.0|-52.46|-41.57||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-41.57|-52.46|<0.001
72515821|NCT01763866|144562679|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-40.59|STANDARD_ERROR_OF_MEAN|2.43|<|0.001|TWO_SIDED|95.0|-45.38|-35.79||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-35.79|-45.38|<0.001
72515822|NCT01763866|144562679|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-40.33|STANDARD_ERROR_OF_MEAN|2.87|<|0.001|TWO_SIDED|95.0|-46.0|-34.66||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-34.66|-46.00|<0.001
72403996|NCT03200899|144314470|SUPERIORITY|||||||0.297|||||||ANCOVA|||||||0.297
72403997|NCT03200899|144314471|SUPERIORITY|||||||0.293|||||||ANCOVA|||||||0.293
72403998|NCT03200899|144314472|SUPERIORITY|||||||0.045|||||||ANCOVA|||||||0.045
72403999|NCT04646499|144314475|SUPERIORITY|||||||0.34|||||||Sign test|||||||0.34
72404000|NCT04646499|144314476|SUPERIORITY|||||||0.024|||||||Sign test|||||||0.024
72568509|NCT00688376|144668411|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.7||||0.3155|TWO_SIDED|95.0|-1.63|4.99|||ANCOVA|||Metacognition Index Analysis. P-values, LS mean, and 95% confidence intervals were obtained from ANCOVA model with treatment group as a factor and baseline value as covariate.||4.99|-1.63|0.3155
72404001|NCT04646499|144314477|SUPERIORITY|||||||0.083|||||||Sign test|||||||0.083
72488515|NCT05321069|144505298|SUPERIORITY||Hazard Ratio (HR)|0.96||||0.7695|TWO_SIDED|95.0|0.74|1.25|||Regression, Cox|||Analysis was performed using a Cox proportional hazards regression model that included baseline use of antifibrotic therapy (antifibrotic group vs non-antifibrotic group), age, baseline forced vital capacity (FVC) percentage predicted, baseline diffusing capacity of the lungs for carbon monoxide (DLCO) percentage predicted (corrected for hemoglobin levels), and treatment group as covariates.||1.25|0.74|0.7695
72515823|NCT01763866|144562679|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-47.05|STANDARD_ERROR_OF_MEAN|2.38|<|0.001|TWO_SIDED|95.0|-51.76|-42.35||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-42.35|-51.76|<0.001
72515824|NCT01763866|144562679|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-48.62|STANDARD_ERROR_OF_MEAN|2.86|<|0.001|TWO_SIDED|95.0|-54.27|-42.98||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit||||-42.98|-54.27|<0.001
72515825|NCT01763866|144562680|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-46.83|STANDARD_ERROR_OF_MEAN|2.48|<|0.001|TWO_SIDED|95.0|-51.73|-41.94||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-41.94|-51.73|<0.001
72515826|NCT01763866|144562680|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-42.86|STANDARD_ERROR_OF_MEAN|2.82|<|0.001|TWO_SIDED|95.0|-48.43|-37.3||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-37.30|-48.43|<0.001
72515827|NCT01763866|144562680|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-28.6|STANDARD_ERROR_OF_MEAN|2.51|<|0.001|TWO_SIDED|95.0|-33.56|-23.65||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-23.65|-33.56|<0.001
72515828|NCT01763866|144562680|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-30.22|STANDARD_ERROR_OF_MEAN|2.8|<|0.001|TWO_SIDED|95.0|-35.74|-24.7||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-24.70|-35.74|<0.001
72515829|NCT01763866|144562680|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-45.1|STANDARD_ERROR_OF_MEAN|3.33|<|0.001|TWO_SIDED|95.0|-51.66|-38.54||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-38.54|-51.66|<0.001
72515830|NCT01763866|144562680|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-42.43|STANDARD_ERROR_OF_MEAN|3.34|<|0.001|TWO_SIDED|95.0|-49.01|-35.85||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-35.85|-49.01|<0.001
72515831|NCT01763866|144562680|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-30.26|STANDARD_ERROR_OF_MEAN|3.26|<|0.001|TWO_SIDED|95.0|-36.68|-23.84||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-23.84|-36.68|<0.001
72404002|NCT04646499|144314478|SUPERIORITY|||||||0.049|||||||Sign test|||||||0.049
72515832|NCT01763866|144562680|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-25.19|STANDARD_ERROR_OF_MEAN|3.35|<|0.001|TWO_SIDED|95.0|-31.79|-18.59||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-18.59|-31.79|<0.001
72515833|NCT01763866|144562680|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-43.25|STANDARD_ERROR_OF_MEAN|2.79|<|0.001|TWO_SIDED|95.0|-48.77|-37.74||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-37.74|-48.77|<0.001
72515834|NCT01763866|144562680|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-45.33|STANDARD_ERROR_OF_MEAN|2.89|<|0.001|TWO_SIDED|95.0|-51.04|-39.61||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-39.61|-51.04|<0.001
72515835|NCT01763866|144562680|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-41.13|STANDARD_ERROR_OF_MEAN|2.79|<|0.001|TWO_SIDED|95.0|-46.65|-35.61||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-35.61|-46.65|<0.001
72515836|NCT01763866|144562680|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-34.99|STANDARD_ERROR_OF_MEAN|3.41|<|0.001|TWO_SIDED|95.0|-41.72|-28.25||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-28.25|-41.72|<0.001
72404003|NCT04646499|144314479|SUPERIORITY|||||||0.31|||||||Sign test|||||||0.31
72404004|NCT01921829|144314553|SUPERIORITY|||||||0.05|||||||t-test, 2 sided|||||||0.05
72404005|NCT01921829|144314554|SUPERIORITY|||||||0.29|||||||t-test, 2 sided|||||||0.29
72404006|NCT01921829|144314556|SUPERIORITY||||||>|0.95|||||||Fisher Exact|||||||>0.95
72488516|NCT05321069|144505298|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.2068|TWO_SIDED|95.0|0.64|1.1|||Regression, Cox|||Analysis was performed using a Cox proportional hazards regression model that included baseline use of antifibrotic therapy (antifibrotic group vs non-antifibrotic group), age, baseline forced vital capacity (FVC) percentage predicted, baseline diffusing capacity of the lungs for carbon monoxide (DLCO) percentage predicted (corrected for hemoglobin levels), and treatment group as covariates.||1.10|0.64|0.2068
72488517|NCT05321069|144505299|SUPERIORITY||Hazard Ratio (HR)|0.98||||0.9251|TWO_SIDED|95.0|0.69|1.41|||Regression, Cox|||Analysis was performed using a Cox proportional hazards regression model that included baseline use of antifibrotic therapy (antifibrotic group vs non-antifibrotic group), age, baseline forced vital capacity (FVC) percentage predicted, baseline diffusing capacity of the lungs for carbon monoxide (DLCO) percentage predicted (corrected for hemoglobin levels), and treatment group as covariates.||1.41|0.69|0.9251
72488518|NCT05321069|144505299|SUPERIORITY||Hazard Ratio (HR)|0.88||||0.4988|TWO_SIDED|95.0|0.62|1.26|||Regression, Cox|||Analysis was performed using a Cox proportional hazards regression model that included baseline use of antifibrotic therapy (antifibrotic group vs non-antifibrotic group), age, baseline forced vital capacity (FVC) percentage predicted, baseline diffusing capacity of the lungs for carbon monoxide (DLCO) percentage predicted (corrected for hemoglobin levels), and treatment group as covariates.||1.26|0.62|0.4988
72488519|NCT05321069|144505300|SUPERIORITY||Hazard Ratio (HR)|1.03||||0.9084|TWO_SIDED|95.0|0.6|1.76|||Regression, Cox|||Analysis was performed using a Cox proportional hazards regression model that included baseline use of antifibrotic therapy (antifibrotic group vs non-antifibrotic group), age, baseline forced vital capacity (FVC) percentage predicted, baseline diffusing capacity of the lungs for carbon monoxide (DLCO) percentage predicted (corrected for hemoglobin levels), and treatment group as covariates.||1.76|0.60|0.9084
72488520|NCT05321069|144505300|SUPERIORITY||Hazard Ratio (HR)|0.81||||0.4682|TWO_SIDED|95.0|0.46|1.43|||Regression, Cox|||Analysis was performed using a Cox proportional hazards regression model that included baseline use of antifibrotic therapy (antifibrotic group vs non-antifibrotic group), age, baseline forced vital capacity (FVC) percentage predicted, baseline diffusing capacity of the lungs for carbon monoxide (DLCO) percentage predicted (corrected for hemoglobin levels), and treatment group as covariates.||1.43|0.46|0.4682
72488521|NCT05321069|144505301|SUPERIORITY||Mean Difference (Net)|-1.0||||0.3697|TWO_SIDED|95.0|-3.2|1.19|||Mixed Models Analysis||The adjusted mean difference represents the model-estimated difference in symptom change (L-PF Dyspnea score) between the Nera 9mg BID group and the Placebo group at Week 52.|The analysis used a Mixed Model for Repeated Measures (MMRM) with fixed categorical effects for treatment group and baseline antifibrotic therapy at each visit, and fixed continuous effects of baseline Living with Pulmonary Fibrosis (L-PF) Dyspnea domain score. An unstructured covariance structure accounted for within-patient correlations. Baseline antifibrotic use, as recorded in the concomitant medication case report form (CRF), was included as a covariate.||1.19|-3.20|0.3697
72488522|NCT05321069|144505301|SUPERIORITY||Mean Difference (Net)|-0.63||||0.5734|TWO_SIDED|95.0|-2.83|1.57|||Mixed Models Analysis||The adjusted mean difference represents the model-estimated difference in symptom change (L-PF Dyspnea score) between the Nera 18mg BID group and the Placebo group at Week 52.|The analysis used a Mixed Model for Repeated Measures (MMRM) with fixed categorical effects for treatment group and baseline antifibrotic therapy at each visit, and fixed continuous effects of baseline Living with Pulmonary Fibrosis (L-PF) Dyspnea domain score. An unstructured covariance structure accounted for within-patient correlations. Baseline antifibrotic use, as recorded in the concomitant medication case report form (CRF), was included as a covariate.||1.57|-2.83|0.5734
72488523|NCT05321069|144505302|SUPERIORITY||Mean Difference (Net)|-0.1||||0.9442|TWO_SIDED|95.0|-2.98|2.77|||Mixed Models Analysis||The adjusted mean difference represents the model-estimated difference in symptom change (L-PF Cough score) between the Nera 9 mg BID group and the Placebo group at Week 52.|The analysis was based on a Mixed Model for Repeated Measures (MMRM), which included fixed categorical effects for treatment group at each visit, baseline use of antifibrotic therapy at each visit, and fixed continuous effects of the baseline Living with Pulmonary Fibrosis (L-PF) Cough domain score at each visit. An unstructured covariance structure modeled repeated measures. Baseline antifibrotic use, recorded in the concomitant medication case report form (CRF), was included as a covariate.||2.77|-2.98|0.9442
72515837|NCT01763866|144562680|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-47.04|STANDARD_ERROR_OF_MEAN|2.43|<|0.001|TWO_SIDED|95.0|-51.83|-42.25||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-42.25|-51.83|<0.001
72515838|NCT01763866|144562680|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-44.6|STANDARD_ERROR_OF_MEAN|3.07|<|0.001|TWO_SIDED|95.0|-50.67|-38.54||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit||||-38.54|-50.67|<0.001
72568510|NCT00688376|144668411|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.2||||0.9075|TWO_SIDED|95.0|-3.55|3.16|||ANCOVA|||Working Memory Scale Analysis. P-values, LS mean, and 95% confidence intervals were obtained from ANCOVA model with treatment group as a factor and baseline value as covariate.||3.16|-3.55|0.9075
72568511|NCT02792959|144668463|NON_INFERIORITY|alpha=5%|Mean Difference (Net)|0.273||||0.602|TWO_SIDED||||||Kruskal-Wallis|||||||0.602
72404007|NCT01921829|144314557|SUPERIORITY|||||||0.58|||||||Fisher Exact|||||||0.58
72404008|NCT01921829|144314558|SUPERIORITY|||||||0.86|||||||t-test, 2 sided|||||||0.86
72404009|NCT01921829|144314559|SUPERIORITY|||||||0.4|||||||t-test, 2 sided|||||||0.40
72404010|NCT01921829|144314560|SUPERIORITY||||||>|0.95|||||||Fisher Exact|||||||>0.95
72404011|NCT01921829|144314561|SUPERIORITY|||||||0.08|||||||t-test, 2 sided|||||||0.08
72404012|NCT01921829|144314562|SUPERIORITY||||||>|0.95|||||||t-test, 2 sided|||||||>0.95
72404013|NCT01921829|144314563|SUPERIORITY|||||||0.52|||||||t-test, 2 sided|||||||0.52
72404014|NCT01921829|144314564|SUPERIORITY||||||>|0.95|||||||t-test, 2 sided|||||||>0.95
72404015|NCT01921829|144314565|SUPERIORITY||||||>|0.95|||||||t-test, 2 sided|||||||>0.95
72488524|NCT05321069|144505302|SUPERIORITY||Mean Difference (Net)|-0.59||||0.6862|TWO_SIDED|95.0|-3.47|2.28|||Mixed Models Analysis||The adjusted mean difference represents the model-estimated difference in symptom change (L-PF Cough score) between the Nera 18 mg BID group and the Placebo group at Week 52.|The analysis was based on a Mixed Model for Repeated Measures (MMRM), which included fixed categorical effects for treatment group at each visit, baseline use of antifibrotic therapy at each visit, and fixed continuous effects of the baseline Living with Pulmonary Fibrosis (L-PF) Cough domain score at each visit. An unstructured covariance structure modeled repeated measures. Baseline antifibrotic use, recorded in the concomitant medication case report form (CRF), was included as a covariate.||2.28|-3.47|0.6862
72488525|NCT05321069|144505303|SUPERIORITY||Mean Difference (Net)|0.19||||0.8759|TWO_SIDED|95.0|-2.25|2.63|||Mixed Models Analysis||The adjusted mean difference represents the model-estimated difference in symptom change (L-PF Fatigue score) between the Nera 9 mg BID group and the Placebo group at Week 52.|The analysis was based on a Mixed Model for Repeated Measures (MMRM), which included fixed categorical effects for treatment group at each visit, baseline use of antifibrotic therapy at each visit, and fixed continuous effects of the baseline Living with Pulmonary Fibrosis (L-PF) Fatigue domain score at each visit. An unstructured covariance structure modeled repeated measures. Baseline antifibrotic use, recorded in the concomitant medication case report form (CRF), was included as a covariate.||2.63|-2.25|0.8759
72515839|NCT01763866|144562681|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-59.97|STANDARD_ERROR_OF_MEAN|2.51|<|0.001|TWO_SIDED|95.0|-64.91|-55.03||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-55.03|-64.91|<0.001
72515840|NCT01763866|144562681|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-54.11|STANDARD_ERROR_OF_MEAN|2.77|<|0.001|TWO_SIDED|95.0|-59.57|-48.64||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-48.64|-59.57|<0.001
72515841|NCT01763866|144562681|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-37.79|STANDARD_ERROR_OF_MEAN|2.54|<|0.001|TWO_SIDED|95.0|-42.8|-32.77||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-32.77|-42.80|<0.001
72515842|NCT01763866|144562681|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-41.86|STANDARD_ERROR_OF_MEAN|2.78|<|0.001|TWO_SIDED|95.0|-47.34|-36.67||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-36.67|-47.34|<0.001
72515843|NCT01763866|144562681|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-56.9|STANDARD_ERROR_OF_MEAN|3.71|<|0.001|TWO_SIDED|95.0|-64.22|-49.59||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-49.59|-64.22|<0.001
72568512|NCT02792959|144668464|SUPERIORITY|alpha=5%|Mean Difference (Net)|3.361||||0.067|TWO_SIDED||||||Kruskal-Wallis|||||||0.067
72568513|NCT02792959|144668465|SUPERIORITY|alpha=5%|Mean Difference (Net)|4.0||||0.036|TWO_SIDED||||||Kruskal-Wallis|||||||0.036
72568514|NCT02792959|144668466|SUPERIORITY|alpha=5%|Mean Difference (Net)|1.091||||0.296|TWO_SIDED||||||Kruskal-Wallis|||||||0.296
72568515|NCT02792959|144668467|SUPERIORITY|alpha=5%|Mean Difference (Net)|0.068||||0.794|TWO_SIDED||||||Kruskal-Wallis|||||||0.794
72568516|NCT02792959|144668468|SUPERIORITY|alpha=5%|Mean Difference (Net)|3.361||||0.067|TWO_SIDED||||||Kruskal-Wallis|||||||0.067
72568517|NCT02792959|144668469|SUPERIORITY|alpha=5%|Mean Difference (Net)|1.0||||0.296|TWO_SIDED||||||Kruskal-Wallis|||||||0.296
72568518|NCT02792959|144668470|SUPERIORITY|alpha=5%|Mean Difference (Net)|4.39||||0.036|TWO_SIDED||||||Kruskal-Wallis|||||||0.036
72568519|NCT02792959|144668471|SUPERIORITY|alpha=5%|Mean Difference (Net)|0.068||||0.794|TWO_SIDED||||||Kruskal-Wallis|||||||0.794
72404016|NCT01921829|144314566|SUPERIORITY|||||||0.52|||||||t-test, 2 sided|||||||0.52
72404017|NCT01921829|144314567|SUPERIORITY|||||||0.17|||||||t-test, 2 sided|||||||0.17
72404018|NCT01921829|144314568|SUPERIORITY|||||||0.17|||||||t-test, 2 sided|||||||0.17
72404019|NCT01921829|144314569|SUPERIORITY|||||||0.4|||||||t-test, 2 sided|||||||0.40
72404020|NCT01921829|144314570|SUPERIORITY||||||>|0.95|||||||t-test, 2 sided|||||||>0.95
72404021|NCT01921829|144314571|SUPERIORITY|||||||0.55|||||||t-test, 2 sided|||||||0.55
72404022|NCT01921829|144314572|SUPERIORITY||||||>|0.95|||||||t-test, 2 sided|||||||>0.95
72404023|NCT01921829|144314573|SUPERIORITY||||||>|0.95|||||||Fisher Exact|||||||>0.95
72404024|NCT04476030|144314574|SUPERIORITY||LS Mean Difference|-1.9|STANDARD_ERROR_OF_MEAN|0.55||0.0004|TWO_SIDED|95.0|-3.0|-0.9|||MMRM||Model used was the MMRM with treatment, baseline HAMD-17 total score, antidepressant use (SSRI/SNRI), assessment time point, and time point-by-treatment interaction as fixed effects with unstructured covariance structure.|||-0.9|-3.0|0.0004
72404025|NCT04476030|144314575|SUPERIORITY||LS Mean Difference|-1.6|STANDARD_ERROR_OF_MEAN|0.56||0.0054|TWO_SIDED|95.0|-2.7|-0.5|||MMRM||Model used was the MMRM with treatment, baseline HAMD-17 total score, antidepressant use (SSRI/SNRI), assessment time point, and time point-by-treatment interaction as fixed effects with unstructured covariance structure.|||-0.5|-2.7|0.0054
72404026|NCT04476030|144314576|SUPERIORITY||LS Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.7||0.2477|TWO_SIDED|95.0|-2.2|0.6|||MMRM||Model used was the MMRM with treatment, baseline HAMD-17 total score, antidepressant use (SSRI/SNRI), assessment time point, and time point-by-treatment interaction as fixed effects with unstructured covariance structure.|Day 15||0.6|-2.2|0.2477
72515844|NCT01763866|144562681|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-61.99|STANDARD_ERROR_OF_MEAN|3.39|<|0.001|TWO_SIDED|95.0|-68.68|-55.29||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-55.29|-68.68|<0.001
72515845|NCT01763866|144562681|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-37.26|STANDARD_ERROR_OF_MEAN|3.66|<|0.001|TWO_SIDED|95.0|-44.48|-30.04||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-30.04|-44.48|<0.001
72515846|NCT01763866|144562681|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-43.29|STANDARD_ERROR_OF_MEAN|3.44|<|0.001|TWO_SIDED|95.0|-50.07|-36.51||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-36.51|-50.07|<0.001
72515847|NCT01763866|144562681|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-55.29|STANDARD_ERROR_OF_MEAN|2.78|<|0.001|TWO_SIDED|95.0|-60.79|-49.79||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-49.79|-60.79|<0.001
72515848|NCT01763866|144562681|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-59.24|STANDARD_ERROR_OF_MEAN|2.49|<|0.001|TWO_SIDED|95.0|-64.16|-54.32||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-54.32|-64.16|<0.001
72515849|NCT01763866|144562681|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-50.63|STANDARD_ERROR_OF_MEAN|3.13|<|0.001|TWO_SIDED|95.0|-56.82|-44.45||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-44.45|-56.82|<0.001
72515850|NCT01763866|144562681|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-56.78|STANDARD_ERROR_OF_MEAN|3.61|<|0.001|TWO_SIDED|95.0|-63.91|-49.64||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-49.64|-63.91|<0.001
72515851|NCT01763866|144562681|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-57.75|STANDARD_ERROR_OF_MEAN|2.41|<|0.001|TWO_SIDED|95.0|-62.51|-52.99||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-52.99|-62.51|<0.001
72515852|NCT01763866|144562681|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-56.06|STANDARD_ERROR_OF_MEAN|2.93|<|0.001|TWO_SIDED|95.0|-61.85|-50.27||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit||||-50.27|-61.85|<0.001
72515853|NCT01763866|144562682|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-60.29|STANDARD_ERROR_OF_MEAN|2.71|<|0.001|TWO_SIDED|95.0|-65.65|-54.94||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-54.94|-65.65|<0.001
72515854|NCT01763866|144562682|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-48.44|STANDARD_ERROR_OF_MEAN|2.94|<|0.001|TWO_SIDED|95.0|-54.23|-42.65||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-42.65|-54.23|<0.001
72515855|NCT01763866|144562682|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-39.66|STANDARD_ERROR_OF_MEAN|2.75|<|0.001|TWO_SIDED|95.0|-45.09|-34.23||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-34.23|-45.09|<0.001
72515856|NCT01763866|144562682|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-37.32|STANDARD_ERROR_OF_MEAN|2.94|<|0.001|TWO_SIDED|95.0|-43.12|-31.52||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-31.52|-43.12|<0.001
72515857|NCT01763866|144562682|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-57.77|STANDARD_ERROR_OF_MEAN|3.95|<|0.001|TWO_SIDED|95.0|-65.55|-49.99||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-49.99|-65.55|<0.001
72515858|NCT01763866|144562682|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-57.26|STANDARD_ERROR_OF_MEAN|3.88|<|0.001|TWO_SIDED|95.0|-64.91|-49.6||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-49.60|-64.91|<0.001
72568520|NCT02792959|144668472|SUPERIORITY|alpha=5%|Mean Difference (Net)|4.39||||0.036|TWO_SIDED||||||Kruskal-Wallis|||||||0.036
72488526|NCT05321069|144505303|SUPERIORITY||Mean Difference (Net)|0.43||||0.732|TWO_SIDED|95.0|-2.02|2.87|||Mixed Models Analysis||The adjusted mean difference represents the model-estimated difference in symptom change (L-PF Fatigue score) between the Nera 18 mg BID group and the Placebo group at Week 52.|The analysis was based on a Mixed Model for Repeated Measures (MMRM), which included fixed categorical effects for treatment group at each visit, baseline use of antifibrotic therapy at each visit, and fixed continuous effects of the baseline Living with Pulmonary Fibrosis (L-PF) Fatigue domain score at each visit. An unstructured covariance structure modeled repeated measures. Baseline antifibrotic use, recorded in the concomitant medication case report form (CRF), was included as a covariate.||2.87|-2.02|0.7320
72488527|NCT05321069|144505304|SUPERIORITY||Mean Difference (Net)|1.17||||0.028|TWO_SIDED|95.0|0.13|2.22|||Mixed Models Analysis||The adjusted mean difference represents the model-estimated difference in percent predicted Forced Vital Capacity between the Nera 9 mg BID group and the placebo group at Week 52.|"Analysis was based on a Mixed Model for Repeated Measures (MMRM), which included fixed, categorical effects of treatment, baseline use of antifibrotic therapy, and the fixed continuous effects of baseline forced vital capacity (FVC) percentage predicted at each visit. An unstructured covariance structure was used to model repeated measures within patients.~Baseline use of antifibrotic therapy, as recorded in the concomitant medication case report form (CRF) page, was included as a covariate."||2.22|0.13|0.0280
72488528|NCT05321069|144505304|SUPERIORITY||Mean Difference (Net)|1.73||||0.0013|TWO_SIDED|95.0|0.68|2.78|||Mixed Models Analysis||The adjusted mean difference represents the model-estimated difference in percent predicted Forced Vital Capacity between the Nera 18 mg BID group and the placebo group at Week 52.|"Analysis was based on a Mixed Model for Repeated Measures (MMRM), which included fixed, categorical effects of treatment, baseline use of antifibrotic therapy, and the fixed continuous effects of baseline forced vital capacity (FVC) percentage predicted at each visit. An unstructured covariance structure was used to model repeated measures within patients.~Baseline use of antifibrotic therapy, as recorded in the concomitant medication case report form (CRF) page, was included as a covariate."||2.78|0.68|0.0013
72488529|NCT05321069|144505305|SUPERIORITY||Mean Difference (Net)|2.49||||0.0042|TWO_SIDED|95.0|0.79|4.19|||Mixed Models Analysis||The adjusted mean difference represents the model-estimated difference in percent predicted DLCO between the Nera 9 mg BID group and the placebo group at Week 52.|"Based on a Mixed Model for Repeated Measures (MMRM), which included fixed, categorical effects of treatment, baseline use of antifibrotic therapy, and the fixed continuous effects of baseline diffusing capacity of the lungs for carbon monoxide (DLCO) percentage predicted at each visit. An unstructured covariance structure was used to model repeated measures within patients.~Baseline use of antifibrotic therapy, as recorded in the concomitant medication CRF page, was included as a covariate."||4.19|0.79|0.0042
72488530|NCT05321069|144505305|SUPERIORITY||Mean Difference (Net)|1.67||||0.053|TWO_SIDED|95.0|-0.02|3.37|||Mixed Models Analysis||The adjusted mean difference represents the model-estimated difference in percent predicted DLCO between the Nera 18 mg BID group and the placebo group at Week 52.|"Based on a Mixed Model for Repeated Measures (MMRM), which included fixed, categorical effects of treatment, baseline use of antifibrotic therapy, and the fixed continuous effects of baseline diffusing capacity of the lungs for carbon monoxide (DLCO) percentage predicted at each visit. An unstructured covariance structure was used to model repeated measures within patients.~Baseline use of antifibrotic therapy, as recorded in the concomitant medication CRF page, was included as a covariate."||3.37|-0.02|0.0530
72488531|NCT01538628|144505338|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0001|||||||Exact binomial test|testing the null hypothesis that the proportion for SpaceOAR is less than or equal to 0.70.||||||.0001
72488532|NCT02535715|144505359|SUPERIORITY|ANOVA Bonferroni adjustment|||||<|0.05|||||||ANOVA|||||||<0.05
72488533|NCT02933034|144505361|OTHER|||||||0.001|||||||t-test, 2 sided|||Comparison of infarct size using MEMRI versus DEMRI scan||||0.001
72488534|NCT03901105|144505398|OTHER||Risk Ratio (RR)|1.36||||0.0313|TWO_SIDED|95.0|1.028|1.785||A priori threshold was two-sided 0.05.|log linear model|Adjusted for treatment arm (lanabecestat 20 mg, 50 mg, or placebo), baseline age, years of education (categorical), and baseline CDR-SB score.|τAD++ scans represent the numerator for risk, and τAD+/τAD- scans represent the denominator|Scan results were grouped into τAD++ vs. non-τAD++ (τAD+ and τAD-) for the analysis||1.785|1.028|0.0313
72488535|NCT03901105|144505399|OTHER||Risk Ratio (RR)|1.35||||0.0833|TWO_SIDED|95.0|0.962|1.886||A priori threshold was two-sided 0.05. No adjustment for multiple comparisons.|log linear model|Adjusted for treatment arm (lanabecestat 20 mg, 50 mg, or placebo), baseline age, years of education (categorical), and baseline score.|τAD++ scans represent the numerator for risk, and τAD+/τAD- scans represent the denominator|Risk ratio for MMSE CMD. Scan results were grouped into τAD++ vs. non-τAD++ (τAD+ and τAD-) for the analysis||1.886|0.962|.0833
72488536|NCT03901105|144505399|OTHER||Risk Ratio (RR)|1.77||||0.0141|TWO_SIDED|95.0|1.122|2.796||A priori threshold was two-sided 0.05. No adjustment for multiple comparisons.|log linear model|Adjusted for treatment arm (lanabecestat 20 mg, 50 mg, or placebo), baseline age, years of education (categorical), and baseline score.|τAD++ scans represent the numerator for risk, and τAD+/τAD- scans represent the denominator|Risk ratio for ADAS-Cog11 CMD. Scan results were grouped into τAD++ vs. non-τAD++ (τAD+ and τAD-) for the analysis||2.796|1.122|.0141
72568521|NCT02792959|144668473|SUPERIORITY|alpha=5%|Mean Difference (Net)|0.273||||0.602|TWO_SIDED||||||Kruskal-Wallis|||||||0.602
72488537|NCT03901105|144505399|OTHER||Risk Ratio (RR)|1.32||||0.0639|TWO_SIDED|95.0|0.984|1.776||A priori threshold was two-sided 0.05. No adjustment for multiple comparisons.|log linear model|Adjusted for treatment arm (lanabecestat 20 mg, 50 mg, or placebo), baseline age, years of education (categorical), and baseline score.|τAD++ scans represent the numerator for risk, and τAD+/τAD- scans represent the denominator|Risk ratio for FAQ CMD. Scan results were grouped into τAD++ vs. non-τAD++ (τAD+ and τAD-) for the analysis||1.776|0.984|.0639
72568522|NCT02792959|144668474|SUPERIORITY|alpha=5%|Mean Difference (Net)|1.705||||0.192|TWO_SIDED||||||Kruskal-Wallis|||||||0.192
72568523|NCT04168190|144668493|OTHER|Estimated difference and CI are calculated based on the Miettinen \& Nurminen method|Difference in Percentage|-10.0|||||TWO_SIDED|95.0|-29.3|9.0|||||Phase 1: V116 0.5 mL minus Phase 1: Pneumovax™23|Injection site erythema||9.0|-29.3|
72488538|NCT03901105|144505399|OTHER||Risk Ratio (RR)|1.28||||0.2814|TWO_SIDED|95.0|0.815|2.02||A priori threshold was two-sided 0.05. No adjustment for multiple comparisons.|log linear model|Adjusted for treatment arm (lanabecestat 20 mg, 50 mg, or placebo), baseline age, years of education (categorical), and baseline score.|τAD++ scans represent the numerator for risk, and τAD+/τAD- scans represent the denominator|Risk ratio for CDR Global CMD. Scan results were grouped into τAD++ vs. non-τAD++ (τAD+ and τAD-) for the analysis||2.020|0.815|.2814
72488539|NCT03901105|144505400|OTHER|||||||0.0305||||||A priori threshold was two-sided 0.05. No adjustment for multiple comparisons.|Mixed Models Analysis|Adjusted for baseline clinical score, age, years of education (categorical), and treatment arm (lanabecestat - 20mg or 50mg - or placebo).||MMRM testing the difference between CDR-SB least squares mean changes of tAD++ and Non-tAD++ (tAD+ and tAD-). The unstructured covariance structure (UN) was used.||||.0305
72488540|NCT03901105|144505400|OTHER||||||<|0.0001||||||A priori threshold was two-sided 0.05. No adjustment for multiple comparisons.|Mixed Models Analysis|Adjusted for baseline clinical score, age, years of education (categorical), and treatment arm (lanabecestat - 20mg or 50mg - or placebo).||MMRM testing the difference between MMSE least squares mean changes of tAD++ and Non-tAD++ (tAD+ and tAD-). The unstructured covariance structure (UN) was used.||||<0.0001
72488541|NCT03901105|144505400|OTHER|||||||0.0006||||||A priori threshold was two-sided 0.05. No adjustment for multiple comparisons.|Mixed Models Analysis|Adjusted for baseline clinical score, age, years of education (categorical), and treatment arm (lanabecestat - 20mg or 50mg - or placebo).||MMRM testing the difference between ADAS-Cog11 least squares mean changes of tAD++ and Non-tAD++ (tAD+ and tAD-). The unstructured covariance structure (UN) was used.||||0.0006
72488542|NCT03901105|144505400|OTHER|||||||0.0097||||||A priori threshold was two-sided 0.05. No adjustment for multiple comparisons.|Mixed Models Analysis|Adjusted for baseline clinical score, age, years of education (categorical), and treatment arm (lanabecestat - 20mg or 50mg - or placebo).||MMRM testing the difference between FAQ least squares mean changes of tAD++ and Non-tAD++ (tAD+ and tAD-). The unstructured covariance structure (UN) was used.||||0.0097
72488543|NCT01648790|144505429|SUPERIORITY_OR_OTHER||Ratio of Geometric Least Squares Means|0.983|||||TWO_SIDED|90.0|0.819|1.18|||||Least Squares (LS) means were determined by mixed-effect linear models with treatment, period, sequence as fixed effects, and participants nested within sequence as random effect.|||1.18|0.819|
72488544|NCT01648790|144505430|SUPERIORITY_OR_OTHER||Ratio of Geometric Least Squares Means|0.987|||||TWO_SIDED|90.0|0.918|1.06|||||LS means were determined by mixed-effect linear models with treatment, period, sequence as fixed effects, and participants nested within sequence as random effect.|||1.06|0.918|
72488545|NCT01648790|144505431|SUPERIORITY_OR_OTHER||Ratio of Geometric Least Squares Means|0.28|||||TWO_SIDED|90.0|0.233|0.335|||||LS means were determined by mixed-effect linear models with treatment, period, sequence as fixed effects, and participants nested within sequence as random effect.|||0.335|0.233|
72488546|NCT01648790|144505432|SUPERIORITY_OR_OTHER||Ratio of Geometric Least Squares Means|0.779|||||TWO_SIDED|90.0|0.724|0.837|||||LS means were determined by mixed-effect linear models with treatment, period, sequence as fixed effects, and participants nested within sequence as random effect.|||0.837|0.724|
72488547|NCT01486927|144505438|SUPERIORITY_OR_OTHER||Rate ratio|0.08|||<|0.0001|TWO_SIDED|95.0|0.07|0.1|||Poisson, regression|||A test of the null hypothesis of no difference on AsBR between the 2 comparison groups was based on the Poisson Regression method. The corresponding prophylaxis/on-demand ratio with 95% confidence interval (CI) was calculated.||0.10|0.07|< 0.0001
72515859|NCT01763866|144562682|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-39.9|STANDARD_ERROR_OF_MEAN|3.87|<|0.001|TWO_SIDED|95.0|-47.53|-32.26||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-32.26|-47.53|<0.001
72515860|NCT01763866|144562682|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-38.57|STANDARD_ERROR_OF_MEAN|3.9|<|0.001|TWO_SIDED|95.0|-46.26|-30.88||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-30.88|-46.26|<0.001
72568524|NCT04168190|144668493|OTHER|Estimated difference and CI are calculated based on the Miettinen \& Nurminen method|Difference in Percentage|3.3|||||TWO_SIDED|95.0|-18.1|24.6|||||Phase 1: V116 1.0 mL minus Phase 1: Pneumovax™23|Injection site erythema||24.6|-18.1|
72568525|NCT04168190|144668493|OTHER|Estimated difference and CI are calculated based on the Miettinen \& Nurminen method|Difference in Percentage|16.7|||||TWO_SIDED|95.0|-7.7|39.3|||||Phase 1: V116 0.5 mL minus Phase 1: Pneumovax™23|Injection site pain||39.3|-7.7|
72568526|NCT04168190|144668493|OTHER|Estimated difference and CI are calculated based on the Miettinen \& Nurminen method|Difference in Percentage|20.0|||||TWO_SIDED|95.0|-4.1|42.1|||||Phase 1: V116 1.0 mL minus Phase 1: Pneumovax™23|Injection site pain||42.1|-4.1|
72488548|NCT00365456|144505458|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.012|STANDARD_ERROR_OF_MEAN|1.0045||0.01|TWO_SIDED|95.0|1.003|1.021||No multiplicity correction of the significance level was performed as only one primary endpoint was planned.|ANCOVA|Estimation allowing for unequal variance in the two treatment groups and robust estimates for the standard errors were obtained.||An analysis of covariance (ANCOVA) model was used including treatment group, stratum and pooled centre as fixed effects and log (BMD at Baseline III (month 24)) as a covariate (log-normally distributed data assumed). Least square mean change from baseline III (month 24), 95% confidence interval and p-value for the treatment effect (PTH (1-84) vs. Risedronate) was calculated. Superiority was claimed if lower limit of the interval was above 1. Results were back-transformed from the log scale.||1.021|1.003|0.010
72515861|NCT01763866|144562682|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-54.41|STANDARD_ERROR_OF_MEAN|2.83|<|0.001|TWO_SIDED|95.0|-59.99|-48.82||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-48.82|-59.99|<0.001
72515862|NCT01763866|144562682|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-56.13|STANDARD_ERROR_OF_MEAN|2.76|<|0.001|TWO_SIDED|95.0|-61.58|-50.68||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-50.68|-61.58|<0.001
72488549|NCT01476475|144505461|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority of insulin glargine/lixisenatide FRC versus insulin glargine was tested first, at alpha level of 0.025 (1-sided) and a non-inferiority margin of 0.4% HbA1c. If non-inferiority was established, then a test of superiority of insulin glargine/lixisenatide FRC over insulin glargine would be performed, at alpha level of 0.05 (2-sided). The non-inferiority was assessed using upper bound of 2-sided 95% confidence interval (CI) at ≤0.4%.|Least square (LS) mean difference|-0.17|STANDARD_ERROR_OF_MEAN|0.07|||TWO_SIDED|95.0|-0.312|-0.037|||ANCOVA||Insulin glargine/Lixisenatide FRC vs Insulin glargine|Analysis was performed using analysis of covariance (ANCOVA) model with treatment groups, randomization strata of screening HbA1c (\<8.0, ≥8.0%), randomization strata of screening BMI (\<30 kg/m\^2, ≥30 kg/m\^2), and country as fixed effects and baseline HbA1c value as covariates. A step-down testing procedure described by Hochberg and Tamhane was used to control type-1 error.||-0.037|-0.312|
72515863|NCT01763866|144562682|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-49.17|STANDARD_ERROR_OF_MEAN|3.36|<|0.001|TWO_SIDED|95.0|-55.8|-42.53||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-42.53|-55.80|<0.001
72515864|NCT01763866|144562682|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-48.81|STANDARD_ERROR_OF_MEAN|4.25|<|0.001|TWO_SIDED|95.0|-57.21|-40.4||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-40.40|-57.21|<0.001
72515865|NCT01763866|144562682|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-57.73|STANDARD_ERROR_OF_MEAN|2.57|<|0.001|TWO_SIDED|95.0|-62.82|-52.65||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-52.65|-62.82|<0.001
72515866|NCT01763866|144562682|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-52.04|STANDARD_ERROR_OF_MEAN|3.07|<|0.001|TWO_SIDED|95.0|-58.1|-45.98||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit||||-45.98|-58.10|<0.001
72515867|NCT01763866|144562683|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|82.4|||<|0.001|TWO_SIDED|95.0|70.2|88.5||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on Cochran-Mantel Haenszel test stratified by the stratification factors (entry statin therapy and simvastatin contraindicated therapy usage)||||88.5|70.2|<0.001
72515868|NCT01763866|144562683|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|80.3|||<|0.001|TWO_SIDED|95.0|67.9|86.8||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on Cochran-Mantel Haenszel test stratified by the stratification factors (entry statin therapy and simvastatin contraindicated therapy usage).||||86.8|67.9|<0.001
72515869|NCT01763866|144562683|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|68.1|||<|0.001|TWO_SIDED|95.0|53.1|78.1||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on Cochran-Mantel Haenszel test stratified by the stratification factors (entry statin therapy and simvastatin contraindicated therapy usage).||||78.1|53.1|<0.001
72515870|NCT01763866|144562683|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|69.2|||<|0.001|TWO_SIDED|95.0|54.8|78.5||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on Cochran-Mantel Haenszel test stratified by the stratification factors (entry statin therapy and simvastatin contraindicated therapy usage)||||78.5|54.8|<0.001
72515871|NCT01763866|144562683|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|80.7|||<|0.001|TWO_SIDED|95.0|67.3|88.3||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on Cochran-Mantel Haenszel test stratified by the stratification factors (entry statin therapy and simvastatin contraindicated therapy usage).||||88.3|67.3|<0.001
72515872|NCT01763866|144562683|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|83.3|||<|0.001|TWO_SIDED|95.0|70.7|89.6||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on Cochran-Mantel Haenszel test stratified by the stratification factors (entry statin therapy and simvastatin contraindicated therapy usage)||||89.6|70.7|<0.001
72515873|NCT01763866|144562683|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|43.5|||<|0.001|TWO_SIDED|95.0|29.5|56.7||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on Cochran-Mantel Haenszel test stratified by the stratification factors (entry statin therapy and simvastatin contraindicated therapy usage).||||56.7|29.5|<0.001
72515874|NCT01763866|144562683|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|30.3|||<|0.001|TWO_SIDED|95.0|16.7|44.2||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on Cochran-Mantel Haenszel test stratified by the stratification factors (entry statin therapy and simvastatin contraindicated therapy usage).||||44.2|16.7|<0.001
72515875|NCT01763866|144562683|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|81.7|||<|0.001|TWO_SIDED|95.0|69.5|88.0||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on Cochran-Mantel Haenszel test stratified by the stratification factors (entry statin therapy and simvastatin contraindicated therapy usage).||||88.0|69.5|<0.001
72515876|NCT01763866|144562683|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|84.6|||<|0.001|TWO_SIDED|95.0|73.1|90.2||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on Cochran-Mantel Haenszel test stratified by the stratification factors (entry statin therapy and simvastatin contraindicated therapy usage).||||90.2|73.1|<0.001
72568527|NCT04168190|144668493|OTHER|Estimated difference and CI are calculated based on the Miettinen \& Nurminen method|Difference in Percentage|6.7|||||TWO_SIDED|95.0|-13.2|26.5|||||Phase 1: V116 0.5 mL minus Phase 1: Pneumovax™23|Injection site swelling||26.5|-13.2|
72488550|NCT01476475|144505461|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.07||0.013|TWO_SIDED|95.0|-0.312|-0.037||Threshold for significance at 0.05 level.|ANCOVA||Insulin glargine/Lixisenatide FRC vs Insulin glargine|Analysis was performed using ANCOVA model with treatment groups, randomization strata of screening HbA1c (\<8.0, ≥8.0%), randomization strata of screening BMI (\<30 kg/m\^2, ≥30 kg/m\^2), and country as fixed effects and baseline HbA1c value as covariates. If non-inferiority was established, then a test of superiority of insulin glargine/lixisenatide FRC over insulin glargine would be performed, at alpha level of 0.05 (2-sided).||-0.037|-0.312|0.0130
72488551|NCT01476475|144505462|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.17|STANDARD_ERROR_OF_MEAN|0.337|<|0.0001|TWO_SIDED|95.0|-3.832|-2.504||Threshold for significance at 0.05 level.|ANCOVA||Insulin glargine/Lixisenatide FRC vs Insulin glargine|Analysis was performed using ANCOVA with treatment groups,randomization strata of screening HbA1c(\<8.0, ≥8.0%)\& screening BMI(\<30 kg/m\^2, ≥30 kg/m\^2),country as fixed effects and baseline 2-hour PPG value as covariates.A step-down testing procedure used to control type-1 error.If non-inferiority demonstrated for primary endpoint,superiority testing on secondary endpoints was performed sequentially in order endpoints are reported(continued only if previous endpoint was statistically significant).||-2.504|-3.832|<0.0001
72488552|NCT01476475|144505463|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.24|STANDARD_ERROR_OF_MEAN|0.331|<|0.0001|TWO_SIDED|95.0|-3.895|-2.592||Threshold for significance at 0.05 level.|ANCOVA||Insulin glargine/Lixisenatide FRC vs Insulin glargine|Testing according to the step-down testing procedure (continued only if previous endpoint was statistically significant). Analysis was performed using ANCOVA model with treatment groups, randomization strata of screening HbA1c (\<8.0, ≥8.0%), randomization strata of screening BMI (\<30 kg/m\^2, ≥30 kg/m\^2), and country as fixed effects and baseline 2-hour plasma glucose excursion value as covariates.||-2.592|-3.895|<0.0001
72488553|NCT01476475|144505464|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.125||0.0154|TWO_SIDED|95.0|-0.55|-0.058||Threshold for significance at 0.05 level.|ANCOVA||Insulin glargine/Lixisenatide FRC vs Insulin glargine|Testing according to the step-down testing procedure (continued only if previous endpoint was statistically significant). Analysis was performed using ANCOVA model with treatment groups, randomization strata of screening HbA1c (\<8.0, ≥8.0%), randomization strata of screening BMI (\<30 kg/m\^2, ≥30 kg/m\^2), and country as fixed effects and baseline average 7-point SMPG value as covariates.||-0.058|-0.550|0.0154
72488554|NCT01476475|144505465|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.44|STANDARD_ERROR_OF_MEAN|0.34|<|0.0001|TWO_SIDED|95.0|-2.11|-0.773||Threshold for significance at 0.05 level.|ANCOVA||Insulin glargine/Lixisenatide FRC vs Insulin glargine|Testing according to the step-down testing procedure (continued only if previous endpoint was statistically significant). Analysis was performed using ANCOVA model with treatment groups, randomization strata of screening HbA1c (\<8.0, ≥8.0%), randomization strata of screening BMI (\<30 kg/m\^2, ≥30 kg/m\^2), and country as fixed effects and baseline body weight value as covariates.||-0.773|-2.110|<0.0001
72488555|NCT01476475|144505466|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.24|STANDARD_ERROR_OF_MEAN|1.704||0.0583|TWO_SIDED|95.0|-6.592|0.114||Threshold for significance at 0.05 level.|ANCOVA||Insulin glargine/Lixisenatide FRC vs Insulin glargine|Testing according to the step-down testing procedure (continued only if previous endpoint was statistically significant). Analysis was performed using ANCOVA model with treatment groups, randomization strata of screening HbA1c (\<8.0, ≥8.0%), randomization strata of screening BMI (\<30 kg/m\^2, ≥30 kg/m\^2), and country as fixed effects.||0.114|-6.592|0.0583
72488556|NCT01278745|144505475|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0019|||||||ANCOVA|Adjusted for baseline PAV||||||0.0019
72488557|NCT01265615|144505488|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
72488558|NCT01265615|144505489|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
72488559|NCT01265615|144505490|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
72488560|NCT01265615|144505491|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
72488561|NCT01265615|144505492|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
72488562|NCT01265615|144505493|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
72488563|NCT01265615|144505494|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
72488564|NCT01265615|144505495|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
72488565|NCT01265615|144505496|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
72488566|NCT01265615|144505497|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
72488567|NCT01977599|144505524|OTHER|Chi Square|||||<|0.001|||||||Chi-squared|||||||<0.001
72488568|NCT02375724|144505555|SUPERIORITY_OR_OTHER||Least squares mean difference|-1.02||||0.0306|TWO_SIDED|95.0|-1.94|-0.1|||Mixed Models Analysis|Baseline and age as covariates; treatment group, sex, visit, smoking-status and treatment group-by-visit interaction as fixed effect factors||||-0.10|-1.94|0.0306
72488569|NCT02375724|144505556|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.22||||0.0793|TWO_SIDED|95.0|-0.46|0.03|||Mixed Models Analysis|Baseline and age as covariates; treatment group, sex, visit, smoking-status and treatment group-by-visit interaction as fixed effect factors||||0.03|-0.46|0.0793
72488570|NCT02375724|144505557|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.06||||0.844|TWO_SIDED|95.0|-0.64|0.52|||Mixed Models Analysis|Baseline and age as covariates; treatment group, sex, visit, smoking-status and treatment group-by-visit interaction as fixed effect factors||||0.52|-0.64|0.844
72488571|NCT02684604|144505558|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
72488572|NCT01197521|144505559|SUPERIORITY_OR_OTHER||Weighted difference in proportions|0.15|||<|0.001|TWO_SIDED|95.0|0.08|0.22||Week 24|Mantel Haenszel|Treatment difference in proportion of responders with a Mantel Haenszel approach stratified by pooled country.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||0.22|0.08|<0.001
72515877|NCT01763866|144562683|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|54.6|||<|0.001|TWO_SIDED|95.0|39.8|66.9||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on Cochran-Mantel Haenszel test stratified by the stratification factors (entry statin therapy and simvastatin contraindicated therapy usage).||||66.9|39.8|<0.001
72404027|NCT04476030|144314576|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.79||0.9248|TWO_SIDED|95.0|-1.6|1.5|||MMRM||Model used was the MMRM with treatment, baseline HAMD-17 total score, antidepressant use (SSRI/SNRI), assessment time point, and time point-by-treatment interaction as fixed effects with unstructured covariance structure.|Day 42||1.5|-1.6|0.9248
72404028|NCT04476030|144314577|SUPERIORITY||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.65||0.4458|TWO_SIDED|95.0|-1.8|0.8|||MMRM||Model used was the MMRM with treatment, baseline HAMD-17 total score, antidepressant use (SSRI/SNRI), assessment time point, and time point-by-treatment interaction as fixed effects with unstructured covariance structure.|||0.8|-1.8|0.4458
72488573|NCT01197521|144505559|SUPERIORITY_OR_OTHER||Weighted difference in proportions|0.1||||0.006|TWO_SIDED|95.0|0.03|0.18||Week 24|Mantel Haenszel|Treatment difference in proportion of responders with a Mantel Haenszel approach stratified by pooled country.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||0.18|0.03|0.006
72488574|NCT01197521|144505560|SUPERIORITY_OR_OTHER|||||||0.252||||||Week 24|Cochran-Mantel-Haenszel|The residuals from the ANCOVA are analysed using a Cochran-Mantel-Haenszel approach, adjusting for the effects of pooled country.||This analysis is performed using an ANCOVA model on the ranks of the change from baseline, by pooled country, including a term for the ranks of the baseline score as a covariate.||||0.252
72488575|NCT01197521|144505560|SUPERIORITY_OR_OTHER|||||||0.17||||||Week 24|Cochran-Mantel-Haenszel|The residuals from the ANCOVA are analysed using a Cochran-Mantel-Haenszel approach, adjusting for the effects of pooled country.||This analysis is performed using an ANCOVA model on the ranks of the change from baseline, by pooled country, including a term for the ranks of the baseline score as a covariate.||||0.170
72488576|NCT01197521|144505561|SUPERIORITY_OR_OTHER||Weighted difference in proportion|0.13|||<|0.001|TWO_SIDED|95.0|0.1|0.17||Nominal p-values presented. Formal statistical testing could not be carried out due to the predefined multiplicity procedure (as the primary variable comparisons were non-significant).|Mantel Haenszel|95% confidence intervals and p-values are calculated using a Mantel Haenszel approach stratified by pooled country.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||0.17|0.10|<0.001
72515878|NCT01763866|144562683|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|65.7|||<|0.001|TWO_SIDED|95.0|51.0|76.6||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on Cochran-Mantel Haenszel test stratified by the stratification factors (entry statin therapy and simvastatin contraindicated therapy usage).||||76.6|51.0|<0.001
72515879|NCT01763866|144562683|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|91.7|||<|0.001|TWO_SIDED|95.0|81.6|95.3||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on Cochran-Mantel Haenszel test stratified by the stratification factors (entry statin therapy and simvastatin contraindicated therapy usage).||||95.3|81.6|<0.001
72515880|NCT01763866|144562683|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|84.6|||<|0.001|TWO_SIDED|95.0|72.8|90.0||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on Cochran-Mantel Haenszel test stratified by the stratification factors (entry statin therapy and simvastatin contraindicated therapy usage).||||90.0|72.8|<0.001
72515881|NCT01763866|144562684|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|83.5|||<|0.001|TWO_SIDED|95.0|71.9|89.2||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on Cochran-Mantel Haenszel test stratified by the stratification factors (entry statin therapy and simvastatin contraindicated therapy usage)||||89.2|71.9|<0.001
72515882|NCT01763866|144562684|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|78.3|||<|0.001|TWO_SIDED|95.0|65.2|85.3||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on Cochran-Mantel Haenszel test stratified by the stratification factors (entry statin therapy and simvastatin contraindicated therapy usage).||||85.3|65.2|<0.001
72515883|NCT01763866|144562684|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|63.0|||<|0.001|TWO_SIDED|95.0|47.3|73.9||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on Cochran-Mantel Haenszel test stratified by the stratification factors (entry statin therapy and simvastatin contraindicated therapy usage).||||73.9|47.3|<0.001
72515884|NCT01763866|144562684|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|64.9|||<|0.001|TWO_SIDED|95.0|49.8|75.2||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on Cochran-Mantel Haenszel test stratified by the stratification factors (entry statin therapy and simvastatin contraindicated therapy usage)||||75.2|49.8|<0.001
72568528|NCT04168190|144668493|OTHER|Estimated difference and CI are calculated based on the Miettinen \& Nurminen method|Difference in Percentage|3.3|||||TWO_SIDED|95.0|-16.0|22.8|||||Phase 1: V116 1.0 mL minus Phase 1: Pneumovax™23|Injection site swelling||22.8|-16.0|
72568529|NCT04168190|144668494|OTHER|Estimated difference and CI are calculated based on the Miettinen \& Nurminen method|Difference in Percentage|10.0|||||TWO_SIDED|95.0|-11.4|31.0|||||Phase 1: V116 0.5 mL minus Phase 1: Pneumovax™23|Fatigue||31.0|-11.4|
72568530|NCT04168190|144668494|OTHER|Estimated difference and CI are calculated based on the Miettinen \& Nurminen method|Difference in Percentage|10.0|||||TWO_SIDED|95.0|-11.4|31.0|||||Phase 1: V116 1.0 mL minus Phase 1: Pneumovax™23|Fatigue||31.0|-11.4|
72568531|NCT04168190|144668494|OTHER|Estimated difference and CI are calculated based on the Miettinen \& Nurminen method|Difference in Percentage|10.0|||||TWO_SIDED|95.0|-7.4|28.3|||||Phase 1: V116 0.5 mL minus Phase 1: Pneumovax™23|Arthralgia||28.3|-7.4|
72568532|NCT04168190|144668494|OTHER|Estimated difference and CI are calculated based on the Miettinen \& Nurminen method|Difference in Percentage|3.3|||||TWO_SIDED|95.0|-13.1|20.2|||||Phase 1: V116 1.0 mL minus Phase 1: Pneumovax™23|Arthralgia||20.2|-13.1|
72568533|NCT04168190|144668494|OTHER|Estimated difference and CI are calculated based on the Miettinen \& Nurminen method|Difference in Percentage|13.3|||||TWO_SIDED|95.0|-7.5|33.8|||||Phase 1: V116 0.5 mL minus Phase 1: Pneumovax™23|Myalgia||33.8|-7.5|
72568534|NCT04168190|144668494|OTHER|Estimated difference and CI are calculated based on the Miettinen \& Nurminen method|Difference in Percentage|16.7|||||TWO_SIDED|95.0|-4.6|37.3|||||Phase 1: V116 1.0 mL minus Phase 1: Pneumovax™23|Myalgia||37.3|-4.6|
72488577|NCT01197521|144505562|SUPERIORITY_OR_OTHER||Weighted difference in proportions|0.16|||<|0.001|TWO_SIDED|95.0|0.11|0.22||Nominal p-values presented. Formal statistical testing could not be carried out due to the predefined multiplicity procedure (as the primary variable comparisons were non-significant).|Mantel Haenszel|95% confidence intervals and p-values are calculated using a Mantel Haenszel approach stratified by pooled country.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||0.22|0.11|<0.001
72488578|NCT01197521|144505562|SUPERIORITY_OR_OTHER||Weighted difference in proportions|0.09||||0.002|TWO_SIDED|95.0|0.03|0.14||Nominal p-values presented. Formal statistical testing could not be carried out due to the predefined multiplicity procedure (as the primary variable comparisons were non-significant).|Mantel Haenszel|95% confidence intervals and p-values are calculated using a Mantel Haenszel approach stratified by pooled country.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||0.14|0.03|0.002
72488579|NCT01197521|144505563|SUPERIORITY_OR_OTHER||Weighted difference in proportions|0.08|||<|0.001|TWO_SIDED|95.0|0.05|0.12||Nominal p-values presented. Formal statistical testing could not be carried out due to the predefined multiplicity procedure (as the primary variable comparisons were non-significant).|Mantel Haenszel|95% confidence intervals and p-values are calculated using a Mantel Haenszel approach stratified by pooled country.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||0.12|0.05|<0.001
72488580|NCT01197521|144505563|SUPERIORITY_OR_OTHER||Weighted difference in proportions|0.04||||0.015|TWO_SIDED|95.0|0.01|0.07||Nominal p-values presented. Formal statistical testing could not be carried out due to the predefined multiplicity procedure (as the primary variable comparisons were non-significant).|Mantel Haenszel|95% confidence intervals and p-values are calculated using a Mantel Haenszel approach stratified by pooled country.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||0.07|0.01|0.015
72488581|NCT01197521|144505564|SUPERIORITY_OR_OTHER||||||<|0.001||||||Nominal p-value presented for treatment comparison. ACRn was not formally tested within the predefined multiplicity procedure. As this is a non-parametric test p-values alone are presented rather than an estimated treatment difference.|Van Elteren|The treatment differences, 95% CIs and p-values are estimated using the Van Elteren test stratified by pooled country.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||||<0.001
72515885|NCT01763866|144562684|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|80.1|||<|0.001|TWO_SIDED|95.0|65.8|87.9||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on Cochran-Mantel Haenszel test stratified by the stratification factors (entry statin therapy and simvastatin contraindicated therapy usage).||||87.9|65.8|<0.001
72515886|NCT01763866|144562684|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|81.2|||<|0.001|TWO_SIDED|95.0|67.9|88.1||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on Cochran-Mantel Haenszel test stratified by the stratification factors (entry statin therapy and simvastatin contraindicated therapy usage)||||88.1|67.9|<0.001
72515887|NCT01763866|144562684|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|41.1|||<|0.001|TWO_SIDED|95.0|26.4|55.1||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on Cochran-Mantel Haenszel test stratified by the stratification factors (entry statin therapy and simvastatin contraindicated therapy usage).||||55.1|26.4|<0.001
72515888|NCT01763866|144562684|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|35.2|||<|0.001|TWO_SIDED|95.0|20.7|49.3||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on Cochran-Mantel Haenszel test stratified by the stratification factors (entry statin therapy and simvastatin contraindicated therapy usage).||||49.3|20.7|<0.001
72515889|NCT01763866|144562684|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|77.3|||<|0.001|TWO_SIDED|95.0|63.9|84.7||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on Cochran-Mantel Haenszel test stratified by the stratification factors (entry statin therapy and simvastatin contraindicated therapy usage).||||84.7|63.9|<0.001
72515890|NCT01763866|144562684|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|81.1|||<|0.001|TWO_SIDED|95.0|68.8|87.5||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on Cochran-Mantel Haenszel test stratified by the stratification factors (entry statin therapy and simvastatin contraindicated therapy usage).||||87.5|68.8|<0.001
72515891|NCT01763866|144562684|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|52.7|||<|0.001|TWO_SIDED|95.0|37.6|65.3||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on Cochran-Mantel Haenszel test stratified by the stratification factors (entry statin therapy and simvastatin contraindicated therapy usage).||||65.3|37.6|<0.001
72515892|NCT01763866|144562684|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|64.3|||<|0.001|TWO_SIDED|95.0|49.1|75.5||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on Cochran-Mantel Haenszel test stratified by the stratification factors (entry statin therapy and simvastatin contraindicated therapy usage).||||75.5|49.1|<0.001
72404029|NCT04476030|144314578|SUPERIORITY||Odds Ratio (OR)|1.15||||0.4946|TWO_SIDED|95.0|0.78|1.69|||Binary Response Model||GEE for binary response model was used with factors for treatment, baseline HAMD-17 total score, antidepressant use (SSRI/SNRI), assessment time point, and time point-by-treatment interaction with unstructured covariance structure.|Day 15|Generalized estimating equation is abbreviated as GEE in the method of estimation section.|1.69|0.78|0.4946
72488582|NCT01197521|144505564|SUPERIORITY_OR_OTHER|||||||0.002||||||Nominal p-value presented for treatment comparison. ACRn was not formally tested within the predefined multiplicity procedure. As this is a non-parametric test p-values alone are presented rather than an estimated treatment difference.|Van Elteren|The treatment differences, 95% CIs and p-values are estimated using the Van Elteren test stratified by pooled country.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||||0.002
72488583|NCT01197521|144505565|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.0|||<|0.001|TWO_SIDED|95.0|2.44|14.64||Nominal p-values presented. Formal statistical testing could not be carried out due to the predefined multiplicity procedure (as the primary variable comparisons were non-significant).|Regression, Logistic|Odds ratio and 95% confidence intervals are calculated using Logistic Regression with treatment and pooled country as factors.|An odds ratio \>1 indicates a benefit towards Fostamatinib.|Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||14.64|2.44|<0.001
72515893|NCT01763866|144562684|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|92.5|||<|0.001|TWO_SIDED|95.0|82.3|95.9||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on Cochran-Mantel Haenszel test stratified by the stratification factors (entry statin therapy and simvastatin contraindicated therapy usage).||||95.9|82.3|<0.001
72404030|NCT04476030|144314578|SUPERIORITY||Odds Ratio (OR)|0.82||||0.3579|TWO_SIDED|95.0|0.55|1.24|||Binary Response Model||GEE for binary response model was used with factors for treatment, baseline HAMD-17 total score, antidepressant use (SSRI/SNRI), assessment time point, and time point-by-treatment interaction with unstructured covariance structure.|Day 42||1.24|0.55|0.3579
72404031|NCT04476030|144314579|SUPERIORITY||Odds Ratio (OR)|1.41||||0.1417|TWO_SIDED|95.0|0.89|2.24|||Binary Response Model||GEE for binary response model was used with factors for treatment, baseline HAMD-17 total score, antidepressant use (SSRI/SNRI), assessment time point, and time point-by-treatment interaction with unstructured covariance structure.|Day 15||2.24|0.89|0.1417
72404032|NCT04476030|144314579|SUPERIORITY||Odds Ratio (OR)|0.94||||0.7872|TWO_SIDED|95.0|0.62|1.44|||Binary Response Model||GEE for binary response model was used with factors for treatment, baseline HAMD-17 total score, antidepressant use (SSRI/SNRI), assessment time point, and time point-by-treatment interaction with unstructured covariance structure.|Day 42||1.44|0.62|0.7872
72404033|NCT04476030|144314580|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.13||0.1993|TWO_SIDED|95.0|-0.4|0.1|||MMRM||Model used was the MMRM with treatment, baseline CGI-S score, antidepressant use (SSRI/SNRI), assessment time point, and time point-by-treatment interaction as fixed effects with unstructured covariance structure.|||0.1|-0.4|0.1993
72404034|NCT04476030|144314581|SUPERIORITY||Odds Ratio (OR)|2.05||||0.0079|TWO_SIDED|95.0|1.21|3.47|||Binary Response Model||GEE for binary response model was used with factors for treatment, baseline CGI-S score, antidepressant use (SSRI/SNRI), assessment time point, and time point-by-treatment interaction with unstructured covariance structure.|Day 3||3.47|1.21|0.0079
72404035|NCT04476030|144314581|SUPERIORITY||Odds Ratio (OR)|1.09||||0.6588|TWO_SIDED|95.0|0.74|1.62|||Binary Response Model||GEE for binary response model was used with factors for treatment, baseline CGI-S score, antidepressant use (SSRI/SNRI), assessment time point, and time point-by-treatment interaction with unstructured covariance structure.|Day 15||1.62|0.74|0.6588
72515894|NCT01763866|144562684|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|78.4|||<|0.001|TWO_SIDED|95.0|64.9|85.4||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on Cochran-Mantel Haenszel test stratified by the stratification factors (entry statin therapy and simvastatin contraindicated therapy usage).||||85.4|64.9|<0.001
72515895|NCT01763866|144562685|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-32.08|STANDARD_ERROR_OF_MEAN|3.54|<|0.001|TWO_SIDED|95.0|-39.06|-25.11||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-25.11|-39.06|<0.001
72515896|NCT01763866|144562685|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-21.86|STANDARD_ERROR_OF_MEAN|3.98|<|0.001|TWO_SIDED|95.0|-29.7|-14.03||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-14.03|-29.70|<0.001
72568535|NCT04168190|144668494|OTHER|Estimated difference and CI are calculated based on the Miettinen \& Nurminen method|Difference in Percentage|13.3|||||TWO_SIDED|95.0|-8.5|34.5|||||Phase 1: V116 0.5 mL minus Phase 1: Pneumovax™23|Headache||34.5|-8.5|
72568536|NCT04168190|144668494|OTHER|Estimated difference and CI are calculated based on the Miettinen \& Nurminen method|Difference in Percentage|3.3|||||TWO_SIDED|95.0|-17.2|23.8|||||Phase 1: V116 1.0 mL minus Phase 1: Pneumovax™23|Headache||23.8|-17.2|
72568537|NCT04168190|144668495|OTHER|Estimated difference and CI are calculated based on the Miettinen \& Nurminen method|Difference in Percentage|0.0|||||TWO_SIDED|95.0|-11.5|11.5|||||Phase 1: V116 0.5 mL minus Phase 1: Pneumovax™23|||11.5|-11.5|
72404036|NCT04476030|144314582|SUPERIORITY||LS Mean Difference|-1.3|STANDARD_ERROR_OF_MEAN|1.06||0.2322|TWO_SIDED|95.0|-3.4|0.8|||MMRM||Model used was the MMRM with treatment, baseline MADRS total score, antidepressant use (SSRI/SNRI), assessment time point, and time point-by-treatment interaction as fixed effects with unstructured covariance structure.|||0.8|-3.4|0.2322
72404037|NCT04476030|144314583|SUPERIORITY||Odds Ratio (OR)|1.13||||0.5439|TWO_SIDED|95.0|0.76|1.68|||Binary Response Model||GEE for binary response model was used with factors for treatment, baseline MADRS total score, antidepressant use (SSRI/SNRI), assessment time point, and time point-by-treatment interaction with unstructured covariance structure.|||1.68|0.76|0.5439
72404038|NCT04476030|144314584|SUPERIORITY||Odds Ratio (OR)|1.09||||0.7054|TWO_SIDED|95.0|0.7|1.69|||Binary Response Model||GEE for binary response model was used with factors for treatment, baseline MADRS total score, antidepressant use (SSRI/SNRI), assessment time point, and time point-by-treatment interaction with unstructured covariance structure.|||1.69|0.70|0.7054
72404039|NCT04476030|144314585|SUPERIORITY||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.62||0.4188|TWO_SIDED|95.0|-1.7|0.7|||MMRM||Model used was the MMRM with treatment, baseline HAM-A total score, antidepressant use (SSRI/SNRI), assessment time point, and time point-by-treatment interaction as fixed effects with unstructured covariance structure.|||0.7|-1.7|0.4188
72404040|NCT04476030|144314587|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.62||0.7758|TWO_SIDED|95.0|-1.4|1.0|||MMRM||Model used was the MMRM with treatment, baseline PHQ-9 total score, antidepressant use (SSRI/SNRI), assessment time point, and time point-by-treatment interaction as fixed effects with unstructured covariance structure.|||1.0|-1.4|0.7758
72488584|NCT01197521|144505565|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.4||||0.002|TWO_SIDED|95.0|1.76|11.02||Nominal p-values presented. Formal statistical testing could not be carried out due to the predefined multiplicity procedure (as the primary variable comparisons were non-significant).|Regression, Logistic|Odds ratio and 95% confidence intervals are calculated using Logistic Regression with treatment and pooled country as factors.|An odds ratio \>1 indicates a benefit towards Fostamatinib.|Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||11.02|1.76|0.002
72488585|NCT01197521|144505566|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.0|||<|0.001|TWO_SIDED|95.0|1.63|5.67||Nominal p-values presented. Formal statistical testing could not be carried out due to the predefined multiplicity procedure (as the primary variable comparisons were non-significant).|Regression, Logistic|Odds ratio and 95% confidence intervals are calculated using Logistic Regression with treatment and pooled country as factors.|An odds ratio \>1 indicates a benefit towards Fostamatinib.|Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||5.67|1.63|<0.001
72488586|NCT01197521|144505566|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.8||||0.083|TWO_SIDED|95.0|0.93|3.5||Nominal p-values presented. Formal statistical testing could not be carried out due to the predefined multiplicity procedure (as the primary variable comparisons were non-significant).|Regression, Logistic|Odds ratio and 95% confidence intervals are calculated using Logistic Regression with treatment and pooled country as factors.|An odds ratio \>1 indicates a benefit towards Fostamatinib.|Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||3.50|0.93|0.083
72488587|NCT01197521|144505567|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.43|||<|0.001|TWO_SIDED|95.0|1.79|3.3||Nominal p-value presented for treatment comparison. This was not formally tested within the predefined multiplicity procedure.|Proportional odds model|No response, moderate response and good response are included in the proportional odds model with treatment and pooled country as factors.|An odds ratio \>1 indicates a benefit towards fostamatinib.|Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||3.30|1.79|<0.001
72488588|NCT01197521|144505567|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.57||||0.004|TWO_SIDED|95.0|1.16|2.14||Nominal p-value presented for treatment comparison. This was not formally tested within the predefined multiplicity procedure.|Proportional odds model|No response, moderate response and good response are included in the proportional odds model with treatment and pooled country as factors.|An odds ratio \>1 indicates a benefit towards Fostamatinib.|Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||2.14|1.16|0.004
72488589|NCT01197521|144505568|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.3|||<|0.001|TWO_SIDED|95.0|1.68|3.26||Nominal p-values presented. Formal statistical testing could not be carried out due to the predefined multiplicity procedure (as the primary variable comparisons were non-significant).|Regression, Logistic|Odds ratio and 95% confidence intervals are calculated using Logistic Regression with treatment and pooled country as factors.|An odds ratio \>1 indicates a benefit towards Fostamatinib.|Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||3.26|1.68|<0.001
72488590|NCT01197521|144505568|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.9|||<|0.001|TWO_SIDED|95.0|1.38|2.68||Nominal p-values presented. Formal statistical testing could not be carried out due to the predefined multiplicity procedure (as the primary variable comparisons were non-significant).|Regression, Logistic|Odds ratio and 95% confidence intervals are calculated using Logistic Regression with treatment and pooled country as factors.|An odds ratio \>1 indicates a benefit towards Fostamatinib.|Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||2.68|1.38|<0.001
72515897|NCT01763866|144562685|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-27.45|STANDARD_ERROR_OF_MEAN|3.59|<|0.001|TWO_SIDED|95.0|-34.53|-20.38||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-20.38|-34.53|<0.001
72515898|NCT01763866|144562685|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-29.49|STANDARD_ERROR_OF_MEAN|3.99|<|0.001|TWO_SIDED|95.0|-37.36|-21.62||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-21.62|-37.36|<0.001
72404041|NCT02404311|144314619|OTHER||Proportion Difference (Net)|-0.015||||1|TWO_SIDED|||||The threshold for statistical significance was p = 0.05.|McNemar||Difference = Month 12.5 (5th vaccination) - Month 6.5 (4th vaccination)|IgG Ab binding to 1086C\_D7gp120.avi/293F after the fourth (month 6.5) versus the fifth vaccination (month 12.5)||||1.0000
72515899|NCT01763866|144562685|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-20.52|STANDARD_ERROR_OF_MEAN|3.65|<|0.001|TWO_SIDED|95.0|-27.71|-13.33||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-13.33|-27.71|<0.001
72515900|NCT01763866|144562685|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-28.96|STANDARD_ERROR_OF_MEAN|4.08|<|0.001|TWO_SIDED|95.0|-37.01|-20.92||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-20.92|-37.01|<0.001
72515901|NCT01763866|144562685|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-32.02|STANDARD_ERROR_OF_MEAN|3.6|<|0.001|TWO_SIDED|95.0|-39.11|-24.93||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-24.93|-39.11|<0.001
72515902|NCT01763866|144562685|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-37.42|STANDARD_ERROR_OF_MEAN|4.15|<|0.001|TWO_SIDED|95.0|-45.61|-29.23||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-29.23|-45.61|<0.001
72515903|NCT01763866|144562685|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-35.66|STANDARD_ERROR_OF_MEAN|3.69|<|0.001|TWO_SIDED|95.0|-42.94|-28.38||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-28.38|-42.94|<0.001
72515904|NCT01763866|144562685|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-26.81|STANDARD_ERROR_OF_MEAN|4.33|<|0.001|TWO_SIDED|95.0|-35.36|-18.27||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-18.27|-35.36|<0.001
72515905|NCT01763866|144562685|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-33.56|STANDARD_ERROR_OF_MEAN|3.64|<|0.001|TWO_SIDED|95.0|-40.74|-26.37||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-26.37|-40.74|<0.001
72515906|NCT01763866|144562685|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-32.19|STANDARD_ERROR_OF_MEAN|4.36|<|0.001|TWO_SIDED|95.0|-40.8|-23.58||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-23.58|-40.80|<0.001
72515907|NCT01763866|144562685|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-28.07|STANDARD_ERROR_OF_MEAN|3.46|<|0.001|TWO_SIDED|95.0|-34.91|-21.23||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-21.23|-34.91|<0.001
72515908|NCT01763866|144562685|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-27.16|STANDARD_ERROR_OF_MEAN|3.76|<|0.001|TWO_SIDED|95.0|-34.59|-19.73||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit||||-19.73|-34.59|<0.001
72515909|NCT01763866|144562686|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-33.2|STANDARD_ERROR_OF_MEAN|3.86|<|0.001|TWO_SIDED|95.0|-40.81|-25.6||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-25.60|-40.81|<0.001
72515910|NCT01763866|144562686|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-19.82|STANDARD_ERROR_OF_MEAN|4.11|<|0.001|TWO_SIDED|95.0|-27.92|-11.72||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-11.72|-27.92|<0.001
72515911|NCT01763866|144562686|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-29.16|STANDARD_ERROR_OF_MEAN|3.91|<|0.001|TWO_SIDED|95.0|-36.87|-21.44||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-21.44|-36.87|<0.001
72515912|NCT01763866|144562686|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-27.44|STANDARD_ERROR_OF_MEAN|4.12|<|0.001|TWO_SIDED|95.0|-35.56|-19.32||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-19.32|-35.56|<0.001
72515913|NCT01763866|144562686|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-22.38|STANDARD_ERROR_OF_MEAN|4.07|<|0.001|TWO_SIDED|95.0|-30.39|-14.36||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-14.36|-30.39|<0.001
72568538|NCT04168190|144668495|OTHER|Estimated difference and CI are calculated based on the Miettinen \& Nurminen method|Difference in Percentage|0.0|||||TWO_SIDED|95.0|-11.5|11.5|||||Phase 1: V116 1.0 mL minus Phase 1: Pneumovax™23|||11.5|-11.5|
72488591|NCT01197521|144505569|SUPERIORITY_OR_OTHER||Treatment difference|2.24|||<|0.001||95.0|1.16|3.31||Nominal p-value presented for treatment comparison. This was not formally tested within the predefined multiplicity procedure.|ANCOVA|Including terms for baseline as a continuous covariate and treatment and pooled country as factors.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||3.31|1.16|<0.001
72488592|NCT01197521|144505569|SUPERIORITY_OR_OTHER||Treatment difference|1.27||||0.02||95.0|0.2|2.35||Nominal p-value presented for treatment comparison. This was not formally tested within the predefined multiplicity procedure.|ANCOVA|Including terms for baseline as a continuous covariate and treatment and pooled country as factors.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||2.35|0.20|0.020
72488593|NCT01197521|144505570|SUPERIORITY_OR_OTHER||Treatment difference|1.8||||0.005||95.0|0.54|3.07||Nominal p-value presented for treatment comparison. This was not formally tested within the predefined multiplicity procedure.|ANCOVA|Including terms for baseline as a continuous covariate and treatment and pooled country as factors.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||3.07|0.54|0.005
72488594|NCT01197521|144505570|SUPERIORITY_OR_OTHER||Treatment difference|1.56||||0.017||95.0|0.28|2.83||Nominal p-value presented for treatment comparison. This was not formally tested within the predefined multiplicity procedure.|ANCOVA|Including terms for baseline as a continuous covariate and treatment and pooled country as factors.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||2.83|0.28|0.017
72488595|NCT04206605|144505581|SUPERIORITY||Rate Ratio|1.02|||=|0.899|TWO_SIDED|95.0|0.71|1.47||P-value was from Wald-based chi-square test; unadjusted for multiple testing.|Chi-squared|||||1.47|0.71|=0.899
72488596|NCT04206605|144505582|SUPERIORITY||Risk Difference (RD)|0.003|||=|1|TWO_SIDED|95.0|-0.153|0.114||P-value was from the corresponding Mantel-Haenszel estimate for the common risk difference from Cochran-Mantel-Haenszel (CMH) test; unadjusted for multiple testing.|Cochran-Mantel-Haenszel|||||0.114|-0.153|=1.000
72488597|NCT04206605|144505583|SUPERIORITY||Rate Ratio|0.96|||=|0.852|TWO_SIDED|95.0|0.62|1.48||P-value was from Wald-based chi-square test; unadjusted for multiple testing.|Chi-squared|||||1.48|0.62|=0.852
72488598|NCT04206605|144505584|SUPERIORITY||Rate Ratio|1.1|||=|0.66|TWO_SIDED|95.0|0.72|1.7||P-value was from Wald-based chi-square test; unadjusted for multiple testing.|Chi-squared|||||1.70|0.72|=0.660
72488599|NCT04206605|144505585|SUPERIORITY||Risk Difference (RD)|-0.087|||=|0.25|TWO_SIDED|95.0|-0.28|0.063||P-value was from the corresponding Mantel-Haenszel estimate for the common risk difference from CMH test; unadjusted for multiple testing.|Cochran-Mantel-Haenszel|||||0.063|-0.280|=0.250
72488600|NCT04206605|144505587|SUPERIORITY||Rate Ratio|0.97|||=|0.896|TWO_SIDED|95.0|0.58|1.61||P-value was from Wald-based chi-square test; unadjusted for multiple testing.|Chi-squared|||||1.61|0.58|=0.896
72488601|NCT04206605|144505589|SUPERIORITY||||||=|0.498||||||P-value comparing lanadelumab to placebo was from a log rank test stratified by baseline strata.|Log Rank|||||||=0.498
72624315|NCT00863304|144778629|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.66|STANDARD_ERROR_OF_MEAN|0.22||0.003|TWO_SIDED|95.0|-1.09|-0.23||P-value was based on pairwise comparisons.|ANCOVA|||Week 2: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.23|-1.09|0.003
72488602|NCT04206605|144505590|SUPERIORITY||||||=|0.184||||||P-value comparing lanadelumab to placebo was from a log rank test stratified by baseline strata.|Log Rank|||||||=0.184
72488603|NCT00078325|144505605|SUPERIORITY_OR_OTHER|||||||0.0001|||||||ANOVA|Treatment and country as factors.||||||0.0001
72488604|NCT00078325|144505605|SUPERIORITY_OR_OTHER|||||||0.0008|||||||ANOVA|Treatment and country as factors.||||||0.0008
72488605|NCT00078325|144505606|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Cochran-Mantel-Haenszel|Adjusted for country.||||||<0.0001
72488606|NCT00078325|144505606|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Cochran-Mantel-Haenszel|Adjusted for country.||||||<0.0001
72488607|NCT00578136|144505607|SUPERIORITY_OR_OTHER|||||||0.008|||||||Wilcoxon (Mann-Whitney)|The Wilcoxon rank-sum test was used because the study did not have a normal distribution using the Kolmogorov-Smirnov test (p\<0.01).||Assuming the opioid requirement in the local infiltration group to be 0.2mg kg-1 and in the rectus sheath block group to be 0.1mg kg-1, a sample size of 44 patients (22 in each group) will have a power of 80% to detect a difference in means of 0.1mg kg-1 with a 0.005 two-sided significance level.||||0.008
72488608|NCT02012621|144505684|OTHER||Odds Ratio (OR)|73.5|||<|0.0001|TWO_SIDED|95.0|25.7|210.5|||Regression, Logistic|||||210.5|25.7|<0.0001
72488609|NCT02012621|144505685|OTHER||Odds Ratio (OR)|8.5||||0.0012|TWO_SIDED|95.0|2.3|30.9|||Regression, Logistic|||||30.9|2.3|0.0012
72488610|NCT02012621|144505686|OTHER||Odds Ratio (OR)|4.7|||<|0.0001|TWO_SIDED|95.0|2.6|8.7|||Regression, Logistic|||||8.7|2.6|<0.0001
72488611|NCT04722042|144505687|SUPERIORITY|||||||0.557|||||||ANOVA|||comparison of word recognition over time (activation, and 1, 3, 6, and 12 months post-activation) between groups (default versus place-based)||||0.557
72488612|NCT04722042|144505688|SUPERIORITY|||||||0.208|||||||ANOVA|||comparison of spatial release from masking over time (1, 3, 6, and 12 months post-activation) between the groups (default versus place-based)||||0.208
72488613|NCT04722042|144505689|SUPERIORITY|||||||0.126|||||||ANOVA|||comparison of spatial release from masking between the groups over time||||0.126
72488614|NCT04722042|144505690|SUPERIORITY|||||||0.369|||||||ANOVA|||comparison of perceived benefit between the groups over time||||0.369
72624316|NCT00863304|144778629|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.82|STANDARD_ERROR_OF_MEAN|0.22|<|0.001|TWO_SIDED|95.0|-1.25|-0.39||P-value was based on pairwise comparisons.|ANCOVA|||Week 2: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.39|-1.25|<0.001
72404042|NCT02404311|144314619|OTHER||Proportion Difference (Net)|-0.015||||1|TWO_SIDED|||||The threshold for statistical significance was p = 0.05.|McNemar||Difference = Month 12.5 (5th vaccination) - Month 6.5 (4th vaccination)|IgG Ab binding to 96ZM651.D11gp120.avi after the fourth (month 6.5) versus the fifth vaccination (month 12.5)||||1.0000
72404043|NCT02404311|144314619|OTHER||Proportion Difference (Net)|-0.015||||1|TWO_SIDED|||||The threshold for statistical significance was p = 0.05.|McNemar||Difference = Month 12.5 (5th vaccination) - Month 6.5 (4th vaccination)|IgG Ab binding to TV1c8\_D11gp120.avi/293F after the fourth (month 6.5) versus the fifth vaccination (month 12.5)||||1.0000
72404044|NCT02404311|144314620|OTHER||Geometric Mean difference (Net)|0.914|||<|0.0001|TWO_SIDED|||||The threshold for statistical significance was p = 0.05.|Wilcoxon Signed-Rank||Difference = Month 12.5 (5th vaccination) - Month 6.5 (4th vaccination)|IgG Ab binding to 1086C\_D7gp120.avi/293F after the fourth (month 6.5) versus the fifth vaccination (month 12.5)||||<.0001
72404045|NCT02404311|144314620|OTHER||Geometric Mean difference (Net)|0.945|||<|0.0001|TWO_SIDED|||||The threshold for statistical significance was p = 0.05.|Wilcoxon Signed-Rank||Difference = Month 12.5 (5th vaccination) - Month 6.5 (4th vaccination)|IgG Ab binding to 96ZM651.D11gp120.avi after the fourth (month 6.5) versus the fifth vaccination (month 12.5)||||<.0001
72404046|NCT02404311|144314620|OTHER||Geometric Mean difference (Net)|0.895|||<|0.0001|TWO_SIDED|||||The threshold for statistical significance was p = 0.05.|Wilcoxon Signed-Rank||Difference = Month 12.5 (5th vaccination) - Month 6.5 (4th vaccination)|IgG Ab binding to TV1c8\_D11gp120.avi/293F after the fourth (month 6.5) versus the fifth vaccination (month 12.5)||||<.0001
72404047|NCT02404311|144314621|OTHER||Proportion Difference (Net)|0.0||||0.0215|TWO_SIDED|||||The threshold for statistical significance was p = 0.05.|McNemar||Difference = Month 12.5 (5th vaccination) - Month 6.5 (4th vaccination)|IgG Ab binding to C.1086C\_V1\_V2 Tags after the fourth (month 6.5) versus the fifth vaccination (month 12.5)||||0.0215
72404048|NCT02404311|144314621|OTHER||Proportion Difference (Net)|0.0||||0.0003|TWO_SIDED|||||The threshold for statistical significance was p = 0.05.|McNemar||Difference = Month 12.5 (5th vaccination) - Month 6.5 (4th vaccination)|IgG Ab binding to gp70-96ZM651.02 V1v2 after the fourth (month 6.5) versus the fifth vaccination (month 12.5)||||0.0003
72488615|NCT04722042|144505691|SUPERIORITY|||||||0.006|||||||t-test, 2 sided|||||||0.006
72488616|NCT04722042|144505692|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
72488617|NCT04722042|144505693|SUPERIORITY|||||||0.02|||||||t-test, 2 sided|||||||0.02
72488618|NCT02090413|144505694|SUPERIORITY_OR_OTHER||Difference in percentage|2.4|||||TWO_SIDED|95.0|-6.4|11.2|||||Two sided 95% CI of difference in proportions was constructed based on the normal approximation to the binomial distribution.|Weeks 1-4 combined||11.2|-6.4|
72488619|NCT02090413|144505694|SUPERIORITY_OR_OTHER||Difference in percentage|-1.3|||||TWO_SIDED|95.0|-10.8|8.3|||||Two sided 95% CI of difference in proportions was constructed based on the normal approximation to the binomial distribution.|Weeks 1-4 combined||8.3|-10.8|
72515914|NCT01763866|144562686|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-28.1|STANDARD_ERROR_OF_MEAN|4.32|<|0.001|TWO_SIDED|95.0|-36.62|-19.58||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-19.58|-36.62|<0.001
72488620|NCT02090413|144505694|SUPERIORITY_OR_OTHER||Difference in percentage|2.0|||||TWO_SIDED|95.0|-9.3|13.2|||||Two sided 95% CI of difference in proportions was constructed based on the normal approximation to the binomial distribution.|Week 1||13.2|-9.3|
72488621|NCT02090413|144505694|SUPERIORITY_OR_OTHER||Difference in percentage|0.0|||||TWO_SIDED|95.0|-11.4|11.4|||||Two sided 95% CI of difference in proportions was constructed based on the normal approximation to the binomial distribution.|Week 1||11.4|-11.4|
72515915|NCT01763866|144562686|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-32.62|STANDARD_ERROR_OF_MEAN|3.98|<|0.001|TWO_SIDED|95.0|-40.46|-24.78||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-24.78|-40.46|<0.001
72488622|NCT02090413|144505694|SUPERIORITY_OR_OTHER||Difference in percentage|-14.8|||||TWO_SIDED|95.0|-29.2|-0.3|||||Two sided 95% CI of difference in proportions was constructed based on the normal approximation to the binomial distribution.|Week 2||-0.3|-29.2|
72404049|NCT02404311|144314621|OTHER||Proportion Difference (Net)|0.228||||0.001|TWO_SIDED|||||The threshold for statistical significance was p = 0.05.|McNemar||Difference = Month 12.5 (5th vaccination) - Month 6.5 (4th vaccination)|IgG Ab binding to gp70-TV1.GSKvacV1V2/293F after the fourth (month 6.5) versus the fifth vaccination (month 12.5)||||0.0010
72404050|NCT02404311|144314622|OTHER||Geometric Mean difference (Net)|0.0|||<|0.0001|TWO_SIDED|||||The threshold for statistical significance was p = 0.05.|Wilcoxon Signed-Rank||Difference = Month 12.5 (5th vaccination) - Month 6.5 (4th vaccination)|IgG Ab binding to C.1086C\_V1\_V2 Tags after the fourth (month 6.5) versus the fifth vaccination (month 12.5)||||<.0001
72404051|NCT02404311|144314622|OTHER||Geometric Mean difference (Net)|0.0|||<|0.0001|TWO_SIDED|||||The threshold for statistical significance was p = 0.05.|Wilcoxon Signed-Rank||Difference = Month 12.5 (5th vaccination) - Month 6.5 (4th vaccination)|IgG Ab binding to gp70-96ZM651.02 V1v2 after the fourth (month 6.5) versus the fifth vaccination (month 12.5)||||<.0001
72404052|NCT02404311|144314622|OTHER||Geometric Mean difference (Net)|6.099||||0.0002|TWO_SIDED|||||The threshold for statistical significance was p = 0.05.|Wilcoxon Signed-Rank||Difference = Month 12.5 (5th vaccination) - Month 6.5 (4th vaccination)|IgG Ab binding to gp70-TV1.GSKvacV1V2/293F after the fourth (month 6.5) versus the fifth vaccination (month 12.5)||||0.0002
72404053|NCT02404311|144314623|OTHER||Proportion Difference (Net)|0.018||||1|TWO_SIDED|||||The threshold for statistical significance was p = 0.05.|McNemar||Difference = Month 12.5 (5th vaccination) - Month 6.5 (4th vaccination)|CD4+ T Cell Responses to 1086 gp120 after the fourth (month 6.5) versus the fifth vaccination (month 12.5)||||1.0000
72488623|NCT02090413|144505694|SUPERIORITY_OR_OTHER||Difference in percentage|-7.0|||||TWO_SIDED|95.0|-20.9|6.9|||||Two sided 95% CI of difference in proportions was constructed based on the normal approximation to the binomial distribution.|Week 2||6.9|-20.9|
72404054|NCT02404311|144314623|OTHER||Proportion Difference (Net)|0.036||||0.6698|TWO_SIDED|||||The threshold for statistical significance was p = 0.05.|McNemar||Difference = Month 12.5 (5th vaccination) - Month 6.5 (4th vaccination)|CD4+ T Cell Responses to TV1 gp120 after the fourth (month 6.5) versus the fifth vaccination (month 12.5)||||0.6698
72404055|NCT02404311|144314623|OTHER||Proportion Difference (Net)|0.125||||0.1435|TWO_SIDED|||||The threshold for statistical significance was p = 0.05.|McNemar||Difference = Month 12.5 (5th vaccination) - Month 6.5 (4th vaccination)|CD4+ T Cell Responses to ZM96 gp120 after the fourth (month 6.5) versus the fifth vaccination (month 12.5)||||0.1435
72404056|NCT02404311|144314624|OTHER||Geometric Mean difference (Net)|0.965||||0.9661|TWO_SIDED|||||The threshold for statistical significance was p = 0.05.|Wilcoxon Signed-Rank||Difference = Month 12.5 (5th vaccination) - Month 6.5 (4th vaccination)|CD4+ T Cell Responses to 1086 gp120 after the fourth (month 6.5) versus the fifth vaccination (month 12.5)||||0.9661
72404057|NCT02404311|144314624|OTHER||Geometric Mean difference (Net)|1.118||||0.8593|TWO_SIDED|||||The threshold for statistical significance was p = 0.05.|Wilcoxon Signed-Rank||Difference = Month 12.5 (5th vaccination) - Month 6.5 (4th vaccination)|CD4+ T Cell Responses to TV1 gp120 after the fourth (month 6.5) versus the fifth vaccination (month 12.5)||||0.8593
72404058|NCT02404311|144314624|OTHER||Geometric Mean difference (Net)|1.138||||0.4396|TWO_SIDED|||||The threshold for statistical significance was p = 0.05.|Wilcoxon Signed-Rank||Difference = Month 12.5 (5th vaccination) - Month 6.5 (4th vaccination)|CD4+ T Cell Responses to ZM96 gp120 after the fourth (month 6.5) versus the fifth vaccination (month 12.5)||||0.4396
72404059|NCT00218296|144314631|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.51||||0.04|TWO_SIDED|95.0|0.26|0.99|||Chi-squared|There were no adjustments in the analysis.|The reference group for the odds ratio estimate is the usual care condition, i.e., the immediate cessation condition.|The null hypothesis was that the Usual Care Group (i.e. the immediate cessation group) and the Reduction Group had the same cessation rate. The alternative hypothesis was that they had different cessation rates. Two-sided test with a type I error of 0.05 was used.||0.99|0.26|0.04
72488624|NCT02090413|144505694|SUPERIORITY_OR_OTHER||Difference in percentage|-17.6|||||TWO_SIDED|95.0|-32.8|-2.4|||||Two sided 95% CI of difference in proportions was constructed based on the normal approximation to the binomial distribution.|Week 3||-2.4|-32.8|
72488625|NCT02090413|144505694|SUPERIORITY_OR_OTHER||Difference in percentage|-19.0|||||TWO_SIDED|95.0|-34.1|-3.9|||||Two sided 95% CI of difference in proportions was constructed based on the normal approximation to the binomial distribution.|Week 3||-3.9|-34.1|
72488626|NCT02090413|144505694|SUPERIORITY_OR_OTHER||Difference in percentage|-4.8|||||TWO_SIDED|95.0|-21.0|11.4|||||Two sided 95% CI of difference in proportions was constructed based on the normal approximation to the binomial distribution.|Week 4||11.4|-21.0|
72488627|NCT02090413|144505694|SUPERIORITY_OR_OTHER||Difference in percentage|-4.8|||||TWO_SIDED|95.0|-21.0|11.4|||||Two sided 95% CI of difference in proportions was constructed based on the normal approximation to the binomial distribution.|Week 4||11.4|-21.0|
72488628|NCT02090413|144505695|SUPERIORITY_OR_OTHER||Difference in percentage|4.9|||||TWO_SIDED|95.0|-2.6|12.4|||||Two sided 95% CI of difference in proportions was constructed based on the normal approximation to the binomial distribution.|Overall flushing events||12.4|-2.6|
72488629|NCT02090413|144505695|SUPERIORITY_OR_OTHER||Difference in percentage|5.0|||||TWO_SIDED|95.0|-2.5|12.5|||||Two sided 95% CI of difference in proportions was constructed based on the normal approximation to the binomial distribution.|Overall flushing events||12.5|-2.5|
72488630|NCT02090413|144505695|SUPERIORITY_OR_OTHER||Difference in percentage|-1.5|||||TWO_SIDED|95.0|-11.2|8.1|||||Two sided 95% CI of difference in proportions was constructed based on the normal approximation to the binomial distribution.|Overall redness events||8.1|-11.2|
72488631|NCT02090413|144505695|SUPERIORITY_OR_OTHER||Difference in percentage|-1.3|||||TWO_SIDED|95.0|-10.8|8.3|||||Two sided 95% CI of difference in proportions was constructed based on the normal approximation to the binomial distribution.|Overall redness events||8.3|-10.8|
72515916|NCT01763866|144562686|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-34.88|STANDARD_ERROR_OF_MEAN|4.38|<|0.001|TWO_SIDED|95.0|-43.52|-26.25||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-26.25|-43.52|<0.001
72568539|NCT04168190|144668496|OTHER|Estimated difference and CI are calculated based on the Miettinen \& Nurminen method|Difference in Percentage|2.0|||||TWO_SIDED|95.0|-2.8|6.8|||||Phase 2: V116 minus Phase 2: Pneumovax™23|Injection site erythema||6.8|-2.8|
72404060|NCT00218296|144314632|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.28||||0.019|TWO_SIDED|95.0|0.07|0.83|||Chi-squared|There were no adjustments in the analysis.|The reference group for the odds ratio estimate is the Usual Care condition, i.e., the immediate cessation condition.|The null hypothesis was that the Usual Care Group (i.e. the immediate cessation group) and the Reduction Group had the same cessation rate. The alternative hypothesis was that they had different cessation rates. Two-sided test with a type I error of 0.05 was used.||0.83|0.07|0.019
72404061|NCT00218296|144314633|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.42||||0.03|TWO_SIDED|95.0|0.18|0.94|||Chi-squared|There were no adjustments in the analysis.|The reference group for the odds ratio estimate is the usual care condition, i.e., the immediate cessation condition.|The null hypothesis was that the Usual Care Group (i.e. the immediate cessation group) and the Reduction Group had the same cessation rate. The alternative hypothesis was that they had different cessation rates. Two-sided test with a type I error of 0.05 was used.||0.94|0.18|0.03
72488632|NCT02090413|144505695|SUPERIORITY_OR_OTHER||Difference in percentage|4.9|||||TWO_SIDED|95.0|-1.8|11.7|||||Two sided 95% CI of difference in proportions was constructed based on the normal approximation to the binomial distribution.|Overall warmth events||11.7|-1.8|
72488633|NCT02090413|144505695|SUPERIORITY_OR_OTHER||Difference in percentage|5.0|||||TWO_SIDED|95.0|-1.7|11.7|||||Two sided 95% CI of difference in proportions was constructed based on the normal approximation to the binomial distribution.|Overall warmth events||11.7|-1.7|
72488634|NCT02090413|144505695|SUPERIORITY_OR_OTHER||Difference in percentage|5.9|||||TWO_SIDED|95.0|-5.4|17.3|||||Two sided 95% CI of difference in proportions was constructed based on the normal approximation to the binomial distribution.|Overall tingling events||17.3|-5.4|
72404062|NCT00218296|144314634|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.09||||0.002|TWO_SIDED|95.0|0.004|0.48|||Chi-squared|There were no adjustments in the analysis.|The reference group for the odds ratio estimate is the Usual Care Condition, i.e., the immediate cessation condition.|The null hypothesis was that the Usual Care Group (i.e. the immediate cessation group) and the Reduction Group had the same cessation rate. The alternative hypothesis was that they had different cessation rates. Two-sided test with a type I error of 0.05 was used.||0.48|0.004|.002
72488635|NCT02090413|144505695|SUPERIORITY_OR_OTHER||Difference in percentage|5.0|||||TWO_SIDED|95.0|-6.4|16.4|||||Two sided 95% CI of difference in proportions was constructed based on the normal approximation to the binomial distribution.|Overall tingling events||16.4|-6.4|
72488636|NCT02090413|144505695|SUPERIORITY_OR_OTHER||Difference in percentage|-8.0|||||TWO_SIDED|95.0|-19.5|3.5|||||Two sided 95% CI of difference in proportions was constructed based on the normal approximation to the binomial distribution.|Overall itching events||3.5|-19.5|
72488637|NCT02090413|144505695|SUPERIORITY_OR_OTHER||Difference in percentage|-11.3|||||TWO_SIDED|95.0|-23.1|0.6|||||Two sided 95% CI of difference in proportions was constructed based on the normal approximation to the binomial distribution.|Overall itching events||0.6|-23.1|
72488638|NCT02090413|144505698|SUPERIORITY_OR_OTHER||Difference in percentage|-1.4|||||TWO_SIDED|95.0|-15.8|13.0|||||Two sided 95% CI of difference in proportions was constructed based on the normal approximation to the binomial distribution.|Weeks 5-8 combined||13.0|-15.8|
72488639|NCT02090413|144505698|SUPERIORITY_OR_OTHER||Difference in percentage|5.4|||||TWO_SIDED|95.0|-8.4|19.1|||||Two sided 95% CI of difference in proportions was constructed based on the normal approximation to the binomial distribution.|Weeks 5-8 combined||19.1|-8.4|
72488640|NCT02090413|144505698|SUPERIORITY_OR_OTHER||Difference in percentage|6.5|||||TWO_SIDED|95.0|-9.9|23.0|||||Two sided 95% CI of difference in proportions was constructed based on the normal approximation to the binomial distribution.|Weeks 9-12 combined||23.0|-9.9|
72488641|NCT02090413|144505698|SUPERIORITY_OR_OTHER||Difference in percentage|15.7|||||TWO_SIDED|95.0|0.2|31.3|||||Two sided 95% CI of difference in proportions was constructed based on the normal approximation to the binomial distribution.|Weeks 9-12 combined||31.3|0.2|
72488642|NCT02090413|144505699|SUPERIORITY_OR_OTHER||Difference in percentage|2.6|||||TWO_SIDED|95.0|-10.2|15.4|||||Two sided 95% CI of difference in proportions was constructed based on the normal approximation to the binomial distribution.|Overall flushing, Weeks 5-8 combined||15.4|-10.2|
72488643|NCT02090413|144505699|SUPERIORITY_OR_OTHER||Difference in percentage|4.0|||||TWO_SIDED|95.0|-8.6|16.6|||||Two sided 95% CI of difference in proportions was constructed based on the normal approximation to the binomial distribution.|Overall flushing, Weeks 5-8 combined||16.6|-8.6|
72488644|NCT02090413|144505699|SUPERIORITY_OR_OTHER||Difference in percentage|3.1|||||TWO_SIDED|95.0|-12.8|18.9|||||Two sided 95% CI of difference in proportions was constructed based on the normal approximation to the binomial distribution.|Overall flushing, Weeks 9-12 combined||18.9|-12.8|
72488645|NCT02090413|144505699|SUPERIORITY_OR_OTHER||Difference in percentage|12.3|||||TWO_SIDED|95.0|-2.8|27.3|||||Two sided 95% CI of difference in proportions was constructed based on the normal approximation to the binomial distribution.|Overall flushing, Weeks 9-12 combined||27.3|-2.8|
72488646|NCT02090413|144505699|SUPERIORITY_OR_OTHER||Difference in percentage|-1.8|||||TWO_SIDED|95.0|-15.7|12.2|||||Two sided 95% CI of difference in proportions was constructed based on the normal approximation to the binomial distribution.|Redness, Weeks 5-8 combined||12.2|-15.7|
72488647|NCT02090413|144505699|SUPERIORITY_OR_OTHER||Difference in percentage|4.0|||||TWO_SIDED|95.0|-9.4|17.3|||||Two sided 95% CI of difference in proportions was constructed based on the normal approximation to the binomial distribution.|Redness, Weeks 5-8 combined||17.3|-9.4|
72488648|NCT02090413|144505699|SUPERIORITY_OR_OTHER||Difference in percentage|-9.0|||||TWO_SIDED|95.0|-25.1|7.0|||||Two sided 95% CI of difference in proportions was constructed based on the normal approximation to the binomial distribution.|Redness, Weeks 9-12 combined||7.0|-25.1|
72515917|NCT01763866|144562686|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-36.5|STANDARD_ERROR_OF_MEAN|4.15|<|0.001|TWO_SIDED|95.0|-44.69|-28.3||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-28.30|-44.69|<0.001
72515918|NCT01763866|144562686|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-25.34|STANDARD_ERROR_OF_MEAN|4.48|<|0.001|TWO_SIDED|95.0|-34.19|-16.49||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-16.49|-34.19|<0.001
72488649|NCT02090413|144505699|SUPERIORITY_OR_OTHER||Difference in percentage|3.3|||||TWO_SIDED|95.0|-12.0|18.5|||||Two sided 95% CI of difference in proportions was constructed based on the normal approximation to the binomial distribution.|Redness, Weeks 9-12 combined||18.5|-12.0|
72488650|NCT02090413|144505699|SUPERIORITY_OR_OTHER||Difference in percentage|-0.3|||||TWO_SIDED|95.0|-13.5|12.9|||||Two sided 95% CI of difference in proportions was constructed based on the normal approximation to the binomial distribution.|Warmth, Weeks 5-8 combined||12.9|-13.5|
72488651|NCT02090413|144505699|SUPERIORITY_OR_OTHER||Difference in percentage|2.6|||||TWO_SIDED|95.0|-10.2|15.4|||||Two sided 95% CI of difference in proportions was constructed based on the normal approximation to the binomial distribution.|Warmth, Weeks 5-8 combined||15.4|-10.2|
72488652|NCT02090413|144505699|SUPERIORITY_OR_OTHER||Difference in percentage|0.2|||||TWO_SIDED|95.0|-15.3|15.7|||||Two sided 95% CI of difference in proportions was constructed based on the normal approximation to the binomial distribution.|Warmth, Weeks 9-12 combined||15.7|-15.3|
72488653|NCT02090413|144505699|SUPERIORITY_OR_OTHER||Difference in percentage|4.8|||||TWO_SIDED|95.0|-10.3|19.9|||||Two sided 95% CI of difference in proportions was constructed based on the normal approximation to the binomial distribution.|Warmth, Weeks 9-12 combined||19.9|-10.3|
72488654|NCT02090413|144505699|SUPERIORITY_OR_OTHER||Difference in percentage|-2.0|||||TWO_SIDED|95.0|-18.4|14.3|||||Two sided 95% CI of difference in proportions was constructed based on the normal approximation to the binomial distribution.|Tingling, Weeks 5-8 combined||14.3|-18.4|
72404063|NCT00218296|144314635|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.47||||0.056|TWO_SIDED|95.0|0.2|1.03|||Chi-squared|There were no adjustments in the analysis.|The reference group for the odds ratio estimate is the Usual Care Condition, i.e., the immediate cessation condition.|The null hypothesis was that the Usual Care Group (i.e. the immediate cessation group) and the Reduction Group had the same cessation rate. The alternative hypothesis was that they had different cessation rates. Two-sided test with a type I error of 0.05 was used.||1.03|0.20|0.056
72404064|NCT00218296|144314636|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.09||||0.002|TWO_SIDED|95.0|0.004|0.48||There were no adjustments in the analysis.|Chi-squared||The reference group for the odds ratio estimate is the Usual Care Condition, i.e., the immediate cessation condition.|The null hypothesis was that the Usual Care Group (i.e. the immediate cessation group) and the Reduction Group had the same cessation rate. The alternative hypothesis was that they had different cessation rates. Two-sided test with a type I error of 0.05 was used.||0.48|0.004|0.002
72404065|NCT03735667|144314672|NON_INFERIORITY|A Bayesian analysis based on 10,000 samples from the posterior distribution, using a piecewise exponential survival model. The criteria for non-inferiority is met if the posterior probability of non-inferiority is greater than the non-inferiority test threshold.|||||||||||||||||A Bayesian analysis was used to test the non-inferiority hypothesis for the primary endpoint using a non-inferiority margin of 8%. The pre-specified success criteria (the non-inferiority test threshold) was a posterior probability of non-inferiority greater than 97.5%. The observed posterior probability of non-inferiority was 77.9%. The posterior median percentage difference in the rate of the primary outcome was 6.63% (95% Bayesian credible interval: 3.04% to 10.20%).|||
72404066|NCT01094548|144314705|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Fisher Exact|||||||1.0000
72404067|NCT01094548|144314709|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.431||||0.094|TWO_SIDED|95.0|0.157|1.185|||Log Rank|||||1.185|0.157|0.0940
72404068|NCT01094548|144314710|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.666||||0.3919|TWO_SIDED|95.0|0.261|1.698|||Log Rank|||||1.698|0.261|0.3919
72404069|NCT02063737|144314748|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.3882||||0.083|TWO_SIDED|95.0|-0.8272|0.0508|||Mixed Models Analysis|adjusting for shift length|Adjusted difference between intervention groups (intervention - control) from the linear mixed model adjusting for shift length and repeated measures within individuals.|||0.0508|-0.8272|0.0830
72404070|NCT02063737|144314749|SUPERIORITY_OR_OTHER|||||||0.0114|TWO_SIDED||||||ANCOVA|adjusting for baseline measure||||||0.0114
72488655|NCT02090413|144505699|SUPERIORITY_OR_OTHER||Difference in percentage|13.7|||||TWO_SIDED|95.0|-1.9|29.3|||||Two sided 95% CI of difference in proportions was constructed based on the normal approximation to the binomial distribution.|Tingling, Weeks 5-8 combined||29.3|-1.9|
72488656|NCT02090413|144505699|SUPERIORITY_OR_OTHER||Difference in percentage|-5.2|||||TWO_SIDED|95.0|-22.1|11.8|||||Two sided 95% CI of difference in proportions was constructed based on the normal approximation to the binomial distribution.|Tingling, Weeks 9-12 combined||11.8|-22.1|
72488657|NCT02090413|144505699|SUPERIORITY_OR_OTHER||Difference in percentage|7.1|||||TWO_SIDED|95.0|-9.6|23.9|||||Two sided 95% CI of difference in proportions was constructed based on the normal approximation to the binomial distribution.|Tingling, Weeks 9-12 combined||23.9|-9.6|
72488658|NCT02090413|144505699|SUPERIORITY_OR_OTHER||Difference in percentage|9.4|||||TWO_SIDED|95.0|-6.8|25.5|||||Two sided 95% CI of difference in proportions was constructed based on the normal approximation to the binomial distribution.|Itching, Weeks 5-8 combined||25.5|-6.8|
72488659|NCT02090413|144505699|SUPERIORITY_OR_OTHER||Difference in percentage|9.4|||||TWO_SIDED|95.0|-6.8|25.5|||||Two sided 95% CI of difference in proportions was constructed based on the normal approximation to the binomial distribution.|Itching, Weeks 5-8||25.5|-6.8|
72624317|NCT00863304|144778629|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.12|STANDARD_ERROR_OF_MEAN|0.22||0.572|TWO_SIDED|95.0|-0.31|0.55||P-value was based on pairwise comparisons.|ANCOVA|||Week 2: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||0.55|-0.31|0.572
72404071|NCT02063737|144314750|SUPERIORITY_OR_OTHER|||||||0.99|TWO_SIDED||||||ANCOVA|adjusting for the baseline measure||||||.99
72404072|NCT02063737|144314751|SUPERIORITY_OR_OTHER|||||||0.0927|TWO_SIDED||||||ANCOVA|adjusted for baseline measure||||||0.0927
72404073|NCT02063737|144314752|SUPERIORITY_OR_OTHER|||||||0.0578|TWO_SIDED||||||ANCOVA|adjusting for the baseline measure||||||0.0578
72488660|NCT02090413|144505699|SUPERIORITY_OR_OTHER||Difference in percentage|3.8|||||TWO_SIDED|95.0|-13.2|20.8|||||Two sided 95% CI of difference in proportions was constructed based on the normal approximation to the binomial distribution.|Itching, Weeks 9-12 combined||20.8|-13.2|
72404074|NCT02063737|144314753|SUPERIORITY_OR_OTHER|||||||0.69|TWO_SIDED||||||ANCOVA|adjusting for baseline measure||||||0.69
72404075|NCT02063737|144314754|SUPERIORITY_OR_OTHER|||||||0.65|TWO_SIDED||||||ANCOVA|adjusting for baseline measure||||||0.65
72404076|NCT02063737|144314755|SUPERIORITY_OR_OTHER|||||||0.95|TWO_SIDED||||||ANCOVA|adjusting for baseline measure||||||0.95
72404077|NCT02063737|144314756|SUPERIORITY_OR_OTHER|||||||0.21|TWO_SIDED||||||ANCOVA|adjusting for baseline measure||||||0.21
72404078|NCT02063737|144314757|SUPERIORITY_OR_OTHER|||||||0.51|TWO_SIDED||||||ANCOVA|adjusting for baseline measure||||||0.51
72404079|NCT02063737|144314758|SUPERIORITY_OR_OTHER|||||||0.28|TWO_SIDED||||||ANCOVA|adjusting for baseline measure||||||0.28
72404080|NCT02063737|144314759|SUPERIORITY_OR_OTHER|||||||0.093|TWO_SIDED||||||ANCOVA|adjusting for baseline measure||||||0.0930
72404081|NCT02063737|144314760|SUPERIORITY_OR_OTHER|||||||0.56|TWO_SIDED||||||ANCOVA|adjusting for baseline measure||||||0.56
72404082|NCT02063737|144314761|SUPERIORITY_OR_OTHER|||||||0.2|TWO_SIDED||||||ANCOVA|adjusting for baseline measure||||||0.20
72488661|NCT02090413|144505699|SUPERIORITY_OR_OTHER||Difference in percentage|8.4|||||TWO_SIDED|95.0|-8.5|25.3|||||Two sided 95% CI of difference in proportions was constructed based on the normal approximation to the binomial distribution.|Itching, Weeks 9-12 combined||25.3|-8.5|
72488662|NCT02090413|144505703|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.145|||||TWO_SIDED|95.0|-0.414|0.125|||||Analysis of variance model (ANCOVA) model was used with treatment, center as effects and baseline characteristics as covariates.|Weeks 1-4 combined||0.125|-0.414|
72624318|NCT00863304|144778629|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.16|STANDARD_ERROR_OF_MEAN|0.22||0.467|TWO_SIDED|95.0|-0.27|0.59||P-value was based on pairwise comparisons.|ANCOVA|||Week 2: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||0.59|-0.27|0.467
72488663|NCT02090413|144505703|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.392|||||TWO_SIDED|95.0|-0.656|-0.128|||||ANCOVA model was used with treatment, center as effects and baseline characteristics as covariates.|Weeks 1-4 combined||-0.128|-0.656|
72488664|NCT02090413|144505703|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.247|||||TWO_SIDED|95.0|-0.507|0.012|||||ANCOVA model was used with treatment, center as effects and baseline characteristics as covariates.|Weeks 1-4 combined||0.012|-0.507|
72515919|NCT01763866|144562686|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-36.48|STANDARD_ERROR_OF_MEAN|3.78|<|0.001|TWO_SIDED|95.0|-43.95|-29.02||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-29.02|-43.95|<0.001
72515920|NCT01763866|144562686|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-32.17|STANDARD_ERROR_OF_MEAN|5.28|<|0.001|TWO_SIDED|95.0|-42.61|-21.74||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-21.74|-42.61|<0.001
72515921|NCT01763866|144562686|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-31.25|STANDARD_ERROR_OF_MEAN|3.62|<|0.001|TWO_SIDED|95.0|-38.4|-24.1||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-24.10|-38.40|<0.001
72568540|NCT04168190|144668496|OTHER|Estimated difference and CI are calculated based on the Miettinen \& Nurminen method|Difference in Percentage|8.7|||||TWO_SIDED|95.0|0.1|17.1|||||Phase 2: V116 minus Phase 2: Pneumovax™23|Injection site pain||17.1|0.1|
72488665|NCT02090413|144505703|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.376|||||TWO_SIDED|95.0|-0.193|0.945|||||ANCOVA model was used with treatment, center as effects and baseline characteristics as covariates.|Weeks 5-8 combined||0.945|-0.193|
72488666|NCT02090413|144505703|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.069|||||TWO_SIDED|95.0|-0.498|0.635|||||ANCOVA model was used with treatment, center as effects and baseline characteristics as covariates.|Weeks 5-8 combined||0.635|-0.498|
72488667|NCT02090413|144505703|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.308|||||TWO_SIDED|95.0|-0.867|0.251|||||ANCOVA model was used with treatment, center as effects and baseline characteristics as covariates.|Weeks 5-8 combined||0.251|-0.867|
72488668|NCT02090413|144505703|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.024|||||TWO_SIDED|95.0|-0.308|0.355|||||ANCOVA model was used with treatment, center as effects and baseline characteristics as covariates.|Weeks 9-12 combined||0.355|-0.308|
72488669|NCT02090413|144505703|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.06|||||TWO_SIDED|95.0|-0.374|0.254|||||ANCOVA model was used with treatment, center as effects and baseline characteristics as covariates.|Weeks 9-12 combined||0.254|-0.374|
72488670|NCT02090413|144505703|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.084|||||TWO_SIDED|95.0|-0.4|0.232|||||ANCOVA model was used with treatment, center as effects and baseline characteristics as covariates.|Weeks 9-12 combined||0.232|-0.4|
72568541|NCT04168190|144668496|OTHER|Estimated difference and CI are calculated based on the Miettinen \& Nurminen method|Difference in Percentage|3.1|||||TWO_SIDED|95.0|-2.0|8.4|||||Phase 2: V116 minus Phase 2: Pneumovax™23|Injection site swelling||8.4|-2.0|
72488671|NCT00487396|144505717|OTHER||||||<|0.0001|||||||McNemar|||"Pathologies were including in the analysis as follows:~* combination of CE+IC procedures but not detected by the combination of SBFT+IC procedures were marked as CE+IC new finding ;~* Pathologies detected by the combination of SBFT+IC procedures but not detected by the combination of CE+IC procedures were marked as SBFT+IC new finding event;~* Pathologies detected by the combination of CE+IC procedures and by the combination of SBFT+IC procedures were marked as same findings event."||||<0.0001
72515922|NCT01763866|144562686|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-28.17|STANDARD_ERROR_OF_MEAN|4.36|<|0.001|TWO_SIDED|95.0|-36.79|-19.55||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit||||-19.55|-36.79|<0.001
72568542|NCT04168190|144668497|OTHER|Estimated difference and CI are calculated based on the Miettinen \& Nurminen method|Difference in Percentage|7.1|||||TWO_SIDED|95.0|0.8|13.5|||||Phase 2: V116 minus Phase 2: Pneumovax™23|Fatigue||13.5|0.8|
72488672|NCT00487396|144505718|OTHER||||||<|0.0001|||||||McNemar|||"For each category, the numbers of found and missed pathologies were including in the analysis as follows:~* Pathologies detected by CE procedure but not detected by SBFT procedure were marked as CE new finding event;~* Pathologies detected by SBFT procedure but not detected by CE procedure were marked as SBFT new finding event;~* Pathologies detected by both procedures (i.e., CE and SBFT) were marked as same findings event."||||<0.0001
72568543|NCT04168190|144668497|OTHER|Estimated difference and CI are calculated based on the Miettinen \& Nurminen method|Difference in Percentage|0.0|||||TWO_SIDED|95.0|-3.8|3.8|||||Phase 2: V116 minus Phase 2: Pneumovax™23|Arthralgia||3.8|-3.8|
72488673|NCT00487396|144505719|OTHER|||||||0.085|||||||McNemar|||"Pathologies were including in the analysis as follows:~* Pathologies detected by CE procedure but not detected by IC procedure were marked as CE new finding event;~* Pathologies detected by IC procedure but not detected by CE procedure were marked as IC new finding event;~* Pathologies detected by both procedures (i.e., CE and IC) were marked as same findings event."||||0.085
72488674|NCT02321930|144505730|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||Analysis performed to test for the change in values from Baseline to 3 months||||<0.0001
72488675|NCT02321930|144505731|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||Analysis performed to test for the change in values from Baseline to 3 months||||<0.0001
72488676|NCT02321930|144505732|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||Analysis performed to test for the change in values from Baseline to 3 months||||<0.0001
72488677|NCT02321930|144505733|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||Analysis performed to test for the change in values from Baseline to 3 months||||<0.0001
72568544|NCT04168190|144668497|OTHER|Estimated difference and CI are calculated based on the Miettinen \& Nurminen method|Difference in Percentage|1.6|||||TWO_SIDED|95.0|-3.8|7.0|||||Phase 2: V116 minus Phase 2: Pneumovax™23|Myalgia||7.0|-3.8|
72488678|NCT02321930|144505734|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||Analysis performed to test for the change in values from Baseline to 3 months||||<0.0001
72488679|NCT01484977|144505737|SUPERIORITY_OR_OTHER||Retention Rate|73.3|||||TWO_SIDED|95.0|65.42|81.25||||||"Analyses of the primary efficacy variable will be descriptive only. No hypothesis tests are planned.~The number and percentage of subjects remaining in the study through the 21-Week Treatment Period will be calculated. Subjects with retention will be counted in the numerator. All subjects in the relevant population will be used as the denominator.~This percentage will be known as the retention rate, along with the 95 % confidence interval based on the normal approximation."||81.25|65.42|
72488680|NCT00853749|144505738|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportions (percentage)|2.7|||||TWO_SIDED|95.0|-5.0|14.2||||||Comparison between treatments for common serotype 4||14.2|-5.0|
72488681|NCT00853749|144505738|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportions (percentage)|0.0|||||TWO_SIDED|95.0|-7.3|9.5||||||Comparison between treatments for common serotype 6B||9.5|-7.3|
72488682|NCT00853749|144505738|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportions (percentage)|0.0|||||TWO_SIDED|95.0|-7.3|9.5||||||Comparison between treatments for common serotype 9V||9.5|-7.3|
72515923|NCT01763866|144562687|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-12.1|STANDARD_ERROR_OF_MEAN|4.83||0.2|TWO_SIDED|95.0|-21.63|-2.58||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-2.58|-21.63|0.20
72488683|NCT00853749|144505738|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportions (percentage)|0.0|||||TWO_SIDED|95.0|-7.8|9.5||||||Comparison between treatments for common serotype 14||9.5|-7.8|
72488684|NCT00853749|144505738|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportions (percentage)|2.7|||||TWO_SIDED|95.0|-5.0|14.2||||||Comparison between treatments for common serotype 18C||14.2|-5.0|
72488685|NCT00853749|144505738|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportions (percentage)|0.0|||||TWO_SIDED|95.0|-7.3|9.5||||||Comparison between treatments for common serotype 19F||9.5|-7.3|
72488686|NCT00853749|144505738|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportions (percentage)|0.0|||||TWO_SIDED|95.0|-7.3|9.5||||||Comparison between treatments for common serotype 23F||9.5|-7.3|
72488687|NCT00853749|144505738|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportions (percentage)|2.7|||||TWO_SIDED|95.0|-5.0|14.2||||||Comparison between treatments for additional serotype 1||14.2|-5.0|
72488688|NCT00853749|144505738|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportions (percentage)|0.0|||||TWO_SIDED|95.0|-7.3|9.5||||||Comparison between treatments for additional serotype 3||9.5|-7.3|
72515924|NCT01763866|144562687|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-22.55|STANDARD_ERROR_OF_MEAN|5.36||0.003|TWO_SIDED|95.0|-33.13|-11.97||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-11.97|-33.13|0.003
72568545|NCT04168190|144668497|OTHER|Estimated difference and CI are calculated based on the Miettinen \& Nurminen method|Difference in Percentage|3.5|||||TWO_SIDED|95.0|-2.7|9.9|||||Phase 2: V116 minus Phase 2: Pneumovax™23|Headache||9.9|-2.7|
72488689|NCT00853749|144505738|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportions (percentage)|0.0|||||TWO_SIDED|95.0|-7.3|9.5||||||Comparison between treatments for additional serotype 5||9.5|-7.3|
72488690|NCT00853749|144505738|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportions (percentage)|0.0|||||TWO_SIDED|95.0|-7.3|9.5||||||Comparison between treatments for additional serotype 6A||9.5|-7.3|
72488691|NCT00853749|144505738|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportions (percentage)|0.0|||||TWO_SIDED|95.0|-7.3|9.5||||||Comparison between treatments for additional serotype 7F||9.5|-7.3|
72488692|NCT00853749|144505738|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportions (percentage)|0.0|||||TWO_SIDED|95.0|-7.3|9.5||||||Comparison between treatments for additional serotype 19A||9.5|-7.3|
72488693|NCT00853749|144505739|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportions (percentage)|0.8|||||TWO_SIDED|95.0|-8.6|12.7||||||Comparison between treatments for common serotype 4||12.7|-8.6|
72488694|NCT00853749|144505739|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportions (percentage)|0.0|||||TWO_SIDED|95.0|-7.5|9.7||||||Comparison between treatments for common serotype 6B||9.7|-7.5|
72488695|NCT00853749|144505739|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportions (percentage)|0.0|||||TWO_SIDED|95.0|-7.5|9.7||||||Comparison between treatments for common serotype 9V||9.7|-7.5|
72488696|NCT00853749|144505739|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportions (percentage)|0.0|||||TWO_SIDED|95.0|-7.5|9.7||||||Comparison between treatments for common serotype 14||9.7|-7.5|
72488697|NCT00853749|144505739|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportions (percentage)|0.0|||||TWO_SIDED|95.0|-7.4|10.0||||||Comparison between treatments for common serotype 18C||10.0|-7.4|
72488698|NCT00853749|144505739|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportions (percentage)|0.0|||||TWO_SIDED|95.0|-7.5|10.0||||||Comparison between treatments for common serotype 19F||10.0|-7.5|
72488699|NCT00853749|144505739|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportions (percentage)|-2.0|||||TWO_SIDED|95.0|-10.8|8.1||||||Comparison between treatments for common serotype 23F||8.1|-10.8|
72488700|NCT00853749|144505739|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportions (percentage)|2.7|||||TWO_SIDED|95.0|-5.0|14.2||||||Comparison between treatments for additional serotype 1||14.2|-5.0|
72488701|NCT00853749|144505739|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportions (percentage)|-2.0|||||TWO_SIDED|95.0|-11.1|7.9||||||Comparison between treatments for additional serotype 3||7.9|-11.1|
72488702|NCT00853749|144505739|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportions (percentage)|0.7|||||TWO_SIDED|95.0|-8.5|12.2||||||Comparison between treatments for additional serotype 5||12.2|-8.5|
72488703|NCT00853749|144505739|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportions (percentage)|0.0|||||TWO_SIDED|95.0|-7.3|9.5||||||Comparison between treatments for additional serotype 6A||9.5|-7.3|
72488704|NCT00853749|144505739|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportions (percentage)|-2.0|||||TWO_SIDED|95.0|-11.3|7.7||||||Comparison between treatments for additional serotype 7F||7.7|-11.3|
72488705|NCT00853749|144505739|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportions (percentage)|0.0|||||TWO_SIDED|95.0|-7.3|9.5||||||Comparison between treatments for additional serotype 19A||9.5|-7.3|
72488706|NCT00853749|144505740|SUPERIORITY_OR_OTHER_LEGACY||Ratio of geometric means|0.3|||||TWO_SIDED|95.0|0.22|0.42|||||CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).|Serotype 1: Ratio of geometric mean avidity (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).||0.42|0.22|
72488707|NCT00853749|144505740|SUPERIORITY_OR_OTHER_LEGACY||Ratio of geometric means|0.32|||||TWO_SIDED|95.0|0.23|0.44|||||CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures ((PCV/23vPS/13vPnC, PCV/PCV/13vPnC).|Serotype 5: Ratio of geometric mean avidity (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).||0.44|0.23|
72488708|NCT00853749|144505740|SUPERIORITY_OR_OTHER_LEGACY||Ratio of geometric means|0.44|||||TWO_SIDED|95.0|0.29|0.67|||||CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).|Serotype 6B: Ratio of geometric mean avidity (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).||0.67|0.29|
72488709|NCT00853749|144505740|SUPERIORITY_OR_OTHER_LEGACY||Ratio of geometric means|0.88|||||TWO_SIDED|95.0|0.61|1.27|||||CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).|Serotype 19F: Ratio of geometric mean avidity (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).||1.27|0.61|
72488710|NCT00853749|144505740|SUPERIORITY_OR_OTHER_LEGACY||Ratio of geometric means|0.47|||||TWO_SIDED|95.0|0.34|0.65|||||CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).|Serotype 23F: Ratio of geometric mean avidity (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).||0.65|0.34|
72404083|NCT03373383|144314762|SUPERIORITY||Percent reduction|17.2|||=|0.102|TWO_SIDED|95.0|-3.8|33.9||Adjusted p-values were from the Hochberg step-up procedure within SAS® Proc Multtest to control Type I error.|ANCOVA|||Percent reduction over placebo was calculated as 100\*(1-exp(diff)), where diff was the model estimate of the log ratio between each PSL group and placebo group.||33.9|-3.8|=0.102
72404084|NCT03373383|144314762|SUPERIORITY||Percent reduction|19.1|||=|0.064|TWO_SIDED|95.0|-1.2|35.4||Adjusted p-values were from the Hochberg step-up procedure within SAS® Proc Multtest to control Type I error.|ANCOVA|||Percent reduction over placebo was calculated as 100\*(1-exp(diff)), where diff was the model estimate of the log ratio between each PSL group and placebo group.||35.4|-1.2|=0.064
72404085|NCT03373383|144314762|SUPERIORITY||Percent reduction|19.2|||=|0.063|TWO_SIDED|95.0|-1.2|35.5||Adjusted p-values were from the Hochberg step-up procedure within SAS® Proc Multtest to control Type I error.|ANCOVA|||Percent reduction over placebo was calculated as 100\*(1-exp(diff)), where diff was the model estimate of the log ratio between each PSL group and placebo group.||35.5|-1.2|=0.063
72404086|NCT03373383|144314762|SUPERIORITY||Percent reduction|12.4|||=|0.248|TWO_SIDED|95.0|-9.7|30.1||Adjusted p-values were from the Hochberg step-up procedure within SAS® Proc Multtest to control Type I error.|ANCOVA|||Percent reduction over placebo was calculated as 100\*(1-exp\[diff\]), where diff was the model estimate of the log ratio between each PSL group and placebo group.||30.1|-9.7|=0.248
72515925|NCT01763866|144562687|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-2.45|STANDARD_ERROR_OF_MEAN|4.89||1|TWO_SIDED|95.0|-12.09|7.19||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||7.19|-12.09|1.00
72515926|NCT01763866|144562687|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-14.95|STANDARD_ERROR_OF_MEAN|5.33||0.053|TWO_SIDED|95.0|-25.46|-4.44||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-4.44|-25.46|0.053
72515927|NCT01763866|144562687|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-15.43|STANDARD_ERROR_OF_MEAN|4.89||0.073|TWO_SIDED|95.0|-25.06|-5.79||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-5.79|-25.06|0.073
72404087|NCT03373383|144314763|SUPERIORITY||Odds Ratio (OR)|2.72|||=|0.081|TWO_SIDED|95.0|0.88|8.39||Nominal p-values were not adjusted for multiplicity.|Regression, Logistic|||PSL dose/Placebo was calculated using logistic regression with categorical factors for treatment group, Region (Europe, Non-Europe), Baseline SV2A use (0, 1) and log-transformed Baseline seizure frequency as a continuous covariate.||8.39|0.88|=0.081
72488711|NCT00853749|144505741|SUPERIORITY_OR_OTHER_LEGACY||Ratio of GMTs|0.6|||||TWO_SIDED|95.0|0.35|1.12|||||CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).|Serotype 4: Ratio of GMTs (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).||1.12|0.35|
72488712|NCT00853749|144505741|SUPERIORITY_OR_OTHER_LEGACY||Ratio of GMTs|1.0|||||TWO_SIDED|95.0|0.68|1.38|||||CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).|Serotype 6B: Ratio of GMTs (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).||1.38|0.68|
72488713|NCT00853749|144505741|SUPERIORITY_OR_OTHER_LEGACY||Ratio of GMTs|1.0|||||TWO_SIDED|95.0|0.51|1.81|||||CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).|Serotype 9V: Ratio of GMTs (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).||1.81|0.51|
72488714|NCT00853749|144505741|SUPERIORITY_OR_OTHER_LEGACY||Ratio of GMTs|1.0|||||TWO_SIDED|95.0|0.67|1.48|||||CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).|Serotype 14: Ratio of GMTs (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).||1.48|0.67|
72515928|NCT01763866|144562687|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-14.41|STANDARD_ERROR_OF_MEAN|5.32||0.027|TWO_SIDED|95.0|-24.9|-3.92||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-3.92|-24.90|0.027
72515929|NCT01763866|144562687|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-1.17|STANDARD_ERROR_OF_MEAN|4.8||1|TWO_SIDED|95.0|-10.63|8.3||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||8.30|-10.63|1.00
72515930|NCT01763866|144562687|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-1.51|STANDARD_ERROR_OF_MEAN|5.38||0.63|TWO_SIDED|95.0|-12.12|9.11||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||9.11|-12.12|0.63
72515931|NCT01763866|144562687|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-22.72|STANDARD_ERROR_OF_MEAN|5.15|<|0.001|TWO_SIDED|95.0|-32.9|-12.54||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-12.54|-32.90|<0.001
72515932|NCT01763866|144562687|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-19.52|STANDARD_ERROR_OF_MEAN|5.69||0.007|TWO_SIDED|95.0|-30.76|-8.28||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-8.28|-30.76|0.007
72515933|NCT01763866|144562687|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-17.59|STANDARD_ERROR_OF_MEAN|4.62||0.002|TWO_SIDED|95.0|-26.71|-8.46||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-8.46|-26.71|0.002
72515934|NCT01763866|144562687|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-26.18|STANDARD_ERROR_OF_MEAN|4.85|<|0.001|TWO_SIDED|95.0|-35.76|-16.59||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-16.59|-35.76|<0.001
72515935|NCT01763866|144562687|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-20.97|STANDARD_ERROR_OF_MEAN|5.78|<|0.001|TWO_SIDED|95.0|-32.38|-9.55||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-9.55|-32.38|<0.001
72515936|NCT01763866|144562687|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-29.71|STANDARD_ERROR_OF_MEAN|5.64|<|0.001|TWO_SIDED|95.0|-40.84|-18.57||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit||||-18.57|-40.84|<0.001
72515937|NCT01763866|144562688|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-12.06|STANDARD_ERROR_OF_MEAN|6.41||0.2|TWO_SIDED|95.0|-24.69|0.57||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||0.57|-24.69|0.20
72515938|NCT01763866|144562688|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-27.6|STANDARD_ERROR_OF_MEAN|7.23||0.003|TWO_SIDED|95.0|-41.86|-13.35||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-13.35|-41.86|0.003
72515939|NCT01763866|144562688|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-3.37|STANDARD_ERROR_OF_MEAN|6.49||1|TWO_SIDED|95.0|-16.16|9.43||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||9.43|-16.16|1.00
72515940|NCT01763866|144562688|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-18.13|STANDARD_ERROR_OF_MEAN|7.18||0.053|TWO_SIDED|95.0|-32.28|-3.99||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-3.99|-32.28|0.053
72568546|NCT04168190|144668498|OTHER|Estimated difference and CI are calculated based on the Miettinen \& Nurminen method|Difference in Percentage|0.0|||||TWO_SIDED|95.0|-1.5|1.5|||||Phase 2: V116 minus Phase 2: Pneumovax™23|||1.5|-1.5|
72568547|NCT04168190|144668499|NON_INFERIORITY|Non-inferiority can be concluded if the lower bound of the 95% CI for the estimated GMT ratio (V116/PPSV23) is \>0.33 (1-sided p-value \<0.025).|GMT Ratio|1.0|||<|0.001|TWO_SIDED|95.0|0.82|1.22|||P-value is estimated from a cLDA model.||Phase 2: V116/Phase 2: Pneumovax™23|Serotype 3. Geometric mean titer (GMT) ratio and 95% confidence interval (CI), and p-value are estimated from a constrained longitudinal data analysis (cLDA) model.||1.22|0.82|<0.001
72568548|NCT04168190|144668499|NON_INFERIORITY|Non-inferiority can be concluded if the lower bound of the 95% CI for the estimated GMT ratio (V116/PPSV23) is \>0.33 (1-sided p-value \<0.025).|GMT Ratio|1.22|||<|0.001|TWO_SIDED|95.0|0.95|1.56|||P-value is estimated from a cLDA model.||Phase 2: V116/Phase 2: Pneumovax™23|Serotype 7F. Geometric mean titer (GMT) ratio and 95% confidence interval (CI), and p-value are estimated from a constrained longitudinal data analysis (cLDA) model.||1.56|0.95|<0.001
72515941|NCT01763866|144562688|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-16.72|STANDARD_ERROR_OF_MEAN|5.39||0.073|TWO_SIDED|95.0|-27.34|-6.1||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-6.10|-27.34|0.073
72488715|NCT00853749|144505741|SUPERIORITY_OR_OTHER_LEGACY||Ratio of GMTs|0.6|||||TWO_SIDED|95.0|0.33|0.98|||||CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures(PCV/23vPS/13vPnC, PCV/PCV/13vPnC).|Serotype 18C: Ratio of GMTs (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).||0.98|0.33|
72488716|NCT00853749|144505741|SUPERIORITY_OR_OTHER_LEGACY||Ratio of GMTs|1.1|||||TWO_SIDED|95.0|0.72|1.56|||||CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).|Serotype 19F: Ratio of GMTs (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).||1.56|0.72|
72488717|NCT00853749|144505741|SUPERIORITY_OR_OTHER_LEGACY||Ratio of GMTs|0.6|||||TWO_SIDED|95.0|0.39|0.99|||||CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).|Serotype 23F: Ratio of GMTs (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).||0.99|0.39|
72488718|NCT00853749|144505741|SUPERIORITY_OR_OTHER_LEGACY||Ratio of GMTs|0.2|||||TWO_SIDED|95.0|0.12|0.32|||||CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).|Serotype 1: Ratio of GMTs (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).||0.32|0.12|
72488719|NCT00853749|144505741|SUPERIORITY_OR_OTHER_LEGACY||Ratio of GMTs|0.8|||||TWO_SIDED|95.0|0.56|1.18|||||CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).|Serotype 3: Ratio of GMTs (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).||1.18|0.56|
72488720|NCT00853749|144505741|SUPERIORITY_OR_OTHER_LEGACY||Ratio of GMTs|0.4|||||TWO_SIDED|95.0|0.21|0.63|||||CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).|Serotype 5: Ratio of GMTs (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).||0.63|0.21|
72488721|NCT00853749|144505741|SUPERIORITY_OR_OTHER_LEGACY||Ratio of GMTs|1.4|||||TWO_SIDED|95.0|0.88|2.25|||||CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).|Serotype 6A: Ratio of GMTs (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).||2.25|0.88|
72488722|NCT00853749|144505741|SUPERIORITY_OR_OTHER_LEGACY||Ratio of GMTs|0.7|||||TWO_SIDED|95.0|0.48|1.14|||||CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).|Serotype 7F: Ratio of GMTs (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).||1.14|0.48|
72488723|NCT00853749|144505741|SUPERIORITY_OR_OTHER_LEGACY||Ratio of GMTs|0.8|||||TWO_SIDED|95.0|0.54|1.2|||||CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).|Serotype 19A: Ratio of GMTs (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).||1.20|0.54|
72488724|NCT00853749|144505742|SUPERIORITY_OR_OTHER_LEGACY||Ratio of GMCs|0.37|||||TWO_SIDED|95.0|0.25|0.55|||||CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).|Serotype 4: Ratio of GMCs (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).||0.55|0.25|
72515942|NCT01763866|144562688|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-9.31|STANDARD_ERROR_OF_MEAN|6.39||0.027|TWO_SIDED|95.0|-21.92|3.29||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||3.29|-21.92|0.027
72515943|NCT01763866|144562688|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-2.67|STANDARD_ERROR_OF_MEAN|5.27||1|TWO_SIDED|95.0|-13.05|7.72||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||7.72|-13.05|1.00
72515944|NCT01763866|144562688|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|2.02|STANDARD_ERROR_OF_MEAN|6.43||0.63|TWO_SIDED|95.0|-10.66|14.69||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||14.69|-10.66|0.63
72488725|NCT00853749|144505742|SUPERIORITY_OR_OTHER_LEGACY||Ratio of GMCs|0.71|||||TWO_SIDED|95.0|0.44|1.15|||||CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).|Serotype 6B: Ratio of GMCs (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).||1.15|0.44|
72488726|NCT00853749|144505742|SUPERIORITY_OR_OTHER_LEGACY||Ratio of GMCs|0.58|||||TWO_SIDED|95.0|0.45|0.75|||||CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).|Serotype 9V: Ratio of GMCs (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).||0.75|0.45|
72488727|NCT00853749|144505742|SUPERIORITY_OR_OTHER_LEGACY||Ratio of GMCs|0.77|||||TWO_SIDED|95.0|0.48|1.24|||||CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).|Serotype 14: Ratio of GMCs (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).||1.24|0.48|
72488728|NCT00853749|144505742|SUPERIORITY_OR_OTHER_LEGACY||Ratio of GMCs|0.57|||||TWO_SIDED|95.0|0.38|0.85|||||CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).|Serotype 18C: Ratio of GMCs (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).||0.85|0.38|
72515945|NCT01763866|144562688|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-18.03|STANDARD_ERROR_OF_MEAN|7.08|<|0.001|TWO_SIDED|95.0|-32.03|-4.04||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-4.04|-32.03|<0.001
72404088|NCT03373383|144314763|SUPERIORITY||Odds Ratio (OR)|2.37|||=|0.137|TWO_SIDED|95.0|0.76|7.41||Nominal p-values were not adjusted for multiplicity.|Regression, Logistic|||PSL dose/Placebo was calculated using logistic regression with categorical factors for treatment group, Region (Europe, Non-Europe), Baseline SV2A use (0, 1) and log-transformed Baseline seizure frequency as a continuous covariate.||7.41|0.76|=0.137
72488729|NCT00853749|144505742|SUPERIORITY_OR_OTHER_LEGACY||Ratio of GMCs|0.84|||||TWO_SIDED|95.0|0.56|1.27|||||CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).|Serotype 19F: Ratio of GMCs (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).||1.27|0.56|
72488730|NCT00853749|144505742|SUPERIORITY_OR_OTHER_LEGACY||Ratio of GMCs|0.64|||||TWO_SIDED|95.0|0.44|0.95|||||CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).|Serotype 23F: Ratio of GMCs (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).||0.95|0.44|
72488731|NCT00853749|144505742|SUPERIORITY_OR_OTHER_LEGACY||Ratio of GMCs|0.27|||||TWO_SIDED|95.0|0.18|0.4|||||CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).|Serotype 1: Ratio of GMCs (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).||0.40|0.18|
72488732|NCT00853749|144505742|SUPERIORITY_OR_OTHER_LEGACY||Ratio of GMCs|1.14|||||TWO_SIDED|95.0|0.76|1.72|||||CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).|Serotype 3: Ratio of GMCs (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).||1.72|0.76|
72488733|NCT00853749|144505742|SUPERIORITY_OR_OTHER_LEGACY||Ratio of GMCs|0.36|||||TWO_SIDED|95.0|0.25|0.51|||||CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).|Serotype 5: Ratio of GMCs (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).||0.51|0.25|
72488734|NCT00853749|144505742|SUPERIORITY_OR_OTHER_LEGACY||Ratio of GMCs|0.79|||||TWO_SIDED|95.0|0.55|1.14|||||CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).|Serotype 6A: Ratio of GMCs (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).||1.14|0.55|
72488735|NCT00853749|144505742|SUPERIORITY_OR_OTHER_LEGACY||Ratio of GMCs|0.89|||||TWO_SIDED|95.0|0.61|1.28|||||CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).|Serotype 7F: Ratio of GMCs (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).||1.28|0.61|
72488736|NCT00853749|144505742|SUPERIORITY_OR_OTHER_LEGACY||Ratio of GMCs|0.86|||||TWO_SIDED|95.0|0.6|1.23|||||CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).|Serotype 19A: Ratio of GMCs (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).||1.23|0.60|
72488737|NCT00853749|144505743|SUPERIORITY_OR_OTHER_LEGACY|||||||0.253|TWO_SIDED||||||Fisher Exact|||Comparison between treatments for any tenderness||||0.253
72488738|NCT00853749|144505743|SUPERIORITY_OR_OTHER_LEGACY|||||||0.38|TWO_SIDED||||||Fisher Exact|||Comparison between treatments for significant tenderness||||0.380
72488739|NCT00853749|144505743|SUPERIORITY_OR_OTHER_LEGACY|||||||0.135|TWO_SIDED||||||Fisher Exact|||Comparison between treatments for any redness||||0.135
72515946|NCT01763866|144562688|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-19.83|STANDARD_ERROR_OF_MEAN|6.52||0.007|TWO_SIDED|95.0|-32.71|-6.96||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-6.96|-32.71|0.007
72515947|NCT01763866|144562688|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-16.55|STANDARD_ERROR_OF_MEAN|5.71||0.002|TWO_SIDED|95.0|-27.84|-5.26||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-5.26|-27.84|0.002
72404089|NCT03373383|144314763|SUPERIORITY||Odds Ratio (OR)|2.16|||=|0.192|TWO_SIDED|95.0|0.68|6.89||Nominal p-values were not adjusted for multiplicity.|Regression, Logistic|||PSL dose/Placebo was calculated using logistic regression with categorical factors for treatment group, Region (Europe, Non-Europe), Baseline SV2A use (0, 1) and log-transformed Baseline seizure frequency as a continuous covariate.||6.89|0.68|=0.192
72488740|NCT00853749|144505743|SUPERIORITY_OR_OTHER_LEGACY|||||||0.52|TWO_SIDED||||||Fisher Exact|||Comparison between treatments for mild redness||||0.520
72488741|NCT00853749|144505743|SUPERIORITY_OR_OTHER_LEGACY|||||||0.283|TWO_SIDED||||||Fisher Exact|||Comparison between treatments for moderate redness||||0.283
72488742|NCT00853749|144505743|SUPERIORITY_OR_OTHER_LEGACY|||||||0.225|TWO_SIDED||||||Fisher Exact|||Comparison between treatments for severe redness||||0.225
72488743|NCT00853749|144505743|SUPERIORITY_OR_OTHER_LEGACY|||||||0.202|TWO_SIDED||||||Fisher Exact|||Comparison between treatments for any swelling||||0.202
72488744|NCT00853749|144505743|SUPERIORITY_OR_OTHER_LEGACY|||||||0.294|TWO_SIDED||||||Fisher Exact|||Comparison between treatments for mild swelling||||0.294
72488745|NCT00853749|144505743|SUPERIORITY_OR_OTHER_LEGACY|||||||0.175|TWO_SIDED||||||Fisher Exact|||Comparison between treatments for moderate swelling||||0.175
72488746|NCT00853749|144505743|SUPERIORITY_OR_OTHER_LEGACY|||||||0.314|TWO_SIDED||||||Fisher Exact|||Comparison between treatments for severe swelling||||0.314
72488747|NCT00853749|144505744|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.99|TWO_SIDED||||||Fisher Exact|||Comparison between treatments for fever ≥ 38 degrees C but ≤ 39 degrees C||||> .99
72488748|NCT00853749|144505744|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.99|TWO_SIDED||||||Fisher Exact|||Comparison between treatments for decreased appetite||||> .99
72488749|NCT00853749|144505744|SUPERIORITY_OR_OTHER_LEGACY|||||||0.543|TWO_SIDED||||||Fisher Exact|||Comparison between treatments for irritability||||0.543
72488750|NCT00853749|144505744|SUPERIORITY_OR_OTHER_LEGACY|||||||0.233|TWO_SIDED||||||Fisher Exact|||Comparison between treatments for increased sleep||||0.233
72488751|NCT00853749|144505744|SUPERIORITY_OR_OTHER_LEGACY|||||||0.198|TWO_SIDED||||||Fisher Exact|||Comparison between treatments for decreased sleep||||0.198
72488752|NCT00853749|144505744|SUPERIORITY_OR_OTHER_LEGACY|||||||0.628|TWO_SIDED||||||Fisher Exact|||Comparison between treatments for rash||||0.628
72488753|NCT00255970|144505757|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||This study had been designed as a superiority study. The null hypothesis had been that there would be no significant difference in probing depth between groups at the time points measured.||||>.05
72488754|NCT00255970|144505757|SUPERIORITY_OR_OTHER||||||>|0.05||||||The power analysis had been computed for a threshold of 0.05 with a power of 0.8.|ANOVA|||A power analysis, prior to data collection, determined that a minimum of 18 in each arm would be needed for this study.||||>0.05
72488755|NCT00255970|144505758|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||ANOVA|||This study had been designed as a superiority study. The a priori power analysis had been designed with an effect size based on historical data. Thus, a minimal sample size of 34 patients would be necessary to determine if there was a true difference between groups, α =.05, power= 0.8. This number was then rounded to 40 patients, 20/ group (DFDBA and Regenafil).||||>.05
72515948|NCT01763866|144562688|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-20.51|STANDARD_ERROR_OF_MEAN|5.33|<|0.001|TWO_SIDED|95.0|-31.04|-9.98||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-9.98|-31.04|<0.001
72515949|NCT01763866|144562688|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-21.78|STANDARD_ERROR_OF_MEAN|5.62|<|0.001|TWO_SIDED|95.0|-32.88|-10.68||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-10.68|-32.88|<0.001
72515950|NCT01763866|144562688|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-31.36|STANDARD_ERROR_OF_MEAN|6.45|<|0.001|TWO_SIDED|95.0|-44.1|-18.62||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit||||-18.62|-44.10|<0.001
72568549|NCT04168190|144668499|NON_INFERIORITY|Non-inferiority can be concluded if the lower bound of the 95% CI for the estimated GMT ratio (V116/PPSV23) is \>0.33 (1-sided p-value \<0.025).|GMT Ratio|1.13|||<|0.001|TWO_SIDED|95.0|0.9|1.41|||P-value is estimated from a cLDA model.||Phase 2: V116/Phase 2: Pneumovax™23|Serotype 19A. Geometric mean titer (GMT) ratio and 95% confidence interval (CI), and p-value are estimated from a constrained longitudinal data analysis (cLDA) model.||1.41|0.90|<0.001
72488756|NCT00255970|144505759|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||The change in recession, measured in mm, had been designed as a superiority study. The a priori power analysis had been designed with an effect size based on historical data. Thus, a minimal sample size of 34 patients would be necessary to determine if there was a true difference between groups, α =.05, power= 0.8. This number was then rounded to 40 patients, 20/ group (DFDBA and Regenafil).||||>0.05
72488757|NCT00255970|144505760|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||ANOVA|||Each gingival unit (buccal, lingual, mesiobuccal, distobuccal, mesiolingual, and distolingual) of the individual tooth will be given a score from 0-3, called the gingival index for the area. The scores from the 6 areas of the tooth are added and divided by 6 to give the gingival index for the tooth.||||>0.05
72515951|NCT01763866|144562689|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-13.36|STANDARD_ERROR_OF_MEAN|4.38||0.088|TWO_SIDED|95.0|-21.99|-4.74||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-4.74|-21.99|0.088
72568550|NCT04168190|144668499|NON_INFERIORITY|Non-inferiority can be concluded if the lower bound of the 95% CI for the estimated GMT ratio (V116/PPSV23) is \>0.33 (1-sided p-value \<0.025).|GMT Ratio|1.58|||<|0.001|TWO_SIDED|95.0|1.16|2.16|||P-value is estimated from a cLDA model.||Phase 2: V116/Phase 2: Pneumovax™23|Serotype 22F. Geometric mean titer (GMT) ratio and 95% confidence interval (CI), and p-value are estimated from a constrained longitudinal data analysis (cLDA) model.||2.16|1.16|<0.001
72488758|NCT00255970|144505761|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||ANOVA|||This study had been designed as a superiority study. The a priori power analysis had been designed with an effect size based on historical data. Thus, a minimal sample size of 34 patients would be necessary to determine if there was a true difference between groups, α =.05, power= 0.8. This number was then rounded to 40 patients, 20/ group (DFDBA and Regenafil).||||>0.05
72488759|NCT01392677|144505764|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.69|STANDARD_ERROR_OF_MEAN|0.1022|<|0.0001|TWO_SIDED|95.0|-0.89|-0.49||Significant at alpha=0.05 (2-sided). A hierarchical closed testing procedure was used to control Type I error across the primary \& key secondary objectives|Mixed Models Analysis|Longitudinal repeated measures model using mixed model with treatment group, baseline value, week and week\*treatment and week\*baseline||H0: mean(treat) minus mean(placebo) = 0 versus the alternative HA: mean(treat) minus mean(placebo) =/= 0||-0.49|-0.89|<0.0001
72568551|NCT04168190|144668499|NON_INFERIORITY|Non-inferiority can be concluded if the lower bound of the 95% CI for the estimated GMT ratio (V116/PPSV23) is \>0.33 (1-sided p-value \<0.025).|GMT Ratio|0.94|||<|0.001|TWO_SIDED|95.0|0.71|1.24|||P-value is estimated from a cLDA model.||Phase 2: V116/Phase 2: Pneumovax™23|Serotype 33F. Geometric mean titer (GMT) ratio and 95% confidence interval (CI), and p-value are estimated from a constrained longitudinal data analysis (cLDA) model.||1.24|0.71|<0.001
72488760|NCT01392677|144505765|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-33.45|STANDARD_ERROR_OF_MEAN|4.8846|<|0.0001|TWO_SIDED|95.0|-43.08|-23.82||Significant at alpha=0.05 (2-sided). A hierarchical closed testing procedure was used to control Type I error across the primary \& key secondary objectives|ANCOVA|with treatment group as effect and baseline value as covariate||H0: mean(treat) minus mean(placebo) = 0 versus the alternative HA: mean(treat) minus mean(placebo) =/= 0||-23.82|-43.08|<0.0001
72404090|NCT03373383|144314763|SUPERIORITY||Odds Ratio (OR)|3.14|||=|0.041|TWO_SIDED|95.0|1.05|9.42||Nominal p-values were not adjusted for multiplicity.|Regression, Logistic|||PSL dose/Placebo was calculated using logistic regression with categorical factors for treatment group, Region (Europe, Non-Europe), Baseline SV2A use (0, 1) and log-transformed Baseline seizure frequency as a continuous covariate.||9.42|1.05|=0.041
72404091|NCT03373383|144314767|SUPERIORITY||Odds Ratio (OR)|2.09|||=|0.045|TWO_SIDED|95.0|1.02|4.3||Nominal p-values were not adjusted for multiplicity.|Regression, Logistic|||PSL dose/placebo calculated using logistic regression with categorical factors for treatment group (each PSL dose group referenced to the placebo group), region (Europe, Non-Europe), Baseline SV2A use (0, 1) and log-transformed Baseline seizure frequency as a continuous covariate.||4.30|1.02|=0.045
72488761|NCT01392677|144505766|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.07|STANDARD_ERROR_OF_MEAN|0.3651|<|0.0001|TWO_SIDED|95.0|-2.79|-1.35||Significant at alpha=0.05 (2-sided). A hierarchical closed testing procedure was used to control Type I error across the primary \& key secondary objectives|ANCOVA|with treatment group as effect and baseline value as covariate||H0: mean(treat) minus mean(placebo) = 0 versus the alternative HA: mean(treat) minus mean(placebo) =/= 0||-1.35|-2.79|<0.0001
72488762|NCT01392677|144505767|SUPERIORITY_OR_OTHER||Risk Difference (RD)|20.7|STANDARD_ERROR_OF_MEAN|5.056|<|0.0001|TWO_SIDED|95.0|10.7|30.6||Significant at alpha=0.05 (2-sided). A hierarchical closed testing procedure was used to control Type I error across the primary \& key secondary objectives|Regression, Logistic|Based on methodology of Zhang, Tsiatis \& Davidian and Tsiatis, Davidian, Zhang \& Lu, with adjustment for baseline value||H0: proportion(treat) minus proportion (placebo) = 0 versus the alternative HA: proportion (treat) minus proportion (placebo) =/= 0||30.6|10.7|<0.0001
72488763|NCT01392677|144505768|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.76|STANDARD_ERROR_OF_MEAN|1.6677||0.025|TWO_SIDED|95.0|-7.05|-0.48||Significant at alpha=0.05 (2-sided). A hierarchical closed testing procedure was used to control Type I error across the primary \& key secondary objectives|ANCOVA|with treatment group as effect and baseline value as covariate||H0: mean(treat) minus mean(placebo) = 0 versus the alternative HA: mean(treat) minus mean(placebo) =/= 0||-0.48|-7.05|0.025
72488764|NCT03996876|144505769|SUPERIORITY|Given the relatively small sample size, results of our inferential statistical tests should be interpreted with caution.|F Statistic|1.032||||0.322|TWO_SIDED|||||The a priori threshold for statistical significance was set at 0.05.|ANOVA|We conducted a two-way mixed ANOVA with intervention as the between-subjects and time as the within-subjects variable.|The F Statistic reported is for the interaction between Intervention and Time.|||||0.322
72488765|NCT02726971|144505772|SUPERIORITY_OR_OTHER||||||>|0.05|||||||t-test, 2 sided|||||||>0.05
72488766|NCT03080883|144505775|SUPERIORITY||Hazard Ratio (HR)|0.72||||0.3117|TWO_SIDED|95.0|0.38|1.37|||Gray Test P-value|||||1.37|0.38|0.3117
72488767|NCT03080883|144505776|SUPERIORITY||Hazard Ratio (HR)|1.0||||0.997|TWO_SIDED|95.0|0.4|2.53|||Gray Test P-value|||||2.53|0.40|0.9970
72488768|NCT04360551|144505795|SUPERIORITY|||||||0.244|||||||Wilcoxon (Mann-Whitney)|||||||0.244
72488769|NCT04360551|144505796|SUPERIORITY||||||>|0.5|||||||Kruskal-Wallis|||||||>0.5
72488770|NCT01761292|144505844|OTHER||mean|13.906|||<|0.0001|TWO_SIDED|95.0|11.5657|16.2466||The paired t-test or non-parametric signed rank test for 2 means (paired observations) (as is appropriate) was applied for testing the statistical significance of the Change From Baseline to End of Study. MFA% P \< 0.05 was set as significant.|t-test, 2 sided|||||16.2466|11.5657|<0.0001
72488771|NCT01761292|144505845|OTHER||||||<|0.0001|||||||t-test, 2 sided|||||||< 0.0001
72488772|NCT04036708|144505859|SUPERIORITY|The key parameter was the coefficient for the trial arm difference at month 6 in linear mixed effects model.|Mean Difference (Final Values)|0.69|STANDARD_ERROR_OF_MEAN|2.33||0.77|TWO_SIDED|95.0|-3.93|5.32||P-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was .05.|Mixed Models Analysis|Baseline value of the outcome, household material possessions, and the HOME score were adjusted for in the model.|WTM only minus MISC and WTM|The null hypothesis was that the means of two groups were equal. The alternative hypothesis was that the means of two groups were not equal. Planned sample size of total 100 analyzed was determined by feasibility considerations for this exploratory developmental R21 study. With planned n=66 in MISC+WTM arm and n=34 in WTM only arm, the unadjusted effect size of 0.60 was detectable as statistically significant with power of 0.80 and 0.05 level of significance in two-tailed tests.||5.32|-3.93|.77
72515952|NCT01763866|144562689|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-21.31|STANDARD_ERROR_OF_MEAN|5.41||0.005|TWO_SIDED|95.0|-31.98|-10.64||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-10.64|-31.98|0.005
72515953|NCT01763866|144562689|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-1.5|STANDARD_ERROR_OF_MEAN|4.45||1|TWO_SIDED|95.0|-10.27|7.27||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||7.27|-10.27|1.00
72568552|NCT04168190|144668499|NON_INFERIORITY|Non-inferiority can be concluded if the lower bound of the 95% CI for the estimated GMT ratio (V116/PPSV23) is \>0.33 (1-sided p-value \<0.025).|GMT Ratio|0.99|||<|0.001|TWO_SIDED|95.0|0.8|1.21|||P-value is estimated from a cLDA model.||Phase 2: V116/Phase 2: Pneumovax™23|Serotype 8. Geometric mean titer (GMT) ratio and 95% confidence interval (CI), and p-value are estimated from a constrained longitudinal data analysis (cLDA) model.||1.21|0.80|<0.001
72568553|NCT04168190|144668499|NON_INFERIORITY|Non-inferiority can be concluded if the lower bound of the 95% CI for the estimated GMT ratio (V116/PPSV23) is \>0.33 (1-sided p-value \<0.025).|GMT Ratio|1.13|||<|0.001|TWO_SIDED|95.0|0.87|1.47|||P-value is estimated from a cLDA model.||Phase 2: V116/Phase 2: Pneumovax™23|Serotype 9N. Geometric mean titer (GMT) ratio and 95% confidence interval (CI), and p-value are estimated from a constrained longitudinal data analysis (cLDA) model.||1.47|0.87|<0.001
72624319|NCT00863304|144778629|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.27|STANDARD_ERROR_OF_MEAN|0.23|<|0.001|TWO_SIDED|95.0|-1.73|-0.82||P-value was based on pairwise comparisons.|ANCOVA|||Week 4: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.82|-1.73|<0.001
72488773|NCT04036708|144505859|SUPERIORITY|The key parameter was the coefficient for the trial arm difference at month 12 in linear mixed effects model.|Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|2.44||0.9|TWO_SIDED|95.0|-5.14|4.54||P-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was .05.|Mixed Models Analysis|Baseline value of the outcome, household material possessions, and the HOME score were adjusted for in the model.|WTM only minus MISC and WTM|The null hypothesis was that the means of two groups were equal. The alternative hypothesis was that the means of two groups were not equal. Planned sample size of total 100 analyzed was determined by feasibility considerations for this exploratory developmental R21 study. With planned n=66 in MISC+WTM arm and n=34 in WTM only arm, the unadjusted effect size of 0.60 was detectable as statistically significant with power of 0.80 and 0.05 level of significance in two-tailed tests.||4.54|-5.14|.90
72488774|NCT04036708|144505860|SUPERIORITY|The key parameter was the coefficient for the trial arm difference at month 6 in linear mixed effects model.|Mean Difference (Final Values)|64.03|STANDARD_ERROR_OF_MEAN|24.55||0.01|TWO_SIDED|95.0|15.26|112.8||P-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was .05.|Mixed Models Analysis|Baseline value of the outcome, household material possessions, the HOME score, child's age and sex were adjusted for in the model.|WTM only minus MISC and WTM|The null hypothesis was that the means of two groups were equal. The alternative hypothesis was that the means of two groups were not equal. Planned sample size of total 100 analyzed was determined by feasibility considerations for this exploratory developmental R21 study. With planned n=66 in MISC+WTM arm and n=34 in WTM only arm, the unadjusted effect size of 0.60 was detectable as statistically significant with power of 0.80 and 0.05 level of significance in two-tailed tests.||112.8|15.26|.01
72488775|NCT04036708|144505860|SUPERIORITY|The key parameter was the coefficient for the trial arm difference at month 12 in linear mixed effects model.|Mean Difference (Final Values)|-37.53|STANDARD_ERROR_OF_MEAN|24.86||0.13|TWO_SIDED|95.0|-86.92|11.85||P-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was .05.|Mixed Models Analysis|Baseline value of the outcome, household material possessions, the HOME score, and child's age and sex were adjusted for in the model.|WTM only minus MISC and WTM|The null hypothesis was that the means of two groups were equal. The alternative hypothesis was that the means of two groups were not equal. Planned sample size of total 100 analyzed was determined by feasibility considerations for this exploratory developmental R21 study. With planned n=66 in MISC+WTM arm and n=34 in WTM only arm, the unadjusted effect size of 0.60 was detectable as statistically significant with power of 0.80 and 0.05 level of significance in two-tailed tests.||11.85|-86.92|.13
72488776|NCT04036708|144505861|SUPERIORITY|The key parameter was the coefficient for the trial arm difference at month 6 in linear mixed effects model.|Mean Difference (Final Values)|-1.76|STANDARD_ERROR_OF_MEAN|2.97||0.55|TWO_SIDED|95.0|-7.65|4.13||P-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was .05.|Mixed Models Analysis|Baseline value of the outcome and household material possessions were adjusted for in the model.|WTM only minus MISC and WTM|The null hypothesis was that the means of two groups were equal. Sample size was determined by considerations for the primary outcomes.||4.13|-7.65|.55
72488777|NCT04036708|144505861|SUPERIORITY|The key parameter was the coefficient for the trial arm difference at month 12 in linear mixed effects model.|Mean Difference (Final Values)|-3.42|STANDARD_ERROR_OF_MEAN|3.05||0.26|TWO_SIDED|95.0|-9.48|2.63||P-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was .05.|Mixed Models Analysis|Baseline value of the outcome and household material possessions were adjusted for in the model.|WTM only minus MISC and WTM|The null hypothesis was that the means of two groups were equal. Sample size was determined by considerations for the primary outcomes.||2.63|-9.48|.26
72488778|NCT04036708|144505862|SUPERIORITY|The key parameter was the coefficient for the trial arm difference at month 6 in linear mixed effects model.|Mean Difference (Final Values)|-0.16|STANDARD_ERROR_OF_MEAN|0.16||0.32|TWO_SIDED|95.0|-0.48|0.16||P-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was .05.|Mixed Models Analysis|Baseline value of the outcome, household material possessions, and the HOME score were adjusted for in the model.|WTM only minus MISC and WTM|The null hypothesis was that the means of two groups were equal. Sample size was determined by considerations for the primary outcomes.||0.16|-0.48|.32
72404092|NCT03373383|144314767|SUPERIORITY||Odds Ratio (OR)|1.91|||=|0.079|TWO_SIDED|95.0|0.93|3.93||Nominal p-values were not adjusted for multiplicity.|Regression, Logistic|||PSL dose/placebo calculated using logistic regression with categorical factors for treatment group (each PSL dose group referenced to the placebo group), region (Europe, Non-Europe), Baseline SV2A use (0, 1) and log-transformed Baseline seizure frequency as a continuous covariate.||3.93|0.93|=0.079
72488779|NCT04036708|144505862|SUPERIORITY|The key parameter was the coefficient for the trial arm difference at month 12 in linear mixed effects model.|Mean Difference (Final Values)|-0.39|STANDARD_ERROR_OF_MEAN|0.16||0.02|TWO_SIDED|95.0|-0.72|-0.06||P-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was .05.|Mixed Models Analysis|Baseline value of the outcome, household material possessions, and the HOME score were adjusted for in the model.|WTM only minus MISC and WTM|The null hypothesis was that the means of two groups were equal. Sample size was determined by considerations for the primary outcomes.||-0.06|-0.72|.02
72515954|NCT01763866|144562689|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-13.54|STANDARD_ERROR_OF_MEAN|5.39||0.056|TWO_SIDED|95.0|-24.17|-2.91||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-2.91|-24.17|0.056
72515955|NCT01763866|144562689|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-15.21|STANDARD_ERROR_OF_MEAN|4.91||0.073|TWO_SIDED|95.0|-24.88|-5.54||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-5.54|-24.88|0.073
72404093|NCT03373383|144314767|SUPERIORITY||Odds Ratio (OR)|1.44|||=|0.338|TWO_SIDED|95.0|0.68|3.02||Nominal p-values were not adjusted for multiplicity.|Regression, Logistic|||PSL dose/placebo calculated using logistic regression with categorical factors for treatment group (each PSL dose group referenced to the placebo group), region (Europe, Non-Europe), Baseline SV2A use (0, 1) and log-transformed Baseline seizure frequency as a continuous covariate.||3.02|0.68|=0.338
72404094|NCT03373383|144314767|SUPERIORITY||Odds Ratio (OR)|1.88|||=|0.087|TWO_SIDED|95.0|0.91|3.87||Nominal p-values were not adjusted for multiplicity.|Regression, Logistic|||PSL dose/Placebo calculated using logistic regression with categorical factors for treatment group, Region (Europe, Non-Europe), Baseline SV2A use (0, 1) and log-transformed Baseline seizure frequency as a continuous covariate.||3.87|0.91|=0.087
72488780|NCT04036708|144505863|SUPERIORITY|The key parameter was the coefficient for the trial arm difference at month 6 in linear mixed effects model.|Mean Difference (Final Values)|-0.38|STANDARD_ERROR_OF_MEAN|0.2||0.06|TWO_SIDED|95.0|-0.78|0.01||P-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was .05.|Mixed Models Analysis|Baseline value of the outcome, household material possessions, and the HOME score were adjusted for in the model.|WTM only minus MISC and WTM|The null hypothesis was that the means of two groups were equal. Sample size was determined by considerations for the primary outcomes.||0.01|-0.78|.06
72488781|NCT04036708|144505863|SUPERIORITY|The key parameter was the coefficient for the trial arm difference at month 12 in linear mixed effects model.|Mean Difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|0.21||0.001|TWO_SIDED|95.0|-1.11|-0.28||P-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was .05.|Mixed Models Analysis|Baseline value of the outcome, household material possessions, and the HOME score were adjusted for in the model.|WTM only minus MISC and WTM|The null hypothesis was that the means of two groups were equal. Sample size was determined by considerations for the primary outcomes.||-0.28|-1.11|.001
72488782|NCT04036708|144505864|SUPERIORITY|The key parameter was the coefficient for the trial arm difference at month 6 in linear mixed effects model.|Mean Difference (Final Values)|1.05|STANDARD_ERROR_OF_MEAN|0.49||0.04|TWO_SIDED|95.0|0.07|2.03||P-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was .05.|Mixed Models Analysis|Baseline value of the outcome, household material possessions, and the HOME score were adjusted for in the model.|WTM only minus MISC and WTM|The null hypothesis was that the means of two groups were equal. Sample size was determined by considerations for the primary outcomes.||2.03|0.07|.04
72488783|NCT04036708|144505864|SUPERIORITY|The key parameter was the coefficient for the trial arm difference at month 12 in linear mixed effects model.|Mean Difference (Final Values)|0.94|STANDARD_ERROR_OF_MEAN|0.51||0.07|TWO_SIDED|95.0|-0.08|1.96||P-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was .05.|Mixed Models Analysis|Baseline value of the outcome, household material possessions, and the HOME score were adjusted for in the model.|WTM only minus MISC and WTM|The null hypothesis was that the means of two groups were equal. Sample size was determined by considerations for the primary outcomes.||1.96|-0.08|.07
72488784|NCT04036708|144505865|SUPERIORITY|The key parameter was the coefficient for the trial arm difference at month 6 in linear mixed effects model.|Mean Difference (Final Values)|2.04|STANDARD_ERROR_OF_MEAN|0.51|<|0.01|TWO_SIDED|95.0|1.02|3.06||P-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was .05.|Mixed Models Analysis|Baseline value of the outcome, household material possessions, and the HOME score were adjusted for in the model.|WTM only minus MISC and WTM|The null hypothesis was that the means of two groups were equal. Sample size was determined by considerations for the primary outcomes.||3.06|1.02|<.01
72488785|NCT04036708|144505865|SUPERIORITY|The key parameter was the coefficient for the trial arm difference at month 12 in linear mixed effects model.|Mean Difference (Final Values)|1.73|STANDARD_ERROR_OF_MEAN|0.53|<|0.01|TWO_SIDED|95.0|0.67|2.79||P-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was .05.|Mixed Models Analysis|Baseline value of the outcome, household material possessions, and the HOME score were adjusted for in the model.|WTM only minus MISC and WTM|The null hypothesis was that the means of two groups were equal. Sample size was determined by considerations for the primary outcomes.||2.79|0.67|<.01
72515956|NCT01763866|144562689|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-14.69|STANDARD_ERROR_OF_MEAN|5.21||0.027|TWO_SIDED|95.0|-24.97|-4.42||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-4.42|-24.97|0.027
72515957|NCT01763866|144562689|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-0.44|STANDARD_ERROR_OF_MEAN|4.82||1|TWO_SIDED|95.0|-9.94|9.05||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||9.05|-9.94|1.00
72515958|NCT01763866|144562689|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-0.25|STANDARD_ERROR_OF_MEAN|5.28||0.62|TWO_SIDED|95.0|-10.66|10.16||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||10.16|-10.66|0.62
72515959|NCT01763866|144562689|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-25.07|STANDARD_ERROR_OF_MEAN|4.85|<|0.001|TWO_SIDED|95.0|-34.64|-15.5||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-15.50|-34.64|<0.001
72515960|NCT01763866|144562689|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-19.79|STANDARD_ERROR_OF_MEAN|5.58||0.007|TWO_SIDED|95.0|-30.81|-8.77||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-8.77|-30.81|0.007
72624320|NCT00863304|144778629|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.15|STANDARD_ERROR_OF_MEAN|0.23|<|0.001|TWO_SIDED|95.0|-1.61|-0.7||P-value was based on pairwise comparisons.|ANCOVA|||Week 4: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.70|-1.61|<0.001
72488786|NCT02700412|144505885|OTHER|Single group.|||||<|0.0001||||||P-value reported above is the global test for change in seizure frequency over a 12-month period.|Wilcoxon (Mann-Whitney)|Wilcoxon signed rank test with Bonferonni multiple comparison correction was used as a post-hoc analysis to indicate direction of change.||Null hypothesis is that there was no change in seizure frequency between any two assessment time points during this period of analysis. Alternative hypothesis is that there were two or more assessment time points for which change in seizure frequency was different from zero.|Generalized least squares statistical techniques were used for modeling longitudinal data after normality of seizure frequency outcome measures were achieved through log-transformations methods. The following baseline clinical variables were adjusted for: AEDs, AEDs tried, epileptic surgery, and gender. Reported results were geometric least squares mean and its associated 95% Confidence Interval. Percentage reduction in seizure frequency relative to baseline were obtained by subtracting from 1 and then multiplying by 100 at all post-baseline timepoints.|||<0.0001
72488787|NCT02700412|144505886|OTHER|Single group.|||||<|0.0001||||||P-value reported above is the global test for change in seizure severity scores over a 12-month period.|Wilcoxon (Mann-Whitney)|Wilcoxon signed rank test with Bonferonni multiple comparison correction was used as a post-hoc analysis to indicate direction of change.||Null hypothesis is that there was no change in seizure severity scores between any two assessment time points during this period of analysis. Alternative hypothesis is that there were two or more assessment time points for which change in seizure severity scores was different from zero.|Generalized least squares statistical techniques were used for modeling longitudinal data after normality of seizure severity score outcome measures were achieved through log-transformations methods. The following baseline clinical variables were adjusted for: AEDs, AEDs tried, epileptic surgery, and gender. Reported results were geometric least squares mean and its associated 95% Confidence Interval. Percentage reduction in seizure severity relative to baseline were obtained by subtracting from 1 and then multiplying by 100 at all post-baseline timepoints.|||<0.0001
72488788|NCT00632099|144505887|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Fisher Exact|||||||<0.05
72488789|NCT00552175|144505897|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.87|STANDARD_ERROR_OF_MEAN|0.15|<|0.0001|TWO_SIDED|95.0|-1.17|-0.56|||Mixed Models Analysis|Covariates: Baseline value of average pain score, type of Diabetes, Duration of diabetic peripheral neuropathic pain (DPNP).|Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|The primary objective and primary efficacy analysis for the study was the analysis between the combined duloxetine arms and placebo.||-0.56|-1.17|<0.0001
72488790|NCT00552175|144505899|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.96|||<|0.0001|TWO_SIDED|95.0|-1.27|-0.64||P-value for Worst Pain.|Mixed Models Analysis|Covariates: Baseline value of worst pain score, type of Diabetes, Duration of diabetic peripheral neuropathic pain (DPNP).|Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|||-0.64|-1.27|<0.0001
72488791|NCT00552175|144505899|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.83|||<|0.0001|TWO_SIDED|95.0|-1.15|-0.51||P-value for Night Pain.|Mixed Models Analysis|Covariates: Baseline value of night pain score, type of Diabetes, Duration of diabetic peripheral neuropathic pain (DPNP).|Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|||-0.51|-1.15|<0.0001
72488792|NCT00552175|144505900|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.87|||||TWO_SIDED|95.0|-1.26|-0.49|||Mixed Models Analysis|Covariates: Baseline value of worst pain score, type of diabetes, and duration of diabetic peripheral neuropathic pain (DPNP).|Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|Worst Pain analysis||-0.49|-1.26|
72488793|NCT00552175|144505900|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-1.05|||||TWO_SIDED|95.0|-1.43|-0.66|||Mixed Models Analysis|Covariates: Baseline value of worst pain score, type of diabetes, and duration of diabetic peripheral neuropathic pain (DPNP).|Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|Worst Pain analysis||-0.66|-1.43|
72488794|NCT00552175|144505900|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.78|||||TWO_SIDED|95.0|-1.17|-0.39|||Mixed Models Analysis|Covariates: Baseline value of night pain score, type of diabetes, and duration of diabetic peripheral neuropathic pain (DPNP).|Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|Night Pain analysis||-0.39|-1.17|
72488795|NCT00552175|144505900|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.89|||||TWO_SIDED|95.0|-1.28|-0.5|||Mixed Models Analysis|Covariates: Baseline value of night pain score, type of diabetes, and duration of diabetic peripheral neuropathic pain (DPNP).|Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|Night Pain analysis||-0.5|-1.28|
72488796|NCT00552175|144505901|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.65|||<|0.0001|TWO_SIDED|95.0|-0.85|-0.44|||Mixed Models Analysis|Covariates: Baseline value of average pain score, type of Diabetes, Duration of diabetic peripheral neuropathic pain (DPNP).|Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|||-0.44|-0.85|<0.0001
72488797|NCT00552175|144505902|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.65|||||TWO_SIDED|95.0|-0.9|-0.39|||Mixed Models Analysis|Covariates: Baseline value of average pain score, type of diabetes, and duration of diabetic peripheral neuropathic pain (DPNP).|Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|||-0.39|-0.9|
72488798|NCT00552175|144505902|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.65|||||TWO_SIDED|95.0|-0.91|-0.4|||Mixed Models Analysis|Covariates: Baseline value of average pain score, type of diabetes, and duration of diabetic peripheral neuropathic pain (DPNP).|Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|||-0.4|-0.91|
72488799|NCT00552175|144505903|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.98|||<|0.0001|TWO_SIDED|95.0|-1.34|-0.61||P-value for Worst Pain.|Mixed Models Analysis|Covariates: Baseline value of worst pain score, type of Diabetes, Duration of diabetic peripheral neuropathic pain (DPNP).|Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|||-0.61|-1.34|<0.0001
72624321|NCT00863304|144778629|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.23||0.003|TWO_SIDED|95.0|-1.16|-0.24||P-value was based on pairwise comparisons.|ANCOVA|||Week 4: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.24|-1.16|0.003
72624322|NCT00863304|144778629|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.57|STANDARD_ERROR_OF_MEAN|0.23||0.015|TWO_SIDED|95.0|-1.03|-0.11||P-value was based on pairwise comparisons.|ANCOVA|||Week 4: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.11|-1.03|0.015
72624323|NCT00863304|144778629|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.45|STANDARD_ERROR_OF_MEAN|0.23||0.053|TWO_SIDED|95.0|-0.91|0.01||P-value was based on pairwise comparisons.|ANCOVA|||Week 4: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||0.01|-0.91|0.053
72624324|NCT00863304|144778629|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.21|STANDARD_ERROR_OF_MEAN|0.23|<|0.001|TWO_SIDED|95.0|-1.66|-0.75||P-value was based on pairwise comparisons.|ANCOVA|||Week 8: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.75|-1.66|<0.001
72404095|NCT03373383|144314768|OTHER||Median Difference (Net)|7.4|||=|0.316|TWO_SIDED|95.0|-6.59|21.89||Nominal p-values were not adjusted for multiplicity.|Wilcoxon (Mann-Whitney)|||Dose group comparisons to Placebo p-value were based on the Wilcoxon-Mann-Whitney test. The Hodges-Lehmann nonparametric estimator was used to estimate the median difference between each PSL dose group versus placebo, along with the corresponding 95% CI of the estimate.||21.89|-6.59|=0.316
72488800|NCT00552175|144505903|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.85|||<|0.0001|TWO_SIDED|95.0|-1.21|-0.48||P-value for Least Pain.|Mixed Models Analysis|Covariates: Baseline value of least pain score, type of Diabetes, Duration of diabetic peripheral neuropathic pain (DPNP).|Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|||-0.48|-1.21|<0.0001
72488801|NCT00552175|144505903|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-1.0|||<|0.0001|TWO_SIDED|95.0|-1.33|-0.67||P-value for Average Pain.|Mixed Models Analysis|Covariates: Baseline value of average pain score, type of Diabetes, Duration of diabetic peripheral neuropathic pain (DPNP).|Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|||-0.67|-1.33|<0.0001
72488802|NCT00552175|144505903|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.92|||<|0.0001|TWO_SIDED|95.0|-1.29|-0.54||P-value for Pain Right Now.|Mixed Models Analysis|Covariates: Baseline value of pain right now score, type of Diabetes, Duration of diabetic peripheral neuropathic pain (DPNP).|Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|||-0.54|-1.29|<0.0001
72488803|NCT00552175|144505904|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.89|||||TWO_SIDED|95.0|-1.34|-0.44|||Mixed Models Analysis|Covariates: Baseline value of worst pain score, type of diabetes, and duration of diabetic peripheral neuropathic pain (DPNP).|Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|Worst Pain Score analysis||-0.44|-1.34|
72488804|NCT00552175|144505904|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-1.06|||||TWO_SIDED|95.0|-1.51|-0.62|||Mixed Models Analysis|Covariates: Baseline value of worst pain score, type of diabetes, and duration of diabetic peripheral neuropathic pain (DPNP).|Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|Worst Pain Score analysis||-0.62|-1.51|
72624325|NCT00863304|144778629|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.11|STANDARD_ERROR_OF_MEAN|0.23|<|0.001|TWO_SIDED|95.0|-1.56|-0.65||P-value was based on pairwise comparisons.|ANCOVA|||Week 8: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.65|-1.56|<0.001
72624326|NCT00863304|144778629|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.61|STANDARD_ERROR_OF_MEAN|0.23||0.009|TWO_SIDED|95.0|-1.07|-0.16||P-value was based on pairwise comparisons.|ANCOVA|||Week 8: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.16|-1.07|0.009
72624327|NCT00863304|144778629|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.59|STANDARD_ERROR_OF_MEAN|0.23||0.011|TWO_SIDED|95.0|-1.05|-0.14||P-value was based on pairwise comparisons.|ANCOVA|||Week 8: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.14|-1.05|0.011
72624328|NCT00863304|144778629|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.49|STANDARD_ERROR_OF_MEAN|0.23||0.035|TWO_SIDED|95.0|-0.95|-0.03||P-value was based on pairwise comparisons.|ANCOVA|||Week 8: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.03|-0.95|0.035
72488805|NCT00552175|144505904|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.78|||||TWO_SIDED|95.0|-1.23|-0.33|||Mixed Models Analysis|Covariates: Baseline value of least pain score, type of diabetes, and duration of diabetic peripheral neuropathic pain (DPNP).|Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|Least Pain Score analysis||-0.33|-1.23|
72624329|NCT00863304|144778629|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.32|STANDARD_ERROR_OF_MEAN|0.24|<|0.001|TWO_SIDED|95.0|-1.79|-0.85||P-value was based on pairwise comparisons.|ANCOVA|||Week 12: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.85|-1.79|<0.001
72488806|NCT00552175|144505904|SUPERIORITY_OR_OTHER||Least Mean Squares Difference|-0.91|||||TWO_SIDED|95.0|-1.36|-0.46|||Mixed Models Analysis|Covariates: Baseline value of least pain score, type of diabetes, and duration of diabetic peripheral neuropathic pain (DPNP).|Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|Least Pain Score analysis||-0.46|-1.36|
72488807|NCT00552175|144505904|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.98|||||TWO_SIDED|95.0|-1.39|-0.58|||Mixed Models Analysis|Covariates: Baseline value of average pain score, type of diabetes, and duration of diabetic peripheral neuropathic pain (DPNP).|Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|Average Pain Score analysis||-0.58|-1.39|
72488808|NCT00552175|144505904|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-1.01|||||TWO_SIDED|95.0|-1.41|-0.61|||Mixed Models Analysis|Covariates: Baseline value of average pain score, type of diabetes, and duration of diabetic peripheral neuropathic pain (DPNP).|Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|Average Pain Score analysis||-0.61|-1.41|
72404096|NCT03373383|144314768|OTHER||Median Difference (Net)|9.99|||=|0.133|TWO_SIDED|95.0|-3.15|23.26||Nominal p-values were not adjusted for multiplicity.|Wilcoxon (Mann-Whitney)|||Dose group comparisons to Placebo p-value were based on the Wilcoxon-Mann-Whitney test. The Hodges-Lehmann nonparametric estimator was used to estimate the median difference between each PSL dose group versus placebo, along with the corresponding 95% CI of the estimate.||23.26|-3.15|=0.133
72404097|NCT03373383|144314768|OTHER||Median Difference (Net)|8.19|||=|0.203|TWO_SIDED|95.0|-3.95|21.37||Nominal p-values were not adjusted for multiplicity.|Wilcoxon (Mann-Whitney)|||Dose group comparisons to Placebo p-value were based on the Wilcoxon-Mann-Whitney test. The Hodges-Lehmann nonparametric estimator was used to estimate the median difference between each PSL dose group versus placebo, along with the corresponding 95% CI of the estimate.||21.37|-3.95|=0.203
72404098|NCT03373383|144314768|OTHER||Median Difference (Net)|2.39|||=|0.784|TWO_SIDED|95.0|-13.65|17.79||Nominal p-values were not adjusted for multiplicity.|Wilcoxon (Mann-Whitney)|||Dose group comparisons to Placebo p-value were based on the Wilcoxon-Mann-Whitney test. The Hodges-Lehmann nonparametric estimator was used to estimate the median difference between each PSL dose group versus placebo, along with the corresponding 95% CI of the estimate.||17.79|-13.65|=0.784
72404099|NCT03317431|144314772|SUPERIORITY||||||<|0.01|||||||Regression, Linear|||Analysis the relationship between the duration of mechanical ventilation with DRD1 expression.||||<0.01
72404100|NCT03317431|144314773|SUPERIORITY||||||>|0.01|||||||Regression, Linear|||Analysis the relationship between the duration of mechanical ventilation with DRD2 expression.||||>0.01
72404101|NCT03317431|144314774|SUPERIORITY||||||>|0.01|||||||Regression, Linear|||Analysis the relationship between the duration of mechanical ventilation with TH expression.||||>0.01
72488809|NCT00552175|144505904|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.88|||||TWO_SIDED|95.0|-1.35|-0.41|||Mixed Models Analysis|Covariates: Baseline value of pain right now score, type of diabetes, and duration of diabetic peripheral neuropathic pain (DPNP).|Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|Pain Right Now Score analysis||-0.41|-1.35|
72488810|NCT00552175|144505904|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.95|||||TWO_SIDED|95.0|-1.41|-0.48|||Mixed Models Analysis|Covariates: Baseline value of pain right now score, type of diabetes, and duration of diabetic peripheral neuropathic pain (DPNP).|Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|Pain Right Now Score analysis||-0.48|-1.41|
72515961|NCT01763866|144562689|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-16.15|STANDARD_ERROR_OF_MEAN|4.61||0.005|TWO_SIDED|95.0|-25.27|-7.03||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-7.03|-25.27|0.005
72404102|NCT03317431|144314775|SUPERIORITY||||||>|0.01|||||||Regression, Linear|||Analysis the relationship between the duration of mechanical ventilation with DDC expression.||||>0.01
72404103|NCT03317431|144314776|SUPERIORITY||||||<|0.01|||||||Regression, Linear|||Analysis the relationship between the duration of mechanical ventilation with Ac-a-tubulin expression.||||<0.01
72404104|NCT04753164|144314786|OTHER|Mixed effects model for Repeated Measures: Change from baseline in the number of BE days per week = baseline number of BE days per week + sex (Male; Female) + BMI group (\< 30 ; ≥ 30 kg/m2) + treatment + visit + treatment × visit + baseline × visit.|LS Mean Difference to Placebo|0.0||||0.9992|TWO_SIDED|95.0|-0.69|0.69|||Mixed effects model f. repeated measures|||||0.69|-0.69|0.9992
72404105|NCT00694369|144314787|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||0.05 critical level was used.|ANOVA|"Step-down manner was used (p-value for 90-mg dose comparison was reported only if the p-value~for 120-mg dose comparison is significant)."||||||<0.001
72404106|NCT00694369|144314787|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||0.05 critical level was used.|ANOVA|Step-down manner was used (p-value for 90-mg dose comparison was reported only if the p-value for 120-mg dose comparison is significant)||||||<0.001
72488811|NCT00552175|144505905|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.41||||0.0676|TWO_SIDED|95.0|-0.85|0.03||P-value for General Activity.|Mixed Models Analysis|Covariates: Baseline value of general activity score, type of Diabetes, Duration of diabetic peripheral neuropathic pain (DPNP).|Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|||0.03|-0.85|0.0676
72624330|NCT00863304|144778629|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.24|STANDARD_ERROR_OF_MEAN|0.24|<|0.001|TWO_SIDED|95.0|-1.71|-0.76||P-value was based on pairwise comparisons.|ANCOVA|||Week 12: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.76|-1.71|<0.001
72404107|NCT00694369|144314787|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority bound (etoricoxib minus ibuprofen) is -4.45.|Difference in LS Means|0.06||||||95.0|-1.37|1.48|||||Difference in Least squares means (LS Means) (etoricoxib minus ibuprofen)|||1.48|-1.37|
72404108|NCT00694369|144314787|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority bound (etoricoxib minus ibuprofen) is -4.45.|Difference in LS Means|0.43||||||95.0|-0.73|1.6|||||Difference in LS Means (etoricoxib minus ibuprofen)|||1.60|-0.73|
72404109|NCT00694369|144314787|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority bound (etoricoxib minus cetaminophen/codeine) is -2.41.|Difference in LS Means|3.9||||||95.0|2.04|5.76|||||Difference in LS Means (etoricoxib minus acetaminophen/codeine)|||5.76|2.04|
72404110|NCT00694369|144314787|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority bound (etoricoxib minus acetaminophen/codeine) is -2.41.|Difference in LS Means|4.27||||||95.0|2.61|5.94|||||Difference in LS Means (etoricoxib minus acetaminophen/codeine)|||5.94|2.61|
72404111|NCT00694369|144314787|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.38||||||95.0|-1.8|1.05|||||Difference in LS Means (etoricoxib 120 mg minus etoricoxib 90 mg)|||1.05|-1.80|
72404112|NCT00694369|144314787|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|10.59||||||95.0|8.72|12.47|||||Difference in LS Means (ibuprofen 2400 mg minus placebo)|||12.47|8.72|
72404113|NCT00694369|144314787|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|6.75||||||95.0|4.53|8.97|||||Difference in LS Means (acetaminophen 2400 mg/codeine 240 mg minus placebo)|||8.97|4.53|
72404114|NCT00694369|144314788|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||0.05 critical level was used.|stratified Wilcoxon rank sum test|Step-down manner was used (p-value for 90-mg dose comparison was reported only if the p-value for 120-mg dose comparison is significant).||||||<0.001
72488812|NCT00552175|144505905|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.37||||0.0933|TWO_SIDED|95.0|-0.8|0.06||P-value for Mood.|Mixed Models Analysis|Covariates: Baseline value of mood score, type of Diabetes, Duration of diabetic peripheral neuropathic pain (DPNP).|Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|||0.06|-0.8|0.0933
72488813|NCT00552175|144505905|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.49||||0.0228|TWO_SIDED|95.0|-0.91|-0.07||P-value for Walking Ability.|Mixed Models Analysis|Covariates: Baseline value of walking ability score, type of Diabetes, Duration of diabetic peripheral neuropathic pain (DPNP).|Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|||-0.07|-0.91|0.0228
72488814|NCT00552175|144505905|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.38||||0.0783|TWO_SIDED|95.0|-0.8|0.04||P-value for Normal Work.|Mixed Models Analysis|Covariates: Baseline value of normal work score, type of Diabetes, Duration of diabetic peripheral neuropathic pain (DPNP).|Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|||0.04|-0.8|0.0783
72488815|NCT00552175|144505905|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.55||||0.0076|TWO_SIDED|95.0|-0.96|-0.15||P-value for Relation to People.|Mixed Models Analysis|Covariates: Baseline value of relation to people score, type of Diabetes, Duration of diabetic peripheral neuropathic pain (DPNP).|Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|||-0.15|-0.96|0.0076
72488816|NCT00552175|144505905|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.46||||0.0378|TWO_SIDED|95.0|-0.9|-0.03||P-value for Sleep.|Mixed Models Analysis|Covariates: Baseline value of sleep score, type of Diabetes, Duration of diabetic peripheral neuropathic pain (DPNP).|Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|||-0.03|-0.9|0.0378
72515962|NCT01763866|144562689|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-23.18|STANDARD_ERROR_OF_MEAN|4.52|<|0.001|TWO_SIDED|95.0|-32.11|-14.25||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-14.25|-32.11|<0.001
72515963|NCT01763866|144562689|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-23.21|STANDARD_ERROR_OF_MEAN|4.95|<|0.001|TWO_SIDED|95.0|-33.0|-13.43||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-13.43|-33.00|<0.001
72515964|NCT01763866|144562689|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-32.87|STANDARD_ERROR_OF_MEAN|5.43|<|0.001|TWO_SIDED|95.0|-43.6|-22.14||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit||||-22.14|-43.60|<0.001
72515965|NCT01763866|144562690|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-14.47|STANDARD_ERROR_OF_MEAN|4.92||0.088|TWO_SIDED|95.0|-24.16|-4.78||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-4.78|-24.16|0.088
72624331|NCT00863304|144778629|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.64|STANDARD_ERROR_OF_MEAN|0.24||0.008|TWO_SIDED|95.0|-1.11|-0.16||P-value was based on pairwise comparisons.|ANCOVA|||Week 12: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.16|-1.11|0.008
72515966|NCT01763866|144562690|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-26.47|STANDARD_ERROR_OF_MEAN|7.22||0.005|TWO_SIDED|95.0|-40.71|-12.24||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-12.24|-40.71|0.005
72515967|NCT01763866|144562690|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-1.54|STANDARD_ERROR_OF_MEAN|5.0||1|TWO_SIDED|95.0|-11.41|8.32||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||8.32|-11.41|1.00
72515968|NCT01763866|144562690|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-15.19|STANDARD_ERROR_OF_MEAN|7.21||0.056|TWO_SIDED|95.0|-29.4|-0.97||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-0.97|-29.40|0.056
72488817|NCT00552175|144505905|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.56||||0.0089|TWO_SIDED|95.0|-0.98|-0.14||P-value for Enjoyment of Life.|Mixed Models Analysis|Covariates: Baseline value of enjoyment of life score, type of Diabetes, Duration of diabetic peripheral neuropathic pain (DPNP).|Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|||-0.14|-0.98|0.0089
72488818|NCT00552175|144505905|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.48||||0.0095|TWO_SIDED|95.0|-0.85|-0.12||P-value for Average of Interference Scores|Mixed Models Analysis|Covariates: Baseline value of average of interference scores, type of Diabetes, Duration of diabetic peripheral neuropathic pain (DPNP).|Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|||-0.12|-0.85|0.0095
72515969|NCT01763866|144562690|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-16.42|STANDARD_ERROR_OF_MEAN|5.39||0.073|TWO_SIDED|95.0|-27.05|-5.8||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-5.80|-27.05|0.073
72515970|NCT01763866|144562690|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-9.6|STANDARD_ERROR_OF_MEAN|6.13||0.027|TWO_SIDED|95.0|-21.68|2.48||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||2.48|-21.68|0.027
72488819|NCT00552175|144505906|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.6|||||TWO_SIDED|95.0|-1.14|-0.06|||Mixed Models Analysis|Covariates: Baseline value of general activity, type of diabetes, and duration of diabetic peripheral neuropathic pain (DPNP).|Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|General Activity score analysis||-0.06|-1.14|
72488820|NCT00552175|144505906|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.23|||||TWO_SIDED|95.0|-0.77|0.32|||Mixed Models Analysis|Covariates: Baseline value of general activity, type of diabetes, and duration of diabetic peripheral neuropathic pain (DPNP).|Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|General Activity score analysis||0.32|-0.77|
72488821|NCT00552175|144505906|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.27|||||TWO_SIDED|95.0|-0.8|0.27|||Mixed Models Analysis|Covariates: Baseline value of mood score, type of diabetes, and duration of diabetic peripheral neuropathic pain (DPNP).|Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|Mood score analysis||0.27|-0.8|
72488822|NCT00552175|144505906|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.48|||||TWO_SIDED|95.0|-1.01|0.05|||Mixed Models Analysis|Covariates: Baseline value of mood score, type of diabetes, and duration of diabetic peripheral neuropathic pain (DPNP).|Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|Mood score analysis||0.05|-1.01|
72488823|NCT00552175|144505906|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.5|||||TWO_SIDED|95.0|-1.02|0.02|||Mixed Models Analysis|Covariates: Baseline value of walking ability, type of diabetes, and duration of diabetic peripheral neuropathic pain (DPNP).|Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|Walking Ability score analysis||0.02|-1.02|
72488824|NCT00552175|144505906|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.49|||||TWO_SIDED|95.0|-1.01|0.03|||Mixed Models Analysis|Covariates: Baseline value of walking ability, type of diabetes, and duration of diabetic peripheral neuropathic pain (DPNP).|Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|Walking Ability score analysis||0.03|-1.01|
72488825|NCT00552175|144505906|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.35|||||TWO_SIDED|95.0|-0.86|0.16|||Mixed Models Analysis|Covariates: Baseline value of normal work score, type of diabetes, and duration of diabetic peripheral neuropathic pain (DPNP).|Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|Normal Work score analysis||0.16|-0.86|
72488826|NCT00552175|144505906|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.41|||||TWO_SIDED|95.0|-0.92|0.11|||Mixed Models Analysis|Covariates: Baseline value of normal work score, type of diabetes, and duration of diabetic peripheral neuropathic pain (DPNP).|Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|Normal Work score analysis||0.11|-0.92|
72488827|NCT00552175|144505906|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.39|||||TWO_SIDED|95.0|-0.89|0.11|||Mixed Models Analysis|Covariates: Baseline value of relation to people, type of diabetes, and duration of diabetic peripheral neuropathic pain (DPNP).|Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|Relation to People score analysis||0.11|-0.89|
72488828|NCT00552175|144505906|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.71|||||TWO_SIDED|95.0|-1.21|-0.22|||Mixed Models Analysis|Covariates: Baseline value of relation to people, type of diabetes, and duration of diabetic peripheral neuropathic pain (DPNP).|Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|Relation to People score analysis||-0.22|-1.21|
72568554|NCT04168190|144668499|NON_INFERIORITY|Non-inferiority can be concluded if the lower bound of the 95% CI for the estimated GMT ratio (V116/PPSV23) is \>0.33 (1-sided p-value \<0.025).|GMT Ratio|1.19|||<|0.001|TWO_SIDED|95.0|0.93|1.52|||P-value is estimated from a cLDA model.||Phase 2: V116/Phase 2: Pneumovax™23|Serotype 10A. Geometric mean titer (GMT) ratio and 95% confidence interval (CI), and p-value are estimated from a constrained longitudinal data analysis (cLDA) model.||1.52|0.93|<0.001
72488829|NCT00552175|144505906|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.57|||||TWO_SIDED|95.0|-1.11|-0.03|||Mixed Models Analysis|Covariates: Baseline value of sleep score, type of diabetes, and duration of diabetic peripheral neuropathic pain (DPNP).|Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|Sleep score analysis||-0.03|-1.11|
72404115|NCT00694369|144314788|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||0.05 critical level was used.|stratified Wilcoxon rank sum test|Step-down manner was used (p-value for 90-mg dose comparison was reported only if the p-value for 120-mg dose comparison is significant)||||||<0.001
72488830|NCT00552175|144505906|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.36|||||TWO_SIDED|95.0|-0.9|0.18|||Mixed Models Analysis|Covariates: Baseline value of sleep score, type of diabetes, and duration of diabetic peripheral neuropathic pain (DPNP).|Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|Sleep score analysis||0.18|-0.9|
72488831|NCT00552175|144505906|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.37|||||TWO_SIDED|95.0|-0.88|0.15|||Mixed Models Analysis|Covariates: Baseline value of enjoyment of life, type of diabetes, and duration of diabetic peripheral neuropathic pain (DPNP).|Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|Enjoyment of Life score analysis||0.15|-0.88|
72488832|NCT00552175|144505906|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.76|||||TWO_SIDED|95.0|-1.27|-0.24|||Mixed Models Analysis|Covariates: Baseline value of enjoyment of life, type of diabetes, and duration of diabetic peripheral neuropathic pain (DPNP).|Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|Enjoyment of Life score analysis||-0.24|-1.27|
72488833|NCT00552175|144505906|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.45|||||TWO_SIDED|95.0|-0.9|0.0|||Mixed Models Analysis|Covariates: Baseline value of average of interference scores, type of diabetes, and duration of diabetic peripheral neuropathic pain (DPNP).|Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|Average of Interference scores analysis||0|-0.9|
72488834|NCT00552175|144505906|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.52|||||TWO_SIDED|95.0|-0.97|-0.07|||Mixed Models Analysis|Covariates: Baseline value of average of interference scores, type of diabetes, and duration of diabetic peripheral neuropathic pain (DPNP).|Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|Average of Interference scores analysis||-0.07|-0.97|
72488835|NCT00552175|144505907|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.11||||0.8517|TWO_SIDED|95.0|-1.22|1.01|||Mixed Models Analysis|Covariates: Baseline value of BDI-II, type of diabetes, and duration of diabetic peripheral neuropathic pain (DPNP).|Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|||1.01|-1.22|0.8517
72404116|NCT00694369|144314788|SUPERIORITY_OR_OTHER_LEGACY|||||||0.161||95.0||||0.05 critical level was used.|stratified Wilcoxon rank sum test|Nominal p-value was provided in lieu of the 95% CI. Step-down manner was used, and the nominal p-value for 90-mg dose comparison was not reported.||||||0.161
72488836|NCT00552175|144505908|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.34|||||TWO_SIDED|95.0|-1.03|1.71|||Mixed Models Analysis|Covariates: Baseline value of BDI-II, type of diabetes, and duration of diabetic peripheral neuropathic pain (DPNP).|Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|||1.71|-1.03|
72488837|NCT00552175|144505908|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.55|||||TWO_SIDED|95.0|-1.92|0.81|||Mixed Models Analysis|Covariates: Baseline value of BDI-II, type of diabetes, and duration of diabetic peripheral neuropathic pain (DPNP).|Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|||0.81|-1.92|
72488838|NCT05112536|144505909|OTHER|||||||0.101|||||||Wilcoxon signed-rank test|||||||0.101
72488839|NCT02285998|144505928|NON_INFERIORITY_OR_EQUIVALENCE|The sample size required to achieve 80% power was calculated based on a one-sided alpha level of 0.025 and an attack rate of 2% in the IIV4 and 1.53% for the Flublok groups respectively.|Relative Vaccine Efficacy (rVE)|30.0|||||TWO_SIDED|95.0|10.0|47.0||||||The primary efficacy analysis was based on the numbers of protocol-defined influenza-like illnesses with rtPCR-positive nasopharyngeal swabs detecting influenza virus of any strain. The Relative Vaccine Efficacy was 30% (10, 47). Non-inferiority would be concluded if the lower bound of the 95% CI for rVE was \> -20%. Superiority of RIV4 in a pre-specified exploratory analysis required that the lower bound of the two-sided 95% CI of rVE be \> +9%.||47|10|
72488840|NCT02662036|144505965|SUPERIORITY|||||||0.76|||||||Mann Whitney U Test|||Statistical analysis #1 is for intraoperative opioid use||||0.76
72488841|NCT02662036|144505965|SUPERIORITY|||||||0.38|||||||Mann Whitney U Test|||Statistical analysis #2 is for postoperative acute care unit opioid use||||0.38
72488842|NCT02662036|144505965|SUPERIORITY|||||||0.69|||||||Mann Whitney U Test|||Statistical analysis #3 is for postoperative floor opioid use||||0.69
72488843|NCT02662036|144505965|SUPERIORITY|||||||0.98|||||||Mann Whitney U Test|||Statistical analysis #4 is for total opioid use||||0.98
72488844|NCT02662036|144505966|SUPERIORITY|||||||0.28|||||||Mann Whitney U Test|||Statistical analysis #1 is for postoperative acute care unit antiemetic use||||0.28
72488845|NCT02662036|144505966|SUPERIORITY|||||||0.62|||||||Mann Whitney U Test|||Statistical analysis #2 is for floor antiemetic use||||0.62
72515971|NCT01763866|144562690|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-1.78|STANDARD_ERROR_OF_MEAN|5.27||1|TWO_SIDED|95.0|-12.16|8.61||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||8.61|-12.16|1.00
72488846|NCT02662036|144505966|SUPERIORITY|||||||0.5|||||||Mann Whitney U Test|||Statistical analysis #3 is for total antiemetic use||||0.50
72488847|NCT02662036|144505967|SUPERIORITY|||||||0.2|||||||Mann Whitney U Test|||||||0.20
72488848|NCT02662036|144505968|SUPERIORITY|||||||0.64|||||||Mann Whitney U Test|||||||0.64
72488849|NCT02662036|144505969|SUPERIORITY|||||||0.38|||||||Mann Whitney U Test|||||||0.38
72488850|NCT04995055|144505977|SUPERIORITY||Least-square Mean Difference|-15.4|STANDARD_ERROR_OF_MEAN|2.81|||TWO_SIDED|95.0|-21.2|-9.5|||Linear Mixed Model|Kenward and Roger method was used for denominator degrees of freedom.|Least-square Mean difference was calculated as senofilcon A (C3)- senofilcon A|||-9.5|-21.2|
72404117|NCT00694369|144314788|SUPERIORITY_OR_OTHER_LEGACY|||||||0.014||95.0||||0.05 critical level was used.|stratified Wilcoxon rank sum test|Nominal p-value was provided in lieu of the 95% CI. Step-down manner was used.||||||0.014
72404118|NCT00694369|144314788|SUPERIORITY_OR_OTHER_LEGACY|||||||0.007||95.0||||0.05 critical level was used.|stratified Wilcoxon rank sum test|Nominal p-value was provided in lieu of the 95% CI. Step-down manner was used.||||||0.007
72488851|NCT04995055|144505978|SUPERIORITY||Least-square Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|0.04|||TWO_SIDED|95.0|0.2|0.4|||Linear Mixed Model|Kenward and Roger method was used for denominator degrees of freedom.|Least-square Mean difference was calculated as senofilcon A (C3)- senofilcon A|||0.4|0.2|
72404119|NCT00314236|144314800|SUPERIORITY_OR_OTHER|||||||0.011|TWO_SIDED||||||ANCOVA|||||||0.011
72488852|NCT04995055|144505979|SUPERIORITY||Least-square Mean Difference|-3.5|STANDARD_ERROR_OF_MEAN|0.66|||TWO_SIDED|95.0|-4.9|-2.1|||Linear Mixed Model|Kenward and Roger method was used for denominator degrees of freedom.|Least-square Mean difference was calculated as senofilcon A (C3)- senofilcon A|||-2.1|-4.9|
72488853|NCT04995055|144505980|SUPERIORITY||Least-square Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|0.05|||TWO_SIDED|95.0|0.2|0.4|||Linear Mixed Model|Kenward and Roger method was used for denominator degrees of freedom.|Least-square Mean difference was calculated as senofilcon A (C3)- senofilcon A|||0.4|0.2|
72488854|NCT04995055|144505982|SUPERIORITY||Least-square Mean Difference|-3.1|STANDARD_ERROR_OF_MEAN|0.59|||TWO_SIDED|95.0|-4.4|-1.9|||Linear Mixed Model|Kenward and Roger method was used for denominator degrees of freedom.|Least-square Mean difference was calculated as senofilcon A (C3)- senofilcon A|||-1.9|-4.4|
72515972|NCT01763866|144562690|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|4.94|STANDARD_ERROR_OF_MEAN|6.18||0.62|TWO_SIDED|95.0|-7.25|17.14||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||17.14|-7.25|0.62
72515973|NCT01763866|144562690|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-21.98|STANDARD_ERROR_OF_MEAN|6.2|<|0.001|TWO_SIDED|95.0|-34.24|-9.73||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-9.73|-34.24|<0.001
72515974|NCT01763866|144562690|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-18.75|STANDARD_ERROR_OF_MEAN|6.5||0.007|TWO_SIDED|95.0|-31.6|-5.9||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-5.90|-31.60|0.007
72404120|NCT00314236|144314801|SUPERIORITY_OR_OTHER|||||||0.033|TWO_SIDED||||||ANCOVA|||||||0.033
72488855|NCT03418129|144505984|SUPERIORITY||Slope|0.2331|STANDARD_ERROR_OF_MEAN|0.2176||0.2852|TWO_SIDED||||||ANCOVA||Multilevel modeling was used to model outcome at baseline and 3-month follow-up. Resulting slopes capture change in outcome from baseline to follow-up, with relaxation set as the comparison.|||||0.2852
72488856|NCT03418129|144505984|SUPERIORITY||Slope|0.03057|STANDARD_ERROR_OF_MEAN|0.2132||0.8861|TWO_SIDED||||||ANCOVA||Multilevel modeling was used to model outcome at baseline and 3-month follow-up. Resulting slopes capture change in outcome from baseline to follow-up, with relaxation set as the comparison.|||||0.8861
72488857|NCT03418129|144505985|SUPERIORITY||Slope|-0.03844|STANDARD_ERROR_OF_MEAN|0.09424||0.6842|TWO_SIDED||||||ANOVA||Multilevel modeling was used to model outcomes at two time points (3-month follow-up and baseline) and across three treatment groups (Mindfulness, Neurofeedback, and Relaxation).|||||0.6842
72515975|NCT01763866|144562690|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-16.19|STANDARD_ERROR_OF_MEAN|5.7||0.005|TWO_SIDED|95.0|-27.46|-4.92||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-4.92|-27.46|0.005
72515976|NCT01763866|144562690|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-18.54|STANDARD_ERROR_OF_MEAN|5.31|<|0.001|TWO_SIDED|95.0|-29.04|-8.05||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-8.05|-29.04|<0.001
72515977|NCT01763866|144562690|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-22.45|STANDARD_ERROR_OF_MEAN|5.39|<|0.001|TWO_SIDED|95.0|-33.09|-11.81||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-11.81|-33.09|<0.001
72404121|NCT04654117|144314826|SUPERIORITY|Multilevel model predicting the effect of the overall consultation model on manual adherence, averaged across clinicians.|unstandardized beta|0.33|STANDARD_ERROR_OF_MEAN|3.85|<|0.05|TWO_SIDED||||||multilevel model|||||||<.05
72488858|NCT03418129|144505985|SUPERIORITY||Slope|-0.1432|STANDARD_ERROR_OF_MEAN|0.09427||0.132|TWO_SIDED||||||ANOVA||Multilevel modeling was used to model outcomes at two time points (3-month follow-up and baseline) and across three treatment groups (Mindfulness, Neurofeedback, and Relaxation).|||||0.132
72488859|NCT03418129|144505986|SUPERIORITY||Slope|0.1911|STANDARD_ERROR_OF_MEAN|0.2551||0.4542|TWO_SIDED||||||ANCOVA|||||||0.4542
72624332|NCT00863304|144778629|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.68|STANDARD_ERROR_OF_MEAN|0.24||0.005|TWO_SIDED|95.0|-1.16|-0.21||P-value was based on pairwise comparisons.|ANCOVA|||Week 12: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.21|-1.16|0.005
72404122|NCT04654117|144314827|SUPERIORITY||unstandardized beta|0.04|STANDARD_ERROR_OF_MEAN|0.08|<|0.05|TWO_SIDED||||||multilevel model|||||||<.05
72488860|NCT03418129|144505986|SUPERIORITY||Slope|-0.3761|STANDARD_ERROR_OF_MEAN|0.2454||0.1261|TWO_SIDED||||||ANCOVA|||||||0.1261
72488861|NCT00884273|144506009|NON_INFERIORITY_OR_EQUIVALENCE|"Non-inferiority was to be established if the treatment difference in adjusted (for baseline volume, and baseline total IPSS) mean percentage reduction was significantly greater (two-sided at α=0.05 level) than Δ = 10 points (non-inferiority margin) in both the FAS and PP analyses sets.~If the Week 12 treatment assessment of prostate volume was missing the LOCF approach was used, i.e., the prostate volume value closest to and before Week 12 was used."|Mean Difference (Final Values)|2.37||||0.36|TWO_SIDED|95.0|-2.78|7.52||FAS.|ANCOVA|The baseline IPSS and baseline Prostate volume were used as covariates and treatment was used as a factor in the analysis.||Estimates from analysis of variance with treatment as factors and baseline IPSS and baseline Prostate volume as covariates.||7.52|-2.78|0.36
72488862|NCT00884273|144506018|NON_INFERIORITY_OR_EQUIVALENCE|"Non-inferiority was to be established if the treatment difference in adjusted (for baseline volume, and baseline total IPSS) mean percentage reduction was significantly greater (two-sided at α=0.05 level) than Δ = 10 points (non-inferiority margin) in both the FAS and PP analyses sets.~If the Week 12 treatment assessment of prostate volume was missing the LOCF approach was used, i.e., the prostate volume value closest to and before Week 12 was used."|Mean Difference (Net)|2.24||||0.41|TWO_SIDED|95.0|-3.1|7.58||PP.|ANCOVA|The baseline IPSS and baseline Prostate volume were used as covariates and treatment was used as a factor in the analysis.||Estimates from analysis of variance with treatment as factors and baseline IPSS and baseline Prostate volume as covariates.||7.58|-3.10|0.41
72568555|NCT04168190|144668499|NON_INFERIORITY|Non-inferiority can be concluded if the lower bound of the 95% CI for the estimated GMT ratio (V116/PPSV23) is \>0.33 (1-sided p-value \<0.025).|GMT Ratio|2.27|||<|0.001|TWO_SIDED|95.0|1.78|2.9|||P-value is estimated from a cLDA model.||Phase 2: V116/Phase 2: Pneumovax™23|Serotype 11A. Geometric mean titer (GMT) ratio and 95% confidence interval (CI), and p-value are estimated from a constrained longitudinal data analysis (cLDA) model.||2.90|1.78|<0.001
72624333|NCT00863304|144778629|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.24||0.013|TWO_SIDED|95.0|-1.07|-0.12||P-value was based on pairwise comparisons.|ANCOVA|||Week 12: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.12|-1.07|0.013
72404123|NCT04654117|144314828|OTHER|multilevel modeling|multilevel modeling|2.56|STANDARD_ERROR_OF_MEAN|0.74|<|0.05|TWO_SIDED||||||multilevel modeling|||||||<.05
72404124|NCT04654117|144314829|SUPERIORITY||ANOVA|17.0|||<|0.05|TWO_SIDED||||||ANOVA|||||||<.05
72404125|NCT04654117|144314830|OTHER|multilevel model|multilevel model|0.04|STANDARD_ERROR_OF_MEAN|0.02|<|0.05|TWO_SIDED||||||multilevel model|||||||<.05
72488863|NCT03710486|144506031|SUPERIORITY||Odds Ratio (OR)|0.61|||=|0.13202|TWO_SIDED|95.0|0.32|1.16|||Regression, Logistic|p-value was estimated with a logistic regression adjusted by propensity scores inverse probability treatment weighting (PS-IPTW).|Estimated with a logistic regression adjusted by PS-IPTW.|||1.16|0.32|=0.13202
72515978|NCT01763866|144562690|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-36.83|STANDARD_ERROR_OF_MEAN|6.14|<|0.001|TWO_SIDED|95.0|-48.96|-24.7||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit||||-24.70|-48.96|<0.001
72488864|NCT03710486|144506032|SUPERIORITY||Odds Ratio (OR)|1.18|||=|0.5861|TWO_SIDED|95.0|0.65|2.13|||Regression, Logistic|p-value was estimated with a logistic regression adjusted by PS-IPTW.|Estimated with a logistic regression adjusted by PS-IPTW.|||2.13|0.65|=0.5861
72488865|NCT03710486|144506035|SUPERIORITY||Odds Ratio (OR)|0.65|||=|0.1648|TWO_SIDED|95.0|0.35|1.19|||Regression, Logistic|p-value was estimated with a logistic regression adjusted by PS-IPTW.|Estimated with a logistic regression adjusted by PS-IPTW.|||1.19|0.35|=0.1648
72488866|NCT03710486|144506036|SUPERIORITY||Odds Ratio (OR)|0.66|||=|0.1732|TWO_SIDED|95.0|0.36|1.2|||Regression, Logistic|p-value was estimated with a logistic regression adjusted by PS-IPTW.|Estimated with a logistic regression adjusted by PS-IPTW.|||1.20|0.36|=0.1732
72488867|NCT03710486|144506039|SUPERIORITY||||||=|0.2011|||||||Log Rank Test Adjusted by PS-IPTW|p-value was estimated with Log Rank test adjusted by PS-IPTW. Multiple Imputation has been performed to estimate PS-IPTW.||CD: Vedolizumab Versus Other Biological||||=0.2011
72488868|NCT03710486|144506040|SUPERIORITY||||||=|0.6939|||||||Log Rank Test Adjusted by PS-IPTW|p-value was estimated with Log Rank test adjusted by PS-IPTW. Multiple Imputation has been performed to estimate PS-IPTW.||||||=0.6939
72488869|NCT03710486|144506041|SUPERIORITY||Odds Ratio (OR)|0.29|||=|0.0071|TWO_SIDED|95.0|0.12|0.71|||Regression, Logistic|p-value was estimated with a logistic regression adjusted by PS-IPTW.|Estimated with a logistic regression adjusted by PS-IPTW.|||0.71|0.12|=0.0071
72488870|NCT03710486|144506042|SUPERIORITY||Odds Ratio (OR)|1.28|||=|0.4809|TWO_SIDED|95.0|0.64|2.55|||Regression, Logistic|p-value was estimated with a logistic regression adjusted by PS-IPTW.|Estimated with a logistic regression adjusted by PS-IPTW.|||2.55|0.64|=0.4809
72488871|NCT03710486|144506043|SUPERIORITY||Odds Ratio (OR)|1.05|||=|0.915|TWO_SIDED|95.0|0.46|2.36|||Regression, Logistic|p-value was estimated with a logistic regression adjusted by PS-IPTW.|Estimated with a logistic regression adjusted by PS-IPTW.|||2.36|0.46|=0.9150
72488872|NCT03710486|144506044|SUPERIORITY||Odds Ratio (OR)|1.13|||=|0.7254|TWO_SIDED|95.0|0.56|2.28|||Regression, Logistic|p-value was estimated with a logistic regression adjusted by PS-IPTW.|Estimated with a logistic regression adjusted by PS-IPTW.|||2.28|0.56|=0.7254
72488873|NCT03710486|144506045|SUPERIORITY||Odds Ratio (OR)|0.34|||=|0.0051|TWO_SIDED|95.0|0.16|0.72|||Regression, Logistic|p-value was estimated with a logistic regression adjusted by PS-IPTW.|Estimated with a logistic regression adjusted by PS-IPTW.|||0.72|0.16|=0.0051
72488874|NCT03710486|144506046|SUPERIORITY||Odds Ratio (OR)|0.53|||=|0.0653|TWO_SIDED|95.0|0.27|1.04|||Regression, Logistic|p-value was estimated with a logistic regression adjusted by PS-IPTW.|Estimated with a logistic regression adjusted by PS-IPTW.|||1.04|0.27|=0.0653
72488875|NCT03710486|144506047|SUPERIORITY||Odds Ratio (OR)|0.9|||=|0.7629|TWO_SIDED|95.0|0.47|1.74|||Regression, Logistic|p-value was estimated with a logistic regression adjusted by PS-IPTW.|Estimated with a logistic regression adjusted by PS-IPTW.|||1.74|0.47|=0.7629
72488876|NCT03710486|144506048|SUPERIORITY||Odds Ratio (OR)|0.8|||=|0.4895|TWO_SIDED|95.0|0.43|1.5|||Regression, Logistic|p-value was estimated with a logistic regression adjusted by PS-IPTW.|Estimated with a logistic regression adjusted by PS-IPTW.|||1.50|0.43|=0.4895
72488877|NCT03710486|144506049|SUPERIORITY||Odds Ratio (OR)|0.76|||=|0.4458|TWO_SIDED|95.0|0.38|1.54|||Regression, Logistic|p-value was estimated with a logistic regression adjusted by PS-IPTW.|Estimated with a logistic regression adjusted by PS-IPTW.|||1.54|0.38|=0.4458
72488878|NCT03710486|144506050|SUPERIORITY||Odds Ratio (OR)|0.98|||=|0.9471|TWO_SIDED|95.0|0.47|2.04|||Regression, Logistic|p-value was estimated with a logistic regression adjusted by PS-IPTW.|Estimated with a logistic regression adjusted by PS-IPTW.|||2.04|0.47|=0.9471
72488879|NCT03710486|144506051|SUPERIORITY||Odds Ratio (OR)|0.42|||=|0.0104|TWO_SIDED|95.0|0.21|0.81|||Regression, Logistic|p-value was estimated with a logistic regression adjusted by PS-IPTW.|Estimated with a logistic regression adjusted by PS-IPTW.|||0.81|0.21|=0.0104
72488880|NCT03710486|144506052|SUPERIORITY||Odds Ratio (OR)|0.26|||=|0.0011|TWO_SIDED|95.0|0.12|0.59|||Regression, Logistic|p-value was estimated with a logistic regression adjusted by PS-IPTW.|Estimated with a logistic regression adjusted by PS-IPTW.|||0.59|0.12|=0.0011
72488881|NCT03710486|144506053|SUPERIORITY||Odds Ratio (OR)|0.98|||=|0.9471|TWO_SIDED|95.0|0.47|2.04|||Regression, Logistic|p-value was estimated with a logistic regression adjusted by PS-IPTW.|Estimated with a logistic regression adjusted by PS-IPTW.|CD Participants||2.04|0.47|=0.9471
72568556|NCT04168190|144668499|NON_INFERIORITY|Non-inferiority can be concluded if the lower bound of the 95% CI for the estimated GMT ratio (V116/PPSV23) is \>0.33 (1-sided p-value \<0.025).|GMT Ratio|2.57|||<|0.001|TWO_SIDED|95.0|1.86|3.55|||P-value is estimated from a cLDA model.||Phase 2: V116/Phase 2: Pneumovax™23|Serotype 12F. Geometric mean titer (GMT) ratio and 95% confidence interval (CI), and p-value are estimated from a constrained longitudinal data analysis (cLDA) model.||3.55|1.86|<0.001
72515979|NCT01763866|144562691|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|6.53|STANDARD_ERROR_OF_MEAN|1.84||0.034|TWO_SIDED|95.0|2.91|10.15||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||10.15|2.91|0.034
72488882|NCT03710486|144506054|SUPERIORITY||Odds Ratio (OR)|0.3|||=|0.0104|TWO_SIDED|95.0|0.12|0.75|||Regression, Logistic|p-value was estimated with a logistic regression adjusted by PS-IPTW.|Estimated with a logistic regression adjusted by PS-IPTW.|||0.75|0.12|=0.0104
72488883|NCT03710486|144506055|SUPERIORITY||Odds Ratio (OR)|0.26|||=|0.0011|TWO_SIDED|95.0|0.12|0.59|||Regression, Logistic|p-value was estimated with a logistic regression adjusted by PS-IPTW.|Estimated with a logistic regression adjusted by PS-IPTW.|||0.59|0.12|=0.0011
72488884|NCT03710486|144506056|SUPERIORITY||Odds Ratio (OR)|1.28|||=|0.54|TWO_SIDED|95.0|0.59|2.78|||Regression, Logistic|p-value was estimated with a logistic regression adjusted by PS-IPTW.|Estimated with a logistic regression adjusted by PS-IPTW.|||2.78|0.59|=0.5400
72568557|NCT04168190|144668499|NON_INFERIORITY|Non-inferiority can be concluded if the lower bound of the 95% CI for the estimated GMT ratio (V116/PPSV23) is \>0.33 (1-sided p-value \<0.025).|GMT Ratio|1.64|||<|0.001|TWO_SIDED|95.0|1.24|2.16|||P-value is estimated from a cLDA model.||Phase 2: V116/Phase 2: Pneumovax™23|Serotype 17F. Geometric mean titer (GMT) ratio and 95% confidence interval (CI), and p-value are estimated from a constrained longitudinal data analysis (cLDA) model.||2.16|1.24|<0.001
72488885|NCT03710486|144506057|SUPERIORITY||Odds Ratio (OR)|1.21|||=|0.8123|TWO_SIDED|95.0|0.26|5.66|||Regression, Logistic|p-value was estimated with a logistic regression adjusted by PS-IPTW.|Estimated with a logistic regression adjusted by PS-IPTW.|||5.66|0.26|=0.8123
72488886|NCT03710486|144506058|SUPERIORITY||Odds Ratio (OR)|0.22|||=|0.0282|TWO_SIDED|95.0|0.06|0.85|||Regression, Logistic|p-value was estimated with a logistic regression adjusted by PS-IPTW.|Estimated with a logistic regression adjusted by PS-IPTW.|||0.85|0.06|=0.0282
72488887|NCT03710486|144506059|SUPERIORITY||Odds Ratio (OR)|1.13|||=|0.8584|TWO_SIDED|95.0|0.29|4.36|||Regression, Logistic|p-value was estimated with a logistic regression adjusted by PS-IPTW.|Estimated with a logistic regression adjusted by PS-IPTW.|||4.36|0.29|=0.8584
72488888|NCT03710486|144506060|SUPERIORITY||Odds Ratio (OR)|0.95|||=|0.9474|TWO_SIDED|95.0|0.24|3.78|||Regression, Logistic|p-value was estimated with a logistic regression adjusted by PS-IPTW.|Estimated with a logistic regression adjusted by PS-IPTW.|||3.78|0.24|=0.9474
72488889|NCT03710486|144506061|SUPERIORITY||Odds Ratio (OR)|0.73|||=|0.3103|TWO_SIDED|95.0|0.4|1.34|||Regression, Logistic|p-value was estimated with a logistic regression adjusted by PS-IPTW.|The incidence comparison was estimated by using a logistic regression adjusted by PS-IPTW. Multiple Imputation has been performed to estimate PS-IPTW.|Adverse event||1.34|0.40|=0.3103
72404126|NCT04654117|144314831|OTHER|multilevel model|multilevel model (beta)|-0.27|STANDARD_ERROR_OF_MEAN|0.15|<|0.05|TWO_SIDED||||||multilevel model|||||||<.05
72404127|NCT01951157|144314833|SUPERIORITY||The exact binomial estimator|29.2|||||TWO_SIDED|95.0|13.2|48.4||||||The exact binomial estimator and its 95%CI was used. A pre-planned Bayesian supportive analysis test comparing PFS4 was performed.||48.4|13.2|
72404128|NCT01951157|144314833|SUPERIORITY||The exact binomial estimator|19.0|||||TWO_SIDED|95.0|5.7|37.9||||||The exact binomial estimator and its 95%CI was used. A pre-planned Bayesian supportive analysis test comparing PFS4 was performed||37.9|5.7|
72404129|NCT01951157|144314833|SUPERIORITY||The exact binomial estimator|28.0|||||TWO_SIDED|95.0|12.6|46.7||||||The exact binomial estimator and its 95%CI was used. A pre-planned Bayesian supportive analysis test comparing PFS4 was performed||46.7|12.6|
72624334|NCT00863304|144778629|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.29|STANDARD_ERROR_OF_MEAN|0.24|<|0.001|TWO_SIDED|95.0|-1.76|-0.81||P-value was based on pairwise comparisons.|ANCOVA|||Week 16: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.81|-1.76|<0.001
72404130|NCT01951157|144314834|SUPERIORITY|Pre-specified|||||=|0.3873|||||||Log Rank|||||||= 0.3873
72404131|NCT01951157|144314838|SUPERIORITY|Pre-specified|||||=|0.0177|||||||Log Rank|||||||= 0.0177
72404132|NCT01951157|144314839|SUPERIORITY_OR_OTHER_LEGACY|Pre-specified||||||0.3526|||||||Log Rank|||||||0.3526
72404133|NCT01951157|144314840|SUPERIORITY|Pre-specified||||||0.9026|||||||Wilcoxon signed ranks test repeat analys|||Changes in QoL scores over time were calculated and tested for statistical significance by means of wilcoxon signed ranks test repeat-measure analyses of variance.||||0.9026
72404134|NCT01951157|144314840|SUPERIORITY|||||||0.9862|||||||Wilcoxon signed ranks test repeat analys|||Changes in QoL scores over time were calculated and tested for statistical significance by means of wilcoxon signed ranks test repeat-measure analyses of variance.||||0.9862
72404135|NCT01951157|144314840|SUPERIORITY|||||||0.8057|||||||Wilcoxon signed ranks test repeat analys|||Changes in QoL scores over time were calculated and tested for statistical significance by means of ilcoxon signed ranks test repeat-measure analyses of variance.||||0.8057
72488890|NCT03710486|144506061|SUPERIORITY||Odds Ratio (OR)|0.41|||=|0.0045|TWO_SIDED|95.0|0.22|0.76|||Regression, Logistic|p-value was estimated with a logistic regression adjusted by PS-IPTW.|The incidence comparison was estimated by using a logistic regression adjusted by PS-IPTW. Multiple Imputation has been performed to estimate PS-IPTW.|Adverse event||0.76|0.22|=0.0045
72488891|NCT03710486|144506061|SUPERIORITY||Odds Ratio (OR)|1.19|||=|0.6287|TWO_SIDED|95.0|0.59|2.42|||Regression, Logistic|p-value was estimated with a logistic regression adjusted by PS-IPTW.|The incidence comparison was estimated by using a logistic regression adjusted by PS-IPTW. Multiple Imputation has been performed to estimate PS-IPTW.|Serious adverse event||2.42|0.59|=0.6287
72488892|NCT03710486|144506061|SUPERIORITY||Odds Ratio (OR)|0.65|||=|0.2495|TWO_SIDED|95.0|0.31|1.36|||Regression, Logistic|p-value was estimated with a logistic regression adjusted by PS-IPTW.|The incidence comparison was estimated by using a logistic regression adjusted by PS-IPTW. Multiple Imputation has been performed to estimate PS-IPTW.|Serious adverse event||1.36|0.31|=0.2495
72488893|NCT03710486|144506062|SUPERIORITY||Risk Ratio (RR)|0.89|||=|0.4784|TWO_SIDED|95.0|0.66|1.22|||Poisson Regression|p-value was estimated with a Poisson regression including the following time adjusted by PS-IPTW.|The incidence rate comparison was estimated by using a Poisson regression adjusted by PS-IPTW. Multiple Imputation has been performed to estimate PS-IPTW.|Adverse event||1.22|0.66|=0.4784
72624335|NCT00863304|144778629|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.11|STANDARD_ERROR_OF_MEAN|0.24|<|0.001|TWO_SIDED|95.0|-1.58|-0.63||P-value was based on pairwise comparisons.|ANCOVA|||Week 16: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.63|-1.58|<0.001
72404136|NCT04809220|144314841|SUPERIORITY||LS Mean Difference|-0.29|||<|0.001|TWO_SIDED|95.0|-0.43|-0.14|||Mixed Models Analysis|||||-0.14|-0.43|<.001
72404137|NCT04809220|144314842|SUPERIORITY||LS Mean Difference|-0.31|||<|0.001|TWO_SIDED|95.0|-0.47|-0.15|||Mixed Models Analysis|||||-0.15|-0.47|<.001
72404138|NCT04809220|144314843|SUPERIORITY||Odds Ratio (OR)|1.15||||0.56|TWO_SIDED|95.0|0.71|1.87|||Generalized Linear Mixed Model (GLM)|||For HbA1c ≤6.5%||1.87|0.71|0.560
72404139|NCT04809220|144314843|SUPERIORITY||Odds Ratio (OR)|1.61||||0.028|TWO_SIDED|95.0|1.05|2.45|||Generalized Linear Mixed Model (GLM)|||For HbA1c \< 7%||2.45|1.05|0.028
72404140|NCT04809220|144314844|SUPERIORITY||LS Mean Difference|-9.4|||<|0.001|TWO_SIDED|95.0|-14.4|-4.3|||Mixed Models Analysis|||||-4.3|-14.4|<.001
72404141|NCT04809220|144314845|SUPERIORITY||LS Mean Difference|-7.2||||0.002|TWO_SIDED|95.0|-11.7|-2.7|||ANCOVA|||Morning premeal-fasting||-2.7|-11.7|0.002
72404142|NCT04809220|144314845|SUPERIORITY||LS Mean Difference|-10.1||||0.016|TWO_SIDED|95.0|-18.3|-1.9|||ANCOVA|||Morning 2-hour post meal||-1.9|-18.3|0.016
72404143|NCT04809220|144314845|SUPERIORITY||LS Mean Difference|-8.3||||0.007|TWO_SIDED|95.0|-14.2|-2.3|||ANCOVA|||Midday premeal||-2.3|-14.2|0.007
72404144|NCT04809220|144314845|SUPERIORITY||LS Mean Difference|-12.5||||0.002|TWO_SIDED|95.0|-20.5|-4.5|||ANCOVA|||Midday 2-hour post meal||-4.5|-20.5|0.002
72404145|NCT04809220|144314845|SUPERIORITY||LS Mean Difference|-3.9||||0.158|TWO_SIDED|95.0|-9.3|1.5|||ANCOVA|||Evening premeal||1.5|-9.3|0.158
72404146|NCT04809220|144314845|SUPERIORITY||LS Mean Difference|-11.3||||0.004|TWO_SIDED|95.0|-19.0|-3.7|||ANCOVA|||Evening 2-hour post meal||-3.7|-19.0|0.004
72404147|NCT04809220|144314846|SUPERIORITY||LS Mean Difference|-0.3||||0.213|TWO_SIDED|95.0|-0.8|0.2|||Mixed Models Analysis|||||0.2|-0.8|0.213
72404148|NCT05218018|144314847|OTHER|||||||0.002|||||||t-test, 2 sided|||||||.002
72404149|NCT00978068|144314858|SUPERIORITY_OR_OTHER||Incidence Rate Ratio|0.59||||0.04|TWO_SIDED|95.0|0.36|0.97|||Negative Binomial Regression||Group 1 represents the numerator for the rate ratio. Group 2 represents the denominator for the rate ratio.|We assumed that the incidence of malaria in Group 2 would be 0.70 episodes per person-year and estimated that we would need a sample of 300 participants for the study to have 80% power to show a 35% reduction in the incidence of malaria in Group 1, at a 2-sided significance level of 0.05. We then observed an incidence of malaria in Group 2 that was higher than anticipated (2.19 episodes/person-yr) and revised the sample size to 150 participants, who would be followed for at least 6 months.||0.97|0.36|0.04
72404150|NCT00978068|144314859|SUPERIORITY_OR_OTHER|||||||0.13|TWO_SIDED||||||Cox Proportional-Hazards|||||||0.13
72404151|NCT00978068|144314860|SUPERIORITY_OR_OTHER||Incidence Rate Ratio|0.8||||0.87|TWO_SIDED|95.0|0.06|11.16|||Negative Binomial Regression||Group 1 represents the numerator for the rate ratio. Group 2 represents the denominator for the rate ratio.|We assumed that the incidence of malaria in Group 2 would be 0.70 episodes per person-year and estimated that we would need a sample of 300 participants for the study to have 80% power to show a 35% reduction in the incidence of malaria in Group 1, at a 2-sided significance level of 0.05. We then observed an incidence of malaria in Group 2 that was higher than anticipated (2.19 episodes/person-yr) and revised the sample size to 150 participants, who would be followed for at least 6 months.||11.16|0.06|0.87
72404152|NCT00978068|144314861|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.71||||0.14|TWO_SIDED|95.0|0.45|1.12|||Cox Proportional-Hazards|Adjustment for repeated measures in the same patient|Group 1 represents the numerator for the hazard ratio. Group 2 represents the denominator for the hazard ratio.|||1.12|0.45|0.14
72404153|NCT00978068|144314862|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.31||||0.004|TWO_SIDED|95.0|0.14|0.68|||Cox Proportional-Hazards|Adjustment for repeated measures in same participant.|Group 1 represents the numerator for the hazard ratio. Group 2 represents the denominator for the hazard ratio.|||0.68|0.14|0.004
72404154|NCT00978068|144314863|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.41||||0.004|TWO_SIDED|95.0|0.22|0.76|||Cox Proportional-Hazards|Adjustment for repeated measures in the same patient.|Group 1 represents the numerator in the hazard ratio. Group 2 represents the denominator in the hazard ratio.|||0.76|0.22|0.004
72404155|NCT02120794|144314871|NON_INFERIORITY|non-inferiority test with an A1C margin of 0.4% and a significance level of 0.025 (one-sided).|Mean Difference (Net)|0.26|||||TWO_SIDED|95.0|0.125|0.395||||||||0.395|0.125|
72624336|NCT00863304|144778629|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.47|STANDARD_ERROR_OF_MEAN|0.24||0.05|TWO_SIDED|95.0|-0.95|0.0||P-value was based on pairwise comparisons.|ANCOVA|||Week 16: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.00|-0.95|0.050
72404156|NCT00181961|144314912|SUPERIORITY|||||||0.016|||||||Wilcoxon (Mann-Whitney)|||||||.016
72404157|NCT01667978|144314914|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||t-test, 2 sided|||||||<0.05
72404158|NCT01324349|144314948|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|2.0|||<|0.0001|||||||Log Rank||Median difference equals control median minus Hemostatic Patch median in minutes.|The primary effectiveness endpoint was time to hemostasis. The Kaplan-Meier method was used to estimate the survival distribution and to obtain the estimated median time to hemostasis for each treatment. Subjects who did not achieve hemostasis by 10 minutes were to be censored as of that time point. For each treatment, 95% Brookmeyer-Crowley confidence intervals for the median were computed based upon the sign test.||||<0.0001
72404159|NCT01324349|144314949|SUPERIORITY_OR_OTHER||Risk Difference (RD)|23.2||||0.0339|TWO_SIDED|95.0|1.9|47.3|||Suissa and Shuster test||Risk difference equals percentage hemostasis for Hemostatic Patch minus percentage hemostasis for control.|The secondary effectiveness endpoint was hemostasis within 3 minutes. The number and percentage of subjects who achieved hemostasis within 3 minutes are presented for each treatment group. The proportions of subjects who achieved hemostasis within 3 minutes were compared between treatments using the Suissa and Shuster test. Additionally, a 95% Blyth-Still-Casella confidence interval for the true proportion was computed for each treatment.||47.3|1.9|0.0339
72404160|NCT01324349|144314950|SUPERIORITY_OR_OTHER||Risk Difference (RD)|10.5||||0.5029|||||||Fisher Exact||Risk difference equals percent of subjects with any treatment emergent adverse events in control group minus percent of subjects with any treatment emergent adverse events in Hemostatic Patch group.|The incidence of subjects experiencing treatment-emergent adverse events (TEAEs) (defined under this protocol as Adverse Events) was summarized by MedDRA system organ class (SOC) and preferred term (PT) for each treatment group for the safety population. Tests for differences between the two treatments in the proportion of subjects experiencing any adverse event were made using Fisher's Exact Test.||||0.5029
72404161|NCT02196324|144314963|SUPERIORITY||Mean Difference (Final Values)|-0.9|STANDARD_ERROR_OF_MEAN|0.34|=|0.0111|TWO_SIDED|95.0|-1.5|-0.2|||Mixed Models Analysis|||||-0.2|-1.5|= 0.0111
72404162|NCT02196324|144314964|SUPERIORITY||Mean Difference (Final Values)|-1.0|STANDARD_ERROR_OF_MEAN|0.43|=|0.0248|TWO_SIDED|95.0|-1.8|-0.1|||Mixed Models Analysis|||||-0.1|-1.8|= 0.0248
72404163|NCT02196324|144314965|SUPERIORITY||Mean Difference (Final Values)|-1.7|STANDARD_ERROR_OF_MEAN|0.47||0.0005|TWO_SIDED|95.0|-2.6|-0.7|||Mixed Models Analysis|||||-0.7|-2.6|0.0005
72404164|NCT02196324|144314971|SUPERIORITY||Mean Difference (Final Values)|-0.7|||||TWO_SIDED|95.0|-1.4|0.0||||||Week 2||-0.0|-1.4|
72404165|NCT02196324|144314971|SUPERIORITY||Mean Difference (Final Values)|-0.9|||||TWO_SIDED|95.0|-1.7|-0.1||||||Week 4||-0.1|-1.7|
72404166|NCT02196324|144314971|SUPERIORITY||Mean Difference (Final Values)|-1.1||||0.0175|TWO_SIDED|95.0|-2.0|-0.2||p-value assume equal variance|t-test, 2 sided|||Week 8||-0.2|-2.0|0.0175
72404167|NCT02196324|144314972|SUPERIORITY||Mean Difference (Final Values)|-0.7|||||TWO_SIDED|95.0|-3.1|1.6||||||Week 2||1.6|-3.1|
72404168|NCT02196324|144314972|SUPERIORITY||Mean Difference (Final Values)|-0.2|||||TWO_SIDED|95.0|-2.7|2.3||||||Week 4||2.3|-2.7|
72488894|NCT03710486|144506062|SUPERIORITY||Risk Ratio (RR)|0.83|||=|0.2616|TWO_SIDED|95.0|0.6|1.15|||Poisson Regression|p-value was estimated with a Poisson regression including the following time adjusted by PS-IPTW.|The incidence rate comparison was estimated by using a Poisson regression adjusted by PS-IPTW. Multiple Imputation has been performed to estimate PS-IPTW.|Adverse event||1.15|0.60|=0.2616
72488895|NCT03710486|144506062|SUPERIORITY||Risk Ratio (RR)|2.01|||=|0.0077|TWO_SIDED|95.0|1.2|3.34|||Poisson Regression|p-value was estimated with a Poisson regression including the following time adjusted by PS-IPTW.|The incidence rate comparison was estimated by using a Poisson regression adjusted by PS-IPTW. Multiple Imputation has been performed to estimate PS-IPTW.|Serious adverse event||3.34|1.20|=0.0077
72488896|NCT03710486|144506062|SUPERIORITY||Risk Ratio (RR)|1.3|||=|0.3046|TWO_SIDED|95.0|0.79|2.14|||Poisson Regression|p-value was estimated with a Poisson regression including the following time adjusted by PS-IPTW.|The incidence rate comparison was estimated by using a Poisson regression adjusted by PS-IPTW. Multiple Imputation has been performed to estimate PS-IPTW.|Serious adverse event||2.14|0.79|=0.3046
72488897|NCT03710486|144506063|SUPERIORITY||Odds Ratio (OR)|0.54|||=|0.1681|TWO_SIDED|95.0|0.22|1.3|||Regression, Logistic|p-value was estimated with a logistic regression adjusted by PS-IPTW.|The incidence comparison was estimated by using a logistic regression adjusted by PS-IPTW. Multiple Imputation has been performed to estimate PS-IPTW.|Adverse events related to treatment||1.30|0.22|=0.1681
72488898|NCT03710486|144506063|SUPERIORITY||Odds Ratio (OR)|0.23|||=|0.0645|TWO_SIDED|95.0|0.05|1.09|||Regression, Logistic|p-value was estimated with a logistic regression adjusted by PS-IPTW.|The incidence comparison was estimated by using a logistic regression adjusted by PS-IPTW. Multiple Imputation has been performed to estimate PS-IPTW.|Adverse events related to treatment||1.09|0.05|=0.0645
72488899|NCT03710486|144506063|SUPERIORITY||Odds Ratio (OR)|0.38|||=|0.3145|TWO_SIDED|95.0|0.06|2.51|||Regression, Logistic|p-value was estimated with a logistic regression adjusted by PS-IPTW.|The incidence comparison was estimated by using a logistic regression adjusted by PS-IPTW. Multiple Imputation has been performed to estimate PS-IPTW.|Serious adverse events related to treatment||2.51|0.06|=0.3145
72488900|NCT03710486|144506063|SUPERIORITY||Odds Ratio (OR)|1.49|||=|0.8197|TWO_SIDED|95.0|0.05|47.11|||Regression, Logistic|p-value was estimated with a logistic regression adjusted by PS-IPTW.|The incidence comparison was estimated by using a logistic regression adjusted by PS-IPTW. Multiple Imputation has been performed to estimate PS-IPTW.|Serious adverse events related to treatment||47.11|0.05|=0.8197
72488901|NCT03710486|144506064|SUPERIORITY||Risk Ratio (RR)|0.43|||=|0.0239|TWO_SIDED|95.0|0.2|0.89|||Poisson Regression|p-value was estimated with a Poisson regression including the following time adjusted by PS-IPTW.|The incidence rate comparison was estimated by using a Poisson regression adjusted by PS-IPTW. Multiple Imputation has been performed to estimate PS-IPTW.|Adverse events related to treatment||0.89|0.20|=0.0239
72488902|NCT03710486|144506064|SUPERIORITY||Risk Ratio (RR)|0.21|||=|0.0373|TWO_SIDED|95.0|0.05|0.91|||Poisson Regression|p-value was estimated with a Poisson regression including the following time adjusted by PS-IPTW.|The incidence rate comparison was estimated by using a Poisson regression adjusted by PS-IPTW. Multiple Imputation has been performed to estimate PS-IPTW.|Adverse events related to treatment||0.91|0.05|=0.0373
72404169|NCT02196324|144314972|SUPERIORITY||Mean Difference (Final Values)|-0.8|||||TWO_SIDED|95.0|-3.6|2.1||||||Week 8||2.1|-3.6|
72404170|NCT02196324|144314973|SUPERIORITY||Mean Difference (Final Values)|-0.1|||||TWO_SIDED|95.0|-0.4|0.1||||||Week 2||0.1|-0.4|
72404171|NCT02196324|144314973|SUPERIORITY||Mean Difference (Final Values)|-0.1|||||TWO_SIDED|95.0|-0.4|0.2||||||Week 4||0.2|-0.4|
72488903|NCT03710486|144506064|SUPERIORITY||Risk Ratio (RR)|0.54|||=|0.426|TWO_SIDED|95.0|0.12|2.49|||Poisson Regression|p-value was estimated with a Poisson regression including the following time adjusted by PS-IPTW.|The incidence rate comparison was estimated by using a Poisson regression adjusted by PS-IPTW. Multiple Imputation has been performed to estimate PS-IPTW.|Serious adverse events related to treatment||2.49|0.12|=0.4260
72488904|NCT03710486|144506064|SUPERIORITY||Risk Ratio (RR)|1.56|||=|0.8012|TWO_SIDED|95.0|0.05|48.44|||Poisson Regression||The incidence rate comparison was estimated by using a Poisson regression adjusted by PS-IPTW. Multiple Imputation has been performed to estimate PS-IPTW.|Serious adverse events related to treatment||48.44|0.05|=0.8012
72488905|NCT03710486|144506065|SUPERIORITY||Odds Ratio (OR)|0.17|||=|0.0044|TWO_SIDED|95.0|0.05|0.58|||Regression, Logistic|p-value was estimated with a logistic regression adjusted by PS-IPTW.|The incidence comparison was estimated by using a logistic regression adjusted by PS-IPTW. Multiple Imputation has been performed to estimate PS-IPTW.|||0.58|0.05|=0.0044
72404172|NCT02196324|144314973|SUPERIORITY||Mean Difference (Final Values)|-0.2|||||TWO_SIDED|95.0|-0.6|0.1||||||Week 8||0.1|-0.6|
72404173|NCT02196324|144314974|SUPERIORITY||Mean Difference (Final Values)|0.35||||0.0625|TWO_SIDED|95.0|-0.02|0.72||p-value assume equal variance.|t-test, 2 sided|||||0.72|-0.02|0.0625
72404174|NCT00692770|144314979|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.94|||=|0.258329|TWO_SIDED|95.0|0.78|1.134||One sided P-value was stratified by region, risk of recurrence and previous curative treatment.|Log Rank|||||1.134|0.78|=0.258329
72404175|NCT00692770|144314980|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.891|||=|0.121383|TWO_SIDED|95.0|0.735|1.081||One sided P-value was stratified by region, risk of recurrence and previous curative treatment.|Log Rank|||||1.081|0.735|=0.121383
72488906|NCT03710486|144506065|SUPERIORITY||Odds Ratio (OR)|0.32|||=|0.0215|TWO_SIDED|95.0|0.12|0.84|||Regression, Logistic|p-value was estimated with a logistic regression adjusted by PS-IPTW.|The incidence comparison was estimated by using a logistic regression adjusted by PS-IPTW. Multiple Imputation has been performed to estimate PS-IPTW.|||0.84|0.12|=0.0215
72488907|NCT03710486|144506066|SUPERIORITY||Risk Ratio (RR)|0.27|||=|0.0152|TWO_SIDED|95.0|0.1|0.78|||Poisson Regression|p-value was estimated with a Poisson regression including the following time adjusted by PS-IPTW.|The incidence rate comparison was estimated by using a Poisson regression adjusted by PS-IPTW. Multiple Imputation has been performed to estimate PS-IPTW.|||0.78|0.10|=0.0152
72488908|NCT03710486|144506066|SUPERIORITY||Risk Ratio (RR)|1.56|||=|0.8012|TWO_SIDED|95.0|0.05|48.44|||Poisson Regression|p-value was estimated with a Poisson regression including the following time adjusted by PS-IPTW.|The incidence rate comparison was estimated by using a Poisson regression adjusted by PS-IPTW. Multiple Imputation has been performed to estimate PS-IPTW.|||48.44|0.05|=0.8012
72488909|NCT01147744|144506091|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.056||||0.326|TWO_SIDED|95.0|-0.06|0.17||The study type I error rate was controlled at 5% level for primary efficacy analyses using the Week 8 trough FEV1 endpoint, by performing statistical tests of GSK2190915 versus placebo, sequentially from highest dose (300 mg) to lowest dose (10 mg).|ANCOVA|ANCOVA model used with covariates of Baseline trough FEV1, age, gender, country and smoking status. The LOCF method used to impute missing data.||||0.17|-0.06|0.326
72404176|NCT00692770|144314981|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.995|||=|0.484742|TWO_SIDED|95.0|0.761|1.3||One-sided P-value was stratified by region, risk of recurrence and previous curative treatment.|Log Rank|||||1.3|0.761|=0.484742
72404177|NCT00692770|144314982|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.039|||<|0.0001|TWO_SIDED|95.0|0.025|0.052|||ANCOVA|||An analysis of covariance (ANCOVA) model was used to estimate the mean difference in the timeadjusted Area Under Curve (AUC) between the two treatment groups, with covariates for baseline scores and stratification factors. To test the treatment effect, a mixed linear model (random coefficient model) was used for the EQ-5D index score. Statistical tests were performed with a 2 sided type I error of 5%.||0.052|0.025|<0.0001
72404178|NCT00692770|144314983|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.978|||<|0.0001|TWO_SIDED|95.0|1.797|4.159|||ANCOVA|||An analysis of covariance (ANCOVA) model was used to estimate the mean difference in the timeadjusted Area Under Curve (AUC) between the two treatment groups, with covariates for baseline scores and stratification factors. To test the treatment effect, a mixed linear model (random coefficient model) was used for the EQ-5D VAS score. Statistical tests were performed with a 2 sided type I error of 5%.||4.159|1.797|<0.0001
72404179|NCT00692770|144314984|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.1|||<|0.0001|TWO_SIDED|95.0|3.5|6.7|||ANCOVA|||An ANCOVA model was used to estimate the mean difference in the timeadjusted AUC between the two treatment groups, with covariates for baseline scores and stratification factors. To test the treatment effect, a mixed linear model (random coefficient model) was used for the FACT-HEP score. Statistical tests were performed with a 2 sided type I error of 5%.||6.7|3.5|<0.0001
72404180|NCT00692770|144314985|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.5|||<|0.0001|TWO_SIDED|95.0|1.4|3.6|||ANCOVA|||An ANCOVA model was used to estimate the mean difference in the timeadjusted AUC between the two treatment groups, with covariates for baseline scores and stratification factors. To test the treatment effect, a mixed linear model (random coefficient model) was used for the FACT-G score. Statistical tests were performed with a 2 sided type I error of 5%.||3.6|1.4|<0.0001
72515980|NCT01763866|144562691|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|8.11|STANDARD_ERROR_OF_MEAN|2.37||0.017|TWO_SIDED|95.0|3.43|12.79||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||12.79|3.43|0.017
72515981|NCT01763866|144562691|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|6.67|STANDARD_ERROR_OF_MEAN|1.86||0.001|TWO_SIDED|95.0|3.0|10.34||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||10.34|3.00|0.001
72515982|NCT01763866|144562691|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|8.57|STANDARD_ERROR_OF_MEAN|2.36||0.006|TWO_SIDED|95.0|3.93|13.22||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||13.22|3.93|0.006
72515983|NCT01763866|144562691|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|3.95|STANDARD_ERROR_OF_MEAN|2.1||0.85|TWO_SIDED|95.0|-0.19|8.09||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||8.09|-0.19|0.85
72404181|NCT00692770|144314986|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.562|||||TWO_SIDED|95.0|1.241|1.965|||||Significance of the biomarker main effect (RFS) and its corresponding hazard ratio estimate (HR) with 95% CI were reported. HR was expressed as high/low biomarker levels.|||1.965|1.241|
72404182|NCT00692770|144314987|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.747|||||TWO_SIDED|95.0|1.407|2.17|||||Significance of the biomarker main effect (RFS) and its corresponding hazard ratio estimate (HR) with 95% CI were reported. HR was expressed as high/low biomarker levels.|||2.170|1.407|
72404183|NCT00692770|144314988|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.56|||||TWO_SIDED|95.0|1.206|2.018|||||Significance of the biomarker main effect (RFS) and its corresponding hazard ratio estimate (HR) with 95% CI were reported. HR was expressed as high/low biomarker levels.|||2.018|1.206|
72515984|NCT01763866|144562691|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|9.13|STANDARD_ERROR_OF_MEAN|2.26|<|0.001|TWO_SIDED|95.0|4.68|13.58||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||13.58|4.68|<0.001
72488910|NCT01147744|144506091|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.104||||0.066|TWO_SIDED|95.0|-0.01|0.22||The study type I error rate was controlled at 5% level for primary efficacy analyses using the Week 8 trough FEV1 endpoint, by performing statistical tests of GSK2190915 versus placebo, sequentially from highest dose (300 mg) to lowest dose (10 mg).|ANCOVA|ANCOVA model used with covariates of Baseline trough FEV1, age, gender, country and smoking status. The LOCF method used to impute missing data.||||0.22|-0.01|0.066
72488911|NCT01147744|144506091|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.069||||0.224|TWO_SIDED|95.0|-0.04|0.18||The study type I error rate was controlled at 5% level for primary efficacy analyses using the Week 8 trough FEV1 endpoint, by performing statistical tests of GSK2190915 versus placebo, sequentially from highest dose (300 mg) to lowest dose (10 mg).|ANCOVA|ANCOVA model used with covariates of Baseline trough FEV1, age, gender, country and smoking status. The LOCF method used to impute missing data.||||0.18|-0.04|0.224
72488912|NCT01147744|144506091|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.062||||0.271|TWO_SIDED|95.0|-0.05|0.17||The study type I error rate was controlled at 5% level for primary efficacy analyses using the Week 8 trough FEV1 endpoint, by performing statistical tests of GSK2190915 versus placebo, sequentially from highest dose (300 mg) to lowest dose (10 mg).|ANCOVA|ANCOVA model used with covariates of Baseline trough FEV1, age, gender, country and smoking status. The LOCF method used to impute missing data.||||0.17|-0.05|0.271
72488913|NCT01147744|144506091|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.189|||<|0.001|TWO_SIDED|95.0|0.08|0.3||The study type I error rate was controlled at 5% level for primary efficacy analyses using the Week 8 trough FEV1 endpoint, by performing statistical tests of GSK2190915 versus placebo, sequentially from highest dose (300 mg) to lowest dose (10 mg).|ANCOVA|ANCOVA model used with covariates of Baseline trough FEV1, age, gender, country and smoking status. The LOCF method used to impute missing data.||||0.30|0.08|<0.001
72488914|NCT01147744|144506091|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.07||||0.22|TWO_SIDED|95.0|-0.04|0.18||The study type I error rate was controlled at 5% level for primary efficacy analyses using the Week 8 trough FEV1 endpoint, by performing statistical tests of GSK2190915 versus placebo, sequentially from highest dose (300 mg) to lowest dose (10 mg).|ANCOVA|ANCOVA model used with covariates of Baseline trough FEV1, age, gender, country and smoking status. The LOCF method used to impute missing data.||||0.18|-0.04|0.220
72488915|NCT01147744|144506092|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.385||||0.932|TWO_SIDED|95.0|-9.25|8.48|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline trough PM PEF, age, gender, country and smoking status.||||8.48|-9.25|0.932
72488916|NCT01147744|144506092|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.367||||0.762|TWO_SIDED|95.0|-7.5|10.23|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline trough PM PEF, age, gender, country and smoking status.||||10.23|-7.50|0.762
72404184|NCT02818218|144314994|SUPERIORITY||correlation coefficient|0.0005||||0.944|TWO_SIDED|98.3|-0.161|0.17|||Repeated measures correlation (rmcorr)||The repeated measures correlation coefficient (r\_rm) was calculated to assess the association between SVC and CVP. It ranges from -1 to +1, with values closer to +1 indicating that increases in SVC are associated with increases in CVP, and vice versa|||0.170|-0.161|0.944
72488917|NCT01147744|144506092|SUPERIORITY_OR_OTHER||Median Difference (Net)|-1.798||||0.689|TWO_SIDED|95.0|-10.62|7.03|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline trough PM PEF, age, gender, country and smoking status.||||7.03|-10.62|0.689
72488918|NCT01147744|144506092|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.321||||0.605|TWO_SIDED|95.0|-6.49|11.13|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline trough PM PEF, age, gender, country and smoking status.||||11.13|-6.49|0.605
72488919|NCT01147744|144506092|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.46||||0.584|TWO_SIDED|95.0|-6.36|11.28|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline trough PM PEF, age, gender, country and smoking status.||||11.28|-6.36|0.584
72488920|NCT01147744|144506092|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.529||||0.907|TWO_SIDED|95.0|-8.4|9.45|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline trough PM PEF, age, gender, country and smoking status.||||9.45|-8.40|0.907
72488921|NCT01147744|144506093|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.463||||0.753|TWO_SIDED|95.0|-7.65|10.58|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline trough PM PEF, age, gender, country and smoking status.||||10.58|-7.65|0.753
72488922|NCT01147744|144506093|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.75||||0.419|TWO_SIDED|95.0|-5.36|12.87|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline trough PM PEF, age, gender, country and smoking status.||||12.87|-5.36|0.419
72488923|NCT01147744|144506093|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.046||||0.51|TWO_SIDED|95.0|-12.12|6.03|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline trough PM PEF, age, gender, country and smoking status.||||6.03|-12.12|0.510
72515985|NCT01763866|144562691|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|7.57|STANDARD_ERROR_OF_MEAN|2.06||0.003|TWO_SIDED|95.0|3.51|11.64||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||11.64|3.51|0.003
72488924|NCT01147744|144506093|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.585||||0.32|TWO_SIDED|95.0|-4.47|13.64|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline trough PM PEF, age, gender, country and smoking status.||||13.64|-4.47|0.320
72488925|NCT01147744|144506093|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.484||||0.452|TWO_SIDED|95.0|-5.61|12.58|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline trough PM PEF, age, gender, country and smoking status.||||12.58|-5.61|0.452
72488926|NCT01147744|144506093|SUPERIORITY_OR_OTHER||Mean Difference (Net)|5.615||||0.229|TWO_SIDED|95.0|-3.55|14.78|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline trough PM PEF, age, gender, country and smoking status.||||14.78|-3.55|0.229
72488927|NCT01147744|144506094|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.169||||0.771|TWO_SIDED|95.0|-6.73|9.07|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.||||9.07|-6.73|0.771
72488928|NCT01147744|144506094|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.56||||0.257|TWO_SIDED|95.0|-3.33|12.45|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.||||12.45|-3.33|0.257
72404185|NCT02818218|144314995|SUPERIORITY||correlation coefficient|0.27|||<|0.001|TWO_SIDED|98.3|0.11|0.42|||Repeated measures correlation (rmcorr)||The repeated measures correlation coefficient (r\_rm) was calculated to assess the association between SVC and CVP. It ranges from -1 to +1, with values closer to +1 indicating that increases in SVC are associated with increases in CVP, and vice versa|||0.42|0.11|<0.001
72404186|NCT02818218|144314996|SUPERIORITY||correlation coefficient|0.34|||<|0.001|TWO_SIDED|98.3|0.19|0.48|||Repeated measures correlation (rmcorr)||The repeated measures correlation coefficient (r\_rm) was calculated to assess the association between SVC and CVP. It ranges from -1 to +1, with values closer to +1 indicating that increases in SVC are associated with increases in CVP, and vice versa|||0.48|0.19|<0.001
72404187|NCT02818218|144314998|SUPERIORITY||correlation coefficient|0.07||||0.298|TWO_SIDED|98.3|-0.1|0.24|||Repeated measures correlation (rmcorr)||The repeated measures correlation coefficient (r\_rm) was calculated to assess the association between SVC and CI. It ranges from -1 to +1, with values closer to +1 indicating that increases in SVC are associated with increases in CI, and vice versa|||0.24|-0.10|0.298
72488929|NCT01147744|144506094|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.326||||0.741|TWO_SIDED|95.0|-6.54|9.19|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.||||9.19|-6.54|0.741
72488930|NCT01147744|144506094|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.083||||0.983|TWO_SIDED|95.0|-7.76|7.93|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.||||7.93|-7.76|0.983
72488931|NCT01147744|144506094|SUPERIORITY_OR_OTHER||Mean Difference (Net)|8.204||||0.041|TWO_SIDED|95.0|0.34|16.07|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.||||16.07|0.34|0.041
72488932|NCT01147744|144506094|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.891||||0.475|TWO_SIDED|95.0|-5.05|10.83|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.||||10.83|-5.05|0.475
72488933|NCT01147744|144506095|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.837||||0.838|TWO_SIDED|95.0|-7.22|8.89|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.||||8.89|-7.22|0.838
72488934|NCT01147744|144506095|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.715||||0.508|TWO_SIDED|95.0|-5.33|10.76|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.||||10.76|-5.33|0.508
72488935|NCT01147744|144506095|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.124||||0.603|TWO_SIDED|95.0|-5.9|10.14|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.||||10.14|-5.90|0.603
72515986|NCT01763866|144562691|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|8.35|STANDARD_ERROR_OF_MEAN|2.28||0.003|TWO_SIDED|95.0|3.86|12.84||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||12.84|3.86|0.003
72515987|NCT01763866|144562691|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|5.36|STANDARD_ERROR_OF_MEAN|1.87|<|0.001|TWO_SIDED|95.0|1.68|9.04||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||9.04|1.68|<0.001
72568558|NCT04168190|144668499|NON_INFERIORITY|Non-inferiority can be concluded if the lower bound of the 95% CI for the estimated GMT ratio (V116/PPSV23) is \>0.33 (1-sided p-value \<0.025).|GMT Ratio|1.84|||<|0.001|TWO_SIDED|95.0|1.43|2.36|||P-value is estimated from a cLDA model.||Phase 2: V116/Phase 2: Pneumovax™23|Serotype 20A. Geometric mean titer (GMT) ratio and 95% confidence interval (CI), and p-value are estimated from a constrained longitudinal data analysis (cLDA) model.||2.36|1.43|<0.001
72404188|NCT02818218|144314999|SUPERIORITY||correlation coefficient|0.22||||0.002|TWO_SIDED|98.3|0.05|0.37|||Repeated measures correlation (rmcorr)||The repeated measures correlation coefficient (r\_rm) was calculated to assess the association between SVC and CI. It ranges from -1 to +1, with values closer to +1 indicating that increases in SVC are associated with increases in CI, and vice versa|||0.37|0.05|0.002
72488936|NCT01147744|144506095|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|-1.781||||0.662|TWO_SIDED|95.0|-9.78|6.22|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.||||6.22|-9.78|0.662
72488937|NCT01147744|144506095|SUPERIORITY_OR_OTHER||Mean Difference (Net)|5.949||||0.146|TWO_SIDED|95.0|-2.08|13.98|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.||||13.98|-2.08|0.146
72488938|NCT01147744|144506095|SUPERIORITY_OR_OTHER||Mean Difference (Net)|5.394||||0.191|TWO_SIDED|95.0|-2.69|13.48|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.||||13.48|-2.69|0.191
72488939|NCT01147744|144506096|SUPERIORITY_OR_OTHER||Mean Difference (Net)|6.106||||0.164|TWO_SIDED|95.0|-2.5|14.71|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.||||14.71|-2.50|0.164
72488940|NCT01147744|144506096|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.106||||0.349||95.0|-4.49|12.7|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.||||12.70|-4.49|0.349
72488941|NCT01147744|144506096|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.148||||0.623|TWO_SIDED|95.0|-6.42|10.72|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.||||10.72|-6.42|0.623
72568559|NCT04168190|144668500|SUPERIORITY|Superiority can be concluded if the lower bound of the 95% CI for the estimated GMT ratio (V116/PPSV23) is \>1.0 (1-sided p-value \<0.025).|GMT Ratio|6.03|||<|0.001|TWO_SIDED|95.0|4.23|8.62|||P-value is estimated from a cLDA model.||Phase 2: V116/Phase 2: Pneumovax™23|Serotype 6A. Geometric mean titer (GMT) ratio and 95% confidence interval (CI), and p-value are estimated from a constrained longitudinal data analysis (cLDA) model.||8.62|4.23|<0.001
72488942|NCT01147744|144506096|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.713||||0.694|TWO_SIDED|95.0|-6.84|10.26|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.||||10.26|-6.84|0.694
72624337|NCT00863304|144778629|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.81|STANDARD_ERROR_OF_MEAN|0.24|<|0.001|TWO_SIDED|95.0|-1.29|-0.34||P-value was based on pairwise comparisons.|ANCOVA|||Week 16: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.34|-1.29|<0.001
72488943|NCT01147744|144506096|SUPERIORITY_OR_OTHER||Mean Difference (Net)|9.592||||0.028|TWO_SIDED|95.0|1.03|18.15|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.||||18.15|1.03|0.028
72488944|NCT01147744|144506096|SUPERIORITY_OR_OTHER||Mean Difference (Net)|6.75||||0.125|TWO_SIDED|95.0|-1.89|15.38|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.||||15.38|-1.89|0.125
72488945|NCT01147744|144506097|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.346||||0.585|TWO_SIDED|95.0|-6.09|10.78|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.||||10.78|-6.09|0.585
72488946|NCT01147744|144506097|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.431||||0.92|TWO_SIDED|95.0|-8.0|8.86|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.||||8.86|-8.00|0.920
72488947|NCT01147744|144506097|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.702||||0.528|TWO_SIDED|95.0|-5.7|11.11|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.||||11.11|-5.70|0.528
72488948|NCT01147744|144506097|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.218||||0.776|TWO_SIDED|95.0|-9.6|7.17|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.||||7.17|-9.60|0.776
72488949|NCT01147744|144506097|SUPERIORITY_OR_OTHER||Mean Difference (Net)|7.49||||0.081|TWO_SIDED|95.0|-0.92|15.9|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.||||15.90|-0.92|0.081
72488950|NCT01147744|144506097|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.611||||0.403|TWO_SIDED|95.0|-4.87|12.09|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.||||12.09|-4.87|0.403
72488951|NCT01147744|144506098|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.005||||0.951|TWO_SIDED|95.0|-0.17|0.16|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.||||0.16|-0.17|0.951
72488952|NCT01147744|144506098|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.166||||0.043|TWO_SIDED|95.0|-0.33|-0.01|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.||||-0.01|-0.33|0.043
72515988|NCT01763866|144562691|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|8.66|STANDARD_ERROR_OF_MEAN|3.11||0.01|TWO_SIDED|95.0|2.51|14.8||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||14.80|2.51|0.010
72488953|NCT01147744|144506098|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.028||||0.734|TWO_SIDED|95.0|-0.19|0.13|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.||||0.13|-0.19|0.734
72515989|NCT01763866|144562691|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|5.46|STANDARD_ERROR_OF_MEAN|1.91||0.013|TWO_SIDED|95.0|1.69|9.23||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||9.23|1.69|0.013
72515990|NCT01763866|144562691|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|6.75|STANDARD_ERROR_OF_MEAN|2.2||0.002|TWO_SIDED|95.0|2.4|11.1||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||11.10|2.40|0.002
72515991|NCT01763866|144562691|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|10.23|STANDARD_ERROR_OF_MEAN|2.58|<|0.001|TWO_SIDED|95.0|5.13|15.32||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||15.32|5.13|<0.001
72488954|NCT01147744|144506098|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.003||||0.972|TWO_SIDED|95.0|-0.16|0.16|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.||||0.16|-0.16|0.972
72488955|NCT01147744|144506098|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.097||||0.238|TWO_SIDED|95.0|-0.26|0.06|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.||||0.06|-0.26|0.238
72515992|NCT01763866|144562691|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|8.85|STANDARD_ERROR_OF_MEAN|2.09|<|0.001|TWO_SIDED|95.0|4.73|12.97||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit||||12.97|4.73|<0.001
72568560|NCT04168190|144668500|SUPERIORITY|Superiority can be concluded if the lower bound of the 95% CI for the estimated GMT ratio (V116/PPSV23) is \>1.0 (1-sided p-value \<0.025).|GMT Ratio|6.8|||<|0.001|TWO_SIDED|95.0|5.37|8.62|||P-value is estimated from a cLDA model.||Phase 2: V116/Phase 2: Pneumovax™23|Serotype 15A. Geometric mean titer (GMT) ratio and 95% confidence interval (CI), and p-value are estimated from a constrained longitudinal data analysis (cLDA) model.||8.62|5.37|<0.001
72624338|NCT00863304|144778629|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.63|STANDARD_ERROR_OF_MEAN|0.24||0.009|TWO_SIDED|95.0|-1.11|-0.16||P-value was based on pairwise comparisons.|ANCOVA|||Week 16: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.16|-1.11|0.009
72624339|NCT00863304|144778630|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.08||0.012|TWO_SIDED|95.0|-0.35|-0.04||P-value was based on pairwise comparisons.|ANCOVA|||Week 2: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.04|-0.35|0.012
72488956|NCT01147744|144506098|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.075||||0.36|TWO_SIDED|95.0|-0.24|0.09|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.||||0.09|-0.24|0.360
72488957|NCT01147744|144506099|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.028||||0.692|TWO_SIDED|95.0|-0.11|0.17|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.||||0.17|-0.11|0.692
72488958|NCT01147744|144506099|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.096||||0.176|TWO_SIDED|95.0|-0.24|0.04|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.||||0.04|-0.24|0.176
72488959|NCT01147744|144506099|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.021||||0.768|TWO_SIDED|95.0|-0.16|0.12|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.||||0.12|-0.16|0.768
72515993|NCT01763866|144562692|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|6.83|STANDARD_ERROR_OF_MEAN|2.11||0.034|TWO_SIDED|95.0|2.66|10.99||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||10.99|2.66|0.034
72515994|NCT01763866|144562692|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|7.87|STANDARD_ERROR_OF_MEAN|2.46||0.017|TWO_SIDED|95.0|3.01|12.73||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||12.73|3.01|0.017
72515995|NCT01763866|144562692|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|8.81|STANDARD_ERROR_OF_MEAN|2.14||0.001|TWO_SIDED|95.0|4.58|13.03||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||13.03|4.58|0.001
72515996|NCT01763866|144562692|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|8.28|STANDARD_ERROR_OF_MEAN|2.45||0.006|TWO_SIDED|95.0|3.46|13.11||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||13.11|3.46|0.006
72515997|NCT01763866|144562692|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|4.07|STANDARD_ERROR_OF_MEAN|2.28||0.85|TWO_SIDED|95.0|-0.42|8.57||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||8.57|-0.42|0.85
72515998|NCT01763866|144562692|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|7.05|STANDARD_ERROR_OF_MEAN|2.45|<|0.001|TWO_SIDED|95.0|2.22|11.89||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||11.89|2.22|<0.001
72488960|NCT01147744|144506099|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.01||||0.887|TWO_SIDED|95.0|-0.13|0.15|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.||||0.15|-0.13|0.887
72488961|NCT01147744|144506099|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.051||||0.471|TWO_SIDED|95.0|-0.19|0.09|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.||||0.09|-0.19|0.471
72488962|NCT01147744|144506099|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.083||||0.248|TWO_SIDED|95.0|-0.22|0.06|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.||||0.06|-0.22|0.248
72488963|NCT01147744|144506100|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.131||||0.209|TWO_SIDED|95.0|-0.33|0.07|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.||||0.07|-0.33|0.209
72488964|NCT01147744|144506100|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.264||||0.011|TWO_SIDED|95.0|-0.47|-0.06|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.||||-0.06|-0.47|0.011
72488965|NCT01147744|144506100|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.076||||0.464|TWO_SIDED|95.0|-0.28|0.13|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.||||0.13|-0.28|0.464
72488966|NCT01147744|144506100|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.045||||0.662|TWO_SIDED|95.0|-0.25|0.16|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.||||0.16|-0.25|0.662
72488967|NCT01147744|144506100|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.245||||0.018|TWO_SIDED|95.0|-0.45|-0.04|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.||||-0.04|-0.45|0.018
72488968|NCT01147744|144506100|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.207||||0.047|TWO_SIDED|95.0|-0.41|0.0|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.||||-0.00|-0.41|0.047
72488969|NCT01147744|144506101|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.098||||0.3|TWO_SIDED|95.0|-0.28|0.09|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.||||0.09|-0.28|0.300
72488970|NCT01147744|144506101|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.138||||0.145|TWO_SIDED|95.0|-0.32|0.05|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.||||0.05|-0.32|0.145
72515999|NCT01763866|144562692|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|8.47|STANDARD_ERROR_OF_MEAN|2.23||0.003|TWO_SIDED|95.0|4.07|12.87||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||12.87|4.07|0.003
72516000|NCT01763866|144562692|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|7.14|STANDARD_ERROR_OF_MEAN|2.46||0.003|TWO_SIDED|95.0|2.29|11.99||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||11.99|2.29|0.003
72488971|NCT01147744|144506101|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.123||||0.19|TWO_SIDED|95.0|-0.31|0.06|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.||||0.06|-0.31|0.190
72488972|NCT01147744|144506101|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.002||||0.98|TWO_SIDED|95.0|-0.19|0.18|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.||||0.18|-0.19|0.980
72488973|NCT01147744|144506101|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.171||||0.07|TWO_SIDED|95.0|-0.36|0.01|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.||||0.01|-0.36|0.070
72404189|NCT02818218|144315000|SUPERIORITY||correlation coefficient|0.33|||<|0.001|TWO_SIDED|98.3|0.17|0.47|||Repeated measures correlation (rmcorr)||The repeated measures correlation coefficient (r\_rm) was calculated to assess the association between SVC and CI. It ranges from -1 to +1, with values closer to +1 indicating that increases in SVC are associated with increases in CI, and vice versa|||0.47|0.17|<0.001
72404190|NCT03722017|144315010|SUPERIORITY||Risk Ratio (RR)|0.91||||0.006|TWO_SIDED|95.0|||||Mixed Models Analysis|||Statistical Analysis 1 applies to the Hospital Discharge Timepoint||||0.006
72404191|NCT03722017|144315010|SUPERIORITY||Risk Ratio (RR)|0.93||||0.11|TWO_SIDED|95.0|||||Mixed Models Analysis|||Statistical Analysis 2 applies to the SNF Discharge Timepoint||||0.110
72516001|NCT01763866|144562692|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|3.2|STANDARD_ERROR_OF_MEAN|2.3|<|0.001|TWO_SIDED|95.0|-1.33|7.73||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||7.73|-1.33|<0.001
72516002|NCT01763866|144562692|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|7.35|STANDARD_ERROR_OF_MEAN|3.23||0.01|TWO_SIDED|95.0|0.97|13.72||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||13.72|0.97|0.010
72404192|NCT03722017|144315010|SUPERIORITY||Risk Ratio (RR)|0.92||||0.06|TWO_SIDED|95.0|||||Mixed Models Analysis|||Statistical Analysis 3 applies to the 90 Day Follow-Up Timepoint||||0.060
72516003|NCT01763866|144562692|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|5.04|STANDARD_ERROR_OF_MEAN|2.29||0.013|TWO_SIDED|95.0|0.52|9.56||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||9.56|0.52|0.013
72516004|NCT01763866|144562692|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|4.84|STANDARD_ERROR_OF_MEAN|2.41||0.002|TWO_SIDED|95.0|0.07|9.6||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||9.60|0.07|0.002
72568561|NCT04168190|144668500|SUPERIORITY|Superiority can be concluded if the lower bound of the 95% CI for the estimated GMT ratio (V116/PPSV23) is \>1.0 (1-sided p-value \<0.025).|GMT Ratio|3.0|||<|0.001|TWO_SIDED|95.0|2.31|3.9|||P-value is estimated from a cLDA model.||Phase 2: V116/Phase 2: Pneumovax™23|Serotype 15C. Geometric mean titer (GMT) ratio and 95% confidence interval (CI), and p-value are estimated from a constrained longitudinal data analysis (cLDA) model.||3.90|2.31|<0.001
72624340|NCT00863304|144778630|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.08||0.113|TWO_SIDED|95.0|-0.28|0.03||P-value was based on pairwise comparisons.|ANCOVA|||Week 2: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||0.03|-0.28|0.113
72404193|NCT03722017|144315011|SUPERIORITY||Mean Difference (Net)|-0.049||||0.738|TWO_SIDED|95.0|||||Mixed Models Analysis|||Statistical Analysis 1 applies to the Hospital Discharge Timepoint||||0.738
72404194|NCT03722017|144315011|SUPERIORITY||Mean Difference (Net)|0.001||||0.995|TWO_SIDED|95.0|||||Mixed Models Analysis|||Statistical Analysis 2 applies to the SNF Discharge Timepoint||||0.995
72404195|NCT03722017|144315011|SUPERIORITY||Mean Difference (Net)|0.058||||0.721|TWO_SIDED|95.0|||||Mixed Models Analysis|||Statistical Analysis 3 applies to the 90 Day Follow Up Timepoint||||0.721
72488974|NCT01147744|144506101|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.158||||0.095|TWO_SIDED|95.0|-0.34|0.03|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.||||0.03|-0.34|0.095
72488975|NCT01147744|144506102|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||||||1.000
72404196|NCT03711162|144315014|SUPERIORITY||Least square (LS) mean difference|22.7|STANDARD_ERROR_OF_MEAN|38.12||0.5525|TWO_SIDED|95.0|-52.3|97.6||P-value: based on random coefficient regression model (linear slope model) on FVC values.|Coefficient Regression Model|Treatment effect determined by using estimated slopes for each treatment group on basis of time-by-treatment interaction term from the mixed model.||||97.6|-52.3|0.5525
72404197|NCT03711162|144315014|SUPERIORITY||LS mean difference|-26.7|STANDARD_ERROR_OF_MEAN|37.53||0.4776|TWO_SIDED|95.0|-100.5|47.1||P-value: based on random coefficient regression model (linear slope model) on FVC values.|Coefficient Regression Model|Treatment effect was determined by using estimated slopes for each treatment group on basis of time-by-treatment interaction term from mixed model.||||47.1|-100.5|0.4776
72516005|NCT01763866|144562692|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|9.78|STANDARD_ERROR_OF_MEAN|2.9|<|0.001|TWO_SIDED|95.0|4.05|15.51||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||15.51|4.05|<0.001
72516006|NCT01763866|144562692|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|9.06|STANDARD_ERROR_OF_MEAN|2.36|<|0.001|TWO_SIDED|95.0|4.4|13.72||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit||||13.72|4.40|<0.001
72404198|NCT03711162|144315015|SUPERIORITY||Odds Ratio (OR)|0.99||||0.9648|TWO_SIDED|95.0|0.56|1.74|||Regression, Logistic|||||1.74|0.56|0.9648
72488976|NCT01147744|144506102|SUPERIORITY_OR_OTHER|||||||0.814|||||||Fisher Exact|||||||0.814
72488977|NCT01147744|144506102|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||||||1.000
72488978|NCT01147744|144506102|SUPERIORITY_OR_OTHER|||||||0.828|||||||Fisher Exact|||||||0.828
72488979|NCT01147744|144506102|SUPERIORITY_OR_OTHER|||||||0.477|||||||Fisher Exact|||||||0.477
72488980|NCT01147744|144506102|SUPERIORITY_OR_OTHER|||||||0.46|||||||Fisher Exact|||||||0.460
72488981|NCT03302975|144506124|SUPERIORITY|||||||0.001|TWO_SIDED|95.0|||||ANOVA|||||||0.001
72488982|NCT00807742|144506131|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.22||||0.606|TWO_SIDED|95.0|0.57|2.63|||Chi-squared|||||2.63|0.57|.606
72488983|NCT00807742|144506132|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.81||||0.29|TWO_SIDED|95.0|0.57|2.63|||Chi-squared|||||2.63|0.57|.290
72488984|NCT00807742|144506133|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.03||||0.32|TWO_SIDED|95.0|0.49|8.23|||Chi-squared|||||8.23|0.49|.32
72488985|NCT00807742|144506134|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.08||||0.298|TWO_SIDED|95.0|0.51|8.45|||Chi-squared|||||8.45|0.51|.298
72488986|NCT00807742|144506135|SUPERIORITY||Effect Size d|-0.49|||<|0.001|TWO_SIDED|95.0|-0.71|-0.27|||t-test, 2 sided|||||-0.27|-0.71|<.001
72488987|NCT00807742|144506136|SUPERIORITY||Effect Size d|-0.15||||0.199|TWO_SIDED|95.0|-0.38|0.08|||t-test, 2 sided|||||0.08|-0.38|.199
72488988|NCT00807742|144506137|SUPERIORITY||Effect Size d|-0.12||||0.148|TWO_SIDED|95.0|-0.57|0.33|||t-test, 2 sided|||||0.33|-.57|.148
72488989|NCT00807742|144506138|SUPERIORITY||Effect Size d|-0.15||||0.249|TWO_SIDED|95.0|-0.4|0.11|||t-test, 2 sided|||||0.11|-0.40|.249
72488990|NCT00807742|144506139|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.48||||0.402|TWO_SIDED|95.0|0.59|3.72|||Chi-squared|||||3.72|0.59|0.402
72488991|NCT00807742|144506140|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.91||||0.772|TWO_SIDED|95.0|0.49|1.7|||Chi-squared|||||1.70|0.49|.772
72488992|NCT00807742|144506141|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.03||||0.91|TWO_SIDED|95.0|0.6|1.77|||Chi-squared|||||1.77|0.60|.910
72488993|NCT00807742|144506142|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.94||||0.812|TWO_SIDED|95.0|0.54|1.62|||Chi-squared|||||1.62|0.54|.812
72516007|NCT01669811|144562701|SUPERIORITY_OR_OTHER||Difference in proportions|23.8|||<|0.0001|TWO_SIDED|95.0|14.9|32.6||p-value is obtained using chi square method.|Chi-squared|95% CI is obtained using Newcombe-Wilson score method without continuity correction.||To evaluate the efficacy of D20 bid on healing of refractory RE in comparison with D20 qd||32.6|14.9|<0.0001
72516008|NCT01669811|144562702|SUPERIORITY_OR_OTHER||Difference in proportions|32.8|||<|0.0001|TWO_SIDED|95.0|21.9|42.6||p-value is obtained using chi square method.|Chi-squared|95% CI is obtained using Newcombe-Wilson score method without continuity correction.||To evaluate the efficacy of D20 bid on healing of refractory RE in comparison with D20 qd||42.6|21.9|<0.0001
72516009|NCT01669811|144562703|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.29||||0.1452|TWO_SIDED|95.0|0.91|1.83|||Log Rank|95% CI of the hazard ratio is obtained using Cox proportional hazards model including a factor of treatment group.||To evaluate the efficacy of D20 bid on gastroesophageal reflux disease (GERD) symptoms in comparison with D20 qd||1.83|0.91|0.1452
72488994|NCT00807742|144506143|SUPERIORITY||Odds Ratio (OR)|0.76||||0.49|TWO_SIDED|95.0|0.36|1.65|||Chi-squared|||||1.65|0.36|.490
72488995|NCT00807742|144506144|SUPERIORITY||Odds Ratio (OR)|1.19||||0.511|TWO_SIDED|95.0|0.67|2.06|||Chi-squared|||||2.06|0.67|.511
72488996|NCT00807742|144506145|SUPERIORITY||Odds Ratio (OR)|1.19||||0.499|TWO_SIDED|95.0|0.72|1.97|||Chi-squared|||||1.97|0.72|.499
72488997|NCT00807742|144506146|SUPERIORITY||Odds Ratio (OR)|0.96||||0.876|TWO_SIDED|95.0|0.58|1.6|||Chi-squared|||||1.60|0.58|.876
72488998|NCT00807742|144506147|SUPERIORITY_OR_OTHER||Effect Size d|-0.37||||0.001|TWO_SIDED|95.0|-0.59|-0.15|||t-test, 2 sided|||||-0.15|-0.59|.001
72488999|NCT00807742|144506148|SUPERIORITY_OR_OTHER||Effect Size d|-0.25||||0.069|TWO_SIDED|95.0|-0.46|0.02|||t-test, 2 sided|||||0.02|-0.46|.069
72489000|NCT00807742|144506149|SUPERIORITY_OR_OTHER||Effect Size d|-0.16||||0.202|TWO_SIDED|95.0|-0.4|0.08|||t-test, 2 sided|||||0.08|-0.40|.202
72489001|NCT00807742|144506150|SUPERIORITY_OR_OTHER||Effect Size d|-0.17||||0.199|TWO_SIDED|95.0|-0.42|0.09|||t-test, 2 sided|||||0.09|-0.42|.199
72489002|NCT00492752|144506151|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.6783||||0.014144||95.0|0.4962|0.9272|||Log Rank||Hazard ratio is for Sorafenib vs placebo.|||0.9272|0.4962|0.014144
72489003|NCT00492752|144506151|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.6208||||0.003464||95.0|0.4498|0.8568|||Log Rank|log rank test stratified by country, tumor burden, and ECOG.|Hazard ratio is for Sorafenib vs placebo|||0.8568|0.4498|0.003464
72489004|NCT00492752|144506152|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.9032||||0.497537||95.0|0.6705|1.2165|||Log Rank||Hazard ratio is for Sorafenib vs placebo.|||1.2165|0.6705|0.497537
72489005|NCT00492752|144506152|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.8831||||0.437926||95.0|0.6449|1.2093|||Log Rank|log rank test stratified by country, tumor burden, and ECOG.|Hazard ratio is for Sorafenib vs placebo|||1.2093|0.6449|0.437926
72489006|NCT00492752|144506153|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.5744||||0.000537||95.0|0.4154|0.7942|||Log Rank||Hazard ratio is for Sorafenib vs placebo|||0.7942|0.4154|0.000537
72489007|NCT00492752|144506153|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.5375||||0.00054||95.0|0.3763|0.7677|||Log Rank|log rank test stratified by country, tumor burden, and ECOG.|Hazard ratio is for Sorafenib vs placebo|||0.7677|0.3763|0.000540
72489008|NCT00492752|144506154|SUPERIORITY_OR_OTHER||Disease control rate|0.3533||||||95.0|0.2771|0.4355||||||||0.4355|0.2771|
72489009|NCT00492752|144506154|SUPERIORITY_OR_OTHER||Disease control rate|0.1579||||||95.0|0.0843|0.2596||||||||0.2596|0.0843|
72489010|NCT00492752|144506157|SUPERIORITY_OR_OTHER|||||||0.67|||||||Fisher Exact|based on tumor response rate (CR+PR)||||||0.67
72489011|NCT02258451|144506174|SUPERIORITY||Hazard Ratio (HR)|0.891||||0.4843|TWO_SIDED|80.0|0.72|1.102||1-sided SSE-FS hypotheses were tested using a log-rank test with a 2-sided alpha of 0.2, stratified by the randomization stratification factors.|Log Rank||The hazard ratio (radium-223 dichloride / placebo) for SSE-FS was calculated using Cox Proportional Hazards Model, stratified by the same stratification factors as randomization.|The 1-sided null hypothesis that treatment with radium-223 dichloride does not result in superior SSE-FS to treatment with placebo in participant population was tested against the 1-sided alternative hypothesis that the treatment with radium-223 dichloride results in superior SSE-FS time to treatment the placebo. H0: SSE-FS Radium-223+Exemestane/Everolimus \<= SSE-FS Placebo+Exemestane/Everolimus, versus HA: SSE-FSRadium-223+Exemestane/Everolimus \> SSE-FS Placebo+Exemestane/Everolimus||1.102|0.720|0.4843
72489012|NCT02258451|144506175|SUPERIORITY||Hazard Ratio (HR)|0.968||||0.8438|TWO_SIDED|95.0|0.697|1.343||P-value was calculated using a 2-sided log-rank test stratified by the same stratification factors as randomization. No alpha adjustment for multiplicity was applied.|Log Rank||The hazard ratio (radium-223 dichloride / placebo) was calculated using Cox Proportional Hazards Model , stratified by the same stratification factors as randomization.|||1.343|0.697|0.8438
72404199|NCT03711162|144315015|SUPERIORITY||Odds Ratio (OR)|1.05||||0.853|TWO_SIDED|95.0|0.6|1.84|||Regression, Logistic|||||1.84|0.60|0.8530
72489013|NCT02258451|144506176|SUPERIORITY||Hazard Ratio (HR)|0.962||||0.8811|TWO_SIDED|95.0|0.577|1.604||P-value was calculated using a 2-sided log-rank test stratified by the same stratification factors as randomization. No alpha adjustment for multiplicity was applied.|Log Rank||The hazard ratio (radium-223 dichloride / placebo) was calculated using Cox Proportional Hazards Model , stratified by the same stratification factors as randomization.|||1.604|0.577|0.8811
72489014|NCT02258451|144506177|SUPERIORITY||Hazard Ratio (HR)|0.928||||0.6537|TWO_SIDED|95.0|0.667|1.289||P-value was calculated using a 2-sided log-rank test stratified by the same stratification factors as randomization. No alpha adjustment for multiplicity was applied.|Log Rank||The hazard ratio (radium-223 dichloride / placebo) was calculated using Cox Proportional Hazards Model , stratified by the same stratification factors as randomization.|Participants with baseline WPS \> 8 were included in the analysis population but censored at Day 1.||1.289|0.667|0.6537
72489015|NCT02258451|144506178|SUPERIORITY||Hazard Ratio (HR)|0.884||||0.4496|TWO_SIDED|95.0|0.641|1.219||P-value was calculated using a 2-sided log-rank test stratified by the same stratification factors as randomization. No alpha adjustment for multiplicity was applied.|Log Rank||The hazard ratio (radium-223 dichloride / placebo) was calculated using Cox Proportional Hazards Model , stratified by the same stratification factors as randomization.|||1.219|0.641|0.4496
72489016|NCT02258451|144506179|SUPERIORITY||Hazard Ratio (HR)|0.874||||0.3467|TWO_SIDED|95.0|0.66|1.157||P-value was calculated using a 2-sided log-rank test stratified by the same stratification factors as randomization. No alpha adjustment for multiplicity was applied.|Log Rank||The hazard ratio (radium-223 dichloride / placebo) was calculated using Cox Proportional Hazards Model , stratified by the same stratification factors as randomization.|||1.157|0.660|0.3467
72489017|NCT02258451|144506180|SUPERIORITY||Risk Difference (RD)|4.1||||0.556|TWO_SIDED|95.0|-10.2|18.4||P-value was calculated using a 2-sided Cochran-Mantel-Haenszel test stratified by the same stratification factors as randomization. No alpha adjustment for multiplicity was applied.|Cochran-Mantel-Haenszel|||||18.4|-10.2|0.556
72489018|NCT03834519|144506199|SUPERIORITY||Hazard Ratio (HR)|0.94||||0.2616|TWO_SIDED|95.0|0.77|1.14|||Log Rank|One-sided p-value based on log-rank test stratified by measurable disease status and prior NHA treatment.|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by measurable disease status and prior NHA treatment.|Treatment difference in survival assessed by the stratified log-rank test stratified by measurable disease status and prior NHA treatment.||1.14|0.77|0.2616
72489019|NCT03834519|144506200|SUPERIORITY||Hazard Ratio (HR)|1.02||||0.5544|TWO_SIDED|95.0|0.82|1.25|||Log Rank|One-sided p-value based on log-rank test stratified by measurable disease status and prior NHA treatment.|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by measurable disease status and prior NHA treatment.|Treatment difference in rPFS assessed by the stratified log-rank test stratified by measurable disease status and prior NHA treatment.||1.25|0.82|0.5544
72489020|NCT03834519|144506201|OTHER|Treatment difference in TFST|Hazard Ratio (HR)|0.86||||||95.0|0.71|1.03|||||Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by measurable disease status and prior NHA treatment.|||1.03|0.71|
72489021|NCT03834519|144506202|OTHER|Treatment difference in ORR|Difference in percentage|10.9|||||TWO_SIDED|95.0|4.0|17.1||||||||17.1|4.0|
72516010|NCT01669811|144562704|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.46||||0.0837|TWO_SIDED|95.0|0.97|2.18|||Log Rank|95% CI of the hazard ratio is obtained using Cox proportional hazards model including a factor of treatment group.||To evaluate the efficacy of D20 bid on gastroesophageal reflux disease (GERD) symptoms in comparison with D20 qd||2.18|0.97|0.0837
72404200|NCT03711162|144315016|SUPERIORITY||Hazard Ratio (HR)|1.01|||||TWO_SIDED|95.0|0.5|2.05|||||Hazard ratio and 95% confidence interval originated from a Cox proportional hazards for time to respiratory-related hospitalization.|||2.05|0.50|
72489022|NCT03834519|144506204|OTHER|Treatment difference in time to PSA progression|Hazard Ratio (HR)|1.11|||||TWO_SIDED|95.0|0.89|1.38|||||Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by measurable disease status and prior NHA treatment.|||1.38|0.89|
72489023|NCT03834519|144506205|OTHER|Treatment difference in SSRE|Hazard Ratio (HR)|0.54|||||TWO_SIDED|95.0|0.38|0.78|||||Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by measurable disease status and prior NHA treatment.|||0.78|0.38|
72489024|NCT03834519|144506206|OTHER|Treatment difference in time to radiographic soft tissue progression|Hazard Ratio (HR)|0.79|||||TWO_SIDED|95.0|0.62|1.0|||||Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by measurable disease status and prior NHA treatment.|||1.00|0.62|
72489025|NCT03834519|144506207|OTHER|Treatment difference in TTPE|Hazard Ratio (HR)|0.95||||0.3643|TWO_SIDED|95.0|0.72|1.26|||Log Rank||Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by measurable disease status and prior NHA treatment.|||1.26|0.72|0.3643
72489026|NCT00346073|144506230|NON_INFERIORITY|The primary objective of non-inferiority was met if the lower limit of the 95% confidence intervals (CIs), between the two groups (Boostrix Group - Adacel Group) were greater than or equal to (≥) -10%|Difference in percentage|-0.43|||||TWO_SIDED|95.0|-1.47|0.84||||||The non-inferiority of Boostrix® vaccine compared to Adacel™ vaccine, with respect to the percentage of subjects with anti-diphtheria (anti-D) antibody concentrations greater than or equal to (≥) 0.1 IU/mL, one month after vaccination.||0.84|-1.47|
72489027|NCT00346073|144506230|NON_INFERIORITY|The primary objective of non-inferiority was met if the lower limit of the 95% confidence intervals (CIs), between the two groups (Boostrix Group - Adacel Group) were greater than or equal to (≥) -10%|Difference in percentage|-0.42|||||TWO_SIDED|95.0|-0.9|0.11||||||The non-inferiority of Boostrix® vaccine compared to Adacel™ vaccine, with respect to the percentage of subjects with anti-tetanus (anti-T) antibody concentrations greater than or equal to (≥) 0.1 IU/mL, one month after vaccination.||0.11|-0.9|
72489028|NCT00346073|144506231|NON_INFERIORITY|The primary objective of non-inferiority was met if the lower limit of the 95% confidence intervals (CIs), between the two groups (Boostrix Group - Adacel Group) were greater than or equal to (≥) -10%|Difference in percentage|-1.04|||||TWO_SIDED|95.0|-1.97|0.0||||||The non-inferiority of Boostrix® vaccine compared to Adacel™ vaccine, with respect to the percentage of subjects with anti-tetanus (anti-T) antibody concentrations greater than or equal to (≥) 1.0 IU/mL, one month after vaccination.||0|-1.97|
72489029|NCT00346073|144506233|SUPERIORITY||Booster response|77.2|||||TWO_SIDED|95.0|74.9|79.3||||||"Demonstration that anti-PT booster response occurred in at least 80% of adults receiving a single dose of Boostrix® vaccine, one month after vaccination.~Criterion for evaluation: one month after vaccination, the lower limit of the 95% confidence interval (CI) for the percentage of subjects with a booster response was greater than or equal to (≥) 80%."||79.3|74.9|
72404201|NCT03711162|144315016|SUPERIORITY||Hazard Ratio (HR)|0.93|||||TWO_SIDED|95.0|0.47|1.88|||||Hazard ratio and 95% confidence interval originated from a Cox proportional hazards for time to respiratory-related hospitalization.|||1.88|0.47|
72489030|NCT00346073|144506233|SUPERIORITY||Booster response|96.9|||||TWO_SIDED|95.0|95.8|97.7||||||"Demonstration that anti-FHA booster response occurred in at least 80% of adults receiving a single dose of Boostrix® vaccine, one month after vaccination.~Criterion for evaluation: one month after vaccination, the lower limit of the 95% confidence interval (CI) for the percentage of subjects with a booster response was greater than or equal to (≥) 80%."||97.7|95.8|
72516011|NCT01669811|144562705|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.34||||0.2678|TWO_SIDED|95.0|0.8|2.26|||Log Rank|95% CI of the hazard ratio is obtained using Cox proportional hazards model including a factor of treatment group.||To evaluate the efficacy of D20 bid on gastroesophageal reflux disease (GERD) symptoms in comparison with D20 qd||2.26|0.80|0.2678
72516012|NCT01669811|144562706|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.15||||0.6389|TWO_SIDED|95.0|0.62|2.12|||Log Rank|95% CI of the hazard ratio is obtained using Cox proportional hazards model including a factor of treatment group.||To evaluate the efficacy of D20 bid on gastroesophageal reflux disease (GERD) symptoms in comparison with D20 qd||2.12|0.62|0.6389
72516013|NCT01669811|144562707|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.38||||0.4485|TWO_SIDED|95.0|0.8|2.38|||Log Rank|95% CI of the hazard ratio is obtained using Cox proportional hazards model including a factor of treatment group.||To evaluate the efficacy of D20 bid on gastroesophageal reflux disease (GERD) symptoms in comparison with D20 qd||2.38|0.80|0.4485
72516014|NCT03245723|144562708|OTHER|Descriptive statistics||||||0.38|||||||Wilcoxon Rank Sum test|||||||0.38
72516015|NCT03245723|144562709|OTHER|Descriptive statistics||||||0.12|||||||Wilcoxon Rank Sum test|||||||0.12
72516016|NCT00077376|144562710|SUPERIORITY_OR_OTHER||Objective response rate|41.0|||||TWO_SIDED|95.0|26.0|58.0||||||||58|26|
72404202|NCT03711162|144315017|SUPERIORITY||LS mean difference|-0.5||||0.785|TWO_SIDED|95.0|-4.4|3.3|||Mixed Models Analysis||LS mean difference (95% CI) per treatment group with treatment, time (categorical), treatment-by-time interaction, stratum and baseline SGRQ total score as fixed effects and participant as random effect.|||3.3|-4.4|0.7850
72404203|NCT03711162|144315017|SUPERIORITY||LS mean difference|0.3||||0.8617|TWO_SIDED|95.0|-3.4|4.1|||Mixed Models Analysis||LS mean difference (95% CI) per treatment group with treatment, time (categorical), treatment-by-time interaction, stratum and baseline SGRQ total score as fixed effects and participant as random effect.|||4.1|-3.4|0.8617
72404204|NCT03711162|144315018|SUPERIORITY||LS Mean difference|19.4|STANDARD_ERROR_OF_MEAN|33.68|||TWO_SIDED|95.0|-46.9|85.7|||||The treatment effect was determined by using estimated slopes for each study group on the basis of the time-by-treatment interaction term from the mixed model.|||85.7|-46.9|
72489031|NCT00346073|144506233|SUPERIORITY||Booster response|93.2|||||TWO_SIDED|95.0|91.8|94.4||||||"Demonstration that anti-PRN booster response occurred in at least 80% of adults receiving a single dose of Boostrix® vaccine, one month after vaccination.~Criterion for evaluation: one month after vaccination, the lower limit of the 95% confidence interval (CI) for the percentage of subjects with a booster response was greater than or equal to (≥) 80%."||94.4|91.8|
72489032|NCT03670953|144506257|SUPERIORITY|2-sided at a significance level of alpha = 0.05|Least Squares Mean difference|0.53|STANDARD_ERROR_OF_MEAN|0.226||0.0194|TWO_SIDED|95.0|0.09|0.97||"LSM, SE, CI and p-value from a MMRM with CFB in Good on time as outcome, baseline Good on time as a covariate, treatment and visit as fixed effects, pooled center as random effect and a treatment-by-visit interaction."|MMRM|The degree-of-freedom of the denominator is estimated using the Kenward-Roger method. Unstructured covariance structure is assumed.||||0.97|0.09|0.0194
72516017|NCT00077376|144562711|SUPERIORITY_OR_OTHER||Objective response rate|44.0|||||TWO_SIDED|95.0|31.0|58.0||||||||58|31|
72516018|NCT03097614|144562782|SUPERIORITY|||||||0.0001|TWO_SIDED||||||ANCOVA|||||||0.0001
72516019|NCT02678312|144562800|SUPERIORITY||Cox Proportional Hazard|1.0655||||0.7958|TWO_SIDED|95.0|0.6589|1.7232||The adjusted hazard ratio and the p-values are based on a Cox proportional hazard model, stratified by modified age group with treatment and NYHA/ROSS class group included as factor.|Cox Proportional Hazard|||||1.7232|0.6589|0.7958
72404205|NCT03711162|144315018|SUPERIORITY||LS Mean difference|-29.1|STANDARD_ERROR_OF_MEAN|32.95|||TWO_SIDED|95.0|-93.9|35.8|||||The treatment effect was determined by using estimated slopes for each study group on the basis of the time-by-treatment interaction term from the mixed model.|||35.8|-93.9|
72404206|NCT03711162|144315019|SUPERIORITY||Odds Ratio (OR)|1.15|||||TWO_SIDED|95.0|0.68|1.95|||||Odds ratio and 95% confidence interval originated from a logistic regression.|||1.95|0.68|
72404207|NCT03711162|144315019|SUPERIORITY||Odds Ratio (OR)|1.25|||||TWO_SIDED|95.0|0.74|2.09|||||Odds ratio and 95% confidence interval originated from a logistic regression.|||2.09|0.74|
72516020|NCT00225147|144562928|SUPERIORITY_OR_OTHER|||||||0.001|||||||Log Rank|||||||0.001
72516021|NCT00225147|144562928|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Log Rank|||||||<0.001
72516022|NCT00225147|144562929|SUPERIORITY_OR_OTHER|||||||0.04||95.0|||||Log Rank|||||||0.040
72516023|NCT00225147|144562929|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Log Rank|||||||<0.001
72516024|NCT00868166|144562965|SUPERIORITY|||||||0.71|||||||Stratified Log-Rank Test|||||||0.71
72516025|NCT00868166|144562966|SUPERIORITY|||||||0.83|||||||Stratified Log-Rank Test|||||||0.83
72516026|NCT00868166|144562966|SUPERIORITY|||||||0.73|||||||Non-stratified Log-Rank Test|||||||0.73
72516027|NCT00868166|144562968|SUPERIORITY|||||||0.21|||||||Stratified Log-Rank Test|||||||0.21
72516028|NCT00868166|144562968|SUPERIORITY|||||||0.2|||||||Non-stratified Log-Rank Test|||||||0.20
72516029|NCT00868166|144562970|SUPERIORITY|||||||0.56|||||||Stratified Log-Rank Test|||||||0.56
72489033|NCT03670953|144506258|SUPERIORITY|2-sided at a significance level of alpha = 0.05|Least Squares Mean difference|-0.48|STANDARD_ERROR_OF_MEAN|0.214||0.0252|TWO_SIDED|95.0|-0.9|-0.06||"LSM, SE, CI and p-value from a MMRM with CFB in Off time as outcome, baseline Off time as a covariate, treatment and visit as fixed effects, pooled center as random effect and a treatment-by-visit interaction."|MMRM|The degree-of-freedom of the denominator is estimated using the Kenward-Roger method. Unstructured covariance structure is assumed.||||-0.06|-0.90|0.0252
72489034|NCT03670953|144506259|SUPERIORITY|2-sided at a significance level of alpha = 0.05|Percent difference|10.9||||0.0015|TWO_SIDED|95.0|3.5|18.3||"P-value from the Cochran-Mantel-Haenszel test stratified by pooled center comparing the percentage of Much or Very Much Improved participants between the treatment groups."|Cochran-Mantel-Haenszel|||||18.3|3.5|0.0015
72489035|NCT03670953|144506260|SUPERIORITY|2-sided at a significance level of alpha = 0.05|Least Squares Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.89||0.9587|TWO_SIDED|95.0|-1.8|1.7||LSM, SE, CI and p-value from a MMRM with CFB in MDS-UPDRS Part III Score as outcome, baseline MDS-UPDRS Part III Score as a covariate, treatment and visit as fixed effects, pooled center as random effect and a treatment-by-visit interaction.|MMRM|The degree-of-freedom of the denominator is estimated using the Kenward-Roger method. Unstructured covariance structure is assumed.||||1.7|-1.8|0.9587
72489036|NCT03670953|144506261|SUPERIORITY|2-sided at a significance level of alpha = 0.05|Least Squares Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|1.11||0.9668|TWO_SIDED|95.0|-2.2|2.1||LSM, SE, CI \& p-value from MMRM with CFB in MDS-UPDRS Part II \& III Scores as outcome, baseline MDS-UPDRS Part II and III Scores as a covariate, treatment and visit as fixed effects, pooled center as random effect \& a treatment-by-visit interaction.|MMRM|The degree-of-freedom of the denominator is estimated using the Kenward-Roger method. Unstructured covariance structure is assumed.||||2.1|-2.2|0.9668
72489037|NCT02603120|144506262|NON_INFERIORITY|A sample size of 260 participants per treatment group would provide at least 90% power to detect a noninferiority margin of 4% in difference in percentage of participants with HIV-1 RNA ≥ 50 copies/mL at Wk 48, between B/F/TAF group and ABC/DTG/3TC group. Sample size was based on assumptions that both treatment groups have 2% of participants with HIV-1 RNA ≥ 50 copies/mL at Wk 48 and that the non-inferiority margin is 4%, and that the significance level of the test is at a one-sided 0.025 level.|Difference in Percentages|0.7|||||TWO_SIDED|95.002|-1.0|2.8|||||The differences in percentages of participants between treatment groups and their 95.002% CIs were calculated based on an unconditional exact method using 2 inverted 1-sided tests.|||2.8|-1.0|
72489038|NCT02603120|144506262|SUPERIORITY|||||||0.62|||||||Fisher Exact|||||||0.62
72489039|NCT02603120|144506263|NON_INFERIORITY|It would be concluded that B/F/TAF is noninferior to ABC/DTG/3TC if the lower bound of the 2-sided 95.002% CI of the difference between treatment groups (B/F/TAF group -ABC/DTG/3TC group) in the percentage of participants with HIV-1 RNA \< 50 copies/mL is greater than -10%.|Difference in Percentages|-1.4|||||TWO_SIDED|95.002|-5.5|2.6|||||The differences in percentages of participants between treatment groups and their 95.002% CIs were calculated based on an unconditional exact method using 2 inverted 1-sided tests.|||2.6|-5.5|
72489040|NCT02603120|144506263|SUPERIORITY|||||||0.59|||||||Fisher Exact|||||||.59
72489041|NCT02603120|144506264|OTHER||Difference in least squares means|-35.0||||0.031|TWO_SIDED|95.0|-67.0|-3.0|||ANOVA|||||-3|-67|0.031
72489042|NCT02603120|144506266|OTHER||Difference in least squares means|0.276||||0.33|TWO_SIDED|95.0|-0.275|0.827|||ANOVA|||||0.827|-0.275|0.33
72404208|NCT03711162|144315020|SUPERIORITY||LS mean difference|3.7|||||TWO_SIDED|95.0|-11.5|19.0|||||The treatment effect was determined by using estimated least square mean difference between each active treatment group and placebo from the mixed model.|||19.0|-11.5|
72489043|NCT02603120|144506268|OTHER||Difference in least squares means|-0.143||||0.47|TWO_SIDED|95.0|-0.534|0.248|||ANOVA|||||0.248|-0.534|0.47
72489044|NCT03577730|144506307|OTHER||Median Difference (Final Values)|55.0||||0.092|TWO_SIDED|95.0|-9.0|118.0|||Generalized estimating equations||The median difference (+55) is an estimated difference between groups - rather than the actual difference - based on the pre-specified generalized estimated equations modeling.|||118|-9|0.092
72516030|NCT00074802|144562976|SUPERIORITY||Mean Difference (Net)|-5.43||||0.267|TWO_SIDED|95.0|-15.05|4.19|||Mixed Models Analysis|||||4.19|-15.05|.267
72404209|NCT03711162|144315020|SUPERIORITY||LS mean difference|2.9|||||TWO_SIDED|95.0|-11.1|16.8|||||The treatment effect was determined by using estimated least square mean difference between each active treatment group and placebo from the mixed model.|||16.8|-11.1|
72489045|NCT03577730|144506308|OTHER|||||||0.802|||||||Mixed Models Analysis|||Analysis for visual analog scale scores at rest presented.||||0.802
72489046|NCT03577730|144506309|OTHER|||||||0.32|||||||Mixed Models Analysis|||||||0.320
72489047|NCT03577730|144506310|OTHER|||||||0.67|||||||Wilcoxon (Mann-Whitney)|||||||0.670
72489048|NCT03577730|144506311|OTHER|||||||0.595|||||||Fisher Exact|||||||0.595
72489049|NCT03577730|144506312|OTHER|||||||0.985|||||||Fisher Exact|||||||0.985
72489050|NCT03577730|144506313|OTHER|||||||0.417|||||||Wilcoxon (Mann-Whitney)|||||||0.417
72489051|NCT03577730|144506314|OTHER|||||||0.432|||||||Wilcoxon (Mann-Whitney)|||||||0.432
72489052|NCT03577730|144506315|OTHER|||||||0.673|||||||Wilcoxon (Mann-Whitney)|||||||0.673
72489053|NCT03577730|144506316|OTHER|||||||0.058|||||||Chi-squared|||||||0.058
72489054|NCT01911442|144506326|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.3|STANDARD_ERROR_OF_MEAN|2.15||0.5463|TWO_SIDED|95.0|-5.6|3.0|||Mixed Models Analysis|||LS Mean, LS mean difference and the associated 95% Cl and p-value for change from baseline are based on Mixed Model for Repeated Measures (MMRM).||3.0|-5.6|0.5463
72489055|NCT01911442|144506326|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.9|STANDARD_ERROR_OF_MEAN|2.09||0.3592|TWO_SIDED|95.0|-6.1|2.2|||Mixed Models Analysis|||LS Mean, LS mean difference, and the associated 95% CI and p-value for change from baseline are based on Mixed Model for Repeated Measures.||2.2|-6.1|0.3592
72516031|NCT00074802|144562977|SUPERIORITY|||||||0.018||||||Fisher's Exact Test used for analyses.|Fisher Exact|||Fisher's Exact Test used for analyses of responder status.||||.018
72516032|NCT00074802|144562977|SUPERIORITY|||||||0.034||||||Fisher's Exact Test used for analyses.|Fisher Exact|||Fisher's Exact Test used for analyses of remitter status.||||.034
72516033|NCT00074802|144562978|SUPERIORITY||Mean Difference (Net)|-3.21||||0.0005|TWO_SIDED|95.0|-5.02|-1.39|||Mixed Models Analysis|||||-1.39|-5.02|.0005
72404210|NCT03711162|144315021|SUPERIORITY||Hazard Ratio (HR)|1.08|||||TWO_SIDED|95.0|0.65|1.78|||||Hazard ratio and 95% confidence interval originated from a Cox proportional hazards model for time to first all cause hospitalization.|||1.78|0.65|
72516034|NCT00074802|144562979|SUPERIORITY||Mean Difference (Net)|-5.61||||0.0775|TWO_SIDED|95.0|-11.84|0.62|||Mixed Models Analysis|||||0.62|-11.84|.0775
72516035|NCT00074802|144562980|SUPERIORITY||Mean Difference (Net)|-5.53||||0.0006|TWO_SIDED|95.0|-8.7|-2.35|||Mixed Models Analysis||Paroxetine+CBT \> Paroxetine alone in BFNE change.|||-2.35|-8.70|.0006
72489056|NCT01911442|144506327|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.25||0.1755|TWO_SIDED||||||Mixed Models Analysis||This is due to rounding. the LSM for Lurasidone 20 mg/d at week 6 was -1.069 vs -0.734 for placebo group. So the LSM of the treatment difference between Lurasidone 20 mg/d and placebo was 0.335 if 3 decimals are reported.|||||0.1755
72516036|NCT00074802|144562981|SUPERIORITY||Mean Difference (Net)|0.2||||0.871|TWO_SIDED|95.0|-2.16|2.55|||Mixed Models Analysis|||||2.55|-2.16|.871
72516037|NCT00074802|144562982|SUPERIORITY||Median Difference (Net)|0.41||||0.949|TWO_SIDED|95.0|-11.95|12.76|||Mixed Models Analysis|||||12.76|-11.95|.949
72516038|NCT01784588|144563004|NON_INFERIORITY|Non-inferiority (NI) was demonstrated if the entire confidence interval was above -15% at 36 months. The sample size was estimated under the assumption that the proportion of subjects with treatment success is 85% for each of Solyx and Obtryx. For a (one-sided) type I error rate of 0.05, 194 subjects (97 per arm) are needed to have 90% power to demonstrate non-inferiority of Solyx with a NI margin of 15%.|Adjusted Difference in Percentages|-0.4|||||TWO_SIDED|90.0|-8.2|7.4||Non-inferiority was evaluated using a two-sided 90% confidence interval (CI) for the treatment difference (SIS minus TMUS). The CI was calculated based on the pooling of treatment differences across propensity score strata for a binary endpoint.||||Available Cases Only - Intent-to-Treat||7.4|-8.2|
72489057|NCT01911442|144506327|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.24||0.2402|TWO_SIDED||||||Mixed Models Analysis|||||||0.2402
72489058|NCT00122681|144506335|SUPERIORITY_OR_OTHER||1-Rate Ratio|92.9|||||TWO_SIDED|95.0|79.9|98.3||||||Vaccine efficacy against CIN2+ associated with HPV-16 or HPV-18 (by PCR) in HPV DNA negative and seronegative subjects at baseline, using conditional exact method. The VE was defined as follows: VE = 1-Rate Ratio (RR), where RR = incidence rate in HPV Group (vaccine)/ incidence rate in HAV Group (control); Incidence rate = n/T(per 100); n= number of subjects reporting at least one event in each group and T(years) = sum of follow-up period (censored at the first occurrence of an event) expressed.||98.3|79.9|
72489059|NCT00122681|144506335|SUPERIORITY_OR_OTHER||1-Rate Ratio|95.7|||||TWO_SIDED|95.0|82.9|99.6||||||Vaccine efficacy against CIN2+ associated with HPV-16 (by PCR) in HPV DNA negative and seronegative subjects at baseline, using conditional exact method. The VE was defined as follows: VE = 1-Rate Ratio (RR), where RR = incidence rate in HPV Group (vaccine)/ incidence rate in HAV Group (control); Incidence rate = n/T(per 100); n= number of subjects reporting at least one event in each group and T(years) = sum of follow-up period (censored at the first occurrence of an event) expressed.||99.6|82.9|
72489060|NCT00122681|144506335|SUPERIORITY_OR_OTHER||1-Rate Ratio|86.7|||||TWO_SIDED|95.0|39.7|98.7||||||Vaccine efficacy against CIN2+ associated with HPV-18 (by PCR) in HPV DNA negative and seronegative subjects at baseline, using conditional exact method. The VE was defined as follows: VE = 1-Rate Ratio (RR), where RR = incidence rate in HPV Group (vaccine)/ incidence rate in HAV Group (control); Incidence rate = n/T(per 100); n= number of subjects reporting at least one event in each group and T(years) = sum of follow-up period (censored at the first occurrence of an event) expressed.||98.7|39.7|
72516039|NCT01784588|144563004|NON_INFERIORITY|Non-inferiority (NI) was demonstrated if the entire confidence interval was above -15% at 36 months. The sample size was estimated under the assumption that the proportion of subjects with treatment success is 85% for each of Solyx and Obtryx. For a (one-sided) type I error rate of 0.05, 194 subjects (97 per arm) are needed to have 90% power to demonstrate non-inferiority of Solyx with a NI margin of 15%.|Unadjusted Treatment Difference (%)|1.5|||||TWO_SIDED|90.0|-5.4|8.4||Non-inferiority was evaluated using a two-sided 90% confidence interval (CI) for the treatment difference (SIS minus TMUS). The CI was calculated based on the pooling of treatment differences across propensity score strata for a binary endpoint.||||Available Cases Only - Intent-to-Treat||8.4|-5.4|
72516040|NCT02466412|144563005|SUPERIORITY_OR_OTHER_LEGACY||Geometric LS Mean Ratio|63.9326|||||TWO_SIDED|95.0|49.6045|82.3991|||ANOVA|The model included terms for sequence, subject nested within sequence, period, and product as fixed effect factors.|"Geometric LS mean ratio (CHTP 1.1 M:mCC).~Expressed as %"|The objective of this study was to determine the point estimate and precision of the CHTP 1.1 M:mCC ratio for Cmax. Therefore, there was no statistical hypothesis to be tested for this objective.||82.3991|49.6045|
72624341|NCT00863304|144778630|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.34|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-0.49|-0.18||P-value was based on pairwise comparisons.|ANCOVA|||Week 2: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.18|-0.49|<0.001
72404211|NCT03711162|144315021|SUPERIORITY||Hazard Ratio (HR)|1.23|||||TWO_SIDED|95.0|0.76|1.98|||||Hazard ratio and 95% confidence interval originated from a Cox proportional hazards model for time to first all cause hospitalization.|||1.98|0.76|
72516041|NCT02466412|144563006|SUPERIORITY_OR_OTHER_LEGACY||Geometric LS Mean Ratio|60.0052|||||TWO_SIDED|95.0|44.9517|80.0997|||ANOVA|The model included terms for sequence, subject nested within sequence, period, and product as fixed effect factors.|"Geometric LS mean ratio (CHTP 1.1 M:mCC).~Expressed as %"|The objective of this study was to determine the point estimate and precision of the CHTP 1.1 M:mCC ratio for AUC(0-last). Therefore, there was no statistical hypothesis to be tested for this objective.||80.0997|44.9517|
72516042|NCT02553317|144563007|SUPERIORITY||||||=|0.0099||||||The resulting p-value was compared with a significance level of 5%.|Log Rank|||Time to platelet count response in the caplacizumab arm and placebo arm was compared by conducting a two-sided stratified log-rank test based on a KM analysis, with severity of neurological involvement (according to the Glasgow coma scale \[GCS\] category, stratification factor used in randomization: ≤12 / 13-15) as stratification factor.||||= 0.0099
72516043|NCT02553317|144563007|SUPERIORITY||Hazard Ratio (HR)|1.55|||||TWO_SIDED|95.0|1.095|2.195|||||The HR was estimated from a Cox proportional Hazards regression model.|Time to platelet count response was analyzed using a Cox proportional hazards regression model with time to platelet count response as dependent variable, and treatment group and GCS category as independent variables. The hazard (or platelet count normalization rate) ratio from the Cox model was reported along with 95% CI.||2.195|1.095|
72404212|NCT03711162|144315024|SUPERIORITY||Hazard Ratio (HR)|1.29|||||TWO_SIDED|95.0|0.44|3.81|||||Hazard ratio and 95% confidence interval originated from a Cox proportional hazards model for time to first acute IPF exacerbation.|||3.81|0.44|
72404213|NCT03711162|144315024|SUPERIORITY||Hazard Ratio (HR)|1.21|||||TWO_SIDED|95.0|0.42|3.5|||||Hazard ratio and 95% confidence interval originated from a Cox proportional hazards model for time to first acute IPF exacerbation.|||3.50|0.42|
72404214|NCT03711162|144315025|SUPERIORITY||Hazard Ratio (HR)|1.64|||||TWO_SIDED|95.0|0.66|4.08|||||Hazard ratio and 95% confidence interval originated from a Cox proportional hazards model for time to first all cause mortality or hospitalization for non-elective lung transplant.|||4.08|0.66|
72404215|NCT03711162|144315025|SUPERIORITY||Hazard Ratio (HR)|0.98|||||TWO_SIDED|95.0|0.36|2.61|||||Hazard ratio and 95% confidence interval originated from a Cox proportional hazards model for time to first all cause mortality or hospitalization for non-elective lung transplant.|||2.61|0.36|
72404216|NCT03711162|144315026|SUPERIORITY||Hazard Ratio (HR)|1.64|||||TWO_SIDED|95.0|0.66|4.08|||||Hazard ratio and 95% confidence interval originated from a Cox proportional hazards model for time to first all cause mortality, hospitalization for non-elective lung transplant or hospitalization for qualifying for lung transplant.|||4.08|0.66|
72404217|NCT03711162|144315026|SUPERIORITY||Hazard Ratio (HR)|0.98|||||TWO_SIDED|95.0|0.36|2.61|||||Hazard ratio and 95% confidence interval originated from a Cox proportional hazards model for time to first all cause mortality, hospitalization for non-elective lung transplant or hospitalization for qualifying for lung transplant.|||2.61|0.36|
72404218|NCT03711162|144315027|SUPERIORITY||Hazard Ratio (HR)|1.06|||||TWO_SIDED|95.0|0.59|1.91|||||Hazard ratio and 95% confidence interval originated from a Cox proportional hazards model for time to first all-cause mortality or hospitalization that meets \>=10% absolute decline in %FVC or respiratory-related hospitalization.|||1.91|0.59|
72404219|NCT03711162|144315027|SUPERIORITY||Hazard Ratio (HR)|0.79|||||TWO_SIDED|95.0|0.43|1.46|||||Hazard ratio and 95% confidence interval originated from a Cox proportional hazards model for time to first all-cause mortality or hospitalization that meets \>=10% absolute decline in %FVC or respiratory-related hospitalization.|||1.46|0.43|
72516044|NCT02553317|144563008|SUPERIORITY||||||<|0.0001||||||The resulting p-value was compared with a significance level of 5%.|Cochran-Mantel-Haenszel|||A Cochran-Mantel-Haenszel (CMH) test was conducted with adjustment for GCS category (stratification factor used in randomization).||||< 0.0001
72516045|NCT02553317|144563009|SUPERIORITY||||||=|0.0004||||||The resulting p-value was compared with a significance level of 5%.|Cochran-Mantel-Haenszel|||A CMH test was conducted with adjustment for GCS category (stratification factor used in randomization).||||= 0.0004
72516046|NCT02553317|144563010|SUPERIORITY||||||=|0.0572||||||The resulting p-value was compared with a significance level of 5%.|Cochran-Mantel-Haenszel|||A CMH test was conducted with adjustment for GCS category (stratification factor used in randomization).||||= 0.0572
72568562|NCT04168190|144668500|SUPERIORITY|Superiority can be concluded if the lower bound of the 95% CI for the estimated GMT ratio (V116/PPSV23) is \>1.0 (1-sided p-value \<0.025).|GMT Ratio|18.21|||<|0.001|TWO_SIDED|95.0|12.98|25.57|||P-value is estimated from a cLDA model.||Phase 2: V116/Phase 2: Pneumovax™23|Serotype 16F. Geometric mean titer (GMT) ratio and 95% confidence interval (CI), and p-value are estimated from a constrained longitudinal data analysis (cLDA) model.||25.57|12.98|<0.001
72404220|NCT03711162|144315028|SUPERIORITY||Hazard Ratio (HR)|1.06|||||TWO_SIDED|95.0|0.59|1.91|||||Hazard ratio and 95% confidence interval originated from a Cox proportional hazards model for time to all-cause mortality or respiratory-related hospitalizations.|||1.91|0.59|
72624342|NCT00863304|144778630|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.14|STANDARD_ERROR_OF_MEAN|0.08||0.076|TWO_SIDED|95.0|-0.01|0.29||P-value was based on pairwise comparisons.|ANCOVA|||Week 2: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||0.29|-0.01|0.076
72404221|NCT03711162|144315028|SUPERIORITY||Hazard Ratio (HR)|0.79|||||TWO_SIDED|95.0|0.43|1.46|||||Hazard ratio and 95% confidence interval originated from a Cox proportional hazards model for time to all-cause mortality or respiratory-related hospitalizations.|||1.46|0.43|
72404222|NCT03034954|144315049|OTHER|||||||0.3||||||Reported p-value represents Time (baseline to post-tDCS) x Condition (Active or Sham) interaction for all OLTT Accuracy Measures. If the multivariate statistic is not significant no univariate statistical analyses are completed.|Repeated Measures ANOVA|repeated measures (OLTT baseline and post-tDCS); between-subjects (active vs. sham)||We used a multivariate statistic to compare OLTT means (Free Recall Total Error, Free Recall Average Error, Cued Recall Total Error, Cued Recall Average Error, Recognition Total Correct) at baseline (Version B) to post HD-tDCS OLTT means (Version C), by groups (active vs. sham). The overall statistic represents the simultaneous comparison of baseline OLTT measures to post HD-tDCS OLTT measures.||||.300
72404223|NCT03034954|144315051|OTHER|||||||0.044||||||Statistic represents the interaction between Time (baseline to post-tDCS) by Condition (Active vs. Sham).|Repeated Measures ANOVA|||A Repeated Measures ANOVA was used to compare baseline OLTT (Version B) to post-tDCS OLTT (Version C) across the treatment groups (Active vs. Sham). The multivariate analyses included OLTT Response Times (i.e., Free Recall Average Response Time, Cued Recall Average Response Time, Recognition Average Response Time)||||.044
72404224|NCT03034954|144315051|OTHER|||||||0.006|||||||Repeated Measures ANOVA|||Univariate analysis of the OLTT Free Recall Average Time to Respond following significant multivariate repeated measures ANOVA comparing baseline OLTT (Version B) to post-tDCS OLTT (Version C) across the treatment groups (Active vs. Sham).||||.006
72404225|NCT03034954|144315054|OTHER|||||||0.15|||||||Repeated Measures ANOVA|||Univariate analysis of the OLTT Cued Recall Average Time to Respond following significant multivariate repeated measures ANOVA comparing baseline OLTT (Version B) to post-tDCS OLTT (Version C) across the treatment groups (Active vs. Sham).||||.15
72516047|NCT02219087|144563021|SUPERIORITY_OR_OTHER|||||||0.137|||||||t-test, 2 sided|||||||0.137
72516048|NCT02219087|144563022|SUPERIORITY_OR_OTHER|||||||0.343|||||||t-test, 2 sided|||||||0.343
72516049|NCT02219087|144563023|SUPERIORITY_OR_OTHER|||||||0.208|||||||t-test, 2 sided|||||||0.208
72516050|NCT02219087|144563024|SUPERIORITY_OR_OTHER|||||||0.385|||||||t-test, 2 sided|||||||0.385
72516051|NCT02219087|144563025|SUPERIORITY_OR_OTHER|||||||0.843|||||||Chi-squared|||||||0.843
72516052|NCT02219087|144563026|SUPERIORITY_OR_OTHER|||||||0.438|||||||Wilcoxon (Mann-Whitney)|||||||0.438
72516053|NCT00094887|144563069|OTHER||||||=|0.8085|||||||Wilcoxon (Mann-Whitney)|||||||= 0.8085
72516054|NCT04111107|144563103|OTHER|||||||0.966|||||||Wilcoxon signed rank (2 sided)|||H0: Progression-free ratio = 1||||0.966
72516055|NCT04111107|144563106|OTHER|Single proportion was estimated.|proportion|4.2|||||TWO_SIDED|95.0|0.1|21.1|||||exact binomial confidence interval|The proportion with a complete or partial response was estimated and an exact binomial confidence interval was calculated||21.1|0.1|
72516056|NCT03956225|144563114|NON_INFERIORITY|Noninferiority in change from baseline in MGS was declared if the lower confidence limit (LCL) was greater than -5.|Least Squares Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|1.07|||ONE_SIDED|95.0|-2.2||||Mixed effects repeated measures||Standard Error of the Least Squares Mean is presented. Least squares mean difference (iLux minus LipiFlow). Lower Confidence Limit is presented.||||-2.2|
72516057|NCT04093258|144563115|NON_INFERIORITY|Non-inferiority will be concluded if the lower limit is above 0.67. Superiority will be concluded if the lower limit is above 1.0.|Odds Ratio (OR)|1.51|||||TWO_SIDED|95.0|0.33|6.85|||Generalized Linear Mixed Model Analysis|Finite-sample corrected Akaike's Information Criterion|Odds ratio was calculated as Test/Control|"The proportion of response (1) was analyzed using a generalized linear mixed model with a binary distribution and logit link function for all questions."||6.85|0.33|
72516058|NCT04093258|144563116|NON_INFERIORITY|Non-inferiority will be concluded if the lower limit is above 0.67. Superiority will be concluded if the lower limit is above 1.0.|Odds Ratio (OR)|0.34|||||TWO_SIDED|95.0|0.1|1.19|||Generalized Linear Mixed Model Analysis|Finite-sample corrected Akaike's Information Criterion|Odds ratio was calculated as Test over Control|"The proportion of response (1) was analyzed using a generalized linear mixed model with a binary distribution and logit link function for all questions."||1.19|0.10|
72516059|NCT04093258|144563117|NON_INFERIORITY|The non-inferiority of the Test lens relative to the Control will be concluded if the lower confidence limit of LSM difference is above the non-inferiority margin -5.|Least square mean difference|-5.98|STANDARD_ERROR_OF_MEAN|3.202|||TWO_SIDED|95.0|-12.48|0.52|||Mixed Model Analysis|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.|Mean difference was calculated as Test minus Control|||0.52|-12.48|
72516060|NCT00594204|144563118|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.78|||<|0.0001||95.0|2.97|7.68||p-values are obtained from a logistic regression model including the main effects of treatment and country|Regression, Logistic||Odds Ratios obtained from a logistic regression model including the main effects of treatment and country|||7.68|2.97|<0.0001
72516061|NCT00594204|144563119|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.0|||<|0.0001||95.0|3.3|7.5||p-values obtained from a logistic regression model including the main effects of treatment and country|Regression, Logistic||Odds ratios obtained from a logistic regression model including the main effects of treatment and country|Week 12||7.5|3.3|<0.0001
72516062|NCT00594204|144563119|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.3|||<|0.0001||95.0|2.8|6.5||p-values obtained from a logistic regression model including the main effects of treatment and country|Regression, Logistic||Odds ratios obtained from a logistic regression model including the main effects of treatment and country|Week 24||6.5|2.8|<0.0001
72516063|NCT00594204|144563120|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.76|||<|0.0001||95.0|3.74|8.88|||Regression, Logistic|p-value are obtained from a logistic regression model including the main effects of treatment and country|Odds Ratios obtained from a logistic regression model including the main effects of treatment and country|||8.88|3.74|<0.0001
72516064|NCT01401465|144563121|SUPERIORITY_OR_OTHER||Slope|88.235|||<|0.0001||||||The significance level was set at 0.025 to adjust for the fact that two co-primary endpoints were being tested.|Two-sided Signed Rank Test||Hodges-Lehman estimate of the CI not available due to ties.|The null hypothesis is that the median of the standardized Total Preference Score = 50. Values \> 50 indicate preference for ciclesonide, while values \< 50 indicate preference for mometasone. For the primary endpoint of the Total Preference Score, assuming an SD of 40, a sample size of 155 will have 80% power to detect a difference of 0.25 SD units (10 raw score units) from the neutrality preference population value of 50, using a single group t-test with a 0.025 two-sided significance level.||||<0.0001
72516065|NCT01401465|144563122|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|13.9|||<|0.0001|TWO_SIDED|95.0|11.22|16.58||The significance level was set at 0.025 to adjust for the fact that two co-primary endpoints were being tested.|Linear Mixed Model|Linear Mixed Model with effects for Period, Treatment, Sex, Race, Study Center, and covariates of Age and Baseline.||The null hypothesis is that the mean change from baseline (CfBL) for CIC is equal to the mean CfBL for MOM. In Study 060-301, a correlation between BL periods 1 and 2 of 0.7 and a change score SD of 15 was seen for the RACS. A sample size of 41 in each sequence group (82 total ) gives a 2 x 2 crossover design 80% power to detect the difference in the CfBL of 0.35 SD units (5.25 raw score units) using a two group t-test with a 0.025 two-sided significance level and a SD of 15 for the difference.||16.58|11.22|<0.0001
72516066|NCT01401465|144563122|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.88|||<|0.0001|TWO_SIDED|95.0|2.2|7.56||The significance level was set at 0.025 to adjust for the fact that two co-primary endpoints were being tested.|Linear Mixed Model|Linear Mixed Model with effects for Period, Treatment, Sex, Race, Study Center, and covariates of Age and Baseline||The null hypothesis is that the mean change from baseline (CfBL) for CIC is equal to the mean CfBL for MOM. In Study 060-301, a correlation between BL periods 1 and 2 of 0.7 and a change score SD of 15 was seen for the RACS. A sample size of 41 in each sequence group (82 total ) gives a 2 x 2 crossover design 80% power to detect the difference in the CfBL of 0.35 SD units (5.25 raw score units) using a two group t-test with a 0.025 two-sided significance level and a SD of 15 for the difference.||7.56|2.20|<0.0001
72568563|NCT04168190|144668500|SUPERIORITY|Superiority can be concluded if the lower bound of the 95% CI for the estimated GMT ratio (V116/PPSV23) is \>1.0 (1-sided p-value \<0.025).|GMT Ratio|19.45|||<|0.001|TWO_SIDED|95.0|12.87|29.4|||P-value is estimated from a cLDA model.||Phase 2: V116/Phase 2: Pneumovax™23|Serotype 23A. Geometric mean titer (GMT) ratio and 95% confidence interval (CI), and p-value are estimated from a constrained longitudinal data analysis (cLDA) model.||29.40|12.87|<0.001
72624343|NCT00863304|144778630|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.21|STANDARD_ERROR_OF_MEAN|0.08||0.007|TWO_SIDED|95.0|0.06|0.37||P-value was based on pairwise comparisons.|ANCOVA|||Week 2: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||0.37|0.06|0.007
72624344|NCT00863304|144778630|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-0.56|-0.24||P-value was based on pairwise comparisons.|ANCOVA|||Week 4: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.24|-0.56|<0.001
72404226|NCT03034954|144315056|OTHER|||||||0.3|||||||Repeated Measures ANOVA|||Univariate analysis of the OLTT Recognition Average Time to Respond following significant multivariate repeated measures ANOVA comparing baseline OLTT (Version B) to post-tDCS OLTT (Version C) across the treatment groups (Active vs. Sham).||||.3
72404227|NCT03034954|144315061|OTHER|||||||0.45|||||||MANOVA|||A Multivariate ANOVA was used to compare Active vs. Sham groups on discriminability measures (i.e. 0-back d', 2-back d', semantic 2-back d') and calculated working memory measures (i.e., 2-back d' minus 0-back d', semantic 2-back d' minus 0-back d').||||.450
72404228|NCT03034954|144315062|OTHER|||||||0.078|||||||Chi-squared|||Chi-squared tests were conducted to determine group differences in actual condition assignment vs. estimated/perceived condition||||.078
72404229|NCT03034954|144315063|OTHER|||||||0.233|||||||Fisher Exact|||||||.233
72404230|NCT03034954|144315065|OTHER|||||||0.6|||||||Fisher Exact|||||||.600
72404231|NCT03034954|144315066|OTHER|||||||0.999|||||||Fisher Exact|||||||.999
72404232|NCT03034954|144315067|OTHER|||||||0.281|||||||Fisher Exact|||||||.281
72404233|NCT03034954|144315068|OTHER|||||||0.082|||||||Fisher Exact|||||||.082
72404234|NCT03034954|144315069|OTHER|||||||0.49|||||||Fisher Exact|||||||.490
72516067|NCT01401465|144563123|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|88.889|||<|0.0001||||||If both primary endpoints are significant, the evaluation of this key secondary endpoint will be conducted at a significance level of 0.05.|Two-sided signed-rank test||Hodges-Lehman estimate of the CI not available due to ties.|The null hypothesis is that the median of the standardized Treatment Process Composite Preference Score = 50. Values \> 50 indicate preference for ciclesonide, while values \< 50 indicate preference for mometasone. Assuming an SD of 40, as observed in Study 060-301, a sample size of 128 will have 80% power to detect a difference of 0.25 SD units (10 raw score units) from the neutrality preference population value of 50, using a single group t-test with a 0.05 two-sided significant level||||<0.0001
72404235|NCT03034954|144315070|OTHER|||||||0.488|||||||Fisher Exact|||||||.488
72404236|NCT03034954|144315071|OTHER|||||||0.219|||||||Fisher Exact|||||||.219
72404237|NCT00394212|144315092|SUPERIORITY_OR_OTHER|||||||0.066||95.0||||P-value from non-parametric Mann-Whitney-Wilcoxon test comparing treatments.|Wilcoxon (Mann-Whitney)|||Based on a 2-group test of means for unequal variance and unequal sample size (2:1 randomization ratio) with alpha = 0.05 and a power of 80%, the sample size required was 132; 88 subjects in the Transoral Suturing arm and 44 in the Sham Endoscopy arm. The study was prematurely discontinued due to reasons unrelated to safety and effectiveness and therefore was underpowered for evaluation of the primary and secondary hypotheses.||||0.066
72404238|NCT00394212|144315093|SUPERIORITY_OR_OTHER|||||||0.317||95.0||||P-value from two-sided Fisher's exact test comparing percents achieving 15% EWL at 6 months for the two treatments.|Fisher Exact|||||||0.317
72404239|NCT00394212|144315094|SUPERIORITY_OR_OTHER|||||||0.019||95.0||||P-value from two-sided Fisher's exact test comparing percents achieved for the two treatments.|Fisher Exact|||||||0.019
72404240|NCT00394212|144315095|SUPERIORITY_OR_OTHER|||||||0.174||95.0||||P-value from two-sided Fisher's exact test comparing percents achieved for the two treatments.|Fisher Exact|||||||0.174
72404241|NCT03240133|144315098|SUPERIORITY|Comparisons were performed separately at each time point using a mixed effect linear model including treatment, period and sequence as fixed effects, subject within sequence as a random effect, and predose 3-symptom composite VAS score as a covariate.|Difference in Least Square Means|-6.98||||0.0024|TWO_SIDED|95.0|-11.37|-2.6|||Mixed effect linear model|||Change in HAE attack symptoms from pre-dose to 4 hours post-dose was assessed following treatment with either 750mg berotralstat or placebo.||-2.6|-11.37|0.0024
72404242|NCT03240133|144315098|SUPERIORITY|Comparisons were performed separately at each time point using a mixed effect linear model including treatment, period and sequence as fixed effects, subject within sequence as a random effect, and predose 3-symptom composite VAS score as a covariate.|Difference in Least Square Means|-2.1||||0.6424|TWO_SIDED|95.0|-11.49|7.29|||Mixed effect linear model|||Change in HAE attack symptoms from pre-dose to 4 hours post-dose was assessed following treatment with either 500mg berotralstat or placebo.||7.29|-11.49|0.6424
72404243|NCT03240133|144315098|SUPERIORITY|Comparisons were performed separately at each time point using a mixed effect linear model including treatment, period and sequence as fixed effects, subject within sequence as a random effect, and predose 3-symptom composite VAS score as a covariate.|Difference in Least Square Means|0.57||||0.8283|TWO_SIDED|95.0|-4.9|6.03|||Mixed effect linear model|||Change in HAE attack symptoms from pre-dose to 4 hours post-dose was assessed following treatment with either 250mg berotralstat or placebo.||6.03|-4.9|0.8283
72404244|NCT03240133|144315099|SUPERIORITY||Odds Ratio (OR)|0.196||||0.0029|TWO_SIDED|95.0|0.069|0.559|||logistic mixed effect model|||Analyses were performed using a generalized logistic model including treatment, period and sequence as fixed effects, and subject within sequence as a random effect. The odds of a berotralstat 750 mg-treated-attack requiring SOC-Rx was 0.196 that of a placebo attack.||0.559|0.069|0.0029
72404245|NCT03240133|144315099|SUPERIORITY||Odds Ratio (OR)|0.472||||0.4048|TWO_SIDED|95.0|0.074|2.988|||logistic mixed effect model|||Analyses were performed using a generalized logistic model including treatment, period and sequence as fixed effects, and subject within sequence as a random effect. The odds of a berotralstat 500 mg-treated-attack requiring SOC-Rx was 0.472 that of a placebo attack.||2.988|0.074|0.4048
72404246|NCT03240133|144315099|SUPERIORITY||Odds Ratio (OR)|0.587||||0.5984|TWO_SIDED|95.0|0.073|4.733|||logistic mixed effect model|||Analyses were performed using a generalized logistic model including treatment, period and sequence as fixed effects, and subject within sequence as a random effect. The odds of a berotralstat 250 mg-treated-attack requiring SOC-Rx was 0.587 that of a placebo attack.||4.733|0.073|0.5984
72404247|NCT00116831|144315145|SUPERIORITY_OR_OTHER||Mean diff (RSG-GLP) for atheroma volume|-4.58||||||95.0||||||||||||
72404248|NCT00116831|144315146|SUPERIORITY_OR_OTHER||Mean diff (RSG-GLP) for lumen volume|0.32||||||95.0||||||||||||
72404249|NCT00116831|144315147|SUPERIORITY_OR_OTHER||Mean diff (RSG-GLP) for vessel volume|-3.56||||||95.0||||||||||||
72404250|NCT00116831|144315149|SUPERIORITY_OR_OTHER||Mean diff (RSG-GLP) for atheroma area|-0.13||||||95.0||||||||||||
72404251|NCT00116831|144315150|SUPERIORITY_OR_OTHER||Mean diff (RSG-GLP) for lumen area|0.02||||||95.0||||||||||||
72489061|NCT00122681|144506335|SUPERIORITY_OR_OTHER||1-Rate Ratio|90.8|||||TWO_SIDED|95.0|78.1|96.9||||||Vaccine efficacy against CIN2+ for HPV-16 or HPV-18 (by PCR) in HPV DNA negative subjects at baseline, regardless of initial serostatus, using conditional exact method. The VE was defined as follows: VE = 1-Rate Ratio (RR), where RR = incidence rate in HPV Group (vaccine)/ incidence rate in HAV Group (control); Incidence rate = n/T(per 100); n= number of subjects reporting at least one event in each group and T(years) = sum of follow-up period (censored at the first occurrence of an event).||96.9|78.1|
72489062|NCT00122681|144506335|SUPERIORITY_OR_OTHER||1-Rate Ratio|92.7|||||TWO_SIDED|95.0|79.3|98.2||||||Vaccine efficacy against CIN2+ for HPV-16 (by PCR) in HPV DNA negative subjects at baseline, regardless of initial serostatus, using conditional exact method. The VE was defined as follows: VE = 1-Rate Ratio (RR), where RR = incidence rate in HPV Group (vaccine)/ incidence rate in HAV Group (control); Incidence rate = n/T(per 100); n= number of subjects reporting at least one event in each group and T(years) = sum of follow-up period (censored at the first occurrence of an event).||98.2|79.3|
72489063|NCT00122681|144506335|SUPERIORITY_OR_OTHER||1-Rate Ratio|87.6|||||TWO_SIDED|95.0|44.1|98.8||||||Vaccine efficacy against CIN2+ for HPV-18 (by PCR) in HPV DNA negative subjects at baseline, regardless of initial serostatus, using conditional exact method. The VE was defined as follows: VE = 1-Rate Ratio (RR), where RR = incidence rate in HPV Group (vaccine)/ incidence rate in HAV Group (control); Incidence rate = n/T(per 100); n= number of subjects reporting at least one event in each group and T(years) = sum of follow-up period (censored at the first occurrence of an event).||98.8|44.1|
72516068|NCT01401465|144563124|NON_INFERIORITY_OR_EQUIVALENCE|The 95% CI of the LS mean difference of ciclesonide nasal aerosol minus mometasone aqueous nasal spray was calculated from the ANCOVA model, and the upper bound of the CI was compared to the non-inferiority margin of 0.5. Non-inferiority was declared if the upper bound of the 95% CI of this difference was \< 0.5.|Difference in LS Means|-0.1|||||TWO_SIDED|95.0|-0.3|0.1||f both primary endpoints are significant, the evaluation of this key secondary endpoint will be conducted at a significance level of 0.05.|ANCOVA|Site, treatment, period, treatment sequence as fixed effects, subject nested within sequence as a random effect, and baseline rTNSS as a covariate.|Ciclesonide 74 mcg minus Mometasone 200 mcg|The null hypothesis is that the change from baseline in rTNSS for ciclesonide 74 mcg nasal aerosol minus the change from baseline in rTNSS for mometasone AQ 200 mcg is greater than 0.5.||0.1|-0.3|
72516069|NCT01115738|144563156|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|22.24||||0.188|TWO_SIDED|95.0|-10.98|55.47||P-values were not adjusted for multiplicity. P-values \<0.05 were considered statistically significant.|Mixed Model Repeated Measures Analysis|Fixed effects were Treatment, Visit, Country, Treatment-by-Visit. Participants and Error were Random Effects. Covariance structure was Unstructured.||||55.47|-10.98|0.188
72516070|NCT01115738|144563156|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.93||||0.809|TWO_SIDED|95.0|-28.2|36.07||P-values were not adjusted for multiplicity. P-values \<0.05 were considered statistically significant.|Mixed Model Repeated Measures Analysis|Fixed effects were Treatment, Visit, Country, Treatment-by-Visit. Participants and Error were Random Effects. Covariance structure was Unstructured.||||36.07|-28.20|0.809
72404252|NCT00116831|144315151|SUPERIORITY_OR_OTHER||Mean diff (RSG-GLP) for vessel area|-0.11||||||95.0||||||||||||
72516071|NCT01115738|144563157|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.93||||0.37|TWO_SIDED|95.0|-20.26|54.12||P-value is for Baseline. P-values were not adjusted for multiplicity. P-values \<0.05 were considered statistically significant.|Mixed Model Repeated Measures Analysis|Fixed effects were Treatment, Visit, Country, Treatment-by-Visit. Participants and Error were Random Effects. Covariance structure was Unstructured.||||54.12|-20.26|0.370
72568564|NCT04168190|144668500|SUPERIORITY|Superiority can be concluded if the lower bound of the 95% CI for the estimated GMT ratio (V116/PPSV23) is \>1.0 (1-sided p-value \<0.025).|GMT Ratio|29.88|||<|0.001|TWO_SIDED|95.0|20.72|43.09|||P-value is estimated from a cLDA model.||Phase 2: V116/Phase 2: Pneumovax™23|Serotype 23B. Geometric mean titer (GMT) ratio and 95% confidence interval (CI), and p-value are estimated from a constrained longitudinal data analysis (cLDA) model.||43.09|20.72|<0.001
72568565|NCT04168190|144668500|SUPERIORITY|Superiority can be concluded if the lower bound of the 95% CI for the estimated GMT ratio (V116/PPSV23) is \>1.0 (1-sided p-value \<0.025).|GMT Ratio|32.02|||<|0.001|TWO_SIDED|95.0|22.83|44.89|||P-value is estimated from a cLDA model.||Phase 2: V116/Phase 2: Pneumovax™23|Serotype 24F. Geometric mean titer (GMT) ratio and 95% confidence interval (CI), and p-value are estimated from a constrained longitudinal data analysis (cLDA) model.||44.89|22.83|<0.001
72568566|NCT04168190|144668500|SUPERIORITY|Superiority can be concluded if the lower bound of the 95% CI for the estimated GMT ratio (V116/PPSV23) is \>1.0 (1-sided p-value \<0.025).|GMT Ratio|34.9|||<|0.001|TWO_SIDED|95.0|24.25|50.23|||P-value is estimated from a cLDA model.||Phase 2: V116/Phase 2: Pneumovax™23|Serotype 31. Geometric mean titer (GMT) ratio and 95% confidence interval (CI), and p-value are estimated from a constrained longitudinal data analysis (cLDA) model.||50.23|24.25|<0.001
72404253|NCT00116831|144315154|SUPERIORITY_OR_OTHER||Model adjusted mean diff. (RSG-GLP)|-0.64||||0.1221||95.0|-1.457|0.173|||ANCOVA|||||0.173|-1.457|0.1221
72404254|NCT00116831|144315155|SUPERIORITY_OR_OTHER||Model adjusted mean diff. (RSG-GLP)|-5.12||||||95.0||||||||||||
72404255|NCT00116831|144315157|SUPERIORITY_OR_OTHER||Model adjusted mean diff. (RSG-GLP)|-1.72||||||95.0||||||||||||
72404256|NCT00116831|144315159|SUPERIORITY_OR_OTHER||Model adjusted mean diff. (RSG-GLP)|-0.11||||||95.0||||||||||||
72489064|NCT00122681|144506336|SUPERIORITY_OR_OTHER||1-Rate Ratio|94.9|||||TWO_SIDED|95.0|87.7|98.4||||||Vaccine efficacy against CIN2+ associated with HPV-16 or HPV-18 (by PCR) in HPV DNA negative and seronegative subjects at baseline, using conditional exact method. The VE was defined as follows: VE = 1-Rate Ratio (RR), where RR = incidence rate in HPV Group (vaccine)/ incidence rate in HAV Group (control); Incidence rate = n/T(per 100); n= number of subjects reporting at least one event in each group and T(years) = sum of follow-up period (censored at the first occurrence of an event) expressed||98.4|87.7|
72489065|NCT00122681|144506336|SUPERIORITY_OR_OTHER||1-Rate Ratio|97.6|||||TWO_SIDED|95.0|91.0|99.7||||||Vaccine efficacy against CIN2+ associated with HPV-16 (by PCR) in HPV DNA negative and seronegative subjects at baseline, using conditional exact method. The VE was defined as follows: VE = 1-Rate Ratio (RR), where RR = incidence rate in HPV Group (vaccine)/ incidence rate in HAV Group (control); Incidence rate = n/T(per 100); n= number of subjects reporting at least one event in each group and T(years) = sum of follow-up period (censored at the first occurrence of an event) expressed||99.7|91.0|
72489066|NCT00122681|144506336|SUPERIORITY_OR_OTHER||1-Rate Ratio|87.1|||||TWO_SIDED|95.0|57.2|97.5||||||Vaccine efficacy against CIN2+ associated with HPV-18 (by PCR) in HPV DNA negative and seronegative subjects at baseline, using conditional exact method. The VE was defined as follows: VE = 1-Rate Ratio (RR), where RR = incidence rate in HPV Group (vaccine)/ incidence rate in HAV Group (control); Incidence rate = n/T(per 100); n= number of subjects reporting at least one event in each group and T(years) = sum of follow-up period (censored at the first occurrence of an event) expressed.||97.5|57.2|
72489067|NCT00122681|144506336|SUPERIORITY_OR_OTHER||1-Rate Ratio|93.6|||||TWO_SIDED|95.0|86.3|97.5||||||Vaccine efficacy against CIN2+ for HPV-16 or HPV-18 (by PCR) in HPV DNA negative subjects at baseline, regardless of initial serostatus, using conditional exact method. The VE was defined as follows: VE = 1-Rate Ratio (RR), where RR = incidence rate in HPV Group (vaccine)/ incidence rate in HAV Group (control); Incidence rate = n/T(per 100); n= number of subjects reporting at least one event in each group and T(years) = sum of follow-up period (censored at the first occurrence of an event).||97.5|86.3|
72489068|NCT00122681|144506336|SUPERIORITY_OR_OTHER||1-Rate Ratio|95.7|||||TWO_SIDED|95.0|88.5|98.9||||||Vaccine efficacy against CIN2+ for HPV-16 (by PCR) in HPV DNA negative subjects at baseline, regardless of initial serostatus, using conditional exact method. The VE was defined as follows: VE = 1-Rate Ratio (RR), where RR = incidence rate in HPV Group (vaccine)/ incidence rate in HAV Group (control); Incidence rate = n/T(per 100); n= number of subjects reporting at least one event in each group and T(years) = sum of follow-up period (censored at the first occurrence of an event).||98.9|88.5|
72489069|NCT00122681|144506336|SUPERIORITY_OR_OTHER||1-Rate Ratio|87.6|||||TWO_SIDED|95.0|59.2|97.6||||||Vaccine efficacy against CIN2+ for HPV-18 (by PCR) in HPV DNA negative subjects at baseline, regardless of initial serostatus, using conditional exact method. The VE was defined as follows: VE = 1-Rate Ratio (RR), where RR = incidence rate in HPV Group (vaccine)/ incidence rate in HAV Group (control); Incidence rate = n/T(per 100); n= number of subjects reporting at least one event in each group and T(years) = sum of follow-up period (censored at the first occurrence of an event).||97.6|59.2|
72489070|NCT00122681|144506361|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.798||||0.391|TWO_SIDED|95.0|0.476|1.337|||Chi-squared|||Hazard ratio of anti-HPV-16 GMTs at Month 7 (by ELISA) in subjects without 6-month persistent infection compared to subjects with 6-month persistent infection||1.337|0.476|0.3910
72489071|NCT00122681|144506363|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.778||||0.3796|TWO_SIDED|95.0|0.444|1.362|||Chi-squared|||Hazard ratio of anti-HPV-16 GMTs at Month 7 (by ELISA) in subjects without 12-month persistent infection compared to subjects with 12-month persistent infection.||1.362|0.444|0.3796
72489072|NCT00122681|144506365|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.61||||0.1035||95.0|0.337|1.106|||Chi-squared|||Hazard ratio of anti-HPV-18 GMTs at Month 7 (by ELISA) in subjects without 6-month persistent infection compared to subjects with 6-month persistent infection.||1.106|0.337|0.1035
72516072|NCT01115738|144563157|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|35.89||||0.052|TWO_SIDED|95.0|-0.29|72.06||P-value is for Baseline. P-values were not adjusted for multiplicity. P-values \<0.05 were considered statistically significant.|Mixed Model Repeated Measures Analysis|Fixed effects were Treatment, Visit, Country, Treatment-by-Visit. Participants and Error were Random Effects. Covariance structure was Unstructured.||||72.06|-0.29|0.052
72516073|NCT01115738|144563157|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.45||||0.703|TWO_SIDED|95.0|-39.55|58.45||P-value is for 2 hours after prasugrel LD. P-values were not adjusted for multiplicity. P-values \<0.05 were considered statistically significant.|Mixed Model Repeated Measures Analysis|Fixed effects were Treatment, Visit, Country, Treatment-by-Visit. Participants and Error were Random Effects. Covariance structure was Unstructured.||||58.45|-39.55|0.703
72624345|NCT00863304|144778630|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.42|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-0.58|-0.26||P-value was based on pairwise comparisons.|ANCOVA|||Week 4: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.26|-0.58|<0.001
72624346|NCT00863304|144778630|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.27|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-0.43|-0.11||P-value was based on pairwise comparisons.|ANCOVA|||Week 4: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.11|-0.43|<0.001
72404257|NCT00116831|144315160|SUPERIORITY_OR_OTHER||Treatment difference (RSG-GLP)|-0.1||||||95.0||||||||||||
72404258|NCT00116831|144315161|SUPERIORITY_OR_OTHER||Treatment difference (RSG-GLP)|-0.88||||||95.0||||||||||||
72489073|NCT00122681|144506367|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.635||||0.2111|TWO_SIDED|95.0|0.312|1.293|||Chi-squared|||Hazard ratio of anti-HPV-18 GMTs at Month 7 (by ELISA) in subjects without 12-month persistent infection compared to subjects with 12-month persistent infection.||1.293|0.312|0.2111
72489074|NCT02819635|144506369|SUPERIORITY||Adjusted risk difference (%)|8.4||||0.049|TWO_SIDED|95.0|0.0|16.8||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by previous biologic use, baseline corticosteroid use and baseline Adapted Mayo score (≤ 7 and \> 7)|Difference = Upadacitinib 7.5 mg - Placebo|Substudy 1: Upadacitinib 7.5 mg vs Placebo||16.8|0.0|0.049
72489075|NCT02819635|144506369|SUPERIORITY||Adjusted risk difference (%)|13.5||||0.01|TWO_SIDED|95.0|3.3|23.8||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by previous biologic use, baseline corticosteroid use and baseline Adapted Mayo score (≤ 7 and \> 7)|Difference = Upadacitinib 15 mg - Placebo|Substudy 1: Upadacitinib 15 mg vs Placebo||23.8|3.3|0.010
72489076|NCT02819635|144506369|SUPERIORITY||Adjusted risk difference (%)|13.8||||0.007|TWO_SIDED|95.0|3.8|23.9||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by previous biologic use, baseline corticosteroid use and baseline Adapted Mayo score (≤ 7 and \> 7)|Difference = Upadacitinib 30 mg - Placebo|Substudy 1: Upadacitinib 30 mg vs Placebo||23.9|3.8|0.007
72489077|NCT02819635|144506369|SUPERIORITY||Adjusted risk difference (%)|21.1|||<|0.001|TWO_SIDED|95.0|8.6|33.6||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by previous biologic use, baseline corticosteroid use and baseline Adapted Mayo score (≤ 7 and \> 7)|Difference = Upadacitinib 45 mg - Placebo|Substudy 1: Upadacitinib 45 mg vs Placebo||33.6|8.6|<0.001
72489078|NCT02819635|144506370|SUPERIORITY||Adjusted risk difference (%)|21.6|||<|0.001|TWO_SIDED|95.0|15.8|27.4||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by bio-IR status (bio-IR vs. non-bio-IR), Baseline corticosteroid use (yes vs. no) and Baseline Adapted Mayo score (≤ 7 vs. \> 7)|Difference = Upadacitinib 45 mg - Placebo|Substudy 2: Upadacitinib 45 mg vs Placebo||27.4|15.8|<0.001
72489079|NCT02819635|144506371|SUPERIORITY||Adjusted risk difference (%)|30.7|||<|0.001|TWO_SIDED|95.0|21.7|39.8||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by Bio-IR (Bio-IR/Non-Bio-IR) at Baseline of Induction Study; clinical remission at Week 0 (yes/no); corticosteroid use at Week 0 (yes/no)|Difference = Upadacitinib 15 mg - Placebo|Substudy 3: Upadacitinib 15 mg vs Placebo||39.8|21.7|<0.001
72489080|NCT02819635|144506371|SUPERIORITY||Adjusted risk difference (%)|39.0|||<|0.001|TWO_SIDED|95.0|29.7|48.2||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by Bio-IR (Bio-IR/Non-Bio-IR) at Baseline of Induction Study; clinical remission at Week 0 (yes/no); corticosteroid use at Week 0 (yes/no)|Difference = Upadacitinib 30 mg - Placebo|Substudy 3: Upadacitinib 30 mg vs Placebo||48.2|29.7|<0.001
72489081|NCT02819635|144506372|SUPERIORITY||Adjusted risk difference (%)|13.1||||0.03|TWO_SIDED|95.0|1.2|25.0||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by previous biologic use, baseline corticosteroid use and baseline Adapted Mayo score (≤ 7 and \> 7)|Difference = Upadacitinib 7.5 mg - Placebo|Substudy 1: Upadacitinib 7.5 mg vs Placebo||25.0|1.2|0.030
72516074|NCT01115738|144563157|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.45||||0.823|TWO_SIDED|95.0|-42.53|53.44||P-value is for 2 hours after prasugrel LD. P-values were not adjusted for multiplicity. P-values \<0.05 were considered statistically significant.|Mixed Model Repeated Measures Analysis|Fixed effects were Treatment, Visit, Country, Treatment-by-Visit. Participants and Error were Random Effects. Covariance structure was Unstructured.||||53.44|-42.53|0.823
72404259|NCT00116831|144315162|SUPERIORITY_OR_OTHER||Treatment difference (RSG-GLP)|-47.23||||||95.0||||||||||||
72404260|NCT00116831|144315163|SUPERIORITY_OR_OTHER||Treatment difference (RSG-GLP)|-16.9||||||95.0||||||||||||
72489082|NCT02819635|144506372|SUPERIORITY||Adjusted risk difference (%)|27.6|||<|0.001|TWO_SIDED|95.0|13.1|42.1||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by previous biologic use, baseline corticosteroid use and baseline Adapted Mayo score (≤ 7 and \> 7)|Difference = Upadacitinib 15 mg - Placebo|Substudy 1: Upadacitinib 15 mg vs Placebo||42.1|13.1|<0.001
72516075|NCT01115738|144563157|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|28.69||||0.054|TWO_SIDED|95.0|-0.47|57.84||P-value is for 24 hours after prasugrel LD. P-values were not adjusted for multiplicity. P-values \<0.05 were considered statistically significant.|Mixed Model Repeated Measures Analysis|Fixed effects were Treatment, Visit, Country, Treatment-by-Visit. Participants and Error were Random Effects. Covariance structure was Unstructured.||||57.84|-0.47|0.054
72516076|NCT01115738|144563157|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.3||||0.436|TWO_SIDED|95.0|-17.29|39.9||P-value is for 24 hours after prasugrel LD. P-values were not adjusted for multiplicity. P-values \<0.05 were considered statistically significant.|Mixed Model Repeated Measures Analysis|Fixed effects were Treatment, Visit, Country, Treatment-by-Visit. Participants and Error were Random Effects. Covariance structure was Unstructured.||||39.90|-17.29|0.436
72404261|NCT00116831|144315165|SUPERIORITY_OR_OTHER||Ratio to GLP as % difference from GLP|30.591||||||95.0||||||||||||
72404262|NCT00116831|144315166|SUPERIORITY_OR_OTHER||Treatment difference (RSG-GLP)|7.642||||||95.0||||||||||||
72404263|NCT00116831|144315167|SUPERIORITY_OR_OTHER||Treatment difference (RSG-GLP)|7.316||||||95.0||||||||||||
72404264|NCT00116831|144315168|SUPERIORITY_OR_OTHER||Treatment difference (RSG-GLP)|15.731||||||95.0||||||||||||
72404265|NCT00116831|144315169|SUPERIORITY_OR_OTHER||Treatment difference (RSG-GLP)|3.998||||||95.0||||||||||||
72516077|NCT01115738|144563157|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.87||||0.463|TWO_SIDED|95.0|-14.96|32.71||P-value is for 72 hours after prasugrel LD. P-values were not adjusted for multiplicity. P-values \<0.05 were considered statistically significant.|Mixed Model Repeated Measures Analysis|Fixed effects were Treatment, Visit, Country, Treatment-by-Visit. Participants and Error were Random Effects. Covariance structure was Unstructured.||||32.71|-14.96|0.463
72516078|NCT01115738|144563157|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.34||||0.777|TWO_SIDED|95.0|-26.62|19.94||P-value is for 72 hours after prasugrel LD. P-values were not adjusted for multiplicity. P-values \<0.05 were considered statistically significant.|Mixed Model Repeated Measures Analysis|Fixed effects were Treatment, Visit, Country, Treatment-by-Visit. Participants and Error were Random Effects. Covariance structure was Unstructured.||||19.94|-26.62|0.777
72516079|NCT01115738|144563160|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.31||||0.505|TWO_SIDED|95.0|-13.1|6.48||P-value is for Baseline. P-values were not adjusted for multiplicity. P-values \<0.05 were considered statistically significant.|Mixed Model Repeated Measures Analysis|Fixed effects were Treatment, Visit, Country, Treatment-by-Visit. Participants and Error were Random Effects. Covariance structure was Unstructured.||||6.48|-13.10|0.505
72516080|NCT01115738|144563160|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.23||||0.278|TWO_SIDED|95.0|-14.74|4.27||P-value is for Baseline. P-values were not adjusted for multiplicity. P-values \<0.05 were considered statistically significant.|Mixed Model Repeated Measures Analysis|Fixed effects were Treatment, Visit, Country, Treatment-by-Visit. Participants and Error were Random Effects. Covariance structure was Unstructured.||||4.27|-14.74|0.278
72516081|NCT01115738|144563160|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.71||||0.749|TWO_SIDED|95.0|-19.44|14.02||P-value is for 2 hours after prasugrel LD. P-values were not adjusted for multiplicity. P-values \<0.05 were considered statistically significant.|Mixed Model Repeated Measures Analysis|Fixed effects were Treatment, Visit, Country, Treatment-by-Visit. Participants and Error were Random Effects. Covariance structure was Unstructured.||||14.02|-19.44|0.749
72516082|NCT01115738|144563160|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.15||||0.89|TWO_SIDED|95.0|-15.24|17.53||P-value is for 2 hours after prasugrel LD. P-values were not adjusted for multiplicity. P-values \<0.05 were considered statistically significant.|Mixed Model Repeated Measures Analysis|Fixed effects were Treatment, Visit, Country, Treatment-by-Visit. Participants and Error were Random Effects. Covariance structure was Unstructured.||||17.53|-15.24|0.890
72489083|NCT02819635|144506372|SUPERIORITY||Adjusted risk difference (%)|26.6|||<|0.001|TWO_SIDED|95.0|12.3|40.8||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by previous biologic use, baseline corticosteroid use and baseline Adapted Mayo score (≤ 7 and \> 7)|Difference = Upadacitinib 30 mg - Placebo|Substudy 1: Upadacitinib 30 mg vs Placebo||40.8|12.3|<0.001
72489084|NCT02819635|144506372|SUPERIORITY||Adjusted risk difference (%)|35.4|||<|0.001|TWO_SIDED|95.0|19.2|51.7||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by previous biologic use, baseline corticosteroid use and baseline Adapted Mayo score (≤ 7 and \> 7)|Difference = Upadacitinib 45 mg - Placebo|Substudy 1: Upadacitinib 45 mg vs Placebo||51.7|19.2|<0.001
72516083|NCT01115738|144563160|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.89||||0.223|TWO_SIDED|95.0|-18.02|4.24||P-value is for 6 hours after prasugrel LD. P-values were not adjusted for multiplicity. P-values \<0.05 were considered statistically significant.|Mixed Model Repeated Measures Analysis|Fixed effects were Treatment, Visit, Country, Treatment-by-Visit. Participants and Error were Random Effects. Covariance structure was Unstructured.||||4.24|-18.02|0.223
72516084|NCT01115738|144563160|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.33||||0.808|TWO_SIDED|95.0|-9.44|12.1||P-value is for 6 hours after prasugrel LD. P-values were not adjusted for multiplicity. P-values \<0.05 were considered statistically significant.|Mixed Model Repeated Measures Analysis|Fixed effects were Treatment, Visit, Country, Treatment-by-Visit. Participants and Error were Random Effects. Covariance structure was Unstructured.||||12.10|-9.44|0.808
72516085|NCT01115738|144563160|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.07||||0.049|TWO_SIDED|95.0|-20.11|-0.04||P-value is for 24 hours after prasugrel LD. P-values were not adjusted for multiplicity. P-values \<0.05 were considered statistically significant.|Mixed Model Repeated Measures Analysis|Fixed effects were Treatment, Visit, Country, Treatment-by-Visit. Participants and Error were Random Effects. Covariance structure was Unstructured.||||-0.04|-20.11|0.049
72516086|NCT01115738|144563160|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.99||||0.842|TWO_SIDED|95.0|-10.85|8.86||P-value is for 24 hours after prasugrel LD. P-values were not adjusted for multiplicity. P-values \<0.05 were considered statistically significant.|Mixed Model Repeated Measures Analysis|Fixed effects were Treatment, Visit, Country, Treatment-by-Visit. Participants and Error were Random Effects. Covariance structure was Unstructured.||||8.86|-10.85|0.842
72516087|NCT01115738|144563160|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.03||||0.247|TWO_SIDED|95.0|-13.58|3.52||P-value is for 72 hours after prasugrel LD. P-values were not adjusted for multiplicity. P-values \<0.05 were considered statistically significant.|Mixed Model Repeated Measures Analysis|Fixed effects were Treatment, Visit, Country, Treatment-by-Visit. Participants and Error were Random Effects. Covariance structure was Unstructured.||||3.52|-13.58|0.247
72624347|NCT00863304|144778630|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.08||0.102|TWO_SIDED|95.0|-0.29|0.03||P-value was based on pairwise comparisons.|ANCOVA|||Week 4: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||0.03|-0.29|0.102
72404266|NCT00116831|144315170|SUPERIORITY_OR_OTHER||Treatment difference (RSG-GLP)|11.728||||||95.0||||||||||||
72489085|NCT02819635|144506373|SUPERIORITY||Adjusted risk difference (%)|11.0||||0.021|TWO_SIDED|95.0|1.7|20.4||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by previous biologic use, baseline corticosteroid use and baseline Adapted Mayo score (≤ 7 and \> 7)|Difference = Upadacitinib 7.5 mg - Placebo|Substudy 1: Upadacitinib 7.5 mg vs Placebo||20.4|1.7|0.021
72489086|NCT02819635|144506373|SUPERIORITY||Adjusted risk difference (%)|9.6||||0.024|TWO_SIDED|95.0|1.3|18.0||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by previous biologic use, baseline corticosteroid use and baseline Adapted Mayo score (≤ 7 and \> 7)|Difference = Upadacitinib 15 mg - Placebo|Substudy 1: Upadacitinib 15 mg vs Placebo||18.0|1.3|0.024
72489087|NCT02819635|144506373|SUPERIORITY||Adjusted risk difference (%)|12.2||||0.015|TWO_SIDED|95.0|2.3|22.0||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by previous biologic use, baseline corticosteroid use and baseline Adapted Mayo score (≤ 7 and \> 7)|Difference = Upadacitinib 30 mg - Placebo|Substudy 1: Upadacitinib 30 mg vs Placebo||22.0|2.3|0.015
72489088|NCT02819635|144506373|SUPERIORITY||Adjusted risk difference (%)|20.1||||0.001|TWO_SIDED|95.0|8.0|32.1||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by previous biologic use, baseline corticosteroid use and baseline Adapted Mayo score (≤ 7 and \> 7)|Difference = Upadacitinib 45 mg - Placebo|Substudy 1: Upadacitinib 45 mg vs Placebo||32.1|8.0|0.001
72489089|NCT02819635|144506374|SUPERIORITY||Adjusted risk difference (%)|16.7||||0.038|TWO_SIDED|95.0|0.9|32.5||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by previous biologic use, baseline corticosteroid use and baseline Adapted Mayo score (≤ 7 and \> 7)|Difference = Upadacitinib 7.5 mg - Placebo|Substudy 1: Upadacitinib 7.5 mg vs Placebo||32.5|0.9|0.038
72489090|NCT02819635|144506374|SUPERIORITY||Adjusted risk difference (%)|35.2|||<|0.001|TWO_SIDED|95.0|17.5|52.8||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by previous biologic use, baseline corticosteroid use and baseline Adapted Mayo score (≤ 7 and \> 7)|Difference = Upadacitinib 15 mg - Placebo|Substudy 1: Upadacitinib 15 mg vs Placebo||52.8|17.5|<0.001
72489091|NCT02819635|144506374|SUPERIORITY||Adjusted risk difference (%)|33.6|||<|0.001|TWO_SIDED|95.0|16.3|50.8||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by previous biologic use, baseline corticosteroid use and baseline Adapted Mayo score (≤ 7 and \> 7)|Difference = Upadacitinib 30 mg - Placebo|Substudy 1: Upadacitinib 30 mg vs Placebo||50.8|16.3|<0.001
72516088|NCT01115738|144563160|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.31||||0.942|TWO_SIDED|95.0|-8.09|8.71||P-value is for 72 hours after prasugrel LD. P-values were not adjusted for multiplicity. P-values \<0.05 were considered statistically significant.|Mixed Model Repeated Measures Analysis|Fixed effects were Treatment, Visit, Country, Treatment-by-Visit. Participants and Error were Random Effects. Covariance structure was Unstructured.||||8.71|-8.09|0.942
72516089|NCT01115738|144563163|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.449||||0.8711|TWO_SIDED|95.0|-38.81|45.71|||ANOVA|||A linear ANOVA model with PRU values at baseline for clopidogrel treated participants as response and CYP2C19 metabolizer status as covariate of main interest.||45.71|-38.81|0.8711
72516090|NCT01115738|144563164|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.714||||0.7875|TWO_SIDED|95.0|-72.78|55.36|||ANOVA|||A linear ANOVA model with PRU values of 6 hours post Prasugrel LD as response and treatment, CYP2C19 metabolizer status, interaction of treatment-by-CYP2C19 metabolizer status as fixed effects.||55.36|-72.78|0.7875
72516091|NCT01115738|144563164|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.435||||0.8913|TWO_SIDED|95.0|-53.23|46.37|||ANOVA|||A linear ANOVA model with PRU values of 6 hours Post-Prasugrel LD as response and treatment, CYP2C19 metabolizer status, interaction of treatment-by-CYP2C19 metabolizer status as fixed effects.||46.37|-53.23|0.8913
72489092|NCT02819635|144506374|SUPERIORITY||Adjusted risk difference (%)|45.1|||<|0.001|TWO_SIDED|95.0|26.2|63.9||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by previous biologic use, baseline corticosteroid use and baseline Adapted Mayo score (≤ 7 and \> 7)|Difference = Upadacitinib 45 mg - Placebo|Substudy 1: Upadacitinib 45 mg vs Placebo||63.9|26.2|<0.001
72489093|NCT02819635|144506375|SUPERIORITY||Adjusted risk difference (%)|5.9||||0.495|TWO_SIDED|95.0|-11.1|22.9||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by previous biologic use, baseline corticosteroid use and baseline Adapted Mayo score (≤ 7 and \> 7)|Difference = Upadacitinib 7.5 mg - Placebo|Substudy 1: Upadacitinib 7.5 mg vs Placebo||22.9|-11.1|0.495
72489094|NCT02819635|144506375|SUPERIORITY||Adjusted risk difference (%)|15.9||||0.074|TWO_SIDED|95.0|-1.6|33.4||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by previous biologic use, baseline corticosteroid use and baseline Adapted Mayo score (≤ 7 and \> 7)|Difference = Upadacitinib 15 mg - Placebo|Substudy 1: Upadacitinib 15 mg vs Placebo||33.4|-1.6|0.074
72489095|NCT02819635|144506375|SUPERIORITY||Adjusted risk difference (%)|19.2||||0.033|TWO_SIDED|95.0|1.6|36.9||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by previous biologic use, baseline corticosteroid use and baseline Adapted Mayo score (≤ 7 and \> 7)|Difference = Upadacitinib 30 mg - Placebo|Substudy 1: Upadacitinib 30 mg vs Placebo||36.9|1.6|0.033
72489096|NCT02819635|144506375|SUPERIORITY||Adjusted risk difference (%)|40.1|||<|0.001|TWO_SIDED|95.0|20.5|59.7||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by previous biologic use, baseline corticosteroid use and baseline Adapted Mayo score (≤ 7 and \> 7)|Difference = Upadacitinib 45 mg - Placebo|Substudy 1: Upadacitinib 45 mg vs Placebo||59.7|20.5|<0.001
72489097|NCT02819635|144506376|SUPERIORITY||LS Mean Difference|-2.142|||<|0.001|TWO_SIDED|95.0|-3.2323|-1.052||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|ANCOVA|Stratified by previous biologic use, Baseline corticosteroid use, Baseline Adapted Mayo score (\<= 7 and \> 7)), and Baseline value as covariate.|Difference = Upadacitinib 7.5 mg - Placebo|Substudy 1: Upadacitinib 7.5 mg vs Placebo||-1.0520|-3.2323|<0.001
72516092|NCT01115738|144563164|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.7||||0.6229|TWO_SIDED|95.0|-35.43|58.83|||ANOVA|||A linear ANOVA model with PRU values of 6 hours Post-Prasugrel LD as response and treatment, CYP2C19 metabolizer status, interaction of treatment-by-CYP2C19 metabolizer status as fixed effects.||58.83|-35.43|0.6229
72516093|NCT01714817|144563173|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.08||||0.7264|TWO_SIDED|95.0|0.7077|1.6421|||Stratified logistic regression||Abatacept IV:Placebo IV 95%CI for Odds Ratio|||1.6421|0.7077|0.7264
72516094|NCT01714817|144563174|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.81|||||TWO_SIDED|95.0|0.4148|1.5956|||||Abatacept IV:Placebo IV|||1.5956|0.4148|
72516095|NCT01714817|144563175|SUPERIORITY_OR_OTHER_LEGACY||Adjusted mean difference|-0.17||||0.571|TWO_SIDED|95.0|-0.76|0.42|||Mixed Models Analysis||Adjusted mean difference from placebo|||0.42|-0.76|0.571
72516096|NCT01714817|144563176|SUPERIORITY_OR_OTHER_LEGACY||Adjusted mean difference|-0.09||||0.561|TWO_SIDED|95.0|-0.41|0.22|||Mixed Models Analysis||Adjusted mean difference from placebo|||0.22|-0.41|0.561
72516097|NCT01714817|144563179|SUPERIORITY||Estimate of Difference|1.651|||||TWO_SIDED|95.0|-7.595828|10.897784||||||CR - Day 365||10.897784|-7.595828|
72516098|NCT01714817|144563179|SUPERIORITY||Estimate of Difference|-0.8828|||||TWO_SIDED|95.0|-8.848056|7.082461||||||PR - Day 365||7.082461|-8.848056|
72516099|NCT01714817|144563179|SUPERIORITY||Estimate of Difference|-0.7682|||||TWO_SIDED|95.0|-10.446714|8.910353||||||NR - Day 365||8.910353|-10.446714|
72516100|NCT01714817|144563188|SUPERIORITY|Day 365|Hazard Ratio (HR)|1.43|||||TWO_SIDED|95.0|0.3251|6.2849||||||||6.2849|0.3251|
72624348|NCT00863304|144778630|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.08||0.066|TWO_SIDED|95.0|-0.31|0.01||P-value was based on pairwise comparisons.|ANCOVA|||Week 4: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||0.01|-0.31|0.066
72624349|NCT00863304|144778630|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.44|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-0.6|-0.28||P-value was based on pairwise comparisons.|ANCOVA|||Week 8: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.28|-0.60|<0.001
72516101|NCT01714817|144563188|SUPERIORITY|Day 729|Estimate of Difference vs Drug|3.4|||||TWO_SIDED|95.0|-8.4|15.1||||||||15.1|-8.4|
72516102|NCT01714817|144563208|SUPERIORITY||Estimate of Difference|-0.9682|||||TWO_SIDED|95.0|-4.760178|2.823876||||||Lupus treatment failure - Day 365||2.823876|-4.760178|
72516103|NCT01714817|144563208|SUPERIORITY||Estimate of Difference|-0.4707|||||TWO_SIDED|95.0|-4.588691|3.647365||||||Overall treatment failure - Day 365||3.647365|-4.588691|
72516104|NCT01714817|144563208|SUPERIORITY|Lupus treatment failure - Day 729|Estimate of Difference|0.8|||||TWO_SIDED|95.0|-4.5|6.1||||||||6.1|-4.5|
72516105|NCT01714817|144563208|SUPERIORITY|Overall treatment failure - Day 729|Estimate of Difference|2.7|||||TWO_SIDED|95.0|-3.3|8.8||||||||8.8|-3.3|
72516106|NCT02921763|144563218|SUPERIORITY||||||=|0.0533|||||||Sign test|||"For the volume calculated from the major and minor axes of ovarian chocolate cyst, the values before treatment initiation and at last observation were compared, frequency of increase and decrease was summarized and the sign test was performed separately in the efficacy analysis set and study completers."||||=0.0533
72489098|NCT02819635|144506376|SUPERIORITY||LS Mean Difference|-2.938|||<|0.001|TWO_SIDED|95.0|-4.0284|-1.8478||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|ANCOVA|Stratified by previous biologic use, Baseline corticosteroid use, Baseline Adapted Mayo score (\<= 7 and \> 7)), and Baseline value as covariate.|Difference = Upadacitinib 15 mg - Placebo|Substudy 1: Upadacitinib 15 mg vs Placebo||-1.8478|-4.0284|<0.001
72489099|NCT02819635|144506376|SUPERIORITY||LS Mean Difference|-3.736|||<|0.001|TWO_SIDED|95.0|-4.8247|-2.647||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|ANCOVA|Stratified by previous biologic use, Baseline corticosteroid use, Baseline Adapted Mayo score (\<= 7 and \> 7)), and Baseline value as covariate.|Difference = Upadacitinib 30 mg - Placebo|Substudy 1: Upadacitinib 30 mg vs Placebo||-2.6470|-4.8247|<0.001
72489100|NCT02819635|144506376|SUPERIORITY||LS Mean Difference|-4.061|||<|0.001|TWO_SIDED|95.0|-5.1252|-2.9974||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|ANCOVA|Stratified by previous biologic use, Baseline corticosteroid use, Baseline Adapted Mayo score (\<= 7 and \> 7)), and Baseline value as covariate.|Difference = Upadacitinib 45 mg - Placebo|Substudy 1: Upadacitinib 45 mg vs Placebo||-2.9974|-5.1252|<0.001
72489101|NCT02819635|144506377|SUPERIORITY||Adjusted risk difference (%)|6.6||||0.075|TWO_SIDED|95.0|-0.7|13.9||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by previous biologic use, baseline corticosteroid use and baseline Adapted Mayo score (≤ 7 and \> 7)|Difference = Upadacitinib 7.5 mg - Placebo|Substudy 1: Upadacitinib 7.5 mg vs Placebo||13.9|-0.7|0.075
72489102|NCT02819635|144506377|SUPERIORITY||Adjusted risk difference (%)|3.8||||0.199|TWO_SIDED|95.0|-2.0|9.6||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by previous biologic use, baseline corticosteroid use and baseline Adapted Mayo score (≤ 7 and \> 7)|Difference = Upadacitinib 15 mg - Placebo|Substudy 1: Upadacitinib 15 mg vs Placebo||9.6|-2.0|0.199
72489103|NCT02819635|144506377|SUPERIORITY||Adjusted risk difference (%)|11.1||||0.015|TWO_SIDED|95.0|2.2|20.0||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by previous biologic use, baseline corticosteroid use and baseline Adapted Mayo score (≤ 7 and \> 7)|Difference = Upadacitinib 30 mg - Placebo|Substudy 1: Upadacitinib 30 mg vs Placebo||20.0|2.2|0.015
72489104|NCT02819635|144506377|SUPERIORITY||Adjusted risk difference (%)|17.8||||0.004|TWO_SIDED|95.0|5.8|29.9||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by previous biologic use, baseline corticosteroid use and baseline Adapted Mayo score (≤ 7 and \> 7)|Difference = Upadacitinib 45 mg - Placebo|Substudy 1: Upadacitinib 45 mg vs Placebo||29.9|5.8|0.004
72516107|NCT02921763|144563220|SUPERIORITY||||||=|0.7328|||||||Wilcoxon (Mann-Whitney)|||"For the volume calculated from the major and minor axes of ovarian chocolate cyst (a total volume if there were two or more cysts), the value, difference from the value before treatment and change rate were calculated using the summary statistics at each measurement point and last observation in each analysis set, namely efficacy analysis set and study completers, and the Wilcoxon signed-rank test was performed for the difference and change rate."||||=0.7328
72516108|NCT02921763|144563220|SUPERIORITY||||||=|0.1193|||||||Wilcoxon (Mann-Whitney)|||"For the volume calculated from the major and minor axes of ovarian chocolate cyst (a total volume if there were two or more cysts), the value, difference from the value before treatment and change rate were calculated using the summary statistics at each measurement point and last observation in each analysis set, namely efficacy analysis set and study completers, and the Wilcoxon signed-rank test was performed for the difference and change rate."||||=0.1193
72516109|NCT02921763|144563221|SUPERIORITY|||||||0.7221|||||||Wilcoxon (Mann-Whitney)|||"For the volume calculated from the major and minor axes of ovarian chocolate cyst (a total volume if there were two or more cysts), the value, difference from the value before treatment and change rate were calculated using the summary statistics at each measurement point and last observation in each analysis set, namely efficacy analysis set and study completers, and the Wilcoxon signed-rank test was performed for the difference and change rate."||||0.7221
72404267|NCT00116831|144315171|SUPERIORITY_OR_OTHER||Treatment difference (RSG-GLP)|-6.768||||||95.0||||||||||||
72489105|NCT02819635|144506378|SUPERIORITY||Adjusted risk difference (%)|25.6||||0.003|TWO_SIDED|95.0|8.9|42.3||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by previous biologic use, baseline corticosteroid use and baseline Adapted Mayo score (≤ 7 and \> 7)|Difference = Upadacitinib 7.5 mg - Placebo|Substudy 1: Upadacitinib 7.5 mg vs Placebo||42.3|8.9|0.003
72404268|NCT00116831|144315172|SUPERIORITY_OR_OTHER||Treatment difference (RSG-GLP)|-14.478||||||95.0||||||||||||
72404269|NCT00116831|144315173|SUPERIORITY_OR_OTHER||Treatment difference (RSG-GLP)|-0.462||||||95.0||||||||||||
72404270|NCT00116831|144315174|SUPERIORITY_OR_OTHER||Treatment difference (RSG-GLP)|0.0164||||||95.0||||||||||||
72516110|NCT02921763|144563221|SUPERIORITY|||||||0.0861|||||||Wilcoxon (Mann-Whitney)|||"For the volume calculated from the major and minor axes of ovarian chocolate cyst (a total volume if there were two or more cysts), the value, difference from the value before treatment and change rate were calculated using the summary statistics at each measurement point and last observation in each analysis set, namely efficacy analysis set and study completers, and the Wilcoxon signed-rank test was performed for the difference and change rate."||||0.0861
72516111|NCT02921763|144563225|SUPERIORITY||||||=|0.002|||||||Wilcoxon (Mann-Whitney)|||The score value and difference from the value before treatment were calculated at the same points using the summary statistics, and the Wilcoxon signed-rank test was performed.||||=0.0020
72516112|NCT02921763|144563225|SUPERIORITY||||||=|0.0001|||||||Wilcoxon (Mann-Whitney)|||The score value and difference from the value before treatment were calculated at the same points using the summary statistics, and the Wilcoxon signed-rank test was performed.||||=0.0001
72516113|NCT02921763|144563225|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||The score value and difference from the value before treatment were calculated at the same points using the summary statistics, and the Wilcoxon signed-rank test was performed.||||<0.0001
72516114|NCT02921763|144563225|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||The score value and difference from the value before treatment were calculated at the same points using the summary statistics, and the Wilcoxon signed-rank test was performed.||||<0.0001
72516115|NCT02921763|144563225|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||The score value and difference from the value before treatment were calculated at the same points using the summary statistics, and the Wilcoxon signed-rank test was performed.||||<0.0001
72516116|NCT02921763|144563226|SUPERIORITY||||||=|0.0024|||||||Wilcoxon (Mann-Whitney)|||The difference from the value before treatment and change rate were calculated using the summary statistics at each observation point and last observation, and the Wilcoxon signed-rank test was performed for the difference and change rate.||||=0.0024
72624350|NCT00863304|144778630|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.37|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-0.53|-0.21||P-value was based on pairwise comparisons.|ANCOVA|||Week 8: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.21|-0.53|<0.001
72624351|NCT00863304|144778630|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.08||0.027|TWO_SIDED|95.0|-0.34|-0.02||P-value was based on pairwise comparisons.|ANCOVA|||Week 8: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.02|-0.34|0.027
72489106|NCT02819635|144506378|SUPERIORITY||Adjusted risk difference (%)|43.6|||<|0.001|TWO_SIDED|95.0|25.4|61.8||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by previous biologic use, baseline corticosteroid use and baseline Adapted Mayo score (≤ 7 and \> 7)|Difference = Upadacitinib 15 mg - Placebo|Substudy 1: Upadacitinib 15 mg vs Placebo||61.8|25.4|<0.001
72489107|NCT02819635|144506378|SUPERIORITY||Adjusted risk difference (%)|39.4|||<|0.001|TWO_SIDED|95.0|21.3|57.5||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by previous biologic use, baseline corticosteroid use and baseline Adapted Mayo score (≤ 7 and \> 7)|Difference = Upadacitinib 30 mg - Placebo|Substudy 1: Upadacitinib 30 mg vs Placebo||57.5|21.3|<0.001
72489108|NCT02819635|144506378|SUPERIORITY||Adjusted risk difference (%)|43.1|||<|0.001|TWO_SIDED|95.0|24.4|61.9||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by previous biologic use, baseline corticosteroid use and baseline Adapted Mayo score (≤ 7 and \> 7)|Difference = Upadacitinib 45 mg - Placebo|Substudy 1: Upadacitinib 45 mg vs Placebo||61.9|24.4|<0.001
72516117|NCT02921763|144563226|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||The difference from the value before treatment and change rate were calculated using the summary statistics at each observation point and last observation, and the Wilcoxon signed-rank test was performed for the difference and change rate.||||<0.0001
72516118|NCT02921763|144563226|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||The difference from the value before treatment and change rate were calculated using the summary statistics at each observation point and last observation, and the Wilcoxon signed-rank test was performed for the difference and change rate.||||<0.0001
72516119|NCT02921763|144563226|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||The difference from the value before treatment and change rate were calculated using the summary statistics at each observation point and last observation, and the Wilcoxon signed-rank test was performed for the difference and change rate.||||<0.0001
72624352|NCT00863304|144778630|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.26|STANDARD_ERROR_OF_MEAN|0.08||0.001|TWO_SIDED|95.0|-0.42|-0.1||P-value was based on pairwise comparisons.|ANCOVA|||Week 8: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.10|-0.42|0.001
72404271|NCT00116831|144315175|SUPERIORITY_OR_OTHER||Treatment difference (RSG-GLP)|0.118||||||95.0||||||||||||
72404272|NCT00116831|144315176|SUPERIORITY_OR_OTHER||Treatment difference (RSG-GLP)|0.14||||||95.0||||||||||||
72516120|NCT02921763|144563226|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||The difference from the value before treatment and change rate were calculated using the summary statistics at each observation point and last observation, and the Wilcoxon signed-rank test was performed for the difference and change rate.||||<0.0001
72516121|NCT02921763|144563227|SUPERIORITY||||||=|0.0037|||||||Wilcoxon (Mann-Whitney)|||The difference from the value before treatment and change rate were calculated using the summary statistics at each observation point and last observation, and the Wilcoxon signed-rank test was performed for the difference and change rate.||||=0.0037
72516122|NCT02921763|144563227|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||The difference from the value before treatment and change rate were calculated using the summary statistics at each observation point and last observation, and the Wilcoxon signed-rank test was performed for the difference and change rate.||||<0.0001
72404273|NCT00380393|144315180|OTHER||Vaccine Efficacy|52.9|||<|0.001|TWO_SIDED|95.0|28.1|69.1|||Regression, Cox||Point estimate of VE was adjusted for site, age, bednet use, area and distance from health center.|Vaccine efficacy against P. falciparum||69.1|28.1|<0.001
72404274|NCT00380393|144315180|OTHER||Vaccine Efficacy|55.0|||<|0.001|TWO_SIDED|95.0|31.4|70.4|||Regression, Cox||Point estimate of VE was not adjusted for site, age, bednet use, area or distance from health center.|Vaccine efficacy against P. falciparum||70.4|31.4|<0.001
72404275|NCT00380393|144315181|OTHER||Vaccine efficacy|54.6|||<|0.001|TWO_SIDED|95.0|31.2|70.0|||Regression, Cox||Point estimate of VE was adjusted for site, age, bednet use, area and distance from health center.|Vaccine efficacy against P. falciparum.||70.0|31.2|<0.001
72489109|NCT02819635|144506379|SUPERIORITY||Adjusted risk difference (%)|29.3|||<|0.001|TWO_SIDED|95.0|22.6|35.9||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by bio-IR status (bio-IR vs. non-bio-IR), Baseline corticosteroid use (yes or no) and Baseline Adapted Mayo score (≤ 7 vs. \> 7)|Difference = Upadacitinib 45 mg - Placebo|Substudy 2: Upadacitinib 45 mg vs Placebo||35.9|22.6|<0.001
72489110|NCT02819635|144506380|SUPERIORITY||Adjusted risk difference (%)|12.7|||<|0.001|TWO_SIDED|95.0|8.4|17.0||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by bio-IR status (bio-IR vs. non-bio-IR), Baseline corticosteroid use (yes or no) and Baseline Adapted Mayo score (≤ 7 vs. \> 7)|Difference = Upadacitinib 45 mg - Placebo|Substudy 2: Upadacitinib 45 mg vs Placebo||17.0|8.4|<0.001
72489111|NCT02819635|144506381|SUPERIORITY||Adjusted risk difference (%)|46.3|||<|0.001|TWO_SIDED|95.0|38.4|54.2||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by bio-IR status (bio-IR vs. non-bio-IR), Baseline corticosteroid use (yes or no) and Baseline Adapted Mayo score (≤ 7 vs. \> 7)|Difference = Upadacitinib 45 mg - Placebo|Substudy 2: Upadacitinib 45 mg vs Placebo||54.2|38.4|<0.001
72489112|NCT02819635|144506382|SUPERIORITY||Adjusted risk difference (%)|33.3|||<|0.001|TWO_SIDED|95.0|24.8|41.8||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by bio-IR status (bio-IR vs. non-bio-IR), Baseline corticosteroid use (yes or no) and Baseline Adapted Mayo score (≤ 7 vs. \> 7)||Substudy 2: Upadacitinib 45 mg vs Placebo|Difference = Upadacitinib 45 mg - Placebo|41.8|24.8|<0.001
72489113|NCT02819635|144506383|SUPERIORITY||Adjusted risk difference (%)|23.7|||<|0.001|TWO_SIDED|95.0|17.5|30.0||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by bio-IR status (bio-IR vs. non-bio-IR), Baseline corticosteroid use (yes or no) and Baseline Adapted Mayo score (≤ 7 vs. \> 7)|Difference = Upadacitinib 45 mg - Placebo|Substudy 2: Upadacitinib 45 mg vs Placebo||30.0|17.5|<0.001
72489114|NCT02819635|144506384|SUPERIORITY||Adjusted risk difference (%)|27.4|||<|0.001|TWO_SIDED|95.0|19.2|35.6||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by bio-IR status (bio-IR vs. non-bio-IR), Baseline corticosteroid use (yes or no) and Baseline Adapted Mayo score (≤ 7 vs. \> 7)|Difference = Upadacitinib 45 mg - Placebo|Substudy 2: Upadacitinib 45 mg vs Placebo||35.6|19.2|<0.001
72489115|NCT02819635|144506385|SUPERIORITY||Adjusted risk difference (%)|23.6|||<|0.001|TWO_SIDED|95.0|15.1|32.1||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by bio-IR status (bio-IR vs. non-bio-IR), Baseline corticosteroid use (yes or no) and Baseline Adapted Mayo score (≤ 7 vs. \> 7)|Difference = Upadacitinib 45 mg - Placebo|Substudy 2: Upadacitinib 45 mg vs Placebo||32.1|15.1|<0.001
72516123|NCT02921763|144563227|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||The difference from the value before treatment and change rate were calculated using the summary statistics at each observation point and last observation, and the Wilcoxon signed-rank test was performed for the difference and change rate.||||<0.0001
72516124|NCT02921763|144563227|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||The difference from the value before treatment and change rate were calculated using the summary statistics at each observation point and last observation, and the Wilcoxon signed-rank test was performed for the difference and change rate.||||<0.0001
72516125|NCT02921763|144563227|SUPERIORITY||||||=|0.0003|||||||Wilcoxon (Mann-Whitney)|||The difference from the value before treatment and change rate were calculated using the summary statistics at each observation point and last observation, and the Wilcoxon signed-rank test was performed for the difference and change rate.||||=0.0003
72404276|NCT00380393|144315181|OTHER||Vaccine efficacy|56.5|||<|0.001|TWO_SIDED|95.0|34.2|71.2|||Regression, Cox||Point estimate of VE was not adjusted for site, age, bednet use, area or distance from health center.|Vaccine efficacy against P. falciparum.||71.2|34.2|<0.001
72404277|NCT00380393|144315182|OTHER||Vaccine efficacy|55.8||||0.0003|TWO_SIDED|95.0|31.0|71.7|||Regression, Cox||Point estimate of VE was adjusted for site, age, bednet use, area and distance from health center.|Vaccine efficacy against P. falciparum.||71.7|31.0|0.0003
72404278|NCT00380393|144315182|OTHER||Vaccine efficacy|57.9|||<|0.001|TWO_SIDED|95.0|34.3|73.0|||Regression, Cox||Point estimate of VE was not adjusted for site, age, bednet use, area and distance from health center.|Vaccine efficacy against P. falciparum.||73.0|34.3|<0.001
72404279|NCT00380393|144315183|OTHER||Vaccine efficacy|58.0|||<|0.001|TWO_SIDED|95.0|34.8|73.0|||Regression, Cox||Point estimate of VE was adjusted for site, age, bednet use, area and distance from health center.|Vaccine efficacy against P. falciparum.||73.0|34.8|<0.001
72404280|NCT00380393|144315183|OTHER||Vaccine efficacy|59.5|||<|0.001|TWO_SIDED|95.0|37.1|73.9|||Regression, Cox||Point estimate of VE was not adjusted for site, age, bednet use, area and distance from health center.|Vaccine efficacy against P. falciparum.||73.9|37.1|<0.001
72404281|NCT01933048|144315202|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|non-inferiority||||||0.43|||||||Farrington-Manning Method|based on margin of 0.05||A/H1N1||||0.43
72404282|NCT01933048|144315202|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|non-inferiority||||||0.8|||||||Farrington-Manning Method|based on margin of 0.05||A/H3N2||||0.80
72489116|NCT02819635|144506386|SUPERIORITY||Adjusted risk difference (%)|32.2|||<|0.001|TWO_SIDED|95.0|23.8|40.7||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by bio-IR status (bio-IR vs. non-bio-IR), Baseline corticosteroid use (yes or no) and Baseline Adapted Mayo score (≤ 7 vs. \> 7)|Difference = Upadacitinib 45 mg - Placebo|Substudy 2: Upadacitinib 45 mg vs Placebo||40.7|23.8|<0.001
72489117|NCT02819635|144506387|SUPERIORITY||Least Squares (LS) Mean Difference|33.7|STANDARD_ERROR_OF_MEAN|3.39|<|0.001|TWO_SIDED|95.0|27.02|40.36||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Mixed-effect model repeated measurement|MMRM with Baseline, treatment, visit, treatment-by-visit interaction, and strata (Baseline Adapted Mayo score, corticosteroid use, and bio-IR status).|Difference = Upadacitinib 45 mg - Placebo|Substudy 2: Upadacitinib 45 mg vs Placebo||40.36|27.02|<0.001
72489118|NCT02819635|144506388|SUPERIORITY||Adjusted risk difference (%)|9.7|||<|0.001|TWO_SIDED|95.0|5.7|13.7||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by Baseline corticosteroid use (yes or no), Baseline Adapted Mayo score (≤ 7 or \> 7), and bio-IR status (bio-IR or non-bio-IR)|Difference = Upadacitinib 45 mg - Placebo|Substudy 2: Upadacitinib 45 mg vs Placebo||13.7|5.7|<0.001
72489119|NCT02819635|144506389|SUPERIORITY||Least Squares (LS) Mean Difference|6.7|STANDARD_ERROR_OF_MEAN|0.97|<|0.001|TWO_SIDED|95.0|4.79|8.59||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Mixed-effect model repeated measurement|MMRM with Baseline, treatment, visit, treatment-by-visit interaction, and strata (Baseline Adapted Mayo score, corticosteroid use, and bio-IR status)|Difference = Upadacitinib 45 mg - Placebo|Substudy 2: Upadacitinib 45 mg vs Placebo||8.59|4.79|<0.001
72489120|NCT02819635|144506390|SUPERIORITY||Adjusted risk difference (%)|34.4|||<|0.001|TWO_SIDED|95.0|25.1|43.7||The primary and ranked secondary efficacy endpoints were tested with graphical multiplicity adjustment to ensure a strong control of family-wise type I error rate at significance level α= 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by Bio-IR (Bio-IR/Non-Bio-IR) at Induction Study Baseline; clinical remission at Week 0 (yes/no); corticosteroid use at Week 0 (yes/no)|Difference = Upadacitinib 15 mg - Placebo|Substudy 3: Upadacitinib 15 mg vs Placebo||43.7|25.1|<0.001
72489121|NCT02819635|144506390|SUPERIORITY||Adjusted risk difference (%)|46.3|||<|0.001|TWO_SIDED|95.0|36.7|55.8||The primary and ranked secondary efficacy endpoints were tested with graphical multiplicity adjustment to ensure a strong control of family-wise type I error rate at significance level α= 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by Bio-IR (Bio-IR/Non-Bio-IR) at Induction Study Baseline; clinical remission at Week 0 (yes/no); corticosteroid use at Week 0 (yes/no)|Difference = Upadacitinib 30 mg - Placebo|Substudy 3: Upadacitinib 30 mg vs Placebo||55.8|36.7|<0.001
72516126|NCT02921763|144563228|SUPERIORITY||||||=|0.8035|||||||Wilcoxon (Mann-Whitney)|||"Separately in the efficacy analysis set and study completers, the values before treatment initiation and at last observation were compared, the value, difference from the value before treatment and change rate were calculated using the summary statistics, and the Wilcoxon signed-rank test was performed for the difference and change rate."||||=0.8035
72516127|NCT02921763|144563229|SUPERIORITY||||||=|0.8185|||||||Wilcoxon (Mann-Whitney)|||"Separately in the efficacy analysis set and study completers, the values before treatment initiation and at last observation were compared, the value, difference from the value before treatment and change rate were calculated using the summary statistics, and the Wilcoxon signed-rank test was performed for the difference and change rate."||||=0.8185
72624353|NCT00863304|144778630|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.08||0.02|TWO_SIDED|95.0|-0.35|-0.03||P-value was based on pairwise comparisons.|ANCOVA|||Week 8: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.03|-0.35|0.020
72624354|NCT00863304|144778630|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.33|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-0.49|-0.17||P-value was based on pairwise comparisons.|ANCOVA|||Week 12: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.17|-0.49|<0.001
72404283|NCT01933048|144315202|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|non-inferiority||||||0.55|||||||Farrington-Manning Method|based on margin of 0.05||B/Yamagata||||0.55
72404284|NCT01933048|144315202|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|non-inferiority||||||0.16|||||||Farrington-Manning Method|based on margin of 0.05||B/Brisbane||||0.16
72404285|NCT00110812|144315207|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|134.0|||<|0.001|TWO_SIDED|95.0|70.0|198.0||Adjusted for 3 pairwise comparisons.|ANOVA|stratified by geographic region and adjusted for baseline CD4.||||198|70|<.001
72404286|NCT00110812|144315207|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|133.0|||<|0.001|TWO_SIDED|95.0|68.0|199.0||Adjusted for 3 pairwise comparisons.|ANOVA|stratified by geographic region and adjusted for baseline CD4.||||199|68|<.001
72404287|NCT00110812|144315209|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.31||||0.01|TWO_SIDED|95.0|0.08|0.54|||ANOVA|stratified by region and adjusted for baseline HIV-RNA.||||.54|.08|.01
72489122|NCT02819635|144506391|SUPERIORITY||Adjusted risk difference (%)|37.4|||<|0.001|TWO_SIDED|95.0|20.3|54.6||The primary and ranked secondary efficacy endpoints were tested with graphical multiplicity adjustment to ensure a strong control of family-wise type I error rate at significance level α= 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by Bio-IR (Bio-IR/Non-Bio-IR) at Induction Study Baseline; clinical remission at Week 0 (yes/no); corticosteroid use at Week 0 (yes/no)|Difference = Upadacitinib 15 mg - Placebo|Substudy 3: Upadacitinib 15 mg vs Placebo||54.6|20.3|<0.001
72489123|NCT02819635|144506391|SUPERIORITY||Adjusted risk difference (%)|47.0|||<|0.001|TWO_SIDED|95.0|30.7|63.3||The primary and ranked secondary efficacy endpoints were tested with graphical multiplicity adjustment to ensure a strong control of family-wise type I error rate at significance level α= 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by Bio-IR (Bio-IR/Non-Bio-IR) at Induction Study Baseline; clinical remission at Week 0 (yes/no); corticosteroid use at Week 0 (yes/no)|Difference = Upadacitinib 30 mg - Placebo|Substudy 3: Upadacitinib 30 mg vs Placebo||63.3|30.7|<0.001
72404288|NCT00110812|144315209|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.36||||0.003|TWO_SIDED|95.0|0.12|0.6|||ANOVA|stratified by region and adjusted for baseline HIV-RNA.||||.60|.12|.003
72404289|NCT00110812|144315210|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|65.8||||0.009||95.0|||||ANOVA|ANOVA with stratification by region and adjustment for baseline CD4||||||.009
72404290|NCT00110812|144315210|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|58.2||||0.02||95.0|||||ANOVA|stratified by region and adjusted for baseline CD4||||||.02
72516128|NCT02554253|144563257|SUPERIORITY|Pilot study||||||0.23|||||||Fisher Exact|||Raw scores converted to z-scores using published references. Percentage of patients experiencing a decline of \> 1 standard deviation was compared between groups using Fisher's exact test. The outcome of postoperative cognitive dysfunction (POCD) was defined a-priori as a decline of decline of \>1 standard deviation (i.e. z-score decline of \> 1) on at least 2 neurocognitive tests and was compared between groups using Fisher's exact test.||||0.23
72516129|NCT02554253|144563258|SUPERIORITY|||||||0.08|||||||Fisher Exact|||||||0.08
72516130|NCT02554253|144563259|SUPERIORITY|||||||0.31|||||||Chi-squared|||||||0.31
72516131|NCT01998269|144563266|SUPERIORITY_OR_OTHER||correlation coefficient|0.6|||<|0.001|TWO_SIDED||||||Correlation||r= 0.60, p-value\<0.001. P values below 0.05 are considered statistically significant in this study.|We examined correlations between patient scores on the Measure of Medication Self-Management (MeDS) and the 8-item Morisky Medication Adherence questionnaire.||||<.001
72516132|NCT02559206|144563273|SUPERIORITY||LS Mean Difference (Lin-Placebo)|-0.569||||0.0839|TWO_SIDED|95.0|-1.214|0.076|||mixed model repeated measures (MMRM)|||||0.076|-1.214|0.0839
72516133|NCT02559206|144563273|SUPERIORITY||LS Mean Difference (Lin-Placebo)|-0.297||||0.3661|TWO_SIDED|95.0|-0.942|0.348|||MMRM|||||0.348|-0.942|0.3661
72516134|NCT02559206|144563273|SUPERIORITY||LS Mean Difference (Lin-Placebo)|-0.286||||0.3869|TWO_SIDED|95.0|-0.936|0.363|||MMRM|||||0.363|-0.936|0.3869
72516135|NCT02559206|144563273|SUPERIORITY||LS Mean Difference (Lin-Placebo)|-0.771||||0.0199|TWO_SIDED|95.0|-1.419|-0.123|||MMRM|||||-0.123|-1.419|0.0199
72516136|NCT02559206|144563273|SUPERIORITY|||||||0.0276||||||Trend test performed using linear contrast statement for each DR formulation with placebo.|Trend Test|||||||0.0276
72516137|NCT02559206|144563274|SUPERIORITY||LS Mean Difference (Lin-Placebo)|-0.569||||0.0839|TWO_SIDED|95.0|-1.214|0.076|||MMRM|||||0.076|-1.214|0.0839
72516138|NCT02559206|144563274|SUPERIORITY||LS Mean Difference (Lin-Placebo)|-0.455||||0.1669|TWO_SIDED|95.0|-1.102|0.191|||MMRM|||||0.191|-1.102|0.1669
72516139|NCT02559206|144563274|SUPERIORITY||LS Mean Difference (Lin-Placebo)|-0.299||||0.3637|TWO_SIDED|95.0|-0.947|0.348|||MMRM|||||0.348|-0.947|0.3637
72516140|NCT02559206|144563274|SUPERIORITY||LS Mean Difference (Lin-Placebo)|-0.258||||0.4333|TWO_SIDED|95.0|-0.905|0.389|||MMRM|||||0.389|-0.905|0.4333
72516141|NCT02559206|144563274|SUPERIORITY|||||||0.5528||||||Trend test performed using linear contrast statement for each DR formulation with placebo.|Trend Test|||||||0.5528
72516142|NCT02559206|144563275|SUPERIORITY||LS Mean Difference (Lin-Placebo)|0.992||||0.011|TWO_SIDED|95.0|0.228|1.756|||MMRM|||||1.756|0.228|0.0110
72516143|NCT02559206|144563275|SUPERIORITY||LS Mean Difference (Lin-Placebo)|0.048||||0.9013|TWO_SIDED|95.0|-0.716|0.812|||MMRM|||||0.812|-0.716|0.9013
72516144|NCT02559206|144563275|SUPERIORITY||LS Mean Difference (Lin-Placebo)|0.299||||0.4447|TWO_SIDED|95.0|-0.469|1.067|||MMRM|||||1.067|-0.469|0.4447
72516145|NCT02559206|144563275|SUPERIORITY||LS Mean Difference (Lin-Placebo)|0.662||||0.0904|TWO_SIDED|95.0|-0.104|1.428|||MMRM|||||1.428|-0.104|0.0904
72516146|NCT02559206|144563275|SUPERIORITY|||||||0.07||||||Trend test performed using linear contrast statement for each DR formulation with placebo.|Trend Test|||||||0.0700
72516147|NCT02559206|144563276|SUPERIORITY||LS Mean Difference (Lin-Placebo)|0.992||||0.011|TWO_SIDED|95.0|0.228|1.756|||MMRM|||||1.756|0.228|0.0110
72516148|NCT02559206|144563276|SUPERIORITY||LS Mean Difference (Lin-Placebo)|0.161||||0.6801|TWO_SIDED|95.0|-0.604|0.925|||MMRM|||||0.925|-0.604|0.6801
72516149|NCT02559206|144563276|SUPERIORITY||LS Mean Difference (Lin-Placebo)|-0.095||||0.8069|TWO_SIDED|95.0|-0.861|0.67|||MMRM|||||0.670|-0.861|0.8069
72516150|NCT02559206|144563276|SUPERIORITY||LS Mean Difference (Lin-Placebo)|-0.246||||0.5275|TWO_SIDED|95.0|-1.011|0.519|||MMRM|||||0.519|-1.011|0.5275
72404291|NCT00110812|144315213|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|5.08||||0.14|TWO_SIDED|95.0|0.59|43.6|||Regression, Cox|Unadjusted, stratified by region.|Patients taking IL-2 alone compared to patients not taking IL-2.|||43.6|0.59|.14
72404292|NCT00110812|144315213|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|6.56||||0.08|TWO_SIDED|95.0|0.8|53.6|||Regression, Cox|Unadjusted, stratified by region.|Patients taking IL-2 plus pericycle HAART compared to patients not receiving IL-2|||53.6|0.80|.08
72516151|NCT02559206|144563276|SUPERIORITY|||||||0.4201||||||Trend test performed using linear contrast statement for each DR formulation with placebo.|Trend Test|||||||0.4201
72516152|NCT02559206|144563277|SUPERIORITY||Odds Ratio (OR)|1.71||||0.1663|TWO_SIDED|95.0|0.79|3.7|||Cochran-Mantel-Haenszel|||||3.70|0.79|0.1663
72516153|NCT02559206|144563277|SUPERIORITY||Odds Ratio (OR)|1.39||||0.4399|TWO_SIDED|95.0|0.61|3.17|||Cochran-Mantel-Haenszel|||||3.17|0.61|0.4399
72516154|NCT02559206|144563277|SUPERIORITY||Odds Ratio (OR)|1.27||||0.554|TWO_SIDED|95.0|0.57|2.85|||Cochran-Mantel-Haenszel|||||2.85|0.57|0.5540
72516155|NCT02559206|144563277|SUPERIORITY||Odds Ratio (OR)|2.39||||0.0262|TWO_SIDED|95.0|1.1|5.19|||Cochran-Mantel-Haenszel|||||5.19|1.10|0.0262
72489124|NCT02819635|144506392|SUPERIORITY||Adjusted risk difference (%)|35.4|||<|0.001|TWO_SIDED|95.0|18.2|52.7||The primary and ranked secondary efficacy endpoints were tested with graphical multiplicity adjustment to ensure a strong control of family-wise type I error rate at significance level α= 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by Bio-IR (Bio-IR/Non-Bio-IR) at Induction Study Baseline; clinical remission at Week 0 (yes/no); corticosteroid use at Week 0 (yes/no)|Difference = Upadacitinib 15 mg - Placebo|Substudy 3: Upadacitinib 15 mg vs Placebo||52.7|18.2|<0.001
72489125|NCT02819635|144506392|SUPERIORITY||Adjusted risk difference (%)|45.1|||<|0.001|TWO_SIDED|95.0|28.7|61.6||The primary and ranked secondary efficacy endpoints were tested with graphical multiplicity adjustment to ensure a strong control of family-wise type I error rate at significance level α= 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by Bio-IR (Bio-IR/Non-Bio-IR) at Induction Study Baseline; clinical remission at Week 0 (yes/no); corticosteroid use at Week 0 (yes/no)|Difference = Upadacitinib 30 mg - Placebo|Substudy 3: Upadacitinib 30 mg vs Placebo||61.6|28.7|<0.001
72489126|NCT02819635|144506393|SUPERIORITY||Adjusted risk difference (%)|42.0|||<|0.001|TWO_SIDED|95.0|27.8|56.2||The primary and ranked secondary efficacy endpoints were tested with graphical multiplicity adjustment to ensure a strong control of family-wise type I error rate at significance level α= 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by Bio-IR (Bio-IR/Non-Bio-IR) at Induction Study Baseline; clinical remission at Week 0 (yes/no); corticosteroid use at Week 0 (yes/no)|Difference = Upadacitinib 15 mg - Placebo|Substudy 3: Upadacitinib 15 mg vs Placebo||56.2|27.8|<0.001
72489127|NCT02819635|144506393|SUPERIORITY||Adjusted risk difference (%)|48.6|||<|0.001|TWO_SIDED|95.0|35.5|61.7||The primary and ranked secondary efficacy endpoints were tested with graphical multiplicity adjustment to ensure a strong control of family-wise type I error rate at significance level α= 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by Bio-IR (Bio-IR/Non-Bio-IR) at Induction Study Baseline; clinical remission at Week 0 (yes/no); corticosteroid use at Week 0 (yes/no)|Difference = Upadacitinib 30 mg - Placebo|Substudy 3: Upadacitinib 30 mg vs Placebo||61.7|35.5|<0.001
72489128|NCT02819635|144506394|SUPERIORITY||Adjusted risk difference (%)|18.7|||<|0.001|TWO_SIDED|95.0|11.0|26.4||The primary and ranked secondary efficacy endpoints were tested with graphical multiplicity adjustment to ensure a strong control of family-wise type I error rate at significance level α= 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by Bio-IR (Bio-IR/Non-Bio-IR) at Induction Study Baseline; clinical remission at Week 0 (yes/no); corticosteroid use at Week 0 (yes/no)|Difference = Upadacitinib 15 mg - Placebo|Substudy 3: Upadacitinib 15 mg vs Placebo||26.4|11.0|<0.001
72489129|NCT02819635|144506394|SUPERIORITY||Adjusted risk difference (%)|19.4|||<|0.001|TWO_SIDED|95.0|11.7|27.2||The primary and ranked secondary efficacy endpoints were tested with graphical multiplicity adjustment to ensure a strong control of family-wise type I error rate at significance level α= 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by Bio-IR (Bio-IR/Non-Bio-IR) at Induction Study Baseline; clinical remission at Week 0 (yes/no); corticosteroid use at Week 0 (yes/no)|Difference = Upadacitinib 30 mg - Placebo|Substudy 3: Upadacitinib 30 mg vs Placebo||27.2|11.7|<0.001
72489130|NCT02819635|144506395|SUPERIORITY||Adjusted risk difference (%)|44.6|||<|0.001|TWO_SIDED|95.0|34.5|54.7||The primary and ranked secondary efficacy endpoints were tested with graphical multiplicity adjustment to ensure a strong control of family-wise type I error rate at significance level α= 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by Bio-IR (Bio-IR/Non-Bio-IR) at Induction Study Baseline; clinical remission at Week 0 (yes/no); corticosteroid use at Week 0 (yes/no)|Difference = Upadacitinib 15 mg - Placebo|Substudy 3: Upadacitinib 15 mg vs Placebo||54.7|34.5|<0.001
72489131|NCT02819635|144506395|SUPERIORITY||Adjusted risk difference (%)|56.6|||<|0.001|TWO_SIDED|95.0|47.2|66.0||The primary and ranked secondary efficacy endpoints were tested with graphical multiplicity adjustment to ensure a strong control of family-wise type I error rate at significance level α= 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by Bio-IR (Bio-IR/Non-Bio-IR) at Induction Study Baseline; clinical remission at Week 0 (yes/no); corticosteroid use at Week 0 (yes/no)|Difference = Upadacitinib 30 mg - Placebo|Substudy 3: Upadacitinib 30 mg vs Placebo||66.0|47.2|<0.001
72489132|NCT02819635|144506396|SUPERIORITY||Adjusted risk difference (%)|23.8|||<|0.001|TWO_SIDED|95.0|14.8|32.8||The primary and ranked secondary efficacy endpoints were tested with graphical multiplicity adjustment to ensure a strong control of family-wise type I error rate at significance level α= 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by Bio-IR (Bio-IR/Non-Bio-IR) at Induction Study Baseline; clinical remission at Week 0 (yes/no); corticosteroid use at Week 0 (yes/no)|Difference = Upadacitinib 15 mg - Placebo|Substudy 3: Upadacitinib 15 mg vs Placebo||32.8|14.8|<0.001
72489133|NCT02819635|144506396|SUPERIORITY||Adjusted risk difference (%)|37.3|||<|0.001|TWO_SIDED|95.0|27.8|46.8||The primary and ranked secondary efficacy endpoints were tested with graphical multiplicity adjustment to ensure a strong control of family-wise type I error rate at significance level α= 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by Bio-IR (Bio-IR/Non-Bio-IR) at Induction Study Baseline; clinical remission at Week 0 (yes/no); corticosteroid use at Week 0 (yes/no)|Difference = Upadacitinib 30 mg - Placebo|Substudy 3: Upadacitinib 30 mg vs Placebo||46.8|27.8|<0.001
72489134|NCT02819635|144506397|SUPERIORITY||LS Mean Difference|31.3|STANDARD_ERROR_OF_MEAN|4.77|<|0.001|TWO_SIDED|95.0|21.98|40.7||The primary and ranked secondary efficacy endpoints were tested with graphical multiplicity adjustment to ensure a strong control of family-wise type I error rate at significance level α= 0.05 (2-sided).|ANCOVA|Stratified by corticosteroid use at Week 0 (yes/no); clinical remission status at Week 0 (yes/ no); Bio-IR status at Baseline (Bio-IR or Non-Bio-IR)|Difference = Upadacitinib 15 mg - Placebo|Substudy 3: Upadacitinib 15 mg vs Placebo||40.70|21.98|<0.001
72516156|NCT02559206|144563277|SUPERIORITY|||||||0.0249||||||For each DR formulation, the Correlation Test p-values are obtained from the correlation statistic controlling for geographic region.|Correlation test|||||||0.0249
72516157|NCT02559206|144563278|SUPERIORITY||Odds Ratio (OR)|1.71||||0.1663|TWO_SIDED|95.0|0.79|3.7|||Cochran-Mantel-Haenszel|||||3.70|0.79|0.1663
72516158|NCT02559206|144563278|SUPERIORITY||Odds Ratio (OR)|1.13||||0.771|TWO_SIDED|95.0|0.49|2.58|||Cochran-Mantel-Haenszel|||||2.58|0.49|0.7710
72516159|NCT02559206|144563278|SUPERIORITY||Odds Ratio (OR)|1.11||||0.8021|TWO_SIDED|95.0|0.48|2.58|||Cochran-Mantel-Haenszel|||||2.58|0.48|0.8021
72489135|NCT02819635|144506397|SUPERIORITY||LS Mean Difference|41.0|STANDARD_ERROR_OF_MEAN|4.88|<|0.001|TWO_SIDED|95.0|31.39|50.55||The primary and ranked secondary efficacy endpoints were tested with graphical multiplicity adjustment to ensure a strong control of family-wise type I error rate at significance level α= 0.05 (2-sided).|ANCOVA|Stratified by corticosteroid use at Week 0 (yes/no); clinical remission status at Week 0 (yes/ no); Bio-IR status at Baseline (Bio-IR or Non-Bio-IR)|Difference = Upadacitinib 30 mg - Placebo|Substudy 3: Upadacitinib 30 mg vs Placebo||50.55|31.39|<0.001
72489136|NCT02819635|144506398|SUPERIORITY||Adjusted risk difference (%)|13.0|||<|0.001|TWO_SIDED|95.0|6.0|20.0||The primary and ranked secondary efficacy endpoints were tested with graphical multiplicity adjustment to ensure a strong control of family-wise type I error rate at significance level α= 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by Bio-IR (Bio-IR/Non-Bio-IR) at Induction Study Baseline; clinical remission at Week 0 (yes/no); corticosteroid use at Week 0 (yes/no)|Difference = Upadacitinib 15 mg - Placebo|Substudy 3: Upadacitinib 15 mg vs Placebo||20.0|6.0|<0.001
72489137|NCT02819635|144506398|SUPERIORITY||Adjusted risk difference (%)|13.6|||<|0.001|TWO_SIDED|95.0|6.6|20.6||The primary and ranked secondary efficacy endpoints were tested with graphical multiplicity adjustment to ensure a strong control of family-wise type I error rate at significance level α= 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by Bio-IR (Bio-IR/Non-Bio-IR) at Induction Study Baseline; clinical remission at Week 0 (yes/no); corticosteroid use at Week 0 (yes/no)|Difference = Upadacitinib 30 mg - Placebo|Substudy 3: Upadacitinib 30 mg vs Placebo||20.6|6.6|<0.001
72489138|NCT02819635|144506399|SUPERIORITY||Adjusted risk difference (%)|38.7|||<|0.001|TWO_SIDED|95.0|28.9|48.5||The primary and ranked secondary efficacy endpoints were tested with graphical multiplicity adjustment to ensure a strong control of family-wise type I error rate at significance level α= 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by Bio-IR (Bio-IR/Non-Bio-IR) at Induction Study Baseline; clinical remission at Week 0 (yes/no); corticosteroid use at Week 0 (yes/no)|Difference = Upadacitinib 15 mg - Placebo|Substudy 3: Upadacitinib 15 mg vs Placebo||48.5|28.9|<0.001
72489139|NCT02819635|144506399|SUPERIORITY||Adjusted risk difference (%)|45.1|||<|0.001|TWO_SIDED|95.0|35.5|54.8||The primary and ranked secondary efficacy endpoints were tested with graphical multiplicity adjustment to ensure a strong control of family-wise type I error rate at significance level α= 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by Bio-IR (Bio-IR/Non-Bio-IR) at Induction Study Baseline; clinical remission at Week 0 (yes/no); corticosteroid use at Week 0 (yes/no)|Difference = Upadacitinib 30 mg - Placebo|Substudy 3: Upadacitinib 30 mg vs Placebo||54.8|35.5|<0.001
72489140|NCT02819635|144506400|SUPERIORITY||Adjusted risk difference (%)|24.3|||<|0.001|TWO_SIDED|95.0|14.2|34.5||The primary and ranked secondary efficacy endpoints were tested with graphical multiplicity adjustment to ensure a strong control of family-wise type I error rate at significance level α= 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by Bio-IR (Bio-IR/Non-Bio-IR) at Induction Study Baseline; clinical remission at Week 0 (yes/no); corticosteroid use at Week 0 (yes/no)|Difference = Upadacitinib 15 mg - Placebo|Substudy 3: Upadacitinib 15 mg vs Placebo||34.5|14.2|<0.001
72489141|NCT02819635|144506400|SUPERIORITY||Adjusted risk difference (%)|33.7|||<|0.001|TWO_SIDED|95.0|23.6|43.9||The primary and ranked secondary efficacy endpoints were tested with graphical multiplicity adjustment to ensure a strong control of family-wise type I error rate at significance level α= 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by Bio-IR (Bio-IR/Non-Bio-IR) at Induction Study Baseline; clinical remission at Week 0 (yes/no); corticosteroid use at Week 0 (yes/no)|Difference = Upadacitinib 30 mg - Placebo|Substudy 3: Upadacitinib 30 mg vs Placebo||43.9|23.6|<0.001
72489142|NCT02819635|144506401|SUPERIORITY||LS Mean Difference|5.1|||<|0.001|TWO_SIDED|95.0|2.67|7.52||The primary and ranked secondary efficacy endpoints were tested with graphical multiplicity adjustment to ensure a strong control of family-wise type I error rate at significance level α= 0.05 (2-sided).|ANCOVA|Stratified by corticosteroid use at Week 0 (yes/no); clinical remission status at Week 0 (yes/no); Bio-IR status at Baseline (Bio-IR or Non-Bio-IR)|Difference = Upadacitinib 15 mg - Placebo|Substudy 3: Upadacitinib 15 mg vs Placebo||7.52|2.67|<0.001
72489143|NCT02819635|144506401|SUPERIORITY||LS Mean Difference|5.9|||<|0.001|TWO_SIDED|95.0|3.44|8.27||The primary and ranked secondary efficacy endpoints were tested with graphical multiplicity adjustment to ensure a strong control of family-wise type I error rate at significance level α= 0.05 (2-sided).|ANCOVA|Stratified by corticosteroid use at Week 0 (yes/no); clinical remission status at Week 0 (yes/no); Bio-IR status at Baseline (Bio-IR or Non-Bio-IR)|Difference = Upadacitinib 30 mg - Placebo|Substudy 3: Upadacitinib 30 mg vs Placebo||8.27|3.44|<0.001
72489144|NCT04416555|144506415|SUPERIORITY|||||||0.391|||||||Mixed Models Analysis|||||||0.391
72489145|NCT04416555|144506416|SUPERIORITY|||||||0.608|||||||Regression, Linear|||||||0.608
72489146|NCT04416555|144506417|SUPERIORITY|||||||0.768|||||||Mixed Models Analysis|||||||0.768
72516160|NCT02559206|144563278|SUPERIORITY||Odds Ratio (OR)|0.89||||0.8011|TWO_SIDED|95.0|0.37|2.14|||Cochran-Mantel-Haenszel|||||2.14|0.37|0.8011
72489147|NCT04416555|144506418|SUPERIORITY|||||||0.244|||||||Wilcoxon (Mann-Whitney)|||||||0.244
72489148|NCT04416555|144506419|SUPERIORITY|||||||0.191|||||||Wilcoxon (Mann-Whitney)|||||||0.191
72489149|NCT01118273|144506425|SUPERIORITY_OR_OTHER|||||||0.54|||||||ANCOVA|||||||0.54
72489150|NCT01118273|144506426|SUPERIORITY_OR_OTHER|||||||0.31|||||||ANCOVA|||||||0.31
72489151|NCT01118273|144506427|SUPERIORITY_OR_OTHER|||||||0.45|||||||Log Rank|||||||0.45
72489152|NCT01118273|144506428|SUPERIORITY_OR_OTHER|||||||0.001|||||||Cochran-Mantel-Haenszel|||||||0.001
72489153|NCT01118273|144506429|SUPERIORITY_OR_OTHER|||||||0.05|||||||ANCOVA|||||||0.05
72489154|NCT01118273|144506430|SUPERIORITY_OR_OTHER|||||||0.019|||||||ANCOVA|||||||0.019
72489155|NCT01118273|144506431|SUPERIORITY_OR_OTHER|||||||0.018|||||||ANCOVA|||||||0.018
72489156|NCT01118273|144506432|SUPERIORITY_OR_OTHER|||||||0.03|||||||Cochran-Mantel-Haenszel|||||||0.03
72489157|NCT01118273|144506433|SUPERIORITY_OR_OTHER|||||||0.76|||||||Cochran-Mantel-Haenszel|||||||0.76
72489158|NCT01118273|144506434|SUPERIORITY_OR_OTHER|||||||0.015|||||||ANCOVA|||||||0.015
72489159|NCT01118273|144506435|SUPERIORITY_OR_OTHER|||||||0.04|||||||Cochran-Mantel-Haenszel|||||||0.04
72489160|NCT01118273|144506436|SUPERIORITY_OR_OTHER|||||||0.95|||||||ANCOVA|||||||0.95
72489161|NCT01118273|144506437|SUPERIORITY_OR_OTHER|||||||0.05|||||||Cochran-Mantel-Haenszel|||||||0.05
72489162|NCT01118273|144506439|SUPERIORITY_OR_OTHER|||||||0.42|||||||ANCOVA|||||||0.42
72489163|NCT01118273|144506440|SUPERIORITY_OR_OTHER|||||||0.35|||||||ANCOVA|||||||0.35
72489164|NCT01118273|144506441|SUPERIORITY_OR_OTHER|||||||0.35|||||||ANCOVA|||||||0.35
72489165|NCT01118273|144506442|SUPERIORITY_OR_OTHER|||||||0.72|||||||ANCOVA|||||||0.72
72489166|NCT01118273|144506443|SUPERIORITY_OR_OTHER|||||||0.001|||||||Log Rank|||||||0.001
72489167|NCT01118273|144506445|SUPERIORITY_OR_OTHER|||||||0.35|||||||Cochran-Mantel-Haenszel|||||||0.35
72489168|NCT01118273|144506447|SUPERIORITY_OR_OTHER|||||||0.53|||||||ANCOVA|||||||0.53
72489169|NCT01118273|144506448|SUPERIORITY_OR_OTHER|||||||0.55|||||||ANCOVA|||||||0.55
72489170|NCT01118273|144506449|SUPERIORITY_OR_OTHER|||||||0.59|||||||ANCOVA|||||||0.59
72489171|NCT01118273|144506450|SUPERIORITY_OR_OTHER|||||||0.25|||||||ANCOVA|||||||0.25
72489172|NCT01923285|144506458|NON_INFERIORITY|The non-inferiority margin, which is pre-specified at 10%. If non-inferiority is achieved at a one-sided alpha of 0.05, a one-sided superiority test is performed at the significance level of 0.025.|||||<|0.0001||||||The non-inferiority margin, which is pre-specified at 10%. If non-inferiority is achieved at a one-sided alpha of 0.05, a one-sided superiority test is performed at the significance level of 0.025.|Chi-squared|||"The primary hypothesis tested was: H0: p1 ≤ p0 - δ vs. H1: p1\> p0 - δ, where p0 is the success rate in the Control group, p1 is the success rate in the Axium group, and δ is the non-inferiority margin, which is pre-specified at 10%.~If non-inferiority is achieved at a one-sided alpha of 0.05, a one-sided superiority test is performed at the significance level of 0.025."||||<0.0001
72489173|NCT01923285|144506458|SUPERIORITY|The non-inferiority margin, which is pre-specified at 10%. If non-inferiority is achieved at a one-sided alpha of 0.05, a one-sided superiority test is performed at the significance level of 0.025|||||=|0.0004|||||||Chi-squared|||The primary hypothesis tested was: H0: p1 ≤ p0 - δ vs. H1: p1\> p0 - δ, where p0 is the success rate in the Control group, p1 is the success rate in the Axium group, and δ is the non-inferiority margin, which is pre-specified at 10%.||||=0.0004
72489174|NCT01923285|144506459|OTHER|Comparison of the mean difference. Difference in intensities is calculated as the supine paresthesia intensity minus the upright paresthesia intensity.|Mean Difference (Net)|1.9|||<|0.0001|TWO_SIDED|95.0|1.0|2.8|||Wilcoxon (Mann-Whitney)||Difference in paresthesia intensities is calculated as the supine paresthesia score minus the upright paresthesia score for each subject.|"Secondary endpoint compared the mean differences in upright and supine paresthesia scores between the Axium and Control groups at three months post INS implant. This endpoint was evaluated at a two-sided significance level of 0.05.~The primary hypothesis tested was: H0: μ0- μ1≤0 vs. H1: μ0- μ1\>0 where μ0 is the mean difference in paresthesia intensities in the Control group and μ1 is the mean difference in the Axium group."||2.8|1.0|<0.0001
72489175|NCT01923285|144506460|NON_INFERIORITY|If non-inferiority is achieved at a one-sided alpha of 0.05, a one-sided superiority test is performed at the significance level of 0.025.|||||<|0.0001|||||||Chi-squared|||The primary hypothesis tested was: H0: p1 ≤ p0 - δ vs. H1: p1\> p0 - δ, where p0 is the success rate in the Control group, p1 is the success rate in the Axium group, and δ is the non-inferiority margin, which is pre-specified at 10%.||||<0.0001
72489176|NCT01923285|144506460|SUPERIORITY|If non-inferiority is achieved at a one-sided alpha of 0.05, a one-sided superiority test is performed at the significance level of 0.025.|||||=|0.0047|||||||Chi-squared|||||||=0.0047
72489177|NCT01923285|144506461|NON_INFERIORITY|If non-inferiority is achieved at a one-sided alpha of 0.05, a one-sided superiority test is performed at the significance level of 0.025.||||||0.0003|||||||Non-inferiority|||The primary hypothesis tested was: H0: p1 ≤ p0 - δ vs. H1: p1\> p0 - δ, where p0 is the success rate in the Control group, p1 is the success rate in the Axium group, and δ is the non-inferiority margin, which is pre-specified at 10%.||||0.0003
72489178|NCT00330382|144506472|SUPERIORITY_OR_OTHER||Correlation Coefficient|0.11|||>|0.45|TWO_SIDED||||||Spearman Rank Correlation|||Correlation of percent change in buccal-cell Neu with relative percent change in total lesion area||||>0.45
72489179|NCT00330382|144506472|SUPERIORITY_OR_OTHER||Correlation Coefficient|0.92|||>|0.88|TWO_SIDED||||||Spearman Rank Correlation|||Correlation of percent change in protease activity with relative percent change in total lesion area||||> 0.88
72489180|NCT00330382|144506472|SUPERIORITY_OR_OTHER||Correlation Coefficient|0.07|||>|0.66|TWO_SIDED||||||Spearman Rank Correlation|||Correlation of percent change in serum Neu with relative percent change in total lesion area||||> 0.66
72489181|NCT02018822|144506492|NON_INFERIORITY|Assuming that the success rate of the control composite resin is 95% based on clinical data, for a non-inferiority test with a non-inferiority margin of 15%, a sample size of 27 is required in each group to allow 80% power at an alpha level of 0.05. We aimed to have 30 subjects/teeth remaining in each group after attrition at the end of the study.||||||0.2552|||||||Chi-squared|||||||0.2552
72489182|NCT02018822|144506493|NON_INFERIORITY|Assuming that the success rate of the control composite resin is 95% based on clinical data, for a non-inferiority test with a non-inferiority margin of 15%, a sample size of 27 is required in each group to allow 80% power at an alpha level of 0.05. We aimed to have 30 subjects/teeth remaining in each group after attrition at the end of the study.||||||0.2235|||||||Chi-squared|||||||0.2235
72489183|NCT02018822|144506494|NON_INFERIORITY|Assuming that the success rate of the control composite resin is 95% based on clinical data, for a non-inferiority test with a non-inferiority margin of 15%, a sample size of 27 is required in each group to allow 80% power at an alpha level of 0.05. We aimed to have 30 subjects/teeth remaining in each group after attrition at the end of the study.||||||0.3891|||||||Chi-squared|||||||0.3891
72489184|NCT02018822|144506495|NON_INFERIORITY|Assuming that the success rate of the control composite resin is 95% based on clinical data, for a non-inferiority test with a non-inferiority margin of 15%, a sample size of 27 is required in each group to allow 80% power at an alpha level of 0.05. We aimed to have 30 subjects/teeth remaining in each group after attrition at the end of the study.||||||0.3883|||||||Chi-squared|||||||0.3883
72516161|NCT02559206|144563278|SUPERIORITY|||||||0.8578||||||For each DR formulation, the Correlation Test p-values are obtained from the correlation statistic controlling for geographic region.|Correlation test|||||||0.8578
72516162|NCT03532776|144563338|EQUIVALENCE|BE limits: -20.0% to 20.0%|Equivalence ratio|0.98|||||TWO_SIDED|90.0|-12.0|7.0||||||||7|-12|
72568567|NCT04168190|144668500|SUPERIORITY|Superiority can be concluded if the lower bound of the 95% CI for the estimated GMT ratio (V116/PPSV23) is \>1.0 (1-sided p-value \<0.025).|GMT Ratio|9.0|||<|0.001|TWO_SIDED|95.0|7.19|11.26|||P-value is estimated from a cLDA model.||Phase 2: V116/Phase 2: Pneumovax™23|Serotype 35B. Geometric mean titer (GMT) ratio and 95% confidence interval (CI), and p-value are estimated from a constrained longitudinal data analysis (cLDA) model.||11.26|7.19|<0.001
72568568|NCT04168190|144668501|OTHER|Geometric mean concentration (GMC) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMC Ratio|0.91|||||TWO_SIDED|95.0|0.58|1.42|||||Phase 1: V116 0.5 mL/Phase 1: Pneumovax™23|Serotype 3||1.42|0.58|
72624355|NCT00863304|144778630|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.27|STANDARD_ERROR_OF_MEAN|0.08||0.001|TWO_SIDED|95.0|-0.43|-0.11||P-value was based on pairwise comparisons.|ANCOVA|||Week 12: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.11|-0.43|0.001
72624356|NCT00863304|144778630|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.08||0.328|TWO_SIDED|95.0|-0.24|0.08||P-value was based on pairwise comparisons.|ANCOVA|||Week 12: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||0.08|-0.24|0.328
72624357|NCT00863304|144778630|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.25|STANDARD_ERROR_OF_MEAN|0.08||0.002|TWO_SIDED|95.0|-0.41|-0.09||P-value was based on pairwise comparisons.|ANCOVA|||Week 12: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.09|-0.41|0.002
72624358|NCT00863304|144778630|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.08||0.022|TWO_SIDED|95.0|-0.35|-0.03||P-value was based on pairwise comparisons.|ANCOVA|||Week 12: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.03|-0.35|0.022
72489185|NCT02018822|144506496|NON_INFERIORITY|Assuming that the success rate of the control composite resin is 95% based on clinical data, for a non-inferiority test with a non-inferiority margin of 15%, a sample size of 27 is required in each group to allow 80% power at an alpha level of 0.05. We aimed to have 30 subjects/teeth remaining in each group after attrition at the end of the study.||||||0.3883|||||||Chi-squared|||||||0.3883
72489186|NCT02018822|144506497|NON_INFERIORITY|Assuming that the success rate of the control composite resin is 95% based on clinical data, for a non-inferiority test with a non-inferiority margin of 15%, a sample size of 27 is required in each group to allow 80% power at an alpha level of 0.05. We aimed to have 30 subjects/teeth remaining in each group after attrition at the end of the study.||||||0.2707|||||||Chi-squared|||||||0.2707
72489187|NCT03201458|144506498|SUPERIORITY||Hazard Ratio (HR)|0.58||||0.027|TWO_SIDED|90.0|0.35|0.93||One-sided test|Log Rank|||||0.93|0.35|0.027
72489188|NCT03201458|144506499|SUPERIORITY||Odds Ratio (OR)|2.3||||0.22|TWO_SIDED||||||Fisher Exact|||||||0.22
72516163|NCT00654953|144563343|SUPERIORITY_OR_OTHER|||||||0.05|||||||ANOVA|degrees of freedom for medication group = 2 (group)||The analysis tested the null hypothesis of no difference among groups in terms of the # of days to relapse (first two conseqcutively positive urines) using ANOVA.||||0.05
72516164|NCT01231607|144563344|SUPERIORITY_OR_OTHER||Least-squares (LS) mean difference|22.0||||0.046|TWO_SIDED|98.33|-4.4|48.4|||General linear model||Estimates are based on the adjusted (least-squares) means from the general linear model: Change from Baseline = Treatment + Cluster + Baseline Value. The estimation value represents the dutasteride 0.02 mg LS mean minus the placebo LS mean.|||48.4|-4.4|0.046
72516165|NCT01231607|144563344|SUPERIORITY_OR_OTHER||LS mean difference|67.9|||<|0.001|TWO_SIDED|98.33|41.6|94.2|||General linear model||Estimates are based on the adjusted (least-squares) means from the general linear model: Change from Baseline = Treatment + Cluster + Baseline Value. The estimation value represents the dutasteride 0.1 mg LS mean minus the placebo LS mean.|||94.2|41.6|<0.001
72516166|NCT01231607|144563344|SUPERIORITY_OR_OTHER||LS mean difference|94.4|||<|0.001|TWO_SIDED|98.33|67.8|121.0|||General linear model|Each dose of dutasteride independently analyzed for comparison against placebo using a general linear model.|Estimates are based on the adjusted (least-squares) means from the general linear model: Change from Baseline = Treatment + Cluster + Baseline Value. The estimation value represents the dutasteride 0.5 mg LS mean minus the placebo LS mean.|||121.0|67.8|<0.001
72516167|NCT01231607|144563344|SUPERIORITY_OR_OTHER||Least squares mean difference|61.4|||<|0.001|TWO_SIDED|98.33|34.4|88.4|||General linear model||Estimates are based on the adjusted (least-squares) means from the general linear model: Change from Baseline = Treatment + Cluster + Baseline Value. The estimation value represents the finasteride 1 mg LS mean minus the placebo LS mean.|||88.4|34.4|<0.001
72516168|NCT01231607|144563344|NON_INFERIORITY_OR_EQUIVALENCE|Differences between dutasteride (DUT) and finasteride (FIN) were assessed using a general linear model (GLM) adjusted for treatment, cluster, and BL hair count (HC). The one-sided 99.165% confidence interval (CI) for DUT minus FIN was derived, and noninferiority (NI) demonstrated if the lower end of the CI was greater than -35 hairs. If NI was achieved with a dose of DUT, the primary endpoint was to be analyzed for superiority against FIN using a GLM adjusted for treatment, cluster, and BL HC.|Least squares mean difference|-39.4|||<|0.001||99.165|-66.1|-12.7|||General linear model||Estimates are based on the adjusted (least-squares) means from the general linear model: Change from Baseline = Treatment + Cluster + Baseline Value. The estimation value represents the finasteride 1 mg LS mean minus the Dutasteride 0.02 mg LS mean.|||-12.7|-66.1|<0.001
72568569|NCT04168190|144668501|OTHER|Geometric mean concentration (GMC) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMC Ratio|1.12|||||TWO_SIDED|95.0|0.71|1.76|||||Phase 1: V116 1.0 mL/Phase 1: Pneumovax™23|Serotype 3||1.76|0.71|
72568570|NCT04168190|144668501|OTHER|Geometric mean concentration (GMC) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMC Ratio|1.12|||||TWO_SIDED|95.0|0.63|1.99|||||Phase 1: V116 0.5 mL/Phase 1: Pneumovax™23|Serotype 7F||1.99|0.63|
72489189|NCT03201458|144506501|SUPERIORITY|||||||0.41||||||One-sided test|Log Rank|||||||0.410
72489190|NCT04707157|144506511|SUPERIORITY||Posterior Mean Difference|-1.56|||||TWO_SIDED|95.0|-2.76|-0.38|||||Posterior mean difference with 95% credible interval is reported.|||-0.38|-2.76|
72489191|NCT04707157|144506512|SUPERIORITY||Posterior Mean Difference|-1.03|||||TWO_SIDED|95.0|-2.14|0.08|||||Posterior mean difference with 95% credible interval is reported.|||0.08|-2.14|
72489192|NCT04707157|144506513|SUPERIORITY||Posterior Mean Difference|-0.91|||||TWO_SIDED|95.0|-1.56|-0.25|||||Posterior mean difference with 95% credible interval is reported.|||-0.25|-1.56|
72489193|NCT04707157|144506514|SUPERIORITY||Posterior Mean Difference|-1.99|||||TWO_SIDED|95.0|-3.22|-0.77|||||Posterior mean difference with 95% credible interval is reported.|||-0.77|-3.22|
72489194|NCT04707157|144506515|SUPERIORITY||Posterior Mean Difference|-19.12|||||TWO_SIDED|95.0|-31.22|-6.97|||||Posterior mean difference with 95% credible interval is reported.|||-6.97|-31.22|
72489195|NCT04707157|144506516|SUPERIORITY||Posterior Mean Difference|-0.11|||||TWO_SIDED|95.0|-0.86|0.64|||||Posterior mean difference with 95% credible interval is reported.|||0.64|-0.86|
72489196|NCT04707157|144506517|SUPERIORITY||Posterior Mean Difference|-269.92|||||TWO_SIDED|95.0|-624.98|86.24|||||Posterior mean difference with 95% credible interval is reported.|||86.24|-624.98|
72489197|NCT04707157|144506518|SUPERIORITY||Posterior Mean Difference|0.03|||||TWO_SIDED|95.0|-0.22|0.29|||||Posterior mean difference with 95% credible interval is reported.|||0.29|-0.22|
72489198|NCT01389752|144506528|SUPERIORITY_OR_OTHER||Ratio of Geometric Least Squares Means|0.65|||||TWO_SIDED|90.0|0.61|0.68||The outcome was measured as a ratio of geometric means between the two treatments (LY2216684 in combination with activated charcoal/LY2216684 alone), and the 90% Confidence Interval for the ratio.|Mixed Models Analysis|||||0.68|0.61|
72489199|NCT01389752|144506529|SUPERIORITY_OR_OTHER||Ratio of Geometric Least Squares Means|0.9|||||TWO_SIDED|90.0|0.83|0.98||The outcome was measured as a ratio of geometric means between the two treatments (LY2216684 in combination with activated charcoal/LY2216684 alone), and the 90% Confidence Interval for the ratio.|Mixed Models Analysis|||||0.98|0.83|
72489200|NCT01389752|144506530|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.55||||0.001|TWO_SIDED|90.0|-1.04|-0.5||The outcome was measured using the median of paired differences between the 2 treatment groups: LY2216684 administered alone (reference) versus LY2216684 co-administered with charcoal (test).|Wilcoxon (Mann-Whitney)|||||-0.50|-1.04|0.0010
72489201|NCT04251910|144506542|SUPERIORITY|||||||0.0813|||||||Mixed effects model|||Part A-30 mcg BXCL501 V/S Part A-Placebo (2 hours)||||0.0813
72489202|NCT04251910|144506542|SUPERIORITY|||||||0.0011|||||||Mixed effects model|||Part A-60 mcg BXCL501 V/S Part A-Placebo (2 hours)||||0.0011
72568571|NCT04168190|144668501|OTHER|Geometric mean concentration (GMC) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMC Ratio|2.14|||||TWO_SIDED|95.0|1.19|3.84|||||Phase 1: V116 1.0 mL/Phase 1: Pneumovax™23|Serotype 7F||3.84|1.19|
72404293|NCT00110812|144315214|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.58||||0.048|TWO_SIDED|95.0|0.34|0.99|||Regression, Cox||IL-2 without ART vs control group|||.99|.34|.048
72404294|NCT00110812|144315214|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.32|||<|0.001|TWO_SIDED|95.0|0.17|0.62|||Regression, Cox||IL-2 with pericycle HAART compared to control|||.62|.17|<.001
72404295|NCT00110812|144315215|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.34||||0.03|TWO_SIDED|95.0|0.03|0.64|||ANOVA|Stratified by region and adjusted for baseline HIV-RNA||||0.64|0.03|.03
72489203|NCT04251910|144506542|SUPERIORITY|||||||0.0002|||||||Mixed effects model|||Part B-40 mcg-BXCL501 v/s Part B-Placebo (2 hours)||||0.0002
72489204|NCT04251910|144506544|SUPERIORITY|||||||0.9616|||||||Mixed effects model|||Part A 30 mcg BXCL501 v/s Part A-Placebo (30 minutes)||||0.9616
72489205|NCT04251910|144506544|SUPERIORITY|||||||0.546|||||||Mixed effects model|||Part A-30 mcg BXCL501 v/s Part A-Placebo (Day 1; 1 hour)||||0.5460
72489206|NCT04251910|144506544|SUPERIORITY|||||||0.0961|||||||Mixed effects model|||Part A-30 mcg BXCL501 V/s Part A-Placebo (2 hours)||||0.0961
72489207|NCT04251910|144506544|SUPERIORITY|||||||0.1359|||||||Mixed effects model|||Part A-30 mcg BXCL501 v/s Part A-Placebo (4 hours)||||0.1359
72489208|NCT04251910|144506544|SUPERIORITY|||||||0.1688|||||||Mixed effects model|||Part A-30 mcg BXCL501 v/s Part A-Placebo (8 hours)||||0.1688
72489209|NCT04251910|144506544|SUPERIORITY|||||||0.667|||||||Mixed effects model|||Part A-30 mcg BXCL501 v/s Part A-Placebo (24 hours)||||0.6670
72489210|NCT04251910|144506544|SUPERIORITY|||||||0.8695|||||||Mixed effects model|||Part A-30 mcg BXCL501 v/s Part A-Placebo (Day 3)||||0.8695
72489211|NCT04251910|144506544|SUPERIORITY|||||||0.5002|||||||Mixed effects model|||Part A-30 mcg BXCL501 v/s Part A-Placebo (Day 7)||||0.5002
72489212|NCT04251910|144506544|SUPERIORITY|||||||0.5631|||||||Mixed effects model|||Part A-60 mcg BXCL501 v/s Part A-Placebo (30 minutes)||||0.5631
72489213|NCT04251910|144506544|SUPERIORITY|||||||0.0089|||||||Mixed effects model|||Part A-60 mcg BXCL501 v/s Part A-Placebo (1 hour)||||0.0089
72489214|NCT04251910|144506544|SUPERIORITY||||||<|0.0001|||||||Mixed effects model|||Part A-60 mcg BXCL501 v/s Part A-Placebo (2 hours)||||<.0001
72489215|NCT04251910|144506544|SUPERIORITY|||||||0.0011|||||||Mixed effects model|||Part A-60 mcg BXCL501 v/s Part A-Placebo (4 hours)||||0.0011
72489216|NCT04251910|144506544|SUPERIORITY|||||||0.0008|||||||Mixed effects model|||Part A-60 mcg BXCL501 v/s Part A-Placebo (8 hours)||||0.0008
72489217|NCT04251910|144506544|SUPERIORITY|||||||0.2847|||||||Mixed effects model|||Part A-60 mcg BXCL501 v/s Part A-Placebo (24 hours)||||0.2847
72489218|NCT04251910|144506544|SUPERIORITY|||||||0.2616|||||||Mixed effects model|||Part A-60 mcg BXCL501 v/s Part A-Placebo (Day 3)||||0.2616
72489219|NCT04251910|144506544|SUPERIORITY|||||||0.1989|||||||Mixed effects model|||Part A-60 mcg BXCL501 v/s Part A-Placebo (Day 7)||||0.1989
72489220|NCT04251910|144506544|SUPERIORITY|||||||0.4585|||||||Mixed effects model|||Part B-40 mcg-BXCL501 v/s Part B-Placebo (30 minutes)||||0.4585
72489221|NCT04251910|144506544|SUPERIORITY|||||||0.0005|||||||Mixed effects model|||Part B-40 mcg-BXCL501 v/s Part B-Placebo (1 hour)||||0.0005
72489222|NCT04251910|144506544|SUPERIORITY|||||||0.0004|||||||Mixed effects model|||Part B-40 mcg-BXCL501 v/s Part B-Placebo (2 hours)||||0.0004
72489223|NCT04251910|144506544|SUPERIORITY|||||||0.0025|||||||Mixed effects model|||Part B-40 mcg-BXCL501 v/s Part B-Placebo (4 hours)||||0.0025
72489224|NCT04251910|144506544|SUPERIORITY|||||||0.1027|TWO_SIDED|95.0|||||Mixed effects model|||Part B-40 mcg-BXCL501 v/s Part B-Placebo (8 hours)||||0.1027
72489225|NCT04251910|144506544|SUPERIORITY|||||||0.7953|||||||Mixed effects model|||Part B-40 mcg-BXCL501 v/s Part B-Placebo (24 hours)||||0.7953
72489226|NCT04251910|144506544|SUPERIORITY|||||||0.1416|||||||Mixed effects model|||Part B-40 mcg-BXCL501 v/s Part B-Placebo (Day 3)||||0.1416
72489227|NCT04251910|144506544|SUPERIORITY|||||||0.0658|||||||Mixed effects model|||Part B-40 mcg-BXCL501 v/s Part B-Placebo (Day 7)||||0.0658
72489228|NCT04251910|144506545|SUPERIORITY|||||||0.876|||||||Mixed effects model|||Part A -30 mcg BXCL501 v/s Part A-Placebo (Day 1; 1 hour)||||0.8760
72489229|NCT04251910|144506545|SUPERIORITY|||||||0.9077|||||||Mixed effects model|||Part A 30 mcg BXCL501 v/s Part A-Placebo (Day 1; 2 hours)||||0.9077
72489230|NCT04251910|144506545|SUPERIORITY|||||||0.7208|||||||Mixed effects model|||Part A 30 mcg BXCL501 vs Part A-Placebo (Day1; 4 hours)||||0.7208
72489231|NCT04251910|144506545|SUPERIORITY|||||||0.3666|||||||Mixed effects model|||Part A BXCL501 30 mcg v/s Part A-Placebo(Day 1;8 hours)||||0.3666
72489232|NCT04251910|144506545|SUPERIORITY|||||||0.0191|||||||Mixed effects model|||Part A BXCL501 60 mcg v/s Placebo-Part A (Day1; 1 hour)||||0.0191
72489233|NCT04251910|144506545|SUPERIORITY|||||||0.0006|||||||Mixed effects model|||Part A BXCL501 60 mcg v/s Part A-Placebo (Day 1; 2 hours)||||0.0006
72489234|NCT04251910|144506545|SUPERIORITY||||||<|0.0001|||||||Mixed effects model|||Part A-60 mcg BXCL501 v/s Part A-Placebo (Day 1; 4 hours)||||<.0001
72489235|NCT04251910|144506545|SUPERIORITY|||||||0.0003|||||||Mixed effects model|||Part A-60 mcg BXCL501 V/S Part A-Placebo (Day 1;8 hours)||||0.0003
72489236|NCT04251910|144506545|SUPERIORITY|||||||0.0006|||||||Mixed effects model|||Part B-40 mcg-BXCL501 v/s Part B-Placebo (Day 1; 1 hour)||||0.0006
72489237|NCT04251910|144506545|SUPERIORITY|||||||0.0002|||||||Mixed effects model|||Part B-40 mcg-BXCL501 v/s Part B-Placebo (Day 1; 2 hours)||||0.0002
72489238|NCT04251910|144506545|SUPERIORITY|||||||0.0029|||||||Mixed effects model|||Part B-40 mcg-BXCL501 v/s Part B-Placebo (Day 1; 4 hours)||||0.0029
72489239|NCT04251910|144506545|SUPERIORITY|||||||0.2446|||||||Mixed effects model|||Part B-40 mcg-BXCL501 v/s Part B-Placebo (Day 1; 8 hours)||||0.2446
72568572|NCT04168190|144668501|OTHER|Geometric mean concentration (GMC) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMC Ratio|1.27|||||TWO_SIDED|95.0|0.74|2.21|||||Phase 1: V116 0.5 mL/Phase 1: Pneumovax™23|Serotype 19A||2.21|0.74|
72489240|NCT04251910|144506546|SUPERIORITY|||||||0.0926|||||||Mixed effects model|||Part A-30 mcg BXCL501 V/S Part A-Placebo (Day 1; 30 minutes)||||0.0926
72489241|NCT04251910|144506546|SUPERIORITY|||||||0.3976|||||||Mixed effects model|||Part A-30 mcg BXCL501 V/S Part A-Placebo (Day 1; 1 hour)||||0.3976
72489242|NCT04251910|144506546|SUPERIORITY|||||||0.1169|||||||Mixed effects model|||Part A-30 mcg BXCL501 V/S Part A-Placebo (Day 1; 4 hours)||||0.1169
72489243|NCT04251910|144506546|SUPERIORITY|||||||0.3786|||||||Mixed effects model|||Part A-30 mcg BXCL501 V/S Part A-Placebo (Day 1; 8 hours)||||0.3786
72489244|NCT04251910|144506546|SUPERIORITY|||||||0.564|||||||Mixed effects model|||Part A-30 mcg BXCL501 V/S Part A-Placebo (Day 2; 24hours)||||0.5640
72489245|NCT04251910|144506546|SUPERIORITY|||||||0.602|||||||Mixed effects model|||Part A-30 mcg BXCL501 V/S Part A-Placebo (Day 3)||||0.6020
72489246|NCT04251910|144506546|SUPERIORITY|||||||0.5875|||||||Mixed effects model|||Part A-30 mcg BXCL501 V/S Part A-Placebo (Day 7)||||0.5875
72489247|NCT04251910|144506546|SUPERIORITY|||||||0.1055|||||||Mixed effects model|||Part A-60 mcg BXCL501 V/S Part A-Placebo (Day 1; 30 minutes)||||0.1055
72489248|NCT04251910|144506546|SUPERIORITY|||||||0.0024|||||||Mixed effects model|||Part A-60 mcg BXCL501 V/S Part A-Placebo (Day 1; 1 hour)||||0.0024
72489249|NCT04251910|144506546|SUPERIORITY|||||||0.0016|||||||Mixed effects model|||Part A-60 mcg BXCL501 V/S Part A-Placebo (Day 1; 4 hours)||||0.0016
72489250|NCT04251910|144506546|SUPERIORITY|||||||0.0002|||||||Mixed effects model|||Part A-60 mcg BXCL501 V/S Part A-Placebo (Day 1; 8 hours)||||0.0002
72489251|NCT04251910|144506546|SUPERIORITY|||||||0.2039|||||||Mixed effects model|||Part A-60 mcg BXCL501 V/S Part A-Placebo (Day 2; 24 hours)||||0.2039
72489252|NCT04251910|144506546|SUPERIORITY|||||||0.1948|||||||Mixed effects model|||Part A-60 mcg BXCL501 V/S Part A-Placebo (Day 3)||||0.1948
72489253|NCT04251910|144506546|SUPERIORITY|||||||0.5615|||||||Mixed effects model|||Part A-60 mcg BXCL501 V/S Part A-Placebo (Day 7)||||0.5615
72489254|NCT04251910|144506546|SUPERIORITY|||||||0.8266|||||||Mixed effects model|||Part B-40 mcg-BXCL501 v/s Part B-Placebo (Day 1; 30 minutes)||||0.8266
72489255|NCT04251910|144506546|SUPERIORITY|||||||0.0002|||||||Mixed effects model|||Part B-40 mcg-BXCL501 v/s Part B-Placebo (Day 1; 1 hour)||||0.0002
72489256|NCT04251910|144506546|SUPERIORITY|||||||0.0004|||||||Mixed effects model|||Part B-40 mcg-BXCL501 v/s Part B-Placebo (Day 1; 4 hours)||||0.0004
72489257|NCT04251910|144506546|SUPERIORITY|||||||0.1037|||||||Mixed effects model|||Part B-40 mcg-BXCL501 v/s Part B-Placebo (Day 1; 8 hours)||||0.1037
72489258|NCT04251910|144506546|SUPERIORITY|||||||0.3267|||||||Mixed effects model|||Part B-40 mcg-BXCL501 v/s Part B-Placebo (Day 2; 24 hours)||||0.3267
72489259|NCT04251910|144506546|SUPERIORITY|||||||0.0339|||||||Mixed effects model|||Part B-40 mcg-BXCL501 v/s Part B-Placebo (Day 3)||||0.0339
72489260|NCT04251910|144506546|SUPERIORITY|||||||0.1892|||||||Mixed effects model|||Part B-40 mcg-BXCL501 v/s Part B-Placebo (Day7)||||0.1892
72489261|NCT04251910|144506547|SUPERIORITY|||||||0.3359|||||||Fisher Exact|||Part A-30 mcg BXCL501 V/S Part A-Placebo (2 hours post administration)||||0.3359
72489262|NCT04251910|144506547|SUPERIORITY|||||||0.0004|||||||Fisher Exact|||Part A-60 mcg BXCL501 V/S Part A-Placebo (2 hours post administration)||||0.0004
72489263|NCT04251910|144506547|SUPERIORITY|||||||0.0351|||||||Fisher Exact|||||||0.0351
72489264|NCT04251910|144506548|SUPERIORITY|||||||0.0952|||||||Mixed effects model|||Part A-30 mcg BXCL501 V/S Part A-Placebo (2 hours)||||0.0952
72489265|NCT04251910|144506548|SUPERIORITY|||||||0.8977|||||||Mixed effects model|||Part A-30 mcg BXCL501 V/S Part A-Placebo (Day 2; 24 hours)||||0.8977
72489266|NCT04251910|144506548|SUPERIORITY|||||||0.0002|||||||Mixed effects model|||Part A-60 mcg BXCL501 V/S Part A-Placebo (Day 1; 2 hours)||||0.0002
72489267|NCT04251910|144506548|SUPERIORITY|||||||0.3147|||||||Mixed effects model|||Part A-60 mcg BXCL501 V/S Part A-Placebo (Day 2; 24 hours)||||0.3147
72489268|NCT04251910|144506548|SUPERIORITY||||||<|0.0001|||||||Mixed effects model|||Part B-40 mcg-BXCL501 v/s Part B-Placebo (Day 1; 2 hours)||||<.0001
72489269|NCT04251910|144506548|SUPERIORITY|||||||0.1241|||||||Mixed effects model|||Part B-40 mcg-BXCL501 v/s Part B-Placebo (Day 2; 24 hours)||||0.1241
72404296|NCT00110812|144315215|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.54|||<|0.001|TWO_SIDED|95.0|0.24|0.85|||ANOVA|Stratified by region and adjusted for baseline HIV-RNA||||0.85|0.24|<.001
72404297|NCT00110812|144315218|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.45||||0.59|TWO_SIDED|95.0|0.38|5.45|||Regression, Cox|Stratification by region.|IL-2 group compared to control group|||5.45|0.38|.59
72404298|NCT00110812|144315219|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-55.9|STANDARD_ERROR_OF_MEAN|28.4||0.05||95.0|||||ANOVA|Last measured CD4 is imputed if month 24 CD4 count is missing. Analysis is adjusted for baseline CD4.|IL-2 group minus control group CD4.|||||.05
72404299|NCT00110812|144315221|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.71||||0.03|TWO_SIDED|95.0|0.52|0.97|||Regression, Cox||IL-2 groups vs. control|||.97|.52|.03
72489270|NCT04251910|144506549|SUPERIORITY|||||||0.408|||||||Mixed effects model|||Part A-30 mcg BXCL501 V/S Part A-Placebo (Day 1; 30 minutes)||||0.4080
72489271|NCT04251910|144506549|SUPERIORITY|||||||0.4198|||||||Mixed effects model|||Part A-30 mcg BXCL501 V/S Part A-Placebo (Day 1; 1 hour)||||0.4198
72489272|NCT04251910|144506549|SUPERIORITY|||||||0.037|||||||Mixed effects model|||Part A-30 mcg BXCL501 V/S Part A-Placebo (Day1; 2 hours)||||0.0370
72489273|NCT04251910|144506549|SUPERIORITY|||||||0.1324|||||||Mixed effects model|||Part A-30 mcg BXCL501 V/S Part A-Placebo (Day 1; 4 hours)||||0.1324
72489274|NCT04251910|144506549|SUPERIORITY|||||||0.0624|||||||Mixed effects model|||Part A-30 mcg BXCL501 V/S Part A-Placebo (Day 1; 8 hours)||||0.0624
72489275|NCT04251910|144506549|SUPERIORITY|||||||0.6334|||||||Mixed effects model|||Part A-60 mcg BXCL501 V/S Part A-Placebo (Day 1; 30 minutes)||||0.6334
72516169|NCT01231607|144563344|NON_INFERIORITY_OR_EQUIVALENCE|Differences between dutasteride (DUT) and finasteride (FIN) were assessed using a general linear model (GLM) adjusted for treatment, cluster, and BL hair count (HC). The one-sided 99.165% confidence interval (CI) for DUT minus FIN was derived, and noninferiority (NI) demonstrated if the lower end of the CI was greater than -35 hairs. If NI was achieved with a dose of DUT, the primary endpoint was to be analyzed for superiority against FIN using a GLM adjusted for treatment, cluster, and BL HC.|Least squares mean difference|6.5||||0.28||99.165|-20.1|33.1|||General linear model||Estimates are based on the adjusted (least-squares) means from the general linear model: Change from Baseline = Treatment + Cluster + Baseline Value. The estimation value represents the finasteride 1 mg LS mean minus the Dutasteride 0.1 mg LS mean.|||33.1|-20.1|0.28
72516170|NCT01231607|144563344|NON_INFERIORITY_OR_EQUIVALENCE|Differences between dutasteride (DUT) and finasteride (FIN) were assessed using a general linear model (GLM) adjusted for treatment, cluster, and BL hair count (HC). The one-sided 99.165% confidence interval (CI) for DUT minus FIN was derived, and noninferiority (NI) demonstrated if the lower end of the CI was greater than -35 hairs. If NI was achieved with a dose of DUT, the primary endpoint was to be analyzed for superiority against FIN using a GLM adjusted for treatment, cluster, and BL HC.|Least squares mean difference|33.0||||0.002||99.165|6.1|60.0|||General linear model||Estimates are based on the adjusted (least-squares) means from the general linear model: Change from Baseline = Treatment + Cluster + Baseline Value. The estimation value represents the finasteride 1 mg LS mean minus the Dutasteride 0.5 mg LS mean.|||60|6.1|0.002
72568573|NCT04168190|144668501|OTHER|Geometric mean concentration (GMC) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMC Ratio|2.08|||||TWO_SIDED|95.0|1.19|3.63|||||Phase 1: V116 1.0 mL/Phase 1: Pneumovax™23|Serotype 19A||3.63|1.19|
72404300|NCT03865329|144315226|SUPERIORITY|||||||0.13|||||||t-test, 2 sided|||||||0.13
72404301|NCT03865329|144315227|SUPERIORITY|||||||0.01|||||||t-test, 2 sided|||||||0.01
72404302|NCT03865329|144315229|SUPERIORITY|||||||0.1|||||||t-test, 2 sided|||||||0.10
72404303|NCT03865329|144315230|SUPERIORITY|||||||0.25|||||||t-test, 2 sided|||||||0.25
72404304|NCT00526058|144315232|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority of the Futura system to the Secura system would be demonstrated if the upper bound of the 90% confidence interval (CI) for the difference between the two systems (Secura-Futura) in percent change of LDL-C measurements from pre- to post-treatment is less than the noninferiority margin 5.7%.||||||0.005|TWO_SIDED|90.0|||||ANOVA|||||||0.005
72404305|NCT03917420|144315277|OTHER|Correlation|Spearman's Rho|-0.455|||||TWO_SIDED|||||||||||||
72404306|NCT03917420|144315278|OTHER|Correlation|Spearman's Rho|0.152|||||TWO_SIDED|||||||||||||
72489276|NCT04251910|144506549|SUPERIORITY|||||||0.0275|||||||Mixed effects model|||Part A-60 mcg BXCL501 V/S Part A-Placebo (Day 1; 1 hour)||||0.0275
72489277|NCT04251910|144506549|SUPERIORITY||||||<|0.0001|||||||Mixed effects model|||Part A-60 mcg BXCL501 V/S Part A-Placebo (Day 1; 2 hours)||||<.0001
72489278|NCT04251910|144506549|SUPERIORITY|||||||0.0001|||||||Mixed effects model|||Part A-60 mcg BXCL501 V/S Part A-Placebo (Day 1; 4 hours)||||0.0001
72489279|NCT04251910|144506549|SUPERIORITY||||||<|0.0001|||||||Mixed effects model|||Part A-60 mcg BXCL501 V/S Part A-Placebo (Day1; 8 hours)||||<.0001
72489280|NCT04251910|144506549|SUPERIORITY|||||||0.2806|||||||Mixed effects model|||Part B-40 mcg-BXCL501 v/s Part B-Placebo (Day 1; 30 minutes)||||0.2806
72489281|NCT04251910|144506549|SUPERIORITY|||||||0.0002|||||||Mixed effects model|||Part B-40 mcg-BXCL501 v/s Part B-Placebo (Day 1; 1 hour)||||0.0002
72489282|NCT04251910|144506549|SUPERIORITY||||||<|0.0001|||||||Mixed effects model|||Part B-40 mcg-BXCL501 v/s Part B-Placebo (Day 1; 2 hour)||||<.0001
72489283|NCT04251910|144506549|SUPERIORITY|||||||0.0009|||||||Mixed effects model|||Part B-40 mcg-BXCL501 v/s Part B-Placebo (Day 1; 4 hours)||||0.0009
72489284|NCT04251910|144506549|SUPERIORITY|||||||0.0081|||||||Mixed effects model|||Part B-40 mcg-BXCL501 v/s Part B-Placebo (Day 1; 8 hours)||||0.0081
72489285|NCT04251910|144506550|SUPERIORITY|||||||0.0591|||||||Mixed effects model|||Part A-30 mcg BXCL501 V/S Part A-Placebo (Day 1; 2 hours)||||0.0591
72489286|NCT04251910|144506550|SUPERIORITY|||||||0.0966|||||||Mixed effects model|||Part A-30 mcg BXCL501 V/S Part A-Placebo (Day 7)||||0.0966
72489287|NCT04251910|144506550|SUPERIORITY||||||<|0.0001|||||||Mixed effects model|||Part A-60 mcg BXCL501 V/S Part A-Placebo (Day 1; 2 hours)||||<.0001
72489288|NCT04251910|144506550|SUPERIORITY|||||||0.029|||||||Mixed effects model|||Part A-60 mcg BXCL501 V/S Part A-Placebo (Day 7)||||0.0290
72489289|NCT04251910|144506550|SUPERIORITY|||||||0.0937|||||||Mixed effects model|||Part B-40 mcg-BXCL501 v/s Part B-Placebo (Day 1; 2 hours)||||0.0937
72489290|NCT04251910|144506550|SUPERIORITY|||||||0.2747|||||||Mixed effects model|||Part B-40 mcg-BXCL501 v/s Part B-Placebo (Day 7)||||0.2747
72489291|NCT04251910|144506553|SUPERIORITY|||||||0.0002|||||||Mixed effects model|||Part B-40 mcg-BXCL501 v/s Part B-Placebo (2 hours post administration)||||0.0002
72489292|NCT00804570|144506556|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.3||||0.12|TWO_SIDED|95.0|-9.72|1.13|||Mixed Models Analysis|||||1.13|-9.72|0.120
72489293|NCT00804570|144506557|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.71||||0.013|TWO_SIDED|95.0|-1.27|-0.15|||Mixed Models Analysis|||||-0.15|-1.27|0.013
72489294|NCT00804570|144506558|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.37||||0.051|TWO_SIDED|95.0|-0.02|10.77|||Mixed Models Analysis|||||10.77|-0.02|0.051
72489295|NCT00804570|144506559|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.4||||0.249|TWO_SIDED|95.0|-1.07|0.28|||Mixed Models Analysis|||||0.28|-1.07|0.249
72489296|NCT00804570|144506560|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.44||||0.199|TWO_SIDED|95.0|-1.12|0.23|||Mixed Models Analysis|||||0.23|-1.12|0.199
72404307|NCT03917420|144315279|OTHER|Correlation|Spearman's Rho|0.564|||||TWO_SIDED|||||||||||||
72404308|NCT03917420|144315280|OTHER|Correlation|Spearman's Rho|0.285|||||TWO_SIDED|||||||||||||
72489297|NCT00804570|144506561|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.68||||0.318|TWO_SIDED|95.0|-2.03|0.66|||Mixed Models Analysis|||||0.66|-2.03|0.318
72489298|NCT00804570|144506562|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.01||||0.034|TWO_SIDED|95.0|-5.8|-0.22|||Mixed Models Analysis|||||-0.22|-5.80|0.034
72489299|NCT00804570|144506563|SUPERIORITY_OR_OTHER_LEGACY||GMR over Baseline relative to placebo|0.9||||0.001|TWO_SIDED|95.0|0.85|0.96|||Mixed Models Analysis|||||0.96|0.85|0.001
72489300|NCT00804570|144506564|SUPERIORITY_OR_OTHER_LEGACY||GMR over Baseline relative to placebo|0.96||||0.103|TWO_SIDED|95.0|0.91|1.01|||Mixed Models Analysis|||||1.01|0.91|0.103
72489301|NCT00804570|144506565|SUPERIORITY_OR_OTHER_LEGACY||GMR over Baseline relative to placebo|0.94||||0.012|TWO_SIDED|95.0|0.89|0.99|||Mixed Models Analysis|||||0.99|0.89|0.012
72516171|NCT01231607|144563344|SUPERIORITY_OR_OTHER||Least squares mean difference|-39.4|||<|0.001|TWO_SIDED|98.33|-66.1|-12.7|||General linear model||Estimates are based on the adjusted (least-squares) means from the general linear model: Change from Baseline = Treatment + Cluster + Baseline Value. The estimation value represents the finasteride 1 mg LS mean minus the Dutasteride 0.02 mg LS mean.|||-12.7|-66.1|<0.001
72404309|NCT03712410|144315306|OTHER|Group Comparisons||||||0.186||||||p-value for Difference (FollowUp-Baseline) Generalised Anxiety Disorder Assessment (GAD-7)|Kruskal-Wallis|||||||0.1860
72568574|NCT04168190|144668501|OTHER|Geometric mean concentration (GMC) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMC Ratio|0.74|||||TWO_SIDED|95.0|0.37|1.46|||||Phase 1: V116 0.5 mL/Phase 1: Pneumovax™23|Serotype 22F||1.46|0.37|
72404310|NCT03712410|144315306|OTHER|Group Comparisons||||||0.2752||||||p-value for Difference (FollowUp-Baseline) Patient Health Questionnaire 9 (PHQ9)|Kruskal-Wallis|||||||0.2752
72404311|NCT03712410|144315306|OTHER|Group Comparisons||||||0.6233||||||p-value for Difference (FollowUp-Baseline) Caregiver Quality of Life Index (CQLI-R)|Kruskal-Wallis|||||||0.6233
72404312|NCT03712410|144315307|OTHER|Group Comparison||||||0.5638||||||p-value for Difference (FollowUp-Baseline) Generalised Anxiety Disorder Assessment (GAD-7)|Wilcoxon (Mann-Whitney)|||||||0.5638
72404313|NCT03712410|144315307|OTHER|Group Comparisons||||||0.9848||||||p-value for Difference (FollowUp-Baseline) Patient Health Questionnaire 9 (PHQ9)|Wilcoxon (Mann-Whitney)|||||||0.9848
72489302|NCT00804570|144506566|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.32||||0.392|TWO_SIDED|95.0|-1.05|0.41|||Mixed Models Analysis|||||0.41|-1.05|0.392
72489303|NCT00804570|144506567|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.44||||0.185|TWO_SIDED|95.0|-1.1|0.21|||Mixed Models Analysis|||||0.21|-1.10|0.185
72489304|NCT00804570|144506568|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.25||||0.142|TWO_SIDED|95.0|-0.42|2.92|||ANCOVA|||||2.92|-0.42|0.142
72489305|NCT00804570|144506569|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.48||||0.69|TWO_SIDED|95.0|-1.01|0.04||P-value is for desire to stop drinking at this time.|ANCOVA|||||0.04|-1.01|0.69
72489306|NCT00804570|144506569|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.2||||0.545|TWO_SIDED|95.0|-0.85|0.45||P-value is for expectation of success in quitting alcohol.|ANCOVA|||||0.45|-0.85|0.545
72489307|NCT00804570|144506569|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.48||||0.19|TWO_SIDED|95.0|-1.2|0.24||P-value is for difficulty to quit and remain abstinent.|ANCOVA|||||0.24|-1.20|0.190
72489308|NCT00804570|144506569|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.04||||0.856|TWO_SIDED|95.0|-0.49|0.4||P-value is for goal related to alcohol use.|ANCOVA|||||0.40|-0.49|0.856
72489309|NCT00804570|144506570|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.77||||0.297|TWO_SIDED|95.0|-0.68|2.22|||Mixed Models Analysis|||||2.22|-0.68|0.297
72489310|NCT00804570|144506571|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.46||||0.633|TWO_SIDED|95.0|-1.44|2.36|||Mixed Models Analysis|||||2.36|-1.44|0.633
72489311|NCT00804570|144506574|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.77||||0.409|TWO_SIDED|95.0|-2.62|1.07||P-value is for supine systolic blood pressure.|Mixed Models Analysis|||||1.07|-2.62|0.409
72489312|NCT00804570|144506574|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.45||||0.452|TWO_SIDED|95.0|-1.63|0.73||P-value is for supine diastolic blood pressure.|Mixed Models Analysis|||||0.73|-1.63|0.452
72489313|NCT00804570|144506575|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.53||||0.456|TWO_SIDED|95.0|-1.93|0.87|||Mixed Models Analysis|||||0.87|-1.93|0.456
72489314|NCT00804570|144506576|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.08||||0.081|TWO_SIDED|95.0|-4.41|0.26|||Mixed Models Analysis|||||0.26|-4.41|0.081
72489315|NCT00804570|144506577|SUPERIORITY_OR_OTHER_LEGACY|||||||0.122||95.0|||||Fisher Exact|||||||0.122
72489316|NCT00804570|144506578|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002||95.0|||||Fisher Exact|||||||0.002
72489317|NCT00804570|144506579|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.69||||0.235|TWO_SIDED|95.0|-1.82|0.45||P-value is for orthostatic systolic blood pressure.|Mixed Models Analysis|||||0.45|-1.82|0.235
72489318|NCT00804570|144506579|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.31||||0.4|TWO_SIDED|95.0|-1.05|0.42||P-value is for orthostatic diastolic blood pressure.|Mixed Models Analysis|||||0.42|-1.05|0.400
72489319|NCT00804570|144506580|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.74||||0.077|TWO_SIDED|95.0|-0.08|1.57|||Mixed Models Analysis|||||1.57|-0.08|0.077
72489320|NCT00804570|144506582|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.57|||<|0.001|TWO_SIDED|95.0|0.24|0.9|||Mixed Models Analysis|||||0.90|0.24|<0.001
72489321|NCT00290342|144506583|NON_INFERIORITY_OR_EQUIVALENCE|To assess the non-inferiority of the Infanrix-IPV Group compared to the Infanrix + IMOVAX Polio Group in terms of vaccine response to diphtheria, standardized asymptotic 95% CI for the groups'difference (Infanrix-IPV Group minus Infanrix + IMOVAX Polio Group) was computed. Objective of non-inferiority was met since the LL of the 95% CI was above -10%.|Difference in seroprotection rate|0.0|||||TWO_SIDED|95.0|-1.85|1.79||||||Non-inferiority in terms of vaccine response to diphteria||1.79|-1.85|
72489322|NCT00290342|144506583|NON_INFERIORITY_OR_EQUIVALENCE|To assess the non-inferiority of the Infanrix-IPV Group compared to the Infanrix + IMOVAX Polio Group in terms of vaccine response to tetanus, standardized asymptotic 95% CI for the groups'difference (Infanrix-IPV Group minus Infanrix + IMOVAX Polio Group) was computed. Objective of non-inferiority was met since the LL of the 95% CI was above -10%.|Difference in seroprotection rate|0.0|||||TWO_SIDED|95.0|-1.85|1.79||||||Non-inferiority in terms of vaccine response to tetanus||1.79|-1.85|
72489323|NCT00290342|144506584|NON_INFERIORITY_OR_EQUIVALENCE|To assess the non-inferiority of the Infanrix-IPV Group compared to the Infanrix + IMOVAX Polio Group in terms of vaccine response to poliovirus type 1, standardized asymptotic 95% CI for the groups' difference (Infanrix-IPV Group minus Infanrix + IMOVAX Polio Group) was computed. Objective of non-inferiority was met since the LL of the 95% CI was above -10%.|Difference in seroprotection rate|0.0|||||TWO_SIDED|95.0|-1.85|1.82||||||Immune response non-inferiority - Anti-Polio 1||1.82|-1.85|
72489324|NCT00290342|144506584|NON_INFERIORITY_OR_EQUIVALENCE|To assess the non-inferiority of the Infanrix-IPV Group compared to the Infanrix + IMOVAX Polio Group in terms of vaccine response to poliovirus type 2, standardized asymptotic 95% CI for the groups' difference (Infanrix-IPV Group minus Infanrix + IMOVAX Polio Group) was computed. Objective of non-inferiority was met since the LL of the 95% CI was above -10%.|Difference in seroprotection rate|0.49|||||TWO_SIDED|95.0|-1.36|2.71||||||Immune response non-inferiority - Anti-Polio 2||2.71|-1.36|
72489325|NCT00290342|144506584|NON_INFERIORITY_OR_EQUIVALENCE|To assess the non-inferiority of the Infanrix-IPV Group compared to the Infanrix + IMOVAX Polio Group in terms of vaccine response to poliovirus type 3, standardized asymptotic 95% CI for the groups' difference (Infanrix-IPV Group minus Infanrix + IMOVAX Polio Group) was computed. Objective of non-inferiority was met since the LL of the 95% CI was above -10%.|Difference in seroprotection rate|-0.01|||||TWO_SIDED|95.0|-2.28|2.24||||||Immune response non-inferiority - Anti-Polio 3||2.24|-2.28|
72489326|NCT00290342|144506585|NON_INFERIORITY_OR_EQUIVALENCE|To assess the non-inferiority of the Infanrix-IPV Group compared to the Infanrix + IMOVAX Polio Group in terms of vaccine response to pertussis toxoid, standardized asymptotic 95% CI for the groups' difference (Infanrix-IPV Group minus Infanrix + IMOVAX Polio Group) was computed. Objective of non-inferiority was met since the LL of the 95% CI was above -10%.|Difference in seroprotection rate|1.44|||||TWO_SIDED|95.0|-0.46|4.13||||||Immune response non-inferiority - Anti-PT||4.13|-0.46|
72489327|NCT00290342|144506585|NON_INFERIORITY_OR_EQUIVALENCE|To assess the non-inferiority of the Infanrix-IPV Group compared to the Infanrix + IMOVAX Polio Group in terms of vaccine response to filamentous haemagglutinin, standardized asymptotic 95% CI for the groups' difference (Infanrix-IPV Group minus Infanrix + IMOVAX Polio Group) was computed. Objective of non-inferiority was met since the LL of the 95% CI was above -10%.|Difference in seroprotection rate|0.45|||||TWO_SIDED|95.0|-1.88|2.95||||||Immune response non-inferiority - Anti-FHA||2.95|-1.88|
72489328|NCT00290342|144506585|NON_INFERIORITY_OR_EQUIVALENCE|To assess the non-inferiority of the Infanrix-IPV Group compared to the Infanrix + IMOVAX Polio Group in terms of vaccine response to pertactin, standardized asymptotic 95% CI for the groups' difference (Infanrix-IPV Group minus Infanrix + IMOVAX Polio Group) was computed. Objective of non-inferiority was met since the LL of the 95% CI was above -10%.|Difference in seroprotection rate|0.47|||||TWO_SIDED|95.0|-1.4|2.64||||||Immune response non-inferiority - Anti-PRN||2.64|-1.4|
72404314|NCT03712410|144315307|OTHER|Group Comparisons||||||0.9169||||||p-value for Difference (FollowUp-Baseline) Caregiver Quality of Life Index (CQLI-R)|Wilcoxon (Mann-Whitney)|||||||0.9169
72489329|NCT01056510|144506596|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED|||||Based on one-sided continuity corrected Chi-Square Test for participants achieving CR confirmed with biopsy versus those not achieving CR confirmed with biopsy|Chi-squared, Corrected|||The first-line subpopulation became the focus of the primary statistical analysis following the protocol amendment dated 21-May-2012.||||0.002
72489330|NCT01056510|144506597|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Based on one-sided continuity corrected Chi-Square Test for participants achieving CR confirmed with biopsy versus those not achieving CR confirmed with biopsy|Chi-squared, Corrected|||||||< 0.001
72489331|NCT01056510|144506598|SUPERIORITY_OR_OTHER|||||||0.009|TWO_SIDED|||||Based on one-sided continuity corrected Chi-Square Test for participants achieving CR confirmed with biopsy versus those not achieving CR confirmed with biopsy|Chi-squared, Corrected|||||||0.009
72516172|NCT01231607|144563344|SUPERIORITY_OR_OTHER||Least squares mean difference|6.5||||0.56|TWO_SIDED|98.33|-20.1|33.1|||General linear model||Estimates are based on the adjusted (least-squares) means from the general linear model: Change from Baseline = Treatment + Cluster + Baseline Value. The estimation value represents the finasteride 1 mg LS mean minus the Dutasteride 0.1 mg LS mean.|||33.1|-20.1|0.56
72568575|NCT04168190|144668501|OTHER|Geometric mean concentration (GMC) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMC Ratio|1.0|||||TWO_SIDED|95.0|0.5|2.0|||||Phase 1: V116 1.0 mL/Phase 1: Pneumovax™23|Serotype 22F||2.00|0.50|
72489332|NCT01056510|144506599|SUPERIORITY_OR_OTHER|||||||0.9|TWO_SIDED|||||Based on two-sided continuity corrected Chi-Square Test|Chi-squared, Corrected|||After 3 cycles||||0.900
72489333|NCT01056510|144506599|SUPERIORITY_OR_OTHER|||||||0.563|TWO_SIDED|||||Based on two-sided continuity corrected Chi-Square Test|Chi-squared, Corrected|||After 6 cycles||||0.563
72489334|NCT01056510|144506599|SUPERIORITY_OR_OTHER|||||||0.304|TWO_SIDED|||||Based on two-sided continuity corrected Chi-Square Test|Chi-squared, Corrected|||At the EOT visit||||0.304
72489335|NCT01056510|144506602|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.525||||0.003|TWO_SIDED|95.0|0.341|0.809|||Log Rank|||Unstratified analysis||0.809|0.341|0.003
72489336|NCT01056510|144506602|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.523||||0.003|TWO_SIDED|95.0|0.339|0.806|||Log Rank|||Stratified analysis: by baseline Binet stage||0.806|0.339|0.003
72489337|NCT01056510|144506604|SUPERIORITY_OR_OTHER|||||||0.029|TWO_SIDED||||||Log Rank|||||||0.029
72489338|NCT01056510|144506606|SUPERIORITY_OR_OTHER|||||||0.006|TWO_SIDED||||||Log Rank|||||||0.006
72489339|NCT01056510|144506608|SUPERIORITY_OR_OTHER|||||||0.037|TWO_SIDED||||||Log Rank|||||||0.037
72489340|NCT01056510|144506610|SUPERIORITY_OR_OTHER|||||||0.007|TWO_SIDED||||||Log Rank|||||||0.007
72489341|NCT01056510|144506612|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.994||||0.986|TWO_SIDED|95.0|0.517|1.911||Unstratified analysis|Log Rank|||||1.911|0.517|0.986
72489342|NCT01056510|144506612|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.975||||0.939|TWO_SIDED|95.0|0.505|1.88|||Log Rank|||Stratified analysis: by baseline Binet stage||1.880|0.505|0.939
72489343|NCT01056510|144506613|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Based on two-sided continuity corrected Chi-Square Test|Chi-squared, Corrected|||||||< 0.001
72489344|NCT00243386|144506616|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6016||95.0|||||t-test, 2 sided|||A t-test was used to compare the means of the transformed data. The null-hypothesis tested was H0: X'A(PK-driven prophylaxis) - X'B (standard prophylaxis) = 0 (i.e., no difference for treatment under the 2 prophylactic regimens. X' = (ABR+0.5)\^(1/2)||||0.6016
72489345|NCT00243386|144506617|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0||||2-sided paired T-tests were done comparing transformed annualized bleeding rates between On-Demand and Prophylaxis regimens.|Paired t-Test|||||||<0.0001
72489346|NCT00243386|144506618|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0||||2-sided paired T-tests were done comparing transformed annualized bleeding rates between On-Demand and Prophylaxis regimens.|Paired t-test|||||||<0.0001
72489347|NCT00243386|144506619|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0||||2-sided paired T-tests were done comparing transformed annualized bleeding rates between On-Demand and Prophylaxis regimens.|Paired t-test|||||||<0.0001
72489348|NCT00243386|144506620|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4924||95.0|||||Wilcoxon-Rank Sum (Mann-Whitney)|||||||0.4924
72489349|NCT00243386|144506641|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1467||95.0|||||Wilcoxon-Rank Sum (Mann-Whitney)|||||||0.1467
72404315|NCT03712410|144315308|OTHER|Group Comparisons|||||<|0.0001||||||p-value for Generalised Anxiety Disorder Assessment (GAD-7) for arm Traditional PISCES|Wilcoxon Signed Rank Test|||||||<0.0001
72489350|NCT00243386|144506642|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0007||95.0||||Due to multiple hypotheses testing results, adjusted alpha values are set to α\*=0.005 (0.05/10). Adjustments take into account 10 hypotheses tests between On-Demand and any Prophylaxis. Statistically significant results are considered p-values \< α\*|Wilcoxon signed-rank test|||||||0.0007
72404316|NCT03712410|144315308|OTHER|Group Comparisons|||||<|0.0001||||||p-value for Patient Health Questionnaire 9 (PHQ9) for arm Traditional PISCES|Wilcoxon Signed Rank Test|||||||<0.0001
72489351|NCT00243386|144506643|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0002||95.0||||Due to multiple hypotheses testing results, adjusted alpha values are set to α\*=0.005 (0.05/10). Adjustments take into account 10 hypotheses tests between On-Demand and any Prophylaxis. Statistically significant results are considered p-values \< α\*|Wilcoxon signed-rank test|||||||0.0002
72489352|NCT00243386|144506644|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||Wilcoxon Signed-Rank Test|||||||<0.0001
72489353|NCT03002155|144506650|SUPERIORITY|||||||0.26||||||Not adjusted for multiple comparisons due to the pilot nature of the study, alpha level was 0.10.|ANOVA|||||||.26
72489354|NCT03002155|144506651|SUPERIORITY|||||||0.38|||||||ANOVA|||||||0.38
72489355|NCT03002155|144506652|SUPERIORITY|||||||0.24|||||||ANOVA|||For PROMIS Global Physical||||0.24
72489356|NCT03002155|144506652|SUPERIORITY|||||||0.8||||||p-value is interaction of group and time. Alpha level= 0.10; not adjusted for multiple comparisons (pilot study)|ANOVA|||For PROMIS Global Mental||||0.80
72489357|NCT03002155|144506653|SUPERIORITY|||||||0.81||||||p-value is interaction of group and time. Alpha level= 0.10; not adjusted for multiple comparisons (pilot study)|ANOVA|||||||0.81
72489358|NCT03002155|144506654|SUPERIORITY|||||||0.03||||||p-value is interaction of group and time. Alpha level= 0.10; not adjusted for multiple comparisons (pilot study)|ANOVA|||||||0.03
72489359|NCT00978029|144506662|SUPERIORITY_OR_OTHER||Percent Difference|6.9||||0.486|TWO_SIDED|95.0|-10.17|23.97|||Fisher Exact|||||23.97|-10.17|0.486
72489360|NCT00978029|144506662|SUPERIORITY_OR_OTHER||Percent Difference|16.9||||0.078|TWO_SIDED|95.0|0.01|33.83|||Fisher Exact|||||33.83|0.01|0.078
72489361|NCT01553188|144506677|SUPERIORITY|||||||0.44|||||||Log rank two-tailed p-value|||||||0.44
72489362|NCT01553188|144506679|SUPERIORITY|||||||0.26|||||||Log rank two-tailed p-value|||||||0.26
72489363|NCT04744207|144506694|SUPERIORITY||Least squares mean estimate|0.81|||<|0.05|TWO_SIDED|95.0|-2.48|4.1|||ANCOVA|||||4.10|-2.48|<0.05
72489364|NCT02958007|144506715|SUPERIORITY|||||||0.544|||||||t-test, 2 sided|||||||0.544
72489365|NCT00495820|144506716|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Mixed Models Analysis|||||||<0.05
72489366|NCT00495820|144506717|SUPERIORITY_OR_OTHER||||||=|0.01|||||||Mixed Models Analysis|||||||=0.01
72489367|NCT02186847|144506730|SUPERIORITY||Hazard Ratio (HR)|1.15||||0.7563|TWO_SIDED|95.0|0.77|1.73|||Log Rank|One-sided significance level = 0.10|Reference level = Chemoradiation|The study was powered to detect an improvement of the 1-year progression-free survival rate from 50% (no metformin) to 65% (metformin) or equivalently a hazard ratio (HR) of 0.622, at one-sided type 1 error of 0.1 and 85% power with at least 102 progression-free survival events.||1.73|0.77|0.7563
72489368|NCT02186847|144506731|SUPERIORITY||Hazard Ratio (HR)|1.03||||0.891|TWO_SIDED|95.0|0.64|1.68|||Log Rank|Two-sided significance level = 0.05|Reference level = Chemoradiation|||1.68|0.64|0.8910
72489369|NCT02186847|144506732|SUPERIORITY||Hazard Ratio (HR)|1.29||||0.4075|TWO_SIDED|95.0|0.71|2.34|||Log Rank|Two-side significance level = 0.05|Reference level = Chemoradiation|||2.34|0.71|0.4075
72489370|NCT02186847|144506733|SUPERIORITY||Hazard Ratio (HR)|1.29||||0.4075|TWO_SIDED|95.0|0.71|2.34|||Log Rank|Two-sided significance level = 0.05|Reference level = Chemoradiation|||2.34|0.71|0.4075
72489371|NCT02186847|144506734|SUPERIORITY||Odds Ratio (OR)|0.92||||0.6266|TWO_SIDED|95.0|0.47|1.8|||Chi-squared|Two-sided significance level = 0.05|Reference level = Chemoradiation|||1.80|0.47|0.6266
72489372|NCT04342871|144506748|OTHER|Pre-post comparison from baseline to 2-weeks post-intervention||||||0.2|||||||t-test, 2 sided|||||||0.2
72489373|NCT00666458|144506752|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.09|STANDARD_ERROR_OF_MEAN|0.055|||TWO_SIDED|95.0|-0.01|0.2||||||||0.20|-0.01|
72489374|NCT00666458|144506753|SUPERIORITY_OR_OTHER||Difference in Percent|-2.8|||||TWO_SIDED|95.0|-9.0|3.5||||||||3.5|-9.0|
72489375|NCT00666458|144506754|SUPERIORITY_OR_OTHER||Mean Difference (Net)|5.42|STANDARD_ERROR_OF_MEAN|2.064|||TWO_SIDED|95.0|1.37|9.47||||||||9.47|1.37|
72489376|NCT00666458|144506755|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.3|STANDARD_ERROR_OF_MEAN|0.115|||TWO_SIDED|95.0|0.08|0.53||||||||0.53|0.08|
72489377|NCT01999465|144506816|OTHER|||||||0.4|||||||Wilcoxon (Mann-Whitney)|We applied Wilcoxon-Mann Whitney test with the Null hypothesis that there is no difference between 2 arms.||||||0.40
72489378|NCT01999465|144506817|OTHER|||||||0.2|||||||t-test, 2 sided|||||||0.20
72489379|NCT00880399|144506848|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.47||||0.4295|TWO_SIDED|95.0|-1.65|0.7|||Mixed Models Repeated Measures|||Placebo Vs Orvepitatnt 30 mg at Week 1||0.70|-1.65|0.4295
72489380|NCT00880399|144506848|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.15||||0.0586|TWO_SIDED|95.0|-2.34|0.04|||Mixed Models Repeated Measures|||Placebo Vs Orvepitatnt 60 mg at Week 1||0.04|-2.34|0.0586
72489381|NCT00880399|144506848|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.89||||0.0111|TWO_SIDED|95.0|-3.34|-0.43|||Mixed Models Repeated Measures|||Placebo Vs Orvepitatnt 30 mg at Week 2||-0.43|-3.34|0.0111
72489382|NCT00880399|144506848|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.84||||0.0141|TWO_SIDED|95.0|-3.3|-0.37|||Mixed Models Repeated Measures|||Placebo Vs Orvepitatnt 60 mg at Week 2||-0.37|-3.30|0.0141
72489383|NCT00880399|144506848|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.22||||0.0152|TWO_SIDED|95.0|-4.0|-0.43|||Mixed Models Repeated Measures|||Placebo Vs Orvepitatnt 30 mg at Week 4||-0.43|-4.00|0.0152
72489384|NCT00880399|144506848|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.06||||0.001|TWO_SIDED|95.0|-4.86|-1.25|||Mixed Models Repeated Measures|||Placebo Vs Orvepitatnt 60 mg at Week 4||-1.25|-4.86|0.0010
72489385|NCT00880399|144506848|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.41||||0.0245|TWO_SIDED|95.0|-4.5|-0.31|||Mixed Models Repeated Measures|||Placebo Vs Orvepitatnt 30 mg at Week 6||-0.31|-4.50|0.0245
72489386|NCT00880399|144506848|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.86||||0.0082|TWO_SIDED|95.0|-4.97|-0.75|||Mixed Models Repeated Measures|||Placebo Vs Orvepitatnt 60 mg at Week 6||-0.75|-4.97|0.0082
72489387|NCT00880399|144506850|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.6||||0.51|TWO_SIDED|95.0|0.8|3.19|||Log Rank|||Placebo Vs Orvepitant 30 mg at Week 6||3.19|0.80|0.51
72516173|NCT01231607|144563344|SUPERIORITY_OR_OTHER||Least squares mean difference|33.0||||0.003|TWO_SIDED|98.33|6.1|60.0|||General linear model||Estimates are based on the adjusted (least-squares) means from the general linear model: Change from Baseline = Treatment + Cluster + Baseline Value. The estimation value represents the finasteride 1 mg LS mean minus the Dutasteride 0.5 mg LS mean.|||60|6.1|0.003
72516174|NCT02513771|144563389|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|Stratified Wilcoxon rank-sum test stratified by screening CD4 count (\<= or \> 350 cells/mm\^3) and statin use.||Null hypothesis: There is no difference between the two arms in the change in sCD14 from baseline to week 15/16.||||1.000
72489388|NCT00880399|144506850|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.66||||0.37|TWO_SIDED|95.0|0.84|3.3|||Log Rank|||Placebo Vs Orvepitant 60 mg at Week 6||3.30|0.84|0.37
72489389|NCT00880399|144506851|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.09||||0.7859|TWO_SIDED|95.0|-0.72|0.55|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg at Week 1||0.55|-0.72|0.7859
72489390|NCT00880399|144506851|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.15||||0.6429|TWO_SIDED|95.0|-0.79|0.49|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg at Week 1||0.49|-0.79|0.6429
72489391|NCT00880399|144506851|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.04||||0.0092|TWO_SIDED|95.0|-1.82|-0.26|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg at Week 2||-0.26|-1.82|0.0092
72489392|NCT00880399|144506851|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.91||||0.023|TWO_SIDED|95.0|-1.69|-0.13|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg at Week 2||-0.13|-1.69|0.0230
72489393|NCT00880399|144506851|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.29||||0.0104|TWO_SIDED|95.0|-2.27|-0.31|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg at Week 4||-0.31|-2.27|0.0104
72489394|NCT00880399|144506851|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.68||||0.001|TWO_SIDED|95.0|-2.67|-0.69|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg at Week 4||-0.69|-2.67|0.0010
72489395|NCT00880399|144506851|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.22||||0.0361|TWO_SIDED|95.0|-2.37|-0.08|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg at Week 6||-0.08|-2.37|0.0361
72489396|NCT00880399|144506851|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.54||||0.0092||95.0|-2.69|-0.38|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg at Week 6||-0.38|-2.69|0.0092
72489397|NCT00880399|144506852|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.72||||0.1662|TWO_SIDED|95.0|-1.74|0.3|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg at Week 1||0.30|-1.74|0.1662
72489398|NCT00880399|144506852|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.66||||0.2116|TWO_SIDED|95.0|-1.69|0.38|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg at Week 1||0.38|-1.69|0.2116
72489399|NCT00880399|144506852|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.02||||0.082|TWO_SIDED|95.0|-2.17|0.13|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg at Week 2||0.13|-2.17|0.0820
72489400|NCT00880399|144506852|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.55||||0.3498|TWO_SIDED|95.0|-1.71|0.61|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg at Week 2||0.61|-1.71|0.3498
72489401|NCT00880399|144506852|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.69||||0.0107|TWO_SIDED|95.0|-2.99|-0.4|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg at Week 4||-0.40|-2.99|0.0107
72489402|NCT00880399|144506852|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.1||||0.0017|TWO_SIDED|95.0|-3.4|-0.79|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg at Week 4||-0.79|-3.40|0.0017
72489403|NCT00880399|144506852|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.29||||0.088|TWO_SIDED|95.0|-2.78|0.19|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg at Week 6||0.19|-2.78|0.0880
72489404|NCT00880399|144506852|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.68||||0.0282|TWO_SIDED|95.0|-3.17|-0.18|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg at Week 6||-0.18|-3.17|0.0282
72489405|NCT00880399|144506853|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0||||0.9854|TWO_SIDED|95.0|-0.45|0.44|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg at Week 1||0.44|-0.45|0.9854
72489406|NCT00880399|144506853|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.21||||0.3476|TWO_SIDED|95.0|-0.66|0.23|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg at Week 1||0.23|-0.66|0.3476
72489407|NCT00880399|144506853|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.44||||0.0898|TWO_SIDED|95.0|-0.94|0.07|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg at Week 2||0.07|-0.94|0.0898
72489408|NCT00880399|144506853|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.44||||0.0928|TWO_SIDED|95.0|-0.95|0.07|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg at Week 2||0.07|-0.95|0.0928
72489409|NCT00880399|144506853|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.32||||0.2937|TWO_SIDED|95.0|-0.93|0.28|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg at Week 4||0.28|-0.93|0.2937
72489410|NCT00880399|144506853|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.59||||0.0587|TWO_SIDED|95.0|-1.2|0.02|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg at Week 4||0.02|-1.20|0.0587
72489411|NCT00880399|144506853|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.45||||0.195|TWO_SIDED|95.0|-1.14|0.23|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg at Week 6||0.23|-1.14|0.1950
72489412|NCT00880399|144506853|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.7||||0.0498|TWO_SIDED|95.0|-1.4|0.0|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg at Week 6||-0.00|-1.40|0.0498
72489413|NCT00880399|144506854|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|2.14||||0.1731|TWO_SIDED|95.0|0.72|6.4|||Regression, Logistic|||Placebo Vs Orvepitant 30 mg at Week 1||6.40|0.72|0.1731
72489414|NCT00880399|144506854|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|0.77||||0.7084|TWO_SIDED|95.0|0.2|2.97|||Regression, Logistic|||Placebo Vs Orvepitant 60 mg at Week 1||2.97|0.20|0.7084
72489415|NCT00880399|144506854|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|2.6||||0.0247|TWO_SIDED|95.0|1.13|5.98|||Regression, Logistic|||Placebo Vs Orvepitant 30 mg at Week 2||5.98|1.13|0.0247
72516175|NCT01797445|144563408|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentages|3.1||||0.13|TWO_SIDED|95.002|-1.0|7.1|||Cochran-Mantel-Haenszel|P-value was from the Cochran-Mantel-Haenszel (CMH) test stratified by baseline HIV-1 RNA (≤ 100,000 or \> 100,000 copies/mL) and region (US vs ex-US).|The difference in percentages and its 95.002% confidence interval (CI) were calculated based on the Mantel-Haenszel (MH) proportions adjusted by baseline HIV-1 RNA and region stratum.|Null hypothesis: the E/C/F/TAF group was ≥ 12% worse than the E/C/F/TDF group with respect to the percentage of participants achieving HIV-1 RNA \< 50 copies/mL at Week 48; alternative hypothesis: the E/C/F/TAF group was \< 12% worse than the E/C/F/TDF group.||7.1|-1.0|0.13
72516176|NCT04547998|144563425|SUPERIORITY|The difference in the proportion of responders (RECELL-Control) was tested for superiority of RECELL treatment (with a 10% superiority margin). For the null hypothesis to be rejected and super-superiority of RECELL to Control to be established, the lower limit of the 2-sided 95% CI of the difference in the proportion of responders (RECELL-Control) had to be greater than 10%.||||||0.012|||||||continuity-corrected method|Liu et al 2002||||||0.012
72624359|NCT00863304|144778631|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.08||0.012|TWO_SIDED|95.0|-0.35|-0.04||P-value was based on pairwise comparisons.|ANCOVA|||Week 2: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.04|-0.35|0.012
72489416|NCT00880399|144506854|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.8||||0.1862|TWO_SIDED|95.0|0.75|4.3|||Regression, Logistic|||Placebo Vs Orvepitant 60 mg at Week 2||4.30|0.75|0.1862
72489417|NCT00880399|144506854|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.87||||0.063|TWO_SIDED|95.0|0.97|3.61|||Regression, Logistic|||Placebo Vs Orvepitant 30 mg at Week 4||3.61|0.97|0.0630
72489418|NCT00880399|144506854|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.65||||0.1413|TWO_SIDED|95.0|0.85|3.23|||Regression, Logistic|||Placebo Vs Orvepitant 60 mg at Week 4||3.23|0.85|0.1413
72489419|NCT00880399|144506854|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.77||||0.0806|TWO_SIDED|95.0|0.93|3.37|||Regression, Logistic|||Placebo Vs Orvepitant 30 mg at Week 6||3.37|0.93|0.0806
72489420|NCT00880399|144506854|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.53||||0.2007|TWO_SIDED|95.0|0.8|2.92|||Regression, Logistic|||Placebo Vs Orvepitant 60 mg at Week 6||2.92|0.80|0.2007
72489421|NCT00880399|144506855|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.09||||0.2523|TWO_SIDED|95.0|-0.25|0.07|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg at Week 1||0.07|-0.25|0.2523
72489422|NCT00880399|144506855|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.09||||0.2639|TWO_SIDED|95.0|-0.25|0.07|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg at Week 1||0.07|-0.25|0.2639
72489423|NCT00880399|144506855|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.37||||0.0004|TWO_SIDED|95.0|-0.58|-0.17|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg at Week 2||-0.17|-0.58|0.0004
72489424|NCT00880399|144506855|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.22||||0.0348|TWO_SIDED|95.0|-0.43|-0.02|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg at Week 2||-0.02|-0.43|0.0348
72489425|NCT00880399|144506855|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.34||||0.0166|TWO_SIDED|95.0|-0.62|-0.06|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg at Week 4||-0.06|-0.62|0.0166
72489426|NCT00880399|144506855|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.46||||0.0014|TWO_SIDED|95.0|-0.75|-0.18|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg at Week 4||-0.18|-0.75|0.0014
72489427|NCT00880399|144506855|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.45||||0.0099|TWO_SIDED|95.0|-0.79|-0.11|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg at Week 6||-0.11|-0.79|0.0099
72489428|NCT00880399|144506855|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.49||||0.0059|TWO_SIDED|95.0|-0.83|-0.14|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg at Week 6||-0.14|-0.83|0.0059
72489429|NCT00880399|144506856|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.48||||0.5473|TWO_SIDED|95.0|-2.04|1.08|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg at Week 1||1.08|-2.04|0.5473
72489430|NCT00880399|144506856|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.02||||0.9814|TWO_SIDED|95.0|-1.56|1.6|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg at Week 1||1.60|-1.56|0.9814
72489431|NCT00880399|144506856|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.51||||0.0515|TWO_SIDED|95.0|-3.03|0.01|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg at Week 2||0.01|-3.03|0.0515
72489432|NCT00880399|144506856|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.56||||0.468|TWO_SIDED|95.0|-2.09|0.96|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg at Week 2||0.96|-2.09|0.4680
72489433|NCT00880399|144506856|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.22||||0.1757|TWO_SIDED|95.0|-2.98|0.55|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg at Week 4||0.55|-2.98|0.1757
72489434|NCT00880399|144506856|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.15||||0.2048|TWO_SIDED|95.0|-2.93|0.63|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg at Week 4||0.63|-2.93|0.2048
72489435|NCT00880399|144506856|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.16||||0.0312|TWO_SIDED|95.0|-4.12|-0.2|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg at Week 6||-0.20|-4.12|0.0312
72489436|NCT00880399|144506856|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.34||||0.0202|TWO_SIDED|95.0|-4.31|-0.37|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg at Week 6||-0.37|-4.31|0.0202
72624360|NCT00863304|144778631|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.08||0.113|TWO_SIDED|95.0|-0.28|0.03||P-value was based on pairwise comparisons.|ANCOVA|||Week 2: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||0.03|-0.28|0.113
72624361|NCT00863304|144778631|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.34|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-0.49|-0.18||P-value was based on pairwise comparisons.|ANCOVA|||Week 2: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.18|-0.49|<0.001
72404317|NCT03712410|144315308|OTHER|Group Comparisons||||||0.0155||||||p-value for Caregiver Quality of Life Index (CQLI-R) for arm Traditional PISCES|Wilcoxon Signed Rank Test|||||||0.0155
72489437|NCT00880399|144506857|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.45||||0.7246|TWO_SIDED|95.0|-20.38|29.28|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg, TST at Week 1||29.28|-20.38|0.7246
72489438|NCT00880399|144506857|SUPERIORITY_OR_OTHER||Mean Difference (Net)|27.36||||0.0332|TWO_SIDED|95.0|2.2|52.52|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg, TST at Week 1||52.52|2.20|0.0332
72489439|NCT00880399|144506857|SUPERIORITY_OR_OTHER||Mean Difference (Net)|8.12||||0.5439|TWO_SIDED|95.0|-18.18|34.41|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg, TST at Week 2||34.41|-18.18|0.5439
72489440|NCT00880399|144506857|SUPERIORITY_OR_OTHER||Mean Difference (Net)|13.52||||0.3127|TWO_SIDED|95.0|-12.8|39.85|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg, TST at Week 2||39.85|-12.80|0.3127
72516177|NCT04547998|144563426|SUPERIORITY||||||<|0.001||||||P-value based on Wilcoxon signed rank test at 2-sided 0.05 significance level. The Wilcoxon signed rank test was based on the following repigmentation categories: 0% to 25%, 26% to 50%, 51% to 79%, and 80% to 100%.|Wilcoxon (Mann-Whitney)|||||||<0.001
72516178|NCT04547998|144563427|SUPERIORITY|||||||1||||||2-sided (0.05 significance level), based on 19 participants with assessable color matching outcomes for both treatments|Wilcoxon (Mann-Whitney)|||||||1.000
72516179|NCT01595438|144563428|NON_INFERIORITY_OR_EQUIVALENCE|-12.5%|Difference of symp resolution rates|4.0|||||TWO_SIDED|95.0|-2.39|10.42|||Unstratified Miettinen & Nurminen method|||H0: Difference (CAZ-AVI treatment group minus Doripenem treatment group) of symptomatic resolution rates ≤ non-inferiority margin||10.42|-2.39|
72624362|NCT00863304|144778631|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.14|STANDARD_ERROR_OF_MEAN|0.08||0.076|TWO_SIDED|95.0|-0.01|0.29||P-value was based on pairwise comparisons.|ANCOVA|||Week 2: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||0.29|-0.01|0.076
72516180|NCT01595438|144563429|NON_INFERIORITY_OR_EQUIVALENCE|-12.5%|Diff of favorable combined resp rates|6.7|||||TWO_SIDED|95.0|0.3|13.12|||Unstratified Miettinen & Nurminen method|||H0: Difference (CAZ-AVI treatment group minus Doripenem treatment group) of favorable combined response rates ≤ non-inferiority margin||13.12|0.30|
72404318|NCT03712410|144315308|OTHER|Group Comparisons|||||<|0.0001||||||p-value for Generalised Anxiety Disorder Assessment (GAD-7) for arm Online PISCES|Wilcoxon Signed Rank Test|||||||<0.0001
72489441|NCT00880399|144506857|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-17.51||||0.2419|TWO_SIDED|95.0|-46.9|11.89|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg, TST at Week 4||11.89|-46.90|0.2419
72489442|NCT00880399|144506857|SUPERIORITY_OR_OTHER||Median Difference (Net)|21.11||||0.1606|TWO_SIDED|95.0|-8.43|50.64|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg, TST at Week 4||50.64|-8.43|0.1606
72489443|NCT00880399|144506857|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.48||||0.7412||95.0|-22.21|31.16|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg, TST at Week 6||31.16|-22.21|0.7412
72489444|NCT00880399|144506857|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.47||||0.3974|TWO_SIDED|95.0|-15.19|38.14|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg, TST at Week 6||38.14|-15.19|0.3974
72489445|NCT00880399|144506857|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-11.52||||0.1397|TWO_SIDED|95.0|-26.83|3.79|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg, SOL at Week 1||3.79|-26.83|0.1397
72489446|NCT00880399|144506857|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-23.9||||0.0026|TWO_SIDED|95.0|-39.4|-8.41|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg, SOL at Week 1||-8.41|-39.40|0.0026
72489447|NCT00880399|144506857|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-7.67||||0.3206|TWO_SIDED|95.0|-22.85|7.5|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg, SOL at Week 2||7.50|-22.85|0.3206
72489448|NCT00880399|144506857|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-24.67||||0.0015|TWO_SIDED|95.0|-39.86|-9.49|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg, SOL at Week 2||-9.49|-39.86|0.0015
72489449|NCT00880399|144506857|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-10.71||||0.2157|TWO_SIDED|95.0|-27.7|6.28|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg, SOL at Week 4||6.28|-27.70|0.2157
72489450|NCT00880399|144506857|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-15.31||||0.0784|TWO_SIDED|95.0|-32.37|1.75|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg, SOL at Week 4||1.75|-32.37|0.0784
72516181|NCT01595438|144563430|NON_INFERIORITY_OR_EQUIVALENCE|-12.5%|Diff of favorable response rates|6.4|||||TWO_SIDED|95.0|0.33|12.36|||Unstratified Miettinen & Nurminen method|||H0: Difference (CAZ-AVI treatment group minus Doripenem treatment group) of favorable response rates ≤ non-inferiority margin||12.36|0.33|
72516182|NCT01595438|144563431|SUPERIORITY_OR_OTHER||Diff of favorable response rates|0.4|||||TWO_SIDED|95.0|-2.7|3.56|||Unstratified Miettinen & Nurminen method|||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of favorable response rates||3.56|-2.70|
72489451|NCT00880399|144506857|SUPERIORITY_OR_OTHER||Mean Difference (Net)|6.84||||0.3345|TWO_SIDED|95.0|-7.09|20.78|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg, SOL at Week 6||20.78|-7.09|0.3345
72489452|NCT00880399|144506857|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.25||||0.6471|TWO_SIDED|95.0|-17.19|10.7|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg, SOL at Week 6||10.70|-17.19|0.6471
72489453|NCT00880399|144506857|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.4||||0.8071|TWO_SIDED|95.0|-16.95|21.75|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg, WTSO at Week 1||21.75|-16.95|0.8071
72489454|NCT00880399|144506857|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-9.3||||0.3564|TWO_SIDED|95.0|-29.11|10.52|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg, WTSO at Week 1||10.52|-29.11|0.3564
72489455|NCT00880399|144506857|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-15.86||||0.122|TWO_SIDED|95.0|-36.0|4.28|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg, WTSO at Week 2||4.28|-36.00|0.1220
72489456|NCT00880399|144506857|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-22.25||||0.0313|TWO_SIDED|95.0|-42.49|-2.01|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg, WTSO at Week 2||-2.01|-42.49|0.0313
72489457|NCT00880399|144506857|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.15||||0.8861|TWO_SIDED|95.0|-27.45|31.76|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg, WTSO at Week 4||31.76|-27.45|0.8861
72489458|NCT00880399|144506857|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.67||||0.9132|TWO_SIDED|95.0|-31.87|28.53|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg, WTSO at Week 4||28.53|-31.87|0.9132
72489459|NCT00880399|144506857|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.09||||0.7844|TWO_SIDED|95.0|-33.55|25.37|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg, WTSO at Week 6||25.37|-33.55|0.7844
72489460|NCT00880399|144506857|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.9||||0.8497|TWO_SIDED|95.0|-27.33|33.14|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg, WTSO at Week 6||33.14|-27.33|0.8497
72516183|NCT01595438|144563432|SUPERIORITY_OR_OTHER||Diff of favorable response rates|7.3|||||TWO_SIDED|95.0|0.68|13.81|||Unstratified Miettinen & Nurminen method|||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of favorable response rates||13.81|0.68|
72516184|NCT01595438|144563433|SUPERIORITY_OR_OTHER||Diff of favorable response rates|0.2|||||TWO_SIDED|95.0|-1.21|1.72|||Unstratified Miettinen & Nurminen method|||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of favorable response rates||1.72|-1.21|
72489461|NCT00880399|144506858|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.22||||0.4814|TWO_SIDED|95.0|-0.83|0.39|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg at Week 1||0.39|-0.83|0.4814
72489462|NCT00880399|144506858|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.16||||0.6179|TWO_SIDED|95.0|-0.47|0.79|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg at Week 1||0.79|-0.47|0.6179
72489463|NCT00880399|144506858|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.11||||0.5022|TWO_SIDED|95.0|-0.44|0.21|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg at Week 2||0.21|-0.44|0.5022
72489464|NCT00880399|144506858|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.25||||0.1389|TWO_SIDED|95.0|-0.57|0.08|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg at Week 2||0.08|-0.57|0.1389
72489465|NCT00880399|144506858|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.01||||0.9663|TWO_SIDED|95.0|-0.36|0.38|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg at Week 4||0.38|-0.36|0.9663
72489466|NCT00880399|144506858|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.29||||0.1311|TWO_SIDED|95.0|-0.67|0.09|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg at Week 4||0.09|-0.67|0.1311
72489467|NCT00880399|144506858|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.31||||0.1362|TWO_SIDED|95.0|-0.73|0.1|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg at Week 6||0.10|-0.73|0.1362
72489468|NCT00880399|144506858|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.48||||0.0275|TWO_SIDED|95.0|-0.91|-0.05|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg at Week 6||-0.05|-0.91|0.0275
72489469|NCT00880399|144506859|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.52||||0.0606|TWO_SIDED|95.0|-0.02|1.06|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg, SQ at Week 1||1.06|-0.02|0.0606
72489470|NCT00880399|144506859|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.69||||0.0132|TWO_SIDED|95.0|0.15|1.24|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg, SQ at Week 1||1.24|0.15|0.0132
72489471|NCT00880399|144506859|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.94||||0.001|TWO_SIDED|95.0|0.38|1.5|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg, SQ at Week 2||1.50|0.38|0.0010
72489472|NCT00880399|144506859|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.84||||0.0034|TWO_SIDED|95.0|0.28|1.4|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg, SQ at Week 2||1.40|0.28|0.0034
72489473|NCT00880399|144506859|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.13||||0.6692|TWO_SIDED|95.0|-0.47|0.72|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg, SQ at Week 4||0.72|-0.47|0.6692
72489474|NCT00880399|144506859|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.82||||0.0078|TWO_SIDED|95.0|0.22|1.42|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg, SQ at Week 4||1.42|0.22|0.0078
72489475|NCT00880399|144506859|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.66||||0.044|TWO_SIDED|95.0|0.02|1.3|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg, SQ at Week 6||1.30|0.02|0.0440
72489476|NCT00880399|144506859|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.77||||0.0181|TWO_SIDED|95.0|0.13|1.41|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg, SQ at Week 6||1.41|0.13|0.0181
72489477|NCT00880399|144506859|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.39||||0.1484|TWO_SIDED|95.0|-0.14|0.92|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg, RVS at Week 1||0.92|-0.14|0.1484
72489478|NCT00880399|144506859|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.7||||0.0108|TWO_SIDED|95.0|0.16|1.24|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg, RVS at Week 1||1.24|0.16|0.0108
72489479|NCT00880399|144506859|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.6||||0.0361||95.0|0.04|1.16|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg, RVS at Week 2||1.16|0.04|0.0361
72624363|NCT00863304|144778631|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.21|STANDARD_ERROR_OF_MEAN|0.08||0.007|TWO_SIDED|95.0|0.06|0.37||P-value was based on pairwise comparisons.|ANCOVA|||Week 2: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||0.37|0.06|0.007
72624364|NCT00863304|144778631|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.41|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-0.57|-0.26||P-value was based on pairwise comparisons.|ANCOVA|||Week 4: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.26|-0.57|<0.001
72489480|NCT00880399|144506859|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.58||||0.0418|TWO_SIDED|95.0|0.02|1.15|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg, RVS at Week 2||1.15|0.02|0.0418
72624365|NCT00863304|144778631|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.41|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-0.57|-0.25||P-value was based on pairwise comparisons.|ANCOVA|||Week 4: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.25|-0.57|<0.001
72489481|NCT00880399|144506859|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.03||||0.9305|TWO_SIDED|95.0|-0.64|0.58|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg, RVS at Week 4||0.58|-0.64|0.9305
72489482|NCT00880399|144506859|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.77||||0.0141|TWO_SIDED|95.0|0.16|1.39|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg, RVS at Week 4||1.39|0.16|0.0141
72516185|NCT01595438|144563434|SUPERIORITY_OR_OTHER||Diff of favorable response rates|8.8|||||TWO_SIDED|95.0|2.27|15.24|||Unstratified Miettinen & Nurminen method|||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of favorable response rates||15.24|2.27|
72624366|NCT00863304|144778631|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.29|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-0.45|-0.13||P-value was based on pairwise comparisons.|ANCOVA|||Week 4: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.13|-0.45|<0.001
72489483|NCT00880399|144506859|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.65||||0.0562|TWO_SIDED|95.0|-0.02|1.31|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg, RVS at Week 6||1.31|-0.02|0.0562
72516186|NCT01595438|144563435|SUPERIORITY_OR_OTHER||Diff of favorable response rates|10.9|||||TWO_SIDED|95.0|2.86|18.85|||Unstratified Miettinen & Nurminen method|||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of favorable response rates||18.85|2.86|
72516187|NCT01595438|144563436|SUPERIORITY_OR_OTHER||Diff of favorable response rates|0.2|||||TWO_SIDED|95.0|-1.17|1.68|||Unstratified Miettinen & Nurminen method|||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of favorable response rates||1.68|-1.17|
72624367|NCT00863304|144778631|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.08||0.12|TWO_SIDED|95.0|-0.29|0.03||P-value was based on pairwise comparisons.|ANCOVA|||Week 4: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||0.03|-0.29|0.120
72624368|NCT00863304|144778631|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.08||0.126|TWO_SIDED|95.0|-0.29|0.04||P-value was based on pairwise comparisons.|ANCOVA|||Week 4: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||0.04|-0.29|0.126
72404319|NCT03712410|144315308|OTHER|Group Comparisons|||||<|0.0001||||||p-value for Patient Health Questionnaire 9 (PHQ9) for arm Online PISCES|Wilcoxon Signed Rank Test|||||||<0.0001
72624369|NCT00863304|144778631|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.46|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-0.62|-0.3||P-value was based on pairwise comparisons.|ANCOVA|||Week 8: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.30|-0.62|<0.001
72489484|NCT00880399|144506859|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.74||||0.0296|TWO_SIDED|95.0|0.07|1.4|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg, RVS at Week 6||1.40|0.07|0.0296
72489485|NCT00880399|144506863|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.2||||0.0735|TWO_SIDED|95.0|-0.21|4.61|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg at Week 1||4.61|-0.21|0.0735
72489486|NCT00880399|144506863|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.35||||0.2905|TWO_SIDED|95.0|-1.17|3.86|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg at Week 1||3.86|-1.17|0.2905
72489487|NCT00880399|144506863|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.05||||0.4327|TWO_SIDED|95.0|-1.6|3.7|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg at Week 2||3.70|-1.60|0.4327
72489488|NCT00880399|144506863|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.01||||0.4642|TWO_SIDED|95.0|-1.73|3.75|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg at Week 2||3.75|-1.73|0.4642
72489489|NCT00880399|144506863|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.48||||0.285|TWO_SIDED|95.0|-1.26|4.23|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg at Week 4||4.23|-1.26|0.2850
72489490|NCT00880399|144506863|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.75||||0.5984|TWO_SIDED|95.0|-2.08|3.59|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg at Week 4||3.59|-2.08|0.5984
72489491|NCT00880399|144506863|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.21||||0.4192|TWO_SIDED|95.0|-1.76|4.19|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg at Week 6||4.19|-1.76|0.4192
72489492|NCT00880399|144506863|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.64||||0.6766|TWO_SIDED|95.0|-2.42|3.71|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg at Week 6||3.71|-2.42|0.6766
72489493|NCT00880399|144506864|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0||||0.9951|TWO_SIDED|95.0|-1.26|1.25|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg at Week 1||1.25|-1.26|0.9951
72624370|NCT00863304|144778631|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.41|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-0.57|-0.25||P-value was based on pairwise comparisons.|ANCOVA|||Week 8: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.25|-0.57|<0.001
72489494|NCT00880399|144506864|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.08||||0.894|TWO_SIDED|95.0|-1.17|1.34|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg at Week 1||1.34|-1.17|0.8940
72489495|NCT00880399|144506864|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.17||||0.8195|TWO_SIDED|95.0|-1.61|1.28|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg at Week 2||1.28|-1.61|0.8195
72489496|NCT00880399|144506864|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.6||||0.4106|TWO_SIDED|95.0|-0.84|2.05|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg at Week 2||2.05|-0.84|0.4106
72489497|NCT00880399|144506864|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.07||||0.9403|TWO_SIDED|95.0|-1.71|1.85|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg at Week 4||1.85|-1.71|0.9403
72489498|NCT00880399|144506864|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.58||||0.5206|TWO_SIDED|95.0|-2.36|1.2|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg at Week 4||1.20|-2.36|0.5206
72489499|NCT00880399|144506864|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.36||||0.714|TWO_SIDED|95.0|-2.3|1.58|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg at Week 6||1.58|-2.30|0.7140
72489500|NCT00880399|144506864|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.26||||0.0234|TWO_SIDED|95.0|-4.22|-0.31|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg at Week 6||-0.31|-4.22|0.0234
72489501|NCT04353284|144506865|SUPERIORITY||Mean Difference (Net)|0.74||||0.06|TWO_SIDED|95.0|-0.03|1.51|||Mixed Models Analysis|||This analysis compares the change from baseline between treatment arms.||1.51|-0.03|0.06
72489502|NCT04353284|144506866|SUPERIORITY||Mean Difference (Net)|0.06||||0.87|TWO_SIDED|95.0|-0.7|0.83|||Mixed Models Analysis|||||0.83|-0.70|0.87
72489503|NCT04353284|144506867|SUPERIORITY||Mean Difference (Net)|0.23||||0.69|TWO_SIDED|95.0|-0.94|1.4|||Mixed Models Analysis|||||1.4|-0.94|0.69
72516188|NCT01595438|144563437|SUPERIORITY_OR_OTHER||Diff of favorable response rates|7.3|||||TWO_SIDED|95.0|0.88|13.74|||Unstratified Miettinen & Nurminen method|||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of favorable response rates||13.74|0.88|
72624371|NCT00863304|144778631|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.25|STANDARD_ERROR_OF_MEAN|0.08||0.003|TWO_SIDED|95.0|-0.41|-0.08||P-value was based on pairwise comparisons.|ANCOVA|||Week 8: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.08|-0.41|0.003
72624372|NCT00863304|144778631|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.08||0.009|TWO_SIDED|95.0|-0.38|-0.05||P-value was based on pairwise comparisons.|ANCOVA|||Week 8: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.05|-0.38|0.009
72489504|NCT04353284|144506868|SUPERIORITY||Odds Ratio (OR)|1.3||||0.71|TWO_SIDED|95.0|0.33|5.09|||GEE|||Nasopharyngeal Swab Samples analyzed.||5.09|0.33|0.71
72489505|NCT04353284|144506868|SUPERIORITY||Odds Ratio (OR)|0.4||||0.17|TWO_SIDED|95.0|0.11|1.47|||GEE|Within subject correlation is controlled by specifying a compound symmetry R-side structure in the model.||Saliva RT-PCR samples analyzed.||1.47|0.11|0.17
72489506|NCT04353284|144506869|SUPERIORITY||Odds Ratio (OR)|3.05||||0.03|TWO_SIDED|95.0|1.12|8.26|||GEE|Within subject correlation is controlled by specifying a compound symmetry R-side structure in the model.||||8.26|1.12|0.03
72489507|NCT04353284|144506869|SUPERIORITY||Odds Ratio (OR)|1.23||||0.68|TWO_SIDED|95.0|0.47|3.23|||GEE|Within subject correlation is controlled by specifying a compound symmetry R-side structure in the model.||Saliva RT-PCR samples analyzed.||3.23|0.47|0.68
72489508|NCT04353284|144506870|SUPERIORITY||Odds Ratio (OR)|6.28||||0.1|TWO_SIDED|95.0|0.7|56.6|||GEE|Within subject correlation is controlled by specifying a compound symmetry R-side structure in the model.||||56.60|0.70|0.10
72489509|NCT04353284|144506870|SUPERIORITY||Odds Ratio (OR)|0.9||||0.87|TWO_SIDED|95.0|0.25|3.23|||GEE|Within subject correlation is controlled by specifying a compound symmetry R-side structure in the model.||Saliva RT-PCR samples analyzed.||3.23|0.25|0.87
72489510|NCT04353284|144506871|SUPERIORITY||Mean Difference (Net)|-6.6||||0.02|TWO_SIDED|95.0|-12.1|-1.2|||Mixed Models Analysis|||||-1.2|-12.1|0.02
72489511|NCT04353284|144506872|SUPERIORITY||Mean Difference (Net)|-2.1||||0.48|TWO_SIDED|95.0|-7.9|3.7|||Mixed Models Analysis|||||3.7|-7.9|0.48
72489512|NCT04353284|144506873|SUPERIORITY||Mean Difference (Net)|1.0||||0.16|TWO_SIDED|95.0|-0.4|2.3|||Mixed Models Analysis|||||2.3|-0.4|0.16
72489513|NCT04353284|144506874|SUPERIORITY||Mean Difference (Net)|0.7||||0.34|TWO_SIDED|95.0|-0.7|2.1|||Mixed Models Analysis|||||2.1|-0.7|0.34
72489514|NCT00676676|144506891|SUPERIORITY_OR_OTHER|||||||0.002|||||||t-test, 2 sided|||Baseline versus 2-week||||0.002
72489515|NCT00676676|144506891|SUPERIORITY_OR_OTHER|||||||0.004|||||||t-test, 2 sided|||Baseline versus 8-week||||0.004
72489516|NCT03129321|144506892|EQUIVALENCE|Equivalence margin: +/-20%|Difference in proportions|4.24|||||TWO_SIDED|90.0|-5.05|13.54||||||||13.54|-5.05|
72489517|NCT03129321|144506893|SUPERIORITY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
72489518|NCT03129321|144506893|SUPERIORITY|||||||0.0004|||||||Cochran-Mantel-Haenszel|||||||0.0004
72489519|NCT03129321|144506894|EQUIVALENCE|Equivalence margin: +/-20%|Difference in proportions|2.85|||||TWO_SIDED|90.0|-6.29|11.98||||||||11.98|-6.29|
72489520|NCT03129321|144506895|EQUIVALENCE|Equivalence margin: +/-20%|Difference in proportions|-0.02|||||TWO_SIDED|90.0|-8.29|8.26||||||||8.26|-8.29|
72489521|NCT03129321|144506896|SUPERIORITY|||||||0.002|||||||Cochran-Mantel-Haenszel|||||||0.0020
72489522|NCT03129321|144506896|SUPERIORITY|||||||0.0076|||||||Cochran-Mantel-Haenszel|||||||0.0076
72489523|NCT03129321|144506897|SUPERIORITY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
72489524|NCT03129321|144506897|SUPERIORITY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
72489525|NCT01148537|144506913|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.91|||<|0.001|TWO_SIDED|90.0|3.4|8.4|||ANCOVA|ANCOVA model with baseline QTci as a covariate and with sex and treatment as effects in the model.||||8.4|3.4|< .001
72489526|NCT01148537|144506914|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.39||||0.77|TWO_SIDED|90.0|-1.8|2.6|||ANCOVA||For the comparison of BTDS to placebo, the subjects randomized to moxifloxacin were excluded.|||2.6|-1.8|.770
72489527|NCT01148537|144506915|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.86|||<|0.001|TWO_SIDED|90.0|3.3|8.4|||ANCOVA|ANCOVA model with baseline QTci as a covariate and with sex and treatment as effects in the model.||Day 13 analysis||8.4|3.3|< .001
72489528|NCT01148537|144506916|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.64|||<|0.001|TWO_SIDED|90.0|5.4|9.9|||ANCOVA|ANCOVA model with average baseline as a covariate, and with gender and treatment as main effects||||9.9|5.4|< .001
72404320|NCT03712410|144315308|OTHER|Group Comparisons||||||0.0504||||||p-value for Caregiver Quality of Life Index (CQLI-R) for arm Online PISCES|Wilcoxon Signed Rank Test|||||||0.0504
72404321|NCT00746941|144315398|SUPERIORITY_OR_OTHER|||||||0.7132|||||||Student's t-test|||||||0.7132
72489529|NCT01148537|144506917|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.13||||0.936|TWO_SIDED|90.0|-2.9|2.6|||ANCOVA|||Day 6 analysis||2.6|-2.9|.936
72516189|NCT01595438|144563438|SUPERIORITY_OR_OTHER||Diff of favorable response rates|9.7|||||TWO_SIDED|95.0|1.72|17.55|||Unstratified Miettinen & Nurminen method|||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of favorable response rates||17.55|1.72|
72516190|NCT01595438|144563439|SUPERIORITY_OR_OTHER||Diff of clinical cure rates|-1.4|||||TWO_SIDED|95.0|-4.07|1.02|||Unstratified Miettinen & Nurminen method|||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of clinical cure rates||1.02|-4.07|
72516191|NCT01595438|144563440|SUPERIORITY_OR_OTHER||Diff of clinical cure rates|-0.1|||||TWO_SIDED|95.0|-4.23|4.03|||Unstratified Miettinen & Nurminen method|||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of clinical cure rates||4.03|-4.23|
72624373|NCT00863304|144778631|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.08||0.052|TWO_SIDED|95.0|-0.32|0.0||P-value was based on pairwise comparisons.|ANCOVA|||Week 8: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||0.00|-0.32|0.052
72516192|NCT01595438|144563441|SUPERIORITY_OR_OTHER||Diff of clinical cure rates|1.3|||||TWO_SIDED|95.0|-3.71|6.3|||Unstratified Miettinen & Nurminen method|||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of clinical cure rates||6.30|-3.71|
72516193|NCT01595438|144563442|SUPERIORITY_OR_OTHER||Diff of clinical cure rates|-1.3|||||TWO_SIDED|95.0|-3.64|0.55|||Unstratified Miettinen & Nurminen method|||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of clinical cure rates||0.55|-3.64|
72404322|NCT00746941|144315399|SUPERIORITY_OR_OTHER|||||||0.9086|||||||Student's t-test|||||||0.9086
72516194|NCT01595438|144563443|SUPERIORITY_OR_OTHER||Diff of clinical cure rates|1.2|||||TWO_SIDED|95.0|-2.03|4.56|||Unstratified Miettinen & Nurminen method|||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of clinical cure rates||4.56|-2.03|
72516195|NCT01595438|144563444|SUPERIORITY_OR_OTHER||Diff of clinical cure rates|2.2|||||TWO_SIDED|95.0|-2.9|7.24|||Unstratified Miettinen & Nurminen method|||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of clinical cure rates||7.24|-2.90|
72516196|NCT01595438|144563445|SUPERIORITY_OR_OTHER||Diff of clinical cure rates|-1.9|||||TWO_SIDED|95.0|-4.3|0.04|||Unstratified Miettinen & Nurminen method|||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of clinical cure rates||0.04|-4.30|
72516197|NCT01595438|144563446|SUPERIORITY_OR_OTHER||Diff of clinical cure rates|1.1|||||TWO_SIDED|95.0|-2.07|4.32|||Unstratified Miettinen & Nurminen method|||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of clinical cure rates||4.32|-2.07|
72516198|NCT01595438|144563447|SUPERIORITY_OR_OTHER||Diff of clinical cure rates|2.0|||||TWO_SIDED|95.0|-2.94|6.91|||Unstratified Miettinen & Nurminen method|||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of clinical cure rates||6.91|-2.94|
72516199|NCT01595438|144563448|SUPERIORITY_OR_OTHER||Diff of clinical cure rates|-0.1|||||TWO_SIDED|95.0|-1.99|1.61|||Unstratified Miettinen & Nurminen method|||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of clinical cure rates||1.61|-1.99|
72624374|NCT00863304|144778631|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.41|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-0.57|-0.25||P-value was based on pairwise comparisons.|ANCOVA|||Week 12: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.25|-0.57|<0.001
72404323|NCT03316885|144315408|OTHER|The performance target in support of the primary effectiveness was percentage of eyes achieving objective monocular BCDVA at 1 year postoperative (Visit 5A) compared to the a priori SPE percentage of 92.5%. This is for the All Implanted Analysis Set (AAS) (as reported in EN ISO 11979-7:2014).|Comparison|100.0|||||ONE_SIDED|95.0||100.0||||||||100.0||
72404324|NCT03316885|144315409|OTHER|The performance target in support of the primary effectiveness was percentage of eyes achieving objective monocular BCDVA at 1 year postoperative (Visit 5A) compared to the a priori SPE percentage of 92.5%. This is for the All Implanted Analysis Set (AAS) (as reported in EN ISO 11979-7:2014).|Comparison|100.0|||||ONE_SIDED|95.0||100.0||||||||100.0||
72489530|NCT01148537|144506917|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.16|||<|0.001|TWO_SIDED|90.0|4.2|10.1|||ANCOVA|||Day 13 analysis||10.1|4.2|< .001
72489531|NCT01148537|144506918|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.23|||<|0.001|TWO_SIDED|90.0|5.5|10.9|||ANCOVA|||Day 6 analysis||10.9|5.5|< .001
72489532|NCT01148537|144506918|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.4|||<|0.001|TWO_SIDED|90.0|4.3|10.5|||ANCOVA|||Day 13 analysis||10.5|4.3|< .001
72489533|NCT01148537|144506919|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.29||||0.427|TWO_SIDED|90.0|-1.4|4.0|||ANCOVA|||Day 6 analysis||4.0|-1.4|.427
72489534|NCT01148537|144506919|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.01||||0.001|TWO_SIDED|90.0|3.2|8.8|||ANCOVA|||Day 13 analysis||8.8|3.2|.001
72489535|NCT01148537|144506920|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.86|||<|0.001|TWO_SIDED|90.0|4.2|9.6|||ANCOVA|||Day 6 analysis||9.6|4.2|< .001
72489536|NCT01148537|144506920|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.68||||0.006|TWO_SIDED|90.0|1.9|7.4|||ANCOVA|||Day 13 analysis||7.4|1.9|.006
72404325|NCT02180412|144315424|OTHER||Slope|7.76||||0.0434|TWO_SIDED|95.0|2.14|13.37|||ANCOVA|||ALA Day 1 vs Day 2||13.37|2.14|.0434
72489537|NCT00393887|144506921|SUPERIORITY_OR_OTHER|||||||0.11|TWO_SIDED||||||Fisher Exact|||Two-sided Fisher's exact test||||0.11
72489538|NCT00777101|144506925|NON_INFERIORITY|Non-inferiority of neratinib vs lapatinib + capecitabine was to be concluded if the upper limit of the 95% confidence interval (CI) for the hazard ratio was 1.15 or less.|Hazard Ratio (HR)|1.19||||0.231|TWO_SIDED|95.0|0.89|1.6|||Log Rank|The log-rank test comparing treatment groups is stratified by region.|The hazard ratio is estimated by stratified Cox model. The Cox model is stratified by region.|||1.60|0.89|0.231
72489539|NCT05376215|144506964|NON_INFERIORITY|The non-inferiority margin of -12.5 was used per the findings from Chisolm, et al (2005), see attached article. In that study, the smallest critical difference for the short term retest difference was 12.5 for the APHAB global score at the 90th percentile. For this study, non-inferiority is confirmed if Fitting Method B is no more than 12.5 percentage points below the mean global benefit score of Fitting Method A.||||||0.806|||||||Mixed Models Analysis|||||||0.806
72516200|NCT01595438|144563449|SUPERIORITY_OR_OTHER||Diff of clinical cure rates|3.7|||||TWO_SIDED|95.0|0.41|7.16|||Unstratified Miettinen & Nurminen method|||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of clinical cure rates||7.16|0.41|
72516201|NCT01595438|144563450|SUPERIORITY_OR_OTHER||Diff of clinical cure rates|4.0|||||TWO_SIDED|95.0|-1.0|9.05|||Unstratified Miettinen & Nurminen method|||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of clinical cure rates||9.05|-1.00|
72516202|NCT01595438|144563451|SUPERIORITY_OR_OTHER||Diff of clin cure rates in All patients|0.0|||||TWO_SIDED|95.0|-10.4|10.1|||Unstratified Miettinen & Nurminen method|||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of clinical cure rates in All patients with a ceftazidime-resistant Gram-negative pathogen||10.1|-10.4|
72516203|NCT01595438|144563452|SUPERIORITY_OR_OTHER||Diff of clin cure rates in All patients|1.4|||||TWO_SIDED|95.0|-7.8|10.2|||Unstratified Miettinen & Nurminen method|||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of clinical cure rates in All patients with a ceftazidime-resistant Gram-negative pathogen||10.2|-7.8|
72516204|NCT01595438|144563453|SUPERIORITY_OR_OTHER||Diff of clin cure rates in All patients|1.2|||||TWO_SIDED|95.0|-7.5|9.2|||Unstratified Miettinen & Nurminen method|||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of clinical cure rates in All patients with a ceftazidime-resistant Gram-negative pathogen||9.2|-7.5|
72516205|NCT01595438|144563454|SUPERIORITY_OR_OTHER||Diff of favorable response rates|2.0|||||TWO_SIDED|95.0|-13.18|16.89|||Unstratified Miettinen & Nurminen method|||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of favorable response rates||16.89|-13.18|
72516206|NCT01595438|144563455|SUPERIORITY_OR_OTHER||Diff of favorable response rates|8.0|||||TWO_SIDED|95.0|-10.03|25.21|||Unstratified Miettinen & Nurminen method|||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of favorable response rates||25.21|-10.03|
72516207|NCT01595438|144563456|SUPERIORITY_OR_OTHER||Diff of favorable response rates|7.5|||||TWO_SIDED|95.0|-9.91|24.01|||Unstratified Miettinen & Nurminen method|||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of favorable response rates||24.01|-9.91|
72516208|NCT01595438|144563457|SUPERIORITY_OR_OTHER|||||||0.038|||||||Log Rank|||H0: No difference in time to first defervescence between treatment groups.||||0.038
72516209|NCT01595438|144563458|SUPERIORITY_OR_OTHER|||||||0.129|||||||Log Rank|||H0: No difference in time to first defervescence between treatment groups.||||0.129
72516210|NCT01595438|144563459|SUPERIORITY_OR_OTHER|||||||0.08|||||||Log Rank|||H0: No difference in time to first defervescence between treatment groups.||||0.080
72516211|NCT01595438|144563460|SUPERIORITY_OR_OTHER|||||||0.155|||||||Log Rank|||H0: No difference in time to first defervescence between treatment groups.||||0.155
72516212|NCT04904614|144563516|SUPERIORITY|||||||0.02|||||||Fisher Exact|||||||0.02
72516213|NCT04904614|144563517|SUPERIORITY|||||||0.13|||||||Chi-squared|||||||0.13
72516214|NCT04904614|144563518|SUPERIORITY|||||||0.6|||||||Fisher Exact|||||||0.6
72516215|NCT04904614|144563520|SUPERIORITY|||||||0.97|||||||Chi-squared|||||||0.97
72404326|NCT02180412|144315424|OTHER||Slope|16.29||||0.0003|TWO_SIDED|95.0|11.32|21.25|||ANCOVA|||ALA Day 1 vs Day 3||21.25|11.32|.0003
72404327|NCT02180412|144315424|OTHER||Slope|15.98||||0.0198|TWO_SIDED|95.0|6.7|25.26|||ANCOVA|||ALA Day 1 vs Day 4||25.26|6.7|.0198
72404328|NCT02180412|144315424|OTHER||Slope|10.69||||0.158|TWO_SIDED|95.0|-1.67|22.49|||ANCOVA|||PBG Day 1 vs Day 2||22.49|-1.67|.158
72489540|NCT05376215|144506965|NON_INFERIORITY|The non-inferiority margin is -1.8 dB. This is based off of work by Killion (2004) in which the critical difference for 4 lists is 1.9 dB at the 95% confidence interval. Killion also found that if all 12 lists are presented, the mean SNR scores will differ by 1.8 dB 5% of the time.||||||0.889|||||||Mixed Models Analysis|||||||0.889
72489541|NCT01947816|144506977|SUPERIORITY||||||<|0.0001|||||||paired t-test|||Change from Baseline at Week 24||||< 0.0001
72489542|NCT01947816|144506977|SUPERIORITY||||||<|0.0001|||||||paired t-test|||Change from Baseline at Week 52||||< 0.0001
72489543|NCT01947816|144506977|SUPERIORITY|||||||0.5512|||||||paired t-test|||Change from Baseline When Discontinued||||0.5512
72516216|NCT00881361|144563525|SUPERIORITY|||||||0.003|||||||t-test, 2 sided|||||||0.003
72516217|NCT01413542|144563531|SUPERIORITY_OR_OTHER||Estimate of Difference||||<|0.001|TWO_SIDED|||||Effect of ACE inhibition on FBF response to bradykinin (p\<0.001). Other comparisons: Effect of DPP4 inhibition on FBF response to bradykinin (p=0.89); Effect of ACE (p=0.16), DPP4 (p=0.82), or combined inhibition (p=0.35) on FBF response to sub P.|Mixed Models Analysis|"Effect of DPP4 inhibition on vasodilator response to GLP-1 (p=0.14) or BNP (p=0.85).~p\<0.05 threshold for statistical significance."||"Group 1: The effect of treatment (placebo, ACE or DPP4 inhibitor, or the combination) on vasodilator response to peptide, measured as forearm blood flow was determined.~Group 2: The effect of treatment (placebo, DPP4 inhibitor) on vasodilator response to peptide, measured as percent change in forearm blood flow was determined."||||<0.001
72489544|NCT01947816|144506977|SUPERIORITY||||||<|0.0001|||||||paired t-test|||Change from Baseline at Final Assessment||||< 0.0001
72489545|NCT01947816|144506979|SUPERIORITY||||||<|0.0001|||||||paired t-test|||Change from Baseline at Week 4||||< 0.0001
72516218|NCT01413542|144563532|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED|||||Effect of DPP4 inhibition on tPA release during sub P in women (p=0.02 vs. placebo).Effect of ACE inhibition on tPA release during sub P in women (p\<0.001); effect of DPP4 inhibition on tPA release during sub P and (p=0.001 vs. ACE inhibition alone).|Mixed Models Analysis|p\<0.05 threshold for statistical significance||||||0.02
72516219|NCT01413542|144563533|SUPERIORITY_OR_OTHER|||||||0.011|TWO_SIDED|||||Effect of combined ACE and DPP4 inhibition on change in heart rate in response to max dose substance P (p=0.011 vs placebo; ).|Wilcoxon signed rank|p\<0.05 threshold for statistical significance.||||||0.011
72568576|NCT04168190|144668501|OTHER|Geometric mean concentration (GMC) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMC Ratio|0.75|||||TWO_SIDED|95.0|0.4|1.41|||||Phase 1: V116 0.5 mL/Phase 1: Pneumovax™23|Serotype 33F||1.41|0.40|
72568577|NCT04168190|144668501|OTHER|Geometric mean concentration (GMC) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMC Ratio|1.32|||||TWO_SIDED|95.0|0.7|2.48|||||Phase 1: V116 1.0 mL/Phase 1: Pneumovax™23|Serotype 33F||2.48|0.70|
72568578|NCT04168190|144668501|OTHER|Geometric mean concentration (GMC) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMC Ratio|0.64|||||TWO_SIDED|95.0|0.37|1.08|||||Phase 1: V116 0.5 mL/Phase 1: Pneumovax™23|Serotype 8||1.08|0.37|
72489546|NCT01947816|144506979|SUPERIORITY||||||<|0.0001|||||||paired t-test|||Change from Baseline at Week 8||||< 0.0001
72489547|NCT01947816|144506979|SUPERIORITY||||||<|0.0001|||||||paired t-test|||Change from Baseline at Week 16||||< 0.0001
72516220|NCT01413542|144563534|SUPERIORITY_OR_OTHER|||||||0.05|TWO_SIDED|||||Effect of combined DPP4 and ACE inhibition on the change in the norepinephrine AV gradient during substance P as compared to treatment with placebo.|Wilcoxon signed rank|||||||0.05
72516221|NCT01413542|144563534|SUPERIORITY_OR_OTHER|||||||0.007|TWO_SIDED|||||Effect of combined DPP4 and ACE inhibition on the change in the norepinephrine AV gradient during substance P as compared to treatment with ACE inhibition alone (p=0.007).|Wilcoxon signed rank|||||||0.007
72516222|NCT01413542|144563535|SUPERIORITY_OR_OTHER|||||||0.01|TWO_SIDED|||||Effect of intra-arterial GLP-1 on venous GLP-1 concentrations during placebo (p=0.01).|wilxocon signed rank test|||||||0.01
72516223|NCT01413542|144563535|SUPERIORITY_OR_OTHER|||||||0.01|TWO_SIDED|||||Effect of intra-arterial GLP-1 on venous GLP-1 concentrations during sitagliptin (p=0.01).|Wilcoxon signed rank|||||||0.01
72516224|NCT01413542|144563535|SUPERIORITY_OR_OTHER|||||||0.04|TWO_SIDED|||||Effect of DPP4 inhibition on venous GLP-1 levels at high dose of intra-arterial GLP-1 (p=0.04 vs. placebo).|Wilcoxon signed rank|||||||0.04
72624375|NCT00863304|144778631|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.31|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-0.48|-0.15||P-value was based on pairwise comparisons.|ANCOVA|||Week 12: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.15|-0.48|<0.001
72489548|NCT01947816|144506979|SUPERIORITY||||||<|0.0001|||||||paired t-test|||Change from Baseline at Week 24||||< 0.0001
72489549|NCT01947816|144506979|SUPERIORITY||||||<|0.0001|||||||paired t-test|||Change from Baseline at Week 52||||< 0.0001
72489550|NCT01947816|144506979|SUPERIORITY||||||<|0.0001|||||||paired t-test|||Change from Baseline when discontinued||||< 0.0001
72489551|NCT01947816|144506979|SUPERIORITY||||||<|0.0001|||||||paired t-test|||Change from Baseline at Final Assessment||||< 0.0001
72489552|NCT01301950|144506984|SUPERIORITY_OR_OTHER|||||||0.54|||||||ANOVA|||The null hypothesis was no difference in skin-to-skin time. The alternative hypothesis was that the TruMatch group time was less than the conventional group. Statistical power was anticipated to be 86% with 40 enrolled subjects based upon a Cohen's D effect size of 1. The Sponsor had difficulty identifying and recruiting sites suitable for participation. The statistically required sample size (N=40) was therefore not obtained, causing the group comparison to be statistically underpowered.||||0.54
72489553|NCT02651584|144506989|NON_INFERIORITY|The p-value was based on the chi square test for non-inferiority with the margin of 10% point.|||||<|0.001|||||||Chi-squared|||||||<0.001
72489554|NCT02651584|144506990|SUPERIORITY|||||||0.004|||||||Wilcoxon Rank-Sum|||including subject self-reported opioid use||||0.004
72489555|NCT02651584|144506990|SUPERIORITY|||||||0.008|||||||Wilcoxon Rank-Sum|||not including self-reported opioid use||||0.008
72489556|NCT02651584|144506992|NON_INFERIORITY_OR_EQUIVALENCE|The p-value was based on the chi square test for non-inferiority with the margin of 15%.||||||0.006|||||||Chi-squared|||||||0.006
72489557|NCT03455491|144507012|SUPERIORITY|||||||0.3541|||||||Gekhan-Wilcoxon test|||||||0.3541
72568579|NCT04168190|144668501|OTHER|Geometric mean concentration (GMC) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMC Ratio|0.99|||||TWO_SIDED|95.0|0.58|1.69|||||Phase 1: V116 1.0 mL/Phase 1: Pneumovax™23|Serotype 8||1.69|0.58|
72568580|NCT04168190|144668501|OTHER|Geometric mean concentration (GMC) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMC Ratio|1.03|||||TWO_SIDED|95.0|0.57|1.85|||||Phase 1: V116 0.5 mL/Phase 1: Pneumovax™23|Serotype 9N||1.85|0.57|
72568581|NCT04168190|144668501|OTHER|Geometric mean concentration (GMC) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMC Ratio|1.64|||||TWO_SIDED|95.0|0.9|2.97|||||Phase 1: V116 1.0 mL/Phase 1: Pneumovax™23|Serotype 9N||2.97|0.90|
72568582|NCT04168190|144668501|OTHER|Geometric mean concentration (GMC) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMC Ratio|1.25|||||TWO_SIDED|95.0|0.67|2.32|||||Phase 1: V116 0.5 mL/Phase 1: Pneumovax™23|Serotype 10A||2.32|0.67|
72568583|NCT04168190|144668501|OTHER|Geometric mean concentration (GMC) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMC Ratio|1.84|||||TWO_SIDED|95.0|0.98|3.45|||||Phase 1: V116 1.0 mL/Phase 1: Pneumovax™23|Serotype 10A||3.45|0.98|
72624376|NCT00863304|144778631|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.08||0.051|TWO_SIDED|95.0|-0.33|0.0||P-value was based on pairwise comparisons.|ANCOVA|||Week 12: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||0.00|-0.33|0.051
72489558|NCT03455491|144507013|SUPERIORITY|||||||0.3597|||||||Gekhan-Wilcoxon test|||||||0.3597
72489559|NCT03455491|144507015|SUPERIORITY|||||||0.4551|||||||ANOVA|one-way ANOVA||||||0.4551
72489560|NCT03317795|144507020|SUPERIORITY|||||||0.11|||||||Wilcoxon (Mann-Whitney)|||||||0.11
72489561|NCT03317795|144507022|SUPERIORITY|||||||0.64|||||||Wilcoxon (Mann-Whitney)|||||||0.64
72489562|NCT03317795|144507023|SUPERIORITY|||||||0.32|||||||Wilcoxon (Mann-Whitney)|||Physical composite score||||0.32
72489563|NCT03317795|144507023|SUPERIORITY|||||||0.26|||||||Wilcoxon (Mann-Whitney)|||Mental composite score||||0.26
72489564|NCT03317795|144507024|SUPERIORITY|||||||0.33|||||||Wilcoxon (Mann-Whitney)|||||||0.33
72489565|NCT03317795|144507025|SUPERIORITY|||||||0.4|||||||Wilcoxon (Mann-Whitney)|||||||0.40
72489566|NCT02424253|144507036|SUPERIORITY||LS Difference|-0.35|||=|0.249|TWO_SIDED|90.0|-1.21|0.51||1-sided p-value.|ANCOVA|The ANCOVA model included baseline value and treatment.||Change from baseline||0.51|-1.21|= 0.249
72489567|NCT02424253|144507037|SUPERIORITY||LS Difference|-5.06|||=|0.01|TWO_SIDED|90.0|-8.66|-1.46||1-sided p-value.|ANCOVA|The ANCOVA model included baseline EASI, stratification variable (worst daily pruritus NRS ≤ 7.5 or \> 7.5) and treatment.||Change from baseline analysis||-1.46|-8.66|= 0.01
72516225|NCT02505542|144563536|SUPERIORITY||Odds Ratio (OR)|18.822|||<|0.001|TWO_SIDED|95.0|9.605|38.864||A fixed sequence testing procedure was used whereby the second test (CZP 200 mg Q4W vs PBO) was interpreted as statistically significant only if the first test (CZP 200 mg Q2W vs PBO) was significant at the 0.05 level as well.|Regression, Logistic|||Odds ratio (and corresponding p-value) resulted from a logistic regression model with factors for treatment, geographic region, and modified New York (mNY) classification for study participants who did not experience a flare. An odds ratio \> 1 indicates a study participant on CZP was more likely not to experience a flare than a study participant on placebo. Penalized maximum likelihood approach was used for logistic regression.||38.864|9.605|<0.001
72516226|NCT02505542|144563536|SUPERIORITY||Odds Ratio (OR)|14.069|||<|0.001|TWO_SIDED|95.0|7.395|27.955||A fixed sequence testing procedure was used whereby the second test (CZP 200 mg Q4W vs PBO) was interpreted as statistically significant only if the first test (CZP 200 mg Q2W vs PBO) was significant at the 0.05 level as well.|Regression, Logistic|||Odds ratio (and corresponding p-value) resulted from a logistic regression model with factors for treatment, geographic region, and modified New York (mNY) classification for study participants who did not experience a flare. An odds ratio \> 1 indicates a study participant on CZP was more likely not to experience a flare than a study participant on placebo. Penalized maximum likelihood approach was used for logistic regression.||27.955|7.395|<0.001
72404329|NCT02180412|144315424|OTHER||Slope|24.52||||0.0127|TWO_SIDED|95.0|11.3|37.74|||ANCOVA|||PGB Day 1 vs Day 3||37.74|11.3|.0127
72404330|NCT02180412|144315424|OTHER||Slope|28.45||||0.0328|TWO_SIDED|95.0|9.64|47.27|||ANCOVA|||PBG Day 1 vs Day 4||47.27|9.64|.0328
72489568|NCT03998046|144507038|SUPERIORITY|||||||0.85|||||||Chi-squared|||||||.85
72489569|NCT03998046|144507040|SUPERIORITY|||||||0.2|||||||t-test, 2 sided|||||||.20
72489570|NCT03998046|144507041|SUPERIORITY|||||||0.38|||||||t-test, 2 sided|||||||.38
72489571|NCT03998046|144507042|SUPERIORITY|||||||0.02|||||||t-test, 2 sided|||||||.02
72489572|NCT03998046|144507043|SUPERIORITY|||||||0.01|||||||t-test, 2 sided|||||||.01
72489573|NCT03998046|144507044|SUPERIORITY|||||||0.13|||||||t-test, 2 sided|||||||.13
72489574|NCT03998046|144507045|SUPERIORITY|||||||0.61|||||||t-test, 2 sided|||||||.61
72489575|NCT03998046|144507046|SUPERIORITY|||||||0.56|||||||Chi-squared|||||||.56
72489576|NCT02354222|144507064|SUPERIORITY||Least Squares Mean Difference|-0.94|STANDARD_ERROR_OF_MEAN|0.11|<|0.001|TWO_SIDED|95.0|-1.16|-0.72|||ANCOVA|||||-0.72|-1.16|<0.001
72489577|NCT02354222|144507065|SUPERIORITY||Least Squares Mean Difference|-15.6|STANDARD_ERROR_OF_MEAN|3.9|<|0.001|TWO_SIDED|95.0|-23.3|-7.9|||ANCOVA|||||-7.9|-23.3|<0.001
72489578|NCT02354222|144507066|SUPERIORITY||Least Squares Mean Difference|1.43|STANDARD_ERROR_OF_MEAN|0.41|<|0.001|TWO_SIDED|95.0|0.63|2.23|||ANCOVA|||||2.23|0.63|<0.001
72489579|NCT02354222|144507067|SUPERIORITY||Least Squares Mean Difference|-55.9|STANDARD_ERROR_OF_MEAN|9.2|<|0.001|TWO_SIDED|95.0|-74.1|-37.6|||ANCOVA|||||-37.6|-74.1|<0.001
72489580|NCT02354222|144507068|SUPERIORITY||Least Squares Mean Difference|-37.6|STANDARD_ERROR_OF_MEAN|6.2|<|0.001|TWO_SIDED|95.0|-49.9|-25.2|||ANCOVA|||||-25.2|-49.9|<0.001
72489581|NCT01342484|144507088|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.48|STANDARD_ERROR_OF_MEAN|0.48||0.3295|TWO_SIDED|95.0|-1.47|0.51|||Mixed Models Analysis|The Kenward-Roger approximation was used to estimate denominator degrees of freedom.|Mean Difference (Net Values) is actually the adjusted mean difference calculated as Linagliptin 1 mg minus Placebo.|Superiority of Linagliptin 1 mg vs. placebo: change from baseline in HbA1c using a restricted maximum likelihood (REML) - based mixed model repeated measures (MMRM) approach. Model includes baseline HbA1c and age as linear covariates; treatment, gender, pharmacokinetic (PK) / pharmacodynamics (PD) subgroup, background therapy, visit and visit by treatment interaction as fixed effects and patient as a random effect. The unstructured covariance structure has been used to fit the mixed model.||0.51|-1.47|0.3295
72489582|NCT01342484|144507088|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.63|STANDARD_ERROR_OF_MEAN|0.42||0.1447|TWO_SIDED|95.0|-1.5|0.23|||Mixed Models Analysis|The Kenward-Roger approximation was used to estimate denominator degrees of freedom.|Mean Difference (Net Values) is actually the adjusted mean difference calculated as Linagliptin 5 mg minus Placebo.|Superiority of Linagliptin 5 mg vs. placebo: change from baseline in HbA1c using a restricted maximum likelihood (REML) - based mixed model repeated measures (MMRM) approach. Model includes baseline HbA1c and age as linear covariates; treatment, gender, PK/PD subgroup, background therapy, visit and visit by treatment interaction as fixed effects and patient as a random effect. The unstructured covariance structure has been used to fit the mixed model.||0.23|-1.50|0.1447
72489583|NCT01342484|144507090|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.31|STANDARD_ERROR_OF_MEAN|1.36||0.8216|TWO_SIDED|95.0|-3.08|2.46|||Mixed Models Analysis|The Kenward-Roger approximation was used to estimate denominator degrees of freedom.|Mean Difference (Net Values) is actually the adjusted mean difference calculated as Linagliptin 1 mg minus Placebo.|Superiority of Linagliptin 1 mg vs. placebo: change from baseline in FPG using a restricted maximum likelihood (REML) - based mixed model repeated measures (MMRM) approach. Model includes baseline HbA1c, baseline FPG and age as linear covariates; treatment, gender, PK/PD subgroup, background therapy, visit and visit by treatment interaction as fixed effects and patient as a random effect. The unstructured covariance structure has been used to fit the mixed model.||2.46|-3.08|0.8216
72404331|NCT02180412|144315424|OTHER||Slope|12.2||||0.9993|TWO_SIDED|95.0|-465.4|489.8|||ANCOVA|||Total Porphyrins Day 1 vs Day 2||489.8|-465.4|.9993
72489584|NCT01342484|144507090|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.9|STANDARD_ERROR_OF_MEAN|1.18||0.1189|TWO_SIDED|95.0|-4.31|0.52|||Mixed Models Analysis|The Kenward-Roger approximation was used to estimate denominator degrees of freedom.|Mean Difference (Net Values) is actually the adjusted mean difference calculated as Linagliptin 5 mg minus Placebo.|Superiority of Linagliptin 5 mg vs. placebo: change from baseline in FPG using a restricted maximum likelihood (REML) - based mixed model repeated measures (MMRM) approach. Model includes baseline HbA1c, baseline FPG and age as linear covariates; treatment, gender, PK/PD subgroup, background therapy, visit and visit by treatment interaction as fixed effects and patient as a random effect. The unstructured covariance structure has been used to fit the mixed model.||0.52|-4.31|0.1189
72489585|NCT02822885|144507150|SUPERIORITY_OR_OTHER||||||<|0.05||||||All included p-values are calculated from collected data and not threshold values for statical significance|t-test, 2 sided|||||||<0.05
72489586|NCT02822885|144507151|SUPERIORITY_OR_OTHER||||||<|0.05||||||All included p-values are calculated from collected data and not threshold values for statical significance|t-test, 2 sided|||||||<0.05
72489587|NCT02822885|144507152|SUPERIORITY_OR_OTHER||||||<|0.05||||||All included p-values are calculated from collected data and not threshold values for statical significance|t-test, 2 sided|||||||<0.05
72489588|NCT02822885|144507153|SUPERIORITY_OR_OTHER||||||<|0.05||||||All included p-values are calculated from collected data and not threshold values for statical significance|t-test, 2 sided|||||||<0.05
72489589|NCT02822885|144507154|SUPERIORITY_OR_OTHER||||||<|0.05||||||All included p-values are calculated from collected data and not threshold values for statical significance|t-test, 2 sided|||||||<0.05
72489590|NCT05248295|144507155|OTHER|Separate regression models were used within each group (People with aphasia and Controls) to independently assess the effects of the variables. Below, the results are reported for the effect of production condition (Unison vs. Solo) for the group of interest, People with aphasia.|Odds Ratio (OR)|1.21|STANDARD_ERROR_OF_MEAN|0.13||0.077|TWO_SIDED|||||Results are reported for production condition for people with aphasia (experimental group).|Regression, Logistic||OR computed with Unison as the numerator and Solo as the denominator|People with aphasia (PWA) were not directly compared to controls since the finding of a lower % syllables correct in any condition in PWA would be trivial. Instead, within-groups analyses were conducted to understand how the experimental variables affected syllable accuracy within each group.||||0.077
72489591|NCT05248295|144507155|OTHER|Below, the results are reported for the effect of timing condition (Metrical vs. Conversational) for the group of interest, People with aphasia.|||||>|0.1||||||Results are reported for Timing Condition for the People with aphasia.|Regression, Logistic|||||||>.1
72489592|NCT05248295|144507155|OTHER|Below, the results are reported for the interaction effect between production condition and timing condition for the group of interest, People with aphasia.|Odds Ratio (OR)|1.55|STANDARD_ERROR_OF_MEAN|0.13|<|0.001|TWO_SIDED||||||Regression, Logistic||OR computed as ((Unison Metrical)/(Unison Conversational)) / ((Solo Metrical)/(Solo Conversational))|||||<0.001
72489593|NCT05248295|144507155|OTHER||Odds Ratio (OR)|0.63|STANDARD_ERROR_OF_MEAN|0.14||0.036|TWO_SIDED|||||Results are reported for Production Condition for the Control group.|Regression, Logistic||OR computed with Unison as the numerator and Solo as the denominator|Separate regression models were used within each group. Here, the results are reported for the Control group.||||0.036
72516227|NCT02505542|144563540|OTHER||||||<|0.001|||||||Log Rank|||P-values were from stratified log-rank test comparing the Certolizumab pegol 200 mg Q2W Double-Blind (RS) group with the Placebo Double-Blind (RS) group (Geographic region and modified New York (mNY) classification were used as stratification factors).||||<0.001
72489594|NCT05248295|144507155|OTHER|Below, the results are reported for the effect of timing condition (Metrical vs. Conversational) for the control group.|Odds Ratio (OR)|3.36|STANDARD_ERROR_OF_MEAN|1.19|<|0.001|TWO_SIDED||||||Regression, Logistic||OR computed with Metrical as the numerator and Conversational as the denominator|||||<0.001
72404332|NCT02180412|144315424|OTHER||Slope|454.5||||0.2915|TWO_SIDED|95.0|-200.87|1109.86|||ANCOVA|||Total Porphyrins Day 1 vs Day 3||1109.86|-200.87|.2915
72489595|NCT05248295|144507155|OTHER|Below, the results are reported for the interaction effect between production condition and timing condition for the control group.|||||>|0.1|||||||Regression, Logistic|||||||>.1
72489596|NCT05248295|144507156|OTHER|Separate regression models were used within each group (People with aphasia and Controls) to independently assess the effects of Timing Condition. Production Condition is not included in the analysis since all timing data are from the unison production condition, by definition.|Slope|-0.14|STANDARD_ERROR_OF_MEAN|0.02|<|0.001|TWO_SIDED|||||Results are reported for people with aphasia (experimental group).|Regression, Linear|||People with aphasia were not directly compared to Controls since the Control group is a context-providing reference group rather than a true comparator. Instead, within-groups analyses were conducted to understand how the experimental variable affected timing alignment in each group.||||<0.001
72489597|NCT05248295|144507156|OTHER||Slope|-0.05|STANDARD_ERROR_OF_MEAN|0.0|<|0.001|TWO_SIDED|||||Results are reported for the Control group.|Regression, Linear|||People with aphasia were not directly compared to Controls since the Control group is a context-providing reference group and not a true comparator. Instead, within-groups analyses were conducted to understand how experimental variables affected timing alignment in each group.||||<0.001
72489598|NCT03021499|144507157|SUPERIORITY||Odds Ratio (OR)|2.65|||<|0.001|TWO_SIDED|95.0|1.64|4.27|||Regression, Logistic|The model is based on a logistic regression with terms for treatment, baseline UPCR, biopsy class, MMF use at baseline and Region.||The primary endpoint was the proportion of subjects showing renal response at Week 52 as adjudicated by the Clinical Endpoints Committee.||4.27|1.64|<0.001
72489599|NCT03021499|144507158|SUPERIORITY||Hazard Ratio (HR)|2.02|||<|0.001|TWO_SIDED|95.0|1.51|2.7|||Log Rank|||||2.7|1.51|<0.001
72489600|NCT03021499|144507160|SUPERIORITY||Odds Ratio (OR)|2.23||||0.002|TWO_SIDED|95.0|1.34|3.72|||Regression, Cox||The hazard ratios are from a Cox's proportional hazards model with terms for treatment arm, baseline UPCR, biopsy class, MMF use at baseline and Region|||3.72|1.34|0.002
72489601|NCT03021499|144507161|SUPERIORITY||Odds Ratio (OR)|2.43|||<|0.001|TWO_SIDED|95.0|1.56|3.79||Week 24|Regression, Logistic||Week 24|Week 24||3.79|1.56|<0.001
72404333|NCT02180412|144315424|OTHER||Slope|326.12||||0.4382|TWO_SIDED|95.0|-292.0|944.25|||ANCOVA|||Total Porphyrins Day 1 vs Day 4||944.25|-292|.4382
72489602|NCT03021499|144507161|SUPERIORITY||Odds Ratio (OR)|2.26|||<|0.001|TWO_SIDED|95.0|1.45|3.51||Week 52|Regression, Logistic||Week 52|Week 52||3.51|1.45|<0.001
72489603|NCT03021499|144507162|SUPERIORITY||Hazard Ratio (HR)|0.81||||0.349|TWO_SIDED|95.0|0.53|1.25|||Regression, Cox|||||1.25|0.53|0.349
72489604|NCT03021499|144507162|SUPERIORITY|||||||0.646|||||||Log Rank|||||||0.646
72489605|NCT03021499|144507165|SUPERIORITY||Hazard Ratio (HR)|2.05|||<|0.001|TWO_SIDED|95.0|1.62|2.6|||Log Rank|||||2.6|1.62|<0.001
72489606|NCT03021499|144507166|SUPERIORITY||Mean Difference (Least Squares)|-4.6|STANDARD_ERROR_OF_MEAN|1.39|<|0.001|TWO_SIDED|95.0|-7.3|-1.9|||Mixed Models Analysis|||Week 2||-1.9|-7.3|< 0.001
72489607|NCT03021499|144507166|SUPERIORITY||Mean Difference (Least Squares)|-3.4|STANDARD_ERROR_OF_MEAN|1.39||0.014|TWO_SIDED|95.0|-6.1|-0.7|||Mixed Models Analysis|||Week 4||-0.7|-6.1|0.014
72516228|NCT02505542|144563540|OTHER||||||<|0.001|||||||Log Rank|||P-values were from stratified log-rank test comparing the Certolizumab pegol 200 mg Q4W Double-Blind (RS) group with the Placebo Double-Blind (RS) group (Geographic region and modified New York (mNY) classification were used as stratification factors).||||<0.001
72516229|NCT02505542|144563542|SUPERIORITY||Odds Ratio (OR)|17.94|||<|0.001|TWO_SIDED|95.0|8.95|35.961|||Regression, Logistic|||Odds ratios (and corresponding p-values) were from a logistic regression model with factors for treatment group, geographical region, and modified New York (mNY) classification.||35.961|8.950|<0.001
72516230|NCT02505542|144563542|SUPERIORITY||Odds Ratio (OR)|11.385|||<|0.001|TWO_SIDED|95.0|5.952|21.778|||Regression, Logistic|||Odds ratios (and corresponding p-values) were from a logistic regression model with factors for treatment group, geographical region, and modified New York (mNY) classification.||21.778|5.952|<0.001
72516231|NCT02505542|144563542|SUPERIORITY||Odds Ratio (OR)|17.653|||<|0.001|TWO_SIDED|95.0|8.333|37.399|||Regression, Logistic|||Odds ratios (and corresponding p-values) were from a logistic regression model with factors for treatment group, geographical region, and modified New York (mNY) classification.||37.399|8.333|<0.001
72404334|NCT02739269|144315428|SUPERIORITY|||||||0.479|||||||Chi-squared|||||||0.479
72404335|NCT02739269|144315429|SUPERIORITY|||||||0.002|||||||Chi-squared|||||||0.002
72489608|NCT03021499|144507166|SUPERIORITY||Mean Difference (Least Squares)|-4.6|STANDARD_ERROR_OF_MEAN|1.39|<|0.001|TWO_SIDED|95.0|-7.3|-1.9|||Mixed Models Analysis|||Week 8||-1.9|-7.3|< 0.001
72516232|NCT02505542|144563542|SUPERIORITY||Odds Ratio (OR)|11.863|||<|0.001|TWO_SIDED|95.0|5.67|24.822|||Regression, Logistic|||Odds ratios (and corresponding p-values) were from a logistic regression model with factors for treatment group, geographical region, and modified New York (mNY) classification.||24.822|5.670|<0.001
72489609|NCT03021499|144507166|SUPERIORITY||Mean Difference (Least Squares)|-3.3|STANDARD_ERROR_OF_MEAN|1.39||0.017|TWO_SIDED|95.0|-6.0|-0.6|||Mixed Models Analysis|||Week 12||-0.6|-6|0.017
72516233|NCT02505542|144563543|SUPERIORITY||Odds Ratio (OR)|20.205|||<|0.001|TWO_SIDED|95.0|9.851|41.439|||Regression, Logistic|||Odds ratios (and corresponding p-values) were from a logistic regression model with factors for treatment group, geographical region, and mNY classification.||41.439|9.851|<0.001
72489610|NCT03021499|144507166|SUPERIORITY||Mean Difference (Least Squares)|-2.4|STANDARD_ERROR_OF_MEAN|1.4||0.085|TWO_SIDED|95.0|-5.1|0.3|||Mixed Models Analysis|||Week 16||0.3|-5.1|0.085
72489611|NCT03021499|144507166|SUPERIORITY||Mean Difference (Least Squares)|-3.0|STANDARD_ERROR_OF_MEAN|1.4||0.035|TWO_SIDED|95.0|-5.7|-0.2|||Mixed Models Analysis|||Week 20||-0.2|-5.7|0.035
72489612|NCT03021499|144507166|SUPERIORITY||Mean Difference (Least Squares)|-2.2|STANDARD_ERROR_OF_MEAN|1.41||0.121|TWO_SIDED|95.0|-5.0|0.6|||Mixed Models Analysis|||Week 24||0.6|-5|0.121
72489613|NCT03021499|144507166|SUPERIORITY||Mean Difference (Least Squares)|-2.2|STANDARD_ERROR_OF_MEAN|1.42||0.12|TWO_SIDED|95.0|-5.0|0.6|||Mixed Models Analysis|||Week 30||0.6|-5|0.12
72489614|NCT03021499|144507166|SUPERIORITY||Mean Difference (Least Squares)|-2.3|STANDARD_ERROR_OF_MEAN|1.43||0.102|TWO_SIDED|95.0|-5.1|0.5|||Mixed Models Analysis|||Week 36||0.5|-5.1|0.102
72489615|NCT03021499|144507166|SUPERIORITY||Mean Difference (Least Squares)|-3.3|STANDARD_ERROR_OF_MEAN|1.44||0.022|TWO_SIDED|95.0|-6.1|0.5|||Mixed Models Analysis|||Week 42||0.5|-6.1|0.022
72489616|NCT03021499|144507166|SUPERIORITY||Mean Difference (Least Squares)|-4.1|STANDARD_ERROR_OF_MEAN|1.45||0.004|TWO_SIDED|95.0|-7.0|-1.3|||Mixed Models Analysis|||Week 48||-1.3|-7|0.004
72489617|NCT03021499|144507166|SUPERIORITY||Mean Difference (Least Squares)|-2.8|STANDARD_ERROR_OF_MEAN|1.46||0.055|TWO_SIDED|95.0|-5.7|0.1|||Mixed Models Analysis|||Week 52||0.1|-5.7|0.055
72489618|NCT03021499|144507167|SUPERIORITY||Mean Difference (Least Squares)|-0.56|STANDARD_ERROR_OF_MEAN|0.181||0.011|TWO_SIDED|95.0|-1.0|-0.13|||Mixed Models Analysis|||Week 2||-0.13|-1|0.011
72489619|NCT03021499|144507167|SUPERIORITY||Mean Difference (Least Squares)|-0.76|STANDARD_ERROR_OF_MEAN|0.187|<|0.001|TWO_SIDED|95.0|-1.13|-0.4|||Mixed Models Analysis|||Week 4||-0.4|-1.13|<0.001
72516234|NCT02505542|144563543|SUPERIORITY||Odds Ratio (OR)|12.07|||<|0.001|TWO_SIDED|95.0|6.275|23.218|||Regression, Logistic|||Odds ratios (and corresponding p-values) were from a logistic regression model with factors for treatment group, geographical region, and mNY classification.||23.218|6.275|<0.001
72516235|NCT02505542|144563544|SUPERIORITY||Odds Ratio (OR)|20.891|||<|0.001|TWO_SIDED|95.0|10.21|42.744|||Regression, Logistic|||Odds ratios (and corresponding p-values) were from a logistic regression model with factors for treatment group, geographical region, and mNY classification.||42.744|10.210|<0.001
72516236|NCT02505542|144563544|SUPERIORITY||Odds Ratio (OR)|10.377|||<|0.001|TWO_SIDED|95.0|5.456|19.738|||Regression, Logistic|||Odds ratios (and corresponding p-values) were from a logistic regression model with factors for treatment group, geographical region, and mNY classification.||19.738|5.456|<0.001
72516237|NCT02505542|144563545|SUPERIORITY||Odds Ratio (OR)|16.9|||<|0.001|TWO_SIDED|95.0|8.211|34.785|||Regression, Logistic|||Odds ratios (and corresponding p-values) were from a logistic regression model with factors for treatment group, geographical region, and mNY classification.||34.785|8.211|<0.001
72489620|NCT03021499|144507167|SUPERIORITY||Mean Difference (Least Squares)|-0.7|STANDARD_ERROR_OF_MEAN|0.181|<|0.001|TWO_SIDED|95.0|-1.05|-0.34|||Mixed Models Analysis|||Week 8||-0.34|-1.05|<0.001
72489621|NCT03021499|144507167|SUPERIORITY||Mean Difference (Least Squares)|-0.94|STANDARD_ERROR_OF_MEAN|0.196|<|0.001|TWO_SIDED|95.0|-1.33|-0.55|||Mixed Models Analysis|||Week 12||-0.55|-1.33|<0.001
72489622|NCT03021499|144507167|SUPERIORITY||Mean Difference (Least Squares)|-1.18|STANDARD_ERROR_OF_MEAN|0.214|<|0.001|TWO_SIDED|95.0|-1.6|-0.76|||Mixed Models Analysis|||Week 16||-0.76|-1.6|<0.001
72489623|NCT03021499|144507167|SUPERIORITY||Mean Difference (Least Squares)|-1.16|STANDARD_ERROR_OF_MEAN|0.241|<|0.001|TWO_SIDED|95.0|-1.63|-0.68|||Mixed Models Analysis|||Week 20||-0.68|-1.63|<0.001
72489624|NCT03021499|144507167|SUPERIORITY||Mean Difference (Least Squares)|-1.15|STANDARD_ERROR_OF_MEAN|0.222|<|0.001|TWO_SIDED|95.0|-1.59|-0.72|||Mixed Models Analysis|||Week 24||-0.72|-1.59|<0.001
72489625|NCT03021499|144507167|SUPERIORITY||Mean Difference (Least Squares)|-1.02|STANDARD_ERROR_OF_MEAN|0.284|<|0.001|TWO_SIDED|95.0|-1.58|-0.46|||Mixed Models Analysis|||Week 30||-0.46|-1.58|<0.001
72489626|NCT03021499|144507167|SUPERIORITY||Mean Difference (Least Squares)|-1.21|STANDARD_ERROR_OF_MEAN|0.264|<|0.001|TWO_SIDED|95.0|-1.73|-0.69|||Mixed Models Analysis|||Week 36||-0.69|-1.73|<0.001
72489627|NCT03021499|144507167|SUPERIORITY||Mean Difference (Least Squares)|-1.37|STANDARD_ERROR_OF_MEAN|0.256|<|0.001|TWO_SIDED|95.0|-1.87|-0.86|||Mixed Models Analysis|||Week 42||-0.86|-1.87|<0.001
72489628|NCT03021499|144507167|SUPERIORITY||Mean Difference (Least Squares)|-1.06|STANDARD_ERROR_OF_MEAN|0.256|<|0.001|TWO_SIDED|95.0|-1.56|-0.55|||Mixed Models Analysis|||Week 48||-0.55|-1.56|<0.001
72489629|NCT03021499|144507167|SUPERIORITY||Mean Difference (Least Squares)|-0.99|STANDARD_ERROR_OF_MEAN|0.27|<|0.001|TWO_SIDED|95.0|-1.52|-0.46|||Mixed Models Analysis|||Week 52||-0.46|-1.52|<0.001
72489630|NCT03021499|144507168|SUPERIORITY||Odds Ratio (OR)|2.44||||0.008|TWO_SIDED|95.0|1.26|4.71||Week 24|Regression, Logistic||Week 24|Week 24||4.71|1.26|0.008
72516238|NCT02505542|144563545|SUPERIORITY||Odds Ratio (OR)|12.072|||<|0.001|TWO_SIDED|95.0|5.954|24.476|||Regression, Logistic|||Odds ratios (and corresponding p-values) were from a logistic regression model with factors for treatment group, geographical region, and mNY classification.||24.476|5.954|<0.001
72489631|NCT03021499|144507168|SUPERIORITY||Odds Ratio (OR)|2.44|||<|0.001|TWO_SIDED|95.0|1.48|4.0||Week 52|Regression, Logistic||Week 52|Week 52||4.00|1.48|<0.001
72489632|NCT03021499|144507169|SUPERIORITY||Least Squares Mean difference|-0.5||||0.373|TWO_SIDED|95.0|-1.6|0.6||Week 24|Mixed Models Analysis||Week 24|Week 24||0.6|-1.6|0.373
72489633|NCT03021499|144507169|SUPERIORITY||Least Squares Mean difference|-0.5||||0.277|TWO_SIDED|95.0|-1.4|0.4||Week 52|Mixed Models Analysis||Week 52|Week 52||0.4|-1.4|0.277
72489634|NCT03021499|144507170|SUPERIORITY||Slope|-0.47|STANDARD_ERROR_OF_MEAN|1.389||0.733|TWO_SIDED|95.0|-3.21|2.26|||Mixed Models Analysis|||SF-36 Change from Baseline Week 24||2.26|-3.21|0.733
72489635|NCT03021499|144507170|SUPERIORITY||Mean Difference (Least Squares)|-0.37|STANDARD_ERROR_OF_MEAN|1.481||0.801|TWO_SIDED|95.0|-3.29|2.54|||Mixed Models Analysis|||SF-36 Change from Baseline at Week 52||2.54|-3.29|0.801
72489636|NCT03021499|144507170|SUPERIORITY||Mean Difference (Least Squares)|1.7|STANDARD_ERROR_OF_MEAN|1.442||0.239|TWO_SIDED|95.0|-1.14|4.54|||Mixed Models Analysis|||LupusPRO HRQOL Change from Baseline at Week 24||4.54|-1.14|0.239
72489637|NCT03021499|144507170|SUPERIORITY||Mean Difference (Least Squares)|-0.6|STANDARD_ERROR_OF_MEAN|1.535||0.695|TWO_SIDED|95.0|-3.62|2.42|||Mixed Models Analysis|||LupusPRO HRQOL Change from Baseline at Week 52||2.42|-3.62|0.695
72489638|NCT03021499|144507170|SUPERIORITY||Mean Difference (Least Squares)|-1.89|STANDARD_ERROR_OF_MEAN|1.439||0.19|TWO_SIDED|95.0|-4.72|0.94|||Mixed Models Analysis|||LupusPRO non-HRQOL Change from Baseline at Week 24||0.94|-4.72|0.19
72489639|NCT03021499|144507170|SUPERIORITY||Mean Difference (Least Squares)|0.826|STANDARD_ERROR_OF_MEAN|1.531||0.826|TWO_SIDED|95.0|-2.67|3.35|||Mixed Models Analysis|||LupusPRO non-HRQOL Change from Baseline at Week 52||3.35|-2.67|0.826
72489640|NCT04869345|144507210|SUPERIORITY||Odds Ratio (OR)|0.67||||0.684|TWO_SIDED|95.0|0.13|3.05||A priori threshold for statistical significance = 0.05.|Boschloo Test||Maximum likelihood estimate of the Odds Ratio comparing retention rate in LARKSPUR group to Attention Control group|||3.05|0.13|.684
72489641|NCT04869345|144507213|SUPERIORITY||Mean Difference (Final Values)|-0.27|STANDARD_ERROR_OF_MEAN|1.28||0.835|TWO_SIDED|95.0|-2.8|2.27||The threshold for statistical significance was 0.05.|Mixed Models Analysis|P-value adjusted using the Kenward-Roger (1997) degrees of freedom method.|The estimated Mean Difference compares the LARKSPUR intervention minus the Attention Control.|The treatment difference (LARKSPUR Intervention vs. Attention Control) at Week 11 (Post-Intervention) was tested using a mixed effects model with two treatment groups and two time points (Week 11, Week 16) and their interaction adjusting for baseline PROMIS Pain Intensity scores. Sample size was chosen based on feasibility indicators (recruitment, retention, adherence) rather than on formal power analyses.||2.27|-2.80|0.835
72489642|NCT04869345|144507213|SUPERIORITY||Mean Difference (Final Values)|0.44|STANDARD_ERROR_OF_MEAN|1.29||0.732|TWO_SIDED|95.0|-2.12|3.0||The threshold for statistical significance was 0.05.|Mixed Models Analysis|Degrees of freedom and standard error estimates were adjusted using the Kenward-Roger (1997) method.|The estimated Mean Difference compares the LARKSPUR intervention minus the Attention Control.|The treatment difference (LARKSPUR Intervention vs. Attention Control) at Week 16 (1 Month Post-Intervention) was tested using a mixed effects model with two treatment groups and two time points (Week 11, Week 16) and their interaction adjusting for baseline PROMIS Pain Intensity scores. Sample size was chosen based on feasibility indicators (recruitment, retention, adherence) rather than on formal power analyses.||3.00|-2.12|0.732
72516239|NCT02505542|144563546|SUPERIORITY||Odds Ratio (OR)|17.082|||<|0.001|TWO_SIDED|95.0|8.561|34.085|||Regression, Logistic|||Odds ratios (and corresponding p-values) were from a logistic regression model with factors for treatment group, geographical region, and mNY classification.||34.085|8.561|<0.001
72516240|NCT02505542|144563546|SUPERIORITY||Odds Ratio (OR)|11.503|||<|0.001|TWO_SIDED|95.0|5.939|22.278|||Regression, Logistic|||Odds ratios (and corresponding p-values) were from a logistic regression model with factors for treatment group, geographical region, and mNY classification.||22.278|5.939|<0.001
72404336|NCT00405548|144315434|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||t-test, 2 sided|||||||<0.001
72404337|NCT00405548|144315435|SUPERIORITY_OR_OTHER|||||||0.05|TWO_SIDED||||||t-test, 2 sided|||||||0.05
72489643|NCT04869345|144507213|SUPERIORITY||Mean Difference (Net)|0.71|STANDARD_ERROR_OF_MEAN|1.38||0.609|TWO_SIDED|95.0|-2.05|3.47||The threshold for statistical significance was 0.05.|Mixed Models Analysis|Degrees of freedom and standard error estimates were adjusted using the Kenward-Roger (1997) method.|The estimated Mean Difference (Net) compares the change for the LARKSPUR intervention (Week 16 minus Week 11) minus the change for the Attention Control (Week 16 minus Week 11).|The treatment difference (LARKSPUR Intervention vs. Attention Control) in change from Week 11 (Post-Intervention) to Week 16 (1 Month Post-Intervention) was tested using a mixed effects model with two treatment groups and two time points (Week 11, Week 16) and their interaction adjusting for baseline PROMIS Pain Intensity scores. Sample size was chosen based on feasibility indicators (recruitment, retention, adherence) rather than on formal power analyses.||3.47|-2.05|0.609
72516241|NCT02505542|144563547|OTHER||LS Mean Difference vs Placebo|-1.42|STANDARD_ERROR_OF_MEAN|0.126|<|0.001|TWO_SIDED|95.0|-1.66|-1.17|||Mixed Models Analysis|||An mixed model with repeated measures (MMRM) analysis on all observed post-baseline data with the following fixed-effect covariates was used: treatment, geographical region, mNY classification, Part B Baseline value, and visit as fixed-effect factors, as well as treatment group by visit interaction and Part B Baseline value by visit interaction.||-1.17|-1.66|<0.001
72516242|NCT02505542|144563547|OTHER||LS Mean Difference vs Placebo|-1.21|STANDARD_ERROR_OF_MEAN|0.126|<|0.001|TWO_SIDED|95.0|-1.45|-0.96|||Mixed Models Analysis|||An mixed model with repeated measures (MMRM) analysis on all observed post-baseline data with the following fixed-effect covariates was used: treatment, geographical region, mNY classification, Part B Baseline value, and visit as fixed-effect factors, as well as treatment group by visit interaction and Part B Baseline value by visit interaction.||-0.96|-1.45|<0.001
72516243|NCT02505542|144563548|OTHER||LS Mean Difference vs Placebo|-2.46|STANDARD_ERROR_OF_MEAN|0.268|<|0.001|TWO_SIDED|95.0|-2.99|-1.94|||Mixed Models Analysis|||An mixed model with repeated measures (MMRM) analysis on all observed post-baseline data with the following fixed-effect covariates was used: treatment, geographical region, mNY classification, Part B Baseline value, and visit as fixed-effect factors, as well as treatment group by visit interaction and Part B Baseline value by visit interaction.||-1.94|-2.99|<0.001
72516244|NCT02505542|144563548|OTHER||LS Mean Difference vs Placebo|-2.24|STANDARD_ERROR_OF_MEAN|0.267|<|0.001|TWO_SIDED|95.0|-2.77|-1.72|||Mixed Models Analysis|||An mixed model with repeated measures (MMRM) analysis on all observed post-baseline data with the following fixed-effect covariates was used: treatment, geographical region, mNY classification, Part B Baseline value, and visit as fixed-effect factors, as well as treatment group by visit interaction and Part B Baseline value by visit interaction.||-1.72|-2.77|<0.001
72516245|NCT02505542|144563549|OTHER||LS Mean Difference vs Placebo|-1.57|STANDARD_ERROR_OF_MEAN|0.238|<|0.001|TWO_SIDED|95.0|-2.04|-1.11|||Mixed Models Analysis|||An mixed model with repeated measures (MMRM) analysis on all observed post-baseline data with the following fixed-effect covariates was used: treatment, geographical region, mNY classification, Part B Baseline value, and visit as fixed-effect factors, as well as treatment group by visit interaction and Part B Baseline value by visit interaction.||-1.11|-2.04|<0.001
72516246|NCT02505542|144563549|OTHER||LS Mean Difference vs Placebo|-1.43|STANDARD_ERROR_OF_MEAN|0.238|<|0.001|TWO_SIDED|95.0|-1.9|-0.96|||Mixed Models Analysis|||An mixed model with repeated measures (MMRM) analysis on all observed post-baseline data with the following fixed-effect covariates was used: treatment, geographical region, mNY classification, Part B Baseline value, and visit as fixed-effect factors, as well as treatment group by visit interaction and Part B Baseline value by visit interaction.||-0.96|-1.90|<0.001
72516247|NCT02505542|144563550|OTHER||LS Mean Difference vs Placebo|-0.2|STANDARD_ERROR_OF_MEAN|0.112|=|0.074|TWO_SIDED|95.0|-0.42|0.02|||Mixed Models Analysis|||An mixed model with repeated measures (MMRM) analysis on all observed post-baseline data with the following fixed-effect covariates was used: treatment, geographical region, mNY classification, Part B Baseline value, and visit as fixed-effect factors, as well as treatment group by visit interaction and Part B Baseline value by visit interaction.||0.02|-0.42|=0.074
72404338|NCT00405548|144315436|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||t-test, 2 sided|||||||<0.001
72404339|NCT00405548|144315437|SUPERIORITY_OR_OTHER|||||||0.004||95.0|||||t-test, 2 sided|A p-value of less 0.05 was considered to be statistically significant.||Mean LV filling pressure was compared from baseline to 12 weeks within the BNP group.||||0.004
72404340|NCT00405548|144315437|SUPERIORITY_OR_OTHER|||||||0.43||95.0|||||t-test, 2 sided|A p-value of less 0.05 was considered to be statistically significant.||Mean LV filling pressure was compared from baseline to 12 weeks within the Placebo group.||||0.43
72404341|NCT00680901|144315448|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.91||||0.3492|TWO_SIDED|95.0|0.73|1.12||Stratified log-rank test was conducted stratifying for prior adjuvant/neo-adjuvant treatment use and region.|Log Rank||Pike estimator of HR was based on the stratified log rank test.|Primary Analysis: OS (PE population)||1.12|0.73|0.3492
72516248|NCT02505542|144563550|OTHER||LS Mean Difference vs Placebo|-0.24|STANDARD_ERROR_OF_MEAN|0.113|=|0.036|TWO_SIDED|95.0|-0.46|-0.02|||Mixed Models Analysis|||An mixed model with repeated measures (MMRM) analysis on all observed post-baseline data with the following fixed-effect covariates was used: treatment, geographical region, mNY classification, Part B Baseline value, and visit as fixed-effect factors, as well as treatment group by visit interaction and Part B Baseline value by visit interaction.||-0.02|-0.46|=0.036
72516249|NCT02505542|144563551|SUPERIORITY||Odds Ratio (OR)|18.308|||<|0.001|TWO_SIDED|95.0|9.084|36.898|||Regression, Logistic|||Odds ratios (and corresponding p-values) were from a logistic regression model with factors for treatment group, geographical region, and mNY classification.||36.898|9.084|<0.001
72516250|NCT02505542|144563551|SUPERIORITY||Odds Ratio (OR)|12.02|||<|0.001|TWO_SIDED|95.0|6.255|23.098|||Regression, Logistic|||Odds ratios (and corresponding p-values) were from a logistic regression model with factors for treatment group, geographical region, and mNY classification.||23.098|6.255|<0.001
72489644|NCT04869345|144507214|SUPERIORITY||Mean Difference (Final Values)|-0.83|STANDARD_ERROR_OF_MEAN|1.08||0.445|TWO_SIDED|95.0|-2.97|1.31||The threshold for statistical significance was 0.05.|Mixed Models Analysis|Degrees of freedom and standard error estimates were adjusted using the Kenward-Roger (1997) method.|The estimated Mean Difference compares the LARKSPUR intervention minus the Attention Control.|The treatment difference (LARKSPUR Intervention vs. Attention Control) at Week 11 (Post-Intervention) was tested using a mixed effects model with two treatment groups and two time points (Week 11, Week 16) and their interaction adjusting for baseline PROMIS Pain Interference scores. Sample size was chosen based on feasibility indicators (recruitment, retention, adherence) rather than on formal power analyses.||1.31|-2.97|0.445
72489645|NCT04869345|144507214|SUPERIORITY||Mean Difference (Final Values)|1.38|STANDARD_ERROR_OF_MEAN|1.09||0.209|TWO_SIDED|95.0|-0.78|3.54||The threshold for statistical significance was 0.05.|Mixed Models Analysis|Degrees of freedom and standard error estimates were adjusted using the Kenward-Roger (1997) method.|The estimated Mean Difference compares the LARKSPUR intervention minus the Attention Control.|The treatment difference (LARKSPUR Intervention vs. Attention Control) at Week 16 (1 Month Post-Intervention) was tested using a mixed effects model with two treatment groups and two time points (Week 11, Week 16) and their interaction adjusting for baseline PROMIS Pain Interference scores. Sample size was chosen based on feasibility indicators (recruitment, retention, adherence) rather than on formal power analyses.||3.54|-0.78|0.209
72489646|NCT04869345|144507214|SUPERIORITY||Mean Difference (Net)|2.21|STANDARD_ERROR_OF_MEAN|1.17||0.063|TWO_SIDED|95.0|-0.12|4.54||The threshold for statistical significance was 0.05.|Mixed Models Analysis|Degrees of freedom and standard error estimates were adjusted using the Kenward-Roger (1997) method.|The estimated Mean Difference (Net) compares the change for the LARKSPUR intervention (Week 16 minus Week 11) minus the change for the Attention Control (Week 16 minus Week 11).|The treatment difference (LARKSPUR Intervention vs. Attention Control) in change from Week 11 (Post-Intervention) to Week 16 (1 Month Post-Intervention) was tested using a mixed effects model with two treatment groups and two time points (Week 11, Week 16) and their interaction adjusting for baseline PROMIS Pain Interference scores. Sample size was chosen based on feasibility indicators (recruitment, retention, adherence) rather than on formal power analyses.||4.54|-0.12|0.063
72489647|NCT04869345|144507215|SUPERIORITY||Mean Difference (Final Values)|0.25|STANDARD_ERROR_OF_MEAN|0.95||0.792|TWO_SIDED|95.0|-1.63|2.13||The threshold for statistical significance was 0.05.|Mixed Models Analysis|Degrees of freedom and standard error estimates were adjusted using the Kenward-Roger (1997) method.|The estimated Mean Difference compares the LARKSPUR intervention minus the Attention Control.|The treatment difference (LARKSPUR Intervention vs. Attention Control) at Week 11 (Post-Intervention) was tested using a mixed effects model with two treatment groups and two time points (Week 11, Week 16) and their interaction adjusting for baseline PROMIS Physical Functioning scores. Sample size was chosen based on feasibility indicators (recruitment, retention, adherence) rather than on formal power analyses.||2.13|-1.63|0.792
72489648|NCT04869345|144507215|SUPERIORITY||Mean Difference (Final Values)|1.2|STANDARD_ERROR_OF_MEAN|0.95||0.209|TWO_SIDED|95.0|-0.69|3.09||The threshold for statistical significance was 0.05.|Mixed Models Analysis|Degrees of freedom and standard error estimates were adjusted using the Kenward-Roger (1997) method.|The estimated Mean Difference compares the LARKSPUR intervention minus the Attention Control.|The treatment difference (LARKSPUR Intervention vs. Attention Control) at Week 16 (1 Month Post-Intervention) was tested using a mixed effects model with two treatment groups and two time points (Week 11, Week 16) and their interaction adjusting for baseline PROMIS Physical Functioning scores. Sample size was chosen based on feasibility indicators (recruitment, retention, adherence) rather than on formal power analyses.||3.09|-0.69|0.209
72489649|NCT04869345|144507215|SUPERIORITY||Mean Difference (Net)|0.95|STANDARD_ERROR_OF_MEAN|0.66||0.151|TWO_SIDED|95.0|-0.35|2.26||The threshold for statistical significance was 0.05.|Mixed Models Analysis|Degrees of freedom and standard error estimates were adjusted using the Kenward-Roger (1997) method.|The estimated Mean Difference (Net) compares the change for the LARKSPUR intervention (Week 16 minus Week 11) minus the change for the Attention Control (Week 16 minus Week 11).|The treatment difference (LARKSPUR Intervention vs. Attention Control) in change from Week 11 (Post-Intervention) to Week 16 (1 Month Post-Intervention) was tested using a mixed effects model with two treatment groups and two time points (Week 11, Week 16) and their interaction adjusting for baseline PROMIS Pain Intensity scores. Sample size was chosen based on feasibility indicators (recruitment, retention, adherence) rather than on formal power analyses.||2.26|-0.35|0.151
72489650|NCT04869345|144507216|SUPERIORITY||Mean Difference (Final Values)|0.77|STANDARD_ERROR_OF_MEAN|1.47||0.601|TWO_SIDED|95.0|-2.14|3.69||The threshold for statistical significance was 0.05.|Mixed Models Analysis|Degrees of freedom and standard error estimates were adjusted using the Kenward-Roger (1997) method.|The estimated Mean Difference compares the LARKSPUR intervention minus the Attention Control.|The treatment difference (LARKSPUR Intervention vs. Attention Control) at Week 11 (Post-Intervention) was tested using a mixed effects model with two treatment groups and two time points (Week 11, Week 16) and their interaction adjusting for baseline PROMIS Fatigue scores. Sample size was chosen based on feasibility indicators (recruitment, retention, adherence) rather than on formal power analyses.||3.69|-2.14|0.601
72516251|NCT02505542|144563552|OTHER||LS Mean Difference vs Placebo|-1.0|STANDARD_ERROR_OF_MEAN|0.76|=|0.195|TWO_SIDED|95.0|-2.5|0.51|||ANCOVA|||"Only MRIs performed ± 2 weeks around the Week 96 or Early Withdrawal Visit were assigned to Week 96 or Early Withdrawal.~Only results of the double-read assessments of the central MRI review were included. The analysis used the average of the scores from the 2 independent reviewers. Whenever an adjudication was present, the average score across all 3 reviewers was used.~ANCOVA model with treatment, geographical region, mNY classification, and Part B Baseline as covariates."||0.51|-2.50|=0.195
72489651|NCT04869345|144507216|SUPERIORITY||Mean Difference (Final Values)|-1.65|STANDARD_ERROR_OF_MEAN|1.49||0.269|TWO_SIDED|95.0|-4.6|1.29||The threshold for statistical significance was 0.05.|Mixed Models Analysis|Degrees of freedom and standard error estimates were adjusted using the Kenward-Roger (1997) method.|The estimated Mean Difference compares the LARKSPUR intervention minus the Attention Control.|The treatment difference (LARKSPUR Intervention vs. Attention Control) at Week 16 (1 Month Post-Intervention) was tested using a mixed effects model with two treatment groups and two time points (Week 11, Week 16) and their interaction adjusting for baseline PROMIS Fatigue scores. Sample size was chosen based on feasibility indicators (recruitment, retention, adherence) rather than on formal power analyses.||1.29|-4.60|0.269
72489652|NCT04869345|144507216|SUPERIORITY||Mean Difference (Net)|-2.43|STANDARD_ERROR_OF_MEAN|1.53||0.116|TWO_SIDED|95.0|-5.47|0.61||The threshold for statistical significance was 0.05.|Mixed Models Analysis|Degrees of freedom and standard error estimates were adjusted using the Kenward-Roger (1997) method.|The estimated Mean Difference (Net) compares the change for the LARKSPUR intervention (Week 16 minus Week 11) minus the change for the Attention Control (Week 16 minus Week 11).|The treatment difference (LARKSPUR Intervention vs. Attention Control) in change from Week 11 (Post-Intervention) to Week 16 (1 Month Post-Intervention) was tested using a mixed effects model with two treatment groups and two time points (Week 11, Week 16) and their interaction adjusting for baseline PROMIS Fatigue scores. Sample size was chosen based on feasibility indicators (recruitment, retention, adherence) rather than on formal power analyses.||0.61|-5.47|0.116
72489653|NCT04869345|144507217|SUPERIORITY||Mean Difference (Final Values)|0.06|STANDARD_ERROR_OF_MEAN|0.08||0.479|TWO_SIDED|95.0|-0.1|0.22||The threshold for statistical significance was 0.05.|Mixed Models Analysis|Degrees of freedom and standard error estimates were adjusted using the Kenward-Roger (1997) method.|The estimated Mean Difference compares the LARKSPUR intervention minus the Attention Control.|The treatment difference (LARKSPUR Intervention vs. Attention Control) at Week 11 (Post-Intervention) was tested using a mixed effects model with two treatment groups and two time points (Week 11, Week 16) and their interaction adjusting for baseline CESD-R-10 scores. Sample size was chosen based on feasibility indicators (recruitment, retention, adherence) rather than on formal power analyses.||0.22|-0.10|0.479
72489654|NCT04869345|144507217|SUPERIORITY||Mean Difference (Final Values)|0.13|STANDARD_ERROR_OF_MEAN|0.08||0.126|TWO_SIDED|95.0|-0.04|0.29||The threshold for statistical significance was 0.05.|Mixed Models Analysis|Degrees of freedom and standard error estimates were adjusted using the Kenward-Roger (1997) method.|The estimated Mean Difference compares the LARKSPUR intervention minus the Attention Control.|The treatment difference (LARKSPUR Intervention vs. Attention Control) at Week 16 (1 Month Post-Intervention) was tested using a mixed effects model with two treatment groups and two time points (Week 11, Week 16) and their interaction adjusting for baseline CESD-R-10 scores. Sample size was chosen based on feasibility indicators (recruitment, retention, adherence) rather than on formal power analyses.||0.29|-0.04|0.126
72489655|NCT04869345|144507217|SUPERIORITY||Mean Difference (Net)|0.07|STANDARD_ERROR_OF_MEAN|0.09||0.457|TWO_SIDED|95.0|-0.12|0.25||The threshold for statistical significance was 0.05.|Mixed Models Analysis|Degrees of freedom and standard error estimates were adjusted using the Kenward-Roger (1997) method.|The estimated Mean Difference (Net) compares the change for the LARKSPUR intervention (Week 16 minus Week 11) minus the change for the Attention Control (Week 16 minus Week 11).|The treatment difference (LARKSPUR Intervention vs. Attention Control) in change from Week 11 (Post-Intervention) to Week 16 (1 Month Post-Intervention) was tested using a mixed effects model with two treatment groups and two time points (Week 11, Week 16) and their interaction adjusting for baseline CESD-R-10 scores. Sample size was chosen based on feasibility indicators (recruitment, retention, adherence) rather than on formal power analyses.||0.25|-0.12|0.457
72489656|NCT04869345|144507218|SUPERIORITY||Mean Difference (Final Values)|0.12|STANDARD_ERROR_OF_MEAN|0.13||0.389|TWO_SIDED|95.0|-0.15|0.38||The threshold for statistical significance was 0.05.|Mixed Models Analysis|Degrees of freedom and standard error estimates were adjusted using the Kenward-Roger (1997) method.|The estimated Mean Difference compares the LARKSPUR intervention minus the Attention Control.|The treatment difference (LARKSPUR Intervention vs. Attention Control) at Week 11 (Post-Intervention) was tested using a mixed effects model with two treatment groups and two time points (Week 11, Week 16) and their interaction adjusting for baseline mDES scores. Sample size was chosen based on feasibility indicators (recruitment, retention, adherence) rather than on formal power analyses.||0.38|-0.15|0.389
72404342|NCT00680901|144315449|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.91||||0.3244|TWO_SIDED|95.0|0.74|1.1||Stratified log-rank test was conducted stratifying for prior adjuvant/neo-adjuvant treatment use and region.|Log Rank||Pike estimator of HR was based on the stratified log rank test.|Primary Analysis: OS (ITT population)||1.10|0.74|0.3244
72489657|NCT04869345|144507218|SUPERIORITY||Mean Difference (Final Values)|0.19|STANDARD_ERROR_OF_MEAN|0.13||0.157|TWO_SIDED|95.0|-0.07|0.46||The threshold for statistical significance was 0.05.|Mixed Models Analysis|Degrees of freedom and standard error estimates were adjusted using the Kenward-Roger (1997) method.|The estimated Mean Difference compares the LARKSPUR intervention minus the Attention Control.|The treatment difference (LARKSPUR Intervention vs. Attention Control) at Week 16 (1 Month Post-Intervention) was tested using a mixed effects model with two treatment groups and two time points (Week 11, Week 16) and their interaction adjusting for baseline mDES scores. Sample size was chosen based on feasibility indicators (recruitment, retention, adherence) rather than on formal power analyses.||0.46|-0.07|0.157
72624377|NCT00863304|144778631|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.25|STANDARD_ERROR_OF_MEAN|0.08||0.003|TWO_SIDED|95.0|-0.41|-0.08||P-value was based on pairwise comparisons.|ANCOVA|||Week 12: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.08|-0.41|0.003
72624378|NCT00863304|144778631|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.08||0.069|TWO_SIDED|95.0|-0.32|0.01||P-value was based on pairwise comparisons.|ANCOVA|||Week 12: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||0.01|-0.32|0.069
72489658|NCT04869345|144507218|SUPERIORITY||Mean Difference (Net)|0.08|STANDARD_ERROR_OF_MEAN|0.14||0.593|TWO_SIDED|95.0|-0.21|0.36||The threshold for statistical significance was 0.05.|Mixed Models Analysis|Degrees of freedom and standard error estimates were adjusted using the Kenward-Roger (1997) method.|The estimated Mean Difference (Net) compares the change for the LARKSPUR intervention (Week 16 minus Week 11) minus the change for the Attention Control (Week 16 minus Week 11).|The treatment difference (LARKSPUR Intervention vs. Attention Control) in change from Week 11 (Post-Intervention) to Week 16 (1 Month Post-Intervention) was tested using a mixed effects model with two treatment groups and two time points (Week 11, Week 16) and their interaction adjusting for baseline mDES scores. Sample size was chosen based on feasibility indicators (recruitment, retention, adherence) rather than on formal power analyses.||0.36|-0.21|0.593
72489659|NCT04869345|144507219|SUPERIORITY||Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.13||0.933|TWO_SIDED|95.0|-0.26|0.24||The threshold for statistical significance was 0.05.|Mixed Models Analysis|Degrees of freedom and standard error estimates were adjusted using the Kenward-Roger (1997) method.|The estimated Mean Difference compares the LARKSPUR intervention minus the Attention Control.|The treatment difference (LARKSPUR Intervention vs. Attention Control) at Week 11 (Post-Intervention) was tested using a mixed effects model with two treatment groups and two time points (Week 11, Week 16) and their interaction adjusting for baseline PANAS-GEN scores. Sample size was chosen based on feasibility indicators (recruitment, retention, adherence) rather than on formal power analyses.||0.24|-0.26|0.933
72489660|NCT04869345|144507219|SUPERIORITY||Mean Difference (Final Values)|0.06|STANDARD_ERROR_OF_MEAN|0.13||0.642|TWO_SIDED|95.0|-0.19|0.31||The threshold for statistical significance was 0.05.|Mixed Models Analysis|Degrees of freedom and standard error estimates were adjusted using the Kenward-Roger (1997) method.|The estimated Mean Difference compares the LARKSPUR intervention minus the Attention Control.|The treatment difference (LARKSPUR Intervention vs. Attention Control) at Week 16 (1 Month Post-Intervention) was tested using a mixed effects model with two treatment groups and two time points (Week 11, Week 16) and their interaction adjusting for baseline PANAS-GEN scores. Sample size was chosen based on feasibility indicators (recruitment, retention, adherence) rather than on formal power analyses.||0.31|-0.19|0.642
72489661|NCT04869345|144507219|SUPERIORITY||Mean Difference (Net)|0.07|STANDARD_ERROR_OF_MEAN|0.12||0.577|TWO_SIDED|95.0|-0.18|0.32||The threshold for statistical significance was 0.05.|Mixed Models Analysis|Degrees of freedom and standard error estimates were adjusted using the Kenward-Roger (1997) method.|The estimated Mean Difference (Net) compares the change for the LARKSPUR intervention (Week 16 minus Week 11) minus the change for the Attention Control (Week 16 minus Week 11).|The treatment difference (LARKSPUR Intervention vs. Attention Control) in change from Week 11 (Post-Intervention) to Week 16 (1 Month Post-Intervention) was tested using a mixed effects model with two treatment groups and two time points (Week 11, Week 16) and their interaction adjusting for baseline PANAS-GEN scores. Sample size was chosen based on feasibility indicators (recruitment, retention, adherence) rather than on formal power analyses.||0.32|-0.18|0.577
72489662|NCT04869345|144507220|SUPERIORITY||Mean Difference (Final Values)|-0.09|STANDARD_ERROR_OF_MEAN|0.11||0.403|TWO_SIDED|95.0|-0.32|0.13||The threshold for statistical significance was 0.05.|Mixed Models Analysis|Degrees of freedom and standard error estimates were adjusted using the Kenward-Roger (1997) method.|The estimated Mean Difference compares the LARKSPUR intervention minus the Attention Control.|The treatment difference (LARKSPUR Intervention vs. Attention Control) at Week 11 (Post-Intervention) was tested using a mixed effects model with two treatment groups and two time points (Week 11, Week 16) and their interaction adjusting for baseline PSS scores. Sample size was chosen based on feasibility indicators (recruitment, retention, adherence) rather than on formal power analyses.||0.13|-0.32|0.403
72516252|NCT02505542|144563552|OTHER||LS Mean Difference vs Placebo|-0.6|STANDARD_ERROR_OF_MEAN|0.76|=|0.432|TWO_SIDED|95.0|-2.11|0.91|||ANCOVA|||"Only MRIs performed ± 2 weeks around the Week 96 or Early Withdrawal Visit were assigned to Week 96 or Early Withdrawal.~Only results of the double-read assessments of the central MRI review were included. The analysis used the average of the scores from the 2 independent reviewers. Whenever an adjudication was present, the average score across all 3 reviewers was used.~ANCOVA model with treatment, geographical region, mNY classification, and Part B Baseline as covariates."||0.91|-2.11|=0.432
72516253|NCT02505542|144563553|OTHER||LS Mean Difference vs Placebo|-0.4|STANDARD_ERROR_OF_MEAN|0.19|=|0.04|TWO_SIDED|95.0|-0.78|-0.02|||ANCOVA|||"Only MRIs performed ± 2 weeks around the Week 96 or Early Withdrawal Visit were assigned to Week 96 or Early Withdrawal.~Only results of the double-read assessments of the central MRI review were included. The analysis used the average of the scores from the 2 independent reviewers. Whenever an adjudication was present, the average score across all 3 reviewers was used.~ANCOVA model with treatment, geographical region, mNY classification, and Part B Baseline as covariates."||-0.02|-0.78|=0.040
72516254|NCT02505542|144563553|OTHER||LS Mean Difference vs Placebo|-0.3|STANDARD_ERROR_OF_MEAN|0.19|=|0.074|TWO_SIDED|95.0|-0.73|0.03|||ANCOVA|||"Only MRIs performed ± 2 weeks around the Week 96 or Early Withdrawal Visit were assigned to Week 96 or Early Withdrawal.~Only results of the double-read assessments of the central MRI review were included. The analysis used the average of the scores from the 2 independent reviewers. Whenever an adjudication was present, the average score across all 3 reviewers was used.~ANCOVA model with treatment, geographical region, mNY classification, and Part B Baseline as covariates."||0.03|-0.73|=0.074
72516255|NCT01668030|144563571|SUPERIORITY|||||||0.0853|||||||t-test, 2 sided|||||||.0853
72516256|NCT00618995|144563572|NON_INFERIORITY_OR_EQUIVALENCE|Two treatments are comparable if the geometric mean ratio (GMR) is contained within the interval \[0.50-2.00\].|Geometric least-squares mean ratio|0.97||||||90.0|0.8|1.18||||||The endpoint is the urine levels of 11-dTxB2 on Day 7 following a 7 day course of daily dosing in the overall 24 hour collection interval. The point estimate and 90% confidence intervals (CIs) were calculated for the geometric mean ratio (GMR) \[Treatment A/B\] of the urine levels of 11-dTxB2 on Day 7.||1.18|0.8|
72516257|NCT00618995|144563572|SUPERIORITY_OR_OTHER||Geometric least-squares mean ratio|0.94||||||90.0|0.77|1.14||||||||1.14|0.77|
72516258|NCT00618995|144563572|SUPERIORITY_OR_OTHER||Geometric least-squares mean ratio|0.87||||||90.0|0.71|1.05||||||||1.05|0.71|
72516259|NCT00618995|144563572|SUPERIORITY_OR_OTHER||Geometric least-squares mean ratio|0.84||||||90.0|0.69|1.02||||||||1.02|0.69|
72568584|NCT04168190|144668501|OTHER|Geometric mean concentration (GMC) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMC Ratio|0.76|||||TWO_SIDED|95.0|0.42|1.38|||||Phase 1: V116 0.5 mL/Phase 1: Pneumovax™23|Serotype 11A||1.38|0.42|
72568585|NCT04168190|144668501|OTHER|Geometric mean concentration (GMC) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMC Ratio|1.59|||||TWO_SIDED|95.0|0.87|2.91|||||Phase 1: V116 1.0 mL/Phase 1: Pneumovax™23|Serotype 11A||2.91|0.87|
72568586|NCT04168190|144668501|OTHER|Geometric mean concentration (GMC) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMC Ratio|1.04|||||TWO_SIDED|95.0|0.5|2.17|||||Phase 1: V116 0.5 mL/Phase 1: Pneumovax™23|Serotype 12F||2.17|0.50|
72489663|NCT04869345|144507220|SUPERIORITY||Mean Difference (Final Values)|-0.21|STANDARD_ERROR_OF_MEAN|0.11||0.062|TWO_SIDED|95.0|-0.44|0.01||The threshold for statistical significance was 0.05.|Mixed Models Analysis|Degrees of freedom and standard error estimates were adjusted using the Kenward-Roger (1997) method.|The estimated Mean Difference compares the LARKSPUR intervention minus the Attention Control.|The treatment difference (LARKSPUR Intervention vs. Attention Control) at Week 16 (1 Month Post-Intervention) was tested using a mixed effects model with two treatment groups and two time points (Week 11, Week 16) and their interaction adjusting for baseline PROMIS PSS scores. Sample size was chosen based on feasibility indicators (recruitment, retention, adherence) rather than on formal power analyses.||0.01|-0.44|0.062
72489664|NCT04869345|144507220|SUPERIORITY||Mean Difference (Net)|-0.12|STANDARD_ERROR_OF_MEAN|0.11||0.269|TWO_SIDED|95.0|-0.33|0.09||The threshold for statistical significance was 0.05.|Mixed Models Analysis|Degrees of freedom and standard error estimates were adjusted using the Kenward-Roger (1997) method.|The estimated Mean Difference (Net) compares the change for the LARKSPUR intervention (Week 16 minus Week 11) minus the change for the Attention Control (Week 16 minus Week 11).|The treatment difference (LARKSPUR Intervention vs. Attention Control) in change from Week 11 (Post-Intervention) to Week 16 (1 Month Post-Intervention) was tested using a mixed effects model with two treatment groups and two time points (Week 11, Week 16) and their interaction adjusting for baseline PSS scores. Sample size was chosen based on feasibility indicators (recruitment, retention, adherence) rather than on formal power analyses.||0.09|-0.33|0.269
72516260|NCT00618995|144563572|SUPERIORITY_OR_OTHER||Geometric least-squares mean ratio|0.92||||||90.0|0.76|1.13||||||||1.13|0.76|
72516261|NCT00618995|144563572|SUPERIORITY_OR_OTHER||Geometric least-squares mean ratio|0.9||||||90.0|0.74|1.09||||||||1.09|0.74|
72516262|NCT00618995|144563573|SUPERIORITY_OR_OTHER||Geometric least-squares mean ratio|0.94||||||90.0|0.84|1.06||||||||1.06|0.84|
72568587|NCT04168190|144668501|OTHER|Geometric mean concentration (GMC) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMC Ratio|2.14|||||TWO_SIDED|95.0|1.02|4.5|||||Phase 1: V116 1.0 mL/Phase 1: Pneumovax™23|Serotype 12F||4.50|1.02|
72624379|NCT00863304|144778631|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.41|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-0.57|-0.24||P-value was based on pairwise comparisons.|ANCOVA|||Week 16: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.24|-0.57|<0.001
72624380|NCT00863304|144778631|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.37|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-0.53|-0.2||P-value was based on pairwise comparisons.|ANCOVA|||Week 16: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.20|-0.53|<0.001
72516263|NCT00618995|144563573|SUPERIORITY_OR_OTHER||Geometric least-squares mean ratio|0.94||||||90.0|0.84|1.05||||||||1.05|0.84|
72516264|NCT00618995|144563573|SUPERIORITY_OR_OTHER||Geometric least-squares mean ratio|0.57||||||90.0|0.51|0.64||||||||0.64|0.51|
72516265|NCT00618995|144563573|SUPERIORITY_OR_OTHER||Geometric least-squares mean ratio|0.54||||||90.0|0.48|0.6||||||||0.60|0.48|
72516266|NCT00618995|144563573|SUPERIORITY_OR_OTHER||Geometric least-squares mean ratio|0.6||||||90.0|0.54|0.67||||||||0.67|0.54|
72516267|NCT00618995|144563573|SUPERIORITY_OR_OTHER||Geometric least-squares mean ratio|0.57||||||90.0|0.51|0.64||||||||0.64|0.51|
72516268|NCT02988219|144563574|SUPERIORITY_OR_OTHER|||||||0.3861|||||||Chi-squared|||Bradycardia during surgery||||0.3861
72516269|NCT02988219|144563574|SUPERIORITY_OR_OTHER|||||||0.2591|||||||Chi-squared|||No bradycardia observed in the perioperative period||||0.2591
72516270|NCT02988219|144563575|SUPERIORITY_OR_OTHER|||||||0.597|||||||Chi-squared|||Arrhythmia before surgery||||0.597
72516271|NCT02988219|144563575|SUPERIORITY_OR_OTHER|||||||0.4|||||||Chi-squared|||arrhythmia during surgery||||0.4
72568588|NCT04168190|144668501|OTHER|Geometric mean concentration (GMC) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMC Ratio|2.11|||||TWO_SIDED|95.0|1.21|3.68|||||Phase 1: V116 0.5 mL/Phase 1: Pneumovax™23|Serotype 17F||3.68|1.21|
72568589|NCT04168190|144668501|OTHER|Geometric mean concentration (GMC) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMC Ratio|2.87|||||TWO_SIDED|95.0|1.64|5.03|||||Phase 1: V116 1.0 mL/Phase 1: Pneumovax™23|Serotype 17F||5.03|1.64|
72568590|NCT04168190|144668501|OTHER|Geometric mean concentration (GMC) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMC Ratio|1.65|||||TWO_SIDED|95.0|0.93|2.93|||||Phase 1: V116 0.5 mL/Phase 1: Pneumovax™23|Serotype 20A||2.93|0.93|
72568591|NCT04168190|144668501|OTHER|Geometric mean concentration (GMC) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMC Ratio|1.92|||||TWO_SIDED|95.0|1.07|3.43|||||Phase 1: V116 1.0 mL/Phase 1: Pneumovax™23|Serotype 20A||3.43|1.07|
72568592|NCT04168190|144668502|OTHER|Geometric mean concentration (GMC) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMC Ratio|4.29|||||TWO_SIDED|95.0|1.99|9.25|||||Phase 1: V116 0.5 mL/Phase 1: Pneumovax™23|Serotype 6A||9.25|1.99|
72624381|NCT00863304|144778631|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.21|STANDARD_ERROR_OF_MEAN|0.08||0.012|TWO_SIDED|95.0|-0.37|-0.05||P-value was based on pairwise comparisons.|ANCOVA|||Week 16: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.05|-0.37|0.012
72489665|NCT04869345|144507221|SUPERIORITY||Mean Difference (Net)|0.2|STANDARD_ERROR_OF_MEAN|0.07||0.003|TWO_SIDED|95.0|0.07|0.33||The threshold for statistical significance was 0.05.|Mixed Models Analysis|Degrees of freedom and standard error estimates were adjusted using the Kenward-Roger (1997) method.|The estimated Mean Difference (Net) compares the change for the LARKSPUR intervention (Week 11 minus Baseline) minus the change for the Attention Control (Week 11 minus Baseline).|The treatment difference (LARKSPUR Intervention vs. Attention Control) in change from Baseline to Week 11 (Post-Intervention) was tested using a mixed effects model with two treatment groups and three time points (Baseline, Week 11, Week 16) and their interaction while accounting for heterogeneous (random slopes) linear daily trends. Sample size was chosen based on feasibility indicators (recruitment, retention, adherence) rather than on formal power analyses.||0.33|0.07|0.003
72489666|NCT04869345|144507221|SUPERIORITY||Mean Difference (Net)|0.18|STANDARD_ERROR_OF_MEAN|0.07||0.006|TWO_SIDED|95.0|0.05|0.31||The threshold for statistical significance was 0.05.|Mixed Models Analysis|Degrees of freedom and standard error estimates were adjusted using the Kenward-Roger (1997) method.|The estimated Mean Difference (Net) compares the change for the LARKSPUR intervention (Week 16 minus Baseline) minus the change for the Attention Control (Week 16 minus Baseline).|The treatment difference (LARKSPUR Intervention vs. Attention Control) in change from Baseline to Week 16 (1 Month Post-Intervention) was tested using a mixed effects model with two treatment groups and three time points (Baseline, Week 11, Week 16) and their interaction while accounting for heterogeneous (random slopes) linear daily trends. Sample size was chosen based on feasibility indicators (recruitment, retention, adherence) rather than on formal power analyses.||0.31|0.05|0.006
72489667|NCT04869345|144507221|SUPERIORITY||Mean Difference (Net)|-0.02|STANDARD_ERROR_OF_MEAN|0.07||0.796|TWO_SIDED|95.0|-0.15|0.12||The threshold for statistical significance was 0.05.|Mixed Models Analysis|Degrees of freedom and standard error estimates were adjusted using the Kenward-Roger (1997) method.|The estimated Mean Difference (Net) compares the change for the LARKSPUR intervention (Week 16 minus Week 11) minus the change for the Attention Control (Week 16 minus Week 11).|The treatment difference (LARKSPUR Intervention vs. Attention Control) in change from Week 11 (Post-Intervention) to Week 16 (1 Month Post-Intervention) was tested using a mixed effects model with two treatment groups and three time points (Baseline, Week 11, Week 16) and their interaction while accounting for heterogeneous (random slopes) linear daily trends. Sample size was chosen based on feasibility indicators (recruitment, retention, adherence) rather than on formal power analyses.||0.12|-0.15|0.796
72489668|NCT04869345|144507222|SUPERIORITY||Mean Difference (Net)|0.01|STANDARD_ERROR_OF_MEAN|0.02||0.758|TWO_SIDED|95.0|-0.03|0.05||The threshold for statistical significance was 0.05.|Mixed Models Analysis|Degrees of freedom and standard error estimates were adjusted using the Kenward-Roger (1997) method.|The estimated Mean Difference (Net) compares the change for the LARKSPUR intervention (Week 11 minus Baseline) minus the change for the Attention Control (Week 11 minus Baseline).|The treatment difference (LARKSPUR Intervention vs. Attention Control) in change from Baseline to Week 11 (Post-Intervention) was tested using a mixed effects model with two treatment groups and three time points (Baseline, Week 11, Week 16) and their interaction while accounting for heterogeneous (random slopes) linear daily trends. Sample size was chosen based on feasibility indicators (recruitment, retention, adherence) rather than on formal power analyses.||0.05|-0.03|0.758
72516272|NCT02988219|144563575|SUPERIORITY_OR_OTHER|||||||0.6544|||||||Chi-squared|||arrhythmia after surgery||||0.6544
72516273|NCT02988219|144563575|SUPERIORITY_OR_OTHER|||||||0.077|||||||Chi-squared|||long QTc \> 0.45s after surgery||||0.077
72516274|NCT02988219|144563575|SUPERIORITY_OR_OTHER|||||||0.0174|||||||Chi-squared|||long QTc \> 0.24 s in the perioperative time||||0.0174
72516275|NCT01522443|144563576|SUPERIORITY_OR_OTHER|||||||0.773|||||||Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel (CMH) was stratified by the Eastern Cooperative Oncology Group performance status and prior cabazitaxel use.||||||0.773
72516276|NCT01522443|144563577|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel (CMH) Test was stratified by baslined Eastern Cooperative Oncology Group performance status and prior cabazitaxel use.||||||<0.001
72516277|NCT01522443|144563578|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.7||||0.121|TWO_SIDED|95.0|0.44|1.1|||Log Rank|The Log-Rank Test was stratified by baseline Eastern Cooperative Oncology Group performance status and prior cabazitaxel use.||||1.10|0.44|0.121
72516278|NCT01764256|144563582|EQUIVALENCE|Definition of equivalence: p\<0.05||||||0.44|||||||Fisher Exact|||Proportion of subjects with at least one unsolicited adverse event (related or unrelated)||||0.44
72516279|NCT01764256|144563582|EQUIVALENCE|Definition of equivalence: p\<0.05||||||0.7446|||||||Fisher Exact|||Proportion of subjects with at least one unsolicited adverse event: potentially related||||0.7446
72516280|NCT01764256|144563583|EQUIVALENCE|Equivalence was defined as p\<0.05.||||||0.5694|||||||Fisher Exact|||Proportion of subjects per Group with any Moderate or Higher Reaction (systemic or local reaction)||||0.5694
72516281|NCT01764256|144563583|EQUIVALENCE|Equivalence was defined as p\<0.05.||||||1|||||||Fisher Exact|||Proportion of subjects per Group with any Moderate or Higher Reaction (systemic reaction)||||1.0000
72624382|NCT00863304|144778631|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.08||0.02|TWO_SIDED|95.0|-0.36|-0.03||P-value was based on pairwise comparisons.|ANCOVA|||Week 16: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.03|-0.36|0.020
72624383|NCT00863304|144778631|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.08||0.064|TWO_SIDED|95.0|-0.32|0.01||P-value was based on pairwise comparisons.|ANCOVA|||Week 16: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||0.01|-0.32|0.064
72516282|NCT01764256|144563583|EQUIVALENCE|Equivalence was defined as p\<0.05.||||||1|||||||Fisher Exact|||Proportion of subjects per Group with any Moderate or Higher Reaction (local reaction)||||1.0000
72516283|NCT01764256|144563584|EQUIVALENCE|Equivalence was defined as p\<0.05.||||||0.6004|||||||Fisher Exact|||Proportion of subjects per Group with any Moderate or Higher Reaction (systemic or local reaction)||||0.6004
72516284|NCT01764256|144563584|EQUIVALENCE|Equivalence was defined as p\<0.05.||||||1|||||||Fisher Exact|||Proportion of subjects per Group with any Moderate or Higher Reaction (systemic reaction)||||1
72489669|NCT04869345|144507222|SUPERIORITY||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|0.02||0.88|TWO_SIDED|95.0|-0.04|0.04||The threshold for statistical significance was 0.05.|Mixed Models Analysis|Degrees of freedom and standard error estimates were adjusted using the Kenward-Roger (1997) method.|The estimated Mean Difference (Net) compares the change for the LARKSPUR intervention (Week 16 minus Baseline) minus the change for the Attention Control (Week 16 minus Baseline).|The treatment difference (LARKSPUR Intervention vs. Attention Control) in change from Baseline to Week 16 (1 Month Post-Intervention) was tested using a mixed effects model with two treatment groups and three time points (Baseline, Week 11, Week 16) and their interaction while accounting for heterogeneous (random slopes) linear daily trends. Sample size was chosen based on feasibility indicators (recruitment, retention, adherence) rather than on formal power analyses.||0.04|-0.04|0.880
72489670|NCT04869345|144507222|SUPERIORITY||Mean Difference (Net)|-0.01|STANDARD_ERROR_OF_MEAN|0.02||0.652|TWO_SIDED|95.0|-0.05|0.03||The threshold for statistical significance was 0.05.|Mixed Models Analysis|Degrees of freedom and standard error estimates were adjusted using the Kenward-Roger (1997) method.|The estimated Mean Difference (Net) compares the change for the LARKSPUR intervention (Week 16 minus Week 11) minus the change for the Attention Control (Week 16 minus Week 11).|The treatment difference (LARKSPUR Intervention vs. Attention Control) in change from Week 11 (Post-Intervention) to Week 16 (1 Month Post-Intervention) was tested using a mixed effects model with two treatment groups and three time points (Baseline, Week 11, Week 16) and their interaction while accounting for heterogeneous (random slopes) linear daily trends. Sample size was chosen based on feasibility indicators (recruitment, retention, adherence) rather than on formal power analyses.||0.03|-0.05|0.652
72489671|NCT00916357|144507287|SUPERIORITY_OR_OTHER|||||||0.0034||||||Treatment comparison of Humalog alone and Humalog + recombinant human hyaluronidase PH20 (rHuPH20).|Repeated Measures Analysis of Variance|||60 minutes after study drug injection.||||0.0034
72489672|NCT00916357|144507287|SUPERIORITY_OR_OTHER|||||||0.26||||||Treatment comparison of Humalog alone and Humulin-R + recombinant human hyaluronidase PH20 (rHuPH20).|Repeated Measures Analysis of Variance|||60 minutes after study drug injection.||||0.2600
72489673|NCT00916357|144507287|SUPERIORITY_OR_OTHER|||||||0.0001||||||Treatment comparison of Humalog + recombinant human hyaluronidase PH20 (rHuPH20) and Humulin-R + rHuPH20.|Repeated measures Analysis of Variance|||60 minutes after study drug injection.||||0.0001
72489674|NCT00916357|144507287|SUPERIORITY_OR_OTHER|||||||0.0039||||||Treatment comparison of Humalog alone and Humalog + recombinant human hyaluronidase PH20 (rHuPH20).|Repeated Measures Analysis of Variance|||90 minutes after study drug injection.||||0.0039
72516285|NCT01764256|144563584|EQUIVALENCE|Equivalence was defined as p\<0.05.||||||1|||||||Fisher Exact|||Proportion of subjects per Group with any Moderate or Higher Reaction (local reaction)||||1.00
72404343|NCT00923559|144315465|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|8.69|STANDARD_ERROR_OF_MEAN|3.04||0.006||95.0|2.64|14.74||Null hypothesis MIP and CHC care should yield equal outcomes. A priori threshold p\<.05.|Regression, Linear|Degrees of freedom (df) = 68.3||Null hypothesis: MIP and CHC care should yield equal outcomes. For power calculations, studies on the EPDS and the SPSQ were used. An estimated power of .80 and a two-tailed significance of .05 would necessitate between 29 and 60 participants. Forty dyads per group were chosen.||14.74|2.64|.006
72404344|NCT00923559|144315466|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.57|STANDARD_ERROR_OF_MEAN|1.06||0.018|TWO_SIDED|95.0|0.46|4.68||p-value unadjusted for multiple comparisons. A priori threshold p\<.05.|Regression, Linear|Degrees of freedom (df) = 69.3||Null hypothesis: MIP and CHC care should yield equal outcomes. For power calculations, studies on the EPDS and the SPSQ were used. An estimated power of .80 and a two-tailed significance of .05 would necessitate between 29 and 60 participants. Forty dyads per group were chosen.||4.68|0.46|.018
72516286|NCT01764256|144563585|EQUIVALENCE|Equivalence was defined as p\<0.05.||||||1|||||||Fisher Exact|||Proportion of subjects per Group with any Moderate or Higher Reaction (systemic or local reaction)||||1.0000
72489675|NCT00916357|144507287|SUPERIORITY_OR_OTHER|||||||0.93||||||Treatment comparison of Humalog alone and Humulin-R + recombinant human hyaluronidase PH20 (rHuPH20).|Repeated Measures Analysis of Variance|||90 minutes after study drug injection.||||0.9300
72489676|NCT00916357|144507287|SUPERIORITY_OR_OTHER|||||||0.0031||||||Treatment comparison of Humalog + recombinant human hyaluronidase PH20 (rHuPH20) and Humulin-R + rHuPH20.|Repeated Measures Analysis of Variance|||90 minutes after study drug injection.||||0.0031
72516287|NCT01764256|144563585|EQUIVALENCE|Equivalence defined as p\<0.05||||||1|||||||Fisher Exact|||Proportion of subjects per Group with any Moderate or Higher Reaction (systemic)||||1.0000
72516288|NCT01764256|144563585|EQUIVALENCE|Equivalence was defined as p\<0.05||||||1|||||||Fisher Exact|||Proportion of subjects per Group with any Moderate or Higher Reaction (local reaction)||||1.0000
72489677|NCT00916357|144507287|SUPERIORITY_OR_OTHER|||||||0.019||||||Treatment comparison of Humalog alone and Humalog + recombinant human hyaluronidase PH20 (rHuPH20).|Repeated Measures Analysis of Variance|||120 minutes after study drug injection.||||0.0190
72489678|NCT00916357|144507287|SUPERIORITY_OR_OTHER|||||||0.92||||||Treatment comparison of Humalog alone and Humulin-R + recombinant human hyaluronidase PH20 (rHuPH20).|Repeated Measures Analysis of Variance|||120 minutes after study drug injection.||||0.9200
72489679|NCT00916357|144507287|SUPERIORITY_OR_OTHER|||||||0.015||||||Treatment comparison of Humalog + recombinant human hyaluronidase PH20 (rHuPH20) and Humulin-R + rHuPH20.|Repeated Measures Analysis of Variance|||120 minutes after study drug injection.||||0.0150
72516289|NCT01764256|144563586|EQUIVALENCE|Equivalence was defined as p\<0.05||||||1|||||||Fisher Exact|||Proportion of subjects per Group with any Moderate or Higher Reaction (systemic or local reaction)||||1.0000
72516290|NCT01764256|144563586|EQUIVALENCE|Equivalence was defined as p\<0.05||||||1|||||||Fisher Exact|||Proportion of subjects per Group with any Moderate or Higher Reaction (systemic)||||1.0000
72516291|NCT01764256|144563586|EQUIVALENCE|Equivalence was defined as p\<0.05.||||||1|||||||Fisher Exact|||Proportion of subjects per Group with any Moderate or Higher Reaction (local reaction)||||1.0000
72568593|NCT04168190|144668502|OTHER|Geometric mean concentration (GMC) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMC Ratio|5.49|||||TWO_SIDED|95.0|2.53|11.91|||||Phase 1: V116 1.0 mL/Phase 1: Pneumovax™23|Serotype 6A||11.91|2.53|
72489680|NCT00916357|144507287|SUPERIORITY_OR_OTHER|||||||0.095||||||Treatment comparison of Humalog alone and Humalog + recombinant human hyaluronidase PH20 (rHuPH20).|Repeated Measures Analysis of Variance|||Peak postprandial glucose (PPG) values.||||0.0950
72489681|NCT00916357|144507287|SUPERIORITY_OR_OTHER|||||||0.6||||||Treatment comparison of Humalog alone and Humulin-R + recombinant human hyaluronidase PH20 (rHuPH20).|Repeated Measures Analysis of Variance|||Peak postprandial glucose (PPG) values.||||0.6000
72489682|NCT00916357|144507287|SUPERIORITY_OR_OTHER|||||||0.031||||||Treatment comparison of Humalog + recombinant human hyaluronidase PH20 (rHuPH20) and Humulin-R + rHuPH20.|Repeated Measures Analysis of Variance|||Peak postprandial glucose (PPG) values.||||0.0310
72516292|NCT03373110|144563593|OTHER|||||||0.973||||||A two-sided significance level of 0.05 was used for all analyses.|Mixed Models Analysis|||We used linear mixed effects models fit via maximum likelihood to examine the effect of the interventions on daily steps. The models include a random intercept and fixed effects for intervention, time, and an intervention by time interaction. We used separate models to assess the intervention effects across the 8-week intervention period as well as the complete 16-week follow-up period.|The models include a random intercept and fixed effects for intervention, time, and an intervention by time interaction.|||0.973
72516293|NCT03373110|144563593|OTHER|||||||0.005||||||A two-sided significance level of 0.05 was used for all analyses.|Mixed Models Analysis|||We used linear mixed effects models to examine the effect of the interventions on average daily steps at 8 weeks into the study. These models account for the covariance of repeated measurements within subjects, and we used maximum likelihood estimation to adjust for missing daily step counts. The models include a random intercept and fixed effects for intervention, time, and an intervention by time interaction.|We used linear mixed effects models to examine the effect of the interventions on daily steps. These models account for the covariance of repeated measurements within subjects, and we used maximum likelihood estimation to account for missing daily step counts. The models include a random intercept and fixed effects for intervention, time, and an intervention by time interaction.|||.005
72516294|NCT03373110|144563593|OTHER|||||||0.004||||||A two-sided significance level of 0.05 was used for all analyses.|Mixed Models Analysis|||We used linear mixed effects models to examine the effect of the interventions on average daily steps at 8 weeks into the study. These models account for the covariance of repeated measurements within subjects, and we used maximum likelihood estimation to adjust for missing daily step counts. The models include a random intercept and fixed effects for intervention, time, and an intervention by time interaction.|We used linear mixed effects models to examine the effect of the interventions on daily steps. These models account for the covariance of repeated measurements within subjects, and we used maximum likelihood estimation to account for missing daily step counts. The models include a random intercept and fixed effects for intervention, time, and an intervention by time interaction.|||.004
72516295|NCT03373110|144563593|OTHER|||||||0.627||||||A two-sided significance level of 0.05 was used for all analyses.|Mixed Models Analysis|||We used linear mixed effects models to examine the effect of the interventions on average daily steps at 16 weeks into the study. These models account for the covariance of repeated measurements within subjects, and we used maximum likelihood estimation to adjust for missing daily step counts. The models include a random intercept and fixed effects for intervention, time, and an intervention by time interaction.|We used linear mixed effects models to examine the effect of the interventions on daily steps. These models account for the covariance of repeated measurements within subjects, and we used maximum likelihood estimation to account for missing daily step counts. The models include a random intercept and fixed effects for intervention, time, and an intervention by time interaction.|||0.627
72516296|NCT03373110|144563593|OTHER|||||||0.359||||||A two-sided significance level of 0.05 was used for all analyses.|Mixed Models Analysis|||We used linear mixed effects models to examine the effect of the interventions on average daily steps at 16 weeks into the study. These models account for the covariance of repeated measurements within subjects, and we used maximum likelihood estimation to adjust for missing daily step counts. The models include a random intercept and fixed effects for intervention, time, and an intervention by time interaction.|We used linear mixed effects models to examine the effect of the interventions on daily steps. These models account for the covariance of repeated measurements within subjects, and we used maximum likelihood estimation to account for missing daily step counts. The models include a random intercept and fixed effects for intervention, time, and an intervention by time interaction.|||0.359
72568594|NCT04168190|144668502|OTHER|Geometric mean concentration (GMC) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMC Ratio|5.05|||||TWO_SIDED|95.0|2.59|9.85|||||Phase 1: V116 0.5 mL/Phase 1: Pneumovax™23|Serotype 15A||9.85|2.59|
72568595|NCT04168190|144668502|OTHER|Geometric mean concentration (GMC) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMC Ratio|8.92|||||TWO_SIDED|95.0|4.55|17.5|||||Phase 1: V116 1.0 mL/Phase 1: Pneumovax™23|Serotype 15A||17.50|4.55|
72568596|NCT04168190|144668502|OTHER|Geometric mean concentration (GMC) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMC Ratio|4.4|||||TWO_SIDED|95.0|2.38|8.15|||||Phase 1: V116 0.5 mL/Phase 1: Pneumovax™23|Serotype 15C||8.15|2.38|
72489683|NCT00916357|144507288|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Treatment comparison of Humalog alone and Humalog + recombinant human hyaluronidase PH20 (rHuPH20).|Repeated Measures Analysis of Variance|||||||<0.0001
72489684|NCT00916357|144507288|SUPERIORITY_OR_OTHER|||||||0.18||||||Treatment comparison of Humalog alone and Humulin-R + recombinant human hyaluronidase PH20 (rHuPH20).|Repeated Measures Analysis of Variance|||||||0.1800
72489685|NCT00916357|144507288|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Treatment comparison of Humalog + recombinant human hyaluronidase PH20 (rHuPH20) and Humulin-R + rHuPH20.|Repeated Measures Analysis of Variance|||||||<0.0001
72489686|NCT00916357|144507289|SUPERIORITY_OR_OTHER|||||||0.0045||||||Treatment comparison of Humalog alone and Humalog + recombinant human hyaluronidase PH20 (rHuPH20).|Repeated Measures Analysis of Variance|||||||0.0045
72489687|NCT00916357|144507289|SUPERIORITY_OR_OTHER|||||||0.48||||||Treatment comparison of Humalog alone and Humulin-R + recombinant human hyaluronidase PH20 (rHuPH20).|Repeated Measures Analysis of Variance|||||||0.4800
72489688|NCT00916357|144507289|SUPERIORITY_OR_OTHER|||||||0.0006||||||Treatment comparison of Humalog + recombinant human hyaluronidase PH20 (rHuPH20) and Humulin-R + rHuPH20.|Repeated Measures Analysis of Variance|||||||0.0006
72489689|NCT00916357|144507290|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Treatment comparison of Humalog alone and Humalog + recombinant human hyaluronidase PH20 (rHuPH20).|Repeated Measures Analysis of Variance|||||||<0.0001
72489690|NCT00916357|144507290|SUPERIORITY_OR_OTHER|||||||0.0016||||||Treatment comparison of Humalog alone and Humalog + recombinant human hyaluronidase PH20 (rHuPH20).|Repeated Measures Analysis of Variance|||||||0.0016
72489691|NCT00916357|144507290|SUPERIORITY_OR_OTHER|||||||0.1||||||Treatment comparison of Humalog + recombinant human hyaluronidase PH20 (rHuPH20) and Humulin-R + rHuPH20.|Repeated Measures Analysis of Variance|||||||0.1000
72489692|NCT00916357|144507291|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Treatment comparison of Humalog alone + Humalog + recombinant human hyaluronidase PH20 (rHuPH20).|Repeated Measures Analysis of Variance|||||||<0.0001
72489693|NCT00916357|144507291|SUPERIORITY_OR_OTHER|||||||0.3||||||Treatment comparison for Humalog alone and Humulin-R + recombinant human hyaluronidase PH20 (rHuPH20).|Repeated Measures Analysis of Variance|||||||0.3000
72489694|NCT00916357|144507291|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Treatment comparison of Humalog + recombinant human hyaluronidase PH20 (rHuPH20) and Humulin-R + rHuPH20.|Repeated Measures Analysis of Variance|||||||<0.0001
72489695|NCT00916357|144507292|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Treatment comparison of Humalog alone and Humalog + recombinant human hyaluronidase PH20 (rHuPH20).|Repeated Measures Analysis of Variance|||||||<0.0001
72489696|NCT00916357|144507292|SUPERIORITY_OR_OTHER|||||||0.77||||||Treatment comparison of Humalog alone and Humulin-R + recombinant human hyaluronidase PH20 (rHuPH20).|Repeated Measures Analysis of Variance|||||||0.7700
72489697|NCT00916357|144507292|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Treatment comparison of Humalog + recombinant human hyaluronidase PH20 (rHuPH20) and Humulin-R + rHuPH20.|Repeated Measures Analysis of Variance|||||||<0.0001
72568597|NCT04168190|144668502|OTHER|Geometric mean concentration (GMC) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMC Ratio|4.92|||||TWO_SIDED|95.0|2.64|9.16|||||Phase 1: V116 1.0 mL/Phase 1: Pneumovax™23|Serotype 15C||9.16|2.64|
72404345|NCT00923559|144315467|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.27|STANDARD_ERROR_OF_MEAN|0.24||0.266|TWO_SIDED|95.0|-0.21|0.75||p-value unadjusted for multiple comparisons. A priori threshold p\<.05.|Regression, Linear|Degrees of freedom = 73.4||Null hypothesis: MIP and CHC care should yield equal outcomes. For power calculations, studies on the EPDS and the SPSQ were used. An estimated power of .80 and a two-tailed significance of .05 would necessitate between 29 and 60 participants. Forty dyads per group were chosen.||0.75|-0.21|.266
72489698|NCT00916357|144507293|SUPERIORITY_OR_OTHER|||||||0.01||||||Treatment comparison of Humalog alone and Humalog + recombinant human hyaluronidase PH20 (rHuPH20).|Repeated Measures Analysis of Variance|||||||0.0100
72489699|NCT00916357|144507293|SUPERIORITY_OR_OTHER|||||||0.82||||||Treatment comparison of Humalog alone and Humulin-R + recombinant human hyaluronidase PH20 (rHuPH20).|Repeated Measures Analysis of Variance|||||||0.8200
72489700|NCT00916357|144507293|SUPERIORITY_OR_OTHER|||||||0.0056||||||Treatment comparison of Humalog + recombinant human hyaluronidase PH20 (rHuPH20) and Humulin-R + rHuPH20.|Repeated Measures Analysis of Variance|||||||0.0056
72489701|NCT00916357|144507294|SUPERIORITY_OR_OTHER|||||||0.064||||||Treatment comparison of Humalog alone and Humalog + recombinant human hyaluronidase PH20 (rHuPH20).|Repeated Measures Analysis of Variance|||Participants with blood glucose (BG) \>160 milligrams per deciliter (mg/dL)||||0.064
72489702|NCT00916357|144507294|SUPERIORITY_OR_OTHER|||||||0.47||||||Treatment comparison of Humalog alone and Humulin-R + recombinant human hyaluronidase PH20 (rHuPH20).|Repeated Measures Analysis of Variance|||Participants with blood glucose (BG) \>160 milligrams per deciliter (mg/dL)||||0.47
72489703|NCT00916357|144507294|SUPERIORITY_OR_OTHER|||||||0.012||||||Treatment comparison of Humalog + recombinant human hyaluronidase PH20 (rHuPH20) and Humulin-R + rHuPH20.|Repeated Measures Analysis of Variance|||Participants with blood glucose (BG) \>160 milligrams per deciliter (mg/dL)||||0.012
72489704|NCT00916357|144507294|SUPERIORITY_OR_OTHER|||||||0.099||||||Treatment comparison of Humalog alone and Humalog + recombinant human hyaluronidase PH20 (rHuPH20).|Repeated Measures Analysis of Variance|||Participants with blood glucose (BG) \>140 milligrams per deciliter (mg/dL)||||0.099
72489705|NCT00916357|144507294|SUPERIORITY_OR_OTHER|||||||0.46||||||Treatment comparison of Humalog alone and Humulin-R + recombinant human hyaluronidase PH20 (rHuPH20).|Repeated Measures Analysis of Variance|||Participants with blood glucose (BG) \>140 milligrams per deciliter (mg/dL)||||0.46
72489706|NCT00916357|144507294|SUPERIORITY_OR_OTHER|||||||0.02||||||Treatment comparison of Humalog + recombinant human hyaluronidase PH20 (rHuPH20) and Humulin-R + rHuPH20.|Repeated Measures Analysis of Variance|||Participants with blood glucose (BG) \>140 milligrams per deciliter (mg/dL)||||0.020
72489707|NCT00916357|144507294|SUPERIORITY_OR_OTHER|||||||0.13||||||Treatment comparison of Humalog alone and Humalog + recombinant human hyaluronidase PH20 (rHuPH20).|Repeated Measures Analysis of Variance|||Participants with blood glucose (BG) \<70 milligrams per deciliter (mg/dL)||||0.13
72489708|NCT00916357|144507294|SUPERIORITY_OR_OTHER|||||||0.41||||||Treatment comparison of Humalog alone and Humulin-R + recombinant human hyaluronidase PH20 (rHuPH20).|Repeated Measures Analysis of Variance|||Participants with blood glucose (BG) \<70 milligrams per deciliter (mg/dL)||||0.41
72489709|NCT00916357|144507294|SUPERIORITY_OR_OTHER|||||||0.46||||||Treatment comparison of Humalog + recombinant human hyaluronidase PH20 (rHuPH20) and Humulin-R + rHuPH20.|Repeated Measures Analysis of Variance|||Participants with blood glucose (BG) \<70 milligrams per deciliter (mg/dL)||||0.46
72489710|NCT00916357|144507295|SUPERIORITY_OR_OTHER|||||||0.016||||||Treatment comparison of Humalog alone and Humalog + recombinant human hyaluronidase PH20 (rHuPH20).|Repeated Measures Analysis of Variance|||||||0.016
72568598|NCT04168190|144668502|OTHER|Geometric mean concentration (GMC) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMC Ratio|3.41|||||TWO_SIDED|95.0|1.97|5.91|||||Phase 1: V116 0.5 mL/Phase 1: Pneumovax™23|Serotype 16F||5.91|1.97|
72568599|NCT04168190|144668502|OTHER|Geometric mean concentration (GMC) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMC Ratio|6.58|||||TWO_SIDED|95.0|3.78|11.45|||||Phase 1: V116 1.0 mL/Phase 1: Pneumovax™23|Serotype 16F||11.45|3.78|
72489711|NCT00916357|144507295|SUPERIORITY_OR_OTHER|||||||0.88||||||Treatment comparison of Humalog alone and Humulin-R + recombinant human hyaluronidase PH20 (rHuPH20).|Repeated Measures Analysis of Variance|||||||0.8800
72489712|NCT00916357|144507295|SUPERIORITY_OR_OTHER|||||||0.011||||||Treatment comparison of Humalog + recombinant human hyaluronidase PH20 (rHuPH20) and Humulin-R + rHuPH20.|Repeated Measures Analysis of Variance|||||||0.011
72489713|NCT00916357|144507297|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Treatment comparison of Humalog alone and Humalog + recombinant human hyaluronidase PH20 (rHuPH20).|Repeated Measures Analysis of Variance|||Analysis for 10% of exposure (area under the curve \[AUC\])||||<0.0001
72489714|NCT00916357|144507297|SUPERIORITY_OR_OTHER|||||||0.18||||||Treatment comparison of Humalog alone and Humulin-R + recombinant human hyaluronidase PH20 (rHuPH20).|Repeated Measures Analysis of Variance|||Analysis for 10% of exposure (area under the curve \[AUC\])||||0.1800
72489715|NCT00916357|144507297|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Treatment comparison of Humalog + recombinant human hyaluronidase PH20 (rHuPH20) and Humulin-R + rHuPH20.|Repeated Measures Analysis of Variance|||Analysis for 10% of exposure (area under the curve \[AUC\])||||<0.0001
72489716|NCT00916357|144507297|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Treatment comparison for Humalog alone and Humalog + recombinant human hyaluronidase PH20 (rHuPH20).|Repeated Measures Analysis of Variance|||Analysis for 50% of exposure (area under the curve \[AUC\])||||<0.0001
72489717|NCT00916357|144507297|SUPERIORITY_OR_OTHER|||||||0.72||||||Treatment comparison of Humalog alone and Humulin-R + recombinant human hyaluronidase PH20 (rHuPH20).|Repeated Measures Analysis of Variance|||Analysis for 50% of exposure (area under the curve \[AUC\])||||0.7200
72489718|NCT00916357|144507297|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Treatment comparison of Humalog + recombinant human hyaluronidase PH20 (rHuPH20) and Humulin-R + rHuPH20.|Repeated Measures Analysis of Variance|||Analysis for 50% of exposure (area under the curve \[AUC\])||||<0.0001
72489719|NCT01308008|144507298|SUPERIORITY||coefficient|0.05||||0.16|TWO_SIDED|95.0|-0.02|0.13|||Regression, Logistic|||||0.13|-0.02|0.16
72489720|NCT01308008|144507299|SUPERIORITY||coefficient|34.0||||0.17|TWO_SIDED|95.0|-15.0|83.0|||Regression, Logistic|||||83|-15|0.17
72489721|NCT01308008|144507300|SUPERIORITY||coefficient|-8.7||||0.5|TWO_SIDED|95.0|-35.0|17.0|||Regression, Logistic|||||17|-35|0.5
72568600|NCT04168190|144668502|OTHER|Geometric mean concentration (GMC) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMC Ratio|9.42|||||TWO_SIDED|95.0|4.35|20.4|||||Phase 1: V116 0.5 mL/Phase 1: Pneumovax™23|Serotype 23A||20.40|4.35|
72489722|NCT01417195|144507301|NON_INFERIORITY_OR_EQUIVALENCE|The pre-defined non-inferiority margin for the lower limit of the 95% CI for the difference in fertilization rate was below -12%.|Mean Difference (Final Values)|3.6|||||TWO_SIDED|95.0|-4.3|11.5|||||"Mean difference = Menopur/Bravelle - Menopur.~95% CI is based on Student's t-distribution, assuming equal variances."|||11.5|-4.3|
72489723|NCT03357731|144507307|SUPERIORITY||Mean Difference (Net)|-2.15|STANDARD_ERROR_OF_MEAN|0.9242||0.027|TWO_SIDED|95.0|-4.0432|-0.257|||Kenward-Roger degree of freedom|Kenward-Roger degree of freedom is used to adjust the standard error of treatment effect|The modelled mean difference uses treatment sequence and difference of baselines as a covariates of the treatment effect.|||-0.2570|-4.0432|0.027
72489724|NCT03357731|144507308|SUPERIORITY||Mean Difference (Net)|0.193|STANDARD_ERROR_OF_MEAN|0.9832||0.846|TWO_SIDED|95.0|-1.8176|2.2042|||Kenward-Roger degree of freedom|Kenward-Roger degree of freedom is used to adjust the standard error of treatment effect|The modelled mean difference uses treatment sequence and difference of baselines as a covariates of the treatment effect.|||2.2042|-1.8176|0.846
72489725|NCT03357731|144507309|SUPERIORITY||Mean Difference (Net)|1.3|STANDARD_ERROR_OF_MEAN|0.93||0.177|TWO_SIDED|95.0|-0.62|3.19|||Kenward-Roger degree of freedom|Kenward-Roger degree of freedom is used to adjust the standard error of treatment effect|The modelled mean difference uses treatment sequence and difference of baselines as a covariates of the treatment effect.|||3.19|-0.62|0.177
72489726|NCT03357731|144507309|SUPERIORITY||Mean Difference (Net)|-0.1|STANDARD_ERROR_OF_MEAN|0.48||0.839|TWO_SIDED|95.0|-1.08|0.88|||Kenward-Roger degree of freedom|Kenward-Roger degree of freedom is used to adjust the standard error of treatment effect|The modelled mean difference uses treatment sequence and difference of baselines as a covariates of the treatment effect.|||0.88|-1.08|0.839
72489727|NCT03357731|144507310|SUPERIORITY||Mean Difference (Net)|-0.0977|STANDARD_ERROR_OF_MEAN|0.03308||0.007|TWO_SIDED|95.0|-0.16634|-0.02915|||Kenward-Roger degree of freedom|Kenward-Roger degree of freedom is used to adjust the standard error of treatment effect|The modelled mean difference uses treatment sequence and difference of baselines as a covariates of the treatment effect.|||-0.02915|-0.16634|0.007
72489728|NCT03357731|144507310|SUPERIORITY||Mean Difference (Net)|-0.0371|STANDARD_ERROR_OF_MEAN|0.02194||0.103|TWO_SIDED|95.0|-0.08243|0.00814|||Kenward-Roger degree of freedom|Kenward-Roger degree of freedom is used to adjust the standard error of treatment effect|The modelled mean difference uses treatment sequence and difference of baselines as a covariates of the treatment effect.|||0.00814|-0.08243|0.103
72489729|NCT03357731|144507311|SUPERIORITY||Mean Difference (Net)|-0.13|STANDARD_ERROR_OF_MEAN|0.037||0.003|TWO_SIDED|95.0|-0.205|-0.051|||Kenward-Roger degree of freedom|Kenward-Roger degree of freedom is used to adjust the standard error of treatment effect|The modelled mean difference uses treatment sequence and difference of baselines as a covariates of the treatment effect.|E/A ratio||-0.051|-0.205|0.003
72489730|NCT03357731|144507311|SUPERIORITY||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|0.026||0.904|TWO_SIDED|95.0|-0.051|0.057|||Kenward-Roger degree of freedom|Kenward-Roger degree of freedom is used to adjust the standard error of treatment effect|The modelled mean difference uses treatment sequence and difference of baselines as a covariates of the treatment effect.|E/A ratio||0.057|-0.051|0.904
72489731|NCT03357731|144507311|SUPERIORITY||Mean Difference (Net)|-1.66|STANDARD_ERROR_OF_MEAN|0.527||0.006|TWO_SIDED|95.0|-2.763|-0.549|||Kenward-Roger degree of freedom|Kenward-Roger degree of freedom is used to adjust the standard error of treatment effect|The modelled mean difference uses treatment sequence and difference of baselines as a covariates of the treatment effect.|E/e' ratio||-0.549|-2.763|0.006
72568601|NCT04168190|144668502|OTHER|Geometric mean concentration (GMC) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMC Ratio|9.46|||||TWO_SIDED|95.0|4.34|20.62|||||Phase 1: V116 1.0 mL/Phase 1: Pneumovax™23|Serotype 23A||20.62|4.34|
72568602|NCT04168190|144668502|OTHER|Geometric mean concentration (GMC) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMC Ratio|3.43|||||TWO_SIDED|95.0|1.95|6.05|||||Phase 1: V116 0.5 mL/Phase 1: Pneumovax™23|Serotype 23B||6.05|1.95|
72489732|NCT03357731|144507311|SUPERIORITY||Mean Difference (Net)|-0.27|STANDARD_ERROR_OF_MEAN|0.392||0.503|TWO_SIDED|95.0|-1.085|0.55|||Kenward-Roger degree of freedom|Kenward-Roger degree of freedom is used to adjust the standard error of treatment effect|The modelled mean difference uses treatment sequence and difference of baselines as a covariates of the treatment effect.|E/e' ratio||0.550|-1.085|0.503
72489733|NCT03357731|144507312|SUPERIORITY||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|0.398||0.994|TWO_SIDED|95.0|-0.827|0.82|||Kenward-Roger degree of freedom|Kenward-Roger degree of freedom is used to adjust the standard error of treatment effect|The modelled mean difference uses treatment sequence and difference of baselines as a covariates of the treatment effect.|annular e' velocity||0.820|-0.827|0.994
72489734|NCT03357731|144507312|SUPERIORITY||Mean Difference (Net)|0.48|STANDARD_ERROR_OF_MEAN|0.258||0.073|TWO_SIDED|95.0|-0.049|1.013|||Kenward-Roger degree of freedom|Kenward-Roger degree of freedom is used to adjust the standard error of treatment effect|The modelled mean difference uses treatment sequence and difference of baselines as a covariates of the treatment effect.|annular e' velocity||1.013|-0.049|0.073
72404346|NCT00923559|144315468|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.16|STANDARD_ERROR_OF_MEAN|0.08||0.052|TWO_SIDED|95.0|0.0|0.32||p-value unadjusted for multiple comparisons. A priori threshold p\<.05.|Regression, Linear|||Null hypothesis: MIP and CHC care should yield equal outcomes. For power calculations, studies on the EPDS and the SPSQ were used. An estimated power of .80 and a two-tailed significance of .05 would necessitate between 29 and 60 participants. Forty dyads per group were chosen.||0.32|0.00|.052
72489735|NCT03357731|144507313|SUPERIORITY||Mean Difference (Net)|0.15|STANDARD_ERROR_OF_MEAN|0.4||0.705|TWO_SIDED|95.0|-0.67|0.976|||Kenward-Roger degree of freedom|Kenward-Roger degree of freedom is used to adjust the standard error of treatment effect|The modelled mean difference uses treatment sequence and difference of baselines as a covariates of the treatment effect.|||0.976|-0.670|0.705
72489736|NCT03357731|144507313|SUPERIORITY||Mean Difference (Net)|-0.68|STANDARD_ERROR_OF_MEAN|0.404||0.105|TWO_SIDED|95.0|-1.504|0.151|||Kenward-Roger degree of freedom|Kenward-Roger degree of freedom is used to adjust the standard error of treatment effect|The modelled mean difference uses treatment sequence and difference of baselines as a covariates of the treatment effect.|||0.151|-1.504|0.105
72489737|NCT02495844|144507322|SUPERIORITY||Odds Ratio (OR)|4.14|||=|0.0679|TWO_SIDED|95.0|0.9|19.06|||Regression, Logistic|||||19.06|0.90|=0.0679
72516297|NCT03373110|144563593|OTHER|||||||0.597||||||A two-sided significance level of 0.05 was used for all analyses.|Mixed Models Analysis|||We used linear mixed effects models to examine the effect of the interventions on average daily steps at 16 weeks into the study. These models account for the covariance of repeated measurements within subjects, and we used maximum likelihood estimation to adjust for missing daily step counts. The models include a random intercept and fixed effects for intervention, time, and an intervention by time interaction.|We used linear mixed effects models to examine the effect of the interventions on daily steps. These models account for the covariance of repeated measurements within subjects, and we used maximum likelihood estimation to account for missing daily step counts. The models include a random intercept and fixed effects for intervention, time, and an intervention by time interaction.|||0.597
72516298|NCT01804036|144563615|SUPERIORITY_OR_OTHER|||||||0.84|||||||ANCOVA|||||||0.84
72516299|NCT01804036|144563616|SUPERIORITY_OR_OTHER|||||||0.11|||||||ANCOVA|||||||0.11
72516300|NCT01804036|144563617|SUPERIORITY_OR_OTHER|||||||0.95|||||||ANCOVA|||||||0.95
72516301|NCT01804036|144563618|SUPERIORITY_OR_OTHER|||||||0.08|||||||ANCOVA|||||||0.08
72516302|NCT01804036|144563619|SUPERIORITY_OR_OTHER|||||||0.2|||||||ANCOVA|||||||0.20
72624384|NCT02507934|144778678|SUPERIORITY||Mean Difference (Final Values)|8.56||||0.0129|TWO_SIDED|95.0|2.41|14.72||For each parameter, for each eye, an ANOVA model for repeated measures has been used by including each available timepoint. The estimated mean difference between treatments (Vismed-Lubricin) over time has been reported and tested.|repeated measures ANOVA|||Analysis of variance for repeated measures on Foreign body sensation - Left eye||14.72|2.41|0.0129
72404347|NCT00923559|144315469|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.84|STANDARD_ERROR_OF_MEAN|0.38||0.031|TWO_SIDED|95.0|-1.61|-0.08|||Regression, Linear|Degrees of freedom (df) = 61.2||see under the PIR-GAS||-0.08|-1.61|.031
72489738|NCT03118232|144507335|OTHER|The risk ratios reflect the risk of transfer to a hospital during the intervention period relative to the baseline period in each trial group.|Difference in Risk Ratio|16.6|||<|0.001|TWO_SIDED|95.0|11.0|21.8|||Mixed Models Analysis|||||21.8|11.0|<0.001
72489739|NCT03118232|144507336|OTHER|The risk ratios reflect the risk of transfer to a hospital during the intervention period relative to the baseline period in each trial group.|Difference in Risk Ratio|14.6|||<|0.001|TWO_SIDED|95.0|9.7|19.2|||Mixed Models Analysis|||||19.2|9.7|<0.001
72489740|NCT02325219|144507341|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||<0.001
72489741|NCT02325219|144507341|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||< 0.001
72489742|NCT02325219|144507342|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||<0.001
72489743|NCT02325219|144507342|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||< 0.001
72489744|NCT02918864|144507388|SUPERIORITY||Beta Coefficient|-0.22||||0.037|TWO_SIDED|||||p-value reported for Group\*Time, primary comparison in linear mixed effects model (SB=Group+Time+Group\*Time+ADHD+ γ + ε; ADHD, CASI T-score significant covariate), not adjusted for multiple tests (with different time points)|Mixed Models Analysis|||Ho=No significant interaction of Group\*Time||||0.037
72516303|NCT01804036|144563620|SUPERIORITY_OR_OTHER|||||||0.13|||||||ANCOVA|||||||0.13
72516304|NCT01804036|144563621|SUPERIORITY_OR_OTHER|||||||0.52|||||||ANCOVA|||||||0.52
72516305|NCT01804036|144563622|SUPERIORITY_OR_OTHER|||||||0.54|||||||ANCOVA|||||||0.54
72516306|NCT01804036|144563623|SUPERIORITY_OR_OTHER|||||||0.94|||||||ANCOVA|||||||0.94
72516307|NCT01804036|144563624|SUPERIORITY_OR_OTHER|||||||0.95|||||||ANCOVA|||||||0.95
72516308|NCT01804036|144563625|SUPERIORITY_OR_OTHER|||||||0.49|||||||ANCOVA|||||||0.49
72516309|NCT01804036|144563626|SUPERIORITY_OR_OTHER||||||<|0.01|||||||ANCOVA|||||||<0.01
72516310|NCT01804036|144563627|SUPERIORITY_OR_OTHER||||||<|0.01|||||||ANCOVA|||||||<0.01
72516311|NCT01804036|144563628|SUPERIORITY_OR_OTHER|||||||0.13|||||||ANCOVA|||||||0.13
72516312|NCT03483116|144563633|NON_INFERIORITY|Non-inferiority of the lower titre vaccine was demonstrated if the upper bound of the CI was below 20%.|Response rate|0.1553|||||TWO_SIDED|95.0|0.039|0.272||||||||0.272|0.039|
72568603|NCT04168190|144668502|OTHER|Geometric mean concentration (GMC) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMC Ratio|4.77|||||TWO_SIDED|95.0|2.69|8.45|||||Phase 1: V116 1.0 mL/Phase 1: Pneumovax™23|Serotype 23B||8.45|2.69|
72489745|NCT02918864|144507390|SUPERIORITY||Beta Coefficient|-0.23||||0.016|TWO_SIDED|||||p-value reported for Group\*Time, primary comparison in linear mixed effects model (SB=Group+Time+Group\*Time+ADHD+ γ + ε; ADHD, CASI T-score significant covariate), not adjusted for multiple tests (with different time points)|Mixed Models Analysis|||Ho=No significant interaction of Group\*Time||||0.016
72489746|NCT02918864|144507392|SUPERIORITY||Beta Coefficient|-0.16||||0.061|TWO_SIDED|||||p-value reported for Group\*Time, primary comparison in linear mixed effects model (SB=Group+Time+Group\*Time+ADHD+ γ + ε; ADHD, CASI T-score significant covariate), not adjusted for multiple tests (with different time points)|Mixed Models Analysis|||Ho=No significant interaction of Group\*Time||||0.061
72489747|NCT02918864|144507394|SUPERIORITY||Beta Coefficient|0.03||||0.674|TWO_SIDED|||||p-value reported for Group\*Time, primary comparison in linear mixed effects model (SC=Group+Time+Group\*Time+Group\*VIQ+ γ + ε; VIQ, verbal intelligence quotient (VIQ) significant moderator), not adjusted for multiple tests (with different time points)|Mixed Models Analysis|||Ho=No significant interaction of Group\*Time||||0.674
72489748|NCT02918864|144507396|SUPERIORITY||Beta Coefficient|0.09||||0.191|TWO_SIDED|||||p-value reported for Group\*Time, primary comparison in linear mixed effects model (SC=Group+Time+Group\*Time+Group\*VIQ+ γ + ε; VIQ, verbal intelligence quotient (VIQ) significant moderator), not adjusted for multiple tests (with different time points)|Mixed Models Analysis|||Ho=No significant interaction of Group\*Time||||0.191
72489749|NCT02918864|144507398|SUPERIORITY||Beta Coefficient|0.04||||0.599|TWO_SIDED|||||p-value reported for Group\*Time, primary comparison in linear mixed effects model (SC=Group+Time+Group\*Time+Group\*VIQ+ γ + ε; VIQ, verbal intelligence quotient (VIQ) significant moderator), not adjusted for multiple tests (with different time points)|Mixed Models Analysis|||H0=No significant interaction of Group\*Time||||0.599
72489750|NCT02918864|144507400|SUPERIORITY|||||||0.462||||||2-sided p-value; p-value reported not adjusted for multiple tests (with different time points)|Fisher Exact|||"Ho=Group and response are independent (responders=improved scores of 1-2; non-responders=worsened scores of 5-7 on the CGI-I) at week 12"||||0.462
72489751|NCT02918864|144507401|SUPERIORITY|||||||1||||||2-sided p-value; p-value reported not adjusted for multiple tests (with different time points)|Fisher Exact|||"Ho=Group and response are independent (responders=improved scores of 1-2; non-responders=worsened scores of 5-7 on the CGI-I) at week 16"||||1.000
72489752|NCT02918864|144507402|SUPERIORITY|||||||0.607||||||2-sided p-value; p-value reported not adjusted for multiple tests (with different time points)|Fisher Exact|||"Ho=Group and response are independent (responders=improved scores of 1-2; non-responders=worsened scores of 5-7 on the CGI-I) at week 24"||||0.607
72489753|NCT02918864|144507403|SUPERIORITY||Beta Coefficient|-0.15||||0.31|TWO_SIDED|||||p-value reported for Group\*Time, primary comparison in linear mixed effects model (SRS=Group+Time+Group\*Time+VIQ+ γ + ε; VIQ, verbal IQ significant covariate), not adjusted for multiple tests (with different time points)|Mixed Models Analysis|||Ho=No significant interaction of Group\*Time||||0.310
72489754|NCT02918864|144507405|SUPERIORITY||Beta Coefficient|-0.2||||0.115|TWO_SIDED|||||p-value reported for Group\*Time, primary comparison in linear mixed effects model (SRS=Group+Time+Group\*Time+VIQ+ γ + ε; VIQ, verbal IQ significant covariate), not adjusted for multiple tests (with different time points)|Mixed Models Analysis|||Ho=No significant interaction of Group\*Time||||0.115
72489755|NCT02918864|144507407|SUPERIORITY||Beta Coefficient|-0.08||||0.455|TWO_SIDED|||||p-value reported for Group\*Time, primary comparison in linear mixed effects model (SRS=Group+Time+Group\*Time+VIQ+ γ + ε; VIQ, verbal IQ significant covariate), not adjusted for multiple tests (with different time points)|Mixed Models Analysis|||Ho=No significant interaction of Group\*Time||||0.455
72489756|NCT02918864|144507409|SUPERIORITY||Beta Coefficient|-0.14||||0.379|TWO_SIDED|||||p-value reported for Group\*Time, primary comparison in linear mixed effects model (CGS=Group+Time+Group\*Time+ γ + ε), not adjusted for multiple tests (with different time points)|Mixed Models Analysis|||Ho=No significant interaction of Group\*Time||||0.379
72489757|NCT02918864|144507411|SUPERIORITY||Beta Coefficient|-0.14||||0.275|TWO_SIDED|||||p-value reported for Group\*Time, primary comparison in linear mixed effects model (CGS=Group+Time+Group\*Time+ γ + ε), not adjusted for multiple tests (with different time points)|Mixed Models Analysis|||Ho=No significant interaction of Group\*Time||||0.275
72489758|NCT02918864|144507413|SUPERIORITY||Beta Coefficient|-0.2||||0.087|TWO_SIDED|||||p-value reported for Group\*Time, primary comparison in linear mixed effects model (CGS=Group+Time+Group\*Time+ γ + ε), not adjusted for multiple tests (with different time points)|Mixed Models Analysis|||||||0.087
72489759|NCT02634151|144507432|SUPERIORITY||LS Mean Difference|-11.05||||0.0057|TWO_SIDED|95.0|-18.81|-3.29|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||A 2-sided test with a significance level of 0.05 was used for the comparison.||-3.29|-18.81|0.0057
72489760|NCT02634151|144507433|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-11.8||||0.0648|TWO_SIDED|95.0|-24.35|0.75|||ANCOVA|Randomized treatment group and baseline diabetes status are included as factors, and the outcome at baseline is included as a covariate.||High-Intensity.||0.75|-24.35|0.0648
72489761|NCT02634151|144507433|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-10.64||||0.0398|TWO_SIDED|95.0|-20.77|-0.51|||ANCOVA|Randomized treatment group and baseline diabetes status are included as factors, and the outcome at baseline is included as a covariate.||Moderate Intensity.||-0.51|-20.77|0.0398
72516313|NCT03483116|144563633|NON_INFERIORITY|Non-inferiority of the lower titre vaccine was demonstrated if the upper bound of the CI was below 20%|Response rate|0.001|||||TWO_SIDED|95.0|-0.115|0.117||||||||0.117|-0.115|
72516314|NCT03483116|144563633|NON_INFERIORITY|Non-inferiority of the lower titre vaccine was demonstrated if the upper bound of the CI was below 20%|Difference Response rate|0.1543|||||TWO_SIDED|95.0|0.038|0.27||||||Non-inferiority of the lower titre vaccine was demonstrated if the upper bound of the CI was below 20%||0.270|0.038|
72404348|NCT00923559|144315470|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.13|STANDARD_ERROR_OF_MEAN|0.09||0.158|TWO_SIDED|95.0|-0.05|0.31|||Mixed Models Analysis|Degrees of freedom (df) = 71.2||Null hypothesis: MIP and CHC care should yield equal outcomes. For power calculations, studies on the EPDS and the SPSQ were used. An estimated power of .80 and a two-tailed significance of .05 would necessitate between 29 and 60 participants. Forty dyads per group were chosen.||0.31|-0.05|.158
72404349|NCT04258605|144315481|OTHER|P-values account for preoperative versus postoperative mean values at 1 and 2 years|||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||"The small sample size of arm ASHCOM Shoulder System subjects - Fracture humeral stem of 2 cases is too low for a statistical analysis."||||<.0001
72404350|NCT04258605|144315482|OTHER|P-values account for preoperative versus postoperative mean values at 3-6 months, 1 year, 2 and 3 years|||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||"The small sample size of arm ASHCOM Shoulder System subjects - Fracture humeral stem of 2 cases is too low for a statistical analysis."||||<0.001
72404351|NCT04258605|144315483|OTHER|P-values account for preoperative versus postoperative mean values at 3-6 months, 1, 2 and 3 years|||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||"The small sample size of arm ASHCOM Shoulder System subjects - Fracture humeral stem of 2 cases is too low for a statistical analysis."||||<0.001
72404352|NCT04258605|144315484|OTHER|P-values account for preoperative versus postoperative mean values at 3-6 months, 1 year, 2 and 3 years|||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||"The small sample size of arm ASHCOM Shoulder System subjects - Fracture humeral stem of 2 cases is too low for a statistical analysis."||||<0.001
72404353|NCT00962104|144315496|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-5.78|||<|0.001|TWO_SIDED|95.0|-7.66|-3.91||Statistical significance was assessed using an analysis of covariance (ANCOVA) with term for treatment, country, and baseline CAARS-Inv:SV 18-Item Total ADHD Symptom score .|ANCOVA|||||-3.91|-7.66|<0.001
72489762|NCT02634151|144507434|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-10.09||||0.0275|TWO_SIDED|95.0|-19.04|-1.14|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 2||-1.14|-19.04|0.0275
72489763|NCT02634151|144507434|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-9.4||||0.0524|TWO_SIDED|95.0|-18.9|0.1|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 4.||0.10|-18.90|0.0524
72516315|NCT01181102|144563643|NON_INFERIORITY_OR_EQUIVALENCE|"(non-inferiority) When analyzed using the Z test at a one-sided 0.025 significance level, with the addition of a non-inferiority margin of 5% to the incidence in the enoxaparin group.~(superiority) The incidence of thromboembolic events for the FAS was compared using the χ2 test (two-sided significance level: 0.05)"|Cox Proportional Hazard|-6.5|||<|0.001|TWO_SIDED|95.0|-11.5|-1.6||non-inferiority:P \< 0.001 superiority:P = 0.010|non-inferiority:Z test. superiority:χ2 t|||The incidence proportion of thromboembolic events in the DU-176b group (P˅DU) = The incidence proportion of thromboembolic events in the enoxaparin group (P˅E) + Δ (5%). Alternative hypothesis H˅11: P˅DU \< P˅E + Δ (level of significance, 0.025; one-sided). If the null hypothesis H˅01 was rejected, the following analysis had to be sequentially performed using the χ2 test statistic. Null hypothesis H˅02: P˅DU = P˅E Alternative hypothesis H˅12: P˅DU ≠ P˅E (level of significance, 0.05; two-sided).||-1.6|-11.5|<0.001
72516316|NCT01181102|144563644|SUPERIORITY_OR_OTHER||χ2 test|2.5|||||TWO_SIDED|95.0|-0.8|5.9||||||||5.9|-0.8|
72516317|NCT02940626|144563689|OTHER|||||||0.547|||||||Wald Test on equality of proportions|||Subjects were analyzed for efficacy in the group to which they randomized. Sponsor defined outcomes were based on review of microbiology results from samples tested at the central lab. If sample was not sent to the central lab., determination was based on results from the local microbiology lab. In cases where both local \& central lab results were available, concordance was confirmed for S. aureus. Therefore, the analysis used local microbiology data in order to utilize a more complete dataset.||||.5470
72516318|NCT05127421|144563705|SUPERIORITY||Odds Ratio (OR)|2.81||||0.091|TWO_SIDED|95.0|0.83|9.47|||Cochran-Mantel-Haenszel|stratified by the stratification factor (face and/or neck Investigator's Global Assessment \[IGA\] score of 2 or 3 at screening).||||9.47|0.83|0.091
72516319|NCT05127421|144563705|SUPERIORITY||response rate difference|19.5|STANDARD_ERROR_OF_MEAN|10.23|||TWO_SIDED|95.0|-0.5|39.6|||||The 95% confidence interval was computed based on a large-sample normal approximation with continuity correction.|||39.6|-0.5|
72516320|NCT03488914|144563719|SUPERIORITY||Slope|-1.09||||0.19|TWO_SIDED|95.0|-2.78|0.56|||negative binomial regression|Model testing whether condition predicted illicit drug use days at 3-months||||.56|-2.78|.19
72404354|NCT00962104|144315497|SUPERIORITY_OR_OTHER||Slope|4.76|||<|0.001|TWO_SIDED|95.0|1.97|7.56||First gated secondary outcome measure. A gatekeeper strategy (Westfall and Krishen 2001) controlled experiment-wise type I error for 2 QoL measures. Treatments were compared stepwise until an outcome failed to be significant (p\>0.05).|ANCOVA|Statistical significance was assessed using an analysis of covariance (ANCOVA) with term for treatment, country, and baseline AAQoL total score.||||7.56|1.97|<0.001
72404355|NCT00962104|144315498|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-1.82||||0.289|TWO_SIDED|95.0|-5.2|1.56||Second gated secondary outcome measure. A gatekeeper strategy (Westfall and Krishen 2001) controlled experiment-wise type I error for 2 QoL measures. Treatments were compared stepwise until an outcome failed to be significant (p\>0.05).|ANCOVA|Least Squares Mean difference between 2 treatment groups from Type III sum of squares analysis of covariance model:Change=treatment+country+baseline.||||1.56|-5.20|0.289
72404356|NCT00962104|144315499|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-6.18|||<|0.001|TWO_SIDED|95.0|-8.13|-4.22|||Mixed Models Analysis|||||-4.22|-8.13|<0.001
72404357|NCT00962104|144315500|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-6.18|||<|0.001|TWO_SIDED|95.0|-8.21|-4.14|||Mixed Models Analysis|||||-4.14|-8.21|<0.001
72489764|NCT02634151|144507434|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|0.89||||0.8602|TWO_SIDED|95.0|-9.12|10.9|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 8||10.90|-9.12|0.8602
72404358|NCT00962104|144315501|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-3.59||||0.001|TWO_SIDED|95.0|-5.73|-1.45||This is the p-value for the Raw Behavioral Regulation Index score. Statistical significance was assessed using an analysis of covariance (ANCOVA) with term for treatment, country, and baseline value.|ANCOVA|||||-1.45|-5.73|0.001
72404359|NCT00962104|144315501|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-6.29|||<|0.001|TWO_SIDED|95.0|-9.28|-3.31||This is the p-value for the Raw MI score. Statistical significance was assessed using an analysis of covariance (ANCOVA) with term for treatment, country, and baseline value.|ANCOVA|||||-3.31|-9.28|<0.001
72404360|NCT00962104|144315501|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-9.76|||<|0.001|TWO_SIDED|95.0|-14.75|-4.78||This is the p-value for the Global Executive Composite Index score. Statistical significance was assessed using an analysis of covariance (ANCOVA) with term for treatment, country, and baseline value.|ANCOVA|||||-4.78|-14.75|<0.001
72489765|NCT02634151|144507434|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-12.63||||0.0115|TWO_SIDED|95.0|-22.37|-2.89|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 12||-2.89|-22.37|0.0115
72489766|NCT02634151|144507434|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-5.87||||0.1945|TWO_SIDED|95.0|-14.79|3.05|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Average of week 8 and 12||3.05|-14.79|0.1945
72489767|NCT02634151|144507435|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-5.88||||0.0991|TWO_SIDED|95.0|-12.89|1.13|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||||1.13|-12.89|0.0991
72489768|NCT02634151|144507436|OTHER|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-7.58||||0.0101|TWO_SIDED|95.0|-13.32|-1.84|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 2||-1.84|-13.32|0.0101
72489769|NCT02634151|144507436|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-9.56||||0.0037|TWO_SIDED|95.0|-15.94|-3.18|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 4||-3.18|-15.94|0.0037
72489770|NCT02634151|144507436|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-0.94||||0.7839|TWO_SIDED|95.0|-7.72|5.84|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 8||5.84|-7.72|0.7839
72516321|NCT03488914|144563719|SUPERIORITY||negative binomial regression|-1.66||||0.12|TWO_SIDED|95.0|-3.78|0.48|||negative binomial regression|Model testing whether condition predicted illicit drug use days at 6-months||||.48|-3.78|.12
72516322|NCT03488914|144563719|SUPERIORITY||Slope|0.01||||0.99|TWO_SIDED|95.0|-2.05|2.07|||negative binomial regression|Model testing whether condition predicted illicit drug use days at 9-months||||2.07|-2.05|.99
72516323|NCT03488914|144563719|SUPERIORITY||Slope|-0.78||||0.42|TWO_SIDED|95.0|-2.67|1.11|||negative binomial regression|Model testing whether condition predicted illicit drug use days at 12-months||||1.11|-2.67|.42
72516324|NCT03488914|144563719|SUPERIORITY||Slope|-1.09||||0.18|TWO_SIDED|95.0|-2.69|0.51|||negative binomial regression|Model testing whether condition predicted illicit drug use days at 15-months||||.51|-2.69|.18
72516325|NCT03488914|144563720|SUPERIORITY||Slope|0.03||||0.96|TWO_SIDED|95.0|-0.86|0.99|||negative binomial regression|Model testing whether condition predicted condomless anal sex acts at 3-months||||.99|-.86|.96
72404361|NCT00962104|144315502|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-1.93||||0.092|TWO_SIDED|95.0|-4.18|0.32||This is the p-value for the Raw Behavioral Regulation Index score. Statistical significance was assessed using an analysis of covariance (ANCOVA) with term for treatment, country, and baseline value.|ANCOVA|||||0.32|-4.18|0.092
72404362|NCT00962104|144315502|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-1.62||||0.272|TWO_SIDED|95.0|-4.52|1.28||This is the p-value for the Raw MI Index score. Statistical significance was assessed using an analysis of covariance (ANCOVA) with term for treatment, country, and baseline value.|ANCOVA|||||1.28|-4.52|0.272
72489771|NCT02634151|144507436|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-10.69||||0.0025|TWO_SIDED|95.0|-17.53|-3.84|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 12||-3.84|-17.53|0.0025
72489772|NCT02634151|144507437|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-12.66||||0.0117|TWO_SIDED|95.0|-22.45|-2.88|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 2||-2.88|-22.45|0.0117
72489773|NCT02634151|144507437|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-15.55||||0.0036|TWO_SIDED|95.0|-25.88|-5.21|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 4||-5.21|-25.88|0.0036
72489774|NCT02634151|144507437|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-0.59||||0.9147|TWO_SIDED|95.0|-11.48|10.31||Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.|ANCOVA|||Week 8||10.31|-11.48|0.9147
72516326|NCT03488914|144563720|SUPERIORITY||Slope|-1.19||||0.03|TWO_SIDED|95.0|-2.25|-0.14|||negative binomial regression|Model testing whether condition predicted condomless anal sex acts at 6-months||||-.14|-2.25|.03
72516327|NCT03488914|144563720|SUPERIORITY||Slope|0.13||||0.79|TWO_SIDED|95.0|-0.83|1.1|||negative binomial regression|Model testing whether condition predicted condomless anal sex acts at 9-months||||1.10|-.83|.79
72516328|NCT03488914|144563720|SUPERIORITY||Slope|0.06||||0.91|TWO_SIDED|95.0|-0.99|1.11|||negative binomial regression|Model testing whether condition predicted condomless anal sex acts at 12-months||||1.11|-.99|.91
72516329|NCT03488914|144563720|SUPERIORITY||Slope|-0.42||||0.44|TWO_SIDED|95.0|-1.5|0.65|||negative binomial regression|Model testing whether condition predicted condomless anal sex acts at 15-months||||.65|-1.50|.44
72489775|NCT02634151|144507437|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-16.59||||0.0026|TWO_SIDED|95.0|-27.24|-5.93|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 12||-5.93|-27.24|0.0026
72489776|NCT02634151|144507438|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-6.13||||0.0101|TWO_SIDED|95.0|-10.77|-1.5|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 2||-1.50|-10.77|0.0101
72489777|NCT02634151|144507438|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-7.73||||0.0036|TWO_SIDED|95.0|-12.89|-2.58|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 4||-2.58|-12.89|0.0036
72489778|NCT02634151|144507438|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|0.12||||0.9653|TWO_SIDED|95.0|-5.27|5.51|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 8||5.51|-5.27|0.9653
72489779|NCT02634151|144507438|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-6.89||||0.0101|TWO_SIDED|95.0|-12.1|-1.68|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 12||-1.68|-12.10|0.0101
72489780|NCT02634151|144507439|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-12.74||||0.0173|TWO_SIDED|95.0|-23.19|-2.3|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 2||-2.30|-23.19|0.0173
72489781|NCT02634151|144507439|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-16.29||||0.0038|TWO_SIDED|95.0|-27.17|-5.4|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 4||-5.40|-27.17|0.0038
72489782|NCT02634151|144507439|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|1.58||||0.7846|TWO_SIDED|95.0|-9.85|13.01|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 8||13.01|-9.85|0.7846
72489783|NCT02634151|144507439|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-13.98||||0.0121|TWO_SIDED|95.0|-24.83|-3.13|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 12||-3.13|-24.83|0.0121
72516330|NCT03488914|144563721|SUPERIORITY||Slope|-0.26||||0.54|TWO_SIDED|95.0|-1.09|0.58|||negative binomial regression|Model testing whether condition predicted marijuana use days at 3-months||||.58|-1.09|.54
72489784|NCT02634151|144507440|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-13.32||||0.0108|TWO_SIDED|95.0|-23.32|-3.12|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 2||-3.12|-23.32|0.0108
72516331|NCT03488914|144563721|SUPERIORITY||Slope|0.38||||0.49|TWO_SIDED|95.0|-0.7|1.46|||negative binomial regression|Model testing whether condition predicted marijuana use days at 6-months||||1.46|-.70|.49
72516332|NCT03488914|144563721|SUPERIORITY||Slope|-0.26||||0.59|TWO_SIDED|95.0|-1.18|0.66|||negative binomial regression|Model testing whether condition predicted marijuana use days at 9-months||||.66|-1.18|.59
72516333|NCT03488914|144563721|SUPERIORITY||Slope|0.26||||0.65|TWO_SIDED|95.0|-0.86|1.37|||negative binomial regression|Model testing whether condition predicted marijuana use days at 12-months||||1.37|-.86|.65
72516334|NCT03488914|144563721|SUPERIORITY||Slope|-0.36||||0.49|TWO_SIDED|95.0|-1.4|0.67|||negative binomial regression|Model testing whether condition predicted marijuana use days at 15-months||||.67|-1.40|.49
72489785|NCT02634151|144507440|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-23.6|||<|0.0001|TWO_SIDED|95.0|-34.78|-12.42|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 4||-12.42|-34.78|<0.0001
72489786|NCT02634151|144507440|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-6.71||||0.1376|TWO_SIDED|95.0|-15.6|2.18|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 8||2.18|-15.60|0.1376
72489787|NCT02634151|144507440|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-15.64||||0.0144|TWO_SIDED|95.0|-28.1|-3.18|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||||-3.18|-28.10|0.0144
72489788|NCT02634151|144507441|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-19.53||||0.0113|TWO_SIDED|95.0|-34.55|-4.51|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 2||-4.51|-34.55|0.0113
72489789|NCT02634151|144507441|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-33.64||||0.0002|TWO_SIDED|95.0|-50.58|-16.69|||ANCOVA|||Week 4||-16.69|-50.58|0.0002
72489790|NCT02634151|144507441|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-8.33||||0.1873|TWO_SIDED|95.0|-20.77|4.12|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 8||4.12|-20.77|0.1873
72516335|NCT03488914|144563722|SUPERIORITY||Slope|-0.36||||0.31|TWO_SIDED|995.0|-1.07|0.34|||negative binomial regression|Model testing whether condition predicted alcohol use days at 3-months||||.34|-1.07|.31
72489791|NCT02634151|144507441|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-29.58||||0.0172|TWO_SIDED|95.0|-53.8|-5.37|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 12||-5.37|-53.80|0.0172
72404363|NCT00962104|144315502|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-3.55||||0.153|TWO_SIDED|95.0|-8.43|1.32||This is the p-value for the Raw Global Executive Composite Index score. Statistical significance was assessed using an analysis of covariance (ANCOVA) with term for treatment, country, and baseline value.|ANCOVA|||||1.32|-8.43|0.153
72404364|NCT00962104|144315503|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.47|||<|0.001|TWO_SIDED|95.0|-0.67|-0.27||Statistical significance was assessed using an analysis of covariance (ANCOVA) with term for treatment, country, and baseline value.|ANCOVA|||||-0.27|-0.67|<0.001
72489792|NCT02634151|144507442|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-11.52||||0.021|TWO_SIDED|95.0|-21.27|-1.77|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 2||-1.77|-21.27|0.0210
72489793|NCT02634151|144507442|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-23.01|||<|0.0001|TWO_SIDED|95.0|-34.02|-12.01|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 4||-12.01|-34.02|<0.0001
72489794|NCT02634151|144507442|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-6.43||||0.1483|TWO_SIDED|95.0|-15.19|2.33|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 8||2.33|-15.19|0.1483
72489795|NCT02634151|144507442|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-11.63||||0.0214|TWO_SIDED|95.0|-21.5|-1.76|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 12||-1.76|-21.50|0.0214
72489796|NCT02634151|144507443|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-2.95||||0.0308|TWO_SIDED|95.0|-5.62|-0.28|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 2||-0.28|-5.62|0.0308
72516336|NCT03488914|144563722|SUPERIORITY||Slope|-0.71||||0.1|TWO_SIDED|95.0|-1.57|0.15|||negative binomial regression|Model testing whether condition predicted alcohol use days at 6-months||||.15|-1.57|.10
72516337|NCT03488914|144563722|SUPERIORITY||Slope|-0.53||||0.2|TWO_SIDED|95.0|-1.34|0.28|||negative binomial regression|Model testing whether condition predicted alcohol use days at 9-months||||.28|-1.34|.20
72516338|NCT03488914|144563722|SUPERIORITY||Slope|-0.25||||0.58|TWO_SIDED|95.0|-1.14|0.64|||negative binomial regression|Model testing whether condition predicted alcohol use days at 12-months||||.64|-1.14|.58
72404365|NCT00962104|144315504|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical significance was assessed using an analysis of variance (ANOVA) with term for treatment and country.|ANOVA|||||||<0.001
72404366|NCT00962104|144315505|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.05||||0.869|TWO_SIDED|95.0|-0.71|0.6||Statistical significance was assessed using an analysis of covariance (ANCOVA) with term for treatment, country, and baseline value.|ANCOVA|||||0.60|-0.71|0.869
72516339|NCT03488914|144563722|SUPERIORITY||Slope|-0.45||||0.34|TWO_SIDED|95.0|-1.37|0.47|||negative binomial regression|Model testing whether condition predicted alcohol use days at 15-months||||.47|-1.37|.34
72404367|NCT00962104|144315506|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.05||||0.87|TWO_SIDED|95.0|-0.59|0.5||Statistical significance was assessed using an analysis of covariance (ANCOVA) with term for treatment, country, and baseline value.|ANCOVA|||||0.50|-0.59|0.870
72404368|NCT02013167|144315507|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.71||||0.012|TWO_SIDED|95.0|0.55|0.93|||Stratified Log Rank|Stratified by age (\< 35 years; ≥ 35 years), prior salvage therapy (yes vs. no), and prior allogeneic HSCT (yes vs. no).|Hazard ratio obtained from the Cox Proportional Hazard Model. A hazard ratio \< 1.0 indicated a lower average event rate and longer survival time for blinatumomab relative to SOC chemotherapy.|||0.93|0.55|0.012
72489797|NCT02634151|144507443|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-6.3||||0.0002|TWO_SIDED|95.0|-9.56|-3.04|||ANCOVA|A 2-sided test with a significance level of 0.05 was used for the comparison.||Week 4||-3.04|-9.56|0.0002
72489798|NCT02634151|144507443|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-1.58||||0.2056|TWO_SIDED|95.0|-4.03|0.88|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 8||0.88|-4.03|0.2056
72516340|NCT01802554|144563723|SUPERIORITY_OR_OTHER|||||||0.039|||||||Mixed Models Analysis|||||||.039
72516341|NCT01802554|144563724|SUPERIORITY_OR_OTHER|||||||0.701|||||||Mixed Models Analysis|||||||.701
72516342|NCT01802554|144563725|SUPERIORITY_OR_OTHER|||||||0.04|||||||Mixed Models Analysis|||||||.04
72516343|NCT01802554|144563726|SUPERIORITY_OR_OTHER|||||||0.268|||||||Mixed Models Analysis|||||||.268
72489799|NCT02634151|144507443|SUPERIORITY||LS Mean Difference|-4.0||||0.0103|TWO_SIDED|95.0|-7.04|-0.96|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 12||-0.96|-7.04|0.0103
72489800|NCT02634151|144507444|SUPERIORITY||LS Mean Difference|-2.13||||0.3193|TWO_SIDED|95.0|-6.36|2.09|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||||2.09|-6.36|0.3193
72516344|NCT01802554|144563727|SUPERIORITY_OR_OTHER|||||||0.021|||||||Mixed Models Analysis|||||||.021
72489801|NCT02634151|144507444|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-2.4||||0.2932|TWO_SIDED|95.0|-6.91|2.11|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 4||2.11|-6.91|0.2932
72489802|NCT02634151|144507444|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|1.98||||0.4383|TWO_SIDED|95.0|-3.06|7.02|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 8||7.02|-3.06|0.4383
72489803|NCT02634151|144507444|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|2.78||||0.2814|TWO_SIDED|95.0|-2.31|7.86|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 12||7.86|-2.31|0.2814
72489804|NCT02634151|144507445|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-0.92||||0.4278|TWO_SIDED|95.0|-3.23|1.38|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 2||1.38|-3.23|0.4278
72489805|NCT02634151|144507445|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-1.13||||0.3529|TWO_SIDED|95.0|-3.53|1.27|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 4||1.27|-3.53|0.3529
72489806|NCT02634151|144507445|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|1.24||||0.3522|TWO_SIDED|95.0|-1.39|3.86|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 8||3.86|-1.39|0.3522
72489807|NCT02634151|144507445|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|1.6||||0.2635|TWO_SIDED|95.0|-1.22|4.42|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 12||4.42|-1.22|0.2635
72489808|NCT02634151|144507446|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|Odds Ratio (OR)|2.23||||0.0464|TWO_SIDED|95.0|1.01|4.93|||Regression, Logistic|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 4||4.93|1.01|0.0464
72489809|NCT02634151|144507446|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|Odds Ratio (OR)|1.3||||0.5278|TWO_SIDED|95.0|0.58|2.92|||Regression, Logistic|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 8||2.92|0.58|0.5278
72516345|NCT02659605|144563741|EQUIVALENCE|The sample size was based on a previous study by Rabe et al. (Obstet Gynecol. 2011;117(2 Pt 1):205-11), who were also evaluating neonatal hematocrit after delayed cord clamping with the intention of detecting a 10% difference with a p-value of 0.05 and a power of 80% for a two-sided t-test. That study determined that 26 patients in each group were needed for a total of 52 subjects.||||||0.572|||||||Student's t-test|||||||0.572
72404369|NCT02013167|144315508|SUPERIORITY_OR_OTHER_LEGACY||Treatment difference|17.9|||<|0.001|TWO_SIDED|95.0|9.6|26.2|||Cochran-Mantel-Haenszel|Adjusted for the stratification factors: age (\< 35 vs. ≥ 35), prior salvage therapy (yes vs. no), and prior allogeneic HSCT (yes vs. no).||||26.2|9.6|< 0.001
72404370|NCT02013167|144315509|SUPERIORITY_OR_OTHER_LEGACY||Treatment difference|19.3|||<|0.001|TWO_SIDED|95.0|9.9|28.7|||Cochran-Mantel-Haenszel|Adjusted for the stratification factors: age (\< 35 vs. ≥ 35), prior salvage therapy (yes vs. no), and prior allogeneic HSCT (yes vs. no).||||28.7|9.9|< 0.001
72404371|NCT02013167|144315510|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.55|||||TWO_SIDED|95.0|0.43|0.71|||||The hazard ratio estimates were obtained from the Cox Proportional Hazard Model. A hazard ratio \< 1.0 indicates a lower average event rate and a longer survival for Blinatumomab relative to SOC Chemotherapy.|||0.71|0.43|
72404372|NCT01113879|144315522|OTHER||||||<|0.001|TWO_SIDED|85.0|||||Weighted Tau U|||Weighted Tau U effect size mean values in Block 1 of treatment (no aerobic exercise or stretching) were compared to weighted Tau U mean values in Block 2 of treatment (aerobic exercise or stretching adjuvant).||||< 0.001
72489810|NCT02634151|144507446|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|Odds Ratio (OR)|2.36||||0.0359|TWO_SIDED|95.0|1.06|5.27|||Regression, Logistic|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 12||5.27|1.06|0.0359
72489811|NCT02634151|144507447|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|Odds Ratio (OR)|2.5||||0.0268|TWO_SIDED|95.0|1.11|5.61|||Regression, Logistic|||Week 4||5.61|1.11|0.0268
72489812|NCT02634151|144507447|SUPERIORITY||Odds Ratio (OR)|1.55||||0.2755|TWO_SIDED|95.0|0.7|3.41|||Regression, Logistic|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 8||3.41|0.70|0.2755
72489813|NCT02634151|144507447|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|Odds Ratio (OR)|4.74||||0.0003|TWO_SIDED|95.0|2.05|10.94|||Regression, Logistic|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 12||10.94|2.05|0.0003
72489814|NCT02634151|144507448|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|Odds Ratio (OR)|3.26||||0.0079|TWO_SIDED|95.0|1.36|7.8|||Regression, Logistic|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 4||7.80|1.36|0.0079
72489815|NCT02634151|144507448|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|Odds Ratio (OR)|1.44||||0.4002|TWO_SIDED|95.0|0.62|3.35|||Regression, Logistic|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 8||3.35|0.62|0.4002
72489816|NCT02634151|144507448|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|Odds Ratio (OR)|3.09||||0.0142|TWO_SIDED|95.0|1.25|7.59|||Regression, Logistic|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 12||7.59|1.25|0.0142
72489817|NCT02634151|144507449|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|Odds Ratio (OR)|3.7||||0.0115|TWO_SIDED|95.0|1.34|10.2|||Regression, Logistic|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 4||10.20|1.34|0.0115
72489818|NCT02634151|144507449|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|Odds Ratio (OR)|1.15||||0.7566|TWO_SIDED|95.0|0.48|2.75|||Regression, Logistic|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 8||2.75|0.48|0.7566
72489819|NCT02634151|144507449|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|Odds Ratio (OR)|2.96||||0.0298|TWO_SIDED|95.0|1.11|7.88|||Regression, Logistic|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 12||7.88|1.11|0.0298
72489820|NCT02634151|144507450|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-10.4||||0.0029|TWO_SIDED|95.0|-17.2|-3.7|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 4||-3.7|-17.2|0.0029
72489821|NCT02634151|144507450|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-4.3||||0.1666|TWO_SIDED|95.0|-10.4|1.8|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 8||1.8|-10.4|0.1666
72489822|NCT02634151|144507450|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-11.5||||0.001|TWO_SIDED|95.0|-18.2|-4.8|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 12||-4.8|-18.2|0.0010
72489823|NCT02634151|144507451|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-10.7||||0.0018|TWO_SIDED|95.0|-17.3|-4.1|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 4||-4.1|-17.3|0.0018
72489824|NCT02634151|144507451|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-3.8||||0.2437|TWO_SIDED|95.0|-10.1|2.6|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 8||2.6|-10.1|0.2437
72516346|NCT02659605|144563742|EQUIVALENCE|The sample size was based on a previous study by Rabe et al. (Obstet Gynecol. 2011;117(2 Pt 1):205-11), who were also evaluating neonatal hematocrit after delayed cord clamping with the intention of detecting a 10% difference with a p-value of 0.05 and a power of 80% for a two-sided t-test. That study determined that 26 patients in each group were needed for a total of 52 subjects.||||||0.849|||||||Student's t-test|||||||0.849
72516347|NCT02659605|144563743|EQUIVALENCE|The sample size was based on a previous study by Rabe et al. (Obstet Gynecol. 2011;117(2 Pt 1):205-11), who were also evaluating neonatal hematocrit after delayed cord clamping with the intention of detecting a 10% difference with a p-value of 0.05 and a power of 80% for a two-sided t-test. That study determined that 26 patients in each group were needed for a total of 52 subjects.||||||0.886|||||||Student's t-test|||||||0.886
72568604|NCT04168190|144668502|OTHER|Geometric mean concentration (GMC) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMC Ratio|8.06|||||TWO_SIDED|95.0|3.36|19.35|||||Phase 1: V116 0.5 mL/Phase 1: Pneumovax™23|Serotype 24F||19.35|3.36|
72489825|NCT02634151|144507451|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-11.6||||0.0012|TWO_SIDED|95.0|-18.5|-4.7|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 12||-4.7|-18.5|0.0012
72489826|NCT02634151|144507452|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-0.7||||0.6832|TWO_SIDED|95.0|-4.2|2.8|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 4||2.8|-4.2|0.6832
72489827|NCT02634151|144507452|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|0.8||||0.674|TWO_SIDED|95.0|-2.9|4.5|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 8||4.5|-2.9|0.6740
72489828|NCT02634151|144507452|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|1.9||||0.3379|TWO_SIDED|95.0|-2.0|5.7|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 12||5.7|-2.0|0.3379
72489829|NCT02634151|144507453|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-0.7||||0.7753|TWO_SIDED|95.0|-5.9|4.4|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 4||4.4|-5.9|0.7753
72489830|NCT02634151|144507453|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|1.7||||0.5472|TWO_SIDED|95.0|-3.9|7.4|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 8||7.4|-3.9|0.5472
72489831|NCT02634151|144507453|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|3.6||||0.2406|TWO_SIDED|95.0|-2.4|9.6|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 12||9.6|-2.4|0.2406
72489832|NCT02634151|144507454|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|0.2||||0.9028|TWO_SIDED|95.0|-3.3|3.8|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 4||3.8|-3.3|0.9028
72489833|NCT02634151|144507454|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|5.2||||0.0199|TWO_SIDED|95.0|0.8|9.6|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 8||9.6|0.8|0.0199
72489834|NCT02634151|144507454|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|4.6||||0.0369|TWO_SIDED|95.0|0.3|8.9|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 12||8.9|0.3|0.0369
72489835|NCT02634151|144507455|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|0.1||||0.911|TWO_SIDED|95.0|-1.2|1.4|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 4||1.4|-1.2|0.9110
72489836|NCT02634151|144507455|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|1.9||||0.0243|TWO_SIDED|95.0|0.3|3.5|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 8||3.5|0.3|0.0243
72489837|NCT02634151|144507455|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|1.7||||0.0388|TWO_SIDED|95.0|0.1|3.2|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 12||3.2|0.1|0.0388
72489838|NCT02634151|144507456|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|7.0||||0.2799|TWO_SIDED|95.0|-5.7|19.6|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 4||19.6|-5.7|0.2799
72489839|NCT02634151|144507456|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|26.8||||0.0018|TWO_SIDED|95.0|10.2|43.3|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 8||43.3|10.2|0.0018
72489840|NCT02634151|144507456|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|20.1||||0.0197|TWO_SIDED|95.0|3.3|36.9|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 12||36.9|3.3|0.0197
72516348|NCT02659605|144563744|EQUIVALENCE|The sample size was based on a previous study by Rabe et al. (Obstet Gynecol. 2011;117(2 Pt 1):205-11), who were also evaluating neonatal hematocrit after delayed cord clamping with the intention of detecting a 10% difference with a p-value of 0.05 and a power of 80% for a two-sided t-test. That study determined that 26 patients in each group were needed for a total of 52 subjects.||||||0.612|||||||Student's t-test|||||||0.612
72516349|NCT02659605|144563745|EQUIVALENCE|The sample size was based on a previous study by Rabe et al. (Obstet Gynecol. 2011;117(2 Pt 1):205-11), who were also evaluating neonatal hematocrit after delayed cord clamping with the intention of detecting a 10% difference with a p-value of 0.05 and a power of 80% for a two-sided t-test. That study determined that 26 patients in each group were needed for a total of 52 subjects.||||||0.728|||||||Student's t-test|||||||0.728
72516350|NCT02659605|144563746|EQUIVALENCE|The sample size was based on a previous study by Rabe et al. (Obstet Gynecol. 2011;117(2 Pt 1):205-11), who were also evaluating neonatal hematocrit after delayed cord clamping with the intention of detecting a 10% difference with a p-value of 0.05 and a power of 80% for a two-sided t-test. That study determined that 26 patients in each group were needed for a total of 52 subjects.||||||0.584|||||||Student's t-test|||||||0.584
72516351|NCT01512108|144563780|SUPERIORITY_OR_OTHER||Estimated treatment difference, Mean|-0.27||||0.0026||95.0|-0.44|-0.09|||ANOVA|||||-0.09|-0.44|0.0026
72489841|NCT02634151|144507457|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|0.6||||0.0179|TWO_SIDED|95.0|0.1|1.0|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 4||1.0|0.1|0.0179
72489842|NCT02634151|144507457|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|1.1||||0.0003|TWO_SIDED|95.0|0.5|1.7|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 8||1.7|0.5|0.0003
72489843|NCT02634151|144507457|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|0.8||||0.0095|TWO_SIDED|95.0|0.2|1.5|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 12||1.5|0.2|0.0095
72489844|NCT02634151|144507458|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-12.2||||0.0057|TWO_SIDED|95.0|-20.8|-3.6|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 4||-3.6|-20.8|0.0057
72489845|NCT02634151|144507458|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|0.2||||0.9665|TWO_SIDED|95.0|-8.3|8.6|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 8||8.6|-8.3|0.9665
72516352|NCT01512108|144563781|SUPERIORITY_OR_OTHER||Estimated treatment difference, Mean|-0.3||||0.0458||95.0|-0.6|-0.01|||ANOVA|||||-0.01|-0.60|0.0458
72489846|NCT02634151|144507458|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-6.2||||0.2358|TWO_SIDED|95.0|-16.4|4.1|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 12||4.1|-16.4|0.2358
72489847|NCT02634151|144507459|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-1.3||||0.0048|TWO_SIDED|95.0|-2.3|-0.4|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 4||-0.4|-2.3|0.0048
72489848|NCT02634151|144507459|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-0.1||||0.9064|TWO_SIDED|95.0|-0.9|0.8|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 8||0.8|-0.9|0.9064
72489849|NCT02634151|144507459|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-0.6||||0.2505|TWO_SIDED|95.0|-1.7|0.4|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 12||0.4|-1.7|0.2505
72489850|NCT02634151|144507460|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-15.8|||<|0.0001|TWO_SIDED|95.0|-22.6|-9.0|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 4||-9.0|-22.6|<0.0001
72489851|NCT02634151|144507460|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-7.2||||0.0406|TWO_SIDED|95.0|-14.0|-0.3|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 8||-0.3|-14.0|0.0406
72489852|NCT02634151|144507460|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-15.3|||<|0.0001|TWO_SIDED|95.0|-22.8|-7.8|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 12||-7.8|-22.8|<0.0001
72489853|NCT02634151|144507461|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-0.6|||<|0.0001|TWO_SIDED|95.0|-0.9|-0.3|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 4||-0.3|-0.9|<0.0001
72489854|NCT02634151|144507461|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-0.3||||0.0771|TWO_SIDED|95.0|-0.6|0.0|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 8||0.0|-0.6|0.0771
72516353|NCT02373371|144563783|SUPERIORITY|||||||0.846|||||||Wilcoxon (Mann-Whitney)|||"Main analysis:~* nbDPKAdispM3 the number of KA disappeared at M3 after treatment with DPDT compared to the inclusion layer,~* nbCPKAdispM3 the number of KA disappeared at M3 after treatment with conventional blue light,~The primary endpoint is:~differenceM3 = nbDPKAdispM3 - nbCPKAdispM3 The main analysis will consist of a signed Wilcoxon rank test for matched data testing whether difference M3 is significantly different from 0"||||0.8460
72516354|NCT02373371|144563785|SUPERIORITY|||||||0.0005|||||||Wilcoxon (Mann-Whitney)|||||||0.0005
72516355|NCT02373371|144563786|SUPERIORITY|||||||0.0001|||||||Wilcoxon (Mann-Whitney)|||||||0.0001
72516356|NCT00880763|144563864|SUPERIORITY_OR_OTHER||Adjusted difference in percent|65.1|||<|0.001|TWO_SIDED|95.0|37.0|82.8|||Miettinen and Nurminen||Computed using Miettinen and Nurminen method adjusting the strata (participation of Intensive-pharmacokinetic cohort vs. not).|||82.8|37.0|<0.001
72516357|NCT00880763|144563864|SUPERIORITY_OR_OTHER||Adjusted difference in percent|74.5|||<|0.001|TWO_SIDED|95.0|47.6|89.0|||Miettinen and Nurminen||Computed using Miettinen and Nurminen method adjusting the strata (participation of Intensive-pharmacokinetic cohort vs. not).|||89.0|47.6|<0.001
72489855|NCT02634151|144507461|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-0.6||||0.0006|TWO_SIDED|95.0|-1.0|-0.3|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 12||-0.3|-1.0|0.0006
72489856|NCT02634151|144507462|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|8.6||||0.121|TWO_SIDED|95.0|-2.3|19.6|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 4||19.6|-2.3|0.1210
72489857|NCT02634151|144507462|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|8.0||||0.0948|TWO_SIDED|95.0|-1.4|17.3|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 8||17.3|-1.4|0.0948
72489858|NCT02634151|144507462|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|4.1||||0.5113|TWO_SIDED|95.0|-8.2|16.4|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 12||16.4|-8.2|0.5113
72489859|NCT02634151|144507463|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|1.7||||0.7276|TWO_SIDED|95.0|-7.8|11.1|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 4||11.1|-7.8|0.7276
72489860|NCT02634151|144507463|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|4.7||||0.2218|TWO_SIDED|95.0|-2.9|12.2|||ANCOVA|||Week 8||12.2|-2.9|0.2218
72516358|NCT00880763|144563864|SUPERIORITY_OR_OTHER||Adjusted difference in percent|55.4|||<|0.001|TWO_SIDED|95.0|24.9|76.0|||Miettinen and Nurminen||Computed using Miettinen and Nurminen method adjusting the strata (participation of Intensive-pharmacokinetic cohort vs. not).|||76.0|24.9|<0.001
72516359|NCT00880763|144563865|SUPERIORITY_OR_OTHER||Adjusted difference in percent|4.8|||||TWO_SIDED|95.0|-11.3|24.2|||||Computed using Miettinen and Nurminen method adjusting the strata (participation of Intensive-pharmacokinetic cohort vs. not)|||24.2|-11.3|
72489861|NCT02634151|144507463|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|0.3||||0.942|TWO_SIDED|95.0|-9.2|9.8|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 12||9.8|-9.2|0.9420
72489862|NCT02634151|144507464|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|32.57||||0.6786|TWO_SIDED|95.0|-122.98|188.12|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||||188.12|-122.98|0.6786
72489863|NCT02634151|144507465|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-0.84||||0.1648|TWO_SIDED|95.0|-2.03|0.35|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||||0.35|-2.03|0.1648
72489864|NCT02634151|144507466|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|41.5||||0.4701|TWO_SIDED|95.0|-72.1|155.1|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||||155.1|-72.1|0.4701
72489865|NCT02634151|144507467|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-32.4||||0.0517|TWO_SIDED|95.0|-65.1|0.2|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||||0.2|-65.1|0.0517
72489866|NCT02634151|144507468|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-9.5||||0.9111|TWO_SIDED|95.0|-177.8|158.8|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||||158.8|-177.8|0.9111
72489867|NCT02634151|144507469|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-3.0||||0.3864|TWO_SIDED|95.0|-10.0|3.9|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||||3.9|-10.0|0.3864
72489868|NCT02634151|144507470|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|12.2||||0.0145|TWO_SIDED|95.0|2.5|22.0|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||||22.0|2.5|0.0145
72516360|NCT00880763|144563865|SUPERIORITY_OR_OTHER||Adjusted difference in percent|4.9|||||TWO_SIDED|95.0|-12.4|24.2|||||Computed using Miettinen and Nurminen method adjusting the strata (participation of Intensive-pharmacokinetic cohort vs. not)|||24.2|-12.4|
72516361|NCT00880763|144563865|SUPERIORITY_OR_OTHER||Adjusted difference in percent|4.8|||||TWO_SIDED|95.0|-12.0|24.2|||||Computed using Miettinen and Nurminen method adjusting the strata (participation of Intensive-pharmacokinetic cohort vs. not)|||24.2|-12.0|
72516362|NCT00880763|144563866|SUPERIORITY_OR_OTHER||Adjusted difference in percent|14.5|||||TWO_SIDED|95.0|-2.5|36.2|||||Computed using Miettinen and Nurminen method adjusting the strata (participation of Intensive-pharmacokinetic cohort vs. not)|||36.2|-2.5|
72516363|NCT00880763|144563866|SUPERIORITY_OR_OTHER||Adjusted difference in percent|14.6|||||TWO_SIDED|95.0|-3.4|36.3|||||Computed using Miettinen and Nurminen method adjusting the strata (participation of Intensive-pharmacokinetic cohort vs. not)|||36.3|-3.4|
72516364|NCT00880763|144563866|SUPERIORITY_OR_OTHER||Adjusted difference in percent|14.4|||||TWO_SIDED|95.0|-3.3|36.1|||||Computed using Miettinen and Nurminen method adjusting the strata (participation of Intensive-pharmacokinetic cohort vs. not)|||36.1|-3.3|
72516365|NCT00880763|144563867|SUPERIORITY_OR_OTHER||Difference in least squares mean|-1.8|||||TWO_SIDED|95.0|-2.3|-1.2|||||Computed using a longitudinal data analysis model including treatment, time and the interaction of time by treatment, with a restriction of the same baseline mean across treatment groups.|||-1.2|-2.3|
72516366|NCT00880763|144563867|SUPERIORITY_OR_OTHER||Difference in least squares mean|-1.9|||||TWO_SIDED|95.0|-2.4|-1.3|||||Computed using a longitudinal data analysis model including treatment, time and the interaction of time by treatment, with a restriction of the same baseline mean across treatment groups.|||-1.3|-2.4|
72489869|NCT02634151|144507471|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|0.8||||0.051|TWO_SIDED|95.0|0.0|1.5|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||||1.5|-0.0|0.0510
72489870|NCT02347098|144507473|SUPERIORITY|||||||0.2533|||||||t-test, 2 sided|||||||0.2533
72489871|NCT02347098|144507474|SUPERIORITY|||||||0.779|||||||t-test, 2 sided|||||||0.7790
72489872|NCT02347098|144507475|SUPERIORITY|||||||0.4549||||||The p-value reported compares the trends of outcome across time (baseline pre-PCI, baseline post-PCI, 30-day follow-up, and 90-day follow-up) between treatment groups using the repeated measurement analysis.|Mixed Models Analysis|||||||0.4549
72489873|NCT02347098|144507476|SUPERIORITY|||||||0.2663|||||||Fisher Exact|||||||0.2663
72489874|NCT02187172|144507477|SUPERIORITY||Mean Difference (Final Values)|-0.2456|STANDARD_ERROR_OF_MEAN|0.07||0.0012|TWO_SIDED|95.0|-0.3873|-0.104|||Regression, Linear|||Comparison during RCT period||-0.1040|-0.3873|0.0012
72489875|NCT02187172|144507477|SUPERIORITY||Mean Difference (Final Values)|-0.0151|STANDARD_ERROR_OF_MEAN|0.0353||0.6718|TWO_SIDED|95.0|-0.0867|0.0565|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment.||0.0565|-0.0867|0.6718
72489876|NCT02187172|144507478|SUPERIORITY||Mean Difference (Final Values)|-64.97|STANDARD_ERROR_OF_MEAN|44.88||0.1159|TWO_SIDED|95.0|-115.83|25.89|||Regression, Linear|||Comparison during RCT period||25.89|-115.83|0.1159
72516367|NCT00880763|144563867|SUPERIORITY_OR_OTHER||Difference in least squares mean|-1.6|||||TWO_SIDED|95.0|-2.2|-1.1|||||Computed using a longitudinal data analysis model including treatment, time and the interaction of time by treatment, with a restriction of the same baseline mean across treatment groups.|||-1.1|-2.2|
72516368|NCT01293006|144563894|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.39|||||TWO_SIDED|90.0|-0.12|0.91|||Difference of Least Squares Means|||Difference (Suvorexant - Placebo) of Least Squares Means||0.91|-0.12|
72516369|NCT01293006|144563897|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.03|||||TWO_SIDED|90.0|-1.3|3.36|||Difference of the Least Means Squares|||Day 1, SaO2 \<90%, Difference (Suvorexant - Placebo) of Least Squares Means||3.36|-1.30|
72489877|NCT02187172|144507478|SUPERIORITY||Mean Difference (Final Values)|6.65|STANDARD_ERROR_OF_MEAN|22.24||0.7666|TWO_SIDED|95.0|-38.41|51.72|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment.||51.72|-38.41|0.7666
72489878|NCT02187172|144507479|SUPERIORITY||Mean Difference (Final Values)|-80.89|STANDARD_ERROR_OF_MEAN|30.46||0.0115|TWO_SIDED|95.0|-142.55|-19.23|||Regression, Linear|||Comparison during RCT period||-19.23|-142.55|0.0115
72489879|NCT02187172|144507479|SUPERIORITY||Mean Difference (Final Values)|-1.99|STANDARD_ERROR_OF_MEAN|14.11||0.8883|TWO_SIDED|95.0|-30.58|26.59|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment.||26.59|-30.58|0.8883
72489880|NCT02187172|144507480|SUPERIORITY||Mean Difference (Final Values)|-3027.21|STANDARD_ERROR_OF_MEAN|3180.58||0.3472|TWO_SIDED|95.0|-9465.95|3411.54|||Regression, Linear|||Comparison during RCT period||3411.54|-9465.95|0.3472
72489881|NCT02187172|144507480|SUPERIORITY||Mean Difference (Final Values)|-1974.63|STANDARD_ERROR_OF_MEAN|1659.11||0.2416|TWO_SIDED|95.0|-5336.3|1387.04|||Regression, Linear|||Combined ustekinumab and placebo groups for active treatment period analysis.||1387.04|-5336.30|0.2416
72489882|NCT02187172|144507481|SUPERIORITY||Mean Difference (Final Values)|20.66|STANDARD_ERROR_OF_MEAN|24.75||0.6742|TWO_SIDED|95.0|-78.03|119.34|||Regression, Linear|||Comparison during RCT period||119.34|-78.03|0.6742
72489883|NCT02187172|144507481|SUPERIORITY||Mean Difference (Final Values)|47.0|STANDARD_ERROR_OF_MEAN|35.84||0.1979|TWO_SIDED|95.0|-25.63|11963.0|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment.||11963|-25.63|0.1979
72489884|NCT02187172|144507482|SUPERIORITY||Mean Difference (Final Values)|-7884.29|STANDARD_ERROR_OF_MEAN|7780.29||0.3173|TWO_SIDED|95.0|-23634.67|7566.1|||Regression, Linear|||Comparison during RCT period||7566.10|-23634.67|0.3173
72489885|NCT02187172|144507482|SUPERIORITY||Mean Difference (Final Values)|-3782.54|STANDARD_ERROR_OF_MEAN|4073.25||0.3591|TWO_SIDED|95.0|-12035.72|4470.64|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment.||4470.64|-12035.72|0.3591
72489886|NCT02187172|144507483|SUPERIORITY||Mean Difference (Final Values)|-0.07|STANDARD_ERROR_OF_MEAN|2.54||0.9767|TWO_SIDED|95.0|-5.22|5.07|||Regression, Linear|||Comparison during RCT period||5.07|-5.22|0.9767
72489887|NCT02187172|144507483|SUPERIORITY||Mean Difference (Final Values)|-1.09|STANDARD_ERROR_OF_MEAN|1.09||0.3205|TWO_SIDED|95.0|-3.29|1.11|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment.||1.11|-3.29|0.3205
72489888|NCT02187172|144507484|SUPERIORITY||Mean Difference (Final Values)|-14.79|STANDARD_ERROR_OF_MEAN|19.96||0.4632|TWO_SIDED|95.0|-55.19|25.61|||Regression, Linear|||Comparison during RCT period||25.61|-55.19|0.4632
72624385|NCT02507934|144778678|SUPERIORITY||Mean Difference (Final Values)|7.58||||0.0077|TWO_SIDED|95.0|1.7|13.45||For each parameter, for each eye, an ANOVA model for repeated measures has been used by including each available timepoint. The estimated mean difference between treatments (Vismed-Lubricin) over time has been reported and tested.|repeated measures ANOVA|||Analysis of variance for repeated measures on Foreign body sensation - Right eye||13.45|1.70|0.0077
72489889|NCT02187172|144507484|SUPERIORITY||Mean Difference (Final Values)|-7.24|STANDARD_ERROR_OF_MEAN|11.47||0.5316|TWO_SIDED|95.0|-30.47|15.99|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment.||15.99|-30.47|0.5316
72489890|NCT02187172|144507485|SUPERIORITY||Mean Difference (Final Values)|-0.9|STANDARD_ERROR_OF_MEAN|0.68||0.1928|TWO_SIDED|95.0|-2.27|0.47|||Regression, Linear|||Comparison during RCT period||0.47|-2.27|0.1928
72489891|NCT02187172|144507485|SUPERIORITY||Mean Difference (Final Values)|-0.67|STANDARD_ERROR_OF_MEAN|0.34||0.058|TWO_SIDED|95.0|-1.36|0.02|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment.||0.02|-1.36|0.0580
72489892|NCT02187172|144507486|SUPERIORITY||Mean Difference (Final Values)|-4.14|STANDARD_ERROR_OF_MEAN|11.41||0.7185|TWO_SIDED|95.0|-27.24|18.96|||Regression, Linear|||Comparison during RCT period||18.96|-27.24|0.7185
72489893|NCT02187172|144507486|SUPERIORITY||Mean Difference (Final Values)|-8.35|STANDARD_ERROR_OF_MEAN|8.41||0.3271|TWO_SIDED|95.0|-25.4|8.69|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment.||8.69|-25.40|0.3271
72489894|NCT02187172|144507487|SUPERIORITY||Mean Difference (Final Values)|-0.52|STANDARD_ERROR_OF_MEAN|0.51||0.3124|TWO_SIDED|95.0|-1.56|0.51|||Regression, Linear|||Comparison during RCT period||0.51|-1.56|0.3124
72489895|NCT02187172|144507487|SUPERIORITY||Mean Difference (Final Values)|-0.31|STANDARD_ERROR_OF_MEAN|0.11||0.0106|TWO_SIDED|95.0|-0.54|-0.08|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment.||-0.08|-0.54|0.0106
72489896|NCT02187172|144507488|SUPERIORITY||Mean Difference (Final Values)|-70.76|STANDARD_ERROR_OF_MEAN|33.42||0.0408|TWO_SIDED|95.0|-138.42|-3.11|||Regression, Linear|||Comparison during RCT period||-3.11|-138.42|0.0408
72489897|NCT02187172|144507488|SUPERIORITY||Mean Difference (Final Values)|71.72|STANDARD_ERROR_OF_MEAN|132.87||0.5926|TWO_SIDED|95.0|-197.5|340.93|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment.||340.93|-197.50|0.5926
72489898|NCT02187172|144507489|SUPERIORITY||Mean Difference (Final Values)|191.49|STANDARD_ERROR_OF_MEAN|46.1||0.0002|TWO_SIDED|95.0|98.18|284.81|||Regression, Linear|||Comparison during RCT period||284.81|98.18|0.0002
72489899|NCT02187172|144507489|SUPERIORITY||Mean Difference (Final Values)|171.21|STANDARD_ERROR_OF_MEAN|20.3|<|0.0001|TWO_SIDED|95.0|130.08|212.34|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment.||212.34|130.08|<0.0001
72489900|NCT02187172|144507490|SUPERIORITY||Mean Difference (Final Values)|-2.63|STANDARD_ERROR_OF_MEAN|0.98||0.011|TWO_SIDED|95.0|-4.62|-0.64|||Regression, Linear|||Comparison during RCT period||-0.64|-4.62|0.0110
72489901|NCT02187172|144507490|SUPERIORITY||Mean Difference (Final Values)|-1.15|STANDARD_ERROR_OF_MEAN|0.32||0.0008|TWO_SIDED|95.0|-1.79|-0.51|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment.||-0.51|-1.79|0.0008
72489902|NCT02187172|144507491|SUPERIORITY||Mean Difference (Final Values)|-155.31|STANDARD_ERROR_OF_MEAN|688.28||0.8227|TWO_SIDED|95.0|-1548.66|1238.04|||Regression, Linear|||Comparison during RCT period||1238.04|-1548.66|0.8227
72489903|NCT02187172|144507491|SUPERIORITY||Mean Difference (Final Values)|-407.43|STANDARD_ERROR_OF_MEAN|180.7||0.0302|TWO_SIDED|95.0|-773.57|-41.29|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment.||-41.29|-773.57|0.0302
72489904|NCT02187172|144507492|SUPERIORITY||Mean Difference (Final Values)|-0.47|STANDARD_ERROR_OF_MEAN|-0.47||0.2333|TWO_SIDED|95.0|-1.25|0.32|||Regression, Linear|||Comparison during RCT period||0.32|-1.25|0.2333
72404373|NCT00615056|144315530|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.273||||0.8268|TWO_SIDED|95.0|0.769|2.108||One-sided log-rank test at alpha = 0.15 significance level was used.|Log Rank|||Differences in PFS between treatment arms was analyzed by 1-sided log rank test, stratified for Eastern Cooperative Oncology Group (ECOG) performance status (0 versus 1) and prior treatment with bevacizumab (yes versus no).||2.108|0.769|0.8268
72404374|NCT00615056|144315530|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.041||||0.5498|TWO_SIDED|95.0|0.553|1.041||One-sided log-rank test at alpha = 0.15 significance level was used.|Log Rank|||Differences in PFS between treatment arms was analyzed by 1-sided log rank test, stratified for ECOG performance status (0 versus 1) and prior treatment with bevacizumab (yes versus no).||1.041|0.553|0.5498
72404375|NCT00615056|144315531|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.355||||0.8828|TWO_SIDED|95.0|0.82|2.238||One-sided log-rank test at alpha = 0.15 significance level was used.|Log Rank|||Differences in OS between treatment arms was analyzed by 1-sided log rank test, stratified for ECOG performance status (0 versus 1) and prior treatment with bevacizumab (yes versus no).||2.238|0.820|0.8828
72404376|NCT00615056|144315531|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.689||||0.1159|TWO_SIDED|95.0|0.373|1.273||One-sided log-rank test at alpha = 0.15 significance level was used.|Log Rank|||Differences in OS between treatment arms was analyzed by 1-sided log rank test, stratified for ECOG performance status (0 versus 1) and prior treatment with bevacizumab (yes versus no).||1.273|0.373|0.1159
72404377|NCT00615056|144315532|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.0||||0.4552|TWO_SIDED|95.0|-15.8|17.7|||Chi-squared|||One-sided Pearson chi square test at alpha = 0.15 significance level was used.||17.7|-15.8|0.4552
72404378|NCT00615056|144315532|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6||||0.5235|TWO_SIDED|95.0|-19.1|18.0|||Chi-squared|||One-sided Pearson chi square test at alpha = 0.15 significance level was used.||18.0|-19.1|0.5235
72404379|NCT01888497|144315803|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehman estimate|13.82|||<|0.001|TWO_SIDED|95.0|10.85|17.4||Statistical comparison was performed at a two-sided significance level of 0.05.|Wilcoxon Rank Sum test||Hodges-Lehman estimate of treatment difference was reported.|For primary endpoint sequential order of testing: triazolam versus (vs) placebo; gabapentin vs placebo; diphenhydramine citrate vs gabapentin; diphenhydramine citrate vs placebo. If comparison at preceding step was significant, only then subsequent comparisons were considered significant.||17.40|10.85|<0.001
72404380|NCT01888497|144315803|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|For gabapentin versus placebo comparison, the non-inferiority margin for upper limit of 95 percent (%) confidence interval (CI) was 2.4 cm.|Hodges-Lehman estimate|0.55|||||TWO_SIDED|95.0|-0.66|2.33|||||Hodges-Lehman estimate of treatment difference was reported.|For primary endpoint sequential order of testing: triazolam vs placebo; gabapentin vs placebo; diphenhydramine citrate vs gabapentin; diphenhydramine citrate vs placebo. If comparison at preceding step was significant, only then subsequent comparisons were considered significant.||2.33|-0.66|
72404381|NCT01888497|144315803|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehman estimate|1.02||||0.134|TWO_SIDED|95.0|-0.39|2.51||Statistical comparison was performed at a two-sided significance level of 0.05.|Wilcoxon Rank Sum test||Hodges-Lehman estimate of treatment difference was reported.|For primary endpoint sequential order of testing: triazolam vs placebo; gabapentin vs placebo; diphenhydramine citrate vs gabapentin; diphenhydramine citrate vs placebo. If comparison at preceding step was significant, only then subsequent comparisons were considered significant.||2.51|-0.39|0.134
72404382|NCT01888497|144315803|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehman estimate|2.37|||<|0.001|TWO_SIDED|95.0|1.01|3.98||Statistical comparison was performed at a two-sided significance level of 0.05.|Wilcoxon Rank Sum test||Hodges-Lehman estimate of treatment difference was reported.|For primary endpoint sequential order of testing: triazolam vs placebo; gabapentin vs placebo; diphenhydramine citrate vs gabapentin; diphenhydramine citrate vs placebo. If comparison at preceding step was significant, only then subsequent comparisons were considered significant.||3.98|1.01|<0.001
72404383|NCT01888497|144315804|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehman estimate|0.36|||<|0.001|TWO_SIDED|95.0|0.26|0.47||Statistical comparison was performed at a two-sided significance level of 0.05.|Wilcoxon Rank Sum test||Hodges-Lehman estimate of treatment difference was reported.|For secondary endpoint sequential order of testing: triazolam vs placebo; gabapentin vs placebo; diphenhydramine citrate vs gabapentin; diphenhydramine citrate vs placebo. If comparison at preceding step was significant, only then subsequent comparisons were considered significant.||0.47|0.26|<0.001
72489905|NCT02187172|144507492|SUPERIORITY||Mean Difference (Final Values)|-0.38|STANDARD_ERROR_OF_MEAN|0.21||0.0713|TWO_SIDED|95.0|-0.8|0.03|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment.||0.03|-0.80|0.0713
72489906|NCT02187172|144507493|SUPERIORITY||Mean Difference (Final Values)|-16.87|STANDARD_ERROR_OF_MEAN|15.62||0.2869|TWO_SIDED|95.0|-48.48|14.75|||Regression, Linear|||Comparison during RCT period||14.75|-48.48|0.2869
72489907|NCT02187172|144507493|SUPERIORITY||Mean Difference (Final Values)|-2.23|STANDARD_ERROR_OF_MEAN|1.71||0.1988|TWO_SIDED|95.0|-5.69|1.22|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment.||1.22|-5.69|0.1988
72489908|NCT02187172|144507494|SUPERIORITY||Mean Difference (Final Values)|2.06|STANDARD_ERROR_OF_MEAN|12.91||0.8744|TWO_SIDED|95.0|-24.09|28.2|||Regression, Linear|||Comparison during RCT period||28.20|-24.09|0.8744
72489909|NCT02187172|144507494|SUPERIORITY||Mean Difference (Final Values)|10.55|STANDARD_ERROR_OF_MEAN|8.26||0.2093|TWO_SIDED|95.0|-6.18|27.29|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment.||27.29|-6.18|0.2093
72489910|NCT02187172|144507495|SUPERIORITY||Mean Difference (Final Values)|19.2|STANDARD_ERROR_OF_MEAN|7.41||0.0135|TWO_SIDED|95.0|4.21|34.2|||Regression, Linear|||Comparison during RCT period||34.20|4.21|0.0135
72489911|NCT02187172|144507495|SUPERIORITY||Mean Difference (Final Values)|-0.79|STANDARD_ERROR_OF_MEAN|4.14||0.8499|TWO_SIDED|95.0|-9.19|7.61|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment.||7.61|-9.19|0.8499
72489912|NCT02187172|144507496|SUPERIORITY||Mean Difference (Final Values)|3.66|STANDARD_ERROR_OF_MEAN|1.96||0.0693|TWO_SIDED|95.0|-0.3|7.62|||Regression, Linear|||Comparison during RCT period||7.62|-0.30|0.0693
72489913|NCT02187172|144507496|SUPERIORITY||Mean Difference (Final Values)|1.92|STANDARD_ERROR_OF_MEAN|1.42||0.1841|TWO_SIDED|95.0|-0.96|4.8|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment.||4.80|-0.96|0.1841
72489914|NCT02187172|144507497|SUPERIORITY||Mean Difference (Final Values)|1.25|STANDARD_ERROR_OF_MEAN|1.03||0.2305|TWO_SIDED|95.0|-0.83|3.34|||Regression, Linear|||Comparison during RCT period||3.34|-0.83|0.2305
72489915|NCT02187172|144507497|SUPERIORITY||Mean Difference (Final Values)|0.91|STANDARD_ERROR_OF_MEAN|0.72||0.2189|TWO_SIDED|95.0|-0.53|2.37|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment.||2.37|-0.53|0.2189
72489916|NCT02187172|144507498|SUPERIORITY||Mean Difference (Final Values)|-0.11|STANDARD_ERROR_OF_MEAN|0.11||0.3212|TWO_SIDED|95.0|-0.34|0.11|||Regression, Linear|||Comparison during RCT period||0.11|-0.34|0.3212
72489917|NCT02187172|144507498|SUPERIORITY||Mean Difference (Final Values)|0.17|STANDARD_ERROR_OF_MEAN|0.07||0.0137|TWO_SIDED|95.0|0.04|0.31|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment.||0.31|0.04|0.0137
72489918|NCT02187172|144507499|SUPERIORITY||Mean Difference (Net)|0.12|STANDARD_ERROR_OF_MEAN|0.6||0.8383|TWO_SIDED|95.0|-1.09|1.33|||Regression, Linear|||Comparison during RCT period||1.33|-1.09|0.8383
72489919|NCT02187172|144507499|SUPERIORITY||Mean Difference (Final Values)|0.51|STANDARD_ERROR_OF_MEAN|0.36||0.1651|TWO_SIDED|95.0|-0.22|1.24|||Regression, Logistic|||Global change from baseline after 52 weeks of active treatment.||1.24|-0.22|0.1651
72489920|NCT02187172|144507500|SUPERIORITY||Mean Difference (Final Values)|2.49|STANDARD_ERROR_OF_MEAN|1.7||0.1502|TWO_SIDED|95.0|-0.94|5.93|||Regression, Linear|||Comparison during RCT period||5.93|-0.94|0.1502
72489921|NCT02187172|144507500|SUPERIORITY||Mean Difference (Final Values)|0.21|STANDARD_ERROR_OF_MEAN|0.84||0.8054|TWO_SIDED|95.0|-1.49|1.91|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment.||1.91|-1.49|0.8054
72489922|NCT02187172|144507501|SUPERIORITY||Mean Difference (Final Values)|-1.37|STANDARD_ERROR_OF_MEAN|1.69||0.4235|TWO_SIDED|95.0|-4.79|2.05|||Regression, Linear|||Comparison during RCT period||2.05|-4.79|0.4235
72489923|NCT02187172|144507501|SUPERIORITY||Mean Difference (Final Values)|0.17|STANDARD_ERROR_OF_MEAN|0.97||0.8653|TWO_SIDED|95.0|-1.8|2.13|||Regression, Linear|||Comparison during RCT period||2.13|-1.80|0.8653
72489924|NCT02187172|144507502|SUPERIORITY||Mean Difference (Final Values)|-1.12|STANDARD_ERROR_OF_MEAN|1.89||0.558|TWO_SIDED|95.0|-4.95|2.71|||Regression, Linear|||Comparison during RCT period||2.71|-4.95|0.5580
72489925|NCT02187172|144507502|SUPERIORITY||Mean Difference (Final Values)|0.77|STANDARD_ERROR_OF_MEAN|1.0||0.4454|TWO_SIDED|95.0|-1.25|2.8|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment.||2.80|-1.25|0.4454
72489926|NCT02187172|144507503|SUPERIORITY||Mean Difference (Final Values)|21.37|STANDARD_ERROR_OF_MEAN|6.67||0.0027|TWO_SIDED|95.0|7.86|34.87|||Regression, Linear|||Comparison during RCT period||34.87|7.86|0.0027
72489927|NCT02187172|144507503|SUPERIORITY||Mean Difference (Final Values)|-2.92|STANDARD_ERROR_OF_MEAN|4.07||0.4775|TWO_SIDED|95.0|-11.17|5.33|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment.||5.33|-11.17|0.4775
72489928|NCT02187172|144507504|SUPERIORITY||Mean Difference (Final Values)|230.77|STANDARD_ERROR_OF_MEAN|69.8||0.0021|TWO_SIDED|95.0|89.47|372.08|||Regression, Linear|||Comparison during RCT period||372.08|89.47|0.0021
72489929|NCT02187172|144507504|SUPERIORITY||Mean Difference (Final Values)|-31.89|STANDARD_ERROR_OF_MEAN|41.71||0.4493|TWO_SIDED|95.0|-116.4|52.61|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment.||52.61|-116.40|0.4493
72489930|NCT02187172|144507505|SUPERIORITY||Mean Difference (Final Values)|0.04|STANDARD_ERROR_OF_MEAN|0.17||0.8008|TWO_SIDED|95.0|-0.3|0.38|||Regression, Linear|||Comparison during RCT period||0.38|-0.30|0.8008
72489931|NCT02187172|144507505|SUPERIORITY||Mean Difference (Final Values)|0.03|STANDARD_ERROR_OF_MEAN|0.11||0.8068|TWO_SIDED|95.0|-0.19|0.24|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment.||0.24|-0.19|0.8068
72489932|NCT02187172|144507506|SUPERIORITY||Mean Difference (Final Values)|46.96|STANDARD_ERROR_OF_MEAN|56.12||0.4079|TWO_SIDED|95.0|-66.65|160.57|||Regression, Logistic|||Comparison during RCT period||160.57|-66.65|0.4079
72489933|NCT02187172|144507506|SUPERIORITY||Mean Difference (Final Values)|4.68|STANDARD_ERROR_OF_MEAN|33.85||0.8907|TWO_SIDED|95.0|-63.91|73.28|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment.||73.28|-63.91|0.8907
72489934|NCT02187172|144507507|SUPERIORITY||Mean Difference (Final Values)|7.01|STANDARD_ERROR_OF_MEAN|48.81||0.8866|TWO_SIDED|95.0|-91.8|105.81|||Regression, Linear|||Comparison during RCT period||105.81|-91.80|0.8866
72489935|NCT02187172|144507507|SUPERIORITY||Mean Difference (Final Values)|-24.74|STANDARD_ERROR_OF_MEAN|32.59||0.4527|TWO_SIDED|95.0|-90.78|41.3|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment.||41.30|-90.78|0.4527
72489936|NCT02187172|144507508|SUPERIORITY||Mean Difference (Final Values)|194.69|STANDARD_ERROR_OF_MEAN|66.23||0.0056|TWO_SIDED|95.0|60.61|328.77|||Regression, Linear|||Comparison during RCT period||328.77|60.61|0.0056
72489937|NCT02187172|144507508|SUPERIORITY||Mean Difference (Final Values)|-29.16|STANDARD_ERROR_OF_MEAN|38.01||0.4478|TWO_SIDED|95.0|-106.17|47.85|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment.||47.85|-106.17|0.4478
72489938|NCT02187172|144507509|SUPERIORITY||Mean Difference (Final Values)|3.14|STANDARD_ERROR_OF_MEAN|2.81||0.2704|TWO_SIDED|95.0|-2.55|8.83|||Regression, Linear|||Comparison during RCT period||8.83|-2.55|0.2704
72489939|NCT02187172|144507509|SUPERIORITY||Mean Difference (Final Values)|1.5|STANDARD_ERROR_OF_MEAN|1.41||0.295|TWO_SIDED|95.0|-1.36|4.36|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment||4.36|-1.36|0.2950
72489940|NCT02187172|144507510|SUPERIORITY||Mean Difference (Final Values)|-16.74|STANDARD_ERROR_OF_MEAN|6.57||0.0149|TWO_SIDED|95.0|-30.03|-3.45|||Regression, Linear|||Comparison during RCT period||-3.45|-30.03|0.0149
72404384|NCT01888497|144315804|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|For gabapentin versus placebo comparison, the non-inferiority margin for upper limit of 95% CI was 0.1 m/sec.|Hodges-Lehman estimate|-0.01|||||TWO_SIDED|95.0|-0.07|0.05|||||Hodges-Lehman estimate of treatment difference was reported.|For secondary endpoint sequential order of testing: triazolam vs placebo; gabapentin vs placebo; diphenhydramine citrate vs gabapentin; diphenhydramine citrate vs placebo. If comparison at preceding step was significant, only then subsequent comparisons were considered significant.||0.05|-0.07|
72404385|NCT01888497|144315804|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehman estimate|0.07||||0.012|TWO_SIDED|95.0|0.02|0.12||Statistical comparison was performed at a two-sided significance level of 0.05.|Wilcoxon Rank Sum test||Hodges-Lehman estimate of treatment difference was reported.|For secondary endpoint sequential order of testing: triazolam vs placebo; gabapentin vs placebo; diphenhydramine citrate vs gabapentin; diphenhydramine citrate vs placebo. If comparison at preceding step was significant, only then subsequent comparisons were considered significant.||0.12|0.02|0.012
72404386|NCT01888497|144315804|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehman estimate|0.06||||0.014|TWO_SIDED|95.0|0.01|0.12||Statistical comparison was performed at a two-sided significance level of 0.05.|Wilcoxon Rank Sum test||Hodges-Lehman estimate of treatment difference was reported.|For secondary endpoint sequential order of testing: triazolam vs placebo; gabapentin vs placebo; diphenhydramine citrate vs gabapentin; diphenhydramine citrate vs placebo. If comparison at preceding step was significant, only then subsequent comparisons were considered significant.||0.12|0.01|0.014
72404387|NCT01888497|144315805|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehman estimate|103.25|||<|0.001|TWO_SIDED|95.0|72.0|130.5||Statistical comparison was performed at a two-sided significance level of 0.05.|Wilcoxon Rank Sum test||Hodges-Lehman estimate of treatment difference was reported.|For secondary endpoint sequential order of testing: triazolam vs placebo; gabapentin vs placebo; diphenhydramine citrate vs gabapentin; diphenhydramine citrate vs placebo. If comparison at preceding step was significant, only then subsequent comparisons were considered significant.||130.50|72.00|<0.001
72404388|NCT01888497|144315805|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|For gabapentin versus placebo comparison, the non-inferiority margin for upper limit of 95% CI was 8 lanes.|Hodges-Lehman estimate|5.0|||||TWO_SIDED|95.0|-4.0|16.5|||||Hodges-Lehman estimate of treatment difference was reported.|For secondary endpoint sequential order of testing: triazolam vs placebo; gabapentin vs placebo; diphenhydramine citrate vs gabapentin; diphenhydramine citrate vs placebo. If comparison at preceding step was significant, only then subsequent comparisons were considered significant.||16.50|-4.00|
72404389|NCT01888497|144315805|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehman estimate|3.0||||0.213|TWO_SIDED|95.0|-3.0|9.0||Statistical comparison was performed at a two-sided significance level of 0.05.|Wilcoxon Rank Sum test||Hodges-Lehman estimate of treatment difference was reported.|For secondary endpoint sequential order of testing: triazolam vs placebo; gabapentin vs placebo; diphenhydramine citrate vs gabapentin; diphenhydramine citrate vs placebo. If comparison at preceding step was significant, only then subsequent comparisons were considered significant.||9.00|-3.00|0.213
72404390|NCT01888497|144315805|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehman estimate|11.0||||0.003|TWO_SIDED|95.0|4.0|20.5||Statistical comparison was performed at a two-sided significance level of 0.05.|Wilcoxon Rank Sum test||Hodges-Lehman estimate of treatment difference was reported.|For secondary endpoint sequential order of testing: triazolam vs placebo; gabapentin vs placebo; diphenhydramine citrate vs gabapentin; diphenhydramine citrate vs placebo. If comparison at preceding step was significant, only then subsequent comparisons were considered significant.||20.50|4.00|0.003
72404391|NCT04013191|144315809|OTHER||Point Estimate|0.928|||||TWO_SIDED|90.0|0.725|1.19|||ANOVA|||The analysis of variance (ANOVA) model included the fixed effects of age group. The natural logs were taken of the dependent variables and back-transformed after the analysis.||1.19|0.725|
72489941|NCT02187172|144507510|SUPERIORITY||Mean Difference (Final Values)|-0.11|STANDARD_ERROR_OF_MEAN|3.37||0.9734|TWO_SIDED|95.0|-6.93|6.71|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment||6.71|-6.93|0.9734
72489942|NCT02187172|144507511|SUPERIORITY||Mean Difference (Net)|-9.21|STANDARD_ERROR_OF_MEAN|11.76||0.4384|TWO_SIDED|95.0|-33.03|14.6|||Regression, Linear|||Comparison during RCT period||14.60|-33.03|0.4384
72489943|NCT02187172|144507511|SUPERIORITY||Mean Difference (Final Values)|11.14|STANDARD_ERROR_OF_MEAN|7.33||0.1373|TWO_SIDED|95.0|-3.72|25.99|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment||25.99|-3.72|0.1373
72516370|NCT01293006|144563897|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.21|||||TWO_SIDED|90.0|-0.08|0.5|||Difference of the Least Squares Means|||Day 1, SaO2 \<85%, Difference (Suvorexant - Placebo) of Least Squares Means||0.50|-0.08|
72404392|NCT04013191|144315810|OTHER||Point Estimate|1.22|||||TWO_SIDED|90.0|0.894|1.67|||ANOVA|||The ANOVA model included the fixed effects of age group. The natural logs were taken of the dependent variables and back-transformed after the analysis.||1.67|0.894|
72489944|NCT02187172|144507512|SUPERIORITY||Mean Difference (Final Values)|-15.71|STANDARD_ERROR_OF_MEAN|5.77||0.0097|TWO_SIDED|95.0|-27.39|-4.03|||Regression, Linear|||Comparison during RCT period||-4.03|-27.39|0.0097
72489945|NCT02187172|144507512|SUPERIORITY||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|2.07||0.8119|TWO_SIDED|95.0|-4.69|3.7|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment||3.70|-4.69|0.8119
72489946|NCT02187172|144507513|SUPERIORITY||Mean Difference (Final Values)|0.34|STANDARD_ERROR_OF_MEAN|4.57||0.9415|TWO_SIDED|95.0|-8.91|9.59|||Regression, Linear|||Comparison during RCT period||9.59|-8.91|0.9415
72516371|NCT01293006|144563897|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.82|||||TWO_SIDED|90.0|-5.77|7.41|||Difference of the Least Squares Means|||Day 4, SaO2 \<90%, Difference (Suvorexant - Placebo) of Least Squares Means||7.41|-5.77|
72404393|NCT04013191|144315811|OTHER||Point Estimate|1.22|||||TWO_SIDED|90.0|0.893|1.68|||ANOVA|||The ANOVA model included the fixed effects of age group. The natural logs were taken of the dependent variables and back-transformed after the analysis.||1.68|0.893|
72404394|NCT04013191|144315812|OTHER||Point Estimate|1.02|||||TWO_SIDED|90.0|0.829|1.26|||ANOVA|||The ANOVA model included the fixed effects of age group. The natural logs were taken of the dependent variables and back-transformed after the analysis.||1.26|0.829|
72404395|NCT04013191|144315813|OTHER||Point Estimate|1.18|||||TWO_SIDED|90.0|0.908|1.53|||ANOVA|||The ANOVA model included the fixed effects of age group. The natural logs were taken of the dependent variables and back-transformed after the analysis.||1.53|0.908|
72404396|NCT02431754|144315825|SUPERIORITY_OR_OTHER|||||||0.0937|||||||Normal approximation (Z-test)|||||||0.0937
72404397|NCT02431754|144315826|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7||||0.1485|TWO_SIDED|95.0|-1.69|0.26|||Mixed Models Analysis|||||0.26|-1.69|0.1485
72489947|NCT02187172|144507513|SUPERIORITY||Mean Difference (Final Values)|-1.86|STANDARD_ERROR_OF_MEAN|2.43||0.4485|TWO_SIDED|95.0|-6.77|3.06|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment||3.06|-6.77|0.4485
72404398|NCT02904057|144315832|SUPERIORITY||Difference between proportion|92.1|||<|0.0001|TWO_SIDED|95.0|73.4|98.8|||Fisher Exact|||Imputed Data: Difference between proportion of treatment responders and control responders (P\[treatment\] - P\[control\] with confidence interval (CI) was calculated using an exact approach.||98.8|73.4|<0.0001
72404399|NCT02904057|144315832|SUPERIORITY||Difference between proportion|92.1|||<|0.0001|TWO_SIDED|95.0|73.4|98.8|||Fisher Exact|||Observed Data: Difference between proportion of treatment responders and control responders (P\[treatment\] - P\[control\] with CI was calculated using an exact approach.||98.8|73.4|<0.0001
72404400|NCT01275066|144315834|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|22.5|STANDARD_ERROR_OF_MEAN|9.35||0.0174||95.0||||Hochberg multiplicity adjustment - results considered statistically significant if both of p-values are p\<0.05 or either of p-values is p\<0.025.|ANCOVA|ANCOVA of change from baseline with treatment, age group, baseline 6MWT category as covariates.||||||0.0174
72404401|NCT01275066|144315834|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.5|STANDARD_ERROR_OF_MEAN|9.29||0.9542||||||Hochberg multiplicity adjustment - results considered statistically significant if both of p-values are p\<0.05 or either of p-values is p\<0.025.|ANCOVA|ANCOVA of change from baseline with treatment, age group, baseline 6MWT category as covariates.||||||0.9542
72404402|NCT01275066|144315835|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.1|STANDARD_ERROR_OF_MEAN|1.66||0.4935||||||Hochberg multiplicity adjustment - results considered statistically significant if both of p-values are p\<0.05 or either of p-values is p\<0.025.|ANCOVA|ANCOVA of change from baseline with treatment, age group, baseline 6MWT category, and baseline 3MSCT as covariates.||||||0.4935
72404403|NCT01275066|144315835|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|1.66||0.7783||||||Hochberg multiplicity adjustment - results considered statistically significant if both of p-values are p\<0.05 or either of p-values is p\<0.025.|ANCOVA|ANCOVA of change from baseline with treatment, age group, baseline 6MWT category, and baseline 3MSCT as covariates.||||||0.7783
72404404|NCT01275066|144315836|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-40.7|STANDARD_ERROR_OF_MEAN|4.2|<|0.0001||||||Hochberg multiplicity adjustment - results considered statistically significant if both of p-values are p\<0.05 or either of p-values is p\<0.025.|ANCOVA|ANCOVA of change from baseline with treatment, age group, baseline 6MWT category, and baseline uKS normalized for creatinine, as covariates.||||||<0.0001
72404405|NCT01275066|144315836|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-30.2|STANDARD_ERROR_OF_MEAN|4.19|<|0.0001||||||Hochberg multiplicity adjustment - results considered statistically significant if both of p-values are p\<0.05 or either of p-values is p\<0.025.|ANCOVA|ANCOVA of change from baseline with treatment, age group, baseline 6MWT category, and baseline uKS normalized for creatinine, as covariates.||||||<0.0001
72489948|NCT02187172|144507514|SUPERIORITY||Mean Difference (Final Values)|0.08|STANDARD_ERROR_OF_MEAN|5.16||0.988|TWO_SIDED|95.0|-10.37|10.53|||Regression, Linear|||Comparison during RCT period||10.53|-10.37|0.9880
72489949|NCT02187172|144507514|SUPERIORITY||Mean Difference (Final Values)|0.38|STANDARD_ERROR_OF_MEAN|2.59||0.8836|TWO_SIDED|95.0|-4.86|5.63|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment||5.63|-4.86|0.8836
72489950|NCT02187172|144507515|SUPERIORITY||Mean Difference (Final Values)|-0.28|STANDARD_ERROR_OF_MEAN|1.3||0.8321|TWO_SIDED|95.0|-2.91|2.36|||Regression, Linear|||Comparison during RCT period||2.36|-2.91|0.8321
72489951|NCT02187172|144507515|SUPERIORITY||Mean Difference (Final Values)|2.3|STANDARD_ERROR_OF_MEAN|1.08||0.0394|TWO_SIDED|95.0|0.12|4.48|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment||4.48|0.12|0.0394
72489952|NCT02187172|144507516|SUPERIORITY||Mean Difference (Final Values)|152.68|STANDARD_ERROR_OF_MEAN|43.76||0.0012|TWO_SIDED|95.0|64.07|241.23|||Regression, Linear|||Comparison during RCT period||241.23|64.07|0.0012
72489953|NCT02187172|144507516|SUPERIORITY||Mean Difference (Final Values)|-2.97|STANDARD_ERROR_OF_MEAN|25.7||0.9085|TWO_SIDED|95.0|-55.04|49.09|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment||49.09|-55.04|0.9085
72489954|NCT02187172|144507517|SUPERIORITY||Mean Difference (Final Values)|0.06|STANDARD_ERROR_OF_MEAN|0.04||0.1792|TWO_SIDED|95.0|-0.03|0.14|||Regression, Linear|||Comparison during RCT period||0.14|-0.03|0.1792
72489955|NCT02187172|144507517|SUPERIORITY||Mean Difference (Final Values)|0.04|STANDARD_ERROR_OF_MEAN|0.03||0.2559|TWO_SIDED|95.0|-0.03|0.1|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment||0.10|-0.03|0.2559
72489956|NCT02187172|144507518|SUPERIORITY||Mean Difference (Final Values)|0.15|STANDARD_ERROR_OF_MEAN|0.13||0.2453|TWO_SIDED|95.0|-0.11|0.41|||Regression, Linear|||||0.41|-0.11|0.2453
72489957|NCT02187172|144507518|SUPERIORITY||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.06||0.1087|TWO_SIDED|95.0|-0.02|0.23|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment||0.23|-0.02|0.1087
72404406|NCT00934544|144315854|SUPERIORITY_OR_OTHER||Kaplan-Meir estimate|28.1|STANDARD_DEVIATION|22.123|<|0.0001|TWO_SIDED|95.0|21.3|36.6|||Cochran-Mantel-Haenszel|||||36.6|21.3|<0.0001
72404407|NCT01218516|144315865|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.23||||0.3519|TWO_SIDED|80.0|0.92|1.63||Per Primary Analysis Cut-Off Date|Log Rank|||||1.63|0.92|0.3519
72404408|NCT01218516|144315865|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.34||||0.1555|TWO_SIDED|80.0|1.03|1.74||Per Final Analysis Cut-Off Date|Log Rank|||||1.74|1.03|0.1555
72516372|NCT01293006|144563897|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.32|||||TWO_SIDED|90.0|0.0|0.63|||Difference of the Least Squares Means|||Day 4, SaO2 \<85%, Difference (Suvorexant - Placebo) of Least Squares Means||0.63|0.00|
72516373|NCT01293006|144563898|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.72|||||TWO_SIDED|90.0|-0.6|2.04|||Difference of the Least Squares Means|||Day 1, Difference (Suvorexant - Placebo) of Least Squares Means||2.04|-0.60|
72516374|NCT01293006|144563898|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.05|||||TWO_SIDED|90.0|0.33|3.77|||Difference of the Least Squares Means|||Day 4, Difference (Suvorexant - Placebo) of Least Squares Means||3.77|0.33|
72516375|NCT01293006|144563899|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.03|||||TWO_SIDED|90.0|-0.41|0.47|||Difference in the Least Squares Means|||Day 1, REM, Difference (Suvorexant - Placebo) of Least Squares Means||0.47|-0.41|
72516376|NCT01293006|144563899|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.13|||||TWO_SIDED|90.0|-0.53|0.27|||Difference of the Least Squares Means|||Day 1, Non-REM, Difference (Suvorexant - Placebo) of Least Squares Means||0.27|-0.53|
72516377|NCT01293006|144563899|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.21|||||TWO_SIDED|90.0|-0.61|0.18|||Difference of the Least Squares Means|||Day 1, Wake, Difference (Suvorexant - Placebo) of Least Squares Means||0.18|-0.61|
72516378|NCT01293006|144563899|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.33|||||TWO_SIDED|90.0|-0.32|0.98|||Difference of the Least Squares Means|||Day 4, REM, Difference (Suvorexant - Placebo) of Least Squares Means||0.98|-0.32|
72516379|NCT01293006|144563899|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.26|||||TWO_SIDED|90.0|-0.26|0.78|||Difference of the Least Squares Means|||Day 4, Non-REM, Difference (Suvorexant - Placebo) of Least Squares Means||0.78|-0.26|
72516380|NCT01293006|144563899|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.45|||||TWO_SIDED|90.0|0.1|0.8|||Difference of the Least Squares Means|||Day 4, Wake, Difference (Suvorexant - Placebo) of Least Squares Means||0.80|0.10|
72516381|NCT01293006|144563900|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|||||TWO_SIDED|90.0|-0.5|0.31|||Difference in the Least Squares Means|||Difference (Suvorexant - Placebo) of Least Squares Means||0.31|-0.50|
72516382|NCT02215616|144563920|OTHER||Least square (LS) mean difference|0.78||||0.4853|TWO_SIDED|95.0|-1.42|2.98||Threshold for significance at 0.045 level.|Mixed Models Analysis|||Analysis was performed using Mixed Model Repeated Measures model (MMRM) with treatment group (3 levels: placebo, laquinimod 0.5 mg and laquinimod 1 mg), categorical week (4 levels: Weeks 4, 13, 26, and 52), treatment by week interaction, country, TMS baseline value and TMS baseline by week interaction as fixed effects. Unstructured variance-covariance structure was used in the initial model.||2.98|-1.42|0.4853
72516383|NCT04015440|144563929|OTHER|Linear Regression|||||<|0.001|||||||Regression, Linear|||||||<.001
72516384|NCT04015440|144563930|OTHER|Regression||||||0.027|||||||Regression, Linear|||||||.027
72516385|NCT04015440|144563931|OTHER|Logistic Regression||||||0.004|||||||Regression, Logistic|||||||.004
72516386|NCT01315002|144563940|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||ANOVA|||Null hypothesis is that there was no difference in change of error percentage in the antisaccade task between nicotine and placebo. An ANOVA model was used with treatment (nicotine, placebo) as a within-subjects factor. The test was performed with a significance level of 0.05 (two-sided). Results showed significantly better antisaccade performance (i.e. less antisaccade errors) in the nicotine condition.||||<0.05
72516387|NCT05053126|144563941|SUPERIORITY||Mean Difference (Final Values)|36.83|STANDARD_ERROR_OF_MEAN|3.132|<|0.0001|ONE_SIDED|95.0|31.65||||Mixed Models Analysis|||"The sensitivity and integrity of the study was validated by comparing the mean responses of oxycodone HCl, the positive control (C), to the placebo (P):~H0: μC - μP ≤ δ1 versus Ha: μC - μP \> δ1 where δ1 =15"|||31.65|<0.0001
72516388|NCT05053126|144563941|NON_INFERIORITY|Non-inferiority margin = 0|Mean Difference (Final Values)|-2.4|STANDARD_ERROR_OF_MEAN|3.49||0.2469|ONE_SIDED|95.0||3.4|||Mixed Models Analysis|||"The primary analysis evaluated whether pregabalin plus oxycodone HCl (T) produced mean responses that showed abuse potential that was no higher than oxycodone HCl (C). The margin for showing no significant difference was defined as 20% of the difference between oxycodone HCl (C) and Placebo (P):~H0: μT - μC ≥ 0.2(μC - μP) versus Ha: μT - μC \<0.2(μC - μP)."||3.4||0.2469
72516389|NCT05053126|144563941|NON_INFERIORITY|Non-inferiority margin = 0|Mean Difference (Final Values)|-3.3|STANDARD_ERROR_OF_MEAN|3.48||0.1756|ONE_SIDED|95.0||2.5|||Mixed Models Analysis|||"The primary analysis evaluated whether pregabalin plus oxycodone HCl (T) produced mean responses that showed abuse potential that was no higher than oxycodone HCl (C). The margin for showing no significant difference was defined as 20% of the difference between oxycodone HCl (C) and Placebo (P):~H0: μT - μC ≥ 0.2(μC - μP) versus Ha: μT - μC \<0.2(μC - μP)."||2.5||0.1756
72516390|NCT05053126|144563941|NON_INFERIORITY|Non-inferiority margin = 10|Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|2.84||0.0001|ONE_SIDED|95.0||4.3|||Mixed Models Analysis|||"The null and alternative hypotheses for evaluating whether pregabalin (L) produced mean responses that show less abuse potential than oxycodone HCl (C) were:~H0: μC - μL ≤ 0.2 (μC - 50) versus Ha: μC - μL \> 0.2 (μC - 50)"||4.3||0.0001
72404409|NCT01714310|144315896|SUPERIORITY|||||||0.58||||||Group: F=.31, df=1/140|Mixed Models Analysis|Partial linear regression using mixed model, assessing outcome variable over time (baseline to study week 12) and time2 (study weeks 4-12).||||||.58
72404410|NCT01714310|144315896|SUPERIORITY|||||||0.85||||||Partial linear regression using mixed model, assessing outcome variable over time (baseline to study week 12) and time2 (study weeks 4-12).|Mixed Models Analysis|Time: F=.03, df=1/140||||||.85
72404411|NCT01714310|144315896|SUPERIORITY|||||||0.26||||||Partial linear regression using mixed model, assessing outcome variable over time (baseline to study week 12) and time2 (study weeks 4-12).|Mixed Models Analysis|Time2: F=1.28, df=1/140||||||.26
72404412|NCT01714310|144315897|SUPERIORITY|||||||0.97||||||Group: F=0.00, df=1/44|Mixed Models Analysis|Partial linear regression using mixed model, assessing outcome variable over time (baseline through week 12) and time2 (weeks 4-12).||||||.97
72404413|NCT01714310|144315897|SUPERIORITY||||||<|0.0002||||||Partial linear regression using mixed model, assessing outcome variable over time (baseline to study week 12) and time2 (study weeks 4-12).|Mixed Models Analysis|Time: F=136.22, df=1/44||||||<.0002
72404414|NCT01714310|144315897|SUPERIORITY||||||<|0.0001||||||Partial linear regression using mixed model, assessing outcome variable over time (baseline to study week 12) and time2 (study weeks 4-12).|Mixed Models Analysis|Time2: F=64.90, df=1/44||||||<.0001
72404415|NCT01714310|144315898|SUPERIORITY||||||<|0.0001||||||Time: F=41.85, df=1/89, p\<.0001.|Mixed Models Analysis|Linear regression of outcome change over time within single group.||||||<0.0001
72489958|NCT02187172|144507519|SUPERIORITY||Mean Difference (Final Values)|48.43|STANDARD_ERROR_OF_MEAN|61.62||0.4368|TWO_SIDED|95.0|-76.31|173.16|||Regression, Linear|||Comparison during RCT period||173.16|-76.31|0.4368
72489959|NCT02187172|144507519|SUPERIORITY||Mean Difference (Final Values)|-49.56|STANDARD_ERROR_OF_MEAN|27.84||0.0833|TWO_SIDED|95.0|-105.97|6.85|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment||6.85|-105.97|0.0833
72489960|NCT02187172|144507520|SUPERIORITY||Mean Difference (Final Values)|-0.28|STANDARD_ERROR_OF_MEAN|1.11||0.8036|TWO_SIDED|95.0|-2.52|1.97|||Regression, Linear|||Comparison during RCT period||1.97|-2.52|0.8036
72489961|NCT02187172|144507520|SUPERIORITY||Mean Difference (Final Values)|0.38|STANDARD_ERROR_OF_MEAN|0.51||0.4608|TWO_SIDED|95.0|-0.65|1.4|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment||1.40|-0.65|0.4608
72489962|NCT02187172|144507521|SUPERIORITY||Mean Difference (Final Values)|3320.58|STANDARD_ERROR_OF_MEAN|3414.9||0.337|TWO_SIDED|95.0|-3592.52|10233.67|||Regression, Linear|||Comparison during RCT period||10233.67|-3592.52|0.3370
72568605|NCT04168190|144668502|OTHER|Geometric mean concentration (GMC) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMC Ratio|16.14|||||TWO_SIDED|95.0|6.68|39.01|||||Phase 1: V116 1.0 mL/Phase 1: Pneumovax™23|Serotype 24F||39.01|6.68|
72568606|NCT04168190|144668502|OTHER|Geometric mean concentration (GMC) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMC Ratio|9.14|||||TWO_SIDED|95.0|4.93|16.95|||||Phase 1: V116 0.5 mL/Phase 1: Pneumovax™23|Serotype 31||16.95|4.93|
72404416|NCT01714310|144315899|SUPERIORITY||||||<|0.0001||||||Time: F=26.65, df=1/92, p \<.0001.|Mixed Models Analysis|Linear regression of outcome change over time within single group.||||||<0.0001
72404417|NCT01714310|144315900|SUPERIORITY||||||<|0.0001||||||Time: F=40.35, df=1/89, p \< .0001.|Mixed Models Analysis|Linear regression of outcome change over time within single group.||||||<0.0001
72404418|NCT01714310|144315901|SUPERIORITY||||||<|0.0001||||||Time: F=26.36, df=1/29, p \<.0001.|Mixed Models Analysis|Linear regression of outcome change over time within single group.||||||<0.0001
72404419|NCT01714310|144315902|SUPERIORITY|||||||0.44||||||Group: F=.60, df=1/157|Mixed Models Analysis|Partial linear regression using mixed model, assessing outcome variable over time (baseline to study week 12) and time2 (study weeks 4-12).||||||.44
72404420|NCT01714310|144315902|SUPERIORITY||||||<|0.0001||||||Partial linear regression using mixed model, assessing outcome variable over time (baseline to study week 12) and time2 (study weeks 4-12).|Mixed Models Analysis|Time: F=22.39, df=1/157||||||<.0001
72404421|NCT01714310|144315902|SUPERIORITY|||||||0.04||||||Partial linear regression using mixed model, assessing outcome variable over time (baseline to study week 12) and time2 (study weeks 4-12).|Mixed Models Analysis|Time2: F=4.40, df=1/157||||||.04
72404422|NCT01714310|144315903|SUPERIORITY|||||||0.05||||||Group: F=3.81, df=1/145|Mixed Models Analysis|Partial linear regression using mixed model, assessing outcome variable over time (baseline to study week 12) and time2 (study weeks 4-12).|||No significant group\*time interactions. Group trend likely due to baseline differences.|||.05
72404423|NCT01714310|144315903|SUPERIORITY|||||||0.0001||||||Partial linear regression using mixed model, assessing outcome variable over time (baseline to study week 12) and time2 (study weeks 4-12).|Mixed Models Analysis|Tie: F=15.28, df=1/145||||||.0001
72404424|NCT01714310|144315903|SUPERIORITY|||||||0.02||||||Partial linear regression using mixed model, assessing outcome variable over time (baseline to study week 12) and time2 (study weeks 4-12).|Mixed Models Analysis|Time2: F=5.42, df=1/145||||||.02
72404425|NCT01714310|144315904|SUPERIORITY|||||||0.76|||||||Chi-squared|Chi Square = .10, df=1, p=.76||||||.76
72404426|NCT01714310|144315905|SUPERIORITY|||||||0.38||||||Group: F=.78, df=1/220|Mixed Models Analysis|Partial linear regression using mixed model, assessing outcome variable over time (baseline through week 12) and time2 (weeks 4-12).||||||.38
72404427|NCT01714310|144315905|SUPERIORITY|||||||0.42||||||Partial linear regression using mixed model, assessing outcome variable over time (baseline to study week 12) and time2 (study weeks 4-12).|Mixed Models Analysis|Time: F=.66, df=1/220||||||.42
72489963|NCT02187172|144507521|SUPERIORITY||Mean Difference (Final Values)|6926.25|STANDARD_ERROR_OF_MEAN|2257.84||0.004|TWO_SIDED|95.0|2351.43|11501.07|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment||11501.07|2351.43|0.0040
72489964|NCT02187172|144507522|SUPERIORITY||Mean Difference (Final Values)|-68.95|STANDARD_ERROR_OF_MEAN|131.9||0.6042|TWO_SIDED|95.0|-335.97|198.08|||Regression, Linear|||Comparison during RCT period||198.08|-335.97|0.6042
72489965|NCT02187172|144507522|SUPERIORITY||Mean Difference (Final Values)|-7.96|STANDARD_ERROR_OF_MEAN|85.98||0.9267|TWO_SIDED|95.0|-182.18|166.26|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment||166.26|-182.18|0.9267
72489966|NCT02187172|144507523|SUPERIORITY||Mean Difference (Final Values)|4.2|STANDARD_ERROR_OF_MEAN|5.18||0.4226|TWO_SIDED|95.0|-6.28|14.68|||Regression, Linear|||Comparison during RCT period||14.68|-6.28|0.4226
72489967|NCT02187172|144507523|SUPERIORITY||Mean Difference (Final Values)|3.41|STANDARD_ERROR_OF_MEAN|3.43||0.327|TWO_SIDED|95.0|-3.54|10.36|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment||10.36|-3.54|0.3270
72568607|NCT04168190|144668502|OTHER|Geometric mean concentration (GMC) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMC Ratio|13.58|||||TWO_SIDED|95.0|7.28|25.32|||||Phase 1: V116 1.0 mL/Phase 1: Pneumovax™23|Serotype 31||25.32|7.28|
72489968|NCT02187172|144507524|SUPERIORITY||Mean Difference (Final Values)|-0.49|STANDARD_ERROR_OF_MEAN|1.52||0.7507|TWO_SIDED|95.0|-3.56|2.59|||Regression, Linear|||Comparison during RCT period||2.59|-3.56|0.7507
72489969|NCT02187172|144507524|SUPERIORITY||Mean Difference (Final Values)|-0.07|STANDARD_ERROR_OF_MEAN|0.89||0.9348|TWO_SIDED|95.0|-1.88|1.73|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment||1.73|-1.88|0.9348
72489970|NCT02187172|144507525|SUPERIORITY||Difference of proportions|0.67||||0.0005|TWO_SIDED|95.0|0.45|0.89|||Chi-squared|||||0.89|0.45|0.0005
72516391|NCT05053126|144563941|NON_INFERIORITY|Non-inferiority margin = 10|Mean Difference (Final Values)|3.3|STANDARD_ERROR_OF_MEAN|2.84||0.0099|ONE_SIDED|95.0||8.0|||Mixed Models Analysis|||"The null and alternative hypotheses for evaluating whether pregabalin (L) produced mean responses that show less abuse potential than oxycodone HCl (C) were:~H0: μC - μL ≤ 0.2 (μC - 50) versus Ha: μC - μL \> 0.2 (μC - 50)"||8.0||0.0099
72516392|NCT05053126|144563941|NON_INFERIORITY|Non-inferiority margin = 11|Mean Difference (Final Values)|18.2|STANDARD_ERROR_OF_MEAN|3.13||0.9888|ONE_SIDED|95.0||23.4|||Mixed Models Analysis|||"The null and alternative hypotheses for evaluating whether pregabalin (L) produced mean responses that show abuse potential similar to placebo(P) were:~H0: μL - μp ≥ δ2 versus Ha: μL - μp \< δ2 where δ2 = 11"||23.4||0.9888
72516393|NCT05053126|144563941|NON_INFERIORITY|Non-inferiority margin = 11|Mean Difference (Final Values)|22.0|STANDARD_ERROR_OF_MEAN|3.13||0.9997|ONE_SIDED|95.0||27.1|||Mixed Models Analysis|||"The null and alternative hypotheses for evaluating whether pregabalin (L) produced mean responses that show abuse potential similar to placebo(P) were:~H0: μL - μp ≥ δ2 versus Ha: μL - μp \< δ2 where δ2 = 11"||27.1||0.9997
72516394|NCT05053126|144563942|OTHER||Mean Difference (Final Values)|75.6|STANDARD_ERROR_OF_MEAN|5.948|<|0.0001|TWO_SIDED|90.0|65.79|85.42|||Mixed Models Analysis|||||85.42|65.79|<0.0001
72516395|NCT05053126|144563942|OTHER||Mean Difference (Final Values)|44.84|STANDARD_ERROR_OF_MEAN|5.942|<|0.0001|TWO_SIDED|90.0|35.03|54.65|||Mixed Models Analysis|||||54.65|35.03|<0.0001
72516396|NCT05053126|144563942|OTHER||Mean Difference (Final Values)|49.93|STANDARD_ERROR_OF_MEAN|5.945|<|0.0001|TWO_SIDED|90.0|40.12|59.75|||Mixed Models Analysis|||||59.75|40.12|<0.0001
72516397|NCT05053126|144563942|OTHER||Mean Difference (Final Values)|80.8|STANDARD_ERROR_OF_MEAN|5.942|<|0.0001|TWO_SIDED|90.0|70.99|90.61|||Mixed Models Analysis|||||90.61|70.99|<0.0001
72516398|NCT05053126|144563942|OTHER||Mean Difference (Final Values)|81.91|STANDARD_ERROR_OF_MEAN|5.948|<|0.0001|TWO_SIDED|90.0|72.09|91.73|||Mixed Models Analysis|||||91.73|72.09|<0.0001
72516399|NCT05053126|144563942|OTHER||Mean Difference (Final Values)|-30.8|STANDARD_ERROR_OF_MEAN|5.948|<|0.0001|TWO_SIDED|90.0|-40.6|-20.9|||Mixed Models Analysis|||||-20.9|-40.6|<0.0001
72516400|NCT05053126|144563942|OTHER||Mean Difference (Final Values)|-25.7|STANDARD_ERROR_OF_MEAN|5.942|<|0.0001|TWO_SIDED|90.0|-35.5|-15.9|||Mixed Models Analysis|||||-15.9|-35.5|<0.0001
72568608|NCT04168190|144668502|OTHER|Geometric mean concentration (GMC) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMC Ratio|9.24|||||TWO_SIDED|95.0|5.56|15.36|||||Phase 1: V116 0.5 mL/Phase 1: Pneumovax™23|Serotype 35B||15.36|5.56|
72404428|NCT01714310|144315905|SUPERIORITY|||||||0.13||||||Partial linear regression using mixed model, assessing outcome variable over time (baseline to study week 12) and time2 (study weeks 4-12).|Mixed Models Analysis|Time2: F=.66, df=1/220||||||.13
72404429|NCT01714310|144315906|SUPERIORITY|||||||0.21||||||Group: F=1.56, df=1/222|Mixed Models Analysis|Partial linear regression using mixed model, assessing outcome variable over time (baseline to study week 12) and time2 (study weeks 4-12).||||||.21
72489971|NCT02187172|144507525|OTHER|95% CI of proportion achieving PASI75 at end of study|Proportion|0.72|||||TWO_SIDED|95.0|0.55|0.85||||||||0.85|0.55|
72489972|NCT02187172|144507526|SUPERIORITY||Difference of proportions|0.41||||0.0016|TWO_SIDED|95.0|0.2|0.62|||Chi-squared|||||0.62|0.20|0.0016
72489973|NCT02187172|144507526|OTHER|95% CI of proportion achieving PASI90 at end of study|Proportion|0.49|||||TWO_SIDED|95.0|0.32|0.65||||||||0.65|0.32|
72516401|NCT05053126|144563942|OTHER||Mean Difference (Final Values)|5.2|STANDARD_ERROR_OF_MEAN|5.945||0.3829|TWO_SIDED|90.0|-4.62|15.01|||Mixed Models Analysis|||||15.01|-4.62|0.3829
72516402|NCT05053126|144563942|OTHER||Mean Difference (Final Values)|6.31|STANDARD_ERROR_OF_MEAN|5.942||0.2896|TWO_SIDED|90.0|-3.5|16.11|||Mixed Models Analysis|||||16.11|-3.50|0.2896
72489974|NCT02187172|144507527|SUPERIORITY||Difference of proportions|0.53||||0.0005|TWO_SIDED|95.0|0.29|0.78|||Chi-squared|||Comparison during RCT period for binary Physician Global Assessment||0.78|0.29|0.0005
72489975|NCT02187172|144507527|OTHER|95% CI of proportion achieving PGA clear/almost clear at end of study|Proportion|0.46|||||TWO_SIDED|95.0|0.3|0.63||||||||0.63|0.30|
72489976|NCT02187172|144507528|SUPERIORITY||Mean Difference (Final Values)|8.32|STANDARD_ERROR_OF_MEAN|6.3||0.1944|TWO_SIDED|95.0|-4.42|21.06|||Regression, Linear|||||21.06|-4.42|0.1944
72516403|NCT05053126|144563943|OTHER||Mean Difference (Final Values)|23.47|STANDARD_ERROR_OF_MEAN|2.247|<|0.0001|TWO_SIDED|90.0|19.77|27.17|||Mixed Models Analysis|||||27.17|19.77|<0.0001
72516404|NCT05053126|144563943|OTHER||Mean Difference (Final Values)|10.4|STANDARD_ERROR_OF_MEAN|2.239|<|0.0001|TWO_SIDED|90.0|6.71|14.09|||Mixed Models Analysis|||||14.09|6.71|<0.0001
72516405|NCT05053126|144563943|OTHER||Mean Difference (Final Values)|11.29|STANDARD_ERROR_OF_MEAN|2.248|<|0.0001|TWO_SIDED|90.0|7.59|14.99|||Mixed Models Analysis|||||14.99|7.59|<0.0001
72516406|NCT05053126|144563943|OTHER||Mean Difference (Final Values)|24.33|STANDARD_ERROR_OF_MEAN|2.251|<|0.0001|TWO_SIDED|90.0|20.62|28.03|||Mixed Models Analysis|||||28.03|20.62|<0.0001
72516407|NCT05053126|144563943|OTHER||Mean Difference (Final Values)|22.34|STANDARD_ERROR_OF_MEAN|2.245|<|0.0001|TWO_SIDED|90.0|18.65|26.04|||Mixed Models Analysis|||||26.04|18.65|<0.0001
72516408|NCT05053126|144563943|OTHER||Mean Difference (Final Values)|-13.1|STANDARD_ERROR_OF_MEAN|2.245|<|0.0001|TWO_SIDED|90.0|-16.8|-9.38|||Mixed Models Analysis|||||-9.38|-16.8|<0.0001
72516409|NCT05053126|144563943|OTHER||Mean Difference (Final Values)|-12.2|STANDARD_ERROR_OF_MEAN|2.252|<|0.0001|TWO_SIDED|90.0|-15.9|-8.47|||Mixed Models Analysis|||||-8.47|-15.9|<0.0001
72516410|NCT05053126|144563943|OTHER||Mean Difference (Final Values)|0.86|STANDARD_ERROR_OF_MEAN|2.258||0.7051|TWO_SIDED|90.0|-2.86|4.57|||Mixed Models Analysis|||||4.57|-2.86|0.7051
72404430|NCT01714310|144315906|SUPERIORITY||||||<|0.0001||||||Partial linear regression using mixed model, assessing outcome variable over time (baseline to study week 12) and time2 (study weeks 4-12).|Mixed Models Analysis|Time: F=63.11, df=1/222||||||<.0001
72404431|NCT01714310|144315906|SUPERIORITY|||||||0.0004||||||Partial linear regression using mixed model, assessing outcome variable over time (baseline to study week 12) and time2 (study weeks 4-12).|Mixed Models Analysis|Time2: F=12.86, df=1/222||||||.0004
72404432|NCT01714310|144315907|SUPERIORITY|||||||0.02||||||Group: F=5.42, df=1/223|Mixed Models Analysis|Partial linear regression using mixed model, assessing outcome variable over time (baseline to study week 12) and time2 (study weeks 4-12).||||||.02
72489977|NCT02187172|144507528|SUPERIORITY||Mean Difference (Final Values)|-12.33|STANDARD_ERROR_OF_MEAN|3.5||0.0011|TWO_SIDED|95.0|-19.4|-5.25|||Regression, Linear|||||-5.25|-19.40|0.0011
72489978|NCT02187172|144507529|SUPERIORITY||Mean Difference (Final Values)|-779.59|STANDARD_ERROR_OF_MEAN|1049.99||0.4628|TWO_SIDED|95.0|-2911.19|1352.01|||Regression, Linear|||||1352.01|-2911.19|0.4628
72516411|NCT05053126|144563943|OTHER||Mean Difference (Final Values)|-1.13|STANDARD_ERROR_OF_MEAN|2.246||0.616|TWO_SIDED|90.0|-4.82|2.57|||Mixed Models Analysis|||||2.57|-4.82|0.6160
72516412|NCT05053126|144563944|OTHER||Mean Difference (Final Values)|21.99|STANDARD_ERROR_OF_MEAN|2.235|<|0.0001|TWO_SIDED|90.0|18.31|25.67|||Mixed Models Analysis|||||25.67|18.31|<0.0001
72516413|NCT05053126|144563944|OTHER||Mean Difference (Final Values)|6.4|STANDARD_ERROR_OF_MEAN|2.227||0.0042|TWO_SIDED|90.0|2.73|10.07|||Mixed Models Analysis|||||10.07|2.73|0.0042
72516414|NCT05053126|144563944|OTHER||Mean Difference (Final Values)|9.8|STANDARD_ERROR_OF_MEAN|2.236|<|0.0001|TWO_SIDED|90.0|6.12|13.48|||Mixed Models Analysis|||||13.48|6.12|<0.0001
72516415|NCT05053126|144563944|OTHER||Mean Difference (Final Values)|21.12|STANDARD_ERROR_OF_MEAN|2.239|<|0.0001|TWO_SIDED|90.0|17.44|24.81|||Mixed Models Analysis|||||24.81|17.44|<0.0001
72516416|NCT05053126|144563944|OTHER||Mean Difference (Final Values)|21.27|STANDARD_ERROR_OF_MEAN|2.233|<|0.0001|TWO_SIDED|90.0|17.59|24.95|||Mixed Models Analysis|||||24.95|17.59|<0.0001
72516417|NCT05053126|144563944|OTHER||Mean Difference (Final Values)|-15.6|STANDARD_ERROR_OF_MEAN|2.233|<|0.0001|TWO_SIDED|90.0|-19.3|-11.9|||Mixed Models Analysis|||||-11.9|-19.3|<0.0001
72516418|NCT05053126|144563944|OTHER||Mean Difference (Final Values)|-12.2|STANDARD_ERROR_OF_MEAN|2.24|<|0.0001|TWO_SIDED|90.0|-15.9|-8.5|||Mixed Models Analysis|||||-8.50|-15.9|<0.0001
72516419|NCT05053126|144563944|OTHER||Mean Difference (Final Values)|-0.87|STANDARD_ERROR_OF_MEAN|2.246||0.7001|TWO_SIDED|90.0|-4.56|2.83|||Mixed Models Analysis|||||2.83|-4.56|0.7001
72516420|NCT05053126|144563944|OTHER||Mean Difference (Final Values)|-0.72|STANDARD_ERROR_OF_MEAN|2.233||0.7479|TWO_SIDED|90.0|-4.4|2.96|||Mixed Models Analysis|||||2.96|-4.40|0.7479
72516421|NCT05053126|144563945|OTHER||Mean Difference (Final Values)|27.82|STANDARD_ERROR_OF_MEAN|1.439|<|0.0001|TWO_SIDED|90.0|25.45|30.19|||Mixed Models Analysis|||||30.19|25.45|<0.0001
72404433|NCT01714310|144315907|SUPERIORITY|||||||0.18||||||Partial linear regression using mixed model, assessing outcome variable over time (baseline to study week 12) and time2 (study weeks 4-12).|Mixed Models Analysis|Time: F=1.77, df=1/223||||||.18
72404434|NCT01714310|144315907|SUPERIORITY|||||||0.49||||||Partial linear regression using mixed model, assessing outcome variable over time (baseline to study week 12) and time2 (study weeks 4-12).|Mixed Models Analysis|Time2: F=.47, df=1/223||||||.49
72404435|NCT01714310|144315908|SUPERIORITY|||||||0.9||||||Group: F=.02, df=1/223|Mixed Models Analysis|Partial linear regression using mixed model, assessing outcome variable over time (baseline to study week 12) and time2 (study weeks 4-12).||||||.90
72489979|NCT02187172|144507529|SUPERIORITY||Mean Difference (Final Values)|-910.84|STANDARD_ERROR_OF_MEAN|729.96||0.2209|TWO_SIDED|95.0|-2395.95|574.27|||Regression, Linear|||||574.27|-2395.95|0.2209
72489980|NCT01035099|144507542|SUPERIORITY|||||||0.31|||||||t-test, 2 sided|Nonparametric Wilcoxon rank-sum test confirmed these results.||||||0.31
72489981|NCT01035099|144507543|SUPERIORITY|||||||0.19|||||||t-test, 2 sided|Nonparametric Wilcoxon rank-sum test confirmed these results.||||||0.19
72489982|NCT01035099|144507546|SUPERIORITY|||||||0.12|||||||t-test, 2 sided|Nonparametric Wilcoxon rank-sum test confirmed these results.||||||0.12
72489983|NCT01035099|144507547|SUPERIORITY|||||||0.77|||||||t-test, 2 sided|Nonparametric Wilcoxon rank-sum test confirmed these results.||||||0.77
72516422|NCT05053126|144563945|OTHER||Mean Difference (Final Values)|14.53|STANDARD_ERROR_OF_MEAN|1.435|<|0.0001|TWO_SIDED|90.0|12.17|16.89|||Mixed Models Analysis|||||16.89|12.17|<0.0001
72516423|NCT05053126|144563945|OTHER||Mean Difference (Final Values)|17.85|STANDARD_ERROR_OF_MEAN|1.437|<|0.0001|TWO_SIDED|90.0|15.49|20.22|||Mixed Models Analysis|||||20.22|15.49|<0.0001
72516424|NCT05053126|144563945|OTHER||Mean Difference (Final Values)|34.4|STANDARD_ERROR_OF_MEAN|1.438|<|0.0001|TWO_SIDED|90.0|34.4|36.77|||Mixed Models Analysis|||||36.77|34.40|<0.0001
72516425|NCT05053126|144563945|OTHER||Mean Difference (Final Values)|38.84|STANDARD_ERROR_OF_MEAN|1.44|<|0.0001|TWO_SIDED|90.0|36.47|41.21|||Mixed Models Analysis|||||41.21|36.47|<0.0001
72516426|NCT05053126|144563945|OTHER||Mean Difference (Final Values)|-13.3|STANDARD_ERROR_OF_MEAN|1.434|<|0.0001|TWO_SIDED|90.0|-15.6|-10.9|||Mixed Models Analysis|||||-10.9|-15.6|<0.0001
72516427|NCT05053126|144563945|OTHER||Mean Difference (Final Values)|-9.97|STANDARD_ERROR_OF_MEAN|1.435|<|0.0001|TWO_SIDED|90.0|-12.3|-7.61|||Mixed Models Analysis|||||-7.61|-12.3|<0.0001
72516428|NCT05053126|144563945|OTHER||Mean Difference (Final Values)|6.58|STANDARD_ERROR_OF_MEAN|1.436|<|0.0001|TWO_SIDED|90.0|4.22|8.94|||Mixed Models Analysis|||||8.94|4.22|<0.0001
72516429|NCT05053126|144563945|OTHER||Mean Difference (Final Values)|11.02|STANDARD_ERROR_OF_MEAN|1.436|<|0.0001|TWO_SIDED|90.0|8.65|13.38|||Mixed Models Analysis|||||13.38|8.65|<0.0001
72516430|NCT01309841|144563962|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.38||||0.015|TWO_SIDED|95.0|1.062|1.795|||Cochran-Mantel-Haenszel|||Analysis via Cochran Mantel-Haenszel test stratified by response to laxatives at baseline (LIR, LAR, LUR).||1.795|1.062|0.015
72489984|NCT01035099|144507548|SUPERIORITY|||||||0.63|||||||t-test, 2 sided|Nonparametric Wilcoxon rank-sum test confirmed these results.||||||0.63
72489985|NCT01035099|144507550|SUPERIORITY|||||||0.14|||||||t-test, 2 sided|Nonparametric Wilcoxon rank-sum test confirmed these results.||||||0.14
72489986|NCT01035099|144507551|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|Nonparametric Wilcoxon rank-sum test confirmed these results.||||||<0.0001
72489987|NCT01035099|144507552|SUPERIORITY|||||||0.58|||||||t-test, 2 sided|Nonparametric Wilcoxon rank-sum test confirmed these results.||||||0.58
72516431|NCT01309841|144563962|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.509||||0.001|TWO_SIDED|95.0|1.168|1.949|||Cochran-Mantel-Haenszel|||Analysis via Cochran Mantel-Haenszel test stratified by response to laxatives at baseline (LIR, LAR, LUR).||1.949|1.168|0.001
72516432|NCT01309841|144563963|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.479||||0.028|TWO_SIDED|95.0|1.038|2.107||Response rate over Weeks 1 to 12 in the LIR subgroup is a key secondary endpoint included in the multiple testing procedure.|Cochran-Mantel-Haenszel|||||2.107|1.038|0.028
72516433|NCT01309841|144563963|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.691||||0.002|TWO_SIDED|95.0|1.205|2.373||Response rate over Weeks 1 to 12 in the LIR subgroup is a key secondary endpoint included in the multiple testing procedure.|Cochran-Mantel-Haenszel|||||2.373|1.205|0.002
72516434|NCT01309841|144563965|SUPERIORITY_OR_OTHER||LS mean difference|0.55|||<|0.001|TWO_SIDED|95.0|0.24|0.86|||Mixed Models Analysis|||Analysis via Mixed Model Repeated Measures (MMRM) with fixed effects for baseline, baseline laxative response, treatment and treatment time interaction. Study pooled center is included as a random effect.||0.86|0.24|<0.001
72516435|NCT01309841|144563965|SUPERIORITY_OR_OTHER||Ls mean difference|0.82|||<|0.001|TWO_SIDED|95.0|0.51|1.13|||Mixed Models Analysis|||Analysis via MMRM with fixed effects for baseline, baseline laxative response, treatment and treatment time interaction. Study pooled center is included as a random effect.||1.13|0.51|<0.001
72516436|NCT01309841|144563966|SUPERIORITY_OR_OTHER||LS mean difference|-0.09||||0.176|TWO_SIDED|95.0|-0.23|0.04|||Mixed Models Analysis|||Analysis via MMRM with fixed effects for baseline, baseline laxative response (LIR, non-LIR), treatment and treatment time interaction. Study pooled center is included as a random effect.||0.04|-0.23|0.176
72516437|NCT01309841|144563966|SUPERIORITY_OR_OTHER||LS mean difference|-0.18||||0.008|TWO_SIDED|95.0|-0.32|-0.05|||Mixed Models Analysis|||Analysis via MMRM with fixed effects for baseline, baseline laxative response (LIR, non-LIR), treatment and treatment time interaction. Study pooled center is included as a random effect.||-0.05|-0.32|0.008
72516438|NCT01309841|144563967|SUPERIORITY_OR_OTHER||LS mean difference|0.05||||0.564|TWO_SIDED|95.0|-0.12|0.23|||Mixed Models Analysis|||Analysis via MMRM with fixed effects for baseline, baseline laxative response (LIR, non-LIR), treatment and treatment time interaction. Study pooled center is included as a random effect.||0.23|-0.12|0.564
72516439|NCT01309841|144563967|SUPERIORITY_OR_OTHER||LS mean difference|0.18||||0.042|TWO_SIDED|95.0|0.01|0.36|||Mixed Models Analysis|||Analysis via MMRM with fixed effects for baseline, baseline laxative response (LIR, non-LIR), treatment and treatment time interaction. Study pooled center is included as a random effect.||0.36|0.01|0.042
72568609|NCT04168190|144668502|OTHER|Geometric mean concentration (GMC) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMC Ratio|12.5|||||TWO_SIDED|95.0|7.49|20.87|||||Phase 1: V116 1.0 mL/Phase 1: Pneumovax™23|Serotype 35B||20.87|7.49|
72489988|NCT01035099|144507554|SUPERIORITY|||||||0.42|||||||t-test, 2 sided|Nonparametric Wilcoxon rank-sum test confirmed these results.||||||0.42
72489989|NCT01438489|144507581|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.38||||0.014|TWO_SIDED|90.0|1.33|4.26|||Regression, Logistic|||All-comers||4.26|1.33|0.014
72489990|NCT01438489|144507581|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.94||||0.063|TWO_SIDED|90.0|1.08|3.49|||Regression, Logistic|||All-comers||3.49|1.08|0.063
72489991|NCT01438489|144507582|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.55||||0.004|TWO_SIDED|90.0|1.72|7.32|||Regression, Logistic|||High||7.32|1.72|0.004
72489992|NCT01438489|144507582|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.65||||0.029|TWO_SIDED|90.0|1.27|5.53|||Regression, Logistic|||High||5.53|1.27|0.029
72489993|NCT01324232|144507611|SUPERIORITY||Pearson correlation|0.0019|||=|0.9827|TWO_SIDED||||||t-test, 2 sided|||The null hypothesis that the true correlation between the change from Baseline PRS scores and the DM plasma concentration was equal to zero and was tested using a 2-sided test at the 5% level of significance within active treatment groups. The regression line was fitted using change from baseline in average PRS during Day 57-84 as the dependent variable and the average of log-transformed DM Plasma Concentration at Day 22 and Day 50 as the independent variable.||||= 0.9827
72489994|NCT01324232|144507613|SUPERIORITY||||||=|0.8869|||||||ANCOVA|||Test of dose trend (overall P value)||||=0.8869
72489995|NCT01324232|144507613|SUPERIORITY||Adjusted mean difference|-0.04|STANDARD_ERROR_OF_MEAN|0.46|=|0.9381|TWO_SIDED|95.0|-0.94|0.87|||ANCOVA|||Pairwise treatment group vs placebo||0.87|-0.94|=0.9381
72516440|NCT01309841|144563968|SUPERIORITY_OR_OTHER||LS mean difference|3.87||||0.094|TWO_SIDED|95.0|-0.66|8.39|||Mixed Models Analysis|||Analysis via MMRM with fixed effects for baseline, baseline laxative response (LIR, non-LIR), treatment and treatment time interaction. Study pooled center is included as a random effect.||8.39|-0.66|0.094
72516441|NCT01309841|144563968|SUPERIORITY_OR_OTHER||LS mean difference|8.59|||<|0.001|TWO_SIDED|95.0|4.04|13.14|||Mixed Models Analysis|||Analysis via MMRM with fixed effects for baseline, baseline laxative response (LIR, non-LIR), treatment and treatment time interaction. Study pooled center is included as a random effect.||13.14|4.04|<0.001
72516442|NCT01309841|144563969|SUPERIORITY_OR_OTHER||LS mean difference|0.54||||0.011|TWO_SIDED|95.0|0.12|0.96|||Mixed Models Analysis|||Analysis via MMRM with fixed effects for baseline, baseline laxative response (LIR, non-LIR), treatment and treatment time interaction. Study pooled center is included as a random effect.||0.96|0.12|0.011
72568610|NCT04168190|144668503|OTHER|Geometric mean titer (GMT) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMT Ratio|0.99|||||TWO_SIDED|95.0|0.67|1.47|||||Phase 1: V116 0.5 mL/Phase 1: Pneumovax™23|Serotype 3||1.47|0.67|
72404436|NCT01714310|144315908|SUPERIORITY|||||||0.21||||||Partial linear regression using mixed model, assessing outcome variable over time (baseline to study week 12) and time2 (study weeks 4-12).|Mixed Models Analysis|Time: F=1.60, df=1/223||||||.21
72404437|NCT01714310|144315908|SUPERIORITY|||||||0.73||||||Partial linear regression using mixed model, assessing outcome variable over time (baseline to study week 12) and time2 (study weeks 4-12).|Mixed Models Analysis|Time2: F=.12, df=1/223||||||.73
72489996|NCT01324232|144507613|SUPERIORITY||Adjusted mean difference|-0.38|STANDARD_ERROR_OF_MEAN|0.46|=|0.4128|TWO_SIDED|95.0|-1.28|0.53|||ANCOVA|||Pairwise treatment group vs placebo||0.53|-1.28|=0.4128
72489997|NCT01324232|144507613|SUPERIORITY||Adjusted mean difference|0.03|STANDARD_ERROR_OF_MEAN|0.461|=|0.9427|TWO_SIDED|95.0|-0.88|0.94|||ANCOVA|||Pairwise treatment group vs placebo||0.94|-0.88|=0.9427
72489998|NCT01324232|144507613|SUPERIORITY||Adjusted mean difference|-0.21|STANDARD_ERROR_OF_MEAN|0.401|=|0.6075|TWO_SIDED|95.0|-1.0|0.58|||ANCOVA|||Pairwise treatment group vs placebo||0.58|-1.0|=0.6075
72489999|NCT01324232|144507613|SUPERIORITY||Adjusted mean difference|-0.17|STANDARD_ERROR_OF_MEAN|0.402|=|0.669|TWO_SIDED|95.0|-0.96|0.62|||ANCOVA|||Pairwise treatment group vs placebo||0.62|-0.96|=0.6690
72490000|NCT01324232|144507613|SUPERIORITY||Adjusted mean difference|-0.13|STANDARD_ERROR_OF_MEAN|0.38|=|0.7394|TWO_SIDED|95.0|-0.88|0.62|||ANCOVA|||Pairwise treatment group vs placebo||0.62|-0.88|=0.7394
72490001|NCT01324232|144507614|SUPERIORITY||||||=|0.9731|TWO_SIDED|||||The p-value presented tests the hypothesis for overall treatment effect versus no treatment effect.|ANCOVA|||||||=0.9731
72490002|NCT01324232|144507614|SUPERIORITY||Mean difference (final values)|1.32|STANDARD_ERROR_OF_MEAN|2.42|||TWO_SIDED|95.0|-3.46|6.09||||||||6.09|-3.46|
72490003|NCT01324232|144507614|SUPERIORITY||Mean difference (final values)|-3.0|STANDARD_ERROR_OF_MEAN|2.394|||TWO_SIDED|95.0|-7.72|1.72||||||||1.72|-7.72|
72490004|NCT01324232|144507614|SUPERIORITY||Mean difference (final values)|1.2|STANDARD_ERROR_OF_MEAN|2.408|||TWO_SIDED|95.0|-3.54|5.95||||||||5.95|-3.54|
72490005|NCT01324232|144507616|SUPERIORITY||||||=|0.4778||||||The p-value presented tests the hypothesis for overall treatment effect versus no treatment effect.|ANCOVA|||The p-value presented tests the hypothesis for overall treatment effect versus no treatment effect.||||=0.4778
72490006|NCT01324232|144507616|SUPERIORITY||Adjusted mean difference|0.49|STANDARD_ERROR_OF_MEAN|3.676|||TWO_SIDED|95.0|-6.76|7.74||||||||7.74|-6.76|
72490007|NCT01324232|144507616|SUPERIORITY||Adjusted mean difference|-1.67|STANDARD_ERROR_OF_MEAN|3.663|||TWO_SIDED|95.0|-8.89|5.56||||||||5.56|-8.89|
72490008|NCT01324232|144507616|SUPERIORITY||Adjusted mean difference|3.43|STANDARD_ERROR_OF_MEAN|3.681|||TWO_SIDED|95.0|-3.83|10.68||||||||10.68|-3.83|
72490009|NCT01324232|144507617|SUPERIORITY||||||=|0.0685|TWO_SIDED|||||The p-value presented tests the hypothesis for overall treatment effect versus no treatment effect.|ANCOVA|||||||=0.0685
72490010|NCT01324232|144507617|SUPERIORITY||Mean difference (final values)|-0.51|STANDARD_ERROR_OF_MEAN|0.68|||TWO_SIDED|95.0|-1.85|0.83||||||||0.83|-1.85|
72490011|NCT01324232|144507617|SUPERIORITY||Mean difference (final values)|-0.85|STANDARD_ERROR_OF_MEAN|0.677|||TWO_SIDED|95.0|-2.19|0.48||||||||0.48|-2.19|
72490012|NCT01324232|144507617|SUPERIORITY||Mean difference (final values)|-1.2|STANDARD_ERROR_OF_MEAN|0.681|||TWO_SIDED|95.0|-2.54|0.15||||||||0.15|-2.54|
72490013|NCT01324232|144507618|SUPERIORITY||||||=|0.4201|TWO_SIDED|||||The p-value presented tests the hypothesis for overall treatment effect versus no treatment effect.|ANCOVA|||||||=0.4201
72490014|NCT01324232|144507618|SUPERIORITY||Adjusted mean difference|-0.49|STANDARD_ERROR_OF_MEAN|1.473|||TWO_SIDED|95.0|-3.4|2.41||||||||2.41|-3.40|
72490015|NCT01324232|144507618|SUPERIORITY||Adjusted mean difference|-0.9|STANDARD_ERROR_OF_MEAN|1.454|||TWO_SIDED|95.0|-3.76|1.97||||||||1.97|-3.76|
72490016|NCT01324232|144507618|SUPERIORITY||Adjusted mean difference|1.46|STANDARD_ERROR_OF_MEAN|1.46|||TWO_SIDED|95.0|-1.42|4.34||||||||4.34|-1.42|
72404438|NCT01714310|144315909|SUPERIORITY|||||||0.15||||||Group: F=2.05, df=1/223|Mixed Models Analysis|Partial linear regression using mixed model, assessing outcome variable over time (baseline to study week 12) and time2 (study weeks 4-12).||||||.15
72404439|NCT01714310|144315909|SUPERIORITY|||||||0.59||||||Partial linear regression using mixed model, assessing outcome variable over time (baseline to study week 12) and time2 (study weeks 4-12).|Mixed Models Analysis|Time: F=.29, df=1/223||||||.59
72404440|NCT01714310|144315909|SUPERIORITY|||||||0.14||||||Partial linear regression using mixed model, assessing outcome variable over time (baseline to study week 12) and time2 (study weeks 4-12).|Mixed Models Analysis|Time2: F=2.15, df=1/223||||||.14
72490017|NCT01324232|144507619|SUPERIORITY||||||=|0.8068||||||The p-value presented tests the hypothesis for overall treatment effect versus no treatment effect.|ANCOVA|||The p-value presented tests the hypothesis for overall treatment effect versus no treatment effect.||||=0.8068
72490018|NCT01324232|144507619|SUPERIORITY||Adjusted mean difference|-1.1|STANDARD_ERROR_OF_MEAN|1.205|||TWO_SIDED|95.0|-3.47|1.28||||||||1.28|-3.47|
72490019|NCT01324232|144507619|SUPERIORITY||Adjusted mean difference|-0.63|STANDARD_ERROR_OF_MEAN|1.2|||TWO_SIDED|95.0|-2.99|1.74||||||||1.74|-2.99|
72490020|NCT01324232|144507619|SUPERIORITY||Adjusted mean difference|0.31|STANDARD_ERROR_OF_MEAN|1.207|||TWO_SIDED|95.0|-2.07|2.69||||||||2.69|-2.07|
72490021|NCT01324232|144507620|SUPERIORITY||||||=|0.6315||||||The p-value presented tests the hypothesis for overall treatment effect versus no treatment effect. Oral responses.|ANCOVA|||||||=0.6315
72490022|NCT01324232|144507620|SUPERIORITY||Adjusted mean difference|2.37|STANDARD_ERROR_OF_MEAN|2.772|||TWO_SIDED|95.0|-3.19|7.93||||||||7.93|-3.19|
72490023|NCT01324232|144507620|SUPERIORITY||Adjusted mean difference|1.31|STANDARD_ERROR_OF_MEAN|2.562|||TWO_SIDED|95.0|-3.83|6.45||||||||6.45|-3.83|
72490024|NCT01324232|144507620|SUPERIORITY||Adjusted mean difference|1.46|STANDARD_ERROR_OF_MEAN|2.728|||TWO_SIDED|95.0|-4.01|6.94||||||||6.94|-4.01|
72490025|NCT01324232|144507620|SUPERIORITY||||||=|0.1485|TWO_SIDED|||||P-value presented tests the hypothesis for overall treatment effect versus no treatment effect. Written responses.|ANCOVA|||||||=0.1485
72490026|NCT01324232|144507620|SUPERIORITY||Mean difference (final values)|1.77|STANDARD_ERROR_OF_MEAN|1.558|||TWO_SIDED|95.0|-1.31|4.85||||||||4.85|-1.31|
72490027|NCT01324232|144507620|SUPERIORITY||Mean difference (final values)|-1.68|STANDARD_ERROR_OF_MEAN|1.605|||TWO_SIDED|95.0|-4.86|1.49||||||||1.49|-4.86|
72490028|NCT01324232|144507620|SUPERIORITY||Mean difference (final values)|-1.65|STANDARD_ERROR_OF_MEAN|1.549|||TWO_SIDED|95.0|-4.71|1.41||||||||1.41|-4.71|
72490029|NCT01324232|144507621|SUPERIORITY||||||=|0.1404|TWO_SIDED||||||t-test, 2 sided|||The null hypothesis is that the true correlation between NRS scores and DM plasma concentration is equal to zero. Only 158 of the 209 participants in the mITT Population were analyzed at Day 22.||||=0.1404
72490030|NCT01324232|144507621|SUPERIORITY||||||=|0.0805|TWO_SIDED||||||t-test, 2 sided|||The null hypothesis that the true correlation between NRS scores and DM plasma concentration is equal to zero. Only 152 of the 209 participants in the mITT Population were analyzed at Day 50.||||=0.0805
72490031|NCT01324232|144507621|SUPERIORITY||||||=|0.0551|TWO_SIDED||||||t-test, 2 sided|||The null hypothesis that the true correlation between NRS scores and DM plasma concentration is equal to zero. Only 185 of the 209 participants in the mITT Population were analyzed at Day 85.||||=0.0551
72490032|NCT01324232|144507622|SUPERIORITY||||||=|0.9207|TWO_SIDED|||||The p-value presented tests the hypothesis for overall treatment effect versus no treatment effect.|ANCOVA|||||||=0.9207
72490033|NCT03503877|144507628|SUPERIORITY|||||||0.07|||||||Wilcoxon signed-rank testing|||||||0.07
72568611|NCT04168190|144668503|OTHER|Geometric mean titer (GMT) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMT Ratio|1.06|||||TWO_SIDED|95.0|0.72|1.57|||||Phase 1: V116 1.0 mL/Phase 1: Pneumovax™23|Serotype 3||1.57|0.72|
72490034|NCT03503877|144507629|SUPERIORITY|||||||0.89|||||||Wilcoxon signed-rank testing|||||||0.89
72490035|NCT03503877|144507630|SUPERIORITY|||||||0.54||||||High mosaicism|Wilcoxon signed-rank testing|||||||0.54
72490036|NCT03503877|144507630|SUPERIORITY|||||||0.2||||||Low mosaicism|Wilcoxon signed-rank|||||||.20
72490037|NCT03503877|144507631|SUPERIORITY|||||||0.01||||||Time to Expanded Blastocyst|Wilcoxon signed-rank testing|||||||0.01
72490038|NCT04962022|144507632|OTHER|PF-07321332/ritonavir administered alone was the Reference treatment and PF-07321332/ritonavir co-administered with itraconazole was the Test treatment.|Specified in comments|118.57||||0.05|TWO_SIDED|90.0|112.5|124.97|||Mixed Models Analysis||"Mixed Model was fitted to obtain:~1.Ratio of geometric means 2.90% CI of ratio of geometric means"|||124.97|112.50|0.05
72490039|NCT04962022|144507633|OTHER|PF-07321332/ritonavir administered alone was the Reference treatment and PF-07321332/ritonavir co-administered with itraconazole was the Test treatment.|Specified in comments|138.82||||0.05|TWO_SIDED|90.0|129.25|149.11|||Mixed Models Analysis||"Mixed Model was fitted to obtain:~1.Ratio of geometric means 2.90% CI of ratio of geometric means"|||149.11|129.25|0.05
72490040|NCT01146873|144507648|NON_INFERIORITY_OR_EQUIVALENCE|The null hypothesis is that efavirenz is inferior to ritonavir-boosted lopinavir.|Risk Difference (RD)|0.107|||<|0.001|TWO_SIDED||||||Kaplan-Meier methods|||||||<0.001
72490041|NCT01146873|144507649|NON_INFERIORITY_OR_EQUIVALENCE|The null hypothesis is that efavirenz is inferior to ritonavir-boosted lopinavir.|Risk Difference (RD)|-0.007|||<|0.001|TWO_SIDED||||||Kaplan-Meier methods|||||||<0.001
72490042|NCT01146873|144507650|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||t-test, 2 sided|||||||<0.001
72490043|NCT01146873|144507652|SUPERIORITY_OR_OTHER|||||||0.003|TWO_SIDED||||||Chi-squared|||||||0.003
72490044|NCT01594515|144507705|SUPERIORITY_OR_OTHER||Slope|0.9702|STANDARD_ERROR_OF_MEAN|0.0151|||TWO_SIDED|95.0|0.94|1.0005|||||Dose proportionality was explored using the power model (ANCOVA). The perfect dose proportionality would correspond to a slope β of 1. PK endpoints on the log-transformed scale.|This was non confirmatory testing (Single dose). Dose proportionality of the drug for Cmax was analysed.(N=50)||1.0005|0.9400|
72490045|NCT01594515|144507706|SUPERIORITY_OR_OTHER||Slope|1.0442|STANDARD_ERROR_OF_MEAN|0.0148|||TWO_SIDED|95.0|1.0145|1.074|||||"Dose proportionality was explored using the power model (ANCOVA). The perfect dose proportionality would correspond to a slope β of 1.~PK endpoints on the log-transformed scale."|This was non confirmatory testing (Single dose). Dose proportionality of the drug for AUC0-inf was analysed. (N=48)||1.0740|1.0145|
72490046|NCT00841789|144507747|SUPERIORITY|||||||0.1|||||||Chi-squared|||||||.10
72490047|NCT00841789|144507748|SUPERIORITY|||||||0.86|||||||Regression, Cox|||We applied a Generalized Estimating Equation (GEE) model to determine z score change values (see Protocol page 36 in Supplement).||||0.86
72490048|NCT00841789|144507749|SUPERIORITY|||||||0.83|||||||GEE|||General Estimating Equation||||.83
72490049|NCT00841789|144507749|OTHER|Generallzed Estimating Equation was used for z-score change within groups compared to baseline|General Estimating Equation|||||0.1279|||||||GEE|||We analyzed change from baseline for both etanercept and placebo. LS mean change J(standard error) reported||||0.1279
72490050|NCT00841789|144507750|OTHER|General Estimating Equation for 3 coronary arteries.||||||0.03|||||||GEE|||General Estimating Equation|Generalize estimating equation for 3 coronary arteries evaluated in each patient by echocardiography|||0.03
72490051|NCT00841789|144507750|OTHER|see above||||||0.619|||||||GEE|||GEE performed to compare with change in coronary z score from baseline||||0.619
72490052|NCT02290873|144507764|SUPERIORITY||Difference in Rates|0.8961|||<|0.0001|TWO_SIDED|95.0|0.8505|0.9416||P-value calculated from a Cochran-Mantel-Haenszel test accounting for fentanyl strata.|Cochran-Mantel-Haenszel|||||0.9416|0.8505|<0.0001
72490053|NCT02290873|144507765|SUPERIORITY||Hazard Ratio (HR)|6.133|||<|0.0001|TWO_SIDED|95.0|4.416|8.517|||Log Rank|||||8.517|4.416|<0.0001
72568612|NCT04168190|144668503|OTHER|Geometric mean titer (GMT) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMT Ratio|0.88||||||95.0|0.54|1.42|||||Phase 1: V116 0.5 mL/Phase 1: Pneumovax™23|Serotype 7F||1.42|0.54|
72568613|NCT04168190|144668503|OTHER|Geometric mean titer (GMT) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMT Ratio|1.11|||||TWO_SIDED|95.0|0.68|1.8|||||Phase 1: V116 1.0 mL/Phase 1: Pneumovax™23|Serotype 7F||1.80|0.68|
72404441|NCT02822508|144315913|SUPERIORITY|||||||0.034|||||||Cochran-Mantel-Haenszel|||||||0.034
72490054|NCT01519765|144507784|SUPERIORITY_OR_OTHER|||||||0.1611|||||||Fisher Exact|||A consecutive sample will be used as women are recruited. Based on an 80% power and an alpha of 0.05, a sample size of 103 subjects in each arm is required to detect a 20% difference between deliveries within 24hrs between the two treatment arms. An effect size of 20% was selected as this is thought to be a clinically significant difference. This is based on the Wing study showing 50% delivery within 24 hrs with vaginal misoprostol.||||0.1611
72490055|NCT01519765|144507785|SUPERIORITY_OR_OTHER|||||||0.018|TWO_SIDED||||||t-test, 2 sided|||||||0.018
72490056|NCT01519765|144507786|SUPERIORITY_OR_OTHER|||||||0.0623|||||||Kruskal-Wallis|||||||0.0623
72490057|NCT01519765|144507787|SUPERIORITY_OR_OTHER|||||||0.1141|TWO_SIDED||||||Kruskal-Wallis|||||||0.1141
72490058|NCT01519765|144507788|SUPERIORITY_OR_OTHER|||||||0.4469|TWO_SIDED||||||Fisher Exact|||||||0.4469
72516443|NCT01309841|144563969|SUPERIORITY_OR_OTHER||LS mean difference|0.99|||<|0.001|TWO_SIDED|95.0|0.57|1.41|||Mixed Models Analysis|||Analysis via MMRM with fixed effects for baseline, baseline laxative response (LIR, non-LIR), treatment and treatment time interaction. Study pooled center is included as a random effect.||1.41|0.57|<0.001
72568614|NCT04168190|144668503|OTHER|Geometric mean titer (GMT) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMT Ratio|0.95|||||TWO_SIDED|95.0|0.59|1.54|||||Phase 1: V116 0.5 mL/Phase 1: Pneumovax™23|Serotype 19A||1.54|0.59|
72624386|NCT02507934|144778678|SUPERIORITY||Mean Difference (Final Values)|3.99||||0.1589|TWO_SIDED|95.0|-1.64|9.62||For each parameter, for each eye, an ANOVA model for repeated measures has been used by including each available timepoint. The estimated mean difference between treatments (Vismed-Lubricin) over time has been reported and tested.|repeated measures ANOVA|||Analysis of variance for repeated measures on Burning/ Stinging - Left eye||9.62|-1.64|0.1589
72490059|NCT01519765|144507789|SUPERIORITY_OR_OTHER|||||||0.4469|TWO_SIDED||||||Fisher Exact|||||||0.4469
72490060|NCT01519765|144507790|SUPERIORITY_OR_OTHER|||||||0.093|TWO_SIDED||||||Kruskal-Wallis|||||||0.093
72490061|NCT01519765|144507791|SUPERIORITY_OR_OTHER|||||||0.2417|TWO_SIDED||||||Fisher Exact|||||||0.2417
72490062|NCT01519765|144507792|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Fisher Exact|||||||1
72490063|NCT01519765|144507793|SUPERIORITY_OR_OTHER|||||||0.1054|TWO_SIDED||||||Fisher Exact|||||||0.1054
72624387|NCT02507934|144778678|SUPERIORITY||Mean Difference (Final Values)|2.78||||0.3167|TWO_SIDED|95.0|-2.78|8.35||For each parameter, for each eye, an ANOVA model for repeated measures has been used by including each available timepoint. The estimated mean difference between treatments (Vismed-Lubricin) over time has been reported and tested.|repeated measures ANOVA|||Analysis of variance for repeated measures on Burning/ Stinging - Right eye||8.35|-2.78|0.3167
72624388|NCT02507934|144778678|SUPERIORITY||Mean Difference (Final Values)|-1.84||||0.5243|TWO_SIDED|95.0|-7.64|3.96||For each parameter, for each eye, an ANOVA model for repeated measures has been used by including each available timepoint. The estimated mean difference between treatments (Vismed-Lubricin) over time has been reported and tested.|repeated measures ANOVA|||Analysis of variance for repeated measures on Itching - Left eye||3.96|-7.64|0.5243
72490064|NCT01519765|144507794|SUPERIORITY_OR_OTHER|||||||0.8043|TWO_SIDED||||||Fisher Exact|||||||0.8043
72490065|NCT01519765|144507795|SUPERIORITY_OR_OTHER|||||||0.797|TWO_SIDED||||||Fisher Exact|||||||0.797
72490066|NCT01519765|144507796|SUPERIORITY_OR_OTHER|||||||0.751|||||||Fisher Exact|||||||0.751
72490067|NCT01519765|144507797|SUPERIORITY_OR_OTHER|||||||0.6244|TWO_SIDED||||||Fisher Exact|||||||0.6244
72490068|NCT01519765|144507798|SUPERIORITY_OR_OTHER|||||||0.7906|TWO_SIDED||||||Fisher Exact|||||||0.7906
72490069|NCT01519765|144507799|SUPERIORITY_OR_OTHER|||||||0.5118|TWO_SIDED||||||Fisher Exact|||||||0.5118
72490070|NCT01519765|144507800|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Fisher Exact|||||||1
72490071|NCT01519765|144507801|SUPERIORITY_OR_OTHER|||||||0.741|TWO_SIDED||||||Fisher Exact|||||||0.741
72490072|NCT01519765|144507802|SUPERIORITY_OR_OTHER|||||||0.579|TWO_SIDED||||||Kruskal-Wallis|||||||0.579
72490073|NCT01519765|144507803|SUPERIORITY_OR_OTHER|||||||0.8062|||||||Kruskal-Wallis|||Score for Nausea and vomiting||||.8062
72490074|NCT01519765|144507803|SUPERIORITY_OR_OTHER|||||||0.1505|||||||Kruskal-Wallis|||Effectiveness||||0.1505
72490075|NCT01519765|144507803|SUPERIORITY_OR_OTHER|||||||0.1223|||||||Kruskal-Wallis|||Patient concern||||0.1223
72490076|NCT01519765|144507803|SUPERIORITY_OR_OTHER|||||||0.538||||||Patient satisfaction|Kruskal-Wallis|||Labor satisfaction||||0.5380
72490077|NCT01519765|144507804|SUPERIORITY_OR_OTHER|||||||0.2868||||||This is the overall p value of all rows.|Chi-squared|||||||0.2868
72490078|NCT01699542|144507805|SUPERIORITY|||||||0.159|||||||Generalized Linear Model|||||||0.159
72490079|NCT00432042|144507815|NON_INFERIORITY_OR_EQUIVALENCE|Measles difference|Mean Difference (Final Values)|1.14|||||TWO_SIDED|95.0|-1.62|4.82|||||Non-inferiority was declared when the lower bound of the two-sided 95% CI of the difference is \> -10%.|||4.82|-1.62|
72490080|NCT00432042|144507815|NON_INFERIORITY_OR_EQUIVALENCE|Mumps difference|Mean Difference (Final Values)|-1.83|||||TWO_SIDED|95.0|-4.21|1.1|||||Non-inferiority was declared when the lower bound of the two-sided 95% CI of the difference is \> -10%.|||1.10|-4.21|
72490081|NCT00432042|144507815|NON_INFERIORITY_OR_EQUIVALENCE|Rubella difference|Mean Difference (Final Values)|-1.2|||||TWO_SIDED|95.0|-3.19|1.35|||||Non-inferiority was declared when the lower bound of the two-sided 95% CI of the difference is \> -10%.|||1.35|-3.19|
72568615|NCT04168190|144668503|OTHER|Geometric mean titer (GMT) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMT Ratio|1.32|||||TWO_SIDED|95.0|0.81|2.15|||||Phase 1: V116 1.0 mL/Phase 1: Pneumovax™23|Serotype 19A||2.15|0.81|
72568616|NCT04168190|144668503|OTHER|Geometric mean titer (GMT) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMT Ratio|1.65|||||TWO_SIDED|95.0|0.85|3.23|||||Phase 1: V116 0.5 mL/Phase 1: Pneumovax™23|Serotype 22F||3.23|0.85|
72568617|NCT04168190|144668503|OTHER|Geometric mean titer (GMT) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMT Ratio|2.01|||||TWO_SIDED|95.0|1.03|3.96|||||Phase 1: V116 1.0 mL/Phase 1: Pneumovax™23|Serotype 22F||3.96|1.03|
72404442|NCT04164901|144315928|SUPERIORITY||Cox Proportional Hazard|0.39|||<|1e-07|TWO_SIDED|95.0|0.27|0.56|||Kaplan-Meier|||||0.56|0.27|<0.0000001
72404443|NCT04164901|144315931|SUPERIORITY||Odds Ratio (OR)|4.88||||0.003|TWO_SIDED|95.0|1.56|15.25|||Cochran-Mantel-Haenszel||Odds ratio was calculated with placebo as the control (denominator).|||15.25|1.56|0.003
72404444|NCT04164901|144315938|SUPERIORITY||Cox Proportional Hazard|0.35||||2.4e-07|TWO_SIDED|95.0|0.23|0.54|||Kaplan-Meier|||||0.54|0.23|0.00000024
72404445|NCT04998136|144315973|SUPERIORITY||Treatment difference|-12.99|||<|0.0001|TWO_SIDED|95.0|-15.28|-10.7|||ANCOVA|||Treatment policy Estimand. The primary endpoint was analysed using an analysis of covariance (ANCOVA) model with randomized treatment as factor and baseline body weight as covariate. Analysed data is from in-trial observation period.||-10.70|-15.28|<0.0001
72404446|NCT04998136|144315974|SUPERIORITY||Treatment Difference|-13.4|||<|0.0001|TWO_SIDED|95.0|-15.7|-11.11|||MMRM|||Hypothetical Estimand. The primary endpoint was analysed using mixed model for repeated measurements (MMRM). All responses prior to first discontinuation of treatment (or dose reduction, or initiation of other anti-obesity medication or bariatric surgery) were included in MMRM with randomized treatment as factor and baseline body weight as covariate. Analysed data is from on-treatment observation period.||-11.11|-15.70|<0.0001
72516444|NCT01309841|144563971|SUPERIORITY_OR_OTHER||LS mean difference|-0.08||||0.273|TWO_SIDED|95.0|-0.21|0.06||Analysis for change in PAC-SYM total score from baseline (Week 1) to end of treatment (Week 12)|Mixed Models Analysis|||Analysis via MMRM with fixed effects for baseline, baseline laxative response, treatment and treatment time interaction. Study pooled center is included as a random effect.||0.06|-0.21|0.273
72516445|NCT01309841|144563971|SUPERIORITY_OR_OTHER||LS mean difference|-0.12||||0.089|TWO_SIDED|95.0|-0.26|0.02||Analysis for change in PAC-SYM total score from baseline (Week 1) to end of treatment (Week 12)|Mixed Models Analysis|||Analysis via MMRM with fixed effects for baseline, baseline laxative response, treatment and treatment time interaction. Study pooled center is included as a random effect.||0.02|-0.26|0.089
72568618|NCT04168190|144668503|OTHER|Geometric mean titer (GMT) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMT Ratio|0.86|||||TWO_SIDED|95.0|0.44|1.67|||||Phase 1: V116 0.5 mL/Phase 1: Pneumovax™23|Serotype 33F||1.67|0.44|
72404447|NCT04998136|144315975|SUPERIORITY||Odds Ratio (OR)|88.87|||<|0.0001|TWO_SIDED|95.0|21.96|359.61|||Regression, Logistic|||Treatment policy estimand. The primary endpoint was analysed using a binary logistic regression model with randomized treatment as factor and baseline body weight as covariate. Analysed data is from in-trial period.||359.61|21.96|<0.0001
72404448|NCT04998136|144315976|SUPERIORITY||Odds Ratio (OR)|253.47|||<|0.0001|TWO_SIDED|95.0|38.41|1672.57|||Regression, Logistic|||Hypothetical estimand. MMRM was used with randomized treatment as factor and baseline body weight as covariate. The MMRM was performed on body weight (kg) and individual missing week 44 responses were predicted from the MMRM, each participant was then classified for body weight loss \>= 5% and analysed using a binary logistic regression model with randomized treatment as factor and baseline body weight as covariate. Analysed data is from on-treatment observation period.||1672.57|38.41|<0.0001
72404449|NCT01052545|144316093|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|||||Descriptive statistics were used to estimate the incidence rates per 1,000 bed-days and 95% confidence intervals (CI) for urine cultures ordered, ASB overtreatment and CAUTI under-treatment in each study period.|Regression, Logistic|to test whether there was a significant difference in monthly urine cultures ordered between the two study sites over time.||||||<0.05
72404450|NCT01052545|144316099|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|||||We used χ2 test, Fisher's exact test and one-way ANOVA to determine if patient-level covariates differed between the baseline, intervention and maintenance periods at each study site.|Regression, Logistic|||||||<0.05
72404451|NCT00453999|144316100|SUPERIORITY_OR_OTHER|||||||0.306|TWO_SIDED||||||Log Rank|Differences between groups by log-rank statistic stratified by oxygen saturation and duration of illness at randomization, and flu season.||||||0.306
72404452|NCT00453999|144316101|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Sore Throat: change from Baseline at Days 2, 3, 4, 5, 10, 14||||>0.05
72404453|NCT00453999|144316101|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Nasal Congestion: change from Baseline at Days 2, 3, 4, 5, 10, 14||||>0.05
72404454|NCT00453999|144316101|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Cough: change from Baseline at Days 2, 3, 4, 5, 10, 14||||>0.05
72404455|NCT00453999|144316101|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Aches and Pains: change from Baseline at Days 2, 3, 4, 5, 10, 14||||>0.05
72404456|NCT00453999|144316101|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Fatigue: change from Baseline at Days 2, 3, 4, 5, 10, 14||||>0.05
72404457|NCT00453999|144316101|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Headache: change from Baseline at Days 2, 3, 4, 5, 10, 14||||>0.05
72404458|NCT00453999|144316101|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Feeling Feverish: change from Baseline at Days 2, 3, 4, 5, 10, 14||||>0.05
72404459|NCT00453999|144316102|SUPERIORITY_OR_OTHER|||||||0.276|TWO_SIDED||||||Log Rank|||||||0.276
72404460|NCT00453999|144316104|SUPERIORITY_OR_OTHER|||||||0.994|TWO_SIDED||||||Log Rank|||||||0.994
72404461|NCT00453999|144316105|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Change from Baseline at 12 hours||||>0.05
72404462|NCT00453999|144316105|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Change from Baseline at 24 hours||||>0.05
72404463|NCT00453999|144316105|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Change from Baseline at 36 hours||||>0.05
72568619|NCT04168190|144668503|OTHER|Geometric mean titer (GMT) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMT Ratio|1.89|||||TWO_SIDED|95.0|0.97|3.69|||||Phase 1: V116 1.0 mL/Phase 1: Pneumovax™23|Serotype 33F||3.69|0.97|
72490082|NCT00432042|144507815|NON_INFERIORITY_OR_EQUIVALENCE|Varicella difference|Mean Difference (Final Values)|2.53|||||TWO_SIDED|95.0|-0.41|6.58|||||Non-inferiority was declared when the lower bound of the two-sided 95% CI of the difference is \> -10%.|||6.58|-0.41|
72516446|NCT01309841|144563971|SUPERIORITY_OR_OTHER||Slope|0.02||||0.849|TWO_SIDED|95.0|-0.14|0.17||Analysis for change in PAC-SYM abdominal symptoms subscore from baseline (Week 1) to end of treatment (Week 12)|Mixed Models Analysis|||Analysis via MMRM with fixed effects for baseline, baseline laxative response, treatment and treatment time interaction. Study pooled center is included as a random effect.||0.17|-0.14|0.849
72516447|NCT01309841|144563971|SUPERIORITY_OR_OTHER||LS mean difference|-0.03||||0.749|TWO_SIDED|95.0|-0.18|0.13||Analysis for change in PAC-SYM abdominal symptoms subscore from baseline (Week 1) to end of treatment (Week 12)|Mixed Models Analysis|||Analysis via MMRM with fixed effects for baseline, baseline laxative response, treatment and treatment time interaction. Study pooled center is included as a random effect.||0.13|-0.18|0.749
72490083|NCT00432042|144507816|NON_INFERIORITY_OR_EQUIVALENCE|Hepatitis B difference|Mean Difference (Final Values)|1.36|||||TWO_SIDED|95.0|-0.29|4.24|||||Non-inferiority was declared when the lower bound of the two-sided 95% CI of the difference is \> -5%.|||4.24|-0.29|
72490084|NCT00432042|144507816|NON_INFERIORITY_OR_EQUIVALENCE|Haemophilus Influenza type B difference|Mean Difference (Final Values)|2.97|||||TWO_SIDED|95.0|-0.17|6.89|||||Non-inferiority was declared when the lower bound of the two-sided 95% CI of the difference is \> -5%.|||6.89|-0.17|
72490085|NCT00432042|144507817|NON_INFERIORITY_OR_EQUIVALENCE|Anti-PT difference|GMT ratio|0.97|||||TWO_SIDED|95.0|0.88|1.08|||||Non-inferiority was declared when the lower bound of the two-sided 95% CI of the difference is \> -5%.|||1.08|0.88|
72490086|NCT00432042|144507817|NON_INFERIORITY_OR_EQUIVALENCE|Anti-FHA difference|GMT ratio|1.09|||||TWO_SIDED|95.0|0.98|1.23|||||Non-inferiority was declared when the lower bound of the two-sided 95% CI of the difference is \> -5%.|||1.23|0.98|
72490087|NCT00432042|144507817|NON_INFERIORITY_OR_EQUIVALENCE|Anti-PRN difference|GMT ratio|1.18|||||TWO_SIDED|95.0|1.03|1.36|||||Non-inferiority was declared when the lower bound of the two-sided 95% CI of the difference is \> -5%.|||1.36|1.03|
72490088|NCT01970501|144507823|SUPERIORITY||Hazard Ratio (HR)|1.02||||0.905|TWO_SIDED|95.0|0.72|1.45|||Log Rank|||||1.45|.72|0.905
72490089|NCT01970501|144507824|SUPERIORITY||Hazard Ratio (HR)|1.01||||0.961|TWO_SIDED|95.0|0.71|1.42|||Log Rank|||||1.42|0.71|0.961
72490090|NCT03924752|144507827|OTHER|A two-way repeated-measures analysis of variance (ANOVA) was performed on different walking conditions (including the baseline of not wearing the exoskeleton) on the subject's overground self-selected walking speed across different locomotion modes by setting the significant value to 0.05. Two independent variables were assistance type (Exo vs No Exo) and different locomotion modes.||||||0.9547||||||This presents the effect of exoskeleton assistance on the user's preferred overground walking speed across different locomotion modes.|ANOVA|||||||0.9547
72490091|NCT03803059|144507828|SUPERIORITY||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||Calculated using Wilcoxon signed rank test. Testing hypothesis is that the mean change from baseline is zero||||<0.01
72490092|NCT03803059|144507829|SUPERIORITY||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||Calculated using Wilcoxon signed rank test. Testing hypothesis is that the mean score is equal to 4 (no change).||||<0.01
72490093|NCT03803059|144507830|SUPERIORITY||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||Calculated using the Wilcoxon signed rank test. Testing hypothesis is that the mean score is equal to 4.||||<0.01
72490094|NCT03803059|144507831|SUPERIORITY|||||||0.051|||||||t-test, 1 sided|||Calculated using paired t-test. The testing hypothesis is that the mean change from baseline is zero.||||0.051
72490095|NCT03803059|144507832|SUPERIORITY||||||<|0.01|||||||t-test, 1 sided|||Calculated from paired t-test. The testing hypothesis is that the mean change from baseline is zero.||||<0.01
72490096|NCT03803059|144507833|SUPERIORITY|||||||0.331|||||||t-test, 1 sided|||Calculated from paired t-test. The testing hypothesis is that the mean change from baseline is zero.||||0.331
72490097|NCT03803059|144507834|SUPERIORITY|||||||0.863|||||||t-test, 2 sided|||Calculated using the paired t test. Testing hypothesis is that the mean change from baseline is zero.||||0.863
72490098|NCT03803059|144507835|SUPERIORITY|||||||0.048|||||||t-test, 2 sided|||Calculated using the paired t-test. The testing hypothesis is that the mean change from baseline is zero.||||0.048
72490099|NCT03803059|144507836|SUPERIORITY|||||||0.355||||||P-value reported is for viscoelastic deformation.|t-test, 2 sided|at significance level alpha+0.05||Calculated using the paired t-test. The testing hypothesis is that the mean change from baseline is zero.||||0.355
72490100|NCT03803059|144507837|SUPERIORITY|||||||0.859||||||Calculated with a paired T test. Testing hypothesis is that the mean change from baseline is zero.|t-test, 2 sided|||Calculated using the paired t test. Testing hypothesis is that the mean change from baseline is zero.||||0.859
72490101|NCT03803059|144507838|EQUIVALENCE|.A binomial (sign) test was performed to test if the the proportion of the combined designated favorable evaluations/responses is equal to the combined designated negative evaluations/responses for each question|||||<|0.01|||||||Sign test|||Patient satisfaction questionnaires were tabulated, and the frequency and percentage of all response options were reported for each question and time point calculated from the binomial (sign) test. The testing hypothesis is that the proportion of favorable responses is equal to the unfavorable||||<0.01
72490102|NCT03803059|144507839|SUPERIORITY|||||||0.031||||||All statistical tests were 2-sided at significance level alpha=0.05. No multiple testing corrections were considered in the study.|t-test, 2 sided|||The null hypothesis that the mean change from baseline is zero was tested using a paired t-test||||0.031
72490103|NCT04013529|144507842|SUPERIORITY||||||=|0.9|||||||ANCOVA|||||||=0.90
72490104|NCT04013529|144507843|SUPERIORITY||||||=|0.88|||||||ANCOVA|||||||= 0.88
72490105|NCT04013529|144507844|SUPERIORITY||||||<|0.17|||||||ANCOVA|||||||< 0.17
72490106|NCT04013529|144507845|SUPERIORITY||||||<|0.05|||||||ANCOVA|||||||< 0.05
72490107|NCT04013529|144507846|SUPERIORITY||||||=|0.81|||||||ANCOVA|||||||= 0.81
72404464|NCT00453999|144316105|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Change from Baseline at 48 hours||||>0.05
72404465|NCT00453999|144316105|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Change from Baseline at 72 hours||||>0.05
72516448|NCT01309841|144563971|SUPERIORITY_OR_OTHER||LS mean difference|-0.13||||0.062|TWO_SIDED|95.0|-0.26|0.01||Analysis for change in PAC-SYM rectal symptoms subscore from baseline (Week 1) to end of treatment (Week 12)|Mixed Models Analysis|||Analysis via MMRM with fixed effects for baseline, baseline laxative response, treatment and treatment time interaction. Study pooled center is included as a random effect.||0.01|-0.26|0.062
72516449|NCT01309841|144563971|SUPERIORITY_OR_OTHER||LS mean difference|-0.21||||0.003|TWO_SIDED|95.0|-0.35|-0.07||Analysis for change in PAC-SYM rectal symptoms subscore from baseline (Week 1) to end of treatment (Week 12)|Mixed Models Analysis|||Analysis via MMRM with fixed effects for baseline, baseline laxative response, treatment and treatment time interaction. Study pooled center is included as a random effect.||-0.07|-0.35|0.003
72516450|NCT01309841|144563971|SUPERIORITY_OR_OTHER||LS mean difference|-0.11||||0.202|TWO_SIDED|95.0|-0.29|0.06||Analysis for change in PAC-SYM stool symptoms subscore from baseline (Week 1) to end of treatment (Week 12)|Mixed Models Analysis|||Analysis via MMRM with fixed effects for baseline, baseline laxative response, treatment and treatment time interaction. Study pooled center is included as a random effect.||0.06|-0.29|0.202
72516451|NCT01309841|144563971|SUPERIORITY_OR_OTHER||LS mean difference|-0.16||||0.072|TWO_SIDED|95.0|-0.34|0.01||Analysis for change in PAC-SYM stool symptoms subscore from baseline (Week 1) to end of treatment (Week 12)|Mixed Models Analysis|||Analysis via MMRM with fixed effects for baseline, baseline laxative response, treatment and treatment time interaction. Study pooled center is included as a random effect.||0.01|-0.34|0.072
72516452|NCT01309841|144563972|SUPERIORITY_OR_OTHER||LS mean difference|-0.02||||0.831|TWO_SIDED|95.0|-0.25|0.2|||Mixed Models Analysis|||Analysis via MMRM with fixed effects for baseline, baseline laxative response, treatment and treatment time interaction. Due to convergence issues, study pooled center is also included as a fixed, rather than random effect.||0.20|-0.25|0.831
72516453|NCT01309841|144563972|SUPERIORITY_OR_OTHER||LS mean difference|-0.18||||0.141|TWO_SIDED|95.0|-0.41|0.06|||Mixed Models Analysis|||Analysis via MMRM with fixed effects for baseline, baseline laxative response, treatment and treatment time interaction. Due to convergence issues, study pooled center is also included as a fixed, rather than random effect.||0.06|-0.41|0.141
72516454|NCT00138424|144564000|SUPERIORITY_OR_OTHER||Spearman Correlation|0.24||||0.57|||||||Spearman Correlation|||Spearman correlation co-efficient utilized to determine viral load changes in plasma vs the PK Cmax parameter||||0.57
72516455|NCT00138424|144564000|SUPERIORITY_OR_OTHER||Spearman Correlation|0.26||||0.53|||||||Spearman Correlation|||Spearman correlation co-efficient utilized to determine viral load changes in urine vs the PK Cmax parameter||||0.53
72516456|NCT00138424|144564000|SUPERIORITY_OR_OTHER||Spearman Correlation|-0.3||||0.62|||||||Spearman Correlation|||Spearman correlation co-efficient utilized to determine viral load changes in plasma vs the PK Cmax parameter||||0.62
72516457|NCT00138424|144564000|SUPERIORITY_OR_OTHER||Spearman Correlation|0.8||||0.1|||||||Spearman Correlation|||Spearman correlation co-efficient utilized to determine viral load changes in urine vs the PK Cmax parameter||||0.10
72516458|NCT00138424|144564001|SUPERIORITY_OR_OTHER||Spearman Correlation|0.07||||0.87|||||||Spearman Correlation|||Spearman correlation co-efficient utilized to determine viral load changes in plasma vs the PK AUC4 parameter||||0.87
72516459|NCT00138424|144564001|SUPERIORITY_OR_OTHER||Spearman Correlation|0.31||||0.46|||||||Spearman Correlation|||Spearman correlation co-efficient utilized to determine viral load changes in urine vs the PK AUC4 parameter||||0.46
72516460|NCT00138424|144564001|SUPERIORITY_OR_OTHER||Spearman Correlation|-0.41||||0.49|||||||Spearman Correlation|||Spearman correlation co-efficient utilized to determine viral load changes in plasma vs the PK AUC4 parameter||||0.49
72516461|NCT00138424|144564001|SUPERIORITY_OR_OTHER||Spearman Correlation|0.87||||0.05|||||||Spearman Correlation|||Spearman correlation co-efficient utilized to determine viral load changes in urine vs the PK AUC4 parameter||||0.05
72404466|NCT00453999|144316105|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Change from Baseline at 96 hours||||>0.05
72404467|NCT00802412|144316107|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.6||||0.51|TWO_SIDED|95.0|0.4|6.5|||Regression, Logistic|||||6.5|0.4|0.51
72516462|NCT00138424|144564001|SUPERIORITY_OR_OTHER||Spearman Correlation|0.12||||0.78|||||||Spearman Correlation|||Spearman correlation co-efficient utilized to determine viral load changes in plasma vs the PK AUC12 parameter||||0.78
72516463|NCT00138424|144564001|SUPERIORITY_OR_OTHER||Spearman Correlation|0.52||||0.18|||||||Spearman Correlation|||Spearman correlation co-efficient utilized to determine viral load changes in urine vs the PK AUC12 parameter||||0.18
72404468|NCT00802412|144316107|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.3||||0.45|TWO_SIDED|95.0|0.66|2.55|||Regression, Cox|||||2.55|0.66|.45
72404469|NCT06049043|144316161|SUPERIORITY||Mean Difference (Final Values)|-5.09|STANDARD_ERROR_OF_MEAN|0.04||0.26|TWO_SIDED|95.0|-14.02|3.84|||t-test, 2 sided|||||3.84|-14.02|0.26
72516464|NCT00138424|144564001|SUPERIORITY_OR_OTHER||Spearman Correlation|0.2||||0.75|||||||Spearman Correlation|||Spearman correlation co-efficient utilized to determine viral load changes in plasma vs the PK AUC12 parameter||||0.75
72516465|NCT00138424|144564001|SUPERIORITY_OR_OTHER||Spearman Correlation|0.2||||0.75|||||||Spearman Correlation|||Spearman correlation co-efficient utilized to determine viral load changes in urine vs the PK AUC12 parameter||||0.75
72516466|NCT01056341|144564066|SUPERIORITY_OR_OTHER||||||<|0.0001||||||"P-value not adjusted for multiplicity. An Independent Committee conducted this analysis to determine the most efficacious of all arms with a good safety profile.~P-value linked to the 3 mg/kg/day 6 months selected arm ."|One-sided Z-tests|One-sided Z-tests for proportions (contrasts tests on placebo) with pooled variance||The interim analysis was carried out after the first 188 patients have completed their W24 visit or been withdrawn prematurely from study therapy. For each propranolol arm, individual hypotheses H0,i: θi≤0||||< 0.0001
72404470|NCT06049043|144316162|SUPERIORITY||Mean Difference (Final Values)|-0.04|STANDARD_ERROR_OF_MEAN|4.84||0.44|TWO_SIDED|95.0|-13.43|5.85|||t-test, 2 sided|||||5.85|-13.43|0.44
72404471|NCT06049043|144316163|SUPERIORITY||Mean Difference (Final Values)|0.22|STANDARD_ERROR_OF_MEAN|0.44||0.62|TWO_SIDED|95.0|-0.66|1.1|||t-test, 2 sided|||||1.10|-0.66|0.62
72404472|NCT06049043|144316164|SUPERIORITY||Mean Difference (Final Values)|6.34|STANDARD_ERROR_OF_MEAN|0.04||0.16|TWO_SIDED|95.0|-2.5|15.18|||t-test, 2 sided|||||15.18|-2.50|0.16
72404473|NCT06049043|144316164|SUPERIORITY||Slope|-0.05|STANDARD_ERROR_OF_MEAN|0.04||0.28|TWO_SIDED|95.0|-0.13|0.04|||Regression, Linear|Controlled for participant characteristics at baseline.||||0.04|-0.13|0.28
72404474|NCT06049043|144316165|SUPERIORITY||Mean Difference (Final Values)|1.98|STANDARD_ERROR_OF_MEAN|4.67||0.67|TWO_SIDED|95.0|-7.31|11.28|||t-test, 2 sided|||||11.28|-7.31|0.67
72404475|NCT06049043|144316165|SUPERIORITY||Slope|-0.02|STANDARD_ERROR_OF_MEAN|0.05||0.69|TWO_SIDED|95.0|-0.12|0.08|||Regression, Linear|Controlled for participant characteristics at baseline.||||0.08|-0.12|0.69
72404476|NCT06049043|144316166|SUPERIORITY||Mean Difference (Final Values)|0.55|STANDARD_ERROR_OF_MEAN|0.32||0.09|TWO_SIDED|95.0|-0.09|1.18|||t-test, 2 sided|||||1.18|-0.09|0.09
72490108|NCT02116777|144507864|OTHER|Maximum Tolerate Dose Level was determined by the rolling-6 design.|Maximum Tolerate Dose Level|4.0|||||TWO_SIDED||||||||Maximum Tolerate Dose Level is Dose Level 4 (600 mcg/m²/dose +30 mg/m2/dose (BMN 673) BID + 30 mg/m²/dose (TEM), Max 1000 mcg/day). MTD determined by using the Rolling-6 Design.|||||
72568620|NCT04168190|144668503|OTHER|Geometric mean titer (GMT) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMT Ratio|0.7|||||TWO_SIDED|95.0|0.46|1.08|||||Phase 1: V116 0.5 mL/Phase 1: Pneumovax™23|Serotype 8||1.08|0.46|
72404477|NCT06049043|144316166|SUPERIORITY||Slope|-0.13|STANDARD_ERROR_OF_MEAN|0.36||0.71|TWO_SIDED|95.0|-0.86|0.59|||Regression, Linear|Controlled for participant characteristics at baseline.||||0.59|-0.86|0.71
72404478|NCT06049043|144316167|SUPERIORITY||Mean Difference (Final Values)|0.6|STANDARD_ERROR_OF_MEAN|0.34||0.08|TWO_SIDED|95.0|-0.07|1.27|||t-test, 2 sided|||||1.27|-0.07|0.08
72404479|NCT06049043|144316167|SUPERIORITY||Slope|-0.36|STANDARD_ERROR_OF_MEAN|0.42||0.39|TWO_SIDED|95.0|-1.21|0.48|||Regression, Linear|Controlled for participant characteristics at baseline.||||0.48|-1.21|0.39
72404480|NCT06049043|144316169|SUPERIORITY||Mean Difference (Final Values)|-0.06|STANDARD_ERROR_OF_MEAN|0.22||0.89|TWO_SIDED|95.0|-0.95|0.82|||t-test, 2 sided|||||0.82|-0.95|0.89
72404481|NCT01354496|144316174|SUPERIORITY_OR_OTHER||Ratio of geometric least squares means|1.03|||||TWO_SIDED|90.0|0.897|1.18|||||AUC0-∞ was log-transformed and analyzed using a linear mixed effects model with fixed factors for formulation, sequence, and period, and random factor for participant.|||1.18|0.897|
72404482|NCT01354496|144316175|SUPERIORITY_OR_OTHER||Ratio of geometric least squares means|1.06|||||TWO_SIDED|90.0|0.922|1.22|||||Cmax was log-transformed and analyzed using a linear mixed effects model with fixed factors for formulation, sequence, and period, and random factor for participant.|||1.22|0.922|
72404483|NCT01354496|144316176|SUPERIORITY_OR_OTHER||Ratio of geometric least squares means|1.02|||||TWO_SIDED|90.0|0.896|1.16|||||AUC0-∞ was log-transformed and analyzed using a linear mixed effects model with fixed factors for formulation, sequence, and period, and random factor for participant.|||1.16|0.896|
72490109|NCT01733628|144507883|OTHER|Type of statistical Test: Inequality|Hazard Ratio (HR)|0.94||||0.8166|TWO_SIDED|95.0|0.56|1.59|||Wilcoxon (Mann-Whitney)|||||1.59|0.56|0.8166
72404484|NCT01354496|144316177|SUPERIORITY_OR_OTHER||Ratio of geometric least squares means|1.01|||||TWO_SIDED|90.0|0.882|1.15|||||Cmax was log-transformed and analyzed using a linear mixed effects model with fixed factors for formulation, sequence, and period, and random factor for participant.|||1.15|0.882|
72404485|NCT01354496|144316179|SUPERIORITY_OR_OTHER||Ratio of geometric least squares means|0.993|||||TWO_SIDED|90.0|0.951|1.04|||||AUC0-∞ was log-transformed and analyzed using a linear mixed effects model with fixed factors for formulation, sequence, and period, and random factor for participant.|||1.04|0.951|
72404486|NCT01354496|144316179|SUPERIORITY_OR_OTHER||Ratio of geometric least squares means|0.943|||||TWO_SIDED|90.0|0.905|0.983|||||AUC0-∞ was log-transformed and analyzed using a linear mixed effects model with fixed factors for formulation, sequence, and period, and random factor for participant.|||0.983|0.905|
72404487|NCT01354496|144316180|SUPERIORITY_OR_OTHER||Ratio of geometric least squares means|0.98|||||TWO_SIDED|90.0|0.926|1.04|||||Cmax was log-transformed and analyzed using a linear mixed effects model with fixed factors for formulation, sequence, and period, and random factor for participant.|||1.04|0.926|
72404488|NCT01354496|144316180|SUPERIORITY_OR_OTHER||Ratio of geometric least squares means|0.94|||||TWO_SIDED|90.0|0.891|0.993|||||Cmax was log-transformed and analyzed using a linear mixed effects model with fixed factors for formulation, sequence, and period, and random factor for participant.|||0.993|0.891|
72404489|NCT01228747|144316181|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-56.13|STANDARD_ERROR_OF_MEAN|6.15|<|0.0001|TWO_SIDED|95.0|-68.24|-44.02||Statistical testing was 2-sided, and was performed using a significance (α) level of 0.05.|ANCOVA|||"The statistical hypotheses, null hypothesis (H0) and alternate hypothesis (H1), are stated below:~H0: μLEV = μPBO vs. H1: μLEV ≠ μPBO~ANCOVA on the endpoint percentage change from Combined Baseline of GTC seizures per week using treatment and country as factors (categorical predictors) and Combined Baseline GTC seizure frequency per week as a covariate (a continuous predictor) where μLEV and μPBO are adjusted means for LEV and PBO, respectively."||-44.02|-68.24|<0.0001
72490110|NCT00980200|144507892|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.094|||<|0.001|TWO_SIDED|95.0|0.049|0.14|||ANCOVA|||||0.140|0.049|<0.001
72490111|NCT00980200|144507892|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.14|||<|0.001|TWO_SIDED|95.0|0.095|0.185|||ANCOVA|||||0.185|0.095|<0.001
72490112|NCT00980200|144507892|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.102|||<|0.001|TWO_SIDED|95.0|0.057|0.147|||ANCOVA|||||0.147|0.057|<0.001
72490113|NCT00980200|144507892|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.125|||<|0.001|TWO_SIDED|95.0|0.08|0.17|||ANCOVA|||||0.170|0.080|<0.001
72490114|NCT00457015|144507894|SUPERIORITY_OR_OTHER_LEGACY|||||||0.01||95.0||||No adjustment was made for multiple comparisons. Treatment effect will be deemed statistically significant if the coefficient for the treatment group within the statistical model is significant at level 0.05.|Blocked Wilcoxon rank sum test|||The primary efficacy analysis compared the change from baseline in MSCS Score at 4 hours post-dosing for patients treated with ecallantide and placebo. Treatment effect was assessed by the nonparametric Blocked Wilcoxon Rank Sum test because of an assumed non-normal distribution.||||0.010
72624389|NCT02507934|144778678|SUPERIORITY||Mean Difference (Final Values)|1.19||||0.6714|TWO_SIDED|95.0|-4.45|6.82||For each parameter, for each eye, an ANOVA model for repeated measures has been used by including each available timepoint. The estimated mean difference between treatments (Vismed-Lubricin) over time has been reported and tested.|repeated measures ANOVA|||Analysis of variance for repeated measures on Itching - Right eye||6.82|-4.45|0.6714
72624390|NCT02507934|144778678|SUPERIORITY||Mean Difference (Final Values)|-3.89||||0.0828|TWO_SIDED|95.0|-8.31|0.53||For each parameter, for each eye, an ANOVA model for repeated measures has been used by including each available timepoint. The estimated mean difference between treatments (Vismed-Lubricin) over time has been reported and tested.|repeated measures ANOVA|||Analysis of variance for repeated measures on Pain - Left eye||0.53|-8.31|0.0828
72404490|NCT00811577|144316212|SUPERIORITY_OR_OTHER|||||||0.57|TWO_SIDED|95.0||||For this early phase study, multiple comparisons adjustments were not used.|Wilcoxon (signed rank)|||Using serial gate-keeping to preserve the 5% overall type I error of 1-4 two-sided tests, 2-sided Wilcoxon Signed Rank tests were used. Computer graphics were used to display outcomes at Month 12, compare paired differences of outcomes between the 2 dosages and placebo, and show time trends in mean outcomes. Repeated measures regression models (GEE models in SAS/STAT PROC GENMOD) were used to examine longitudinal outcomes with terms for treatment and trocar location adjusted for key covariates.||||0.57
72516467|NCT01056341|144564067|SUPERIORITY_OR_OTHER||||||<|0.0001||||||The methodology used guaranteed that the familywise type I error rate was below the nominal one-sided significance level of 0.005.|combination tests|Superiority was tested using the closed testing procedure and combination tests for all intersection hypotheses using Simes' adjustment.||"The objective is to test the superiority of the selected arm using the approach of Posch et al.~The primary analysis was performed on the intent-to-treat population: all treated patients in Stage 1 and all treated patients in stage 2 randomized to placebo or the selected arm."||||< 0.0001
72516468|NCT01167582|144564071|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||Day 1 Post Randomization||||<0.001
72516469|NCT01167582|144564071|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||Day 2 Post Randomization||||<0.001
72516470|NCT01167582|144564071|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||Day 3 Post Randomization||||<0.001
72516471|NCT01167582|144564072|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
72516472|NCT01167582|144564073|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|2.38|||||TWO_SIDED|95.0|0.99|5.73|||||Restrictive Arm (numerator) compared to Liberal Arm (denominator)|||5.73|0.99|
72516473|NCT01167582|144564074|SUPERIORITY_OR_OTHER||Risk Difference (RD)|9.7||||||95.0|-5.3|24.7|||||Restrictive Arm (numerator) compared to Liberal Arm (denominator)|||24.7|-5.3|
72516474|NCT01167582|144564075|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|7.13|||||TWO_SIDED|95.0|0.91|56.02|||||Restrictive Arm (numerator) compared to Liberal Arm (denominator)|Mortality||56.02|0.91|
72516475|NCT01167582|144564075|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.43|||||TWO_SIDED|95.0|0.48|4.22|||||Restrictive Arm (numerator) compared to Liberal Arm (denominator)|Myocardial Infarction||4.22|0.48|
72516476|NCT01583452|144564084|SUPERIORITY_OR_OTHER|||||||0.665|TWO_SIDED||||||Kaplan-Meier survival analysis|||With a confidence interval of 95%, an alpha risk of 5% and a desired power of 80%; expecting a 24hrs difference between the intervention and the control group, we estimated 20 patients for each one of them.||||0.665
72516477|NCT01583452|144564085|SUPERIORITY_OR_OTHER|||||||0.094|TWO_SIDED||||||Kaplan-Meier survival analysis|||||||0.094
72516478|NCT01583452|144564086|SUPERIORITY_OR_OTHER|||||||0.059|TWO_SIDED||||||Kaplan-Meier survival analysis|||||||0.059
72516479|NCT01583452|144564087|SUPERIORITY_OR_OTHER|||||||0.83|TWO_SIDED||||||Kaplan-Meier survival analysis|||||||0.830
72516480|NCT03103906|144564100|OTHER||Difference in proportion|2.56||||0.3334|TWO_SIDED|95.0|-19.99|25.07|||Chi-squared|||||25.07|-19.99|0.3334
72624391|NCT02507934|144778678|SUPERIORITY||Mean Difference (Final Values)|-0.58||||0.7823|TWO_SIDED|95.0|-4.77|3.62||For each parameter, for each eye, an ANOVA model for repeated measures has been used by including each available timepoint. The estimated mean difference between treatments (Vismed-Lubricin) over time has been reported and tested.|repeated measures ANOVA|||Analysis of variance for repeated measures on Pain - Right eye||3.62|-4.77|0.7823
72516481|NCT03571256|144564108|OTHER||LS mean difference|-0.8||||0.6|TWO_SIDED|95.0|-3.9|2.3||Threshold for significance at 0.05 level.|Mixed Models Analysis|||||2.3|-3.9|0.600
72516482|NCT00868452|144564119|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.6|STANDARD_ERROR_OF_MEAN|1.25||0.005|||||||Mixed Models Analysis|||||||0.005
72516483|NCT00868452|144564120|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.44|STANDARD_ERROR_OF_MEAN|0.15||0.003|||||||Mixed Models Analysis|||||||0.003
72516484|NCT00868452|144564121|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.6|STANDARD_ERROR_OF_MEAN|1.01||0.012|||||||ANCOVA|||||||0.012
72516485|NCT00643604|144564139|SUPERIORITY_OR_OTHER_LEGACY|||||||0.69||0.0|||||Wilcoxon signed-rank test|||Changes between Baseline and Week 8 were assessed using the Wilcoxon signed rank test. A two-sided p value of \< 0.05 was considered statistically significant. No imputation was used for missing values.||||0.69
72516486|NCT00643604|144564140|SUPERIORITY_OR_OTHER_LEGACY|||||||1||95.0|||||Wilcoxon signed-rank test|||Changes between Baseline and Week 8 were assessed using the Wilcoxon signed rank test. A two-sided p value of \< 0.05 was considered statistically significant. No imputation was used for missing values.||||1.00
72516487|NCT00643604|144564141|SUPERIORITY_OR_OTHER_LEGACY|||||||0.13||95.0|||||Wilcoxon signed-rank test|||Changes between Baseline and Week 8 were assessed using the Wilcoxon signed rank test. A two-sided p value of \< 0.05 was considered statistically significant. No imputation was used for missing values.||||0.13
72516488|NCT00643604|144564142|SUPERIORITY_OR_OTHER_LEGACY|||||||0.03||95.0||||p value for Symptom Score|Wilcoxon signed rank test|||Changes in mean CAMPHOR scores between Baseline and Week 8 were assessed using the Wilcoxon signed rank test. A two-sided p value of \< 0.05 was considered statistically significant. No imputation was used for missing values.||||0.03
72516489|NCT00643604|144564142|SUPERIORITY_OR_OTHER_LEGACY|||||||1||95.0||||p value for Activity Score.|Wilcoxon signed rank test|||Activity Score N=5; Baseline component score could not be calculated for one subject. Changes between Baseline and Week 8 were assessed using the Wilcoxon signed rank test. A two-sided p value of \< 0.05 was considered statistically significant. No imputation was used for missing values.||||1.00
72490115|NCT00457015|144507895|SUPERIORITY_OR_OTHER_LEGACY|||||||0.003||95.0||||No adjustment was made for multiple comparisons. Treatment effect will be deemed statistically significant if the coefficient for the treatment group within the statistical model is significant at level 0.05.|Blocked Wilcoxon rank sum test|||The analysis compared the TOS at 4 hours post-dosing for patients treated with ecallantide and placebo. Treatment effect was assessed by the nonparametric Blocked Wilcoxon Rank Sum test because of an assumed non-normal distribution.||||0.003
72490116|NCT00457015|144507896|SUPERIORITY_OR_OTHER_LEGACY|||||||0.102||95.0||||No adjustment was made for multiple comparisons. Treatment effect will be deemed statistically significant if the coefficient for the treatment group within the statistical model is significant at level 0.05.|Log Rank|||Kaplan-Meier analysis using the Log-Rank test was used to compare the time distribution between the 2 treatment groups.||||0.102
72490117|NCT02257372|144507979|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.123|||<|0.001|TWO_SIDED|95.0|0.071|0.174|||Mixed model repeated measures analysis|||||0.174|0.071|<0.001
72490118|NCT02257372|144507980|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.148|||<|0.001|TWO_SIDED|95.0|0.099|0.197|||Mixed model repeated measures analysis|||||0.197|0.099|<0.001
72490119|NCT04673292|144507996|EQUIVALENCE|The fixed site SOC testing study arm was the standard of care and reference group. The null hypothesis was that there is not a statistically significant difference in the proportion of participants who complete PCR COVID-19 testing within 30 days of randomization when comparing community-based testing to the fixed site SOC testing.|Prevalence Ratio|1.04||||0.67|TWO_SIDED|95.0|0.86|1.27|||Poisson Regression|Adjusted poisson regression was performed using Study Arm as a nominal variable in the model with the Fixed Site SOC Testing as the reference group.|||Models were adjusted for employment.|1.27|0.86|0.67
72490120|NCT04673292|144507996|EQUIVALENCE|The fixed site SOC testing study arm was the standard of care and reference group. The null hypothesis was that there is not a statistically significant difference in the proportion of participants who complete PCR COVID-19 testing within 30 days of randomization when comparing self-collected testing to the fixed site SOC testing.|Prevalence Ratio|1.08||||0.43|TWO_SIDED|95.0|0.89|1.31|||Poisson Regression|Adjusted poisson regression was performed using Study Arm as a nominal variable in the model with the Fixed Site SOC Testing as the reference group.|||Models were adjusted for employment.|1.31|0.89|0.43
72490121|NCT04673292|144507997|EQUIVALENCE|Testing for equivalence in the difference in time from randomization to completion of SARS-CoV-2 PCR testing when comparing the community-based testing to fixed site SOC testing. Alpha threshold of 0.05.|Time Ratio|0.87||||0.14|TWO_SIDED|95.0|0.73|1.05||aprior significance threshold: p-value\<0.05|Accelerated Failure Time|Study Arm included as a nominal (dummy) variable in accelerated failure time models. Models adjusted for employment.||Times were censored at 30 days.|Models adjusted for employment|1.05|0.73|0.14
72490122|NCT04673292|144507997|EQUIVALENCE|Testing for equivalence in the difference in time from randomization to completion of SARS-CoV-2 PCR testing when comparing the self-collected testing arm to the fixed site SOC testing Alpha threshold of 0.05.|Time Ratio|0.86||||0.09|TWO_SIDED|95.0|0.71|1.03||aprior significance threshold: p-value\<0.05|Accelerated Failure Time|Study Arm included as a nominal (dummy) variable in accelerated failure time models. Models adjusted for employment.||Times were censored at 30 days.|Models adjusted for employment|1.03|0.71|0.09
72490123|NCT04673292|144507998|EQUIVALENCE|Null hypothesis: There is no significant difference in time from completion of SARS-CoV-2 test to receipt of SARS-CoV-2 test results when comparing the community-based testing to fixed site SOC testing.|Time Ratio|0.96||||0.56|TWO_SIDED|95.0|0.83|1.1||aprior threshold for significance: p\<0.05|Accelerated Failure Time|Study arm included as a nominal (dummy) variable in accelerated failure time models. Models adjusted for employment.||Times were censored at 10 days.|Models adjusted for employment|1.10|0.83|0.56
72516490|NCT00643604|144564142|SUPERIORITY_OR_OTHER_LEGACY|||||||0.31||95.0|||||Wilcoxon signed-rank test|||Quality of Life Score. Changes between Baseline and Week 8 were assessed using the Wilcoxon signed rank test. A two-sided p value of \< 0.05 was considered statistically significant. No imputation was used for missing values.||||0.31
72516491|NCT00643604|144564142|SUPERIORITY_OR_OTHER_LEGACY|||||||0.13||95.0|||||Wilcoxon signed-rank test|||"Total Score N=5; Baseline Activity component score could not be calculated for one subject. Total Score could not be calculated for this subject.~Wilcoxon signed rank test was used to compare the values at Baseline to values at Week 8. A two-sided p value of \< 0.05 was considered statistically significant. No imputation was used for missing values."||||0.13
72516492|NCT00643604|144564143|SUPERIORITY_OR_OTHER_LEGACY|||||||0.19||95.0|||||Wilcoxon signed-rank test|||Effectiveness Score Changes between Baseline and Week 8 were assessed using the Wilcoxon signed rank test. A two-sided p value of \< 0.05 was considered statistically significant. No imputation was used for missing values.||||0.19
72490124|NCT04673292|144507998|EQUIVALENCE|Null hypothesis: There is no significant difference in time from completion of SARS-CoV-2 test to receipt of SARS-CoV-2 test results when comparing the self-collected testing arm to the fixed site SOC testing.|Time Ratio|0.93||||0.32|TWO_SIDED|95.0|0.81|1.07||aprior significance threshold: p-value\<0.05|Accelerated Failure Time|Study Arm included as a nominal (dummy) variable in accelerated failure time models. Models adjusted for employment.||Times were censored at 10 days.|Models adjusted for employment|1.07|0.81|0.32
72490125|NCT01761084|144508017|SUPERIORITY||Odds Ratio (OR)|1.06|||||TWO_SIDED|95.0|0.58|1.94||||||||1.94|.58|
72490126|NCT01761084|144508018|SUPERIORITY||Risk Ratio (RR)|1.32|||||TWO_SIDED|95.0|0.99|1.74||||||||1.74|.99|
72490127|NCT01761084|144508019|SUPERIORITY||Mean Difference (Final Values)|0.12||||0.811|TWO_SIDED|95.0|-0.84|1.07|||t-test, 2 sided|Intention-to-treat analysis|Intention-to-treat analysis|Baseline||1.07|-0.84|0.811
72490128|NCT01761084|144508019|SUPERIORITY||Mean Difference (Final Values)|0.14||||0.765|TWO_SIDED|95.0|-0.8|1.09|||t-test, 2 sided||Per-protocol analysis|Month 12||1.09|-0.80|0.765
72490129|NCT01761084|144508020|SUPERIORITY||Mean Difference (Final Values)|-0.09||||0.796|TWO_SIDED|95.0|-0.8|0.61|||t-test, 2 sided||Intention-to-treat analysis|Baseline||0.61|-0.80|0.796
72568621|NCT04168190|144668503|OTHER|Geometric mean titer (GMT) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMT Ratio|0.89|||||TWO_SIDED|95.0|0.58|1.38|||||Phase 1: V116 1.0 mL/Phase 1: Pneumovax™23|Serotype 8||1.38|0.58|
72568622|NCT04168190|144668503|OTHER|Geometric mean titer (GMT) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMT Ratio|1.15|||||TWO_SIDED|95.0|0.62|2.15|||||Phase 1: V116 0.5 mL/Phase 1: Pneumovax™23|Serotype 9N||2.15|0.62|
72568623|NCT04168190|144668503|OTHER|Geometric mean titer (GMT) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMT Ratio|1.09|||||TWO_SIDED|95.0|0.58|2.04|||||Phase 1: V116 1.0 mL/Phase 1: Pneumovax™23|Serotype 9N||2.04|0.58|
72568624|NCT04168190|144668503|OTHER|Geometric mean titer (GMT) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMT Ratio|1.56|||||TWO_SIDED|95.0|0.9|2.71|||||Phase 1: V116 0.5 mL/Phase 1: Pneumovax™23|Serotype 10A||2.71|0.90|
72568625|NCT04168190|144668503|OTHER|Geometric mean titer (GMT) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMT Ratio|1.87|||||TWO_SIDED|95.0|1.08|3.23|||||Phase 1: V116 1.0 mL/Phase 1: Pneumovax™23|Serotype 10A||3.23|1.08|
72568626|NCT04168190|144668503|OTHER|Geometric mean titer (GMT) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMT Ratio|0.89|||||TWO_SIDED|95.0|0.53|1.49|||||Phase 1: V116 0.5 mL/Phase 1: Pneumovax™23|Serotype 11A||1.49|0.53|
72568627|NCT04168190|144668503|OTHER|Geometric mean titer (GMT) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMT Ratio|1.11|||||TWO_SIDED|95.0|0.66|1.87|||||Phase 1: V116 1.0 mL/Phase 1: Pneumovax™23|Serotype 11A||1.87|0.66|
72490130|NCT01761084|144508020|SUPERIORITY||Mean Difference (Final Values)|-0.05||||0.888|TWO_SIDED|95.0|-0.75|0.65|||t-test, 2 sided||Per-protocol analysis|Month 12||0.65|-0.75|0.888
72490131|NCT01761084|144508021|SUPERIORITY||Mean Difference (Final Values)|0.12||||0.719|TWO_SIDED|95.0|-0.54|0.78|||t-test, 2 sided||Intention-to-treat analysis|Baseline||0.78|-0.54|0.719
72490132|NCT01761084|144508021|SUPERIORITY||Mean Difference (Final Values)|0.11||||0.745|TWO_SIDED|95.0|-0.56|0.79|||t-test, 2 sided||Per-protocol analysis|Month 12||0.79|-0.56|0.745
72490133|NCT01761084|144508022|SUPERIORITY||Mean Difference (Final Values)|0.59||||0.854|TWO_SIDED|95.0|-5.66|6.83|||t-test, 2 sided||Intention-to-treat analysis|Comparison of change from baseline in EQ5D - VAS||6.83|-5.66|0.854
72490134|NCT01761084|144508022|SUPERIORITY||Mean Difference (Final Values)|1.78||||0.585|TWO_SIDED|95.0|-4.66|8.22|||t-test, 2 sided||Per-protocol analysis|Comparison of change from baseline in EQ5D-VAS||8.22|-4.66|0.585
72490135|NCT01761084|144508022|SUPERIORITY||Mean Difference (Final Values)|0.16||||0.335|TWO_SIDED|95.0|-0.16|0.47|||t-test, 2 sided||Intention-to-treat analysis|Comparison of change from baseline in OQLQ Average Score||0.47|-0.16|0.335
72490136|NCT01761084|144508022|SUPERIORITY||Mean Difference (Final Values)|0.18||||0.285|TWO_SIDED|95.0|-0.15|0.5|||t-test, 2 sided||Per-protocol analysis|Comparison of change from baseline in OQLQ Average Score||0.50|-0.15|0.285
72490137|NCT01761084|144508022|SUPERIORITY||Mean Difference (Final Values)|-0.52||||0.225|TWO_SIDED|95.0|-1.36|0.32|||t-test, 2 sided||Intention-to-treat analysis|Comparison of change from baseline in pain VAS at rest||0.32|-1.36|0.225
72490138|NCT01761084|144508022|SUPERIORITY||Mean Difference (Final Values)|-0.3||||0.488|TWO_SIDED|95.0|-1.16|0.56|||t-test, 2 sided||Per-protocol analysis|Comparison of change from baseline in pain VAS at rest||0.56|-1.16|0.488
72568628|NCT04168190|144668503|OTHER|Geometric mean titer (GMT) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMT Ratio|1.7|||||TWO_SIDED|95.0|0.89|3.27|||||Phase 1: V116 0.5 mL/Phase 1: Pneumovax™23|Serotype 12F||3.27|0.89|
72568629|NCT04168190|144668503|OTHER|Geometric mean titer (GMT) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMT Ratio|2.4|||||TWO_SIDED|95.0|1.24|4.62|||||Phase 1: V116 1.0 mL/Phase 1: Pneumovax™23|Serotype 12F||4.62|1.24|
72568630|NCT04168190|144668503|OTHER|Geometric mean titer (GMT) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMT Ratio|1.97|||||TWO_SIDED|95.0|1.16|3.34|||||Phase 1: V116 0.5 mL/Phase 1: Pneumovax™23|Serotype 17F||3.34|1.16|
72568631|NCT04168190|144668503|OTHER|Geometric mean titer (GMT) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMT Ratio|2.06|||||TWO_SIDED|95.0|1.21|3.51|||||Phase 1: V116 1.0 mL/Phase 1: Pneumovax™23|Serotype 17F||3.51|1.21|
72568632|NCT04168190|144668503|OTHER|Geometric mean titer (GMT) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMT Ratio|1.22|||||TWO_SIDED|95.0|0.77|1.91|||||Phase 1: V116 0.5 mL/Phase 1: Pneumovax™23|Serotype 20A||1.91|0.77|
72568633|NCT04168190|144668503|OTHER|Geometric mean titer (GMT) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMT Ratio|1.56|||||TWO_SIDED|95.0|0.99|2.45|||||Phase 1: V116 1.0 mL/Phase 1: Pneumovax™23|Serotype 20A||2.45|0.99|
72568634|NCT04168190|144668504|OTHER|Geometric mean titer (GMT) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMT Ratio|13.98|||||TWO_SIDED|95.0|5.9|33.1|||||Phase 1: V116 0.5 mL/Phase 1: Pneumovax™23|Serotype 6A||33.10|5.90|
72568635|NCT04168190|144668504|OTHER|Geometric mean titer (GMT) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMT Ratio|14.42|||||TWO_SIDED|95.0|6.05|34.35|||||Phase 1: V116 1.0 mL/Phase 1: Pneumovax™23|Serotype 6A||34.35|6.05|
72568636|NCT04168190|144668504|OTHER|Geometric mean titer (GMT) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMT Ratio|7.39||||||95.0|4.29|12.75|||||Phase 1: V116 0.5 mL/Phase 1: Pneumovax™23|Serotype 15A||12.75|4.29|
72568637|NCT04168190|144668504|OTHER|Geometric mean titer (GMT) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMT Ratio|9.4|||||TWO_SIDED|95.0|5.42|16.28|||||Phase 1: V116 1.0 mL/Phase 1: Pneumovax™23|Serotype 15A||16.28|5.42|
72490139|NCT01761084|144508022|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.808|TWO_SIDED|95.0|-0.68|0.88|||t-test, 2 sided||Intention-to-treat analysis|Comparison of change from baseline in pain VAS during movement||0.88|-0.68|0.808
72490140|NCT01761084|144508022|SUPERIORITY||Mean Difference (Final Values)|0.23||||0.566|TWO_SIDED|95.0|-0.57|1.04|||t-test, 2 sided||Per-protocol analysis|Comparison of change from baseline in pain VAS during movement||1.04|-0.57|0.566
72490141|NCT01761084|144508025|SUPERIORITY||Mean Difference (Final Values)|0.045||||0.951|TWO_SIDED|95.0|-1.412|1.501|||t-test, 2 sided|||Baseline||1.501|-1.412|.951
72490142|NCT01761084|144508025|SUPERIORITY||Mean Difference (Final Values)|-1.396||||0.039|TWO_SIDED|95.0|-2.721|-0.071|||t-test, 2 sided|||Month 12||-0.071|-2.721|0.039
72490143|NCT01761084|144508026|SUPERIORITY||Mean Difference (Final Values)|-65.9|||<|0.05|TWO_SIDED|95.0|-91.8|-40.0||Month 6 strength and balance physical activity|t-test, 2 sided|||Only Month 6 and Month 12 strength and balance physical activity differences were significant.||-40.0|-91.8|<0.05
72490144|NCT01761084|144508026|SUPERIORITY||Mean Difference (Final Values)|-49.3|||<|0.05|TWO_SIDED|95.0|-69.8|-28.8||Month 12 strength and balance physical activity|t-test, 2 sided|||Only Month 6 and Month 12 strength and balance physical activity differences were significant.||-28.8|-69.8|<0.05
72490145|NCT01761084|144508031|SUPERIORITY||Incident Rate Ratio|0.97|||||TWO_SIDED|95.0|0.58|1.63||||||Negative Binomial Regression.||1.63|.58|
72490146|NCT01761084|144508034|SUPERIORITY||Mean Difference (Final Values)|0.13||||0.536|TWO_SIDED|95.0|-0.28|0.53|||t-test, 2 sided||Intention-to-treat analysis|Comparison of change from baseline in height||0.53|-0.28|0.536
72490147|NCT01761084|144508035|SUPERIORITY||Mean Difference (Net)|-0.055||||0.9|TWO_SIDED|95.0|-0.917|0.807|||t-test, 2 sided|||Month 12 scores.||0.807|-0.917|.900
72490148|NCT01761084|144508036|SUPERIORITY||Mean Difference (Final Values)|-5.2|STANDARD_ERROR_OF_MEAN|13.9||0.712|TWO_SIDED|95.0|-33.6|23.2|||t-test, 2 sided|||Baseline||23.2|-33.6|.712
72490149|NCT01761084|144508036|SUPERIORITY||Mean Difference (Final Values)|8.1|STANDARD_ERROR_OF_MEAN|15.3||0.6|TWO_SIDED|95.0|-23.3|39.5|||t-test, 1 sided|||Month 12||39.5|-23.3|.60
72490150|NCT01761084|144508038|SUPERIORITY||Mean Difference (Final Values)|0.15||||0.461|TWO_SIDED|95.0|-0.25|0.55|||t-test, 2 sided||Per-protocol analysis|Comparison of change from baseline in weight||0.55|-0.25|0.461
72490151|NCT01261507|144508039|SUPERIORITY_OR_OTHER||difference in areas under the LROC curve|-0.059|STANDARD_ERROR_OF_MEAN|0.037|<|0.05|TWO_SIDED|95.0|-0.086|-0.031|||mixed model:Dorfman, Berbaum, Metz|||Measure is the difference between the radiologists working without the software less the value for the radiologists working with the software. Thus a negative value would indicate that the the radiologists showed better results when using the software.||-0.031|-0.086|<0.05
72490152|NCT01399788|144508082|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|103.81|||||TWO_SIDED|90.0|99.2|108.64||||||Rifampicin; 32 participants (16 per sequence) provided at least 99% power that 90% confidence interval (CI) for ratio of test to reference for AUClast lie within acceptance region of 80% - 125%. An intra-subject coefficient of variation (CV) estimate of approximately 14.5% for AUClast was used for this power calculation. Natural log transformed AUClast was analyzed using mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||108.64|99.20|
72490153|NCT01399788|144508082|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|107.28|||||TWO_SIDED|90.0|101.95|112.9||||||Isoniazid; 32 participants (16 per sequence) provided at least 99% power that 90% CI for ratio of test to reference for AUClast lie within acceptance region of 80% - 125%. An intra-subject CV estimate of approximately 12.0% for AUClast was used for this power calculation. Natural log transformed AUClast was analyzed using mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||112.90|101.95|
72490154|NCT01399788|144508082|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|99.48|||||TWO_SIDED|90.0|94.92|104.25||||||Ethambutol; 32 participants (16 per sequence) provided at least 99% power that 90% CI for ratio of test to reference for AUClast lie within acceptance region of 80% - 125%. An intra-subject CV estimate of approximately 12.9% for AUClast was used for this power calculation. Natural log transformed AUClast was analyzed using mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||104.25|94.92|
72490155|NCT01399788|144508083|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|102.75|||||TWO_SIDED|90.0|95.36|110.71||||||Rifampicin: 32 participants (16 per sequence) provided at least 98% power that 90% CI for ratio of test to reference for Cmax lie within acceptance region of 80% - 125%. An intra-subject CV estimate of approximately 18.2% for Cmax was used for this power calculation. Natural log transformed Cmax was analyzed using mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||110.71|95.36|
72516493|NCT00643604|144564143|SUPERIORITY_OR_OTHER_LEGACY|||||||0.19||95.0|||||Wilcoxon signed-rank test|||Side-Effects Score. Changes between Baseline and Week 8 were assessed using the Wilcoxon signed rank test. A two-sided p value of \< 0.05 was considered statistically significant. No imputation was used for missing values.||||0.19
72516494|NCT00643604|144564143|SUPERIORITY_OR_OTHER_LEGACY|||||||0.03||95.0|||||Wilcoxon signed-rank test|||Convenience Score. Changes between Baseline and Week 8 were assessed using the Wilcoxon signed rank test. A two-sided p value of \< 0.05 was considered statistically significant. No imputation was used for missing values.||||0.03
72516495|NCT00643604|144564143|SUPERIORITY_OR_OTHER_LEGACY|||||||0.88||95.0|||||Wilcoxon signed-rank test|||Global Satisfaction Score. Changes between Baseline and Week 8 were assessed using the Wilcoxon signed rank test. A two-sided p value of \< 0.05 was considered statistically significant. No imputation was used for missing values.||||0.88
72516496|NCT00643604|144564144|SUPERIORITY_OR_OTHER_LEGACY|||||||0.25||95.0|||||Wilcoxon signed-rank test|||Gather/Set-up. Changes between Baseline and Week 8 were assessed using the Wilcoxon signed rank test. A two-sided p value of \< 0.05 was considered statistically significant. No imputation was used for missing values.||||0.25
72516497|NCT00643604|144564144|SUPERIORITY_OR_OTHER_LEGACY|||||||0.06||95.0|||||Wilcoxon signed-rank test|||Prepare Drug. Changes between Baseline and Week 8 were assessed using the Wilcoxon signed rank test. A two-sided p value of \< 0.05 was considered statistically significant. No imputation was used for missing values.||||0.06
72516498|NCT00643604|144564144|SUPERIORITY_OR_OTHER_LEGACY|||||||0.63||95.0|||||Wilcoxon signed-rank test|||Connect Drug. Changes between Baseline and Week 8 were assessed using the Wilcoxon signed rank test. A two-sided p value of \< 0.05 was considered statistically significant. No imputation was used for missing values.||||0.63
72404491|NCT00811577|144316212|SUPERIORITY_OR_OTHER|||||||0.56||95.0||||For this early phase study, multiple comparisons adjustments were not used.|Wilcoxon (signed rank)|||Using serial gate-keeping to preserve the 5% overall type I error of 1-4 two-sided tests, 2-sided Wilcoxon Signed Rank tests were used. Computer graphics were used to display outcomes at Month 12, compare paired differences of outcomes between the 2 dosages and placebo, and show time trends in mean outcomes. Repeated measures regression models (GEE models in SAS/STAT PROC GENMOD) were used to examine longitudinal outcomes with terms for treatment and trocar location adjusted for key covariates.||||0.56
72404492|NCT00811577|144316212|SUPERIORITY_OR_OTHER|||||||0.61||95.0||||For this early phase study, multiple comparisons adjustments were not used.|Wilcoxon (signed rank)|||Using serial gate-keeping to preserve the 5% overall type I error of 1-4 two-sided tests, 2-sided Wilcoxon Signed Rank tests were used. Computer graphics were used to display outcomes at Month 12, compare paired differences of outcomes between the 2 dosages and placebo, and show time trends in mean outcomes. Repeated measures regression models (GEE models in SAS/STAT PROC GENMOD) were used to examine longitudinal outcomes with terms for treatment and trocar location adjusted for key covariates.||||0.61
72404493|NCT00811577|144316212|SUPERIORITY_OR_OTHER|||||||0.8||95.0||||For this early phase study, multiple comparisons adjustments were not used.|Wilcoxon (signed rank)|||Using serial gate-keeping to preserve the 5% overall type I error of 1-4 two-sided tests, 2-sided Wilcoxon Signed Rank tests were used. Computer graphics were used to display outcomes at Month 12, compare paired differences of outcomes between the 2 dosages and placebo, and show time trends in mean outcomes. Repeated measures regression models (GEE models in SAS/STAT PROC GENMOD) were used to examine longitudinal outcomes with terms for treatment and trocar location adjusted for key covariates.||||0.80
72404494|NCT00811577|144316213|SUPERIORITY_OR_OTHER|||||||0.47||95.0||||For this early phase study, multiple comparisons adjustments were not used.|Wilcoxon (signed rank)|||Using a 100 mm VAS scale, each photograph was assessed by two raters, who, in an end-of-study session, were presented with photographs in their longitudinal sequence, but blinded as to dosage group. These data were used for an inter-rater concordance analysis and also to compare the placebo, 3 and 10 mg dosages.||||0.47
72490156|NCT01399788|144508083|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|103.85|||||TWO_SIDED|90.0|92.13|117.07||||||Isoniazid; 32 participants (16 per sequence) provided at least 98% power that 90% CI for ratio of test to reference for Cmax lie within acceptance region of 80% - 125%. An intra-subject CV estimate of approximately 18.2% for Cmax was used for this power calculation. Natural log transformed Cmax was analyzed using mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||117.07|92.13|
72490157|NCT01399788|144508083|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|99.48|||||TWO_SIDED|90.0|94.92|104.25||||||Ethambutol; 32 participants (16 per sequence) provided at least 99% power that 90% CI for ratio of test to reference for Cmax lie within acceptance region of 80% - 125%. An intra-subject CV estimate of approximately 16.0% for Cmax was used for this power calculation. Natural log transformed Cmax was analyzed using mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||104.25|94.92|
72516499|NCT00643604|144564144|SUPERIORITY_OR_OTHER_LEGACY|||||||0.88||95.0|||||Wilcoxon signed-rank test|||Change Dressing. Changes between Baseline and Week 8 were assessed using the Wilcoxon signed rank test. A two-sided p value of \< 0.05 was considered statistically significant. No imputation was used for missing values.||||0.88
72490158|NCT01399788|144508084|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|101.73|||||TWO_SIDED|90.0|99.12|104.4||||||Pyrazinamide; 32 participants (16 per sequence) provided at least 99% power that 90% CI for ratio of test to reference for AUClast lie within acceptance region of 80% - 125%. An intra-subject CV estimate of approximately 5.2% for AUClast was used for this power calculation. Natural log transformed AUClast(dn) was analyzed using mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||104.40|99.12|
72490159|NCT01399788|144508085|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|95.17|||||TWO_SIDED|90.0|88.6|102.22||||||Pyrazinamide; 32 participants (16 per sequence) provided at least 99% power that 90% CI for ratio of test to reference for Cmax lie within acceptance region of 80% - 125%. An intra-subject CV estimate of approximately 6.7% for Cmax was used for this power calculation. Natural log transformed Cmax(dn) was analyzed using mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||102.22|88.60|
72516500|NCT00643604|144564144|SUPERIORITY_OR_OTHER_LEGACY|||||||0.13||95.0|||||Wilcoxon signed-rank test|||Total Time. Changes between Baseline and Week 8 were assessed using the Wilcoxon signed rank test. A two-sided p value of \< 0.05 was considered statistically significant. No imputation was used for missing values.||||0.13
72516501|NCT00643604|144564145|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5||95.0|||||Wilcoxon signed-rank test|||Changes between Baseline and Week 8 were assessed using the Wilcoxon signed rank test. A two-sided p value of \< 0.05 was considered statistically significant. No imputation was used for missing values.||||0.5
72516502|NCT00643604|144564146|SUPERIORITY_OR_OTHER_LEGACY|||||||0.25||95.0|||||Wilcoxon sign-rank test|||Changes between Baseline and Week 8 were assessed using the Wilcoxon signed rank test. A two-sided p value of \< 0.05 was considered statistically significant. No imputation was used for missing values.||||0.25
72516503|NCT00643604|144564147|SUPERIORITY_OR_OTHER_LEGACY|||||||1||95.0|||||Wilcoxon signed-rank test|||Changes between Baseline and Week 8 were assessed using the Wilcoxon signed rank test. A two-sided p value of \< 0.05 was considered statistically significant. No imputation was used for missing values.||||1.00
72516504|NCT00643604|144564148|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5||95.0|||||Wilcoxon signed-rank test|||Changes between Baseline and Week 8 were assessed using the Wilcoxon signed rank test. A two-sided p value of \< 0.05 was considered statistically significant. No imputation was used for missing values.||||0.50
72568638|NCT04168190|144668504|OTHER|Geometric mean titer (GMT) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMT Ratio|2.13|||||TWO_SIDED|95.0|1.25|3.63|||||Phase 1: V116 0.5 mL/Phase 1: Pneumovax™23|Serotype 15C||3.63|1.25|
72568639|NCT04168190|144668504|OTHER|Geometric mean titer (GMT) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMT Ratio|2.8|||||TWO_SIDED|95.0|1.64|4.79|||||Phase 1: V116 1.0 mL/Phase 1: Pneumovax™23|Serotype 15C||4.79|1.64|
72516505|NCT00643604|144564149|SUPERIORITY_OR_OTHER_LEGACY|||||||1||95.0|||||Wilcoxon signed-rank test|||Changes between Baseline and Week 8 were assessed using the Wilcoxon signed rank test. A two-sided p value of \< 0.05 was considered statistically significant. No imputation was used for missing values.||||1.00
72516506|NCT00643604|144564150|SUPERIORITY_OR_OTHER_LEGACY|||||||1||95.0|||||Wilcoxon signed-rank test|||Changes between Baseline and Week 8 were assessed using the Wilcoxon signed rank test. A two-sided p value of \< 0.05 was considered statistically significant. No imputation was used for missing values.||||1.00
72516507|NCT00643604|144564151|SUPERIORITY_OR_OTHER_LEGACY|||||||1||95.0|||||Wilcoxon signed-rank test|||Changes between Baseline and Week 8 were assessed using the Wilcoxon signed rank test. A two-sided p value of \< 0.05 was considered statistically significant. No imputation was used for missing values.||||1.00
72516508|NCT02702011|144564157|SUPERIORITY_OR_OTHER||Mean Difference (Net)|65.1|STANDARD_ERROR_OF_MEAN|10.81|<|0.0001|TWO_SIDED|95.0|43.29|86.9|||ANCOVA||Mean Difference was calculated as: (mean change from baseline in 24 hour UGE at Day 7 in Empagliflozin 2.5 mg group) - (mean change from baseline in 24 hour UGE at Day 7 in Placebo group)|An analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline as a linear covariate was fitted to the change from baseline of 24 hour UGE (g/24h) on Day 7, where baseline refers to the last observation prior to the first intake of any randomised trial medication.||86.90|43.29|<0.0001
72516509|NCT02702011|144564157|SUPERIORITY_OR_OTHER||Mean Difference (Net)|81.19|STANDARD_ERROR_OF_MEAN|11.1|<|0.0001|TWO_SIDED|95.0|58.8|103.58|||ANCOVA||Mean Difference was calculated as: (mean change from baseline in 24 hour UGE at Day 7 in Empagliflozin 10 mg group) - (mean change from baseline in 24 hour UGE at Day 7 in Placebo group)|An analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline as a linear covariate was fitted to the change from baseline of 24 hour UGE (g/24h) on Day 7, where baseline refers to the last observation prior to the first intake of any randomised trial medication.||103.58|58.80|<0.0001
72516510|NCT02702011|144564157|SUPERIORITY_OR_OTHER||Mean Difference (Net)|98.11|STANDARD_ERROR_OF_MEAN|11.01|<|0.0001|TWO_SIDED|95.0|75.91|120.31|||ANCOVA||Mean Difference was calculated as: (mean change from baseline in 24 hour UGE at Day 7 in Empagliflozin 25 mg group) - (mean change from baseline in 24 hour UGE at Day 7 in Placebo group)|An analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline as a linear covariate was fitted to the change from baseline of 24 hour UGE (g/24h) on Day 7, where baseline refers to the last observation prior to the first intake of any randomised trial medication.||120.31|75.91|<0.0001
72516511|NCT02007954|144564173|OTHER|||||||0.01||||||P-values \< 0.05 considered statistically significant.|t-test, 2 sided|||Shapiro-Wilk test was run for normality. Baseline and follow-up AFP compared using two-tailed Student's t-test.||||.01
72516512|NCT00475540|144564177|SUPERIORITY|Statistical analysis was performed using SAS 9.1 software. One patient did not receive the assigned mesh treatment because the surgeon felt there was inadequate vaginal caliber, so non mesh repair was performed. This subject was analyzed in the non mesh group for the 3-month and 1-year outcomes rather than intent-to-treat approach. This subject was lost to follow-up after 12 months and not included in the 3-year analysis.|||||<|0.05|||||||t-test, 2 sided|t-tests, Wilcoxon signed rank, Wilcoxon rank-sum tests continuous variables; X2 for categorical variables. Combined cure outcomes Fisher's exact test||Sample size primary outcome 1 year: 45 participants per arm, 20% difference success (70% no mesh and 90% mesh), alpha of .05 and 80% power, 15% loss to follow-up.||||<0.05
72516513|NCT01033487|144564186|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0507|STANDARD_ERROR_OF_MEAN|0.0339|||ONE_SIDED|90.0|0.0059||||Emax Model|||Emax model was used with sequence, period and baseline covariate as fixed effects. Lower (1-sided) 90 percent (%) confidence interval (CI) was reported.|||0.0059|
72516514|NCT01033487|144564186|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0788|STANDARD_ERROR_OF_MEAN|0.027|||ONE_SIDED|90.0|0.0431||||Emax Model|||Emax model was used with sequence, period and baseline covariate as fixed effects. Lower (1-sided) 90% CI was reported.|||0.0431|
72516515|NCT01033487|144564186|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0927|STANDARD_ERROR_OF_MEAN|0.0277|||ONE_SIDED|90.0|0.056||||Emax Model|||Emax model was used with sequence, period and baseline covariate as fixed effects. Lower (1-sided) 90% CI was reported.|||0.0560|
72516516|NCT01033487|144564186|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0613|STANDARD_ERROR_OF_MEAN|0.03|||ONE_SIDED|90.0|0.0215||||Emax Model|||Emax model was used with sequence, period and baseline covariate as fixed effects. Lower (1-sided) 90% CI was reported.|||0.0215|
72516517|NCT01033487|144564186|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.0105|STANDARD_ERROR_OF_MEAN|0.0309|||ONE_SIDED|80.0|-0.0371||||Emax Model|||Emax model was used with sequence, period and baseline covariate as fixed effects. Lower (1-sided) 80% CI was reported.|||-0.0371|
72516518|NCT01033487|144564186|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0175|STANDARD_ERROR_OF_MEAN|0.0246|||ONE_SIDED|80.0|-0.0037||||Emax Model|||Emax model was used with sequence, period and baseline covariate as fixed effects. Lower (1-sided) 80% CI was reported.|||-0.0037|
72624392|NCT02507934|144778678|SUPERIORITY||Mean Difference (Final Values)|4.93||||0.0432|TWO_SIDED|95.0|0.16|9.7||For each parameter, for each eye, an ANOVA model for repeated measures has been used by including each available timepoint. The estimated mean difference between treatments (Vismed-Lubricin) over time has been reported and tested.|repeated measures ANOVA|||Analysis of variance for repeated measures on Sticky feeling - Left eye||9.70|0.16|0.0432
72516519|NCT01033487|144564186|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0315|STANDARD_ERROR_OF_MEAN|0.0294|||ONE_SIDED|80.0|0.0062||||Emax Model|||Emax model was used with sequence, period and baseline covariate as fixed effects. Lower (1-sided) 80% CI was reported.|||0.0062|
72516520|NCT01033487|144564195|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0989|STANDARD_ERROR_OF_MEAN|0.242|||ONE_SIDED|90.0|0.0676||||ANOVA|||Mixed effects analysis of variance (ANOVA) was used with sequence, period and baseline covariate as fixed effects, and participant within sequence as a random effect. Lower (1-sided) 90% CI was reported.|||0.0676|
72516521|NCT01033487|144564195|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1748|STANDARD_ERROR_OF_MEAN|0.0245|||ONE_SIDED|90.0|0.1431||||ANOVA|||Mixed effects ANOVA was used with sequence, period and baseline covariate as fixed effects, and participant within sequence as a random effect. Lower (1-sided) 90% CI was reported.|||0.1431|
72516522|NCT01033487|144564195|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1909|STANDARD_ERROR_OF_MEAN|0.0243|||ONE_SIDED|90.0|0.1594||||ANOVA|||Mixed effects ANOVA was used with sequence, period and baseline covariate as fixed effects, and participant within sequence as a random effect. Lower (1-sided) 90% CI was reported.|||0.1594|
72568640|NCT04168190|144668504|OTHER|Geometric mean titer (GMT) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMT Ratio|3.79|||||TWO_SIDED|95.0|1.88|7.67|||||Phase 1: V116 0.5 mL/Phase 1: Pneumovax™23|Serotype 16F||7.67|1.88|
72568641|NCT04168190|144668504|OTHER|Geometric mean titer (GMT) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMT Ratio|5.87|||||TWO_SIDED|95.0|2.88|11.94|||||Phase 1: V116 1.0 mL/Phase 1: Pneumovax™23|Serotype 16F||11.94|2.88|
72568642|NCT04168190|144668504|OTHER|Geometric mean titer (GMT) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMT Ratio|13.76|||||TWO_SIDED|95.0|5.68|33.32|||||Phase 1: V116 0.5 mL/Phase 1: Pneumovax™23|Serotype 23A||33.32|5.68|
72568643|NCT04168190|144668504|OTHER|Geometric mean titer (GMT) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMT Ratio|19.28|||||TWO_SIDED|95.0|7.91|47.0|||||Phase 1: V116 1.0 mL/Phase 1: Pneumovax™23|Serotype 23A||47.00|7.91|
72568644|NCT04168190|144668504|OTHER|Geometric mean titer (GMT) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMT Ratio|23.85|||||TWO_SIDED|95.0|8.64|65.82|||||Phase 1: V116 0.5 mL/Phase 1: Pneumovax™23|Serotype 23B||65.82|8.64|
72568645|NCT04168190|144668504|OTHER|Geometric mean titer (GMT) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMT Ratio|39.39|||||TWO_SIDED|95.0|14.15|109.65|||||Phase 1: V116 1.0 mL/Phase 1: Pneumovax™23|Serotype 23B||109.65|14.15|
72568646|NCT04168190|144668504|OTHER|Geometric mean titer (GMT) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMT Ratio|19.88|||||TWO_SIDED|95.0|9.03|43.74|||||Phase 1: V116 0.5 mL/Phase 1: Pneumovax™23|Serotype 24F||43.74|9.03|
72568647|NCT04168190|144668504|OTHER|Geometric mean titer (GMT) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMT Ratio|31.07|||||TWO_SIDED|95.0|13.98|69.03|||||Phase 1: V116 1.0 mL/Phase 1: Pneumovax™23|Serotype 24F||69.03|13.98|
72624393|NCT02507934|144778678|SUPERIORITY||Mean Difference (Final Values)|6.35||||0.0088|TWO_SIDED|95.0|1.7|11.0||For each parameter, for each eye, an ANOVA model for repeated measures has been used by including each available timepoint. The estimated mean difference between treatments (Vismed-Lubricin) over time has been reported and tested.|repeated measures ANOVA|||Analysis of variance for repeated measures on Sticky feeling - Right eye||11.00|1.70|0.0088
72624394|NCT02507934|144778678|SUPERIORITY||Mean Difference (Final Values)|9.28||||0.0013|TWO_SIDED|95.0|3.9|14.66||For each parameter, for each eye, an ANOVA model for repeated measures has been used by including each available timepoint. The estimated mean difference between treatments (Vismed-Lubricin) over time has been reported and tested.|repeated measures ANOVA|||Analysis of variance for repeated measures on Blurred vision - Left eye||14.66|3.90|0.0013
72490160|NCT01399788|144508086|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|104.3|||||TWO_SIDED|90.0|99.7|109.1||||||Rifampicin; Natural log transformed AUC(0-∞) was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||109.10|99.70|
72490161|NCT01399788|144508086|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|105.74|||||TWO_SIDED|90.0|100.32|111.46||||||Isoniazid; Natural log transformed AUC(0-∞) was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||111.46|100.32|
72624395|NCT02507934|144778678|SUPERIORITY||Mean Difference (Final Values)|5.31||||0.00629|TWO_SIDED|95.0|-0.3|10.92||For each parameter, for each eye, an ANOVA model for repeated measures has been used by including each available timepoint. The estimated mean difference between treatments (Vismed-Lubricin) over time has been reported and tested.|repeated measures ANOVA|||Analysis of variance for repeated measures on Blurred vision - Right eye||10.92|-0.30|0.00629
72490162|NCT01399788|144508086|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|100.97|||||TWO_SIDED|90.0|96.28|105.88||||||Ethambutol; Natural log transformed AUC(0-∞) was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||105.88|96.28|
72490163|NCT01399788|144508087|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|101.8|||||TWO_SIDED|90.0|99.24|104.43||||||Pyrazinamide; Natural log transformed AUC (0 -∞)(dn) was analyzed using mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||104.43|99.24|
72490164|NCT02409290|144508113|SUPERIORITY||Cox Proportional Hazard|0.2||||0.0016|TWO_SIDED|95.0|0.07|0.61|||Log Rank|||||0.61|0.07|0.0016
72490165|NCT02409290|144508114|SUPERIORITY||Cox Proportional Hazard|0.11||||0.0005|TWO_SIDED|95.0|0.03|0.5|||Log Rank|||Control regimen (arm B) uses concurrent controls only||0.50|0.03|0.0005
72490166|NCT00708500|144508115|SUPERIORITY_OR_OTHER||Treatment Difference|37.4|||<|0.0001||95.0|25.7|49.1|||Cochran-Mantel-Haenszel||Difference in percentage of participants who achieved SVR: experimental minus control.|||49.1|25.7|<0.0001
72490167|NCT00708500|144508115|SUPERIORITY_OR_OTHER||Treatment Difference|45.2|||<|0.0001||95.0|33.7|56.8|||Cochran-Mantel-Haenszel||Difference in percentage of participants who achieved SVR: experimental minus control.|||56.8|33.7|<0.0001
72490168|NCT00708500|144508116|SUPERIORITY_OR_OTHER||Treatment Difference|39.1|||<|0.0001||95.0|27.2|51.0|||Cochran-Mantel-Haenszel||Difference in percentage of participants who achieved SVR: experimental minus control.|||51.0|27.2|<0.0001
72490169|NCT00708500|144508116|SUPERIORITY_OR_OTHER||Treatment Difference|45.1|||<|0.0001||95.0|33.4|56.8|||Cochran-Mantel-Haenszel||Difference in percentage of participants who achieved SVR: experimental minus control.|||56.8|33.4|<0.0001
72568648|NCT04168190|144668504|OTHER|Geometric mean titer (GMT) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMT Ratio|57.79|||||TWO_SIDED|95.0|25.15|132.78|||||Phase 1: V116 0.5 mL/Phase 1: Pneumovax™23|Serotype 31||132.78|25.15|
72568649|NCT04168190|144668504|OTHER|Geometric mean titer (GMT) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMT Ratio|58.07|||||TWO_SIDED|95.0|25.1|134.33|||||Phase 1: V116 1.0 mL/Phase 1: Pneumovax™23|Serotype 31||134.33|25.10|
72490170|NCT00705783|144508129|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.199|||<|0.0001|TWO_SIDED|95.0|0.125|0.317|||Log Rank||Aripiprazole depot/placebo depot|Based on 6-month IR rates of 55% for placebo and 35% for aripiprazole, sample sizes were estimated to achieve 90% power to detect a hazard ratio of 0.54 and to preserve an overall nominal alpha level of 0.05 (2-sided), allowing for 2 interim looks at 50% and 75% of events. Assuming that each subject was followed for 12 months after randomization and allowing for a 25% loss to follow-up, the projected total number of subjects to be randomly assigned to treatment in the trial was 225.||0.317|0.125|<0.0001
72516523|NCT01033487|144564195|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1528|STANDARD_ERROR_OF_MEAN|0.0237|||ONE_SIDED|90.0|0.1222||||ANOVA|||Mixed effects ANOVA was used with sequence, period and baseline covariate as fixed effects, and participant within sequence as a random effect. Lower (1-sided) 90% CI was reported.|||0.1222|
72516524|NCT01033487|144564195|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.0539|STANDARD_ERROR_OF_MEAN|0.0239|||ONE_SIDED|90.0|-0.0849||||ANOVA|||Mixed effects ANOVA was used with sequence, period and baseline covariate as fixed effects, and participant within sequence as a random effect. Lower (1-sided) 90% CI was reported.|||-0.0849|
72516525|NCT01033487|144564195|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.022|STANDARD_DEVIATION|0.0238|||ONE_SIDED|90.0|-0.0088||||ANOVA|||Mixed effects ANOVA was used with sequence, period and baseline covariate as fixed effects, and participant within sequence as a random effect. Lower (1-sided) 90% CI was reported.|||-0.0088|
72516526|NCT01033487|144564195|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0381|STANDARD_ERROR_OF_MEAN|0.0242|||ONE_SIDED|90.0|0.0068||||ANOVA|||Mixed effects ANOVA was used with sequence, period and baseline covariate as fixed effects, and participant within sequence as a random effect. Lower (1-sided) 90% CI was reported.|||0.0068|
72516527|NCT01033487|144564196|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0852|STANDARD_ERROR_OF_MEAN|0.0214|||ONE_SIDED|90.0|0.0576||||ANOVA|||Mixed effects ANOVA was used with sequence, period and baseline covariate as fixed effects, and participant within sequence as a random effect. Lower (1-sided) 90% CI was reported.|||0.0576|
72516528|NCT01033487|144564196|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1418|STANDARD_ERROR_OF_MEAN|0.0219|||ONE_SIDED|90.0|0.1136||||ANOVA|||Mixed effects ANOVA was used with sequence, period and baseline covariate as fixed effects, and participant within sequence as a random effect. Lower (1-sided) 90% CI was reported.|||0.1136|
72516529|NCT01033487|144564196|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1692|STANDARD_ERROR_OF_MEAN|0.0216|||ONE_SIDED|90.0|0.1413||||ANOVA|||Mixed effects ANOVA was used with sequence, period and baseline covariate as fixed effects, and participant within sequence as a random effect. Lower (1-sided) 90% CI was reported.|||0.1413|
72516530|NCT01033487|144564196|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1526|STANDARD_ERROR_OF_MEAN|0.0212|||ONE_SIDED|90.0|0.1252||||ANOVA|||Mixed effects ANOVA was used with sequence, period and baseline covariate as fixed effects, and participant within sequence as a random effect. Lower (1-sided) 90% CI was reported.|||0.1252|
72516531|NCT01033487|144564196|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.0674|STANDARD_ERROR_OF_MEAN|0.0211|||ONE_SIDED|90.0|-0.0946||||ANOVA|||Mixed effects ANOVA was used with sequence, period and baseline covariate as fixed effects, and participant within sequence as a random effect. Lower (1-sided) 90% CI was reported.|||-0.0946|
72516532|NCT01033487|144564196|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.0108|STANDARD_ERROR_OF_MEAN|0.0213|||ONE_SIDED|90.0|-0.0383||||ANOVA|||Mixed effects ANOVA was used with sequence, period and baseline covariate as fixed effects, and participant within sequence as a random effect. Lower (1-sided) 90% CI was reported.|||-0.0383|
72516533|NCT01033487|144564196|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0166|STANDARD_ERROR_OF_MEAN|0.213|||ONE_SIDED|90.0|-0.011||||ANOVA|||Mixed effects ANOVA was used with sequence, period and baseline covariate as fixed effects, and participant within sequence as a random effect. Lower (1-sided) 90% CI was reported.|||-0.0110|
72568650|NCT04168190|144668504|OTHER|Geometric mean titer (GMT) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMT Ratio|6.93|||||TWO_SIDED|95.0|4.45|10.8|||||Phase 1: V116 0.5 mL/Phase 1: Pneumovax™23|Serotype 35B||10.80|4.45|
72490171|NCT00705783|144508130|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||The alpha levels for this key secondary Outcome Measure were the same as used for the primary Outcome Measure.|Chi-squared|||||||<0.0001
72490172|NCT00705783|144508131|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Chi-squared|||||||<0.0001
72490173|NCT00705783|144508132|SUPERIORITY_OR_OTHER|||||||0.1756||95.0|||||Chi-squared|||||||0.1756
72490174|NCT00705783|144508133|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.11|||<|0.0001|TWO_SIDED|95.0|-12.68|-7.54|||ANCOVA|The ANCOVA included treatment as a term and baseline as a covariate.||||-7.54|-12.68|<0.0001
72516534|NCT01494987|144564250|SUPERIORITY_OR_OTHER||difference in least squares mean (LSM)|-0.51|||<|0.001|TWO_SIDED|95.0|-0.71|-0.32||P-value is from a mixed-effect model including terms for baseline HbA1c value, prior antihyperglycemia therapy, treatment group, visit week, and treatment by visit week interaction. Unstructured covariance matrix was used.|Mixed Effects Model Analysis||The estimation (LSM) is of the placebo-corrected change from baseline.|Assuming a common standard deviation of 1.2%, an effective sample size of 400 would provide at least 90% power to detect a statistically significant treatment difference of -0.5% (ranolazine vs. placebo) for the reduction of HbA1c from baseline at Week 24 based on a 2-sided alpha of 0.05 and 1:1 randomization.||-0.32|-0.71|<0.001
72516535|NCT03864536|144564255|SUPERIORITY||||||<|0.05||||||The statistical significance level was set using alpha of 0.05 without multiplicity correction. This pilot study was not powered for all the outcomes so the magnitude and estimates of intervention efficacy was of primary interest.|Mixed Models Analysis|||||||<0.05
72516536|NCT03864536|144564256|SUPERIORITY||||||<|0.05||||||The statistical significance level was set using alpha of 0.05 without multiplicity correction. This pilot study was not powered for all the outcomes so the magnitude and estimates of intervention efficacy was of primary interest.|Mixed Models Analysis|||||||<0.05
72516537|NCT00640146|144564257|OTHER|||||||0.0213|||||||Fisher Exact|||Analysis was performed using Fisher exact test comparing the percentage of participants with a laxation response within 2 hours of the first dose of study drug, testing MNTX against placebo.||||0.0213
72490175|NCT00705783|144508134|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.52|||<|0.0001|TWO_SIDED|95.0|-0.7|-0.35|||ANCOVA|The ANCOVA included treatment as a term and baseline as a covariate.||||-0.35|-0.70|<0.0001
72490176|NCT00705783|144508135|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.82|||<|0.0001|TWO_SIDED|95.0|-4.72|-2.91|||ANCOVA|The ANCOVA included treatment as a term and baseline as a covariate.||Positive Subscale Score||-2.91|-4.72|<0.0001
72516538|NCT00640146|144564258|OTHER|||||||0.0463|||||||Fisher Exact|||Analysis was performed using Fisher exact test comparing the percentage of participants with a laxation response within 4 hours of the first dose of study drug, testing MNTX against placebo.||||0.0463
72516539|NCT04058158|144564260|EQUIVALENCE|Pre-defined equivalence margin was \[-337.2 to 337.2\].|Least squares mean difference|34.48|||||TWO_SIDED|95.0|-47.66|116.62||||||||116.62|-47.66|
72516540|NCT04058158|144564261|EQUIVALENCE|Pre-defined equivalence margin was \[0.77 to 1.29\].|Ratio of geometric least squares mean|1.08|||||TWO_SIDED|90.0|0.95|1.23||||||||1.23|0.95|
72516541|NCT04847141|144564262|SUPERIORITY||Difference in Percentage|-3.6||||0.5167|TWO_SIDED|95.0|-14.6|7.4||p-value was calculated using Chi-square test with 5% level of significance to test the null hypothesis of no difference in the percentage of participants meeting the primary efficacy endpoint between C19-IG 20% 1 g and placebo.|Chi-squared||95% CI for percentage difference between C19-IG 20% 1 g dose group and placebo was calculated using the exact unconditional method.|||7.4|-14.6|0.5167
72516542|NCT04847141|144564262|SUPERIORITY||Difference in Percentage|1.2||||0.8197|TWO_SIDED|95.0|-9.6|12.0||p-value was calculated using Chi-square test with 5% level of significance to test the null hypothesis of no difference in the percentage of participants meeting the primary efficacy endpoint between C19-IG 20% 2 g and placebo.|Chi-squared||95% CI for percentage difference between C19-IG 20% 2 g dose group and placebo was calculated using the exact unconditional method.|||12.0|-9.6|0.8197
72516543|NCT04847141|144564263|SUPERIORITY||Least squares (LS) Mean Difference|0.1||||0.5756|TWO_SIDED|95.0|-0.24|0.44|||ANCOVA||95% CI for the difference in LS Mean between 1 g C19-IG 20% dose group \& placebo was calculated using ANCOVA model, including CFB value as dependent variable; treatment group as fixed effect; \& baseline viral load value, age, \& gender as covariates.|Day 7||0.44|-0.24|0.5756
72516544|NCT04847141|144564263|SUPERIORITY||LS Mean Difference|-0.17||||0.3289|TWO_SIDED|95.0|-0.52|0.17|||ANCOVA||95% CI for the difference in LS Mean between 2 g C19-IG 20% dose group \& placebo was calculated using ANCOVA model, including CFB value as dependent variable; treatment group as fixed effect; \& baseline viral load value, age, \& gender as covariates.|Day 7||0.17|-0.52|0.3289
72516545|NCT04847141|144564263|SUPERIORITY||LS Mean Difference|0.11||||0.3418|TWO_SIDED|95.0|-0.12|0.34|||ANCOVA||95% CI for the difference in LS Mean between 1 g C19-IG 20% dose group \& placebo was calculated using ANCOVA model, including CFB value as dependent variable; treatment group as fixed effect; \& baseline viral load value, age, \& gender as covariates.|Day 14||0.34|-0.12|0.3418
72516546|NCT04847141|144564263|SUPERIORITY||LS Mean Difference|-0.11||||0.3688|TWO_SIDED|95.0|-0.34|0.13|||ANCOVA||95% CI for the difference in LS Mean between 2 g C19-IG 20% dose group \& placebo was calculated using ANCOVA model, including CFB value as dependent variable; treatment group as fixed effect; \& baseline viral load value, age, \& gender as covariates.|Day 14||0.13|-0.34|0.3688
72516547|NCT04847141|144564264|SUPERIORITY||Difference in Percentage|-1.3||||0.1506|TWO_SIDED|95.0|-4.7|1.2||p-value was calculated using Chi-square test with 5% level of significance to test the null hypothesis of no difference in the percentage of participants who remained in an outpatient setting \& maintained SpO2≥94% between C19-IG 20% 2 g \& placebo.|Chi-squared||95% CI for percentage difference between C19-IG 20% 2 g dose group and placebo was calculated using the exact unconditional method.|Day 3||1.2|-4.7|0.1506
72516548|NCT04847141|144564264|SUPERIORITY||Difference in Percentage|1.3||||0.1655|TWO_SIDED|95.0|-1.3|4.6||p-value was calculated using Chi-square test with 5% level of significance to test the null hypothesis of no difference in the percentage of participants who remained in an outpatient setting \& maintained SpO2≥94% between C19-IG 20% 1 g \& placebo.|Chi-squared||95% CI for percentage difference between C19-IG 20% 1 g dose group and placebo was calculated using the exact unconditional method.|Day 7||4.6|-1.3|0.1655
72516549|NCT04847141|144564264|SUPERIORITY||Difference in Percentage|-2.0||||0.2337|TWO_SIDED|95.0|-6.5|1.7||p-value was calculated using Chi-square test with 5% level of significance to test the null hypothesis of no difference in the percentage of participants who remained in an outpatient setting \& maintained SpO2≥94% between C19-IG 20% 2 g \& placebo.|Chi-squared||95% CI for percentage difference between C19-IG 20% 2 g dose group and placebo was calculated using the exact unconditional method.|Day 7||1.7|-6.5|0.2337
72568651|NCT04168190|144668504|OTHER|Geometric mean titer (GMT) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMT Ratio|7.82|||||TWO_SIDED|95.0|5.0|12.24|||||Phase 1: V116 1.0 mL/Phase 1: Pneumovax™23|Serotype 35B||12.24|5.00|
72490177|NCT00705783|144508136|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.36||||0.0001|TWO_SIDED|95.0|-2.04|-0.67|||ANCOVA|The ANCOVA included treatment as a term and baseline as a covariate.||||-0.67|-2.04|0.0001
72490178|NCT00705783|144508137|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Cochran-Mantel-Haenszel|||||||<0.0001
72490179|NCT00705783|144508138|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Log Rank|||||||<0.0001
72490180|NCT02184195|144508139|SUPERIORITY||Hazard Ratio (HR)|0.531||||0.0038|TWO_SIDED|95.0|0.346|0.815|||Log-rank test|||||0.815|0.346|0.0038
72490181|NCT02184195|144508140|OTHER||Hazard Ratio (HR)|0.831||||0.3487|TWO_SIDED|95.0|0.564|1.224|||Log-rank test|||||1.224|0.564|0.3487
72516550|NCT04847141|144564264|SUPERIORITY||Difference in Percentage|-0.8||||0.7212|TWO_SIDED|95.0|-6.1|4.2||p-value was calculated using Chi-square test with 5% level of significance to test the null hypothesis of no difference in the percentage of participants who remained in an outpatient setting \& maintained SpO2≥94% between C19-IG 20% 1 g \& placebo.|Chi-squared||95% CI for percentage difference between C19-IG 20% 1 g dose group and placebo was calculated using the exact unconditional method.|Day 14||4.2|-6.1|0.7212
72490182|NCT02184195|144508141|SUPERIORITY||Hazard Ratio (HR)|0.659||||0.0613|TWO_SIDED|95.0|0.426|1.02|||Log-rank test|||||1.020|0.426|0.0613
72404495|NCT00811577|144316213|SUPERIORITY_OR_OTHER|||||||0.08||95.0||||For this early phase study, multiple comparisons adjustments were not used.|Wilcoxon (signed rank)|||Using a 100 mm VAS scale, each photograph was assessed by two raters, who, in an end-of-study session, were presented with photographs in their longitudinal sequence, but blinded as to dosage group. These data were used for an inter-rater concordance analysis and also to compare the placebo, 3 and 10 mg dosages.||||0.080
72404496|NCT00811577|144316213|SUPERIORITY_OR_OTHER|||||||0.96||95.0||||For this early phase study, multiple comparisons adjustments were not used.|Wilcoxon (signed rank)|||Using a 100 mm VAS scale, each photograph was assessed by two raters, who, in an end-of-study session, were presented with photographs in their longitudinal sequence, but blinded as to dosage group. These data were used for an inter-rater concordance analysis and also to compare the placebo, 3 and 10 mg dosages.||||0.96
72516551|NCT04847141|144564264|SUPERIORITY||Difference in Percentage|-2.1||||0.3897|TWO_SIDED|95.0|-7.8|3.1||p-value was calculated using Chi-square test with 5% level of significance to test the null hypothesis of no difference in the percentage of participants who remained in an outpatient setting \& maintained SpO2≥94% between C19-IG 20% 2 g \& placebo.|Chi-squared||95% CI for percentage difference between C19-IG 20% 2 g dose group and placebo was calculated using the exact unconditional method.|Day 14||3.1|-7.8|0.3897
72516552|NCT04847141|144564265|SUPERIORITY||Difference in Percentage|3.1||||0.5489|TWO_SIDED|95.0|-7.1|13.3||p-value was calculated using Chi-square test with 5% level of significance to test the null hypothesis of no difference in the percentage of participants who had a negative test result between C19-IG 20% 1 g dose group and placebo.|Chi-squared||95% CI for percentage difference between C19-IG 20% 1 g dose group and placebo was calculated using the exact unconditional method.|Day 3||13.3|-7.1|0.5489
72516553|NCT04847141|144564265|SUPERIORITY||Difference in Percentage|4.4||||0.392|TWO_SIDED|95.0|-5.8|14.7||p-value was calculated using Chi-square test with 5% level of significance to test the null hypothesis of no difference in the percentage of participants who had a negative test result between C19-IG 20% 2 g dose group and placebo.|Chi-squared||95% CI for percentage difference between C19-IG 20% 2 g dose group and placebo was calculated using the exact unconditional method.|Day 3||14.7|-5.8|0.3920
72516554|NCT04847141|144564265|SUPERIORITY||Difference in Percentage|1.7||||0.7632|TWO_SIDED|95.0|-9.5|12.9||p-value was calculated using Chi-square test with 5% level of significance to test the null hypothesis of no difference in the percentage of participants who had a negative test result between C19-IG 20% 1 g dose group and placebo.|Chi-squared||95% CI for percentage difference between C19-IG 20% 1 g dose group and placebo was calculated using the exact unconditional method.|Day 7||12.9|-9.5|0.7632
72516555|NCT04847141|144564265|SUPERIORITY||Difference in Percentage|7.9||||0.1702|TWO_SIDED|95.0|-3.6|19.2||p-value was calculated using Chi-square test with 5% level of significance to test the null hypothesis of no difference in the percentage of participants who had a negative test result between C19-IG 20% 2 g dose group and placebo.|Chi-squared||95% CI for percentage difference between C19-IG 20% 2 g dose group and placebo was calculated using the exact unconditional method.|Day 7||19.2|-3.6|0.1702
72516556|NCT04847141|144564265|SUPERIORITY||Difference in Percentage|-2.0||||0.7316|TWO_SIDED|95.0|-13.3|9.4||p-value was calculated using Chi-square test with 5% level of significance to test the null hypothesis of no difference in the percentage of participants who had a negative test result between C19-IG 20% 1 g dose group and placebo.|Chi-squared||95% CI for percentage difference between C19-IG 20% 1 g dose group and placebo was calculated using the exact unconditional method.|Day 14||9.4|-13.3|0.7316
72516557|NCT04847141|144564265|SUPERIORITY||Difference in Percentage|6.9||||0.2104|TWO_SIDED|95.0|-4.2|18.0||p-value was calculated using Chi-square test with 5% level of significance to test the null hypothesis of no difference in the percentage of participants who had a negative test result between C19-IG 20% 2 g dose group and placebo.|Chi-squared||95% CI for percentage difference between C19-IG 20% 2 g dose group and placebo was calculated using the exact unconditional method.|Day 14||18.0|-4.2|0.2104
72568652|NCT04168190|144668507|NON_INFERIORITY|Non-inferiority can be concluded if the lower bound of the 95% CI for the estimated GMC ratio (V116/PPSV23) is \>0.5 (1-sided p-value \<0.025).|GMC Ratio|1.08|||<|0.001|TWO_SIDED|95.0|0.9|1.3|||P-value is estimated from a cLDA model.||Phase 2: V116/Phase 2: Pneumovax™23|Serotype 3. Geometric mean concentration (GMC) ratio, 95% confidence interval (CI), and p-value are estimated from a constrained longitudinal data analysis (cLDA) model.||1.30|0.90|<0.001
72490183|NCT02184195|144508142|SUPERIORITY||Hazard Ratio (HR)|0.611||||0.0111|TWO_SIDED|95.0|0.418|0.894|||Log-rank test|||||0.894|0.418|0.0111
72490184|NCT02184195|144508143|SUPERIORITY||Hazard Ratio (HR)|0.442|||<|0.0001|TWO_SIDED|95.0|0.297|0.658|||Log-rank test|||||0.658|0.297|<0.0001
72490185|NCT02184195|144508144|SUPERIORITY||Hazard Ratio (HR)|0.425|||<|0.0001|TWO_SIDED|95.0|0.289|0.627|||Log-rank test|||||0.627|0.289|<0.0001
72490186|NCT02184195|144508145|SUPERIORITY||Odds Ratio (OR)|1.52||||0.3273|TWO_SIDED|95.0|0.668|3.61|||Regression, Logistic|||||3.610|0.668|0.3273
72490187|NCT02184195|144508147|SUPERIORITY||Mean Difference (Final Values)|-2.21||||0.355|TWO_SIDED|95.0|-6.917|2.496|||Mixed Models Analysis|||||2.496|-6.917|0.355
72490188|NCT02997735|144508152|SUPERIORITY||Odds Ratio (OR)|7.78|||<|0.001|TWO_SIDED|95.0|2.81|27.9|||Chi-squared||ORs from multivariable logistic regression model of characteristics associated with successful quitline enrollment.|||27.90|2.81|<0.001
72490189|NCT02997735|144508153|SUPERIORITY||Odds Ratio (OR)|0.48||||0.15|TWO_SIDED|95.0|0.13|1.72|||Chi-squared||1-5 years Row (\<1 Ref)|||1.72|0.13|0.15
72490190|NCT02997735|144508153|SUPERIORITY||Odds Ratio (OR)|0.61|||||TWO_SIDED|95.0|0.18|2.12|||||6-12 years Row (\<1 Ref)|||2.12|0.18|
72490191|NCT02997735|144508153|SUPERIORITY||Odds Ratio (OR)|1.82|||||TWO_SIDED|95.0|0.49|6.94|||||13 or Older Row (\<1 Ref)|||6.94|0.49|
72490192|NCT02997735|144508154|SUPERIORITY||Odds Ratio (OR)|2.38||||0.028|TWO_SIDED|95.0|0.92|6.5|||Chi-squared||35-49 years Row (18-34 Ref)|||6.50|0.92|0.028
72490193|NCT02997735|144508154|SUPERIORITY||Odds Ratio (OR)|5.1|||||TWO_SIDED|95.0|1.46|17.32|||||50 or older Row (18-34 Ref)|||17.32|1.46|
72490194|NCT02997735|144508155|SUPERIORITY||Odds Ratio (OR)|1.1||||0.85|TWO_SIDED|95.0|0.4|2.8|||Chi-squared||Asthma Row (No asthma Ref)|||2.80|0.40|0.85
72490195|NCT02997735|144508156|SUPERIORITY||Odds Ratio (OR)|2.07||||0.086|TWO_SIDED|95.0|0.9|6.5|||Chi-squared||10 or more cigarettes Row (\<10 cigarettes Ref)|||6.50|0.90|0.086
72490196|NCT02997735|144508157|SUPERIORITY||Odds Ratio (OR)|0.47||||0.35|TWO_SIDED|95.0|0.15|1.27|||Chi-squared||Less than 6 months Row (30 days Ref)|||1.27|0.15|0.35
72490197|NCT02997735|144508157|SUPERIORITY||Odds Ratio (OR)|0.67|||||TWO_SIDED|95.0|0.15|2.21|||||||6 or more months Row (30 days Ref)|2.21|0.15|
72490198|NCT01664559|144508177|SUPERIORITY_OR_OTHER|||||||0.99|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.99
72490199|NCT01664559|144508178|SUPERIORITY_OR_OTHER|||||||0.31|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||1\) Anticipated pain||||0.31
72490200|NCT01664559|144508178|SUPERIORITY_OR_OTHER|||||||0.33|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||2\) pain with injection||||0.33
72490201|NCT01664559|144508178|SUPERIORITY_OR_OTHER|||||||0.72|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||3\) speculum insertion||||0.72
72490202|NCT01664559|144508178|SUPERIORITY_OR_OTHER|||||||0.36|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||4\) tenaculum placement||||0.36
72490203|NCT01664559|144508178|SUPERIORITY_OR_OTHER|||||||0.64|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||5\) uterine sounding||||0.64
72490204|NCT01664559|144508178|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||6\) 5 min after placement||||<0.001
72490205|NCT01664559|144508178|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||7\) 15 min after placement||||<0.001
72490206|NCT01664559|144508179|SUPERIORITY_OR_OTHER|||||||0.6|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||1\) anticipated pain||||0.6
72490207|NCT01664559|144508179|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||2\) pain with injection||||1.0
72490208|NCT01664559|144508179|SUPERIORITY_OR_OTHER|||||||0.34|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||3\) speculum insertion||||0.34
72490209|NCT01664559|144508179|SUPERIORITY_OR_OTHER|||||||0.32|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||4\) tenaculum placement||||0.32
72490210|NCT01664559|144508179|SUPERIORITY_OR_OTHER|||||||0.04|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||5\) uterine sounding||||0.04
72490211|NCT01664559|144508179|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||6\) IUD placement||||0.02
72490212|NCT01664559|144508179|SUPERIORITY_OR_OTHER|||||||0.32|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||7\) 5 min after placement||||0.32
72490213|NCT01664559|144508179|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||8\) 15 min after placement||||0.02
72490214|NCT01664559|144508180|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Chi-squared|||Reported side effects (nausea, vomiting, dyspepsia, headache, dizziness, drowsiness, injection site itchiness, swelling or pain)||||> 0.05
72490215|NCT01664559|144508180|SUPERIORITY_OR_OTHER|||||||0.76|TWO_SIDED||||||Chi-squared|||Injection site pain (just as bad or worse than IUD procedure)||||0.76
72490216|NCT01664559|144508180|SUPERIORITY_OR_OTHER|||||||0.76|TWO_SIDED||||||Chi-squared|||Satisfied or very satisfied with IUD placement procedure||||0.76
72490217|NCT01664559|144508180|SUPERIORITY_OR_OTHER|||||||0.35|TWO_SIDED||||||Chi-squared|||Would recommend IUD placement to a friend||||0.35
72490218|NCT01664559|144508180|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED||||||Chi-squared|||Desires additional pain medication||||0.02
72490219|NCT01664559|144508181|SUPERIORITY_OR_OTHER|||||||0.2|TWO_SIDED||||||Chi-squared|||Level of training, PGY 1, 2, 3, 4 and Attending||||0.2
72490220|NCT01664559|144508181|SUPERIORITY_OR_OTHER|||||||0.09|TWO_SIDED||||||Chi-squared|||IUD type (levonorgestrel or copper)||||0.09
72490221|NCT01664559|144508181|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Chi-squared|||Purpose of IUD (contraception or heavy menstrual bleeding)||||1.0
72490222|NCT01664559|144508181|SUPERIORITY_OR_OTHER|||||||0.92|TWO_SIDED||||||Chi-squared|||Position of uterus (anteverted, retroverted, midpositioned)||||0.92
72490223|NCT01664559|144508181|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Chi-squared|||Need for cervical dilation||||1.0
72490224|NCT01664559|144508181|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Chi-squared, Corrected|||Able to complete the IUD insertion||||1.0
72490225|NCT01664559|144508181|SUPERIORITY_OR_OTHER|||||||0.24|TWO_SIDED||||||Chi-squared|||Significant bleeding||||0.24
72490226|NCT01664559|144508181|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Chi-squared|||Major complications||||1.0
72490227|NCT01664559|144508181|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED||||||Chi-squared|||Took acetaminophen prior to leaving the office||||0.02
72490228|NCT02255409|144508215|OTHER||Mean Difference (Final Values)|1.5|||||TWO_SIDED|95.0|-6.7|9.7||||||Vaccine Group Difference (aQIV - QIV) for A/H1N1 at Day 22||9.7|-6.7|
72490229|NCT02255409|144508215|OTHER||Mean Difference (Final Values)|-6.0|||||TWO_SIDED|95.0|-14.2|2.3||||||Vaccine Group Difference (aQIV - QIV) for A/H3N2 at Day 22||2.3|-14.2|
72490230|NCT02255409|144508215|OTHER||Mean Difference (Final Values)|16.3|||||TWO_SIDED|95.0|8.4|24.1||||||Vaccine Group Difference (aQIV - QIV) for B/Yamagata at Day 22||24.1|8.4|
72490231|NCT02255409|144508215|OTHER||Mean Difference (Final Values)|14.2|||||TWO_SIDED|95.0|6.3|22.0||||||Vaccine Group Difference (aQIV - QIV) for B/Victoria at Day 22||22.0|6.3|
72490232|NCT02255409|144508216|OTHER||Mean Difference (Final Values)|0.4|||||TWO_SIDED|95.0|-0.9|2.2||||||Vaccine Group Difference (aQIV - QIV) for A/H1N1 at Day 22||2.2|-0.9|
72490233|NCT02255409|144508216|OTHER||Mean Difference (Final Values)|-0.3|||||TWO_SIDED|95.0|-1.9|1.2||||||Vaccine Group Difference (aQIV - QIV) for A/H3N2 at Day 22||1.2|-1.9|
72490234|NCT02255409|144508216|OTHER||Mean Difference (Final Values)|14.4|||||TWO_SIDED|95.0|9.3|20.0||||||Vaccine Group Difference (aQIV - QIV) for B/Yamagata at Day 22||20.0|9.3|
72490235|NCT02255409|144508216|OTHER||Mean Difference (Final Values)|26.0|||||TWO_SIDED|95.0|20.6|32.0||||||Vaccine Group Difference (aQIV - QIV) for B/Victoria at Day 22||32.0|20.6|
72490236|NCT02255409|144508220|OTHER||Mean Difference (Final Values)|5.8|||||TWO_SIDED|95.0|-1.6|13.0||||||Vaccine Group Difference (aQIV - QIV) for A/H1N1 at Day 181||13.0|-1.6|
72624396|NCT02507934|144778678|SUPERIORITY||Mean Difference (Final Values)|9.92||||0.002|TWO_SIDED|95.0|3.89|15.95||For each parameter, for each eye, an ANOVA model for repeated measures has been used by including each available timepoint. The estimated mean difference between treatments (Vismed-Lubricin) over time has been reported and tested.|repeated measures ANOVA|||Analysis of variance for repeated measures on Photophobia - Left eye||15.95|3.89|0.0020
72490237|NCT02255409|144508220|OTHER||Mean Difference (Final Values)|2.2|||||TWO_SIDED|95.0|-5.5|9.8||||||Vaccine Group Difference (aQIV - QIV) for A/H3N2 at Day 181||9.8|-5.5|
72490238|NCT02255409|144508220|OTHER||Mean Difference (Final Values)|11.8|||||TWO_SIDED|95.0|5.3|18.3||||||Vaccine Group Difference (aQIV - QIV) for B/Yamagata at Day 181||18.3|5.3|
72490239|NCT02255409|144508220|OTHER||Mean Difference (Final Values)|-1.3|||||TWO_SIDED|95.0|-8.4|5.7||||||Vaccine Group Difference (aQIV - QIV) for B/Victoria at Day 181||5.7|-8.4|
72490240|NCT02255409|144508221|OTHER||Mean Difference (Final Values)|4.8|||||TWO_SIDED|95.0|2.4|8.4||||||Vaccine Group Difference (aQIV - QIV) for A/H1N1 at Day 181||8.4|2.4|
72490241|NCT02255409|144508221|OTHER||Mean Difference (Final Values)|5.6|||||TWO_SIDED|95.0|3.1|9.3||||||Vaccine Group Difference (aQIV - QIV) for A/H3N2 at Day 181||9.3|3.1|
72490242|NCT02255409|144508221|OTHER||Mean Difference (Final Values)|33.2|||||TWO_SIDED|95.0|25.0|40.9||||||Vaccine Group Difference (aQIV - QIV) for B/Yamagata at Day 181||40.9|25.0|
72516558|NCT04847141|144564265|SUPERIORITY||Difference in Percentage|4.9||||0.2059|TWO_SIDED|95.0|-2.9|13.2||p-value was calculated using Chi-square test with 5% level of significance to test the null hypothesis of no difference in the percentage of participants who had a negative test result between C19-IG 20% 1 g dose group and placebo.|Chi-squared||95% CI for percentage difference between C19-IG 20% 1 g dose group and placebo was calculated using the exact unconditional method.|Day 29||13.2|-2.9|0.2059
72404497|NCT00811577|144316213|SUPERIORITY_OR_OTHER|||||||0.22||95.0||||For this early phase study, multiple comparisons adjustments were not used.|Wilcoxon (signed rank)|||Using a 100 mm VAS scale, each photograph was assessed by two raters, who, in an end-of-study session, were presented with photographs in their longitudinal sequence, but blinded as to dosage group. These data were used for an inter-rater concordance analysis and also to compare the placebo, 3 and 10 mg dosages.||||0.22
72490243|NCT02255409|144508221|OTHER||Mean Difference (Final Values)|37.3|||||TWO_SIDED|95.0|29.6|44.7||||||Vaccine Group Difference (aQIV - QIV) for B/Victoria at Day 181||44.7|29.6|
72490244|NCT02255409|144508222|OTHER||GMT Ratio|1.94|||||TWO_SIDED|95.0|1.6|2.4||||||The ratio of GMT (GMTr) values between aQIV vs. QIV (ie, GMT\[aQIV\]:GMT\[QIV\]) for A/H1N1 at Day 1.||2.4|1.6|
72490245|NCT02255409|144508222|OTHER||GMT Ratio|1.48|||||TWO_SIDED|95.0|1.3|1.7||||||GMTr values between aQIV vs. QIV (ie, GMT\[aQIV\]:GMT\[QIV\]) for A/H1N1 at Day 22.||1.7|1.3|
72490246|NCT02255409|144508222|OTHER||GMT Ratio|1.5|||||TWO_SIDED|95.0|1.3|1.7||||||GMTr values between aQIV vs. QIV (ie, GMT\[aQIV\]:GMT\[QIV\]) for A/H1N1 at Day 181.||1.7|1.3|
72490247|NCT02255409|144508222|OTHER||GMT Ratio|2.16|||||TWO_SIDED|95.0|1.7|2.7||||||GMTr values between aQIV vs. QIV (ie, GMT\[aQIV\]:GMT\[QIV\]) for A/H3N2 at Day 1.||2.7|1.7|
72490248|NCT02255409|144508222|OTHER||GMT Ratio|1.34|||||TWO_SIDED|95.0|1.2|1.5||||||GMTr values between aQIV vs. QIV (ie, GMT\[aQIV\]:GMT\[QIV\]) for A/H3N2 at Day 22.||1.5|1.2|
72490249|NCT02255409|144508222|OTHER||GMT Ratio|1.34|||||TWO_SIDED|95.0|1.2|1.6||||||GMTr values between aQIV vs. QIV (ie, GMT\[aQIV\]:GMT\[QIV\]) for A/H3N2 at Day 181.||1.6|1.2|
72490250|NCT02255409|144508222|OTHER||GMT Ratio|1.82|||||TWO_SIDED|95.0|1.5|2.2||||||GMTr values between aQIV vs. QIV (ie, GMT\[aQIV\]:GMT\[QIV\]) for B/Yamagata at Day 1.||2.2|1.5|
72490251|NCT02255409|144508222|OTHER||GMT Ratio|1.75|||||TWO_SIDED|95.0|1.5|2.0||||||GMTr values between aQIV vs. QIV (ie, GMT\[aQIV\]:GMT\[QIV\]) for B/Yamagata at Day 22.||2.0|1.5|
72490252|NCT02255409|144508222|OTHER||GMT Ratio|1.85|||||TWO_SIDED|95.0|1.6|2.2||||||GMTr values between aQIV vs. QIV (ie, GMT\[aQIV\]:GMT\[QIV\]) for B/Yamagata at Day 181.||2.2|1.6|
72490253|NCT02255409|144508222|OTHER||GMT Ratio|3.24|||||TWO_SIDED|95.0|2.7|4.0||||||GMTr values between aQIV vs. QIV (ie, GMT\[aQIV\]:GMT\[QIV\]) for B/Victoria at Day 1.||4.0|2.7|
72490254|NCT02255409|144508222|OTHER||GMT Ratio|1.49|||||TWO_SIDED|95.0|1.2|1.8||||||GMTr values between aQIV vs. QIV (ie, GMT\[aQIV\]:GMT\[QIV\]) for B/Victoria at Day 22.||1.8|1.2|
72490255|NCT02255409|144508222|OTHER||GMT Ratio|1.29|||||TWO_SIDED|95.0|1.1|1.5||||||GMTr values between aQIV vs. QIV (ie, GMT\[aQIV\]:GMT\[QIV\]) for B/Victoria at Day 181.||1.5|1.1|
72490256|NCT02255409|144508224|OTHER||Mean Difference (Final Values)|5.7|||||TWO_SIDED|95.0|-5.2|16.3||||||Vaccine Group Difference (aQIV - QIV) for A/H3N2 at Day 181||16.3|-5.2|
72490257|NCT02255409|144508224|OTHER||Mean Difference (Final Values)|14.5|||||TWO_SIDED|95.0|5.3|23.6||||||Vaccine Group Difference (aQIV - QIV) for B/Yamagata at Day 181||23.6|5.3|
72490258|NCT02255409|144508225|OTHER||Mean Difference (Final Values)|16.3|||||TWO_SIDED|95.0|9.5|24.1||||||Vaccine Group Difference (aQIV - QIV) for A/H3N2 at Day 181||24.1|9.5|
72490259|NCT02255409|144508225|OTHER||Mean Difference (Final Values)|46.4|||||TWO_SIDED|95.0|35.9|55.8||||||Vaccine Group Difference (aQIV - QIV) for B/Yamagata at Day 181||55.8|35.9|
72490260|NCT02255409|144508226|OTHER||GMT Ratio|2.63|||||TWO_SIDED|95.0|1.8|3.8||||||GMTr values between aQIV vs. QIV (ie, GMT\[aQIV\]:GMT\[QIV\]) for A/H3N2 at Day 1.||3.8|1.8|
72490261|NCT02255409|144508226|OTHER||GMT Ratio|1.57|||||TWO_SIDED|95.0|1.3|2.9||||||GMTr values between aQIV vs. QIV (ie, GMT\[aQIV\]:GMT\[QIV\]) for A/H3N2 at Day 22.||2.9|1.3|
72490262|NCT02255409|144508226|OTHER||GMT Ratio|1.7|||||TWO_SIDED|95.0|1.3|2.2||||||GMTr values between aQIV vs. QIV (ie, GMT\[aQIV\]:GMT\[QIV\]) for A/H3N2 at Day 181.||2.2|1.3|
72490263|NCT02255409|144508226|OTHER||GMT Ratio|1.99|||||TWO_SIDED|95.0|1.5|2.6||||||GMTr values between aQIV vs. QIV (ie, GMT\[aQIV\]:GMT\[QIV\]) for B/Yamagata at Day 1.||2.6|1.5|
72490264|NCT02255409|144508226|OTHER||GMT Ratio|2.21|||||TWO_SIDED|95.0|1.8|2.7||||||GMTr values between aQIV vs. QIV (ie, GMT\[aQIV\]:GMT\[QIV\]) for A/H3N2 at Day 22.||2.7|1.8|
72490265|NCT02255409|144508226|OTHER||GMT Ratio|2.55|||||TWO_SIDED|95.0|2.1|3.2||||||GMTr values between aQIV vs. QIV (ie, GMT\[aQIV\]:GMT\[QIV\]) for A/H3N2 at Day 181.||3.2|2.1|
72490266|NCT02189213|144508228|OTHER|The parameters were the CGI-Improvement scale which comprises a one-item measures evaluating the following change from the initiation of treatment on a seven-point scale. The hypothesis is that \~50% of subjects receiving treatment will not respond.|||||=|0.0002|||||||t-test, 2 sided|||At least 50% of subjects will respond to Sertraline treatment (CGI greater than or equal to 2).||||=0.0002
72490267|NCT00345176|144508267|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.9|||<|0.013|TWO_SIDED|98.7|0.76|1.07||Adjusted for 3 treatment versus placebo comparisons and interim analyses|Regression, Cox|Adjusted for baseline AMD status|The reference group is placebo.|Each of the 3 active arms was compared to the placebo/control arm.||1.07|0.76|<0.013
72490268|NCT00345176|144508267|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.97|||<|0.013|TWO_SIDED|98.7|0.82|1.16||Adjusted for multiple comparisons|Regression, Cox|||||1.16|0.82|<0.013
72490269|NCT00345176|144508267|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.89|||<|0.013|TWO_SIDED|98.7|0.75|1.06|||Regression, Cox|Adjusted for multiple comparisons||||1.06|0.75|<0.013
72490270|NCT00345176|144508268|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.95|||<|0.05|TWO_SIDED|95.0|0.84|1.08|||Regression, Cox|||||1.08|0.84|<0.05
72490271|NCT00345176|144508268|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.96|||<|0.05|TWO_SIDED|95.0|0.84|1.09|||Regression, Cox|||||1.09|0.84|<0.05
72490272|NCT00345176|144508268|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.94|||<|0.05|TWO_SIDED|95.0|0.83|1.07|||Regression, Cox|||||1.07|0.83|<0.05
72490273|NCT00345176|144508269|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.04|||<|0.05|TWO_SIDED|95.0|0.77|1.4|||Regression, Cox|||Comparison of Lutein/Zeaxantin versus Control for mortality||1.40|0.77|<0.05
72490274|NCT00345176|144508269|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.13|||<|0.05|TWO_SIDED|95.0|0.84|1.52|||Regression, Cox|||Comparison of DHA/EPA versus Placebo for mortality||1.52|0.84|<0.05
72490275|NCT00345176|144508269|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.23|||<|0.05|TWO_SIDED|95.0|0.92|1.65|||Regression, Cox|||Comparison of Lutein/Zeaxanthin + DHA/EPA versus Placebo for Mortality||1.65|0.92|<0.05
72490276|NCT00345176|144508270|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.96|||<|0.05|TWO_SIDED|95.0|0.84|1.1|||Regression, Cox|||||1.10|0.84|<0.05
72490277|NCT02370615|144508276|SUPERIORITY_OR_OTHER||Geometric Mean Ratio (Day 10/Day 1)|2.012|||||TWO_SIDED|90.0|1.632|2.481||||||Analysis for TAK 272F||2.481|1.632|
72490278|NCT02370615|144508276|SUPERIORITY_OR_OTHER||Geometric Mean Ratio (Day 10/Day 1)|0.089|||||TWO_SIDED|90.0|0.064|0.123||||||Analysis for TAK 272-M-I||0.123|0.064|
72490279|NCT02370615|144508277|SUPERIORITY_OR_OTHER||Geometric Mean Ratio (Day 10/Day 1)|4.888|||||TWO_SIDED|90.0|4.137|5.777||||||Analysis for TAK 272F||5.777|4.137|
72490280|NCT02370615|144508278|SUPERIORITY_OR_OTHER||Geometric Mean Ratio (Day 10/Day 1)|4.702|||||TWO_SIDED|90.0|3.969|5.569||||||Analysis for TAK 272F||5.569|3.969|
72490281|NCT02370615|144508278|SUPERIORITY_OR_OTHER||Geometric Mean Ratio (Day 10/Day 1)|0.023|||||TWO_SIDED|90.0|0.012|0.045||||||Analysis for TAK 272-M-I||0.045|0.012|
72490282|NCT02370615|144508280|SUPERIORITY_OR_OTHER||Geometric Mean Ratio (Day 7/Day 1)|1.349|||||TWO_SIDED|90.0|1.117|1.628||||||||1.628|1.117|
72490283|NCT02370615|144508281|SUPERIORITY_OR_OTHER||Geometric Mean Ratio (Day 7/Day 1)|1.02|||||TWO_SIDED|90.0|0.919|1.131||||||||1.131|0.919|
72490284|NCT02370615|144508282|SUPERIORITY_OR_OTHER||Geometric Mean Ratio (Day 7/Day 1)|1.155|||||TWO_SIDED|90.0|1.035|1.289||||||||1.289|1.035|
72490285|NCT02370615|144508284|SUPERIORITY_OR_OTHER||Geometric Mean Ratio (Day 7/Day 1)|1.235|||||TWO_SIDED|90.0|1.1|1.387||||||Analysis for Midazolam||1.387|1.100|
72490286|NCT02370615|144508284|SUPERIORITY_OR_OTHER||Geometric Mean Ratio (Day 7/Day 1)|0.887|||||TWO_SIDED|90.0|0.781|1.008||||||Analysis for 1'Hydroxymidazolam||1.008|0.781|
72490287|NCT02370615|144508285|SUPERIORITY_OR_OTHER||Geometric Mean Ratio (Day 7/Day 1)|1.422|||||TWO_SIDED|90.0|1.29|1.568||||||Analysis for Midazolam||1.568|1.290|
72490288|NCT02370615|144508285|SUPERIORITY_OR_OTHER||Geometric Mean Ratio (Day 7/Day 1)|1.081|||||TWO_SIDED|90.0|1.008|1.16||||||Analysis for 1'Hydroxymidazolam||1.160|1.008|
72490289|NCT02370615|144508286|SUPERIORITY_OR_OTHER||Geometric Mean Ratio (Day 7/Day 1)|1.425|||||TWO_SIDED|90.0|1.291|1.574||||||Analysis for Midazolam||1.574|1.291|
72490290|NCT02370615|144508286|SUPERIORITY_OR_OTHER||Geometric Mean Ratio (Day 7/Day 1)|1.061|||||TWO_SIDED|90.0|0.986|1.143||||||Analysis for 1'Hydroxymidazolam||1.143|0.986|
72490291|NCT01136655|144508295|SUPERIORITY_OR_OTHER||LS mean difference|0.114|STANDARD_ERROR_OF_MEAN|0.014|<|0.0001|TWO_SIDED|95.0|0.087|0.142|||ANCOVA|LOCF was performed if missing data were post last non-missing post-baseline assessment||Factors in the ANCOVA model included: patient, visit, treatment, and the covariate pre-dose FEV1 from each visit.||0.142|0.087|<0.0001
72490292|NCT01136655|144508295|SUPERIORITY_OR_OTHER||LS mean difference|0.105|STANDARD_ERROR_OF_MEAN|0.014|<|0.0001|TWO_SIDED|95.0|0.078|0.133|||ANCOVA|LOCF was performed if missing data were post last non-missing post-baseline assessment.||Factors in the ANCOVA model included: patient, visit, treatment, and the covariate pre-dose FEV1 from each visit.||0.133|0.078|<0.0001
72490293|NCT01136655|144508295|SUPERIORITY_OR_OTHER||LS mean difference|0.058|STANDARD_ERROR_OF_MEAN|0.0141||0.0001|TWO_SIDED|95.0|0.03|0.085|||ANCOVA|LOCF was performed if missing data were post last non-missing post-baseline assessment.||Factors in the ANCOVA model included: patient, visit, treatment, and the covariate pre-dose FEV1 from each visit.||0.085|0.030|0.0001
72490294|NCT01136655|144508295|SUPERIORITY_OR_OTHER||LS mean difference|-0.009|STANDARD_ERROR_OF_MEAN|0.0139||0.5223|TWO_SIDED|95.0|-0.036|0.018|||ANCOVA|LOCF was performed if missing data were post last non-missing post-baseline assessment.||Factors in the ANCOVA model included: patient, visit, treatment, and the covariate pre-dose FEV1 from each visit.||0.018|-0.036|0.5223
72490295|NCT01136655|144508295|SUPERIORITY_OR_OTHER||LS mean difference|-0.057|STANDARD_ERROR_OF_MEAN|0.0139||0.0001|TWO_SIDED|95.0|-0.084|-0.029|||ANCOVA|LOCF was performed if missing data were post last non-missing post-baseline assessment.||Factors in the ANCOVA model included: patient, visit, treatment, and the covariate pre-dose FEV1 from each visit.||-0.029|-0.084|0.0001
72404498|NCT00811577|144316214|SUPERIORITY_OR_OTHER|||||||0.87||95.0||||For this early phase study, multiple comparisons adjustments were not used.|Wilcoxon (signed rank)|||Statistical analysis included line plots of paired differences vs. time, univariate p-values from Wilcoxon signed rank tests, and repeated measures regression models in SAS/STAT PROC GENMOD.||||0.87
72404499|NCT00811577|144316214|SUPERIORITY_OR_OTHER|||||||0.15||95.0||||For this early phase study, multiple comparisons adjustments were not used.|Wilcoxon (signed rank)|||Statistical analysis included line plots of paired differences vs. time, univariate p-values from Wilcoxon signed rank tests, and repeated measures regression models in SAS/STAT PROC GENMOD.||||0.15
72404500|NCT00811577|144316214|SUPERIORITY_OR_OTHER|||||||0.77||95.0||||For this early phase study, multiple comparisons adjustments were not used.|Wilcoxon (signed rank)|||Statistical analysis included line plots of paired differences vs. time, univariate p-values from Wilcoxon signed rank tests, and repeated measures regression models in SAS/STAT PROC GENMOD.||||0.77
72404501|NCT00811577|144316214|SUPERIORITY_OR_OTHER|||||||0.75||95.0||||For this early phase study, multiple comparisons adjustments were not used.|Wilcoxon (signed rank)|||Statistical analysis included line plots of paired differences vs. time, univariate p-values from Wilcoxon signed rank tests, and repeated measures regression models in SAS/STAT PROC GENMOD.||||0.75
72404502|NCT00811577|144316214|SUPERIORITY_OR_OTHER|||||||0.05||95.0||||For this early phase study, multiple comparisons adjustments were not used.|Wilcoxon (signed rank)|||Statistical analysis included line plots of paired differences vs. time, univariate p-values from Wilcoxon signed rank tests, and repeated measures regression models in SAS/STAT PROC GENMOD.||||0.050
72404503|NCT00811577|144316214|SUPERIORITY_OR_OTHER|||||||0.83||95.0||||For this early phase study, multiple comparisons adjustments were not used.|Wilcoxon (signed rank)|||Statistical analysis included line plots of paired differences vs. time, univariate p-values from Wilcoxon signed rank tests, and repeated measures regression models in SAS/STAT PROC GENMOD.||||0.83
72516559|NCT04847141|144564265|SUPERIORITY||Difference in Percentage|1.9||||0.6463|TWO_SIDED|95.0|-6.5|10.3||p-value was calculated using Chi-square test with 5% level of significance to test the null hypothesis of no difference in the percentage of participants who had a negative test result between C19-IG 20% 2 g dose group and placebo.|Chi-squared||95% CI for percentage difference between C19-IG 20% 2 g dose group and placebo was calculated using the exact unconditional method.|Day 29||10.3|-6.5|0.6463
72404504|NCT00811577|144316214|SUPERIORITY_OR_OTHER|||||||0.37||95.0||||For this early phase study, multiple comparisons adjustments were not used.|Wilcoxon (signed rank)|||Statistical analysis included line plots of paired differences vs. time, univariate p-values from Wilcoxon signed rank tests, and repeated measures regression models in SAS/STAT PROC GENMOD.||||0.37
72404505|NCT00811577|144316214|SUPERIORITY_OR_OTHER|||||||0.43||95.0||||For this early phase study, multiple comparisons adjustments were not used.|Wilcoxon (signed rank)|||Statistical analysis included line plots of paired differences vs. time, univariate p-values from Wilcoxon signed rank tests, and repeated measures regression models in SAS/STAT PROC GENMOD.||||0.43
72404506|NCT00811577|144316215|SUPERIORITY_OR_OTHER|||||||0.16||95.0||||For this early phase study, multiple comparisons adjustments were not used.|Wilcoxon (signed rank)|||Statistical analysis included line plots of paired differences vs. time, univariate p-values from Wilcoxon signed rank tests, and repeated measures regression models in SAS/STAT PROC GENMOD.||||0.16
72404507|NCT00811577|144316215|SUPERIORITY_OR_OTHER|||||||0.14||95.0||||For this early phase study, multiple comparisons adjustments were not used.|Wilcoxon (signed rank)|||Statistical analysis included line plots of paired differences vs. time, univariate p-values from Wilcoxon signed rank tests, and repeated measures regression models in SAS/STAT PROC GENMOD.||||0.14
72404508|NCT00811577|144316215|SUPERIORITY_OR_OTHER|||||||0.69||95.0||||For this early phase study, multiple comparisons adjustments were not used.|Wilcoxon (signed rank)|||Statistical analysis included line plots of paired differences vs. time, univariate p-values from Wilcoxon signed rank tests, and repeated measures regression models in SAS/STAT PROC GENMOD.||||0.69
72404509|NCT00811577|144316215|SUPERIORITY_OR_OTHER|||||||0.89||95.0||||For this early phase study, multiple comparisons adjustments were not used.|Wilcoxon (signed rank)|||Statistical analysis included line plots of paired differences vs. time, univariate p-values from Wilcoxon signed rank tests, and repeated measures regression models in SAS/STAT PROC GENMOD.||||0.89
72404510|NCT00811577|144316215|SUPERIORITY_OR_OTHER|||||||0.3||95.0||||For this early phase study, multiple comparisons adjustments were not used.|Wilcoxon (signed rank)|||Statistical analysis included line plots of paired differences vs. time, univariate p-values from Wilcoxon signed rank tests, and repeated measures regression models in SAS/STAT PROC GENMOD.||||0.30
72404511|NCT00811577|144316215|SUPERIORITY_OR_OTHER|||||||0.46||95.0||||For this early phase study, multiple comparisons adjustments were not used.|Wilcoxon (signed rank)|||Statistical analysis included line plots of paired differences vs. time, univariate p-values from Wilcoxon signed rank tests, and repeated measures regression models in SAS/STAT PROC GENMOD.||||0.46
72490296|NCT01136655|144508295|SUPERIORITY_OR_OTHER||LS mean difference|-0.048|STANDARD_ERROR_OF_MEAN|0.0138||0.0007|TWO_SIDED|95.0|-0.075|-0.02|||ANCOVA|LOCF was performed if missing data were post last non-missing post-baseline assessment.||Factors in the ANCOVA model included: patient, visit, treatment, and the covariate pre-dose FEV1 from each visit.||-0.020|-0.075|0.0007
72490297|NCT01136655|144508295|SUPERIORITY_OR_OTHER||LS mean difference|-0.114|STANDARD_ERROR_OF_MEAN|0.0141|<|0.0001|TWO_SIDED|95.0|-0.142|-0.086|||ANCOVA|LOCF was performed if missing data were post last non-missing post-baseline assessment.||Factors in the ANCOVA model included: patient, visit, treatment, and the covariate pre-dose FEV1 from each visit.||-0.086|-0.142|<0.0001
72490298|NCT01136655|144508295|SUPERIORITY_OR_OTHER||LS mean difference|-0.056|STANDARD_ERROR_OF_MEAN|0.0141||0.0001|TWO_SIDED|95.0|-0.084|-0.028|||ANCOVA|LOCF was performed if missing data were post last non-missing post-baseline assessment.||Factors in the ANCOVA model included: patient, visit, treatment, and the covariate pre-dose FEV1 from each visit.||-0.028|-0.084|0.0001
72490299|NCT01136655|144508295|SUPERIORITY_OR_OTHER||LS mean difference|-0.009|STANDARD_ERROR_OF_MEAN|0.0141||0.5394|TWO_SIDED|95.0|-0.036|0.019|||ANCOVA|LOCF was performed if missing data were post last non-missing post-baseline assessment.||Factors in the ANCOVA model included: patient, visit, treatment, and the covariate pre-dose FEV1 from each visit.||0.019|-0.036|0.5394
72404512|NCT00811577|144316216|SUPERIORITY_OR_OTHER|||||||0.086||95.0||||For this early phase study, multiple comparisons adjustments were not used.|Wilcoxon (signed rank)|||Agreement between the two rater evaluations was assessed by tabulating the difference of the two ratings. Statistical methods for paired data were used to compare the two dosages of AZX100 to placebo.||||0.086
72624397|NCT02507934|144778678|SUPERIORITY||Mean Difference (Final Values)|7.95||||0.0111|TWO_SIDED|95.0|1.93|13.97||For each parameter, for each eye, an ANOVA model for repeated measures has been used by including each available timepoint. The estimated mean difference between treatments (Vismed-Lubricin) over time has been reported and tested.|repeated measures ANOVA|||Analysis of variance for repeated measures on Photophobia - Right eye||13.97|1.93|0.0111
72624398|NCT02507934|144778678|SUPERIORITY||Mean Difference (Final Values)|31.67||||0.0448|TWO_SIDED|95.0|0.78|62.56||For each parameter, for each eye, an ANOVA model for repeated measures has been used by including each available timepoint. The estimated mean difference between treatments (Vismed-Lubricin) over time has been reported and tested.|repeated measures ANOVA|||Analysis of variance for repeated measures on Total score ocular tolerability - Left eye||62.56|0.78|0.0448
72404513|NCT00811577|144316216|SUPERIORITY_OR_OTHER|||||||0.66||95.0||||For this early phase study, multiple comparisons adjustments were not used.|Wilcoxon (signed rank)|||Agreement between the two rater evaluations was assessed by tabulating the difference of the two ratings. Statistical methods for paired data were used to compare the two dosages of AZX100 to placebo.||||0.66
72404514|NCT00811577|144316216|SUPERIORITY_OR_OTHER|||||||0.069||95.0||||For this early phase study, multiple comparisons adjustments were not used.|Wilcoxon (signed rank)|||Agreement between the two rater evaluations was assessed by tabulating the difference of the two ratings. Statistical methods for paired data were used to compare the two dosages of AZX100 to placebo.||||0.069
72404515|NCT00811577|144316216|SUPERIORITY_OR_OTHER|||||||0.68||95.0||||For this early phase study, multiple comparisons adjustments were not used.|Wilcoxon (signed rank)|||Agreement between the two rater evaluations was assessed by tabulating the difference of the two ratings. Statistical methods for paired data were used to compare the two dosages of AZX100 to placebo.||||0.68
72404516|NCT00811577|144316216|SUPERIORITY_OR_OTHER|||||||0.095||95.0||||For this early phase study, multiple comparisons adjustments were not used.|Wilcoxon (signed rank)|||Agreement between the two rater evaluations was assessed by tabulating the difference of the two ratings. Statistical methods for paired data were used to compare the two dosages of AZX100 to placebo.||||0.095
72404517|NCT00811577|144316216|SUPERIORITY_OR_OTHER|||||||0.62||95.0||||For this early phase study, multiple comparisons adjustments were not used.|Wilcoxon (signed rank)|||Agreement between the two rater evaluations was assessed by tabulating the difference of the two ratings. Statistical methods for paired data were used to compare the two dosages of AZX100 to placebo.||||0.62
72516560|NCT04847141|144564266|SUPERIORITY|||||||0.9033|||||||Log Rank|||||||0.9033
72516561|NCT04847141|144564266|SUPERIORITY|||||||0.5456|||||||Log Rank|||||||0.5456
72516562|NCT04847141|144564267|SUPERIORITY||Difference in Percentage|0.79||||0.6311|TWO_SIDED|95.0|-2.9|4.6||p-value was calculated using Chi-square test with 5% level of significance to test the null hypothesis of no difference in the percentage of participants who required oxygen supplementation between C19-IG 20% 1 g dose group and placebo.|Chi-squared||95% CI for percentage difference between each of 1 g C19-IG 20% dose group and placebo was calculated using the exact unconditional method.|||4.6|-2.9|0.6311
72516563|NCT04847141|144564267|SUPERIORITY||Difference in Percentage|2.6||||0.1441|TWO_SIDED|95.0|-1.2|7.3||p-value was calculated using Chi-square test with 5% level of significance to test the null hypothesis of no difference in the percentage of participants who required oxygen supplementation between C19-IG 20% 2 g dose group and placebo.|Chi-squared||95% CI for percentage difference between each of 2 g C19-IG 20% dose group and placebo was calculated using the exact unconditional method.|||7.3|-1.2|0.1441
72624399|NCT02507934|144778678|SUPERIORITY||Mean Difference (Final Values)|26.36||||0.0834|TWO_SIDED|95.0|-3.66|56.37||For each parameter, for each eye, an ANOVA model for repeated measures has been used by including each available timepoint. The estimated mean difference between treatments (Vismed-Lubricin) over time has been reported and tested.|repeated measures ANOVA|||Analysis of variance for repeated measures on Total score ocular tolerability - Right eye||56.37|-3.66|0.0834
72624400|NCT02507934|144778680|SUPERIORITY||Mean Difference (Final Values)|0.21||||0.2317|TWO_SIDED|95.0|-0.14|0.57|||Student t-test for unpaired data|||T-test on changes from baseline on corneal fluorescein surface staining - Left eye - Day 7 ±1||0.57|-0.14|0.2317
72624401|NCT02507934|144778680|SUPERIORITY||Mean Difference (Final Values)|-0.14||||0.6017|TWO_SIDED|95.0|-0.7|0.41|||Student t-test for unpaired data|||T-test on changes from baseline on corneal fluorescein surface staining - Right eye - Day 7 ±1||0.41|-0.70|0.6017
72516564|NCT04847141|144564268|SUPERIORITY||LS Mean (LSM) Difference|0.02||||0.8555|TWO_SIDED|95.0|-0.23|0.27|||ANCOVA||95% CI for difference in LSM between 1 g C19-IG 20% \& placebo was calculated using an ANCOVA model,with number of days on oxygen as dependent variable \& treatment group as fixed effect,adjusting for baseline characteristics(including age \& gender).|||0.27|-0.23|0.8555
72624402|NCT02507934|144778680|SUPERIORITY||Mean Difference (Final Values)|0.74||||0.0232|TWO_SIDED|95.0|0.11|1.36|||Student t-test for unpaired data|||T-test on changes from baseline on corneal fluorescein surface staining - Left eye - Day 14 ±1||1.36|0.11|0.0232
72490300|NCT01136655|144508295|SUPERIORITY_OR_OTHER||LS mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.014||0.9863|TWO_SIDED|95.0|-0.027|0.028|||ANCOVA|LOCF was performed if missing data were post last non-missing post-baseline assessment.||Factors in the ANCOVA model included: patient, visit, treatment, and the covariate pre-dose FEV1 from each visit.||0.028|-0.027|0.9863
72490301|NCT01136655|144508296|SUPERIORITY_OR_OTHER||LS mean difference|0.105|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.056|0.155|||ANCOVA|LOCF was performed if missing data were post last non-missing post-baseline assessment.||Factors in the ANCOVA model included: patient, visit, treatment, and the covariate pre-dose FEV1 from each visit.||0.155|0.056|<0.0001
72516565|NCT04847141|144564268|SUPERIORITY||LS Mean Difference|0.03||||0.8108|TWO_SIDED|95.0|-0.22|0.28|||ANCOVA||95% CI for difference in LSM between 2 g C19-IG 20% \& placebo was calculated using an ANCOVA model,with number of days on oxygen as dependent variable \& treatment group as fixed effect,adjusting for baseline characteristics(including age \& gender).|||0.28|-0.22|0.8108
72516566|NCT04847141|144564270|SUPERIORITY||LS Mean Difference|0.03||||0.0692|TWO_SIDED|95.0|0.0|0.07||p-value was calculated using restricted maximum likelihood with the Kenward-Roger method.|Kenward-Roger||95% CI for difference in LS Mean between C19-IG 20% 1 g dose group and placebo was calculated using restricted maximum likelihood with the Kenward-Roger method for calculating the denominator degrees of freedom.|Day 7||0.07|-0.00|0.0692
72516567|NCT04847141|144564270|SUPERIORITY||LS Mean Difference|0.01||||0.4956|TWO_SIDED|95.0|-0.02|0.05||p-value was calculated using restricted maximum likelihood with the Kenward-Roger method.|Kenward-Roger||95% CI for difference in LS Mean between C19-IG 20% 2 g dose group and placebo was calculated using restricted maximum likelihood with the Kenward-Roger method for calculating the denominator degrees of freedom.|Day 7||0.05|-0.02|0.4956
72516568|NCT04847141|144564270|SUPERIORITY||LS Mean Difference|-0.05||||0.22|TWO_SIDED|95.0|-0.13|0.03||p-value was calculated using restricted maximum likelihood with the Kenward-Roger method.|Kenward-Roger||95% CI for difference in LS Mean between C19-IG 20% 1 g dose group and placebo was calculated using restricted maximum likelihood with the Kenward-Roger method for calculating the denominator degrees of freedom.|Day 14||0.03|-0.13|0.2200
72516569|NCT04847141|144564270|SUPERIORITY||LS Mean Difference|-0.07||||0.0906|TWO_SIDED|95.0|-0.14|0.01||p-value was calculated using restricted maximum likelihood with the Kenward-Roger method.|Kenward-Roger||95% CI for difference in LS Mean between C19-IG 20% 2 g dose group and placebo was calculated using restricted maximum likelihood with the Kenward-Roger method for calculating the denominator degrees of freedom.|Day 14||0.01|-0.14|0.0906
72516570|NCT04847141|144564270|SUPERIORITY||LS Mean Difference|-0.04||||0.0439|TWO_SIDED|95.0|-0.07|0.0||p-value was calculated using restricted maximum likelihood with the Kenward-Roger method.|Kenward-Roger||95% CI for difference in LS Mean between C19-IG 20% 1 g dose group and placebo was calculated using restricted maximum likelihood with the Kenward-Roger method for calculating the denominator degrees of freedom.|Day 29||-0.00|-0.07|0.0439
72516571|NCT04847141|144564270|SUPERIORITY||LS Mean Difference|-0.01||||0.4128|TWO_SIDED|95.0|-0.05|0.02||p-value was calculated using restricted maximum likelihood with the Kenward-Roger method.|Kenward-Roger||95% CI for difference in LS Mean between C19-IG 20% 2 g dose group and placebo was calculated using restricted maximum likelihood with the Kenward-Roger method for calculating the denominator degrees of freedom.|Day 29||0.02|-0.05|0.4128
72568653|NCT04168190|144668507|NON_INFERIORITY|Non-inferiority can be concluded if the lower bound of the 95% CI for the estimated GMC ratio (V116/PPSV23) is \>0.5 (1-sided p-value \<0.025).|GMC Ratio|1.23|||<|0.001|TWO_SIDED|95.0|0.99|1.52|||P-value is estimated from a cLDA model.||Phase 2: V116/Phase 2: Pneumovax™23|Serotype 7F. Geometric mean concentration (GMC) ratio, 95% confidence interval (CI), and p-value are estimated from a constrained longitudinal data analysis (cLDA) model.||1.52|0.99|<0.001
72568654|NCT04168190|144668507|NON_INFERIORITY|Non-inferiority can be concluded if the lower bound of the 95% CI for the estimated GMC ratio (V116/PPSV23) is \>0.5 (1-sided p-value \<0.025).|GMC Ratio|1.24|||<|0.001|TWO_SIDED|95.0|1.02|1.52|||P-value is estimated from a cLDA model.||Phase 2: V116/Phase 2: Pneumovax™23|Serotype 19A. Geometric mean concentration (GMC) ratio, 95% confidence interval (CI), and p-value are estimated from a constrained longitudinal data analysis (cLDA) model.||1.52|1.02|<0.001
72490302|NCT01136655|144508296|SUPERIORITY_OR_OTHER||LS mean difference|0.066|STANDARD_ERROR_OF_MEAN|0.0252||0.0092|TWO_SIDED|95.0|0.017|0.116|||ANCOVA|LOCF was performed if missing data were post last non-missing post-baseline assessment.||Factors in the ANCOVA model included: patient, visit, treatment, and the covariate pre-dose FEV1 from each visit.||0.116|0.017|0.0092
72516572|NCT04847141|144564272|SUPERIORITY||LS Mean Difference|-0.01||||0.9713|TWO_SIDED|95.0|-0.28|0.27||p-value was calculated using restricted maximum likelihood with the Kenward-Roger method.|Kenward-Roger||95% CI for difference in LS Mean between C19-IG 20% 1 g dose group and placebo was calculated using restricted maximum likelihood with the Kenward-Roger method for calculating the denominator degrees of freedom.|Day 7||0.27|-0.28|0.9713
72516573|NCT04847141|144564272|SUPERIORITY||LS Mean Difference|0.07||||0.5985|TWO_SIDED|95.0|-0.2|0.35||p-value was calculated using restricted maximum likelihood with the Kenward-Roger method.|Kenward-Roger||95% CI for difference in LS Mean between C19-IG 20% 2 g dose group and placebo was calculated using restricted maximum likelihood with the Kenward-Roger method for calculating the denominator degrees of freedom.|Day 7||0.35|-0.20|0.5985
72516574|NCT04847141|144564272|SUPERIORITY||LS Mean Difference|0.01||||0.9209|TWO_SIDED|95.0|-0.25|0.28||p-value was calculated using restricted maximum likelihood with the Kenward-Roger method.|Kenward-Roger||95% CI for difference in LS Mean between C19-IG 20% 1 g dose group and placebo was calculated using restricted maximum likelihood with the Kenward-Roger method for calculating the denominator degrees of freedom.|Day 14||0.28|-0.25|0.9209
72624403|NCT02507934|144778680|SUPERIORITY||Mean Difference (Final Values)|0.6||||0.0398|TWO_SIDED|95.0|0.03|1.17|||Student t-test for unpaired data|||T-test on changes from baseline on corneal fluorescein surface staining - Right eye - Day 14 ±1||1.17|0.03|0.0398
72624404|NCT02507934|144778680|SUPERIORITY||Mean Difference (Final Values)|1.05||||0.0038|TWO_SIDED|95.0|0.36|1.74|||Student t-test for unpaired data|||T-test on changes from baseline on corneal fluorescein surface staining - Left eye - Day 21 ±1||1.74|0.36|0.0038
72624405|NCT02507934|144778680|SUPERIORITY||Mean Difference (Final Values)|0.75||||0.0135|TWO_SIDED|95.0|0.17|1.33|||Student t-test for unpaired data|||T-test on changes from baseline on corneal fluorescein surface staining - right eye||1.33|0.17|0.0135
72404518|NCT00811577|144316217|SUPERIORITY_OR_OTHER|||||||0.44||95.0|||||Wilcoxon (signed rank)|||A regression analysis was run to compare alpha-SMA between 3 mg and 10 mg AZX100 and placebo, adjusted for the subject's gender and age. GEE regression in SAS/STAT PROC GENMOD was used because it properly handled the correlations among the three observations for each subject.||||0.44
72404519|NCT00811577|144316217|SUPERIORITY_OR_OTHER|||||||0.41||95.0|||||Wilcoxon (signed rank)|||A regression analysis was run to compare alpha-SMA between 3 mg and 10 mg AZX100 and placebo, adjusted for the subject's gender and age. GEE regression in SAS/STAT PROC GENMOD was used because it properly handled the correlations among the three observations for each subject.||||0.41
72404520|NCT02442778|144316222|SUPERIORITY||Least Squares (LS) Mean Difference|0.4||||0.789|TWO_SIDED|95.0|-2.7|3.5||MMRM included fixed effect treatment,visit,treatment-by-visit,baseline,baseline-by-visit,baseline Neuropsychiatric Inventory Agitation/Aggression(NPI AA)(≤6 vs. \>6),falls risk assessment,baseline concomitant use of antipsychotic medications,cohorts.|MMRM|||||3.5|-2.7|0.789
72404521|NCT02442778|144316222|SUPERIORITY||LS Mean Difference|-2.0||||0.2|TWO_SIDED|95.0|-5.0|1.0||MMRM included fixed effect treatment, visit, treatment-by-visit, baseline, baseline-by-visit, baseline NPI AA (≤ 6 vs. \> 6), risk assessment for falls, baseline concomitant use of antipsychotic medications and cohorts.|MMRM|||||1.0|-5.0|0.200
72490303|NCT01136655|144508296|SUPERIORITY_OR_OTHER||LS mean difference|0.015|STANDARD_ERROR_OF_MEAN|0.0252||0.5509|TWO_SIDED|95.0|-0.035|0.065|||ANCOVA|LOCF was performed if missing data were post last non-missing post-baseline assessment.||Factors in the ANCOVA model included: patient, visit, treatment, and the covariate pre-dose FEV1 from each visit.||0.065|-0.035|0.5509
72404522|NCT02442778|144316223|SUPERIORITY||LS Mean Difference|0.1||||0.484|TWO_SIDED|95.0|-0.2|0.4||MMRM included fixed effect treatment, visit, treatment-by-visit, baseline, baseline-by-visit, baseline NPI AA (≤ 6 vs. \> 6), risk assessment for falls, baseline concomitant use of antipsychotic medications and cohorts.|MMRM|||||0.4|-0.2|0.484
72404523|NCT02442778|144316223|SUPERIORITY||LS Mean Difference|-0.1||||0.704|TWO_SIDED|95.0|-0.3|0.2||MMRM included fixed effect treatment, visit, treatment-by-visit, baseline, baseline-by-visit, baseline NPI AA (≤ 6 vs. \> 6), risk assessment for falls, baseline concomitant use of antipsychotic medications and cohorts.|MMRM|||||0.2|-0.3|0.704
72404524|NCT02442778|144316224|SUPERIORITY||LS Mean Difference|-0.3||||0.416|TWO_SIDED|95.0|-0.9|0.4||MMRM included fixed effect treatment, visit, treatment-by-visit, baseline, baseline-by-visit, baseline NPI AA (≤ 6 vs. \> 6), risk assessment for falls, baseline concomitant use of antipsychotic medications and cohorts.|MMRM|||||0.4|-0.9|0.416
72404525|NCT02442778|144316224|SUPERIORITY||LS Mean Difference|-0.6||||0.066|TWO_SIDED|95.0|-1.3|0.0||MMRM included fixed effect treatment, visit, treatment-by-visit, baseline, baseline-by-visit, baseline NPI AA (≤ 6 vs. \> 6), risk assessment for falls, baseline concomitant use of antipsychotic medications and cohorts.|MMRM|||||0.0|-1.3|0.066
72490304|NCT01136655|144508296|SUPERIORITY_OR_OTHER||LS mean difference|-0.039|STANDARD_ERROR_OF_MEAN|0.0249||0.1163|TWO_SIDED|95.0|-0.088|0.01|||ANCOVA|LOCF was performed if missing data were post last non-missing post-baseline assessment.||Factors in the ANCOVA model included: patient, visit, treatment, and the covariate pre-dose FEV1 from each visit.||0.010|-0.088|0.1163
72490305|NCT01136655|144508296|SUPERIORITY_OR_OTHER||LS mean difference|-0.09|STANDARD_ERROR_OF_MEAN|0.025||0.0004|TWO_SIDED|95.0|-0.14|-0.041|||ANCOVA|LOCF was performed if missing data were post last non-missing post-baseline assessment.||Factors in the ANCOVA model included: patient, visit, treatment, and the covariate pre-dose FEV1 from each visit.||-0.041|-0.140|0.0004
72404526|NCT02442778|144316225|SUPERIORITY||LS Mean Difference|-0.2||||0.249|TWO_SIDED|95.0|-0.5|0.1||MMRM included fixed effect treatment, visit, treatment-by-visit, baseline, baseline-by-visit, baseline NPI AA (≤ 6 vs. \> 6), risk assessment for falls, baseline concomitant use of antipsychotic medications and cohorts.|MMRM|||||0.1|-0.5|0.249
72516575|NCT04847141|144564272|SUPERIORITY||LS Mean Difference|-0.01||||0.9181|TWO_SIDED|95.0|-0.28|0.25||p-value was calculated using restricted maximum likelihood with the Kenward-Roger method.|Kenward-Roger||95% CI for difference in LS Mean between C19-IG 20% 2 g dose group and placebo was calculated using restricted maximum likelihood with the Kenward-Roger method for calculating the denominator degrees of freedom.|Day 14||0.25|-0.28|0.9181
72516576|NCT04847141|144564272|SUPERIORITY||LS Mean Difference|0.15||||0.2443|TWO_SIDED|95.0|-0.11|0.41||p-value was calculated using restricted maximum likelihood with the Kenward-Roger method.|Kenward-Roger||95% CI for difference in LS Mean between C19-IG 20% 1 g dose group and placebo was calculated using restricted maximum likelihood with the Kenward-Roger method for calculating the denominator degrees of freedom.|Day 29||0.41|-0.11|0.2443
72490306|NCT01136655|144508296|SUPERIORITY_OR_OTHER||LS mean difference|-0.051|STANDARD_ERROR_OF_MEAN|0.0247||0.04|TWO_SIDED|95.0|-0.1|-0.002|||ANCOVA|LOCF was performed if missing data were post last non-missing post-baseline assessment.||Factors in the ANCOVA model included: patient, visit, treatment, and the covariate pre-dose FEV1 from each visit.||-0.002|-0.100|0.0400
72490307|NCT01136655|144508296|SUPERIORITY_OR_OTHER||LS mean difference|-0.083|STANDARD_ERROR_OF_MEAN|0.0252||0.0011|TWO_SIDED|95.0|-0.133|-0.034|||ANCOVA|LOCF was performed if missing data were post last non-missing post-baseline assessment.||Factors in the ANCOVA model included: patient, visit, treatment, and the covariate pre-dose FEV1 from each visit.||-0.034|-0.133|0.0011
72516577|NCT04847141|144564272|SUPERIORITY||LS Mean Difference|0.13||||0.3233|TWO_SIDED|95.0|-0.13|0.39||p-value was calculated using restricted maximum likelihood with the Kenward-Roger method.|Kenward-Roger||95% CI for difference in LS Mean between C19-IG 20% 2 g dose group and placebo was calculated using restricted maximum likelihood with the Kenward-Roger method for calculating the denominator degrees of freedom.|Day 29||0.39|-0.13|0.3233
72516578|NCT04847141|144564273|SUPERIORITY||Difference in Percentage|3.0||||0.4676|TWO_SIDED|95.0|-5.3|11.5||p-value was calculated using Chi-square test with 5% level of significance to test the null hypothesis of no difference in the percentage of participants who required at least 1 COVID-19 related MAV between C19-IG 20% 1 g dose group and placebo.|Chi-squared||95% CI for percentage difference between C19-IG 20% 1 g dose group and placebo was calculated using the exact unconditional method.|||11.5|-5.3|0.4676
72404527|NCT02442778|144316225|SUPERIORITY||LS Mean Difference|-0.2||||0.199|TWO_SIDED|95.0|-0.5|0.1||MMRM included fixed effect treatment, visit, treatment-by-visit, baseline, baseline-by-visit, baseline NPI AA (≤ 6 vs. \> 6), risk assessment for falls, baseline concomitant use of antipsychotic medications and cohorts.|MMRM|||||0.1|-0.5|0.199
72490308|NCT01136655|144508296|SUPERIORITY_OR_OTHER||LS mean difference|-0.068|STANDARD_ERROR_OF_MEAN|0.0254||0.0077|TWO_SIDED|95.0|-0.118|-0.018|||ANCOVA|LOCF was performed if missing data were post last non-missing post-baseline assessment.||Factors in the ANCOVA model included: patient, visit, treatment, and the covariate pre-dose FEV1 from each visit.||-0.018|-0.118|0.0077
72490309|NCT01136655|144508296|SUPERIORITY_OR_OTHER||LS mean difference|-0.017|STANDARD_ERROR_OF_MEAN|0.0252||0.4957|TWO_SIDED|95.0|-0.067|0.033|||ANCOVA|LOCF was performed if missing data were post last non-missing post-baseline assessment.||Factors in the ANCOVA model included: patient, visit, treatment, and the covariate pre-dose FEV1 from each visit.||0.033|-0.067|0.4957
72490310|NCT01136655|144508296|SUPERIORITY_OR_OTHER||LS mean difference|0.022|STANDARD_ERROR_OF_MEAN|0.025||0.38|TWO_SIDED|95.0|-0.027|0.071|||ANCOVA|LOCF was performed if missing data were post last non-missing post-baseline assessment.||Factors in the ANCOVA model included: patient, visit, treatment, and the covariate pre-dose FEV1 from each visit.||0.071|-0.027|0.3800
72490311|NCT01136655|144508297|SUPERIORITY_OR_OTHER||LS mean difference|0.107|STANDARD_ERROR_OF_MEAN|0.017|<|0.0001|TWO_SIDED|95.0|0.073|0.14|||ANCOVA|||Factors in the Analysis of Covariance model included: patient, visit, treatment, and the covariate pre-dose FEV1 from each visit.||0.140|0.073|<0.0001
72490312|NCT01136655|144508297|SUPERIORITY_OR_OTHER||LS mean difference|0.112|STANDARD_ERROR_OF_MEAN|0.0171|<|0.0001|TWO_SIDED|95.0|0.078|0.146|||ANCOVA|||Factors in the Analysis of Covariance model included: patient, visit, treatment, and the covariate pre-dose FEV1 from each visit.||0.146|0.078|<0.0001
72490313|NCT01136655|144508297|SUPERIORITY_OR_OTHER||LS mean difference|0.057|STANDARD_ERROR_OF_MEAN|0.0172||0.0011|TWO_SIDED|95.0|0.023|0.09|||ANCOVA|||Factors in the Analysis of Covariance model included: patient, visit, treatment, and the covariate pre-dose FEV1 from each visit.||0.090|0.023|0.0011
72490314|NCT01136655|144508297|SUPERIORITY_OR_OTHER||LS mean difference|0.005|STANDARD_ERROR_OF_MEAN|0.0169||0.7589|TWO_SIDED|95.0|-0.028|0.039|||ANCOVA|||Factors in the Analysis of Covariance model included: patient, visit, treatment, and the covariate pre-dose FEV1 from each visit.||0.039|-0.028|0.7589
72490315|NCT01136655|144508297|SUPERIORITY_OR_OTHER||LS mean difference|-0.05|STANDARD_ERROR_OF_MEAN|0.017||0.0035|TWO_SIDED|95.0|-0.084|-0.017|||ANCOVA|||Factors in the Analysis of Covariance model included: patient, visit, treatment, and the covariate pre-dose FEV1 from each visit.||-0.017|-0.084|0.0035
72490316|NCT01136655|144508297|SUPERIORITY_OR_OTHER||LS mean difference|-0.055|STANDARD_ERROR_OF_MEAN|0.0168||0.0011|TWO_SIDED|95.0|-0.089|-0.022|||ANCOVA|||Factors in the Analysis of Covariance model included: patient, visit, treatment, and the covariate pre-dose FEV1 from each visit.||-0.022|-0.089|0.0011
72490317|NCT01136655|144508297|SUPERIORITY_OR_OTHER||LS mean difference|-0.115|STANDARD_ERROR_OF_MEAN|0.0171|<|0.0001|TWO_SIDED|95.0|-0.149|-0.081|||ANCOVA|||Factors in the Analysis of Covariance model included: patient, visit, treatment, and the covariate pre-dose FEV1 from each visit.||-0.081|-0.149|<0.0001
72490318|NCT01136655|144508297|SUPERIORITY_OR_OTHER||LS mean difference|-0.058|STANDARD_ERROR_OF_MEAN|0.0172||0.0008|TWO_SIDED|95.0|-0.092|-0.024|||ANCOVA|||Factors in the Analysis of Covariance model included: patient, visit, treatment, and the covariate pre-dose FEV1 from each visit.||-0.024|-0.092|0.0008
72490319|NCT01136655|144508297|SUPERIORITY_OR_OTHER||LS mean difference|-0.003|STANDARD_ERROR_OF_MEAN|0.0172||0.8582|TWO_SIDED|95.0|-0.037|0.031|||ANCOVA|||Factors in the Analysis of Covariance model included: patient, visit, treatment, and the covariate pre-dose FEV1 from each visit.||0.031|-0.037|0.8582
72490320|NCT01136655|144508297|SUPERIORITY_OR_OTHER||LS mean difference|-0.008|STANDARD_ERROR_OF_MEAN|0.017||0.6276|TWO_SIDED|95.0|-0.042|0.025|||ANCOVA|||Factors in the Analysis of Covariance model included: patient, visit, treatment, and the covariate pre-dose FEV1 from each visit.||0.025|-0.042|0.6276
72490321|NCT01136655|144508298|SUPERIORITY_OR_OTHER||LS mean difference|0.52|||<|0.0001|TWO_SIDED|95.0|0.393|0.7|||ANOVA|A shift log transformation was performed on the response variable in the ANOVA model, using log(response) \[log(response + 1) if response is 0\].||Factors in the ANOVA model included: patient, period and treatment.||0.700|0.393|<0.0001
72490322|NCT01136655|144508298|SUPERIORITY_OR_OTHER||LS mean difference|0.26|||<|0.0001|TWO_SIDED|95.0|0.194|0.347|||ANOVA|A shift log transformation was performed on the response variable in the ANOVA model, using log(response) \[log(response + 1) if response is 0\].||Factors in the ANOVA model included: patient, period and treatment.||0.347|0.194|<0.0001
72490323|NCT01136655|144508298|SUPERIORITY_OR_OTHER||LS mean difference|0.29|||<|0.0001|TWO_SIDED|95.0|0.214|0.396|||ANOVA|A shift log transformation was performed on the response variable in the ANOVA model, using log(response) \[log(response + 1) if response is 0\].||Factors in the ANOVA model included: patient, period and treatment.||0.396|0.214|<0.0001
72490324|NCT01136655|144508298|SUPERIORITY_OR_OTHER||LS mean difference|0.49|||<|0.0001|TWO_SIDED|95.0|0.371|0.659|||ANOVA|A shift log transformation was performed on the response variable in the ANOVA model, using log(response) \[log(response + 1) if response is 0\].||Factors in the ANOVA model included: patient, period and treatment.||0.659|0.371|<0.0001
72490325|NCT01136655|144508298|SUPERIORITY_OR_OTHER||LS mean difference|0.56||||0.0002|TWO_SIDED|95.0|0.409|0.755|||ANOVA|A shift log transformation was performed on the response variable in the ANOVA model, using log(response) \[log(response + 1) if response is 0\].||Factors in the ANOVA model included: patient, period and treatment.||0.755|0.409|0.0002
72490326|NCT01136655|144508298|SUPERIORITY_OR_OTHER||LS mean difference|1.12||||0.4512|TWO_SIDED|95.0|0.827|1.528|||ANOVA|A shift log transformation was performed on the response variable in the ANOVA model, using log(response) \[log(response + 1) if response is 0\].||Factors in the ANOVA model included: patient, period and treatment.||1.528|0.827|0.4512
72490327|NCT02831673|144508360|NON_INFERIORITY|Treatment with DTG+ 3TC was to be declared non-inferior to treatment with DTG+TDF/FTC if the lower end of a two-sided 95% confidence interval for the difference between the two groups in response rates at Week 48 greater than -10%.|Adjusted difference in proportion|-2.6|||||TWO_SIDED|95.0|-6.7|1.5|||||Difference in proportion was based on CMH stratified analysis adjusting for Baseline stratification factors: Plasma HIV-1 RNA (\<=versus \[vs.\]\>100,000 c/mL) and cluster of differentiation 4+ (CD4+) cell count (\<= vs. \>200 cells per cubic millimeter).|||1.5|-6.7|
72490328|NCT02831673|144508361|OTHER||Adjusted difference in proportion|-0.4|||||TWO_SIDED|95.0|-4.2|3.4|||||Difference in proportion was based on CMH stratified analysis adjusting for Baseline stratification factors: Plasma HIV-1 RNA (\<=vs.\>100,000 c/mL) and CD4+ cell count (\<= vs. \>200 cells per cubic millimeter).|||3.4|-4.2|
72624406|NCT02507934|144778681|SUPERIORITY||Mean Difference (Final Values)|0.59||||0.3442|TWO_SIDED|95.0|-0.66|1.83|||Student t-test for unpaired data|||T-test on changes from baseline on Schirmer's test type I strip wetting distance - Left eye - Day 7±1||1.83|-0.66|0.3442
72404528|NCT02442778|144316226|SUPERIORITY||LS Mean Difference|0.0||||0.975|TWO_SIDED|95.0|-0.7|0.7||MMRM included fixed effect treatment, visit, treatment-by-visit, baseline, baseline-by-visit, baseline NPI AA (≤ 6 vs. \> 6), risk assessment for falls, baseline concomitant use of antipsychotic medications and cohorts.|MMRM|||||0.7|-0.7|0.975
72404529|NCT02442778|144316226|SUPERIORITY||LS Mean Difference|-0.3||||0.334|TWO_SIDED|95.0|-1.0|0.3||MMRM included fixed effect treatment, visit, treatment-by-visit, baseline, baseline-by-visit, baseline NPI AA (≤ 6 vs. \> 6), risk assessment for falls, baseline concomitant use of antipsychotic medications and cohorts.|MMRM|||||0.3|-1.0|0.334
72490329|NCT02831673|144508362|OTHER||Adjusted difference in proportion|-4.9|||||TWO_SIDED|95.0|-9.8|0.0|||||Week 96. Difference in proportion was based on CMH stratified analysis adjusting for Baseline stratification factors: Plasma HIV-1 RNA (\<= vs. \>100,000 c/mL) and CD4+ cell count (\<= vs. \>200 cells/mm\^3).|||0.0|-9.8|
72490330|NCT02831673|144508363|OTHER||Adjusted difference in proportion|-3.6|||||TWO_SIDED|95.0|-9.4|2.1|||||Week 144. Difference in proportion was based on CMH stratified analysis adjusting for Baseline stratification factors: Plasma HIV-1 RNA (\<= vs. \>100,000 c/mL) and CD4+ cell count (\<= vs. \>200 cells/mm\^3).|||2.1|-9.4|
72624407|NCT02507934|144778681|SUPERIORITY||Mean Difference (Final Values)|-0.25||||0.772|TWO_SIDED|95.0|-1.99|1.49|||Student t-test for unpaired data|||T-test on changes from baseline on Schirmer's test type I strip wetting distance - Right eye - Day 7±1||1.49|-1.99|0.7720
72624408|NCT02507934|144778681|SUPERIORITY||Mean Difference (Final Values)|-0.03||||0.9725|TWO_SIDED|95.0|-1.49|1.44|||Student t-test for unpaired data|||T-test on changes from baseline on Schirmer's test type I strip wetting distance - Left eye - Day 14±1||1.44|-1.49|0.9725
72624409|NCT02507934|144778681|SUPERIORITY||Mean Difference (Final Values)|-1.36||||0.2111|TWO_SIDED|95.0|-3.54|0.81|||Student t-test for unpaired data|||T-test on changes from baseline on Schirmer's test type I strip wetting distance - Right eye - Day 14±1||0.81|-3.54|0.2111
72624410|NCT02507934|144778681|SUPERIORITY||Median Difference (Final Values)|-1.1||||0.2629|TWO_SIDED|90.0|-3.06|0.86|||Student t-test for unpaired data|||T-test on changes from baseline on Schirmer's test type I strip wetting distance - Left eye - Day 21±1||0.86|-3.06|0.2629
72624411|NCT02507934|144778681|SUPERIORITY||Mean Difference (Final Values)|-1.25||||0.2862|TWO_SIDED|95.0|-3.6|1.1|||Student t-test for unpaired data|||T-test on changes from baseline on Schirmer's test type I strip wetting distance - Right eye - 21±1||1.10|-3.60|0.2862
72624412|NCT02507934|144778682|SUPERIORITY||Mean Difference (Final Values)|11.24||||0.2075|TWO_SIDED|95.0|-6.66|29.14|||Student t-test for unpaired data|||T-test on changes from baseline in symptom assessment in dry eye - Frequency - Day 7±1||29.14|-6.66|0.2075
72624413|NCT02507934|144778682|SUPERIORITY||Mean Difference (Final Values)|18.16||||0.0435|TWO_SIDED|95.0|0.57|35.76|||Student t-test for unpaired data|||T-test on changes from baseline in symptom assessment in dry eye - Frequency - Day 14±1||35.76|0.57|0.0435
72624414|NCT02507934|144778682|SUPERIORITY||Mean Difference (Final Values)|23.58||||0.0133|TWO_SIDED|95.0|5.24|41.93|||Student t-test for unpaired data|||T-test on changes from baseline in symptom assessment in dry eye - Frequency - Day 21±1||41.93|5.24|0.0133
72624415|NCT02507934|144778683|SUPERIORITY||Mean Difference (Final Values)|4.36||||0.613|TWO_SIDED|95.0|-12.98|21.69|||Student t-test for unpaired data|||T-test on changes from baseline in symptom assessment in dry eye - Severity - Day 7±1||21.69|-12.98|0.6130
72624416|NCT02507934|144778683|SUPERIORITY||Mean Difference (Final Values)|12.7||||0.1047|TWO_SIDED|95.0|-2.78|28.18|||Student t-test for unpaired data|||T-test on changes from baseline in symptom assessment in dry eye - Severity - Day 14±1||28.18|-2.78|0.1047
72624417|NCT02507934|144778683|SUPERIORITY||Mean Difference (Final Values)|13.4||||0.1108|TWO_SIDED|95.0|-3.24|30.04|||Student t-test for unpaired data|||T-test on changes from baseline in symptom assessment in dry eye - Severity - Day 21±1||30.04|-3.24|0.1108
72624418|NCT02507934|144778684|SUPERIORITY||Mean Difference (Final Values)|0.21||||0.498|TWO_SIDED|95.0|-0.4|0.81|||Student t-test for unpaired data|||T-test on changes from baseline in Ocular Protection Index - Left eye - Day 7±1||0.81|-0.40|0.4980
72624419|NCT02507934|144778684|SUPERIORITY||Mean Difference (Final Values)|0.33||||0.1986|TWO_SIDED|95.0|-0.18|0.83|||Student t-test for unpaired data|||T-test on changes from baseline in Ocular Protection Index - Right eye - Day 7±1||0.83|-0.18|0.1986
72624420|NCT02507934|144778684|SUPERIORITY||Mean Difference (Final Values)|-0.26||||0.4067|TWO_SIDED|95.0|-0.9|0.37|||Student t-test for unpaired data|||T-test on changes from baseline in Ocular Protection Index - Left eye - Day 14±1||0.37|-0.90|0.4067
72624421|NCT02507934|144778684|SUPERIORITY||Mean Difference (Final Values)|-0.19||||0.5256|TWO_SIDED|95.0|-0.81|0.42|||Student t-test for unpaired data|||T-test on changes from baseline in Ocular Protection Index - Right eye - Day 14±1||0.42|-0.81|0.5256
72624422|NCT02507934|144778684|SUPERIORITY||Mean Difference (Final Values)|-0.47||||0.1471|TWO_SIDED|95.0|-1.12|0.17|||Student t-test for unpaired data|||T-test on changes from baseline in Ocular Protection Index - Left eye - Day 21±1||0.17|-1.12|0.1471
72624423|NCT02507934|144778684|SUPERIORITY||Mean Difference (Final Values)|-0.35||||0.2455|TWO_SIDED|95.0|-0.96|0.25|||Student t-test for unpaired data|||T-test on changes from baseline in Ocular Protection Index - Right eye - Day 21±1||0.25|-0.96|0.2455
72624424|NCT02507934|144778685|SUPERIORITY||Mean Difference (Final Values)|-0.56||||0.4233|TWO_SIDED|95.0|-1.98|0.85|||Student t-test for unpaired data|||T test p-value - Left eye - Day 7±1||0.85|-1.98|0.4233
72624425|NCT02507934|144778685|SUPERIORITY||Mean Difference (Final Values)|0.32||||0.6335|TWO_SIDED|95.0|-1.04|1.69|||Student t-test for unpaired data|||T test p-value - Right eye - Day 7±1||1.69|-1.04|0.6335
72624426|NCT02507934|144778685|SUPERIORITY||Mean Difference (Final Values)|-2.04||||0.0103|TWO_SIDED|95.0|-3.56|-0.51|||Student t-test for unpaired data|||T test p-value - Left eye - Day 14±1||-0.51|-3.56|0.0103
72624427|NCT02507934|144778685|SUPERIORITY||Mean Difference (Final Values)|-1.34||||0.1006|TWO_SIDED|95.0|-2.95|0.27|||Student t-test for unpaired data|||T test p-value - Right eye - Day 14±1||0.27|-2.95|0.1006
72624428|NCT02507934|144778685|SUPERIORITY||Mean Difference (Final Values)|-2.5||||0.0041|TWO_SIDED|95.0|-4.15|-0.85|||Student t-test for unpaired data|||T test p-value - Left eye - Day 21±1||-0.85|-4.15|0.0041
72624429|NCT02507934|144778685|SUPERIORITY||Mean Difference (Final Values)|-1.87||||0.0429|TWO_SIDED|95.0|-3.67|-0.06|||Student t-test for unpaired data|||T test p-value - Right eye - Day 21±1||-0.06|-3.67|0.0429
72404530|NCT02442778|144316227|SUPERIORITY||LS Mean Difference|-0.1||||0.934|TWO_SIDED|95.0|-2.4|2.2||MMRM included fixed effect treatment, visit, treatment-by-visit, baseline, baseline-by-visit, baseline NPI AA (≤ 6 vs. \> 6), risk assessment for falls, baseline concomitant use of antipsychotic medications and cohorts.|MMRM|||||2.2|-2.4|0.934
72404531|NCT02442778|144316227|SUPERIORITY||LS Mean Difference|1.1||||0.342|TWO_SIDED|95.0|-1.2|3.4||MMRM included fixed effect treatment, visit, treatment-by-visit, baseline, baseline-by-visit, baseline NPI AA (≤ 6 vs. \> 6), risk assessment for falls, baseline concomitant use of antipsychotic medications and cohorts.|MMRM|||||3.4|-1.2|0.342
72404532|NCT02442778|144316228|SUPERIORITY||LS Mean Difference|0.0||||0.888|TWO_SIDED|95.0|-0.7|0.6||MMRM included fixed effect treatment, visit, treatment-by-visit, baseline, baseline-by-visit, baseline NPI AA (≤ 6 vs. \> 6), risk assessment for falls, baseline concomitant use of antipsychotic medications and cohorts.|MMRM|||||0.6|-0.7|0.888
72404533|NCT02442778|144316228|SUPERIORITY||LS Mean Difference|-0.7||||0.019|TWO_SIDED|95.0|-1.3|-0.1||MMRM included fixed effect treatment, visit, treatment-by-visit, baseline, baseline-by-visit, baseline NPI AA (≤ 6 vs. \> 6), risk assessment for falls, baseline concomitant use of antipsychotic medications and cohorts.|MMRM|||||-0.1|-1.3|0.019
72404534|NCT02442778|144316229|SUPERIORITY||LS Mean Difference|0.6||||0.756|TWO_SIDED|95.0|-2.9|4.0||MMRM included fixed effect treatment, visit, treatment-by-visit, baseline, baseline-by-visit, baseline NPI AA (≤ 6 vs. \> 6), risk assessment for falls, baseline concomitant use of antipsychotic medications and cohorts.|MMRM|||||4.0|-2.9|0.756
72404535|NCT02442778|144316229|SUPERIORITY||LS Mean Difference|-3.6||||0.038|TWO_SIDED|95.0|-7.0|-0.2||MMRM included fixed effect treatment, visit, treatment-by-visit, baseline, baseline-by-visit, baseline NPI AA (≤ 6 vs. \> 6), risk assessment for falls, baseline concomitant use of antipsychotic medications and cohorts.|MMRM|||||-0.2|-7.0|0.038
72624430|NCT02507934|144778686|SUPERIORITY||Mean Difference (Final Values)|-0.28||||0.2338|TWO_SIDED|95.0|-0.75|0.19|||Student t-test for unpaired data|||T-test on changes from baseline in Visual acuity score - Left eye - Day 7±1||0.19|-0.75|0.2338
72404536|NCT02442778|144316230|SUPERIORITY||LS Mean Difference|-0.1||||0.468|TWO_SIDED|95.0|-0.3|0.1||MMRM included fixed effect treatment, visit, treatment-by-visit, baseline, baseline-by-visit, baseline NPI AA (≤ 6 vs. \> 6), risk assessment for falls, baseline concomitant use of antipsychotic medications and cohorts.|MMRM|||||0.1|-0.3|0.468
72404537|NCT02442778|144316230|SUPERIORITY||LS Mean Difference|-0.1||||0.158|TWO_SIDED|95.0|-0.3|0.1||MMRM included fixed effect treatment, visit, treatment-by-visit, baseline, baseline-by-visit, baseline NPI AA (≤ 6 vs. \> 6), risk assessment for falls, baseline concomitant use of antipsychotic medications and cohorts.|MMRM|||||0.1|-0.3|0.158
72404538|NCT02442778|144316231|SUPERIORITY||LS Mean Difference|0.1||||0.4|TWO_SIDED|95.0|-0.2|0.4||MMRM included fixed effect treatment, visit, treatment-by-visit, baseline, baseline-by-visit, baseline NPI AA (≤ 6 vs. \> 6), risk assessment for falls, baseline concomitant use of antipsychotic medications and cohorts.|MMRM|||||0.4|-0.2|0.400
72404539|NCT02442778|144316231|SUPERIORITY||LS Mean Difference|-0.1||||0.566|TWO_SIDED|95.0|-0.3|0.2||MMRM included fixed effect treatment, visit, treatment-by-visit, baseline, baseline-by-visit, baseline NPI AA (≤ 6 vs. \> 6), risk assessment for falls, baseline concomitant use of antipsychotic medications and cohorts.|MMRM|||||0.2|-0.3|0.566
72404540|NCT02442778|144316232|SUPERIORITY||LS Mean Difference|0.0||||0.751|TWO_SIDED|95.0|-0.2|0.3||MMRM included fixed effect treatment, visit, treatment-by-visit, baseline, baseline-by-visit, baseline NPI AA (≤ 6 vs. \> 6), risk assessment for falls, baseline concomitant use of antipsychotic medications and cohorts.|MMRM|||||0.3|-0.2|0.751
72404541|NCT02442778|144316232|SUPERIORITY||LS Mean Difference|-0.1||||0.32|TWO_SIDED|95.0|-0.3|0.1||MMRM included fixed effect treatment, visit, treatment-by-visit, baseline, baseline-by-visit, baseline NPI AA (≤ 6 vs. \> 6), risk assessment for falls, baseline concomitant use of antipsychotic medications and cohorts.|MMRM|||||0.1|-0.3|0.320
72404542|NCT02442778|144316233|SUPERIORITY||LS Mean Difference|0.3||||0.782|TWO_SIDED|95.0|-1.8|2.4||MMRM included fixed effect treatment, visit, treatment-by-visit, baseline, baseline-by-visit, baseline NPI AA (≤ 6 vs. \> 6), risk assessment for falls, baseline concomitant use of antipsychotic medications and cohorts.|MMRM|||||2.4|-1.8|0.782
72404543|NCT02442778|144316233|SUPERIORITY||LS Mean Difference|0.0||||0.991|TWO_SIDED|95.0|-2.1|2.0||MMRM included fixed effect treatment, visit, treatment-by-visit, baseline, baseline-by-visit, baseline NPI AA (≤ 6 vs. \> 6), risk assessment for falls, baseline concomitant use of antipsychotic medications and cohorts.|MMRM|||||2.0|-2.1|0.991
72404544|NCT02442778|144316234|SUPERIORITY||LS Mean Difference|0.6||||0.038|TWO_SIDED|95.0|0.0|1.2||MMRM included fixed effect treatment, visit, treatment-by-visit, baseline, baseline-by-visit, baseline NPI AA (≤ 6 vs. \> 6), risk assessment for falls, baseline concomitant use of antipsychotic medications and cohorts.|MMRM|||||1.2|0.0|0.038
72404545|NCT02442778|144316234|SUPERIORITY||LS Mean Difference|0.0||||0.911|TWO_SIDED|95.0|-0.6|0.5||MMRM included fixed effect treatment, visit, treatment-by-visit, baseline, baseline-by-visit, baseline NPI AA (≤ 6 vs. \> 6), risk assessment for falls, baseline concomitant use of antipsychotic medications and cohorts.|MMRM|||||0.5|-0.6|0.911
72404546|NCT02442778|144316236|SUPERIORITY||LS Mean Difference|1.0||||0.236|TWO_SIDED|95.0|-0.6|2.6||MMRM included fixed effect treatment, visit, treatment-by-visit, baseline, baseline-by-visit, baseline NPI AA (≤ 6 vs. \> 6), risk assessment for falls, baseline concomitant use of antipsychotic medications and cohorts.|MMRM|||||2.6|-0.6|0.236
72404547|NCT02442778|144316236|SUPERIORITY||LS Mean Difference|0.3||||0.684|TWO_SIDED|95.0|-1.3|1.9||MMRM included fixed effect treatment, visit, treatment-by-visit, baseline, baseline-by-visit, baseline NPI AA (≤ 6 vs. \> 6), risk assessment for falls, baseline concomitant use of antipsychotic medications and cohorts.|MMRM|||||1.9|-1.3|0.684
72404548|NCT01165138|144316242|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.136||||0.002|TWO_SIDED|95.0|0.051|0.222|||ANCOVA|||||0.222|0.051|0.002
72404549|NCT01165138|144316242|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.172|||<|0.001|TWO_SIDED|95.0|0.087|0.258|||ANCOVA|||||0.258|0.087|<0.001
72624431|NCT02507934|144778686|SUPERIORITY||Mean Difference (Final Values)|-0.19||||0.3081|TWO_SIDED|95.0|-0.58|0.19|||Student t-test for unpaired data|||T-test on changes from baseline in Visual acuity score - Right eye - Day 7±1||0.19|-0.58|0.3081
72624432|NCT02507934|144778686|SUPERIORITY||Mean Difference (Final Values)|1.59||||0.4287|TWO_SIDED|95.0|-2.57|5.74|||Student t-test for unpaired data|||T-test on changes from baseline in Visual acuity score - Left eye - Day 14±1||5.74|-2.57|0.4287
72516579|NCT04847141|144564273|SUPERIORITY||Difference in Percentage|4.9||||0.2507|TWO_SIDED|95.0|-3.6|13.4||p-value was calculated using Chi-square test with 5% level of significance to test the null hypothesis of no difference in the percentage of participants who required at least 1 COVID-19 related MAV between C19-IG 20% 2 g dose group and placebo.|Chi-squared||95% CI for percentage difference between C19-IG 20% 2 g dose group and placebo was calculated using the exact unconditional method.|||13.4|-3.6|0.2507
72516580|NCT04847141|144564274|SUPERIORITY||Difference in Percentage|0.1||||0.9744|TWO_SIDED|95.0|-3.8|4.0||p-value was calculated using Chi-square test with 5% level of significance to test the null hypothesis of no difference in the percentage of participants who required hospital admission between C19-IG 20% 1 g dose group and placebo.|Chi-squared||95% CI for percentage difference between C19-IG 20% 1 g dose group and placebo was calculated using the exact unconditional method.|||4.0|-3.8|0.9744
72516581|NCT04847141|144564274|SUPERIORITY||Difference in Percentage|2.7||||0.1878|TWO_SIDED|95.0|-1.6|7.5||p-value was calculated using Chi-square test with 5% level of significance to test the null hypothesis of no difference in the percentage of participants who required hospital admission between C19-IG 20% 2 g dose group and placebo.|Chi-squared||95% CI for percentage difference between C19-IG 20% 2 g dose group and placebo was calculated using the exact unconditional method.|||7.5|-1.6|0.1878
72516582|NCT04847141|144564275|SUPERIORITY||LS Mean Difference|0.01||||0.9485|TWO_SIDED|95.0|-0.38|0.4|||ANCOVA||95% CI for difference in LS Mean between C19-IG 20% 1 g dose group and placebo was calculated using ANCOVA model, including length of hospital stay as dependent variable \& treatment group as fixed effect, adjusting for baseline.|||0.40|-0.38|0.9485
72516583|NCT04847141|144564275|SUPERIORITY||LS Mean Difference|0.14||||0.4734|TWO_SIDED|95.0|-0.25|0.54|||ANCOVA||95% CI for difference in LS Mean between C19-IG 20% 2 g dose group and placebo was calculated using ANCOVA model, including length of hospital stay as dependent variable \& treatment group as fixed effect, adjusting for baseline.|||0.54|-0.25|0.4734
72516584|NCT04847141|144564276|SUPERIORITY||Difference in Percentage|0.02||||0.9853|TWO_SIDED|95.0|-3.05|3.12||p-value was calculated using Chi-square test with 5% level of significance to test the null hypothesis of no difference in the percentage of participants who required ICU admission between C19-IG 20% 1 g dose group and placebo.|Chi-squared||95% CI for percentage difference between C19-IG 20% 1 g dose group and placebo was calculated using the exact unconditional method.|||3.12|-3.05|0.9853
72516585|NCT04847141|144564276|SUPERIORITY||Difference in Percentage|0.01||||0.989|TWO_SIDED|95.0|-2.99|3.07||p-value was calculated using Chi-square test with 5% level of significance to test the null hypothesis of no difference in the percentage of participants who required ICU admission between C19-IG 20% 2 g dose group and placebo.|Chi-squared||95% CI for percentage difference between C19-IG 20% 2 g dose group and placebo was calculated using the exact unconditional method.|||3.07|-2.99|0.9890
72516586|NCT04847141|144564277|SUPERIORITY||LS Mean Difference|0.03||||0.578|TWO_SIDED|95.0|-0.07|0.12|||ANCOVA||95% CI for difference in LS Mean between C19-IG 20% 1 g dose group and placebo was calculated using ANCOVA model, including length of hospital stay as dependent variable \& treatment group as fixed effect, adjusting for baseline.|||0.12|-0.07|0.5780
72516587|NCT04847141|144564277|SUPERIORITY||LS Mean Difference|0.01||||0.9065|TWO_SIDED|95.0|-0.09|0.1|||ANCOVA||95% CI for difference in LS Mean between C19-IG 20% 2 g dose group and placebo was calculated using ANCOVA model, including length of hospital stay as dependent variable \& treatment group as fixed effect, adjusting for baseline.|||0.10|-0.09|0.9065
72516588|NCT04847141|144564281|SUPERIORITY||Difference in Percentage|0.02||||0.9853|TWO_SIDED|95.0|-3.05|3.12||p-value was calculated using Chi-square test with 5% level of significance to test the null hypothesis of no difference in the percentage of participants with critical COVID-19 illness between C19-IG 20% 1 g dose group and placebo.|Chi-squared||95% CI for percentage difference between C19-IG 20% 1 g dose group and placebo was calculated using the exact unconditional method.|||3.12|-3.05|0.9853
72516589|NCT04847141|144564281|SUPERIORITY||Difference in Percentage|0.01||||0.989|TWO_SIDED|95.0|-2.99|3.07||p-value was calculated using Chi-square test with 5% level of significance to test the null hypothesis of no difference in the percentage of participants with critical COVID-19 illness between C19-IG 20% 2 g dose group and placebo.|Chi-squared||95% CI for percentage difference between C19-IG 20% 2 g dose group and placebo was calculated using the exact unconditional method.|||3.07|-2.99|0.9890
72516590|NCT01634113|144564284|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.08|STANDARD_ERROR_OF_MEAN|0.117||0.4963|TWO_SIDED|95.0|-0.312|0.152||All treatment comparisons were exploratory, no formal hypothesis testing was performed.|ANCOVA||Difference calculated as Tio R2.5 minus placebo|||0.152|-0.312|0.4963
72516591|NCT01634113|144564284|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.048|STANDARD_ERROR_OF_MEAN|0.123||0.6936|TWO_SIDED|95.0|-0.292|0.195||All treatment comparisons were exploratory, no formal hypothesis testing was performed.|ANCOVA||Difference calculated as Tio R5 minus placebo|||0.195|-0.292|0.6936
72516592|NCT01634113|144564286|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.083|STANDARD_ERROR_OF_MEAN|0.157||0.5995|TWO_SIDED|95.0|-0.229|0.394||All treatment comparisons were exploratory, no formal hypothesis testing was performed.|ANCOVA||Difference calculated as Tio R2.5 minus placebo|||0.394|-0.229|0.5995
72516593|NCT01634113|144564286|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.015|STANDARD_ERROR_OF_MEAN|0.16||0.9251|TWO_SIDED|95.0|-0.303|0.333||All treatment comparisons were exploratory, no formal hypothesis testing was performed.|ANCOVA||Difference calculated as Tio R5 minus placebo|||0.333|-0.303|0.9251
72516594|NCT01634113|144564287|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.25|STANDARD_ERROR_OF_MEAN|10.324||0.8279|TWO_SIDED|95.0|-18.243|22.743||All treatment comparisons were exploratory, no formal hypothesis testing was performed.|ANCOVA||Difference calculated as Tio R2.5 minus placebo|||22.743|-18.243|0.8279
72516595|NCT01634113|144564287|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.497|STANDARD_ERROR_OF_MEAN|10.826||0.8181|TWO_SIDED|95.0|-23.987|18.994||All treatment comparisons were exploratory, no formal hypothesis testing was performed.|ANCOVA||Difference calculated as Tio R5 minus placebo|||18.994|-23.987|0.8181
72404550|NCT01165138|144316242|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.036||||0.405|TWO_SIDED|95.0|-0.048|0.12|||ANCOVA|||||0.120|-0.048|0.405
72490331|NCT02831673|144508364|OTHER||Hazard Ratio (HR)|1.0||||0.658|TWO_SIDED|95.0|0.86|1.16||The generalized Wilcoxon procedure was used to estimate a p-value for detecting a difference in cumulative incidence curves between treatment groups.|Generalized Wilcoxon procedure||Hazard ratios were estimated using the Cox proportional hazard regression model.|||1.16|0.86|0.658
72568655|NCT04168190|144668507|NON_INFERIORITY|Non-inferiority can be concluded if the lower bound of the 95% CI for the estimated GMC ratio (V116/PPSV23) is \>0.5 (1-sided p-value \<0.025).|GMC Ratio|1.36|||<|0.001|TWO_SIDED|95.0|1.06|1.75|||P-value is estimated from a cLDA model.||Phase 2: V116/Phase 2: Pneumovax™23|Serotype 22F. Geometric mean concentration (GMC) ratio, 95% confidence interval (CI), and p-value are estimated from a constrained longitudinal data analysis (cLDA) model.||1.75|1.06|<0.001
72624433|NCT02507934|144778686|SUPERIORITY||Mean Difference (Final Values)|1.15||||0.5765|TWO_SIDED|95.0|-3.14|5.44|||Student t-test for unpaired data|||T-test on changes from baseline in Visual acuity score - Right eye - Day 14±1||5.44|-3.14|0.5765
72404551|NCT01165138|144316243|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.186||||0.003|TWO_SIDED|95.0|0.062|0.31|||ANCOVA|||||0.310|0.062|0.003
72404552|NCT01165138|144316243|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.302|||<|0.001|TWO_SIDED|95.0|0.178|0.426|||ANCOVA|||||0.426|0.178|<0.001
72490332|NCT02831673|144508368|OTHER||Mean Difference (Net)|17.1||||0.206|TWO_SIDED|95.0|-9.4|43.6|||Mixed Model Repeated Measures (MMRM)||Week 24. Following covariates/factors were adjusted: treatment, visit, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, treatment and visit interaction and Baseline CD4+ cell count and visit interaction with visit as the repeated factor.|||43.6|-9.4|0.206
72490333|NCT02831673|144508368|OTHER||Mean Difference (Net)|4.6||||0.754|TWO_SIDED|95.0|-23.9|33.0|||Mixed Model Repeated Measures (MMRM)||Week 48. Following covariates/factors were adjusted: treatment, visit, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, treatment and visit interaction and Baseline CD4+ cell count and visit interaction with visit as the repeated factor.|||33.0|-23.9|0.754
72490334|NCT02831673|144508369|OTHER||Mean Difference (Net)|10.8||||0.5|TWO_SIDED|95.0|-20.7|42.4|||Mixed Model Repeated Measures (MMRM)||Week 96. Following covariates/factors were adjusted: treatment, visit, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, treatment and visit interaction and Baseline CD4+ cell count and visit interaction with visit as the repeated factor.|||42.4|-20.7|0.500
72490335|NCT02831673|144508370|OTHER||Mean Difference (Net)|-1.4||||0.934|TWO_SIDED|95.0|-34.2|31.5|||Mixed Model Repeated Measures (MMRM)||Week 144.Following covariates/factors were adjusted: treatment, visit, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, treatment and visit interaction and Baseline CD4+ cell count and visit interaction with visit as the repeated factor.|||31.5|-34.2|0.934
72490336|NCT02831673|144508381|OTHER||Mean Difference (Net)|-0.02||||0.025|TWO_SIDED|95.0|-0.04|0.0|||Mixed Model Repeated Measures||Serum Cystatin C, Week 24|||0.00|-0.04|0.025
72490337|NCT02831673|144508381|OTHER||Mean Difference (Net)|-0.03||||0.001|TWO_SIDED|95.0|-0.05|-0.01|||Mixed Model Repeated Measures||Serum Cystatin C, Week 48|||-0.01|-0.05|0.001
72490338|NCT02831673|144508381|OTHER||Mean Difference (Net)|-0.3||||0.683|TWO_SIDED|95.0|-1.6|1.0|||Mixed Model Repeated Measures||Serum RBP, Week 24|||1.0|-1.6|0.683
72490339|NCT02831673|144508381|OTHER||Mean Difference (Net)|-0.1||||0.93|TWO_SIDED|95.0|-1.4|1.2|||Mixed Model Repeated Measures||Serum RBP, Week 48|||1.2|-1.4|0.930
72490340|NCT02831673|144508382|OTHER||Mean Difference (Net)|-0.02||||0.009|TWO_SIDED|95.0|-0.04|-0.01|||Mixed Model Repeated Measures||Week 96. Serum Cystatin C.|||-0.01|-0.04|0.009
72490341|NCT02831673|144508383|OTHER||Mean Difference (Net)|-0.01||||0.108|TWO_SIDED|95.0|-0.03|0.0|||Mixed Model Repeated Measures||Week 144. Serum Cystatin C.|||-0.00|-0.03|0.108
72490342|NCT02831673|144508386|OTHER||Mean Difference (Net)|2.2||||0.011|TWO_SIDED|95.0|0.5|4.0|||Mixed Model Repeated Measures||GFR-cystatin C adjusted, Week 24|||4.0|0.5|0.011
72490343|NCT02831673|144508386|OTHER||Mean Difference (Net)|2.8|||<|0.001|TWO_SIDED|95.0|1.2|4.5|||Mixed Model Repeated Measures||GFR-cystatin C adjusted, Week 48|||4.5|1.2|<0.001
72490344|NCT02831673|144508386|OTHER||Mean Difference (Net)|3.2|||<|0.001|TWO_SIDED|95.0|1.6|4.8|||Mixed Model Repeated Measures||GFR-creatinine adjusted, Week 24|||4.8|1.6|<0.001
72490345|NCT02831673|144508386|OTHER||Mean Difference (Net)|3.5|||<|0.001|TWO_SIDED|95.0|2.0|5.1|||Mixed Model Repeated Measures||GFR- creatinine adjusted, Week 48|||5.1|2.0|<0.001
72490346|NCT02831673|144508389|OTHER||Mean Difference (Net)|-3.19|||<|0.001|TWO_SIDED|95.0|-4.62|-1.75|||Mixed Model Repeated Measures||Week 24|||-1.75|-4.62|<0.001
72490347|NCT02831673|144508389|OTHER||Mean Difference (Net)|-3.22|||<|0.001|TWO_SIDED|95.0|-4.54|-1.91|||Mixed Model Repeated Measures||Week 48|||-1.91|-4.54|<0.001
72490348|NCT02831673|144508390|OTHER||Mean Difference (Net)|-3.34|||<|0.001|TWO_SIDED|95.0|-4.96|-1.72|||Mixed Model Repeated Measures||Week 96. Serum or Plasma creatinine|||-1.72|-4.96|<0.001
72490349|NCT02831673|144508391|OTHER||Mean Difference (Net)|-2.98|||<|0.001|TWO_SIDED|95.0|-4.57|-1.4|||Mixed Model Repeated Measures||Week 144. Serum or Plasma creatinine|||-1.40|-4.57|<0.001
72404553|NCT01165138|144316243|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.116||||0.06|TWO_SIDED|95.0|-0.005|0.236|||ANCOVA|||||0.236|-0.005|0.060
72490350|NCT02831673|144508392|OTHER||Ratio of geometric means|0.915|||<|0.001|TWO_SIDED|95.0|0.887|0.943|||Mixed Model Repeated Measures||Week 24. Serum B2M|||0.943|0.887|<0.001
72490351|NCT02831673|144508392|OTHER||Ratio of geometric means|0.904|||<|0.001|TWO_SIDED|95.0|0.88|0.929|||Mixed Model Repeated Measures||Week 48. Serum B2M|||0.929|0.880|<0.001
72490352|NCT02831673|144508392|OTHER||Ratio of geometric means|0.656||||0.005|TWO_SIDED|95.0|0.491|0.877|||Mixed Model Repeated Measures||Week 24. Urine B2M|||0.877|0.491|0.005
72490353|NCT02831673|144508392|OTHER||Ratio of geometric means|0.672|||<|0.001|TWO_SIDED|95.0|0.551|0.821|||Mixed Model Repeated Measures||Week 48. Urine B2M|||0.821|0.551|<0.001
72490354|NCT02831673|144508392|OTHER||Ratio of geometric means|0.965||||0.575|TWO_SIDED|95.0|0.853|1.092|||Mixed Model Repeated Measures||Week 24. Urine Albumin/Creatinine|||1.092|0.853|0.575
72490355|NCT02831673|144508392|OTHER||Ratio of geometric means|0.891||||0.051|TWO_SIDED|95.0|0.793|1.001|||Mixed Model Repeated Measures||Week 48. Urine Albumin/Creatinine|||1.001|0.793|0.051
72490356|NCT02831673|144508392|OTHER||Ratio of geometric means|0.64|||<|0.001|TWO_SIDED|95.0|0.493|0.831|||Mixed Model Repeated Measures||Week 24. Urine B2M/Urine Creatinine|||0.831|0.493|<0.001
72516596|NCT01634113|144564289|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.061|STANDARD_ERROR_OF_MEAN|0.112||0.5869|TWO_SIDED|95.0|-0.161|0.283||All treatment comparisons were exploratory, no formal hypothesis testing was performed.|ANCOVA||Difference calculated as Tio R2.5 minus placebo|||0.283|-0.161|0.5869
72516597|NCT01634113|144564289|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.075|STANDARD_ERROR_OF_MEAN|0.116||0.523|TWO_SIDED|95.0|-0.305|0.156||All treatment comparisons were exploratory, no formal hypothesis testing was performed.|ANCOVA||Difference calculated as Tio R5 minus placebo|||0.156|-0.305|0.5230
72516598|NCT02528253|144564378|SUPERIORITY||Least Square (LS) Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.19||0.1117|TWO_SIDED|95.0|-0.66|0.07|||ANCOVA|||Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. Analysis of covariance (ANCOVA) model for imputed datasets included treatment as a fixed effect, and baseline LBPI as a covariates, and study site as a random effect.||0.07|-0.66|0.1117
72516599|NCT02528253|144564378|SUPERIORITY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.18||0.0281|TWO_SIDED|95.0|-0.76|-0.04|||ANCOVA|||Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline LBPI as a covariates, and study site as a random effect.||-0.04|-0.76|0.0281
72516600|NCT02528253|144564379|SUPERIORITY||LS Mean Difference|-1.32|STANDARD_ERROR_OF_MEAN|0.45||0.0035|TWO_SIDED|95.0|-2.21|-0.43|||ANCOVA|||Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ, and baseline average LBPI as covariates, and study site as a random effect.||-0.43|-2.21|0.0035
72516601|NCT02528253|144564379|SUPERIORITY||LS Mean Difference|-1.74|STANDARD_ERROR_OF_MEAN|0.46||0.0002|TWO_SIDED|95.0|-2.64|-0.83|||ANCOVA|||Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ, and baseline average LBPI as covariates, and study site as a random effect.||-0.83|-2.64|0.0002
72516602|NCT02528253|144564380|SUPERIORITY||LS Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.17||0.3118|TWO_SIDED|95.0|-0.5|0.16|||ANCOVA|||Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.||0.16|-0.50|0.3118
72516603|NCT02528253|144564380|SUPERIORITY||LS Mean Difference|-0.28|STANDARD_ERROR_OF_MEAN|0.17||0.0958|TWO_SIDED|95.0|-0.6|0.05|||ANCOVA|||Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.||0.05|-0.60|0.0958
72516604|NCT02528253|144564381|SUPERIORITY||LS Mean Difference|-0.37|STANDARD_ERROR_OF_MEAN|0.12||0.0015|TWO_SIDED|95.0|-0.6|-0.14|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.||-0.14|-0.60|0.0015
72516605|NCT02528253|144564381|SUPERIORITY||LS Mean Difference|-0.42|STANDARD_ERROR_OF_MEAN|0.12||0.0004|TWO_SIDED|95.0|-0.65|-0.19|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.||-0.19|-0.65|0.0004
72516606|NCT02528253|144564381|SUPERIORITY||LS Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.11||0.0959|TWO_SIDED|95.0|-0.39|0.03|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.||0.03|-0.39|0.0959
72624434|NCT02507934|144778686|SUPERIORITY||Mean Difference (Final Values)|-1.17||||0.0259|TWO_SIDED|95.0|-2.18|-0.15|||Student t-test for unpaired data|||T-test on changes from baseline in Visual acuity score - Left eye - Day 21±1||-0.15|-2.18|0.0259
72624435|NCT02507934|144778686|SUPERIORITY||Mean Difference (Final Values)|-0.93||||0.1496|TWO_SIDED|95.0|-2.23|0.37|||Student t-test for unpaired data|||T-test on changes from baseline in Visual acuity score - Right eye - Day 21±1||0.37|-2.23|0.1496
72624436|NCT02507934|144778687|SUPERIORITY|||||||0.2342|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Eyelid - Meibomian Glands - Right - Day 7±1||||0.2342
72624437|NCT02507934|144778687|SUPERIORITY|||||||0.8874|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Eyelid - Meibomian Glands - Left - Day 7±1||||0.8874
72624438|NCT02507934|144778687|SUPERIORITY|||||||0.0504|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Eyelid - Erythema - Right - Day 7±1||||0.0504
72624439|NCT02507934|144778687|SUPERIORITY|||||||0.0814|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Eyelid - Erythema - Left - Day 7±1||||0.0814
72624440|NCT02507934|144778687|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Eyelid - Oedema - Right - Day 7±1||||1.0000
72516607|NCT02528253|144564381|SUPERIORITY||LS Mean Difference|-0.23|STANDARD_ERROR_OF_MEAN|0.11||0.037|TWO_SIDED|95.0|-0.44|-0.01|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.||-0.01|-0.44|0.0370
72516608|NCT02528253|144564381|SUPERIORITY||LS Mean Difference|-0.48|STANDARD_ERROR_OF_MEAN|0.14||0.0008|TWO_SIDED|95.0|-0.76|-0.2|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.||-0.20|-0.76|0.0008
72516609|NCT02528253|144564381|SUPERIORITY||LS Mean Difference|-0.68|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-0.96|-0.39|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.||-0.39|-0.96|<.0001
72404554|NCT02641379|144316260|SUPERIORITY_OR_OTHER|||||||0.1002|||||||Chi-squared|||For Genotype I, Week 4 response \< 600 U/ml: Comparison of Group A versus Group B was carried out using the Chi-Square test.||||0.1002
72404555|NCT02641379|144316260|SUPERIORITY_OR_OTHER|||||||0.0184|||||||Chi-squared|||For Genotype I, Week 4 response \>= 600 U/ml: Comparison of Group A versus Group B was carried out using the Chi-Square test.||||0.0184
72404556|NCT02641379|144316260|SUPERIORITY_OR_OTHER|||||||0.091|||||||Chi-squared|||For Genotype IV, Week 4 response \< 600 U/ml: Comparison of Group A versus Group B was carried out using the Chi-Square test.||||0.0910
72404557|NCT02641379|144316260|SUPERIORITY_OR_OTHER|||||||1|||||||Chi-squared|||For Genotype IV, Week 4 response \>= 600 U/ml: Comparison of Group A versus Group B was carried out using the Chi-Square test.||||1.0000
72404558|NCT02641379|144316261|SUPERIORITY_OR_OTHER|||||||0.0021||||||The SVR rate i.e., 32.1% participants with genotype I who achieved SVR with 95 % confidence interval of 20.3 to 46.0 in groups A1+B1 was compared with SVR rate in group E using Cochran-Mantel-Haenszel method .|Cochran-Mantel-Haenszel|||Comparison of Groups A1+B1 versus group E stratified by genotype I.||||0.0021
72490357|NCT02831673|144508392|OTHER||Ratio of geometric means|0.695|||<|0.001|TWO_SIDED|95.0|0.576|0.839|||Mixed Model Repeated Measures||Week 48. Urine B2M/Urine Creatinine|||0.839|0.576|<0.001
72490358|NCT02831673|144508392|OTHER||Ratio of geometric means|1.102||||0.099|TWO_SIDED|95.0|0.982|1.237|||Mixed Model Repeated Measures||Week 24. Urine Phosphate|||1.237|0.982|0.099
72490359|NCT02831673|144508392|OTHER||Ratio of geometric means|0.987||||0.816|TWO_SIDED|95.0|0.886|1.1|||Mixed Model Repeated Measures||Week 48. Urine Phosphate|||1.100|0.886|0.816
72490360|NCT02831673|144508392|OTHER||Ratio of geometric means|0.836|||<|0.001|TWO_SIDED|95.0|0.774|0.904|||Mixed Model Repeated Measures||Week 24. Urine Protein/Creatinine|||0.904|0.774|<0.001
72490361|NCT02831673|144508392|OTHER||Ratio of geometric means|0.829|||<|0.001|TWO_SIDED|95.0|0.773|0.888|||Mixed Model Repeated Measures||Week 48. Urine Protein/Creatinine|||0.888|0.773|<0.001
72490362|NCT02831673|144508392|OTHER||Ratio of geometric means|0.871||||0.087|TWO_SIDED|95.0|0.743|1.02|||Mixed Model Repeated Measures||Week 24. Urine RBP 4|||1.020|0.743|0.087
72490363|NCT02831673|144508392|OTHER||Ratio of geometric means|0.748|||<|0.001|TWO_SIDED|95.0|0.644|0.87|||Mixed Model Repeated Measures||Week 48. Urine RBP 4|||0.870|0.644|<0.001
72516610|NCT02528253|144564381|SUPERIORITY||LS Mean Difference|-0.24|STANDARD_ERROR_OF_MEAN|0.13||0.0711|TWO_SIDED|95.0|-0.5|0.02|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.||0.02|-0.50|0.0711
72490364|NCT02831673|144508392|OTHER||Ratio of geometric means|0.828||||0.005|TWO_SIDED|95.0|0.727|0.944|||Mixed Model Repeated Measures||Week 24. Urine RBP 4/Urine Creatinine|||0.944|0.727|0.005
72490365|NCT02831673|144508392|OTHER||Ratio of geometric means|0.765|||<|0.001|TWO_SIDED|95.0|0.677|0.864|||Mixed Model Repeated Measures||Week 48. Urine RBP 4/Urine Creatinine|||0.864|0.677|<0.001
72490366|NCT02831673|144508393|OTHER||Ratio of geometric means|0.839||||0.006|TWO_SIDED|95.0|0.742|0.95|||Mixed Model Repeated Measures||Week 96. Urine Albumin/Creatinine.|||0.950|0.742|0.006
72490367|NCT02831673|144508393|OTHER||Ratio of geometric means|0.551|||<|0.001|TWO_SIDED|95.0|0.445|0.682|||Mixed Model Repeated Measures||Week 96. Urine B2M/Urine Creatinine.|||0.682|0.445|<0.001
72490368|NCT02831673|144508393|OTHER||Ratio of geometric means|1.045||||0.467|TWO_SIDED|95.0|0.928|1.175|||Mixed Model Repeated Measures||Week 96. Urine Phosphate.|||1.175|0.928|0.467
72490369|NCT02831673|144508393|OTHER||Ratio of geometric means|0.824|||<|0.001|TWO_SIDED|95.0|0.764|0.889|||Mixed Model Repeated Measures||Week 96. Urine Protein/Creatinine.|||0.889|0.764|<0.001
72490370|NCT02831673|144508393|OTHER||Ratio of geometric means|0.74|||<|0.001|TWO_SIDED|95.0|0.651|0.84|||Mixed Model Repeated Measures||Week 96. Urine RBP 4/Urine Creatinine|||0.840|0.651|<0.001
72624441|NCT02507934|144778687|SUPERIORITY|||||||0.3855|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Eyelid - Oedema - Left - Day 7±1||||0.3855
72404559|NCT02641379|144316261|SUPERIORITY_OR_OTHER|||||||0.3031||||||The SVR rate i.e., 20.0% participants with genotype IV who achieved SVR with 95 % confidence interval of 0.5 to 71.6 in groups A1+B1 was compared with SVR rate in group E using Cochran-Mantel-Haenszel method .|Cochran-Mantel-Haenszel|||Comparison of Groups A1+B1 versus group E stratified by genotype IV||||0.3031
72404560|NCT04982250|144316275|SUPERIORITY||Risk Difference (RD)|-6.0|||||TWO_SIDED|95.0|-26.0|11.0|||||Risk differences (RD) with 95% confidence intervals (CI) were estimated using regression models with Gaussian distributions, identify links, study group fixed effects, and index peer random effects (to adjust for clustering).|The sample size calculation was based on the primary PrEP initiation outcome at follow-up; 80 clusters (40 per study group) provided 80% power to detect a 17% difference in PrEP initiation between the enhanced (80%) and standard (63%) groups, assuming three referred peers per cluster (75% of those recommended), an intra-cluster correlation coefficient of 0.05, and an alpha level of 0.05.||11|-26|
72490371|NCT02831673|144508394|OTHER||Ratio of geometric means|0.916||||0.205|TWO_SIDED|95.0|0.799|1.05|||Mixed Model Repeated Measures||Week 144. Urine Albumin/Creatinine.|||1.050|0.799|0.205
72490372|NCT02831673|144508394|OTHER||Ratio of geometric means|0.495|||<|0.001|TWO_SIDED|95.0|0.406|0.603|||Mixed Model Repeated Measures||Week 144. Urine B2M/Urine Creatinine.|||0.603|0.406|<0.001
72490373|NCT02831673|144508394|OTHER||Ratio of geometric means|1.089||||0.16|TWO_SIDED|95.0|0.967|1.226|||Mixed Model Repeated Measures||Week 144. Urine Phosphate.|||1.226|0.967|0.160
72490374|NCT02831673|144508394|OTHER||Ratio of geometric means|0.817|||<|0.001|TWO_SIDED|95.0|0.753|0.885|||Mixed Model Repeated Measures||Week 144. Urine Protein/Creatinine.|||0.885|0.753|<0.001
72490375|NCT02831673|144508394|OTHER||Ratio of geometric means|0.679|||<|0.001|TWO_SIDED|95.0|0.607|0.76|||Mixed Model Repeated Measures||Week 144. Urine RBP 4/Urine Creatinine|||0.760|0.607|<0.001
72490376|NCT02831673|144508395|OTHER||Mean Difference (Net)|-2.23|||<|0.001|TWO_SIDED|95.0|-2.75|-1.7|||Mixed Model Repeated Measures||Week 24. Bone ALP|||-1.70|-2.75|<0.001
72490377|NCT02831673|144508395|OTHER||Mean Difference (Net)|-2.58|||<|0.001|TWO_SIDED|95.0|-3.19|-1.98|||Mixed Model Repeated Measures||Week 48. Bone ALP|||-1.98|-3.19|<0.001
72490378|NCT02831673|144508395|OTHER||Mean Difference (Net)|-4.19|||<|0.001|TWO_SIDED|95.0|-5.15|-3.23|||Mixed Model Repeated Measures||Week 28. Serum Osteocalcin|||-3.23|-5.15|<0.001
72490379|NCT02831673|144508395|OTHER||Mean Difference (Net)|-5.23|||<|0.001|TWO_SIDED|95.0|-6.22|-4.23|||Mixed Model Repeated Measures||Week 48. Serum Osteocalcin|||-4.23|-6.22|<0.001
72404561|NCT04982250|144316280|SUPERIORITY||Risk Difference (RD)|39.0|||||TWO_SIDED|95.0|24.0|54.0||||||||54|24|
72404562|NCT04982250|144316281|SUPERIORITY||Risk Difference (RD)|1.0|||||TWO_SIDED|95.0|-10.0|13.0||||||||13|-10|
72490380|NCT02831673|144508395|OTHER||Mean Difference (Net)|-13.8|||<|0.001|TWO_SIDED|95.0|-16.5|-11.1|||Mixed Model Repeated Measures||Week 24. Serum PINP|||-11.1|-16.5|<0.001
72490381|NCT02831673|144508395|OTHER||Mean Difference (Net)|-12.6|||<|0.001|TWO_SIDED|95.0|-15.0|-10.3|||Mixed Model Repeated Measures||Week 48. Serum PINP|||-10.3|-15.0|<0.001
72490382|NCT02831673|144508395|OTHER||Mean Difference (Net)|-0.1628|||<|0.001|TWO_SIDED|95.0|-0.2015|-0.1241|||Mixed Model Repeated Measures||Week 24. CTX-1|||-0.1241|-0.2015|<0.001
72516611|NCT02528253|144564381|SUPERIORITY||LS Mean Difference|-0.24|STANDARD_ERROR_OF_MEAN|0.13||0.0661|TWO_SIDED|95.0|-0.5|0.02|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.||0.02|-0.50|0.0661
72516612|NCT02528253|144564381|SUPERIORITY||LS Mean Difference|-0.44|STANDARD_ERROR_OF_MEAN|0.13||0.0009|TWO_SIDED|95.0|-0.7|-0.18|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.||-0.18|-0.70|0.0009
72516613|NCT02528253|144564381|SUPERIORITY||LS Mean Difference|-0.53|STANDARD_ERROR_OF_MEAN|0.16||0.0008|TWO_SIDED|95.0|-0.84|-0.22|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.||-0.22|-0.84|0.0008
72516614|NCT02528253|144564381|SUPERIORITY||LS Mean Difference|-0.69|STANDARD_ERROR_OF_MEAN|0.16|<|0.0001|TWO_SIDED|95.0|-1.0|-0.38|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.||-0.38|-1.00|<.0001
72516615|NCT02528253|144564381|SUPERIORITY||LS Mean Difference|-0.32|STANDARD_ERROR_OF_MEAN|0.15||0.0274|TWO_SIDED|95.0|-0.61|-0.04|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.||-0.04|-0.61|0.0274
72516616|NCT02528253|144564381|SUPERIORITY||LS Mean Difference|-0.21|STANDARD_ERROR_OF_MEAN|0.15||0.1495|TWO_SIDED|95.0|-0.5|0.08|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.||0.08|-0.50|0.1495
72516617|NCT02528253|144564381|SUPERIORITY||LS Mean Difference|-0.37|STANDARD_ERROR_OF_MEAN|0.15||0.0123|TWO_SIDED|95.0|-0.65|-0.08|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.||-0.08|-0.65|0.0123
72624442|NCT02507934|144778687|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Lashes - Right - Day 7±1||||1.0000
72404563|NCT04982250|144316282|SUPERIORITY||Risk Difference (RD)|-19.0|||||TWO_SIDED|95.0|-40.0|2.0||||||||2|-40|
72490383|NCT02831673|144508395|OTHER||Mean Difference (Net)|-0.2015|||<|0.001|TWO_SIDED|95.0|-0.246|-0.1569|||Mixed Model Repeated Measures||Week 48. CTX-1|||-0.1569|-0.2460|<0.001
72490384|NCT02831673|144508396|OTHER||Mean Difference (Net)|-2.06|||<|0.001|TWO_SIDED|95.0|-2.63|-1.5|||Mixed Model Repeated Measures||Week 96, Bone ALP|||-1.50|-2.63|<0.001
72490385|NCT02831673|144508396|OTHER||Mean Difference (Net)|-4.17|||<|0.001|TWO_SIDED|95.0|-5.2|-3.14|||Mixed Model Repeated Measures||Week 96, Serum Osteocalcin|||-3.14|-5.20|<0.001
72490386|NCT02831673|144508396|OTHER||Mean Difference (Net)|-13.3|||<|0.001|TWO_SIDED|95.0|-17.6|-8.9|||Mixed Model Repeated Measures||Week 96, Serum PINP|||-8.9|-17.6|<0.001
72490387|NCT02831673|144508396|OTHER||Mean Difference (Net)|-0.1592|||<|0.001|TWO_SIDED|95.0|-0.208|-0.1104|||Mixed Model Repeated Measures||Week 96, CTX-1|||-0.1104|-0.2080|<0.001
72490388|NCT02831673|144508397|OTHER||Mean Difference (Net)|-1.68|||<|0.001|TWO_SIDED|95.0|-2.23|-1.14|||Mixed Model Repeated Measures||Week 144, Bone ALP|||-1.14|-2.23|<0.001
72404564|NCT04982250|144316283|SUPERIORITY||Median Difference (Final Values)|-16.9|||||TWO_SIDED|95.0|-36.3|2.5||||||||2.5|-36.3|
72404565|NCT04982250|144316284|SUPERIORITY||Median Difference (Final Values)|0.5|||||TWO_SIDED|95.0|-0.2|1.1||||||||1.1|-0.2|
72490389|NCT02831673|144508397|OTHER||Mean Difference (Net)|-2.91|||<|0.001|TWO_SIDED|95.0|-4.0|-1.83|||Mixed Model Repeated Measures||Week 144, Serum Osteocalcin|||-1.83|-4.00|<0.001
72490390|NCT02831673|144508397|OTHER||Mean Difference (Net)|-9.2|||<|0.001|TWO_SIDED|95.0|-12.3|-6.2|||Mixed Model Repeated Measures||Week 144, Serum PINP|||-6.2|-12.3|<0.001
72490391|NCT02831673|144508397|OTHER||Mean Difference (Net)|-0.1414|||<|0.001|TWO_SIDED|95.0|-0.1771|-0.1056|||Mixed Model Repeated Measures||Week 144, CTX-1|||-0.1056|-0.1771|<0.001
72490392|NCT02831673|144508398|OTHER||Mean Difference (Net)|-6.5|||<|0.001|TWO_SIDED|95.0|-9.9|-3.0|||Mixed Model Repeated Measures||Week 24|||-3.0|-9.9|<0.001
72490393|NCT02831673|144508398|OTHER||Mean Difference (Net)|-6.2|||<|0.001|TWO_SIDED|95.0|-9.0|-3.4|||Mixed Model Repeated Measures||Week 48|||-3.4|-9.0|<0.001
72490394|NCT02831673|144508399|OTHER||Mean Difference (Net)|-2.9||||0.048|TWO_SIDED|95.0|-5.8|0.0|||Mixed Model Repeated Measures||Week 96|||0.0|-5.8|0.048
72490395|NCT02831673|144508400|OTHER||Mean Difference (Net)|-4.9||||0.004|TWO_SIDED|95.0|-8.3|-1.6|||Mixed Model Repeated Measures||Week 144|||-1.6|-8.3|0.004
72516618|NCT02528253|144564381|SUPERIORITY||LS Mean Difference|-0.37|STANDARD_ERROR_OF_MEAN|0.17||0.0307|TWO_SIDED|95.0|-0.71|-0.03|||ANCOVA|||Week 12: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.||-0.03|-0.71|0.0307
72624443|NCT02507934|144778687|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Lashes - Left - Day 7±1||||1.0000
72404566|NCT01644175|144316297|SUPERIORITY_OR_OTHER||LS Mean Difference|-45.9|||<|0.0001|TWO_SIDED|95.0|-52.5|-39.3||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. placebo|Alirocumab group was compared to placebo group using an appropriate contrast statement.||-39.3|-52.5|<0.0001
72490396|NCT02831673|144508407|OTHER||Difference in percentage|2.0||||0.157|TWO_SIDED|95.0|-0.6|4.6||Fisher's exact p-value.|Fisher Exact||Week 24|||4.6|-0.6|0.157
72490397|NCT02831673|144508407|OTHER||Difference in percentage|1.3||||0.414|TWO_SIDED|95.0|-1.7|4.2||Fisher's exact p-value.|Fisher Exact||Week 48|||4.2|-1.7|0.414
72490398|NCT02831673|144508408|OTHER||Difference in percentage|1.0||||0.562|TWO_SIDED|95.0|-2.1|4.1||Fisher's exact p-value.|Fisher Exact||Week 96|||4.1|-2.1|0.562
72490399|NCT02831673|144508409|OTHER||Difference in percentage|0.9||||0.587|TWO_SIDED|95.0|-2.4|4.3||Fisher's exact p-value.|Fisher Exact||Week 144|||4.3|-2.4|0.587
72490400|NCT02831673|144508414|OTHER||Mean Difference (Net)|19.8|||||TWO_SIDED|95.0|-10.23|49.83|||||Baseline plasma HIV-1 RNA,\<=100000. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, and treatment and HIV-1 RNA interaction.|||49.83|-10.23|
72516619|NCT02528253|144564381|SUPERIORITY||LS Mean Difference|-0.58|STANDARD_ERROR_OF_MEAN|0.17||0.0009|TWO_SIDED|95.0|-0.91|-0.24|||ANCOVA|||Week 12: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.||-0.24|-0.91|0.0009
72624444|NCT02507934|144778687|SUPERIORITY|||||||0.4754|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Conjunctiva - Erythema - Right - Day 7±1||||0.4754
72490401|NCT02831673|144508414|OTHER||Mean Difference (Net)|0.67|||||TWO_SIDED|95.0|-57.07|58.4|||||Baseline plasma HIV-1 RNA,\>100000. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, and treatment and HIV-1 RNA interaction.|||58.40|-57.07|
72490402|NCT02831673|144508414|OTHER||Mean Difference (Net)|36.84|||||TWO_SIDED|95.0|-55.94|129.63|||||Baseline CD4+ cell count,\<=200. Following covariates were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, and treatment and Baseline CD4+ cell count interaction.|||129.63|-55.94|
72490403|NCT02831673|144508414|OTHER||Mean Difference (Net)|14.37|||||TWO_SIDED|95.0|-13.38|42.12|||||Baseline CD4+ cell count,\>200. Following covariates were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, and treatment and Baseline CD4+ cell count interaction.|||42.12|-13.38|
72490404|NCT02831673|144508414|OTHER||Mean Difference (Net)|25.14|||||TWO_SIDED|95.0|-9.56|59.85|||||Age\<35. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, age, and treatment and age interaction.|||59.85|-9.56|
72490405|NCT02831673|144508414|OTHER||Mean Difference (Net)|-7.82|||||TWO_SIDED|95.0|-55.98|40.34|||||Age 35 to \<50. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, age, and treatment and age interaction.|||40.34|-55.98|
72490406|NCT02831673|144508414|OTHER||Mean Difference (Net)|29.45|||||TWO_SIDED|95.0|-55.47|114.38|||||Age\>=50. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, age, and treatment and age interaction.|||114.38|-55.47|
72490407|NCT02831673|144508414|OTHER||Mean Difference (Net)|17.67|||||TWO_SIDED|95.0|-49.89|85.23|||||Female. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, gender, and treatment and gender interaction.|||85.23|-49.89|
72624445|NCT02507934|144778687|SUPERIORITY|||||||0.2914|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Conjunctiva - Erythema - Left - Day 7±1||||0.2914
72490408|NCT02831673|144508414|OTHER||Mean Difference (Net)|15.16|||||TWO_SIDED|95.0|-13.9|44.21|||||Male. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, gender, and treatment and gender interaction.|||44.21|-13.90|
72490409|NCT02831673|144508414|OTHER||Mean Difference (Net)|22.51|||||TWO_SIDED|95.0|-9.52|54.54|||||Race group white. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, race group, and treatment and race group interaction.|||54.54|-9.52|
72490410|NCT02831673|144508414|OTHER||Mean Difference (Net)|-26.67|||||TWO_SIDED|95.0|-110.64|57.3|||||Race group African Am/African H.. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, race group, and treatment and race group interaction.|||57.30|-110.64|
72624446|NCT02507934|144778687|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Conjunctiva - Oedema - Right - Day 7±1||||1.0000
72404567|NCT01644175|144316298|SUPERIORITY_OR_OTHER||LS Mean Difference|-49.9|||<|0.0001|TWO_SIDED|95.0|-56.2|-43.6||Threshold for significance was ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. placebo|A hierarchical testing procedure was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when previous endpoint was statistically significant at 0.05 level.||-43.6|-56.2|<0.0001
72404568|NCT01644175|144316299|SUPERIORITY_OR_OTHER||LS Mean Difference|-47.4|||<|0.0001|TWO_SIDED|95.0|-53.6|-41.3||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-41.3|-53.6|<0.0001
72490411|NCT02831673|144508414|OTHER||Mean Difference (Net)|4.44||||||95.0|-76.18|85.06|||||Race group Asian. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, race group, and treatment and race group interaction.|||85.06|-76.18|
72490412|NCT02831673|144508414|OTHER||Mean Difference (Net)|24.96|||||TWO_SIDED|95.0|-60.68|110.59|||||Race group Other. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, race group, and treatment and race group interaction.|||110.59|-60.68|
72568656|NCT04168190|144668507|NON_INFERIORITY|Non-inferiority can be concluded if the lower bound of the 95% CI for the estimated GMC ratio (V116/PPSV23) is \>0.5 (1-sided p-value \<0.025).|GMC Ratio|0.86|||<|0.001|TWO_SIDED|95.0|0.69|1.06|||P-value is estimated from a cLDA model.||Phase 2: V116/Phase 2: Pneumovax™23|Serotype 33F. Geometric mean concentration (GMC) ratio, 95% confidence interval (CI), and p-value are estimated from a constrained longitudinal data analysis (cLDA) model.||1.06|0.69|<0.001
72490413|NCT02831673|144508415|OTHER||Mean Difference (Net)|7.6|||||TWO_SIDED|95.0|-24.6|39.8|||||Baseline plasma HIV-1 RNA,\<=100000. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count and treatment and HIV-1 RNA interaction.|||39.8|-24.6|
72490414|NCT02831673|144508415|OTHER||Mean Difference (Net)|3.0|||||TWO_SIDED|95.0|-59.8|65.9|||||Baseline plasma HIV-1 RNA,\>100000. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count and treatment and HIV-1 RNA interaction.|||65.9|-59.8|
72490415|NCT02831673|144508415|OTHER||Mean Difference (Net)|22.6|||||TWO_SIDED|95.0|-78.3|123.5|||||Baseline CD4+ cell count,\<=200. Following covariates were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, and treatment and Baseline CD4+ cell count interaction.|||123.5|-78.3|
72490416|NCT02831673|144508415|OTHER||Mean Difference (Net)|5.2|||||TWO_SIDED|95.0|-24.7|35.1|||||Baseline CD4+ cell count,\>200. Following covariates were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, and treatment and Baseline CD4+ cell count interaction.|||35.1|-24.7|
72490417|NCT02831673|144508415|OTHER||Mean Difference (Net)|8.4|||||TWO_SIDED|95.0|-29.1|45.9|||||Age\<35. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, age, and treatment and age interaction.|||45.9|-29.1|
72516620|NCT02528253|144564381|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.16||0.2103|TWO_SIDED|95.0|-0.51|0.11|||ANCOVA|||Week 12: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.||0.11|-0.51|0.2103
72516621|NCT02528253|144564381|SUPERIORITY||LS Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.16||0.2656|TWO_SIDED|95.0|-0.48|0.13|||ANCOVA|||Week 12: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.||0.13|-0.48|0.2656
72404569|NCT01644175|144316300|SUPERIORITY_OR_OTHER||LS Mean Difference|-49.3|||<|0.0001|TWO_SIDED|95.0|-55.3|-43.3||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-43.3|-55.3|<0.0001
72404570|NCT01644175|144316301|SUPERIORITY_OR_OTHER||LS Mean Difference|-35.8|||<|0.0001|TWO_SIDED|95.0|-41.3|-30.3||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-30.3|-41.3|<0.0001
72490418|NCT02831673|144508415|OTHER||Mean Difference (Net)|-2.5|||||TWO_SIDED|95.0|-53.9|48.9|||||Age 35 to \<50. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, age, and treatment and age interaction.|||48.9|-53.9|
72516622|NCT02528253|144564381|SUPERIORITY||LS Mean Difference|-0.38|STANDARD_ERROR_OF_MEAN|0.16||0.0152|TWO_SIDED|95.0|-0.68|-0.07|||ANCOVA|||Week 12: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.||-0.07|-0.68|0.0152
72490419|NCT02831673|144508415|OTHER||Mean Difference (Net)|17.7|||||TWO_SIDED|95.0|-74.6|110.1|||||Age\>=50. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, age, and treatment and age interaction.|||110.1|-74.6|
72516623|NCT02528253|144564381|SUPERIORITY||LS Mean Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.19||0.5164|TWO_SIDED|95.0|-0.5|0.25|||ANCOVA|||Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.||0.25|-0.50|0.5164
72568657|NCT04168190|144668507|NON_INFERIORITY|Non-inferiority can be concluded if the lower bound of the 95% CI for the estimated GMC ratio (V116/PPSV23) is \>0.5 (1-sided p-value \<0.025).|GMC Ratio|0.96|||<|0.001|TWO_SIDED|95.0|0.78|1.18|||P-value is estimated from a cLDA model.||Phase 2: V116/Phase 2: Pneumovax™23|Serotype 8. Geometric mean concentration (GMC) ratio, 95% confidence interval (CI), and p-value are estimated from a constrained longitudinal data analysis (cLDA) model.||1.18|0.78|<0.001
72404571|NCT01644175|144316302|SUPERIORITY_OR_OTHER||LS Mean Difference|-37.5|||<|0.0001|TWO_SIDED|95.0|-43.0|-32.0||Threshold for significance ≤0.05.|Mixed Models Analysis||Alirocumab vs. placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-32.0|-43.0|<0.0001
72490420|NCT02831673|144508415|OTHER||Mean Difference (Net)|10.4|||||TWO_SIDED|95.0|-62.3|83.1|||||Female. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, gender, and treatment and gender interaction.|||83.1|-62.3|
72490421|NCT02831673|144508415|OTHER||Mean Difference (Net)|5.6|||||TWO_SIDED|95.0|-25.6|36.9|||||Male. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, gender, and treatment and gender interaction.|||36.9|-25.6|
72490422|NCT02831673|144508415|OTHER||Mean Difference (Net)|6.3|||||TWO_SIDED|95.0|-28.2|40.9|||||Race group white. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, race group, and treatment and race group interaction.|||40.9|-28.2|
72490423|NCT02831673|144508415|OTHER||Mean Difference (Net)|-30.2|||||TWO_SIDED|95.0|-122.7|62.4|||||Race group African Am/African H.. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, race group, and treatment and race group interaction.|||62.4|-122.7|
72490424|NCT02831673|144508415|OTHER||Mean Difference (Net)|49.2|||||TWO_SIDED|95.0|-36.3|134.7|||||Race group Asian. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, race group, and treatment and race group interaction.|||134.7|-36.3|
72490425|NCT02831673|144508415|OTHER||Mean Difference (Net)|-2.5|||||TWO_SIDED|95.0|-94.7|89.7|||||Race group Other. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, race group, and treatment and race group interaction.|||89.7|-94.7|
72490426|NCT02831673|144508416|OTHER||Mean Difference (Net)|1.9|||||TWO_SIDED|95.0|-34.5|38.2|||||Baseline plasma HIV-1 RNA,\<=100000. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, Baseline plasma HIV-1 RNA, and treatment and relevant Baseline plasma HIV-1 RNA interaction.|||38.2|-34.5|
72490427|NCT02831673|144508416|OTHER||Mean Difference (Net)|40.1|||||TWO_SIDED|95.0|-31.2|111.5|||||Baseline plasma HIV-1 RNA,\>100000. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, and treatment and HIV-1 RNA interaction.|||111.5|-31.2|
72490428|NCT02831673|144508416|OTHER||Mean Difference (Net)|-3.9|||||TWO_SIDED|95.0|-122.3|114.5|||||Baseline CD4+ cell count,\<=200. Following covariates were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, and treatment and Baseline CD4+ cell count interaction.|||114.5|-122.3|
72490429|NCT02831673|144508416|OTHER||Mean Difference (Net)|10.8|||||TWO_SIDED|95.0|-22.9|44.5|||||Baseline CD4+ cell count,\>200. Following covariates were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, and treatment and Baseline CD4+ cell count interaction.|||44.5|-22.9|
72516624|NCT02528253|144564381|SUPERIORITY||LS Mean Difference|-0.28|STANDARD_ERROR_OF_MEAN|0.19||0.1488|TWO_SIDED|95.0|-0.66|0.1|||ANCOVA|||Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.||0.10|-0.66|0.1488
72516625|NCT02528253|144564381|SUPERIORITY||LS Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.19||0.2431|TWO_SIDED|95.0|-0.6|0.15|||ANCOVA|||Week 32: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.||0.15|-0.60|0.2431
72516626|NCT02528253|144564381|SUPERIORITY||LS Mean Difference|-0.23|STANDARD_ERROR_OF_MEAN|0.2||0.2428|TWO_SIDED|95.0|-0.62|0.16|||ANCOVA|||Week 32: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.||0.16|-0.62|0.2428
72516627|NCT02528253|144564381|SUPERIORITY||LS Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.2||0.4561|TWO_SIDED|95.0|-0.54|0.24|||ANCOVA|||Week 40: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.||0.24|-0.54|0.4561
72516628|NCT02528253|144564381|SUPERIORITY||LS Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.2||0.3523|TWO_SIDED|95.0|-0.56|0.2|||ANCOVA|||Week 40: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.||0.20|-0.56|0.3523
72516629|NCT02528253|144564381|SUPERIORITY||LS Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.2||0.4403|TWO_SIDED|95.0|-0.53|0.23|||ANCOVA|||Week 48: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.||0.23|-0.53|0.4403
72624447|NCT02507934|144778687|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Conjunctiva - Oedema - Left - Day 7±1||||1.0000
72624448|NCT02507934|144778687|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Lens - Right - Day 7±1||||1.0000
72624449|NCT02507934|144778687|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Lens - Left - Day 7±1||||1.0000
72516630|NCT02528253|144564381|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.2||0.3205|TWO_SIDED|95.0|-0.58|0.19|||ANCOVA|||Week 48: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.||0.19|-0.58|0.3205
72516631|NCT02528253|144564381|SUPERIORITY||LS Mean Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.2||0.5763|TWO_SIDED|95.0|-0.51|0.28|||ANCOVA|||Week 56: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.||0.28|-0.51|0.5763
72404572|NCT01644175|144316303|SUPERIORITY_OR_OTHER||LS Mean Difference|-37.5|||<|0.0001|TWO_SIDED|95.0|-43.5|-31.4||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-31.4|-43.5|<0.0001
72490430|NCT02831673|144508416|OTHER||Mean Difference (Net)|7.3|||||TWO_SIDED|95.0|-35.0|49.6|||||Age Group,\<35. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, age, and treatment and age interaction.|||49.6|-35.0|
72404573|NCT01644175|144316304|SUPERIORITY_OR_OTHER||LS Mean Difference|-40.4|||<|0.0001|TWO_SIDED|95.0|-46.4|-34.4||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-34.4|-46.4|<0.0001
72404574|NCT01644175|144316305|SUPERIORITY_OR_OTHER||LS Mean Difference|-25.0|||<|0.0001|TWO_SIDED|95.0|-29.3|-20.7||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-20.7|-29.3|<0.0001
72404575|NCT01644175|144316306|SUPERIORITY_OR_OTHER||LS Mean Difference|-38.2|||<|0.0001|TWO_SIDED|95.0|-43.7|-32.7||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-32.7|-43.7|<0.0001
72404576|NCT01644175|144316307|SUPERIORITY_OR_OTHER||LS Mean Difference|-40.1|||<|0.0001|TWO_SIDED|95.0|-46.2|-33.9||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-33.9|-46.2|<0.0001
72404577|NCT01644175|144316308|SUPERIORITY_OR_OTHER||LS Mean Difference|-26.4|||<|0.0001|TWO_SIDED|95.0|-31.1|-21.7||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-21.7|-31.1|<0.0001
72490431|NCT02831673|144508416|OTHER||Mean Difference (Net)|-2.5|||||TWO_SIDED|95.0|-60.7|55.7|||||Age Group,35 to \<50. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, age, and treatment and age interaction.|||55.7|-60.7|
72490432|NCT02831673|144508416|OTHER||Mean Difference (Net)|41.6|||||TWO_SIDED|95.0|-61.2|144.5|||||Age\>=50. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, age, and treatment and age interaction.|||144.5|-61.2|
72490433|NCT02831673|144508416|OTHER||Mean Difference (Net)|18.8|||||TWO_SIDED|95.0|-64.2|101.8|||||Female. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, gender, and treatment and gender interaction.|||101.8|-64.2|
72490434|NCT02831673|144508416|OTHER||Mean Difference (Net)|7.8|||||TWO_SIDED|95.0|-27.4|43.1|||||Male. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, gender, and treatment and gender interaction.|||43.1|-27.4|
72490435|NCT02831673|144508416|OTHER||Mean Difference (Net)|15.2|||||TWO_SIDED|95.0|-23.6|54.0|||||Race group-white. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, race, and treatment and race interaction.|||54.0|-23.6|
72490436|NCT02831673|144508416|OTHER||Mean Difference (Net)|-1.7|||||TWO_SIDED|95.0|-106.3|103.0|||||Race group-African Am/African H. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, race, and treatment and race interaction.|||103.0|-106.3|
72490437|NCT02831673|144508416|OTHER||Median Difference (Net)|-32.6|||||TWO_SIDED|95.0|-132.2|66.9|||||Race group-Asian. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, race, and treatment and race interaction.|||66.9|-132.2|
72490438|NCT02831673|144508416|OTHER||Mean Difference (Net)|26.1|||||TWO_SIDED|95.0|-77.3|129.5|||||Race group-Other. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, race, and treatment and race interaction.|||129.5|-77.3|
72490439|NCT02831673|144508417|OTHER||Mean Difference (Net)|-0.4|||||TWO_SIDED|95.0|-39.2|38.3|||||Baseline plasma HIV-1 RNA,\<=100000. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, Baseline plasma HIV-1 RNA, and treatment and relevant Baseline plasma HIV-1 RNA interaction.|||38.3|-39.2|
72490440|NCT02831673|144508417|OTHER||Mean Difference (Net)|4.7|||||TWO_SIDED|95.0|-69.4|78.8|||||Baseline plasma HIV-1 RNA,\>100000. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, Baseline plasma HIV-1 RNA, and treatment and Baseline plasma HIV-1 RNA interaction.|||78.8|-69.4|
72490441|NCT02831673|144508417|OTHER||Mean Difference (Net)|17.4|||||TWO_SIDED|95.0|-111.1|145.8|||||Baseline CD4+ cell count,\<=200. Following covariates were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, and treatment and Baseline CD4+ cell count interaction.|||145.8|-111.1|
72490442|NCT02831673|144508417|OTHER||Mean Difference (Net)|-1.5|||||TWO_SIDED|95.0|-37.2|34.1|||||Baseline CD4+ cell count,\>200. Following covariates were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, and treatment and Baseline CD4+ cell count interaction.|||34.1|-37.2|
72490443|NCT02831673|144508417|OTHER||Mean Difference (Net)|-18.0|||||TWO_SIDED|95.0|-63.2|27.1|||||Age Group,\<35. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, age, and treatment and age interaction.|||27.1|-63.2|
72490444|NCT02831673|144508417|OTHER||Mean Difference (Net)|3.5|||||TWO_SIDED|95.0|-57.0|64.0|||||Age Group,35 to \<50. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, age, and treatment and age interaction.|||64.0|-57.0|
72568658|NCT04168190|144668507|NON_INFERIORITY|Non-inferiority can be concluded if the lower bound of the 95% CI for the estimated GMC ratio (V116/PPSV23) is \>0.5 (1-sided p-value \<0.025).|GMC Ratio|1.3|||<|0.001|TWO_SIDED|95.0|1.04|1.64|||P-value is estimated from a cLDA model.||Phase 2: V116/Phase 2: Pneumovax™23|Serotype 9N. Geometric mean concentration (GMC) ratio, 95% confidence interval (CI), and p-value are estimated from a constrained longitudinal data analysis (cLDA) model.||1.64|1.04|<0.001
72568659|NCT04168190|144668507|NON_INFERIORITY|Non-inferiority can be concluded if the lower bound of the 95% CI for the estimated GMC ratio (V116/PPSV23) is \>0.5 (1-sided p-value \<0.025).|GMC Ratio|1.83|||<|0.001|TWO_SIDED|95.0|1.44|2.32|||P-value is estimated from a cLDA model.||Phase 2: V116/Phase 2: Pneumovax™23|Serotype 10A. Geometric mean concentration (GMC) ratio, 95% confidence interval (CI), and p-value are estimated from a constrained longitudinal data analysis (cLDA) model.||2.32|1.44|<0.001
72568660|NCT04168190|144668507|NON_INFERIORITY|Non-inferiority can be concluded if the lower bound of the 95% CI for the estimated GMC ratio (V116/PPSV23) is \>0.5 (1-sided p-value \<0.025).|GMC Ratio|1.54|||<|0.001|TWO_SIDED|95.0|1.27|1.86|||P-value is estimated from a cLDA model.||Phase 2: V116/Phase 2: Pneumovax™23|Serotype 11A. Geometric mean concentration (GMC) ratio, 95% confidence interval (CI), and p-value are estimated from a constrained longitudinal data analysis (cLDA) model.||1.86|1.27|<0.001
72568661|NCT04168190|144668507|NON_INFERIORITY|Non-inferiority can be concluded if the lower bound of the 95% CI for the estimated GMC ratio (V116/PPSV23) is \>0.5 (1-sided p-value \<0.025).|GMC Ratio|2.3|||<|0.001|TWO_SIDED|95.0|1.75|3.04|||P-value is estimated from a cLDA model.||Phase 2: V116/Phase 2: Pneumovax™23|Serotype 12F. Geometric mean concentration (GMC) ratio, 95% confidence interval (CI), and p-value are estimated from a constrained longitudinal data analysis (cLDA) model.||3.04|1.75|<0.001
72568662|NCT04168190|144668507|NON_INFERIORITY|Non-inferiority can be concluded if the lower bound of the 95% CI for the estimated GMC ratio (V116/PPSV23) is \>0.5 (1-sided p-value \<0.025).|GMC Ratio|1.82|||<|0.001|TWO_SIDED|95.0|1.49|2.22|||P-value is estimated from a cLDA model.||Phase 2: V116/Phase 2: Pneumovax™23|Serotype 17F. Geometric mean concentration (GMC) ratio, 95% confidence interval (CI), and p-value are estimated from a constrained longitudinal data analysis (cLDA) model.||2.22|1.49|<0.001
72568663|NCT04168190|144668507|NON_INFERIORITY|Non-inferiority can be concluded if the lower bound of the 95% CI for the estimated GMC ratio (V116/PPSV23) is \>0.5 (1-sided p-value \<0.025).|GMC Ratio|2.27|||<|0.001|TWO_SIDED|95.0|1.81|2.83|||P-value is estimated from a cLDA model.||Phase 2: V116/Phase 2: Pneumovax™23|Serotype 20A. Geometric mean concentration (GMC) ratio, 95% confidence interval (CI), and p-value are estimated from a constrained longitudinal data analysis (cLDA) model.||2.83|1.81|<0.001
72568664|NCT04168190|144668508|SUPERIORITY|Superiority can be concluded if the lower bound of the 95% CI for the estimated GMC ratio (V116/PPSV23) is \>1.0 (1-sided p-value \<0.025).|GMC Ratio|3.77|||<|0.001|TWO_SIDED|95.0|2.95|4.84|||P-value is estimated from a cLDA model.||Phase 2: V116/Phase 2: Pneumovax™23|Serotype 6A. Geometric mean concentration (GMC) ratio, 95% confidence interval (CI), and p-value are estimated from a constrained longitudinal data analysis (cLDA) model.||4.84|2.95|<0.001
72568665|NCT04168190|144668508|SUPERIORITY|Superiority can be concluded if the lower bound of the 95% CI for the estimated GMC ratio (V116/PPSV23) is \>1.0 (1-sided p-value \<0.025).|GMC Ratio|7.68|||<|0.001|TWO_SIDED|95.0|6.12|9.64|||P-value is estimated from a cLDA model.||Phase 2: V116/Phase 2: Pneumovax™23|Serotype 15A. Geometric mean concentration (GMC) ratio, 95% confidence interval (CI), and p-value are estimated from a constrained longitudinal data analysis (cLDA) model.||9.64|6.12|<0.001
72568666|NCT04168190|144668508|SUPERIORITY|Superiority can be concluded if the lower bound of the 95% CI for the estimated GMC ratio (V116/PPSV23) is \>1.0 (1-sided p-value \<0.025).|GMC Ratio|3.29|||<|0.001|TWO_SIDED|95.0|2.6|4.17|||P-value is estimated from a cLDA model.||Phase 2: V116/Phase 2: Pneumovax™23|Serotype 15C. Geometric mean concentration (GMC) ratio, 95% confidence interval (CI), and p-value are estimated from a constrained longitudinal data analysis (cLDA) model.||4.17|2.60|<0.001
72568667|NCT04168190|144668508|SUPERIORITY|Superiority can be concluded if the lower bound of the 95% CI for the estimated GMC ratio (V116/PPSV23) is \>1.0 (1-sided p-value \<0.025).|GMC Ratio|8.65|||<|0.001|TWO_SIDED|95.0|7.19|10.41|||P-value is estimated from a cLDA model.||Phase 2: V116/Phase 2: Pneumovax™23|Serotype 16F. Geometric mean concentration (GMC) ratio, 95% confidence interval (CI), and p-value are estimated from a constrained longitudinal data analysis (cLDA) model.||10.41|7.19|<0.001
72624450|NCT02507934|144778687|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Iris - Right - Day 7±1||||1.0000
72568668|NCT04168190|144668508|SUPERIORITY|Superiority can be concluded if the lower bound of the 95% CI for the estimated GMC ratio (V116/PPSV23) is \>1.0 (1-sided p-value \<0.025).|GMC Ratio|7.83|||<|0.001|TWO_SIDED|95.0|6.2|9.9|||P-value is estimated from a cLDA model.||Phase 2: V116/Phase 2: Pneumovax™23|Serotype 23A. Geometric mean concentration (GMC) ratio, 95% confidence interval (CI), and p-value are estimated from a constrained longitudinal data analysis (cLDA) model||9.90|6.20|<0.001
72624451|NCT02507934|144778687|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Iris - Left - Day 7±1||||1.0000
72624452|NCT02507934|144778687|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Anterior chamber inflammation - Right - Day 7±1||||1.0000
72624453|NCT02507934|144778687|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Anterior chamber inflammation - Left - Day 7±1||||1.0000
72624454|NCT02507934|144778687|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Cornea transparency - Right - Day 7±1||||1.0000
72624455|NCT02507934|144778687|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Cornea transparency - Left - Day 7±1||||1.0000
72624456|NCT02507934|144778687|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Cornea neovascularization - Right - Day 7±1||||1.0000
72624457|NCT02507934|144778687|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Cornea neovascularization - Left - Day 7±1||||1.0000
72490445|NCT02831673|144508417|OTHER||Mean Difference (Net)|95.2|||||TWO_SIDED|95.0|-14.8|205.2|||||Age Group,\>=50. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, age, and treatment and age interaction.|||205.2|-14.8|
72490446|NCT02831673|144508417|OTHER||Mean Difference (Net)|24.9|||||TWO_SIDED|95.0|-62.5|112.3|||||Female. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, gender, and treatment and gender interaction.|||112.3|-62.5|
72490447|NCT02831673|144508417|OTHER||Mean Difference (Net)|-4.2|||||TWO_SIDED|95.0|-41.5|33.1|||||Male. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, gender, and treatment and gender interaction.|||33.1|-41.5|
72490448|NCT02831673|144508417|OTHER||Mean Difference (Net)|0.3|||||TWO_SIDED|95.0|-40.6|41.1|||||Race group-white. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, race, and treatment and race interaction.|||41.1|-40.6|
72490449|NCT02831673|144508417|OTHER||Mean Difference (Net)|-51.3|||||TWO_SIDED|95.0|-163.6|60.9|||||Race group-African Am/African H. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, race, and treatment and race interaction.|||60.9|-163.6|
72490450|NCT02831673|144508417|OTHER||Median Difference (Net)|-20.1|||||TWO_SIDED|95.0|-125.3|85.0|||||Race group-Asian. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, race, and treatment and race interaction|||85.0|-125.3|
72490451|NCT02831673|144508417|OTHER||Mean Difference (Net)|66.2|||||TWO_SIDED|95.0|-43.7|176.2|||||Race group-Other. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, race, and treatment and race interaction.|||176.2|-43.7|
72490452|NCT02831673|144508418|OTHER||Mean Difference (Net)|0.0052||||0.302|TWO_SIDED|95.0|-0.0047|0.0152|||MMRM||Week 4. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count (factor), and Baseline EQ-5D utility, treatment\*visit and Baseline EQ-5D utility\*visit with visit as the repeated factor|||0.0152|-0.0047|0.302
72490453|NCT02831673|144508418|OTHER||Mean Difference (Net)|-0.0038||||0.45|TWO_SIDED|95.0|-0.0136|0.006|||MMRM||Week24. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count (factor), and Baseline EQ-5D utility, treatment\*visit and Baseline EQ-5D utility\*visit with visit as the repeated factor|||0.0060|-0.0136|0.450
72516632|NCT02528253|144564381|SUPERIORITY||LS Mean Difference|-0.21|STANDARD_ERROR_OF_MEAN|0.2||0.2887|TWO_SIDED|95.0|-0.61|0.18|||ANCOVA|||Week 56: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.||0.18|-0.61|0.2887
72516633|NCT02528253|144564383|SUPERIORITY||LS Mean Difference|-0.84|STANDARD_ERROR_OF_MEAN|0.34||0.0121|TWO_SIDED|95.0|-1.5|-0.18|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ, and baseline average LBPI as covariates, and study site as a random effect.||-0.18|-1.50|0.0121
72516634|NCT02528253|144564383|SUPERIORITY||LS Mean Difference|-1.38|STANDARD_ERROR_OF_MEAN|0.34|<|0.0001|TWO_SIDED|95.0|-2.05|-0.71|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ, and baseline average LBPI as covariates, and study site as a random effect.||-0.71|-2.05|<.0001
72490454|NCT02831673|144508418|OTHER||Mean Difference (Net)|0.0004||||0.934|TWO_SIDED|95.0|-0.0098|0.0106|||MMRM||Week48. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count (factor), and Baseline EQ-5D utility, treatment\*visit and Baseline EQ-5D utility\*visit with visit as the repeated factor|||0.0106|-0.0098|0.934
72490455|NCT02831673|144508419|OTHER||Mean Difference (Net)|-0.0012||||0.842|TWO_SIDED|95.0|-0.0132|0.0107|||MMRM||Week 96. Covariates adjusted: Treatment, Baseline plasma HIV-1 RNA, Baseline CD4+ cell count, and Baseline EQ-5D utility, treatment\*visit and Baseline EQ-5D utility\*visit as factors and covariate, with visit as the repeated factor.|||0.0107|-0.0132|0.842
72490456|NCT02831673|144508420|OTHER||Mean Difference (Net)|0.0008||||0.879|TWO_SIDED|95.0|-0.0097|0.0113|||MMRM||Week 144. Covariates adjusted: Treatment, Baseline plasma HIV-1 RNA, Baseline CD4+ cell count, and Baseline EQ-5D utility, treatment\*visit and Baseline EQ-5D utility\*visit as factors and covariate, with visit as the repeated factor.|||0.0113|-0.0097|0.879
72490457|NCT02831673|144508421|OTHER||Mean Difference (Net)|1.1||||0.137|TWO_SIDED|95.0|-0.3|2.4|||MMRM||Week 4. Covariates adjusted: Treatment, Baseline plasma HIV-1 RNA (factor),Baseline CD4+ cell count (factor), Baseline EQ-5D thermometer, treatment\*visit and Baseline EQ-5D thermometer\*visit with visit as the repeated factor|||2.4|-0.3|0.137
72490458|NCT02831673|144508421|OTHER||Mean Difference (Net)|0.6||||0.458|TWO_SIDED|95.0|-0.9|2.0|||MMRM||Week24. Covariates adjusted: Treatment, Baseline plasma HIV-1 RNA (factor),Baseline CD4+ cell count (factor), Baseline EQ-5D thermometer, treatment\*visit and Baseline EQ-5D thermometer\*visit with visit as the repeated factor|||2.0|-0.9|0.458
72490459|NCT02831673|144508421|OTHER||Mean Difference (Net)|1.5||||0.031|TWO_SIDED|95.0|0.1|2.8|||MMRM||Week48. Covariates adjusted: Treatment, Baseline plasma HIV-1 RNA (factor),Baseline CD4+ cell count (factor), Baseline EQ-5D thermometer, treatment\*visit and Baseline EQ-5D thermometer\*visit with visit as the repeated factor|||2.8|0.1|0.031
72624458|NCT02507934|144778687|SUPERIORITY|||||||0.2429|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Eyelid - Meibomian Glands - Right - Day 14±1||||0.2429
72624459|NCT02507934|144778687|SUPERIORITY|||||||0.5707|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Eyelid - Meibomian Glands - Left - Day 14±1||||0.5707
72624460|NCT02507934|144778687|SUPERIORITY|||||||0.0092|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Eyelid - Erythema - Right - Day 14±1||||0.0092
72624461|NCT02507934|144778687|SUPERIORITY|||||||0.0039|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Eyelid - Erythema - Left - Day 14±1||||0.0039
72624462|NCT02507934|144778687|SUPERIORITY|||||||0.2882|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Eyelid - Oedema - Right - Day 14±1||||0.2882
72490460|NCT02831673|144508422|OTHER||Mean Difference (Net)|1.7||||0.027|TWO_SIDED|95.0|0.2|3.2|||MMRM||Week 96. Covariates adjusted: Treatment, Baseline plasma HIV-1 RNA, Baseline CD4+ cell count and Baseline EQ-5D utility, treatment\*visit and Baseline EQ-5D utility\*visit as factors and covariate, with visit as the repeated factor.|||3.2|0.2|0.027
72490461|NCT02831673|144508423|OTHER||Mean Difference (Net)|2.3||||0.001|TWO_SIDED|95.0|0.9|3.6|||MMRM||Week 144. Covariates adjusted: Treatment, Baseline plasma HIV-1 RNA, Baseline CD4+ cell count and Baseline EQ-5D utility, treatment\*visit and Baseline EQ-5D utility\*visit as factors and covariate, with visit as the repeated factor.|||3.6|0.9|0.001
72490462|NCT03615183|144508431|SUPERIORITY|Adjusted by Placebo data pooled from historical placebo data from recent monotherapy studies in HIV-1 infected participants (NCT00100048, NCT01466985, NCT01152255, and NCT01353898) and fitted with a longitudinal data analysis (LDA) model containing fixed effects for study and time, and a random effect for participants.|Posterior Mean Difference|-1.36|||||||||||||Posterior Probability (PP) of true mean difference in the plasma HIV-1 RNA change from baseline between MK-8527 and placebo ≤ -1.0 copies/mL was 99.72%.|It was hypothesized that the true mean difference in the plasma HIV-1 RNA reduction from baseline between MK- 8527 and placebo is at least 1.0 log10 copies/mL.||||
72490463|NCT03615183|144508431|SUPERIORITY|Adjusted by Placebo data pooled from historical placebo data from recent monotherapy studies in HIV-1 infected participants (NCT00100048, NCT01466985, NCT01152255, and NCT01353898) and fitted with a LDA model containing fixed effects for study and time, and a random effect for participants.|Posterior Mean Difference|-1.63|||||||||||||PP of true mean difference in the plasma HIV-1 RNA change from baseline between MK-8527 and placebo ≤ -1.0 copies/mL was 99.86%.|It was hypothesized that the true mean difference in the plasma HIV-1 RNA reduction from baseline between MK- 8527 and placebo is at least 1.0 log10 copies/mL.||||
72490464|NCT03615183|144508431|SUPERIORITY|Adjusted by Placebo data pooled from historical placebo data from recent monotherapy studies in HIV-1 infected participants (NCT00100048, NCT01466985, NCT01152255, and NCT01353898) and fitted with a LDA model containing fixed effects for study and time, and a random effect for participants.|Posterior Mean Difference|-0.92|||||||||||||PP of true mean difference in the plasma HIV-1 RNA change from baseline between MK-8527 and placebo ≤ -1.0 copies/mL was 9.42%.|It was hypothesized that the true mean difference in the plasma HIV-1 RNA reduction from baseline between MK- 8527 and placebo is at least 1.0 log10 copies/mL.||||
72490465|NCT01977781|144508448|SUPERIORITY_OR_OTHER|||||||0.0019|||||||Wilcoxon (Mann-Whitney)|||Only the statistical analysis results for burning sensation at 10 weeks are reported below as they where the only tolerability results found to be significantly different between the two arms. All other tolerability measures were found to be the same between the two groups.||||0.0019
72490466|NCT03045861|144508482|OTHER||Emax|-1.822|||||TWO_SIDED|95.0|-2.333|1.31||||||||1.310|-2.333|
72490467|NCT03045861|144508482|OTHER||ED50|1020.755|||||TWO_SIDED|95.0|100.786|1940.724||||||||1940.724|100.786|
72490468|NCT03045861|144508482|OTHER||s2e|0.2|||||TWO_SIDED|95.0|0.095|0.306||||||||0.306|0.095|
72490469|NCT03045861|144508483|OTHER||Emax|-1.801|||||TWO_SIDED|95.0|-2.319|-1.283||||||||-1.283|-2.319|
72490470|NCT03045861|144508483|OTHER||ED50|55.572|||||TWO_SIDED|95.0|3.565|107.579||||||||107.579|3.565|
72516635|NCT02528253|144564383|SUPERIORITY||LS Mean Difference|-0.28|STANDARD_ERROR_OF_MEAN|0.31||0.3697|TWO_SIDED|95.0|-0.89|0.33|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ, and baseline average LBPI as covariates, and study site as a random effect.||0.33|-0.89|0.3697
72516636|NCT02528253|144564383|SUPERIORITY||LS Mean Difference|-0.56|STANDARD_ERROR_OF_MEAN|0.3||0.0658|TWO_SIDED|95.0|-1.16|0.04|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ, and baseline average LBPI as covariates, and study site as a random effect.||0.04|-1.16|0.0658
72624463|NCT02507934|144778687|SUPERIORITY|||||||0.4017|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Eyelid - Oedema - Left - Day 14±1||||0.4017
72490471|NCT03045861|144508483|OTHER||s2e|0.206|||||TWO_SIDED|95.0|0.097|0.314||||||||0.314|0.097|
72490472|NCT03045861|144508484|OTHER||Emax|-1.846|||||TWO_SIDED|95.0|-2.352|-1.34||||||||-1.340|-2.352|
72490473|NCT03045861|144508484|OTHER||ED50|32.415|||||TWO_SIDED|95.0|4.687|60.143||||||||60.143|4.687|
72516637|NCT02528253|144564383|SUPERIORITY||LS Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|0.31||0.0004|TWO_SIDED|95.0|-1.7|-0.5|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ, and baseline average LBPI as covariates, and study site as a random effect.||-0.50|-1.70|0.0004
72624464|NCT02507934|144778687|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Lashes - Right - Day 14±1||||1.0000
72490474|NCT03045861|144508484|OTHER||s2e|0.2|||||TWO_SIDED|95.0|0.094|0.305||||||||0.305|0.094|
72490475|NCT01040351|144508548|NON_INFERIORITY_OR_EQUIVALENCE|. The aggregate result of 6 studies reporting the pregnancy rate of patients with ultrasound visible hydrosalpinx revealed that clinical pregnancy rate among the patients with ultrasound-visible hydrosalpinges was 12.6%. We assumed that the aspiration of hydrosalpinx could restore clinical pregnancy rate to that expected for patients with tubal factor of infertility but without hydrosalpinges (about 36.5% in our hospital)|Odds Ratio (OR)|3.02||||0.023|TWO_SIDED|95.0|1.13|8.0|||Chi-squared|||||8.0|1.13|0.023
72490476|NCT02605187|144508583|SUPERIORITY|||||||0.882||||||Final parameter estimates would be considered significant at P \< 0.05.|ANOVA|||Comparison of pain at rest 24 hours after delivery. Null Hypothesis: all the means are the same.||||0.882
72490477|NCT02605187|144508583|SUPERIORITY|||||||0.565||||||Final parameter estimates would be considered significant at P \< 0.05.|ANOVA|||Comparison of pain at movement 24 hours after delivery. Null Hypothesis: all the means are the same.||||0.565
72624465|NCT02507934|144778687|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Lashes - Left - Day 14±1||||1.0000
72624466|NCT02507934|144778687|SUPERIORITY|||||||0.0731|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Conjunctiva - Erythema - Right - Day 14±1||||0.0731
72624467|NCT02507934|144778687|SUPERIORITY|||||||0.002|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Conjunctiva - Erythema - Left - Day 14±1||||0.0020
72404578|NCT01644175|144316309|SUPERIORITY_OR_OTHER||LS Mean Difference|-43.0|||<|0.0001|TWO_SIDED|95.0|-51.6|-34.3||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-34.3|-51.6|<0.0001
72404579|NCT01644175|144316310|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|38.5|||<|0.0001|TWO_SIDED|95.0|16.5|89.8||Threshold for significance ≤ 0.05.|Regression, Logistic|Multiple imputation approach followed by logistic regression model.|Alirocumab vs. placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||89.8|16.5|<0.0001
72404580|NCT01644175|144316311|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|50.0|||<|0.0001|TWO_SIDED|95.0|20.6|121.0||Threshold for significance ≤ 0.05|Regression, Logistic|Multiple imputation approach followed by logistic regression model|Alirocumab vs. placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||121.0|20.6|<0.0001
72404581|NCT01644175|144316312|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-14.6|||<|0.0001|TWO_SIDED|95.0|-21.3|-7.9||Threshold for significance ≤ 0.05.|Regression, Robust|Multiple imputation approach followed by a robust regression model.|Alirocumab vs. placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-7.9|-21.3|<0.0001
72516638|NCT02528253|144564383|SUPERIORITY||LS Mean Difference|-1.22|STANDARD_ERROR_OF_MEAN|0.38||0.0013|TWO_SIDED|95.0|-1.96|-0.48|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ, and baseline average LBPI as covariates, and study site as a random effect.||-0.48|-1.96|0.0013
72516639|NCT02528253|144564383|SUPERIORITY||LS Mean Difference|-1.96|STANDARD_ERROR_OF_MEAN|0.38|<|0.0001|TWO_SIDED|95.0|-2.7|-1.21|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ, and baseline average LBPI as covariates, and study site as a random effect.||-1.21|-2.70|<.0001
72516640|NCT02528253|144564383|SUPERIORITY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.35||0.3906|TWO_SIDED|95.0|-0.99|0.39|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ, and baseline average LBPI as covariates, and study site as a random effect.||0.39|-0.99|0.3906
72568669|NCT04168190|144668508|SUPERIORITY|Superiority can be concluded if the lower bound of the 95% CI for the estimated GMC ratio (V116/PPSV23) is \>1.0 (1-sided p-value \<0.025).|GMC Ratio|5.61|||<|0.001|TWO_SIDED|95.0|4.53|6.94|||P-value is estimated from a cLDA model.||Phase 2: V116/Phase 2: Pneumovax™23|Serotype 23B. Geometric mean concentration (GMC) ratio, 95% confidence interval (CI), and p-value are estimated from a constrained longitudinal data analysis (cLDA) model.||6.94|4.53|<0.001
72568670|NCT04168190|144668508|SUPERIORITY|Superiority can be concluded if the lower bound of the 95% CI for the estimated GMC ratio (V116/PPSV23) is \>1.0 (1-sided p-value \<0.025).|GMC Ratio|23.99|||<|0.001|TWO_SIDED|95.0|19.35|29.74|||P-value is estimated from a cLDA model.||Phase 2: V116/Phase 2: Pneumovax™23|Serotype 24F. Geometric mean concentration (GMC) ratio, 95% confidence interval (CI), and p-value are estimated from a constrained longitudinal data analysis (cLDA) model.||29.74|19.35|<0.001
72404582|NCT01644175|144316313|SUPERIORITY_OR_OTHER||LS Mean Difference|7.3||||0.0001|TWO_SIDED|95.0|3.6|11.0||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||11.0|3.6|0.0001
72624468|NCT02507934|144778687|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Conjunctiva - Oedema - Right - Day 14±1||||1.0000
72624469|NCT02507934|144778687|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Conjunctiva - Oedema - Left - Day 14±1||||1.0000
72624470|NCT02507934|144778687|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Lens - Right - Day 14±1||||1.0000
72404583|NCT01644175|144316314|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.6||||0.8699|TWO_SIDED|95.0|-8.3|7.0||Threshold for significance ≤ 0.05.|Regression, Robust|Multiple imputation approach followed by a robust regression model.|Alirocumab vs. placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||7.0|-8.3|0.8699
72490478|NCT02605187|144508583|SUPERIORITY|||||||0.022||||||Final parameter estimates would be considered significant at P \< 0.05.|ANOVA|||Comparison of pain at rest 48 hours after delivery. Null Hypothesis: all the means are the same.||||0.022
72490479|NCT02605187|144508583|SUPERIORITY|||||||0.14||||||Final parameter estimates would be considered significant at P \< 0.05.|ANOVA|||Comparison of pain at movement 48 hours after delivery. Null Hypothesis: all the means are the same.||||0.140
72490480|NCT02605187|144508584|SUPERIORITY|||||||0.311||||||Final parameter estimates would be considered significant at P \< 0.05.|Fisher Exact|||Comparison of opioid use 0-24 hours after delivery.||||0.311
72490481|NCT02605187|144508584|SUPERIORITY|||||||0.008||||||Final parameter estimates would be considered significant at P \< 0.05.|Fisher Exact|||Comparison of opioid use 24-48 hours after delivery.||||0.008
72490482|NCT02605187|144508585|SUPERIORITY|||||||0.092|||||||Fisher Exact|||Comparison of presence of pruritus 0-24 hours after delivery.||||0.092
72490483|NCT02605187|144508585|SUPERIORITY|||||||0.269|||||||Fisher Exact|||Comparison of presence of pruritus 24-48 hours after delivery.||||0.269
72490484|NCT02605187|144508586|SUPERIORITY|||||||0.006|||||||ANOVA|||Comparison of pruritus score 24 hours after delivery. Null Hypothesis: all means are equal||||0.006
72490485|NCT02605187|144508586|SUPERIORITY|||||||0.296|||||||ANOVA|||Comparison of pruritus score 48 hours after delivery. Null Hypothesis: all means are equal||||0.296
72490486|NCT02605187|144508587|SUPERIORITY|||||||0.759|||||||Fisher Exact|||Comparison of participants who need medical treatment of pruritus 0-24 hours after delivery.||||0.759
72490487|NCT02605187|144508587|SUPERIORITY|||||||0.761|||||||Fisher Exact|||Comparison of participants who need medical treatment of pruritus 24-48 hours after delivery.||||0.761
72490488|NCT02605187|144508588|SUPERIORITY|||||||0.281|||||||Chi-squared|||||||0.281
72404584|NCT00828191|144316321|NON_INFERIORITY_OR_EQUIVALENCE|The null hypothesis (H0) was tested against the alternative by calculating a two-sided 95% confidence interval for the difference in ongoing pregnancy rates. If the lower bound of the 95% confidence interval was greater than the non-inferiority limit (-10.0%), the null hypothesis was rejected and the test group considered not inferior to the control treatment.|Difference in pregnancy rates|-2.5||||0.52|TWO_SIDED|95.0|-9.4|4.4|||Fisher Exact|||"The non -inferiority hypothesis to be tested for the primary endpoint was that the ongoing pregnancy rate (oPR) in the test group (Pe)was lower than the oPR in the control group (Pc)against the alternative one that the oPR in the test group was equal to or higher than the oPR in the control group.~H0 : Pc\>= Pe + d(-10%) H1 : Pc\< Pe + d(-10%)"||4.4|-9.4|0.52
72516641|NCT02528253|144564383|SUPERIORITY||LS Mean Difference|-0.92|STANDARD_ERROR_OF_MEAN|0.35||0.0082|TWO_SIDED|95.0|-1.6|-0.24|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ, and baseline average LBPI as covariates, and study site as a random effect.||-0.24|-1.60|0.0082
72516642|NCT02528253|144564383|SUPERIORITY||LS Mean Difference|-1.65|STANDARD_ERROR_OF_MEAN|0.35|<|0.0001|TWO_SIDED|95.0|-2.34|-0.97|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ, and baseline average LBPI as covariates, and study site as a random effect.||-0.97|-2.34|<.0001
72516643|NCT02528253|144564383|SUPERIORITY||LS Mean Difference|-1.37|STANDARD_ERROR_OF_MEAN|0.4||0.0006|TWO_SIDED|95.0|-2.15|-0.58|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ, and baseline average LBPI as covariates, and study site as a random effect.||-0.58|-2.15|0.0006
72516644|NCT02528253|144564383|SUPERIORITY||LS Mean Difference|-1.95|STANDARD_ERROR_OF_MEAN|0.4|<|0.0001|TWO_SIDED|95.0|-2.73|-1.16|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ, and baseline average LBPI as covariates, and study site as a random effect.||-1.16|-2.73|<.0001
72516645|NCT02528253|144564383|SUPERIORITY||LS Mean Difference|-0.76|STANDARD_ERROR_OF_MEAN|0.37||0.0385|TWO_SIDED|95.0|-1.47|-0.04|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ, and baseline average LBPI as covariates, and study site as a random effect.||-0.04|-1.47|0.0385
72516646|NCT02528253|144564383|SUPERIORITY||LS Mean Difference|-1.34|STANDARD_ERROR_OF_MEAN|0.37||0.0003|TWO_SIDED|95.0|-2.06|-0.61|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ, and baseline average LBPI as covariates, and study site as a random effect.||-0.61|-2.06|0.0003
72516647|NCT02528253|144564383|SUPERIORITY||LS Mean Difference|-1.32|STANDARD_ERROR_OF_MEAN|0.45||0.0035|TWO_SIDED|95.0|-2.21|-0.43|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ, and baseline average LBPI as covariates, and study site as a random effect.||-0.43|-2.21|0.0035
72516648|NCT02528253|144564383|SUPERIORITY||LS Mean Difference|-1.74|STANDARD_ERROR_OF_MEAN|0.46||0.0002|TWO_SIDED|95.0|-2.64|-0.83|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ, and baseline average LBPI as covariates, and study site as a random effect.||-0.83|-2.64|0.0002
72516649|NCT02528253|144564383|SUPERIORITY||LS Mean Difference|-0.26|STANDARD_ERROR_OF_MEAN|0.42||0.5412|TWO_SIDED|95.0|-1.09|0.57|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ, and baseline average LBPI as covariates, and study site as a random effect.||0.57|-1.09|0.5412
72516650|NCT02528253|144564383|SUPERIORITY||LS Mean Difference|-1.06|STANDARD_ERROR_OF_MEAN|0.42||0.0107|TWO_SIDED|95.0|-1.87|-0.25|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ, and baseline average LBPI as covariates, and study site as a random effect.||-0.25|-1.87|0.0107
72516651|NCT02528253|144564383|SUPERIORITY||LS Mean Difference|-1.48|STANDARD_ERROR_OF_MEAN|0.42||0.0004|TWO_SIDED|95.0|-2.29|-0.66|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ, and baseline average LBPI as covariates, and study site as a random effect.||-0.66|-2.29|0.0004
72516652|NCT02528253|144564383|SUPERIORITY||LS Mean Difference|-0.98|STANDARD_ERROR_OF_MEAN|0.49||0.0464|TWO_SIDED|95.0|-1.94|-0.02|||ANCOVA|||Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ, and baseline average LBPI as covariates, and study site as a random effect.||-0.02|-1.94|0.0464
72516653|NCT02528253|144564383|SUPERIORITY||LS Mean Difference|-1.33|STANDARD_ERROR_OF_MEAN|0.49||0.0068|TWO_SIDED|95.0|-2.3|-0.37|||ANCOVA|||Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ, and baseline average LBPI as covariates, and study site as a random effect.||-0.37|-2.30|0.0068
72516654|NCT02528253|144564383|SUPERIORITY||LS Mean Difference|-0.72|STANDARD_ERROR_OF_MEAN|0.5||0.1485|TWO_SIDED|95.0|-1.7|0.26|||ANCOVA|||Week 32: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ, and baseline average LBPI as covariates, and study site as a random effect.||0.26|-1.70|0.1485
72624471|NCT02507934|144778687|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Lens - Left - Day 14±1||||1.0000
72624472|NCT02507934|144778687|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Iris - Right - Day 14±1||||1.0000
72404585|NCT00828191|144316322|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.8|STANDARD_ERROR_OF_MEAN|1.48||0.54|TWO_SIDED|95.0|-7.6|4.0|||ANOVA|||||4.0|-7.6|0.54
72516655|NCT02528253|144564383|SUPERIORITY||LS Mean Difference|-0.97|STANDARD_ERROR_OF_MEAN|0.5||0.0507|TWO_SIDED|95.0|-1.94|0.0|||ANCOVA|||Week 32: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ, and baseline average LBPI as covariates, and study site as a random effect.||0.00|-1.94|0.0507
72516656|NCT02528253|144564383|SUPERIORITY||LS Mean Difference|-0.59|STANDARD_ERROR_OF_MEAN|0.51||0.248|TWO_SIDED|95.0|-1.6|0.41|||ANCOVA|||Week 40: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ, and baseline average LBPI as covariates, and study site as a random effect.||0.41|-1.60|0.2480
72516657|NCT02528253|144564383|SUPERIORITY||LS Mean Difference|-0.71|STANDARD_ERROR_OF_MEAN|0.51||0.1605|TWO_SIDED|95.0|-1.71|0.28|||ANCOVA|||Week 40: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ, and baseline average LBPI as covariates, and study site as a random effect.||0.28|-1.71|0.1605
72516658|NCT02528253|144564383|SUPERIORITY||LS Mean Difference|-0.47|STANDARD_ERROR_OF_MEAN|0.52||0.3654|TWO_SIDED|95.0|-1.5|0.55|||ANCOVA|||Week 48: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ, and baseline average LBPI as covariates, and study site as a random effect.||0.55|-1.50|0.3654
72516659|NCT02528253|144564383|SUPERIORITY||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.52||0.1782|TWO_SIDED|95.0|-1.71|0.32|||ANCOVA|||Week 48: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ, and baseline average LBPI as covariates, and study site as a random effect.||0.32|-1.71|0.1782
72516660|NCT02528253|144564383|SUPERIORITY||LS Mean Difference|-0.44|STANDARD_ERROR_OF_MEAN|0.52||0.3981|TWO_SIDED|95.0|-1.47|0.58|||ANCOVA|||Week 56: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ, and baseline average LBPI as covariates, and study site as a random effect.||0.58|-1.47|0.3981
72516661|NCT02528253|144564383|SUPERIORITY||LS Mean Difference|-0.83|STANDARD_ERROR_OF_MEAN|0.52||0.1089|TWO_SIDED|95.0|-1.84|0.18|||ANCOVA|||Week 56: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ, and baseline average LBPI as covariates, and study site as a random effect.||0.18|-1.84|0.1089
72516662|NCT02528253|144564385|SUPERIORITY||LS Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.05||0.1472|TWO_SIDED|95.0|-0.18|0.03|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline PGA, and baseline average LBPI as covariates, and study site as a random effect.||0.03|-0.18|0.1472
72516663|NCT02528253|144564385|SUPERIORITY||LS Mean Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.05||0.0135|TWO_SIDED|95.0|-0.24|-0.03|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline PGA, and baseline average LBPI as covariates, and study site as a random effect.||-0.03|-0.24|0.0135
72516664|NCT02528253|144564385|SUPERIORITY||LS Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.05||0.0893|TWO_SIDED|95.0|-0.18|0.01|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline PGA, and baseline average LBPI as covariates, and study site as a random effect.||0.01|-0.18|0.0893
72624473|NCT02507934|144778687|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Iris - Left - Day 14±1||||1.0000
72624474|NCT02507934|144778687|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Anterior chamber inflammation - Right - Day 14±1||||1.0000
72624475|NCT02507934|144778687|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Anterior chamber inflammation - Left - Day 14±1||||1.0000
72624476|NCT02507934|144778687|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Cornea transparency - Right - Day 14±1||||1.0000
72624477|NCT02507934|144778687|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Cornea transparency - Left - Day 14±1||||1.0000
72404586|NCT00828191|144316323|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-2.0||||0.62|TWO_SIDED|95.0|-8.8|4.8|||Fisher Exact|||||4.8|-8.8|0.62
72516665|NCT02528253|144564385|SUPERIORITY||LS Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.05||0.0044|TWO_SIDED|95.0|-0.23|-0.04|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline PGA, and baseline average LBPI as covariates, and study site as a random effect.||-0.04|-0.23|0.0044
72516666|NCT02528253|144564385|SUPERIORITY||LS Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.06||0.0025|TWO_SIDED|95.0|-0.28|-0.06|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline PGA, and baseline average LBPI as covariates, and study site as a random effect.||-0.06|-0.28|0.0025
72516667|NCT02528253|144564385|SUPERIORITY||LS Mean Difference|-0.21|STANDARD_ERROR_OF_MEAN|0.06||0.0002|TWO_SIDED|95.0|-0.32|-0.1|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline PGA, and baseline average LBPI as covariates, and study site as a random effect.||-0.10|-0.32|0.0002
72624478|NCT02507934|144778687|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Cornea neovascularization - Right - Day 14±1||||1.0000
72516668|NCT02528253|144564385|SUPERIORITY||LS Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.05||0.8348|TWO_SIDED|95.0|-0.11|0.09|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline PGA, and baseline average LBPI as covariates, and study site as a random effect.||0.09|-0.11|0.8348
72516669|NCT02528253|144564385|SUPERIORITY||LS Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.05||0.002|TWO_SIDED|95.0|-0.26|-0.06|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline PGA, and baseline average LBPI as covariates, and study site as a random effect.||-0.06|-0.26|0.0020
72624479|NCT02507934|144778687|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Cornea neovascularization - Left - Day 14±1||||1.0000
72624480|NCT02507934|144778687|SUPERIORITY|||||||0.1376|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Eyelid - Meibomian Glands - Right - Day 21±1||||0.1376
72624481|NCT02507934|144778687|SUPERIORITY|||||||0.3252|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Eyelid - Meibomian Glands - Left - Day 21±1||||0.3252
72624482|NCT02507934|144778687|SUPERIORITY|||||||0.0111|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Eyelid - Erythema - Right - Day 21±1||||0.0111
72516670|NCT02528253|144564385|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.05||0.0001|TWO_SIDED|95.0|-0.3|-0.1|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline PGA, and baseline average LBPI as covariates, and study site as a random effect.||-0.10|-0.30|0.0001
72516671|NCT02528253|144564385|SUPERIORITY||LS Mean Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.06||0.0272|TWO_SIDED|95.0|-0.25|-0.01|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline PGA, and baseline average LBPI as covariates, and study site as a random effect.||-0.01|-0.25|0.0272
72516672|NCT02528253|144564385|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.06||0.0009|TWO_SIDED|95.0|-0.31|-0.08|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline PGA, and baseline average LBPI as covariates, and study site as a random effect.||-0.08|-0.31|0.0009
72516673|NCT02528253|144564385|SUPERIORITY||LS Mean Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.05||0.168|TWO_SIDED|95.0|-0.18|0.03|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline PGA, and baseline average LBPI as covariates, and study site as a random effect.||0.03|-0.18|0.1680
72516674|NCT02528253|144564385|SUPERIORITY||LS Mean Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.05||0.2968|TWO_SIDED|95.0|-0.16|0.05|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline PGA, and baseline average LBPI as covariates, and study site as a random effect.||0.05|-0.16|0.2968
72516675|NCT02528253|144564385|SUPERIORITY||LS Mean Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.05||0.0219|TWO_SIDED|95.0|-0.23|-0.02|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline PGA, and baseline average LBPI as covariates, and study site as a random effect.||-0.02|-0.23|0.0219
72516676|NCT02528253|144564385|SUPERIORITY||LS Mean Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.07||0.0717|TWO_SIDED|95.0|-0.25|0.01|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline PGA, and baseline average LBPI as covariates, and study site as a random effect.||0.01|-0.25|0.0717
72516677|NCT02528253|144564385|SUPERIORITY||LS Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.07||0.0207|TWO_SIDED|95.0|-0.29|-0.02|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline PGA, and baseline average LBPI as covariates, and study site as a random effect.||-0.02|-0.29|0.0207
72516678|NCT02528253|144564385|SUPERIORITY||LS Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.06||0.8399|TWO_SIDED|95.0|-0.11|0.13|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline PGA, and baseline average LBPI as covariates, and study site as a random effect.||0.13|-0.11|0.8399
72516679|NCT02528253|144564385|SUPERIORITY||LS Mean Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.06||0.0299|TWO_SIDED|95.0|-0.25|-0.01|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline PGA, and baseline average LBPI as covariates, and study site as a random effect.||-0.01|-0.25|0.0299
72516680|NCT02528253|144564385|SUPERIORITY||LS Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.06||0.006|TWO_SIDED|95.0|-0.29|-0.05|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline PGA, and baseline average LBPI as covariates, and study site as a random effect.||-0.05|-0.29|0.0060
72624483|NCT02507934|144778687|SUPERIORITY|||||||0.0049|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Eyelid - Erythema - Right - Day 21±1||||0.0049
72624484|NCT02507934|144778687|SUPERIORITY|||||||0.1178|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Eyelid - Oedema - Right - Day 21±1||||0.1178
72624485|NCT02507934|144778687|SUPERIORITY|||||||0.9042|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Eyelid - Oedema - Left - Day 21±1||||0.9042
72404587|NCT00283439|144316382|SUPERIORITY_OR_OTHER|||||||0.9654||||||One-sided test|Satterhwaite t-test|||||||0.9654
72624486|NCT02507934|144778687|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Lashes - Right - Day 21±1||||1.0000
72404588|NCT00283439|144316382|SUPERIORITY_OR_OTHER|||||||0.869||||||One-sided test|Satterhwaite t-test|||||||0.8690
72516681|NCT02528253|144564385|SUPERIORITY||LS Mean Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.07||0.1974|TWO_SIDED|95.0|-0.24|0.05|||ANCOVA|||Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline PGA, and baseline average LBPI as covariates, and study site as a random effect.||0.05|-0.24|0.1974
72516682|NCT02528253|144564385|SUPERIORITY||LS Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.07||0.278|TWO_SIDED|95.0|-0.22|0.06|||ANCOVA|||Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ, and baseline average LBPI as covariates, and study site as a random effect.||0.06|-0.22|0.2780
72516683|NCT02528253|144564385|SUPERIORITY||LS Mean Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.07||0.433|TWO_SIDED|95.0|-0.21|0.09|||ANCOVA|||Week 32: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline PGA, and baseline average LBPI as covariates, and study site as a random effect.||0.09|-0.21|0.4330
72516684|NCT02528253|144564385|SUPERIORITY||LS Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.07||0.4946|TWO_SIDED|95.0|-0.2|0.09|||ANCOVA|||Week 32: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline PGA, and baseline average LBPI as covariates, and study site as a random effect.||0.09|-0.20|0.4946
72516685|NCT02528253|144564385|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.08||0.1884|TWO_SIDED|95.0|-0.25|0.05|||ANCOVA|||Week 40: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline PGA, and baseline average LBPI as covariates, and study site as a random effect.||0.05|-0.25|0.1884
72516686|NCT02528253|144564385|SUPERIORITY||LS Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.08||0.521|TWO_SIDED|95.0|-0.2|0.1|||ANCOVA|||Week 40: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline PGA, and baseline average LBPI as covariates, and study site as a random effect.||0.10|-0.20|0.5210
72516687|NCT02528253|144564385|SUPERIORITY||LS Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.08||0.3329|TWO_SIDED|95.0|-0.23|0.08|||ANCOVA|||Week 48: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline PGA, and baseline average LBPI as covariates, and study site as a random effect.||0.08|-0.23|0.3329
72516688|NCT02528253|144564385|SUPERIORITY||LS Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.08||0.5173|TWO_SIDED|95.0|-0.21|0.1|||ANCOVA|||Week 48: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline PGA, and baseline average LBPI as covariates, and study site as a random effect.||0.10|-0.21|0.5173
72516689|NCT02528253|144564385|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.08||0.2346|TWO_SIDED|95.0|-0.25|0.06|||ANCOVA|||Week 56: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline PGA, and baseline average LBPI as covariates, and study site as a random effect.||0.06|-0.25|0.2346
72624487|NCT02507934|144778687|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Lashes - Left - Day 21±1||||1.0000
72624488|NCT02507934|144778687|SUPERIORITY|||||||0.0253|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Conjunctiva - Erythema - Right - Day 21±1||||0.0253
72404589|NCT00283439|144316382|SUPERIORITY_OR_OTHER|||||||0.7133||||||One-sided test|Satterhwaite t-test|||||||0.7133
72404590|NCT00283439|144316383|SUPERIORITY_OR_OTHER|||||||0.294|||||||Fisher Exact|||||||0.294
72404591|NCT00283439|144316383|SUPERIORITY_OR_OTHER|||||||0.608|||||||Fisher Exact|||||||0.608
72404592|NCT00283439|144316383|SUPERIORITY_OR_OTHER|||||||0.603|||||||Fisher Exact|||||||0.603
72404593|NCT00283439|144316384|SUPERIORITY_OR_OTHER|||||||0.091|||||||Satterhwaite t-test|||||||0.091
72516690|NCT02528253|144564385|SUPERIORITY||LS Mean Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.08||0.3634|TWO_SIDED|95.0|-0.23|0.09|||ANCOVA|||Week 56: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline PGA, and baseline average LBPI as covariates, and study site as a random effect.||0.09|-0.23|0.3634
72624489|NCT02507934|144778687|SUPERIORITY|||||||0.0016|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Conjunctiva - Erythema - Left - Day 21±1||||0.0016
72624490|NCT02507934|144778687|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Conjunctiva - Oedema - Right - Day 21±1||||1.0000
72404594|NCT00283439|144316384|SUPERIORITY_OR_OTHER|||||||0.3|||||||Satterhwaite t-test|||||||0.300
72404595|NCT00283439|144316384|SUPERIORITY_OR_OTHER|||||||0.881|||||||Satterhwaite t-test|||||||0.881
72404596|NCT00283439|144316385|SUPERIORITY_OR_OTHER|||||||0.576|||||||Fisher Exact|||||||0.576
72404597|NCT00283439|144316385|SUPERIORITY_OR_OTHER|||||||0.588|||||||Fisher Exact|||||||0.588
72404598|NCT00283439|144316385|SUPERIORITY_OR_OTHER|||||||0.421|||||||Fisher Exact|||||||0.421
72404599|NCT02624284|144316456|SUPERIORITY|Analysis: Multiple regression predicting main effects of dose on latency to smoke. Age, sex, race, nicotine dependence, and pre-session craving for negative affect relief (QSU-B Factor 2) were included as covariates.||||||0.94|||||||Regression, Linear|||||||0.94
72624491|NCT02507934|144778687|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Conjunctiva - Oedema - Left - Day 21±1||||1.0000
72404600|NCT02624284|144316457|SUPERIORITY|Analysis: Multiple regression predicting main effects of dose on number of cigarettes smoked. Age, sex, race, nicotine dependence, and pre-session craving for negative affect relief (QSU-B Factor 2) were included as covariates.||||||0.53|||||||Regression, Linear|||||||0.53
72404601|NCT02624284|144316459|SUPERIORITY|Analysis: Multiple regression predicting main effects of dose on days of abstinence. Age, sex, race and nicotine dependence were included as covariates.||||||0.78|||||||Regression, Linear|||||||0.78
72404602|NCT00265616|144316526|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|||||||1.00
72404603|NCT00265616|144316527|SUPERIORITY_OR_OTHER|||||||0.67||95.0|||||Fisher Exact|||||||0.67
72404604|NCT00265616|144316528|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|||||||1.00
72404605|NCT00265616|144316530|SUPERIORITY_OR_OTHER|||||||0.4||95.0|||||Fisher Exact|||||||0.4
72404606|NCT00265616|144316531|SUPERIORITY_OR_OTHER|||||||0.03||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.03
72404607|NCT00654381|144316532|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.87|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001|TWO_SIDED|95.0|-1.04|-0.7|||ANCOVA|Model includes treatment,baseline HbA1c, and number of previous antidiabetic medication||Linagliptin 5 mg vs placebo at week 12||-0.7|-1.04|<0.0001
72404608|NCT00654381|144316532|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.88|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001|TWO_SIDED|95.0|-1.05|-0.71|||ANCOVA|Model includes treatment,baseline HbA1c, and number of previous antidiabetic medication||Linagliptin 10 mg vs placebo at week 12||-0.71|-1.05|<0.0001
72624492|NCT02507934|144778687|SUPERIORITY|||||||0.3165|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Lens - Right - Day 21±1||||0.3165
72404609|NCT00654381|144316533|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.32|STANDARD_ERROR_OF_MEAN|0.09||0.0003|TWO_SIDED|95.0|-0.49|-0.15|||ANCOVA|Model includes treatment,baseline HbA1c, and number of previous antidiabetic medication||||-0.15|-0.49|0.0003
72624493|NCT02507934|144778687|SUPERIORITY|||||||0.3165|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Lens - Left - Day 21±1||||0.3165
72404610|NCT00654381|144316533|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.39|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001|TWO_SIDED|95.0|-0.56|-0.21|||ANCOVA|Model includes treatment,baseline HbA1c, and number of previous antidiabetic medication||Linagliptin 10 mg vs voglibose at week 26||-0.21|-0.56|<0.0001
72404611|NCT00654381|144316537|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-19.7|STANDARD_ERROR_OF_MEAN|2.9|<|0.0001|TWO_SIDED|95.0|-25.4|-14.0|||ANCOVA|Model includes treatment,baseline FPG, and number of previous antidiabetic medication||Linagliptin 5 mg vs placebo at week 12||-14.0|-25.4|<0.0001
72404612|NCT00654381|144316537|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-20.4|STANDARD_ERROR_OF_MEAN|2.9|<|0.0001|TWO_SIDED|95.0|-26.2|-14.7|||ANCOVA|Model includes treatment,baseline FPG, and number of previous antidiabetic medication||Linagliptin 10 mg vs placebo at week 12||-14.7|-26.2|<0.0001
72404613|NCT00654381|144316538|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-6.9|STANDARD_ERROR_OF_MEAN|3.1||0.0239|TWO_SIDED|95.0|-13.0|-0.9|||ANCOVA|Model includes treatment,baseline FPG, and number of previous antidiabetic medication||Linagliptin 5 mg vs Voglibose at week 26||-0.9|-13.0|0.0239
72404614|NCT00654381|144316538|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-9.8|STANDARD_ERROR_OF_MEAN|3.1||0.0015|TWO_SIDED|95.0|-15.8|-3.8|||ANCOVA|Model includes treatment,baseline FPG, and number of previous antidiabetic medication||Linagliptin 10 mg vs voglibose at week 26||-3.8|-15.8|0.0015
72404615|NCT02623803|144316552|SUPERIORITY|||||||0.1459|||||||Wilcoxon (Mann-Whitney)|||||||0.1459
72404616|NCT02623803|144316553|SUPERIORITY|||||||0.205|||||||Wilcoxon (Mann-Whitney)|||||||0.2050
72404617|NCT02623803|144316554|SUPERIORITY|||||||0.3989|||||||Wilcoxon (Mann-Whitney)|||||||0.3989
72404618|NCT02623803|144316555|SUPERIORITY|||||||0.5285|||||||Wilcoxon (Mann-Whitney)|||||||0.5285
72404619|NCT02623803|144316556|SUPERIORITY|||||||0.0697|||||||Wilcoxon (Mann-Whitney)|||||||0.0697
72404620|NCT02623803|144316557|SUPERIORITY|||||||0.1029|||||||Wilcoxon (Mann-Whitney)|||||||0.1029
72404621|NCT02623803|144316558|SUPERIORITY|||||||0.3136|||||||Wilcoxon (Mann-Whitney)|||||||0.3136
72404622|NCT02623803|144316559|SUPERIORITY|||||||0.2196|||||||Wilcoxon (Mann-Whitney)|||||||0.2196
72404623|NCT02623803|144316560|SUPERIORITY|||||||0.3057|||||||Wilcoxon (Mann-Whitney)|||||||0.3057
72404624|NCT02623803|144316561|SUPERIORITY|||||||0.0404|||||||Wilcoxon (Mann-Whitney)|||||||0.0404
72404625|NCT02623803|144316562|SUPERIORITY|||||||0.5314|||||||Wilcoxon (Mann-Whitney)|||||||0.5314
72404626|NCT02623803|144316563|SUPERIORITY|||||||0.3166|||||||Wilcoxon (Mann-Whitney)|||||||0.3166
72404627|NCT02623803|144316564|SUPERIORITY|||||||0.2363|||||||Wilcoxon (Mann-Whitney)|||||||0.2363
72404628|NCT02623803|144316565|SUPERIORITY|||||||0.9171|||||||Wilcoxon (Mann-Whitney)|||||||0.9171
72404629|NCT02623803|144316566|SUPERIORITY|||||||0.4194|||||||Wilcoxon (Mann-Whitney)|||||||0.4194
72404630|NCT02623803|144316567|SUPERIORITY|||||||0.7073|||||||Wilcoxon (Mann-Whitney)|||||||0.7073
72404631|NCT02623803|144316568|SUPERIORITY|||||||0.5107|||||||Wilcoxon (Mann-Whitney)|||||||0.5107
72404632|NCT02623803|144316569|SUPERIORITY|||||||0.8339|||||||Wilcoxon (Mann-Whitney)|||||||0.8339
72404633|NCT02623803|144316570|SUPERIORITY|||||||0.8927|||||||Wilcoxon (Mann-Whitney)|||||||0.8927
72624494|NCT02507934|144778687|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Iris - Right - Day 21±1||||1.0000
72624495|NCT02507934|144778687|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Iris - Left - Day 21±1||||1.0000
72404634|NCT01604343|144316580|SUPERIORITY_OR_OTHER||Percentage Difference|28.4|||<|0.001|TWO_SIDED|95.0|22.8|33.8|||Cochran-Mantel-Haenszel|||||33.8|22.8|< 0.001
72404635|NCT01604343|144316580|SUPERIORITY_OR_OTHER||Percentage Difference|27.1|||<|0.001|TWO_SIDED|95.0|21.6|32.6|||Cochran-Mantel-Haenszel|||||32.6|21.6|< 0.001
72404636|NCT01604343|144316581|SUPERIORITY_OR_OTHER||||||<|0.001|||||||van der waerden ANOVA|||||||< 0.001
72404637|NCT01604343|144316581|SUPERIORITY_OR_OTHER||||||<|0.001|||||||van der waerden ANOVA|||||||< 0.001
72404638|NCT01604343|144316582|SUPERIORITY_OR_OTHER||Least Square (LS) mean difference|-0.226|||<|0.001|TWO_SIDED|95.0|-0.29|-0.17|||ANCOVA|||||-0.17|-0.29|<0.001
72404639|NCT01604343|144316582|SUPERIORITY_OR_OTHER||LS mean difference|-0.256|||<|0.001|TWO_SIDED|95.0|-0.32|-0.2|||ANCOVA|||||-0.20|-0.32|<0.001
72404640|NCT01604343|144316583|SUPERIORITY_OR_OTHER||Percentage Difference|17.8|||<|0.001|TWO_SIDED|95.0|13.1|22.4|||Cochran-Mantel-Haenszel|||||22.4|13.1|< 0.001
72624496|NCT02507934|144778687|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Anterior chamber inflammation - Right - Day 21±1||||1.0000
72624497|NCT02507934|144778687|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Anterior chamber inflammation - Left - Day 21±1||||1.0000
72624498|NCT02507934|144778687|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Cornea transparency - Right - Day 21±1||||1.0000
72624499|NCT02507934|144778687|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Cornea transparency - Left - Day 21±1||||1.0000
72404641|NCT01604343|144316583|SUPERIORITY_OR_OTHER||Percentage Difference|20.8|||<|0.001|TWO_SIDED|95.0|16.1|25.6|||Cochran-Mantel-Haenszel|||||25.6|16.1|< 0.001
72404642|NCT01604343|144316584|SUPERIORITY_OR_OTHER||Percentage Difference|20.5|||<|0.001|TWO_SIDED|95.0|16.4|24.6|||Cochran-Mantel-Haenszel|||||24.6|16.4|< 0.001
72404643|NCT01604343|144316584|SUPERIORITY_OR_OTHER||Percentage Difference|19.9|||<|0.001|TWO_SIDED|95.0|15.8|24.0|||Cochran-Mantel-Haenszel|||||24.0|15.8|< 0.001
72404644|NCT01604343|144316585|SUPERIORITY_OR_OTHER||Percentage Difference|3.6||||0.001|TWO_SIDED|95.0|1.4|5.8|||Cochran-Mantel-Haenszel|||||5.8|1.4|0.001
72404645|NCT01604343|144316585|SUPERIORITY_OR_OTHER||Percentage Difference|7.2|||<|0.001|TWO_SIDED|95.0|4.6|9.8|||Cochran-Mantel-Haenszel|||||9.8|4.6|< 0.001
72404646|NCT03754959|144316667|OTHER||Ratio|97.9|||||TWO_SIDED|90.0|90.2|106.2|||||Ratio is calculated with Placebo+Midazolam on day 1 in the nominator and the Midazolam on day -1 in the denominator|The statistical model used for the analysis of the secondary endpoints was an ANOVA model on the logarithmic scale including 'treatment' ('midazolam' and 'midazolam + Placebo/BI') as fixed effect and 'subject' as random effect. The analysis was performed separately for Day 1 and Day 14.||106.2|90.2|
72404647|NCT03754959|144316667|OTHER||Ratio|95.9|||||TWO_SIDED|90.0|89.9|102.4|||||Ratio is calculated with BI 1358894 10 mg+Midazolam on day 1 in the nominator and the Midazolam on day -1 in the denominator.|||102.4|89.9|
72490489|NCT02605187|144508589|SUPERIORITY|||||||0.786|||||||ANOVA|||Comparison of nausea score 24 hours after delivery. Null Hypothesis: all means are equal||||0.786
72490490|NCT02605187|144508589|SUPERIORITY|||||||0.985|||||||ANOVA|||Comparison of nausea score at 48 hours after delivery. Null Hypothesis: all means are equal||||0.985
72490491|NCT02605187|144508590|SUPERIORITY|||||||0.057|||||||Chi-squared|||Comparison of participants who need nausea treatment from 0-24 hours after delivery.||||0.057
72490492|NCT02605187|144508590|SUPERIORITY|||||||0.246|||||||Fisher Exact|||Comparison of participants who need nausea treatment from 24-48 hours after delivery.||||0.246
72490493|NCT02605187|144508591|SUPERIORITY|||||||0.226|||||||ANOVA|||Comparison of average number of vomiting episodes 0-24 hours after delivery. Null Hypothesis: all means are equal||||0.226
72490494|NCT02605187|144508592|SUPERIORITY|||||||0.036|||||||ANOVA|||||||0.036
72490495|NCT02605187|144508593|SUPERIORITY|||||||0.019|||||||ANOVA|||Comparison of satisfaction with pain medication 24 hours after delivery.||||0.019
72490496|NCT02605187|144508593|SUPERIORITY|||||||0.873|||||||ANOVA|||Comparison of satisfaction with pain medication 48 hours after delivery.||||0.873
72490497|NCT05433571|144508594|SUPERIORITY|Superiority was tested for Senofilcon A (C3) Multifocal Toric lens with UV/HEV filter (Low DC) and concluded if the lower limit of a 95% confidence interval was above 0.80|Mean Population Estimate|0.917|STANDARD_ERROR_OF_MEAN|0.0194|||TWO_SIDED|95.0|0.878|0.955|||Bootstrapping Methods|bias adjusted confidence intervals||||0.955|0.878|
72490498|NCT05433571|144508594|SUPERIORITY|Superiority was tested for Senofilcon A (C3) Multifocal Toric lens with UV/HEV filter (High DC) and concluded if the lower limit of a 95% confidence interval was above 0.80|Mean Population Estimate|0.887|STANDARD_ERROR_OF_MEAN|0.0219|||TWO_SIDED|95.0|0.845|0.93|||Bootstrapping Methods|bias adjusted confidence intervals||||0.930|0.845|
72490499|NCT00940589|144508596|SUPERIORITY_OR_OTHER||||||<|0.045|TWO_SIDED||||||ANCOVA|||||||<0.045
72490500|NCT00940589|144508597|SUPERIORITY_OR_OTHER||||||<|0.044|TWO_SIDED||||||ANCOVA|||||||<0.044
72490501|NCT01918007|144508615|SUPERIORITY||Odds Ratio (OR)|1.3||||0.54|TWO_SIDED|95.0|0.5|3.3|||Chi-squared|||||3.3|0.5|0.54
72490502|NCT01918007|144508616|SUPERIORITY||Odds Ratio (OR)|14.0|||<|0.001|TWO_SIDED|95.0|2.9|68.4|||Chi-squared|||||68.4|2.9|<0.001
72490503|NCT01918007|144508617|SUPERIORITY||Mean Difference (Net)|-0.31|||<|0.001|TWO_SIDED|95.0|-0.35|-0.27|||t-test, 2 sided|||||-0.27|-0.35|<0.001
72490504|NCT01918007|144508618|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
72490505|NCT01918007|144508619|SUPERIORITY||Mean Difference (Net)|-2.76|||<|0.001|TWO_SIDED|95.0|-3.63|-1.9|||t-test, 2 sided|||||-1.90|-3.63|<0.001
72490506|NCT01918007|144508620|SUPERIORITY||Risk Ratio (RR)|1.16||||0.553|TWO_SIDED|95.0|0.71|1.89|||Chi-squared|||||1.89|0.71|0.553
72490507|NCT01918007|144508621|SUPERIORITY||Risk Ratio (RR)|1.79||||0.057|TWO_SIDED|95.0|0.98|3.27|||Chi-squared|||||3.27|0.98|0.057
72490508|NCT01918007|144508622|SUPERIORITY||Risk Ratio (RR)|2.29||||0.084|TWO_SIDED|95.0|0.84|6.25|||Chi-squared|||||6.25|0.84|0.084
72490509|NCT01918007|144508623|SUPERIORITY|||||||0.547|||||||Wilcoxon (Mann-Whitney)|||||||0.547
72490510|NCT01918007|144508624|SUPERIORITY|||||||0.062|||||||Wilcoxon (Mann-Whitney)|||||||0.062
72490511|NCT01918007|144508625|SUPERIORITY|||||||0.208|||||||Wilcoxon (Mann-Whitney)|||||||0.208
72490512|NCT01918007|144508626|SUPERIORITY|||||||0.585|||||||Wilcoxon (Mann-Whitney)|||||||0.585
72490513|NCT01918007|144508627|SUPERIORITY|||||||0.074|||||||Wilcoxon (Mann-Whitney)|||||||0.074
72624500|NCT02507934|144778687|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Cornea neovascularization - Right - Day 21±1||||1.0000
72624501|NCT02507934|144778687|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Cornea neovascularization - Left - Day 21±1||||1.0000
72624502|NCT02507934|144778688|SUPERIORITY||Mean Difference (Final Values)|1.12||||0.0599|TWO_SIDED|95.0|-0.05|2.29|||Student t-test for unpaired data|||T-test on changes from baseline in Intraocular pressure - Left eye - Day 7±1||2.29|-0.05|0.0599
72624503|NCT02507934|144778688|SUPERIORITY||Mean Difference (Final Values)|0.49||||0.3969|TWO_SIDED|95.0|-0.68|1.66|||Student t-test for unpaired data|||T-test on changes from baseline in Intraocular pressure - Right eye - Day 7±1||1.66|-0.68|0.3969
72624504|NCT02507934|144778688|SUPERIORITY||Mean Difference (Final Values)|0.28||||0.7225|TWO_SIDED|95.0|-1.29|1.84|||Student t-test for unpaired data|||T-test on changes from baseline in Intraocular pressure - Left eye - Day 14±1||1.84|-1.29|0.7225
72404648|NCT03754959|144316667|OTHER||Ratio|101.0|||||TWO_SIDED|90.0|96.3|106.1|||||Ratio is calculated with BI 1358894 25 mg+Midazolam on day 1 in the nominator and the Midazolam on day -1 in the denominator.|The statistical model used for the analysis of the secondary endpoints was an ANOVA model on the logarithmic scale including 'treatment' ('midazolam' and 'midazolam + Placebo/BI') as fixed effect and 'subject' as random effect. The analysis was performed separately for Day 1 and Day 14.||106.1|96.3|
72490514|NCT00960661|144508634|NON_INFERIORITY_OR_EQUIVALENCE|Non inferiority was concluded if the upper limit of the 95% confidence interval (CI) for the treatment contrast (BET minus BBT) at week 30 was less than the non inferiority margin.|Mean Difference (Final Values)|-0.04||||0.6273|TWO_SIDED|95.0|-0.18|0.11||The primary mixed-model repeated measures (MMRM) model included baseline HbA1c as covariate, treatment, country, prior use of SUs, week of visit, and treatment-by-week interaction as fixed effects and patient and error as random effects.|Mixed model repeated measures|||The primary objective is to test the hypothesis that BET is non inferior to BBT with respect to change in HbA1c from baseline to Week 30.||0.11|-0.18|0.6273
72490515|NCT03070470|144508651|OTHER|The appropriateness of the linear model will be assessed. Projected estimates will be computed only if the linear model is found acceptable.|Mean Difference (Final Values)|1.2|||||TWO_SIDED|90.0|-9.5|12.0||The degrees of freedom for the model estimates were determined by the Kenward-Rogers method as prespecified in the SAP.|Mixed Models Analysis|||Upper bound of the 2-sided 90% confidence interval (CI) to be \<10 msec for the projected placebo-corrected change from baseline J-Tpeakc effect at the peak plasma level on Day 3 using a linear mixed-effects exposure response model||12.0|-9.5|
72516691|NCT02528253|144564388|SUPERIORITY||Odds Ratio (OR)|1.74||||0.0007|TWO_SIDED|95.0|1.26|2.39|||Regression, Logistic|||Week 2, \>=30%: Odds ratio (OR) and 95% Confidence interval (CI) estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||2.39|1.26|0.0007
72624505|NCT02507934|144778688|SUPERIORITY||Mean Difference (Final Values)|-0.76||||0.269|TWO_SIDED|95.0|-2.14|0.62|||Student t-test for unpaired data|||T-test on changes from baseline in Intraocular pressure - Right eye - Day 14±1||0.62|-2.14|0.2690
72516692|NCT02528253|144564388|SUPERIORITY||Odds Ratio (OR)|1.77||||0.0004|TWO_SIDED|95.0|1.29|2.44|||Regression, Logistic|||Week 2, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||2.44|1.29|0.0004
72516693|NCT02528253|144564388|SUPERIORITY||Odds Ratio (OR)|1.14||||0.3456|TWO_SIDED|95.0|0.87|1.5|||Regression, Logistic|||Week 2, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.50|0.87|0.3456
72624506|NCT02507934|144778688|SUPERIORITY||Mean Difference (Final Values)|0.78||||0.2344|TWO_SIDED|95.0|-0.53|2.1|||Student t-test for unpaired data|||T-test on changes from baseline in Intraocular pressure - Left eye - Day 21±1||2.10|-0.53|0.2344
72624507|NCT02507934|144778688|SUPERIORITY||Mean Difference (Final Values)|0.47||||0.5953|TWO_SIDED|95.0|-1.3|2.24|||Student t-test for unpaired data|||T-test on changes from baseline in Intraocular pressure - Right eye||2.24|-1.30|0.5953
72624508|NCT02507934|144778689|SUPERIORITY||Mean Difference (Final Values)|0.79||||0.2193|TWO_SIDED|95.0|-0.54|2.11|||Student t-test for unpaired data|||T-test on number of daily administrations of IMD during the second week of the clinical investigation - Day 7||2.11|-0.54|0.2193
72490516|NCT03070470|144508651|OTHER|The appropriateness of the linear model will be assessed. Projected estimates will be computed only if the linear model is found acceptable.|Mean Difference (Final Values)|-2.6|||||TWO_SIDED|90.0|-11.4|6.1|||Mixed Models Analysis|The degrees of freedom for the model estimates were determined by the Kenward-Rogers method as prespecified in the SAP.||Upper bound of the 2-sided 90% confidence interval (CI) to be \<10 msec for the projected placebo-corrected change from baseline J-Tpeakc effect at the peak plasma level on Day 3 using a linear mixed-effects exposure response model||6.1|-11.4|
72516694|NCT02528253|144564388|SUPERIORITY||Odds Ratio (OR)|1.16||||0.2771|TWO_SIDED|95.0|0.89|1.53|||Regression, Logistic|||Week 2, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.53|0.89|0.2771
72490517|NCT03070470|144508651|OTHER|The appropriateness of the linear model will be assessed. Projected estimates will be computed only if the linear model is found acceptable.|Mean Difference (Final Values)|-2.9|||||TWO_SIDED|90.0|-14.6|8.8|||Mixed Models Analysis|The degrees of freedom for the model estimates were determined by the Kenward-Rogers method as prespecified in the SAP.||Upper bound of the 2-sided 90% confidence interval (CI) to be \<10 msec for the projected placebo-corrected change from baseline J-Tpeakc effect at the peak plasma level on Day 3 using a linear mixed-effects exposure response model||8.8|-14.6|
72490518|NCT03070470|144508652|OTHER|The appropriateness of the linear model will be assessed. Projected estimates will be computed only if the linear model is found acceptable.|Mean Difference (Final Values)|30.7|||||TWO_SIDED|90.0|22.6|38.9|||Mixed Models Analysis|The degrees of freedom for the model estimates were determined by the Kenward-Rogers method as prespecified in the SAP.||Upper bound of the 2-sided 90% CI to be ≥10 msec for the projected placebo-corrected change from baseline QTc effect at the peak plasma level on Day 1 using a linear mixed-effects exposure response model.||38.9|22.6|
72490519|NCT00530270|144508657|SUPERIORITY_OR_OTHER|||||||0.127||95.0||||A two-sided alpha of 0.05 was used. No multiple comparison adjustments were made.|Mixed Models Analysis|||The null hypothesis of no difference in the log duration of signs and symptoms or hospitalization between the two treatment groups was tested using an F test from a generalized mixed model with fixed effects for treatment group, age group and ACS severity. Please note that the study was stopped prematurely so only 11 of the 112 originally planned were included in the analysis.||||0.127
72490520|NCT00530270|144508658|SUPERIORITY_OR_OTHER|||||||0.801||||||A two-sided alpha of 0.05 was used. No multiple comparison adjustments were made.|Mixed Models Analysis|||The null hypothesis of no difference in the log duration of signs and symptoms or hospitalization between the two treatment groups was tested using an F test from a generalized mixed model with fixed effects for treatment group, age group and ACS severity. Please note that the study was stopped prematurely so only 11 of the 112 originally planned were included in the analysis.||||0.801
72516695|NCT02528253|144564388|SUPERIORITY||Odds Ratio (OR)|1.54||||0.0594|TWO_SIDED|95.0|0.98|2.41|||Regression, Logistic|||Week 2, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||2.41|0.98|0.0594
72516696|NCT02528253|144564388|SUPERIORITY||Odds Ratio (OR)|1.77||||0.0105|TWO_SIDED|95.0|1.14|2.75|||Regression, Logistic|||Week 2, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||2.75|1.14|0.0105
72516697|NCT02528253|144564388|SUPERIORITY||Odds Ratio (OR)|1.29||||0.236|TWO_SIDED|95.0|0.85|1.98|||Regression, Logistic|||Week 2, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.98|0.85|0.2360
72516698|NCT02528253|144564388|SUPERIORITY||Odds Ratio (OR)|1.19||||0.3746|TWO_SIDED|95.0|0.81|1.75|||Regression, Logistic|||Week 2, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.75|0.81|0.3746
72568671|NCT04168190|144668508|SUPERIORITY|Superiority can be concluded if the lower bound of the 95% CI for the estimated GMC ratio (V116/PPSV23) is \>1.0 (1-sided p-value \<0.025).|GMC Ratio|10.13|||<|0.001|TWO_SIDED|95.0|8.32|12.33|||P-value was estimated from a cLDA model.||Phase 2: V116/Phase 2: Pneumovax™23|Serotype 31. Geometric mean concentration (GMC) ratio, 95% confidence interval (CI), and p-value are estimated from a constrained longitudinal data analysis (cLDA) model.||12.33|8.32|<0.001
72516699|NCT02528253|144564388|SUPERIORITY||Odds Ratio (OR)|1.37||||0.0974|TWO_SIDED|95.0|0.94|1.99|||Regression, Logistic|||Week 2, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.99|0.94|0.0974
72516700|NCT02528253|144564388|SUPERIORITY||Odds Ratio (OR)|1.94||||0.0806|TWO_SIDED|95.0|0.92|4.08|||Regression, Logistic|||Week 2, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||4.08|0.92|0.0806
72516701|NCT02528253|144564388|SUPERIORITY||Odds Ratio (OR)|2.15||||0.0407|TWO_SIDED|95.0|1.03|4.47|||Regression, Logistic|||Week 2, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||4.47|1.03|0.0407
72568672|NCT04168190|144668508|SUPERIORITY|Superiority can be concluded if the lower bound of the 95% CI for the estimated GMC ratio (V116/PPSV23) is \>1.0 (1-sided p-value \<0.025).|GMC Ratio|18.29|||<|0.001|TWO_SIDED|95.0|15.59|21.45|||P-value is estimated from a cLDA model.||Phase 2: V116/Phase 2: Pneumovax™23|Serotype 35B. Geometric mean concentration (GMC) ratio, 95% confidence interval (CI), and p-value are estimated from a constrained longitudinal data analysis (cLDA) model.||21.45|15.59|<0.001
72568673|NCT02666352|144668518|OTHER||Geometric least-squares mean ratio|1.43|||||TWO_SIDED|90.0|0.89|2.31||||||||2.31|0.89|
72568674|NCT02666352|144668518|OTHER||Geometric least-squares mean ratio|2.15|||||TWO_SIDED|90.0|1.33|3.47||||||||3.47|1.33|
72568675|NCT02666352|144668519|OTHER||Geometric least-squares mean ratio|1.43|||||TWO_SIDED|90.0|0.88|2.31||||||||2.31|0.88|
72516702|NCT02528253|144564388|SUPERIORITY||Odds Ratio (OR)|1.22||||0.5966|TWO_SIDED|95.0|0.58|2.58|||Regression, Logistic|||Week 2, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||2.58|0.58|0.5966
72568676|NCT02666352|144668519|OTHER||Geometric least-squares mean ratio|2.15||||||90.0|1.33|3.48||||||||3.48|1.33|
72516703|NCT02528253|144564388|SUPERIORITY||Odds Ratio (OR)|1.59||||0.1492|TWO_SIDED|95.0|0.85|2.96|||Regression, Logistic|||Week 2, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||2.96|0.85|0.1492
72516704|NCT02528253|144564388|SUPERIORITY||Odds Ratio (OR)|1.76||||0.072|TWO_SIDED|95.0|0.95|3.24|||Regression, Logistic|||Week 2, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||3.24|0.95|0.0720
72516705|NCT02528253|144564388|SUPERIORITY||Odds Ratio (OR)|0.99||||0.9926|TWO_SIDED|95.0|0.25|4.0|||Regression, Logistic|||Week 2, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||4.00|0.25|0.9926
72516706|NCT02528253|144564388|SUPERIORITY||Odds Ratio (OR)|1.75||||0.3726|TWO_SIDED|95.0|0.51|6.04|||Regression, Logistic|||Week 2, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||6.04|0.51|0.3726
72516707|NCT02528253|144564388|SUPERIORITY||Odds Ratio (OR)|0.83||||0.7874|TWO_SIDED|95.0|0.22|3.12|||Regression, Logistic|||Week 2, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||3.12|0.22|0.7874
72516708|NCT02528253|144564388|SUPERIORITY||Odds Ratio (OR)|1.19||||0.795|TWO_SIDED|95.0|0.32|4.46|||Regression, Logistic|||Week 2, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||4.46|0.32|0.7950
72516709|NCT02528253|144564388|SUPERIORITY||Odds Ratio (OR)|2.1||||0.2065|TWO_SIDED|95.0|0.66|6.68|||Regression, Logistic|||Week 2, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||6.68|0.66|0.2065
72516710|NCT02528253|144564388|SUPERIORITY||Odds Ratio (OR)|1.64||||0.0006|TWO_SIDED|95.0|1.23|2.17|||Regression, Logistic|||Week 4, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||2.17|1.23|0.0006
72516711|NCT02528253|144564388|SUPERIORITY||Odds Ratio (OR)|2.05|||<|0.0001|TWO_SIDED|95.0|1.55|2.72|||Regression, Logistic|||Week 4, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||2.72|1.55|<.0001
72516712|NCT02528253|144564388|SUPERIORITY||Odds Ratio (OR)|1.32||||0.0387|TWO_SIDED|95.0|1.01|1.71|||Regression, Logistic|||Week 4, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.71|1.01|0.0387
72516713|NCT02528253|144564388|SUPERIORITY||Odds Ratio (OR)|1.24||||0.0903|TWO_SIDED|95.0|0.97|1.6|||Regression, Logistic|||Week 4, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.60|0.97|0.0903
72516714|NCT02528253|144564388|SUPERIORITY||Odds Ratio (OR)|1.56||||0.0006|TWO_SIDED|95.0|1.21|2.01|||Regression, Logistic|||Week 4, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||2.01|1.21|0.0006
72516715|NCT02528253|144564388|SUPERIORITY||Odds Ratio (OR)|1.5||||0.0166|TWO_SIDED|95.0|1.08|2.09|||Regression, Logistic|||Week 4, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||2.09|1.08|0.0166
72516716|NCT02528253|144564388|SUPERIORITY||Odds Ratio (OR)|1.89||||0.0001|TWO_SIDED|95.0|1.36|2.62|||Regression, Logistic|||Week 4, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||2.62|1.36|0.0001
72516717|NCT02528253|144564388|SUPERIORITY||Odds Ratio (OR)|1.27||||0.1389|TWO_SIDED|95.0|0.93|1.73|||Regression, Logistic|||Week 4, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.73|0.93|0.1389
72516718|NCT02528253|144564388|SUPERIORITY||Odds Ratio (OR)|1.19||||0.2504|TWO_SIDED|95.0|0.89|1.59|||Regression, Logistic|||Week 4, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.59|0.89|0.2504
72516719|NCT02528253|144564388|SUPERIORITY||Odds Ratio (OR)|1.49||||0.0057|TWO_SIDED|95.0|1.12|1.98|||Regression, Logistic|||Week 4, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.98|1.12|0.0057
72516720|NCT02528253|144564388|SUPERIORITY||Odds Ratio (OR)|1.83||||0.0126|TWO_SIDED|95.0|1.14|2.93|||Regression, Logistic|||Week 4, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||2.93|1.14|0.0126
72568677|NCT02666352|144668520|OTHER||Geometric least-squares mean ratio|1.43|||||TWO_SIDED|90.0|0.89|2.31||||||||2.31|0.89|
72568678|NCT02666352|144668520|OTHER||Geometric least-squares mean ratio|2.15|||||TWO_SIDED|90.0|1.33|3.47||||||||3.47|1.33|
72568679|NCT02666352|144668521|OTHER||Geometric least-squares mean ratio|1.32|||||TWO_SIDED|90.0|0.81|2.15||||||||2.15|0.81|
72568680|NCT02666352|144668521|OTHER||Geometric least-squares mean ratio|1.81|||||TWO_SIDED|90.0|1.11|2.94||||||||2.94|1.11|
72568681|NCT02666352|144668527|OTHER||Geometric least-squares mean ratio|0.8|||||TWO_SIDED|90.0|0.58|1.1||||||||1.10|0.58|
72568682|NCT02666352|144668527|OTHER||Geometric least-squares mean ratio|0.84|||||TWO_SIDED|90.0|0.61|1.16||||||||1.16|0.61|
72568683|NCT02666352|144668528|OTHER||Geometric least-squares mean ratio|0.8|||||TWO_SIDED|90.0|0.58|1.11||||||||1.11|0.58|
72568684|NCT02666352|144668528|OTHER||Geometric least-squares mean ratio|0.86||||||90.0|0.62|1.18||||||||1.18|0.62|
72568685|NCT02666352|144668529|OTHER||Geometric least-squares mean ratio|0.77|||||TWO_SIDED|90.0|0.57|1.05||||||||1.05|0.57|
72568686|NCT02666352|144668529|OTHER||Geometric least-squares mean ratio|0.73|||||TWO_SIDED|90.0|0.54|0.99||||||||0.99|0.54|
72490521|NCT00530270|144508659|SUPERIORITY_OR_OTHER|||||||0.02||95.0||||A two-sided alpha of 0.05 was used. No multiple comparison adjustments were made.|Mixed Models Analysis|Different error variance estimates were allowed for the two treatment groups.||The null hypothesis of no difference in the log duration of signs and symptoms or hospitalization between the two treatment groups was tested using an F test from a generalized mixed model with fixed effects for treatment group, age group and ACS severity. Please note that the study was stopped prematurely so only 11 of the 112 originally planned were included in the analysis.||||0.02
72490522|NCT00530270|144508660|SUPERIORITY_OR_OTHER|||||||0.876||95.0||||A two-sided alpha of 0.05 was used. No multiple comparison adjustments were made.|Mixed Models Analysis|Different error variance estimates were allowed for the two treatment groups.||The null hypothesis of no difference in the log duration of signs and symptoms or hospitalization between the two treatment groups was tested using an F test from a generalized mixed model with fixed effects for treatment group, age group and ACS severity. Please note that the study was stopped prematurely so only 11 of the 112 originally planned were included in the analysis.||||0.876
72516721|NCT02528253|144564388|SUPERIORITY||Odds Ratio (OR)|2.69|||<|0.0001|TWO_SIDED|95.0|1.71|4.22|||Regression, Logistic|||Week 4, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||4.22|1.71|<.0001
72516722|NCT02528253|144564388|SUPERIORITY||Odds Ratio (OR)|1.25||||0.3485|TWO_SIDED|95.0|0.79|1.99|||Regression, Logistic|||Week 4, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.99|0.79|0.3485
72516723|NCT02528253|144564388|SUPERIORITY||Odds Ratio (OR)|1.46||||0.0642|TWO_SIDED|95.0|0.98|2.19|||Regression, Logistic|||Week 4, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||2.19|0.98|0.0642
72404649|NCT03754959|144316667|OTHER||Ratio|93.7|||||TWO_SIDED|90.0|86.8|101.1|||||Ratio is calculated with BI 1358894 50 mg+Midazolam on day 1 in the nominator and the Midazolam on day -1 in the denominator.|The statistical model used for the analysis of the secondary endpoints was an ANOVA model on the logarithmic scale including 'treatment' ('midazolam' and 'midazolam + Placebo/BI') as fixed effect and 'subject' as random effect. The analysis was performed separately for Day 1 and Day 14.||101.1|86.8|
72404650|NCT03754959|144316667|OTHER||Ratio|93.1|||||TWO_SIDED|90.0|87.3|99.3|||||Ratio is calculated with BI 1358894 100 mg+Midazolam on day 1 in the nominator and the Midazolam on day -1 in the denominator.|The statistical model used for the analysis of the secondary endpoints was an ANOVA model on the logarithmic scale including 'treatment' ('midazolam' and 'midazolam + Placebo/BI') as fixed effect and 'subject' as random effect. The analysis was performed separately for Day 1 and Day 14.||99.3|87.3|
72516724|NCT02528253|144564388|SUPERIORITY||Odds Ratio (OR)|2.16|||<|0.0001|TWO_SIDED|95.0|1.48|3.14|||Regression, Logistic|||Week 4, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||3.14|1.48|<.0001
72516725|NCT02528253|144564388|SUPERIORITY||Odds Ratio (OR)|0.99||||0.9819|TWO_SIDED|95.0|0.42|2.31|||Regression, Logistic|||Week 4, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||2.31|0.42|0.9819
72516726|NCT02528253|144564388|SUPERIORITY||Odds Ratio (OR)|1.37||||0.4333|TWO_SIDED|95.0|0.62|3.02|||Regression, Logistic|||Week 4, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||3.02|0.62|0.4333
72490523|NCT00530270|144508661|SUPERIORITY_OR_OTHER|||||||0.77||95.0||||A two-sided alpha of 0.05 was used. No multiple comparison adjustments were made.|Mixed Models Analysis|Different error variance estimates were allowed for the two treatment groups.||The null hypothesis of no difference in the log duration of signs and symptoms or hospitalization between the two treatment groups was tested using an F test from a generalized mixed model with fixed effects for treatment group, age group and ACS severity. Please note that the study was stopped prematurely so only 11 of the 112 originally planned were included in the analysis.||||0.770
72516727|NCT02528253|144564388|SUPERIORITY||Odds Ratio (OR)|0.91||||0.814|TWO_SIDED|95.0|0.41|2.0|||Regression, Logistic|||Week 4, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||2.00|0.41|0.8140
72516728|NCT02528253|144564388|SUPERIORITY||Odds Ratio (OR)|1.09||||0.8331|TWO_SIDED|95.0|0.49|2.4|||Regression, Logistic|||Week 4, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||2.40|0.49|0.8331
72516729|NCT02528253|144564388|SUPERIORITY||Odds Ratio (OR)|1.51||||0.2682|TWO_SIDED|95.0|0.73|3.12|||Regression, Logistic|||Week 4, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||3.12|0.73|0.2682
72516730|NCT02528253|144564388|SUPERIORITY||Odds Ratio (OR)|1.73||||0.0001|TWO_SIDED|95.0|1.31|2.29|||Regression, Logistic|||Week 8, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||2.29|1.31|0.0001
72516731|NCT02528253|144564388|SUPERIORITY||Odds Ratio (OR)|1.97|||<|0.0001|TWO_SIDED|95.0|1.49|2.61|||Regression, Logistic|||Week 8, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||2.61|1.49|<.0001
72568687|NCT02666352|144668530|OTHER||Geometric least-squares mean ratio|0.83|||||TWO_SIDED|90.0|0.61|1.13||||||||1.13|0.61|
72568688|NCT02666352|144668530|OTHER||Geometric least-squares mean ratio|0.75|||||TWO_SIDED|90.0|0.55|1.01||||||||1.01|0.55|
72568689|NCT02666352|144668531|OTHER||Geometric least-squares mean ratio|0.83|||||TWO_SIDED|90.0|0.6|1.15||||||||1.15|0.60|
72568690|NCT02666352|144668531|OTHER||Geometric least-squares mean ratio|0.82|||||TWO_SIDED|90.0|0.59|1.13||||||||1.13|0.59|
72568691|NCT02666352|144668535|OTHER||Geometric least-squares mean ratio|0.68|||||TWO_SIDED|90.0|0.52|0.9||||||||0.90|0.52|
72568692|NCT02666352|144668535|OTHER||Geometric least-squares mean ratio|0.66|||||TWO_SIDED|90.0|0.5|0.86||||||||0.86|0.50|
72568693|NCT02666352|144668536|OTHER||Geometric least-squares mean ratio|0.64|||||TWO_SIDED|90.0|0.48|0.86||||||||0.86|0.48|
72568694|NCT02666352|144668536|OTHER||Geometric least-squares mean ratio|0.61||||||90.0|0.46|0.82||||||||0.82|0.46|
72568695|NCT02666352|144668537|OTHER||Geometric least-squares mean ratio|0.79|||||TWO_SIDED|90.0|0.62|1.01||||||||1.01|0.62|
72624509|NCT02507934|144778689|SUPERIORITY||Mean Difference (Final Values)|1.34||||0.0024|TWO_SIDED|95.0|0.51|2.18|||Student t-test for unpaired data|||T-test on number of daily administrations of IMD during the second week of the clinical investigation - Day 8||2.18|0.51|0.0024
72624510|NCT02507934|144778689|SUPERIORITY||Mean Difference (Final Values)|0.33||||0.425|TWO_SIDED|95.0|-0.49|1.14|||Student t-test for unpaired data|||T-test on number of daily administrations of IMD during the second week of the clinical investigation - Day 9||1.14|-0.49|0.4250
72568696|NCT02666352|144668537|OTHER||Geometric least-squares mean ratio|0.8|||||TWO_SIDED|90.0|0.63|1.02||||||||1.02|0.63|
72568697|NCT02666352|144668538|OTHER||Geometric least-squares mean ratio|0.8|||||TWO_SIDED|90.0|0.61|1.05||||||||1.05|0.61|
72568698|NCT02666352|144668538|OTHER||Geometric least-squares mean ratio|0.78|||||TWO_SIDED|90.0|0.6|1.03||||||||1.03|0.60|
72568699|NCT02666352|144668539|OTHER||Geometric least-squares mean ratio|0.71|||||TWO_SIDED|90.0|0.57|0.89||||||||0.89|0.57|
72568700|NCT02666352|144668539|OTHER||Geometric least-squares mean ratio|0.73|||||TWO_SIDED|90.0|0.58|0.91||||||||0.91|0.58|
72568701|NCT02666352|144668542|OTHER||Geometric least-squares mean ratio (GMR)|1.16|||||TWO_SIDED|90.0|0.85|1.58||||||||1.58|0.85|
72568702|NCT02666352|144668542|OTHER||Geometric least-squares mean ratio|1.36|||||TWO_SIDED|90.0|1.0|1.85||||||||1.85|1.00|
72568703|NCT02666352|144668543|OTHER||Geometric least-squares mean ratio|1.24|||||TWO_SIDED|90.0|0.91|1.68||||||||1.68|0.91|
72568704|NCT02666352|144668543|OTHER||Geometric least-squares mean ratio|1.58||||||90.0|1.17|2.14||||||||2.14|1.17|
72568705|NCT02666352|144668544|OTHER||Geometric least-squares mean ratio|0.89|||||TWO_SIDED|90.0|0.6|1.33||||||||1.33|0.60|
72568706|NCT02666352|144668544|OTHER||Geometric least-squares mean ratio|0.9|||||TWO_SIDED|90.0|0.6|1.34||||||||1.34|0.60|
72568707|NCT02666352|144668545|OTHER||Geometric least-squares mean ratio|0.77|||||TWO_SIDED|90.0|0.45|1.3||||||||1.30|0.45|
72568708|NCT02666352|144668545|OTHER||Geometric least-squares mean ratio|0.68|||||TWO_SIDED|90.0|0.4|1.14||||||||1.14|0.40|
72568709|NCT02666352|144668546|OTHER||Geometric least-squares mean ratio|1.2|||||TWO_SIDED|90.0|0.9|1.6||||||||1.60|0.90|
72568710|NCT02666352|144668546|OTHER||Geometric least-squares mean ratio|1.41|||||TWO_SIDED|90.0|1.06|1.87||||||||1.87|1.06|
72568711|NCT03979820|144668563|OTHER||Ratio of geometric mean TSFs|544.36|STANDARD_ERROR_OF_MEAN|1.32|||TWO_SIDED|90.0|340.57|870.09|||ANOVA||"The arm Phenelzine/Phenelzine + Tyramine represented the numerator. The arm Placebo/Placebo + Tyramine represented the denominator."|"The statistical model used for the analysis of the primary endpoint was an analysis of variance (ANOVA) model on the logarithmic scale for each treatment relative to placebo.~TSF was log-transformed (natural logarithm) prior to fitting the ANOVA model. The model included the fixed effects 'treatment'."||870.09|340.57|
72568712|NCT03979820|144668563|OTHER||Ratio of geometric mean TSFs|123.22|STANDARD_ERROR_OF_MEAN|1.32|||TWO_SIDED|90.0|77.09|196.95|||ANOVA||"The arm 10 mg BI 1467335/10 mg BI 1467335 + Tyramine represented the numerator.~The arm Placebo/Placebo + Tyramine represented the denominator."|"The statistical model used for the analysis of the primary endpoint was an analysis of variance (ANOVA) model on the logarithmic scale for each treatment relative to placebo.~TSF was log-transformed (natural logarithm) prior to fitting the ANOVA model. The model included the fixed effects 'treatment'."||196.95|77.09|
72568713|NCT01144364|144668579|SUPERIORITY_OR_OTHER|||||||0.254|||||||Log Rank|||Difference between treatment arms||||0.254
72568714|NCT01144364|144668581|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.58||||0.105|TWO_SIDED|95.0|0.31|1.12||Overall DFS|Cox proportional-hazards|Adjusted for randomization stratum and the known prognostic factors.||||1.12|0.31|0.105
72568715|NCT01144364|144668582|SUPERIORITY_OR_OTHER|||||||0.751|||||||Log Rank|||||||0.751
72568716|NCT01144364|144668583|SUPERIORITY_OR_OTHER|||||||0.751|||||||Log Rank|||||||0.751
72568717|NCT01144364|144668585|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.63||||0.079|TWO_SIDED|95.0|0.38|1.05|||Cox proportional-hazards|||Analysis of overall PFS with Cox proportional-hazards model adjusted for the randomization stratum and the known prognostic factors.||1.05|0.38|0.079
72568718|NCT01144364|144668588|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.66||||0.103|TWO_SIDED|95.0|0.4|1.09||Univariate analysis|Regression, Cox|Cox model stratified for the stratification groups.||||1.09|0.40|0.103
72568719|NCT01144364|144668588|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.62||||0.071|TWO_SIDED|95.0|0.37|1.04||Multivariate analysis|Regression, Cox|Adjusted for stratification group, age, sex, Eastern Cooperative Oncology Group Performance Status, FL International prognostic index (FLIPI) score.||||1.04|0.37|0.071
72624511|NCT02507934|144778689|SUPERIORITY||Mean Difference (Final Values)|0.56||||0.1275|TWO_SIDED|95.0|-0.17|1.29|||Student t-test for unpaired data|||T-test on number of daily administrations of IMD during the second week of the clinical investigation - Day 10||1.29|-0.17|0.1275
72624512|NCT02507934|144778689|SUPERIORITY||Mean Difference (Final Values)|0.66||||0.0844|TWO_SIDED|95.0|-0.09|1.42|||Student t-test for unpaired data|||T-test on number of daily administrations of IMD during the second week of the clinical investigation - Day 11||1.42|-0.09|0.0844
72624513|NCT02507934|144778689|SUPERIORITY||Mean Difference (Final Values)|0.86||||0.0238|TWO_SIDED|95.0|0.12|1.6|||Student t-test for unpaired data|||T-test on number of daily administrations of IMD during the second week of the clinical investigation - Day 12||1.60|0.12|0.0238
72624514|NCT02507934|144778689|SUPERIORITY||Mean Difference (Final Values)|0.83||||0.0369|TWO_SIDED|95.0|0.05|1.61|||Student t-test for unpaired data|||T-test on number of daily administrations of IMD during the second week of the clinical investigation - Day 13||1.61|0.05|0.0369
72404651|NCT03754959|144316667|OTHER||Ratio|90.0|||||TWO_SIDED|90.0|83.8|96.7|||||Ratio is calculated with BI 1358894 200 mg+Midazolam on day 1 in the nominator and the Midazolam on day -1 in the denominator.|The statistical model used for the analysis of the secondary endpoints was an ANOVA model on the logarithmic scale including 'treatment' ('midazolam' and 'midazolam + Placebo/BI') as fixed effect and 'subject' as random effect. The analysis was performed separately for Day 1 and Day 14.||96.7|83.8|
72516732|NCT02528253|144564388|SUPERIORITY||Odds Ratio (OR)|1.42||||0.0071|TWO_SIDED|95.0|1.1|1.83|||Regression, Logistic|||Week 8, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.83|1.10|0.0071
72404652|NCT03754959|144316668|OTHER||Ratio|105.7|||||TWO_SIDED|90.0|95.6|116.9|||||Ratio is calculated with Placebo+Midazolam on day 14 in the nominator and the Midazolam on day -1 in the denominator|The statistical model used for the analysis of the secondary endpoints was an ANOVA model on the logarithmic scale including 'treatment' ('midazolam' and 'midazolam + Placebo/BI') as fixed effect and 'subject' as random effect. The analysis was performed separately for Day 1 and Day 14.||116.9|95.6|
72516733|NCT02528253|144564388|SUPERIORITY||Odds Ratio (OR)|1.22||||0.1187|TWO_SIDED|95.0|0.95|1.57|||Regression, Logistic|||Week 8, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.57|0.95|0.1187
72516734|NCT02528253|144564388|SUPERIORITY||Odds Ratio (OR)|1.39||||0.011|TWO_SIDED|95.0|1.08|1.79|||Regression, Logistic|||Week 8, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.79|1.08|0.0110
72516735|NCT02528253|144564388|SUPERIORITY||Odds Ratio (OR)|1.76||||0.0003|TWO_SIDED|95.0|1.3|2.39|||Regression, Logistic|||Week 8, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||2.39|1.30|0.0003
72516736|NCT02528253|144564388|SUPERIORITY||Odds Ratio (OR)|2.12|||<|0.0001|TWO_SIDED|95.0|1.57|2.87|||Regression, Logistic|||Week 8, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||2.87|1.57|<.0001
72516737|NCT02528253|144564388|SUPERIORITY||Odds Ratio (OR)|1.48||||0.0069|TWO_SIDED|95.0|1.11|1.97|||Regression, Logistic|||Week 8, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.97|1.11|0.0069
72516738|NCT02528253|144564388|SUPERIORITY||Odds Ratio (OR)|1.19||||0.2076|TWO_SIDED|95.0|0.91|1.55|||Regression, Logistic|||Week 8, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.55|0.91|0.2076
72516739|NCT02528253|144564388|SUPERIORITY||Odds Ratio (OR)|1.43||||0.0072|TWO_SIDED|95.0|1.1|1.86|||Regression, Logistic|||Week 8, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.86|1.10|0.0072
72516740|NCT02528253|144564388|SUPERIORITY||Odds Ratio (OR)|1.47||||0.0694|TWO_SIDED|95.0|0.97|2.22|||Regression, Logistic|||Week 8, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||2.22|0.97|0.0694
72516741|NCT02528253|144564388|SUPERIORITY||Odds Ratio (OR)|2.27|||<|0.0001|TWO_SIDED|95.0|1.53|3.36|||Regression, Logistic|||Week 8, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||3.36|1.53|<.0001
72516742|NCT02528253|144564388|SUPERIORITY||Odds Ratio (OR)|1.36||||0.121|TWO_SIDED|95.0|0.92|2.0|||Regression, Logistic|||Week 8, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||2.00|0.92|0.1210
72516743|NCT02528253|144564388|SUPERIORITY||Odds Ratio (OR)|1.08||||0.6706|TWO_SIDED|95.0|0.76|1.54|||Regression, Logistic|||Week 8, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.54|0.76|0.6706
72624515|NCT02507934|144778689|SUPERIORITY||Mean Difference (Final Values)|0.52||||0.3496|TWO_SIDED|95.0|-0.61|1.64|||Student t-test for unpaired data|||T-test on number of daily administrations of IMD during the second week of the clinical investigation - Day 14||1.64|-0.61|0.3496
72624516|NCT02947048|144778694|SUPERIORITY||Mean Difference (Final Values)|-0.22|STANDARD_ERROR_OF_MEAN|0.42||0.61|TWO_SIDED||||||ANCOVA|||Clinical Global Impression - Severity||||0.61
72624517|NCT02947048|144778694|SUPERIORITY||Mean Difference (Final Values)|-0.53|STANDARD_ERROR_OF_MEAN|0.52||0.33|TWO_SIDED||||||ANCOVA|||Clinical Global Impression - Severity||||0.33
72490524|NCT02324920|144508663|SUPERIORITY||Hazard Ratio (HR)|0.22|||<|0.001|TWO_SIDED|95.0|0.11|0.46|||Regression, Cox||||Additional models were implemented to control for country and investigational sites effect on primary endpoint.|0.46|0.11|<0.001
72490525|NCT02324920|144508664|SUPERIORITY||Hazard Ratio (HR)|0.45||||0.002|TWO_SIDED|95.0|0.27|0.75|||Regression, Cox|||||0.75|0.27|0.002
72490526|NCT02919436|144508666|SUPERIORITY|We found observed rate of postoperative urinary retention in male spine surgery patients to historically be 17%. We hypothesize that the use of tamsulosin can reduce this rate by 50%. A two group continuity corrected chi-square test with a .05 two-sided significance level will have 80% power to detect the difference between a control group proportion of .17 and a treatment group proportion of .085 (odds ratio of .454) when the sample size in each group is 264 and a total sample size of 528.||||||0.96|||||||Chi-squared, Corrected|||||||.96
72490527|NCT03699007|144508669|SUPERIORITY||||||<|0.05|||||||Mixed Models Analysis|||||||<0.05
72516744|NCT02528253|144564388|SUPERIORITY||Odds Ratio (OR)|1.67||||0.0022|TWO_SIDED|95.0|1.2|2.32|||Regression, Logistic|||Week 8, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||2.32|1.20|0.0022
72490528|NCT03699007|144508670|SUPERIORITY||||||<|0.05|||||||Mixed Models Analysis|||||||<0.05
72490529|NCT03259074|144508671|SUPERIORITY||Marginal difference|1.51||||0.7164|TWO_SIDED|95.0|-6.63|9.64||Logistic regression model with treatment as a factor and baseline mSASSS score as a covariate using marginal standardization method.|Regression, Logistic|||||9.64|-6.63|0.7164
72516745|NCT02528253|144564388|SUPERIORITY||Odds Ratio (OR)|1.12||||0.7546|TWO_SIDED|95.0|0.56|2.22|||Regression, Logistic|||Week 8, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||2.22|0.56|0.7546
72516746|NCT02528253|144564388|SUPERIORITY||Odds Ratio (OR)|1.13||||0.7347|TWO_SIDED|95.0|0.57|2.24|||Regression, Logistic|||Week 8, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||2.24|0.57|0.7347
72516747|NCT02528253|144564388|SUPERIORITY||Odds Ratio (OR)|0.96||||0.9029|TWO_SIDED|95.0|0.5|1.84|||Regression, Logistic|||Week 8, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.84|0.50|0.9029
72490530|NCT03259074|144508671|SUPERIORITY||Marginal difference|1.67||||0.6925|TWO_SIDED|95.0|-6.61|9.95|||Regression, Logistic|Logistic regression model with treatment as a factor and baseline mSASSS score as a covariate using marginal standardization method.||||9.95|-6.61|0.6925
72490531|NCT03259074|144508672|SUPERIORITY|Due to to the pre-defined hierarchical testing strategy, p values beyond the primary endpoint which was not met were not presented.|LS mean difference|-0.18|||||TWO_SIDED|95.0|-0.646|0.293|||||ANCOVA model with treatment as a factor and baseline mSASSS score as a covariate.|||0.293|-0.646|
72490532|NCT03259074|144508672|SUPERIORITY|Due to to the pre-defined hierarchical testing strategy, p values beyond the primary endpoint which was not met were not presented.|LS mean difference|-0.16|||||TWO_SIDED|95.0|-0.639|0.315|||||ANCOVA model with treatment as a factor and baseline mSASSS score as a covariate.|||0.315|-0.639|
72490533|NCT03259074|144508673|SUPERIORITY|Due to to the pre-defined hierarchical testing strategy, p values beyond the primary endpoint which was not met were not presented.|Marginal difference|4.32|||||TWO_SIDED|95.0|-5.62|14.27|||||Logistic regression model with treatment as a factor and baseline count of vertebral corners with syndesmophyte as a covariate using marginal standardization method.|||14.27|-5.62|
72490534|NCT03259074|144508673|SUPERIORITY|Due to to the pre-defined hierarchical testing strategy, p values beyond the primary endpoint which was not met were not presented.|Marginal difference|1.09|||||TWO_SIDED|95.0|-9.13|11.31|||||Logistic regression model with treatment as a factor and baseline count of vertebral corners with syndesmophyte as a covariate using marginal standardization method.|||11.31|-9.13|
72516748|NCT02528253|144564388|SUPERIORITY||Odds Ratio (OR)|1.16||||0.6402|TWO_SIDED|95.0|0.62|2.18|||Regression, Logistic|||Week 8, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||2.18|0.62|0.6402
72516749|NCT02528253|144564388|SUPERIORITY||Odds Ratio (OR)|1.17||||0.6199|TWO_SIDED|95.0|0.62|2.2|||Regression, Logistic|||Week 8, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||2.20|0.62|0.6199
72490535|NCT03259074|144508674|OTHER|Due to to the pre-defined hierarchical testing strategy, p values beyond the primary endpoint which was not met were not presented.|LS Means|0.183|STANDARD_ERROR_OF_MEAN|0.1517|||TWO_SIDED|95.0|-0.12|0.48|||||LS Means and 95% CI are from an ANCOVA model with treatment as a factor, baseline Berlin SI joint edema score as a covariate.|Week 104 - 150 mg||0.48|-0.12|
72490536|NCT03259074|144508674|OTHER|Due to to the pre-defined hierarchical testing strategy, p values beyond the primary endpoint which was not met were not presented|LS Means|0.332|STANDARD_ERROR_OF_MEAN|0.1545|||TWO_SIDED|95.0|0.03|0.64|||||LS Means and 95% CI are from an ANCOVA model with treatment as a factor, baseline Berlin SI joint edema score as a covariate.|Week 104 - 300 mg||0.64|0.03|
72490537|NCT03259074|144508675|OTHER|Due to to the pre-defined hierarchical testing strategy, p values beyond the primary endpoint which was not met were not presented.|LS Means|0.877|STANDARD_ERROR_OF_MEAN|0.3316|||TWO_SIDED|95.0|0.22|1.53|||||LS Means and 95% CI are from an ANCOVA model with treatment as a factor, baseline Berlin SI joint edema score as a covariate.|Week 104 - 150 mg||1.53|0.22|
72490538|NCT03259074|144508675|OTHER|Due to to the pre-defined hierarchical testing strategy, p values beyond the primary endpoint which was not met were not presented|LS Means|0.419|STANDARD_ERROR_OF_MEAN|0.3357|||TWO_SIDED|95.0|-0.24|1.08|||||LS Means and 95% CI are from an ANCOVA model with treatment as a factor, baseline Berlin SI joint edema score as a covariate.|Week 104 - 300 mg||1.08|-0.24|
72490539|NCT03259074|144508676|OTHER|Due to to the pre-defined hierarchical testing strategy, p values beyond the primary endpoint which was not met were not presented.|Marginal difference|1.54|||||TWO_SIDED|95.0|-5.1|8.18|||||Estimated mean, marginal difference and 95% confidence interval are from a logistic regression model with treatment as a factor using marginal standardization method|||8.18|-5.10|
72404653|NCT03754959|144316668|OTHER||Ratio|117.5|||||TWO_SIDED|90.0|106.5|129.6|||||Ratio is calculated with BI 1358894 10 mg+Midazolam on day 14 in the nominator and the Midazolam on day -1 in the denominator.|The statistical model used for the analysis of the secondary endpoints was an ANOVA model on the logarithmic scale including 'treatment' ('midazolam' and 'midazolam + Placebo/BI') as fixed effect and 'subject' as random effect. The analysis was performed separately for Day 1 and Day 14.||129.6|106.5|
72404654|NCT03754959|144316668|OTHER||Ratio|112.6|||||TWO_SIDED|90.0|102.9|123.1|||||Ratio is calculated with BI 1358894 25 mg+Midazolam on day 14 in the nominator and the Midazolam on day -1 in the denominator.|The statistical model used for the analysis of the secondary endpoints was an ANOVA model on the logarithmic scale including 'treatment' ('midazolam' and 'midazolam + Placebo/BI') as fixed effect and 'subject' as random effect. The analysis was performed separately for Day 1 and Day 14.||123.1|102.9|
72404655|NCT03754959|144316668|OTHER||Ratio|110.3|||||TWO_SIDED|90.0|90.1|135.1|||||Ratio is calculated with BI 1358894 50 mg+Midazolam on day 14 in the nominator and the Midazolam on day -1 in the denominator.|The statistical model used for the analysis of the secondary endpoints was an ANOVA model on the logarithmic scale including 'treatment' ('midazolam' and 'midazolam + Placebo/BI') as fixed effect and 'subject' as random effect. The analysis was performed separately for Day 1 and Day 14.||135.1|90.1|
72404656|NCT03754959|144316668|OTHER||Ratio|96.4|||||TWO_SIDED|90.0|84.5|110.1|||||Ratio is calculated with BI 1358894 100 mg+Midazolam on day 14 in the nominator and the Midazolam on day -1 in the denominator.|The statistical model used for the analysis of the secondary endpoints was an ANOVA model on the logarithmic scale including 'treatment' ('midazolam' and 'midazolam + Placebo/BI') as fixed effect and 'subject' as random effect. The analysis was performed separately for Day 1 and Day 14.||110.1|84.5|
72404657|NCT03754959|144316668|OTHER||Ratio|89.3|||||TWO_SIDED|90.0|74.9|106.4|||||Ratio is calculated with BI 1358894 200 mg+Midazolam on day 14 in the nominator and the Midazolam on day -1 in the denominator.|The statistical model used for the analysis of the secondary endpoints was an ANOVA model on the logarithmic scale including 'treatment' ('midazolam' and 'midazolam + Placebo/BI') as fixed effect and 'subject' as random effect. The analysis was performed separately for Day 1 and Day 14.||106.4|74.9|
72404658|NCT03754959|144316669|OTHER||Ratio|98.3|||||TWO_SIDED|90.0|84.2|114.8|||||Ratio is calculated with Placebo+Midazolam on day 1 in the nominator and the Midazolam on day -1 in the denominator.|The statistical model used for the analysis of the secondary endpoints was an ANOVA mode lon the logarithmic scale including 'treatment' ('midazolam' and 'midazolam + Placebo/BI') as fixed effect and 'subject' as random effect. The analysis was performed separately for Day 1 and Day 14.||114.8|84.2|
72490540|NCT03259074|144508677|OTHER|Due to to the pre-defined hierarchical testing strategy, p values beyond the primary endpoint which was not met were not presented.|Marginal difference|-2.34|||||TWO_SIDED|95.0|-10.18|5.51|||||Estimated mean, marginal difference and 95% confidence interval are from a logistic regression model with treatment as a factor using marginal standardization method.|||5.51|-10.18|
72404659|NCT03754959|144316669|OTHER||Ratio|98.0|||||TWO_SIDED|90.0|87.9|109.3|||||Ratio is calculated with BI 1358894 10mg +Midazolam on day 1 in the nominator and the Midazolam on day -1 in the denominator.|The statistical model used for the analysis of the secondary endpoints was an ANOVA mode lon the logarithmic scale including 'treatment' ('midazolam' and 'midazolam + Placebo/BI') as fixed effect and 'subject' as random effect. The analysis was performed separately for Day 1 and Day 14.||109.3|87.9|
72404660|NCT03754959|144316669|OTHER||Ratio|117.5|||||TWO_SIDED|90.0|102.6|134.6|||||Ratio is calculated with BI 1358894 25 mg+Midazolam on day 1 in the nominator and the Midazolam on day -1 in the denominator.|The statistical model used for the analysis of the secondary endpoints was an ANOVA mode lon the logarithmic scale including 'treatment' ('midazolam' and 'midazolam + Placebo/BI') as fixed effect and 'subject' as random effect. The analysis was performed separately for Day 1 and Day 14.||134.6|102.6|
72404661|NCT03754959|144316669|OTHER||Ratio|94.5|||||TWO_SIDED|90.0|85.5|104.4|||||Ratio is calculated with BI 1358894 50 mg+Midazolam on day 1 in the nominator and the Midazolam on day -1 in the denominator.|The statistical model used for the analysis of the secondary endpoints was an ANOVA mode lon the logarithmic scale including 'treatment' ('midazolam' and 'midazolam + Placebo/BI') as fixed effect and 'subject' as random effect. The analysis was performed separately for Day 1 and Day 14.||104.4|85.5|
72404662|NCT03754959|144316669|OTHER||Ratio|98.2|||||TWO_SIDED|90.0|87.3|99.3|||||Ratio is calculated with BI 1358894 100 mg+Midazolam on day 1 in the nominator and the Midazolam on day -1 in the denominator.|The statistical model used for the analysis of the secondary endpoints was an ANOVA mode lon the logarithmic scale including 'treatment' ('midazolam' and 'midazolam + Placebo/BI') as fixed effect and 'subject' as random effect. The analysis was performed separately for Day 1 and Day 14.||99.3|87.3|
72490541|NCT03259074|144508678|OTHER|Due to to the pre-defined hierarchical testing strategy, p values beyond the primary endpoint which was not met were not presented|Marginal difference|2.18|||||TWO_SIDED|95.0|-5.34|9.69|||Marginal difference||Estimated mean, marginal difference and 95% confidence interval are from a logistic regression model with treatment as a factor using marginal standardization method|||9.69|-5.34|
72516750|NCT02528253|144564388|SUPERIORITY||Odds Ratio (OR)|1.38||||0.0229|TWO_SIDED|95.0|1.05|1.83|||Regression, Logistic|||Week 12, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.83|1.05|0.0229
72490542|NCT03259074|144508679|OTHER||Marginal difference|0.33|||||TWO_SIDED|95.0|-7.08|7.74||Due to to the pre-defined hierarchical testing strategy, p values beyond the primary endpoint which was not met were not presented.|||Estimated mean, marginal difference and 95% confidence interval are from a logistic regression model with treatment as a factor using marginal standardization method|||7.74|-7.08|
72490543|NCT00595556|144508690|SUPERIORITY_OR_OTHER|||||||0.012||95.0|||||Mixed Models Analysis|||||||.012
72490544|NCT00595556|144508691|SUPERIORITY_OR_OTHER|||||||0.94||95.0|||||Mixed Models Analysis|||||||.94
72490545|NCT00595556|144508692|SUPERIORITY_OR_OTHER|||||||0.004||95.0|||||Mixed Models Analysis|||||||.004
72404663|NCT03754959|144316669|OTHER||Ratio|98.0|||||TWO_SIDED|90.0|84.3|114.0|||||Ratio is calculated with BI 1358894 200 mg+Midazolam on day 1 in the nominator and the Midazolam on day -1 in the denominator.|The statistical model used for the analysis of the secondary endpoints was an ANOVA mode lon the logarithmic scale including 'treatment' ('midazolam' and 'midazolam + Placebo/BI') as fixed effect and 'subject' as random effect. The analysis was performed separately for Day 1 and Day 14.||114.0|84.3|
72404664|NCT03754959|144316670|OTHER||Ratio|95.5|||||TWO_SIDED|90.0|81.3|112.1|||||Ratio is calculated with Placebo+Midazolam on day 14 in the nominator and the Midazolam on day -1 in the denominator.|The statistical model used for the analysis of the secondary endpoints was an ANOVA mode lon the logarithmic scale including 'treatment' ('midazolam' and 'midazolam + Placebo/BI') as fixed effect and 'subject' as random effect. The analysis was performed separately for Day 1 and Day 14.||112.1|81.3|
72490546|NCT00595556|144508693|SUPERIORITY_OR_OTHER|||||||0.006||95.0|||||Mixed Models Analysis|||||||.006
72516751|NCT02528253|144564388|SUPERIORITY||Odds Ratio (OR)|1.73||||0.0002|TWO_SIDED|95.0|1.3|2.3|||Regression, Logistic|||Week 12, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||2.30|1.30|0.0002
72490547|NCT00595556|144508694|SUPERIORITY_OR_OTHER|||||||0.3||95.0|||||Mixed Models Analysis|||||||.3
72490548|NCT03029143|144508708|OTHER||Odds Ratio (OR)|0.6|||=|0.401|TWO_SIDED|95.0|0.2|1.8|||Chi-squared||||Chi-squared test was used to estimate P-value from the logistic regression model where Endoscopic Mucosal Healing was the response variable and Treatment and TNF stratification were factors. Baseline complete Mayo Score and natural logarithm of trough concentration at week 6 were covariates.|1.8|0.2|=0.401
72490549|NCT03029143|144508709|OTHER||Adjusted risk difference|-0.4|||=|0.943|TWO_SIDED|95.0|-11.4|10.6|||CMH Chi-square test||||Cochran-Mantel-Haenszel (CMH) chi-square test was stratified by TNF antagonist status.|10.6|-11.4|=0.943
72490550|NCT03029143|144508710|OTHER||Adjusted risk difference|-1.2|||=|0.893|TWO_SIDED|95.0|-18.7|16.3|||CMH Chi-square test||||Cochran-Mantel-Haenszel (CMH) chi-square test was stratified by TNF antagonist status.|16.3|-18.7|=0.893
72490551|NCT03029143|144508711|OTHER||Adjusted risk difference|6.0|||=|0.525|TWO_SIDED|95.0|-12.4|24.3|||CMH Chi-square test||||Cochran-Mantel-Haenszel (CMH) chi-square test was stratified by TNF antagonist status.|24.3|-12.4|=0.525
72490552|NCT03029143|144508712|OTHER||Adjusted risk difference|-6.6|||=|0.623|TWO_SIDED|95.0|-34.0|20.8|||CMH Chi-square test||||Cochran-Mantel-Haenszel (CMH) chi-square test was stratified by TNF antagonist status.|20.8|-34.0|=0.623
72490553|NCT03029143|144508713|SUPERIORITY||Adjusted risk difference|8.1|||=|0.344|TWO_SIDED|95.0|-8.5|24.7|||CMH Chi-square test||||Cochran-Mantel-Haenszel (CMH) chi-square test was stratified by TNF antagonist status.|24.7|-8.5|=0.344
72490554|NCT00619255|144508714|SUPERIORITY||Slope|1.38||||0.71|TWO_SIDED||||||Chi-squared|DF=3||||||0.71
72490555|NCT00619255|144508715|SUPERIORITY||Slope|1.02||||0.8|TWO_SIDED||||||Chi-squared|DF=3||||||0.80
72490556|NCT00619255|144508716|SUPERIORITY|||||||0.67|||||||Chi-squared|"DF = 1~Chi-Square Value = 0.18"||||||0.67
72490557|NCT00619255|144508717|SUPERIORITY||Slope|9.0||||0.03|TWO_SIDED||||||Chi-squared|DF=3||||||0.03
72490558|NCT00619255|144508718|SUPERIORITY||Slope|1.35||||0.72|TWO_SIDED||||||Chi-squared|DF=3||||||0.72
72490559|NCT02121262|144508732|SUPERIORITY||Rate Difference|1.5||||0.7431|TWO_SIDED|95.0|-5.9|8.9|||Cochran-Mantel-Haenszel|Based on the Cochran-Mantel-Haenszel (CMH) general association test stratified by baseline BCVA categories.||||8.9|-5.9|0.7431
72490560|NCT02121262|144508733|SUPERIORITY||Least Squares Mean (LSM) Difference|2.9|STANDARD_ERROR_OF_MEAN|0.89||0.0011|TWO_SIDED|95.0|1.17|4.66|||ANCOVA|The ANCOVA model included the treatment group as the main effect and baseline BCVA score as the covariate.|Null hypothesis-there was no difference in treatment groups of average BCVA CFB in 12-months. Hypothesis test-based on 2-sided test at 0.05 significance level,confidence interval(CI) was constructed between treatment groups in LSM using ANCOVA model.|||4.66|1.17|0.0011
72490561|NCT02121262|144508734|SUPERIORITY||Least Squares Mean Difference|-89.3|STANDARD_ERROR_OF_MEAN|16.89|<|0.0001|TWO_SIDED|95.0|-122.53|-56.01|||ANCOVA|Based on ANCOVA model with treatment and baseline BCVA categories as main effects and baseline retinal thickness as the covariate.|Null hypothesis was there was no difference in treatment groups in average BCVA CFB in 12-months. Hypothesis test was based on 2-sided test at 0.05 significance level. 2-sided 95% CI was constructed between treatment groups in LSM using ANCOVA model.|||-56.01|-122.53|<0.0001
72490562|NCT02121262|144508735|SUPERIORITY||Least Squares Mean Difference|-7.729|STANDARD_ERROR_OF_MEAN|1.0443|<|0.0001|TWO_SIDED|95.0|-9.7855|-5.6733|||ANCOVA|Based on ANCOVA model with treatment and baseline BCVA categories as main effects and baseline total leakage area as the covariate.|Null hypothesis was there was no difference in treatment groups in average BCVA CFB in 12-months. Hypothesis test was based on 2-sided test at 0.05 significance level. 2-sided 95% CI was constructed between treatment groups in LSM using ANCOVA model.|||-5.6733|-9.7855|<0.0001
72490563|NCT01765920|144508754|SUPERIORITY|||||||0.0174||||||A priori threshold for statistical significance α=0.0221 (Pocock boundary for 3 interim analyses).|Kruskal-Wallis|||||||0.0174
72490564|NCT01765920|144508755|SUPERIORITY|||||||0.0719||||||A priori threshold for statistical significance α=0.0221 (Pocock boundary for 3 interim analyses).|Kruskal-Wallis|||||||0.0719
72490565|NCT01765920|144508756|SUPERIORITY|||||||0.02||||||Total score analysis. A priori threshold for statistical significance α=0.0221 (Pocock boundary for 3 interim analyses).|Kruskal-Wallis|||||||0.02
72490566|NCT01765920|144508756|SUPERIORITY|||||||0.0099||||||"Symptoms domain analysis. A priori threshold for statistical significance α=0.0221 (Pocock boundary for 3 interim analyses)."|Kruskal-Wallis|||||||0.0099
72490567|NCT01765920|144508756|SUPERIORITY|||||||0.037||||||"Ability domain analysis. A priori threshold for statistical significance α=0.0221 (Pocock boundary for 3 interim analyses)."|Kruskal-Wallis|||||||0.037
72490568|NCT01765920|144508757|SUPERIORITY|||||||0.22||||||Day 1 analysis.|Fisher Exact|||||||0.22
72490569|NCT01765920|144508757|SUPERIORITY|||||||0.32||||||Day 2 analysis.|Fisher Exact|||||||0.32
72490570|NCT01765920|144508757|SUPERIORITY|||||||0.47||||||Day 3 analysis.|Fisher Exact|||||||0.47
72490571|NCT01765920|144508757|SUPERIORITY|||||||0.72||||||Day 4 analysis.|Fisher Exact|||||||0.72
72516752|NCT02528253|144564388|SUPERIORITY||Odds Ratio (OR)|1.14||||0.315|TWO_SIDED|95.0|0.88|1.47|||Regression, Logistic|||Week 12, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.47|0.88|0.3150
72516753|NCT02528253|144564388|SUPERIORITY||Odds Ratio (OR)|1.21||||0.137|TWO_SIDED|95.0|0.94|1.57|||Regression, Logistic|||Week 12, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.57|0.94|0.1370
72516754|NCT02528253|144564388|SUPERIORITY||Odds Ratio (OR)|1.52||||0.0018|TWO_SIDED|95.0|1.17|1.97|||Regression, Logistic|||Week 12, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.97|1.17|0.0018
72516755|NCT02528253|144564388|SUPERIORITY||Odds Ratio (OR)|1.36||||0.0342|TWO_SIDED|95.0|1.02|1.81|||Regression, Logistic|||Week 12, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.81|1.02|0.0342
72516756|NCT02528253|144564388|SUPERIORITY||Odds Ratio (OR)|1.69||||0.0003|TWO_SIDED|95.0|1.27|2.24|||Regression, Logistic|||Week 12, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||2.24|1.27|0.0003
72516757|NCT02528253|144564388|SUPERIORITY||Odds Ratio (OR)|1.16||||0.2561|TWO_SIDED|95.0|0.9|1.51|||Regression, Logistic|||Week 12, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.51|0.90|0.2561
72516758|NCT02528253|144564388|SUPERIORITY||Odds Ratio (OR)|1.17||||0.2358|TWO_SIDED|95.0|0.9|1.51|||Regression, Logistic|||Week 12, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.51|0.90|0.2358
72516759|NCT02528253|144564388|SUPERIORITY||Odds Ratio (OR)|1.45||||0.004|TWO_SIDED|95.0|1.13|1.87|||Regression, Logistic|||Week 12, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.87|1.13|0.0040
72516760|NCT02528253|144564388|SUPERIORITY||Odds Ratio (OR)|1.4||||0.0723|TWO_SIDED|95.0|0.97|2.02|||Regression, Logistic|||Week 12, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||2.02|0.97|0.0723
72490572|NCT01765920|144508757|SUPERIORITY|||||||0.25||||||Day 5 analysis.|Fisher Exact|||||||0.25
72490573|NCT01765920|144508758|SUPERIORITY|||||||0.68|||||||Fisher Exact|||||||0.68
72490574|NCT01923129|144508787|NON_INFERIORITY|The primary outcome of interest was the rate of AUR, defined as the number of patients with AUR within each study group. A 15% non-inferiority margin was chosen according to clinical relevance estimation. The expected difference between the two groups was 0%. Non-inferiority analysis was performed by calculation of risk difference and its 95% confidence interval according to Newcombe \& Altman.|||||<|0.05|TWO_SIDED|95.0|||||Chi-squared|||||||<0.05
72490575|NCT03631732|144508791|NON_INFERIORITY|B/F/TAF is non-inferior to SBR if the upper bound of the 2-sided 95% confidence interval (CI) of the difference between treatment groups \[B/F/TAF - SBR\] in the percentage of participants with HIV-1 RNA ≥ 50 copies/mL is less than 6% (i.e., a margin of 6% is applied to non-inferiority assessment).|Difference in percentages|-1.2|||||TWO_SIDED|95.0|-4.8|0.9|||||Differences in percentages of participants with HIV-1 RNA \>= 50 copies/mL between treatment groups and 95% CI were calculated based on exact method.|||0.9|-4.8|
72490576|NCT03631732|144508791|SUPERIORITY|||||||0.3399|||||||Fisher Exact|||||||0.3399
72516761|NCT02528253|144564388|SUPERIORITY||Odds Ratio (OR)|2.06|||<|0.0001|TWO_SIDED|95.0|1.45|2.92|||Regression, Logistic|||Week 12, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||2.92|1.45|<.0001
72516762|NCT02528253|144564388|SUPERIORITY||Odds Ratio (OR)|1.38||||0.0653|TWO_SIDED|95.0|0.98|1.94|||Regression, Logistic|||Week 12, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.94|0.98|0.0653
72516763|NCT02528253|144564388|SUPERIORITY||Odds Ratio (OR)|1.02||||0.9177|TWO_SIDED|95.0|0.74|1.4|||Regression, Logistic|||Week 12, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.40|0.74|0.9177
72516764|NCT02528253|144564388|SUPERIORITY||Odds Ratio (OR)|1.49||||0.0088|TWO_SIDED|95.0|1.11|2.01|||Regression, Logistic|||Week 12, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||2.01|1.11|0.0088
72568720|NCT01144364|144668589|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.65||||0.084|TWO_SIDED|95.0|0.39|1.06||Univariate analysis|Fine and Gray model|Fine and Gray model stratified for the stratification groups.||||1.06|0.39|0.084
72568721|NCT01144364|144668589|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.62||||0.052|TWO_SIDED|95.0|0.38|1.0|||Fine and Gray model|Fine and Gray model adjusted for stratification group, age, sex, Eastern Cooperative Oncology Group Performance Status, and FLIPI score||||1.00|0.38|0.052
72568722|NCT01635062|144668590|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|1.3||||0.69|TWO_SIDED||||||ANOVA|||The hypothesis was that calcitriol therapy would lower plasma renin activity (PRA), when sodium restricted, when compared to placebo.||||0.69
72568723|NCT01635062|144668591|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|15.8||||0.89|TWO_SIDED||||||ANOVA|||The hypothesis was that calcitriol therapy would raise renal plasma flow, when sodium loaded, when compared to placebo.||||0.89
72624518|NCT02947048|144778694|SUPERIORITY||Mean Difference (Final Values)|0.25|STANDARD_ERROR_OF_MEAN|0.47||0.61|TWO_SIDED||||||ANCOVA|||Clinical Global Impression - Improvement||||0.61
72624519|NCT02947048|144778694|SUPERIORITY||Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.43||0.91|TWO_SIDED||||||ANCOVA|||Clinical Global Impression - Improvement||||0.91
72404665|NCT03754959|144316670|OTHER||Ratio|105.7|||||TWO_SIDED|90.0|91.5|122.0|||||Ratio is calculated with BI 1358894 10mg +Midazolam on day 14 in the nominator and the Midazolam on day -1 in the denominator.|The statistical model used for the analysis of the secondary endpoints was an ANOVA mode lon the logarithmic scale including 'treatment' ('midazolam' and 'midazolam + Placebo/BI') as fixed effect and 'subject' as random effect. The analysis was performed separately for Day 1 and Day 14.||122.0|91.5|
72624520|NCT03331354|144778703|SUPERIORITY||Cox Proportional Hazard|1.87|||=|0.016|TWO_SIDED||||||Chi-squared|||||||=.016
72624521|NCT03331354|144778704|SUPERIORITY|||||||0.008|||||||ANCOVA|Initial interview scores were used as control in the ANCOVA||||||.008
72624522|NCT03331354|144778705|SUPERIORITY|||||||0.99|||||||ANCOVA|Change in confidence was evaluated using time one as a covariate.||||||.99
72404666|NCT03754959|144316670|OTHER||Ratio|116.3|||||TWO_SIDED|90.0|90.9|148.7|||||Ratio is calculated with BI 1358894 25 mg+Midazolam on day 14 in the nominator and the Midazolam on day -1 in the denominator.|The statistical model used for the analysis of the secondary endpoints was an ANOVA mode lon the logarithmic scale including 'treatment' ('midazolam' and 'midazolam + Placebo/BI') as fixed effect and 'subject' as random effect. The analysis was performed separately for Day 1 and Day 14.||148.7|90.9|
72516765|NCT02528253|144564388|SUPERIORITY||Odds Ratio (OR)|1.58||||0.1197|TWO_SIDED|95.0|0.89|2.83|||Regression, Logistic|||Week 12, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||2.83|0.89|0.1197
72516766|NCT02528253|144564388|SUPERIORITY||Odds Ratio (OR)|1.64||||0.0913|TWO_SIDED|95.0|0.92|2.92|||Regression, Logistic|||Week 12, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||2.92|0.92|0.0913
72516767|NCT02528253|144564388|SUPERIORITY||Odds Ratio (OR)|1.25||||0.4317|TWO_SIDED|95.0|0.72|2.19|||Regression, Logistic|||Week 12, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||2.19|0.72|0.4317
72516768|NCT02528253|144564388|SUPERIORITY||Odds Ratio (OR)|1.27||||0.3498|TWO_SIDED|95.0|0.77|2.08|||Regression, Logistic|||Week 12, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||2.08|0.77|0.3498
72516769|NCT02528253|144564388|SUPERIORITY||Odds Ratio (OR)|1.31||||0.2768|TWO_SIDED|95.0|0.8|2.15|||Regression, Logistic|||Week 12, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||2.15|0.80|0.2768
72516770|NCT02528253|144564388|SUPERIORITY||Odds Ratio (OR)|1.45||||0.0101|TWO_SIDED|95.0|1.09|1.92|||Regression, Logistic|||Week 16, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.92|1.09|0.0101
72516771|NCT02528253|144564388|SUPERIORITY||Odds Ratio (OR)|1.5||||0.0054|TWO_SIDED|95.0|1.13|1.99|||Regression, Logistic|||Week 16, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.99|1.13|0.0054
72516772|NCT02528253|144564388|SUPERIORITY||Odds Ratio (OR)|1.08||||0.5493|TWO_SIDED|95.0|0.84|1.39|||Regression, Logistic|||Week 16, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.39|0.84|0.5493
72516773|NCT02528253|144564388|SUPERIORITY||Odds Ratio (OR)|1.34||||0.0269|TWO_SIDED|95.0|1.03|1.74|||Regression, Logistic|||Week 16, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.74|1.03|0.0269
72516774|NCT02528253|144564388|SUPERIORITY||Odds Ratio (OR)|1.38||||0.0144|TWO_SIDED|95.0|1.07|1.8|||Regression, Logistic|||Week 16, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.80|1.07|0.0144
72516775|NCT02528253|144564388|SUPERIORITY||Odds Ratio (OR)|1.28||||0.0846|TWO_SIDED|95.0|0.97|1.7|||Regression, Logistic|||Week 16, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.70|0.97|0.0846
72516776|NCT02528253|144564388|SUPERIORITY||Odds Ratio (OR)|1.45||||0.0101|TWO_SIDED|95.0|1.09|1.91|||Regression, Logistic|||Week 16, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.91|1.09|0.0101
72516777|NCT02528253|144564388|SUPERIORITY||Odds Ratio (OR)|1.25||||0.0848|TWO_SIDED|95.0|0.97|1.62|||Regression, Logistic|||Week 16, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.62|0.97|0.0848
72516778|NCT02528253|144564388|SUPERIORITY||Odds Ratio (OR)|1.02||||0.8732|TWO_SIDED|95.0|0.79|1.32|||Regression, Logistic|||Week 16, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.32|0.79|0.8732
72516779|NCT02528253|144564388|SUPERIORITY||Odds Ratio (OR)|1.15||||0.2734|TWO_SIDED|95.0|0.89|1.48|||Regression, Logistic|||Week 16, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.48|0.89|0.2734
72516780|NCT02528253|144564388|SUPERIORITY||Odds Ratio (OR)|1.21||||0.2839|TWO_SIDED|95.0|0.86|1.7|||Regression, Logistic|||Week 16, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.70|0.86|0.2839
72516781|NCT02528253|144564388|SUPERIORITY||Odds Ratio (OR)|1.47||||0.0238|TWO_SIDED|95.0|1.05|2.07|||Regression, Logistic|||Week 16, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||2.07|1.05|0.0238
72516782|NCT02528253|144564388|SUPERIORITY||Odds Ratio (OR)|1.11||||0.5212|TWO_SIDED|95.0|0.81|1.53|||Regression, Logistic|||Week 16, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.53|0.81|0.5212
72624523|NCT03331354|144778705|SUPERIORITY|||||||0.99|||||||ANCOVA|Interview scores at enrollment were used as a covariate||||||.99
72624524|NCT03331354|144778706|OTHER||||||<|0.001|||||||Pearson Correlation|||This post-hoc analysis was performed on only the COMPASS group to determine the association between percent of the online system completed and change in interview scores||||<.001
72624525|NCT01506726|144778748|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.94||||0.23|TWO_SIDED|95.0|-2.08|0.2|||Wilcoxon (Mann-Whitney)|Wilcoxon two sample test||||0.20|-2.08|0.230
72624526|NCT01506726|144778749|SUPERIORITY_OR_OTHER|||||||0.347|TWO_SIDED||||||t-test, 2 sided|||||||0.347
72624527|NCT01506726|144778750|SUPERIORITY_OR_OTHER|||||||0.857|TWO_SIDED|||||Correlation between change in IL-6 and change in hemoglobin in the salsalate group. Testing the correlation equal to 0.|t-test, 2 sided|||||||0.857
72624528|NCT01506726|144778750|SUPERIORITY_OR_OTHER|||||||0.706|TWO_SIDED|||||Correlation between change in IL-6 and change in hemoglobin in the placebo group. Testing the correlation equal to 0.|t-test, 2 sided|||||||0.706
72624529|NCT01506726|144778750|SUPERIORITY_OR_OTHER|||||||0.014|TWO_SIDED|||||Correlation between change in TNF and change in hemoglobin in the salsalate group. Testing the correlation equal to 0.|t-test, 2 sided|||||||0.014
72404667|NCT03754959|144316670|OTHER||Ratio|106.8|||||TWO_SIDED|90.0|92.4|123.4|||||Ratio is calculated with BI 1358894 50 mg+Midazolam on day 14 in the nominator and the Midazolam on day -1 in the denominator.|The statistical model used for the analysis of the secondary endpoints was an ANOVA mode lon the logarithmic scale including 'treatment' ('midazolam' and 'midazolam + Placebo/BI') as fixed effect and 'subject' as random effect. The analysis was performed separately for Day 1 and Day 14.||123.4|92.4|
72624530|NCT01506726|144778750|SUPERIORITY_OR_OTHER|||||||0.136|TWO_SIDED|||||Correlation between change in TNF and change in hemoglobin in the placebo group. Testing the correlation equal to 0.|t-test, 2 sided|||||||0.136
72624531|NCT01506726|144778750|SUPERIORITY_OR_OTHER|||||||0.803|TWO_SIDED|||||Correlation between change in CRP and change in hemoglobin in the salsalate group. Testing the correlation equal to 0.|t-test, 2 sided|||||||0.803
72516783|NCT02528253|144564388|SUPERIORITY||Odds Ratio (OR)|1.09||||0.5954|TWO_SIDED|95.0|0.8|1.48|||Regression, Logistic|||Week 16, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.48|0.80|0.5954
72516784|NCT02528253|144564388|SUPERIORITY||Odds Ratio (OR)|1.33||||0.0638|TWO_SIDED|95.0|0.98|1.79|||Regression, Logistic|||Week 16, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.79|0.98|0.0638
72516785|NCT02528253|144564388|SUPERIORITY||Odds Ratio (OR)|1.38||||0.2661|TWO_SIDED|95.0|0.78|2.44|||Regression, Logistic|||Week 16, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||2.44|0.78|0.2661
72516786|NCT02528253|144564388|SUPERIORITY||Odds Ratio (OR)|1.24||||0.4717|TWO_SIDED|95.0|0.69|2.21|||Regression, Logistic|||Week 16, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||2.21|0.69|0.4717
72516787|NCT02528253|144564388|SUPERIORITY||Odds Ratio (OR)|1.17||||0.5798|TWO_SIDED|95.0|0.68|2.0|||Regression, Logistic|||Week 16, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||2.00|0.68|0.5798
72516788|NCT02528253|144564388|SUPERIORITY||Odds Ratio (OR)|1.18||||0.5027|TWO_SIDED|95.0|0.72|1.95|||Regression, Logistic|||Week 16, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.95|0.72|0.5027
72516789|NCT02528253|144564388|SUPERIORITY||Odds Ratio (OR)|1.06||||0.8165|TWO_SIDED|95.0|0.64|1.77|||Regression, Logistic|||Week 16, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.77|0.64|0.8165
72516790|NCT02528253|144564388|SUPERIORITY||Odds Ratio (OR)|1.18||||0.1996|TWO_SIDED|95.0|0.92|1.52|||Regression, Logistic|||Week 24, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.52|0.92|0.1996
72516791|NCT02528253|144564388|SUPERIORITY||Odds Ratio (OR)|1.42||||0.0074|TWO_SIDED|95.0|1.1|1.83|||Regression, Logistic|||Week 24, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.83|1.10|0.0074
72516792|NCT02528253|144564388|SUPERIORITY||Odds Ratio (OR)|1.13||||0.3557|TWO_SIDED|95.0|0.87|1.45|||Regression, Logistic|||Week 24, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.45|0.87|0.3557
72516793|NCT02528253|144564388|SUPERIORITY||Odds Ratio (OR)|1.36||||0.017|TWO_SIDED|95.0|1.06|1.75|||Regression, Logistic|||Week 24, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.75|1.06|0.0170
72516794|NCT02528253|144564388|SUPERIORITY||Odds Ratio (OR)|1.03||||0.8641|TWO_SIDED|95.0|0.76|1.38|||Regression, Logistic|||Week 24, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.38|0.76|0.8641
72516795|NCT02528253|144564388|SUPERIORITY||Odds Ratio (OR)|1.22||||0.1768|TWO_SIDED|95.0|0.91|1.62|||Regression, Logistic|||Week 24, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.62|0.91|0.1768
72516796|NCT02528253|144564388|SUPERIORITY||Odds Ratio (OR)|0.93||||0.7696|TWO_SIDED|95.0|0.55|1.55|||Regression, Logistic|||Week 24, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.55|0.55|0.7696
72404668|NCT03754959|144316670|OTHER||Ratio|83.9|||||TWO_SIDED|90.0|71.2|98.9|||||Ratio is calculated with BI 1358894 100 mg+Midazolam on day 14 in the nominator and the Midazolam on day -1 in the denominator.|The statistical model used for the analysis of the secondary endpoints was an ANOVA mode lon the logarithmic scale including 'treatment' ('midazolam' and 'midazolam + Placebo/BI') as fixed effect and 'subject' as random effect. The analysis was performed separately for Day 1 and Day 14.||98.9|71.2|
72490577|NCT03631732|144508793|NON_INFERIORITY|B/F/TAF is non-inferior to SBR if the lower bound of the 2-sided 95% CI of the difference between treatment groups \[B/F/TAF - SBR\] in the percentage of participants with HIV-1 RNA \< 50 copies/mL is greater than -10% (i.e., a margin of 10% is applied to non-inferiority assessment).|Difference in percentages|1.8|||||TWO_SIDED|95.0|-2.0|6.8|||||Differences in percentages of participants with HIV-1 RNA \< 50 copies/mL between treatment groups and 95% CI were calculated based on exact method.|||6.8|-2.0|
72516797|NCT02528253|144564388|SUPERIORITY||Odds Ratio (OR)|1.09||||0.7433|TWO_SIDED|95.0|0.66|1.78|||Regression, Logistic|||Week 24, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.78|0.66|0.7433
72490578|NCT03631732|144508793|SUPERIORITY|||||||0.3532|||||||Fisher Exact|||||||0.3532
72490579|NCT03631732|144508794|NON_INFERIORITY|B/F/TAF is non-inferior to SBR if the lower bound of the 2-sided 95% CI of the difference between treatment groups \[B/F/TAF - SBR\] in the percentage of participants with HIV-1 RNA \< 50 copies/mL is greater than -10% (i.e., a margin of 10% is applied to non-inferiority assessment).|Difference in percentages|1.4|||||TWO_SIDED|95.0|-1.0|5.3|||||Differences in percentages of participants with HIV-1 RNA \< 50 copies/mL between treatment groups and 95% CI were calculated based on exact method.|||5.3|-1.0|
72490580|NCT03631732|144508794|SUPERIORITY|||||||0.3356|||||||Fisher Exact|||||||0.3356
72490581|NCT03631732|144508796|OTHER||Difference in LSM|11.0||||0.5618|TWO_SIDED|95.0|-27.0|49.0|||ANOVA|P-value was calculated from ANOVA model with treatment as a fixed effect.|Difference in LSM (Least square mean) and its 95% C.I. was calculated from ANOVA model with treatment as a fixed effect.|||49|-27|0.5618
72490582|NCT03631732|144508797|OTHER||Difference in LSM|9.0||||0.6632|TWO_SIDED|95.0|-31.0|48.0|||ANOVA|P-value was calculated from ANOVA model with treatment as a fixed effect.|Difference in LSM and its 95% C.I. was calculated from ANOVA model with treatment as a fixed effect.|||48|-31|0.6632
72490583|NCT00768521|144508816|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|23.18||||0.008||90.0|7.58|41.06||1-sided, alpha = 0.05|ANCOVA|Baseline used as covariate.|Primary Hypothesis: Tolterodine LA 4 mg is superior to placebo with respect to change from baseline in maximum cystometric capacity at 4 hours post Dose 7 (i.e., steady state). The expected treatment effect is targeted at 40 mL.|||41.06|7.58|0.008
72490584|NCT00768521|144508817|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.63||||0.422||90.0|-11.5|16.71||1-sided, alpha = 0.05|ANCOVA|Baseline used as covariate.||||16.71|-11.5|0.422
72490585|NCT02873936|144508824|SUPERIORITY||Difference in Response Rates|34.9|||<|0.001|TWO_SIDED|95.0|23.5|46.3||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg vs Placebo at Week 12||46.3|23.5|<0.001
72490586|NCT02873936|144508824|SUPERIORITY||Difference in Response Rates|26.4|||<|0.001|TWO_SIDED|95.0|15.0|37.9||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg vs Placebo at Week 12||37.9|15.0|<0.001
72516798|NCT02528253|144564388|SUPERIORITY||Odds Ratio (OR)|1.28||||0.0562|TWO_SIDED|95.0|0.99|1.65|||Regression, Logistic|||Week 32, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.65|0.99|0.0562
72516799|NCT02528253|144564388|SUPERIORITY||Odds Ratio (OR)|1.33||||0.0274|TWO_SIDED|95.0|1.03|1.71|||Regression, Logistic|||Week 32, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.71|1.03|0.0274
72516800|NCT02528253|144564388|SUPERIORITY||Odds Ratio (OR)|1.22||||0.1206|TWO_SIDED|95.0|0.95|1.58|||Regression, Logistic|||Week 32, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.58|0.95|0.1206
72516801|NCT02528253|144564388|SUPERIORITY||Odds Ratio (OR)|1.31||||0.0365|TWO_SIDED|95.0|1.02|1.69|||Regression, Logistic|||Week 32, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.69|1.02|0.0365
72516802|NCT02528253|144564388|SUPERIORITY||Odds Ratio (OR)|1.28||||0.0964|TWO_SIDED|95.0|0.96|1.71|||Regression, Logistic|||Week 32, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.71|0.96|0.0964
72516803|NCT02528253|144564388|SUPERIORITY||Odds Ratio (OR)|1.19||||0.2515|TWO_SIDED|95.0|0.89|1.59|||Regression, Logistic|||Week 32, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.59|0.89|0.2515
72516804|NCT02528253|144564388|SUPERIORITY||Odds Ratio (OR)|1.06||||0.8122|TWO_SIDED|95.0|0.66|1.71|||Regression, Logistic|||Week 32, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.71|0.66|0.8122
72516805|NCT02528253|144564388|SUPERIORITY||Odds Ratio (OR)|1.36||||0.1848|TWO_SIDED|95.0|0.86|2.13|||Regression, Logistic|||Week 32, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||2.13|0.86|0.1848
72516806|NCT02528253|144564388|SUPERIORITY||Odds Ratio (OR)|1.16||||0.2622|TWO_SIDED|95.0|0.9|1.49|||Regression, Logistic|||Week 40, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.49|0.90|0.2622
72516807|NCT02528253|144564388|SUPERIORITY||Odds Ratio (OR)|1.2||||0.1579|TWO_SIDED|95.0|0.93|1.54|||Regression, Logistic|||Week 40, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.54|0.93|0.1579
72516808|NCT02528253|144564388|SUPERIORITY||Odds Ratio (OR)|1.15||||0.2773|TWO_SIDED|95.0|0.89|1.49|||Regression, Logistic|||Week 40, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.49|0.89|0.2773
72516809|NCT02528253|144564388|SUPERIORITY||Odds Ratio (OR)|1.24||||0.1032|TWO_SIDED|95.0|0.96|1.59|||Regression, Logistic|||Week 40, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.59|0.96|0.1032
72516810|NCT02528253|144564388|SUPERIORITY||Odds Ratio (OR)|1.12||||0.4418|TWO_SIDED|95.0|0.84|1.5|||Regression, Logistic|||Week 40, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.50|0.84|0.4418
72516811|NCT02528253|144564388|SUPERIORITY||Odds Ratio (OR)|1.23||||0.1608|TWO_SIDED|95.0|0.92|1.63|||Regression, Logistic|||Week 40, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.63|0.92|0.1608
72516812|NCT02528253|144564388|SUPERIORITY||Odds Ratio (OR)|1.29||||0.2628|TWO_SIDED|95.0|0.83|2.02|||Regression, Logistic|||Week 40, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||2.02|0.83|0.2628
72516813|NCT02528253|144564388|SUPERIORITY||Odds Ratio (OR)|1.55||||0.0447|TWO_SIDED|95.0|1.01|2.39|||Regression, Logistic|||Week 40, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||2.39|1.01|0.0447
72516814|NCT02528253|144564388|SUPERIORITY||Odds Ratio (OR)|1.16||||0.256|TWO_SIDED|95.0|0.9|1.49|||Regression, Logistic|||Week 48, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.49|0.90|0.2560
72516815|NCT02528253|144564388|SUPERIORITY||Odds Ratio (OR)|1.19||||0.1741|TWO_SIDED|95.0|0.93|1.53|||Regression, Logistic|||Week 48, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.53|0.93|0.1741
72516816|NCT02528253|144564388|SUPERIORITY||Odds Ratio (OR)|1.2||||0.1647|TWO_SIDED|95.0|0.93|1.55|||Regression, Logistic|||Week 48, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.55|0.93|0.1647
72516817|NCT02528253|144564388|SUPERIORITY||Odds Ratio (OR)|1.28||||0.0619|TWO_SIDED|95.0|0.99|1.65|||Regression, Logistic|||Week 48, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.65|0.99|0.0619
72516818|NCT02528253|144564388|SUPERIORITY||Odds Ratio (OR)|1.21||||0.2025|TWO_SIDED|95.0|0.9|1.61|||Regression, Logistic|||Week 48, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.61|0.90|0.2025
72516819|NCT02528253|144564388|SUPERIORITY||Odds Ratio (OR)|1.18||||0.2601|TWO_SIDED|95.0|0.88|1.58|||Regression, Logistic|||Week 48, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.58|0.88|0.2601
72516820|NCT02528253|144564388|SUPERIORITY||Odds Ratio (OR)|1.14||||0.5635|TWO_SIDED|95.0|0.73|1.77|||Regression, Logistic|||Week 48, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.77|0.73|0.5635
72516821|NCT02528253|144564388|SUPERIORITY||Odds Ratio (OR)|1.38||||0.1338|TWO_SIDED|95.0|0.91|2.11|||Regression, Logistic|||Week 48, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||2.11|0.91|0.1338
72516822|NCT02528253|144564388|SUPERIORITY||Odds Ratio (OR)|1.17||||0.2137|TWO_SIDED|95.0|0.91|1.51|||Regression, Logistic|||Week 56, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.51|0.91|0.2137
72404669|NCT03754959|144316670|OTHER||Ratio|87.2|||||TWO_SIDED|90.0|73.5|103.5|||||Ratio is calculated with BI 1358894 200 mg+Midazolam on day 14 in the nominator and the Midazolam on day -1 in the denominator.|The statistical model used for the analysis of the secondary endpoints was an ANOVA mode lon the logarithmic scale including 'treatment' ('midazolam' and 'midazolam + Placebo/BI') as fixed effect and 'subject' as random effect. The analysis was performed separately for Day 1 and Day 14.||103.5|73.5|
72404670|NCT00449956|144316676|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.68||||||95.0|-1.3|-0.06|||||An analysis of covariance model with a factor for treatment and time-matched baseline as a covariate was used to compute 95% confidence intervals.|||-0.06|-1.30|
72404671|NCT00449956|144316676|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin = 1.2 mmHg|Mean Difference (Final Values)|0.28||||||95.0|-0.22|0.78|||||An analysis of covariance model with a factor for treatment and time-matched baseline as a covariate was used to compute 95% confidence intervals.|||0.78|-0.22|
72404672|NCT01988571|144316690|SUPERIORITY|Power described in protocol.|Mean Difference (Net)|0.1608|STANDARD_ERROR_OF_MEAN|0.7787||0.84|TWO_SIDED||||||ANCOVA|Adjusted for multiple imputation of missing data||Linear models adjusting for baseline values and utilized multiple imputation for missing data.||||0.84
72516823|NCT02528253|144564388|SUPERIORITY||Odds Ratio (OR)|1.33||||0.0256|TWO_SIDED|95.0|1.04|1.72|||Regression, Logistic|||Week 56, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.72|1.04|0.0256
72516824|NCT02528253|144564388|SUPERIORITY||Odds Ratio (OR)|1.13||||0.3531|TWO_SIDED|95.0|0.87|1.46|||Regression, Logistic|||Week 56, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.46|0.87|0.3531
72516825|NCT02528253|144564388|SUPERIORITY||Odds Ratio (OR)|1.31||||0.0358|TWO_SIDED|95.0|1.02|1.7|||Regression, Logistic|||Week 56, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.70|1.02|0.0358
72516826|NCT02528253|144564388|SUPERIORITY||Odds Ratio (OR)|1.22||||0.184|TWO_SIDED|95.0|0.91|1.62|||Regression, Logistic|||Week 56, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.62|0.91|0.1840
72516827|NCT02528253|144564388|SUPERIORITY||Odds Ratio (OR)|1.25||||0.125|TWO_SIDED|95.0|0.94|1.67|||Regression, Logistic|||Week 56, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.67|0.94|0.1250
72516828|NCT02528253|144564388|SUPERIORITY||Odds Ratio (OR)|0.95||||0.8266|TWO_SIDED|95.0|0.61|1.48|||Regression, Logistic|||Week 56, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.48|0.61|0.8266
72516829|NCT02528253|144564388|SUPERIORITY||Odds Ratio (OR)|1.13||||0.5673|TWO_SIDED|95.0|0.74|1.72|||Regression, Logistic|||Week 56, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.72|0.74|0.5673
72516830|NCT02528253|144564389|SUPERIORITY||Odds Ratio (OR)|1.53||||0.0076|TWO_SIDED|95.0|1.12|2.08|||Regression, Logistic|||Week 2, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||2.08|1.12|0.0076
72516831|NCT02528253|144564389|SUPERIORITY||Odds Ratio (OR)|1.98|||<|0.0001|TWO_SIDED|95.0|1.46|2.69|||Regression, Logistic|||Week 2, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||2.69|1.46|<.0001
72516832|NCT02528253|144564389|SUPERIORITY||Odds Ratio (OR)|1.31||||0.07|TWO_SIDED|95.0|0.98|1.74|||Regression, Logistic|||Week 2, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.74|0.98|0.0700
72516833|NCT02528253|144564389|SUPERIORITY||Odds Ratio (OR)|1.17||||0.2655|TWO_SIDED|95.0|0.89|1.54|||Regression, Logistic|||Week 2, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.54|0.89|0.2655
72516834|NCT02528253|144564389|SUPERIORITY||Odds Ratio (OR)|1.52||||0.0022|TWO_SIDED|95.0|1.16|1.98|||Regression, Logistic|||Week 2, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.98|1.16|0.0022
72516835|NCT02528253|144564389|SUPERIORITY||Odds Ratio (OR)|1.61||||0.0125|TWO_SIDED|95.0|1.11|2.35|||Regression, Logistic|||Week 2, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||2.35|1.11|0.0125
72516836|NCT02528253|144564389|SUPERIORITY||Odds Ratio (OR)|1.75||||0.0032|TWO_SIDED|95.0|1.21|2.54|||Regression, Logistic|||Week 2, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||2.54|1.21|0.0032
72516837|NCT02528253|144564389|SUPERIORITY||Odds Ratio (OR)|1.3||||0.1528|TWO_SIDED|95.0|0.91|1.85|||Regression, Logistic|||Week 2, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.85|0.91|0.1528
72516838|NCT02528253|144564389|SUPERIORITY||Odds Ratio (OR)|1.24||||0.1863|TWO_SIDED|95.0|0.9|1.72|||Regression, Logistic|||Week 2, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.72|0.90|0.1863
72516839|NCT02528253|144564389|SUPERIORITY||Odds Ratio (OR)|1.35||||0.0667|TWO_SIDED|95.0|0.98|1.86|||Regression, Logistic|||Week 2, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.86|0.98|0.0667
72568724|NCT01635062|144668592|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.0||||0.8|TWO_SIDED||||||ANOVA|||The hypothesis was that calcitriol therapy would lower urine protein, when sodium loaded, when compared to placebo.||||0.80
72624532|NCT01506726|144778750|SUPERIORITY_OR_OTHER|||||||0.894|TWO_SIDED|||||Correlation between change in CRP and change in hemoglobin in the placebo group. Testing the correlation equal to 0.|t-test, 2 sided|||||||0.894
72624533|NCT01506726|144778751|SUPERIORITY_OR_OTHER|||||||0.143|TWO_SIDED|||||P value comparing change in IL6 between treatment groups.|t-test, 2 sided|||||||0.143
72624534|NCT01506726|144778751|SUPERIORITY_OR_OTHER|||||||0.257|TWO_SIDED|||||P value comparing the change in TNF between treatment groups.|t-test, 2 sided|||||||0.257
72624535|NCT01506726|144778752|SUPERIORITY_OR_OTHER|||||||0.535|TWO_SIDED|||||P-value comparing the change in EPO between treatment groups.|t-test, 2 sided|||||||0.535
72568725|NCT01301508|144668597|SUPERIORITY_OR_OTHER|||||||0.008||||||p-value was calculated for the statistical significant difference between greater decrease in vehicle lesion and greater decrease in active lesion for the AN2898 Topical Ointment, 1% + Ointment Vehicle group.|Two-sided sign test|||||||0.008
72516840|NCT02528253|144564389|SUPERIORITY||Odds Ratio (OR)|2.0||||0.0101|TWO_SIDED|95.0|1.18|3.39|||Regression, Logistic|||Week 2, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||3.39|1.18|0.0101
72516841|NCT02528253|144564389|SUPERIORITY||Odds Ratio (OR)|1.91||||0.0162|TWO_SIDED|95.0|1.13|3.25|||Regression, Logistic|||Week 2, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||3.25|1.13|0.0162
72568726|NCT01301508|144668597|SUPERIORITY_OR_OTHER|||||||0.017||||||p-value was calculated for the statistical significant difference between greater decrease in vehicle lesion and greater decrease in active lesion for the AN2728 Topical Ointment, 2% + Ointment Vehicle group.|Two-sided sign test|||||||0.017
72568727|NCT03123861|144668636|SUPERIORITY|||||||0.09|||||||t-test, 2 sided|||||||0.09
72568728|NCT03123861|144668637|SUPERIORITY|||||||0.09|||||||t-test, 2 sided|||||||0.09
72404673|NCT00004412|144316700|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.5||||0.05|TWO_SIDED||||||Fisher Exact|||Percentage of ulcers undergoing partial and complete healing compared at 12 weeks. Mean Ulcer areas were calculated utilizing computerized planimetry, ulcer area tracings, and photography for baseline and 12 weeks and compared between the two study Arms.||||0.05
72516842|NCT02528253|144564389|SUPERIORITY||Odds Ratio (OR)|1.17||||0.5599|TWO_SIDED|95.0|0.69|1.99|||Regression, Logistic|||Week 2, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.99|0.69|0.5599
72516843|NCT02528253|144564389|SUPERIORITY||Odds Ratio (OR)|1.71||||0.0202|TWO_SIDED|95.0|1.09|2.68|||Regression, Logistic|||Week 2, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||2.68|1.09|0.0202
72568729|NCT03123861|144668638|SUPERIORITY|||||||0.08|||||||t-test, 2 sided|||||||0.08
72568730|NCT03123861|144668639|SUPERIORITY|||||||0.91|||||||Wilcoxon (Mann-Whitney)|||||||0.91
72404674|NCT03144180|144316715|EQUIVALENCE|A two-sided two-sample t-test with 80% power, an alpha of 0.05, and a common standard deviation of 14 seconds was used to determine the sample size.|Confidence Interval for a mean|49.0|STANDARD_DEVIATION|47.0|||TWO_SIDED|95.0|15.459|82.571||||||||82.571|15.459|
72404675|NCT03144180|144316716|EQUIVALENCE|A two-sided two-sample t-test with 80% power, an alpha of 0.05, and a common standard deviation of 14 seconds was used to determine the sample size.||||||0.0295||||||The threshold for statistical significance was p = 0.05.|Chi-squared|||||||0.0295
72516844|NCT02528253|144564389|SUPERIORITY||Odds Ratio (OR)|1.64||||0.0335|TWO_SIDED|95.0|1.04|2.57|||Regression, Logistic|||Week 2, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||2.57|1.04|0.0335
72516845|NCT02528253|144564389|SUPERIORITY||Odds Ratio (OR)|2.53||||0.0416|TWO_SIDED|95.0|1.04|6.17|||Regression, Logistic|||Week 2, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||6.17|1.04|0.0416
72516846|NCT02528253|144564389|SUPERIORITY||Odds Ratio (OR)|3.24||||0.0075|TWO_SIDED|95.0|1.37|7.69|||Regression, Logistic|||Week 2, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||7.69|1.37|0.0075
72516847|NCT02528253|144564389|SUPERIORITY||Odds Ratio (OR)|1.33||||0.5374|TWO_SIDED|95.0|0.53|3.34|||Regression, Logistic|||Week 2, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||3.34|0.53|0.5374
72516848|NCT02528253|144564389|SUPERIORITY||Odds Ratio (OR)|1.89||||0.082|TWO_SIDED|95.0|0.92|3.89|||Regression, Logistic|||Week 2, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||3.89|0.92|0.0820
72516849|NCT02528253|144564389|SUPERIORITY||Odds Ratio (OR)|2.43||||0.0108|TWO_SIDED|95.0|1.23|4.81|||Regression, Logistic|||Week 2, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||4.81|1.23|0.0108
72516850|NCT02528253|144564389|SUPERIORITY||Odds Ratio (OR)|1.65||||0.0006|TWO_SIDED|95.0|1.24|2.2|||Regression, Logistic|||Week 4, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||2.20|1.24|0.0006
72516851|NCT02528253|144564389|SUPERIORITY||Odds Ratio (OR)|1.95|||<|0.0001|TWO_SIDED|95.0|1.47|2.59|||Regression, Logistic|||Week 4, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||2.59|1.47|<.0001
72516852|NCT02528253|144564389|SUPERIORITY||Odds Ratio (OR)|1.25||||0.0963|TWO_SIDED|95.0|0.96|1.63|||Regression, Logistic|||Week 4, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.63|0.96|0.0963
72516853|NCT02528253|144564389|SUPERIORITY||Odds Ratio (OR)|1.32||||0.0332|TWO_SIDED|95.0|1.02|1.71|||Regression, Logistic|||Week 4, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.71|1.02|0.0332
72516854|NCT02528253|144564389|SUPERIORITY||Odds Ratio (OR)|1.56||||0.0007|TWO_SIDED|95.0|1.21|2.01|||Regression, Logistic|||Week 4, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||2.01|1.21|0.0007
72516855|NCT02528253|144564389|SUPERIORITY||Odds Ratio (OR)|1.9||||0.0001|TWO_SIDED|95.0|1.37|2.64|||Regression, Logistic|||Week 4, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||2.64|1.37|0.0001
72516856|NCT02528253|144564389|SUPERIORITY||Odds Ratio (OR)|2.21|||<|0.0001|TWO_SIDED|95.0|1.6|3.05|||Regression, Logistic|||Week 4, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||3.05|1.60|<.0001
72516857|NCT02528253|144564389|SUPERIORITY||Odds Ratio (OR)|1.43||||0.0235|TWO_SIDED|95.0|1.05|1.95|||Regression, Logistic|||Week 4, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.95|1.05|0.0235
72516858|NCT02528253|144564389|SUPERIORITY||Odds Ratio (OR)|1.33||||0.0459|TWO_SIDED|95.0|1.01|1.76|||Regression, Logistic|||Week 4, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.76|1.01|0.0459
72516859|NCT02528253|144564389|SUPERIORITY||Odds Ratio (OR)|1.54||||0.002|TWO_SIDED|95.0|1.17|2.04|||Regression, Logistic|||Week 4, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||2.04|1.17|0.0020
72516860|NCT02528253|144564389|SUPERIORITY||Odds Ratio (OR)|1.93||||0.0019|TWO_SIDED|95.0|1.27|2.91|||Regression, Logistic|||Week 4, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||2.91|1.27|0.0019
72516861|NCT02528253|144564389|SUPERIORITY||Odds Ratio (OR)|2.42|||<|0.0001|TWO_SIDED|95.0|1.62|3.62|||Regression, Logistic|||Week 4, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||3.62|1.62|<.0001
72516862|NCT02528253|144564389|SUPERIORITY||Odds Ratio (OR)|1.09||||0.6765|TWO_SIDED|95.0|0.72|1.65|||Regression, Logistic|||Week 4, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.65|0.72|0.6765
72516863|NCT02528253|144564389|SUPERIORITY||Odds Ratio (OR)|1.76||||0.0022|TWO_SIDED|95.0|1.23|2.54|||Regression, Logistic|||Week 4, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||2.54|1.23|0.0022
72568731|NCT03512262|144668644|SUPERIORITY||Least Squares (LSM) Means Difference|7.3165|||<|0.0001|TWO_SIDED|99.0|5.0668|9.5663||Significance level of 0.01.|ANCOVA|Missing values were imputed using a multiple imputation method.||||9.5663|5.0668|<0.0001
72568732|NCT03512262|144668645|SUPERIORITY||LSM Difference|2.1209|||<|0.0001|TWO_SIDED|99.0|0.9948|3.2469||Significance level of 0.01.|ANCOVA|Missing values were imputed using a multiple imputation method.||||3.2469|0.9948|<0.0001
72568733|NCT03512262|144668646|SUPERIORITY||LSM Difference|2.8221|||<|0.0001|TWO_SIDED|99.0|1.3972|4.2471||Significance level of 0.01.|ANCOVA|Missing values were imputed using a multiple imputation method.||||4.2471|1.3972|<0.0001
72568734|NCT02307266|144668719|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3165|||||||Cochran-Mantel-Haenszel|||||||0.3165
72568735|NCT02307266|144668719|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0206|||||||Cochran-Mantel-Haenszel|||||||0.0206
72568736|NCT02766374|144668731|SUPERIORITY||||||>|0.1|||||||GEE regression|||||||>0.1
72568737|NCT05855616|144668760|OTHER||Odds Ratio (OR)|0.533||||1|TWO_SIDED|95.0|0.048|5.892|||t-test, 1 sided|||||5.892|0.048|1.00
72568738|NCT05855616|144668761|OTHER||Odds Ratio (OR)|0.176||||0.013|TWO_SIDED|95.0|0.039|0.79|||t-test, 1 sided|||||0.790|0.039|0.013
72624536|NCT01506726|144778753|SUPERIORITY_OR_OTHER|||||||0.232|TWO_SIDED||||||t-test, 2 sided|||||||0.232
72624537|NCT01506726|144778754|SUPERIORITY_OR_OTHER|||||||0.076|TWO_SIDED||||||t-test, 2 sided|||||||0.076
72624538|NCT01506726|144778755|SUPERIORITY_OR_OTHER||||||>|0.999|TWO_SIDED||||||Chi-squared|||||||>0.999
72568739|NCT05855616|144668763|OTHER|||||||0.137|||||||Chi-squared, Corrected|||||||0.137
72568740|NCT05855616|144668764|OTHER|||||||0.764|||||||Chi-squared, Corrected|||||||0.764
72568741|NCT05855616|144668765|OTHER|||||||0.055|||||||Chi-squared, Corrected|||||||0.055
72568742|NCT01796912|144668779|SUPERIORITY|||||||0.001|||||||t-test, 2 sided|||||||0.001
72568743|NCT01796912|144668780|SUPERIORITY|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||||||0.001
72568744|NCT01796912|144668781|SUPERIORITY|||||||0.14|||||||t-test, 2 sided|||||||0.14
72568745|NCT01796912|144668782|SUPERIORITY|||||||0.016|||||||t-test, 2 sided|||||||0.016
72568746|NCT01796912|144668783|SUPERIORITY|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||||||0.001
72568747|NCT01796912|144668784|SUPERIORITY|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||||||0.001
72568748|NCT01796912|144668785|SUPERIORITY|||||||0.005|||||||Wilcoxon (Mann-Whitney)|||||||0.005
72568749|NCT02920918|144668808|SUPERIORITY|||||||0.083|||||||ANOVA|||We expected a baseline peak oxygen consumption (VO2) of 14.5 mL/kg/min. A sample size of 40 patients per group (total of 80 patients) provided sufficient power to detect a mean difference in the interval change in peak VO2 of 1.50±1.76 mL/kg/min (primary endpoint) expected with Canagliflozin compared to Sitagliptin, which we predict to have no significant effect on peak VO2 (0±1.76 mL/kg/min).||||0.083
72568750|NCT02920918|144668809|SUPERIORITY|||||||0.51|||||||ANOVA|||||||0.51
72568751|NCT03537274|144668810|SUPERIORITY|||||||0.078|||||||Chi-squared|||||||0.078
72568752|NCT03537274|144668810|SUPERIORITY|||||||0.005|||||||Chi-squared|||||||0.005
72568753|NCT03537274|144668810|SUPERIORITY|||||||0.004|||||||Chi-squared|||||||0.004
72568754|NCT03537274|144668811|SUPERIORITY|||||||0.128|||||||Chi-squared|||||||0.128
72568755|NCT03537274|144668811|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
72568756|NCT03537274|144668811|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
72568757|NCT00974974|144668812|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||ANCOVA|||||||<.0001
72568758|NCT00974974|144668813|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||ANCOVA|||||||<.0001
72568759|NCT02836496|144668884|SUPERIORITY|||||||0.002||||||Cochran-Mantel-Haenszel test stratified by Baseline oral corticosteroid (OCS) (0-\<=20 mg per day and \>20mg perday prednisone or equivalent) and region|Cochran-Mantel-Haenszel|||||||0.002
72568760|NCT02836496|144668884|SUPERIORITY||Odds Ratio (OR)|0.28||||0.003|TWO_SIDED|95.0|0.12|0.64|||Regression, Logistic|Logistic regression analysis adjusted for Baseline OCS dose and region.|Treatment comparison between placebo and mepolizumab 300 mg using odds ratio and 95% confidence interval (CI) has been presented. Odds ratio \<1 indicated lower odds of HES flare with Mepolizumab compared with placebo.|||0.64|0.12|0.003
72568761|NCT02836496|144668885|SUPERIORITY|||||||0.02|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by Baseline OCS (0-\<=20 mg per day and \>20mg perday prednisone or equivalent) and region||||||0.020
72568762|NCT02836496|144668885|SUPERIORITY||Odds Ratio (OR)|0.33||||0.022|TWO_SIDED|95.0|0.13|0.85|||Regression, Logistic|Logistic regression analysis adjusted for Baseline OCS dose and region|Treatment comparison between placebo and mepolizumab 300 mg using odds ratio and 95% CI has been presented. Odds ratio \<1 indicated lower odds of HES flare with Mepolizumab compared with placebo.|||0.85|0.13|0.022
72624539|NCT01506726|144778756|SUPERIORITY_OR_OTHER|||||||0.187|TWO_SIDED||||||t-test, 2 sided|||||||0.187
72624540|NCT01506726|144778757|SUPERIORITY_OR_OTHER|||||||0.193|TWO_SIDED||||||t-test, 2 sided|||||||0.193
72624541|NCT01506726|144778758|SUPERIORITY_OR_OTHER|||||||0.619|TWO_SIDED||||||t-test, 2 sided|||||||0.619
72624542|NCT01506726|144778759|SUPERIORITY_OR_OTHER|||||||0.642|TWO_SIDED||||||t-test, 2 sided|||||||0.642
72624543|NCT01506726|144778760|SUPERIORITY_OR_OTHER|||||||0.42|TWO_SIDED||||||t-test, 2 sided|||||||0.42
72624544|NCT01506726|144778761|SUPERIORITY_OR_OTHER||||||>|0.999|TWO_SIDED||||||Chi-squared|||||||>0.999
72624545|NCT01506726|144778762|SUPERIORITY_OR_OTHER|||||||0.375|TWO_SIDED||||||Chi-squared|||||||0.375
72624546|NCT01506726|144778764|SUPERIORITY_OR_OTHER|||||||0.398|||||||t-test, 2 sided|||||||0.398
72624547|NCT01506726|144778765|SUPERIORITY_OR_OTHER|||||||0.412|||||||t-test, 2 sided|||||||0.412
72624548|NCT03863574|144778766|OTHER|Proof of Concept||||||0.7689|||||||t-test, 2 sided|||||||0.7689
72624549|NCT03863574|144778766|OTHER|Proof-of-concept||||||0.6007|||||||t-test, 2 sided|||||||0.6007
72624550|NCT03863574|144778767|OTHER|||||||0.5238|||||||Fisher Exact|||||||0.5238
72624551|NCT03863574|144778767|OTHER||||||>|0.9999|||||||Fisher Exact|||||||>0.9999
72624552|NCT03863574|144778768|OTHER|Proof-of-concept||||||0.0476|||||||Fisher Exact|||||||0.0476
72624553|NCT03863574|144778768|OTHER|Proof-of-concept||||||0.0333|||||||Fisher Exact|||||||0.0333
72624554|NCT03863574|144778769|OTHER|Proof-of-concept||||||0.6845|||||||t-test, 2 sided|||Outcome Variable: Steatosis||||0.6845
72624555|NCT03863574|144778769|OTHER|Proof-of-concept||||||0.4625|||||||t-test, 2 sided|||Outcome Variable: Steatosis||||0.4625
72624556|NCT03863574|144778769|OTHER|Proof-of-concept||||||0.1705|||||||t-test, 2 sided|||Outcome Variable: Lobular Inflammation||||0.1705
72624557|NCT03863574|144778769|OTHER|Proof-of-concept||||||0.3122|||||||t-test, 2 sided|||Outcome variable: Lobular Inflammation||||0.3122
72404676|NCT03144180|144316717|EQUIVALENCE|A two-sided two-sample t-test with 80% power, an alpha of 0.05, and a common standard deviation of 14 seconds was used to determine the sample size.||||||0.403||||||The threshold for statistical significance was p = 0.05.|Chi-squared|||||||0.403
72404677|NCT03663283|144316718|SUPERIORITY|||||||0.0197|||||||Wilcoxon (Mann-Whitney)|||||||.0197
72404678|NCT03663283|144316719|SUPERIORITY|||||||0.584|||||||Wilcoxon (Mann-Whitney)|||72 hours||||0.584
72404679|NCT03663283|144316719|SUPERIORITY|||||||0.58|||||||Wilcoxon (Mann-Whitney)|||3 weeks||||.5800
72568763|NCT02836496|144668886|SUPERIORITY||Hazard Ratio (HR)|0.34||||0.002|TWO_SIDED|95.0|0.18|0.67||Cox proportional hazards regression analysis adjusted for Baseline OCS dose and region.|Regression, Cox||Treatment comparison between placebo and mepolizumab 300 mg using hazards ratio and its corresponding 95% CI has been presented. Hazard ratio \<1 indicated a lower risk of HES flare with Mepolizumab compared with Placebo.|||0.67|0.18|0.002
72568764|NCT02836496|144668887|SUPERIORITY||Rate Ratio|0.34||||0.002|TWO_SIDED|95.0|0.19|0.63|||Wilcoxon Rank Sum Test|Wilcoxon test stratified by Baseline OCS (0-\<=20 mg/day, \>20 mg/day prednisone or equivalent) and region.|Treatment comparison between placebo and mepolizumab 300 mg using rate ratio and 95% CI has been presented. Rate ratio \<1 indicates a lower flare rate with Mepolizumab compared with Placebo.|||0.63|0.19|0.002
72568765|NCT02836496|144668888|SUPERIORITY|||||||0.036|||||||Wilcoxon Rank Sum Test|P-value was calculated using Wilcoxon Rank Sum Test||||||0.036
72568766|NCT03822832|144668889|OTHER||Mean Difference (Final Values)|-25.6|STANDARD_ERROR_OF_MEAN|17.4||0.1492|TWO_SIDED|90.0|-54.9|3.7|||Mixed Models Analysis|See endpoint description for model description.|Difference calculated as Spesolimab - Placebo.|||3.7|-54.9|0.1492
72568767|NCT03822832|144668891|OTHER||Mean Difference (Final Values)|0.7|STANDARD_ERROR_OF_MEAN|3.8||0.8613|TWO_SIDED|90.0|-5.7|7.0|||Mixed Models Analysis|See endpoint description for model description.|Difference calculated as Spesolimab - Placebo.|||7.0|-5.7|0.8613
72568768|NCT03822832|144668892|OTHER||Mean Difference (Final Values)|-2.2|STANDARD_ERROR_OF_MEAN|14.0||0.8754|TWO_SIDED|90.0|-25.8|21.4|||Mixed Models Analysis|See endpoint description for model description.|Difference calculated as Spesolimab - Placebo.|||21.4|-25.8|0.8754
72568769|NCT03822832|144668893|OTHER||Risk Difference (RD)|-0.03|||||TWO_SIDED|90.0|-0.254|0.176||||CIs are calculated using the method of Wilson and Newcombe.|Difference calculated as Spesolimab - Placebo|Risk difference at week 4||0.176|-0.254|
72404680|NCT03663283|144316720|SUPERIORITY|||||||0.11|||||||Log Rank|||||||0.11
72568770|NCT03822832|144668893|OTHER||Risk Difference (RD)|0.247|||||TWO_SIDED|90.0|0.053|0.396||||CIs are calculated using the method of Wilson and Newcombe.|Difference calculated as Spesolimab - Placebo|Risk difference at week 16||0.396|0.053|
72404681|NCT03663283|144316721|SUPERIORITY|||||||0.7018|||||||Wilcoxon (Mann-Whitney)|||72 hours||||.7018
72404682|NCT03663283|144316721|SUPERIORITY|||||||0.5327|||||||Wilcoxon (Mann-Whitney)|||Week 3||||.5327
72404683|NCT02346136|144316729|SUPERIORITY||Mean Difference (Net)|-0.12|STANDARD_ERROR_OF_MEAN|0.25||0.62|TWO_SIDED|95.0|-0.62|0.37||Tested as two-tailed p\<0.025 to accommodate two co-primary outcomes|Mixed Models Analysis|||||0.37|-0.62|0.62
72568771|NCT03822832|144668894|OTHER||Risk Difference (RD)|-0.02|||||TWO_SIDED|90.0|-0.204|0.117||||CIs are calculated using the method of Wilson and Newcombe.|Difference calculated as Spesolimab - Placebo|Risk difference at week 4||0.117|-0.204|
72568772|NCT03822832|144668894|OTHER||Risk Difference (RD)|0.096|||||TWO_SIDED|90.0|-0.08|0.232||||CIs are calculated using the method of Wilson and Newcombe.|Difference calculated as Spesolimab - Pl|Risk difference at week 16||0.232|-0.080|
72568773|NCT03822832|144668895|OTHER||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|8.7||0.99|TWO_SIDED|90.0|-14.6|14.8|||Mixed Models Analysis|See endpoint description for model description.|Difference calculated as Spesolimab - Placebo.|||14.8|-14.6|0.9900
72568774|NCT03822832|144668896|OTHER||Mean Difference (Final Values)|-14.9|STANDARD_ERROR_OF_MEAN|12.1||0.2266|TWO_SIDED|90.0|-35.2|5.5|||Mixed Models Analysis|See endpoint description for model description.|Difference calculated as Spesolimab - Placebo.|||5.5|-35.2|0.2266
72568775|NCT03822832|144668897|OTHER||Risk Difference (RD)|0.005|||||TWO_SIDED|90.0|-0.159|0.12||||CIs are calculated using the method of Wilson and Newcombe.|Difference calculated as Spesolimab - Placebo|Risk difference at week 4||0.120|-0.159|
72568776|NCT03822832|144668897|OTHER||Risk Difference (RD)|0.091|||||TWO_SIDED|90.0|-0.05|0.207||||CIs are calculated using the method of Wilson and Newcombe.|Difference calculated as Spesolimab - Placebo|Risk difference at week 16||0.207|-0.050|
72624558|NCT03863574|144778769|OTHER|Proof-of-concept||||||0.1705|||||||t-test, 2 sided|||Outcome Variable: Hepatocyte Ballooning||||0.1705
72624559|NCT03863574|144778769|OTHER|Proof-of-concept||||||0.3877|||||||t-test, 2 sided|||Outcome Variable: Hepatocyte Ballooning||||0.3877
72624560|NCT03863574|144778770|OTHER|Proof-of-concept||||||0.1705|||||||t-test, 2 sided|||||||0.1705
72624561|NCT03863574|144778770|OTHER|Proof-of-concept||||||0.174|||||||t-test, 2 sided|||||||0.1740
72404684|NCT02346136|144316730|SUPERIORITY||Risk Ratio (RR)|0.535||||0.194|TWO_SIDED|95.0|0.182|1.57|||Mixed Models Analysis|Mixed model Poisson reg with fixed effects of age, baseline SPPB, baseline CES-D, and falls in prev year and random intercept and trt by site pair|Numerator of risk ratio is the rate among participants at sites receiving Tai Chi. Denominator of risk ratio is the rate among participants at sites receiving Health Education.|||1.57|0.182|0.194
72404685|NCT02346136|144316731|SUPERIORITY||Mean Difference (Net)|-0.65|STANDARD_ERROR_OF_MEAN|0.94||0.5|TWO_SIDED|95.0|-2.53|1.24|||Mixed Models Analysis|||||1.24|-2.53|.50
72404686|NCT02346136|144316732|SUPERIORITY||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|0.02||0.85|TWO_SIDED|95.0|-0.04|0.05|||Mixed Models Analysis|||Gait NW velocity variable||.05|-.04|.85
72404687|NCT02346136|144316732|SUPERIORITY||Mean Difference (Net)|0.02|STANDARD_ERROR_OF_MEAN|0.02||0.26|TWO_SIDED|95.0|-0.02|0.06|||Mixed Models Analysis|||Gait DT velocity variable||.06|-.02|.26
72404688|NCT02346136|144316733|SUPERIORITY||Mean Difference (Net)|-0.004|STANDARD_ERROR_OF_MEAN|0.02||0.84|TWO_SIDED|95.0|-0.04|0.03|||Mixed Models Analysis|||||0.03|-0.04|0.84
72404689|NCT02346136|144316734|SUPERIORITY||Mean Difference (Net)|0.81|STANDARD_ERROR_OF_MEAN|0.71||0.26|TWO_SIDED|95.0|-0.61|2.22|||Mixed Models Analysis|||||2.22|-0.61|.26
72404690|NCT02346136|144316735|SUPERIORITY||Median Difference (Net)|0.72|STANDARD_ERROR_OF_MEAN|7.29||0.92|TWO_SIDED|95.0|-13.9|15.3|||Mixed Models Analysis|||||15.3|-13.9|.92
72404691|NCT02346136|144316736|SUPERIORITY||Median Difference (Net)|1.36|STANDARD_ERROR_OF_MEAN|9.28||0.88|TWO_SIDED|95.0|-17.2|19.9|||Mixed Models Analysis|||||19.9|-17.2|.88
72568777|NCT00158600|144668952|SUPERIORITY_OR_OTHER||Difference|28.12||||0.0347||95.0|2.07|54.17||The threshold for determining statistical significance is 0.05. A fixed testing sequence procedure was used to preserve an overall error rate of 5% for the co-primary efficacy endpoints by linking the test of FVC to the result of 6MWT.|ANCOVA|||The difference between alglucosidase alfa and placebo treatment groups in change in distance walked from baseline to last observation was estimated by ANCOVA after adjusting for baseline value and randomization strata.||54.17|2.07|0.0347
72568778|NCT00158600|144668953|SUPERIORITY_OR_OTHER||Difference|3.4||||0.0055||95.0|1.03|5.77||The threshold for determining statistical significance is 0.05. A fixed testing sequence procedure was used to preserve an overall error rate of 5% for the co-primary efficacy endpoints by linking the test of FVC to the result of 6MWT.|ANCOVA|||The difference between alglucosidase alfa and placebo treatment groups in change in % predicted FVC from baseline to last observation was estimated by ANCOVA after adjusting for baseline value and randomization strata.||5.77|1.03|0.0055
72568779|NCT00158600|144668954|SUPERIORITY_OR_OTHER||Difference|3.18||||0.1093||95.0|-0.73|7.08||The threshold for determining statistical significance is 0.05. No adjustment for multiple comparison was made for secondary efficacy endpoints.|ANCOVA|||The difference between alglucosidase alfa and placebo treatment groups in change in QMT from baseline to last observation was estimated by ANCOVA after adjusting for baseline value and randomization strata.||7.08|-0.73|0.1093
72568780|NCT00158600|144668955|SUPERIORITY_OR_OTHER||Difference|-0.37||||0.8333||95.0|-3.83|3.09||The threshold for determining statistical significance is 0.05. No adjustment for multiple comparison was made for secondary efficacy endpoints.|ANCOVA|||The difference between alglucosidase alfa and placebo treatment groups in change in PCS from baseline to last observation was estimated by ANCOVA after adjusting for baseline value and randomization strata.||3.09|-3.83|0.8333
72568781|NCT02737332|144668959|EQUIVALENCE|The bioequivalence between the two products was concluded if the 90% CIs (based on log transformed data and anti-logged) for the ratio of the geometric means lie completely within the range 80%-125%.|Geometric mean ratio of treatments|1.019||||0.4879|TWO_SIDED|90.0|0.964|1.077||One-way ANOVA model with treatment as the independent variable, and the least-square means and standard error of Testosterone levels under each treatment and the between-treatment difference in LS means was reported.|ANOVA||Geometric mean ratio of experimental and reference product was determined by exponentiating least-squares means of log-transformed value.|||1.077|0.964|0.4879
72568782|NCT02737332|144668960|OTHER|The bioequivalence between the two products was concluded if the 90% CIs (based on log transformed data and anti-logged) for the ratio of the geometric means lie completely within the range 80%-125%.|Geometric mean ratio|0.994||||0.3642|TWO_SIDED|90.0|0.0451|2.192||One-way ANOVA model with treatment as the independent variable, and the least-square means and standard error of Testosterone levels under each treatment and the between-treatment difference in LS means was reported.|ANOVA||Geometric mean ratio of experimental and reference product was determined by exponentiating least-squares means of log-transformed value.|||2.192|0.0451|0.3642
72568783|NCT02737332|144668960|EQUIVALENCE|The bioequivalence between the two products was concluded if the 90% CIs (based on log transformed data and anti-logged) for the ratio of the geometric means lie completely within the range 80%-125%.|Geometric mean ratio|0.81||||0.4069|TWO_SIDED|90.0|0.338|1.939||One-way ANOVA model with treatment as the independent variable, and the least-square means and standard error of Testosterone levels under each treatment and the between-treatment difference in LS means was reported.|ANOVA||Geometric mean ratio of experimental and reference product was determined by exponentiating least-squares means of log-transformed value.|||1.939|0.338|0.4069
72568784|NCT02737332|144668960|EQUIVALENCE|One-way ANOVA model with treatment as the independent variable, and the least-square means and standard error of Testosterone levels under each treatment and the between-treatment difference in LS means was reported.|Geometric mean ratio|1.039||||0.7186|TWO_SIDED|90.0|0.412|2.617||The bioequivalence between the two products was concluded if the 90% CIs (based on log transformed data and anti-logged) for the ratio of the geometric means lie completely within the range 80%-125%.|ANOVA||Geometric mean ratio of experimental and reference product was determined by exponentiating least-squares means of log-transformed value.|||2.617|0.412|0.7186
72568785|NCT02737332|144668961|OTHER|||||||1|||||||Fisher Exact|||||||1.0000
72568786|NCT02737332|144668962|EQUIVALENCE|The bioequivalence between the two products was concluded if the 90% CIs (based on log transformed data and anti-logged) for the ratio of the geometric means lie completely within the range 80%-125%.|Geometric mean ratio|0.999||||0.9211|TWO_SIDED|90.0|0.98|1.018||One-way ANOVA model with treatment as the independent variable, and the least-square means and standard error of Testosterone levels under each treatment and the between-treatment difference in LS means was reported.|ANOVA||Geometric mean ratio of experimental and reference product was determined by exponentiating least-squares means of log-transformed value.||ANOVA-model-based Least-Square Mean|1.018|0.980|0.9211
72568787|NCT02737332|144668962|EQUIVALENCE|The bioequivalence between the two products was concluded if the 90% CIs (based on log transformed data and anti-logged) for the ratio of the geometric means lie completely within the range 80%-125%.|Geometric mean ratio|1.168||||0.3037|TWO_SIDED|90.0|0.9|1.515||One-way ANOVA model with treatment as the independent variable, and the least-square means and standard error of Testosterone levels under each treatment and the between-treatment difference in LS means was reported.|ANOVA||Geometric mean ratio of experimental and reference product was determined by exponentiating least-squares means of log-transformed value.|||1.515|0.900|0.3037
72568788|NCT02737332|144668962|EQUIVALENCE|The bioequivalence between the two products was concluded if the 90% CIs (based on log transformed data and anti-logged) for the ratio of the geometric means lie completely within the range 80%-125%.|Geometric mean ratio|1.0|||||TWO_SIDED|90.0|1.0|1.0||One-way ANOVA model with treatment as the independent variable, and the least-square means and standard error of Testosterone levels under each treatment and the between-treatment difference in LS means was reported.|ANOVA||Geometric mean ratio of experimental and reference product was determined by exponentiating least-squares means of log-transformed value.|||1.000|1.000|
72568789|NCT02737332|144668963|OTHER|||||||0.5495|||||||ANOVA|||||||0.5495
72404692|NCT02346136|144316737|SUPERIORITY||Mean Difference (Net)|0.85|STANDARD_ERROR_OF_MEAN|1.43||0.55|TWO_SIDED|95.0|-2.0|3.71|||Mixed Models Analysis|||Physical component score||3.71|-2.00|.55
72404693|NCT02346136|144316737|SUPERIORITY||Mean Difference (Net)|-1.1|STANDARD_ERROR_OF_MEAN|1.66||0.51|TWO_SIDED|95.0|-4.41|2.21|||Mixed Models Analysis|||Mental component score||2.21|-4.41|.51
72490587|NCT02873936|144508825|SUPERIORITY||Least Squares Mean Difference|-0.32|STANDARD_ERROR_OF_MEAN|0.066|<|0.001|TWO_SIDED|95.0|-0.45|-0.19||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 12. Least squares (LS)-Mean, 95% confidence interval (CI), and P-value were provided from mixed effects model for repeated measure (MMRM). Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.19|-0.45|<0.001
72490588|NCT02873936|144508825|SUPERIORITY||Least Squares Mean Difference|-0.27|STANDARD_ERROR_OF_MEAN|0.065|<|0.001|TWO_SIDED|95.0|-0.4|-0.14||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.14|-0.40|<0.001
72490589|NCT02873936|144508826|SUPERIORITY||Difference in Response Rates|25.3|||<|0.001|TWO_SIDED|95.0|14.7|35.8||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg vs Placebo at Week 12||35.8|14.7|<0.001
72490590|NCT02873936|144508826|SUPERIORITY||Difference in Response Rates|21.7|||<|0.001|TWO_SIDED|95.0|11.4|32.0||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg vs Placebo at Week 12||32.0|11.4|<0.001
72490591|NCT02873936|144508827|SUPERIORITY||Least Squares Mean Difference|4.3|STANDARD_ERROR_OF_MEAN|0.92|<|0.001|TWO_SIDED|95.0|2.5|6.1||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||6.1|2.5|<0.001
72568790|NCT02737332|144668963|OTHER|||||||0.2616|||||||ANOVA|||||||0.2616
72568791|NCT02737332|144668963|OTHER|||||||0.3632|||||||ANOVA|||||||0.3632
72490592|NCT02873936|144508827|SUPERIORITY||Least Squares Mean Difference|3.4|STANDARD_ERROR_OF_MEAN|0.92|<|0.001|TWO_SIDED|95.0|1.6|5.2||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||5.2|1.6|<0.001
72490593|NCT02873936|144508828|SUPERIORITY||Difference in Response Rates|18.5|||<|0.001|TWO_SIDED|95.0|8.6|28.3||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg vs Placebo at Week 24||28.3|8.6|<0.001
72490594|NCT02873936|144508828|SUPERIORITY||Difference in Response Rates|14.0||||0.003|TWO_SIDED|95.0|4.6|23.4||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg vs Placebo at Week 24||23.4|4.6|0.003
72568792|NCT02737332|144668963|OTHER|||||||0.3393|||||||ANOVA|||||||0.3393
72568793|NCT02737332|144668967|OTHER|||||||0.1917|||||||ANOVA|||||||0.1917
72568794|NCT02618408|144668971|SUPERIORITY||Median Difference (Net)|-7.08||||0.0916|TWO_SIDED|95.0|-15.38|1.22|||Wilcoxon (Mann-Whitney)|||||1.22|-15.38|0.0916
72490595|NCT02873936|144508829|SUPERIORITY||Least Squares Mean Difference|5.0|STANDARD_ERROR_OF_MEAN|1.19|<|0.001|TWO_SIDED|95.0|2.6|7.3||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||7.3|2.6|<0.001
72568795|NCT02618408|144668971|SUPERIORITY||Median Difference (Net)|-1.76||||0.7136|TWO_SIDED|95.0|-11.78|8.27|||Wilcoxon (Mann-Whitney)|||Based on the results of a prespecified interim analysis, the enrollment of the low dose SPN-810 arm was halted, and this treatment arm was dropped. Accordingly, all analysis of primary and secondary endpoints focused on the comparison of SPN-810 high dose and placebo||8.27|-11.78|0.7136
72404694|NCT02346136|144316738|SUPERIORITY||Median Difference (Net)|0.4|STANDARD_ERROR_OF_MEAN|1.0||0.69|TWO_SIDED|95.0|-1.6|2.41|||Mixed Models Analysis|||||2.41|-1.60|.69
72404695|NCT02346136|144316739|SUPERIORITY||Mean Difference (Net)|2.14|STANDARD_ERROR_OF_MEAN|2.56||0.41|TWO_SIDED|95.0|-2.98|7.26||to accommodate two co-primary outcomes|Mixed Models Analysis|||||7.26|-2.98|0.41
72404696|NCT02346136|144316741|SUPERIORITY||Risk Ratio (RR)|0.476||||0.06|TWO_SIDED|95.0|0.216|1.05|||Mixed Models Analysis|Mixed model Poisson reg with fixed effects of age, baseline SPPB, baseline CES-D, and falls in prev year and random intercept and trt by site pair|Numerator of risk ratio is the rate among participants at sites receiving Tai Chi. Denominator of risk ratio is the rate among participants at sites receiving Health Education.|||1.05|0.216|0.060
72404697|NCT02346136|144316742|SUPERIORITY||Mean Difference (Net)|1.27|STANDARD_ERROR_OF_MEAN|0.81||0.13|TWO_SIDED|95.0|-0.4|2.94|||Mixed Models Analysis|||||2.94|-0.40|0.13
72490596|NCT02873936|144508829|SUPERIORITY||Least Squares Mean Difference|3.2|STANDARD_ERROR_OF_MEAN|1.18||0.007|TWO_SIDED|95.0|0.9|5.5||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||5.5|0.9|0.007
72490597|NCT02873936|144508830|SUPERIORITY||Difference in Response Rates|15.0|||<|0.001|TWO_SIDED|95.0|6.4|23.7||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg vs Placebo at Week 4||23.7|6.4|<0.001
72490598|NCT02873936|144508830|SUPERIORITY||Difference in Response Rates|14.1|||<|0.001|TWO_SIDED|95.0|5.7|22.6||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg vs Placebo at Week 4||22.6|5.7|<0.001
72490599|NCT02873936|144508830|SUPERIORITY||Difference in Response Rates|28.0|||<|0.001|TWO_SIDED|95.0|17.5|38.5||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg vs Placebo at Week 12||38.5|17.5|<0.001
72490600|NCT02873936|144508830|SUPERIORITY||Difference in Response Rates|17.2|||<|0.001|TWO_SIDED|95.0|7.1|27.2||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg vs Placebo at Week 12||27.2|7.1|<0.001
72490601|NCT02873936|144508830|SUPERIORITY||Difference in Response Rates|26.7|||<|0.001|TWO_SIDED|95.0|15.8|37.6||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg vs Placebo at Week 24||37.6|15.8|<0.001
72516864|NCT02528253|144564389|SUPERIORITY||Odds Ratio (OR)|2.21|||<|0.0001|TWO_SIDED|95.0|1.56|3.15|||Regression, Logistic|||Week 4, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||3.15|1.56|<.0001
72516865|NCT02528253|144564389|SUPERIORITY||Odds Ratio (OR)|1.98||||0.027|TWO_SIDED|95.0|1.08|3.63|||Regression, Logistic|||Week 4, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||3.63|1.08|0.0270
72624562|NCT03863574|144778771|OTHER|Proof-of-concept||||||0.8019|||||||t-test, 2 sided|||Outcome variable: Alanine Aminotransferase||||0.8019
72490602|NCT02873936|144508830|SUPERIORITY||Difference in Response Rates|16.4||||0.002|TWO_SIDED|95.0|5.9|26.9||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg vs Placebo at Week 24||26.9|5.9|0.002
72490603|NCT02873936|144508831|SUPERIORITY||Difference in Response Rates|3.4||||0.16|TWO_SIDED|95.0|-1.9|8.8||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg vs Placebo at Week 4||8.8|-1.9|0.16
72490604|NCT02873936|144508831|SUPERIORITY||Difference in Response Rates|5.8||||0.039|TWO_SIDED|95.0|0.0|11.6||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg vs Placebo at Week 4||11.6|-0.0|0.039
72490605|NCT02873936|144508831|SUPERIORITY||Difference in Response Rates|15.0|||<|0.001|TWO_SIDED|95.0|6.5|23.5||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg vs Placebo at Week 12||23.5|6.5|<0.001
72490606|NCT02873936|144508831|SUPERIORITY||Difference in Response Rates|7.6||||0.036|TWO_SIDED|95.0|0.1|15.2||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg vs Placebo at Week 12||15.2|0.1|0.036
72490607|NCT02873936|144508831|SUPERIORITY||Difference in Response Rates|23.9|||<|0.001|TWO_SIDED|95.0|14.5|33.3||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg vs Placebo at Week 24||33.3|14.5|<0.001
72490608|NCT02873936|144508831|SUPERIORITY||Difference in Response Rates|12.2||||0.004|TWO_SIDED|95.0|3.7|20.6||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg vs Placebo at Week 24||20.6|3.7|0.004
72516866|NCT02528253|144564389|SUPERIORITY||Odds Ratio (OR)|2.43||||0.003|TWO_SIDED|95.0|1.35|4.38|||Regression, Logistic|||Week 4, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||4.38|1.35|0.0030
72568796|NCT02618408|144668972|SUPERIORITY|This analysis pertains to Visit 4|Mean Difference (Net)|-0.25|STANDARD_ERROR_OF_MEAN|0.108||0.0238|TWO_SIDED|95.0|-0.46|-0.03|||Mixed Models Analysis|||||-0.03|-0.46|0.0238
72568797|NCT02618408|144668972|SUPERIORITY||Mean Difference (Net)|-0.23|STANDARD_ERROR_OF_MEAN|0.123||0.0683|TWO_SIDED|95.0|-0.47|0.02|||Mixed Models Analysis|||This analysis pertains to Visit 5||0.02|-0.47|0.0683
72568798|NCT02618408|144668972|SUPERIORITY||Mean Difference (Net)|-0.24|STANDARD_ERROR_OF_MEAN|0.136||0.0742|TWO_SIDED|95.0|-0.51|0.02|||Mixed Models Analysis|||This analysis pertains to Visit 6||0.02|-0.51|0.0742
72568799|NCT02618408|144668973|SUPERIORITY|This analysis pertains to Visit 4|Mean Difference (Net)|-0.09|STANDARD_ERROR_OF_MEAN|0.105||0.3713|TWO_SIDED|95.0|-0.3|0.11|||Mixed Models Analysis|||||0.11|-0.30|0.3713
72568800|NCT02618408|144668973|SUPERIORITY||Mean Difference (Net)|-0.2|STANDARD_ERROR_OF_MEAN|0.131||0.1367|TWO_SIDED|95.0|-0.45|0.06|||Mixed Models Analysis|||This analysis pertains to Visit 5||0.06|-0.45|0.1367
72568801|NCT02618408|144668973|SUPERIORITY||Median Difference (Net)|-0.2|STANDARD_ERROR_OF_MEAN|0.146||0.1729|TWO_SIDED|95.0|-0.49|0.09|||Mixed Models Analysis|||This analysis pertains to Visit 6||0.09|-0.49|0.1729
72568802|NCT02618408|144668974|SUPERIORITY||Mean Difference (Net)|2.15|STANDARD_ERROR_OF_MEAN|1.456||0.1407|TWO_SIDED|95.0|-0.72|5.02|||ANCOVA|||This analysis pertains to the physical functioning summary score at Visit 6.||5.02|-0.72|0.1407
72568803|NCT02618408|144668974|SUPERIORITY||Mean Difference (Net)|-0.53|STANDARD_ERROR_OF_MEAN|0.898||0.5586|TWO_SIDED|95.0|-2.29|1.24|||ANCOVA|||This analysis pertains to the psychosocial health summary score at Visit 6||1.24|-2.29|0.5586
72568804|NCT02618408|144668975|SUPERIORITY||Median Difference (Net)|-0.62|STANDARD_ERROR_OF_MEAN|2.07||0.7637|TWO_SIDED|95.0|-4.7|3.45|||ANCOVA|||This analysis pertains to the Total Stress summary score Visit 6.||3.45|-4.70|0.7637
72568805|NCT02618408|144668975|SUPERIORITY||Mean Difference (Net)|-0.18|STANDARD_ERROR_OF_MEAN|0.895||0.8365|TWO_SIDED|95.0|-1.95|1.58|||ANCOVA|||This analysis pertains to the Parental Distress Domain score at Visit 6.||1.58|-1.95|0.8365
72568806|NCT02618408|144668975|SUPERIORITY||Mean Difference (Net)|-0.61|STANDARD_ERROR_OF_MEAN|0.829||0.4606|TWO_SIDED|95.0|-2.24|1.02|||ANCOVA|||This analysis pertains to the Parent-Child Dysfunctional Interaction score at Visit 6.||1.02|-2.24|0.4606
72404698|NCT04180020|144316798|SUPERIORITY|||||||0.94|||||||t-test, 2 sided|||||||0.94
72404699|NCT03274986|144316841|SUPERIORITY||Least Squares Mean Difference|-0.164|STANDARD_ERROR_OF_MEAN|0.0168|<|0.001|TWO_SIDED|95.0|-0.197|-0.131||2-sided p-value reported. A hypothesis test was based on a two sample t-test, with a type I error rate of 0.025, 1-sided.|t-test, 2 sided||Least squares mean difference (DFT015 - SN60WF)|||-0.131|-0.197|<0.001
72568807|NCT02618408|144668975|SUPERIORITY||Mean Difference (Net)|-0.19|STANDARD_ERROR_OF_MEAN|0.837||0.8222|TWO_SIDED|95.0|-1.84|1.46|||ANCOVA|||This analysis pertains to the Difficult Child Domain score Visit 6.||1.46|-1.84|0.8222
72568808|NCT02618408|144668976|SUPERIORITY|This analysis pertains to Visit 4|Mean Difference (Net)|-0.2|STANDARD_ERROR_OF_MEAN|0.121||0.1031|TWO_SIDED|95.0|-0.43|0.04|||Mixed Models Analysis|||||0.04|-0.43|0.1031
72568809|NCT02618408|144668976|SUPERIORITY|This analysis pertains to Visit 5|Mean Difference (Net)|-0.3|STANDARD_ERROR_OF_MEAN|0.132||0.025|TWO_SIDED|95.0|-0.56|-0.04|||Mixed Models Analysis|||||-0.04|-0.56|0.0250
72568810|NCT02618408|144668976|SUPERIORITY|This analysis pertains to Visit 6|Mean Difference (Net)|-0.33|STANDARD_ERROR_OF_MEAN|0.158||0.0384|TWO_SIDED|95.0|-0.64|-0.02|||Mixed Models Analysis|||||-0.02|-0.64|0.0384
72568811|NCT02618408|144668977|SUPERIORITY||Mean Difference (Net)|-0.11|STANDARD_ERROR_OF_MEAN|0.084||0.1935|TWO_SIDED|95.0|-0.27|0.06|||ANCOVA|||This analysis pertains to the inattention subscale at Visit 6.||0.06|-0.27|0.1935
72568812|NCT02618408|144668977|SUPERIORITY||Mean Difference (Net)|-0.13|STANDARD_ERROR_OF_MEAN|0.092||0.1445|TWO_SIDED|95.0|-0.32|0.05|||ANCOVA|||This analysis pertains to hyperactivity/Impulsivity subscale at Visit 6||0.05|-0.32|0.1445
72568813|NCT02618408|144668977|SUPERIORITY||Mean Difference (Net)|-0.16|STANDARD_ERROR_OF_MEAN|0.1||0.1064|TWO_SIDED|95.0|-0.36|0.03|||ANCOVA|||This analysis pertains to the oppositional defiant disorder subscale at Visit 6||0.03|-0.36|0.1064
72568814|NCT02618408|144668977|SUPERIORITY||Mean Difference (Net)|-0.12|STANDARD_ERROR_OF_MEAN|0.082||0.1418|TWO_SIDED|95.0|-0.28|0.04|||ANCOVA|||This analysis pertains to the combined scale score at Visit 6||0.04|-0.28|0.1418
72568815|NCT04492020|144668978|SUPERIORITY||Odds Ratio (OR)|2.09|||<|0.0001|TWO_SIDED|95.0|1.63|2.69|||generalized linear mixed model (GLMM)|||||2.69|1.63|<.0001
72568816|NCT04492020|144668979|SUPERIORITY||Odds Ratio (OR)|2.13|||<|0.0001|TWO_SIDED|95.0|1.63|2.78|||generalized linear mixed model (GLMM)|||||2.78|1.63|<.0001
72568817|NCT04492020|144668980|SUPERIORITY||Geometric Mean Odds Ratio|1.66|||<|0.0001|TWO_SIDED|95.0|1.4|1.96|||generalized estimating equation (GEE)|||||1.96|1.40|<.0001
72568818|NCT04492020|144668981|SUPERIORITY||Odds Ratio (OR)|1.93|||<|0.0001|TWO_SIDED|95.0|1.39|2.66|||generalized linear mixed model (GLMM)|||||2.66|1.39|<.0001
72568819|NCT04972123|144668991|SUPERIORITY|The primary end point was evaluated via a large sample Z-test for proportions. The test statistic was compared to a Pocock monitoring boundary at both an interim analysis and at the final analysis.||||||0.521||||||The primary end point was evaluated via a large sample Z-test for proportions. The test statistic was compared to a Pocock monitoring boundary at both an interim analysis and at the final analysis.|Large sample Z-test for population prop|The test statistic was compared to a Pocock monitoring boundary at both an interim analysis and at the final analysis.||Primary endpoint -- ITT primary endpoint analysis||||0.521
72568820|NCT04972123|144668992|SUPERIORITY|Time to event was compared between groups via a log-rank test.||||||0.574||||||Time to event was compared between groups via a log-rank test.|Log Rank|||Secondary endpoint -- Time to event for evaluable ITT population who had a primary event.||||0.574
72568821|NCT04972123|144668993|SUPERIORITY|Incidence of asystole were compared between groups using Fisher exact test.||||||1||||||Incidence of asystole were compared between groups using Fisher exact test.|Fisher Exact|Incidence of asystole were compared between groups using Fisher exact test.||Secondary endpoint -- Incidence of asystolic pause \> 3 seconds for evaluable ITT population who had a primary event.||||1.000
72568822|NCT04972123|144668994|SUPERIORITY|Reporting for the 1 hour fatigue score only.||||||0.732||||||Measures of fatigue were compared between groups using the Wilcoxon rank-sum test.|Wilcoxon (Mann-Whitney)|Measures of fatigue were compared between groups using the Wilcoxon rank-sum test.||Secondary endpoint -- Measures of Fatigue for evaluable ITT population who had a primary event.||||0.732
72624563|NCT03863574|144778771|OTHER|Proof-of-concept||||||0.5396|||||||t-test, 2 sided|||Outcome Variable: Alanine Aminotransferase||||0.5396
72490609|NCT02873936|144508832|SUPERIORITY||Difference in Response Rates|26.0|||<|0.001|TWO_SIDED|95.0|14.6|37.4||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg vs Placebo at Week 4||37.4|14.6|<0.001
72624564|NCT03863574|144778771|OTHER|Proof-of-concept||||||0.774|||||||t-test, 2 sided|||Outcome Variable: Aspartate Aminotransferase||||0.7740
72624565|NCT03863574|144778771|OTHER|Proof-of-concept||||||0.9221|||||||t-test, 2 sided|||Outcome Variable: Aspartate Aminotransferase||||0.9221
72404700|NCT03274986|144316842|NON_INFERIORITY|Non-Inferiority margin was 0.1 logMAR.|Least Squares Mean Difference|0.052|STANDARD_ERROR_OF_MEAN|0.0127|||ONE_SIDED|95.0||0.073||The hypothesis test was based on a two-sample t-test, with a type I error rate of 0.05, 1-sided.|t-test, 2 sided||Least squares mean difference (DFT015 - SN60WF). The 1-sided 95% Upper Confidence Limit is presented.|||0.073||
72490610|NCT02873936|144508832|SUPERIORITY||Difference in Response Rates|18.8|||<|0.001|TWO_SIDED|95.0|7.5|30.0||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg vs Placebo at Week 4||30.0|7.5|<0.001
72490611|NCT02873936|144508832|SUPERIORITY||Difference in Response Rates|34.9|||<|0.001|TWO_SIDED|95.0|23.6|46.3||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg vs Placebo at Week 24||46.3|23.6|<0.001
72490612|NCT02873936|144508832|SUPERIORITY||Difference in Response Rates|20.4|||<|0.001|TWO_SIDED|95.0|8.8|32.1||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg vs Placebo at Week 24||32.1|8.8|<0.001
72490613|NCT02873936|144508833|SUPERIORITY||Least Squares Mean Difference|-4.0|STANDARD_ERROR_OF_MEAN|1.4||0.003|TWO_SIDED|95.0|-7.0|-1.0||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-1.0|-7.0|0.003
72490614|NCT02873936|144508833|SUPERIORITY||Least Squares Mean Difference|-3.0|STANDARD_ERROR_OF_MEAN|1.4||0.027|TWO_SIDED|95.0|-6.0|0.0||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.0|-6.0|0.027
72490615|NCT02873936|144508833|SUPERIORITY||Least Squares Mean Difference|-6.0|STANDARD_ERROR_OF_MEAN|1.3|<|0.001|TWO_SIDED|95.0|-8.0|-3.0||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-3.0|-8.0|<0.001
72490616|NCT02873936|144508833|SUPERIORITY||Least Squares Mean Difference|-4.0|STANDARD_ERROR_OF_MEAN|1.3|<|0.001|TWO_SIDED|95.0|-7.0|-2.0||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-2.0|-7.0|<0.001
72490617|NCT02873936|144508833|SUPERIORITY||Least Squares Mean Difference|-7.0|STANDARD_ERROR_OF_MEAN|1.5|<|0.001|TWO_SIDED|95.0|-10.0|-4.0||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-4.0|-10.0|<0.001
72490618|NCT02873936|144508833|SUPERIORITY||Least Squares Mean Difference|-4.0|STANDARD_ERROR_OF_MEAN|1.5||0.006|TWO_SIDED|95.0|-7.0|-1.0||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-1.0|-7.0|0.006
72490619|NCT02873936|144508834|SUPERIORITY||Least Squares Mean Difference|-3.0|STANDARD_ERROR_OF_MEAN|1.0||0.008|TWO_SIDED|95.0|-5.0|-1.0||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-1.0|-5.0|0.008
72624566|NCT03863574|144778771|OTHER|Proof-of-concept||||||0.003|||||||t-test, 2 sided|||Outcome Variable: Alkaline Phosphatase||||0.0030
72624567|NCT03863574|144778771|OTHER|Proof-of-concept||||||0.0177|||||||t-test, 2 sided|||Outcome Variable: Alkaline Phosphatase||||0.0177
72624568|NCT03863574|144778771|OTHER|Proof-of-concept||||||0.1399|||||||t-test, 2 sided|||Outcome Variable: Gamma Glutamyl Transferase||||0.1399
72624569|NCT03863574|144778771|OTHER|Proof-of-concept||||||0.2384|||||||t-test, 2 sided|||Outcome Variable: Gamma Glutamyl Transferase||||0.2384
72624570|NCT03863574|144778772|OTHER|Proof-of-concept||||||0.2218|||||||t-test, 2 sided|||Outcome Variable: Albumin||||0.2218
72624571|NCT03863574|144778772|OTHER|Proof-of-Concept||||||0.1483|||||||t-test, 2 sided|||Outcome Variable: Albumin||||0.1483
72624572|NCT03863574|144778772|OTHER|Proof-of-concept||||||0.0839|||||||t-test, 2 sided|||Outcome Variable: Total Protein||||0.0839
72624573|NCT03863574|144778772|OTHER|Proof-of-concept||||||0.2895|||||||t-test, 2 sided|||Outcome Variable: Total Protein||||0.2895
72624574|NCT03863574|144778773|OTHER|Proof-of-concept||||||0.6808|||||||t-test, 2 sided|||Outcome Variable: Direct Bilirubin||||0.6808
72624575|NCT03863574|144778773|OTHER|Proof-of-concept||||||0.5351|||||||t-test, 2 sided|||Outcome Variable: Direct Bilirubin||||0.5351
72624576|NCT03863574|144778774|OTHER|Proof-of-concept||||||0.2329|||||||t-test, 2 sided|||Outcome Variable: Triglyceride||||0.2329
72490620|NCT02873936|144508834|SUPERIORITY||Least Squares Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|1.0||0.65|TWO_SIDED|95.0|-2.0|1.0||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||1.0|-2.0|0.65
72490621|NCT02873936|144508834|SUPERIORITY||Least Squares Mean Difference|-4.0|STANDARD_ERROR_OF_MEAN|0.9|<|0.001|TWO_SIDED|95.0|-5.0|-2.0||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-2.0|-5.0|<0.001
72490622|NCT02873936|144508834|SUPERIORITY||Least Squares Mean Difference|-2.0|STANDARD_ERROR_OF_MEAN|0.9||0.008|TWO_SIDED|95.0|-4.0|-1.0||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-1.0|-4.0|0.008
72490623|NCT02873936|144508834|SUPERIORITY||Least Squares Mean Difference|-4.0|STANDARD_ERROR_OF_MEAN|0.9|<|0.001|TWO_SIDED|95.0|-5.0|-2.0||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-2.0|-5.0|<0.001
72490624|NCT02873936|144508834|SUPERIORITY||Least Squares Mean Difference|-2.0|STANDARD_ERROR_OF_MEAN|0.9||0.039|TWO_SIDED|95.0|-4.0|0.0||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.0|-4.0|0.039
72568823|NCT04972123|144668994|SUPERIORITY|Reporting for the 4 hour fatigue score only.||||||0.591||||||Measures of fatigue were compared between groups using the Wilcoxon rank-sum test.|Wilcoxon (Mann-Whitney)|Measures of fatigue were compared between groups using the Wilcoxon rank-sum test.||Secondary endpoint -- Measures of Fatigue for evaluable ITT population who had a primary event.||||0.591
72490625|NCT02873936|144508835|SUPERIORITY||Least Squares Mean Difference|-12.0|STANDARD_ERROR_OF_MEAN|2.7|<|0.001|TWO_SIDED|95.0|-17.0|-7.0||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-7.0|-17.0|<0.001
72490626|NCT02873936|144508835|SUPERIORITY||Least Squares Mean Difference|-11.0|STANDARD_ERROR_OF_MEAN|2.7|<|0.001|TWO_SIDED|95.0|-16.0|-5.0||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-5.0|-16.0|<0.001
72490627|NCT02873936|144508835|SUPERIORITY||Least Squares Mean Difference|-18.0|STANDARD_ERROR_OF_MEAN|3.0|<|0.001|TWO_SIDED|95.0|-24.0|-12.0||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-12.0|-24.0|<0.001
72490628|NCT02873936|144508835|SUPERIORITY||Least Squares Mean Difference|-13.0|STANDARD_ERROR_OF_MEAN|3.0|<|0.001|TWO_SIDED|95.0|-19.0|-7.0||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-7.0|-19.0|<0.001
72516867|NCT02528253|144564389|SUPERIORITY||Odds Ratio (OR)|0.74||||0.377|TWO_SIDED|95.0|0.38|1.44|||Regression, Logistic|||Week 4, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.44|0.38|0.3770
72516868|NCT02528253|144564389|SUPERIORITY||Odds Ratio (OR)|2.68||||0.0009|TWO_SIDED|95.0|1.49|4.79|||Regression, Logistic|||Week 4, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||4.79|1.49|0.0009
72516869|NCT02528253|144564389|SUPERIORITY||Odds Ratio (OR)|3.29|||<|0.0001|TWO_SIDED|95.0|1.87|5.78|||Regression, Logistic|||Week 4, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||5.78|1.87|<.0001
72516870|NCT02528253|144564389|SUPERIORITY||Odds Ratio (OR)|1.59||||0.0011|TWO_SIDED|95.0|1.2|2.1|||Regression, Logistic|||Week 8, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||2.10|1.20|0.0011
72516871|NCT02528253|144564389|SUPERIORITY||Odds Ratio (OR)|1.87|||<|0.0001|TWO_SIDED|95.0|1.41|2.47|||Regression, Logistic|||Week 8, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||2.47|1.41|<.0001
72516872|NCT02528253|144564389|SUPERIORITY||Odds Ratio (OR)|1.33||||0.0273|TWO_SIDED|95.0|1.03|1.72|||Regression, Logistic|||Week 8, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.72|1.03|0.0273
72404701|NCT03274986|144316843|OTHER||Difference in depth of focus|0.54|||||TWO_SIDED|||||Hypothesis testing was not pre-specified.|||Difference in depth of focus (DFT015 - SN60WF)|||||
72516873|NCT02528253|144564389|SUPERIORITY||Odds Ratio (OR)|1.19||||0.1736|TWO_SIDED|95.0|0.93|1.54|||Regression, Logistic|||Week 8, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.54|0.93|0.1736
72516874|NCT02528253|144564389|SUPERIORITY||Odds Ratio (OR)|1.4||||0.0092|TWO_SIDED|95.0|1.09|1.81|||Regression, Logistic|||Week 8, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.81|1.09|0.0092
72516875|NCT02528253|144564389|SUPERIORITY||Odds Ratio (OR)|1.63||||0.0015|TWO_SIDED|95.0|1.2|2.2|||Regression, Logistic|||Week 8, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||2.20|1.20|0.0015
72516876|NCT02528253|144564389|SUPERIORITY||Odds Ratio (OR)|1.95|||<|0.0001|TWO_SIDED|95.0|1.45|2.63|||Regression, Logistic|||Week 8, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||2.63|1.45|<.0001
72568824|NCT04972123|144668994|SUPERIORITY|Reporting for the 8 hour fatigue score only.||||||0.034||||||Measures of fatigue were compared between groups using the Wilcoxon rank-sum test.|Wilcoxon (Mann-Whitney)|Measures of fatigue were compared between groups using the Wilcoxon rank-sum test.||Secondary endpoint -- Measures of Fatigue for evaluable ITT population who had a primary event.||||0.034
72568825|NCT00895947|144669005|SUPERIORITY_OR_OTHER|||||||0.25||95.0||||Overall comparison of treatment groups for incidence of ILI|Chi-squared|||||||0.25
72568826|NCT00895947|144669005|SUPERIORITY_OR_OTHER|||||||0.01||95.0||||Comparision of ILI incidence in subjects age 50 and older at baseline.|Chi-squared|||||||0.01
72568827|NCT00895947|144669005|SUPERIORITY_OR_OTHER|||||||0.32||95.0||||Comparison of ILI in subjects age \< 50 at baseline|Chi-squared|||||||0.32
72568828|NCT00895947|144669005|SUPERIORITY_OR_OTHER|||||||0.01||95.0||||Comparison of ILI incidence in subjects vaccinated against seasonal influenza prior to enrollment.|Chi-squared|||||||0.01
72568829|NCT00895947|144669005|SUPERIORITY_OR_OTHER|||||||0.45||95.0||||Comparison of ILI incidence in subjects not vaccinated against seasonal influenza prior to enrollment|Chi-squared|||||||0.45
72568830|NCT00895947|144669005|SUPERIORITY_OR_OTHER|||||||0.03||95.0||||Comparison of ILI incidence in male subjects|Chi-squared|||||||0.03
72568831|NCT00895947|144669005|SUPERIORITY_OR_OTHER|||||||0.99||95.0||||Comparison of ILI incidence in female subjects|Chi-squared|||||||0.99
72568832|NCT00895947|144669006|SUPERIORITY_OR_OTHER|||||||0.16||95.0||||Proportion of subjects reporting any cold/flu symptoms during treatment|Chi-squared|||||||0.16
72568833|NCT00895947|144669006|SUPERIORITY_OR_OTHER|||||||0.03||95.0||||Proportion of subjects reporting moderate to severe feverishness|Chi-squared|||||||0.03
72568834|NCT00895947|144669006|SUPERIORITY_OR_OTHER|||||||0.04||95.0||||Proportion of subjects reporting moderate to severe head congestion|Chi-squared|||||||0.04
72568835|NCT00895947|144669006|SUPERIORITY_OR_OTHER|||||||0.07||95.0||||Proportion of subjects reporting moderate to severe sore throat|Chi-squared|||||||0.07
72568836|NCT00895947|144669007|SUPERIORITY_OR_OTHER|||||||0.39||95.0||||Proportion of subjects reporting one of more days that cold/flu symptoms impacted ability to think clearly|Chi-squared|||||||0.39
72568837|NCT00895947|144669007|SUPERIORITY_OR_OTHER|||||||0.15||95.0||||Proportion of subjects reporting one of more days that cold/flu symptoms impacted ability to sleep well|Chi-squared|||||||0.15
72568838|NCT00895947|144669007|SUPERIORITY_OR_OTHER|||||||0.66||95.0||||Proportion of subjects reporting one of more days that cold/flu symptoms impacted ability to breathe easily|Chi-squared|||||||0.66
72568839|NCT00895947|144669007|SUPERIORITY_OR_OTHER|||||||0.48||95.0||||Proportion of subjects reporting one of more days that cold/flu symptoms impacted ability to walk, climb stairs and exercise|Chi-squared|||||||0.48
72568840|NCT00895947|144669007|SUPERIORITY_OR_OTHER|||||||0.26||95.0||||Proportion of subjects reporting one of more days that cold/flu symptoms impacted ability to perform daily activities|Chi-squared|||||||0.26
72568841|NCT00895947|144669007|SUPERIORITY_OR_OTHER|||||||0.25||95.0||||Proportion of subjects reporting one of more days that cold/flu symptoms impacted ability to work outside the home|Chi-squared|||||||0.25
72568842|NCT00895947|144669007|SUPERIORITY_OR_OTHER|||||||0.2||95.0||||Proportion of subjects reporting one of more days that cold/flu symptoms impacted ability to work inside the home|Chi-squared|||||||0.20
72568843|NCT00895947|144669007|SUPERIORITY_OR_OTHER|||||||0.2||95.0||||Proportion of subjects reporting one of more days that cold/flu symptoms impacted ability to interact with others|Chi-squared|||||||0.20
72568844|NCT00895947|144669007|SUPERIORITY_OR_OTHER|||||||0.32||95.0||||Proportion of subjects reporting one of more days that cold/flu symptoms impacted ability to live personal life|Chi-squared|||||||0.32
72568845|NCT00895947|144669008|SUPERIORITY_OR_OTHER|||||||0.66||95.0||||Proportion of subjects in each group reporting one or more days they felt sick|Chi-squared|||||||0.66
72568846|NCT00895947|144669008|SUPERIORITY_OR_OTHER|||||||0.88||95.0||||Proportion of subjects in each group reporting one or more days they missed work|Chi-squared|||||||0.88
72516877|NCT02528253|144564389|SUPERIORITY||Odds Ratio (OR)|1.41||||0.0164|TWO_SIDED|95.0|1.06|1.86|||Regression, Logistic|||Week 8, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.86|1.06|0.0164
72516878|NCT02528253|144564389|SUPERIORITY||Odds Ratio (OR)|1.16||||0.2857|TWO_SIDED|95.0|0.89|1.51|||Regression, Logistic|||Week 8, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.51|0.89|0.2857
72568847|NCT00895947|144669008|SUPERIORITY_OR_OTHER|||||||1||95.0||||Proportion of subjects in each group reporting one or more days they visited the doctor|Chi-squared|||||||1.0
72568848|NCT00895947|144669008|SUPERIORITY_OR_OTHER|||||||0.54||95.0||||Proportion of subjects in each group reporting one or more days they visited the pharmacy|Chi-squared|||||||0.54
72568849|NCT00895947|144669008|SUPERIORITY_OR_OTHER|||||||0.24||95.0||||Proportion of subjects in each group reporting one or more days they took cold/flu medication|Chi-squared|||||||0.24
72568850|NCT00895947|144669008|SUPERIORITY_OR_OTHER|||||||0.89||95.0||||Proportion of subjects in each group reporting one or more days they skipped a planned activity|Chi-squared|||||||0.89
72568851|NCT00895947|144669009|SUPERIORITY_OR_OTHER|||||||0.61||95.0||||Proportion of subjects in each group with a confirmed viral respiratory infection|Chi-squared|||||||0.61
72404702|NCT03274986|144316847|SUPERIORITY||Least Squares Mean Difference|-0.156|STANDARD_ERROR_OF_MEAN|0.0206|<|0.001|TWO_SIDED|95.0|-0.197|-0.115||2-sided p-value reported. A hypothesis test was based on a two sample t-test, with a type I error rate of 0.025, 1-sided.|t-test, 2 sided||Least squares mean difference (DFT015 - SN60WF)|||-0.115|-0.197|<0.001
72404703|NCT03274986|144316848|OTHER||Difference in percentage|18.0|||||TWO_SIDED|95.0|9.65|27.37|||||95% CI for the difference (DFT015 - SN60WF) is estimated using Miettinen-Nurminen method (1985).|||27.37|9.65|
72404704|NCT00603746|144316852|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.275|||<|0.001||95.0|0.18|0.37|||ANCOVA|||||0.370|0.180|<0.001
72404705|NCT00603746|144316852|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.272|||<|0.001|TWO_SIDED|95.0|0.178|0.367|||ANCOVA|||||0.367|0.178|<0.001
72404706|NCT00603746|144316852|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.264|||<|0.001|TWO_SIDED|95.0|0.171|0.357|||ANCOVA|||||0.357|0.171|<0.001
72404707|NCT00603746|144316852|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.225|||<|0.001|TWO_SIDED|95.0|0.131|0.32|||ANCOVA|||||0.320|0.131|<0.001
72404708|NCT00603746|144316852|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.198|||<|0.001|TWO_SIDED|95.0|0.105|0.291|||ANCOVA|||||0.291|0.105|<0.001
72516879|NCT02528253|144564389|SUPERIORITY||Odds Ratio (OR)|1.38||||0.0149|TWO_SIDED|95.0|1.07|1.8|||Regression, Logistic|||Week 8, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.80|1.07|0.0149
72404709|NCT01524627|144316881|SUPERIORITY|||||||0.0004|||||||t-test, 2 sided|||||||0.0004
72516880|NCT02528253|144564389|SUPERIORITY||Odds Ratio (OR)|2.08||||0.0001|TWO_SIDED|95.0|1.43|3.02|||Regression, Logistic|||Week 8, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||3.02|1.43|0.0001
72516881|NCT02528253|144564389|SUPERIORITY||Odds Ratio (OR)|2.27|||<|0.0001|TWO_SIDED|95.0|1.57|3.28|||Regression, Logistic|||Week 8, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||3.28|1.57|<.0001
72516882|NCT02528253|144564389|SUPERIORITY||Odds Ratio (OR)|1.34||||0.118|TWO_SIDED|95.0|0.93|1.92|||Regression, Logistic|||Week 8, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.92|0.93|0.1180
72516883|NCT02528253|144564389|SUPERIORITY||Odds Ratio (OR)|1.56||||0.0062|TWO_SIDED|95.0|1.13|2.14|||Regression, Logistic|||Week 8, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||2.14|1.13|0.0062
72568852|NCT00895947|144669009|SUPERIORITY_OR_OTHER|||||||0.003||95.0||||Proportion of subjects in each group with a moderate/severe viral respiratory infection|Chi-squared|||||||0.003
72568853|NCT00895947|144669009|SUPERIORITY_OR_OTHER|||||||0.03||95.0||||Proportion of subjects in each group with a moderate/severe influenza infection|Chi-squared|||||||0.03
72568854|NCT00895947|144669009|SUPERIORITY_OR_OTHER|||||||0.03||95.0||||Proportion of subjects in each group with a moderate/severe viral respiratory infection other than influenza|Chi-squared|||||||0.03
72568855|NCT00895947|144669010|SUPERIORITY_OR_OTHER|||||||0.54||95.0||||Proportion of subjects meeting the definition of acute respiratory illness during treatment|Chi-squared|||||||0.54
72404710|NCT01524627|144316881|SUPERIORITY|||||||0.1|||||||t-test, 2 sided|||||||0.1
72404711|NCT00717769|144316883|SUPERIORITY|||||||0.519|||||||ANCOVA|||Change from Baseline to Day 8||||0.519
72404712|NCT00717769|144316883|SUPERIORITY|||||||0.032|||||||ANCOVA|||Change from Baseline to Day 15||||0.032
72516884|NCT02528253|144564389|SUPERIORITY||Odds Ratio (OR)|1.7||||0.0009|TWO_SIDED|95.0|1.24|2.32|||Regression, Logistic|||Week 8, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||2.32|1.24|0.0009
72516885|NCT02528253|144564389|SUPERIORITY||Odds Ratio (OR)|2.69||||0.0003|TWO_SIDED|95.0|1.56|4.61|||Regression, Logistic|||Week 8, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||4.61|1.56|0.0003
72516886|NCT02528253|144564389|SUPERIORITY||Odds Ratio (OR)|3.1|||<|0.0001|TWO_SIDED|95.0|1.82|5.28|||Regression, Logistic|||Week 8, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||5.28|1.82|<.0001
72516887|NCT02528253|144564389|SUPERIORITY||Odds Ratio (OR)|1.33||||0.312|TWO_SIDED|95.0|0.76|2.32|||Regression, Logistic|||Week 8, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||2.32|0.76|0.3120
72516888|NCT02528253|144564389|SUPERIORITY||Odds Ratio (OR)|2.02||||0.0019|TWO_SIDED|95.0|1.3|3.14|||Regression, Logistic|||Week 8, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||3.14|1.30|0.0019
72516889|NCT02528253|144564389|SUPERIORITY||Odds Ratio (OR)|2.33||||0.0001|TWO_SIDED|95.0|1.52|3.59|||Regression, Logistic|||Week 8, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||3.59|1.52|0.0001
72516890|NCT02528253|144564389|SUPERIORITY||Odds Ratio (OR)|1.47||||0.0064|TWO_SIDED|95.0|1.12|1.95|||Regression, Logistic|||Week 16, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.95|1.12|0.0064
72568856|NCT00895947|144669010|SUPERIORITY_OR_OTHER|||||||0.06||95.0||||Proportion of subjects meeting with moderate/severe acute respiratory illness during treatment|Chi-squared|||||||0.06
72404713|NCT00717769|144316883|SUPERIORITY|||||||0.008|||||||ANCOVA|||Change from Baseline to Day 22||||0.008
72404714|NCT00717769|144316883|SUPERIORITY|||||||0.006|||||||ANCOVA|||Change from Baseline to Day 29||||0.006
72404715|NCT00717769|144316885|SUPERIORITY|||||||0.533|||||||ANCOVA|||Change from Baseline to Day 8||||0.533
72404716|NCT00717769|144316885|SUPERIORITY|||||||0.009|||||||ANCOVA|||Change from Baseline to Day 15||||0.009
72404717|NCT00717769|144316885|SUPERIORITY|||||||0.002|||||||ANCOVA|||Change from Baseline to Day 22||||0.002
72404718|NCT00717769|144316885|SUPERIORITY|||||||0.003|||||||ANCOVA|||Change from Baseline to Day 29||||0.003
72404719|NCT02917031|144316969|SUPERIORITY||Mean Difference (Final Values)|-2.595||||0.252|TWO_SIDED|95.0|-7.04|1.85|||ANCOVA|||Change from baseline, saxagliptin versus placebo.||1.850|-7.040|0.252
72404720|NCT02917031|144316970|SUPERIORITY||Mean Difference (Final Values)|-1.631||||0.425|TWO_SIDED|95.0|-5.635|2.373|||ANCOVA|||Saxagliptin: Change from baseline||2.373|-5.635|0.425
72490629|NCT02873936|144508835|SUPERIORITY||Least Squares Mean Difference|-18.0|STANDARD_ERROR_OF_MEAN|3.4|<|0.001|TWO_SIDED|95.0|-25.0|-12.0||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-12.0|-25.0|<0.001
72490630|NCT02873936|144508835|SUPERIORITY||Least Squares Mean Difference|-13.0|STANDARD_ERROR_OF_MEAN|3.4|<|0.001|TWO_SIDED|95.0|-19.0|-6.0||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-6.0|-19.0|<0.001
72490631|NCT02873936|144508836|SUPERIORITY||Least Squares Mean Difference|-12.0|STANDARD_ERROR_OF_MEAN|2.6|<|0.001|TWO_SIDED|95.0|-17.0|-7.0||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|Mixed effects model for repeated measure|||Filgotinib 200 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-7.0|-17.0|<0.001
72490632|NCT02873936|144508836|SUPERIORITY||Least Squares Mean Difference|-10.0|STANDARD_ERROR_OF_MEAN|2.6|<|0.001|TWO_SIDED|95.0|-15.0|-5.0||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-5.0|-15.0|<0.001
72490633|NCT02873936|144508836|SUPERIORITY||Least Squares Mean Difference|-16.0|STANDARD_ERROR_OF_MEAN|2.8|<|0.001|TWO_SIDED|95.0|-22.0|-11.0||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-11.0|-22.0|<0.001
72490634|NCT02873936|144508836|SUPERIORITY||Least Squares Mean Difference|-13.0|STANDARD_ERROR_OF_MEAN|2.7|<|0.001|TWO_SIDED|95.0|-18.0|-7.0||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-7.0|-18.0|<0.001
72490635|NCT02873936|144508836|SUPERIORITY||Least Squares Mean Difference|-13.0|STANDARD_ERROR_OF_MEAN|2.7|<|0.001|TWO_SIDED|95.0|-18.0|-8.0||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-8.0|-18.0|<0.001
72490636|NCT02873936|144508836|SUPERIORITY||Least Squares Mean Difference|-5.0|STANDARD_ERROR_OF_MEAN|2.7||0.052|TWO_SIDED|95.0|-11.0|0.0||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||0.0|-11.0|0.052
72490637|NCT02873936|144508837|SUPERIORITY||Least Squares Mean Difference|-16.0|STANDARD_ERROR_OF_MEAN|2.7|<|0.001|TWO_SIDED|95.0|-21.0|-10.0||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-10.0|-21.0|<0.001
72490638|NCT02873936|144508837|SUPERIORITY||Least Squares Mean Difference|-14.0|STANDARD_ERROR_OF_MEAN|2.7|<|0.001|TWO_SIDED|95.0|-19.0|-8.0||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-8.0|-19.0|<0.001
72516891|NCT02528253|144564389|SUPERIORITY||Odds Ratio (OR)|1.74||||0.0001|TWO_SIDED|95.0|1.32|2.31|||Regression, Logistic|||Week 16, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||2.31|1.32|0.0001
72404721|NCT02917031|144316971|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.925|TWO_SIDED|95.0|-1.996|2.197|||ANCOVA|||"Saxagliptin vs Placebo:~Change from baseline"||2.197|-1.996|0.925
72516892|NCT02528253|144564389|SUPERIORITY||Odds Ratio (OR)|1.15||||0.2757|TWO_SIDED|95.0|0.89|1.48|||Regression, Logistic|||Week 16, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.48|0.89|0.2757
72516893|NCT02528253|144564389|SUPERIORITY||Odds Ratio (OR)|1.28||||0.0575|TWO_SIDED|95.0|0.99|1.65|||Regression, Logistic|||Week 16, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.65|0.99|0.0575
72404722|NCT02917031|144316972|SUPERIORITY||Mean Difference (Final Values)|-3.605||||0.105|TWO_SIDED|95.0|-7.97|0.76|||ANCOVA|||Saxagliptin vs placebo: Change from baseline||0.760|-7.970|0.105
72516894|NCT02528253|144564389|SUPERIORITY||Odds Ratio (OR)|1.52||||0.0015|TWO_SIDED|95.0|1.17|1.96|||Regression, Logistic|||Week 16, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.96|1.17|0.0015
72516895|NCT02528253|144564389|SUPERIORITY||Odds Ratio (OR)|1.63||||0.0007|TWO_SIDED|95.0|1.23|2.16|||Regression, Logistic|||Week 16, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||2.16|1.23|0.0007
72516896|NCT02528253|144564389|SUPERIORITY||Odds Ratio (OR)|1.74||||0.0001|TWO_SIDED|95.0|1.31|2.31|||Regression, Logistic|||Week 16, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||2.31|1.31|0.0001
72516897|NCT02528253|144564389|SUPERIORITY||Odds Ratio (OR)|1.38||||0.0124|TWO_SIDED|95.0|1.07|1.79|||Regression, Logistic|||Week 16, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.79|1.07|0.0124
72516898|NCT02528253|144564389|SUPERIORITY||Odds Ratio (OR)|1.48||||0.0025|TWO_SIDED|95.0|1.15|1.91|||Regression, Logistic|||Week 16, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.91|1.15|0.0025
72516899|NCT02528253|144564389|SUPERIORITY||Odds Ratio (OR)|1.82||||0.0002|TWO_SIDED|95.0|1.33|2.51|||Regression, Logistic|||Week 16, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||2.51|1.33|0.0002
72516900|NCT02528253|144564389|SUPERIORITY||Odds Ratio (OR)|2.03|||<|0.0001|TWO_SIDED|95.0|1.48|2.79|||Regression, Logistic|||Week 16, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||2.79|1.48|<.0001
72516901|NCT02528253|144564389|SUPERIORITY||Odds Ratio (OR)|1.09||||0.5701|TWO_SIDED|95.0|0.8|1.49|||Regression, Logistic|||Week 16, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.49|0.80|0.5701
72516902|NCT02528253|144564389|SUPERIORITY||Odds Ratio (OR)|1.67||||0.0004|TWO_SIDED|95.0|1.26|2.22|||Regression, Logistic|||Week 16, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||2.22|1.26|0.0004
72404723|NCT02917031|144316973|SUPERIORITY||Ratio for relative change|0.971||||0.796|TWO_SIDED|95.0|0.777|1.214|||ANCOVA|||Saxagliptin vs placebo: Change from baseline||1.214|0.777|0.796
72516903|NCT02528253|144564389|SUPERIORITY||Odds Ratio (OR)|1.86|||<|0.0001|TWO_SIDED|95.0|1.4|2.46|||Regression, Logistic|||Week 16, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||2.46|1.40|<.0001
72516904|NCT02528253|144564389|SUPERIORITY||Odds Ratio (OR)|2.07||||0.0008|TWO_SIDED|95.0|1.35|3.17|||Regression, Logistic|||Week 16, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||3.17|1.35|0.0008
72516905|NCT02528253|144564389|SUPERIORITY||Odds Ratio (OR)|1.84||||0.0059|TWO_SIDED|95.0|1.19|2.83|||Regression, Logistic|||Week 16, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||2.83|1.19|0.0059
72516906|NCT02528253|144564389|SUPERIORITY||Odds Ratio (OR)|0.94||||0.7741|TWO_SIDED|95.0|0.6|1.46|||Regression, Logistic|||Week 16, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.46|0.60|0.7741
72516907|NCT02528253|144564389|SUPERIORITY||Odds Ratio (OR)|2.21|||<|0.0001|TWO_SIDED|95.0|1.5|3.25|||Regression, Logistic|||Week 16, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||3.25|1.50|<.0001
72516908|NCT02528253|144564389|SUPERIORITY||Odds Ratio (OR)|1.96||||0.0008|TWO_SIDED|95.0|1.32|2.9|||Regression, Logistic|||Week 16, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||2.90|1.32|0.0008
72516909|NCT02528253|144564389|SUPERIORITY||Odds Ratio (OR)|1.25||||0.089|TWO_SIDED|95.0|0.97|1.6|||Regression, Logistic|||Week 24, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.60|0.97|0.0890
72516910|NCT02528253|144564389|SUPERIORITY||Odds Ratio (OR)|1.42||||0.0067|TWO_SIDED|95.0|1.1|1.83|||Regression, Logistic|||Week 24, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.83|1.10|0.0067
72568857|NCT00895947|144669010|SUPERIORITY_OR_OTHER|||||||0.03||95.0||||Proportion of subjects with moderate/severe febrile acute respiratory illness during treatment|Chi-squared|||||||0.03
72568858|NCT00895947|144669010|SUPERIORITY_OR_OTHER|||||||0.6||95.0||||Proportion of subjects with moderate/severe afebrile acute respiratory illness during treatment|Chi-squared|||||||0.60
72404724|NCT01696435|144316978|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.62|TWO_SIDED|95.0|0.87|1.09||P-value was not adjusted for multiple comparisons. A priori, two-sided tests with an alpha level of 0.025 were used to account for the 2 co-primary outcomes (depression event and mood scores).|Regression, Cox||Active treatment vs. Placebo comparison|||1.09|.87|0.62
72516911|NCT02528253|144564389|SUPERIORITY||Odds Ratio (OR)|1.43||||0.0072|TWO_SIDED|95.0|1.1|1.85|||Regression, Logistic|||Week 24, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.85|1.10|0.0072
72516912|NCT02528253|144564389|SUPERIORITY||Odds Ratio (OR)|1.59||||0.0004|TWO_SIDED|95.0|1.23|2.06|||Regression, Logistic|||Week 24, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||2.06|1.23|0.0004
72516913|NCT02528253|144564389|SUPERIORITY||Odds Ratio (OR)|1.61||||0.0013|TWO_SIDED|95.0|1.2|2.15|||Regression, Logistic|||Week 24, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||2.15|1.20|0.0013
72516914|NCT02528253|144564389|SUPERIORITY||Odds Ratio (OR)|1.79|||<|0.0001|TWO_SIDED|95.0|1.34|2.39|||Regression, Logistic|||Week 24, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||2.39|1.34|<.0001
72568859|NCT05472662|144669011|EQUIVALENCE|Equivalence was demonstrated if the 95% CI of the adjusted mean difference in relative change from baseline in FEV1 between HFA-152a and HFA-134a was within the equivalence limits \[-10% ; +10%\].|Adjusted mean difference|1.86||||0.113|TWO_SIDED|95.0|-0.48|4.2|||ANCOVA|||"Statistical analysis performed on the data at 15 min post-dose timepoint.~Statistical analysis was performed by means of Analysis of Covariance (ANCOVA) model including treatment group, subject, and period as fixed effects and FEV1 baseline as covariate."||4.20|-0.48|0.113
72516915|NCT02528253|144564389|SUPERIORITY||Odds Ratio (OR)|2.23|||<|0.0001|TWO_SIDED|95.0|1.51|3.3|||Regression, Logistic|||Week 24, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||3.30|1.51|<.0001
72516916|NCT02528253|144564389|SUPERIORITY||Odds Ratio (OR)|2.53|||<|0.0001|TWO_SIDED|95.0|1.72|3.71|||Regression, Logistic|||Week 24, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||3.71|1.72|<.0001
72516917|NCT02528253|144564389|SUPERIORITY||Odds Ratio (OR)|1.26||||0.0732|TWO_SIDED|95.0|0.98|1.62|||Regression, Logistic|||Week 32, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.62|0.98|0.0732
72516918|NCT02528253|144564389|SUPERIORITY||Odds Ratio (OR)|1.3||||0.0399|TWO_SIDED|95.0|1.01|1.68|||Regression, Logistic|||Week 32, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.68|1.01|0.0399
72516919|NCT02528253|144564389|SUPERIORITY||Odds Ratio (OR)|1.29||||0.0536|TWO_SIDED|95.0|1.0|1.67|||Regression, Logistic|||Week 32, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.67|1.00|0.0536
72516920|NCT02528253|144564389|SUPERIORITY||Odds Ratio (OR)|1.45||||0.0043|TWO_SIDED|95.0|1.12|1.88|||Regression, Logistic|||Week 32, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.88|1.12|0.0043
72516921|NCT02528253|144564389|SUPERIORITY||Odds Ratio (OR)|1.43||||0.0143|TWO_SIDED|95.0|1.07|1.91|||Regression, Logistic|||Week 32, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.91|1.07|0.0143
72516922|NCT02528253|144564389|SUPERIORITY||Odds Ratio (OR)|1.63||||0.0007|TWO_SIDED|95.0|1.23|2.16|||Regression, Logistic|||Week 32, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||2.16|1.23|0.0007
72568860|NCT05472662|144669012|EQUIVALENCE|Equivalence was demonstrated if the 95% CI of the adjusted mean difference in relative change from baseline in FEV1 between HFA-152a and HFA-134a was within the equivalence limits \[-10% ; +10%\].|Adjusted mean difference|0.58||||0.483|TWO_SIDED|95.0|-1.1|2.25|||ANCOVA|||"Statistical analysis performed on the data at 5 min post-dose timepoint.~Statistical analysis was performed by means of Analysis of Covariance (ANCOVA) model including treatment group, subject, and period as fixed effects and FEV1 baseline as covariate."||2.25|-1.10|0.483
72516923|NCT02528253|144564389|SUPERIORITY||Odds Ratio (OR)|1.67||||0.005|TWO_SIDED|95.0|1.17|2.38|||Regression, Logistic|||Week 32, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||2.38|1.17|0.0050
72516924|NCT02528253|144564389|SUPERIORITY||Odds Ratio (OR)|1.68||||0.0043|TWO_SIDED|95.0|1.18|2.4|||Regression, Logistic|||Week 32, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||2.40|1.18|0.0043
72516925|NCT02528253|144564389|SUPERIORITY||Odds Ratio (OR)|1.15||||0.2777|TWO_SIDED|95.0|0.89|1.48|||Regression, Logistic|||Week 40, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.48|0.89|0.2777
72516926|NCT02528253|144564389|SUPERIORITY||Odds Ratio (OR)|1.32||||0.0326|TWO_SIDED|95.0|1.02|1.7|||Regression, Logistic|||Week 40, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.70|1.02|0.0326
72516927|NCT02528253|144564389|SUPERIORITY||Odds Ratio (OR)|1.19||||0.1823|TWO_SIDED|95.0|0.92|1.55|||Regression, Logistic|||Week 40, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.55|0.92|0.1823
72516928|NCT02528253|144564389|SUPERIORITY||Odds Ratio (OR)|1.32||||0.035|TWO_SIDED|95.0|1.02|1.71|||Regression, Logistic|||Week 40, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.71|1.02|0.0350
72516929|NCT02528253|144564389|SUPERIORITY||Odds Ratio (OR)|1.42||||0.0164|TWO_SIDED|95.0|1.07|1.88|||Regression, Logistic|||Week 40, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.88|1.07|0.0164
72516930|NCT02528253|144564389|SUPERIORITY||Odds Ratio (OR)|1.38||||0.0257|TWO_SIDED|95.0|1.04|1.84|||Regression, Logistic|||Week 40, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.84|1.04|0.0257
72516931|NCT02528253|144564389|SUPERIORITY||Odds Ratio (OR)|1.64||||0.007|TWO_SIDED|95.0|1.14|2.35|||Regression, Logistic|||Week 40, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||2.35|1.14|0.0070
72624577|NCT03863574|144778774|OTHER|Proof-of-concept||||||0.7211|||||||t-test, 2 sided|||Outcome Variable: Triglyceride||||0.7211
72516932|NCT02528253|144564389|SUPERIORITY||Odds Ratio (OR)|1.62||||0.0085|TWO_SIDED|95.0|1.13|2.32|||Regression, Logistic|||Week 40, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||2.32|1.13|0.0085
72516933|NCT02528253|144564389|SUPERIORITY||Odds Ratio (OR)|1.09||||0.4925|TWO_SIDED|95.0|0.85|1.41|||Regression, Logistic|||Week 48, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.41|0.85|0.4925
72516934|NCT02528253|144564389|SUPERIORITY||Odds Ratio (OR)|1.2||||0.1534|TWO_SIDED|95.0|0.93|1.55|||Regression, Logistic|||Week 48, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.55|0.93|0.1534
72404725|NCT01696435|144316978|SUPERIORITY||Hazard Ratio (HR)|1.13||||0.03|TWO_SIDED|95.0|1.01|1.26||P-value was not adjusted for multiple comparisons. A priori, two-sided tests with an alpha level of 0.025 were used to account for the 2 co-primary outcomes (depression event and mood scores).|Regression, Cox||Active treatment vs. Placebo comparison|||1.26|1.01|0.03
72404726|NCT01696435|144316979|SUPERIORITY||Mean Difference (Net)|0.01|||||TWO_SIDED|95.0|-0.04|0.05|||Mixed Models Analysis|||Test of whether the mean difference in change comparing the treatment groups is different than zero. See full SAP for all details.||0.05|-0.04|
72404727|NCT01696435|144316979|SUPERIORITY||Mean Difference (Net)|0.03|||||TWO_SIDED|95.0|-0.01|0.07|||Mixed Models Analysis|||Test of whether the mean difference in change comparing the treatment groups is different than zero. See full SAP for all details.||0.07|-0.01|
72404728|NCT01696435|144316980|SUPERIORITY||Hazard Ratio (HR)|0.99||||0.88|TWO_SIDED|95.0|0.87|1.13||P-value not adjusted for multiple comparisons. This outcome was not a pre-specified primary outcome and results are to be interpreted with caution.|Regression, Cox||Active treatment vs. Placebo comparison|||1.13|0.87|0.88
72404729|NCT01696435|144316980|SUPERIORITY||Hazard Ratio (HR)|1.17||||0.02|TWO_SIDED|95.0|1.03|1.33||P-value not adjusted for multiple comparisons. This outcome was not a pre-specified primary outcome and results are to be interpreted with caution.|Regression, Cox||Active treatment vs. Placebo comparison|||1.33|1.03|0.02
72516935|NCT02528253|144564389|SUPERIORITY||Odds Ratio (OR)|1.23||||0.1202|TWO_SIDED|95.0|0.95|1.6|||Regression, Logistic|||Week 48, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.60|0.95|0.1202
72516936|NCT02528253|144564389|SUPERIORITY||Odds Ratio (OR)|1.23||||0.1222|TWO_SIDED|95.0|0.95|1.6|||Regression, Logistic|||Week 48, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.60|0.95|0.1222
72568861|NCT05472662|144669012|EQUIVALENCE|Equivalence was demonstrated if the 95% CI of the adjusted mean difference in relative change from baseline in FEV1 between HFA-152a and HFA-134a was within the equivalence limits \[-10% ; +10%\].|Adjusted mean difference|0.23||||0.782|TWO_SIDED|95.0|-1.45|1.9|||ANCOVA|||"Statistical analysis performed on the data at 30 min post-dose timepoint.~Statistical analysis was performed by means of Analysis of Covariance (ANCOVA) model including treatment group, subject, and period as fixed effects and FEV1 baseline as covariate."||1.90|-1.45|0.782
72404730|NCT01696435|144316981|SUPERIORITY||Hazard Ratio (HR)|0.95||||0.67|TWO_SIDED|95.0|0.76|1.19|||Regression, Cox||Active treatment vs. Placebo comparison|P-value not adjusted for multiple comparisons. This outcome was not a pre-specified primary outcome and results are to be interpreted with caution.||1.19|0.76|0.67
72404731|NCT01696435|144316981|SUPERIORITY||Hazard Ratio (HR)|1.02||||0.88|TWO_SIDED|95.0|0.82|1.27|||Regression, Cox||Active treatment vs. Placebo comparison|P-value not adjusted for multiple comparisons. This outcome was not a pre-specified primary outcome and results are to be interpreted with caution.||1.27|0.82|0.88
72404732|NCT01852292|144316996|OTHER|Double Criteria for PFS|Cox Proportional Hazard|0.646|||||TWO_SIDED|95.0|0.44|0.94||||||||0.94|0.44|
72516937|NCT02528253|144564389|SUPERIORITY||Odds Ratio (OR)|1.42||||0.0179|TWO_SIDED|95.0|1.06|1.9|||Regression, Logistic|||Week 48, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.90|1.06|0.0179
72624578|NCT03863574|144778774|OTHER|Proof-of-concept||||||0.652|||||||t-test, 2 sided|||Outcome Variables: Total Cholesterol||||0.6520
72404733|NCT01852292|144316997|OTHER|Double criteria for OS|Cox Proportional Hazard|0.72|||||TWO_SIDED|95.0|0.49|1.04||||||||1.04|0.49|
72404734|NCT02586012|144317022|SUPERIORITY||||||<|0.05|||||||Mixed Models Analysis|||||||<0.05
72404735|NCT02586012|144317023|SUPERIORITY||||||<|0.05|||||||Mixed Models Analysis|||||||<0.05
72404736|NCT02586012|144317024|SUPERIORITY||||||<|0.05|||||||Mixed Models Analysis|||||||<0.05
72404737|NCT02342704|144317026|SUPERIORITY_OR_OTHER|||||||0.126|||||||Wilcoxon rank-sum test|p-value is based on Wilcoxon rank-sum test between the 2 treatment groups||Week 4||||0.1260
72404738|NCT02342704|144317026|SUPERIORITY_OR_OTHER|||||||0.3525|||||||negative binomial regression|p-value is based on negative binomial regression model, adjusted for baseline GD lesion count||Week 4||||0.3525
72404739|NCT02342704|144317026|SUPERIORITY_OR_OTHER|||||||0.0127|||||||Wilcoxon rank-sum test|p-value is based on Wilcoxon rank-sum test between the 2 treatment groups||Week 12||||0.0127
72404740|NCT02342704|144317026|SUPERIORITY_OR_OTHER|||||||0.0299|||||||negative binomial regression|p-value is based on negative binomial regression model, adjusted for baseline GD lesion count||Week 12||||0.0299
72404741|NCT02342704|144317026|SUPERIORITY_OR_OTHER|||||||0.0123|||||||Wilcoxon rank-sum test|p-value is based on Wilcoxon rank-sum test between the 2 treatment groups||Week 24||||0.0123
72404742|NCT02342704|144317026|SUPERIORITY_OR_OTHER|||||||0.0076|||||||negative binomial regression|p-value is based on negative binomial regression model, adjusted for baseline GD lesion count||Week 24||||0.0076
72404743|NCT02342704|144317027|SUPERIORITY_OR_OTHER|||||||0.5318|||||||Wilcoxon rank-sum test|p-value is based on Wilcoxon rank-sum test between the 2 treatment groups||T1 Lesion Volume Change||||0.5318
72404744|NCT02342704|144317027|SUPERIORITY_OR_OTHER|||||||0.0528|||||||Wilcoxon rank-sum test|p-value is based on Wilcoxon rank-sum test between the 2 treatment groups||T2 Lesion Volume Change||||0.0528
72404745|NCT02342704|144317029|SUPERIORITY_OR_OTHER|||||||0.2632|||||||Wilcoxon rank-sum test|p-value is based on Wilcoxon rank-sum test between the 2 treatment groups||||||0.2632
72404746|NCT02347527|144317036|SUPERIORITY|||||||0.038|||||||ANOVA|||||||0.038
72404747|NCT02347527|144317036|SUPERIORITY|||||||0.036|||||||ANOVA|||||||0.036
72404748|NCT02347527|144317037|SUPERIORITY|||||||0.01|||||||t-test, 2 sided|||||||0.010
72404749|NCT02347527|144317038|OTHER|||||||0.04|||||||Pearson's correlation|||Relationship between change in high-calorie food ratings and subsequent food intake (kcals).||||0.040
72404750|NCT02347527|144317038|OTHER|||||||0.92|||||||Pearson's correlation|||Relationship between change in high-calorie food ratings and subsequent food intake (kcals).||||0.92
72404751|NCT01632891|144317043|SUPERIORITY|Test used alpha level of 0.05||||||1|||||||Fisher Exact|||Compare proportions of Pf SCP clearance between treatment arms||||1.00
72516938|NCT02528253|144564389|SUPERIORITY||Odds Ratio (OR)|1.49||||0.0065|TWO_SIDED|95.0|1.12|1.99|||Regression, Logistic|||Week 48, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.99|1.12|0.0065
72568862|NCT05472662|144669012|EQUIVALENCE|Equivalence was demonstrated if the 95% CI of the adjusted mean difference in relative change from baseline in FEV1 between HFA-152a and HFA-134a was within the equivalence limits \[-10% ; +10%\].|Adjusted mean difference|-0.4||||0.599|TWO_SIDED|95.0|-1.97|1.16|||ANCOVA|||"Statistical analysis performed on the data at 1 h post-dose timepoint.~Statistical analysis was performed by means of Analysis of Covariance (ANCOVA) model including treatment group, subject, and period as fixed effects and FEV1 baseline as covariate."||1.16|-1.97|0.599
72568863|NCT05472662|144669012|EQUIVALENCE|Equivalence was demonstrated if the 95% CI of the adjusted mean difference in relative change from baseline in FEV1 between HFA-152a and HFA-134a was within the equivalence limits \[-10% ; +10%\].|Adjusted mean difference|-0.13||||0.815|TWO_SIDED|95.0|-1.24|0.99|||ANCOVA|||"Statistical analysis performed on the data at 1.5 h post-dose timepoint.~Statistical analysis was performed by means of Analysis of Covariance (ANCOVA) model including treatment group, subject, and period as fixed effects and FEV1 baseline as covariate."||0.99|-1.24|0.815
72568864|NCT05472662|144669012|EQUIVALENCE|Equivalence was demonstrated if the 95% CI of the adjusted mean difference in relative change from baseline in FEV1 between HFA-152a and HFA-134a was within the equivalence limits \[-10% ; +10%\].|Adjusted mean difference|-0.69||||0.294|TWO_SIDED|95.0|-2.01|0.64|||ANCOVA|||"Statistical analysis performed on the data at 3 h post-dose timepoint.~Statistical analysis was performed by means of Analysis of Covariance (ANCOVA) model including treatment group, subject, and period as fixed effects and FEV1 baseline as covariate."||0.64|-2.01|0.294
72568865|NCT05472662|144669013|OTHER||Adjusted mean difference|0.015||||0.519|TWO_SIDED|95.0|-0.032|0.061|||ANCOVA|||"Statistical analysis performed on the data at 5 min post-dose timepoint.~Statistical analysis was performed by means of Analysis of Covariance (ANCOVA) model including treatment group, subject and period as fixed effects and FEV1 baseline as covariate."|Assess differences between treatment groups.|0.061|-0.032|0.519
72568866|NCT05472662|144669013|OTHER||Adjusted mean difference|0.061||||0.085|TWO_SIDED|95.0|-0.009|0.13|||ANCOVA|||"Statistical analysis performed on the data at 15 min post-dose timepoint.~Statistical analysis was performed by means of Analysis of Covariance (ANCOVA) model including treatment group, subject and period as fixed effects and FEV1 baseline as covariate."|Assess differences between treatment groups.|0.130|-0.009|0.085
72568867|NCT05472662|144669013|OTHER||Adjusted mean difference|0.004||||0.858|TWO_SIDED|95.0|-0.045|0.054|||ANCOVA|||"Statistical analysis performed on the data at 30 min post-dose timepoint.~Statistical analysis was performed by means of Analysis of Covariance (ANCOVA) model including treatment group, subject and period as fixed effects and FEV1 baseline as covariate."|Assess differences between treatment groups.|0.054|-0.045|0.858
72568868|NCT05472662|144669013|OTHER||Adjusted mean difference|-0.011||||0.632|TWO_SIDED|95.0|-0.058|0.036|||ANCOVA|||"Statistical analysis performed on the data at 1 h post-dose timepoint.~Statistical analysis was performed by means of Analysis of Covariance (ANCOVA) model including treatment group, subject and period as fixed effects and FEV1 baseline as covariate."|Assess differences between treatment groups.|0.036|-0.058|0.632
72404752|NCT04206293|144317068|SUPERIORITY||Least Squares (LS) Mean Difference|1.7|STANDARD_ERROR_OF_MEAN|0.9||0.0736|TWO_SIDED|95.0|-0.2|3.6|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||Change from Baseline to Day 28||3.6|-0.2|0.0736
72568869|NCT05472662|144669013|OTHER||Adjusted mean difference|-0.003||||0.846|TWO_SIDED|95.0|-0.038|0.031|||ANCOVA|||"Statistical analysis performed on the data at 1.5 h post-dose timepoint.~Statistical analysis was performed by means of Analysis of Covariance (ANCOVA) model including treatment group, subject and period as fixed effects and FEV1 baseline as covariate."|Assess differences between treatment groups.|0.031|-0.038|0.846
72568870|NCT05472662|144669013|OTHER||Adjusted mean difference|-0.024||||0.282|TWO_SIDED|95.0|-0.068|0.021|||ANCOVA|||"Statistical analysis performed on the data at 3 h post-dose timepoint.~Statistical analysis was performed by means of Analysis of Covariance (ANCOVA) model including treatment group, subject and period as fixed effects and FEV1 baseline as covariate."|Assess differences between treatment groups.|0.021|-0.068|0.282
72568871|NCT04620135|144669025|SUPERIORITY||The least squares (LS) mean difference|-1.74|STANDARD_ERROR_OF_MEAN|0.221|<|1e-05|TWO_SIDED|95.0|-2.17|-1.31||Analyzed as ANCOVA with mean diurnal IOP at Week 4 as the response, baseline mean diurnal IOP as a covariate, and treatment as a main effect, using the ITT population with MCMC and regression-based multiple imputation to impute missing data.|ANCOVA||||The primary analysis of the primary endpoint employed an analysis of covariance (ANCOVA) with mean diurnal IOP at Week 4 as the response, baseline mean diurnal IOP as a covariate, and treatment as a main effect, using the ITT population with Markov Chain Monte Carlo (MCMC) and regression based multiple imputation (MI) techniques to impute missing data. The least squares (LS) mean difference (netarsudil - ripasudil) was presented with a 2-sided p-value and 95% confidence intervals (CIs). A success criterion for the superiority of netarsudil to ripasudil was defined as the 2-sided p value ≤ 0.05 for testing the difference (netarsudil QD - ripasudil BID) to 0 and the point estimate of the LS mean difference of \< 0.|-1.31|-2.17|<0.00001
72568872|NCT00311311|144669043|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.036||||0.0445|TWO_SIDED|95.0|0.001|0.07||P-value and 95% CI for least square (LS) mean difference were calculated from repeated measures ANCOVA mixed model with baseline value, treatment group, time, and treatment group by time interaction as fixed effects, and subjects as random effect.|ANCOVA||LS mean difference|12 months post-transplant||0.070|0.001|0.0445
72568873|NCT00311311|144669043|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.034||||0.0288|TWO_SIDED|95.0|0.004|0.064||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value, treatment group, time, and treatment group by time interaction as fixed effects, and subjects as random effect.|ANCOVA||LS mean difference|18 months post-transplant||0.064|0.004|0.0288
72568874|NCT00311311|144669043|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.032||||0.0269|TWO_SIDED|95.0|0.004|0.06||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value, treatment group, time, and treatment group by time interaction as fixed effects, and subjects as random effect.|ANCOVA||LS mean difference|24 months post-transplant||0.060|0.004|0.0269
72404753|NCT04206293|144317068|SUPERIORITY||LS Mean Difference|0.7|STANDARD_ERROR_OF_MEAN|1.0||0.5259|TWO_SIDED|95.0|-1.5|2.8|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||Change from Baseline to Day 84||2.8|-1.5|0.5259
72624579|NCT03863574|144778774|OTHER|Proof-of-concept||||||0.4302|||||||t-test, 2 sided|||Outcome Variable: Total Cholesterol||||0.4302
72490639|NCT02873936|144508837|SUPERIORITY||Least Squares Mean Difference|-17.0|STANDARD_ERROR_OF_MEAN|3.1|<|0.001|TWO_SIDED|95.0|-23.0|-11.0||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-11.0|-23.0|<0.001
72624580|NCT03863574|144778774|OTHER|Proof-of-concept||||||0.9432|||||||t-test, 2 sided|||Outcome Variable: High-density Lipoprotein||||0.9432
72404754|NCT04206293|144317069|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|1.2||0.8848|TWO_SIDED|95.0|-2.8|2.4|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||Change from Baseline to Day 28||2.4|-2.8|0.8848
72490640|NCT02873936|144508837|SUPERIORITY||Least Squares Mean Difference|-13.0|STANDARD_ERROR_OF_MEAN|3.1|<|0.001|TWO_SIDED|95.0|-19.0|-7.0||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-7.0|-19.0|<0.001
72490641|NCT02873936|144508837|SUPERIORITY||Least Squares Mean Difference|-16.0|STANDARD_ERROR_OF_MEAN|3.4|<|0.001|TWO_SIDED|95.0|-23.0|-10.0||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-10.0|-23.0|<0.001
72490642|NCT02873936|144508837|SUPERIORITY||Least Squares Mean Difference|-12.0|STANDARD_ERROR_OF_MEAN|3.4|<|0.001|TWO_SIDED|95.0|-19.0|-5.0||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-5.0|-19.0|<0.001
72490643|NCT02873936|144508838|SUPERIORITY||Least Squares Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.055|<|0.001|TWO_SIDED|95.0|-0.33|-0.11||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.11|-0.33|<0.001
72490644|NCT02873936|144508838|SUPERIORITY||Least Squares Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.055||0.006|TWO_SIDED|95.0|-0.26|-0.04||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.04|-0.26|0.006
72516939|NCT02528253|144564389|SUPERIORITY||Odds Ratio (OR)|1.53||||0.0223|TWO_SIDED|95.0|1.06|2.2|||Regression, Logistic|||Week 48, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||2.20|1.06|0.0223
72516940|NCT02528253|144564389|SUPERIORITY||Odds Ratio (OR)|1.68||||0.0045|TWO_SIDED|95.0|1.17|2.4|||Regression, Logistic|||Week 48, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||2.40|1.17|0.0045
72404755|NCT04206293|144317069|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.8||0.9505|TWO_SIDED|95.0|-1.8|1.7|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||Change from Baseline to Day 84||1.7|-1.8|0.9505
72490645|NCT02873936|144508838|SUPERIORITY||Least Squares Mean Difference|-0.36|STANDARD_ERROR_OF_MEAN|0.075|<|0.001|TWO_SIDED|95.0|-0.51|-0.21||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.21|-0.51|<0.001
72516941|NCT02528253|144564389|SUPERIORITY||Odds Ratio (OR)|0.99||||0.9385|TWO_SIDED|95.0|0.77|1.28|||Regression, Logistic|||Week 56, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.28|0.77|0.9385
72624581|NCT03863574|144778774|OTHER|Proof-of-concept||||||0.2133|||||||t-test, 2 sided|||Outcome Variable: High-density Lipoprotein||||0.2133
72624582|NCT03863574|144778774|OTHER|Proof-of-concept||||||0.2446|||||||t-test, 2 sided|||Outcome Variable: Low-density lipoprotein||||0.2446
72624583|NCT03863574|144778774|OTHER|Proof-of-concept||||||0.7075|||||||t-test, 2 sided|||Outcome Variable: Low-density lipoprotein||||0.7075
72624584|NCT03863574|144778774|OTHER|Proof-of-concept||||||0.2195|||||||t-test, 2 sided|||Outcome Variable: Very low-density lipoprotein||||0.2195
72624585|NCT03863574|144778774|OTHER|Proof-of-concept||||||0.7435|||||||t-test, 2 sided|||Outcome Variable: Very low-density lipoprotein||||0.7435
72624586|NCT03863574|144778774|OTHER|Proof-of-concept||||||0.5702|||||||t-test, 2 sided|||Outcome Variable: non-HDL Cholesterol||||0.5702
72624587|NCT03863574|144778774|OTHER|Proof-of-concept||||||0.6441|||||||t-test, 2 sided|||Outcome Variable: non-HDL Cholesterol||||0.6441
72624588|NCT03863574|144778774|OTHER|Proof-of-concept||||||0.8415|||||||t-test, 2 sided|||Outcome Variable: Apo lipoprotein A1||||0.8415
72624589|NCT03863574|144778774|OTHER|Proof-of-concept||||||0.0786|||||||t-test, 2 sided|||Outcome Variable: Apo lipoprotein A1||||0.0786
72568875|NCT00311311|144669043|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.028||||0.097|TWO_SIDED|95.0|-0.005|0.06||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value, treatment group, time, and treatment group by time interaction as fixed effects, and subjects as random effect.|ANCOVA||LS mean difference|36 months post-transplant||0.060|-0.005|0.0970
72568876|NCT00311311|144669046|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.74|||<|0.0001|TWO_SIDED|95.0|0.39|1.09||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|TC 12 Months Post-transplant||1.09|0.39|<.0001
72568877|NCT00311311|144669046|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.41||||0.0022|TWO_SIDED|95.0|0.15|0.67||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|LDL 12 Months Post-transplant||0.67|0.15|0.0022
72624590|NCT03863574|144778774|OTHER|Proof-of-concept||||||0.8878|||||||t-test, 2 sided|||Outcome Variable: Apo lipoprotein B||||0.8878
72568878|NCT00311311|144669046|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.08||||0.1612|TWO_SIDED|95.0|-0.03|0.19||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|HDL 12 Months Post-transplant||0.19|-0.03|0.1612
72568879|NCT00311311|144669046|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.56||||0.0005|TWO_SIDED|95.0|0.26|0.86||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|Tg 12 Months Post-transplant||0.86|0.26|0.0005
72624591|NCT03863574|144778774|OTHER|Proof-of-concept||||||0.3219|||||||t-test, 2 sided|||Outcome variable: Apo lipoprotein B||||0.3219
72624592|NCT03863574|144778774|OTHER|Proof-of-concept||||||0.6557|||||||t-test, 2 sided|||Outcome Variable: Small dense LDL||||0.6557
72624593|NCT03863574|144778774|OTHER|Proof-of-concept||||||0.0763|||||||t-test, 2 sided|||Outcome Variable: Small dense LDL||||0.0763
72568880|NCT00311311|144669046|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.66||||0.0006|TWO_SIDED|95.0|0.3|1.02||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|TC 18 Months Post-transplant||1.02|0.30|0.0006
72568881|NCT00311311|144669046|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.34||||0.0126|TWO_SIDED|95.0|0.08|0.61||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|LDL 18 Months Post-transplant||0.61|0.08|0.0126
72568882|NCT00311311|144669046|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.06||||0.238|TWO_SIDED|95.0|-0.04|0.17||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|HDL 18 Months Post-transplant||0.17|-0.04|0.2380
72624594|NCT03863574|144778776|OTHER|Proof-of-concept||||||0.6988|||||||t-test, 2 sided|||||||0.6988
72624595|NCT03863574|144778776|OTHER|Proof-of-concept||||||0.7413|||||||t-test, 2 sided|||||||0.7413
72624596|NCT03863574|144778777|OTHER|Proof-of-concept||||||0.22|||||||t-test, 2 sided|||||||0.2200
72624597|NCT03863574|144778777|OTHER|Proof-of-concept||||||0.5798|||||||t-test, 2 sided|||||||0.5798
72624598|NCT03863574|144778778|OTHER|Proof-of-concept||||||0.4981|||||||t-test, 2 sided|||||||0.4981
72624599|NCT03863574|144778778|OTHER|Proof-of-concept||||||0.8939|||||||t-test, 2 sided|||||||0.8939
72624600|NCT03863574|144778779|OTHER|Proof-of-concept||||||0.3605|||||||t-test, 2 sided|||||||0.3605
72624601|NCT03863574|144778779|OTHER|Proof-of-concept||||||0.8394|||||||t-test, 2 sided|||||||0.8394
72624602|NCT03863574|144778780|OTHER|Proof-of-concept||||||0.2665|||||||t-test, 2 sided|||||||0.2665
72624603|NCT03863574|144778780|OTHER|Proof-of-concept||||||0.9133|||||||t-test, 2 sided|||||||0.9133
72624604|NCT03863574|144778781|OTHER|Proof-of-concept||||||0.7267|||||||t-test, 2 sided|||||||0.7267
72624605|NCT03863574|144778781|OTHER|Proof-of-concept||||||0.9211|||||||t-test, 2 sided|||||||0.9211
72624606|NCT03863574|144778782|OTHER|Proof-of-concept||||||0.8683|||||||t-test, 2 sided|||||||0.8683
72624607|NCT03863574|144778782|OTHER|Proof-of-concept||||||0.7436|||||||t-test, 2 sided|||||||0.7436
72624608|NCT05081843|144778791|SUPERIORITY||Mean Difference (Final Values)|0.233||||0.05|TWO_SIDED|95.0|-0.056|0.522|||t-test, 2 sided|||||0.522|-0.056|0.05
72624609|NCT05081843|144778792|SUPERIORITY||Median Difference (Final Values)|0.534||||0.05|TWO_SIDED|95.0|0.078|0.99|||t-test, 2 sided|||||0.990|0.078|0.05
72624610|NCT05081843|144778793|SUPERIORITY||Mean Difference (Final Values)|0.326||||0.05|TWO_SIDED|95.0|-0.177|0.829|||t-test, 2 sided|||||0.829|-0.177|0.05
72624611|NCT05081843|144778794|SUPERIORITY||Mean Difference (Final Values)|0.756||||0.05|TWO_SIDED|95.0|0.208|1.31|||t-test, 2 sided|||||1.31|0.208|0.05
72624612|NCT02303821|144778801|OTHER||||||||||||||||||The objective of this endpoint was to compare the rate of CRi or better status against an external control arm selected from an observational study (Amgen 20180065). The rate of CRi or better status in the external control arm was 26.3% (95% CI: 15.1, 37.5) for B-Cell participants with treatment difference odds ratio of 2.082 (95% CI: 0.968, 4.477). For T-Cell participants the rate of CRi or better status was 18.6% (95% CI: 7.1, 30.0) with treatment difference odds ratio of 1.646 (95% CI: 0.639. 4.245).|||
72490646|NCT02873936|144508838|SUPERIORITY||Least Squares Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.075||0.003|TWO_SIDED|95.0|-0.37|-0.08||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.08|-0.37|0.003
72490647|NCT02873936|144508839|SUPERIORITY||Least Squares Mean Difference|-10.51|STANDARD_ERROR_OF_MEAN|1.578|<|0.001|TWO_SIDED|95.0|-13.61|-7.41||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-7.41|-13.61|<0.001
72490648|NCT02873936|144508839|SUPERIORITY||Least Squares Mean Difference|-8.92|STANDARD_ERROR_OF_MEAN|1.577|<|0.001|TWO_SIDED|95.0|-12.02|-5.82||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-5.82|-12.02|<0.001
72490649|NCT02873936|144508839|SUPERIORITY||Least Squares Mean Difference|-10.94|STANDARD_ERROR_OF_MEAN|1.652|<|0.001|TWO_SIDED|95.0|-14.19|-7.69||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-7.69|-14.19|<0.001
72490650|NCT02873936|144508839|SUPERIORITY||Least Squares Mean Difference|-8.98|STANDARD_ERROR_OF_MEAN|1.651|<|0.001|TWO_SIDED|95.0|-12.22|-5.73||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-5.73|-12.22|<0.001
72490651|NCT02873936|144508839|SUPERIORITY||Least Squares Mean Difference|-9.87|STANDARD_ERROR_OF_MEAN|1.964|<|0.001|TWO_SIDED|95.0|-13.73|-6.0||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-6.00|-13.73|<0.001
72490652|NCT02873936|144508839|SUPERIORITY||Least Squares Mean Difference|-6.89|STANDARD_ERROR_OF_MEAN|1.987|<|0.001|TWO_SIDED|95.0|-10.8|-2.98||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-2.98|-10.80|<0.001
72490653|NCT02873936|144508840|SUPERIORITY||Difference in Response Rates|20.1|||<|0.001|TWO_SIDED|95.0|8.1|32.1||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg vs Placebo at Week 4.||32.1|8.1|<0.001
72490654|NCT02873936|144508840|SUPERIORITY||Difference in Response Rates|14.5||||0.013|TWO_SIDED|95.0|2.4|26.5||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg vs Placebo at Week 4.||26.5|2.4|0.013
72490655|NCT02873936|144508840|SUPERIORITY||Difference in Response Rates|22.2|||<|0.001|TWO_SIDED|95.0|10.3|34.1||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg vs Placebo at Week 12.||34.1|10.3|<0.001
72568883|NCT00311311|144669046|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.58||||0.0003|TWO_SIDED|95.0|0.27|0.88||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|Tg 18 Months Post-transplant||0.88|0.27|0.0003
72490656|NCT02873936|144508840|SUPERIORITY||Difference in Response Rates|21.8|||<|0.001|TWO_SIDED|95.0|10.0|33.6||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg vs Placebo at Week 12.||33.6|10.0|<0.001
72490657|NCT02873936|144508840|SUPERIORITY||Difference in Response Rates|33.3|||<|0.001|TWO_SIDED|95.0|21.8|44.9||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg vs Placebo at Week 24.||44.9|21.8|<0.001
72490658|NCT02873936|144508840|SUPERIORITY||Difference in Response Rates|18.6||||0.001|TWO_SIDED|95.0|6.8|30.5||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg vs Placebo at Week 24.||30.5|6.8|0.001
72490659|NCT02873936|144508841|SUPERIORITY||Least Squares Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|0.13|<|0.001|TWO_SIDED|95.0|-1.1|-0.6||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.6|-1.1|<0.001
72490660|NCT02873936|144508841|SUPERIORITY||Least Squares Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.13|<|0.001|TWO_SIDED|95.0|-0.9|-0.4||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.4|-0.9|<0.001
72404756|NCT04206293|144317070|SUPERIORITY||LS Mean Difference|2.7|STANDARD_ERROR_OF_MEAN|0.6||0.0007|TWO_SIDED|95.0|1.4|4.0|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||Change from Baseline to Day 28||4.0|1.4|0.0007
72568884|NCT00311311|144669046|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.59||||0.0065|TWO_SIDED|95.0|0.17|1.0||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|TC 24 Months Post-transplant||1.00|0.17|0.0065
72568885|NCT00311311|144669046|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.28||||0.0845|TWO_SIDED|95.0|-0.04|0.6||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|LDL 24 Months Post-transplant||0.60|-0.04|0.0845
72568886|NCT00311311|144669046|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.05||||0.3742|TWO_SIDED|95.0|-0.06|0.16||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|HDL 24 Months Post-transplant||0.16|-0.06|0.3742
72568887|NCT00311311|144669046|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.59||||0.0006|TWO_SIDED|95.0|0.27|0.92||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|Tg 24 Months Post-transplant||0.92|0.27|0.0006
72568888|NCT00311311|144669046|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.44||||0.1488|TWO_SIDED|95.0|-0.16|1.03||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|TC 36 Months Post-transplant||1.03|-0.16|0.1488
72568889|NCT00311311|144669046|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.14||||0.546|TWO_SIDED|95.0|-0.33|0.62||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|LDL 36 Months Post-transplant||0.62|-0.33|0.5460
72568890|NCT00311311|144669046|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.02||||0.7511|TWO_SIDED|95.0|-0.12|0.16||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|HDL 36 Months Post-transplant||0.16|-0.12|0.7511
72624613|NCT02303821|144778802|OTHER||||||||||||||||||The objective of this endpoint was to compare EFS in study 20140106 with EFS in an external control arm selected from an observational study (Amgen 20180065). The median duration in months in the external control arm was 3.62 (95% CI: 1.55, 5.36) for B-cell participants, with a treatment difference hazard ration of 1.435 (95% CI: 0.976, 2.111). For T-Cell participants the median in months was 2.93 (95% CI: 0.95, 5.10) with a treatment difference hazard ratio of 1.404 (95% CI: 0.869, 2.270).|||
72624614|NCT02303821|144778803|OTHER||||||||||||||||||The objective of this endpoint was to compare the OS in study 20140106 with OS in an external control arm selected from an observational study (Amgen 20180065). The median OS in months for the B-Cell participants in the external control arm was 8.59 (95% CI: 5.26, 10.59) with a treatment difference hazard ratio of 1.245 (95% CI: 0.805, 1.927). For the T-Cell participants the median OS in months was 7.04 (95% CI: 7.04, NE) with a treatment difference hazard ratio of 1.040 (95% CI: 0.641, 1.688).|||
72490661|NCT02873936|144508841|SUPERIORITY||Least Squares Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|0.15|<|0.001|TWO_SIDED|95.0|-1.5|-0.9||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.9|-1.5|<0.001
72568891|NCT00311311|144669046|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.63||||0.0048|TWO_SIDED|95.0|0.2|1.06||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|Tg 36 Months Post-transplant||1.06|0.20|0.0048
72568892|NCT00311311|144669047|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.78||||0.1757|TWO_SIDED|95.0|-0.36|1.91||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|12 months post-transplant||1.91|-0.36|0.1757
72568893|NCT00311311|144669047|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.94||||0.0509|TWO_SIDED|95.0|0.0|1.89||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|24 months post-transplant||1.89|-0.00|0.0509
72624615|NCT02303821|144778804|OTHER||||||||||||||||||The DOR in study 20140106 was estimated relative to the DOR in an external control arm selected from an observational study (Amgen 20180065). The median DOR in months in the external control arm was 8.72 (95% CI: 5.07, 32.24) in B-Cell participants. For T-Cell participants the median DOR in months was 5.82 (95% CI: 1.22, 19.80).|||
72404757|NCT04206293|144317070|SUPERIORITY||LS Mean Difference|2.4|STANDARD_ERROR_OF_MEAN|0.7||0.0033|TWO_SIDED|95.0|0.9|3.9|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||Change from Baseline to Day 84||3.9|0.9|0.0033
72404758|NCT04206293|144317071|SUPERIORITY||LS Mean Difference|-0.095|STANDARD_ERROR_OF_MEAN|0.011|<|0.0001|TWO_SIDED|95.0|-0.119|-0.07|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||Uf: Change from Baseline to Day 28||-0.070|-0.119|<0.0001
72490662|NCT02873936|144508841|SUPERIORITY||Least Squares Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.15|<|0.001|TWO_SIDED|95.0|-1.3|-0.7||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.7|-1.3|<0.001
72568894|NCT00311311|144669047|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.11||||0.0683|TWO_SIDED|95.0|-0.09|2.31||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|36 months post-transplant||2.31|-0.09|0.0683
72568895|NCT00311311|144669048|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-37.47||||0.2741|TWO_SIDED|95.0|-105.79|30.85||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|12 months post-transplant||30.85|-105.79|0.2741
72568896|NCT00311311|144669048|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.97||||0.4865|TWO_SIDED|95.0|-77.48|37.53||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|24 months post-transplant||37.53|-77.48|0.4865
72404759|NCT04206293|144317071|SUPERIORITY||LS Mean Difference|-0.071|STANDARD_ERROR_OF_MEAN|0.011|<|0.0001|TWO_SIDED|95.0|-0.094|-0.048|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||Uf: Change from Baseline to Day 84||-0.048|-0.094|<0.0001
72404760|NCT04206293|144317071|SUPERIORITY||LS Mean Difference|-0.089|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|-0.116|-0.061|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||Ue: Change from Baseline to Day 28||-0.061|-0.116|<0.0001
72516942|NCT02528253|144564389|SUPERIORITY||Odds Ratio (OR)|1.23||||0.1093|TWO_SIDED|95.0|0.95|1.59|||Regression, Logistic|||Week 56, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.59|0.95|0.1093
72516943|NCT02528253|144564389|SUPERIORITY||Odds Ratio (OR)|1.21||||0.1631|TWO_SIDED|95.0|0.93|1.57|||Regression, Logistic|||Week 56, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.57|0.93|0.1631
72516944|NCT02528253|144564389|SUPERIORITY||Odds Ratio (OR)|1.34||||0.0285|TWO_SIDED|95.0|1.03|1.74|||Regression, Logistic|||Week 56, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.74|1.03|0.0285
72516945|NCT02528253|144564389|SUPERIORITY||Odds Ratio (OR)|1.36||||0.0389|TWO_SIDED|95.0|1.02|1.81|||Regression, Logistic|||Week 56, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.81|1.02|0.0389
72516946|NCT02528253|144564389|SUPERIORITY||Odds Ratio (OR)|1.39||||0.024|TWO_SIDED|95.0|1.04|1.86|||Regression, Logistic|||Week 56, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.86|1.04|0.0240
72516947|NCT02528253|144564389|SUPERIORITY||Odds Ratio (OR)|1.64||||0.0063|TWO_SIDED|95.0|1.15|2.34|||Regression, Logistic|||Week 56, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||2.34|1.15|0.0063
72516948|NCT02528253|144564389|SUPERIORITY||Odds Ratio (OR)|1.74||||0.0021|TWO_SIDED|95.0|1.22|2.47|||Regression, Logistic|||Week 56, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||2.47|1.22|0.0021
72516949|NCT02528253|144564391|SUPERIORITY||LS Mean Difference|-0.49|STANDARD_ERROR_OF_MEAN|0.13||0.0003|TWO_SIDED|95.0|-0.75|-0.22|||ANCOVA|||Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf worst pain, and baseline average LBPI as covariates, and study site as a random effect.||-0.22|-0.75|0.0003
72516950|NCT02528253|144564391|SUPERIORITY||LS Mean Difference|-0.59|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-0.85|-0.33|||ANCOVA|||Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf worst pain, and baseline average LBPI as covariates, and study site as a random effect.||-0.33|-0.85|<.0001
72516951|NCT02528253|144564391|SUPERIORITY||LS Mean Difference|-0.23|STANDARD_ERROR_OF_MEAN|0.12||0.0615|TWO_SIDED|95.0|-0.47|0.01|||ANCOVA|||Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf worst pain, and baseline average LBPI as covariates, and study site as a random effect.||0.01|-0.47|0.0615
72516952|NCT02528253|144564391|SUPERIORITY||LS Mean Difference|-0.26|STANDARD_ERROR_OF_MEAN|0.12||0.0356|TWO_SIDED|95.0|-0.5|-0.02|||ANCOVA|||Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf worst pain, and baseline average LBPI as covariates, and study site as a random effect.||-0.02|-0.50|0.0356
72568897|NCT00311311|144669048|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.48||||0.9339|TWO_SIDED|95.0|-62.54|57.59||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|36 months post-transplant||57.59|-62.54|0.9339
72568898|NCT00311311|144669049|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.003||||0.4892|TWO_SIDED|95.0|-0.005|0.011||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|12 months post-transplant||0.011|-0.005|0.4892
72516953|NCT02528253|144564391|SUPERIORITY||LS Mean Difference|-0.36|STANDARD_ERROR_OF_MEAN|0.12||0.0032|TWO_SIDED|95.0|-0.6|-0.12|||ANCOVA|||Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf worst pain, and baseline average LBPI as covariates, and study site as a random effect.||-0.12|-0.60|0.0032
72516954|NCT02528253|144564391|SUPERIORITY||LS Mean Difference|-0.57|STANDARD_ERROR_OF_MEAN|0.16||0.0003|TWO_SIDED|95.0|-0.88|-0.27|||ANCOVA|||Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf worst pain, and baseline average LBPI as covariates, and study site as a random effect.||-0.27|-0.88|0.0003
72516955|NCT02528253|144564391|SUPERIORITY||LS Mean Difference|-0.77|STANDARD_ERROR_OF_MEAN|0.16|<|0.0001|TWO_SIDED|95.0|-1.08|-0.46|||ANCOVA|||Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf worst pain, and baseline average LBPI as covariates, and study site as a random effect.||-0.46|-1.08|<.0001
72516956|NCT02528253|144564391|SUPERIORITY||LS Mean Difference|-0.25|STANDARD_ERROR_OF_MEAN|0.15||0.0844|TWO_SIDED|95.0|-0.54|0.03|||ANCOVA|||Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf worst pain, and baseline average LBPI as covariates, and study site as a random effect.||0.03|-0.54|0.0844
72516957|NCT02528253|144564391|SUPERIORITY||LS Mean Difference|-0.32|STANDARD_ERROR_OF_MEAN|0.14||0.0258|TWO_SIDED|95.0|-0.6|-0.04|||ANCOVA|||Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf worst pain, and baseline average LBPI as covariates, and study site as a random effect.||-0.04|-0.60|0.0258
72516958|NCT02528253|144564391|SUPERIORITY||LS Mean Difference|-0.52|STANDARD_ERROR_OF_MEAN|0.15||0.0004|TWO_SIDED|95.0|-0.8|-0.23|||ANCOVA|||Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf worst pain, and baseline average LBPI as covariates, and study site as a random effect.||-0.23|-0.80|0.0004
72516959|NCT02528253|144564391|SUPERIORITY||LS Mean Difference|-0.45|STANDARD_ERROR_OF_MEAN|0.17||0.0079|TWO_SIDED|95.0|-0.78|-0.12|||ANCOVA|||Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf worst pain, and baseline average LBPI as covariates, and study site as a random effect.||-0.12|-0.78|0.0079
72516960|NCT02528253|144564391|SUPERIORITY||LS Mean Difference|-0.75|STANDARD_ERROR_OF_MEAN|0.17|<|0.0001|TWO_SIDED|95.0|-1.08|-0.41|||ANCOVA|||Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf worst pain, and baseline average LBPI as covariates, and study site as a random effect.||-0.41|-1.08|<.0001
72516961|NCT02528253|144564391|SUPERIORITY||LS Mean Difference|-0.26|STANDARD_ERROR_OF_MEAN|0.16||0.0977|TWO_SIDED|95.0|-0.57|0.05|||ANCOVA|||Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf worst pain, and baseline average LBPI as covariates, and study site as a random effect.||0.05|-0.57|0.0977
72516962|NCT02528253|144564391|SUPERIORITY||LS Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.15||0.215|TWO_SIDED|95.0|-0.5|0.11|||ANCOVA|||Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf worst pain, and baseline average LBPI as covariates, and study site as a random effect.||0.11|-0.50|0.2150
72516963|NCT02528253|144564391|SUPERIORITY||LS Mean Difference|-0.49|STANDARD_ERROR_OF_MEAN|0.15||0.0016|TWO_SIDED|95.0|-0.79|-0.18|||ANCOVA|||Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf worst pain, and baseline average LBPI as covariates, and study site as a random effect.||-0.18|-0.79|0.0016
72516964|NCT02528253|144564391|SUPERIORITY||LS Mean Difference|-0.52|STANDARD_ERROR_OF_MEAN|0.19||0.0058|TWO_SIDED|95.0|-0.88|-0.15|||ANCOVA|||Change at Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf worst pain, and baseline average LBPI as covariates, and study site as a random effect.||-0.15|-0.88|0.0058
72516965|NCT02528253|144564391|SUPERIORITY||LS Mean Difference|-0.54|STANDARD_ERROR_OF_MEAN|0.19||0.0038|TWO_SIDED|95.0|-0.91|-0.18|||ANCOVA|||Change at Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf worst pain, and baseline average LBPI as covariates, and study site as a random effect.||-0.18|-0.91|0.0038
72568899|NCT00311311|144669049|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.006||||0.0514|TWO_SIDED|95.0|0.0|0.012||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA|LS mean difference||24 months post-transplant||0.012|-0.000|0.0514
72404761|NCT04206293|144317071|SUPERIORITY||LS Mean Difference|-0.081|STANDARD_ERROR_OF_MEAN|0.009|<|0.0001|TWO_SIDED|95.0|-0.102|-0.061|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||Ue: Change from Baseline to Day 84||-0.061|-0.102|<0.0001
72404762|NCT04206293|144317071|SUPERIORITY||LS Mean Difference|-0.079|STANDARD_ERROR_OF_MEAN|0.018||0.0003||95.0|-0.116|-0.041|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||Ur: Change from Baseline to Day 28||-0.041|-0.116|0.0003
72516966|NCT02528253|144564391|SUPERIORITY||LS Mean Difference|-0.24|STANDARD_ERROR_OF_MEAN|0.17||0.1707|TWO_SIDED|95.0|-0.58|0.1|||ANCOVA|||Change at Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf worst pain, and baseline average LBPI as covariates, and study site as a random effect.||0.10|-0.58|0.1707
72516967|NCT02528253|144564391|SUPERIORITY||LS Mean Difference|-0.28|STANDARD_ERROR_OF_MEAN|0.17||0.1083|TWO_SIDED|95.0|-0.62|0.06|||ANCOVA|||Change at Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf worst pain, and baseline average LBPI as covariates, and study site as a random effect.||0.06|-0.62|0.1083
72516968|NCT02528253|144564391|SUPERIORITY||LS Mean Difference|-0.31|STANDARD_ERROR_OF_MEAN|0.17||0.0734|TWO_SIDED|95.0|-0.64|0.03|||ANCOVA|||Change at Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf worst pain, and baseline average LBPI as covariates, and study site as a random effect.||0.03|-0.64|0.0734
72516969|NCT02528253|144564391|SUPERIORITY||LS Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.21||0.4603|TWO_SIDED|95.0|-0.56|0.25|||ANCOVA|||Change at Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf worst pain, and baseline average LBPI as covariates, and study site as a random effect.||0.25|-0.56|0.4603
72516970|NCT02528253|144564391|SUPERIORITY||LS Mean Difference|-0.35|STANDARD_ERROR_OF_MEAN|0.2||0.0799|TWO_SIDED|95.0|-0.74|0.04|||ANCOVA|||Change at Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf worst pain, and baseline average LBPI as covariates, and study site as a random effect.||0.04|-0.74|0.0799
72516971|NCT02528253|144564391|SUPERIORITY||LS Mean Difference|-0.25|STANDARD_ERROR_OF_MEAN|0.21||0.2339|TWO_SIDED|95.0|-0.66|0.16|||ANCOVA|||Change at Week 32: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf worst pain, and baseline average LBPI as covariates, and study site as a random effect.||0.16|-0.66|0.2339
72516972|NCT02528253|144564391|SUPERIORITY||LS Mean Difference|-0.32|STANDARD_ERROR_OF_MEAN|0.21||0.1199|TWO_SIDED|95.0|-0.73|0.08|||ANCOVA|||Change at Week 32: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf worst pain, and baseline average LBPI as covariates, and study site as a random effect.||0.08|-0.73|0.1199
72516973|NCT02528253|144564391|SUPERIORITY||LS Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.21||0.384|TWO_SIDED|95.0|-0.6|0.23|||ANCOVA|||Change at Week 40: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf worst pain, and baseline average LBPI as covariates, and study site as a random effect.||0.23|-0.60|0.3840
72516974|NCT02528253|144564391|SUPERIORITY||LS Mean Difference|-0.27|STANDARD_ERROR_OF_MEAN|0.21||0.2|TWO_SIDED|95.0|-0.68|0.14|||ANCOVA|||Change at Week 40: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf worst pain, and baseline average LBPI as covariates, and study site as a random effect.||0.14|-0.68|0.2000
72516975|NCT02528253|144564391|SUPERIORITY||LS Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.22||0.2997|TWO_SIDED|95.0|-0.65|0.2|||ANCOVA|||Change at Week 48: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf worst pain, and baseline average LBPI as covariates, and study site as a random effect.||0.20|-0.65|0.2997
72516976|NCT02528253|144564391|SUPERIORITY||LS Mean Difference|-0.29|STANDARD_ERROR_OF_MEAN|0.21||0.1778|TWO_SIDED|95.0|-0.71|0.13|||ANCOVA|||Change at Week 48: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf worst pain, and baseline average LBPI as covariates, and study site as a random effect.||0.13|-0.71|0.1778
72516977|NCT02528253|144564391|SUPERIORITY||LS Mean Difference|-0.21|STANDARD_ERROR_OF_MEAN|0.22||0.3438|TWO_SIDED|95.0|-0.65|0.23|||ANCOVA|||Change at Week 56: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf worst pain, and baseline average LBPI as covariates, and study site as a random effect.||0.23|-0.65|0.3438
72516978|NCT02528253|144564391|SUPERIORITY||LS Mean Difference|-0.29|STANDARD_ERROR_OF_MEAN|0.22||0.1876|TWO_SIDED|95.0|-0.71|0.14|||ANCOVA|||Change at Week 56: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf worst pain, and baseline average LBPI as covariates, and study site as a random effect.||0.14|-0.71|0.1876
72516979|NCT02528253|144564393|SUPERIORITY||LS Mean Difference|-0.47|STANDARD_ERROR_OF_MEAN|0.13||0.0002|TWO_SIDED|95.0|-0.72|-0.22|||ANCOVA|||Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf average pain, and baseline average LBPI as covariates, and study site as a random effect.||-0.22|-0.72|0.0002
72516980|NCT02528253|144564393|SUPERIORITY||LS Mean Difference|-0.54|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-0.79|-0.29|||ANCOVA|||Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf average pain, and baseline average LBPI as covariates, and study site as a random effect.||-0.29|-0.79|<.0001
72516981|NCT02528253|144564393|SUPERIORITY||LS Mean Difference|-0.27|STANDARD_ERROR_OF_MEAN|0.12||0.0193|TWO_SIDED|95.0|-0.5|-0.04|||ANCOVA|||Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf average pain, and baseline average LBPI as covariates, and study site as a random effect.||-0.04|-0.50|0.0193
72516982|NCT02528253|144564393|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.12||0.0845|TWO_SIDED|95.0|-0.42|0.03|||ANCOVA|||Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf average pain, and baseline average LBPI as covariates, and study site as a random effect.||0.03|-0.42|0.0845
72516983|NCT02528253|144564393|SUPERIORITY||LS Mean Difference|-0.27|STANDARD_ERROR_OF_MEAN|0.12||0.0212|TWO_SIDED|95.0|-0.49|-0.04|||ANCOVA|||Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf average pain, and baseline average LBPI as covariates, and study site as a random effect.||-0.04|-0.49|0.0212
72516984|NCT02528253|144564393|SUPERIORITY||LS Mean Difference|-0.53|STANDARD_ERROR_OF_MEAN|0.15||0.0003|TWO_SIDED|95.0|-0.81|-0.24|||ANCOVA|||Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf average pain, and baseline average LBPI as covariates, and study site as a random effect.||-0.24|-0.81|0.0003
72516985|NCT02528253|144564393|SUPERIORITY||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.15|<|0.0001|TWO_SIDED|95.0|-0.99|-0.41|||ANCOVA|||Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf average pain, and baseline average LBPI as covariates, and study site as a random effect.||-0.41|-0.99|<.0001
72516986|NCT02528253|144564393|SUPERIORITY||LS Mean Difference|-0.24|STANDARD_ERROR_OF_MEAN|0.14||0.079|TWO_SIDED|95.0|-0.5|0.03|||ANCOVA|||Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf worst pain, and baseline average LBPI as covariates, and study site as a random effect.||0.03|-0.50|0.0790
72516987|NCT02528253|144564393|SUPERIORITY||LS Mean Difference|-0.29|STANDARD_ERROR_OF_MEAN|0.14||0.0336|TWO_SIDED|95.0|-0.55|-0.02|||ANCOVA|||Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf average pain, and baseline average LBPI as covariates, and study site as a random effect.||-0.02|-0.55|0.0336
72516988|NCT02528253|144564393|SUPERIORITY||LS Mean Difference|-0.46|STANDARD_ERROR_OF_MEAN|0.14||0.0008|TWO_SIDED|95.0|-0.73|-0.19|||ANCOVA|||Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf average pain, and baseline average LBPI as covariates, and study site as a random effect.||-0.19|-0.73|0.0008
72516989|NCT02528253|144564393|SUPERIORITY||LS Mean Difference|-0.46|STANDARD_ERROR_OF_MEAN|0.16||0.0034|TWO_SIDED|95.0|-0.77|-0.15|||ANCOVA|||Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf average pain, and baseline average LBPI as covariates, and study site as a random effect.||-0.15|-0.77|0.0034
72516990|NCT02528253|144564393|SUPERIORITY||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.16|<|0.0001|TWO_SIDED|95.0|-1.01|-0.39|||ANCOVA|||Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf average pain, and baseline average LBPI as covariates, and study site as a random effect.||-0.39|-1.01|<.0001
72516991|NCT02528253|144564393|SUPERIORITY||LS Mean Difference|-0.31|STANDARD_ERROR_OF_MEAN|0.15||0.0361|TWO_SIDED|95.0|-0.59|-0.02|||ANCOVA|||Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf average pain, and baseline average LBPI as covariates, and study site as a random effect.||-0.02|-0.59|0.0361
72516992|NCT02528253|144564393|SUPERIORITY||LS Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.15||0.2786|TWO_SIDED|95.0|-0.44|0.13|||ANCOVA|||Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf average pain, and baseline average LBPI as covariates, and study site as a random effect.||0.13|-0.44|0.2786
72516993|NCT02528253|144564393|SUPERIORITY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.14||0.0058|TWO_SIDED|95.0|-0.68|-0.11|||ANCOVA|||Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf average pain, and baseline average LBPI as covariates, and study site as a random effect.||-0.11|-0.68|0.0058
72516994|NCT02528253|144564393|SUPERIORITY||LS Mean Difference|-0.37|STANDARD_ERROR_OF_MEAN|0.18||0.0365|TWO_SIDED|95.0|-0.71|-0.02|||ANCOVA|||Change at Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf average pain, and baseline average LBPI as covariates, and study site as a random effect.||-0.02|-0.71|0.0365
72516995|NCT02528253|144564393|SUPERIORITY||LS Mean Difference|-0.46|STANDARD_ERROR_OF_MEAN|0.18||0.0092|TWO_SIDED|95.0|-0.8|-0.11|||ANCOVA|||Change at Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf average pain, and baseline average LBPI as covariates, and study site as a random effect.||-0.11|-0.80|0.0092
72568900|NCT00311311|144669049|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.009||||0.118|TWO_SIDED|95.0|-0.002|0.02||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|36 months post-transplant||0.020|-0.002|0.1180
72404763|NCT04206293|144317071|SUPERIORITY||LS Mean Difference|-0.074|STANDARD_ERROR_OF_MEAN|0.013||0.0001|TWO_SIDED|95.0|-0.103|-0.044|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||Ur: Change from Baseline to Day 84||-0.044|-0.103|0.0001
72404764|NCT04206293|144317071|SUPERIORITY||LS Mean Difference|-0.081|STANDARD_ERROR_OF_MEAN|0.017||0.0002|TWO_SIDED|95.0|-0.117|-0.045|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||Ua: Change from Baseline to Day 28||-0.045|-0.117|0.0002
72404765|NCT04206293|144317071|SUPERIORITY||LS Mean Difference|-0.077|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|-0.103|-0.052|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||Ua: Change from Baseline to Day 84||-0.052|-0.103|<0.0001
72404766|NCT04206293|144317072|SUPERIORITY||LS Mean Difference|-0.008|STANDARD_ERROR_OF_MEAN|0.014||0.5786|TWO_SIDED|95.0|-0.038|0.022|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||Q1: Change from Baseline to Day 28||0.022|-0.038|0.5786
72404767|NCT04206293|144317072|SUPERIORITY||LS Mean Difference|-0.023|STANDARD_ERROR_OF_MEAN|0.012||0.069|TWO_SIDED|95.0|-0.049|0.002|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||Q1: Change from Baseline to Day 84||0.002|-0.049|0.0690
72404768|NCT04206293|144317072|SUPERIORITY||LS Mean Difference|-0.021|STANDARD_ERROR_OF_MEAN|0.016||0.1934|TWO_SIDED|95.0|-0.054|0.012|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||Q2: Change from Baseline to Day 28||0.012|-0.054|0.1934
72490663|NCT02873936|144508841|SUPERIORITY||Least Squares Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|0.17|<|0.001|TWO_SIDED|95.0|-1.5|-0.8||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.8|-1.5|<0.001
72490664|NCT02873936|144508841|SUPERIORITY||Least Squares Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.17|<|0.001|TWO_SIDED|95.0|-1.1|-0.4||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.4|-1.1|<0.001
72490665|NCT02873936|144508842|SUPERIORITY||Difference in Response Rates|12.3||||0.004|TWO_SIDED|95.0|3.5|21.2||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg vs Placebo at Week 4.||21.2|3.5|0.004
72404769|NCT04206293|144317072|SUPERIORITY||LS Mean Difference|-0.034|STANDARD_ERROR_OF_MEAN|0.013||0.0194|TWO_SIDED|95.0|-0.062|-0.006|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||Q2: Change from Baseline to Day 84||-0.006|-0.062|0.0194
72490666|NCT02873936|144508842|SUPERIORITY||Difference in Response Rates|12.8||||0.003|TWO_SIDED|95.0|4.0|21.5||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg vs Placebo at Week 4.||21.5|4.0|0.003
72516996|NCT02528253|144564393|SUPERIORITY||LS Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.16||0.2923|TWO_SIDED|95.0|-0.49|0.15|||ANCOVA|||Change at Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf average pain, and baseline average LBPI as covariates, and study site as a random effect.||0.15|-0.49|0.2923
72516997|NCT02528253|144564393|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.16||0.2231|TWO_SIDED|95.0|-0.51|0.12|||ANCOVA|||Change at Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf average pain, and baseline average LBPI as covariates, and study site as a random effect.||0.12|-0.51|0.2231
72516998|NCT02528253|144564393|SUPERIORITY||LS Mean Difference|-0.29|STANDARD_ERROR_OF_MEAN|0.16||0.0724|TWO_SIDED|95.0|-0.6|0.03|||ANCOVA|||Change at Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf average pain, and baseline average LBPI as covariates, and study site as a random effect.||0.03|-0.60|0.0724
72516999|NCT02528253|144564393|SUPERIORITY||LS Mean Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.19||0.4776|TWO_SIDED|95.0|-0.5|0.23|||ANCOVA|||Change at Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf average pain, and baseline average LBPI as covariates, and study site as a random effect.||0.23|-0.50|0.4776
72517000|NCT02528253|144564393|SUPERIORITY||LS Mean Difference|-0.27|STANDARD_ERROR_OF_MEAN|0.19||0.1482|TWO_SIDED|95.0|-0.64|0.1|||ANCOVA|||Change at Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf average pain, and baseline average LBPI as covariates, and study site as a random effect.||0.10|-0.64|0.1482
72517001|NCT02528253|144564393|SUPERIORITY||LS Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.19||0.3249|TWO_SIDED|95.0|-0.56|0.18|||ANCOVA|||Change at Week 32: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf average pain, and baseline average LBPI as covariates, and study site as a random effect.||0.18|-0.56|0.3249
72517002|NCT02528253|144564393|SUPERIORITY||LS Mean Difference|-0.24|STANDARD_ERROR_OF_MEAN|0.19||0.1997|TWO_SIDED|95.0|-0.62|0.13|||ANCOVA|||Change at Week 32: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf average pain, and baseline average LBPI as covariates, and study site as a random effect.||0.13|-0.62|0.1997
72490667|NCT02873936|144508842|SUPERIORITY||Difference in Response Rates|27.4|||<|0.001|TWO_SIDED|95.0|16.3|38.4||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg vs Placebo at Week 24.||38.4|16.3|<0.001
72490668|NCT02873936|144508842|SUPERIORITY||Difference in Response Rates|17.0||||0.001|TWO_SIDED|95.0|6.2|27.7||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg vs Placebo at Week 24.||27.7|6.2|0.001
72490669|NCT02873936|144508843|SUPERIORITY||Difference in Response Rates|7.5||||0.012|TWO_SIDED|95.0|1.3|13.7||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg vs Placebo at Week 4.||13.7|1.3|0.012
72490670|NCT02873936|144508843|SUPERIORITY||Difference in Response Rates|9.1||||0.006|TWO_SIDED|95.0|2.7|15.5||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg vs Placebo at Week 4.||15.5|2.7|0.006
72490671|NCT02873936|144508843|SUPERIORITY||Difference in Response Rates|14.3|||<|0.001|TWO_SIDED|95.0|5.6|23.1||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg vs Placebo at Week 12.||23.1|5.6|<0.001
72490672|NCT02873936|144508843|SUPERIORITY||Difference in Response Rates|17.4|||<|0.001|TWO_SIDED|95.0|8.5|26.2||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg vs Placebo at Week 12.||26.2|8.5|<0.001
72517003|NCT02528253|144564393|SUPERIORITY||LS Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.2||0.4823|TWO_SIDED|95.0|-0.53|0.25|||ANCOVA|||Change at Week 40: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf average pain, and baseline average LBPI as covariates, and study site as a random effect.||0.25|-0.53|0.4823
72568901|NCT00311311|144669050|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.56||||0.0016|TWO_SIDED|95.0|2.2|8.93||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|12 months post-transplant||8.93|2.20|0.0016
72490673|NCT02873936|144508846|SUPERIORITY||Least Squares Mean Difference|-7.1|STANDARD_ERROR_OF_MEAN|1.47|<|0.001|TWO_SIDED|95.0|-10.0|-4.2||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-4.2|-10.0|<0.001
72490674|NCT02873936|144508846|SUPERIORITY||Least Squares Mean Difference|-5.0|STANDARD_ERROR_OF_MEAN|1.46|<|0.001|TWO_SIDED|95.0|-7.9|-2.2||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-2.2|-7.9|<0.001
72490675|NCT02873936|144508846|SUPERIORITY||Least Squares Mean Difference|-9.5|STANDARD_ERROR_OF_MEAN|1.56|<|0.001|TWO_SIDED|95.0|-12.6|-6.5||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-6.5|-12.6|<0.001
72517004|NCT02528253|144564393|SUPERIORITY||LS Mean Difference|-0.21|STANDARD_ERROR_OF_MEAN|0.2||0.2754|TWO_SIDED|95.0|-0.6|0.17|||ANCOVA|||Change at Week 40: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf average pain, and baseline average LBPI as covariates, and study site as a random effect.||0.17|-0.60|0.2754
72517005|NCT02528253|144564393|SUPERIORITY||LS Mean Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.2||0.5861|TWO_SIDED|95.0|-0.5|0.29|||ANCOVA|||Change at Week 48: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf average pain, and baseline average LBPI as covariates, and study site as a random effect.||0.29|-0.50|0.5861
72568902|NCT00311311|144669050|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.91||||0.0091|TWO_SIDED|95.0|1.01|6.8||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|24 months post-transplant||6.80|1.01|0.0091
72568903|NCT00311311|144669050|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.25||||0.2468|TWO_SIDED|95.0|-1.6|6.1||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|36 months post-transplant||6.10|-1.60|0.2468
72568904|NCT00311311|144669051|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.95||||0.5282|TWO_SIDED|95.0|-2.05|3.94||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|12 months post-transplant||3.94|-2.05|0.5282
72568905|NCT00311311|144669051|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.27||||0.5057|TWO_SIDED|95.0|-2.53|5.07||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|24 months post-transplant||5.07|-2.53|0.5057
72568906|NCT00311311|144669051|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.59||||0.5701|TWO_SIDED|95.0|-4.0|7.18||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|36 months post-transplant||7.18|-4.00|0.5701
72568907|NCT00311311|144669053|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.26||||0.028|TWO_SIDED|95.0|0.03|0.48||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA|||12 months post-transplant||0.48|0.03|0.0280
72568908|NCT00311311|144669053|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.26||||0.019|TWO_SIDED|95.0|0.04|0.48||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA|||24 months post-transplant||0.48|0.04|0.0190
72568909|NCT00311311|144669053|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.27||||0.1182|TWO_SIDED|95.0|-0.07|0.6||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA|||36 months post-transplant||0.60|-0.07|0.1182
72568910|NCT00311311|144669054|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3||||0.7361|TWO_SIDED|95.0|-2.09|1.49||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|12 months post-transplant||1.49|-2.09|0.7361
72404770|NCT04206293|144317072|SUPERIORITY||LS Mean Difference|0.013|STANDARD_ERROR_OF_MEAN|0.007||0.0652|TWO_SIDED|95.0|-0.001|0.028|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||Q3: Change from Baseline to Day 28||0.028|-0.001|0.0652
72568911|NCT00311311|144669054|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.53||||0.5549|TWO_SIDED|95.0|-2.32|1.26||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|24 months post-transplant||1.26|-2.32|0.5549
72568912|NCT00311311|144669054|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.76||||0.6058|TWO_SIDED|95.0|-3.69|2.17||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|36 months post-transplant||2.17|-3.69|0.6058
72568913|NCT00311311|144669055|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.6||||0.5902|TWO_SIDED|95.0|-1.63|2.84||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|12 months post-transplant||2.84|-1.63|0.5902
72568914|NCT00311311|144669055|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.36||||0.7536|TWO_SIDED|95.0|-2.68|1.95||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|24 months post-transplant||1.95|-2.68|0.7536
72568915|NCT00311311|144669055|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.33||||0.4066|TWO_SIDED|95.0|-4.53|1.86||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|36 months post-transplant||1.86|-4.53|0.4066
72568916|NCT00311311|144669056|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.47||||0.3678|TWO_SIDED|95.0|-11.46|30.4||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|12 months post-transplant||30.40|-11.46|0.3678
72568917|NCT00311311|144669056|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.72||||0.2179|TWO_SIDED|95.0|-6.53|27.97||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|24 months post-transplant||27.97|-6.53|0.2179
72404771|NCT04206293|144317072|SUPERIORITY||LS Mean Difference|0.012|STANDARD_ERROR_OF_MEAN|0.006||0.0756|TWO_SIDED|95.0|-0.001|0.024|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||Q3: Change from Baseline to Day 84||0.024|-0.001|0.0756
72490676|NCT02873936|144508846|SUPERIORITY||Least Squares Mean Difference|-7.6|STANDARD_ERROR_OF_MEAN|1.55|<|0.001|TWO_SIDED|95.0|-10.6|-4.5||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-4.5|-10.6|<0.001
72490677|NCT02873936|144508846|SUPERIORITY||Least Squares Mean Difference|-8.7|STANDARD_ERROR_OF_MEAN|1.64|<|0.001|TWO_SIDED|95.0|-11.9|-5.5||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-5.5|-11.9|<0.001
72490678|NCT02873936|144508846|SUPERIORITY||Least Squares Mean Difference|-4.9|STANDARD_ERROR_OF_MEAN|1.66||0.003|TWO_SIDED|95.0|-8.2|-1.6||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-1.6|-8.2|0.003
72490679|NCT02873936|144508847|SUPERIORITY||Least Squares Mean Difference|-8.1|STANDARD_ERROR_OF_MEAN|1.52|<|0.001|TWO_SIDED|95.0|-11.1|-5.1||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-5.1|-11.1|<0.001
72490680|NCT02873936|144508847|SUPERIORITY||Least Squares Mean Difference|-5.9|STANDARD_ERROR_OF_MEAN|1.52|<|0.001|TWO_SIDED|95.0|-8.9|-2.9||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-2.9|-8.9|<0.001
72490681|NCT02873936|144508847|SUPERIORITY||Least Squares Mean Difference|-10.7|STANDARD_ERROR_OF_MEAN|1.6|<|0.001|TWO_SIDED|95.0|-13.8|-7.5||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-7.5|-13.8|<0.001
72490682|NCT02873936|144508847|SUPERIORITY||Least Squares Mean Difference|-8.7|STANDARD_ERROR_OF_MEAN|1.59|<|0.001|TWO_SIDED|95.0|-11.8|-5.5||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-5.5|-11.8|<0.001
72490683|NCT02873936|144508847|SUPERIORITY||Least Squares Mean Difference|-10.1|STANDARD_ERROR_OF_MEAN|1.7|<|0.001|TWO_SIDED|95.0|-13.5|-6.8||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-6.8|-13.5|<0.001
72490684|NCT02873936|144508847|SUPERIORITY||Least Squares Mean Difference|-6.1|STANDARD_ERROR_OF_MEAN|1.71|<|0.001|TWO_SIDED|95.0|-9.4|-2.7||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-2.7|-9.4|<0.001
72490685|NCT02873936|144508849|SUPERIORITY||Least Squares Mean Difference|2.5|STANDARD_ERROR_OF_MEAN|0.7|<|0.001|TWO_SIDED|95.0|1.1|3.9||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||3.9|1.1|<0.001
72517006|NCT02528253|144564393|SUPERIORITY||LS Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.2||0.4346|TWO_SIDED|95.0|-0.54|0.23|||ANCOVA|||Change at Week 48: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf average pain, and baseline average LBPI as covariates, and study site as a random effect.||0.23|-0.54|0.4346
72517007|NCT02528253|144564393|SUPERIORITY||LS Mean Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.2||0.8752|TWO_SIDED|95.0|-0.42|0.36|||ANCOVA|||Change at Week 56: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf average pain, and baseline average LBPI as covariates, and study site as a random effect.||0.36|-0.42|0.8752
72517008|NCT02528253|144564393|SUPERIORITY||LS Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.2||0.2663|TWO_SIDED|95.0|-0.6|0.17|||ANCOVA|||Change at Week 56: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf average pain, and baseline average LBPI as covariates, and study site as a random effect.||0.17|-0.60|0.2663
72568918|NCT00311311|144669056|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.96||||0.3663|TWO_SIDED|95.0|-14.39|38.32||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|36 months post-transplant||38.32|-14.39|0.3663
72404772|NCT04206293|144317073|SUPERIORITY||LS Mean Difference|-0.55|STANDARD_ERROR_OF_MEAN|2.68||0.8409|TWO_SIDED|95.0|-6.19|5.1|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||Change from Baseline to Day 28||5.10|-6.19|0.8409
72568919|NCT00311311|144669057|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.4||||0.041|TWO_SIDED|95.0|0.0|0.8||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|12 months post-transplant||0.8|0.0|0.0410
72568920|NCT00311311|144669057|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3||||0.0275|TWO_SIDED|95.0|0.0|0.6||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|24 months post-transplant||0.6|0.0|0.0275
72568921|NCT00311311|144669057|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2||||0.1841|TWO_SIDED|95.0|-0.1|0.6||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|36 months post-transplant||0.6|-0.1|0.1841
72568922|NCT00311311|144669058|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-51.3||||0.0797|TWO_SIDED|95.0|-108.9|6.3||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA|LS mean difference||12 months post-transplant||6.3|-108.9|0.0797
72568923|NCT00311311|144669058|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-33.3||||0.2341|TWO_SIDED|95.0|-88.7|22.2||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA|LS mean difference||24 months post-transplant||22.2|-88.7|0.2341
72568924|NCT00311311|144669058|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.2||||0.6854|TWO_SIDED|95.0|-90.3|59.8||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|36 months post-transplant||59.8|-90.3|0.6854
72568925|NCT00311311|144669059|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-72.8||||0.0002|TWO_SIDED|95.0|-108.6|-36.9||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|12 months post-transplant||-36.9|-108.6|0.0002
72404773|NCT04206293|144317073|SUPERIORITY||LS Mean Difference|-0.42|STANDARD_ERROR_OF_MEAN|3.98||0.9183|TWO_SIDED|95.0|-9.18|8.35|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||Change from Baseline to Day 84||8.35|-9.18|0.9183
72568926|NCT00311311|144669059|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-67.6||||0.0017|TWO_SIDED|95.0|-108.5|-26.6||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|24 months post-transplant||-26.6|-108.5|0.0017
72404774|NCT04206293|144317074|SUPERIORITY||LS Mean Difference|70.0|STANDARD_ERROR_OF_MEAN|77.0||0.4128|TWO_SIDED|95.0|-142.0|282.0|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||Change from Baseline to Day 28||282|-142|0.4128
72404775|NCT04206293|144317074|SUPERIORITY||LS Mean Difference|-82.0|STANDARD_ERROR_OF_MEAN|79.0||0.3851|TWO_SIDED|95.0|-355.0|191.0|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||Change from Baseline to Day 84||191|-355|0.3851
72568927|NCT00311311|144669059|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-62.3||||0.0293|TWO_SIDED|95.0|-118.2|-6.5||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|36 months post-transplant||-6.5|-118.2|0.0293
72568928|NCT00311311|144669061|SUPERIORITY_OR_OTHER|||||||0.2573|TWO_SIDED|||||P-value was calculated from 2-sided Fisher's exact test. Alpha is unadjusted.|Fisher Exact|||Use Lipid-Lowering From Consent to Conversion||||0.2573
72568929|NCT00311311|144669061|SUPERIORITY_OR_OTHER|||||||0.6386|TWO_SIDED|||||P-value was calculated from 2-sided Fisher's exact test. Alpha is unadjusted.|Fisher Exact|||Use Lipid-Lowering From Conversion to Month 12||||0.6386
72568930|NCT00311311|144669061|SUPERIORITY_OR_OTHER|||||||0.0709|TWO_SIDED|||||P-value was calculated from 2-sided Fisher's exact test. Alpha is unadjusted.|Fisher Exact|||Use Lipid-Lowering From Month 12 to Month 24||||0.0709
72568931|NCT00311311|144669061|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED|||||P-value was calculated from 2-sided Fisher's exact test. Alpha is unadjusted.|Fisher Exact|||Use Lipid-Lowering From Month 24 to Month 36||||1.0000
72568932|NCT00311311|144669062|SUPERIORITY_OR_OTHER|||||||0.4286|TWO_SIDED|||||P-value was calculated from 2-sided Fisher's exact test. Alpha is unadjusted.|Fisher Exact|||Use Anti-hypertension From Consent to Conversion||||0.4286
72517009|NCT02528253|144564395|SUPERIORITY||LS Mean Difference|-0.48|STANDARD_ERROR_OF_MEAN|0.15||0.0013|TWO_SIDED|95.0|-0.77|-0.19|||ANCOVA|||Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference index, and baseline average LBPI as covariates, and study site as a random effect.||-0.19|-0.77|0.0013
72517010|NCT02528253|144564395|SUPERIORITY||LS Mean Difference|-0.57|STANDARD_ERROR_OF_MEAN|0.15||0.0001|TWO_SIDED|95.0|-0.87|-0.28|||ANCOVA|||Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference index, and baseline average LBPI as covariates, and study site as a random effect.||-0.28|-0.87|0.0001
72517011|NCT02528253|144564395|SUPERIORITY||LS Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.14||0.2272|TWO_SIDED|95.0|-0.43|-0.1|||ANCOVA|||Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference index, and baseline average LBPI as covariates, and study site as a random effect.||-0.10|-0.43|0.2272
72517012|NCT02528253|144564395|SUPERIORITY||LS Mean Difference|-0.31|STANDARD_ERROR_OF_MEAN|0.14||0.0209|TWO_SIDED|95.0|-0.58|-0.05|||ANCOVA|||Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference index, and baseline average LBPI as covariates, and study site as a random effect.||-0.05|-0.58|0.0209
72517013|NCT02528253|144564395|SUPERIORITY||LS Mean Difference|-0.41|STANDARD_ERROR_OF_MEAN|0.14||0.0029|TWO_SIDED|95.0|-0.67|-0.14|||ANCOVA|||Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference index, and baseline average LBPI as covariates, and study site as a random effect.||-0.14|-0.67|0.0029
72517014|NCT02528253|144564395|SUPERIORITY||LS Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.16||0.0002|TWO_SIDED|95.0|-0.92|-0.28|||ANCOVA|||Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference index, and baseline average LBPI as covariates, and study site as a random effect.||-0.28|-0.92|0.0002
72517015|NCT02528253|144564395|SUPERIORITY||LS Mean Difference|-0.78|STANDARD_ERROR_OF_MEAN|0.16|<|0.0001|TWO_SIDED|95.0|-1.1|-0.46|||ANCOVA|||Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference index, and baseline average LBPI as covariates, and study site as a random effect.||-0.46|-1.10|<.0001
72517016|NCT02528253|144564395|SUPERIORITY||LS Mean Difference|-0.23|STANDARD_ERROR_OF_MEAN|0.15||0.1198|TWO_SIDED|95.0|-0.53|0.06|||ANCOVA|||Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference index, and baseline average LBPI as covariates, and study site as a random effect.||0.06|-0.53|0.1198
72517017|NCT02528253|144564395|SUPERIORITY||LS Mean Difference|-0.37|STANDARD_ERROR_OF_MEAN|0.15||0.016|TWO_SIDED|95.0|-0.66|-0.07|||ANCOVA|||Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference index, and baseline average LBPI as covariates, and study site as a random effect.||-0.07|-0.66|0.0160
72517018|NCT02528253|144564395|SUPERIORITY||LS Mean Difference|-0.55|STANDARD_ERROR_OF_MEAN|0.15||0.0003|TWO_SIDED|95.0|-0.85|-0.25|||ANCOVA|||Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference index, and baseline average LBPI as covariates, and study site as a random effect.||-0.25|-0.85|0.0003
72517019|NCT02528253|144564395|SUPERIORITY||LS Mean Difference|-0.44|STANDARD_ERROR_OF_MEAN|0.17||0.0091|TWO_SIDED|95.0|-0.77|-0.11|||ANCOVA|||Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference index, and baseline average LBPI as covariates, and study site as a random effect.||-0.11|-0.77|0.0091
72517020|NCT02528253|144564395|SUPERIORITY||LS Mean Difference|-0.57|STANDARD_ERROR_OF_MEAN|0.17||0.0007|TWO_SIDED|95.0|-0.9|-0.24|||ANCOVA|||Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference index, and baseline average LBPI as covariates, and study site as a random effect.||-0.24|-0.90|0.0007
72517021|NCT02528253|144564395|SUPERIORITY||LS Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.15||0.2264|TWO_SIDED|95.0|-0.48|0.11|||ANCOVA|||Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference index, and baseline average LBPI as covariates, and study site as a random effect.||0.11|-0.48|0.2264
72517022|NCT02528253|144564395|SUPERIORITY||LS Mean Difference|-0.26|STANDARD_ERROR_OF_MEAN|0.15||0.0961|TWO_SIDED|95.0|-0.56|0.05|||ANCOVA|||Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference index, and baseline average LBPI as covariates, and study site as a random effect.||0.05|-0.56|0.0961
72517023|NCT02528253|144564395|SUPERIORITY||LS Mean Difference|-0.39|STANDARD_ERROR_OF_MEAN|0.15||0.0121|TWO_SIDED|95.0|-0.69|-0.08|||ANCOVA|||Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference index, and baseline average LBPI as covariates, and study site as a random effect.||-0.08|-0.69|0.0121
72568933|NCT00311311|144669062|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED|||||P-value was calculated from 2-sided Fisher's exact test. Alpha is unadjusted.|Fisher Exact|||Use Anti-hypertension From Conversion to Month 12||||1.0000
72517024|NCT02528253|144564395|SUPERIORITY||LS Mean Difference|-0.41|STANDARD_ERROR_OF_MEAN|0.18||0.027|TWO_SIDED|95.0|-0.77|-0.05|||ANCOVA|||Change at Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference index, and baseline average LBPI as covariates, and study site as a random effect.||-0.05|-0.77|0.0270
72517025|NCT02528253|144564395|SUPERIORITY||LS Mean Difference|-0.58|STANDARD_ERROR_OF_MEAN|0.18||0.0019|TWO_SIDED|95.0|-0.94|-0.21|||ANCOVA|||Change at Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference index, and baseline average LBPI as covariates, and study site as a random effect.||-0.21|-0.94|0.0019
72517026|NCT02528253|144564395|SUPERIORITY||LS Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.17||0.3906|TWO_SIDED|95.0|-0.48|0.19|||ANCOVA|||Change at Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference index, and baseline average LBPI as covariates, and study site as a random effect.||0.19|-0.48|0.3906
72517027|NCT02528253|144564395|SUPERIORITY||LS Mean Difference|-0.26|STANDARD_ERROR_OF_MEAN|0.17||0.1209|TWO_SIDED|95.0|-0.59|0.07|||ANCOVA|||Change at Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference index, and baseline average LBPI as covariates, and study site as a random effect.||0.07|-0.59|0.1209
72404776|NCT04206293|144317075|SUPERIORITY||LS Mean Difference|6.52|STANDARD_ERROR_OF_MEAN|3.44||0.0798|TWO_SIDED|95.0|-0.89|13.93|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||Change from Baseline to Day 28||13.93|-0.89|0.0798
72517028|NCT02528253|144564395|SUPERIORITY||LS Mean Difference|-0.43|STANDARD_ERROR_OF_MEAN|0.17||0.0107|TWO_SIDED|95.0|-0.76|-0.1|||ANCOVA|||Change at Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference index, and baseline average LBPI as covariates, and study site as a random effect.||-0.10|-0.76|0.0107
72517029|NCT02528253|144564395|SUPERIORITY||LS Mean Difference|-0.23|STANDARD_ERROR_OF_MEAN|0.19||0.2396|TWO_SIDED|95.0|-0.61|0.15|||ANCOVA|||Change at Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference index, and baseline average LBPI as covariates, and study site as a random effect.||0.15|-0.61|0.2396
72517030|NCT02528253|144564395|SUPERIORITY||LS Mean Difference|-0.31|STANDARD_ERROR_OF_MEAN|0.19||0.1088|TWO_SIDED|95.0|-0.69|0.07|||ANCOVA|||Change at Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference index, and baseline average LBPI as covariates, and study site as a random effect.||0.07|-0.69|0.1088
72568934|NCT00311311|144669062|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED|||||P-value was calculated from 2-sided Fisher's exact test. Alpha is unadjusted.|Fisher Exact|||Use Anti-hypertension From Month 12 to Month 24||||1.0000
72568935|NCT00311311|144669062|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED|||||P-value was calculated from 2-sided Fisher's exact test. Alpha is unadjusted.|Fisher Exact|||Use Anti-hypertension From Month 24 to Month 36||||1.0000
72568936|NCT00311311|144669063|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-18.0||||0.2718|TWO_SIDED|95.0|-50.7|14.7||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value, treatment group, time, and treatment group by time interaction as fixed effects, and subjects as random effect.|ANCOVA||LS mean difference|18 months post-transplant||14.7|-50.7|0.2718
72568937|NCT00311311|144669063|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.7||||0.2729|TWO_SIDED|95.0|-41.6|12.1||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value, treatment group, time, and treatment group by time interaction as fixed effects, and subjects as random effect.|ANCOVA||LS mean difference|24 months post-transplant||12.1|-41.6|0.2729
72568938|NCT00311311|144669063|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.2||||0.2902|TWO_SIDED|95.0|-23.8|7.3||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value, treatment group, time, and treatment group by time interaction as fixed effects, and subjects as random effect.|ANCOVA||LS mean difference|36 months post-transplant||7.3|-23.8|0.2902
72568939|NCT01610453|144669064|SUPERIORITY_OR_OTHER||||||<|0.01||||||A sample size calculation with alpha 0.05, power 0.8, and cut-off level of HPD at 40 mm. 146 women should be included. The calculation was based from a previous study, in which 93% with HPD ≤40 mm and 57% of with HPD \> 40 mm delivered vaginally.|Chi-squared|||Women were categorized in accordance to fetal descent measured by ultrasound. Head-perineum distance ≤40 mm was used as cut-off level. Vaginal delivery was the primary outcome measure.||||<0.01
72568940|NCT01610453|144669065|SUPERIORITY_OR_OTHER|||||||0.01|||||||Chi-squared|||||||0.01
72568941|NCT00988065|144669069|SUPERIORITY_OR_OTHER||Difference in event rates|0.7||||||95.0|-1.8|3.7|||||95% confidence interval for the difference in event rates (treatment group minus placebo) according to Miettinen and Nurminen (Statistics in Medicine 1985; 4:213-226).|||3.7|-1.8|
72568942|NCT00988065|144669069|SUPERIORITY_OR_OTHER||Difference in event rates|4.7||||||95.0|2.1|9.3|||||95% confidence interval for the difference in event rates (treatment group minus placebo) according to Miettinen and Nurminen (Statistics in Medicine 1985; 4:213-226).|||9.3|2.1|
72568943|NCT00988065|144669070|SUPERIORITY_OR_OTHER||Difference in event rates|0.7||||||95.0|-1.8|3.7|||||95% confidence interval for the difference in event rates (treatment group minus placebo) according to Miettinen and Nurminen (Statistics in Medicine 1985; 4:213-226).|||3.7|-1.8|
72490686|NCT02873936|144508849|SUPERIORITY||Least Squares Mean Difference|2.0|STANDARD_ERROR_OF_MEAN|0.7||0.005|TWO_SIDED|95.0|0.6|3.4||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||3.4|0.6|0.005
72490687|NCT02873936|144508849|SUPERIORITY||Least Squares Mean Difference|3.9|STANDARD_ERROR_OF_MEAN|1.02|<|0.001|TWO_SIDED|95.0|1.9|5.9||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||5.9|1.9|<0.001
72490688|NCT02873936|144508849|SUPERIORITY||Least Squares Mean Difference|3.1|STANDARD_ERROR_OF_MEAN|1.03||0.002|TWO_SIDED|95.0|1.1|5.2||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||5.2|1.1|0.002
72490689|NCT02873936|144508851|SUPERIORITY||Least Squares Mean Difference|2.3|STANDARD_ERROR_OF_MEAN|0.97||0.019|TWO_SIDED|95.0|0.4|4.2||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||4.2|0.4|0.019
72490690|NCT02873936|144508851|SUPERIORITY||Least Squares Mean Difference|1.7|STANDARD_ERROR_OF_MEAN|0.97||0.073|TWO_SIDED|95.0|-0.2|3.6||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||3.6|-0.2|0.073
72490691|NCT02873936|144508851|SUPERIORITY||Least Squares Mean Difference|2.1|STANDARD_ERROR_OF_MEAN|1.03||0.045|TWO_SIDED|95.0|0.0|4.1||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||4.1|0.0|0.045
72490692|NCT02873936|144508851|SUPERIORITY||Least Squares Mean Difference|1.0|STANDARD_ERROR_OF_MEAN|1.02||0.32|TWO_SIDED|95.0|-1.0|3.0||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||3.0|-1.0|0.32
72490693|NCT02873936|144508851|SUPERIORITY||Least Squares Mean Difference|1.9|STANDARD_ERROR_OF_MEAN|1.19||0.12|TWO_SIDED|95.0|-0.5|4.2||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||4.2|-0.5|0.12
72490694|NCT02873936|144508851|SUPERIORITY||Least Squares Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|1.2||0.96|TWO_SIDED|95.0|-2.3|2.4||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||2.4|-2.3|0.96
72517031|NCT02528253|144564395|SUPERIORITY||LS Mean Difference|-0.27|STANDARD_ERROR_OF_MEAN|0.2||0.1673|TWO_SIDED|95.0|-0.65|0.11|||ANCOVA|||Change at Week 32: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference index, and baseline average LBPI as covariates, and study site as a random effect.||0.11|-0.65|0.1673
72404777|NCT04206293|144317075|SUPERIORITY||LS Mean Difference|5.56|STANDARD_ERROR_OF_MEAN|3.27||0.1142|TWO_SIDED|95.0|-1.55|12.67|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||Change from Baseline to Day 84||12.67|-1.55|0.1142
72404778|NCT04206293|144317076|SUPERIORITY||LS Mean Difference|0.96|STANDARD_ERROR_OF_MEAN|0.82||0.2592|TWO_SIDED|95.0|-0.78|2.71|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||Ra: Change from Baseline to Day 28||2.71|-0.78|0.2592
72490695|NCT02873936|144508853|SUPERIORITY||Least Squares Mean Difference|3.7|STANDARD_ERROR_OF_MEAN|1.05|<|0.001|TWO_SIDED|95.0|1.6|5.7||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||5.7|1.6|<0.001
72404779|NCT04206293|144317076|SUPERIORITY||LS Mean Difference|1.09|STANDARD_ERROR_OF_MEAN|0.69||0.1341|TWO_SIDED|95.0|-0.38|2.57|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||Ra: Change from Baseline to Day 84||2.57|-0.38|0.1341
72404780|NCT04206293|144317076|SUPERIORITY||LS Mean Difference|5.91|STANDARD_ERROR_OF_MEAN|4.55||0.2138|TWO_SIDED|95.0|-3.79|15.61|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||Rz: Change from Baseline to Day 28||15.61|-3.79|0.2138
72404781|NCT04206293|144317076|SUPERIORITY||LS Mean Difference|8.22|STANDARD_ERROR_OF_MEAN|4.2||0.07|TWO_SIDED|95.0|-0.77|17.2|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||Rz: Change from Baseline to Day 84||17.20|-0.77|0.0700
72404782|NCT04206293|144317077|SUPERIORITY||LS Mean Difference|0.11|STANDARD_ERROR_OF_MEAN|2.17||0.9608|TWO_SIDED|95.0|-4.7|4.91|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||Change from Baseline to Day 28||4.91|-4.70|0.9608
72490696|NCT02873936|144508853|SUPERIORITY||Least Squares Mean Difference|3.3|STANDARD_ERROR_OF_MEAN|1.05||0.002|TWO_SIDED|95.0|1.2|5.4||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||5.4|1.2|0.002
72490697|NCT02873936|144508853|SUPERIORITY||Least Squares Mean Difference|4.6|STANDARD_ERROR_OF_MEAN|1.28|<|0.001|TWO_SIDED|95.0|2.1|7.1||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||7.1|2.1|<0.001
72517032|NCT02528253|144564395|SUPERIORITY||LS Mean Difference|-0.27|STANDARD_ERROR_OF_MEAN|0.2||0.1751|TWO_SIDED|95.0|-0.66|0.12|||ANCOVA|||Change at Week 32: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference index, and baseline average LBPI as covariates, and study site as a random effect.||0.12|-0.66|0.1751
72490698|NCT02873936|144508853|SUPERIORITY||Least Squares Mean Difference|2.1|STANDARD_ERROR_OF_MEAN|1.3||0.11|TWO_SIDED|95.0|-0.5|4.7||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||4.7|-0.5|0.11
72490699|NCT02873936|144508856|SUPERIORITY||Least Squares Mean Difference|6.0|STANDARD_ERROR_OF_MEAN|2.5||0.009|TWO_SIDED|95.0|2.0|11.0||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||11.0|2.0|0.009
72490700|NCT02873936|144508856|SUPERIORITY||Least Squares Mean Difference|7.0|STANDARD_ERROR_OF_MEAN|2.5||0.003|TWO_SIDED|95.0|3.0|12.0||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||12.0|3.0|0.003
72517033|NCT02528253|144564395|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.2||0.3164|TWO_SIDED|95.0|-0.59|0.19|||ANCOVA|||Change at Week 40: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference index, and baseline average LBPI as covariates, and study site as a random effect.||0.19|-0.59|0.3164
72517034|NCT02528253|144564395|SUPERIORITY||LS Mean Difference|-0.24|STANDARD_ERROR_OF_MEAN|0.2||0.2253|TWO_SIDED|95.0|-0.62|0.15|||ANCOVA|||Change at Week 40: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference index, and baseline average LBPI as covariates, and study site as a random effect.||0.15|-0.62|0.2253
72568944|NCT00988065|144669070|SUPERIORITY_OR_OTHER||Difference in event rates|0.0||||||95.0|-2.5|2.5|||||95% confidence interval for the difference in event rates (treatment group minus placebo) according to Miettinen and Nurminen (Statistics in Medicine 1985; 4:213-226).|||2.5|-2.5|
72404783|NCT04206293|144317077|SUPERIORITY||LS Mean Difference|-1.42|STANDARD_ERROR_OF_MEAN|2.79||0.6192|TWO_SIDED|95.0|-7.48|4.64|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||Change from Baseline to Day 84||4.64|-7.48|0.6192
72404784|NCT04206293|144317078|SUPERIORITY||LS Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.08||0.8322|TWO_SIDED|95.0|-0.2|0.16|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||Change from Baseline to Day 28||0.16|-0.20|0.8322
72404785|NCT04206293|144317078|SUPERIORITY||LS Mean Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.07||0.1334|TWO_SIDED|95.0|-0.25|0.04|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||Change from Baseline to Day 84||0.04|-0.25|0.1334
72568945|NCT00988065|144669071|SUPERIORITY_OR_OTHER||Difference in event rates|2.0||||||95.0|-0.5|5.7|||||95% confidence interval for the difference in event rates (treatment group minus placebo) according to Miettinen and Nurminen (Statistics in Medicine 1985; 4:213-226).|Comparison of participants who had Level 1 or Level 2 diagnostic certainty.||5.7|-0.5|
72568946|NCT00988065|144669071|SUPERIORITY_OR_OTHER||Difference in event rates|0.0||||||95.0|-2.5|2.5|||||95% confidence interval for the difference in event rates (treatment group minus placebo) according to Miettinen and Nurminen (Statistics in Medicine 1985; 4:213-226).|Comparison of participants who had Level 1 or Level 2 diagnostic certainty.||2.5|-2.5|
72568947|NCT01229735|144669074|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.1|||=|0.7007|TWO_SIDED|95.0|0.7|1.7||P-value is from likelihood ratio test of treatment group regression coefficient against 0.|Regression, Logistic|||The Odds Ratio (OR) for LEV vs TPM is based on logistic regression modeling of subject retention by treatment and center pooling category. A profile likelihood confidence interval for the OR is presented.||1.7|0.7|=0.7007
72568948|NCT00985712|144669093|SUPERIORITY_OR_OTHER||LS Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.11||0.6692|TWO_SIDED|95.0|-0.17|0.26|||Mixed Models Analysis|The model details are given in the section of Measure Description.||Superiority criterion is met if the upper limit of Confidence Interval (CI) is below zero.||0.26|-0.17|0.6692
72568949|NCT00985712|144669094|SUPERIORITY_OR_OTHER|||||||0.3551||95.0||||P-value is for HbA1c ≤7.0%.|Chi-squared|||||||0.3551
72568950|NCT00985712|144669094|SUPERIORITY_OR_OTHER|||||||0.2026||95.0||||P-value is for HbA1c ≤7.5%.|Chi-squared|||||||0.2026
72568951|NCT00985712|144669095|SUPERIORITY_OR_OTHER|||||||0.907||95.0|||||ANCOVA|Analysis of covariance (ANCOVA) was adjusted for baseline values.||||||0.9070
72568952|NCT00985712|144669096|SUPERIORITY_OR_OTHER|||||||0.9817||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.9817
72568953|NCT00985712|144669097|SUPERIORITY_OR_OTHER|||||||0.1187||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.1187
72404786|NCT04206293|144317079|SUPERIORITY||LS Mean Difference|-5.09|STANDARD_ERROR_OF_MEAN|7.78||0.5221|TWO_SIDED|95.0|-21.56|11.38|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||Change from Baseline to Day 28||11.38|-21.56|0.5221
72404787|NCT04206293|144317079|SUPERIORITY||LS Mean Difference|6.74|STANDARD_ERROR_OF_MEAN|8.07||0.4174|TWO_SIDED|95.0|-10.55|24.03|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||Change from Baseline to Day 84||24.03|-10.55|0.4174
72404788|NCT04206293|144317080|SUPERIORITY||LS Mean Difference|2.77|STANDARD_ERROR_OF_MEAN|2.58||0.3052|TWO_SIDED|95.0|-2.9|8.44|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||Change from Baseline to Day 28||8.44|-2.90|0.3052
72568954|NCT00876018|144669103|OTHER|||||||0.004||95.0|||||Mann Whitney U test|||||||0.004
72568955|NCT00876018|144669103|OTHER|||||||0.147||95.0|||||Mann Whitney U test|||||||0.147
72568956|NCT00876018|144669104|OTHER|||||||0.002||95.0|||||Mann Whitney U test|||||||0.002
72568957|NCT00876018|144669104|OTHER|||||||0.003||95.0|||||Mann Whitney U test|||||||0.003
72568958|NCT00876018|144669105|OTHER|||||||0.153||95.0|||||Mann Whitney U test|||||||0.153
72568959|NCT00876018|144669105|OTHER|||||||0.903||95.0|||||Mann Whitney U test|||||||0.903
72568960|NCT00876018|144669106|OTHER|||||||0.143||95.0|||||Mann Whitney U test|||||||0.143
72568961|NCT00876018|144669106|OTHER|||||||0.678||95.0|||||Mann Whitney U test|||||||0.678
72568962|NCT01189500|144669129|SUPERIORITY_OR_OTHER||ratio of adjusted means|100.69|||||TWO_SIDED|90.0|96.7|104.85|||||Values have been back-transformed from the log scale.|DVS SR 100 mg + Tamoxifen 40 mg (test) versus Tamoxifen 40 mg (reference)||104.85|96.70|
72568963|NCT01189500|144669131|SUPERIORITY_OR_OTHER||ratio of adjusted means|99.44|||||TWO_SIDED|90.0|94.02|105.17|||||Values have been back-transformed from the log scale.|DVS SR 100 mg + Tamoxifen 40 mg (test) versus Tamoxifen 40 mg (reference)||105.17|94.02|
72568964|NCT01189500|144669136|SUPERIORITY_OR_OTHER||ratio of adjusted means|92.04|||||TWO_SIDED|90.0|84.71|100.0|||||Values have been back-transformed from the log scale.|DVS SR 100 mg + Tamoxifen 40 mg (test) versus Tamoxifen 40 mg (reference)||100.00|84.71|
72568965|NCT01189500|144669142|SUPERIORITY_OR_OTHER||ratio of adjusted means|112.07|||||TWO_SIDED|90.0|107.44|116.9|||||Values have been back-transformed from the log scale.|DVS SR 100 mg + Tamoxifen 40 mg (test) versus Tamoxifen 40 mg (reference)||116.90|107.44|
72568966|NCT01189500|144669147|SUPERIORITY_OR_OTHER||ratio of adjusted means|105.6|||||TWO_SIDED|90.0|99.74|111.81|||||Values have been back-transformed from the log scale.|DVS SR 100 mg + Tamoxifen 40 mg (test) versus Tamoxifen 40 mg (reference)||111.81|99.74|
72568967|NCT01189500|144669148|SUPERIORITY_OR_OTHER||ratio of adjusted means|108.47|||||TWO_SIDED|90.0|103.51|113.67|||||Values have been back-transformed from the log scale.|DVS SR 100 mg + Tamoxifen 40 mg (test) versus Tamoxifen 40 mg (reference)||113.67|103.51|
72568968|NCT03736213|144669170|SUPERIORITY||Mean Difference (Final Values)|0.54||||0.13|TWO_SIDED||||||paired t-test, two-tailed|df = 6|Ultrasound biofeedback treatment condition - visual-acoustic biofeedback treatment condition. Because more accurate productions have lower normalized acoustic values, a negative difference indicates an advantage for US biofeedback.|||||.13
72568969|NCT00321737|144669171|SUPERIORITY_OR_OTHER||||||<|1e-05||||||Hochberg's method was used to ensure that the overall 0.0025 level of significance was maintained for the pairwise comparisons between each dexlansoprazole MR dose and placebo.|Fisher Exact|||||||<0.00001
72568970|NCT00321737|144669171|SUPERIORITY_OR_OTHER||||||<|1e-05||||||Hochberg's method was used to ensure that the overall 0.0025 level of significance was maintained for the pairwise comparisons between each dexlansoprazole MR dose and placebo.|Fisher Exact|||||||<0.00001
72568971|NCT00321737|144669171|SUPERIORITY_OR_OTHER||||||>|0.99999||95.0||||Statistical significance was determined at the 0.0025 level without adjustment for multiple comparisons.|Fisher Exact|||||||>0.99999
72568972|NCT00321737|144669172|SUPERIORITY_OR_OTHER||||||<|1e-05||95.0||||The 0.0025 level of significance for this secondary endpoint was controlled using Hochberg's method for comparison of each dexlansoprazole MR dose to placebo.|Wilcoxon (Mann-Whitney)|||||||<0.00001
72568973|NCT00321737|144669172|SUPERIORITY_OR_OTHER||||||<|1e-05||95.0||||The 0.0025 level of significance for this secondary endpoint was controlled using Hochberg's method for comparison of each dexlansoprazole MR dose to placebo.|Wilcoxon (Mann-Whitney)|||||||<0.00001
72404789|NCT04206293|144317080|SUPERIORITY||LS Mean Difference|9.99|STANDARD_ERROR_OF_MEAN|2.57||0.0016|TWO_SIDED|95.0|4.48|15.5|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||Change from Baseline to Day 84||15.50|4.48|0.0016
72404790|NCT04206293|144317081|SUPERIORITY||LS Mean Difference|0.7|STANDARD_ERROR_OF_MEAN|0.48||0.1672|TWO_SIDED|95.0|-0.33|1.73|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||Change from Baseline to Day 28||1.73|-0.33|0.1672
72404791|NCT04206293|144317081|SUPERIORITY||LS Mean Difference|0.55|STANDARD_ERROR_OF_MEAN|0.29||0.0881|TWO_SIDED|95.0|-0.1|1.21|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||Change from Baseline to Day 84||1.21|-0.10|0.0881
72404792|NCT04206293|144317082|SUPERIORITY||LS Mean Difference|0.57|STANDARD_ERROR_OF_MEAN|0.28||0.0577|TWO_SIDED|95.0|-0.02|1.17|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||Change from Baseline to Day 28||1.17|-0.02|0.0577
72404793|NCT04206293|144317082|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.31||0.5224|TWO_SIDED|95.0|-0.85|0.45|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||Change from Baseline to Day 84||0.45|-0.85|0.5224
72404794|NCT04206293|144317083|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.2||0.2666|TWO_SIDED|95.0|-0.6|0.2|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||Change from Baseline to Day 28||0.2|-0.6|0.2666
72404795|NCT04206293|144317083|SUPERIORITY||LS Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|0.2||0.4366|TWO_SIDED|95.0|-0.3|0.7|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||Change from Baseline to Day 84||0.7|-0.3|0.4366
72490701|NCT02873936|144508856|SUPERIORITY||Least Squares Mean Difference|8.0|STANDARD_ERROR_OF_MEAN|2.6||0.003|TWO_SIDED|95.0|3.0|13.0||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||13.0|3.0|0.003
72490702|NCT02873936|144508856|SUPERIORITY||Least Squares Mean Difference|7.0|STANDARD_ERROR_OF_MEAN|2.6||0.006|TWO_SIDED|95.0|2.0|12.0||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||12.0|2.0|0.006
72490703|NCT02873936|144508856|SUPERIORITY||Least Squares Mean Difference|9.0|STANDARD_ERROR_OF_MEAN|2.9||0.002|TWO_SIDED|95.0|3.0|15.0||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||15.0|3.0|0.002
72490704|NCT02873936|144508856|SUPERIORITY||Least Squares Mean Difference|8.0|STANDARD_ERROR_OF_MEAN|2.9||0.007|TWO_SIDED|95.0|2.0|14.0||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||14.0|2.0|0.007
72490705|NCT03099187|144508903|SUPERIORITY||Difference in Group Means|-134.6||||0.6777|TWO_SIDED|95.0|-772.4|503.3||p-value was not adjusted for multiplicity and is provided for descriptive purpose only|t-test, 2 sided|||Primary Analysis in 2019. Mean FVC decline comparison between treatment groups using a Student's t-test with a two-sided significance level of 0.05||503.3|-772.4|0.6777
72517035|NCT02528253|144564395|SUPERIORITY||LS Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.2||0.3408|TWO_SIDED|95.0|-0.58|0.2|||ANCOVA|||Change at Week 48: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference index, and baseline average LBPI as covariates, and study site as a random effect.||0.20|-0.58|0.3408
72404796|NCT04206293|144317084|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.2||0.4197|TWO_SIDED|95.0|-0.6|0.3|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||a\*: Change from Baseline to Day 28||0.3|-0.6|0.4197
72404797|NCT04206293|144317084|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.3||0.914|TWO_SIDED|95.0|-0.6|0.5|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||a\*: Change from Baseline to Day 84||0.5|-0.6|0.9140
72404798|NCT04206293|144317084|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.2||0.7604|TWO_SIDED|95.0|-0.6|0.4|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||b\*: Change from Baseline to Day 28||0.4|-0.6|0.7604
72490706|NCT03099187|144508903|SUPERIORITY||Difference in Group Means|-216.0||||0.4682|TWO_SIDED|95.0|-803.6|371.7||p-value was not adjusted for multiplicity and is provided for descriptive purpose only|Student's t-test|||Final Analysis in 2020. Mean FVC decline comparison between treatment groups using a Student's t-test with a two-sided significance level of 0.05||371.7|-803.6|0.4682
72490707|NCT03099187|144508904|SUPERIORITY|||||||0.0383|||||||rank ANCOVA|||Primary Analysis in 2019||||0.0383
72490708|NCT03099187|144508904|SUPERIORITY|||||||0.0239|||||||rank ANCOVA|||Final Analysis in 2020||||0.0239
72568974|NCT00321737|144669172|SUPERIORITY_OR_OTHER|||||||0.0673||95.0||||Statistical significance was determined at 0.0025 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.06730
72517036|NCT02528253|144564395|SUPERIORITY||LS Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.2||0.3391|TWO_SIDED|95.0|-0.58|0.2|||ANCOVA|||Change at Week 48: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference index, and baseline average LBPI as covariates, and study site as a random effect.||0.20|-0.58|0.3391
72517037|NCT02528253|144564395|SUPERIORITY||LS Mean Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.2||0.5818|TWO_SIDED|95.0|-0.5|0.28|||ANCOVA|||Change at Week 56: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference index, and baseline average LBPI as covariates, and study site as a random effect.||0.28|-0.50|0.5818
72517038|NCT02528253|144564395|SUPERIORITY||LS Mean Difference|-0.23|STANDARD_ERROR_OF_MEAN|0.2||0.2562|TWO_SIDED|95.0|-0.62|0.16|||ANCOVA|||Change at Week 56: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference index, and baseline average LBPI as covariates, and study site as a random effect.||0.16|-0.62|0.2562
72517039|NCT02528253|144564397|SUPERIORITY||LS Mean Difference|-0.39|STANDARD_ERROR_OF_MEAN|0.16||0.0137|TWO_SIDED|95.0|-0.69|-0.08|||ANCOVA|||Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with general activity, and baseline average LBPI as covariates, and study site as a random effect.||-0.08|-0.69|0.0137
72517040|NCT02528253|144564397|SUPERIORITY||LS Mean Difference|-0.45|STANDARD_ERROR_OF_MEAN|0.16||0.0044|TWO_SIDED|95.0|-0.76|-0.14|||ANCOVA|||Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with general activity, and baseline average LBPI as covariates, and study site as a random effect.||-0.14|-0.76|0.0044
72517041|NCT02528253|144564397|SUPERIORITY||LS Mean Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.14||0.6194|TWO_SIDED|95.0|-0.35|0.21|||ANCOVA|||Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with general activity, and baseline average LBPI as covariates, and study site as a random effect.||0.21|-0.35|0.6194
72517042|NCT02528253|144564397|SUPERIORITY||LS Mean Difference|-0.31|STANDARD_ERROR_OF_MEAN|0.14||0.0271|TWO_SIDED|95.0|-0.59|-0.04|||ANCOVA|||Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with general activity, and baseline average LBPI as covariates, and study site as a random effect.||-0.04|-0.59|0.0271
72517043|NCT02528253|144564397|SUPERIORITY||LS Mean Difference|-0.38|STANDARD_ERROR_OF_MEAN|0.14||0.0085|TWO_SIDED|95.0|-0.66|-0.1|||ANCOVA|||Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with general activity, and baseline average LBPI as covariates, and study site as a random effect.||-0.10|-0.66|0.0085
72568975|NCT00321737|144669174|SUPERIORITY_OR_OTHER||||||<|1e-05||95.0||||Hochberg's method was used to ensure that the overall 0.0025 level of significance was maintained for the pairwise comparisons between each dexlansoprazole MR dose and placebo.|Log Rank|||||||<0.00001
72568976|NCT00321737|144669174|SUPERIORITY_OR_OTHER||||||<|1e-05||95.0||||Hochberg's method was used to ensure that the overall 0.0025 level of significance was maintained for the pairwise comparisons between each dexlansoprazole MR dose and placebo.|Log Rank|||||||<0.00001
72568977|NCT00321737|144669174|SUPERIORITY_OR_OTHER|||||||0.13932||95.0||||Statistical significance was determined at the 0.0025 level without adjustment for multiple comparisons.|Log Rank|||||||0.13932
72568978|NCT00321737|144669175|SUPERIORITY_OR_OTHER||||||<|1e-05||95.0||||The 0.0025 level of significance for this secondary endpoint was controlled using Hochberg's method for comparison of each dose to placebo.|Wilcoxon (Mann-Whitney)|||||||<0.00001
72568979|NCT00321737|144669175|SUPERIORITY_OR_OTHER||||||<|1e-05||95.0||||The 0.0025 level of significance for this secondary endpoint was controlled using Hochberg's method for comparison of each dose to placebo.|Wilcoxon (Mann-Whitney)|||||||<0.00001
72568980|NCT00321737|144669175|SUPERIORITY_OR_OTHER|||||||0.11257||95.0||||Statistical significance was determined at the 0.0025 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.11257
72568981|NCT01769339|144669179|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
72568982|NCT00290251|144669181|SUPERIORITY|||||||0.43|||||||t-test, 2 sided|performed on log-transformed delta change in total fibroid volume from baseline to end of treatment||||||0.43
72568983|NCT00290251|144669181|SUPERIORITY_OR_OTHER_LEGACY|||||||0.003|TWO_SIDED|95.0|||||ANOVA|Performed on log-transformed delta change||Ulipristal acetate groups one and two were first compared and found to be similar (see statistical analysis 1), so they were combined into a single treatment group for comparison to placebo group||||0.003
72568984|NCT00290251|144669182|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05|TWO_SIDED|95.0||||The Delta of scores from treatment end to baseline was used to compare by ANOVA.|ANOVA|Adjustment for age||No sample size calculation was made.||||< 0.05
72568985|NCT03188666|144669186|SUPERIORITY||Least Square Mean Difference|-24.6||||0.0741|TWO_SIDED|95.0|-51.8|2.5|||ANCOVA|||||2.5|-51.8|0.0741
72568986|NCT03188666|144669187|SUPERIORITY||Least Square Mean Difference|-24.9||||0.3726|TWO_SIDED|95.0|-80.8|30.9|||Mixed Model with Repeated Measure (MMRM)|||||30.9|-80.8|0.3726
72568987|NCT03188666|144669188|SUPERIORITY|||||||0.0039||||||Week 56 vs. Week 28|Wilcoxon signed rank test|||Compared number of new lesions per participant by CT at week 28 (relative to baseline) and week 56 (relative to week 28).||||0.0039
72404799|NCT04206293|144317084|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.4||0.5936|TWO_SIDED|95.0|-1.0|0.6|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||b\*: Change from Baseline to Day 84||0.6|-1.0|0.5936
72404800|NCT04206293|144317084|SUPERIORITY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.2||0.0808|TWO_SIDED|95.0|-0.9|0.1|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||L\*: Change from Baseline to Day 28||0.1|-0.9|0.0808
72404801|NCT04206293|144317084|SUPERIORITY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.3||0.1633|TWO_SIDED|95.0|-1.0|0.2|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||L\*: Change from Baseline to Day 84||0.2|-1.0|0.1633
72404802|NCT04206293|144317085|SUPERIORITY||LS Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.4||0.1977|TWO_SIDED|95.0|-1.6|0.4|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||Change from Baseline to Day 28||0.4|-1.6|0.1977
72404803|NCT04206293|144317085|SUPERIORITY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.9||0.7535|TWO_SIDED|95.0|-2.2|1.7|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||Change from Baseline to Day 84||1.7|-2.2|0.7535
72404804|NCT04206293|144317086|SUPERIORITY||LS Mean Difference|4.35|STANDARD_ERROR_OF_MEAN|3.95||0.2905|TWO_SIDED|95.0|-4.16|12.85|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||Change from Baseline to Day 28||12.85|-4.16|0.2905
72404805|NCT04206293|144317086|SUPERIORITY||LS Mean Difference|17.27|STANDARD_ERROR_OF_MEAN|6.37||0.0241|TWO_SIDED|95.0|2.84|31.69|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||Change from Baseline to Day 84||31.69|2.84|0.0241
72404806|NCT01454934|144317089|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.16||||0.1343|TWO_SIDED|95.0|0.95|1.41||P-value was calculated from a 2-sided long-rank test stratified by histology, TPC option, and geographic region.|Log Rank||Hazard Ratio was based on a Cox regression model including treatment as covariate, and histology, TPC option and geographic region as strata.|OS was compared between eribulin and TPC testing the following null hypothesis: H0: OS in Arm A (eribulin) is equal to OS in Arm B (TPC) against the alternative: H1: OS in Arm A (eribulin) is not equal to OS in Arm B (TPC).||1.41|0.95|0.1343
72404807|NCT01454934|144317090|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.09||||0.3946|TWO_SIDED|95.0|0.9|1.32||P-value was calculated from a 2-sided long-rank test stratified by histology, TPC option, and geographic region.|Log Rank||The hazard ratio was based on a Cox regression model including treatment as covariate, and histology, TPC option, and geographic region as strata.|OS was compared between eribulin and TPC testing the following null hypothesis: H0: OS in Arm A (eribulin) is equal to OS in Arm B (TPC) against the alternative: H1: OS in Arm A (eribulin) is not equal to OS in Arm B (TPC).||1.32|0.90|0.3946
72490709|NCT03099187|144508905|SUPERIORITY||Overall Mean Difference|95.3||||0.0018|TWO_SIDED|95.0|35.9|154.6||p-value was not adjusted for multiplicity and was provided for descriptive purpose only|Student's t-test|||Primary Analysis in 2019||154.6|35.9|0.0018
72490710|NCT03099187|144508905|SUPERIORITY||Overall Mean Difference|84.3||||0.0096|TWO_SIDED|95.0|20.7|147.8||p-value was not adjusted for multiplicity and was provided for descriptive purpose only|Student's t-test|||Final Analysis in 2020||147.8|20.7|0.0096
72490711|NCT03099187|144508906|SUPERIORITY||Odds Ratio (OR)|0.42||||0.0006|TWO_SIDED|95.0|0.25|0.69||p-value was not adjusted for multiplicity and was provided for descriptive purpose only|Cochran-Mantel-Haenszel|||Primary Analysis in 2019||0.69|0.25|0.0006
72490712|NCT03099187|144508906|SUPERIORITY||Odds Ratio (OR)|0.43||||0.0009|TWO_SIDED|95.0|0.26|0.71||p-value was not adjusted for multiplicity and was provided for descriptive purpose only|Cochran-Mantel-Haenszel|||Final Analysis in 2020||0.71|0.26|0.0009
72490713|NCT03099187|144508907|SUPERIORITY||Odds Ratio (OR)|0.44||||0.0114|TWO_SIDED|95.0|0.23|0.84||p-value was not adjusted for multiplicity and was provided for descriptive purpose only|Cochran-Mantel-Haenszel|||Primary Analysis in 2019||0.84|0.23|0.0114
72490714|NCT03099187|144508907|SUPERIORITY||Odds Ratio (OR)|0.46||||0.0168|TWO_SIDED|95.0|0.24|0.88||p-value was not adjusted for multiplicity and was provided for descriptive purpose only|Cochran-Mantel-Haenszel|||Final Analysis in 2020||0.88|0.24|0.0168
72490715|NCT03099187|144508908|SUPERIORITY|||||||0.0874||||||p-value was not adjusted for multiplicity and was provided for descriptive purpose only|rank ANCOVA|||Primary Analysis in 2019||||0.0874
72490716|NCT03099187|144508908|SUPERIORITY|||||||0.1191||||||p-values are not adjusted for multiplicity and are provided for descriptive purpose only.|rank ANCOVA|||Final Analysis in 2020||||0.1191
72490717|NCT03099187|144508909|SUPERIORITY|||||||0.0395||||||p-value was not adjusted for multiplicity and was provided for descriptive purpose only|rank ANCOVA|||Primary Analysis in 2019||||0.0395
72490718|NCT03099187|144508909|SUPERIORITY|||||||0.0299||||||p-value was not adjusted for multiplicity and was provided for descriptive purpose only|rank ANCOVA|||Final Analysis in 2020||||0.0299
72490719|NCT03099187|144508910|SUPERIORITY||Hodges-Lehmann Median Difference|0.0||||0.7788|TWO_SIDED|95.0|-5.0|5.0|||rank ANCOVA|Analysis of Covariance Changes from baseline to week 24 are compared between the treatment arms using a rank ANCOVA.||Primary Analysis in 2019||5.00|-5.00|0.7788
72490720|NCT03099187|144508910|SUPERIORITY||Hodges-Lehmann Median Difference|0.0||||0.8289|TWO_SIDED|95.0|-5.0|5.0||Analysis of Covariance Changes from baseline to week 24 or early discontinuation visit are compared between the treatment arms using a rank ANCOVA with change from baseline as outcome variable and standardized rank baseline value as covariate|rank ANCOVA|||Final Analysis in 2020||5.00|-5.00|0.8289
72490721|NCT03099187|144508911|SUPERIORITY||Hodges-Lehmann Median difference|0.29||||0.1872|TWO_SIDED|95.0|-0.45|1.04||p-value was not adjusted for multiplicity and was provided for descriptive purpose only|rank ANCOVA|Analysis of Covariance Changes from baseline to week 24 are compared between the treatment arms using a rank ANCOVA.||Primary Analysis in 2019||1.04|-0.45|0.1872
72568988|NCT03188666|144669189|SUPERIORITY||Least Square Mean Difference|-25.6||||0.0756|TWO_SIDED|95.0|-53.9|2.8|||ANCOVA|||||2.8|-53.9|0.0756
72568989|NCT03188666|144669190|SUPERIORITY||Least Square Mean Difference|-27.8||||0.3407|TWO_SIDED|95.0|-86.1|30.5|||Mixed Model with Repeated Measure (MMRM)|||||30.5|-86.1|0.3407
72568990|NCT03188666|144669191|SUPERIORITY||Least Square Mean Difference|-0.34||||0.2656|TWO_SIDED|95.0|-0.96|0.27|||ANCOVA|||||0.27|-0.96|0.2656
72568991|NCT03188666|144669192|SUPERIORITY||Least Square Mean Difference|-0.36||||0.2651|TWO_SIDED|95.0|-1.01|0.29|||ANCOVA|||||0.29|-1.01|0.2651
72568992|NCT03188666|144669199|SUPERIORITY|||||||0.0039||||||Week 56 vs. Week 28|Wilcoxon signed rank test|||Compared number of new lesions per participant by PET at week 28 (relative to baseline) and week 56 (relative to week 28).||||0.0039
72568993|NCT03188666|144669200|SUPERIORITY|||||||0.0027||||||Week 56 vs. Week 28|McNemar|||Compared percent of participants with new lesions by CT at week 28 (relative to baseline) and week 56 (relative to week 28).||||0.0027
72568994|NCT03188666|144669201|SUPERIORITY|||||||0.0047||||||Week 56 vs. Week 28|McNemar|||Compared percent of participants with new lesions by PET at week 28 (relative to baseline) and week 56 (relative to week 28).||||0.0047
72568995|NCT03188666|144669204|SUPERIORITY|||||||0.3663||||||Period 2 vs. Period 1|Wilcoxon signed rank test|||||||0.3663
72490722|NCT03099187|144508911|SUPERIORITY||Hodges-Lehmann Median Difference|0.27||||0.2019|TWO_SIDED|95.0|-0.48|1.02||Analysis of Covariance Changes from baseline to week 24 or early discontinuation visit are compared between the treatment arms using a rank ANCOVA with change from baseline as outcome variable and standardized rank baseline value as covariate.|rank ANCOVA|||Final Analysis in 2020||1.02|-0.48|0.2019
72490723|NCT03099187|144508912|SUPERIORITY||Hodges-Lehmann Median Difference|-2.0||||0.2995|TWO_SIDED|95.0|-10.0|4.0|||rank ANCOVA|Analysis of Covariance Changes from baseline to week 24 are compared between the treatment arms using a rank ANCOVA.||Primary Analysis in 2019||4.00|-10.00|0.2995
72490724|NCT03099187|144508912|SUPERIORITY||Hodges-Lehmann Median Difference|-2.0||||0.3372|TWO_SIDED|95.0|-10.0|4.0||Analysis of Covariance Changes from baseline to week 24 or early discontinuation visit are compared between the treatment arms using a rank ANCOVA with change from baseline as outcome variable and standardized rank baseline value as covariate.|rank ANCOVA|||Final Analysis in 2020||4.00|-10.00|0.3372
72490725|NCT03099187|144508913|SUPERIORITY||Hodges-Lehmann Median Difference|-1.86||||0.163|TWO_SIDED|95.0|-5.06|1.38|||rank ANCOVA|Analysis of Covariance Changes from baseline to week 24 are compared between the treatment arms using a rank ANCOVA.||Primary Analysis in 2019||1.38|-5.06|0.1630
72490726|NCT03099187|144508913|SUPERIORITY||Hodges-Lehmann Median Difference|-1.74||||0.1851|TWO_SIDED|95.0|-5.0|1.55||Analysis of Covariance Changes from baseline to week 24 or early discontinuation visit are compared between the treatment arms using a rank ANCOVA with change from baseline as outcome variable and standardized rank baseline value as covariate.|rank ANCOVA|||Final Analysis in 2020||1.55|-5.00|0.1851
72568996|NCT03188666|144669205|SUPERIORITY|||||||0.001||||||Period 2 vs. Period 1|Wilcoxon signed rank test|||||||0.0010
72568997|NCT03188666|144669211|SUPERIORITY|||||||0.0039||||||Week 56 vs. Week 28|Wilcoxon signed rank test|||Compared total new lesion volume per participant by CT at week 28 (relative to baseline) and week 56 (relative to week 28).||||0.0039
72568998|NCT03188666|144669212|SUPERIORITY|||||||0.0273||||||Week 56 vs. Week 28|Wilcoxon signed rank test|||Compared total lesion activity per participant in new lesions by PET at week 28 (relative to baseline) and week 56 (relative to week 28).||||0.0273
72568999|NCT03188666|144669213|SUPERIORITY|||||||0.2123||||||Period 2 vs. Period 1|Wilcoxon signed rank test|||||||0.2123
72569000|NCT03188666|144669214|SUPERIORITY|||||||0.1528||||||Period 2 vs. Period 1|Wilcoxon signed rank test|||||||0.1528
72569001|NCT03696953|144669227|OTHER|t test comparing||||||0.05|||||||t-test, 2 sided|||||||0.05
72569002|NCT03696953|144669228|OTHER|||||||0.73|||||||t-test, 2 sided|||||||0.73
72569003|NCT03696953|144669228|OTHER|T test||||||0.05|||||||t-test, 2 sided|||||||0.05
72569004|NCT03696953|144669229|OTHER|T test||||||0.01|||||||t-test, 2 sided|||Comparison of 36 week AP-GI-SA Scores between probiotic and placebo groups at 36 weeks||||0.01
72569005|NCT03696953|144669230|OTHER|T test||||||0.05|||||||t-test, 2 sided|||||||0.05
72569006|NCT03696953|144669231|OTHER|T test||||||0.05|||||||t-test, 2 sided|||||||0.05
72569007|NCT06204887|144669248|SUPERIORITY||||||<|0.05|||||||Kruskal-Wallis|||||||<0.05
72569008|NCT00807248|144669250|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.45|STANDARD_ERROR_OF_MEAN|0.96||0.6405|TWO_SIDED|95.0|-2.34|1.44|||ANCOVA|||||1.44|-2.34|0.6405
72569009|NCT00807248|144669250|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.47|STANDARD_ERROR_OF_MEAN|0.96||0.6227|TWO_SIDED|95.0|-1.41|2.35|||ANCOVA|||||2.35|-1.41|0.6227
72569010|NCT00807248|144669251|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.55|STANDARD_ERROR_OF_MEAN|1.24|<|0.0001|TWO_SIDED|95.0|-7.98|-3.11|||ANCOVA|||||-3.11|-7.98|<0.0001
72569011|NCT00807248|144669251|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.09|STANDARD_ERROR_OF_MEAN|1.24|<|0.0001|TWO_SIDED|95.0|-7.53|-2.66|||ANCOVA|||||-2.66|-7.53|<0.0001
72569012|NCT00807248|144669251|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.0|STANDARD_ERROR_OF_MEAN|1.24|<|0.0001|TWO_SIDED|95.0|-8.43|-3.56|||ANCOVA|||||-3.56|-8.43|<0.0001
72569013|NCT00807248|144669252|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.98|STANDARD_ERROR_OF_MEAN|1.09|<|0.0001|TWO_SIDED|95.0|-7.13|-2.84|||ANCOVA|||||-2.84|-7.13|<0.0001
72569014|NCT00807248|144669252|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.46|STANDARD_ERROR_OF_MEAN|1.09|<|0.0001|TWO_SIDED|95.0|-6.6|-2.32|||ANCOVA|||||-2.32|-6.60|<0.0001
72569015|NCT00807248|144669252|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.27|STANDARD_ERROR_OF_MEAN|1.09|<|0.0001|TWO_SIDED|95.0|-7.41|-3.13|||ANCOVA|||||-3.13|-7.41|<0.0001
72569016|NCT00807248|144669253|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.09|STANDARD_ERROR_OF_MEAN|0.77|<|0.0001|TWO_SIDED|95.0|-4.59|-1.58|||ANCOVA|||||-1.58|-4.59|<0.0001
72569017|NCT00807248|144669253|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.64|STANDARD_ERROR_OF_MEAN|0.77||0.0006|TWO_SIDED|95.0|-4.15|-1.14|||ANCOVA|||||-1.14|-4.15|0.0006
72569018|NCT00807248|144669253|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.61|STANDARD_ERROR_OF_MEAN|0.77|<|0.0001|TWO_SIDED|95.0|-5.13|-2.1|||ANCOVA|||||-2.10|-5.13|<0.0001
72490727|NCT03099187|144508914|SUPERIORITY||Hazard Ratio (HR)|1.22||||0.5922|TWO_SIDED|95.0|0.59|2.49|||Log Rank|Log-rank tests based on the time to the first event are to compare the two treatment arms.|Hazard ratios and corresponding 95% CI are calculated by applying Cox-proportional hazard models.|Primary Analysis in 2019. All-cause non-elective hospitalization.||2.49|0.59|0.5922
72490728|NCT03099187|144508914|SUPERIORITY||Hazard Ratio (HR)|0.86||||0.8057|TWO_SIDED|95.0|0.26|2.83|||Log Rank|Log-rank tests based on the time to the first event are to compare the two treatment arms.|Hazard ratios and corresponding 95% CI are calculated by applying Cox-proportional hazard models.|Primary Analysis in 2019. Respiratory non-elective hospitalization.||2.83|0.26|0.8057
72490729|NCT03099187|144508914|SUPERIORITY||Hazard Ratio (HR)|1.31||||0.4613|TWO_SIDED|95.0|0.63|2.73|||Log Rank|Log-rank tests based on the time to the first event are to compare the two treatment arms.|Hazard ratios and corresponding 95% CI are calculated by applying Cox-proportional hazard models|Final Analysis in 2020. All-cause non-elective hospitalization.||2.73|0.63|0.4613
72490730|NCT03099187|144508914|SUPERIORITY||Hazard Ratio (HR)|1.04||||0.9523|TWO_SIDED|95.0|0.3|3.59|||Log Rank|Log-rank tests based on the time to the first event are to compare the two treatment arms.|Hazard ratios and corresponding 95% CI are calculated by applying Cox-proportional hazard models.|Final Analysis in 2020. Respiratory non-elective hospitalization.||3.59|0.30|0.9523
72490731|NCT03099187|144508916|SUPERIORITY||Hazard Ratio (HR)|0.85||||0.7871|TWO_SIDED|95.0|0.26|2.78|||Log Rank|||||2.78|0.26|0.7871
72490732|NCT03099187|144508917|SUPERIORITY||Cox Proportional Hazard|0.84||||0.366|TWO_SIDED|95.0|0.56|1.24|||Log Rank|Log-rank tests based on the time to the first event are to compare the two treatment arms.||Primary Analysis in 2019||1.24|0.56|0.3660
72490733|NCT03099187|144508917|SUPERIORITY||Cox Proportional Hazard|0.85||||0.4173|TWO_SIDED|95.0|0.57|1.26|||Log Rank|Log-rank tests based on the time to the first event are to compare the two treatment arms.||Final Analysis in 2020||1.26|0.57|0.4173
72490734|NCT03099187|144508918|SUPERIORITY||Cox Proportional Hazard|0.79||||0.2726|TWO_SIDED|95.0|0.52|1.2|||Log Rank|Log-rank tests based on the time to the first event are to compare the two treatment arms.||Primary Analysis in 2019||1.20|0.52|0.2726
72490735|NCT03099187|144508918|SUPERIORITY||Cox Proportional Hazard|0.82||||0.3386|TWO_SIDED|95.0|0.54|1.24|||Log Rank|Log-rank tests based on the time to the first event are to compare the two treatment arms.||Final Analysis in 2020||1.24|0.54|0.3386
72490736|NCT03099187|144508919|SUPERIORITY||Cox Proportional Hazard|1.01||||0.9969|TWO_SIDED|95.0|0.06|16.08|||Log Rank|Log-rank tests based on the time to the first event are to compare the two treatment arms.||||16.08|0.06|0.9969
72490737|NCT03099187|144508920|SUPERIORITY|||||||0.3231|||||||Log Rank|Log-rank tests based on the time to the first event are to compare the two treatment arms.||||||0.3231
72490738|NCT00102960|144508955|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.59||||0.02|TWO_SIDED|95.0|0.38|0.93|||Regression, Cox|||Statistical analysis compares early therapy 40 weeks (ART-40W) relative to deferred therapy (ART-Def)||0.93|0.38|0.02
72490739|NCT00102960|144508955|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.47||||0.002|TWO_SIDED|95.0|0.27|0.76|||Regression, Cox|||Statistical analysis compares early therapy 96 weeks (ART-96W) relative to deferred therapy (ART-Def)||0.76|0.27|0.002
72490740|NCT00102960|144508960|SUPERIORITY_OR_OTHER_LEGACY||Kaplan-Meier Cummulative Probability|0.13||||0.03|TWO_SIDED|95.0|0.01|0.25|||Proportion test|||Relative to ART-Def, ART-40W had a 13% difference in the cumulative probability of clinical disease progression or death at 3·5 years||0.25|0.01|0.03
72490741|NCT00102960|144508960|SUPERIORITY||Kaplan-Meier Cummulative Probability|0.2||||0.0006|TWO_SIDED|95.0|0.09|0.31|||Proportion test|||Relative to ART-Def, ART-96W had a 13% difference in the cumulative probability of clinical disease progression or death at 3·5 years||0.31|0.09|0.0006
72490742|NCT00102960|144508961|SUPERIORITY_OR_OTHER_LEGACY||Rate per 100 person years|0.0|||<|0.0001|TWO_SIDED|||||This p-value compares event rates per 100 person-years across the three arms|Poisson Regression|||The CHER study compared Grade 3 or 4 clinical event rates per 100 person-years between the three arms using Poisson regression modeling over the study duration of 4.8 years.|The rates per 100 person-years were 33.8 (Arm 1), 21.6 (Arm 2) and 16 (Arm 3)|||<0.0001
72490743|NCT00102960|144508962|SUPERIORITY||Rate per 100 person years|0.0||||0.46|TWO_SIDED||||||Poisson regression|||The event rates per 100 person years were compared across the three arms|The laboratory events per 100 person years across the three arms were: 7 (Deferred arm), 8.1 (early therapy for 40 weeks) and 6 (early therapy for 96 weeks).|||0.46
72490744|NCT00102960|144508965|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.48||||0.011|TWO_SIDED|95.0|0.27|0.84|||Regression, Cox||Hazard rate reported above compares early therapy 40 weeks relative to the deferred therapy arm.|The analysis compares ART-40W relative to the ART-Def arm.||0.84|0.27|0.011
72490745|NCT00102960|144508965|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.34||||0.0009|TWO_SIDED|95.0|0.18|0.64|||Regression, Cox||The hazard ratio compares ART-96W relative to the ART-Def arm.|The analysis compares ART-96 Weeks relative to ART-Deferred||0.64|0.18|0.0009
72490746|NCT00102960|144508967|SUPERIORITY||Count of days|0.0||||0.004|TWO_SIDED|||||The p-value here compares the days spent in hospital across the three arms|Poisson regression||||The total number of days/count of days: 1018 (Arm 1), 533 (Arm 2) and 414 (Arm 3) were compared across the three groups by Poisson regression analysis.|||0.004
72490747|NCT00102960|144508968|SUPERIORITY||Hazard Ratio (HR)|0.562||||0.0021|TWO_SIDED|95.0|0.389|0.811|||Regression, Cox|||||0.811|0.389|0.0021
72490748|NCT00102960|144508968|SUPERIORITY||Hazard Ratio (HR)|0.583||||0.0038|TWO_SIDED|95.0|0.405|0.84|||Regression, Cox|||||0.840|0.405|0.0038
72490749|NCT02104583|144509028|SUPERIORITY||Eleclazine : Placebo Incident Rate Ratio|1.52||||0.152|TWO_SIDED|95.0|0.86|2.71|||generalized linear model|||The primary analysis of overall occurrence of appropriate ICD interventions through Week 24 was performed using a generalized linear model assuming a negative binomial distribution and log link. This model included terms for treatment, implanted device (ICD or CRT-D) and region \[US or rest of world (ROW)\].||2.71|0.86|0.152
72490750|NCT02104583|144509028|SUPERIORITY||Eleclazine : Placebo Incident Rate Ratio|0.82||||0.662|TWO_SIDED|95.0|0.34|1.97|||generalized linear model|||The primary analysis of overall occurrence of appropriate ICD interventions through Week 24 was performed using a generalized linear model assuming a negative binomial distribution and log link. This model included terms for treatment, implanted device (ICD or CRT-D) and region \[US or ROW\].||1.97|0.34|0.662
72490751|NCT02104583|144509028|SUPERIORITY||Eleclazine : Placebo Incident Rate Ratio|1.24||||0.618|TWO_SIDED|95.0|0.54|2.86|||generalized linear model|||The primary analysis of overall occurrence of appropriate ICD interventions through Week 24 was performed using a generalized linear model assuming a negative binomial distribution and log link. This model included terms for treatment, implanted device (ICD or CRT-D) and region \[US or ROW.||2.86|0.54|0.618
72490752|NCT00847912|144509121|SUPERIORITY_OR_OTHER_LEGACY|||||||0.93|||||||Log Rank|||||||0.93
72490753|NCT00847912|144509122|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.01||||0.93|TWO_SIDED|95.0|0.82|1.24|||Regression, Cox|||||1.24|0.82|0.93
72490754|NCT01732796|144509123|SUPERIORITY_OR_OTHER||Adjusted response rate|81.4|||<|0.0001|TWO_SIDED|95.0|76.6|86.2|||Stratified one sample z-test||Adjusted response rate will tested against 71%. It is calculated as a weighted average (non-cirrhotic: 89% times response rate+ cirrhotic: 11% times response rate), 11% is the highest rate of cirrhotic from historical trials with approved DAA+PegIFN|The proportion of patients achieving SVR12 was compared to an acceptable minimum SVR rate achieved with an approved direct acting anti-viral (DAA) in combination with pegylated interferon-alfa (PegIFN) from historical data. The acceptable minimum SVR rate was 71% (reference for PegIFN-eligible).||86.2|76.6|<0.0001
72490755|NCT01732796|144509123|SUPERIORITY_OR_OTHER||Adjusted response rate|71.7||||0.3989|TWO_SIDED|95.0|66.1|77.4|||Stratified one sample z-test||Adjusted response rate will tested against 71%. It is calculated as a weighted average (non-cirrhotic: 89% times response rate+ cirrhotic: 11% times response rate), 11% is the highest rate of cirrhotic from historical trials with approved DAA+PegIFN|The proportion of patients achieving SVR12 was compared to an acceptable minimum SVR rate achieved with an approved direct acting anti-viral (DAA) in combination with pegylated interferon-alfa (PegIFN) from historical data. The acceptable minimum SVR rate was 71% (reference for PegIFN-eligible).||77.4|66.1|0.3989
72404808|NCT01454934|144317091|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3034||||||The P-value was stratified by histology, TPC option, and geographic region.|Cochran-Mantel-Haenszel|||OS was compared between eribulin and TPC testing the following null hypothesis: H0: OS in Arm A (eribulin) is equal to OS in Arm B (TPC) against the alternative: H1: OS in Arm A (eribulin) is not equal to OS in Arm B (TPC).||||0.3034
72490756|NCT01732796|144509124|SUPERIORITY_OR_OTHER||Koch's method with continuity correction|10.8||||0.004|TWO_SIDED|95.0|2.8|18.8|||z-test|based on two sample z-test with continuity correction for variance.||||18.8|2.8|0.0040
72490757|NCT01732796|144509125|SUPERIORITY_OR_OTHER||Koch's method with continuity correction|6.0||||0.0575|TWO_SIDED|95.0|-1.5|13.5|||z-test|based on two sample z-test with continuity correction for variance.||Category: Percentage of patient with response||13.5|-1.5|0.0575
72490758|NCT01732796|144509126|SUPERIORITY_OR_OTHER||Koch's method with continuity correction|9.9||||0.0089|TWO_SIDED|95.0|1.7|18.1|||z-test|based on two sample z-test with continuity correction for variance.||Category: Percentage of patient with response||18.1|1.7|0.0089
72490759|NCT01757678|144509129|OTHER||Difference in Probability|0.14|||||TWO_SIDED|95.0|0.09|0.19||||||||.19|.09|
72490760|NCT01757678|144509130|OTHER||Difference in Probability|0.09|||||TWO_SIDED|95.0|0.04|0.14||||||||.14|.04|
72490761|NCT03972969|144509135|SUPERIORITY||Incidence Rate Ratio|0.13|||<|0.05|TWO_SIDED|95.0|0.05|0.32|||negative binomial regression|||||0.32|0.05|<0.05
72490762|NCT03972969|144509135|SUPERIORITY||Incidence Rate Ratio|0.25|||<|0.05|TWO_SIDED|95.0|0.1|0.61|||negative binomial regression|||||0.61|0.10|<0.05
72490763|NCT03972969|144509135|SUPERIORITY||Incidence Rate Ratio|0.52|||<|0.05|TWO_SIDED|95.0|0.19|1.38|||negative binomial regression|||||1.38|0.19|<0.05
72517044|NCT02528253|144564397|SUPERIORITY||LS Mean Difference|-0.53|STANDARD_ERROR_OF_MEAN|0.18||0.0027|TWO_SIDED|95.0|-0.87|-0.18|||ANCOVA|||Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with general activity, and baseline average LBPI as covariates, and study site as a random effect.||-0.18|-0.87|0.0027
72517045|NCT02528253|144564397|SUPERIORITY||LS Mean Difference|-0.78|STANDARD_ERROR_OF_MEAN|0.18|<|0.0001|TWO_SIDED|95.0|-1.13|-0.44|||ANCOVA|||Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with general activity, and baseline average LBPI as covariates, and study site as a random effect.||-0.44|-1.13|<.0001
72404809|NCT00430092|144317099|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Mantel Haenszel|||||||<0.0001
72490764|NCT03972969|144509136|SUPERIORITY||Incidence Rate Ratio|0.15|||<|0.05|TWO_SIDED|95.0|0.07|0.33|||negative binomial regression|||||0.33|0.07|<0.05
72490765|NCT03972969|144509136|SUPERIORITY||Incidence Rate Ratio|0.26|||<|0.05|TWO_SIDED|95.0|0.11|0.58|||negative binomial regression|||||0.58|0.11|<0.05
72490766|NCT03972969|144509136|SUPERIORITY||Incidence Rate Ratio|0.58|||<|0.05|TWO_SIDED|95.0|0.25|1.38|||negative binomial regression|||||1.38|0.25|<0.05
72490767|NCT01074190|144509140|SUPERIORITY|||||||0.34|||||||Chi-squared|||||||.34
72490768|NCT01074190|144509141|SUPERIORITY|||||||0.1|||||||Chi-squared|||||||.1
72490769|NCT01074190|144509142|SUPERIORITY|||||||0.1|||||||Chi-squared|||A sample size of 315 achieves 80% power to detect a difference among groups using a 2 degrees of freedom Chi-Square Test with a significance level (alpha) of 0.05.||||.1
72490770|NCT01500278|144509151|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.9|||=|0.467|TWO_SIDED|95.0|0.67|1.2||The odds ratio, CI, and p-value are from a logistic regression model with RTG, gender, Baseline duration of RA (\<2 years or \>=2 years), and geographic region as factors and age as a covariate.|Regression, Logistic|||||1.20|0.67|=0.467
72490771|NCT01500278|144509152|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.09|||=|0.532|TWO_SIDED|95.0|0.82|1.45||The odds ratio, CI and p-value are from a logistic regression model with RTG, gender, Baseline duration of RA (\<2 years or \>=2 years), and geographic region as factors and Baseline DAS28(ESR) and age as covariates.|Regression, Logistic|||||1.45|0.82|=0.532
72490772|NCT02459795|144509160|EQUIVALENCE|provides 85% power of success|Equivalence ratio|1.0|||||TWO_SIDED|90.0|-7.0|12.92|||Yates correction|||||12.92|-7.00|
72490773|NCT01297270|144509178|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|20.7|||<|0.0001|TWO_SIDED|95.0|10.7|30.6|||Cochran-Mantel-Haenszel||Estimate adjusted for genotype and race using Koch's method, with continuity correction|||30.6|10.7|<0.0001
72490774|NCT01297270|144509178|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|17.4||||0.0007|TWO_SIDED|95.0|7.3|27.4|||Cochran-Mantel-Haenszel||Estimate adjusted for genotype and race using Koch's method, with continuity correction|||27.4|7.3|0.0007
72490775|NCT01297270|144509179|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|20.7|||<|0.0001|TWO_SIDED|95.0|10.7|30.6|||Cochran-Mantel-Haenszel||Estimate adjusted for genotype and race using Koch's method, with continuity correction|||30.6|10.7|<0.0001
72490776|NCT01297270|144509179|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.6||||0.0014|TWO_SIDED|95.0|6.5|26.7|||Cochran-Mantel-Haenszel||Estimate adjusted for genotype and race using Koch's method, with continuity correction|||26.7|6.5|0.0014
72517046|NCT02528253|144564397|SUPERIORITY||LS Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.16||0.1859|TWO_SIDED|95.0|-0.54|0.1|||ANCOVA|||Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with general activity, and baseline average LBPI as covariates, and study site as a random effect.||0.10|-0.54|0.1859
72404810|NCT00782210|144317102|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.172|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.135|0.209|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.209|0.135|<0.0001
72404811|NCT00782210|144317102|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.176|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.139|0.214|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.214|0.139|<0.0001
72517047|NCT02528253|144564397|SUPERIORITY||LS Mean Difference|-0.31|STANDARD_ERROR_OF_MEAN|0.16||0.0573|TWO_SIDED|95.0|-0.63|0.01|||ANCOVA|||Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with general activity, and baseline average LBPI as covariates, and study site as a random effect.||0.01|-0.63|0.0573
72517048|NCT02528253|144564397|SUPERIORITY||LS Mean Difference|-0.56|STANDARD_ERROR_OF_MEAN|0.16||0.0005|TWO_SIDED|95.0|-0.88|-0.25|||ANCOVA|||Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with general activity, and baseline average LBPI as covariates, and study site as a random effect.||-0.25|-0.88|0.0005
72517049|NCT02528253|144564397|SUPERIORITY||LS Mean Difference|-0.31|STANDARD_ERROR_OF_MEAN|0.18||0.0841|TWO_SIDED|95.0|-0.66|0.04|||ANCOVA|||Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with general activity, and baseline average LBPI as covariates, and study site as a random effect.||0.04|-0.66|0.0841
72404812|NCT00782210|144317103|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.091|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.054|0.128|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.128|0.054|<0.0001
72404813|NCT00782210|144317103|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.101|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.064|0.137|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.137|0.064|<0.0001
72404814|NCT00782210|144317104|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.173|STANDARD_ERROR_OF_MEAN|0.031|<|0.0001||95.0|0.113|0.233|||ANCOVA|Treatment, tiotropium stratum and baseline as fixed effects|Olo 5 mcg qd minus Placebo|||0.233|0.113|<0.0001
72404815|NCT00782210|144317104|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.169|STANDARD_ERROR_OF_MEAN|0.031|<|0.0001||95.0|0.108|0.229|||Mixed Models Analysis|Treatment, tiotropium stratum and baseline as fixed effects|Olo 10 mcg qd minus Placebo|||0.229|0.108|<0.0001
72404816|NCT00782210|144317105|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.165|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.128|0.201|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.201|0.128|<0.0001
72404817|NCT00782210|144317105|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.175|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.139|0.212|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.212|0.139|<0.0001
72404818|NCT00782210|144317106|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.181|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.144|0.217|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.217|0.144|<0.0001
72404819|NCT00782210|144317106|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.192|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.156|0.229|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.229|0.156|<0.0001
72404820|NCT00782210|144317107|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.17|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.133|0.207|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.207|0.133|<0.0001
72517050|NCT02528253|144564397|SUPERIORITY||LS Mean Difference|-0.49|STANDARD_ERROR_OF_MEAN|0.18||0.0074|TWO_SIDED|95.0|-0.85|-0.13|||ANCOVA|||Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with general activity, and baseline average LBPI as covariates, and study site as a random effect.||-0.13|-0.85|0.0074
72517051|NCT02528253|144564397|SUPERIORITY||LS Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.16||0.316|TWO_SIDED|95.0|-0.49|0.16|||ANCOVA|||Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with general activity, and baseline average LBPI as covariates, and study site as a random effect.||0.16|-0.49|0.3160
72517052|NCT02528253|144564397|SUPERIORITY||LS Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.17||0.3763|TWO_SIDED|95.0|-0.47|0.18|||ANCOVA|||Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with general activity, and baseline average LBPI as covariates, and study site as a random effect.||0.18|-0.47|0.3763
72517053|NCT02528253|144564397|SUPERIORITY||LS Mean Difference|-0.32|STANDARD_ERROR_OF_MEAN|0.17||0.0505|TWO_SIDED|95.0|-0.65|0.0|||ANCOVA|||Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with general activity, and baseline average LBPI as covariates, and study site as a random effect.||0.00|-0.65|0.0505
72490777|NCT03882970|144509191|NON_INFERIORITY|The study was powered for superiority in HbA1c. The sample size provided \>99% power to show noninferiority assuming a 0.3% NI boundary, 0.35% greater mean reduction in tirzepatide doses compared to insulin degludec, 1:1:1:1 randomization, a common SD of 1.1%, 1 sided significance level of 0.0125, and a dropout rate of 28%.|LS Mean Difference|-0.86|||<|0.001|TWO_SIDED|95.0|-1.0|-0.72|||Mixed Models Analysis|||||-0.72|-1.00|<0.001
72517054|NCT02528253|144564397|SUPERIORITY||LS Mean Difference|-0.49|STANDARD_ERROR_OF_MEAN|0.2||0.0118|TWO_SIDED|95.0|-0.88|-0.11|||ANCOVA|||Change at Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with general activity, and baseline average LBPI as covariates, and study site as a random effect.||-0.11|-0.88|0.0118
72517055|NCT02528253|144564397|SUPERIORITY||LS Mean Difference|-0.64|STANDARD_ERROR_OF_MEAN|0.2||0.0012|TWO_SIDED|95.0|-1.03|-0.25|||ANCOVA|||Change at Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with general activity, and baseline average LBPI as covariates, and study site as a random effect.||-0.25|-1.03|0.0012
72517056|NCT02528253|144564397|SUPERIORITY||LS Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.18||0.2966|TWO_SIDED|95.0|-0.54|0.17|||ANCOVA|||Change at Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with general activity, and baseline average LBPI as covariates, and study site as a random effect.||0.17|-0.54|0.2966
72517057|NCT02528253|144564397|SUPERIORITY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.18||0.0956|TWO_SIDED|95.0|-0.66|0.05|||ANCOVA|||Change at Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with general activity, and baseline average LBPI as covariates, and study site as a random effect.||0.05|-0.66|0.0956
72490778|NCT03882970|144509191|NON_INFERIORITY|The study was powered for superiority in HbA1c. The sample size provided \>99% power to show noninferiority assuming a 0.3% NI boundary, 0.35% greater mean reduction in tirzepatide doses compared to insulin degludec, 1:1:1:1 randomization, a common SD of 1.1%, 1 sided significance level of 0.0125, and a dropout rate of 28%.|LS Mean Difference|-1.04|||<|0.001|TWO_SIDED|95.0|-1.17|-0.9|||Mixed Models Analysis|||||-0.90|-1.17|<0.001
72490779|NCT03882970|144509192|NON_INFERIORITY|The study was powered for superiority in HbA1c. The sample size provided \>99% power to show noninferiority assuming a 0.3% NI boundary, 0.35% greater mean reduction in tirzepatide doses compared to insulin degludec, 1:1:1:1 randomization, a common SD of 1.1%, 1 sided significance level of 0.0125, and a dropout rate of 28%.|LS Mean Difference|-0.59|||<|0.001|TWO_SIDED|95.0|-0.73|-0.45|||Mixed Models Analysis|||||-0.45|-0.73|<0.001
72490780|NCT03882970|144509193|SUPERIORITY||LS Mean Difference|-9.8|||<|0.001|TWO_SIDED|95.0|-10.8|-8.8|||Mixed Models Analysis|||||-8.8|-10.8|<0.001
72490781|NCT03882970|144509193|SUPERIORITY||LS Mean Difference|-13.0|||<|0.001|TWO_SIDED|95.0|-14.0|-11.9|||Mixed Models Analysis|||||-11.9|-14.0|<0.001
72490782|NCT03882970|144509193|SUPERIORITY||LS Mean Difference|-15.2|||<|0.001|TWO_SIDED|95.0|-16.2|-14.2|||Mixed Models Analysis|||||-14.2|-16.2|<0.001
72490783|NCT03882970|144509194|SUPERIORITY||LS Mean Difference|7.5||||0.004|TWO_SIDED|95.0|2.4|12.5|||Mixed Models Analysis|||||12.5|2.4|0.004
72404821|NCT00782210|144317107|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.167|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.13|0.204|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.204|0.130|<0.0001
72490784|NCT03882970|144509194|SUPERIORITY||LS Mean Difference|0.8||||0.751|TWO_SIDED|95.0|-4.3|5.9|||Mixed Models Analysis|||||5.9|-4.3|0.751
72490785|NCT03882970|144509194|SUPERIORITY||LS Mean Difference|-3.6||||0.168|TWO_SIDED|95.0|-8.7|1.5|||Mixed Models Analysis|||||1.5|-8.7|0.168
72490786|NCT03882970|144509195|SUPERIORITY||Odds Ratio (OR)|3.45|||<|0.001|TWO_SIDED|95.0|2.38|5.01|||Regression, Logistic|||||5.01|2.38|<0.001
72490787|NCT03882970|144509195|SUPERIORITY||Odds Ratio (OR)|7.02|||<|0.001|TWO_SIDED|95.0|4.55|10.84|||Regression, Logistic|||||10.84|4.55|<0.001
72490788|NCT03882970|144509195|SUPERIORITY||Odds Ratio (OR)|10.79|||<|0.001|TWO_SIDED|95.0|6.65|17.48|||Regression, Logistic|||||17.48|6.65|<0.001
72490789|NCT03882970|144509197|SUPERIORITY||Odds Ratio (OR)|29.78|||<|0.001|TWO_SIDED|95.0|18.35|48.35|||Regression, Logistic|||||48.35|18.35|<0.001
72490790|NCT03882970|144509197|SUPERIORITY||Odds Ratio (OR)|79.88|||<|0.001|TWO_SIDED|95.0|47.56|134.17|||Regression, Logistic|||||134.17|47.56|<0.001
72490791|NCT03882970|144509197|SUPERIORITY||Odds Ratio (OR)|110.77|||<|0.001|TWO_SIDED|95.0|64.73|189.55|||Regression, Logistic|||||189.55|64.73|<0.001
72490792|NCT03882970|144509198|SUPERIORITY||LS Mean Difference|-0.26||||0.096|TWO_SIDED|95.0|-0.57|0.05|||ANCOVA|||Hyperglycemia||0.05|-0.57|0.096
72490793|NCT03882970|144509198|SUPERIORITY||LS Mean Difference|-0.25||||0.113|TWO_SIDED|95.0|-0.57|0.06|||ANCOVA|||Hyperglycemia||0.06|-0.57|0.113
72490794|NCT03882970|144509198|SUPERIORITY||LS Mean Difference|-0.47||||0.003|TWO_SIDED|95.0|-0.78|-0.16|||ANCOVA|||Hyperglycemia||-0.16|-0.78|0.003
72490795|NCT03882970|144509198|SUPERIORITY||LS Mean Difference|-0.41||||0.014|TWO_SIDED|95.0|-0.74|-0.08|||ANCOVA|||Hypoglycemia||-0.08|-0.74|0.014
72490796|NCT03882970|144509198|SUPERIORITY||LS Mean Difference|-0.18||||0.28|TWO_SIDED|95.0|-0.51|0.15|||ANCOVA|||Hypoglycemia||0.15|-0.51|0.280
72490797|NCT03882970|144509198|SUPERIORITY||LS Mean Difference|-0.26||||0.129|TWO_SIDED|95.0|-0.59|0.07|||ANCOVA|||Hypoglycemia||0.07|-0.59|0.129
72490798|NCT03882970|144509198|SUPERIORITY||LS Mean Difference|3.01|||<|0.001|TWO_SIDED|95.0|2.26|3.75|||ANCOVA|||Treatment Satisfaction Score||3.75|2.26|<0.001
72404822|NCT00782210|144317108|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.174|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.136|0.212|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.212|0.136|<0.0001
72490799|NCT03882970|144509198|SUPERIORITY||LS Mean Difference|2.9|||<|0.001|TWO_SIDED|95.0|2.15|3.65|||ANCOVA|||Treatment Satisfaction Score||3.65|2.15|<0.001
72490800|NCT03882970|144509198|SUPERIORITY||LS Mean Difference|2.99|||<|0.001|TWO_SIDED|95.0|2.24|3.74|||ANCOVA|||Treatment Satisfaction Score||3.74|2.24|<0.001
72490801|NCT02411539|144509227|SUPERIORITY|Assuming that a common standard deviation of change (measured as difference of log10 transformed HIV-1 RNA/DNA ratios) in both arms was 0.30, with a sample size of 36 evaluable participants (18 in each arm), the study had 88% power to detect an effect size of 0.30 log10 (2-fold) in change of cell-associated HIV-1 RNA/DNA from baseline to week 6 using a two-sided Wilcoxon rank sum test at 10% type I error rate assuming a normal distribution||||||0.16||||||Two-sided Wilcoxon rank sum test at 10% significance level. Not adjusted for multiple comparisons.|Wilcoxon (Mann-Whitney)|||The primary efficacy analysis compared the change in cell-associated HIV-1 RNA/DNA ratio (log-transformed) from baseline to week 6 between the two randomized arms, testing the null hypothesis of no difference in changes in cell-associated HIV-1 RNA/DNA ratio between the two arms using a Wilcoxon rank sum test at 10% significance level.||||0.16
72490802|NCT04474795|144509265|SUPERIORITY||||||<|0.0001|||||||Wilcoxon paired signed rank test|||Compared pre and post training scores||||<0.0001
72490803|NCT04474795|144509266|SUPERIORITY||||||<|0.0001|||||||Wilcoxon paired signed rank test|||Comparison of scores pre and post training in individuals who completed training modules||||<0.0001
72490804|NCT04474795|144509267|SUPERIORITY|||||||0.606|||||||Wilcoxon paired signed rank test|||Patient autonomy||||0.606
72490805|NCT04474795|144509267|SUPERIORITY|||||||0.003|||||||Wilcoxon paired signed rank test|||Value of tight control||||0.003
72490806|NCT04474795|144509267|SUPERIORITY|||||||0.475|||||||Wilcoxon paired signed rank test|||Need for Special Training||||0.475
72490807|NCT04474795|144509268|SUPERIORITY|||||||0.009|||||||Wilcoxon paired signed rank test|||||||0.009
72490808|NCT04041284|144509271|OTHER||LS mean difference|-2.2|STANDARD_ERROR_OF_MEAN|0.5|<|0.0001|TWO_SIDED|95.0|-3.16|-1.21|||ANCOVA|||||-1.21|-3.16|<0.0001
72490809|NCT04041284|144509272|OTHER||LS mean difference|-1.4|STANDARD_ERROR_OF_MEAN|0.61||0.0205|TWO_SIDED|95.0|-2.61|-0.22|||Mixed Models Analysis|||||-0.22|-2.61|0.0205
72490810|NCT04041284|144509273|OTHER||Odds Ratio (OR)|3.26|||<|0.0001|TWO_SIDED|95.0|1.89|5.62|||Regression, Logistic|||||5.62|1.89|<0.0001
72517058|NCT02528253|144564397|SUPERIORITY||LS Mean Difference|-0.45|STANDARD_ERROR_OF_MEAN|0.18||0.0117|TWO_SIDED|95.0|-0.81|-0.1|||ANCOVA|||Change at Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with general activity, and baseline average LBPI as covariates, and study site as a random effect.||-0.10|-0.81|0.0117
72517059|NCT02528253|144564397|SUPERIORITY||LS Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.2||0.3732|TWO_SIDED|95.0|-0.57|0.21|||ANCOVA|||Change at Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with general activity, and baseline average LBPI as covariates, and study site as a random effect.||0.21|-0.57|0.3732
72517060|NCT02528253|144564397|SUPERIORITY||LS Mean Difference|-0.26|STANDARD_ERROR_OF_MEAN|0.2||0.1922|TWO_SIDED|95.0|-0.66|0.13|||ANCOVA|||Change at Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with general activity, and baseline average LBPI as covariates, and study site as a random effect.||0.13|-0.66|0.1922
72490811|NCT04041284|144509274|OTHER||LS mean difference|11.3|STANDARD_ERROR_OF_MEAN|2.21|<|0.0001|TWO_SIDED|95.0|6.91|15.59|||Mixed Models Analysis||Restrictive score: Fremanezumab versus placebo|||15.59|6.91|<0.0001
72517061|NCT02528253|144564397|SUPERIORITY||LS Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.21||0.2986|TWO_SIDED|95.0|-0.63|0.19|||ANCOVA|||Change at Week 32: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with general activity, and baseline average LBPI as covariates, and study site as a random effect.||0.19|-0.63|0.2986
72490812|NCT04041284|144509274|OTHER||LS mean difference|9.9|STANDARD_ERROR_OF_MEAN|2.12|<|0.0001|TWO_SIDED|95.0|5.73|14.08|||Mixed Models Analysis||Preventive score: Fremanezumab versus placebo|||14.08|5.73|<0.0001
72490813|NCT04041284|144509275|OTHER||LS mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.11||0.0915|TWO_SIDED|95.0|-0.39|0.03|||Mixed Models Analysis||Change at Week 4: Fremanezumab versus Placebo|||0.03|-0.39|0.0915
72490814|NCT04041284|144509275|OTHER||LS mean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.11||0.0006|TWO_SIDED|95.0|-0.59|-0.16|||Mixed Models Analysis||Change at Week 8: Fremanezumab versus Placebo|||-0.16|-0.59|0.0006
72490815|NCT04041284|144509275|OTHER||LS mean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.12||0.003|TWO_SIDED|95.0|-0.58|-0.12|||Mixed Models Analysis||Change at Week 12: Fremanezumab versus Placebo|||-0.12|-0.58|0.0030
72490816|NCT04041284|144509276|OTHER||LS mean difference|-3.6|STANDARD_ERROR_OF_MEAN|0.81|<|0.0001|TWO_SIDED|95.0|-5.15|-1.96|||Mixed Models Analysis|||||-1.96|-5.15|<0.0001
72569019|NCT00807248|144669254|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.25|STANDARD_ERROR_OF_MEAN|0.31|<|0.0001|TWO_SIDED|95.0|-1.85|-0.64|||ANCOVA|||||-0.64|-1.85|<0.0001
72569020|NCT00807248|144669254|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.11|STANDARD_ERROR_OF_MEAN|0.31||0.0004|TWO_SIDED|95.0|-1.72|-0.5|||ANCOVA|||||-0.50|-1.72|0.0004
72490817|NCT00563186|144509285|SUPERIORITY_OR_OTHER|This statistical analysis applies to the overall VRE, CDI and MRSA infection and colonization events expressed as incidence density (per 1000 patient-days at risk).|Incidence Rate ratio|1.6|STANDARD_ERROR_OF_MEAN|0.57||0.18|TWO_SIDED|95.0|0.8|3.22|||Poisson||Numerator is novel ward and denominator is traditional ward.|"It was calculated that this study will require 9750 patient days of observation in the traditional design wards and 19,500 patient days of observation in the novel design ward to ensure 80% statistical power to detect a 60% difference in the rates of incident cases of selected HAIs and ARO colonizations (the primary outcome measure) with an α level of 0.05 assuming that incident cases in each unit follow Poisson distribution based on well established historic trends on these units"||3.22|0.80|0.18
72490818|NCT00563186|144509287|SUPERIORITY_OR_OTHER||Rate Ratio|1.929|STANDARD_ERROR_OF_MEAN|0.493||0.175|TWO_SIDED|95.0|0.76|4.9|||Large test for person-time analysis|||||4.9|0.76|0.175
72490819|NCT00135668|144509347|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-16.2|STANDARD_DEVIATION|16.16|<|0.001|TWO_SIDED|95.0|-18.44|-13.97|||t-test, 2 sided|Paired t-test used.||Paired t-test used to test the null hypothesis of no change in MAP from baseline.||-13.97|-18.44|<0.001
72490820|NCT00135668|144509347|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-11.0|STANDARD_DEVIATION|15.68|<|0.001|TWO_SIDED|95.0|-15.45|-6.55|||t-test, 2 sided|Paired t-test.||||-6.55|-15.45|<0.001
72490821|NCT00135668|144509347|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-17.0|STANDARD_DEVIATION|12.88|<|0.001|TWO_SIDED|95.0|-20.7|-13.3|||t-test, 2 sided|Paired t-test.||||-13.30|-20.70|<0.001
72490822|NCT00135668|144509347|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-20.0|STANDARD_DEVIATION|15.95|<|0.001|TWO_SIDED|95.0|-24.38|-15.58|||t-test, 2 sided|Paired t-test.||||-15.58|-24.38|<0.001
72490823|NCT00135668|144509347|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-16.6|STANDARD_DEVIATION|18.63|<|0.001|TWO_SIDED|95.0|-21.87|-11.39|||t-test, 2 sided|Paired t-test||||-11.39|-21.87|<0.001
72490824|NCT02943564|144509396|SUPERIORITY||Least Squares Mean Difference|0.1||||0.8862|TWO_SIDED|95.0|-1.5|1.73|||Mixed Model Repeated Measures (MMRM)|||||1.73|-1.50|0.8862
72490825|NCT02943564|144509396|SUPERIORITY||Least Squares Mean Difference|-0.5||||0.5772|TWO_SIDED|95.0|-2.07|1.16|||Mixed Model Repeated Measures (MMRM)|||||1.16|-2.07|0.5772
72490826|NCT02943564|144509397|SUPERIORITY||Least Squares Mean Difference|-0.1||||0.8967|TWO_SIDED|95.0|-1.48|1.29|||Mixed Model Repeated Measures (MMRM)|||||1.29|-1.48|0.8967
72490827|NCT02943564|144509397|SUPERIORITY||Least Squares Mean Difference|0.0||||0.9963|TWO_SIDED|95.0|-1.38|1.39|||Mixed Model Repeated Measures (MMRM)|||||1.39|-1.38|0.9963
72490828|NCT01225731|144509405|SUPERIORITY_OR_OTHER||% Difference in Response Rate|28.89||||0.001|TWO_SIDED|95.0|13.41|44.36|||Cochran-Mantel-Haenszel|Stratified by baseline weight (≤90 kg or \>90 kg) and prior use of biologics for psoriasis (Yes/No).||||44.36|13.41|0.001
72490829|NCT01225731|144509405|SUPERIORITY_OR_OTHER||% Difference in Response Rate|60.0|||<|0.001|TWO_SIDED|95.0|48.42|71.58|||Cochran-Mantel-Haenszel|Stratified by baseline weight (≤90 kg or \>90 kg) and prior use of biologics for psoriasis (Yes/No).||||71.58|48.42|<0.001
72490830|NCT01225731|144509405|SUPERIORITY_OR_OTHER||% Difference in Response Rate|61.85|||<|0.001|TWO_SIDED|95.0|50.33|73.37|||Cochran-Mantel-Haenszel|Stratified by baseline weight (≤90 kg or \>90 kg) and prior use of biologics for psoriasis (Yes/No).||||73.37|50.33|<0.001
72490831|NCT01225731|144509405|SUPERIORITY_OR_OTHER||% Difference in Response Rate|69.97|||<|0.001|TWO_SIDED|95.0|58.96|80.99|||Cochran-Mantel-Haenszel|Stratified by baseline weight (≤90 kg or \>90 kg) and prior use of biologics for psoriasis (Yes/No).||||80.99|58.96|<0.001
72490832|NCT01225731|144509406|SUPERIORITY_OR_OTHER||% Difference in Response Rate|19.37||||0.009|TWO_SIDED|95.0|5.15|33.58|||Cochran-Mantel-Haenszel|Stratified by baseline weight (≤90 kg or \>90 kg) and prior use of biologics for psoriasis (Yes/No).||||33.58|5.15|0.009
72490833|NCT01225731|144509406|SUPERIORITY_OR_OTHER||% Difference in Response Rate|54.44|||<|0.001|TWO_SIDED|95.0|42.63|66.26|||Cochran-Mantel-Haenszel|Stratified by baseline weight (≤90 kg or \>90 kg) and prior use of biologics for psoriasis (Yes/No).||||66.26|42.63|<0.001
72517062|NCT02528253|144564397|SUPERIORITY||LS Mean Difference|-0.24|STANDARD_ERROR_OF_MEAN|0.21||0.2584|TWO_SIDED|95.0|-0.65|0.17|||ANCOVA|||Change at Week 32: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with general activity, and baseline average LBPI as covariates, and study site as a random effect.||0.17|-0.65|0.2584
72517063|NCT02528253|144564397|SUPERIORITY||LS Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.22||0.5195|TWO_SIDED|95.0|-0.57|0.29|||ANCOVA|||Change at Week 40: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with general activity, and baseline average LBPI as covariates, and study site as a random effect.||0.29|-0.57|0.5195
72517064|NCT02528253|144564397|SUPERIORITY||LS Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.21||0.3752|TWO_SIDED|95.0|-0.6|0.22|||ANCOVA|||Change at Week 40: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with general activity, and baseline average LBPI as covariates, and study site as a random effect.||0.22|-0.60|0.3752
72490834|NCT01225731|144509406|SUPERIORITY_OR_OTHER||% Difference in Response Rate|56.23|||<|0.001|TWO_SIDED|95.0|44.43|68.03|||Cochran-Mantel-Haenszel|Stratified by baseline weight (≤90 kg or \>90 kg) and prior use of biologics for psoriasis (Yes/No).||||68.03|44.43|<0.001
72490835|NCT01225731|144509406|SUPERIORITY_OR_OTHER||% Difference in Response Rate|67.65|||<|0.001|TWO_SIDED|95.0|56.42|78.88|||Cochran-Mantel-Haenszel|Stratified by baseline weight (≤90 kg or \>90 kg) and prior use of biologics for psoriasis (Yes/No).||||78.88|56.42|<0.001
72490836|NCT01225731|144509407|SUPERIORITY_OR_OTHER||% Difference in Response Rate|31.11|||<|0.001|TWO_SIDED|95.0|16.22|46.0|||Cochran-Mantel-Haenszel|Stratified by baseline weight (≤90 kg or \>90 kg) and prior use of biologics for psoriasis (Yes/No).||||46.0|16.22|<0.001
72490837|NCT01225731|144509407|SUPERIORITY_OR_OTHER||% Difference in Response Rate|55.56|||<|0.001|TWO_SIDED|95.0|44.48|66.63|||Cochran-Mantel-Haenszel|Stratified by baseline weight (≤90 kg or \>90 kg) and prior use of biologics for psoriasis (Yes/No).||||66.63|44.48|<0.001
72490838|NCT01225731|144509407|SUPERIORITY_OR_OTHER||% Difference in Response Rate|59.58|||<|0.001|TWO_SIDED|95.0|48.6|70.55|||Cochran-Mantel-Haenszel|Stratified by baseline weight (≤90 kg or \>90 kg) and prior use of biologics for psoriasis (Yes/No).||||70.55|48.60|<0.001
72624616|NCT02303821|144778816|OTHER||||||||||||||||||The primary objective of this endpoint was to compare the percentage of participants achieving CR after the end of induction therapy in study 20140106 with the percentage of participants achieving CR in an external control arm selected from an observational study (Amgen 20180065). In the external control arm, 7.8% of B-Cell participants (95% confidence interval \[CI\]: 1.0%, 14.7%) achieved CR, with a treatment difference odds ratio of 2.04 (95% CI: 0.54, 7.66). For T-Cell participants, 9.1% (95% CI: 0.7%, 17.5%) achieved CR, with an odds ratio of 1.58 (95% CI: 0.47, 5.31).|||
72624617|NCT00071032|144778843|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.01|||||TWO_SIDED|95.0|0.84|1.22|||||Liberal Arm (numerator) compared to Restrictive Arm (denominator)|||1.22|0.84|
72517065|NCT02528253|144564397|SUPERIORITY||LS Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.22||0.5157|TWO_SIDED|95.0|-0.56|0.28|||ANCOVA|||Change at Week 48: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with general activity, and baseline average LBPI as covariates, and study site as a random effect.||0.28|-0.56|0.5157
72517066|NCT02528253|144564397|SUPERIORITY||LS Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.21||0.5065|TWO_SIDED|95.0|-0.56|0.28|||ANCOVA|||Change at Week 48: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with general activity, and baseline average LBPI as covariates, and study site as a random effect.||0.28|-0.56|0.5065
72517067|NCT02528253|144564397|SUPERIORITY||LS Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.21||0.8373|TWO_SIDED|95.0|-0.47|0.38|||ANCOVA|||Change at Week 56: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with general activity, and baseline average LBPI as covariates, and study site as a random effect.||0.38|-0.47|0.8373
72517068|NCT02528253|144564397|SUPERIORITY||LS Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.22||0.5146|TWO_SIDED|95.0|-0.56|0.28|||ANCOVA|||Change at Week 56: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with general activity, and baseline average LBPI as covariates, and study site as a random effect.||0.28|-0.56|0.5146
72517069|NCT02528253|144564399|SUPERIORITY||LS Mean Difference|-0.45|STANDARD_ERROR_OF_MEAN|0.16||0.0059|TWO_SIDED|95.0|-0.76|-0.13|||ANCOVA|||Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with walking ability, and baseline average LBPI as covariates, and study site as a random effect.||-0.13|-0.76|0.0059
72517070|NCT02528253|144564399|SUPERIORITY||LS Mean Difference|-0.61|STANDARD_ERROR_OF_MEAN|0.16||0.0002|TWO_SIDED|95.0|-0.93|-0.29|||ANCOVA|||Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with walking ability, and baseline average LBPI as covariates, and study site as a random effect.||-0.29|-0.93|0.0002
72517071|NCT02528253|144564399|SUPERIORITY||LS Mean Difference|-0.26|STANDARD_ERROR_OF_MEAN|0.15||0.0756|TWO_SIDED|95.0|-0.56|0.03|||ANCOVA|||Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with walking ability, and baseline average LBPI as covariates, and study site as a random effect.||0.03|-0.56|0.0756
72517072|NCT02528253|144564399|SUPERIORITY||LS Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.15||0.2197|TWO_SIDED|95.0|-0.47|0.11|||ANCOVA|||Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with walking ability, and baseline average LBPI as covariates, and study site as a random effect.||0.11|-0.47|0.2197
72517073|NCT02528253|144564399|SUPERIORITY||LS Mean Difference|-0.34|STANDARD_ERROR_OF_MEAN|0.15||0.0208|TWO_SIDED|95.0|-0.63|-0.05|||ANCOVA|||Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with walking ability, and baseline average LBPI as covariates, and study site as a random effect.||-0.05|-0.63|0.0208
72517074|NCT02528253|144564399|SUPERIORITY||LS Mean Difference|-0.56|STANDARD_ERROR_OF_MEAN|0.17||0.0013|TWO_SIDED|95.0|-0.91|-0.22|||ANCOVA|||Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with walking ability, and baseline average LBPI as covariates, and study site as a random effect.||-0.22|-0.91|0.0013
72517075|NCT02528253|144564399|SUPERIORITY||LS Mean Difference|-0.74|STANDARD_ERROR_OF_MEAN|0.18|<|0.0001|TWO_SIDED|95.0|-1.08|-0.39|||ANCOVA|||Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with walking ability, and baseline average LBPI as covariates, and study site as a random effect.||-0.39|-1.08|<.0001
72624618|NCT00071032|144778844|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|-0.9|||||TWO_SIDED|99.0|-3.3|1.6|||||Liberal Arm (numerator) compared to Restrictive Arm (denominator)|||1.6|-3.3|
72624619|NCT05078112|144778874|OTHER|||||||0.000393|||||||t-test, 2 sided|||||||0.000393
72624620|NCT04116489|144778880|SUPERIORITY|||||||0.5272|||||||Regression, Linear|||||||.5272
72624621|NCT04116489|144778881|SUPERIORITY|||||||0.1657|||||||Regression, Linear|||||||.1657
72624622|NCT04116489|144778882|SUPERIORITY|||||||0.2437|||||||Regression, Linear|||||||.2437
72624623|NCT04116489|144778883|OTHER|||||||0.0373|||||||Regression, Linear|||||||.0373
72404823|NCT00782210|144317108|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.161|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.123|0.199|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.199|0.123|<0.0001
72404824|NCT00782210|144317109|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.173|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.134|0.211|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.211|0.134|<0.0001
72404825|NCT00782210|144317109|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.169|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001||95.0|0.131|0.208|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.208|0.131|<0.0001
72404826|NCT00782210|144317110|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.095|STANDARD_ERROR_OF_MEAN|0.018|<|0.0001||95.0|0.059|0.131|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.131|0.059|<0.0001
72404827|NCT00782210|144317110|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.111|STANDARD_ERROR_OF_MEAN|0.018|<|0.0001||95.0|0.075|0.147|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.147|0.075|<0.0001
72490839|NCT01225731|144509407|SUPERIORITY_OR_OTHER||% Difference in Response Rate|72.2|||<|0.001|TWO_SIDED|95.0|62.02|82.37|||Cochran-Mantel-Haenszel|Stratified by baseline weight (≤90 kg or \>90 kg) and prior use of biologics for psoriasis (Yes/No).||||82.37|62.02|<0.001
72490840|NCT00577642|144509418|OTHER|single group|||||<|0.05|||||||t-test, 1 sided|||Paired t-tests were used to compare differences of NTX cytokine levels at study entry versus end-of-study.||||<0.05
72490841|NCT04341441|144509419|SUPERIORITY|Sample size was determined with one planned interim analysis when 50% of participants had completed their 8 weeks of treatment using an O'Brien-Fleming alpha spending method to ensure an overall type 1 error of 0.05. With a sample size of 900 per group and alpha = 0.0492, the power to detect a 32% reduction in COVID-19 disease rate (10% vs 6.8%) between the placebo and HCQ treated groups, determined at 87%. Study required 1000 per group with a total of 3000 patients to complete the trial.|Risk Ratio (RR)|0.32||||0.75|TWO_SIDED|||||P-value for the comparison between groups, including the non-randomized active comparator, was 0.75.|Mantel Haenszel||Low number of primary events precluded estimated value of risk ratio.|||||0.75
72490842|NCT03548935|144509451|SUPERIORITY||Treatment difference|-12.44|||<|0.0001|TWO_SIDED|95.0|-13.37|-11.51|||ANCOVA|||Treatment policy estimand||-11.51|-13.37|<.0001
72490843|NCT03548935|144509451|SUPERIORITY||Treatment difference|-14.42|||<|0.0001|TWO_SIDED|95.0|-15.29|-13.55|||ANCOVA|||Hypothetical estimand||-13.55|-15.29|<0.0001
72490844|NCT03548935|144509452|SUPERIORITY||Odds Ratio (OR)|11.22|||<|0.0001|TWO_SIDED|95.0|8.88|14.19|||Regression, Logistic|||Treatment policy estimand||14.19|8.88|<0.0001
72490845|NCT03548935|144509452|SUPERIORITY||Odds Ratio (OR)|37.03|||<|0.0001|TWO_SIDED|95.0|28.02|48.95|||Regression, Logistic|||Hypothetical estimand||48.95|28.02|<0.0001
72490846|NCT00440947|144509510|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority would be established between the two arms if the lower limit of the 2-sided 95% confidence interval (CI) on the difference in the percentage of participants with HIV-1 RNA \<50 c/mL at Week 84 was -12% or greater.|Risk Difference (RD)|5.4||||0.14|TWO_SIDED|95.0|-1.8|12.5|||Cochran-Mantel-Haenszel|p-value was obtained from Cochran-Mantel-Haenszel stratified by baseline HIV-1 RNA (\<100000/\>=100000)||||12.5|-1.8|0.140
72490847|NCT02017327|144509582|SUPERIORITY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
72490848|NCT02017327|144509582|SUPERIORITY|||||||0.0045|||||||Cochran-Mantel-Haenszel|||||||0.0045
72490849|NCT02813694|144509594|NON_INFERIORITY|non-inferiority margin= 10%|Treatment difference|0.1|||||TWO_SIDED|95.0|-4.4|4.5|||||Difference in percentage of Responders for ECR (Lefamulin - Moxifloxacin). Confidence interval computed using continuity-corrected Z-statistic|||4.5|-4.4|
72490850|NCT02813694|144509595|NON_INFERIORITY|non-inferiority margin = 10%|Treatment difference|-1.6|||||TWO_SIDED|95.0|-6.3|3.1|||||Difference in Percentage of Success for IACR at test of cure visit (Lefamulin - Moxifloxacin). CI computed via Miettinen-Nurminen method, adjusted for prior antibiotic use \[Y vs. N\] and PORT risk class \[III vs. IV/V\], using CMH stratum weights.|||3.1|-6.3|
72490851|NCT02813694|144509595|NON_INFERIORITY|non-inferiority margain = 10%|Treatment difference|-1.6|||||TWO_SIDED|95.0|-6.5|3.3|||||Difference in percentage of Success for IACR at test of cure visit. Confidence interval computed using a continuity-corrected Z-test.|||3.3|-6.5|
72490852|NCT02813694|144509596|NON_INFERIORITY|non-inferiority margain = 10%|Treatment difference|-3.9|||||TWO_SIDED|95.0|-8.2|0.5|||||Difference in percentage of success for IACR at test of cure visit (Lefamulin - Moxifloxacin). CI computed via Miettinen-Nurminen method, adjusted for prior antibiotic use \[Y vs. N\]; PORT risk class \[III vs. IV/V\], using CMH stratum weights.|||0.5|-8.2|
72490853|NCT02813694|144509596|NON_INFERIORITY|non-inferiority margin = 10%|Treatment difference|-3.9|||||TWO_SIDED|95.0|-8.4|0.7|||||Difference in Percentage of Success for IACR at test of cure visit (Lefamulin - Moxifloxacin). Confidence interval computed using continuity-corrected Z-statistic.|||0.7|-8.4|
72490854|NCT01265797|144509603|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.4||||0.3|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|The Mann-Whitney U test was used to compare outcome measures between two treatment groups in the run-in month minus blinded month||The a priori alpha level was set at p \< 0.05, and a power of 0.80 (80%) was used to compute the number of subjects needed to find a meaningful difference between the verum and sham groups. Assuming that 20% of persons with the sham device and 60% of persons with CES device will meet the primary end point of ≥50% decrease in the frequency of headache days over the course of the study, 27 subjects are enrolled per group.||||0.30
72490855|NCT01265797|144509604|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.09||||0.89|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|The Mann-Whitney U test was used to compare secondary outcome measures between two treatment groups in the run-in month minus open label month||||||0.89
72490856|NCT01265797|144509605|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.96||||0.3|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.30
72404828|NCT00782210|144317111|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.095|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.059|0.131|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.131|0.059|<0.0001
72490857|NCT01265797|144509606|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3||||0.98|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|The Mann-Whitney U test was used to compare the primary and secondary outcome measures between the two treatment groups.||The a priori alpha level was set at p \< 0.05, and beta 0.2. Assuming that 20% of persons with the sham device and 60% of persons with CES device will meet the primary end point of ≥50% decrease in the frequency of headache days over the course of the study, 27 subjects are enrolled per group. The null hypothesis: No difference in the depression score/14 day recall between the two groups.||||0.98
72490858|NCT01265797|144509607|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.91||||0.75|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.75
72490859|NCT01265797|144509608|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.6||||0.73|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.73
72490860|NCT01265797|144509609|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.74||||0.02|TWO_SIDED|||||Change in mean anxiety score/ 14 day recall from the blinded period to open label period|Wilcoxon (Mann-Whitney)|||||||0.02
72490861|NCT01265797|144509610|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.14||||0.98|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.98
72490862|NCT01265797|144509611|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.05||||0.97|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.97
72490863|NCT01265797|144509612|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.16||||0.87|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.87
72490864|NCT01265797|144509613|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.16||||0.83|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.83
72490865|NCT01265797|144509614|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.15||||0.92|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.92
72490866|NCT01087905|144509633|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.26||||0.076|TWO_SIDED|95.0|0.98|1.61|||Regression, Logistic|||"Null hypothesis: No difference in abstinence rates for participants receiving Two Weeks of Nicotine Replacement Therapy (NRT) versus Six Weeks of Nicotine Replacement Therapy (NRT). We hypothesized that Six Weeks of NRT would result in statistically significantly higher abstinence rates compared to Two Weeks of NRT.~The study was originally powered to detect at least a 6.4% increase in the abstinence rate due to an enhanced intervention (e.g., 6 wks NRT)."||1.61|0.98|.076
72490867|NCT01087905|144509633|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.36||||0.017|TWO_SIDED|95.0|1.06|1.75|||Regression, Logistic|||"Null hypothesis: No difference in abstinence rates for participants receiving NRT Monotherapy (Nicotine Patch Only) versus NRT Combination Therapy (Nicotine Patch plus Nicotine Gum). We hypothesized that Combination NRT would result in statistically significantly higher abstinence rates compared to NRT Monotherapy.~The study was originally powered to detect at least a 6.4% increase in the abstinence rate due to an enhanced intervention (e.g., Combination NRT)."||1.75|1.06|.017
72490868|NCT01087905|144509633|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.89||||0.343|TWO_SIDED|95.0|0.69|1.14|||Regression, Logistic|||"Null hypothesis: No difference in abstinence rates for participants receiving Standard Cessation Counseling (No CMAC) versus Standard Cessation Counseling plus CMAC. We hypothesized that Standard Counseling plus CMAC would result in statistically significantly higher abstinence rates compared to Standard Counseling Only.~The study was originally powered to detect at least a 6.4% increase in the abstinence rate due to an enhanced intervention (e.g., Standard Counseling plus CMAC)."||1.14|0.69|.343
72490869|NCT01087905|144509634|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.49||||0.029|TWO_SIDED|95.0|1.04|2.14|||Regression, Logistic||Inclusion of the Cognitive Medication Adherence Counseling (CMAC) factor (No CMAC versus CMAC) as a control variable did not change the results of this analysis.|"Null hypothesis: No difference in abstinence rates for participants receiving Two Weeks of Nicotine Replacement Therapy (NRT) Monotherapy (Nicotine Patch Only) versus Two Weeks of Combination NRT (Patch+Gum). We hypothesized that Two Weeks of Combination NRT would result in statistically significantly higher abstinence rates compared to Two Weeks of NRT Monotherapy.~The study was originally powered to detect at least a 6.4% increase in the abstinence rate due to an enhanced intervention."||2.14|1.04|.029
72490870|NCT01087905|144509634|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.38||||0.079|TWO_SIDED|95.0|0.96|1.97|||Regression, Logistic||Inclusion of the Cognitive Medication Adherence Counseling (CMAC) factor (No CMAC versus CMAC) as a control variable did not change the results of this analysis.|"Null hypothesis: No difference in abstinence rates for participants receiving Two Weeks of Nicotine Replacement Therapy (NRT) Monotherapy (Nicotine Patch Only) versus SIx Weeks of NRT Monotherapy. We hypothesized that Six Weeks of NRT Monotherapy would result in statistically significantly higher abstinence rates compared to Two Weeks of NRT Monotherapy.~The study was originally powered to detect at least a 6.4% increase in the abstinence rate due to an enhanced intervention."||1.97|0.96|.079
72490871|NCT01087905|144509634|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.71||||0.003|TWO_SIDED|95.0|1.2|2.45|||Regression, Logistic||Inclusion of the Cognitive Medication Adherence Counseling (CMAC) factor (No CMAC versus CMAC) as a control variable did not change the results of this analysis.|"Null hypothesis: No difference in abstinence rates for participants receiving Two Weeks of Nicotine Replacement Therapy (NRT) Monotherapy (Nicotine Patch Only) versus Six Weeks of Combination NRT (Patch+Gum). We hypothesized that Six Weeks of Combination NRT would result in statistically significantly higher abstinence rates compared to Two Weeks of NRT Monotherapy.~The study was originally powered to detect at least a 6.4% increase in the abstinence rate due to an enhanced intervention."||2.45|1.20|.003
72490872|NCT01087905|144509635|SUPERIORITY_OR_OTHER||incremental cost-effectiveness ratio|357.0||||||95.0||||There is no p-value for the incremental cost-effectiveness ratio (ICER).|Incremental cost-effectiveness ratio|Unit of measurement for ICER is U.S. dollars.||In this analysis, the incremental cost-effectiveness ratio (ICER) is computed. ICER is a measure of the added cost per added quit for two treatments. ICER was computed as the cost difference between the least intensive treatment group (2 weeks of nicotine patch only) and a more intensive comparison group divided by the difference in the quit rates of the two groups being compared; ICER for the group that received 2 weeks of nicotine patch and nicotine gum = (213-178)/(.482-.384) = $357.||||
72624624|NCT01969058|144778927|SUPERIORITY|||||||0.03||||||Not adjusted for multiple comparisons.|Wilcoxon (Mann-Whitney)|||Null hypothesis: There is no difference between the two arms in the change in T-cell activation from baseline to week 14/16.||||0.030
72624625|NCT01346592|144778951|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was established if the lower limit of the confidence interval of the day 50 ratio of GMTs was \>0.667|GMT ratio (H1N1 strain)|2.44|||||TWO_SIDED|97.6|2.06|2.9||||||||2.9|2.06|
72404829|NCT00782210|144317111|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.091|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.054|0.127|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.127|0.054|<0.0001
72490873|NCT01087905|144509635|SUPERIORITY_OR_OTHER||Incremental cost-effectiveness ratio|712.0||||||95.0||||There is no p-value for the incremental cost-effectiveness ratio (ICER).|Incremental cost-effectiveness ratio|Unit of measurement for ICER is U.S. dollars.||In this analysis, the incremental cost-effectiveness ratio (ICER) is computed. ICER is a measure of the added cost per added quit for two treatments. ICER was computed as the cost difference between the least intensive treatment group (2 weeks of nicotine patch only) and a more intensive comparison group divided by the difference in the quit rates of the two groups being compared; ICER for the group that received 6 weeks of nicotine patch only = (233-178)/(.462-.384) = $712.||||
72490874|NCT01087905|144509635|SUPERIORITY_OR_OTHER||Incremental cost-effectiveness ratio|1290.0||||||95.0||||There is no p-value for the incremental cost-effectiveness ratio (ICER).|Incremental cost-effectiveness ratio|Unit of measurement for ICER is U.S. dollars.||In this analysis, the Incremental cost-effectiveness ratio (ICER) is computed. ICER is a measure of the added cost per added quit for two treatments. ICER was computed as the cost difference between the least intensive treatment group (2 weeks of nicotine patch only) and a more intensive comparison group divided by the difference in the quit rates of the two groups being compared; ICER for the group that received 6 weeks of nicotine patch and nicotine gum = (348-178)/(.516-.384) = $1290.||||
72490875|NCT01179009|144509653|SUPERIORITY|||||||0.53||||||The p-value above represents the interaction between the treatment group and time.|ANOVA|||||||0.53
72490876|NCT01179009|144509654|SUPERIORITY|||||||0.06||||||The p-value above comes from a model where the treatment group is used to predict the CGI improvement score.|Ordinal regression|||||||0.06
72490877|NCT01556425|144509690|SUPERIORITY||Odds Ratio (OR)|2.26||||0.48|TWO_SIDED|95.0|0.2|21.6|||General Estimating Equation (GEE)|||||21.6|0.2|0.48
72490878|NCT01556425|144509690|SUPERIORITY||Odds Ratio (OR)|0.58||||0.61|TWO_SIDED|95.0|0.1|4.6|||General Estimating Equation (GEE)|||||4.6|0.1|0.61
72490879|NCT01556425|144509690|SUPERIORITY||Odds Ratio (OR)|6.0||||0.11|TWO_SIDED|95.0|0.7|54.9|||General Estimating Equation (GEE)|||||54.9|0.7|0.11
72490880|NCT01556425|144509690|SUPERIORITY||Odds Ratio (OR)|2.66||||0.39|TWO_SIDED|95.0|0.3|24.9|||General Estimating Equation (GEE)|||||24.9|0.3|0.39
72490881|NCT01556425|144509690|SUPERIORITY||Odds Ratio (OR)|10.4||||0.03|TWO_SIDED|95.0|1.3|85.5|||General Estimating Equation (GEE)|||||85.5|1.3|0.03
72490882|NCT01556425|144509691|SUPERIORITY||Odds Ratio (OR)|0.36||||0.3|TWO_SIDED|95.0|0.1|2.4|||General Estimating Equation (GEE)|||||2.4|0.1|0.30
72490883|NCT01556425|144509691|SUPERIORITY||Odds Ratio (OR)|0.2||||0.08|TWO_SIDED|95.0|0.03|1.2|||General Estimating Equation (GEE)|||||1.2|0.03|0.08
72490884|NCT01556425|144509691|SUPERIORITY||Odds Ratio (OR)|0.91||||0.91|TWO_SIDED|95.0|0.1|5.8|||General Estimating Equation (GEE)|||||5.8|0.1|0.91
72490885|NCT01556425|144509691|SUPERIORITY||Odds Ratio (OR)|2.47||||0.34|TWO_SIDED|95.0|0.4|15.8|||General Estimating Equation (GEE)|||||15.8|0.4|0.34
72490886|NCT01556425|144509691|SUPERIORITY||Odds Ratio (OR)|4.46||||0.09|TWO_SIDED|95.0|0.8|26.1|||General Estimating Equation (GEE)|||||26.1|0.8|0.09
72490887|NCT01505634|144509692|NON_INFERIORITY|Non-inferiority for the relebactam 250 mg + imipenem/cilastatin group versus the Placebo for relebactam + imipenem/cilastatin group was demonstrated if the lower bound of the 95% CI was not lower than the pre-specified non-inferiority margin of -15%.|Percent Difference|-3.1||||0.005|TWO_SIDED|95.0|-11.2|3.2|||Miettinen and Nurminen||Relebactam minus Placebo|Percent Difference (Diff) in Favorable MR||3.2|-11.2|0.005
72490888|NCT01505634|144509692|NON_INFERIORITY|Non-inferiority for the relebactam 125 mg + imipenem/cilastatin group versus the Placebo for relebactam + imipenem/cilastatin group was demonstrated if the lower bound of the 95% CI was not lower than the pre-specified non-inferiority margin of -15%.|Percent Difference|-0.1|||<|0.001|TWO_SIDED|95.0|-6.4|5.9|||Miettinen and Nurminen||Relebactam minus Placebo|Percent Diff in Favorable MR||5.9|-6.4|< 0.001
72490889|NCT01505634|144509693|OTHER|ECI #1 is a confirmed elevated AST or ALT ≥5X ULN. Inferential testing for statistical significance with p-values and 95% confidence intervals was performed to provide a comparison between the relebactam 250 mg + imipenem/cilastatin group versus the Placebo for relebactam + imipenem/cilastatin group.|Percent Difference|1.0||||0.315|TWO_SIDED|95.0|-2.7|5.5|||Miettinen and Nurminen||Relebactam minus Placebo|Percent Diff in Participants with Event of Clinical Interest (ECI) #1||5.5|-2.7|0.315
72490890|NCT01505634|144509693|OTHER|ECI #1 is a confirmed elevated AST or ALT ≥5X ULN. Inferential testing for statistical significance with p-values and 95% confidence intervals was performed to provide a comparison between the relebactam 125 mg + imipenem/cilastatin group versus the Placebo for relebactam + imipenem/cilastatin group.|Percent Difference|1.0||||0.315|TWO_SIDED|95.0|-2.7|5.5|||Miettinen and Nurminen||Relebactam minus Placebo|Percent Diff in Participants with ECI #1||5.5|-2.7|0.315
72624626|NCT01346592|144778951|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was established if the lower limit of the confidence interval of the day 50 ratio of GMTs was \>0.667|GMT ratio (H3N2 strain)|1.89|||||TWO_SIDED|97.6|1.69|2.1||||||||2.1|1.69|
72624627|NCT01346592|144778951|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was established if the lower limit of the confidence interval of the day 50 ratio of GMTs was \>0.667|GMT ratio (B strain)|3.07|||||TWO_SIDED|97.6|2.66|3.54||||||||3.54|2.66|
72624628|NCT01346592|144778951|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was established if the lower limit of the confidence interval of the day 50 ratio of GMTs was \>0.667|GMT ratio (H1N1 strain)|3.2|||||TWO_SIDED|97.6|2.7|3.8||||||||3.8|2.7|
72624629|NCT01346592|144778951|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was established if the lower limit of the confidence interval of the day 50 ratio of GMTs was \>0.667|GMT ratio (H3N2 strain)|2.38|||||TWO_SIDED|97.6|2.14|2.65||||||||2.65|2.14|
72490891|NCT01505634|144509694|OTHER|Event of Clinical Interest (ECI) #2 is elevated AST or ALT ≥3X ULN, elevated total bilirubin ≥2X ULN, and with an ALP \<2X ULN. Inferential testing for statistical significance with p-values and 95% confidence intervals was performed to provide a comparison between the relebactam 250 mg + imipenem/cilastatin group versus the Placebo for relebactam + imipenem/cilastatin group.|Percent Difference|0.0|||>|0.999|TWO_SIDED|95.0|-3.7|3.8||No participants met the criteria for ECI #2.|Miettinen and Nurminen||Relebactam minus Placebo|Percent Diff Participants with ECI #2||3.8|-3.7|> 0.999
72517076|NCT02528253|144564399|SUPERIORITY||LS Mean Difference|-0.21|STANDARD_ERROR_OF_MEAN|0.16||0.1873|TWO_SIDED|95.0|-0.53|0.1|||ANCOVA|||Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with walking ability, and baseline average LBPI as covariates, and study site as a random effect.||0.10|-0.53|0.1873
72517077|NCT02528253|144564399|SUPERIORITY||LS Mean Difference|-0.35|STANDARD_ERROR_OF_MEAN|0.16||0.0305|TWO_SIDED|95.0|-0.66|-0.03|||ANCOVA|||Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with walking ability, and baseline average LBPI as covariates, and study site as a random effect.||-0.03|-0.66|0.0305
72517078|NCT02528253|144564399|SUPERIORITY||LS Mean Difference|-0.52|STANDARD_ERROR_OF_MEAN|0.16||0.0013|TWO_SIDED|95.0|-0.84|-0.2|||ANCOVA|||Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with walking ability, and baseline average LBPI as covariates, and study site as a random effect.||-0.20|-0.84|0.0013
72517079|NCT02528253|144564399|SUPERIORITY||LS Mean Difference|-0.43|STANDARD_ERROR_OF_MEAN|0.18||0.0158|TWO_SIDED|95.0|-0.78|-0.08|||ANCOVA|||Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with walking ability, and baseline average LBPI as covariates, and study site as a random effect.||-0.08|-0.78|0.0158
72517080|NCT02528253|144564399|SUPERIORITY||LS Mean Difference|-0.56|STANDARD_ERROR_OF_MEAN|0.18||0.0015|TWO_SIDED|95.0|-0.91|-0.21|||ANCOVA|||Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with walking ability, and baseline average LBPI as covariates, and study site as a random effect.||-0.21|-0.91|0.0015
72517081|NCT02528253|144564399|SUPERIORITY||LS Mean Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.16||0.4173|TWO_SIDED|95.0|-0.45|0.19|||ANCOVA|||Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with walking ability, and baseline average LBPI as covariates, and study site as a random effect.||0.19|-0.45|0.4173
72517082|NCT02528253|144564399|SUPERIORITY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.16||0.0659|TWO_SIDED|95.0|-0.62|0.02|||ANCOVA|||Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with walking ability, and baseline average LBPI as covariates, and study site as a random effect.||0.02|-0.62|0.0659
72517083|NCT02528253|144564399|SUPERIORITY||LS Mean Difference|-0.43|STANDARD_ERROR_OF_MEAN|0.16||0.0078|TWO_SIDED|95.0|-0.74|-0.11|||ANCOVA|||Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with walking ability, and baseline average LBPI as covariates, and study site as a random effect.||-0.11|-0.74|0.0078
72517084|NCT02528253|144564399|SUPERIORITY||LS Mean Difference|-0.35|STANDARD_ERROR_OF_MEAN|0.19||0.0737|TWO_SIDED|95.0|-0.72|0.03|||ANCOVA|||Change at Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with walking ability, and baseline average LBPI as covariates, and study site as a random effect.||0.03|-0.72|0.0737
72404830|NCT00782210|144317112|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.098|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.061|0.135|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.135|0.061|<0.0001
72490892|NCT01505634|144509694|OTHER|Event of Clinical Interest (ECI) #2 is elevated AST or ALT ≥3X ULN, elevated total bilirubin ≥2X ULN, and with an ALP \<2X ULN. Inferential testing for statistical significance with p-values and 95% confidence intervals was performed to provide a comparison between the relebactam 125 mg + imipenem/cilastatin group versus the Placebo for relebactam + imipenem/cilastatin group.|Percent Difference|0.0|||>|0.999|TWO_SIDED|95.0|-3.7|3.8||No participants met the criteria for ECI #2.|Miettinen and Nurminen||Relebactam minus Placebo|Percent Diff in Participants with ECI #2||3.8|-3.7|> 0.999
72517085|NCT02528253|144564399|SUPERIORITY||LS Mean Difference|-0.59|STANDARD_ERROR_OF_MEAN|0.19||0.0021|TWO_SIDED|95.0|-0.97|-0.22|||ANCOVA|||Change at Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with walking ability, and baseline average LBPI as covariates, and study site as a random effect.||-0.22|-0.97|0.0021
72517086|NCT02528253|144564399|SUPERIORITY||LS Mean Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.18||0.4535|TWO_SIDED|95.0|-0.48|0.21|||ANCOVA|||Change at Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with walking ability, and baseline average LBPI as covariates, and study site as a random effect.||0.21|-0.48|0.4535
72569021|NCT00807248|144669254|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.26|STANDARD_ERROR_OF_MEAN|0.31|<|0.0001|TWO_SIDED|95.0|-1.87|-0.65|||ANCOVA|||||-0.65|-1.87|<0.0001
72569022|NCT00807248|144669255|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.09|STANDARD_ERROR_OF_MEAN|0.32||0.0007|TWO_SIDED|95.0|-1.72|-0.46|||ANCOVA|||||-0.46|-1.72|0.0007
72569023|NCT00807248|144669255|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.05|STANDARD_ERROR_OF_MEAN|0.33||0.0013|TWO_SIDED|95.0|-1.69|-0.41|||ANCOVA|||||-0.41|-1.69|0.0013
72569024|NCT00807248|144669255|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.29|STANDARD_ERROR_OF_MEAN|0.32|<|0.0001|TWO_SIDED|95.0|-1.92|-0.66|||ANCOVA|||||-0.66|-1.92|<0.0001
72569025|NCT00807248|144669256|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.2|STANDARD_ERROR_OF_MEAN|0.31||0.0002|TWO_SIDED|95.0|-1.82|-0.58|||ANCOVA|||||-0.58|-1.82|0.0002
72624630|NCT01346592|144778951|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was established if the lower limit of the confidence interval of the day 50 ratio of GMTs was \>0.667|GMT ratio (B strain)|3.14|||||TWO_SIDED|97.6|2.72|3.62||||||||3.62|2.72|
72624631|NCT01346592|144778952|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of the confidence interval for day 50 vaccine group difference was \>-10%.|Group difference (H1N1 strain)|9.09|||||TWO_SIDED|97.6|5.48|12.69||||||||12.69|5.48|
72517087|NCT02528253|144564399|SUPERIORITY||LS Mean Difference|-0.21|STANDARD_ERROR_OF_MEAN|0.18||0.2271|TWO_SIDED|95.0|-0.56|0.13|||ANCOVA|||Change at Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with walking ability, and baseline average LBPI as covariates, and study site as a random effect.||0.13|-0.56|0.2271
72517088|NCT02528253|144564399|SUPERIORITY||LS Mean Difference|-0.46|STANDARD_ERROR_OF_MEAN|0.18||0.0086|TWO_SIDED|95.0|-0.81|-0.12|||ANCOVA|||Change at Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with walking ability, and baseline average LBPI as covariates, and study site as a random effect.||-0.12|-0.81|0.0086
72517089|NCT02528253|144564399|SUPERIORITY||LS Mean Difference|-0.24|STANDARD_ERROR_OF_MEAN|0.2||0.2243|TWO_SIDED|95.0|-0.63|0.15|||ANCOVA|||Change at Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with walking ability, and baseline average LBPI as covariates, and study site as a random effect.||0.15|-0.63|0.2243
72517090|NCT02528253|144564399|SUPERIORITY||LS Mean Difference|-0.42|STANDARD_ERROR_OF_MEAN|0.2||0.0331|TWO_SIDED|95.0|-0.81|-0.03|||ANCOVA|||Change at Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with walking ability, and baseline average LBPI as covariates, and study site as a random effect.||-0.03|-0.81|0.0331
72517091|NCT02528253|144564399|SUPERIORITY||LS Mean Difference|-0.27|STANDARD_ERROR_OF_MEAN|0.2||0.1838|TWO_SIDED|95.0|-0.66|0.13|||ANCOVA|||Change at Week 32: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with walking ability, and baseline average LBPI as covariates, and study site as a random effect.||0.13|-0.66|0.1838
72517092|NCT02528253|144564399|SUPERIORITY||LS Mean Difference|-0.35|STANDARD_ERROR_OF_MEAN|0.2||0.0795|TWO_SIDED|95.0|-0.75|0.04|||ANCOVA|||Change at Week 32: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with walking ability, and baseline average LBPI as covariates, and study site as a random effect.||0.04|-0.75|0.0795
72569026|NCT00807248|144669256|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.1|STANDARD_ERROR_OF_MEAN|0.32||0.0006|TWO_SIDED|95.0|-1.72|-0.48|||ANCOVA|||||-0.48|-1.72|0.0006
72569027|NCT00807248|144669256|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.38|STANDARD_ERROR_OF_MEAN|0.32|<|0.0001|TWO_SIDED|95.0|-2.0|-0.76|||ANCOVA|||||-0.76|-2.00|<0.0001
72569028|NCT00807248|144669257|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.61|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-0.89|-0.34|||ANCOVA|||||-0.34|-0.89|<0.0001
72569029|NCT00807248|144669257|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.54|STANDARD_ERROR_OF_MEAN|0.14||0.0001|TWO_SIDED|95.0|-0.82|-0.26|||ANCOVA|||||-0.26|-0.82|0.0001
72569030|NCT00807248|144669257|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.72|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-0.99|-0.44|||ANCOVA|||||-0.44|-0.99|<0.0001
72569031|NCT00807248|144669258|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.76|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-1.02|-0.5|||ANCOVA|||||-0.50|-1.02|<0.0001
72569032|NCT00807248|144669258|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.62|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-0.88|-0.36|||ANCOVA|||||-0.36|-0.88|<0.0001
72569033|NCT00807248|144669258|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.71|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-0.97|-0.45|||ANCOVA|||||-0.45|-0.97|<0.0001
72569034|NCT04442490|144669291|SUPERIORITY||Least Squares (LS) Mean Difference|-1.7|STANDARD_ERROR_OF_MEAN|0.7||0.0141|TWO_SIDED|95.0|-3.1|-0.3|||MMRM||Model used was the MMRM with treatment, baseline HAM-D total score, antidepressant use at baseline (Yes or No), assessment time point, and time point-by-treatment interaction as fixed effects with Unstructured covariance structure.|||-0.3|-3.1|0.0141
72569035|NCT04442490|144669292|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.11||0.1193|TWO_SIDED|95.0|-0.4|0.0|||MMRM||Model used was the MMRM with treatment (SAGE-217 or placebo), baseline CGI-S score, antidepressant use at baseline (Yes or No), assessment time point, and time point-by-treatment interaction as fixed effects with Unstructured covariance structure.|||0.0|-0.4|0.1193
72624632|NCT01346592|144778952|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of the confidence interval for day 50 vaccine group difference was \>-10%|Group difference (H3N2 strain)|4.07|||||TWO_SIDED|97.6|1.58|6.55||||||||6.55|1.58|
72624633|NCT01346592|144778952|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of the confidence interval for day 50 vaccine group difference was \> -10%|Group difference (B strain)|11.82|||||TWO_SIDED|97.6|8.72|14.92||||||||14.92|8.72|
72624634|NCT01346592|144778952|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of the confidence interval for day 50 vaccine group difference was \> -10%|Group difference (H1N1 strain)|14.21|||||TWO_SIDED|97.6|10.3|18.13||||||||18.13|10.3|
72490893|NCT01505634|144509695|OTHER|Difference in percentage and 95% CI are based on unconditional and asymptotic Miettinen and Nurminen method.|Percent Difference|-1.7||||||95.0|-14.3|10.9|||||Relebactam minus Placebo|Percent Diff in Participants with AEs||10.9|-14.3|
72490894|NCT01505634|144509695|OTHER|Difference in percentage and 95% CI are based on unconditional and asymptotic Miettinen and Nurminen method.|Percent Difference|-0.7|||||TWO_SIDED|95.0|-13.4|12.0|||||Relebactam minus Placebo|Percent Diff in Participants with AEs||12.0|-13.4|
72569036|NCT04442490|144669293|SUPERIORITY||LS Mean Difference|-3.0|STANDARD_ERROR_OF_MEAN|0.52|<|0.0001|TWO_SIDED|95.0|-4.0|-2.0|||MMRM||Model used was the MMRM with treatment, baseline HAM-D total score, antidepressant use at baseline (Yes or No), assessment time point, and time point-by-treatment interaction as fixed effects with Unstructured covariance structure.|Change from baseline at Day 3||-2.0|-4.0|<0.0001
72569037|NCT04442490|144669293|SUPERIORITY||LS Mean Difference|-2.6|STANDARD_ERROR_OF_MEAN|0.61|<|0.0001|TWO_SIDED|95.0|-3.8|-1.4|||MMRM||Model used was the MMRM with treatment, baseline HAM-D total score, antidepressant use at baseline (Yes or No), assessment time point, and time point-by-treatment interaction as fixed effects with Unstructured covariance structure.|Change from baseline at Day 8||-1.4|-3.8|<0.0001
72369265|NCT00611026|144248563|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with terms for country and treatment and ranked baseline value as a covariate.||Treatment difference fesoterodine vs placebo at Week 4.||||<0.0001
72490895|NCT01505634|144509696|OTHER|Difference in percentage and 95% CI are based on unconditional and asymptotic Miettinen and Nurminen method.|Percent Difference|0.0|||||TWO_SIDED|95.0|-5.8|5.9|||||Relebactam minus Placebo|Percent Diff in Participants with SAEs||5.9|-5.8|
72517093|NCT02528253|144564399|SUPERIORITY||LS Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.21||0.2847|TWO_SIDED|95.0|-0.63|0.18|||ANCOVA|||Change at Week 40: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with walking ability, and baseline average LBPI as covariates, and study site as a random effect.||0.18|-0.63|0.2847
72517094|NCT02528253|144564399|SUPERIORITY||LS Mean Difference|-0.36|STANDARD_ERROR_OF_MEAN|0.2||0.0745|TWO_SIDED|95.0|-0.76|0.04|||ANCOVA|||Change at Week 40: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with walking ability, and baseline average LBPI as covariates, and study site as a random effect.||0.04|-0.76|0.0745
72517095|NCT02528253|144564399|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.2||0.311|TWO_SIDED|95.0|-0.59|0.19|||ANCOVA|||Change at Week 48: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with walking ability, and baseline average LBPI as covariates, and study site as a random effect.||0.19|-0.59|0.3110
72517096|NCT02528253|144564399|SUPERIORITY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.2||0.1375|TWO_SIDED|95.0|-0.7|0.1|||ANCOVA|||Change at Week 48: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with walking ability, and baseline average LBPI as covariates, and study site as a random effect.||0.10|-0.70|0.1375
72517097|NCT02528253|144564399|SUPERIORITY||LS Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.21||0.4036|TWO_SIDED|95.0|-0.58|0.23|||ANCOVA|||Change at Week 56: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with walking ability, and baseline average LBPI as covariates, and study site as a random effect.||0.23|-0.58|0.4036
72517098|NCT02528253|144564399|SUPERIORITY||LS Mean Difference|-0.38|STANDARD_ERROR_OF_MEAN|0.21||0.0641|TWO_SIDED|95.0|-0.79|0.02|||ANCOVA|||Change at Week 56: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with walking ability, and baseline average LBPI as covariates, and study site as a random effect.||0.02|-0.79|0.0641
72490896|NCT01505634|144509696|OTHER|Difference in percentage and 95% CI are based on unconditional and asymptotic Miettinen and Nurminen method.|Percent Difference|-2.0|||||TWO_SIDED|95.0|-7.6|2.8|||||Relebactam minus Placebo|Percent Diff in Participants with SAEs||2.8|-7.6|
72490897|NCT01505634|144509697|OTHER|Difference in percentage and 95% CI are based on unconditional and asymptotic Miettinen and Nurminen method.|Percent Difference|1.1|||||TWO_SIDED|95.0|-7.5|9.8|||||Relebactam minus Placebo|Percent Diff in Participants with DR AEs||9.8|-7.5|
72569038|NCT04442490|144669293|SUPERIORITY||LS Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|0.76||0.2344|TWO_SIDED|95.0|-2.4|0.6|||MMRM||Model used was the MMRM with treatment, baseline HAM-D total score, antidepressant use at baseline (Yes or No), assessment time point, and time point-by-treatment interaction as fixed effects with Unstructured covariance structure.|Change from baseline at Day 42||0.6|-2.4|0.2344
72624635|NCT01346592|144778952|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of the confidence interval for day 50 vaccine group difference was \> -10%|Group difference (H3N2 strain)|7.31|||||TWO_SIDED|97.6|4.47|10.14||||||||10.14|4.47|
72369266|NCT00611026|144248563|SUPERIORITY_OR_OTHER|||||||0.0008|TWO_SIDED|||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with terms for country and treatment and ranked baseline value as a covariate.||Treatment difference Tolterodine ER vs placebo at Week 4.||||0.0008
72369267|NCT00611026|144248563|SUPERIORITY_OR_OTHER|||||||0.0022|TWO_SIDED|||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with terms for country and treatment and ranked baseline value as a covariate.||Treatment difference Tolterodine ER vs Fesoterodine at Week 4.||||0.0022
72569039|NCT04442490|144669294|SUPERIORITY||Odds Ratio (OR)|1.4||||0.0599|TWO_SIDED|95.0|0.99|1.98|||Generalized Estimating Equation Model|||Day 15|Model used is a GEE for binary response model, with factors for treatment, baseline HAM-D total score, antidepressant use at baseline (Yes or No), assessment time point, and time point-by-treatment interaction with Unstructured covariance structure. Odds ratio was the estimate of the odds of having HAM-D response for participants treated with SAGE-217 relative to that for participants treated with placebo.|1.98|0.99|0.0599
72517099|NCT02528253|144564401|SUPERIORITY||LS Mean Difference|-0.51|STANDARD_ERROR_OF_MEAN|0.18||0.0037|TWO_SIDED|95.0|-0.85|-0.17|||ANCOVA|||Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with sleep, and baseline average LBPI as covariates, and study site as a random effect.||-0.17|-0.85|0.0037
72517100|NCT02528253|144564401|SUPERIORITY||LS Mean Difference|-0.57|STANDARD_ERROR_OF_MEAN|0.18||0.0013|TWO_SIDED|95.0|-0.91|-0.22|||ANCOVA|||Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with sleep, and baseline average LBPI as covariates, and study site as a random effect.||-0.22|-0.91|0.0013
72517101|NCT02528253|144564401|SUPERIORITY||LS Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.16||0.1712|TWO_SIDED|95.0|-0.53|0.09|||ANCOVA|||Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with sleep, and baseline average LBPI as covariates, and study site as a random effect.||0.09|-0.53|0.1712
72517102|NCT02528253|144564401|SUPERIORITY||LS Mean Difference|-0.29|STANDARD_ERROR_OF_MEAN|0.16||0.0686|TWO_SIDED|95.0|-0.6|0.02|||ANCOVA|||Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with sleep, and baseline average LBPI as covariates, and study site as a random effect.||0.02|-0.60|0.0686
72517103|NCT02528253|144564401|SUPERIORITY||LS Mean Difference|-0.35|STANDARD_ERROR_OF_MEAN|0.16||0.0289|TWO_SIDED|95.0|-0.66|-0.04|||ANCOVA|||Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with sleep, and baseline average LBPI as covariates, and study site as a random effect.||-0.04|-0.66|0.0289
72517104|NCT02528253|144564401|SUPERIORITY||LS Mean Difference|-0.66|STANDARD_ERROR_OF_MEAN|0.18||0.0003|TWO_SIDED|95.0|-1.02|-0.3|||ANCOVA|||Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with sleep, and baseline average LBPI as covariates, and study site as a random effect.||-0.30|-1.02|0.0003
72569040|NCT04442490|144669294|SUPERIORITY||Odds Ratio (OR)|1.36||||0.0889|TWO_SIDED|95.0|0.95|1.94|||GEE Model|||Day 42|Model used is a GEE for binary response model, with factors for treatment, baseline HAM-D total score, antidepressant use at baseline (Yes or No), assessment time point, and time point-by-treatment interaction with Unstructured covariance structure.Odds ratio was the estimate of the odds of having HAM-D response for participants treated with SAGE-217 relative to that for participants treated with placebo.|1.94|0.95|0.0889
72569041|NCT04442490|144669295|SUPERIORITY||Odds Ratio (OR)|1.13||||0.5495|TWO_SIDED|95.0|0.76|1.66|||GEE Model|||Day 15|Model used is GEE for binary response model, with factors for treatment, baseline HAM-D total score, antidepressant use at baseline, assessment time point, and time point-by-treatment interaction with Unstructured covariance structure. Odds ratio was the estimate of the odds of having HAM-D remission for participants treated with SAGE-217 relative to that for participants treated with placebo.|1.66|0.76|0.5495
72517105|NCT02528253|144564401|SUPERIORITY||LS Mean Difference|-0.86|STANDARD_ERROR_OF_MEAN|0.19|<|0.0001|TWO_SIDED|95.0|-1.22|-0.49|||ANCOVA|||Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with sleep, and baseline average LBPI as covariates, and study site as a random effect.||-0.49|-1.22|<.0001
72517106|NCT02528253|144564401|SUPERIORITY||LS Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.17||0.2056|TWO_SIDED|95.0|-0.55|0.12|||ANCOVA|||Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with sleep, and baseline average LBPI as covariates, and study site as a random effect.||0.12|-0.55|0.2056
72404831|NCT00782210|144317112|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.101|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.064|0.138|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.138|0.064|<0.0001
72517107|NCT02528253|144564401|SUPERIORITY||LS Mean Difference|-0.45|STANDARD_ERROR_OF_MEAN|0.17||0.0084|TWO_SIDED|95.0|-0.78|-0.11|||ANCOVA|||Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with sleep, and baseline average LBPI as covariates, and study site as a random effect.||-0.11|-0.78|0.0084
72517108|NCT02528253|144564401|SUPERIORITY||LS Mean Difference|-0.64|STANDARD_ERROR_OF_MEAN|0.17||0.0002|TWO_SIDED|95.0|-0.98|-0.31|||ANCOVA|||Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with sleep, and baseline average LBPI as covariates, and study site as a random effect.||-0.31|-0.98|0.0002
72569042|NCT04442490|144669295|SUPERIORITY||Odds Ratio (OR)|1.09||||0.679|TWO_SIDED|95.0|0.74|1.6|||GEE Model|||Day 42|Model used is GEE for binary response model, with factors for treatment, baseline HAM-D total score, antidepressant use at baseline, assessment time point, and time point-by-treatment interaction with Unstructured covariance structure. Odds ratio was the estimate of the odds of having HAM-D remission for participants treated with SAGE-217 relative to that for participants treated with placebo.|1.60|0.74|0.6790
72624636|NCT01346592|144778952|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of the confidence interval for day 50 vaccine group difference was \> -10%|Group difference (B strain)|11.1|||||TWO_SIDED|97.6|8.11|14.1||||||||14.1|8.11|
72404832|NCT00782210|144317113|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.086|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.049|0.123|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.123|0.049|<0.0001
72404833|NCT00782210|144317113|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.089|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.051|0.126|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.126|0.051|<0.0001
72404834|NCT00782210|144317114|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.092|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.054|0.13|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.130|0.054|<0.0001
72404835|NCT00782210|144317114|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.085|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.048|0.123|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.123|0.048|<0.0001
72404836|NCT00782210|144317115|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.107|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.069|0.145|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.145|0.069|<0.0001
72404837|NCT00782210|144317115|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.105|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.068|0.143|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.143|0.068|<0.0001
72404838|NCT00782210|144317116|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.092|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.055|0.13|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.130|0.055|<0.0001
72404839|NCT00782210|144317116|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.091|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.053|0.129|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.129|0.053|<0.0001
72404840|NCT00782210|144317117|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.155|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001||95.0|0.115|0.194|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.194|0.115|<0.0001
72490898|NCT01505634|144509697|OTHER|Difference in percentage and 95% CI are based on unconditional and asymptotic Miettinen and Nurminen method.|Percent Difference|0.1|||||TWO_SIDED|95.0|-8.4|8.6|||||Relebactam minus Placebo|Percent Diff in Participants with DR AEs||8.6|-8.4|
72490899|NCT01505634|144509698|OTHER|Difference in percentage and 95% CI are based on unconditional and asymptotic Miettinen and Nurminen method.|Percent Difference|0.0|||||TWO_SIDED|95.0|-4.5|4.6|||||Relebactam minus Placebo|Percent Diff in Participants with DR SAEs||4.6|-4.5|
72490900|NCT01505634|144509698|OTHER|Difference in percentage and 95% CI are based on unconditional and asymptotic Miettinen and Nurminen method.|Percent Difference|-1.0|||||TWO_SIDED|95.0|-5.5|2.8|||||Relebactam minus Placebo|Percent Diff in Participants with DR SAEs||2.8|-5.5|
72490901|NCT01505634|144509699|OTHER|Difference in percentage and 95% CI are based on unconditional and asymptotic Miettinen and Nurminen method.|Percent Difference|1.0|||||TWO_SIDED|95.0|-4.4|6.8|||||Relebactam minus Placebo|Percent Diff in Participants with Discons Due to AEs||6.8|-4.4|
72517109|NCT02528253|144564401|SUPERIORITY||LS Mean Difference|-0.52|STANDARD_ERROR_OF_MEAN|0.19||0.0063|TWO_SIDED|95.0|-0.9|-0.15|||ANCOVA|||Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with sleep, and baseline average LBPI as covariates, and study site as a random effect.||-0.15|-0.90|0.0063
72517110|NCT02528253|144564401|SUPERIORITY||LS Mean Difference|-0.72|STANDARD_ERROR_OF_MEAN|0.19||0.0002|TWO_SIDED|95.0|-1.09|-0.34|||ANCOVA|||Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with sleep, and baseline average LBPI as covariates, and study site as a random effect.||-0.34|-1.09|0.0002
72490902|NCT01505634|144509699|OTHER|Difference in percentage and 95% CI are based on unconditional and asymptotic Miettinen and Nurminen method.|Percent Difference|-1.0|||||TWO_SIDED|95.0|-6.1|3.7|||||Relebactam minus Placebo|Percent Diff in Participants with Discons Due to AEs||3.7|-6.1|
72404841|NCT00782210|144317117|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.171|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001||95.0|0.131|0.211|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.211|0.131|<0.0001
72404842|NCT00782210|144317118|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.177|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001||95.0|0.137|0.217|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.217|0.137|<0.0001
72490903|NCT01505634|144509700|OTHER|Difference in percentage and 95% CI are based on unconditional and asymptotic Miettinen and Nurminen method.|Percent Difference|1.0|||||TWO_SIDED|95.0|-3.6|6.2|||||Relebactam minus Placebo|Percent Diff in Participants with Discons Due to DR AEs||6.2|-3.6|
72490904|NCT01505634|144509700|OTHER|Difference in percentage and 95% CI are based on unconditional and asymptotic Miettinen and Nurminen method.|Percent Difference|0.0|||||TWO_SIDED|95.0|-4.5|4.6|||||Relebactam minus Placebo|Percent Diff in Participants with Discons Due to DR AEs||4.6|-4.5|
72490905|NCT01505634|144509701|OTHER|Difference in percentage and 95% CI are based on unconditional and asymptotic Miettinen and Nurminen method.|Percent Difference|1.1|||||TWO_SIDED|95.0|-5.5|7.8|||||Relebactam minus Placebo|Percent Diff in Participants with AEs with Rate ≥4: Diarrhoea||7.8|-5.5|
72404843|NCT00782210|144317118|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.19|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001||95.0|0.15|0.23|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.230|0.150|<0.0001
72517111|NCT02528253|144564401|SUPERIORITY||LS Mean Difference|-0.28|STANDARD_ERROR_OF_MEAN|0.18||0.1155|TWO_SIDED|95.0|-0.63|0.07|||ANCOVA|||Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with sleep, and baseline average LBPI as covariates, and study site as a random effect.||0.07|-0.63|0.1155
72517112|NCT02528253|144564401|SUPERIORITY||LS Mean Difference|-0.24|STANDARD_ERROR_OF_MEAN|0.18||0.1652|TWO_SIDED|95.0|-0.59|0.1|||ANCOVA|||Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with sleep, and baseline average LBPI as covariates, and study site as a random effect.||0.10|-0.59|0.1652
72517113|NCT02528253|144564401|SUPERIORITY||LS Mean Difference|-0.44|STANDARD_ERROR_OF_MEAN|0.18||0.0129|TWO_SIDED|95.0|-0.78|-0.09|||ANCOVA|||Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with sleep, and baseline average LBPI as covariates, and study site as a random effect.||-0.09|-0.78|0.0129
72517114|NCT02528253|144564401|SUPERIORITY||LS Mean Difference|-0.46|STANDARD_ERROR_OF_MEAN|0.21||0.0236|TWO_SIDED|95.0|-0.87|-0.06|||ANCOVA|||Change at Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with sleep, and baseline average LBPI as covariates, and study site as a random effect.||-0.06|-0.87|0.0236
72517115|NCT02528253|144564401|SUPERIORITY||LS Mean Difference|-0.52|STANDARD_ERROR_OF_MEAN|0.21||0.0136|TWO_SIDED|95.0|-0.93|-0.11|||ANCOVA|||Change at Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with sleep, and baseline average LBPI as covariates, and study site as a random effect.||-0.11|-0.93|0.0136
72517116|NCT02528253|144564401|SUPERIORITY||LS Mean Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.2||0.6624|TWO_SIDED|95.0|-0.47|0.3|||ANCOVA|||Change at Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with sleep, and baseline average LBPI as covariates, and study site as a random effect.||0.30|-0.47|0.6624
72517117|NCT02528253|144564401|SUPERIORITY||LS Mean Difference|-0.38|STANDARD_ERROR_OF_MEAN|0.19||0.0468|TWO_SIDED|95.0|-0.75|-0.01|||ANCOVA|||Change at Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with sleep, and baseline average LBPI as covariates, and study site as a random effect.||-0.01|-0.75|0.0468
72517118|NCT02528253|144564401|SUPERIORITY||LS Mean Difference|-0.43|STANDARD_ERROR_OF_MEAN|0.19||0.025|TWO_SIDED|95.0|-0.81|-0.05|||ANCOVA|||Change at Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with sleep, and baseline average LBPI as covariates, and study site as a random effect.||-0.05|-0.81|0.0250
72517119|NCT02528253|144564401|SUPERIORITY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.21||0.1539|TWO_SIDED|95.0|-0.72|0.11|||ANCOVA|||Change at Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with sleep, and baseline average LBPI as covariates, and study site as a random effect.||0.11|-0.72|0.1539
72517120|NCT02528253|144564401|SUPERIORITY||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.21||0.0169|TWO_SIDED|95.0|-0.91|-0.09|||ANCOVA|||Change at Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with sleep, and baseline average LBPI as covariates, and study site as a random effect.||-0.09|-0.91|0.0169
72624637|NCT01346592|144778953|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of the confidence interval for day 50 GMT group ratios was \>0.667|Group ratio (H1N1 strain)|0.76|||||TWO_SIDED|97.4|0.62|0.93||||||||0.93|0.62|
72517121|NCT02528253|144564401|SUPERIORITY||LS Mean Difference|-0.35|STANDARD_ERROR_OF_MEAN|0.21||0.1049|TWO_SIDED|95.0|-0.77|0.07|||ANCOVA|||Change at Week 32: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with sleep, and baseline average LBPI as covariates, and study site as a random effect.||0.07|-0.77|0.1049
72517122|NCT02528253|144564401|SUPERIORITY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.21||0.0599|TWO_SIDED|95.0|-0.82|0.02|||ANCOVA|||Change at Week 32: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with sleep, and baseline average LBPI as covariates, and study site as a random effect.||0.02|-0.82|0.0599
72517123|NCT02528253|144564401|SUPERIORITY||LS Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.22||0.3041|TWO_SIDED|95.0|-0.65|0.2|||ANCOVA|||Change at Week 40: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with sleep, and baseline average LBPI as covariates, and study site as a random effect.||0.20|-0.65|0.3041
72624638|NCT01346592|144778953|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of the confidence interval for day 50 GMT group ratios was \>0.667|GMT ratio (H3N2 strain)|0.77|||||TWO_SIDED|97.4|0.68|0.86||||||||0.86|0.68|
72624639|NCT01346592|144778953|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of the confidence interval for day 50 GMT group ratios was \>0.667|GMT ratio (B strain)|0.94|||||TWO_SIDED|97.4|0.8|1.11||||||||1.11|0.8|
72624640|NCT01346592|144778954|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of the confidence interval for day 50 vaccine group differences was \> -10%|Group difference (H1N1 strain)|-5.3|||||TWO_SIDED|97.4|-10.13|-0.47||||||||-0.47|-10.13|
72404844|NCT00782210|144317119|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.172|STANDARD_ERROR_OF_MEAN|0.021|<|0.0001||95.0|0.132|0.212|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.212|0.132|<0.0001
72404845|NCT00782210|144317119|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.172|STANDARD_ERROR_OF_MEAN|0.021|<|0.0001||95.0|0.132|0.212|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.212|0.132|<0.0001
72404846|NCT00782210|144317120|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.164|STANDARD_ERROR_OF_MEAN|0.021|<|0.0001||95.0|0.123|0.204|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.204|0.123|<0.0001
72404847|NCT00782210|144317120|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.165|STANDARD_ERROR_OF_MEAN|0.021|<|0.0001||95.0|0.124|0.206|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.206|0.124|<0.0001
72404848|NCT00782210|144317121|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.175|STANDARD_ERROR_OF_MEAN|0.021|<|0.0001||95.0|0.134|0.216|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.216|0.134|<0.0001
72517124|NCT02528253|144564401|SUPERIORITY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.22||0.0737|TWO_SIDED|95.0|-0.83|0.04|||ANCOVA|||Change at Week 40: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with sleep, and baseline average LBPI as covariates, and study site as a random effect.||0.04|-0.83|0.0737
72517125|NCT02528253|144564401|SUPERIORITY||LS Mean Difference|-0.27|STANDARD_ERROR_OF_MEAN|0.23||0.2293|TWO_SIDED|95.0|-0.71|0.17|||ANCOVA|||Change at Week 48: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with sleep, and baseline average LBPI as covariates, and study site as a random effect.||0.17|-0.71|0.2293
72517126|NCT02528253|144564401|SUPERIORITY||LS Mean Difference|-0.39|STANDARD_ERROR_OF_MEAN|0.22||0.0806|TWO_SIDED|95.0|-0.82|0.05|||ANCOVA|||Change at Week 48: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with sleep, and baseline average LBPI as covariates, and study site as a random effect.||0.05|-0.82|0.0806
72517127|NCT02528253|144564401|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.22||0.368|TWO_SIDED|95.0|-0.62|0.23|||ANCOVA|||Change at Week 56: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with sleep, and baseline average LBPI as covariates, and study site as a random effect.||0.23|-0.62|0.3680
72517128|NCT02528253|144564401|SUPERIORITY||LS Mean Difference|-0.36|STANDARD_ERROR_OF_MEAN|0.21||0.0893|TWO_SIDED|95.0|-0.79|0.06|||ANCOVA|||Change at Week 56: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with sleep, and baseline average LBPI as covariates, and study site as a random effect.||0.06|-0.79|0.0893
72517129|NCT02528253|144564403|SUPERIORITY||LS Mean Difference|-0.56|STANDARD_ERROR_OF_MEAN|0.16||0.0007|TWO_SIDED|95.0|-0.88|-0.24|||ANCOVA|||Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with normal work, and baseline average LBPI as covariates, and study site as a random effect.||-0.24|-0.88|0.0007
72517130|NCT02528253|144564403|SUPERIORITY||LS Mean Difference|-0.71|STANDARD_ERROR_OF_MEAN|0.17|<|0.0001|TWO_SIDED|95.0|-1.03|-0.38|||ANCOVA|||Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with normal work, and baseline average LBPI as covariates, and study site as a random effect.||-0.38|-1.03|<.0001
72624641|NCT01346592|144778954|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of the confidence interval for day 50 vaccine group differences was \> -10%|Group difference (H3N2 strain)|-2.84|||||TWO_SIDED|97.4|-6.16|0.5||||||||0.5|-6.16|
72404849|NCT00782210|144317121|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.151|STANDARD_ERROR_OF_MEAN|0.021|<|0.0001||95.0|0.11|0.192|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.192|0.110|<0.0001
72517131|NCT02528253|144564403|SUPERIORITY||LS Mean Difference|-0.23|STANDARD_ERROR_OF_MEAN|0.15||0.1291|TWO_SIDED|95.0|-0.53|0.07|||ANCOVA|||Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with normal work, and baseline average LBPI as covariates, and study site as a random effect.||0.07|-0.53|0.1291
72624642|NCT01346592|144778954|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of the confidence interval for day 50 vaccine group differences was \> -10%|Group difference (B strain)|-2.49|||||TWO_SIDED|97.4|-7.01|2.0||||||||2|-7.01|
72624643|NCT01346592|144778955|SUPERIORITY_OR_OTHER||GMT ratio (H1N1 strain)|3.63|||||TWO_SIDED|95.0|2.86|4.6||||||Superiority was concluded if the lower limit of the confidence interval for the day 50 vaccine group GMT ratios for at least 2 homologous strains was \>1.5.||4.6|2.86|
72624644|NCT01346592|144778955|SUPERIORITY_OR_OTHER||GMT ratio (H3N2 strain)|2.25|||||TWO_SIDED|95.0|1.96|2.59||||||superiority was concluded if the lower limit of the confidence interval of the day 50 vaccine group GMT ratios for at least 2 homologous strains was \>1.5||2.59|1.96|
72569043|NCT04442490|144669296|SUPERIORITY||Odds Ratio (OR)|1.52||||0.0191|TWO_SIDED|95.0|1.07|2.16|||GEE Model|||Placebo, SAGE-217|Model used was a GEE for binary response model, with factors for treatment, CGI-S baseline score, antidepressant use at baseline (Yes or No), assessment time point, and time point-by-treatment interaction with Unstructured covariance structure. Odds ratio was the estimate of the odds of having CGI-I response for participants treated with SAGE-217 relative to that for participants treated with placebo.|2.16|1.07|0.0191
72404850|NCT00782210|144317122|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.169|STANDARD_ERROR_OF_MEAN|0.021|<|0.0001||95.0|0.128|0.211|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.211|0.128|<0.0001
72404851|NCT00782210|144317122|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.163|STANDARD_ERROR_OF_MEAN|0.021|<|0.0001||95.0|0.121|0.205|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.205|0.121|<0.0001
72404852|NCT00782210|144317123|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.288|STANDARD_ERROR_OF_MEAN|0.037|<|0.0001||95.0|0.216|0.359|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.359|0.216|<0.0001
72404853|NCT00782210|144317123|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.33|STANDARD_ERROR_OF_MEAN|0.037|<|0.0001||95.0|0.258|0.401|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.401|0.258|<0.0001
72404854|NCT00782210|144317124|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.296|STANDARD_ERROR_OF_MEAN|0.037|<|0.0001||95.0|0.224|0.368|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.368|0.224|<0.0001
72404855|NCT00782210|144317124|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.327|STANDARD_ERROR_OF_MEAN|0.037|<|0.0001||95.0|0.255|0.399|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.399|0.255|<0.0001
72569044|NCT04442490|144669297|SUPERIORITY||LS Mean Difference|-2.4|STANDARD_ERROR_OF_MEAN|1.05||0.0238|TWO_SIDED|95.0|-4.4|-0.3|||MMRM||Model used was the MMRM with treatment (SAGE-217/placebo), baseline MADRS total score, antidepressant use at baseline (Yes or No), assessment time point, and time point-by-treatment interaction as fixed effects with Unstructured covariance structure|Placebo, SAGE-217||-0.3|-4.4|0.0238
72404856|NCT00782210|144317125|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.254|STANDARD_ERROR_OF_MEAN|0.037|<|0.0001||95.0|0.181|0.327|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.327|0.181|<0.0001
72404857|NCT00782210|144317125|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.293|STANDARD_ERROR_OF_MEAN|0.037|<|0.0001||95.0|0.22|0.366|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.366|0.220|<0.0001
72404858|NCT00782210|144317126|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.275|STANDARD_ERROR_OF_MEAN|0.037|<|0.0001||95.0|0.201|0.348|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.348|0.201|<0.0001
72404859|NCT00782210|144317126|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.292|STANDARD_ERROR_OF_MEAN|0.037|<|0.0001||95.0|0.219|0.366|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.366|0.219|<0.0001
72404860|NCT00782210|144317127|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.235|STANDARD_ERROR_OF_MEAN|0.038|<|0.0001||95.0|0.161|0.309|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.309|0.161|<0.0001
72404861|NCT00782210|144317127|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.254|STANDARD_ERROR_OF_MEAN|0.038|<|0.0001||95.0|0.18|0.329|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.329|0.180|<0.0001
72490906|NCT01505634|144509701|OTHER|Difference in percentage and 95% CI are based on unconditional and asymptotic Miettinen and Nurminen method.|Percent Difference|-2.0|||||TWO_SIDED|95.0|-8.1|3.6|||||Relebactam minus Placebo|Percent Diff in Participants with AEs with Rate ≥4: Diarrhoea||3.6|-8.1|
72490907|NCT01505634|144509701|OTHER|Difference in percentage and 95% CI are based on unconditional and asymptotic Miettinen and Nurminen method.|Percent Difference|0.0|||||TWO_SIDED|95.0|-6.4|6.5|||||Relebactam minus Placebo|Percent Diff in Participants with AEs with Rate ≥4: Nausea||6.5|-6.4|
72490908|NCT01505634|144509701|OTHER|Difference in percentage and 95% CI are based on unconditional and asymptotic Miettinen and Nurminen method.|Percent Difference|2.1|||||TWO_SIDED|95.0|-4.6|9.2|||||Relebactam minus Placebo|Percent Diff in Participants with AEs with Rate ≥4: Nausea||9.2|-4.6|
72490909|NCT01505634|144509701|OTHER|Difference in percentage and 95% CI are based on unconditional and asymptotic Miettinen and Nurminen method.|Percent Difference|-3.0|||||TWO_SIDED|95.0|-9.0|1.9|||||Relebactam minus Placebo|Percent Diff in Participants with AEs with Rate ≥4: Bacteriuria||1.9|-9.0|
72569045|NCT04442490|144669298|SUPERIORITY||LS Mean Difference|-1.4|STANDARD_ERROR_OF_MEAN|0.58||0.0199|TWO_SIDED|95.0|-2.5|-0.2|||MMRM||Model used was MMRM with treatment (SAGE-217/placebo), baseline HAM-A total score, antidepressant use at baseline (Yes or No), assessment time point, and time point-by-treatment interaction as fixed effects with Unstructured covariance structure.|Placebo, SAGE-217||-0.2|-2.5|0.0199
72569046|NCT04442490|144669300|SUPERIORITY||LS Mean Difference|0.5|STANDARD_ERROR_OF_MEAN|0.5||0.3216|TWO_SIDED|95.0|-0.5|1.5|||MMRM||Model used is MMRM with treatment(SAGE-217/placebo), baseline SF-36v2 domain/component score, antidepressant use at baseline(Yes/No)assessment time point and time point-by-treatment interaction as fixed effects with Unstructured covariance structure.|Physical Functioning Domain Score: Change from Baseline at Day 8||1.5|-0.5|0.3216
72569047|NCT04442490|144669300|SUPERIORITY||LS Mean Difference|0.8|STANDARD_ERROR_OF_MEAN|0.53||0.1247|TWO_SIDED|95.0|-0.2|1.8|||MMRM||Model used is MMRM with treatment(SAGE-217/placebo), baseline SF-36v2 domain/component score, antidepressant use at baseline(Yes/No)assessment time point and time point-by-treatment interaction as fixed effects with Unstructured covariance structure.|Physical Functioning Domain Score: Change from Baseline at Day 15||1.8|-0.2|0.1247
72569048|NCT04442490|144669300|SUPERIORITY||LS Mean Difference|0.9|STANDARD_ERROR_OF_MEAN|0.56||0.1111|TWO_SIDED|95.0|-0.2|2.0|||MMRM||Model used is MMRM with treatment(SAGE-217/placebo), baseline SF-36v2 domain/component score, antidepressant use at baseline(Yes/No)assessment time point and time point-by-treatment interaction as fixed effects with Unstructured covariance structure.|Physical Functioning Domain Score: Change from Baseline at Day 28||2.0|-0.2|0.1111
72569049|NCT04442490|144669300|SUPERIORITY||LS Mean Difference|0.9|STANDARD_ERROR_OF_MEAN|0.59||0.1449|TWO_SIDED|95.0|-0.3|2.0|||MMRM||Model used is MMRM with treatment(SAGE-217/placebo), baseline SF-36v2 domain/component score, antidepressant use at baseline(Yes/No)assessment time point and time point-by-treatment interaction as fixed effects with Unstructured covariance structure.|Physical Functioning Domain Score: Change from Baseline at Day 42||2.0|-0.3|0.1449
72569050|NCT04442490|144669300|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.59||0.8242|TWO_SIDED|95.0|-1.3|1.0|||MMRM||Model used is MMRM with treatment(SAGE-217/placebo), baseline SF-36v2 domain/component score, antidepressant use at baseline(Yes/No)assessment time point and time point-by-treatment interaction as fixed effects with Unstructured covariance structure.|Role-Physical Domain Score: Change from Baseline at Day 8||1.0|-1.3|0.8242
72569051|NCT04442490|144669300|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.62||0.8329|TWO_SIDED|95.0|-1.4|1.1|||MMRM|||Role-Physical Domain Score: Change from Baseline at Day 15||1.1|-1.4|0.8329
72404862|NCT00782210|144317128|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.244|STANDARD_ERROR_OF_MEAN|0.038|<|0.0001||95.0|0.169|0.319|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.319|0.169|<0.0001
72569052|NCT04442490|144669300|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.63||0.8127|TWO_SIDED|95.0|-1.4|1.1|||MMRM|||Role-Physical Domain Score: Change from Baseline at Day 28||1.1|-1.4|0.8127
72569053|NCT04442490|144669300|SUPERIORITY||LS Mean Difference|0.4|STANDARD_ERROR_OF_MEAN|0.64||0.5435|TWO_SIDED|95.0|-0.9|1.6|||MMRM|||Role-Physical Domain Score: Change from Baseline at Day 42||1.6|-0.9|0.5435
72624645|NCT01346592|144778955|SUPERIORITY_OR_OTHER||GMT ratio (B strain)|4.64|||||TWO_SIDED|95.0|3.86|5.59||||||superiority was concluded if the lower limit of the confidence interval of the day 50 vaccine group GMT ratios for at least 2 homologous strains was \>1.5||5.59|3.86|
72404863|NCT00782210|144317128|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.271|STANDARD_ERROR_OF_MEAN|0.038|<|0.0001||95.0|0.196|0.346|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.346|0.196|<0.0001
72404864|NCT00782210|144317129|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.147|STANDARD_ERROR_OF_MEAN|0.036|<|0.0001||95.0|0.076|0.218|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.218|0.076|<0.0001
72569054|NCT04442490|144669300|SUPERIORITY||LS Mean Difference|0.6|STANDARD_ERROR_OF_MEAN|0.63||0.3551|TWO_SIDED|95.0|-0.7|1.8|||MMRM|||Bodily Pain Domain Score: Change from Baseline at Day 8||1.8|-0.7|0.3551
72569055|NCT04442490|144669300|SUPERIORITY||LS Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|0.68||0.7495|TWO_SIDED|95.0|-1.1|1.6|||MMRM|||Bodily Pain Domain Score: Change from Baseline at Day 15||1.6|-1.1|0.7495
72569056|NCT04442490|144669300|SUPERIORITY||LS Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|0.7||0.6471|TWO_SIDED|95.0|-1.1|1.7|||MMRM|||Bodily Pain Domain Score: Change from Baseline at Day 28||1.7|-1.1|0.6471
72569057|NCT04442490|144669300|SUPERIORITY||LS Mean Difference|1.0|STANDARD_ERROR_OF_MEAN|0.75||0.1832|TWO_SIDED|95.0|-0.5|2.5|||MMRM|||Bodily Pain Domain Score: Change from Baseline at Day 42||2.5|-0.5|0.1832
72569058|NCT04442490|144669300|SUPERIORITY||LS Mean Difference|1.2|STANDARD_ERROR_OF_MEAN|0.5||0.0168|TWO_SIDED|95.0|0.2|2.2|||MMRM|||General Health Domain Score: Change from Baseline at Day 8||2.2|0.2|0.0168
72569059|NCT04442490|144669300|SUPERIORITY||LS Mean Difference|1.0|STANDARD_ERROR_OF_MEAN|0.54||0.0787|TWO_SIDED|95.0|-0.1|2.0|||MMRM|||General Health Domain Score: Change from Baseline at Day 15||2.0|-0.1|0.0787
72569060|NCT04442490|144669300|SUPERIORITY||LS Mean Difference|0.5|STANDARD_ERROR_OF_MEAN|0.59||0.4273|TWO_SIDED|95.0|-0.7|1.6|||MMRM|||General Health Domain Score: Change from Baseline at Day 28||1.6|-0.7|0.4273
72569061|NCT04442490|144669300|SUPERIORITY||LS Mean Difference|1.0|STANDARD_ERROR_OF_MEAN|0.62||0.0938|TWO_SIDED|95.0|-0.2|2.2|||MMRM|||General Health Domain Score: Change from Baseline at Day 42||2.2|-0.2|0.0938
72569062|NCT04442490|144669300|SUPERIORITY||LS Mean Difference|2.6|STANDARD_ERROR_OF_MEAN|0.88||0.0033|TWO_SIDED|95.0|0.9|4.3|||MMRM|||Vitality Domain Score: Change from Baseline at Day 8||4.3|0.9|0.0033
72569063|NCT04442490|144669300|SUPERIORITY||LS Mean Difference|3.1|STANDARD_ERROR_OF_MEAN|1.03||0.0029|TWO_SIDED|95.0|1.1|5.1|||MMRM|||Vitality Domain Score: Change from Baseline at Day 15||5.1|1.1|0.0029
72569064|NCT04442490|144669300|SUPERIORITY||LS Mean Difference|1.8|STANDARD_ERROR_OF_MEAN|1.04||0.0791|TWO_SIDED|95.0|-0.2|3.9|||MMRM|||Vitality Domain Score: Change from Baseline at Day 28||3.9|-0.2|0.0791
72569065|NCT04442490|144669300|SUPERIORITY||LS Mean Difference|2.0|STANDARD_ERROR_OF_MEAN|1.12||0.0761|TWO_SIDED|95.0|-0.2|4.2|||MMRM|||Vitality Domain Score: Change from Baseline at Day 42||4.2|-0.2|0.0761
72569066|NCT04442490|144669300|SUPERIORITY||LS Mean Difference|1.3|STANDARD_ERROR_OF_MEAN|0.91||0.1568|TWO_SIDED|95.0|-0.5|3.1|||MMRM|||Social Functioning Domain Score: Change from Baseline at Day 8||3.1|-0.5|0.1568
72569067|NCT04442490|144669300|SUPERIORITY||LS Mean Difference|1.1|STANDARD_ERROR_OF_MEAN|0.99||0.2807|TWO_SIDED|95.0|-0.9|3.0|||MMRM|||Social Functioning Domain Score: Change from Baseline at Day 15||3.0|-0.9|0.2807
72624646|NCT01346592|144778955|SUPERIORITY_OR_OTHER||GMT ratio (H1N1 strain)|5.28|||||TWO_SIDED|95.0|4.16|6.7||||||superiority was concluded if the lower limit of the confidence interval of the day 50 vaccine group GMT ratios for at least 2 homologous strains was \>1.5||6.7|4.16|
72404865|NCT00782210|144317129|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.184|STANDARD_ERROR_OF_MEAN|0.036|<|0.0001||95.0|0.113|0.255|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.255|0.113|<0.0001
72490910|NCT01505634|144509701|OTHER|Difference in percentage and 95% CI are based on unconditional and asymptotic Miettinen and Nurminen method.|Percent Difference|-2.0|||||TWO_SIDED|95.0|-8.1|3.6|||||Relebactam minus Placebo|Percent Diff in Participants with AEs with Rate ≥4: Bacteriuria||3.6|-8.1|
72490911|NCT01505634|144509701|OTHER|Difference in percentage and 95% CI are based on unconditional and asymptotic Miettinen and Nurminen method.|Percent Difference|-3.0|||||TWO_SIDED|95.0|-9.0|1.9|||||Relebactam minus Placebo|Percent Diff in Participants with AEs with Rate ≥4: White blood cells urine positive||1.9|-9.0|
72490912|NCT01505634|144509701|OTHER|Difference in percentage and 95% CI are based on unconditional and asymptotic Miettinen and Nurminen method.|Percent Difference|-3.0|||||TWO_SIDED|95.0|-9.0|1.9|||||Relebactam minus Placebo|Percent Diff in Participants with AEs with Rate ≥4: White blood cells urine positive||1.9|-9.0|
72490913|NCT01505634|144509701|OTHER|Difference in percentage and 95% CI are based on unconditional and asymptotic Miettinen and Nurminen method.|Percent Difference|3.1|||||TWO_SIDED|95.0|-3.7|10.4|||||Relebactam minus Placebo|Percent Diff in Participants with AEs with Rate ≥4: Headache||10.4|-3.7|
72490914|NCT01505634|144509701|OTHER|Difference in percentage and 95% CI are based on unconditional and asymptotic Miettinen and Nurminen method.|Percent Difference|-1.0|||||TWO_SIDED|95.0|-7.2|5.1|||||Relebactam minus Placebo|Percent Diff in Participants with AEs with Rate ≥4: Headache||5.1|-7.2|
72490915|NCT02054897|144509708|SUPERIORITY|Superiority for change in HbA1c was claimed if the upper limit of the 2-sided 95% confidence interval (CI) for the estimated difference was below 0%.|Treatment difference|-1.53|||<|0.0001|TWO_SIDED|95.0|-1.81|-1.25|||Mixed Models Analysis||Semaglutide 1.0 mg minus Placebo|For the primary HbA1c endpoint, superiority was planned to be tested for semaglutide 1.0 mg versus placebo. The post-baseline responses were analysed using a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit.||-1.25|-1.81|< 0.0001
72490916|NCT02054897|144509708|SUPERIORITY|Superiority for change in HbA1c was claimed if the upper limit of the 2-sided 95% CI for the estimated difference was below 0%.|Treatment difference|-1.43|||<|0.0001|TWO_SIDED|95.0|-1.71|-1.15|||Mixed Models Analysis||Semaglutide 0.5 mg minus Placebo|For the primary HbA1c endpoint, superiority was planned to be tested for semaglutide 0.5 mg versus placebo, if superiority for semaglutide 1.0 mg was concluded. The post-baseline responses were analysed using a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit.||-1.15|-1.71|< 0.0001
72490917|NCT01692275|144509719|SUPERIORITY||Mean Difference (Final Values)|-1.1|||||TWO_SIDED|95.0|-1.4|-0.7||||||All sites combined (week 6) - Between-group differences of mean in LBP||-0.7|-1.4|
72490918|NCT01692275|144509719|SUPERIORITY||Mean Difference (Final Values)|-0.9|||||TWO_SIDED|95.0|-1.2|-0.5||||||All sites combined (week 12) - Between-group differences of mean in LBP||-0.5|-1.2|
72490919|NCT01692275|144509719|SUPERIORITY||Mean Difference (Final Values)|-0.7|||||TWO_SIDED|95.0|-1.3|-0.1||||||Walter Reed site (week 6) - Between-group differences of mean in LBP||-0.1|-1.3|
72490920|NCT01692275|144509719|SUPERIORITY||Mean Difference (Final Values)|-0.4|||||TWO_SIDED|95.0|-1.0|0.2||||||Walter Reed site (week 12) - Between-group differences of mean in LBP||0.2|-1.0|
72490921|NCT01692275|144509719|SUPERIORITY||Mean Difference (Final Values)|-1.2|||||TWO_SIDED|95.0|-1.8|-0.6||||||Naval Hospital Pensacola site (week 6) - Between-group differences of mean in LBP||-0.6|-1.8|
72490922|NCT01692275|144509719|SUPERIORITY||Mean Difference (Final Values)|-1.1|||||TWO_SIDED|95.0|-1.8|-0.5||||||Naval Hospital Pensacola site (week 12) - Between-group differences of mean in LBP||-0.5|-1.8|
72490923|NCT01692275|144509719|SUPERIORITY||Mean Difference (Final Values)|-1.3|||||TWO_SIDED|95.0|-1.9|-0.8||||||Naval Medical Center San Diego site (week 6) - Between-group differences of mean in LBP||-0.8|-1.9|
72490924|NCT01692275|144509719|SUPERIORITY||Mean Difference (Final Values)|-1.1|||||TWO_SIDED|95.0|-1.7|-0.5||||||Naval Medical Center San Diego (week 12) - Between-group differences of mean in LBP||-0.5|-1.7|
72490925|NCT01692275|144509720|SUPERIORITY||Mean Difference (Final Values)|-2.2|||||TWO_SIDED|95.0|-3.1|-1.2||||||All sites combined (week 6) - RMDQ Between-Group Differences in Disability||-1.2|-3.1|
72490926|NCT01692275|144509720|SUPERIORITY||Mean Difference (Final Values)|-2.0|||||TWO_SIDED|95.0|-3.0|-1.0||||||All sites combined (week 12) - RMDQ Between-Group Differences in Disability||-1.0|-3.0|
72490927|NCT01692275|144509720|SUPERIORITY||Mean Difference (Final Values)|-1.8|||||TWO_SIDED|95.0|-3.4|-0.2||||||Walter Reed site (week 6) - RMDQ Between-Group Differences in Disability||-0.2|-3.4|
72490928|NCT01692275|144509720|SUPERIORITY||Mean Difference (Final Values)|-1.5|||||TWO_SIDED|95.0|-3.2|0.2||||||Walter Reed site (week 12) - RMDQ Between-Group Differences in Disability||0.2|-3.2|
72490929|NCT01692275|144509720|SUPERIORITY||Mean Difference (Final Values)|-2.1|||||TWO_SIDED|95.0|-3.8|-0.4||||||Pensacola site (week 6) - RMDQ Between-Group Differences in Disability||-0.4|-3.8|
72490930|NCT01692275|144509720|SUPERIORITY||Mean Difference (Final Values)|-1.9|||||TWO_SIDED|95.0|-3.7|-0.2||||||Pensacola site (week 12) - RMDQ Between-Group Differences in Disability||-0.2|-3.7|
72490931|NCT01692275|144509720|SUPERIORITY||Mean Difference (Final Values)|-2.7|||||TWO_SIDED|95.0|-4.3|-1.1||||||San Diego site (week 6) - RMDQ Between-Group Differences in Disability||-1.1|-4.3|
72490932|NCT01692275|144509720|SUPERIORITY||Mean Difference (Final Values)|-2.7|||||TWO_SIDED|95.0|-4.4|-1.1||||||San Diego site (week 12) - RMDQ Between-Group Differences in Disability||-1.1|-4.4|
72490933|NCT01692275|144509721|SUPERIORITY||Mean Difference (Final Values)|-0.4|||||TWO_SIDED|95.0|-0.6|-0.2||||||All sites combined (week 6) - Between-Group Differences of Means in score of bothersomeness of LBP||-0.2|-0.6|
72490934|NCT01692275|144509721|SUPERIORITY||Mean Difference (Final Values)|-0.4|||||TWO_SIDED|95.0|-0.6|-0.2||||||All sites combined (week 12) - Between-Group Differences of Means in score of bothersomeness of LBP||-0.2|-0.6|
72490935|NCT01692275|144509721|SUPERIORITY||Mean Difference (Final Values)|-0.2|||||TWO_SIDED|95.0|-0.5|0.1||||||Walter Reed site (week 6) - Between-Group Differences of Means in score of bothersomeness of LBP||0.1|-0.5|
72490936|NCT01692275|144509721|SUPERIORITY||Mean Difference (Final Values)|-0.2|||||TWO_SIDED|95.0|-0.5|0.1||||||Walter Reed site (week 12) - Between-Group Differences of Means in score of bothersomeness of LBP||0.1|-0.5|
72569068|NCT04442490|144669300|SUPERIORITY||LS Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|1.05||0.7751|TWO_SIDED|95.0|-1.8|2.4|||MMRM|||Social Functioning Domain Score: Change from Baseline at Day 28||2.4|-1.8|0.7751
72569069|NCT04442490|144669300|SUPERIORITY||LS Mean Difference|1.8|STANDARD_ERROR_OF_MEAN|1.07||0.0913|TWO_SIDED|95.0|-0.3|3.9|||MMRM|||Social Functioning Domain Score: Change from Baseline at Day 42||3.9|-0.3|0.0913
72569070|NCT04442490|144669300|SUPERIORITY||LS Mean Difference|1.1|STANDARD_ERROR_OF_MEAN|1.05||0.2863|TWO_SIDED|95.0|-0.9|3.2|||MMRM|||Role-Emotional Domain Score: Change from Baseline at Day 8||3.2|-0.9|0.2863
72569071|NCT04442490|144669300|SUPERIORITY||LS Mean Difference|1.5|STANDARD_ERROR_OF_MEAN|1.13||0.1801|TWO_SIDED|95.0|-0.7|3.7|||MMRM|||Role-Emotional Domain Score: Change from Baseline at Day 15||3.7|-0.7|0.1801
72569072|NCT04442490|144669300|SUPERIORITY||LS Mean Difference|1.8|STANDARD_ERROR_OF_MEAN|1.16||0.1107|TWO_SIDED|95.0|-0.4|4.1|||MMRM|||Role-Emotional Domain Score: Change from Baseline at Day 28||4.1|-0.4|0.1107
72569073|NCT04442490|144669300|SUPERIORITY||LS Mean Difference|1.2|STANDARD_ERROR_OF_MEAN|1.23||0.3274|TWO_SIDED|95.0|-1.2|3.6|||MMRM|||Role-Emotional Domain Score: Change from Baseline at Day 42||3.6|-1.2|0.3274
72369268|NCT00611026|144248563|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with terms for country and treatment and ranked baseline value as a covariate.||Treatment difference fesoterodine vs placebo at Week 12.||||<0.0001
72369269|NCT00611026|144248563|SUPERIORITY_OR_OTHER|||||||0.0008|TWO_SIDED|||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with terms for country and treatment and ranked baseline value as a covariate.||Treatment difference Tolterodine ER vs Fesoterodine at Week 12.||||0.0008
72569074|NCT04442490|144669300|SUPERIORITY||LS Mean Difference|1.6|STANDARD_ERROR_OF_MEAN|0.93||0.0873|TWO_SIDED|95.0|-0.2|3.4|||MMRM|||Mental Health Domain Score: Change from Baseline at Day 8||3.4|-0.2|0.0873
72569075|NCT04442490|144669300|SUPERIORITY||LS Mean Difference|1.8|STANDARD_ERROR_OF_MEAN|1.05||0.0871|TWO_SIDED|95.0|-0.3|3.9|||MMRM|||Mental Health Domain Score: Change from Baseline at Day 15||3.9|-0.3|0.0871
72569076|NCT04442490|144669300|SUPERIORITY||LS Mean Difference|1.1|STANDARD_ERROR_OF_MEAN|1.12||0.3095|TWO_SIDED|95.0|-1.1|3.3|||MMRM|||Mental Health Domain Score: Change from Baseline at Day 28||3.3|-1.1|0.3095
72569077|NCT04442490|144669300|SUPERIORITY||LS Mean Difference|1.7|STANDARD_ERROR_OF_MEAN|1.17||0.1477|TWO_SIDED|95.0|-0.6|4.0|||MMRM|||Mental Health Domain Score: Change from Baseline at Day 42||4.0|-0.6|0.1477
72569078|NCT04442490|144669301|SUPERIORITY||LS Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.57||0.0828|TWO_SIDED|95.0|-2.1|0.1|||MMRM||Model used was the MMRM with treatment (SAGE-217/placebo), baseline PHQ-9 total score, antidepressant use at baseline (Yes or No), assessment time point, and time point-by-treatment interaction as fixed effects with Unstructured covariance structure.|Change from Baseline at Day 8||0.1|-2.1|0.0828
72569079|NCT04442490|144669301|SUPERIORITY||LS Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|0.62||0.0606|TWO_SIDED|95.0|-2.4|0.1|||MMRM||Model used was the MMRM with treatment (SAGE-217/placebo), baseline PHQ-9 total score, antidepressant use at baseline (Yes or No), assessment time point, and time point-by-treatment interaction as fixed effects with Unstructured covariance structure.|Change from Baseline at Day 15||0.1|-2.4|0.0606
72369270|NCT00611026|144248564|SUPERIORITY_OR_OTHER|||||||0.0576|TWO_SIDED||||||Van Elteren's Test|P-value based on Van Elteren's Test (a stratified Wilcoxon-Mann Whitney test) adjusted by baseline quartile of severe urgency episodes.||"Treatment difference fesoterodine vs placebo at Week 1. Treatment effects estimated by Winsorized means (5% of the tails were censored, ie, replaced with the value at the 5th and 95 percentile, respectively).~If normality assumptions were severely violated (proportion of non normal observations \> 5%) a non-parametric analysis was to be conducted using Van Elteren's test stratified by baseline quartile of the diary variable analyzed."||||0.0576
72369271|NCT00611026|144248564|SUPERIORITY_OR_OTHER|||||||0.223|TWO_SIDED||||||Van Elteren's Test|P-value based on Van Elteren's Test (a stratified Wilcoxon-Mann Whitney test) adjusted by baseline quartile of severe urgency episodes.||Treatment difference Tolterodine ER vs placebo at Week 1. Treatment effects estimated by Winsorized means (5% of the tails were censored, ie, replaced with the value at the 5th and 95 percentile, respectively).||||0.2230
72369272|NCT00611026|144248564|SUPERIORITY_OR_OTHER|||||||0.3555|TWO_SIDED||||||Van Elteren's Test|P-value based on Van Elteren's Test (a stratified Wilcoxon-Mann Whitney test) adjusted by baseline quartile of severe urgency episodes.||Treatment difference fesoterodine vs Tolterodine ER at Week 1. Treatment effects estimated by Winsorized means (5% of the tails were censored, ie, replaced with the value at the 5th and 95 percentile, respectively).||||0.3555
72569080|NCT04442490|144669301|SUPERIORITY||LS Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.63||0.1079|TWO_SIDED|95.0|-2.3|0.2|||MMRM||Model used was the MMRM with treatment (SAGE-217/placebo), baseline PHQ-9 total score, antidepressant use at baseline (Yes or No), assessment time point, and time point-by-treatment interaction as fixed effects with Unstructured covariance structure.|Change from Baseline at Day 28||0.2|-2.3|0.1079
72569081|NCT04442490|144669301|SUPERIORITY||LS Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.66||0.3951|TWO_SIDED|95.0|-1.9|0.7|||MMRM||Model used was the MMRM with treatment (SAGE-217/placebo), baseline PHQ-9 total score, antidepressant use at baseline (Yes or No), assessment time point, and time point-by-treatment interaction as fixed effects with Unstructured covariance structure.|Change from Baseline at Day 42||0.7|-1.9|0.3951
72569082|NCT02227147|144669302|SUPERIORITY||Difference in percentage|40.4|||=|0.006|TWO_SIDED|90.0|14.2|66.6|||Chi-squared|||||66.6|14.2|=0.006
72569083|NCT02227147|144669303|SUPERIORITY||Difference in percentage|36.1|||=|0.013|TWO_SIDED|95.0|9.4|62.7|||Chi-squared|||||62.7|9.4|=0.013
72569084|NCT02227147|144669304|SUPERIORITY||difference in percentage|19.0|||=|0.191|TWO_SIDED|95.0|-9.0|47.1|||Chi-squared|||week 4 - central reviewer||47.1|-9.0|=0.191
72569085|NCT02227147|144669304|SUPERIORITY||difference in percentage|10.7|||=|0.464|TWO_SIDED|95.0|-17.7|39.1|||Chi-squared|||week 6 - central reviewer||39.1|-17.7|=0.464
72569086|NCT02227147|144669304|SUPERIORITY||difference in percentage|14.9|||=|0.308|TWO_SIDED|95.0|-13.4|43.1|||Chi-squared|||week 4 - investigator||43.1|-13.4|=0.308
72369111|NCT00478023|144248220|SUPERIORITY_OR_OTHER_LEGACY||Least square mean difference|37.1|||<|0.0001||95.0|21.6|52.6||Adjusted. The Hochberg procedure used for multiplicity comparisons.|ANCOVA|ANCOVA with treatment and centre as fixed effects and baseline pain as covariate.|Only pain intensity assessments collected prior to the first dose of any additional analgesic medication considered. Afterwards LOCF used.|The null hypothesis is that all CG5503 IR dose groups are equal to the placebo group based on the mean sum of pain intensity difference at 48 hours (SPID48). The alternative hypothesis is that at least one CG5503 IR dose group is different from the placebo group based on the mean SPID48.||52.6|21.6|<0.0001
72404866|NCT00782210|144317130|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.131|STANDARD_ERROR_OF_MEAN|0.037||0.0003||95.0|0.059|0.203|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.203|0.059|0.0003
72490937|NCT01692275|144509721|SUPERIORITY||Mean Difference (Final Values)|-0.5|||||TWO_SIDED|95.0|-0.8|-0.2||||||Pensacola site (week 6) - Between-Group Differences of Means in score of bothersomeness of LBP||-0.2|-0.8|
72490938|NCT01692275|144509721|SUPERIORITY||Mean Difference (Final Values)|-0.5|||||TWO_SIDED|95.0|-0.8|-0.2||||||Pensacola site (week 12) - Between-Group Differences of Means in score of bothersomeness of LBP||-0.2|-0.8|
72490939|NCT01692275|144509721|SUPERIORITY||Mean Difference (Final Values)|-0.5|||||TWO_SIDED|95.0|-0.7|-0.2||||||San Diego site (week 6) - Between-Group Differences of Means in score of bothersomeness of LBP||-0.2|-0.7|
72490940|NCT01692275|144509721|SUPERIORITY||Mean Difference (Final Values)|-0.4|||||TWO_SIDED|95.0|-0.7|-0.1||||||San Diego site (week 12) - Between-Group Differences of Means in score of bothersomeness of LBP||-0.1|-0.7|
72490941|NCT01692275|144509722|SUPERIORITY||Mean Difference (Final Values)|-1.2|||||TWO_SIDED|95.0|-1.6|-0.8||||||All sites combined (week 6) - NRS score for worst LBP in past 24 hours - Between-Group Differences of Mean||-0.8|-1.6|
72490942|NCT01692275|144509722|SUPERIORITY||Mean Difference (Final Values)|-1.1|||||TWO_SIDED|95.0|-1.6|-0.7||||||All sites combined (week 12) - NRS score for worst LBP in past 24 hours - Between-Group Differences of Mean||-0.7|-1.6|
72490943|NCT01692275|144509722|SUPERIORITY||Mean Difference (Final Values)|-0.7|||||TWO_SIDED|95.0|-1.3|-0.02||||||Walter Reed site (week 6) - NRS score for worst LBP in past 24 hours - Between-Group Differences of Mean||-0.02|-1.3|
72490944|NCT01692275|144509722|SUPERIORITY||Mean Difference (Final Values)|-0.8|||||TWO_SIDED|95.0|-1.5|-0.1||||||Walter Reed site (week 12) - NRS score for worst LBP in past 24 hours - Between-Group Differences of Mean||-0.1|-1.5|
72490945|NCT01692275|144509722|SUPERIORITY||Mean Difference (Final Values)|-1.3|||||TWO_SIDED|95.0|-2.0|-0.7||||||Pensacola site (week 6) - NRS score for worst LBP in past 24 hours - Between-Group Differences of Mean||-0.7|-2.0|
72517132|NCT02528253|144564403|SUPERIORITY||LS Mean Difference|-0.33|STANDARD_ERROR_OF_MEAN|0.15||0.029|TWO_SIDED|95.0|-0.63|-0.03|||ANCOVA|||Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with normal work, and baseline average LBPI as covariates, and study site as a random effect.||-0.03|-0.63|0.0290
72490946|NCT01692275|144509722|SUPERIORITY||Mean Difference (Final Values)|-1.5|||||TWO_SIDED|95.0|-2.3|-0.8||||||Pensacola site (week 12) - NRS score for worst LBP in past 24 hours - Between-Group Differences of Mean||-0.8|-2.3|
72490947|NCT01692275|144509722|SUPERIORITY||Mean Difference (Final Values)|-1.6|||||TWO_SIDED|95.0|-2.3|-1.0||||||San Diego site (week 6) - NRS score for worst LBP in past 24 hours - Between-Group Differences of Mean||-1.0|-2.3|
72517133|NCT02528253|144564403|SUPERIORITY||LS Mean Difference|-0.48|STANDARD_ERROR_OF_MEAN|0.15||0.0015|TWO_SIDED|95.0|-0.77|-0.18|||ANCOVA|||Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with normal work, and baseline average LBPI as covariates, and study site as a random effect.||-0.18|-0.77|0.0015
72517134|NCT02528253|144564403|SUPERIORITY||LS Mean Difference|-0.52|STANDARD_ERROR_OF_MEAN|0.18||0.0041|TWO_SIDED|95.0|-0.87|-0.17|||ANCOVA|||Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with normal work, and baseline average LBPI as covariates, and study site as a random effect.||-0.17|-0.87|0.0041
72517135|NCT02528253|144564403|SUPERIORITY||LS Mean Difference|-0.89|STANDARD_ERROR_OF_MEAN|0.18|<|0.0001|TWO_SIDED|95.0|-1.25|-0.54|||ANCOVA|||Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with normal work, and baseline average LBPI as covariates, and study site as a random effect.||-0.54|-1.25|<.0001
72517136|NCT02528253|144564403|SUPERIORITY||LS Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.17||0.1799|TWO_SIDED|95.0|-0.55|0.1|||ANCOVA|||Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with normal work, and baseline average LBPI as covariates, and study site as a random effect.||0.10|-0.55|0.1799
72517137|NCT02528253|144564403|SUPERIORITY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.16||0.0696|TWO_SIDED|95.0|-0.62|0.02|||ANCOVA|||Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with normal work, and baseline average LBPI as covariates, and study site as a random effect.||0.02|-0.62|0.0696
72569087|NCT02227147|144669304|SUPERIORITY||difference in percentage|23.6|||=|0.106|TWO_SIDED|95.0|-4.2|51.3|||Chi-squared|||week 6 - investigator||51.3|-4.2|=0.106
72490948|NCT01692275|144509722|SUPERIORITY||Mean Difference (Final Values)|-1.2|||||TWO_SIDED|95.0|-1.9|-0.5||||||San Diego site (week 12) - NRS score for worst LBP in past 24 hours - Between-Group Differences of Mean||-0.5|-1.9|
72490949|NCT01692275|144509723|SUPERIORITY||Odds Ratio (OR)|0.73|||||TWO_SIDED|95.0|0.54|0.97||||||Week 6: All 3 sites combined||0.97|0.54|
72490950|NCT01692275|144509723|SUPERIORITY||Odds Ratio (OR)|0.76|||||TWO_SIDED|95.0|0.58|1.0||||||Week 12: All 3 sites combined||1.0|0.58|
72490951|NCT01692275|144509724|SUPERIORITY||Odds Ratio (OR)|0.18|||||TWO_SIDED|95.0|0.13|0.25||||||All sites combined: 6 weeks||0.25|0.13|
72490952|NCT01692275|144509724|SUPERIORITY||Odds Ratio (OR)|0.26|||||TWO_SIDED|95.0|0.16|0.42||||||Walter Reed site: 6 weeks||0.42|0.16|
72490953|NCT01692275|144509724|SUPERIORITY||Odds Ratio (OR)|0.18|||||TWO_SIDED|95.0|0.1|0.33||||||Naval Hospital Pensacola site: 6 weeks||0.33|0.10|
72490954|NCT01692275|144509724|SUPERIORITY||Odds Ratio (OR)|0.13|||||TWO_SIDED|95.0|0.08|0.21||||||Naval Medical Center San Diego site: 6 weeks||0.21|0.08|
72490955|NCT01692275|144509725|SUPERIORITY||Mean Difference (Final Values)|2.5|||||TWO_SIDED|95.0|2.1|2.8||||||All sites combined: 6 weeks||2.8|2.1|
72490956|NCT01692275|144509725|SUPERIORITY||Mean Difference (Final Values)|2.0|||||TWO_SIDED|95.0|1.4|2.6||||||Walter Reed site: 6 weeks||2.6|1.4|
72490957|NCT01692275|144509725|SUPERIORITY||Mean Difference (Final Values)|2.3|||||TWO_SIDED|95.0|1.6|3.0||||||Naval Hospital Pensacola site: 6 weeks||3.0|1.6|
72490958|NCT01692275|144509725|SUPERIORITY||Mean Difference (Final Values)|3.1|||||TWO_SIDED|95.0|2.5|3.7||||||Naval Medical Center San Diego site: 6 weeks||3.7|2.5|
72490959|NCT00677014|144509762|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1||||0.66||95.0|||||ANOVA|As LVESV values were non normal by Q-Q analysis and Shapiro-Wilk test (p\<.05), a square root transform was used. model adjusted for baseline LVESV.||Gate keeping strategy utilized for Type 1 error control described in design paper - negative results observed for initial comparisons - (each at alpha = .05) between fixed and algorithm optimized AV delay and fixed and Echo optimzied AV. Results from both of these comparisons were non-significant.||||.66
72490960|NCT02374099|144509790|SUPERIORITY||Hazard Ratio (HR)|0.87|||=|0.599|TWO_SIDED|95.0|0.54|1.42|||Log Rank||||Hazard ratio and associated two-sided 95% confidence intervals (CI) were estimated by the Cox proportional hazard models.|1.42|0.54|= 0.599
72490961|NCT02374099|144509791|SUPERIORITY||Difference in Response Rates|6.3|||=|0.1479|TWO_SIDED|95.0|-2.47|15.06|||Fisher Exact||||The two-sided 95% confidence interval for the difference in ORR was estimated by the Wilson method.|15.06|-2.47|= 0.1479
72517138|NCT02528253|144564403|SUPERIORITY||LS Mean Difference|-0.67|STANDARD_ERROR_OF_MEAN|0.16|<|0.0001|TWO_SIDED|95.0|-0.99|-0.35|||ANCOVA|||Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with normal work, and baseline average LBPI as covariates, and study site as a random effect.||-0.35|-0.99|<.0001
72624647|NCT01346592|144778955|SUPERIORITY_OR_OTHER||GMT ratio (H3N2 strain)|3.1|||||TWO_SIDED|95.0|2.69|3.56||||||superiority was concluded if the lower limit of the confidence interval of the day 50 vaccine group GMT ratios for at least 2 homologous strains was \>1.5||3.56|2.69|
72404867|NCT00782210|144317130|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.141|STANDARD_ERROR_OF_MEAN|0.036||0.0001||95.0|0.069|0.213|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.213|0.069|0.0001
72404868|NCT00782210|144317131|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.115|STANDARD_ERROR_OF_MEAN|0.037||0.0019||95.0|0.043|0.187|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.187|0.043|0.0019
72490962|NCT02374099|144509792|SUPERIORITY||Difference in Clinical Benefit Rate|0.7|||=|0.1732|TWO_SIDED|95.0|-17.76|19.04|||Fisher Exact||||The two-sided 95% confidence interval for the difference in clinical benefit rate was estimated by the Wilson method.|19.04|-17.76|= 0.1732
72490963|NCT02374099|144509793|SUPERIORITY||Hazard Ratio (HR)|0.59|||=|0.2725|TWO_SIDED|95.0|0.23|1.53|||Log Rank||||Hazard Ratio and associated two-sided 95% CI were estimated by the Cox proportional hazard model.|1.53|0.23|= 0.2725
72490964|NCT01033825|144509829|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be demonstrated if the 95% CI upper bound for the difference between ciclesonide and placebo with placebo dexamethasone (placebo minus ciclesonide) is \<Margin. In order to have 90% power to demonstrate non-inferiority of ciclesonide 320 μg to HFA placebo, 46 evaluable subjects per group are needed using a 1-sided alpha level of 0.025, a standard deviation of 55 μg h/dL, a non-inferiority margin of 38 μh /dL, assuming no true difference exists.|Mean Difference (Final Values)|-0.5|||>|0.05|TWO_SIDED|95.0|-13.9|13.0|||ANCOVA||Null Hypothesis: the difference in serum cortisol levels between placebo and active (placebo-active)\>=38 Alternative Hypothesis: the difference in serum cortisol levels between placebo and active (placebo-active)\<38|Standard bioequivalence bounds of a 20% difference based on the clinical judgment was used to determine the delta.||13.0|-13.9|>0.05
72490965|NCT01033825|144509829|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be demonstrated if the 95% CI upper bound for the difference between ciclesonide and placebo with placebo dexamethasone (placebo minus ciclesonide) is \<Margin. In order to have 90% power to demonstrate non-inferiority of ciclesonide 320 μg to HFA placebo, 46 evaluable subjects per group are needed using a 1-sided alpha level of 0.025, a standard deviation of 55 μg h/dL, a non-inferiority margin of 38 μh /dL, assuming no true difference exists.|Mean Difference (Final Values)|-2.4||||0.025|TWO_SIDED|95.0|-15.1|10.2|||ANCOVA|||Standard bioequivalence bounds of a 20% difference based on the clinical judgment was used to determine the delta.||10.2|-15.1|0.025
72490966|NCT01033825|144509829|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be demonstrated if the 95% CI upper bound for the difference between ciclesonide and placebo with placebo dexamethasone (placebo minus ciclesonide) is \<Margin. In order to have 90% power to demonstrate non-inferiority of ciclesonide nasal spray 200 μg to placebo nasal spray 46 evaluable (per protocol) subjects per group are needed using a 1-sided alpha level of 0.025, a standard deviation of 55 μg h/dL, a non-inferiority margin of 38 μh /dL|Mean Difference (Final Values)|10.4|||>|0.05|TWO_SIDED|95.0|-4.7|25.5|||ANCOVA|||Standard bioequivalence bounds of a 20% difference based on the clinical judgment was used to determine the delta.||25.5|-4.7|>0.05
72490967|NCT03449095|144509880|SUPERIORITY||||||<|0.001||||||The reported p-value was calculated, and is not attempting to indicate the threshold for statistical significance.|ANOVA|||||||<0.001
72490968|NCT03449095|144509881|SUPERIORITY|||||||0.001||||||The reported p-value was calculated, and is not attempting to indicate the threshold for statistical significance.|ANCOVA|||||||.001
72490969|NCT00894556|144509923|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||Generalized Linear Mixed Model (GLIMMIX)|An unstructured covariance matrix was used to model the correlation among repeated measurements within patient.||||||<0.001
72624648|NCT01346592|144778955|SUPERIORITY_OR_OTHER||GMT ratio (B strain)|4.64|||||TWO_SIDED|95.0|3.86|5.59||||||superiority was concluded if the lower limit of the confidence interval of the day 50 vaccine group GMT ratios for at least 2 homologous strains was \>1.5||5.59|3.86|
72490970|NCT00894556|144509924|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||Generalized Linear Mixed Model (GLIMMIX)|An unstructured covariance matrix was used to model the correlation among repeated measurements within patient.||||||<0.001
72490971|NCT04294901|144510044|SUPERIORITY||Odds Ratio (OR)|1.21||||0.008|TWO_SIDED|95.0|1.05|1.38|||Mixed Models Analysis|Binary mixed effect model with patients nested in providers nested in facilities||It is pre-specified in the Study Protocol and Statistical Analysis Plan to assess all medication groups combined within the Intervention and Control Arms/Groups.||1.38|1.05|0.008
72404869|NCT00782210|144317131|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.16|STANDARD_ERROR_OF_MEAN|0.037|<|0.0001||95.0|0.088|0.233|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.233|0.088|<0.0001
72490972|NCT02813551|144510059|SUPERIORITY||Risk Ratio (RR)|0.76|||||TWO_SIDED|95.0|0.53|1.1||||||||1.10|0.53|
72490973|NCT02813551|144510060|SUPERIORITY||Risk Ratio (RR)|1.2|||||TWO_SIDED|95.0|0.4|3.3||||||||3.3|0.4|
72490974|NCT02813551|144510061|SUPERIORITY||Risk Ratio (RR)|3.0|||||TWO_SIDED|95.0|0.3|28.0||||||||28|0.3|
72490975|NCT02813551|144510062|SUPERIORITY||Risk Ratio (RR)|1.1|||||TWO_SIDED|95.0|1.0|1.3||||||||1.3|1.0|
72490976|NCT02813551|144510065|SUPERIORITY||Risk Ratio (RR)|1.1|||||TWO_SIDED|95.0|1.0|1.2||||||||1.2|1.0|
72517139|NCT02528253|144564403|SUPERIORITY||LS Mean Difference|-0.38|STANDARD_ERROR_OF_MEAN|0.18||0.0387|TWO_SIDED|95.0|-0.74|-0.02|||ANCOVA|||Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with normal work, and baseline average LBPI as covariates, and study site as a random effect.||-0.02|-0.74|0.0387
72517140|NCT02528253|144564403|SUPERIORITY||LS Mean Difference|-0.64|STANDARD_ERROR_OF_MEAN|0.18||0.0005|TWO_SIDED|95.0|-1.0|-0.28|||ANCOVA|||Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with normal work, and baseline average LBPI as covariates, and study site as a random effect.||-0.28|-1.00|0.0005
72517141|NCT02528253|144564403|SUPERIORITY||LS Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.17||0.2768|TWO_SIDED|95.0|-0.51|0.15|||ANCOVA|||Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with normal work, and baseline average LBPI as covariates, and study site as a random effect.||0.15|-0.51|0.2768
72517142|NCT02528253|144564403|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.17||0.2408|TWO_SIDED|95.0|-0.53|0.13|||ANCOVA|||Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with normal work, and baseline average LBPI as covariates, and study site as a random effect.||0.13|-0.53|0.2408
72569088|NCT02227147|144669305|SUPERIORITY||difference in percentage|9.5|||=|0.255|TWO_SIDED|95.0|-6.9|25.9|||Chi-squared|||week 4||25.9|-6.9|=0.255
72404870|NCT00782210|144317132|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.13|STANDARD_ERROR_OF_MEAN|0.037||0.0005||95.0|0.057|0.203|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.203|0.057|0.0005
72490977|NCT02813551|144510066|SUPERIORITY||Risk Ratio (RR)|1.0|||||TWO_SIDED|95.0|0.5|1.9||||||||1.9|0.5|
72490978|NCT02813551|144510067|SUPERIORITY||Risk Ratio (RR)|0.4|||||TWO_SIDED|95.0|0.1|2.9||||||||2.9|0.1|
72490979|NCT02909985|144510075|SUPERIORITY||F|23.68|||<|0.0001|TWO_SIDED||||||ANOVA|(9, 129)||||||<0.0001
72569089|NCT02227147|144669305|SUPERIORITY||difference in percentage|0.8|||=|0.927|TWO_SIDED|95.0|-15.6|17.1|||Chi-squared|||week 6||17.1|-15.6|=0.927
72490980|NCT02909985|144510075|SUPERIORITY||F|9.4394|||<|0.0001|TWO_SIDED||||||ANOVA|(11, 52)||||||<0.0001
72490981|NCT04649255|144510081|OTHER||Exact binomial|96.4|||<|0.025|TWO_SIDED|95.0|96.4|100.0|||One-sided exact binomial test|Exact binomial one-sided lower 97.5% CI for performance goal test \>72% for primary effectiveness and \>82% for primary safety.||Descriptive assessment; H0: Ps ≤ PGS, versus HA: PS \> PGS, where where Ps is the population primary safety success rate in the Test group and PGS is the safety performance goal of 82%.||100|96.4|<0.025
72490982|NCT04649255|144510082|OTHER||Exact binomial|89.1|||<|0.025|TWO_SIDED|95.0|89.1|97.5|||One-sided exact binomial test|Exact binomial one-sided lower 97.5% CI for performance goal test \>72% for primary effectiveness and \>82% for primary safety.||Descriptive assessment; H0: PE ≤ PGE, versus HA: PE \> PGE, where PE is the proportion of target lesions with clinical success and PGE is the effectiveness performance goal of 72%.||97.5|89.1|<0.025
72490983|NCT01908101|144510178|OTHER|comparison analysis|Median Difference (Final Values)|3.5|||||TWO_SIDED|95.0|2.6|4.6||comparison analysis; no P value|||The estimated value is 3.5 months, not years.|Progression free survival (PFS). We hypothesize that metronomic dosing of eribulin will result in a PFS of 4-6 months.||4.6|2.6|
72490984|NCT00166205|144510179|SUPERIORITY_OR_OTHER||Percent of ITT subjects|69.6||||||95.0|63.8|74.9||||||A sample size of 215, the adverse event (AE) rate at three years could be estimated with precision as determined by the interval half-width of approximately ± 7%.||74.9|63.8|
72490985|NCT00166205|144510180|SUPERIORITY_OR_OTHER||Mean|75.7|STANDARD_DEVIATION|39.8||||95.0|70.5|80.8||||||||80.8|70.5|
72490986|NCT00166205|144510181|SUPERIORITY_OR_OTHER||Mean|35.7|STANDARD_DEVIATION|6.2||||95.0|34.9|36.5||||||||36.5|34.9|
72490987|NCT00166205|144510182|SUPERIORITY_OR_OTHER||Mean|51.3|STANDARD_DEVIATION|45.8||||95.0|47.6|54.9||||||||54.9|47.6|
72490988|NCT00166205|144510183|SUPERIORITY_OR_OTHER||Mean Difference (Net)|10.4|STANDARD_DEVIATION|10.3||||95.0|9.2|11.7|||||Value at 36 months minus value at baseline. Positive values indicate improved Quality of Life (QOL)|||11.7|9.2|
72490989|NCT00166205|144510184|SUPERIORITY_OR_OTHER||Mean|5.7|STANDARD_DEVIATION|0.7||||95.0|5.6|5.8||||||||5.8|5.6|
72490990|NCT00166205|144510186|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 1 sided|||A one-sided paired t-test would have 80% power to reject the null hypothesis in favor of the alternative (i.e., that the SAGB system is not inferior to the clinically meaningful result of 36.2 for 224 subjects) assuming: a standard deviation (SD) of (21.6), an equivalent limit difference of (3.6), and a significance level of 0.05.||||<0.001
72490991|NCT00166205|144510187|SUPERIORITY_OR_OTHER||Mean|56.4|STANDARD_DEVIATION|14.7||||95.0|54.5|58.4||||||||58.4|54.5|
72490992|NCT00166205|144510188|SUPERIORITY_OR_OTHER||Mean|114.5|STANDARD_DEVIATION|32.3||||95.0|110.1|118.8||||||||118.8|110.1|
72569090|NCT02227147|144669305|SUPERIORITY||difference in percentage|18.6|||=|0.062|TWO_SIDED|95.0|-0.7|37.8|||Chi-squared|||week 8||37.8|-0.7|=0.062
72569091|NCT02227147|144669306|SUPERIORITY||difference in least square means|1.1|||=|0.745|TWO_SIDED|95.0|-5.6|7.7|||ANCOVA|||||7.7|-5.6|=0.745
72569092|NCT02227147|144669307|SUPERIORITY||difference in percentage|-3.8|||=|0.672|TWO_SIDED|95.0|-21.3|13.7|||Chi-squared|||week 4||13.7|-21.3|=0.672
72569093|NCT02227147|144669307|SUPERIORITY||difference in percentage|0.5|||=|0.955|TWO_SIDED|95.0|-18.5|19.6|||Chi-squared|||week 6||19.6|-18.5|=0.955
72569094|NCT02227147|144669307|SUPERIORITY||difference in percentage|-3.6|||=|0.727|TWO_SIDED|95.0|-23.9|16.7|||Chi-squared|||week 8||16.7|-23.9|=0.727
72569095|NCT02227147|144669308|SUPERIORITY||least square mean difference|0.6|||=|0.207|TWO_SIDED|95.0|-0.4|1.5|||ANCOVA|||||1.5|-0.4|=0.207
72569096|NCT02227147|144669309|SUPERIORITY||difference in percentage|-13.3|||=|0.11|TWO_SIDED|95.0|-30.5|3.9|||Chi-squared|||||3.9|-30.5|=0.110
72569097|NCT03514641|144669310|SUPERIORITY||LS Means difference|-2.72||||0.0025|TWO_SIDED|95.0|-4.47|-0.96|||Covariance|Covariance model diabetes status, eGFR at screening, pre-treatment status, treatment, and baseline 24-hour mean SBP||||-0.96|-4.47|0.0025
72569098|NCT03514641|144669311|SUPERIORITY||Mean Difference (Final Values)|-2.43||||0.0117|TWO_SIDED|95.0|-4.32|-0.54|||Covariance|Covariance model diabetes status, eGFR at screening, pre-treatment status, treatment, and baseline 24-hour mean SBP||||-0.54|-4.32|0.0117
72569099|NCT03514641|144669312|SUPERIORITY||Odds Ratio (OR)|1.3||||0.1317|TWO_SIDED|95.0|0.92|1.83||Covariance model diabetes status, eGFR at screening, pre-treatment status, treatment, and baseline 24-hour mean SBP|Covariance|||||1.83|0.92|0.1317
72569100|NCT03514641|144669313|SUPERIORITY||Odds Ratio (OR)|1.6||||0.0113|TWO_SIDED|95.0|1.11|2.3|||Covariance|Covariance model diabetes status, eGFR at screening, pre-treatment status, treatment, and baseline 24-hour mean SBP||||2.30|1.11|0.0113
72569101|NCT03514641|144669314|SUPERIORITY||Mean Difference (Final Values)|-4.63|||<|0.0001|TWO_SIDED|95.0|-6.83|-2.42|||Covariance|Covariance model diabetes status, eGFR at screening, pre-treatment status, treatment, and baseline 24-hour mean SBP||||-2.42|-6.83|<0.0001
72569102|NCT03514641|144669315|SUPERIORITY||Odds Ratio (OR)|1.86||||0.0004|TWO_SIDED|95.0|1.32|2.62|||Covariance|Covariance model diabetes status, eGFR at screening, pre-treatment status, treatment, and baseline 24-hour mean SBP||||2.62|1.32|0.0004
72569103|NCT03514641|144669316|SUPERIORITY||Mean Difference (Final Values)|-0.83||||0.0863|TWO_SIDED|95.0|-1.79|0.12|||Covariance|Covariance model diabetes status, eGFR at screening, pre-treatment status, treatment, and baseline 24-hour mean SBP||||0.12|-1.79|0.0863
72369273|NCT00611026|144248564|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Van Elteren's Test|P-value based on Van Elteren's Test (a stratified Wilcoxon-Mann Whitney test) adjusted by baseline quartile of severe urgency episodes.||Treatment difference fesoterodine vs placebo at Week 4. Treatment effects estimated by Winsorized means (5% of the tails were censored, ie, replaced with the value at the 5th and 95 percentile, respectively).||||<0.0001
72369274|NCT00611026|144248564|SUPERIORITY_OR_OTHER|||||||0.0009|TWO_SIDED||||||Van Elteren's Test|P-value based on Van Elteren's Test (a stratified Wilcoxon-Mann Whitney test) adjusted by baseline quartile of severe urgency episodes.||Treatment difference Tolterodine ER vs placebo at Week 4. Treatment effects estimated by Winsorized means (5% of the tails were censored, ie, replaced with the value at the 5th and 95 percentile, respectively).||||0.0009
72490993|NCT00166205|144510189|SUPERIORITY_OR_OTHER||Mean|193.5|STANDARD_DEVIATION|36.9||||95.0|188.6|198.4||||||||198.4|188.6|
72490994|NCT03187769|144510204|SUPERIORITY||Least Squares Mean Difference|-1.87||||0.012|TWO_SIDED|95.0|-3.33|-0.41|||ANCOVA|||||-.41|-3.33|.012
72490995|NCT00879229|144510223|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-29.0|STANDARD_ERROR_OF_MEAN|67.0||0.696|TWO_SIDED|95.0|-54.0|17.0||This is an exact Wilcoxon rank sum test p-value for testing equality of ambrisentan and placebo distributions.|Wilcoxon (Mann-Whitney)|||||17|-54|0.696
72490996|NCT01097746|144510234|SUPERIORITY||Hazard Ratio (HR)|1.71||||0.33|TWO_SIDED|95.0|0.58|4.98|||t-test, 2 sided|||Participants for optimal ≤ 1 cm||4.98|0.58|0.33
72490997|NCT01097746|144510234|SUPERIORITY||Hazard Ratio (HR)|3.75||||0.04|TWO_SIDED|95.0|1.05|13.34|||t-test, 2 sided|||suboptimal \> 1 cm||13.34|1.05|0.04
72490998|NCT00631371|144510255|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.1||||0.8|TWO_SIDED|95.0|0.9|1.3|||Log Rank|||P value was based on 1-sided stratified log-rank test (stratification factors: prior nephrectomy \[yes/no\] and Memorial Sloan Kettering Cancer Center \[MSKCC\] risk factors \[good/intermediate/poor\] at time of randomization). The hazard ratio and corresponding 95 percent (%) confidence interval (CI) from the stratified cox proportional hazard model were also presented.||1.3|0.9|0.8
72490999|NCT00631371|144510256|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.1||||0.9|TWO_SIDED|95.0|1.0|1.4|||Log Rank|||P-value was based on 1-sided stratified log-rank test (stratification factors: prior nephrectomy \[yes/no\] and MSKCC risk factors \[good/intermediate/poor\] at time of randomization). The hazard ratio and corresponding 95% CI from the stratified cox proportional hazard model were also presented.||1.4|1.0|0.9
72491000|NCT00631371|144510257|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.0||||1|TWO_SIDED|95.0|0.8|1.3|||Cochran-Mantel-Haenszel|||P-value (2-sided), risk ratio and associated 95% CI were based on Cochran-Mantel-Haenszel test stratified by prior nephrectomy and MSKCC risk group as randomized.||1.3|0.8|1.0
72491001|NCT00631371|144510258|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.0||||0.6|TWO_SIDED|95.0|0.9|1.3|||Log Rank|||P value was based on 1-sided stratified log-rank test (stratification factors: prior nephrectomy \[yes/no\] and MSKCC risk factors \[good/intermediate/poor\] at time of randomization). The hazard ratio and corresponding 95% CI from the stratified cox proportional hazard model were also presented.||1.3|0.9|0.6
72491002|NCT00812214|144510272|SUPERIORITY|For the purpose of the power calculation, it was assumed that the difference in total sleep time between the treatment groups is 40 minutes, with a standard deviation of 60. The pilot nature of the study allowed the use of alpha = 0.05 and beta = 0.2, with two-sided comparison, generating a required sample size of 37 subjects per arm.||||||0.33|||||||t-test, 2 sided|two-tailed student's t-test for independent samples||The null hypothesis is that there is no difference in the 6 week average total sleep time||||0.33
72569104|NCT03514641|144669317|SUPERIORITY||Odds Ratio (OR)|1.48||||0.0232|TWO_SIDED|95.0|1.06|2.08|||Covariance|Covariance model diabetes status, eGFR at screening, pre-treatment status, treatment, and baseline 24-hour mean SBP||||2.08|1.06|0.0232
72569105|NCT03514641|144669318|SUPERIORITY||Odds Ratio (OR)|1.81||||0.014|TWO_SIDED|95.0|1.13|2.91|||Covariance|Covariance model diabetes status, eGFR at screening, pre-treatment status, treatment, and baseline 24-hour mean SBP||||2.91|1.13|0.0140
72404871|NCT00782210|144317132|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.162|STANDARD_ERROR_OF_MEAN|0.037|<|0.0001||95.0|0.089|0.235|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.235|0.089|<0.0001
72404872|NCT00782210|144317133|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.083|STANDARD_ERROR_OF_MEAN|0.037||0.0261||95.0|0.01|0.156|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.156|0.010|0.0261
72404873|NCT00782210|144317133|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.123|STANDARD_ERROR_OF_MEAN|0.037||0.001||95.0|0.05|0.197|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.197|0.050|0.0010
72404874|NCT00782210|144317134|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.091|STANDARD_ERROR_OF_MEAN|0.038||0.0154||95.0|0.018|0.165|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.165|0.018|0.0154
72404875|NCT00782210|144317134|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.123|STANDARD_ERROR_OF_MEAN|0.038||0.0011||95.0|0.049|0.197|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.197|0.049|0.0011
72569106|NCT03514641|144669319|SUPERIORITY||Mean Difference (Final Values)|-2.31||||0.0011|TWO_SIDED|95.0|-3.7|-0.92|||Covariance|Covariance model diabetes status, eGFR at screening, pre-treatment status, treatment, and baseline 24-hour mean SBP||||-0.92|-3.70|0.0011
72569107|NCT03514641|144669320|SUPERIORITY||Odds Ratio (OR)|1.63||||0.0094|TWO_SIDED|95.0|1.13|2.35|||Covariance|Covariance model diabetes status, eGFR at screening, pre-treatment status, treatment, and baseline 24-hour mean SBP||||2.35|1.13|0.0094
72569108|NCT03514641|144669321|SUPERIORITY||Mean Difference (Final Values)|-3.2||||0.0083|TWO_SIDED|95.0|-5.57|-0.83|||Covariance|Covariance model diabetes status, eGFR at screening, pre-treatment status, treatment, and baseline 24-hour mean SBP||||-0.83|-5.57|0.0083
72569109|NCT03514641|144669322|SUPERIORITY||Mean Difference (Final Values)|-0.84||||0.1085|TWO_SIDED|95.0|-1.87|0.19|||Covariance|Covariance model diabetes status, eGFR at screening, pre-treatment status, treatment, and baseline 24-hour mean SBP||||0.19|-1.87|0.1085
72404876|NCT00782210|144317135|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.131|STANDARD_ERROR_OF_MEAN|0.038||0.0006||95.0|0.057|0.205|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.205|0.057|0.0006
72404877|NCT00782210|144317135|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.154|STANDARD_ERROR_OF_MEAN|0.038|<|0.0001||95.0|0.08|0.229|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.229|0.080|<0.0001
72404878|NCT00782210|144317136|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.094|STANDARD_ERROR_OF_MEAN|0.038||0.0134||95.0|0.019|0.168|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.168|0.019|0.0134
72404879|NCT00782210|144317136|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.115|STANDARD_ERROR_OF_MEAN|0.038||0.0025||95.0|0.04|0.19|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.190|0.040|0.0025
72491003|NCT00812214|144510273|SUPERIORITY|||||||0.03|||||||t-test, 2 sided|||The null hypothesis is that there is no difference between the eszopiclone and placebo groups in the number of awakenings/night at 6 weeks.||||0.03
72491004|NCT00812214|144510275|SUPERIORITY|||||||0.1|||||||t-test, 2 sided|||Null hypothesis is that there is no difference between Eszopiclone and placebo groups in sleep quality averaged over 6 weeks of treatment.||||0.1
72491005|NCT00812214|144510275|SUPERIORITY|||||||0.29|||||||t-test, 2 sided|||Null hypothesis is that there is no difference between Eszopiclone and placebo groups in daytime alertness averaged over 6 weeks of treatment.||||0.29
72491006|NCT00812214|144510275|SUPERIORITY|||||||0.05|||||||t-test, 2 sided|||Null hypothesis is that there is no difference between Eszopiclone and placebo groups in daytime fatigue averaged over 6 weeks of treatment.||||0.05
72491007|NCT00812214|144510275|SUPERIORITY|||||||0.76|||||||t-test, 2 sided|||Null hypothesis is that there is no difference between Eszopiclone and placebo groups in daytime functioning averaged over 6 weeks of treatment.||||0.76
72491008|NCT00812214|144510277|SUPERIORITY|||||||0.89|||||||t-test, 2 sided|||The null hypothesis is that there is no difference in average days/week between eszopiclone and placebo groups at 6 weeks.||||0.89
72491009|NCT00812214|144510278|SUPERIORITY|||||||0.98|||||||t-test, 2 sided|||The null hypothesis is that there is no difference in headache duration between eszopiclone and placebo groups at 6 weeks.||||0.98
72491010|NCT00812214|144510279|SUPERIORITY|||||||0.82|||||||t-test, 2 sided|||The null hypothesis is that there is no difference in headache intensity between eszopiclone and placebo groups at 6 weeks.||||0.82
72491011|NCT00129766|144510282|NON_INFERIORITY_OR_EQUIVALENCE|Confidence interval and relative risk adjusted for the stratification factor of presence or absence of CLD of prematurity as specified on the CRF.|Risk Ratio (RR)|0.74|||||TWO_SIDED|95.0|0.503|1.083|||t-test, 2 sided||Relative risk was calculated as (Pn/Ps) where Pn is the proportion of patients with RSV hospitalization in the motavizumab group and Ps is the proportion of patients with RSV hospitalization in the palivizumab group.|ITT population||1.083|0.503|
72491012|NCT00129766|144510291|NON_INFERIORITY_OR_EQUIVALENCE|A CMH approach stratified by presence or absence of CLD of prematurity requiring medical intervention was used.||||||0.11||95.0||||Test stratified by presence or absence of CLD of prematurity specified on the CRF|Cochran-Mantel-Haenszel|||||||0.110
72491013|NCT00129766|144510292|NON_INFERIORITY_OR_EQUIVALENCE|A CMH approach stratified by presence or absence of CLD of prematurity requiring medical intervention was used.||||||0.005||95.0||||No adjustment for multiple comparisons.|Cochran-Mantel-Haenszel|The CMH test was stratified by presence or absence of CLD of prematurity as specified on the CRF||||||0.005
72491014|NCT00129766|144510293|NON_INFERIORITY_OR_EQUIVALENCE|A CMH approach stratified by presence or absence of CLD of prematurity requiring medical intervention was used.||||||0.476||95.0|||||Van Eleteren test|Test stratified by presence or absence of CLD of prematurity specified on the CRF||P-value is for overall incidence||||0.476
72491015|NCT00129766|144510294|NON_INFERIORITY_OR_EQUIVALENCE|A CMH approach stratified by presence or absence of CLD of prematurity requiring medical intervention was used.||||||0.493||95.0||||Test stratified by presence or absence of CLD of prematurity specified on the CRF|Van Eleteren test|||||||0.493
72491016|NCT00129766|144510295|NON_INFERIORITY_OR_EQUIVALENCE|A CMH approach stratified by presence or absence of CLD of prematurity requiring medical intervention was used.||||||0.652||95.0||||Test stratified by presence or absence of CLD of prematurity specified on the CRF|Van Eleteren test|||||||0.652
72491017|NCT04091087|144510305|SUPERIORITY||Least square (LS) mean difference|-14.36|STANDARD_ERROR_OF_MEAN|7.47||0.0299|TWO_SIDED|90.0|-26.87|-1.86||1-sided|ANOVA|||||-1.86|-26.87|0.0299
72491018|NCT04091087|144510306|SUPERIORITY||Difference in percentage of participants|3.33||||0.1546|TWO_SIDED|90.0|-2.06|8.72||1-sided|Normal approximation test|||||8.72|-2.06|0.1546
72491019|NCT04091087|144510307|SUPERIORITY||Difference in percentage of participants|9.0||||0.0819|TWO_SIDED|90.0|-1.63|19.62||1-sided|Normal approximation test|||Week 1||19.62|-1.63|0.0819
72491020|NCT04091087|144510307|SUPERIORITY||Difference in percentage of participants|-0.47||||0.4789|TWO_SIDED|90.0|-15.2|14.25||1-sided|Normal approximation test|||Week 2||14.25|-15.20|0.4789
72491021|NCT04091087|144510307|SUPERIORITY||Difference in percentage of participants|-0.38||||0.4815|TWO_SIDED|90.0|-13.79|13.03||1-sided|Normal approximation test|||Week 3||13.03|-13.79|0.4815
72491022|NCT04091087|144510307|SUPERIORITY||Difference in percentage of participants|-0.38||||0.4815|TWO_SIDED|90.0|-13.79|13.03||1-sided|Normal approximation test|||Week 4||13.03|-13.79|0.4815
72491023|NCT04091087|144510307|SUPERIORITY||Difference in percentage of participants|8.9||||0.1197|TWO_SIDED|90.0|-3.55|21.35||1-sided|Normal approximation test|||Week 5||21.35|-3.55|0.1197
72491024|NCT04091087|144510307|SUPERIORITY||Difference in percentage of participants|18.18||||0.0034|TWO_SIDED|90.0|7.14|29.23||1-sided|Normal approximation test|||Week 6||29.23|7.14|0.0034
72491025|NCT04091087|144510308|SUPERIORITY||Difference in percentage of participants|5.13||||0.2896|TWO_SIDED|90.0|-10.09|20.34||1-sided|Normal approximation test|||||20.34|-10.09|0.2896
72491026|NCT04091087|144510309|SUPERIORITY||Difference in percentage of participants|7.77||||0.2648|TWO_SIDED|90.0|-12.55|28.08||1-sided|Normal approximation test|||Week 1||28.08|-12.55|0.2648
72491027|NCT04091087|144510309|SUPERIORITY||Difference in percentage of participants|17.05||||0.0809|TWO_SIDED|90.0|-2.99|37.08||1-sided|Normal approximation test|||Week 2||37.08|-2.99|0.0809
72491028|NCT04091087|144510309|SUPERIORITY||Difference in percentage of participants|1.7||||0.445|TWO_SIDED|90.0|-18.58|21.99||1-sided|Normal approximation test|||Week 3||21.99|-18.58|0.4450
72491029|NCT04091087|144510309|SUPERIORITY||Difference in percentage of participants|1.7||||0.445|TWO_SIDED|90.0|-18.58|21.99||1-sided|Normal approximation test|||Week 4||21.99|-18.58|0.4450
72491030|NCT04091087|144510309|SUPERIORITY||Difference in percentage of participants|20.45||||0.0385|TWO_SIDED|90.0|1.43|39.48||1-sided|Normal approximation test|||Week 5||39.48|1.43|0.0385
72491031|NCT04091087|144510309|SUPERIORITY||Difference in percentage of participants|29.64||||0.0045|TWO_SIDED|90.0|10.95|48.33||1 sided|Normal approximation test|||Week 6||48.33|10.95|0.0045
72491032|NCT04091087|144510310|SUPERIORITY||LS mean Difference|3.88|STANDARD_ERROR_OF_MEAN|13.49||0.3874|TWO_SIDED|90.0|-18.67|26.43||1-sided|Normal approximation test|||Week 1||26.43|-18.67|0.3874
72491033|NCT04091087|144510310|SUPERIORITY||LS mean Difference|-4.47|STANDARD_ERROR_OF_MEAN|11.59||0.3506|TWO_SIDED|90.0|-23.85|14.91||1-sided|Normal approximation test|||Week 2||14.91|-23.85|0.3506
72491034|NCT04091087|144510310|SUPERIORITY||LS mean Difference|9.81|STANDARD_ERROR_OF_MEAN|14.23||0.2466|TWO_SIDED|90.0|-13.97|33.6||1-sided|Normal approximation test|||Week 3||33.60|-13.97|0.2466
72491035|NCT04091087|144510310|SUPERIORITY||LS mean Difference|34.74|STANDARD_ERROR_OF_MEAN|15.74||0.0157|TWO_SIDED|90.0|8.43|61.05||1-sided|Normal approximation test|||Week 4||61.05|8.43|0.0157
72491036|NCT04091087|144510310|SUPERIORITY||LS mean Difference|-1.66|STANDARD_ERROR_OF_MEAN|14.55||0.4548|TWO_SIDED|90.0|-25.99|22.68||1-sided|Normal approximation test|||Week 5||22.68|-25.99|0.4548
72569110|NCT03514641|144669323|SUPERIORITY||Mean Difference (Final Values)|-1.25||||0.0837|TWO_SIDED|95.0|-2.67|0.17|||Covariance|Covariance model diabetes status, eGFR at screening, pre-treatment status, treatment, and baseline 24-hour mean SBP||||0.17|-2.67|0.0837
72369275|NCT00611026|144248564|SUPERIORITY_OR_OTHER|||||||0.0071|TWO_SIDED||||||Van Elteren's Test|P-value based on Van Elteren's Test (a stratified Wilcoxon-Mann Whitney test) adjusted by baseline quartile of severe urgency episodes.||Treatment difference fesoterodine vs Tolterodine ER at Week 4. Treatment effects estimated by Winsorized means (5% of the tails were censored, ie, replaced with the value at the 5th and 95 percentile, respectively).||||0.0071
72369276|NCT00611026|144248564|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Van Elteren's Test|P-value based on Van Elteren's Test (a stratified Wilcoxon-Mann Whitney test) adjusted by baseline quartile of severe urgency episodes.||Treatment difference fesoterodine vs placebo at Week 12. Treatment effects estimated by Winsorized means (5% of the tails were censored, ie, replaced with the value at the 5th and 95 percentile, respectively).||||<0.0001
72517143|NCT02528253|144564403|SUPERIORITY||LS Mean Difference|-0.46|STANDARD_ERROR_OF_MEAN|0.17||0.0064|TWO_SIDED|95.0|-0.78|-0.13|||ANCOVA|||Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with normal work, and baseline average LBPI as covariates, and study site as a random effect.||-0.13|-0.78|0.0064
72517144|NCT02528253|144564403|SUPERIORITY||LS Mean Difference|-0.51|STANDARD_ERROR_OF_MEAN|0.2||0.0115|TWO_SIDED|95.0|-0.9|-0.11|||ANCOVA|||Change at Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with normal work, and baseline average LBPI as covariates, and study site as a random effect.||-0.11|-0.90|0.0115
72517145|NCT02528253|144564403|SUPERIORITY||LS Mean Difference|-0.69|STANDARD_ERROR_OF_MEAN|0.2||0.0006|TWO_SIDED|95.0|-1.08|-0.29|||ANCOVA|||Change at Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with normal work, and baseline average LBPI as covariates, and study site as a random effect.||-0.29|-1.08|0.0006
72517146|NCT02528253|144564403|SUPERIORITY||LS Mean Difference|-0.23|STANDARD_ERROR_OF_MEAN|0.18||0.2028|TWO_SIDED|95.0|-0.59|0.13|||ANCOVA|||Change at Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with normal work, and baseline average LBPI as covariates, and study site as a random effect.||0.13|-0.59|0.2028
72517147|NCT02528253|144564403|SUPERIORITY||LS Mean Difference|-0.28|STANDARD_ERROR_OF_MEAN|0.18||0.1351|TWO_SIDED|95.0|-0.64|0.09|||ANCOVA|||Change at Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with normal work, and baseline average LBPI as covariates, and study site as a random effect.||0.09|-0.64|0.1351
72569111|NCT01055132|144669343|NON_INFERIORITY_OR_EQUIVALENCE|Based on historical data, a minimum of 42 subjects is needed to achieve 80% power with 0.05 type I error.|Least-square mean difference|-0.037|STANDARD_ERROR_OF_MEAN|0.0072|||TWO_SIDED|95.0|-0.041|-0.0013|||linear mixed model|Sequence of wear, period and lens were included as fixed effects; site, patient, eye\*patient, period\*patient and period\*eye\*patient as random effects.|Comparison between study lenses was carried out using 2-sided 95% confidence interval of the least-square mean difference(test minus control). The non-inferiority was concluded if the upper limit of the confidence limit is below 0.05 LogMAR.|Ho:The test lens is non-inferior to the active comparator lens for monocular visual performance on logMAR scale at 1-week follow-up. A non-inferiority margin of 0.05 logMAR was used.||-0.0013|-0.041|
72369277|NCT00611026|144248564|SUPERIORITY_OR_OTHER|||||||0.1764|TWO_SIDED||||||Van Elteren's Test|P-value based on Van Elteren's Test (a stratified Wilcoxon-Mann Whitney test) adjusted by baseline quartile of severe urgency episodes.||Treatment difference Tolterodine ER vs placebo at Week 12. Treatment effects estimated by Winsorized means (5% of the tails were censored, ie, replaced with the value at the 5th and 95 percentile, respectively).||||0.1764
72369278|NCT00611026|144248564|SUPERIORITY_OR_OTHER|||||||0.0001|TWO_SIDED||||||Van Elteren's Test|P-value based on Van Elteren's Test (a stratified Wilcoxon-Mann Whitney test) adjusted by baseline quartile of severe urgency episodes.||Treatment difference fesoterodine vs Tolterodine ER at Week 12. Treatment effects estimated by Winsorized means (5% of the tails were censored, ie, replaced with the value at the 5th and 95 percentile, respectively).||||0.0001
72369279|NCT00611026|144248565|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with terms for country and treatment and ranked baseline value as a covariate.||Treatment difference fesoterodine vs placebo at Week 4.||||<0.0001
72369280|NCT00611026|144248565|SUPERIORITY_OR_OTHER|||||||0.0003|TWO_SIDED|||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with terms for country and treatment and ranked baseline value as a covariate.||Treatment difference Tolterodine ER vs placebo at Week 4.||||0.0003
72369281|NCT00611026|144248565|SUPERIORITY_OR_OTHER|||||||0.0302|TWO_SIDED|||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with terms for country and treatment and ranked baseline value as a covariate.||Treatment difference Tolterodine ER vs Fesoterodine at Week 4.||||0.0302
72369282|NCT00611026|144248565|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with terms for country and treatment and ranked baseline value as a covariate.||Treatment difference fesoterodine vs placebo at Week 12.||||<0.0001
72491037|NCT04091087|144510310|SUPERIORITY||LS mean Difference|-42.19|STANDARD_ERROR_OF_MEAN|11.99||0.0004|TWO_SIDED|90.0|-62.24|-22.15||1-sided|Normal approximation test|||Week 6||-22.15|-62.24|0.0004
72491038|NCT04091087|144510311|SUPERIORITY||LS mean difference|6.91|STANDARD_ERROR_OF_MEAN|9.65||0.2383|TWO_SIDED|90.0|-9.23|23.06||1 sided|ANOVA|||||23.06|-9.23|0.2383
72491039|NCT04091087|144510312|SUPERIORITY||LS mean Difference|-29.95|STANDARD_ERROR_OF_MEAN|21.01||0.0797|TWO_SIDED|90.0|-65.09|5.18||1-sided|Normal approximation test|||Week 1||5.18|-65.09|0.0797
72491040|NCT04091087|144510312|SUPERIORITY||LS mean Difference|-14.39|STANDARD_ERROR_OF_MEAN|18.79||0.2236|TWO_SIDED|90.0|-45.81|17.04||1-sided|Normal approximation test|||Week 2||17.04|-45.81|0.2236
72369283|NCT00611026|144248565|SUPERIORITY_OR_OTHER|||||||0.0007|TWO_SIDED|||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with terms for country and treatment and ranked baseline value as a covariate.||Treatment difference Tolterodine ER vs Fesoterodine at Week 12.||||0.0007
72491041|NCT04091087|144510312|SUPERIORITY||LS mean Difference|-9.94|STANDARD_ERROR_OF_MEAN|15.05||0.2559|TWO_SIDED|90.0|-35.12|15.24||1-sided|Normal approximation test|||Week 3||15.24|-35.12|0.2559
72491042|NCT04091087|144510312|SUPERIORITY||LS mean Difference|-16.01|STANDARD_ERROR_OF_MEAN|22.44||0.2392|TWO_SIDED|90.0|-53.54|21.52||1-sided|Normal approximation test|||Week 4||21.52|-53.54|0.2392
72491043|NCT04091087|144510312|SUPERIORITY||LS mean Difference|-13.01|STANDARD_ERROR_OF_MEAN|19.65||0.2553|TWO_SIDED|90.0|-45.87|19.85||1-sided|Normal approximation test|||Week 5||19.85|-45.87|0.2553
72491044|NCT04091087|144510312|SUPERIORITY||LS mean Difference|-53.01|STANDARD_ERROR_OF_MEAN|30.05||0.0416|TWO_SIDED|90.0|-103.26|-2.75||1-sided|Normal approximation test|||Week 6||-2.75|-103.26|0.0416
72369284|NCT00611026|144248566|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.0||0.0701|TWO_SIDED|95.0|-0.1|0.0|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment with baseline value as a covariate.|Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.|Treatment difference fesoterodine vs placebo at Week 1.||0.0|-0.1|0.0701
72369285|NCT00611026|144248566|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.0||0.4823|TWO_SIDED|95.0|-0.1|0.0|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment with baseline value as a covariate.|Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.|Treatment difference Tolterodine ER vs placebo at Week 1.||0.0|-0.1|0.4823
72369286|NCT00611026|144248566|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.0||0.1702|TWO_SIDED|95.0|-0.1|0.0|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment with baseline value as a covariate.|Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.|Treatment difference Tolterodine ER vs Fesoterodine at Week 1.||0.0|-0.1|0.1702
72369287|NCT00611026|144248566|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.0|<|0.0001|TWO_SIDED|95.0|-0.3|-0.1|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment with baseline value as a covariate.|Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.|Treatment difference fesoterodine vs placebo at Week 4.||-0.1|-0.3|<0.0001
72369288|NCT00611026|144248566|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.0||0.0059|TWO_SIDED|95.0|-0.2|0.0|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment with baseline value as a covariate.|Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.|Treatment difference Tolterodine ER vs placebo at Week 4.||-0.0|-0.2|0.0059
72369289|NCT00611026|144248566|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.0||0.0014|TWO_SIDED|95.0|-0.2|0.0|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment with baseline value as a covariate.|Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.|Treatment difference Tolterodine ER vs Fesoterodine at Week 4.||-0.0|-0.2|0.0014
72369290|NCT00611026|144248566|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.0|<|0.0001|TWO_SIDED|95.0|-0.3|-0.1|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment with baseline value as a covariate.|Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.|Treatment difference fesoterodine vs placebo at Week 12.||-0.1|-0.3|<0.0001
72491045|NCT04152161|144510319|SUPERIORITY||Vaccine Efficacy|-0.049|||||TWO_SIDED|95.0|-0.431|0.23|||||Vaccine Efficacy (VE) = 1 - Hazard Ratio, with 95%CI equal to (VE lower limit, VE upper limit) = (1 - Hazard Ratio upper limit, 1 - Hazard Ratio lower limit)|||0.230|-0.431|
72491046|NCT04152161|144510319|SUPERIORITY||Hazard Ratio (HR)|1.049||||0.6193|TWO_SIDED|95.0|0.77|1.431|||Log Rank|The 1-sided p-value from the log-rank test was stratified by sex and age group.|Hazard ratio was calculated using a stratified Cox proportional hazards model, with sex and age group (10-11 years, 12-14 years, and \>14 years) as stratification variables.|||1.431|0.770|0.6193
72491047|NCT04152161|144510320|SUPERIORITY||Vaccine Efficacy|-0.009|||||TWO_SIDED|95.0|-0.395|0.27|||||Vaccine Efficacy (VE) = 1 - Hazard Ratio, with 95%CI equal to (VE lower limit, VE upper limit) = (1 - Hazard Ratio upper limit, 1 - Hazard Ratio lower limit)|||0.270|-0.395|
72491048|NCT04152161|144510320|SUPERIORITY||Hazard Ratio (HR)|1.009||||0.5224|TWO_SIDED|95.0|0.73|1.395|||Log Rank|The 1-sided p-value from the log-rank test was stratified by sex and age group.|Hazard ratio was calculated using a stratified Cox proportional hazards model, with sex and age group (10-11 years, 12-14 years, and \>14 years) as stratification variables.|||1.395|0.730|0.5224
72491049|NCT04152161|144510321|SUPERIORITY||Vaccine Efficacy|-0.049|||||TWO_SIDED|95.0|-0.431|0.23|||||Vaccine Efficacy (VE) = 1 - Hazard Ratio, with 95%CI equal to (VE lower limit, VE upper limit) = (1 - Hazard Ratio upper limit, 1 - Hazard Ratio lower limit)|||0.230|-0.431|
72491050|NCT04152161|144510321|SUPERIORITY||Hazard Ratio (HR)|1.049||||0.6193|TWO_SIDED|95.0|0.77|1.431|||Log Rank|The 1-sided p-value from the log-rank test was stratified by sex and age group.|Calculated using a stratified Cox proportional hazards model, with sex and age group (10-11 years, 12-14 years, and \>14 years) as stratification variables.|||1.431|0.770|0.6193
72491051|NCT03703102|144510331|SUPERIORITY||||||<|0.001|||||||ANCOVA|||||||< 0.001
72369112|NCT00478023|144248220|SUPERIORITY_OR_OTHER_LEGACY||Least square mean difference|44.0|||<|0.0001||95.0|28.6|59.5||Adjusted. The Hochberg procedure used for multiplicity comparisons.|ANCOVA|ANCOVA with treatment and centre as fixed effects and baseline pain as covariates.|Only pain intensity assessments collected prior to the first dose of any additional analgesic medication considered. Afterwards LOCF used.|The null hypothesis is that all CG5503 IR dose groups are equal to the placebo group based on the mean sum of pain intensity difference at 48 hours (SPID48). The alternative hypothesis is that at least one CG5503 IR dose group is different from the placebo group based on the mean SPID48.||59.5|28.6|<0.0001
72491052|NCT03703102|144510331|SUPERIORITY||||||<|0.001|||||||ANCOVA|||||||< 0.001
72491053|NCT03703102|144510331|SUPERIORITY||||||<|0.001|||||||ANCOVA|||||||< 0.001
72491054|NCT03703102|144510331|SUPERIORITY||||||<|0.001|||||||ANCOVA|||||||< 0.001
72491055|NCT05074251|144510377|SUPERIORITY||Risk Ratio (RR)|1.41|||<|0.05|TWO_SIDED|95.0|1.14|1.75|||Regression, Logistic|||||1.75|1.14|<0.05
72491056|NCT02915523|144510381|OTHER||Hazard Ratio (HR)|0.899|||||TWO_SIDED|95.0|0.581|1.393|||||Stratified HR estimated from a stratified univeriate Cox proportional hazards model. Avelumab + placebo was the reference treatment group.|||1.393|0.581|
72491057|NCT00930761|144510402|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.22||||0.06||95.0|0.99|1.51|||Chi-squared|||Null hypothesis: Music therapy does not increase the rate of maternal breastfeeding. Sample size: considering 75% as the expected rate at the time of the infant hospital discharge and an absolute difference of 30% between groups, 95% confidence level (5% alpha error) and 80% power (20% beta error), 94 subjects would need to be enrolled (47 in each study arm). Expecting a 7.5% loss after randomization, 101 was the total number of subjects considered necessary to conduct the study.||1.51|0.99|0.06
72491058|NCT00930761|144510403|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.21||||0.13||95.0|0.73|5.66|||Chi-squared|||||5.66|0.73|0.13
72491059|NCT00930761|144510404|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.26||||0.03||95.0|1.01|1.57|||Chi-squared|||Null hypothesis: Music therapy does not increase the rate of maternal breastfeeding. Sample size: considering 75% as the expected rate at the time of the first follow-up visit and an absolute difference of 30% between groups, 95% confidence level (5% alpha error) and 80% power (20% beta error), 94 subjects would need to be enrolled (47 in each study arm). Expecting a 7.5% loss after randomization, 101 was the total number of subjects considered necessary to conduct the study.||1.57|1.01|0.03
72491060|NCT00930761|144510405|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.28||||0.09||95.0|0.95|1.71|||Chi-squared|||||1.71|0.95|0.09
72491061|NCT04677959|144510417|OTHER||Odds Ratio (OR)|1.35|||||TWO_SIDED|95.0||||||||The 95% credible intervals of the odds ratio from the posterior distributions were calculated and presented.||||
72491062|NCT00763815|144510436|SUPERIORITY_OR_OTHER||Least Squares (LS) Mean Difference|-0.56|STANDARD_ERROR_OF_MEAN|0.088|<|0.0001|TWO_SIDED|95.0|-0.731|-0.386||Statistical testing: 2-sided at significance level=0.05. Analysis of co-variance (ANCOVA) included treatment arms; randomization strata of screening HbA1c (\<8.0, \>=8.0%), metformin use (yes, no); country as fixed effects; baseline HbA1c as covariate.|ANCOVA|||To detect a difference of 0.5% (or 0.4%) in change from baseline to Week 24 in HbA1c between lixisenatide and placebo, 300 patients in lixisenatide arm and 150 patients in placebo arm would provide a power of 96% (or 86%) assuming common standard deviation of 1.3% with a 2-sided test at 5% significance level.||-0.386|-0.731|<0.0001
72491063|NCT01970995|144510446|SUPERIORITY_OR_OTHER_LEGACY||Geometric LS Mean Ratio|13.49|||<|0.001|TWO_SIDED|95.0|10.96|16.6||The primary endpoints were tested using a multiple testing procedure to preserve the overall alpha level by simultaneously testing the endpoints using a closed procedure with each test performed at an alpha level of 2.5% one sided.|ANCOVA|ANCOVA model on MHBMA levels with product, sex, cigarette consumption, and baseline value as covariates.|Geometric LS mean ratio mTHS 2.2:mCC|"The hypothesis to be tested is that the geometric mean level on Day 5 of the biomarker of exposure for mTHS 2.2 is lower relative to mCC.~Analysis of the biomarker of exposure (BoExp) was conducted on the natural log scale in order to test the following hypothesis (one sided test with 2.5% type I error probability):~* Null hypothesis (H0): m1≥m2~* Alternative hypothesis (H1): m1\<m2 Where m1 and m2 are the geometric means of the BoExp levels on Day 5 for mTHS 2.2 and mCC respectively."||16.60|10.96|<.001
72491064|NCT01970995|144510447|SUPERIORITY_OR_OTHER_LEGACY||Geometric LS Mean Ratio|50.67|||<|0.001|TWO_SIDED|95.0|44.88|57.2||The primary endpoints were tested using a multiple testing procedure to preserve the overall alpha level by simultaneously testing the endpoints using a closed procedure with each test performed at an alpha level of 2.5% one sided.|ANCOVA|ANCOVA model on 3-HPMA levels with product, sex, cigarette consumption, and baseline value as covariates.|Geometric LS mean ratio mTHS 2.2:mCC|"The hypothesis to be tested is that the geometric mean level on Day 5 of the biomarker of exposure for mTHS 2.2 is lower relative to mCC.~Analysis of the BoExp was conducted on the natural log scale in order to test the following hypothesis (one sided test with 2.5% type I error probability):~* Null hypothesis (H0): m1≥m2~* Alternative hypothesis (H1): m1\<m2 Where m1 and m2 are the geometric means of the BoExp levels on Day 5 for mTHS 2.2 and mCC respectively."||57.20|44.88|<.001
72517148|NCT02528253|144564403|SUPERIORITY||LS Mean Difference|-0.46|STANDARD_ERROR_OF_MEAN|0.18||0.0133|TWO_SIDED|95.0|-0.82|-0.09|||ANCOVA|||Change at Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with normal work, and baseline average LBPI as covariates, and study site as a random effect.||-0.09|-0.82|0.0133
72517149|NCT02528253|144564403|SUPERIORITY||LS Mean Difference|-0.25|STANDARD_ERROR_OF_MEAN|0.2||0.2157|TWO_SIDED|95.0|-0.65|0.15|||ANCOVA|||Change at Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with normal work, and baseline average LBPI as covariates, and study site as a random effect.||0.15|-0.65|0.2157
72517150|NCT02528253|144564403|SUPERIORITY||LS Mean Difference|-0.36|STANDARD_ERROR_OF_MEAN|0.2||0.0781|TWO_SIDED|95.0|-0.76|0.04|||ANCOVA|||Change at Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with normal work, and baseline average LBPI as covariates, and study site as a random effect.||0.04|-0.76|0.0781
72624649|NCT01346592|144778956|SUPERIORITY_OR_OTHER||Group difference (H1N1 strain)|10.4|||||TWO_SIDED|95.0|6.1|14.7||||||superiority was concluded if the lower limit of the confidence interval of day 50 vaccine group difference,for at least 2 homologous strains, was \>10%||14.7|6.1|
72624650|NCT01346592|144778956|SUPERIORITY_OR_OTHER||Group difference (H3N2 strain)|2.5|||||TWO_SIDED|95.0|-0.12|5.1||||||superiority was concluded if the lower limit of the confidence interval of day 50 vaccine group difference,for at least 2 homologous strains, was \>10%||5.1|-0.12|
72624651|NCT01346592|144778956|SUPERIORITY_OR_OTHER||Group difference (B strain)|12.8|||||TWO_SIDED|95.0|8.9|16.7||||||superiority was concluded if the lower limit of the confidence interval of day 50 vaccine group difference,for at least 2 homologous strains, was \>10%||16.7|8.9|
72624652|NCT01346592|144778956|SUPERIORITY_OR_OTHER||Group difference (H1N1 strain)|17.7|||||TWO_SIDED|95.0|12.9|22.6||||||superiority was concluded if the lower limit of the confidence interval of day 50 vaccine group difference,for at least 2 homologous strains, was \>10%||22.6|12.9|
72624653|NCT01346592|144778956|SUPERIORITY_OR_OTHER||Group difference (H3N2 strain)|5.6|||||TWO_SIDED|95.0|2.5|8.7||||||superiority was concluded if the lower limit of the confidence interval of day 50 vaccine group difference,for at least 2 homologous strains, was \>10%||8.7|2.5|
72624654|NCT01346592|144778956|SUPERIORITY_OR_OTHER||Group difference (B strain)|18.8|||||TWO_SIDED|95.0|14.4|23.1||||||superiority was concluded if the lower limit of the confidence interval of day 50 vaccine group difference,for at least 2 homologous strains, was \>10%||23.1|14.4|
72624655|NCT01346592|144778957|SUPERIORITY_OR_OTHER||GMT Ratio (H1N1 strain)|2.38|||||TWO_SIDED|95.0|2.07|2.75||||||superiority was concluded if the lower limit of the confidence interval of the day 50 vaccine group GMT ratios for at least 2 homologous strains was \>1.5||2.75|2.07|
72624656|NCT01346592|144778957|SUPERIORITY_OR_OTHER||GMT Ratio (H3N2 strain)|1.88|||||TWO_SIDED|95.0|1.72|2.06||||||superiority was concluded if the lower limit of the confidence interval of the day 50 vaccine group GMT ratios for at least 2 homologous strains was \>1.5||2.06|1.72|
72624657|NCT01346592|144778957|SUPERIORITY_OR_OTHER||GMT Ratio (B strain)|2.93|||||TWO_SIDED|95.0|2.6|3.3||||||superiority was concluded if the lower limit of the confidence interval of the day 50 vaccine group GMT ratios for at least 2 homologous strains was \>1.5||3.3|2.6|
72404880|NCT00782210|144317137|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.263|STANDARD_ERROR_OF_MEAN|0.039|<|0.0001||95.0|0.187|0.339|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.339|0.187|<0.0001
72517151|NCT02528253|144564403|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.21||0.3527|TWO_SIDED|95.0|-0.62|0.22|||ANCOVA|||Change at Week 32: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with normal work, and baseline average LBPI as covariates, and study site as a random effect.||0.22|-0.62|0.3527
72404881|NCT00782210|144317137|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3|STANDARD_ERROR_OF_MEAN|0.039|<|0.0001||95.0|0.225|0.376|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.376|0.225|<0.0001
72517152|NCT02528253|144564403|SUPERIORITY||LS Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.22||0.2994|TWO_SIDED|95.0|-0.65|0.2|||ANCOVA|||Change at Week 32: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with normal work, and baseline average LBPI as covariates, and study site as a random effect.||0.20|-0.65|0.2994
72517153|NCT02528253|144564403|SUPERIORITY||LS Mean Difference|-0.21|STANDARD_ERROR_OF_MEAN|0.22||0.3326|TWO_SIDED|95.0|-0.63|0.21|||ANCOVA|||Change at Week 40: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with normal work, and baseline average LBPI as covariates, and study site as a random effect.||0.21|-0.63|0.3326
72624658|NCT01346592|144778957|SUPERIORITY_OR_OTHER||GMT Ratio (H1N1 strain)|3.21|||||TWO_SIDED|95.0|2.79|3.71||||||superiority was concluded if the lower limit of the confidence interval of the day 50 vaccine group GMT ratios for at least 2 homologous strains was \>1.5||3.71|2.79|
72624659|NCT01346592|144778957|SUPERIORITY_OR_OTHER||GMT Ratio (H3N2 strain)|2.4|||||TWO_SIDED|95.0|2.19|2.62||||||superiority was concluded if the lower limit of the confidence interval of the day 50 vaccine group GMT ratios for at least 2 homologous strains was \>1.5||2.62|2.19|
72624660|NCT01346592|144778957|SUPERIORITY_OR_OTHER||GMT Ratio (B strain)|3.08|||||TWO_SIDED|95.0|2.73|3.47||||||superiority was concluded if the lower limit of the confidence interval of the day 50 vaccine group GMT ratios for at least 2 homologous strains was \>1.5||3.47|2.73|
72624661|NCT01346592|144778958|SUPERIORITY_OR_OTHER||Group difference (H1N1 strain)|9.3|||||TWO_SIDED|95.0|6.3|12.4||||||superiority was concluded if the lower limit of the confidence interval of day 50 vaccine group difference,for at least 2 homologous strains, was \>10%||12.4|6.3|
72624662|NCT01346592|144778958|SUPERIORITY_OR_OTHER||Group difference (H3N2 strain)|3.9|||||TWO_SIDED|95.0|1.8|5.9||||||superiority was concluded if the lower limit of the confidence interval of day 50 vaccine group difference,for at least 2 homologous strains, was \>10%||5.9|1.8|
72624663|NCT01346592|144778958|SUPERIORITY_OR_OTHER||Group difference (B strain)|10.7|||||TWO_SIDED|95.0|8.1|13.3||||||superiority was concluded if the lower limit of the confidence interval of day 50 vaccine group difference,for at least 2 homologous strains, was \>10%||13.3|8.1|
72624664|NCT01346592|144778958|SUPERIORITY_OR_OTHER||Group difference (H1N1 strain)|14.4|||||TWO_SIDED|95.0|11.1|17.7||||||superiority was concluded if the lower limit of the confidence interval of day 50 vaccine group difference,for at least 2 homologous strains, was \>10%||17.7|11.1|
72624665|NCT01346592|144778958|SUPERIORITY_OR_OTHER||Group difference (H3N2 strain)|6.8|||||TWO_SIDED|95.0|4.5|9.1||||||superiority was concluded if the lower bound of 95% CI of day 50 vaccine group difference,for at least 2 homologous strains, was \>10%||9.1|4.5|
72624666|NCT01346592|144778958|SUPERIORITY_OR_OTHER||Group difference (B strain)|10.9|||||TWO_SIDED|95.0|8.3|13.4||||||superiority was concluded if the lower limit of the confidence interval of day 50 vaccine group difference,for at least 2 homologous strains, was \>10%||13.4|8.3|
72624667|NCT01346592|144778963|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT Ratio (H1N1 strain)|2.68|||||TWO_SIDED|95.0|2.3|3.12||||||No risk subjects.||3.12|2.3|
72404882|NCT00782210|144317138|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.264|STANDARD_ERROR_OF_MEAN|0.039|<|0.0001||95.0|0.188|0.341|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.341|0.188|<0.0001
72577150|NCT00264550|144680885|SUPERIORITY_OR_OTHER||||||<|0.001||||||The positive test is defined if the comparison between combined golimumab+MTX and Group 1 is significant at the 0.05, and at least one of the pair-wise comparisons is also significant at the 0.05.|Chi-squared|||Null hypothesis: No difference in ACR 20 response at Wk 14 comparing Groups I vs III and Groups I vs IV at 0.05 level of significance. Assuming greater than 90 % power, ACR 20 response for Group I, Group III and Group IV (120, 80, and 80 participants, respectively) as 35 % for Group I and 55 % for Groups III and IV.||||<0.001
72624668|NCT01346592|144778963|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT Ratio (H3N2 strain)|1.87|||||TWO_SIDED|95.0|1.7|2.05||||||No risk subjects.||2.05|1.7|
72624669|NCT01346592|144778963|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (B strain)|3.04|||||TWO_SIDED|95.0|2.68|3.44||||||No risk subjects.||3.44|2.68|
72624670|NCT01346592|144778963|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (H1N1 strain)|2.21|||||TWO_SIDED|95.0|1.11|4.42||||||At risk subjects.||4.42|1.11|
72624671|NCT01346592|144778963|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (H3N2 strain)|2.45|||||TWO_SIDED|95.0|1.61|3.72||||||At risk subjects.||3.72|1.61|
72624672|NCT01346592|144778963|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (B strain)|3.46|||||TWO_SIDED|95.0|1.88|6.34||||||At risk subjects||6.34|1.88|
72624673|NCT01346592|144778963|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratios (H1N1 strain)|3.52|||||TWO_SIDED|95.0|3.03|4.1||||||No risk subjects.||4.1|3.03|
72624674|NCT01346592|144778963|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (H3N2 strain)|2.36|||||TWO_SIDED|95.0|2.15|2.59||||||No risk subjects.||2.59|2.15|
72404883|NCT00782210|144317138|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.292|STANDARD_ERROR_OF_MEAN|0.039|<|0.0001||95.0|0.216|0.368|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.368|0.216|<0.0001
72624675|NCT01346592|144778963|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (B strain)|3.14|||||TWO_SIDED|95.0|2.78|3.56||||||No risk subjects.||3.56|2.78|
72491065|NCT01970995|144510448|SUPERIORITY_OR_OTHER_LEGACY||Geometric LS Mean Ratio|10.97|||<|0.001|TWO_SIDED|95.0|9.26|12.99||The primary endpoints were tested using a multiple testing procedure to preserve the overall alpha level by simultaneously testing the endpoints using a closed procedure with each test performed at an alpha level of 2.5% one sided.|ANCOVA|ANCOVA model on S-PMA levels with product, sex, cigarette consumption, and baseline value as covariates.|Geometric LS mean ratio mTHS 2.2:mCC|"The hypothesis to be tested is that the geometric mean level on Day 5 of the biomarker of exposure for mTHS 2.2 is lower relative to mCC.~Analysis of the BoExp was conducted on the natural log scale in order to test the following hypothesis (one sided test with 2.5% type I error probability):~* Null hypothesis (H0): m1≥m2~* Alternative hypothesis (H1): m1\<m2 Where m1 and m2 are the geometric means of the BoExp levels on Day 5 for mTHS 2.2 and mCC respectively."||12.99|9.26|<.001
72517154|NCT02528253|144564403|SUPERIORITY||LS Mean Difference|-0.23|STANDARD_ERROR_OF_MEAN|0.21||0.2822|TWO_SIDED|95.0|-0.65|0.19|||ANCOVA|||Change at Week 40: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with normal work, and baseline average LBPI as covariates, and study site as a random effect.||0.19|-0.65|0.2822
72491066|NCT01970995|144510449|SUPERIORITY_OR_OTHER_LEGACY||Geometric LS Mean Ratio|44.94|||<|0.001|TWO_SIDED|95.0|42.11|47.97||The primary endpoints were tested using a multiple testing procedure to preserve the overall alpha level by simultaneously testing the endpoints using a closed procedure with each test performed at an alpha level of 2.5% one sided.|ANCOVA|ANCOVA model on COHb levels with product, sex, cigarette consumption, and baseline value as covariates.|Geometric LS mean ratio mTHS 2.2:mCC|"The hypothesis to be tested is that the geometric mean level on Day 5 of the biomarker of exposure for mTHS 2.2 is lower relative to mCC.~Analysis of the BoExp was conducted on the natural log scale in order to test the following hypothesis (one sided test with 2.5% type I error probability):~* Null hypothesis (H0): m1≥m2~* Alternative hypothesis (H1): m1\<m2 Where m1 and m2 are the geometric means of the BoExp levels on Day 5 for mTHS 2.2 and mCC respectively."||47.97|42.11|<.001
72517155|NCT02528253|144564403|SUPERIORITY||LS Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.22||0.4932|TWO_SIDED|95.0|-0.57|0.28|||ANCOVA|||Change at Week 48: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with normal work, and baseline average LBPI as covariates, and study site as a random effect.||0.28|-0.57|0.4932
72517156|NCT02528253|144564403|SUPERIORITY||LS Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.22||0.4571|TWO_SIDED|95.0|-0.58|0.26|||ANCOVA|||Change at Week 48: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with normal work, and baseline average LBPI as covariates, and study site as a random effect.||0.26|-0.58|0.4571
72491067|NCT01970995|144510450|SUPERIORITY_OR_OTHER_LEGACY||Geometric LS Mean Ratio|23.25|||<|0.001|TWO_SIDED|95.0|17.38|31.11||The primary endpoints were tested using a multiple testing procedure to preserve the overall alpha level by simultaneously testing the endpoints using a closed procedure with each test performed at an alpha level of 2.5% one sided.|ANCOVA|ANCOVA model on Total NNAL levels with product, sex, cigarette consumption, and baseline value as covariates|Geometric LS mean ratio mTHS 2.2:mCC|"The hypothesis to be tested is that the geometric mean level on Day 90 of the biomarker of exposure for mTHS 2.2 is lower relative to mCC.~Analysis of the BoExp was conducted on the natural log scale in order to test the following hypothesis (one sided test with 2.5% type I error probability):~* Null hypothesis (H0): m1≥m2~* Alternative hypothesis (H1): m1\<m2 Where m1 and m2 are the geometric means of the BoExp levels on Day 90 for mTHS 2.2 and mCC respectively."||31.11|17.38|<.001
72517157|NCT02528253|144564403|SUPERIORITY||LS Mean Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.22||0.5586|TWO_SIDED|95.0|-0.56|0.3|||ANCOVA|||Change at Week 56: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with normal work, and baseline average LBPI as covariates, and study site as a random effect.||0.30|-0.56|0.5586
72517158|NCT02528253|144564403|SUPERIORITY||LS Mean Difference|-0.24|STANDARD_ERROR_OF_MEAN|0.22||0.2664|TWO_SIDED|95.0|-0.67|0.19|||ANCOVA|||Change at Week 56: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with normal work, and baseline average LBPI as covariates, and study site as a random effect.||0.19|-0.67|0.2664
72517159|NCT02528253|144564405|SUPERIORITY||Odds Ratio (OR)|2.14||||0.001|TWO_SIDED|95.0|1.36|3.36|||Regression, Logistic|||Week 2: OR and 95% CI estimated from logistic regression model. Logistic regression model included treatment as fixed effect and baseline average LBPI, baseline PGA, and baseline RMDQ as covariates.||3.36|1.36|0.0010
72517160|NCT02528253|144564405|SUPERIORITY||Odds Ratio (OR)|2.68|||<|0.0001|TWO_SIDED|95.0|1.73|4.16|||Regression, Logistic|||Week 2: OR and 95% CI estimated from logistic regression model. Logistic regression model included treatment as fixed effect and baseline average LBPI, baseline PGA, and baseline RMDQ as covariates.||4.16|1.73|<.0001
72517161|NCT02528253|144564405|SUPERIORITY||Odds Ratio (OR)|1.62||||0.03|TWO_SIDED|95.0|1.05|2.51|||Regression, Logistic|||Week 2: OR and 95% CI estimated from logistic regression model. Logistic regression model included treatment as fixed effect and baseline average LBPI, baseline PGA, and baseline RMDQ as covariates.||2.51|1.05|0.0300
72517162|NCT02528253|144564405|SUPERIORITY||Odds Ratio (OR)|2.03|||<|0.0001|TWO_SIDED|95.0|1.44|2.86|||Regression, Logistic|||Week 4: OR and 95% CI estimated from logistic regression model. Logistic regression model included treatment as fixed effect and baseline average LBPI, baseline PGA, and baseline RMDQ as covariates.||2.86|1.44|<.0001
72624676|NCT01346592|144778963|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (H1N1 strain)|2.7|||||TWO_SIDED|95.0|1.28|5.68||||||At risk subjects.||5.68|1.28|
72624677|NCT01346592|144778963|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (H3N2 strain)|3.25|||||TWO_SIDED|95.0|2.09|5.06||||||At risk subjects.||5.06|2.09|
72569112|NCT01055132|144669344|NON_INFERIORITY_OR_EQUIVALENCE|Based on historical data, a minimum of 42 subjects is needed to achieve a minimum of 80% power with 0.05 type I error.|Least-square mean difference|-0.015|STANDARD_ERROR_OF_MEAN|0.0062|||TWO_SIDED|95.0|-0.027|-0.003|||linear mixed model|Sequence of wear,lens period and lens were included in the model as fixed effects; site, patient, period\*patient were included as random effects.|Comparison between study lenses was carried out using 2-sided 95% confidence interval of the least-square mean difference (test minus control). The non-inferiority was concluded if the upper limit of the confidence limit is below 0.05 LogMAR.|Ho:The test lens is non-inferior to the active comparator lens for Binocular visual performance on logMAR scale at 1-week follow-up. A non-inferiority margin of 0.05 logMAR was used.||-0.003|-0.027|
72569113|NCT01055132|144669345|NON_INFERIORITY_OR_EQUIVALENCE|Based on historical data, a minimum of 42 subjects is needed to achieve a minimum of 80% power with 0.05 type I error.|Least-square mean difference|11.9|STANDARD_ERROR_OF_MEAN|3.93|||TWO_SIDED|95.0|4.05|19.79|||linear mixed model|Sequence of lens wear, lens period and lens type were included in the model as fixed effects; and Site and patient as random effects.|Comparison between study lenses was carried out using 2-sided 95% confidence interval of the least-square mean difference (test minus control). The non-inferiority was concluded if the lower limit of the confidence interval is higher than -5.|Ho:The test lens is non-inferior to the active comparator lens for comfort at 1-week follow-up. A non-inferiority margin of -5 units was used.||19.79|4.05|
72569114|NCT01055132|144669346|NON_INFERIORITY_OR_EQUIVALENCE|Based on historical data, a minimum of 42 subjects is needed to achieve a minimum of 80% power with 0.05 type I error.|least-square mean difference|7.7|STANDARD_ERROR_OF_MEAN|3.55|||TWO_SIDED|95.0|0.58|14.8|||linear mixed model|Sequence of lens wear, lens period and lens type were included in the model as fixed effects; and site and patient as random effects.|Comparison between study lenses was carried out using 2-sided 95% confidence interval of the least-square mean difference (test minus control). The non-inferiority was concluded if the lower limit of the confidence interval is higher than -5.|Ho:The test lens is non-inferior to the active comparator lens for overall quality of vision at 1-week follow-up. A non-inferiority margin of -5 units was used.||14.80|0.58|
72517163|NCT02528253|144564405|SUPERIORITY||Odds Ratio (OR)|2.37|||<|0.0001|TWO_SIDED|95.0|1.69|3.32|||Regression, Logistic|||Week 4: OR and 95% CI estimated from logistic regression model. Logistic regression model included treatment as fixed effect and baseline average LBPI, baseline PGA, and baseline RMDQ as covariates.||3.32|1.69|<.0001
72517164|NCT02528253|144564405|SUPERIORITY||Odds Ratio (OR)|1.44||||0.029|TWO_SIDED|95.0|1.04|1.99|||Regression, Logistic|||Week 4: OR and 95% CI estimated from logistic regression model. Logistic regression model included treatment as fixed effect and baseline average LBPI, baseline PGA, and baseline RMDQ as covariates.||1.99|1.04|0.0290
72569115|NCT00063635|144669387|SUPERIORITY_OR_OTHER|||||||0.26||95.0||||Since two primary comparisons are planned, a P-value of 0.025 will be considered significant, applying a Bonferroni correction for multiple comparisons.|Mantel Haenszel|||||||0.26
72569116|NCT00063635|144669387|SUPERIORITY_OR_OTHER|||||||0.83||95.0||||Since two primary comparisons are planned, a P-value of 0.025 will be considered significant, applying a Bonferroni correction for multiple comparisons.|Mantel Haenszel|||||||0.83
72569117|NCT00063635|144669388|SUPERIORITY_OR_OTHER|||||||0.32||95.0|||||ANCOVA|||||||0.32
72569118|NCT00063635|144669388|SUPERIORITY_OR_OTHER|||||||0.29||95.0|||||ANCOVA|||||||0.29
72517165|NCT02528253|144564405|SUPERIORITY||Odds Ratio (OR)|1.8||||0.0003|TWO_SIDED|95.0|1.31|2.47|||Regression, Logistic|||Week 8: OR and 95% CI estimated from logistic regression model. Logistic regression model included treatment as fixed effect and baseline average LBPI, baseline PGA, and baseline RMDQ as covariates.||2.47|1.31|0.0003
72517166|NCT02528253|144564405|SUPERIORITY||Odds Ratio (OR)|2.21|||<|0.0001|TWO_SIDED|95.0|1.62|3.03|||Regression, Logistic|||Week 8: OR and 95% CI estimated from logistic regression model. Logistic regression model included treatment as fixed effect and baseline average LBPI, baseline PGA, and baseline RMDQ as covariates.||3.03|1.62|<.0001
72569119|NCT00063635|144669389|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||ANCOVA|||||||0.02
72569120|NCT00063635|144669389|SUPERIORITY_OR_OTHER|||||||0.25||95.0|||||ANCOVA|||||||0.25
72569121|NCT00063635|144669390|SUPERIORITY_OR_OTHER|||||||0.71||95.0|||||Chi-squared|||||||0.71
72569122|NCT00063635|144669390|SUPERIORITY_OR_OTHER|||||||0.72||95.0|||||Chi-squared|||||||0.72
72569123|NCT00063635|144669391|SUPERIORITY_OR_OTHER|||||||0.18||95.0|||||Chi-squared|||||||0.18
72569124|NCT00063635|144669391|SUPERIORITY_OR_OTHER|||||||0.25||95.0|||||Chi-squared|||||||0.25
72569125|NCT00063635|144669392|SUPERIORITY_OR_OTHER|||||||0.89||95.0|||||Chi-squared|||||||0.89
72569126|NCT00063635|144669392|SUPERIORITY_OR_OTHER|||||||0.73||95.0|||||Chi-squared|||||||0.73
72569127|NCT00063635|144669393|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||Chi-squared|||||||0.02
72569128|NCT00063635|144669393|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||Chi-squared|||||||0.02
72569129|NCT00063635|144669394|SUPERIORITY_OR_OTHER|||||||0.77||95.0|||||ANCOVA|||||||0.77
72569130|NCT00063635|144669394|SUPERIORITY_OR_OTHER|||||||0.25||95.0|||||ANCOVA|||||||0.25
72569131|NCT00063635|144669395|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||||||<0.001
72569132|NCT00063635|144669395|SUPERIORITY_OR_OTHER|||||||0.44||95.0|||||ANCOVA|||||||0.44
72569133|NCT00063635|144669396|SUPERIORITY_OR_OTHER|||||||0.08||95.0|||||ANCOVA|||||||0.08
72569134|NCT00063635|144669396|SUPERIORITY_OR_OTHER|||||||0.63||95.0|||||ANCOVA|||||||0.63
72569135|NCT00063635|144669397|SUPERIORITY_OR_OTHER|||||||0.15||95.0|||||ANCOVA|||||||0.15
72569136|NCT00063635|144669397|SUPERIORITY_OR_OTHER|||||||0.96||95.0|||||ANCOVA|||||||0.96
72577151|NCT00264550|144680885|SUPERIORITY_OR_OTHER|||||||0.001|||||||Chi-squared|||Null hypothesis: No difference in ACR 20 response at Wk 14 comparing Groups I vs III and Groups I vs IV at 0.05 level of significance. Samples of sizes 120, 80, 80 patients in Group I, III, and IV provide \>90% power assuming 35% response in Group I and 55% ACR 20 response in golimumab groups(III \& IV).||||0.001
72577152|NCT00264550|144680885|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Chi-squared|||Null hypothesis: No difference in ACR 20 response at Wk 14 comparing Groups I vs III and Groups I vs IV at 0.05 level of significance. Samples of sizes 120, 80, 80 patients in Group I, III, and IV provide \>90% power assuming 35% response in Group I and 55% ACR 20 response in golimumab groups(III \& IV).||||<0.001
72404884|NCT00782210|144317139|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.251|STANDARD_ERROR_OF_MEAN|0.039|<|0.0001||95.0|0.174|0.328|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.328|0.174|<0.0001
72491068|NCT05284760|144510458|EQUIVALENCE|The two treatments were deemed equivalent if the 90% CIs for the GMRs for all of the parameters were each within 80.00% and 125.00%.|Geometric Mean Ratio (GMR)|97.28|||||TWO_SIDED|90.0|87.66|107.96||||||||107.96|87.66|
72491069|NCT05284760|144510458|EQUIVALENCE|The two treatments were deemed equivalent if the 90% CIs for the GMRs for all of the parameters were each within 80.00% and 125.00%.|GMR|81.04|||||TWO_SIDED|90.0|73.06|89.89||||||||89.89|73.06|
72491070|NCT05284760|144510458|OTHER||GMR|37.48|||||TWO_SIDED|90.0|31.1|45.17||||||||45.17|31.10|
72491071|NCT05284760|144510458|OTHER||GMR|89.45|||||TWO_SIDED|90.0|74.24|107.79||||||||107.79|74.24|
72491072|NCT05284760|144510459|EQUIVALENCE|The two treatments were deemed equivalent if the 90% CIs for the GMRs for all of the parameters were each within 80.00% and 125.00%.|GMR|97.52|||||TWO_SIDED|90.0|92.17|103.17||||||||103.17|92.17|
72491073|NCT05284760|144510459|EQUIVALENCE|The two treatments were deemed equivalent if the 90% CIs for the GMRs for all of the parameters were each within 80.00% and 125.00%.|GMR|86.88|||||TWO_SIDED|90.0|82.14|91.89||||||||91.89|82.14|
72491074|NCT05284760|144510459|OTHER||GMR|87.63|||||TWO_SIDED|90.0|75.92|101.15||||||||101.15|75.92|
72491075|NCT05284760|144510459|OTHER||GMR|95.49|||||TWO_SIDED|90.0|82.73|110.22||||||||110.22|82.73|
72491076|NCT05284760|144510460|EQUIVALENCE|The two treatments were deemed equivalent if the 90% CIs for the GMRs for all of the parameters were each within 80.00% and 125.00%.|GMR|99.25|||||TWO_SIDED|90.0|92.84|106.1||||||||106.10|92.84|
72491077|NCT05284760|144510460|EQUIVALENCE|The two treatments were deemed equivalent if the 90% CIs for the GMRs for all of the parameters were each within 80.00% and 125.00%.|GMR|86.98|||||TWO_SIDED|90.0|81.33|93.03||||||||93.03|81.33|
72491078|NCT05284760|144510460|OTHER||GMR|89.28|||||TWO_SIDED|90.0|78.92|100.99||||||||100.99|78.92|
72491079|NCT05284760|144510460|OTHER||GMR|92.77|||||TWO_SIDED|90.0|81.77|105.25||||||||105.25|81.77|
72491080|NCT02595723|144510462|OTHER|||||||0.003||||||Overall group difference adjusted for prior group, time, and baseline values.|Mixed Models Analysis|Model includes prior group, time, and baseline values to control for possible effects.||||||0.003
72491081|NCT00004259|144510463|SUPERIORITY||Hazard Ratio (HR)|0.94||||0.36|TWO_SIDED|95.0|0.67|1.32|||Log Rank|||The hypothesized median survival time was 36 months for the RT+BCNU/CCNU arm and 54 months for the RT+TMZ arm, corresponding to a hazard ratio (HR) of 0.67. A sample size of 216 evaluable patients per arm would provide 90% power with a one-sided significance level of 0.05. The final analysis was planned after 155 deaths were observed. Interim efficacy analyses were planned after 52 and 104 deaths, with an interim futility analysis planned at 128 deaths.||1.32|0.67|0.36
72517167|NCT02528253|144564405|SUPERIORITY||Odds Ratio (OR)|1.56||||0.0033|TWO_SIDED|95.0|1.16|2.1|||Regression, Logistic|||Week 8: OR and 95% CI estimated from logistic regression model. Logistic regression model included treatment as fixed effect and baseline average LBPI, baseline PGA, and baseline RMDQ as covariates.||2.10|1.16|0.0033
72404885|NCT00782210|144317139|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.28|STANDARD_ERROR_OF_MEAN|0.039|<|0.0001||95.0|0.203|0.358|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.358|0.203|<0.0001
72491082|NCT00004259|144510465|SUPERIORITY||Hazard Ratio (HR)|0.8||||0.46|TWO_SIDED|95.0|0.55|1.16||2-sided|Gray's test||Reference level = RT + BCNU/CCNU|||1.16|0.55|0.46
72491083|NCT00004259|144510466|SUPERIORITY||||||<|0.001||||||2-sided|Chi-squared|||Overall toxicity||||<0.001
72491084|NCT00004259|144510466|SUPERIORITY|||||||0.76||||||2-sided|Chi-squared|||Non-hematologic toxicity||||0.76
72491085|NCT00004259|144510467|SUPERIORITY||Hazard Ratio (HR)|1.78||||0.08|TWO_SIDED|95.0|0.93|3.4|||Log Rank|Two-side significance level = 0.05|Reference level = Methylated MGMT|||3.40|0.93|0.08
72491086|NCT00004259|144510468|SUPERIORITY||Hazard Ratio (HR)|1.29||||0.41|TWO_SIDED|95.0|0.7|2.35|||Log Rank|Two-sided confidence interval = 0.5|Reference level = Methylated|||2.35|0.70|0.41
72491087|NCT00385255|144510490|NON_INFERIORITY|Non-inferiority was defined as the lower limit of the 95% confidence interval (CI) for the difference between the two groups (Boostrix+Fluarix 19-64 YOA Group minus Fluarix Boostrix 19-64 YOA Group), in terms of percentages of subjects with anti-D antibody concentrations ≥ 0.1 IU/mL, being ≥ - 10%.|Difference in percentage|1.06|||||TWO_SIDED|95.0|-1.36|3.56||||||Difference in seroprotection rates against diphteria toxoid: To demonstrate that the immunogenicity of Boostrix® vaccine co-administered with Fluarix® vaccine (Boostrix+Fluarix 19-64 YOA Group) at Day 0, was non-inferior to that of Boostrix® vaccine administered alone at Month 1 (Fluarix Boostrix 19-64 YOA Group), in terms of seroprotection rates for anti-D antibody, one month post-Boostrix® vaccination.||3.56|-1.36|
72491088|NCT00385255|144510490|NON_INFERIORITY|Non-inferiority was defined as the lower limit of the 95% CI for the difference between the two groups (Boostrix+ Fluarix 19-64 YOA Group minus Fluarix Boostrix 19-64 YOA Group), in terms of percentage of subjects with anti-T antibody concentrations ≥ 0.1 IU/mL, being ≥ - 10%.|Difference in percentage|-1.67|||||TWO_SIDED|95.0|-2.96|-0.74||||||Difference in seroprotection rates against tetanus toxoid: To demonstrate that the immunogenicity of Boostrix® vaccine co-administered with Fluarix® vaccine (Boostrix+Fluarix 19-64 YOA Group) at Day 0, was non-inferior to that of Boostrix® vaccine administered alone at Month 1 (Fluarix Boostrix 19-64 YOA Group), in terms of seroprotection rates for anti-T antibody, one month post-Boostrix® vaccination.||-0.74|-2.96|
72491089|NCT00385255|144510491|NON_INFERIORITY|Non-inferiority was defined as the lower limit of the 95% CI for the difference between the two groups (Boostrix+Fluarix 19-64 YOA Group minus Fluarix Boostrix 19-64 YOA Group), in terms of percentage of subjects with anti-T antibody concentrations ≥ 1.0 IU/mL, being ≥ - 10%.|Difference in percentage|1.4|||||TWO_SIDED|95.0|-0.77|3.68||||||Difference in seropositivity rates against tetanus toxoid: To demonstrate that the immunogenicity of Boostrix® vaccine co-administered with Fluarix® vaccine (Boostrix+Fluarix 19-64 YOA Group) at Day 0, was non-inferior to that of Boostrix® vaccine administered alone at Month 1 (Fluarix Boostrix 19-64 YOA Group), in terms of seropositivity rates for anti-T antibody, one month post-Boostrix® vaccination.||3.68|-0.77|
72404886|NCT00782210|144317140|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.251|STANDARD_ERROR_OF_MEAN|0.04|<|0.0001||95.0|0.174|0.329|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.329|0.174|<0.0001
72404887|NCT00782210|144317140|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.26|STANDARD_ERROR_OF_MEAN|0.04|<|0.0001||95.0|0.183|0.338|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.338|0.183|<0.0001
72404888|NCT00782210|144317141|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.232|STANDARD_ERROR_OF_MEAN|0.04|<|0.0001||95.0|0.153|0.31|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.310|0.153|<0.0001
72404889|NCT00782210|144317141|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.232|STANDARD_ERROR_OF_MEAN|0.04|<|0.0001||95.0|0.154|0.311|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.311|0.154|<0.0001
72404890|NCT00782210|144317142|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.247|STANDARD_ERROR_OF_MEAN|0.04|<|0.0001||95.0|0.168|0.327|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.327|0.168|<0.0001
72491090|NCT00385255|144510492|NON_INFERIORITY|Non-inferiority was defined as the lower limit of the 95% CI for GMC ratios of antibodies against the pertussis toxoid (PT) antigens between the two groups (Boostrix+Fluarix 19-64 YOA Group minus Fluarix Boostrix 19-64 YOA Group) being ≥ 0.67.|Adjusted GMC ratio|0.74|||||TWO_SIDED|95.0|0.67|0.82|||ANCOVA|||Difference in adjusted GMC ratios for anti-PT antibody: To demonstrate that the immunogenicity of Boostrix® vaccine co-administered with Fluarix® vaccine (Boostrix+Fluarix 19-64 YOA Group) at Day 0, was non-inferior to that of Boostrix® vaccine administered alone at Month 1 (Fluarix Boostrix 19-64 YOA Group), in terms of geometric mean concentrations (GMCs) for anti-PT antibody, one month post-Boostrix® vaccination.||0.82|0.67|
72491091|NCT00385255|144510492|NON_INFERIORITY|Non-inferiority was defined as the lower limit of the 95% CI for GMC ratios of antibodies against the filamentous hemagglutinin (FHA) antigens between the two groups (Boostrix+Fluarix 19-64 YOA Group minus Fluarix Boostrix 19-64 YOA Group) being ≥ 0.67.|Adjusted GMC ratio|0.71|||||TWO_SIDED|95.0|0.64|0.79|||ANCOVA|||Difference in adjusted GMC ratio for anti-FHA antibody: To demonstrate that the immunogenicity of Boostrix® vaccine co-administered with Fluarix® vaccine (Boostrix+Fluarix 19-64 YOA Group) at Day 0, was non-inferior to that of Boostrix® vaccine administered alone at Month 1 (Fluarix Boostrix 19-64 YOA Group), in terms of geometric mean concentrations (GMCs) for anti-FHA antibody, one month post-Boostrix® vaccination.||0.79|0.64|
72491092|NCT00385255|144510492|NON_INFERIORITY|Non-inferiority was defined as the lower limit of the 95% CI for GMC ratios of antibodies against the pertactin (PRN) antigens between the two groups (Boostrix+Fluarix 19-64 YOA Group minus Fluarix Boostrix 19-64 YOA Group) being ≥ 0.67.|Adjusted GMC ratio|0.7|||||TWO_SIDED|95.0|0.6|0.81|||ANCOVA|||Difference in adjusted GMC ratio for anti-PRN antibody: To demonstrate that the immunogenicity of Boostrix® vaccine co-administered with Fluarix® vaccine (Boostrix+Fluarix 19-64 YOA Group) at Day 0, was non-inferior to that of Boostrix® vaccine administered alone at Month 1 (Fluarix Boostrix 19-64 YOA Group), in terms of geometric mean concentrations (GMCs) for anti-PRN antibody, one month post-Boostrix® vaccination.||0.81|0.60|
72404891|NCT00782210|144317142|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.26|STANDARD_ERROR_OF_MEAN|0.041|<|0.0001||95.0|0.181|0.34|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.340|0.181|<0.0001
72517168|NCT02528253|144564405|SUPERIORITY||Odds Ratio (OR)|1.41||||0.0179|TWO_SIDED|95.0|1.06|1.88|||Regression, Logistic|||Week 16: OR and 95% CI estimated from logistic regression model. Logistic regression model included treatment as fixed effect and baseline average LBPI, baseline PGA, and baseline RMDQ as covariates.||1.88|1.06|0.0179
72404892|NCT00782210|144317143|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.302|STANDARD_ERROR_OF_MEAN|0.061|<|0.0001||95.0|0.181|0.422|||ANCOVA|Treatment, tiotropium stratum and baseline as fixed effects|Olo 5 mcg qd minus Placebo|||0.422|0.181|<0.0001
72404893|NCT00782210|144317143|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.249|STANDARD_ERROR_OF_MEAN|0.061|<|0.0001||95.0|0.128|0.37|||ANCOVA|Treatment, tiotropium stratum and baseline as fixed effects|Olo 10 mcg qd minus Placebo|||0.370|0.128|<0.0001
72404894|NCT00782210|144317144|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.357|STANDARD_ERROR_OF_MEAN|4.253||0.0018|TWO_SIDED|95.0|5.005|21.709|||ANCOVA|non-MMRM ANCOVA models by week, with treatment, tiotropium strata and baseline as fixed effects.||||21.709|5.005|0.0018
72404895|NCT00782210|144317144|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|15.457|STANDARD_ERROR_OF_MEAN|4.248||0.0003|TWO_SIDED|95.0|7.114|23.8|||ANCOVA|non-MMRM ANCOVA models by week, with treatment, tiotropium strata and baseline as fixed effects.||||23.800|7.114|0.0003
72404896|NCT00782210|144317145|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|17.186|STANDARD_ERROR_OF_MEAN|4.245|<|0.0001|TWO_SIDED|95.0|8.849|25.523|||ANCOVA|non-MMRM ANCOVA models by week, with treatment, tiotropium strata and baseline as fixed effects.||||25.523|8.849|<0.0001
72404897|NCT00782210|144317145|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.56|STANDARD_ERROR_OF_MEAN|4.226||0.0006|TWO_SIDED|95.0|6.259|22.86|||ANCOVA|non-MMRM ANCOVA models by week, with treatment, tiotropium strata and baseline as fixed effects.||||22.860|6.259|0.0006
72404898|NCT00782210|144317146|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.52|STANDARD_ERROR_OF_MEAN|0.182||0.0045|TWO_SIDED|95.0|-0.878|-0.162|||ANCOVA|non-MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.||||-0.162|-0.878|0.0045
72404899|NCT00782210|144317146|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.648|STANDARD_ERROR_OF_MEAN|0.182||0.0004|TWO_SIDED|95.0|-1.005|-0.291|||ANCOVA|non-MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.||||-0.291|-1.005|0.0004
72404900|NCT00782210|144317147|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.582|STANDARD_ERROR_OF_MEAN|0.202||0.0041|TWO_SIDED|95.0|-0.979|-0.185|||ANCOVA|non-MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.||||-0.185|-0.979|0.0041
72404901|NCT00782210|144317147|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.792|STANDARD_ERROR_OF_MEAN|0.202||0.0001|TWO_SIDED|95.0|-1.189|-0.394|||ANCOVA|non-MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.||||-0.394|-1.189|0.0001
72404902|NCT00782210|144317148|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.104|STANDARD_ERROR_OF_MEAN|0.354||0.0019|TWO_SIDED|95.0|-1.799|-0.409|||ANCOVA|non-MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.||||-0.409|-1.799|0.0019
72491093|NCT00385255|144510493|NON_INFERIORITY|Non-inferiority was defined as the lower limit of the 95% CI for the difference between the two groups (Boostrix+Fluarix 19-64 YOA Group minus Fluarix Boostrix 19-64 YOA Group), in terms of percentage of subjects with anti-H1N1 antibody titers ≥ 1:40 being ≥ -10%.|Difference in percentage|-1.17|||||TWO_SIDED|95.0|-3.58|1.23||||||Difference in percentage of subjects with anti-H1N1 antibody titers ≥ 1:40: To demonstrate that the immunogenicity of Boostrix® vaccine co-administered with Fluarix® vaccine (Boostrix+Fluarix 19-64 YOA Group) at Day 0, was non-inferior to that of Fluarix® vaccine administered alone at Day 0 (Fluarix Boostrix 19-64 YOA Group), in terms of percentage of subjects with anti-H1N1 antibody titers ≥ 1:40, one month post-Fluarix® vaccination.||1.23|-3.58|
72491094|NCT00385255|144510493|NON_INFERIORITY|Non-inferiority was defined as the lower limit of the 95% CI for the difference between the two groups (Boostrix+Fluarix 19-64 YOA Group minus Fluarix Boostrix 19-64 YOA Group), in terms of percentage of subjects with anti-H3N2 antibody titers ≥ 1:40 being ≥ -10%.|Difference in percentage|-0.61|||||TWO_SIDED|95.0|-2.22|0.96||||||Difference in percentage of subjects with anti-H3N2 antibody titers ≥ 1:40: To demonstrate that the immunogenicity of Boostrix® vaccine co-administered with Fluarix® vaccine (Boostrix+Fluarix 19-64 YOA Group) at Day 0, was non-inferior to that of Fluarix® vaccine administered alone at Day 0 (Fluarix Boostrix 19-64 YOA Group), in terms of percentage of subjects with anti-H3N2 antibody titers ≥ 1:40, one month post-Fluarix® vaccination.||0.96|-2.22|
72491095|NCT00385255|144510493|NON_INFERIORITY|Non-inferiority was defined as the lower limit of the 95% CI for the difference between the two groups (Boostrix+Fluarix 19-64 YOA Group minus Fluarix Boostrix 19-64 YOA Group), in terms of percentage of subjects with anti-B antibody titers ≥ 1:40 being ≥ -10%.|Difference in percentage|-0.55|||||TWO_SIDED|95.0|-2.52|1.42||||||Difference in percentage of subjects with anti-B antibody titers ≥ 1:40: To demonstrate that the immunogenicity of Boostrix® vaccine co-administered with Fluarix® vaccine (Boostrix+Fluarix 19-64 YOA Group) at Day 0, was non-inferior to that of Fluarix® vaccine administered alone at Day 0 (Fluarix Boostrix 19-64 YOA Group), in terms of percentage of subjects with anti-B antibody titers ≥ 1:40, one month post-Fluarix® vaccination.||1.42|-2.52|
72517169|NCT02528253|144564405|SUPERIORITY||Odds Ratio (OR)|1.56||||0.0021|TWO_SIDED|95.0|1.18|2.08|||Regression, Logistic|||Week 16: OR and 95% CI estimated from logistic regression model. Logistic regression model included treatment as fixed effect and baseline average LBPI, baseline PGA, and baseline RMDQ as covariates.||2.08|1.18|0.0021
72404903|NCT00782210|144317148|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.435|STANDARD_ERROR_OF_MEAN|0.354|<|0.0001|TWO_SIDED|95.0|-2.13|-0.74|||ANCOVA|non-MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.||||-0.740|-2.130|<0.0001
72404904|NCT00782210|144317149|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001||95.0|-0.7|-0.3|||Mixed Models Analysis|Model included treatment, tiotropium stratum, visit and treatment-by-visit interaction as fixed effects, patient as random.|Olo 5 mcg qd minus Placebo|||-0.3|-0.7|<0.0001
72404905|NCT00782210|144317149|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001||95.0|-0.7|-0.3|||Mixed Models Analysis|Model included treatment, tiotropium stratum, visit and treatment-by-visit interaction as fixed effects, patient as random.|Olo 10 mcg qd minus Placebo|||-0.3|-0.7|<0.0001
72404906|NCT00782210|144317150|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001||95.0|-0.7|-0.2|||Mixed Models Analysis|Model included treatment, tiotropium stratum, visit and treatment-by-visit interaction as fixed effects, patient as random.|Olo 5 mcg qd minus Placebo|||-0.2|-0.7|<0.0001
72404907|NCT00782210|144317150|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001||95.0|-0.6|-0.2|||Mixed Models Analysis|Model included treatment, tiotropium stratum, visit and treatment-by-visit interaction as fixed effects, patient as random.|Olo 10 mcg qd minus Placebo|||-0.2|-0.6|<0.0001
72404908|NCT00782210|144317151|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001||95.0|-0.7|-0.2|||Mixed Models Analysis|Model included treatment, tiotropium stratum, visit and treatment-by-visit interaction as fixed effects, patient as random.|Olo 5 mcg qd minus Placebo|||-0.2|-0.7|<0.0001
72491096|NCT00385255|144510494|NON_INFERIORITY|Non-inferiority was defined as the lower limit of the 95% CI for the difference between the two groups (Boostrix+Fluarix 19-64 YOA Group minus Fluarix Boostrix 19-64 YOA Group), in terms of percentage of subjects with ≥ 4-fold increase in anti-H1N1 antibody titers (seroconversion) being ≥ -10%.|Difference in seroconversion rate|2.37|||||TWO_SIDED|95.0|-2.84|7.58||||||Difference in seroconversion rates for anti-H1N1 antibody: To demonstrate that the immunogenicity of Boostrix® vaccine co-administered with Fluarix® vaccine (Boostrix+Fluarix 19-64 YOA Group) at Day 0, was non-inferior to that of Fluarix® vaccine administered alone at Day 0 (Fluarix Boostrix 19-64 YOA Group), in terms of seroconversion rates for anti-H1N1 antibody, one month post-Fluarix® vaccination.||7.58|-2.84|
72491097|NCT00385255|144510494|NON_INFERIORITY|Non-inferiority was defined as the lower limit of the 95% CI for the difference between the two groups (Boostrix+Fluarix 19-64 YOA Group minus Fluarix Boostrix 19-64 YOA Group), in terms of percentage of subjects with ≥ 4-fold increase in anti-H3N2 antibody titers (seroconversion) being ≥ -10%.|Difference in seroconversion rate|5.58|||||TWO_SIDED|95.0|1.1|10.07||||||Difference in seroconversion rates for anti-H3N2 antibody: To demonstrate that the immunogenicity of Boostrix® vaccine co-administered with Fluarix® vaccine (Boostrix+Fluarix 19-64 YOA Group) at Day 0, was non-inferior to that of Fluarix® vaccine administered alone at Day 0 (Fluarix Boostrix 19-64 YOA Group), in terms of seroconversion rates for anti-H3N2 antibody, one month post-Fluarix® vaccination.||10.07|1.10|
72491098|NCT00385255|144510494|NON_INFERIORITY|Non-inferiority was defined as the lower limit of the 95% CI for the difference between the two groups (Boostrix+Fluarix 19-64 YOA Group minus Fluarix Boostrix 19-64 YOA Group), in terms of percentage of subjects with ≥ 4-fold increase anti-B antibody titers (seroconversion) being ≥ -10%.|Difference in seroconversion rate|2.15|||||TWO_SIDED|95.0|-2.9|7.2||||||Difference in seroconversion rates for anti-B antibody: To demonstrate that the immunogenicity of Boostrix® vaccine co-administered with Fluarix® vaccine (Boostrix+Fluarix 19-64 YOA Group) at Day 0, was non-inferior to that of Fluarix® vaccine administered alone at Day 0 (Fluarix Boostrix 19-64 YOA Group), in terms of seroconversion rates for anti-B antibody, one month post-Fluarix® vaccination.||7.20|-2.90|
72491099|NCT02079987|144510521|SUPERIORITY|||||||0.49|||||||difference-in-difference analysis|A propensity weighted difference-in-difference approach was taken to account for imbalances in assignment and loss to follow-up.||||||0.49
72404909|NCT00782210|144317151|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001||95.0|-0.7|-0.2|||Mixed Models Analysis|Model included treatment, tiotropium stratum, visit and treatment-by-visit interaction as fixed effects, patient as random.|Olo 10 mcg qd minus Placebo|||-0.2|-0.7|<0.0001
72491100|NCT02079987|144510522|SUPERIORITY|||||||0.23|||||||difference-in-difference analysis|A propensity weighted difference-in-difference approach was taken to account for imbalances in assignment and loss to follow-up.||||||0.23
72624678|NCT01346592|144778963|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (B strain)|2.76|||||TWO_SIDED|95.0|1.44|5.3||||||At risk subjects.||5.3|1.44|
72404910|NCT00782210|144317152|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.1||0.0109||95.0|-0.5|-0.1|||Mixed Models Analysis|Model included treatment, tiotropium stratum,visit and treatment-by-visit interaction as fixed effects, patient as random.|Olo 5 mcg qd minus Placebo|||-0.1|-0.5|0.0109
72491101|NCT02079987|144510523|SUPERIORITY|||||||0.25||||||A propensity weighted difference-in-difference approach was taken to account for imbalances in assignment and loss to follow-up.|difference-in-difference analysis|||||||0.25
72491102|NCT02079987|144510524|SUPERIORITY|||||||0.03|||||||Chi-squared|||||||0.03
72624679|NCT01346592|144778963|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (H1N1 strain)|2.81|||||TWO_SIDED|95.0|2.34|3.37||||||No risk subjects.||3.37|2.34|
72404911|NCT00782210|144317152|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.1||0.0031||95.0|-0.6|-0.1|||Mixed Models Analysis|Model included treatment, tiotropium stratum visit and treatment-by-visit interaction as fixed effects, patient as random.|Olo 10 mcg qd minus Placebo|||-0.1|-0.6|0.0031
72404912|NCT00782210|144317153|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.728|STANDARD_ERROR_OF_MEAN|0.124||0.0658|TWO_SIDED|95.0|0.522|1.016|||Regression, Cox|Model included a stratification factor for tiotropium use stratum and a covariate for treatment group|Comparison of Olo 5 mcg qd to placebo across stratum|||1.016|0.522|0.0658
72404913|NCT00782210|144317153|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.799|STANDARD_ERROR_OF_MEAN|0.133||0.1701|TWO_SIDED|95.0|0.576|1.107|||Regression, Cox|Model included a stratification factor for tiotropium use stratum and a covariate for treatment group|Comparison of Olo 10 mcg qd to placebo across stratum|||1.107|0.576|0.1701
72491103|NCT02079987|144510525|SUPERIORITY|||||||0.57|||||||Chi-squared|||||||0.57
72491104|NCT02079987|144510526|SUPERIORITY|||||||0.87|||||||Chi-squared|||||||0.87
72624680|NCT01346592|144778963|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (H3N2 strain)|2.04|||||TWO_SIDED|95.0|1.83|2.28||||||No risk subjects.||2.28|1.83|
72569137|NCT03914950|144669398|OTHER|"The calculation of power and sample size is based on a formula that selects the sample size so that the lower limit of the 95% confidence interval by the expected specificity of the new method most probably exceeds the specificity value of the current method.~Receiver operating characteristics (ROC) analysis of the values of SUVmax of the early and delayed images with and without TOF of all pancreatic lesions was done in correlation with the histopathological findings."||||||0.78|||||||DeLong-test|The threshold for statistical significance was p=0.05.||It was calculated that 118 participants would have at least 90% power to demonstrate an improvement in specificity of 25% (to 70%) with the new method assuming a specificity of the current method of 45% at a prevalence of malignant lesions of 70% (corresponding to 30% benign lesions). Assumptions included a discontinuation rate of 25%.||||0.78
72569138|NCT03914950|144669398|OTHER|||||||0.95|||||||DeLong-test|The threshold for statistical significance was p=0.05.||||||0.95
72569139|NCT02566993|144669420|SUPERIORITY||Hazard Ratio (HR)|0.967||||0.9029|TWO_SIDED|95.0|0.815|1.148|||Log Rank|Stratified log-rank test||||1.148|0.815|0.9029
72569140|NCT02566993|144669421|SUPERIORITY|||||||0.2826|||||||Normal test|||||||0.2826
72569141|NCT02566993|144669422|SUPERIORITY|||||||0.6216|||||||Normal test|||||||0.6216
72569142|NCT02566993|144669423|SUPERIORITY|||||||0.9708|||||||Normal test|||||||0.9708
72569143|NCT02566993|144669424|SUPERIORITY||Hazard Ratio (HR)|0.831||||0.3257|TWO_SIDED|95.0|0.693|0.996|||Log Rank|Stratified log-rank test||||0.996|0.693|0.3257
72624681|NCT01346592|144778963|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (B strain)|3.74|||||TWO_SIDED|95.0|3.22|4.34||||||No risk subjects||4.34|3.22|
72624682|NCT01346592|144778963|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (H1N1 strain)|2.34|||||TWO_SIDED|95.0|0.92|6.0||||||At risk subjects.||6|0.92|
72624683|NCT01346592|144778963|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (H3N2 strain)|2.93|||||TWO_SIDED|95.0|1.57|5.45||||||At risk subjects.||5.45|1.57|
72624684|NCT01346592|144778963|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (B strain)|5.55|||||TWO_SIDED|95.0|2.52|12.0||||||At risk subjects||12|2.52|
72624685|NCT01346592|144778963|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (H1N1 strain)|3.66|||||TWO_SIDED|95.0|3.05|4.39||||||No risk subjects.||4.39|3.05|
72404914|NCT00782210|144317154|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.656|STANDARD_ERROR_OF_MEAN|0.247||0.2754|TWO_SIDED|95.0|0.313|1.374|||Regression, Cox|Model included a stratification factor for tiotropium use stratum and a covariate for treatment group|Comparison of Olo 5 mcg qd to placebo across stratum|||1.374|0.313|0.2754
72569144|NCT02566993|144669425|SUPERIORITY|||||||0.0851|||||||Normal test|||||||0.0851
72569145|NCT02566993|144669426|SUPERIORITY|||||||0.0129|||||||Normal test|||||||0.0129
72569146|NCT02566993|144669428|SUPERIORITY|||||||0.6616|||||||Binomial test|||||||0.6616
72569147|NCT02566993|144669429|SUPERIORITY||Hazard Ratio (HR)|0.581||||0.0012|TWO_SIDED|95.0|0.416|0.812|||Log Rank|||||0.812|0.416|0.0012
72569148|NCT02566993|144669430|SUPERIORITY||Hazard Ratio (HR)|0.921|||||TWO_SIDED|95.0|0.744|1.14||||||||1.140|0.744|
72569149|NCT02566993|144669431|SUPERIORITY||Hazard Ratio (HR)|0.688|||||TWO_SIDED|95.0|0.549|0.863||||||||0.863|0.549|
72569150|NCT02566993|144669433|SUPERIORITY||Hazard Ratio (HR)|0.921|||||TWO_SIDED|95.0|0.616|1.376||||||||1.376|0.616|
72569151|NCT02566993|144669434|SUPERIORITY||Hazard Ratio (HR)|0.504|||||TWO_SIDED|95.0|0.346|0.736||||||||0.736|0.346|
72569152|NCT02566993|144669435|SUPERIORITY||Hazard Ratio (HR)|1.122|||||TWO_SIDED|95.0|0.84|1.5||||||||1.500|0.840|
72569153|NCT02566993|144669436|SUPERIORITY||Hazard Ratio (HR)|1.306|||||TWO_SIDED|95.0|0.955|1.786||||||||1.786|0.955|
72569154|NCT02566993|144669438|SUPERIORITY||Hazard Ratio (HR)|0.915|||||TWO_SIDED|95.0|0.455|1.843||||||||1.843|0.455|
72569155|NCT02566993|144669439|SUPERIORITY||Hazard Ratio (HR)|1.092|||||TWO_SIDED|95.0|0.506|2.36||||||||2.360|0.506|
72569156|NCT02566993|144669440|SUPERIORITY||Hazard Ratio (HR)|0.923|||||TWO_SIDED|95.0|0.765|1.113||||||||1.113|0.765|
72569157|NCT02566993|144669441|SUPERIORITY||Hazard Ratio (HR)|0.788|||||TWO_SIDED|95.0|0.645|0.961||||||||0.961|0.645|
72569158|NCT02566993|144669443|SUPERIORITY||Hazard Ratio (HR)|0.903|||||TWO_SIDED|95.0|0.624|1.307||||||||1.307|0.624|
72569159|NCT02566993|144669444|SUPERIORITY||Hazard Ratio (HR)|0.56|||||TWO_SIDED|95.0|0.392|0.799||||||||0.799|0.392|
72569160|NCT02566993|144669445|SUPERIORITY||Hazard Ratio (HR)|1.291|||||TWO_SIDED|95.0|0.838|1.99||||||||1.990|0.838|
72569161|NCT02566993|144669446|SUPERIORITY||Hazard Ratio (HR)|1.29|||||TWO_SIDED|95.0|0.824|2.019||||||||2.019|0.824|
72569162|NCT02566993|144669448|SUPERIORITY||Hazard Ratio (HR)|1.032|||||TWO_SIDED|95.0|0.403|2.641||||||||2.641|0.403|
72569163|NCT02566993|144669449|SUPERIORITY||Hazard Ratio (HR)|1.013|||||TWO_SIDED|95.0|0.373|2.75||||||||2.750|0.373|
72569164|NCT03127644|144669462|SUPERIORITY||Treatment difference in slopes|-0.00496|STANDARD_ERROR_OF_MEAN|0.00038|<|0.0001|TWO_SIDED|95.0|-0.00571|-0.0042|||Mixed Models Analysis|Confirmatory testing proceeded sequentially (ZS 10g TID, then ZS 5g TID).|Negative exponential rate of change relative to placebo indicates more rapid reduction (correction) of S-K.|Exponential rate of change in S-K through to 48 hours was analysed with a mixed effect model (random slope model).||-0.00420|-0.00571|<0.0001
72569165|NCT03127644|144669462|SUPERIORITY||Treatment difference in slopes|-0.00261|STANDARD_ERROR_OF_MEAN|0.000385|<|0.001|TWO_SIDED|95.0|-0.00337|-0.00185|||Mixed Models Analysis|Confirmatory testing proceeded sequentially (ZS 10g TID, then ZS 5g TID).|Negative exponential rate of change relative to placebo indicates more rapid reduction (correction) of S-K.|Exponential rate of change in S-K through to 48 hours was analysed with a mixed effect model (random slope model).||-0.00185|-0.00337|<0.001
72569166|NCT03127644|144669463|SUPERIORITY||Odds Ratio (OR)|46.495|||<|0.0001|TWO_SIDED|95.0|10.142|213.152|||Regression, Logistic|||Logistic regression model including treatment and baseline S-K as explanatory variables was used.||213.152|10.142|<0.0001
72569167|NCT03127644|144669463|SUPERIORITY||Odds Ratio (OR)|71.835|||<|0.0001|TWO_SIDED|95.0|13.497|382.337|||Regression, Logistic|||Logistic regression model including treatment and baseline S-K as explanatory variables was used.||382.337|13.497|<0.0001
72517170|NCT02528253|144564405|SUPERIORITY||Odds Ratio (OR)|1.06||||0.6629|TWO_SIDED|95.0|0.81|1.38|||Regression, Logistic|||Week 16: OR and 95% CI estimated from logistic regression model. Logistic regression model included treatment as fixed effect and baseline average LBPI, baseline PGA, and baseline RMDQ as covariates.||1.38|0.81|0.6629
72517171|NCT02528253|144564405|SUPERIORITY||Odds Ratio (OR)|1.35||||0.0251|TWO_SIDED|95.0|1.04|1.75|||Regression, Logistic|||Week 24: OR and 95% CI estimated from logistic regression model. Logistic regression model included treatment as fixed effect and baseline average LBPI, baseline PGA, and baseline RMDQ as covariates.||1.75|1.04|0.0251
72569168|NCT03127644|144669464|SUPERIORITY||Treatment difference in slopes|-0.00231|STANDARD_ERROR_OF_MEAN|0.000645||0.0004|TWO_SIDED|95.0|-0.00359|-0.00104|||Mixed Models Analysis||Negative exponential rate of change relative to placebo indicates more rapid reduction (correction) of S-K.|Exponential rate of change in S-K through to 24 hours was analysed with a mixed effect model (random slope model).||-0.00104|-0.00359|0.0004
72569169|NCT03127644|144669464|OTHER||Treatment difference in slopes|-0.00401|STANDARD_ERROR_OF_MEAN|0.000637|<|0.0001|TWO_SIDED|95.0|-0.00527|-0.00275|||Mixed Models Analysis||Negative exponential rate of change relative to placebo indicates more rapid reduction (correction) of S-K.|Exponential rate of change in S-K through to 24 hours was analysed with a mixed effect model (random slope model).||-0.00275|-0.00527|<0.0001
72569170|NCT03127644|144669465|SUPERIORITY||Odds Ratio (OR)|1.347||||0.6167|TWO_SIDED|95.0|0.419|4.329|||Regression, Logistic|||Logistic regression model including treatment and baseline S-K as explanatory variables was used.||4.329|0.419|0.6167
72569171|NCT03127644|144669465|SUPERIORITY||Odds Ratio (OR)|15.334|||<|0.0001|TWO_SIDED|95.0|4.006|58.697|||Regression, Logistic|||Logistic regression model including treatment and baseline S-K as explanatory variables was used.||58.697|4.006|<0.0001
72569172|NCT03127644|144669469|SUPERIORITY|||||||0.0586||||||Nominal p value|Log Rank|||||||0.0586
72569173|NCT03127644|144669469|SUPERIORITY|||||||0.0006||||||Nominal p value|Log Rank|||||||0.0006
72569174|NCT03127644|144669470|SUPERIORITY|||||||0.025||||||Nominal p value|Log Rank|||||||0.0250
72404915|NCT00782210|144317154|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.01|STANDARD_ERROR_OF_MEAN|0.342||0.9792|TWO_SIDED|95.0|0.521|1.961|||Regression, Cox|Model included a stratification factor for tiotropium use stratum and a covariate for treatment group|Comparison of Olo 10 mcg qd to placebo across stratum|||1.961|0.521|0.9792
72517172|NCT02528253|144564405|SUPERIORITY||Odds Ratio (OR)|1.22||||0.1278|TWO_SIDED|95.0|0.94|1.59|||Regression, Logistic|||Week 24: OR and 95% CI estimated from logistic regression model. Logistic regression model included treatment as fixed effect and baseline average LBPI, baseline PGA, and baseline RMDQ as covariates.||1.59|0.94|0.1278
72517173|NCT02528253|144564405|SUPERIORITY||Odds Ratio (OR)|1.27||||0.0749|TWO_SIDED|95.0|0.98|1.65|||Regression, Logistic|||Week 32: OR and 95% CI estimated from logistic regression model. Logistic regression model included treatment as fixed effect and baseline average LBPI, baseline PGA, and baseline RMDQ as covariates.||1.65|0.98|0.0749
72569175|NCT03127644|144669470|SUPERIORITY|||||||0.0064||||||Nominal p value|Log Rank|||||||0.0064
72569176|NCT01156142|144669471|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.4|||<|0.001|TWO_SIDED|95.0|-6.7|-2.1|||Wilcoxon (Mann-Whitney)|||||-2.1|-6.7|<0.001
72569177|NCT01156142|144669472|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.6||||0.0018|TWO_SIDED|95.0|0.1|5.1|||Wilcoxon (Mann-Whitney)|||||5.1|0.1|0.0018
72569178|NCT01156142|144669473|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.6||||0.001|TWO_SIDED|95.0|2.9|8.3|||Wilcoxon (Mann-Whitney)|||||8.3|2.9|0.001
72569179|NCT01156142|144669474|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.7||||0.0297|TWO_SIDED|95.0|-1.2|4.6|||Wilcoxon (Mann-Whitney)|||||4.6|-1.2|0.0297
72569180|NCT01156142|144669475|SUPERIORITY_OR_OTHER|||||||0.1392|||||||Chi-squared|||At 2 hours after initial mouthwash||||0.1392
72569181|NCT01156142|144669475|SUPERIORITY_OR_OTHER|||||||0.6989|||||||Chi-squared|||At 4 hours after initial mouthwash||||0.6989
72569182|NCT01156142|144669476|SUPERIORITY_OR_OTHER|||||||0.0018|||||||Chi-squared|||||||0.0018
72569183|NCT02337959|144669524|SUPERIORITY_OR_OTHER|||||||0.028|TWO_SIDED|||||Level of significance (alpha) = 0.05|t-test, 2 sided|||||||0.028
72569184|NCT02337959|144669525|SUPERIORITY_OR_OTHER|||||||0||||||level of significance (alpha) = 0.05|t-test, 1 sided|||Both the predicate and investigational images were randomized for the monitors. Predicate images could display on the left or the right and vice versa with the investigational. There were formulas in the spreadsheet that gave the preferences a numerical value, and subsequently became part of the analysis.||||0.000
72569185|NCT04988152|144669530|SUPERIORITY||Ratio of geometric least squares means|1.0724|||||TWO_SIDED|90.0|0.8519|1.35|||||The ratio of geometric LS means and 90% confidence intervals were obtained from ANCOVA model, with Cmax as the dependent variable, and ethnicity and body weight were covariates.|||1.3500|0.8519|
72569186|NCT04988152|144669531|OTHER||Ratio of geometric least squares means|1.0513|||||TWO_SIDED|90.0|0.9281|1.1908|||||The ratio of geometric LS means and 90% confidence intervals were obtained from ANCOVA model, with AUC(D1-29) as the dependent variable, and ethnicity and body weight were covariates.|||1.1908|0.9281|
72569187|NCT04988152|144669534|OTHER||Ratio of geometric least squares means|1.6999|||||TWO_SIDED|90.0|1.15|2.5129|||||The ratio of geometric LS means and 90% confidence intervals were obtained from ANCOVA model, with Cmax as the dependent variable, and ethnicity and body weight were covariates.|||2.5129|1.1500|
72569188|NCT04988152|144669535|OTHER||Ratio of geometric least squares means|1.5869|||||TWO_SIDED|90.0|1.1236|2.2413|||||The ratio of geometric LS means and 90% confidence intervals were obtained from ANCOVA model, with AUC(D1-29) as the dependent variable, and ethnicity and body weight were covariates.|||2.2413|1.1236|
72569189|NCT04988152|144669550|OTHER||Ratio of geometric least squares means|1.0724|||||TWO_SIDED|90.0|0.8519|1.35|||||The ratio of geometric LS means and 90% confidence intervals were obtained from ANCOVA model, with Cmax as the dependent variable, and ethnicity and body weight were covariates.|||1.3500|0.8519|
72569190|NCT04988152|144669552|OTHER||Ratio of geometric least squares means|1.0673|||||TWO_SIDED|90.0|0.9286|1.2268|||||The ratio of geometric LS means and 90% confidence intervals were obtained from ANCOVA model, with AUClast as the dependent variable, and ethnicity and body weight were covariates.|||1.2268|0.9286|
72569191|NCT04988152|144669556|OTHER||Ratio of geometric least squares means|1.6999|||||TWO_SIDED|90.0|1.15|2.5129|||||The ratio of geometric LS means and 90% confidence intervals were obtained from ANCOVA model, with Cmax as the dependent variable, and ethnicity and body weight were covariates.|||2.5129|1.1500|
72517174|NCT02528253|144564405|SUPERIORITY||Odds Ratio (OR)|1.28||||0.0633|TWO_SIDED|95.0|0.99|1.66|||Regression, Logistic|||Week 32: OR and 95% CI estimated from logistic regression model. Logistic regression model included treatment as fixed effect and baseline average LBPI, baseline PGA, and baseline RMDQ as covariates.||1.66|0.99|0.0633
72517175|NCT02528253|144564405|SUPERIORITY||Odds Ratio (OR)|1.28||||0.0626|TWO_SIDED|95.0|0.99|1.67|||Regression, Logistic|||Week 40: OR and 95% CI estimated from logistic regression model. Logistic regression model included treatment as fixed effect and baseline average LBPI, baseline PGA, and baseline RMDQ as covariates.||1.67|0.99|0.0626
72517176|NCT02528253|144564405|SUPERIORITY||Odds Ratio (OR)|1.16||||0.2727|TWO_SIDED|95.0|0.89|1.51|||Regression, Logistic|||Week 40: OR and 95% CI estimated from logistic regression model. Logistic regression model included treatment as fixed effect and baseline average LBPI, baseline PGA, and baseline RMDQ as covariates.||1.51|0.89|0.2727
72517177|NCT02528253|144564405|SUPERIORITY||Odds Ratio (OR)|1.2||||0.1749|TWO_SIDED|95.0|0.92|1.57|||Regression, Logistic|||Week 48: OR and 95% CI estimated from logistic regression model. Logistic regression model included treatment as fixed effect and baseline average LBPI, baseline PGA, and baseline RMDQ as covariates.||1.57|0.92|0.1749
72517178|NCT02528253|144564405|SUPERIORITY||Odds Ratio (OR)|1.09||||0.5239|TWO_SIDED|95.0|0.84|1.42|||Regression, Logistic|||Week 48: OR and 95% CI estimated from logistic regression model. Logistic regression model included treatment as fixed effect and baseline average LBPI, baseline PGA, and baseline RMDQ as covariates.||1.42|0.84|0.5239
72517179|NCT02528253|144564405|SUPERIORITY||Odds Ratio (OR)|1.14||||0.3336|TWO_SIDED|95.0|0.87|1.49|||Regression, Logistic|||Week 56: OR and 95% CI estimated from logistic regression model. Logistic regression model included treatment as fixed effect and baseline average LBPI, baseline PGA, and baseline RMDQ as covariates.||1.49|0.87|0.3336
72517180|NCT02528253|144564405|SUPERIORITY||Odds Ratio (OR)|1.18||||0.2163|TWO_SIDED|95.0|0.91|1.54|||Regression, Logistic|||Week 56: OR and 95% CI estimated from logistic regression model. Logistic regression model included treatment as fixed effect and baseline average LBPI, baseline PGA, and baseline RMDQ as covariates.||1.54|0.91|0.2163
72517181|NCT02528253|144564406|SUPERIORITY||Odds Ratio (OR)|1.28||||0.326|TWO_SIDED|95.0|0.78|2.08|||Regression, Logistic|||Week 2: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of low back pain, baseline average LBPI, and treatment.||2.08|0.78|0.3260
72517182|NCT02528253|144564406|SUPERIORITY||Odds Ratio (OR)|1.61||||0.0445|TWO_SIDED|95.0|1.01|2.56|||Regression, Logistic|||Week 2: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of low back pain, baseline average LBPI, and treatment.||2.56|1.01|0.0445
72569192|NCT04988152|144669558|OTHER||Ratio of geometric least squares means|1.5766|||||TWO_SIDED|90.0|1.1777|2.1106|||||The ratio of geometric LS means and 90% confidence intervals were obtained from ANCOVA model, with AUClast as the dependent variable, and ethnicity and body weight were covariates|||2.1106|1.1777|
72624686|NCT01346592|144778963|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (H3N2 strain)|2.68|||||TWO_SIDED|95.0|2.4|2.99||||||No risk subjects||2.99|2.4|
72491105|NCT01445951|144510528|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority with 0.4 margin|Mean Difference (Net)|0.19|STANDARD_ERROR_OF_MEAN|0.086|||TWO_SIDED|95.0|0.02|0.36||||||MMRM (mixed model repeated measures) model with auto-regression (1): HbA1c = Baseline HbA1c + region + basal insulin stratum + visit + treatment + (visit\*treatment)||0.36|0.02|
72491106|NCT01445951|144510529|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.01|STANDARD_ERROR_OF_MEAN|0.016|||TWO_SIDED|95.0|-0.02|0.04|||||Mixed Model Repeated Measure (MMRM): FEV1 = Baseline FEV1 + Age + Gender + Race + Baseline Height + Visit + Treatment + (Visit\*Treatment)|||0.04|-0.02|
72491107|NCT01445951|144510530|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-35.42|STANDARD_ERROR_OF_MEAN|10.622|||TWO_SIDED|95.0|-56.25|-14.59|||||MMRM: FPG = Baseline FPG + Region + Basal insulin stratum + Visit + Treatment + (Visit\*Treatment)|||-14.59|-56.25|
72491108|NCT01445951|144510533|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.32|STANDARD_ERROR_OF_MEAN|0.512||0.0102|TWO_SIDED|95.0|-2.33|-0.31|||ANCOVA|ANCOVA: Weight change from baseline = Baseline weight + Change from baseline in HbA1c + Region + Basal insulin stratum + Treatment|ANCOVA: Weight change from baseline = Baseline weight + Change from baseline in HbA1c + Region + Basal insulin stratum + Treatment|||-0.31|-2.33|0.0102
72491109|NCT01445951|144510533|SUPERIORITY_OR_OTHER|||||||0.4955|||||||t-test, 2 sided|||Within treatment analysis of change from Baseline comparing if change was different from zero||||0.4955
72491110|NCT01445951|144510533|SUPERIORITY_OR_OTHER|||||||0.6807|||||||t-test, 2 sided|||Within treatment analysis of change from Baseline comparing if change was different from zero||||0.6807
72491111|NCT01445951|144510533|SUPERIORITY_OR_OTHER|||||||0.0079|||||||t-test, 2 sided|||Within treatment analysis of change from Baseline comparing if change was different from zero||||0.0079
72491112|NCT01445951|144510535|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.5328||||0.0156|TWO_SIDED|95.0|0.3198|0.8877|||Regression, Logistic|Logistic model with affects for Region, Basal insulin stratum, and Treatment||||0.8877|0.3198|0.0156
72491113|NCT01445951|144510536|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Negative Binomial Regression|Model: Region + Basal Insulin Stratum + Treatment + Exposure Time||||||<0.0001
72517183|NCT02528253|144564406|SUPERIORITY||Odds Ratio (OR)|1.02||||0.9263|TWO_SIDED|95.0|0.65|1.61|||Regression, Logistic|||Week 2: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of low back pain, baseline average LBPI, and treatment.||1.61|0.65|0.9263
72517184|NCT02528253|144564406|SUPERIORITY||Odds Ratio (OR)|1.25||||0.3194|TWO_SIDED|95.0|0.81|1.94|||Regression, Logistic|||Week 2: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of low back pain, baseline average LBPI, and treatment.||1.94|0.81|0.3194
72569193|NCT01194973|144669603|SUPERIORITY_OR_OTHER||LS mean change from baseline|117.68|||<|0.0001|TWO_SIDED|95.0|92.77|142.59|||ANOVA|||||142.59|92.77|<0.0001
72569194|NCT01194973|144669609|SUPERIORITY_OR_OTHER||LS mean change from baseline|102.49|||<|0.0001|TWO_SIDED|95.0|68.15|136.82|||ANOVA|||||136.82|68.15|<0.0001
72569195|NCT02615171|144669673|OTHER|||||||0.0106|||||||t-test, 2 sided|||||||0.0106
72569196|NCT02615171|144669674|OTHER|||||||0.0027|||||||Chi-squared|||||||0.0027
72569197|NCT02615171|144669675|OTHER|||||||0.7829|||||||Wilcoxon rank sum test|||||||0.7829
72517185|NCT02528253|144564406|SUPERIORITY||Odds Ratio (OR)|1.58||||0.0308|TWO_SIDED|95.0|1.04|2.38|||Regression, Logistic|||Week 2: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of low back pain, baseline average LBPI, and treatment.||2.38|1.04|0.0308
72491114|NCT01445951|144510537|SUPERIORITY_OR_OTHER|||||||0.1022|||||||Negative Binomial Regression|Model: Region + Basal Insulin Stratum + Treatment + Exposure Time||||||0.1022
72491115|NCT01445951|144510538|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.449||||0.0158|TWO_SIDED|95.0|0.23|0.86|||Regression, Logistic|Model: Treatment + Basal insulin stratum + Region + Baseline HbA1c|Gen2 in the numerator, Aspart in the denominator|||0.86|0.23|0.0158
72517186|NCT02528253|144564406|SUPERIORITY||Odds Ratio (OR)|1.79||||0.0048|TWO_SIDED|95.0|1.2|2.69|||Regression, Logistic|||Week 4: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of low back pain, baseline average LBPI, and treatment.||2.69|1.20|0.0048
72517187|NCT02528253|144564406|SUPERIORITY||Odds Ratio (OR)|1.68||||0.0114|TWO_SIDED|95.0|1.12|2.51|||Regression, Logistic|||Week 4: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of low back pain, baseline average LBPI, and treatment.||2.51|1.12|0.0114
72517188|NCT02528253|144564406|SUPERIORITY||Odds Ratio (OR)|1.06||||0.7857|TWO_SIDED|95.0|0.71|1.56|||Regression, Logistic|||Week 4: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of low back pain, baseline average LBPI, and treatment.||1.56|0.71|0.7857
72517189|NCT02528253|144564406|SUPERIORITY||Odds Ratio (OR)|1.7||||0.0041|TWO_SIDED|95.0|1.18|2.44|||Regression, Logistic|||Week 4: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of low back pain, baseline average LBPI, and treatment.||2.44|1.18|0.0041
72517190|NCT02528253|144564406|SUPERIORITY||Odds Ratio (OR)|1.59||||0.0109|TWO_SIDED|95.0|1.11|2.28|||Regression, Logistic|||Week 4: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of low back pain, baseline average LBPI, and treatment.||2.28|1.11|0.0109
72517191|NCT02528253|144564406|SUPERIORITY||Odds Ratio (OR)|1.53||||0.0363|TWO_SIDED|95.0|1.03|2.27|||Regression, Logistic|||Week 8: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of low back pain, baseline average LBPI, and treatment.||2.27|1.03|0.0363
72517192|NCT02528253|144564406|SUPERIORITY||Odds Ratio (OR)|1.76||||0.004|TWO_SIDED|95.0|1.2|2.59|||Regression, Logistic|||Week 8: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of low back pain, baseline average LBPI, and treatment.||2.59|1.20|0.0040
72569198|NCT00888459|144669686|SUPERIORITY_OR_OTHER_LEGACY|||||||0.432||95.0|||||Chi-squared|||||||.432
72569199|NCT01000493|144669687|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.62||||0.3624|TWO_SIDED|95.0|-17.9|6.65||The mixed effects model repeated measures (MMRM) analysis included treatment, week, Baseline total CAPS score and the treatment by week and Baseline. Week was used as the repeated effect in the model.|MMRM analysis||Comparison between Placebo and Orvepitant 60 mg at Week 12.|||6.65|-17.9|0.3624
72491116|NCT02076997|144510539|OTHER||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||||||<0.01
72491117|NCT02076997|144510545|OTHER|||||||||||||||||There was no statistical analysis performed for this aim as it was descriptive|There was no statistical analysis performed for this aim as it was descriptive|||
72491118|NCT02076997|144510546|OTHER||Odds Ratio (OR)|6.7|||||TWO_SIDED|95.0||||||||||||
72491119|NCT03817775|144510549|OTHER||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||||||<0.01
72491120|NCT03817775|144510550|OTHER||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||||||<0.01
72491121|NCT03817775|144510551|OTHER|||||||0.7215|||||||Wilcoxon (Mann-Whitney)|||||||0.7215
72491122|NCT03817775|144510552|OTHER|||||||0.5675|||||||Wilcoxon (Mann-Whitney)|||||||0.5675
72491123|NCT03817775|144510553|OTHER||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||||||<0.01
72491124|NCT00531752|144510559|SUPERIORITY_OR_OTHER||Least Squares (LS) Mean Difference|0.7947|STANDARD_ERROR_OF_MEAN|1.8848||0.6749|TWO_SIDED|80.0|-1.649|3.2383||P-values are not adjusted for multiple comparisons.|Mixed Models Analysis||Positive value for the LS mean difference indicates the estimate favors placebo.|Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||3.2383|-1.649|0.6749
72491125|NCT00531752|144510559|SUPERIORITY_OR_OTHER||LS Mean Difference|1.4176|STANDARD_ERROR_OF_MEAN|2.0343||0.4886|TWO_SIDED|80.0|-1.218|4.0533||P-values are not adjusted for multiple comparisons.|Mixed Models Analysis||Positive value for the LS mean difference indicates the estimate favors placebo.|Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||4.0533|-1.218|0.4886
72491126|NCT00531752|144510560|SUPERIORITY_OR_OTHER||LS Mean Difference|1.025|STANDARD_ERROR_OF_MEAN|1.7713||0.5643|TWO_SIDED|80.0|-1.262|3.3121|||Mixed Models Analysis|||Week 1: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||3.3121|-1.262|0.5643
72569200|NCT01000493|144669688|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.91||||0.3156|TWO_SIDED|95.0|0.54|6.76|||Logistic regression analysis|The analysis method was logistic regression adjusted for Baseline CAPS total score.|Comparison between Placebo and Orvepitant 60 mg at Week 1. Odds ratios represent the odds of improvement, relative to placebo.|||6.76|0.54|0.3156
72569201|NCT01000493|144669688|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.64||||0.3024|TWO_SIDED|95.0|0.27|1.5|||Logistic regression analysis|The analysis method was logistic regression adjusted for Baseline CAPS total score.|Comparison between Placebo and Orvepitant 60 mg at Week 1. Odds ratios represent the odds of improvement, relative to placebo.|||1.50|0.27|0.3024
72569202|NCT01000493|144669688|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.4||||0.1208|TWO_SIDED|95.0|0.79|7.28|||Logistic regression analysis|The analysis method was logistic regression adjusted for Baseline CAPS total score.|Comparison between Placebo and Orvepitant 60 mg at Week 8. Odds ratios represent the odds of improvement, relative to placebo.|||7.28|0.79|0.1208
72404916|NCT00782210|144317155|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.739|STANDARD_ERROR_OF_MEAN|0.142||0.1194|TWO_SIDED|95.0|0.506|1.078|||Regression, Cox|Model included a stratification factor for tiotropium use stratum and a covariate for treatment group|Comparison of Olo 5 mcg qd to placebo across stratum|||1.078|0.506|0.1194
72404917|NCT00782210|144317155|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.811|STANDARD_ERROR_OF_MEAN|0.153||0.257|TWO_SIDED|95.0|0.561|1.174|||Regression, Cox|Model included a stratification factor for tiotropium use stratum and a covariate for treatment group|Comparison of Olo 10 mcg qd to placebo across stratum|||1.174|0.561|0.2570
72404918|NCT00782210|144317156|SUPERIORITY_OR_OTHER||Incidence rate ratio|0.7815|STANDARD_ERROR_OF_MEAN|0.138||0.1631|TWO_SIDED|95.0|0.5524|1.1054|||Negative binomial regression|Regression of treatment effect using tiotropium strata as a covariate, a log link function and log(exposure) as offset.|Olo 5 mcg qd minus Placebo|||1.1054|0.5524|0.1631
72491127|NCT00531752|144510560|SUPERIORITY_OR_OTHER||LS Mean Difference|1.9146|STANDARD_ERROR_OF_MEAN|1.8777||0.3107|TWO_SIDED|80.0|-0.51|4.3392|||Mixed Models Analysis|||Week 1: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||4.3392|-0.5100|0.3107
72491128|NCT00531752|144510560|SUPERIORITY_OR_OTHER||LS Mean Difference|2.3154|STANDARD_ERROR_OF_MEAN|1.4638||0.1196|TWO_SIDED|80.0|0.41601|4.2148|||Mixed Models Analysis|||Week 2: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||4.2148|0.41601|0.1196
72491129|NCT00531752|144510560|SUPERIORITY_OR_OTHER||LS Mean Difference|1.3288|STANDARD_ERROR_OF_MEAN|1.524||0.3872|TWO_SIDED|80.0|-0.649|3.3065|||Mixed Models Analysis|||Week 2: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||3.3065|-0.6490|0.3872
72491130|NCT00531752|144510565|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1677|STANDARD_ERROR_OF_MEAN|1.0269||0.8708|TWO_SIDED|80.0|-1.162|1.4971|||Mixed Models Analysis|||Week 1 (Inattention): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||1.4971|-1.162|0.8708
72491131|NCT00531752|144510565|SUPERIORITY_OR_OTHER||LS Mean Difference|1.8607|STANDARD_ERROR_OF_MEAN|1.0912||0.0927|TWO_SIDED|80.0|0.44874|3.2726|||Mixed Models Analysis|||Week 1 (Inattention): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||3.2726|0.44874|0.0927
72491132|NCT00531752|144510565|SUPERIORITY_OR_OTHER||LS Mean Difference|0.866|STANDARD_ERROR_OF_MEAN|0.9037||0.3405|TWO_SIDED|80.0|-0.3008|2.0329|||Mixed Models Analysis|||Week 1 (Hyperactivity/Impulsivity): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||2.0329|-0.3008|0.3405
72491133|NCT00531752|144510565|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1623|STANDARD_ERROR_OF_MEAN|0.9622||0.8665|TWO_SIDED|80.0|-1.08|1.4047|||Mixed Models Analysis|||Week 1 (Hyperactivity/Impulsivity): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||1.4047|-1.080|0.8665
72491134|NCT00531752|144510565|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3886|STANDARD_ERROR_OF_MEAN|0.9694||0.6901|TWO_SIDED|80.0|-0.8694|1.6466|||Mixed Models Analysis|||Week 2 (Inattention): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||1.6466|-0.8694|0.6901
72491135|NCT00531752|144510565|SUPERIORITY_OR_OTHER||LS Mean Difference|1.3779|STANDARD_ERROR_OF_MEAN|1.0114||0.179|TWO_SIDED|80.0|0.06498|2.6908|||Mixed Models Analysis|||Week 2 (Inattention): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||2.6908|0.06498|0.1790
72491136|NCT00531752|144510565|SUPERIORITY_OR_OTHER||LS Mean Difference|1.8759|STANDARD_ERROR_OF_MEAN|0.7508||0.0156|TWO_SIDED|80.0|0.90156|2.8502|||Mixed Models Analysis|||Week 2 (Hyperactivity/Impulsivity): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||2.8502|0.90156|0.0156
72491137|NCT00531752|144510565|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.04217|STANDARD_ERROR_OF_MEAN|0.7842||0.9573|TWO_SIDED|80.0|-1.06|0.97559|||Mixed Models Analysis|||Week 2 (Hyperactivity/Impulsivity): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||0.97559|-1.060|0.9573
72491138|NCT00531752|144510565|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1602|STANDARD_ERROR_OF_MEAN|1.2517||0.8986|TWO_SIDED|80.0|-1.462|1.782|||Mixed Models Analysis|||Week 3 (Inattention): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||1.7820|-1.462|0.8986
72491139|NCT00531752|144510565|SUPERIORITY_OR_OTHER||LS Mean Difference|0.6688|STANDARD_ERROR_OF_MEAN|1.3437||0.6204|TWO_SIDED|80.0|-1.071|2.4086|||Mixed Models Analysis|||Week 3 (Inattention): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||2.4086|-1.071|0.6204
72491140|NCT00531752|144510565|SUPERIORITY_OR_OTHER||LS Mean Difference|0.492|STANDARD_ERROR_OF_MEAN|0.8742||0.5759|TWO_SIDED|80.0|-0.6421|1.6261|||Mixed Models Analysis|||Week 3 (Hyperactivity/Impulsivity): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||1.6261|-0.6421|0.5759
72491141|NCT00531752|144510565|SUPERIORITY_OR_OTHER||LS Mean Difference|0.875|STANDARD_ERROR_OF_MEAN|0.9488||0.3603|TWO_SIDED|80.0|-0.3552|2.1051|||Mixed Models Analysis|||Week 3 (Hyperactivity/Impulsivity): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||2.1051|-0.3552|0.3603
72404919|NCT00782210|144317156|SUPERIORITY_OR_OTHER||Incidence rate ratio|0.8456|STANDARD_ERROR_OF_MEAN|0.1467||0.3342|TWO_SIDED|95.0|0.6015|1.1889|||Negative binomial regression|Regression of treatment effect using tiotropium strata as a covariate, a log link function and log(exposure) as offset.|Olo 10 mcg qd minus Placebo|||1.1889|0.6015|0.3342
72404920|NCT00782210|144317157|SUPERIORITY_OR_OTHER||Incidence rate ratio|0.655|STANDARD_ERROR_OF_MEAN|0.2664||0.2985|TWO_SIDED|95.0|0.2947|1.4556|||Negative binomial regression|Regression of treatment effect using tiotropium strata as a covariate, a log link function and log(exposure) as offset.|Olo 5 mcg qd minus Placebo|||1.4556|0.2947|0.2985
72517193|NCT02528253|144564406|SUPERIORITY||Odds Ratio (OR)|1.27||||0.1992|TWO_SIDED|95.0|0.88|1.84|||Regression, Logistic|||Week 8: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of low back pain, baseline average LBPI, and treatment.||1.84|0.88|0.1992
72517194|NCT02528253|144564406|SUPERIORITY||Odds Ratio (OR)|1.2||||0.3084|TWO_SIDED|95.0|0.85|1.7|||Regression, Logistic|||Week 8: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of low back pain, baseline average LBPI, and treatment.||1.70|0.85|0.3084
72517195|NCT02528253|144564406|SUPERIORITY||Odds Ratio (OR)|1.38||||0.0586|TWO_SIDED|95.0|0.99|1.94|||Regression, Logistic|||Week 8: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of low back pain, baseline average LBPI, and treatment.||1.94|0.99|0.0586
72517196|NCT02528253|144564406|SUPERIORITY||Odds Ratio (OR)|1.39||||0.063|TWO_SIDED|95.0|0.98|1.97|||Regression, Logistic|||Week 16: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of low back pain, baseline average LBPI, and treatment.||1.97|0.98|0.0630
72517197|NCT02528253|144564406|SUPERIORITY||Odds Ratio (OR)|1.45||||0.0347|TWO_SIDED|95.0|1.03|2.04|||Regression, Logistic|||Week 16: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of low back pain, baseline average LBPI, and treatment.||2.04|1.03|0.0347
72517198|NCT02528253|144564406|SUPERIORITY||Odds Ratio (OR)|0.96||||0.79|TWO_SIDED|95.0|0.69|1.33|||Regression, Logistic|||Week 16: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of low back pain, baseline average LBPI, and treatment.||1.33|0.69|0.7900
72517199|NCT02528253|144564406|SUPERIORITY||Odds Ratio (OR)|1.45||||0.0207|TWO_SIDED|95.0|1.06|2.0|||Regression, Logistic|||Week 16: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of low back pain, baseline average LBPI, and treatment.||2.00|1.06|0.0207
72517200|NCT02528253|144564406|SUPERIORITY||Odds Ratio (OR)|1.51||||0.0093|TWO_SIDED|95.0|1.11|2.07|||Regression, Logistic|||Week 16: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of low back pain, baseline average LBPI, and treatment.||2.07|1.11|0.0093
72517201|NCT02528253|144564406|SUPERIORITY||Odds Ratio (OR)|1.39||||0.04|TWO_SIDED|95.0|1.02|1.91|||Regression, Logistic|||Week 24: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of low back pain, baseline average LBPI, and treatment.||1.91|1.02|0.0400
72517202|NCT02528253|144564406|SUPERIORITY||Odds Ratio (OR)|1.21||||0.2478|TWO_SIDED|95.0|0.88|1.65|||Regression, Logistic|||Week 24: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of low back pain, baseline average LBPI, and treatment.||1.65|0.88|0.2478
72517203|NCT02528253|144564406|SUPERIORITY||Odds Ratio (OR)|1.42||||0.0304|TWO_SIDED|95.0|1.03|1.96|||Regression, Logistic|||Week 32: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of low back pain, baseline average LBPI, and treatment.||1.96|1.03|0.0304
72517204|NCT02528253|144564406|SUPERIORITY||Odds Ratio (OR)|1.12||||0.4763|TWO_SIDED|95.0|0.81|1.56|||Regression, Logistic|||Week 32: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of low back pain, baseline average LBPI, and treatment.||1.56|0.81|0.4763
72517205|NCT02528253|144564406|SUPERIORITY||Odds Ratio (OR)|1.47||||0.0178|TWO_SIDED|95.0|1.07|2.01|||Regression, Logistic|||Week 40: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of low back pain, baseline average LBPI, and treatment.||2.01|1.07|0.0178
72517206|NCT02528253|144564406|SUPERIORITY||Odds Ratio (OR)|1.11||||0.5223|TWO_SIDED|95.0|0.8|1.53|||Regression, Logistic|||Week 40: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of low back pain, baseline average LBPI, and treatment.||1.53|0.80|0.5223
72517207|NCT02528253|144564406|SUPERIORITY||Odds Ratio (OR)|1.25||||0.1708|TWO_SIDED|95.0|0.91|1.72|||Regression, Logistic|||Week 48: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of low back pain, baseline average LBPI, and treatment.||1.72|0.91|0.1708
72517208|NCT02528253|144564406|SUPERIORITY||Odds Ratio (OR)|1.09||||0.6022|TWO_SIDED|95.0|0.79|1.5|||Regression, Logistic|||Week 48: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of low back pain, baseline average LBPI, and treatment.||1.50|0.79|0.6022
72517209|NCT02528253|144564406|SUPERIORITY||Odds Ratio (OR)|1.32||||0.0846|TWO_SIDED|95.0|0.96|1.81|||Regression, Logistic|||Week 56: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of low back pain, baseline average LBPI, and treatment.||1.81|0.96|0.0846
72569203|NCT01000493|144669688|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.27||||0.1331|TWO_SIDED|95.0|0.7|15.4|||Logistic regression analysis|The analysis method was logistic regression adjusted for Baseline CAPS total score.|Comparison between Placebo and Orvepitant 60 mg at Week 1. Odds ratios represent the odds of improvement, relative to placebo.|||15.4|0.70|0.1331
72624687|NCT01346592|144778963|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (B strain)|3.97|||||TWO_SIDED|95.0|3.42|4.61||||||No risk subjects.||4.61|3.42|
72624688|NCT01346592|144778963|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (H1N1 strain)|2.72|||||TWO_SIDED|95.0|1.02|7.31||||||At risk subjects.||7.31|1.02|
72517210|NCT02528253|144564406|SUPERIORITY||Odds Ratio (OR)|1.01||||0.9626|TWO_SIDED|95.0|0.73|1.39|||Regression, Logistic|||Week 56: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of low back pain, baseline average LBPI, and treatment.||1.39|0.73|0.9626
72569204|NCT01000493|144669690|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.87||||0.7015|TWO_SIDED|95.0|-5.35|3.61||The MMRM analysis model included treatment, week, Baseline total CAPS score, and the treatment by week and Baseline by week interaction terms. Week was used as the repeated effect in the model.|MMRM analysis||Comparison between placebo and orvepitant 60 mg once daily at Week 1.|||3.61|-5.35|0.7015
72404921|NCT00782210|144317157|SUPERIORITY_OR_OTHER||Incidence rate ratio|1.1211|STANDARD_ERROR_OF_MEAN|0.4103||0.755|TWO_SIDED|95.0|0.5464|2.3003|||Negative binomial regression|Regression of treatment effect using tiotropium strata as a covariate, a log link function and log(exposure) as offset.|Olo 10 mcg qd minus Placebo|||2.3003|0.5464|0.7550
72404922|NCT00782210|144317158|SUPERIORITY_OR_OTHER||Incidence rate ratio|0.8081|STANDARD_ERROR_OF_MEAN|0.163||0.2911|TWO_SIDED|95.0|0.5438|1.2008|||Negative binomial regression|Regression of treatment effect using tiotropium strata as a covariate, a log link function and log(exposure) as offset.|Olo 5 mcg qd minus Placebo|||1.2008|0.5438|0.2911
72404923|NCT00782210|144317158|SUPERIORITY_OR_OTHER||Incidence rate ratio|0.8485|STANDARD_ERROR_OF_MEAN|0.1686||0.4086|TWO_SIDED|95.0|0.5743|1.2535|||Negative binomial regression|Regression of treatment effect using tiotropium strata as a covariate, a log link function and log(exposure) as offset.|Olo 10 mcg qd minus Placebo|||1.2535|0.5743|0.4086
72404924|NCT01675882|144317168|SUPERIORITY||Relative risk|1.81||||0.0292|TWO_SIDED|95.0|1.05|3.11|||Fisher Exact|||The three pair-wise comparisons of viaskin peanut versus placebo were analyzed using the Bonferroni stepwise procedure, keeping the overall false-positive (alpha) risk below 5%. The comparison of viaskin peanut 250 µg versus placebo is statistically significant at p\<0.05. The subsequent comparison of viaskin peanut 100 µg versus placebo is not statistically significant at p\<0.05. Thus, no conclusion can be made on the comparison of viaskin peanut 50 µg vs placebo.||3.11|1.05|0.0292
72491142|NCT00531752|144510566|SUPERIORITY_OR_OTHER||LS Mean Difference|3.5306|STANDARD_ERROR_OF_MEAN|1.6664||0.0392|TWO_SIDED|80.0|1.3659|5.6952|||Mixed Models Analysis|||Day 1: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||5.6952|1.3659|0.0392
72491143|NCT00531752|144510566|SUPERIORITY_OR_OTHER||LS Mean Difference|6.9344|STANDARD_ERROR_OF_MEAN|1.7848||0.0003|TWO_SIDED|80.0|4.6177|9.2512|||Mixed Models Analysis|||Day 1: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||9.2512|4.6177|0.0003
72624689|NCT01346592|144778963|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (H3N2 strain)|3.5|||||TWO_SIDED|95.0|1.85|6.62||||||At risk subjects.||6.62|1.85|
72624690|NCT01346592|144778963|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (B strain)|5.26|||||TWO_SIDED|95.0|2.32|12.0||||||At risk subjects.||12|2.32|
72491144|NCT00531752|144510566|SUPERIORITY_OR_OTHER||LS Mean Difference|4.2888|STANDARD_ERROR_OF_MEAN|2.1861||0.0547|TWO_SIDED|80.0|1.4544|7.1232|||Mixed Models Analysis|||Day 2: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||7.1232|1.4544|0.0547
72491145|NCT00531752|144510566|SUPERIORITY_OR_OTHER||LS Mean Difference|5.6799|STANDARD_ERROR_OF_MEAN|2.3261||0.0176|TWO_SIDED|80.0|2.6655|8.6943|||Mixed Models Analysis|||Day 2: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||8.6943|2.6655|0.0176
72491146|NCT00531752|144510566|SUPERIORITY_OR_OTHER||LS Mean Difference|0.7203|STANDARD_ERROR_OF_MEAN|2.5085||0.775|TWO_SIDED|80.0|-2.53|3.9704|||Mixed Models Analysis|||Day 3: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||3.9704|-2.530|0.7750
72491147|NCT00531752|144510566|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.04276|STANDARD_ERROR_OF_MEAN|2.6874||0.9874|TWO_SIDED|80.0|-3.521|3.4357|||Mixed Models Analysis|||Day 3: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||3.4357|-3.521|0.9874
72491148|NCT00531752|144510566|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.6252|STANDARD_ERROR_OF_MEAN|2.2268||0.7799|TWO_SIDED|80.0|-3.513|2.2629|||Mixed Models Analysis|||Day 4: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||2.2629|-3.513|0.7799
72491149|NCT00531752|144510566|SUPERIORITY_OR_OTHER||LS Mean Difference|3.1136|STANDARD_ERROR_OF_MEAN|2.3365||0.1881|TWO_SIDED|80.0|0.08338|6.1438|||Mixed Models Analysis|||Day 4: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||6.1438|0.08338|0.1881
72491150|NCT00531752|144510566|SUPERIORITY_OR_OTHER||LS Mean Difference|1.6575|STANDARD_ERROR_OF_MEAN|1.9677||0.4032|TWO_SIDED|80.0|-0.8944|4.2094|||Mixed Models Analysis|||Day 5: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||4.2094|-0.8944|0.4032
72624691|NCT01346592|144778963|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (H1N1 strain)|1.55|||||TWO_SIDED|95.0|1.21|1.97||||||No risk subjects.||1.97|1.21|
72404925|NCT01675882|144317168|SUPERIORITY||Relative risk|1.64||||0.1074|TWO_SIDED|95.0|0.95|2.85|||Fisher Exact|||The three pair-wise comparisons of viaskin peanut versus placebo were analyzed using the Bonferroni stepwise procedure, keeping the overall false-positive (alpha) risk below 5%. The comparison of viaskin peanut 250 µg versus placebo is statistically significant at p\<0.05. The subsequent comparison of viaskin peanut 100 µg versus placebo is not statistically significant at p\<0.05.||2.85|0.95|0.1074
72404926|NCT01675882|144317168|SUPERIORITY||Relative risk|2.0||||0.0108|TWO_SIDED|95.0|1.18|3.38|||Fisher Exact|||The three pair-wise comparisons of viaskin peanut versus placebo were analyzed using the Bonferroni stepwise procedure, keeping the overall false-positive (alpha) risk below 5%. The comparison of viaskin peanut 250 µg versus placebo is statistically significant at p\<0.05.||3.38|1.18|0.0108
72404927|NCT01675882|144317169|SUPERIORITY||Relative risk|2.95||||0.0035|TWO_SIDED|95.0|1.34|6.49|||Fisher Exact|||||6.49|1.34|0.0035
72404928|NCT01675882|144317169|SUPERIORITY||Relative risk|2.38||||0.0453|TWO_SIDED|95.0|1.04|5.47|||Fisher Exact|||||5.47|1.04|0.0453
72404929|NCT01675882|144317169|SUPERIORITY||Relative risk|2.77||||0.0076|TWO_SIDED|95.0|1.25|6.14|||Fisher Exact|||||6.14|1.25|0.0076
72404930|NCT01675882|144317170|SUPERIORITY||Relative risk|1.5||||0.7112|TWO_SIDED|95.0|0.51|4.43|||Fisher Exact|||||4.43|0.51|0.7112
72491151|NCT00531752|144510566|SUPERIORITY_OR_OTHER||LS Mean Difference|5.9254|STANDARD_ERROR_OF_MEAN|2.0796||0.0059|TWO_SIDED|80.0|3.2314|8.6193|||Mixed Models Analysis|||Day 5: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||8.6193|3.2314|0.0059
72491152|NCT00531752|144510566|SUPERIORITY_OR_OTHER||LS Mean Difference|1.0921|STANDARD_ERROR_OF_MEAN|2.1098||0.6067|TWO_SIDED|80.0|-1.643|3.8273|||Mixed Models Analysis|||Day 6: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||3.8273|-1.643|0.6067
72491153|NCT00531752|144510566|SUPERIORITY_OR_OTHER||LS Mean Difference|4.2785|STANDARD_ERROR_OF_MEAN|2.2424||0.0614|TWO_SIDED|80.0|1.3709|7.186|||Mixed Models Analysis|||Day 6: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||7.1860|1.3709|0.0614
72491154|NCT00531752|144510566|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.7149|STANDARD_ERROR_OF_MEAN|2.2086||0.7476|TWO_SIDED|80.0|-3.584|2.1546|||Mixed Models Analysis|||Day 7: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||2.1546|-3.584|0.7476
72491155|NCT00531752|144510566|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.3355|STANDARD_ERROR_OF_MEAN|2.4396||0.5863|TWO_SIDED|80.0|-4.499|1.8284|||Mixed Models Analysis|||Day 7: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||1.8284|-4.499|0.5863
72491156|NCT00531752|144510566|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1058|STANDARD_ERROR_OF_MEAN|2.0529||0.9591|TWO_SIDED|80.0|-2.771|2.5593|||Mixed Models Analysis|||Day 8: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||2.5593|-2.771|0.9591
72491157|NCT00531752|144510566|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4352|STANDARD_ERROR_OF_MEAN|2.2048||0.8442|TWO_SIDED|80.0|-3.294|2.4238|||Mixed Models Analysis|||Day 8: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||2.4238|-3.294|0.8442
72491158|NCT00531752|144510566|SUPERIORITY_OR_OTHER||LS Mean Difference|2.6876|STANDARD_ERROR_OF_MEAN|2.0533||0.1977|TWO_SIDED|80.0|0.01391|5.3613|||Mixed Models Analysis|||Day 9: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||5.3613|0.01391|0.1977
72491159|NCT00531752|144510566|SUPERIORITY_OR_OTHER||LS Mean Difference|1.8149|STANDARD_ERROR_OF_MEAN|2.2467||0.4235|TWO_SIDED|80.0|-1.108|4.7375|||Mixed Models Analysis|||Day 9: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||4.7375|-1.108|0.4235
72491160|NCT00531752|144510566|SUPERIORITY_OR_OTHER||LS Mean Difference|2.6424|STANDARD_ERROR_OF_MEAN|1.9753||0.1882|TWO_SIDED|80.0|0.07015|5.2147|||Mixed Models Analysis|||Day 10: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||5.2147|0.07015|0.1882
72491161|NCT00531752|144510566|SUPERIORITY_OR_OTHER||LS Mean Difference|1.2105|STANDARD_ERROR_OF_MEAN|2.0376||0.5555|TWO_SIDED|80.0|-1.44|3.8615|||Mixed Models Analysis|||Day 10: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||3.8615|-1.440|0.5555
72404931|NCT01675882|144317170|SUPERIORITY||Relative risk|0.47||||0.4048|TWO_SIDED|95.0|0.1|2.28|||Fisher Exact|||||2.28|0.10|0.4048
72491162|NCT00531752|144510566|SUPERIORITY_OR_OTHER||LS Mean Difference|3.1804|STANDARD_ERROR_OF_MEAN|2.1934||0.1533|TWO_SIDED|80.0|0.33169|6.0292|||Mixed Models Analysis|||Day 11: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||6.0292|0.33169|0.1533
72491163|NCT00531752|144510566|SUPERIORITY_OR_OTHER||LS Mean Difference|2.0511|STANDARD_ERROR_OF_MEAN|2.2662||0.3697|TWO_SIDED|80.0|-0.8912|4.9934|||Mixed Models Analysis|||Day 11: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||4.9934|-0.8912|0.3697
72491164|NCT00531752|144510566|SUPERIORITY_OR_OTHER||LS Mean Difference|1.764|STANDARD_ERROR_OF_MEAN|2.3939||0.4652|TWO_SIDED|80.0|-1.352|4.8801|||Mixed Models Analysis|||Day 12: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||4.8801|-1.352|0.4652
72491165|NCT00531752|144510566|SUPERIORITY_OR_OTHER||LS Mean Difference|0.4377|STANDARD_ERROR_OF_MEAN|2.5148||0.8626|TWO_SIDED|80.0|-2.83|3.7058|||Mixed Models Analysis|||Day 12: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||3.7058|-2.830|0.8626
72491166|NCT00531752|144510566|SUPERIORITY_OR_OTHER||LS Mean Difference|3.7114|STANDARD_ERROR_OF_MEAN|1.6168||0.0261|TWO_SIDED|80.0|1.6105|5.8122|||Mixed Models Analysis|||Day 13: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||5.8122|1.6105|0.0261
72491167|NCT00531752|144510566|SUPERIORITY_OR_OTHER||LS Mean Difference|2.2644|STANDARD_ERROR_OF_MEAN|1.7026||0.1895|TWO_SIDED|80.0|0.0533|4.4756|||Mixed Models Analysis|||Day 13: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||4.4756|0.05330|0.1895
72491168|NCT00531752|144510566|SUPERIORITY_OR_OTHER||LS Mean Difference|2.1151|STANDARD_ERROR_OF_MEAN|3.0732||0.4994|TWO_SIDED|80.0|-1.961|6.1913|||Mixed Models Analysis|||Day 14: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||6.1913|-1.961|0.4994
72491169|NCT00531752|144510566|SUPERIORITY_OR_OTHER||LS Mean Difference|3.5616|STANDARD_ERROR_OF_MEAN|3.3113||0.2945|TWO_SIDED|80.0|-0.8226|7.9458|||Mixed Models Analysis|||Day 14: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||7.9458|-0.8226|0.2945
72404932|NCT01675882|144317170|SUPERIORITY||Relative risk|1.75||||0.4705|TWO_SIDED|95.0|0.62|4.95|||Fisher Exact|||||4.95|0.62|0.4705
72404933|NCT01675882|144317171|SUPERIORITY||Relative risk|0.5||||0.5921|TWO_SIDED|95.0|0.13|1.9|||Fisher Exact|||||1.90|0.13|0.5921
72404934|NCT01675882|144317171|SUPERIORITY||Relative risk|1.43||||0.326|TWO_SIDED|95.0|0.71|2.88|||Fisher Exact|||||2.88|0.71|0.3260
72404935|NCT01675882|144317171|SUPERIORITY||Relative risk|1.05||||1|TWO_SIDED|95.0|0.46|2.38|||Fisher Exact|||||2.38|0.46|1.0000
72491170|NCT00531752|144510566|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.7306|STANDARD_ERROR_OF_MEAN|2.9257||0.8056|TWO_SIDED|80.0|-4.622|3.1613|||Mixed Models Analysis|||Day 21: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||3.1613|-4.622|0.8056
72491171|NCT00531752|144510566|SUPERIORITY_OR_OTHER||LS Mean Difference|3.3672|STANDARD_ERROR_OF_MEAN|3.8657||0.3922|TWO_SIDED|80.0|-1.725|8.4592|||Mixed Models Analysis|||Day 21: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||8.4592|-1.725|0.3922
72491172|NCT00531752|144510567|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.5069|STANDARD_ERROR_OF_MEAN|0.8744||0.0913|TWO_SIDED|80.0|-2.643|-0.3705|||Mixed Models Analysis|||Week 3: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||-0.3705|-2.643|0.0913
72491173|NCT00531752|144510567|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2078|STANDARD_ERROR_OF_MEAN|0.9165||0.8216|TWO_SIDED|80.0|-1.399|0.98326|||Mixed Models Analysis|||Day 3: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||0.98326|-1.399|0.8216
72569205|NCT01000493|144669690|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.81||||0.4292|TWO_SIDED|95.0|-4.22|9.84||The MMRM analysis model included treatment, week, Baseline total CAPS score, and the treatment by week and Baseline by week interaction terms. Week was used as the repeated effect in the model.|MMRM analysis||Comparison between placebo and orvepitant 60 mg once daily at Week 4.|||9.84|-4.22|0.4292
72491174|NCT00531752|144510568|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4181|STANDARD_ERROR_OF_MEAN|0.6887||0.5466|TWO_SIDED|80.0|-1.313|0.47668|||Mixed Models Analysis|||Week 3: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||0.47668|-1.313|0.5466
72491175|NCT00531752|144510568|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.02518|STANDARD_ERROR_OF_MEAN|0.6772||0.9705|TWO_SIDED|80.0|-0.9035|0.85312|||Mixed Models Analysis|||Week 3: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||0.85312|-0.9035|0.9705
72491176|NCT00531752|144510569|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.09953|STANDARD_ERROR_OF_MEAN|0.3001||0.7415|TWO_SIDED|80.0|-0.4892|0.29012|||Mixed Models Analysis|||Week 3 (CQoL): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||0.29012|-0.4892|0.7415
72491177|NCT00531752|144510569|SUPERIORITY_OR_OTHER||LS Mean Difference|0.04804|STANDARD_ERROR_OF_MEAN|0.3227||0.8822|TWO_SIDED|80.0|-0.3703|0.4664|||Mixed Models Analysis|||Week 3 (CQoL): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||0.46640|-0.3703|0.8822
72491178|NCT00531752|144510569|SUPERIORITY_OR_OTHER||LS Mean Difference|0.125|STANDARD_ERROR_OF_MEAN|0.1302||0.3414|TWO_SIDED|80.0|-0.0439|0.29385|||Mixed Models Analysis|||Week 3 (GLI): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||0.29385|-0.0439|0.3414
72491179|NCT00531752|144510569|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1044|STANDARD_ERROR_OF_MEAN|0.1418||0.4642|TWO_SIDED|80.0|-0.0793|0.28814|||Mixed Models Analysis|||Week 3 (GLI): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||0.28814|-0.0793|0.4642
72491180|NCT00531752|144510569|SUPERIORITY_OR_OTHER||LS Mean Difference|0.06109|STANDARD_ERROR_OF_MEAN|0.09093||0.5049|TWO_SIDED|80.0|-0.0571|0.17926|||Mixed Models Analysis|||Week 3 (RTI): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||0.17926|-0.0571|0.5049
72491181|NCT00531752|144510569|SUPERIORITY_OR_OTHER||LS Mean Difference|0.07917|STANDARD_ERROR_OF_MEAN|0.1002||0.4332|TWO_SIDED|80.0|-0.051|0.2093|||Mixed Models Analysis|||Week 3 (RTI): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||0.20930|-0.0510|0.4332
72491182|NCT00531752|144510569|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2453|STANDARD_ERROR_OF_MEAN|0.1753||0.1678|TWO_SIDED|80.0|-0.473|-0.0177|||Mixed Models Analysis|||Week 3 (More GD than BD): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||-0.0177|-0.4730|0.1678
72569206|NCT01000493|144669690|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.64||||0.3702|TWO_SIDED|95.0|-14.9|5.62||The MMRM analysis model included treatment, week, Baseline total CAPS score, and the treatment by week and Baseline by week interaction terms. Week was used as the repeated effect in the model.|MMRM analysis||Comparison between placebo and orvepitant 60 mg once daily at Week 8.|||5.62|-14.9|0.3702
72569207|NCT01000493|144669691|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.49||||0.5719|TWO_SIDED|95.0|0.04|5.82|||Logistic regression analysis||Odds ratios represent the odds of improvement, relative to place. Comparison between placebo and orvepitant 60 mg once daily at Week 4.|||5.82|0.04|0.5719
72569208|NCT01000493|144669691|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.18||||0.908||95.0|0.07|20.1|||Logistic regression analysis||Odds ratios represent the odds of improvement, relative to place. Comparison between placebo and orvepitant 60 mg once daily at Week 8.|||20.1|0.07|0.9080
72569209|NCT01000493|144669691|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.92||||0.9486|TWO_SIDED|95.0|0.07|12.5|||Logistic regression analysis||Odds ratios represent the odds of improvement, relative to place. Comparison between placebo and orvepitant 60 mg once daily at Week 12.|||12.5|0.07|0.9486
72624692|NCT01346592|144778963|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (H3N2 strain)|1.51|||||TWO_SIDED|95.0|1.26|1.82||||||No risk subjects||1.82|1.26|
72404936|NCT01675882|144317172|SUPERIORITY||Difference in LS mean|70.2||||0.0607|TWO_SIDED|95.0|-2.41|193.69||P-value was based on type III sum of squares from analysis of covariance (ANCOVA) model on log transformed values for peanut protein eliciting dose at Month 12, including treatment group, baseline eliciting dose, age-strata and country as covariates.|ANCOVA|||The least squares (LS) mean for any given treatment group is the estimated mean peanut protein eliciting dose for a participant in that treatment group with the mean value for all baseline covariates in the analysis set.||193.69|-2.41|0.0607
72404937|NCT01675882|144317172|SUPERIORITY||Difference in LS mean|97.5||||0.015|TWO_SIDED|95.0|14.45|237.82||P-value was based on type III sum of squares from an ANCOVA model on log transformed values for the peanut protein eliciting dose at Month 12, including treatment group, baseline eliciting dose, age-strata and country as covariates.|ANCOVA|||The LS mean for any given treatment group is the estimated mean peanut protein eliciting dose for a participant in that treatment group with the mean value for all baseline covariates in the analysis set.||237.82|14.45|0.0150
72404938|NCT01675882|144317172|SUPERIORITY||Difference in LS mean|242.2|||<|0.0001|TWO_SIDED|95.0|100.03|482.65||P-value was based on type III sum of squares from an ANCOVA model on log transformed values for the peanut protein eliciting dose at Month 12, including treatment group, baseline eliciting dose, age-strata and country as covariates.|ANCOVA|||The LS mean for any given treatment group is the estimated mean peanut protein eliciting dose for a participant in that treatment group with the mean value for all baseline covariates in the analysis set.||482.65|100.03|<0.0001
72624693|NCT01346592|144778963|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (B strain)|1.9|||||TWO_SIDED|95.0|1.52|2.38||||||No risk subjects||2.38|1.52|
72491183|NCT00531752|144510569|SUPERIORITY_OR_OTHER||LS Mean Difference|0.07717|STANDARD_ERROR_OF_MEAN|0.1925||0.6901|TWO_SIDED|80.0|-0.1726|0.32695|||Mixed Models Analysis|||Week 3 (More GD than BD): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||0.32695|-0.1726|0.6901
72491184|NCT00531752|144510569|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1702|STANDARD_ERROR_OF_MEAN|1.354||0.9005|TWO_SIDED|80.0|-1.587|1.9274|||Mixed Models Analysis|||Week 3 (Living with ADHD): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||1.9274|-1.587|0.9005
72491185|NCT00531752|144510569|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.4317|STANDARD_ERROR_OF_MEAN|1.4667||0.333|TWO_SIDED|80.0|-3.333|0.46937|||Mixed Models Analysis|||Week 3 (Living with ADHD): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||0.46937|-3.333|0.3330
72491186|NCT00531752|144510569|SUPERIORITY_OR_OTHER||LS Mean Difference|0.6537|STANDARD_ERROR_OF_MEAN|2.0857||0.7551|TWO_SIDED|80.0|-2.051|3.3584|||Mixed Models Analysis|||Week 3 (General well-being): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||3.3584|-2.051|0.7551
72491187|NCT00531752|144510569|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.8639|STANDARD_ERROR_OF_MEAN|2.2354||0.0334|TWO_SIDED|80.0|-7.759|-1.968|||Mixed Models Analysis|||Week 3 (General well-being): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||-1.968|-7.759|0.0334
72624694|NCT01346592|144778963|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (H1N1 strain)|1.76|||||TWO_SIDED|95.0|0.57|5.4||||||At risk subjects||5.4|0.57|
72624695|NCT01346592|144778963|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (H3N2 strain)|1.78|||||TWO_SIDED|95.0|1.09|2.89||||||At risk subjects||2.89|1.09|
72624696|NCT01346592|144778963|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (B strain)|1.82|||||TWO_SIDED|95.0|0.73|4.54||||||At risk subjects||4.54|0.73|
72624697|NCT01346592|144778963|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (H1N1 strain)|2.4|||||TWO_SIDED|95.0|1.89|3.05||||||No risk subjects||3.05|1.89|
72624698|NCT01346592|144778963|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (H3N2 strain)|1.54|||||TWO_SIDED|95.0|1.29|1.85||||||No risk subjects.||1.85|1.29|
72624699|NCT01346592|144778963|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (B strain)|1.7|||||TWO_SIDED|95.0|1.36|2.11||||||No risk subjects||2.11|1.36|
72624700|NCT01346592|144778963|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (H1N1 strain)|2.12|||||TWO_SIDED|95.0|0.58|7.71||||||At risk subjects.||7.71|0.58|
72624701|NCT01346592|144778963|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (H3N2 strain)|2.81|||||TWO_SIDED|95.0|1.61|4.89||||||At risk subjects||4.89|1.61|
72624702|NCT01346592|144778963|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (B strain)|1.17|||||TWO_SIDED|95.0|0.37|3.67||||||At risk subjects||3.67|0.37|
72624703|NCT01346592|144778964|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%|Group difference (H1N1 strain)|9.0|||||TWO_SIDED|95.0|5.4|12.0||||||No risk subjects.||12|5.4|
72624704|NCT01346592|144778964|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (H3N2 strain)|4.0|||||TWO_SIDED|95.0|1.8|6.6||||||No risk subjects.||6.6|1.8|
72624705|NCT01346592|144778964|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (B strain)|12.0|||||TWO_SIDED|95.0|9.2|14.8||||||No risk subjects.||14.8|9.2|
72624706|NCT01346592|144778964|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (H1N1 strain)|-1.0|||||TWO_SIDED|95.0|-24.0|18.7||||||At risk subjects.||18.7|-24|
72624707|NCT01346592|144778964|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (H3N2 strain)|1.0|||||TWO_SIDED|95.0|-21.2|18.9||||||At risk subjects.||18.9|-21.2|
72491188|NCT00531752|144510569|SUPERIORITY_OR_OTHER||LS Mean Difference|1.6389|STANDARD_ERROR_OF_MEAN|3.6119||0.6519|TWO_SIDED|80.0|-3.05|6.3281|||Mixed Models Analysis|||Week 3 (PDF): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||6.3281|-3.050|0.6519
72491189|NCT00531752|144510569|SUPERIORITY_OR_OTHER||LS Mean Difference|1.2007|STANDARD_ERROR_OF_MEAN|3.9647||0.7631|TWO_SIDED|80.0|-3.941|6.3423|||Mixed Models Analysis|||Week 3 (PDF): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||6.3423|-3.941|0.7631
72491190|NCT00531752|144510569|SUPERIORITY_OR_OTHER||LS Mean Difference|2.9211|STANDARD_ERROR_OF_MEAN|2.8206||0.3034|TWO_SIDED|80.0|-0.7227|6.5648|||Mixed Models Analysis|||Week 3 (R/C): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||6.5648|-0.7227|0.3034
72491191|NCT00531752|144510569|SUPERIORITY_OR_OTHER||LS Mean Difference|-5.0968|STANDARD_ERROR_OF_MEAN|3.0022||0.0933|TWO_SIDED|80.0|-8.975|-1.218|||Mixed Models Analysis|||Week 3 (R/C): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||-1.218|-8.975|0.0933
72491192|NCT00531752|144510569|SUPERIORITY_OR_OTHER||LS Mean Difference|-5.0675|STANDARD_ERROR_OF_MEAN|2.9778||0.0949|TWO_SIDED|80.0|-8.934|-1.201|||Mixed Models Analysis|||Week 3 (IS-B/C): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||-1.201|-8.934|0.0949
72517211|NCT02528253|144564410|SUPERIORITY||LS Mean Difference|0.74|STANDARD_ERROR_OF_MEAN|1.64||0.6508|TWO_SIDED|95.0|-2.49|3.98|||ANCOVA|||Change at Week 16: Percent Work Time Missed: ANCOVA model included treatment as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.||3.98|-2.49|0.6508
72569210|NCT01000493|144669693|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.67||||0.5426|TWO_SIDED|95.0|-1.51|2.85||The MMRM analysis model included treatment, week, Baseline CAPS A/N subscore and the treatment by week and Baseline by week interaction terms. Week was used as the repeated effect in the model.|MMRM analysis||Comparison between placebo and orvepitant 60 mg once daily at Week 1.|||2.85|-1.51|0.5426
72624708|NCT01346592|144778964|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (B strain)|14.0|||||TWO_SIDED|95.0|-1.6|29.5||||||At risk subjects.||29.5|-1.6|
72624709|NCT01346592|144778964|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (H1N1 strain)|14.0|||||TWO_SIDED|95.0|10.7|17.7||||||No risk subjects.||17.7|10.7|
72491193|NCT00531752|144510569|SUPERIORITY_OR_OTHER||LS Mean Difference|-7.3274|STANDARD_ERROR_OF_MEAN|3.2552||0.0283|TWO_SIDED|80.0|-11.55|-3.106|||Mixed Models Analysis|||Week 3 (IS-B/C): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||-3.106|-11.55|0.0283
72517212|NCT02528253|144564410|SUPERIORITY||LS Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|1.66||0.9629|TWO_SIDED|95.0|-3.33|3.18|||ANCOVA|||Change at Week 16: Percent Work Time Missed: ANCOVA model included treatment as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.||3.18|-3.33|0.9629
72569211|NCT01000493|144669693|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.51||||0.7552|TWO_SIDED|95.0|-2.73|3.75||The MMRM analysis model included treatment, week, Baseline CAPS A/N subscore and the treatment by week and Baseline by week interaction terms. Week was used as the repeated effect in the model.|MMRM analysis||Comparison between placebo and orvepitant 60 mg once daily at Week 4.|||3.75|-2.73|0.7552
72624710|NCT01346592|144778964|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (H3N2 strain)|7.0|||||TWO_SIDED|95.0|4.6|9.8||||||No risk subjects.||9.8|4.6|
72624711|NCT01346592|144778964|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (B strain)|13.0|||||TWO_SIDED|95.0|10.7|16.4||||||No risk subjects||16.4|10.7|
72624712|NCT01346592|144778964|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (H1N1 strain)|-3.0|||||TWO_SIDED|95.0|-26.1|19.2||||||At risk subjects.||19.2|-26.1|
72624713|NCT01346592|144778964|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (H3N2 strain)|6.0|||||TWO_SIDED|95.0|-17.5|27.3||||||At risk subjects.||27.3|-17.5|
72624714|NCT01346592|144778964|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (B strain)|12.0|||||TWO_SIDED|95.0|-4.4|29.2||||||At risk subjects.||29.2|-4.4|
72624715|NCT01346592|144778964|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (H1N1 strain)|11.0|||||TWO_SIDED|95.0|7.2|14.5||||||No risk subjects.||14.5|7.2|
72624716|NCT01346592|144778964|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (H3N2 strain)|5.0|||||TWO_SIDED|95.0|2.6|7.5||||||No risk subjects.||7.5|2.6|
72624717|NCT01346592|144778964|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (B strain)|13.0|||||TWO_SIDED|95.0|9.5|15.8||||||No risk subjects.||15.8|9.5|
72624718|NCT01346592|144778964|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (H1N1 strain)|5.0|||||TWO_SIDED|95.0|-24.7|26.3||||||At risk subjects.||26.3|-24.7|
72624719|NCT01346592|144778964|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (H3N2 strain)|5.0|||||TWO_SIDED|95.0|-26.9|30.3||||||At risk subjects.||30.3|-26.9|
72624720|NCT01346592|144778964|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (B strain)|9.0|||||TWO_SIDED|95.0|-16.9|27.1||||||At risk subjects.||27.1|-16.9|
72491194|NCT00531752|144510569|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.1505|STANDARD_ERROR_OF_MEAN|1.5974||0.1852|TWO_SIDED|80.0|-4.229|-0.0719|||Mixed Models Analysis|||Week 3 (IS-I): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||-0.0719|-4.229|0.1852
72624721|NCT01346592|144778964|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (H1N1 strain)|16.0|||||TWO_SIDED|95.0|12.4|20.2||||||No risk subjects.||20.2|12.4|
72624722|NCT01346592|144778964|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (H3N2 strain)|8.0|||||TWO_SIDED|95.0|5.1|10.5||||||No risk subjects||10.5|5.1|
72624723|NCT01346592|144778964|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (B strain)|15.0|||||TWO_SIDED|95.0|12.0|18.6||||||No risk subjects||18.6|12|
72491195|NCT00531752|144510569|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.5178|STANDARD_ERROR_OF_MEAN|1.7732||0.1623|TWO_SIDED|80.0|-4.823|-0.2127|||Mixed Models Analysis|||Week 3 (IS-I): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||-0.2127|-4.823|0.1623
72491196|NCT00531752|144510570|SUPERIORITY_OR_OTHER||LS Mean Difference|-11.5791|STANDARD_ERROR_OF_MEAN|18.0449||0.5241|TWO_SIDED|80.0|-35.02|11.86|||Mixed Models Analysis|||Week 3 (Life productivity): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||11.860|-35.02|0.5241
72491197|NCT00531752|144510570|SUPERIORITY_OR_OTHER||LS Mean Difference|-20.3367|STANDARD_ERROR_OF_MEAN|19.6995||0.3065|TWO_SIDED|80.0|-45.89|5.2183|||Mixed Models Analysis|||Week 3 (Life productivity): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||5.2183|-45.89|0.3065
72491198|NCT00531752|144510570|SUPERIORITY_OR_OTHER||LS Mean Difference|-11.7878|STANDARD_ERROR_OF_MEAN|13.4438||0.3831|TWO_SIDED|80.0|-29.15|5.5793|||Mixed Models Analysis|||Week 3 (Psychological health): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||5.5793|-29.15|0.3831
72491199|NCT00531752|144510570|SUPERIORITY_OR_OTHER||LS Mean Difference|-13.1401|STANDARD_ERROR_OF_MEAN|14.4478||0.3657|TWO_SIDED|80.0|-31.8|5.5241|||Mixed Models Analysis|||Week 3 (Psychological health): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||5.5241|-31.80|0.3657
72491200|NCT00531752|144510570|SUPERIORITY_OR_OTHER||LS Mean Difference|2.666|STANDARD_ERROR_OF_MEAN|11.5818||0.8188|TWO_SIDED|80.0|-12.36|17.69|||Mixed Models Analysis|||Week 3 (Life outlook): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||17.690|-12.36|0.8188
72517213|NCT02528253|144564410|SUPERIORITY||LS Mean Difference|0.6|STANDARD_ERROR_OF_MEAN|1.57||0.7007|TWO_SIDED|95.0|-2.48|3.69|||ANCOVA|||Change at Week 16: Percent Work Time Missed: ANCOVA model included treatment as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.||3.69|-2.48|0.7007
72517214|NCT02528253|144564410|SUPERIORITY||LS Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|1.58||0.8902|TWO_SIDED|95.0|-3.32|2.88|||ANCOVA|||Change at Week 16: Percent Work Time Missed: ANCOVA model included treatment as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.||2.88|-3.32|0.8902
72517215|NCT02528253|144564410|SUPERIORITY||LS Mean Difference|-0.87|STANDARD_ERROR_OF_MEAN|1.53||0.5698|TWO_SIDED|95.0|-3.89|2.15|||ANCOVA|||Change at Week 56: Percent Work Time Missed: ANCOVA model included treatment as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.||2.15|-3.89|0.5698
72517216|NCT02528253|144564410|SUPERIORITY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|1.53||0.8464|TWO_SIDED|95.0|-3.32|2.72|||ANCOVA|||Change at Week 56: Percent Work Time Missed: ANCOVA model included treatment as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.||2.72|-3.32|0.8464
72517217|NCT02528253|144564410|SUPERIORITY||LS Mean Difference|-4.03|STANDARD_ERROR_OF_MEAN|2.39||0.0919|TWO_SIDED|95.0|-8.72|0.66|||ANCOVA|||Change at Week 16: Percent Impairment While Working: ANCOVA model included treatment as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.||0.66|-8.72|0.0919
72517218|NCT02528253|144564410|SUPERIORITY||LS Mean Difference|-4.76|STANDARD_ERROR_OF_MEAN|2.4||0.0477|TWO_SIDED|95.0|-9.47|-0.05|||ANCOVA|||Change at Week 16: Percent Impairment While Working: ANCOVA model included treatment as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.||-0.05|-9.47|0.0477
72517219|NCT02528253|144564410|SUPERIORITY||LS Mean Difference|-1.65|STANDARD_ERROR_OF_MEAN|2.3||0.4735|TWO_SIDED|95.0|-6.17|2.87|||ANCOVA|||Change at Week 16: Percent Impairment While Working: ANCOVA model included treatment as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.||2.87|-6.17|0.4735
72517220|NCT02528253|144564410|SUPERIORITY||LS Mean Difference|-2.38|STANDARD_ERROR_OF_MEAN|2.26||0.2935|TWO_SIDED|95.0|-6.82|2.06|||ANCOVA|||Change at Week 16: Percent Impairment While Working: ANCOVA model included treatment as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.||2.06|-6.82|0.2935
72517221|NCT02528253|144564410|SUPERIORITY||LS Mean Difference|-3.11|STANDARD_ERROR_OF_MEAN|2.27||0.1714|TWO_SIDED|95.0|-7.56|1.35|||ANCOVA|||Change at Week 16: Percent Impairment While Working: ANCOVA model included treatment as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.||1.35|-7.56|0.1714
72517222|NCT02528253|144564410|SUPERIORITY||LS Mean Difference|-0.87|STANDARD_ERROR_OF_MEAN|2.75||0.7521|TWO_SIDED|95.0|-6.3|4.56|||ANCOVA|||Change at Week 56: Percent Impairment While Working: ANCOVA model included treatment as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.||4.56|-6.30|0.7521
72517223|NCT02528253|144564410|SUPERIORITY||LS Mean Difference|-2.81|STANDARD_ERROR_OF_MEAN|2.75||0.3078|TWO_SIDED|95.0|-8.24|2.61|||ANCOVA|||Change at Week 56: Percent Impairment While Working: ANCOVA model included treatment as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.||2.61|-8.24|0.3078
72517224|NCT02528253|144564410|SUPERIORITY||LS Mean Difference|-3.95|STANDARD_ERROR_OF_MEAN|2.46||0.109|TWO_SIDED|95.0|-8.78|0.88|||ANCOVA|||Change at Week 16: Percent Overall Work Impairment: ANCOVA model included treatment as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.||0.88|-8.78|0.1090
72517225|NCT02528253|144564410|SUPERIORITY||LS Mean Difference|-5.41|STANDARD_ERROR_OF_MEAN|2.47||0.0289|TWO_SIDED|95.0|-10.27|-0.56|||ANCOVA|||Change at Week 16: Percent Overall Work Impairment: ANCOVA model included treatment as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.||-0.56|-10.27|0.0289
72517226|NCT02528253|144564410|SUPERIORITY||LS Mean Difference|-1.75|STANDARD_ERROR_OF_MEAN|2.37||0.4613|TWO_SIDED|95.0|-6.41|2.91|||ANCOVA|||Change at Week 16: Percent Overall Work Impairment: ANCOVA model included treatment as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.||2.91|-6.41|0.4613
72517227|NCT02528253|144564410|SUPERIORITY||LS Mean Difference|-2.2|STANDARD_ERROR_OF_MEAN|2.33||0.346|TWO_SIDED|95.0|-6.78|2.38|||ANCOVA|||Change at Week 16: Percent Overall Work Impairment: ANCOVA model included treatment as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.||2.38|-6.78|0.3460
72517228|NCT02528253|144564410|SUPERIORITY||LS Mean Difference|-3.66|STANDARD_ERROR_OF_MEAN|2.34||0.1179|TWO_SIDED|95.0|-8.26|0.93|||ANCOVA|||Change at Week 16: Percent Overall Work Impairment: ANCOVA model included treatment as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.||0.93|-8.26|0.1179
72517229|NCT02528253|144564410|SUPERIORITY||LS Mean Difference|-1.93|STANDARD_ERROR_OF_MEAN|2.97||0.5151|TWO_SIDED|95.0|-7.78|3.92|||ANCOVA|||Change at Week 56: Percent Overall Work Impairment: ANCOVA model included treatment as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.||3.92|-7.78|0.5151
72517230|NCT02528253|144564410|SUPERIORITY||LS Mean Difference|-3.38|STANDARD_ERROR_OF_MEAN|2.96||0.255|TWO_SIDED|95.0|-9.22|2.46|||ANCOVA|||Change at Week 56: Percent Overall Work Impairment: ANCOVA model included treatment as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.||2.46|-9.22|0.2550
72517231|NCT02528253|144564410|SUPERIORITY||LS Mean Difference|-4.18|STANDARD_ERROR_OF_MEAN|1.73||0.0157|TWO_SIDED|95.0|-7.57|-0.79|||ANCOVA|||Change at Week 16: Percent Activity Impairment: ANCOVA model included treatment as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.||-0.79|-7.57|0.0157
72517232|NCT02528253|144564410|SUPERIORITY||LS Mean Difference|-4.18|STANDARD_ERROR_OF_MEAN|1.73||0.0159|TWO_SIDED|95.0|-7.57|-0.78|||ANCOVA|||Change at Week 16: Percent Activity Impairment: ANCOVA model included treatment as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.||-0.78|-7.57|0.0159
72569212|NCT01000493|144669693|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.22||||0.3827|TWO_SIDED|95.0|-7.27|2.83||The MMRM analysis model included treatment, week, Baseline CAPS A/N subscore and the treatment by week and Baseline by week interaction terms. Week was used as the repeated effect in the model.|MMRM analysis||Comparison between placebo and orvepitant 60 mg once daily at Week 8.|||2.83|-7.27|0.3827
72569213|NCT01000493|144669693|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.98||||0.4915|TWO_SIDED|95.0|-7.71|3.75||The MMRM analysis model included treatment, week, Baseline CAPS A/N subscore and the treatment by week and Baseline by week interaction terms. Week was used as the repeated effect in the model.|MMRM analysis||Comparison between placebo and orvepitant 60 mg once daily at Week 12.|||3.75|-7.71|0.4915
72569214|NCT01000493|144669694|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.09||||0.919|TWO_SIDED|95.0|-1.93|1.74||The MMRM analysis model included treatment, week, Baseline CAPS hyperarousal subscore and the treatment by week and Baseline by week interaction terms. Week was used as the repeated effect in the model.|MMRM analysis||Comparison between placebo and orvepitant 60 mg once daily at Week 1.|||1.74|-1.93|0.9190
72569215|NCT01000493|144669694|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.32||||0.3326|TWO_SIDED|95.0|-1.37|4.0||The MMRM analysis model included treatment, week, Baseline CAPS hyperarousal subscore and the treatment by week and Baseline by week interaction terms. Week was used as the repeated effect in the model.|MMRM analysis||Comparison between placebo and orvepitant 60 mg once daily at Week 4.|||4.00|-1.37|0.3326
72624724|NCT01346592|144778964|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (H1N1 strain)|2.0|||||TWO_SIDED|95.0|-27.1|25.5||||||At risk subjects||25.5|-27.1|
72624725|NCT01346592|144778964|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (H3N2 strain)|10.0|||||TWO_SIDED|95.0|-23.5|37.2||||||At risk subjects||37.2|-23.5|
72624726|NCT01346592|144778964|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (B strain)|16.0|||||TWO_SIDED|95.0|-10.7|38.0||||||At risk subjects.||38|-10.7|
72624727|NCT01346592|144778964|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (H1N1 strain)|2.0|||||TWO_SIDED|95.0|-4.2|10.4||||||No risk subjects.||10.4|-4.2|
72569216|NCT01000493|144669694|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.07||||0.9712|TWO_SIDED|95.0|-3.91|3.77||The MMRM analysis model included treatment, week, Baseline CAPS hyperarousal subscore and the treatment by week and Baseline by week interaction terms. Week was used as the repeated effect in the model.|MMRM analysis||Comparison between placebo and orvepitant 60 mg once daily at Week 8.|||3.77|-3.91|0.9712
72569217|NCT01000493|144669694|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.92||||0.6711|TWO_SIDED|95.0|-5.22|3.39||The MMRM analysis model included treatment, week, Baseline CAPS hyperarousal subscore and the treatment by week and Baseline by week interaction terms. Week was used as the repeated effect in the model.|MMRM analysis||Comparison between placebo and orvepitant 60 mg once daily at Week 12.|||3.39|-5.22|0.6711
72491201|NCT00531752|144510570|SUPERIORITY_OR_OTHER||LS Mean Difference|24.1011|STANDARD_ERROR_OF_MEAN|12.405||0.0566|TWO_SIDED|80.0|8.0305|40.172|||Mixed Models Analysis|||Week 3 (Life outlook): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||40.172|8.0305|0.0566
72569218|NCT01000493|144669695|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.57||||0.5532|TWO_SIDED|95.0|0.36|6.92||The analysis method was logistic regression adjusted for Baseline total Clinical Global Impression-Severity of Illness scales (CGI-S) score.|Logistic regression analysis||Odds ratios represent the odds of improvement, relative to placebo. Comparison between placebo and orvepitant 60 mg once daily at Week 1.|||6.92|0.36|0.5532
72569219|NCT01000493|144669695|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.46||||0.4508|TWO_SIDED|95.0|0.54|3.93|||Logistic regression analysis||Odds ratios represent the odds of improvement, relative to placebo. The analysis method was logistic regression adjusted for Baseline total CGI-S score. Comparison between placebo and orvepitant 60 mg once daily at Week 2.|||3.93|0.54|0.4508
72569220|NCT01000493|144669695|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.05||||0.9234|TWO_SIDED|95.0|0.42|2.62|||Logistic regression analysis||Odds ratios represent the odds of improvement, relative to placebo. The analysis method was logistic regression adjusted for Baseline total CGI-S score. Comparison between placebo and orvepitant 60 mg once daily at Week 4.|||2.62|0.42|0.9234
72569221|NCT01000493|144669695|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.48||||0.0662|TWO_SIDED|95.0|0.94|6.53|||Logistic regression analysis||Odds ratios represent the odds of improvement, relative to placebo. The analysis method was logistic regression adjusted for Baseline total CGI-S score. Comparison between placebo and orvepitant 60 mg once daily at Week 1|||6.53|0.94|0.0662
72569222|NCT01000493|144669695|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.83||||0.2767|TWO_SIDED|95.0|0.61|5.48|||Logistic regression analysis||Odds ratios represent the odds of improvement, relative to placebo. The analysis method was logistic regression adjusted for Baseline total CGI-S score. Comparison between placebo and orvepitant 60 mg once daily at Week 8.|||5.48|0.61|0.2767
72569223|NCT01000493|144669695|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.17||||0.0588|TWO_SIDED|95.0|0.96|10.5|||Logistic regression analysis||Odds ratios represent the odds of improvement, relative to placebo. The analysis method was logistic regression adjusted for Baseline total CGI-S score. Comparison between placebo and orvepitant 60 mg once daily at Week 10.|||10.5|0.96|0.0588
72491202|NCT00531752|144510570|SUPERIORITY_OR_OTHER||LS Mean Difference|0.7559|STANDARD_ERROR_OF_MEAN|8.7164||0.9312|TWO_SIDED|80.0|-10.55|12.057|||Mixed Models Analysis|||Week 3 (Relationships): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||12.057|-10.55|0.9312
72491203|NCT00531752|144510570|SUPERIORITY_OR_OTHER||LS Mean Difference|6.1138|STANDARD_ERROR_OF_MEAN|9.4361||0.5194|TWO_SIDED|80.0|-6.108|18.336|||Mixed Models Analysis|||Week 3 (Relationships): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||18.336|-6.108|0.5194
72491204|NCT00531752|144510571|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3255|STANDARD_ERROR_OF_MEAN|0.332||0.332|TWO_SIDED|80.0|-0.7573|0.10622|||Mixed Models Analysis|||Week 3 (Work/school): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||0.10622|-0.7573|0.3320
72491205|NCT00531752|144510571|SUPERIORITY_OR_OTHER||LS Mean Difference|0.4255|STANDARD_ERROR_OF_MEAN|0.3871||0.2767|TWO_SIDED|80.0|-0.0769|0.92804|||Mixed Models Analysis|||Week 3 (Work/school): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||0.92804|-0.0769|0.2767
72491206|NCT00531752|144510571|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3661|STANDARD_ERROR_OF_MEAN|0.4028||0.3675|TWO_SIDED|80.0|-0.8887|0.1566|||Mixed Models Analysis|||Week 3 (Social life): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||0.15660|-0.8887|0.3675
72491207|NCT00531752|144510571|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1033|STANDARD_ERROR_OF_MEAN|0.4372||0.8141|TWO_SIDED|80.0|-0.67|0.46345|||Mixed Models Analysis|||Week 3 (Social life): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||0.46345|-0.6700|0.8141
72569224|NCT01000493|144669695|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.33||||0.1032|TWO_SIDED|95.0|0.78|14.1|||Logistic regression analysis||Odds ratios represent the odds of improvement, relative to placebo. The analysis method was logistic regression adjusted for Baseline total CGI-S score. Comparison between placebo and orvepitant 60 mg once daily at Week 12.|||14.1|0.78|0.1032
72569225|NCT01000493|144669696|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.12||||0.1743|TWO_SIDED|95.0|-0.29|0.05||The MMRM analysis model included treatment, week, baseline CGI-S score, and the treatment by week and baseline by week interaction terms. Week was used as the repeated effect in the model.|MMRM analysis||Comparison between placebo and orvepitant 60 mg once daily at Week 1.|||0.05|-0.29|0.1743
72569226|NCT01000493|144669696|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.2||||0.1181|TWO_SIDED|95.0|-0.46|0.05||The MMRM analysis model included treatment, week, baseline CGI-S score, and the treatment by week and baseline by week interaction terms. Week was used as the repeated effect in the model.|MMRM analysis||Comparison between placebo and orvepitant 60 mg once daily at Week 2.|||0.05|-0.46|0.1181
72569227|NCT01000493|144669696|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.01||||0.9698|TWO_SIDED|95.0|-0.35|0.34||The MMRM analysis model included treatment, week, baseline CGI-S score, and the treatment by week and baseline by week interaction terms. Week was used as the repeated effect in the model.|MMRM analysis||Comparison between placebo and orvepitant 60 mg once daily at Week 4.|||0.34|-0.35|0.9698
72569228|NCT01000493|144669696|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.3||||0.1341|TWO_SIDED|95.0|-0.69|0.09||The MMRM analysis model included treatment, week, baseline CGI-S score, and the treatment by week and baseline by week interaction terms. Week was used as the repeated effect in the model.|MMRM analysis||Comparison between placebo and orvepitant 60 mg once daily at Week 6.|||0.09|-0.69|0.1341
72569229|NCT01000493|144669696|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.61||||0.0064|TWO_SIDED|95.0|-1.04|-0.18||The MMRM analysis model included treatment, week, baseline CGI-S score, and the treatment by week and baseline by week interaction terms. Week was used as the repeated effect in the model.|MMRM analysis||Comparison between placebo and orvepitant 60 mg once daily at Week 8.|||-0.18|-1.04|0.0064
72491208|NCT00531752|144510571|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1854|STANDARD_ERROR_OF_MEAN|0.3702||0.6186|TWO_SIDED|80.0|-0.6657|0.29495|||Mixed Models Analysis|||Week 3 (Family life/home): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||0.29495|-0.6657|0.6186
72491209|NCT00531752|144510571|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3623|STANDARD_ERROR_OF_MEAN|0.4028||0.372|TWO_SIDED|80.0|-0.1597|0.88432|||Mixed Models Analysis|||Week 3 (Family life/home): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||0.88432|-0.1597|0.3720
72491210|NCT00531752|144510572|SUPERIORITY_OR_OTHER||LS Mean Difference|25.0781|STANDARD_ERROR_OF_MEAN|5.0238|<|0.0001|TWO_SIDED|80.0|18.565|31.591|||Mixed Models Analysis|||Week 1 (Sleep disturbance): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||31.591|18.565|<0.0001
72491211|NCT00531752|144510572|SUPERIORITY_OR_OTHER||LS Mean Difference|15.6481|STANDARD_ERROR_OF_MEAN|5.3551||0.0049|TWO_SIDED|80.0|8.711|22.585|||Mixed Models Analysis|||Week 1 (Sleep disturbance): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||22.585|8.7110|0.0049
72491212|NCT00531752|144510572|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.627|STANDARD_ERROR_OF_MEAN|3.5248||0.3078|TWO_SIDED|80.0|-8.196|0.94237|||Mixed Models Analysis|||Week 1 (Snoring): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||0.94237|-8.196|0.3078
72491213|NCT00531752|144510572|SUPERIORITY_OR_OTHER||LS Mean Difference|7.1594|STANDARD_ERROR_OF_MEAN|3.8022||0.0644|TWO_SIDED|80.0|2.2344|12.084|||Mixed Models Analysis|||Week 1 (Snoring): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||12.084|2.2344|0.0644
72491214|NCT00531752|144510572|SUPERIORITY_OR_OTHER||LS Mean Difference|4.5601|STANDARD_ERROR_OF_MEAN|3.1318||0.1517|TWO_SIDED|80.0|0.49198|8.6281|||Mixed Models Analysis|||Week 1 (ASoB): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||8.6281|0.49198|0.1517
72491215|NCT00531752|144510572|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.7384|STANDARD_ERROR_OF_MEAN|3.3281||0.8252|TWO_SIDED|80.0|-5.056|3.5789|||Mixed Models Analysis|||Week 1 (ASoB): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||3.5789|-5.056|0.8252
72491216|NCT00531752|144510572|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.6228|STANDARD_ERROR_OF_MEAN|0.2203||0.0063|TWO_SIDED|80.0|-0.9082|-0.3375|||Mixed Models Analysis|||Week 1 (Sleep quantity): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||-0.3375|-0.9082|0.0063
72491217|NCT00531752|144510572|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2301|STANDARD_ERROR_OF_MEAN|0.2303||0.3217|TWO_SIDED|80.0|-0.5283|0.06822|||Mixed Models Analysis|||Week 1 (Sleep quantity): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||0.06822|-0.5283|0.3217
72491218|NCT00531752|144510572|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1291|STANDARD_ERROR_OF_MEAN|0.1065||0.2307|TWO_SIDED|80.0|-0.0091|0.26716|||Mixed Models Analysis|||Week 1 (Optimal sleep): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||0.26716|-0.0091|0.2307
72491219|NCT00531752|144510572|SUPERIORITY_OR_OTHER||LS Mean Difference|0.08114|STANDARD_ERROR_OF_MEAN|0.1087||0.4585|TWO_SIDED|80.0|-0.0598|0.22209|||Mixed Models Analysis|||Week 1 (Optimal sleep): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||0.22209|-0.0598|0.4585
72491220|NCT00531752|144510572|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.6629|STANDARD_ERROR_OF_MEAN|3.8642||0.3477|TWO_SIDED|80.0|-8.681|1.3549|||Mixed Models Analysis|||Week 1 (Sleep adequacy): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||1.3549|-8.681|0.3477
72517233|NCT02528253|144564410|SUPERIORITY||LS Mean Difference|-2.75|STANDARD_ERROR_OF_MEAN|1.62||0.0896|TWO_SIDED|95.0|-5.94|0.43|||ANCOVA|||Change at Week 16: Percent Activity Impairment: ANCOVA model included treatment as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.||0.43|-5.94|0.0896
72517234|NCT02528253|144564410|SUPERIORITY||LS Mean Difference|-1.42|STANDARD_ERROR_OF_MEAN|1.6||0.3749|TWO_SIDED|95.0|-4.57|1.72|||ANCOVA|||Change at Week 16: Percent Activity Impairment: ANCOVA model included treatment as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.||1.72|-4.57|0.3749
72517235|NCT02528253|144564410|SUPERIORITY||LS Mean Difference|-1.42|STANDARD_ERROR_OF_MEAN|1.59||0.3733|TWO_SIDED|95.0|-4.55|1.71|||ANCOVA|||Change at Week 16: Percent Activity Impairment: ANCOVA model included treatment as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.||1.71|-4.55|0.3733
72491221|NCT00531752|144510572|SUPERIORITY_OR_OTHER||LS Mean Difference|-5.8688|STANDARD_ERROR_OF_MEAN|4.0842||0.1565|TWO_SIDED|80.0|-11.17|-0.5693|||Mixed Models Analysis|||Week 1 (Sleep adequacy): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||-0.5693|-11.17|0.1565
72517236|NCT02528253|144564410|SUPERIORITY||LS Mean Difference|-0.53|STANDARD_ERROR_OF_MEAN|2.17||0.8056|TWO_SIDED|95.0|-4.8|3.73|||ANCOVA|||Change at Week 56: Percent Activity Impairment: ANCOVA model included treatment as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.||3.73|-4.80|0.8056
72517237|NCT02528253|144564410|SUPERIORITY||LS Mean Difference|-1.16|STANDARD_ERROR_OF_MEAN|2.08||0.5764|TWO_SIDED|95.0|-5.25|2.93|||ANCOVA|||Change at Week 56: Percent Activity Impairment: ANCOVA model included treatment as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.||2.93|-5.25|0.5764
72517238|NCT02528253|144564411|SUPERIORITY||Odds Ratio (OR)|0.93||||0.7366|TWO_SIDED|95.0|0.62|1.41|||Regression, Logistic|||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.41|0.62|0.7366
72624728|NCT01346592|144778964|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (H3N2 subjects)|4.0|||||TWO_SIDED|95.0|-1.2|11.9||||||No risk subjects.||11.9|-1.2|
72491222|NCT00531752|144510572|SUPERIORITY_OR_OTHER||LS Mean Difference|-6.4319|STANDARD_ERROR_OF_MEAN|3.9541||0.1088|TWO_SIDED|80.0|-11.55|-1.311|||Mixed Models Analysis|||Week 1 (Somnolence): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||-1.311|-11.55|0.1088
72491223|NCT00531752|144510572|SUPERIORITY_OR_OTHER||LS Mean Difference|0.7208|STANDARD_ERROR_OF_MEAN|4.1517||0.8627|TWO_SIDED|80.0|-4.654|6.0952|||Mixed Models Analysis|||Week 1 (Somnolence): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||6.0952|-4.654|0.8627
72517239|NCT02528253|144564411|SUPERIORITY||Odds Ratio (OR)|1.06||||0.771|TWO_SIDED|95.0|0.71|1.58|||Regression, Logistic|||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.58|0.71|0.7710
72517240|NCT02528253|144564412|SUPERIORITY|||||||0.4724|||||||Log Rank|||Missing data for the selected percentile(s) was due to the Kaplan-Meier estimate not reaching the level for discontinuation due to lack of efficacy.||||0.4724
72517241|NCT02528253|144564412|SUPERIORITY|||||||0.7142|||||||Log Rank|||Missing data for the selected percentile(s) was due to the Kaplan-Meier estimate not reaching the level for discontinuation due to lack of efficacy.||||0.7142
72491224|NCT00531752|144510572|SUPERIORITY_OR_OTHER||LS Mean Difference|56.631|STANDARD_ERROR_OF_MEAN|17.8056||0.0024|TWO_SIDED|80.0|33.532|79.73|||Mixed Models Analysis|||Week 1 (SPI I): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||79.730|33.532|0.0024
72491225|NCT00531752|144510572|SUPERIORITY_OR_OTHER||LS Mean Difference|49.1543|STANDARD_ERROR_OF_MEAN|18.7622||0.0112|TWO_SIDED|80.0|24.831|73.478|||Mixed Models Analysis|||Week 1 (SPI I): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||73.478|24.831|0.0112
72491226|NCT00531752|144510572|SUPERIORITY_OR_OTHER||LS Mean Difference|10.9197|STANDARD_ERROR_OF_MEAN|3.0912||0.0008|TWO_SIDED|80.0|6.9105|14.929|||Mixed Models Analysis|||Week 1 (SPI II): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||14.929|6.9105|0.0008
72491227|NCT00531752|144510572|SUPERIORITY_OR_OTHER||LS Mean Difference|8.4691|STANDARD_ERROR_OF_MEAN|3.3037||0.0129|TWO_SIDED|80.0|4.1876|12.751|||Mixed Models Analysis|||Week 1 (SPI II): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||12.751|4.1876|0.0129
72491228|NCT00531752|144510572|SUPERIORITY_OR_OTHER||LS Mean Difference|14.1078|STANDARD_ERROR_OF_MEAN|4.3667||0.002|TWO_SIDED|80.0|8.4492|19.766|||Mixed Models Analysis|||Week 2 (Sleep disturbance): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||19.766|8.4492|0.0020
72491229|NCT00531752|144510572|SUPERIORITY_OR_OTHER||LS Mean Difference|14.3485|STANDARD_ERROR_OF_MEAN|4.5692||0.0026|TWO_SIDED|80.0|8.4275|20.27|||Mixed Models Analysis|||Week 2 (Sleep disturbance): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||20.270|8.4275|0.0026
72491230|NCT00531752|144510572|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2989|STANDARD_ERROR_OF_MEAN|3.4103||0.9305|TWO_SIDED|80.0|-4.729|4.1309|||Mixed Models Analysis|||Week 2 (Snoring): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||4.1309|-4.729|0.9305
72491231|NCT00531752|144510572|SUPERIORITY_OR_OTHER||LS Mean Difference|-5.7062|STANDARD_ERROR_OF_MEAN|3.5839||0.1178|TWO_SIDED|80.0|-10.36|-1.05|||Mixed Models Analysis|||Week 2 (Snoring): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||-1.050|-10.36|0.1178
72517242|NCT02528253|144564413|SUPERIORITY||Odds Ratio (OR)|1.12||||0.396|TWO_SIDED|95.0|0.87|1.44|||Regression, Logistic|||Week 2: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline LBPI and treatment.||1.44|0.87|0.3960
72517243|NCT02528253|144564413|SUPERIORITY||Odds Ratio (OR)|0.93||||0.5932|TWO_SIDED|95.0|0.73|1.2|||Regression, Logistic|||Week 2: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline LBPI and treatment.||1.20|0.73|0.5932
72624729|NCT01346592|144778964|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (B strain)|8.0|||||TWO_SIDED|95.0|2.9|15.1||||||No risk subjects.||15.1|2.9|
72624730|NCT01346592|144778964|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (H1N1 strain)|-5.0|||||TWO_SIDED|95.0|-42.4|32.0||||||At risk subjects.||32|-42.4|
72491232|NCT00531752|144510572|SUPERIORITY_OR_OTHER||LS Mean Difference|2.4586|STANDARD_ERROR_OF_MEAN|2.5231||0.3339|TWO_SIDED|80.0|-0.8124|5.7295|||Mixed Models Analysis|||Week 2 (ASoB): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||5.7295|-0.8124|0.3339
72491233|NCT00531752|144510572|SUPERIORITY_OR_OTHER||LS Mean Difference|4.859|STANDARD_ERROR_OF_MEAN|2.63||0.0698|TWO_SIDED|80.0|1.4493|8.2686|||Mixed Models Analysis|||Week 2 (ASoB): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||8.2686|1.4493|0.0698
72491234|NCT00531752|144510572|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3364|STANDARD_ERROR_OF_MEAN|0.1859||0.0762|TWO_SIDED|80.0|-0.5777|-0.095|||Mixed Models Analysis|||Week 2 (Sleep quantity): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||-0.0950|-0.5777|0.0762
72517244|NCT02528253|144564413|SUPERIORITY||Odds Ratio (OR)|1.13||||0.3326|TWO_SIDED|95.0|0.88|1.46|||Regression, Logistic|||Week 4: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline LBPI and treatment.||1.46|0.88|0.3326
72517245|NCT02528253|144564413|SUPERIORITY||Odds Ratio (OR)|0.84||||0.1765|TWO_SIDED|95.0|0.65|1.08|||Regression, Logistic|||Week 4: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline LBPI and treatment.||1.08|0.65|0.1765
72404939|NCT01675882|144317173|SUPERIORITY||Difference in LS mean|73.9||||0.0372|TWO_SIDED|95.0|2.96|225.85||P-value was based on type III sum of squares from an ANCOVA model on log transformed values for the peanut protein eliciting dose at Month 12, including treatment group, baseline eliciting dose, age-strata and country as covariates.|ANCOVA|||The LS mean for any given treatment group is the estimated mean peanut protein eliciting dose for a participant in that treatment group with the mean value for all baseline covariates in the analysis set.||225.85|2.96|0.0372
72491235|NCT00531752|144510572|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1591|STANDARD_ERROR_OF_MEAN|0.1913||0.4096|TWO_SIDED|80.0|-0.4075|0.08935|||Mixed Models Analysis|||Week 2 (Sleep quantity): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||0.08935|-0.4075|0.4096
72491236|NCT00531752|144510572|SUPERIORITY_OR_OTHER||LS Mean Difference|0.2115|STANDARD_ERROR_OF_MEAN|0.1033||0.0455|TWO_SIDED|80.0|0.07751|0.3455|||Mixed Models Analysis|||Week 2 (Optimal sleep): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||0.34550|0.07751|0.0455
72491237|NCT00531752|144510572|SUPERIORITY_OR_OTHER||LS Mean Difference|0.08114|STANDARD_ERROR_OF_MEAN|0.1087||0.4585|TWO_SIDED|80.0|-0.0598|0.22209|||Mixed Models Analysis|||Week 2 (Optimal sleep): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||0.22209|-0.0598|0.4585
72517246|NCT02528253|144564413|SUPERIORITY||Odds Ratio (OR)|1.08||||0.5619|TWO_SIDED|95.0|0.84|1.39|||Regression, Logistic|||Week 8: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline LBPI and treatment.||1.39|0.84|0.5619
72491238|NCT00531752|144510572|SUPERIORITY_OR_OTHER||LS Mean Difference|0.5433|STANDARD_ERROR_OF_MEAN|4.6662||0.9078|TWO_SIDED|80.0|-5.513|6.5995|||Mixed Models Analysis|||Week 2 (Sleep adequacy): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||6.5995|-5.513|0.9078
72491239|NCT00531752|144510572|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.1848|STANDARD_ERROR_OF_MEAN|4.7892||0.6502|TWO_SIDED|80.0|-8.403|4.0338|||Mixed Models Analysis|||Week 2 (Sleep adequacy): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||4.0338|-8.403|0.6502
72491240|NCT00531752|144510572|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.9029|STANDARD_ERROR_OF_MEAN|3.7234||0.809|TWO_SIDED|80.0|-5.716|3.9101|||Mixed Models Analysis|||Week 2 (Somnolence): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||3.9101|-5.716|0.8090
72491241|NCT00531752|144510572|SUPERIORITY_OR_OTHER||LS Mean Difference|2.4351|STANDARD_ERROR_OF_MEAN|3.8429||0.5282|TWO_SIDED|80.0|-2.532|7.4025|||Mixed Models Analysis|||Week 2 (Somnolence): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||7.4025|-2.532|0.5282
72491242|NCT00531752|144510572|SUPERIORITY_OR_OTHER||LS Mean Difference|25.3231|STANDARD_ERROR_OF_MEAN|18.8604||0.1848|TWO_SIDED|80.0|0.86393|49.782|||Mixed Models Analysis|||Week 2 (SPI I): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||49.782|0.86393|0.1848
72491243|NCT00531752|144510572|SUPERIORITY_OR_OTHER||LS Mean Difference|50.4054|STANDARD_ERROR_OF_MEAN|19.481||0.0124|TWO_SIDED|80.0|25.134|75.677|||Mixed Models Analysis|||Week 2 (SPI I): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||75.677|25.134|0.0124
72491244|NCT00531752|144510572|SUPERIORITY_OR_OTHER||LS Mean Difference|6.8658|STANDARD_ERROR_OF_MEAN|3.0205||0.0267|TWO_SIDED|80.0|2.9504|10.781|||Mixed Models Analysis|||Week 2 (SPI II): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||10.781|2.9504|0.0267
72491245|NCT00531752|144510572|SUPERIORITY_OR_OTHER||LS Mean Difference|8.0855|STANDARD_ERROR_OF_MEAN|3.1677||0.0134|TWO_SIDED|80.0|3.9787|12.192|||Mixed Models Analysis|||Week 2 (SPI II): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||12.192|3.9787|0.0134
72491246|NCT00531752|144510572|SUPERIORITY_OR_OTHER||LS Mean Difference|9.5242|STANDARD_ERROR_OF_MEAN|3.7993||0.0152|TWO_SIDED|80.0|4.5949|14.453|||Mixed Models Analysis|||Week 3 (Sleep disturbance): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||14.453|4.5949|0.0152
72491247|NCT00531752|144510572|SUPERIORITY_OR_OTHER||LS Mean Difference|19.9806|STANDARD_ERROR_OF_MEAN|4.1501|<|0.0001|TWO_SIDED|80.0|14.602|25.359|||Mixed Models Analysis|||Week 3 (Sleep disturbance): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||25.359|14.602|<.0001
72517247|NCT02528253|144564413|SUPERIORITY||Odds Ratio (OR)|0.89||||0.3909|TWO_SIDED|95.0|0.69|1.16|||Regression, Logistic|||Week 8: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline LBPI and treatment.||1.16|0.69|0.3909
72404940|NCT01675882|144317173|SUPERIORITY||Difference in LS mean|96.7||||0.0143|TWO_SIDED|95.0|12.92|278.11||P-value was based on type III sum of squares from an ANCOVA model on log transformed values for the peanut protein eliciting dose at Month 12, including treatment group, baseline eliciting dose, age-strata and country as covariates.|ANCOVA|||The LS mean for any given treatment group is the estimated mean peanut protein eliciting dose for a participant in that treatment group with the mean value for all baseline covariates in the analysis set.||278.11|12.92|0.0143
72491248|NCT00531752|144510572|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.7667|STANDARD_ERROR_OF_MEAN|2.9402||0.3516|TWO_SIDED|80.0|-6.59|1.0562|||Mixed Models Analysis|||Week 3 (Snoring): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||1.0562|-6.590|0.3516
72517248|NCT02528253|144564413|SUPERIORITY||Odds Ratio (OR)|1.04||||0.7562|TWO_SIDED|95.0|0.8|1.35|||Regression, Logistic|||Week 12: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline LBPI and treatment.||1.35|0.80|0.7562
72624731|NCT01346592|144778964|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (H3N2 strain)|-10.0|||||TWO_SIDED|95.0|-41.2|16.6||||||At risk subjects.||16.6|-41.2|
72569230|NCT01000493|144669696|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.44||||0.1095|TWO_SIDED|95.0|-0.98|0.1||The MMRM analysis model included treatment, week, baseline CGI-S score, and the treatment by week and baseline by week interaction terms. Week was used as the repeated effect in the model.|MMRM analysis||Comparison between placebo and orvepitant 60 mg once daily at Week 10.|||0.10|-0.98|0.1095
72569231|NCT01000493|144669696|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.32||||0.2814|TWO_SIDED|95.0|-0.9|0.27||The MMRM analysis model included treatment, week, baseline CGI-S score, and the treatment by week and baseline by week interaction terms. Week was used as the repeated effect in the model.|MMRM analysis||Comparison between placebo and orvepitant 60 mg once daily at Week 12.|||0.27|-0.90|0.2814
72569232|NCT01000493|144669703|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.92||||0.0083|TWO_SIDED|95.0|-3.33|-0.5||The MMRM analysis model included treatment, week, Baseline total HAM-D score, and the treatment by week and Baseline by week interaction terms. Week was used as the repeated effect in the model.|MMRM analysis||Comparison between placebo and orvepitant 60 mg once daily at Week 1|||-0.50|-3.33|0.0083
72569233|NCT01000493|144669703|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.94||||0.0311|TWO_SIDED|95.0|-3.71|-0.18||The MMRM analysis model included treatment, week, Baseline total HAM-D score, and the treatment by week and Baseline by week interaction terms. Week was used as the repeated effect in the model.|MMRM analysis||Comparison between placebo and orvepitant 60 mg once daily at Week 2.|||-0.18|-3.71|0.0311
72569234|NCT01000493|144669703|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.89||||0.1155|TWO_SIDED|95.0|-4.26|0.47||The MMRM analysis model included treatment, week, Baseline total HAM-D score, and the treatment by week and Baseline by week interaction terms. Week was used as the repeated effect in the model.|MMRM analysis||Comparison between placebo and orvepitant 60 mg once daily at Week 4.|||0.47|-4.26|0.1155
72569235|NCT01000493|144669703|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.89||||0.021|TWO_SIDED|95.0|-5.33|-0.45||The MMRM analysis model included treatment, week, Baseline total HAM-D score, and the treatment by week and Baseline by week interaction terms. Week was used as the repeated effect in the model.|MMRM analysis||Comparison between placebo and orvepitant 60 mg once daily at Week 6.|||-0.45|-5.33|0.0210
72569236|NCT01000493|144669703|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.86||||0.0582|TWO_SIDED|95.0|-5.83|0.1||The MMRM analysis model included treatment, week, Baseline total HAM-D score, and the treatment by week and Baseline by week interaction terms. Week was used as the repeated effect in the model.|MMRM analysis||Comparison between placebo and orvepitant 60 mg once daily at Week 8.|||0.10|-5.83|0.0582
72624732|NCT01346592|144778964|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (B strain)|25.0|||||TWO_SIDED|95.0|-7.1|53.9||||||At risk subjects.||53.9|-7.1|
72624733|NCT01346592|144778964|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (H1N1 strain)|8.0|||||TWO_SIDED|95.0|1.0|16.4||||||No risk subjects.||16.4|1|
72491249|NCT00531752|144510572|SUPERIORITY_OR_OTHER||LS Mean Difference|3.0838|STANDARD_ERROR_OF_MEAN|3.2323||0.3448|TWO_SIDED|80.0|-1.116|7.2838|||Mixed Models Analysis|||Week 3 (Snoring): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||7.2838|-1.116|0.3448
72624734|NCT01346592|144778964|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (H3N2 strain)|8.0|||||TWO_SIDED|95.0|2.0|16.1||||||No risk subjects.||16.1|2|
72624735|NCT01346592|144778964|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (B strain)|4.0|||||TWO_SIDED|95.0|0.0|10.0||||||No risk subjects.||10|0|
72624736|NCT01346592|144778964|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (H1N1 strain)|-1.0|||||TWO_SIDED|95.0|-42.1|43.0||||||At risk subjects.||43|-42.1|
72569237|NCT01000493|144669703|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.88||||0.0927|TWO_SIDED|95.0|-6.25|0.49||The MMRM analysis model included treatment, week, Baseline total HAM-D score, and the treatment by week and Baseline by week interaction terms. Week was used as the repeated effect in the model.|MMRM analysis||Comparison between placebo and orvepitant 60 mg once daily at Week 10.|||0.49|-6.25|0.0927
72569238|NCT01000493|144669703|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.27||||0.8954|TWO_SIDED|95.0|-4.36|3.83||The MMRM analysis model included treatment, week, Baseline total HAM-D score, and the treatment by week and Baseline by week interaction terms. Week was used as the repeated effect in the model.|MMRM analysis||Comparison between placebo and orvepitant 60 mg once daily at Week 12.|||3.83|-4.36|0.8954
72569239|NCT01565616|144669719|OTHER||Mean Difference (Net)|-1.7|STANDARD_DEVIATION|10.4||0.52|TWO_SIDED||||||t-test, 2 sided|||This statistical analysis is the paired difference in t-scores of the anxiety domain of the PROMIS-57 quality of life scale. 16 participants with paired measurements of the PROMIS-57 survey (baseline and 1 year) are included in this analysis.||||0.52
72569240|NCT01565616|144669719|OTHER||Mean Difference (Net)|2.7|STANDARD_DEVIATION|6.4||0.12|TWO_SIDED||||||t-test, 2 sided|||This statistical analysis is the paired difference in t-scores of the depression domain of the PROMIS-57 quality of life scale. 16 participants with paired measurements of the PROMIS-57 survey (baseline and 1 year) are included in this analysis.||||0.12
72569241|NCT01565616|144669719|OTHER||Mean Difference (Net)|-1.3|STANDARD_DEVIATION|8.5||0.54|TWO_SIDED||||||t-test, 2 sided|||This statistical analysis is the paired difference in t-scores of the fatigue domain of the PROMIS-57 quality of life scale. 16 participants with paired measurements of the PROMIS-57 survey (baseline and 1 year) are included in this analysis.||||0.54
72569242|NCT01565616|144669719|OTHER||Mean Difference (Net)|-7.5|STANDARD_DEVIATION|9.3||0.006|TWO_SIDED||||||t-test, 2 sided|||This statistical analysis is the paired difference in t-scores of the pain interference domain of the PROMIS-57 quality of life scale. 16 participants with paired measurements of the PROMIS-57 survey (baseline and 1 year) are included in this analysis.||||0.006
72569243|NCT01565616|144669719|OTHER||Mean Difference (Net)|5.8|STANDARD_DEVIATION|10.5||0.044|TWO_SIDED||||||t-test, 2 sided|||This statistical analysis is the paired difference in t-scores of the physical function domain of the PROMIS-57 quality of life scale. 16 participants with paired measurements of the PROMIS-57 survey (baseline and 1 year) are included in this analysis.||||0.044
72491250|NCT00531752|144510572|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.5882|STANDARD_ERROR_OF_MEAN|4.3902||0.5583|TWO_SIDED|80.0|-8.294|3.1175|||Mixed Models Analysis|||Week 3 (ASoB): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||3.1175|-8.294|0.5583
72491251|NCT00531752|144510572|SUPERIORITY_OR_OTHER||LS Mean Difference|7.6547|STANDARD_ERROR_OF_MEAN|4.7652||0.1141|TWO_SIDED|80.0|1.4717|13.838|||Mixed Models Analysis|||Week 3 (ASoB): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||13.838|1.4717|0.1141
72491252|NCT00531752|144510572|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.5882|STANDARD_ERROR_OF_MEAN|0.1903||0.0034|TWO_SIDED|80.0|-0.8356|-0.3408|||Mixed Models Analysis|||Week 3 (Sleep quantity): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||-0.3408|-0.8356|0.0034
72491253|NCT00531752|144510572|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1722|STANDARD_ERROR_OF_MEAN|0.2064||0.4083|TWO_SIDED|80.0|-0.4403|0.09599|||Mixed Models Analysis|||Week 3 (Sleep quantity): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||0.09599|-0.4403|0.4083
72491254|NCT00531752|144510572|SUPERIORITY_OR_OTHER||LS Mean Difference|0.2744|STANDARD_ERROR_OF_MEAN|0.1055||0.012|TWO_SIDED|80.0|0.13746|0.41127|||Mixed Models Analysis|||Week 3 (Optimal sleep): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||0.41127|0.13746|0.0120
72491255|NCT00531752|144510572|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1016|STANDARD_ERROR_OF_MEAN|0.1136||0.375|TWO_SIDED|80.0|-0.0457|0.24881|||Mixed Models Analysis|||Week 3 (Optimal sleep): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||0.24881|-0.0457|0.3750
72491256|NCT00531752|144510572|SUPERIORITY_OR_OTHER||LS Mean Difference|0.4367|STANDARD_ERROR_OF_MEAN|3.9301||0.9119|TWO_SIDED|80.0|-4.665|5.5387|||Mixed Models Analysis|||Week 3 (Sleep adequacy): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||5.5387|-4.665|0.9119
72491257|NCT00531752|144510572|SUPERIORITY_OR_OTHER||LS Mean Difference|-6.3429|STANDARD_ERROR_OF_MEAN|4.1977||0.1367|TWO_SIDED|80.0|-11.79|-0.896|||Mixed Models Analysis|||Week 3 (Sleep adequacy): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||-0.8960|-11.79|0.1367
72491258|NCT00531752|144510572|SUPERIORITY_OR_OTHER||LS Mean Difference|-6.0062|STANDARD_ERROR_OF_MEAN|3.1094||0.0595|TWO_SIDED|80.0|-10.05|-1.964|||Mixed Models Analysis|||Week 3 (Somnolence): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||-1.964|-10.05|0.0595
72491259|NCT00531752|144510572|SUPERIORITY_OR_OTHER||LS Mean Difference|5.0362|STANDARD_ERROR_OF_MEAN|3.3182||0.1356|TWO_SIDED|80.0|0.72505|9.3473|||Mixed Models Analysis|||Week 3 (Somnolence): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||9.3473|0.72505|0.1356
72491260|NCT00531752|144510572|SUPERIORITY_OR_OTHER||LS Mean Difference|5.1569|STANDARD_ERROR_OF_MEAN|16.2884||0.7528|TWO_SIDED|80.0|-15.99|26.303|||Mixed Models Analysis|||Week 3 (SPI I): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||26.303|-15.99|0.7528
72517249|NCT02528253|144564413|SUPERIORITY||Odds Ratio (OR)|1.01||||0.9476|TWO_SIDED|95.0|0.78|1.31|||Regression, Logistic|||Week 12: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline LBPI and treatment.||1.31|0.78|0.9476
72517250|NCT02528253|144564413|SUPERIORITY||Odds Ratio (OR)|1.04||||0.7746|TWO_SIDED|95.0|0.79|1.36|||Regression, Logistic|||Week 16: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline LBPI and treatment.||1.36|0.79|0.7746
72517251|NCT02528253|144564413|SUPERIORITY||Odds Ratio (OR)|0.94||||0.6377|TWO_SIDED|95.0|0.71|1.23|||Regression, Logistic|||Week 16: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline LBPI and treatment.||1.23|0.71|0.6377
72517252|NCT02528253|144564413|SUPERIORITY||Odds Ratio (OR)|1.03||||0.8532|TWO_SIDED|95.0|0.79|1.33|||Regression, Logistic|||Week 24: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline LBPI and treatment.||1.33|0.79|0.8532
72517253|NCT02528253|144564413|SUPERIORITY||Odds Ratio (OR)|1.08||||0.5644|TWO_SIDED|95.0|0.83|1.4|||Regression, Logistic|||Week 24: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline LBPI and treatment.||1.40|0.83|0.5644
72624737|NCT01346592|144778964|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (H3N2 strain)|-10.0|||||TWO_SIDED|95.0|-41.5|28.7||||||At risk subjects||28.7|-41.5|
72624738|NCT01346592|144778964|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (B strain)|0.0|||||TWO_SIDED|95.0|-29.0|36.8||||||At risk subjects.||36.8|-29|
72491261|NCT00531752|144510572|SUPERIORITY_OR_OTHER||LS Mean Difference|67.7022|STANDARD_ERROR_OF_MEAN|17.4066||0.0003|TWO_SIDED|80.0|45.114|90.29|||Mixed Models Analysis|||Week 3 (SPI I): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||90.290|45.114|0.0003
72491262|NCT00531752|144510572|SUPERIORITY_OR_OTHER||LS Mean Difference|2.8582|STANDARD_ERROR_OF_MEAN|2.6389||0.2837|TWO_SIDED|80.0|-0.567|6.2835|||Mixed Models Analysis|||Week 3 (SPI II): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||6.2835|-0.5670|0.2837
72491263|NCT00531752|144510572|SUPERIORITY_OR_OTHER||LS Mean Difference|12.9251|STANDARD_ERROR_OF_MEAN|2.8913|<|0.0001|TWO_SIDED|80.0|9.1761|16.674|||Mixed Models Analysis|||Week 3 (SPI II): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||16.674|9.1761|<0.0001
72517254|NCT02528253|144564413|SUPERIORITY||Odds Ratio (OR)|1.04||||0.769|TWO_SIDED|0.769|0.8|1.35|||Regression, Logistic|||Week 32: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline LBPI and treatment.||1.35|0.80|0.7690
72569244|NCT01565616|144669719|OTHER||Mean Difference (Net)|0.6|STANDARD_DEVIATION|11.8||0.85|TWO_SIDED||||||t-test, 2 sided|||This statistical analysis is the paired difference in t-scores of the satisfaction with social role domain of the PROMIS-57 quality of life scale. 16 participants with paired measurements of the PROMIS-57 survey (baseline and 1 year) are included in this analysis.||||0.85
72569245|NCT01565616|144669719|OTHER||Mean Difference (Net)|0.5|STANDARD_DEVIATION|13.5||0.88|TWO_SIDED||||||t-test, 2 sided|||This statistical analysis is the paired difference in t-scores of the sleep disturbances domain of the PROMIS-57 quality of life scale. 16 participants with paired measurements of the PROMIS-57 survey (baseline and 1 year) are included in this analysis.||||0.88
72491264|NCT00531752|144510573|SUPERIORITY_OR_OTHER||LS Mean Difference|26.8615|STANDARD_ERROR_OF_MEAN|3.9167|<|0.0001|TWO_SIDED|80.0|21.777|31.946|||Mixed Models Analysis|||Week 1: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||31.946|21.777|<0.0001
72491265|NCT00531752|144510573|SUPERIORITY_OR_OTHER||LS Mean Difference|4.3455|STANDARD_ERROR_OF_MEAN|4.1817||0.3034|TWO_SIDED|80.0|-1.08|9.7713|||Mixed Models Analysis|||Week 1: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||9.7713|-1.080|0.3034
72491266|NCT00531752|144510573|SUPERIORITY_OR_OTHER||LS Mean Difference|6.9558|STANDARD_ERROR_OF_MEAN|2.9408||0.0223|TWO_SIDED|80.0|3.132|10.78|||Mixed Models Analysis|||Week 2: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||10.780|3.1320|0.0223
72491267|NCT00531752|144510573|SUPERIORITY_OR_OTHER||LS Mean Difference|3.7518|STANDARD_ERROR_OF_MEAN|3.0743||0.2284|TWO_SIDED|80.0|-0.2442|7.7479|||Mixed Models Analysis|||Week 2: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||7.7479|-0.2442|0.2284
72491268|NCT00531752|144510573|SUPERIORITY_OR_OTHER||LS Mean Difference|8.5752|STANDARD_ERROR_OF_MEAN|3.5848||0.0201|TWO_SIDED|80.0|3.9265|13.224|||Mixed Models Analysis|||Week 3: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||13.224|3.9265|0.0201
72491269|NCT00531752|144510573|SUPERIORITY_OR_OTHER||LS Mean Difference|5.0229|STANDARD_ERROR_OF_MEAN|3.8154||0.1931|TWO_SIDED|80.0|0.07753|9.9683|||Mixed Models Analysis|||Week 3: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||9.9683|0.07753|0.1931
72491270|NCT00531752|144510574|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.6766|STANDARD_ERROR_OF_MEAN|0.1759||0.0003|TWO_SIDED|80.0|-0.9046|-0.4487|||Mixed Models Analysis|||Week 1: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||-0.4487|-0.9046|0.0003
72569246|NCT01565616|144669719|OTHER||Mean Difference (Net)|-0.5|STANDARD_DEVIATION|3.1||0.53|TWO_SIDED||||||t-test, 2 sided|||This statistical analysis is the paired difference in raw scores of the pain intensity domain of the PROMIS-57 quality of life scale. 16 participants with paired measurements of the PROMIS-57 survey (baseline and 1 year) are included in this analysis.||||0.53
72624739|NCT01346592|144778965|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (H1N1 strain)|10.0|||||TWO_SIDED|95.0|6.4|12.8||||||No risk subjects.||12.8|6.4|
72624740|NCT01346592|144778965|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (H3N2 strain)|4.0|||||TWO_SIDED|95.0|1.8|6.4||||||No risk subjects.||6.4|1.8|
72624741|NCT01346592|144778965|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (B strain)|11.0|||||TWO_SIDED|95.0|8.6|13.9||||||No risk subjects.||13.9|8.6|
72624742|NCT01346592|144778965|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (H1N1 strain)|-4.0|||||TWO_SIDED|95.0|-24.7|14.9||||||At risk subjects.||14.9|-24.7|
72624743|NCT01346592|144778965|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (H3N2 strain)|4.0|||||TWO_SIDED|95.0|-14.4|20.7||||||At risk subjects.||20.7|-14.4|
72624744|NCT01346592|144778965|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (B strain)|9.0|||||TWO_SIDED|95.0|-6.8|23.4||||||At risk subjects.||23.4|-6.8|
72624745|NCT01346592|144778965|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (H1N1 strain)|15.0|||||TWO_SIDED|95.0|11.3|18.1||||||No risk subjects.||18.1|11.3|
72624746|NCT01346592|144778965|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (H3N2 strain)|7.0|||||TWO_SIDED|95.0|4.2|9.1||||||No risk subjects.||9.1|4.2|
72624747|NCT01346592|144778965|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (B strain)|13.0|||||TWO_SIDED|95.0|10.5|16.1||||||No risk subjects.||16.1|10.5|
72624748|NCT01346592|144778965|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (H1N1 strain)|-4.0|||||TWO_SIDED|95.0|-25.3|15.4||||||At risk subjects||15.4|-25.3|
72624749|NCT01346592|144778965|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (H3N2 strain)|6.0|||||TWO_SIDED|95.0|-12.7|24.2||||||At risk subjects.||24.2|-12.7|
72624750|NCT01346592|144778965|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group differences (B strain)|8.0|||||TWO_SIDED|95.0|-7.8|23.2||||||At risk subjects.||23.2|-7.8|
72624751|NCT01346592|144778965|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (H1N1 strain)|12.0|||||TWO_SIDED|95.0|8.2|15.3||||||No risk subjects.||15.3|8.2|
72569247|NCT00444457|144669736|NON_INFERIORITY_OR_EQUIVALENCE|The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.|difference in log-transformed GM|-0.01|||||TWO_SIDED|95.0|-0.11|0.09|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Common serotypes - serotype 4||0.09|-0.11|
72569248|NCT00444457|144669736|NON_INFERIORITY_OR_EQUIVALENCE|The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.|Difference in log-transformed GM|-0.27|||||TWO_SIDED|95.0|-0.38|-0.17|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Common serotypes - serotype 4||-0.17|-0.38|
72569249|NCT00444457|144669736|NON_INFERIORITY_OR_EQUIVALENCE|The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.|Difference in log-transformed GM|-0.27|||||TWO_SIDED|95.0|-0.37|-0.16|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Common serotypes - serotype 4||-0.16|-0.37|
72569250|NCT00444457|144669736|NON_INFERIORITY_OR_EQUIVALENCE|The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.|Difference in log-transformed GM|0.3|||||TWO_SIDED|95.0|0.13|0.46|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Common serotypes - serotype 6B||0.46|0.13|
72569251|NCT00444457|144669736|NON_INFERIORITY_OR_EQUIVALENCE|The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.|Difference in log-transformed GM|0.13|||||TWO_SIDED|95.0|-0.04|0.29|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Common serotypes - serotype 6B||0.29|-0.04|
72569252|NCT00444457|144669736|NON_INFERIORITY_OR_EQUIVALENCE|The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.|Difference in log-transformed GM|-0.17|||||TWO_SIDED|95.0|-0.33|-0.01|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Common serotypes - serotype 6B||-0.01|-0.33|
72569253|NCT00444457|144669736|NON_INFERIORITY_OR_EQUIVALENCE|The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.|Difference in log-transformed GM|-0.06|||||TWO_SIDED|95.0|-0.16|0.04|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Common serotypes - serotype 9V||0.04|-0.16|
72569254|NCT00444457|144669736|NON_INFERIORITY_OR_EQUIVALENCE|The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.|Difference in log-transformed GM|-0.06|||||TWO_SIDED|95.0|-0.16|0.04|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Common serotypes - serotype 9V||0.04|-0.16|
72624752|NCT01346592|144778965|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (H3N2 strain)|5.0|||||TWO_SIDED|95.0|2.5|7.4||||||No risk subjects.||7.4|2.5|
72624753|NCT01346592|144778965|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (B strain)|12.0|||||TWO_SIDED|95.0|9.2|15.3||||||No risk subjects.||15.3|9.2|
72491271|NCT00531752|144510574|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3075|STANDARD_ERROR_OF_MEAN|0.1871||0.1055|TWO_SIDED|80.0|-0.5499|-0.065|||Mixed Models Analysis|||Week 1: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||-0.0650|-0.5499|0.1055
72491272|NCT00531752|144510574|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4684|STANDARD_ERROR_OF_MEAN|0.1791||0.0119|TWO_SIDED|80.0|-0.7012|-0.2356|||Mixed Models Analysis|||Week 2: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||-0.2356|-0.7012|0.0119
72569255|NCT00444457|144669736|NON_INFERIORITY_OR_EQUIVALENCE|The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.|Difference in log-transformed GM|0.0|||||TWO_SIDED|95.0|-0.1|0.1|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Common serotypes - serotype 9V||0.10|-0.10|
72569256|NCT00444457|144669736|NON_INFERIORITY_OR_EQUIVALENCE|The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.|Difference in log-transformed GM|-0.03|||||TWO_SIDED|95.0|-0.15|0.09|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Common serotypes - serotype 14||0.09|-0.15|
72569257|NCT00444457|144669736|NON_INFERIORITY_OR_EQUIVALENCE|The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.|Difference in log-transformed GM|-0.04|||||TWO_SIDED|95.0|-0.16|0.08|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Common serotypes - serotype 14||0.08|-0.16|
72404941|NCT01675882|144317173|SUPERIORITY||Difference in LS mean|260.3|||<|0.0001|TWO_SIDED|95.0|89.83|625.95||P-value was based on type III sum of squares from an ANCOVA model on log transformed values for the peanut protein eliciting dose at Month 12, including treatment group, baseline eliciting dose, age-strata and country as covariates.|ANCOVA|||The LS mean for any given treatment group is the estimated mean peanut protein eliciting dose for a participant in that treatment group with the mean value for all baseline covariates in the analysis set.||625.95|89.83|<0.0001
72517255|NCT02528253|144564413|SUPERIORITY||Odds Ratio (OR)|1.11||||0.4321|TWO_SIDED|95.0|0.85|1.44|||Regression, Logistic|||Week 32: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline LBPI and treatment.||1.44|0.85|0.4321
72517256|NCT02528253|144564413|SUPERIORITY||Odds Ratio (OR)|1.04||||0.7714|TWO_SIDED|95.0|0.8|1.35|||Regression, Logistic|||Week 40: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline LBPI and treatment.||1.35|0.80|0.7714
72517257|NCT02528253|144564413|SUPERIORITY||Odds Ratio (OR)|1.03||||0.8389|TWO_SIDED|95.0|0.79|1.34|||Regression, Logistic|||Week 40: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline LBPI and treatment.||1.34|0.79|0.8389
72517258|NCT02528253|144564413|SUPERIORITY||Odds Ratio (OR)|0.99||||0.9383|TWO_SIDED|95.0|0.76|1.29|||Regression, Logistic|||Week 48: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline LBPI and treatment.||1.29|0.76|0.9383
72517259|NCT02528253|144564413|SUPERIORITY||Odds Ratio (OR)|1.02||||0.88|TWO_SIDED|95.0|0.78|1.33|||Regression, Logistic|||Week 48: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline LBPI and treatment.||1.33|0.78|0.8800
72517260|NCT02528253|144564413|SUPERIORITY||Odds Ratio (OR)|0.97||||0.7946|TWO_SIDED|95.0|0.74|1.26|||Regression, Logistic|||Week 56: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline LBPI and treatment.||1.26|0.74|0.7946
72517261|NCT02528253|144564413|SUPERIORITY||Odds Ratio (OR)|0.96||||0.7803|TWO_SIDED|95.0|0.74|1.25|||Regression, Logistic|||Week 56: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline LBPI and treatment.||1.25|0.74|0.7803
72517262|NCT02528253|144564415|SUPERIORITY||LS Mean Ratio|1.16|STANDARD_ERROR_OF_MEAN|0.11||0.1272|TWO_SIDED|95.0|0.96|1.41|||Negative binomial model|||Week 2: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.||1.41|0.96|0.1272
72517263|NCT02528253|144564415|SUPERIORITY||LS Mean Ratio|1.05|STANDARD_ERROR_OF_MEAN|0.1||0.6322|TWO_SIDED|95.0|0.86|1.27|||Negative binomial model|||Week 2: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.||1.27|0.86|0.6322
72517264|NCT02528253|144564415|SUPERIORITY||LS Mean Ratio|1.1|STANDARD_ERROR_OF_MEAN|0.12||0.3559|TWO_SIDED|95.0|0.89|1.36|||Negative binomial model|||Week 4: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.||1.36|0.89|0.3559
72404942|NCT01675882|144317174|SUPERIORITY||Difference in LS mean|26.1||||0.6596|TWO_SIDED|95.0|-59.58|236.0||P-value was based on type III sum of squares from an ANCOVA model on log transformed values for the peanut protein eliciting dose at Month 12, including treatment group, baseline eliciting dose, age-strata and country as covariates.|ANCOVA|||The LS mean for any given treatment group is the estimated mean peanut protein eliciting dose for a participant in that treatment group with the mean value for all baseline covariates in the analysis set.||236.00|-59.58|0.6596
72491273|NCT00531752|144510574|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1263|STANDARD_ERROR_OF_MEAN|0.1866||0.5016|TWO_SIDED|80.0|-0.3687|0.11608|||Mixed Models Analysis|||Week 2: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||0.11608|-0.3687|0.5016
72491274|NCT00531752|144510574|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3451|STANDARD_ERROR_OF_MEAN|0.1738||0.0531|TWO_SIDED|80.0|-0.5711|-0.1191|||Mixed Models Analysis|||Week 3: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||-0.1191|-0.5711|0.0531
72491275|NCT00531752|144510574|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4137|STANDARD_ERROR_OF_MEAN|0.1856||0.0306|TWO_SIDED|80.0|-0.6549|-0.1725|||Mixed Models Analysis|||Week 3: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||-0.1725|-0.6549|0.0306
72491276|NCT00531752|144510575|SUPERIORITY_OR_OTHER||LS Mean Difference|0.7671|STANDARD_ERROR_OF_MEAN|0.1731|<|0.0001|TWO_SIDED|80.0|0.5426|0.99157|||Mixed Models Analysis|||Week 1: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||0.99157|0.54260|<0.0001
72491277|NCT00531752|144510575|SUPERIORITY_OR_OTHER||LS Mean Difference|0.5285|STANDARD_ERROR_OF_MEAN|0.1847||0.0059|TWO_SIDED|80.0|0.28911|0.76798|||Mixed Models Analysis|||Week 1: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||0.76798|0.28911|0.0059
72491278|NCT00531752|144510575|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1526|STANDARD_ERROR_OF_MEAN|0.1431||0.2921|TWO_SIDED|80.0|-0.0336|0.33878|||Mixed Models Analysis|||Week 2: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||0.33878|-0.0336|0.2921
72491279|NCT00531752|144510575|SUPERIORITY_OR_OTHER||LS Mean Difference|0.198|STANDARD_ERROR_OF_MEAN|0.1498||0.1929|TWO_SIDED|80.0|0.00319|0.39272|||Mixed Models Analysis|||Week 2: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||0.39272|0.00319|0.1929
72491280|NCT00531752|144510575|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3433|STANDARD_ERROR_OF_MEAN|0.1565||0.0332|TWO_SIDED|80.0|0.13988|0.54663|||Mixed Models Analysis|||Week 3: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||0.54663|0.13988|0.0332
72491281|NCT00531752|144510575|SUPERIORITY_OR_OTHER||LS Mean Difference|0.4184|STANDARD_ERROR_OF_MEAN|0.1681||0.0162|TWO_SIDED|80.0|0.20006|0.63674|||Mixed Models Analysis|||Week 3: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||0.63674|0.20006|0.0162
72491282|NCT00531752|144510576|SUPERIORITY_OR_OTHER||LS Mean Difference|0.5103|STANDARD_ERROR_OF_MEAN|0.1103|<|0.0001|TWO_SIDED|80.0|0.36707|0.65345|||Mixed Models Analysis|||Week 1: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||0.65345|0.36707|<0.0001
72491283|NCT00531752|144510576|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3643|STANDARD_ERROR_OF_MEAN|0.1174||0.0031|TWO_SIDED|80.0|0.21189|0.51664|||Mixed Models Analysis|||Week 1: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||0.51664|0.21189|0.0031
72491284|NCT00531752|144510576|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1362|STANDARD_ERROR_OF_MEAN|0.09408||0.1553|TWO_SIDED|80.0|0.01366|0.25882|||Mixed Models Analysis|||Week 2: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||0.25882|0.01366|0.1553
72491285|NCT00531752|144510576|SUPERIORITY_OR_OTHER||LS Mean Difference|0.107|STANDARD_ERROR_OF_MEAN|0.09797||0.2809|TWO_SIDED|80.0|-0.0205|0.23458|||Mixed Models Analysis|||Week 2: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||0.23458|-0.0205|0.2809
72491286|NCT00531752|144510576|SUPERIORITY_OR_OTHER||LS Mean Difference|0.2195|STANDARD_ERROR_OF_MEAN|0.1146||0.0603|TWO_SIDED|80.0|0.07101|0.36803|||Mixed Models Analysis|||Week 3: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||0.36803|0.07101|0.0603
72491287|NCT00531752|144510576|SUPERIORITY_OR_OTHER||LS Mean Difference|0.4278|STANDARD_ERROR_OF_MEAN|0.1212||0.0008|TWO_SIDED|80.0|0.27079|0.58479|||Mixed Models Analysis|||Week 3: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||0.58479|0.27079|0.0008
72491288|NCT00531752|144510577|SUPERIORITY_OR_OTHER||LS Mean Difference|-13.3264|STANDARD_ERROR_OF_MEAN|2.6944|<|0.0001|TWO_SIDED|80.0|-16.83|-9.828|||Mixed Models Analysis|||Week 1: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||-9.828|-16.83|<0.0001
72517265|NCT02528253|144564415|SUPERIORITY||LS Mean Ratio|0.96||||0.6798|TWO_SIDED|95.0|0.77|1.18|||Negative binomial model|||Week 4: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.||1.18|0.77|0.6798
72517266|NCT02528253|144564415|SUPERIORITY||LS Mean Ratio|1.14||||0.267|TWO_SIDED|95.0|0.9|1.44|||Negative binomial model|||Week 8: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.||1.44|0.90|0.2670
72517267|NCT02528253|144564415|SUPERIORITY||LS Mean Ratio|0.94||||0.5865|TWO_SIDED|95.0|0.74|1.19|||Negative binomial model|||Week 8: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.||1.19|0.74|0.5865
72517268|NCT02528253|144564415|SUPERIORITY||LS Mean Ratio|1.13||||0.3378|TWO_SIDED|95.0|0.88|1.47|||Negative binomial model|||Week 12: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.||1.47|0.88|0.3378
72569258|NCT00444457|144669736|NON_INFERIORITY_OR_EQUIVALENCE|The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.|Difference in log-transformed GM|-0.01|||||TWO_SIDED|95.0|-0.13|0.11|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Common serotypes - serotype 14||0.11|-0.13|
72569259|NCT00444457|144669736|NON_INFERIORITY_OR_EQUIVALENCE|The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.|Difference in log-transformed GM|-0.03|||||TWO_SIDED|95.0|-0.13|0.07|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Common serotypes - serotype 18C||0.07|-0.13|
72569260|NCT00444457|144669736|NON_INFERIORITY_OR_EQUIVALENCE|The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.|Difference in log-transformed GM|-0.13|||||TWO_SIDED|95.0|-0.23|-0.03|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Common serotypes - serotype 18C||-0.03|-0.23|
72569261|NCT00444457|144669736|NON_INFERIORITY_OR_EQUIVALENCE|The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.|Difference in log-transformed GM|-0.1|||||TWO_SIDED|95.0|-0.2|0.0|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Common serotypes - serotype 18C||-0.00|-0.20|
72569262|NCT00444457|144669736|NON_INFERIORITY_OR_EQUIVALENCE|The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.|Difference in log-transformed GM|-0.11|||||TWO_SIDED|95.0|-0.22|-0.01|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Common serotypes - serotype 19F||-0.01|-0.22|
72569263|NCT00444457|144669736|NON_INFERIORITY_OR_EQUIVALENCE|The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.|Difference in log-transformed GM|-0.34|||||TWO_SIDED|95.0|-0.44|-0.23|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Common serotypes - serotype 19F||-0.23|-0.44|
72569264|NCT00444457|144669736|NON_INFERIORITY_OR_EQUIVALENCE|The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.|Difference in log-transformed GM|-0.22|||||TWO_SIDED|95.0|-0.33|-0.11|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Common serotypes - serotype 19F||-0.11|-0.33|
72569265|NCT00444457|144669736|NON_INFERIORITY_OR_EQUIVALENCE|The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.|Difference in log-transformed GM|-0.03|||||TWO_SIDED|95.0|-0.16|0.11|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Common serotypes - serotype 23F||0.11|-0.16|
72569266|NCT00444457|144669736|NON_INFERIORITY_OR_EQUIVALENCE|The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.|Difference in log-transformed GM|0.18|||||TWO_SIDED|95.0|0.04|0.31|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Common serotypes - serotype 23F||0.31|0.04|
72624754|NCT01346592|144778965|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (H1N1 strain)|-2.0|||||TWO_SIDED|95.0|-28.5|20.2||||||At risk subjects.||20.2|-28.5|
72569267|NCT00444457|144669736|NON_INFERIORITY_OR_EQUIVALENCE|The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.|Difference in log-transformed GM|0.2|||||TWO_SIDED|95.0|0.07|0.34|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Common serotypes - serotype 23F||0.34|0.07|
72569268|NCT00444457|144669736|NON_INFERIORITY_OR_EQUIVALENCE|The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.|Difference in log-transformed GM|-0.11|||||TWO_SIDED|95.0|-0.23|0.01|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Additional serotypes - serotype 1||0.01|-0.23|
72569269|NCT00444457|144669736|NON_INFERIORITY_OR_EQUIVALENCE|The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.|Difference in log-transformed GM|-0.16|||||TWO_SIDED|95.0|-0.28|-0.04|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Additional serotypes - serotype 1||-0.04|-0.28|
72624755|NCT01346592|144778965|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (H3N2 strain)|11.0|||||TWO_SIDED|95.0|-14.9|33.5||||||At risk subjects.||33.5|-14.9|
72491289|NCT00531752|144510577|SUPERIORITY_OR_OTHER||LS Mean Difference|-8.126|STANDARD_ERROR_OF_MEAN|2.8841||0.0068|TWO_SIDED|80.0|-11.87|-4.382|||Mixed Models Analysis|||Week 1: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||-4.382|-11.87|0.0068
72624756|NCT01346592|144778965|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (B strain)|2.0|||||TWO_SIDED|95.0|-20.7|19.7||||||At risk subjects.||19.7|-20.7|
72491290|NCT00531752|144510577|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.5341|STANDARD_ERROR_OF_MEAN|2.3172||0.1346|TWO_SIDED|80.0|-6.551|-0.5175|||Mixed Models Analysis|||Week 2: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||-0.5175|-6.551|0.1346
72491291|NCT00531752|144510577|SUPERIORITY_OR_OTHER||LS Mean Difference|1.0911|STANDARD_ERROR_OF_MEAN|2.4268||0.6552|TWO_SIDED|80.0|-2.067|4.2494|||Mixed Models Analysis|||Week 2: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||4.2494|-2.067|0.6552
72491292|NCT00531752|144510577|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.2001|STANDARD_ERROR_OF_MEAN|1.7614||0.0765|TWO_SIDED|80.0|-5.494|-0.9063|||Mixed Models Analysis|||Week 3: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||-0.9063|-5.494|0.0765
72491293|NCT00531752|144510577|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.8781|STANDARD_ERROR_OF_MEAN|1.8976||0.0473|TWO_SIDED|80.0|-6.349|-1.407|||Mixed Models Analysis|||Week 3: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||-1.407|-6.349|0.0473
72491294|NCT00401375|144510583|OTHER||Mean Difference (Final Values)|-0.23||||0.4259||||||Threshold for significance at 0.05 level.|Log Rank|||Treatment comparisons were made at the overall α=0.05 level (2-sided) using a closed sequential procedure. Placebo and MNTX 24 mg groups were compared first.||||0.4259
72491295|NCT00401375|144510583|OTHER||Mean Difference (Final Values)|0.13||||0.3575||||||Threshold for significance at 0.05 level.|Log Rank|||Treatment comparisons were made at the overall α=0.05 level (2-sided) using a closed sequential procedure. Placebo and MNTX 24 mg groups were compared first.||||0.3575
72491296|NCT00950664|144510587|NON_INFERIORITY_OR_EQUIVALENCE|81 participants required to detect 5 difference in Tsui score, with 80% power. 20% drop out rate assumed, 102 participants needed. Alpha level of 0.05.||||||0.05||95.0|||||Paired-t test|||||||0.05
72491297|NCT03152019|144510607|SUPERIORITY||percentages|0.77|||<|0.05|TWO_SIDED||||||Chi-squared|||||||<0.05
72491298|NCT00350142|144510617|SUPERIORITY_OR_OTHER||proportion|0.75|||||TWO_SIDED|||||||||||||
72491299|NCT00610987|144510627|SUPERIORITY_OR_OTHER||||||=|0.12|TWO_SIDED||||||t-test, 1 sided|||||||=0.12
72491300|NCT00254501|144510628|SUPERIORITY_OR_OTHER|||||||0.0757||||||Adjusted for baseline Hemoglobin A-1C.|ANCOVA|||"Null hypothesis is mean change in usual care group equals mean change in Empower group.~Power calculation required 150 per group assuming 25% would withdraw prior to 12 months."||||0.0757
72491301|NCT00254501|144510629|SUPERIORITY_OR_OTHER|||||||0.44|||||||ANCOVA|||Comparison of change in LDL from baseline to 12 months between groups.||||0.44
72491302|NCT00254501|144510629|SUPERIORITY_OR_OTHER|||||||0.16|||||||ANCOVA|||Comparison of change in HDL from baseline to 12 months between groups.||||0.16
72491303|NCT00254501|144510629|SUPERIORITY_OR_OTHER|||||||0.14|||||||ANCOVA|||Comparison of change in total cholesterol from baseline to 12 months between groups.||||0.14
72491304|NCT00254501|144510629|SUPERIORITY_OR_OTHER|||||||0.92|||||||ANCOVA|||Comparison of change in triglycerides from baseline to 12 months between groups.||||0.92
72491305|NCT00254501|144510630|SUPERIORITY_OR_OTHER|||||||0.3856|||||||Wilcoxon (Mann-Whitney)|||Comparison of change in cost of total health care from baseline to 12 months between groups. Analyses not adjusted for other variables.||||.3856
72491306|NCT00254501|144510630|SUPERIORITY_OR_OTHER|||||||0.6413|||||||Wilcoxon (Mann-Whitney)|||Comparison of change in cost of diabetes medications from baseline to 12 months between groups. Analyses not adjusted for other variables.||||.6413
72491307|NCT00254501|144510630|SUPERIORITY_OR_OTHER|||||||0.4303|||||||Wilcoxon (Mann-Whitney)|||Analyses not adjusted for other variables.||||.4303
72491308|NCT00254501|144510631|SUPERIORITY_OR_OTHER|||||||0.785|||||||ANCOVA|||Comparison of change in Diabetes Empowerment Scale from baseline to 12 months between groups.||||0.785
72491309|NCT00254501|144510631|SUPERIORITY_OR_OTHER|||||||0.302|||||||ANCOVA|||Comparison of change in Adherence Starts with Knowledge (ASK-20) from baseline to 12 months between groups.||||0.302
72491310|NCT00254501|144510631|SUPERIORITY_OR_OTHER|||||||0.0024|||||||ANCOVA|||Comparison of change in Understanding of Diabetes from baseline to 12 months between groups.||||0.0024
72491311|NCT02484911|144510665|SUPERIORITY_OR_OTHER|||||||0.397|||||||Chi-squared|||||||0.397
72491312|NCT02484911|144510666|SUPERIORITY_OR_OTHER|||||||1|||||||Chi-squared|||||||1.0
72491313|NCT02484911|144510668|SUPERIORITY_OR_OTHER|||||||0.397|||||||Chi-squared|||||||0.397
72491314|NCT02484911|144510669|SUPERIORITY_OR_OTHER|||||||0.02|||||||Chi-squared|||||||0.02
72624757|NCT01346592|144778965|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (H1N1 strain)|16.0|||||TWO_SIDED|95.0|12.6|20.1||||||No risk subjects.||20.1|12.6|
72491315|NCT02484911|144510670|SUPERIORITY_OR_OTHER|||||||1|||||||Chi-squared|||||||1.0
72491316|NCT02484911|144510671|SUPERIORITY_OR_OTHER|||||||0.005|||||||Chi-squared|||||||0.005
72491317|NCT02484911|144510673|SUPERIORITY_OR_OTHER|||||||1|||||||Chi-squared|||||||1.0
72491318|NCT02484911|144510674|SUPERIORITY_OR_OTHER|||||||0.283|||||||Chi-squared|||||||0.283
72491319|NCT02484911|144510675|SUPERIORITY_OR_OTHER|||||||1|||||||Chi-squared|||||||1.0
72491320|NCT02484911|144510676|SUPERIORITY_OR_OTHER|||||||0.246|||||||Chi-squared|||||||0.246
72491321|NCT04129528|144510678|SUPERIORITY||Ratio of geometric means CFZ533/placebo|1.173||||0.1817|TWO_SIDED|80.0|0.94|1.47||one-sided P-value|Mixed model repeated measure analysis|||||1.47|0.94|0.1817
72491322|NCT01964352|144510697|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.331|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001|TWO_SIDED|95.0|0.293|0.369|||Mixed Effects Model for Repeated Measure|||||0.369|0.293|<0.0001
72491323|NCT01964352|144510697|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.111|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001|TWO_SIDED|95.0|0.075|0.148|||Mixed Effects Model for Repeated Measure|||||0.148|0.075|<0.0001
72404943|NCT01675882|144317174|SUPERIORITY||Difference in LS mean|8.9||||0.8702|TWO_SIDED|95.0|-65.9|189.96||P-value was based on type III sum of squares from an ANCOVA model on log transformed values for the peanut protein eliciting dose at Month 12, including treatment group, baseline eliciting dose, age-strata and country as covariates.|ANCOVA|||The LS mean for any given treatment group is the estimated mean peanut protein eliciting dose for a participant in that treatment group with the mean value for all baseline covariates in the analysis set.||189.96|-65.90|0.8702
72404944|NCT01675882|144317174|SUPERIORITY||Difference in LS mean|158.9||||0.063|TWO_SIDED|95.0|-5.5|562.31||P-value was based on type III sum of squares from an ANCOVA model on log transformed values for the peanut protein eliciting dose at Month 12, including treatment group, baseline eliciting dose, age-strata and country as covariates.|ANCOVA|||The LS mean for any given treatment group is the estimated mean peanut protein eliciting dose for a participant in that treatment group with the mean value for all baseline covariates in the analysis set.||562.31|-5.50|0.0630
72404945|NCT01675882|144317175|SUPERIORITY||Difference in LS mean|-80.2||||0.6776|TWO_SIDED|95.0|-237.22|782.24||P-value was based on type III sum of squares from an ANCOVA model on log transformed values for the peanut protein eliciting dose at Month 12, including treatment group, baseline eliciting dose, age-strata and country as covariates.|ANCOVA|||The LS mean for any given treatment group is the estimated mean peanut protein eliciting dose for a participant in that treatment group with the mean value for all baseline covariates in the analysis set.||782.24|-237.22|0.6776
72404946|NCT01675882|144317175|SUPERIORITY||Difference in LS mean|158.8||||0.5068|TWO_SIDED|95.0|-166.1|1478.83||P-value was based on type III sum of squares from an ANCOVA model on log transformed values for the peanut protein eliciting dose at Month 12, including treatment group, baseline eliciting dose, age-strata and country as covariates.|ANCOVA|||The LS mean for any given treatment group is the estimated mean peanut protein eliciting dose for a participant in that treatment group with the mean value for all baseline covariates in the analysis set.||1478.83|-166.10|0.5068
72624758|NCT01346592|144778965|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (H3N2 strain)|7.0|||||TWO_SIDED|95.0|4.6|9.8||||||No risk subjects||9.8|4.6|
72404947|NCT01675882|144317175|SUPERIORITY||Difference in LS mean|53.8||||0.7972|TWO_SIDED|95.0|-193.9|1085.38||P-value was based on type III sum of squares from an ANCOVA model on log transformed values for the peanut protein eliciting dose at Month 12, including treatment group, baseline eliciting dose, age-strata and country as covariates.|ANCOVA|||The LS mean for any given treatment group is the estimated mean peanut protein eliciting dose for a participant in that treatment group with the mean value for all baseline covariates in the analysis set.||1085.38|-193.90|0.7972
72404948|NCT01675882|144317176|SUPERIORITY||Difference in LS mean|120.0||||0.0444|TWO_SIDED|95.0|2.3|321.8||P-value was based on type III sum of squares from an ANCOVA model on log transformed values for cumulative reactive dose at Month 12, including treatment group, baseline cumulative reactive dose, age-strata and country as covariates.|ANCOVA|||The LS mean for any given treatment group was the estimated mean peanut protein cumulative reactive dose for a participant in that treatment group with the mean value for all baseline covariates in the analysis set.||321.80|2.30|0.0444
72404949|NCT01675882|144317176|SUPERIORITY||Difference in LS mean|147.6||||0.0175|TWO_SIDED|95.0|19.67|365.51||P-value was based on type III sum of squares from an ANCOVA model on log transformed values for the cumulative reactive dose at Month 12, including treatment group, baseline cumulative reactive dose, age-strata and country as covariates.|ANCOVA|||The LS mean for any given treatment group was the estimated mean peanut protein cumulative reactive dose for a participant in that treatment group with the mean value for all baseline covariates in the analysis set.||365.51|19.67|0.0175
72491324|NCT01964352|144510697|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001|TWO_SIDED|95.0|0.262|0.337|||Mixed Effects Model for Repeated Measure|||||0.337|0.262|<0.0001
72491325|NCT01964352|144510697|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.08|STANDARD_ERROR_OF_MEAN|0.018|<|0.0001|TWO_SIDED|95.0|0.044|0.116|||Mixed Effects Model for Repeated Measure|||||0.116|0.044|<0.0001
72491326|NCT01964352|144510697|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.219|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001|TWO_SIDED|95.0|0.181|0.258|||Mixed Effects Model for Repeated Measure|||||0.258|0.181|<0.0001
72491327|NCT01964352|144510697|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.031|STANDARD_ERROR_OF_MEAN|0.018||0.0872|TWO_SIDED|95.0|-0.005|0.067|||Mixed Effects Model for Repeated Measure|||||0.067|-0.005|0.0872
72491328|NCT01964352|144510698|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.162|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001|TWO_SIDED|95.0|0.0124|0.2|||Mixed Effects Model for Repeated Measure|||||0.200|0.0124|<0.0001
72491329|NCT01964352|144510698|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.028|STANDARD_ERROR_OF_MEAN|0.019||0.1381|TWO_SIDED|95.0|-0.009|0.066|||Mixed Effects Model for Repeated Measure|||||0.066|-0.009|0.1381
72491330|NCT01964352|144510698|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.15|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001|TWO_SIDED|95.0|0.113|0.188|||Mixed Effects Model for Repeated Measure|||||0.188|0.113|<0.0001
72491331|NCT01964352|144510698|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.017|STANDARD_ERROR_OF_MEAN|0.019||0.3872|TWO_SIDED|95.0|-0.021|0.054|||Mixed Effects Model for Repeated Measure|||||0.054|-0.021|0.3872
72624759|NCT01346592|144778965|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (B strain)|15.0|||||TWO_SIDED|95.0|11.9|18.3||||||No risk subjects.||18.3|11.9|
72491332|NCT01964352|144510698|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.134|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001|TWO_SIDED|95.0|0.096|0.172|||Mixed Effects Model for Repeated Measure|||||0.172|0.096|<0.0001
72491333|NCT01964352|144510698|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.012|STANDARD_ERROR_OF_MEAN|0.019||0.5333|TWO_SIDED|95.0|-0.025|0.049|||Mixed Effects Model for Repeated Measure|||||0.049|-0.025|0.5333
72491334|NCT01964352|144510699|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.894|STANDARD_ERROR_OF_MEAN|1.024|<|0.0001|TWO_SIDED|95.0|-6.904|-2.884|||Mixed Effects Model for Repeated Measure|||||-2.884|-6.904|<0.0001
72491335|NCT01964352|144510699|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.493|STANDARD_ERROR_OF_MEAN|1.009||0.0136|TWO_SIDED|95.0|-4.473|-0.513|||Mixed Effects Model for Repeated Measure|||||-0.513|-4.473|0.0136
72491336|NCT01964352|144510699|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.122|STANDARD_ERROR_OF_MEAN|1.023|<|0.0001|TWO_SIDED|95.0|-6.129|-2.114|||Mixed Effects Model for Repeated Measure|||||-2.114|-6.129|<0.0001
72491337|NCT01964352|144510699|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.721|STANDARD_ERROR_OF_MEAN|1.008||0.088|TWO_SIDED|95.0|-3.698|0.256|||Mixed Effects Model for Repeated Measure|||||0.256|-3.698|0.0880
72569270|NCT00444457|144669736|NON_INFERIORITY_OR_EQUIVALENCE|The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.|Difference in log-transformed GM|-0.05|||||TWO_SIDED|95.0|-0.17|0.06|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Additional serotypes - serotype 1||0.06|-0.17|
72491338|NCT01964352|144510699|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.401|STANDARD_ERROR_OF_MEAN|1.029||0.0198|TWO_SIDED|95.0|-4.419|-0.382|||Mixed Effects Model for Repeated Measure|||||-0.382|-4.419|0.0198
72491339|NCT01964352|144510699|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.772|STANDARD_ERROR_OF_MEAN|1.003||0.4415|TWO_SIDED|95.0|-2.741|1.196|||Mixed Effects Model for Repeated Measure|||||1.196|-2.741|0.4415
72491340|NCT01964352|144510700|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.22|STANDARD_ERROR_OF_MEAN|0.032|<|0.0001|TWO_SIDED|95.0|0.157|0.282|||Mixed Effects Model for Repeated Measure|||||0.282|0.157|<0.0001
72491341|NCT01964352|144510700|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.021|STANDARD_ERROR_OF_MEAN|0.032||0.5052|TWO_SIDED|95.0|-0.041|0.084|||Mixed Effects Model for Repeated Measure|||||0.084|-0.041|0.5052
72491342|NCT01964352|144510700|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.208|STANDARD_ERROR_OF_MEAN|0.032|<|0.0001|TWO_SIDED|95.0|0.146|0.271|||Mixed Effects Model for Repeated Measure|||||0.271|0.146|<0.0001
72491343|NCT01964352|144510700|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.032||0.7566|TWO_SIDED|95.0|-0.052|0.072|||Mixed Effects Model for Repeated Measure|||||0.072|-0.052|0.7566
72491344|NCT01964352|144510700|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.198|STANDARD_ERROR_OF_MEAN|0.032|<|0.0001|TWO_SIDED|95.0|0.136|0.261|||Mixed Effects Model for Repeated Measure|||||0.261|0.136|<0.0001
72491345|NCT01964352|144510700|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.011|STANDARD_ERROR_OF_MEAN|0.032||0.7199|TWO_SIDED|95.0|-0.051|0.073|||Mixed Effects Model for Repeated Measure|||||0.073|-0.051|0.7199
72491346|NCT01964352|144510701|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.052|STANDARD_ERROR_OF_MEAN|0.273|<|0.0001|TWO_SIDED|95.0|1.516|2.588|||Mixed Effects Model for Repeated Measure|||||2.588|1.516|<0.0001
72491347|NCT01964352|144510701|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.607|STANDARD_ERROR_OF_MEAN|0.27||0.0246|TWO_SIDED|95.0|0.078|1.137|||Mixed Effects Model for Repeated Measure|||||1.137|0.078|0.0246
72491348|NCT01964352|144510701|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.952|STANDARD_ERROR_OF_MEAN|0.272|<|0.0001|TWO_SIDED|95.0|1.417|2.487|||Mixed Effects Model for Repeated Measure|||||2.487|1.417|<0.0001
72491349|NCT01964352|144510701|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.507|STANDARD_ERROR_OF_MEAN|0.269||0.0599|TWO_SIDED|95.0|-0.021|1.035|||Mixed Effects Model for Repeated Measure|||||1.035|-0.021|0.0599
72491350|NCT01964352|144510701|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.445|STANDARD_ERROR_OF_MEAN|0.274|<|0.0001|TWO_SIDED|95.0|0.907|1.983|||Mixed Effects Model for Repeated Measure|||||1.983|0.907|<0.0001
72491351|NCT01964352|144510701|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.268||0.7081|TWO_SIDED|95.0|-0.425|0.626|||Mixed Effects Model for Repeated Measure|||||0.626|-0.425|0.7081
72491352|NCT01964352|144510702|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.457|STANDARD_ERROR_OF_MEAN|0.034|<|0.0001|TWO_SIDED|95.0|0.39|0.524|||Mixed Effects Model for Repeated Measure|||||0.524|0.390|<0.0001
72491353|NCT01964352|144510702|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.16|STANDARD_ERROR_OF_MEAN|0.033|<|0.0001|TWO_SIDED|95.0|0.095|0.225|||Mixed Effects Model for Repeated Measure|||||0.225|0.095|<0.0001
72491354|NCT01964352|144510702|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.398|STANDARD_ERROR_OF_MEAN|0.034|<|0.0001|TWO_SIDED|95.0|0.331|0.465|||Mixed Effects Model for Repeated Measure|||||0.465|0.331|<0.0001
72491355|NCT01964352|144510702|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.101|STANDARD_ERROR_OF_MEAN|0.033||0.0023|TWO_SIDED|95.0|0.036|0.165|||Mixed Effects Model for Repeated Measure|||||0.165|0.036|0.0023
72491356|NCT01964352|144510702|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.297|STANDARD_ERROR_OF_MEAN|0.035|<|0.0001|TWO_SIDED|95.0|0.229|0.365|||Mixed Effects Model for Repeated Measure|||||0.365|0.229|<0.0001
72491357|NCT01964352|144510702|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.059|STANDARD_ERROR_OF_MEAN|0.033||0.0701|TWO_SIDED|95.0|-0.005|0.123|||Mixed Effects Model for Repeated Measure|||||0.123|-0.005|0.0701
72491358|NCT03787472|144510703|NON_INFERIORITY|The non-inferiority of the Test lens relative to the Control will be concluded if the lower confidence limit of LSM difference is above the non-inferiority margin -5.|Least-Square Mean Difference|0.5|STANDARD_ERROR_OF_MEAN|2.98|||TWO_SIDED|95.0|-5.5|6.6|||Linear Mixed Model|The Kenward and Roger method was used for the calculation of the denominator of degrees of freedom.|Mean difference was calculated as Test - Control|||6.6|-5.5|
72491359|NCT03787472|144510704|NON_INFERIORITY|The non-inferiority of the Test lens relative to the Control will be concluded if the upper confidence limit of LSM difference is below the non-inferiority margin 0.05 logMAR.|Least-Square Mean Difference|0.008|STANDARD_ERROR_OF_MEAN|0.0166|||TWO_SIDED|95.0|-0.025|0.041|||Linear Mixed Model||Mean difference was calculated as Test - Control|Distance Standard High Contrast Bright||0.041|-0.025|
72491360|NCT03787472|144510704|NON_INFERIORITY|The non-inferiority of the Test lens relative to the Control will be concluded if the upper confidence limit of LSM difference is below the non-inferiority margin 0.05 logMAR.|Least-Square Mean Difference|-0.012|STANDARD_ERROR_OF_MEAN|0.0155|||TWO_SIDED|95.0|-0.043|0.019|||Linear Mixed Model||Mean difference was calculated as Test - Control|Intermediate Standard High Contrast Bright||0.019|-0.043|
72491361|NCT03787472|144510704|NON_INFERIORITY|The non-inferiority of the Test lens relative to the Control will be concluded if the upper confidence limit of LSM difference is below the non-inferiority margin 0.05 logMAR.|Least-Square Mean Difference|0.003|STANDARD_ERROR_OF_MEAN|0.0169|||TWO_SIDED|95.0|-0.03|0.037|||Linear Mixed Model||Mean difference was calculated as Test - Control|Near Standard High Contrast Bright||0.037|-0.030|
72624760|NCT01346592|144778965|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (H1N1 strain)|-2.0|||||TWO_SIDED|95.0|-28.5|20.2||||||At risk subjects.||20.2|-28.5|
72491362|NCT00477165|144510705|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.91||||0.59|TWO_SIDED|95.0|0.687|1.196||p\<0.05 for statistical significance|t-test, 2 sided||Repeated-measures logistic regression model, assuming the citalopram effect builds linearly over time starting at week 3.|Null hypothesis: number of patients achieving adequate relief is the same in both Citalopram and Placebo groups||1.196|0.687|0.59
72491363|NCT00105443|144510709|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.6931||||0.00583||95.0|0.5549|0.8658||According to the pre-specified O'Brien-Fleming alpha spending function, the alpha value for this second interim analysis was 0.0073 (corresponding to a nominal value of 0.0077 after taking into account the first interim analysis).|Log Rank||This is the sorafenib to placebo hazard ratio.|"The 2 arms were compared using a 1-sided log-rank test with an overall alpha of 0.02 stratified by region, ECOG PS and tumor burden. In addition to the final analysis at the end of the study, 2 formal interim analyses of overall survival were planned. An alpha spending function was used to ensure that the false positive rate is less than or equal to 0.02 (1-sided). The study was stopped at the second interim analysis, the results of which are reported here."||0.8658|0.5549|0.00583
72491364|NCT00105443|144510710|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.0764||||0.7676||95.0|0.8837|1.311|||Log Rank||This is the sorafenib to placebo hazard ratio.|"The 2 arms were compared using a 1-sided log-rank test with an overall alpha of 0.005 stratified by region, ECOG PS and tumor burden. This was a co-primary endpoint with overall survival. No alpha-spending adjustments were necessary as it was only to be analyzed at the end of study."||1.3110|0.8837|0.7676
72491365|NCT00105443|144510711|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.5764||||7e-06||95.0|0.4484|0.741|||Log Rank||This is the sorafenib to placebo hazard ratio.|"In the analysis of TTP, based on independent radiological review performed to review data up to 12 May 2006, the 2 treatment groups were compared using a 1-sided log rank test with an alpha of 0.025, stratified by region, ECOG PS, and tumor burden."||0.7410|0.4484|0.000007
72491366|NCT00105443|144510712|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-11.95||||0.001641||95.0|-19.56|-4.35|||Cochran-Mantel-Haenszel||Sorafenib minus placebo difference|"Disease control rates were compared between treatment groups using the Cochran Mantel Haenszel (CMH) test with a 1-sided alpha of 0.025, adjusting for region, ECOG PS, and tumor burden."||-4.35|-19.56|0.001641
72491367|NCT01157078|144510719|SUPERIORITY_OR_OTHER||LS mean|-1.0|STANDARD_ERROR_OF_MEAN|1.08||0.349|TWO_SIDED|95.0|-3.14|1.11||The adjusted p-value protects the overall family-wise error rate by taking into account the multiple comparisons between the TC-5214 doses for both the primary efficacy variable (MADRS) and the key secondary efficacy variable (SDS).|MMRM|||Mixed model repeated measures (MMRM) includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization MADRS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||1.11|-3.14|0.349
72491368|NCT01157078|144510720|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.2|STANDARD_ERROR_OF_MEAN|0.29||0.444|TWO_SIDED|95.0|0.75|1.92|||Regression, Logistic||TC-5214 is the numerator in the OR, OR\>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization MADRS total score as a covariate.||1.92|0.75|0.444
72491369|NCT01157078|144510721|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.52|STANDARD_ERROR_OF_MEAN|0.42||0.13|TWO_SIDED|95.0|0.88|2.61|||Regression, Logistic||TC-5214 is the numerator in the OR, OR\>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization MADRS total score as a covariate.||2.61|0.88|0.130
72491370|NCT01157078|144510722|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.75|STANDARD_ERROR_OF_MEAN|0.96||0.307|TWO_SIDED|95.0|0.6|5.14|||Regression, Logistic||TC-5214 is the numerator in the OR, OR\>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization MADRS total score as a covariate.||5.14|0.60|0.307
72491371|NCT01157078|144510723|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.44|STANDARD_ERROR_OF_MEAN|0.52||0.313|TWO_SIDED|95.0|0.71|2.94|||Regression, Logistic||TC-5214 is the numerator in the OR, OR\>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization MADRS total score as a covariate.||2.94|0.71|0.313
72517269|NCT02528253|144564415|SUPERIORITY||LS Mean Ratio|0.92||||0.551|TWO_SIDED|95.0|0.71|1.2|||Negative binomial model|||Week 12: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.||1.20|0.71|0.5510
72517270|NCT02528253|144564415|SUPERIORITY||LS Mean Ratio|1.2|STANDARD_ERROR_OF_MEAN|0.18||0.2088|TWO_SIDED|95.0|0.9|1.6|||Negative binomial model|||Week 16: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.||1.60|0.90|0.2088
72517271|NCT02528253|144564415|SUPERIORITY||LS Mean Ratio|0.98|STANDARD_ERROR_OF_MEAN|0.14||0.8692|TWO_SIDED|95.0|0.73|1.3|||Negative binomial model|||Week 16: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.||1.30|0.73|0.8692
72517272|NCT02528253|144564415|SUPERIORITY||LS Mean Ratio|1.03|STANDARD_ERROR_OF_MEAN|0.14||0.8444|TWO_SIDED|95.0|0.78|1.35|||Negative binomial model|||Week 24: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.||1.35|0.78|0.8444
72517273|NCT02528253|144564415|SUPERIORITY||LS Mean Ratio|1.02|STANDARD_ERROR_OF_MEAN|0.14||0.8936|TWO_SIDED|95.0|0.78|1.34|||Negative binomial model|||Week 24: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.||1.34|0.78|0.8936
72517274|NCT02528253|144564415|SUPERIORITY||LS Mean Ratio|0.98|STANDARD_ERROR_OF_MEAN|0.14||0.8716|TWO_SIDED|95.0|0.75|1.28|||Negative binomial model|||Week 32: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.||1.28|0.75|0.8716
72517275|NCT02528253|144564415|SUPERIORITY||LS Mean Ratio|0.98|STANDARD_ERROR_OF_MEAN|0.14||0.8827|TWO_SIDED|95.0|0.75|1.29|||Negative binomial model|||Week 32: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.||1.29|0.75|0.8827
72517276|NCT02528253|144564415|SUPERIORITY||LS Mean Ratio|1.02|STANDARD_ERROR_OF_MEAN|0.14||0.8996|TWO_SIDED|95.0|0.77|1.34|||Negative binomial model|||Week 40: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.||1.34|0.77|0.8996
72624761|NCT01346592|144778965|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (H3N2 strain)|11.0|||||TWO_SIDED|95.0|-14.9|33.5||||||At risk subjects.||33.5|-14.9|
72404950|NCT01675882|144317176|SUPERIORITY||Difference in LS mean|386.0|||<|0.0001|TWO_SIDED|95.0|159.67|771.16||P-value was based on type III sum of squares from an ANCOVA model on log transformed values for the cumulative reactive dose at Month 12, including treatment group, baseline cumulative reactive dose, age-strata and country as covariates.|ANCOVA|||The LS mean for any given treatment group was the estimated mean peanut protein cumulative reactive dose for a participant in that treatment group with the mean value for all baseline covariates in the analysis set.||771.16|159.67|<0.0001
72491372|NCT01157078|144510724|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.77|STANDARD_ERROR_OF_MEAN|0.79||0.201|TWO_SIDED|95.0|0.74|4.24|||Regression, Logistic||TC-5214 is the numerator in the OR, OR\>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization MADRS total score as a covariate.||4.24|0.74|0.201
72491373|NCT01157078|144510725|SUPERIORITY_OR_OTHER||LS mean|-0.5|STANDARD_ERROR_OF_MEAN|0.82||0.552|TWO_SIDED|95.0|-2.1|1.12|||ANCOVA|||Analysis of covariance (ANCOVA) with randomization HAMD-17 total score as covariate, treatment as a fixed effect and pooled center as a random effect.||1.12|-2.10|0.552
72517277|NCT02528253|144564415|SUPERIORITY||LS Mean Ratio|0.91|STANDARD_ERROR_OF_MEAN|0.13||0.488|TWO_SIDED|95.0|0.69|1.2|||Negative binomial model|||Week 40: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.||1.20|0.69|0.4880
72517278|NCT02528253|144564415|SUPERIORITY||LS Mean Ratio|0.96|STANDARD_ERROR_OF_MEAN|0.14||0.7938|TWO_SIDED|95.0|0.73|1.27|||Negative binomial model|||Week 48: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.||1.27|0.73|0.7938
72517279|NCT02528253|144564415|SUPERIORITY||LS Mean Ratio|0.91|STANDARD_ERROR_OF_MEAN|0.13||0.5092|TWO_SIDED|95.0|0.69|1.2|||Negative binomial model|||Week 48: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.||1.20|0.69|0.5092
72517280|NCT02528253|144564415|SUPERIORITY||LS Mean Ratio|0.93|STANDARD_ERROR_OF_MEAN|0.13||0.6148|TWO_SIDED|95.0|0.71|1.22|||Negative binomial model|||Week 56: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.||1.22|0.71|0.6148
72517281|NCT02528253|144564415|SUPERIORITY||LS Mean Ratio|0.86|STANDARD_ERROR_OF_MEAN|0.12||0.2844|TWO_SIDED|95.0|0.66|1.13|||Negative binomial model|||Week 56: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.||1.13|0.66|0.2844
72517282|NCT02528253|144564417|SUPERIORITY||LS Mean Ratio|1.1|STANDARD_ERROR_OF_MEAN|0.25||0.6764|TWO_SIDED|95.0|0.7|1.73|||Negative binomial model|||Week 2: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.||1.73|0.70|0.6764
72517283|NCT02528253|144564417|SUPERIORITY||LS Mean Ratio|1.02|STANDARD_ERROR_OF_MEAN|0.23||0.9351|TWO_SIDED|95.0|0.65|1.6|||Negative binomial model|||Week 2: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.||1.60|0.65|0.9351
72517284|NCT02528253|144564417|SUPERIORITY||LS Mean Ratio|0.97|STANDARD_ERROR_OF_MEAN|0.2||0.8731|TWO_SIDED|95.0|0.64|1.46|||Negative binomial model|||Week 2: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.||1.46|0.64|0.8731
72517285|NCT02528253|144564417|SUPERIORITY||LS Mean Ratio|1.14|STANDARD_ERROR_OF_MEAN|0.24||0.537|TWO_SIDED|95.0|0.75|1.72|||Negative binomial model|||Week 2: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.||1.72|0.75|0.5370
72517286|NCT02528253|144564417|SUPERIORITY||LS Mean Ratio|1.05|STANDARD_ERROR_OF_MEAN|0.22||0.8031|TWO_SIDED|95.0|0.7|1.59|||Negative binomial model|||Week 2: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.||1.59|0.70|0.8031
72517287|NCT02528253|144564417|SUPERIORITY||LS Mean Ratio|0.94|STANDARD_ERROR_OF_MEAN|0.24||0.8192|TWO_SIDED|95.0|0.57|1.55|||Negative binomial model|||Week 4: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.||1.55|0.57|0.8192
72491374|NCT01157078|144510726|SUPERIORITY_OR_OTHER||LS mean|0.0|STANDARD_ERROR_OF_MEAN|0.14||0.803||95.0|-0.31|0.24|||MMRM|||MMRM model includes treatment, pooled center, visit, and treatment by visit interaction as explanatory variables and the randomization CGI-S total score as a covariate. Treatment, visit, and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||0.24|-0.31|0.803
72517288|NCT02528253|144564417|SUPERIORITY||LS Mean Ratio|0.89|STANDARD_ERROR_OF_MEAN|0.22||0.6345|TWO_SIDED|95.0|0.54|1.46|||Negative binomial model|||Week 4: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.||1.46|0.54|0.6345
72517289|NCT02528253|144564417|SUPERIORITY||LS Mean Ratio|0.89|STANDARD_ERROR_OF_MEAN|0.21||0.6103|TWO_SIDED|95.0|0.56|1.4|||Negative binomial model|||Week 4: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.||1.40|0.56|0.6103
72517290|NCT02528253|144564417|SUPERIORITY||LS Mean Ratio|1.06|STANDARD_ERROR_OF_MEAN|0.25||0.7949|TWO_SIDED|95.0|0.67|1.67|||Negative binomial model|||Week 4: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.||1.67|0.67|0.7949
72517291|NCT02528253|144564417|SUPERIORITY||LS Mean Ratio|1.0|STANDARD_ERROR_OF_MEAN|0.23||0.992|TWO_SIDED|95.0|0.63|1.57|||Negative binomial model|||Week 4: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.||1.57|0.63|0.9920
72517292|NCT02528253|144564417|SUPERIORITY||LS Mean Ratio|0.96|STANDARD_ERROR_OF_MEAN|0.27||0.8772|TWO_SIDED|95.0|0.55|1.67|||Negative binomial model|||Week 8: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.||1.67|0.55|0.8772
72517293|NCT02528253|144564417|SUPERIORITY||LS Mean Ratio|0.92|STANDARD_ERROR_OF_MEAN|0.26||0.7614|TWO_SIDED|95.0|0.53|1.6|||Negative binomial model|||Week 8: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.||1.60|0.53|0.7614
72517294|NCT02528253|144564417|SUPERIORITY||LS Mean Ratio|0.86|STANDARD_ERROR_OF_MEAN|0.22||0.5629|TWO_SIDED|95.0|0.52|1.43|||Negative binomial model|||Week 8: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.||1.43|0.52|0.5629
72517295|NCT02528253|144564417|SUPERIORITY||LS Mean Ratio|1.11|STANDARD_ERROR_OF_MEAN|0.29||0.6821|TWO_SIDED|95.0|0.67|1.85|||Negative binomial model|||Week 8: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.||1.85|0.67|0.6821
72404951|NCT01675882|144317177|SUPERIORITY||Difference in LS mean|-0.6||||0.251|TWO_SIDED|95.0|-1.55|0.52||P-value was based on type III sum of squares from an ANCOVA model on log transformed values for the OFC symptom scores at Month 12, including treatment group, Baseline OFC symptom scores, age-strata and country as covariates.|ANCOVA|||The LS mean for any given treatment group is the estimated mean OFC score for a participant in that treatment group with the mean value for all baseline covariates in the analysis set.||0.52|-1.55|0.2510
72404952|NCT01675882|144317177|SUPERIORITY||Difference in LS mean|-0.2||||0.682|TWO_SIDED|95.0|-1.24|1.05||P-value was based on type III sum of squares from an ANCOVA model on log transformed values for the OFC symptom scores at Month 12, including treatment group, Baseline OFC symptom scores, age-strata and country as covariates.|ANCOVA|||The LS mean for any given treatment group is the estimated mean OFC score for a participant in that treatment group with the mean value for all baseline covariates in the analysis set.||1.05|-1.24|0.6820
72517296|NCT02528253|144564417|SUPERIORITY||LS Mean Ratio|1.07|STANDARD_ERROR_OF_MEAN|0.28||0.8049|TWO_SIDED|95.0|0.64|1.77|||Negative binomial model|||Week 8: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.||1.77|0.64|0.8049
72517297|NCT02528253|144564417|SUPERIORITY||LS Mean Ratio|0.87|STANDARD_ERROR_OF_MEAN|0.27||0.6673|TWO_SIDED|95.0|0.47|1.62|||Negative binomial model|||Week 12: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.||1.62|0.47|0.6673
72517298|NCT02528253|144564417|SUPERIORITY||LS Mean Ratio|0.79|STANDARD_ERROR_OF_MEAN|0.25||0.4475|TWO_SIDED|95.0|0.43|1.46|||Negative binomial model|||Week 12: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.||1.46|0.43|0.4475
72517299|NCT02528253|144564417|SUPERIORITY||LS Mean Ratio|0.86|STANDARD_ERROR_OF_MEAN|0.25||0.5925|TWO_SIDED|95.0|0.49|1.5|||Negative binomial model|||Week 12: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.||1.50|0.49|0.5925
72517300|NCT02528253|144564417|SUPERIORITY||LS Mean Ratio|1.02|STANDARD_ERROR_OF_MEAN|0.29||0.9486|TWO_SIDED|95.0|0.58|1.79|||Negative binomial model|||Week 12: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.||1.79|0.58|0.9486
72517301|NCT02528253|144564417|SUPERIORITY||LS Mean Ratio|0.92|STANDARD_ERROR_OF_MEAN|0.26||0.7673|TWO_SIDED|95.0|0.52|1.61|||Negative binomial model|||Week 12: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.||1.61|0.52|0.7673
72517302|NCT02528253|144564417|SUPERIORITY||LS Mean Ratio|1.11|STANDARD_ERROR_OF_MEAN|0.39||0.7635|TWO_SIDED|95.0|0.56|2.2|||Negative binomial model|||Week 16: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.||2.20|0.56|0.7635
72517303|NCT02528253|144564417|SUPERIORITY||LS Mean Ratio|0.98|STANDARD_ERROR_OF_MEAN|0.34||0.9564|TWO_SIDED|95.0|0.5|1.94|||Negative binomial model|||Week 16: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.||1.94|0.50|0.9564
72517304|NCT02528253|144564417|SUPERIORITY||LS Mean Ratio|0.94|STANDARD_ERROR_OF_MEAN|0.3||0.8359|TWO_SIDED|95.0|0.5|1.75|||Negative binomial model|||Week 16: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.||1.75|0.50|0.8359
72517305|NCT02528253|144564417|SUPERIORITY||LS Mean Ratio|1.19|STANDARD_ERROR_OF_MEAN|0.38||0.5914|TWO_SIDED|95.0|0.64|2.21|||Negative binomial model|||Week 16: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.||2.21|0.64|0.5914
72517306|NCT02528253|144564417|SUPERIORITY||LS Mean Ratio|1.05|STANDARD_ERROR_OF_MEAN|0.33||0.8826|TWO_SIDED|95.0|0.56|1.95|||Negative binomial model|||Week 16: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.||1.95|0.56|0.8826
72517307|NCT02528253|144564426|SUPERIORITY||LS Mean Difference|7.02|STANDARD_ERROR_OF_MEAN|2.01||0.0005|TWO_SIDED|95.0|3.07|10.97|||ANCOVA|||TSQM Effectiveness; Week 16: p-value was computed using ANCOVA with covariates of baseline average LBPI score, treatment, and study site as a random effect.||10.97|3.07|0.0005
72517308|NCT02528253|144564426|SUPERIORITY||LS Mean Difference|6.21|STANDARD_ERROR_OF_MEAN|2.01||0.0021|TWO_SIDED|95.0|2.26|10.15|||ANCOVA|||TSQM Effectiveness; Week 16: p-value was computed using ANCOVA with covariates of baseline average LBPI score, treatment, and study site as a random effect.||10.15|2.26|0.0021
72517309|NCT02528253|144564426|SUPERIORITY||LS Mean Difference|4.72|STANDARD_ERROR_OF_MEAN|1.89||0.0125|TWO_SIDED|95.0|1.02|8.42|||ANCOVA|||TSQM Effectiveness; Week 16: p-value was computed using ANCOVA with covariates of baseline average LBPI score, treatment, and study site as a random effect.||8.42|1.02|0.0125
72517310|NCT02528253|144564426|SUPERIORITY||LS Mean Difference|2.31|STANDARD_ERROR_OF_MEAN|1.87||0.2176|TWO_SIDED|95.0|-1.36|5.97|||ANCOVA|||TSQM Effectiveness; Week 16: p-value was computed using ANCOVA with covariates of baseline average LBPI score, treatment, and study site as a random effect.||5.97|-1.36|0.2176
72517311|NCT02528253|144564426|SUPERIORITY||LS Mean Difference|1.49|STANDARD_ERROR_OF_MEAN|1.86||0.4235|TWO_SIDED|95.0|-2.16|5.14|||ANCOVA|||TSQM Effectiveness; Week 16: p-value was computed using ANCOVA with covariates of baseline average LBPI score, treatment, and study site as a random effect.||5.14|-2.16|0.4235
72517312|NCT02528253|144564426|SUPERIORITY||LS Mean Difference|12.3|STANDARD_ERROR_OF_MEAN|4.96||0.0143|TWO_SIDED|95.0|2.5|22.11|||ANCOVA|||TSQM Side Effects; Week 16: p-value was computed using ANCOVA with covariates of baseline average LBPI score, treatment, and study site as a random effect.||22.11|2.50|0.0143
72517313|NCT02528253|144564426|SUPERIORITY||LS Mean Difference|12.55|STANDARD_ERROR_OF_MEAN|4.96||0.0124|TWO_SIDED|95.0|2.76|22.35|||ANCOVA|||TSQM Side Effects; Week 16: p-value was computed using ANCOVA with covariates of baseline average LBPI score, treatment, and study site as a random effect.||22.35|2.76|0.0124
72517314|NCT02528253|144564426|SUPERIORITY||LS Mean Difference|3.88|STANDARD_ERROR_OF_MEAN|4.29||0.3675|TWO_SIDED|95.0|-4.6|12.36|||ANCOVA|||TSQM Side Effects; Week 16: p-value was computed using ANCOVA with covariates of baseline average LBPI score, treatment, and study site as a random effect.||12.36|-4.60|0.3675
72517315|NCT02528253|144564426|SUPERIORITY||LS Mean Difference|8.42|STANDARD_ERROR_OF_MEAN|3.89||0.0319|TWO_SIDED|95.0|0.74|16.11|||ANCOVA|||TSQM Side Effects; Week 16: p-value was computed using ANCOVA with covariates of baseline average LBPI score, treatment, and study site as a random effect.||16.11|0.74|0.0319
72569271|NCT00444457|144669736|NON_INFERIORITY_OR_EQUIVALENCE|The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.|Difference in log-transformed GM|-0.09|||||TWO_SIDED|95.0|-0.19|0.02|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Additional serotypes - serotype 3||0.02|-0.19|
72569272|NCT00444457|144669736|NON_INFERIORITY_OR_EQUIVALENCE|The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.|Difference in log-transformed GM|-0.18|||||TWO_SIDED|95.0|-0.28|-0.07|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Additional serotypes - serotype 3||-0.07|-0.28|
72404953|NCT01675882|144317177|SUPERIORITY||Difference in LS mean|0.8||||0.2117|TWO_SIDED|95.0|-0.42|2.47||P-value was based on type III sum of squares from an ANCOVA model on log transformed values for the OFC symptom scores at Month 12, including treatment group, Baseline OFC symptom scores, age-strata and country as covariates.|ANCOVA|||The LS mean for any given treatment group is the estimated mean OFC score for a participant in that treatment group with the mean value for all baseline covariates in the analysis set.||2.47|-0.42|0.2117
72404954|NCT01675882|144317179|SUPERIORITY||Difference in LS mean|17.4||||0.0337|TWO_SIDED|95.0|1.17|38.82||P-value was based on type III sum of squares from an ANCOVA model on log transformed values for the immunological marker at Month 12, including treatment group, Baseline marker, age-strata and country as covariates.|ANCOVA|||The LS mean for any given treatment group was the estimated mean for a participant in that treatment group with the mean value for all Baseline covariates in the analysis set.||38.82|1.17|0.0337
72404955|NCT01675882|144317179|SUPERIORITY||Difference in LS mean|26.2||||0.002|TWO_SIDED|95.0|8.38|49.45||P-value was based on type III sum of squares from an ANCOVA model on log transformed values for the immunological marker at Month 12, including treatment group, Baseline marker, age-strata and country as covariates.|ANCOVA|||The LS mean for any given treatment group was the estimated mean for a participant in that treatment group with the mean value for all Baseline covariates in the analysis set.||49.45|8.38|0.0020
72404956|NCT01675882|144317179|SUPERIORITY||Difference in LS mean|20.0||||0.012|TWO_SIDED|95.0|3.85|40.91||P-value was based on type III sum of squares from an ANCOVA model on log transformed values for the immunological marker at Month 12, including treatment group, Baseline marker, age-strata and country as covariates.|ANCOVA|||The LS mean for any given treatment group was the estimated mean for a participant in that treatment group with the mean value for all Baseline covariates in the analysis set.||40.91|3.85|0.0120
72491375|NCT01157078|144510727|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.2|STANDARD_ERROR_OF_MEAN|0.28||0.44|TWO_SIDED|95.0|0.75|1.91|||Regression, Logistic||TC-5214 is the numerator in the OR, OR\>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization Clinical Global Impression Severity (CGI-S) as a covariate.||1.91|0.75|0.440
72491376|NCT01157078|144510728|SUPERIORITY_OR_OTHER||LS mean|0.2|STANDARD_ERROR_OF_MEAN|0.55||0.768|TWO_SIDED|95.0|-0.91|1.23||Analysis for change in MADRS total score from randomization to Week 9.|MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization MADRS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||1.23|-0.91|0.768
72569273|NCT00444457|144669736|NON_INFERIORITY_OR_EQUIVALENCE|The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.|Difference in log-transformed GM|-0.09|||||TWO_SIDED|95.0|-0.19|0.02|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Additional serotypes - serotype 3||0.02|-0.19|
72624762|NCT01346592|144778965|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (B strain)|10.0|||||TWO_SIDED|95.0|-14.0|29.3||||||At risk subjects.||29.3|-14|
72404957|NCT01675882|144317183|SUPERIORITY||Difference in LS mean|1.2|||<|0.0001|TWO_SIDED|95.0|0.72|1.9||P-value was based on type III sum of squares from an ANCOVA model on log transformed values for the immunological marker at Month 12, including treatment group, Baseline marker, age-strata and country as covariates.|ANCOVA|||The LS mean for any given treatment group was the estimated mean for a participant in that treatment group with the mean value for all baseline covariates in the analysis set.||1.90|0.72|<0.0001
72404958|NCT01675882|144317183|SUPERIORITY||Difference in LS mean|1.3|||<|0.0001|TWO_SIDED|95.0|0.79|2.01||P-value was based on type III sum of squares from an ANCOVA model on log transformed values for the immunological marker at Month 12, including treatment group, Baseline marker, age-strata and country as covariates.|ANCOVA|||The LS mean for any given treatment group was the estimated mean for a participant in that treatment group with the mean value for all baseline covariates in the analysis set.||2.01|0.79|<0.0001
72569274|NCT00444457|144669736|NON_INFERIORITY_OR_EQUIVALENCE|The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.|Difference in log-transformed GM|0.25|||||TWO_SIDED|95.0|0.13|0.37|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Additional serotypes - serotype 5||0.37|0.13|
72404959|NCT01675882|144317183|SUPERIORITY||Difference in LS mean|2.1|||<|0.0001|TWO_SIDED|95.0|1.39|3.11||P-value was based on type III sum of squares from an ANCOVA model on log transformed values for the immunological marker at Month 12, including treatment group, Baseline marker, age-strata and country as covariates.|ANCOVA|||The LS mean for any given treatment group was the estimated mean for a participant in that treatment group with the mean value for all baseline covariates in the analysis set.||3.11|1.39|<0.0001
72404960|NCT00735371|144317187|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0056||95.0|||||ANCOVA|||||||0.0056
72404961|NCT00735371|144317187|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||ANCOVA|||||||<0.0001
72404962|NCT00735371|144317187|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||ANCOVA|||||||<0.0001
72624763|NCT01346592|144778965|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (H1N1 strain)|2.0|||||TWO_SIDED|95.0|-3.8|9.5||||||No risk subjects.||9.5|-3.8|
72404963|NCT00735371|144317188|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0235||95.0|||||Cochran-Mantel-Haenszel|||||||0.0235
72404964|NCT00735371|144317188|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||Cochran-Mantel-Haenszel|||||||<0.0001
72404965|NCT00735371|144317188|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||Cochran-Mantel-Haenszel|||||||<0.0001
72404966|NCT00994448|144317190|SUPERIORITY_OR_OTHER||Mean Difference (Net)|16.3|STANDARD_ERROR_OF_MEAN|8.6||0.08|TWO_SIDED|95.0|1.8|34.3|||t-test, 2 sided|||t test for mean of days retained in the bupropion versus placebo groups||34.3|1.8|0.08
72517316|NCT02528253|144564426|SUPERIORITY||LS Mean Difference|8.67|STANDARD_ERROR_OF_MEAN|3.9||0.0276|TWO_SIDED|95.0|0.97|16.38|||ANCOVA|||TSQM Side Effects; Week 16: p-value was computed using ANCOVA with covariates of baseline average LBPI score, treatment, and study site as a random effect.||16.38|0.97|0.0276
72517317|NCT02528253|144564426|SUPERIORITY||LS Mean Difference|2.57|STANDARD_ERROR_OF_MEAN|1.38||0.0627|TWO_SIDED|95.0|-0.14|5.27|||ANCOVA|||TSQM Convenience; Week 16: p-value was computed using ANCOVA with covariates of baseline average LBPI score, treatment, and study site as a random effect.||5.27|-0.14|0.0627
72517318|NCT02528253|144564426|SUPERIORITY||LS Mean Difference|3.26|STANDARD_ERROR_OF_MEAN|1.38||0.0187|TWO_SIDED|95.0|0.54|5.97|||ANCOVA|||TSQM Convenience; Week 16: p-value was computed using ANCOVA with covariates of baseline average LBPI score, treatment, and study site as a random effect.||5.97|0.54|0.0187
72517319|NCT02528253|144564426|SUPERIORITY||LS Mean Difference|1.52|STANDARD_ERROR_OF_MEAN|1.3||0.2419|TWO_SIDED|95.0|-1.03|4.06|||ANCOVA|||TSQM Convenience; Week 16: p-value was computed using ANCOVA with covariates of baseline average LBPI score, treatment, and study site as a random effect.||4.06|-1.03|0.2419
72517320|NCT02528253|144564426|SUPERIORITY||LS Mean Difference|1.05|STANDARD_ERROR_OF_MEAN|1.28||0.4124|TWO_SIDED|95.0|-1.46|3.56|||ANCOVA|||TSQM Convenience; Week 16: p-value was computed using ANCOVA with covariates of baseline average LBPI score, treatment, and study site as a random effect.||3.56|-1.46|0.4124
72517321|NCT02528253|144564426|SUPERIORITY||LS Mean Difference|1.74|STANDARD_ERROR_OF_MEAN|1.27||0.173|TWO_SIDED|95.0|-0.76|4.24|||ANCOVA|||TSQM Convenience; Week 16: p-value was computed using ANCOVA with covariates of baseline average LBPI score, treatment, and study site as a random effect.||4.24|-0.76|0.1730
72517322|NCT02528253|144564426|SUPERIORITY||LS Mean Difference|5.42|STANDARD_ERROR_OF_MEAN|1.86||0.0037|TWO_SIDED|95.0|1.77|9.08|||ANCOVA|||TSQM Global Satisfaction; Week 16: p-value was computed using ANCOVA with covariates of baseline average LBPI score, treatment, and study site as a random effect.||9.08|1.77|0.0037
72517323|NCT02528253|144564426|SUPERIORITY||LS Mean Difference|3.74|STANDARD_ERROR_OF_MEAN|1.86||0.0449|TWO_SIDED|95.0|0.09|7.39|||ANCOVA|||TSQM Global Satisfaction; Week 16: p-value was computed using ANCOVA with covariates of baseline average LBPI score, treatment, and study site as a random effect.||7.39|0.09|0.0449
72517324|NCT02528253|144564426|SUPERIORITY||LS Mean Difference|2.22|STANDARD_ERROR_OF_MEAN|1.75||0.2038|TWO_SIDED|95.0|-1.21|5.65|||ANCOVA|||TSQM Global Satisfaction; Week 16: p-value was computed using ANCOVA with covariates of baseline average LBPI score, treatment, and study site as a random effect.||5.65|-1.21|0.2038
72517325|NCT02528253|144564426|SUPERIORITY||LS Mean Difference|3.2|STANDARD_ERROR_OF_MEAN|1.73||0.0644|TWO_SIDED|95.0|-0.19|6.59|||ANCOVA|||TSQM Global Satisfaction; Week 16: p-value was computed using ANCOVA with covariates of baseline average LBPI score, treatment, and study site as a random effect.||6.59|-0.19|0.0644
72517326|NCT02528253|144564426|SUPERIORITY||LS Mean Difference|1.52|STANDARD_ERROR_OF_MEAN|1.72||0.3775|TWO_SIDED|95.0|-1.86|4.9|||ANCOVA|||TSQM Global Satisfaction; Week 16: p-value was computed using ANCOVA with covariates of baseline average LBPI score, treatment, and study site as a random effect.||4.90|-1.86|0.3775
72517327|NCT02528253|144564426|SUPERIORITY||LS Mean Difference|1.45|STANDARD_ERROR_OF_MEAN|2.62||0.5806|TWO_SIDED|95.0|-3.7|6.6|||ANCOVA|||TSQM Effectiveness; Week 56: p-value was computed using ANCOVA with covariates of baseline average LBPI score, treatment, and study site as a random effect.||6.60|-3.70|0.5806
72517328|NCT02528253|144564426|SUPERIORITY||LS Mean Difference|1.3|STANDARD_ERROR_OF_MEAN|2.53||0.6084|TWO_SIDED|95.0|-3.68|6.27|||ANCOVA|||TSQM Effectiveness; Week 56: p-value was computed using ANCOVA with covariates of baseline average LBPI score, treatment, and study site as a random effect.||6.27|-3.68|0.6084
72517329|NCT02528253|144564426|SUPERIORITY||LS Mean Difference|2.71|STANDARD_ERROR_OF_MEAN|6.95||0.6991|TWO_SIDED|95.0|-11.56|16.99|||ANCOVA|||TSQM Side Effects; Week 56: p-value was computed using ANCOVA with covariates of baseline average LBPI score, treatment, and study site as a random effect.||16.99|-11.56|0.6991
72517330|NCT02528253|144564426|SUPERIORITY||LS Mean Difference|13.17|STANDARD_ERROR_OF_MEAN|5.6||0.0265|TWO_SIDED|95.0|1.66|24.68|||ANCOVA|||TSQM Side Effects; Week 56: p-value was computed using ANCOVA with covariates of baseline average LBPI score, treatment, and study site as a random effect.||24.68|1.66|0.0265
72517331|NCT02528253|144564426|SUPERIORITY||LS Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|1.99||0.8795|TWO_SIDED|95.0|-3.61|4.21|||ANCOVA|||TSQM Convenience; Week 56: p-value was computed using ANCOVA with covariates of baseline average LBPI score, treatment, and study site as a random effect.||4.21|-3.61|0.8795
72517332|NCT02528253|144564426|SUPERIORITY||LS Mean Difference|2.1|STANDARD_ERROR_OF_MEAN|1.92||0.2758|TWO_SIDED|95.0|-1.68|5.87|||ANCOVA|||TSQM Convenience; Week 56: p-value was computed using ANCOVA with covariates of baseline average LBPI score, treatment, and study site as a random effect.||5.87|-1.68|0.2758
72517333|NCT02528253|144564426|SUPERIORITY||LS Mean Difference|3.54|STANDARD_ERROR_OF_MEAN|2.27||0.1197|TWO_SIDED|95.0|-0.92|8.0|||ANCOVA|||TSQM Global Satisfaction; Week 56: p-value was computed using ANCOVA with covariates of baseline average LBPI score, treatment, and study site as a random effect.||8.00|-0.92|0.1197
72517334|NCT02528253|144564426|SUPERIORITY||LS Mean Difference|3.93|STANDARD_ERROR_OF_MEAN|2.19||0.0743|TWO_SIDED|95.0|-0.39|8.24|||ANCOVA|||TSQM Global Satisfaction; Week 56: p-value was computed using ANCOVA with covariates of baseline average LBPI score, treatment, and study site as a random effect.||8.24|-0.39|0.0743
72491377|NCT01157078|144510729|SUPERIORITY_OR_OTHER||LS mean|0.7|STANDARD_ERROR_OF_MEAN|0.78||0.373|TWO_SIDED|95.0|-0.84|2.24|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization MADRS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||2.24|-0.84|0.373
72491378|NCT01157078|144510730|SUPERIORITY_OR_OTHER||LS mean|-0.7|STANDARD_ERROR_OF_MEAN|0.9||0.435|TWO_SIDED|95.0|-2.47|1.07|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization MADRS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||1.07|-2.47|0.435
72491379|NCT01157078|144510731|SUPERIORITY_OR_OTHER||LS mean|-0.7|STANDARD_ERROR_OF_MEAN|0.97||0.501|TWO_SIDED|95.0|-2.56|1.25|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization MADRS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects the model; pooled center is a random effect.||1.25|-2.56|0.501
72491380|NCT01157078|144510732|SUPERIORITY_OR_OTHER||LS mean|-0.62|STANDARD_ERROR_OF_MEAN|0.771||0.424|TWO_SIDED|95.0|-2.134|0.901||The adjusted p-value protects the overall family-wise error rate by taking into account the multiple comparisons between the TC-5214 doses for both the primary efficacy variable (MADRS) and the key secondary efficacy variable (SDS).|MMRM|||MMRM model includes treatment, pooled center, visit, and treatment by visit interaction as explanatory variables and the randomization SDS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||0.901|-2.134|0.424
72491381|NCT01157078|144510733|SUPERIORITY_OR_OTHER||LS mean|-0.4|STANDARD_ERROR_OF_MEAN|0.3||0.214|TWO_SIDED|95.0|-0.96|0.22||Analysis for change in SDS work/school domain score from randomization (Week 8) to end of treatment (Week 16)|MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization SDS work/school domain score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||0.22|-0.96|0.214
72491382|NCT01157078|144510734|SUPERIORITY_OR_OTHER||LS mean|0.0|STANDARD_ERROR_OF_MEAN|0.29||0.931|TWO_SIDED|95.0|-0.59|0.54|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization SDS social life domain score. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||0.54|-0.59|0.931
72491383|NCT01157078|144510735|SUPERIORITY_OR_OTHER||LS mean|-0.1|STANDARD_ERROR_OF_MEAN|0.26||0.755|TWO_SIDED|95.0|-0.6|0.44|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization SDS family life/home responsibilities domain score. Treatment, visit and treatment by visit interaction are effects in the model; pooled center is a random effect.||0.44|-0.60|0.755
72404967|NCT00436748|144317192|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Exact|||The null hypothesis for the Darbepoetin Alfa QW group was that the correction proportion (p) ≤ 0.8 ; Th alternative hypothesis was that p \> 0.8. The correction proportion was compared with 0.8 using the exact method to test the null hypothesis at a 1-sided overall significance level of 0.025.||||<0.001
72404968|NCT00436748|144317192|SUPERIORITY_OR_OTHER_LEGACY|||||||0.293|||||||Exact|||The null hypothesis for the Darbepoetin Alfa Q2W group was that the correction proportion (p) ≤ 0.8 ; Th alternative hypothesis was that p \> 0.8. The correction proportion was compared with 0.8 using the exact method to test the null hypothesis at a 1-sided overall significance level of 0.025.||||0.293
72491384|NCT01157078|144510736|SUPERIORITY_OR_OTHER||LS mean|0.82|STANDARD_ERROR_OF_MEAN|1.789||0.646|TWO_SIDED|95.0|-2.699|4.346|||ANCOVA|||ANCOVA with randomization Q-LES-Q-SF % maximum total score as covariate, treatment as a fixed effect and pooled center as a random effect.||4.346|-2.699|0.646
72517335|NCT01357980|144564444|SUPERIORITY_OR_OTHER_LEGACY||Mean Treatment Difference|-1.54||||0.11|TWO_SIDED|95.0|-3.47|0.39||No multiplicity adjustment applied: each test conducted at a 5% significance level.|ANCOVA|||Comparison of the average Daily IEF change from baseline to DAY 84 using ANCOVA with the baseline average daily IEF value as covariate.||0.39|-3.47|0.11
72569275|NCT00444457|144669736|NON_INFERIORITY_OR_EQUIVALENCE|The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.|Difference in log-transformed GM|0.0|||||TWO_SIDED|95.0|-0.12|0.12|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Additional serotypes - serotype 5||0.12|-0.12|
72404969|NCT01610791|144317208|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||Difference in ALT from Baseline to Week 24||||<0.001
72404970|NCT01610791|144317208|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||Difference in AST from Baseline to Week 24||||<0.001
72404971|NCT01610791|144317209|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||Diffrence in total cholesterol from baseline to Week 24||||<0.001
72404972|NCT01610791|144317209|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||Difference in LDL cholesterol from baseline to Week 24||||<0.001
72517336|NCT01357980|144564444|SUPERIORITY_OR_OTHER_LEGACY||Mean Treatment Difference|-0.61||||0.07|TWO_SIDED|95.0|-1.27|0.05||No multiplicity adjustment applied: each test conducted at a 5% significance level.|ANCOVA|||Comparison of the average Daily IEF change from baseline to DAY 84 using ANCOVA with the baseline average daily IEF value as covariate.||0.05|-1.27|0.07
72404973|NCT02462967|144317236|SUPERIORITY|||||||1|||||||ANCOVA|||||||1.000
72404974|NCT02462967|144317236|SUPERIORITY|||||||1|||||||ANCOVA|||||||1.000
72517337|NCT01357980|144564445|SUPERIORITY_OR_OTHER_LEGACY||Mean Treatment Difference|219.5|||<|0.01|TWO_SIDED|95.0|69.6|369.5|||ANCOVA|||Comparison of the maximum Cystometric Capacity change from baseline to DAY 14 using ANCOVA with the baseline maximum Cystometric Capacity as covariate.||369.5|69.6|<0.01
72517338|NCT01357980|144564445|SUPERIORITY_OR_OTHER_LEGACY||Mean Treatment Difference|224.1|||<|0.01|TWO_SIDED|95.0|140.9|307.4|||ANCOVA|||Comparison of the maximum Cystometric Capacity change from baseline to DAY 14 using ANCOVA with the baseline maximum Cystometric Capacity as covariate.||307.4|140.9|<0.01
72517339|NCT01357980|144564445|SUPERIORITY_OR_OTHER_LEGACY||Mean Treatment Difference|117.0||||0.09||95.0|-20.0|254.0|||ANCOVA|||Comparison of the maximum Cystometric Capacity change from baseline to DAY 42 using ANCOVA with the baseline maximum Cystometric Capacity as covariate.||254.0|-20.0|0.09
72517340|NCT01357980|144564445|SUPERIORITY_OR_OTHER_LEGACY||Mean Treatment Difference|223.7|||<|0.01|TWO_SIDED|95.0|94.3|353.1|||ANCOVA|||Comparison of the maximum Cystometric Capacity change from baseline to DAY 42 using ANCOVA with the baseline maximum Cystometric Capacity as covariate.||353.1|94.3|<0.01
72517341|NCT01357980|144564445|SUPERIORITY_OR_OTHER_LEGACY||Mean Treatment Difference|138.5||||0.01|TWO_SIDED|95.0|34.7|242.2|||ANCOVA|||Comparison of the maximum Cystometric Capacity change from baseline to DAY 84 using ANCOVA with the baseline maximum Cystometric Capacity as covariate.||242.2|34.7|0.01
72517342|NCT01357980|144564445|SUPERIORITY_OR_OTHER_LEGACY||Mean Treatment Difference|186.3|||<|0.01|TWO_SIDED|95.0|53.2|319.4|||ANCOVA|||Comparison of the maximum Cystometric Capacity change from baseline to DAY 84 using ANCOVA with the baseline maximum Cystometric Capacity as covariate.||319.4|53.2|<0.01
72624764|NCT01346592|144778965|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (H3N2 strain)|3.0|||||TWO_SIDED|95.0|-1.8|10.0||||||No risk subjects.||10|-1.8|
72404975|NCT02462967|144317237|SUPERIORITY|||||||0.447|||||||ANCOVA|||||||0.447
72404976|NCT02462967|144317237|SUPERIORITY|||||||0.921|||||||ANCOVA|||||||0.921
72404977|NCT02462967|144317238|SUPERIORITY|||||||0.522|||||||ANCOVA|||||||0.522
72404978|NCT02462967|144317238|SUPERIORITY|||||||1|||||||ANCOVA|||||||1.000
72404979|NCT02462967|144317239|SUPERIORITY|||||||0.943|||||||ANCOVA|||||||0.943
72404980|NCT02462967|144317239|SUPERIORITY|||||||0.492|||||||ANCOVA|||||||0.492
72404981|NCT02462967|144317240|SUPERIORITY|||||||0.832|||||||ANCOVA|||||||0.832
72404982|NCT02462967|144317240|SUPERIORITY|||||||0.558|||||||ANCOVA|||||||0.558
72404983|NCT02462967|144317241|SUPERIORITY|||||||0.362|||||||ANCOVA|||||||0.362
72404984|NCT02462967|144317241|SUPERIORITY|||||||0.602|||||||ANCOVA|||||||0.602
72404985|NCT02462967|144317242|SUPERIORITY|||||||0.633|||||||Chi-squared|||||||0.633
72404986|NCT02462967|144317242|SUPERIORITY|||||||0.814|||||||Chi-squared|||||||0.814
72404987|NCT00357370|144317285|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|0.1898|||TWO_SIDED|95.0|-1.08|-0.32|||||ANCOVA was applied. No formal statistical testing was performed to compare between treatment groups.|||-0.32|-1.08|
72404988|NCT00357370|144317285|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.78|STANDARD_ERROR_OF_MEAN|0.1903|||TWO_SIDED|95.0|-1.16|-0.4|||||ANCOVA was applied. No formal statistical testing was performed to compare between treatment groups.|||-0.40|-1.16|
72404989|NCT00357370|144317286|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.44|STANDARD_ERROR_OF_MEAN|11.4753|||TWO_SIDED|95.0|-38.37|7.48|||||ANCOVA was applied. No formal statistical testing was performed to compare between treatment groups.|||7.48|-38.37|
72404990|NCT00357370|144317286|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-27.44|STANDARD_ERROR_OF_MEAN|11.4574|||TWO_SIDED|95.0|-50.33|-4.55|||||ANCOVA was applied. No formal statistical testing was performed to compare between treatment groups.|||-4.55|-50.33|
72404991|NCT00357370|144317290|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.05|STANDARD_ERROR_OF_MEAN|3.8302|||TWO_SIDED|95.0|-10.69|4.6|||||ANCOVA was applied. No formal statistical testing was performed to compare between treatment groups.|||4.60|-10.69|
72404992|NCT00357370|144317290|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.52|STANDARD_ERROR_OF_MEAN|3.8291|||TWO_SIDED|95.0|-10.17|5.12|||||ANCOVA was applied. No formal statistical testing was performed to compare between treatment groups.|||5.12|-10.17|
72404993|NCT00404352|144317298|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Log Rank|Log-rank test was stratified for controlling randomization stratification factors.||||||<0.001
72517343|NCT01357980|144564446|SUPERIORITY_OR_OTHER_LEGACY||Mean Treatment Difference|-23.8||||0.25|TWO_SIDED|95.0|-66.6|18.9|||ANCOVA|||Comparison of the maximum Detrusor Pressure change from baseline to DAY 14 using ANCOVA with the baseline Maximum Detrusor Pressure as covariate.||18.9|-66.6|0.25
72517344|NCT01357980|144564446|SUPERIORITY_OR_OTHER_LEGACY||Mean Treatment Difference|-67.1|||<|0.01|TWO_SIDED|95.0|-112.9|-21.2|||ANCOVA|||Comparison of the maximum Detrusor Pressure change from baseline to DAY 14 using ANCOVA with the baseline Maximum Detrusor Pressure as covariate.||-21.2|-112.9|<0.01
72517345|NCT01357980|144564446|SUPERIORITY_OR_OTHER_LEGACY||Mean Treatment Difference|-35.1||||0.03|TWO_SIDED|95.0|-65.6|-4.6|||ANCOVA|||Comparison of the maximum Detrusor Pressure change from baseline to DAY 42 using ANCOVA with the baseline Maximum Detrusor Pressure as covariate.||-4.6|-65.6|0.03
72517346|NCT01357980|144564446|SUPERIORITY_OR_OTHER_LEGACY||Mean Treatment Difference|-51.0||||0.01|TWO_SIDED|95.0|-89.5|-12.4|||ANCOVA|||Comparison of the maximum Detrusor Pressure change from baseline to DAY 42 using ANCOVA with the baseline Maximum Detrusor Pressure as covariate.||-12.4|-89.5|0.01
72517347|NCT01357980|144564446|SUPERIORITY_OR_OTHER_LEGACY||Mean Treatment Difference|-32.3|||<|0.01|TWO_SIDED|95.0|-53.7|-11.0|||ANCOVA|||Comparison of the maximum Detrusor Pressure change from baseline to DAY 84 using ANCOVA with the baseline Maximum Detrusor Pressure as covariate.||-11.0|-53.7|<0.01
72517348|NCT01357980|144564446|SUPERIORITY_OR_OTHER_LEGACY||Mean Treatment Difference|-45.3|||<|0.01|TWO_SIDED|95.0|-76.6|-14.1|||ANCOVA|||Comparison of the maximum Detrusor Pressure change from baseline to DAY 84 using ANCOVA with the baseline Maximum Detrusor Pressure as covariate.||-14.1|-76.6|<0.01
72517349|NCT01357980|144564447|SUPERIORITY_OR_OTHER_LEGACY||Mean Treatment Difference|1.7||||0.05||95.0|||||Satterthwaite-Welch's t-test|||Comparison of the Physician's Global Assessment score at DAY 14 using a two sided Satterthwaite-Welch's t-test for independent samples.||||0.05
72491385|NCT01157078|144510737|SUPERIORITY_OR_OTHER||LS mean|-0.1|STANDARD_ERROR_OF_MEAN|0.12||0.446|TWO_SIDED|95.0|-0.31|0.14|||ANCOVA|||An analysis of covariance (ANCOVA) with randomization Q-LES-Q-SF item 15 score as covariate, treatment as a fixed effect and pooled center as a random effect.||0.14|-0.31|0.446
72491386|NCT01157078|144510738|SUPERIORITY_OR_OTHER||LS mean|0.1|STANDARD_ERROR_OF_MEAN|0.1||0.178|TWO_SIDED|95.0|-0.06|0.33|||ANCOVA|||An analysis of covariance (ANCOVA) with randomization Q-LES-Q-SF item 16 as a fixed effect and pooled center as a random effect.||0.33|-0.06|0.178
72491387|NCT01157078|144510739|SUPERIORITY_OR_OTHER||LS Mean|-1.1|STANDARD_ERROR_OF_MEAN|1.61||0.515|TWO_SIDED|95.0|-4.22|2.12|||MMRM|||MMRM model includes treatment, pooled center, visit, and treatment by visit interaction as explanatory variables and the randomization SIS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||2.12|-4.22|0.515
72491388|NCT01157078|144510740|SUPERIORITY_OR_OTHER||LS mean|0.024|STANDARD_ERROR_OF_MEAN|0.0226||0.298|TWO_SIDED|95.0|-0.0209|0.068||Analysis for change in EQ-5D index score from randomization (Week 8) to end of treatment (Week 16)|MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization EQ-5D total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||0.0680|-0.0209|0.298
72491389|NCT01157078|144510740|SUPERIORITY_OR_OTHER||LS mean|1.6|STANDARD_ERROR_OF_MEAN|2.34||0.484|TWO_SIDED|95.0|-2.98|6.26||Analysis of change in EQ-5D VAS score from randomization (Week 8) to end of treatment (Week 16)|MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization EQ-5D VAS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||6.26|-2.98|0.484
72491390|NCT03962439|144510744|OTHER|Null-hypothesis significance testing|F-value|1.61||||0.211|TWO_SIDED|||||A priori threshold was two-sided 0.05. No adjustment for multiple comparisons.|ANCOVA|Adjusted for baseline age, sex, and education.||Repeated measures ANCOVA testing whether change in episodic memory from baseline to 16 weeks interacted with condition (Time x Condition).||||.211
72517350|NCT01357980|144564447|SUPERIORITY_OR_OTHER_LEGACY||Mean Treatment Difference|2.3|||<|0.01|||||||Satterthwaite-Welch's t-test|||Comparison of the Physician's Global Assessment score at DAY 14 using a two sided Satterthwaite-Welch's t-test for independent samples.||||<0.01
72517351|NCT01357980|144564448|SUPERIORITY_OR_OTHER_LEGACY||Mean Treatment Difference|2.3||||0.01|||||||Satterthwaite-Welch's t-test|||Comparison of the Physician's Global Assessment score at DAY 42 using a two sided Satterthwaite-Welch's t-test for independent samples.||||0.01
72517352|NCT01357980|144564448|SUPERIORITY_OR_OTHER_LEGACY||Mean Treatment Difference|1.8|||<|0.01|||||||Satterthwaite-Welch's t-test|||Comparison of the Physician's Global Assessment score at DAY 42 using a two sided Satterthwaite-Welch's t-test for independent samples.||||<0.01
72569276|NCT00444457|144669736|NON_INFERIORITY_OR_EQUIVALENCE|The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.|Difference in log-transformed GM|-0.25|||||TWO_SIDED|95.0|-0.37|-0.13|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Additional serotypes - serotype 5||-0.13|-0.37|
72624765|NCT01346592|144778965|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (B strain)|6.0|||||TWO_SIDED|95.0|1.5|12.5||||||No risk subjects.||12.5|1.5|
72491391|NCT03962439|144510746|OTHER|Null hypothesis significance testing|F-value|1.66||||0.203|TWO_SIDED|||||A priori threshold was two-sided 0.05. No adjustment for multiple comparisons.|ANCOVA|Adjusted for baseline age, sex, and education.||Repeated measures ANCOVA testing whether change in speed of processing from baseline to 16 weeks interacted with condition (Time x Condition).||||.203
72491392|NCT03962439|144510748|OTHER|Null hypothesis significance testing|F-value|0.28||||0.76|TWO_SIDED|||||A priori threshold was two-sided 0.05. No adjustment for multiple comparisons.|ANCOVA|Adjusted for baseline age, sex, and education.||Repeated measures ANCOVA testing whether change in reasoning from baseline to week 16 interacted with condition (Time x Condition).||||.760
72491393|NCT01192022|144510781|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.87|STANDARD_ERROR_OF_MEAN|1.6|<|0.001|TWO_SIDED|95.0|2.55|9.29||Logistic regression model with treatment and pooled center as factors.|Regression, Logistic|||||9.29|2.55|<0.001
72491394|NCT00781456|144510811|SUPERIORITY_OR_OTHER||Odds Ratio, log|0.02|STANDARD_ERROR_OF_MEAN|0.43||0.954|TWO_SIDED|95.0|-0.82|0.87|||Regression, Logistic|Logistic regression model with terms of treatment, weekly baseline migraine frequency, and center included in the model.|91-day Levonogestrel Oral Contraceptive versus placebo. Treatment Difference was estimated using logistic regression for the proportion of participants with \>=50% reduction in migraine frequency during the treatment period.|||0.87|-0.82|0.954
72517353|NCT01357980|144564449|SUPERIORITY_OR_OTHER_LEGACY||Mean Treatment Difference|1.9||||0.05|||||||Satterthwaite-Welch's t-test|||Comparison of the Physician's Global Assessment score at DAY 84 using a two sided Satterthwaite-Welch's t-test for independent samples.||||0.05
72517354|NCT01357980|144564449|SUPERIORITY_OR_OTHER_LEGACY||Mean Treatment Difference|2.1|||<|0.01|||||||Satterthwaite-Welch's t-test|||Comparison of the Physician's Global Assessment score at DAY 84 using a two sided Satterthwaite-Welch's t-test for independent samples.||||<0.01
72517355|NCT01357980|144564450|SUPERIORITY_OR_OTHER_LEGACY||Mean Treatment Difference|-1.13|||<|0.01|TWO_SIDED|95.0|-1.91|-0.35|||ANCOVA|||Comparison of the Quality of Life Total Summary score change from baseline to DAY 14 using ANCOVA with the baseline Quality of Life Total Summary score as covariate.||-0.35|-1.91|<0.01
72517356|NCT01357980|144564450|SUPERIORITY_OR_OTHER_LEGACY||Mean Treatment Difference|-0.18||||0.7|TWO_SIDED|95.0|-1.26|0.9|||ANCOVA|||Comparison of the Quality of Life Total Summary score change from baseline to DAY 14 using ANCOVA with the baseline Quality of Life Total Summary score as covariate.||0.90|-1.26|0.7
72517357|NCT01357980|144564450|SUPERIORITY_OR_OTHER_LEGACY||Mean Treatment Difference|-0.52||||0.3|TWO_SIDED|95.0|-1.56|0.52|||ANCOVA|||Comparison of the Quality of Life Total Summary score change from baseline to DAY 42 using ANCOVA with the baseline Quality of Life Total Summary score as covariate.||0.52|-1.56|0.3
72491395|NCT00781456|144510812|SUPERIORITY_OR_OTHER||Odds Ratio, log|0.31|STANDARD_ERROR_OF_MEAN|0.44||0.479|TWO_SIDED|95.0|-0.55|1.17||No adjustment for multiple comparisons was performed.|Regression, Logistic|Logistic regression model with terms of treatment, baseline weekly migraine frequency and center included in the model.|91-day Levonogestrel Oral Contraceptive versus placebo. Treatment Difference was estimated using logistic regression for the proportion of participants with \>=50% reduction in migraine frequency during the treatment period.|Comparison of percentage of participants with a reduction of 50% or more in migraine frequency during the first month of treatment.||1.17|-0.55|0.479
72491396|NCT00781456|144510812|SUPERIORITY_OR_OTHER||Odds Ratio, log|0.5|STANDARD_ERROR_OF_MEAN|0.44||0.256|TWO_SIDED|95.0|-0.36|1.37||No adjustment for multiple comparisons was performed.|Regression, Logistic|Logistic regression model with terms of treatment, baseline weekly migraine frequency and center included in the model.|91-day Levonogestrel Oral Contraceptive versus placebo. Treatment Difference was estimated using logistic regression for the proportion of participants with \>=50% reduction in migraine frequency during the treatment period.|Comparison of percentage of participants with a reduction of 50% or more in migraine frequency during the second month of treatment||1.37|-0.36|0.256
72491397|NCT00781456|144510812|SUPERIORITY_OR_OTHER||Odds Ratio, log|-0.14|STANDARD_ERROR_OF_MEAN|0.52||0.788|TWO_SIDED|95.0|-1.16|0.88||No adjustment for multiple comparisons was performed.|Regression, Logistic|Logistic regression model with terms of treatment, baseline weekly migraine frequency and center included in the model.|91-day Levonogestrel Oral Contraceptive versus placebo. Treatment Difference was estimated using logistic regression for the proportion of participants with \>=50% reduction in migraine frequency during the treatment period.|Comparison of percentage of participants with a reduction of 50% or more in migraine frequency during the third month of treatment.||0.88|-1.16|0.788
72491398|NCT00781456|144510813|SUPERIORITY_OR_OTHER||Odds Ratio, log|-0.19||||0.182|TWO_SIDED|95.0|-0.47|0.09|||ANCOVA|Treatment comparison was performed using an analysis of covariance model with baseline average migraine severity and center as covariates.|91-day Levonogestrel Oral Contraceptive versus placebo.|Comparison of change from Baseline in migraine severity during the 91-day treatment period.||0.09|-0.47|0.182
72491399|NCT00781456|144510813|SUPERIORITY_OR_OTHER||Odds Ratio, log|-0.04||||0.853|TWO_SIDED|95.0|-0.71|0.19|||ANCOVA|Treatment comparison was performed using an analysis of covariance model with baseline average migraine severity and center as covariates.|91-day Levonogestrel Oral Contraceptive versus placebo.|Comparison of change from Baseline in migraine severity during the first month of treatment||0.19|-0.71|0.853
72491400|NCT00781456|144510813|SUPERIORITY_OR_OTHER||Odds Ratio, log|-0.26||||0.249|TWO_SIDED|95.0|-0.71|0.19|||ANCOVA|Treatment comparison was performed using an analysis of covariance model with baseline average migraine severity and center as covariates.|91-day Levonogestrel Oral Contraceptive versus placebo.|Comparison of change from Baseline in migraine severity during the second month of treatment||0.19|-0.71|0.249
72491401|NCT00781456|144510813|SUPERIORITY_OR_OTHER||Odds Ratio, log|-0.4||||0.119|TWO_SIDED|95.0|-0.9|0.1|||ANCOVA|Treatment comparison was performed using an analysis of covariance model with baseline average migraine severity and center as covariates.|91-day Levonogestrel Oral Contraceptive versus placebo.|Comparison of change from Baseline in migraine severity during the third month of treatment||0.10|-0.90|0.119
72491402|NCT00781456|144510814|SUPERIORITY_OR_OTHER|||||||0.457|||||||Cochran-Mantel-Haenszel|||Comparison of percentage of participants requiring rescue medication during the first month of treatment.||||0.457
72491403|NCT00781456|144510814|SUPERIORITY_OR_OTHER|||||||0.361|||||||Cochran-Mantel-Haenszel|||Comparison of percentage of participants requiring rescue medication during the second month of treatment.||||0.361
72491404|NCT00781456|144510814|SUPERIORITY_OR_OTHER|||||||0.018|||||||Cochran-Mantel-Haenszel|||Comparison of percentage of participants requiring rescue medication during the third month of treatment.||||0.018
72491405|NCT00781456|144510814|SUPERIORITY_OR_OTHER|||||||0.709|||||||Cochran-Mantel-Haenszel|||Comparison of percentage of participants requiring rescue medication during the 91-day treatment period.||||0.709
72491406|NCT00783094|144510832|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|0.6||0.201|TWO_SIDED|95.0|-1.8|0.4|||ANCOVA|With effects for treatment, prior alpha blocker use (yes/no), and baseline value.|Least Squares Mean Difference = Tadalafil 2.5 mg - Placebo|||0.4|-1.8|0.201
72491407|NCT00783094|144510832|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.1|STANDARD_ERROR_OF_MEAN|0.6||0.062|TWO_SIDED|95.0|-2.2|0.1|||ANCOVA|With effects for treatment, prior alpha blocker use (yes/no) and baseline value.|Least Squares Mean Difference = Tadalafil 5 mg - Placebo.|||0.1|-2.2|0.062
72517358|NCT01357980|144564450|SUPERIORITY_OR_OTHER_LEGACY||Mean Treatment Difference|-0.48||||0.3|TWO_SIDED|95.0|-1.47|0.52|||ANCOVA|||Comparison of the Quality of Life Total Summary score change from baseline to DAY 42 using ANCOVA with the baseline Quality of Life Total Summary score as covariate.||0.52|-1.47|0.3
72404994|NCT00404352|144317298|SUPERIORITY_OR_OTHER|||||||0.008|||||||Log Rank|Log-rank test was stratified for controlling randomization stratification factors.||||||0.008
72491408|NCT00783094|144510833|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.2||0.356|TWO_SIDED|95.0|-0.7|0.2|||ANCOVA|With effects for treatment, prior alpha blocker use (yes/no) and baseline value.|Least Squares Mean Difference = Tadalafil 2.5 mg - Placebo.|||0.2|-0.7|0.356
72491409|NCT00783094|144510833|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.2||0.487|TWO_SIDED|95.0|-0.6|0.3|||ANCOVA|With effects for treatment, prior alpha blocker use (yes/no) and baseline value.|Least Squares Mean Difference = Tadalafil 5 mg - Placebo.|||0.3|-0.6|0.487
72491410|NCT00783094|144510834|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|0.4||0.228|TWO_SIDED|95.0|-1.3|0.3|||ANCOVA|With effects for treatment, prior alpha blocker use (yes/no) and baseline value.|Least Squares Mean Difference = Tadalafil 2.5 mg - Placebo|||0.3|-1.3|0.228
72517359|NCT01357980|144564450|SUPERIORITY_OR_OTHER_LEGACY||Mean Treatment Difference|-1.38|||<|0.01|TWO_SIDED|95.0|-2.02|-0.73|||ANCOVA|||Comparison of the Quality of Life Total Summary score change from baseline to DAY 84 using ANCOVA with the baseline Quality of Life Total Summary score as covariate.||-0.73|-2.02|<0.01
72517360|NCT01357980|144564450|SUPERIORITY_OR_OTHER_LEGACY||Mean Treatment Difference|-0.4||||0.4|TWO_SIDED|95.0|-1.35|0.55|||ANCOVA|||Comparison of the Quality of Life Total Summary score change from baseline to DAY 84 using ANCOVA with the baseline Quality of Life Total Summary score as covariate.||0.55|-1.35|0.4
72517361|NCT04507776|144564454|OTHER|||||||0.75|||||||t-test, 2 sided|||Year 1 Adherence: Baseline||||0.75
72404995|NCT00404352|144317298|SUPERIORITY_OR_OTHER|||||||0.009|||||||Log Rank|Log-rank test was stratified for controlling randomization stratification factors.||||||0.009
72404996|NCT00404352|144317299|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Log Rank|Log-rank test was stratified for controlling randomization stratification factors.||||||<0.001
72491411|NCT00783094|144510834|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9|STANDARD_ERROR_OF_MEAN|0.4||0.033|TWO_SIDED|95.0|-1.7|-0.1|||ANCOVA|With effects for treatment, prior alpha blocker use (yes/no) and baseline value.|Least Squares Mean Difference = Tadalafil 5 mg - Placebo.|||-0.1|-1.7|0.033
72491412|NCT00783094|144510835|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.1||0.249|TWO_SIDED|95.0|-0.4|0.1|||ANCOVA|With effects for treatment,BPH severity (moderate/severe), prior alpha blocker use (yes/no), and baseline value.|Least Squares Mean Difference = Tadalafil 2.5 mg - Placebo.|||0.1|-0.4|0.249
72491413|NCT00783094|144510835|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.1||0.022|TWO_SIDED|95.0|-0.6|0.0|||ANCOVA|With effects for treatment,BPH severity (moderate/severe), prior alpha blocker use (yes/no) and baseline value.|Least Squares Mean Difference = Tadalafil 5 mg - Placebo.|||-0.0|-0.6|0.022
72491414|NCT00783094|144510836|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.2||0.904|TWO_SIDED|95.0|-0.4|0.3|||ANCOVA|with effects for treatment,BPH severity (moderate/severe), prior alpha blocker use (yes/no), and baseline value.|Least Squares Mean Difference = Tadalafil 2.5 mg - Placebo.|||0.3|-0.4|0.904
72491415|NCT00783094|144510836|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.2||0.8|TWO_SIDED|95.0|-0.4|0.3|||ANCOVA|With effects for treatment, BPH severity(moderate/severe), prior alpha blocker use (yes/no), and baseline value.||||0.3|-0.4|0.800
72491416|NCT00783094|144510837|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.4||0.147|TWO_SIDED|95.0|-1.5|0.2|||ANCOVA|With effects for treatment, BPH severity (moderate/severe), prior alpha blocker use (yes/no), and baseline value.|Least Squares Mean Difference = Tadalafil 2.5 mg - Placebo.|||0.2|-1.5|0.147
72491417|NCT00783094|144510837|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|0.4||0.094|TWO_SIDED|95.0|-1.6|0.1|||ANCOVA|With effects for treatment, BPH severity (moderate/severe), prior alpha blocker use (yes/no), and baseline value.|Least Squares Mean Difference = Tadalafil 5 mg - Placebo.|||0.1|-1.6|0.094
72491418|NCT00783094|144510840|SUPERIORITY_OR_OTHER|||||||0.342||95.0||||P-Value for systolic blood pressure.|Wilcoxin rank-sum test|||||||0.342
72491419|NCT00783094|144510840|SUPERIORITY_OR_OTHER|||||||0.127||95.0||||P-Value for systolic blood pressure.|Wilcoxin rank sum test|||||||0.127
72491420|NCT00783094|144510840|SUPERIORITY_OR_OTHER|||||||0.705||95.0||||P-Value for diastolic blood pressure.|Wilcoxin rank-sum test|||||||0.705
72491421|NCT00783094|144510840|SUPERIORITY_OR_OTHER|||||||0.173||95.0||||P-Value for diastolic blood pressure.|Wilcoxin rank-sum test|||||||0.173
72491422|NCT00783094|144510841|SUPERIORITY_OR_OTHER|||||||0.606||95.0|||||Wilcoxin rank-sum test|||||||0.606
72491423|NCT00783094|144510841|SUPERIORITY_OR_OTHER|||||||0.149||95.0|||||Wilcoxin rank-sum test|||||||0.149
72491424|NCT00783094|144510842|SUPERIORITY_OR_OTHER|||||||0.428||95.0|||||Wilcoxin rank-sum test|||||||0.428
72491425|NCT00783094|144510842|SUPERIORITY_OR_OTHER|||||||0.426||95.0|||||Wilcoxin rank-sum test|||||||0.426
72491426|NCT00783094|144510843|SUPERIORITY_OR_OTHER|||||||0.06||95.0|||||Wilcoxin rank-sum|||||||0.060
72491427|NCT00783094|144510843|SUPERIORITY_OR_OTHER|||||||0.212||95.0|||||Wilcoxin rank-sum|||||||0.212
72491428|NCT04852848|144510865|EQUIVALENCE|In our original power calculation, we expected to randomly assign 200 individuals to the Connect2Test (n = 100) and control conditions (n = 100). Power calculations were conducted using G\*Power assuming a two-tailed test with alpha = .05, power = .80, and an estimated COVID-19 testing rate in the Connect2Test condition of 20%. With these assumptions, the minimum detectable effect size (odds ratio) is 2.46, which corresponds to a moderate Cohen's d (0.49).|Odds Ratio (OR)|1.18||||0.6298|TWO_SIDED|95.0|0.61|2.27|||Chi-squared||The control condition was the reference category (Connect2Test intervention = 1, Control = 0).|||2.27|0.61|.6298
72491429|NCT00517595|144510870|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||Log Rank|||Within Group 1 (N=48), patients with an ECOG of 0 at baseline (N=18) were compared to patients with an ECOG of 1 at baseline (N=30).||||0.02
72491430|NCT00517595|144510871|SUPERIORITY_OR_OTHER|||||||0.0041||95.0|||||Log Rank|||Within Group 1 (N=48), patients with an ECOG of 0 at baseline (N=18) were compared to patients with an ECOG of 1 at baseline (N=30).||||0.0041
72491431|NCT00876187|144510910|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) Mean Difference|-0.33|STANDARD_ERROR_OF_MEAN|0.21||0.113|TWO_SIDED|95.0|-0.74|0.08|||ANCOVA|||Treatment difference and 95 percent (%) confidence interval (CI) was based on least squares (LS) mean. Analysis of Covariance (ANCOVA) was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||0.08|-0.74|0.113
72491432|NCT00876187|144510910|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|-1.19|-0.42|||ANCOVA|||Treatment difference and 95% CI was based on LS mean. ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.42|-1.19|<0.001
72404997|NCT00404352|144317299|SUPERIORITY_OR_OTHER|||||||0.002|||||||Log Rank|Log-rank test was stratified for controlling randomization stratification factors.||||||0.002
72517362|NCT04507776|144564454|OTHER||||||<|0.05|||||||t-test, 2 sided|||Year 1 Adherence: Year 1 (Month 12)||||<0.05
72624766|NCT01346592|144778965|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (H1N1 strain)|-6.0|||||TWO_SIDED|95.0|-40.7|27.9||||||At risk subjects.||27.9|-40.7|
72404998|NCT00404352|144317299|SUPERIORITY_OR_OTHER|||||||0.774|||||||Log Rank|Log-rank test was stratified for controlling randomization stratification factors.||||||0.774
72404999|NCT00606892|144317317|SUPERIORITY_OR_OTHER||||||<|0.05||95.0||||Significant treatment or treatment-by-time interactions were followed up by post hoc comparisons of placebo vs. varenicline for time (Pre- vs. Post-Nicotine infusion) and testing block (Smoking Block vs. Negative Affect Block).|Mixed Models Analysis|||A mixed-effect repeated-measures crossover model with fixed main effect terms of treatment (placebo or varenicline) and time of measurement (Pre-Nicotine or Post-Nicotine) was utilized. Interactions between main effect terms were also analyzed.||||<0.05
72405000|NCT00606892|144317318|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|17.0|STANDARD_DEVIATION|40.0|<|0.3|TWO_SIDED|95.0|||||ANOVA|F(1,10)=1.1||||||<0.3
72491433|NCT00876187|144510910|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.93|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|-1.31|-0.54|||ANCOVA|||Treatment difference and 95% CI was based on LS mean. ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.54|-1.31|<0.001
72491434|NCT00876187|144510910|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.08|STANDARD_ERROR_OF_MEAN|0.2||0.688|TWO_SIDED|95.0|-0.31|0.47|||ANCOVA|||Treatment difference and 95% CI was based on LS mean. ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||0.47|-0.31|0.688
72491435|NCT00876187|144510910|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.39|STANDARD_ERROR_OF_MEAN|0.19||0.035|TWO_SIDED|95.0|-0.76|-0.03|||ANCOVA|||Treatment difference and 95% CI was based on LS mean. ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.03|-0.76|0.035
72491436|NCT00876187|144510910|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.51|STANDARD_ERROR_OF_MEAN|0.19||0.006|TWO_SIDED|95.0|-0.88|-0.15|||ANCOVA|||Treatment difference and 95% CI was based on LS mean. ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.15|-0.88|0.006
72491437|NCT00876187|144510913|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.18||0.221|TWO_SIDED|95.0|-0.57|0.13|||ANCOVA|||Change at Week 2: Treatment difference and 95% CI was based on LS mean. ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||0.13|-0.57|0.221
72491438|NCT00876187|144510913|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.57|STANDARD_ERROR_OF_MEAN|0.17|<|0.001|TWO_SIDED|95.0|-0.9|-0.24|||ANCOVA|||Change at Week 2: Treatment difference and 95% CI was based on LS mean. ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.24|-0.90|<0.001
72491439|NCT00876187|144510913|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.37|STANDARD_ERROR_OF_MEAN|0.17||0.027|TWO_SIDED|95.0|-0.7|-0.04|||ANCOVA|||Change at Week 2: Treatment difference and 95% CI was based on LS mean. ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.04|-0.70|0.027
72491440|NCT00876187|144510913|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.29|STANDARD_ERROR_OF_MEAN|0.17||0.082|TWO_SIDED|95.0|-0.04|0.62|||ANCOVA|||Change at Week 2: Treatment difference and 95% CI was based on LS mean. ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||0.62|-0.04|0.082
72491441|NCT00876187|144510913|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.16||0.703|TWO_SIDED|95.0|-0.37|0.25|||ANCOVA|||Change at Week 2: Treatment difference and 95% CI was based on LS mean. ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||0.25|-0.37|0.703
72491442|NCT00876187|144510913|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.14|STANDARD_ERROR_OF_MEAN|0.16||0.379|TWO_SIDED|95.0|-0.17|0.45|||ANCOVA|||Change at Week 2: Treatment difference and 95% CI was based on LS mean. ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||0.45|-0.17|0.379
72491443|NCT00876187|144510913|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.49|STANDARD_ERROR_OF_MEAN|0.19||0.012|TWO_SIDED|95.0|-0.87|-0.11|||ANCOVA|||Change at Week 4: Treatment difference and 95% CI was based on LS mean. ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.11|-0.87|0.012
72491444|NCT00876187|144510913|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.03|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|95.0|-1.39|-0.67|||ANCOVA|||Change at Week 4: Treatment difference and 95% CI was based on LS mean. ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.67|-1.39|<0.001
72491445|NCT00876187|144510913|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.94|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|95.0|-1.31|-0.58|||ANCOVA|||Change at Week 4: Treatment difference and 95% CI was based on LS mean. ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.58|-1.31|<0.001
72491446|NCT00876187|144510913|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.03|STANDARD_ERROR_OF_MEAN|0.18||0.862|TWO_SIDED|95.0|-0.33|0.39|||ANCOVA|||Change at Week 4: Treatment difference and 95% CI was based on LS mean. ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||0.39|-0.33|0.862
72491447|NCT00876187|144510913|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.51|STANDARD_ERROR_OF_MEAN|0.17||0.003|TWO_SIDED|95.0|-0.85|-0.17|||ANCOVA|||Change at Week 4: Treatment difference and 95% CI was based on LS mean. ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.17|-0.85|0.003
72491448|NCT00876187|144510913|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.43|STANDARD_ERROR_OF_MEAN|0.17||0.014|TWO_SIDED|95.0|-0.76|-0.09|||ANCOVA|||Change at Week 4: Treatment difference and 95% CI was based on LS mean. ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.09|-0.76|0.014
72491449|NCT00876187|144510913|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.47|STANDARD_ERROR_OF_MEAN|0.2||0.019|TWO_SIDED|95.0|-0.86|-0.08|||ANCOVA|||Change at Week 8: Treatment difference and 95% CI was based on LS mean. ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.08|-0.86|0.019
72517363|NCT04507776|144564454|OTHER||||||<|0.05|||||||t-test, 2 sided|||Year 7 Adherence: Baseline||||<0.05
72517364|NCT04507776|144564454|OTHER|||||||0.43|||||||t-test, 2 sided|||Year 7 Adherence: Year 7||||0.43
72517365|NCT04507776|144564455|OTHER|||||||0.0001|||||||t-test, 2 sided|||Year 1 Adherence: Change at Year 1 (Month 12)||||0.0001
72517366|NCT04507776|144564455|OTHER|||||||0.247|||||||t-test, 2 sided|||Year 7 Adherence: Change at Year 7||||0.247
72517367|NCT04507776|144564456|OTHER|||||||0.21|||||||t-test, 2 sided|||Year 1 Adherence: Baseline||||0.21
72517368|NCT04507776|144564456|OTHER||||||<|0.05|||||||t-test, 2 sided|||Year 1 Adherence: Year 1 (Month 12)||||<0.05
72517369|NCT04507776|144564456|OTHER|||||||0.62|||||||t-test, 2 sided|||Year 7 Adherence: Baseline||||0.62
72517370|NCT04507776|144564456|OTHER|||||||0.18|||||||t-test, 2 sided|||Year 7 Adherence: Year 7||||0.18
72517371|NCT04507776|144564457|OTHER|||||||0.0001|||||||t-test, 2 sided|||Year 1 Adherence: Change at Year 1 (Month 12)||||0.0001
72517372|NCT04507776|144564457|OTHER|||||||0.003|||||||t-test, 2 sided|||Year 7 Adherence: Change at Year 7||||0.003
72517373|NCT00873288|144564484|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|||||||t-test, 2 sided|||||||> 0.05
72405001|NCT00606892|144317319|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|||<|0.05|TWO_SIDED|95.0||||Values of p\<0.05 were considered statistically significant, based on 2-tailed tests. Significant treatment, or treatment-by-time interactions were followed by post hoc comparisons. To account for multiple testing, significance was set at p\<0.016.|Mixed Models Analysis|||A mixed-effect repeated-measures crossover model including fixed main effects for treatment condition (placebo or varenicline), time of measurement and interactions between treatment and time, was utilized. Because multiple measurements were collected before and after each nicotine dose, a change score (maximum post dose score - pre dose baseline) was used in the analysis.||||<0.05
72405002|NCT00606892|144317320|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0||||Post hoc comparisons of effects of varenicline versus placebo for different nicotine doses were performed and significance was adjusted for multiple testing using a p value of P\<0.016|ANOVA|Two-tailed tests were applied for main effects with P\<0.05||A mixed-effect, repeated-measures, crossover model was used with fixed main effects for treatment (placebo or varenicline), and time after treatment. Interactions between main effects were also analyzed.||||<0.05
72405003|NCT04120610|144317351|OTHER||Correlation|0.26|||||TWO_SIDED|95.0|0.1|0.41||||||Descriptive analysis of endpoint with no hypothesis.||0.41|0.10|
72405004|NCT04120610|144317352|OTHER||Correlation|-0.26|||||TWO_SIDED|95.0|-0.46|-0.03||||||Correlation of change in acceleration time and ABI. Descriptive analysis of endpoint with no hypothesis.||-0.03|-0.46|
72405005|NCT04120610|144317352|OTHER||Correlation|-0.33|||||TWO_SIDED|95.0|-0.51|-0.12||||||Correlation of change in acceleration time and ABI. Descriptive analysis of endpoint with no hypothesis.||-0.12|-0.51|
72405006|NCT04120610|144317352|OTHER||Correlation|-0.13|||||TWO_SIDED|95.0|-0.38|0.14||||||Correlation of change in acceleration time and ABI. Descriptive analysis of endpoint with no hypothesis.||0.14|-0.38|
72405007|NCT04120610|144317353|OTHER||Correlation|-0.34|||||TWO_SIDED|95.0|-0.52|-0.12||||||Correlation of change in acceleration time and TBI. Descriptive analysis of endpoint with no hypothesis.||-0.12|-0.52|
72569277|NCT00444457|144669736|NON_INFERIORITY_OR_EQUIVALENCE|The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.|Difference in log-transformed GM|0.14|||||TWO_SIDED|95.0|0.02|0.25|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Additional serotypes - serotype 6A||0.25|0.02|
72405008|NCT04120610|144317353|OTHER||Correlation|-0.35|||||TWO_SIDED|95.0|-0.52|-0.15||||||Correlation of change in acceleration time and TBI. Descriptive analysis of endpoint with no hypothesis.||-0.15|-0.52|
72405009|NCT04120610|144317353|OTHER||Correlation|-0.24|||||TWO_SIDED|95.0|-0.47|0.02||||||Correlation of change in acceleration time and TBI. Descriptive analysis of endpoint with no hypothesis.||0.02|-0.47|
72405010|NCT04120610|144317354|OTHER||Correlation|0.15|||||TWO_SIDED|95.0|-0.08|0.36||||||Correlation of change in acceleration time and Rutherford Classification. Descriptive analysis of endpoint with no hypothesis.||0.36|-0.08|
72405011|NCT04120610|144317354|OTHER||Correlation|0.19|||||TWO_SIDED|95.0|-0.02|0.39||||||Correlation of change in acceleration time and Rutherford Classification. Descriptive analysis of endpoint with no hypothesis.||0.39|-0.02|
72405012|NCT04120610|144317354|OTHER||Correlation|0.24|||||TWO_SIDED|95.0|-0.02|0.47||||||Correlation of change in acceleration time and Rutherford Classification. Descriptive analysis of endpoint with no hypothesis.||0.47|-0.02|
72405013|NCT01874262|144317376|SUPERIORITY_OR_OTHER|||||||0.025|||||||Wilcoxon (Mann-Whitney)|||||||0.025
72405014|NCT00544076|144317382|EQUIVALENCE|The equivalence margin that would be possible to detect (had the protocol reached intended accrual) was 20%,|||||>|0.1||||||no adjustments were made.|Fisher Exact|||||||>0.1
72405015|NCT00544076|144317383|OTHER||||||>|0.1||||||no adjustments done|Chi-squared|no adjustments||compare percentage of patients potent at 6 and 18 months across pairs of treatment arms (arm I vs arm II, arm I vs arm III, arm II vs arm III)||||>0.1
72405016|NCT00544076|144317384|OTHER||||||>|0.2||||||no adjustments done.|ANOVA|||||||>0.2
72405017|NCT00544076|144317385|OTHER||Mean Difference (Final Values)|0.08||||0.08|TWO_SIDED|||||no adjustments|ANOVA|no adjustments for df||"ANOVA test to compare difference of penile length (from baseline to month 18) across arms.~calculations are underpowered, as study did not accrue or retain patients as intended, and many patients declined to have measurements taken."||||0.08
72405018|NCT01495585|144317455|SUPERIORITY_OR_OTHER|||||||0.03|||||||t-test, 2 sided|||Student t-test was used on the change in serum log HDV RNA after 28 days of therapy with lonafarnib.||||0.03
72405019|NCT01495585|144317455|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||Student t-test was used on the change in serum log HDV RNA after 28 days of therapy with lonafarnib.||||<0.0001
72405020|NCT01495585|144317456|SUPERIORITY_OR_OTHER|||||||0.96|||||||Wilcoxon (Mann-Whitney)|||||||0.96
72405021|NCT01495585|144317456|SUPERIORITY_OR_OTHER|||||||0.6|||||||Wilcoxon (Mann-Whitney)|||||||0.6
72405022|NCT01399593|144317470|SUPERIORITY||Proportion difference|-3.9||||0.76|TWO_SIDED|95.0|-23.9|16.3|||Fisher Exact|||||16.3|-23.9|0.76
72405023|NCT00403273|144317486|SUPERIORITY|||||||0.01||||||p-value not adjusted for multiple comparisons; the a priori threshold for statistical significance was \<0.05|t-test, 2 sided|||||||0.01
72405024|NCT00403273|144317487|SUPERIORITY_OR_OTHER||comparison of proportions|0.65|||<|0.05|TWO_SIDED|95.0||||No adjustment for multiple comparisons was made, since we analyzed only one primary outcome. 19 patients per group were needed for 80% power and 24 patients per group for 90% power to detect a difference of 43% in proportion with primary outcome|comparison of proportions|compare proportion of patients with clinically meaningful change in 0-10 VAS pain (at least 2-point reduction on VAS pain) at 2-mths \& all timepoints|we hypothesized a greater proportion with meaningful reduction in pain on 0-10 scale in intervention versus placebo group.|For primary outcome analysis, we compared the proportion of responders with clinically meaningful change \[improvement\] in 0-10 VAS Pain, i.e. those with 2-point reduction in 0-10 VAS pain score at 2-mths, in the 2 groups using comparison of proportions. Proportion of responders were also analyzed at all efficacy timepoints using generalized estimating equation (GEE) modeling. We used GEE for between-group comparisons in secondary outcomes at all efficacy endpoints, adjusted for baseline scores.||||<0.05
72405025|NCT00403273|144317488|SUPERIORITY|||||||0.01|||||||t-test, 2 sided|||||||0.01
72405026|NCT00403273|144317489|SUPERIORITY|||||||0.004|||||||t-test, 2 sided|||||||0.004
72405027|NCT00403273|144317490|SUPERIORITY|||||||0.046|||||||t-test, 2 sided|||||||0.046
72491450|NCT00876187|144510913|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.88|STANDARD_ERROR_OF_MEAN|0.19|<|0.001|TWO_SIDED|95.0|-1.25|-0.51|||ANCOVA|||Change at Week 8: Treatment difference and 95% CI was based on LS mean. ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.51|-1.25|<0.001
72491451|NCT00876187|144510913|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.93|STANDARD_ERROR_OF_MEAN|0.19|<|0.001|TWO_SIDED|95.0|-1.29|-0.56|||ANCOVA|||Change at Week 8: Treatment difference and 95% CI was based on LS mean. ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.56|-1.29|<0.001
72491452|NCT00876187|144510913|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.19||0.668|TWO_SIDED|95.0|-0.45|0.29|||ANCOVA|||Change at Week 8: Treatment difference and 95% CI was based on LS mean. ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||0.29|-0.45|0.668
72491453|NCT00876187|144510913|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.49|STANDARD_ERROR_OF_MEAN|0.18||0.005|TWO_SIDED|95.0|-0.84|-0.15|||ANCOVA|||Change at Week 8: Treatment difference and 95% CI was based on LS mean. ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.15|-0.84|0.005
72491454|NCT00876187|144510913|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.54|STANDARD_ERROR_OF_MEAN|0.18||0.002|TWO_SIDED|95.0|-0.88|-0.19|||ANCOVA|||Change at Week 8: Treatment difference and 95% CI was based on LS mean. ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.19|-0.88|0.002
72491455|NCT00876187|144510913|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.46|STANDARD_ERROR_OF_MEAN|0.22||0.032|TWO_SIDED|95.0|-0.89|-0.04|||ANCOVA|||Change at Week 12: Treatment difference and 95% CI was based on LS mean. ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.04|-0.89|0.032
72491456|NCT00876187|144510913|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.81|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|-1.21|-0.41|||ANCOVA|||Change at Week 12: Treatment difference and 95% CI was based on LS mean. ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.41|-1.21|<0.001
72491457|NCT00876187|144510913|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.88|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|-1.28|-0.48|||ANCOVA|||Change at Week 12: Treatment difference and 95% CI was based on LS mean. ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.48|-1.28|<0.001
72491458|NCT00876187|144510913|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.2||0.773|TWO_SIDED|95.0|-0.46|0.34|||ANCOVA|||Change at Week 12: Treatment difference and 95% CI was based on LS mean. ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||0.34|-0.46|0.773
72491459|NCT00876187|144510913|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.19||0.035|TWO_SIDED|95.0|-0.78|-0.03|||ANCOVA|||Change at Week 12: Treatment difference and 95% CI was based on LS mean. ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.03|-0.78|0.035
72491460|NCT00876187|144510913|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.47|STANDARD_ERROR_OF_MEAN|0.19||0.014|TWO_SIDED|95.0|-0.85|-0.1|||ANCOVA|||Change at Week 12: Treatment difference and 95% CI was based on LS mean. ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.10|-0.85|0.014
72491461|NCT01560780|144510939|SUPERIORITY|||||||0.78|||||||Fisher Exact|||||||0.78
72491462|NCT01560780|144510940|EQUIVALENCE|safety end-point with p-value of \<0.05|||||>|0.99|||||||Log Rank|||||||>0.99
72491463|NCT01560780|144510941|SUPERIORITY|||||||0.19|||||||Fisher Exact|||||||0.19
72491464|NCT01560780|144510942|SUPERIORITY|||||||0.85|||||||t-test, 2 sided|||||||0.85
72491465|NCT01560780|144510943|SUPERIORITY|||||||0.97|||||||t-test, 2 sided|||||||0.97
72491466|NCT01560780|144510945|SUPERIORITY|||||||0.97|||||||t-test, 2 sided|||||||0.97
72624767|NCT01346592|144778965|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (H3N2 strain)|-9.0|||||TWO_SIDED|95.0|-38.4|14.3||||||At risk subjects.||14.3|-38.4|
72491467|NCT04442230|144511034|SUPERIORITY|||||||0.6602|||||||Fisher Exact|||The p-values from significance tests were obtained at a one-sided significance level of 0.025.||||0.6602
72491468|NCT01604265|144511037|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-1.25||||0.005|TWO_SIDED|95.0|-2.11|-0.39|||ANCOVA|||The change was compared between treatment groups using a one way analysis of covariance (ANCOVA). The significance of the treatment effect, after adjusting for baseline pain score, was assessed using the F-test from the ANCOVA. The model was as follows: Change in 0-10 Numerical Rating Scale Pain Score = Baseline Pain Score + Treatment||-0.39|-2.11|0.005
72491469|NCT01604265|144511038|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-1.39||||0.003|TWO_SIDED|95.0|-2.27|-0.5|||ANCOVA|||"The change was compared between treatment groups using a one way ANCOVA. The significance of the treatment effect, after adjusting for baseline sleep score, was assessed using the F-test from the ANCOVA. The model was as follows:~Change in 0-10 Numerical Rating Scale sleep Score = Baseline Sleep Score + Treatment"||-0.50|-2.27|0.003
72517374|NCT00873288|144564486|SUPERIORITY|||||||0.207|||||||Chi-squared|The Pearson Chi-squared value = 1.590||||||0.207
72517375|NCT00873288|144564487|SUPERIORITY_OR_OTHER_LEGACY|||||||0.66|||||||t-test, 2 sided|||||||0.66
72517376|NCT04131933|144564524|SUPERIORITY|It was hypothesized that there would be a 50% reduction in Oncotype DX assay requests following the intervention.||||||0.37|||||||Fisher Exact|Fisher's exact test to compare number of patients with Oncotype DX ordered at 0-6 months (pre-intervention) vs 7-12 months (post-intervention)||Pre-Intervention (Period 1 and Period 2) vs Post-Intervention (Period 3 and Period 4)||||0.37
72405028|NCT00403273|144317491|SUPERIORITY|||||||0.03|||||||t-test, 2 sided|||||||0.03
72405029|NCT00403273|144317492|SUPERIORITY|||||||0.03|||||||t-test, 2 sided|||||||0.03
72405030|NCT04041869|144317493|SUPERIORITY||Mean Difference (Final Values)|0.01|||<|0.01|TWO_SIDED||||||Mixed Models Analysis|||In order to test the effect of the intervention on physical activity, linear mixed models examined changes in steps per day from study baseline (week 0) to the end of the active intervention (week 8).||||<0.01
72405031|NCT01336738|144317498|SUPERIORITY_OR_OTHER||Least Squares (LS) Mean Difference|0.08|STANDARD_ERROR_OF_MEAN|0.164||0.6803|TWO_SIDED|80.0|-0.13|0.29||One-sided p-value was calculated.|Mixed Models Analysis|||Treatment difference and 80% confidence interval (CI) were based on LS mean. A mixed model repeated measure (MMRM) analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction as the covariates, time was repeated for participant.||0.29|-0.13|0.6803
72491470|NCT01604265|144511039|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|3.896||||0.005|TWO_SIDED|95.0|1.51|10.055|||Regression, Logistic|||"The proportion of patients who considered their condition Very Much Improved or Much Improved was compared between treatment groups using a Fisher's Exact Test. Results were presented in terms of difference in percentages, and 95% CI based on the normal approximation to the binomial, and p-value."||10.055|1.510|0.005
72491471|NCT01604265|144511040|SUPERIORITY_OR_OTHER_LEGACY||estimated mean treatment difference|-6.82||||0.039|TWO_SIDED|95.0|-13.28|-0.37|||ANCOVA|||The change was compared between treatment groups using a one way ANCOVA. The significance of the treatment effect, after adjusting for baseline score, was assessed using the F-test from the ANCOVA.||-0.37|-13.28|0.039
72491472|NCT01604265|144511041|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-6.95||||0.009|TWO_SIDED|95.0|-12.12|-1.77|||ANCOVA|||The change was compared between treatment groups using a one way ANCOVA. The significance of the treatment effect, after adjusting for baseline score, was assessed using the F-test from the ANCOVA.||-1.77|-12.12|0.009
72491473|NCT01604265|144511042|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|2.54||||0.23|TWO_SIDED|95.0|-1.64|6.71|||ANCOVA|||The change was compared between treatment groups using a one way ANCOVA. The significance of the treatment effect, after adjusting for baseline score, was assessed using the F-test from the ANCOVA.||6.71|-1.64|0.230
72491474|NCT01604265|144511043|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-2.53||||0.064|TWO_SIDED|95.0|-5.22|0.15|||ANCOVA|||The change was compared between treatment groups using a one way ANCOVA. The significance of the treatment effect, after adjusting for baseline score, was assessed using the F-test from the ANCOVA.||0.15|-5.22|0.064
72517377|NCT04295356|144564545|EQUIVALENCE|The 90% confidence interval of the ratio of geometric least squares means of Cmax was estimated to assess the PK similarity between CT-P17 AI and CT-P17 PFS (bioequivalence margin of 80% to 125%).|Ratio of geometric least squares means|102.6|||||TWO_SIDED|90.0|94.08|111.9|||ANCOVA|The stratification factors (gender \[male or female\], study center, and body weight as measured on Day -1) were included in ANCOVA model as covariates.||Equivalence test in Cmax between CT-P17 AI and CT-P17 PFS||111.90|94.08|
72517378|NCT04295356|144564546|EQUIVALENCE|The 90% confidence interval of the ratio of geometric least squares means of AUC0-inf was estimated to assess the PK similarity between CT-P17 AI and CT-P17 PFS (bioequivalence margin of 80% to 125%).|Ratio of geometric least squares means|103.64|||||TWO_SIDED|90.0|93.98|114.29|||ANCOVA|The stratification factors (gender \[male or female\], study center, and body weight as measured on Day -1) were included in ANCOVA model as covariates.||Equivalence test in AUC0-inf between CT-P17 AI and CT-P17 PFS||114.29|93.98|
72517379|NCT04295356|144564547|EQUIVALENCE|The 90% confidence interval of the ratio of geometric least squares means of AUC0-last was estimated to assess the PK similarity between CT-P17 AI and CT-P17 PFS (bioequivalence margin of 80% to 125%).|Ratio of geometric least squares means|105.36|||||TWO_SIDED|90.0|91.09|121.86|||ANCOVA|The stratification factors (gender \[male or female\], study center, and body weight as measured on Day -1) were included in ANCOVA model as covariates.||Equivalence test in AUC0-last between CT-P17 AI and CT-P17 PFS||121.86|91.09|
72517380|NCT01106391|144564555|SUPERIORITY_OR_OTHER_LEGACY||Rate of technical success (%)|90.0|||||TWO_SIDED|95.0|79.5|96.2|||||The 95% confidence interval was based on the exact confidence interval (Collett, 1991)|Since this was a feasibility study without comparisons, sample size was not determined based on statistical consideration. No formal hypothesis testing was performed either.||96.2|79.5|
72517381|NCT01106391|144564556|SUPERIORITY_OR_OTHER_LEGACY||Rate of achieved primary safety(%)|97.0|||||TWO_SIDED|95.0|88.1|99.6|||||The 95% confidence interval was based on the exact confidence interval (Collett, 1991)|Since this was a feasibility study without comparisons, sample size was not determined based on statistical consideration. No formal hypothesis testing was performed either.||99.6|88.1|
72569278|NCT00444457|144669736|NON_INFERIORITY_OR_EQUIVALENCE|The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.|Difference in log-transformed GM|0.12|||||TWO_SIDED|95.0|0.01|0.24|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Additional serotypes - serotype 6A||0.24|0.01|
72491475|NCT01604265|144511044|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|0.29|STANDARD_ERROR_OF_MEAN|2.44||0.905|TWO_SIDED|95.0|-4.6|5.18|||ANCOVA|||The change was compared between treatment groups using a one way ANCOVA. The significance of the treatment effect, after adjusting for baseline score, was assessed using the F-test from the ANCOVA.||5.18|-4.60|0.905
72517382|NCT04426890|144564565|EQUIVALENCE|Therapeutic equivalence was declared if the two-sided 90% confidence interval (CI) for the treatment difference was entirely within an equivalence margin of \[-2.5, 2.0\].|Mean Difference (Net)|0.7|||||TWO_SIDED|90.0|-0.22|1.63||||||The statistical analysis of mean change from baseline in ISS7 at Week 12 between CT-P39 300 mg treatment arm (Arm 1) and Xolair 300 mg treatment arm (Arm 2), using ANCOVA with multiple imputation based on the MAR assumption was performed for the mITT Set.||1.63|-0.22|
72405032|NCT01336738|144317498|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.49|STANDARD_ERROR_OF_MEAN|0.166||0.0017|TWO_SIDED|80.0|-0.71|-0.28||One-sided p-value was calculated.|Mixed Models Analysis|||Treatment difference and 80% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction as the covariates, time was repeated for participant.||-0.28|-0.71|0.0017
72517383|NCT04268004|144564621|OTHER|Chi-squared test was used to determine if study arm is associated with FP uptake.|||||=|0.64|||||||Chi-squared|df=(1, 19)||Chi-square test was used to determine if study arm is associated with FP uptake.||||=.64
72405033|NCT01336738|144317498|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.58|STANDARD_ERROR_OF_MEAN|0.168||0.0003|TWO_SIDED|80.0|-0.8|-0.36||One-sided p-value was calculated.|Mixed Models Analysis|||Treatment difference and 80% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction as the covariates, time was repeated for participant.||-0.36|-0.80|0.0003
72491476|NCT01604265|144511045|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|2.68||||0.257|TWO_SIDED|95.0|-2.01|7.37|||ANCOVA|||The change was compared between treatment groups using a one way ANCOVA. The significance of the treatment effect, after adjusting for baseline score, was assessed using the F-test from the ANCOVA.||7.37|-2.01|0.257
72491477|NCT01604265|144511046|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-1.5||||0.164|TWO_SIDED|95.0|-3.64|0.63|||ANCOVA|||The change was compared between treatment groups using a one way ANCOVA. The significance of the treatment effect, after adjusting for baseline score, was assessed using the F-test from the ANCOVA.||0.63|-3.64|0.164
72491478|NCT01604265|144511048|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|0.09||||0.88|TWO_SIDED|95.0|-1.06|1.23|||ANCOVA|||The change was compared between treatment groups using a one way ANCOVA. The significance of the treatment effect, after adjusting for baseline score, was assessed using the F-test from the ANCOVA.||1.23|-1.06|0.880
72491479|NCT01604265|144511049|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-0.64||||0.249|TWO_SIDED|95.0|-1.75|0.46|||ANCOVA|||The change was compared between treatment groups using a one way ANCOVA. The significance of the treatment effect, after adjusting for baseline score, was assessed using the F-test from the ANCOVA.||0.46|-1.75|0.249
72491480|NCT01604265|144511050|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|0.06||||0.535|TWO_SIDED|95.0|-0.13|0.24|||ANCOVA|||The change was compared between treatment groups using a one way ANCOVA. The significance of the treatment effect, after adjusting for baseline score, was assessed using the F-test from the ANCOVA.||0.24|-0.13|0.535
72491481|NCT02706873|144511052|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two upadacitinib doses (15 mg and 30 mg) was controlled using a graphical multiple testing procedure defined separately for US/FDA, European Union/European Medicines Agency and Japan/Pharmaceuticals and Medical Devices Agency regulatory purposes.|Response Rate Difference|23.7|||<|0.001|TWO_SIDED|95.0|16.3|31.1||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusting for geographic region (North America, South/central America, Western Europe, Eastern Europe, Asia/other).|Response Rate Difference = Upadacitinib - Methotrexate|For the global analysis, comparisons of the primary and key secondary efficacy endpoints were made between the upadacitinib 15 mg and 30 mg groups versus the methotrexate group.||31.1|16.3|<0.001
72491482|NCT02706873|144511052|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two upadacitinib doses (15 mg and 30 mg) was controlled using a graphical multiple testing procedure defined separately for US/FDA, European Union/European Medicines Agency and Japan/Pharmaceuticals and Medical Devices Agency regulatory purposes.|Response Rate Difference|28.0|||<|0.001|TWO_SIDED|95.0|20.6|35.4||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusting for geographic region (North America, South/central America, Western Europe, Eastern Europe, Asia/other).|Response Rate Difference = Upadacitinib - Methotrexate|For the global analysis, comparisons of the primary and key secondary efficacy endpoints were made between the upadacitinib 15 mg and 30 mg groups versus the methotrexate group.||35.4|20.6|<0.001
72491483|NCT02706873|144511053|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two upadacitinib doses (15 mg and 30 mg) was controlled using a graphical multiple testing procedure defined separately for US/FDA, European Union/European Medicines Agency and Japan/Pharmaceuticals and Medical Devices Agency regulatory purposes.|Response Rate Difference|29.8|||<|0.001|TWO_SIDED|95.0|22.8|36.8||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusting for geographic region (North America, South/central America, Western Europe, Eastern Europe, Asia/other).|Response Rate Difference = Upadacitinib - Methotrexate|For the global analysis, comparisons of the primary and key secondary efficacy endpoints were made between the upadacitinib 15 mg and 30 mg groups versus the methotrexate group.||36.8|22.8|<0.001
72491484|NCT02706873|144511053|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two upadacitinib doses (15 mg and 30 mg) was controlled using a graphical multiple testing procedure defined separately for US/FDA, European Union/European Medicines Agency and Japan/Pharmaceuticals and Medical Devices Agency regulatory purposes.|Response Rate Difference|31.5|||<|0.001|TWO_SIDED|95.0|24.5|38.5|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusting for geographic region (North America, South/central America, Western Europe, Eastern Europe, Asia/other).|Response Rate Difference = Upadacitinib - Methotrexate|For the global analysis, comparisons of the primary and key secondary efficacy endpoints were made between the upadacitinib 15 mg and 30 mg groups versus the methotrexate group.||38.5|24.5|<0.001
72517384|NCT03783442|144564626|SUPERIORITY||Stratified Hazard Ratio|0.66|||<|0.0001|TWO_SIDED|95.0|0.54|0.8|||Stratified Log-rank Test|One-sided p-value estimated from log rank test stratified by pooled geographic region, prior definitive therapy and Investigator chemotherapy choice|Stratified Hazard ratio was based on Cox regression model including treatment arm as a covariate and stratified by pooled geographic region (Asia vs. Rest of World), prior definitive therapy and Investigator choice of chemotherapy as strata.|||0.80|0.54|<0.0001
72517385|NCT03783442|144564627|SUPERIORITY||Stratified Hazard Ratio|0.62|||<|0.0001|TWO_SIDED|95.0|0.52|0.75|||Stratified Log-rank test|One-sided p-value estimated from log rank test stratified by pooled geographic region, prior definitive therapy and Investigator chemotherapy choice.|Stratified Hazard ratio was based on Cox regression model including treatment arm as a covariate and stratified by pooled geographic region (Asia vs. Rest of World), prior definitive therapy and Investigator choice of chemotherapy as strata.|||0.75|0.52|<0.0001
72624768|NCT01346592|144778965|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (B strain)|21.0|||||TWO_SIDED|95.0|-7.9|48.1||||||At risk subjects.||48.1|-7.9|
72405034|NCT01336738|144317498|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.71|STANDARD_ERROR_OF_MEAN|0.162|<|0.0001|TWO_SIDED|80.0|-0.91|-0.5||One-sided p-value was calculated.|Mixed Models Analysis|||Treatment difference and 80% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction as the covariates, time was repeated for participant.||-0.50|-0.91|<0.0001
72405035|NCT01336738|144317499|SUPERIORITY_OR_OTHER||LS Mean Difference|3.78|STANDARD_ERROR_OF_MEAN|5.292||0.4757|TWO_SIDED|95.0|-6.64|14.2||Two-sided p-value was calculated.|Mixed Models Analysis|||Week 1: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||14.20|-6.64|0.4757
72491485|NCT02706873|144511054|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two upadacitinib doses (15 mg and 30 mg) was controlled using a graphical multiple testing procedure defined separately for US/FDA, European Union/European Medicines Agency and Japan/Pharmaceuticals and Medical Devices Agency regulatory purposes.|Response Rate Difference|21.6|||<|0.001|TWO_SIDED|95.0|14.3|28.8||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusting for geographic region (North America, South/central America, Western Europe, Eastern Europe, Asia/other).|Response Rate Difference = Upadacitinib - Methotrexate|For the global analysis, comparisons of the primary and key secondary efficacy endpoints were made between the upadacitinib 15 mg and 30 mg groups versus the methotrexate group.||28.8|14.3|<0.001
72491486|NCT02706873|144511054|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two upadacitinib doses (15 mg and 30 mg) was controlled using a graphical multiple testing procedure defined separately for US/FDA, European Union/European Medicines Agency and Japan/Pharmaceuticals and Medical Devices Agency regulatory purposes.|Response Rate Difference|22.9|||<|0.001|TWO_SIDED|95.0|15.7|30.1||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusting for geographic region (North America, South/central America, Western Europe, Eastern Europe, Asia/other).|Response Rate Difference = Upadacitinib - Methotrexate|For the global analysis, comparisons of the primary and key secondary efficacy endpoints were made between the upadacitinib 15 mg and 30 mg groups versus the methotrexate group.||30.1|15.7|<0.001
72491487|NCT02706873|144511055|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two upadacitinib doses (15 mg and 30 mg) was controlled using a graphical multiple testing procedure defined separately for US/FDA, European Union/European Medicines Agency and Japan/Pharmaceuticals and Medical Devices Agency regulatory purposes.|Least Squares (LS) Mean Difference|-0.53||||0.001|TWO_SIDED|95.0|-0.85|-0.2||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|ANCOVA|Analysis of covariance (ANCOVA) model with treatment, geographic region as fixed factors and baseline value as the covariate.|Difference = Upadacitinib - Methotrexate|For the global analysis, comparisons of the primary and key secondary efficacy endpoints were made between the upadacitinib 15 mg and 30 mg groups versus the methotrexate group.||-0.20|-0.85|0.001
72491488|NCT02706873|144511055|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two upadacitinib doses (15 mg and 30 mg) was controlled using a graphical multiple testing procedure defined separately for US/FDA, European Union/European Medicines Agency and Japan/Pharmaceuticals and Medical Devices Agency regulatory purposes.|LS Mean Difference|-0.59|||<|0.001|TWO_SIDED|95.0|-0.91|-0.27||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|ANCOVA|ANCOVA model with treatment and geographic region as fixed factors and Baseline value as the covariate.|Difference = Upadacitinib - Methotrexate|For the global analysis, comparisons of the primary and key secondary efficacy endpoints were made between the upadacitinib 15 mg and 30 mg groups versus the methotrexate group.||-0.27|-0.91|<0.001
72491489|NCT02706873|144511056|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure. This endpoint was a ranked key secondary endpoint for US/FDA and Japan/PMDA regulatory purposes.|LS Mean Difference|-0.88|||<|0.001|TWO_SIDED|95.0|-1.09|-0.67||The nominal p-value is reported|ANCOVA|ANCOVA model with treatment and geographic region as fixed factors and Baseline value as the covariate.||||-0.67|-1.09|<0.001
72491490|NCT02706873|144511056|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure. This endpoint was a ranked key secondary endpoint for US/FDA and Japan/PMDA regulatory purposes.|LS Mean Difference|-1.01|||<|0.001|TWO_SIDED|95.0|-1.21|-0.8||The nominal p-value is reported|ANCOVA|ANCOVA model with treatment and geographic region as fixed factors and Baseline value as the covariate.|Difference = Upadacitinib - Methotrexate|||-0.80|-1.21|<0.001
72491491|NCT02706873|144511057|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure. This endpoint was a ranked key secondary endpoint for US/FDA and Japan/PMDA regulatory purposes.|LS Mean Difference|-0.34|||<|0.001|TWO_SIDED|95.0|-0.44|-0.25||The nominal p-value is reported|ANCOVA|ANCOVA model with treatment and geographic region as fixed factors and Baseline value as the covariate.|Difference = Upadacitinib - Methotrexate|||-0.25|-0.44|<0.001
72517386|NCT03783442|144564628|SUPERIORITY||Odds Ratio (OR)|2.38|||<|0.0001|TWO_SIDED|95.0|1.73|3.27|||Cochran-Mantel-Haenszel|Two-sided Cochran-Mantel-Haenszel test was stratified by pooled geographic region, prior definitive therapy, and Investigator choice of chemotherapy.|Odds ratio was calculated using the Cochran-Mantel-Haenszel method, stratified by pooled geographic region, prior definitive therapy, and Investigator choice of chemotherapy.|||3.27|1.73|<0.0001
72405036|NCT01336738|144317499|SUPERIORITY_OR_OTHER||LS Mean Difference|1.32|STANDARD_ERROR_OF_MEAN|5.296||0.8031|TWO_SIDED|95.0|-9.11|11.75||Two-sided p-value was calculated.|Mixed Models Analysis|||Week 1: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||11.75|-9.11|0.8031
72491492|NCT02706873|144511057|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure. This endpoint was a ranked key secondary endpoint for US/FDA and Japan/PMDA regulatory purposes.|LS Mean Difference|-0.37|||<|0.001|TWO_SIDED|95.0|-0.47|-0.28||The nominal p-value is reported|ANCOVA|ANCOVA model with treatment and geographic region as fixed factors and Baseline value as the covariate.|Difference = Upadacitinib - Methotrexate|||-0.28|-0.47|<0.001
72491493|NCT02706873|144511058|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure. This endpoint was a ranked key secondary endpoint for US/FDA and Japan/PMDA regulatory purposes.|Response Rate Difference|25.0|||<|0.001|TWO_SIDED|95.0|17.6|32.4||The nominal p-value is reported|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusting for geographic region (North America, South/central America, Western Europe, Eastern Europe, Asia/other).|Response Rate Difference = Upadacitinib - Methotrexate|||32.4|17.6|<0.001
72491494|NCT02706873|144511058|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure. This endpoint was a ranked key secondary endpoint for US/FDA and Japan/PMDA regulatory purposes.|Response Rate Difference|26.4|||<|0.001|TWO_SIDED|95.0|19.0|33.9||The nominal p-value is reported|Chi-squared, Corrected|Cochran-Mantel-Haenszel test adjusting for geographic region (North America, South/central America, Western Europe, Eastern Europe, Asia/other).|||Response Rate Difference = Upadacitinib - Methotrexate|33.9|19.0|<0.001
72491495|NCT02706873|144511059|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure. This endpoint was a ranked key secondary endpoint for US/FDA and Japan/PMDA regulatory purposes.|LS Mean Difference|4.25|||<|0.001|TWO_SIDED|95.0|3.0|5.5||The nominal p-value is reported|ANCOVA|ANCOVA model with treatment and geographic region as fixed factors and Baseline value as the covariate.|Difference = Upadacitinib - Methotrexate|||5.50|3.00|<0.001
72491496|NCT02706873|144511059|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure. This endpoint was a ranked key secondary endpoint for US/FDA and Japan/PMDA regulatory purposes.|LS Mean Difference|4.34|||<|0.001|TWO_SIDED|95.0|3.09|5.59||The nominal p-value is reported|ANCOVA|ANCOVA model with treatment and geographic region as fixed factors and Baseline value as the covariate.|Difference = Upadacitinib - Methotrexate|||5.59|3.09|<0.001
72491497|NCT02706873|144511060|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure. This endpoint was a ranked key secondary endpoint for EU/EMA regulatory purposes.|LS Mean Difference|-0.92|||<|0.001|TWO_SIDED|95.0|-1.12|-0.71||The nominal p-value is reported|ANCOVA|ANCOVA model with treatment and geographic region as fixed factors and Baseline value as the covariate.|Difference = Upadacitinib - Methotrexate|||-0.71|-1.12|<0.001
72491498|NCT02706873|144511060|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure. This endpoint was a ranked key secondary endpoint for EU/EMA regulatory purposes.|LS Mean Difference|-1.19|||<|0.001|TWO_SIDED|95.0|-1.4|-0.99||The nominal p-value is reported|ANCOVA|ANCOVA model with treatment and geographic region as fixed factors and Baseline value as the covariate.|Difference = Upadacitinib - Methotrexate|||-0.99|-1.40|<0.001
72491499|NCT02706873|144511061|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure. This endpoint was a ranked key secondary endpoint for EU/EMA regulatory purposes.|LS Mean Difference|-0.27|||<|0.001|TWO_SIDED|95.0|-0.37|-0.17||The nominal p-value is reported|ANCOVA|ANCOVA model with treatment and geographic region as fixed factors and Baseline value as the covariate.|Difference = Upadacitinib - Methotrexate|||-0.17|-0.37|<0.001
72491500|NCT02706873|144511061|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure. This endpoint was a ranked key secondary endpoint for EU/EMA regulatory purposes.|LS Mean Difference|-0.31|||<|0.001|TWO_SIDED|95.0|-0.41|-0.21||The nominal p-value is reported|ANCOVA|ANCOVA model with treatment and geographic region as fixed factors and Baseline value as the covariate.|Difference = Upadacitinib - Methotrexate|||-0.21|-0.41|<0.001
72491501|NCT02706873|144511062|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure. This endpoint was a ranked key secondary endpoint for EU/EMA regulatory purposes.|Response Rate Difference|26.8|||<|0.001|TWO_SIDED|95.0|19.3|34.3||The nominal p-value is reported|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusting for geographic region (North America, South/central America, Western Europe, Eastern Europe, Asia/other).|Response Rate Difference = Upadacitinib - Methotrexate|||34.3|19.3|<0.001
72517387|NCT03783442|144564629|SUPERIORITY||Stratified Hazard Ratio|0.62||||0.0029|TWO_SIDED|95.0|0.44|0.87|||Stratified Log-rank test|One-sided p-value estimated from log rank test stratified by pooled geographic region, prior definitive therapy and Investigator chemotherapy choice.|Stratified Hazard ratio was based on Cox regression model including treatment arm as a covariate and stratified by pooled geographic region (Asia vs. Rest of World), prior definitive therapy and Investigator choice of chemotherapy as strata.|||0.87|0.44|0.0029
72517388|NCT03783442|144564631|SUPERIORITY||Least Squares (LS) Mean Difference|4.4||||0.1372|TWO_SIDED|95.0|-1.4|10.3|||Mixed Models Analysis|Two-sided p-value estimated from a mixed effect model|Based on a mixed effect model analysis with QLQ-OES18 scores until cycle 18 as the response variable, and treatment by study visit interaction, Baseline mean score, and randomization stratification factors as covariates.|Analysis of Change from Baseline in EORTC QLQ-OES18 Dysphagia Score at Cycle 6||10.3|-1.4|0.1372
72491502|NCT02706873|144511062|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure. This endpoint was a ranked key secondary endpoint for EU/EMA regulatory purposes.|Response Rate Difference|32.2|||<|0.001|TWO_SIDED|95.0|24.8|39.6||The nominal p-value is reported|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusting for geographic region (North America, South/central America, Western Europe, Eastern Europe, Asia/other).|Response Rate Difference = Upadacitinib - Methotrexate|||39.6|24.8|<0.001
72624769|NCT01346592|144778965|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (H1N1 strain)|10.0|||||TWO_SIDED|95.0|3.0|18.5||||||No risk subjects.||18.5|3|
72491503|NCT02706873|144511063|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure. This endpoint was a ranked key secondary endpoint for EU/EMA regulatory purposes.|Response Rate Difference|27.8|||<|0.001|TWO_SIDED|95.0|20.3|35.2||The nominal p-value is reported|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusting for geographic region (North America, South/central America, Western Europe, Eastern Europe, Asia/other).|Response Rate Difference = Upadacitinib - Methotrexate|||35.2|20.3|<0.001
72491504|NCT02706873|144511063|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure. This endpoint was a ranked key secondary endpoint for EU/EMA regulatory purposes.|Response Rate Difference|32.8|||<|0.001|TWO_SIDED|95.0|25.4|40.2||The nominal p-value is reported|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusting for geographic region (North America, South/central America, Western Europe, Eastern Europe, Asia/other).|Response Rate Difference = Upadacitinib - Methotrexate|||40.2|25.4|<0.001
72517389|NCT03783442|144564631|SUPERIORITY||LS Mean Difference|0.6||||0.713|TWO_SIDED|95.0|-2.5|3.7|||Mixed Models Analysis|Two-sided p-value estimated from a mixed effect model|Based on a mixed effect model analysis with QLQ-OES18 scores until cycle 18 as the response variable, and treatment by study visit interaction, Baseline mean score, and randomization stratification factors as covariates.|Analysis of Change from Baseline in EORTC QLQ-OES18 Eating Score at Cycle 6||3.7|-2.5|0.7130
72491505|NCT02706873|144511064|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure. This endpoint was a ranked key secondary endpoint for EU/EMA regulatory purposes.|LS Mean Difference|3.72|||<|0.001|TWO_SIDED|95.0|2.42|5.03||The nominal p-value is reported|ANCOVA|ANCOVA model with treatment and geographic region as fixed factors and Baseline value as the covariate.|Difference = Upadacitinib - Methotrexate|||5.03|2.42|<0.001
72491506|NCT02706873|144511064|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure. This endpoint was a ranked key secondary endpoint for EU/EMA regulatory purposes.|LS Mean Difference|4.42|||<|0.001|TWO_SIDED|95.0|3.12|5.72||The nominal p-value is reported|ANCOVA|ANCOVA model with treatment and geographic region as fixed factors and Baseline value as the covariate.|Difference = Upadacitinib - Methotrexate|||5.72|3.12|<0.001
72491507|NCT02706873|144511065|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure. This endpoint was a ranked key secondary endpoint for EU/EMA regulatory purposes.|Response Rate Difference|9.8||||0.002|TWO_SIDED|95.0|3.5|16.2||The nominal p-value is reported|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusting for geographic region (North America, South/central America, Western Europe, Eastern Europe, Asia/other).|Response Rate Difference = Upadacitinib - Methotrexate|||16.2|3.5|0.002
72491508|NCT02706873|144511065|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure. This endpoint was a ranked key secondary endpoint for EU/EMA regulatory purposes.|Response Rate Difference|11.6|||<|0.001|TWO_SIDED|95.0|5.4|17.8||The nominal p-value is reported|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusting for geographic region (North America, South/central America, Western Europe, Eastern Europe, Asia/other).|Response Rate Difference = Upadacitinib - Methotrexate|||17.8|5.4|<0.001
72517390|NCT03783442|144564631|SUPERIORITY||LS Mean Difference|-1.4||||0.3001|TWO_SIDED|95.0|-4.1|1.3|||Mixed Models Analysis|Two-sided p-value estimated from a mixed effect model|Based on a mixed effect model analysis with QLQ-OES18 scores until cycle 18 as the response variable, and treatment by study visit interaction, Baseline mean score, and randomization stratification factors as covariates.|Analysis of Change from Baseline in EORTC QLQ-OES18 Reflux Score at Cycle 6||1.3|-4.1|0.3001
72517391|NCT03783442|144564631|OTHER||LS Mean Difference|-1.9|||||TWO_SIDED|95.0|-3.9|0.2|||||Based on a mixed effect model analysis with QLQ-OES18 scores until cycle 18 as the response variable, and treatment by study visit interaction, Baseline mean score, and randomization stratification factors as covariates.|Analysis of Change from Baseline in EORTC QLQ-OES18 Pain Score at Cycle 6||0.2|-3.9|
72517392|NCT03783442|144564631|OTHER||LS Mean Difference|-0.4|||||TWO_SIDED|95.0|-2.1|1.4|||||Based on a mixed effect model analysis with QLQ-OES18 scores until cycle 18 as the response variable, and treatment by study visit interaction, Baseline mean score, and randomization stratification factors as covariates.|Analysis of Change from Baseline in EORTC QLQ-OES18 Index Score at Cycle 6||1.4|-2.1|
72517393|NCT03783442|144564632|OTHER||LS Mean Difference|3.3|||||TWO_SIDED|95.0|0.4|6.2|||||Based on a mixed effect model analysis, with QLQ-C30 scores until cycle 18 as the response variable, and treatment by study visit interaction, Baseline mean score, and randomization stratification factors as covariates.|Analysis of Change from Baseline in Global Health Status/QoL at Cycle 6||6.2|0.4|
72517394|NCT03783442|144564632|OTHER||LS Mean Difference|2.6|||||TWO_SIDED|95.0|0.0|5.1|||||Based on a mixed effect model analysis, with QLQ-C30 scores until cycle 18 as the response variable, and treatment by study visit interaction, Baseline mean score, and randomization stratification factors as covariates.|Analysis of Change from Baseline in Physical Functioning at Cycle 6||5.1|0.0|
72517395|NCT03783442|144564633|OTHER||LS Mean Difference|-1.4|||||TWO_SIDED|95.0|-4.7|1.9|||||Based on a mixed effect model analysis with QLQ-C30 scores until cycle 18 as the response variable, and treatment by study visit interaction, Baseline mean score, and randomization stratification factors as covariates.|||1.9|-4.7|
72491509|NCT02706873|144511066|SUPERIORITY||Response Rate Difference|18.5|||<|0.001|TWO_SIDED|95.0|12.1|24.9||The nominal p-value is reported|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusting for geographic region (North America, South/central America, Western Europe, Eastern Europe, Asia/other).|Response Rate Difference = Upadacitinib - Methotrexate|||24.9|12.1|<0.001
72517396|NCT04190186|144564636|SUPERIORITY||Mean Difference (Final Values)|0.49||||0.594|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.594
72624770|NCT01346592|144778965|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (H3N2 strain)|8.0|||||TWO_SIDED|95.0|2.2|15.6||||||No risk subjects.||15.6|2.2|
72405037|NCT01336738|144317499|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.22|STANDARD_ERROR_OF_MEAN|5.364||0.549|TWO_SIDED|95.0|-13.78|7.34||Two-sided p-value was calculated.|Mixed Models Analysis|||Week 1: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||7.34|-13.78|0.5490
72624771|NCT01346592|144778965|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (B strain)|4.0|||||TWO_SIDED|95.0|0.0|9.6||||||No risk subjects.||9.6|0|
72624772|NCT01346592|144778965|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (H1N1 strain)|-5.0|||||TWO_SIDED|95.0|-41.7|35.0||||||At risk subjects.||35|-41.7|
72624773|NCT01346592|144778965|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (H3N2 strain)|-9.0|||||TWO_SIDED|95.0|-38.6|23.4||||||At risk subjects.||23.4|-38.6|
72405038|NCT01336738|144317499|SUPERIORITY_OR_OTHER||LS Mean Difference|-15.07|STANDARD_ERROR_OF_MEAN|5.34||0.0051|TWO_SIDED|95.0|-25.58|-4.55||Two-sided p-value was calculated.|Mixed Models Analysis|||Week 1: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||-4.55|-25.58|0.0051
72405039|NCT01336738|144317499|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.43|STANDARD_ERROR_OF_MEAN|5.02||0.6291|TWO_SIDED|95.0|-12.31|7.46||Two-sided p-value was calculated.|Mixed Models Analysis|||Week 2: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||7.46|-12.31|0.6291
72405040|NCT01336738|144317499|SUPERIORITY_OR_OTHER||LS Mean Difference|3.87|STANDARD_ERROR_OF_MEAN|5.001||0.4396|TWO_SIDED|95.0|-5.98|13.72||Two-sided p-value was calculated.|Mixed Models Analysis|||Week 2: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||13.72|-5.98|0.4396
72517397|NCT00830960|144564672|SUPERIORITY_OR_OTHER||Least Square (LS) Mean Difference in PRU|-183.0|||<|0.0001|TWO_SIDED|95.0|-229.0|-137.0||"Linear mixed effects model: treatment, visit, treatment-by-visit interaction, gender, country as fixed effects, baseline PRU as covariate, participant as random effect was used.~Difference in PRU = prasugrel - clopidogrel."|Mixed Models Analysis|Kenward-Roger method was used to estimate denominator degrees of freedom for fixed effects. Invalid measurements excluded.||||-137|-229|<0.0001
72517398|NCT00830960|144564672|SUPERIORITY_OR_OTHER||LS Mean Difference in PRU|-139.0|||<|0.0001|TWO_SIDED|95.0|-177.0|-102.0||"Linear mixed effects model: treatment, visit, treatment-by-visit interaction, gender, country as fixed effects, baseline PRU as covariate, participant as random effect was used.~Difference in PRU = prasugrel - clopidogrel."|Mixed Models Analysis|Kenward-Roger method was used to estimate denominator degrees of freedom for fixed effects. Invalid measurements excluded.||||-102|-177|<0.0001
72517399|NCT00830960|144564673|SUPERIORITY_OR_OTHER||LS mean difference in PRU|-57.0||||0.0058|TWO_SIDED|95.0|-97.0|-17.0||"P-value for 30 minutes post-LD~Linear mixed effects model: treatment, visit, treatment-by-visit interaction, gender, country as fixed effects, baseline PRU as covariate, participant as random effect~Difference in PRU = prasugrel - clopidogrel."|Mixed Models Analysis|Kenward-Roger method was used to estimate the denominator degrees of freedom for fixed effects. Invalid measurements were excluded.||||-17|-97|0.0058
72517400|NCT00830960|144564673|SUPERIORITY_OR_OTHER||LS mean difference in PRU|-35.0||||0.0365|TWO_SIDED|95.0|-68.0|-2.0||"P-value for 30 minutes post-LD~Linear mixed effects model: treatment, visit, treatment-by-visit interaction, gender, country as fixed effects, baseline PRU as covariate, participant as random effect~Difference in PRU = prasugrel - clopidogrel"|Mixed Models Analysis|Kenward-Roger method was used to estimate the denominator degrees of freedom for fixed effects. Invalid measurements were excluded.||||-2|-68|0.0365
72517401|NCT00830960|144564673|SUPERIORITY_OR_OTHER||LS mean difference in PRU|-68.0||||0.0004|TWO_SIDED|95.0|-104.0|-32.0||"P-value for 30 minutes post-LD Linear mixed effects model: treatment, visit, treatment-by-visit interaction, gender, country as fixed effects, baseline PRU as covariate, participant as random effect~Difference in PRU = prasugrel - clopidogrel."|Mixed Models Analysis|Kenward-Roger method was used to estimate the denominator degrees of freedom for fixed effects. Invalid measurements were excluded.||||-32|-104|0.0004
72517402|NCT00830960|144564673|SUPERIORITY_OR_OTHER||LS mean difference in PRU|-160.0|||<|0.0001|TWO_SIDED|95.0|-211.0|-110.0||"P-value for 2 hours post-LD~Linear mixed effects model: treatment, visit, treatment-by-visit interaction, gender, country as fixed effects, baseline PRU as covariate, participant as random effect~Difference in PRU = prasugrel - clopidogrel."|Mixed Models Analysis|Kenward-Roger method was used to estimate the denominator degrees of freedom for fixed effects. Invalid measurements were excluded.||||-110|-211|<0.0001
72517403|NCT00830960|144564673|SUPERIORITY_OR_OTHER||LS mean difference in PRU|-115.0|||<|0.0001|TWO_SIDED|95.0|-156.0|-73.0||"P-value for 2 hours post-LD~Linear mixed effects model: treatment, visit, treatment-by-visit interaction, gender, country as fixed effects, baseline PRU as covariate, participant as random effect~Difference in PRU = prasugrel - clopidogrel."|Mixed Models Analysis|Kenward-Roger method was used to estimate the denominator degrees of freedom for fixed effects. Invalid measurements were excluded.||||-73|-156|<0.0001
72517404|NCT00830960|144564673|SUPERIORITY_OR_OTHER||LS mean difference in PRU|-171.0|||<|0.0001|TWO_SIDED|95.0|-216.0|-125.0||"P-value for 2 hours post-LD~Linear mixed effects model: treatment, visit, treatment-by-visit interaction, gender, country as fixed effects, baseline PRU as covariate, participant as random effect~Difference in PRU = prasugrel - clopidogrel."|Mixed Models Analysis|Kenward-Roger method was used to estimate the denominator degrees of freedom for fixed effects. Invalid measurements were excluded.||||-125|-216|<0.0001
72517405|NCT00830960|144564673|SUPERIORITY_OR_OTHER||LS mean difference in PRU|-212.0|||<|0.0001|TWO_SIDED|95.0|-259.0|-167.0||"P-value for 4 hours post-LD~Linear mixed effects model: treatment, visit, treatment-by-visit interaction, gender, country as fixed effects, baseline PRU as covariate, participant as random effect~Difference in PRU = prasugrel - clopidogrel."|Mixed Models Analysis|Kenward-Roger method was used to estimate the denominator degrees of freedom for fixed effects. Invalid measurements were excluded.||||-167|-259|<0.0001
72569279|NCT00444457|144669736|NON_INFERIORITY_OR_EQUIVALENCE|The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.|Difference in log-transformed GM|-0.01|||||TWO_SIDED|95.0|-0.13|0.11|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Additional serotypes - serotype 6A||0.11|-0.13|
72569280|NCT00444457|144669736|NON_INFERIORITY_OR_EQUIVALENCE|The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.|Difference in log-transformed GM|0.01|||||TWO_SIDED|95.0|-0.09|0.1|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Additional serotypes - serotype 7F||0.10|-0.09|
72569281|NCT00444457|144669736|NON_INFERIORITY_OR_EQUIVALENCE|The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.|Difference in log-transformed GM|-0.05|||||TWO_SIDED|95.0|-0.14|0.04|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Additional serotypes - serotype 7F||0.04|-0.14|
72569282|NCT00444457|144669736|NON_INFERIORITY_OR_EQUIVALENCE|The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.|Difference in log-transformed GM|-0.06|||||TWO_SIDED|95.0|-0.15|0.04|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Additional serotypes - serotype 7F||0.04|-0.15|
72491510|NCT02706873|144511066|OTHER||Response Rate Difference|22.9|||<|0.001|TWO_SIDED|95.0|16.4|29.5||The nominal p-value is reported|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusting for geographic region (North America, South/central America, Western Europe, Eastern Europe, Asia/other).|Response Rate Difference = Upadacitinib - Methotrexate|||29.5|16.4|<0.001
72491511|NCT02706873|144511067|SUPERIORITY||Response Rate Difference|20.3|||<|0.001|TWO_SIDED|95.0|13.2|27.3||The nominal p-value is reported|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusting for geographic region (North America, South/central America, Western Europe, Eastern Europe, Asia/other).|Response Rate Difference = Upadacitinib - Methotrexate|||27.3|13.2|<0.001
72491512|NCT02706873|144511067|SUPERIORITY||Response Rate Difference|19.4|||<|0.001|TWO_SIDED|95.0|12.3|26.5||The nominal p-value is reported|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusting for geographic region (North America, South/central America, Western Europe, Eastern Europe, Asia/other).|Response Rate Difference = Upadacitinib - Methotrexate|||26.5|12.3|<0.001
72491513|NCT02706873|144511068|SUPERIORITY||Response Rate Difference|26.0|||<|0.001|TWO_SIDED|95.0|19.1|33.0||The nominal p-value is reported|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusting for geographic region (North America, South/central America, Western Europe, Eastern Europe, Asia/other).|Response Rate Difference = Upadacitinib - Methotrexate|||33.0|19.1|<0.001
72491514|NCT02706873|144511068|SUPERIORITY||Response Rate Difference|31.2|||<|0.001|TWO_SIDED|95.0|24.2|38.2||The nominal p-value is reported|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusting for geographic region (North America, South/central America, Western Europe, Eastern Europe, Asia/other).|Response Rate Difference = Upadacitinib - Methotrexate|||38.2|24.2|<0.001
72491515|NCT02706873|144511069|SUPERIORITY|For the Japan sub-study, no multiplicity adjustments were applied and only nominal p-values were provided for all efficacy analyses.|Response Rate Difference|28.3||||0.004|TWO_SIDED|95.0|7.7|48.9|||Chi-squared||Response Rate Difference = Upadacitinib - Methotrexate|||48.9|7.7|0.004
72491516|NCT02706873|144511069|SUPERIORITY||Response Rate Difference|28.0||||0.022|TWO_SIDED|95.0|5.3|50.7|||Chi-squared||Response Rate Difference = Upadacitinib - Methotrexate|||50.7|5.3|0.022
72491517|NCT02706873|144511069|SUPERIORITY||Response Rate Difference|21.4||||0.086|TWO_SIDED|95.0|-2.4|45.2|||Chi-squared||Response Rate Difference = Upadacitinib - Methotrexate|||45.2|-2.4|0.086
72491518|NCT02706873|144511070|SUPERIORITY||Response Rate Difference|38.6|||<|0.001|TWO_SIDED|95.0|18.6|58.5|||Chi-squared||Response Rate Difference = Upadacitinib - Methotrexate|||58.5|18.6|<0.001
72491519|NCT02706873|144511070|SUPERIORITY||Response Rate Difference|45.2|||<|0.001|TWO_SIDED|95.0|21.8|68.6|||Chi-squared||Response Rate Difference = Upadacitinib - Methotrexate|||68.6|21.8|<0.001
72491520|NCT02706873|144511070|SUPERIORITY||Response Rate Difference|50.0|||<|0.001|TWO_SIDED|95.0|27.4|72.6|||Chi-squared||Response Rate Difference = Upadacitinib - Methotrexate|||72.6|27.4|<0.001
72491521|NCT02706873|144511071|SUPERIORITY||Response Rate Difference|34.5|||<|0.001|TWO_SIDED|95.0|22.0|47.1|||Chi-squared||Response Rate Difference = Upadacitinib - Methotrexate|||47.1|22.0|<0.001
72491522|NCT02706873|144511071|SUPERIORITY||Response Rate Difference|51.9|||<|0.001|TWO_SIDED|95.0|33.0|70.7|||Chi-squared||Response Rate Difference = Upadacitinib - Methotrexate|||70.7|33.0|<0.001
72491523|NCT02706873|144511071|SUPERIORITY||Response Rate Difference|64.3|||<|0.001|TWO_SIDED|95.0|46.5|82.0|||Chi-squared||Response Rate Difference = Upadacitinib - Methotrexate|||82.0|46.5|<0.001
72491524|NCT02706873|144511072|SUPERIORITY||LS Mean Difference|-1.43|||<|0.001|TWO_SIDED|95.0|-1.92|-0.95|||ANOVA|ANOVA model with Baseline value as covariate.|Difference = Upadacitinib - Methotrexate|||-0.95|-1.92|<0.001
72491525|NCT02706873|144511072|SUPERIORITY||LS Mean Difference|-1.86|||<|0.001|TWO_SIDED|95.0|-2.42|-1.3|||ANOVA|ANOVA model with Baseline value as covariate.|Difference = Upadacitinib - Methotrexate|||-1.30|-2.42|<0.001
72491526|NCT02706873|144511072|SUPERIORITY||LS Mean Difference|-1.92|||<|0.001|TWO_SIDED|95.0|-2.48|-1.36|||ANOVA|ANOVA model with Baseline value as covariate.|Difference = Upadacitinib - Methotrexate|||-1.36|-2.48|<0.001
72569283|NCT00444457|144669736|NON_INFERIORITY_OR_EQUIVALENCE|The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.|Difference in log-transformed GM|-0.08|||||TWO_SIDED|95.0|-0.19|0.03|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Additional serotypes - serotype 19A||0.03|-0.19|
72569284|NCT00444457|144669736|NON_INFERIORITY_OR_EQUIVALENCE|The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.|Difference in log-transformed GM|-0.02|||||TWO_SIDED|95.0|-0.12|0.09|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Additional serotypes - serotype 19A||0.09|-0.12|
72569285|NCT00444457|144669736|NON_INFERIORITY_OR_EQUIVALENCE|The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.|Difference in log-transformed GM|0.06|||||TWO_SIDED|95.0|-0.05|0.17|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Additional serotypes - serotype 19A||0.17|-0.05|
72569286|NCT00444457|144669737|NON_INFERIORITY_OR_EQUIVALENCE|For each of the 5 concomitant antigens (tetanus toxoid, poliovirus Type 1, 2, and 3, and hepatitis b antibodies), non-inferiority was shown if the lower limit of the 2-sided 95% CI, computed using the Chan and Zhang procedure for the difference in proportions, is greater than -10%.|Difference|-0.1|||||TWO_SIDED|95.0|-3.3|3.0|||||Exact 2-sided CI for difference in proportions (combined 13vPnC, 7vPnC) expressed as a percentage.|Tetanus toxoid: Difference in proportions (combined 13vPnC, 7vPnC) expressed as a percentage.||3.0|-3.3|
72569287|NCT00444457|144669738|NON_INFERIORITY_OR_EQUIVALENCE|For each of the 5 concomitant antigens (tetanus toxoid, poliovirus Type 1, 2, and 3, and hepatitis b antibodies), non-inferiority was shown if the lower limit of the 2-sided 95% CI, computed using the Chan and Zhang procedure for the difference in proportions, is greater than -10%.|Difference|0.0|||||TWO_SIDED|95.0|-2.1|2.0|||||Exact 2-sided CI for difference in proportions (combined 13vPnC, 7vPnC) expressed as a percentage.|Poliovirus type 1: Difference in proportions (combined 13vPnC, 7vPnC) expressed as a percentage.||2.0|-2.1|
72569288|NCT00444457|144669738|NON_INFERIORITY_OR_EQUIVALENCE|For each of the 5 concomitant antigens (tetanus toxoid, poliovirus Type 1, 2, and 3, and hepatitis b antibodies), non-inferiority was shown if the lower limit of the 2-sided 95% CI, computed using the Chan and Zhang procedure for the difference in proportions, is greater than -10%.|Difference|-0.6|||||TWO_SIDED|95.0|-3.4|2.0|||||Exact 2-sided CI for difference in proportions (combined 13vPnC, 7vPnC) expressed as a percentage.|Poliovirus type 2: Difference in proportions (combined 13vPnC, 7vPnC) expressed as a percentage.||2.0|-3.4|
72569289|NCT00444457|144669738|NON_INFERIORITY_OR_EQUIVALENCE|For each of the 5 concomitant antigens (tetanus toxoid, poliovirus Type 1, 2, and 3, and hepatitis b antibodies), non-inferiority was shown if the lower limit of the 2-sided 95% CI, computed using the Chan and Zhang procedure for the difference in proportions, is greater than -10%.|Difference|0.5|||||TWO_SIDED|95.0|-1.5|3.0|||||Exact 2-sided CI for difference in proportions (combined 13vPnC, 7vPnC) expressed as a percentage.|Poliovirus type 3: Difference in proportions (combined 13vPnC, 7vPnC) expressed as a percentage.||3.0|-1.5|
72569290|NCT00444457|144669739|NON_INFERIORITY_OR_EQUIVALENCE|For each of the 5 concomitant antigens (tetanus toxoid, poliovirus Type 1, 2, and 3, and hepatitis b antibodies), non-inferiority was shown if the lower limit of the 2-sided 95% CI, computed using the Chan and Zhang procedure for the difference in proportions, is greater than -10%.|Difference|0.0|||||TWO_SIDED|95.0|-2.4|2.2|||||Exact 2-sided CI for difference in proportions (combined 13vPnC, 7vPnC) expressed as a percentage.|Hepatitis B: Difference in proportions (combined 13vPnC, 7vPnC) expressed as a percentage.||2.2|-2.4|
72569291|NCT00444457|144669740|NON_INFERIORITY_OR_EQUIVALENCE|Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|2.0|||||TWO_SIDED|95.0|-0.51|4.75||||||Common serotypes - serotype 4||4.75|-0.51|
72569292|NCT00444457|144669740|NON_INFERIORITY_OR_EQUIVALENCE|Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|-0.9|||||TWO_SIDED|95.0|-3.09|1.1||||||Common serotypes - serotype 4||1.10|-3.09|
72569293|NCT00444457|144669740|NON_INFERIORITY_OR_EQUIVALENCE|Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|-2.9|||||TWO_SIDED|95.0|-5.58|-0.58||||||Common serotypes - serotype 4||-0.58|-5.58|
72491527|NCT02706873|144511073|SUPERIORITY||LS Mean Difference|-0.54|||<|0.001|TWO_SIDED|95.0|-0.75|-0.34|||ANOVA|ANOVA model with Baseline value as covariate.|Difference = Upadacitinib - Methotrexate|||-0.34|-0.75|<0.001
72491528|NCT02706873|144511073|SUPERIORITY||LS Mean Difference|-0.75|||<|0.001|TWO_SIDED|95.0|-0.99|-0.51|||ANOVA|ANOVA model with Baseline value as covariate.|Difference = Upadacitinib - Methotrexate|||-0.51|-0.99|<0.001
72491529|NCT02706873|144511073|SUPERIORITY||LS Mean Difference|-0.75|||<|0.001|TWO_SIDED|95.0|-0.99|-0.51|||ANOVA|ANOVA model with Baseline value as covariate.|Difference = Upadacitinib - Methotrexate|||-0.51|-0.99|<0.001
72491530|NCT02706873|144511074|SUPERIORITY||LS Mean Difference|5.97|||<|0.001|TWO_SIDED|95.0|3.15|8.8|||ANOVA|ANOVA model with Baseline value as covariate.|Difference = Upadacitinib - Methotrexate|||8.80|3.15|<0.001
72569294|NCT00444457|144669740|NON_INFERIORITY_OR_EQUIVALENCE|Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|5.3|||||TWO_SIDED|95.0|1.55|9.19||||||Common serotypes - serotype 6B||9.19|1.55|
72624774|NCT01346592|144778965|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (B strain)|0.0|||||TWO_SIDED|95.0|-26.9|31.0||||||At risk subjects.||31|-26.9|
72624775|NCT01346592|144778966|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT Ratio (H1N1 strain)|2.29|||||TWO_SIDED|95.0|1.91|2.76||||||No risk subjects.||2.76|1.91|
72405041|NCT01336738|144317499|SUPERIORITY_OR_OTHER||LS Mean Difference|-6.56|STANDARD_ERROR_OF_MEAN|5.03||0.1934|TWO_SIDED|95.0|-16.46|3.34||Two-sided p-value was calculated.|Mixed Models Analysis|||Week 2: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||3.34|-16.46|0.1934
72405042|NCT01336738|144317499|SUPERIORITY_OR_OTHER||LS Mean Difference|-17.32|STANDARD_ERROR_OF_MEAN|5.039||0.0007|TWO_SIDED|95.0|-27.24|-7.4||Two-sided p-value was calculated.|Mixed Models Analysis|||Week 2: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||-7.40|-27.24|0.0007
72491531|NCT02706873|144511074|SUPERIORITY||LS Mean Difference|7.92|||<|0.001|TWO_SIDED|95.0|4.66|11.19|||ANOVA|ANOVA model with Baseline value as covariate.|Difference = Upadacitinib - Methotrexate|||11.19|4.66|<0.001
72491532|NCT02706873|144511074|SUPERIORITY||LS Mean Difference|6.76|||<|0.001|TWO_SIDED|95.0|3.33|10.2|||ANOVA|ANOVA model with Baseline value as covariate.|Difference = Upadacitinib - Methotrexate|||10.20|3.33|<0.001
72491533|NCT02706873|144511075|SUPERIORITY||Response Rate Difference|51.2|||<|0.001|TWO_SIDED|95.0|32.5|70.0|||Chi-squared||Response Rate Difference = Upadacitinib - Methotrexate|||70.0|32.5|<0.001
72491534|NCT02706873|144511075|SUPERIORITY||Response Rate Difference|59.9|||<|0.001|TWO_SIDED|95.0|38.8|81.1|||Chi-squared||Response Rate Difference = Upadacitinib - Methotrexate|||81.1|38.8|<0.001
72491535|NCT02706873|144511075|SUPERIORITY||Response Rate Difference|60.7|||<|0.001|TWO_SIDED|95.0|39.9|81.5|||Chi-squared||Response Rate Difference = Upadacitinib - Methotrexate|||81.5|39.9|<0.001
72517406|NCT00830960|144564674|SUPERIORITY_OR_OTHER||LS Mean Difference in PRU|-119.0|||<|0.0001|TWO_SIDED|95.0|-166.0|-73.0||"P-value for 30 days. A linear mixed effects model including treatment, visit, treatment-by-visit interaction, gender, country as fixed effects, baseline PRU as covariate, participant as random effect~Difference in PRU was prasugrel - clopidogrel."|LS Mean Difference in PRU|Kenward-Roger method was used to estimate the denominator degrees of freedom for fixed effects. Invalid measurements were excluded.||||-73|-166|<0.0001
72517407|NCT00830960|144564674|SUPERIORITY_OR_OTHER||LS Mean Difference in PRU|-113.0|||<|0.0001|TWO_SIDED|95.0|-154.0|-73.0||"P-value for 90 days. A linear mixed effects model including treatment, visit, treatment-by-visit interaction, gender, country as fixed effects, baseline PRU as covariate, participant as random effect~Difference in PRU was prasugrel - clopidogrel."|Mixed Models Analysis|Kenward-Roger method was used to estimate the denominator degrees of freedom for fixed effects. Invalid measurements were excluded.||||-73|-154|<0.0001
72517408|NCT00830960|144564674|SUPERIORITY_OR_OTHER||LS Mean Difference in PRU|-85.0|||<|0.0001|TWO_SIDED|95.0|-121.0|-48.0||"P-value for 90 days. A linear mixed effects model including treatment, visit, treatment-by-visit interaction, gender, country as fixed effects, baseline PRU as covariate, participant as random effect~Difference in PRU was prasugrel - clopidogrel."|Mixed Models Analysis|Kenward-Roger method was used to estimate the denominator degrees of freedom for fixed effects. Invalid measurements were excluded.||||-48|-121|<0.0001
72517409|NCT00830960|144564674|SUPERIORITY_OR_OTHER||LS Mean Difference in PRU|-35.0||||0.0647|TWO_SIDED|95.0|-72.0|2.0||"P-value for 90 days. A linear mixed effects model including treatment, visit, treatment-by-visit interaction, gender, country as fixed effects, baseline PRU as covariate, participant as random effect~Difference in PRU was prasugrel - clopidogrel."|Mixed Models Analysis|Kenward-Roger method was used to estimate the denominator degrees of freedom for fixed effects. Invalid measurements were excluded.||||2|-72|0.0647
72517410|NCT00830960|144564674|SUPERIORITY_OR_OTHER||LS Mean Difference in PRU|-100.0|||<|0.0001|TWO_SIDED|95.0|-143.0|-57.0||"P-value for 90 days. A linear mixed effects model including treatment, visit, treatment-by-visit interaction, gender, country as fixed effects, baseline PRU as covariate, participant as random effect~Difference in PRU was prasugrel - clopidogrel."|Mixed Models Analysis|Kenward-Roger method was used to estimate the denominator degrees of freedom for fixed effects. Invalid measurements were excluded.||||-57|-143|<0.0001
72517411|NCT00830960|144564675|SUPERIORITY_OR_OTHER||LS Mean Difference in Percent Inhibition|15.0||||0.0072|TWO_SIDED|95.0|4.0|27.0||"P-value for 30 minutes post-LD~Linear mixed effects model: treatment, visit (0.5 hours to 4 hours), treatment-by-visit interaction, gender, country as fixed effects, participant as random effect~Difference in PRU = prasugrel - clopidogrel."|Mixed Models Analysis|Kenward-Roger method was used to estimate the denominator degrees of freedom for fixed effects. Invalid measurements were excluded.||||27|4|0.0072
72517412|NCT00830960|144564675|SUPERIORITY_OR_OTHER||LS Mean Difference in Percent Inhibition|9.0||||0.0647|TWO_SIDED|95.0|-1.0|18.0||"P-value for 30 minutes post-LD Linear mixed effects model: treatment, visit (0.5 hours to 4 hours), treatment-by-visit interaction, gender, country as fixed effects, participant as random effect~Difference in PRU = prasugrel - clopidogrel."|Mixed Models Analysis|Kenward-Roger method was used to estimate the denominator degrees of freedom for fixed effects. Invalid measurements were excluded.||||18|-1|0.0647
72517413|NCT00830960|144564675|SUPERIORITY_OR_OTHER||LS Mean Difference in Percent Inhibition|11.0||||0.0054|TWO_SIDED|95.0|3.0|19.0||"P-value for 30 minutes post-LD~Linear mixed effects model: treatment, visit (0.5 hours to 4 hours), treatment-by-visit interaction, gender, country as fixed effects, participant as random effect~Difference in PRU = prasugrel - clopidogrel."|Mixed Models Analysis|Kenward-Roger method was used to estimate the denominator degrees of freedom for fixed effects. Invalid measurements were excluded.||||19|3|0.0054
72405043|NCT01336738|144317499|SUPERIORITY_OR_OTHER||LS Mean Difference|3.13|STANDARD_ERROR_OF_MEAN|5.201||0.5479|TWO_SIDED|95.0|-7.11|13.37||Two-sided p-value was calculated.|Mixed Models Analysis|||Week 4: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||13.37|-7.11|0.5479
72491536|NCT02706873|144511076|SUPERIORITY||Response Rate Difference|49.4|||<|0.001|TWO_SIDED|95.0|30.6|68.3|||Chi-squared||Response Rate Difference = Upadacitinib - Methotrexate|||68.3|30.6|<0.001
72491537|NCT02706873|144511076|SUPERIORITY||Response Rate Difference|52.5|||<|0.001|TWO_SIDED|95.0|30.2|74.8|||Chi-squared||Response Rate Difference = Upadacitinib - Methotrexate|||74.8|30.2|<0.001
72405044|NCT01336738|144317499|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.14|STANDARD_ERROR_OF_MEAN|5.209||0.4276|TWO_SIDED|95.0|-14.39|6.12||Two-sided p-value was calculated.|Mixed Models Analysis|||Week 4: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||6.12|-14.39|0.4276
72405045|NCT01336738|144317499|SUPERIORITY_OR_OTHER||LS Mean Difference|-7.38|STANDARD_ERROR_OF_MEAN|5.235||0.1596|TWO_SIDED|95.0|-17.69|2.92||Two-sided p-value was calculated.|Mixed Models Analysis|||Week 4: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||2.92|-17.69|0.1596
72491538|NCT02706873|144511076|SUPERIORITY||Response Rate Difference|64.3|||<|0.001|TWO_SIDED|95.0|44.2|84.3|||Chi-squared||Response Rate Difference = Upadacitinib - Methotrexate|||84.3|44.2|<0.001
72491539|NCT02706873|144511077|SUPERIORITY||LS Mean Difference|-1.69||||0.063|TWO_SIDED|95.0|-3.47|0.09|||ANOVA|ANOVA model with Baseline value as covariate.|Difference = Upadacitinib - Methotrexate|||0.09|-3.47|0.063
72491540|NCT02706873|144511077|SUPERIORITY||LS Mean Difference|-2.4||||0.022|TWO_SIDED|95.0|-4.45|-0.35|||ANOVA|ANOVA model with Baseline value as covariate.|Difference = Upadacitinib - Methotrexate|||-0.35|-4.45|0.022
72491541|NCT02706873|144511077|SUPERIORITY||LS Mean Difference|-2.45||||0.022|TWO_SIDED|95.0|-4.54|-0.35|||ANOVA|ANOVA model with Baseline value as covariate.|Difference = Upadacitinib - Methotrexate|||-0.35|-4.54|0.022
72491542|NCT02706873|144511078|SUPERIORITY||Response Rate Difference|36.2||||0.001|TWO_SIDED|95.0|14.4|58.0|||Chi-squared||Response Rate Difference = Upadacitinib - Methotrexate|||58.0|14.4|0.001
72491543|NCT02706873|144511078|SUPERIORITY||Response Rate Difference|34.6||||0.01|TWO_SIDED|95.0|10.2|59.0|||Chi-squared||Response Rate Difference = Upadacitinib - Methotrexate|||59.0|10.2|0.010
72491544|NCT02706873|144511078|SUPERIORITY||Response Rate Difference|33.0||||0.016|TWO_SIDED|95.0|7.9|58.1|||Chi-squared||Response Rate Difference = Upadacitinib - Methotrexate|||58.1|7.9|0.016
72491545|NCT05051904|144511079|OTHER||Adjusted Hazard Ratio|0.5|||<|0.0001|TWO_SIDED|95.0|0.402|0.622|||Regression, Cox|Cox proportional hazard model with s-IPTW. 'Treatment' is the only Independent variable used to estimate the hazard ratios.|Hazard ratio \<1 favors Dabigatran.|||0.622|0.402|<0.0001
72491546|NCT05051904|144511079|OTHER||Adjusted Hazard Ratio|0.784||||0.0004|TWO_SIDED|95.0|0.686|0.896|||Regression, Cox|Cox proportional hazard model with s-IPTW. 'Treatment' is the only Independent variable used to estimate the hazard ratios.|Hazard ratio \<1 favors Rivaroxaban.|||0.896|0.686|0.0004
72405046|NCT01336738|144317499|SUPERIORITY_OR_OTHER||LS Mean Difference|-22.83|STANDARD_ERROR_OF_MEAN|5.198|<|0.0001|TWO_SIDED|95.0|-33.06|-12.6||Two-sided p-value was calculated.|Mixed Models Analysis|||Week 4: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||-12.60|-33.06|<0.0001
72491547|NCT05051904|144511079|OTHER||Adjusted Hazard Ratio|0.637|||<|0.0001|TWO_SIDED|95.0|0.514|0.791|||Regression, Cox|Cox proportional hazard model with s-IPTW. 'Treatment' is the only Independent variable used to estimate the hazard ratios.|Hazard ratio \<1 favors Dabigatran.|||0.791|0.514|<0.0001
72491548|NCT05051904|144511080|OTHER||Adjusted Hazard Ratio|0.78|||<|0.0001|TWO_SIDED|95.0|0.714|0.851|||Regression, Cox|Cox proportional hazard model with s-IPTW. 'Treatment' is the only Independent variable used to estimate the hazard ratios.|Hazard ratio \<1 favors Dabigatran.|||0.851|0.714|<0.0001
72491549|NCT05051904|144511080|OTHER||Adjusted Hazard Ratio|0.827|||<|0.0001|TWO_SIDED|95.0|0.777|0.88|||Regression, Cox|Cox proportional hazard model with s-IPTW. 'Treatment' is the only Independent variable used to estimate the hazard ratios.|Hazard ratio\<1 favors Rivaroxaban|||0.88|0.777|<0.0001
72491550|NCT02599961|144511082|SUPERIORITY||LS Mean|-82.73|STANDARD_ERROR_OF_MEAN|11.363|<|0.0001|TWO_SIDED|95.0|-105.0|-60.46||From the GEE model which includes the reduction from baseline for each visit period as the response variable, baseline as covariates, visit period as a factor, identity link function and exchangeable within subject working correlation matrix.|generalized estimating equation (GEE)|||Month 0-3||-60.46|-105.00|< 0.0001
72491551|NCT02599961|144511082|SUPERIORITY||LS mean|-54.91|STANDARD_ERROR_OF_MEAN|16.097||0.0006|TWO_SIDED|95.0|-86.46|-23.36||From the GEE model which includes the reduction from baseline for each visit period as the response variable, baseline as covariates, visit period as a factor, identity link function and exchangeable within subject working correlation matrix.|GEE model|||Month 4-6||-23.36|-86.46|0.0006
72491552|NCT02599961|144511082|SUPERIORITY||LS Mean|-52.53|STANDARD_ERROR_OF_MEAN|16.882||0.0019|TWO_SIDED|95.0|-85.62|-19.45||From the GEE model which includes the reduction from baseline for each visit period as the response variable, baseline as covariates, visit period as a factor, identity link function and exchangeable within subject working correlation matrix.|GEE model|||Month 7-9||-19.45|-85.62|0.0019
72491553|NCT02599961|144511082|SUPERIORITY||LS Mean|-82.65|STANDARD_ERROR_OF_MEAN|15.55|<|0.0001|TWO_SIDED|95.0|-113.13|-52.17||From the GEE model which includes the reduction from baseline for each visit period as the response variable, baseline as covariates, visit period as a factor, identity link function and exchangeable within subject working correlation matrix.|GEE model|||Month 10-12||-52.17|-113.13|< 0.0001
72405047|NCT01336738|144317499|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|5.855||0.8509|TWO_SIDED|95.0|-12.63|10.43||Two-sided p-value was calculated.|Mixed Models Analysis|||Week 8: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||10.43|-12.63|0.8509
72491554|NCT00794677|144511123|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.252|STANDARD_ERROR_OF_MEAN|0.112||0.03||95.0|||||ANOVA|||Statistical significance was determined for a standard two-period crossover design using JMP software (Version 5.0, SAS Institute. Cary, NC).||||0.03
72491555|NCT00794677|144511124|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.273|STANDARD_ERROR_OF_MEAN|0.102||0.01||95.0|||||ANOVA|||||||0.01
72624776|NCT01346592|144778966|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT Ratio (H3N2 strain)|1.6|||||TWO_SIDED|95.0|1.35|1.89||||||No risk subjects.||1.89|1.35|
72491556|NCT00794677|144511125|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.048|STANDARD_ERROR_OF_MEAN|0.089||0.6||95.0|||||ANOVA|||||||0.60
72491557|NCT00794677|144511126|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.209|STANDARD_ERROR_OF_MEAN|0.47||0.67||95.0|||||ANOVA|||||||0.67
72491558|NCT00794677|144511127|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.15|STANDARD_ERROR_OF_MEAN|0.14||0.3||95.0|||||ANOVA|||||||0.30
72491559|NCT00794677|144511128|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-15.412|STANDARD_ERROR_OF_MEAN|1.569|<|0.0001|TWO_SIDED|95.0|||||ANOVA|||||||<0.0001
72491560|NCT00794677|144511129|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-21.846|STANDARD_ERROR_OF_MEAN|2.866|<|1e-07|TWO_SIDED|95.0|||||ANOVA|||||||<0.0000001
72491561|NCT00794677|144511130|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|5.397|STANDARD_ERROR_OF_MEAN|1.893||0.009|TWO_SIDED|95.0|||||ANOVA|||||||0.009
72491562|NCT00794677|144511131|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-21.353|STANDARD_ERROR_OF_MEAN|2.22|<|1e-07|TWO_SIDED|95.0|||||ANOVA|||||||<0.0000001
72491563|NCT00609791|144511157|SUPERIORITY||Slope|0.011|STANDARD_ERROR_OF_MEAN|0.0057||0.055|TWO_SIDED||||||Regression, Linear|||Linear regression of ln AUC24 on age in years||||0.055
72491564|NCT00609791|144511157|SUPERIORITY||Slope|1.17|STANDARD_ERROR_OF_MEAN|0.45||0.013|TWO_SIDED||||||Regression, Linear|||Linear regression of ln AUC24 on chemotherapy toxicity risk score||||0.013
72491565|NCT00609791|144511158|SUPERIORITY||Slope|-0.0074|STANDARD_ERROR_OF_MEAN|0.0063||0.25|TWO_SIDED||||||Regression, Linear|||Linear regression of ln CL on age in years||||0.25
72491566|NCT00609791|144511158|SUPERIORITY||Slope|-0.96|STANDARD_ERROR_OF_MEAN|0.44||0.04|TWO_SIDED||||||Regression, Linear|||Linear regression of ln CL versus chemotherapy toxicity risk score||||0.04
72491567|NCT00609791|144511159|OTHER|||||||0.041|||||||Fisher Exact|||||||0.041
72491568|NCT00609791|144511162|SUPERIORITY||Mean Difference (Final Values)|-4.89||||0.38|TWO_SIDED|95.0|-16.5|6.7|||t-test, 2 sided|||Difference in age based on whether there was need for a dose reduction.||6.7|-16.5|.38
72517414|NCT00830960|144564675|SUPERIORITY_OR_OTHER||LS Mean Difference in Percent Inhibition|51.0|||<|0.0001|TWO_SIDED|95.0|36.0|66.0||"P-value for 2 hours post-LD~Linear mixed effects model: treatment, visit (0.5 hours to 4 hours), treatment-by-visit interaction, gender, country as fixed effects, participant as random effect~Difference in PRU = prasugrel - clopidogrel."|Mixed Models Analysis|Kenward-Roger method was used to estimate the denominator degrees of freedom for fixed effects. Invalid measurements were excluded.||||66|36|<0.0001
72517415|NCT00830960|144564675|SUPERIORITY_OR_OTHER||LS Mean Difference in Percent Inhibition|36.0|||<|0.0001|TWO_SIDED|95.0|23.0|48.0||"P-value for 2 hours post-LD~Linear mixed effects model: treatment, visit (0.5 hours to 4 hours), treatment-by-visit interaction, gender, country as fixed effects, participant as random effect~Difference in PRU = prasugrel - clopidogrel."|Mixed Models Analysis|Kenward-Roger method was used to estimate the denominator degrees of freedom for fixed effects. Invalid measurements were excluded.||||48|23|<0.0001
72517416|NCT00830960|144564675|SUPERIORITY_OR_OTHER||LS Mean Difference in Percent Inhibition|49.0|||<|0.0001|TWO_SIDED|95.0|36.0|61.0||"P-value for 2 hours post-LD~Linear mixed effects model: treatment, visit (0.5 hours to 4 hours), treatment-by-visit interaction, gender, country as fixed effects, participant as random effect~Difference in PRU = prasugrel - clopidogrel."|Mixed Models Analysis|Kenward-Roger method was used to estimate the denominator degrees of freedom for fixed effects. Invalid measurements were excluded.||||61|36|<0.0001
72405048|NCT01336738|144317499|SUPERIORITY_OR_OTHER||LS Mean Difference|-8.53|STANDARD_ERROR_OF_MEAN|5.913||0.1505|TWO_SIDED|95.0|-20.17|3.12||Two-sided p-value was calculated.|Mixed Models Analysis|||Week 8: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||3.12|-20.17|0.1505
72491569|NCT00609791|144511162|SUPERIORITY||Mean Difference (Final Values)|0.058||||0.76|TWO_SIDED|95.0|-0.33|0.44|||t-test, 2 sided|||Difference in AUC24 based on the need of a dose reduction.||0.44|-0.33|0.76
72491570|NCT00609791|144511162|SUPERIORITY||Mean Difference (Final Values)|-0.063||||0.75|TWO_SIDED|95.0|-0.49|0.36|||t-test, 2 sided|||Difference in clearance based on whether there was a need for dose reduction.||0.36|-0.49|0.75
72491571|NCT00609791|144511163|SUPERIORITY||Mean Difference (Final Values)|5.81||||0.15|TWO_SIDED|95.0|-2.3|13.9|||t-test, 2 sided|||Difference in age based on whether there was need for a dose omission.||13.9|-2.3|0.15
72491572|NCT00609791|144511163|SUPERIORITY||Mean Difference (Final Values)|-0.079||||0.61|TWO_SIDED|95.0|-0.39|0.23|||t-test, 2 sided|||Difference in AUC24 based on whether there was need for a dose omission.||0.23|-0.39|0.61
72491573|NCT00609791|144511163|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.51|TWO_SIDED|95.0|-0.22|0.42|||t-test, 2 sided|||Difference in clearance based on whether there was a need for a dose omission.||0.42|-0.22|0.51
72491574|NCT00609791|144511164|SUPERIORITY||Mean Difference (Final Values)|1.68||||0.75|TWO_SIDED|95.0|-9.3|12.7|||t-test, 2 sided|||Difference in age based on whether a participant experienced grade 3 toxicity.||12.7|-9.3|0.75
72491575|NCT00609791|144511164|SUPERIORITY||Mean Difference (Final Values)|0.34||||0.13|TWO_SIDED|95.0|-0.12|0.81|||t-test, 2 sided|||Difference in AUC based on whether a participant experienced grade 3 toxicity.||0.81|-0.12|0.13
72491576|NCT00609791|144511164|SUPERIORITY||Mean Difference (Final Values)|-0.21||||0.34|TWO_SIDED|95.0|-0.67|0.25|||t-test, 2 sided|||Difference in clearance based on whether a participant experienced grade 3 toxicity.||0.25|-0.67|0.34
72491577|NCT00623480|144511205|SUPERIORITY_OR_OTHER||Ratio (On-Demand vs. Prophylaxis)|14.7|||<|0.0001|TWO_SIDED|95.0|8.1|26.5|||Negative Binomial Regression Model|Adjusted for time of follow-up||||26.5|8.1|<0.0001
72569295|NCT00444457|144669740|NON_INFERIORITY_OR_EQUIVALENCE|Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|0.4|||||TWO_SIDED|95.0|-2.77|3.66||||||Common serotypes - serotype 6B||3.66|-2.77|
72569296|NCT00444457|144669740|NON_INFERIORITY_OR_EQUIVALENCE|Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|-4.9|||||TWO_SIDED|95.0|-8.82|-1.1||||||Common serotypes - serotype 6B||-1.10|-8.82|
72569297|NCT00444457|144669740|NON_INFERIORITY_OR_EQUIVALENCE|Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|-0.2|||||TWO_SIDED|95.0|-3.13|2.83||||||Common serotypes - serotype 9V||2.83|-3.13|
72569298|NCT00444457|144669740|NON_INFERIORITY_OR_EQUIVALENCE|Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|-1.1|||||TWO_SIDED|95.0|-3.97|1.73||||||Common serotypes - serotype 9V||1.73|-3.97|
72491578|NCT00623480|144511206|SUPERIORITY_OR_OTHER||estimated diff (prohylaxis vs. OD)|-0.17||||0.6614|TWO_SIDED|95.0|-0.92|0.59|||Based on cLDA model|Adjusted for presence/absence of target joint and prior 6 month bleeding frequency||||0.59|-0.92|0.6614
72569299|NCT00444457|144669740|NON_INFERIORITY_OR_EQUIVALENCE|Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|-0.9|||||TWO_SIDED|95.0|-3.81|1.88||||||Common serotypes - serotype 9V||1.88|-3.81|
72569300|NCT00444457|144669740|NON_INFERIORITY_OR_EQUIVALENCE|Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|0.3|||||TWO_SIDED|95.0|-1.27|1.95||||||Common serotypes - serotype 14||1.95|-1.27|
72491579|NCT00623480|144511207|SUPERIORITY_OR_OTHER||estimated diff (prohylaxis vs. OD)|-0.94||||0.0072|TWO_SIDED|95.0|-1.61|-0.26|||Based on cLDA model|Adjusted for presence/absence of target joint and prior 6 month bleeding frequency||||-0.26|-1.61|0.0072
72517417|NCT00830960|144564675|SUPERIORITY_OR_OTHER||LS Mean Difference in Percent Inhibition|62.0|||<|0.0001|TWO_SIDED|95.0|47.0|76.0||"P-value for 4 hours post-LD~Linear mixed effects model: treatment, visit (0.5 hours to 4 hours), treatment-by-visit interaction, gender, country as fixed effects, participant as random effect~Difference in PRU = prasugrel - clopidogrel."|Mixed Models Analysis|Kenward-Roger method was used to estimate the denominator degrees of freedom for fixed effects. Invalid measurements were excluded.||||76|47|<0.0001
72569301|NCT00444457|144669740|NON_INFERIORITY_OR_EQUIVALENCE|Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|1.1|||||TWO_SIDED|95.0|-0.6|3.01||||||Common serotypes - serotype 14||3.01|-0.60|
72569302|NCT00444457|144669740|NON_INFERIORITY_OR_EQUIVALENCE|Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|0.8|||||TWO_SIDED|95.0|-1.04|2.76||||||Common serotypes - serotype 14||2.76|-1.04|
72491580|NCT00623480|144511208|SUPERIORITY_OR_OTHER||estimated diff (prohylaxis vs. OD)|13.15|||||TWO_SIDED|95.0|5.23|21.08||no p-values computed|Based on cLDA model|Adjusted for presence/absence of target joint and prior 6 month bleeding frequency||||21.08|5.23|
72491581|NCT01515787|144511222|NON_INFERIORITY|Disease recurrence or death in order to have 85% power to reject the null hypothesis. Noninferiority of the intervention could be claimed if the upper limit of the two-sided 90.2% confidence interval of the hazard ratio for disease recurrence or death did not exceed the 1.29 noninferiority margin.|Hazard Ratio (HR)|0.92||||0.005|TWO_SIDED|90.2|0.74|1.14|||kaplan meier|||||1.14|0.74|0.005
72491582|NCT01515787|144511224|SUPERIORITY||Hazard Ratio (HR)|1.04|||||TWO_SIDED|95.0|0.74|1.44||||||||1.44|0.74|
72491583|NCT01515787|144511226|SUPERIORITY||Hazard Ratio (HR)|1.18|||||TWO_SIDED|95.0|0.44|3.16||||||||3.16|0.44|
72491584|NCT03776175|144511241|SUPERIORITY||Difference in LS mean|-44.52||||0|TWO_SIDED|90.0|-54.97|-31.65|||ANCOVA||LS mean difference was not a simple subtraction between LS means of groups but through statistical model.|Natural log-transformed of individual relative change from baseline to Day 42 was analyzed using the ANCOVA model with treatment as a fixed effect, natural log-transformed baseline whole liver fat by MRI-PDFF as covariate. Values were back-transformed from the log scale. 90% CI was calculated on difference in least square (LS) mean between groups||-31.65|-54.97|0.0000
72491585|NCT03776175|144511241|SUPERIORITY||Difference in LS Mean|-35.4||||0.0007|TWO_SIDED|90.0|-47.4|-20.68|||ANCOVA||LS mean difference was not a simple subtraction between LS means of groups but through statistical model.|Natural log-transformed of individual relative change from baseline to Day 42 was analyzed using the ANCOVA model with treatment as a fixed effect, natural log-transformed baseline whole liver fat by MRI-PDFF as covariate. Values were back-transformed from the log scale. 90% CI was calculated on difference LS mean between groups.||-20.68|-47.40|0.0007
72569303|NCT00444457|144669740|NON_INFERIORITY_OR_EQUIVALENCE|Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|2.1|||||TWO_SIDED|95.0|-0.38|4.74||||||Common serotypes - serotype 18C||4.74|-0.38|
72569304|NCT00444457|144669740|NON_INFERIORITY_OR_EQUIVALENCE|Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|-0.2|||||TWO_SIDED|95.0|-2.33|1.99||||||Common serotypes - serotype 18C||1.99|-2.33|
72569305|NCT00444457|144669740|NON_INFERIORITY_OR_EQUIVALENCE|Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|-2.2|||||TWO_SIDED|95.0|-4.89|0.23||||||Common serotypes - serotype 18C||0.23|-4.89|
72569306|NCT00444457|144669740|NON_INFERIORITY_OR_EQUIVALENCE|Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|0.3|||||TWO_SIDED|95.0|-1.93|2.6||||||Common serotypes - serotype 19F||2.60|-1.93|
72405049|NCT01336738|144317499|SUPERIORITY_OR_OTHER||LS Mean Difference|-6.62|STANDARD_ERROR_OF_MEAN|5.94||0.2662|TWO_SIDED|95.0|-18.31|5.08||Two-sided p-value was calculated.|Mixed Models Analysis|||Week 8: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||5.08|-18.31|0.2662
72491586|NCT03776175|144511241|SUPERIORITY||Difference in LS Mean|-44.64||||0|TWO_SIDED|90.0|-54.8|-32.19|||ANCOVA||LS mean difference was not a simple subtraction between LS means of groups but through statistical model.|Natural log-transformed of individual relative change from baseline to Day 42 was analyzed using the ANCOVA model with treatment as a fixed effect, natural log-transformed baseline whole liver fat by MRI-PDFF as covariate. Values were back-transformed from the log scale. 90% CI was calculated on difference in LS mean between groups.||-32.19|-54.80|0.0000
72491587|NCT03776175|144511241|SUPERIORITY||Difference in LS Mean|-0.21||||0.9836|TWO_SIDED|90.0|-15.66|18.08|||ANCOVA||LS mean difference was not a simple subtraction between LS means of groups but through statistical model.|Natural log-transformed of individual relative change from baseline to Day 42 was analyzed using the ANCOVA model with treatment as a fixed effect, natural log-transformed baseline whole liver fat by MRI-PDFF as covariate. Values were back-transformed from the log scale. 90% CI was calculated on difference in LS mean between groups.||18.08|-15.66|0.9836
72491588|NCT03776175|144511241|SUPERIORITY||Difference in LS Mean|-14.3||||0.1233|TWO_SIDED|90.0|-27.32|1.06|||ANCOVA||LS mean difference was not a simple subtraction between LS means of groups but through statistical model.|Natural log-transformed of individual relative change from baseline to Day 42 was analyzed using the ANCOVA model with treatment as a fixed effect, natural log-transformed baseline whole liver fat by MRI-PDFF as covariate. Values were back-transformed from the log scale. 90% CI was calculated on difference in LS mean between groups.||1.06|-27.32|0.1233
72491589|NCT03776175|144511241|SUPERIORITY||Difference in LS Mean|-0.21|||||TWO_SIDED|50.0|-6.82|6.87|||||LS mean difference was not a simple subtraction between LS means of groups but through statistical model.|Natural log-transformed of individual relative change from baseline to Day 42 was analyzed using the ANCOVA model with treatment as a fixed effect, natural log-transformed baseline whole liver fat by MRI-PDFF as covariate. Values were back-transformed from the log scale. 50% CI was calculated on difference in LS mean between groups.||6.87|-6.82|
72491590|NCT03776175|144511241|SUPERIORITY||Difference in LS Mean|-14.3|||||TWO_SIDED|50.0|-19.86|-8.35|||||LS mean difference was not a simple subtraction between LS means of groups but through statistical model.|Natural log-transformed of individual relative change from baseline to Day 42 was analyzed using the ANCOVA model with treatment as a fixed effect, natural log-transformed baseline whole liver fat by MRI-PDFF as covariate. Values were back-transformed from the log scale. 50% CI was calculated on difference in LS mean between groups.||-8.35|-19.86|
72491591|NCT05525533|144511272|SUPERIORITY||Mean Difference (Final Values)|0.17|||||TWO_SIDED|95.0|-1.87|2.24|||Regression, Linear|||||2.24|-1.87|
72491592|NCT05525533|144511272|SUPERIORITY||Mean Difference (Final Values)|1.55|||||TWO_SIDED|95.0|-0.73|3.82|||Regression, Linear|||||3.82|-0.73|
72491593|NCT05525533|144511274|SUPERIORITY||Mean Difference (Final Values)|7.58|||||TWO_SIDED|95.0|-2.92|18.0|||Regression, Linear|||||18|-2.92|
72517418|NCT00830960|144564675|SUPERIORITY_OR_OTHER||LS Mean Difference in Percent Inhibition|48.0|||<|0.0001|TWO_SIDED|95.0|36.0|59.0||"P-value for 4 hours post-LD~Linear mixed effects model: treatment, visit (0.5 hours to 4 hours), treatment-by-visit interaction, gender, country as fixed effects, participant as random effect~Difference in PRU = prasugrel - clopidogrel."|Mixed Models Analysis|Kenward-Roger method was used to estimate the denominator degrees of freedom for fixed effects. Invalid measurements were excluded.||||59|36|<0.0001
72517419|NCT00830960|144564675|SUPERIORITY_OR_OTHER||LS Mean Difference in Percent Inhibition|56.0|||<|0.0001|TWO_SIDED|95.0|44.0|68.0||"P-value for 4 hours post-LD~Linear mixed effects model: treatment, visit (0.5 hours to 4 hours), treatment-by-visit interaction, gender, country as fixed effects, participant as random effect~Difference in PRU = prasugrel - clopidogrel."|Mixed Models Analysis|Kenward-Roger method was used to estimate the denominator degrees of freedom for fixed effects. Invalid measurements were excluded.||||68|44|<0.0001
72569307|NCT00444457|144669740|NON_INFERIORITY_OR_EQUIVALENCE|Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|-1.5|||||TWO_SIDED|95.0|-3.46|0.28||||||Common serotypes - serotype 19F||0.28|-3.46|
72491594|NCT05525533|144511274|SUPERIORITY||Mean Difference (Final Values)|16.0|||||TWO_SIDED|95.0|0.64|31.0|||Regression, Linear|||||31|0.64|
72491595|NCT05525533|144511276|SUPERIORITY||Mean Difference (Final Values)|47.0|||||TWO_SIDED|95.0|-18.0|113.0|||Regression, Linear|||||113|-18|
72569308|NCT00444457|144669740|NON_INFERIORITY_OR_EQUIVALENCE|Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|-1.8|||||TWO_SIDED|95.0|-3.87|0.02||||||Common serotypes - serotype 19F||0.02|-3.87|
72569309|NCT00444457|144669740|NON_INFERIORITY_OR_EQUIVALENCE|Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|3.2|||||TWO_SIDED|95.0|-1.03|7.46||||||Common serotypes - serotype 23F||7.46|-1.03|
72569310|NCT00444457|144669740|NON_INFERIORITY_OR_EQUIVALENCE|Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|4.0|||||TWO_SIDED|95.0|-0.27|8.39||||||Common serotypes - serotype 23F||8.39|-0.27|
72569311|NCT00444457|144669740|NON_INFERIORITY_OR_EQUIVALENCE|Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|0.8|||||TWO_SIDED|95.0|-3.75|5.46||||||Common serotypes - serotype 23F||5.46|-3.75|
72569312|NCT00444457|144669740|NON_INFERIORITY_OR_EQUIVALENCE|Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|0.8|||||TWO_SIDED|95.0|-1.48|3.18||||||Additional serotypes - serotype 1||3.18|-1.48|
72491596|NCT05525533|144511276|SUPERIORITY||Mean Difference (Final Values)|113.0|||||TWO_SIDED|95.0|38.0|189.0|||Regression, Linear|||||189|38|
72491597|NCT05525533|144511277|SUPERIORITY||Mean Difference (Final Values)|3.63|||||TWO_SIDED|95.0|-1.37|8.63|||Regression, Linear|||||8.63|-1.37|
72569313|NCT00444457|144669740|NON_INFERIORITY_OR_EQUIVALENCE|Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|-0.7|||||TWO_SIDED|95.0|-2.78|1.34||||||Additional serotypes - serotype 1||1.34|-2.78|
72405050|NCT01336738|144317499|SUPERIORITY_OR_OTHER||LS Mean Difference|-21.52|STANDARD_ERROR_OF_MEAN|5.818||0.0003|TWO_SIDED|95.0|-32.97|-10.07||Two-sided p-value was calculated.|Mixed Models Analysis|||Week 8: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||-10.07|-32.97|0.0003
72491598|NCT05525533|144511277|SUPERIORITY||Mean Difference (Final Values)|1.5|||||TWO_SIDED|95.0|-1.5|4.5|||Regression, Linear|||||4.50|-1.50|
72491599|NCT05525533|144511278|SUPERIORITY||Mean Difference (Final Values)|1.32|||||TWO_SIDED|95.0|-0.36|7.3|||Regression, Linear|||||7.30|-0.36|
72491600|NCT05525533|144511278|SUPERIORITY||Mean Difference (Final Values)|3.38|||||TWO_SIDED|95.0|-0.54|7.3|||Regression, Linear|||||7.30|-0.54|
72491601|NCT05525533|144511279|SUPERIORITY||Mean Difference (Final Values)|0.17|||||TWO_SIDED|95.0|-3.38|3.72|||Regression, Linear|||||3.72|-3.38|
72517420|NCT00830960|144564676|SUPERIORITY_OR_OTHER||LS Mean Difference in Percent Inhibition|38.0|||<|0.0001|TWO_SIDED|95.0|27.0|50.0||"P-value for 30 days post-LD~Linear mixed effects model: treatment, visit (30, 90 days during MD), treatment-by-visit interaction, gender, country as fixed effects, participant as random effect~Difference in PRU = prasugrel - clopidogrel."|Mixed Models Analysis|Kenward-Roger method was used to estimate the denominator degrees of freedom for fixed effects. Invalid measurements were excluded.||||50|27|<0.0001
72517421|NCT00830960|144564676|SUPERIORITY_OR_OTHER||LS Mean Difference in Percent Inhibition|32.0|||<|0.0001|TWO_SIDED|95.0|21.0|42.0||"P-value for 30 days post-LD~Linear mixed effects model: treatment, visit (30, 90 days during MD), treatment-by-visit interaction, gender, country as fixed effects, participant as random effect~Difference in PRU = prasugrel - clopidogrel."|Mixed Models Analysis|Kenward-Roger method was used to estimate the denominator degrees of freedom for fixed effects. Invalid measurements were excluded.||||42|21|<0.0001
72491602|NCT05525533|144511279|SUPERIORITY||Mean Difference (Final Values)|7.57|||||TWO_SIDED|95.0|0.42|15.0|||Regression, Linear|||||15|0.42|
72491603|NCT05525533|144511280|SUPERIORITY||Mean Difference (Final Values)|2.46|||||TWO_SIDED|95.0|-0.11|5.02|||Regression, Linear|||||5.02|-0.11|
72491604|NCT05525533|144511280|SUPERIORITY||Mean Difference (Final Values)|3.29|||||TWO_SIDED|95.0|0.33|6.25|||Regression, Linear|||||6.25|0.33|
72491605|NCT02429414|144511302|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
72491606|NCT02429414|144511303|SUPERIORITY|||||||0.0209|||||||t-test, 2 sided|||||||0.0209
72491607|NCT02429414|144511304|SUPERIORITY|||||||0.078|||||||t-test, 2 sided|||||||0.078
72517422|NCT00830960|144564676|SUPERIORITY_OR_OTHER||LS Mean Difference in Percent Inhibition|17.0||||0.0026|TWO_SIDED|95.0|6.0|28.0||"P-value for 30 days post-LD~Linear mixed effects model: treatment, visit (30, 90 days during MD), treatment-by-visit interaction, gender, country as fixed effects, participant as random effect~Difference in PRU = prasugrel - clopidogrel."|Mixed Models Analysis|Kenward-Roger method was used to estimate the denominator degrees of freedom for fixed effects. Invalid measurements were excluded.||||28|6|0.0026
72569314|NCT00444457|144669740|NON_INFERIORITY_OR_EQUIVALENCE|Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|-1.5|||||TWO_SIDED|95.0|-3.77|0.67||||||Additional serotypes - serotype 1||0.67|-3.77|
72491608|NCT03015259|144511330|EQUIVALENCE|To show the clinical equivalence, an analysis of covariance model was fit on the participants from the test budesonide/formoterol fumarate and Symbicort groups, with the endpoint as outcome and treatment, study site and treatment by site interaction as fixed effects and FEV1 baseline value as covariate.|Test/Referece LS Mean Ratio|1.04|||||TWO_SIDED|90.0|0.958|1.13|||||Fieller's formula was applied|Only Treatments 1 and 2 were compared for equivalence. Treatment 3 (placebo) was subtracted from both Treatments 1 and 2, as this primary endpoint was baseline adjusted.||1.130|0.958|
72491609|NCT03015259|144511331|EQUIVALENCE|To show the clinical equivalence, an ANCOVA model was fit with the endpoint as outcome and treatment, study site and treatment-by site interaction as fixed effects and FEV1 baseline value as covariate.|Test/Reference LS Mean Ratio|1.004|||||TWO_SIDED|90.0|0.889|1.14|||||Fieller's formula was applied|Treatments 1 and 2 were baseline adjusted by subtracting Treatment 3 (placebo) from each.||1.140|0.889|
72491610|NCT03015259|144511332|OTHER|||||||||||||||||Comparison of means, no formal statistical comparison|no statistical significance applied|||
72491611|NCT00143312|144511368|SUPERIORITY_OR_OTHER||Crude IFI Rate (percent) at 12 months|7.0||||||95.0|2.0|19.0||||||||19|2|
72491612|NCT00143312|144511368|SUPERIORITY_OR_OTHER||IFI Rate (percent) at 12 months|10.0||||||95.0|2.0|27.0||||||||27|2|
72491613|NCT00143312|144511369|SUPERIORITY_OR_OTHER||IFI Rate (percent) at 6 months|8.82||||||95.0|2.0|24.0|||||Exact 95% Confidence Interval For Proportion; Expressed as a percentage|||24|2|
72491614|NCT00143312|144511370|SUPERIORITY_OR_OTHER||IFI Rate (percent) at End of Prophylaxis|8.82||||||95.0|2.0|24.0|||||Exact 95% Confidence Interval For Proportion; Expressed as a percentage|||24|2|
72491615|NCT00143312|144511374|SUPERIORITY_OR_OTHER||survive free of IFI (percent): 6 months|79.0||||||95.0|64.0|91.0|||||Exact 95% Confidence Interval For Proportion; Expressed as a percentage|||91|64|
72491616|NCT00143312|144511374|SUPERIORITY_OR_OTHER||survive free of IFI (percent): 12 months|69.0||||||95.0|52.0|83.0|||||Exact 95% Confidence Interval For Proportion; Expressed as a percentage|||83|52|
72491617|NCT03341962|144511382|SUPERIORITY||Odds Ratio (OR)|1.0188||||0.5836|TWO_SIDED||||||Cochran-Mantel-Haenszel|1-sided exact test adjusted for stratification factors (prior use of any biologics and concurrent use of corticosteroids), α=0.097||||||0.5836
72491618|NCT00513500|144511438|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|5.32||||||95.0|2.19|8.94||||||||8.94|2.19|
72491619|NCT00513500|144511439|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.23||||||95.0|0.14|0.38||||||||0.38|0.14|
72491620|NCT00513500|144511440|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.44||||||95.0|0.21|0.93||||||||0.93|0.21|
72405051|NCT01336738|144317499|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.01|STANDARD_ERROR_OF_MEAN|6.94||0.7724|TWO_SIDED|95.0|-15.68|11.66||Two-sided p-value was calculated.|Mixed Models Analysis|||Week 12: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||11.66|-15.68|0.7724
72405052|NCT01336738|144317499|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|6.986||0.9202|TWO_SIDED|95.0|-14.47|13.07||Two-sided p-value was calculated.|Mixed Models Analysis|||Week 12: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||13.07|-14.47|0.9202
72405053|NCT01336738|144317499|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.61|STANDARD_ERROR_OF_MEAN|6.998||0.8183|TWO_SIDED|95.0|-15.4|12.18||Two-sided p-value was calculated.|Mixed Models Analysis|||Week 12: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||12.18|-15.40|0.8183
72405054|NCT01336738|144317499|SUPERIORITY_OR_OTHER||LS Mean Difference|-24.96|STANDARD_ERROR_OF_MEAN|6.821||0.0003|TWO_SIDED|95.0|-38.4|-11.53||Two-sided p-value was calculated.|Mixed Models Analysis|||Week 12: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||-11.53|-38.40|0.0003
72569315|NCT00444457|144669740|NON_INFERIORITY_OR_EQUIVALENCE|Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|-3.9|||||TWO_SIDED|95.0|-10.27|2.45||||||Additional serotypes - serotype 3||2.45|-10.27|
72569316|NCT00444457|144669740|NON_INFERIORITY_OR_EQUIVALENCE|Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|-10.7|||||TWO_SIDED|95.0|-16.8|-4.57||||||Additional serotypes - serotype 3||-4.57|-16.80|
72569317|NCT00444457|144669740|NON_INFERIORITY_OR_EQUIVALENCE|Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|-6.8|||||TWO_SIDED|95.0|-12.76|-0.74||||||Additional serotypes - serotype 3||-0.74|-12.76|
72491621|NCT00749996|144511445|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.61||||0.228|TWO_SIDED|95.0|-1.59|0.38|||t-test, 2 sided|||The null-hypothesis: Ho: Δ VAS DIAM = Δ VAS Control will be tested against the alternative hypothesis:HA: Δ VAS DIAM ≠ Δ VAS Control.Where Δ is the average decrease in VAS score (baseline - 6 months). A minimal sample size of 240 analyzable patients is required to demonstrate with 80% power a difference in back pain reduction that is significant at the 95% level, comparing DIAM and Control groups. 268 patients will be enroll to allow of up to 10% attrition.||0.38|-1.59|0.228
72491622|NCT00749996|144511446|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.36||||0.719|TWO_SIDED|95.0|-8.8|6.08|||t-test, 2 sided|||The null-hypothesis(Ho: Δ ODI DIAM = Δ ODI Control) will be tested against the alternative hypothesis (HA: Δ ODI DIAM ≠ Δ ODI Control). Δ ODI DIAM = average change in the ODI (12 months - baseline) in the DIAM treated patient group and Δ VAS Control =average change in the ODI in the Control group.||6.08|-8.80|0.719
72491623|NCT00606086|144511452|SUPERIORITY_OR_OTHER|||||||1|||||||Cochran-Mantel-Haenszel test|||||||1.000
72491624|NCT02500628|144511453|OTHER|||||||0.77|||||||t-test, 2 sided|||comparison between fibromyalgia and non-fibromyalgia group||||0.77
72491625|NCT02500628|144511454|OTHER|||||||0.27|||||||t-test, 2 sided|||||||0.27
72569318|NCT00444457|144669740|NON_INFERIORITY_OR_EQUIVALENCE|Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|3.9|||||TWO_SIDED|95.0|0.15|7.69||||||Additional serotypes - serotype 5||7.69|0.15|
72569319|NCT00444457|144669740|NON_INFERIORITY_OR_EQUIVALENCE|Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|-0.2|||||TWO_SIDED|95.0|-3.52|3.09||||||Additional serotypes - serotype 5||3.09|-3.52|
72405055|NCT01336738|144317500|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.048||0.2327|TWO_SIDED|80.0|-0.1|0.03||One-sided p-value was calculated.|Mixed Models Analysis|||Week 1: Treatment difference and 80% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction as the covariates, time was repeated for participant.||0.03|-0.10|0.2327
72491626|NCT02500628|144511455|OTHER|||||||0.92|||||||t-test, 2 sided|||difference between fibromyalgia and non-fibromyalgia patients.||||0.92
72491627|NCT02692495|144511459|OTHER||||||<|0.01|||||||t-test, 2 sided|||||||<0.01
72491628|NCT01627860|144511464|SUPERIORITY_OR_OTHER||Difference in Seizure free rate|23.57||||0.0759|TWO_SIDED|95.0|-4.21|49.0|||ANOVA||Difference in Seizure free rate (Monotherapy minus Add on therapy)|||49.00|-4.21|0.0759
72491629|NCT01627860|144511465|SUPERIORITY_OR_OTHER||Difference in mean percent change|18.3||||0.7102|TWO_SIDED|95.0|-81.0|117.7|||ANCOVA||Difference in mean percent change of seizure frequency (Monotherapy minus Add on therapy)|||117.7|-81.0|0.7102
72491630|NCT02249143|144511468|SUPERIORITY||Mean Difference (Net)|6.62|||<|0.05|TWO_SIDED|95.0|0.02|13.22|||Regression, Linear|||FRC values over time were modeled using linear mixed effects regression with treatment group vs. time interaction and repeated measures for the randomization, 2 week, and discharge time points. Compound symmetric covariance structures were used to account for the correlation of FRC values within each patient. We compared outcomes between the two treatment groups and included adjustments for gender, twin gestation, and weight at randomization.||13.22|0.02|<0.05
72491631|NCT02249143|144511469|SUPERIORITY||||||>|0.05|||||||t-test, 2 sided|||||||>0.05
72491632|NCT02249143|144511469|SUPERIORITY|||||||||||||||||Group differences in the secondary outcomes were tested at randomization, two weeks, and discharge using independent samples t-tests.||||
72491633|NCT01783080|144511481|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.4||||0.005|TWO_SIDED||||||Regression, Linear|||||||0.005
72491634|NCT01783080|144511483|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.26||||0.11|TWO_SIDED||||||Regression, Linear|||||||0.11
72491635|NCT02533063|144511487|SUPERIORITY|||||||0.217|||||||ANOVA|||||||0.217
72491636|NCT02533063|144511488|SUPERIORITY|||||||0.501|||||||ANOVA|||||||0.501
72491637|NCT02533063|144511489|SUPERIORITY|||||||0.151|||||||ANOVA|||||||0.151
72491638|NCT02533063|144511490|SUPERIORITY|||||||0.45|||||||ANOVA|||||||0.450
72491639|NCT02533063|144511491|SUPERIORITY|||||||0.678|||||||ANOVA|||||||0.678
72491640|NCT02533063|144511492|SUPERIORITY|||||||0.06|||||||ANOVA|||||||0.060
72491641|NCT02533063|144511495|SUPERIORITY|||||||0.483|||||||ANOVA|||||||0.483
72624777|NCT01346592|144778966|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (B strain)|2.92|||||TWO_SIDED|95.0|2.57|3.31||||||No risk subjects.||3.31|2.57|
72491642|NCT00159861|144511510|SUPERIORITY_OR_OTHER_LEGACY||Kaplan-Meier estimate|0.095|||||TWO_SIDED|95.0|0.059|0.132||||||1 Year: Proportion of participants who died.||0.132|0.059|
72491643|NCT00159861|144511510|SUPERIORITY_OR_OTHER_LEGACY||Kaplan-Meier estimate|0.194|||||TWO_SIDED|95.0|0.144|0.243||||||2 Years: Proportion of participants who died.||0.243|0.144|
72491644|NCT00159861|144511510|SUPERIORITY_OR_OTHER_LEGACY||Kaplan-Meier estimate|0.26|||||TWO_SIDED|95.0|0.205|0.315||||||3 Years: Proportion of participants who died.||0.315|0.205|
72491645|NCT00159861|144511510|SUPERIORITY_OR_OTHER_LEGACY||Kaplan-Meier estimate|0.291|||||TWO_SIDED|95.0|0.234|0.348||||||4 Years: Proportion of participants who died.||0.348|0.234|
72491646|NCT00159861|144511510|SUPERIORITY_OR_OTHER_LEGACY||Kaplan-Meier estimate|0.369|||||TWO_SIDED|95.0|0.302|0.437||||||5 Years: Proportion of participants who died.||0.437|0.302|
72491647|NCT01500759|144511570|OTHER||Odds Ratio (OR)|1.9|||||TWO_SIDED|95.0||||||||||||
72491648|NCT01500759|144511571|OTHER||Odds Ratio (OR)|1.19|||||TWO_SIDED|95.0||||||||||||
72624778|NCT01346592|144778966|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (H1N1 strain)|1.53|||||TWO_SIDED|95.0|0.6|3.93||||||At risk subjects.||3.93|0.6|
72491649|NCT01500759|144511572|OTHER||Odds Ratio (OR)|0.92|||||TWO_SIDED|||||||||||||
72491650|NCT01500759|144511573|OTHER||Odds Ratio (OR)|1.12|||||TWO_SIDED|95.0||||||||||||
72491651|NCT01290874|144511576|SUPERIORITY|||||||0.31|||||||Log Rank|||||||0.31
72491652|NCT01137773|144511648|SUPERIORITY|||||||0.49|||||||t-test, 2 sided|||||||0.49
72491653|NCT01137773|144511649|SUPERIORITY|||||||0.7|||||||t-test, 2 sided|||||||.70
72491654|NCT04749459|144511662|OTHER|A minimum of 10 valid results was defined as the number required to produce mean study product (or control standard) SPF with 95% confidence interval (CI) within +/- 17% of the measured mean SPF of the study product (or control standard).|||||||||||||||||CSM Classic: CIs +/- 13.7% P2 Control Standard (vs. CSM Classic) CIs +/- 16.4%|||
72491655|NCT04749459|144511662|OTHER|A minimum of 10 valid results was defined as the number required to produce mean study product (or control standard) SPF with 95% confidence interval (CI) within +/- 17% of the measured mean SPF of the study product (or control standard).|||||||||||||||||CSM Strawberry Flavor: CIs +/- 16.6% P2 Control Standard (vs CSM Strawberry Flavour): CIs +/- 16.0%|||
72491656|NCT00983983|144511680|SUPERIORITY_OR_OTHER|||||||0.07|TWO_SIDED||||||Mixed Models Analysis|||Change over time in the ALSFRS-R was analyzed using random-slopes models||||0.07
72491657|NCT00983983|144511682|SUPERIORITY_OR_OTHER|||||||0.06|TWO_SIDED||||||Fisher Exact|||||||0.06
72491658|NCT00983983|144511683|SUPERIORITY_OR_OTHER|||||||0.0005|TWO_SIDED||||||Fisher Exact|||||||0.0005
72491659|NCT00983983|144511684|SUPERIORITY_OR_OTHER|||||||0.03|TWO_SIDED||||||Fisher Exact|||||||0.03
72491660|NCT02970292|144511710|SUPERIORITY||Difference in MMRM LSMs|-2.1|STANDARD_ERROR_OF_MEAN|1.24||0.094|TWO_SIDED|95.0|-4.5|0.4|||mixed-effects model for repeated measure|||||0.4|-4.5|0.0940
72491661|NCT04770389|144511731|SUPERIORITY||Least Squares (LS) Mean|-44.92|STANDARD_ERROR_OF_MEAN|5.183|<|0.0001|TWO_SIDED|95.0|-55.2|-34.63|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-34.63|-55.20|<0.0001
72491662|NCT04770389|144511732|SUPERIORITY||Least Squares (LS) Mean|-44.92|STANDARD_ERROR_OF_MEAN|5.183|<|0.0001|TWO_SIDED|95.0|-55.2|-34.63|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-34.63|-55.20|<0.0001
72491663|NCT04770389|144511733|SUPERIORITY||Least Squares (LS) Mean|-44.92|STANDARD_ERROR_OF_MEAN|5.183|<|0.0001|TWO_SIDED|95.0|-55.2|-34.63|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-34.63|-55.20|<0.0001
72491664|NCT04770389|144511734|SUPERIORITY||Least Squares (LS) Mean|-43.33|STANDARD_ERROR_OF_MEAN|5.517|<|0.0001|TWO_SIDED|95.0|-54.29|-32.36|||ANCOVA|||||-32.36|-54.29|<0.0001
72491665|NCT04770389|144511735|SUPERIORITY||Least Squares (LS) Mean|-43.33|STANDARD_ERROR_OF_MEAN|5.517|<|0.0001|TWO_SIDED|95.0|-54.29|-32.36|||ANCOVA|||||-32.36|-54.29|<0.0001
72491666|NCT04770389|144511736|SUPERIORITY||Least Squares (LS) Mean|-43.33|STANDARD_ERROR_OF_MEAN|5.517|<|0.0001|TWO_SIDED|95.0|-54.29|-32.36|||ANCOVA|||||-32.36|-54.29|<0.0001
72491667|NCT04770389|144511737|SUPERIORITY||Least Squares (LS) Means|-33.36|STANDARD_ERROR_OF_MEAN|5.176|<|0.0001|TWO_SIDED|95.0|-43.63|-23.09|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-23.09|-43.63|<0.0001
72491668|NCT04770389|144511738|SUPERIORITY||Least Squares (LS) Mean|-33.36|STANDARD_ERROR_OF_MEAN|5.176|<|0.0001|TWO_SIDED|95.0|-43.63|-23.09|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-23.09|-43.63|<0.0001
72491669|NCT04770389|144511739|SUPERIORITY||Least Squares (LS) Mean|-33.36|STANDARD_ERROR_OF_MEAN|5.176|<|0.0001|TWO_SIDED|95.0|-43.63|-23.09|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-23.09|-43.63|<0.0001
72491670|NCT04770389|144511740|SUPERIORITY||Least Squares (LS) Mean|-28.2|STANDARD_ERROR_OF_MEAN|5.596|<|0.0001|TWO_SIDED|95.0|-39.32|-17.08|||ANCOVA|||||-17.08|-39.32|<0.0001
72491671|NCT04770389|144511741|SUPERIORITY||Least Squares (LS) Mean|-28.2|STANDARD_ERROR_OF_MEAN|5.596|<|0.0001|TWO_SIDED|95.0|-39.32|-17.08|||ANCOVA|||||-17.08|-39.32|<0.0001
72491672|NCT04770389|144511742|SUPERIORITY||Least Squares (LS) Mean|-28.2|STANDARD_ERROR_OF_MEAN|5.596|<|0.0001|TWO_SIDED|95.0|-39.32|-17.08|||ANCOVA|||||-17.08|-39.32|<0.0001
72491673|NCT04770389|144511743|SUPERIORITY||Least Squares (LS) Means|-29.62|STANDARD_ERROR_OF_MEAN|3.78|<|0.0001|TWO_SIDED|95.0|-37.12|-22.12|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-22.12|-37.12|<0.0001
72491674|NCT04770389|144511744|SUPERIORITY||Least Squares (LS) Mean|-29.62|STANDARD_ERROR_OF_MEAN|3.78|<|0.0001|TWO_SIDED|95.0|-37.12|-22.12|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-22.12|-37.12|<0.0001
72491675|NCT04770389|144511745|SUPERIORITY||Least Squares (LS) Means|-29.62|STANDARD_ERROR_OF_MEAN|3.78|<|0.0001|TWO_SIDED|95.0|-37.12|-22.12|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-22.12|-37.12|<0.0001
72491676|NCT04770389|144511746|SUPERIORITY||Least Squares (LS) Mean|-22.36|STANDARD_ERROR_OF_MEAN|3.768|<|0.0001|TWO_SIDED|95.0|-29.83|-14.88|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-14.88|-29.83|<0.0001
72491677|NCT04770389|144511747|SUPERIORITY||Least Squares (LS) Mean|-22.36|STANDARD_ERROR_OF_MEAN|3.768|<|0.0001|TWO_SIDED|95.0|-29.83|-14.88|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-14.88|-29.83|<0.0001
72491678|NCT04770389|144511748|SUPERIORITY||Least Squares (LS) Mean|-22.36|STANDARD_ERROR_OF_MEAN|3.768|<|0.0001|TWO_SIDED|95.0|-29.83|-14.88|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-14.88|-29.83|<0.0001
72491679|NCT04770389|144511749|SUPERIORITY||Least Squares (LS) Means|-30.13|STANDARD_ERROR_OF_MEAN|5.254|<|0.0001|TWO_SIDED|95.0|-40.55|-19.71|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-19.71|-40.55|<0.0001
72491680|NCT04770389|144511750|SUPERIORITY||Least Squares (LS) Mean|-30.13|STANDARD_ERROR_OF_MEAN|5.254|<|0.0001|TWO_SIDED|95.0|-40.55|-19.71|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-19.71|-40.55|<0.0001
72491681|NCT04770389|144511751|SUPERIORITY||Least Squares (LS) Mean|-30.13|STANDARD_ERROR_OF_MEAN|5.254|<|0.0001|TWO_SIDED|95.0|-40.55|-19.71|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-19.71|-40.55|<0.0001
72491682|NCT04770389|144511752|SUPERIORITY||Least Squares (LS) Means|-18.58|STANDARD_ERROR_OF_MEAN|5.196||0.0005|TWO_SIDED|95.0|-28.88|-8.27|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-8.27|-28.88|0.0005
72491683|NCT04770389|144511753|SUPERIORITY||Least Squares (LS) Mean|-18.58|STANDARD_ERROR_OF_MEAN|5.196||0.0005|TWO_SIDED|95.0|-28.88|-8.27|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-8.27|-28.88|0.0005
72491684|NCT04770389|144511754|SUPERIORITY||Least Squares (LS) Mean|-18.58|STANDARD_ERROR_OF_MEAN|5.196||0.0005|TWO_SIDED|95.0|-28.88|-8.27|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-8.27|-28.88|0.0005
72491685|NCT04770389|144511755|SUPERIORITY||Least Squares (LS) Means|-14.79|STANDARD_ERROR_OF_MEAN|5.165||0.0051|TWO_SIDED|95.0|-25.03|-4.54|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-4.54|-25.03|0.0051
72491686|NCT04770389|144511756|SUPERIORITY||Least Squares (LS) Mean|-14.79|STANDARD_ERROR_OF_MEAN|5.165||0.0051|TWO_SIDED|95.0|-25.03|-4.54|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-4.54|-25.03|0.0051
72491687|NCT04770389|144511757|SUPERIORITY||Least Squares (LS) Mean|-14.79|STANDARD_ERROR_OF_MEAN|5.165||0.0051|TWO_SIDED|95.0|-25.03|-4.54|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-4.54|-25.03|0.0051
72491688|NCT04770389|144511758|SUPERIORITY||Least Squares (LS) Mean|-12.77|STANDARD_ERROR_OF_MEAN|5.58||0.0245|TWO_SIDED|95.0|-23.86|-1.68|||ANCOVA|||||-1.68|-23.86|0.0245
72491689|NCT04770389|144511759|SUPERIORITY||Least Squares (LS) Mean|-12.77|STANDARD_ERROR_OF_MEAN|5.58||0.0245|TWO_SIDED|95.0|-23.86|-1.68|||ANCOVA|||||-1.68|-23.86|0.0245
72491690|NCT04770389|144511760|SUPERIORITY||Least Squares (LS) Mean|-12.77|STANDARD_ERROR_OF_MEAN|5.58||0.0245|TWO_SIDED|95.0|-23.86|-1.68|||ANCOVA|||||-1.68|-23.86|0.0245
72491691|NCT04770389|144511761|SUPERIORITY||Least Squares (LS) Mean|-20.81|STANDARD_ERROR_OF_MEAN|3.822|<|0.0001|TWO_SIDED|95.0|-28.39|-13.22|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-13.22|-28.39|<0.0001
72491692|NCT04770389|144511762|SUPERIORITY||Least Squares (LS) Mean|-20.81|STANDARD_ERROR_OF_MEAN|3.822|<|0.0001|TWO_SIDED|95.0|-28.39|-13.22|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-13.22|-28.39|<0.0001
72491693|NCT04770389|144511763|SUPERIORITY||Least Squares (LS) Mean|-20.81|STANDARD_ERROR_OF_MEAN|3.822|<|0.0001|TWO_SIDED|95.0|-28.39|-13.22|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-13.22|-28.39|<0.0001
72569320|NCT00444457|144669740|NON_INFERIORITY_OR_EQUIVALENCE|Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|-4.1|||||TWO_SIDED|95.0|-7.92|-0.36||||||Additional serotypes - serotype 5||-0.36|-7.92|
72569321|NCT00444457|144669740|NON_INFERIORITY_OR_EQUIVALENCE|Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|2.5|||||TWO_SIDED|95.0|0.12|5.23||||||Additional serotypes - serotype 6A||5.23|0.12|
72569322|NCT00444457|144669740|NON_INFERIORITY_OR_EQUIVALENCE|Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|-0.2|||||TWO_SIDED|95.0|-2.22|1.86||||||Additional serotypes - serotype 6A||1.86|-2.22|
72569323|NCT00444457|144669740|NON_INFERIORITY_OR_EQUIVALENCE|Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|-2.7|||||TWO_SIDED|95.0|-5.39|-0.27||||||Additional serotypes - serotype 6A||-0.27|-5.39|
72624779|NCT01346592|144778966|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (H3N2 strain)|2.02|||||TWO_SIDED|95.0|0.89|4.61||||||At risk subjects.||4.61|0.89|
72405056|NCT01336738|144317500|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.048||0.358|TWO_SIDED|80.0|-0.08|0.04||One-sided p-value was calculated.|Mixed Models Analysis|||Week 1: Treatment difference and 80% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction as the covariates, time was repeated for participant.||0.04|-0.08|0.3580
72405057|NCT01336738|144317500|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.049||0.0036|TWO_SIDED|80.0|-0.2|-0.07||One-sided p-value was calculated.|Mixed Models Analysis|||Week 1: Treatment difference and 80% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction as the covariates, time was repeated for participant.||-0.07|-0.20|0.0036
72491694|NCT00708123|144511805|SUPERIORITY_OR_OTHER||Adjusted mean difference|3.97||||0.0265|TWO_SIDED|95.0|0.47|7.48||No adjustment was made for multiple comparisons as primary comparisons were pre-defined.|ANOVA|The analysis included factors treatment, period and subject as a random effect.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments being compared. Tests were 2-sided at 5% significance level.||7.48|0.47|0.0265
72491695|NCT00708123|144511805|SUPERIORITY_OR_OTHER||Adjusted mean difference|5.66||||0.0017|TWO_SIDED|95.0|2.15|9.18||No adjustment was made for multiple comparisons as primary comparisons were pre-defined.|ANOVA|The analysis included factors as treatment, period and subject as a random effect.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments being compared. Tests were 2-sided at 5% significance level.||9.18|2.15|0.0017
72491696|NCT00708123|144511806|SUPERIORITY_OR_OTHER||Adjusted Mean DIfference|-1.69||||0.3413|TWO_SIDED|95.0|-5.19|1.8||No adjustment was made for multiple comparisons as the primary comparisons were pre-defined.|ANOVA|ANOVA with factors for treatment, study period, and subject as random effect|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments being compared. Tests were 2-sided at 5% significance level.||1.80|-5.19|0.3413
72491697|NCT00708123|144511806|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|10.26|||<|0.0001|TWO_SIDED|95.0|6.76|13.76||No adjustments made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment, study period, and subject as random effect.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments being compared. Tests were 2-sided at 5% significance level.||13.76|6.76|<0.0001
72491698|NCT00708123|144511806|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|13.19|||<|0.0001|TWO_SIDED|95.0|9.69|16.68||No adjustment was made for multiple comparisons as the primary comparisons were pre-defined.|ANOVA|ANOVA with factors for treatment, study period, and subject as random effect|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments being compared. Tests were 2-sided at 5% significance level.||16.68|9.69|<0.0001
72491699|NCT00708123|144511806|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|8.57|||<|0.0001|TWO_SIDED|95.0|5.09|12.05||No adjustment was made for multiple comparisons as the primary comparisons were pre-defined.|ANOVA|ANOVA with factors for treatment, study period, and subject as random effect|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments being compared. Tests were 2-sided at 5% significance level.||12.05|5.09|<0.0001
72491700|NCT00708123|144511806|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|11.5|||<|0.0001|TWO_SIDED|95.0|8.01|14.98||No adjustment was made for multiple comparisons as the primary comparisons were pre-defined.|ANOVA|ANOVA with factors for treatment, study period, and subject (random effect).|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments being compared. Tests were 2-sided at 5% significance level.||14.98|8.01|<0.0001
72491701|NCT00708123|144511806|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-4.59||||0.0104|TWO_SIDED|95.0|-8.1|-1.09||No adjustment was made for multiple comparisons as the primary comparisons were pre-defined.|ANOVA|ANOVA with factors for treatment, study period, and subject as random effect|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments being compared. Tests were 2-sided at 5% significance level.||-1.09|-8.10|0.0104
72491702|NCT00708123|144511806|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|7.52|||<|0.0001|TWO_SIDED|95.0|4.04|11.01||No adjustment was made for multiple comparisons as the primary comparisons were pre-defined.|ANOVA|ANOVA with factors for treatment, study period, and subject as random effect|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments being compared. Tests were 2-sided at 5% significance level.||11.01|4.04|<0.0001
72491703|NCT00708123|144511806|SUPERIORITY_OR_OTHER||Adjusted Mean DIfference|2.93||||0.0986|TWO_SIDED|95.0|-0.55|6.41||No adjustment was made for multiple comparisons as the primary comparisons were pre-defined.|ANOVA|ANOVA with factors for treatment, study period, and subject as random effect.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments being compared. Tests were 2-sided at 5% significance level.||6.41|-0.55|0.0986
72405058|NCT01336738|144317500|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.049||0.1251|TWO_SIDED|80.0|-0.12|0.01||One-sided p-value was calculated.|Mixed Models Analysis|||Week 1: Treatment difference and 80% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction as the covariates, time was repeated for participant.||0.01|-0.12|0.1251
72405059|NCT01336738|144317500|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.066||0.3466|TWO_SIDED|80.0|-0.11|0.06||One-sided p-value was calculated.|Mixed Models Analysis|||Week 2: Treatment difference and 80% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction as the covariates, time was repeated for participant.||0.06|-0.11|0.3466
72569324|NCT00444457|144669740|NON_INFERIORITY_OR_EQUIVALENCE|Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|0.8|||||TWO_SIDED|95.0|-0.47|2.3||||||Additional serotypes - serotype 7F||2.30|-0.47|
72569325|NCT00444457|144669740|NON_INFERIORITY_OR_EQUIVALENCE|Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|0.0|||||TWO_SIDED|95.0|-1.12|1.18||||||Additional serotypes - serotype 7F||1.18|-1.12|
72569326|NCT00444457|144669740|NON_INFERIORITY_OR_EQUIVALENCE|Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|-0.7|||||TWO_SIDED|95.0|-2.3|0.52||||||Additional serotypes - serotype 7F||0.52|-2.30|
72569327|NCT00444457|144669740|NON_INFERIORITY_OR_EQUIVALENCE|Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|-1.0|||||TWO_SIDED|95.0|-2.91|0.8||||||Additional serotypes - serotype 19A||0.80|-2.91|
72405060|NCT01336738|144317500|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.066||0.0439|TWO_SIDED|80.0|-0.2|-0.03||One-sided p-value was calculated.|Mixed Models Analysis|||Week 2: Treatment difference and 80% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction as the covariates, time was repeated for participant.||-0.03|-0.20|0.0439
72517423|NCT00830960|144564676|SUPERIORITY_OR_OTHER||LS Mean Difference in Percent Inhibition|37.0|||<|0.0001|TWO_SIDED|95.0|24.0|50.0||"P-value for 30 days post-LD~Linear mixed effects model: treatment, visit (30, 90 days during MD), treatment-by-visit interaction, gender, country as fixed effects, participant as random effect~Difference in PRU = prasugrel - clopidogrel."|Mixed Models Analysis|Kenward-Roger method was used to estimate the denominator degrees of freedom for fixed effects. Invalid measurements were excluded.||||50|24|<0.0001
72517424|NCT00830960|144564676|SUPERIORITY_OR_OTHER||LS Mean Difference in Percent Inhibition|35.0||||0.0001|TWO_SIDED|95.0|18.0|52.0||"P-value for 90 days post-LD~Linear mixed effects model: treatment, visit (30, 90 days during MD), treatment-by-visit interaction, gender, country as fixed effects, participant as random effect~Difference in PRU = prasugrel - clopidogrel."|Mixed Models Analysis|Kenward-Roger method was used to estimate the denominator degrees of freedom for fixed effects. Invalid measurements were excluded.||||52|18|0.0001
72517425|NCT00830960|144564676|SUPERIORITY_OR_OTHER||LS Mean Difference in Percent Inhibition|28.0||||0.0005|TWO_SIDED|95.0|13.0|44.0||"P-value for 90 days post-LD~Linear mixed effects model: treatment, visit (30, 90 days during MD), treatment-by-visit interaction, gender, country as fixed effects, participant as random effect~Difference in PRU = prasugrel - clopidogrel."|Mixed Models Analysis|Kenward-Roger method was used to estimate the denominator degrees of freedom for fixed effects. Invalid measurements were excluded.||||44|13|0.0005
72517426|NCT00830960|144564676|SUPERIORITY_OR_OTHER||LS Mean Difference in Percent Inhibition|11.0||||0.1898|TWO_SIDED|95.0|-5.0|27.0||"P-value for 90 days post-LD~Linear mixed effects model: treatment, visit (30, 90 days during MD), treatment-by-visit interaction, gender, country as fixed effects, participant as random effect~Difference in PRU = prasugrel - clopidogrel."|Mixed Models Analysis|Kenward-Roger method was used to estimate the denominator degrees of freedom for fixed effects. Invalid measurements were excluded.||||27|-5|0.1898
72517427|NCT00830960|144564676|SUPERIORITY_OR_OTHER||LS Mean Difference in Percent Inhibition|32.0|||<|0.0001|TWO_SIDED|95.0|18.0|45.0||"P-value for 90 days post-LD~Linear mixed effects model: treatment, visit (30, 90 days during MD), treatment-by-visit interaction, gender, country as fixed effects, participant as random effect~Difference in PRU = prasugrel - clopidogrel."|Mixed Models Analysis|Kenward-Roger method was used to estimate the denominator degrees of freedom for fixed effects. Invalid measurements were excluded.||||45|18|<0.0001
72517428|NCT00830960|144564678|SUPERIORITY_OR_OTHER||LS mean difference in PRU|-110.0|||<|0.0001|TWO_SIDED|95.0|-143.0|-76.0||"Linear mixed effects model: treatment, visit, treatment-by-visit interaction, gender, country as fixed effects, baseline PRU as covariate, participant as random effect was used.~Difference in PRU = prasugrel - clopidogrel."|Mixed Models Analysis|Kenward-Roger method was used to estimate the denominator degrees of freedom for fixed effects. Invalid measurements were excluded.||||-76|-143|<0.0001
72517429|NCT00830960|144564678|SUPERIORITY_OR_OTHER||LS mean difference in PRU|-92.0|||<|0.0001|TWO_SIDED|95.0|-123.0|-60.0||"Linear mixed effects model: treatment, visit, treatment-by-visit interaction, gender, country as fixed effects, baseline PRU as covariate, participant as random effect was used.~Difference in PRU = prasugrel - clopidogrel."|Mixed Models Analysis|Kenward-Roger method was used to estimate the denominator degrees of freedom for fixed effects. Invalid measurements were excluded.||||-60|-123|<0.0001
72517430|NCT00830960|144564678|SUPERIORITY_OR_OTHER||LS mean difference in PRU|-51.0||||0.002|TWO_SIDED|95.0|-83.0|-19.0||"Linear mixed effects model: treatment, visit, treatment-by-visit interaction, gender, country as fixed effects, baseline PRU as covariate, participant as random effect was used.~Difference in PRU = prasugrel - clopidogrel."|Mixed Models Analysis|Kenward-Roger method was used to estimate the denominator degrees of freedom for fixed effects. Invalid measurements were excluded.||||-19|-83|0.0020
72517431|NCT00830960|144564685|SUPERIORITY_OR_OTHER|||||||0.255||95.0|||||Fisher Exact|||||||0.255
72517432|NCT00830960|144564685|SUPERIORITY_OR_OTHER|||||||0.427||95.0|||||Fisher Exact|||||||0.427
72517433|NCT00830960|144564685|SUPERIORITY_OR_OTHER|||||||0.683||95.0|||||Fisher Exact|||||||0.683
72517434|NCT00830960|144564685|SUPERIORITY_OR_OTHER|||||||0.034||95.0|||||Fisher Exact|||||||0.034
72517435|NCT02855450|144564692|SUPERIORITY||Least square means difference|4.7||||0.04|TWO_SIDED|95.0|0.2|9.2|||ANCOVA|Analysis results are obtained from an ANCOVA with treatment as factor and baseline value as covariate.||These statistics refer to Day 7 and primary eye||9.2|0.2|0.040
72517436|NCT02855450|144564692|SUPERIORITY||least square mean difference|2.4||||0.457|TWO_SIDED|95.0|-4.1|9.0||Analysis results are obtained from an ANCOVA with treatment as factor and baseline value as covariate.|ANCOVA|||These statistics refer to Day 28 and primary eye||9.0|-4.1|0.457
72405061|NCT01336738|144317500|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.067||0.004|TWO_SIDED|80.0|-0.27|-0.09||One-sided p-value was calculated.|Mixed Models Analysis|||Week 2: Treatment difference and 80% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction as the covariates, time was repeated for participant.||-0.09|-0.27|0.0040
72491704|NCT00708123|144511807|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|196.74||||0.0148|TWO_SIDED|95.0|38.89|354.6||No adjustment was made for multiple comparisons as the primary comparisons were pre-defined.|ANOVA|ANOVA with factors for treatment, study period, and subject as random effect.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments. Tests were 2-sided at 5% significance level.||354.60|38.89|0.0148
72491705|NCT00708123|144511807|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|246.7||||0.0024|TWO_SIDED|95.0|88.3|405.1||No adjustment was made for multiple comparisons as the primary comparisons were pre-defined.|ANOVA|ANOVA with factors for treatment, study period, and subject as random effect|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments being compared. Tests were 2-sided at 5% significance level.||405.10|88.30|0.0024
72491706|NCT00708123|144511807|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-49.96||||0.5328|TWO_SIDED|95.0|-207.62|107.71||No adjustment was made for multiple comparisons as the primary comparisons were pre-defined.|ANOVA|ANOVA with factors for treatment, study period, and subject as random effect|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments being compared. Tests were 2-sided at 5% significance level.||107.71|-207.62|0.5328
72491707|NCT00708123|144511807|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-406.19|||<|0.0001|TWO_SIDED|95.0|-564.0|-248.37||No adjustment was made for multiple comparisons as the primary comparisons were pre-defined.|ANOVA|ANOVA with factors for treatment, study period, and subject as random effect|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments being compared. Tests were 2-sided at 5% significance level.||-248.37|-564.00|<0.0001
72491708|NCT00708123|144511807|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|602.93|||<|0.0001|TWO_SIDED|95.0|445.97|759.9||No adjustment was made for multiple comparisons as the primary comparisons were pre-defined.|ANOVA|ANOVA with factors for treatment, study period, and subject as random effect|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments being compared. Tests were 2-sided at 5% significance level.||759.90|445.97|<0.0001
72517437|NCT02855450|144564692|SUPERIORITY||least square mean difference|4.0||||0.283|TWO_SIDED|95.0|-3.5|11.5||Analysis results are obtained from an ANCOVA with treatment as factor and baseline value as covariate.|ANCOVA|||These statistics refer to Day 56 and primary eye||11.5|-3.5|0.283
72517438|NCT02855450|144564692|SUPERIORITY|Analysis results are obtained from an ANCOVA with treatment as factor and baseline value as covariate.|Least square means difference|3.5||||0.147|TWO_SIDED|95.0|-1.3|8.3|||ANCOVA|||These statistics refer to Day 7 and secondary eye||8.3|-1.3|0.147
72491709|NCT00708123|144511807|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|652.89|||<|0.0001|TWO_SIDED|95.0|495.05|810.72||No adjustment was made for multiple comparisons as the primary comparisons were pre-defined.|ANOVA|ANOVA with factors for treatment, study period, and subject as random effect|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments being compared. Tests were 2-sided at 5% significance level.||810.72|495.05|<0.0001
72491710|NCT00708123|144511807|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|847.55|||<|0.0001|TWO_SIDED|95.0|690.54|1004.55||No adjustment was made for multiple comparisons as the primary comparisons were pre-defined.|ANOVA|ANOVA with factors for treatment, study period, and subject as random effect|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments being compared. Tests were 2-sided at 5% significance level.||1004.55|690.54|<0.0001
72491711|NCT00708123|144511807|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|897.5|||<|0.0001|TWO_SIDED|95.0|739.92|1055.08||No adjustment was made for multiple comparisons as the primary comparisons were pre-defined.|ANOVA|ANOVA with factors treatment, period and subject as random effect.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments being compared. Tests were 2-sided at 5% significance level.||1055.08|739.92|<0.0001
72491712|NCT00708123|144511807|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|650.8|||<|0.0001|TWO_SIDED|95.0|493.61|808.0||No adjustment was made for multiple comparisons as the primary comparisons were pre-defined.|ANOVA|ANOVA with factors for treatment, study period, and subject as random effect|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments being compared. Tests were 2-sided at 5% significance level.||808.00|493.61|<0.0001
72491713|NCT00708123|144511807|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|244.62||||0.0024|TWO_SIDED|95.0|87.62|401.61||No adjustment was made for multiple comparisons as the primary comparisons were pre-defined.|ANOVA|ANOVA with factors for treatment, study period, and subject as random effect|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments being compared. Tests were 2-sided at 5% significance level.||401.61|87.62|0.0024
72491714|NCT00533442|144511834|SUPERIORITY|||||||0.01|||||||Log Rank|||Biopsy-Proven Acute Rejection of the Kidney (logrank test).||||0.01
72517439|NCT02855450|144564692|SUPERIORITY|Analysis results are obtained from an ANCOVA with treatment as factor and baseline value as covariate.|least square mean difference|3.0||||0.421|TWO_SIDED|95.0|-4.4|10.4|||ANCOVA|||These statistics refer to Day 28 and secondary eye||10.4|-4.4|0.421
72405062|NCT01336738|144317500|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.065||0.0009|TWO_SIDED|80.0|-0.29|-0.12||One-sided p-value was calculated.|Mixed Models Analysis|||Week 2: Treatment difference and 80% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction as the covariates, time was repeated for participant.||-0.12|-0.29|0.0009
72405063|NCT01336738|144317500|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.096||0.1405|TWO_SIDED|80.0|-0.23|0.02||One-sided p-value was calculated.|Mixed Models Analysis|||Week 4: Treatment difference and 80% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction as the covariates, time was repeated for participant.||0.02|-0.23|0.1405
72405064|NCT01336738|144317500|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.24|STANDARD_ERROR_OF_MEAN|0.097||0.0067|TWO_SIDED|80.0|-0.36|-0.12||One-sided p-value was calculated.|Mixed Models Analysis|||Week 4: Treatment difference and 80% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction as the covariates, time was repeated for participant.||-0.12|-0.36|0.0067
72405065|NCT01336738|144317500|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.37|STANDARD_ERROR_OF_MEAN|0.098||0.0001|TWO_SIDED|80.0|-0.5|-0.24||One-sided p-value was calculated.|Mixed Models Analysis|||Week 4: Treatment difference and 80% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction as the covariates, time was repeated for participant.||-0.24|-0.50|0.0001
72405066|NCT01336738|144317500|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.34|STANDARD_ERROR_OF_MEAN|0.094||0.0002|TWO_SIDED|80.0|-0.46|-0.22||One-sided p-value was calculated.|Mixed Models Analysis|||Week 4: Treatment difference and 80% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction as the covariates, time was repeated for participant.||-0.22|-0.46|0.0002
72491715|NCT00533442|144511834|SUPERIORITY|||||||0.01|||||||Log Rank|||Biopsy-Proven Acute Rejection of the Pancreas (logrank test).||||0.01
72517440|NCT02855450|144564692|SUPERIORITY|Analysis results are obtained from an ANCOVA with treatment as factor and baseline value as covariate.|least square mean difference|4.3||||0.327|TWO_SIDED|95.0|-4.4|13.0|||ANCOVA|||These statistics refer to Day 56 and secondary eye||13.0|-4.4|0.327
72517441|NCT00507416|144564698|SUPERIORITY_OR_OTHER|||||||0.458||||||The global difference among arms was based on the Wald test.|Wald test|||||||0.458
72517442|NCT02157506|144564716|SUPERIORITY||||||=|0.0059|||||||Mixed Models Analysis|Statistical significance was defined by a P-value \< 0.05. No adjustments were made for multiplicity.||||||=0.0059
72517443|NCT02157506|144564716|SUPERIORITY||||||=|0.0001|||||||Mixed Models Analysis|Statistical significance was defined by a P-value \< 0.05. No adjustments were made for multiplicity.||||||= 0.0001
72517444|NCT02157506|144564716|SUPERIORITY||||||=|0.0062|||||||Mixed Models Analysis|Statistical significance was defined by a P-value \< 0.05. No adjustments were made for multiplicity.||||||= 0.0062
72517445|NCT02157506|144564716|SUPERIORITY||||||=|0.0086|||||||Mixed Models Analysis|Statistical significance was defined by a P-value \< 0.05. No adjustments were made for multiplicity.||||||= 0.0086
72517446|NCT02157506|144564717|SUPERIORITY||||||=|0.0076|||||||Mixed Models Analysis|Statistical significance was defined by a P-value \< 0.05. No adjustments were made for multiplicity.||||||= 0.0076
72491716|NCT00533442|144511834|SUPERIORITY|||||||0.16|||||||Log Rank|||Death-Censored Kidney Graft Failure (logrank test).||||0.16
72491717|NCT00533442|144511834|SUPERIORITY|||||||0.12|||||||Log Rank|||Death-Censored Pancreas Graft Failure (logrank test).||||0.12
72491718|NCT00533442|144511834|SUPERIORITY|||||||0.96|||||||Log Rank|||Death-Uncensored (Kidney \& Pancreas) Graft Survival (logrank test).||||0.96
72517447|NCT02157506|144564717|SUPERIORITY||||||=|0.0052|||||||Mixed Models Analysis|Statistical significance was defined by a P-value \< 0.05. No adjustments were made for multiplicity.||||||= 0.0052
72517448|NCT02157506|144564717|SUPERIORITY||||||=|0.1064|||||||Mixed Models Analysis|Statistical significance was defined by a P-value \< 0.05. No adjustments were made for multiplicity.||||||= 0.1064
72517449|NCT02157506|144564717|SUPERIORITY||||||=|0.1151|||||||Mixed Models Analysis|Statistical significance was defined by a P-value \< 0.05. No adjustments were made for multiplicity.||||||= 0.1151
72517450|NCT02157506|144564718|SUPERIORITY||||||=|0.4241|||||||Mixed Models Analysis|Statistical significance was defined by a P-value \< 0.05. No adjustments were made for multiplicity.||||||= 0.4241
72517451|NCT02157506|144564718|SUPERIORITY||||||=|0.4035|||||||Mixed Models Analysis|Statistical significance was defined by a P-value \< 0.05. No adjustments were made for multiplicity.||||||= 0.4035
72517452|NCT02157506|144564718|SUPERIORITY||||||=|0.8308|||||||Mixed Models Analysis|Statistical significance was defined by a P-value \< 0.05. No adjustments were made for multiplicity.||||||= 0.8308
72517453|NCT02157506|144564718|SUPERIORITY||||||=|0.118|||||||Mixed Models Analysis|Statistical significance was defined by a P-value \< 0.05. No adjustments were made for multiplicity.||||||= 0.1180
72517454|NCT02157506|144564719|SUPERIORITY||||||=|0.0048|||||||Mixed Models Analysis|Statistical significance was defined by a P-value \< 0.05. No adjustments were made for multiplicity.||||||= 0.0048
72517455|NCT02157506|144564719|SUPERIORITY||||||=|0.0022|||||||Mixed Models Analysis|Statistical significance was defined by a P-value \< 0.05. No adjustments were made for multiplicity.||||||= 0.0022
72517456|NCT02157506|144564719|SUPERIORITY||||||=|0.0045|||||||Mixed Models Analysis|Statistical significance was defined by a P-value \< 0.05. No adjustments were made for multiplicity.||||||= 0.0045
72405067|NCT01336738|144317500|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.135||0.4887|TWO_SIDED|80.0|-0.18|0.17||One-sided p-value was calculated.|Mixed Models Analysis|||Week 8: Treatment difference and 80% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction as the covariates, time was repeated for participant.||0.17|-0.18|0.4887
72491719|NCT00533442|144511834|SUPERIORITY||||||>|0.99||||||Patient Death (logrank test).|Log Rank|||||||>0.99
72491720|NCT00533442|144511835|SUPERIORITY|||||||0.21|||||||t-test, 2 sided|||Comparison of Mean eGFR at 12 Months Post-Transplant (t-test).||||0.21
72491721|NCT00533442|144511835|SUPERIORITY|||||||0.71|||||||t-test, 2 sided|||Comparison of Mean eGFR at 36 Months Post-Transplant (t-test).||||0.71
72491722|NCT00533442|144511835|SUPERIORITY|||||||0.33|||||||t-test, 2 sided|||Comparison of Mean eGFR at 60 Months Post-Transplant (t-test).||||0.33
72517457|NCT02157506|144564719|SUPERIORITY||||||=|0.0294|||||||Mixed Models Analysis|Statistical significance was defined by a P-value \< 0.05. No adjustments were made for multiplicity.||||||= 0.0294
72517458|NCT02157506|144564720|SUPERIORITY||||||=|0.2022|||||||Mixed Models Analysis|Statistical significance was defined by a P-value \< 0.05. No adjustments were made for multiplicity.||||||= 0.2022
72517459|NCT02157506|144564720|SUPERIORITY||||||=|0.0658|||||||Mixed Models Analysis|Statistical significance was defined by a P-value \< 0.05. No adjustments were made for multiplicity.||||||= 0.0658
72517460|NCT02157506|144564720|SUPERIORITY||||||=|0.0741|||||||Mixed Models Analysis|Statistical significance was defined by a P-value \< 0.05. No adjustments were made for multiplicity.||||||= 0.0741
72517461|NCT02157506|144564720|SUPERIORITY||||||=|0.0497|||||||Mixed Models Analysis|Statistical significance was defined by a P-value \< 0.05. No adjustments were made for multiplicity.||||||= 0.0497
72517462|NCT02157506|144564721|SUPERIORITY||||||=|0.1842|||||||Mixed Models Analysis|Statistical significance was defined by a P-value \< 0.05. No adjustments were made for multiplicity.||||||= 0.1842
72517463|NCT02157506|144564721|SUPERIORITY||||||=|0.3328|||||||Mixed Models Analysis|Statistical significance was defined by a P-value \< 0.05. No adjustments were made for multiplicity.||||||= 0.3328
72517464|NCT02157506|144564721|SUPERIORITY||||||=|0.1465|||||||Mixed Models Analysis|Statistical significance was defined by a P-value \< 0.05. No adjustments were made for multiplicity.||||||= 0.1465
72517465|NCT02157506|144564721|SUPERIORITY||||||=|0.2799|||||||Mixed Models Analysis|Statistical significance was defined by a P-value \< 0.05. No adjustments were made for multiplicity.||||||= 0.2799
72517466|NCT02157506|144564722|SUPERIORITY||||||=|0.2499|||||||Mixed Models Analysis|Statistical significance was defined by a P-value \< 0.05. No adjustments were made for multiplicity.||||||= 0.2499
72517467|NCT02157506|144564722|SUPERIORITY||||||=|0.8281|||||||Mixed Models Analysis|Statistical significance was defined by a P-value \< 0.05. No adjustments were made for multiplicity.||||||= 0.8281
72517468|NCT02157506|144564722|SUPERIORITY||||||=|0.4121|||||||Mixed Models Analysis|Statistical significance was defined by a P-value \< 0.05. No adjustments were made for multiplicity.||||||= 0.4121
72517469|NCT02157506|144564722|SUPERIORITY||||||=|0.8592|||||||Mixed Models Analysis|Statistical significance was defined by a P-value \< 0.05. No adjustments were made for multiplicity.||||||= 0.8592
72517470|NCT02157506|144564723|SUPERIORITY||||||=|0.1391|||||||Mixed Models Analysis|Statistical significance was defined by a P-value \< 0.05. No adjustments were made for multiplicity.||||||= 0.1391
72517471|NCT02157506|144564723|SUPERIORITY||||||=|0.1724|||||||Mixed Models Analysis|Statistical significance was defined by a P-value \< 0.05. No adjustments were made for multiplicity.||||||= 0.1724
72517472|NCT02157506|144564723|SUPERIORITY||||||=|0.1245|||||||Mixed Models Analysis|Statistical significance was defined by a P-value \< 0.05. No adjustments were made for multiplicity.||||||= 0.1245
72517473|NCT02157506|144564723|SUPERIORITY||||||=|0.169|||||||Mixed Models Analysis|Statistical significance was defined by a P-value \< 0.05. No adjustments were made for multiplicity.||||||= 0.1690
72517474|NCT02157506|144564724|SUPERIORITY||||||=|0.4936|||||||Mixed Models Analysis|Statistical significance was defined by a P-value \< 0.05. No adjustments were made for multiplicity.||||||= 0.4936
72517475|NCT02157506|144564724|SUPERIORITY||||||=|0.992|||||||Mixed Models Analysis|Statistical significance was defined by a P-value \< 0.05. No adjustments were made for multiplicity.||||||= 0.9920
72517476|NCT02157506|144564724|SUPERIORITY||||||=|0.2789|||||||Mixed Models Analysis|Statistical significance was defined by a P-value \< 0.05. No adjustments were made for multiplicity.||||||= 0.2789
72517477|NCT02157506|144564724|SUPERIORITY||||||=|0.91|||||||Mixed Models Analysis|Statistical significance was defined by a P-value \< 0.05. No adjustments were made for multiplicity.||||||= 0.9100
72517478|NCT01021813|144564732|SUPERIORITY_OR_OTHER||Difference in Percentage|0.4|||||TWO_SIDED|95.0|-1.1|1.4|||Miettinen & Nurminen Method.|||The method of Miettinen and Nurminen was used to construct the confidence interval for the difference in the percentage of participants with any sleep paralysis AEs between the Suvorexant group and Placebo group .||1.4|-1.1|
72517479|NCT01021813|144564733|SUPERIORITY_OR_OTHER||Difference in Percentage|0.2||||0.482|TWO_SIDED|95.0|-1.3|1.1|||Miettinen & Nurminen Method.|||The method of Miettinen and Nurminen was used to construct the confidence interval for the difference in the percentage of participants with any complex sleep-related behaviors AEs between the Suvorexant group and Placebo group.||1.1|-1.3|0.482
72517480|NCT01021813|144564734|SUPERIORITY_OR_OTHER||Difference in Percentage|-0.8||||0.508|TWO_SIDED|95.0|-3.9|1.5|||Miettinen & Nurminen Method|||The method of Miettinen and Nurminen was used to calculate the p-value and construct the confidence interval for the difference in the percentage of participants with any falls AEs between the Suvorexant group and Placebo group.||1.5|-3.9|0.508
72517481|NCT01021813|144564735|SUPERIORITY_OR_OTHER||Difference in Percentage of AEs|0.8||||0.159|TWO_SIDED|95.0|-0.7|2.0|||Miettinen & Nurminen Method|||The method of Miettinen and Nurminen was used to calculate the p-value and construct the confidence interval for the difference in the percentage of participants with any suicidal ideation/behavior AEs considered an ECI between the Suvorexant group and Placebo group.||2.0|-0.7|0.159
72517482|NCT01021813|144564736|SUPERIORITY_OR_OTHER||Difference in Percentage|0.8||||0.159|TWO_SIDED|95.0|-0.7|2.0|||Miettinen & Nurminen Method|||The method of Miettinen and Nurminen was used to calculate the p-value and construct the confidence interval for the difference in the percentage of participants with any Hypnagogic/hypnopompic hallucinations AEs between the Suvorexant group and Placebo group.||2.0|-0.7|0.159
72517483|NCT01021813|144564737|SUPERIORITY_OR_OTHER||Difference in Percentage|-0.4||||0.767|TWO_SIDED|95.0|-3.8|2.2|||Miettinen & Nurminen Method|||The method of Miettinen and Nurminen was used to calculate the p-value and construct the confidence interval for the difference in the percentage of participants with any selected AEs associated with potential abuse between the Suvorexant group and Placebo group.||2.2|-3.8|0.767
72517484|NCT01021813|144564738|SUPERIORITY_OR_OTHER||Difference in Percentage: Night 1|-0.81||||0.567|TWO_SIDED|95.0|-5.1|3.1|||Miettinen & Nurminen Method|||The method of Miettinen and Nurminen was used to calculate the p-value and compute the confidence interval for the point difference in a pairwise comparison of the percentage of participants with withdrawal symptoms during Night 1 in the Suvorexant (DB Treatment)/Suvorexant (DB Discontinuation) group vs. the Suvorexant (DB Treatment)/Placebo (DB Discontinuation) group.||3.1|-5.1|0.567
72405068|NCT01336738|144317500|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.137||0.002|TWO_SIDED|80.0|-0.57|-0.22||One-sided p-value was calculated.|Mixed Models Analysis|||Week 8: Treatment difference and 80% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction as the covariates, time was repeated for participant.||-0.22|-0.57|0.0020
72491723|NCT00533442|144511836|SUPERIORITY|||||||0.47|||||||t-test, 2 sided|||Comparison of Mean Log {C-Peptide Level} at 12 Months Post-Transplant (t-test).||||.47
72569328|NCT00444457|144669740|NON_INFERIORITY_OR_EQUIVALENCE|Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|-0.7|||||TWO_SIDED|95.0|-2.69|1.19||||||Additional serotypes - serotype 19A||1.19|-2.69|
72491724|NCT00533442|144511836|SUPERIORITY|||||||0.97|||||||t-test, 2 sided|||Comparison of Mean Log {C-Peptide Level} at 36 Months Post-Transplant (t-test).||||0.97
72491725|NCT00533442|144511836|SUPERIORITY|||||||0.75|||||||t-test, 2 sided|||Comparison of Mean Log {C-Peptide Level} at 60 Months Post-Transplant (t-test).||||0.75
72491726|NCT01119248|144511840|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|STANDARD_DEVIATION|0.62|<|0.001|TWO_SIDED|95.0|-0.48|-0.25|||t-test, 2 sided|||||-0.25|-0.48|<.001
72491727|NCT01119248|144511841|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.69||||0.0001|TWO_SIDED|95.0|-0.95|-0.43|||t-test, 2 sided|||pre- MRI body temperature was associated with change in body temperature after MRI by bivariate analysis. The values presented are adjusted for body surface area, type of MRI, room temperature and duration of MRI||-0.43|-0.95|0.0001
72491728|NCT01119248|144511842|SUPERIORITY_OR_OTHER|||||||0.001|||||||t-test, 2 sided|||||||0.001
72491729|NCT00562354|144511853|SUPERIORITY_OR_OTHER||ratio of geometric mean titer|0.6|||||TWO_SIDED|95.0|0.39|0.84|||||Ratio of GMTs were calculated by back transformation of the mean difference between age groups on the logarithmic scale.|Serotype 1: To assess differences between reporting groups, 2-sided 95% CIs for the ratio of OPA GMTs were constructed by back transformation of the CIs for the mean difference of the log-transformed assay results computed using the Student t-distribution.||0.84|0.39|
72491730|NCT00562354|144511853|SUPERIORITY_OR_OTHER||ratio of geometric mean titer|0.7|||||TWO_SIDED|95.0|0.54|1.01|||||Ratio of GMTs were calculated by back transformation of the mean difference between age groups on the logarithmic scale.|Serotype 3: To assess differences between reporting groups, 2-sided 95% CIs for the ratio of OPA GMTs were constructed by back transformation of the CIs for the mean difference of the log-transformed assay results computed using the Student t-distribution.||1.01|0.54|
72491731|NCT00562354|144511853|SUPERIORITY_OR_OTHER||ratio of geometric mean titer|0.7|||||TWO_SIDED|95.0|0.5|1.11|||||Ratio of GMTs were calculated by back transformation of the mean difference between age groups on the logarithmic scale.|Serotype 4: To assess differences between reporting groups, 2-sided 95% CIs for the ratio of OPA GMTs were constructed by back transformation of the CIs for the mean difference of the log-transformed assay results computed using the Student t-distribution.||1.11|0.50|
72491732|NCT00562354|144511853|SUPERIORITY_OR_OTHER||ratio of geometric mean titer|0.6|||||TWO_SIDED|95.0|0.38|0.9|||||Ratio of GMTs were calculated by back transformation of the mean difference between age groups on the logarithmic scale.|Serotype 5: To assess differences between reporting groups, 2-sided 95% CIs for the ratio of OPA GMTs were constructed by back transformation of the CIs for the mean difference of the log-transformed assay results computed using the Student t-distribution.||0.90|0.38|
72491733|NCT00562354|144511853|SUPERIORITY_OR_OTHER||ratio of geometric mean titer|0.5|||||TWO_SIDED|95.0|0.37|0.74|||||Ratio of GMTs were calculated by back transformation of the mean difference between age groups on the logarithmic scale.|Serotype 6A: To assess differences between reporting groups, 2-sided 95% CIs for the ratio of OPA GMTs were constructed by back transformation of the CIs for the mean difference of the log-transformed assay results computed using the Student t-distribution.||0.74|0.37|
72491734|NCT00562354|144511853|SUPERIORITY_OR_OTHER||ratio of geometric mean titer|0.7|||||TWO_SIDED|95.0|0.52|1.02|||||Ratio of GMTs were calculated by back transformation of the mean difference between age groups on the logarithmic scale.|Serotype 6B: To assess differences between reporting groups, 2-sided 95% CIs for the ratio of OPA GMTs were constructed by back transformation of the CIs for the mean difference of the log-transformed assay results computed using the Student t-distribution.||1.02|0.52|
72491735|NCT00562354|144511853|SUPERIORITY_OR_OTHER||ratio of geometric mean titer|0.7|||||TWO_SIDED|95.0|0.46|0.95|||||Ratio of GMTs were calculated by back transformation of the mean difference between age groups on the logarithmic scale.|Serotype 7F: To assess differences between reporting groups, 2-sided 95% CIs for the ratio of OPA GMTs were constructed by back transformation of the CIs for the mean difference of the log-transformed assay results computed using the Student t-distribution.||0.95|0.46|
72491736|NCT00562354|144511853|SUPERIORITY_OR_OTHER||ratio of geometric mean titer|0.7|||||TWO_SIDED|95.0|0.45|1.25|||||Ratio of GMTs were calculated by back transformation of the mean difference between age groups on the logarithmic scale.|Serotype 9V: To assess differences between reporting groups, 2-sided 95% CIs for the ratio of OPA GMTs were constructed by back transformation of the CIs for the mean difference of the log-transformed assay results computed using the Student t-distribution.||1.25|0.45|
72491737|NCT00562354|144511853|SUPERIORITY_OR_OTHER||ratio of geometric mean titer|0.7|||||TWO_SIDED|95.0|0.54|1.02|||||Ratio of GMTs were calculated by back transformation of the mean difference between age groups on the logarithmic scale.|Serotype 14: To assess differences between reporting groups, 2-sided 95% CIs for the ratio of OPA GMTs were constructed by back transformation of the CIs for the mean difference of the log-transformed assay results computed using the Student t-distribution.||1.02|0.54|
72491738|NCT00562354|144511853|SUPERIORITY_OR_OTHER||ratio of geometric mean titer|0.5|||||TWO_SIDED|95.0|0.35|0.79|||||Ratio of GMTs were calculated by back transformation of the mean difference between age groups on the logarithmic scale.|Serotype 18C: To assess differences between reporting groups, 2-sided 95% CIs for the ratio of OPA GMTs were constructed by back transformation of the CIs for the mean difference of the log-transformed assay results computed using the Student t-distribution.||0.79|0.35|
72491739|NCT00562354|144511853|SUPERIORITY_OR_OTHER||ratio of geometric mean titer|0.5|||||TWO_SIDED|95.0|0.34|0.67|||||Ratio of GMTs were calculated by back transformation of the mean difference between age groups on the logarithmic scale.|Serotype 19A: To assess differences between reporting groups, 2-sided 95% CIs for the ratio of OPA GMTs were constructed by back transformation of the CIs for the mean difference of the log-transformed assay results computed using the Student t-distribution.||0.67|0.34|
72405069|NCT01336738|144317500|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.58|STANDARD_ERROR_OF_MEAN|0.138|<|0.0001|TWO_SIDED|80.0|-0.76|-0.41||One-sided p-value was calculated.|Mixed Models Analysis|||Week 8: Treatment difference and 80% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction as the covariates, time was repeated for participant.||-0.41|-0.76|<0.0001
72405070|NCT01336738|144317500|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.59|STANDARD_ERROR_OF_MEAN|0.133|<|0.0001|TWO_SIDED|80.0|-0.76|-0.42||One-sided p-value was calculated.|Mixed Models Analysis|||Week 8: Treatment difference and 80% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction as the covariates, time was repeated for participant.||-0.42|-0.76|<0.0001
72405071|NCT01336738|144317502|SUPERIORITY_OR_OTHER||LS Mean Difference|0.28|STANDARD_ERROR_OF_MEAN|0.225||0.2067|TWO_SIDED|95.0|-0.16|0.73||Two-sided p-value was calculated.|Mixed Models Analysis|||Week 1: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.73|-0.16|0.2067
72405072|NCT01336738|144317502|SUPERIORITY_OR_OTHER||LS Mean Difference|0.04|STANDARD_ERROR_OF_MEAN|0.224||0.8602|TWO_SIDED|95.0|-0.4|0.48||Two-sided p-value was calculated.|Mixed Models Analysis|||Week 1: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.48|-0.40|0.8602
72405073|NCT01336738|144317502|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.225||0.92|TWO_SIDED|95.0|-0.47|0.42||Two-sided p-value was calculated.|Mixed Models Analysis|||Week 1: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.42|-0.47|0.9200
72491740|NCT00562354|144511853|SUPERIORITY_OR_OTHER||ratio of geometric mean titer|0.6|||||TWO_SIDED|95.0|0.37|0.88|||||Confidence intervals for the ratio are back transformation of the CIs based on the Student t distribution for the mean difference of the logarithmically transformed assay results.|Serotype 19F: To assess differences between reporting groups, 2-sided 95% CIs for the ratio of OPA GMTs were constructed by back transformation of the CIs for the mean difference of the log-transformed assay results computed using the Student t-distribution.||0.88|0.37|
72491741|NCT00562354|144511853|SUPERIORITY_OR_OTHER||ratio of geometric mean titer|0.5|||||TWO_SIDED|95.0|0.3|0.79|||||Ratio of GMTs were calculated by back transformation of the mean difference between age groups on the logarithmic scale.|Serotype 23F: To assess differences between reporting groups, 2-sided 95% CIs for the ratio of OPA GMTs were constructed by back transformation of the CIs for the mean difference of the log-transformed assay results computed using the Student t-distribution.||0.79|0.30|
72491742|NCT00562354|144511856|SUPERIORITY_OR_OTHER||difference in proportions|-4.9|||||TWO_SIDED|95.0|-12.1|2.0||||||Serotype 1: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).||2.0|-12.1|
72491743|NCT00562354|144511856|SUPERIORITY_OR_OTHER||difference in proportions|-3.9|||||TWO_SIDED|95.0|-11.6|3.5||||||Serotype 3: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).||3.5|-11.6|
72517485|NCT01021813|144564738|SUPERIORITY_OR_OTHER||Difference in Percentage: Night 2|-2.4||||0.185|TWO_SIDED|95.0|-7.3|1.6|||Miettinen & Nurminen Method|||The method of Miettinen and Nurminen was used to calculate the p-value and compute the confidence interval for the point difference in a pairwise comparison of the percentage of participants with withdrawal symptoms during Night 2 in the Suvorexant (DB Treatment)/Suvorexant (DB Discontinuation) group vs. the Suvorexant (DB Treatment)/Placebo (DB Discontinuation) group.||1.6|-7.3|0.185
72517486|NCT01021813|144564738|SUPERIORITY_OR_OTHER||Difference in Percentage: Night 3|-0.78||||0.68|TWO_SIDED|95.0|-5.6|3.9|||Miettinen & Nurminen Method|||The method of Miettinen and Nurminen was used to calculate the p-value and compute the confidence interval for the point difference in a pairwise comparison of the percentage of participants with withdrawal symptoms during Night 3 in the Suvorexant (DB Treatment)/Suvorexant (DB Discontinuation) group vs. the Suvorexant (DB Treatment)/Placebo (DB Discontinuation) group.||3.9|-5.6|0.680
72491744|NCT00562354|144511856|SUPERIORITY_OR_OTHER||difference in proportions|-3.4|||||TWO_SIDED|95.0|-9.6|2.2||||||Serotype 4: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).||2.2|-9.6|
72491745|NCT00562354|144511856|SUPERIORITY_OR_OTHER||difference in proportions|-5.5|||||TWO_SIDED|95.0|-13.7|2.5||||||Serotype 5: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).||2.5|-13.7|
72517487|NCT01021813|144564738|SUPERIORITY_OR_OTHER||Difference in Percentage: Across Nights|0.0||||1|TWO_SIDED|95.0|-6.4|6.4|||Miettinen & Nurminen Method|||The method of Miettinen and Nurminen was used to calculate the p-value and compute the confidence interval for the point difference in a pairwise comparison of the percentage of participants with withdrawal symptoms across Nights 1, 2, and 3 in the Suvorexant (DB Treatment)/Suvorexant (DB Discontinuation) group vs. the Suvorexant (DB Treatment)/Placebo (DB Discontinuation) group.||6.4|-6.4|1.000
72405074|NCT01336738|144317502|SUPERIORITY_OR_OTHER||LS Mean Difference|0.46|STANDARD_ERROR_OF_MEAN|0.223||0.0399|TWO_SIDED|95.0|0.02|0.9||Two-sided p-value was calculated.|Mixed Models Analysis|||Week 1: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.90|0.02|0.0399
72405075|NCT01336738|144317502|SUPERIORITY_OR_OTHER||LS Mean Difference|0.29|STANDARD_ERROR_OF_MEAN|0.242||0.2266|TWO_SIDED|95.0|-0.18|0.77||Two-sided p-value was calculated.|Mixed Models Analysis|||Week 2: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.77|-0.18|0.2266
72405076|NCT01336738|144317502|SUPERIORITY_OR_OTHER||LS Mean Difference|0.05|STANDARD_ERROR_OF_MEAN|0.241||0.8493|TWO_SIDED|95.0|-0.43|0.52||Two-sided p-value was calculated.|Mixed Models Analysis|||Week 2: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.52|-0.43|0.8493
72405077|NCT01336738|144317502|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.242||0.9511|TWO_SIDED|95.0|-0.49|0.46||Two-sided p-value was calculated.|Mixed Models Analysis|||Week 2: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.46|-0.49|0.9511
72405078|NCT01336738|144317502|SUPERIORITY_OR_OTHER||LS Mean Difference|0.36|STANDARD_ERROR_OF_MEAN|0.241||0.1369|TWO_SIDED|95.0|-0.11|0.83||Two-sided p-value was calculated.|Mixed Models Analysis|||Week 2: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.83|-0.11|0.1369
72405079|NCT01336738|144317502|SUPERIORITY_OR_OTHER||LS Mean Difference|0.39|STANDARD_ERROR_OF_MEAN|0.272||0.1562|TWO_SIDED|95.0|-0.15|0.92||Two-sided p-value was calculated.|Mixed Models Analysis|||Week 4: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.92|-0.15|0.1562
72405080|NCT01336738|144317502|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.272||0.4913|TWO_SIDED|95.0|-0.72|0.35||Two-sided p-value was calculated.|Mixed Models Analysis|||Week 4: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.35|-0.72|0.4913
72405081|NCT01336738|144317502|SUPERIORITY_OR_OTHER||LS Mean Difference|0.18|STANDARD_ERROR_OF_MEAN|0.272||0.513|TWO_SIDED|95.0|-0.36|0.71||Two-sided p-value was calculated.|Mixed Models Analysis|||Week 4: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.71|-0.36|0.5130
72517488|NCT01021813|144564739|SUPERIORITY_OR_OTHER||Difference in Percentage: Night 1|5.03||||0.365|TWO_SIDED|95.0|-5.8|15.8|||Miettinen & Nurminen Method|||The method of Miettinen and Nurminen was used to calculate the p-value and compute the confidence interval for the point difference in a pairwise comparison of the percentage of participants with sTST rebound effects during Night 1 in the Suvorexant (DB Treatment)/Suvorexant (DB Discontinuation) group vs. the Placebo (DB Treatment)/Placebo (DB Discontinuation) group.||15.8|-5.8|0.365
72517489|NCT01021813|144564739|SUPERIORITY_OR_OTHER||Difference in Percentage: Night 2|8.72||||0.109|TWO_SIDED|95.0|-2.0|19.2|||Miettinen & Nurminen Method|||The method of Miettinen and Nurminen was used to calculate the p-value and compute the confidence interval for the point difference in a pairwise comparison of the percentage of participants with sTST rebound effects during Night 2 in the Suvorexant (DB Treatment)/Suvorexant (DB Discontinuation) group vs. the Placebo (DB Treatment)/Placebo (DB Discontinuation) group.||19.2|-2.0|0.109
72517490|NCT01021813|144564739|SUPERIORITY_OR_OTHER||Difference in Percentage: Night 3|6.02||||0.287|TWO_SIDED|95.0|-5.1|16.9|||Miettinen & Nurminen Method|||The method of Miettinen and Nurminen was used to calculate the p-value and compute the confidence interval for the point difference in a pairwise comparison of the percentage of participants with sTST rebound effects during Night 3 in the Suvorexant (DB Treatment)/Suvorexant (DB Discontinuation) group vs. the Placebo (DB Treatment)/Placebo (DB Discontinuation) group.||16.9|-5.1|0.287
72517491|NCT01021813|144564739|SUPERIORITY_OR_OTHER||Difference in Percentage:Night 1, 2 or 3|10.82||||0.057|TWO_SIDED|95.0|-0.3|21.7|||Miettinen & Nurminen Method|||The method of Miettinen and Nurminen was used to calculate the p-value and compute the confidence interval for the point difference in a pairwise comparison of the percentage of participants with sTST rebound effects during Nights 1, 2, or 3 in the Suvorexant (DB Treatment)/Suvorexant (DB Discontinuation) group vs. the Placebo (DB Treatment)/Placebo (DB Discontinuation) group.||21.7|-0.3|0.057
72405082|NCT01336738|144317502|SUPERIORITY_OR_OTHER||LS Mean Difference|0.59|STANDARD_ERROR_OF_MEAN|0.269||0.0298|TWO_SIDED|95.0|0.06|1.12||Two-sided p-value was calculated.|Mixed Models Analysis|||Week 4: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||1.12|0.06|0.0298
72405083|NCT01336738|144317502|SUPERIORITY_OR_OTHER||LS Mean Difference|0.36|STANDARD_ERROR_OF_MEAN|0.363||0.3196|TWO_SIDED|95.0|-0.35|1.08||Two-sided p-value was calculated.|Mixed Models Analysis|||Week 8: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||1.08|-0.35|0.3196
72569329|NCT00444457|144669740|NON_INFERIORITY_OR_EQUIVALENCE|Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|0.3|||||TWO_SIDED|95.0|-1.4|2.04||||||Additional serotypes - serotype 19A||2.04|-1.40|
72405084|NCT01336738|144317502|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.367||0.8884|TWO_SIDED|95.0|-0.77|0.67||Two-sided p-value was calculated.|Mixed Models Analysis|||Week 8: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.67|-0.77|0.8884
72405085|NCT01336738|144317502|SUPERIORITY_OR_OTHER||LS Mean Difference|0.12|STANDARD_ERROR_OF_MEAN|0.365||0.7325|TWO_SIDED|95.0|-0.59|0.84||Two-sided p-value was calculated.|Mixed Models Analysis|||Week 8: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.84|-0.59|0.7325
72405086|NCT01336738|144317502|SUPERIORITY_OR_OTHER||LS Mean Difference|0.34|STANDARD_ERROR_OF_MEAN|0.357||0.3395|TWO_SIDED|95.0|-0.36|1.04||Two-sided p-value was calculated.|Mixed Models Analysis|||Week 8: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||1.04|-0.36|0.3395
72491746|NCT00562354|144511856|SUPERIORITY_OR_OTHER||difference in proportions|-1.5|||||TWO_SIDED|95.0|-5.7|2.1||||||Serotype 6A: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).||2.1|-5.7|
72491747|NCT00562354|144511856|SUPERIORITY_OR_OTHER||difference in proportions|-1.6|||||TWO_SIDED|95.0|-5.9|2.1||||||Serotype 6B: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).||2.1|-5.9|
72491748|NCT00562354|144511856|SUPERIORITY_OR_OTHER||difference in proportions|-5.3|||||TWO_SIDED|95.0|-10.8|-0.9||||||Serotype 7F: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).||-0.9|-10.8|
72491749|NCT00562354|144511856|SUPERIORITY_OR_OTHER||difference in proportions|-0.8|||||TWO_SIDED|95.0|-8.7|6.9||||||Serotype 9V: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).||6.9|-8.7|
72491750|NCT00562354|144511856|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-4.0|4.1||||||Serotype 14: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).||4.1|-4.0|
72491751|NCT00562354|144511856|SUPERIORITY_OR_OTHER||difference in proportions|-2.3|||||TWO_SIDED|95.0|-7.6|2.5||||||Serotype 18C: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).||2.5|-7.6|
72491752|NCT00562354|144511856|SUPERIORITY_OR_OTHER||difference in proportions|0.8|||||TWO_SIDED|95.0|-2.8|4.7||||||Serotype 19A: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).||4.7|-2.8|
72491753|NCT00562354|144511856|SUPERIORITY_OR_OTHER||difference in proportions|-2.4|||||TWO_SIDED|95.0|-8.8|3.7||||||Serotype 19F: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).||3.7|-8.8|
72491754|NCT00562354|144511856|SUPERIORITY_OR_OTHER||difference in proportions|-6.2|||||TWO_SIDED|95.0|-14.1|1.5||||||Serotype 23F: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).||1.5|-14.1|
72491755|NCT00562354|144511859|SUPERIORITY_OR_OTHER||difference in proportions|-7.2|||||TWO_SIDED|95.0|-15.1|0.3||||||Serotype 1: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).||0.3|-15.1|
72491756|NCT00562354|144511859|SUPERIORITY_OR_OTHER||difference in proportions|-5.4|||||TWO_SIDED|95.0|-14.5|3.5||||||Serotype 3: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).||3.5|-14.5|
72491757|NCT00562354|144511859|SUPERIORITY_OR_OTHER||difference in proportions|-11.2|||||TWO_SIDED|95.0|-21.4|-1.0||||||Serotype 4: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).||-1.0|-21.4|
72491758|NCT00562354|144511859|SUPERIORITY_OR_OTHER||difference in proportions|-4.7|||||TWO_SIDED|95.0|-13.5|3.9||||||Serotype 5: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).||3.9|-13.5|
72517492|NCT01021813|144564740|SUPERIORITY_OR_OTHER||Difference in Percentage: Night 1|4.46||||0.386|TWO_SIDED|95.0|-5.7|14.5|||Miettinen & Nurminen Method|||The method of Miettinen and Nurminen was used to calculate the p-value and compute the confidence interval for the point difference in a pairwise comparison of the percentage of participants with sTSO rebound effects during Night 1 in the Suvorexant (DB Treatment)/Suvorexant (DB Discontinuation) group vs. the Placebo (DB Treatment)/Placebo (DB Discontinuation) group.||14.5|-5.7|0.386
72517493|NCT01021813|144564740|SUPERIORITY_OR_OTHER||Difference in Percentage: Night 2|5.31||||0.311|TWO_SIDED|95.0|-5.0|15.5|||Miettinen & Nurminen Method|||The method of Miettinen and Nurminen was used to calculate the p-value and compute the confidence interval for the point difference in a pairwise comparison of the percentage of participants with sTSO rebound effects during Night 2 in the Suvorexant (DB Treatment)/Suvorexant (DB Discontinuation) group vs. the Placebo (DB Treatment)/Placebo (DB Discontinuation) group.||15.5|-5.0|0.311
72491759|NCT00562354|144511859|SUPERIORITY_OR_OTHER||difference in proportions|-5.1|||||TWO_SIDED|95.0|-14.3|4.0||||||Serotype 6A: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).||4.0|-14.3|
72491760|NCT00562354|144511859|SUPERIORITY_OR_OTHER||difference in proportions|-12.9|||||TWO_SIDED|95.0|-24.6|-0.8||||||Serotype 6B: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).||-0.8|-24.6|
72491761|NCT00562354|144511859|SUPERIORITY_OR_OTHER||difference in proportions|-7.3|||||TWO_SIDED|95.0|-16.3|1.5||||||Serotype 7F: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).||1.5|-16.3|
72491762|NCT00562354|144511859|SUPERIORITY_OR_OTHER||difference in proportions|-17.5|||||TWO_SIDED|95.0|-29.5|-5.0||||||Serotype 9V: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).||-5.0|-29.5|
72624780|NCT01346592|144778966|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (B strain)|2.5|||||TWO_SIDED|95.0|1.34|4.67||||||At risk subjects.||4.67|1.34|
72624781|NCT01346592|144778966|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (H1N1 strain)|3.33|||||TWO_SIDED|95.0|2.77|4.01||||||No risk subjects.||4.01|2.77|
72517494|NCT01021813|144564740|SUPERIORITY_OR_OTHER||Difference in Percentage: Night 3|4.96||||0.351|TWO_SIDED|95.0|-5.5|15.3|||Miettinen & Nurminen Method|||The method of Miettinen and Nurminen was used to calculate the p-value and compute the confidence interval for the point difference in a pairwise comparison of the percentage of participants with sTSO rebound effects during Night 3 in the Suvorexant (DB Treatment)/Suvorexant (DB Discontinuation) group vs. the Placebo (DB Treatment)/Placebo (DB Discontinuation) group.||15.3|-5.5|0.351
72517495|NCT01021813|144564740|SUPERIORITY_OR_OTHER||Difference in Percentage:Night 1, 2 or 3|4.58||||0.409|TWO_SIDED|95.0|-6.3|15.3|||Miettinen & Nurminen Method|||The method of Miettinen and Nurminen was used to calculate the p-value and compute the confidence interval for the point difference in a pairwise comparison of the percentage of participants with sTSO rebound effects during Nights 1, 2, or 3 in the Suvorexant (DB Treatment)/Suvorexant (DB Discontinuation) group vs. the Placebo (DB Treatment)/Placebo (DB Discontinuation) group.||15.3|-6.3|0.409
72569330|NCT00444457|144669741|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|0.1|||||TWO_SIDED|95.0|-1.61|1.81|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Common serotypes - serotype 4||1.81|-1.61|
72569331|NCT00444457|144669741|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|-0.8|||||TWO_SIDED|95.0|-2.39|0.23|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Common serotypes - serotype 4||0.23|-2.39|
72569332|NCT00444457|144669741|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|-0.9|||||TWO_SIDED|95.0|-2.54|0.2|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Common serotypes - serotype 4||0.20|-2.54|
72569333|NCT00444457|144669741|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|0.0|||||TWO_SIDED|95.0|-1.02|1.11|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Common serotypes - serotype 6B||1.11|-1.02|
72405087|NCT01336738|144317502|SUPERIORITY_OR_OTHER||LS Mean Difference|0.13|STANDARD_ERROR_OF_MEAN|0.41||0.7514|TWO_SIDED|95.0|-0.68|0.94||Two-sided p-value was calculated.|Mixed Models Analysis|||Week 12: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.94|-0.68|0.7514
72491763|NCT00562354|144511859|SUPERIORITY_OR_OTHER||difference in proportions|-9.6|||||TWO_SIDED|95.0|-21.4|2.4||||||Serotype 14: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).||2.4|-21.4|
72491764|NCT00562354|144511859|SUPERIORITY_OR_OTHER||difference in proportions|-10.5|||||TWO_SIDED|95.0|-19.3|-1.3||||||Serotype 18C: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).||-1.3|-19.3|
72491765|NCT00562354|144511859|SUPERIORITY_OR_OTHER||difference in proportions|0.8|||||TWO_SIDED|95.0|-6.2|7.9||||||Serotype 19A: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).||7.9|-6.2|
72491766|NCT00562354|144511859|SUPERIORITY_OR_OTHER||difference in proportions|-3.8|||||TWO_SIDED|95.0|-12.2|4.5||||||Serotype 19F: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).||4.5|-12.2|
72491767|NCT00562354|144511859|SUPERIORITY_OR_OTHER||difference in proportions|-2.5|||||TWO_SIDED|95.0|-12.5|7.3||||||Serotype 23F: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).||7.3|-12.5|
72491768|NCT00562354|144511862|SUPERIORITY_OR_OTHER||difference in proportions|-5.7|||||TWO_SIDED|95.0|-13.8|2.1||||||Serotype 1: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).||2.1|-13.8|
72491769|NCT00562354|144511862|SUPERIORITY_OR_OTHER||difference in proportions|-5.5|||||TWO_SIDED|95.0|-15.9|5.0||||||Serotype 3: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).||5.0|-15.9|
72491770|NCT00562354|144511862|SUPERIORITY_OR_OTHER||difference in proportions|-18.3|||||TWO_SIDED|95.0|-30.1|-5.9||||||Serotype 4: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).||-5.9|-30.1|
72491771|NCT00562354|144511862|SUPERIORITY_OR_OTHER||difference in proportions|-2.3|||||TWO_SIDED|95.0|-11.6|6.9||||||Serotype 5: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).||6.9|-11.6|
72491772|NCT00562354|144511862|SUPERIORITY_OR_OTHER||difference in proportions|-11.9|||||TWO_SIDED|95.0|-22.6|-1.2||||||Serotype 6A: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).||-1.2|-22.6|
72491773|NCT00562354|144511862|SUPERIORITY_OR_OTHER||difference in proportions|-11.0|||||TWO_SIDED|95.0|-23.8|1.9||||||Serotype 6B: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).||1.9|-23.8|
72491774|NCT00562354|144511862|SUPERIORITY_OR_OTHER||difference in proportions|-9.5|||||TWO_SIDED|95.0|-19.3|0.4||||||Serotype 7F: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).||0.4|-19.3|
72569334|NCT00444457|144669741|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|0.0|||||TWO_SIDED|95.0|-1.03|1.04|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Common serotypes - serotype 6B||1.04|-1.03|
72491775|NCT00562354|144511862|SUPERIORITY_OR_OTHER||difference in proportions|-26.9|||||TWO_SIDED|95.0|-39.0|-14.1||||||Serotype 9V: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).||-14.1|-39.0|
72491776|NCT00562354|144511862|SUPERIORITY_OR_OTHER||difference in proportions|-6.4|||||TWO_SIDED|95.0|-18.7|6.1||||||Serotype 14: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).||6.1|-18.7|
72569335|NCT00444457|144669741|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|0.0|||||TWO_SIDED|95.0|-1.13|1.06|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Common serotypes - serotype 6B||1.06|-1.13|
72569336|NCT00444457|144669741|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|0.0|||||TWO_SIDED|95.0|-1.25|1.37|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Common serotypes - serotype 9V||1.37|-1.25|
72491777|NCT00562354|144511862|SUPERIORITY_OR_OTHER||difference in proportions|-12.2|||||TWO_SIDED|95.0|-22.6|-1.7||||||Serotype 18C: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).||-1.7|-22.6|
72569337|NCT00444457|144669741|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|0.6|||||TWO_SIDED|95.0|-0.76|2.18|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Common serotypes - serotype 9V||2.18|-0.76|
72491778|NCT00562354|144511862|SUPERIORITY_OR_OTHER||difference in proportions|-0.8|||||TWO_SIDED|95.0|-9.8|8.1||||||Serotype 19A: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).||8.1|-9.8|
72491779|NCT00562354|144511862|SUPERIORITY_OR_OTHER||difference in proportions|-11.4|||||TWO_SIDED|95.0|-21.7|-1.2||||||Serotype 19F: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).||-1.2|-21.7|
72491780|NCT00562354|144511862|SUPERIORITY_OR_OTHER||difference in proportions|-7.7|||||TWO_SIDED|95.0|-18.5|3.4||||||Serotype 23F: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).||3.4|-18.5|
72491781|NCT00562354|144511865|SUPERIORITY_OR_OTHER||ratio of geometric mean concentration|0.6|||||TWO_SIDED|95.0|0.43|0.86|||||Ratio of GMCs were calculated by back transformation of the mean difference between age groups on the logarithmic scale.|Serotype 1: To assess differences between reporting groups, 2-sided 95% CIs for the ratio of IgG GMCs were constructed by back transformation of the CIs for the mean difference of the log-transformed assay results computed using the Student t-distribution.||0.86|0.43|
72517496|NCT01021813|144564741|SUPERIORITY_OR_OTHER||Difference in LS Means: Month 1|22.7|||<|0.0001|TWO_SIDED|95.0|16.4|29.0||To account for multiplicity, Hochberg's procedure was used to control the overall Type I error rate at the 5% level.|Longitudinal Data Analysis|||A Longitudinal Data Analysis Model was used to test the difference in LS mean change from baseline in sTSTm for Month 1 (Average of Weeks 1, 2, 3, 4) in the Suvorexant group vs. the Placebo group.||29.0|16.4|<0.0001
72517497|NCT01021813|144564742|SUPERIORITY_OR_OTHER||Difference in LS Means: Month 1|-9.5||||0.0002|TWO_SIDED|95.0|-14.6|-4.5||To account for multiplicity, Hochberg's procedure was used to control the overall Type I error rate at the 5% level.|Longitudinal Data Analysis|||A Longitudinal Data Analysis Model was used to test the difference in LS mean change from baseline in sTSOm for Month 1 (Average of Weeks 1, 2, 3, 4) in the Suvorexant group vs. the Placebo group.||-4.5|-14.6|0.0002
72491782|NCT00562354|144511865|SUPERIORITY_OR_OTHER||ratio of geometric mean concentration|0.8|||||TWO_SIDED|95.0|0.63|1.0|||||Ratio of GMCs were calculated by back transformation of the mean difference between age groups on the logarithmic scale.|Serotype 3: To assess differences between reporting groups, 2-sided 95% CIs for the ratio of IgG GMCs were constructed by back transformation of the CIs for the mean difference of the log-transformed assay results computed using the Student t-distribution.||1.00|0.63|
72491783|NCT00562354|144511865|SUPERIORITY_OR_OTHER||ratio of geometric mean concentration|0.66|||||TWO_SIDED|95.0|0.48|0.91|||||Ratio of GMCs were calculated by back transformation of the mean difference between age groups on the logarithmic scale.|Serotype 4: To assess differences between reporting groups, 2-sided 95% CIs for the ratio of IgG GMCs were constructed by back transformation of the CIs for the mean difference of the log-transformed assay results computed using the Student t-distribution.||0.91|0.48|
72491784|NCT00562354|144511865|SUPERIORITY_OR_OTHER||ratio of geometric mean concentration|0.65|||||TWO_SIDED|95.0|0.5|0.85|||||Ratio of GMCs were calculated by back transformation of the mean difference between age groups on the logarithmic scale.|Serotype 5: To assess differences between reporting groups, 2-sided 95% CIs for the ratio of IgG GMCs were constructed by back transformation of the CIs for the mean difference of the log-transformed assay results computed using the Student t-distribution.||0.85|0.50|
72491785|NCT00562354|144511865|SUPERIORITY_OR_OTHER||ratio of geometric mean concentration|0.71|||||TWO_SIDED|95.0|0.52|0.97|||||Ratio of GMCs were calculated by back transformation of the mean difference between age groups on the logarithmic scale.|Serotype 6A: To assess differences between reporting groups, 2-sided 95% CIs for the ratio of IgG GMCs were constructed by back transformation of the CIs for the mean difference of the log-transformed assay results computed using the Student t-distribution.||0.97|0.52|
72517498|NCT00764478|144564744|SUPERIORITY_OR_OTHER_LEGACY||Least Square (LS) means difference|-3.5|STANDARD_ERROR_OF_MEAN|1.41||0.0136|TWO_SIDED|95.0|-6.3|-0.7||Adjusted p-value from graphical approach to control Type 1 error rate among primary and secondary hypotheses|MMRM||Asenapine 5 mg BID minus Placebo BID|||-0.7|-6.3|0.0136
72569338|NCT00444457|144669741|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|0.5|||||TWO_SIDED|95.0|-0.87|2.18|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Common serotypes - serotype 9V||2.18|-0.87|
72405088|NCT01336738|144317502|SUPERIORITY_OR_OTHER||LS Mean Difference|0.13|STANDARD_ERROR_OF_MEAN|0.413||0.7529|TWO_SIDED|95.0|-0.68|0.94||Two-sided p-value was calculated.|Mixed Models Analysis|||Week 12: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.94|-0.68|0.7529
72405089|NCT01336738|144317502|SUPERIORITY_OR_OTHER||LS Mean Difference|0.02|STANDARD_ERROR_OF_MEAN|0.411||0.9638|TWO_SIDED|95.0|-0.79|0.83||Two-sided p-value was calculated.|Mixed Models Analysis|||Week 12: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.83|-0.79|0.9638
72517499|NCT00764478|144564744|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-4.0|STANDARD_ERROR_OF_MEAN|1.43||0.01|TWO_SIDED|95.0|-6.9|-1.2||Adjusted p-value from graphical approach to control Type 1 error rate among primary and secondary hypotheses|MMRM||Asenapine 10 mg BID minus Placebo BID|||-1.2|-6.9|0.0100
72517500|NCT00764478|144564745|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.5|STANDARD_ERROR_OF_MEAN|0.16||0.01|TWO_SIDED|95.0|-0.8|-0.2||Adjusted p-value from Hochberg's method for testing two secondary efficacy hypotheses|MMRM||Asenapine 5 mg BID minus Placebo BID|||-0.2|-0.8|0.0100
72517501|NCT00764478|144564745|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.5|STANDARD_ERROR_OF_MEAN|0.16||0.0052|TWO_SIDED|95.0|-0.9|-0.2||Adjusted p-value from Hochberg's method for testing two secondary efficacy hypotheses|MMRM||Asenapine 10 mg BID minus Placebo BID|||-0.2|-0.9|0.0052
72517502|NCT00764478|144564746|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5352||||||Overall adjusted p-value from Hochberg's method for testing two secondary efficacy hypotheses|Cochran-Mantel-Haenszel|||||||0.5352
72517503|NCT00764478|144564746|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4274||||||Overall adjusted p-value from Hochberg's method for testing two secondary efficacy hypotheses|Cochran-Mantel-Haenszel|||||||0.4274
72517504|NCT00764478|144564747|SUPERIORITY_OR_OTHER_LEGACY||Least Square (LS) means difference|-2.7|STANDARD_ERROR_OF_MEAN|0.78||0.0007|TWO_SIDED|95.0|-4.2|-1.1|||MMRM||Asenapine 5 mg BID minus Placebo BID|Day 2||-1.1|-4.2|0.0007
72517505|NCT00764478|144564747|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-2.9|STANDARD_ERROR_OF_MEAN|0.79||0.0003|TWO_SIDED|95.0|-4.4|-1.3|||MMRM||Asenapine 10 mg BID minus Placebo BID|Day 2||-1.3|-4.4|0.0003
72517506|NCT00764478|144564747|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-3.6|STANDARD_ERROR_OF_MEAN|0.91|<|0.0001|TWO_SIDED|95.0|-5.4|-1.8|||MMRM||Asenapine 5 mg BID minus Placebo BID|Day 4||-1.8|-5.4|<0.0001
72517507|NCT00764478|144564747|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-3.7|STANDARD_ERROR_OF_MEAN|0.92|<|0.0001|TWO_SIDED|95.0|-5.5|-1.9|||MMRM||Asenapine 10 mg BID minus Placebo BID|Day 4||-1.9|-5.5|<0.0001
72517508|NCT00764478|144564747|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-3.5|STANDARD_ERROR_OF_MEAN|1.12||0.0021|TWO_SIDED|95.0|-5.7|-1.3|||MMRM||Asenapine 5 mg BID minus Placebo BID|Day 7||-1.3|-5.7|0.0021
72517509|NCT00764478|144564747|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-4.2|STANDARD_ERROR_OF_MEAN|1.13||0.0002|TWO_SIDED|95.0|-6.4|-2.0|||MMRM||Asenapine 10 mg BID minus Placebo BID|Day 7||-2.0|-6.4|0.0002
72405090|NCT01336738|144317502|SUPERIORITY_OR_OTHER||LS Mean Difference|0.67|STANDARD_ERROR_OF_MEAN|0.404||0.0962|TWO_SIDED|95.0|-0.12|1.47||Two-sided p-value was calculated.|Mixed Models Analysis|||Week 12: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||1.47|-0.12|0.0962
72491786|NCT00562354|144511865|SUPERIORITY_OR_OTHER||ratio of geometric mean concentration|0.65|||||TWO_SIDED|95.0|0.48|0.9|||||Ratio of GMCs were calculated by back transformation of the mean difference between age groups on the logarithmic scale.|Serotype 6B: To assess differences between reporting groups, 2-sided 95% CIs for the ratio of IgG GMCs were constructed by back transformation of the CIs for the mean difference of the log-transformed assay results computed using the Student t-distribution.||0.90|0.48|
72517510|NCT00764478|144564747|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-1.8|STANDARD_ERROR_OF_MEAN|1.35||0.1907|TWO_SIDED|95.0|-4.4|0.9|||MMRM||Asenapine 5 mg BID minus Placebo BID|Day 14||0.9|-4.4|0.1907
72517511|NCT00764478|144564747|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-3.1|STANDARD_ERROR_OF_MEAN|1.37||0.0238|TWO_SIDED|95.0|-5.8|-0.4|||MMRM||Asenapine 10 mg BID minus Placebo BID|Day 14||-0.4|-5.8|0.0238
72517512|NCT00764478|144564748|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2922|||||||Cochran-Mantel-Haenszel|||Day 2||||0.2922
72517513|NCT00764478|144564748|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1001|||||||Cochran-Mantel-Haenszel|||Day 2||||0.1001
72517514|NCT00764478|144564748|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0011|||||||Cochran-Mantel-Haenszel|||Day 4||||0.0011
72517515|NCT00764478|144564748|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0011|||||||Cochran-Mantel-Haenszel|||Day 4||||0.0011
72517516|NCT00764478|144564748|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0194|||||||Cochran-Mantel-Haenszel|||Day 7||||0.0194
72517517|NCT00764478|144564748|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0841|||||||Cochran-Mantel-Haenszel|||Day 7||||0.0841
72517518|NCT00764478|144564748|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4858|||||||Cochran-Mantel-Haenszel|||Day 14||||0.4858
72517519|NCT00764478|144564748|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2496|||||||Cochran-Mantel-Haenszel|||Day 14||||0.2496
72517520|NCT00764478|144564749|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2912|||||||Cochran-Mantel-Haenszel|||||||0.2912
72569339|NCT00444457|144669741|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|0.3|||||TWO_SIDED|95.0|-0.74|1.62|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Common serotypes - serotype 14||1.62|-0.74|
72569340|NCT00444457|144669741|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|0.0|||||TWO_SIDED|95.0|-1.03|1.04|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Common serotypes - serotype 14||1.04|-1.03|
72405091|NCT02970968|144317506|SUPERIORITY|||||||0.0099|||||||Mixed Models Analysis|||||||.0099
72405092|NCT02970968|144317507|SUPERIORITY|||||||0.016|||||||Mixed Models Analysis|||||||.0160
72405093|NCT02970968|144317508|SUPERIORITY|||||||0.039|||||||Mixed Models Analysis|||||||.039
72405094|NCT02970968|144317509|SUPERIORITY|||||||0.0223|||||||Mixed Models Analysis|||||||.0223
72405095|NCT02970968|144317510|SUPERIORITY|||||||0.0497|||||||Mixed Models Analysis|||||||.0497
72405096|NCT02970968|144317511|SUPERIORITY|||||||0.0207|||||||Mixed Models Analysis|||||||.0207
72569341|NCT00444457|144669741|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|-0.3|||||TWO_SIDED|95.0|-1.61|0.76|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Common serotypes - serotype 14||0.76|-1.61|
72569342|NCT00444457|144669741|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|0.4|||||TWO_SIDED|95.0|-1.52|2.39|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Common serotypes - serotype 18C||2.39|-1.52|
72569343|NCT00444457|144669741|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|-0.5|||||TWO_SIDED|95.0|-2.3|1.04|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Common serotypes - serotype 18C||1.04|-2.30|
72569344|NCT00444457|144669741|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|-0.9|||||TWO_SIDED|95.0|-2.87|0.74|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Common serotypes - serotype 18C||0.74|-2.87|
72569345|NCT00444457|144669741|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|-0.5|||||TWO_SIDED|95.0|-2.55|1.5|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Common serotypes - serotype 19F||1.50|-2.55|
72569346|NCT00444457|144669741|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|-1.1|||||TWO_SIDED|95.0|-3.06|0.57|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Common serotypes - serotype 19F||0.57|-3.06|
72569347|NCT00444457|144669741|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|-0.6|||||TWO_SIDED|95.0|-2.44|1.0|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Common serotypes - serotype 19F||1.00|-2.44|
72405097|NCT02970968|144317512|SUPERIORITY|||||||0.0429|||||||Mixed Models Analysis|||||||.0429
72569348|NCT00444457|144669741|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|0.3|||||TWO_SIDED|95.0|-1.21|2.05|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Common serotypes - serotype 23F||2.05|-1.21|
72569349|NCT00444457|144669741|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|1.1|||||TWO_SIDED|95.0|-0.52|3.16|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Common serotypes - serotype 23F||3.16|-0.52|
72569350|NCT00444457|144669741|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|0.8|||||TWO_SIDED|95.0|-1.05|2.87|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Common serotypes - serotype 23F||2.87|-1.05|
72569351|NCT00444457|144669741|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|0.9|||||TWO_SIDED|95.0|-0.17|2.53|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Additional serotypes - serotype 1||2.53|-0.17|
72405098|NCT02970968|144317513|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||||||<.0001
72405099|NCT02970968|144317514|SUPERIORITY|||||||0.0003|||||||Mixed Models Analysis|||||||.0003
72405100|NCT02970968|144317515|SUPERIORITY|||||||0.023|||||||Mixed Models Analysis|||||||.023
72405101|NCT02970968|144317516|SUPERIORITY|||||||0.0078|||||||Mixed Models Analysis|||||||.0078
72405102|NCT02970968|144317517|SUPERIORITY|||||||0.0294|||||||Mixed Models Analysis|||||||.0294
72405103|NCT02970968|144317518|SUPERIORITY|||||||0.0229|||||||Mixed Models Analysis|||||||.0229
72405104|NCT02970968|144317519|SUPERIORITY|||||||0.0018|||||||Mixed Models Analysis|||||||.0018
72405105|NCT02970968|144317520|SUPERIORITY|||||||0.0013|||||||Mixed Models Analysis|||||||.0013
72405106|NCT02970968|144317521|SUPERIORITY|||||||0.0001|||||||Mixed Models Analysis|||||||.0001
72405107|NCT02970968|144317522|SUPERIORITY|||||||0.018|||||||Mixed Models Analysis|||||||.018
72405108|NCT02970968|144317523|SUPERIORITY|||||||0.0164|||||||Mixed Models Analysis|||||||.0164
72405109|NCT02970968|144317524|SUPERIORITY|||||||0.0053|||||||Mixed Models Analysis|||||||.0053
72405110|NCT02970968|144317525|SUPERIORITY|||||||0.002|||||||Mixed Models Analysis|||||||.0020
72491787|NCT00562354|144511865|SUPERIORITY_OR_OTHER||ratio of geometric mean concentration|0.74|||||TWO_SIDED|95.0|0.56|0.97|||||Ratio of GMCs were calculated by back transformation of the mean difference between age groups on the logarithmic scale.|Serotype 7F: To assess differences between reporting groups, 2-sided 95% CIs for the ratio of IgG GMCs were constructed by back transformation of the CIs for the mean difference of the log-transformed assay results computed using the Student t-distribution.||0.97|0.56|
72624782|NCT01346592|144778966|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (H3N2 strain)|2.07|||||TWO_SIDED|95.0|1.75|2.45||||||No risk subjects||2.45|1.75|
72405111|NCT03240575|144317572|SUPERIORITY||Mean Difference (Net)|0.052|STANDARD_ERROR_OF_MEAN|0.027||0.0543|TWO_SIDED|95.0|-0.001|0.105|||Mixed-effects model repeated measures|Treatment, visit and treatment by visit interaction as fixed effects, and baseline as well as baseline by visit interaction as covariates.||||0.105|-0.001|0.0543
72491788|NCT00562354|144511865|SUPERIORITY_OR_OTHER||ratio of geometric mean concentration|0.46|||||TWO_SIDED|95.0|0.35|0.61|||||Ratio of GMCs were calculated by back transformation of the mean difference between age groups on the logarithmic scale.|Serotype 9V: To assess differences between reporting groups, 2-sided 95% CIs for the ratio of IgG GMCs were constructed by back transformation of the CIs for the mean difference of the log-transformed assay results computed using the Student t-distribution.||0.61|0.35|
72491789|NCT00562354|144511865|SUPERIORITY_OR_OTHER||ratio of geometric mean concentration|0.76|||||TWO_SIDED|95.0|0.56|1.03|||||Ratio of GMCs were calculated by back transformation of the mean difference between age groups on the logarithmic scale.|Serotype 14: To assess differences between reporting groups, 2-sided 95% CIs for the ratio of IgG GMCs were constructed by back transformation of the CIs for the mean difference of the log-transformed assay results computed using the Student t-distribution.||1.03|0.56|
72491790|NCT00562354|144511865|SUPERIORITY_OR_OTHER||ratio of geometric mean concentration|0.57|||||TWO_SIDED|95.0|0.43|0.74|||||Ratio of GMCs were calculated by back transformation of the mean difference between age groups on the logarithmic scale.|Serotype 18C: To assess differences between reporting groups, 2-sided 95% CIs for the ratio of IgG GMCs were constructed by back transformation of the CIs for the mean difference of the log-transformed assay results computed using the Student t-distribution.||0.74|0.43|
72491791|NCT00562354|144511865|SUPERIORITY_OR_OTHER||ratio of geometric mean concentration|0.5|||||TWO_SIDED|95.0|0.38|0.66|||||Ratio of GMCs were calculated by back transformation of the mean difference between age groups on the logarithmic scale.|Serotype 19A: To assess differences between reporting groups, 2-sided 95% CIs for the ratio of IgG GMCs were constructed by back transformation of the CIs for the mean difference of the log-transformed assay results computed using the Student t-distribution.||0.66|0.38|
72491792|NCT00562354|144511865|SUPERIORITY_OR_OTHER||ratio of geometric mean concentration|0.42|||||TWO_SIDED|95.0|0.29|0.6|||||Ratio of GMCs were calculated by back transformation of the mean difference between age groups on the logarithmic scale.|Serotype 19F: To assess differences between reporting groups, 2-sided 95% CIs for the ratio of IgG GMCs were constructed by back transformation of the CIs for the mean difference of the log-transformed assay results computed using the Student t-distribution.||0.60|0.29|
72491793|NCT00562354|144511865|SUPERIORITY_OR_OTHER||ratio of geometric mean concentration|0.59|||||TWO_SIDED|95.0|0.42|0.82|||||Ratio of GMCs were calculated by back transformation of the mean difference between age groups on the logarithmic scale.|Serotype 23F: To assess differences between reporting groups, 2-sided 95% CIs for the ratio of IgG GMCs were constructed by back transformation of the CIs for the mean difference of the log-transformed assay results computed using the Student t-distribution.||0.82|0.42|
72491794|NCT01883635|144511889|SUPERIORITY_OR_OTHER|||||||0.14|TWO_SIDED||||||t-test, 2 sided|degrees of freedom=40||||||0.14
72491795|NCT01883635|144511890|SUPERIORITY_OR_OTHER|||||||0.65|TWO_SIDED||||||t-test, 2 sided|degrees of freedom=40||||||0.65
72491796|NCT01883635|144511891|SUPERIORITY_OR_OTHER|||||||0.51|TWO_SIDED||||||t-test, 2 sided|degrees of freedom=40||||||0.51
72491797|NCT01187953|144511892|NON_INFERIORITY_OR_EQUIVALENCE|It was assumed that both treatment groups in this study would have a 15% 12-month treatment failure rate, the study will require 270 patients per group to have 90% power to reject the null hypothesis that the investigational drug, LCP-tacro, is inferior to the reference drug, Prograf, based on a 2-sided 95% CI for the difference and a 0.10 non-inferiority margin.|||||>|0.999|TWO_SIDED|||||Endpoint: Death|Fisher Exact|||No overall p value was calculated, only individual p values for each endpoint category. One statistical analysis table is reported for each individual p value.||||>0.999
72517521|NCT00764478|144564749|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1151|||||||Cochran-Mantel-Haenszel|||||||0.1151
72405112|NCT03240575|144317573|SUPERIORITY||Mean Difference (Net)|0.09|STANDARD_ERROR_OF_MEAN|0.027||0.0011|TWO_SIDED|95.0|0.037|0.144|||Mixed-effects model repeated measures|Treatment, visit and treatment by visit interaction as fixed effects, and baseline as well as baseline by visit interaction as covariates.||||0.144|0.037|0.0011
72517522|NCT00764478|144564751|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0019|||||||ANCOVA|||Day 7||||0.0019
72517523|NCT00764478|144564751|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0045|||||||ANCOVA|||Day 7||||0.0045
72517524|NCT00764478|144564751|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0112|||||||ANCOVA|||Day 21||||0.0112
72517525|NCT00764478|144564751|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0021|||||||ANCOVA|||Day 21||||0.0021
72517526|NCT00764478|144564752|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.3|STANDARD_ERROR_OF_MEAN|0.07|<|0.0001|TWO_SIDED|95.0|-0.4|-0.1|||MMRM||Asenapine 5 mg BID minus Placebo BID|Day 2||-0.1|-0.4|<0.0001
72517527|NCT00764478|144564752|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.2|STANDARD_ERROR_OF_MEAN|0.07||0.0076|TWO_SIDED|95.0|-0.3|-0.1|||MMRM||Asenapine 10 mg BID minus Placebo BID|Day 2||-0.1|-0.3|0.0076
72517528|NCT00764478|144564752|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.4|STANDARD_ERROR_OF_MEAN|0.1||0.0004|TWO_SIDED|95.0|-0.6|-0.2|||MMRM||Asenapine 5 mg BID minus Placebo BID|Day 4||-0.2|-0.6|0.0004
72517529|NCT00764478|144564752|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.3|STANDARD_ERROR_OF_MEAN|0.1||0.004|TWO_SIDED|95.0|-0.5|-0.1|||MMRM||Asenapine 10 mg BID minus Placebo BID|Day 4||-0.1|-0.5|0.0040
72517530|NCT00764478|144564752|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.3|STANDARD_ERROR_OF_MEAN|0.12||0.0061|TWO_SIDED|95.0|-0.6|-0.1|||MMRM||Asenapine 5 mg BID minus Placebo BID|Day 7||-0.1|-0.6|0.0061
72517531|NCT00764478|144564752|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.4|STANDARD_ERROR_OF_MEAN|0.13||0.0031|TWO_SIDED|95.0|-0.6|-0.1|||MMRM||Asenapine 10 mg BID minus Placebo BID|Day 7||-0.1|-0.6|0.0031
72517532|NCT00764478|144564752|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.2|STANDARD_ERROR_OF_MEAN|0.14||0.1086|TWO_SIDED|95.0|-0.5|0.1|||MMRM||Asenapine 5 mg BID minus Placebo BID|Day 14||0.1|-0.5|0.1086
72517533|NCT00764478|144564752|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.3|STANDARD_ERROR_OF_MEAN|0.15||0.0376|TWO_SIDED|95.0|-0.6|0.0|||MMRM||Asenapine 10 mg BID minus Placebo BID|Day 14||-0.0|-0.6|0.0376
72517534|NCT00764478|144564753|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0005|||||||ANCOVA|||Day 2||||0.0005
72517535|NCT00764478|144564753|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0026|||||||ANCOVA|||Day 2||||0.0026
72517536|NCT00764478|144564753|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0007|||||||ANCOVA|||Day 4||||0.0007
72517537|NCT00764478|144564753|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0002|||||||ANCOVA|||Day 4||||0.0002
72517538|NCT00764478|144564753|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0387|||||||ANCOVA|||Day 7||||0.0387
72517539|NCT00764478|144564753|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0059|||||||ANCOVA|||Day 7||||0.0059
72517540|NCT00764478|144564753|SUPERIORITY_OR_OTHER_LEGACY|||||||0.311|||||||ANCOVA|||Day 14||||0.3110
72517541|NCT00764478|144564753|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0613|||||||ANCOVA|||Day 14||||0.0613
72517542|NCT00764478|144564753|SUPERIORITY_OR_OTHER_LEGACY|||||||0.064|||||||ANCOVA|||Day 21||||0.0640
72517543|NCT00764478|144564753|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0139|||||||ANCOVA|||Day 21||||0.0139
72517544|NCT00764478|144564754|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9708|||||||ANCOVA|||Day 2||||0.9708
72517545|NCT00764478|144564754|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7891|||||||ANCOVA|||Day 2||||0.7891
72517546|NCT00764478|144564754|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5222|||||||ANCOVA|||Day 4||||0.5222
72491798|NCT01187953|144511892|NON_INFERIORITY_OR_EQUIVALENCE|It was assumed that both treatment groups in this study would have a 15% 12-month treatment failure rate, the study will require 270 patients per group to have 90% power to reject the null hypothesis that the investigational drug, LCP-tacro, is inferior to the reference drug, Prograf, based on a 2-sided 95% CI for the difference and a 0.10 non-inferiority margin.||||||0.821|TWO_SIDED|||||Endpoint: Graft Failure|Fisher Exact|||No overall p value was calculated, only individual p values for each endpoint category. One statistical analysis table is reported for each individual p value.||||0.821
72517547|NCT00764478|144564754|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8686|||||||ANCOVA|||Day 4||||0.8686
72491799|NCT01187953|144511892|NON_INFERIORITY_OR_EQUIVALENCE|It was assumed that both treatment groups in this study would have a 15% 12-month treatment failure rate, the study will require 270 patients per group to have 90% power to reject the null hypothesis that the investigational drug, LCP-tacro, is inferior to the reference drug, Prograf, based on a 2-sided 95% CI for the difference and a 0.10 non-inferiority margin.||||||0.9|TWO_SIDED|||||Endpoint: BPAR|Fisher Exact|||No overall p value was calculated, only individual p values for each endpoint category. One statistical analysis table is reported for each individual p value.||||0.900
72491800|NCT01187953|144511892|NON_INFERIORITY_OR_EQUIVALENCE|It was assumed that both treatment groups in this study would have a 15% 12-month treatment failure rate, the study will require 270 patients per group to have 90% power to reject the null hypothesis that the investigational drug, LCP-tacro, is inferior to the reference drug, Prograf, based on a 2-sided 95% CI for the difference and a 0.10 non-inferiority margin.|||||>|0.999|TWO_SIDED|||||Endpoint: Lost to follow up|Fisher Exact|||No overall p value was calculated, only individual p values for each endpoint category. One statistical analysis table is reported for each individual p value.||||>0.999
72517548|NCT00764478|144564754|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0696|||||||ANCOVA|||Day 7||||0.0696
72517549|NCT00764478|144564754|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0049|||||||ANCOVA|||Day 7||||0.0049
72517550|NCT00764478|144564754|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0196|||||||ANCOVA|||Day 14||||0.0196
72517551|NCT00764478|144564754|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0032|||||||ANCOVA|||Day 14||||0.0032
72517552|NCT00764478|144564754|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0061|||||||ANCOVA|||Day 21||||0.0061
72517553|NCT00764478|144564754|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0012|||||||ANCOVA|||Day 21||||0.0012
72517554|NCT00764478|144564755|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0147|||||||Cochran-Mantel-Haenszel|||Day 2||||0.0147
72517555|NCT00764478|144564755|SUPERIORITY_OR_OTHER_LEGACY|||||||0.072|||||||Cochran-Mantel-Haenszel|||Day 2||||0.0720
72517556|NCT00764478|144564755|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1213|||||||Cochran-Mantel-Haenszel|||Day 4||||0.1213
72517557|NCT00764478|144564755|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0588|||||||Cochran-Mantel-Haenszel|||Day 4||||0.0588
72405113|NCT03240575|144317574|SUPERIORITY||Mean Difference (Net)|0.005|STANDARD_ERROR_OF_MEAN|0.027||0.8593|TWO_SIDED|95.0|-0.048|0.058|||Mixed-effects model repeated measures|Treatment, visit and treatment by visit interaction as fixed effects, and baseline as well as baseline by visit interaction as covariates.||||0.058|-0.048|0.8593
72517558|NCT00764478|144564755|SUPERIORITY_OR_OTHER_LEGACY|||||||0.02|||||||Cochran-Mantel-Haenszel|||Day 7||||0.0200
72517559|NCT00764478|144564755|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0017|||||||Cochran-Mantel-Haenszel|||Day 7||||0.0017
72517560|NCT00764478|144564755|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2401|||||||Cochran-Mantel-Haenszel|||Day 14||||0.2401
72517561|NCT00764478|144564755|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0009|||||||Cochran-Mantel-Haenszel|||Day 14||||0.0009
72517562|NCT00764478|144564755|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0525|||||||Cochran-Mantel-Haenszel|||Day 21||||0.0525
72517563|NCT00764478|144564755|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0025|||||||Cochran-Mantel-Haenszel|||Day 21||||0.0025
72517564|NCT00764478|144564756|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0377|||||||Cochran-Mantel-Haenszel|||Day 2||||0.0377
72517565|NCT00764478|144564756|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0771|||||||Cochran-Mantel-Haenszel|||Day 2||||0.0771
72517566|NCT00764478|144564756|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1264|||||||Cochran-Mantel-Haenszel|||Day 4||||0.1264
72517567|NCT00764478|144564756|SUPERIORITY_OR_OTHER_LEGACY|||||||0.028|||||||Cochran-Mantel-Haenszel|||Day 4||||0.0280
72517568|NCT00764478|144564756|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0583|||||||Cochran-Mantel-Haenszel|||Day 7||||0.0583
72517569|NCT00764478|144564756|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0021|||||||Cochran-Mantel-Haenszel|||Day 7||||0.0021
72517570|NCT00764478|144564756|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0866|||||||Cochran-Mantel-Haenszel|||Day 14||||0.0866
72517571|NCT00764478|144564756|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0048|||||||Cochran-Mantel-Haenszel|||Day 14||||0.0048
72517572|NCT00764478|144564756|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0147|||||||Cochran-Mantel-Haenszel|||Day 21||||0.0147
72517573|NCT00764478|144564756|SUPERIORITY_OR_OTHER_LEGACY|||||||0.003|||||||Cochran-Mantel-Haenszel|||Day 21||||0.0030
72517574|NCT00764478|144564757|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0104|||||||Cochran-Mantel-Haenszel|||Day 2||||0.0104
72517575|NCT00764478|144564757|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0005|||||||Cochran-Mantel-Haenszel|||Day 2||||0.0005
72517576|NCT00764478|144564757|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0692|||||||Cochran-Mantel-Haenszel|||Day 4||||0.0692
72517577|NCT00764478|144564757|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0128|||||||Cochran-Mantel-Haenszel|||Day 4||||0.0128
72405114|NCT03240575|144317575|SUPERIORITY||Mean Difference (Net)|0.098|STANDARD_ERROR_OF_MEAN|0.029||0.001|TWO_SIDED|95.0|0.04|0.156|||Mixed-effects model repeated measures|Treatment, visit and treatment by visit interaction as fixed effects, and baseline as well as baseline by visit interaction as covariates.||||0.156|0.040|0.0010
72491801|NCT01187953|144511893|NON_INFERIORITY_OR_EQUIVALENCE|It was assumed that both treatment groups in this study would have a 15% 12-month treatment failure rate, the study will require 270 patients per group to have 90% power to reject the null hypothesis that the investigational drug, LCP-tacro, is inferior to the reference drug, Prograf, based on a 2-sided 95% CI for the difference and a 0.10 non-inferiority margin.||||||0.835|TWO_SIDED|||||Endpoint: Death|Fisher Exact|||No overall p value was calculated, only individual p values for each endpoint category. One statistical analysis table is reported for each individual p value.||||0.835
72517578|NCT00764478|144564757|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0809|||||||Cochran-Mantel-Haenszel|||Day 7||||0.0809
72517579|NCT00764478|144564757|SUPERIORITY_OR_OTHER_LEGACY|||||||0.026|||||||Cochran-Mantel-Haenszel|||Day 7||||0.0260
72517580|NCT00764478|144564757|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2576|||||||Cochran-Mantel-Haenszel|||Day 14||||0.2576
72517581|NCT00764478|144564757|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0077|||||||Cochran-Mantel-Haenszel|||Day 14||||0.0077
72517582|NCT00764478|144564757|SUPERIORITY_OR_OTHER_LEGACY|||||||0.396|||||||Cochran-Mantel-Haenszel|||Day 21||||0.3960
72517583|NCT00764478|144564757|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0141|||||||Cochran-Mantel-Haenszel|||Day 21||||0.0141
72517584|NCT00764478|144564758|SUPERIORITY_OR_OTHER_LEGACY||Least Square (LS) means difference|-3.0|STANDARD_ERROR_OF_MEAN|1.06||0.0056|TWO_SIDED|95.0|-5.1|-0.9|||MMRM||Asenapine 5 mg BID minus Placebo BID|Day 7||-0.9|-5.1|0.0056
72405115|NCT00913744|144317587|SUPERIORITY_OR_OTHER||Difference in proportions|12.3||||0.262|TWO_SIDED|95.0|-3.7|28.4|||Fisher Exact|P-value is from Fisher's exact test, comparing sham and ocriplasmin.||||28.4|-3.7|0.262
72491802|NCT01187953|144511893|NON_INFERIORITY_OR_EQUIVALENCE|It was assumed that both treatment groups in this study would have a 15% 12-month treatment failure rate, the study will require 270 patients per group to have 90% power to reject the null hypothesis that the investigational drug, LCP-tacro, is inferior to the reference drug, Prograf, based on a 2-sided 95% CI for the difference and a 0.10 non-inferiority margin.||||||0.548|TWO_SIDED|||||Endpoint: Graft Failure|Fisher Exact|||No overall p value was calculated, only individual p values for each endpoint category. One statistical analysis table is reported for each individual p value.||||0.548
72491803|NCT01187953|144511893|NON_INFERIORITY_OR_EQUIVALENCE|It was assumed that both treatment groups in this study would have a 15% 12-month treatment failure rate, the study will require 270 patients per group to have 90% power to reject the null hypothesis that the investigational drug, LCP-tacro, is inferior to the reference drug, Prograf, based on a 2-sided 95% CI for the difference and a 0.10 non-inferiority margin.||||||0.822|TWO_SIDED|||||Endpoint: BPAR|Fisher Exact|||No overall p value was calculated, only individual p values for each endpoint category. One statistical analysis table is reported for each individual p value.||||0.822
72491804|NCT01187953|144511893|NON_INFERIORITY_OR_EQUIVALENCE|It was assumed that both treatment groups in this study would have a 15% 12-month treatment failure rate, the study will require 270 patients per group to have 90% power to reject the null hypothesis that the investigational drug, LCP-tacro, is inferior to the reference drug, Prograf, based on a 2-sided 95% CI for the difference and a 0.10 non-inferiority margin.||||||0.383|TWO_SIDED|||||Endpoint: Lost to follow up|Fisher Exact|||No overall p value was calculated, only individual p values for each endpoint category. One statistical analysis table is reported for each individual p value.||||0.383
72491805|NCT01464307|144511894|SUPERIORITY_OR_OTHER||Least Square Mean Difference|0.0||||0.777|TWO_SIDED|95.0|-0.1|0.2|||Mixed-Model Repeated Measures|||The number of subjects included in the MMRM analysis was only 286 because a covariate was missing for 3 subjects.||0.2|-0.1|0.777
72491806|NCT01464307|144511895|SUPERIORITY_OR_OTHER|||||||0.804||||||worst-case analysis.|Wilcoxon's Rank-Sum Test|||The statistical analysis provided was for all categories of this outcome measure.||||0.804
72491807|NCT01464307|144511896|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.05||||0.845|TWO_SIDED|95.0|0.63|1.74||observed cases analysis.|Regression, Logistic|||Week 4. Number of subjects included in analysis was three less than the observed cases because of a missing covariate for the logistic regression analysis, that is, n=283 for week 4.||1.74|0.63|0.845
72517585|NCT00764478|144564758|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-2.9|STANDARD_ERROR_OF_MEAN|1.08||0.0068|TWO_SIDED|95.0|-5.0|-0.8|||MMRM||Asenapine 10 mg BID minus Placebo BID|Day 7||-0.8|-5.0|0.0068
72517586|NCT00764478|144564758|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-2.4|STANDARD_ERROR_OF_MEAN|1.33||0.0743|TWO_SIDED|95.0|-5.0|0.2|||MMRM||Asenapine 5 mg BID minus Placebo BID|Day 14||0.2|-5.0|0.0743
72517587|NCT00764478|144564758|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-3.2|STANDARD_ERROR_OF_MEAN|1.35||0.0177|TWO_SIDED|95.0|-5.9|-0.6|||MMRM||Asenapine 10 mg BID minus Placebo BID|Day 14||-0.6|-5.9|0.0177
72517588|NCT00764478|144564758|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-3.8|STANDARD_ERROR_OF_MEAN|1.41||0.0081|TWO_SIDED|95.0|-6.6|-1.0|||MMRM||Asenapine 5 mg BID minus Placebo BID|Day 21||-1.0|-6.6|0.0081
72517589|NCT00764478|144564758|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-3.2|STANDARD_ERROR_OF_MEAN|1.43||0.0247|TWO_SIDED|95.0|-6.1|-0.4|||MMRM||Asenapine 10 mg BID minus Placebo BID|Day 21||-0.4|-6.1|0.0247
72517590|NCT00764478|144564759|SUPERIORITY_OR_OTHER_LEGACY||Least Square (LS) means difference|0.0|STANDARD_ERROR_OF_MEAN|0.3||0.9808|TWO_SIDED|95.0|-0.6|0.6|||MMRM||Asenapine 5 mg BID minus Placebo BID|Day 7||0.6|-0.6|0.9808
72517591|NCT00764478|144564759|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.3|STANDARD_ERROR_OF_MEAN|0.31||0.283|TWO_SIDED|95.0|-0.9|0.3|||MMRM||Asenapine 10 mg BID minus Placebo BID|Day 7||0.3|-0.9|0.2830
72517592|NCT00764478|144564759|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.0|STANDARD_ERROR_OF_MEAN|0.32||0.9751|TWO_SIDED|95.0|-0.6|0.6|||MMRM||Asenapine 5 mg BID minus Placebo BID|Day 14||0.6|-0.6|0.9751
72517593|NCT00764478|144564759|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.1|STANDARD_ERROR_OF_MEAN|0.33||0.7879|TWO_SIDED|95.0|-0.6|0.7|||MMRM||Asenapine 10 mg BID minus Placebo BID|Day 14||0.7|-0.6|0.7879
72517594|NCT00764478|144564759|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.0|STANDARD_ERROR_OF_MEAN|0.38||0.9654|TWO_SIDED|95.0|-0.8|0.7|||MMRM||Asenapine 5 mg BID minus Placebo BID|Day 21||0.7|-0.8|0.9654
72517595|NCT00764478|144564759|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.3|STANDARD_ERROR_OF_MEAN|0.39||0.3917|TWO_SIDED|95.0|-0.4|1.1|||MMRM||Asenapine 10 mg BID minus Placebo BID|Day 21||1.1|-0.4|0.3917
72517596|NCT00764478|144564760|SUPERIORITY_OR_OTHER_LEGACY||Least Square (LS) means difference|-1.0|STANDARD_ERROR_OF_MEAN|0.41||0.012|TWO_SIDED|95.0|-1.8|-0.2|||MMRM||Asenapine 5 mg BID minus Placebo BID|Day 7||-0.2|-1.8|0.0120
72517597|NCT00764478|144564760|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-1.4|STANDARD_ERROR_OF_MEAN|0.42||0.0011|TWO_SIDED|95.0|-2.2|-0.5|||MMRM||Asenapine 10 mg BID minus Placebo BID|Day 7||-0.5|-2.2|0.0011
72517598|NCT00764478|144564760|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.2|STANDARD_ERROR_OF_MEAN|0.51||0.6885|TWO_SIDED|95.0|-1.2|0.8|||MMRM||Asenapine 5 mg BID minus Placebo BID|Day 14||0.8|-1.2|0.6885
72517599|NCT00764478|144564760|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-1.1|STANDARD_ERROR_OF_MEAN|0.52||0.0398|TWO_SIDED|95.0|-2.1|-0.1|||MMRM||Asenapine 10 mg BID minus Placebo BID|Day 14||-0.1|-2.1|0.0398
72517600|NCT00764478|144564760|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-1.1|STANDARD_ERROR_OF_MEAN|0.51||0.0258|TWO_SIDED|95.0|-2.1|-0.1|||MMRM||Asenapine 5 mg BID minus Placebo BID|Day 21||-0.1|-2.1|0.0258
72517601|NCT00764478|144564760|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-1.5|STANDARD_ERROR_OF_MEAN|0.51||0.0031|TWO_SIDED|95.0|-2.5|-0.5|||MMRM||Asenapine 10 mg BID minus Placebo BID|Day 21||-0.5|-2.5|0.0031
72517602|NCT00764478|144564761|SUPERIORITY_OR_OTHER_LEGACY||Least Square (LS) means difference|-1.9|STANDARD_ERROR_OF_MEAN|0.64||0.0033|TWO_SIDED|95.0|-3.2|-0.6|||MMRM||Asenapine 5 mg BID minus Placebo BID|Day 7||-0.6|-3.2|0.0033
72517603|NCT00764478|144564761|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-1.2|STANDARD_ERROR_OF_MEAN|0.65||0.0622|TWO_SIDED|95.0|-2.5|0.1|||MMRM||Asenapine 10 mg BID minus Placebo BID|Day 7||0.1|-2.5|0.0622
72517604|NCT00764478|144564761|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-2.1|STANDARD_ERROR_OF_MEAN|0.79||0.0083|TWO_SIDED|95.0|-3.6|-0.5|||MMRM||Asenapine 5 mg BID minus Placebo BID|Day 14||-0.5|-3.6|0.0083
72491808|NCT01464307|144511896|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.23||||0.437|TWO_SIDED|95.0|0.73|2.04||observed cases analysis.|Regression, Logistic|||Week 8. Number of subjects included in analysis was three less than the observed cases because of a missing covariate for the logistic regression analysis, that is, n=279 for week 8.||2.04|0.73|0.437
72491809|NCT01464307|144511896|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.14||||0.698|TWO_SIDED|95.0|0.59|2.21||observed cases analysis.|Regression, Logistic|||Week 12. Number of subjects included in analysis was three less than the observed cases because of a missing covariate for the logistic regression analysis, that is, n=273 for week 12.||2.21|0.59|0.698
72491810|NCT00802204|144511921|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|describe.....||Baseline outcome measurements are compared between lean and obese. Baseline and post outcome measurements are compared for the obese who completed VLCD||||<0.05
72517605|NCT00764478|144564761|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-2.2|STANDARD_ERROR_OF_MEAN|0.8||0.0064|TWO_SIDED|95.0|-3.8|-0.6|||MMRM||Asenapine 10 mg BID minus Placebo BID|Day 14||-0.6|-3.8|0.0064
72517606|NCT00764478|144564761|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-2.6|STANDARD_ERROR_OF_MEAN|0.84||0.0022|TWO_SIDED|95.0|-4.3|-0.9|||MMRM||Asenapine 5 mg BID minus Placebo BID|Day 21||-0.9|-4.3|0.0022
72517607|NCT00764478|144564761|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-2.0|STANDARD_ERROR_OF_MEAN|0.85||0.0196|TWO_SIDED|95.0|-3.7|-0.3|||MMRM||Asenapine 10 mg BID minus Placebo BID|Day 21||-0.3|-3.7|0.0196
72517608|NCT00764478|144564762|SUPERIORITY_OR_OTHER_LEGACY||Least Square (LS) means difference|-0.5|STANDARD_ERROR_OF_MEAN|0.4||0.1883|TWO_SIDED|95.0|-1.3|0.3|||MMRM||Asenapine 5 mg BID minus Placebo BID|Day 7||0.3|-1.3|0.1883
72517609|NCT00764478|144564762|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.6|STANDARD_ERROR_OF_MEAN|0.4||0.1684|TWO_SIDED|95.0|-1.3|0.2|||MMRM||Asenapine 10 mg BID minus Placebo BID|Day 7||0.2|-1.3|0.1684
72517610|NCT00764478|144564762|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.0|STANDARD_ERROR_OF_MEAN|0.46||0.9522|TWO_SIDED|95.0|-0.9|0.9|||MMRM||Asenapine 5 mg BID minus Placebo BID|Day 14||0.9|-0.9|0.9522
72517611|NCT00764478|144564762|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.9|STANDARD_ERROR_OF_MEAN|0.47||0.0514|TWO_SIDED|95.0|-1.8|0.0|||MMRM||Asenapine 10 mg BID minus Placebo BID|Day 14||0.0|-1.8|0.0514
72491811|NCT00802204|144511921|OTHER||||||<|0.05|||||||t-test, 2 sided|||Paired t-test to compare baseline and post-diet outcome measures||||<0.05
72517612|NCT00764478|144564762|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.9|STANDARD_ERROR_OF_MEAN|0.47||0.0531|TWO_SIDED|95.0|-1.8|0.0|||MMRM||Asenapine 5 mg BID minus Placebo BID|Day 21||0.0|-1.8|0.0531
72517613|NCT00764478|144564762|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-1.3|STANDARD_ERROR_OF_MEAN|0.48||0.0078|TWO_SIDED|95.0|-2.2|-0.3|||MMRM||Asenapine 10 mg BID minus Placebo BID|Day 21||-0.3|-2.2|0.0078
72405116|NCT00805935|144317588|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED|95.0|||||Fisher Exact|||||||1.000
72405117|NCT00805935|144317588|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|||||||1.000
72491812|NCT02701387|144511929|SUPERIORITY_OR_OTHER||||||<|0.01||||||"A 2-factor (implant type x time interval) nonparametric analysis for longitudinal data (Brunner et al. 2002) was used to compare test and control implants across time (baseline + four intervals). The R package nparLD was used (Noguchi et al. 2012)."|nonparametric for longitudinal|||Comparison of ISQ over time. Due to the high number of intervals (T0-T8) relative to the number of observations, data were combined for analysis purposes into 5 comparable intervals as follows: Baseline (T0, unchanged); Tr1=Average of follow-up weeks T1 and T2, Tr2=Average of follow-up weeks T3 and T4; Tr3=Average of follow-up weeks T5 and T6; Tr4=Average of follow-up weeks T7 and T8||||<0.01
72491813|NCT02043548|144511930|SUPERIORITY|||||||0.86|||||||GEE|||||||0.86
72491814|NCT02043548|144511931|SUPERIORITY|||||||0.77|||||||Log Rank|||||||0.77
72491815|NCT02043548|144511932|SUPERIORITY|||||||0.4|||||||binomial test|||||||0.40
72491816|NCT02043548|144511933|SUPERIORITY|||||||0.4|||||||Wilcoxon (Mann-Whitney)|||||||0.40
72491817|NCT02043548|144511934|SUPERIORITY|||||||0.78|||||||GEE|||||||0.78
72491818|NCT02043548|144511934|SUPERIORITY|||||||0.19|||||||t-test, 2 sided|||||||0.19
72491819|NCT03829657|144511950|SUPERIORITY||Odds Ratio (OR)|0.6||||0.196|TWO_SIDED|95.0|0.27|1.29|||Regression, Logistic|||||1.29|0.27|0.196
72491820|NCT00150592|144511978|SUPERIORITY_OR_OTHER_LEGACY|||||||0.844||95.0|||||ANCOVA|||||||0.844
72624783|NCT01346592|144778966|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (B strain)|3.08|||||TWO_SIDED|95.0|2.72|3.49||||||No risk subjects||3.49|2.72|
72624784|NCT01346592|144778966|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (H1N1 strain)|1.71|||||TWO_SIDED|95.0|0.65|4.5||||||At risk subjects.||4.5|0.65|
72624785|NCT01346592|144778966|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (H3N2 strain)|3.22|||||TWO_SIDED|95.0|1.38|7.51||||||At risk subjects.||7.51|1.38|
72624786|NCT01346592|144778966|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (B strain)|2.1|||||TWO_SIDED|95.0|1.1|3.98||||||At risk subjects.||3.98|1.1|
72624787|NCT01346592|144778966|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|GMT ratio (H1N1 strain)|2.59|||||TWO_SIDED|95.0|2.1|3.21||||||No risk subjects.||3.21|2.1|
72624788|NCT01346592|144778966|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|GMT ratio (H3N2 strain)|2.08|||||TWO_SIDED|95.0|1.71|2.52||||||No risk subjects.||2.52|1.71|
72405118|NCT00805935|144317588|SUPERIORITY_OR_OTHER|||||||0.481||95.0|||||Fisher Exact|||Comparing Progesterone vaginal insert to Progesterone in oil within the menotropin treatments arms.||||0.481
72405119|NCT00805935|144317588|SUPERIORITY_OR_OTHER|||||||0.483|TWO_SIDED|95.0|||||Fisher Exact|||Comparing Progesterone vaginal insert to Progesterone in oil within the follitropin beta treatment group.||||0.483
72491821|NCT00150592|144511979|SUPERIORITY_OR_OTHER_LEGACY|||||||0.274||95.0|||||ANCOVA|Mean reaction time (adjusted) for each randomized treatment group at endpoint.||||||0.274
72491822|NCT00150592|144511981|SUPERIORITY_OR_OTHER_LEGACY|||||||0.307||95.0|||||ANCOVA|||Between errors||||0.307
72491823|NCT00150592|144511981|SUPERIORITY_OR_OTHER_LEGACY|||||||0.552||95.0|||||ANCOVA|||Within errors||||0.552
72491824|NCT00150592|144511981|SUPERIORITY_OR_OTHER_LEGACY|||||||0.917||95.0|||||ANCOVA|||Double errors||||0.917
72491825|NCT00150592|144511981|SUPERIORITY_OR_OTHER_LEGACY|||||||0.068||95.0|||||ANCOVA|||Strategy||||0.068
72491826|NCT00150592|144511982|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001||95.0|||||ANCOVA|||||||0.001
72491827|NCT00150592|144511983|SUPERIORITY_OR_OTHER_LEGACY|||||||0.007||95.0|||||Cochran-Mantel-Haenszel|||||||0.007
72491828|NCT00150592|144511984|SUPERIORITY_OR_OTHER_LEGACY|||||||0.02||95.0|||||ANCOVA|||||||0.02
72491829|NCT00150592|144511985|SUPERIORITY_OR_OTHER_LEGACY|||||||0.231||95.0|||||ANCOVA|||||||0.231
72624789|NCT01346592|144778966|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|GMT ratio (B strain)|3.73|||||TWO_SIDED|95.0|3.22|4.33||||||No risk subjects.||4.33|3.22|
72491830|NCT02227693|144511986|OTHER||Difference of responder rate vs. placebo|19.5||||0.146|TWO_SIDED|95.0|-18.1|57.0|||Shirley-Williams test|P-value is based on Shirley-Williams test at a one-sided significance level of α = 0.025.|Difference of responder rate vs. placebo = responder rate for avatrombopag - responder rate for placebo; 95% CI is calculated based on normal approximation.|||57.0|-18.1|0.146
72491831|NCT02227693|144511986|OTHER||Difference of responder rate vs. placebo|54.5||||0.004|TWO_SIDED|95.0|21.4|87.7|||Shirley-Williams test|P-value is based on Shirley-Williams test at a one-sided significance level of α = 0.025.|Difference of responder rate vs. placebo = responder rate for avatrombopag - responder rate for placebo; 95% CI is calculated based on normal approximation.|||87.7|21.4|0.004
72491832|NCT02227693|144511986|OTHER||Difference of responder rate vs. placebo|30.9||||0.024|TWO_SIDED|95.0|-3.9|65.7|||Shirley-Williams test|P-value is based on Shirley-Williams test at a one-sided significance level of α = 0.025.|Difference of responder rate vs. placebo = responder rate for avatrombopag - responder rate for placebo; 95% CI is calculated based on normal approximation.|||65.7|-3.9|0.024
72491833|NCT02227693|144511987|OTHER||Difference of proportion vs. placebo|14.3||||0.388|TWO_SIDED|95.0|-11.6|40.2||P-value is based on Fisher's exact test at a two-sided significance level of α = 0.05.|Fisher Exact||Difference of proportion vs. placebo = proportion of responders for avatrombopag - proportion of responders for placebo; 95% CI is calculated based on normal approximation.|Visit 3 (Day 4 or Day 5)||40.2|-11.6|0.388
72491834|NCT02227693|144511987|OTHER||Difference of proportion vs. placebo|27.3||||0.214|TWO_SIDED|95.0|1.0|53.6||P-value is based on Fisher's exact test at a two-sided significance level of α = 0.05.|Fisher Exact||Difference of proportion vs. placebo = proportion of responders for avatrombopag - proportion of responders for placebo; 95% CI is calculated based on normal approximation.|Visit 3 (Day 4 or Day 5)||53.6|1.0|0.214
72491835|NCT02227693|144511987|OTHER||Difference of proportion vs. placebo|62.3||||0.012|TWO_SIDED|95.0|24.8|99.9||P-value is based on Fisher's exact test at a two-sided significance level of α = 0.05.|Fisher Exact||Difference of proportion vs. placebo = proportion of responders for avatrombopag - proportion of responders for placebo; 95% CI is calculated based on normal approximation.|Visit 4 (Day 10)||99.9|24.8|0.012
72491836|NCT02227693|144511987|OTHER||Difference of proportion vs. placebo|72.7||||0.001|TWO_SIDED|95.0|44.3|100.0||P-value is based on Fisher's exact test at a two-sided significance level of α = 0.05.|Fisher Exact||Difference of proportion vs. placebo = proportion of responders for avatrombopag - proportion of responders for placebo; 95% CI is calculated based on normal approximation.|Visit 4 (Day 10)||100.0|44.3|0.001
72491837|NCT02227693|144511987|OTHER||Difference of proportion vs. placebo|40.9||||0.063|TWO_SIDED|95.0|5.6|76.2||P-value is based on Fisher's exact test at a two-sided significance level of α = 0.05.|Fisher Exact||Difference of proportion vs. placebo = proportion of responders for avatrombopag - proportion of responders for placebo; 95% CI is calculated based on normal approximation.|Visit 4 (Day 10)||76.2|5.6|0.063
72491838|NCT02227693|144511987|OTHER||Difference of proportion vs. placebo|-27.3||||0.245|TWO_SIDED|95.0|-53.6|-1.0||P-value is based on Fisher's exact test at a two-sided significance level of α = 0.05.|Fisher Exact||Difference of proportion vs. placebo = proportion of responders for avatrombopag - proportion of responders for placebo; 95% CI is calculated based on normal approximation.|Visit 5 (Day 17)||-1.0|-53.6|0.245
72491839|NCT02227693|144511987|OTHER||Difference of proportion vs. placebo|27.3||||0.386|TWO_SIDED|95.0|-12.2|66.8||P-value is based on Fisher's exact test at a two-sided significance level of α = 0.05.|Fisher Exact||Difference of proportion vs. placebo = proportion of responders for avatrombopag - proportion of responders for placebo; 95% CI is calculated based on normal approximation.|Visit 5 (Day 17)||66.8|-12.2|0.386
72491840|NCT02227693|144511987|OTHER||Difference of proportion vs. placebo|-7.3||||1|TWO_SIDED|95.0|-43.4|28.9||P-value is based on Fisher's exact test at a two-sided significance level of α = 0.05.|Fisher Exact||Difference of proportion vs. placebo = proportion of responders for avatrombopag - proportion of responders for placebo; 95% CI is calculated based on normal approximation.|Visit 5 (Day 17)||28.9|-43.4|1.000
72491841|NCT02227693|144511987|OTHER||Difference of proportion vs. placebo|-18.2||||0.496|TWO_SIDED|95.0|-41.0|4.6||P-value is based on Fisher's exact test at a two-sided significance level of α = 0.05.|Fisher Exact||Difference of proportion vs. placebo = proportion of responders for avatrombopag - proportion of responders for placebo; 95% CI is calculated based on normal approximation.|Visit 6 (Day 35)||4.6|-41.0|0.496
72491842|NCT02227693|144511987|OTHER||Difference of proportion vs. placebo|-9.1||||1|TWO_SIDED|95.0|-37.5|19.3||P-value is based on Fisher's exact test at a two-sided significance level of α = 0.05.|Fisher Exact||Difference of proportion vs. placebo = proportion of responders for avatrombopag - proportion of responders for placebo; 95% CI is calculated based on normal approximation.|Visit 6 (Day 35)||19.3|-37.5|1.000
72491843|NCT02227693|144511987|OTHER||Difference of proportion vs. placebo|-18.2||||0.476|TWO_SIDED|95.0|-41.0|4.6||P-value is based on Fisher's exact test at a two-sided significance level of α = 0.05.|Fisher Exact||Difference of proportion vs. placebo = proportion of responders for avatrombopag - proportion of responders for placebo; 95% CI is calculated based on normal approximation.|Visit 6 (Day 35)||4.6|-41.0|0.476
72491844|NCT02227693|144511988|OTHER||Difference of proportion vs. placebo|63.6||||0.003|TWO_SIDED|95.0|35.2|92.1||P-value is based on Fisher's exact test at a two-sided significance level of α= 0.05.|Fisher Exact||Difference of proportion vs. placebo = proportion of responders for avatrombopag - proportion of responders for placebo; 95% CI is calculated based on normal approximation.|Visit 4 (Day 10)||92.1|35.2|0.003
72517614|NCT00764478|144564763|SUPERIORITY_OR_OTHER_LEGACY||Least Square (LS) means difference|-0.1|STANDARD_ERROR_OF_MEAN|0.32||0.7746|TWO_SIDED|95.0|-0.7|0.5|||MMRM||Asenapine 5 mg BID minus Placebo BID|Day 7||0.5|-0.7|0.7746
72624790|NCT01346592|144778966|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|GMT ratio (H1N1 strain)|1.4|||||TWO_SIDED|95.0|0.45|4.4||||||At risk subjects.||4.4|0.45|
72405120|NCT01344369|144317622|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|102.44|||||TWO_SIDED|90.0|93.08|112.75|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||112.75|93.08|
72517615|NCT00764478|144564763|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.4|STANDARD_ERROR_OF_MEAN|0.32||0.2754|TWO_SIDED|95.0|-1.0|0.3|||MMRM||Asenapine 10 mg BID minus Placebo BID|Day 7||0.3|-1.0|0.2754
72517616|NCT00764478|144564763|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.0|STANDARD_ERROR_OF_MEAN|0.34||0.9109|TWO_SIDED|95.0|-0.6|0.7|||MMRM||Asenapine 5 mg BID minus Placebo BID|Day 14||0.7|-0.6|0.9109
72517617|NCT00764478|144564763|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.1|STANDARD_ERROR_OF_MEAN|0.34||0.7295|TWO_SIDED|95.0|-0.6|0.8|||MMRM||Asenapine 10 mg BID minus Placebo BID|Day 14||0.8|-0.6|0.7295
72517618|NCT00764478|144564763|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.0|STANDARD_ERROR_OF_MEAN|0.38||0.98|TWO_SIDED|95.0|-0.7|0.8|||MMRM||Asenapine 5 mg BID minus Placebo BID|Day 21||0.8|-0.7|0.9800
72517619|NCT00764478|144564763|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.3|STANDARD_ERROR_OF_MEAN|0.38||0.5122|TWO_SIDED|95.0|-0.5|1.0|||MMRM||Asenapine 10 mg BID minus Placebo BID|Day 21||1.0|-0.5|0.5122
72517620|NCT00764478|144564764|SUPERIORITY_OR_OTHER_LEGACY||Least Square (LS) means difference|-0.4|STANDARD_ERROR_OF_MEAN|0.29||0.2191|TWO_SIDED|95.0|-0.9|0.2|||MMRM||Asenapine 5 mg BID minus Placebo BID|Day 7||0.2|-0.9|0.2191
72517621|NCT00764478|144564764|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.6|STANDARD_ERROR_OF_MEAN|0.29||0.0589|TWO_SIDED|95.0|-1.1|0.0|||MMRM||Asenapine 10 mg BID minus Placebo BID|Day 7||0.0|-1.1|0.0589
72517622|NCT00764478|144564764|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.3|STANDARD_ERROR_OF_MEAN|0.36||0.3683|TWO_SIDED|95.0|-1.0|0.4|||MMRM||Asenapine 5 mg BID minus Placebo BID|Day 14||0.4|-1.0|0.3683
72491845|NCT02227693|144511988|OTHER||Difference of proportion vs. placebo|30.0||||0.09|TWO_SIDED|95.0|1.6|58.4||P-value is based on Fisher's exact test at a two-sided significance level of α= 0.05.|Fisher Exact||Difference of proportion vs. placebo = proportion of responders for avatrombopag - proportion of responders for placebo; 95% CI is calculated based on normal approximation.|Visit 4 (Day 10)||58.4|1.6|0.090
72491846|NCT02227693|144511988|OTHER||Difference of proportion vs. placebo|10.0||||0.476|TWO_SIDED|95.0|-8.6|28.6||P-value is based on Fisher's exact test at a two-sided significance level of α= 0.05.|Fisher Exact||Difference of proportion vs. placebo = proportion of responders for avatrombopag - proportion of responders for placebo; 95% CI is calculated based on normal approximation.|Visit 5 (Day 17)||28.6|-8.6|0.476
72517623|NCT00764478|144564764|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.6|STANDARD_ERROR_OF_MEAN|0.37||0.0982|TWO_SIDED|95.0|-1.3|0.1|||MMRM||Asenapine 10 mg BID minus Placebo BID|Day 14||0.1|-1.3|0.0982
72517624|NCT00764478|144564764|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.5|STANDARD_ERROR_OF_MEAN|0.38||0.1969|TWO_SIDED|95.0|-1.3|0.3|||MMRM||Asenapine 5 mg BID minus Placebo BID|Day 21||0.3|-1.3|0.1969
72517625|NCT00764478|144564764|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.2|STANDARD_ERROR_OF_MEAN|0.39||0.5615|TWO_SIDED|95.0|-1.0|0.5|||MMRM||Asenapine 10 mg BID minus Placebo BID|Day 21||0.5|-1.0|0.5615
72517626|NCT00764478|144564765|SUPERIORITY_OR_OTHER_LEGACY||Least Square (LS) means difference|-0.9|STANDARD_ERROR_OF_MEAN|0.33||0.0101|TWO_SIDED|95.0|-1.5|-0.2|||MMRM||Asenapine 5 mg BID minus Placebo BID|Day 7||-0.2|-1.5|0.0101
72517627|NCT00764478|144564765|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.8|STANDARD_ERROR_OF_MEAN|0.34||0.0146|TWO_SIDED|95.0|-1.5|-0.2|||MMRM||Asenapine 10 mg BID minus Placebo BID|Day 7||-0.2|-1.5|0.0146
72517628|NCT00764478|144564765|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.7|STANDARD_ERROR_OF_MEAN|0.39||0.0861|TWO_SIDED|95.0|-1.4|0.1|||MMRM||Asenapine 5 mg BID minus Placebo BID|Day 14||0.1|-1.4|0.0861
72517629|NCT00764478|144564765|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.8|STANDARD_ERROR_OF_MEAN|0.39||0.0342|TWO_SIDED|95.0|-1.6|-0.1|||MMRM||Asenapine 10 mg BID minus Placebo BID|Day 14||-0.1|-1.6|0.0342
72569352|NCT00444457|144669741|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|0.8|||||TWO_SIDED|95.0|-0.2|2.44|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Additional serotypes - serotype 1||2.44|-0.20|
72491847|NCT02227693|144511991|OTHER|||||||0.296||||||P-value is based on Wilcoxon rank sum test at a two-sided significance level of α = 0.05 for each avatrombopag treatment group vs. placebo.|Wilcoxon (Mann-Whitney)|||Visit 3 (Day 4 or Day 5)||||0.296
72491848|NCT02227693|144511991|OTHER|||||||0.07||||||P-value is based on Wilcoxon rank sum test at a two-sided significance level of α = 0.05 for each avatrombopag treatment group vs. placebo.|Wilcoxon (Mann-Whitney)|||Visit 3 (Day 4 or Day 5)||||0.070
72491849|NCT02227693|144511991|OTHER|||||||0.138||||||P-value is based on Wilcoxon rank sum test at a two-sided significance level of α = 0.05 for each avatrombopag treatment group vs. placebo.|Wilcoxon (Mann-Whitney)|||Visit 3 (Day 4 or Day 5)||||0.138
72491850|NCT02227693|144511991|OTHER|||||||0.012||||||P-value is based on Wilcoxon rank sum test at a two-sided significance level of α = 0.05 for each avatrombopag treatment group vs. placebo.|Wilcoxon (Mann-Whitney)|||Visit 4 (Day 10)||||0.012
72517630|NCT00764478|144564765|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-1.2|STANDARD_ERROR_OF_MEAN|0.4||0.0037|TWO_SIDED|95.0|-2.0|-0.4|||MMRM||Asenapine 5 mg BID minus Placebo BID|Day 21||-0.4|-2.0|0.0037
72517631|NCT00764478|144564765|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-1.1|STANDARD_ERROR_OF_MEAN|0.41||0.0096|TWO_SIDED|95.0|-1.9|-0.3|||MMRM||Asenapine 10 mg BID minus Placebo BID|Day 21||-0.3|-1.9|0.0096
72517632|NCT00764478|144564766|SUPERIORITY_OR_OTHER_LEGACY||Least Square (LS) means difference|-1.0|STANDARD_ERROR_OF_MEAN|0.32||0.0019|TWO_SIDED|95.0|-1.7|-0.4|||MMRM||Asenapine 5 mg BID minus Placebo BID|Day 7||-0.4|-1.7|0.0019
72517633|NCT00764478|144564766|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.6|STANDARD_ERROR_OF_MEAN|0.33||0.0791|TWO_SIDED|95.0|-1.2|0.1|||MMRM||Asenapine 10 mg BID minus Placebo BID|Day 7||0.1|-1.2|0.0791
72569353|NCT00444457|144669741|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|0.0|||||TWO_SIDED|95.0|-1.79|1.66|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Additional serotypes - serotype 1||1.66|-1.79|
72491851|NCT02227693|144511991|OTHER|||||||0.001||||||P-value is based on Wilcoxon rank sum test at a two-sided significance level of α = 0.05 for each avatrombopag treatment group vs. placebo.|Wilcoxon (Mann-Whitney)|||Visit 4 (Day 10)||||0.001
72491852|NCT02227693|144511991|OTHER|||||||0.001||||||P-value is based on Wilcoxon rank sum test at a two-sided significance level of α = 0.05 for each avatrombopag treatment group vs. placebo.|Wilcoxon (Mann-Whitney)|||Visit 4 (Day 10)||||0.001
72491853|NCT02227693|144511991|OTHER|||||||0.624||||||P-value is based on Wilcoxon rank sum test at a two-sided significance level of α = 0.05 for each avatrombopag treatment group vs. placebo.|Wilcoxon (Mann-Whitney)|||Visit 5 (Day 17)||||0.624
72491854|NCT02227693|144511991|OTHER|||||||0.009||||||P-value is based on Wilcoxon rank sum test at a two-sided significance level of α = 0.05 for each avatrombopag treatment group vs. placebo.|Wilcoxon (Mann-Whitney)|||Visit 5 (Day 17)||||0.009
72491855|NCT02227693|144511991|OTHER|||||||0.01||||||P-value is based on Wilcoxon rank sum test at a two-sided significance level of α = 0.05 for each avatrombopag treatment group vs. placebo.|Wilcoxon (Mann-Whitney)|||Visit 5 (Day 17)||||0.010
72491856|NCT02227693|144511991|OTHER|||||||0.154||||||P-value is based on Wilcoxon rank sum test at a two-sided significance level of α = 0.05 for each avatrombopag treatment group vs. placebo.|Wilcoxon (Mann-Whitney)|||Visit 6 (Day 35)||||0.154
72491857|NCT02227693|144511991|OTHER|||||||0.216||||||P-value is based on Wilcoxon rank sum test at a two-sided significance level of α = 0.05 for each avatrombopag treatment group vs. placebo.|Wilcoxon (Mann-Whitney)|||Visit 6 (Day 35)||||0.216
72491858|NCT02227693|144511991|OTHER|||||||0.901||||||P-value is based on Wilcoxon rank sum test at a two-sided significance level of α = 0.05 for each avatrombopag treatment group vs. placebo.|Wilcoxon (Mann-Whitney)|||Visit 6 (Day 35)||||0.901
72491859|NCT00874120|144511998|SUPERIORITY_OR_OTHER||residual error term from the ANOVA|-0.5||||0.548|TWO_SIDED|95.0|-2.0|1.1||P-value is based on an ANOVA model including sequence, subject within sequence, period and treatment as factors.|ANOVA|||||1.1|-2.0|0.5480
72491860|NCT02164981|144512004|SUPERIORITY||Mean Difference (Final Values)|-1.04||||0.57|TWO_SIDED|||||No adjustment for multiple comparisons, as there was only one primary outcome variable.|ANCOVA|||Given the sequential parallel comparison design (SPCD), we used a two-stage test (weighted z-test, Tamura approach: CHANGE\_score = BASELINE\_value + GROUP (i.e., SNP vs. placebo)) to combine the data on treatment effects from phases 1 and 2 (weighted equally). Assessments were on Day -1 (phase 1 baseline), Day 13 (phase 1 outcome, phase 2 baseline) and Day 28 (phase 2 outcome). Only participants who at least started the infusion were included in analysis (i.e., modified intent to treat).||||0.57
72491861|NCT02164981|144512004|SUPERIORITY||Mean Difference (Final Values)|-1.09||||0.54|TWO_SIDED|||||No adjustment for multiple comparisons, as there was only one primary outcome variable.|ANCOVA|||The same analysis as in Analysis 1 was conducted, except that CLOZAPINE (i.e., patient used clozapine vs. other antipsychotic) was added as a covariate.||||0.54
72569354|NCT00444457|144669741|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|2.8|||||TWO_SIDED|95.0|-2.85|8.55|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Additional serotypes - serotype 3||8.55|-2.85|
72491862|NCT02164981|144512005|SUPERIORITY||Mean Difference (Final Values)|-0.62||||0.35|TWO_SIDED|||||Exploratory efficacy outcome, hence no adjustment for multiple comparison.|ANCOVA|||||||0.35
72491863|NCT02164981|144512005|SUPERIORITY||Mean Difference (Final Values)|-0.62||||0.37|TWO_SIDED|||||Exploratory efficacy outcome, hence no adjustment for multiple comparisons|ANCOVA|||||||0.37
72491864|NCT02164981|144512006|SUPERIORITY||Mean Difference (Final Values)|-0.12||||0.85|TWO_SIDED||||||ANCOVA|||||||0.85
72491865|NCT02164981|144512006|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.88|TWO_SIDED||||||ANCOVA|||||||0.88
72491866|NCT02164981|144512007|SUPERIORITY||Mean Difference (Final Values)|-0.19||||0.86|TWO_SIDED||||||ANCOVA|||||||0.86
72491867|NCT02164981|144512007|SUPERIORITY||Mean Difference (Final Values)|-0.23||||0.83|TWO_SIDED||||||ANCOVA|||||||0.83
72491868|NCT02164981|144512013|SUPERIORITY||Mean Difference (Final Values)|1.12||||0.33|TWO_SIDED||||||ANCOVA|||||||0.33
72491869|NCT02164981|144512013|SUPERIORITY||Mean Difference (Final Values)|1.1||||0.34|TWO_SIDED||||||ANCOVA|||||||0.34
72491870|NCT02164981|144512016|SUPERIORITY||Mean Difference (Final Values)|1.11||||0.34|TWO_SIDED||||||ANCOVA|||||||0.34
72491871|NCT02164981|144512016|SUPERIORITY||Mean Difference (Final Values)|2.05||||0.36|TWO_SIDED||||||ANCOVA|||||||0.36
72491872|NCT02404103|144512029|EQUIVALENCE|The primary goal of the current study is to determine the effects of Aerospan on lung function in children with small airway obstruction with two doses.||||||0.148|||||||Mixed Models Analysis|generalized linear mixed-effects models (GLMM) using the identity link function and normal distribution were used||||||.148
72491873|NCT02404103|144512029|EQUIVALENCE|A goal was to evaluate whether flunisolide HFA 320 mcg when compared to flunisolide 160 mcg lead to significantly better improvement in the same outcome measures over time.||||||0.74|||||||Mixed Models Analysis|||||||.740
72491874|NCT02404103|144512029|EQUIVALENCE|generalized linear mixed-effects models (GLMM) using the identity link function and normal distribution were used||||||0.921|||||||Mixed Models Analysis|||||||.921
72491875|NCT02404103|144512030|EQUIVALENCE|The primary goal of the current study is to determine the effects of Aerospan on lung function in children with small airway obstruction.||||||0.872|||||||Mixed Models Analysis|generalized linear mixed-effects models (GLMM) using the identity link function and normal distribution were used||||||.872
72491876|NCT02404103|144512030|EQUIVALENCE|secondary goal was to evaluate whether flunisolide HFA 320 mcg when compared to flunisolide 160 mcg lead to significantly better improvement in the same outcome measures over time.||||||0.82|||||||Mixed Models Analysis|generalized linear mixed-effects models (GLMM) using the identity link function and normal distribution were used||||||0.820
72491877|NCT02404103|144512030|EQUIVALENCE|A goal was to evaluate whether flunisolide HFA 320 mcg when compared to flunisolide 160 mcg lead to significantly better improvement in the same outcome measures over time.||||||0.582|||||||Mixed Models Analysis|||||||0.582
72569355|NCT00444457|144669741|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|-4.9|||||TWO_SIDED|95.0|-9.99|0.21|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Additional serotypes - serotype 3||0.21|-9.99|
72405121|NCT01344369|144317623|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|100.58|||||TWO_SIDED|90.0|96.66|104.66|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||104.66|96.66|
72491878|NCT02404103|144512031|EQUIVALENCE|The primary aim is to compare the average change in spirometric values (FEV1 and FEF25-75%) and AX from baseline to Week 6 from participants randomized flunisolide HFA 1 inhalation BID and to flunisolide HFA 2 inhalations BID.||||||0.782|||||||Mixed Models Analysis|generalized linear mixed-effects models (GLMM) using the identity link function and normal distribution were used.||||||.782
72491879|NCT02404103|144512031|EQUIVALENCE|The primary aim is to compare the average change in spirometric values (FEV1 and FEF25-75%) and AX from baseline to Week 6 from participants randomized flunisolide HFA 1 inhalation BID and to flunisolide HFA 2 inhalations BID.||||||0.906|||||||Mixed Models Analysis|generalized linear mixed-effects models (GLMM) using the identity link function and normal distribution were used.||||||.906
72491880|NCT02404103|144512031|EQUIVALENCE|The primary aim is to compare the average change in spirometric values (FEV1 and FEF25-75%) and AX from baseline to Week 6 from participants randomized flunisolide HFA 1 inhalation BID and to flunisolide HFA 2 inhalations BID.||||||0.102|||||||Mixed Models Analysis|generalized linear mixed-effects models (GLMM) using the identity link function and normal distribution were used.||||||.102
72491881|NCT02404103|144512032|EQUIVALENCE|To assess the impact of flunisolide on small airway parameters using spirometry and impulse oscillometry and determine whether there is a dose-related difference (320 mcg vs 160 mcg) with flunisolide HFA in pediatric patients who have evidence of small airway obstruction.||||||0.62|||||||Mixed Models Analysis|generalized linear mixed-effects models (GLMM) using the identity link function and normal distribution were used.||||||.620
72491882|NCT02404103|144512032|EQUIVALENCE|To assess the impact of flunisolide on small airway parameters using spirometry and impulse oscillometry and determine whether there is a dose-related difference (320 mcg vs 160 mcg) with flunisolide HFA in pediatric patients who have evidence of small airway obstruction.||||||0.543|||||||Mixed Models Analysis|generalized linear mixed-effects models (GLMM) using the identity link function and normal distribution were used||||||.543
72491883|NCT02404103|144512032|EQUIVALENCE|To assess the impact of flunisolide on small airway parameters using spirometry and impulse oscillometry and determine whether there is a dose-related difference (320 mcg vs 160 mcg) with flunisolide HFA in pediatric patients who have evidence of small airway obstruction.||||||0.6|||||||Mixed Models Analysis|generalized linear mixed-effects models (GLMM) using the identity link function and normal distribution were used||||||.6
72491884|NCT00328627|144512033|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.54|||<|0.001|TWO_SIDED|95.0|-0.67|-0.41||For the primary analysis, the overall average HbA1c response of the Alogliptin/pioglitazone combination groups was compared with that of the pioglitazone alone groups at the 2-sided 0.05 significance level with no adjustment for multiple comparisons.|ANCOVA|ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline HbA1c as continuous covariates.||The null hypothesis was that the doses of alogliptin do not have any additive effect on glycemic control (HbA1c) in addition to the effect produced by pioglitazone alone. The alternative hypothesis was that at least the higher dose of alogliptin would have an additive effect on glycemic control (HbA1c) in addition to the effect produced by pioglitazone alone.||-0.41|-0.67|<0.001
72491885|NCT00328627|144512033|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.53|||<|0.001|TWO_SIDED|95.0|-0.66|-0.41|||ANCOVA|ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline HbA1c as continuous covariates.||||-0.41|-0.66|<0.001
72517634|NCT00764478|144564766|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-1.2|STANDARD_ERROR_OF_MEAN|0.36||0.0006|TWO_SIDED|95.0|-2.0|-0.5|||MMRM||Asenapine 5 mg BID minus Placebo BID|Day 14||-0.5|-2.0|0.0006
72517635|NCT00764478|144564766|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.9|STANDARD_ERROR_OF_MEAN|0.37||0.0123|TWO_SIDED|95.0|-1.6|-0.2|||MMRM||Asenapine 10 mg BID minus Placebo BID|Day 14||-0.2|-1.6|0.0123
72517636|NCT00764478|144564766|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-1.1|STANDARD_ERROR_OF_MEAN|0.41||0.0054|TWO_SIDED|95.0|-2.0|-0.3|||MMRM||Asenapine 5 mg BID minus Placebo BID|Day 21||-0.3|-2.0|0.0054
72517637|NCT00764478|144564766|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.9|STANDARD_ERROR_OF_MEAN|0.41||0.035|TWO_SIDED|95.0|-1.7|-0.1|||MMRM||Asenapine 10 mg BID minus Placebo BID|Day 21||-0.1|-1.7|0.0350
72517638|NCT01369212|144564773|SUPERIORITY|||||||0.72|||||||Wald test|Proportion with HBsAg loss at week 240 in each group is estimated by Kaplan-Meier and then equality of proportion is tested using Wald test.||||||0.72
72517639|NCT01369212|144564774|SUPERIORITY|||||||0.09||||||The cumulative percentages with HBsAg loss at week 192 were estimated using Kaplan-Meier method and then the equality is tested using Wald test.|Wald Test|||||||0.09
72517640|NCT01369212|144564775|SUPERIORITY|||||||0.46|||||||Fisher Exact|||||||0.46
72517641|NCT01369212|144564776|SUPERIORITY|||||||0.12|||||||Fisher Exact|||||||0.12
72569356|NCT00444457|144669741|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|-7.7|||||TWO_SIDED|95.0|-13.14|-2.37|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Additional serotypes - serotype 3||-2.37|-13.14|
72569357|NCT00444457|144669741|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|0.3|||||TWO_SIDED|95.0|-1.0|1.84|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Additional serotypes - serotype 5||1.84|-1.00|
72569358|NCT00444457|144669741|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|0.0|||||TWO_SIDED|95.0|-1.27|1.3|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Additional serotypes - serotype 5||1.30|-1.27|
72491886|NCT00328627|144512065|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.7|||<|0.001|TWO_SIDED|95.0|-0.93|-0.48||As a supportive analysis, each of the individual combination treatment groups was compared with the component treatment groups receiving aloliptin alone and pioglitazone alone at the 2-sided 0.05 significance level with no multiplicity adjustment.|ANCOVA|ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline HbA1c as continuous covariates.||||-0.48|-0.93|<0.001
72491887|NCT00328627|144512065|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.59|||<|0.001|TWO_SIDED|95.0|-0.81|-0.38|||ANCOVA|ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline HbA1c as continuous covariates.||||-0.38|-0.81|<0.001
72491888|NCT00328627|144512065|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.37||||0.001|TWO_SIDED|95.0|-0.59|-0.15|||ANCOVA|ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline HbA1c as continuous covariates.||||-0.15|-0.59|0.001
72491889|NCT00328627|144512065|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.52|||<|0.001|TWO_SIDED|95.0|-0.74|-0.3|||ANCOVA|ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline HbA1c as continuous covariates.||||-0.30|-0.74|<0.001
72491890|NCT00328627|144512065|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.76|||<|0.001|TWO_SIDED|95.0|-0.98|-0.53|||ANCOVA|ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline HbA1c as continuous covariates.||||-0.53|-0.98|<0.001
72491891|NCT00328627|144512065|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.47|||<|0.001|TWO_SIDED|95.0|-0.7|-0.25|||ANCOVA|ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline HbA1c as continuous covariates.||||-0.25|-0.70|<0.001
72491892|NCT00328627|144512065|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.49|||<|0.001|TWO_SIDED|95.0|-0.71|-0.27|||ANCOVA|ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline HbA1c as continuous covariates.||||-0.27|-0.71|<0.001
72491893|NCT00328627|144512065|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.47|||<|0.001|TWO_SIDED|95.0|-0.7|-0.25|||ANCOVA|ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline HbA1c as continuous covariates.||||-0.25|-0.70|<0.001
72624791|NCT01346592|144778966|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|GMT ratio (H3N2 strain)|2.86|||||TWO_SIDED|95.0|0.94|8.66||||||At risk subjects.||8.66|0.94|
72491894|NCT00328627|144512065|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.91|||<|0.001|TWO_SIDED|95.0|-1.13|-0.68|||ANCOVA|ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline HbA1c as continuous covariates.||||-0.68|-1.13|<0.001
72491895|NCT00328627|144512065|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.55|||<|0.001|TWO_SIDED|95.0|-0.77|-0.33|||ANCOVA|ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline HbA1c as continuous covariates.||||-0.33|-0.77|<0.001
72491896|NCT00328627|144512065|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.7|||<|0.001|TWO_SIDED|95.0|-0.92|-0.48|||ANCOVA|ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline HbA1c as continuous covariates.||||-0.48|-0.92|<0.001
72491897|NCT00328627|144512065|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.61|||<|0.001|TWO_SIDED|95.0|-0.83|-0.39|||ANCOVA|ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline HbA1c as continuous covariates.||||-0.39|-0.83|<0.001
72491898|NCT03548051|144512201|SUPERIORITY||Difference in Proportions|0.05|||>|0.999|TWO_SIDED|95.0|-0.58|0.65||No adjustment for multiple comparisons was made. The a priori threshold for statistical significance is 0.05.|Fisher Exact|||The null hypothesis is that there is no difference in proportions between study arms, with a two-sided alternative.||0.65|-0.58|>0.999
72491899|NCT03548051|144512204|SUPERIORITY||Difference in Proportions|0.05|||>|0.999|TWO_SIDED|95.0|-0.58|0.65||No adjustment for multiple comparisons was made. The a priori threshold for statistical significance is 0.05.|Fisher Exact|||The null hypothesis is that there is no difference in proportions between study arms, with a two-sided alternative.||0.65|-0.58|>0.999
72491900|NCT03548051|144512205|SUPERIORITY||||||>|0.999||||||No adjustment for multiple comparisons was made. The a priori threshold for statistical significance is 0.05.|Log Rank|||A Log-Rank permutation test for small samples was used to test the null hypothesis that there is no difference in the time to first CDAD recurrence between treatment arms.||||>0.999
72491901|NCT01745146|144512225|EQUIVALENCE|Primary outcome is difference in rates of treatment response between the ASMT and the PRE, where treatment response is defined as ≥ 1 SD improvement in self-reported anger on at least 1 of 3 target scales from pre- to 1-2 wk post treatment. The treatment will be considered supported if the observed response rate with ASMT is at least 20 percentage points higher than that with the control treatment, PRE.||||||0.047||||||Alpha was set at .05 both for the a priori hypotheses and also for secondary analyses|Chi-squared|Pearson's chi-square test||Significance of difference in post-treatment response rate for STAXI-2 Trait Anger. Missing outcomes reported at non-responders.||||0.047
72491902|NCT01745146|144512225|EQUIVALENCE|Primary outcome is difference in rates of treatment response between the ASMT and the PRE, where treatment response is defined as ≥ 1 SD improvement in self-reported anger on at least 1 of 3 target scales from pre- to 1-2 wk post treatment. The treatment will be considered supported if the observed response rate with ASMT is at least 20 percentage points higher than that with the control treatment, PRE.||||||0.549||||||Alpha was set at .05 both for the a priori hypotheses and also for secondary analyses|Chi-squared|Pearson's chi-square test||Significance of difference in post-treatment response rate for STAXI-2 Anger Expression-Out. Missing outcomes reported at non-responders.||||0.549
72624792|NCT01346592|144778966|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|GMT ratio (B strain)|1.4|||||TWO_SIDED|95.0|0.45|4.4||||||At risk subjects.||4.4|0.45|
72517642|NCT01369212|144564777|SUPERIORITY|||||||0.002|||||||Fisher Exact|||||||0.002
72517643|NCT01369212|144564778|SUPERIORITY|||||||0.039|||||||Fisher Exact|||||||0.039
72517644|NCT01369212|144564779|SUPERIORITY|||||||0.2|||||||Fisher Exact|||||||0.20
72517645|NCT01369212|144564780|SUPERIORITY|||||||0.44|||||||Fisher Exact|||||||0.44
72517646|NCT01369212|144564781|SUPERIORITY|||||||0.06|||||||Fisher Exact|||||||0.06
72405122|NCT01344369|144317624|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|100.85|||||TWO_SIDED|90.0|96.43|105.48|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||105.48|96.43|
72491903|NCT01745146|144512225|EQUIVALENCE|Primary outcome is difference in rates of treatment response between the ASMT and the PRE, where treatment response is defined as ≥ 1 SD improvement in self-reported anger on at least 1 of 3 target scales from pre- to 1-2 wk post treatment. The treatment will be considered supported if the observed response rate with ASMT is at least 20 percentage points higher than that with the control treatment, PRE.||||||0.511||||||Alpha was set at .05 both for the a priori hypotheses and also for secondary analyses|Chi-squared|Pearson's chi-square test||Significance of difference in post-treatment response rate for BAAQ. Missing outcomes reported at non-responders.||||0.511
72491904|NCT01745146|144512225|EQUIVALENCE|Primary outcome is difference in rates of treatment response between the ASMT and the PRE, where treatment response is defined as ≥ 1 SD improvement in self-reported anger on at least 1 of 3 target scales from pre- to 1-2 wk post treatment. The treatment will be considered supported if the observed response rate with ASMT is at least 20 percentage points higher than that with the control treatment, PRE.||||||0.031||||||Alpha was set at .05 both for the a priori hypotheses and also for secondary analyses|Chi-squared|Pearson's chi-square test||Significance of difference in post-treatment response rate for STAXI-2 Trait Anger. Missing outcomes excluded for this analysis.||||0.031
72491905|NCT01745146|144512225|EQUIVALENCE|Primary outcome is difference in rates of treatment response between the ASMT and the PRE, where treatment response is defined as ≥ 1 SD improvement in self-reported anger on at least 1 of 3 target scales from pre- to 1-2 wk post treatment. The treatment will be considered supported if the observed response rate with ASMT is at least 20 percentage points higher than that with the control treatment, PRE.||||||0.483||||||Alpha was set at .05 both for the a priori hypotheses and also for secondary analyses|Chi-squared|Pearson's chi-square test||Significance of difference in post-treatment response rate for STAXI-2 Anger Expression-Out. Missing outcomes excluded for this analysis.||||0.483
72491906|NCT01745146|144512225|EQUIVALENCE|Primary outcome is difference in rates of treatment response between the ASMT and the PRE, where treatment response is defined as ≥ 1 SD improvement in self-reported anger on at least 1 of 3 target scales from pre- to 1-2 wk post treatment. The treatment will be considered supported if the observed response rate with ASMT is at least 20 percentage points higher than that with the control treatment, PRE.||||||0.53||||||Alpha was set at .05 both for the a priori hypotheses and also for secondary analyses|Chi-squared|Pearson's chi-square test||Significance of difference in post-treatment response rate for BAAQ. Missing outcomes excluded for this analysis.||||0.530
72491907|NCT01745146|144512225|EQUIVALENCE|Primary outcome is difference in rates of treatment response between the ASMT and the PRE, where treatment response is defined as ≥ 1 SD improvement in self-reported anger on at least 1 of 3 target scales from pre- to 1-2 wk post treatment. The treatment will be considered supported if the observed response rate with ASMT is at least 20 percentage points higher than that with the control treatment, PRE.||||||0.421||||||Alpha was set at .05 both for the a priori hypotheses and also for secondary analyses|Chi-squared|Pearson's Chi-squared||Significance of difference in overall post-treatment response rate. Missing outcomes included as non-responders.||||0.421
72491908|NCT01745146|144512225|EQUIVALENCE|Primary outcome is difference in rates of treatment response between the ASMT and the PRE, where treatment response is defined as ≥ 1 SD improvement in self-reported anger on at least 1 of 3 target scales from pre- to 1-2 wk post treatment. The treatment will be considered supported if the observed response rate with ASMT is at least 20 percentage points higher than that with the control treatment, PRE.||||||0.332||||||Alpha was set at .05 both for the a priori hypotheses and also for secondary analyses|Chi-squared|Pearson's Chi-squared||Significance of difference in overall post-treatment response rate. Missing outcomes excluded for this analysis.||||0.332
72491909|NCT01877187|144512236|OTHER|||||||0.06||||||Statistical significance defined as p \<= .05. Result is for Day 30 timepoint.|Wilcoxon (Mann-Whitney)|||Sample size of 60 achieves 80% power to detect a Pearson correlation coefficient of 0.35 with a two-sided significant level of 0.05. Sample size of 30 will allow for detecting a Pearson correlation coefficient of 0.49 in each subgroup.||||.06
72491910|NCT01877187|144512236|OTHER|||||||0.09||||||Statistical significance defined as p \<= 0.05. Data for 90 day timepoint.|Wilcoxon (Mann-Whitney)|||Sample size of 60 achieves 80% power to detect a Pearson correlation coefficient of 0.35 with a two-sided significant level of 0.05. Sample size of 30 will allow for detecting a Pearson correlation coefficient of 0.49 in each subgroup.||||.09
72517647|NCT01369212|144564782|SUPERIORITY|||||||0.66|||||||Fisher Exact|||||||0.66
72517648|NCT01369212|144564783|SUPERIORITY|||||||0.02|||||||Fisher Exact|||||||0.02
72517649|NCT01369212|144564784|SUPERIORITY|||||||0.55|||||||Fisher Exact|||||||0.55
72517650|NCT01369212|144564785|SUPERIORITY||||||>|0.99|||||||Fisher Exact|||||||>0.99
72491911|NCT01877187|144512236|OTHER|||||||0.034||||||Statistical significance defined as p \<= 0.05. Data for 180 day timepoint.|Wilcoxon (Mann-Whitney)|||Sample size of 60 achieves 80% power to detect a Pearson correlation coefficient of 0.35 with a two-sided significant level of 0.05. Sample size of 30 will allow for detecting a Pearson correlation coefficient of 0.49 in each subgroup.||||0.034
72491912|NCT01877187|144512238|OTHER|||||||0.19||||||Statistical significance defined as p \<= 0.05. Data for 30 day timepoint.|Wilcoxon (Mann-Whitney)|||Sample size of 60 achieves 80% power to detect a Pearson correlation coefficient of 0.35 with a two-sided significant level of 0.05. Sample size of 30 will allow for detecting a Pearson correlation coefficient of 0.49 in each subgroup.||||0.19
72517651|NCT01369212|144564786|SUPERIORITY|||||||0.87|||||||Fisher Exact|||||||0.87
72517652|NCT01369212|144564787|SUPERIORITY|||||||0.02|||||||Fisher Exact|||||||0.02
72517653|NCT01369212|144564788|SUPERIORITY|||||||0.66|||||||Fisher Exact|||||||0.66
72517654|NCT01369212|144564790|SUPERIORITY|||||||0.66|||||||Log Rank|||||||0.66
72517655|NCT01369212|144564791|SUPERIORITY|||||||0.01|||||||Fisher Exact|||||||0.01
72569359|NCT00444457|144669741|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|-0.3|||||TWO_SIDED|95.0|-1.84|1.02|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Additional serotypes - serotype 5||1.02|-1.84|
72569360|NCT00444457|144669741|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|0.0|||||TWO_SIDED|95.0|-1.04|1.08|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Additional serotypes - serotype 6A||1.08|-1.04|
72569361|NCT00444457|144669741|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|0.3|||||TWO_SIDED|95.0|-0.76|1.56|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Additional serotypes - serotype 6A||1.56|-0.76|
72569362|NCT00444457|144669741|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|0.3|||||TWO_SIDED|95.0|-0.83|1.56|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Additional serotypes - serotype 6A||1.56|-0.83|
72569363|NCT00444457|144669741|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|0.6|||||TWO_SIDED|95.0|-0.47|2.09|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Additional serotypes - serotype 7F||2.09|-0.47|
72569364|NCT00444457|144669741|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|0.6|||||TWO_SIDED|95.0|-0.48|2.0|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Additional serotypes - serotype 7F||2.00|-0.48|
72569365|NCT00444457|144669741|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|0.0|||||TWO_SIDED|95.0|-1.59|1.49|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Additional serotypes - serotype 7F||1.49|-1.59|
72569366|NCT00444457|144669741|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|0.0|||||TWO_SIDED|95.0|-1.04|1.09|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Additional serotypes - serotype 19A||1.09|-1.04|
72569367|NCT00444457|144669741|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|0.0|||||TWO_SIDED|95.0|-1.05|1.04|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Additional serotypes - serotype 19A||1.04|-1.05|
72569368|NCT00444457|144669741|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|0.0|||||TWO_SIDED|95.0|-1.09|1.07|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Additional serotypes - serotype 19A||1.07|-1.09|
72569369|NCT00444457|144669743|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|-1.4|||||TWO_SIDED|95.0|-6.52|3.63|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Common serotypes - serotype 4||3.63|-6.52|
72569370|NCT00444457|144669743|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|-6.7|||||TWO_SIDED|95.0|-11.3|-2.15|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Common serotypes - serotype 4||-2.15|-11.30|
72624793|NCT01346592|144778966|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|GMT ratio (H1N1 strain)|3.67|||||TWO_SIDED|95.0|2.97|4.54||||||No risk subjects.||4.54|2.97|
72569371|NCT00444457|144669743|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|-5.2|||||TWO_SIDED|95.0|-9.85|-0.79|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Common serotypes - serotype 4||-0.79|-9.85|
72569372|NCT00444457|144669743|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|0.3|||||TWO_SIDED|95.0|-1.19|2.07|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Common serotypes - serotype 6B||2.07|-1.19|
72569373|NCT00444457|144669743|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|-0.3|||||TWO_SIDED|95.0|-1.69|1.06|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Common serotypes - serotype 6B||1.06|-1.69|
72624794|NCT01346592|144778966|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|GMT ratio (H3N2 strain)|2.78|||||TWO_SIDED|95.0|2.29|3.37||||||No risk subjects.||3.37|2.29|
72624795|NCT01346592|144778966|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|GMT ratio (B strain)|4.01|||||TWO_SIDED|95.0|3.46|4.65||||||No risk subjects.||4.65|3.46|
72624796|NCT01346592|144778966|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|GMT ratio (H1N1 strain)|1.4|||||TWO_SIDED|95.0|0.45|4.4||||||At risk subjects.||4.4|0.45|
72569374|NCT00444457|144669743|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|-0.6|||||TWO_SIDED|95.0|-2.27|0.75|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Common serotypes - serotype 6B||0.75|-2.27|
72624797|NCT01346592|144778966|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (H3N2 strain)|4.32|||||TWO_SIDED|95.0|1.43|13.0||||||At risk subjects.||13|1.43|
72624798|NCT01346592|144778966|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (B strain)|3.69|||||TWO_SIDED|95.0|1.67|8.15||||||At risk subjects.||8.15|1.67|
72405123|NCT01344369|144317625|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|100.59|||||TWO_SIDED|90.0|93.69|108.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||108.00|93.69|
72405124|NCT01344369|144317626|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|96.68|||||TWO_SIDED|90.0|92.76|100.77|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||100.77|92.76|
72405125|NCT01344369|144317627|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|96.44|||||TWO_SIDED|90.0|92.22|100.84|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||100.84|92.22|
72491913|NCT01877187|144512238|OTHER|||||||0.011||||||Statistical significance defined as p \<= 0.05. Data for 90 day timepoint.|Wilcoxon (Mann-Whitney)|||Sample size of 60 achieves 80% power to detect a Pearson correlation coefficient of 0.35 with a two-sided significant level of 0.05. Sample size of 30 will allow for detecting a Pearson correlation coefficient of 0.49 in each subgroup.||||0.011
72491914|NCT01877187|144512238|OTHER|||||||0.94||||||Statistical significance defined as p \<= 0.05. Data for 180 day timepoint.|Wilcoxon (Mann-Whitney)|||Sample size of 60 achieves 80% power to detect a Pearson correlation coefficient of 0.35 with a two-sided significant level of 0.05. Sample size of 30 will allow for detecting a Pearson correlation coefficient of 0.49 in each subgroup.||||0.94
72491915|NCT01877187|144512240|OTHER|||||||0.06||||||Statistical significance defined as p \<= 0.05. Data for 30 day timepoint.|Wilcoxon (Mann-Whitney)|||Sample size of 60 achieves 80% power to detect a Pearson correlation coefficient of 0.35 with a two-sided significant level of 0.05. Sample size of 30 will allow for detecting a Pearson correlation coefficient of 0.49 in each subgroup.||||0.06
72491916|NCT01877187|144512240|OTHER|||||||0.017||||||Statistical significance defined as p \<= 0.05. Data for 90 day timepoint.|Wilcoxon (Mann-Whitney)|||Sample size of 60 achieves 80% power to detect a Pearson correlation coefficient of 0.35 with a two-sided significant level of 0.05. Sample size of 30 will allow for detecting a Pearson correlation coefficient of 0.49 in each subgroup.||||0.017
72491917|NCT01877187|144512240|OTHER|||||||0.08||||||Statistical significance defined as p \<= 0.05. Data for 90 day timepoint.|Wilcoxon (Mann-Whitney)|||Sample size of 60 achieves 80% power to detect a Pearson correlation coefficient of 0.35 with a two-sided significant level of 0.05. Sample size of 30 will allow for detecting a Pearson correlation coefficient of 0.49 in each subgroup.||||0.08
72491918|NCT01877187|144512242|OTHER|||||||0.02||||||Statistical significance defined as p \<= 0.05. Data for 30 day timepoint.|Wilcoxon (Mann-Whitney)|||Sample size of 60 achieves 80% power to detect a Pearson correlation coefficient of 0.35 with a two-sided significant level of 0.05. Sample size of 30 will allow for detecting a Pearson correlation coefficient of 0.49 in each subgroup.||||0.020
72491919|NCT01877187|144512242|OTHER|||||||0.029||||||Statistical significance defined as p \<= 0.05. Data for 90 day timepoint.|Wilcoxon (Mann-Whitney)|||Sample size of 60 achieves 80% power to detect a Pearson correlation coefficient of 0.35 with a two-sided significant level of 0.05. Sample size of 30 will allow for detecting a Pearson correlation coefficient of 0.49 in each subgroup.||||0.029
72491920|NCT01877187|144512242|OTHER|||||||0.94||||||Statistical significance defined as p \<= 0.05. Data for 180 day timepoint.|Wilcoxon (Mann-Whitney)|||Sample size of 60 achieves 80% power to detect a Pearson correlation coefficient of 0.35 with a two-sided significant level of 0.05. Sample size of 30 will allow for detecting a Pearson correlation coefficient of 0.49 in each subgroup.||||0.94
72405126|NCT02223767|144317733|SUPERIORITY|||||||0.025|||||||t-test, 1 sided|||||||0.025
72491921|NCT01877187|144512244|OTHER|||||||0.06||||||Statistical significance defined as p \<= 0.05. Data for 30 day timepoint.|Wilcoxon (Mann-Whitney)|||Sample size of 60 achieves 80% power to detect a Pearson correlation coefficient of 0.35 with a two-sided significant level of 0.05. Sample size of 30 will allow for detecting a Pearson correlation coefficient of 0.49 in each subgroup.||||0.06
72491922|NCT01877187|144512244|OTHER|||||||0.013||||||Statistical significance defined as p \<= 0.05. Data for 90 day timepoint.|Wilcoxon (Mann-Whitney)|||Sample size of 60 achieves 80% power to detect a Pearson correlation coefficient of 0.35 with a two-sided significant level of 0.05. Sample size of 30 will allow for detecting a Pearson correlation coefficient of 0.49 in each subgroup.||||0.013
72491923|NCT01877187|144512244|OTHER|||||||0.67||||||Statistical significance defined as p \<= 0.05. Data for 180 day timepoint.|Wilcoxon (Mann-Whitney)|||Sample size of 60 achieves 80% power to detect a Pearson correlation coefficient of 0.35 with a two-sided significant level of 0.05. Sample size of 30 will allow for detecting a Pearson correlation coefficient of 0.49 in each subgroup.||||0.67
72491924|NCT01789814|144512271|SUPERIORITY_OR_OTHER|||||||0.001||||||Prasugrel treatment when compared to Clopidogrel was associated with significant reduction in platelets aggregation for all plateles agonist (ADD, SFFFLRN, AYPGKF) at all measured time points.|t-test, 2 sided|||Each patient will have paired samples representing their baseline as well as an on-drug sample. The magnitude of platelet inhibition for each studied agonist will be performed utilizing mean maximal change from baseline in light transmission aggregometry. The paired samples will be analyzed using a two-tailed student's t-test. Statistical significance will be assumed to occur when p\<0.05.||||0.001
72405127|NCT02223767|144317734|SUPERIORITY|||||||0.08|||||||t-test, 1 sided|||||||0.08
72405128|NCT00048542|144317842|SUPERIORITY_OR_OTHER|||||||0.031||95.0|||||Chi-square test|||The study was sized to detect a difference in the proportion of subjects (40%) between placebo and the active adalimumab dose group who would experience disease flare assuming a placebo rate of 70% vs. a rate of 30% in the active group. Assuming a binomial distribution, an alpha of 0.05, 80% power, two-sided test, and an initial monotherapy responder rate of 70%, a minimum of 29 subjects were needed per treatment group within the appropriate strata.||||0.031
72491925|NCT01289015|144512291|SUPERIORITY_OR_OTHER||p-value|0.001|||<|0.025||95.0|||||Cochran-Mantel-Haenszel|The CMH test statistic after stratification was used to compare subjects with complete cure between NAFT-600 and placebo.||"In order to compare complete cure rate in the NAFT-600 group with that of the placebo group, the following one-sided hypothesis test was carried out:~H0 (null): p1\<=p0 versus Ha (alternate): p1\>p0, where p0 and p1 are the proportions of subjects with complete cure in the proportions of subjects with complete cure in the placebo and NAFT-600 treatment groups respectively."||||<0.025
72491926|NCT00428974|144512293|SUPERIORITY|||||||0.031|||||||t-test, 1 sided|||12 weeks, 2mg CF101 vs. Placebo||||0.031
72491927|NCT00428974|144512294|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05|TWO_SIDED|95.0|||||Fisher Exact|||||||<0.05
72491928|NCT01425203|144512318|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference in Percentages|29.2|||<|0.0001|TWO_SIDED|95.0|16.4|41.5||Multiplicity adjustment for controlling type 1 error for the primary comparison was based on the step-down approach.|Miettinen and Nurminen Method||The difference, 95% CI and p-value are adjusted by stratification factors of IL-28B genotype and previous treatment, based on the Miettinen \& Nurminen method.|The primary statistical comparison was conducted on the FAS using the stratified Miettinen and Nurminen method at alpha level of 0.050 adjusted for stratification factors, including IL28B genotype and previous treatment as specified at the time of randomization.||41.5|16.4|<0.0001
72491929|NCT01425203|144512319|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference in Percentages|30.2|||<|0.0001|TWO_SIDED|95.0|17.3|42.5||Multiplicity adjustment for controlling type 1 error for key secondary comparison based on a step-down approach. Key-secondary comparison was tested only if statistical significance of primary comparison was met at alpha level of 0.050.|Miettinen and Nurminen Method||The difference, 95% CI and p-value are adjusted by stratification factors of IL-28B genotype and previous treatment, based on the Miettinen \& Nurminen method.|The key secondary statistical comparison was conducted on the mITT using the stratified Miettinen and Nurminen method at alpha level of 0.050 adjusted for stratification factors.||42.5|17.3|<0.0001
72491930|NCT01425203|144512320|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference in Percentages|45.6|||<|0.0001|TWO_SIDED|95.0|33.2|57.0|||Miettinen and Nurminen Method||The difference, 95% CI and p-value are adjusted by stratification factors of IL-28B genotype and previous treatment, based on the Miettinen \& Nurminen method.|The percentage of participants achieving EVR at TW8 was compared using the stratified Miettinen and Nurminen method at alpha level of 0.050 adjusted for stratification factors in the FAS population.||57.0|33.2|<0.0001
72491931|NCT00382993|144512332|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.63|||<|0.001||95.0|2.76|11.49|||ANOVA|||||11.49|2.76|<0.001
72491932|NCT03016325|144512369|SUPERIORITY|Part I, clinically relevant hypotension - relative risk|Relative risk from placebo|2.45|||||TWO_SIDED|95.0|0.83|14.53||||||||14.53|0.83|
72491933|NCT03016325|144512369|SUPERIORITY|Part I, clinically relevant hypotension - relative difference|Relative difference from placebo|0.12|||||TWO_SIDED|95.0|-0.02|0.28||||||||0.28|-0.02|
72491934|NCT03016325|144512369|SUPERIORITY|Part I, symptoms of hypotension - relative risk|Relative risk from placebo|2.94|||||TWO_SIDED|95.0|0.31|75.47||||||||75.47|0.31|
72491935|NCT03016325|144512369|SUPERIORITY|Part I, symptoms of hypotension - relative difference|Relative difference from placebo|0.04|||||TWO_SIDED|95.0|-0.06|0.15||||||||0.15|-0.06|
72569375|NCT00444457|144669743|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|-3.8|||||TWO_SIDED|95.0|-9.46|1.82|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Common serotypes - serotype 9V||1.82|-9.46|
72569376|NCT00444457|144669743|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|-4.7|||||TWO_SIDED|95.0|-10.24|0.76|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Common serotypes - serotype 9V||0.76|-10.24|
72491936|NCT03016325|144512369|SUPERIORITY|Part I, confirmed SBP \< 90 mmHg - relative risk|Relative risk from placebo|3.27|||||TWO_SIDED|95.0|1.01|14.66||||||||14.66|1.01|
72624799|NCT01346592|144778966|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (H1N1 strain)|1.35|||||TWO_SIDED|95.0|0.89|2.04||||||No risk subjects.||2.04|0.89|
72491937|NCT03016325|144512369|SUPERIORITY|Part I, confirmed SBP \< 90 mmHg - relative difference|Relative difference from placebo|0.14|||||TWO_SIDED|95.0|0.0|0.29||||||||0.29|0.00|
72624800|NCT01346592|144778966|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (H3N2 strain)|1.59|||||TWO_SIDED|95.0|1.14|2.22||||||No risk subjects.||2.22|1.14|
72491938|NCT03016325|144512369|SUPERIORITY|Part II (low dose), clinically relevant hypotension - relative risk|Relative risk from placebo|1.15|||||TWO_SIDED|95.0|0.58|2.43||||||||2.43|0.58|
72491939|NCT03016325|144512369|SUPERIORITY|Part II (low dose), clinically relevant hypotension - relative difference|Relative difference from placebo|0.03|||||TWO_SIDED|95.0|-0.11|0.16||||||||0.16|-0.11|
72624801|NCT01346592|144778966|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (B strain)|1.68|||||TWO_SIDED|95.0|1.3|2.15||||||No risk subjects.||2.15|1.3|
72624802|NCT01346592|144778966|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (H1N1 strain)|1.73|||||TWO_SIDED|95.0|0.29|10.0||||||At risk subjects.||10|0.29|
72624803|NCT01346592|144778966|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (H3N2 strain)|1.16|||||TWO_SIDED|95.0|0.33|4.01||||||At risk subjects.||4.01|0.33|
72405129|NCT00048542|144317844|SUPERIORITY_OR_OTHER|||||||0.015||95.0|||||Chi-square test|||||||0.015
72405130|NCT00048542|144317845|SUPERIORITY_OR_OTHER|||||||0.029||95.0|||||Log Rank|||||||0.029
72491940|NCT03016325|144512369|SUPERIORITY|Part II (low dose), symptoms of hypotension - relative risk|Relative risk from placebo|2.0|||||TWO_SIDED|95.0|0.18|54.35||||||||54.35|0.18|
72405131|NCT00048542|144317846|SUPERIORITY_OR_OTHER|||||||0.031||95.0|||||Log Rank|||||||0.031
72491941|NCT03016325|144512369|SUPERIORITY|Part II (low dose), symptoms of hypotension - relative difference|Relative difference from placebo|0.01|||||TWO_SIDED|95.0|-0.05|0.09||||||||0.09|-0.05|
72491942|NCT03016325|144512369|SUPERIORITY|Part II (low dose), confirmed SBP \< 90 mmHg - relative risk|Relative risk from placebo|1.15|||||TWO_SIDED|95.0|0.58|2.43||||||||2.43|0.58|
72517656|NCT00862121|144564792|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.212||||0.231|TWO_SIDED|95.0|0.017|2.683|||Regression, Logistic|||The odds ratio (OR) for Baseline CDAI measures the effect of an increase of one unit on the outcome. The OR \[95% CI\] and p-value (likelihood-based) are for Pentasa versus placebo estimated in a logistic regression analysis including TREATMENT and CDAI at baseline as covariates. Power to demonstrate superiority of PENTASA Sachet 6 g/day over placebo in the primary efficacy analysis was 90% for a planned sample size of 255 participants per treatment arm (assuming 10% nonassessable participants).||2.683|0.017|0.231
72405132|NCT00048542|144317847|SUPERIORITY_OR_OTHER|||||||0.061||95.0|||||Pearson's Chi-square test|||||||0.061
72491943|NCT03016325|144512369|SUPERIORITY|Part II (low dose), confirmed SBP \< 90 mmHg - relative difference|Relative difference from placebo|0.03|||||TWO_SIDED|95.0|-0.11|0.16||||||||0.16|-0.11|
72491944|NCT03016325|144512369|SUPERIORITY|Part II (high dose), clinically relevant hypotension - relative risk|Relative risk from placebo|1.9|||||TWO_SIDED|95.0|1.04|3.59||||||||3.59|1.04|
72569377|NCT00444457|144669743|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|-0.9|||||TWO_SIDED|95.0|-6.3|4.41|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Common serotypes - serotype 9V||4.41|-6.30|
72405133|NCT00048542|144317847|SUPERIORITY_OR_OTHER|||||||0.028||95.0|||||Pearson's Chi-square test|||||||0.028
72405134|NCT00048542|144317848|SUPERIORITY_OR_OTHER|||||||0.103||95.0|||||Pearson's Chi-square test|||||||0.103
72405135|NCT00048542|144317848|SUPERIORITY_OR_OTHER|||||||0.028||95.0|||||Pearson's Chi-square test|||||||0.028
72405136|NCT00048542|144317849|SUPERIORITY_OR_OTHER|||||||0.156||95.0|||||Pearson's Chi-square test|||||||0.156
72405137|NCT00048542|144317849|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||Pearson's Chi-square test|||||||0.002
72491945|NCT03016325|144512369|SUPERIORITY|Part II (high dose), clinically relevant hypotension - relative difference|Relative difference from placebo|0.16|||||TWO_SIDED|95.0|0.01|0.31||||||||0.31|0.01|
72491946|NCT03016325|144512369|SUPERIORITY|Part II (high dose), symptoms of hypotension - relative risk|Relative risk from placebo|5.92|||||TWO_SIDED|95.0|0.91|149.72||||||||149.72|0.91|
72491947|NCT03016325|144512369|SUPERIORITY|Part II (high dose), symptoms of hypotension - relative difference|Relative difference from placebo|0.07|||||TWO_SIDED|95.0|-0.01|0.16||||||||0.16|-0.01|
72491948|NCT03016325|144512369|SUPERIORITY|Part II (high dose), confirmed SBP \< 90 mmHg - relative risk|Relative risk from placebo|1.59|||||TWO_SIDED|95.0|0.87|3.21||||||||3.21|0.87|
72405138|NCT02272413|144317889|EQUIVALENCE|The null hypothesis was to be rejected in favor of equivalence if the 2-sided 90% confidence interval (CI) for the ratio in best ORR between the treatments was entirely contained within the equivalence margins of 0.736 to 1.359.|Ratio of best ORR|0.855|||||TWO_SIDED|90.0|0.7697|0.9506|||Log-binomial regression|||Analysis was based on a log-binomial regression model with subsequent transformation of the estimated parameter (ratio of best ORR) respective CIs to the ratio scale. The model included the following explanatory variables: treatment, sex (male versus female), smoking status (never smoked versus current/ex-smoker), NSCLC stage (recurrent versus Stage IV) and ethnicity (East Asian origin versus Non-East Asian).||0.9506|0.7697|
72491949|NCT03016325|144512369|SUPERIORITY|Part II (high dose), confirmed SBP \< 90 mmHg - relative difference|Relative difference from placebo|0.11|||||TWO_SIDED|95.0|-0.04|0.25||||||||0.25|-0.04|
72491950|NCT03016325|144512369|SUPERIORITY|Part II-Japan (low dose), clinically relevant hypotension - relative difference|Relative difference from placebo|0.33|||||TWO_SIDED|95.0|-0.17|0.78||||||||0.78|-0.17|
72491951|NCT03016325|144512369|SUPERIORITY|Part II-Japan (low dose), confirmed SBP \< 90 mmHg - relative difference|Relative difference from placebo|0.33|||||TWO_SIDED|95.0|-0.17|0.78||||||||0.78|-0.17|
72569378|NCT00444457|144669743|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|-0.2|||||TWO_SIDED|95.0|-2.14|1.73|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Common serotypes - serotype 14||1.73|-2.14|
72569379|NCT00444457|144669743|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|0.3|||||TWO_SIDED|95.0|-1.69|2.39|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Common serotypes - serotype 14||2.39|-1.69|
72491952|NCT03016325|144512369|SUPERIORITY|Part II-Japan (high dose), clinically relevant hypotension - relative difference|Relative difference from placebo|0.5|||||TWO_SIDED|95.0|-0.04|0.88||||||||0.88|-0.04|
72491953|NCT03016325|144512369|SUPERIORITY|Part II-Japan (high dose), confirmed SBP \< 90 mmHg - relative difference|Relative difference from placebo|0.5|||||TWO_SIDED|95.0|-0.04|0.88||||||||0.88|-0.04|
72491954|NCT03016325|144512372|SUPERIORITY|Part I, symptoms of hypotension - relative risk|Relative risk from placebo|2.94|||||TWO_SIDED|95.0|0.31|75.47||||||||75.47|0.31|
72491955|NCT03016325|144512372|SUPERIORITY|Part I, symptoms of hypotension - relative difference|Relative difference from placebo|0.04|||||TWO_SIDED|95.0|-0.06|0.15||||||||0.15|-0.06|
72569380|NCT00444457|144669743|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|0.5|||||TWO_SIDED|95.0|-1.46|2.59|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Common serotypes - serotype 14||2.59|-1.46|
72491956|NCT03016325|144512372|SUPERIORITY|Part II (low dose), symptoms of hypotension - relative risk|Relative risk from placebo|2.0|||||TWO_SIDED|95.0|0.18|54.35||||||||54.35|0.18|
72491957|NCT03016325|144512372|SUPERIORITY|Part II (low dose), symptoms of hypotension - relative difference|Relative difference from placebo|0.01|||||TWO_SIDED|95.0|-0.05|0.09||||||||0.09|-0.05|
72491958|NCT03016325|144512372|SUPERIORITY|Part II (high dose), symptoms of hypotension - relative risk|Relative risk from placebo|5.92|||||TWO_SIDED|95.0|0.91|149.72||||||||149.72|0.91|
72491959|NCT03016325|144512372|SUPERIORITY|Part II (high dose), symptoms of hypotension - relative difference|Relative difference from placebo|0.07|||||TWO_SIDED|95.0|-0.01|0.16||||||||0.16|-0.01|
72491960|NCT03016325|144512373|SUPERIORITY|Part I, confirmed SBP \< 90 mmHg - relative risk|Relative risk from placebo|3.27|||||TWO_SIDED|95.0|1.01|14.66||||||||14.66|1.01|
72569381|NCT00444457|144669743|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|-5.5|||||TWO_SIDED|95.0|-11.17|0.2|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Common serotypes - serotype 18C||0.20|-11.17|
72624804|NCT01346592|144778966|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (B strain)|1.45|||||TWO_SIDED|95.0|0.53|3.94||||||At risk subjects.||3.94|0.53|
72624805|NCT01346592|144778966|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (H1N1 strain)|2.24|||||TWO_SIDED|95.0|1.48|3.39||||||No risk subjects||3.39|1.48|
72491961|NCT03016325|144512373|SUPERIORITY|Part I, confirmed SBP \< 90 mmHg - relative difference|Relative difference from placebo|0.14|||||TWO_SIDED|95.0|0.0|0.29||||||||0.29|0.00|
72491962|NCT03016325|144512373|SUPERIORITY|Part II (low dose), confirmed SBP \< 90 mmHg - relative risk|Relative risk from placebo|1.15|||||TWO_SIDED|95.0|0.58|2.43||||||||2.43|0.58|
72491963|NCT03016325|144512373|SUPERIORITY|Part II (low dose), confirmed SBP \< 90 mmHg - relative difference|Relative difference from placebo|0.03|||||TWO_SIDED|95.0|-0.11|0.16||||||||0.16|-0.11|
72491964|NCT03016325|144512373|SUPERIORITY|Part II (high dose), confirmed SBP \< 90 mmHg - relative risk|Relative risk from placebo|1.59|||||TWO_SIDED|95.0|0.87|3.21||||||||3.21|0.87|
72491965|NCT03016325|144512373|SUPERIORITY|Part II (high dose), confirmed SBP \< 90 mmHg - relative difference|Relative difference from placebo|0.11|||||TWO_SIDED|95.0|-0.04|0.25||||||||0.25|-0.04|
72491966|NCT03016325|144512373|SUPERIORITY|Part II-Japan (low dose), confirmed SBP \< 90 mmHg - relative difference|Relative difference from placebo|0.33|||||TWO_SIDED|95.0|-0.17|0.78||||||||0.78|-0.17|
72491967|NCT03016325|144512373|SUPERIORITY|Part II-Japan (high dose), confirmed SBP \< 90 mmHg - relative difference|Relative difference from placebo|0.5|||||TWO_SIDED|95.0|-0.04|0.88||||||||0.88|-0.04|
72491968|NCT00814775|144512401|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.14||||0.72|TWO_SIDED|95.0|0.55|2.37|||Regression, Cox||CTrach vs. Fastrach|||2.37|0.55|0.72
72491969|NCT00814775|144512402|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.76||||0.45|TWO_SIDED|95.0|0.38|1.54|||Regression, Cox||CTrach vs. Fastrach|||1.54|0.38|0.45
72491970|NCT01902290|144512407|SUPERIORITY||Difference|-0.05||||0.5219|TWO_SIDED|95.0|-0.203|0.103|||Mixed-effect model|The model included fixed effects of treatment group, time, interaction of treatment group by time, stratification variables, and baseline ACQ score.|Difference = Brodalumab - Placebo|||0.103|-0.203|0.5219
72491971|NCT01902290|144512408|SUPERIORITY||Rate Ratio|1.41||||0.102|TWO_SIDED|95.0|0.93|2.12|||Generalized linear model|Generalized linear model under a negative binomial distribution assumption adjusting for stratification factors.|Rate ratio = Brodalumab : Placebo|||2.12|0.93|0.102
72491972|NCT01902290|144512409|SUPERIORITY||Difference|-0.038||||0.6632|TWO_SIDED|95.0|-0.21|0.134|||Mixed-effect model|The model included fixed effects of treatment group, time, interaction of treatment group by time, stratification factors, and baseline ACQ score.|Difference = Brodalumab - Placebo|||0.134|-0.210|0.6632
72517657|NCT02259127|144564809|NON_INFERIORITY|"\>=14kg cohort: Non-inferiority margin 10% in total population and 12% in ODYSSEY A/ODYSSEY B.~\<14kg cohort: power for efficacy was not prespecified for this cohort."|Risk Difference (RD)|-0.08|||=|0.004|TWO_SIDED|95.0|-0.14|-0.03|||Bootstrap method||The probability of having virological or clinical treatment failure by 96 weeks (primary endpoint) was estimated using Kaplan-Meier curves adjusted for stratification factors.|"Statistical Analysis Title: Primary: Diff in adj. KM estimates (\>=14kg)~Number of subjects included in analysis: 707~Analysis specification: Pre-specified"||-0.03|-0.14|= 0.004
72517658|NCT02259127|144564809|NON_INFERIORITY|"\>=14kg cohort: Non-inferiority margin 10% in total population and 12% in ODYSSEY A/ODYSSEY B.~\<14kg cohort: power for efficacy was not prespecified for this cohort."|Risk Difference (RD)|-0.18|||=|0.057|TWO_SIDED|95.0|-0.36|0.02|||Bootstrap method||The probability of having virological or clinical treatment failure by 96 weeks (primary endpoint) was estimated using Kaplan-Meier curves adjusted for trial cohort (ODYSSEY A or ODYSSEY B)|"Statistical Analysis Title: Diff in adj. KM estimates (Frequentist \<14kg)~Number of subjects included in analysis: 85~Analysis Specification: Pre-specified"||0.02|-0.36|=0.057
72569382|NCT00444457|144669743|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|-10.0|||||TWO_SIDED|95.0|-15.31|-4.7|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Common serotypes - serotype 18C||-4.70|-15.31|
72569383|NCT00444457|144669743|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|-4.5|||||TWO_SIDED|95.0|-9.55|0.46|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Common serotypes - serotype 18C||0.46|-9.55|
72569384|NCT00444457|144669743|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|-0.8|||||TWO_SIDED|95.0|-4.23|2.52|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Common serotypes - serotype 19F||2.52|-4.23|
72569385|NCT00444457|144669743|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|-3.3|||||TWO_SIDED|95.0|-6.35|-0.4|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Common serotypes - serotype 19F||-0.40|-6.35|
72569386|NCT00444457|144669743|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|-2.4|||||TWO_SIDED|95.0|-5.44|0.33|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Common serotypes - serotype 19F||0.33|-5.44|
72569387|NCT00444457|144669743|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|0.5|||||TWO_SIDED|95.0|-3.67|4.8|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Common serotypes - serotype 23F||4.80|-3.67|
72569388|NCT00444457|144669743|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|1.9|||||TWO_SIDED|95.0|-2.38|6.28|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Common serotypes - serotype 23F||6.28|-2.38|
72569389|NCT00444457|144669743|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|1.4|||||TWO_SIDED|95.0|-3.06|5.82|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Common serotypes - serotype 23F||5.82|-3.06|
72569390|NCT00444457|144669743|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|0.8|||||TWO_SIDED|95.0|-3.34|5.08|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Additional serotypes - serotype 1||5.08|-3.34|
72491973|NCT01902290|144512410|SUPERIORITY||Rate Ratio|1.45||||0.096|TWO_SIDED|95.0|0.94|2.24|||Generalized linear model|Generalized linear model under a negative binomial distribution assumption adjusting for stratification factors.|Rate ratio = Brodalumab : Placebo|||2.24|0.94|0.096
72491974|NCT01902290|144512411|SUPERIORITY||Difference|-0.046||||0.329|TWO_SIDED|95.0|-0.137|0.046|||Mixed-effect model|The model included fixed effects of treatment group, time, interaction of treatment group by time, stratification variables, and baseline score.|Difference = Brodalumab - Placebo|||0.046|-0.137|0.3290
72491975|NCT01902290|144512412|SUPERIORITY||Difference|0.03||||0.4549||95.0|-0.049|0.109|||Mixed-effect model|Model includes treatment, time, stratification factors, treatment by time and baseline value of age, gender, pooled race group, height and FEV1.|Difference = Brodalumab - Placebo|||0.109|-0.049|0.4549
72491976|NCT01902290|144512413|SUPERIORITY||Difference|0.128||||0.6317||95.0|-0.396|0.653|||Mixed-effect model|The model included fixed effects of treatment group, time, interaction of treatment group by time, stratification variables, and baseline value.|Difference = Brodalumab - Placebo|||0.653|-0.396|0.6317
72491977|NCT01902290|144512414|SUPERIORITY||Hazard Ratio (HR)|1.277||||0.238|TWO_SIDED|95.0|0.843|1.936|||Log Rank|Log rank test stratified for baseline stratification factors.||||1.936|0.843|0.238
72491978|NCT01902290|144512415|SUPERIORITY||Odds Ratio (OR)|1.25||||0.351||95.0|0.78|2.01|||Regression, Logistic|Logistic regression adjusted for stratification factors.||||2.01|0.78|0.351
72491979|NCT01902290|144512416|SUPERIORITY||Difference|-0.001||||0.987||95.0|-0.174|0.171|||Mixed-effects model|The model included fixed effects of treatment group, time, interaction of treatment group by time, stratification variables, and baseline AQLQ score.|Difference = Brodalumab - Placebo|||0.171|-0.174|0.9870
72491980|NCT01902290|144512417|SUPERIORITY||Difference|0.635||||0.9053|TWO_SIDED|95.0|-9.82|11.089|||Mixed-effect model|Model includes treatment, time, stratification factors, treatment by time and baseline value of age, gender, pooled race group, height and AM PEFR.|Difference = Brodalumab - Placebo|Analysis of morning peak flow||11.089|-9.820|0.9053
72491981|NCT01902290|144512417|SUPERIORITY||Difference|5.92||||0.2661|TWO_SIDED|95.0|-4.515|16.354|||Mixed-effects model|Model includes treatment, time, stratification factors, treatment by time and baseline value of age, gender, pooled race group, height and PM PEFR.|Difference = Brodalumab - Placebo|Analysis of evening peak flow||16.354|-4.515|0.2661
72491982|NCT01902290|144512418|SUPERIORITY||Difference|-4.021||||0.0871|TWO_SIDED|95.0|-8.627|0.586|||Mixed-effect model|Model includes treatment, time, stratification factors, treatment by time and baseline value of age, gender, race group, height and PEFR variation.|Difference = Brodalumab - Placebo|||0.586|-8.627|0.0871
72491983|NCT01618214|144512438|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was considered confirmed if the upper bound of the two-sided 95% confidence interval was below or equal to 0.4%.|Mean Difference (Final Values)|-0.02|STANDARD_DEVIATION|0.08||||95.0|-0.19|0.14|||Regression, Linear|||FAS||0.14|-0.19|
72491984|NCT01890642|144512443|SUPERIORITY_OR_OTHER|||||||0.01|TWO_SIDED||||||Kruskal-Wallis|||||||0.01
72517659|NCT02259127|144564809|NON_INFERIORITY|Bayesian estimation was used for the primary analysis of the difference in treatment failure by 96 weeks by arm in \<14kg cohort. An informative prior distribution was used based on the treatment effect observed in \>=14kg cohort, with relative weight defined by clinical opinion, solicited prior to the main trial results.|Risk Difference (RD)|-0.1||||0.02|TWO_SIDED|95.0|-0.19|-0.02|||Bootstrap method||The probability of having virological or clinical treatment failure by 96 weeks (primary endpoint) was estimated using Kaplan-Meier curves adjusted for trial cohort (ODYSSEY A or ODYSSEY B)|"Statistical Analysis Title: Primary: diff in adj. KM estimates (Bayesian \<14kg)~Number of subjects included in analysis: 85~Analysis Specification: Pre-specified"||-0.02|-0.19|0.02
72517660|NCT02259127|144564809|NON_INFERIORITY|"\>=14kg cohort: Non-inferiority margin 10% in total population and 12% in ODYSSEY A/ODYSSEY B.~\<14kg cohort: power for efficacy was not prespecified for this cohort."|Risk Difference (RD)|-0.12||||0.003|TWO_SIDED|95.0|-0.21|-0.04|||Bootstrap method||The probability of having virological or clinical treatment failure by 96 weeks (primary endpoint) was estimated using Kaplan-Meier curves adjusted for stratification factors.|"Statistical Analysis Title: Diff in adj. KM estimates (ODYSSEY A\>=14kg)~Number of subjects included in analysis: 311~Analysis Specification: Pre-specified"||-0.04|-0.21|0.003
72517661|NCT02259127|144564809|NON_INFERIORITY|"\>=14kg cohort: Non-inferiority margin 10% in total population and 12% in ODYSSEY A/ODYSSEY B.~\<14kg cohort: power for efficacy was not prespecified for this cohort."|Risk Difference (RD)|-0.05||||0.22|TWO_SIDED|95.0|-0.12|0.03|||Bootstrap method||The probability of having virological or clinical treatment failure by 96 weeks (primary endpoint) was estimated using Kaplan-Meier curves adjusted for stratification factors.|"Statistical Analysis Title: Diff in adj. KM estimates (ODYSSEY B \>=14kg)~Number of subjects included in analysis: 396~Analysis Specification: Pre-specified"||0.03|-0.12|0.22
72517662|NCT02259127|144564810|SUPERIORITY||Risk Difference (RD)|5.0|||=|0.1377|TWO_SIDED|95.0|-1.0|11.0|||Regression, Logistic|||"Statistical Analysis Title: Adjusted Difference (\>=14kg)~Number of subjects included in analysis: 665~Analysis Specification: Pre-specified"||11|-1|= 0.1377
72517663|NCT02259127|144564810|SUPERIORITY||Risk Difference (RD)|-1.0|||=|0.8895|TWO_SIDED|95.0|-10.0|8.0|||Regression, Logistic|||"Statistical Analysis Title: Adjusted difference (ODYSSEY A \>=14kg)~Number of subjects included in analysis: 286~Analysis Specification: Pre-specified"||8|-10|= 0.8895
72517664|NCT02259127|144564810|SUPERIORITY||Risk Difference (RD)|9.0|||=|0.0435|TWO_SIDED|95.0|0.4|17.0|||Regression, Logistic|||"Statistical Analysis Title: Adjusted Difference (ODYSSEY B \>=14kg)~Number of subjects included in analysis: 381~Analysis Specification: Pre-specified"||17|0.4|=0.0435
72517665|NCT02259127|144564810|SUPERIORITY||Risk Difference (RD)|26.0||||0.021|TWO_SIDED|95.0|6.0|47.0|||Regression, Logistic|||||47|6|0.021
72517666|NCT02259127|144564811|SUPERIORITY||Risk Difference (RD)|3.0|||=|0.2256|TWO_SIDED|95.0|-2.0|8.0|||Regression, Logistic|||"Statistical Analysis Title: Adjusted Difference (\>=14kg)~Number of subjects included in analysis: 670~Analysis Specification: Pre-specified"||8|-2|= 0.2256
72624806|NCT01346592|144778966|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (H3N2 strain)|1.76|||||TWO_SIDED|95.0|1.26|2.46||||||No risk subjects.||2.46|1.26|
72491985|NCT01890642|144512444|SUPERIORITY_OR_OTHER|||||||0.8|TWO_SIDED||||||Kruskal-Wallis|||||||0.80
72491986|NCT01890642|144512445|SUPERIORITY_OR_OTHER|||||||0.004|TWO_SIDED||||||Kruskal-Wallis|||||||0.004
72517667|NCT02259127|144564811|SUPERIORITY||Risk Difference (RD)|0.0|||=|0.9536|TWO_SIDED|95.0|-8.0|7.0|||Regression, Logistic|||"Statistical Analysis Title: Adjusted Difference (ODYSSEY A \>=14kg)~Number of subjects included in analysis: 286~Analysis Specification: Pre-specified"||7|-8|= 0.9536
72517668|NCT02259127|144564811|SUPERIORITY||Risk Difference (RD)|6.0|||=|0.1104|TWO_SIDED|95.0|-1.0|12.0|||Regression, Logistic|||"Statistical Analysis Title: Adjusted Difference (ODYSSEY B \>=14kg)~Number of subjects included in analysis: 384~Analysis Specification: Pre-specified"||12|-1|= 0.1104
72517669|NCT02259127|144564811|SUPERIORITY||Risk Difference (RD)|19.0||||0.038|TWO_SIDED|95.0|2.0|37.0|||Regression, Logistic|||||37|2|0.038
72517670|NCT02259127|144564812|SUPERIORITY||Mean Difference (Final Values)|35.0|||=|0.144|TWO_SIDED|95.0|-12.0|82.0|||Regression, Linear|||"Statistical Analysis Title: Adjusted Difference (\>=14kg)~Statistical analysis description: Linear regression of CD4 at week 96, adjusted for randomised arm, baseline CD4 and stratification factors. Presenting mean difference between arms.~Number of subjects included in analysis: 707~Analysis Specification: Pre-specified"||82|-12|= 0.144
72624807|NCT01346592|144778966|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (B strain)|1.59|||||TWO_SIDED|95.0|1.24|2.04||||||No risk subjects||2.04|1.24|
72491987|NCT01890642|144512446|SUPERIORITY_OR_OTHER|||||||0.0001|TWO_SIDED||||||Kruskal-Wallis|||||||0.0001
72491988|NCT01890642|144512447|SUPERIORITY_OR_OTHER|||||||0.37|TWO_SIDED||||||Kruskal-Wallis|||||||0.37
72491989|NCT04703075|144512448|SUPERIORITY||Risk Difference (RD)|5.5||||0.07|TWO_SIDED||||||Chi-squared, Corrected|||||||0.07
72491990|NCT01508702|144512451|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.28|||<|0.0001|TWO_SIDED|95.0|0.19|0.37|||Cochran-Mantel-Haenszel|||||0.37|0.19|<0.0001
72517671|NCT02259127|144564812|SUPERIORITY||Mean Difference (Final Values)|44.0||||0.185|TWO_SIDED|95.0|-21.0|109.0|||Regression, Linear|||"Statistical Analysis Title: Adjusted Difference (ODYSSEY A \>=14kg)~Statistical analysis description: Linear regression of CD4 at week 96, adjusting for randomised arm, baseline CD4 and stratification factors. Presenting mean difference between arms.~Number of subjects included in analysis: 311~Analysis Specification: Pre-specified"||109|-21|0.185
72517672|NCT02259127|144564812|SUPERIORITY||Mean Difference (Final Values)|27.0|||=|0.427|TWO_SIDED|95.0|-39.0|93.0|||Regression, Linear|||"Statistical Analysis Title: Adjusted Difference (ODYSSEY B \>=14kg)~Statistical analysis description: Linear regression of CD4 at week 96, adjusting for randomised arm, baseline CD4 and stratification factors. Presenting mean difference between arms.~Number of subjects included in analysis: 396~Analysis Specification: Pre-specified"||93|-39|= 0.427
72517673|NCT02259127|144564812|SUPERIORITY||Median Difference (Final Values)|30.0||||0.86|TWO_SIDED|95.0|-308.0|368.0|||Regression, Linear|||||368|-308|0.86
72517674|NCT02259127|144564813|SUPERIORITY||Mean Difference (Final Values)|-15.1|||<|0.001|TWO_SIDED|95.0|-19.0|-11.1|||Regression, Linear|||"Statistical Analysis Title: Adjusted Difference (\>=14kg)~Statistical analysis description: Linear regression of total cholesterol at week 96, adjusting for randomised arm, baseline total cholesterol and stratification factors. Presenting mean difference between arms.~Number of subjects included in analysis: 707~Analysis Specification: Pre-specified"||-11.1|-19|< 0.001
72517675|NCT02259127|144564813|SUPERIORITY||Mean Difference (Final Values)|-24.4|||=|0.0032|TWO_SIDED|95.0|-40.3|-8.5|||Regression, Linear|||"Statistical Analysis Title: Adjusted Difference (\<14kg)~Statistical analysis description: Linear regression of total cholesterol at week 96, adjusting for randomised arm, baseline total cholesterol and stratification factors. Presenting mean difference between arms.~Number of subjects included in analysis: 85~Analysis Specification: Pre-specified"||-8.5|-40.3|= 0.0032
72517676|NCT02259127|144564813|SUPERIORITY||Mean Difference (Final Values)|-17.5|||<|0.001|TWO_SIDED|95.0|-23.9|-11.1|||Regression, Linear|||"Statistical Analysis Title: Adjusted Difference (ODYSSEY A \>=14kg)~Statistical analysis description: Linear regression of total cholesterol at week 96, adjusting for randomised arm, baseline total cholesterol and stratification factors. Presenting mean difference between arms.~Number of subjects included in analysis: 311~Analysis Specification: Pre-specified"||-11.1|-23.9|< 0.001
72517677|NCT02259127|144564813|SUPERIORITY||Mean Difference (Final Values)|-13.4|||<|0.001|TWO_SIDED|95.0|-18.5|-8.4|||Regression, Linear|||"Statistical Analysis Title: Adjusted Difference (ODYSSEY B \>=14kg)~Statistical analysis description: Linear regression of total cholesterol at week 96, adjusting for randomised arm, baseline total cholesterol and stratification factors. Presenting mean difference between arms.~Number of subjects included in analysis: 396~Analysis Specification: Pre-specified"||-8.4|-18.5|< 0.001
72517678|NCT02259127|144564814|SUPERIORITY||Hazard Ratio (HR)|0.87|||=|0.53|TWO_SIDED|95.0|0.55|1.36|||Regression, Cox|||"Statistical Analysis Title: Adjusted time to first event (\>=14kg)~Number of subjects included in analysis: 707~Analysis Specification: Pre-specified"||1.36|0.55|= 0.53
72517679|NCT02259127|144564814|SUPERIORITY||Hazard Ratio (HR)|1.08|||=|0.86|TWO_SIDED|95.0|0.47|2.49|||Regression, Cox|||"Statistical Analysis Title: Adjusted time to first event (\<14kg)~Number of subjects included in analysis: 85~Analysis Specification: Pre-specified"||2.49|0.47|= 0.86
72517680|NCT02259127|144564814|SUPERIORITY||Hazard Ratio (HR)|0.83|||=|0.52|TWO_SIDED|95.0|0.48|1.46|||Regression, Cox|||"Statistical Analysis Title: Adjusted time to first event (ODYSSEY A \>=14kg)~Number of subjects included in analysis: 311~Analysis Specification: Pre-specified"||1.46|0.48|= 0.52
72517681|NCT02259127|144564814|SUPERIORITY||Hazard Ratio (HR)|0.93|||=|0.86|TWO_SIDED|95.0|0.42|2.04|||Regression, Cox|||"Statistical Analysis Title: Adjusted time to first event (ODYSSEY B \>=14kg)~Number of subjects included in analysis: 396~Analysis Specification: Pre-specified"||2.04|0.42|= 0.86
72517682|NCT02259127|144564815|SUPERIORITY||Hazard Ratio (HR)|0.83|||=|0.24|TWO_SIDED|95.0|0.61|1.13|||Regression, Cox|||"Statistical Analysis Title: Adjusted time to first event (\>=14kg)~Number of subjects included in analysis: 707~Analysis Specification: Pre-specified"||1.13|0.61|= 0.24
72517683|NCT02259127|144564815|SUPERIORITY||Hazard Ratio (HR)|0.93|||=|0.83|TWO_SIDED|95.0|0.5|1.74|||Regression, Cox|||"Statistical Analysis Title: Adjusted time to first event (\<14kg)~Number of subjects included in analysis: 85~Analysis Specification: Pre-specified"||1.74|0.5|= 0.83
72517684|NCT02259127|144564815|SUPERIORITY||Hazard Ratio (HR)|1.13|||=|0.57|TWO_SIDED|95.0|0.75|1.7|||Regression, Cox|||"Statistical Analysis Title: Adjusted time to first event (ODYSSEY A \>=14kg)~Number of subjects included in analysis: 311~Analysis Specification: Pre-specified"||1.7|0.75|= 0.57
72517685|NCT02259127|144564815|SUPERIORITY||Hazard Ratio (HR)|0.54|||=|0.01|TWO_SIDED|95.0|0.33|0.88|||Regression, Cox|||"Statistical Analysis Title: Adjusted time to first event (ODYSSEY B \>=14kg)~Number of subjects included in analysis: 396~Analysis Specification: Pre-specified"||0.88|0.33|= 0.01
72517686|NCT02259127|144564816|SUPERIORITY||Hazard Ratio (HR)|0.29|||=|0.01|TWO_SIDED|95.0|0.11|0.77|||Regression, Cox|||"Statistical Analysis Title: Adjusted time to first event (\>=14kg)~Number of subjects included in analysis: 707~Analysis Specification: Pre-specified"||0.77|0.11|= 0.01
72517687|NCT02259127|144564816|SUPERIORITY||Hazard Ratio (HR)|0.35|||=|0.13|TWO_SIDED|95.0|0.09|1.33|||Regression, Cox|||"Statistical Analysis Title: Adjusted time to first event (ODYSSEY A \>=14kg)~Number of subjects included in analysis: 311~Analysis Specification: Pre-specified"||1.33|0.09|= 0.13
72517688|NCT02259127|144564816|SUPERIORITY||Hazard Ratio (HR)|0.22||||0.055|TWO_SIDED|95.0|0.05|1.03|||Regression, Cox|||"Statistical Analysis Title: Adjusted time to first event (ODYSSEY B \>=14kg)~Number of subjects included in analysis: 396~Analysis Specification: Pre-specified"||1.03|0.05|0.055
72517689|NCT02259127|144564817|NON_INFERIORITY|"\>=14kg cohort: Non-inferiority margin 10% in total population and 12% in ODYSSEY A/ODYSSEY B.~\<14kg cohort: power for efficacy was not prespecified for this cohort."|Risk Difference (RD)|-0.06|||=|0.003|TWO_SIDED|95.0|-0.1|-0.02|||Bootstrap method||The probability of having virological or clinical treatment failure by 48 weeks was estimated using Kaplan-Meier curves adjusted for stratification factors.|"Statistical Analysis Title: Diff in adj. KM estimates (\>=14kg)~Statistical analysis description: Difference in adjusted (for stratification factors) Kaplan-Meier survival function estimates at 48 weeks after randomisation.~Number of subjects included in analysis: 707~Analysis Specification: Pre-specified"||-0.02|-0.1|= 0.003
72624808|NCT01346592|144778966|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (H1N1 strain)|2.48|||||TWO_SIDED|95.0|0.34|18.0||||||At risk subjects.||18|0.34|
72624809|NCT01346592|144778966|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (H3N2 strain)|1.98|||||TWO_SIDED|95.0|0.49|7.92||||||At risk subjects.||7.92|0.49|
72517690|NCT02259127|144564817|NON_INFERIORITY|"\>=14kg cohort: Non-inferiority margin 10% in total population and 12% in ODYSSEY A/ODYSSEY B.~\<14kg cohort: power for efficacy was not prespecified for this cohort."|Risk Difference (RD)|-0.07|||=|0.035|TWO_SIDED|95.0|-0.13|-0.01|||Bootstrap method||The probability of having virological or clinical treatment failure by 48 weeks was estimated using Kaplan-Meier curves adjusted for stratification factors.|"Statistical Analysis Title: Diff in adj. KM estimates (ODYSSEY A \>=14kg)~Statistical analysis description: Difference in adjusted (for stratification factors) Kaplan-Meier survival function estimates at 48 weeks after randomisation.~Number of subjects included in analysis: 311~Analysis Specification: Pre-specified"||-0.01|-0.13|= 0.035
72517691|NCT02259127|144564817|NON_INFERIORITY|"\>=14kg cohort: Non-inferiority margin 10% in total population and 12% in ODYSSEY A/ODYSSEY B.~\<14kg cohort: power for efficacy was not prespecified for this cohort."|Risk Difference (RD)|-0.05|||=|0.039|TWO_SIDED|95.0|-0.11|-0.004|||Bootstrap method||The probability of having virological or clinical treatment failure by 48 weeks was estimated using Kaplan-Meier curves adjusted for stratification factors.|"Statistical Analysis Title: Diff in adj. KM estimates (ODYSSEY B \>=14kg)~Statistical analysis description: Difference in adjusted (for stratification factors) Kaplan-Meier survival function estimates at 48 weeks after randomisation.~Number of subjects included in analysis: 396~Analysis Specification: Pre-specified"||-0.004|-0.11|= 0.039
72517692|NCT02259127|144564817|NON_INFERIORITY|"\>=14kg cohort: Non-inferiority margin 10% in total population and 12% in ODYSSEY A/ODYSSEY B.~\<14kg cohort: power for efficacy was not prespecified for this cohort."|Risk Difference (RD)|-0.18||||0.057|TWO_SIDED|95.0|-0.36|0.02|||Other [Bootstrap method]|||||0.02|-0.36|0.057
72569391|NCT00444457|144669743|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|-2.6|||||TWO_SIDED|95.0|-6.39|1.18|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Additional serotypes - serotype 1||1.18|-6.39|
72517693|NCT02259127|144564818|NON_INFERIORITY|"\>=14kg cohort: Non-inferiority margin 10% in total population and 12% in ODYSSEY A/ODYSSEY B.~\<14kg cohort: power for efficacy was not prespecified for this cohort."|Risk Difference (RD)|-0.09|||=|0.003|TWO_SIDED|95.0|-0.16|-0.04|||Bootstrap method||The probability of having virological or clinical treatment failure by 144 weeks was estimated using Kaplan-Meier curves adjusted for stratification factors.|"Statistical Analysis Title: Diff in adj. KM estimates (\>=14kg)~Statistical analysis description: Difference in adjusted (for stratification factors) Kaplan-Meier survival function estimates at 144 weeks after randomisation.~Number of subjects included in analysis: 707~Analysis Specification: Pre-specified"||-0.04|-0.16|= 0.003
72517694|NCT02259127|144564818|NON_INFERIORITY|"\>=14kg cohort: Non-inferiority margin 10% in total population and 12% in ODYSSEY A/ODYSSEY B.~\<14kg cohort: power for efficacy was not prespecified for this cohort."|Risk Difference (RD)|-0.12|||=|0.009|TWO_SIDED|95.0|-0.21|-0.03|||Bootstrap method||The probability of having virological or clinical treatment failure by 144 weeks was estimated using Kaplan-Meier curves adjusted for stratification factors.|"Statistical Analysis Title: Diff in adj. KM estimates (ODYSSEY A \>=14kg)~Statistical analysis description: Difference in adjusted (for stratification factors) Kaplan-Meier survival function estimates at 144 weeks after randomisation.~Number of subjects included in analysis: 311~Analysis Specification: Pre-specified"||-0.03|-0.21|= 0.009
72569392|NCT00444457|144669743|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|-3.4|||||TWO_SIDED|95.0|-7.45|0.46|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Additional serotypes - serotype 1||0.46|-7.45|
72569393|NCT00444457|144669743|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|1.6|||||TWO_SIDED|95.0|-5.2|8.55|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Additional serotypes - serotype 3||8.55|-5.20|
72569394|NCT00444457|144669743|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|-4.8|||||TWO_SIDED|95.0|-11.79|2.16|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Additional serotypes - serotype 3||2.16|-11.79|
72569395|NCT00444457|144669743|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|-6.5|||||TWO_SIDED|95.0|-13.51|0.54|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Additional serotypes - serotype 3||0.54|-13.51|
72569396|NCT00444457|144669743|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|3.1|||||TWO_SIDED|95.0|-0.84|7.13|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Additional serotypes - serotype 5||7.13|-0.84|
72569397|NCT00444457|144669743|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|0.5|||||TWO_SIDED|95.0|-3.14|4.11|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Additional serotypes - serotype 5||4.11|-3.14|
72569398|NCT00444457|144669743|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|-2.6|||||TWO_SIDED|95.0|-6.72|1.4|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Additional serotypes - serotype 5||1.40|-6.72|
72569399|NCT00444457|144669743|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|0.9|||||TWO_SIDED|95.0|-0.87|3.02|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Additional serotypes - serotype 6A||3.02|-0.87|
72569400|NCT00444457|144669743|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|0.0|||||TWO_SIDED|95.0|-1.62|1.71|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Additional serotypes - serotype 6A||1.71|-1.62|
72569401|NCT00444457|144669743|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|-0.9|||||TWO_SIDED|95.0|-3.0|0.92|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Additional serotypes - serotype 6A||0.92|-3.00|
72405139|NCT02272413|144317889|EQUIVALENCE|Additional analysis of the primary endpoint was performed for Japan according to a local protocol amendment Japan. For the submission in Japan, to conclude on equivalence, the 2-sided 95% CI for the ratio of best ORR between the treatments had to be entirely contained within the equivalence margins of 0.736 to 1.359.|Ratio of best ORR|0.855|||||TWO_SIDED|95.0|0.7543|0.97|||Log-binomial regression|||Analysis was based on a log-binomial regression model with subsequent transformation of the estimated parameter (ratio of best ORR) respective CIs to the ratio scale. The model included the following explanatory variables: treatment, sex (male versus female), smoking status (never smoked versus current/ex-smoker), NSCLC stage (recurrent versus Stage IV) and ethnicity (East Asian origin versus Non-East Asian).||0.9700|0.7543|
72405140|NCT02272413|144317890|OTHER||Risk Ratio (RR)|1.16|||||TWO_SIDED|95.0|0.99|1.37|||Score exact method|||At least 1 AE selected for comparability assessment, risk ratio X (BI 695502) versus Y (US-licensed Avastin®) was defined as (a/(a+b))/(c/(c+d)), where 'a' was the number of patients with TEAEs selected for comparability within treatment group X, 'a+b' was the total number of patients in treatment group X, 'c' was the number of patients with TEAEs selected for comparability within treatment group Y and 'c+d' was the total number of patients in treatment group Y.||1.37|0.99|
72491991|NCT02572752|144512456|SUPERIORITY_OR_OTHER||gMean Ratio|97.478|STANDARD_ERROR_OF_MEAN|11.57|<|0.0001|TWO_SIDED|90.0|94.545|100.502|||ANOVA||Relative bioavailability was estimated by the ratios of the gMean of nin Test treatment (T) divided by nin Reference treatment (R1 \& R2). Standard Error of the mean is actually the intra individual geometric coefficient variation (gCV).|An Analysis of variance (ANOVA) model was used on the logarithmic scale in order to compare the Test treatment vs. the Reference treatment (without differentiation between R1 and R2). This model included effects for 'sequence', 'subjects within sequences', 'period' and 'treatment'. For the two 1-sided t-test procedure, the effect 'subjects within sequences' was considered to be random, whereas the other effects were considered to be fixed||100.502|94.545|<0.0001
72491992|NCT02572752|144512457|SUPERIORITY_OR_OTHER||gMean Ratio|97.004|STANDARD_ERROR_OF_MEAN|20.77|<|0.0001|TWO_SIDED|90.0|90.948|103.463|||ANOVA||Relative bioavailability was estimated by the ratios of the gMean of nin Test treatment (T) divided by nin Reference treatment (R1 \& R2). Standard Error of the mean is actually the intra individual geometric coefficient variation (gCV).|An ANOVA model was used on the logarithmic scale in order to compare the Test treatment vs. the Reference treatment (without differentiation between R1 and R2). This model included effects for 'sequence', 'subjects within sequences', 'period' and 'treatment'. For the two 1-sided t-test procedure, the effect 'subjects within sequences' was considered to be random, whereas the other effects were considered to be fixed.||103.463|90.948|<0.0001
72491993|NCT02572752|144512458|SUPERIORITY_OR_OTHER||gMean Ratio|97.149|STANDARD_DEVIATION|11.4|<|0.0001|TWO_SIDED|90.0|94.223|100.166|||ANOVA||Relative bioavailability was estimated by the ratios of the gMean of nin Test treatment (T) divided by nin Reference treatment (R1 \& R2). Standard Error of the mean is actually the intra individual geometric coefficient variation (gCV).|An ANOVA model was used on the logarithmic scale in order to compare the Test treatment vs. the Reference treatment (without differentiation between R1 and R2). This model included effects for 'sequence', 'subjects within sequences', 'period' and 'treatment'. For the two 1-sided t-test procedure, the effect 'subjects within sequences' was considered to be random, whereas the other effects were considered to be fixed||100.166|94.223|<0.0001
72491994|NCT00853671|144512465|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Pearson Correlation|||||||<0.0001
72491995|NCT00853671|144512467|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Pearson Correlation|||Pearson Correlation||||<0.0001
72491996|NCT00507559|144512484|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Fisher Exact|||This is compared to a historical control group, in which 11.1% of subjects experienced one or more MAE within 30 days.||||<0.001
72491997|NCT00631748|144512493|SUPERIORITY_OR_OTHER||||||<|0.25|TWO_SIDED|95.0|||||ANCOVA|We compared TLFB at baseline and at end of study.||We used a repeated-measures ANCOVA to compare cocaine usage between the two groups. This incorporated the multiple administrations of the Timeline Followback measure.||||<0.25
72491998|NCT00631748|144512494|SUPERIORITY_OR_OTHER|||||||0.65||95.0|||||Regression, Cox|||End-of-trial abstinence was defined as a negative urine drug screen (for cocaine) for three consecutive weeks at the end of the study.||||.65
72517695|NCT02259127|144564818|NON_INFERIORITY|"\>=14kg cohort: Non-inferiority margin 10% in total population and 12% in ODYSSEY A/ODYSSEY B.~\<14kg cohort: power for efficacy was not prespecified for this cohort."|Risk Difference (RD)|-0.08|||=|0.079|TWO_SIDED|95.0|-0.16|0.01|||Bootstrap method||The probability of having virological or clinical treatment failure by 144 weeks was estimated using Kaplan-Meier curves adjusted for stratification factors.|"Statistical Analysis Title: Diff in adj. KM estimates (ODYSSEY B \>=14kg)~Statistical analysis description: Difference in adjusted (for stratification factors) Kaplan-Meier survival function estimates at 144 weeks after randomisation.~Number of subjects included in analysis: 396~Analysis Specification: Pre-specified"||0.01|-0.16|= 0.079
72517696|NCT02259127|144564819|SUPERIORITY||Hazard Ratio (HR)|1.0|||=|0.993|TWO_SIDED|95.0|0.38|2.68|||Regression, Cox|||"Statistical Analysis Title: Adjusted time to first event (\>=14kg)~Number of subjects included in analysis: 707~Analysis Specification: Pre-specified"||2.68|0.38|= 0.993
72491999|NCT00562588|144512527|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.067||||0.683||95.0|0.78|1.461|||Regression, Logistic|||The primary endpoint tele-mRS on day 90 was available in 527 of 543 treated patients (97.1%).||1.461|0.78|0.683
72492000|NCT00562588|144512528|SUPERIORITY_OR_OTHER|||||||0.607||95.0|||||ANCOVA|ANCOVA with factors for treatment, age, weight, baseline SBP, diabetes, previous stroke and baseline NIHSS||Early treatment initiation (immediately after the index event) with Aggrenox was compared to late initiation of Aggrenox after 7 days of treatment with ASA mono||||0.607
72492001|NCT00562588|144512529|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.725||||0.202||95.0|0.442|1.189|||Cox proportional hazards model|||Early treatment initiation (immediately after the index event) with Aggrenox was compared to late initiation of Aggrenox after 7 days of treatment with ASA mono||1.189|0.442|0.202
72492002|NCT00313209|144512539|SUPERIORITY_OR_OTHER||Mean Difference (Net)|49.0|STANDARD_ERROR_OF_MEAN|11.0|<|0.0001|TWO_SIDED|95.0|27.0|71.0||No adjustment of the significance level (0.05) was done as a hierarchical approach for hypotheses testing was used.|ANCOVA|Repeated measurements analysis (change from baseline over 24 weeks of treatment taking all post-randomization measurements into account).||||71|27|<0.0001
72405141|NCT02272413|144317890|OTHER||Risk Ratio (RR)|1.28|||||TWO_SIDED|95.0|0.88|1.88|||Score exact method|||Infusion reactions, risk ratio X (BI 695502) versus Y (US-licensed Avastin®) was defined as (a/(a+b))/(c/(c+d)), where 'a' was the number of patients with TEAEs selected for comparability within treatment group X, 'a+b' was the total number of patients in treatment group X, 'c' was the number of patients with TEAEs selected for comparability within treatment group Y and 'c+d' was the total number of patients in treatment group Y.||1.88|0.88|
72405142|NCT02272413|144317890|OTHER||Risk Ratio|1.2|||||TWO_SIDED|95.0|0.64|2.32|||Score exact method|||Thromboembolic events, risk ratio X (BI 695502) versus Y (US-licensed Avastin®) was defined as (a/(a+b))/(c/(c+d)), where 'a' was the number of patients with TEAEs selected for comparability within treatment group X, 'a+b' was the total number of patients in treatment group X, 'c' was the number of patients with TEAEs selected for comparability within treatment group Y and 'c+d' was the total number of patients in treatment group Y.||2.32|0.64|
72492003|NCT00313209|144512540|SUPERIORITY_OR_OTHER||Mean Difference (Net)|60.0|STANDARD_ERROR_OF_MEAN|11.0|<|0.0001|TWO_SIDED|95.0|38.0|82.0||No adjustment of the significance level (0.05) was done as a hierarchical approach for hypotheses testing was used.|ANCOVA|Repeated measurements analysis (change from baseline over 24 weeks of treatment taking all post-randomization measurements into account).||||82|38|<0.0001
72492004|NCT00313209|144512541|SUPERIORITY_OR_OTHER||Rate ratio|0.79|STANDARD_ERROR_OF_MEAN|0.12||0.1408|TWO_SIDED|95.0|0.58|1.08||No adjustment of the significance level (0.05) was done as a hierarchical approach for hypotheses testing was used.|Poisson regression|||||1.08|0.58|0.1408
72492005|NCT00313209|144512542|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.2||0.4654|TWO_SIDED|95.0|-0.2|0.4||No adjustment of the significance level (0.05) was done as a hierarchical approach for hypotheses testing was used.|ANCOVA|Repeated measurements analysis (change from baseline over 24 weeks of treatment taking all post-randomization measurements into account).||||0.4|-0.2|0.4654
72492006|NCT00313209|144512543|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.5|STANDARD_ERROR_OF_MEAN|0.9||0.5457|TWO_SIDED|95.0|-1.2|2.2||No adjustment of the significance level (0.05) was done as a hierarchical approach for hypotheses testing was used.|ANCOVA|Repeated measurements analysis (change from baseline over 24 weeks of treatment taking all post-randomization measurements into account).||||2.2|-1.2|0.5457
72492007|NCT01332357|144512544|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.96|||<|0.0001|TWO_SIDED|95.0|1.56|2.46||The unadjusted risk of experiencing a recurrent event associated with not initiating a controller medication at index event discharge|Regression, Cox|||||2.46|1.56|<0.0001
72492008|NCT01332357|144512544|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.79|||<|0.0001|TWO_SIDED|95.0|1.42|2.25||The adjusted risk of experiencing a recurrent event associated with not initiating a controller medication at index event discharge|Regression, Cox|Covariates included demographics, IP or ED index event, primary asthma diagnosis, Charlson score, and pre-index medication||||2.25|1.42|<0.0001
72492009|NCT01332357|144512544|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.008|||<|0.0001|TWO_SIDED|95.0|1.005|1.011||The risk of experiencing a recurrent event associated with not initiating a controller medication at index event discharge by time interaction|Regression, Cox|Evaluates the impact of each day treatment with a controller was delayed||||1.011|1.005|<0.0001
72492010|NCT03784079|144512649|OTHER||Emax|-1.937|||||TWO_SIDED|95.0|-2.484|-1.389||||||||-1.389|-2.484|
72492011|NCT03784079|144512649|OTHER||EC50|7.094|||||TWO_SIDED|95.0|0.585|13.602||||||||13.602|0.585|
72492012|NCT03784079|144512649|OTHER||s2e|0.137|||||TWO_SIDED|95.0|0.062|0.212||||||||0.212|0.062|
72492013|NCT03784079|144512650|OTHER||Emax|-1.929|||||TWO_SIDED|95.0|-2.479|-1.379||||||||-1.379|-2.479|
72492014|NCT03784079|144512650|OTHER||EC50|0.446|||||TWO_SIDED|95.0|0.03|0.861||||||||0.861|0.030|
72492015|NCT03784079|144512650|OTHER||s2e|0.139|||||TWO_SIDED|95.0|0.063|0.216||||||||0.216|0.063|
72492016|NCT03784079|144512651|OTHER||Emax|-1.926|||||TWO_SIDED|95.0|-2.498|-1.354||||||||-1.354|-2.498|
72492017|NCT03784079|144512651|OTHER||EC50|0.197|||||TWO_SIDED|95.0|0.007|0.386||||||||0.386|0.007|
72492018|NCT03784079|144512651|OTHER||s2e|0.144|||||TWO_SIDED|95.0|0.065|0.222||||||||0.222|0.065|
72492019|NCT04099251|144512665|SUPERIORITY||Hazard Ratio (HR)|0.42|||<|0.0001|TWO_SIDED|95.0|0.3|0.59|||Regression, Cox|||||0.59|0.30|< 0.0001
72492020|NCT05032157|144512677|SUPERIORITY||Mean Difference (Final Values)|-7.68|STANDARD_ERROR_OF_MEAN|1.136|<|0.001|TWO_SIDED|95.0|-9.91|-5.46|||Mixed Models Analysis||MMRM adjusting for treatment arm, geographical region, prior exposure to anti-IgE biologics, week, baseline score and both interaction of treatment by week and interaction of baseline score by week.|UAS7 at Week 12 (Scenario 1 with UAS7 as primary efficacy endpoint)||-5.46|-9.91|< 0.001
72492021|NCT05032157|144512678|SUPERIORITY||Mean Difference (Final Values)|-3.23|STANDARD_ERROR_OF_MEAN|0.545|<|0.001|TWO_SIDED|95.0|-4.29|-2.16|||Mixed Models Analysis||MMRM adjusting for treatment arm, geographical region, prior exposure to anti- IgE, biologics, week, baseline score, and both interaction of treatment by week and interaction of baseline score by week.|ISS7 at Week 12 (Scenario 2 with ISS7 and HSS7 as co-primary efficacy endpoints)||-2.16|-4.29|<0.001
72492022|NCT05032157|144512679|SUPERIORITY||Mean Difference (Final Values)|-4.47|STANDARD_ERROR_OF_MEAN|0.634|<|0.001|TWO_SIDED|95.0|-5.71|-3.23|||Mixed Models Analysis||MMRM adjusting for treatment arm, geographical region, prior exposure to anti- IgE biologics, week, baseline score and both interaction of treatment by week and interaction of baseline score by week.|HSS7 at Week 12 (Scenario 2 with ISS7 and HSS7 as co-primary efficacy endpoints)||-3.23|-5.71|< 0.001
72492023|NCT05032157|144512680|SUPERIORITY||Odds Ratio (OR)|3.84|||<|0.001|TWO_SIDED|95.0|2.39|6.18|||Regression, Logistic||Logistic regression adjusting for treatment arm, geographical region, prior exposure to anti-IgE biologics, and baseline UAS7 score.|Disease activity control (UAS7 =\< 6) at Week 12||6.18|2.39|< 0.001
72492024|NCT05032157|144512681|SUPERIORITY||Odds Ratio (OR)|5.78|||<|0.001|TWO_SIDED|95.0|2.83|11.78|||Regression, Logistic||Logistic regression adjusting for treatment arm, geographical region, prior exposure to anti-IgE biologics, and baseline UAS7 score.|Complete absence of hives and itch (UAS7 = 0) at Week 12||11.78|2.83|< 0.001
72492025|NCT05032157|144512682|SUPERIORITY||Odds Ratio (OR)|7.92|||<|0.001|TWO_SIDED|95.0|3.72|16.85|||Regression, Logistic||Logistic regression adjusting for treatment arm, geographical region, prior exposure to anti-IgE biologics, and baseline UAS7 score.|Early onset of disease activity control (UAS7 =\< 6) at Week 2||16.85|3.72|< 0.001
72517697|NCT02259127|144564819|SUPERIORITY||Hazard Ratio (HR)|0.5|||=|0.33|TWO_SIDED|95.0|0.13|2.0|||Regression, Cox|||"Statistical Analysis Title: Adjusted time to first event (\<14kg)~Number of subjects included in analysis: 85~Analysis Specification: Pre-specified"||2|0.13|= 0.33
72517698|NCT02259127|144564819|SUPERIORITY||Hazard Ratio (HR)|1.01|||=|0.991|TWO_SIDED|95.0|0.32|3.12|||Regression, Cox|||"Statistical Analysis Title: Adjusted time to first event (ODYSSEY A \>=14kg)~Number of subjects included in analysis: 311~Analysis Specification: Pre-specified"||3.12|0.32|= 0.991
72569402|NCT00444457|144669743|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|1.9|||||TWO_SIDED|95.0|-0.62|4.67|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Additional serotypes - serotype 7F||4.67|-0.62|
72569403|NCT00444457|144669743|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|-0.5|||||TWO_SIDED|95.0|-2.67|1.55|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Additional serotypes - serotype 7F||1.55|-2.67|
72569404|NCT00444457|144669743|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|-2.4|||||TWO_SIDED|95.0|-5.11|-0.01|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Additional serotypes - serotype 7F||-0.01|-5.11|
72517699|NCT02259127|144564819|SUPERIORITY||Hazard Ratio (HR)|1.0|||=|0.997|TWO_SIDED|95.0|0.14|7.13|||Regression, Cox|||"Statistical Analysis Title: Adjusted time to first event (ODYSSEY B \>=14kg)~Number of subjects included in analysis: 396~Analysis Specification: Pre-specified"||7.13|0.14|= 0.997
72517700|NCT02259127|144564820|NON_INFERIORITY|"\>=14kg cohort: Non-inferiority margin 10% in total population and 12% in ODYSSEY A/ODYSSEY B.~\<14kg cohort: power for efficacy was not prespecified for this cohort."|Risk Difference (RD)|-0.07|||=|0.015|TWO_SIDED|95.0|-0.12|-0.01|||Bootstrap method||The probability of having virological or clinical treatment failure by 96 weeks (per protocol analysis) was estimated using Kaplan-Meier curves adjusted for stratification factors.|"Statistical Analysis Title: Diff in adj. KM estimates (\>=14kg)~Statistical analysis description: Difference in adjusted (for stratification factors) Kaplan-Meier survival function estimates at 96 weeks after randomisation.~Number of subjects included in analysis: 677~Analysis Specification: Pre-specified"||-0.01|-0.12|= 0.015
72517701|NCT02259127|144564820|NON_INFERIORITY|"\>=14kg cohort: Non-inferiority margin 10% in total population and 12% in ODYSSEY A/ODYSSEY B.~\<14kg cohort: power for efficacy was not prespecified for this cohort."|Risk Difference (RD)|-0.172|||=|0.075|TWO_SIDED|95.0|-0.362|0.029|||Bootstrap method||The probability of having virological or clinical treatment failure by 96 weeks (per protocol analysis) was estimated using Kaplan-Meier curves adjusted for trial cohort (ODYSSEY A or ODYSSEY B)|"Statistical Analysis Title: Adjusted difference (frequentist \<14kg)~Statistical analysis description: Difference in adjusted (for stratification factors) Kaplan-Meier survival function estimates at 96 weeks after randomisation.~Number of subjects included in analysis: 85~Analysis Specification: Pre-specified"||0.029|-0.362|= 0.075
72517702|NCT02259127|144564820|NON_INFERIORITY|"\>=14kg cohort: Non-inferiority margin 10% in total population and 12% in ODYSSEY A/ODYSSEY B.~\<14kg cohort: power for efficacy was not prespecified for this cohort."|Risk Difference (RD)|-0.126|||=|0.004|TWO_SIDED|95.0|-0.21|-0.036|||Bootstrap method||The probability of having virological or clinical treatment failure by 96 weeks (per protocol analysis) was estimated using Kaplan-Meier curves adjusted for stratification factors.|"Statistical Analysis Title: Adjusted Difference (ODYSSEY A \>=14kg)~Statistical analysis description: Difference in adjusted (for stratification factors) Kaplan-Meier survival function estimates at 96 weeks after randomisation.~Number of subjects included in analysis: 295~Analysis Specification: Pre-specified"||-0.036|-0.21|= 0.004
72569405|NCT00444457|144669743|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|0.6|||||TWO_SIDED|95.0|-0.45|2.1|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Additional serotypes - serotype 19A||2.10|-0.45|
72569406|NCT00444457|144669743|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|0.3|||||TWO_SIDED|95.0|-0.75|1.58|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Additional serotypes - serotype 19A||1.58|-0.75|
72569407|NCT00444457|144669743|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|-0.3|||||TWO_SIDED|95.0|-1.86|1.05|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Additional serotypes - serotype 19A||1.05|-1.86|
72569408|NCT00444457|144669744|SUPERIORITY_OR_OTHER||Difference in log-transformed GM|0.02|||||TWO_SIDED|95.0|-0.1|0.13|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Common serotypes - serotype 4||0.13|-0.10|
72569409|NCT00444457|144669744|SUPERIORITY_OR_OTHER||Difference in log-transformed GM|-0.29|||||TWO_SIDED|95.0|-0.41|-0.17|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Common serotypes - serotype 4||-0.17|-0.41|
72569410|NCT00444457|144669744|SUPERIORITY_OR_OTHER||Difference in log-transformed GM|-0.31|||||TWO_SIDED|95.0|-0.43|-0.19|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Common serotypes - serotype 4||-0.19|-0.43|
72569411|NCT00444457|144669744|SUPERIORITY_OR_OTHER||Difference in log-transformed GM|0.18|||||TWO_SIDED|95.0|0.06|0.3|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Common serotypes - serotype 6B||0.30|0.06|
72569412|NCT00444457|144669744|SUPERIORITY_OR_OTHER||Difference in log-transformed GM|0.12|||||TWO_SIDED|95.0|0.0|0.23|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Common serotypes - serotype 6B||0.23|-0.00|
72569413|NCT00444457|144669744|SUPERIORITY_OR_OTHER||Difference in log-transformed GM|-0.06|||||TWO_SIDED|95.0|-0.18|0.06|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Common serotypes - serotype 6B||0.06|-0.18|
72405143|NCT02272413|144317890|OTHER||Risk Ratio (RR)|1.16|||||TWO_SIDED|95.0|0.51|2.76|||Score exact method|||Febrile neutropenia, risk ratio X (BI 695502) versus Y (US-licensed Avastin®) was defined as (a/(a+b))/(c/(c+d)), where 'a' was the number of patients with TEAEs selected for comparability within treatment group X, 'a+b' was the total number of patients in treatment group X, 'c' was the number of patients with TEAEs selected for comparability within treatment group Y and 'c+d' was the total number of patients in treatment group Y.||2.76|0.51|
72405144|NCT02272413|144317890|OTHER||Risk Ratio (RR)|3.43|||||TWO_SIDED|95.0|0.79|32.82|||Score exact method|||Gastrointestinal perforations, risk ratio X (BI 695502) versus Y (US-licensed Avastin®) was defined as (a/(a+b))/(c/(c+d)), where 'a' was the number of patients with TEAEs selected for comparability within treatment group X, 'a+b' was the total number of patients in treatment group X, 'c' was the number of patients with TEAEs selected for comparability within treatment group Y and 'c+d' was the total number of patients in treatment group Y.||32.82|0.79|
72405145|NCT02272413|144317890|OTHER||Risk Ratio (RR)|0.96|||||TWO_SIDED|95.0|0.66|1.39|||Score exact method|||Hypertension, risk ratio X (BI 695502) versus Y (US-licensed Avastin®) was defined as (a/(a+b))/(c/(c+d)), where 'a' was the number of patients with TEAEs selected for comparability within treatment group X, 'a+b' was the total number of patients in treatment group X, 'c' was the number of patients with TEAEs selected for comparability within treatment group Y and 'c+d' was the total number of patients in treatment group Y.||1.39|0.66|
72405146|NCT02272413|144317890|OTHER||Risk Ratio (RR)|1.08|||||TWO_SIDED|95.0|0.74|1.57|||Score exact method|||Proteinuria, risk ratio X (BI 695502) versus Y (US-licensed Avastin®) was defined as (a/(a+b))/(c/(c+d)), where 'a' was the number of patients with TEAEs selected for comparability within treatment group X, 'a+b' was the total number of patients in treatment group X, 'c' was the number of patients with TEAEs selected for comparability within treatment group Y and 'c+d' was the total number of patients in treatment group Y.||1.57|0.74|
72405147|NCT02272413|144317890|OTHER||Risk Ratio (RR)|1.31|||||TWO_SIDED|95.0|0.28|10.79|||Score exact method|||Pulmonary haemorrhage, risk ratio X (BI 695502) versus Y (US-licensed Avastin®) was defined as (a/(a+b))/(c/(c+d)), where 'a' was the number of patients with TEAEs selected for comparability within treatment group X, 'a+b' was the total number of patients in treatment group X, 'c' was the number of patients with TEAEs selected for comparability within treatment group Y and 'c+d' was the total number of patients in treatment group Y.||10.79|0.28|
72492026|NCT05032157|144512683|SUPERIORITY||Odds Ratio (OR)|2.75|||<|0.001|TWO_SIDED|95.0|1.65|4.58|||Regression, Logistic||Logistic regression adjusting for treatment arm, geographical region, prior exposure to anti-IgE biologics and baseline DLQI score.|Dermatology Life Quality Index (DLQI) = 0-1 at Week 12||4.58|1.65|< 0.001
72492027|NCT05032157|144512684|SUPERIORITY||Rate ratio|3.26|||<|0.001|TWO_SIDED|95.0|2.26|4.71|||Regression, Linear||Negative binomial regression with log link includes treatment arm as fixed effect, geographical region, prior exposure to anti-IgE biologics as covariates. A rate ratio \>1 favors LOU064 25 mg b.i.d.|Disease activity control (UAS7 =\< 6) up to Week 12||4.71|2.26|< 0.001
72492028|NCT05032157|144512685|SUPERIORITY||Rate ratio|1.32|||<|0.001|TWO_SIDED|95.0|1.17|1.49|||Regression, Linear||Negative binomial regression with log link included treatment arm as fixed effect, geographical region, prior exposure to anti-IgE biologics, baseline AAS7 = 0 response as covariates. A rate ratio \> 1 favors LOU064 25 mg b.i.d.|Angioedema occurrence-free weeks (AAS7 = 0 response) up to Week 12||1.49|1.17|< 0.001
72492029|NCT01979523|144512708|OTHER|||||||0.74|||||||Log Rank|||||||0.74
72492030|NCT03716869|144512720|SUPERIORITY||Odds Ratio (OR)|2.07|||<|0.001|TWO_SIDED|95.0|1.39|3.1|||Regression, Logistic|||Statistical analysis was conducted using the intent-to-treat principle. Analysis for primary and secondary outcomes that compared universal to targeted screening was conducted using mixed effects logistic regression.||3.10|1.39|<0.001
72492031|NCT03716869|144512721|SUPERIORITY||Odds Ratio (OR)|5.92|||<|0.001|TWO_SIDED|95.0|5.07|6.93|||Regression, Logistic|||||6.93|5.07|<0.001
72492032|NCT03716869|144512723|SUPERIORITY||Odds Ratio (OR)|3.3|||<|0.001|TWO_SIDED|95.0|2.49|4.38|||Regression, Logistic|||||4.38|2.49|<0.001
72569414|NCT00444457|144669744|SUPERIORITY_OR_OTHER||Difference in log-transformed GM|-0.02|||||TWO_SIDED|95.0|-0.13|0.09|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Common serotypes - serotype 9V||0.09|-0.13|
72492033|NCT03716869|144512729|SUPERIORITY||Odds Ratio (OR)|8.42|||<|0.001|TWO_SIDED|95.0|6.71|10.58|||Regression, Logistic||Test of interaction terms from mixed-effects logistic regression for subgroup analyses. Information above is sex x rand group interaction for identification of MDD symptoms among females. For males, OR 4.05 (95% CI 3.26-5.03).||"Sex x rand group interaction p=0.005 for SAP confirmation of need for follow-up.~Females 4.73 (3.19-7.02) Males 2.09 (1.38-3.16)~Sex x rand group interaction p=0.37 for treatment initiation. OR is not reported due to p\>0.05."|10.58|6.71|<0.001
72492034|NCT03716869|144512729|SUPERIORITY||Odds Ratio (OR)|8.65|||<|0.001|TWO_SIDED|95.0|6.58|11.35|||Regression, Logistic||Information above is for race/ethnicity x rand group interaction for identification of MDD symptoms for non-Hispanic white students. For non-Hispanic Black students OR 2.55 (95% CI 1.97-3.31), Hispanic 7.45 (4.98-11.17), other 12.41 (7.34-21.00).||"Race/ethnicity x rand group p=0.007 for SAP confirmation of need for follow-up. non-Hispanic white 2.24 (1.59-3.15) non-Hispanic Black 4.19 (2.03-8.65) Hispanic 10.15 (4.06-25.36) Other 12.22 (1.59-94.12)~Race/ethnicity x rand group interaction p=0.15 for treatment initiation. OR is not reported due to p\>0.05."|11.35|6.58|<0.001
72492035|NCT03716869|144512729|SUPERIORITY||Odds Ratio (OR)|5.47||||0.006|TWO_SIDED|95.0|4.65|6.44|||Regression, Logistic||Information above is location x rand group interaction for identification of MDD symptoms among urban students. For rural students and identification of depressive symptoms OR 13.60 (95% CI 7.28-25.42).||"Location x rand group interaction p=0.27 for SAP confirmation of need for follow-up. OR is not reported due to p\>0.05.~Location x rand group interaction p=0.36 for treatment initiation. OR is not reported due to p\>0.05."|6.44|4.65|0.006
72492036|NCT01709149|144512733|SUPERIORITY||Least squares mean difference|-0.58|STANDARD_ERROR_OF_MEAN|0.366||0.114|TWO_SIDED|95.0|-1.3|0.14|||Repeated-measures mixed model||Least squares mean difference: tirasemtiv minus placebo|||0.14|-1.30|0.1140
72492037|NCT01709149|144512734|SUPERIORITY||Least squares mean difference|0.48|STANDARD_ERROR_OF_MEAN|1.963||0.8083|TWO_SIDED|95.0|-3.38|4.34|||Repeated-measures mixed model||Least squares mean difference: tirasemtiv minus placebo|||4.34|-3.38|0.8083
72405148|NCT02272413|144317890|OTHER||Risk Ratio (RR)|1.24|||||TWO_SIDED|95.0|0.88|1.74|||Score exact method|||Other hemorrhages, risk ratio X (BI 695502) versus Y (US-licensed Avastin®) was defined as (a/(a+b))/(c/(c+d)), where 'a' was the number of patients with TEAEs selected for comparability within treatment group X, 'a+b' was the total number of patients in treatment group X, 'c' was the number of patients with TEAEs selected for comparability within treatment group Y and 'c+d' was the total number of patients in treatment group Y.||1.74|0.88|
72405149|NCT02272413|144317890|OTHER||Risk Ratio (RR)|1.26|||||TWO_SIDED|95.0|0.47|3.57|||Score excat method|||Wound healing complications/ abscesses/ fistulas, risk ratio X (BI 695502) versus Y (US-licensed Avastin®) was defined as (a/(a+b))/(c/(c+d)), where 'a' was the number of patients with TEAEs selected for comparability within treatment group X, 'a+b' was the total number of patients in treatment group X, 'c' was the number of patients with TEAEs selected for comparability within treatment group Y and 'c+d' was the total number of patients in treatment group Y.||3.57|0.47|
72405150|NCT02272413|144317891|OTHER||Hazard Ratio (HR)|1.22|||||TWO_SIDED|95.0|1.02|1.45|||Cox-proportional hazards regression|||Analysis based on a Cox-proportional hazards regression model. The model included the following explanatory variables: treatment, sex (male versus female), smoking status (never smoked versus current/ex-smoker), NSCLC stage (recurrent versus Stage IV) and ethnicity (East Asian origin versus non East Asian).||1.45|1.02|
72569415|NCT00444457|144669744|SUPERIORITY_OR_OTHER||Difference in log-transformed GM|-0.04|||||TWO_SIDED|95.0|-0.15|0.07|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Common serotypes - serotype 9V||0.07|-0.15|
72569416|NCT00444457|144669744|SUPERIORITY_OR_OTHER||Difference in log-transformed GM|-0.02|||||TWO_SIDED|95.0|-0.13|0.09|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Common serotypes - serotype 9V||0.09|-0.13|
72569417|NCT00444457|144669744|SUPERIORITY_OR_OTHER||Difference in log-transformed GM|-0.06|||||TWO_SIDED|95.0|-0.19|0.06|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Common serotypes - serotype 14||0.06|-0.19|
72569418|NCT00444457|144669744|SUPERIORITY_OR_OTHER||Difference in log-transformed GM|-0.04|||||TWO_SIDED|95.0|-0.17|0.08|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Common serotypes - serotype 14||0.08|-0.17|
72569419|NCT00444457|144669744|SUPERIORITY_OR_OTHER||Difference in log-transformed GM|0.02|||||TWO_SIDED|95.0|-0.11|0.15|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Common serotypes - serotype 14||0.15|-0.11|
72569420|NCT00444457|144669744|SUPERIORITY_OR_OTHER||Difference in log-transformed GM|-0.12|||||TWO_SIDED|95.0|-0.25|0.0|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Common serotypes - serotype 18C||0.00|-0.25|
72569421|NCT00444457|144669744|SUPERIORITY_OR_OTHER||Difference in log-transformed GM|-0.24|||||TWO_SIDED|95.0|-0.37|-0.12|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Common serotypes - serotype 18C||-0.12|-0.37|
72569422|NCT00444457|144669744|SUPERIORITY_OR_OTHER||Difference in log-transformed GM|-0.12|||||TWO_SIDED|95.0|-0.25|0.01|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Common serotypes - serotype 18C||0.01|-0.25|
72492038|NCT01709149|144512735|SUPERIORITY||Least squares mean difference|-3.4|STANDARD_ERROR_OF_MEAN|1.627||0.0372|TWO_SIDED|95.0|-6.6|-0.2|||Repeated-measures mixed model||Least squares mean difference: tirasemtiv minus placebo|||-0.20|-6.60|0.0372
72492039|NCT01709149|144512736|SUPERIORITY||Least squares mean difference|4.25|STANDARD_ERROR_OF_MEAN|1.03|<|0.0001|TWO_SIDED|95.0|2.23|6.28|||Repeated-measures mixed model||Least squares mean difference: tirasemtiv minus placebo|||6.28|2.23|<0.0001
72492040|NCT01709149|144512737|SUPERIORITY||Least squares mean difference|0.75|STANDARD_ERROR_OF_MEAN|0.956||0.4328|TWO_SIDED|95.0|-1.13|2.63|||Repeated-measures mixed model||Least squares mean difference: tirasemtiv minus placebo|||2.63|-1.13|0.4328
72492041|NCT01709149|144512738|SUPERIORITY||Least squares mean difference|0.25|STANDARD_ERROR_OF_MEAN|4.399||0.9546|TWO_SIDED|95.0|-8.4|8.9|||Repeated-measures mixed model||Least squares mean difference: tirasemtiv minus placebo|||8.90|-8.40|0.9546
72492042|NCT01709149|144512739|SUPERIORITY||Least squares mean difference|1.61|STANDARD_ERROR_OF_MEAN|3.207||0.6166|TWO_SIDED|95.0|-4.7|7.91|||Repeated-measures mixed model||Least squares mean difference: tirasemtiv minus placebo|||7.91|-4.70|0.6166
72492043|NCT00535132|144512743|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.4|STANDARD_DEVIATION|1.4|<|0.001||||||p-value based on a paired t-test for a within-group comparison.|t-test, 2 sided|||Sample size for this study was based on changes in the MSQ scores within subjects from baseline to endpoint using a one-sample paired t-test. A sample size of 97 subjects was shown to have 90% power at endpoint to detect a mean change from baseline of 0.5 units on the MSQ score, with a standard deviation of 1.5. Allowing for extra variability from subjects with prior generic risperidone (instead of branded risperidone) use, this number was increased to 150 subjects.||||<0.001
72492044|NCT00535132|144512744|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.8|STANDARD_DEVIATION|1.4|<|0.001|||||||t-test, 2 sided|p-value for within-group comparison based on a paired t-test.||||||<0.001
72492045|NCT00535132|144512745|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.3|STANDARD_DEVIATION|1.4|<|0.001|||||||t-test, 2 sided|||||||<0.001
72492046|NCT00535132|144512746|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.5|STANDARD_DEVIATION|1.3|<|0.001|||||||t-test, 2 sided|p-value for within-group comparison based on a paired t-test.||||||<0.001
72492047|NCT00535132|144512747|SUPERIORITY_OR_OTHER|||||||0.002|||||||Fisher Exact|P-values for the study group comparisons using dichotomized categories are based on Fisher's Exact Test.||||||0.002
72492048|NCT00535132|144512748|SUPERIORITY_OR_OTHER|||||||0.033||95.0|||||Fisher Exact|P-values for the study group comparisons using dichotomized categories are based on Fisher's Exact Test.||||||0.033
72405151|NCT02272413|144317892|OTHER||Hazard Ratio (HR)|1.23|||||TWO_SIDED|95.0|1.0|1.51|||Cox-proportional hazards regression|||Analysis based on a Cox-proportional hazards regression model. The model included the following explanatory variables: treatment, sex (male versus female), smoking status (never smoked versus current/ex-smoker), NSCLC stage (recurrent versus Stage IV) and ethnicity (East Asian origin versus non East Asian).||1.51|1.00|
72405152|NCT02272413|144317893|OTHER||Hazard Ratio (HR)|1.14|||||TWO_SIDED|95.0|0.88|1.48|||Cox-proportional hazards regression|||Analysis based on a Cox-proportional hazards regression model. The model included the following explanatory variables: treatment, sex (male versus female), smoking status (never smoked versus current/ex-smoker), NSCLC stage (recurrent versus Stage IV) and ethnicity (East Asian origin versus non East Asian).||1.48|0.88|
72405153|NCT04630093|144317915|SUPERIORITY|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||Baseline vs. 6 months after receiving panel-based pharmacogenetic testing||||0.001
72405154|NCT01465464|144317974|SUPERIORITY||Hazard Ratio (HR)|1.09||||0.435|TWO_SIDED|95.0|0.878|1.352|||Log Rank|||||1.352|0.878|0.435
72405155|NCT01554618|144317980|SUPERIORITY||LS Mean Difference|-0.85|STANDARD_ERROR_OF_MEAN|0.33||0.012|TWO_SIDED|95.0|-1.51|-0.19|||Mixed Models Analysis||Exenatide versus Placebo|Adjusted LS mean and treatment group difference in the change from baseline at Week 24 were modeled using a MMRM including treatment group, region, visit, and treatment group by visit interaction, baseline HbA1c value (continuous) and baseline HbA1c by visit interaction as fixed effects, using an unstructured covariance matrix.||-0.19|-1.51|0.012
72405156|NCT01554618|144317983|SUPERIORITY||LS Mean Difference|-21.6|STANDARD_ERROR_OF_MEAN|13.7||0.119|TWO_SIDED|95.0|-49.0|5.7|||Mixed Models Analysis||Exenatide versus Placebo|Adjusted LS mean and treatment group difference in the change from baseline at Week 24 were modeled using a MMRM including treatment group, region, visit, and treatment group by visit interaction, baseline fasting plasma glucose value, screening HbA1c (\< 9.0% or ≥ 9.0%), and baseline fasting plasma glucose by visit interaction as fixed effects, using an unstructured covariance matrix.||5.7|-49.0|0.119
72405157|NCT01554618|144317984|SUPERIORITY||LS Mean Difference|-1.22|STANDARD_ERROR_OF_MEAN|1.189||0.307|TWO_SIDED|95.0|-3.59|1.15|||Mixed Models Analysis||Exenatide versus Placebo|Adjusted LS mean and treatment group difference in the change from baseline at Week 24 were modeled using a MMRM including treatment group, region, visit, and treatment group by visit interaction, baseline body weight, screening HbA1c (\< 9.0% or ≥ 9.0%), and baseline body weight by visit interaction as fixed effects, using an unstructured covariance matrix.||1.15|-3.59|0.307
72405158|NCT01554618|144317985|SUPERIORITY||LS Mean Difference|94.9|STANDARD_ERROR_OF_MEAN|95.26||0.323|TWO_SIDED|95.0|-95.6|285.5|||Mixed Models Analysis||Exenatide versus Placebo|Adjusted LS mean and treatment group difference in the change from baseline at Week 24 were modeled using a MMRM including treatment group, region, visit, treatment group by visit interaction, baseline fasting insulin, screening HbA1c (\< 9.0% or ≥ 9.0%), and baseline fasting insulin by visit interaction as fixed effects, using an unstructured covariance matrix.||285.5|-95.6|0.323
72492049|NCT00535132|144512749|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.9|STANDARD_DEVIATION|13.1|<|0.001|||||||t-test, 2 sided|p-value for within-group comparison based on a paired t-test.||||||<0.001
72492050|NCT00535132|144512750|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8|STANDARD_DEVIATION|0.9|<|0.001|||||||t-test, 2 sided|p-value for within-group comparison based on a paired t-test.||||||<0.001
72492051|NCT00535132|144512751|SUPERIORITY_OR_OTHER|||||||0.123||95.0||||P-values for the study group comparisons using dichotomized categories are based on Fisher's Exact Test.|Fisher Exact|||||||0.123
72492052|NCT00535132|144512752|SUPERIORITY_OR_OTHER|||||||0.125||95.0|||||Fisher Exact|P-values for the study group comparisons using dichotomized categories are based on Fisher's Exact Test.||||||0.125
72517703|NCT02259127|144564820|NON_INFERIORITY|"\>=14kg cohort: Non-inferiority margin 10% in total population and 12% in ODYSSEY A/ODYSSEY B.~\<14kg cohort: power for efficacy was not prespecified for this cohort."|Risk Difference (RD)|-0.023|||=|0.547|TWO_SIDED|95.0|-0.096|0.056|||Bootstrap method||The probability of having virological or clinical treatment failure by 96 weeks (per protocol analysis) was estimated using Kaplan-Meier curves adjusted for stratification factors.|"Statistical Analysis Title: Adjusted Difference (ODYSSEY B \>=14kg)~Statistical analysis description: Difference in adjusted (for stratification factors) Kaplan-Meier survival function estimates at 96 weeks after randomisation.~Number of subjects included in analysis: 382~Analysis Specification: Pre-specified"||0.056|-0.096|= 0.547
72405159|NCT01554618|144317986|SUPERIORITY||Difference|14.8||||0.077|TWO_SIDED|95.0|1.9|27.7|||Cochran-Mantel-Haenszel||Exenatide versus Placebo. Difference was the risk difference of the 2 proportions.|"Treatment difference in HbA1c \< 6.5%:~Treatment group comparison was based on CMH test stratified by screening HbA1c (\<9.0% or \>=9.0%). P-value was from the general association statistic."||27.7|1.9|0.077
72405160|NCT01554618|144317986|SUPERIORITY||Difference|14.8||||0.077|TWO_SIDED|95.0|1.9|27.7|||Cochran-Mantel-Haenszel||Exenatide versus Placebo. Difference was the risk difference of the 2 proportions.|"Treatment difference in HbA1c ≤ 6.5%:~Treatment group comparison was based on CMH test stratified by screening HbA1c (\<9.0% or \>=9.0%). P-value was from the general association statistic."||27.7|1.9|0.077
72405161|NCT01554618|144317986|SUPERIORITY||Difference|22.7||||0.02|TWO_SIDED|95.0|6.5|39.0|||Cochran-Mantel-Haenszel||Exenatide versus Placebo. Difference was the risk difference of the 2 proportions.|"Treatment difference in HbA1c \< 7.0%:~Treatment group comparison was based on CMH test stratified by screening HbA1c (\<9.0% or \>=9.0%). P-value was from the general association statistic."||39.0|6.5|0.020
72492053|NCT00535132|144512753|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|28.3|STANDARD_DEVIATION|23.1|<|0.001||||||p-value for within-group comparison based on a paired t-test.|t-test, 2 sided|||||||<0.001
72492054|NCT00535132|144512754|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.5|STANDARD_DEVIATION|7.5||0.009|||||||t-test, 2 sided|p-value for within-group comparison based on a paired t-test.||||||0.009
72492055|NCT00535132|144512755|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.0|STANDARD_DEVIATION|10.4|<|0.001|||||||t-test, 2 sided|p-value for within-group comparison based on a paired t-test.||||||<0.001
72492056|NCT00535132|144512756|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.3|STANDARD_DEVIATION|4.3|<|0.001|||||||t-test, 2 sided|p-value for within-group comparison based on a paired t-test.||||||<0.001
72492057|NCT00535132|144512757|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.3|STANDARD_DEVIATION|3.0|<|0.001|||||||t-test, 2 sided|p-value for within-group comparison based on a paired t-test.||||||<0.001
72405162|NCT01554618|144317988|SUPERIORITY||LS Mean Difference|-2.8|STANDARD_ERROR_OF_MEAN|2.61||0.284|TWO_SIDED|95.0|-8.0|2.4|||Mixed Models Analysis||Exenatide versus Placebo|"Treatment difference in SBP:~Adjusted LS mean and treatment group difference in the change from baseline at Week 24 were modeled using a MMRM including treatment group, region, visit, treatment group by visit interaction, baseline SBP, screening HbA1c (\< 9.0% or ≥ 9.0%), and baseline SBP by visit interaction as fixed effects, using an unstructured covariance matrix."||2.4|-8.0|0.284
72405163|NCT01554618|144317988|SUPERIORITY||LS Mean Difference|1.6|STANDARD_ERROR_OF_MEAN|1.77||0.376|TWO_SIDED|95.0|-2.0|5.1|||Mixed Models Analysis||Exenatide versus Placebo|"Treatment difference in DBP:~Adjusted LS mean and treatment group difference in the change from baseline at Week 24 were modeled using a MMRM including treatment group, region, visit, treatment group by visit interaction, baseline DBP, screening HbA1c (\< 9.0% or ≥ 9.0%), and baseline DBP by visit interaction as fixed effects, using an unstructured covariance matrix."||5.1|-2.0|0.376
72517704|NCT02259127|144564835|SUPERIORITY||Mean Difference (Final Values)|1.0|||=|0.004|TWO_SIDED|95.0|0.3|1.7|||Regression, Linear|||"Statistical Analysis Title: Adjusted Difference (\>=14kg)~Number of subjects included in analysis: 707~Analysis Specification: Pre-specified"||1.7|0.3|= 0.004
72517705|NCT02259127|144564835|SUPERIORITY||Mean Difference (Final Values)|1.4|||=|0.024|TWO_SIDED|95.0|0.2|2.5|||Regression, Linear|||"Statistical Analysis Title: Adjusted Difference (ODYSSEY A \>=14kg)~Statistical analysis description: Linear regression of weight at week 96, adjusting for randomised arm, baseline weight and stratification factors. Presenting mean difference between arms.~Number of subjects included in analysis: 311~Analysis Specification: Pre-specified"||2.5|0.2|= 0.024
72517706|NCT02259127|144564835|SUPERIORITY||Mean Difference (Final Values)|0.8|||=|0.075|TWO_SIDED|95.0|-0.1|1.6|||Regression, Linear|||"Statistical Analysis Title: Adjusting Difference (ODYSSEY B \>=14kg)~Statistical analysis description: Linear regression of weight at week 96, adjusting for randomised arm, baseline weight and stratification factors. Presenting mean difference between arms.~Number of subjects included in analysis: 396~Analysis Specification: Pre-specified"||1.6|-0.1|= 0.075
72517707|NCT02259127|144564835|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.67|TWO_SIDED|95.0|-0.8|0.5|||Regression, Linear|||||0.5|-0.8|0.67
72517708|NCT02259127|144564836|SUPERIORITY||Mean Difference (Final Values)|0.13|||=|0.036|TWO_SIDED|95.0|0.01|0.25|||Regression, Linear|||"Statistical Analysis Title: Adjusted Difference (\>=14kg)~Statistical analysis description: Linear regression of BMI-for-age at week 96, adjusting for randomised arm, baseline BMI-for-age and stratification factors. Presenting mean difference between arms.~Number of subjects included in analysis: 707~Analysis Specification: Pre-specified"||0.25|0.01|= 0.036
72517709|NCT02259127|144564836|SUPERIORITY||Mean Difference (Final Values)|0.17|||=|0.092|TWO_SIDED|95.0|-0.03|0.36|||Regression, Linear|||"Statistical Analysis Title: Adjusted Difference (ODYSSEY A \>=14kg)~Statistical analysis description: Linear regression of BMI-for-age at week 96, adjusting for randomised arm, baseline BMI-for-age and stratification factors. Presenting mean difference between arms.~Number of subjects included in analysis: 311~Analysis Specification: Pre-specified"||0.36|-0.03|=0.092
72517710|NCT02259127|144564836|SUPERIORITY||Mean Difference (Final Values)|0.1|||=|0.176|TWO_SIDED|95.0|-0.05|0.25|||Regression, Linear|||"Statistical Analysis Title: Adjusted Difference (ODYSSEY B \>=14kg)~Statistical analysis description: Linear regression of BMI-for-age at week 96, adjusting for randomised arm, baseline BMI-for-age and stratification factors. Presenting mean difference between arms.~Number of subjects included in analysis: 396~Analysis Specification: Pre-specified"||0.25|-0.05|=0.176
72517711|NCT02259127|144564836|SUPERIORITY||Mean Difference (Final Values)|-0.3||||0.5|TWO_SIDED|95.0|-1.1|0.5|||Regression, Linear|||||0.5|-1.1|0.50
72517712|NCT03788967|144564842|NON_INFERIORITY|The non-inferiority hypothesis test was a 1-sided hypothesis test performed at the 2.5% level of significance. If the lower limit of the 95% CI for the difference in overall response was greater than -12.5%, non-inferiority was declared.|Risk Difference|-3.3|||||TWO_SIDED|95.0|-9.7|3.2||||||||3.2|-9.7|
72405164|NCT01554618|144317990|SUPERIORITY||LS Mean Difference|90.37|STANDARD_ERROR_OF_MEAN|69.207||0.211|TWO_SIDED|95.0|-57.27|238.0|||Mixed Models Analysis||Exenatide versus Placebo|"Treatment difference in HOMA-B:~Adjusted LS mean and treatment group difference in the change from baseline at Week 24 were modeled using a MMRM including treatment group, region, visit, treatment group by visit interaction, baseline HOMA-B, screening HbA1c (\< 9.0% or ≥ 9.0%), and baseline HOMA-B by visit interaction as fixed effects, using an unstructured covariance matrix."||238.00|-57.27|0.211
72405165|NCT01554618|144317990|SUPERIORITY||LS Mean Difference|-6.75|STANDARD_ERROR_OF_MEAN|6.173||0.289|TWO_SIDED|95.0|-19.8|6.29|||Mixed Models Analysis||Exenatide versus Placebo|"Treatment difference in HOMA-S:~Adjusted LS mean and treatment group difference in the change from baseline at Week 24 were modeled using a MMRM including treatment group, region, visit, treatment group by visit interaction, baseline HOMA-S, screening HbA1c (\< 9.0% or ≥ 9.0%), and baseline HOMA-S by visit interaction as fixed effects, using an unstructured covariance matrix."||6.29|-19.80|0.289
72517713|NCT03788967|144564844|OTHER||Risk Difference|-4.7|||||TWO_SIDED|95.0|-11.3|1.9||||||||1.9|-11.3|
72517714|NCT03788967|144564845|OTHER||Risk Difference|1.4|||||TWO_SIDED|95.0|-0.1|3.4||||||Statistical Analysis 1 (EOT)||3.4|-0.1|
72517715|NCT03788967|144564845|OTHER||Risk Difference|-0.6|||||TWO_SIDED|95.0|-4.0|2.8||||||Statistical Analysis 2 (TOC)||2.8|-4|
72517716|NCT03788967|144564845|OTHER||Risk Difference|-1.5|||||TWO_SIDED|95.0|-5.7|2.6||||||Statistical Analysis 3 (LFU)||2.6|-5.7|
72517717|NCT03788967|144564846|OTHER||Risk Difference|0.7|||||TWO_SIDED|95.0|-0.3|2.0||||||||2.0|-0.3|
72517718|NCT03788967|144564847|OTHER||Risk Difference|-1.6|||||TWO_SIDED|95.0|-3.8|0.6||||||||0.6|-3.8|
72517719|NCT03788967|144564848|OTHER||Risk Difference|-0.5|||||TWO_SIDED|95.0|-3.3|2.3||||||||2.3|-3.3|
72517720|NCT03788967|144564849|OTHER||Risk Difference|1.3|||||TWO_SIDED|95.0|-0.2|3.2||||||||3.2|-0.2|
72517721|NCT03788967|144564850|OTHER||Risk Difference|-2.2|||||TWO_SIDED|95.0|-5.3|0.8||||||||0.8|-5.3|
72517722|NCT03788967|144564851|OTHER||Risk Difference|-1.2|||||TWO_SIDED|95.0|-5.1|2.6||||||||2.6|-5.1|
72517723|NCT03788967|144564852|OTHER||Risk Difference|1.5|||||TWO_SIDED|95.0|-0.8|4.1||||||Statistical Analysis 1 (EOT)||4.1|-0.8|
72517724|NCT03788967|144564852|OTHER||Risk Difference|-4.5|||||TWO_SIDED|95.0|-10.8|1.9||||||Statistical Analysis 2 (TOC)||1.9|-10.8|
72492058|NCT01857713|144512765|NON_INFERIORITY_OR_EQUIVALENCE|It was assumed that the study would be successful if the mean % reduction is significantly greater than 25%. Assuming a 35% reduction in RSI, a power of 80%, one-sided significance level of 0.05, 85 subjects are required for the study. It was decided to recruit up to 100 subjects for this study.|||||<|0.05|||||||t-test, 1 sided|||The sample size was based on the primary effectiveness variable (% reduction in RSI from Baseline to Week 4). It was assumed that the study would be successful if the mean % reduction is significantly greater than 25%. Assuming a 35% reduction in RSI, a power of 80%, one-sided significance level of 0.05, 85 subjects are required for the study. It was decided to recruit up to 100 subjects for this study.||||<0.05
72492059|NCT03759665|144512771|SUPERIORITY||Hodges-Lehmann Estimator|0.75||||0.044|TWO_SIDED|90.0|0.0|1.5|||1-sided Wilcoxon signed-rank test|||||1.50|0.00|0.044
72492060|NCT03759665|144512773|SUPERIORITY||Hodges-Lehmann Estimator|0.13||||0.206|TWO_SIDED|90.0|-0.13|0.25|||1-sided Wilcoxon signed-rank test|||||0.25|-0.13|0.206
72492061|NCT03759665|144512776|SUPERIORITY||Hodges-Lehmann Estimator|0.0327||||0.21|TWO_SIDED|90.0|-0.0327|0.104|||1-sided Wilcoxon signed-rank test|||Treatment With IB1001||0.1040|-0.0327|0.210
72492062|NCT03759665|144512776|SUPERIORITY||Hodges-Lehmann Estimator|-0.0291||||0.212|TWO_SIDED|90.0|-0.0863|0.0262|||1-sided Wilcoxon signed-rank test|||Post-Treatment Washout||0.0262|-0.0863|0.212
72492063|NCT03759665|144512777|SUPERIORITY||Hodges-Lehmann Estimator|-1.25|||<|0.001|TWO_SIDED|90.0|-1.75|-0.75|||1-sided Wilcoxon signed-rank test|||Treatment With IB1001||-0.75|-1.75|<0.001
72492064|NCT03759665|144512777|SUPERIORITY||Hodges-Lehmann Estimator|1.25||||0.001|TWO_SIDED|90.0|0.5|2.0|||1-sided Wilcoxon signed-rank test|||Post-Treatment Washout||2.00|0.50|0.001
72492065|NCT03759665|144512779|SUPERIORITY||Hodges-Lehmann Estimator|-0.031||||0.02|TWO_SIDED|90.0|-0.063|0.0|||1-sided Wilcoxon signed-rank test|||Treatment with IB1001||0.000|-0.063|0.020
72492066|NCT03759665|144512779|SUPERIORITY||Hodges-Lehmann Estimator|0.042|||<|0.001|TWO_SIDED|90.0|0.021|0.063|||1-sided Wilcoxon signed-rank test|||Post-Treatment Washout||0.063|0.021|<0.001
72492067|NCT03759665|144512780|SUPERIORITY||Hodges-Lehmann Estimator|3.0|||<|0.001|TWO_SIDED|90.0|3.0|3.5|||1-sided Wilcoxon signed-rank test|||Treatment With IB1001||3.5|3.0|<0.001
72492068|NCT03759665|144512780|SUPERIORITY||Hodges-Lehmann Estimator|5.0|||<|0.001|TWO_SIDED|90.0|4.5|5.0|||1-sided Wilcoxon signed-rank test|||Post-Treatment Washout||5.0|4.5|<0.001
72517725|NCT03788967|144564852|OTHER||Risk Difference|-1.5|||||TWO_SIDED|95.0|-7.9|5.0||||||||5|-7.9|
72517726|NCT03788967|144564856|OTHER||Risk Difference|-0.2|||||TWO_SIDED|95.0|-1.6|1.2||||||||1.2|-1.6|
72517727|NCT03788967|144564857|OTHER||Risk Difference|-5.9|||||TWO_SIDED|95.0|-12.4|0.7||||||||0.7|-12.4|
72517728|NCT03788967|144564858|OTHER||Risk Difference (RD)|-1.6|||||TWO_SIDED|95.0|-8.5|5.3||||||||5.3|-8.5|
72492069|NCT01857869|144512783|OTHER||1-Relative Risk|86.7|||<|0.0001|TWO_SIDED|95.0|66.8|94.6||Two-sided Fisher Exact test was used for the comparison of malaria incidence after first/second CHMI between the compared groups.|Mantel Haenszel|||Vaccine efficacy (VE) was defined as 100\*(1-Relative Risk \[RR\]).||94.6|66.8|<0.0001
72492070|NCT01857869|144512783|OTHER||1-Relative Risk|62.5||||0.0009|TWO_SIDED|95.0|29.4|80.1||Two-sided Fisher Exact test was used for the comparison of malaria incidence after first/second CHMI between the compared groups.|Mantel Haenszel|||Vaccine efficacy (VE) was defined as 100\*(1-Relative Risk \[RR\]).||80.1|29.4|0.0009
72517729|NCT03788967|144564862|OTHER||Risk Difference|-4.7|||||TWO_SIDED|95.0|-13.5|4.1||||||Overall response for participants with AP||4.1|-13.5|
72517730|NCT03788967|144564862|OTHER||Risk Difference|-1.6|||||TWO_SIDED|95.0|-11.0|7.7||||||Overall response in participants with cUTI||7.7|-11.0|
72517731|NCT03788967|144564863|OTHER||Risk Difference|1.4|||||TWO_SIDED|95.0|-7.2|9.9||||||||9.9|-7.2|
72517732|NCT03788967|144564863|OTHER||Risk Difference (RD)|-8.4|||||TWO_SIDED|95.0|-20.6|3.8||||||≥65 to \<75 years||3.8|-20.6|
72517733|NCT03788967|144564863|OTHER||Risk Difference (RD)|-7.5|||||TWO_SIDED|95.0|-23.8|8.7||||||≥75 years||8.7|-23.8|
72517734|NCT03788967|144564864|OTHER||Risk Difference|-3.1|||||TWO_SIDED|95.0|-9.6|3.5||||||Central and Eastern Europe||3.5|-9.6|
72517735|NCT03788967|144564865|OTHER|||||||0.044|||||||Log Rank|||||||0.044
72624810|NCT01346592|144778966|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (B strain)|0.71|||||TWO_SIDED|95.0|0.23|2.16||||||At risk subjects.||2.16|0.23|
72492071|NCT03988335|144512806|OTHER|The primary endpoints were first tested at alpha of 10% (2-sided). If the larger p-value was less than 10% (2-sided), both primary endpoints were to be declared statistically significant. If the larger p-value was greater than 10%, but the smaller p-value was less than 5% (2-sided), then the primary endpoint with the smaller p-value was to be declared statistically significant.||||||0.24|||||||Hochberg's method|||||||0.24
72517736|NCT03788967|144564866|OTHER|||||||0.736|||||||Log Rank|||||||0.736
72517737|NCT00962754|144564886|NON_INFERIORITY_OR_EQUIVALENCE|non-inferiority since our hypothesis was that there would be no difference in outcome between the intervention and the control group.|Adjusted ratio of geometric means|1.0|||<|0.05|TWO_SIDED|95.0|0.81|1.19||"log transformation of mean duration of hospitalization,difference between two groups expressed as ratio of geometric means for duration. 95% confidence intervals calculated using bootstrapping method.~correction by linear regression model"|t-test, 2 sided|||We calculated that 85 patients in each group would give a power in excess of 85% to detect a difference of two days or more in the geometric mean length of hospital stay with a two-sided significance level of 0.05.||1.19|0.81|<0.05
72492072|NCT03988335|144512807|OTHER|The primary endpoints were first tested at alpha of 10% (2-sided). If the larger p-value was less than 10% (2sided), both primary endpoints were to be declared statistically significant. If the larger p-value was greater than 10%, but the smaller p-value was less than 5% (2-sided), then the primary endpoint with the smaller p-value was to be declared statistically significant.||||||0.804|||||||Hochberg's method|||||||0.804
72492073|NCT01827670|144512824|SUPERIORITY_OR_OTHER||Adjusted Mean|-1.29|||<|0.0001|TWO_SIDED|95.0|-1.53|-1.06|||ANCOVA|From ANCOVA model: Treatment as fixed factor \& baseline Schiff score as covariate.|Difference was 0.454% stannous fluoride minus 0.76% sodium monofluorophosphate such that a negative difference favours first named treatment.|"The principal null hypothesis tested was as follows:~H0: The change from baseline was same for both treatments. H1: The change from baseline was different for both the treatments"||-1.06|-1.53|<0.0001
72492074|NCT01827670|144512825|SUPERIORITY_OR_OTHER||Adjusted Mean|-0.81|||<|0.0001|TWO_SIDED|95.0|-1.0|-0.62|||ANCOVA|From ANCOVA model: Treatment as fixed factor \& baseline Schiff score as covariate.|Difference was 0.454% Stannous Fluoride minus 0.76% Sodium MonoFluorophosphate such that a negative difference favored first named treatment|"The principal null hypothesis tested was as follows:~H0: The change from baseline was same for both treatments. H1: The change from baseline was different for both the treatments"||-0.62|-1.00|<0.0001
72569423|NCT00444457|144669744|SUPERIORITY_OR_OTHER||Difference in log-transformed GM|-0.03|||||TWO_SIDED|95.0|-0.18|0.11|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Common serotypes - serotype 19F||0.11|-0.18|
72569424|NCT00444457|144669744|SUPERIORITY_OR_OTHER||Difference in log-transformed GM|-0.37|||||TWO_SIDED|95.0|-0.51|-0.22|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Common serotypes - serotype 19F||-0.22|-0.51|
72624811|NCT01346592|144778969|SUPERIORITY_OR_OTHER||GMT ratio (H1N1 strain)|4.07|||||TWO_SIDED|95.0|3.34|4.95||||||GMTs were considered to be statistically significantly higher if the lower bound of the 95% confidence interval around the vaccine group ratio was \>1.0||4.95|3.34|
72492075|NCT01827670|144512826|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|27.2|||<|0.0001|TWO_SIDED|95.0|19.4|35.1|||ANCOVA|From ANCOVA model: Treatment and baseline Schiff stratification value as fixed factor and baseline tactile threshold as covariate|Difference was 0.454% Stannous Fluoride minus 0.76% Sodium MonoFluorophosphate such that a positive difference favours first named treatment.|"The principal null hypothesis tested was as follows:~H0: The change from baseline was same for both treatments. H1: The change from baseline was different for both the treatments"||35.1|19.4|<0.0001
72492076|NCT01827670|144512827|SUPERIORITY_OR_OTHER||Adjusted Mean|7.5||||0.0138|TWO_SIDED|95.0|1.6|13.4|||ANCOVA|From ANCOVA model: Treatment and baseline Schiff stratification value as fixed factor and baseline tactile threshold as covariate|Difference was 0.454% Stannous Fluoride minus 0.76% Sodium MonoFluorophosphate such that a positive difference favours first named treatment.|"The principal null hypothesis tested was as follows:~H0: The change from baseline was same for both treatments. H1: The change from baseline was different for both the treatments"||13.4|1.6|0.0138
72492077|NCT01827670|144512828|SUPERIORITY_OR_OTHER||Adjusted Mean|-12.14||||0.0003|TWO_SIDED|95.0|-18.51|-5.77|||ANCOVA|From ANCOVA model: Treatment and baseline Schiff stratification value as fixed factor and baseline VAS as covariate.|Difference was 0.454% Stannous Fluoride minus 0.76% Sodium MonoFluorophosphate such that a negative difference favored first named treatment|"The principal null hypothesis tested was as follows:~H0: The change from baseline was same for both treatments. H1: The change from baseline was different for both the treatments"||-5.77|-18.51|0.0003
72492078|NCT01827670|144512829|SUPERIORITY_OR_OTHER||Adjusted Mean|-21.82|||<|0.0001|TWO_SIDED|95.0|-29.55|-14.09|||ANCOVA|From ANCOVA model: Treatment and baseline Schiff stratification value as fixed factor and baseline VAS as covariate.|Difference was 0.454% Stannous Fluoride minus 0.76% Sodium MonoFluorophosphate such that a negative difference favored first named treatment|"The principal null hypothesis tested was as follows:~H0: The change from baseline was same for both treatments. H1: The change from baseline was different for both the treatments."||-14.09|-29.55|<0.0001
72492079|NCT03594227|144512849|SUPERIORITY||Mean Difference (Net)|-19.26|STANDARD_ERROR_OF_MEAN|5.02||0.011|TWO_SIDED|95.0|-33.98|-4.54||All statistical testing was two-sided and performed using a significance (alpha) level of 0.05.|Mixed Models Analysis|||The planned sample size is approximately 95 enrolled subjects with approximately 45 subjects enrolled with AT or AU. Because the primary efficacy analysis of mean percent reduction in hair loss using SALT scores is expected to be more sensitive than the SALT50 responder analysis, the power for the primary analysis is also expected to be no less than 80%.||-4.54|-33.98|0.011
72492080|NCT03594227|144512849|SUPERIORITY||Mean Difference (Final Values)|-24.08|STANDARD_ERROR_OF_MEAN|5.02||0.001|TWO_SIDED|95.0|-38.8|-9.36||All statistical testing was two-sided and performed using a significance (alpha) level of 0.05.|Mixed Models Analysis|||The planned sample size is approximately 95 enrolled subjects with approximately 45 subjects enrolled with AT or AU. Because the primary efficacy analysis of mean percent reduction in hair loss using SALT scores is expected to be more sensitive than the SALT50 responder analysis, the power for the primary analysis is also expected to be no less than 80%.||-9.36|-38.80|0.001
72492081|NCT03594227|144512849|SUPERIORITY||Mean Difference (Final Values)|-19.54|STANDARD_ERROR_OF_MEAN|5.133||0.01|TWO_SIDED|95.0|-34.41|-4.67||All statistical testing was two-sided and performed using a significance (alpha) level of 0.05.|Mixed Models Analysis|||The planned sample size is approximately 95 enrolled subjects with approximately 45 subjects enrolled with AT or AU. Because the primary efficacy analysis of mean percent reduction in hair loss using SALT scores is expected to be more sensitive than the SALT50 responder analysis, the power for the primary analysis is also expected to be no less than 80%.||-4.67|-34.41|0.010
72492082|NCT03594227|144512850|SUPERIORITY||Mean Difference (Final Values)|-19.17|STANDARD_ERROR_OF_MEAN|5.165||0.013|TWO_SIDED|95.0|-34.33|-4.02|||Mixed Models Analysis|||||-4.02|-34.33|0.013
72492083|NCT03594227|144512850|SUPERIORITY||Mean Difference (Net)|-24.53|STANDARD_ERROR_OF_MEAN|5.165||0.002|TWO_SIDED|95.0|-39.69|-9.38|||Mixed Models Analysis|||||-9.38|-39.69|0.002
72492084|NCT03594227|144512850|SUPERIORITY||Mean Difference (Net)|-19.17|STANDARD_ERROR_OF_MEAN|5.281||0.014|TWO_SIDED|95.0|-34.48|-3.86|||Mixed Models Analysis|||||-3.86|-34.48|0.014
72492085|NCT03594227|144512851|SUPERIORITY||Mean Difference (Net)|-11.29|STANDARD_ERROR_OF_MEAN|3.359||0.025|TWO_SIDED|95.0|-21.14|-1.45|||Mixed Models Analysis|||||-1.45|-21.14|0.025
72492086|NCT03594227|144512851|SUPERIORITY||Mean Difference (Net)|-15.25|STANDARD_ERROR_OF_MEAN|3.359||0.003|TWO_SIDED|95.0|-25.1|-5.4|||Mixed Models Analysis|||||-5.40|-25.10|0.003
72492087|NCT03594227|144512851|SUPERIORITY||Mean Difference (Net)|-17.55|STANDARD_ERROR_OF_MEAN|3.434|<|0.001|TWO_SIDED|95.0|-27.49|-7.6|||Mixed Models Analysis|||||-7.60|-27.49|<0.001
72492088|NCT03594227|144512852|SUPERIORITY||Mean Difference (Net)|-14.4|STANDARD_ERROR_OF_MEAN|3.599||0.008|TWO_SIDED|95.0|-24.95|-3.84|||Mixed Models Analysis|||||-3.84|-24.95|0.008
72569425|NCT00444457|144669744|SUPERIORITY_OR_OTHER||Difference in log-transformed GM|-0.33|||||TWO_SIDED|95.0|-0.47|-0.2|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Common serotypes - serotype 19F||-0.20|-0.47|
72517738|NCT00132314|144564889|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.87||||0.39|TWO_SIDED|95.0|0.63|1.2|||Log Rank|||Time-to-event analysis; The primary outcome hypothesis is tested using a two-sided log-rank test to compare the hazard rate for the IM treatment group to that for the oral treatment group.||1.20|0.63|0.39
72624812|NCT01346592|144778969|SUPERIORITY_OR_OTHER||GMT ratio (H3N2 strain)|1.95|||||TWO_SIDED|95.0|1.74|2.18||||||statistically significantly greater response was concluded if the lower bound of the 95% confidence interval around the vaccine group ratio is \>1.0||2.18|1.74|
72492089|NCT03594227|144512852|SUPERIORITY||Mean Difference (Net)|-19.01|STANDARD_ERROR_OF_MEAN|3.599|<|0.001|TWO_SIDED|95.0|-29.56|-8.45|||Mixed Models Analysis|||||-8.45|-29.56|<0.001
72492090|NCT03594227|144512852|SUPERIORITY||Mean Difference (Net)|-17.52|STANDARD_ERROR_OF_MEAN|3.679||0.001|TWO_SIDED|95.0|-28.18|-6.86|||Mixed Models Analysis|||||-6.86|-28.18|0.001
72492091|NCT03594227|144512853|SUPERIORITY||Odds Ratio (OR)|4.6||||0.124|TWO_SIDED|95.0|0.7|31.8|||Mixed Models Analysis|||||31.8|0.7|0.124
72492092|NCT03594227|144512853|SUPERIORITY||Mean Difference (Final Values)|5.6||||0.079|TWO_SIDED|95.0|0.8|38.3|||Mixed Models Analysis|||||38.3|0.8|0.079
72492093|NCT03594227|144512853|SUPERIORITY||Mean Difference (Final Values)|3.9||||0.177|TWO_SIDED|95.0|0.5|27.7|||Mixed Models Analysis|||||27.7|0.5|0.177
72492094|NCT03594227|144512854|SUPERIORITY||Odds Ratio (OR)|4.6||||0.124|TWO_SIDED|95.0|0.7|31.8|||Mixed Models Analysis|||||31.8|0.7|0.124
72492095|NCT03594227|144512854|SUPERIORITY||Odds Ratio (OR)|5.6||||0.079|TWO_SIDED|95.0|0.8|38.3|||Mixed Models Analysis|||||38.3|0.8|0.079
72492096|NCT03594227|144512854|SUPERIORITY||Odds Ratio (OR)|3.9||||0.177|TWO_SIDED|95.0|0.5|27.7|||Mixed Models Analysis|||||27.7|0.5|0.177
72492097|NCT03594227|144512855|SUPERIORITY|||||||0.471|||||||Wilcoxon (Mann-Whitney)|||||||0.471
72492098|NCT03594227|144512855|SUPERIORITY|||||||0.457|||||||Wilcoxon (Mann-Whitney)|||||||0.457
72492099|NCT03594227|144512855|SUPERIORITY|||||||0.367|||||||Wilcoxon (Mann-Whitney)|||||||0.367
72492100|NCT03594227|144512856|SUPERIORITY|||||||0.187|||||||Wilcoxon (Mann-Whitney)|||||||0.187
72492101|NCT03594227|144512856|SUPERIORITY|||||||0.375|||||||Wilcoxon (Mann-Whitney)|||||||0.375
72492102|NCT03594227|144512856|SUPERIORITY|||||||0.581|||||||Wilcoxon (Mann-Whitney)|||||||0.581
72492103|NCT03594227|144512857|SUPERIORITY|||||||0.444|||||||Wilcoxon (Mann-Whitney)|||||||0.444
72492104|NCT03594227|144512857|SUPERIORITY|||||||0.861|||||||Wilcoxon (Mann-Whitney)|||||||0.861
72492105|NCT03594227|144512857|SUPERIORITY|||||||0.182|||||||Wilcoxon (Mann-Whitney)|||||||0.182
72492106|NCT03594227|144512858|SUPERIORITY|||||||0.258|||||||Wilcoxon (Mann-Whitney)|||||||0.258
72492107|NCT03594227|144512858|SUPERIORITY|||||||0.263|||||||Wilcoxon (Mann-Whitney)|||||||0.263
72492108|NCT03594227|144512858|SUPERIORITY|||||||0.101|||||||Wilcoxon (Mann-Whitney)|||||||0.101
72492109|NCT03594227|144512859|SUPERIORITY||||||>|0.999|||||||Wilcoxon (Mann-Whitney)|||||||>0.999
72492110|NCT03594227|144512859|SUPERIORITY|||||||0.277|||||||Wilcoxon (Mann-Whitney)|||||||0.277
72492111|NCT03594227|144512859|SUPERIORITY|||||||0.159|||||||Wilcoxon (Mann-Whitney)|||||||0.159
72492112|NCT03594227|144512860|SUPERIORITY|||||||0.407|||||||Wilcoxon (Mann-Whitney)|||||||0.407
72492113|NCT03594227|144512860|SUPERIORITY|||||||0.894|||||||Wilcoxon (Mann-Whitney)|||||||0.894
72492114|NCT03594227|144512860|SUPERIORITY|||||||0.179|||||||Wilcoxon (Mann-Whitney)|||||||0.179
72492115|NCT03594227|144512861|SUPERIORITY|||||||0.691|||||||Wilcoxon (Mann-Whitney)|||||||0.691
72492116|NCT03594227|144512861|SUPERIORITY|||||||0.521|||||||Wilcoxon (Mann-Whitney)|||||||0.521
72492117|NCT03594227|144512861|SUPERIORITY|||||||0.262|||||||Wilcoxon (Mann-Whitney)|||||||0.262
72492118|NCT03594227|144512862|SUPERIORITY|||||||0.009|||||||Wilcoxon (Mann-Whitney)|||||||0.009
72492119|NCT03594227|144512862|SUPERIORITY|||||||0.154|||||||Wilcoxon (Mann-Whitney)|||||||0.154
72492120|NCT03594227|144512862|SUPERIORITY|||||||0.289|||||||Wilcoxon (Mann-Whitney)|||||||0.289
72492121|NCT03594227|144512863|SUPERIORITY|||||||0.073|||||||Wilcoxon (Mann-Whitney)|||||||0.073
72492122|NCT03594227|144512863|SUPERIORITY|||||||0.66|||||||Wilcoxon (Mann-Whitney)|||||||0.660
72492123|NCT03594227|144512863|SUPERIORITY|||||||0.704|||||||Wilcoxon (Mann-Whitney)|||||||0.704
72492124|NCT03594227|144512864|SUPERIORITY||||||>|0.999|||||||Wilcoxon (Mann-Whitney)|||||||>0.999
72492125|NCT03594227|144512864|SUPERIORITY|||||||0.911|||||||Wilcoxon (Mann-Whitney)|||||||0.911
72492126|NCT03594227|144512864|SUPERIORITY|||||||0.11|||||||Wilcoxon (Mann-Whitney)|||||||0.110
72492127|NCT03594227|144512865|SUPERIORITY|||||||0.43|||||||Wilcoxon (Mann-Whitney)|||||||0.430
72492128|NCT03594227|144512865|SUPERIORITY|||||||0.288|||||||Wilcoxon (Mann-Whitney)|||||||0.288
72492129|NCT03594227|144512865|SUPERIORITY|||||||0.582|||||||Wilcoxon (Mann-Whitney)|||||||0.582
72492130|NCT03594227|144512866|SUPERIORITY|||||||0.194|||||||Wilcoxon (Mann-Whitney)|||||||0.194
72492131|NCT03594227|144512866|SUPERIORITY||||||>|0.999|||||||Wilcoxon (Mann-Whitney)|||||||>0.999
72492132|NCT03594227|144512866|SUPERIORITY|||||||0.011|||||||Wilcoxon (Mann-Whitney)|||||||0.011
72492133|NCT03594227|144512867|SUPERIORITY|||||||0.248|||||||Wilcoxon (Mann-Whitney)|||||||0.248
72492134|NCT03594227|144512867|SUPERIORITY|||||||0.15|||||||Wilcoxon (Mann-Whitney)|||||||0.150
72492135|NCT03594227|144512867|SUPERIORITY|||||||0.546|||||||Wilcoxon (Mann-Whitney)|||||||0.546
72492136|NCT03594227|144512868|SUPERIORITY|||||||0.341|||||||Wilcoxon (Mann-Whitney)|||||||0.341
72492137|NCT03594227|144512868|SUPERIORITY||||||>|0.999|||||||Wilcoxon (Mann-Whitney)|||||||>0.999
72492138|NCT03594227|144512868|SUPERIORITY|||||||0.068|||||||Wilcoxon (Mann-Whitney)|||||||0.068
72492139|NCT03594227|144512870|SUPERIORITY|||||||0.098|||||||Wilcoxon (Mann-Whitney)|||||||0.098
72492140|NCT03594227|144512870|SUPERIORITY|||||||0.082|||||||Wilcoxon (Mann-Whitney)|||||||0.082
72492141|NCT03594227|144512870|SUPERIORITY|||||||0.313|||||||Wilcoxon (Mann-Whitney)|||||||0.313
72492142|NCT03594227|144512871|SUPERIORITY|||||||0.883|||||||Wilcoxon (Mann-Whitney)|||||||0.883
72492143|NCT03594227|144512871|SUPERIORITY|||||||0.954|||||||Wilcoxon (Mann-Whitney)|||||||0.954
72492144|NCT03594227|144512871|SUPERIORITY|||||||0.295|||||||Wilcoxon (Mann-Whitney)|||||||0.295
72492145|NCT03594227|144512872|SUPERIORITY|||||||0.361|||||||Wilcoxon (Mann-Whitney)|||||||0.361
72492146|NCT03594227|144512872|SUPERIORITY|||||||0.182|||||||Wilcoxon (Mann-Whitney)|||||||0.182
72492147|NCT03594227|144512872|SUPERIORITY|||||||0.815|||||||Wilcoxon (Mann-Whitney)|||||||0.815
72492148|NCT03594227|144512873|SUPERIORITY|||||||0.522|||||||Wilcoxon (Mann-Whitney)|||||||0.522
72569426|NCT00444457|144669744|SUPERIORITY_OR_OTHER||Difference in log-transformed GM|-0.03|||||TWO_SIDED|95.0|-0.17|0.11|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Common serotypes - serotype 23F||0.11|-0.17|
72492149|NCT03594227|144512873|SUPERIORITY|||||||0.104|||||||Wilcoxon (Mann-Whitney)|||||||0.104
72492150|NCT03594227|144512873|SUPERIORITY|||||||0.414|||||||Wilcoxon (Mann-Whitney)|||||||0.414
72492151|NCT03594227|144512874|SUPERIORITY||Mean Difference (Net)|0.21|STANDARD_ERROR_OF_MEAN|0.93||0.882|TWO_SIDED|95.0|-2.53|2.94|||Mixed Models Analysis|||||2.94|-2.53|0.882
72492152|NCT03594227|144512874|SUPERIORITY||Mean Difference (Net)|-3.58|STANDARD_ERROR_OF_MEAN|0.93||0.011|TWO_SIDED|95.0|-6.31|-0.84|||Mixed Models Analysis|||||-0.84|-6.31|0.011
72492153|NCT03594227|144512874|SUPERIORITY||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|0.951||0.999|TWO_SIDED|95.0|-2.76|2.76|||Mixed Models Analysis|||||2.76|-2.76|0.999
72492154|NCT03594227|144512875|SUPERIORITY|||||||0.27|||||||Wilcoxon (Mann-Whitney)|||||||0.270
72492155|NCT03594227|144512875|SUPERIORITY|||||||0.319|||||||Wilcoxon (Mann-Whitney)|||||||0.319
72492156|NCT03594227|144512875|SUPERIORITY|||||||0.094|||||||Wilcoxon (Mann-Whitney)|||||||0.094
72492157|NCT03594227|144512876|SUPERIORITY|||||||0.584|||||||Wilcoxon (Mann-Whitney)|||||||0.584
72492158|NCT03594227|144512876|SUPERIORITY|||||||0.287|||||||Wilcoxon (Mann-Whitney)|||||||0.287
72492159|NCT03594227|144512876|SUPERIORITY|||||||0.144|||||||Wilcoxon (Mann-Whitney)|||||||0.144
72492160|NCT03594227|144512877|SUPERIORITY|||||||0.341|||||||Wilcoxon (Mann-Whitney)|||||||0.341
72492161|NCT03594227|144512877|SUPERIORITY|||||||0.203|||||||Wilcoxon (Mann-Whitney)|||||||0.203
72492162|NCT03594227|144512877|SUPERIORITY|||||||0.327|||||||Wilcoxon (Mann-Whitney)|||||||0.327
72492163|NCT03594227|144512878|SUPERIORITY|||||||0.827|||||||Wilcoxon (Mann-Whitney)|||||||0.827
72492164|NCT03594227|144512878|SUPERIORITY|||||||0.742|||||||Wilcoxon (Mann-Whitney)|||||||0.742
72492165|NCT03594227|144512878|SUPERIORITY|||||||0.462|||||||Wilcoxon (Mann-Whitney)|||||||0.462
72492166|NCT03594227|144512879|SUPERIORITY|||||||0.836|||||||Wilcoxon (Mann-Whitney)|||||||0.836
72492167|NCT03594227|144512879|SUPERIORITY|||||||0.54|||||||Wilcoxon (Mann-Whitney)|||||||0.540
72492168|NCT03594227|144512879|SUPERIORITY|||||||0.672|||||||Wilcoxon (Mann-Whitney)|||||||0.672
72492169|NCT03594227|144512880|SUPERIORITY|||||||0.469|||||||Wilcoxon (Mann-Whitney)|||||||0.469
72492170|NCT03594227|144512880|SUPERIORITY|||||||0.219|||||||Wilcoxon (Mann-Whitney)|||||||0.219
72492171|NCT03594227|144512880|SUPERIORITY|||||||0.196|||||||Wilcoxon (Mann-Whitney)|||||||0.196
72492172|NCT00790907|144512881|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.8||||0.267|TWO_SIDED|95.0|0.54|1.19|||Regression, Logistic|||||1.19|0.54|0.267
72492173|NCT01888640|144512889|SUPERIORITY||Mean Difference (Final Values)|-1.0||||0.008|TWO_SIDED|95.0|-1.8|-0.2||To account for multiple tests involving pairwise treatment group comparisons, p-values were adjusted using Bonferroni's method|Linear mixed models for repeated measure|||Visit 2-Visit 3||-0.2|-1.8|0.008
72492174|NCT01888640|144512889|SUPERIORITY||Mean Difference (Final Values)|-1.8|||<|0.0001|TWO_SIDED|95.0|-2.6|-1.0|||Linear mixed models for repeated measure|||Visit 2 to Visit 3||-1.0|-2.6|<0.0001
72492175|NCT01888640|144512890|SUPERIORITY||Mean Difference (Net)|-1.3||||0.002|TWO_SIDED|95.0|-2.2|-0.4|||Linear mixed models for repeated measure|||Visit 2 to Visit 3||-0.4|-2.2|0.002
72492176|NCT01888640|144512890|SUPERIORITY||Mean Difference (Final Values)|-1.8|||<|0.0001|TWO_SIDED|95.0|-2.8|-1.0|||Linear mixed models for repeated measure|||Visit 2 to Visit 3||-1.0|-2.8|<0.0001
72492177|NCT01888640|144512891|SUPERIORITY||Mean Difference (Final Values)|-1.2||||0.0006|TWO_SIDED|95.0|-2.1|-0.4|||Linear mixed models for repeated measure|||Visit 2 to Visit 3||-0.4|-2.1|0.0006
72492178|NCT01888640|144512891|SUPERIORITY||Mean Difference (Final Values)|-1.4|||<|0.0001|TWO_SIDED|95.0|-2.2|-0.6|||Linear mixed models for repeated measure|||Visit 2 to Visit 3||-0.6|-2.2|<0.0001
72492179|NCT01888640|144512892|SUPERIORITY||Mean Difference (Final Values)|-1.4||||0.001|TWO_SIDED|95.0|-2.4|-0.4|||Linear mixed models for repeated measure|||Visit 2 to Visit 3||-0.4|-2.4|0.001
72492180|NCT01888640|144512892|SUPERIORITY||Mean Difference (Final Values)|-1.9|||<|0.0001|TWO_SIDED|95.0|-2.9|-0.9|||Linear mixed models for repeated measure|||Visit 2 to Visit 3||-0.9|-2.9|<0.0001
72492181|NCT01888640|144512893|SUPERIORITY||Mean Difference (Final Values)|-1.2||||0.011|TWO_SIDED|95.0|-2.2|-0.2|||Linear mixed models for repeated measure|||Visit 2 to Visit 3||-0.2|-2.2|0.011
72492182|NCT01888640|144512893|SUPERIORITY||Mean Difference (Final Values)|-2.0|||<|0.0001|TWO_SIDED|95.0|-3.0|-1.0|||Linear mixed models for repeated measure|||Visit 2 to Visit 3||-1.0|-3.0|<0.0001
72492183|NCT01888640|144512894|SUPERIORITY||Mean Difference (Final Values)|-1.2||||0.016|TWO_SIDED|95.0|-2.2|-0.1|||Linear mixed models for repeated measure|||Visit 2 to Visit 3||-0.1|-2.2|0.016
72492184|NCT01888640|144512894|SUPERIORITY||Mean Difference (Final Values)|-1.57||||0.0002|TWO_SIDED|95.0|-2.6|-0.6|||Linear mixed models for repeated measure|||Visit 2 to Visit 3||-0.6|-2.6|0.0002
72492185|NCT01888640|144512895|SUPERIORITY||Mean Difference (Final Values)|-5.0||||0.074|TWO_SIDED|95.0|-10.4|0.3|||Linear mixed models for repeated measure|||Visit 2 to Visit 3||0.3|-10.4|0.074
72492186|NCT01888640|144512895|SUPERIORITY||Mean Difference (Final Values)|-7.1||||0.005|TWO_SIDED|95.0|-12.4|-1.8|||Linear mixed models for repeated measure|||Visit 2 to Visit 3||-1.8|-12.4|0.005
72492187|NCT01888640|144512896|SUPERIORITY||Mean Difference (Final Values)|-0.9||||0.018|TWO_SIDED|95.0|-1.7|-0.1|||Linear mixed models for repeated measure|||Visit 2 to Visit 3||-0.1|-1.7|0.018
72492188|NCT01888640|144512896|SUPERIORITY||Mean Difference (Final Values)|-1.2||||0.0006|TWO_SIDED|95.0|-1.9|-0.4|||Linear mixed models for repeated measure|||Visit 2 to Visit 3||-0.4|-1.9|0.0006
72492189|NCT01888640|144512897|SUPERIORITY||Mean Difference (Final Values)|-0.7||||0.043|TWO_SIDED|95.0|-1.3|-0.01|||Linear mixed models for repeated measure|||Visit 2 to Visit 3||-0.01|-1.3|0.043
72492190|NCT01888640|144512897|SUPERIORITY||Mean Difference (Final Values)|-0.6||||0.048|TWO_SIDED|95.0|-1.3|0.0|||Linear mixed models for repeated measure|||Visit 2 to Visit 3||-0.0|-1.3|0.048
72569427|NCT00444457|144669744|SUPERIORITY_OR_OTHER||Difference in log-transformed GM|0.08|||||TWO_SIDED|95.0|-0.07|0.22|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Common serotypes - serotype 23F||0.22|-0.07|
72569428|NCT00444457|144669744|SUPERIORITY_OR_OTHER||Difference in log-transformed GM|0.11|||||TWO_SIDED|95.0|-0.03|0.25|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Common serotypes - serotype 23F||0.25|-0.03|
72569429|NCT00444457|144669744|SUPERIORITY_OR_OTHER||Difference in log-transformed GM|-0.07|||||TWO_SIDED|95.0|-0.2|0.06|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Additional serotypes - serotype 1||0.06|-0.20|
72569430|NCT00444457|144669744|SUPERIORITY_OR_OTHER||Difference in log-transformed GM|-0.09|||||TWO_SIDED|95.0|-0.21|0.03|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Additional serotypes - serotype 1||0.03|-0.21|
72569431|NCT00444457|144669744|SUPERIORITY_OR_OTHER||Difference in log-transformed GM|-0.02|||||TWO_SIDED|95.0|-0.15|0.11|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Additional serotypes - serotype 1||0.11|-0.15|
72569432|NCT00444457|144669744|SUPERIORITY_OR_OTHER||Difference in log-transformed GM|0.06|||||TWO_SIDED|95.0|-0.06|0.18|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Additional serotypes - serotype 3||0.18|-0.06|
72569433|NCT00444457|144669744|SUPERIORITY_OR_OTHER||Difference in log-transformed GM|-0.07|||||TWO_SIDED|95.0|-0.18|0.04|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Additional serotypes - serotype 3||0.04|-0.18|
72624813|NCT01346592|144778969|SUPERIORITY_OR_OTHER||GMT ratio (B strain)|2.03|||||TWO_SIDED|95.0|1.73|2.39||||||statistically significantly greater response was concluded if the lower bound of the 95% CI around the vaccine group ratio was \>1.0||2.39|1.73|
72517739|NCT00132314|144564890|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.87|||||TWO_SIDED|95.0|0.63|1.2||95% Confidence Interval: 0.63 to 1.20|Regression, Cox|||||1.20|0.63|
72517740|NCT00093470|144564897|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.76||||0.026|TWO_SIDED|95.0|0.538|1.072||one-sided p-value; threshold for statistical significance \<0.025|Log Rank|stratified log rank test|Hazard ratio of DFS for Arm A to Arm B|||1.072|0.538|0.026
72517741|NCT00093470|144564898|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.809||||0.056|TWO_SIDED|95.0|0.567|1.155||one-sided p-value; threshold for statistical significance \< 0.025|Log Rank|stratified log rank test|Hazard ratio of OS for Arm A to Arm B|||1.155|0.567|0.056
72517742|NCT02514772|144564911|OTHER||Difference (%)|-1.9|||||TWO_SIDED|95.0|-20.6|16.9||||||||16.9|-20.6|
72517743|NCT02514772|144564912|OTHER||Difference (%)|-1.7|||||TWO_SIDED|95.0|-20.6|16.9||||||||16.9|-20.6|
72517744|NCT02514772|144564913|OTHER||Difference (%)|-1.9|||||TWO_SIDED|95.0|-21.2|17.6||||||||17.6|-21.2|
72517745|NCT02514772|144564914|OTHER||Mean Difference (Final Values)|-5.4|||||TWO_SIDED|95.0|-24.2|13.3||||||Incidence difference of infusion-related reactions, occurred on day of or on day after first infusion (i.e. on study day 1 or on study day 2).||13.3|-24.2|
72624814|NCT01346592|144778969|SUPERIORITY_OR_OTHER||GMT ratio (H1N1 strain)|3.82||||||95.0|3.14|4.64||||||statistically significantly greater response was concluded if the lower bound of the 95% CI around the vaccine group ratio was \>1.0||4.64|3.14|
72624815|NCT01346592|144778969|SUPERIORITY_OR_OTHER||GMT ratio (H3N2 strain)|2.4|||||TWO_SIDED|95.0|2.15|2.68||||||statistically significantly greater response was concluded if the lower bound of the 95% CI around the vaccine group ratio was \>1.0||2.68|2.15|
72624816|NCT01346592|144778969|SUPERIORITY_OR_OTHER||GMT ratio (B strain)|1.95|||||TWO_SIDED|95.0|1.65|2.29||||||statistically significantly greater response was concluded if the lower bound of the 95% CI around the vaccine group ratio was \>1.0||2.29|1.65|
72517746|NCT02514772|144564914|OTHER||Mean Difference (Final Values)|-5.3|||||TWO_SIDED|95.0|-24.5|13.6||||||Incidence difference of infusion-related reactions, occurred on day of or on day after second infusion (i.e. on study day 14 or on study day 15).||13.6|-24.5|
72517747|NCT02514772|144564914|OTHER||Mean Difference (Final Values)|-7.2|||||TWO_SIDED|95.0|-26.0|11.4||||||Incidence difference of infusion-related reactions overall on day(s) of or day(s) after either infusion (i.e. on day 1 or 2 and on day 14 or day 15).||11.4|-26.0|
72517748|NCT02034552|144564938|SUPERIORITY|||||||0.0109||||||\[80% CI\]: \[10.1%- 39.6%\]|Clopper and Pearson|Patient bone scan response rate at Week 24 will be estimated with exact binomial 80% CI using the method of Clopper and Pearson.||H0: Patient bone scan response rate at Week 24 ≤5%. The Type I error rate for the test in each treatment group, is one-sided 0.10. A one-sided p-value will be reported for this test.||||0.0109
72569434|NCT00444457|144669744|SUPERIORITY_OR_OTHER||Difference in log-transformed GM|-0.13|||||TWO_SIDED|95.0|-0.25|-0.01|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Additional serotypes - serotype 3||-0.01|-0.25|
72569435|NCT00444457|144669744|SUPERIORITY_OR_OTHER||Difference in log-transformed GM|0.17|||||TWO_SIDED|95.0|0.05|0.28|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Additional serotypes - serotype 5||0.28|0.05|
72569436|NCT00444457|144669744|SUPERIORITY_OR_OTHER||Difference in log-transformed GM|0.1|||||TWO_SIDED|95.0|0.0|0.21|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Additional serotypes - serotype 5||0.21|-0.00|
72569437|NCT00444457|144669744|SUPERIORITY_OR_OTHER||Difference in log-transformed GM|-0.06|||||TWO_SIDED|95.0|-0.17|0.05|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Additional serotypes - serotype 5||0.05|-0.17|
72569438|NCT00444457|144669744|SUPERIORITY_OR_OTHER||Difference in log-transformed GM|0.08|||||TWO_SIDED|95.0|-0.04|0.19|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Additional serotypes - serotype 6A||0.19|-0.04|
72492191|NCT01888640|144512898|SUPERIORITY||Mean Difference (Final Values)|-0.5||||0.036|TWO_SIDED|95.0|-1.0|0.0|||Linear mixed models for repeated measure|||Visit 2 to Visit 3||-0.0|-1.0|0.036
72492192|NCT01888640|144512898|SUPERIORITY||Mean Difference (Final Values)|-0.9|||<|0.0001|TWO_SIDED|95.0|-1.4|-0.4|||Linear mixed models for repeated measure|||Visit 2 to Visit 3||-0.4|-1.4|<0.0001
72517749|NCT02034552|144564938|SUPERIORITY||||||<|0.0001||||||\[80% CI\]: \[40.8% - 73.7%\]|Clopper and Pearson|Patient bone scan response rate at Week 24 will be estimated with exact binomial 80% CI using the method of Clopper and Pearson.||H0: Patient bone scan response rate at Week 24 ≤5%. The Type I error rate for the test in each treatment group, is one-sided 0.10. A one-sided p-value will be reported for this test.||||<0.0001
72492193|NCT01888640|144512899|SUPERIORITY||Mean Difference (Final Values)|-0.4|||>|0.99|TWO_SIDED|95.0|-2.3|1.5|||Linear mixed models for repeated measure|||Visit 2 to Visit 3||1.5|-2.3|>0.99
72492194|NCT01888640|144512899|SUPERIORITY||Mean Difference (Final Values)|-0.6|||>|0.99|TWO_SIDED|95.0|-2.4|1.3|||Linear mixed models for repeated measure|||Visit 2 to Visit 3||1.3|-2.4|>0.99
72492195|NCT01888640|144512900|SUPERIORITY||Mean Difference (Final Values)|1.1|||>|0.99|TWO_SIDED|95.0|-1.9|4.1|||Linear mixed models for repeated measure|||Visit 2 to Visit 3||4.1|-1.9|>0.99
72492196|NCT01888640|144512900|SUPERIORITY||Mean Difference (Final Values)|2.4||||0.17|TWO_SIDED|95.0|-0.6|5.3|||Linear mixed models for repeated measure|||||5.3|-0.6|0.17
72492197|NCT01888640|144512901|SUPERIORITY||Mean Difference (Final Values)|1.2||||0.36|TWO_SIDED|95.0|-0.7|3.1|||Linear mixed models for repeated measure|||Visit 2 to Visit 3||3.1|-0.7|0.36
72492198|NCT01888640|144512901|SUPERIORITY||Mean Difference (Final Values)|1.0||||0.58|TWO_SIDED|95.0|-0.8|2.8|||Linear mixed models for repeated measure|||Visit 2 to Visit 3||2.8|-0.8|0.58
72492199|NCT01888640|144512902|SUPERIORITY||Mean Difference (Final Values)|19.0|||>|0.99|TWO_SIDED|95.0|-58.0|96.0|||Linear mixed models for repeated measure|||Visit 2 to Visit 3||96|-58|>0.99
72492200|NCT01888640|144512902|SUPERIORITY||Mean Difference (Final Values)|42.0|||>|0.99|TWO_SIDED|95.0|-34.0|117.0|||Linear mixed models for repeated measure|||Visit 2 to Visit 3||117|-34|>0.99
72492201|NCT01888640|144512903|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.96|TWO_SIDED|95.0|-0.2|0.7|||Linear mixed models for repeated measure|||Visit 2 to Visit 3||0.7|-0.2|0.96
72492202|NCT01888640|144512903|SUPERIORITY||Mean Difference (Final Values)|0.6||||0.008|TWO_SIDED|95.0|0.1|1.0|||Linear mixed models for repeated measure|||Visit 2 to Visit 3||1.0|0.1|0.008
72492203|NCT01888640|144512904|SUPERIORITY||||||>|0.99|||||||Linear mixed models for repeated measure|||Visit 2 to Visit 3||||>0.99
72492204|NCT01888640|144512904|SUPERIORITY||||||>|0.99|||||||Linear mixed models for repeated measure|||Visit 2 to Visit 3||||>0.99
72492205|NCT03389854|144512909|SUPERIORITY|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||Control group vs Penile Traction Therapy Group at 3 months||||0.001
72492206|NCT03389854|144512909|SUPERIORITY|||||||0.9|||||||Wilcoxon (Mann-Whitney)|||Control group vs Penile Traction Therapy Group at 6 months||||0.90
72492207|NCT03389854|144512910|SUPERIORITY|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||Control group vs Penile Traction Therapy Group at 3 months||||0.001
72517750|NCT02034552|144564938|SUPERIORITY||||||<|0.0001||||||\[80% CI\]: \[31.8% - 68.2%\]|Clopper and Pearson|Patient bone scan response rate at Week 24 will be estimated with exact binomial 80% CI using the method of Clopper and Pearson.||H0: Patient bone scan response rate at Week 24 ≤5%. The Type I error rate for the test in each treatment group, is one-sided 0.10. A one-sided p-value will be reported for this test.||||<0.0001
72517751|NCT00698035|144564947|SUPERIORITY_OR_OTHER||||||>|0.05||||||Significant at p\<0.05|t-test, 2 sided|||Comparison of baseline estradiol between LC/MS and RIA||||>0.05
72492208|NCT03389854|144512910|SUPERIORITY|||||||0.4|||||||Wilcoxon (Mann-Whitney)|||Control group vs. Penile Traction Therapy Group at 6 months||||0.40
72492209|NCT03389854|144512911|SUPERIORITY|||||||0.01|||||||Wilcoxon (Mann-Whitney)|||Control group vs Penile Traction Therapy Group at 3 months||||0.01
72492210|NCT03389854|144512911|SUPERIORITY|||||||0.64|||||||Wilcoxon (Mann-Whitney)|||Control group vs. Penile Traction Therapy Group at 6 months||||0.64
72492211|NCT03389854|144512912|SUPERIORITY|||||||0.06|||||||Wilcoxon (Mann-Whitney)|||Control group vs Penile Traction Therapy Group at 3 months||||0.06
72492212|NCT03389854|144512912|SUPERIORITY|||||||0.66|||||||Wilcoxon (Mann-Whitney)|||Control group vs Penile Traction Therapy Group at 6 months||||0.66
72492213|NCT03389854|144512913|SUPERIORITY|||||||0.09|||||||Wilcoxon (Mann-Whitney)|||||||0.09
72492214|NCT03389854|144512914|SUPERIORITY|||||||0.26|||||||Wilcoxon (Mann-Whitney)|||||||0.26
72492215|NCT03389854|144512915|SUPERIORITY|||||||0.07|||||||Wilcoxon (Mann-Whitney)|||||||0.07
72492216|NCT00391222|144512968|SUPERIORITY_OR_OTHER|||||||0.057|TWO_SIDED|95.0||||As defined in the protocol, the olanzapine arm was not included in the primary outcome comparison. Data on the olanzapine arm are presented in outcome measure 7.|Log Rank|||Comparison between risperidone LAI and placebo was performed using a log-rank test controlling for patient type at screening (acute or non-acute) and for geographic region. As recurrence rates at 9 months were assumed to be 45% for risperidone LAI and 68% for placebo, the study would have approximately 90% power to detect a clinically meaningful difference of 23% in recurrence rates of a mood episode if in Period III 100 patients were randomized to each of the 2 relevant treatment arms.||||0.057
72492217|NCT00391222|144512969|SUPERIORITY_OR_OTHER|||||||0.005|TWO_SIDED|95.0|||||Log Rank|||The time-to-event data were evaluated by the same survival analysis method as used for the primary outcome. The recurrence rates (Kaplan-Meier estimated) were calculated for each treatment arm using the same methods as for the primary outcome.||||0.005
72492218|NCT00391222|144512969|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Log Rank|||The time-to-event data were evaluated by the same survival analysis method as used for the primary outcome. The recurrence rates (Kaplan-Meier estimated) were calculated for each treatment arm using the same methods as for the primary outcome.||||<0.0001
72492219|NCT00391222|144512970|SUPERIORITY_OR_OTHER|||||||0.655|TWO_SIDED|95.0|||||Log Rank|||The time-to-event data were evaluated by means of the same survival analysis method as used for the primary outcome. The recurrence rates (Kaplan-Meier estimated) were calculated for each treatment arm using the same methods as for the primary outcome.||||0.655
72492220|NCT00391222|144512970|SUPERIORITY_OR_OTHER|||||||0.011|TWO_SIDED|95.0|||||Log Rank|||The time-to-event data were evaluated by means of the same survival analysis method as used for the primary outcome. The recurrence rates (Kaplan-Meier estimated) were calculated for each treatment arm using the same methods as for the primary outcome.||||0.011
72517752|NCT00698035|144564947|SUPERIORITY_OR_OTHER||||||>|0.05||||||singificant at p\<0.05|t-test, 2 sided|||Comparison of week 4 estradiol between LC/MS and RIA||||>0.05
72569439|NCT00444457|144669744|SUPERIORITY_OR_OTHER||Difference in log-transformed GM|0.1|||||TWO_SIDED|95.0|-0.02|0.21|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Additional serotypes - serotype 6A||0.21|-0.02|
72517753|NCT00698035|144564950|SUPERIORITY_OR_OTHER|||||||0.021||||||Significant at p\<0.05|t-test, 2 sided|||Change in SI from BL to W12||||0.021
72517754|NCT00698035|144564950|SUPERIORITY_OR_OTHER||||||<|0.001||||||Significant at p\<0.05|t-test, 2 sided|||Change in SD from BL to W12||||<0.001
72517755|NCT00698035|144564950|SUPERIORITY_OR_OTHER|||||||0.0228||||||Significant at p\<0.05|t-test, 2 sided|||Change in SI from BL to W12||||0.0228
72517756|NCT00698035|144564950|SUPERIORITY_OR_OTHER||||||<|0.001||||||Significant at p\<0.05|t-test, 2 sided|||Change in SD from BL to W12||||<0.001
72517757|NCT00698035|144564951|SUPERIORITY_OR_OTHER|||||||0.004||||||Significant at p\<0.05|t-test, 2 sided|||Change in SS from Baseline to Week 12||||0.004
72517758|NCT00698035|144564951|SUPERIORITY_OR_OTHER|||||||0.139||||||Significant at p\<0.05|t-test, 2 sided|||Change in SS from Baseline to Week 12||||0.139
72517759|NCT00698035|144564952|SUPERIORITY_OR_OTHER||||||<|0.001||||||Significant at p\<0.05|t-test, 2 sided|||Differences in rugae, pallor, petechiae, mucosal thinning and dryness between baseline and week 12||||<0.001
72569440|NCT00444457|144669744|SUPERIORITY_OR_OTHER||Difference in log-transformed GM|0.02|||||TWO_SIDED|95.0|-0.1|0.14|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Additional serotypes - serotype 6A||0.14|-0.10|
72517760|NCT00698035|144564952|SUPERIORITY_OR_OTHER||||||<|0.001||||||Significant at p\<0.05|t-test, 2 sided|||Differences in rugae, pallor, mucosal thinning, and dryness from baseline to 12 weeks||||<0.001
72517761|NCT00698035|144564952|SUPERIORITY_OR_OTHER|||||||0.0061||||||Significant at p\<0.05|t-test, 2 sided|||Difference in petechiae between baseline and week 12||||0.0061
72517762|NCT03807245|144564955|OTHER||||||<|0.0001|||||||ANOVA|||Adjusted geometric mean fold increase from Day 1 to Day 85: adjusted geometric mean ratio GBS-NN/NN2 25mcg/placebo||||<0.0001
72517763|NCT03807245|144564955|OTHER||||||<|0.0001|||||||ANOVA|||Adjusted geometric mean fold increase from Day 1 to Day 85: adjusted geometric mean ratio GBS-NN/NN2 50mcg/placebo||||<0.0001
72517764|NCT00291499|144564958|SUPERIORITY||Mean Difference (Final Values)|-8.7||||0.016|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.016
72517765|NCT00291499|144564959|SUPERIORITY||Mean Difference (Final Values)|-2.14||||0.008|TWO_SIDED||||||t-test, 2 sided|||||||0.008
72517766|NCT00291499|144564960|SUPERIORITY|||||||0.043||||||Threshold p \<0.05|Cochran-Mantel-Haenszel|||||||0.043
72517767|NCT00291499|144564961|SUPERIORITY|||||||0.132||||||Threshold p\<0.05|Wilcoxon (Mann-Whitney)|||||||0.132
72517768|NCT00291499|144564962|SUPERIORITY|||||||0.031||||||Threshold p\<0.05|Wilcoxon (Mann-Whitney)|||||||0.031
72517769|NCT00291499|144564963|SUPERIORITY||Mean Difference (Final Values)|0.363|||<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<0.05
72517770|NCT01082367|144564979|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|21.55|||<|0.001|TWO_SIDED|95.0|4.67|99.52|||Regression, Logistic|||||99.52|4.67|<0.001
72517771|NCT02016898|144564982|OTHER||Risk Ratio (RR)|0.93||||0.7|TWO_SIDED|95.0|0.67|1.29|||Chi-squared|||||1.29|0.67|0.7
72517772|NCT02016898|144564983|OTHER||Median Difference (Final Values)|0.2|STANDARD_DEVIATION|2.01||0.539|TWO_SIDED||||||t-test, 1 sided|||||||0.539
72569441|NCT00444457|144669744|SUPERIORITY_OR_OTHER||Difference in log-transformed GM|0.03|||||TWO_SIDED|95.0|-0.1|0.15|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Additional serotypes - serotype 7F||0.15|-0.10|
72569442|NCT00444457|144669744|SUPERIORITY_OR_OTHER||Difference in log-transformed GM|-0.05|||||TWO_SIDED|95.0|-0.17|0.07|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Additional serotypes - serotype 7F||0.07|-0.17|
72569443|NCT00444457|144669744|SUPERIORITY_OR_OTHER||Difference in log-transformed GM|-0.08|||||TWO_SIDED|95.0|-0.2|0.05|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Additional serotypes - serotype 7F||0.05|-0.20|
72517773|NCT02151682|144565000|NON_INFERIORITY|A logistic regression model was fitted to the response using baseline pain, age group, treatment, and underlying pain condition as explanatory variables, followed by a Farrington-Manning test for non-inferiority, based on Full Analysis Set.|Risk Difference (RD)|-0.06||||0.079|TWO_SIDED|80.0|-0.19|0.06||The p-value is based on Farrington-Manning variance estimator using a pre-specified non-inferiority margin of -0.2. A 1-sided alpha of 0.1 was used. A p-value \<0.1 represents non-inferiority.|Farrington-Manning test|Non-inferiority of tapentadol prolonged-release versus morphine prolonged-release has been demonstrated.|A confidence interval for the risk difference (RD) completely above the pre-specified non-inferiority margin of -0.2 represents non-inferiority of tapentadol prolonged-release versus morphine prolonged-release.|||0.06|-0.19|0.0790
72517774|NCT01306032|144565020|SUPERIORITY_OR_OTHER|||||||0.034|||||||Log Rank|||||||0.034
72517775|NCT01306032|144565020|SUPERIORITY_OR_OTHER|||||||0.68|||||||Log Rank|||||||0.68
72517776|NCT00168064|144565030|NON_INFERIORITY_OR_EQUIVALENCE|The PG formulation was determined to be non-inferior to the AP formulation if the lower limit of the 95% confidence interval around the ratio of the response rates (PG/AP) was \> = 0.75.|ratio of proportions|1.226|||||TWO_SIDED|95.0|0.974|1.552|||ANCOVA||ratio is response rate of PG formulation divided by response rate of AP formulation|||1.552|0.974|
72517777|NCT00318565|144565033|SUPERIORITY_OR_OTHER||Binomial distribution|93.3||||0.05|ONE_SIDED|95.0|90.1||||Exact binomial distribution|||An acute success rate of 88% is anticipated and the one-sided 95% lower confidence bound will be compared to 80%. The statistical hypothesis for the primary efficacy endpoint is evaluated as a one-tailed hypothesis at a = 0.05.|||90.1|.05
72517778|NCT00318565|144565034|SUPERIORITY_OR_OTHER||Binomial Distribution|1.5||||0.05|ONE_SIDED|95.0||7.0|||Exact Binomial Distribution|||The anticipated rate of the CSAE is 2.7% and the one-sided 95% upper confidence bound will be compared to 7%||7||.05
72569444|NCT00444457|144669744|SUPERIORITY_OR_OTHER||Difference in log-transformed GM|0.01|||||TWO_SIDED|95.0|-0.11|0.13|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Additional serotypes - serotype 19A||0.13|-0.11|
72492221|NCT00391222|144512971|SUPERIORITY_OR_OTHER|||||||0.2882|TWO_SIDED|95.0|||||Log Rank|||The time-to-event data were evaluated by means of the same survival analysis method as used for the primary outcome. The recurrence rates (Kaplan-Meier estimated) were calculated for each treatment arm using the same methods as for the primary outcome.||||0.2882
72492222|NCT00391222|144512971|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|95.0|||||Log Rank|||The time-to-event data were evaluated by means of the same survival analysis method as used for the primary outcome. The recurrence rates (Kaplan-Meier estimated) were calculated for each treatment arm using the same methods as for the primary outcome.||||<0.0001
72492223|NCT00391222|144512972|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|95.0|||||ANCOVA|||An ANCOVA model was applied to the change from baseline of Period III at each time point in Period III, with treatment, patient type at screening, and geographic region as factors and baseline YMRS total score as covariate. The comparison between active treatment and placebo was performed based on the LS means obtained from the ANCOVA model. The difference in LS means between treatment arms was estimated, as was the 95% confidence interval for the difference.||||<0.001
72492224|NCT00391222|144512972|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|95.0|||||ANCOVA|||An ANCOVA model was applied to the change from baseline of Period III at each time point in Period III, with treatment, patient type at screening, and geographic region as factors and baseline YMRS total score as covariate. The comparison between active treatment and placebo was performed based on the LS means obtained from the ANCOVA model. The difference in LS means between treatment arms was estimated, as was the 95% confidence interval for the difference.||||<0.001
72492225|NCT00391222|144512973|SUPERIORITY_OR_OTHER|||||||0.48|TWO_SIDED|95.0|||||ANCOVA|||An ANCOVA model was applied to the change from baseline of Period III at each time point in Period III, with treatment, patient type at screening, and geographic region as factors and baseline MADRS total score as covariate. The comparison between active treatment and placebo was performed based on the LS means obtained from the ANCOVA model. The difference in LS means between treatment arms was estimated, as was the 95% confidence interval for the difference.||||0.480
72492226|NCT00391222|144512973|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED|95.0|||||ANCOVA|||An ANCOVA model was applied to the change from baseline of Period III at each time point in Period III, with treatment, patient type at screening, and geographic region as factors and baseline MADRS total score as covariate. The comparison between active treatment and placebo was performed based on the LS means obtained from the ANCOVA model. The difference in LS means between treatment arms was estimated, as was the 95% confidence interval for the difference.||||0.001
72492227|NCT00960843|144512996|SUPERIORITY_OR_OTHER|||||||0.052||95.0|||||t-test, 2 sided|||Null hypothesis was no difference between arms. Original power calculation specified 24 per group and this was achieved under initial randomization. However, due to failure to follow protocol specified adjustment criteria, pressure and weight data from one site had to be excluded.||||0.0520
72492228|NCT00960843|144512997|SUPERIORITY_OR_OTHER|||||||0.0225||95.0|||||t-test, 2 sided|||||||0.0225
72492229|NCT00960843|144512998|SUPERIORITY_OR_OTHER|||||||0.0193||95.0|||||t-test, 2 sided|||||||0.0193
72492230|NCT00652366|144513000|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.26||||0.2026|TWO_SIDED|95.0|0.88|1.8|||Log Rank|||||1.80|0.88|0.2026
72492231|NCT00652366|144513002|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.09||||0.6298|TWO_SIDED|95.0|0.77|1.54|||Log Rank|||||1.54|0.77|0.6298
72492232|NCT00652366|144513003|SUPERIORITY_OR_OTHER||Difference in Response Rates|-6.1||||0.2543|TWO_SIDED|95.0|-17.2|5.0|||Chi-squared||Approximate 95% CI for the difference of two rates was determined using the Hauck-Anderson method.|||5.0|-17.2|0.2543
72492233|NCT00652366|144513003|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.55|||||TWO_SIDED|95.0|0.19|1.56||||||||1.56|0.19|
72492234|NCT00652366|144513005|SUPERIORITY_OR_OTHER||Difference in Disease Control Rates|-15.52||||0.0603|TWO_SIDED|95.0|-32.4|1.3|||Chi-squared||Approximate 95% CI for the difference of two rates was determined using the Hauck-Anderson method.|||1.3|-32.4|0.0603
72492235|NCT00652366|144513007|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.83||||0.2678|TWO_SIDED|95.0|0.6|1.15|||Log Rank|||||1.15|0.60|0.2678
72492236|NCT00652366|144513007|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.03||||0.8449|TWO_SIDED|95.0|0.74|1.43|||Log Rank|||||1.43|0.74|0.8449
72492237|NCT00652366|144513009|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.69||||0.0217|TWO_SIDED|95.0|0.51|0.95|||Log Rank|||||0.95|0.51|0.0217
72492238|NCT00652366|144513009|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.79||||0.1596|TWO_SIDED|95.0|0.57|1.1|||Log Rank|||||1.10|0.57|0.1596
72492239|NCT01181011|144513043|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence|gMean Ratio|109.22|STANDARD_ERROR_OF_MEAN|1.06||0.0107||90.0|99.45|119.95||The p-value is for the ratio being outside the interval 0.8 to 1.25.|ANCOVA|||||119.95|99.45|0.0107
72492240|NCT01181011|144513044|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence|gMean Ratio|109.84|STANDARD_ERROR_OF_MEAN|1.06||0.0139|TWO_SIDED|90.0|99.96|120.71||The p-value is for the ratio being outside the interval 0.8 to 1.25.|ANCOVA|||||120.71|99.96|0.0139
72492241|NCT01181011|144513045|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence|gMean Ratio|97.57|STANDARD_ERROR_OF_MEAN|1.09||0.0126|TWO_SIDED|90.0|84.643|112.472||The p-value is for the ratio being outside the interval 0.8 to 1.25.|ANCOVA|||||112.472|84.643|0.0126
72492242|NCT01181011|144513046|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence|gMean Ratio|109.7|STANDARD_ERROR_OF_MEAN|1.04||0.0011|TWO_SIDED|90.0|102.87|117.07||The p-value is for the ratio being outside the interval 0.8 to 1.25.|ANCOVA|||||117.07|102.87|0.0011
72569445|NCT00444457|144669744|SUPERIORITY_OR_OTHER||Difference in log-transformed GM|-0.02|||||TWO_SIDED|95.0|-0.14|0.1|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Additional serotypes - serotype 19A||0.10|-0.14|
72492243|NCT01181011|144513047|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence|gMean Ratio|108.8|STANDARD_ERROR_OF_MEAN|1.04||0.0006|TWO_SIDED|95.0|102.1|116.0||The p-value is for the ratio being outside the interval 0.8 to 1.25.|ANCOVA|||||116.0|102.1|0.0006
72492244|NCT01181011|144513048|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence|gMean Ratio|106.7|STANDARD_ERROR_OF_MEAN|1.03||0|TWO_SIDED|90.0|100.9|112.9||The p-value is for the ratio being outside the interval 0.8 to 1.25.|ANCOVA|||||112.9|100.9|0.000
72517779|NCT02703987|144565047|SUPERIORITY||Mean Difference (Net)|0.32|STANDARD_ERROR_OF_MEAN|0.17||0.0801|TWO_SIDED|95.0|-0.04|0.67|||Mixed Models Analysis|||||0.67|-0.04|0.0801
72517780|NCT02703987|144565048|SUPERIORITY||Mean Difference (Net)|0.34|STANDARD_ERROR_OF_MEAN|0.18||0.0714|TWO_SIDED|95.0|-0.03|0.71|||Mixed Models Analysis|||||0.71|-0.03|0.0714
72517781|NCT02703987|144565049|SUPERIORITY||Mean Difference (Net)|9.56|STANDARD_ERROR_OF_MEAN|4.85||0.0609|TWO_SIDED|95.0|-0.48|19.6|||Mixed Models Analysis|||||19.6|-0.48|0.0609
72517782|NCT01376245|144565053|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.14|||<|0.001|TWO_SIDED|95.0|0.089|0.191|||Mixed Models Analysis|Restricted Maximum Likelihood (REML)-based repeated measures approach (MMRM)||||0.191|0.089|<0.001
72517783|NCT01376245|144565053|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.179|||<|0.001|TWO_SIDED|95.0|0.129|0.23|||Mixed Models Analysis|Restricted Maximum Likelihood (REML)-based repeated measures approach (MMRM)||||0.230|0.129|<0.001
72517784|NCT01376245|144565053|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.194|||<|0.001|TWO_SIDED|95.0|0.143|0.245|||Mixed Models Analysis|Restricted Maximum Likelihood (REML)-based repeated measures approach (MMRM)||||0.245|0.143|<0.001
72517785|NCT01357889|144565075|NON_INFERIORITY_OR_EQUIVALENCE|To establish BE, the 90% CI for the ratio of Process 3 (P3) to Process 2 (P2) geometric least squares means (LSMs) for AUC (0-inf) must have fallen within the BE limit of 0.8 and 1.25.|Ratio of Geometric LSMs (P3:P2)|0.937|||||TWO_SIDED|90.0|0.842|1.042|||ANOVA|||||1.042|0.842|
72517786|NCT01357889|144565076|NON_INFERIORITY_OR_EQUIVALENCE|To establish BE, the 90% CI for the ratio of Process 3:Process 2 geometric least squares means for Cmax must have fallen within the BE limit of 0.8 and 1.25.|Ratio of Geometric LSMs (P3:P2)|0.927|||||TWO_SIDED|90.0|0.813|1.056|||ANOVA|||||1.056|0.813|
72492245|NCT00137111|144513065|SUPERIORITY_OR_OTHER_LEGACY||Binomial proportion|79.27|||||TWO_SIDED|95.0|75.69|82.85|||Binomial proportion|||Of the 498 eligible patients, 492 were successfully evaluated with day 46 MRD measurement.||82.85|75.69|
72492246|NCT00137111|144513066|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0062||||||p-value from t-test after stratified for lineage and ploidy|t-test, 2 sided|||t-test stratified for lineage and ploidy||||.0062
72492247|NCT00137111|144513067|SUPERIORITY_OR_OTHER_LEGACY|||||||0.15||||||p-value from t-test after adjusted for lineage and ploidy|t-test, 2 sided|||t-test adjusting for lineage and ploidy||||.15
72517787|NCT03970824|144565089|EQUIVALENCE|PK equivalence was concluded if 90% confidence intervals (CIs) for percent ratios of geometric least squares means in AUC0-inf, AUC0-last, and Cmax were within the equivalence margin of 80-125%.|Ratio of geometric least squares means|105.79|||||TWO_SIDED|90.0|97.19|115.16||||||Statistical analysis of primary PK parameters was performed using an analysis of covariance model (ANCOVA) including covariates for gender, study center, and body weight.||115.16|97.19|
72492248|NCT00137111|144513068|SUPERIORITY_OR_OTHER_LEGACY|||||||9.5e-07|||||||Wilcoxon (Mann-Whitney)|||||||0.00000095
72492249|NCT00137111|144513069|SUPERIORITY_OR_OTHER_LEGACY|||||||7e-07|||||||Wilcoxon (Mann-Whitney)|||||||0.0000007
72492250|NCT01223703|144513092|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|The analysis was done following an intention-to-treat approach by means of the unpaired student t test or Wilcoxon rank sum test as appropriated.||"null hypothesis is no difference n3 PUFA administration and placebo. To demonstrate an effect size of 0.5 in LVEF, a sample of 65 patients in each group was calculated to have 80% power to detect such 0.5 effect size with alpha=0.05 (2-tailed) at the Student t test.~for unpaired data."||||< 0.05
72492251|NCT01223703|144513093|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|The analysis was done following an intention-to-treat approach by means of the unpaired student t test or Wilcoxon rank sum test as appropriated.||||||< 0.05
72492252|NCT00784654|144513096|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|95.0|||||Cochran-Mantel-Haenszel|||||||< 0.001
72492253|NCT00784654|144513097|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||t-test, 2 sided|||||||<0.001
72492254|NCT00784654|144513098|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-12.6|||<|0.001|TWO_SIDED|95.0|-15.4|-9.8|||ANCOVA|||||-9.8|-15.4|<0.001
72492255|NCT00784654|144513101|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel|||||||<0.001
72492256|NCT00784654|144513105|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||t-test, 1 sided|||||||<0.001
72492257|NCT00784654|144513106|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|6.5|||<|0.001|TWO_SIDED|95.0|3.5|9.5|||ANCOVA|||||9.5|3.5|<0.001
72492258|NCT00784654|144513107|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||t-test, 1 sided|||||||<0.001
72492259|NCT00784654|144513108|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.19|||<|0.001|TWO_SIDED|95.0|-0.26|-0.11|||ANCOVA|||||-0.11|-0.26|<0.001
72492260|NCT00784654|144513111|SUPERIORITY_OR_OTHER_LEGACY|||||||0.726||95.0|||||Cochran-Mantel-Haenszel|||||||0.726
72492261|NCT04249687|144513114|SUPERIORITY|||||||0.05|||||||Cochran-Mantel-Haenszel|||||||0.05
72492262|NCT04249687|144513115|SUPERIORITY|||||||0.05|||||||Cochran-Mantel-Haenszel|||||||0.05
72492263|NCT00262873|144513118|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||t-test, 2 sided|||||||<0.05
72492264|NCT00262873|144513119|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||t-test, 2 sided|||||||<0.05
72492265|NCT00262873|144513120|SUPERIORITY_OR_OTHER|||||||0.05|TWO_SIDED||||||t-test, 2 sided|||||||0.05
72492266|NCT00844753|144513124|SUPERIORITY_OR_OTHER|||||||0.47|TWO_SIDED||||||Chi-squared|||||||0.47
72492267|NCT00844753|144513125|SUPERIORITY_OR_OTHER|||||||0.95|TWO_SIDED||||||Chi-squared|||||||0.95
72492268|NCT02425826|144513126|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-39.84|||<|0.0001|TWO_SIDED|95.0|-54.39|-25.3|||ANCOVA|Based on 2-way ANCOVA with treatment and site as factors and baseline value as covariate.||||-25.30|-54.39|<0.0001
72492269|NCT02425826|144513127|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-2.5||||0.0008|TWO_SIDED|95.0|-3.9|-1.0|||ANCOVA|Based on 2-way ANCOVA with treatment and site as factors and baseline value as covariate.||||-1.0|-3.9|0.0008
72492270|NCT02425826|144513128|SUPERIORITY_OR_OTHER_LEGACY||Difference|21.0|||<|0.0001|TWO_SIDED|95.0|11.0|31.1||Two-sided p-value is based on the Cochran-Mantel-Haenszel test stratified by sites.|Cochran-Mantel-Haenszel||Two-sided 95% confidence intervals (CI) is based on normal approximation|||31.1|11.0|<0.0001
72492271|NCT02425826|144513129|SUPERIORITY_OR_OTHER_LEGACY||Difference|13.7||||0.0365|TWO_SIDED|95.0|1.7|25.7|||Cochran-Mantel-Haenszel|2-sided p-value is calculated based on Cochran-Mantel-Haenszel test stratified by sites.|Two-sided 95% CI is based on normal approximation|||25.7|1.7|0.0365
72517788|NCT03970824|144565089|EQUIVALENCE|PK equivalence was concluded if 90% confidence intervals (CIs) for percent ratios of geometric least squares means in AUC0-inf, AUC0-last, and Cmax were within the equivalence margin of 80-125%.|Ratio of geometric least squares means|92.63|||||TWO_SIDED|90.0|85.29|100.61||||||Statistical analysis of primary PK parameters was performed using an analysis of covariance model (ANCOVA) including covariates for gender, study center, and body weight.||100.61|85.29|
72517789|NCT03970824|144565089|EQUIVALENCE|PK equivalence was concluded if 90% confidence intervals (CIs) for percent ratios of geometric least squares means in AUC0-inf, AUC0-last, and Cmax were within the equivalence margin of 80-125%.|Ratio of geometric least squares means|98.0|||||TWO_SIDED|90.0|90.06|106.63||||||Statistical analysis of primary PK parameters was performed using an analysis of covariance model (ANCOVA) including covariates for gender, study center, and body weight.||106.63|90.06|
72517790|NCT03970824|144565090|EQUIVALENCE|PK equivalence was concluded if 90% confidence intervals (CIs) for percent ratios of geometric least squares means in AUC0-inf, AUC0-last, and Cmax were within the equivalence margin of 80-125%.|Ratio of geometric least squares means|107.3|||||TWO_SIDED|90.0|98.29|117.13||||||Statistical analysis of primary PK parameters was performed using an analysis of covariance model (ANCOVA) including covariates for gender, study center, and body weight.||117.13|98.29|
72517791|NCT03970824|144565090|EQUIVALENCE|PK equivalence was concluded if 90% confidence intervals (CIs) for percent ratios of geometric least squares means in AUC0-inf, AUC0-last, and Cmax were within the equivalence margin of 80-125%.|Ratio of geometric least squares means|93.93|||||TWO_SIDED|90.0|86.08|102.5||||||Statistical analysis of primary PK parameters was performed using an analysis of covariance model (ANCOVA) including covariates for gender, study center, and body weight.||102.50|86.08|
72517792|NCT03970824|144565090|EQUIVALENCE|PK equivalence was concluded if 90% confidence intervals (CIs) for percent ratios of geometric least squares means in AUC0-inf, AUC0-last, and Cmax were within the equivalence margin of 80-125%.|Ratio of geometric least squares means|100.79|||||TWO_SIDED|90.0|92.42|109.92||||||Statistical analysis of primary PK parameters was performed using an analysis of covariance model (ANCOVA) including covariates for gender, study center, and body weight.||109.92|92.42|
72517793|NCT03970824|144565091|EQUIVALENCE|PK equivalence was concluded if 90% confidence intervals (CIs) for percent ratios of geometric least squares means in AUC0-inf, AUC0-last, and Cmax were within the equivalence margin of 80-125%.|Ratio of geometric least squares means|101.89|||||TWO_SIDED|90.0|95.33|108.89||||||Statistical analysis of primary PK parameters was performed using an analysis of covariance model (ANCOVA) including covariates for gender, study center, and body weight.||108.89|95.33|
72569446|NCT00444457|144669744|SUPERIORITY_OR_OTHER||Difference in log-transformed GM|-0.03|||||TWO_SIDED|95.0|-0.15|0.08|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Additional serotypes - serotype 19A||0.08|-0.15|
72569447|NCT01121666|144669755|NON_INFERIORITY_OR_EQUIVALENCE|This study was powered to test equivalence using a two one-sided test (TOST) of the number of oocytes retrieved with a power of 90%, an alpha error of 2.5% and a pre-determined clinical equivalence margin of +/-2.9 oocytes for the relevant population.||||||0.0003|TWO_SIDED|||||This study was powered to test equivalence using a two one-sided test (TOST) with a power of 90%, an alpha error of 2.5% and a pre-determined clinical equivalence margin of +/-2.9 oocytes for the relevant population.|Shuirmann's TOST|||This study was powered to test equivalence using a two one-sided test (TOST) of the number of oocytes retrieved.||||0.0003
72517794|NCT03970824|144565091|EQUIVALENCE|PK equivalence was concluded if 90% confidence intervals (CIs) for percent ratios of geometric least squares means in AUC0-inf, AUC0-last, and Cmax were within the equivalence margin of 80-125%.|Ratio of geometric least squares means|98.2|||||TWO_SIDED|90.0|91.91|104.92||||||Statistical analysis of primary PK parameters was performed using an analysis of covariance model (ANCOVA) including covariates for gender, study center, and body weight.||104.92|91.91|
72517795|NCT03970824|144565091|EQUIVALENCE|PK equivalence was concluded if 90% confidence intervals (CIs) for percent ratios of geometric least squares means in AUC0-inf, AUC0-last, and Cmax were within the equivalence margin of 80-125%.|Ratio of geometric least squares means|100.05|||||TWO_SIDED|90.0|93.69|106.85||||||Statistical analysis of primary PK parameters was performed using an analysis of covariance model (ANCOVA) including covariates for gender, study center, and body weight.||106.85|93.69|
72517796|NCT00305604|144565112|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.7|STANDARD_DEVIATION|0.81|<|0.001||95.0|-0.94|-0.47|||ANCOVA|Model terms: treatment; baseline; prior anti-hyperglycemic therapy (yes/no); age (\< 75/\>= 75 yr); baseline creatinine clearance (\< 50/\>= 50 mL/min)||||-0.47|-0.94|<0.001
72517797|NCT00305604|144565113|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-26.8|STANDARD_DEVIATION|45.0|<|0.001||95.0|-40.0|-13.5|||ANCOVA|Model terms: treatment; baseline; prior anti-hyperglycemic therapy (yes/no); age (\< 75/\>= 75 yr); baseline creatinine clearance (\< 50/\>= 50 mL/min)||||-13.5|-40.0|<0.001
72517798|NCT00305604|144565114|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-61.0|STANDARD_DEVIATION|63.0|<|0.001||95.0|-82.1|-40.0|||ANCOVA|Model terms: treatment; baseline; prior anti-hyperglycemic therapy (yes/no); age (\< 75/\>= 75 yr); baseline creatinine clearance (\< 50/\>= 50 mL/min)||||-40.0|-82.1|<0.001
72517799|NCT00305604|144565115|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-23.5|STANDARD_DEVIATION|25.2|<|0.001||95.0|-32.6|-14.4|||ANCOVA|Model terms: treatment; baseline; prior anti-hyperglycemic therapy (yes/no); age (\< 75/\>= 75 yr); baseline creatinine clearance (\< 50/\>= 50 mL/min)||||-14.4|-32.6|<0.001
72517800|NCT01248364|144565124|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.19|STANDARD_ERROR_OF_MEAN|0.18||0.279|TWO_SIDED|95.0|-0.16|0.55|||ANCOVA|Based on ANCOVA with terms for baseline FPG, diagnosis group, and baseline FPG by diagnosis group interaction.|Difference calculated as T2DM metformin minus T2DM Naive|No formal testing, exploratory analysis only.||0.55|-0.16|0.2790
72517801|NCT01248364|144565125|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.23|STANDARD_ERROR_OF_MEAN|0.2||0.2438|TWO_SIDED|95.0|-0.16|0.62|||ANCOVA|Based on ANCOVA with terms for baseline FPG, diagnosis group and baseline FPG by diagnosis group interaction.|Difference calculated as T2DM metformin minus T2DM Naive|No formal testing, exploratory analysis only.||0.62|-0.16|0.2438
72569448|NCT01121666|144669756|SUPERIORITY_OR_OTHER|||||||0.2357|TWO_SIDED|||||Follicles of 12 mm|Wilcoxon (Mann-Whitney)|||||||0.2357
72569449|NCT01121666|144669756|SUPERIORITY_OR_OTHER|||||||0.1395|TWO_SIDED|||||Follicles of 15 mm|Wilcoxon (Mann-Whitney)|||||||0.1395
72569450|NCT01121666|144669756|SUPERIORITY_OR_OTHER|||||||0.3992|TWO_SIDED|||||Follicles of 17 mm|Wilcoxon (Mann-Whitney)|||||||0.3992
72492272|NCT02425826|144513130|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-11.6||||0.0016|TWO_SIDED|95.0|-18.8|-4.5|||ANCOVA|Based on 2-way ANCOVA with treatment and site as factors and baseline value as covariate.||The treatment comparison was only done for Week 16; End of Phase||-4.5|-18.8|0.0016
72492273|NCT02425826|144513131|SUPERIORITY_OR_OTHER_LEGACY||Difference|11.8||||0.0463|TWO_SIDED|95.0|-4.0|27.6|||Cochran-Mantel-Haenszel|p-value was based on 2-sided CMH tests stratified by sites.|Two-sided 95% CI is based on normal approximation.|||27.6|-4.0|0.0463
72492274|NCT02425826|144513132|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|17.8|||<|0.0001|TWO_SIDED|95.0|10.36|25.24|||ANOVA|Based on 2-way ANOVA with treatment and site as factors.||TSQM-Effectiveness||25.24|10.36|<0.0001
72517802|NCT01248364|144565126|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3|STANDARD_ERROR_OF_MEAN|0.75||0.6931|TWO_SIDED|95.0|-1.19|1.79|||ANCOVA|Based on ANCOVA with terms for baseline EPG fast, diagnosis group and baseline EPG fast by diagnosis group interaction.|Difference calculated as T2DM metformin minus T2DM Naive|No formal testing, exploratory analysis only.||1.79|-1.19|0.6931
72517803|NCT01248364|144565127|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.84|STANDARD_ERROR_OF_MEAN|1.12||0.1028|TWO_SIDED|95.0|-0.38|4.07|||ANCOVA|Based on ANCOVA with terms for baseline EPG fast, diagnosis group and baseline EPG fast by diagnosis group interaction.|Difference calculated as T2DM metformin minus T2DM Naive|No formal testing, exploratory analysis only.||4.07|-0.38|0.1028
72569451|NCT01121666|144669758|SUPERIORITY_OR_OTHER|||||||0.9638|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.9638
72569452|NCT01121666|144669763|SUPERIORITY_OR_OTHER|||||||0.8926|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.8926
72492275|NCT02425826|144513132|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|5.0||||0.3433|TWO_SIDED|95.0|-5.4|15.4|||ANOVA|Based on 2-way ANOVA with treatment and site as factors.||TSQM - Side Effects||15.40|-5.40|0.3433
72492276|NCT02425826|144513132|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|1.4||||0.625|TWO_SIDED|95.0|-4.25|7.06|||ANOVA|Based on 2-way ANOVA with treatment and site as factors.||TSMQ-Convenience||7.06|-4.25|0.6250
72517804|NCT01248364|144565128|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.48|STANDARD_ERROR_OF_MEAN|2.52||0.0326|TWO_SIDED|95.0|0.47|10.5|||ANCOVA|Based on ANCOVA with terms for baseline EPG AUC 5h, diagnosis group and baseline EPG AUC 5h by diagnosis group interaction.|Difference calculated as T2DM metformin minus T2DM Naive|No formal testing, exploratory analysis only.||10.50|0.47|0.0326
72517805|NCT01248364|144565129|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.58|STANDARD_ERROR_OF_MEAN|0.81||0.0552|TWO_SIDED|95.0|-3.2|0.04|||ANCOVA|Based on ANCOVA with terms for baseline PPG iAUC 5h, diagnosis group and baseline PPG iAUC 5h by diagnosis group interaction.|Difference calculated as T2DM metformin minus T2DM Naive|No formal testing, exploratory analysis only.||0.04|-3.20|0.0552
72492277|NCT02425826|144513132|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|14.07|||<|0.0001|TWO_SIDED|95.0|7.16|20.97|||ANOVA|||TSQM-Global Satisfaction||20.97|7.16|<0.0001
72492278|NCT02425826|144513134|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-37.0|||<|0.0001|TWO_SIDED|95.0|-54.08|-19.91|||ANCOVA|Based on 2-way ANCOVA with treatment and site as factors and baseline value as covariate||||-19.91|-54.08|<0.0001
72517806|NCT01248364|144565130|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.31|STANDARD_ERROR_OF_MEAN|0.99||0.7561|TWO_SIDED|95.0|-1.66|2.27|||ANCOVA|Based on ANCOVA with terms for baseline PPG iAUC 5h, diagnosis group and baseline PPG iAUC 5h by diagnosis group interaction.|Difference calculated as T2DM metformin minus T2DM Naive|No formal testing, exploratory analysis only.||2.27|-1.66|0.7561
72517807|NCT01248364|144565131|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.13|STANDARD_ERROR_OF_MEAN|1.89||0.1024|TWO_SIDED|95.0|-0.64|6.9|||ANCOVA|Based on ANCOVA with terms for baseline EPG AUC 5h, diagnosis group and baseline EPG AUC 5h by diagnosis group interaction.|Difference calculated as T2DM metformin minus T2DM Naive|No formal testing, exploratory analysis only.||6.90|-0.64|0.1024
72569453|NCT01121666|144669770|NON_INFERIORITY_OR_EQUIVALENCE|This study was powered to test equivalence using a two one-sided test (TOST) of the number of oocytes retrieved with a power of 90%, an alpha error of 2.5% and a pre-determined clinical equivalence margin of +/-2.9 oocytes for the relevant population.||||||0.0003|TWO_SIDED||||||Shuirmann's TOST|||||||0.0003
72569454|NCT03176459|144669779|SUPERIORITY||LSM treatment difference|-16.5||||0.0117|TWO_SIDED|95.0|-30.8|-2.2|||ANCOVA|||||-2.2|-30.8|0.0117
72569455|NCT03176459|144669780|NON_INFERIORITY|Pre-specified non-inferiority margin of 36|LSM treatment difference (SE)|-30.6||||0.002|TWO_SIDED|95.0|-75.9|14.7|||ANCOVA|||||14.7|-75.9|0.0020
72569456|NCT03176459|144669781|SUPERIORITY||Odds Ratio (OR)|3.51||||0.0012|TWO_SIDED|95.0|1.557|7.906|||LSM probability from logistic regression|||||7.906|1.557|0.0012
72569457|NCT03176459|144669782|SUPERIORITY||Least squares treatment difference|-3.2||||0.0543|TWO_SIDED||||||ANCOVA|||||||.0543
72569458|NCT03176459|144669783|SUPERIORITY||Least squares treatment difference|-11.4||||0.0096|ONE_SIDED||||||ANCOVA|||||||.0096
72569459|NCT03176459|144669784|SUPERIORITY||Least squares treatment difference|-22.4||||0.0175|TWO_SIDED||||||ANCOVA|||||||.0175
72492279|NCT02425826|144513135|SUPERIORITY_OR_OTHER_LEGACY||Difference|29.1|||<|0.0001|TWO_SIDED|95.0|16.3|41.8|||Cochran-Mantel-Haenszel|2-sided p-value is calculated based on Cochran-Mantel-Haenszel test stratified by sites.|Two-sided 95% CI is based on normal approximation|||41.8|16.3|<0.0001
72492280|NCT02425826|144513136|SUPERIORITY_OR_OTHER_LEGACY||Difference|13.5||||0.0136|TWO_SIDED|95.0|4.4|22.7|||Cochran-Mantel-Haenszel|2-sided Cochran-Mantel-Haenszel test stratified by sites.|2-sided 95% CI is based on normal approximation.|||22.7|4.4|0.0136
72492281|NCT04036968|144513141|SUPERIORITY|Comparison of three drug conditions with cannabidiol to control groups placebo+placebo and hydromorphone+placebo||||||0.195|||||||ANOVA|||||||0.195
72492282|NCT04036968|144513142|SUPERIORITY||||||<|0.001|||||||ANOVA|||||||<.001
72492283|NCT04036968|144513143|SUPERIORITY|||||||0.074|||||||ANOVA|||||||0.074
72569460|NCT03176459|144669785|SUPERIORITY||Least squares treatment difference|-19.6||||0.0542|TWO_SIDED||||||ANCOVA|||||||.0542
72569461|NCT03176459|144669786|SUPERIORITY|||||||0.7536|||||||Regression, Cox|||||||0.7536
72569462|NCT03176459|144669787|SUPERIORITY||Odds Ratio (OR)|1.14||||0.3609|TWO_SIDED||||||Regression, Logistic|||||||0.3609
72569463|NCT01383421|144669881|SUPERIORITY||||||<|0.001||||||Statistical significance was set at P = 0.05.|Chi-squared|||||||< 0.001
72569464|NCT01383421|144669883|SUPERIORITY|||||||0.058||||||Statistical significance was set at P = 0.05.|Chi-squared|||||||0.058
72569465|NCT01383421|144669885|SUPERIORITY|||||||0.003||||||Statistical significance was set at P = 0.05.|Chi-squared|||||||0.003
72569466|NCT01383421|144669887|SUPERIORITY||LS Mean Difference|-0.203|STANDARD_ERROR_OF_MEAN|0.092||0.027|TWO_SIDED|||||Statistical significance was set at P = 0.05.|ANCOVA|LS mean difference and P value are from ANCOVA model adjusting for corresponding Baseline values.||Week 24||||0.027
72405166|NCT00847288|144318024|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.5||||0.0043|TWO_SIDED|95.0|1.1|2.0||Cox proportional hazard model was fitted with the group effect and other key baseline variables. The p-value for the main group effect is 0.0043, with an estimated hazard ratio of 1.5, monthly vs quarterly.|Regression, Cox|||"Let TM and TQ denote the median survival time to initiation of clinical action in monthly and quarterly review groups respectively. Null Hypothesis (HO): The time to initiation of clinical action is not affected by review frequency (monthly versus quarterly): TM=TQ Alternative Hypothesis (HA): The time to initiation of clinical action is affected by review frequency (monthly versus quarterly): TM≠TQ~Cox proportional hazard model will be fitted to estimate the hazard ratio."||2.0|1.1|0.0043
72405167|NCT00847288|144318026|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.44||||0.0001|TWO_SIDED|95.0|1.2|1.74|||logistic GEE for repeated observations|||The probability of action taken in three months interval is evaluated using the generalized estimating equations (GEE) method under a logistic regression model. Univariate analysis is performed first for potential predictors and only those with a p-value less than 0.10 through univariate analysis are included in the multivariate model. Here we report the odds ratio of monthly arm against quarterly arm, adjusting for OptiVol crossing, new or chronic device, and AF or no AF.||1.74|1.20|0.0001
72405168|NCT04448210|144318028|SUPERIORITY||||||<|0.25|||||||ANOVA|||||||<.25
72492284|NCT02997904|144513144|SUPERIORITY||Least Squares Mean Difference|1.0058|STANDARD_ERROR_OF_MEAN|0.2131|<|0.0001|TWO_SIDED|95.0|0.5829|1.4288|||ANOVA|||Ho: Total Number of lice and eggs removed with Resultz® ≤ Total number of lice and eggs removed with sham control Ha: Total Number of lice and eggs removed with Resultz® \> Total Number of lice and eggs removed with sham control||1.4288|0.5829|<0.0001
72492285|NCT02997904|144513145|SUPERIORITY||Least Squares Mean Difference|1.2084|STANDARD_ERROR_OF_MEAN|0.0467|<|0.0001|TWO_SIDED|95.0|1.1157|1.3011||The P-Values were \<0.0001 in both comparison groups; total number lice removed and total number of eggs removed|GLIMMX|||Comparison of total number of lice removed and total number of eggs removed were analyzed separately||1.3011|1.1157|<0.0001
72492286|NCT02997904|144513145|SUPERIORITY||Least Squares Mean Difference|0.7899|STANDARD_ERROR_OF_MEAN|0.04565|<|0.0001|TWO_SIDED|95.0|0.6993|0.8805|||GLIMMX|||||0.8805|0.6993|<0.0001
72492287|NCT00852995|144513158|SUPERIORITY_OR_OTHER|||||||0.00028|TWO_SIDED||||||t-test, 2 sided|||||||0.00028
72492288|NCT00852995|144513158|SUPERIORITY_OR_OTHER|||||||0.0899|TWO_SIDED||||||t-test, 2 sided|||||||0.0899
72492289|NCT00852995|144513158|SUPERIORITY_OR_OTHER|||||||0.1586|TWO_SIDED||||||t-test, 2 sided|||||||0.1586
72492290|NCT00852995|144513158|SUPERIORITY_OR_OTHER|||||||0.0295|TWO_SIDED||||||t-test, 2 sided|||||||0.0295
72492291|NCT00852995|144513160|SUPERIORITY_OR_OTHER|||||||0.037|TWO_SIDED|||||Treatment Week 01|ANCOVA|||||||.037
72492292|NCT00852995|144513160|SUPERIORITY_OR_OTHER|||||||0.064|TWO_SIDED|||||Treatment Week 02|ANCOVA|||||||.064
72492293|NCT00852995|144513160|SUPERIORITY_OR_OTHER|||||||0.161|TWO_SIDED|||||Treatment Week 03|ANCOVA|||||||.161
72492294|NCT00852995|144513160|SUPERIORITY_OR_OTHER|||||||0.39|TWO_SIDED|||||Treatment Week 04|ANCOVA|||||||.39
72492295|NCT00852995|144513160|SUPERIORITY_OR_OTHER|||||||0.079|TWO_SIDED|||||Treatment Week 05|ANCOVA|||||||.079
72492296|NCT00852995|144513160|SUPERIORITY_OR_OTHER|||||||0.069|TWO_SIDED|||||Treatment Week 06|ANCOVA|||||||.069
72492297|NCT00852995|144513160|SUPERIORITY_OR_OTHER|||||||0.026|TWO_SIDED|||||Treatment Week 07|ANCOVA|||||||.026
72492298|NCT00852995|144513160|SUPERIORITY_OR_OTHER|||||||0.133|TWO_SIDED|||||Treatment Week 08|ANCOVA|||||||.133
72492299|NCT00852995|144513160|SUPERIORITY_OR_OTHER|||||||0.089|TWO_SIDED|||||Treatment Week 09|ANCOVA|||||||.089
72492300|NCT00852995|144513160|SUPERIORITY_OR_OTHER|||||||0.057|TWO_SIDED|||||Treatment Week 10|ANCOVA|||||||.057
72492301|NCT00852995|144513160|SUPERIORITY_OR_OTHER|||||||0.127|TWO_SIDED|||||Treatment Week 11|ANCOVA|||||||.127
72492302|NCT00852995|144513160|SUPERIORITY_OR_OTHER|||||||0.395|TWO_SIDED|||||Treatment Week 12|ANCOVA|||||||0.395
72492303|NCT00852995|144513161|SUPERIORITY_OR_OTHER|||||||0.0133|TWO_SIDED|||||Visit 02|Cochran-Mantel-Haenszel|||||||0.0133
72492304|NCT00852995|144513161|SUPERIORITY_OR_OTHER|||||||0.3839|TWO_SIDED|||||Visit 02|Cochran-Mantel-Haenszel|||||||0.3839
72492305|NCT00852995|144513161|SUPERIORITY_OR_OTHER|||||||0.5721|TWO_SIDED|||||Visit 02|Cochran-Mantel-Haenszel|||||||0.5721
72492306|NCT00852995|144513161|SUPERIORITY_OR_OTHER|||||||0.232|TWO_SIDED|||||Visit 02|Cochran-Mantel-Haenszel|||||||0.232
72492307|NCT00852995|144513161|SUPERIORITY_OR_OTHER|||||||0.0787|TWO_SIDED|||||Visit 03|Cochran-Mantel-Haenszel|||||||0.0787
72569467|NCT01383421|144669887|SUPERIORITY||LS Mean Difference|-0.26|STANDARD_ERROR_OF_MEAN|0.094||0.006|TWO_SIDED|||||Statistical significance was set at P = 0.05.|ANCOVA|LS mean difference and P value are from ANCOVA model adjusting for corresponding Baseline values.||Week 52||||0.006
72405169|NCT04448210|144318029|SUPERIORITY|||||||0.72|||||||ANOVA|||||||.72
72492308|NCT00852995|144513161|SUPERIORITY_OR_OTHER|||||||0.7919|TWO_SIDED|||||Visit 03|Cochran-Mantel-Haenszel|||||||0.7919
72492309|NCT00852995|144513161|SUPERIORITY_OR_OTHER|||||||0.6881|TWO_SIDED|||||Visit 03|Cochran-Mantel-Haenszel|||||||0.6881
72492310|NCT00852995|144513161|SUPERIORITY_OR_OTHER|||||||0.9832|TWO_SIDED|||||Visit 03|Cochran-Mantel-Haenszel|||||||0.9832
72492311|NCT00852995|144513161|SUPERIORITY_OR_OTHER|||||||0.0466|TWO_SIDED|||||Visit 04|Cochran-Mantel-Haenszel|||||||0.0466
72492312|NCT00852995|144513161|SUPERIORITY_OR_OTHER|||||||0.8435|TWO_SIDED|||||Visit 04|Cochran-Mantel-Haenszel|||||||0.8435
72405170|NCT04448210|144318030|SUPERIORITY|||||||0.16|||||||ANOVA|||||||.16
72405171|NCT04448210|144318031|SUPERIORITY|||||||0.43|||||||ANOVA|||||||.43
72492313|NCT00852995|144513161|SUPERIORITY_OR_OTHER|||||||0.8743|TWO_SIDED|||||Visit 04|Cochran-Mantel-Haenszel|||||||0.8743
72492314|NCT00852995|144513161|SUPERIORITY_OR_OTHER|||||||0.2884|TWO_SIDED|||||Visit 04|Cochran-Mantel-Haenszel|||||||0.2884
72492315|NCT00852995|144513161|SUPERIORITY_OR_OTHER|||||||0.0387|TWO_SIDED|||||Visit 05|Cochran-Mantel-Haenszel|||||||0.0387
72492316|NCT00852995|144513161|SUPERIORITY_OR_OTHER|||||||0.8461|TWO_SIDED|||||Visit 05|Cochran-Mantel-Haenszel|||||||0.8461
72492317|NCT00852995|144513161|SUPERIORITY_OR_OTHER|||||||0.9574|TWO_SIDED|||||Visit 05|Cochran-Mantel-Haenszel|||||||0.9574
72405172|NCT04448210|144318032|SUPERIORITY|||||||0.69|||||||ANOVA|||||||.69
72405173|NCT04448210|144318033|SUPERIORITY|||||||0.38|||||||ANOVA|||||||.38
72405174|NCT04448210|144318034|SUPERIORITY|||||||0.94|||||||ANOVA|||||||.94
72405175|NCT04448210|144318035|SUPERIORITY|||||||0.94|||||||ANOVA|||||||.94
72405176|NCT04448210|144318036|SUPERIORITY|||||||0.3|||||||ANOVA|||||||.30
72405177|NCT05627518|144318218|OTHER||Ratio|1.9954|||<|0.0001|TWO_SIDED|95.0|1.8399|2.1641|||Mixed Models Analysis||Treatment B (1x100 mg test formulation) divided by treatment A (4x25 mg reference formulation)|The Ratio of geometric mean AUCinf comparing test formulation fasted (treatment B) vs. reference formulation fasted ( treatment A). This is a relative comparison, thus there is no unit. The ratio is given under the Estimated value.||2.1641|1.8399|<0.0001
72405178|NCT05627518|144318218|OTHER||Ratio|2.125|||<|0.0001|TWO_SIDED|95.0|1.9664|2.2963|||Mixed Models Analysis||Treatment B (1x100 mg test formulation) divided by treatment A (4x25 mg reference formulation)|AUClast: Ratio of geometric mean AUClast comparing test formulation fasted (treatment B) vs. reference formulation fasted (treatment A). This is a relative comparison, thus there is no unit. The ratio is given under the Estimated value.||2.2963|1.9664|<0.0001
72405179|NCT05627518|144318219|OTHER|Ratio|Ratio|2.3167|||<|0.0001|TWO_SIDED|95.0|2.0922|2.5652|||Mixed Models Analysis||Treatment B (1x100 mg test formulation) divided by treatment A (4x25 mg reference formulation)|Ratio of geometric mean Cmax comparing test formulation fasted (treatment B) vs. reference formulation fasted (treatment A). This is a relative comparison, thus there is no unit. The ratio is given under the Estimated value.||2.5652|2.0922|<0.0001
72405180|NCT05627518|144318220|OTHER|Ratio|Ratio|0.757|||<|0.0001|TWO_SIDED|95.0|0.7009|0.8177|||Mixed Models Analysis||Treatment C (1x100 mg test formulation fed) divided by treament B (100 mg test formulation fasted)|Ratio of geometric mean AUCinf comparing treatment C (fed) versus treatment B (fasted). This is a relative comparison, thus there is no unit. The ratio is given under the Estimated value.||0.8177|0.7009|<0.0001
72405181|NCT05627518|144318220|OTHER|Ratio|Ratio|0.7684|||<|0.0001|TWO_SIDED|95.0|0.7102|0.8313|||Mixed Models Analysis||Treatment C (1x100 mg test formulation fed) divided by treament B (100 mg test formulation fasted)|Ratio of geometric mean AUClast comparing treatment C (fed) versus treatment B (fasted). This is a relative comparison, thus there is no unit. The ratio is given under the Estimated value.||0.8313|0.7102|<0.0001
72405182|NCT05627518|144318221|OTHER|Ratio|Ratio|0.2548|||<|0.0001|TWO_SIDED|95.0|0.1999|0.3247|||Mixed Models Analysis||Treatment C (1x100 mg test formulation fed) divided by treament B (100 mg test formulation fasted)|Ratio of geometric mean Cmax comparing treatment C (fed) versus treatment B (fasted). This is a relative comparison, thus there is no unit. The ratio is given under the Estimated value.||0.3247|0.1999|<0.0001
72405183|NCT05627518|144318222|OTHER|Ratio|Ratio|3.0245|||<|0.0001|TWO_SIDED|95.0|2.5098|3.6446|||Mixed Models Analysis||Treatment B (1x100 mg test formulation) divided by treament A (4x25 mg reference formulation)|Ratio of geometric mean AUCinf comparing test formulation fasted (treatment B) vs. reference formulation fasted ( treatment A). This is a relative comparison, thus there is no unit. The ratio is given under the Estimated value.||3.6446|2.5098|<0.0001
72492318|NCT00852995|144513161|SUPERIORITY_OR_OTHER|||||||0.2994|TWO_SIDED|||||Visit 05|Cochran-Mantel-Haenszel|||||||0.2994
72492319|NCT00852995|144513161|SUPERIORITY_OR_OTHER|||||||0.1024|TWO_SIDED|||||Visit 06|Cochran-Mantel-Haenszel|||||||0.1024
72405184|NCT05627518|144318222|OTHER|Ratio|Ratio|3.5277|||<|0.0001|TWO_SIDED|95.0|2.9076|4.2799|||Mixed Models Analysis||Treatment B (1x100 mg test formulation) divided by treament A (4x25 mg reference formulation)|Ratio of geometric mean AUClast comparing test formulation fasted (treatment B) vs. reference formulation fasted (treatment A). This is a relative comparison, thus there is no unit. The ratio is given under the Estimated value.||4.2799|2.9076|<0.0001
72405185|NCT05627518|144318223|OTHER|Ratio|Ratio|3.0245|||<|0.0001|TWO_SIDED|95.0|2.5098|3.6446|||Mixed Models Analysis||Treatment B (1x100 mg test formulation) divided by treament A (4x25 mg reference formulation)|Ratio of geometric mean Cmax comparing test formulation fasted (treatment B) vs. reference formulation fasted ( treatment A). This is a relative comparison, thus there is no unit. The ratio is given under the Estimated value.||3.6446|2.5098|<0.0001
72405186|NCT05627518|144318224|OTHER|Ratio|Ratio|0.4923|||<|0.0001|TWO_SIDED|95.0|0.4131|0.5867|||Mixed Models Analysis||Treatment C (1x100 mg test formulation fed) divided by treament B (100 mg test formulation fasted)|Ratio of geometric mean AUCinf comparing treatment C (fed) versus treatment B (fasted). This is a relative comparison, thus there is no unit. The ratio is given under the Estimated value.||0.5867|0.4131|<0.0001
72405187|NCT05627518|144318224|OTHER|Ratio|Ratio|0.4923|||<|0.0001|TWO_SIDED|95.0|0.4047|0.5989|||Mixed Models Analysis||Treatment C (1x100 mg test formulation fed) divided by treament B (100 mg test formulation fasted)|Ratio of geometric mean AUClast comparing treatment C (fed) versus treatment B (fasted). This is a relative comparison, thus there is no unit. The ratio is given under the Estimated value.||0.5989|0.4047|<0.0001
72405188|NCT05627518|144318225|OTHER|Ratio|Ratio|0.2522|||<|0.0001|TWO_SIDED|95.0|0.198|0.3211|||Mixed Models Analysis||Treatment C (1x100 mg test formulation fed) divided by treament B (100 mg test formulation fasted)|Ratio of geometric mean Cmax comparing test formulation fed (treatment C) vs. reference formulation fasted (treatment B). This is a relative comparison, thus there is no unit. The ratio is given under the Estimated value.||0.3211|0.1980|<0.0001
72405189|NCT03003520|144318235|SUPERIORITY||||||>|0.99||||||Significance defined as 0.05.|Fisher Exact|||||||>0.99
72405190|NCT03003520|144318235|SUPERIORITY||AUC-ROC|0.477||||0.872|TWO_SIDED|||||Significance defined as 0.05.|Wilcoxon (Mann-Whitney)|||The Area Under the Receiver Operator Characteristic Curve (AUC-ROC) is the estimated parameter. Responders were compared to non-responders by ranking them according to their CD8 density.||||0.872
72405191|NCT03003520|144318236|SUPERIORITY|||||||0.0403||||||Significance defined as 0.05.|Fisher Exact|||||||0.0403
72405192|NCT03003520|144318236|SUPERIORITY||AUC-ROC|0.583||||0.523|TWO_SIDED|||||Significance defined as 0.05.|Wilcoxon (Mann-Whitney)|||The Area Under the Receiver Operator Characteristic Curve (AUC-ROC) is the estimated parameter. Responders were compared to non-responders by ranking them according to their PDL1 % of total cells.||||0.523
72405193|NCT03003520|144318237|SUPERIORITY||||||>|0.99||||||Significance defined as 0.05.|Fisher Exact|||||||>0.99
72405194|NCT03003520|144318237|SUPERIORITY||AUC-ROC|0.583||||0.557|TWO_SIDED|||||Significance defined as 0.05.|Wilcoxon (Mann-Whitney)|||The Area Under the Receiver Operator Characteristic Curve (AUC-ROC) is the estimated parameter. Responders were compared to non-responders by ranking them according to their PDL1 % of tumor cells.||||0.557
72517808|NCT01248364|144565132|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.31|STANDARD_ERROR_OF_MEAN|2.93||0.6576|TWO_SIDED|95.0|-4.53|7.14|||ANCOVA|Based on ANCOVA with terms for baseline EPG iAUC 5h, diagnosis group and baseline EPG iAUC 5h by diagnosis group interaction.|Difference calculated as T2DM metformin minus T2DM Naive|No formal testing, exploratory analysis only.||7.14|-4.53|0.6576
72517809|NCT01248364|144565133|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.68|STANDARD_ERROR_OF_MEAN|3.38||0.2795|TWO_SIDED|95.0|-10.41|3.05|||ANCOVA|Based on ANCOVA with terms for baseline EPG iAUC 5h, diagnosis group and baseline EPG iAUC 5h by diagnosis group interaction.|Difference calculated as T2DM metformin minus T2DM Naive|No formal testing, exploratory analysis only.||3.05|-10.41|0.2795
72517810|NCT00039741|144565185|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.15|STANDARD_ERROR_OF_MEAN|0.13||0.26|TWO_SIDED|95.0|-0.41|0.11|||Interval regression|Adjusted for baseline HIV-1 RNA, age (\<3 years vs 3 years), origin (PACTG vs PENTA sites), and perinatal ART exposure versus no exposure.||||0.11|-0.41|0.26
72517811|NCT00039741|144565185|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.06|STANDARD_ERROR_OF_MEAN|0.13||0.56|TWO_SIDED|95.0|-0.2|0.32|||Interval regression|Adjusted for baseline HIV-1 RNA, age (\<3 years vs 3 years), origin (PACTG vs PENTA sites), and perinatal ART exposure versus no exposure.||||0.32|-0.20|0.56
72517812|NCT00676793|144565298|SUPERIORITY_OR_OTHER||||||=|0.078||95.0|||||Wilcoxon (Mann-Whitney)|||The null hypothesis is that there is no change, i.e. median change=0.0.||||=0.078
72517813|NCT00676793|144565299|SUPERIORITY_OR_OTHER||||||=|0.094||95.0|||||Wilcoxon (Mann-Whitney)|||The null hypothesis is that there is no change, i.e. median change=0.0.||||=0.094
72517814|NCT01181778|144565312|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentage: Daily Pill|-0.4||||0.705|TWO_SIDED|95.0|-2.6|1.8|||Chi-squared|||Analysis of the difference in the percentage of participants who chose the Daily Pill before physician counseling and after physician counseling.||1.8|-2.6|0.705
72517815|NCT01181778|144565312|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentage: Weekly Patch|3.8|||<|0.0001|TWO_SIDED|95.0|2.6|5.0|||Chi-squared|||Analysis of the difference in the percentage of participants who chose the Weekly Patch before physician counseling and after physician counseling.||5.0|2.6|<0.0001
72517816|NCT01181778|144565312|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentage: Monthy Ring|16.0|||<|0.0001|TWO_SIDED|95.0|14.3|17.8|||Chi-squared|||Analysis of the difference in the percentage of participants who chose the Monthly Ring before physician counseling and after physician counseling.||17.8|14.3|<0.0001
72517817|NCT01181778|144565312|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentage: Other Method|-3.6|||<|0.0001|TWO_SIDED|95.0|-5.0|-2.2|||Chi-squared|||Analysis of the difference in the percentage of participants who chose Other Method before physician counseling and after physician counseling.||-2.2|-5.0|<0.0001
72517818|NCT01181778|144565312|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentage: Undecided|-15.8|||<|0.0001|TWO_SIDED|95.0|-17.6|-14.1|||Chi-squared|||Analysis of the difference in the percentage of participants who chose Undecided before physician counseling and after physician counseling.||-14.1|-17.6|<0.0001
72517819|NCT02455388|144565360|EQUIVALENCE|No equivalence margin set.|||||<|0.001|||||||Intraclass correlation coefficient|||||||<0.001
72517820|NCT02455388|144565361|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<0.05
72517821|NCT02455388|144565362|OTHER||Odds Ratio (OR)|1.7|||<|0.01|TWO_SIDED||||||Regression, Logistic|||||||<0.01
72517822|NCT01316939|144565363|SUPERIORITY_OR_OTHER||Percent difference of participants|-4.0|||||TWO_SIDED|95.0|-12.9|4.8||||||Placebo Vs GSK1605786A 500 mg once daily at Week 28 and 52||4.8|-12.9|
72517823|NCT01316939|144565363|SUPERIORITY_OR_OTHER||Percent difference of participants|-6.6|||||TWO_SIDED|95.0|-14.8|1.6||||||Placebo Vs GSK1605786A 500 mg BID at Week 28 and 52||1.6|-14.8|
72517824|NCT01316939|144565364|SUPERIORITY_OR_OTHER||Percent difference of participants|-4.0|||||TWO_SIDED|95.0|-12.2|4.2||||||Placebo Vs GSK1605786A 500 mg once daily at Week 28 and 52||4.2|-12.2|
72517825|NCT01316939|144565364|SUPERIORITY_OR_OTHER||Percent difference of participants|-5.3|||||TWO_SIDED|95.0|-13.1|2.6||||||||2.6|-13.1|
72517826|NCT01016678|144565394|SUPERIORITY_OR_OTHER||Difference in percentages|18.0||||0.0038|TWO_SIDED||||||Chi-squared|||Comparison of percentage of participants pain free at 2 hours post-dose (active) to percentage of participants pain free at 2 hours post-dose (placebo)||||0.0038
72517827|NCT01016678|144565395|SUPERIORITY_OR_OTHER||difference in percentages|8.0||||0.1294|TWO_SIDED||||||Chi-squared|||||||0.1294
72517828|NCT01779648|144565440|SUPERIORITY_OR_OTHER|||||||0.785||95.0|||||Chi-squared|||||||0.785
72517829|NCT01779648|144565441|SUPERIORITY_OR_OTHER|||||||0.195||95.0|||||t-test, 2 sided|||Mean of right and left leg values were compared between the two device groups.||||0.195
72517830|NCT01779648|144565442|SUPERIORITY_OR_OTHER|||||||0.722||95.0|||||t-test, 2 sided|||Mean of right and left leg values were compared between the two device groups.||||0.722
72517831|NCT01779648|144565443|SUPERIORITY_OR_OTHER|||||||0.158||95.0|||||t-test, 2 sided|||Mean of right and left leg values were compared between the two device groups.||||0.158
72517832|NCT01779648|144565444|SUPERIORITY_OR_OTHER|||||||0.301||95.0|||||t-test, 2 sided|||Mean of right and left leg values were compared between the two device groups.||||0.301
72517833|NCT01779648|144565445|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Mixed Models Analysis|Age, sex, body mass index, and baseline TVF (total volume flow) are controlled as fixed-effects parameters.||||||<0.001
72517834|NCT01779648|144565446|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Mixed Models Analysis|Age, sex, body mass index, and baseline PVF (peak volume flow) are controlled as fixed-effects parameters.||||||<0.001
72517835|NCT01779648|144565447|SUPERIORITY_OR_OTHER|||||||0.929||95.0|||||Mixed Models Analysis|Age, sex, body mass index, and baseline PV (peak velocity)are controlled as fixed-effects parameters.||||||0.929
72569468|NCT01383421|144669887|SUPERIORITY||LS Mean Difference|-0.233|STANDARD_ERROR_OF_MEAN|0.098||0.018|TWO_SIDED|||||Statistical significance was set at P = 0.05.|ANCOVA|LS mean difference and P value are from ANCOVA model adjusting for corresponding Baseline values.||Week 78||||0.018
72517836|NCT01779648|144565449|SUPERIORITY_OR_OTHER|||||||0.008||95.0|||||Mixed Models Analysis|Age, sex, body mass index, and baseline peak volume flow are controlled as fixed-effects parameters.||||||0.008
72517837|NCT01779648|144565450|SUPERIORITY_OR_OTHER|||||||0.132||95.0|||||Mixed Models Analysis|Age, sex, body mass index, and baseline total volume flow are controlled as fixed-effects parameters.||||||0.132
72517838|NCT03657810|144565474|SUPERIORITY||||||<|0.001|TWO_SIDED|95.0||||Type III P-Value are from the likelihood ration test from the logistic regression model with factors of treatment, gender, and investigator.|Regression, Logistic|||||||<0.001
72517839|NCT03657810|144565475|SUPERIORITY|||||||0.052|TWO_SIDED|95.0||||Type III P-Value are from the likelihood ration test from the logistic regression model with factors of treatment, gender, and investigator|Regression, Logistic|||||||0.052
72517840|NCT03004976|144565511|OTHER||Wilcoxon Mann-Whitney Odds|0.9|STANDARD_ERROR_OF_MEAN|0.248||0.71|TWO_SIDED|95.0|0.53|1.55||Wilcoxon Two Sample Test|Wilcoxon (Mann-Whitney)|||Primary efficacy analysis (mRS shift from baseline to 90 days)||1.55|0.53|0.71
72517841|NCT03004976|144565511|OTHER||Odds Ratio (OR)|0.9|STANDARD_ERROR_OF_MEAN|0.223||0.87|TWO_SIDED|95.0|0.4|2.3|||Cumulative Logit Proportional Odds Model|||Additional analysis of the primary endpoint (mRS score at 90 days), adjusted for baseline mRS, baseline NIHSS, and institution.||2.3|0.4|0.87
72517842|NCT05034614|144565543|SUPERIORITY|||||||0.75|||||||Chi-squared|||||||.75
72517843|NCT03892707|144565547|SUPERIORITY|The between-group comparison on primary endpoint - change from baseline in pain intensity as measured on 0-10 points NRS scale at 10 days after the start of treatment was performed using analysis of covariance (ANCOVA). The difference between pain intensity at 10 days after the start of treatment and baseline (V3-V1) as response variable, treatment group as fixed factor and baseline pain intensity as a covariate was included into the model.|||||<|0.001|||||||ANCOVA|||"Since the superiority of one treatment over the other is investigated and taking into consideration that smaller negative values of the primary variable correspond to the greater reduction of pain, the statistical hypotheses are:~Null hypothesis (H0):~H0: μ2 - μ1 ≥ 0~Alternative hypothesis (HA):~HA: μ2 - μ1 \< 0, where μ1 и μ2 are the mean changes from baseline in pain intensity for (1) modern NSAIDs therapy and for (2) modern NSAIDs + Milgamma\\ Milgamma compositum therapy, correspondingly."||||<0.001
72517844|NCT03892707|144565548|SUPERIORITY||||||<|0.001|||||||ANCOVA|||Changes from baseline in pain intensity measured on 0-10 points NRS scale at 5, 24 and 38 days after were compared between groups using ANCOVA models similar to those used for the analysis of the primary variable.||||<0.001
72517845|NCT03892707|144565549|SUPERIORITY||||||<|0.001|||||||ANCOVA|||||||<0.001
72517846|NCT03892707|144565550|SUPERIORITY|Between-group comparison was carried out using logistic regression with treatment group as fixed factor and baseline pain intensity as a covariate. Treatment effect was tested using the corresponding p-value.|||||<|0.001|||||||Regression, Logistic|||For Visit 2 (5 days after the start of treatment) relief in pain intensity was defined as 100%\*(pain intensity at baseline - pain intensity at Visit 2)/ pain intensity at baseline. The denominator for the proportion of patients was the number of patients with available pain intensity measurements after imputation using Last observation carried forward (LOCF) method.||||<0.001
72517847|NCT03892707|144565550|SUPERIORITY|Between-group comparison was carried out using logistic regression with treatment group as fixed factor and baseline pain intensity as a covariate. Treatment effect was tested using the corresponding p-value.|||||<|0.001|||||||Regression, Logistic|||For Visit 3 (10 days after the start of treatment) relief in pain intensity was defined as 100%\*(pain intensity at baseline - pain intensity at Visit 3)/ pain intensity at baseline. The denominator for the proportion of patients was the number of patients with available pain intensity measurements after imputation using Last observation carried forward (LOCF) method.||||<0.001
72517848|NCT03892707|144565550|SUPERIORITY|Between-group comparison was carried out using logistic regression with treatment group as fixed factor and baseline pain intensity as a covariate. Treatment effect was tested using the corresponding p-value.||||||0.061|||||||Regression, Logistic|||For Visit 4 (24 days after the start of treatment) relief in pain intensity was defined as 100%\*(pain intensity at baseline - pain intensity at Visit 4)/ pain intensity at baseline. The denominator for the proportion of patients was the number of patients with available pain intensity measurements after imputation using Last observation carried forward (LOCF) method.||||0.061
72517849|NCT03892707|144565551|SUPERIORITY||||||<|0.001|||||||ANCOVA|||Change from baseline in pain-related disability as measured by Roland Morris disability questionnaire at 10 days after the start of treatment was compared between groups using analysis of covariance (ANCOVA) model with treatment group as fixed factor and baseline value disability score as a covariate.||||<0.001
72517850|NCT03892707|144565552|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||Episode of pain flare-up was defined as presence of at least 1 day with pain following a period without pain lasting at least 4 weeks . The denominator for the proportion was the number of FAS patients who had at least one pain-free period with approximately 4 weeks duration registered during the study.||||<0.001
72517851|NCT03892707|144565553|SUPERIORITY||Difference in proportion|28.6|||||TWO_SIDED|95.0|-3.6|60.7||||||Difference in proportion of patients with at least one pain flare-up resulting in consultancy with physician||60.7|-3.6|
72517852|NCT03892707|144565553|SUPERIORITY||Difference in proportion|-17.1|||||TWO_SIDED|95.0|-51.6|17.4||||||Difference in proportion of patients with at least one pain flare-up resulting in disruption of daily activity||17.4|-51.6|
72517853|NCT03892707|144565553|SUPERIORITY||Difference in proportion|25.7|||||TWO_SIDED|95.0|-4.1|55.5||||||Difference in proportion of patients with at least one pain flare-up resulting in NSAIDs intake||55.5|-4.1|
72517854|NCT03892707|144565554|SUPERIORITY|||||||0.986|||||||Wilcoxon (Mann-Whitney)|||NSAIDs intake during the study was analyzed. In order to calculate the total number of treatment days with NSAIDs, first, intersecting or adjacent records were collapsed, irrespective of the specific drug used; the duration of each of the resulting intake periods was determined as (End date - Start date + 1) and, finally, all individual duration values were summed up. In case medication intake was ongoing at the end of study, end date was imputed by the date of study completion.||||0.986
72517855|NCT03892707|144565557|SUPERIORITY|||||||0.921|||||||Wilcoxon (Mann-Whitney)|||Comparison of patient satisfaction with treatment between treatment groups after 5 days since the start of study treatment.||||0.921
72517856|NCT03892707|144565557|SUPERIORITY|||||||0.051|||||||Wilcoxon (Mann-Whitney)|||Comparison of patient satisfaction with treatment between treatment groups after 10 days since the start of study treatment||||0.051
72517857|NCT03892707|144565557|SUPERIORITY|||||||0.651|||||||Wilcoxon (Mann-Whitney)|||Comparison of patient satisfaction with treatment between treatment groups after 38 days since the start of study treatment||||0.651
72569469|NCT01383421|144669888|SUPERIORITY||LS Mean Difference|-1.686|STANDARD_ERROR_OF_MEAN|0.893||0.059|TWO_SIDED|||||Statistical significance was set at P = 0.05.|ANCOVA|LS mean difference and P value are from ANCOVA model adjusting for corresponding Baseline values.||Week 24||||0.059
72517858|NCT03892707|144565557|SUPERIORITY|||||||0.106|||||||Wilcoxon (Mann-Whitney)|||Comparison of patient satisfaction with treatment between treatment groups after 3 months since the start of study treatment||||0.106
72517859|NCT01807949|144565569|SUPERIORITY_OR_OTHER||Least Squares (LS) Mean Difference|2.62||||0.0004|TWO_SIDED|95.0|1.18|4.06|||MMRM|||Analysis was performed using mixed-effects model for repeated measures (MMRM) model including treatment, visit, and treatment-by-visit interaction as fixed effects with adjustments for sex (male versus female), age group at baseline (less than \[\<\] 18 versus greater than equal to \[\>=\]18 years old), and percent predicted FEV1 severity at Screening (\<70 versus \>=70).||4.06|1.18|0.0004
72517860|NCT01807949|144565569|SUPERIORITY_OR_OTHER||LS Mean Difference|3.0|||<|0.0001|TWO_SIDED|95.0|1.56|4.44|||MMRM|||Analysis was performed using MMRM model, as described in Statistical Analysis 1.||4.44|1.56|<0.0001
72517861|NCT01807949|144565570|SUPERIORITY_OR_OTHER||LS Mean Difference|4.42||||0.0007|TWO_SIDED|95.0|1.86|6.98|||MMRM|||Analysis was performed using MMRM model including treatment, visit, and treatment-by-visit interaction as fixed effects with adjustments for sex (male versus female), age group at baseline (\<18 versus \>=18 years old), and percent predicted FEV1 severity at Screening (\<70 versus \>=70).||6.98|1.86|0.0007
72517862|NCT01807949|144565570|SUPERIORITY_OR_OTHER||LS Mean Difference|5.25|||<|0.0001|TWO_SIDED|95.0|2.69|7.81|||MMRM|||Analysis was performed using MMRM model, as described in Statistical Analysis 1.||7.81|2.69|<0.0001
72517863|NCT01807949|144565571|SUPERIORITY_OR_OTHER||LS Mean Difference|0.41|||<|0.0001|TWO_SIDED|95.0|0.23|0.59|||MMRM|||Analysis was performed using MMRM model including treatment, visit, and treatment-by-visit interaction as fixed effects with adjustments for sex (male versus female), age group at baseline (\<18 versus \>=18 years old), percent predicted FEV1 severity at Screening (\<70 versus \>=70), and baseline BMI.||0.59|0.23|<0.0001
72517864|NCT01807949|144565571|SUPERIORITY_OR_OTHER||LS Mean Difference|0.36||||0.0001|TWO_SIDED|95.0|0.17|0.54|||MMRM|||Analysis was performed using MMRM model, as described in Statistical Analysis 1.||0.54|0.17|0.0001
72517865|NCT01807949|144565572|SUPERIORITY_OR_OTHER||LS Mean Difference|2.21||||0.1651|TWO_SIDED|95.0|-0.91|5.33|||MMRM|||Analysis was performed using MMRM model including treatment, visit, and treatment-by-visit interaction as fixed effects with adjustments for sex (male versus female), age group at baseline (\<18 versus \>=18 years old), percent predicted FEV1 severity at Screening (\<70 versus \>=70), and baseline CFQ-R respiratory domain score.||5.33|-0.91|0.1651
72517866|NCT01807949|144565572|SUPERIORITY_OR_OTHER||LS Mean Difference|2.85||||0.0736|TWO_SIDED|95.0|-0.27|5.98|||MMRM|||Analysis was performed using MMRM model, as described in Statistical Analysis 1.||5.98|-0.27|0.0736
72517867|NCT01807949|144565573|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.9568|||<|0.0001|TWO_SIDED|95.0|1.8829|4.6431||This test is considered nominally significant because a hierarchical procedure was used and was broken prior to this test.|Cochran-Mantel-Haenszel|||Odds Ratio (OR) and 95% confidence intervals (Cis) are Mantel-Haenszel estimates. P values are from a Cochran-Mantel-Haenszel test stratified by sex (male versus female), age group at baseline (\<18 versus \>=18 years old), and percent predicted FEV1 severity at Screening (\<70 versus \>=70).||4.6431|1.8829|<0.0001
72569470|NCT01383421|144669888|SUPERIORITY||LS Mean Difference|-2.697|STANDARD_ERROR_OF_MEAN|0.903||0.003|TWO_SIDED|||||Statistical significance was set at P = 0.05.|ANCOVA|LS mean difference and P value are from ANCOVA model adjusting for corresponding Baseline values.||Week 52||||0.003
72569471|NCT01383421|144669888|SUPERIORITY||LS Mean Difference|-2.447|STANDARD_ERROR_OF_MEAN|0.945||0.01|TWO_SIDED|||||Statistical significance was set at P = 0.05.|ANCOVA|LS mean difference and P value are from ANCOVA model adjusting for corresponding Baseline values.||Week 78||||0.010
72569472|NCT01383421|144669889|SUPERIORITY||LS Mean Difference|-1.791|STANDARD_ERROR_OF_MEAN|0.788||0.023|TWO_SIDED|||||Statistical significance was set at P = 0.05.|ANCOVA|LS mean difference and P value are from ANCOVA model adjusting for corresponding Baseline values.||Week 24||||0.023
72569473|NCT01383421|144669889|SUPERIORITY||LS Mean Difference|-2.549|STANDARD_ERROR_OF_MEAN|0.818||0.002|TWO_SIDED|||||Statistical significance was set at P = 0.05.|ANCOVA|LS mean difference and P value are from ANCOVA model adjusting for corresponding Baseline values.||Week 52||||0.002
72569474|NCT01383421|144669889|SUPERIORITY||LS Mean Difference|-2.734|STANDARD_ERROR_OF_MEAN|0.872||0.002|TWO_SIDED|||||Statistical significance was set at P = 0.05.|ANCOVA|LS mean difference and P value are from ANCOVA model adjusting for corresponding Baseline values.||Week 78||||0.002
72569475|NCT01383421|144669893|SUPERIORITY||LS Mean Difference|1.333|STANDARD_ERROR_OF_MEAN|2.725||0.625|TWO_SIDED|||||Statistical significance was set at P = 0.05.|ANCOVA|LS mean difference and P value are from ANCOVA model adjusting for corresponding Baseline values.||WPAI absenteeism||||0.625
72569476|NCT01383421|144669893|SUPERIORITY||LS Mean Difference|-0.824|STANDARD_ERROR_OF_MEAN|2.441||0.736|TWO_SIDED|||||Statistical significance was set at P = 0.05.|ANCOVA|LS mean difference and P value are from ANCOVA model adjusting for corresponding Baseline values.||WPAI presenteeism||||0.736
72517868|NCT01807949|144565573|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.3834||||0.0001|TWO_SIDED|95.0|1.5234|3.7286||This test is considered nominally significant because a hierarchical procedure was used and was broken prior to this test.|Cochran-Mantel-Haenszel|||Analysis was performed as described in Statistical Analysis 1.||3.7286|1.5234|0.0001
72569477|NCT01383421|144669893|SUPERIORITY||LS Mean Difference|1.207|STANDARD_ERROR_OF_MEAN|3.126||0.7|TWO_SIDED|||||Statistical significance was set at P = 0.05.|ANCOVA|LS mean difference and P value are from ANCOVA model adjusting for corresponding Baseline values.||WPAI overall work impairment||||0.700
72569478|NCT01383421|144669893|SUPERIORITY||LS Mean Difference|-3.552|STANDARD_ERROR_OF_MEAN|1.561||0.023|TWO_SIDED|||||Statistical significance was set at P = 0.05.|ANCOVA|LS mean difference and P value are from ANCOVA model adjusting for corresponding Baseline values.||WPAI activity impairment||||0.023
72569479|NCT01383421|144669894|SUPERIORITY||LS Mean Difference|0.38|STANDARD_ERROR_OF_MEAN|2.736||0.89|TWO_SIDED|||||Statistical significance was set at P = 0.05.|ANCOVA|LS mean difference and P value are from ANCOVA model adjusting for corresponding Baseline values.||WPAI absenteeism||||0.890
72517869|NCT01807949|144565574|SUPERIORITY_OR_OTHER||Event Rate Ratio|0.6912||||0.0116|TWO_SIDED|95.0|0.5187|0.9209||This test is considered nominally significant because a hierarchical procedure was used and was broken prior to this test.|Negative Binomial Regression|||Analysis was performed using regression analysis for a negative binomial distribution with sex (male versus female), age group at baseline (\<18 versus \>=18 years old), and percent predicted FEV1 severity at Screening (\<70 versus \>=70) as covariates with the logarithm of time on study as the offset.||0.9209|0.5187|0.0116
72405195|NCT03003520|144318238|SUPERIORITY|||||||0.662||||||Significance defined as 0.05.|Fisher Exact|||||||0.662
72492320|NCT00852995|144513161|SUPERIORITY_OR_OTHER|||||||0.8759|TWO_SIDED|||||Visit 06|Cochran-Mantel-Haenszel|||||||0.8759
72492321|NCT00852995|144513161|SUPERIORITY_OR_OTHER|||||||0.9008|TWO_SIDED|||||Visit 06|Cochran-Mantel-Haenszel|||||||0.9008
72492322|NCT00852995|144513161|SUPERIORITY_OR_OTHER|||||||0.4618|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.4618
72492323|NCT00852995|144513161|SUPERIORITY_OR_OTHER|||||||0.2439|TWO_SIDED|||||Visit 07|Cochran-Mantel-Haenszel|||||||0.2439
72492324|NCT00852995|144513161|SUPERIORITY_OR_OTHER|||||||0.749|TWO_SIDED|||||Visit 07|Cochran-Mantel-Haenszel|||||||0.749
72492325|NCT00852995|144513161|SUPERIORITY_OR_OTHER|||||||0.3749|TWO_SIDED|||||Visit 07|Cochran-Mantel-Haenszel|||||||0.3749
72492326|NCT00852995|144513161|SUPERIORITY_OR_OTHER|||||||0.015|TWO_SIDED|||||Visit 07|Cochran-Mantel-Haenszel|||||||0.015
72492327|NCT00852995|144513161|SUPERIORITY_OR_OTHER|||||||0.0078|TWO_SIDED|||||Visit 08|Cochran-Mantel-Haenszel|||||||0.0078
72492328|NCT00852995|144513161|SUPERIORITY_OR_OTHER|||||||0.07|TWO_SIDED|||||Visit 08|Cochran-Mantel-Haenszel|||||||0.07
72492329|NCT00852995|144513161|SUPERIORITY_OR_OTHER|||||||0.208|TWO_SIDED|||||Visit 08|Cochran-Mantel-Haenszel|||||||0.208
72569480|NCT01383421|144669894|SUPERIORITY||LS Mean Difference|-0.527|STANDARD_ERROR_OF_MEAN|2.523||0.835|TWO_SIDED|||||Statistical significance was set at P = 0.05.|ANCOVA|LS mean difference and P value are from ANCOVA model adjusting for corresponding Baseline values.||WPAI presenteeism||||0.835
72492330|NCT00852995|144513161|SUPERIORITY_OR_OTHER|||||||0.0413|TWO_SIDED|||||Visit 08|Cochran-Mantel-Haenszel|||||||0.0413
72492331|NCT00852995|144513161|SUPERIORITY_OR_OTHER|||||||0.0054|TWO_SIDED|||||Visit 09|Cochran-Mantel-Haenszel|||||||0.0054
72492332|NCT00852995|144513161|SUPERIORITY_OR_OTHER|||||||0.2031|TWO_SIDED|||||Visit 09|Cochran-Mantel-Haenszel|||||||0.2031
72492333|NCT00852995|144513161|SUPERIORITY_OR_OTHER|||||||0.0894|TWO_SIDED|||||Visit 09|Cochran-Mantel-Haenszel|||||||0.0894
72569481|NCT01383421|144669894|SUPERIORITY||LS Mean Difference|-0.471|STANDARD_ERROR_OF_MEAN|3.205||0.883|TWO_SIDED|||||Statistical significance was set at P = 0.05.|ANCOVA|LS mean difference and P value are from ANCOVA model adjusting for corresponding Baseline values.||WPAI overall work impairment||||0.883
72492334|NCT00852995|144513161|SUPERIORITY_OR_OTHER|||||||0.0288|TWO_SIDED|||||Visit 09|Cochran-Mantel-Haenszel|||||||0.0288
72492335|NCT00852995|144513161|SUPERIORITY_OR_OTHER|||||||0.6964|TWO_SIDED|||||Visit 10|Cochran-Mantel-Haenszel|||||||0.6964
72492336|NCT00852995|144513161|SUPERIORITY_OR_OTHER|||||||0.59|TWO_SIDED|||||Visit 10|Cochran-Mantel-Haenszel|||||||0.59
72492337|NCT00852995|144513161|SUPERIORITY_OR_OTHER|||||||0.7146|TWO_SIDED|||||Visit 10|Cochran-Mantel-Haenszel|||||||0.7146
72405196|NCT03003520|144318238|SUPERIORITY||AUC-ROC|0.6||||0.399|TWO_SIDED|||||Significance defined as 0.05.|Wilcoxon (Mann-Whitney)|||The Area Under the Receiver Operator Characteristic Curve (AUC-ROC) is the estimated parameter. Responders were compared to non-responders by ranking them according to their IFNG-Score.||||0.399
72492338|NCT00852995|144513161|SUPERIORITY_OR_OTHER|||||||0.5008|TWO_SIDED|||||Visit 10|Cochran-Mantel-Haenszel|||||||0.5008
72492339|NCT00852995|144513161|SUPERIORITY_OR_OTHER|||||||0.1235|TWO_SIDED|||||Visit 11|Cochran-Mantel-Haenszel|||||||0.1235
72492340|NCT00852995|144513161|SUPERIORITY_OR_OTHER|||||||0.5488|TWO_SIDED|||||Visit 11|Cochran-Mantel-Haenszel|||||||0.5488
72492341|NCT00852995|144513161|SUPERIORITY_OR_OTHER|||||||0.4343|TWO_SIDED|||||Visit 11|Cochran-Mantel-Haenszel|||||||0.4343
72492342|NCT00852995|144513161|SUPERIORITY_OR_OTHER|||||||0.1114|TWO_SIDED|||||Visit 11|Cochran-Mantel-Haenszel|||||||0.1114
72492343|NCT00852995|144513161|SUPERIORITY_OR_OTHER|||||||0.2119|TWO_SIDED|||||Visit 12|Cochran-Mantel-Haenszel|||||||0.2119
72492344|NCT00852995|144513161|SUPERIORITY_OR_OTHER|||||||0.0194|TWO_SIDED|||||Visit 12|Cochran-Mantel-Haenszel|||||||0.0194
72492345|NCT00852995|144513161|SUPERIORITY_OR_OTHER|||||||0.506|TWO_SIDED|||||Visit 12|Cochran-Mantel-Haenszel|||||||0.506
72492346|NCT00852995|144513161|SUPERIORITY_OR_OTHER|||||||0.2317|TWO_SIDED|||||Visit 12|Cochran-Mantel-Haenszel|||||||0.2317
72492347|NCT00852995|144513161|SUPERIORITY_OR_OTHER|||||||0.1144|TWO_SIDED|||||Visit 13|Cochran-Mantel-Haenszel|||||||0.1144
72492348|NCT00852995|144513161|SUPERIORITY_OR_OTHER|||||||0.6786|TWO_SIDED|||||Visit 13|Cochran-Mantel-Haenszel|||||||0.6786
72492349|NCT00852995|144513161|SUPERIORITY_OR_OTHER|||||||0.7735|TWO_SIDED|||||Visit 13|Cochran-Mantel-Haenszel|||||||0.7735
72492350|NCT00852995|144513161|SUPERIORITY_OR_OTHER|||||||0.758|TWO_SIDED|||||Visit 13|Cochran-Mantel-Haenszel|||||||0.758
72492351|NCT00852995|144513162|SUPERIORITY_OR_OTHER|||||||0.017|TWO_SIDED|||||Week 04|Cochran-Mantel-Haenszel|||||||0.017
72492352|NCT00852995|144513162|SUPERIORITY_OR_OTHER|||||||0.041|TWO_SIDED|||||Week 04|Cochran-Mantel-Haenszel|||||||.041
72492353|NCT00852995|144513162|SUPERIORITY_OR_OTHER|||||||0.017|TWO_SIDED|||||Week 05|Cochran-Mantel-Haenszel|||||||.017
72492354|NCT00852995|144513162|SUPERIORITY_OR_OTHER|||||||0.011|TWO_SIDED|||||Week 06|Cochran-Mantel-Haenszel|||||||.011
72492355|NCT00852995|144513162|SUPERIORITY_OR_OTHER|||||||0.014|TWO_SIDED|||||Week 07|Cochran-Mantel-Haenszel|||||||.014
72492356|NCT00852995|144513162|SUPERIORITY_OR_OTHER|||||||0.029|TWO_SIDED|||||Week 08|Cochran-Mantel-Haenszel|||||||.029
72492357|NCT00852995|144513162|SUPERIORITY_OR_OTHER|||||||0.021|TWO_SIDED|||||Week 09|Cochran-Mantel-Haenszel|||||||.021
72492358|NCT00852995|144513162|SUPERIORITY_OR_OTHER|||||||0.041|TWO_SIDED|||||Week 10|Cochran-Mantel-Haenszel|||||||.041
72492359|NCT00852995|144513162|SUPERIORITY_OR_OTHER|||||||0.044|TWO_SIDED|||||Week 10|Cochran-Mantel-Haenszel|||||||.044
72492360|NCT00852995|144513162|SUPERIORITY_OR_OTHER|||||||0.013|TWO_SIDED|||||Week 11|Cochran-Mantel-Haenszel|||||||.013
72492361|NCT00852995|144513162|SUPERIORITY_OR_OTHER|||||||0.024|TWO_SIDED|||||Week 11|Cochran-Mantel-Haenszel|||||||.024
72492362|NCT00852995|144513162|SUPERIORITY_OR_OTHER|||||||0.027|TWO_SIDED|||||Week 12|Cochran-Mantel-Haenszel|||||||.027
72492363|NCT00852995|144513164|SUPERIORITY_OR_OTHER|||||||0.0211|TWO_SIDED|||||P-value for Kaplan-Meier Days to Closure|ANCOVA|||||||0.0211
72492364|NCT00852995|144513164|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.83||||0.0212|TWO_SIDED|95.0|1.09|3.04|||Regression, Cox|||||3.04|1.09|.0212
72492365|NCT00852995|144513164|SUPERIORITY_OR_OTHER|||||||0.59|TWO_SIDED||||||ANCOVA|||||||0.59
72405197|NCT01332149|144318241|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) Mean Difference|-0.28|STANDARD_ERROR_OF_MEAN|0.148||0.0559|TWO_SIDED|95.0|-0.58|0.01||Primary analysis was two-sided and performed at the 0.05 significance level. No multiple comparisons adjustment was made.|ANCOVA|The ANCOVA model included treatment and study center as factors and the corresponding baseline score as a covariate in the model.||||0.01|-0.58|0.0559
72405198|NCT01332149|144318242|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.23|STANDARD_ERROR_OF_MEAN|0.12||0.0527|TWO_SIDED|95.0|-0.47|0.0||All analyses were two-sided and performed at the 0.05 significance level.|Mixed Model Repeated Measures Analysis|||Week 1 Modelled Results. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified.||0.00|-0.47|0.0527
72405199|NCT01332149|144318242|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.27|STANDARD_ERROR_OF_MEAN|0.121||0.0279|TWO_SIDED|95.0|-0.5|-0.03||All analyses were two-sided and performed at the 0.05 significance level.|Mixed Model Repeated Measures Analysis|||Week 2 Modelled Results. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified.||-0.03|-0.50|0.0279
72405200|NCT01332149|144318242|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.24|STANDARD_ERROR_OF_MEAN|0.121||0.0508|TWO_SIDED|95.0|-0.48|0.0||All analyses were two-sided and performed at the 0.05 significance level.|Mixed Model Repeated Measures Analysis|||Week 3 Modelled Results. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified.||0.00|-0.48|0.0508
72405201|NCT01332149|144318242|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.26|STANDARD_ERROR_OF_MEAN|0.121||0.0349|TWO_SIDED|95.0|-0.49|-0.02||All analyses were two-sided and performed at the 0.05 significance level.|Mixed Model Repeated Measures Analysis|||Week 4 Modelled Results. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified.||-0.02|-0.49|0.0349
72405202|NCT01332149|144318242|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.122||0.0672|TWO_SIDED|95.0|-0.46|0.02||All analyses were two-sided and performed at the 0.05 significance level.|Mixed Model Repeated Measures Analysis|||Week 5 Modelled Results. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified.||0.02|-0.46|0.0672
72405203|NCT01332149|144318242|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.24|STANDARD_ERROR_OF_MEAN|0.122||0.0469|TWO_SIDED|95.0|-0.48|0.0||All analyses were two-sided and performed at the 0.05 significance level.|Mixed Model Repeated Measures Analysis|||Week 6 Modelled Results. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified.||-0.00|-0.48|0.0469
72405204|NCT01332149|144318242|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.27|STANDARD_ERROR_OF_MEAN|0.122||0.028|TWO_SIDED|95.0|-0.51|-0.03||All analyses were two-sided and performed at the 0.05 significance level.|Mixed Model Repeated Measures Analysis|||Week 7 Modelled Results. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified.||-0.03|-0.51|0.0280
72405205|NCT01332149|144318242|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.122||0.014|TWO_SIDED|95.0|-0.54|-0.06||All analyses were two-sided and performed at the 0.05 significance level.|Mixed Model Repeated Measures Analysis|||Week 8 Modelled Results. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified.||-0.06|-0.54|0.0140
72405206|NCT01332149|144318242|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.25|STANDARD_ERROR_OF_MEAN|0.122||0.0375|TWO_SIDED|95.0|-0.49|-0.01||All analyses were two-sided and performed at the 0.05 significance level.|Mixed Model Repeated Measures Analysis|||Week 9 Modelled Results. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified.||-0.01|-0.49|0.0375
72405207|NCT01332149|144318242|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.25|STANDARD_ERROR_OF_MEAN|0.105||0.0164|TWO_SIDED|95.0|-0.46|-0.05||All analyses were two-sided and performed at the 0.05 significance level.|Mixed Model Repeated Measures Analysis||Overall change was estimated from the mixed effect model treatment main effect.|Overall change from baseline analysis. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified.||-0.05|-0.46|0.0164
72405208|NCT01332149|144318244|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.21|STANDARD_ERROR_OF_MEAN|0.143||0.134|TWO_SIDED|95.0|-0.49|0.07||Analysis was two-sided and performed at the 0.05 significance level.|ANCOVA|The ANCOVA model included treatment and study center as factors and the corresponding baseline score as a covariate in the model.||||0.07|-0.49|0.1340
72405209|NCT01332149|144318245|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.127||0.3438|TWO_SIDED|95.0|-0.37|0.13||Analysis was two-sided and performed at the 0.05 significance level.|Mixed Model Repeated Measures Analysis|||Week 1 Modelled Results. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified.||0.13|-0.37|0.3438
72405210|NCT01332149|144318245|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.128||0.2482|TWO_SIDED|95.0|-0.4|0.1||Analysis was two-sided and performed at the 0.05 significance level.|Mixed Model Repeated Measures Analysis|||Week 2 Modelled Results. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified.||0.10|-0.40|0.2482
72492366|NCT00852995|144513164|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.19||||0.53|TWO_SIDED|95.0|0.69|2.05||This is the P-value for the Cox Hazard Ratio|Regression, Cox|||||2.05|.69|0.53
72405211|NCT01332149|144318245|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.129||0.2249|TWO_SIDED|95.0|-0.41|0.1||Analysis was two-sided and performed at the 0.05 significance level.|Mixed Model Repeated Measures Analysis|||Week 3 Modelled Results. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified.||0.10|-0.41|0.2249
72405212|NCT01332149|144318245|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.21|STANDARD_ERROR_OF_MEAN|0.129||0.1094|TWO_SIDED|95.0|-0.46|0.05||Analysis was two-sided and performed at the 0.05 significance level.|Mixed Model Repeated Measures Analysis|||Week 4 Modelled Results. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified.||0.05|-0.46|0.1094
72405213|NCT01332149|144318245|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.129||0.2095|TWO_SIDED|95.0|-0.41|0.09||Analysis was two-sided and performed at the 0.05 significance level.|Mixed Model Repeated Measures Analysis|||Week 5 Modelled Results. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified.||0.09|-0.41|0.2095
72405214|NCT01332149|144318245|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.25|STANDARD_ERROR_OF_MEAN|0.129||0.0531|TWO_SIDED|95.0|-0.5|0.0||Analysis was two-sided and performed at the 0.05 significance level.|Mixed Model Repeated Measures Analysis|||Week 6 Modelled Results. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified.||0.00|-0.50|0.0531
72405215|NCT01332149|144318245|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.13||0.1628|TWO_SIDED|95.0|-0.44|0.07||Analysis was two-sided and performed at the 0.05 significance level.|Mixed Model Repeated Measures Analysis|||Week 7 Modelled Results. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified.||0.07|-0.44|0.1628
72405216|NCT01332149|144318245|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.23|STANDARD_ERROR_OF_MEAN|0.13||0.077|TWO_SIDED|95.0|-0.48|0.02||Analysis was two-sided and performed at the 0.05 significance level.|Mixed Model Repeated Measures Analysis|||Week 8 Modelled Results. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified.||0.02|-0.48|0.0770
72405217|NCT01332149|144318245|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.13||0.1651|TWO_SIDED|95.0|-0.43|0.07||Analysis was two-sided and performed at the 0.05 significance level.|Mixed Model Repeated Measures Analysis|||Week 9 Modelled Results. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified.||0.07|-0.43|0.1651
72492367|NCT00852995|144513164|SUPERIORITY_OR_OTHER|||||||0.26|TWO_SIDED||||||ANCOVA|Kaplan-Meier Days to Closure||||||0.26
72492368|NCT00852995|144513164|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.43||||0.19|TWO_SIDED|95.0|0.84|2.44||This is the P-value for the Cox Proportional Hazard Ratio|Regression, Cox|||||2.44|0.84|0.19
72405218|NCT01332149|144318245|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.11||0.1006|TWO_SIDED|95.0|-0.4|0.04||Analysis was two-sided and performed at the 0.05 significance level.|Mixed Model Repeated Measures Analysis|||Overall change from baseline analysis. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified.||0.04|-0.40|0.1006
72405219|NCT01332149|144318246|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.27||||0.1309|TWO_SIDED|95.0|0.93|1.74||Analysis was two-sided and performed at the 0.05 significance level.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test comparing pregabalin to placebo adjusted for center.||||1.74|0.93|0.1309
72405220|NCT01332149|144318249|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-3.25|STANDARD_ERROR_OF_MEAN|1.628||0.0463|TWO_SIDED|95.0|-6.45|-0.05||Analysis was two-sided and performed at the 0.05 significance level.|ANCOVA|The ANCOVA model included treatment and study center as factors and the corresponding baseline score as a covariate in the model.||||-0.05|-6.45|0.0463
72492369|NCT00852995|144513164|SUPERIORITY_OR_OTHER|||||||0.1|TWO_SIDED|||||P-value for Kaplan Meier Days to Closure|ANCOVA|||||||0.10
72492370|NCT00852995|144513164|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.64||||0.06|TWO_SIDED|95.0|0.97|2.77||P-value for Cox Proportional Hazard Ratio|Regression, Cox|||||2.77|0.97|0.06
72492371|NCT03649061|144513165|SUPERIORITY||||||<|0.05|||||||Mixed Models Analysis|||To compare the two randomization groups, a linear mixed model with DAS28-CRP as outcome (Bell et al. 2014), including random intercepts per patient, adjusted for baseline DAS28-CRP, randomization timepoint, and RF and/or ACPA seropositivity was used.||||<0.05
72492372|NCT03649061|144513166|SUPERIORITY||||||<|0.05|||||||Mixed Models Analysis|||A binomial generalized linear mixed effect model for repeated measures of remission from randomization up until 28 weeks after was carried out, with adjustment for baseline DAS28-CRP, moment of randomization, and RF and/or ACPA seropositivity.||||<0.05
72405221|NCT01332149|144318250|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.061||0.2748|TWO_SIDED|95.0|-0.19|0.05||Analysis was two-sided and performed at the 0.05 significance level.|ANCOVA|The ANCOVA model included treatment and study center as factors and the corresponding baseline score as a covariate in the model.||||0.05|-0.19|0.2748
72405222|NCT01332149|144318252|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.13|STANDARD_ERROR_OF_MEAN|1.577||0.4758|TWO_SIDED|95.0|-4.22|1.97||Analysis was two-sided and performed at the 0.05 significance level.|ANCOVA|The ANCOVA model included treatment and study center as factors and the corresponding baseline score as a covariate in the model.||||1.97|-4.22|0.4758
72405223|NCT01332149|144318253|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|3.31|STANDARD_ERROR_OF_MEAN|2.22||0.1363|TWO_SIDED|95.0|-1.05|7.67||Analysis was two-sided and performed at the 0.05 significance level.|ANCOVA|The ANCOVA model included treatment and study center as factors and the corresponding baseline score as a covariate in the model.||||7.67|-1.05|0.1363
72405224|NCT01332149|144318254|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.21|STANDARD_ERROR_OF_MEAN|1.371||0.8808|TWO_SIDED|95.0|-2.49|2.9||Analysis was two-sided and performed at the 0.05 significance level.|ANCOVA|The ANCOVA model included treatment and study center as factors and the corresponding baseline score as a covariate in the model.||||2.90|-2.49|0.8808
72405225|NCT01332149|144318255|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.19|STANDARD_ERROR_OF_MEAN|0.11||0.0887|TWO_SIDED|95.0|-0.03|0.4||Analysis was two-sided and performed at the 0.05 significance level.|ANCOVA|The ANCOVA model included treatment and study center as factors and the corresponding baseline score as a covariate in the model.||||0.40|-0.03|0.0887
72405226|NCT01332149|144318256|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.05||||0.7929|TWO_SIDED|95.0|0.72|1.53||Analysis was two-sided and performed at the 0.05 significance level.|Regression, Logistic|||Analysis performed using a logistic regression model with treatment and center as factors, and baseline value as a covariate.||1.53|0.72|0.7929
72405227|NCT01332149|144318257|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|1.05|STANDARD_ERROR_OF_MEAN|1.973||0.596|TWO_SIDED|95.0|-2.83|4.92||Analysis was two-sided and performed at the 0.05 significance level.|ANCOVA|The ANCOVA model included treatment and study center as factors and the corresponding baseline score as a covariate in the model.||||4.92|-2.83|0.5960
72405228|NCT01332149|144318258|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.35|STANDARD_ERROR_OF_MEAN|1.536||0.8216|TWO_SIDED|95.0|-3.36|2.67||Analysis was two-sided and performed at the 0.05 significance level.|ANCOVA|The ANCOVA model included treatment and study center as factors and the corresponding baseline score as a covariate in the model.||||2.67|-3.36|0.8216
72405229|NCT01332149|144318259|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.83|STANDARD_ERROR_OF_MEAN|1.177||0.4829|TWO_SIDED|95.0|-3.14|1.49||Analysis was two-sided and performed at the 0.05 significance level.|ANCOVA|The ANCOVA model included treatment and study center as factors and the corresponding baseline score as a covariate in the model.||||1.49|-3.14|0.4829
72405230|NCT01332149|144318260|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.073||0.0431|TWO_SIDED|95.0|-0.29|0.0||Analysis was two-sided and performed at the 0.05 significance level.|ANOVA|||Analysis performed using a general linear model with treatment and center as factors.||-0.00|-0.29|0.0431
72405231|NCT01332149|144318261|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.074||0.0602|TWO_SIDED|95.0|-0.28|0.01||Analysis was two-sided and performed at the 0.05 significance level.|ANOVA|||Analysis performed using a general linear model with treatment and center as factors.||0.01|-0.28|0.0602
72405232|NCT01332149|144318263|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.207||0.4172|TWO_SIDED|95.0|-0.57|0.24||Analysis was two-sided and performed at the 0.05 significance level.|ANCOVA|The ANCOVA model included treatment and study center as factors and the corresponding baseline score as a covariate in the model.||||0.24|-0.57|0.4172
72405233|NCT01332149|144318264|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.218||0.3724|TWO_SIDED|95.0|-0.62|0.23||Analysis was two-sided and performed at the 0.05 significance level.|ANCOVA|The ANCOVA model included treatment and study center as factors and the corresponding baseline score as a covariate in the model.||||0.23|-0.62|0.3724
72492373|NCT01314716|144513196|SUPERIORITY_OR_OTHER||Differences in least squares mean|4.6||||0.011|TWO_SIDED|95.0|1.1|8.2||P-value was based on T-test from mixed-effect model repeated measures (MMRM).|MMRM|||||8.2|1.1|0.011
72492374|NCT01314716|144513197|SUPERIORITY_OR_OTHER||Difference in least squares mean|1.1||||0.56|TWO_SIDED|95.0|-2.7|5.0||P-value was based on T-test from mixed-effect model repeated measures (MMRM).|MMRM|||||5.0|-2.7|0.56
72492375|NCT02049944|144513234|OTHER|we used t-test on the regression coefficient for the group indicator to test for differences in means categorical variables were evaluated using fisher's exact test of association linear regression for log transformed start adipose concentrations were calculated by dose specific group|Median Difference (Final Values)|80.0|||||TWO_SIDED|95.0|||||Fisher Exact|||To detect the number of subjects who obtained a minimal inhibitory concentration (\>4mg/ml) following increased 3g dose of cefazolin. Compare this number to the historical cohort who had received 2g of cefazolin (standard dosing)||||
72492376|NCT01765673|144513235|OTHER|||||||0.218|||||||paired t test|||||||0.218
72492377|NCT01765673|144513236|OTHER|||||||0.017|||||||paired t test|||||||0.017
72492378|NCT01765673|144513237|OTHER|||||||0.022|||||||paired t test|||||||0.022
72492379|NCT01765673|144513238|OTHER|||||||0.719|||||||paired t test|||||||0.719
72492380|NCT01765673|144513239|OTHER|||||||0.418|||||||paired t test|||||||0.418
72492381|NCT01765673|144513240|OTHER|||||||0.038|||||||paired t test|||||||0.038
72492382|NCT01765673|144513241|OTHER|||||||0.086|||||||paired t test|||||||0.086
72492383|NCT01765673|144513242|OTHER|||||||0.16|||||||paired t test|||||||0.16
72492384|NCT01765673|144513243|OTHER|||||||0.052|||||||paired t test|||||||0.052
72492385|NCT01765673|144513244|OTHER|||||||0.827|||||||paired t test|||||||0.827
72492386|NCT01765673|144513245|OTHER|||||||0.088|||||||paired t test|||||||0.088
72492387|NCT01765673|144513246|OTHER|||||||0.152|||||||paired t test|||||||0.152
72492388|NCT01765673|144513247|OTHER|||||||0.229|||||||paired t test|||||||0.229
72492389|NCT01765673|144513248|OTHER|||||||0.121|||||||paired t test|||||||0.121
72492390|NCT01765673|144513249|OTHER|||||||0.239|||||||paired t test|||||||0.239
72492391|NCT01765673|144513250|OTHER|||||||0.03|||||||paired t test|||||||0.03
72492392|NCT01765673|144513251|OTHER|||||||0.067|||||||paired t test|||||||0.067
72492393|NCT01765673|144513252|OTHER|||||||0.396|||||||paired t test|||||||0.396
72492394|NCT01765673|144513253|OTHER|||||||0.373|||||||paired t test|||||||0.373
72492395|NCT01765673|144513254|OTHER|||||||0.744|||||||paired t test|||||||0.744
72492396|NCT02600507|144513263|SUPERIORITY||Least Squares Mean Difference|-2.4|STANDARD_ERROR_OF_MEAN|1.03||0.021|TWO_SIDED|95.0|-4.42|-0.37|||Mixed Effects Model for Repeated Measure|||||-0.37|-4.42|0.021
72492397|NCT02600507|144513263|SUPERIORITY||Least Squares Mean Difference|-1.7|STANDARD_ERROR_OF_MEAN|1.01||0.099|TWO_SIDED|95.0|-3.65|0.32|||Mixed Effects Model for Repeated Measure|||||0.32|-3.65|0.099
72492398|NCT02600507|144513264|SUPERIORITY||Least Squares Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.13||0.008|TWO_SIDED|95.0|-0.59|-0.09|||Mixed Effects Model for Repeated Measure|||||-0.09|-0.59|0.008
72492399|NCT02600507|144513264|SUPERIORITY||Least Squares Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.12||0.04|TWO_SIDED|95.0|-0.5|-0.01|||Mixed Effects Model for Repeated Measure|||||-0.01|-0.50|0.040
72492400|NCT00621504|144513290|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% Confidence Interval (CI) for the observed difference in the primary outcome measure (clinical cure rate) between the ceftaroline group and the ceftriaxone group was calculated based on each of the CE and the MITTE Populations at the TOC visit. Noninferiority was concluded if the lower limit of the 95% CI was higher than -10% for each of the CE and MITTE Populations.|Risk Difference (RD)|6.2|||||TWO_SIDED|95.0|-0.2|12.6|||||Risk difference corresponds to Ceftaroline clinical cure rate minus Ceftriaxone clinical cure rate. The confidence interval was calculated using the Miettinen and Nurminen method without adjustment.|The primary objective of this study was to determine the noninferiority in the clinical cure rate for ceftaroline compared to that for ceftriaxone at TOC in the CE and MITTE Populations in adult subjects with CABP.||12.6|-0.2|
72492401|NCT03257267|144513315|SUPERIORITY||Hazard Ratio (HR)|0.665|||<|1e-05|TWO_SIDED|95.0|0.555|0.796||One-sided p-value|Stratified Log-rank Test|||||0.796|0.555|<0.00001
72492402|NCT03257267|144513316|SUPERIORITY||Hazard Ratio (HR)|0.741||||0.00031|TWO_SIDED|95.0|0.623|0.882|||Stratified Log-rank Test|||||0.882|0.623|0.00031
72492403|NCT03257267|144513317|SUPERIORITY||Odds Ratio (OR)|3.136||||2e-05|TWO_SIDED|95.0|1.798|5.468|||Stratified Cochran-Mantel-Haenszel test|||||5.468|1.798|0.00002
72492404|NCT03257267|144513322|SUPERIORITY||Hazard Ratio (HR)|0.698||||0.00024|TWO_SIDED|95.0|0.57|0.855||One-sided p-value|Stratified Log-rank Test|||||0.855|0.570|0.00024
72492405|NCT03657368|144513323|SUPERIORITY||Mean Difference (Final Values)|3.5||||0.042|TWO_SIDED|97.5|-0.4|7.3|||Regression, Linear|||||7.3|-0.4|0.042
72492406|NCT03657368|144513323|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.966|TWO_SIDED|97.5|-3.9|3.7|||Regression, Linear|||||3.7|-3.9|0.966
72492407|NCT03657368|144513324|SUPERIORITY||Odds Ratio (OR)|0.93||||0.519|TWO_SIDED|99.2|0.68|1.27|||Regression, Logistic|||||1.27|0.68|0.519
72492408|NCT03657368|144513324|SUPERIORITY||Odds Ratio (OR)|0.87||||0.232|TWO_SIDED|99.2|0.63|1.19|||Regression, Logistic|||||1.19|0.63|0.232
72492409|NCT03657368|144513325|SUPERIORITY||Mean Difference (Final Values)|-2.1||||0.217|TWO_SIDED|99.2|-6.5|2.4|||Regression, Linear|||||2.4|-6.5|0.217
72492410|NCT03657368|144513325|SUPERIORITY||Mean Difference (Final Values)|0.7||||0.66|TWO_SIDED|99.2|-3.7|5.2|||Regression, Linear|||||5.2|-3.7|0.660
72492411|NCT03657368|144513326|SUPERIORITY||mean ratio|1.03||||0.143|TWO_SIDED|99.2|0.97|1.1|||Mixed Models Analysis|||||1.10|0.97|0.143
72492412|NCT03657368|144513326|SUPERIORITY||mean ratio|0.99||||0.649|TWO_SIDED|99.2|0.93|1.05|||Regression, Logistic|||||1.05|0.93|0.649
72517870|NCT01807949|144565574|SUPERIORITY_OR_OTHER||Event Rate Ratio|0.5659||||0.0002|TWO_SIDED|95.0|0.4191|0.7641||This test is considered nominally significant because a hierarchical procedure was used and was broken prior to this test.|Negative Binomial Regression|||Analysis was performed as described in Statistical Analysis 1.||0.7641|0.4191|0.0002
72517871|NCT01807949|144565575|SUPERIORITY_OR_OTHER||LS Mean Difference|1.13|||<|0.0001|TWO_SIDED|95.0|0.62|1.64|||MMRM|||Analysis was performed using MMRM model including treatment, visit, and treatment-by-visit interaction as fixed effects with adjustments for sex (male versus female), age group at baseline (\<18 versus \>=18 years old), percent predicted FEV1 severity at Screening (\<70 versus \>=70), and baseline weight.||1.64|0.62|<0.0001
72492413|NCT01623271|144513329|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|||||||t-test, 2 sided|||||||>0.05
72492414|NCT01982292|144513336|SUPERIORITY_OR_OTHER||Difference in percentage|0.5|||>|0.9999|TWO_SIDED|90.0|-9.38|10.38|||Fisher Exact|||Difference in percentage of patients with positive antibody status||10.38|-9.38|>0.9999
72492415|NCT01982292|144513336|SUPERIORITY_OR_OTHER||Difference in percentage|-0.5|||||TWO_SIDED|90.0|-10.38|9.38||||||Difference in percentage of patients with negative antibody status||9.38|-10.38|
72492416|NCT00746252|144513354|OTHER|||||||0.495||||||Threshold of significance is p\<.05|t-test, 2 sided|||Comparison of mean weight gain between groups.||||.495
72492417|NCT01870401|144513369|NON_INFERIORITY|The protocol identified a non-inferiority bound equal to 0.12 (12%).|||||<|0.025|||||||Farrington and Manning|||The primary safety hypothesis is as follows: H0: pControl - pDCB ≥ and H1: pControl (alpha) pDCB \< where p is the success rate in each arm and (alpha) is the non-inferiority bound.||||<0.025
72492418|NCT01870401|144513370|SUPERIORITY|||||||0.0222|||||||Wald Test|One-sided Wald test based on model estimate of DCB treatment effect and subject as a random effect.||||||0.0222
72517872|NCT01807949|144565575|SUPERIORITY_OR_OTHER||LS Mean Difference|0.95||||0.0003|TWO_SIDED|95.0|0.43|1.46|||MMRM|||Analysis was performed as described in Statistical Analysis 1.||1.46|0.43|0.0003
72517873|NCT01807949|144565576|SUPERIORITY_OR_OTHER||LS Mean Difference|0.2313||||0.0005|TWO_SIDED|95.0|0.1037|0.3589|||MMRM|||Analysis was performed using MMRM model including treatment, visit, and treatment-by-visit interaction as fixed effects with adjustments for sex (male versus female), age group at baseline (\<18 versus \>=18 years old), percent predicted FEV1 severity at Screening (\<70 versus \>=70), and baseline BMI z-score.||0.3589|0.1037|0.0005
72492419|NCT02684981|144513396|OTHER||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|Wilcoxon signed rank test has been used for this analysis||Statistical analysis for median change in PACT-Q2 scores from V1 to V2||||< 0.0001
72492420|NCT02684981|144513396|OTHER||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|Wilcoxon signed rank test has been used for this analysis||Statistical analysis for median change in convenience PACT-Q2 scores from V1 to V3||||< 0.0001
72492421|NCT02684981|144513397|OTHER||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|Wilcoxon signed rank test has been used for this analysis||Statistical analysis for median change in satisfaction PACT-Q2 scores from V1 to V2||||< 0.0001
72492422|NCT02684981|144513397|OTHER||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|Wilcoxon signed rank test has been used for this analysis||Statistical analysis for median change in satisfaction PACT-Q2 scores from V1 to V3||||< 0.0001
72492423|NCT02684981|144513398|OTHER||Mean Difference (Net)|18.377|STANDARD_ERROR_OF_MEAN|0.514|<|0.001|||||||Mixed Models Analysis||The primary analysis of PACT-Q2 scores was based on the random intercept model, where the matched group is considered as a random effect, the treatment as a fixed effect and the score as the response variable.|Mean change in convenience PACT-Q2 scores between VKA and Pradaxa therapy at initiation stage (V2)||||< 0.001
72517874|NCT01807949|144565576|SUPERIORITY_OR_OTHER||LS Mean Difference|0.2217||||0.0006|TWO_SIDED|95.0|0.0961|0.3473|||MMRM|||Analysis was performed as described in Statistical Analysis 1.||0.3473|0.0961|0.0006
72492424|NCT02684981|144513398|OTHER||Mean Difference (Net)|23.341|STANDARD_ERROR_OF_MEAN|0.509|<|0.001|||||||Mixed Models Analysis||The primary analysis of PACT-Q2 scores was based on the random intercept model, where the matched group is considered as a random effect, the treatment as a fixed effect and the score as the response variable.|Mean change in convenience PACT-Q2 scores between VKA and Pradaxa therapy at continuation stage (V3)||||< 0.001
72492425|NCT02684981|144513399|OTHER||Mean Difference (Net)|15.884|STANDARD_ERROR_OF_MEAN|0.388|<|0.001|||||||Mixed Models Analysis||The primary analysis of PACT-Q2 scores was based on the random intercept model, where the matched group is considered as a random effect, the treatment as a fixed effect and the score as the response variable.|Mean change in satisfaction PACT-Q2 scores between VKA and Pradaxa therapy at initiation stage (V2)||||< 0.001
72492426|NCT02684981|144513399|OTHER||Mean Difference (Net)|19.011|STANDARD_ERROR_OF_MEAN|0.408|<|0.001|||||||Mixed Models Analysis||The primary analysis of PACT-Q2 scores was based on the random intercept model, where the matched group is considered as a random effect, the treatment as a fixed effect and the score as the response variable.|Mean change in satisfaction PACT-Q2 scores between VKA and Pradaxa therapy at continuation stage (V3)||||< 0.001
72492427|NCT02684981|144513407|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|Wilcoxon signed rank test has been used for this analysis||Median convenience and satisfaction PACT-Q2 scores at last assessment compared to second assessment||||< 0.001
72492428|NCT04623242|144513410|SUPERIORITY||Ratio|1.063|STANDARD_DEVIATION|0.059|||TWO_SIDED|||||A priori threshold for statistical significance||||||||
72492429|NCT04623242|144513410|SUPERIORITY||Ratio|1.255|STANDARD_DEVIATION|0.061|||TWO_SIDED|||||A priori threshold for statistical significance||||||||
72492430|NCT04623242|144513411|OTHER||Mean Difference (Final Values)|-0.27|STANDARD_ERROR_OF_MEAN|1.094||0.805|TWO_SIDED|95.0|-2.46|1.92|||t-test, 2 sided|||||1.92|-2.46|0.805
72492431|NCT04623242|144513412|OTHER||Mean Difference (Final Values)|-1.2|STANDARD_ERROR_OF_MEAN|1.823||0.512|TWO_SIDED|95.0|-4.83|2.43|||t-test, 2 sided|||Test of equality (any treatment difference)||2.43|-4.83|0.512
72492432|NCT04623242|144513413|OTHER|Test of equality (any treatment difference)|Median Difference (Final Values)|-0.641|STANDARD_ERROR_OF_MEAN|0.1115|<|0.001|TWO_SIDED|95.0|-0.864|-0.417|||t-test, 2 sided|||||-0.417|-0.864|<0.001
72492433|NCT04623242|144513414|OTHER|Test of equality (any difference in the proportion of increase in the endpoint)|Ratio|0.3443||||0.5573|TWO_SIDED||||||Chi-squared|||||||0.5573
72492434|NCT04623242|144513415|OTHER|Test of equality (any treatment difference)|Mean Difference (Final Values)|0.41|STANDARD_ERROR_OF_MEAN|1.092||0.707|TWO_SIDED|95.0|-1.77|2.6|||t-test, 2 sided|||||2.60|-1.77|0.707
72492435|NCT04623242|144513416|OTHER|Test of equality (any treatment difference)|Mean Difference (Final Values)|-0.47|STANDARD_ERROR_OF_MEAN|0.44||0.283|TWO_SIDED|95.0|-1.35|0.4|||t-test, 2 sided|||||0.40|-1.35|0.283
72492436|NCT04623242|144513417|OTHER|Test of equality (any treatment difference)|Mean Difference (Final Values)|0.36|STANDARD_ERROR_OF_MEAN|0.859||0.674|TWO_SIDED|95.0|-1.34|2.07|||t-test, 2 sided|||||2.07|-1.34|0.674
72492437|NCT04623242|144513418|OTHER|Test of equality (any treatment difference)|Mean Difference (Final Values)|-1.22|STANDARD_ERROR_OF_MEAN|1.828||0.507|TWO_SIDED|95.0|-4.86|2.42|||t-test, 2 sided|||||2.42|-4.86|0.507
72492438|NCT04623242|144513419|OTHER|Test of equality (any treatment difference)|Mean Difference (Final Values)|-1.02|STANDARD_ERROR_OF_MEAN|1.706||0.553|TWO_SIDED|95.0|-4.41|2.38|||t-test, 2 sided|||||2.38|-4.41|0.553
72492439|NCT04623242|144513420|OTHER|Test of equality (any treatment difference)|Mean Difference (Final Values)|-1.0|STANDARD_ERROR_OF_MEAN|0.596||0.098|TWO_SIDED|95.0|-2.18|0.19|||t-test, 2 sided|||||0.19|-2.18|0.098
72492440|NCT04623242|144513421|OTHER|Test of equality (any treatment difference)|Mean Difference (Final Values)|2.73|STANDARD_ERROR_OF_MEAN|1.98||0.173|TWO_SIDED|95.0|-1.22|6.68|||t-test, 2 sided|||||6.68|-1.22|0.173
72492441|NCT04623242|144513422|OTHER|Test of equality (any treatment difference)|Mean Difference (Final Values)|0.3|STANDARD_ERROR_OF_MEAN|3.998||0.94|TWO_SIDED|95.0|-8.1|8.71|||t-test, 2 sided|||||8.71|-8.10|0.940
72517875|NCT01807949|144565577|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.716||||0.0384|TWO_SIDED||||||Cox Proportional Hazard Regression|||Analysis was performed using Cox proportional hazard regression, time is the time-to-first event or censoring, with adjustment for sex (male versus female), age group at baseline (\<18 versus \>=18 years old), and percent predicted FEV1 severity at Screening (\<70 versus \>=70).||||0.0384
72492442|NCT04623242|144513423|OTHER|Test of equality (any treatment difference)|Mean Difference (Final Values)|3.07|STANDARD_ERROR_OF_MEAN|16.524||0.854|TWO_SIDED|95.0|-30.49|36.62|||t-test, 2 sided|||||36.62|-30.49|0.854
72492443|NCT04623242|144513424|OTHER|Test of equality (any treatment difference)|Mean Difference (Final Values)|4.88|STANDARD_ERROR_OF_MEAN|17.448||0.781|TWO_SIDED|95.0|-30.0|39.75|||t-test, 2 sided|||||39.75|-30.00|0.781
72492444|NCT04623242|144513425|OTHER|Test of equality (any treatment difference)|Mean Difference (Final Values)|-1.69|STANDARD_ERROR_OF_MEAN|4.21||0.689|TWO_SIDED|95.0|-10.05|6.67|||t-test, 2 sided|||||6.67|-10.05|0.689
72492445|NCT04623242|144513426|OTHER|Test of equality (any treatment difference)|Mean Difference (Final Values)|-0.49|STANDARD_ERROR_OF_MEAN|0.689||0.474|TWO_SIDED|95.0|-1.86|0.87|||t-test, 2 sided|||||0.87|-1.86|0.474
72492446|NCT04623242|144513427|OTHER|Test of equality (any treatment difference)|Mean Difference (Final Values)|-0.09|STANDARD_ERROR_OF_MEAN|0.637||0.886|TWO_SIDED|95.0|-1.36|1.17|||t-test, 2 sided|||||1.17|-1.36|0.886
72492447|NCT04623242|144513428|OTHER|Test of equality (any treatment difference)|Mean Difference (Final Values)|0.09|STANDARD_ERROR_OF_MEAN|0.556||0.873|TWO_SIDED|95.0|-1.03|1.2|||t-test, 2 sided|||||1.20|-1.03|0.873
72492448|NCT04623242|144513429|OTHER|Test of equality (any treatment difference)|Mean Difference (Final Values)|-1.42|STANDARD_ERROR_OF_MEAN|1.66||0.394|TWO_SIDED|95.0|-4.71|1.87|||t-test, 2 sided|||||1.87|-4.71|0.394
72492449|NCT04623242|144513430|OTHER|Test of equality (any treatment difference)|Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|1.063||0.776|TWO_SIDED|95.0|-2.41|1.81|||t-test, 2 sided|||||1.81|-2.41|0.776
72492450|NCT04623242|144513431|OTHER|Test of equality (any treatment difference)|Mean Difference (Final Values)|-0.98|STANDARD_ERROR_OF_MEAN|0.909||0.283|TWO_SIDED|95.0|-2.78|0.82|||t-test, 2 sided|||||0.82|-2.78|0.283
72492451|NCT04623242|144513432|OTHER|Test of equality (any treatment difference)|Mean Difference (Final Values)|-0.45|STANDARD_ERROR_OF_MEAN|0.947||0.634|TWO_SIDED|95.0|-2.33|1.42|||t-test, 2 sided|||||1.42|-2.33|0.634
72492452|NCT04623242|144513433|SUPERIORITY||Ratio|1.155|STANDARD_DEVIATION|0.074|||TWO_SIDED|||||A priori threshold for statistical significance||||||||
72405234|NCT01920932|144318299|SUPERIORITY||Binomial proportions|31.25|||||TWO_SIDED|90.0||||The comparison of the complete rate between the first 32 evaluable participants and the historical control of HOD99 unfavorable risk patients was estimated by the binomial proportions test.||||In the historical control (HOD99) 17% of patients had CR at week 8. Sample size for this objective is calculated based on a binomial distribution to test H0: p=17% vs. Ha: p\>17%, where p is the true CR rate after 2 cycles of AEPA. 32 patients are needed to detect 20% increase of CR rate with 80% power and 5% type I error. If it shows efficacy, the response results will be reported, and the study will continue to enroll for a total of 77 patients to assess response and EFS.||||
72569482|NCT01383421|144669894|SUPERIORITY||LS Mean Difference|-3.792|STANDARD_ERROR_OF_MEAN|1.611||0.019|TWO_SIDED|||||Statistical significance was set at P = 0.05.|ANCOVA|LS mean difference and P value are from ANCOVA model adjusting for corresponding Baseline values.||WPAI activity impairment||||0.019
72405235|NCT01920932|144318301|SUPERIORITY|||||||0.004|||||||Fisher Exact|||Comparison of proportion of patient's complete response rate between HLHR13 and HOD99 (NCT00145600) unfavorable risk arm 2 (UR2).||||0.004
72405236|NCT01920932|144318302|SUPERIORITY|||||||0.0008|||||||Log Rank|||The comparison of the EFS between HLHR13 and historical control of HOD99 unfavorable risk 2 arm (UR2) was done by the two-sample log-rank test.||||0.0008
72405237|NCT01920932|144318307|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||PedsQL v.3.0 Total Score-T2, completion of 2 cycles of chemotherapy (approximately 2 months)||||<.001
72405238|NCT01920932|144318307|SUPERIORITY|||||||0.002|||||||Wilcoxon (Mann-Whitney)|||PedsQL v.3.0 Total Score-T3, completion of 4 cycles of chemotherapy (approximately 4 months)||||0.002
72492453|NCT04623242|144513434|OTHER|Test of equality (any treatment difference)|Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.0562||0.726|TWO_SIDED|95.0|-0.093|0.132|||t-test, 2 sided|||||0.132|-0.093|0.726
72492454|NCT04623242|144513435|OTHER|Test of equality (any treatment difference)|Mean Difference (Final Values)|0.082|STANDARD_ERROR_OF_MEAN|0.1056||0.439|TWO_SIDED|95.0|-0.13|0.295|||t-test, 2 sided|||||0.295|-0.130|0.439
72492455|NCT04623242|144513436|OTHER|Test of equality (any treatment difference)|Mean Difference (Final Values)|0.001|STANDARD_ERROR_OF_MEAN|0.0168||0.967|TWO_SIDED|95.0|-0.034|0.033|||t-test, 2 sided|||||0.033|-0.034|0.967
72492456|NCT04623242|144513437|OTHER|Test of equality (any treatment difference)|Mean Difference (Final Values)|0.016|STANDARD_ERROR_OF_MEAN|0.0377||0.669|TWO_SIDED|95.0|-0.059|0.092|||t-test, 2 sided|||||0.092|-0.059|0.669
72492457|NCT04623242|144513438|OTHER|Test of equality (any treatment difference)|Mean Difference (Final Values)|-34.46|STANDARD_ERROR_OF_MEAN|116.419||0.768|TWO_SIDED|95.0|-264.14|195.22|||t-test, 2 sided|||||195.22|-264.14|0.768
72492458|NCT04623242|144513440|OTHER|Test of equality (any treatment difference)|Mean Difference (Final Values)|-2737.62|STANDARD_ERROR_OF_MEAN|6558.467||0.677|TWO_SIDED|95.0|-15678.06|10202.81|||t-test, 2 sided|||||10202.81|-15678.06|0.677
72492459|NCT04623242|144513441|OTHER|Test of equality (any treatment difference)|Mean Difference (Final Values)|-1078.32|STANDARD_ERROR_OF_MEAN|1788.474||0.547|TWO_SIDED|95.0|-4603.28|2446.64|||t-test, 2 sided|||||2446.64|-4603.28|0.547
72492460|NCT04623242|144513442|OTHER|Test of equality (any treatment difference)|Mean Difference (Final Values)|-1935.91|STANDARD_ERROR_OF_MEAN|385.538|<|0.001|TWO_SIDED|95.0|-2717.64|-1154.18|||t-test, 2 sided|||||-1154.18|-2717.64|<0.001
72492461|NCT04623242|144513443|OTHER|Test of equality (any treatment difference)|Mean Difference (Final Values)|-77.12|STANDARD_ERROR_OF_MEAN|23.014||0.003|TWO_SIDED|95.0|-124.56|-29.68|||t-test, 2 sided|||||-29.68|-124.56|0.003
72492462|NCT04623242|144513444|OTHER|Test of equality (any treatment difference)|Mean Difference (Final Values)|30.89|STANDARD_ERROR_OF_MEAN|35.54||0.388|TWO_SIDED|95.0|-40.04|101.83|||t-test, 2 sided|||||101.83|-40.04|0.388
72405239|NCT01920932|144318307|SUPERIORITY|||||||0.067|||||||Wilcoxon (Mann-Whitney)|||PedsQL v.3.0 Total Score-T4, completion of radiation (approximately 8 months)||||0.067
72405240|NCT01920932|144318307|SUPERIORITY|||||||0.115|||||||Wilcoxon (Mann-Whitney)|||PedsQL v.3.0 Pain and Hurt-T2, completion of 2 cycles of chemotherapy (approximately 2 months)||||0.115
72405241|NCT01920932|144318307|SUPERIORITY|||||||0.455|||||||Wilcoxon (Mann-Whitney)|||PedsQL v.3.0 Pain and Hurt-T3, completion of 4 cycles of chemotherapy (approximately 4 months)||||0.455
72405242|NCT01920932|144318307|SUPERIORITY|||||||0.636|||||||Wilcoxon (Mann-Whitney)|||PedsQL v.3.0 Pain and Hurt-T4, completion of radiation (approximately 8 months)||||0.636
72405243|NCT01920932|144318307|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||PedsQL v.3.0 Nausea-T2, completion of 2 cycles of chemotherapy (approximately 2 months)||||<.001
72492463|NCT04623242|144513445|OTHER|Test of equality (any treatment difference)|Mean Difference (Final Values)|-0.76|STANDARD_ERROR_OF_MEAN|6.624||0.909|TWO_SIDED|95.0|-13.97|12.45|||t-test, 2 sided|||||12.45|-13.97|0.909
72492464|NCT04623242|144513446|OTHER|Test of equality (any treatment difference)|Mean Difference (Final Values)|0.178|STANDARD_ERROR_OF_MEAN|0.0593||0.004|TWO_SIDED|95.0|0.059|0.296|||t-test, 2 sided|||||0.296|0.059|0.004
72492465|NCT04623242|144513447|OTHER|Test of equality (any treatment difference)|Mean Difference (Final Values)|-0.43|STANDARD_ERROR_OF_MEAN|1.355||0.754|TWO_SIDED|95.0|-3.21|2.35|||t-test, 2 sided|||||2.35|-3.21|0.754
72492466|NCT04623242|144513449|OTHER|Test of equality (any treatment difference)|Mean Difference (Final Values)|229362.3|STANDARD_ERROR_OF_MEAN|14863.08|<|0.001|TWO_SIDED|95.0|199264.32|259460.27|||t-test, 2 sided|||||259460.27|199264.32|<0.001
72492467|NCT04623242|144513450|OTHER|Test of equality (any treatment difference)|Mean Difference (Final Values)|32906.6|STANDARD_ERROR_OF_MEAN|1697.541|<|0.001|TWO_SIDED|95.0|29406.49|36406.72|||t-test, 2 sided|||||36406.72|29406.49|<0.001
72492468|NCT04623242|144513451|OTHER|Test of equality (any treatment difference)|Mean Difference (Final Values)|1286.35|STANDARD_ERROR_OF_MEAN|140.692|<|0.001|TWO_SIDED|95.0|1002.79|1569.9|||t-test, 2 sided|||||1569.90|1002.79|<0.001
72492469|NCT04623242|144513452|OTHER|Test of equality (any treatment difference)|Mean Difference (Final Values)|9867.26|STANDARD_ERROR_OF_MEAN|1212.232|<|0.001|TWO_SIDED|95.0|7419.38|12315.15|||t-test, 2 sided|||||12315.15|7419.38|<0.001
72492470|NCT00493870|144513481|OTHER|||||||0.05|||||||Log Rank|||||||0.05
72492471|NCT03605680|144513488|SUPERIORITY||Least Squares (LS ) Mean Difference|-3.15|||=|0.0193|TWO_SIDED|95.0|-5.79|-0.51|||MMRM||||The comparison between the centanafadine and the placebo group was tested at a significance level of 0.05.|-0.51|-5.79|=0.0193
72492472|NCT03605680|144513488|SUPERIORITY||LS Mean Difference|-2.74|||=|0.0392|TWO_SIDED|95.0|-5.35|-0.14|||MMRM|||||-0.14|-5.35|=0.0392
72492473|NCT03605680|144513489|SUPERIORITY||LS Mean Difference|-0.27|||=|0.0232|TWO_SIDED|95.0|-0.5|-0.04|||MMRM||||The comparison between the centanafadine and the placebo group was tested at a significance level of 0.05.|-0.04|-0.50|=0.0232
72492474|NCT03605680|144513489|SUPERIORITY||LS Mean Difference|-0.28|||=|0.0162|TWO_SIDED|95.0|-0.51|-0.05|||MMRM||||The comparison between the centanafadine and the placebo group was tested at a significance level of 0.05.|-0.05|-0.51|=0.0162
72492475|NCT00527605|144513496|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-14.23|||<|0.0001||95.0|-20.23|-8.22|||t-test, 2 sided||Dutasteride arm minus placebo arm.|||-8.22|-20.23|<0.0001
72492476|NCT01008280|144513542|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED|95.0|||||Wald Chi-squared|||This was an intent to treat analysis where Generalized Estimating Equations, using the Negative Binomial function, were used to test for group, time, and group by time effects for drinks, drinking days, and heavy drinking days. This analysis assessed time effects for the number of drinking days.||||<0.01
72492477|NCT01008280|144513542|SUPERIORITY_OR_OTHER||||||>|0.01|TWO_SIDED|95.0|||||Wald Chi-Squared|||This was an intent to treat analysis where Generalized Estimating Equations, using the Negative Binomial function, were used to test for group, time, and group by time effects for drinks, drinking days, and heavy drinking days. This analysis assessed group effects for the number of drinking days.||||>0.01
72492478|NCT01008280|144513542|SUPERIORITY_OR_OTHER||||||>|0.01|TWO_SIDED|95.0|||||Wald Chi-Squared|||This was an intent to treat analysis where Generalized Estimating Equations, using the Negative Binomial function, were used to test for group, time, and group by time effects for drinks, drinking days, and heavy drinking days. This analysis assessed time by group effects for the number of drinking days.||||>0.01
72492479|NCT01008280|144513543|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED|95.0|||||Wald Chi-Squared|||This was an intent to treat analysis where Generalized Estimating Equations, using the Negative Binomial function, were used to test for group, time, and group by time effects for drinks, drinking days, and heavy drinking days. This analysis assessed time effects for the number of drinks.||||<0.01
72517876|NCT01807949|144565577|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.533||||0.0003|TWO_SIDED||||||Cox Proportional Hazard Regression|||Analysis was performed as described in Statistical Analysis 1.||||0.0003
72517877|NCT01807949|144565578|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.6373||||0.0393|TWO_SIDED|95.0|0.416|0.9764|||Cochran-Mantel-Haenszel|||OR and 95% confidence intervals (CIs) are Mantel-Haenszel estimates. P values are from a Cochran-Mantel-Haenszel test stratified by sex (male versus female), age group at baseline (\<18 versus \>=18 years old), and percent predicted FEV1 severity at Screening (\<70 versus \>=70).||0.9764|0.4160|0.0393
72569483|NCT01383421|144669895|SUPERIORITY||LS Mean Difference|-0.409|STANDARD_ERROR_OF_MEAN|2.548||0.873|TWO_SIDED|||||Statistical significance was set at P = 0.05.|ANCOVA|LS mean difference and P value are from ANCOVA model adjusting for corresponding Baseline values.||WPAI absenteeism||||0.873
72405244|NCT01920932|144318307|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||PedsQL v.3.0 Nausea-T3, completion of 4 cycles of chemotherapy (approximately 4 months)||||<.001
72405245|NCT01920932|144318307|SUPERIORITY|||||||0.006|||||||Wilcoxon (Mann-Whitney)|||PedsQL v.3.0 Nausea-T4, completion of radiation (approximately 8 months)||||0.006
72517878|NCT01807949|144565578|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.4429||||0.0002|TWO_SIDED|95.0|0.2863|0.6851|||Cochran-Mantel-Haenszel|||Analysis was performed as described in Statistical Analysis 1.||0.6851|0.2863|0.0002
72569484|NCT01383421|144669895|SUPERIORITY||LS Mean Difference|-0.817|STANDARD_ERROR_OF_MEAN|2.598||0.753|TWO_SIDED|||||Statistical significance was set at P = 0.05.|ANCOVA|LS mean difference and P value are from ANCOVA model adjusting for corresponding Baseline values.||WPAI presenteeism||||0.753
72369291|NCT00611026|144248566|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.0||0.311|TWO_SIDED|95.0|-0.1|0.0|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment with baseline value as a covariate.|Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.|Treatment difference Tolterodine ER vs placebo at Week 12.||0.0|-0.1|0.3110
72369292|NCT00611026|144248566|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.0||0.0004|TWO_SIDED|95.0|-0.2|-0.1|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment with baseline value as a covariate.|Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.|Treatment difference Tolterodine ER vs Fesoterodine at Week 12.||-0.1|-0.2|0.0004
72369293|NCT00611026|144248567|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.5|STANDARD_ERROR_OF_MEAN|0.6||0.0136|TWO_SIDED|95.0|-2.7|-0.3|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and baseline value as a covariate.|Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.|Treatment difference fesoterodine vs placebo at Week 1.||-0.3|-2.7|0.0136
72492480|NCT01008280|144513543|SUPERIORITY_OR_OTHER||||||>|0.01|TWO_SIDED|95.0|||||Wald Chi-Squared|||This was an intent to treat analysis where Generalized Estimating Equations, using the Negative Binomial function, were used to test for group, time, and group by time effects for drinks, drinking days, and heavy drinking days. This analysis assessed group effects for the number of drinks.||||>0.01
72492481|NCT01008280|144513543|SUPERIORITY_OR_OTHER||||||>|0.01|TWO_SIDED|95.0|||||Wald Chi-Squared|||This was an intent to treat analysis where Generalized Estimating Equations, using the Negative Binomial function, were used to test for group, time, and group by time effects for drinks, drinking days, and heavy drinking days. This analysis assessed group by time effects for the number of drinks.||||>0.01
72492482|NCT01008280|144513544|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED|95.0|||||Wald Chi-Squared|||This was an intent to treat analysis where Generalized Estimating Equations, using the Negative Binomial function, were used to test for group, time, and group by time effects for drinks, drinking days, and heavy drinking days. This analysis assessed time effects for the number of heavy drinking days.||||<0.01
72492483|NCT01008280|144513544|SUPERIORITY_OR_OTHER||||||>|0.01|TWO_SIDED|95.0|||||Wald Chi-Squared|||This was an intent to treat analysis where Generalized Estimating Equations, using the Negative Binomial function, were used to test for group, time, and group by time effects for drinks, drinking days, and heavy drinking days. This analysis assessed group effects for the number of heavy drinking days.||||>0.01
72569485|NCT01383421|144669895|SUPERIORITY||LS Mean Difference|-2.334|STANDARD_ERROR_OF_MEAN|3.159||0.461|TWO_SIDED|||||Statistical significance was set at P = 0.05.|ANCOVA|LS mean difference and P value are from ANCOVA model adjusting for corresponding Baseline values.||WPAI overall work impairment||||0.461
72569486|NCT01383421|144669895|SUPERIORITY||LS Mean Difference|-5.537|STANDARD_ERROR_OF_MEAN|1.624|<|0.001|TWO_SIDED|||||Statistical significance was set at P = 0.05.|ANCOVA|LS mean difference and P value are from ANCOVA model adjusting for corresponding Baseline values.||WPAI activity impairment||||<0.001
72569487|NCT01383421|144669896|SUPERIORITY||LS Mean Difference|2.973|STANDARD_ERROR_OF_MEAN|1.245||0.017|TWO_SIDED|||||Statistical significance was set at P = 0.05.|ANCOVA|LS mean difference and P value are from ANCOVA model adjusting for corresponding Baseline values.||TSQM convenience||||0.017
72569488|NCT01383421|144669896|SUPERIORITY||LS Mean Difference|2.843|STANDARD_ERROR_OF_MEAN|2.042||0.164|TWO_SIDED|||||Statistical significance was set at P = 0.05.|ANCOVA|LS mean difference and P value are from ANCOVA model adjusting for corresponding Baseline values.||TSQM effectiveness||||0.164
72569489|NCT01383421|144669896|SUPERIORITY||LS Mean Difference|5.473|STANDARD_ERROR_OF_MEAN|1.866||0.003|TWO_SIDED|||||Statistical significance was set at P = 0.05.|ANCOVA|LS mean difference and P value are from ANCOVA model adjusting for corresponding Baseline values.||TSQM global satisfaction||||0.003
72569490|NCT01383421|144669896|SUPERIORITY||LS Mean Difference|1.705|STANDARD_ERROR_OF_MEAN|1.769||0.335|TWO_SIDED|||||Statistical significance was set at P = 0.05.|ANCOVA|LS mean difference and P value are from ANCOVA model adjusting for corresponding Baseline values.||TSQM side effects||||0.335
72569491|NCT01383421|144669897|SUPERIORITY||LS Mean Difference|2.728|STANDARD_ERROR_OF_MEAN|1.183||0.021|TWO_SIDED|||||Statistical significance was set at P = 0.05.|ANCOVA|LS mean difference and P value are from ANCOVA model adjusting for corresponding Baseline values.||TSQM convenience||||0.021
72569492|NCT01383421|144669897|SUPERIORITY||LS Mean Difference|3.124|STANDARD_ERROR_OF_MEAN|1.93||0.106|TWO_SIDED|||||Statistical significance was set at P = 0.05.|ANCOVA|LS mean difference and P value are from ANCOVA model adjusting for corresponding Baseline values.||TSQM effectiveness||||0.106
72405246|NCT01920932|144318307|SUPERIORITY|||||||0.099|||||||Wilcoxon (Mann-Whitney)|||PedsQL v.3.0 Procedural Anxiety-T2, completion of 2 cycles of chemotherapy (approximately 2 months)||||0.099
72405247|NCT01920932|144318307|SUPERIORITY|||||||0.05|||||||Wilcoxon (Mann-Whitney)|||PedsQL v.3.0 Procedural Anxiety-T3, completion of 4 cycles of chemotherapy (approximately 4 months)||||0.050
72569493|NCT01383421|144669897|SUPERIORITY||LS Mean Difference|5.572|STANDARD_ERROR_OF_MEAN|1.756||0.002|TWO_SIDED|||||Statistical significance was set at P = 0.05.|ANCOVA|LS mean difference and P value are from ANCOVA model adjusting for corresponding Baseline values.||TSQM global satisfaction||||0.002
72569494|NCT01383421|144669897|SUPERIORITY||LS Mean Difference|1.885|STANDARD_ERROR_OF_MEAN|1.704||0.269|TWO_SIDED|||||Statistical significance was set at P = 0.05.|ANCOVA|LS mean difference and P value are from ANCOVA model adjusting for corresponding Baseline values.||TSQM side effects||||0.269
72569495|NCT01383421|144669898|SUPERIORITY||LS Mean Difference|2.324|STANDARD_ERROR_OF_MEAN|1.177||0.049|TWO_SIDED|||||Statistical significance was set at P = 0.05.|ANCOVA|LS mean difference and P value are from ANCOVA model adjusting for corresponding Baseline values.||TSQM convenience||||0.049
72569496|NCT01383421|144669898|SUPERIORITY||LS Mean Difference|4.929|STANDARD_ERROR_OF_MEAN|1.929||0.011|TWO_SIDED|||||Statistical significance was set at P = 0.05.|ANCOVA|LS mean difference and P value are from ANCOVA model adjusting for corresponding Baseline values.||TSQM effectiveness||||0.011
72569497|NCT01383421|144669898|SUPERIORITY||LS Mean Difference|5.997|STANDARD_ERROR_OF_MEAN|1.775|<|0.001|TWO_SIDED|||||Statistical significance was set at P = 0.05.|ANCOVA|LS mean difference and P value are from ANCOVA model adjusting for corresponding Baseline values.||TSQM global satisfaction||||<0.001
72569498|NCT01383421|144669898|SUPERIORITY||LS Mean Difference|1.823|STANDARD_ERROR_OF_MEAN|1.657||0.272|TWO_SIDED|||||Statistical significance was set at P = 0.05.|ANCOVA|LS mean difference and P value are from ANCOVA model adjusting for corresponding Baseline values.||TSQM side effects||||0.272
72405248|NCT01920932|144318307|SUPERIORITY|||||||0.52|||||||Wilcoxon (Mann-Whitney)|||PedsQL v.3.0 Procedural Anxiety-T4, completion of radiation (approximately 8 months)||||0.520
72405249|NCT01920932|144318307|SUPERIORITY|||||||0.024|||||||Wilcoxon (Mann-Whitney)|||PedsQL v.3.0 Treatment Anxiety-T2, completion of 2 cycles of chemotherapy (approximately 2 months)||||0.024
72405250|NCT01920932|144318307|SUPERIORITY|||||||0.011|||||||Wilcoxon (Mann-Whitney)|||PedsQL v.3.0 Treatment Anxiety-T3, completion of 4 cycles of chemotherapy (approximately 4 months)||||0.011
72405251|NCT01920932|144318307|SUPERIORITY|||||||0.009|||||||Wilcoxon (Mann-Whitney)|||PedsQL v.3.0 Treatment Anxiety-T4, completion of radiation (approximately 8 months)||||0.009
72569499|NCT01383421|144669899|SUPERIORITY||LS Mean Difference|0.817|STANDARD_ERROR_OF_MEAN|0.572||0.154|TWO_SIDED|||||Statistical significance was set at P = 0.05.|ANCOVA|LS mean difference and P value are from ANCOVA model adjusting for corresponding Baseline values.||Week 24||||0.154
72569500|NCT01383421|144669899|SUPERIORITY||LS Mean Difference|0.772|STANDARD_ERROR_OF_MEAN|0.599||0.198|TWO_SIDED|||||Statistical significance was set at P = 0.05.|ANCOVA|LS mean difference and P value are from ANCOVA model adjusting for corresponding Baseline values.||Week 52||||0.198
72569501|NCT01383421|144669899|SUPERIORITY||LS Mean Difference|0.884|STANDARD_ERROR_OF_MEAN|0.585||0.131|TWO_SIDED|||||Statistical significance was set at P = 0.05.|ANCOVA|LS mean difference and P value are from ANCOVA model adjusting for corresponding Baseline values.||Week 78||||0.131
72569502|NCT01383421|144669903|SUPERIORITY||LS Mean Between Group Change|0.1|STANDARD_ERROR_OF_MEAN|0.0429||0.019|TWO_SIDED|||||Statistical significance was set at P = 0.05.|ANCOVA|P value is from an ANCOVA model adjusting for Baseline.||Necessity||||0.019
72569503|NCT01383421|144669903|SUPERIORITY||LS Mean Between Group Change|0.0|STANDARD_ERROR_OF_MEAN|0.0526||0.56|TWO_SIDED|||||Statistical significance was set at P = 0.05.|ANCOVA|P value is from an ANCOVA model adjusting for Baseline.||Concern||||0.560
72569504|NCT01461226|144669955|OTHER|Mixed models analysis|mixed models|0.04|||<|0.05|TWO_SIDED||||||Mixed Models Analysis|||||||<0.05
72569505|NCT01461226|144669955|OTHER||mixed models|0.24||||0.64|TWO_SIDED|||||Baseline difference between groups|Mixed Models Analysis|||||||0.64
72569506|NCT01461226|144669955|OTHER|Mixed models|Slope|0.27||||0.6|TWO_SIDED||||||Mixed Models Analysis|||||||0.60
72405252|NCT01920932|144318307|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||PedsQL v.3.0 Worry-T2, completion of 2 cycles of chemotherapy (approximately 2 months)||||<.001
72569507|NCT01461226|144669955|OTHER|mixed models|mixed models|4.2||||0.04|TWO_SIDED||||||Mixed Models Analysis|||change after 10 months between groups||||0.04
72405253|NCT01920932|144318307|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||PedsQL v.3.0 Worry-T3, completion of 4 cycles of chemotherapy (approximately 4 months)||||<.001
72405254|NCT01920932|144318307|SUPERIORITY|||||||0.035|||||||Wilcoxon (Mann-Whitney)|||PedsQL v.3.0 Worry-T4, completion of radiation (approximately 8 months)||||0.035
72492484|NCT01008280|144513544|SUPERIORITY_OR_OTHER||||||>|0.01|TWO_SIDED|95.0|||||Wald Chi-Squared|||This was an intent to treat analysis where Generalized Estimating Equations, using the Negative Binomial function, were used to test for group, time, and group by time effects for drinks, drinking days, and heavy drinking days. This analysis assessed group by time effects for the number of heavy drinking days.||||>0.01
72569508|NCT00062010|144669958|SUPERIORITY_OR_OTHER_LEGACY||Overall Response Percentage|8.8|||||TWO_SIDED|90.0|2.4|21.3||||||The study was designed to have adequate (90%) power to distinguish a true response rate of 50% from a null rate of 35% assuming total accrual of 76 patients in two stages. The design mandated that at least 13 objective responses be observed among 34 patients in the first stage in order to continue to the second stage. These were not observed, so the study stopped after the first stage. 90% exact binomial confidence intervals are provided for the response rate.||21.3|2.4|
72405255|NCT01920932|144318307|SUPERIORITY|||||||0.037|||||||Wilcoxon (Mann-Whitney)|||PedsQL v.3.0 Cognitive Problems-T2, completion of 2 cycles of chemotherapy (approximately 2 months)||||0.037
72405256|NCT01920932|144318307|SUPERIORITY|||||||0.043|||||||Wilcoxon (Mann-Whitney)|||PedsQL v.3.0 Cognitive Problems-T3, completion of 4 cycles of chemotherapy (approximately 4 months)||||0.043
72405257|NCT01920932|144318307|SUPERIORITY|||||||0.044|||||||Wilcoxon (Mann-Whitney)|||PedsQL v.3.0 Cognitive Problems-T4, completion of radiation (approximately 8 months)||||0.044
72405258|NCT01920932|144318307|SUPERIORITY|||||||0.091|||||||Wilcoxon (Mann-Whitney)|||PedsQL v.3.0 Perceived Physical Appearance-T2, completion of 2 cycles of chemotherapy (approximately 2 months)||||0.091
72405259|NCT01920932|144318307|SUPERIORITY|||||||0.248|||||||Wilcoxon (Mann-Whitney)|||PedsQL v.3.0 Perceived Physical Appearance-T3, completion of 4 cycles of chemotherapy (approximately 4 months)||||0.248
72405260|NCT01920932|144318307|SUPERIORITY|||||||0.069|||||||Wilcoxon (Mann-Whitney)|||PedsQL v.3.0 Perceived Physical Appearance-T4, completion of radiation (approximately 8 months)||||0.069
72405261|NCT01920932|144318307|SUPERIORITY|||||||0.01|||||||Wilcoxon (Mann-Whitney)|||PedsQL v.3.0 Communication-T2, completion of 2 cycles of chemotherapy (approximately 2 months)||||0.010
72405262|NCT01920932|144318307|SUPERIORITY|||||||0.292|||||||Wilcoxon (Mann-Whitney)|||PedsQL v.3.0 Communication-T3, completion of 4 cycles of chemotherapy (approximately 4 months)||||0.292
72405263|NCT01920932|144318307|SUPERIORITY|||||||0.429|||||||Wilcoxon (Mann-Whitney)|||PedsQL v.3.0 Communication-T4, completion of radiation (approximately 8 months)||||0.429
72405264|NCT01920932|144318308|SUPERIORITY|||||||0.975|||||||Wilcoxon (Mann-Whitney)|||PedsQL v.4.0 Total Score-T1, At Diagnosis (baseline)||||0.975
72492485|NCT01968460|144513545|SUPERIORITY||Mean Difference (Net)|-4.67|STANDARD_ERROR_OF_MEAN|1.28||0.0004|TWO_SIDED|95.0|-7.2|-2.13||The overall significance level for this study will be 5% using two-tailed tests utilizing the hierarchical gate keeping approach to control the overall Type-I error rate in the strong sense.|MMRM|||||-2.13|-7.20|0.0004
72492486|NCT01968460|144513545|SUPERIORITY||Mean Difference (Net)|-3.84|STANDARD_ERROR_OF_MEAN|1.25||0.0027|TWO_SIDED|95.0|-6.32|-1.36||The overall significance level for this study will be 5% using two-tailed tests utilizing the hierarchical gate keeping approach to control the overall Type-I error rate in the strong sense.|MMRM|||||-1.36|-6.32|0.0027
72492487|NCT01968460|144513546|SUPERIORITY||Mean Difference (Net)|-1.85|STANDARD_ERROR_OF_MEAN|0.51||0.0004|TWO_SIDED|95.0|-2.86|-0.84||The overall significance level for this study will be 5% using two-tailed tests utilizing the hierarchical gate keeping approach to control the overall Type-I error rate in the strong sense.|MMRM|||||-0.84|-2.86|0.0004
72492488|NCT01968460|144513546|SUPERIORITY||Mean Difference (Net)|-1.42|STANDARD_ERROR_OF_MEAN|0.01||0.005|TWO_SIDED|95.0|-2.41|0.44||The overall significance level for this study will be 5% using two-tailed tests utilizing the hierarchical gate keeping approach to control the overall Type-I error rate in the strong sense.|MMRM|||||0.44|-2.41|0.005
72492489|NCT01968460|144513547|SUPERIORITY||Odds Ratio (OR)|8.1||||0.0165|TWO_SIDED|95.0|1.47|44.77||The overall significance level for this study was 5% using two-tailed tests.|Regression, Logistic|||A subject will be defined as a treatment responder in case that the improvement from baseline to the Week12 / Last Observed Value (LOV) in the CGI-S will be of 1 point or more. Baseline adjusted logistic regression (SAS® LOGISTIC procedure) stratified by GeoSite using the STRATA sub-command with the following effects: treatment group and baseline CGI-S measurement was used to test the between the active groups and placebo contrasts.||44.77|1.47|0.0165
72492490|NCT01968460|144513547|SUPERIORITY||Odds Ratio (OR)|4.23|STANDARD_ERROR_OF_MEAN|0.9||0.111|TWO_SIDED|95.0|0.72|24.9||The overall significance level for this study will be 5% using two-tailed tests.|Regression, Logistic|||||24.90|0.72|0.111
72492491|NCT01968460|144513548|SUPERIORITY||Mean Difference (Net)|-2.81|STANDARD_ERROR_OF_MEAN|1.0||0.0058|TWO_SIDED|95.0|-4.8|-0.83||The overall significance level for this study will be 5% using two-tailed tests utilizing the hierarchical gate keeping approach to control the overall Type-I error rate in the strong sense.|MMRM|||||-0.83|-4.80|0.0058
72492492|NCT01968460|144513548|SUPERIORITY||Mean Difference (Net)|-2.32|STANDARD_ERROR_OF_MEAN|0.98||0.0191|TWO_SIDED|95.0|-4.26|-0.39||The overall significance level for this study will be 5% using two-tailed tests utilizing the hierarchical gate keeping approach to control the overall Type-I error rate in the strong sense.|MMRM|||||-0.39|-4.26|0.0191
72492493|NCT01968460|144513549|SUPERIORITY||Mean Difference (Net)|-3.27|STANDARD_ERROR_OF_MEAN|1.24||0.0097|TWO_SIDED|95.0|-5.72|-0.8||The overall significance level for this study will be 5% using two-tailed tests utilizing the hierarchical gate keeping approach to control the overall Type-I error rate in the strong sense.|Mixed Models Analysis|||||-0.80|-5.72|0.0097
72492494|NCT01968460|144513549|SUPERIORITY||Mean Difference (Net)|-2.45|STANDARD_ERROR_OF_MEAN|1.24||0.0509|TWO_SIDED|95.0|-4.91|-0.012||The overall significance level for this study will be 5% using two-tailed tests utilizing the hierarchical gate keeping approach to control the overall Type-I error rate in the strong sense.|Mixed Models Analysis|||||-0.012|-4.91|0.0509
72517879|NCT01807949|144565579|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.0028||||0.7679|TWO_SIDED|95.0|-0.0211|0.0156|||MMRM|||Analysis was performed using MMRM model including treatment, visit, and treatment-by-visit interaction as fixed effects with adjustments for sex (male versus female), age group at baseline (\<18 versus \>=18 years old), percent predicted FEV1 severity at Screening (\<70 versus \>=70), and baseline EQ-5D-3L index score.||0.0156|-0.0211|0.7679
72517880|NCT01807949|144565579|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.0009||||0.9214|TWO_SIDED|95.0|-0.0192|0.0174|||MMRM|||Analysis was performed as described in Statistical Analysis 1.||0.0174|-0.0192|0.9214
72517881|NCT01807949|144565580|SUPERIORITY_OR_OTHER||LS Mean Difference|2.4||||0.1034|TWO_SIDED|95.0|-0.5|5.3|||MMRM|||Analysis was performed using MMRM model including treatment, visit, and treatment-by-visit interaction as fixed effects with adjustments for sex (male versus female), age group at baseline (\<18 versus \>=18 years old), percent predicted FEV1 severity at Screening (\<70 versus \>=70), and baseline EQ-5D-3L VAS score.||5.3|-0.5|0.1034
72517882|NCT01807949|144565580|SUPERIORITY_OR_OTHER||LS Mean Difference|3.3||||0.0262|TWO_SIDED|95.0|0.4|6.2|||MMRM|||Analysis was performed as described in Statistical Analysis 1.||6.2|0.4|0.0262
72517883|NCT01807949|144565581|SUPERIORITY_OR_OTHER||LS Mean Difference|8.64||||0.0005|TWO_SIDED|95.0|3.77|13.51|||MMRM|||Effectiveness: analysis was performed using MMRM model including treatment, visit, and treatment-by-visit interaction as fixed effects with adjustments for sex (male versus female), age group at baseline (\<18 versus \>=18 years old), percent predicted FEV1 severity at Screening (\<70 versus \>=70), and baseline TSQM effectiveness score.||13.51|3.77|0.0005
72492495|NCT00179309|144513550|SUPERIORITY_OR_OTHER|||||||0.12|ONE_SIDED|95.0||||Multiple comparisons were not done.|Log Rank|||48 evaluable pts will be randomized in a 1:1 ratio between two arms (24 evaluable pts per arm). Using standard formulae (e.g. nQuery Advisor v5), this number was selected to provide 80% power to detect a difference between 4.2 month median progression free survival (PFS) on the docetaxel alone arm and 8 month median PFS on the arm receiving PANVAC plus docetaxel, with a one-tailed alpha=0.10,assuming 36 months accrual and an additional 12 months of follow-up after the last pt has been enrolled.||||0.12
72492496|NCT02797808|144513557|SUPERIORITY||||||<|0.0083||||||Independent-sample t tests were used to compare the RSFC metrics between groups at baseline and 12 weeks. Bonferroni correction was applied to the alpha level (2-tailed, p\<.05/6= .0083) for multiple testing.|ANOVA|||||||<0.0083
72517884|NCT01807949|144565581|SUPERIORITY_OR_OTHER||LS Mean Difference|11.61|||<|0.0001|TWO_SIDED|95.0|6.75|16.48|||MMRM|||Effectiveness: analysis was performed as described in Statistical Analysis 1.||16.48|6.75|<0.0001
72517885|NCT01807949|144565581|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.18||||0.0403|TWO_SIDED|95.0|-6.21|-0.14|||MMRM|||Side Effects: analysis was performed using MMRM model including treatment, visit, and treatment-by-visit interaction as fixed effects with adjustments for sex (male versus female), age group at baseline (\<18 versus \>=18 years old), percent predicted FEV1 severity at Screening (\<70 versus \>=70), and baseline TSQM side effects score.||-0.14|-6.21|0.0403
72517886|NCT01807949|144565581|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.29||||0.0054|TWO_SIDED|95.0|-7.31|-1.28|||MMRM|||Side Effects: analysis was performed as described in Statistical Analysis 1.||-1.28|-7.31|0.0054
72517887|NCT01807949|144565581|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0||||1|TWO_SIDED|95.0|-4.07|4.07|||MMRM|||Convenience: analysis was performed using MMRM model including treatment, visit, and treatment-by-visit interaction as fixed effects with adjustments for sex (male versus female), age group at baseline (\<18 versus \>=18 years old), percent predicted FEV1 severity at Screening (\<70 versus \>=70), and baseline TSQM convenience score.||4.07|-4.07|1.0000
72517888|NCT01807949|144565581|SUPERIORITY_OR_OTHER||LS Mean Difference|0.32||||0.8777|TWO_SIDED|95.0|-3.74|4.37|||MMRM|||Convenience: analysis was performed as described in Statistical Analysis 1.||4.37|-3.74|0.8777
72517889|NCT01807949|144565581|SUPERIORITY_OR_OTHER||LS Mean Difference|4.64||||0.0668|TWO_SIDED|95.0|-0.32|9.61|||MMRM|||Global Satisfaction: analysis was performed using MMRM model including treatment, visit, and treatment-by-visit interaction as fixed effects with adjustments for sex (male versus female), age group at baseline (\<18 versus \>=18 years old), percent predicted FEV1 severity at Screening (\<70 versus \>=70), and baseline TSQM global satisfaction score.||9.61|-0.32|0.0668
72492497|NCT01780831|144513562|OTHER|Point and 90% CI estimates of percentage Cohort 1 infants who died or had grade 3/4 AE through 6 weeks of life.|Clopper-Pearson Confidence Interval (CI)|25.0|||||TWO_SIDED|90.0|9.0|48.4||||||||48.4|9|
72517890|NCT01807949|144565581|SUPERIORITY_OR_OTHER||LS Mean Difference|7.16||||0.0045|TWO_SIDED|95.0|2.23|12.08|||MMRM|||Global Satisfaction: analysis was performed as described in Statistical Analysis 1.||12.08|2.23|0.0045
72517891|NCT02141217|144565660|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of non-inferiority was based on Farrington and Manning method. The upper limit of two-sided 95% confidence interval of less than 10 % provide enough evidence to show the non-inferiority between the treatment arms.|Treatment Difference (percentage)|1.5|||||TWO_SIDED|95.0|-4.9|8.0||||||||8.0|-4.9|
72517892|NCT02141217|144565661|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of non-inferiority was based on Farrington and Manning method. The upper limit of two-sided 95% confidence interval of less than 10 % provide enough evidence to show the non-inferiority between the treatment arms.|Treatment Difference (percentage)|0.9|||||TWO_SIDED|95.0|-5.6|7.4||||||||7.4|-5.6|
72492498|NCT01780831|144513562|OTHER|Point and 90% CI estimates of percentage Cohort 2 infants who died or had grade 3/4 AE through 6 weeks of life.|Clopper-Pearson Confidence Interval (CI)|31.0|||||TWO_SIDED|90.0|18.7|46.6||||||||46.6|18.7|
72517893|NCT02141217|144565662|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of non-inferiority was based on Farrington and Manning method. The upper limit of two-sided 95% confidence interval of less than 10 % provide enough evidence to show the non-inferiority between the treatment arms.|Treatment Difference (percentage)|2.3|||||TWO_SIDED|95.0|-4.4|9.0||||||||9.0|-4.4|
72517894|NCT01181141|144565677|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|-3.5|||||TWO_SIDED|95.0|-18.8|6.0|||Wilcoxon (Mann-Whitney)|||||6.0|-18.8|
72492499|NCT01780831|144513569|OTHER|Point and 90% CI estimates of percentage Cohort 1 infants who died or had grade 3/4 AE through 24 weeks of life.|Clopper-Pearson Confidence Interval (CI)|25.0|||||TWO_SIDED|90.0|9.0|48.4||||||||48.4|9|
72492500|NCT01780831|144513569|OTHER|Point and 90% CI estimates of percentage Cohort 2 infants who died or had grade 3/4 AE through 24 weeks of life.|Clopper-Pearson Confidence Interval (CI)|43.0|||||TWO_SIDED|90.0|28.6|58.1||||||||58.1|28.6|
72492501|NCT01780831|144513570|OTHER|Point and 90% CI estimates of percentage Cohort 1 infants who died or had SADR of Grade 3 or 4 through 6 weeks of life.|Clopper-Pearson Confidence Interval (CI|6.0|||||TWO_SIDED|90.0|0.3|26.4||||||||26.4|0.3|
72492502|NCT01780831|144513570|OTHER|Point and 90% CI estimates of percentage Cohort 2 infants who died or had SADR of Grade 3 or 4 through 6 weeks of life.|Clopper-Pearson Confidence Interval (CI)|0.0|||||TWO_SIDED||||||||CI is not provided since the estimation parameter is 0.|||||
72492503|NCT01780831|144513571|OTHER|Point and 90% CI estimates of percentage Cohort 1 infants who died or had SADR of Grade 3 or 4 through 24 weeks of life.|Clopper-Pearson Confidence Interval (CI)|6.0|||||TWO_SIDED|90.0|0.3|26.4||||||||26.4|0.3|
72492504|NCT01780831|144513571|OTHER|Point and 90% CI estimates of percentage Cohort 2 infants who died or had SADR of Grade 3 or 4 through 24 weeks of life.|Clopper-Pearson Confidence Interval (CI)|0.0|||||TWO_SIDED||||||||CI is not provided since the estimation parameter is 0.|||||
72517895|NCT05014542|144565683|SUPERIORITY||Mean Difference (Final Values)|-42.8|||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||mean (WOMAC total of group A in Week 15) - mean (WOMAC total of group C in Week 15)|WOMAC total analysis between groups at Week 15. The Shapiro-Wilk test (S-W) was used for testing the normality of the data distribution. The comparability of groups regarding specified variables to accept or reject the null hypothesis of groups' similarity was tested with the Mann-Whitney U test, with 95% power and a significance level α = 0,05. Interquartile range (IQR) and standard deviation (SD) were calculated to present the statistical dispersion of sample data at specified assessments.||||<0.001
72517896|NCT05014542|144565684|SUPERIORITY||Mean Difference (Final Values)|-8.9|||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||mean (WOMAC pain of group A at Week 15) - mean (WOMAC pain of group C at Week 15)|WOMAC pain analysis between groups at Week 15. The Shapiro-Wilk test (S-W) was used for testing the normality of the data distribution. The comparability of groups regarding specified variables to accept or reject the null hypothesis of groups' similarity was tested with the Mann-Whitney U test, with 95% power and a significance level α = 0,05. Interquartile range (IQR) and standard deviation (SD) were calculated to present the statistical dispersion of sample data at assessments.||||<.001
72517897|NCT05014542|144565685|SUPERIORITY||Mean Difference (Final Values)|-3.9|||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||mean (WOMAC stiffness of group A at Week 15) - mean (WOMAC stiffness of group C at Week 15)|WOMAC stiffness between groups at Week 15. The Shapiro-Wilk test (S-W) was used to test the data distribution's normality. The comparability of groups regarding specified variables to accept or reject the null hypothesis of groups' similarity was tested with the Mann-Whitney U test, with 95% power and a significance level α = 0,05. Interquartile range (IQR) and standard deviation (SD) were calculated to present the statistical dispersion of sample data at specified assessments.||||<0.001
72569509|NCT02856880|144669961|SUPERIORITY_OR_OTHER||Least square (LS) mean difference|40.18|||<|0.0001|TWO_SIDED|95.0|32.37|47.99||Obtained from ANCOVA including period and treatment as fixed effects, participant as a random effect and participant-level pre-treatment values and period minus participant-level pre-treatment values as covariates in the model.|ANCOVA||Difference is first named treatment minus second named treatment such that a positive difference indicates a greater inhibition of plaque Glycolysis for the first named treatment.|||47.99|32.37|<0.0001
72492505|NCT01780831|144513572|OTHER|||||||0.298|||||||Wilcoxon (Mann-Whitney)|||||||0.298
72492506|NCT01780831|144513573|OTHER|||||||0.37|||||||Wilcoxon (Mann-Whitney)|||||||0.37
72492507|NCT01780831|144513574|OTHER|||||||0.98|||||||Wilcoxon (Mann-Whitney)|||||||0.98
72492508|NCT00267748|144513584|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.089||||0.86|TWO_SIDED|95.0|0.423|2.803|||Log Rank|||For High risk factor, the hazard ratio of TTP was estimated using stratified Cox Proportional Hazard model with the MSKCC prognostic factors (low, intermediate, high), used in the randomization, as a stratum and median TTP was estimated using Kaplan-Meier method. Log rank method was used to calculate p value.||2.803|0.423|0.860
72492509|NCT00267748|144513584|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.902||||0.583|TWO_SIDED|95.0|0.623|1.306|||Log Rank|||For intermediate risk factor, the hazard ratio of TTP was estimated using stratified Cox Proportional Hazard model with the MSKCC prognostic factors (low, intermediate, high), used in the randomization, as a stratum and median TTP was estimated using Kaplan-Meier method. Log rank method was used to calculate p value.||1.306|0.623|0.583
72492510|NCT00267748|144513584|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.556||||0.075|TWO_SIDED|95.0|0.288|1.074|||Log Rank|||For low risk factor, the hazard ratio of TTP was estimated using stratified Cox Proportional Hazard model with the MSKCC prognostic factors (low, intermediate, high), used in the randomization, as a stratum and median TTP was estimated using Kaplan-Meier method. Log rank method was used to calculate p value.||1.074|0.288|0.075
72492511|NCT00267748|144513584|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.827||||0.22|TWO_SIDED|95.0|0.609|1.124|||Log Rank|||For overall stratified analysis, the hazard ratio of TTP was estimated using stratified Cox Proportional Hazard model with the MSKCC prognostic factors (low, intermediate, high), used in the randomization, as a stratum and median TTP was estimated using Kaplan-Meier method. Log rank method was used to calculate p value.||1.124|0.609|0.220
72492512|NCT00267748|144513584|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.773||||0.09|TWO_SIDED|95.0|0.572|1.044|||Log Rank|||For overall unstratified analysis, the hazard ratio of TTP was estimated using stratified Cox Proportional Hazard model. Two-sided unstratified Log rank method was used to calculate p value.||1.044|0.572|0.090
72492513|NCT00267748|144513585|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.11||||0.444|TWO_SIDED|95.0|-6.4|14.6|||Chi-squared|||Response rate was estimated for each treatment group, 95% Confidence Interval (CI) on the difference in response rate between the 2 treatments was computed. P-value was calculated from a Pearson chi-square test.||14.6|-6.4|0.444
72492514|NCT00267748|144513587|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.071||||0.866|TWO_SIDED|95.0|0.481|2.387|||Log Rank|||For high risk factor, the hazard ratio of OS was estimated using stratified Cox Proportional Hazard model with the MSKCC prognostic factors (low, intermediate, high), used in the randomization, as a stratum and median OS was estimated using Kaplan-Meier method. Log rank method was used to calculate p value.||2.387|0.481|0.866
72569510|NCT02856880|144669962|SUPERIORITY_OR_OTHER||LS mean difference|26.41|||<|0.0001|TWO_SIDED|95.0|18.94|33.88||Obtained from ANCOVA including period and treatment as fixed effects, participant as a random effect and participant-level pre-treatment values and period minus participant-level pre-treatment values as covariates in the model.|ANCOVA||Difference is first named treatment minus second named treatment such that a positive difference indicates a greater inhibition of plaque glycolysis for the first named treatment.|||33.88|18.94|<0.0001
72405265|NCT01920932|144318308|SUPERIORITY|||||||0.032|||||||t-test, 2 sided|||PedsQL v.4.0 Total Score-T2, completion of 2 cycles of chemotherapy (approximately 2 months)||||0.032
72492515|NCT00267748|144513587|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.169||||0.439|TWO_SIDED|95.0|0.785|1.741|||Log Rank|||For intermediate risk factor,the hazard ratio of OS was estimated using stratified Cox Proportional Hazard model with the MSKCC prognostic factors (low, intermediate, high), used in the randomization, as a stratum and median OS was estimated using Kaplan-Meier method. Log rank method was used to calculate p value.||1.741|0.785|0.439
72492516|NCT00267748|144513587|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.238||||0.614|TWO_SIDED|95.0|0.538|2.851|||Log Rank|||For low risk factor, the hazard ratio of OS was estimated using stratified Cox Proportional Hazard model with the MSKCC prognostic factors (low, intermediate, high), used in the randomization, as a stratum and median OS was estimated using Kaplan-Meier method. Log rank method was used to calculate p value.||2.851|0.538|0.614
72492517|NCT00267748|144513587|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.162||||0.365|TWO_SIDED|95.0|0.838|1.612|||Log Rank|||For overall stratified analysis, the hazard ratio of OS was estimated using stratified Cox Proportional Hazard model with the MSKCC prognostic factors (low, intermediate, high), used in the randomization, as a stratum and median OS was estimated using Kaplan-Meier method. Log rank method was used to calculate p value.||1.612|0.838|0.365
72492518|NCT00267748|144513588|SUPERIORITY_OR_OTHER|||||||0.6737|TWO_SIDED||||||t-test, 2 sided|||P value was calculated using sample t-test.||||0.6737
72492519|NCT00267748|144513589|SUPERIORITY_OR_OTHER|||||||0.1967|TWO_SIDED||||||t-test, 2 sided|||P value was calculated using sample t-test.||||0.1967
72492520|NCT01294800|144513590|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-0.7||||0.0564|TWO_SIDED|95.0|-1.37|0.02|||Constrained longitudinal data analysis|||||0.02|-1.37|0.0564
72492521|NCT01294800|144513590|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-0.5||||0.1844|TWO_SIDED|95.0|-1.16|0.22|||Constrained longitudinal data analysis|||||0.22|-1.16|0.1844
72492522|NCT01294800|144513590|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-0.3||||0.3386|TWO_SIDED|95.0|-1.04|0.36|||Constrained longitudinal data analysis|||||0.36|-1.04|0.3386
72492523|NCT01294800|144513591|SUPERIORITY_OR_OTHER||Difference in proportions of responders|5.7||||0.404|TWO_SIDED|95.0|-7.75|19.0|||A generalized linear mixed model|||||19.00|-7.75|0.404
72405266|NCT01920932|144318308|SUPERIORITY|||||||0.497|||||||Wilcoxon (Mann-Whitney)|||PedsQL v.4.0 Total Score-T3, completion of 4 cycles of chemotherapy (approximately 4 months)||||0.497
72492524|NCT01294800|144513591|SUPERIORITY_OR_OTHER||Difference in proportions of responders|5.7||||0.39|TWO_SIDED|95.0|-7.73|18.81|||A generalized linear mixed model|||||18.81|-7.73|0.390
72492525|NCT01294800|144513591|SUPERIORITY_OR_OTHER||Difference in proportions of responders|-4.9||||0.508|TWO_SIDED|95.0|-17.78|7.97|||A generalized linear mixed model|||||7.97|-17.78|0.508
72492526|NCT01294800|144513592|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|0.7||||0.0509|TWO_SIDED|95.0|0.0|1.43|||Constrained longitudinal data analysis|||||1.43|-0.00|0.0509
72492527|NCT01294800|144513592|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|0.5||||0.1847|TWO_SIDED|95.0|-0.23|1.19|||Constrained longitudinal data analysis|||||1.19|-0.23|0.1847
72492528|NCT01294800|144513592|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|0.5||||0.2021|TWO_SIDED|95.0|-0.25|1.19|||Constrained longitudinal data analysis|||||1.19|-0.25|0.2021
72492529|NCT05098041|144513595|OTHER|Linear mixed-effects model was used for analysis. The model included treatment as a fixed effect and participant as a random effect. The point estimates and 90 percent (%) confidence intervals (CIs) for the Geometric Mean Ratio (GMR) of Cmax for Soticlestat and Rifampin versus Soticlestat alone were calculated using the exponentiation of the point estimates of the difference between treatment regimen and the corresponding 90% CIs from the analyses on the natural-log (ln)-transformed Cmax.|Geometric Mean Ratio (%)|13.15|||||TWO_SIDED|90.0|9.73|17.79|||||GMR (%) was calculated as 100\*(Soticlestat + Rifampin/Soticlestat Alone).|||17.79|9.73|
72492530|NCT05098041|144513596|OTHER|Linear mixed-effects model was used for analysis. The model included treatment as a fixed effect and participant as a random effect. The point estimates and 90% CIs for the GMR of AUC∞ for Soticlestat and Rifampin versus Soticlestat alone were calculated using the exponentiation of the point estimates of the difference between treatment regimen and the corresponding 90% CIs from the analyses on the ln-transformed AUC∞.|Geometric Mean Ratio (%)|16.42|||||TWO_SIDED|90.0|12.53|21.5|||||GMR (%) was calculated as 100\*(Soticlestat + Rifampin/Soticlestat Alone).|||21.50|12.53|
72492531|NCT05098041|144513597|OTHER|Linear mixed-effects model was used for analysis. The model included treatment as a fixed effect and participant as a random effect. The point estimates and 90% CIs for the GMR of AUClast for Soticlestat and Rifampin versus Soticlestat alone were calculated using the exponentiation of the point estimates of the difference between treatment regimen and the corresponding 90% CIs from the analyses on the ln-transformed AUClast.|Geometric Mean Ratio (%)|14.92|||||TWO_SIDED|90.0|11.94|18.64|||||GMR (%) was calculated as 100\*(Soticlestat + Rifampin/Soticlestat Alone).|||18.64|11.94|
72492532|NCT05098041|144513598|OTHER||Median Difference (Final Values)|-0.117|||=|0.0791|TWO_SIDED|90.0|-0.202|0.0|||Wilcoxon Signed-Rank Test||Difference was calculated as (Soticlestat + Rifampin) - Soticlestat Alone. The difference of medians (treatment effect) and the corresponding 90% CI was estimated using the Hodges-Lehmann method and Walsh Averages.|||0.000|-0.202|=0.07910
72492533|NCT00797732|144513603|SUPERIORITY|||||||0.17|||||||Wilcoxon (Mann-Whitney)|||||||.17
72405267|NCT01920932|144318308|SUPERIORITY|||||||0.399|||||||Wilcoxon (Mann-Whitney)|||PedsQL v.4.0 Total Score-T4, completion of radiation (approximately 8 months)||||0.399
72405268|NCT01920932|144318308|SUPERIORITY|||||||0.451|||||||Wilcoxon (Mann-Whitney)|||PedsQL v.4.0 Physical Functioning-T1, At Diagnosis (baseline)||||0.451
72492534|NCT02275338|144513614|OTHER|||||||0.0055||||||The expected proportion of responders using Lanreotide was 50%, 1 sided test, 2.5% significance level alpha and power of 80% using Z-test for binomial proportion.|Binomial test|||One sided binomial test to compare percentage of responding subjects to theoretical proportion of 30%.||||0.0055
72569511|NCT02856880|144669962|SUPERIORITY_OR_OTHER||LS mean difference|-2.91||||0.4823|TWO_SIDED|95.0|-11.18|5.37||Obtained from ANCOVA including period and treatment as fixed effects, participant as a random effect and participant-level pre-treatment values and period minus participant-level pre-treatment values as covariates in the model.|ANCOVA||Difference is first named treatment minus second named treatment such that a positive difference indicates a greater inhibition of glycolysis for the first named treatment.|||5.37|-11.18|0.4823
72569512|NCT02856880|144669962|SUPERIORITY_OR_OTHER||LS mean difference|10.86||||0.0072|TWO_SIDED|95.0|3.13|18.59||Obtained from ANCOVA including period and treatment as fixed effects, participant as a random effect and participant-level pre-treatment values and period minus participant-level pre-treatment values as covariates in the model.|ANCOVA||Difference is first named treatment minus second named treatment such that a positive difference indicates a greater inhibition of plaque glycolysis for the first named treatment.|||18.59|3.13|0.0072
72569513|NCT02856880|144669962|SUPERIORITY_OR_OTHER||LS mean difference|13.77||||0.0009|TWO_SIDED|95.0|6.01|21.53||Obtained from ANCOVA including period and treatment as fixed effects, participant as a random effect and participant-level pre-treatment values and period minus participant-level pre-treatment values as covariates in the model.|ANCOVA||Difference is first named treatment minus second named treatment such that a positive difference indicates a greater inhibition of plaque glycolysis for the first named treatment.|||21.53|6.01|0.0009
72569514|NCT02856880|144669962|SUPERIORITY_OR_OTHER||LS mean difference|8.44||||0.0286|TWO_SIDED|95.0|0.93|15.95||Obtained from ANCOVA including period and treatment as fixed effects, participant as a random effect and participant-level pre-treatment values and period minus participant-level pre-treatment values as covariates in the model.|ANCOVA||Difference is first named treatment minus second named treatment such that a positive difference indicates a greater inhibition of plaque glycolysis for the first named treatment.|||15.95|0.93|0.0286
72492535|NCT00684788|144513690|SUPERIORITY||Odds Ratio (OR)|5.68|||=|0.008|TWO_SIDED|95.0|1.61|20.02|||General Estimating Equation (GEE)|||||20.02|1.61|=0.008
72569515|NCT02856880|144669962|SUPERIORITY_OR_OTHER||LS mean difference|5.32||||0.1573|TWO_SIDED|95.0|-2.15|12.79||Obtained from ANCOVA including period and treatment as fixed effects, participant as a random effect and participant-level pre-treatment values and period minus participant-level pre-treatment values as covariates in the model.|ANCOVA||Difference is first named treatment minus second named treatment such that a positive difference indicates a greater inhibition of plaque glycolysis for the first named treatment.|||12.79|-2.15|0.1573
72492536|NCT00684788|144513691|SUPERIORITY|||||||0.0033|||||||t-test, 2 sided|||||||0.0033
72492537|NCT00684788|144513694|SUPERIORITY||Odds Ratio (OR)|1.05||||0.939|TWO_SIDED|95.0|0.32|3.42|||General Estimating Equation (GEE)|||||3.42|0.32|0.939
72492538|NCT00684788|144513696|SUPERIORITY||Odds Ratio (OR)|1.074||||0.959|TWO_SIDED|95.0|0.071|16.245|||General Estimating Equation (GEE)|||||16.245|0.071|0.959
72492539|NCT00623428|144513697|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.8||||0.4557|TWO_SIDED|95.0|0.45|1.43|||Cochran-Mantel-Haenszel|Stratified by HCV genotype (2 vs 3), region (US vs non-US) and initial Ribavirin dose (800mg vs 1000-1200mg).|"The odds ratio is the ratio of the odds of a response in the 24-week treatment group to the odds of a response in the 48-week treatment group.~(second column)."|In order to detect an improvement in SVR rate across all strata equivalent to an odds ratio of 2 (i.e. an increase in SVR by 15 to 16 percentage points at a power of 80% and a two-sided significance level of 0.05, 160 patients per treatment group (320 patients in total) were required.||1.43|0.45|0.4557
72492540|NCT00623428|144513698|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.59||||0.0788|TWO_SIDED|95.0|0.33|1.06|||Cochran-Mantel-Haenszel|Stratified by HCV genotype (2 vs 3), region (US vs non-US) and initial Ribavirin dose (800mg vs 1000-1200mg).|The odds ratio is the ratio of the odds of a response in the 24-week treatment group to the odds of a response in the 48-week treatment group.|||1.06|0.33|0.0788
72492541|NCT00623428|144513699|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.36||||0.5654|TWO_SIDED|95.0|0.48|3.87|||Cochran-Mantel-Haenszel|Stratified by HCV genotype (2 vs 3), region (US vs non-US) and initial Ribavirin dose (800mg vs 1000-1200mg).|The odds ratio is the ratio of the odds of a response in the 24-week treatment group to the odds of a response in the 48-week treatment group.|||3.87|0.48|0.5654
72492542|NCT00623428|144513701|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.68||||0.1934|TWO_SIDED|95.0|0.38|1.21|||Cochran-Mantel-Haenszel|Stratified by HCV genotype (2 vs 3), region (US vs non-US) and initial Ribavirin dose (800mg vs 1000-1200mg).|The odds ratio is the ratio of the odds of a response in the 24-week treatment group to the odds of a response in the 48-week treatment group.|||1.21|0.38|0.1934
72492543|NCT00623428|144513702|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.68||||0.1934|TWO_SIDED|95.0|0.38|1.21|||Cochran-Mantel-Haenszel|Stratified by HCV genotype (2 vs 3), region (US vs non-US) and initial Ribavirin dose (800mg vs 1000-1200mg).|The odds ratio is the ratio of the odds of a response in the 24-week treatment group to the odds of a response in the 48-week treatment group.|||1.21|0.38|0.1934
72492544|NCT01180660|144513712|SUPERIORITY_OR_OTHER||Median Difference (Net)|19.0||||0.01|TWO_SIDED|95.0|3.0|27.0|||Regression, Linear|||A sample size of 22 subjects per group was estimated to achieve 90% power to detect a 16 point difference in the aggregated Qor-40 score for the two study groups to be compared assuming an overall standard deviation of 16 points similar to what was observed in a previous investigation.||27|3|.01
72492545|NCT05048719|144513758|SUPERIORITY||LS Mean Difference|-0.77|||<|0.001|TWO_SIDED|95.0|-1.13|-0.4|||Mixed Models Analysis|||||-0.40|-1.13|<0.001
72569516|NCT02856880|144669962|SUPERIORITY_OR_OTHER||LS mean difference|-29.32|||<|0.0001|TWO_SIDED|95.0|-37.2|-21.43||Obtained from ANCOVA including period and treatment as fixed effects, participant as a random effect and participant-level pre-treatment values and period minus participant-level pre-treatment values as covariates in the model.|ANCOVA||Difference is first named treatment minus second named treatment such that a positive difference indicates a greater inhibition of plaque glycolysis for the first named treatment.|||-21.43|-37.20|<0.0001
72624817|NCT02085720|144778990|NON_INFERIORITY_OR_EQUIVALENCE|Data were given as means and standard deviations, unless otherwise stated. AHI was categorized as ≥ 5, ≥ 10, ≥ 15 and ≥ 20. The frequency distribution of responses on the SHQ and their relationship to AHI was assessed with the chi-squared analysis. The association of variables such as age, BMI, neck circumference, ESS and sleep health questionnaire responses versus AHI was evaluated using one-way analysis of variance and Pearson Correlation Analysis.|||||<|0.05|||||||ANOVA|||||||<0.05
72492546|NCT05048719|144513758|SUPERIORITY||LS Mean Difference|-1.49|||<|0.001|TWO_SIDED|95.0|-1.85|-1.12|||Mixed Models Analysis|||||-1.12|-1.85|<0.001
72405269|NCT01920932|144318308|SUPERIORITY|||||||0.198|||||||Wilcoxon (Mann-Whitney)|||PedsQL v.4.0 Physical Functioning-T2, completion of 2 cycles of chemotherapy (approximately 2 months)||||0.198
72405270|NCT01920932|144318308|SUPERIORITY|||||||0.967|||||||Wilcoxon (Mann-Whitney)|||PedsQL v.4.0 Physical Functioning-T3, completion of 4 cycles of chemotherapy (approximately 4 months)||||0.967
72405271|NCT01920932|144318308|SUPERIORITY|||||||0.647|||||||Wilcoxon (Mann-Whitney)|||PedsQL v.4.0 Physical Functioning-T4, completion of radiation (approximately 8 months)||||0.647
72405272|NCT01920932|144318308|SUPERIORITY|||||||0.145|||||||Wilcoxon (Mann-Whitney)|||PedsQL v.4.0 Emotional Functioning-T1, At Diagnosis (baseline)||||0.145
72405273|NCT01920932|144318308|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||PedsQL v.4.0 Emotional Functioning-T2, completion of 2 cycles of chemotherapy (approximately 2 months)||||<.001
72492547|NCT05048719|144513758|SUPERIORITY||LS Mean Difference|-1.36|||<|0.001|TWO_SIDED|95.0|-1.75|-0.98|||Mixed Models Analysis|||||-0.98|-1.75|<0.001
72492548|NCT05048719|144513758|SUPERIORITY||LS Mean Difference|-1.6|||<|0.001|TWO_SIDED|95.0|-1.96|-1.25|||Mixed Models Analysis|||||-1.25|-1.96|<0.001
72569517|NCT02856880|144669962|SUPERIORITY_OR_OTHER||LS mean difference|31.74|||<|0.0001|TWO_SIDED|95.0|24.18|39.3||Obtained from ANCOVA including period and treatment as fixed effects, participant as a random effect and participant-level pre-treatment values and period minus participant-level pre-treatment values as covariates in the model.|ANCOVA||Difference is first named treatment minus second named treatment such that a positive difference indicates a greater inhibition of plaque glycolysis for the first named treatment.|||39.30|24.18|<0.0001
72492549|NCT05048719|144513758|SUPERIORITY||LS Mean Difference|-1.67|||<|0.001|TWO_SIDED|95.0|-2.02|-1.32|||Mixed Models Analysis|||||-1.32|-2.02|<0.001
72492550|NCT05048719|144513759|SUPERIORITY||LS Mean Difference|-0.09||||0.626|TWO_SIDED|95.0|-0.47|0.28|||Mixed Models Analysis|||||0.28|-0.47|0.626
72624818|NCT04262479|144779032|OTHER||||||||||||||||||Counting number of events.|||
72492551|NCT05048719|144513759|SUPERIORITY||LS Mean Difference|-0.81|||<|0.001|TWO_SIDED|95.0|-1.18|-0.44|||Mixed Models Analysis|||||-0.44|-1.18|<0.001
72492552|NCT05048719|144513759|SUPERIORITY||LS Mean Difference|-0.69|||<|0.001|TWO_SIDED|95.0|-1.08|-0.3|||Mixed Models Analysis|||||-0.30|-1.08|<0.001
72492553|NCT05048719|144513759|SUPERIORITY||LS Mean Difference|-0.93|||<|0.001|TWO_SIDED|95.0|-1.29|-0.57|||Mixed Models Analysis|||||-0.57|-1.29|<0.001
72569518|NCT02856880|144669962|SUPERIORITY_OR_OTHER||LS mean difference|2.42||||0.5174|TWO_SIDED|95.0|-5.08|9.92||Obtained from ANCOVA including period and treatment as fixed effects, participant as a random effect and participant-level pre-treatment values and period minus participant-level pre-treatment values as covariates in the model.|ANCOVA||Difference is first named treatment minus second named treatment such that a positive difference indicates a greater inhibition of plaque glycolysis for the first named treatment.|||9.92|-5.08|0.5174
72405274|NCT01920932|144318308|SUPERIORITY|||||||0.073|||||||Wilcoxon (Mann-Whitney)|||PedsQL v.4.0 Emotional Functioning-T3, completion of 4 cycles of chemotherapy (approximately 4 months)||||0.073
72405275|NCT01920932|144318308|SUPERIORITY|||||||0.156|||||||Wilcoxon (Mann-Whitney)|||PedsQL v.4.0 Emotional Functioning-T4, completion of radiation (approximately 8 months)||||0.156
72405276|NCT01920932|144318308|SUPERIORITY|||||||0.844|||||||Wilcoxon (Mann-Whitney)|||PedsQL v.4.0 Social Functioning-T1, At Diagnosis (baseline)||||0.844
72405277|NCT01920932|144318308|SUPERIORITY|||||||0.206|||||||Wilcoxon (Mann-Whitney)|||PedsQL v.4.0 Social Functioning-T2, completion of 2 cycles of chemotherapy (approximately 2 months)||||0.206
72405278|NCT01920932|144318308|SUPERIORITY|||||||0.491|||||||Wilcoxon (Mann-Whitney)|||PedsQL v.4.0 Social Functioning-T3, completion of 4 cycles of chemotherapy (approximately 4 months)||||0.491
72405279|NCT01920932|144318308|SUPERIORITY|||||||0.906|||||||Wilcoxon (Mann-Whitney)|||PedsQL v.4.0 Social Functioning-T4, completion of radiation (approximately 8 months)||||0.906
72405280|NCT01920932|144318308|SUPERIORITY|||||||0.58|||||||Wilcoxon (Mann-Whitney)|||PedsQL v.4.0 School Functioning-T1, At Diagnosis (baseline)||||0.580
72405281|NCT01920932|144318308|SUPERIORITY|||||||0.012|||||||Wilcoxon (Mann-Whitney)|||PedsQL v.4.0 School Functioning-T2, completion of 2 cycles of chemotherapy (approximately 2 months)||||0.012
72405282|NCT01920932|144318308|SUPERIORITY|||||||0.01|||||||Wilcoxon (Mann-Whitney)|||PedsQL v.4.0 School Functioning-T3, completion of 4 cycles of chemotherapy (approximately 4 months)||||0.010
72405283|NCT01920932|144318308|SUPERIORITY|||||||0.005|||||||Wilcoxon (Mann-Whitney)|||PedsQL v.4.0 School Functioning-T4, completion of radiation (approximately 8 months)||||0.005
72492554|NCT05048719|144513759|SUPERIORITY||LS Mean Difference|-1.0|||<|0.001|TWO_SIDED|95.0|-1.36|-0.64|||Mixed Models Analysis|||||-0.64|-1.36|<0.001
72492555|NCT05048719|144513760|OTHER||Odds Ratio (OR)|6.77|||<|0.001|TWO_SIDED|95.0|2.21|20.75|||Regression, Logistic|||||20.75|2.21|<0.001
72492556|NCT05048719|144513760|OTHER||Odds Ratio (OR)|34.09|||<|0.001|TWO_SIDED|95.0|9.92|117.16|||Regression, Logistic|||||117.16|9.92|<0.001
72492557|NCT05048719|144513760|OTHER||Odds Ratio (OR)|48.33|||<|0.001|TWO_SIDED|95.0|11.9|196.24|||Regression, Logistic|||||196.24|11.90|<0.001
72492558|NCT05048719|144513760|OTHER||Odds Ratio (OR)|45.72|||<|0.001|TWO_SIDED|95.0|13.61|153.64|||Regression, Logistic|||||153.64|13.61|<0.001
72492559|NCT05048719|144513760|OTHER||Odds Ratio (OR)|77.23|||<|0.001|TWO_SIDED|95.0|20.26|294.48|||Regression, Logistic|||||294.48|20.26|<0.001
72492560|NCT05048719|144513760|OTHER||Odds Ratio (OR)|1.22||||0.678|TWO_SIDED|95.0|0.48|3.13|||Regression, Logistic|||||3.13|0.48|0.678
72492561|NCT05048719|144513760|OTHER||Odds Ratio (OR)|6.15|||<|0.001|TWO_SIDED|95.0|2.19|17.24|||Regression, Logistic|||||17.24|2.19|<0.001
72492562|NCT05048719|144513760|OTHER||Odds Ratio (OR)|8.71|||<|0.001|TWO_SIDED|95.0|2.55|29.79|||Regression, Logistic|||||29.79|2.55|<0.001
72492563|NCT05048719|144513760|OTHER||Odds Ratio (OR)|8.24|||<|0.001|TWO_SIDED|95.0|3.05|22.3|||Regression, Logistic|||||22.30|3.05|<0.001
72492564|NCT05048719|144513760|OTHER||Odds Ratio (OR)|13.93|||<|0.001|TWO_SIDED|95.0|4.51|43.01|||Regression, Logistic|||||43.01|4.51|<0.001
72492565|NCT05048719|144513761|OTHER||Odds Ratio (OR)|8.19|||<|0.001|TWO_SIDED|95.0|2.93|22.9|||Regression, Logistic|||||22.90|2.93|<0.001
72492566|NCT05048719|144513761|OTHER||Odds Ratio (OR)|25.02|||<|0.001|TWO_SIDED|95.0|7.57|82.69|||Regression, Logistic|||||82.69|7.57|<0.001
72624819|NCT04262479|144779033|OTHER||||||||||||||||||Counting number of events|||
72624820|NCT04262479|144779034|OTHER||||||<|0.001||||||P-value threshold for significance: \<0.05|Wilcoxon signed rank test|||||||<0.001
72405284|NCT00071812|144318313|SUPERIORITY_OR_OTHER||percent difference from placebo|18.8||||0.0097|TWO_SIDED|95.0|4.8|32.8||P-value was not adjusted for multiple testing.|Likelihood ratio chi-squared|||Patients who required rescue RA medications were declared nonresponders, as were patients who dropped out or were missing Week 24 data.||32.8|4.8|0.0097
72405285|NCT00071812|144318313|SUPERIORITY_OR_OTHER||percent difference from placebo|9.4||||0.1677|TWO_SIDED|95.0|-3.9|22.7||P-value was not adjusted for multiple testing.|Likelihood ratio chi-squared|||Patients who required rescue RA medications were declared nonresponders, as were patients who dropped out or were missing Week 24 data.||22.7|-3.9|0.1677
72492567|NCT05048719|144513761|OTHER||Odds Ratio (OR)|62.31|||<|0.001|TWO_SIDED|95.0|12.26|316.63|||Regression, Logistic|||||316.63|12.26|<0.001
72492568|NCT05048719|144513761|OTHER||Odds Ratio (OR)|67.57|||<|0.001|TWO_SIDED|95.0|17.56|259.97|||Regression, Logistic|||||259.97|17.56|<0.001
72492569|NCT05048719|144513761|OTHER||Odds Ratio (OR)|129.55|||<|0.001|TWO_SIDED|95.0|26.72|628.09|||Regression, Logistic|||||628.09|26.72|<0.001
72492570|NCT05048719|144513761|OTHER||Odds Ratio (OR)|1.13||||0.802|TWO_SIDED|95.0|0.43|2.96|||Regression, Logistic|||||2.96|0.43|0.802
72492571|NCT05048719|144513761|OTHER||Odds Ratio (OR)|3.46||||0.026|TWO_SIDED|95.0|1.16|10.31|||Regression, Logistic|||||10.31|1.16|0.026
72492572|NCT05048719|144513761|OTHER||Odds Ratio (OR)|8.61||||0.006|TWO_SIDED|95.0|1.83|40.51|||Regression, Logistic|||||40.51|1.83|0.006
72492573|NCT05048719|144513761|OTHER||Odds Ratio (OR)|9.34|||<|0.001|TWO_SIDED|95.0|2.67|32.71|||Regression, Logistic|||||32.71|2.67|<0.001
72492574|NCT05048719|144513761|OTHER||Odds Ratio (OR)|17.9|||<|0.001|TWO_SIDED|95.0|4.02|79.7|||Regression, Logistic|||||79.70|4.02|<0.001
72624821|NCT04262479|144779035|OTHER||||||<|0.05||||||P-value threshold for significance: \<0.05|Wilcoxon signed rank test|||||||<0.05
72492575|NCT05048719|144513762|OTHER||LS Mean Difference|-21.5|||<|0.001|TWO_SIDED|95.0|-32.7|-10.3|||Mixed Models Analysis|||||-10.3|-32.7|<0.001
72624822|NCT04262479|144779036|OTHER||||||<|0.61||||||P-value threshold for significance: \<0.05|Wilcoxon signed rank test|||||||<0.61
72624823|NCT04262479|144779037|OTHER||||||<|0.3||||||P-value threshold for significance: \<0.05|Wilcoxon signed rank test|||||||<0.30
72624824|NCT04262479|144779038|OTHER||||||<|0.002||||||P-value threshold for significance: \<0.05|Wilcoxon signed rank test|||||||<0.002
72405286|NCT00071812|144318313|SUPERIORITY_OR_OTHER||percent difference from placebo|12.2||||0.0796|TWO_SIDED|95.0|-1.3|25.8||P-value was not adjusted for multiple testing.|Likelihood ratio chi-squared|||Patients who required rescue RA medications were declared nonresponders, as were patients who dropped out or were missing Week 24 data.||25.8|-1.3|0.0796
72492576|NCT05048719|144513762|OTHER||LS Mean Difference|-42.5|||<|0.001|TWO_SIDED|95.0|-53.4|-31.7|||Mixed Models Analysis|||||-31.7|-53.4|<0.001
72492577|NCT05048719|144513762|OTHER||LS Mean Difference|-41.0|||<|0.001|TWO_SIDED|95.0|-52.7|-29.3|||Mixed Models Analysis|||||-29.3|-52.7|<0.001
72492578|NCT05048719|144513762|OTHER||LS Mean Difference|-42.7|||<|0.001|TWO_SIDED|95.0|-53.5|-32.0|||Mixed Models Analysis|||||-32.0|-53.5|<0.001
72492579|NCT05048719|144513762|OTHER||LS Mean Difference|-44.7|||<|0.001|TWO_SIDED|95.0|-55.3|-34.2|||Mixed Models Analysis|||||-34.2|-55.3|<0.001
72492580|NCT05048719|144513762|OTHER||LS Mean Difference|0.6|||<|0.001|TWO_SIDED|95.0|-10.6|11.8|||Mixed Models Analysis|||||11.8|-10.6|<0.001
72492581|NCT05048719|144513762|OTHER||LS Mean Difference|-20.5|||<|0.001|TWO_SIDED|95.0|-31.4|-9.5|||Mixed Models Analysis|||||-9.5|-31.4|<0.001
72492582|NCT05048719|144513762|OTHER||LS Mean Difference|-19.0||||0.002|TWO_SIDED|95.0|-30.7|-7.2|||Mixed Models Analysis|||||-7.2|-30.7|0.002
72492583|NCT05048719|144513762|OTHER||LS Mean Difference|-20.7|||<|0.001|TWO_SIDED|95.0|-31.4|-9.9|||Mixed Models Analysis|||||-9.9|-31.4|<0.001
72492584|NCT05048719|144513762|OTHER||LS Mean Difference|-22.7|||<|0.001|TWO_SIDED|95.0|-33.2|-12.1|||Mixed Models Analysis|||||-12.1|-33.2|<0.001
72492585|NCT05048719|144513763|OTHER||LS Mean Difference|-1.6||||0.153|TWO_SIDED|95.0|-3.7|0.6|||Mixed Models Analysis|||||0.6|-3.7|0.153
72492586|NCT05048719|144513763|OTHER||LS Mean Difference|-4.3|||<|0.001|TWO_SIDED|95.0|-6.4|-2.2|||Mixed Models Analysis|||||-2.2|-6.4|<0.001
72492587|NCT05048719|144513763|OTHER||LS Mean Difference|-7.6|||<|0.001|TWO_SIDED|95.0|-9.8|-5.3|||Mixed Models Analysis|||||-5.3|-9.8|<0.001
72492588|NCT05048719|144513763|OTHER||LS Mean Difference|-7.4|||<|0.001|TWO_SIDED|95.0|-9.4|-5.3|||Mixed Models Analysis|||||-5.3|-9.4|<0.001
72492589|NCT05048719|144513763|OTHER||LS Mean Difference|-7.9|||<|0.001|TWO_SIDED|95.0|-9.9|-5.9|||Mixed Models Analysis|||||-5.9|-9.9|<0.001
72492590|NCT05048719|144513763|OTHER||LS Mean Difference|0.1||||0.914|TWO_SIDED|95.0|-2.0|2.3|||Mixed Models Analysis|||||2.3|-2.0|0.914
72492591|NCT05048719|144513763|OTHER||LS Mean Difference|-2.6||||0.015|TWO_SIDED|95.0|-4.7|-0.5|||Mixed Models Analysis|||||-0.5|-4.7|0.015
72492592|NCT05048719|144513763|OTHER||LS Mean Difference|-5.9|||<|0.001|TWO_SIDED|95.0|-8.1|-3.6|||Mixed Models Analysis|||||-3.6|-8.1|<0.001
72492593|NCT05048719|144513763|OTHER||LS Mean Difference|-5.7|||<|0.001|TWO_SIDED|95.0|-7.8|-3.6|||Mixed Models Analysis|||||-3.6|-7.8|<0.001
72492594|NCT05048719|144513763|OTHER||LS Mean Difference|-6.2|||<|0.001|TWO_SIDED|95.0|-8.3|-4.2|||Mixed Models Analysis|||||-4.2|-8.3|<0.001
72492595|NCT02229552|144513781|OTHER|Repeated measures analysis of variance with zbmi for each year as the repeated dependent measure.|Mean Difference (Final Values)|3.0||||0.051|TWO_SIDED||||||ANOVA|||||||0.051
72492596|NCT04872101|144513782|SUPERIORITY||Risk Difference (RD)|22.2|||<|0.001|TWO_SIDED|95.0|15.8|28.5||5% significance level (two-sided).|Cochran-Mantel-Haenszel|Stratified by region and baseline IGA-CHE score.|Mantel-Haenszel risk difference, stratified by region and baseline IGA-CHE score.|Based on the primary analysis of the primary estimand 'composite'. Subjects with missing data, subjects who received rescue treatment, or subjects who permanently discontinued IMP were considered non-responders.||28.5|15.8|<0.001
72624825|NCT04262479|144779039|OTHER||||||<|0.72||||||P-value threshold for significance: \<0.05|Wilcoxon signed rank test|||||||<0.72
72624826|NCT04262479|144779040|OTHER||||||<|0.03||||||P-value threshold for significance: \<0.05|Wilcoxon signed rank test|||||||<0.03
72624827|NCT04262479|144779041|OTHER||||||<|0.044||||||P-value threshold for significance: \<0.05|Wilcoxon signed rank test|||||||<0.044
72569519|NCT02856880|144669963|SUPERIORITY_OR_OTHER||LS mean difference|-233.22|||<|0.0001|TWO_SIDED|95.0|-332.88|-133.55||Obtained from ANCOVA including period and treatment as fixed effects, participant as a random effect and participant-level pre-treatment values and period minus participant-level pre-treatment values as covariates in the model.|ANCOVA||Difference is first named treatment minus second named treatment such that a negative difference indicates a greater inhibition of plaque regrowth for the first named treatment.|||-133.55|-332.88|<0.0001
72569520|NCT02856880|144669963|SUPERIORITY_OR_OTHER||LS mean difference|35.53||||0.5018|TWO_SIDED|95.0|-69.9|140.96||Obtained from ANCOVA including period and treatment as fixed effects, participant as a random effect and participant-level pre-treatment values and period minus participant-level pre-treatment values as covariates in the model.|ANCOVA||Difference is first named treatment minus second named treatment such that a negative difference indicates a greater inhibition of plaque regrowth for the first named treatment.|||140.96|-69.90|0.5018
72569521|NCT02856880|144669963|SUPERIORITY_OR_OTHER||LS mean difference|-24.73||||0.6325|TWO_SIDED|95.0|-128.07|78.61||Obtained from ANCOVA including period and treatment as fixed effects, participant as a random effect and participant-level pre-treatment values and period minus participant-level pre-treatment values as covariates in the model.|ANCOVA||Difference is first named treatment minus second named treatment such that a negative difference indicates a greater inhibition of plaque regrowth for the first named treatment.|||78.61|-128.07|0.6325
72569522|NCT02856880|144669963|SUPERIORITY_OR_OTHER||LS mean difference|-60.26||||0.2427|TWO_SIDED|95.0|-162.72|42.21||Obtained from ANCOVA including period and treatment as fixed effects, participant as a random effect and participant-level pre-treatment values and period minus participant-level pre-treatment values as covariates in the model.|ANCOVA||Difference is first named treatment minus second named treatment such that a negative difference indicates a greater inhibition of plaque regrowth for the first named treatment.|||42.21|-162.72|0.2427
72569523|NCT02856880|144669963|SUPERIORITY_OR_OTHER||LS mean difference|1.05||||0.9834|TWO_SIDED|95.0|-100.5|102.61||Obtained from ANCOVA including period and treatment as fixed effects, participant as a random effect and participant-level pre-treatment values and period minus participant-level pre-treatment values as covariates in the model.|ANCOVA||Difference is first named treatment minus second named treatment such that a negative difference indicates a greater inhibition of plaque regrowth for the first named treatment.|||102.61|-100.50|0.9834
72569524|NCT02856880|144669963|SUPERIORITY_OR_OTHER||LS mean difference|-61.31||||0.2226|TWO_SIDED|95.0|-161.14|38.52||Obtained from ANCOVA including period and treatment as fixed effects, participant as a random effect and participant-level pre-treatment values and period minus participant-level pre-treatment values as covariates in the model.|ANCOVA||Difference is first named treatment minus second named treatment such that a negative difference indicates a greater inhibition of plaque regrowth for the first named treatment.|||38.52|-161.14|0.2226
72569525|NCT02856880|144669963|SUPERIORITY_OR_OTHER||LS mean difference|268.74|||<|0.0001|TWO_SIDED|95.0|165.98|371.51||Obtained from ANCOVA including period and treatment as fixed effects, participant as a random effect and participant-level pre-treatment values and period minus participant-level pre-treatment values as covariates in the model.|ANCOVA||Difference is second named treatment(non-SLS negative control) minus first named treatment (SLS negative control) such that a negative difference indicates a greater inhibition of plaque|||371.51|165.98|<0.0001
72569526|NCT02856880|144669963|SUPERIORITY_OR_OTHER||LS mean difference|-293.47|||<|0.0001|TWO_SIDED|95.0|-396.03|-190.91||Obtained from ANCOVA including period and treatment as fixed effects, participant as a random effect and participant-level pre-treatment values and period minus participant-level pre-treatment values as covariates in the model.|ANCOVA||Difference is first named treatment minus second named treatment such that a negative difference indicates a greater inhibition of plaque regrowth for the first named treatment.|||-190.91|-396.03|<0.0001
72569527|NCT02856880|144669963|SUPERIORITY_OR_OTHER||LS mean difference|-294.53|||<|0.0001|TWO_SIDED|95.0|-395.43|-193.62||Obtained from ANCOVA including period and treatment as fixed effects, participant as a random effect and participant-level pre-treatment values and period minus participant-level pre-treatment values as covariates in the model.|ANCOVA||Difference is first named treatment minus second named treatment such that a negative difference indicates a greater inhibition of plaque regrowth for the first named treatment.|||-193.62|-395.43|<0.0001
72569528|NCT02856880|144669963|SUPERIORITY_OR_OTHER||LS mean difference|-25.78||||0.6086|TWO_SIDED|95.0|-126.53|74.96||Obtained from ANCOVA including period and treatment as fixed effects, participant as a random effect and participant-level pre-treatment values and period minus participant-level pre-treatment values as covariates in the model.|ANCOVA||Difference is first named treatment minus second named treatment such that a negative difference indicates a greater inhibition of plaque regrowth for the first named treatment.|||74.96|-126.53|0.6086
72569529|NCT02856880|144669964|SUPERIORITY_OR_OTHER||LS mean difference|-273.92||||0.6664|TWO_SIDED|95.0|-1550.45|1002.61||Obtained from ANCOVA including period and treatment as fixed effects, participant as a random effect and participant-level pre-treatment values and period minus participant-level pre-treatment values as covariates in the model.|ANCOVA||Difference is first named treatment minus second named treatment such that a negative difference indicates a smaller live:dead stain ratio for the first named treatment.|||1002.61|-1550.45|0.6664
72569530|NCT02856880|144669964|SUPERIORITY_OR_OTHER||LS mean difference|674.06||||0.3249|TWO_SIDED|95.0|-692.21|2040.33||Obtained from ANCOVA including period and treatment as fixed effects, participant as a random effect and participant-level pre-treatment values and period minus participant-level pre-treatment values as covariates in the model.|ANCOVA||Difference is first named treatment minus second named treatment such that a negative difference indicates a smaller live:dead stain ratio for the first named treatment.|||2040.33|-692.21|0.3249
72569531|NCT02856880|144669964|SUPERIORITY_OR_OTHER||LS mean difference|677.09||||0.3544|TWO_SIDED|95.0|-784.16|2138.35||Obtained from ANCOVA including period and treatment as fixed effects, participant as a random effect and participant-level pre-treatment values and period minus participant-level pre-treatment values as covariates in the model.|ANCOVA||Difference is first named treatment minus second named treatment such that a negative difference indicates a smaller live:dead stain ratio for the first named treatment.|||2138.35|-784.16|0.3544
72624828|NCT00937105|144779043|SUPERIORITY_OR_OTHER||Cumulative Probability of no-CIE|92.8|||||TWO_SIDED|95.0|88.6|96.9|||Kaplan-Meier|Cumulative Unadjusted Probability of remaining CIE-free presented for entire cohort (both solution groups) to remain consistent with the primary aim||Cumulative Unadjusted Probability of Remaining Infiltrate Free in entire Cohort||96.9|88.6|
72405287|NCT00071812|144318314|SUPERIORITY_OR_OTHER||percent difference from placebo|5.4||||0.2074|TWO_SIDED|95.0|-3.0|13.7||P-value was not adjusted for multiple testing.|Likelihood ratio chi-squared|||Patients who required rescue RA medications were declared nonresponders, as were patients who dropped out or were missing Week 24 data.||13.7|-3.0|0.2074
72405288|NCT00071812|144318314|SUPERIORITY_OR_OTHER||percent difference from placebo|4.1||||0.3177|TWO_SIDED|95.0|-4.0|12.2||P-value was not adjusted for multiple testing.|Likelihood ratio chi-squared|||Patients who required rescue RA medications were declared nonresponders, as were patients who dropped out or were missing Week 24 data.||12.2|-4.0|0.3177
72405289|NCT00071812|144318314|SUPERIORITY_OR_OTHER||percent difference from placebo|9.7||||0.0418|TWO_SIDED|95.0|0.3|19.2||P-value was not adjusted for multiple testing.|Likelihood ratio chi-squared|||Patients who required rescue RA medications were declared nonresponders, as were patients who dropped out or were missing Week 24 data.||19.2|0.3|0.0418
72405290|NCT00071812|144318315|SUPERIORITY_OR_OTHER||percent difference from placebo|2.7||||0.4299|TWO_SIDED|95.0|-4.0|9.3||P-value was not adjusted for multiple testing.|Likelihood ratio chi-squared|||Patients who required rescue RA medications were declared nonresponders, as were patients who dropped out or were missing Week 24 data.||9.3|-4.0|0.4299
72405291|NCT00071812|144318315|SUPERIORITY_OR_OTHER||percent difference from placebo|-1.5||||0.5393|TWO_SIDED|95.0|-6.3|3.3||P-value was not adjusted for multiple testing.|Likelihood ratio chi-squared|||Patients who required rescue RA medications were declared nonresponders, as were patients who dropped out or were missing Week 24 data.||3.3|-6.3|0.5393
72405292|NCT00071812|144318315|SUPERIORITY_OR_OTHER||percent difference from placebo|-0.1||||0.9769|TWO_SIDED|95.0|-5.6|5.4||P-value was not adjusted for multiple testing.|Likelihood ratio chi-squared|||Patients who required rescue RA medications were declared nonresponders, as were patients who dropped out or were missing Week 24 data.||5.4|-5.6|0.9769
72405293|NCT00071812|144318316|SUPERIORITY_OR_OTHER|||||||0.1752||95.0||||P-value was not adjusted for multiple testing.|Log Rank|||Patients who required rescue RA medications were declared nonresponders, as were patients who dropped out or were missing Week 24 data. Patients who did not have any ACR response were censored at the last visit or exit visit, whichever occurred first. Patients who did not have an ACR response and discontinued from the study prior to study completion were censored at the last date on study.||||0.1752
72405294|NCT00071812|144318316|SUPERIORITY_OR_OTHER|||||||0.344||95.0||||P-value was not adjusted for multiple testing.|Log Rank|||Patients who required rescue RA medications were declared nonresponders, as were patients who dropped out or were missing Week 24 data. Patients who did not have any ACR response were censored at the last visit or exit visit, whichever occurred first. Patients who did not have an ACR response and discontinued from the study prior to study completion were censored at the last date on study.||||0.3440
72405295|NCT00071812|144318316|SUPERIORITY_OR_OTHER|||||||0.4308||95.0||||P-value was not adjusted for multiple testing.|Log Rank|||Patients who required rescue RA medications were declared nonresponders, as were patients who dropped out or were missing Week 24 data. Patients who did not have any ACR response were censored at the last visit or exit visit, whichever occurred first. Patients who did not have an ACR response and discontinued from the study prior to study completion were censored at the last date on study.||||0.4308
72405296|NCT00071812|144318319|SUPERIORITY_OR_OTHER|||||||0.0958||95.0||||P-value was not adjusted for multiple testing.|t-test, 2 sided|||Missing data was handled by using last observation carried forward (LOCF) imputation.||||0.0958
72405297|NCT00071812|144318319|SUPERIORITY_OR_OTHER|||||||0.7864||95.0||||P-value was not adjusted for multiple testing.|t-test, 2 sided|||Missing data was handled by using LOCF imputation.||||0.7864
72577153|NCT00264550|144680885|SUPERIORITY_OR_OTHER|||||||0.059||||||This null hypothesis is tested only if a positive test for null hypothesis Statistical Analysis 1.|Chi-squared|||Null hypothesis: No difference between Group II and Group I with respect of ACR 20 at Wk 14. Superiority of golimumab alone vs MTX alone will be demonstrated if 2-sided test is significant. Sample of 120 patients in each Group I \& II provides \>85% power assuming 35% ACR 20 response in Group I and 55% ACR 20 in Group II.||||0.059
72405298|NCT00071812|144318319|SUPERIORITY_OR_OTHER|||||||0.0051||95.0||||P-value was not adjusted for multiple testing.|t-test, 2 sided|||Missing data was handled by using LOCF imputation.||||0.0051
72405299|NCT00071812|144318320|SUPERIORITY_OR_OTHER|||||||0.096||95.0||||P-value was not adjusted for multiple testing.|Log Rank|||Patients who required rescue RA medications were declared nonresponders, as were patients who dropped out or were missing Week 24 data. Patients who did not have good or moderate improvement in DAS28 were censored at the last visit or exit visit, whichever occurred first. Patients who did not have good or moderate improvement in DAS28 and discontinued from the study prior to study completion were censored at the last date on study.||||0.0960
72405300|NCT00071812|144318320|SUPERIORITY_OR_OTHER|||||||0.2859||95.0||||P-value was not adjusted for multiple testing.|Log Rank|||Patients who required rescue RA medications were declared nonresponders, as were patients who dropped out or were missing Week 24 data. Patients who did not have good or moderate improvement in DAS28 were censored at the last visit or exit visit, whichever occurred first. Patients who did not have good or moderate improvement in DAS28 and discontinued from the study prior to study completion were censored at the last date on study.||||0.2859
72405301|NCT00071812|144318320|SUPERIORITY_OR_OTHER|||||||0.0109||95.0||||P-value was not adjusted for multiple testing.|Log Rank|||Patients who required rescue RA medications were declared nonresponders, as were patients who dropped out or were missing Week 24 data. Patients who did not have good or moderate improvement in DAS28 were censored at the last visit or exit visit, whichever occurred first. Patients who did not have good or moderate improvement in DAS28 and discontinued from the study prior to study completion were censored at the last date on study.||||0.0109
72405302|NCT00071812|144318321|SUPERIORITY_OR_OTHER|||||||0.194||95.0||||P-value was not adjusted for multiple testing.|t-test, 2 sided|||Missing data was handled by using LOCF imputation.||||0.1940
72405303|NCT00071812|144318321|SUPERIORITY_OR_OTHER|||||||0.2561||95.0||||P-value was not adjusted for multiple testing.|t-test, 2 sided|||Missing data was handled by using LOCF imputation.||||0.2561
72577154|NCT00264550|144680886|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||||||<0.001
72577155|NCT00264550|144680886|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||Chi-squared|||||||0.001
72577156|NCT00264550|144680886|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||||||<0.001
72577157|NCT00264550|144680886|SUPERIORITY_OR_OTHER|||||||0.035||95.0|||||Chi-squared|||||||0.035
72405304|NCT00071812|144318321|SUPERIORITY_OR_OTHER|||||||0.8707||95.0||||P-value was not adjusted for multiple testing.|t-test, 2 sided|||Missing data was handled by using LOCF imputation.||||0.8707
72405305|NCT01461096|144318429|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.78||||0.35|TWO_SIDED|95.1|0.47|1.31||P-value was unadjusted for multiple comparisons and a P-value less than 5% was the threshold for statistical significance.|generalized log-rank test (Sun 1996)|The generalized log-rank test (Sun 1996) was performed to evaluate whether participants in the two arms had the same survival rate.|qHPV group represented the numerator for the hazard ratio and Placebo group represented the denominator.|||1.31|0.47|0.350
72405306|NCT01417481|144318463|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||t-test, 1 sided|Due to the cross-over, a paired analysis was done. The hypothesis was that glycine will improve variables, and thus significance was set at one-tail.||||||>0.05
72405307|NCT01417481|144318464|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||t-test, 1 sided|The hypothesis was that glycine will improve inflammatory biomarkers, and thus statistical significance was set at one-tail.||||||>0.05
72405308|NCT01417481|144318465|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||t-test, 1 sided|The hypothesis was that glycine will improve inflammatory biomarkers, and thus statistical significance was set at one-tail.||||||>0.05
72405309|NCT01417481|144318466|SUPERIORITY_OR_OTHER||||||=|0.061|TWO_SIDED||||||t-test, 1 sided|The hypothesis was that glycine will improve inflammatory biomarkers, and thus statistical significance was set at one-tail.||||||=0.061
72492597|NCT04872101|144513783|SUPERIORITY||Risk Difference (RD)|22.9|||<|0.001|TWO_SIDED|95.0|16.0|29.8||Evaluated at a 5% significance level (two-sided) using hierarchical tests, alpha splitting, and alpha recycling to control overall type 1 error at 5% (two-sided)|Cochran-Mantel-Haenszel|Stratified by region and baseline IGA-CHE score.|Mantel-Haenszel risk difference, stratified by region and baseline IGA-CHE score.|Based on the primary analysis of the primary estimand 'composite'. Subjects with missing data, subjects who received rescue treatment, or subjects who permanently discontinued IMP were considered non-responders.||29.8|16.0|<0.001
72492598|NCT04872101|144513784|SUPERIORITY||Risk Difference (RD)|6.5||||0.043|TWO_SIDED|95.0|0.8|12.3||Evaluated at a 5% significance level (two-sided) using hierarchical tests, alpha splitting, and alpha recycling to control overall type 1 error at 5% (two-sided)|Cochran-Mantel-Haenszel|Stratified by region and baseline IGA-CHE score.|Mantel-Haenszel risk difference, stratified by region and baseline IGA-CHE score.|Based on the primary analysis of the primary estimand 'composite'. Subjects with missing data, subjects who received rescue treatment, or subjects who permanently discontinued IMP were considered non-responders.||12.3|0.8|0.043
72492599|NCT04872101|144513785|SUPERIORITY||Risk Difference (RD)|27.4|||<|0.001|TWO_SIDED|95.0|19.0|35.8||Evaluated at a 5% significance level (two-sided) using hierarchical tests, alpha splitting, and alpha recycling to control overall type 1 error at 5% (two-sided).|Cochran-Mantel-Haenszel|Stratified by region and baseline IGA-CHE score.|Mantel-Haenszel risk difference, stratified by region and baseline IGA-CHE score.|Based on the primary analysis of the primary estimand 'composite'. Subjects with missing data, subjects who received rescue treatment, or subjects who permanently discontinued IMP were considered non-responders.||35.8|19.0|<0.001
72517898|NCT05014542|144565686|SUPERIORITY||Mean Difference (Final Values)|-30.0|||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||mean (WOMAC functional disability of group A in Week 15) - mean (WOMAC functional disability of group C in Week 15)|WOMAC functional disability between groups at Week 15. The Shapiro-Wilk test (S-W) tests normality distribution. Furthermore, the comparability of groups regarding specified variables to accept or reject the null hypothesis of equality was tested with the Mann-Whitney U test, with a power of 95 % and a level of significance α = 0,05. Interquartile range (IQR) and SD were analysed to present the statistical dispersion of sample data at specified assessment (the mid-spread).||||<0.001
72517899|NCT05014542|144565687|SUPERIORITY||Mean Difference (Final Values)|-48.4|||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||mean (VAS of group A in Week 15) - mean (VAS of group C in Week 15)|Visual Analogue Scale (VAS) was compared between groups at Week 15, when the acupuncture of group A ended. The Shapiro-Wilk test (S-W) was used to test the data distribution's normality. The comparability of groups to accept or reject the null hypothesis of groups' similarity was tested with the Mann-Whitney U test, with 95% power and a significance level α = 0,05. Interquartile range (IQR) and standard deviation (SD) presented the statistical dispersion of sample data at specified assessments.||||<0.001
72517900|NCT05014542|144565688|SUPERIORITY||Mean Difference (Final Values)|-14.0|||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||mean (KDSQ of group A in Week 15) - mean (KDSQ of group C in Week 15)|The Kidney Deficiency Syndrome Questionnaire (KDSQ) was compared between groups in Week 15. The Shapiro-Wilk test (S-W) tests the normality of data distribution. The comparability of groups regarding the null hypothesis of similarity was tested with the Mann-Whitney U test, with 95% power and a significance level α = 0,05. Interquartile range (IQR) and SD were used to analyse the statistical dispersion of specified sample data at specified assessment.||||<0.001
72624829|NCT00937105|144779044|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.737||||0.3923|TWO_SIDED|95.0|0.49|6.156|||Regression, Cox|Univariate hazard ratio provided because non-significant finding did not enter into multivariate analyses|referent is no substantial lens bioburden|To determine if microbial contamination of lenses is a risk factor for CIE||6.156|0.49|0.3923
72405310|NCT01417481|144318467|SUPERIORITY_OR_OTHER||||||=|0.068|TWO_SIDED||||||t-test, 1 sided|The hypothesis was that glycine will improve inflammatory biomarkers, and thus statistical significance was set at one-tail.||||||=0.068
72405311|NCT01417481|144318468|SUPERIORITY_OR_OTHER||||||=|0.04|TWO_SIDED||||||t-test, 1 sided|The hypothesis was that glycine will improve inflammatory biomarkers, and thus statistical significance was set at one-tail.||||||=0.040
72405312|NCT01417481|144318469|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||t-test, 1 sided|Due to the cross-over, a paired analysis was done. The hypothesis was that glycine will improve variables, and thus significance was set at one-tail.||||||<0.05
72405313|NCT01417481|144318470|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||t-test, 1 sided|Due to the cross-over, paired analysis was done. The hypothesis was that glycine will improve variables, thus significance was set at one-tail.||||||<0.05
72405314|NCT01417481|144318471|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||t-test, 1 sided|Due to the cross-over, a paired analysis was done. The hypothesis was that glycine will improve variables, and thus significance was set at one-tail.||||||<0.01
72405315|NCT01417481|144318472|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||t-test, 1 sided|Due to the cross-over, a paired analysis was done. The hypothesis was that glycine will improve variables, and thus significance was set at one-tail.||||||>0.05
72624830|NCT00937105|144779045|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.316||||0.7943|TWO_SIDED|95.0|0.167|10.393|||Regression, Cox|Univariate hazard ratio provided because non-significant finding did not enter into multivariate analyses|referent is no corneal staining|||10.393|0.167|0.7943
72405316|NCT04296396|144318482|NON_INFERIORITY|A non-inferiority design assumed a noninferiority margin of 5%. For 90% power and 0.025 significance level 1-sided, a total sample size of 4,300 participants was required to state that the IOPP is not inferior to the fixed amount of 20 tablets. Given the short window to assess pain at 1-week post-discharge, a 20% missing rate was incorporated which gives a final sample size of 5,500 (2,750 per group).|Risk Difference (RD)|0.67|||||TWO_SIDED|95.0|-2.03|3.37|||||The risk difference is the rate in the fixed group minus the rate in the IOPP group. IOPP was to be determined as non-inferior if the lower 95% confidence limit for the risk difference is -5 percentage points or greater (i.e., closer to zero).|||3.37|-2.03|
72517901|NCT05014542|144565689|SUPERIORITY||Mean Difference (Final Values)|-774.0|||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||mean (DRUG of A group in Week 15) - mean (DRUG of C group in Week 15)|In Week 15, DRUG was compared between groups. The Shapiro-Wilk test (S-W) was used to test the data distribution's normality. The comparability of groups regarding specified variables to accept or reject the null hypothesis of groups' similarity was tested with the Mann-Whitney U test, with 95% power and a significance level α = 0,05. Interquartile range (IQR) and standard deviation (SD) were calculated to present the statistical dispersion of sample data at specified assessments.||||<0.001
72517902|NCT05014542|144565690|SUPERIORITY||Mean Difference (Final Values)|0.009||||0.8493|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||mean (A group L knee in Week 15) - mean (C group L knee in Week 15)|Active extension of left (L) knees in Week 15 in the between-group analysis. The Shapiro-Wilk test (S-W) was used to test the data distribution's normality. The comparability of groups to accept or reject the null hypothesis of groups' similarity was tested with the Mann-Whitney U test, with 95% power and a significance level α = 0,05. Interquartile range (IQR) and standard deviation (SD) were calculated to present the statistical dispersion of sample data at specified assessments.||||0.8493
72517903|NCT05014542|144565690|SUPERIORITY||Mean Difference (Final Values)|-0.107||||0.69654|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||mean (A group R knee in Week 15) - mean (C group R knee in Week 15)|Active extension of the right (R) knees in Week 15 in the between-group analysis. The Shapiro-Wilk test (S-W) was used to test the data distribution's normality. The comparability of groups to accept or reject the null hypothesis of groups' similarity was tested with the Mann-Whitney U test, with 95% power and a significance level α = 0,05. Interquartile range (IQR) and standard deviation (SD) were calculated to present the statistical dispersion of sample data at specified assessments.||||0.69654
72517904|NCT05014542|144565691|SUPERIORITY||Mean Difference (Final Values)|3.9||||0.49|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||mean (active flexion L knee of group A at Week 15) - mean (active flexion L knee of group C at Week 15)|L knee flexion between groups at Week 15. The Shapiro-Wilk test (S-W) was used to test the data distribution's normality. The comparability of groups to accept or reject the null hypothesis of groups' similarity was tested with the Mann-Whitney U test, with 95% power and a significance level α = 0,05. Interquartile range (IQR) and standard deviation (SD) were calculated to present the statistical dispersion of sample data at specified assessments.||||0.490
72517905|NCT05014542|144565691|SUPERIORITY||Mean Difference (Final Values)|4.7||||0.517|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||mean (active flexion R knee of group A at Week 15) - mean (active flexion R knee of group C at Week 15)|Right (R) knee flexion between groups in Week 15. The Shapiro-Wilk test (S-W) was used to test the data distribution's normality. The comparability of groups regarding specified variables to accept or reject the null hypothesis of groups' similarity was tested with the Mann-Whitney U test, with 95% power and a significance level α = 0,05. Interquartile range (IQR) and standard deviation (SD) were calculated to present the statistical dispersion of sample data at specified assessments.||||0.517
72517906|NCT05014542|144565692|SUPERIORITY||Mean Difference (Final Values)|-3.0||||0.083|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||mean (circumference of L upper leg of group A at Week 15) - mean (circumference of L upper leg of group C at Week 15)|Circumference of the left (L) upper leg between groups analysis at Week 15. For group normality statistics, the Shapiro-Wilk test (S-W) was used. Furthermore, the comparability of groups regarding specified variables to accept or reject the hypothesis of equality was tested with the Mann-Whitney U test, with 95% power and a significance level α = 0,05. Interquartile range (IQR) and SD were analysed to present the statistical dispersion of specified sample data at specified assessment.||||0.083
72517907|NCT05014542|144565692|SUPERIORITY||Mean Difference (Final Values)|3.0||||0.084|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||mean (circumference of R upper leg of group A at Week 15) - mean (circumference of R upper leg of group C at Week 15)|Circumference of the right (R) upper leg between groups analysis at Week 15. For group normality statistics, the Shapiro-Wilk test (S-W) was used. Furthermore, the comparability of groups regarding specified variables to accept or reject the hypothesis of equality was tested with the Mann-Whitney U test, with 95% power and a significance level α = 0,05. Interquartile range (IQR) and SD were analysed to present the statistical dispersion of sample data at specified assessments.||||0.084
72517908|NCT05014542|144565693|SUPERIORITY||Mean Difference (Final Values)|1.3||||0.341|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||mean (circumference of L knee of group A at Week 15) - mean (circumference of L knee of group C at Week 15)|Circumference of the left (L) knee in Week 15 was analysed between groups. The Shapiro-Wilk test (S-W) was used to test the data distribution's normality. The comparability of groups to accept or reject the null hypothesis of groups' similarity was tested with the Mann-Whitney U test, with 95% power and a significance level α = 0,05. Interquartile range (IQR) and standard deviation (SD) were calculated to present the statistical dispersion of sample data at specified assessments.||||0.341
72517909|NCT05014542|144565693|SUPERIORITY||Mean Difference (Final Values)|1.3||||0.317|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||mean (circumference of R knee of group A at Week 15) - mean (circumference of R knee of group C at Week 15)|Circumference of the right (R) knee in between groups at Week 15. The Shapiro-Wilk test (S-W) was used to test the data distribution's normality. The comparability of groups to accept or reject the null hypothesis of groups' similarity was tested with the Mann-Whitney U test, with 95% power and a significance level α = 0,05. Interquartile range (IQR) and standard deviation (SD) were calculated to present the statistical dispersion of sample data at specified assessments.||||0.317
72624831|NCT00937105|144779046|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.674||||0.5894|TWO_SIDED|95.0|0.161|2.822|||Regression, Cox|Univariate hazard ratio provided because non-significant finding did not enter into multivariate analyses|referent is no substantial case bioburden|||2.822|0.161|0.5894
72492600|NCT04872101|144513786|SUPERIORITY||Risk Difference (RD)|23.7|||<|0.001|TWO_SIDED|95.0|15.1|32.2||Evaluated at a 5% significance level (two-sided) using hierarchical tests, alpha splitting, and alpha recycling to control overall type 1 error at 5% (two-sided)|Cochran-Mantel-Haenszel|Stratified by region and baseline IGA-CHE score.|Mantel-Haenszel risk difference, stratified by region and baseline IGA-CHE score.|Based on the primary analysis of the primary estimand 'composite'. Subjects with missing data, subjects who received rescue treatment, or subjects who permanently discontinued IMP were considered non-responders.||32.2|15.1|<0.001
72492601|NCT04872101|144513787|SUPERIORITY||Risk Difference (RD)|29.0|||<|0.001|TWO_SIDED|95.0|21.3|36.7||Evaluated at a 5% significance level (two-sided) using hierarchical tests, alpha splitting, and alpha recycling to control overall type 1 error at 5% (two-sided)|Cochran-Mantel-Haenszel|Stratified by region and baseline IGA-CHE score.|Mantel-Haenszel risk difference, stratified by region and baseline IGA-CHE score.|Based on the primary analysis of the primary estimand 'composite'. Subjects with missing data, subjects who received rescue treatment, or subjects who permanently discontinued IMP were considered non-responders.||36.7|21.3|<0.001
72492602|NCT04872101|144513788|SUPERIORITY||Risk Difference (RD)|18.3|||<|0.001|TWO_SIDED|95.0|11.0|25.6||Evaluated at a 5% significance level (two-sided) using hierarchical tests, alpha splitting, and alpha recycling to control overall type 1 error at 5% (two-sided)|Cochran-Mantel-Haenszel|Stratified by region and baseline IGA-CHE score.|Mantel-Haenszel risk difference, stratified by region and baseline IGA-CHE score.|Based on the primary analysis of the primary estimand 'composite'. Subjects with missing data, subjects who received rescue treatment, or subjects who permanently discontinued IMP were considered non-responders.||25.6|11.0|<0.001
72492603|NCT04872101|144513789|SUPERIORITY||Risk Difference (RD)|6.6||||0.031|TWO_SIDED|95.0|1.1|12.0||Evaluated at a 5% significance level (two-sided) using hierarchical tests, alpha splitting, and alpha recycling to control overall type 1 error at 5% (two-sided)|Cochran-Mantel-Haenszel|Stratified by region and baseline IGA-CHE score.|Mantel-Haenszel risk difference, stratified by region and baseline IGA-CHE score.|Based on the primary analysis of the primary estimand 'composite'. Subjects with missing data, subjects who received rescue treatment, or subjects who permanently discontinued IMP were considered non-responders.||12.0|1.1|0.031
72492604|NCT04872101|144513790|SUPERIORITY||Risk Difference (RD)|25.0|||<|0.001|TWO_SIDED|95.0|17.5|32.5||Evaluated at a 5% significance level (two-sided) using hierarchical tests, alpha splitting, and alpha recycling to control overall type 1 error at 5% (two-sided)|Cochran-Mantel-Haenszel|Stratified by region and baseline IGA-CHE score.|Mantel-Haenszel risk difference, stratified by region and baseline IGA-CHE score.|Based on the primary analysis of the primary estimand 'composite'. Subjects with missing data, subjects who received rescue treatment, or subjects who permanently discontinued IMP were considered non-responders.||32.5|17.5|<0.001
72492605|NCT04872101|144513791|SUPERIORITY||Risk Difference (RD)|16.9|||<|0.001|TWO_SIDED|95.0|10.2|23.7||Evaluated at a 5% significance level (two-sided) using hierarchical tests, alpha splitting, and alpha recycling to control overall type 1 error at 5% (two-sided)|Cochran-Mantel-Haenszel|Stratified by region and baseline IGA-CHE score.|Mantel-Haenszel risk difference, stratified by region and baseline IGA-CHE score.|Based on the primary analysis of the primary estimand 'composite'. Subjects with missing data, subjects who received rescue treatment, or subjects who permanently discontinued IMP were considered non-responders.||23.7|10.2|<0.001
72492606|NCT04872101|144513792|SUPERIORITY||Risk Difference (RD)|26.0|||<|0.001|TWO_SIDED|95.0|17.0|35.1||Evaluated at a 5% significance level (two-sided) using hierarchical tests, alpha splitting, and alpha recycling to control overall type 1 error at 5% (two-sided)|Cochran-Mantel-Haenszel|Stratified by region and baseline IGA-CHE score.|Mantel-Haenszel risk difference, stratified by region and baseline IGA-CHE score.|Based on the primary analysis of the primary estimand 'composite'. Subjects with missing data, subjects who received rescue treatment, or subjects who permanently discontinued IMP were considered non-responders.||35.1|17.0|<0.001
72492607|NCT04872101|144513793|SUPERIORITY||Risk Difference (RD)|29.6|||<|0.001|TWO_SIDED|95.0|21.7|37.4||Evaluated at a 5% significance level (two-sided) using hierarchical tests, alpha splitting, and alpha recycling to control overall type 1 error at 5% (two-sided)|Cochran-Mantel-Haenszel|Stratified by region and baseline IGA-CHE score.|Mantel-Haenszel risk difference, stratified by region and baseline IGA-CHE score.|Based on the primary analysis of the primary estimand 'composite'. Subjects with missing data, subjects who received rescue treatment, or subjects who permanently discontinued IMP were considered non-responders.||37.4|21.7|<0.001
72492608|NCT04872101|144513794|SUPERIORITY||Risk Difference (RD)|20.5|||<|0.001|TWO_SIDED|95.0|13.1|27.8||Evaluated at a 5% significance level (two-sided) using hierarchical tests, alpha splitting, and alpha recycling to control overall type 1 error at 5% (two-sided)|Cochran-Mantel-Haenszel|Stratified by region and baseline IGA-CHE score.|Mantel-Haenszel risk difference, stratified by region and baseline IGA-CHE score.|Based on the primary analysis of the primary estimand 'composite'. Subjects with missing data, subjects who received rescue treatment, or subjects who permanently discontinued IMP were considered non-responders.||27.8|13.1|<0.001
72517910|NCT05014542|144565694|SUPERIORITY||Mean Difference (Final Values)|-33.0|||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||mean (WOMAC total of group A in Week 24) -mean (WOMAC total of group C in Week 24)|WOMAC total was analysed in Week 24 between groups, nine weeks after acupuncture ended. The Shapiro-Wilk test (S-W) tested the normality of the distribution. The comparability of groups regarding specified variables to accept or reject the null hypothesis of equality was tested with the Mann-Whitney U test, with 95 % power and a level of significance α = 0,05. Interquartile range (IQR) and SD were analysed to present the statistical dispersion of specified sample data at specified assessments.||||<0.001
72517911|NCT05014542|144565695|SUPERIORITY||Mean Difference (Final Values)|-6.5|||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||mean (WOMAC pain of group A at Week 24) - mean (WOMAC pain of group C at Week 24)|WOMAC pain was analysed between groups 9 weeks after acupuncture ended in Week 24. The Shapiro-Wilk test (S-W) tested the normality distribution. Furthermore, the comparability of groups regarding specified variables to accept or reject the hypothesis of equality was tested with the Mann-Whitney U test, with 95% power and a significance level α = 0,05. Interquartile range (IQR) and SD were analysed to present the statistical dispersion of specified sample data (the mid-spread).||||<.001
72624832|NCT00937105|144779047|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.406||||0.1742|TWO_SIDED|95.0|0.678|8.537||Univariate hazard ratio provided because non-significant finding did not enter into multivariate analyses|Regression, Cox||referent is no substantial overall lid bioburden|||8.537|0.678|0.1742
72492609|NCT04872101|144513795|SUPERIORITY||Risk Difference (RD)|22.2|||<|0.001|TWO_SIDED|95.0|15.4|29.0||Evaluated at a 1% significance level (two-sided) using hierarchical tests, alpha splitting, and alpha recycling to control overall type 1 error at 5% (two-sided)|Cochran-Mantel-Haenszel|Stratified by region and baseline IGA-CHE score.|Mantel-Haenszel risk difference, stratified by region and baseline IGA-CHE score.|Based on the primary analysis of the primary estimand 'composite'. Subjects with missing data, subjects who received rescue treatment, or subjects who permanently discontinued IMP were considered non-responders.||29.0|15.4|<0.001
72405317|NCT04296396|144318483|SUPERIORITY||Risk Ratio (RR)|1.22||||0.046|TWO_SIDED|96.25|0.99|1.51|||Chi-squared||Confidence interval is 96.25% due to false discovery rate adjustment|||1.51|0.99|0.046
72492610|NCT04872101|144513796|SUPERIORITY||Risk Difference (RD)|31.3|||<|0.001|TWO_SIDED|95.0|23.1|39.5||Evaluated at a 1% significance level (two-sided) using hierarchical tests, alpha splitting, and alpha recycling to control overall type 1 error at 5% (two-sided)|Cochran-Mantel-Haenszel|Stratified by region and baseline IGA-CHE score.|Mantel-Haenszel risk difference, stratified by region and baseline IGA-CHE score.|Based on the primary analysis of the primary estimand 'composite'. Subjects with missing data, subjects who received rescue treatment, or subjects who permanently discontinued IMP were considered non-responders.||39.5|23.1|<0.001
72492611|NCT04872101|144513797|SUPERIORITY||Risk Difference (RD)|31.0|||<|0.001|TWO_SIDED|95.0|22.7|39.3||Evaluated at a 1% significance level (two-sided) using hierarchical tests, alpha splitting, and alpha recycling to control overall type 1 error at 5% (two-sided)|Cochran-Mantel-Haenszel|Stratified by region and baseline IGA-CHE score.|Mantel-Haenszel risk difference, stratified by region and baseline IGA-CHE score.|Based on the primary analysis of the primary estimand 'composite'. Subjects with missing data, subjects who received rescue treatment, or subjects who permanently discontinued IMP were considered non-responders.||39.3|22.7|<0.001
72492612|NCT04872101|144513798|SUPERIORITY||Mean Difference (Net)|-45.5|||<|0.001|TWO_SIDED|95.0|-56.4|-34.6||Evaluated at a 1% significance level (two-sided) using hierarchical tests, alpha splitting, and alpha recycling to control overall type 1 error at 5% (two-sided)|ANCOVA|Adjusted for treatment, region, baseline IGA-CHE score, and baseline HECSI score.||Primary analysis of primary estimand 'composite'. Missing data for subjects who did not attend the visit was imputed as WOCF (including baseline value). For subjects who received rescue treatment or subjects who have permanently discontinued the IMP, observed data was considered non-response by using WOCF (including baseline value).||-34.6|-56.4|<0.001
72492613|NCT04872101|144513799|SUPERIORITY||Mean Difference (Net)|-3.9|||<|0.001|TWO_SIDED|95.0|-5.0|-2.8||Evaluated at a 1% significance level (two-sided) using hierarchical tests, alpha splitting, and alpha recycling to control overall type 1 error at 5% (two-sided)|ANCOVA|Adjusted for treatment, region, baseline IGA-CHE score, and baseline DLQI score.||Primary analysis of primary estimand 'composite'. Missing data for subjects who did not attend the visit was imputed as WOCF (including baseline value). For subjects who received rescue treatment or subjects who have permanently discontinued the IMP, observed data was considered non-response by using WOCF (including baseline value).||-2.8|-5.0|<0.001
72492614|NCT04872101|144513800|SUPERIORITY||Mean Difference (Net)|-1.9|||<|0.001|TWO_SIDED|95.0|-2.4|-1.4||Evaluated at a 1% significance level (two-sided) using hierarchical tests, alpha splitting, and alpha recycling to control overall type 1 error at 5% (two-sided)|ANCOVA|Adjusted for treatment, region, baseline IGA-CHE score, and baseline HESD score.||Primary analysis of primary estimand 'composite'. Missing data for subjects who did not attend the visit was imputed as WOCF (including baseline value). For subjects who received rescue treatment or subjects who have permanently discontinued the IMP, observed data was considered non-response by using WOCF (including baseline value).||-1.4|-2.4|<0.001
72517912|NCT05014542|144565696|SUPERIORITY||Mean Difference (Final Values)|-2.3|||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||mean (WOMAC stiffness of group A in Week 24) - mean (WOMAC stiffness of group C in Week 24)|WOMAC stiffness between groups A and C in Week 24, 9 weeks after acupuncture ended. The Shapiro-Wilk test (S-W) tests the normality of distribution. Group comparability was tested with the Mann-Whitney U test with 95 % power and a level of significance α=0,05. Interquartile range (IQR) and SD were analysed to present the statistical dispersion of specified sample data at specified assessments.||||<0.001
72517913|NCT05014542|144565697|SUPERIORITY||Mean Difference (Final Values)|-24.3|||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||mean (WOMAC functional disability of group A in Week 24) - mean (WOMAC functional disability of group C in Week 24)|WOMAC functional disability at Week 24 was analysed between groups. The Shapiro-Wilk test (S-W) tests the normality of data. The comparability of groups regarding specified variables (to accept or reject the null hypothesis of comparability) was tested with the Mann-Whitney U test with 95% power and a level of significance α = 0,05. Interquartile range (IQR) and SD were analysed to present the statistical dispersion of specified sample data at specified assessments.||||<0.001
72517914|NCT05014542|144565698|SUPERIORITY||Mean Difference (Final Values)|-45.7|||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||mean (VAS in Week 24 of group A) - mean (VAS in Week 24 of group C)|VAS was compared between groups in Week 24. For group normality statistics, the Shapiro-Wilk test (S-W) was used. The comparability of groups regarding specified variables to accept or reject the hypothesis of equality was tested with the Mann-Whitney U test, with 95% power and a significance level α = 0,05. Interquartile range (IQR) and SD were analysed to present the statistical dispersion of sample data.||||<0.001
72577158|NCT00264550|144680887|SUPERIORITY_OR_OTHER||||||<|0.001||||||The positive test is defined if the comparison between combined golimumab+MTX and Group I is significant at the 0.05, and at least one of the pair-wise comparisons is also significant at the 0.05.|ANOVA on van der Waerden normal scores.|||Null hypothesis: No difference in HAQ response at Wk 24 comparing Groups I and Combined Golimumab + Methotrexate (MTX) at 0.05 level of significance.||||<0.001
72577159|NCT00264550|144680887|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA on van der Waerden normal scores.|||Null hypothesis: No difference in HAQ response at Wk 24 comparing Groups I and III at 0.05 level of significance.||||<0.001
72577160|NCT00264550|144680887|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA on van der Waerden normal scores.|||Null hypothesis: No difference in HAQ response at Wk 24 comparing Groups I and IV at 0.05 level of significance.||||<0.001
72405318|NCT04296396|144318484|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
72405319|NCT04296396|144318485|SUPERIORITY||Median Difference (Net)|-5.0|||<|0.001|TWO_SIDED|97.5|-6.6|-3.5|||quantile regression||Confidence interval is 97.5% due to false discovery rate adjustment|||-3.5|-6.6|<0.001
72492615|NCT04872101|144513801|SUPERIORITY||Median Difference (Net)|-2.0|||<|0.001|TWO_SIDED|95.0|-2.5|-1.4||Evaluated at a 1% significance level (two-sided) using hierarchical tests, alpha splitting, and alpha recycling to control overall type 1 error at 5% (two-sided)|ANCOVA|Adjusted for treatment, region, baseline IGA-CHE score, and baseline HESD itch score.||Primary analysis of primary estimand 'composite'. Missing data for subjects who did not attend the visit was imputed as WOCF (including baseline value). For subjects who received rescue treatment or subjects who have permanently discontinued the IMP, observed data was considered non-response by using WOCF (including baseline value).||-1.4|-2.5|<0.001
72517915|NCT05014542|144565699|SUPERIORITY||Mean Difference (Final Values)|-11.1|||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||mean (KDSQ in Week 24 of group A) - mean (KDSQ in Week 24 of group C)|KDSQ between groups in Week 24. For group normality statistics, the Shapiro-Wilk test (S-W) was used. The comparability of groups regarding specified variables to accept or reject the hypothesis of equality was tested with the Mann-Whitney U test, with 95% power and a significance level α = 0,05. Interquartile range (IQR) and SD were analysed to present the statistical dispersion of sample data.||||<0.001
72517916|NCT05014542|144565700|SUPERIORITY||Mean Difference (Final Values)|-581.5|||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||mean (DRUG in Week 24 of group A) - mean (DRUG in Week 24 of group C)|The DRUG between groups in Week 24. For group normality statistics, the Shapiro-Wilk test (S-W) was used. Furthermore, the comparability of groups regarding specified variables to accept or reject the hypothesis of equality was tested with the Mann-Whitney U test, with 95% power and a significance level α = 0,05. Interquartile range (IQR) and SD were analysed to present the statistical dispersion of sample data.||||<0.001
72517917|NCT05014542|144565701|SUPERIORITY||Mean Difference (Final Values)|0.0|||||TWO_SIDED||||||||mean (Act ext L of A group in Week 24) - mean (Act ext L of C group in Week 24)|Left (L) knee analysis between groups A and C in Week 24. For group normality statistics, the Shapiro-Wilk test (S-W) was used. Furthermore, the comparability of groups regarding specified variables to accept or reject the hypothesis of comparability was tested with the Mann-Whitney U test, with 95% statistical power and a significance level α = 0,05. Interquartile range (IQR) and SD were analysed to present the statistical dispersion of sample data at assessment.||||
72517918|NCT05014542|144565701|SUPERIORITY||Mean Difference (Final Values)|0.0|||||TWO_SIDED||||||||mean (Act ext R knee of A group in Week 24) - mean (Act ext R knee of C group in Week 24)|Right (R) knee analysis between groups at Week 24. For group normality statistics, the Shapiro-Wilk test (S-W) was used. Furthermore, the comparability of groups regarding specified variables to accept or reject the hypothesis of comparability between groups was tested by the Mann-Whitney U test, with 95% power and a significance level α = 0,05. Interquartile range (IQR) and SD were analysed to present the statistical dispersion of sample data at specified assessment.||||
72492616|NCT04872101|144513802|SUPERIORITY||Mean Difference (Net)|-2.0|||<|0.001|TWO_SIDED|95.0|-2.6|-1.5||Evaluated at a 1% significance level (two-sided) using hierarchical tests, alpha splitting, and alpha recycling to control overall type 1 error at 5% (two-sided)|ANCOVA|Adjusted for treatment, region, baseline IGA-CHE score, and baseline HESD pain score.||Primary analysis of primary estimand 'composite'. Missing data for subjects who did not attend the visit was imputed as WOCF (including baseline value). For subjects who received rescue treatment or subjects who have permanently discontinued the IMP, observed data was considered non-response by using WOCF (including baseline value).||-1.5|-2.6|<0.001
72492617|NCT04872101|144513803|SUPERIORITY||Median Difference (Net)|-0.81|||<|0.001|TWO_SIDED|95.0|-0.99|-0.62||Evaluated at a 1% significance level (two-sided) using hierarchical tests, alpha splitting, and alpha recycling to control overall type 1 error at 5% (two-sided)|ANCOVA|Adjusted for treatment, region, baseline IGA-CHE score, and baseline HEIS score.||Primary analysis of primary estimand 'composite'. Missing data for subjects who did not attend the visit was imputed as WOCF (including baseline value). For subjects who received rescue treatment or subjects who have permanently discontinued the IMP, observed data was considered non-response by using WOCF (including baseline value).||-0.62|-0.99|<0.001
72492618|NCT04872101|144513804|SUPERIORITY||Mean Difference (Net)|-0.82|||<|0.001|TWO_SIDED|95.0|-1.01|-0.62||Evaluated at a 1% significance level (two-sided) using hierarchical tests, alpha splitting, and alpha recycling to control overall type 1 error at 5% (two-sided)|ANCOVA|Adjusted for treatment, region, baseline IGA-CHE score, and baseline HEIS PDAL score.||Primary analysis of primary estimand 'composite'. Missing data for subjects who did not attend the visit was imputed as WOCF (including baseline value). For subjects who received rescue treatment or subjects who have permanently discontinued the IMP, observed data was considered non-response by using WOCF (including baseline value).||-0.62|-1.01|<0.001
72517919|NCT05014542|144565702|SUPERIORITY||Mean Difference (Final Values)|-0.9||||0.953|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||mean (L knee act flexion of group A in Week 24) - mean (L knee act flexion of group C in Week 24)|Left (L) knee flexion between groups at Week 24. The Shapiro-Wilk test (S-W) tests the normality of the distribution. Furthermore, the comparability of groups regarding specified variables to accept or reject the null hypothesis of equality was tested with the Mann-Whitney U test, with 95% power and a level of significance α = 0,05. Standard deviation (SD) was calculated to present the statistical dispersion of specified sample data at a specified assessment (time-point).||||0.953
72517920|NCT05014542|144565702|SUPERIORITY||Mean Difference (Final Values)|1.8||||0.491|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||mean (R knee act flexion of group A in Week 24) - mean (R knee act flexion of group C in Week 24)|Right (R) knee flexion between groups at Week 24. The Shapiro-Wilk test (S-W) tests the normality of the distribution. Furthermore, the comparability of groups regarding specified variables to accept or reject the null hypothesis of comparability was tested with the Mann-Whitney U test, with 95% power and a level of significance α = 0,05. Standard deviation (SD) was calculated to present the statistical dispersion of sample data at an assessment.||||0.491
72517921|NCT05014542|144565703|SUPERIORITY||Mean Difference (Final Values)|1.6||||0.261|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||mean (circumference of L upper leg of group A in Week 24) - mean (circumference of L upper leg of group C in Week 24)|Circumference of the left (L) upper leg between groups in Week 24. The Shapiro-Wilk test (S-W) was used to test the normality of a distribution. The comparability of groups regarding specified variables to accept or reject the hypothesis of groups comparability was tested with the Mann-Whitney U test, with 95% power and a significance level α = 0,05. Interquartile range (IQR) and SD were analysed to present the statistical dispersion of sample data at assessments.||||0.261
72577161|NCT00264550|144680887|SUPERIORITY_OR_OTHER|||||||0.24|||||||ANOVA on van der Waerden normal scores.|||Null hypothesis: No difference in HAQ response at Wk 24 comparing Groups I and II at 0.05 level of significance.||||0.240
72405320|NCT04296396|144318486|SUPERIORITY||Median Difference (Net)|-15.0|||<|0.001|TWO_SIDED|98.75|-19.2|-10.8|||quartile regression||Confidence interval is 98.75% due to false discovery rate adjustment|||-10.8|-19.2|<0.001
72405321|NCT04296396|144318487|SUPERIORITY||Median Difference (Net)|0.0||||1|TWO_SIDED|95.0|0.0|0.0|||quantile regression|||||0|0|1.0
72405322|NCT04296396|144318488|SUPERIORITY||Risk Ratio (RR)|0.96||||0.52|TWO_SIDED|95.0|0.85|1.09|||Chi-squared|||||1.09|0.85|0.52
72492619|NCT04872101|144513805|SUPERIORITY||Risk Difference (RD)|26.4|||<|0.001|TWO_SIDED|95.0|17.0|35.9||Evaluated at a 1% significance level (two-sided) using hierarchical tests, alpha splitting, and alpha recycling to control overall type 1 error at 5% (two-sided)|Cochran-Mantel-Haenszel|Stratified by region and baseline IGA-CHE score.|Mantel-Haenszel risk difference, stratified by region and baseline IGA-CHE score.|Based on the primary analysis of the primary estimand 'composite'. Subjects with missing data, subjects who received rescue treatment, or subjects who permanently discontinued IMP were considered non-responders.||35.9|17.0|<0.001
72517922|NCT05014542|144565703|SUPERIORITY||Mean Difference (Final Values)|2.1||||0.273|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||mean (circumference of R upper leg of group A in Week 24) - mean (circumference of R upper leg of group C in Week 24)|Circumference of the R upper leg between groups at Week 24. The Shapiro-Wilk test (S-W) was used to test the normality of distribution. The comparability of groups regarding specified variables (null hypothesis) was tested with the Mann-Whitney U test, with 95% power and a significance level α = 0,05. Interquartile range (IQR) and SD were analysed to present the statistical dispersion of sample data at assessments.||||0.273
72517923|NCT05014542|144565704|SUPERIORITY||Mean Difference (Final Values)|1.2||||0.445|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||mean (circumference of L knees in Week 24 of group A) - mean (circumference of L knees in Week 24 of group C)|Circumference of left (L) knees in Week 24, in between-groups. The Shapiro-Wilk test (S-W) tests normality distribution. The comparability of groups regarding specified variables to accept or reject the null hypothesis of similarity was tested with the Mann-Whitney U test with 95% power and a level of significance α = 0,05. Standard deviation was calculated to present the statistical dispersion of sample data at an assessment.||||0.445
72517924|NCT05014542|144565704|SUPERIORITY||Mean Difference (Final Values)|1.6||||0.26|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||mean (circumference of R knees in Week 24 of group A) - mean (circumference of R knees in Week 24 of group C)|Circumference of right (R) knees at Week 24 was analysed between groups. The Shapiro-Wilk test (S-W) tests normality distribution. The comparability of groups regarding specified variables to accept or reject the null hypothesis of similarity was tested with the Mann-Whitney U test with 95% power and a level of significance α = 0,05. Standard deviation was calculated to present the statistical dispersion of sample data at assessments.||||0.260
72517925|NCT05014542|144565705|SUPERIORITY||Mean Difference (Final Values)|-34.4|||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||mean (WOMAC total of group A in Week 39) - mean (WOMAC total of group A in Week 0)|Western Ontario and McMaster University Osteoarthritis Index (WOMAC) total of group A in Week 39 (24 weeks after acupunctures ended) was compared with the pre-experimental baseline assessment by within-group analysis. The Shapiro-Wilk test (S-W) tests normality distribution. The null hypothesis at weeks 0 and 39 was tested with the Mann-Whitney U test with 95 % power and a level of significance α=0,05. Standard deviation (SD) was calculated to present the statistical dispersion of the sample.||||<0.001
72517926|NCT05014542|144565705|SUPERIORITY||Mean Difference (Final Values)|-39.1|||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||mean (WOMAC total in Week 39 of group C) - mean (WOMAC total in Week 0 of group C).|WOMAC total of group C in Week 39 was tested for the significance level and mean difference by within-group analysis. The Shapiro-Wilk test (S-W) tests normality distribution. WOMAC total at Week 0 (pre-experimental baseline assessment) and Week 39 were compared to test the null hypothesis of group comparability by the Mann-Whitney U test with 95 % power and a level of significance α=0,05. Standard deviation (SD) was calculated to present the statistical dispersion of a sample.||||< 0.001
72517927|NCT05014542|144565706|SUPERIORITY||Mean Difference (Final Values)|-6.2|||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||mean (WOMAC pain in Week 39 of group A) - mean (WOMAC pain in Week 0 of group A)|The pain subscale of the WOMAC index of group A in Week 39 (24 weeks after acupunctures ended) was compared with baseline by within-group analysis. The Shapiro-Wilk test (S-W) was used for testing the normality of the distribution. The null hypothesis of groups' similarity was tested with the Mann-Whitney U test, with 95% power and a significance level α = 0,05. Interquartile range and standard deviation were calculated to present the statistical dispersion of sample data at assessments.||||<0.001
72517928|NCT05014542|144565706|SUPERIORITY||Mean Difference (Final Values)|-7.0|||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||mean (WOMAC pain in Week 39 of group C) - mean (WOMAC pain in Week 0 of group C)|The pain subscale of the WOMAC index of group C in Week 39 (end of acupuncture of group C) was compared with the pre-experimental baseline values by within-group analysis. The Shapiro-Wilk test (S-W) was used for testing the normality of the distribution. The null hypothesis of groups' similarity was tested with the Mann-Whitney U test, with 95% power and a significance level α = 0,05. Interquartile range and standard deviation were calculated to present the statistical dispersion of data.||||<0.001
72517929|NCT05014542|144565707|SUPERIORITY||Mean Difference (Final Values)|-2.6|||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||mean (WOMAC stiffness in Week 39 of group A) - mean (WOMAC stiffness in Week 0 of group A)|The stiffness subscale of the WOMAC index of group A in Week 39 (24 weeks after acupuncture of group A ended) was compared with the pre-experimental baseline values by within-group analysis. The Shapiro-Wilk test (S-W) was used for testing the normality of the distribution. The null hypothesis of groups' similarity was tested with the Mann-Whitney U test, with 95% power and a significance level α=0,05. Interquartile range and SD were calculated to present the statistical dispersion of the data.||||<0.001
72577162|NCT00264550|144680888|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||||||<0.001
72577163|NCT00264550|144680888|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||||||<0.001
72577164|NCT00264550|144680888|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||||||<0.001
72577165|NCT00264550|144680888|SUPERIORITY_OR_OTHER|||||||0.187||95.0|||||Chi-squared|||||||0.187
72577166|NCT00264550|144680889|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA on van der Waerden noramal|||||||<0.001
72577167|NCT00264550|144680889|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA on van der Waerden normal scores|||||||<0.001
72577168|NCT00264550|144680889|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA on van der Waerden normal scores|||||||<0.001
72577169|NCT00264550|144680889|SUPERIORITY_OR_OTHER|||||||0.097||95.0|||||ANOVA on van der Waerden normal scores|||||||0.097
72492620|NCT03354663|144513811|OTHER|Single arm trial|Proportion|0.047|||<|0.0001|ONE_SIDED|95.0||0.0864|||Binomial Exact Test|||"The hypothesis is formally expressed as:~H0: P ≥ 16.2% Ha: P \< 16.2%, where P is the percentage of subjects with a primary safety endpoint event. The hypothesis will be tested based on a one-sided exact test of binomial proportions at the one-sided 0.05 alpha level."||0.0864||<0.0001
72492621|NCT03354663|144513812|OTHER|"The hypothesis is formally expressed as:~H0: P \< 90% Ha: P ≥ 90%, where P is the percentage of subjects with acute success. The hypothesis will be tested based on a one-sided exact test of binomial proportions at the one-sided 0.05 alpha level. Rejection of the null hypothesis will indicate study success."|Proportion|0.98||||0.0001|ONE_SIDED|95.0|0.9495||||Binomial Exact Test||||||0.9495|0.0001
72492622|NCT03354663|144513817|OTHER||Kaplan-Meier Survival Estimate|82.2|||||TWO_SIDED|95.0|74.7|87.6|||||Kaplan-Meier estimate of freedom from recurrence at 1-year|Kaplan Meier Estimate of freedom from recurrence.||87.6|74.7|
72492623|NCT03354663|144513818|OTHER||Kaplan-Meier survival estimate|68.2|||||TWO_SIDED|95.0|59.9|75.1||||||Kaplan-Meier estimate of freedom from recurrence or need for anti-arrhythmic medication||75.1|59.9|
72492624|NCT03691974|144513832|SUPERIORITY||Least Square (LS) Mean Difference|0.4||||0.4192|TWO_SIDED|95.0|-0.55|1.32||Analyses are based on Mixed Model for Repeated Measures (MMRM) model with terms for baseline nerve conduction test score, treatment, screening Kellgren-Lawrence score, index joint, visit, and treatment by visit interaction.|Mixed Model for Repeated Measures (MMRM)|||||1.32|-0.55|0.4192
72492625|NCT03691974|144513833|SUPERIORITY||LS Mean Difference|0.4||||0.0521|TWO_SIDED|95.0|0.0|0.8||Analyses are based on MMRM model with terms for baseline nerve conduction test score, treatment, screening Kellgren-Lawrence score, index joint, visit, and treatment by visit interaction.|MMRM|||||0.80|-0.00|0.0521
72492626|NCT03691974|144513834|SUPERIORITY||LS Mean Difference|1.3||||0.1593|TWO_SIDED|95.0|-0.52|3.15||Analyses are based on MMRM model with terms for baseline nerve conduction test score, treatment, screening Kellgren-Lawrence score, index joint, visit, and treatment by visit interaction.|MMRM|||||3.15|-0.52|0.1593
72492627|NCT03691974|144513835|SUPERIORITY||LS Mean Difference|-0.2||||0.7757|TWO_SIDED|95.0|-1.59|1.19||Analyses are based on MMRM model with terms for baseline nerve conduction test score, treatment, screening Kellgren-Lawrence score, index joint, visit, and treatment by visit interaction.|MMRM|||||1.19|-1.59|0.7757
72492628|NCT03691974|144513836|SUPERIORITY||LS Mean Difference|-0.4||||0.6063|TWO_SIDED|95.0|-1.87|1.09||Analyses are based on MMRM model with terms for baseline nerve conduction test score, treatment, screening Kellgren-Lawrence score, index joint, visit, and treatment by visit interaction.|MMRM|||||1.09|-1.87|0.6063
72517930|NCT05014542|144565707|SUPERIORITY||Mean Difference (Final Values)|-3.0|||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||mean (WOMAC stiffness in Week 39 of group C) - mean (WOMAC stiffness in Week 0 of group C)|The stiffness subscale of the WOMAC index of group C in Week 39 (end of acupuncture of group C) was compared with the pre-experimental baseline values by within-group analysis. The Shapiro-Wilk test (S-W) was used for testing the normality of the distribution. The null hypothesis of groups' similarity was tested with the Mann-Whitney U test, with 95% power and a significance level α = 0,05. Interquartile range and standard deviation were calculated to present the statistical dispersion of data.||||<0.001
72517931|NCT05014542|144565708|SUPERIORITY||Mean Difference (Final Values)|-25.3|||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||mean (WOMAC functional disability in Week 39 of group A) - mean(WOMAC functional disability in Week 0 of group A)|The functional disability subscale of the WOMAC index of group A in Week 39 (24 weeks after acupuncture of group A ended) was compared with baseline values by within-group analysis. The Shapiro-Wilk test (S-W) was used for testing the normality of the distribution. The null hypothesis of groups' similarity was tested with the Mann-Whitney U test, with 95% power and a significance level α=0,05. Interquartile range and SD were calculated to present the statistical dispersion of the data.||||<0.001
72517932|NCT05014542|144565708|SUPERIORITY||Mean Difference (Final Values)|-29.6|||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||mean (WOMAC functional disability in Week 39 of group C) - mean (WOMAC functional disability in Week 0 of group C)|The functional disability subscale of the WOMAC index of group C in Week 39 (when acupuncture of group A ended) was compared with baseline values by within-group analysis. The Shapiro-Wilk test (S-W) was used for testing the normality of the distribution. The null hypothesis of groups' similarity was tested with the Mann-Whitney U test, with 95% power and a significance level α=0,05. Interquartile range and SD were calculated to present the statistical dispersion of the data.||||<0.001
72577170|NCT00264550|144680890|SUPERIORITY_OR_OTHER|||||||0.551|||||||ANOVA on van der Waerden normal|||||||0.551
72577171|NCT00264550|144680890|SUPERIORITY_OR_OTHER|||||||0.953|||||||ANOVA on van der Waerden normal scores|||||||0.953
72492629|NCT03691974|144513837|SUPERIORITY||LS Mean Difference|-1.0||||0.4203|TWO_SIDED|95.0|-3.3|1.39||Analyses are based on MMRM model with terms for baseline nerve conduction test score, treatment, screening Kellgren-Lawrence score, index joint, visit, and treatment by visit interaction.|MMRM|||||1.39|-3.30|0.4203
72492630|NCT03691974|144513838|SUPERIORITY||LS Mean Difference|-1.33||||0.001|TWO_SIDED|95.0|-2.123|-0.538||Analyses are based on multiple imputation with MMRM model with terms for baseline WOMAC subscale score, treatment, screening Kellgren-Lawrence score, index joint, visit, and treatment by visit interaction.|MMRM|||||-0.538|-2.123|0.0010
72492631|NCT03691974|144513839|SUPERIORITY||LS Mean Difference|-1.42||||0.0005|TWO_SIDED|95.0|-2.212|-0.625||Analyses were based on multiple imputation with MMRM model with terms for baseline WOMAC subscale score, treatment, screening Kellgren-Lawrence score, index joint, visit, and treatment by visit interaction.|MMRM|||||-0.625|-2.212|0.0005
72492632|NCT03325673|144513866|SUPERIORITY|||||||0.116|||||||Independent t-test|||||||0.116
72492633|NCT03325673|144513867|SUPERIORITY|||||||0.468|||||||t-test, 2 sided|||Insertion||||0.468
72492634|NCT03325673|144513867|SUPERIORITY|||||||0.235|||||||t-test, 2 sided|||After 2 hours||||0.235
72492635|NCT03325673|144513867|SUPERIORITY|||||||0.152|||||||t-test, 2 sided|||End of Day||||0.152
72492636|NCT03325673|144513868|SUPERIORITY|||||||0.488|||||||t-test, 2 sided|||||||0.488
72492637|NCT03325673|144513869|SUPERIORITY|||||||0.072|||||||t-test, 2 sided|||||||0.072
72492638|NCT00590590|144513876|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||||||||||||Ha: Drug 1 \< Drug 2||||
72492639|NCT00590590|144513876|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||||||||||||Ha: Drug 1 \< Placebo||||
72492640|NCT00590590|144513876|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||||||||||||Ha: Drug 2 \< Placebo||||
72492641|NCT00590590|144513877|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2||||||||||||||Ha: Drug 1 \< Drug 2||||
72492642|NCT00590590|144513877|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||||||||||||Ha: Drug 1 \< Placebo||||
72492643|NCT00590590|144513877|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3||||||||||||||Ha: Drug 2 \< Placebo||||
72492644|NCT00590590|144513878|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.1||||||||||||||Ha: Drug 1 \< Drug 2||||
72492645|NCT00590590|144513878|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.7||||||||||||||Ha: Drug 1 \< Placebo||||
72492646|NCT00590590|144513878|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.8||||||||||||||Ha: Drug 2 \< Placebo||||
72517933|NCT05014542|144565709|SUPERIORITY||Mean Difference (Final Values)|-41.2|||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||mean (VAS in Week 39 of group A) - mean (VAS in Week 0 of group A)|VAS of group A in Week 39 (24 weeks after acupuncture of group A ended) was compared with baseline values by within-group analysis. The Shapiro-Wilk test (S-W) was used for testing the normality of the distribution. The null hypothesis of groups' similarity was tested with the Mann-Whitney U test, with 95% power and a significance level α=0,05. Interquartile range and SD were calculated to present the statistical dispersion of the data.||||<0.001
72517934|NCT05014542|144565709|SUPERIORITY||Mean Difference (Final Values)|-31.1|||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||mean (VAS in Week 39 of group C) - mean (VAS in Week 0 of group C)|VAS of group C in Week 39 (when acupuncture of group C ended) was compared with baseline values by within-group analysis. The Shapiro-Wilk test (S-W) was used for testing the normality of the distribution. The null hypothesis of groups' similarity was tested with the Mann-Whitney U test, with 95% power and a significance level α=0,05. Interquartile range and SD were calculated to present the statistical dispersion of the data.||||< 0.001
72517935|NCT05014542|144565710|SUPERIORITY||Mean Difference (Final Values)|-12.6|||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||mean (KDSQ in Week 39 of group A) - mean (KDSQ in Week 0 of group A)|KDSQ of group A in Week 39 (24 weeks after acupuncture of group A ended) was compared with baseline values by within-group analysis. The Shapiro-Wilk test (S-W) was used for testing the normality of the distribution. The null hypothesis of groups' similarity was tested with the Mann-Whitney U test, with 95% power and a significance level α=0,05. Interquartile range and SD were calculated to present the statistical dispersion of the data.||||<0.001
72517936|NCT05014542|144565710|SUPERIORITY||Mean Difference (Final Values)|-11.4|||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||mean (KDSQ in Week 39 of group C) - mean (KDSQ in Week 0 of group C)|KDSQ of group C in Week 39 (when acupuncture of group C ended) was compared with baseline values by within-group analysis. The Shapiro-Wilk test (S-W) was used for testing the normality of the distribution. The null hypothesis of groups' similarity was tested with the Mann-Whitney U test, with 95% power and a significance level α=0,05. Interquartile range and SD were calculated to present the statistical dispersion of the data.||||<0.001
72569532|NCT02856880|144669964|SUPERIORITY_OR_OTHER||LS mean difference|3.04||||0.9967|TWO_SIDED|95.0|-1469.45|1475.52||Obtained from ANCOVA including period and treatment as fixed effects, participant as a random effect and participant-level pre-treatment values and period minus participant-level pre-treatment values as covariates in the model.|ANCOVA||Difference is first named treatment minus second named treatment such that a negative difference indicates a smaller live:dead stain ratio for the first named treatment.|||1475.52|-1469.45|0.9967
72569533|NCT02856880|144669964|SUPERIORITY_OR_OTHER||LS mean difference|766.64||||0.2976|TWO_SIDED|95.0|-703.26|2236.54||Obtained from ANCOVA including period and treatment as fixed effects, participant as a random effect and participant-level pre-treatment values and period minus participant-level pre-treatment values as covariates in the model.|ANCOVA||Difference is first named treatment minus second named treatment such that a negative difference indicates a smaller live:dead stain ratio for the first named treatment.|||2236.54|-703.26|0.2976
72492647|NCT00590590|144513879|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.3||||||||||||||Ha: Drug 1 \< Drug 2||||
72492648|NCT00590590|144513879|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.0||||||||||||||Ha: Drug 1 \< Placebo||||
72492649|NCT00590590|144513879|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3||||||||||||||Ha: Drug 2 \< Placebo||||
72492650|NCT00590590|144513880|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.1||||||||||||||Ha: Drug 1 \< Drug 2||||
72492651|NCT00590590|144513880|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.9||||||||||||||Ha: Drug 1 \< Placebo||||
72492652|NCT00590590|144513880|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.0||||||||||||||Ha: Drug 2 \< Placebo||||
72492653|NCT00590590|144513881|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.3||||||||||||||Ha: Drug 1 \< Drug 2||||
72492654|NCT00590590|144513881|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6||||||||||||||Ha: Drug 1 \< Placebo||||
72492655|NCT00590590|144513881|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.7||||||||||||||Ha: Drug 2 \< Placebo||||
72492656|NCT01602692|144513882|OTHER|||||||0.24|||||||ANOVA|||End of PACU Mean Pain Level p-value between arms||||0.24
72492657|NCT01602692|144513882|OTHER|||||||0.76|||||||ANOVA|||First 24 hrs Post-op Mean Current Pain p-value between arms||||0.76
72492658|NCT01602692|144513882|OTHER|||||||0.78|||||||ANOVA|||First 24 hrs Post-op Mean Worst Pain p-value between arms||||0.78
72492659|NCT01602692|144513882|OTHER|||||||0.41|||||||ANOVA|||First 24 hrs Post-op Mean Least Pain p-value between arms||||0.41
72492660|NCT01602692|144513883|OTHER|||||||0.1|||||||ANOVA|||PACU IV hydromorphone p-value between arms||||0.10
72492661|NCT01602692|144513883|OTHER|||||||0.71|||||||ANOVA|||First 24 hr Post-op oxycodone p-value between arms||||0.71
72492662|NCT00883337|144513911|SUPERIORITY_OR_OTHER|||||||0.5953||95.0||||"Hochberg testing procedure:~* a-priori threshold for statistical significance ≤0.05 for the largest p-value of the 2 pair-wise comparisons~* a-priori threshold for statistical significance ≤0.025 for the other p-value if the largest p-value \>0.05"|Log Rank|Two-sided Log Rank test with the region of enrollment and baseline EDSS stratum as stratification factors||"The study was sized to detect a difference between Teriflunomide and Rebif groups in the time to failure at a significance level of 0.025 with a power of 81%.~Null hypothesis:~* H1: No difference between Teriflunomide 14 mg and Rebif~* H2: No difference between Teriflunomide 7 mg and Rebif"||||0.5953
72492663|NCT00883337|144513911|SUPERIORITY_OR_OTHER|||||||0.519||95.0||||"Hochberg testing procedure:~* a-priori threshold for statistical significance ≤0.05 for the largest p-value of the 2 pair-wise comparisons~* a-priori threshold for statistical significance ≤0.025 for the other p-value if the largest p-value \>0.05"|Log Rank|Two-sided Log Rank test with the region of enrollment and baseline EDSS stratum as stratification factors||"Null hypothesis:~* H1: No difference between Teriflunomide 14 mg and Rebif~* H2: No difference between Teriflunomide 7 mg and Rebif"||||0.5190
72405323|NCT04296396|144318489|SUPERIORITY||Risk Ratio (RR)|0.99||||0.15|TWO_SIDED|95.0|0.98|1.0|||Regression, Linear|||||1.00|0.98|0.15
72492664|NCT01485627|144513964|SUPERIORITY||Adjusted mean difference in difference|0.34||||0.05|TWO_SIDED|95.0|0.06|0.62|||Mixed Models Analysis||Models included fixed-effects terms for phase (pre- vs postrandomization), study arm, and the Phase\*Arm interaction. Estimated effect is the between-arm difference in adjusted mean difference from prerandomization to postrandomization samples.|The primary outcome was a composite of 4 prespecified communication measures matched to the goals of communication training, as follows: Active Patient Participation Coding \[APPC\], Verona VR-CoDES, Prognostic and Treatment Choices \[PTCC\] Informing subscale, and PTCC Balanced Framing subscale. The 4 measures were z-score transformed and averaged to produce the composite measure.||0.62|0.06|0.05
72577172|NCT00264550|144680890|SUPERIORITY_OR_OTHER|||||||0.293|||||||ANOVA on van der waerden normal scores|||||||0.293
72492665|NCT01485627|144513965|SUPERIORITY|||||||0.214|||||||Mixed Models Analysis|||||||0.214
72492666|NCT01485627|144513966|SUPERIORITY||Mean Difference (Final Values)|-0.09||||0.05|TWO_SIDED|95.0|-0.56|0.37|||Mixed Models Analysis|||||0.37|-0.56|0.05
72517937|NCT05014542|144565711|SUPERIORITY||Mean Difference (Final Values)|-361.4||||0.204|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||mean (DRUG in Week 39 of group A) - mean (DRUG in Week 0 of group A)|The DRUG of group A in Week 39 (24 weeks after acupuncture of group A ended) was compared with baseline values by within-group analysis. The Shapiro-Wilk test (S-W) was used for testing the normality of the distribution. The null hypothesis of groups' similarity was tested with the Mann-Whitney U test, with 95% power and a significance level α=0,05. Interquartile range and SD were calculated to present the statistical dispersion of the data.||||0.204
72517938|NCT05014542|144565711|SUPERIORITY||Mean Difference (Final Values)|-305.4||||0.134|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||mean (DRUG in Week 39 of group C) - mean (DRUG in Week 0 of group C)|The DRUG of group C in Week 39 (when acupuncture of group C ended) was compared with baseline values by within-group analysis. The Shapiro-Wilk test (S-W) was used for testing the normality of the distribution. The null hypothesis of groups' similarity was tested with the Mann-Whitney U test, with 95% power and a significance level α=0,05. Interquartile range and SD were calculated to present the statistical dispersion of the data.||||0.134
72517939|NCT05014542|144565712|SUPERIORITY||Mean Difference (Final Values)|-7.53|||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||mean (Lequesne index in Week 24 of A group) - mean (Lequesne index in Week 24 of C group)|The Lequesne index in Week 24 compared two confirmed comparable groups (at baseline), 9 weeks after acupuncture treatment in group A ended, while the C group was still a control. The Shapiro-Wilk test (S-W) tests normality distribution. The between-group comparability test at Week 24 was provided to accept or reject the null hypothesis by the Mann-Whitney U test, with 95 % power and a level of significance α = 0,05. Standard deviation (SD) was calculated to present the statistical dispersion.||||< 0.001
72517940|NCT02146248|144565748|SUPERIORITY_OR_OTHER|||||||0.4795||||||The two-tailed P value equals 0.4795|McNemar|||McNemar paired. Hypothesis is no change in tubal patency status. All subjects know to have bilateral patency in one of the exams during natural cycle||||0.4795
72517941|NCT02431468|144565762|SUPERIORITY||Mean Difference (Net)|6.5|||<|0.1|TWO_SIDED|80.0||||LSM and two-sided 80% CI were provided for treatment group differences and estimated endpoint values. A true mean difference in change from baseline in the SIB (one-sided at α=0.10) of at least 6.5 points in favor of bryostatin groups was assumed.|t-test, 1 sided|||The primary statistical objective for efficacy was to estimate the effect of bryostatin on the mean change in the Severe Impairment Battery (SIB) after 12 weeks of treatment. A linear model was used for both estimation and significance testing. Primary analysis populations were defined as the Full Analysis Set (FAS) and the Completer Analysis Set (CAS)||||<0.1
72517942|NCT02431468|144565762|SUPERIORITY||Mean Difference (Net)|6.5|||<|0.1|TWO_SIDED|80.0|||||t-test, 1 sided|||Change from baseline in SIB in the Completer Analysis Set (CAS)||||<0.1
72517943|NCT03589885|144565765|SUPERIORITY||Odds Ratio (OR)|1014.07|||<|0.0001|TWO_SIDED|95.0|68.83|14940.62|||Regression, Logistic|||PASI 75||14940.62|68.83|<0.0001
72517944|NCT03589885|144565765|SUPERIORITY||Odds Ratio (OR)|96.23|||<|0.0001|TWO_SIDED|95.0|17.22|537.78|||Regression, Logistic|||PASI 75||537.78|17.22|<0.0001
72517945|NCT03589885|144565766|SUPERIORITY||Odds Ratio (OR)|51.46|||<|0.0001|TWO_SIDED|95.0|11.95|221.64|||Regression, Logistic|||||221.64|11.95|<0.0001
72492667|NCT01485627|144513968|SUPERIORITY|||||||0.677|||||||Mixed Models Analysis|||||||0.677
72492668|NCT01485627|144513969|SUPERIORITY|||||||0.19|||||||Mixed Models Analysis|||||||0.19
72517946|NCT03589885|144565766|SUPERIORITY||Odds Ratio (OR)|29.7|||<|0.0001||95.0|7.38|119.57|||Regression, Logistic|||||119.57|7.38|<0.0001
72577173|NCT00264550|144680890|SUPERIORITY_OR_OTHER|||||||0.361|||||||ANOVA on van der Waerden normal scores|||||||0.361
72577174|NCT00696787|144680900|SUPERIORITY_OR_OTHER||Adjusted mean|-0.38||||0.471|TWO_SIDED|95.0|-1.42|0.66|||ANCOVA|||||0.66|-1.42|0.471
72405324|NCT01077960|144318493|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||||||<0.001
72405325|NCT01077960|144318494|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||||||<0.001
72405326|NCT01077960|144318495|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||||||<0.001
72405327|NCT01077960|144318496|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||||||<0.001
72492669|NCT02264990|144513973|SUPERIORITY|A fixed sequence testing procedure was used for analyses of the primary and secondary efficacy endpoints to control for the familywise error rate. If veliparib plus C/P treatment was not statistically significantly better compared to the investigators' choice of standard therapy for the primary efficacy endpoint of OS in LSP+ participants, then statistical significance would not be declared for any of the secondary efficacy endpoints.|Hazard Ratio (HR)|0.644||||0.113|TWO_SIDED|95.0|0.396|1.048||Statistical significance was determined by a two-sided P value ≤ 0.05.|Log Rank|Log rank test stratified by ECOG performance status, investigators' preferred platinum therapy, and gender.|Hazard ratio obtained using the covariate adjusted Cox Proportional Hazard Model with covariates being ECOG performance status, investigators' preferred platinum therapy, and gender.|||1.048|0.396|0.113
72492670|NCT02264990|144513974|OTHER||Hazard Ratio (HR)|0.647||||0.26|TWO_SIDED|95.0|0.388|1.08|||Log Rank|Log-rank test stratified by investigator's preferred platinum therapy, gender, and ECOG performance status.|The hazard ratio was obtained using the covariate adjusted Cox Proportional Hazard Model with covariates of ECOG performance status, investigators' preferred platinum therapy, and gender.|||1.080|0.388|0.260
72577175|NCT00696787|144680900|SUPERIORITY_OR_OTHER||Adjusted mean|-0.28||||0.604|TWO_SIDED|95.0|-1.33|0.77|||ANCOVA|||||0.77|-1.33|0.604
72492671|NCT02264990|144513975|OTHER||Odds Ratio (OR)|0.66||||0.455|TWO_SIDED|95.0|0.23|1.9|||Regression, Logistic|Logistic regression adjusted for the covariates of ECOG performance status, investigators' preferred platinum therapy, and gender.|Odds ratio is from covariate adjusted logistic regression with the covariates being ECOG performance status, investigators' preferred platinum therapy, and gender.|||1.90|0.23|0.455
72492672|NCT02264990|144513976|OTHER||Hazard Ratio (HR)|0.986||||0.846|TWO_SIDED|95.0|0.827|1.176|||Log Rank|Log rank test stratified by LSP status, ECOG performance status, investigators' preferred platinum therapy, and gender.|The hazard ratio was obtained using the covariate adjusted Cox Proportional Hazard Model with covariates of LSP status, ECOG performance status, investigators' preferred platinum therapy, and gender.|||1.176|0.827|0.846
72492673|NCT02264990|144513977|OTHER||Hazard Ratio (HR)|1.035||||0.473|TWO_SIDED|95.0|0.867|1.235|||Log Rank|Log rank test stratified by LSP status, ECOG performance status, investigators' preferred platinum therapy, and gender.|The hazard ratio was obtained using the covariate adjusted Cox Proportional Hazard Model with covariates of LSP status, ECOG performance status, investigators' preferred platinum therapy, and gender.|||1.235|0.867|0.473
72517947|NCT03589885|144565767|SUPERIORITY||Odds Ratio (OR)|88.46|||<|0.0001|TWO_SIDED|95.0|16.15|484.52|||Regression, Logistic|||||484.52|16.15|<0.0001
72517948|NCT03589885|144565767|SUPERIORITY||Odds Ratio (OR)|37.9|||<|0.0001|TWO_SIDED|95.0|7.6|189.01|||Regression, Logistic|||||189.01|7.60|<0.0001
72517949|NCT02555657|144565810|SUPERIORITY||Hazard Ratio (HR)|0.78||||0.0574|TWO_SIDED|95.0|0.57|1.06|||Regression, Cox|||||1.06|0.57|0.0574
72517950|NCT02555657|144565811|SUPERIORITY||Hazard Ratio (HR)|0.86||||0.0728|TWO_SIDED|95.0|0.69|1.06|||Regression, Cox|||||1.06|0.69|0.0728
72517951|NCT02555657|144565812|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.3802|TWO_SIDED|95.0|0.82|1.15|||Regression, Cox|||||1.15|0.82|0.3802
72517952|NCT02555657|144565813|SUPERIORITY||Difference in percentages|8.3||||0.0457|TWO_SIDED|95.0|-1.4|18.4|||Miettinen & Nurminen method|||||18.4|-1.4|0.0457
72517953|NCT02555657|144565814|SUPERIORITY||Difference in percentages|2.9||||0.1752|TWO_SIDED|95.0|-3.3|9.2|||Miettinen & Nurminen method|||||9.2|-3.3|0.1752
72517954|NCT02555657|144565815|SUPERIORITY||Difference in percentages|-1.0||||0.6629|TWO_SIDED|95.0|-5.9|3.8|||Miettinen & Nurminen method|||||3.8|-5.9|0.6629
72517955|NCT02555657|144565816|SUPERIORITY||Hazard Ratio (HR)|1.14||||0.7936|TWO_SIDED|95.0|0.82|1.59|||Regression, Cox|||||1.59|0.82|0.7936
72517956|NCT02555657|144565817|SUPERIORITY||Hazard Ratio (HR)|1.35||||0.9964|TWO_SIDED|95.0|1.08|1.68|||Regression, Cox|||||1.68|1.08|0.9964
72517957|NCT02555657|144565818|SUPERIORITY||Hazard Ratio (HR)|1.6||||1|TWO_SIDED|95.0|1.33|1.92|||Regression, Cox|||||1.92|1.33|1.0000
72517958|NCT02555657|144565822|SUPERIORITY||Difference in percentages|2.3||||0.3388|TWO_SIDED|95.0|-8.7|13.5|||Miettinen & Nurminen method|||||13.5|-8.7|0.3388
72517959|NCT02555657|144565823|SUPERIORITY||Difference in percentages|-1.6||||0.6701|TWO_SIDED|95.0|-8.6|5.5|||Miettinen & Nurminen method|||||5.5|-8.6|0.6701
72517960|NCT02555657|144565824|SUPERIORITY||Difference in percentages|-6.5||||0.9877|TWO_SIDED|95.0|-12.2|-0.8|||Miettinen & Nurminen method|||||-0.8|-12.2|0.9877
72517961|NCT00493974|144565827|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3876||95.0|||||Wilcoxon (Mann-Whitney)|||||||.3876
72517962|NCT00493974|144565828|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6413||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.6413
72517963|NCT00493974|144565829|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6433||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.6433
72517964|NCT00493974|144565830|SUPERIORITY_OR_OTHER_LEGACY|||||||0.63||95.0|||||Chi-squared|||||||0.63
72517965|NCT00493974|144565831|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4957||95.0|||||t-test, 2 sided|||||||0.4957
72492674|NCT02264990|144513978|OTHER||Odds Ratio (OR)|0.86||||0.409|TWO_SIDED|95.0|0.59|1.24|||Regression, Logistic|Logistic regression adjusted for the covariates of LSP status, ECOG performance status, investigators' preferred platinum therapy, and gender.|Odds ratio is from covariate adjusted logistic regression with the covariates being LSP status, ECOG performance status, investigators' preferred platinum therapy, and gender.|||1.24|0.59|0.409
72517966|NCT00493974|144565832|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||t-test, 2 sided|||||||<0.0001
72517967|NCT00493974|144565833|SUPERIORITY_OR_OTHER_LEGACY|||||||0.006||95.0|||||t-test, 2 sided|||||||0.006
72517968|NCT01861054|144565853|OTHER|||||||0.3149||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups|Wilcoxon (Mann-Whitney)|||Comparison on ALDH+ cells by ALDEFLUOR assay||||0.3149
72517969|NCT01861054|144565853|OTHER|||||||0.8148||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|Wilcoxon (Mann-Whitney)|||Comparison on CD44+/CD24- by flow citometry||||0.8148
72517970|NCT01861054|144565854|OTHER||||||>|0.9999|||||||Wilcoxon (Mann-Whitney)|||Phospho AKT Extent||||>0.9999
72517971|NCT01861054|144565854|OTHER||||||>|0.9999|||||||Wilcoxon (Mann-Whitney)|||Phospho-AKT Intensity||||>0.9999
72517972|NCT01861054|144565854|OTHER|||||||0.2245|||||||Wilcoxon (Mann-Whitney)|||AKT Extent||||0.2245
72517973|NCT01861054|144565854|OTHER|||||||0.5785|||||||Wilcoxon (Mann-Whitney)|||AKT Intensity||||0.5785
72517974|NCT01861054|144565854|OTHER||||||>|0.9999|||||||Wilcoxon (Mann-Whitney)|||Phospho-FAK Extent||||>0.9999
72517975|NCT01861054|144565854|OTHER|||||||0.3139|||||||Wilcoxon (Mann-Whitney)|||Phospho-FAK Intensity||||0.3139
72517976|NCT01861054|144565854|OTHER|||||||0.212|||||||Wilcoxon (Mann-Whitney)|||FAK Extent||||0.2120
72517977|NCT01861054|144565854|OTHER||||||>|0.9999|||||||Wilcoxon (Mann-Whitney)|||FAK Intensity||||>0.9999
72517978|NCT01861054|144565854|OTHER||||||>|0.9999|||||||Wilcoxon (Mann-Whitney)|||C-PTEN Extent||||>0.9999
72517979|NCT01861054|144565854|OTHER|||||||0.8728|||||||Wilcoxon (Mann-Whitney)|||C-PTEN Intensity||||0.8728
72517980|NCT01861054|144565854|OTHER||||||>|0.9999|||||||Wilcoxon (Mann-Whitney)|||D-PTEN Extent||||>0.9999
72517981|NCT01861054|144565854|OTHER|||||||0.8728|||||||Wilcoxon (Mann-Whitney)|||D-PTEN Intensity||||0.8728
72517982|NCT01861054|144565854|OTHER|||||||0.2265|||||||Wilcoxon (Mann-Whitney)|||CXCR1 Extent||||0.2265
72517983|NCT01861054|144565854|OTHER|||||||0.2403|||||||Wilcoxon (Mann-Whitney)|||CXCR1 Intensity||||0.2403
72577176|NCT00696787|144680901|SUPERIORITY_OR_OTHER||Adjusted mean|-0.35||||0.51|TWO_SIDED|95.0|-1.42|0.71|||ANCOVA|||||0.71|-1.42|0.510
72577177|NCT00696787|144680901|SUPERIORITY_OR_OTHER||Adjusted mean|-0.55||||0.317|TWO_SIDED|95.0|-1.64|0.54|||ANCOVA|||||0.54|-1.64|0.317
72569534|NCT02856880|144669964|SUPERIORITY_OR_OTHER||LS mean difference|-763.6||||0.2702|TWO_SIDED|95.0|-2144.45|617.25||Obtained from ANCOVA including period and treatment as fixed effects, participant as a random effect and participant-level pre-treatment values and period minus participant-level pre-treatment values as covariates in the model.|ANCOVA||Difference is first named treatment minus second named treatment such that a negative difference indicates a smaller live:dead stain ratio for the first named treatment.|||617.25|-2144.45|0.2702
72492675|NCT01849172|144513979|SUPERIORITY|||||||0.05|||||||Mixed Models Analysis|||||||0.05
72492676|NCT02112370|144514003|SUPERIORITY_OR_OTHER|||||||0.008||||||threshold p value for significance \< 0.05|t-test, 2 sided|||Swallowing difficulty||||0.008
72492677|NCT02112370|144514003|SUPERIORITY_OR_OTHER|||||||0.016||||||threshold p value for significance \< 0.05|t-test, 2 sided|||Anterior neck pain||||0.016
72492678|NCT02112370|144514003|SUPERIORITY_OR_OTHER|||||||0.019||||||threshold p value for significance \< 0.05|t-test, 2 sided|||Right chest pain||||0.019
72492679|NCT02112370|144514003|SUPERIORITY_OR_OTHER|||||||0.035||||||threshold p value for significance \< 0.05|t-test, 2 sided|||Left chest pain||||0.035
72517984|NCT01861054|144565855|OTHER||||||>|0.9999||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups|Wilcoxon (Mann-Whitney)|||Interleukin 1 Beta||||>0.9999
72517985|NCT01861054|144565855|OTHER|||||||0.6945||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups|Wilcoxon (Mann-Whitney)|||Interleukin 6||||0.6945
72517986|NCT01861054|144565855|OTHER|||||||0.9448||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|Wilcoxon (Mann-Whitney)|||Interleukin 8||||0.9448
72517987|NCT01861054|144565855|OTHER|||||||0.6292||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|Wilcoxon (Mann-Whitney)|||Tumor Necrosis Factor - alpha||||0.6292
72517988|NCT01861054|144565855|OTHER|||||||0.2354||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|Wilcoxon (Mann-Whitney)|||Granulocyte Macrophage Colony Stm Factor||||0.2354
72569535|NCT02856880|144669964|SUPERIORITY_OR_OTHER||LS mean difference|947.97||||0.1511|TWO_SIDED|95.0|-361.95|2257.9||Obtained from ANCOVA including period and treatment as fixed effects, participant as a random effect and participant-level pre-treatment values and period minus participant-level pre-treatment values as covariates in the model.|ANCOVA||Difference is first named treatment minus second named treatment such that a negative difference indicates a smaller live:dead stain ratio for the first named treatment.|||2257.90|-361.95|0.1511
72492680|NCT02112370|144514003|SUPERIORITY_OR_OTHER|||||||0.089||||||threshold p value for significance \< 0.05|t-test, 2 sided|||Back pain||||0.089
72492681|NCT02112370|144514003|SUPERIORITY_OR_OTHER|||||||0.634||||||threshold p value for significance \< 0.05|t-test, 2 sided|||Posterior neck pain||||0.634
72517989|NCT01861054|144565855|OTHER||||||>|0.9999||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|Wilcoxon (Mann-Whitney)|||Vascular Endothelial Growth Factor||||>0.9999
72517990|NCT01861054|144565855|OTHER|||||||0.4719||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|Wilcoxon (Mann-Whitney)|||Basic Fibroblast Growth Factor||||0.4719
72517991|NCT01861054|144565856|OTHER|||||||0.0951|||||||Wilcoxon (Mann-Whitney)|||CD31 Extent||||0.0951
72405328|NCT01077960|144318497|SUPERIORITY_OR_OTHER|||||||0.007||95.0|||||t-test, 2 sided|||||||0.007
72405329|NCT01077960|144318498|SUPERIORITY_OR_OTHER|||||||0.015||95.0|||||t-test, 2 sided|||||||0.015
72492682|NCT00689572|144514020|EQUIVALENCE|Mixed-effects linear regression model|Mean Difference (Final Values)|-0.09||||0.972|TWO_SIDED|95.0|-5.43|5.25|||Regression, Linear|Mixed-effects linear regression model included random intercept and slope (for temporal trend)||Difference between ondansetron and placebo groups regarding percentage of cocaine-free days (PCFD)||5.25|-5.43|0.972
72492683|NCT00689572|144514021|EQUIVALENCE|Mixed-effects linear regression model|Mean Difference (Final Values)|0.44||||0.909|TWO_SIDED|95.0|-7.08|7.95|||Regression, Linear|Mixed-effects linear regression model included random intercept and slope (for temporal trend)||Difference between ondansetron and placebo groups regarding percentage of cocaine free urines (PCFU)||7.95|-7.08|0.909
72492684|NCT03603496|144514036|SUPERIORITY||Risk Ratio (RR)|1.18||||0.19|TWO_SIDED|95.0|0.92|1.5|||Chi-squared||Comparing TTCM as numerator, QL as denominator (reference group)|Two-stage multiple imputation techniques were used to estimate the missing smoking outcomes. 1st stage: we imputed missing data from surveys. 2nd stage: we imputed missing data from biochemical sample collection. Null hypothesis was no difference between arms in biochemically-validated past 7-day abstinence from cigarettes and other conventional tobacco products at 6-months. Sample of 1350 (675/group) was planned to detect a 6.5% difference (23.0% vs. 16.5%) with 84% power and 2-sided p\<0.05.||1.50|0.92|.19
72492685|NCT03603496|144514037|SUPERIORITY||Risk Ratio (RR)|1.22||||0.002|TWO_SIDED|95.0|1.08|1.35|||Chi-squared||Numerator is TTCM, denominator (reference group) is QL|Multiple imputation techniques were used to estimate the missing smoking outcomes. The null hypothesis was no difference between study arms.||1.35|1.08|.002
72492686|NCT03603496|144514038|SUPERIORITY||Risk Ratio (RR)|1.23||||0.001|TWO_SIDED|95.0|1.09|1.37|||Chi-squared||Numerator is TTCM, denominator (reference group) is QL|Multiple imputation techniques were used to estimate the missing smoking outcomes. The null hypothesis was no difference between study arms.||1.37|1.09|.001
72492687|NCT03603496|144514039|SUPERIORITY||Risk Ratio (RR)|1.13||||0.079|TWO_SIDED|95.0|0.98|1.29|||Chi-squared||Numerator is TTCM, denominator (reference group) is QL|Multiple imputation techniques were used to estimate the missing smoking outcomes. The null hypothesis was no difference between study arms.||1.29|0.98|.079
72492688|NCT03603496|144514040|SUPERIORITY||Risk Ratio (RR)|1.32|||<|0.0001|TWO_SIDED|95.0|1.21|1.44|||Chi-squared|||Participants lost to follow-up or with missing data are counted as having received no treatment. The null hypothesis was no difference between study arms.||1.44|1.21|<.0001
72517992|NCT01861054|144565856|OTHER|||||||0.1643|||||||Wilcoxon (Mann-Whitney)|||CD31 Intensity||||0.1643
72517993|NCT01861054|144565857|OTHER|||||||0.4183|||||||Wilcoxon (Mann-Whitney)|||P62 Extent||||0.4183
72517994|NCT01861054|144565857|OTHER|||||||0.3702|||||||Wilcoxon (Mann-Whitney)|||P62 Intensity||||0.3702
72517995|NCT01861054|144565862|OTHER|||||||0.6168||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||Lymphocyte in WBC||||0.6168
72405330|NCT02540954|144318519|NON_INFERIORITY|Non-inferiority margin is 5 letters.|Least squares mean difference|0.22|||<|0.0001|TWO_SIDED|95.0|-1.51|1.96|||ANCOVA|||||1.96|-1.51|< 0.0001
72405331|NCT02540954|144318520|NON_INFERIORITY|Non inferiority margin is 7%.|Treatment difference in %|1.1|||||TWO_SIDED|95.0|-3.7|6.0||||||||6.0|-3.7|
72517996|NCT01861054|144565862|OTHER|||||||0.6168||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||Total T cell in lymphocytes||||0.6168
72517997|NCT01861054|144565862|OTHER|||||||0.1453||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||B cell in lymphocytes||||0.1453
72517998|NCT01861054|144565862|OTHER|||||||0.1453||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||T-helper cell in lymphocytes||||0.1453
72517999|NCT01861054|144565862|OTHER|||||||0.1453||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||CTL in lymphocytes||||0.1453
72518000|NCT01861054|144565862|OTHER||||||>|0.9999||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||NKT cell in lymphocytes||||>0.9999
72518001|NCT01861054|144565862|OTHER|||||||0.7634||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||ADCC NK subsets in lymphocytes||||0.7634
72518002|NCT01861054|144565862|OTHER|||||||0.5487||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||Regulatory NK subsets in lymphocytes||||0.5487
72518003|NCT01861054|144565862|OTHER||||||>|0.9999||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||Exhausted NK subsets in lymphocytes||||>0.9999
72518004|NCT01861054|144565862|OTHER||||||>|0.9999||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||CD56-CD16+ NK subsets in lymphocytes||||>0.9999
72518005|NCT01861054|144565862|OTHER|||||||0.1451||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||CD11b in PMNs - IL-8||||0.1451
72518006|NCT01861054|144565862|OTHER|||||||0.2779||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||CD18 in PMNs - IL-8||||0.2779
72518007|NCT01861054|144565862|OTHER|||||||0.1444||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||MFI of CD11b - IL-8||||0.1444
72518008|NCT01861054|144565862|OTHER|||||||0.1453||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||MFI of CD66b - IL-8||||0.1453
72624833|NCT00937105|144779048|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|5.22||||0.04|TWO_SIDED|95.0|1.1|24.7|||Regression, Cox|Multivariate model adjusted for solution, gender and age|referent is no substantial CNS lid bioburden|||24.70|1.10|0.04
72518009|NCT01861054|144565862|OTHER|||||||0.92||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||MFI of CD18 - IL-8||||0.9200
72624834|NCT00791648|144779084|SUPERIORITY_OR_OTHER_LEGACY|||||||0.75|||||||Pearson x2|||||||.75
72405332|NCT02540954|144318525|OTHER||Mean Difference (Final Values)|-1.88|||||TWO_SIDED|95.0|-4.152|0.392||||||||0.392|-4.152|
72405333|NCT00244712|144318560|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority of the ABC/3TC to the TDF/FTC would be declared if the lower limit of the 2-sided 95% confidence interval on the difference in the percentage of participants with HIV-1 RNA \<50 copies/mL at Week 48 \[ABC/3TC minus TDF/FTC\] was -12% or greater.|difference in response percentage|0.39||||0.913||95.0|-6.63|7.4|||Cochran-Mantel-Haenszel||Difference in response percentage = percentage in Arm 1 minus percentage in Arm 2|||7.40|-6.63|0.913
72405334|NCT00249470|144318574|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.8||||0.004|TWO_SIDED|95.0|2.03|16.56|||General Estimating Equation (GEE)|||||16.56|2.03|.004
72518010|NCT01861054|144565862|OTHER|||||||0.2779||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||CD11b in PMNs - US||||0.2779
72518011|NCT01861054|144565862|OTHER|||||||0.6164||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||CD18 in PMNs - US||||0.6164
72518012|NCT01861054|144565862|OTHER||||||>|0.9999||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||MFI of CD11b - US||||>0.9999
72518013|NCT01861054|144565862|OTHER|||||||0.2032||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||MFI of CD66b - US||||0.2032
72518014|NCT01861054|144565862|OTHER||||||>|0.9999||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||MFI of CD18 - US||||>0.9999
72518015|NCT01861054|144565862|OTHER|||||||0.525||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||Percent Monocytes expressing IL6 - IL-8||||0.5250
72518016|NCT01861054|144565862|OTHER|||||||0.6706||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||Percent Monocytes expressing IL1b - IL-8||||0.6706
72518017|NCT01861054|144565862|OTHER|||||||0.8312||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||Percent Monocytes expressing IL8 - IL-8||||0.8312
72518018|NCT01861054|144565862|OTHER|||||||0.3992||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||Percent Monocytes expressing TNFa - IL-8||||0.3992
72518019|NCT01861054|144565862|OTHER|||||||0.2952||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||Percent Neutrophils expressing IL6 - IL-8||||0.2952
72518020|NCT01861054|144565862|OTHER|||||||0.3992||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||Percent Neutrophils expressing IL1b - IL-8||||0.3992
72624835|NCT00791648|144779085|SUPERIORITY_OR_OTHER_LEGACY|||||||0.56|||||||Wilcoxon (Mann-Whitney)|||||||.56
72624836|NCT00791648|144779086|SUPERIORITY_OR_OTHER_LEGACY|||||||0.71|||||||Wilcoxon (Mann-Whitney)|||||||.71
72492689|NCT03603496|144514041|SUPERIORITY||Risk Ratio (RR)|1.35|||<|0.0001|TWO_SIDED|95.0|1.23|1.5|||Chi-squared|||Participants lost to follow-up or with missing data are counted as having received no treatment. The null hypothesis was no difference between study arms.||1.50|1.23|<.0001
72492690|NCT03603496|144514042|SUPERIORITY||Risk Ratio (RR)|1.31||||0.033|TWO_SIDED|95.0|1.02|1.66|||Chi-squared||Numerator is TTCM, denominator (reference group) is QL|Multiple imputation techniques were used to estimate the missing smoking outcomes. The null hypothesis was no difference between study arms.||1.66|1.02|.033
72492691|NCT00774345|144514043|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.276|TWO_SIDED|95.0|0.61|1.15||The p-value is based on a stratified log-rank test.|Log Rank||Based on the stratified cox proportional hazards model comparing the hazard functions associated with the treatment groups.|||1.15|0.61|0.276
72492692|NCT02342015|144514049|OTHER||||||<|0.05|||||||wilcoxon signed-rank test|||||||<0.05
72492693|NCT02342015|144514050|OTHER||||||<|0.05|||||||paired Student's t-test|||||||<0.05
72492694|NCT01692301|144514051|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.66|STANDARD_ERROR_OF_MEAN|1.42||0.01|TWO_SIDED|95.0|-6.45|-0.87|||ANCOVA|||||-0.87|-6.45|0.010
72492695|NCT01142726|144514062|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.01|STANDARD_ERROR_OF_MEAN|0.55||0.01|TWO_SIDED|95.0|1.18|3.43|||Regression, Logistic|Statistical testing of the 2 coprimary efficacy endpoints was conducted in a hierarchical fashion to maintain the overall Type I error rate at 5%.|At Month 12|Power estimate assumed 2-sided alpha level of 5% and that 60% of abatacept (ABA)+methotrexate (MX) patients (pts) would be in DAS28-CRP remission at Month 12 compared with 38% of MX monotherapy pts. Also assumed that 48% of ABA monotherapy pts would be in DAS28-CRP remission at Month 12, yielding an expected treatment difference from MX of 10% in favor of ABA monotherapy; 116 pts randomized to ABA monotherapy would yield a half-length of the 95% CI around that 10% treatment difference of 13.5%.||3.43|1.18|0.010
72492696|NCT01142726|144514062|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.51|STANDARD_ERROR_OF_MEAN|1.15||0.045|TWO_SIDED|95.0|1.02|6.18|||Regression, Logistic|Statistical testing of the 2 coprimary efficacy endpoints was conducted in a hierarchical fashion to maintain the overall Type I error rate at 5%.|At Months 12 and 18|Conditional on statistical significance of the 1st coprimary efficacy analysis (CEA), a sample of 116 patients per arm would provide 98% power for the 2nd CEA comparison of the percentage of patients in DAS28-CRP remission at Months 12 and 18 between the abatacept (ABA)+methotrexate (MTX) arm and the MTX monotherapy arm for intent-to treat population. This sample size calculation assumed 30% remission in the ABA+MTX arm and 8% in the monotherapy arm at Month 18 and a 2-sided alpha level of 5%.||6.18|1.02|0.045
72492697|NCT01142726|144514063|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.92|STANDARD_ERROR_OF_MEAN|0.25|||TWO_SIDED|95.0|0.55|1.57|||||At Month 12|||1.57|0.55|
72518021|NCT01861054|144565862|OTHER|||||||0.2952||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||Percent Neutrophils expressing IL8 - IL-8||||0.2952
72518022|NCT01861054|144565862|OTHER|||||||0.525||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||Percent Neutrophils expressing TNFa - IL-8||||0.5250
72624837|NCT00791648|144779087|SUPERIORITY_OR_OTHER_LEGACY|||||||0.11|||||||Wilcoxon (Mann-Whitney)|||||||.11
72492698|NCT01142726|144514063|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.04|STANDARD_ERROR_OF_MEAN|0.96|||TWO_SIDED|95.0|0.81|5.14|||||At Months 12 and 18|||5.14|0.81|
72492699|NCT02109484|144514086|EQUIVALENCE|Power to detect difference between treatment groups for seroresponse between 50% and 95% for P2-VP8 subunit rotiarivus vaccine calculated based on estimate of 10% loss. 45 evaluable participants in 2 highest doses tolerated in B1 infant cohort, study idesigned to provide \>= 89% and \>= 77% power to detect 35 and 30 percentage points difference, respectively, between the two dose levels and provide \> 95% to detect \>= 40 percentage point difference between a P2-VP8 dose group and placebo group.||||||0.0165|||||||Wilcoxon (Mann-Whitney)|||||||0.0165
72492700|NCT02109484|144514086|EQUIVALENCE|Power to detect difference between treatment groups for seroresponse between 50% and 95% for P2-VP8 subunit rotiarivus vaccine calculated based on estimate of 10% loss. 45 evaluable participants in 2 highest doses tolerated in B1 infant cohort, study idesigned to provide \>= 89% and \>= 77% power to detect 35 and 30 percentage points difference, respectively, between the two dose levels and provide \> 95% to detect \>= 40 percentage point difference between a P2-VP8 dose group and placebo group.|||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||Power to detect difference between treatment groups for seroresponse between 50% and 95% for P2-VP8 subunit rotiarivus vaccine calculated based on estimate of 10% loss. 45 evaluable participants in 2 highest doses tolerated in B1 infant cohort, study idesigned to provide \>= 89% and \>= 77% power to detect 35 and 30 percentage points difference, respectively, between the two dose levels and provide \> 95% to detect \>= 40 percentage point difference between a P2-VP8 dose group and placebo group.||||<0.0001
72492701|NCT02109484|144514086|EQUIVALENCE|Power to detect difference between treatment groups for seroresponse between 50% and 95% for P2-VP8 subunit rotiarivus vaccine calculated based on estimate of 10% loss. 45 evaluable participants in 2 highest doses tolerated in B1 infant cohort, study idesigned to provide \>= 89% and \>= 77% power to detect 35 and 30 percentage points difference, respectively, between the two dose levels and provide \> 95% to detect \>= 40 percentage point difference between a P2-VP8 dose group and placebo group.|||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
72492702|NCT02109484|144514087|OTHER||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||Pair-wise comparisons between Cohort B Placebo group and the active vaccination groups were peformed||||<0.0001
72492703|NCT02109484|144514087|EQUIVALENCE|Pair-wise comparisons between Cohort B Placebo group and the active vaccination groups were performed|||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
72492704|NCT02109484|144514087|EQUIVALENCE|Pair-wise comparisons between Cohort B Placebo group and the active vaccination groups were performed||||||0.0006|||||||Wilcoxon (Mann-Whitney)|||||||0.0006
72518023|NCT01861054|144565862|OTHER|||||||0.3992||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||Percent Monocytes expressing IL6 - US||||0.3992
72518024|NCT01861054|144565862|OTHER|||||||0.2952||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||Percent Monocytes expressing IL1b - US||||0.2952
72518025|NCT01861054|144565862|OTHER||||||>|0.9999||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||Percent Monocytes expressing IL8 - US||||>0.9999
72624838|NCT00791648|144779088|SUPERIORITY_OR_OTHER_LEGACY|||||||0.06|||||||Wilcoxon (Mann-Whitney)|||||||.06
72624839|NCT00791648|144779089|SUPERIORITY_OR_OTHER_LEGACY|||||||0.39|||||||Wilcoxon (Mann-Whitney)|||||||.39
72624840|NCT02947984|144779109|OTHER|||||||0.234|||||||Log Rank|||Null hypothesis: Progression free survival is not significantly different by dose level in the overall cohort.||||0.234
72624841|NCT02947984|144779109|OTHER|||||||0.82|||||||Log Rank|||Null hypothesis: Progression free survival is not significantly different by dose level in the subgroup receiving treatment due to a sub-total resection||||.820
72405335|NCT00249470|144318575|SUPERIORITY||Odds Ratio (OR)|0.91|||=|0.82|TWO_SIDED|95.0|0.4|2.08|||General Estimating Equation (GEE)|||||2.08|0.40|=0.82
72518026|NCT01861054|144565862|OTHER|||||||0.3992||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||Percent Monocytes expressing TNFa - US||||0.3992
72518027|NCT01861054|144565862|OTHER|||||||0.3992||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||Percent Neutrophils expressing IL6 - US||||0.3992
72518028|NCT01861054|144565862|OTHER|||||||0.2952||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||Percent Neutrophils expressing IL1b - US||||0.2952
72518029|NCT01861054|144565862|OTHER|||||||0.3992||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||Percent Neutrophils expressing IL8 - US||||0.3992
72518030|NCT01861054|144565862|OTHER|||||||0.2952||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||Percent Neutrophils expressing TNFa - US||||0.2952
72518031|NCT01861054|144565862|OTHER|||||||0.2238||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||Percent Monocytes expressing IL6 - LPS||||0.2238
72518032|NCT01861054|144565862|OTHER|||||||0.2238||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||Percent Monocytes expressing IL1b - LPS||||0.2238
72518033|NCT01861054|144565862|OTHER|||||||0.1543||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||Percent Monocytes expressing IL8 - LPS||||0.1543
72518034|NCT01861054|144565862|OTHER|||||||0.1547||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||Percent Monocytes expressing TNFa - LPS||||0.1547
72518035|NCT01861054|144565862|OTHER|||||||0.1547||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||Percent Neutrophils expressing IL6 - LPS||||0.1547
72518036|NCT01861054|144565862|OTHER|||||||0.1547||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||Percent Neutrophils expressing IL1b - LPS||||0.1547
72518037|NCT01861054|144565862|OTHER|||||||0.4314||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||Percent Neutrophils expressing IL8 - LPS||||0.4314
72624842|NCT02947984|144779109|OTHER|||||||0.061|||||||Log Rank|||Null hypothesis: Progression free survival is not significantly different by dose level in the sub-group receiving treatment due to recurrent disease||||.061
72405336|NCT00249470|144318576|SUPERIORITY||Odds Ratio (OR)|3.37||||0.04|TWO_SIDED|95.0|1.21|9.37|||General Estimating Equation (GEE)|||||9.37|1.21|0.04
72405337|NCT00500370|144318580|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Mixed Model Repeated Measures ANCOVA|||Analysis pertains to change at endpoint (Week 24)||||<0.0001
72405338|NCT00500370|144318581|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Mixed Model Repeated Measures ANCOVA|||Analysis pertains to change at endpoint (Week 24)||||<0.0001
72518038|NCT01861054|144565862|OTHER|||||||0.3153||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||Percent Neutrophils expressing TNFa - LPS||||0.3153
72518039|NCT01861054|144565862|OTHER|||||||0.47||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||Percent Monocytes expressing IL6 - LPS+IL-8||||0.4700
72518040|NCT01861054|144565862|OTHER|||||||0.1605||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||Percent Monocytes expressing IL1b - LPS+IL-8||||0.1605
72518041|NCT01861054|144565862|OTHER|||||||0.1605||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||Percent Monocytes expressing IL8 - LPS+IL-8||||0.1605
72518042|NCT01861054|144565862|OTHER|||||||0.1605||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||Percent Monocytes expressing TNFa - LPS+IL-8||||0.1605
72518043|NCT01861054|144565862|OTHER|||||||0.1547||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||Percent Neutrophils expressing IL6 - LPS+IL-8||||0.1547
72518044|NCT01861054|144565862|OTHER|||||||0.1547||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||Percent Neutrophils expressing IL1b - LPS+IL-8||||0.1547
72518045|NCT01861054|144565862|OTHER|||||||0.3153||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||Percent Neutrophils expressing IL8 - LPS+IL-8||||0.3153
72518046|NCT01861054|144565862|OTHER|||||||0.1543||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||Percent Neutrophils expressing TNFa - LPS+IL-8||||0.1543
72518047|NCT01861054|144565862|OTHER|||||||0.1601||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||Percent FITC eColi Control||||0.1601
72518048|NCT01861054|144565862|OTHER|||||||0.2368||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||Percent FITC eColi Test||||0.2368
72518049|NCT01861054|144565862|OTHER|||||||0.1605||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||Percent PMNs unstimulated||||0.1605
72624843|NCT00836706|144779123|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The pharmacokinetic parameters will be evaluated statistically by an analysis of variance (ANOVA) appropriate for the experimental design of this study.|Test/Ref Ratio of LS Means x 100|101.0||||||90.0|85.2|120.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||120|85.2|
72492705|NCT02109484|144514088|EQUIVALENCE|Power to detect difference between treatment groups for seroresponse between 50% and 95% for P2-VP8 subunit rotiarivus vaccine calculated based on estimate of 10% loss. 45 evaluable participants in 2 highest doses tolerated in B1 infant cohort, study idesigned to provide \>= 89% and \>= 77% power to detect 35 and 30 percentage points difference, respectively, between the two dose levels and provide \> 95% to detect \>= 40 percentage point difference between a P2-VP8 dose group and placebo group.||||||0.0004|||||||Wilcoxon (Mann-Whitney)|||A pair wise comparison between the Adjusted Seroresponses in the placebo group and the Group B 10 mcg P2-VP8 was performed.||||0.0004
72492706|NCT02109484|144514088|EQUIVALENCE|Power to detect difference between treatment groups for seroresponse between 50% and 95% for P2-VP8 subunit rotiarivus vaccine calculated based on estimate of 10% loss. 45 evaluable participants in 2 highest doses tolerated in B1 infant cohort, study idesigned to provide \>= 89% and \>= 77% power to detect 35 and 30 percentage points difference, respectively, between the two dose levels and provide \> 95% to detect \>= 40 percentage point difference between a P2-VP8 dose group and placebo group.|||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||A pair wise comparison between the Adjusted Seroresponses in the placebo group and the Cohort B 30 mcg P2-VP8 vaccine group was performed.||||<0.0001
72492707|NCT02109484|144514088|EQUIVALENCE|Power to detect difference between treatment groups for seroresponse between 50% and 95% for P2-VP8 subunit rotiarivus vaccine calculated based on estimate of 10% loss. 45 evaluable participants in 2 highest doses tolerated in B1 infant cohort, study idesigned to provide \>= 89% and \>= 77% power to detect 35 and 30 percentage points difference, respectively, between the two dose levels and provide \> 95% to detect \>= 40 percentage point difference between a P2-VP8 dose group and placebo group.|||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||A pair-wise comparison between the Adjusted Seroresponses in Cohort B Placebo group and the Cohort B P2-VP8 group was performed.||||<0.0001
72492708|NCT02111993|144514092|SUPERIORITY_OR_OTHER|||||||0.02||||||This p-value correlates to Δ4 hr cTnT|t-test, 2 sided|||||||0.02
72492709|NCT02111993|144514092|SUPERIORITY_OR_OTHER|||||||0.03||||||This p-value correlates to Δ8 hr cTnT.|t-test, 2 sided|||||||0.03
72518050|NCT01861054|144565862|OTHER|||||||0.47||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||Percent PMNs fMLP||||0.4700
72518051|NCT01861054|144565862|OTHER|||||||0.3392||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||Percent L-selectin unstimulated||||0.3392
72518052|NCT01861054|144565862|OTHER|||||||0.808||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||Percent L-selectin fMLP||||0.8080
72518053|NCT00599027|144565863|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001||95.0||||Endpoint after 28 days of treatment|ANCOVA|Overall treatment effect tested using F-test(alpha=0.05;two-sided). Diff between least square means of the 2 groups calculated with two-sided 95% C.I||||||0.001
72518054|NCT00405821|144565864|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.75|||<|0.05|TWO_SIDED|95.0|0.58|0.99||P-value was adjusted to include multiple looks at data including an interim efficacy review at 50% and 75% accrual of person-years on study|Regression, Cox|adjusted for baseline log10 viral load, baseline CD4 count, gender, and age||Intent-to-treat analysis used Cox proportional hazards (CPH) models, adjusting for baseline log10 viral load (VL), CD4 cell count, gender and age to assess the risk of disease progression||0.99|0.58|<0.05
72518055|NCT00405821|144565865|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.31|||<|0.05|TWO_SIDED|95.0|0.19|0.48||we included multiple GUD events per subject in the estimate of GUD incidence|rate ratio with 95% CI|||Null hypothesis is no difference by treatment arm in rate of GUD.||0.48|0.19|<0.05
72518056|NCT00405821|144565866|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.463||||0.05|TWO_SIDED|95.0|-0.731|-0.194|||t-test, 2 sided|||Null hypothesis is no difference in annual rate of change in log10 viral load by arm.||-0.194|-0.731|0.05
72518057|NCT00476996|144565870|SUPERIORITY||Weighted Difference|20.4|||<|0.0001|TWO_SIDED|95.0|12.8|27.9|||Cochran-Mantel-Haenszel|||At Week 24, analysis was stratified by region and baseline DMARD therapy||27.9|12.8|< 0.0001
72518058|NCT00476996|144565870|SUPERIORITY||Weighted Difference|25.2|||<|0.0001|TWO_SIDED|95.0|17.7|32.7|||Cochran-Mantel-Haenszel|||At Week 24, analysis was stratified by region and baseline DMARD therapy||32.7|17.7|< 0.0001
72624844|NCT00836706|144779124|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The pharmacokinetic parameters will be evaluated statistically by an analysis of variance (ANOVA) appropriate for the experimental design of this study.|Test/Ref Ratio of LS Means x 100|101.0||||||90.0|88.7|114.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||114|88.7|
72405339|NCT00500370|144318582|SUPERIORITY_OR_OTHER|||||||0.6766||95.0|||||Mixed Model Repeated Measures ANCOVA|||Analysis pertains to change at endpoint (Week 24)||||0.6766
72492710|NCT02111993|144514092|SUPERIORITY_OR_OTHER|||||||0.16||||||This p-value correlates to Δ20 hr cTnT|t-test, 2 sided|||||||0.16
72492711|NCT02111993|144514093|SUPERIORITY_OR_OTHER|||||||0.04||||||This p-value correlates to Δ4 hr cTnT|t-test, 2 sided|||||||0.04
72492712|NCT02111993|144514093|SUPERIORITY_OR_OTHER|||||||0.06||||||This p-value correlates to Δ8 hr cTnT|t-test, 2 sided|||||||0.06
72518059|NCT00476996|144565870|SUPERIORITY||Weighted Difference|29.1|||<|0.0001|TWO_SIDED|95.0|21.6|36.6|||Cochran-Mantel-Haenszel|||At Week 48, analysis was stratified by region and baseline DMARD therapy||36.6|21.6|< 0.0001
72518060|NCT00476996|144565870|SUPERIORITY||Weighted Difference|30.3|||<|0.0001|TWO_SIDED|95.0|22.8|37.7|||Cochran-Mantel-Haenszel|||At Week 48, analysis was stratified by region and baseline DMARD therapy||37.7|22.8|< 0.0001
72518061|NCT00476996|144565871|SUPERIORITY||Weighted Difference|2.1||||0.1885|TWO_SIDED|95.0|-1.0|5.2|||Cochran-Mantel-Haenszel|||Analysis was stratified by region and baseline DMARD therapy||5.2|-1.0|0.1885
72518062|NCT00476996|144565871|SUPERIORITY||Weighted Difference|3.6||||0.033|TWO_SIDED|95.0|0.3|6.8|||Cochran-Mantel-Haenszel|||Analysis was stratified by region and baseline DMARD therapy||6.8|0.3|0.0330
72518063|NCT00476996|144565872|SUPERIORITY||Weighted Difference|4.2||||0.0175|TWO_SIDED|95.0|0.7|7.6|||Cochran-Mantel-Haenszel|||At Week 24, analysis was stratified by region and baseline DMARD therapy||7.6|0.7|0.0175
72518064|NCT00476996|144565872|SUPERIORITY||Weighted Difference|4.3||||0.0134|TWO_SIDED|95.0|0.9|7.8|||Cochran-Mantel-Haenszel|||At Week 24, analysis was stratified by region and baseline DMARD therapy||7.8|0.9|0.0134
72518065|NCT00476996|144565872|SUPERIORITY||Weighted Difference|10.5|||<|0.0001|TWO_SIDED|95.0|6.2|14.8|||Cochran-Mantel-Haenszel|||At Week 48, analysis was stratified by region and baseline DMARD therapy||14.8|6.2|< 0.0001
72405340|NCT00500370|144318583|SUPERIORITY_OR_OTHER|||||||0.0393||95.0|||||Cochran-Mantel-Haenszel|||||||0.0393
72492713|NCT02111993|144514093|SUPERIORITY_OR_OTHER|||||||0.16||||||This p-value correlates to Δ20 hr cTnT|t-test, 2 sided|||||||0.16
72492714|NCT02111993|144514094|SUPERIORITY_OR_OTHER|||||||0.17||||||This p-value correlates to Δ4 hr cTnT|t-test, 2 sided|||||||0.17
72492715|NCT02111993|144514094|SUPERIORITY_OR_OTHER|||||||0.19||||||This p-value correlates to Δ8 hr cTnT|t-test, 2 sided|||||||0.19
72492716|NCT02111993|144514094|SUPERIORITY_OR_OTHER|||||||0.38||||||This p-value correlates to Δ20 hr cTnT|t-test, 2 sided|||||||0.38
72492717|NCT04074928|144514095|NON_INFERIORITY|The non-inferiority criterion was that the upper limit of the 2-sided 95% CI did not exceed the prespecified non-inferiority margin of 1.5 for the Day 29/57 GMT ratio (adjusted analysis).|GMT ratio|0.73|||||TWO_SIDED|95.0|0.645|0.836||||||"Non-inferiority, A/H1N1, GMT ratio, Day 29/57~Non-inferiority of the Day 29/57 immune response to the A/H1N1 vaccine strain calculated by GMT ratio (Comparator QIV GMT divided by QIVc GMT)"||0.836|0.645|
72518066|NCT00476996|144565872|SUPERIORITY||Weighted Difference|10.5|||<|0.0001|TWO_SIDED|95.0|6.2|14.7|||Cochran-Mantel-Haenszel|||At Week 48, analysis was stratified by region and baseline DMARD therapy||14.7|6.2|< 0.0001
72518067|NCT00476996|144565873|SUPERIORITY||Adjusted Mean Difference|-0.6|||<|0.0001|TWO_SIDED|95.0|-0.8|-0.3|||Analysis of Variance|||Week 24 analysis using adjusted mean difference. Model contains region, baseline DMARD therapy, baseline DAS28 score and treatment||-0.3|-0.8|< 0.0001
72518068|NCT00476996|144565873|SUPERIORITY||Adjusted Mean Difference|-0.9|||<|0.0001|TWO_SIDED|95.0|-1.1|-0.6|||Analysis of Variance|||Week 24 analysis using adjusted mean difference. Model contains region, baseline DMARD therapy, baseline DAS28 score and treatment||-0.6|-1.1|< 0.0001
72518069|NCT00476996|144565873|SUPERIORITY||Adjusted Mean Difference|-0.9|||<|0.0001|TWO_SIDED|95.0|-1.2|-0.7|||Analysis of Variance|||Week 48 analysis using adjusted mean difference. Model contains region, baseline DMARD therapy, baseline DAS28 score and treatment||-0.7|-1.2|< 0.0001
72518070|NCT00476996|144565873|SUPERIORITY||Adjusted Mean Difference|-1.2|||<|0.0001|TWO_SIDED|95.0|-1.5|-0.9|||Analysis of Variance|||Week 48 analysis using adjusted mean difference. Model contains region, baseline DMARD therapy, baseline DAS28 score and treatment||-0.9|-1.5|< 0.0001
72518071|NCT00476996|144565874|SUPERIORITY||Odds Ratio (OR)|2.6|||<|0.0001|TWO_SIDED|95.0|1.85|3.66|||Proportional Odds Analysis|||At Week 24, analysis was stratified by region and baseline DMARD therapy||3.66|1.85|< 0.0001
72518072|NCT00476996|144565874|SUPERIORITY||Odds Ratio (OR)|3.49|||<|0.0001|TWO_SIDED|95.0|2.49|4.91|||Proportional Odds Analysis|||At Week 24, analysis was stratified by region and baseline DMARD therapy||4.91|2.49|< 0.0001
72518073|NCT00476996|144565874|SUPERIORITY||Odds Ratio (OR)|4.18|||<|0.0001|TWO_SIDED|95.0|2.93|5.96|||Proportional Odds Analysis|||At Week 48, analysis was stratified by region and baseline DMARD therapy||5.96|2.93|< 0.0001
72405341|NCT00500370|144318584|SUPERIORITY_OR_OTHER|||||||0.1808||95.0|||||ANCOVA|||Analysis pertains to change at endpoint (Week 24)||||0.1808
72405342|NCT00500370|144318585|SUPERIORITY_OR_OTHER|||||||0.1204||95.0|||||ANCOVA|||Analysis pertains to change at endpoint (Week 24)||||0.1204
72405343|NCT00500370|144318586|SUPERIORITY_OR_OTHER|||||||0.6651||95.0|||||ANCOVA|||||||0.6651
72492718|NCT04074928|144514095|NON_INFERIORITY|The non-inferiority criterion was that the upper limit of the 2-sided 95% CI did not exceed the prespecified non-inferiority margin of 1.5 for the Day 29/57 GMT ratio (adjusted analysis).|GMT ratio|0.73|||||TWO_SIDED|95.0|0.656|0.809||||||"Non-inferiority, B/Yamagata, GMT ratio, Day 29/57~Non-inferiority of the Day 29/57 immune response to the B/Yamagata vaccine strain calculated by GMT ratio (Comparator QIV GMT divided by QIVc GMT)"||0.809|0.656|
72492719|NCT04074928|144514095|NON_INFERIORITY|The non-inferiority criterion was that the upper limit of the 2-sided 95% CI did not exceed the prespecified non-inferiority margin of 1.5 for the Day 29/57 GMT ratio (adjusted analysis).|GMT ratio|0.88|||||TWO_SIDED|95.0|0.791|0.972||||||"Non-inferiority, B/Victoria, GMT ratio, Day 29/57~Non-inferiority of the Day 29/57 immune response to the B/Victoria vaccine strain calculated by GMT ratio (Comparator QIV GMT divided by QIVc GMT)"||0.972|0.791|
72492720|NCT04074928|144514096|NON_INFERIORITY|The non-inferiority criterion was that the upper limit of the 2-sided 95% CI did not exceed the prespecified non-inferiority margin of 10% for the Day 29/57 SCR difference.|SCR difference|-11.46|||||TWO_SIDED|95.0|-16.447|-6.423||||||"Non-inferiority, A/H1N1, SCR difference, Day 29/57~Non-inferiority of the immune response to the A/H1N1 vaccine strain by SCR difference (Comparator QIV SCR minus QIVc SCR)"||-6.423|-16.447|
72492721|NCT04074928|144514096|NON_INFERIORITY|The non-inferiority criterion was that the upper limit of the 2-sided 95% CI did not exceed the prespecified non-inferiority margin of 10% for the Day 29/57 SCR difference.|SCR difference|-14.87|||||TWO_SIDED|95.0|-19.61|-9.983||||||"Non-inferiority, B/Yamagata, SCR difference, Day 29/57~Non-inferiority of the immune response to the B/Yamagata vaccine strain by SCR difference (Comparator QIV SCR minus QIVc SCR)"||-9.983|-19.610|
72518074|NCT00476996|144565874|SUPERIORITY||Odds Ratio (OR)|5.04|||<|0.0001|TWO_SIDED|95.0|3.54|7.18|||Proportional Odds Analysis|||At Week 48, analysis was stratified by region and baseline DMARD therapy||7.18|3.54|< 0.0001
72518075|NCT00476996|144565875|SUPERIORITY||Weighted Difference|13.2|||<|0.0001|TWO_SIDED|95.0|7.4|19.1|||Cochran-Mantel-Haenszel|||At Week 24, analysis was stratified by region and baseline DMARD therapy||19.1|7.4|< 0.0001
72518076|NCT00476996|144565875|SUPERIORITY||Weighted Difference|16.2|||<|0.0001|TWO_SIDED|95.0|10.2|22.1|||Cochran-Mantel-Haenszel|||At Week 24, analysis was stratified by region and baseline DMARD therapy||22.1|10.2|< 0.0001
72518077|NCT00476996|144565875|SUPERIORITY||Weighted Difference|19.3|||<|0.0001|TWO_SIDED|95.0|12.9|25.6|||Cochran-Mantel-Haenszel|||At Week 48, analysis was stratified by region and baseline DMARD therapy||25.6|12.9|< 0.0001
72518078|NCT00476996|144565875|SUPERIORITY||Weighted Difference|20.8|||<|0.0001|TWO_SIDED|95.0|14.5|27.1|||Cochran-Mantel-Haenszel|||At Week 48, analysis was stratified by region and baseline DMARD therapy||27.1|14.5|< 0.0001
72518079|NCT00476996|144565876|SUPERIORITY||Weighted Difference|4.6||||0.0203|TWO_SIDED|95.0|0.7|8.5|||Cochran-Mantel-Haenszel|||At Week 24, analysis was stratified by region and baseline DMARD therapy||8.5|0.7|0.0203
72518080|NCT00476996|144565876|SUPERIORITY||Weighted Difference|6.7||||0.0014|TWO_SIDED|95.0|2.6|10.8|||Cochran-Mantel-Haenszel|||At Week 24, analysis was stratified by region and baseline DMARD therapy||10.8|2.6|0.0014
72518081|NCT00476996|144565876|SUPERIORITY||Weighted Difference|6.6||||0.0042|TWO_SIDED|95.0|2.1|11.2|||Cochran-Mantel-Haenszel|||At Week 48, analysis was stratified by region and baseline DMARD therapy||11.2|2.1|0.0042
72518082|NCT00476996|144565876|SUPERIORITY||Weighted Difference|13.4|||<|0.0001|TWO_SIDED|95.0|8.2|18.6|||Cochran-Mantel-Haenszel|||At Week 48, analysis was stratified by region and baseline DMARD therapy||18.6|8.2|< 0.0001
72518083|NCT00476996|144565877|SUPERIORITY||Weighted Difference|19.4|||<|0.0001|TWO_SIDED|95.0|11.3|27.5|||Cochran-Mantel-Haenszel|||At Week 24, analysis was stratified by region and baseline DMARD therapy||27.5|11.3|< 0.0001
72518084|NCT00476996|144565877|SUPERIORITY||Weighted Difference|24.7|||<|0.0001|TWO_SIDED|95.0|16.8|32.7|||Cochran-Mantel-Haenszel|||At Week 24, analysis was stratified by region and baseline DMARD therapy||32.7|16.8|< 0.0001
72518085|NCT00476996|144565877|SUPERIORITY||Weighted Difference|27.2|||<|0.0001|TWO_SIDED|95.0|19.5|34.9|||Cochran-Mantel-Haenszel|||At Week 48, analysis was stratified by region and baseline DMARD therapy||34.9|19.5|< 0.0001
72518086|NCT00476996|144565877|SUPERIORITY||Weighted Difference|27.6|||<|0.0001|TWO_SIDED|95.0|20.0|35.3|||Cochran-Mantel-Haenszel|||At Week 48, analysis was stratified by region and baseline DMARD therapy||35.3|20.0|< 0.0001
72518087|NCT00595868|144565895|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.7||||0.06|TWO_SIDED|95.0|1.0|2.9|||Chi-squared|||||2.9|1.0|0.06
72518088|NCT00595868|144565896|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.1||||0.1|TWO_SIDED|95.0|0.9|5.2|||Chi-squared|||||5.2|0.9|0.10
72518089|NCT04268303|144565901|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||||||<0.0001
72518090|NCT04268303|144565901|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||||||<0.0001
72518091|NCT04268303|144565902|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||180 Micrograms versus placebo; 90 minutes post-dose||||<0.0001
72518092|NCT04268303|144565902|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||120 Micrograms versus placebo; 90 minutes post-dose||||<0.0001
72518093|NCT04268303|144565902|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||180 Micrograms versus placebo; 60 minutes post-dose||||<0.0001
72518094|NCT04268303|144565902|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||120 Micrograms versus placebo; 60 minutes post-dose||||<0.0001
72518095|NCT04268303|144565902|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||180 Micrograms versus placebo; 45 minutes post-dose||||<0.0001
72405344|NCT00500370|144318587|SUPERIORITY_OR_OTHER|||||||0.1204||95.0|||||ANCOVA|||Analysis pertains to change at endpoint (Week 24)||||0.1204
72518096|NCT04268303|144565902|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||120 Micrograms versus placebo; 45 minutes post-dose||||<0.0001
72518097|NCT04268303|144565902|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||180 Micrograms versus placebo; 30 minutes post-dose||||<0.0001
72518098|NCT04268303|144565902|SUPERIORITY|||||||0.0075|||||||Mixed Models Analysis|||120 Micrograms versus placebo; 30 minutes post-dose||||0.0075
72518099|NCT04268303|144565902|SUPERIORITY|||||||0.0032|||||||Mixed Models Analysis|||180 Micrograms versus placebo; 20 minutes post-dose||||0.0032
72518100|NCT04268303|144565902|SUPERIORITY|||||||0.4097|||||||Mixed Models Analysis|||120 Micrograms versus placebo; 20 minutes post-dose||||0.4097
72518101|NCT04268303|144565902|SUPERIORITY|||||||0.0457|||||||Mixed Models Analysis|||180 Micrograms versus placebo; 10 minutes post-dose||||0.0457
72518102|NCT04268303|144565902|SUPERIORITY|||||||0.972|||||||Mixed Models Analysis|||120 Micrograms versus placebo; 10 minutes post-dose||||0.9720
72518103|NCT00223652|144565960|SUPERIORITY_OR_OTHER||||||=|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||=.001
72518104|NCT00223652|144565960|SUPERIORITY_OR_OTHER|||||||0.07|TWO_SIDED||||||Mixed Models Analysis|||||||0.07
72518105|NCT00223652|144565960|SUPERIORITY_OR_OTHER|||||||0.95|TWO_SIDED||||||Mixed Models Analysis|||||||0.95
72518106|NCT00223652|144565961|SUPERIORITY_OR_OTHER||||||>|0.37|TWO_SIDED||||||Mixed Models Analysis|||||||>0.37
72518107|NCT00223652|144565962|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Mixed Models Analysis|||||||<.0001
72518108|NCT00223652|144565962|SUPERIORITY_OR_OTHER|||||||0.61|TWO_SIDED||||||Mixed Models Analysis|||||||0.61
72518109|NCT00223652|144565962|SUPERIORITY_OR_OTHER|||||||0.2|TWO_SIDED||||||Mixed Models Analysis|||||||0.20
72518110|NCT00223652|144565963|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Generalized estimating equations models|||||||<0.0001
72518111|NCT00223652|144565963|SUPERIORITY_OR_OTHER|||||||0.12|TWO_SIDED||||||Generalized estimating equations models|||||||0.12
72518112|NCT00223652|144565963|SUPERIORITY_OR_OTHER|||||||0.86|TWO_SIDED||||||Generalized estimating equations models|||||||0.86
72518113|NCT00223652|144565964|SUPERIORITY_OR_OTHER||||||>|0.37|TWO_SIDED||||||Mixed Models Analysis|||||||>0.37
72518114|NCT00223652|144565965|SUPERIORITY_OR_OTHER||||||>|0.37|TWO_SIDED||||||Generalized estimating equations models|||||||>0.37
72518115|NCT00877006|144565980|SUPERIORITY_OR_OTHER|||||||0.0005||||||P-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment group, region, preassigned standard treatment, and lymphoma type as factors and baseline value as the covariate.|ANCOVA|||The hypothesis of interest is superiority of BR over standard treatment.||||0.0005
72518116|NCT00877006|144565981|SUPERIORITY||Hazard Ratio (HR)|0.99||||0.9677|TWO_SIDED|95.0|0.58|1.68|||Log Rank|Stratified log-rank test by preassigned standard treatment and lymphoma type.|BR/RCHOP-RCVP|||1.68|0.58|0.9677
72518117|NCT01878097|144566040|SUPERIORITY||F-stat|7.12||||0.0003|TWO_SIDED||||||Mixed Models Analysis|||||||0.0003
72518118|NCT01878097|144566041|SUPERIORITY||F-stat|7.18||||0.0003|TWO_SIDED||||||Mixed Models Analysis|||||||0.0003
72518119|NCT03325556|144566046|SUPERIORITY||Hazard Ratio (HR)|0.353|STANDARD_ERROR_OF_MEAN|0.3676||0.0023|TWO_SIDED|95.0|0.172|0.727||1-sided p-value reported. The protocol-defined O'Brien Flemming stopping boundary for the planned IA was a 1-sided p-value equal to 0.0033|Regression, Cox||Model included covariates for Treatment group, dementia subtype, and region, and robust sandwich-type variance estimator.|||0.727|0.172|0.0023
72518120|NCT03325556|144566047|SUPERIORITY||Hazard Ratio (HR)|0.452|STANDARD_ERROR_OF_MEAN|0.2812||0.0024|TWO_SIDED|95.0|0.261|0.785||1-sided p-value|Regression, Cox||Model included covariates for Treatment group, dementia subtype, and region, and robust sandwich-type variance estimator.|||0.785|0.261|0.0024
72518121|NCT02119026|144566048|SUPERIORITY|||||||0.967|||||||Mantel Haenszel|||||||0.967
72492722|NCT04074928|144514096|NON_INFERIORITY|The non-inferiority criterion was that the upper limit of the 2-sided 95% CI did not exceed the prespecified non-inferiority margin of 10% for the Day 29/57 SCR difference.|SCR difference|-5.96|||||TWO_SIDED|95.0|-10.327|-1.44||||||"Non-inferiority, B/Victoria, SCR difference, Day 29/57~Non-inferiority of the immune response to the B/Victoria vaccine strain by SCR difference (Comparator QIV SCR minus QIVc SCR)"||-1.440|-10.327|
72492723|NCT04074928|144514097|NON_INFERIORITY|The noninferiority criterion was that the upper limit of the 2-sided 95% CI did not exceed the prespecified noninferiority margin of 1.5 for the Day 29/57 GMT ratio (adjusted analysis).|GMT ratio|1.04|||||TWO_SIDED|95.0|0.927|1.16||||||"Non-inferiority, A/H3N2, GMT ratio, Day 29/57~Non-inferiority of the Day 29/57 immune response to the A/H3N2 vaccine strain calculated by GMT ratio (Comparator QIV GMT divided by QIVc GMT)"||1.160|0.927|
72492724|NCT04074928|144514098|NON_INFERIORITY|The non-inferiority criterion was that the upper limit of the 2-sided 95% CI did not exceed the prespecified non-inferiority margin of 10% for the Day 29/57 SCR difference.|SCR difference|3.13|||||TWO_SIDED|95.0|-1.443|7.812||||||"Non-inferiority, A/H3N2, SCR difference, Day 29/57~Non-inferiority of the immune response to the A/H3N2 vaccine strain by SCR difference (Comparator QIV SCR minus QIVc SCR)"||7.812|-1.443|
72492725|NCT04074928|144514099|OTHER|No formal statistical testing was planned for this secondary outcome measure.|GMT ratio|0.9|||||TWO_SIDED|95.0|0.79|1.024||||||A/H1N1, GMT ratio, Day 29/57||1.024|0.790|
72492726|NCT04074928|144514099|OTHER|No formal statistical testing was planned for this secondary outcome measure.|GMT ratio|1.08|||||TWO_SIDED|95.0|0.968|1.195||||||B/Yamagata, GMT ratio, Day 29/57||1.195|0.968|
72492727|NCT04074928|144514099|OTHER|No formal statistical testing was planned for this secondary outcome measure.|GMT ratio|1.09|||||TWO_SIDED|95.0|0.986|1.202||||||B/Victoria, GMT ratio, Day 29/57||1.202|0.986|
72492728|NCT04074928|144514100|OTHER|No formal statistical testing was planned for this secondary outcome measure.|SCR difference|-2.52|||||TWO_SIDED|95.0|-7.526|2.461||||||A/H1N1, SCR difference, Day 29/57||2.461|-7.526|
72518122|NCT02119026|144566049|SUPERIORITY|||||||0.474|||||||Mantel Haenszel|||||||0.474
72518123|NCT02119026|144566050|SUPERIORITY|||||||0.464|||||||Mantel Haenszel|||||||0.464
72518124|NCT02119026|144566051|SUPERIORITY|||||||0.854|||||||Fisher Exact|||||||0.854
72518125|NCT02119026|144566052|SUPERIORITY|||||||0.728|||||||Mantel Haenszel|||||||0.728
72518126|NCT02119026|144566053|SUPERIORITY|||||||0.668|||||||Mantel Haenszel|||||||0.668
72518127|NCT02119026|144566054|SUPERIORITY|||||||0.618|||||||Mantel Haenszel|||||||0.618
72624845|NCT00836706|144779125|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The pharmacokinetic parameters will be evaluated statistically by an analysis of variance (ANOVA) appropriate for the experimental design of this study.|Test/Ref Ratio of LS Means x 100|101.0||||||90.0|88.4|114.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||114|88.4|
72405345|NCT00500370|144318588|SUPERIORITY_OR_OTHER|||||||0.8479||95.0|||||Mixed Model Repeated Measures ANCOVA|||Analysis pertains to change at endpoint (Week 24)||||0.8479
72492729|NCT04074928|144514100|OTHER|No formal statistical testing was planned for this secondary outcome measure.|SCR difference|-0.04|||||TWO_SIDED|95.0|-4.912|4.911||||||B/Yamagata, SCR difference, Day 29/57||4.911|-4.912|
72492730|NCT04074928|144514100|OTHER|No formal statistical testing was planned for this secondary outcome measure.|SCR difference|1.18|||||TWO_SIDED|95.0|-2.805|5.353||||||B/Victoria, SCR difference, Day 29/57||5.353|-2.805|
72492731|NCT04074928|144514101|OTHER|No formal statistical testing was planned for this secondary outcome measure.|GMT ratio|1.03|||||TWO_SIDED|95.0|0.914|1.165||||||A/H3N2, GMT ratio, Day 29/57||1.165|0.914|
72492732|NCT04074928|144514102|OTHER|No formal statistical testing was planned for this secondary outcome measure.|SCR difference|1.89|||||TWO_SIDED|95.0|-3.006|6.856||||||A/H3N2, SCR difference, Day 29/57||6.856|-3.006|
72492733|NCT02685709|144514109|NON_INFERIORITY|An assessment of NI was made by comparing the lower bound of the two-sided 95% confidence interval (CI) for the difference in biochemical control (octreotide capsules - SRLs) to a NI margin of -20%.|95% CI Stratified Miettinen & Nurminen|-19.9|||||TWO_SIDED|95.0|-19.9|0.5|||Stratified Miettinen & Nurminen (M&N)|||||0.5|-19.9|
72492734|NCT02685709|144514110|OTHER|||||||||||||||||"Secondary endpoints were analyzed without adjustment for multiplicity or predefined noninferiority margins and therefore were interpreted as exploratory.~This endpoint is descriptive with no formal statistical hypothesis testing."|The statistical analysis was based on the stratified Miettinen \& Nurminen (M\&N) method.|||
72518128|NCT02119026|144566055|SUPERIORITY|||||||0.792||||||The rate of overall response was measured as the response rate from randomization until the day of documented complete response (CR) or partial response (PR) (whichever status is recorded first). Analysis corresponds to numbers of CR and PR.|Wilcoxon (Mann-Whitney)|||||||0.792
72518129|NCT02119026|144566056|SUPERIORITY|||||||0.371||||||The rate of overall response was measured as the response rate from randomization until the day of documented complete response (CR) or partial response (PR) (whichever status is recorded first). Analysis corresponds to numbers of CR and PR.|Wilcoxon (Mann-Whitney)|||||||0.371
72518130|NCT01226706|144566096|SUPERIORITY_OR_OTHER|||||||0.016|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|A Bonferroni correction (0.05/n) was used for multiple comparisons||"A sample of 16 subjects per group was required to detect a mean difference of 50 mL in maximum capacity at cystoscopy between botulinum toxin and placebo at 90% power with a two-sided type I error of 5%.~Difference scores were computed for the primary outcome, which were then compared using the Wilcoxon- Mann-Whitney U test. This type of analysis was used to identify both between group differences and within group differences (over time) while using non-parametric statistics."||||.016
72518131|NCT01226706|144566097|SUPERIORITY_OR_OTHER|||||||0.152|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|A Bonferroni correction (0.05/n) was used for multiple comparisons||||||0.152
72518132|NCT01226706|144566098|SUPERIORITY_OR_OTHER|||||||0.095|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|A Bonferroni correction (0.05/n) was used for multiple comparisons||||||0.095
72518133|NCT01226706|144566099|SUPERIORITY_OR_OTHER|||||||0.067|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|A Bonferroni correction (0.05/n) was used for multiple comparisons||||||0.067
72518134|NCT01226706|144566103|SUPERIORITY_OR_OTHER|||||||0.038|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|A Bonferroni correction (0.05/n) was used for multiple comparisons||||||0.038
72518135|NCT01226706|144566104|SUPERIORITY_OR_OTHER|||||||0.095|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|A Bonferroni correction (0.05/n) was used for multiple comparisons||||||0.095
72405346|NCT00500370|144318589|SUPERIORITY_OR_OTHER|||||||0.2151||95.0|||||ANCOVA|||Analysis pertains to change at endpoint (Week 24)||||0.2151
72405347|NCT00500370|144318590|SUPERIORITY_OR_OTHER|||||||0.7619||95.0|||||ANCOVA|||||||0.7619
72405348|NCT00500370|144318591|SUPERIORITY_OR_OTHER|||||||0.8973||95.0|||||ANCOVA|||||||0.8973
72518136|NCT01226706|144566105|SUPERIORITY_OR_OTHER|||||||0.038|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|A Bonferroni correction (0.05/n) was used for multiple comparisons||||||0.038
72518137|NCT01226706|144566109|SUPERIORITY_OR_OTHER|||||||0.904|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|A Bonferroni correction (0.05/n) was used for multiple comparisons||||||0.904
72518138|NCT01226706|144566110|SUPERIORITY_OR_OTHER|||||||0.08|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|A Bonferroni correction (0.05/n) was used for multiple comparisons||||||0.080
72518139|NCT01226706|144566111|SUPERIORITY_OR_OTHER|||||||0.23|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|A Bonferroni correction (0.05/n) was used for multiple comparisons||||||0.230
72518140|NCT01226706|144566115|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.1||||0.021|TWO_SIDED|95.0|-2.1|-0.2|||Wilcoxon (Mann-Whitney)|A Bonferroni correction (0.05/n) was used for multiple comparisons||||-0.2|-2.1|0.021
72518141|NCT01226706|144566116|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.3||||0.007|TWO_SIDED|95.0|-2.1|-0.5|||Wilcoxon (Mann-Whitney)|A Bonferroni correction (0.05/n) was used for multiple comparisons||||-0.5|-2.1|0.007
72518142|NCT01226706|144566117|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.2||||0.013|TWO_SIDED|95.0|-2.0|-0.4|||Wilcoxon (Mann-Whitney)|A Bonferroni correction (0.05/n) was used for multiple comparisons||||-0.4|-2.0|0.013
72518143|NCT01226706|144566118|SUPERIORITY_OR_OTHER|||||||0.173|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|A Bonferroni correction (0.05/n) was used for multiple comparisons||||||0.173
72518144|NCT01226706|144566119|SUPERIORITY_OR_OTHER|||||||0.051|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|A Bonferroni correction (0.05/n) was used for multiple comparisons||||||0.051
72624846|NCT01139515|144779127|SUPERIORITY_OR_OTHER_LEGACY||Adjusted ratio of geometric means|98.7|||||TWO_SIDED|90.0|92.17|105.7||||||Natural log transformed, dose-normalized AUC\[0- ∞\] of eletriptan was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||105.70|92.17|
72518145|NCT01226706|144566120|SUPERIORITY_OR_OTHER|||||||0.051|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|A Bonferroni correction (0.05/n) was used for multiple comparisons||||||0.051
72518146|NCT01226706|144566121|SUPERIORITY_OR_OTHER|||||||0.557|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|A Bonferroni correction (0.05/n) was used for multiple comparisons||||||0.557
72405349|NCT00500370|144318592|SUPERIORITY_OR_OTHER|||||||0.6507||95.0|||||Cochran-Mantel-Haenszel|||||||0.6507
72405350|NCT00500370|144318593|SUPERIORITY_OR_OTHER|||||||0.2593||95.0|||||Cochran-Mantel-Haenszel|||||||0.2593
72405351|NCT00500370|144318594|SUPERIORITY_OR_OTHER|||||||0.2919||95.0|||||Mixed Model Repeated Measures ANCOVA|||Analysis pertains to change at endpoint (Week 24)||||0.2919
72405352|NCT00500370|144318595|SUPERIORITY_OR_OTHER|||||||0.0293||95.0|||||Mixed Model Repeated Measures ANCOVA|||Analysis pertains to change at endpoint (Week 24)||||0.0293
72405353|NCT04976530|144318596|SUPERIORITY||win ratio|1.07||||0.748|TWO_SIDED|95.0|0.72|1.58|||Finkelstein Schoenfeld test|||||1.58|0.72|0.748
72405354|NCT04976530|144318597|SUPERIORITY||win ratio|1.33||||0.202|TWO_SIDED|95.0|0.86|2.04|||Finkelstein Schoenfeld test|||||2.04|0.86|0.202
72405355|NCT04976530|144318598|SUPERIORITY||win ratio|1.17||||0.451|TWO_SIDED|95.0|0.79|1.73|||Finkelstein Schoenfeld test|||||1.73|0.79|0.451
72405356|NCT04976530|144318599|SUPERIORITY||win ratio|1.59||||0.041|TWO_SIDED|95.0|1.02|2.46|||Finkelstein Schoenfeld test|||||2.46|1.02|0.041
72405357|NCT04976530|144318600|SUPERIORITY|||||||0.6|||||||Wilcoxon (Mann-Whitney)|||||||0.6
72405358|NCT04976530|144318601|SUPERIORITY|||||||0.079|||||||Wilcoxon (Mann-Whitney)|||||||0.079
72518147|NCT01226706|144566122|SUPERIORITY_OR_OTHER|||||||0.029|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|A Bonferroni correction (0.05/n) was used for multiple comparisons||||||0.029
72518148|NCT01226706|144566123|SUPERIORITY_OR_OTHER|||||||0.132|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|A Bonferroni correction (0.05/n) was used for multiple comparisons||||||0.132
72518149|NCT01226706|144566124|SUPERIORITY_OR_OTHER|||||||0.085|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|A Bonferroni correction (0.05/n) was used for multiple comparisons||||||0.085
72518150|NCT01226706|144566125|SUPERIORITY_OR_OTHER|||||||0.099|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|A Bonferroni correction (0.05/n) was used for multiple comparisons||||||0.099
72518151|NCT01226706|144566126|SUPERIORITY_OR_OTHER|||||||0.132|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|A Bonferroni correction (0.05/n) was used for multiple comparisons||||||0.132
72518152|NCT01226706|144566127|SUPERIORITY_OR_OTHER|||||||0.072|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|A Bonferroni correction (0.05/n) was used for multiple comparisons||||||0.072
72518153|NCT01226706|144566128|SUPERIORITY_OR_OTHER|||||||0.23|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|A Bonferroni correction (0.05/n) was used for multiple comparisons||||||0.230
72518154|NCT01226706|144566129|SUPERIORITY_OR_OTHER|||||||0.314|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|A Bonferroni correction (0.05/n) was used for multiple comparisons||||||0.314
72518155|NCT01226706|144566130|SUPERIORITY_OR_OTHER|||||||0.013|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|A Bonferroni correction (0.05/n) was used for multiple comparisons||||||0.013
72518156|NCT01226706|144566131|SUPERIORITY_OR_OTHER|||||||0.888|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|A Bonferroni correction (0.05/n) was used for multiple comparisons||||||0.888
72518157|NCT01899677|144566136|SUPERIORITY_OR_OTHER|||||||0.32|||||||Mann whitney U|||Mann Whitney U test was used to compare cytokine levels between groups.||||0.32
72518158|NCT01899677|144566137|SUPERIORITY_OR_OTHER|||||||0.73|||||||Mann whitney U|||||||0.73
72518159|NCT01899677|144566138|SUPERIORITY_OR_OTHER|||||||0.66|||||||Mann whitney U|||||||0.66
72518160|NCT01899677|144566139|SUPERIORITY_OR_OTHER|||||||0.76|||||||Mann whitney U|||||||0.76
72518161|NCT00118911|144566154|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.631|STANDARD_DEVIATION|7.337|<|0.03|TWO_SIDED|95.0|-8.3|-0.963|||ANCOVA|We used multiple imputation.||Hypothesis was that CBT would be superior to RES||-0.963|-8.30|<.03
72405359|NCT04976530|144318602|SUPERIORITY|||||||0.427|||||||Wilcoxon (Mann-Whitney)|||||||0.427
72405360|NCT04976530|144318603|SUPERIORITY|||||||0.042|||||||Wilcoxon (Mann-Whitney)|||||||0.042
72405361|NCT02643251|144318689|SUPERIORITY|||||||0.3361|||||||Mixed Models Analysis|||||||0.3361
72405362|NCT02633956|144318706|OTHER|Estimation|Least Square Mean Difference|13.79|STANDARD_ERROR_OF_MEAN|5.75|||TWO_SIDED|95.0|2.28|25.3||||||||25.30|2.28|
72405363|NCT02633956|144318706|OTHER|Estimation|Least Square Mean Difference|9.06|STANDARD_ERROR_OF_MEAN|5.61|||TWO_SIDED|95.0|-2.18|20.3||||||||20.30|-2.18|
72569536|NCT02856880|144669964|SUPERIORITY_OR_OTHER||LS mean difference|-270.88||||0.6998|TWO_SIDED|95.0|-1680.58|1138.82||Obtained from ANCOVA including period and treatment as fixed effects, participant as a random effect and participant-level pre-treatment values and period minus participant-level pre-treatment values as covariates in the model.|ANCOVA||Difference is first named treatment minus second named treatment such that a negative difference indicates a smaller live:dead stain ratio for the first named treatment.|||1138.82|-1680.58|0.6998
72492735|NCT02685709|144514111|OTHER||||||||||||||Clopper-Pearson method|||"Secondary endpoints were analyzed without adjustment for multiplicity or predefined noninferiority margins and therefore were interpreted as exploratory.~This endpoint is descriptive with no formal statistical hypothesis testing."|The statistical analysis was based on the stratified Miettinen \& Nurminen (M\&N) method.|||
72492736|NCT02685709|144514112|OTHER|||||||||||||Confidence interval was applied||||"Secondary endpoints were analyzed without adjustment for multiplicity or predefined noninferiority margins and therefore were interpreted as exploratory.~This endpoint is descriptive with no formal statistical hypothesis testing."|The statistical analysis was based on the stratified Miettinen \& Nurminen (M\&N) method.|||
72492737|NCT02685709|144514113|OTHER||||||||||||||Clopper-Pearson method|||Secondary endpoints were analyzed without adjustment for multiplicity or predefined noninferiority margins and therefore were interpreted as exploratory.|Based on this analysis 63.0% of patients in the octreotide capsule group and 51.4% of patients in the SRL injection group entered the Study Extension phase.|||
72492738|NCT02685709|144514114|OTHER|||||||||||||||||"Secondary endpoints were analyzed without adjustment for multiplicity or predefined noninferiority margins and therefore were interpreted as exploratory.~This endpoint is descriptive with no formal statistical hypothesis testing."|The mean change in IGF-1 from RCT Baseline to the end of the RCT phase was calculated using the Last Observation Carried Forward (LOCF) approach.|||
72492739|NCT02685709|144514115|OTHER|||||||||||||||||"Secondary endpoints were analyzed without adjustment for multiplicity or predefined noninferiority margins and therefore were interpreted as exploratory.~This endpoint is descriptive with no formal statistical hypothesis testing."|Estimates were obtained from an analysis of covariance (ANCOVA) for the mean integrated growth hormone (GH) change from baseline with explanatory factors of treatment group and baseline value.|||
72624847|NCT01139515|144779127|SUPERIORITY_OR_OTHER_LEGACY||Adjusted ratio of geometric means|109.48|||||TWO_SIDED|90.0|102.23|117.24||||||Natural log transformed, dose-normalized AUC\[0- ∞\] of eletriptan was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||117.24|102.23|
72405364|NCT02633956|144318706|OTHER|Estimation|Least Square Mean Difference|20.13|STANDARD_ERROR_OF_MEAN|6.39|||TWO_SIDED|95.0|7.33|32.92||||||||32.92|7.33|
72405365|NCT02633956|144318707|OTHER|Estimation|Least Square Mean Difference|0.41|STANDARD_ERROR_OF_MEAN|0.17|||TWO_SIDED|95.0|0.07|0.75||||||||0.75|0.07|
72405366|NCT02633956|144318707|OTHER|Estimation|Least Square Mean Difference|0.09|STANDARD_ERROR_OF_MEAN|0.17|||TWO_SIDED|95.0|-0.25|0.42||||||||0.42|-0.25|
72405367|NCT02633956|144318707|OTHER|Estimation|Least Square Mean Difference|0.51|STANDARD_ERROR_OF_MEAN|0.19|||TWO_SIDED|95.0|0.14|0.89||||||||0.89|0.14|
72405368|NCT02633956|144318708|OTHER|Estimation|Least Square Mean Difference|103.61|STANDARD_ERROR_OF_MEAN|69.51|||TWO_SIDED|95.0|-35.58|242.81||||||||242.81|-35.58|
72405369|NCT02633956|144318708|OTHER|Estimation|Least Square Mean Difference|114.8|STANDARD_ERROR_OF_MEAN|68.08|||TWO_SIDED|95.0|-21.53|251.13||||||||251.13|-21.53|
72405370|NCT02633956|144318708|OTHER|Estimation|Least Square Mean Difference|215.05|STANDARD_ERROR_OF_MEAN|79.51|||TWO_SIDED|95.0|55.84|374.26||||||||374.26|55.84|
72405371|NCT01166594|144318709|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
72405372|NCT01993108|144318719|SUPERIORITY||Mean Difference (Final Values)|0.03||||0.02|TWO_SIDED||||||t-test, 2 sided|||||||.02
72405373|NCT01993108|144318719|SUPERIORITY||Mean Difference (Final Values)|0.02||||0.118|TWO_SIDED||||||t-test, 2 sided|||||||.118
72405374|NCT01993108|144318719|SUPERIORITY||Median Difference (Final Values)|0.02||||0.349|TWO_SIDED||||||t-test, 2 sided|||||||.349
72405375|NCT01993108|144318719|SUPERIORITY||Median Difference (Final Values)|0.02||||0.348|TWO_SIDED||||||t-test, 2 sided|||||||.348
72405376|NCT01993108|144318720|SUPERIORITY||Mean Difference (Final Values)|0.07||||0.019|TWO_SIDED||||||t-test, 2 sided|||||||.019
72405377|NCT01993108|144318720|SUPERIORITY||Mean Difference (Final Values)|0.02||||0.24|TWO_SIDED||||||t-test, 2 sided|||||||.240
72405378|NCT01993108|144318720|SUPERIORITY||Median Difference (Final Values)|0.06||||0.081|TWO_SIDED||||||t-test, 2 sided|||||||.081
72405379|NCT01993108|144318720|SUPERIORITY||Median Difference (Final Values)|0.04||||0.247|TWO_SIDED||||||t-test, 2 sided|||||||.247
72405380|NCT01993108|144318721|SUPERIORITY||Mean Difference (Final Values)|0.05||||0.049|TWO_SIDED||||||t-test, 2 sided|||||||.049
72405381|NCT01993108|144318721|SUPERIORITY||Mean Difference (Final Values)|0.02||||0.497|TWO_SIDED||||||t-test, 2 sided|||||||.497
72405382|NCT01993108|144318721|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.814|TWO_SIDED||||||t-test, 2 sided|||||||.814
72405383|NCT01993108|144318721|SUPERIORITY||Mean Difference (Net)|0.01||||0.593|TWO_SIDED||||||t-test, 2 sided|||||||.593
72492740|NCT02685709|144514116|OTHER|||||||||||||||||This endpoint is descriptive with no formal statistical hypothesis testing|The week 26 value was used as the baseline value for the RCT phase. The denominator for the percentage was the number of subjects at each visit.|||
72492741|NCT02685709|144514117|OTHER|||||||||||||||||This endpoint is descriptive with no formal statistical hypothesis testing.|The week 26 value is used as the baseline value for the RCT phase. The denominator for the percentage was the number of subjects at each visit.|||
72492742|NCT02685709|144514118|OTHER|||||||||||||||||This endpoints is descriptive with no formal statistical hypothesis testing.|This sensitivity analysis was using the Full analysis set (FAS), where any patient who discontinued treatment early was imputed as non-responder.|||
72405384|NCT01993108|144318722|SUPERIORITY||Mean Difference (Final Values)|0.01||||0.926|TWO_SIDED||||||t-test, 2 sided|||||||.926
72405385|NCT01993108|144318722|SUPERIORITY||Mean Difference (Final Values)|0.31||||0.126|TWO_SIDED||||||t-test, 2 sided|||||||.126
72405386|NCT01993108|144318722|SUPERIORITY||Mean Difference (Final Values)|0.04||||0.852|TWO_SIDED||||||t-test, 2 sided|||||||.852
72405387|NCT01993108|144318722|SUPERIORITY||Median Difference (Final Values)|0.11||||0.552|TWO_SIDED||||||t-test, 2 sided|||||||.552
72405388|NCT03064126|144318727|SUPERIORITY||Risk Difference (RD)|0.166||||0.0017|ONE_SIDED|97.5|0.0553||||Chi-squared||||||0.0553|0.0017
72405389|NCT03064126|144318728|NON_INFERIORITY|A Chi-Square Test was used to assess the hypothesis for the difference in 12-month MAE-free rate with non-inferiority margin (-10%).|Risk Difference (RD)|0.106|||<|0.0001|ONE_SIDED|97.5|0.0248||||Chi-squared||||||0.0248|<0.0001
72405390|NCT02775344|144318779|SUPERIORITY||Mean Difference (Final Values)|4.0||||0.198|TWO_SIDED||||||Chi-squared, Corrected|||||||0.198
72492743|NCT02685709|144514119|OTHER|||||||||||||||||This endpoints is descriptive with no formal statistical hypothesis testing|This sensitivity analysis was using the Full analysis set (FAS), where patient who were biochemically controlled at the RCT Baseline (week 26), and who discontinued treatment early was imputed as non-responder.|||
72492744|NCT02685709|144514120|OTHER||Proportion of patients|64.4|||||TWO_SIDED|95.0|56.0|72.1|||||Confidence Interval estimated using the Clopper-Pearson (Exact) method.||The proportion of patients biochemically controlled at the end of the Run-in phase was defined as IGF-1 \< 1.3 times ULN \[based on the average of week 24 and week 26\])|72.1|56|
72492745|NCT02685709|144514121|OTHER||Proportion of patients|66.4|||||TWO_SIDED|95.0|58.5|74.1||||||||74.1|58.5|
72492746|NCT02685709|144514122|OTHER||Proportion of patients|48.9|||||TWO_SIDED|95.0|38.7|59.1||||||||59.1|38.7|
72518162|NCT00118911|144566155|SUPERIORITY_OR_OTHER||Slope|-0.12|STANDARD_DEVIATION|0.59|>|0.05|TWO_SIDED|95.0|-0.41|0.18|||Mixed Models Analysis||Those who were assigned to CBT and made a partial or full response maintained their gains over follow-up|We examined whether those in the CBT condition maintained their gains over time. Analysis was restricted to those assigned to CBT who were responders or partial responders.||.18|-.41|>.05
72518163|NCT03037307|144566202|OTHER||Least square (LS) mean difference|2.76|||<|0.0001|TWO_SIDED|95.0|1.89|3.63||Treatment Comparison for study validity.|ANCOVA|ANCOVA: factors for participant (random effect); period \& treatment, participant-level \& period-level pre-treatment baseline bite force as covariates.|Difference is first-named treatment minus second-named treatment such that a positive difference favours the first named treatment.|||3.63|1.89|<.0001
72405391|NCT02775344|144318780|SUPERIORITY||Mean Difference (Final Values)|0.7||||0.393|TWO_SIDED||||||Chi-squared, Corrected|||||||0.393
72405392|NCT02402452|144318818|OTHER||Geometric Least-Square Mean(GLSM)Ratio %|172.92|||||TWO_SIDED|90.0|97.93|305.33||||||An analysis of variance (ANOVA) appropriate for a parallel design was fitted to the natural logarithmic transformation of voxilaprevir AUClast. A 90% confidence interval (CI) was constructed for the geometric least squares mean (GLSM) ratio of AUClast for the comparison groups using two 1-sided tests.||305.33|97.93|
72405393|NCT02402452|144318819|OTHER||GLSM Ratio (%)|171.27|||||TWO_SIDED|90.0|97.65|300.38||||||An ANOVA appropriate for parallel design was fitted to the natural logarithmic transformation of voxilaprevir AUCinf. A 90% CI was constructed for the GLSM ratio of AUCinf for the comparison groups using two 1-sided tests.||300.38|97.65|
72405394|NCT02402452|144318820|OTHER||GLSM Ratio (%)|145.43|||||TWO_SIDED|90.0|83.77|252.48||||||An ANOVA appropriate for parallel design was fitted to the natural logarithmic transformation of voxilaprevir Cmax. A 90% CI was constructed for the GLSM ratio of Cmax for the comparison groups using two 1-sided tests.||252.48|83.77|
72405395|NCT00559962|144318822|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.68|||<|0.001|TWO_SIDED|95.0|2.3|7.07|||ANOVA|||One-way analysis of variance (ANOVA) to compare the absolute change from baseline to Week 12 in percent hepatic fat between AEGR-755 5 mg and placebo.||7.07|2.30|<0.001
72405396|NCT00559962|144318823|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.92|||<|0.001|TWO_SIDED|95.0|2.27|7.57||(All comparisons)|ANOVA|||One-way ANOVA to compare the absolute change from baseline to Week 12 in percent hepatic fat between active treatment groups and placebo||7.57|2.27|<0.001
72405397|NCT00559962|144318823|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.68|||<|0.001|TWO_SIDED|95.0|2.3|7.07||(All comparisons)|ANOVA|||||7.07|2.30|<0.001
72405398|NCT00559962|144318823|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.91|||<|0.001|TWO_SIDED|95.0|1.73|6.1||(All comparisons)|ANOVA|||One-way ANOVA to compare the absolute change from baseline to Week 12 in percent hepatic fat between active treatment groups and placebo||6.10|1.73|<0.001
72405399|NCT00559962|144318823|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.82|||<|0.001|TWO_SIDED|95.0|4.31|11.33||(All comparisons)|ANOVA|||||11.33|4.31|<0.001
72405400|NCT00559962|144318823|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.65|||<|0.001|TWO_SIDED|95.0|1.58|5.72||(All comparisons)|ANOVA|||One-way ANOVA to compare the absolute change from baseline to Week 12 in percent hepatic fat between active treatment groups and placebo||5.72|1.58|<0.001
72492747|NCT02685709|144514126|OTHER||||||||||||||||||The LSM change from baseline estimates are from a mixed model for repeated measures.|||
72492748|NCT04417894|144514133|SUPERIORITY||||||=|0.003|||||||Cochran-Mantel-Haenszel|||||||=0.0030
72492749|NCT04417894|144514134|SUPERIORITY||Difference|38.6|||<|0.0001|TWO_SIDED|95.0|24.06|53.15|||Mantel Haenszel|||||53.15|24.06|<0.0001
72492750|NCT03440814|144514153|SUPERIORITY||Mean Difference (Final Values)|-1.67|STANDARD_ERROR_OF_MEAN|1.294||0.1983|TWO_SIDED|95.0|-4.24|0.89|||Mixed Models Analysis|MMRM analysis adjusted for baseline growth hormone use and HQ-CT total score. All available subject data were used with no imputation of missing data.|alpha=0.05 level of significance|||0.89|-4.24|0.1983
72492751|NCT03440814|144514154|SUPERIORITY|||||||0.0294|||||||Cochran-Mantel-Haenszel|Treatment groups were compared using CMH mean score test with modified ridit scores, stratified by the randomization stratification variables.||||||0.0294
72492752|NCT03440814|144514155|SUPERIORITY|||||||0.4089|||||||Cochran-Mantel-Haenszel|Treatment groups were compared using CMH mean score test with modified ridit scores, stratified by the randomization stratification variables.||||||0.4089
72492753|NCT03440814|144514156|SUPERIORITY||Mean Difference (Final Values)|-1.05|STANDARD_ERROR_OF_MEAN|0.458||0.0225|TWO_SIDED|95.0|-1.95|-0.15|||ANCOVA|ANCOVA adjusted for baseline body fat mass value as a covariate, and randomization stratification variables (as randomized) as factors.||||-0.15|-1.95|0.0225
72492754|NCT03440814|144514157|SUPERIORITY||Mean Difference (Final Values)|-3.13|STANDARD_ERROR_OF_MEAN|1.481||0.0369|TWO_SIDED|95.0|-6.06|-0.19|||Mixed Models Analysis|Linear mixed model for repeated measurements was used. All available data collected before the March 1, 2020 cutoff from each subject were included.|alpha=0.05 level of significance|||-0.19|-6.06|0.0369
72492755|NCT00879697|144514158|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||ANOVA|||The effect of training in both groups were assessed by a 2-way ANOVA (Time x Group) for repeated measures. When significance was obtained, the Newman-Keuls post hoc test was used to identify the differences.||||<0.05
72492756|NCT01110200|144514189|SUPERIORITY_OR_OTHER||Treatment comparison ratio|0.917||||0.71|TWO_SIDED|95.0|0.581|1.447|||Negative bionomial regression model||Annualized rate estimates, the treatment comparison ratio, the confidence interval, and the p-value are from a negative binomial regression model with terms for treatment, country, randomization stratum, baseline severity, and time on treatment.|||1.447|0.581|0.710
72518164|NCT03037307|144566203|OTHER||Least Square (LS) mean difference|2.12|||<|0.0001|TWO_SIDED|95.0|1.25|3.0|||ANCOVA|ANCOVA: factors for participant (random effect); period \& treatment, participant-level \& period-level pre-treatment baseline bite force as covariates|Difference is first-named treatment minus second-named treatment such that a positive difference favours the first named treatment.|||3.00|1.25|<.0001
72518165|NCT01700985|144566245|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||||||<0.0001
72518166|NCT01700985|144566246|SUPERIORITY||||||<|0.0001||||||At Day 15.|Fisher Exact|||||||<0.0001
72518167|NCT01700985|144566247|SUPERIORITY||||||<|0.0001||||||At Day 15.|Fisher Exact|||||||<0.0001
72518168|NCT05067452|144566256|SUPERIORITY||Slope|-0.092|STANDARD_ERROR_OF_MEAN|0.721||0.9|TWO_SIDED|95.0|-1.59|1.4|||ANCOVA|||||1.40|-1.59|0.900
72518169|NCT05067452|144566257|SUPERIORITY||Slope|1.37|STANDARD_ERROR_OF_MEAN|0.945||0.146|TWO_SIDED|95.0|-0.478|3.23|||Mixed Models Analysis|||||3.23|-0.478|0.146
72518170|NCT05067452|144566258|SUPERIORITY||Risk Difference (RD)|0.235|STANDARD_ERROR_OF_MEAN|0.212||0.281|TWO_SIDED|95.0|-0.207|0.677|||ANCOVA|Linear regression used with the binary outcome (linear probability model)||||0.677|-0.207|0.281
72518171|NCT05067452|144566259|SUPERIORITY||Risk Difference (RD)|0.354|STANDARD_ERROR_OF_MEAN|0.211||0.094|TWO_SIDED|95.0|-0.06|0.768|||Mixed Models Analysis|Linear regression used with the binary outcome (linear probability model)||||0.768|-0.060|0.094
72518172|NCT05067452|144566260|SUPERIORITY||Slope|2.18|STANDARD_ERROR_OF_MEAN|5.11||0.669|TWO_SIDED|95.0|-7.83|12.2|||Mixed Models Analysis|||||12.2|-7.83|0.669
72518173|NCT05067452|144566261|SUPERIORITY||Slope|-0.024|STANDARD_ERROR_OF_MEAN|0.367||0.949|TWO_SIDED|95.0|-0.695|0.743|||Mixed Models Analysis|||||0.743|-0.695|0.949
72518174|NCT05067452|144566262|SUPERIORITY||Slope|-0.54|STANDARD_ERROR_OF_MEAN|0.53||0.308|TWO_SIDED|95.0|-1.58|0.679|||Mixed Models Analysis|||||0.679|-1.58|0.308
72518175|NCT05067452|144566263|SUPERIORITY||Slope|-1.02|STANDARD_ERROR_OF_MEAN|1.91||0.593|TWO_SIDED|95.0|-4.77|0.499|||Mixed Models Analysis|||||0.499|-4.77|0.593
72492757|NCT00903175|144514192|NON_INFERIORITY_OR_EQUIVALENCE|Primary objective was to assess the non-inferiority of everolimus as compared to Sunitinib in terms of PFS-1L \& was based on Bayesian methodology. If the estimated HR for PFS-1L had a value ≤ 1.1, non-inferiority of everolimus to Sunitinib would be declared. Non-inferiority of everolimus compared with Sunitinib as a first-line therapy was not achieved. The estimated HR for PFS-1L was 1.43 which did not satisfy the protocol-defined non-inferiority margin of a HR ≤ 1.1.|Hazard Ratio (HR)|1.43|||||TWO_SIDED|95.0|1.15|1.77||||||||1.77|1.15|
72492758|NCT04817111|144514221|OTHER|Wilcoxon signed-rank test was used to test if the change from pre- vs. post-test outcome is different from zero.||||||0.18|||||||Wilcoxon (Mann-Whitney)|||||||0.18
72518176|NCT05067452|144566264|SUPERIORITY||Slope|-2.63|STANDARD_ERROR_OF_MEAN|1.65||0.112|TWO_SIDED|95.0|-5.86|0.611|||Mixed Models Analysis|||||0.611|-5.86|0.112
72518177|NCT05067452|144566267|SUPERIORITY||Slope|-2.66|STANDARD_ERROR_OF_MEAN|2.85||0.349|TWO_SIDED|95.0|-8.25|2.92|||Mixed Models Analysis|||||2.92|-8.25|0.349
72518178|NCT03859960|144566268|OTHER|||||||0.006|||||||Pearson correlation test|||||||0.006
72518179|NCT03859960|144566268|OTHER|||||||0.23||||||p\<0.05 was considered statisticaly significant.|Pearson correlation test|||||||0.23
72518180|NCT03859960|144566269|OTHER|||||||0.001||||||p\<0.05 was considered statisticaly significant.|Pearson correlation test|||||||0.001
72518181|NCT03859960|144566269|OTHER|||||||0.731|||||||Pearson correlation test|||||||0.731
72518182|NCT03859960|144566270|OTHER|||||||0.214|||||||Pearson correlation test|||||||0.214
72518183|NCT03859960|144566270|OTHER|||||||0.993||||||p\<0.05 was considered statisticaly significant.|Pearson correlation test|||||||0.993
72518184|NCT03859960|144566271|OTHER|||||||0.41|||||||Pearson correlation test|||||||0.41
72518185|NCT03859960|144566271|OTHER|||||||0.676|||||||Pearson correlation test|||||||0.676
72518186|NCT03859960|144566272|OTHER|||||||0.511||||||p\<0.05 was considered statisticaly significant.|Pearson correlation test|||||||0.511
72518187|NCT03859960|144566272|OTHER|||||||0.248|||||||Pearson correlation test|||||||0.248
72518188|NCT03859960|144566273|OTHER|||||||0.654|||||||Pearson correlation test|||||||0.654
72518189|NCT03859960|144566273|OTHER|||||||0.025|||||||Pearson correlation test|||||||0.025
72518190|NCT00067470|144566284|SUPERIORITY_OR_OTHER||Mean Difference (Net)|92.0|STANDARD_ERROR_OF_MEAN|40.0||0.025||95.0|11.0|172.0|||Regression, Linear|||||172|11|0.025
72518191|NCT00067470|144566285|SUPERIORITY_OR_OTHER||Mean Difference (Net)|5.7|STANDARD_ERROR_OF_MEAN|2.9||0.053||95.0|-0.1|11.5|||Regression, Linear|The raw data were adjusted for the observed differences in baseline between the groups and fitted to a longitudinal repeated measures linear model.||||11.5|-0.1|0.053
72518192|NCT01192204|144566290|SUPERIORITY_OR_OTHER|||||||0.048|TWO_SIDED|||||Statistical analyses reflect percent change intrapatient pre versus post histologic grade scores|Wilcoxon matched-pairs signed rank test|We used a 2-tailed Mann Whitney U test to evaluate these data.||Wilcoxon matched-pairs signed rank test (intrapatient pre versus post treatment scores)||||0.048
72518193|NCT01192204|144566290|SUPERIORITY_OR_OTHER|||||||0.5|TWO_SIDED|||||Statistical analyses reflect percent change pre versus post histologic grade scores|Wilcoxon matched-pairs signed rank test|||Wilcoxon matched-pairs signed rank test (pre versus post treatment scores)||||0.50
72518194|NCT01192204|144566291|SUPERIORITY_OR_OTHER||||||<|0.002|TWO_SIDED||||||Wilcoxon matched-pairs signed rank test|specifically, we used the Wilcoxon matched-pairs signed rank test.||||||<0.002
72518195|NCT01192204|144566291|SUPERIORITY_OR_OTHER|||||||0.036|TWO_SIDED||||||Wilcoxon matched-pairs signed rank test|||||||0.036
72518196|NCT01192204|144566292|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED||||||2-tailed unpaired t test|||||||0.002
72492759|NCT04817111|144514223|OTHER|Wilcoxon signed-rank test was used to test if the change from pre- vs. post-test outcome is different from zero.||||||0.21|||||||Wilcoxon (Mann-Whitney)|||||||0.21
72492760|NCT04817111|144514224|OTHER|Wilcoxon signed-rank test was used to test if the change from pre- vs. post-test outcome is different from zero.||||||0.03|||||||Wilcoxon (Mann-Whitney)|||||||0.03
72492761|NCT01318109|144514225|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.751|||||TWO_SIDED|95.0|-0.923|-0.579||||||||-0.579|-0.923|
72492762|NCT01318109|144514225|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.858|||||TWO_SIDED|95.0|-1.019|-0.697||||||||-0.697|-1.019|
72492763|NCT01318109|144514226|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.191|||||TWO_SIDED|95.0|-0.247|-0.135||||||||-0.135|-0.247|
72492764|NCT01318109|144514226|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.192|||||TWO_SIDED|95.0|-0.242|-0.143||||||||-0.143|-0.242|
72492765|NCT01318109|144514227|SUPERIORITY_OR_OTHER||Hazard Ratio, log|-0.386|||||TWO_SIDED|95.0|-0.469|-0.303||||||||-0.303|-0.469|
72492766|NCT01318109|144514227|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.403|||||TWO_SIDED|95.0|-0.484|-0.323||||||||-0.323|-0.484|
72492767|NCT01318109|144514228|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.621|||||TWO_SIDED|95.0|-0.757|-0.486||||||||-0.486|-0.757|
72518197|NCT01192204|144566292|SUPERIORITY_OR_OTHER|||||||0.16|TWO_SIDED||||||two-tailed unpaired t test|||||||0.16
72518198|NCT01948141|144566297|SUPERIORITY_OR_OTHER|||||||0.59|||||||Log Rank|||||||0.59
72518199|NCT01948141|144566300|SUPERIORITY_OR_OTHER|||||||0.36|||||||Log Rank|||||||0.36
72518200|NCT03796182|144566314|EQUIVALENCE|The corresponding 90% confidence intervals equivalence criteria was (80%, 125%) acceptance range.|Ratio|98.5|||||TWO_SIDED|90.0|82.09|118.2||||||||118.20|82.09|
72492768|NCT01318109|144514228|SUPERIORITY_OR_OTHER||Hazard Ratio, log|-0.692|||||TWO_SIDED|95.0|-0.814|-0.569||||||||-0.569|-0.814|
72492769|NCT01318109|144514229|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.26|||||TWO_SIDED|95.0|-26.12|-12.4||||||||-12.40|-26.12|
72492770|NCT01318109|144514229|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-23.27|||||TWO_SIDED|95.0|-30.43|-16.12||||||||-16.12|-30.43|
72492771|NCT01318109|144514230|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.6|||||TWO_SIDED|95.0|-24.54|-10.66||||||||-10.66|-24.54|
72492772|NCT01318109|144514230|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-21.35|||||TWO_SIDED|95.0|-28.32|-14.39||||||||-14.39|-28.32|
72492773|NCT01318109|144514231|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-18.87|||||TWO_SIDED|95.0|-25.95|-11.79||||||||-11.79|-25.95|
72492774|NCT01318109|144514231|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-18.16|||||TWO_SIDED|95.0|-25.43|-10.9||||||||-10.90|-25.43|
72492775|NCT01318109|144514232|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-18.24|||||TWO_SIDED|95.0|-26.32|-10.16||||||||-10.16|-26.32|
72492776|NCT01318109|144514232|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-22.38|||||TWO_SIDED|95.0|-30.87|-13.88||||||||-13.88|-30.87|
72492777|NCT01318109|144514233|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.89|||||TWO_SIDED|95.0|-20.14|2.37||||||||2.37|-20.14|
72492778|NCT01318109|144514233|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.41|||||TWO_SIDED|95.0|-16.34|3.52||||||||3.52|-16.34|
72492779|NCT02193074|144514245|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentages|50.68|||<|0.0001|TWO_SIDED|95.0|31.81|66.48|||Fisher Exact||exact unconditional confidence interval|||66.48|31.81|< 0.0001
72492780|NCT02193074|144514246|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0046|||||||Log Rank|Based on log-rank test stratified by disease duration.||||||0.0046
72492781|NCT02193074|144514246|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.53||||0.0164|TWO_SIDED|95.0|0.3156|0.8902|||Cox proportional hazards model|Based on Cox proportional hazards model adjusted for each subject's disease duration at screening.||||0.8902|0.3156|0.0164
72492782|NCT02193074|144514247|SUPERIORITY_OR_OTHER_LEGACY||DIfference in percentages|68.53|||<|0.0001|TWO_SIDED|95.0|51.27|81.99|||Fisher Exact|||||81.99|51.27|< 0.0001
72492783|NCT02193074|144514248|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0041|||||||Log Rank|Based on log-rank test stratified by disease duration (primary analysis).||||||0.0041
72492784|NCT02193074|144514248|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.372||||0.0082|TWO_SIDED|95.0|0.1787|0.7745|||Cox proportional hazards|Based on Cox proportional hazards model adjusted for each subject's disease duration at screening (sensitivity analysis).||||0.7745|0.1787|0.0082
72492785|NCT02193074|144514250|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentages|30.21||||0.0004|TWO_SIDED|95.0|10.35|48.09|||Fisher Exact|||||48.09|10.35|0.0004
72492786|NCT02193074|144514251|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0003|||||||Log Rank|||||||0.0003
72492787|NCT02193074|144514251|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.24||||0.0014|TWO_SIDED|95.0|0.1002|0.5753|||Cox proportional hazards|Based on Cox proportional hazards model adjusted for each subject's disease duration at screening.||||0.5753|0.1002|0.0014
72492788|NCT02193074|144514252|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3953|||||||Log Rank|||||||0.3953
72518201|NCT03796182|144566315|EQUIVALENCE|The corresponding 90% confidence intervals equivalence criteria was (80%, 125%) acceptance range.|Ratio|93.49|||||TWO_SIDED|90.0|85.15|102.65||||||||102.65|85.15|
72518202|NCT03796182|144566316|EQUIVALENCE|The corresponding 90% confidence intervals equivalence criteria was (80%, 125%) acceptance range.|Ratio|88.07|||||TWO_SIDED|90.0|80.99|95.76||||||||95.76|80.99|
72518203|NCT03796182|144566318|EQUIVALENCE|The corresponding 90% confidence intervals equivalence criteria was (80%, 125%) acceptance range.|Ratio|94.25|||||TWO_SIDED|90.0|88.19|100.73||||||||100.73|88.19|
72518204|NCT04682353|144566328|OTHER||Geometric Mean Ratio|0.976|||||TWO_SIDED|90.0|0.748|1.274||||||||1.274|0.748|
72518205|NCT04682353|144566328|OTHER||Geometric Mean Ratio|1.226|||||TWO_SIDED|90.0|0.94|1.598||||||||1.598|0.940|
72518206|NCT04682353|144566328|OTHER||Geometric Mean Ratio|1.817|||||TWO_SIDED|90.0|1.38|2.392||||||||2.392|1.380|
72518207|NCT04682353|144566330|OTHER||Geometric Mean Ratio|1.202|||||TWO_SIDED|90.0|0.96|1.506||||||||1.506|0.960|
72518208|NCT04682353|144566330|OTHER||Geometric Mean Ratio|1.393|||||TWO_SIDED|90.0|1.07|1.815||||||||1.815|1.070|
72518209|NCT04682353|144566330|OTHER||Geometric Mean Ratio|2.301|||||TWO_SIDED|90.0|1.806|2.933||||||||2.933|1.806|
72518210|NCT04682353|144566331|OTHER||Geometric Mean Ratio|1.699|||||TWO_SIDED|90.0|0.921|3.135||||||||3.135|0.921|
72518211|NCT04682353|144566331|OTHER||Geometric Mean Ratio|2.364|||||TWO_SIDED|90.0|1.273|4.39||||||||4.390|1.273|
72492789|NCT02193074|144514252|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.844||||0.6268|TWO_SIDED|95.0|0.427|1.6698|||Cox proportional hazards|Based on Cox proportional hazards model adjusted for each subject's disease duration at screening.||||1.6698|0.4270|0.6268
72492790|NCT03124563|144514259|SUPERIORITY||||||=|0.006|||||||Mixed Models Analysis|Controlling for age, gender, and functional health||||||=.006
72492791|NCT03124563|144514260|SUPERIORITY|||||||0.034|||||||Mixed Models Analysis|Controlling for age, gender, and functional health||||||.034
72492792|NCT03124563|144514261|SUPERIORITY|||||||0.065|||||||Mixed Models Analysis|Controlling for age, gender, and education||||||.065
72492793|NCT03124563|144514262|SUPERIORITY|||||||0.308|||||||Mixed Models Analysis|Controlling for age, gender, and level of education||||||.308
72492794|NCT03124563|144514263|SUPERIORITY|||||||0.349|||||||ANOVA|||||||.349
72492795|NCT03124563|144514264|SUPERIORITY|||||||0.022|||||||Mixed Models Analysis|Controlling for age, gender, and level of education||||||.022
72492796|NCT01534533|144514265|SUPERIORITY_OR_OTHER||||||>|0.05||95.0||||The a priori threshold for statistical significance was 0.05 (two sides)|Chi-squared|||"The null hypothesis was no group difference"||||>0.05
72492797|NCT01534533|144514266|SUPERIORITY_OR_OTHER|||||||0.992||95.0||||The a priori threshold for statistical significance was 0.05 (two sides)|ANOVA|||"The null hypothesis was no group difference"||||0.992
72492798|NCT01534533|144514267|SUPERIORITY_OR_OTHER|||||||0.672||95.0||||The a priori threshold for statistical significance was 0.05 (two sides)|ANOVA|||"The null hypothesis was no group difference"||||0.672
72492799|NCT01534533|144514268|SUPERIORITY_OR_OTHER|||||||0.402||95.0||||The a priori threshold for statistical significance was 0.05 (two sides)|ANOVA|||"The null hypothesis was no group difference"||||0.402
72492800|NCT01534533|144514269|SUPERIORITY_OR_OTHER|||||||0.636||95.0||||The a priori threshold for statistical significance was 0.05 (two sides)|ANOVA|||"The null hypothesis was no group difference"||||0.636
72492801|NCT04311502|144514273|SUPERIORITY||Hazard Ratio (HR)|1.21||||0.21|TWO_SIDED|90.0|0.82|1.79|||Regression, Cox|Adjusted for HIV-1 status (positive/negative) and TB Disease at Screening (Advanced/Not Advanced).|Arm 1 vs Arm 2|This comparison is adjusting for HIV-1 status (positive/negative) and TB Disease at Screening (Advanced/Not Advanced).||1.79|0.82|0.21
72492802|NCT04311502|144514274|SUPERIORITY||Risk Difference (RD)|0.3|||<|0.01|TWO_SIDED|90.0|0.14|0.45|||Wald chi-square test||Difference in cumulative proportions (Arm 1 - Arm 2)|"The point estimate and 90% two-sided confidence intervals for the difference in cumulative proportions of participants experiencing a Grade 3 or higher AE that is at least one-grade increase from baseline at any time during the 65-week study period was compared between Arm 1 and Arm 2.~This outcome measure is limited to data obtained up to September 25, 2023."||0.45|0.14|<0.01
72492803|NCT04311502|144514274|SUPERIORITY||Risk Difference (RD)|0.28|||<|0.01|TWO_SIDED|90.0|0.11|0.44|||Wald chi-square test||Difference in cumulative proportions (Arm 1 - Arm 2)|"The point estimate and 90% two-sided confidence intervals for the difference in cumulative proportions of participants experiencing a Grade 3 or higher AE that is at least one-grade increase from baseline at any time during the 65-week study period was compared between Arm 1 and Arm 2.~All data through week 65."||0.44|0.11|<0.01
72492804|NCT04311502|144514275|SUPERIORITY||Risk Difference (RD)|-0.26||||0.01|TWO_SIDED|95.0|-0.47|-0.06|||Wald chi-square test||Difference in cumulative proportions (Arm 1 - Arm 2)|The point estimate and 95% two-sided confidence interval for the difference in cumulative proportions of participants experiencing a favorable outcome through week 65 was compared between Arm 1 and Arm 2.||-0.06|-0.47|0.01
72492805|NCT04311502|144514276|SUPERIORITY||Risk Difference (RD)|-0.25||||0.02|TWO_SIDED|95.0|-0.46|-0.04|||Wald chi-square||Difference in cumulative proportions (Arm 1 - Arm 2)|The point estimate and 95% two-sided confidence interval for the difference in cumulative proportions of participants experiencing a favorable outcome through week 65 was compared between Arm 1 and Arm 2.||-0.04|-0.46|0.02
72492806|NCT04311502|144514277|SUPERIORITY|Fisher's exact test was used to test for a difference in proportions|Risk Difference (RD)|-0.06||||0.35|TWO_SIDED|95.0|-0.22|0.05|||Fisher Exact||Difference in proportions (Arm 1 - Arm 2); exact confidence interval|||0.05|-0.22|0.35
72492807|NCT04311502|144514279|SUPERIORITY||GEE|24.04|||<|0.01|TWO_SIDED|95.0|15.13|32.94|||Regression, Linear|||||32.94|15.13|<0.01
72492808|NCT04311502|144514281|SUPERIORITY||Odds Ratio (OR)|7.15|||<|0.01|TWO_SIDED|95.0|2.4|21.3|||Regression, Logistic|||Compares the odds of participants having maximum occurrence of QTcF change from baseline of ≥30 ms and \<60 ms, or ≥60 ms between Arm 1 and Arm 2 in the safety set using the proportional odds model.||21.30|2.40|<0.01
72492809|NCT04311502|144514281|SUPERIORITY||Risk Difference (RD)|0.41|||<|0.01|TWO_SIDED|95.0|0.17|0.58|||exact unconditional||Arm 1 - Arm 2|Proportion of Participants with Worst Changes in QTcF from Screening \>= 30 ms over visits at Weeks 2, 8, 13||0.58|0.17|<0.01
72492810|NCT04311502|144514282|SUPERIORITY||Hazard Ratio (HR)|1.23||||0.18|TWO_SIDED|90.0|0.84|1.8||One-sided p-value|Regression, Cox|Adjusted for HIV status (positive/negative) and TB disease according to chest X-ray (advanced/not advanced)|Arm 1 vs. Arm 2|||1.80|0.84|0.18
72492811|NCT04311502|144514283|SUPERIORITY||Hazard Ratio (HR)|1.17||||0.25|TWO_SIDED|90.0|0.8|1.71||One-sided p-value|Regression, Cox|||This comparison is adjusting for HIV-1 status (positive/negative) and TB Disease at Screening (Advanced/Not Advanced).||1.71|0.80|0.25
72492812|NCT04311502|144514284|SUPERIORITY||Risk Difference (RD)|0.13||||0.23|TWO_SIDED|95.0|-0.07|0.35|||Fisher Exact|||||0.35|-0.07|0.23
72492813|NCT04311502|144514285|SUPERIORITY||Risk Difference (RD)|0.05||||0.56|TWO_SIDED|95.0|-0.11|0.24|||Fisher Exact|||||0.24|-0.11|0.56
72492814|NCT04311502|144514286|SUPERIORITY||Risk Difference (RD)|0.07||||0.27|TWO_SIDED|90.0|-0.04|0.18|||Wald chi-square test||Difference in cumulative proportions (Arm 1 - Arm 2)|The point estimate and 90% two-sided confidence intervals for the difference in cumulative proportions of participants experiencing an SAE through week 65 was compared between Arm 1 and Arm 2.||0.18|-0.04|0.27
72518212|NCT04682353|144566331|OTHER||Geometric Mean Ratio|3.748|||||TWO_SIDED|90.0|2.033|6.908||||||||6.908|2.033|
72518213|NCT04682353|144566332|OTHER||Geometric Mean Ratio|1.904|||||TWO_SIDED|90.0|0.886|4.093||||||||4.093|0.886|
72518214|NCT04682353|144566332|OTHER||Geometric Mean Ratio|3.317|||||TWO_SIDED|90.0|1.585|6.942||||||||6.942|1.585|
72518215|NCT04682353|144566332|OTHER||Geometric Mean Ratio|5.824|||||TWO_SIDED|90.0|2.796|12.135||||||||12.135|2.796|
72518216|NCT04682353|144566333|OTHER||Geometric Mean Ratio|1.095|||||TWO_SIDED|90.0|0.92|1.302||||||||1.302|0.920|
72518217|NCT04682353|144566333|OTHER||Geometric Mean Ratio|1.415|||||TWO_SIDED|90.0|1.148|1.744||||||||1.744|1.148|
72569537|NCT02856880|144669964|SUPERIORITY_OR_OTHER||LS mean difference|-1037.52||||0.121|TWO_SIDED|95.0|-2361.33|286.29||Obtained from ANCOVA including period and treatment as fixed effects, participant as a random effect and participant -level pre-treatment values and period minus participant -level pre-treatment values as covariates in the model.|ANCOVA||Difference is first named treatment minus second named treatment such that a negative difference indicates a smaller live:dead stain ratio for the first named treatment.|||286.29|-2361.33|0.1210
72492815|NCT04311502|144514287|SUPERIORITY|Fisher's exact test was used to test for a difference in proportions|Risk Difference (RD)|0.0||||1|TWO_SIDED|95.0|-0.1|0.13|||Fisher Exact||Difference in proportions (Arm 1 - Arm 2); exact confidence interval|||0.13|-0.10|1
72569538|NCT02856880|144669964|SUPERIORITY_OR_OTHER||LS mean difference|-89.54||||0.8935|TWO_SIDED|95.0|-1439.5|1260.41||Obtained from ANCOVA including period and treatment as fixed effects, participant as a random effect and participant-level pre-treatment values and period minus participant-level pre-treatment values as covariates in the model.|ANCOVA||Difference is first named treatment minus second named treatment such that a negative difference indicates a smaller live:dead stain ratio for the first named treatment.|||1260.41|-1439.50|0.8935
72492816|NCT04311502|144514288|SUPERIORITY||Hazard Ratio (HR)|0.89||||0.597|TWO_SIDED|95.0|0.57|1.39|||Regression, Cox|||Time point: Screening||1.39|0.57|0.597
72492817|NCT04311502|144514288|SUPERIORITY||Hazard Ratio (HR)|0.92||||0.7|TWO_SIDED|95.0|0.58|1.44|||Regression, Cox|||Time point: Entry||1.44|0.58|0.70
72492818|NCT04311502|144514288|SUPERIORITY||Hazard Ratio (HR)|0.64||||0.07|TWO_SIDED|95.0|0.4|1.03|||Regression, Cox|||Time point: Week 2||1.03|0.40|0.07
72492819|NCT04311502|144514288|SUPERIORITY||Hazard Ratio (HR)|0.58||||0.04|TWO_SIDED|95.0|0.34|0.98|||Regression, Cox|||Time point: Week 4||0.98|0.34|0.04
72492820|NCT04311502|144514288|SUPERIORITY||Hazard Ratio (HR)|0.83||||0.6|TWO_SIDED|95.0|0.41|1.67|||Regression, Cox|||Time point: Week 6||1.67|0.41|0.60
72492821|NCT04311502|144514288|SUPERIORITY||Hazard Ratio (HR)|0.79||||0.595|TWO_SIDED|95.0|0.33|1.88|||Regression, Cox|||Time point: Week 8||1.88|0.33|0.595
72492822|NCT04311502|144514288|SUPERIORITY||Hazard Ratio (HR)|0.78||||0.66|TWO_SIDED|95.0|0.25|2.44|||Regression, Cox|||Time point: Week 10||2.44|0.25|0.66
72492823|NCT04311502|144514288|SUPERIORITY||Hazard Ratio (HR)|1.17||||0.86|TWO_SIDED|95.0|0.21|6.39|||Regression, Cox|||Time point: Week 12||6.39|0.21|0.86
72492824|NCT04311502|144514289|SUPERIORITY||Slope|20.43|||<|0.01|TWO_SIDED|95.0|5.71|35.16|||Regression, Linear|||This comparison is adjusting for HIV-1 status (positive/negative) and TB Disease at Screening (Advanced/Not Advanced).||35.16|5.71|<0.01
72492825|NCT03040999|144514301|SUPERIORITY||Hazard Ratio (HR)|0.9||||0.1997|TWO_SIDED|95.0|0.71|1.15|||Log Rank|One-sided p-value based on log-rank test stratified by human papilloma virus (HPV) status and overall cancer stage.|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by HPV status and overall cancer stage.|||1.15|0.71|0.1997
72492826|NCT03040999|144514304|OTHER||Difference in Least squares mean|-4.24||||0.0015|TWO_SIDED|95.0|-6.85|-1.63|||cLDA||Based on a cLDA model with the PRO scores as the response variable with covariates for treatment, time, treatment by time interaction, and stratification factors of HPV status and overall cancer stage.|Difference in Least Squares Mean||-1.63|-6.85|0.0015
72492827|NCT03040999|144514305|OTHER||Difference in Least squares mean|-0.51||||0.7719|TWO_SIDED|95.0|-3.98|2.96|||cLDA||Based on a cLDA model with the PRO scores as the response variable with covariates for treatment, time, treatment by time interaction, and stratification factors of HPV status and overall cancer stage.|Difference in Least Squares Mean||2.96|-3.98|0.7719
72492828|NCT03040999|144514306|OTHER||Difference in Least squares mean|-1.29||||0.45|TWO_SIDED|95.0|-4.64|2.06|||cLDA||Based on a cLDA model with the PRO scores as the response variable with covariates for treatment, time, treatment by time interaction, and stratification factors of HPV status and overall cancer stage.|Difference in Least Squares Mean||2.06|-4.64|0.4500
72492829|NCT03040999|144514307|OTHER||Difference in Least squares mean|1.29||||0.3524|TWO_SIDED|95.0|-1.43|4.02|||cLDA||Based on a cLDA model with the PRO scores as the response variable with covariates for treatment, time, treatment by time interaction, and stratification factors of HPV status and overall cancer stage.|Difference in Least Squares Mean||4.02|-1.43|0.3524
72492830|NCT03040999|144514308|OTHER||Difference in Least squares mean|-2.05||||0.0963|TWO_SIDED|95.0|-4.47|0.37|||cLDA||Based on a cLDA model with the PRO scores as the response variable with covariates for treatment, time, treatment by time interaction, and stratification factors of HPV status and overall cancer stage.|Difference in Least Squares Mean||0.37|-4.47|0.0963
72492831|NCT03040999|144514309|SUPERIORITY||Hazard Ratio (HR)|0.83||||0.0429|TWO_SIDED|95.0|0.68|1.03||P-value crossing boundary of 0.0242 required for statistical significance.|Log Rank|One-sided p-value based on log-rank test stratified by human papilloma virus (HPV) status and overall cancer stage.|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by HPV status and overall cancer stage.|||1.03|0.68|0.0429
72492832|NCT01408147|144514310|SUPERIORITY||Mean Difference (Final Values)|2.3|||<|0.0001|TWO_SIDED|95.0|||||Mixed Models Analysis|||To test the primary hypothesis, a generalized linear mixed effect model was used (intervention group as a fixed effect and clinic and subject as random effects). A group x time interaction term (fixed effect) tested if the change in weight over time differed significantly. The model included participant-level covariates (i.e., ethnicity, weeks postpartum at study entry, lactation, and age).||||<0.0001
72492833|NCT01661140|144514312|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority if the difference between treatments is statistically significant and the lower limit of the 95% confidence interval (CI) is greater than 0.9.|Odds Ratio (OR)|1.803||||0.036|TWO_SIDED|95.0|1.037|3.133|||Analysis by logistic regression|||Comparison was Tapering MTX : MTX maintenance. Last post-baseline EULAR response recorded used for participants with a missing result at Week 60.||3.133|1.037|0.036
72492834|NCT00132132|144514357|SUPERIORITY_OR_OTHER|||||||0.03||95.0|||||t-test, 2 sided|This analysis is the per protocol unadjusted value||||||0.03
72492835|NCT00132132|144514357|SUPERIORITY_OR_OTHER|||||||0.14||95.0|||||t-test, 2 sided|Age adjusted per protocol||||||0.14
72492836|NCT00132132|144514357|SUPERIORITY_OR_OTHER|||||||0.006||95.0|||||t-test, 2 sided|Per protocol adjusted for age and paternal education. Given the small number of participants with complete data, this model may be overfit.||||||0.006
72492837|NCT00132132|144514358|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||Chi-squared|||||||0.02
72518218|NCT04682353|144566333|OTHER||Geometric Mean Ratio|2.017|||||TWO_SIDED|90.0|1.692|2.405||||||||2.405|1.692|
72518219|NCT04682353|144566334|OTHER||Geometric Mean Ratio|1.112|||||TWO_SIDED|90.0|0.948|1.303||||||||1.303|0.948|
72518220|NCT04682353|144566334|OTHER||Geometric Mean Ratio|1.439|||||TWO_SIDED|90.0|1.174|1.762||||||||1.762|1.174|
72518221|NCT04682353|144566334|OTHER||Geometric Mean Ratio|2.075|||||TWO_SIDED|90.0|1.751|2.459||||||||2.459|1.751|
72518222|NCT04682353|144566335|OTHER||Geometric Mean Ratio|1.115|||||TWO_SIDED|90.0|0.993|1.252||||||||1.252|0.993|
72518223|NCT04682353|144566335|OTHER||Geometric Mean Ratio|1.53|||||TWO_SIDED|90.0|1.277|1.833||||||||1.833|1.277|
72518224|NCT04682353|144566335|OTHER||Geometric Mean Ratio|2.14|||||TWO_SIDED|90.0|1.888|2.425||||||||2.425|1.888|
72518225|NCT04962503|144566352|OTHER|||||||0.0313||||||Change from baseline to Day 3|Wilcoxon (Mann-Whitney)|||||||0.0313
72518226|NCT04962503|144566352|OTHER|||||||0.0625||||||Change from baseline to Day 9|Wilcoxon (Mann-Whitney)|||||||0.0625
72518227|NCT01769469|144566361|OTHER|||||||0.2085|||||||Wilcoxon (Mann-Whitney)|||Test of difference at Week 48 from baseline||||0.2085
72624848|NCT01139515|144779127|SUPERIORITY_OR_OTHER_LEGACY||Adjusted ratio of geometric means|109.93|||||TWO_SIDED|90.0|102.65|117.72||||||Natural log transformed, dose-normalized AUC\[0- ∞\] of eletriptan was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||117.72|102.65|
72492838|NCT02025426|144514359|OTHER|||||||0.547|||||||Kruskal-Wallis|||||||0.547
72492839|NCT02025426|144514361|OTHER|||||||0.925|||||||Kruskal-Wallis|||||||0.925
72492840|NCT02025426|144514362|OTHER|||||||0.498|||||||Kruskal-Wallis|||||||0.498
72492841|NCT02025426|144514363|OTHER|||||||0.201|||||||Kruskal-Wallis|||||||0.201
72492842|NCT02025426|144514364|OTHER||||||>|0.999|||||||Fisher Exact|||||||>0.999
72492843|NCT02025426|144514365|OTHER|||||||0.962|||||||Fisher Exact|||||||0.962
72492844|NCT02025426|144514366|OTHER||||||>|0.999|||||||Fisher Exact|||||||>0.999
72492845|NCT00452699|144514381|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.11|||<|0.001||95.0|0.07|0.15|||ANCOVA|||||0.15|0.07|<0.001
72492846|NCT02111564|144514394|SUPERIORITY||Hazard Ratio (HR)|0.76||||0.136|TWO_SIDED|95.0|0.52|1.09|||Cox proportional hazards model|||||1.09|0.52|0.136
72492847|NCT02111564|144514395|SUPERIORITY||Hazard Ratio (HR)|1.88||||0.124|TWO_SIDED|95.0|0.84|4.23|||Cox proportional hazards model|||||4.23|0.84|0.124
72492848|NCT02111564|144514396|SUPERIORITY||Hazard Ratio (HR)|0.93||||0.751|TWO_SIDED|95.0|0.62|1.42|||Cox proportional hazards model|||||1.42|0.62|0.751
72492849|NCT02111564|144514397|SUPERIORITY||Hazard Ratio (HR)|0.44||||0.023|TWO_SIDED|95.0|0.22|0.89|||Cox proportional hazards model|||||0.89|0.22|0.023
72492850|NCT02111564|144514398|SUPERIORITY||Hazard Ratio (HR)|0.73||||0.033|TWO_SIDED|95.0|0.54|0.97|||Cox proportional hazards model|||||0.97|0.54|0.033
72492851|NCT02111564|144514399|SUPERIORITY||Hazard Ratio (HR)|0.78||||0.073|TWO_SIDED|95.0|0.6|1.02|||Cox proportional hazards model|||||1.02|0.60|0.073
72492852|NCT02111564|144514400|SUPERIORITY||Hazard Ratio (HR)|0.8||||0.156|TWO_SIDED|95.0|0.58|1.09|||Cox proportional hazards model|||||1.09|0.58|0.156
72492853|NCT02354703|144514402|SUPERIORITY|||||||0.94||||||a priori significance P\<0.05|Kruskal-Wallis|adjusted for baseline value||||||0.94
72492854|NCT02354703|144514403|SUPERIORITY|||||||1||||||a priori significance is P\<0.05|Chi-squared|adjusted for baseline value||||||1.00
72492855|NCT02354703|144514404|SUPERIORITY|||||||0.73||||||a priori threshold is P\<0.05|Kruskal-Wallis|adjusted for baseline value||||||0.73
72492856|NCT03468309|144514414|SUPERIORITY|T-test was used to compare means at baseline and 12-weeks|||||<|0.05|||||||t-test, 2 sided|||||||<0.05
72492857|NCT03468309|144514415|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
72492858|NCT03468309|144514416|SUPERIORITY||||||<|0.05|||||||ANOVA|Assumption of sphericity had been violated X2(2)=13.61, p\<.01 so Huynh-Feldt correction was used||||||<0.05
72492859|NCT03468309|144514417|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<0.05
72492860|NCT05726318|144514436|SUPERIORITY|||||||0.78|||||||Chi-squared|||||||.78
72492861|NCT05726318|144514438|SUPERIORITY|||||||0.78|||||||Chi-squared|||||||.78
72492862|NCT05726318|144514439|SUPERIORITY|||||||0.68|||||||Chi-squared|||||||.68
72492863|NCT05726318|144514441|SUPERIORITY|||||||0.78|||||||Chi-squared|||||||.78
72492864|NCT05726318|144514442|SUPERIORITY|||||||0.13|||||||Chi-squared|||||||0.13
72492865|NCT04589988|144514443|SUPERIORITY|||||||0.068||||||P value shown is for group by time interaction.|Mixed Models Analysis|||A linear mixed effects model was used to assess the effects of time (6-month follow-up versus baseline), group (REBIL versus control) and the interaction of group and time on the outcome. A significant interaction of group and time would indicate that the two groups had significantly different changes in the outcome over time. The model adjusted for age, sex, race, and depression score at baseline.||||0.068
72492866|NCT04589988|144514444|SUPERIORITY|||||||0.063||||||P value shown is for group by time interaction.|Mixed Models Analysis|||A linear mixed effects model was used to assess the effects of time (6-month follow-up versus baseline), group (REBIL versus control) and the interaction of group and time on the outcome. A significant interaction of group and time would indicate that the two groups had significantly different changes in the outcome over time. The model adjusted for age, sex, race, and depression score at baseline.||||0.063
72518228|NCT01769469|144566365|SUPERIORITY|||||||0.2452|||||||Wilcoxon Signed Rank Test|||||||0.2452
72518229|NCT01769469|144566373|SUPERIORITY|||||||0.0806|||||||Wilcoxon Signed Rank Test|||||||.0806
72518230|NCT01769469|144566384|OTHER|||||||0.6545|||||||Wilcoxon Signed Rank Test|||||||0.6545
72518231|NCT01769469|144566388|OTHER|||||||0.8739|||||||Wilcoxon Signed Rank Test|||||||0.8739
72518232|NCT01769469|144566396|OTHER|||||||0.5014|||||||Wilcoxon Signed Rank Test|||||||0.5014
72518233|NCT01769469|144566397|OTHER|||||||0.2431|||||||Wilcoxon Signed Rank Test|||||||0.2431
72518234|NCT01769469|144566398|OTHER|||||||0.7209|||||||Wilcoxon Signed Rank Test|||||||0.7209
72518235|NCT01769469|144566399|OTHER|||||||0.5379|||||||Wilcoxon Signed Rank Test|||||||0.5379
72518236|NCT01769469|144566400|OTHER|||||||0.7986|||||||Wilcoxon Signed Rank Test|||||||0.7986
72405401|NCT00559962|144318823|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.66|||<|0.001|TWO_SIDED|95.0|4.22|11.11||(All comparisons)|ANOVA|||One-way ANOVA to compare the absolute change from baseline to Week 12 in percent hepatic fat between active treatment groups and placebo||11.11|4.22|<0.001
72405402|NCT00559962|144318823|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.51|||<|0.001|TWO_SIDED|95.0|5.16|9.86||(All comparisons)|ANOVA|||One-way ANOVA to compare the absolute change from baseline to Week 12 in percent hepatic fat between active treatment groups and placebo||9.86|5.16|<0.001
72405403|NCT01479621|144318824|SUPERIORITY_OR_OTHER|||||||0.0001||||||The study was considered positive if the trend test was positive and the test involving the highest Fp MDPI dose (100 mcg twice daily) indicated significantly greater time averaged FEV1 mean than placebo.|Regression, Linear|||A linear in log-dose trend contrast evaluated the time-averaged dose-response trend, where the logarithm of dose was defined as log(dose+1) to accommodate the case of a zero dose (placebo). A fixed-sequence testing procedure was employed to control the overall Type I error rate at the 0.05 level. Specifically, the 2-sided linear in log-dose time-averaged trend test was first performed followed by pairwise comparisons of each Fp MDPI dose versus placebo.||||0.0001
72405404|NCT01479621|144318824|SUPERIORITY_OR_OTHER||LSM difference|0.149||||0.0005|TWO_SIDED|95.0|0.066|0.233||The study was considered positive if the trend test was positive and the test involving the highest Fp MDPI dose (100 mcg twice daily) indicated significantly greater time averaged FEV1 mean than placebo.|mixed model for repeated measures|||This is the second analysis in the fixed-sequence testing procedure employed to control the overall Type I error rate at the 0.05 level.||0.233|0.066|0.0005
72492867|NCT04589988|144514445|SUPERIORITY|||||||0.724||||||P value shown is for group by time interaction.|Mixed Models Analysis|||A linear mixed effects model was used to assess the effects of time (6-month follow-up versus baseline), group (REBIL versus control) and the interaction of group and time on the outcome. A significant interaction of group and time would indicate that the two groups had significantly different changes in the outcome over time. The model adjusted for age, sex, race, and depression score at baseline.||||0.724
72492868|NCT04589988|144514446|SUPERIORITY|||||||0.447||||||P value shown is for group by time interaction.|Mixed Models Analysis|||A linear mixed effects model was used to assess the effects of time (6-month follow-up versus baseline), group (REBIL versus control) and the interaction of group and time on the outcome. A significant interaction of group and time would indicate that the two groups had significantly different changes in the outcome over time. The model adjusted for age, sex, race, and depression score at baseline.||||0.447
72492869|NCT04589988|144514447|SUPERIORITY|||||||0.696||||||P value shown is for group by time interaction.|Mixed Models Analysis|||A linear mixed effects model was used to assess the effects of time (6-month follow-up versus baseline), group (REBIL versus control) and the interaction of group and time on the outcome. A significant interaction of group and time would indicate that the two groups had significantly different changes in the outcome over time. The model adjusted for age, sex, race, work status, and depression score at baseline.||||0.696
72492870|NCT04589988|144514448|SUPERIORITY|||||||0.798||||||P value shown is for group by time interaction.|Mixed Models Analysis|||A linear mixed effects model was used to assess the effects of time (6-month follow-up versus baseline), group (REBIL versus control) and the interaction of group and time on the outcome. A significant interaction of group and time would indicate that the two groups had significantly different changes in the outcome over time. The model adjusted for age, sex, race, and depression score at baseline.||||0.798
72492871|NCT04589988|144514449|SUPERIORITY|||||||0.135||||||P value shown is for group by time interaction.|Mixed Models Analysis|||A linear mixed effects model was used to assess the effects of time (6-month follow-up versus baseline), group (REBIL versus control) and the interaction of group and time on the outcome. A significant interaction of group and time would indicate that the two groups had significantly different changes in the outcome over time. The model adjusted for age, sex, race, and depression score at baseline.||||0.135
72492872|NCT04589988|144514450|SUPERIORITY|||||||0.291||||||P value shown is for group by time interaction.|Mixed Models Analysis|||A linear mixed effects model was used to assess the effects of time (6-month follow-up versus baseline), group (REBIL versus control) and the interaction of group and time on the outcome. A significant interaction of group and time would indicate that the two groups had significantly different changes in the outcome over time. The model adjusted for age, sex, race, work status, and depression score at baseline.||||0.291
72492873|NCT04589988|144514451|SUPERIORITY||Incidence rate ratio|0.83||||0.631|TWO_SIDED|95.0|0.4|1.76|||Negative binomial regression||IRR reflects REBIL intervention group versus control group.|Fall rates were compared between REBIL and control groups using negative binomial regression. The model adjusted for age, sex, ace, and depression score at baseline. The null hypothesis was that fall rates do not differ between groups.||1.76|0.40|0.631
72518237|NCT01769469|144566420|OTHER|||||||0.8507|||||||Wilcoxon Signed Rank Test|||||||0.8507
72518238|NCT01769469|144566421|OTHER|||||||0.3483|||||||Wilcoxon Signed Rank Test|||||||0.3483
72569539|NCT02944383|144669968|SUPERIORITY||Median Difference (Net)|-19.02||||0.0063|TWO_SIDED|95.0|-33.07|-4.25|||Ranked ANCOVA|Randomized treatment group \& randomized baseline statin (yes or no) are included as factors, \& outcome (ranked) at baseline is included as covariate.|Estimates generated from Hodges-Lehmann method.|||-4.25|-33.07|0.0063
72492874|NCT01081795|144514482|SUPERIORITY_OR_OTHER||Least Square (LS) mean difference|-0.4||||0.1646|TWO_SIDED|95.0|-1.0|0.2||Analysis of covariance (ANCOVA) method using the treatment group as the factor and using the value obtained during the baseline measurement period as the covariate was used.|ANCOVA|||||0.2|-1.0|0.1646
72518239|NCT01769469|144566428|OTHER|||||||0.4043|||||||Wilcoxon (Mann-Whitney)|||||||0.4043
72518240|NCT01769469|144566429|OTHER|||||||0.2927|||||||Wilcoxon (Mann-Whitney)|||||||0.2927
72518241|NCT01769469|144566430|OTHER|||||||0.1134|||||||Wilcoxon (Mann-Whitney)|||||||0.1134
72518242|NCT01769469|144566431|OTHER|||||||0.5782|||||||Wilcoxon (Mann-Whitney)|||||||0.5782
72518243|NCT01769469|144566432|OTHER|||||||0.8658|||||||Wilcoxon (Mann-Whitney)|||||||0.8658
72518244|NCT01769469|144566433|OTHER|||||||0.5491|||||||Wilcoxon (Mann-Whitney)|||||||0.5491
72518245|NCT01769469|144566434|OTHER|||||||0.0238|||||||Wilcoxon (Mann-Whitney)|||||||0.0238
72518246|NCT01769469|144566435|OTHER|||||||0.1172|||||||Wilcoxon (Mann-Whitney)|||||||0.1172
72569540|NCT02944383|144669968|SUPERIORITY||Median Difference (Net)|-7.63||||0.235|TWO_SIDED|95.0|-25.88|7.05|||Ranked ANCOVA|Randomized treatment group \& randomized baseline statin (yes or no) are included as factors, \& outcome (ranked) at baseline is included as covariate.|Estimates generated from Hodges-Lehmann method.|||7.05|-25.88|0.2350
72569541|NCT02944383|144669969|OTHER|||||||0.1663||||||Ranked ANCOVA results are obtained using a model where the outcome is ranked, randomized treatment group and randomized baseline statin (yes or no) are included as factors, and outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 2||||0.1663
72569542|NCT02944383|144669969|SUPERIORITY|||||||0.6195||||||Ranked ANCOVA results are obtained using a model where the outcome is ranked, randomized treatment group and randomized baseline statin (yes or no) are included as factors, and outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 2||||0.6195
72569543|NCT02944383|144669969|SUPERIORITY|||||||0.0436||||||Ranked ANCOVA results are obtained using a model where the outcome is ranked, randomized treatment group and randomized baseline statin (yes or no) are included as factors, and outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 6||||0.0436
72569544|NCT02944383|144669969|SUPERIORITY|||||||0.5||||||Ranked ANCOVA results are obtained using a model where the outcome is ranked, randomized treatment group and randomized baseline statin (yes or no) are included as factors, and outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 6||||0.5000
72569545|NCT02944383|144669969|SUPERIORITY|||||||0.0007||||||Ranked ANCOVA results are obtained using a model where the outcome is ranked, randomized treatment group and randomized baseline statin (yes or no) are included as factors, and outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.0007
72518247|NCT01769469|144566436|OTHER|||||||0.122|||||||Wilcoxon (Mann-Whitney)|||||||0.1220
72518248|NCT01769469|144566437|OTHER|||||||1|||||||Wilcoxon (Mann-Whitney)|||||||1.000
72518249|NCT01769469|144566439|OTHER|||||||0.7785|||||||Wilcoxon (Mann-Whitney)|||||||0.7785
72518250|NCT01769469|144566440|OTHER|||||||0.4933|||||||Wilcoxon (Mann-Whitney)|||||||0.4933
72518251|NCT01769469|144566441|OTHER|||||||0.5491|||||||Wilcoxon (Mann-Whitney)|||||||0.5491
72518252|NCT01769469|144566442|OTHER|||||||0.5161|||||||Wilcoxon (Mann-Whitney)|||||||0.5161
72518253|NCT01769469|144566443|OTHER|||||||0.599|||||||Wilcoxon (Mann-Whitney)|||||||0.5990
72569546|NCT02944383|144669969|SUPERIORITY|||||||0.1161||||||Ranked ANCOVA results are obtained using a model where the outcome is ranked, randomized treatment group and randomized baseline statin (yes or no) are included as factors, and outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.1161
72569547|NCT02944383|144669969|SUPERIORITY|||||||0.183||||||Ranked ANCOVA results are obtained using a model where the outcome is ranked, randomized treatment group and randomized baseline statin (yes or no) are included as factors, and outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.1830
72569548|NCT02944383|144669969|SUPERIORITY|||||||0.8762||||||Ranked ANCOVA results are obtained using a model where the outcome is ranked, randomized treatment group and randomized baseline statin (yes or no) are included as factors, and outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.8762
72569549|NCT02944383|144669970|SUPERIORITY|||||||0.178||||||Ranked ANCOVA results are obtained using a model where the outcome is ranked, randomized treatment group and randomized baseline statin (yes or no) are included as factors, and outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 2||||0.1780
72624849|NCT01139515|144779128|SUPERIORITY_OR_OTHER_LEGACY||Adjusted geometric means ratio|99.41|||||TWO_SIDED|90.0|92.97|106.31||||||Natural log transformed, dose-normalized AUClast of eletriptan was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||106.31|92.97|
72624850|NCT01139515|144779128|SUPERIORITY_OR_OTHER_LEGACY||Adjusted ratio of geometric means|110.52|||||TWO_SIDED|90.0|103.36|118.18||||||Natural log transformed, dose-normalized AUClast of eletriptan was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||118.18|103.36|
72518254|NCT01769469|144566444|OTHER|||||||0.8579|||||||Wilcoxon (Mann-Whitney)|||||||0.8579
72518255|NCT01769469|144566445|OTHER|||||||0.0719|||||||Wilcoxon (Mann-Whitney)|||||||0.0719
72518256|NCT01769469|144566446|OTHER|||||||0.3148|||||||Wilcoxon (Mann-Whitney)|||||||0.3148
72518257|NCT01769469|144566447|OTHER|||||||0.139|||||||Wilcoxon (Mann-Whitney)|||||||0.1390
72518258|NCT01769469|144566448|OTHER|||||||0.2726|||||||Wilcoxon (Mann-Whitney)|||||||0.2726
72518259|NCT01769469|144566449|OTHER|||||||0.537|||||||Wilcoxon (Mann-Whitney)|||||||0.5370
72518260|NCT01769469|144566450|OTHER|||||||0.2926|||||||Wilcoxon (Mann-Whitney)|||||||0.2926
72518261|NCT01769469|144566451|OTHER|||||||0.1906|||||||Wilcoxon (Mann-Whitney)|||||||0.1906
72518262|NCT01769469|144566452|OTHER|||||||0.2255|||||||Wilcoxon (Mann-Whitney)|||||||0.2255
72518263|NCT01769469|144566453|OTHER|||||||0.6285|||||||Wilcoxon (Mann-Whitney)|||||||0.6285
72518264|NCT01769469|144566454|OTHER|||||||0.0148|||||||Wilcoxon (Mann-Whitney)|||||||0.0148
72518265|NCT01769469|144566455|OTHER|||||||0.0166|||||||Wilcoxon (Mann-Whitney)|||||||0.0166
72518266|NCT01769469|144566456|OTHER|||||||0.0277|||||||Wilcoxon (Mann-Whitney)|||||||0.0277
72518267|NCT01769469|144566457|OTHER|||||||0.261|||||||Wilcoxon (Mann-Whitney)|||||||0.2610
72518268|NCT01769469|144566458|OTHER|||||||0.4154|||||||Wilcoxon (Mann-Whitney)|||||||0.4154
72518269|NCT01769469|144566459|OTHER|||||||0.7125|||||||Wilcoxon (Mann-Whitney)|||||||0.7125
72518270|NCT00862654|144566485|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.01|TWO_SIDED|95.0|||||Cochran-Mantel-Haenszel|Each test was two-sided, at the 0.050 significance level.||The primary efficacy criterion was analyzed by using the Cochran-Mantel-Haenszel (CMH) statistic, stratified by center (or analysis-center) after ridit transformation with the row mean difference statistics, testing the hypothesis of equality. The p-value had to be inferior to 0.05 at week 4, in the ITT/LOCF population. PP analysis was also performed to assess the robustness of the results obtained in the ITT/LOCF population.||||<0.01
72405405|NCT01479621|144318824|SUPERIORITY_OR_OTHER||LSM difference|0.126||||0.0027|TWO_SIDED|95.0|0.044|0.208|||mixed model for repeated measures|||This is the third analysis in the fixed-sequence testing procedure employed to control the overall Type I error rate at the 0.05 level.||0.208|0.044|0.0027
72492875|NCT01081795|144514482|SUPERIORITY_OR_OTHER||LS mean difference|-0.2||||0.4479|TWO_SIDED|95.0|-0.8|0.4||ANCOVA method using the treatment group as the factor and using the value obtained during the baseline measurement period as the covariate was used.|ANCOVA|||||0.4|-0.8|0.4479
72492876|NCT01081795|144514483|SUPERIORITY_OR_OTHER||LS mean difference|-0.5||||0.1547|TWO_SIDED|95.0|-1.1|0.2||Month 6: ANCOVA method using the treatment group as the factor and using the value obtained during the baseline measurement period as the covariate was used.|ANCOVA|||||0.2|-1.1|0.1547
72492877|NCT01081795|144514483|SUPERIORITY_OR_OTHER||LS mean difference|-0.4||||0.2624|TWO_SIDED|95.0|-1.0|0.3||Month 6: ANCOVA method using the treatment group as the factor and using the value obtained during the baseline measurement period as the covariate was used.|ANCOVA|||||0.3|-1.0|0.2624
72518271|NCT00862654|144566485|SUPERIORITY_OR_OTHER_LEGACY|||||||0.039||95.0|||||Cochran-Mantel-Haenszel|Each test was two-sided, at the 0.050 significance level.||The primary efficacy criterion was analyzed by using the Cochran-Mantel-Haenszel (CMH) statistic, stratified by center (or analysis-center) after ridit transformation with the row mean difference statistics, testing the hypothesis of equality. The p-value had to be inferior to 0.05 at week 4, in the ITT/LOCF population. PP analysis was also performed to assess the robustness of the results obtained in the ITT/LOCF population.||||0.039
72518272|NCT01617187|144566551|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) means difference|-1.3|STANDARD_ERROR_OF_MEAN|2.46||0.6043|TWO_SIDED|95.0|-6.1|3.6||Adjusted p-value from graphical approach to control Type 1 error rate among primary and secondary efficacy hypotheses|Mixed Model Repeated Measures (MMRM)||Asenapine 2.5 mg BID minus Placebo BID|||3.6|-6.1|0.6043
72518273|NCT01617187|144566551|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-5.5|STANDARD_ERROR_OF_MEAN|2.32||0.0356|TWO_SIDED|95.0|-10.1|-1.0||Adjusted p-value from graphical approach to control Type 1 error rate among primary and secondary efficacy hypotheses|MMRM||Asenapine 5 mg BID minus Placebo BID|||-1.0|-10.1|0.0356
72518274|NCT01617187|144566551|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-5.4|STANDARD_ERROR_OF_MEAN|2.86||0.0587|TWO_SIDED|95.0|-11.1|0.2||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|||0.2|-11.1|0.0587
72518275|NCT01617187|144566552|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.0|STANDARD_ERROR_OF_MEAN|0.15||0.9083|TWO_SIDED|95.0|-0.3|0.3||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Confirmative testing of asenapine versus placebo for this measure was to be performed only if both asenapine doses were statistically superior to placebo in reduction from baseline in PANSS Total Score (Primary outcome measure)||0.3|-0.3|0.9083
72518276|NCT01617187|144566552|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.3|STANDARD_ERROR_OF_MEAN|0.14||0.0601|TWO_SIDED|95.0|-0.6|0.0||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Confirmative testing of asenapine versus placebo for this measure was to be performed only if both asenapine doses were statistically superior to placebo in reduction from baseline in PANSS Total Score (Primary outcome measure)||0.0|-0.6|0.0601
72518277|NCT01617187|144566552|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.2|STANDARD_ERROR_OF_MEAN|0.18||0.3898|TWO_SIDED|95.0|-0.5|0.2||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|||0.2|-0.5|0.3898
72518278|NCT01617187|144566553|SUPERIORITY_OR_OTHER_LEGACY|||||||0.37||||||P-value from Cochran Mantel-Haenszel test with an adjustment for pooled center|Cochran-Mantel-Haenszel|||Confirmative testing of asenapine versus placebo for this measure was to be performed only if both asenapine doses were statistically superior to placebo in reduction from baseline in PANSS Total Score (Primary outcome measure)||||0.3700
72518279|NCT01617187|144566553|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1708||||||P-value from Cochran Mantel-Haenszel test with an adjustment for pooled center|Cochran-Mantel-Haenszel|||Confirmative testing of asenapine versus placebo for this measure was to be performed only if both asenapine doses were statistically superior to placebo in reduction from baseline in PANSS Total Score (Primary outcome measure)||||0.1708
72518280|NCT01617187|144566553|SUPERIORITY_OR_OTHER_LEGACY|||||||0.262||||||P-value from Cochran Mantel-Haenszel test with an adjustment for pooled center|Cochran-Mantel-Haenszel|||||||0.2620
72518281|NCT01617187|144566554|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-1.2|STANDARD_ERROR_OF_MEAN|0.6||0.0491|TWO_SIDED|95.0|-2.4|0.0||p-value adjusted for multiple comparisons using Hochberg's method|MMRM||Asenapine 2.5 mg BID minus Olanzapine 15 mg QD|||-0.0|-2.4|0.0491
72518282|NCT01617187|144566554|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-1.2|STANDARD_ERROR_OF_MEAN|0.57||0.0491|TWO_SIDED|95.0|-2.3|0.0||p-value adjusted for multiple comparisons using Hochberg's method|MMRM||Asenapine 5 mg BID minus Olanzapine 15 mg QD|||-0.0|-2.3|0.0491
72405406|NCT01479621|144318824|SUPERIORITY_OR_OTHER||LSM difference|0.111||||0.0086|TWO_SIDED|95.0|0.028|0.194|||mixed model for repeated measures|||This is the fourth analysis in the fixed-sequence testing procedure employed to control the overall Type I error rate at the 0.05 level.||0.194|0.028|0.0086
72492878|NCT01081795|144514484|SUPERIORITY_OR_OTHER||LS mean difference|-0.4||||0.2464|TWO_SIDED|95.0|-1.0|0.3||Month 6: ANCOVA method using the treatment group as the factor and using the value obtained during the baseline measurement period as the covariate was used.|ANCOVA|||||0.3|-1.0|0.2464
72492879|NCT01081795|144514484|SUPERIORITY_OR_OTHER||LS mean difference|-0.3||||0.3148|TWO_SIDED|95.0|-1.0|0.3||Month 6: ANCOVA method using the treatment group as the factor and using the value obtained during the baseline measurement period as the covariate was used.|ANCOVA|||||0.3|-1.0|0.3148
72492880|NCT01081795|144514485|SUPERIORITY_OR_OTHER||LS mean difference|0.0||||0.8762|TWO_SIDED|95.0|-0.6|0.5||Month 6: ANCOVA method using the treatment group as the factor and using the value obtained during the baseline measurement period as the covariate was used.|ANCOVA|||||0.5|-0.6|0.8762
72492881|NCT01081795|144514485|SUPERIORITY_OR_OTHER||LS mean difference|-0.3||||0.3031|TWO_SIDED|95.0|-0.8|0.3||Month 6: ANCOVA method using the treatment group as the factor and using the value obtained during the baseline measurement period as the covariate was used.|ANCOVA|||||0.3|-0.8|0.3031
72518283|NCT01617187|144566554|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|1.0|STANDARD_ERROR_OF_MEAN|0.51||0.0567|TWO_SIDED|95.0|0.0|2.0||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|||2.0|-0.0|0.0567
72518284|NCT01617187|144566554|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|1.0|STANDARD_ERROR_OF_MEAN|0.48||0.0391|TWO_SIDED|95.0|0.0|1.9||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|||1.9|0.0|0.0391
72492882|NCT01081795|144514486|SUPERIORITY_OR_OTHER||LS mean difference|-0.3||||0.1145|TWO_SIDED|95.0|-0.7|0.1||Month 6: ANCOVA method using the treatment group as the factor and using the value obtained during the baseline measurement period as the covariate was used.|ANCOVA|||||0.1|-0.7|0.1145
72492883|NCT01081795|144514486|SUPERIORITY_OR_OTHER||LS mean difference|-0.2||||0.3971|TWO_SIDED|95.0|-0.6|0.2||Month 6: ANCOVA method using the treatment group as the factor and using the value obtained during the baseline measurement period as the covariate was used.|ANCOVA|||||0.2|-0.6|0.3971
72518285|NCT01617187|144566554|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|2.2|STANDARD_ERROR_OF_MEAN|0.58||0.0003|TWO_SIDED|95.0|1.0|3.3||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|||3.3|1.0|0.0003
72518286|NCT01617187|144566555|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.8|STANDARD_ERROR_OF_MEAN|1.09||0.4849|TWO_SIDED|95.0|-1.4|2.9||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 4||2.9|-1.4|0.4849
72518287|NCT01617187|144566555|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.1|STANDARD_ERROR_OF_MEAN|1.06||0.8902|TWO_SIDED|95.0|-2.2|1.9||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 4||1.9|-2.2|0.8902
72518288|NCT01617187|144566555|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.8|STANDARD_ERROR_OF_MEAN|1.36||0.5826|TWO_SIDED|95.0|-3.4|1.9||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 4||1.9|-3.4|0.5826
72518289|NCT01617187|144566555|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.1|STANDARD_ERROR_OF_MEAN|1.61||0.9271|TWO_SIDED|95.0|-3.3|3.0||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 7||3.0|-3.3|0.9271
72518290|NCT01617187|144566555|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-2.0|STANDARD_ERROR_OF_MEAN|1.56||0.1902|TWO_SIDED|95.0|-5.1|1.0||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 7||1.0|-5.1|0.1902
72518291|NCT01617187|144566555|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-2.2|STANDARD_ERROR_OF_MEAN|2.0||0.271|TWO_SIDED|95.0|-6.2|1.7||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 7||1.7|-6.2|0.2710
72624851|NCT01139515|144779128|SUPERIORITY_OR_OTHER_LEGACY||Adjusted ratio of geometric means|110.44|||||TWO_SIDED|90.0|103.28|118.09||||||Natural log transformed, dose-normalized AUClast of eletriptan was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||118.09|103.28|
72492884|NCT01081795|144514487|SUPERIORITY_OR_OTHER||LS mean difference|-0.5||||0.1866|TWO_SIDED|95.0|-1.3|0.3||ANCOVA method using the treatment group as the factor and using the value obtained during the baseline measurement period as the covariate was used.|ANCOVA|||||0.3|-1.3|0.1866
72492885|NCT01081795|144514487|SUPERIORITY_OR_OTHER||LS mean difference|-0.6||||0.1507|TWO_SIDED|95.0|-1.4|0.2||ANCOVA method using the treatment group as the factor and using the value obtained during the baseline measurement period as the covariate was used.|ANCOVA|||||0.2|-1.4|0.1507
72492886|NCT01081795|144514489|SUPERIORITY_OR_OTHER||LS mean difference|-0.4||||0.1743|TWO_SIDED|95.0|-1.0|0.2||ANCOVA method using the treatment group as the factor and using the value obtained during the baseline measurement period as the covariate was used.|ANCOVA|||||0.2|-1.0|0.1743
72492887|NCT01081795|144514489|SUPERIORITY_OR_OTHER||LS mean difference|-0.4||||0.2165|TWO_SIDED|95.0|-1.0|0.2||ANCOVA method using the treatment group as the factor and using the value obtained during the baseline measurement period as the covariate was used.|ANCOVA|||||0.2|-1.0|0.2165
72492888|NCT01081795|144514490|SUPERIORITY_OR_OTHER||Percentage difference|5.1||||0.3083|TWO_SIDED|95.0|-3.8|14.0||Month 6|Fisher Exact|||||14.0|-3.8|0.3083
72492889|NCT01081795|144514490|SUPERIORITY_OR_OTHER||Percentage difference|2.0||||0.7235|TWO_SIDED|95.0|-6.6|10.6||Month 6|Fisher Exact|||||10.6|-6.6|0.7235
72492890|NCT01707693|144514494|SUPERIORITY|repeated measures mixed model analysis of covariance, with the baseline measurement as a covariate.||||||0.023||||||P-value calculated from repeated measures model adjusting for age with a log transformation applied. P-values are one-sided.|ANCOVA|||||||0.023
72492891|NCT01707693|144514495|SUPERIORITY|||||||0.011||||||\* P-value calculated from repeated measures model adjusting for age with a log transformation applied.|ANCOVA|\* P-value calculated from repeated measures model adjusting for age with a log transformation applied.||||||0.011
72492892|NCT01707693|144514496|OTHER|2-sided Wilcoxon Rank Sum test||||||0.033|||||||Wilcoxon (Mann-Whitney)|||||||0.033
72492893|NCT01707693|144514497|OTHER|counts of stage of change||||||0.001|||||||Cochran-Mantel-Haenszel|2-sided Cochran-Armitage trend test||||||.001
72624852|NCT01139515|144779129|SUPERIORITY_OR_OTHER_LEGACY||Adjusted geometric means ratio|101.81|||||TWO_SIDED|90.0|85.97|120.58||||||"Natural log transformed, dose-normalized Cmax of eletriptan was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.~The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios."||120.58|85.97|
72492894|NCT00143455|144514498|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.236||||0.0556||95.0|0.995|1.536|||Cox Proportional Hazard Model|||A non-inferiority test was combined with a superiority test based on a closed testing procedure. The null hypothesis was to be rejected if the lower bound of the 2-sided 95% confidence interval for the hazard ratio (control/test) estimated from a Cox proportional hazards model, with an indicator for the control arm, was less than 0.80.||1.536|0.995|0.0556
72492895|NCT00143455|144514499|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.343||||0.143||95.0|0.905|1.993|||Chi-squared|||||1.993|0.905|0.143
72518292|NCT01617187|144566555|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.7|STANDARD_ERROR_OF_MEAN|1.79||0.6773|TWO_SIDED|95.0|-2.8|4.3||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 14||4.3|-2.8|0.6773
72518293|NCT01617187|144566555|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-1.8|STANDARD_ERROR_OF_MEAN|1.72||0.2895|TWO_SIDED|95.0|-5.2|1.6||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 14||1.6|-5.2|0.2895
72518294|NCT01617187|144566555|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-1.7|STANDARD_ERROR_OF_MEAN|2.18||0.4261|TWO_SIDED|95.0|-6.0|2.6||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 14||2.6|-6.0|0.4261
72518295|NCT01617187|144566555|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|1.3|STANDARD_ERROR_OF_MEAN|2.13||0.5505|TWO_SIDED|95.0|-2.9|5.5||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 21||5.5|-2.9|0.5505
72492896|NCT00143455|144514500|NON_INFERIORITY_OR_EQUIVALENCE|A non-inferiority test was combined with a superiority test based on a closed testing procedure. The null hypothesis was to be rejected if the lower bound of the 2-sided 95% confidence interval for the hazard ratio (control/test) estimated from a Cox proportional hazards model, with an indicator for the control arm, was less than 0.80.|Hazard Ratio (HR)|1.35||||0.011||95.0|1.071|1.701|||Cox Proportional Hazard Model|||||1.701|1.071|0.0110
72492897|NCT00143455|144514501|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.354||||0.0831||95.0|0.961|1.908|||Cox Proportional Hazard Model|||||1.908|0.961|0.0831
72492898|NCT00143455|144514502|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.965||||0.7544||95.0|0.771|1.208|||Cox Proportional Hazard Model|||||1.208|0.771|0.7544
72492899|NCT00419380|144514513|SUPERIORITY_OR_OTHER|||||||0.36|TWO_SIDED||||||Chi-squared|||Two by two contingency table was used to compare our outcome, tube patency yes/no, by our two independent variables, dornase alfa (Pulmozyme®) and Ofloxin.||||.36
72492900|NCT00419380|144514514|SUPERIORITY_OR_OTHER|||||||0.26|TWO_SIDED|||||Two by two contingency table was used to compare our outcome, presence/absence of ear drainage, by our two independent variables, dornase alfa (Pulmozyme®) and Ofloxin.|Chi-squared|||||||.26
72492901|NCT03099707|144514515|SUPERIORITY||Risk Ratio (RR)|5.2||||0.105|TWO_SIDED|95.0|0.6|43.0|||Fisher Exact|||||43|0.6|0.105
72492902|NCT03861559|144514536|OTHER||||||<|0.01|||||||Log Rank|||||||<0.01
72492903|NCT03861559|144514537|OTHER||||||<|0.01|||||||ANOVA|||||||<0.01
72492904|NCT03861559|144514539|OTHER||||||<|0.01|||||||ANOVA|||||||<0.01
72492905|NCT03861559|144514540|OTHER||||||<|0.01|||||||ANOVA|||||||<0.01
72492906|NCT03861559|144514541|OTHER||||||<|0.01|||||||ANOVA|||||||<0.01
72492907|NCT03861559|144514543|OTHER|||||||0.14|||||||ANOVA|||||||0.14
72492908|NCT03861559|144514544|OTHER|||||||0.02|||||||ANOVA|||||||0.02
72492909|NCT03861559|144514545|OTHER||||||<|0.01|||||||ANOVA|||||||<0.01
72492910|NCT03861559|144514547|OTHER|||||||0.15|||||||ANOVA|||||||0.15
72492911|NCT03861559|144514548|OTHER||||||<|0.01|||||||ANOVA|||||||<0.01
72492912|NCT03861559|144514549|OTHER||||||<|0.01|||||||ANOVA|||||||<0.01
72492913|NCT03861559|144514551|OTHER||||||<|0.01|||||||ANOVA|||||||<0.01
72492914|NCT03861559|144514552|OTHER||||||<|0.01|||||||ANOVA|||||||<0.01
72492915|NCT03861559|144514553|OTHER||||||<|0.01|||||||ANOVA|||||||<0.01
72492916|NCT03861559|144514554|OTHER||||||<|0.01|||||||ANOVA|||||||<0.01
72492917|NCT03861559|144514555|OTHER||||||<|0.01|||||||ANOVA|||||||<0.01
72492918|NCT03861559|144514556|OTHER||||||<|0.01|||||||ANOVA|||||||<0.01
72492919|NCT00487539|144514561|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Chi-squared|||||||<0.0001
72492920|NCT00487539|144514561|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Chi-squared|||||||<0.0001
72492921|NCT00487539|144514562|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Chi-squared|||||||<0.0001
72492922|NCT00487539|144514562|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Chi-squared|||||||<0.0001
72492923|NCT00487539|144514563|SUPERIORITY_OR_OTHER|||||||0.0014|||||||Chi-squared|||||||0.0014
72492924|NCT00487539|144514563|SUPERIORITY_OR_OTHER|||||||0.0001|||||||Chi-squared|||||||0.0001
72492925|NCT00487539|144514564|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|on the van der Waerden normal scores||||||<0.0001
72492926|NCT00487539|144514564|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|on the van der Waerden normal scores||||||<0.0001
72492927|NCT01437397|144514565|SUPERIORITY_OR_OTHER||Least squares mean difference|0.108|STANDARD_ERROR_OF_MEAN|0.018|<|0.0001|TWO_SIDED|95.0|0.073|0.144|||Mixed Models Analysis|Treatment, sex, smoking-status, visit and group-by-visit as factors; screening pre- and post-bronchodilator FEV1, age and baseline FEV1 as covariates||||0.144|0.073|<0.0001
72492928|NCT01437397|144514565|SUPERIORITY_OR_OTHER||Least squares mean difference|0.087|STANDARD_ERROR_OF_MEAN|0.018|<|0.0001|TWO_SIDED|95.0|0.052|0.123|||Mixed Models Analysis|Treatment, sex, smoking-status, visit and group-by-visit as factors; screening pre- and post-bronchodilator FEV1, age and baseline FEV1 as covariates||||0.123|0.052|<0.0001
72492929|NCT01437397|144514566|SUPERIORITY_OR_OTHER||Least squares mean difference|0.045|STANDARD_ERROR_OF_MEAN|0.017||0.01|TWO_SIDED|95.0|0.011|0.079|||Mixed Models Analysis|Treatment, sex, smoking-status, visit and group-by-visit as factors; screening pre- and post-bronchodilator FEV1, age and baseline FEV1 as covariates||||0.079|0.011|0.010
72492930|NCT01437397|144514566|SUPERIORITY_OR_OTHER||Least squares mean difference|0.026|STANDARD_ERROR_OF_MEAN|0.017||0.133|TWO_SIDED|95.0|-0.008|0.06|||Mixed Models Analysis|Treatment, sex, smoking-status, visit and group-by-visit as factors; screening pre- and post-bronchodilator FEV1, age and baseline FEV1 as covariates||||0.060|-0.008|0.133
72492931|NCT01437397|144514567|SUPERIORITY_OR_OTHER||Least squares mean difference|1.436|STANDARD_ERROR_OF_MEAN|0.297|<|0.0001|TWO_SIDED|95.0|0.854|2.018|||Mixed Models Analysis|Treatment group, sex, smoking-status, visit, and treatment group-by-visit as factors; visit, age baseline BDI/SGRQ as covariates||||2.018|0.854|<0.0001
72492932|NCT01437397|144514567|SUPERIORITY_OR_OTHER||Least squares mean difference|1.395|STANDARD_ERROR_OF_MEAN|0.294|<|0.0001|TWO_SIDED|95.0|0.818|1.972|||Mixed Models Analysis|Treatment group, sex, smoking-status, visit, and treatment group-by-visit as factors; visit, age baseline BDI/SGRQ as covariates||||1.972|0.818|<0.0001
72492933|NCT01437397|144514568|SUPERIORITY_OR_OTHER||Least squares mean difference|-4.353|STANDARD_ERROR_OF_MEAN|1.075|<|0.0001|TWO_SIDED|95.0|-6.462|-2.244|||Mixed Models Analysis|Treatment group, sex, smoking-status, visit, and treatment group-by-visit as factors; visit, age baseline BDI/SGRQ as covariates||||-2.244|-6.462|<0.0001
72492934|NCT01437397|144514568|SUPERIORITY_OR_OTHER||Least squares mean difference|-3.728|STANDARD_ERROR_OF_MEAN|1.066||0.0005|TWO_SIDED|95.0|-5.819|-1.637|||Mixed Models Analysis|Treatment group, sex, smoking-status, visit, and treatment group-by-visit as factors; visit, age baseline BDI/SGRQ as covariates||||-1.637|-5.819|0.0005
72492935|NCT01687712|144514569|NON_INFERIORITY|Non-inferiority was demonstrated if the upper limit of the two-sided 95% CI of the difference in pregnancy rates (Gonal-f® RFF - AFOLIA) did not exceed 8% (i.e. a one-sided hypothesis test at the 2.5% level of significance). The difference in rates (\& Wald CI) was estimated using a logistic regression model with binomial distribution and identity link, with treatment and site as factors.|Risk Difference (RD)|3.7|||||TWO_SIDED|95.0|-1.3|8.7|||||"Note that risk in this context is the risk of clinical pregnancy. The difference is in the direction Gonal-f® RFF - AFOLIA."|"The null and alternative hypotheses are as follows:~H0: p2- p1 \> ∆ and H1: p2- p1 ≤ ∆,~where p1 is the clinical pregnancy rate in the AFOLIA treatment group, p2 is the clinical pregnancy rate in the Gonal f® treatment group, and Δ is the non-inferiority margin of 8%."||8.7|-1.3|
72492936|NCT01687712|144514570|NON_INFERIORITY|Non-inferiority was demonstrated if the upper limit of the two-sided 95% CI of the difference in pregnancy rates (Gonal-f® RFF - AFOLIA) did not exceed 8% (i.e. a one-sided hypothesis test at the 2.5% level of significance). The difference in rates (\& Wald CI) was estimated using a logistic regression model with binomial distribution and identity link, with treatment and site as factors.|Risk Difference (RD)|2.8|||||TWO_SIDED|95.0|-2.5|8.1|||||"Note that risk in this context is the risk of clinical pregnancy. The difference is in the direction Gonal-f® RFF - AFOLIA."|"The null and alternative hypotheses are as follows:~H0: p2- p1 \> ∆ and H1: p2- p1 ≤ ∆,~where p1 is the clinical pregnancy rate in the AFOLIA treatment group, p2 is the clinical pregnancy rate in the Gonal f® treatment group, and Δ is the non-inferiority margin of 8%."||8.1|-2.5|
72518296|NCT01617187|144566555|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-1.6|STANDARD_ERROR_OF_MEAN|2.03||0.4286|TWO_SIDED|95.0|-5.6|2.4||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 21||2.4|-5.6|0.4286
72518297|NCT01617187|144566555|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-2.0|STANDARD_ERROR_OF_MEAN|2.56||0.4423|TWO_SIDED|95.0|-7.0|3.1||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 21||3.1|-7.0|0.4423
72518298|NCT01617187|144566555|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|3.2|STANDARD_ERROR_OF_MEAN|2.3||0.1691|TWO_SIDED|95.0|-1.4|7.7||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 28||7.7|-1.4|0.1691
72518299|NCT01617187|144566555|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-1.6|STANDARD_ERROR_OF_MEAN|2.17||0.4682|TWO_SIDED|95.0|-5.8|2.7||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 28||2.7|-5.8|0.4682
72518300|NCT01617187|144566555|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-1.8|STANDARD_ERROR_OF_MEAN|2.71||0.4961|TWO_SIDED|95.0|-7.2|3.5||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 28||3.5|-7.2|0.4961
72518301|NCT01617187|144566555|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-1.6|STANDARD_ERROR_OF_MEAN|2.26||0.4697|TWO_SIDED|95.0|-6.1|2.8||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 35||2.8|-6.1|0.4697
72518302|NCT01617187|144566555|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-3.6|STANDARD_ERROR_OF_MEAN|2.14||0.0947|TWO_SIDED|95.0|-7.8|0.6||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 35||0.6|-7.8|0.0947
72518303|NCT01617187|144566555|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-4.9|STANDARD_ERROR_OF_MEAN|2.68||0.0675|TWO_SIDED|95.0|-10.2|0.4||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 35||0.4|-10.2|0.0675
72518304|NCT01617187|144566556|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1736||||||P-value from Cochran Mantel-Haenszel test with an adjustment for pooled center|Cochran-Mantel-Haenszel|||Day 4||||0.1736
72518305|NCT01617187|144566556|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1736||||||P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center|Cochran-Mantel-Haenszel|||Day 4||||0.1736
72518306|NCT01617187|144566556|SUPERIORITY_OR_OTHER_LEGACY|||||||0.285||||||P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center|Cochran-Mantel-Haenszel|||Day 4||||0.2850
72518307|NCT01617187|144566556|SUPERIORITY_OR_OTHER_LEGACY|||||||0.329||||||P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center|Cochran-Mantel-Haenszel|||Day 7||||0.3290
72518308|NCT01617187|144566556|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6938||||||P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center|Cochran-Mantel-Haenszel|||Day 7||||0.6938
72518309|NCT01617187|144566556|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1105||||||P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center|Cochran-Mantel-Haenszel|||Day 7||||0.1105
72518310|NCT01617187|144566556|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6804||||||P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center|Cochran-Mantel-Haenszel|||Day 14||||0.6804
72518311|NCT01617187|144566556|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9704||||||P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center|Cochran-Mantel-Haenszel|||Day 14||||0.9704
72518312|NCT01617187|144566556|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6604||||||P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center|Cochran-Mantel-Haenszel|||Day 14||||0.6604
72518313|NCT01617187|144566556|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2447||||||P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center|Cochran-Mantel-Haenszel|||Day 21||||0.2447
72518314|NCT01617187|144566556|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4834||||||P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center|Cochran-Mantel-Haenszel|||Day 21||||0.4834
72518315|NCT01617187|144566556|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9189||||||P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center|Cochran-Mantel-Haenszel|||Day 21||||0.9189
72518316|NCT01617187|144566556|SUPERIORITY_OR_OTHER_LEGACY|||||||0.437||||||P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center|Cochran-Mantel-Haenszel|||Day 28||||0.4370
72518317|NCT01617187|144566556|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2894||||||P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center|Cochran-Mantel-Haenszel|||Day 28||||0.2894
72518318|NCT01617187|144566556|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6953||||||P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center|Cochran-Mantel-Haenszel|||Day 28||||0.6953
72518319|NCT01617187|144566556|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4892||||||P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center|Cochran-Mantel-Haenszel|||Day 35||||0.4892
72518320|NCT01617187|144566556|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1954||||||P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center|Cochran-Mantel-Haenszel|||Day 35||||0.1954
72518321|NCT01617187|144566556|SUPERIORITY_OR_OTHER_LEGACY|||||||0.799||||||P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center|Cochran-Mantel-Haenszel|||Day 35||||0.7990
72518322|NCT01617187|144566557|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.1|STANDARD_ERROR_OF_MEAN|0.07||0.4255|TWO_SIDED|95.0|-0.1|0.2||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 4||0.2|-0.1|0.4255
72518323|NCT01617187|144566557|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.0|STANDARD_ERROR_OF_MEAN|0.06||0.9564|TWO_SIDED|95.0|-0.1|0.1||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 4||0.1|-0.1|0.9564
72518324|NCT01617187|144566557|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.0|STANDARD_ERROR_OF_MEAN|0.08||0.6363|TWO_SIDED|95.0|-0.2|0.1||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 4||0.1|-0.2|0.6363
72518325|NCT01617187|144566557|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.0|STANDARD_ERROR_OF_MEAN|0.1||0.8759|TWO_SIDED|95.0|-0.2|0.2||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 7||0.2|-0.2|0.8759
72569550|NCT02944383|144669970|SUPERIORITY|||||||0.7615||||||Ranked ANCOVA results are obtained using a model where the outcome is ranked, randomized treatment group and randomized baseline statin (yes or no) are included as factors, and outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 2||||0.7615
72569551|NCT02944383|144669970|SUPERIORITY|||||||0.0162||||||Ranked ANCOVA results are obtained using a model where the outcome is ranked, randomized treatment group and randomized baseline statin (yes or no) are included as factors, and outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 6||||0.0162
72569552|NCT02944383|144669970|SUPERIORITY|||||||0.371||||||Ranked ANCOVA results are obtained using a model where the outcome is ranked, randomized treatment group and randomized baseline statin (yes or no) are included as factors, and outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 6||||0.3710
72518326|NCT01617187|144566557|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.0|STANDARD_ERROR_OF_MEAN|0.09||0.9598|TWO_SIDED|95.0|-0.2|0.2||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 7||0.2|-0.2|0.9598
72518327|NCT01617187|144566557|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.0|STANDARD_ERROR_OF_MEAN|0.12||0.9789|TWO_SIDED|95.0|-0.2|0.2||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 7||0.2|-0.2|0.9789
72518328|NCT01617187|144566557|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.1|STANDARD_ERROR_OF_MEAN|0.11||0.4671|TWO_SIDED|95.0|-0.3|0.1||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 14||0.1|-0.3|0.4671
72518329|NCT01617187|144566557|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.1|STANDARD_ERROR_OF_MEAN|0.11||0.6359|TWO_SIDED|95.0|-0.3|0.2||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 14||0.2|-0.3|0.6359
72518330|NCT01617187|144566557|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.1|STANDARD_ERROR_OF_MEAN|0.14||0.5454|TWO_SIDED|95.0|-0.4|0.2||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 14||0.2|-0.4|0.5454
72518331|NCT01617187|144566557|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.1|STANDARD_ERROR_OF_MEAN|0.13||0.4188|TWO_SIDED|95.0|-0.2|0.4||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 21||0.4|-0.2|0.4188
72518332|NCT01617187|144566557|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.1|STANDARD_ERROR_OF_MEAN|0.13||0.5318|TWO_SIDED|95.0|-0.3|0.2||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 21||0.2|-0.3|0.5318
72518333|NCT01617187|144566557|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.1|STANDARD_ERROR_OF_MEAN|0.16||0.5683|TWO_SIDED|95.0|-0.4|0.2||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 21||0.2|-0.4|0.5683
72518334|NCT01617187|144566557|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.2|STANDARD_ERROR_OF_MEAN|0.14||0.2972|TWO_SIDED|95.0|-0.1|0.4||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 28||0.4|-0.1|0.2972
72518335|NCT01617187|144566557|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.1|STANDARD_ERROR_OF_MEAN|0.13||0.482|TWO_SIDED|95.0|-0.4|0.2||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 28||0.2|-0.4|0.4820
72518336|NCT01617187|144566557|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.0|STANDARD_ERROR_OF_MEAN|0.17||0.9901|TWO_SIDED|95.0|-0.3|0.3||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 28||0.3|-0.3|0.9901
72518337|NCT01617187|144566557|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.1|STANDARD_ERROR_OF_MEAN|0.15||0.6682|TWO_SIDED|95.0|-0.4|0.2||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 35||0.2|-0.4|0.6682
72518338|NCT01617187|144566557|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.2|STANDARD_ERROR_OF_MEAN|0.14||0.1111|TWO_SIDED|95.0|-0.5|0.1||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 35||0.1|-0.5|0.1111
72518339|NCT01617187|144566557|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.2|STANDARD_ERROR_OF_MEAN|0.17||0.24|TWO_SIDED|95.0|-0.5|0.1||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 35||0.1|-0.5|0.2400
72518340|NCT01617187|144566558|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6205||||||P-value from Cochran Mantel-Haenszel test with an adjustment for pooled center|Cochran-Mantel-Haenszel|||Day 4||||0.6205
72624853|NCT01139515|144779129|SUPERIORITY_OR_OTHER_LEGACY||Adjusted ratio of geometric means|98.57|||||TWO_SIDED|90.0|83.23|116.73||||||"Natural log transformed, dose-normalized Cmax of eletriptan was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.~The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios."||116.73|83.23|
72569553|NCT02944383|144669970|SUPERIORITY|||||||0.001||||||Ranked ANCOVA results are obtained using a model where the outcome is ranked, randomized treatment group and randomized baseline statin (yes or no) are included as factors, and outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.0010
72518341|NCT01617187|144566558|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4829||||||P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center|Cochran-Mantel-Haenszel|||Day 4||||0.4829
72518342|NCT01617187|144566558|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3945||||||P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center|Cochran-Mantel-Haenszel|||Day 4||||0.3945
72518343|NCT01617187|144566558|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4076||||||P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center|Cochran-Mantel-Haenszel|||Day 7||||0.4076
72518344|NCT01617187|144566558|SUPERIORITY_OR_OTHER_LEGACY|||||||0.969||||||P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center|Cochran-Mantel-Haenszel|||Day 7||||0.9690
72518345|NCT01617187|144566558|SUPERIORITY_OR_OTHER_LEGACY|||||||0.117||||||P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center|Cochran-Mantel-Haenszel|||Day 7||||0.1170
72518346|NCT01617187|144566558|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5088||||||P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center|Cochran-Mantel-Haenszel|||Day 14||||0.5088
72518347|NCT01617187|144566558|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3426||||||P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center|Cochran-Mantel-Haenszel|||Day 14||||0.3426
72518348|NCT01617187|144566558|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0762||||||P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center|Cochran-Mantel-Haenszel|||Day 14||||0.0762
72518349|NCT01617187|144566558|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5531||||||P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center|Cochran-Mantel-Haenszel|||Day 21||||0.5531
72518350|NCT01617187|144566558|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4875||||||P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center|Cochran-Mantel-Haenszel|||Day 21||||0.4875
72518351|NCT01617187|144566558|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0692||||||P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center|Cochran-Mantel-Haenszel|||Day 21||||0.0692
72518352|NCT01617187|144566558|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7482||||||P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center|Cochran-Mantel-Haenszel|||Day 28||||0.7482
72518353|NCT01617187|144566558|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8037||||||P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center|Cochran-Mantel-Haenszel|||Day 28||||0.8037
72518354|NCT01617187|144566558|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0859||||||P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center|Cochran-Mantel-Haenszel|||Day 28||||0.0859
72518355|NCT01617187|144566558|SUPERIORITY_OR_OTHER_LEGACY|||||||0.585||||||P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center|Cochran-Mantel-Haenszel|||Day 35||||0.5850
72518356|NCT01617187|144566558|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9698||||||P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center|Cochran-Mantel-Haenszel|||Day 35||||0.9698
72569554|NCT02944383|144669970|SUPERIORITY|||||||0.0988||||||Ranked ANCOVA results are obtained using a model where the outcome is ranked, randomized treatment group and randomized baseline statin (yes or no) are included as factors, and outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.0988
72518357|NCT01617187|144566558|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0132||||||P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center|Cochran-Mantel-Haenszel|||Day 35||||0.0132
72518358|NCT01617187|144566558|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7129||||||P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center|Cochran-Mantel-Haenszel|||Day 42||||0.7129
72518359|NCT01617187|144566558|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5074||||||P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center|Cochran-Mantel-Haenszel|||Day 42||||0.5074
72518360|NCT01617187|144566558|SUPERIORITY_OR_OTHER_LEGACY|||||||0.004||||||P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center|Cochran-Mantel-Haenszel|||Day 42||||0.0040
72518361|NCT01617187|144566559|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.1|STANDARD_ERROR_OF_MEAN|0.4||0.8829|TWO_SIDED|95.0|-0.7|0.8||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 4||0.8|-0.7|0.8829
72518362|NCT01617187|144566559|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.2|STANDARD_ERROR_OF_MEAN|0.39||0.5488|TWO_SIDED|95.0|-0.5|1.0||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 4||1.0|-0.5|0.5488
72518363|NCT01617187|144566559|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.1|STANDARD_ERROR_OF_MEAN|0.5||0.783|TWO_SIDED|95.0|-1.1|0.8||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 4||0.8|-1.1|0.7830
72518364|NCT01617187|144566559|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.1|STANDARD_ERROR_OF_MEAN|0.45||0.807|TWO_SIDED|95.0|-1.0|0.8||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 7||0.8|-1.0|0.8070
72518365|NCT01617187|144566559|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.3|STANDARD_ERROR_OF_MEAN|0.44||0.528|TWO_SIDED|95.0|-1.1|0.6||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 7||0.6|-1.1|0.5280
72518366|NCT01617187|144566559|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.5|STANDARD_ERROR_OF_MEAN|0.57||0.4025|TWO_SIDED|95.0|-1.6|0.6||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 7||0.6|-1.6|0.4025
72518367|NCT01617187|144566559|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.2|STANDARD_ERROR_OF_MEAN|0.51||0.6471|TWO_SIDED|95.0|-0.8|1.2||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 14||1.2|-0.8|0.6471
72518368|NCT01617187|144566559|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.6|STANDARD_ERROR_OF_MEAN|0.49||0.2504|TWO_SIDED|95.0|-1.5|0.4||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 14||0.4|-1.5|0.2504
72518369|NCT01617187|144566559|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.1|STANDARD_ERROR_OF_MEAN|0.62||0.9223|TWO_SIDED|95.0|-1.2|1.3||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 14||1.3|-1.2|0.9223
72518370|NCT01617187|144566559|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.1|STANDARD_ERROR_OF_MEAN|0.56||0.8839|TWO_SIDED|95.0|-1.0|1.2||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 21||1.2|-1.0|0.8839
72518371|NCT01617187|144566559|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.1|STANDARD_ERROR_OF_MEAN|0.54||0.8077|TWO_SIDED|95.0|-1.2|0.9||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 21||0.9|-1.2|0.8077
72518372|NCT01617187|144566559|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.3|STANDARD_ERROR_OF_MEAN|0.68||0.6216|TWO_SIDED|95.0|-1.0|1.7||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 21||1.7|-1.0|0.6216
72518373|NCT01617187|144566559|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.5|STANDARD_ERROR_OF_MEAN|0.61||0.4248|TWO_SIDED|95.0|-0.7|1.7||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 28||1.7|-0.7|0.4248
72518374|NCT01617187|144566559|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.2|STANDARD_ERROR_OF_MEAN|0.58||0.7667|TWO_SIDED|95.0|-1.3|1.0||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 28||1.0|-1.3|0.7667
72569555|NCT02944383|144669970|SUPERIORITY|||||||0.2594||||||Ranked ANCOVA results are obtained using a model where the outcome is ranked, randomized treatment group and randomized baseline statin (yes or no) are included as factors, and outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.2594
72518375|NCT01617187|144566559|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.4|STANDARD_ERROR_OF_MEAN|0.72||0.6282|TWO_SIDED|95.0|-1.1|1.8||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 28||1.8|-1.1|0.6282
72518376|NCT01617187|144566559|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.7|STANDARD_ERROR_OF_MEAN|0.65||0.315|TWO_SIDED|95.0|-1.9|0.6||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 35||0.6|-1.9|0.3150
72518377|NCT01617187|144566559|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.8|STANDARD_ERROR_OF_MEAN|0.61||0.1908|TWO_SIDED|95.0|-2.0|0.4||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 35||0.4|-2.0|0.1908
72518378|NCT01617187|144566559|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.8|STANDARD_ERROR_OF_MEAN|0.77||0.3128|TWO_SIDED|95.0|-2.3|0.7||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 35||0.7|-2.3|0.3128
72518379|NCT01617187|144566559|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.1|STANDARD_ERROR_OF_MEAN|0.73||0.8812|TWO_SIDED|95.0|-1.5|1.3||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 42||1.3|-1.5|0.8812
72624854|NCT01139515|144779129|SUPERIORITY_OR_OTHER_LEGACY||Adjusted ratio of geometric means|107.44|||||TWO_SIDED|90.0|90.72|127.25||||||"Natural log transformed, dose-normalized Cmax of eletriptan was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.~The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios."||127.25|90.72|
72518380|NCT01617187|144566559|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-1.1|STANDARD_ERROR_OF_MEAN|0.69||0.1143|TWO_SIDED|95.0|-2.4|0.3||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 42||0.3|-2.4|0.1143
72518381|NCT01617187|144566559|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.6|STANDARD_ERROR_OF_MEAN|0.84||0.4418|TWO_SIDED|95.0|-2.3|1.0||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 42||1.0|-2.3|0.4418
72518382|NCT01617187|144566560|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.5|STANDARD_ERROR_OF_MEAN|0.4||0.216|TWO_SIDED|95.0|-0.3|1.3||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 4||1.3|-0.3|0.2160
72518383|NCT01617187|144566560|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.0|STANDARD_ERROR_OF_MEAN|0.39||0.9494|TWO_SIDED|95.0|-0.7|0.8||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 4||0.8|-0.7|0.9494
72518384|NCT01617187|144566560|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.7|STANDARD_ERROR_OF_MEAN|0.5||0.1834|TWO_SIDED|95.0|-1.6|0.3||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 4||0.3|-1.6|0.1834
72518385|NCT01617187|144566560|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.3|STANDARD_ERROR_OF_MEAN|0.53||0.6347|TWO_SIDED|95.0|-0.8|1.3||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 7||1.3|-0.8|0.6347
72518386|NCT01617187|144566560|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.2|STANDARD_ERROR_OF_MEAN|0.51||0.6917|TWO_SIDED|95.0|-1.2|0.8||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 7||0.8|-1.2|0.6917
72518387|NCT01617187|144566560|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-1.0|STANDARD_ERROR_OF_MEAN|0.66||0.1431|TWO_SIDED|95.0|-2.3|0.3||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 7||0.3|-2.3|0.1431
72518388|NCT01617187|144566560|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.3|STANDARD_ERROR_OF_MEAN|0.61||0.6267|TWO_SIDED|95.0|-0.9|1.5||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 14||1.5|-0.9|0.6267
72518389|NCT01617187|144566560|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.2|STANDARD_ERROR_OF_MEAN|0.58||0.726|TWO_SIDED|95.0|-1.3|0.9||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 14||0.9|-1.3|0.7260
72518390|NCT01617187|144566560|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.7|STANDARD_ERROR_OF_MEAN|0.74||0.3326|TWO_SIDED|95.0|-2.2|0.7||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 14||0.7|-2.2|0.3326
72518391|NCT01617187|144566560|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.5|STANDARD_ERROR_OF_MEAN|0.72||0.4575|TWO_SIDED|95.0|-0.9|1.9||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 21||1.9|-0.9|0.4575
72518392|NCT01617187|144566560|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.5|STANDARD_ERROR_OF_MEAN|0.68||0.493|TWO_SIDED|95.0|-1.8|0.9||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 21||0.9|-1.8|0.4930
72518393|NCT01617187|144566560|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-1.1|STANDARD_ERROR_OF_MEAN|0.86||0.1886|TWO_SIDED|95.0|-2.8|0.6||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 21||0.6|-2.8|0.1886
72518394|NCT01617187|144566560|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.9|STANDARD_ERROR_OF_MEAN|0.8||0.2643|TWO_SIDED|95.0|-0.7|2.5||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 28||2.5|-0.7|0.2643
72518395|NCT01617187|144566560|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.7|STANDARD_ERROR_OF_MEAN|0.76||0.3516|TWO_SIDED|95.0|-2.2|0.8||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 28||0.8|-2.2|0.3516
72518396|NCT01617187|144566560|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-1.2|STANDARD_ERROR_OF_MEAN|0.94||0.2068|TWO_SIDED|95.0|-3.1|0.7||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 28||0.7|-3.1|0.2068
72518397|NCT01617187|144566560|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.3|STANDARD_ERROR_OF_MEAN|0.82||0.7284|TWO_SIDED|95.0|-1.3|1.9||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 35||1.9|-1.3|0.7284
72518398|NCT01617187|144566560|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.9|STANDARD_ERROR_OF_MEAN|0.77||0.2698|TWO_SIDED|95.0|-2.4|0.7||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 35||0.7|-2.4|0.2698
72518399|NCT01617187|144566560|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-1.4|STANDARD_ERROR_OF_MEAN|0.96||0.151|TWO_SIDED|95.0|-3.3|0.5||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 35||0.5|-3.3|0.1510
72518400|NCT01617187|144566560|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.2|STANDARD_ERROR_OF_MEAN|0.88||0.8039|TWO_SIDED|95.0|-2.0|1.5||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 42||1.5|-2.0|0.8039
72518401|NCT01617187|144566560|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-1.8|STANDARD_ERROR_OF_MEAN|0.83||0.0306|TWO_SIDED|95.0|-3.5|-0.2||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 42||-0.2|-3.5|0.0306
72518402|NCT01617187|144566560|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-2.1|STANDARD_ERROR_OF_MEAN|1.03||0.0406|TWO_SIDED|95.0|-4.1|-0.1||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 42||-0.1|-4.1|0.0406
72518403|NCT01617187|144566561|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.2|STANDARD_ERROR_OF_MEAN|0.66||0.7819|TWO_SIDED|95.0|-1.1|1.5||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 4||1.5|-1.1|0.7819
72518404|NCT01617187|144566561|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.2|STANDARD_ERROR_OF_MEAN|0.65||0.703|TWO_SIDED|95.0|-1.5|1.0||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 4||1.0|-1.5|0.7030
72518405|NCT01617187|144566561|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.1|STANDARD_ERROR_OF_MEAN|0.83||0.952|TWO_SIDED|95.0|-1.7|1.6||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 4||1.6|-1.7|0.9520
72518406|NCT01617187|144566561|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.3|STANDARD_ERROR_OF_MEAN|0.95||0.7907|TWO_SIDED|95.0|-2.1|1.6||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 7||1.6|-2.1|0.7907
72405407|NCT01479621|144318824|SUPERIORITY_OR_OTHER||LSM difference|0.052||||0.2227|TWO_SIDED|95.0|-0.032|0.136|||mixed model for repeated measures|||This is the fifth analysis in the fixed-sequence testing procedure employed to control the overall Type I error rate at the 0.05 level.||0.136|-0.032|0.2227
72405408|NCT01479621|144318825|SUPERIORITY_OR_OTHER|||||||0.0017||||||Significance at 0.05|Regression, Linear|||A linear in log-dose trend contrast evaluated the time-averaged dose-response trend, where the logarithm of dose was defined as log(dose+1) to accommodate the case of a zero dose (placebo).||||0.0017
72405409|NCT01479621|144318825|SUPERIORITY_OR_OTHER||LSM difference|18.29||||0.006|TWO_SIDED|95.0|5.28|31.29||Significance at 0.05|mixed model for repeated measures|||||31.29|5.28|0.0060
72405410|NCT01479621|144318825|SUPERIORITY_OR_OTHER||LSM difference|20.32||||0.0018|TWO_SIDED|95.0|7.61|33.03||Significance at 0.05|mixed model for repeated measures|||||33.03|7.61|0.0018
72405411|NCT01479621|144318825|SUPERIORITY_OR_OTHER||LSM difference|11.75||||0.0741|TWO_SIDED|95.0|-1.15|24.64||Significance at 0.05|mixed model for repeated measures|||||24.64|-1.15|0.0741
72405412|NCT01479621|144318825|SUPERIORITY_OR_OTHER||LSM difference|21.72||||0.0011|TWO_SIDED|95.0|8.73|34.72||Significance at 0.05|mixed model for repeated measures|||||34.72|8.73|0.0011
72405413|NCT01479621|144318826|SUPERIORITY_OR_OTHER|||||||0.0434||||||Significance at 0.05|Regression, Linear|||A linear in log-dose trend contrast evaluated the time-averaged dose-response trend, where the logarithm of dose was defined as log(dose+1) to accommodate the case of a zero dose (placebo).||||0.0434
72405414|NCT01479621|144318826|SUPERIORITY_OR_OTHER||LSM difference|11.06||||0.0852|TWO_SIDED|95.0|-1.54|23.66||Significance at 0.05|mixed model for repeated measures|||||23.66|-1.54|0.0852
72405415|NCT01479621|144318826|SUPERIORITY_OR_OTHER||LSM difference|12.78||||0.0411|TWO_SIDED|95.0|0.52|25.04||Significance at 0.05|mixed model for repeated measures|||||25.04|0.52|0.0411
72405416|NCT01479621|144318826|SUPERIORITY_OR_OTHER||LSM difference|9.28||||0.1428|TWO_SIDED|95.0|-3.14|21.69||Significance at 0.05|mixed model for repeated measures|||||21.69|-3.14|0.1428
72405417|NCT01479621|144318826|SUPERIORITY_OR_OTHER||LSM difference|18.23||||0.0046|TWO_SIDED|95.0|5.64|30.82||Significance at 0.05|mixed model for repeated measures|||||30.82|5.64|0.0046
72405418|NCT01479621|144318827|SUPERIORITY_OR_OTHER||estimated mean difference from placebo|2.76||||0.66685|TWO_SIDED|95.0|-10.07|15.6|||GEE|The model contained covariates for sex, age, and treatment. The baseline level was estimated for all subjects combined, adjusted for covariates.||The generalized estimating equation (GEE) algorithm was used to fit the model, using a robust estimator for the variance which provided a proper adjustment for possible correlation between the 2 measurements on each subject. This model was used to obtain 2-sided 95% confidence limits for the difference in treatment effects of Fp MDPI versus placebo.||15.60|-10.07|0.66685
72405419|NCT01479621|144318827|SUPERIORITY_OR_OTHER||estimated mean difference from placebo|6.76||||0.26741|TWO_SIDED|95.0|-5.43|18.94||The model contained covariates for sex, age, and treatment. The baseline level was estimated for all subjects combined, adjusted for covariates.|GEE|||The generalized estimating equation (GEE) algorithm was used to fit the model, using a robust estimator for the variance which provided a proper adjustment for possible correlation between the 2 measurements on each subject. This model was used to obtain 2-sided 95% confidence limits for the difference in treatment effects of Fp MDPI versus placebo.||18.94|-5.43|0.26741
72405420|NCT01479621|144318827|SUPERIORITY_OR_OTHER||estimated mean difference from placebo|10.45||||0.09964|TWO_SIDED|95.0|-2.24|23.15||The model contained covariates for sex, age, and treatment. The baseline level was estimated for all subjects combined, adjusted for covariates.|GEE|||The generalized estimating equation (GEE) algorithm was used to fit the model, using a robust estimator for the variance which provided a proper adjustment for possible correlation between the 2 measurements on each subject. This model was used to obtain 2-sided 95% confidence limits for the difference in treatment effects of Fp MDPI versus placebo.||23.15|-2.24|0.09964
72492937|NCT01687712|144514574|SUPERIORITY|Comparisons were tested against a null of zero at the two-side 5% significance level.||||||0.612||||||P-values are based upon Type III sums of squares.|ANCOVA|Treatment group and Site are included as factors.||"The null and alternative hypotheses are as follows:~H0: p2- p1 = 0 and H1: p2- p1 ≠0,~where p1 is the least squares adjusted mean number of oocytes retrieved in the AFOLIA treatment group and p2 is the least squares adjusted mean number of oocytes retrieved in the Gonal f® treatment group."||||0.612
72492938|NCT00371865|144514584|SUPERIORITY_OR_OTHER|||||||0.27|TWO_SIDED||||||Mixed Models Analysis|||||||.27
72492939|NCT00371865|144514585|SUPERIORITY_OR_OTHER|||||||0.9|TWO_SIDED||||||Mixed Models Analysis|||||||.90
72492940|NCT00371865|144514586|SUPERIORITY_OR_OTHER|||||||0.13|TWO_SIDED||||||Mixed Models Analysis|||||||.13
72492941|NCT00371865|144514587|SUPERIORITY_OR_OTHER|||||||0.26|TWO_SIDED||||||Mixed Models Analysis|||||||.26
72492942|NCT00371865|144514588|SUPERIORITY_OR_OTHER|||||||0.9|TWO_SIDED||||||Mixed Models Analysis|||||||.90
72492943|NCT01328951|144514600|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.02||||0.8183|TWO_SIDED|95.0|0.85|1.22|||Log Rank||The HR and 95% confidence interval (CI) were estimated by Cox regression.|Unstratified Analysis.||1.22|0.85|0.8183
72492944|NCT01328951|144514600|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.07||||0.5256|TWO_SIDED|95.0|0.87|1.32|||Log Rank||The HR and 95% CI were estimated by Cox regression.|Stratified Analysis: Stratified according to tumor histology, stage of disease, objective response at Baseline, bevacizumab use, smoking status, and region of enrollment.||1.32|0.87|0.5256
72492945|NCT01328951|144514601|SUPERIORITY_OR_OTHER||Difference in Event-Free Rate|-0.4||||0.9207|TWO_SIDED|95.0|-8.25|7.45|||Chi-squared|||||7.45|-8.25|0.9207
72492946|NCT01328951|144514603|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.94||||0.4759|TWO_SIDED|95.0|0.8|1.11|||Log Rank||The HR and 95% CI were estimated by Cox regression.|Unstratified Analysis.||1.11|0.80|0.4759
72492947|NCT01328951|144514603|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.87||||0.1635|TWO_SIDED|95.0|0.72|1.06|||Log Rank||The HR and 95% CI were estimated by Cox regression.|Stratified Analysis: Stratified according to tumor histology, stage of disease, objective response at Baseline, bevacizumab use, smoking status, and region of enrollment.||1.06|0.72|0.1635
72492948|NCT01328951|144514604|SUPERIORITY_OR_OTHER||Difference in Event-Free Rate|-2.89||||0.4069|TWO_SIDED|95.0|-9.7|3.93|||Chi-squared|||||3.93|-9.70|0.4069
72405421|NCT01479621|144318827|SUPERIORITY_OR_OTHER||Slope|12.78||||0.03825|TWO_SIDED|95.0|0.44|25.11||The model contained covariates for sex, age, and treatment. The baseline level was estimated for all subjects combined, adjusted for covariates.|GEE|||The generalized estimating equation (GEE) algorithm was used to fit the model, using a robust estimator for the variance which provided a proper adjustment for possible correlation between the 2 measurements on each subject. This model was used to obtain 2-sided 95% confidence limits for the difference in treatment effects of Fp MDPI versus placebo.||25.11|0.44|0.03825
72405422|NCT01479621|144318828|SUPERIORITY_OR_OTHER|||||||0.2841||||||Significance at 0.05|Log Rank|||Comparison of survival curve to placebo||||0.2841
72405423|NCT01479621|144318828|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Significance at 0.05|Log Rank|||Comparison of survival curve to placebo||||<0.0001
72405424|NCT01479621|144318828|SUPERIORITY_OR_OTHER|||||||0.0008||||||Significance at 0.05|Log Rank|||Comparison of survival curve to placebo||||0.0008
72405425|NCT01479621|144318828|SUPERIORITY_OR_OTHER|||||||0.001||||||Significance at 0.05|Log Rank|||Comparison of survival curve to placebo||||0.0010
72518407|NCT01617187|144566561|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-1.4|STANDARD_ERROR_OF_MEAN|0.91||0.1391|TWO_SIDED|95.0|-3.1|0.4||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 7||0.4|-3.1|0.1391
72518408|NCT01617187|144566561|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.8|STANDARD_ERROR_OF_MEAN|1.18||0.4901|TWO_SIDED|95.0|-3.1|1.5||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 7||1.5|-3.1|0.4901
72518409|NCT01617187|144566561|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.2|STANDARD_ERROR_OF_MEAN|1.0||0.8079|TWO_SIDED|95.0|-1.7|2.2||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 14||2.2|-1.7|0.8079
72518410|NCT01617187|144566561|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.8|STANDARD_ERROR_OF_MEAN|0.95||0.3889|TWO_SIDED|95.0|-2.7|1.1||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 14||1.1|-2.7|0.3889
72405426|NCT01479621|144318834|SUPERIORITY_OR_OTHER||LSM difference|-0.114||||0.0058|TWO_SIDED|95.0|-0.195|-0.033||Significance at 0.05|mixed model for repeated measures|||||-0.033|-0.195|0.0058
72405427|NCT01479621|144318834|SUPERIORITY_OR_OTHER||LSM difference|0.034||||0.4083|TWO_SIDED|95.0|-0.046|0.114||Significance at 0.05|mixed model for repeated measures|||||0.114|-0.046|0.4083
72405428|NCT01479621|144318834|SUPERIORITY_OR_OTHER||LSM difference|0.011||||0.7882|TWO_SIDED|95.0|-0.068|0.089||Significance at 0.05|mixed model for repeated measures|||||0.089|-0.068|0.7882
72405429|NCT01479621|144318834|SUPERIORITY_OR_OTHER||LSM difference|-0.002||||0.9586|TWO_SIDED|95.0|-0.082|0.078||Significance at 0.05|mixed model for repeated measures|||||0.078|-0.082|0.9586
72518411|NCT01617187|144566561|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-1.0|STANDARD_ERROR_OF_MEAN|1.21||0.3907|TWO_SIDED|95.0|-3.4|1.3||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 14||1.3|-3.4|0.3907
72518412|NCT01617187|144566561|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.7|STANDARD_ERROR_OF_MEAN|1.15||0.5363|TWO_SIDED|95.0|-1.5|3.0||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 21||3.0|-1.5|0.5363
72518413|NCT01617187|144566561|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.7|STANDARD_ERROR_OF_MEAN|1.09||0.5075|TWO_SIDED|95.0|-2.9|1.4||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 21||1.4|-2.9|0.5075
72518414|NCT01617187|144566561|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-1.0|STANDARD_ERROR_OF_MEAN|1.38||0.4526|TWO_SIDED|95.0|-3.7|1.7||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 21||1.7|-3.7|0.4526
72405430|NCT01479621|144318834|SUPERIORITY_OR_OTHER||LSM difference|-0.062||||0.1306|TWO_SIDED|95.0|-0.143|0.018||Significance at 0.05|mixed model for repeated measures|||||0.018|-0.143|0.1306
72405431|NCT01479621|144318835|SUPERIORITY_OR_OTHER||LSM difference|-17.66||||0.0068|TWO_SIDED|95.0|-30.43|-4.89||Significance at 0.05|mixed model for repeated measures|||||-4.89|-30.43|0.0068
72405432|NCT01479621|144318835|SUPERIORITY_OR_OTHER||LSM difference|0.69||||0.9135|TWO_SIDED|95.0|-11.84|13.23||Significance at 0.05|mixed model for repeated measures|||||13.23|-11.84|0.9135
72405433|NCT01479621|144318835|SUPERIORITY_OR_OTHER||LSM difference|2.67||||0.6689|TWO_SIDED|95.0|-9.58|14.92||Significance at 0.05|mixed model for repeated measures|||||14.92|-9.58|0.6689
72405434|NCT01479621|144318835|SUPERIORITY_OR_OTHER||LSM difference|-5.69||||0.3691|TWO_SIDED|95.0|-18.12|6.74||Significance at 0.05|mixed model for repeated measures|||||6.74|-18.12|0.3691
72405435|NCT01479621|144318835|SUPERIORITY_OR_OTHER||LSM difference|4.24||||0.5072|TWO_SIDED|95.0|-8.31|16.78||Significance at 0.05|mixed model for repeated measures|||||16.78|-8.31|0.5072
72405436|NCT01479621|144318836|SUPERIORITY_OR_OTHER||LSM difference|-15.26||||0.0158|TWO_SIDED|95.0|-27.63|-2.88||Significance at 0.05|mixed model for repeated measures|||||-2.88|-27.63|0.0158
72405437|NCT01479621|144318836|SUPERIORITY_OR_OTHER||LSM difference|-4.48||||0.4709|TWO_SIDED|95.0|-16.69|7.721||Significance at 0.05|mixed model for repeated measures|||||7.721|-16.69|0.4709
72405438|NCT01479621|144318836|SUPERIORITY_OR_OTHER||LSM difference|-2.68||||0.6572|TWO_SIDED|95.0|-14.55|9.19||Significance at 0.05|mixed model for repeated measures|||||9.19|-14.55|0.6572
72405439|NCT01479621|144318836|SUPERIORITY_OR_OTHER||LSM difference|-5.98||||0.3292|TWO_SIDED|95.0|-18.01|6.05||Significance at 0.05|mixed model for repeated measures|||||6.05|-18.01|0.3292
72405440|NCT01479621|144318836|SUPERIORITY_OR_OTHER||LSM difference|3.05||||0.6237|TWO_SIDED|95.0|-9.16|15.26||Significance at 0.05|mixed model for repeated measures|||||15.26|-9.16|0.6237
72405441|NCT05422053|144318847|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||End of Control-IQ Use (13 Weeks) compared to Control-IQ Start||||<0.001
72405442|NCT02439775|144318870|SUPERIORITY|||||||0.1194||||||p\<0.05 required for significance|ANCOVA|||||||0.1194
72405443|NCT00915798|144318886|SUPERIORITY_OR_OTHER||F|0.56||||0.46|TWO_SIDED||||||ANOVA|Threshold for statistical significance p \< 0.05||Frontal BOLD during abstinence in smokers and nonsmokers||||0.46
72405444|NCT00915798|144318886|SUPERIORITY_OR_OTHER||F|6.64||||0.012|TWO_SIDED||||||ANOVA|Threshold for statistical significance p \< 0.05|Diagnosis by smoking status interaction.|Parietal BOLD during abstinence in smokers and nonsmokers||||0.012
72405445|NCT00915798|144318886|SUPERIORITY_OR_OTHER||F|211.2||||0.04|TWO_SIDED||||||ANOVA|Threshold for statistical significance p \< 0.05|Main effect for smoking status.|Occipital BOLD during abstinence in smokers and nonsmokers.||||0.04
72405446|NCT00915798|144318886|SUPERIORITY_OR_OTHER||F|1.6||||0.22|TWO_SIDED||||||ANOVA|Threshold for statistical significance p \< 0.05||Frontal BOLD smoking versus nonsmoking in smokers with ADHD compared to control smokers.||||0.22
72405447|NCT00915798|144318886|SUPERIORITY_OR_OTHER||F|0.43||||0.51|TWO_SIDED||||||ANOVA|Threshold for statistical significance p \< 0.05||Parietal BOLD smoking versus nonsmoking in smokers with ADHD compared to control smokers.||||0.51
72569556|NCT02944383|144669970|SUPERIORITY|||||||0.9099||||||Ranked ANCOVA results are obtained using a model where the outcome is ranked, randomized treatment group and randomized baseline statin (yes or no) are included as factors, and outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.9099
72569557|NCT02944383|144669970|SUPERIORITY|||||||0.0219||||||Ranked ANCOVA results are obtained using a model where the outcome is ranked, randomized treatment group and randomized baseline statin (yes or no) are included as factors, and outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||EOS (average of week 10 and 12)||||0.0219
72569558|NCT02944383|144669970|SUPERIORITY|||||||0.3494||||||Ranked ANCOVA results are obtained using a model where the outcome is ranked, randomized treatment group and randomized baseline statin (yes or no) are included as factors, and outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||EOS (average of week 10 and 12)||||0.3494
72569559|NCT02944383|144669971|SUPERIORITY|||||||0.0391||||||Results are obtained using a model where outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 2||||0.0391
72569560|NCT02944383|144669971|SUPERIORITY|||||||0.2455||||||Results are obtained using a model where outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 2||||0.2455
72569561|NCT02944383|144669971|SUPERIORITY|||||||0.026||||||Results are obtained using a model where outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 6||||0.0260
72569562|NCT02944383|144669971|SUPERIORITY|||||||0.5704||||||Results are obtained using a model where outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 6||||0.5704
72518415|NCT01617187|144566561|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|1.8|STANDARD_ERROR_OF_MEAN|1.26||0.1548|TWO_SIDED|95.0|-0.7|4.3||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 28||4.3|-0.7|0.1548
72518416|NCT01617187|144566561|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.5|STANDARD_ERROR_OF_MEAN|1.19||0.6589|TWO_SIDED|95.0|-2.9|1.8||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 28||1.8|-2.9|0.6589
72518417|NCT01617187|144566561|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-1.0|STANDARD_ERROR_OF_MEAN|1.48||0.5171|TWO_SIDED|95.0|-3.9|2.0||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 28||2.0|-3.9|0.5171
72518418|NCT01617187|144566561|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-1.2|STANDARD_ERROR_OF_MEAN|1.2||0.3133|TWO_SIDED|95.0|-3.6|1.2||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 35||1.2|-3.6|0.3133
72518419|NCT01617187|144566561|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-1.6|STANDARD_ERROR_OF_MEAN|1.13||0.1723|TWO_SIDED|95.0|-3.8|0.7||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 35||0.7|-3.8|0.1723
72569563|NCT02944383|144669971|SUPERIORITY|||||||0.0009||||||Results are obtained using a model where outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.0009
72569564|NCT02944383|144669971|SUPERIORITY|||||||0.0846||||||Results are obtained using a model where outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.0846
72569565|NCT02944383|144669971|SUPERIORITY|||||||0.1763||||||Results are obtained using a model where outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.1763
72569566|NCT02944383|144669971|SUPERIORITY|||||||0.5576||||||Results are obtained using a model where outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.5576
72569567|NCT02944383|144669971|SUPERIORITY||Median Difference (Net)|-14.66||||0.0086|TWO_SIDED|95.0|-24.68|-4.39||Results are obtained using a model where outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|EOS (average of week 10 and 12)||-4.39|-24.68|0.0086
72569568|NCT02944383|144669971|SUPERIORITY||Mean Difference (Net)|-5.06||||0.1516|TWO_SIDED|95.0|-15.02|3.64||Results are obtained using a model where outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|EOS (average of week 10 and 12)||3.64|-15.02|0.1516
72569569|NCT02944383|144669972|SUPERIORITY|||||||0.0386||||||Results are obtained using a model where outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 2||||0.0386
72569570|NCT02944383|144669972|SUPERIORITY|||||||0.1206||||||Results are obtained using a model where outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 2||||0.1206
72405448|NCT00915798|144318886|SUPERIORITY_OR_OTHER||F|0.16||||0.69|TWO_SIDED||||||ANOVA|Threshold for statistical significance p \< 0.05||Occipital BOLD smoking versus nonsmoking in smokers with ADHD compared to control smokers.||||0.69
72405449|NCT02244580|144318891|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.423||||0.0018|TWO_SIDED|95.0|0.246|0.726|||Regression, Cox|||||0.726|0.246|0.0018
72518420|NCT01617187|144566561|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-2.6|STANDARD_ERROR_OF_MEAN|1.42||0.0663|TWO_SIDED|95.0|-5.4|0.2||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 35||0.2|-5.4|0.0663
72569571|NCT02944383|144669972|SUPERIORITY|||||||0.0364||||||Results are obtained using a model where outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 6||||0.0364
72569572|NCT02944383|144669972|SUPERIORITY|||||||0.4312||||||Results are obtained using a model where outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 6||||0.4312
72405450|NCT02244580|144318892|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.42||||0.001|TWO_SIDED|95.0|0.25|0.71|||Regression, Cox|||||0.71|0.25|0.001
72492949|NCT01328951|144514605|SUPERIORITY_OR_OTHER||Difference in Response Rate|2.78||||0.1097|TWO_SIDED|95.0|-0.78|6.35|||Chi-squared||The 95% CI for difference in response rates was constructed using the Anderson-Hauck method.|||6.35|-0.78|0.1097
72492950|NCT01328951|144514605|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.8|||||TWO_SIDED|95.0|0.87|3.72|||||The 95% CI for OR was constructed using the Wald method.|||3.72|0.87|
72492951|NCT01328951|144514607|SUPERIORITY_OR_OTHER||Difference in Response Rate|1.99||||0.6062|TWO_SIDED|95.0|-5.74|9.72|||Chi-squared||The 95% CI for difference in response rates was constructed using the Anderson-Hauck method.|||9.72|-5.74|0.6062
72492952|NCT01328951|144514607|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.09|||||TWO_SIDED|95.0|0.79|1.49|||||The 95% CI for OR was constructed using the Wald method.|||1.49|0.79|
72492953|NCT00970853|144514608|NON_INFERIORITY_OR_EQUIVALENCE|The original sample for this study (N=302) was sufficient for an 80% detection of differences in means of at least 1/2 standard deviation. This analysis presents the results of the follow-up of the original sample.||||||0.39||||||non-adjusted for multiple comparisons|t-test, 2 sided|||||||0.39
72492954|NCT00970853|144514609|NON_INFERIORITY_OR_EQUIVALENCE|In our original sample of 302, we had 80% power to detect significant differences of at least .5 standard deviation between groups.||||||0.99|||||||t-test, 2 sided|||||||.99
72492955|NCT00970853|144514610|NON_INFERIORITY_OR_EQUIVALENCE|In our original sample of 302, we had 80% power to detect significant differences of at least .5 standard deviation between groups.||||||0.16|||||||t-test, 2 sided|||||||0.16
72492956|NCT00970853|144514611|NON_INFERIORITY_OR_EQUIVALENCE|In our original sample of 302, we had 80% power to detect significant differences of at least .5 standard deviation between groups.||||||0.4|||||||t-test, 2 sided|||||||.40
72492957|NCT00970853|144514612|NON_INFERIORITY_OR_EQUIVALENCE|In our original sample of 302, we had 80% power to detect significant differences of at least .5 standard deviation between groups.||||||0.56|||||||t-test, 2 sided|||||||.56
72492958|NCT00970853|144514613|NON_INFERIORITY_OR_EQUIVALENCE|In our original sample of 302, we had 80% power to detect significant differences of at least .5 standard deviation between groups.||||||0.34|||||||t-test, 2 sided|||||||.34
72492959|NCT00970853|144514614|NON_INFERIORITY_OR_EQUIVALENCE|In our original sample of 302, we had 80% power to detect significant differences of at least .5 standard deviation between groups.||||||0.85|||||||t-test, 2 sided|||||||.85
72492960|NCT00970853|144514615|NON_INFERIORITY_OR_EQUIVALENCE|In our original sample of 302, we had 80% power to detect significant differences of at least .5 standard deviation between groups.||||||0.61|||||||t-test, 2 sided|||||||.61
72492961|NCT00970853|144514616|NON_INFERIORITY_OR_EQUIVALENCE|In our original sample of 302, we had 80% power to detect significant differences of at least .5 standard deviation between groups.||||||0.67|||||||t-test, 2 sided|||||||.67
72492962|NCT00271817|144514626|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-38.4|STANDARD_ERROR_OF_MEAN|1.5|<|0.001||95.0|-41.4|-35.4||A fixed sequence testing procedure was employed where testing followed a prespecified order and each subsequent hypothesis was tested at the 0.05 level of significance only if all previously tested hypotheses have been rejected.|ANCOVA|ANCOVA with terms for treatment, baseline LDL-C, baseline TG, and gender.|Mean difference = Ezetimibe/Simvastatin + Niacin minus Niacin|||-35.4|-41.4|<0.001
72492963|NCT00271817|144514627|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-33.5|STANDARD_ERROR_OF_MEAN|1.5|<|0.001||95.0|-36.5|-30.6||A fixed sequence testing procedure was employed where testing followed a prespecified order and each subsequent hypothesis was tested at the 0.05 level of significance only if all previously tested hypotheses have been rejected.|ANCOVA|ANCOVA with terms for treatment, baseline LDL-C, baseline TG, and gender.|Mean difference = Ezetimibe/Simvastatin + Niacin minus Niacin|||-30.6|-36.5|<0.001
72492964|NCT00271817|144514628|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|22.1|STANDARD_ERROR_OF_MEAN|1.6|<|0.001||95.0|18.8|25.3||A fixed sequence testing procedure was employed where testing followed a prespecified order and each subsequent hypothesis was tested at the 0.05 level of significance only if all previously tested hypotheses have been rejected.|ANCOVA|ANCOVA with terms for treatment, baseline LDL-C, baseline TG, and gender.|Mean difference = Ezetimibe/Simvastatin + Niacin minus Niacin|||25.3|18.8|<0.001
72492965|NCT00271817|144514629|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-18.7|||<|0.001||95.0|-22.6|-14.7||A fixed sequence testing procedure was employed where testing followed a prespecified order and each subsequent hypothesis was tested at the 0.05 level of significance only if all previously tested hypotheses have been rejected.|ANCOVA|ANCOVA using ranks based on normal scores (Tukey method) with model terms for treatment, baseline LDL-C, baseline TG and gender|"Mean difference = Ezetimibe/Simvastatin + Niacin minus Niacin~The median difference is based on the Hodges-Lehmann estimates of shift; The distribution-free 95% CI is based on Wilcoxon's rank sum test statistic."|||-14.7|-22.6|<0.001
72492966|NCT00271817|144514630|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|21.5|STANDARD_ERROR_OF_MEAN|1.8|<|0.001||95.0|18.0|25.0||A fixed sequence testing procedure was employed where testing followed a prespecified order and each subsequent hypothesis was tested at the 0.05 level of significance only if all previously tested hypotheses have been rejected.|ANCOVA|ANCOVA with terms for treatment, baseline LDL-C, baseline TG, and gender.|Mean difference = Ezetimibe/Simvastatin + Niacin minus Niacin|||25.0|18.0|<0.001
72405451|NCT02281552|144318975|NON_INFERIORITY|Non-inferiority of tofacitinib MR 11 mg QD to IR 5 mg BID was concluded if the upper bound of the 2-sided 95% confidence interval of differences between the treatment groups (MR 11 mg QD - IR 5 mg BID) at Week 12 was less than the pre-specified non-inferiority margin of 0.6.|Least Square (LS) mean difference|0.43|STANDARD_ERROR_OF_MEAN|0.13|||TWO_SIDED|95.0|0.17|0.69||||||Analysis was conducted using a linear mixed effect model with repeated measures (MMRM), which included treatment (tofacitinib MR 11 mg QD and IR 5 mg BID), visit, and treatment by visit interaction as fixed effects and participants as a random effect.||0.69|0.17|
72405452|NCT03465878|144319006|SUPERIORITY||Ratio of geometric least squares means|0.999||||0.9813|TWO_SIDED|95.0|0.918|1.09|||Mixed Models Analysis|||||1.09|0.918|0.9813
72405453|NCT03465878|144319006|SUPERIORITY||Ratio of geometric least squares means|1.06||||0.1638|TWO_SIDED|95.0|0.976|1.15|||Mixed Models Analysis|||||1.15|0.976|0.1638
72405454|NCT03465878|144319006|SUPERIORITY||Ratio of geometric least squares means|1.01||||0.7623|TWO_SIDED|95.0|0.933|1.1|||Mixed Models Analysis|||||1.10|0.933|0.7623
72405455|NCT03465878|144319006|SUPERIORITY||Ratio of geometric least squares means|1.04||||0.2952|TWO_SIDED|95.0|0.962|1.13|||Mixed Models Analysis|||||1.13|0.962|0.2952
72405456|NCT03465878|144319006|SUPERIORITY||Ratio of geometric least squares means|0.97||||0.4052|TWO_SIDED|95.0|0.901|1.04|||Mixed Models Analysis|||||1.04|0.901|0.4052
72518421|NCT01617187|144566561|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.9|STANDARD_ERROR_OF_MEAN|1.32||0.5128|TWO_SIDED|95.0|-3.5|1.7||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 42||1.7|-3.5|0.5128
72518422|NCT01617187|144566561|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-2.2|STANDARD_ERROR_OF_MEAN|1.24||0.0842|TWO_SIDED|95.0|-4.6|0.3||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 42||0.3|-4.6|0.0842
72405457|NCT03465878|144319006|SUPERIORITY||Ratio of geometric least squares means|1.02||||0.5314|TWO_SIDED|95.0|0.948|1.11|||Mixed Models Analysis|||||1.11|0.948|0.5314
72405458|NCT03925727|144319038|SUPERIORITY||Mean Difference (Net)|1.4||||0.5533|TWO_SIDED|95.0|-3.2|6.0|||ANCOVA|||||6|-3.2|0.5533
72405459|NCT03925727|144319039|SUPERIORITY||Mean Difference (Net)|-0.6||||0.0192|TWO_SIDED|95.0|-1.1|-0.1|||ANCOVA|||||-0.1|-1.1|0.0192
72518423|NCT01617187|144566561|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-2.4|STANDARD_ERROR_OF_MEAN|1.52||0.1217|TWO_SIDED|95.0|-5.4|0.6||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 42||0.6|-5.4|0.1217
72405460|NCT01393743|144319052|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-30.81||||0.0001|TWO_SIDED|95.0|-45.49|-15.244||The P-value is based on a rank analysis of covariance with treatment and pooled country as factors, and prerandomization seizure frequency as a covariate.|ANCOVA|||The median difference to placebo and the 95% confidence interval are based on the Hodges-Lehmann method.||-15.244|-45.49|0.0001
72405461|NCT01393743|144319053|SUPERIORITY_OR_OTHER|||||||0.0019||||||The P value is based on non-missing values and is from a Cochran-Mantel-Haenszel test stratified by pooled country.|Cochran-Mantel-Haenszel|||||||0.0019
72405462|NCT01393743|144319055|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-23.45||||0.0018|TWO_SIDED|95.0|-40.668|-8.518||The P value is based on a rank analysis of covariance with treatment and pooled country as factors, and prerandomization seizure frequency as a covariate.|ANCOVA|||The median difference to placebo and the 95% confidence interval are based on the Hodges-Lehmann method.||-8.518|-40.668|0.0018
72405463|NCT01393743|144319056|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-12.25||||0.3478|TWO_SIDED|95.0|-53.054|26.989||The P value is based on a rank analysis of covariance with treatment and pooled country as factors, and prerandomization seizure frequency as a covariate.|ANCOVA||The median difference to placebo and the 95% confidence interval are based on the Hodges-Lehmann method.|Median Difference to Placebo for Absence Seizures||26.989|-53.054|0.3478
72405464|NCT01393743|144319056|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|24.87||||0.61|TWO_SIDED|95.0|-15.338|59.938|||ANCOVA|||Median Difference to Placebo for Myoclonic Seizure||59.938|-15.338|0.61
72405465|NCT01393743|144319057|SUPERIORITY_OR_OTHER|||||||0.1826||||||The P value is based on non-missing values and is from a Cochran-Mantel-Haenszel test stratified by pooled country.|Cochran-Mantel-Haenszel|||||||0.1826
72405466|NCT01393743|144319058|SUPERIORITY_OR_OTHER|||||||0.4653|||||||Cochran-Mantel-Haenszel|||P Value Compared to Placebo for Absence Seizures||||0.4653
72405467|NCT01393743|144319058|SUPERIORITY_OR_OTHER|||||||0.3694|||||||Cochran-Mantel-Haenszel|||P Value Compared to Placebo for Myoclonic Seizures||||0.3694
72405468|NCT02321462|144319073|NON_INFERIORITY|Non-inferiority would be demonstrated if the lower limit of the 95% confidence intervals (CI) of the difference was higher than the predefined noninferiority margin (-15%).|Adjusted difference|-0.46|||||TWO_SIDED|95.0|-4.22|3.29|||||To investigate noninferiority of Eziclen compared to Fortrans®, the adjusted difference between these 2 groups was calculated with 95% CI of the adjusted difference.|A multivariate logistic regression model, adjusted on centre, age class (≤65; \>65), gender and IBD status (No IBD, IBD) was used.||3.29|-4.22|
72405469|NCT02321462|144319074|SUPERIORITY||Adjusted difference|0.15|||=|0.0249|TWO_SIDED|95.0|0.02|0.28|||ANOVA|A 2-way analysis of variance model (ANOVA) with covariates for centre, age group (≤65; \>65), gender and IBD status was used.||Treatment difference for Right Colon BBPS Score.||0.28|0.02|=0.0249
72405470|NCT02321462|144319074|SUPERIORITY||Adjusted difference|0.11|||=|0.0382|TWO_SIDED|95.0|0.01|0.22|||ANOVA|A 2-way ANOVA with covariates for centre, age group (≤65; \>65), gender and IBD status was used.||Treatment difference for Transverse Colon BBPS Score.||0.22|0.01|=0.0382
72518424|NCT01617187|144566562|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.7|STANDARD_ERROR_OF_MEAN|0.39||0.0584|TWO_SIDED|95.0|0.0|1.5||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 4||1.5|-0.0|0.0584
72518425|NCT01617187|144566562|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.2|STANDARD_ERROR_OF_MEAN|0.38||0.5197|TWO_SIDED|95.0|-0.5|1.0||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 4||1.0|-0.5|0.5197
72518426|NCT01617187|144566562|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.0|STANDARD_ERROR_OF_MEAN|0.49||0.9693|TWO_SIDED|95.0|-0.9|1.0||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 4||1.0|-0.9|0.9693
72518427|NCT01617187|144566562|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.3|STANDARD_ERROR_OF_MEAN|0.56||0.6161|TWO_SIDED|95.0|-0.8|1.4||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 7||1.4|-0.8|0.6161
72518428|NCT01617187|144566562|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.1|STANDARD_ERROR_OF_MEAN|0.54||0.788|TWO_SIDED|95.0|-1.2|0.9||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 7||0.9|-1.2|0.7880
72405471|NCT02321462|144319074|SUPERIORITY||Adjusted difference|0.06|||=|0.2538|TWO_SIDED|95.0|-0.04|0.16|||ANOVA|A 2-way ANOVA with covariates for centre, age group (≤65; \>65), gender and IBD status was used.||Treatment difference for Left Colon BBPS Score.||0.16|-0.04|=0.2538
72405472|NCT02321462|144319074|SUPERIORITY||Adjusted difference|0.33|||=|0.0256|TWO_SIDED|95.0|0.04|0.62|||ANOVA|A 2-way ANOVA with covariates for centre, age group (≤65; \>65), gender and IBD status was used.||Treatment difference for Global BBPS Score.||0.62|0.04|=0.0256
72405473|NCT02321462|144319075|SUPERIORITY||Adjusted difference|0.11|||=|0.084|TWO_SIDED|95.0|-0.02|0.24|||ANOVA|A 2-way ANOVA with covariates for centre, age group (≤65; \>65), gender and IBD status was used.||Treatment difference for Right Colon BBPS Score (per protocol population).||0.24|-0.02|=0.0840
72405474|NCT02321462|144319075|SUPERIORITY||Treatment difference|0.08|||=|0.132|TWO_SIDED|95.0|-0.02|0.18|||ANOVA|A 2-way ANOVA with covariates for centre, age group (≤65; \>65), gender and IBD status was used.||Treatment difference for Transverse Colon BBPS Score (per protocol population).||0.18|-0.02|=0.1320
72405475|NCT02321462|144319076|SUPERIORITY||Adjusted difference|-6.94|||=|0.2199|TWO_SIDED|95.0|-17.53|3.64|||Regression, Logistic|A multivariate logistic regression model, adjusted on centre, age class (≤65; \>65), gender and IBD status was used.||Treatment difference for detection of polyps.||3.64|-17.53|=0.2199
72518429|NCT01617187|144566562|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.4|STANDARD_ERROR_OF_MEAN|0.7||0.5526|TWO_SIDED|95.0|-1.8|1.0||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 7||1.0|-1.8|0.5526
72518430|NCT01617187|144566562|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.2|STANDARD_ERROR_OF_MEAN|0.67||0.7647|TWO_SIDED|95.0|-1.1|1.5||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 14||1.5|-1.1|0.7647
72405476|NCT02321462|144319076|SUPERIORITY||Adjusted difference|1.87|||=|0.6325|TWO_SIDED|95.0|-6.25|9.99|||Regression, Logistic|A multivariate logistic regression model, adjusted on centre, age class (≤65; \>65), gender and IBD status was used.||Treatment difference for detection of adenomas.||9.99|-6.25|=0.6325
72405477|NCT02321462|144319076|SUPERIORITY||Adjusted difference|-1.55|||=|0.7086|TWO_SIDED|95.0|-9.64|6.54|||Regression, Logistic|A multivariate logistic regression model, adjusted on centre, age class (≤65; \>65), gender and IBD status was used.||Treatment difference for detection of other lesions.||6.54|-9.64|=0.7086
72518431|NCT01617187|144566562|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.1|STANDARD_ERROR_OF_MEAN|0.64||0.89|TWO_SIDED|95.0|-1.2|1.3||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 14||1.3|-1.2|0.8900
72518432|NCT01617187|144566562|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.3|STANDARD_ERROR_OF_MEAN|0.81||0.7097|TWO_SIDED|95.0|-1.9|1.3||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 14||1.3|-1.9|0.7097
72518433|NCT01617187|144566562|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.6|STANDARD_ERROR_OF_MEAN|0.76||0.4601|TWO_SIDED|95.0|-0.9|2.1||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 21||2.1|-0.9|0.4601
72405478|NCT02321462|144319077|SUPERIORITY||Adjusted difference|0.01|||=|0.9927|TWO_SIDED|95.0|-3.12|3.14|||Regression, Logistic|A multivariate logistic regression model, adjusted on centre, age class (≤65; \>65), gender and IBD status was used.||||3.14|-3.12|=0.9927
72405479|NCT02321462|144319078|SUPERIORITY||Adjusted difference|-0.3|||=|0.7039|TWO_SIDED|95.0|-1.88|1.27|||ANOVA|A 2-way ANOVA with covariates for centre, age group (≤65; \>65), gender and IBD status was used.||||1.27|-1.88|=0.7039
72405480|NCT02321462|144319079|SUPERIORITY||Adjusted difference|0.1|||=|0.1891|TWO_SIDED|95.0|-0.05|0.25|||ANOVA|A 2-way ANOVA with covariates for centre, age group (≤65; \>65), gender and IBD status was used.||||0.25|-0.05|=0.1891
72405481|NCT02321462|144319080|SUPERIORITY||Adjusted difference|13.35|||=|0.0011|TWO_SIDED|95.0|6.37|20.32|||Regression, Logistic|A multivariate logistic regression model, adjusted on centre, age class (≤65; \>65), gender and IBD status was used.||||20.32|6.37|=0.0011
72405482|NCT05409235|144319096|SUPERIORITY||difference in percentage of participants|-1.064||||0.573|TWO_SIDED|90.0|-10.578|8.449|||Mantel Haenszel|MH test is adjusted for the randomization stratification factor (Screening DRSS score 47 or 53 or 61B).|A single imputation (non-response) when applying composite variable strategy. MI based for missing data at Week 24, assuming MAR when applying hypothetical strategy. Kept in the analysis when applying treatment policy strategy.|The study was powered to provide a 90% probability to detect a 20% difference between each treatment arm and the combined vehicle control.||8.449|-10.578|0.5730
72405483|NCT05409235|144319096|SUPERIORITY||difference in percentage of participants|-1.152||||0.575|TWO_SIDED|90.0|-11.178|8.874|||Mantel Haenszel|||||8.874|-11.178|0.5750
72405484|NCT05409235|144319097|SUPERIORITY||difference in percentage of participants|3.119||||0.7276|TWO_SIDED|90.0|-5.314|11.592|||Mantel Haenszel|||||11.592|-5.314|0.7276
72405485|NCT05409235|144319097|SUPERIORITY||difference in percentage of participants|5.779||||0.8492|TWO_SIDED|90.0|-3.424|14.982|||Mantel Haenszel|||||14.982|-3.424|0.8492
72518434|NCT01617187|144566562|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.3|STANDARD_ERROR_OF_MEAN|0.72||0.6288|TWO_SIDED|95.0|-1.8|1.1||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 21||1.1|-1.8|0.6288
72518435|NCT01617187|144566562|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.5|STANDARD_ERROR_OF_MEAN|0.91||0.6099|TWO_SIDED|95.0|-2.3|1.3||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 21||1.3|-2.3|0.6099
72518436|NCT01617187|144566562|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.9|STANDARD_ERROR_OF_MEAN|0.82||0.279|TWO_SIDED|95.0|-0.7|2.5||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 28||2.5|-0.7|0.2790
72518437|NCT01617187|144566562|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.6|STANDARD_ERROR_OF_MEAN|0.77||0.4253|TWO_SIDED|95.0|-2.1|0.9||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 28||0.9|-2.1|0.4253
72518438|NCT01617187|144566562|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-1.0|STANDARD_ERROR_OF_MEAN|0.96||0.3014|TWO_SIDED|95.0|-2.9|0.9||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 28||0.9|-2.9|0.3014
72518439|NCT01617187|144566562|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.0|STANDARD_ERROR_OF_MEAN|0.87||0.972|TWO_SIDED|95.0|-1.7|1.7||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 35||1.7|-1.7|0.9720
72518440|NCT01617187|144566562|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.6|STANDARD_ERROR_OF_MEAN|0.82||0.4758|TWO_SIDED|95.0|-2.2|1.0||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 35||1.0|-2.2|0.4758
72518441|NCT01617187|144566562|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.8|STANDARD_ERROR_OF_MEAN|1.03||0.4419|TWO_SIDED|95.0|-2.8|1.2||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 35||1.2|-2.8|0.4419
72518442|NCT01617187|144566562|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.6|STANDARD_ERROR_OF_MEAN|0.91||0.4762|TWO_SIDED|95.0|-2.4|1.1||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 42||1.1|-2.4|0.4762
72518443|NCT01617187|144566562|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-1.4|STANDARD_ERROR_OF_MEAN|0.86||0.1046|TWO_SIDED|95.0|-3.1|0.3||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 42||0.3|-3.1|0.1046
72518444|NCT01617187|144566562|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-1.6|STANDARD_ERROR_OF_MEAN|1.06||0.1411|TWO_SIDED|95.0|-3.7|0.5||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 42||0.5|-3.7|0.1411
72518445|NCT01617187|144566563|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.4|STANDARD_ERROR_OF_MEAN|0.4||0.2754|TWO_SIDED|95.0|-1.2|0.4||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 4||0.4|-1.2|0.2754
72518446|NCT01617187|144566563|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.1|STANDARD_ERROR_OF_MEAN|0.39||0.85|TWO_SIDED|95.0|-0.8|0.7||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 4||0.7|-0.8|0.8500
72518447|NCT01617187|144566563|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.1|STANDARD_ERROR_OF_MEAN|0.51||0.8439|TWO_SIDED|95.0|-1.1|0.9||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 4||0.9|-1.1|0.8439
72518448|NCT01617187|144566563|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.4|STANDARD_ERROR_OF_MEAN|0.51||0.4741|TWO_SIDED|95.0|-1.4|0.6||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 7||0.6|-1.4|0.4741
72518449|NCT01617187|144566563|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.6|STANDARD_ERROR_OF_MEAN|0.49||0.2158|TWO_SIDED|95.0|-1.6|0.4||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 7||0.4|-1.6|0.2158
72518450|NCT01617187|144566563|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.4|STANDARD_ERROR_OF_MEAN|0.63||0.506|TWO_SIDED|95.0|-1.7|0.8||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 7||0.8|-1.7|0.5060
72624855|NCT02541591|144779132|SUPERIORITY||Median ratio of final values|1.37||||0.0881|TWO_SIDED|95.0|0.95|1.98|||ANOVA|due to non normality of the residuals the data were log-transformed prior to the anova|the estimated mean difference obtained using the anova on the log-transformed data was back transformed thus yielding a ratio of median values|missing data were accounted for by multiple imputation||1.98|0.95|0.0881
72624856|NCT01358734|144779144|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.789||||0.119|TWO_SIDED|95.0|0.861|3.718|||Log Rank|||||3.718|0.861|0.119
72518451|NCT01617187|144566563|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.0|STANDARD_ERROR_OF_MEAN|0.56||0.9956|TWO_SIDED|95.0|-1.1|1.1||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 14||1.1|-1.1|0.9956
72518452|NCT01617187|144566563|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.7|STANDARD_ERROR_OF_MEAN|0.53||0.1624|TWO_SIDED|95.0|-1.8|0.3||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 14||0.3|-1.8|0.1624
72518453|NCT01617187|144566563|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.2|STANDARD_ERROR_OF_MEAN|0.68||0.7662|TWO_SIDED|95.0|-1.5|1.1||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 14||1.1|-1.5|0.7662
72518454|NCT01617187|144566563|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.1|STANDARD_ERROR_OF_MEAN|0.61||0.8363|TWO_SIDED|95.0|-1.3|1.1||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 21||1.1|-1.3|0.8363
72518455|NCT01617187|144566563|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.7|STANDARD_ERROR_OF_MEAN|0.58||0.2388|TWO_SIDED|95.0|-1.8|0.5||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 21||0.5|-1.8|0.2388
72518456|NCT01617187|144566563|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.1|STANDARD_ERROR_OF_MEAN|0.73||0.9435|TWO_SIDED|95.0|-1.5|1.4||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 21||1.4|-1.5|0.9435
72518457|NCT01617187|144566563|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.6|STANDARD_ERROR_OF_MEAN|0.7||0.4267|TWO_SIDED|95.0|-0.8|1.9||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 28||1.9|-0.8|0.4267
72518458|NCT01617187|144566563|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.3|STANDARD_ERROR_OF_MEAN|0.65||0.681|TWO_SIDED|95.0|-1.6|1.0||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 28||1.0|-1.6|0.6810
72518459|NCT01617187|144566563|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.2|STANDARD_ERROR_OF_MEAN|0.82||0.7673|TWO_SIDED|95.0|-1.4|1.9||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 28||1.9|-1.4|0.7673
72518460|NCT01617187|144566563|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.5|STANDARD_ERROR_OF_MEAN|0.7||0.483|TWO_SIDED|95.0|-1.9|0.9||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 35||0.9|-1.9|0.4830
72518461|NCT01617187|144566563|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.8|STANDARD_ERROR_OF_MEAN|0.66||0.2128|TWO_SIDED|95.0|-2.1|0.5||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 35||0.5|-2.1|0.2128
72518462|NCT01617187|144566563|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-1.1|STANDARD_ERROR_OF_MEAN|0.83||0.1756|TWO_SIDED|95.0|-2.8|0.5||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 35||0.5|-2.8|0.1756
72518463|NCT01617187|144566563|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.6|STANDARD_ERROR_OF_MEAN|0.72||0.4246|TWO_SIDED|95.0|-0.8|2.0||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 42||2.0|-0.8|0.4246
72518464|NCT01617187|144566563|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.7|STANDARD_ERROR_OF_MEAN|0.68||0.2873|TWO_SIDED|95.0|-2.1|0.6||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 42||0.6|-2.1|0.2873
72518465|NCT01617187|144566563|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.3|STANDARD_ERROR_OF_MEAN|0.83||0.7308|TWO_SIDED|95.0|-1.9|1.4||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 42||1.4|-1.9|0.7308
72518466|NCT01617187|144566564|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.4|STANDARD_ERROR_OF_MEAN|0.32||0.2116|TWO_SIDED|95.0|-0.2|1.0||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 4||1.0|-0.2|0.2116
72518467|NCT01617187|144566564|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.0|STANDARD_ERROR_OF_MEAN|0.31||0.9039|TWO_SIDED|95.0|-0.6|0.7||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 4||0.7|-0.6|0.9039
72518468|NCT01617187|144566564|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.4|STANDARD_ERROR_OF_MEAN|0.4||0.2959|TWO_SIDED|95.0|-1.2|0.4||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 4||0.4|-1.2|0.2959
72518469|NCT01617187|144566564|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.2|STANDARD_ERROR_OF_MEAN|0.44||0.5909|TWO_SIDED|95.0|-1.1|0.6||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 7||0.6|-1.1|0.5909
72518470|NCT01617187|144566564|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.6|STANDARD_ERROR_OF_MEAN|0.42||0.1489|TWO_SIDED|95.0|-1.4|0.2||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 7||0.2|-1.4|0.1489
72518471|NCT01617187|144566564|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.9|STANDARD_ERROR_OF_MEAN|0.54||0.1|TWO_SIDED|95.0|-2.0|0.2||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 7||0.2|-2.0|0.1000
72518472|NCT01617187|144566564|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.1|STANDARD_ERROR_OF_MEAN|0.49||0.783|TWO_SIDED|95.0|-0.8|1.1||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 14||1.1|-0.8|0.7830
72518473|NCT01617187|144566564|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.5|STANDARD_ERROR_OF_MEAN|0.47||0.2679|TWO_SIDED|95.0|-1.4|0.4||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 14||0.4|-1.4|0.2679
72518474|NCT01617187|144566564|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.7|STANDARD_ERROR_OF_MEAN|0.6||0.2321|TWO_SIDED|95.0|-1.9|0.5||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 14||0.5|-1.9|0.2321
72518475|NCT01617187|144566564|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.2|STANDARD_ERROR_OF_MEAN|0.56||0.7368|TWO_SIDED|95.0|-1.3|0.9||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 21||0.9|-1.3|0.7368
72518476|NCT01617187|144566564|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.4|STANDARD_ERROR_OF_MEAN|0.53||0.4606|TWO_SIDED|95.0|-1.4|0.7||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 21||0.7|-1.4|0.4606
72518477|NCT01617187|144566564|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.7|STANDARD_ERROR_OF_MEAN|0.66||0.3241|TWO_SIDED|95.0|-2.0|0.7||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 21||0.7|-2.0|0.3241
72518478|NCT01617187|144566564|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.0|STANDARD_ERROR_OF_MEAN|0.57||0.986|TWO_SIDED|95.0|-1.1|1.1||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 28||1.1|-1.1|0.9860
72569573|NCT02944383|144669972|SUPERIORITY|||||||0.001||||||Results are obtained using a model where outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.0010
72569574|NCT02944383|144669972|SUPERIORITY|||||||0.0407||||||Results are obtained using a model where outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.0407
72518479|NCT01617187|144566564|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.7|STANDARD_ERROR_OF_MEAN|0.53||0.189|TWO_SIDED|95.0|-1.8|0.3||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 28||0.3|-1.8|0.1890
72518480|NCT01617187|144566564|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.7|STANDARD_ERROR_OF_MEAN|0.67||0.303|TWO_SIDED|95.0|-2.0|0.6||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 28||0.6|-2.0|0.3030
72518481|NCT01617187|144566564|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-1.1|STANDARD_ERROR_OF_MEAN|0.58||0.055|TWO_SIDED|95.0|-2.3|0.0||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 35||0.0|-2.3|0.0550
72518482|NCT01617187|144566564|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-1.1|STANDARD_ERROR_OF_MEAN|0.55||0.0415|TWO_SIDED|95.0|-2.2|0.0||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 35||-0.0|-2.2|0.0415
72569575|NCT02944383|144669972|SUPERIORITY|||||||0.1433||||||Results are obtained using a model where outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.1433
72569576|NCT02944383|144669972|SUPERIORITY|||||||0.2866||||||Results are obtained using a model where outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.2866
72518483|NCT01617187|144566564|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-1.9|STANDARD_ERROR_OF_MEAN|0.69||0.0058|TWO_SIDED|95.0|-3.3|-0.6||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 35||-0.6|-3.3|0.0058
72518484|NCT01617187|144566564|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-1.1|STANDARD_ERROR_OF_MEAN|0.62||0.0691|TWO_SIDED|95.0|-2.3|0.1||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 42||0.1|-2.3|0.0691
72518485|NCT01617187|144566564|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-1.6|STANDARD_ERROR_OF_MEAN|0.58||0.0063|TWO_SIDED|95.0|-2.7|-0.5||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 42||-0.5|-2.7|0.0063
72518486|NCT01617187|144566564|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-2.0|STANDARD_ERROR_OF_MEAN|0.71||0.0056|TWO_SIDED|95.0|-3.4|-0.6||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 42||-0.6|-3.4|0.0056
72518487|NCT01617187|144566565|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.1|STANDARD_ERROR_OF_MEAN|0.34||0.7847|TWO_SIDED|95.0|-0.6|0.8||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 4||0.8|-0.6|0.7847
72405486|NCT05409235|144319098|SUPERIORITY||difference in percentage of participants|-1.863||||0.3097|TWO_SIDED|90.0|-8.036|4.309|||Mantel Haenszel|||||4.309|-8.036|0.3097
72518488|NCT01617187|144566565|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.2|STANDARD_ERROR_OF_MEAN|0.33||0.5859|TWO_SIDED|95.0|-0.5|0.8||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 4||0.8|-0.5|0.5859
72518489|NCT01617187|144566565|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.2|STANDARD_ERROR_OF_MEAN|0.43||0.6413|TWO_SIDED|95.0|-1.0|0.6||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 4||0.6|-1.0|0.6413
72518490|NCT01617187|144566565|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.1|STANDARD_ERROR_OF_MEAN|0.38||0.7307|TWO_SIDED|95.0|-0.6|0.9||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 7||0.9|-0.6|0.7307
72518491|NCT01617187|144566565|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.1|STANDARD_ERROR_OF_MEAN|0.37||0.7176|TWO_SIDED|95.0|-0.6|0.9||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 7||0.9|-0.6|0.7176
72518492|NCT01617187|144566565|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.3|STANDARD_ERROR_OF_MEAN|0.48||0.486|TWO_SIDED|95.0|-1.3|0.6||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 7||0.6|-1.3|0.4860
72624857|NCT01358734|144779144|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.659||||0.014|TWO_SIDED|95.0|1.214|5.822|||Log Rank|||||5.822|1.214|0.014
72492967|NCT00271817|144514631|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-17.6|||<|0.001||95.0|-21.8|-13.6||A fixed sequence testing procedure was employed where testing followed a prespecified order and each subsequent hypothesis was tested at the 0.05 level of significance only if all previously tested hypotheses have been rejected.|ANCOVA|ANCOVA using ranks based on normal scores (Tukey method) with model terms for treatment, baseline LDL-C, baseline TG and gender.|"Median difference = Ezetimibe/Simvastatin + Niacin minus Ezetimibe/Simvastatin~The median difference is based on the Hodges-Lehmann estimates of shift; The distribution-free 95% CI is based on Wilcoxon's rank sum test statistic."|||-13.6|-21.8|<0.001
72518493|NCT01617187|144566565|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.0|STANDARD_ERROR_OF_MEAN|0.41||0.9321|TWO_SIDED|95.0|-0.8|0.8||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 14||0.8|-0.8|0.9321
72518494|NCT01617187|144566565|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.1|STANDARD_ERROR_OF_MEAN|0.39||0.7691|TWO_SIDED|95.0|-0.7|0.9||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 14||0.9|-0.7|0.7691
72624858|NCT01358734|144779144|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.367||||0.356|TWO_SIDED|95.0|0.704|2.653|||Log Rank|||||2.653|0.704|0.356
72624859|NCT05870345|144779179|OTHER|Sample size too small to perform additional statistical tests.|||||||||||||||||Sample size too small to perform additional statistical tests.|||
72624860|NCT05870345|144779180|OTHER|Sample size too small to perform additional statistical tests.|||||||||||||||||Sample size too small to perform additional statistical tests.|||
72624861|NCT03898180|144779193|SUPERIORITY||Hazard Ratio (HR)|0.9||||0.4107|TWO_SIDED|95.0|0.72|1.14||Two-sided p-value based on log rank test stratified on chemotherapy ineligibility, programmed cell death ligand 1 (PD-L1) CPS, and ECOG performance status (PS).|Log Rank||Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified on chemotherapy ineligibility, PD-L1 CPS, and ECOG PS.|||1.14|0.72|0.4107
72624862|NCT03898180|144779194|SUPERIORITY||Hazard Ratio (HR)|1.14||||0.3505|TWO_SIDED|95.0|0.87|1.48||Two-sided p-value based on log rank test stratified on chemotherapy ineligibility, PD-L1 CPS, and ECOG PS.|Log Rank||Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified on chemotherapy ineligibility, PD-L1 CPS, and ECOG PS.|||1.48|0.87|0.3505
72624863|NCT03898180|144779195|SUPERIORITY||Difference in Percentage|4.1|||||TWO_SIDED|95.0|-4.0|12.2|||||Based on Miettinen \& Nurminen method stratified on chemotherapy ineligibility, PD-L1 CPS, and ECOG PS.|||12.2|-4.0|
72492968|NCT00271817|144514632|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-7.3|STANDARD_ERROR_OF_MEAN|1.6|<|0.001||95.0|-10.4|-4.2||A fixed sequence testing procedure was employed where testing followed a prespecified order and each subsequent hypothesis was tested at the 0.05 level of significance only if all previously tested hypotheses have been rejected.|ANCOVA|ANCOVA with terms for treatment, baseline LDL-C, baseline TG, and gender.|Median difference = Ezetimibe/Simvastatin + Niacin minus Ezetimibe/Simvastatin|||-4.2|-10.4|<0.001
72492969|NCT00271817|144514633|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.8|STANDARD_ERROR_OF_MEAN|1.6||0.004||95.0|-8.0|-1.5||A fixed sequence testing procedure was employed where testing followed a prespecified order and each subsequent hypothesis was tested at the 0.05 level of significance only if all previously tested hypotheses have been rejected.|ANCOVA|ANCOVA with terms for treatment, baseline LDL-C, baseline TG, and gender.|Mean difference = Ezetimibe/Simvastatin + Niacin minus Ezetimibe/Simvastatin|||-1.5|-8.0|0.004
72492970|NCT00271817|144514634|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.9|STANDARD_ERROR_OF_MEAN|1.4|<|0.001||95.0|-7.7|-2.1||A fixed sequence testing procedure was employed where testing followed a prespecified order and each subsequent hypothesis was tested at the 0.05 level of significance only if all previously tested hypotheses have been rejected.|ANCOVA|ANCOVA with terms for treatment, baseline LDL-C, baseline TG, and gender.|Mean difference = Ezetimibe/Simvastatin + Niacin minus Niacin|||-2.1|-7.7|<0.001
72492971|NCT00271817|144514635|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-7.7|STANDARD_ERROR_OF_MEAN|1.4|<|0.001||95.0|-10.4|-5.0||A fixed sequence testing procedure was employed where testing followed a prespecified order and each subsequent hypothesis was tested at the 0.05 level of significance only if all previously tested hypotheses have been rejected.|ANCOVA|ANCOVA with terms for treatment, baseline LDL-C, baseline TG, and gender.|Mean difference = Ezetimibe/Simvastatin + Niacin minus Ezetimibe/Simvastatin|||-5.0|-10.4|<0.001
72492972|NCT00931359|144514636|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA|Factors of treatment group and analysis center were considered||||||<0.001
72492973|NCT00931359|144514637|SUPERIORITY_OR_OTHER|||||||0.019||95.0|||||ANOVA|||||||0.019
72624864|NCT03898180|144779198|OTHER||Difference in least squares means|-3.07||||0.182|TWO_SIDED|95.0|-7.57|1.44||Two-sided p-value based on log rank test stratified on chemotherapy ineligibility, PD-L1 CPS, and ECOG PS.|cLDA model||Based on a constrained longitudinal data analysis (cLDA) model with the PRO scores as the response variable with covariates for treatment by study visit interaction, and stratification factors by chemotherapy ineligibility, PD-L1 CPS, and ECOG PS.|||1.44|-7.57|0.182
72624865|NCT03898180|144779199|OTHER||Hazard Ratio (HR)|1.64||||0.0005|TWO_SIDED|95.0|1.24|2.16||Two-sided p-value based on log rank test stratified on chemotherapy ineligibility, PD-L1 CPS, and ECOG PS.|Log Rank||Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by chemotherapy ineligibility, PD-L1 CPS, and ECOG PS.|||2.16|1.24|0.0005
72624866|NCT00928668|144779214|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.157|STANDARD_ERROR_OF_MEAN|0.252|<|0.0001|TWO_SIDED|95.0|0.657|1.657|||Mixed Models Analysis|Adjusted using an analysis of variance with terms for centre, patients within centre, treatment and period (all as fixed effects)|Olo 2 mcg minus Placebo|||1.657|0.657|<0.0001
72492974|NCT01295216|144514741|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.37|||||TWO_SIDED|95.0|-2.15|1.4|||||Systolic blood pressure at 12 months|||1.40|-2.15|
72492975|NCT01295216|144514741|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.01|||||TWO_SIDED|95.0|-1.29|1.32|||||Diastolic blood pressure for 12 months|||1.32|-1.29|
72492976|NCT01411085|144514747|SUPERIORITY||Mean Difference (Final Values)|7.0||||0.317|TWO_SIDED||||||t-test, 2 sided|||The assessment was between baseline and values for last 8 weeks.||||0.317
72492977|NCT03809611|144514748|SUPERIORITY||Mean Difference (Net)|1.6|STANDARD_ERROR_OF_MEAN|1.77||0.1832|TWO_SIDED|90.0|-1.34|4.56||One-sided p-value for treatment difference|Mixed Models Analysis|||||4.56|-1.34|0.1832
72569577|NCT02944383|144669972|SUPERIORITY|||||||0.0056||||||Results are obtained using a model where outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||EOS (average of week 10 and 12)||||0.0056
72569578|NCT02944383|144669972|SUPERIORITY|||||||0.0789||||||Results are obtained using a model where outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||EOS (average of week 10 and 12)||||0.0789
72518495|NCT01617187|144566565|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.3|STANDARD_ERROR_OF_MEAN|0.5||0.5694|TWO_SIDED|95.0|-1.3|0.7||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 14||0.7|-1.3|0.5694
72518496|NCT01617187|144566565|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.3|STANDARD_ERROR_OF_MEAN|0.45||0.5583|TWO_SIDED|95.0|-0.6|1.2||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 21||1.2|-0.6|0.5583
72518497|NCT01617187|144566565|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.1|STANDARD_ERROR_OF_MEAN|0.43||0.7307|TWO_SIDED|95.0|-0.7|1.0||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 21||1.0|-0.7|0.7307
72518498|NCT01617187|144566565|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.7|STANDARD_ERROR_OF_MEAN|0.54||0.1715|TWO_SIDED|95.0|-1.8|0.3||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 21||0.3|-1.8|0.1715
72518499|NCT01617187|144566565|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.4|STANDARD_ERROR_OF_MEAN|0.55||0.4219|TWO_SIDED|95.0|-0.6|1.5||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 28||1.5|-0.6|0.4219
72569579|NCT02944383|144669973|SUPERIORITY|||||||0.0277||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 2||||0.0277
72405487|NCT05409235|144319098|SUPERIORITY||difference in percentage of participants|-1.596||||0.3414|TWO_SIDED|90.0|-8.021|4.829|||Mantel Haenszel|||||4.829|-8.021|0.3414
72518500|NCT01617187|144566565|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.2|STANDARD_ERROR_OF_MEAN|0.52||0.7437|TWO_SIDED|95.0|-0.9|1.2||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 28||1.2|-0.9|0.7437
72518501|NCT01617187|144566565|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.7|STANDARD_ERROR_OF_MEAN|0.65||0.311|TWO_SIDED|95.0|-1.9|0.6||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 28||0.6|-1.9|0.3110
72518502|NCT01617187|144566565|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.0|STANDARD_ERROR_OF_MEAN|0.5||0.9805|TWO_SIDED|95.0|-1.0|1.0||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 35||1.0|-1.0|0.9805
72518503|NCT01617187|144566565|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.1|STANDARD_ERROR_OF_MEAN|0.47||0.8741|TWO_SIDED|95.0|-1.0|0.8||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 35||0.8|-1.0|0.8741
72518504|NCT01617187|144566565|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.6|STANDARD_ERROR_OF_MEAN|0.58||0.3288|TWO_SIDED|95.0|-1.7|0.6||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 35||0.6|-1.7|0.3288
72569580|NCT02944383|144669973|SUPERIORITY|||||||0.2502||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 2||||0.2502
72569581|NCT02944383|144669973|SUPERIORITY|||||||0.0161||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 6||||0.0161
72405488|NCT05409235|144319099|SUPERIORITY||Cox Proportional Hazard|0.899||||0.397|TWO_SIDED|90.0|0.4378|1.8467|||Log Rank|||||1.8467|0.4378|0.397
72405489|NCT05409235|144319099|SUPERIORITY||Cox Proportional Hazard|1.113||||0.605|TWO_SIDED|90.0|0.5596|2.2117|||Log Rank|||||2.2117|0.5596|0.605
72405490|NCT05409235|144319100|SUPERIORITY||difference in percentage of participants|-10.622||||0.0619|TWO_SIDED|90.0|-21.972|0.728|||Mantel Haenszel|||||0.728|-21.972|0.0619
72405491|NCT05409235|144319100|SUPERIORITY||difference in percentage of participants|-4.942||||0.2483|TWO_SIDED|90.0|-16.897|7.013|||Mantel Haenszel|||||7.013|-16.897|0.2483
72405492|NCT05409235|144319101|SUPERIORITY||Cox Proportional Hazard|0.807||||0.237|TWO_SIDED|90.0|0.4675|1.392|||Log Rank|||||1.3920|0.4675|0.237
72405493|NCT05409235|144319101|SUPERIORITY||Cox Proportional Hazard|1.279||||0.766|TWO_SIDED|90.0|0.7795|2.0981|||Log Rank|||||2.0981|0.7795|0.766
72405494|NCT05409235|144319102|SUPERIORITY||difference in percentage of participants|-6.389||||0.2022|TWO_SIDED|90.0|-18.994|6.215|||Mantel Haenszel|||||6.215|-18.994|0.2022
72405495|NCT05409235|144319102|SUPERIORITY||difference in percentage of participants|-1.043||||0.4476|TWO_SIDED|90.0|-14.07|11.984|||Mantel Haenszel|||||11.984|-14.070|0.4476
72405496|NCT05409235|144319103|SUPERIORITY||Hazard Ratio (HR)|0.843||||0.268|TWO_SIDED|90.0|0.533|1.334||log-rank test stratified by randomization stratification factor|Log Rank|||||1.334|0.533|0.268
72518505|NCT01617187|144566565|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.0|STANDARD_ERROR_OF_MEAN|0.56||0.9336|TWO_SIDED|95.0|-1.0|1.1||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 42||1.1|-1.0|0.9336
72518506|NCT01617187|144566565|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.7|STANDARD_ERROR_OF_MEAN|0.52||0.1722|TWO_SIDED|95.0|-1.7|0.3||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 42||0.3|-1.7|0.1722
72518507|NCT01617187|144566565|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.8|STANDARD_ERROR_OF_MEAN|0.64||0.1909|TWO_SIDED|95.0|-2.1|0.4||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 42||0.4|-2.1|0.1909
72518508|NCT01617187|144566566|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.0|STANDARD_ERROR_OF_MEAN|0.37||0.9851|TWO_SIDED|95.0|-0.7|0.7||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 4||0.7|-0.7|0.9851
72518509|NCT01617187|144566566|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.2|STANDARD_ERROR_OF_MEAN|0.36||0.4912|TWO_SIDED|95.0|-0.9|0.5||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 4||0.5|-0.9|0.4912
72518510|NCT01617187|144566566|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.1|STANDARD_ERROR_OF_MEAN|0.46||0.8559|TWO_SIDED|95.0|-1.0|0.8||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 4||0.8|-1.0|0.8559
72405497|NCT05409235|144319103|SUPERIORITY||Hazard Ratio (HR)|1.145||||0.304|TWO_SIDED|90.0|0.738|1.775|||Log Rank|||||1.775|0.738|0.304
72405498|NCT05409235|144319104|SUPERIORITY||Odds Ratio (OR)|1.102||||0.428|TWO_SIDED|90.0|0.4573|2.657|||odds ratio|Odds ratio and p-value are from a proportional odds model with covariates for treatment group and the randomization stratification factor||||2.6570|0.4573|0.428
72405499|NCT05409235|144319104|SUPERIORITY||Odds Ratio (OR)|1.119||||0.419|TWO_SIDED|90.0|0.45|2.7846|||odds ratio|Odds ratio and p-value are from a proportional odds model with covariates for treatment group and the randomization stratification factor||||2.7846|0.4500|0.419
72405500|NCT05409235|144319105|SUPERIORITY||difference in percentage of participants|-1.544||||0.6716|TWO_SIDED|90.0|-7.26|4.172|||Mantel Haenszel|||||4.172|-7.260|0.6716
72405501|NCT05409235|144319105|SUPERIORITY||difference in percentage of participants|-3.412||||0.8414|TWO_SIDED|90.0|-9.025|2.2|||Mantel Haenszel|||||2.200|-9.025|0.8414
72405502|NCT05409235|144319106|SUPERIORITY||Mean Difference (Net)|-0.5325||||0.647|TWO_SIDED|90.0|-2.8478|1.7827|||ANCOVA|||||1.7827|-2.8478|0.647
72405503|NCT05409235|144319106|SUPERIORITY||Mean Difference (Net)|-2.2849||||0.945|TWO_SIDED|90.0|-4.6356|0.0658|||ANCOVA|||||0.0658|-4.6356|0.945
72405504|NCT05409235|144319107|SUPERIORITY||Odds Ratio (OR)|1.108||||0.367|TWO_SIDED|90.0|0.6722|1.8276|||odds ratio|Odds ratio and p-value are from a proportional odds model with covariates for treatment group and the randomization stratification factor||||1.8276|0.6722|0.367
72405505|NCT05409235|144319107|SUPERIORITY||Odds Ratio (OR)|0.717||||0.857|TWO_SIDED|90.0|0.4295|1.1981|||odds ratio|Odds ratio and p-value are from a proportional odds model with covariates for treatment group and the randomization stratification factor||||1.1981|0.4295|0.857
72405506|NCT05409235|144319108|SUPERIORITY||Mean Difference (Net)|4.1531||||0.437|TWO_SIDED|90.0|-38.793|47.0991|||ANCOVA|||||47.0991|-38.7930|0.437
72405507|NCT05409235|144319108|SUPERIORITY||Mean Difference (Net)|-16.2461||||0.733|TWO_SIDED|90.0|-59.2538|26.7616|||ANCOVA|||||26.7616|-59.2538|0.733
72405508|NCT05409235|144319109|SUPERIORITY||Mean Difference (Net)|4.0634||||0.77|TWO_SIDED|90.0|-4.9712|13.098|||ANCOVA|||||13.0980|-4.9712|0.770
72405509|NCT05409235|144319109|SUPERIORITY||Mean Difference (Net)|-1.0507||||0.424|TWO_SIDED|90.0|-10.1046|8.0032|||ANCOVA|||||8.0032|-10.1046|0.424
72518511|NCT01617187|144566566|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.2|STANDARD_ERROR_OF_MEAN|0.41||0.5635|TWO_SIDED|95.0|-0.6|1.1||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 7||1.1|-0.6|0.5635
72518512|NCT01617187|144566566|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.5|STANDARD_ERROR_OF_MEAN|0.4||0.2321|TWO_SIDED|95.0|-1.3|0.3||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 7||0.3|-1.3|0.2321
72518513|NCT01617187|144566566|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.1|STANDARD_ERROR_OF_MEAN|0.52||0.8867|TWO_SIDED|95.0|-1.1|0.9||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 7||0.9|-1.1|0.8867
72518514|NCT01617187|144566566|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.6|STANDARD_ERROR_OF_MEAN|0.42||0.1499|TWO_SIDED|95.0|-0.2|1.4||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 14||1.4|-0.2|0.1499
72518515|NCT01617187|144566566|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.4|STANDARD_ERROR_OF_MEAN|0.4||0.286|TWO_SIDED|95.0|-1.2|0.4||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 14||0.4|-1.2|0.2860
72518516|NCT01617187|144566566|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.1|STANDARD_ERROR_OF_MEAN|0.51||0.8978|TWO_SIDED|95.0|-1.1|0.9||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 14||0.9|-1.1|0.8978
72518517|NCT01617187|144566566|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|1.0|STANDARD_ERROR_OF_MEAN|0.44||0.0283|TWO_SIDED|95.0|0.1|1.8||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 21||1.8|0.1|0.0283
72518518|NCT01617187|144566566|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.1|STANDARD_ERROR_OF_MEAN|0.41||0.8667|TWO_SIDED|95.0|-0.7|0.9||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 21||0.9|-0.7|0.8667
72518519|NCT01617187|144566566|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.3|STANDARD_ERROR_OF_MEAN|0.52||0.5044|TWO_SIDED|95.0|-0.7|1.4||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 21||1.4|-0.7|0.5044
72405510|NCT05409235|144319110|SUPERIORITY||Mean Difference (Net)|0.0205||||0.606|TWO_SIDED|90.0|-0.1043|0.1452|||ANCOVA|||||0.1452|-0.1043|0.606
72405511|NCT05409235|144319110|SUPERIORITY||Mean Difference (Net)|0.0083||||0.544|TWO_SIDED|90.0|-0.1161|0.1326|||ANCOVA|||||0.1326|-0.1161|0.544
72405512|NCT05409235|144319111|SUPERIORITY||difference in percentage of participants|-1.544||||0.406|TWO_SIDED|90.0|-12.247|9.158|||Mantel Haenszel|||||9.158|-12.247|0.406
72518520|NCT01617187|144566566|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|1.4|STANDARD_ERROR_OF_MEAN|0.49||0.004|TWO_SIDED|95.0|0.5|2.4||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 28||2.4|0.5|0.0040
72518521|NCT01617187|144566566|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.2|STANDARD_ERROR_OF_MEAN|0.46||0.633|TWO_SIDED|95.0|-0.7|1.1||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 28||1.1|-0.7|0.6330
72518522|NCT01617187|144566566|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.6|STANDARD_ERROR_OF_MEAN|0.57||0.2981|TWO_SIDED|95.0|-0.5|1.7||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 28||1.7|-0.5|0.2981
72518523|NCT01617187|144566566|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.2|STANDARD_ERROR_OF_MEAN|0.45||0.6556|TWO_SIDED|95.0|-0.7|1.1||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 35||1.1|-0.7|0.6556
72518524|NCT01617187|144566566|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.5|STANDARD_ERROR_OF_MEAN|0.43||0.2889|TWO_SIDED|95.0|-1.3|0.4||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 35||0.4|-1.3|0.2889
72518525|NCT01617187|144566566|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.0|STANDARD_ERROR_OF_MEAN|0.53||0.9399|TWO_SIDED|95.0|-1.1|1.0||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 35||1.0|-1.1|0.9399
72518526|NCT01617187|144566566|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.1|STANDARD_ERROR_OF_MEAN|0.54||0.8955|TWO_SIDED|95.0|-1.0|1.1||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 42||1.1|-1.0|0.8955
72518527|NCT01617187|144566566|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.5|STANDARD_ERROR_OF_MEAN|0.51||0.3681|TWO_SIDED|95.0|-1.5|0.5||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 42||0.5|-1.5|0.3681
72518528|NCT01617187|144566566|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.1|STANDARD_ERROR_OF_MEAN|0.62||0.8215|TWO_SIDED|95.0|-1.4|1.1||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 42||1.1|-1.4|0.8215
72518529|NCT02293902|144566577|SUPERIORITY||Odds Ratio (OR)|12.185|||<|0.0001|TWO_SIDED|95.0|5.583|26.594||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||Analysis was performed using Cochran-Mantel-Haenszel (CMH) test stratified by prior biologic use (Yes, No) and weight at screening (\<55 kg, \>=55 kg).|Placebo vs. Sarilumab 150 mg|26.594|5.583|<0.0001
72569582|NCT02944383|144669973|SUPERIORITY|||||||0.6567||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 6||||0.6567
72569583|NCT02944383|144669973|SUPERIORITY|||||||0.001||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.0010
72405513|NCT05409235|144319111|SUPERIORITY||difference in percentage of participants|1.763||||0.605|TWO_SIDED|90.0|-9.114|12.64|||Mantel Haenszel|||||12.640|-9.114|0.605
72405514|NCT05409235|144319112|SUPERIORITY||Hazard Ratio (HR)|0.916||||0.404|TWO_SIDED|90.0|0.5068|1.6556|||Log Rank|||||1.6556|0.5068|0.404
72405515|NCT05409235|144319112|SUPERIORITY||Hazard Ratio (HR)|1.128||||0.624|TWO_SIDED|90.0|0.6399|1.9868|||Log Rank|||||1.9868|0.6399|0.624
72405516|NCT05409235|144319113|SUPERIORITY||Hazard Ratio (HR)|0.947||||0.478|TWO_SIDED|90.0|0.2473|3.6295|||Log Rank|Comparisons are made using the log-rank test stratified by randomization stratification factor.||||3.6295|0.2473|0.478
72405517|NCT05409235|144319113|SUPERIORITY||Hazard Ratio (HR)|1.296||||0.631|TWO_SIDED|90.0|0.3688|4.5512|||Log Rank|Comparisons are made using the log-rank test stratified by randomization stratification factor||||4.5512|0.3688|0.631
72405518|NCT05409235|144319114|SUPERIORITY||difference in percentage of participants|-13.7727||||0.045|TWO_SIDED|90.0|-27.1319|-0.4134|||Mantel Haenszel|||||-0.4134|-27.1319|0.0450
72405519|NCT05409235|144319114|SUPERIORITY||difference in percentage of participants|-3.8234||||0.3304|TWO_SIDED|90.0|-18.1549|10.5081|||Mantel Haenszel|||||10.5081|-18.1549|0.3304
72405520|NCT05409235|144319115|SUPERIORITY||difference in percentage of participants|-14.8877||||0.0275|TWO_SIDED|90.0|-27.6462|-2.1293|||Mantel Haenszel|||||-2.1293|-27.6462|0.0275
72518530|NCT02293902|144566577|SUPERIORITY||Odds Ratio (OR)|7.227|||<|0.0001|TWO_SIDED|95.0|3.446|15.158||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||Analysis was performed using CMH test stratified by prior biologic use (Yes, No) and weight at screening (\<55 kg, \>=55 kg).|Placebo vs. Sarilumab 200 mg|15.158|3.446|<0.0001
72518531|NCT05742841|144566607|SUPERIORITY||Median Difference (Final Values)|-16.5|||||TWO_SIDED|||||||||||||
72518532|NCT03351478|144566629|SUPERIORITY||Difference in Least Square (LS) Means|-0.43|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001|TWO_SIDED|95.0|-0.62|-0.25|||ANCOVA|||The change from baseline to Week 26 is analyzed using an ANCOVA model using multiple imputations to fill in missing data and is parameterized with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of metformin use at screening (Yes, No), randomization strata of mean SBP (\<130, ≥130 mmHg) at screening, and the country as fixed effects, and baseline HbA1c as a covariate.||-0.25|-0.62|< 0.0001
72518533|NCT03351478|144566629|SUPERIORITY||Difference in LS Means|0.12|STANDARD_ERROR_OF_MEAN|0.08||0.145|TWO_SIDED|95.0|-0.04|0.28|||ANCOVA|||The change from baseline to Week 26 is analyzed using an ANCOVA model using multiple imputations to fill in missing data and is parameterized with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of metformin use at screening (Yes, No), randomization strata of mean SBP (\<130, ≥130 mmHg) at screening, and the country as fixed effects, and baseline HbA1c as a covariate.||0.28|-0.04|0.145
72518534|NCT03351478|144566630|SUPERIORITY||Difference in LS Means|-2.05|STANDARD_ERROR_OF_MEAN|1.43||0.1529|TWO_SIDED|95.0|-4.87|0.76|||ANCOVA|||The change from baseline to Week 12 is analyzed using an ANCOVA model using multiple imputations to fill in missing data and is parameterized with treatment groups, randomization strata of HbA1c (≤ 8.5, \>8.5%) at screening, randomization strata of metformin use at screening (Yes, No) and the country as fixed effects, and baseline SBP as a covariate.||0.76|-4.87|0.1529
72518535|NCT03351478|144566630|SUPERIORITY||Difference in LS Means|1.17|STANDARD_ERROR_OF_MEAN|1.21||0.3377|TWO_SIDED|95.0|-1.21|3.55|||ANCOVA|||The change from baseline to Week 12 is analyzed using an ANCOVA model using multiple imputations to fill in missing data and is parameterized with treatment groups, randomization strata of HbA1c (≤ 8.5, \>8.5%) at screening, randomization strata of metformin use at screening (Yes, No) and the country as fixed effects, and baseline SBP as a covariate.||3.55|-1.21|0.3377
72518536|NCT03351478|144566631|SUPERIORITY||Difference in LS Means|-0.91|STANDARD_ERROR_OF_MEAN|0.21|<|0.0001|TWO_SIDED|95.0|-1.33|-0.5|||ANCOVA|||The change from baseline to Week 26 is analyzed using an ANCOVA model using multiple imputations to fill in missing data and is parameterized with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of metformin use at screening (Yes, No), randomization strata of mean SBP (\<130, ≥130 mmHg) at screening, and the country as fixed effects, and baseline 2-hour postprandial glucose as a covariate.||-0.5|-1.33|<0.0001
72518537|NCT03351478|144566631|SUPERIORITY||Difference in LS Means|-0.03|STANDARD_ERROR_OF_MEAN|0.17||0.8397|TWO_SIDED|95.0|-0.37|0.3|||ANCOVA|||The change from baseline to Week 26 is analyzed using an ANCOVA model using multiple imputations to fill in missing data and is parameterized with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of metformin use at screening (Yes, No), randomization strata of mean SBP (\<130, ≥ 130 mmHg) at screening, and the country as fixed effects, and baseline 2-hour postprandial glucose as a covariate.||0.3|-0.37|0.8397
72518538|NCT03351478|144566632|SUPERIORITY||Difference in LS Means|-0.8|STANDARD_ERROR_OF_MEAN|0.23||0.0005|TWO_SIDED|95.0|-1.25|-0.35|||ANCOVA|||The change from baseline to Week 26 is analyzed using an ANCOVA model using multiple imputations to fill in missing data and is parameterized with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of metformin use at screening (Yes, No), randomization strata of mean SBP (\<130, ≥130 mmHg) at screening, and the country as fixed effects, and baseline fasting plasma glucose as a covariate.||-0.35|-1.25|0.0005
72518539|NCT03351478|144566632|SUPERIORITY||Difference in LS Means|0.3|STANDARD_ERROR_OF_MEAN|0.2||0.1339|TWO_SIDED|95.0|-0.09|0.7|||ANCOVA|||The change from baseline to Week 26 is analyzed using an ANCOVA model using multiple imputations to fill in missing data and is parameterized with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of metformin use at screening (Yes, No), randomization strata of mean SBP (\<130, ≥130 mmHg) at screening, and the country as fixed effects, and baseline fasting plasma glucose as a covariate.||0.7|-0.09|0.1339
72518540|NCT03351478|144566633|SUPERIORITY||Difference in LS Means|-2.25|STANDARD_ERROR_OF_MEAN|0.36|<|0.0001|TWO_SIDED|95.0|-2.95|-1.54|||ANCOVA|||The change from baseline to Week 26 is analyzed using an ANCOVA model using multiple imputations to fill in missing data and is parameterized with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of metformin use at screening (Yes, No), randomization strata of mean SBP (\<130, ≥130 mmHg) at screening, and the country as fixed effects, and baseline weight as a covariate.||-1.54|-2.95|<0.0001
72518541|NCT03351478|144566633|SUPERIORITY||Difference in LS Means|0.51|STANDARD_ERROR_OF_MEAN|0.34||0.1407|TWO_SIDED|95.0|-0.17|1.19|||ANCOVA|||The change from baseline to Week 26 is analyzed using an ANCOVA model using multiple imputations to fill in missing data and is parameterized with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of metformin use at screening (Yes, No), randomization strata of mean SBP (\<130, ≥130 mmHg) at screening, and the country as fixed effects, and baseline weight as a covariate.||1.19|-0.17|0.1407
72518542|NCT03351478|144566634|SUPERIORITY||Difference in LS Means|-2.03|STANDARD_ERROR_OF_MEAN|0.95||0.0325|TWO_SIDED|95.0|-3.89|-0.17|||ANCOVA|||The change from baseline to Week 26 is analyzed using an ANCOVA model using multiple imputations to fill in missing data and is parameterized with treatment groups, randomization strata of HbA1c (≤ 8.5, \>8.5%) at screening, randomization strata of metformin use at screening (Yes, No) and the country as fixed effects, and baseline SBP as a covariate.||-0.17|-3.89|0.0325
72518543|NCT03351478|144566634|SUPERIORITY||Difference in LS Means|1.1|STANDARD_ERROR_OF_MEAN|0.78||0.1565|TWO_SIDED|95.0|-0.42|2.63|||ANCOVA|||The change from baseline to Week 26 is analyzed using an ANCOVA model using multiple imputations to fill in missing data and is parameterized with treatment groups, randomization strata of HbA1c (≤ 8.5, \>8.5%) at screening, randomization strata of metformin use at screening (Yes, No) and the country as fixed effects, and baseline SBP as a covariate.||2.63|-0.42|0.1565
72518544|NCT03351478|144566635|SUPERIORITY||percentage difference|8.1||||0.0048|TWO_SIDED|95.0|3.36|12.89|||Cochran-Mantel-Haenszel|||The percentage difference between treatment groups using the Cochran-Mantel-Haenszel test stratified by the randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of metformin use at screening (Yes, No), and the randomization strata of mean SBP (\<130, ≥130 mmHg) at the screening.||12.89|3.36|0.0048
72518545|NCT03351478|144566636|SUPERIORITY||Percentage Difference|16.9||||0.0001|TWO_SIDED|95.0|9.26|24.52|||Cochran-Mantel-Haenszel|||The percentage difference between treatment groups using the Cochran-Mantel-Haenszel test stratified by the randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of metformin use at screening (Yes, No), and the randomization strata of mean SBP (\<130, ≥130 mmHg) at the screening.||24.52|9.26|0.0001
72518546|NCT00510484|144566641|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA|||The parameter was analyzed using an analysis of variance (ANOVA) including treatment, sequence and period as fixed effect and subject within sequence as a random effect.||||<0.001
72518547|NCT00510484|144566642|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA|||The parameter was analyzed using an analysis of variance (ANOVA) including treatment, sequence and period as fixed effect and subject within sequence as a random effect.||||<0.001
72518548|NCT00510484|144566643|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA|||The parameter was analyzed using an analysis of variance (ANOVA) including treatment, sequence and period as fixed effect and subject within sequence as a random effect.||||<0.001
72569584|NCT02944383|144669973|SUPERIORITY|||||||0.1257||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.1257
72405521|NCT05409235|144319115|SUPERIORITY||difference in percentage of participants|-7.5535||||0.179|TWO_SIDED|90.0|-21.0688|5.9617|||Mantel Haenszel|||||5.9617|-21.0688|0.1790
72518549|NCT00510484|144566644|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA|||The parameter was analyzed using an analysis of variance (ANOVA) including treatment, sequence and period as fixed effect and subject within sequence as a random effect.||||<0.001
72518550|NCT00510484|144566645|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA|||The parameter was analyzed using an analysis of variance (ANOVA) including treatment, sequence and period as fixed effect and subject within sequence as a random effect.||||<0.001
72518551|NCT00510484|144566646|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA|||The parameter was analyzed using an analysis of variance (ANOVA) including treatment, sequence and period as fixed effect and subject within sequence as a random effect.||||<0.001
72518552|NCT00510484|144566647|SUPERIORITY_OR_OTHER|||||||0.013||95.0|||||ANOVA|||The parameter was analyzed using an analysis of variance (ANOVA) including treatment, sequence and period as fixed effect and subject within sequence as a random effect.||||0.013
72518553|NCT00510484|144566648|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA|||The parameter was analyzed using an analysis of variance (ANOVA) including treatment, sequence and period as fixed effect and subject within sequence as a random effect.||||<0.001
72518554|NCT00762268|144566656|SUPERIORITY_OR_OTHER|||||||1|||||||Regression, Linear|||||||1.0
72518555|NCT00762268|144566657|OTHER|||||||0.05|||||||Chi-squared|||Change from intake scores.||||0.05
72518556|NCT00762268|144566658|OTHER|||||||0.05|TWO_SIDED|95.0|||||Chi-squared|||||||0.05
72518557|NCT00961441|144566659|SUPERIORITY_OR_OTHER||Point estimate for ratio|1.0271|||||TWO_SIDED|90.0|0.8817|1.1964|||ANOVA|Point estimates for the geometric means ratios children/adults for Cmax normalized by dose and body weight and 90% CIs have been calculated.||An ANOVA for log-transformed values has been used as the basis for calculation of point estimates and Confidence Intervals (CIs).||1.1964|0.8817|
72518558|NCT00961441|144566660|SUPERIORITY_OR_OTHER||Point estimate for ratio|0.9914|||||TWO_SIDED|90.0|0.811|1.2118|||ANOVA|Point estimates for the geometric means ratios children/adults for AUCtau normalized by dose and body weight and 90% CIs have been calculated.||An ANOVA for log-transformed values has been used as the basis for calculation of point estimates and Confidence Intervals (CIs).||1.2118|0.8110|
72518559|NCT00835003|144566707|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations estimated a sample size of 1272 women with an estimated proportion of 8% in the 39 weeks Group and 14% in the 38 weeks group|Risk Ratio (RR)|0.86||||0.31|TWO_SIDED|95.0|0.65|1.15|||Chi-squared|||||1.15|0.65|0.31
72518560|NCT04446299|144566746|NON_INFERIORITY|The predetermined non-inferiority margin was 10%.|Risk Difference (RD)|3.42|||<|0.001|TWO_SIDED|95.0|-1.68|8.52|||Mantel Haenszel|||||8.52|-1.68|<0.001
72518561|NCT03819478|144566747|SUPERIORITY|||||||0.488|||||||ANCOVA|Adjusted for age, sex, race, and baseline bone measure||||||0.4880
72518562|NCT03819478|144566747|SUPERIORITY|||||||0.1683|||||||ANCOVA|Adjusted for age, sex, race, and baseline bone measure||||||0.1683
72518563|NCT03819478|144566748|SUPERIORITY|||||||0.7636|||||||ANCOVA|Adjusted for age, sex, race, and baseline bone measure||||||0.7636
72518564|NCT03819478|144566749|SUPERIORITY|||||||0.1584|||||||ANCOVA|Adjusted for age, sex, race, and baseline bone measure||||||0.1584
72569585|NCT02944383|144669973|SUPERIORITY|||||||0.144||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.1440
72518565|NCT03819478|144566749|SUPERIORITY|||||||0.1623|||||||ANCOVA|Adjusted for age, sex, race, and baseline bone measure||||||0.1623
72518566|NCT03819478|144566750|SUPERIORITY|||||||0.035|||||||ANCOVA|Adjusted for age, sex, race, and baseline bone measure||||||0.0350
72518567|NCT03819478|144566751|SUPERIORITY|||||||0.2422|||||||ANCOVA|Adjusted for age, sex, race, and baseline bone measure||||||0.2422
72518568|NCT03819478|144566751|SUPERIORITY|||||||0.5082|||||||ANCOVA|Adjusted for age, sex, race, and baseline bone measure||||||0.5082
72518569|NCT03819478|144566752|SUPERIORITY|||||||0.5119|||||||ANCOVA|Adjusted for age, sex, race, and baseline bone measure||||||0.5119
72518570|NCT03819478|144566752|SUPERIORITY|||||||0.4902|||||||ANCOVA|Adjusted for age, sex, race, and baseline bone measure||||||0.4902
72405522|NCT00749931|144319116|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Fisher Exact|||||||<0.0001
72518571|NCT03819478|144566753|SUPERIORITY|||||||0.85|||||||ANCOVA|Adjusted for age, sex, race, and baseline bone measure||||||0.8500
72518572|NCT03819478|144566754|SUPERIORITY|||||||0.3685|||||||ANCOVA|Adjusted for age, sex, race, and baseline bone measure||||||0.3685
72518573|NCT03819478|144566754|SUPERIORITY|||||||0.0894|||||||ANCOVA|Adjusted for age, sex, race, and baseline bone measure||||||0.0894
72518574|NCT03819478|144566755|SUPERIORITY|||||||0.5334|||||||ANCOVA|Adjusted for age, sex, race, and baseline bone measure||||||0.5334
72518575|NCT03819478|144566756|SUPERIORITY|||||||0.1573|||||||ANCOVA|Adjusted for age, sex, race, and baseline bone measure||||||0.1573
72518576|NCT01135017|144566770|SUPERIORITY_OR_OTHER||Least Squares (LS) Mean difference|-59.13|STANDARD_ERROR_OF_MEAN|0.275||0.0015|TWO_SIDED|95.0|-76.322|-29.457||No adjustment for multiplicity was made. The priori threshold for statistical significance was ≤0.05.|ANCOVA|ANCOVA model on log-transformed AF burden data with treatment arm as a fixed effect term and baseline log-transformed AF burden as a covariate|"Percent change in AF burden with dronedarone relative to placebo~LS Mean difference from the ANCOVA model on log-transformed AF burden data was exponentiated to convert back to percent change."|"The planned sample size of 286 participants was estimated to have 70% power to detect a reduction in mean AF burden of 30% relative to the placebo group.~Due to the smaller-than-planned sample size, the power to detect this difference was estimated to be only 44%, based on the original assumption. However, the power to detect larger treatment effects (\>40% reduction) remained high and the posthoc power to detect a 60% reduction in AF burden was 99%."||-29.457|-76.322|0.0015
72518577|NCT01148693|144566776|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0|||||Fisher Exact|||Null hypothesis: Adding gentamicin to contrast medium during ERCP has no relation with postERCP cholangitis Power calculation: 80%||||<0.05
72518578|NCT04024072|144566865|EQUIVALENCE|8AM Day 14|Mean Difference (Net)|-0.46|||||TWO_SIDED|95.0|-0.93|0.01||||||||0.01|-0.93|
72518579|NCT04024072|144566865|EQUIVALENCE|10AM Day 14|Mean Difference (Net)|-0.23|||||TWO_SIDED|95.0|-0.7|0.24||||||||0.24|-0.70|
72518580|NCT04024072|144566865|EQUIVALENCE|8AM Day 42|Mean Difference (Net)|-0.24|||||TWO_SIDED|95.0|-0.74|0.27||||||||0.27|-0.74|
72518581|NCT04024072|144566865|EQUIVALENCE|10AM Day 42|Mean Difference (Net)|0.0|||||TWO_SIDED|95.0|-0.51|0.51||||||||0.51|-0.51|
72518582|NCT00091962|144566906|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.001||||0.001|TWO_SIDED|95.0||||repeated measures mixed-effect model with treatment, time (4 time points), and sex; all 2- and 3-factor interaction terms with subject intercepts were treated as a random effect to account for individual differences at randomization.|Mixed Models Analysis|||||||0.001
72518583|NCT01170221|144566909|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the observed difference in the primary outcome measure (early clinical response at the 48-72 Hour Visit) between the tedizolid group and the linezolid group was calculated using the ITT analysis set. Noninferiority was concluded if the lower limit of the 95% CI was greater than -10%.|Risk Difference (RD)|0.1||||||95.0|-6.1|6.2|||||Risk difference corresponds to tedizolid clinical response rate minus linezolid clinical response rate. The confidence interval was calculated using the Miettinen and Nurminen with stratification for the presence or absence of fever at baseline.|The primary objective is to determine the noninferiority in the early clinical response rate of oral tedizolid phosphate compared with that of oral linezolid treatment at the 48-72 Hour Visit in the ITT Analysis Set in patients with ABSSSI.||6.2|-6.1|
72518584|NCT01170221|144566910|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI will be calculated for the observed differences in the clinical response rate based on the sustained response at EOT using the method of Miettinen and Nurminen with stratification for the presence or absence of fever at baseline. Noninferiority was concluded if the lower limit of the 95% CI was greater than -10% and the conditions of the hierarchical testing procedure were met.|Risk Difference (RD)|-2.6|||||TWO_SIDED|95.0|-9.6|4.2||Hierarchical testing procedure of Westfall and Krishen used to control for inflation of the overall type I error rate. If NI is declared for the primary, NI will be tested for the secondary outcomes in this order: Secondary Outcomes Measures 2 to 5.|||Risk difference corresponds to the tedizolid clinical response rate minus the linezolid clinical response rate.|||4.2|-9.6|
72518585|NCT01170221|144566911|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI was calculated for the observed differences in the clinical response rate based on the sustained response at EOT using the method of Miettinen and Nurminen with stratification for the presence or absence of fever at baseline. Noninferiority was concluded if the lower limit of the 95% CI was greater than -10% and the conditions of the hierarchical testing procedure were met.|Risk Difference (RD)|-0.9|||||TWO_SIDED|95.0|-7.7|5.4|||||Risk difference corresponds to the tedizolid clinical response rate minus the linezolid clinical response rate.|||5.4|-7.7|
72518586|NCT01170221|144566912|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI was calculated for the observed differences in the clinical success rate based on the Investigator's assessment of clinical response at the PTE visit using the method of Miettinen and Nurminen with stratification for the presence or absence of fever at baseline. Noninferiority was concluded if the lower limit of the 95% CI was greater than -10% and the conditions of the hierarchical testing procedure were met.|Risk Difference (RD)|-0.5|||||TWO_SIDED|95.0|-5.8|4.9|||||Risk difference corresponds to the tedizolid clinical success rate minus the linezolid clinical success rate.|||4.9|-5.8|
72518587|NCT01170221|144566913|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI was calculated for the observed differences in the clinical success rate based on the Investigator's assessment of clinical response at the PTE visit using the method of Miettinen and Nurminen with stratification for the presence or absence of fever at baseline. Noninferiority was concluded if the lower limit of the 95% CI was greater than -10% and the conditions of the hierarchical testing procedure were met.|Risk Difference (RD)|-0.8|||||TWO_SIDED|95.0|-4.6|3.0|||||Risk difference corresponds to the tedizolid clinical success rate minus the linezolid clinical success rate.|||3.0|-4.6|
72518588|NCT01170221|144566914|SUPERIORITY_OR_OTHER||Risk Difference (RD)|3.5|||||TWO_SIDED|95.0|-1.4|8.5|||||Risk difference corresponds to the tedizolid clinical response rate minus the linezolid clinical response rate.|A two-sided 95% CI was calculated for the observed differences in the clinical response rate based on the Investigator's assessment of clinical response at the 48-72 Hour Visit using the method of Miettinen and Nurminen with stratification for the presence or absence of fever at baseline.||8.5|-1.4|
72518589|NCT01170221|144566915|SUPERIORITY_OR_OTHER||Risk Difference (RD)|1.7|||||TWO_SIDED|95.0|-2.8|6.4|||||Risk difference corresponds to the tedizolid clinical response rate minus the linezolid clinical response rate.|A two-sided 95% CI was calculated for the observed differences in the clinical response rate based on the Investigator's assessment of clinical response at the Day 7 Visit using the method of Miettinen and Nurminen with stratification for the presence or absence of fever at baseline.||6.4|-2.8|
72518590|NCT01488409|144566931|SUPERIORITY_OR_OTHER|||||||0.97|TWO_SIDED||||||t-test, 2 sided|||||||0.97
72518591|NCT01488409|144566932|SUPERIORITY_OR_OTHER|||||||0.85|TWO_SIDED||||||t-test, 2 sided|||||||0.85
72518592|NCT01488409|144566933|SUPERIORITY_OR_OTHER|||||||0.52|TWO_SIDED||||||t-test, 2 sided|||||||0.52
72518593|NCT01488409|144566934|SUPERIORITY_OR_OTHER|||||||0.79|TWO_SIDED||||||t-test, 2 sided|||||||0.79
72518594|NCT01488409|144566935|SUPERIORITY_OR_OTHER|||||||0.007|TWO_SIDED||||||t-test, 2 sided|||||||0.007
72518595|NCT03954444|144566950|EQUIVALENCE|90% Confidence Interval, should be within -20% to +20%|Mean Difference (Net)|2.7|||||TWO_SIDED|90.0|-2.6|8.0||||||||8.0|-2.6|
72518596|NCT03954444|144566950|SUPERIORITY|||||||0.04|||||||Cochran-Mantel-Haenszel|||||||0.04
72518597|NCT03954444|144566950|SUPERIORITY|||||||0.1126|||||||Cochran-Mantel-Haenszel|||||||0.1126
72518598|NCT04491240|144567010|SUPERIORITY||Mean Difference (Net)|73.29|STANDARD_DEVIATION|82.91404||0.020875|TWO_SIDED|95.0|13.97687|132.6031|||t-test, 2 sided|||The study results were statistically processed using STATA version 9.0, Statistica for Windows version 6.0. Changes from the beginning of inhalation and after were compared using the T-test for depended group criterion, data between the main group and the control group were compared using the non-parametric method, box-plot. The data in the table presented as a Mean with full range (min-max). The difference calculated as Mean difference with 95% confidence interval and Standard Deviation (SD)||132.6031|13.97687|0.020875
72569586|NCT02944383|144669973|SUPERIORITY|||||||0.7642||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.7642
72569587|NCT02944383|144669973|SUPERIORITY||Median Difference (Net)|-16.4||||0.0107|TWO_SIDED|95.0|-28.31|-4.51||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|EOS (average of week 10 and 12)||-4.51|-28.31|0.0107
72569588|NCT02944383|144669973|SUPERIORITY||Median Difference (Net)|-5.32||||0.2466|TWO_SIDED|95.0|-16.73|5.52||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|EOS (average of week 10 and 12)||5.52|-16.73|0.2466
72518599|NCT04491240|144567010|SUPERIORITY||Mean Difference (Net)|69.56|STANDARD_DEVIATION|45.67648||0.000953|TWO_SIDED|95.0|36.88502|102.235|||t-test, 2 sided|||The study results were statistically processed using STATA version 9.0, Statistica for Windows version 6.0. Changes from the beginning of inhalation and after were compared using the T-test for depended group criterion, data between the main group and the control group were compared using the non-parametric method, box-plot. The data in the table presented as a Mean with full range (min-max). The difference calculated as Mean difference with 95% confidence interval and Standard Deviation (SD)||102.2350|36.88502|0.000953
72518600|NCT04491240|144567010|SUPERIORITY||Mean Difference (Net)|53.21|STANDARD_DEVIATION|39.85531||0.002233|TWO_SIDED|95.0|24.69923|81.72077|||t-test, 2 sided|||The study results were statistically processed using STATA version 9.0, Statistica for Windows version 6.0. Changes from the beginning of inhalation and after were compared using the T-test for depended group criterion, data between the main group and the control group were compared using the non-parametric method, box-plot. The data in the table presented as a Mean with full range (min-max). The difference calculated as Mean difference with 95% confidence interval and Standard Deviation (SD)||81.72077|24.69923|0.002233
72518601|NCT04491240|144567011|SUPERIORITY||Mean Difference (Net)|331.52|STANDARD_DEVIATION|315.823||0.008948|TWO_SIDED|95.0|105.5938|557.4462|||t-test, 2 sided|||The study results were statistically processed using STATA version 9.0, Statistica for Windows version 6.0. Changes from the beginning of inhalation and after were compared using the T-test for depended group criterion, data between the main group and the control group were compared using the non-parametric method, box-plot. The data in the table presented as a Mean with full range (min-max). The difference calculated as Mean difference with 95% confidence interval and Standard Deviation (SD)||557.4462|105.5938|0.008948
72518602|NCT04491240|144567011|SUPERIORITY||Mean Difference (Net)|366.63|STANDARD_DEVIATION|414.9726||0.020921|TWO_SIDED|95.0|69.77651|663.4835|||t-test, 2 sided|||The study results were statistically processed using STATA version 9.0, Statistica for Windows version 6.0. Changes from the beginning of inhalation and after were compared using the T-test for depended group criterion, data between the main group and the control group were compared using the non-parametric method, box-plot. The data in the table presented as a Mean with full range (min-max). The difference calculated as Mean difference with 95% confidence interval and Standard Deviation (SD)||663.4835|69.77651|0.020921
72518603|NCT04491240|144567011|SUPERIORITY||Mean Difference (Net)|239.2|STANDARD_DEVIATION|204.0934||0.004873|TWO_SIDED|95.0|93.20037|385.1996|||t-test, 2 sided|||The study results were statistically processed using STATA version 9.0, Statistica for Windows version 6.0. Changes from the beginning of inhalation and after were compared using the T-test for depended group criterion, data between the main group and the control group were compared using the non-parametric method, box-plot. The data in the table presented as a Mean with full range (min-max). The difference calculated as Mean difference with 95% confidence interval and Standard Deviation (SD)||385.1996|93.20037|0.004873
72518604|NCT03549117|144567012|SUPERIORITY||Least square (LS) mean difference|0.15||||0.8142|TWO_SIDED|95.0|-1.14|1.45||Between treatment p-values.|ANCOVA|From ANCOVA model, baseline used as a covariate and site as a factor in the model|Difference between treatments of LS mean change from baseline.|Treatment comparison of NRQLQ between active and placebo strip group for Sleep problems.||1.45|-1.14|0.8142
72518605|NCT03549117|144567012|SUPERIORITY||LS mean difference|-0.7||||0.369|TWO_SIDED|95.0|-2.23|0.84||Between treatment p-values.|ANCOVA|From ANCOVA model, baseline used as a covariate and site as a factor in the model.|Difference between treatments of LS mean change from baseline.|Treatment comparison of NRQLQ between active and placebo strip group for Sleep Time Problems.||0.84|-2.23|0.3690
72518606|NCT03549117|144567012|SUPERIORITY||LS mean difference|-0.18||||0.7995|TWO_SIDED|95.0|-1.61|1.25||Between treatment p-values.|ANCOVA|From ANCOVA model, baseline used as a covariate and site as a factor in the model|Difference between treatments of LS mean change from baseline; between treatment 95% CI.|Treatment comparison of NRQLQ between active and placebo strip group for Symptoms on Waking in the Morning.||1.25|-1.61|0.7995
72518607|NCT03549117|144567012|SUPERIORITY||LS mean difference|0.15||||0.7285|TWO_SIDED|95.0|-0.69|0.98||Between treatment p-values.|ANCOVA|From ANCOVA model, baseline used as a covariate and site as a factor in the model|Difference between treatments of LS mean change from baseline.|Treatment comparison of NRQLQ between active and placebo strip group for Practical Problems.||0.98|-0.69|0.7285
72518608|NCT03549117|144567013|SUPERIORITY||LS mean difference|-0.18||||0.7961|TWO_SIDED|95.0|-1.52|1.17||Between treatment p-values.|ANCOVA|From ANCOVA model, baseline used as a covariate and site as a factor in the model|Difference between treatments of LS mean change from baseline.|Treatment comparison of NRQLQ between active and placebo strip group for Sleep problems.||1.17|-1.52|0.7961
72569589|NCT02944383|144669974|SUPERIORITY|||||||0.0211||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 2||||0.0211
72569590|NCT02944383|144669974|SUPERIORITY|||||||0.1304||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 2||||0.1304
72624867|NCT00928668|144779214|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.711|STANDARD_ERROR_OF_MEAN|0.255|<|0.0001|TWO_SIDED|95.0|1.205|2.217|||Mixed Models Analysis|Adjusted using an analysis of variance with terms for centre, patients within centre, treatment and period (all as fixed effects)|Olo 5 mcg minus Placebo|||2.217|1.205|<0.0001
72405523|NCT00749931|144319117|SUPERIORITY_OR_OTHER||Relative reduction|0.47||||0.002|||||||Fisher Exact|||||||0.002
72518609|NCT03549117|144567013|SUPERIORITY||LS mean difference|-0.86||||0.271|TWO_SIDED|95.0|-2.41|0.68||Between treatment p-values.|ANCOVA|From ANCOVA model, baseline used as a covariate and site as a factor in the model|Difference between treatments of LS mean change from baseline.|Treatment comparison of NRQLQ between active and placebo strip group for Sleep time problems.||0.68|-2.41|0.2710
72518610|NCT03549117|144567013|SUPERIORITY||LS mean difference|-0.07||||0.9236|TWO_SIDED|95.0|-1.6|1.45||Between treatment p-values.|ANCOVA|From ANCOVA model, baseline used as a covariate and site as a factor in the model|Difference between treatments of LS mean change from baseline.|Treatment comparison of NRQLQ between active and placebo strip group for symptoms on waking in the morning.||1.45|-1.60|0.9236
72518611|NCT03549117|144567013|SUPERIORITY||LS mean difference|-0.05||||0.8756|TWO_SIDED|95.0|-0.87|0.75||Between treatment p-values.|ANCOVA|From ANCOVA model, baseline used as a covariate and site as a factor in the model|Difference between treatments of LS mean change from baseline.|Treatment comparison of NRQLQ between active and placebo strip group for practical problems.||0.75|-0.87|0.8756
72518612|NCT03549117|144567014|SUPERIORITY||LS mean difference|0.02||||0.9314|TWO_SIDED|95.0|-0.38|0.42||Between treatment p-values.|ANCOVA|From ANCOVA model, baseline used as a covariate and site as a factor in the model|Difference between treatments of LS mean change from baseline.|Treatment comparison of Symptoms on Waking in the Morning in NRQLQ between active and placebo strip group for feel tired and unrefreshed.||0.42|-0.38|0.9314
72518613|NCT03549117|144567014|SUPERIORITY||LS mean difference|-0.05||||0.8005|TWO_SIDED|95.0|-0.45|0.35||Between treatment p-values.|ANCOVA|From ANCOVA model, baseline used as a covariate and site as a factor in the model.|Difference between treatments of LS mean change from baseline.|Treatment comparison of Symptoms on Waking in the Morning in NRQLQ between active and placebo strip group for nasal congestion or stuffy nose.||0.35|-0.45|0.8005
72518614|NCT03549117|144567014|SUPERIORITY||LS mean difference|0.01||||0.9613|TWO_SIDED|95.0|-0.38|0.4||Between treatment p-values.|ANCOVA|From ANCOVA model, baseline used as a covariate and site as a factor in the model.|Difference between treatments of LS mean change from baseline.|Treatment comparison of Symptoms on Waking in the Morning in NRQLQ between active and placebo strip group for congestion in sinuses.||0.40|-0.38|0.9613
72518615|NCT03549117|144567014|SUPERIORITY||LS mean difference|-0.14||||0.4966|TWO_SIDED|95.0|-0.54|0.26||Between treatment p-values.|ANCOVA|From ANCOVA model, baseline used as a covariate and site as a factor in the model|Difference between treatments of LS mean change from baseline.|Treatment comparison of Symptoms on Waking in the Morning in NRQLQ between active and placebo strip group for time to clear nighttime drainage after waking up.||0.26|-0.54|0.4966
72518616|NCT03549117|144567015|SUPERIORITY||LS mean difference|0.03||||0.8775|TWO_SIDED|95.0|-0.39|0.45||Between treatment p-values.|ANCOVA|From ANCOVA model, baseline used as a covariate and site as a factor in the model.|Difference between treatments of LS mean change from baseline.|Treatment comparison of Symptoms on Waking in the Morning in NRQLQ between active and placebo strip group for feel tired and unrefreshed.||0.45|-0.39|0.8775
72518617|NCT03549117|144567015|SUPERIORITY||LS mean difference|-0.06||||0.7747|TWO_SIDED|95.0|-0.47|0.35||Between treatment p-values.|ANCOVA|From ANCOVA model, baseline used as a covariate and site as a factor in the model|Difference between treatments of LS mean change from baseline.|Treatment comparison of Symptoms on Waking in the Morning in NRQLQ between active and placebo strip group for nasal congestion or stuffy nose.||0.35|-0.47|0.7747
72518618|NCT03549117|144567015|SUPERIORITY||LS mean difference|0.04||||0.8535|TWO_SIDED|95.0|-0.39|0.47||Between treatment p-values.|ANCOVA|From ANCOVA model, baseline used as a covariate and site as a factor in the model.|Difference between treatments of LS mean change from baseline.|Treatment comparison of Symptoms on Waking in the Morning in NRQLQ between active and placebo strip group for congestion in sinuses.||0.47|-0.39|0.8535
72518619|NCT03549117|144567015|SUPERIORITY||LS mean difference|-0.06||||0.772|TWO_SIDED|95.0|-0.47|0.35||Between treatment p-values.|ANCOVA|From ANCOVA model, baseline used as a covariate and site as a factor in the model.|Difference between treatments of LS mean change from baseline.|Treatment comparison of Symptoms on Waking in the Morning in NRQLQ between active and placebo strip group for time to clear nighttime drainage after waking up.||0.35|-0.47|0.7720
72518620|NCT03549117|144567016|SUPERIORITY|||||||0.9258|||||||Chi-squared|P-value are based on chi-square test||Treatment comparison of participants showing improvement based on NRQLQ on all of the items in sleep problems.||||0.9258
72518621|NCT03549117|144567016|SUPERIORITY|||||||0.2368|||||||Chi-squared|P-value are based on chi-square test.||Treatment comparison of participants showing improvement based on NRQLQ on any of the items in sleep problems.||||0.2368
72518622|NCT03549117|144567016|SUPERIORITY|||||||0.4432|||||||Chi-squared|P-value are based on chi-square test||Treatment comparison of participants showing improvement based on NRQLQ on all of the items in sleep time problems.||||0.4432
72518623|NCT03549117|144567016|SUPERIORITY|||||||0.9856|||||||Chi-squared|P-value are based on chi-square test||Treatment comparison of participants showing improvement based on NRQLQ on any of the items in sleep time problems.||||0.9856
72518624|NCT03549117|144567016|SUPERIORITY|||||||0.7854|||||||Chi-squared|P-value are based on chi-square test.||Treatment comparison of participants showing improvement based on NRQLQ on all of the items in symptoms on waking in AM.||||0.7854
72518625|NCT03549117|144567016|SUPERIORITY|||||||0.4141|||||||Chi-squared|P-value are based on chi-square test||Treatment comparison of participants showing improvement based on NRQLQ on any of the items in symptoms on waking in AM.||||0.4141
72518626|NCT03549117|144567016|SUPERIORITY|||||||0.3028|||||||Chi-squared|P-value are based on chi-square test||Treatment comparison of participants showing improvement based on NRQLQ on all of the items in practical problems.||||0.3028
72518627|NCT03549117|144567016|SUPERIORITY|||||||0.3955|||||||Chi-squared|P-value are based on chi-square test||Treatment comparison of participants showing improvement based on NRQLQ on any of the items in practical problems.||||0.3955
72518628|NCT03549117|144567017|SUPERIORITY|||||||0.3826|||||||Chi-squared|P-value are based on chi-square test||Treatment comparison of participants showing improvement based on NRQLQ on all of the items in sleep problems.||||0.3826
72518629|NCT03549117|144567017|SUPERIORITY|||||||0.6251|||||||Chi-squared|P-value are based on chi-square test||Treatment comparison of participants showing improvement based on NRQLQ on any of the items in sleep problems.||||0.6251
72518630|NCT03549117|144567017|SUPERIORITY|||||||0.2381|||||||Chi-squared|P-value are based on chi-square test||Treatment comparison of participants showing improvement based on NRQLQ on all of the items in sleep time problems.||||0.2381
72569591|NCT02944383|144669974|SUPERIORITY|||||||0.0318||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 6||||0.0318
72405524|NCT01153581|144319120|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.16|||<|0.05|TWO_SIDED||||||ANOVA|||||||<0.05
72518631|NCT03549117|144567017|SUPERIORITY|||||||0.4245|||||||Chi-squared|P-value are based on chi-square test||Treatment comparison of participants showing improvement based on NRQLQ on any of the items in sleep time problems.||||0.4245
72518632|NCT03549117|144567017|SUPERIORITY|||||||0.8213|||||||Chi-squared|P-value are based on chi-square test||Treatment comparison of participants showing improvement based on NRQLQ on all of the items in symptoms on waking in AM.||||0.8213
72518633|NCT03549117|144567017|SUPERIORITY|||||||0.1823|||||||Chi-squared|P-value are based on chi-square test||Treatment comparison of participants showing improvement based on NRQLQ on any of the items in symptoms on waking in AM.||||0.1823
72518634|NCT03549117|144567017|SUPERIORITY|||||||0.7744|||||||Chi-squared|P-value are based on chi-square test||Treatment comparison of participants showing improvement based on NRQLQ on all of the items in practical problems.||||0.7744
72405525|NCT01282424|144319129|SUPERIORITY||||||<|0.0001||||||The null hypothesis is ≤ 20%.|Exact binomial test|||||||< 0.0001
72405526|NCT03750903|144319157|OTHER|||||||0.05|||||||ANOVA|||||||0.05
72518635|NCT03549117|144567017|SUPERIORITY|||||||0.5811|||||||Chi-squared|P-value are based on chi-square test||Treatment comparison of participants showing improvement based on NRQLQ on any of the items in practical problems.||||0.5811
72569592|NCT02944383|144669974|SUPERIORITY|||||||0.4607||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 6||||0.4607
72405527|NCT00773175|144319210|NON_INFERIORITY|Subcutaneous administration would not be deemed as inferior if the volume infused subcutaneous is ≥85% of the volume infused intravenously.|Mean Difference (Final Values)|-67.5||||0.5064|TWO_SIDED|95.0|-221.2|86.2||P-value for the test of the null hypothesis that the volume delivered via a hylenex-facilitated subcutaneous infusion was ≤85% of the volume delivered intravenously.|ANOVA|Emergency department plus hospital stay|Treatment difference: subcutaneous minus intravenous|||86.2|-221.2|0.5064
72405528|NCT00773175|144319210|NON_INFERIORITY|Subcutaneous administration would not be deemed as inferior if the volume infused subcutaneous is ≥85% of the volume infused intravenously.|Mean Difference (Final Values)|24.0||||0.0325|TWO_SIDED|95.0|-54.6|102.7||P-value for the test of the null hypothesis that the volume delivered via a hylenex-facilitated subcutaneous infusion was ≤85% of the volume delivered intravenously.|ANOVA|Emergency department stay only|Treatment difference: subcutaneous minus intravenous|||102.7|-54.6|0.0325
72492978|NCT03809611|144514749|SUPERIORITY||Odds Ratio (OR)|1.9||||0.283|TWO_SIDED|90.0|0.72|4.78|||Cochran-Mantel-Haenszel|||||4.78|0.72|0.2830
72492979|NCT02926950|144514751|SUPERIORITY||Difference in Least Squares (LS) Means|-0.47|STANDARD_ERROR_OF_MEAN|0.084|<|0.0001|TWO_SIDED|95.0|-0.64|-0.309|||ANCOVA|||The change from baseline to Week 26 is analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.0, \>8.0%) at screening, randomization strata of mean SBP (\<130, ≥130 mmHg) at screening, and country as fixed effects, and baseline HbA1c as a covariate.||-0.309|-0.64|< 0.0001
72492980|NCT02926950|144514752|SUPERIORITY||Difference in LS Means|-1.572|STANDARD_ERROR_OF_MEAN|0.2457|<|0.0001|TWO_SIDED|95.0|-2.0538|-1.0909|||ANCOVA|||The change from baseline to Week 26 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.0, \>8.0%) at screening, randomization strata of mean SBP (\<130, ≥130 mmHg) at screening, and country as fixed effects, and country as fixed effects, and baseline 2- hour postprandial glucose as a covariate.||-1.0909|-2.0538|< 0.0001
72492981|NCT02926950|144514753|SUPERIORITY||Difference in LS Means|-0.76|STANDARD_ERROR_OF_MEAN|0.2247|=|0.0007|TWO_SIDED|95.0|-1.2006|-0.3198|||ANCOVA|||The change from baseline to Week 26 is analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.0, \>8.0%) at screening, randomization strata of mean SBP (\<130, ≥130 mmHg) at screening, and country as fixed effects, and baseline fasting plasma glucose as a covariate.||-0.3198|-1.2006|= 0.0007
72492982|NCT02926950|144514754|SUPERIORITY||Difference in LS Means|-1.87|STANDARD_ERROR_OF_MEAN|0.369|<|0.0001|TWO_SIDED|95.0|-2.591|-1.144|||ANCOVA|||The change from baseline to Week 26 is analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.0, \>8.0%) at screening, randomization strata of mean SBP (\<130, ≥130 mmHg) at screening, and country as fixed effects, and country as fixed effects, and baseline weight as a covariate.||-1.144|-2.591|< 0.0001
72492983|NCT02926950|144514755|SUPERIORITY||Difference in LS Means|-3.28|STANDARD_ERROR_OF_MEAN|1.422|=|0.0209|TWO_SIDED|95.0|-6.07|-0.497|||ANCOVA|||The change from baseline to Week 12 is analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤ 8.0, \>8.0%) at screening, and country as fixed effects, and baseline SBP as a covariate.||-0.497|-6.07|= 0.0209
72492984|NCT02926950|144514756|SUPERIORITY||Difference in LS Means|-3.54|STANDARD_ERROR_OF_MEAN|0.992|=|0.0004|TWO_SIDED|95.0|-5.479|-1.592|||ANCOVA|||The change from baseline to Week 12 is analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤ 8.0, \>8.0%) at screening, randomization strata of mean SBP (\<130, ≥130 mmHg) at screening, and country as fixed effects, and baseline SBP as a covariate.||-1.592|-5.479|= 0.0004
72492985|NCT02926950|144514757|SUPERIORITY||Percentage Difference|5.4|||=|0.0238|TWO_SIDED|95.0|0.75|10.06|||Cochran-Mantel-Haenszel|||Percentage difference between treatment groups using the Cochran-Mantel-Haenszel test stratified by the randomization strata of HbA1c (≤8.0, \>8.0%) at screening, randomization strata of mean SBP (\<130, ≥130 mmHg) at screening. Missing data at Week 26 were assigned a status of nonresponder in the analysis.||10.06|0.75|= 0.0238
72492986|NCT02926950|144514758|SUPERIORITY||Percentage Difference|13.9|||=|0.0001|TWO_SIDED|95.0|6.91|20.89|||Cochran-Mantel-Haenszel|||Percentage difference between treatment groups using the Cochran-Mantel-Haenszel test stratified by the randomization strata of HbA1c (≤8.0, \>8.0%) at screening, randomization strata of mean SBP (\<130, ≥130 mmHg) at screening. Missing data at Week 26 were assigned a status of nonresponder in the analysis.||20.89|6.91|= 0.0001
72405529|NCT00773175|144319211|NON_INFERIORITY|Subcutaneous administration would not be deemed as inferior if the volume infused subcutaneous is ≥85% of the volume infused intravenously.|Mean Difference (Final Values)|-174.7||||0.8915|TWO_SIDED|95.0|-340.3|-9.1||P-value for the test of the null hypothesis that the volume delivered via a hylenex-facilitated subcutaneous infusion was ≤85% of the volume delivered intravenously.|ANOVA|Emergency department plus hospital stay|Treatment difference: subcutaneous minus intravenous|||-9.1|-340.3|0.8915
72405530|NCT00773175|144319211|NON_INFERIORITY|Subcutaneous administration would not be deemed as inferior if the volume infused subcutaneous is ≥85% of the volume infused intravenously.|Mean Difference (Final Values)|-58.6||||0.5469|TWO_SIDED|95.0|-137.5|20.3||P-value for the test of the null hypothesis that the volume delivered via a hylenex-facilitated subcutaneous infusion was ≤85% of the volume delivered intravenously.|ANOVA|Emergency department stay only|Treatment difference: subcutaneous minus intravenous|||20.3|-137.5|0.5469
72518636|NCT05064332|144567023|OTHER||Ratio of Adjusted Geometric Means|101.43|||||TWO_SIDED|90.0|93.01|110.61||||||OC alone as the Reference and co-administration of PF-06650833 and OC as the Test. Natural log transformed AUClast was analyzed using a mixed effects model with treatment as a fixed effect and participant as a random effect. Estimates of the adjusted mean differences (Test-Reference) and corresponding 90% confidence intervals (CIs) were obtained from the model and were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||110.61|93.01|
72518637|NCT05064332|144567024|OTHER||Ratio of Adjusted Geometric Means|108.51|||||TWO_SIDED|90.0|98.85|119.11||||||OC alone as the Reference and co-administration of PF-06650833 and OC as the Test. Natural log transformed AUClast was analyzed using a mixed effects model with treatment as a fixed effect and participant as a random effect. Estimates of the adjusted mean differences (Test-Reference) and corresponding 90% CIs were obtained from the model and were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||119.11|98.85|
72518638|NCT05064332|144567025|OTHER||Ratio of Adjusted Geometric Means|95.07|||||TWO_SIDED|90.0|84.44|107.04||||||OC alone as the Reference and co-administration of PF-06650833 and OC as the Test. Natural log transformed Cmax was analyzed using a mixed effects model with treatment as a fixed effect and participant as a random effect. Estimates of the adjusted mean differences (Test-Reference) and corresponding 90% confidence intervals (CIs) were obtained from the model and were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||107.04|84.44|
72518639|NCT05064332|144567026|OTHER||Ratio of Adjusted Geometric Means|117.99|||||TWO_SIDED|90.0|101.82|136.73||||||OC alone as the Reference and co-administration of PF-06650833 and OC as the Test. Natural log transformed Cmax was analyzed using a mixed effects model with treatment as a fixed effect and participant as a random effect. Estimates of the adjusted mean differences (Test-Reference) and corresponding 90% CIs were obtained from the model and were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||136.73|101.82|
72518640|NCT00523614|144567037|NON_INFERIORITY_OR_EQUIVALENCE|"Size of the study adapted to the use of DNG/EE in female fertile age. Market share of DNG/EE of 13% in Germany. Assuming that 30% of women in the fertile age range were current users of OCs, a prevalence of current use of DNG/EE of about 4% was estimated.~Based on these data the number of cases needed to exclude a twofold increased VTE risk was estimated at about 500-700 cases (based on four controls per case)."|Odds Ratio (OR)|0.89|||<|0.05||95.0|0.57|1.39|||Regression, Logistic|||Null hypothesis: OR ≥ 2 (VTE of DNG/EE vs. other low-dose COC)||1.39|0.57|<0.05
72518641|NCT03296787|144567060|SUPERIORITY|TAK-954 (Total): An analysis of variance (ANOVA) were performed on log transformed Cmax (total TAK-954) to compare moderate renal impairment group with the normal renal function group.||||||0.7265|||||||ANOVA|||||||0.7265
72518642|NCT03296787|144567060|SUPERIORITY|TAK-954 (Total): An ANOVA were performed on log transformed Cmax (total TAK-954) to compare severe renal impairment group with the normal renal function group.||||||0.9839|||||||ANOVA|||||||0.9839
72518643|NCT03296787|144567060|SUPERIORITY|TAK-954 (Free): An ANOVA were performed on natural logarithm of Cmax (free TAK-954) to compare moderate renal impairment group with the normal renal function group.||||||0.9393|||||||ANOVA|||||||0.9393
72518644|NCT03296787|144567060|SUPERIORITY|TAK-954 (Free): An ANOVA were performed on natural logarithm of Cmax (free TAK-954) to compare severe renal impairment group with the normal renal function group.||||||0.1321|||||||ANOVA|||||||0.1321
72518645|NCT03296787|144567061|SUPERIORITY|TAK-954 (Total): An ANOVA were performed on log transformed AUC(0-72) (total TAK-954) to compare moderate renal impairment group with the normal renal function group.||||||0.36|||||||ANOVA|||||||0.3600
72518646|NCT03296787|144567061|SUPERIORITY|TAK-954 (Total): An ANOVA were performed on log transformed AUC(0-72) (total TAK-954) to compare severe renal impairment group with the normal renal function group.||||||0.0816|||||||ANOVA|||||||0.0816
72518647|NCT03296787|144567061|SUPERIORITY|TAK-954 (Free): An ANOVA were performed on natural logarithm of AUC(0-72) (free TAK-954) to compare moderate renal impairment group with the normal renal function group.||||||0.2686|||||||ANOVA|||||||0.2686
72518648|NCT03296787|144567061|SUPERIORITY|TAK-954 (Free): An ANOVA were performed on natural logarithm of AUC(0-72) (free TAK-954) to compare severe renal impairment group with the normal renal function group.||||||0.0059|||||||ANOVA|||||||0.0059
72518649|NCT03296787|144567062|SUPERIORITY|TAK-954 (Total): An ANOVA were performed on log transformed AUClast (total TAK-954) to compare moderate renal impairment group with the normal renal function group.||||||0.0998|||||||ANOVA|||||||0.0998
72518650|NCT03296787|144567062|SUPERIORITY|TAK-954 (Total): An ANOVA were performed on log transformed AUClast (total TAK-954) to compare severe renal impairment group with the normal renal function group.||||||0.0155|||||||ANOVA|||||||0.0155
72518651|NCT03296787|144567062|SUPERIORITY|TAK-954 (Free): An ANOVA were performed on natural logarithm of AUClast (free TAK-954) to compare moderate renal impairment group with the normal renal function group.||||||0.0916|||||||ANOVA|||||||0.0916
72518652|NCT03296787|144567062|SUPERIORITY|TAK-954 (Free): An ANOVA were performed on natural logarithm of AUClast (free TAK-954) to compare severe renal impairment group with the normal renal function group.||||||0.0014|||||||ANOVA|||||||0.0014
72518653|NCT03296787|144567063|SUPERIORITY|TAK-954 (Total): An ANOVA were performed on log transformed AUC∞ (total TAK-954) to compare moderate renal impairment group with the normal renal function group.||||||0.0038|||||||ANOVA|||||||0.0038
72518654|NCT03296787|144567063|SUPERIORITY|TAK-954 (Total): An ANOVA were performed on log transformed AUC∞ (total TAK-954) to compare severe renal impairment group with the normal renal function group.||||||0.0004|||||||ANOVA|||||||0.0004
72518655|NCT03296787|144567063|SUPERIORITY|TAK-954 (Free): An ANOVA were performed on natural logarithm of AUC∞ (free TAK-954) to compare moderate renal impairment group with the normal renal function group.||||||0.0389|||||||ANOVA|||||||0.0389
72518656|NCT03296787|144567063|SUPERIORITY|TAK-954 (Free): An ANOVA were performed on natural logarithm of AUC∞ (free TAK-954) to compare severe renal impairment group with the normal renal function group.||||||0.0011|||||||ANOVA|||||||0.0011
72518657|NCT01626989|144567075|NON_INFERIORITY_OR_EQUIVALENCE|Friedman Test comparing all 3 nights||||||0.001|||||||nonparametric Wilcoxon Signed Rank test|||||||.001
72518658|NCT01432457|144567089|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|1.57||||0.006|TWO_SIDED|95.0|0.44|2.69||A Hochberg step-up procedure was used to control for the multiplicity associated with multiple active dose arms.|Mixed Models Analysis|||A mixed effects model for repeated measures (MMRM) with treatment, visit, treatment by visit interaction, and site as fixed effects, and the baseline HAM-D17 score as a covariate was used to compare DVS SR dose to placebo. The test of the null hypothesis was used study-wise with alpha = 0.05 (2-sided).||2.69|0.44|0.006
72518659|NCT01432457|144567089|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|1.96|||<|0.001|TWO_SIDED|95.0|0.84|3.08||A Hochberg step-up procedure was used to control for the multiplicity associated with multiple active dose arms.|Mixed Models Analysis|||A mixed effects model for repeated measures (MMRM) with treatment, visit, treatment by visit interaction, and site as fixed effects, and the baseline HAM-D17 score as a covariate was used to compare DVS SR dose to placebo. The test of the null hypothesis was used study-wise with alpha = 0.05 (2-sided).||3.08|0.84|< 0.001
72518660|NCT01432457|144567090|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|1.36||||0.014|TWO_SIDED|95.0|0.28|2.45|||ANCOVA|||To assess the sensitivity of the results to the missing data assumptions, an analysis of covariance (ANCOVA) model based on the last observation carried forward (LOCF) was used. The test of the null hypothesis was used study-wise with alpha = 0.05 (2-sided).||2.45|0.28|0.014
72518661|NCT01432457|144567090|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|1.67||||0.002|TWO_SIDED|95.0|0.59|2.74|||ANCOVA|||To assess the sensitivity of the results to the missing data assumptions, an analysis of covariance (ANCOVA) model based on the last observation carried forward (LOCF) was used. The test of the null hypothesis was used study-wise with alpha = 0.05 (2-sided).||2.74|0.59|0.002
72518662|NCT01432457|144567091|SUPERIORITY_OR_OTHER|||||||0.029|TWO_SIDED|||||"p-value was obtained from the separate pair-wise Cochran-Mantel-Haenszel test versus placebo for the alternative hypothesis of Row Mean Scores Differences controlling for site."|Cochran-Mantel-Haenszel|||CGI-I was analyzed with the Cochran-Mantel-Haenszel row-mean-score-difference test using ridit scores. Each DVS SR arm was separately compared to placebo controlling for site. The test of the null hypothesis was used study-wise with alpha = 0.05 (2-sided).||||0.029
72518663|NCT01432457|144567091|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||"p-value was obtained from the separate pair-wise Cochran-Mantel-Haenszel test versus placebo for the alternative hypothesis of Row Mean Scores Differences controlling for site."|Cochran-Mantel-Haenszel|||CGI-I was analyzed with the Cochran-Mantel-Haenszel row-mean-score-difference test using ridit scores. Each DVS SR arm was separately compared to placebo controlling for site. The test of the null hypothesis was used study-wise with alpha = 0.05 (2-sided).||||< 0.001
72518664|NCT01432457|144567092|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.2||||0.009|TWO_SIDED|95.0|0.05|0.34|||Mixed Models Analysis|||CGI-S was analyzed using the mixed effects model for repeated measures (MMRM) with treatment, visit, treatment by visit interaction, and site as fixed effects, and the baseline CGI-S score as a covariate. The test of the null hypothesis was used study-wise with alpha = 0.05 (2-sided).||0.34|0.05|0.009
72518665|NCT01432457|144567092|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.28|||<|0.001|TWO_SIDED|95.0|0.13|0.43|||Mixed Models Analysis|||CGI-S was analyzed using the mixed effects model for repeated measures (MMRM) with treatment, visit, treatment by visit interaction, and site as fixed effects, and the baseline CGI-S score as a covariate. The test of the null hypothesis was used study-wise with alpha = 0.05 (2-sided).||0.43|0.13|< 0.001
72518666|NCT01432457|144567093|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.17||||0.062|TWO_SIDED|95.0|-0.01|0.34|||ANCOVA|||To assess the sensitivity of the results to the missing data assumptions, an analysis of covariance (ANCOVA) model based on the last observation carried forward (LOCF) was used. The test of the null hypothesis was used study-wise with alpha = 0.05 (2-sided).||0.34|-0.01|0.062
72518667|NCT01432457|144567093|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.22||||0.014|TWO_SIDED|95.0|0.04|0.39|||ANCOVA|||To assess the sensitivity of the results to the missing data assumptions, an analysis of covariance (ANCOVA) model based on the last observation carried forward (LOCF) was used. The test of the null hypothesis was used study-wise with alpha = 0.05 (2-sided).||0.39|0.04|0.014
72518668|NCT01432457|144567094|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.242||||0.198|TWO_SIDED|95.0|0.893|1.726|||Regression, Logistic|||Response in HAM-D17 was analyzed based on a logistic regression model with treatment and site as fixed factors and the baseline HAM-D17 total score as a covariate. The test of the null hypothesis was used study-wise with alpha = 0.05 (2-sided).||1.726|0.893|0.198
72518669|NCT01432457|144567094|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.378||||0.054|TWO_SIDED|95.0|0.995|1.91|||Regression, Logistic|||Response in HAM-D17 was analyzed based on a logistic regression model with treatment and site as fixed factors and the baseline HAM-D17 total score as a covariate. The test of the null hypothesis was used study-wise with alpha = 0.05 (2-sided).||1.910|0.995|0.054
72518670|NCT01432457|144567095|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.105||||0.615|TWO_SIDED|95.0|0.749|1.631|||Regression, Logistic|||Remission in HAM-D17 was analyzed based on a logistic regression model with treatment and site as fixed factors and the baseline HAM-D17 total score as a covariate. The test of the null hypothesis was used study-wise with alpha = 0.05 (2-sided).||1.631|0.749|0.615
72518671|NCT01432457|144567095|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.412||||0.072|TWO_SIDED|95.0|0.969|2.057|||Regression, Logistic|||Remission in HAM-D17 was analyzed based on a logistic regression model with treatment and site as fixed factors and the baseline HAM-D17 total score as a covariate. The test of the null hypothesis was used study-wise with alpha = 0.05 (2-sided).||2.057|0.969|0.072
72518672|NCT01432457|144567096|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.09||||0.837|TWO_SIDED|95.0|-0.98|0.8||p-value was obtained from the ANCOVA model as change from baseline = Treatment + Site + Gender + Baseline|ANCOVA|||The treatment by gender interaction was first tested using an analysis of covariance (ANCOVA) model with treatment, site, gender, and treatment by gender as factors and the baseline total score as a covariate. The test of the null hypothesis was used study-wise with alpha = 0.05 (2-sided).||0.80|-0.98|0.837
72518673|NCT01432457|144567096|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.32||||0.471|TWO_SIDED|95.0|-1.19|0.55||p-value was obtained from the ANCOVA model as change from baseline = Treatment + Site + Gender + Baseline|ANCOVA|||The treatment by gender interaction was first tested using an analysis of covariance (ANCOVA) model with treatment, site, gender, and treatment by gender as factors and the baseline total score as a covariate. The test of the null hypothesis was used study-wise with alpha = 0.05 (2-sided).||0.55|-1.19|0.471
72518674|NCT02574481|144567097|NON_INFERIORITY|A two-group Farrington-Manning test is used to test the one-sided hypothesis of non-inferiority in proportions.|||||<|0.0001||||||A two-group Farrington-Manning test is used to test the one-sided hypothesis of non-inferiority in proportions. If the P-value from the one-sided Farrington-Manning test is \<0.05, Eluvia is concluded to be non-inferior to Zilver PTX.|Farrington-Manning|||||||<0.0001
72518675|NCT02574481|144567098|NON_INFERIORITY|A two-group Farrington-Manning test is used to test the one-sided hypothesis of non-inferiority in proportions..|||||<|0.0001||||||A two-group Farrington-Manning test is used to test the one-sided hypothesis of non-inferiority in proportions. If the P-value from the one-sided Farrington-Manning test is \<0.05, Eluvia is concluded to be non-inferior to Zilver PTX.|Farrington-Manning|||||||<0.0001
72518676|NCT04134728|144567108|SUPERIORITY||Odds Ratio (OR)|1.38||||0.2868|TWO_SIDED|0.95|0.76|2.48|||Regression, Logistic|OR and corresponding 95%CI are generated from logistic regression model adjusted for Baseline, Treatment Group, Previously Failed Medical Category.||The null hypothesis is that there is no difference between 90 mg dose of GSK3196165 and placebo in the proportion of participants achieving ACR20 response at Week 12 versus the alternative hypothesis that the 90 mg dose of GSK3196165 differs from placebo in the proportion of participants with ACR20 response at Week 12||2.48|0.76|0.2868
72405531|NCT00773175|144319213|NON_INFERIORITY|Subcutaneous administration would not be deemed as inferior if the volume infused subcutaneous is ≥85% of the volume infused intravenously.|Mean Difference (Final Values)|-67.0||||0.5035|TWO_SIDED|95.0|-220.6|86.7||P-value for the test of the null hypothesis that the volume delivered via a hylenex-facilitated subcutaneous infusion was ≤85% of the volume delivered intravenously.|ANOVA|Emergency department plus hospital stay|Treatment difference: subcutaneous minus intravenous|||86.7|-220.6|0.5035
72518677|NCT04134728|144567108|SUPERIORITY||Odds Ratio (OR)|1.75||||0.0596|TWO_SIDED|0.95|0.98|3.15|||Regression, Logistic|OR and corresponding 95%CI are generated from logistic regression model adjusted for Baseline, Treatment Group, Previously Failed Medical Category.||The null hypothesis is that there is no difference between 150 mg dose of GSK3196165 and placebo in the percentage of participants achieving ACR20 response at Week 12 versus the alternative hypothesis that the 150 mg dose of GSK3196165 differs from placebo in the percentage of participants with ACR20 response at Week 12||3.15|0.98|0.0596
72518678|NCT04134728|144567108|SUPERIORITY||Odds Ratio (OR)|2.34||||0.0049|TWO_SIDED|0.95|1.29|4.23|||Regression, Logistic|OR and corresponding 95%CI are generated from logistic regression model adjusted for Baseline, Treatment Group, Previously Failed Medical Category.||The null hypothesis is that there is no difference between 200 mg dose of Sarilumab alternating with placebo every week and placebo in the proportion of participants achieving ACR20 response at Week 12 versus the alternative hypothesis that the 200 mg dose of Sarilumab alternating with placebo every week differs from placebo in the proportion of participants with ACR20 response at Week 12||4.23|1.29|0.0049
72518679|NCT04134728|144567108|SUPERIORITY||Odds Ratio (OR)|0.59||||0.0293|TWO_SIDED|0.95|0.36|0.95|||Regression, Logistic|OR and corresponding 95%CI are generated from logistic regression model adjusted for Baseline, Treatment Group, Previously Failed Medical Category.||The null hypothesis is that there is no difference between 90 mg dose of GSK3196165 and 200 mg dose of sarilumab alternating with placebo every week in the proportion of participants achieving ACR20 response at Week 12 versus the alternative hypothesis that the 90 mg dose of GSK3196165 differs from 200 mg dose of sarilumab alternating with placebo every week in the proportion of participants with ACR20 response at Week 12||0.95|0.36|0.0293
72518680|NCT04134728|144567108|SUPERIORITY||Odds Ratio (OR)|0.75||||0.2308|TWO_SIDED|0.95|0.47|1.2|||Regression, Logistic|OR and corresponding 95%CI are generated from logistic regression model adjusted for Baseline, Treatment Group, Previously Failed Medical Category.||The null hypothesis is that there is no difference between 150 mg dose of GSK3196165 and 200 mg dose of sarilumab alternating with placebo every week in the proportion of participants achieving ACR20 response at Week 12 versus the alternative hypothesis that the 150 mg dose of GSK3196165 differs from 200 mg dose of sarilumab alternating with placebo every week in the proportion of participants with ACR20 response at Week 12||1.20|0.47|0.2308
72518681|NCT01281189|144567220|SUPERIORITY||LS Mean Difference (Final Values)|2.91||||0.8568|TWO_SIDED|95.0|-28.751|34.576|||ANCOVA|Includes treatment as a fixed effect and adjusts for baseline ALSFRS-R total score, duration from sx onset, site of onset, and use of riluzole.||||34.576|-28.751|0.8568
72518682|NCT01281189|144567221|SUPERIORITY||Hazard Ratio (HR)|1.03||||0.8375|TWO_SIDED|95.0|0.75|1.427|||Cox Proportional Hazards model|Adjusted for baseline ALSFRS-R total score, duration from symptom onset to the first dose of study treatment, site of onset, and use of riluzole.|||Hazard Ratio (HR) (Dex/PBO)|1.427|0.750|0.8375
72518683|NCT01281189|144567222|SUPERIORITY||LS Mean Difference (Net)|0.076||||0.9019|TWO_SIDED|95.0|-1.128|1.28|||mixed-effects repeated-measures model|Mixed-effects repeated-measures model with treatment, visit, treatment-by visit interaction, baseline ALSFRS-R score, baseline-by-visit interaction|The mixed-effects repeated-measures model also adjusted for the following covariates: duration from symptom onset, site of onset, and use of riluzole.|||1.280|-1.128|0.9019
72518684|NCT01281189|144567223|SUPERIORITY||Hazard Ratio (HR)|1.04||||0.7715|TWO_SIDED|95.0|0.801|1.348|||Cox Proportional Hazards model|Adjusted for baseline ALSFRS-R total score, duration from symptom onset to the first dose of study treatment, site of onset, and use of riluzole||||1.348|0.801|0.7715
72569593|NCT02944383|144669974|SUPERIORITY|||||||0.0012||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.0012
72569594|NCT02944383|144669974|SUPERIORITY|||||||0.0592||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.0592
72518685|NCT01281189|144567224|SUPERIORITY||Hazard Ratio (HR)|0.98||||0.9033|TWO_SIDED|95.0|0.745|1.298|||Cox Proportional Hazards model|adjusted for baseline ALSFRS-R total score, duration from symptom onset to the first dose of study treatment, site of onset, and use of riluzole||||1.298|0.745|0.9033
72518686|NCT01281189|144567225|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.772|TWO_SIDED|95.0|0.789|1.192|||Cox Proportional Hazards model||Hazard ratio (Dex/PBO)|||1.192|0.789|0.7720
72518687|NCT05355818|144567226|SUPERIORITY||Diff. in proportion of responders in %|37.9|||||TWO_SIDED|||||There are no p-values when performing a Bayesian analysis. Instead, the probability that the difference in the posterior distributions is \> 0 is used.|Bayesian|Historical information from LP0133-1401 (NCT04871711)/LP0133-1402 (NCT04872101) as prior information is used.|There is no confidence interval when performing Bayesian analyses - instead a 95% credibility interval is used: 13.5% to 58.2%.|Based on the primary estimand 'composite'. Data considered non-response after initiation of rescue treatment or after permanent discontinuation of IMP. Missing data imputed as non-response.||||
72518688|NCT05355818|144567227|SUPERIORITY||Diff. in proportion of responders in %|36.4|||||TWO_SIDED|||||There are no p-values when performing a Bayesian analysis. Instead, the probability that the difference in the posterior distributions is \> 0 is used.|Bayesian||There is no confidence interval when performing Bayesian analyses - instead a 95% credibility interval is used: 12.3% to 59.9%.|Primary estimand: Composite. Data considered non-response after initiation of rescue treatment or after permanent discontinuation of IMP. Missing data imputed as non-response.||||
72518689|NCT05355818|144567228|SUPERIORITY||Diff. in proportion of responders in %|31.7|||||TWO_SIDED|||||There are no p-values when performing a Bayesian analysis. Instead, the probability that the difference in the posterior distributions is \> 0 is used.|Bayesian||There is no confidence interval when performing Bayesian analyses - instead a 95% credibility interval is used: 5.6% to 51.1%.|||||
72518690|NCT05355818|144567229|SUPERIORITY||Diff. in proportion of responders in %|31.2|||||TWO_SIDED|||||There are no p-values when performing a Bayesian analysis. Instead, the probability that the difference in the posterior distributions is \> 0 is used.|Bayesian||There is no confidence interval when performing Bayesian analyses - instead a 95% credibility interval is used: 8.7% to 49.4%|||||
72518691|NCT05355818|144567230|SUPERIORITY||Diff. in proportion of responders in %|25.1|||||TWO_SIDED|||||There are no p-values when performing a Bayesian analysis. Instead, the probability that the difference in the posterior distributions is \> 0 is used.|Bayesian||There is no confidence interval when performing Bayesian analyses - instead a 95% credibility interval is used: 3.9% to 42.3%.|Primary estimand: Composite. Data considered non-response after initiation of rescue treatment or after permanent discontinuation of IMP. Missing data imputed as non-response.||||
72518692|NCT05355818|144567231|SUPERIORITY||Risk Difference (RD)|17.47||||0.0054|TWO_SIDED|95.0|5.16|29.78|||Regression, Logistic||Risk difference estimated using logistic regression stratified by baseline IGA-CHE score.|The primary estimand using the composite strategy is used for the analysis. Data is considered non response after initiation of rescue treatment or after permanent discontinuation of IMP. Missing data is imputed as non-response.||29.78|5.16|0.0054
72518693|NCT05355818|144567232|SUPERIORITY||Risk Difference (RD)|21.21||||0.0248|TWO_SIDED|95.0|2.69|39.72|||Regression, Logistic||Risk difference estimated using logistic regression stratified by baseline IGA-CHE score.|The primary estimand using the composite strategy is used for the analysis. Data is considered non response after initiation of rescue treatment or after permanent discontinuation of IMP. Missing data is imputed as non-response.||39.72|2.69|0.0248
72518694|NCT05355818|144567233|SUPERIORITY||Risk Difference (RD)|11.08||||0.332|TWO_SIDED|95.0|-11.3|33.46|||Regression, Logistic||Risk difference estimated using logistic regression stratified by baseline IGA-CHE score.|The primary estimand using the composite strategy is used for the analysis. Data is considered non response after initiation of rescue treatment or after permanent discontinuation of IMP. Missing data is imputed as non-response.||33.46|-11.30|0.3320
72518695|NCT05355818|144567234|SUPERIORITY||Risk Difference (RD)|33.02||||0.0016|TWO_SIDED|95.0|12.51|53.52|||Regression, Logistic||Risk difference estimated using logistic regression stratified by baseline IGA-CHE score.|The primary estimand using the composite strategy is used for the analysis. Data is considered non response after initiation of rescue treatment or after permanent discontinuation of IMP. Missing data is imputed as non-response.||53.52|12.51|0.0016
72518696|NCT05355818|144567235|SUPERIORITY||Mean Difference (Net)|-2.65||||0.0038|TWO_SIDED|95.0|-4.42|-0.88|||ANCOVA|||Primary estimand: Composite. Data considered non-response by using WOCF (including the baseline value) after initiation of rescue treatment or after permanent discontinuation of IMP. Missing data imputed using WOCF (including the baseline value).||-0.88|-4.42|0.0038
72518697|NCT00092677|144567281|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.96||||0.591||95.0|0.826|1.115|||Regression, Cox|Model terms: treatment and baseline peak transaortic jet velocity (as continuous covariate)|Direction of the Comparison: Hazard Ratio of experiencing the endpoint on EZ/Simva 10/40 mg compared to Placebo|||1.115|0.826|0.591
72518698|NCT00092677|144567282|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.973||||0.732||95.0|0.833|1.137|||Regression, Cox|Model terms: treatment and baseline peak transaortic jet velocity (as continuous covariate)|Direction of the Comparison: Hazard Ratio of experiencing the endpoint on EZ/Simva 10/40 mg compared to Placebo|||1.137|0.833|0.732
72569595|NCT02944383|144669974|SUPERIORITY|||||||0.117||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.1170
72569596|NCT02944383|144669974|SUPERIORITY|||||||0.3138||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.3138
72569597|NCT02944383|144669974|SUPERIORITY|||||||0.009||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||EOS (average of week 10 and 12)||||0.0090
72569598|NCT02944383|144669974|SUPERIORITY|||||||0.1317||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||EOS (average of week 10 and 12)||||0.1317
72518699|NCT00092677|144567283|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.78||||0.024||95.0|0.628|0.967|||Regression, Cox|Model terms: treatment and baseline peak transaortic jet velocity (as continuous covariate)|Direction of the Comparison: Hazard Ratio of experiencing the endpoint on EZ/Simva 10/40 mg compared to Placebo|||0.967|0.628|0.024
72518700|NCT00092677|144567284|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.829||||0.344||95.0|0.563|1.222|||Regression, Cox|Model terms: treatment and baseline peak transaortic jet velocity (as continuous covariate)|Direction of the Comparison: Hazard Ratio of experiencing the endpoint on EZ/Simva 10/40 mg compared to Placebo|||1.222|0.563|0.344
72518701|NCT00092677|144567285|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.997||||0.968||95.0|0.842|1.179|||Regression, Cox|Model terms: treatment and baseline peak transaortic jet velocity (as continuous covariate)|Direction of the Comparison: Hazard Ratio of experiencing the endpoint on EZ/Simva 10/40 mg compared to Placebo|||1.179|0.842|0.968
72518702|NCT00092677|144567286|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.088||||0.771||95.0|0.617|1.917|||Regression, Cox|Model terms: treatment and baseline peak transaortic jet velocity (as continuous covariate)|Direction of the Comparison: Hazard Ratio of experiencing the endpoint on EZ/Simva 10/40 mg compared to Placebo|||1.917|0.617|0.771
72518703|NCT00092677|144567287|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.636||||0.147||95.0|0.345|1.173|||Regression, Cox|Model terms: treatment and baseline peak transaortic jet velocity (as continuous covariate)|Direction of the Comparison: Hazard Ratio of experiencing the endpoint on EZ/Simva 10/40 mg compared to Placebo|||1.173|0.345|0.147
72518704|NCT00092677|144567288|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.683||||0.015||95.0|0.503|0.929|||Regression, Cox|Model terms: treatment and baseline peak transaortic jet velocity (as continuous covariate)|Direction of the Comparison: Hazard Ratio of experiencing the endpoint on EZ/Simva 10/40 mg compared to Placebo|||0.929|0.503|0.015
72518705|NCT00092677|144567289|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.456||||||95.0|0.197|1.057||The p-value was not provided as there were less than 40 patients who reported the specific endpoint.|Regression, Cox|Model terms: treatment and baseline peak transaortic jet velocity (as continuous covariate)|Direction of the Comparison: Hazard Ratio of experiencing the endpoint on EZ/Simva 10/40 mg compared to Placebo|||1.057|0.197|
72518706|NCT00092677|144567290|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.608||||||95.0|0.199|1.86||The p-value was not provided as there were less than 40 patients who reported the specific endpoint.|Regression, Cox|Model terms: treatment and baseline peak transaortic jet velocity (as continuous covariate)|Direction of the Comparison: Hazard Ratio of experiencing the endpoint on EZ/Simva 10/40 mg compared to Placebo|||1.860|0.199|
72518707|NCT00092677|144567291|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.124||||0.647||95.0|0.682|1.85|||Regression, Cox|Model terms: treatment and baseline peak transaortic jet velocity (as continuous covariate)|Direction of the Comparison: Hazard Ratio of experiencing the endpoint on EZ/Simva 10/40 mg compared to Placebo|||1.850|0.682|0.647
72518708|NCT00092677|144567292|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.036||||0.799||95.0|0.788|1.363|||Regression, Cox|Model terms: treatment and baseline peak transaortic jet velocity (as continuous covariate)|Direction of the Comparison: Hazard Ratio of experiencing the endpoint on EZ/Simva 10/40 mg compared to Placebo|||1.363|0.788|0.799
72518709|NCT00092677|144567293|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.667||||0.052||95.0|0.996|2.791|||Regression, Cox|Model terms: treatment and baseline peak transaortic jet velocity (as continuous covariate)|Direction of the Comparison: Hazard Ratio of experiencing the endpoint on EZ/Simva 10/40 mg compared to Placebo|||2.791|0.996|0.052
72518710|NCT00092677|144567294|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.504||||0.008||95.0|1.111|2.035|||Regression, Cox|Model terms: treatment and baseline peak transaortic jet velocity (as continuous covariate)|Direction of the Comparison: Hazard Ratio of experiencing the endpoint on EZ/Simva 10/40 mg compared to Placebo|||2.035|1.111|0.008
72569599|NCT02944383|144669975|SUPERIORITY|||||||0.2395||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 2||||0.2395
72569600|NCT02944383|144669975|SUPERIORITY|||||||0.638||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 2||||0.6380
72518711|NCT00092677|144567295|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.006|STANDARD_ERROR_OF_MEAN|0.029||0.829||95.0|-0.063|0.051|||ANCOVA|Model terms: treatment and baseline peak transaortic jet velocity|Direction of the Comparison: EZ/Simva 10/40 mg minus Placebo|||0.051|-0.063|0.829
72518712|NCT00092677|144567296|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-32.1|STANDARD_ERROR_OF_MEAN|0.6|<=|0.001||95.0|-33.3|-31.0|||ANOVA|Model terms: treatment|Direction of the Comparison: EZ/Simva 10/40 mg minus Placebo|||-31.0|-33.3|<=0.001
72518713|NCT00092677|144567297|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-50.0|STANDARD_ERROR_OF_MEAN|0.9|<=|0.001||95.0|-51.8|-48.2|||ANOVA|Model terms: treatment|Direction of the Comparison: EZ/Simva 10/40 mg minus Placebo|||-48.2|-51.8|<=0.001
72518714|NCT00092677|144567298|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.9|STANDARD_ERROR_OF_MEAN|0.8|<=|0.001||95.0|2.4|5.5|||ANOVA|Model terms: treatment|Direction of the Comparison: EZ/Simva 10/40 mg minus Placebo|||5.5|2.4|<=0.001
72518715|NCT00092677|144567299|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-20.0|STANDARD_ERROR_OF_MEAN|1.3|<=|0.001||95.0|-22.6|-17.3|||ANOVA|Model terms: treatment|Direction of the Comparison: EZ/Simva 10/40 mg minus Placebo|||-17.3|-22.6|<=0.001
72518716|NCT01601704|144567300|NON_INFERIORITY_OR_EQUIVALENCE|At the pre-planned 50% interim analysis, a non-inferiority analysis was conducted based on the estimated hazard ratio (NB32/Placebo) for the time to the first confirmed occurrence of MACE. The upper-bound of the 99.7% confidence interval for the hazard ratio was compared to 1.4, the non-inferiority margin.|Cox Proportional Hazard|0.88|||||TWO_SIDED|99.7|0.57|1.34|||||Hazard ratio is based on CPH model with treatment as a factor.|||1.34|0.57|
72518717|NCT01601704|144567301|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.93|||||TWO_SIDED|99.7|0.66|1.33|||||Hazard ratio is based on CPH model with treatment as a factor.|||1.33|0.66|
72518718|NCT01601704|144567302|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.5|||||TWO_SIDED|99.7|0.21|1.19|||||Hazard ratio is based on CPH model with treatment as a factor.|||1.19|0.21|
72518719|NCT01601704|144567303|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.96|||||TWO_SIDED|99.7|0.55|1.67|||||Hazard ratio is based on CPH model with treatment as a factor.|||1.67|0.55|
72518720|NCT01601704|144567304|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.04|||||TWO_SIDED|99.7|0.43|2.55|||||Hazard ratio is based on CPH model with treatment as a factor.|||2.55|0.43|
72518721|NCT01090102|144567305|SUPERIORITY_OR_OTHER|||||||0.63||||||Significant at p\<0.05|t-test, 2 sided|||||||0.63
72518722|NCT01090102|144567306|SUPERIORITY_OR_OTHER|||||||0.77||||||significant at p\<0.05|t-test, 2 sided|||||||0.77
72518723|NCT03518034|144567308|NON_INFERIORITY|Noninferiority margin in terms of HR is 1.5.|Hazard Ratio (HR)|0.96|||||TWO_SIDED|95.0|0.78|1.17|||||HR of AndroGel to placebo and 95% CI were estimated from Cox proportional-hazards regression model, with adjustment for pre-existing CVD.|The hazard ratio (HR) and 2-sided 95% confidence interval (CI) were calculated using a Cox proportional-hazards regression model, with adjustment for pre-existing cardiovascular disease (CVD) status. In this analysis, the time to event for a participant is defined as the time from randomization to the first component event of MACE. If a subject does not experience a MACE during the study, the time is right-censored at the time of participant's last available follow-up observation.||1.17|0.78|
72518724|NCT03518034|144567310|SUPERIORITY||Hazard Ratio (HR)|1.02|||||TWO_SIDED|95.0|0.86|1.21|||||HR of AndroGel to placebo and 2-sided 95% CI were estimated from a Cox proportional-hazards regression model with adjustment of pre-existing CVD status.|The HR and 2-sided 95% CI were calculated using a Cox proportional-hazards regression model, with adjustment for pre-existing CVD status. In this analysis, the time to event for a participant is defined as the time from randomization to the first component event of CV safety endpoint. If a participant does not experience a CV safety endpoint during the study, the time is right-censored at the time of participant's last available follow-up observation.||1.21|0.86|
72518725|NCT03518034|144567311|SUPERIORITY||Hazard Ratio (HR)|1.62|||||TWO_SIDED|95.0|0.39|6.77|||||Discrete-time proportional hazards model with event time intervals based on scheduled visits, and adjusting for prior cardiovascular disease (CVD).|The high grade prostate cancer endpoint was analyzed using a discrete time proportional hazard regression model with event time intervals based on scheduled visits, and adjusting for pre-existing CVD status. The HR of AndroGel to Placebo and its 2-sided 95% CI were provided.||6.77|0.39|
72518726|NCT03518034|144567312|SUPERIORITY|||||||0.011||||||P-value is derived from the omnibus likelihood-ratio chi-square test of the current model versus the null (intercept) model using linear mixed regression model.|linear mixed regression model|Omnibus likelihood-ratio chi-square test from linear mixed regression model||A linear mixed regression model was used to analyze the change in PDQ-Q4 from baseline to months 6, 12, and 24, with the dependent variable being the change in PDQ-Q4 score. The model included fixed effects for treatment, visit, and the interaction between treatment and visit, while adjusting for baseline PDQ-Q4 score and pre-existing CVD status. An unstructured covariance matrix was used to account for correlations among repeated measures within-subject.||||0.011
72518727|NCT03518034|144567312|SUPERIORITY||LS Mean of Difference|0.49|||||TWO_SIDED|95.0|0.19|0.79|||||LS mean difference (AndroGel - Placebo) at month 6 was derived from linear mixed regression model.|Month 6 (results were derived from a linear mixed regression model that had a dependent variable of the change in PDQ-Q4 from baseline to months 6, 12, and 24. The model included fixed effects for treatment, visit, and the interaction between treatment and visit, while adjusting for baseline PDQ-Q4 score and pre-existing CV disease status. Additionally, an unstructured covariance matrix was used to account for correlations among repeated measures within participants).||0.79|0.19|
72518728|NCT03518034|144567312|SUPERIORITY||LS Mean of Difference|0.47|||||TWO_SIDED|95.0|0.11|0.83|||||LS mean difference (AndroGel - Placebo) at month 12 was derived from linear mixed regression model.|Month 12 (results were derived from a linear mixed regression model that had a dependent variable of the change in PDQ-Q4 from baseline to months 6, 12, and 24. The model included fixed effects for treatment, visit, and the interaction between treatment and visit, while adjusting for baseline PDQ-Q4 score and pre-existing CV disease status. Additionally, an unstructured covariance matrix was used to account for correlations among repeated measures within participants).||0.83|0.11|
72518729|NCT03518034|144567312|SUPERIORITY||LS Mean of Difference|0.48|||||TWO_SIDED|95.0|-0.01|0.96|||||LS mean difference (AndroGel - Placebo) at month 24 was derived from linear mixed regression model.|Month 24 (results were derived from a linear mixed regression model that had a dependent variable of the change in PDQ-Q4 from baseline to months 6, 12, and 24. The model included fixed effects for treatment, visit, and the interaction between treatment and visit, while adjusting for baseline PDQ-Q4 score and pre-existing CV disease status. Additionally, an unstructured covariance matrix was used to account for correlations among repeated measures within participants).||0.96|-0.01|
72518730|NCT03518034|144567313|SUPERIORITY||Risk Ratio (RR)|1.92|||||TWO_SIDED|95.0|0.96|3.86||||||Month 6 risk ratio of remission of LG-PDD in the AndroGel versus placebo group was estimated by a repeated measures generalized estimating equations (GEE) Poisson regression model with fixed effects for treatment, visit, treatment-visit interaction, pre- existing CVD, and an unstructured working correlation matrix to account for repeated measures at multiple visits.||3.86|0.96|
72518731|NCT03518034|144567313|SUPERIORITY||Risk Ratio (RR)|1.52|||||TWO_SIDED|95.0|0.64|3.63||||||Month 12 risk ratio of remission of LG-PDD in the AndroGel versus placebo group was estimated by a repeated measures generalized estimating equations (GEE) Poisson regression model with fixed effects for treatment, visit, treatment-visit interaction, pre- existing CVD, and an unstructured working correlation matrix to account for repeated measures at multiple visits.||3.63|0.64|
72518732|NCT03518034|144567313|SUPERIORITY||Risk Ratio (RR)|0.9|||||TWO_SIDED|95.0|0.42|1.94||||||Month 24 risk ratio of remission of LG-PDD in the AndroGel versus placebo group was estimated by a repeated measures generalized estimating equations (GEE) Poisson regression model with fixed effects for treatment, visit, treatment-visit interaction, pre- existing CVD, and an unstructured working correlation matrix to account for repeated measures at multiple visits.||1.94|0.42|
72518733|NCT03518034|144567313|SUPERIORITY|||||||0.197||||||The omnibus test p value is a test of the null hypothesis of no difference between AndroGel and placebo groups across all time points.|GEE Poisson regression model|||Risk ratio of remission of LG-PDD in the TRT versus placebo group was estimated by a repeated measures generalized estimating equations (GEE) Poisson regression model with fixed effects for treatment, visit, treatment-visit interaction, pre- existing CVD, and an unstructured working correlation matrix to account for repeated measures at multiple visits.||||0.197
72569601|NCT02944383|144669975|SUPERIORITY|||||||0.7468||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 6||||0.7468
72518734|NCT03518034|144567315|SUPERIORITY||Hazard Ratio (HR)|1.43|||||TWO_SIDED|95.0|1.04|1.97|||||Cox proportional-hazards model.|The HR and 2-sided 95% CI were calculated using a Cox proportional-hazards regression model, with adjustment for pre-existing CVD status. In this analysis, the time to event for a subject is defined as the time from randomization to the first occurrence of a clinical fracture. If a subject does not experience a clinic fracture during the study, the follow-up time is right-censored at the time of subject's last available follow-up observation.||1.97|1.04|
72405532|NCT00773175|144319213|NON_INFERIORITY|Subcutaneous administration would not be deemed as inferior if the volume infused subcutaneous is ≥85% of the volume infused intravenously.|Mean Difference (Final Values)|24.6||||0.0314|TWO_SIDED|95.0|-54.0|103.2||P-value for the test of the null hypothesis that the volume delivered via a hylenex-facilitated subcutaneous infusion was ≤85% of the volume delivered intravenously.|ANOVA|Emergency department stay only|Treatment difference: subcutaneous minus intravenous|||103.2|-54.0|0.0314
72405533|NCT00773175|144319217|NON_INFERIORITY|Subcutaneous administration would not be deemed as inferior if the volume infused subcutaneous is ≥85% of the volume infused intravenously.|Mean Difference (Final Values)|-30.1|||||TWO_SIDED|95.0|-69.5|9.4|||||Treatment difference: subcutaneous minus intravenous; Emergency department plus hospital stay|||9.4|-69.5|
72405534|NCT00773175|144319217|NON_INFERIORITY|Subcutaneous administration would not be deemed as inferior if the volume infused subcutaneous is ≥85% of the volume infused intravenously.|Mean Difference (Final Values)|-40.2|||||TWO_SIDED|95.0|-77.3|-3.1|||||Treatment difference: subcutaneous minus intravenous; Emergency department stay only|||-3.1|-77.3|
72518735|NCT03518034|144567316|OTHER|||||||0.002||||||p-value is from an omnibus likelihood-ratio chi-square test of the current model versus the null (intercept) model using repeated measure log-binomial regression.|omnibus likelihood-ratio chi-square test|||Repeated measures log-binomial regression with effects for treatment, visit, treatment-by-visit interaction, and adjusted for pre-existing CVD, and an unstructured covariance matrix to account for correlations among repeated measures within-subject.||||0.002
72518736|NCT03518034|144567317|SUPERIORITY|||||||0.494||||||P-value is from an omnibus likelihood-ratio chi-square test of the current model versus the null (intercept) model using repeated measure log-binomial regression.|Repeated measures log-binomial regr.|||The risk ratio of progression to diabetes in the AndroGel versus placebo group was estimated by a repeated measures log-binomial regression with fixed effects for treatment, visit, treatment-visit interaction, and pre-existing CVD, and an unstructured covariance matrix to account for correlations among repeated measures within-subject.||||0.494
72518737|NCT03518034|144567318|SUPERIORITY||Hazard Ratio (HR)|0.98|||||TWO_SIDED|95.0|0.78|1.23|||||Cox proportional-hazards model adjusting for prior CVD.|||1.23|0.78|
72518738|NCT03518034|144567319|SUPERIORITY||Hazard Ratio (HR)|1.11|||||TWO_SIDED|95.0|0.76|1.62|||||Cox proportional-hazards model adjusting for prior CVD.|||1.62|0.76|
72518739|NCT03518034|144567320|SUPERIORITY||Hazard Ratio (HR)|1.46|||||TWO_SIDED|95.0|0.92|2.32|||||Cox proportional-hazards model adjusting for prior CVD.|||2.32|0.92|
72518740|NCT03518034|144567321|SUPERIORITY||Hazard Ratio (HR)|0.92|||||TWO_SIDED|95.0|0.56|1.51|||||Cox proportional-hazards model adjusting for prior CVD.|||1.51|0.56|
72518741|NCT03518034|144567322|SUPERIORITY||Hazard Ratio (HR)|1.13|||||TWO_SIDED|95.0|0.55|2.31|||||Discrete-time proportional hazards model with event time intervals based on scheduled visits, and adjusting for prior CVD.|||2.31|0.55|
72518742|NCT03518034|144567323|SUPERIORITY||Hazard Ratio (HR)|1.07|||||TWO_SIDED|95.0|0.47|2.42|||||Discrete-time proportional hazards model with event time intervals based on scheduled visits, and adjusting for prior CVD.|||2.42|0.47|
72518743|NCT03518034|144567324|SUPERIORITY||Hazard Ratio (HR)|1.25|||||TWO_SIDED|95.0|0.65|2.41|||||Discrete-time proportional hazards model with event time intervals based on scheduled visits, and adjusting for prior CVD.|||2.41|0.65|
72518744|NCT03518034|144567325|SUPERIORITY||Hazard Ratio (HR)|1.16|||||TWO_SIDED|95.0|0.87|1.54|||||Discrete-time proportional hazards model with event time intervals based on scheduled visits, and adjusting for prior CVD.|||1.54|0.87|
72405535|NCT00773175|144319218|NON_INFERIORITY|Subcutaneous administration would not be deemed as inferior if the volume infused subcutaneous is ≥85% of the volume infused intravenously.|Mean Difference (Final Values)|-30.1|||||TWO_SIDED|95.0|-69.5|9.4|||||Treatment difference: subcutaneous minus intravenous; Emergency department plus hospital stay|||9.4|-69.5|
72518745|NCT03518034|144567326|SUPERIORITY||Hazard Ratio (HR)|1.91|||||TWO_SIDED|95.0|0.95|3.84|||||Discrete-time proportional hazards model with event time intervals based on scheduled visits, and adjusting for prior CVD.|||3.84|0.95|
72518746|NCT00010803|144567329|NON_INFERIORITY_OR_EQUIVALENCE|Previously provided|Hazard Ratio (HR)|1.12||||0.21|TWO_SIDED|95.0|0.94|1.33|||Log Rank|Time to dementia in Ginkgo vs placebo groups. The Cox proportional hazards model was used to compute hazard ratios and log-rank tests.||The null hypothesis is that the instantaneous hazard rate for Ginkgo biloba and placebo are the same. Assumptions were based on 4%/yr dementia and 6%/yr mortality and dropout combined. A sample size of 3000 with an average follow up of 5 years resulted in 96% power to detecting a 30% reduction in the rate of dementia at a 2-sided significance level of 0.5.||1.33|0.94|0.21
72518747|NCT00010803|144567330|NON_INFERIORITY_OR_EQUIVALENCE|Previously provided|Hazard Ratio (HR)|1.04||||0.7|TWO_SIDED|95.0|0.85|1.27|||Log Rank|||Total Mortality||1.27|0.85|0.70
72518748|NCT00010803|144567330|NON_INFERIORITY_OR_EQUIVALENCE|Previously provided|Hazard Ratio (HR)|1.06||||0.78|TWO_SIDED|95.0|0.7|1.62|||Log Rank|||Atherosclerotic CHD mortality||1.62|0.70|0.78
72518749|NCT00010803|144567330|NON_INFERIORITY_OR_EQUIVALENCE|Previously provided|Hazard Ratio (HR)|1.12||||0.54|TWO_SIDED|95.0|0.79|1.58|||Log Rank|||Incident Myocardial Infarction||1.58|0.79|0.54
72405536|NCT00773175|144319218|NON_INFERIORITY|Subcutaneous administration would not be deemed as inferior if the volume infused subcutaneous is ≥85% of the volume infused intravenously.|Mean Difference (Final Values)|-40.2|||||TWO_SIDED|95.0|-77.3|-3.1|||||Treatment difference: subcutaneous minus intravenous; Emergency department stay only|||-3.1|-77.3|
72405537|NCT00773175|144319220|NON_INFERIORITY|Subcutaneous administration would not be deemed as inferior if the volume infused subcutaneous is ≥85% of the volume infused intravenously.|Mean Difference (Final Values)|2.9|||||TWO_SIDED|95.0|0.3|5.5|||||Treatment difference: subcutaneous minus intravenous; Emergency department plus hospital stay|||5.5|0.3|
72518750|NCT00010803|144567330|NON_INFERIORITY_OR_EQUIVALENCE|Previously Provided|Hazard Ratio (HR)|0.84||||0.32|TWO_SIDED|95.0|0.61|1.18|||Log Rank|||Incident Angina||1.18|0.61|0.32
72518751|NCT00010803|144567330|NON_INFERIORITY_OR_EQUIVALENCE|Previously provided|Hazard Ratio (HR)|0.94||||0.66|TWO_SIDED|95.0|0.72|1.23|||Log Rank|||Incident CHD||1.23|0.72|0.66
72518752|NCT00010803|144567330|NON_INFERIORITY_OR_EQUIVALENCE|Previously Provided|Hazard Ratio (HR)|0.91||||0.48|TWO_SIDED|95.0|0.71|1.18|||Log Rank|||Incident CHF||1.18|0.71|0.48
72518753|NCT00010803|144567330|NON_INFERIORITY_OR_EQUIVALENCE|Previously provided|Hazard Ratio (HR)|0.87||||0.25|TWO_SIDED|95.0|0.52|1.45|||Log Rank|||Incident Stroke||1.45|0.52|0.25
72518754|NCT00010803|144567330|NON_INFERIORITY_OR_EQUIVALENCE|Previously provided|Hazard Ratio (HR)|0.87||||0.59|TWO_SIDED|95.0|0.52|1.45|||Log Rank|||Incident TIA||1.45|0.52|0.59
72518755|NCT00010803|144567330|NON_INFERIORITY_OR_EQUIVALENCE|Previously provided|Cox Proportional Hazard|1.12||||0.42|TWO_SIDED|95.0|0.84|1.5|||Log Rank|||Incident CVD||1.50|0.84|0.42
72518756|NCT00010803|144567330|NON_INFERIORITY_OR_EQUIVALENCE|Previously provided|Hazard Ratio (HR)|1.0||||0.98|TWO_SIDED|95.0|0.8|1.25|||Log Rank|||Total CHD and CVD combined||1.25|0.80|0.98
72518757|NCT00010803|144567331|SUPERIORITY_OR_OTHER||Treatment X Time interaction|-0.002||||0.65|TWO_SIDED|95.0|-0.009|0.005|||Mixed Models Analysis|||Linear mixed models comparing rates of change in global cognition scores (z-scores) by treatment group||0.005|-0.009|.65
72518758|NCT01019252|144567332|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.24|||<|0.0001|TWO_SIDED|95.0|3.28|7.21|||Mixed Models Analysis|A longitudinal general linear mixed effects model was used.||||7.21|3.28|<.0001
72518759|NCT01019252|144567333|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.17|||<|0.0001|TWO_SIDED|95.0|0.94|1.39|||Mixed Models Analysis|A longitudinal general linear mixed effects model was used.||||1.39|.94|<.0001
72518760|NCT01019252|144567334|SUPERIORITY||Mean Difference (Net)|10.93|||<|0.0001|TWO_SIDED|95.0|8.93|12.93|||Mixed Models Analysis|A longitudinal general linear mixed effects model was used.||||12.93|8.93|<.0001
72518761|NCT00150345|144567363|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.493||||0.258|TWO_SIDED|95.0|0.129|1.755|||Regression, Logistic||Odds ratio computed from the logistic regression (logit model) including terms for treatment arm, concomitant fluconazole, and positive PCR before randomization. Event IFI=yes is modeled.|Hypothesis: H0: rv - rp = 0 vs H1: rv - rp does not equal 0, where ri is rate of IFI (i=v for voriconazole group, i=p for deferred voriconazole group). Logit model (including important covariates) used. The adjusted odds ratio and 95 percent (%) confidence interval (CI) for adjusted odds ratio calculated. If 95% CI around odds ratio does not contain a value of 1, then the null hypothesis of equal rates of IFI between immediate voriconazole and deferred voriconazole to be rejected.||1.755|0.129|0.258
72518762|NCT00150345|144567364|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.822||||0.596|TWO_SIDED|95.0|0.398|1.696|||Regression, Logistic||Odds ratio computed from the logistic regression (logit model) including terms for treatment arm, concomitant fluconazole, and positive PCR before randomization. Event defervescence=yes is modeled.|||1.696|0.398|0.596
72569602|NCT02944383|144669975|SUPERIORITY|||||||0.8483||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 6||||0.8483
72518763|NCT00150345|144567365|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.936||||0.864|TWO_SIDED|95.0|0.441|1.988|||Regression, Logistic||Odds ratio computed from the logistic regression (logit model) including terms for treatment arm, concomitant fluconazole, and positive PCR before randomization. Event defervescence=yes is modeled.|||1.988|0.441|0.864
72518764|NCT00150345|144567366|SUPERIORITY_OR_OTHER|||||||0.955|TWO_SIDED||||||Log Rank|||||||0.955
72518765|NCT00150345|144567368|SUPERIORITY_OR_OTHER||Difference in % participants that died|5.85|||||TWO_SIDED|95.0|-5.08|16.78|||||Approximate 2-sided confidence interval (CI).|Difference in proportions expressed as a percent: immediate voriconazole versus (vs) deferred voriconazole treatment||16.78|-5.08|
72518766|NCT00150345|144567369|SUPERIORITY_OR_OTHER|||||||0.19|TWO_SIDED||||||Log Rank|||||||0.190
72518767|NCT00150345|144567370|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-22.031|STANDARD_ERROR_OF_MEAN|10.888||0.049|TWO_SIDED|95.0|-44.004|-0.059||SAS PROC REG with SELECTION=STEPWISE option of SLENTRY=0.05 and SLSTAY=0.10 utilized. Stepwise option combined forward stepping (with a 0.05 level to enter) with elimination of variables already in model that do not stay significant at 0.10 level.|Regression, Linear|Variables: association with age, c-reactive protein, and time to continuous defervescence not significant at 0.05 level; not included in final model||Continuous defervescence achieved=Yes||-0.059|-44.004|0.049
72569603|NCT02944383|144669975|SUPERIORITY|||||||0.0008||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.0008
72569604|NCT02944383|144669975|SUPERIORITY|||||||0.0938||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.0938
72569605|NCT02944383|144669975|SUPERIORITY|||||||0.3201||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.3201
72518768|NCT00150345|144567390|SUPERIORITY_OR_OTHER||Difference in percentages|2.51|||||TWO_SIDED|95.0|-14.96|19.97||||||Difference in proportions expressed as a percent: immediate voriconazole vs deferred voriconazole treatment||19.97|-14.96|
72518769|NCT01457924|144567397|SUPERIORITY_OR_OTHER||Ratio|0.35|||<|0.001|TWO_SIDED|95.0|0.221|0.548|||Non-Linear Emax Model|||Note: There is a discrepancy in the number of par. in ITT populations at Wk 24 and Wk 48: 228 and 229 respectively. This resulted from a data issue: one par was incorrectly excluded from ITT pop. at Wk 24, but correctly included in Wk 48. This error affects all source tables, analyses relating to ITT and per protocol populations, primary endpoint and secondary MRI endpoints reported at Wk 24. This discrepancy affects all statistical analyses, but not summary statistics.||0.548|0.221|<0.001
72518770|NCT01457924|144567397|SUPERIORITY_OR_OTHER||Ratio|0.35|||<|0.001|TWO_SIDED|95.0|0.221|0.548|||Non-Linear Emax Model|||||0.548|0.221|<0.001
72518771|NCT01457924|144567397|SUPERIORITY_OR_OTHER||Ratio|0.35|||<|0.001|TWO_SIDED|95.0|0.221|0.548|||Non-Linear Emax Model|||||0.548|0.221|<0.001
72518772|NCT01457924|144567397|SUPERIORITY_OR_OTHER||Ratio|0.35|||<|0.001|TWO_SIDED|95.0|0.221|0.548|||Non-Linear Emax Model|||||0.548|0.221|<0.001
72518773|NCT01457924|144567398|SUPERIORITY_OR_OTHER||Ratio|0.38||||0.003|TWO_SIDED|95.0|0.2|0.72|||Generalized Linear Model|||||0.72|0.20|0.003
72518774|NCT01457924|144567398|SUPERIORITY_OR_OTHER||Ratio|0.38||||0.003|TWO_SIDED|95.0|0.2|0.72|||Generalized Linear Model|||||0.72|0.20|0.003
72518775|NCT01457924|144567398|SUPERIORITY_OR_OTHER||Ratio|0.35||||0.001|TWO_SIDED|95.0|0.19|0.65|||Generalized Linear Model|||||0.65|0.19|0.001
72569606|NCT02944383|144669975|SUPERIORITY|||||||0.901||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.9010
72518776|NCT01457924|144567398|SUPERIORITY_OR_OTHER||Ratio|0.23|||<|0.001|TWO_SIDED|95.0|0.13|0.39|||Generalized Linear Model|||||0.39|0.13|<0.001
72518777|NCT01457924|144567401|SUPERIORITY_OR_OTHER||Ratio|0.31|||<|0.001|TWO_SIDED|95.0|0.16|0.6|||Generalized Linear Model|||||0.60|0.16|<0.001
72518778|NCT01457924|144567401|SUPERIORITY_OR_OTHER||Ratio|0.56||||0.075|TWO_SIDED|95.0|0.29|1.06|||Generalized Linear Model|||||1.06|0.29|0.075
72518779|NCT01457924|144567401|SUPERIORITY_OR_OTHER||Ratio|0.51||||0.035|TWO_SIDED|95.0|0.27|0.95|||Generalized Linear Model|||||0.95|0.27|0.035
72518780|NCT01457924|144567401|SUPERIORITY_OR_OTHER||Ratio|0.32|||<|0.001|TWO_SIDED|95.0|0.19|0.55|||Generalized Linear Model|||||0.55|0.19|<0.001
72518781|NCT01457924|144567402|SUPERIORITY_OR_OTHER||Ratio|0.22||||0.026|TWO_SIDED|95.0|0.06|0.84|||Generalized Linear Model|||||0.84|0.06|0.026
72518782|NCT01457924|144567402|SUPERIORITY_OR_OTHER||Ratio|0.49||||0.296|TWO_SIDED|95.0|0.13|1.86|||Generalized Linear Model|||||1.86|0.13|0.296
72518783|NCT01457924|144567402|SUPERIORITY_OR_OTHER||Ratio|0.5||||0.285|TWO_SIDED|95.0|0.14|1.78|||Generalized Linear Model|||||1.78|0.14|0.285
72518784|NCT01457924|144567402|SUPERIORITY_OR_OTHER||Ratio|0.25||||0.009|TWO_SIDED|95.0|0.09|0.71|||Non-Linear Emax Model|||||0.71|0.09|0.009
72518785|NCT01457924|144567403|SUPERIORITY_OR_OTHER||Ratio|0.18||||0.004|TWO_SIDED|95.0|0.05|0.58|||Generalized Linear Model|||||0.58|0.05|0.004
72518786|NCT01457924|144567403|SUPERIORITY_OR_OTHER||Ratio|0.5||||0.248|TWO_SIDED|95.0|0.15|1.63|||Generalized Linear Model|||||1.63|0.15|0.248
72518787|NCT01457924|144567403|SUPERIORITY_OR_OTHER||Ratio|0.46||||0.181|TWO_SIDED|95.0|0.15|1.43|||Generalized Linear Model|||||1.43|0.15|0.181
72518788|NCT01457924|144567403|SUPERIORITY_OR_OTHER||Ratio|0.24||||0.003|TWO_SIDED|95.0|0.1|0.62|||Generalized Linear Model|||||0.62|0.10|0.003
72518789|NCT01457924|144567404|SUPERIORITY_OR_OTHER||Ratio|0.29|||<|0.001|TWO_SIDED|95.0|0.15|0.58|||Generalized Linear Model|||||0.58|0.15|<0.001
72624868|NCT00928668|144779214|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.443|STANDARD_ERROR_OF_MEAN|0.248|<|0.0001|TWO_SIDED|95.0|1.952|2.935|||Mixed Models Analysis|Adjusted using an analysis of variance with terms for centre, patients within centre, treatment and period (all as fixed effects)|Olo 10 mcg minus Placebo|||2.935|1.952|<0.0001
72518790|NCT01457924|144567404|SUPERIORITY_OR_OTHER||Ratio|0.34||||0.002|TWO_SIDED|95.0|0.17|0.68|||Generalized Linear Model|||||0.68|0.17|0.002
72569607|NCT02944383|144669975|SUPERIORITY||Median Difference (Net)|-19.31||||0.0156|TWO_SIDED|95.0|-39.06|-1.49||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|EOS (average of week 10 and 12)||-1.49|-39.06|0.0156
72518791|NCT01457924|144567404|SUPERIORITY_OR_OTHER||Ratio|0.4||||0.006|TWO_SIDED|95.0|0.21|0.77|||Generalized Linear Model|||||0.77|0.21|0.006
72518792|NCT01457924|144567404|SUPERIORITY_OR_OTHER||Ratio|0.19|||<|0.001|TWO_SIDED|95.0|0.11|0.35|||Generalized Linear Model|||||0.35|0.11|<0.001
72518793|NCT02781454|144567436|SUPERIORITY||linear contrast active vs placebo|-5.558||||0.039|TWO_SIDED|95.0|-10.8|-0.315|||Mixed Models Analysis|||Comparison of active (300 and 600 mg) vs placebo for change from baseline to week 4||-0.315|-10.80|0.039
72518794|NCT02781454|144567437|SUPERIORITY||linear contrast active vs placebo|0.792||||0.332|TWO_SIDED|95.0|0.484|1.296||linear contrast active vs placebo|Mixed Models Analysis|||Comparison of active (300 and 600 mg) vs placebo ratio of week 4 to week 0||1.296|0.484|0.332
72518795|NCT02781454|144567438|SUPERIORITY||linear contrast active vs placebo|0.411||||0.013|TWO_SIDED|95.0|0.208|0.81|||Mixed Models Analysis|||Comparison of active (300 and 600 mg) vs placebo ratio of week 4 to week 0||0.810|0.208|0.013
72518796|NCT02781454|144567439|SUPERIORITY||linear contrast active vs placebo|0.343||||0.986|TWO_SIDED|95.0|-41.36|42.042|||Mixed Models Analysis|||Comparison of active (300 and 600 mg) vs placebo for change from baseline to week 4||42.042|-41.36|0.986
72518797|NCT02781454|144567440|SUPERIORITY||linear contrast active vs placebo|0.994||||0.915|TWO_SIDED|95.0|0.876|1.126|||Mixed Models Analysis|||Comparison of active (300 and 600 mg) vs placebo ratio of week 4 to week 0||1.126|0.876|0.915
72518798|NCT02781454|144567441|SUPERIORITY||linear contrast active vs placebo|1.089||||0.694|TWO_SIDED|95.0|-4.609|6.786|||Mixed Models Analysis|||Comparison of active (300 and 600 mg) vs placebo for change from baseline to week 4||6.786|-4.609|0.694
72518799|NCT02781454|144567442|SUPERIORITY||linear contrast active vs placebo|0.242||||0.969|TWO_SIDED|95.0|-12.64|13.126|||Mixed Models Analysis|||Comparison of active (300 and 600 mg) vs placebo for change from baseline to week 4||13.126|-12.64|0.969
72518800|NCT02781454|144567443|SUPERIORITY||linear contrast active vs placebo|2.597||||0.323|TWO_SIDED|95.0|-2.772|7.966|||Mixed Models Analysis|||Comparison of active (300 and 600 mg) vs placebo for change from baseline to week 4||7.966|-2.772|0.323
72518801|NCT02781454|144567444|SUPERIORITY||linear contrast active vs placebo|-2.017||||0.273|TWO_SIDED|95.0|-5.767|1.733|||Mixed Models Analysis|||Comparison of active (300 and 600 mg) vs placebo for change from baseline to week 4||1.733|-5.767|0.273
72518802|NCT02781454|144567445|SUPERIORITY||linear contrast active vs placebo|0.708||||0.713|TWO_SIDED|95.0|0.111|4.535|||Mixed Models Analysis|||Comparison of active (300 and 600 mg) vs placebo||4.535|0.111|0.713
72518803|NCT02781454|144567447|SUPERIORITY||linear contrast active vs placebo|-0.399||||0.601|TWO_SIDED|95.0|-1.966|1.169|||Mixed Models Analysis|||Comparison of active (300 and 600 mg) vs placebo for change from baseline to week 4||1.169|-1.966|0.601
72518804|NCT02781454|144567448|SUPERIORITY||linear contrast active vs placebo|-2.734||||0.285|TWO_SIDED|95.0|-7.938|2.471|||Mixed Models Analysis|||Comparison of active (300 and 600 mg) vs placebo for change from baseline to week 4||2.471|-7.938|0.285
72518805|NCT02372097|144567465|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Two tablets of SYR-472 25 mg and 1 tablet of SYR-472 50 mg were considered bioequivalent if 90% CI of the mean differences of natural log-transformed AUC(0-168) of SYR-472Z was within the range of ln(0.80) to ln(1.25) or within the range of ln(0.9) to ln(1.11) and the results of dissolution test satisfied the requirement.|Least square (LS) mean difference|-0.017|||||TWO_SIDED|90.0|-0.0344|0.0004||||||The 2-sided 90% confidence interval for the difference between the products (2 tablets of SYR-472 25 mg, 1 tablet of SYR-472 50 mg) was determined from the ANOVA model with the natural logarithms of the AUC(0-168) as a dependent variable, and product, group and period as fixed effects.||0.0004|-0.0344|
72518806|NCT02372097|144567466|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Two tablets of SYR-472 25 mg and 1 tablet of SYR-472 50 mg were considered bioequivalent if 90% CI of the mean differences of natural log-transformed Cmax of SYR-472Z was within the range of ln(0.80) to ln(1.25) or within the range of ln(0.9) to ln(1.11) and the results of dissolution test satisfied the requirement.|LS mean difference|-0.1292|||||TWO_SIDED|90.0|-0.2177|-0.0406||||||The 2-sided 90% confidence interval for the difference between the products (2 tablets of SYR-472 25 mg, 1 tablet of SYR-472 50 mg) was determined from the ANOVA model with the natural logarithms of the Cmax as a dependent variable, and product, group and period as fixed effects.||-0.0406|-0.2177|
72518807|NCT02372097|144567467|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.021||||||90.0|-0.0362|-0.0058||||||The 2-sided 90% confidence interval for the difference between the products (2 tablets of SYR-472 25 mg, 1 tablet of SYR-472 50 mg) was determined from the ANOVA model with the natural logarithms of the AUC(0-inf) as a dependent variable, and product, group and period as fixed effects.||-0.0058|-0.0362|
72518808|NCT02372097|144567468|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.375|||||TWO_SIDED|90.0|-0.1452|0.8952||||||The 2-sided 90% confidence interval for the difference between the products (2 tablets of SYR-472 25 mg, 1 tablet of SYR-472 50 mg) was determined from the ANOVA model with Tmax as a dependent variable, and product, group and period as fixed effects.||0.8952|-0.1452|
72518809|NCT02372097|144567469|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.0168|||||TWO_SIDED|90.0|-0.0504|0.0169||||||The 2-sided 90% confidence interval for the difference between the products (2 tablets of SYR-472 25 mg, 1 tablet of SYR-472 50 mg) was determined from the ANOVA model with the natural logarithms of the MRT as a dependent variable, and product, group and period as fixed effects.||0.0169|-0.0504|
72518810|NCT02372097|144567470|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.1099|||||TWO_SIDED|90.0|0.0235|0.1963||||||The 2-sided 90% confidence interval for the difference between the products (2 tablets of SYR-472 25 mg, 1 tablet of SYR-472 50 mg) was determined from the ANOVA model with the natural logarithms of the λz as a dependent variable, and product, group and period as fixed effects.||0.1963|0.0235|
72518811|NCT03219567|144567485|OTHER|||||||0.35|||||||t-test, 2 sided|||OCT compared to MRI||||0.35
72518812|NCT01654523|144567521|SUPERIORITY_OR_OTHER||Mean change in the single arm trial|6.695|STANDARD_DEVIATION|5.505|<|0.05|TWO_SIDED|95.0|4.041|9.348|||Paired t-test|||||9.348|4.041|<0.05
72518813|NCT01313208|144567522|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.83||||0.055|TWO_SIDED|95.0|0.99|3.41|||Mantel Haenszel|P-value from Mantel-Haenszel test stratified by participant's baseline methotrexate use (yes or no).|Etanercept/Placebo|||3.41|0.99|0.055
72518814|NCT03258632|144567564|SUPERIORITY||Odds Ratio (OR)|1.17|||<|0.05|TWO_SIDED|95.0|0.73|1.9|||Mixed Models Analysis|||||1.90|0.73|<.05
72518815|NCT01957787|144567566|OTHER|||||||0.41||||||Estimates of the log odds and Wald standard error from a random effects logistic regression model were combined across imputed datasets for reference.|Random effects logistic regression model|||The null hypothesis was tested comparing the lower bound of the Wald 97.5% 1-sided confidence interval for the estimated rate of local tumor control to the performance goal of 84.0%. If the lower bound was greater than 84.0%, the null hypothesis was rejected and the endpoint was considered met.||||0.410
72518816|NCT04046341|144567587|OTHER|||||||0.008||||||A priori statistical significance threshold = p\<.05|McNemar|||||||.008
72518817|NCT04046341|144567588|SUPERIORITY|||||||0.014||||||A priori statistical significance threshold = p\<.05|t-test, 2 sided|||||||.014
72518818|NCT04046341|144567589|SUPERIORITY|||||||0.013||||||A priori statistical significance threshold = p\<.05|t-test, 2 sided|||||||.013
72518819|NCT04046341|144567590|SUPERIORITY|||||||0.001||||||A priori statistical significance threshold = p\<.05|t-test, 2 sided|||||||.001
72518820|NCT04046341|144567591|SUPERIORITY|||||||0.209||||||A priori statistical significance threshold = p\<.05|t-test, 2 sided|||||||.209
72405538|NCT00773175|144319220|NON_INFERIORITY|Subcutaneous administration would not be deemed as inferior if the volume infused subcutaneous is ≥85% of the volume infused intravenously.|Mean Difference (Final Values)|2.2|||||TWO_SIDED|95.0|-0.2|4.7|||||Treatment difference: subcutaneous minus intravenous; Emergency department stay only|||4.7|-0.2|
72518821|NCT00435994|144567603|SUPERIORITY_OR_OTHER|||||||0.002|||||||ANOVA|||||||0.0020
72518822|NCT00435994|144567604|SUPERIORITY_OR_OTHER|||||||0.002|||||||ANOVA|||||||.0020
72518823|NCT03846219|144567620|SUPERIORITY||rate ratio|0.38||||0.0002|TWO_SIDED|95.0|0.22|0.64||A one-sided alpha level of 0.1 was used.|generalized linear model|Estimates were adjusted for baseline volume of T2 lesions, MRI field strength (1.5 or 3.0 Tesla), and baseline number of Gd+ lesions (0, ≥1).|Rate ratio of 45 mg IMU-838 / placebo|H0: cumulative number of CUA MRI lesions up to Week 24 with 45 mg IMU-838 equal to or higher than that with placebo. A generalized linear model with a negative binomial distribution and logarithmic link function was used. Log transformation of time from 1st IMP dose to date of last MRI assessment was used as offset term. 51 patients per group were necessary to have 80% power to detect a difference of 3.5 in mean event rate with a significance level 0.1, 1-sided.||0.64|0.22|0.0002
72569608|NCT02944383|144669975|SUPERIORITY||Median Difference (Net)|-5.98||||0.3456|TWO_SIDED|95.0|-28.51|17.26||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|EOS (average of week 10 and 12)||17.26|-28.51|0.3456
72624869|NCT00928668|144779214|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.984|STANDARD_ERROR_OF_MEAN|0.251|<|0.0001|TWO_SIDED|95.0|2.486|3.483|||Mixed Models Analysis|Adjusted using an analysis of variance with terms for centre, patients within centre, treatment and period (all as fixed effects)|Form 20 mcg minus Placebo|||3.483|2.486|<0.0001
72518824|NCT03846219|144567621|SUPERIORITY||Rate ratio|0.3|||<|0.0001|TWO_SIDED|95.0|0.17|0.53||A hierarchical testing procedure with a one-sided alpha level of 0.1 was used.|Generalized linear model|Estimates were adjusted for baseline volume of T2 lesions, MRI field strength (1.5 or 3.0 Tesla), and baseline number of Gd+ lesions (0, ≥1).|Rate ratio of 30 mg IMU-838 / placebo|A generalized linear model with a negative binomial distribution and logarithmic link function was used. Log transformation of time from 1st IMP dose to date of last MRI assessment was used as offset term.||0.53|0.17|<.0001
72518825|NCT05109702|144567677|SUPERIORITY||LS Mean Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.094||0.764|TWO_SIDED|95.0|-0.214|0.157|||MMRM|||The Least Square (LS) means, LS mean difference, Standard Errors (SEs), two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the Mixed model repeated measures (MMRM) model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.157|-0.214|0.764
72518826|NCT05109702|144567678|SUPERIORITY||LS Mean Difference|4.34|STANDARD_ERROR_OF_MEAN|2.969||0.144|TWO_SIDED|95.0|-1.483|10.155|||MMRM|||The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||10.155|-1.483|0.144
72518827|NCT05109702|144567679|SUPERIORITY||LS Mean Difference|0.18|STANDARD_ERROR_OF_MEAN|0.094||0.056|TWO_SIDED|95.0|-0.005|0.363|||MMRM|||Week 1 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.363|-0.005|0.056
72518828|NCT05109702|144567679|SUPERIORITY||LS Mean Difference|0.17|STANDARD_ERROR_OF_MEAN|0.094||0.064|TWO_SIDED|95.0|-0.01|0.359|||MMRM|||Week 2 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.359|-0.010|0.064
72518829|NCT05109702|144567679|SUPERIORITY||LS Mean Difference|0.09|STANDARD_ERROR_OF_MEAN|0.095||0.328|TWO_SIDED|95.0|-0.093|0.279|||MMRM|||Week 4 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.279|-0.093|0.328
72518830|NCT05109702|144567679|SUPERIORITY||LS Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.096||0.837|TWO_SIDED|95.0|-0.208|0.168|||MMRM|||Week 8 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.168|-0.208|0.837
72569609|NCT02944383|144669976|SUPERIORITY|||||||0.3714||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 2||||0.3714
72405539|NCT00773175|144319221|NON_INFERIORITY|Subcutaneous administration would not be deemed as inferior if the volume infused subcutaneous is ≥85% of the volume infused intravenously.|Mean Difference (Final Values)|-0.4|||||TWO_SIDED|95.0|-2.8|1.9|||||Treatment difference: subcutaneous minus intravenous; Emergency department plus hospital stay|||1.9|-2.8|
72405540|NCT00773175|144319221|NON_INFERIORITY|Subcutaneous administration would not be deemed as inferior if the volume infused subcutaneous is ≥85% of the volume infused intravenously.|Mean Difference (Final Values)|-1.3|||||TWO_SIDED|95.0|-3.4|0.8|||||Treatment difference: subcutaneous minus intravenous; Emergency department stay only|||0.8|-3.4|
72405541|NCT00773175|144319232|SUPERIORITY||Mean Difference (Final Values)|0.2|||||TWO_SIDED|95.0|0.1|0.3|||||Treatment difference = SC minus IV|||0.3|0.1|
72518831|NCT05109702|144567680|SUPERIORITY||LS Mean Difference|0.03|STANDARD_ERROR_OF_MEAN|0.079||0.686|TWO_SIDED|95.0|-0.123|0.187|||MMRM|||Week 1 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.187|-0.123|0.686
72518832|NCT05109702|144567680|SUPERIORITY||LS Mean Difference|0.03|STANDARD_ERROR_OF_MEAN|0.079||0.68|TWO_SIDED|95.0|-0.123|0.188|||MMRM|||Week 2 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.188|-0.123|0.680
72518833|NCT05109702|144567680|SUPERIORITY||LS Mean Difference|0.05|STANDARD_ERROR_OF_MEAN|0.08||0.529|TWO_SIDED|95.0|-0.107|0.207|||MMRM|||Week 4 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.207|-0.107|0.529
72518834|NCT05109702|144567680|SUPERIORITY||LS Mean Difference|0.03|STANDARD_ERROR_OF_MEAN|0.081||0.745|TWO_SIDED|95.0|-0.132|0.185|||MMRM|||Week 8 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.185|-0.132|0.745
72518835|NCT05109702|144567681|SUPERIORITY||LS Mean Difference|0.03|STANDARD_ERROR_OF_MEAN|0.085||0.765|TWO_SIDED|95.0|-0.141|0.192|||MMRM|||Week 1 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.192|-0.141|0.765
72569610|NCT02944383|144669976|SUPERIORITY|||||||0.4415||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 2||||0.4415
72569611|NCT02944383|144669976|SUPERIORITY|||||||0.7902||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 6||||0.7902
72569612|NCT02944383|144669976|SUPERIORITY|||||||0.6999||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 6||||0.6999
72569613|NCT02944383|144669976|SUPERIORITY|||||||0.0015||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.0015
72569614|NCT02944383|144669976|SUPERIORITY|||||||0.0796||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.0796
72569615|NCT02944383|144669976|SUPERIORITY|||||||0.4225||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.4225
72569616|NCT02944383|144669976|SUPERIORITY|||||||0.7687||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.7687
72569617|NCT02944383|144669976|SUPERIORITY|||||||0.0437||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||EOS (average of week 10 and 12)||||0.0437
72569618|NCT02944383|144669976|SUPERIORITY|||||||0.2735||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||EOS (average of week 10 and 12)||||0.2735
72569619|NCT02944383|144669977|SUPERIORITY|||||||0.1042||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 2||||0.1042
72569620|NCT02944383|144669977|SUPERIORITY|||||||0.6204||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 2||||0.6204
72569621|NCT02944383|144669977|SUPERIORITY|||||||0.8659||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 6||||0.8659
72569622|NCT02944383|144669977|SUPERIORITY|||||||0.9658||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 6||||0.9658
72518836|NCT05109702|144567681|SUPERIORITY||LS Mean Difference|0.16|STANDARD_ERROR_OF_MEAN|0.085||0.053|TWO_SIDED|95.0|-0.002|0.331|||MMRM|||Week 2 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.331|-0.002|0.053
72518837|NCT05109702|144567681|SUPERIORITY||LS Mean Difference|0.05|STANDARD_ERROR_OF_MEAN|0.086||0.552|TWO_SIDED|95.0|-0.117|0.219|||MMRM|||Week 4 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.219|-0.117|0.552
72518838|NCT05109702|144567681|SUPERIORITY||LS Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.087||0.593|TWO_SIDED|95.0|-0.216|0.124|||MMRM|||Week 8 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.124|-0.216|0.593
72518839|NCT05109702|144567682|SUPERIORITY||LS Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.087||0.884|TWO_SIDED|95.0|-0.183|0.158|||MMRM|||Week 1 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.158|-0.183|0.884
72518840|NCT05109702|144567682|SUPERIORITY||LS Mean Difference|0.06|STANDARD_ERROR_OF_MEAN|0.087||0.474|TWO_SIDED|95.0|-0.109|0.233|||MMRM|||Week 2 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.233|-0.109|0.474
72518841|NCT05109702|144567682|SUPERIORITY||LS Mean Difference|0.11|STANDARD_ERROR_OF_MEAN|0.088||0.202|TWO_SIDED|95.0|-0.06|0.285|||MMRM|||Week 4 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.285|-0.060|0.202
72518842|NCT05109702|144567682|SUPERIORITY||LS Mean Difference|0.22|STANDARD_ERROR_OF_MEAN|0.089||0.013|TWO_SIDED|95.0|0.047|0.396|||MMRM|||Week 8 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.396|0.047|0.013
72518843|NCT05109702|144567683|OTHER||LS Mean Difference|0.05|STANDARD_ERROR_OF_MEAN|0.09||0.604|TWO_SIDED|95.0|-0.131|0.224|||MMRM|||Week 1 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.224|-0.131|0.604
72518844|NCT05109702|144567683|SUPERIORITY||LS Mean Difference|0.06|STANDARD_ERROR_OF_MEAN|0.091||0.519|TWO_SIDED|95.0|-0.119|0.236|||MMRM|||Week 2 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.236|-0.119|0.519
72518845|NCT05109702|144567683|SUPERIORITY||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.092||0.299|TWO_SIDED|95.0|-0.085|0.275|||MMRM|||Week 4 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.275|-0.085|0.299
72518846|NCT05109702|144567683|SUPERIORITY||LS Mean Difference|0.14|STANDARD_ERROR_OF_MEAN|0.093||0.124|TWO_SIDED|95.0|-0.039|0.324|||MMRM|||Week 8 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.324|-0.039|0.124
72518847|NCT05109702|144567684|SUPERIORITY||LS Mean Difference|0.23|STANDARD_ERROR_OF_MEAN|0.215||0.293|TWO_SIDED|95.0|-0.196|0.647|||MMRM|||Week 1 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.647|-0.196|0.293
72518848|NCT05109702|144567684|SUPERIORITY||LS Mean Difference|0.36|STANDARD_ERROR_OF_MEAN|0.215||0.094|TWO_SIDED|95.0|-0.062|0.783|||MMRM|||Week 2 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.783|-0.062|0.094
72518849|NCT05109702|144567684|SUPERIORITY||LS Mean Difference|0.18|STANDARD_ERROR_OF_MEAN|0.217||0.404|TWO_SIDED|95.0|-0.245|0.608|||MMRM|||Week 4 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.608|-0.245|0.404
72518850|NCT05109702|144567684|SUPERIORITY||LS Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.22||0.806|TWO_SIDED|95.0|-0.485|0.377|||MMRM|||Week 8 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.377|-0.485|0.806
72518851|NCT05109702|144567685|SUPERIORITY||LS Mean Difference|0.03|STANDARD_ERROR_OF_MEAN|0.157||0.824|TWO_SIDED|95.0|-0.273|0.343|||MMRM|||Week 1 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.343|-0.273|0.824
72518852|NCT05109702|144567685|SUPERIORITY||LS Mean Difference|0.12|STANDARD_ERROR_OF_MEAN|0.157||0.437|TWO_SIDED|95.0|-0.186|0.431|||MMRM|||Week 2 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.431|-0.186|0.437
72518853|NCT05109702|144567685|SUPERIORITY||LS Mean Difference|0.21|STANDARD_ERROR_OF_MEAN|0.159||0.193|TWO_SIDED|95.0|-0.105|0.519|||MMRM|||Week 4 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.519|-0.105|0.193
72518854|NCT05109702|144567685|SUPERIORITY||LS Mean Difference|0.36|STANDARD_ERROR_OF_MEAN|0.161||0.024|TWO_SIDED|95.0|0.048|0.679|||MMRM|||Week 8 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.679|0.048|0.024
72518855|NCT05109702|144567686|SUPERIORITY||LS Mean Difference|0.26|STANDARD_ERROR_OF_MEAN|0.329||0.43|TWO_SIDED|95.0|-0.386|0.907|||MMRM|||Week 1 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.907|-0.386|0.430
72518856|NCT05109702|144567686|SUPERIORITY||LS Mean Difference|0.48|STANDARD_ERROR_OF_MEAN|0.33||0.143|TWO_SIDED|95.0|-0.164|1.132|||MMRM|||Week 2 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||1.132|-0.164|0.143
72518857|NCT05109702|144567686|SUPERIORITY||LS Mean Difference|0.39|STANDARD_ERROR_OF_MEAN|0.333||0.245|TWO_SIDED|95.0|-0.267|1.042|||MMRM|||Week 4 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||1.042|-0.267|0.245
72518858|NCT05109702|144567686|SUPERIORITY||LS Mean Difference|0.31|STANDARD_ERROR_OF_MEAN|0.337||0.359|TWO_SIDED|95.0|-0.352|0.97|||MMRM|||Week 8 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.970|-0.352|0.359
72518859|NCT05109702|144567687|SUPERIORITY||LS Mean Difference|0.16|STANDARD_ERROR_OF_MEAN|0.067||0.016|TWO_SIDED|95.0|0.03|0.292|||MMRM|||Week 1 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.292|0.030|0.016
72518860|NCT05109702|144567687|SUPERIORITY||LS Mean Difference|0.11|STANDARD_ERROR_OF_MEAN|0.067||0.099|TWO_SIDED|95.0|-0.021|0.242|||MMRM|||Week 2 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.242|-0.021|0.099
72624870|NCT00928668|144779215|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.139|STANDARD_ERROR_OF_MEAN|0.249|<|0.0001|TWO_SIDED|95.0|1.645|2.633|||Mixed Models Analysis|Adjusted using an analysis of variance with terms for centre, patients within centre, treatment and period (all as fixed effects)|Olo 2 mcg minus Placebo|||2.633|1.645|<0.0001
72624871|NCT00928668|144779215|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.636|STANDARD_ERROR_OF_MEAN|0.252|<|0.0001|TWO_SIDED|95.0|2.135|3.136|||Mixed Models Analysis|Adjusted using an analysis of variance with terms for centre, patients within centre, treatment and period (all as fixed effects)|Olo 5 mcg minus Placebo|||3.136|2.135|<0.0001
72518861|NCT05109702|144567687|SUPERIORITY||LS Mean Difference|0.05|STANDARD_ERROR_OF_MEAN|0.068||0.493|TWO_SIDED|95.0|-0.086|0.179|||MMRM|||Week 4 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.179|-0.086|0.493
72518862|NCT05109702|144567687|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.068||0.987|TWO_SIDED|95.0|-0.133|0.135|||MMRM|||Week 8 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.135|-0.133|0.987
72518863|NCT05109702|144567688|SUPERIORITY||LS Mean Difference|0.03|STANDARD_ERROR_OF_MEAN|0.072||0.655|TWO_SIDED|95.0|-0.109|0.173|||MMRM|||Week 1 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.173|-0.109|0.655
72518864|NCT05109702|144567688|SUPERIORITY||LS Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.072||0.826|TWO_SIDED|95.0|-0.157|0.125|||MMRM|||Week 2 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.125|-0.157|0.826
72518865|NCT05109702|144567688|SUPERIORITY||LS Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.073||0.861|TWO_SIDED|95.0|-0.155|0.13|||MMRM|||Week 4 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.130|-0.155|0.861
72518866|NCT05109702|144567688|SUPERIORITY||LS Mean Difference|0.04|STANDARD_ERROR_OF_MEAN|0.073||0.556|TWO_SIDED|95.0|-0.101|0.187|||MMRM|||Week 8 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.187|-0.101|0.556
72518867|NCT05109702|144567689|SUPERIORITY||LS Mean Difference|0.06|STANDARD_ERROR_OF_MEAN|0.087||0.527|TWO_SIDED|95.0|-0.116|0.226|||MMRM|||Week 1 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.226|-0.116|0.527
72518868|NCT05109702|144567689|SUPERIORITY||LS Mean Difference|0.25|STANDARD_ERROR_OF_MEAN|0.087||0.005|TWO_SIDED|95.0|0.077|0.418|||MMRM|||Week 2 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.418|0.077|0.005
72518869|NCT05109702|144567689|SUPERIORITY||LS Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.088||0.92|TWO_SIDED|95.0|-0.164|0.181|||MMRM|||Wek 4 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors||0.181|-0.164|0.920
72518870|NCT05109702|144567689|SUPERIORITY||LS Mean Difference|0.09|STANDARD_ERROR_OF_MEAN|0.089||0.286|TWO_SIDED|95.0|-0.08|0.269|||MMRM|||Week 8 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.269|-0.080|0.286
72518871|NCT05109702|144567690|SUPERIORITY||LS Mean Difference|0.18|STANDARD_ERROR_OF_MEAN|0.098||0.071|TWO_SIDED|95.0|-0.015|0.369|||MMRM|||Week 1 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.369|-0.015|0.071
72518872|NCT05109702|144567690|SUPERIORITY||LS Mean Difference|0.09|STANDARD_ERROR_OF_MEAN|0.098||0.384|TWO_SIDED|95.0|-0.107|0.278|||MMRM|||Week 2 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.278|-0.107|0.384
72569623|NCT02944383|144669977|SUPERIORITY|||||||0.8238||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.8238
72569624|NCT02944383|144669977|SUPERIORITY|||||||0.4874||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.4874
72518873|NCT05109702|144567690|SUPERIORITY||LS Mean Difference|0.09|STANDARD_ERROR_OF_MEAN|0.099||0.391|TWO_SIDED|95.0|-0.109|0.28|||MMRM|||Week 4 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.280|-0.109|0.391
72518874|NCT05109702|144567690|SUPERIORITY||LS Mean Difference|0.03|STANDARD_ERROR_OF_MEAN|0.1||0.802|TWO_SIDED|95.0|-0.171|0.222|||MMRM|||Week 8 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.222|-0.171|0.802
72518875|NCT05109702|144567691|SUPERIORITY||LS Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.098||0.884|TWO_SIDED|95.0|-0.206|0.178|||MMRM|||Week 1 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.178|-0.206|0.884
72518876|NCT05109702|144567691|SUPERIORITY||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.098||0.303|TWO_SIDED|95.0|-0.091|0.293|||MMRM|||Week 2 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.293|-0.091|0.303
72518877|NCT05109702|144567691|SUPERIORITY||LS Mean Difference|0.06|STANDARD_ERROR_OF_MEAN|0.099||0.554|TWO_SIDED|95.0|-0.135|0.253|||MMRM|||Week 4 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.253|-0.135|0.554
72518878|NCT05109702|144567691|SUPERIORITY||LS Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|0.1||0.051|TWO_SIDED|95.0|-0.001|0.391|||MMRM|||Week 8 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.391|-0.001|0.051
72518879|NCT05109702|144567692|SUPERIORITY||LS Mean Difference|0.26|STANDARD_ERROR_OF_MEAN|0.17||0.131|TWO_SIDED|95.0|-0.077|0.591|||MMRM|||Week 1 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.591|-0.077|0.131
72518880|NCT05109702|144567692|SUPERIORITY||LS Mean Difference|0.35|STANDARD_ERROR_OF_MEAN|0.171||0.04|TWO_SIDED|95.0|0.016|0.685|||MMRM|||Week 2 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.685|0.016|0.040
72518881|NCT05109702|144567692|SUPERIORITY||LS Mean Difference|0.05|STANDARD_ERROR_OF_MEAN|0.172||0.767|TWO_SIDED|95.0|-0.287|0.389|||MMRM|||Week 4 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.389|-0.287|0.767
72518882|NCT05109702|144567692|SUPERIORITY||LS Mean Difference|0.14|STANDARD_ERROR_OF_MEAN|0.174||0.41|TWO_SIDED|95.0|-0.198|0.485|||MMRM|||Week 8 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.485|-0.198|0.410
72518883|NCT05109702|144567693|SUPERIORITY||LS Mean Difference|0.17|STANDARD_ERROR_OF_MEAN|0.17||0.324|TWO_SIDED|95.0|-0.166|0.501|||MMRM|||Week 1 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.501|-0.166|0.324
72518884|NCT05109702|144567693|SUPERIORITY||LS Mean Difference|0.19|STANDARD_ERROR_OF_MEAN|0.17||0.262|TWO_SIDED|95.0|-0.143|0.525|||MMRM|||Week 2 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.525|-0.143|0.262
72569625|NCT02944383|144669977|SUPERIORITY|||||||0.9467||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.9467
72569626|NCT02944383|144669977|SUPERIORITY|||||||0.7467||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.7467
72518885|NCT05109702|144567693|SUPERIORITY||LS Mean Difference|0.15|STANDARD_ERROR_OF_MEAN|0.172||0.391|TWO_SIDED|95.0|-0.19|0.485|||MMRM|||Week 4 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.485|-0.190|0.391
72518886|NCT05109702|144567693|SUPERIORITY||LS Mean Difference|0.23|STANDARD_ERROR_OF_MEAN|0.174||0.192|TWO_SIDED|95.0|-0.114|0.568|||MMRM|||Week 8 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.568|-0.114|0.192
72518887|NCT05109702|144567694|SUPERIORITY||LS Mean Difference|0.43|STANDARD_ERROR_OF_MEAN|0.29||0.14|TWO_SIDED|95.0|-0.141|0.999|||MMRM|||Week 1 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.999|-0.141|0.140
72518888|NCT05109702|144567694|SUPERIORITY||LS Mean Difference|0.55|STANDARD_ERROR_OF_MEAN|0.291||0.061|TWO_SIDED|95.0|-0.025|1.117|||MMRM|||Week 2 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||1.117|-0.025|0.061
72518889|NCT05109702|144567694|SUPERIORITY||LS Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|0.294||0.49|TWO_SIDED|95.0|-0.374|0.78|||MMRM|||Week 4 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.780|-0.374|0.490
72518890|NCT05109702|144567694|SUPERIORITY||LS Mean Difference|0.37|STANDARD_ERROR_OF_MEAN|0.297||0.212|TWO_SIDED|95.0|-0.212|0.953|||MMRM|||Week 8 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.953|-0.212|0.212
72518891|NCT05109702|144567695|SUPERIORITY||LS Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.06||0.784|TWO_SIDED|95.0|-0.134|0.101|||MMRM|||Week 1 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.101|-0.134|0.784
72518892|NCT05109702|144567695|SUPERIORITY||LS Mean Difference|0.06|STANDARD_ERROR_OF_MEAN|0.06||0.324|TWO_SIDED|95.0|-0.058|0.176|||MMRM|||Week 2 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.176|-0.058|0.324
72518893|NCT05109702|144567695|SUPERIORITY||LS Mean Difference|0.09|STANDARD_ERROR_OF_MEAN|0.06||0.13|TWO_SIDED|95.0|-0.027|0.21|||MMRM|||Week 4 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.210|-0.027|0.130
72569627|NCT02944383|144669977|SUPERIORITY||Median Difference (Net)|-0.41||||0.9081|TWO_SIDED|95.0|-10.77|10.75||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|EOS (average of week 10 and 12)||10.75|-10.77|0.9081
72624872|NCT00928668|144779215|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.56|STANDARD_ERROR_OF_MEAN|0.245|<|0.0001|TWO_SIDED|95.0|3.074|4.046|||Mixed Models Analysis|Adjusted using an analysis of variance with terms for centre, patients within centre, treatment and period (all as fixed effects)|Olo 10 mcg minus Placebo|||4.046|3.074|<0.0001
72518894|NCT05109702|144567695|SUPERIORITY||LS Mean Difference|0.23|STANDARD_ERROR_OF_MEAN|0.061||0|TWO_SIDED|95.0|0.11|0.35|||MMRM|||Week 8 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.350|0.110|0.000
72518895|NCT05109702|144567696|SUPERIORITY||LS Mean Difference|0.39|STANDARD_ERROR_OF_MEAN|0.623||0.532|TWO_SIDED|95.0|-0.834|1.613|||MMRM|||Week 2 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||1.613|-0.834|0.532
72518896|NCT05109702|144567696|SUPERIORITY||LS Mean Difference|0.72|STANDARD_ERROR_OF_MEAN|0.63||0.252|TWO_SIDED|95.0|-0.515|1.959|||MMRM|||Week 4 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||1.959|-0.515|0.252
72518897|NCT05109702|144567696|SUPERIORITY||LS Mean Difference|1.98|STANDARD_ERROR_OF_MEAN|0.636||0.002|TWO_SIDED|95.0|0.732|3.231|||MMRM|||Week 8 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||3.231|0.732|0.002
72518898|NCT05109702|144567697|SUPERIORITY||LS Mean Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.167||0.723|TWO_SIDED|95.0|-0.386|0.268|||MMRM|||Week 1 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.268|-0.386|0.723
72518899|NCT05109702|144567697|SUPERIORITY||LS Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.167||0.254|TWO_SIDED|95.0|-0.519|0.137|||MMRM|||Week 2 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.137|-0.519|0.254
72518900|NCT05109702|144567697|SUPERIORITY||LS Mean Difference|-0.36|STANDARD_ERROR_OF_MEAN|0.169||0.034|TWO_SIDED|95.0|-0.69|-0.028|||MMRM|||Week 4 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||-0.028|-0.690|0.034
72518901|NCT05109702|144567697|SUPERIORITY||LS Mean Difference|0.08|STANDARD_ERROR_OF_MEAN|0.171||0.64|TWO_SIDED|95.0|-0.255|0.414|||MMRM|||Week 8 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.414|-0.255|0.640
72518902|NCT05109702|144567698|SUPERIORITY|Week 1 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.|LS Mean Difference|1.45|STANDARD_DEVIATION|2.893||0.615|TWO_SIDED|95.0|-4.223|7.133|||MMRM|||||7.133|-4.223|0.615
72518903|NCT05109702|144567698|SUPERIORITY||LS Mean Difference|4.81|STANDARD_DEVIATION|2.894||0.097|TWO_SIDED|95.0|-0.866|10.494|||MMRM|||Week 2 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||10.494|-0.866|0.097
72518904|NCT05109702|144567698|SUPERIORITY||LS Mean Difference|1.06|STANDARD_DEVIATION|2.93||0.718|TWO_SIDED|95.0|-4.69|6.81|||MMRM|||Week 4 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||6.810|-4.690|0.718
72569628|NCT02944383|144669977|SUPERIORITY||Median Difference (Net)|-2.38||||0.548|TWO_SIDED|95.0|-11.82|6.86||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|EOS (average of week 10 and 12)||6.86|-11.82|0.5480
72569629|NCT02944383|144669978|SUPERIORITY|||||||0.1485||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 2||||0.1485
72569630|NCT02944383|144669978|SUPERIORITY|||||||0.6008||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 2||||0.6008
72569631|NCT02944383|144669978|SUPERIORITY|||||||0.9409||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 6||||0.9409
72624873|NCT00928668|144779215|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.224|STANDARD_ERROR_OF_MEAN|0.249|<|0.0001|TWO_SIDED|95.0|3.731|4.717|||Mixed Models Analysis|Adjusted using an analysis of variance with terms for centre, patients within centre, treatment and period (all as fixed effects)|Form 20 mcg minus Placebo|||4.717|3.731|<0.0001
72518905|NCT05109702|144567698|SUPERIORITY||LS Mean Difference|3.09|STANDARD_ERROR_OF_MEAN|2.963||0.298|TWO_SIDED|95.0|-2.728|8.903|||MMRM|||Week 8 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||8.903|-2.728|0.298
72518906|NCT05109702|144567699|SUPERIORITY||LS Mean Difference|2.67|STANDARD_ERROR_OF_MEAN|2.814||0.343|TWO_SIDED|95.0|-2.854|8.191|||MMRM|||Week 1 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors||8.191|-2.854|0.343
72405542|NCT00773175|144319233|SUPERIORITY||Mean Difference (Final Values)|-0.4||||0.0658|TWO_SIDED|95.0|-0.9|0.0|||ANOVA|From Analysis of Variance (ANOVA) model with center and treatment as factors.|Treatment difference = SC minus IV.|||0.0|-0.9|0.0658
72518907|NCT05109702|144567699|SUPERIORITY||LS Mean Difference|3.71|STANDARD_ERROR_OF_MEAN|2.814||0.188|TWO_SIDED|95.0|-1.813|9.232|||MMRM|||Week 2 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||9.232|-1.813|0.188
72518908|NCT05109702|144567699|SUPERIORITY||LS Mean Difference|2.55|STANDARD_ERROR_OF_MEAN|2.849||0.371|TWO_SIDED|95.0|-3.04|8.143|||MMRM|||Week 4 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||8.143|-3.040|0.371
72518909|NCT05109702|144567699|SUPERIORITY||LS Mean Difference|6.92|STANDARD_ERROR_OF_MEAN|2.883||0.017|TWO_SIDED|95.0|1.259|12.573|||MMRM|||Week 8 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||12.573|1.259|0.017
72518910|NCT05109702|144567700|SUPERIORITY||LS Mean Difference|0.85|STANDARD_ERROR_OF_MEAN|2.7||0.754|TWO_SIDED|95.0|-4.452|6.147|||MMRM|||Week 1 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||6.147|-4.452|0.754
72518911|NCT05109702|144567700|SUPERIORITY||LS Mean Difference|2.43|STANDARD_ERROR_OF_MEAN|2.7||0.368|TWO_SIDED|95.0|-2.865|7.731|||MMRM|||Week 2 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||7.731|-2.865|0.368
72518912|NCT05109702|144567700|SUPERIORITY||LS Mean Difference|1.35|STANDARD_ERROR_OF_MEAN|2.734||0.621|TWO_SIDED|95.0|-4.014|6.715|||MMRM|||Week 4 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||6.715|-4.014|0.621
72518913|NCT05109702|144567700|SUPERIORITY||LS Mean Difference|4.74|STANDARD_ERROR_OF_MEAN|2.766||0.087|TWO_SIDED|95.0|-0.688|10.168|||MMRM|||Week 8 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||10.168|-0.688|0.087
72518914|NCT05109702|144567701|SUPERIORITY||LS Mean Difference|4.23|STANDARD_ERROR_OF_MEAN|2.646||0.11|TWO_SIDED|95.0|-0.958|9.425|||MMRM|||Week 1 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors||9.425|-0.958|0.110
72405543|NCT00773175|144319234|SUPERIORITY||Mean Difference (Net)|-1.0||||0.6208|TWO_SIDED|95.0|-4.8|2.9|||ANOVA|From ANOVA model with center and treatment as factors|Treatment difference = SC minus IV|||2.9|-4.8|0.6208
72405544|NCT00773175|144319236|SUPERIORITY|||||||0.0685||||||Cochran-Mantel-Haenszel (CMH) test controlling for center|Cochran-Mantel-Haenszel|Question 1||||||0.0685
72518915|NCT05109702|144567701|SUPERIORITY||LS Mean Difference|2.66|STANDARD_ERROR_OF_MEAN|2.647||0.315|TWO_SIDED|95.0|-2.535|7.855|||MMRM|||Week 2 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors||7.855|-2.535|0.315
72569632|NCT02944383|144669978|SUPERIORITY|||||||0.9292||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 6||||0.9292
72405545|NCT00773175|144319236|SUPERIORITY|||||||0.0004||||||CMH test controlling for center|Cochran-Mantel-Haenszel|Question 2||||||0.0004
72405546|NCT00773175|144319236|SUPERIORITY|||||||0.6861||||||CMH test controlling for center|Cochran-Mantel-Haenszel|Question 3||||||0.6861
72405547|NCT00773175|144319236|SUPERIORITY|||||||0.2323||||||CMH test controlling for center|Cochran-Mantel-Haenszel|Question 4||||||0.2323
72405548|NCT00773175|144319237|SUPERIORITY|||||||0.0033||||||CMH test controlling for center|Cochran-Mantel-Haenszel|Effectiveness||||||0.0033
72405549|NCT00773175|144319237|SUPERIORITY||||||<|0.0001||||||CMH test controlling for center|Cochran-Mantel-Haenszel|Degree of difficulty||||||< 0.0001
72405550|NCT00773175|144319238|SUPERIORITY|||||||0.2012||||||CMH test controlling for Center|Cochran-Mantel-Haenszel|Question 1||||||0.2012
72405551|NCT00773175|144319238|SUPERIORITY||||||<|0.0001||||||CMH test controlling for center|Cochran-Mantel-Haenszel|Question 2||||||< 0.0001
72405552|NCT00773175|144319238|SUPERIORITY|||||||0.1302||||||CMH test controlling for center|Cochran-Mantel-Haenszel|Question 4||||||0.1302
72518916|NCT05109702|144567701|SUPERIORITY||LS Mean Difference|2.67|STANDARD_DEVIATION|2.678||0.318|TWO_SIDED|95.0|-2.582|7.928|||MMRM|||Week 4 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors||7.928|-2.582|0.318
72518917|NCT05109702|144567701|SUPERIORITY||LS Mean Difference|2.79|STANDARD_ERROR_OF_MEAN|2.71||0.303|TWO_SIDED|95.0|-2.525|8.111|||MMRM|||Week 8 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors||8.111|-2.525|0.303
72518918|NCT05109702|144567702|SUPERIORITY||LS Mean Difference|4.44|STANDARD_ERROR_OF_MEAN|2.975||0.136|TWO_SIDED|95.0|-1.402|10.273|||MMRM|||Week 1 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors||10.273|-1.402|0.136
72518919|NCT05109702|144567702|SUPERIORITY||LS Mean Difference|4.13|STANDARD_ERROR_OF_MEAN|2.972||0.165|TWO_SIDED|95.0|-1.7|9.966|||MMRM|||Week 2 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||9.966|-1.700|0.165
72518920|NCT05109702|144567702|SUPERIORITY||LS Mean Difference|1.3|STANDARD_ERROR_OF_MEAN|3.008||0.665|TWO_SIDED|95.0|-4.6|7.207|||MMRM|||Week 4 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||7.207|-4.600|0.665
72405553|NCT00773175|144319238|SUPERIORITY|||||||0.0852||||||CMH test controlling for center|Cochran-Mantel-Haenszel|Question 5||||||0.0852
72518921|NCT05109702|144567702|SUPERIORITY||LS Mean Difference|5.02|STANDARD_ERROR_OF_MEAN|3.043||0.099|TWO_SIDED|95.0|-0.95|10.995|||MMRM|||Week 8 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||10.995|-0.950|0.099
72518922|NCT05109702|144567703|SUPERIORITY||LS Mean Difference|0.51|STANDARD_ERROR_OF_MEAN|2.926||0.861|TWO_SIDED|95.0|-5.232|6.254|||MMRM|||Week 1 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors||6.254|-5.232|0.861
72518923|NCT05109702|144567703|SUPERIORITY||LS Mean Difference|1.76|STANDARD_ERROR_OF_MEAN|2.925||0.548|TWO_SIDED|95.0|-3.983|7.497|||MMRM|||Week 2 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors||7.497|-3.983|0.548
72518924|NCT05109702|144567703|SUPERIORITY||LS Mean Difference|3.97|STANDARD_ERROR_OF_MEAN|2.96||0.18|TWO_SIDED|95.0|-1.839|9.777|||MMRM|||Week 4 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors||9.777|-1.839|0.180
72518925|NCT05109702|144567703|SUPERIORITY||LS Mean Difference|3.93|STANDARD_ERROR_OF_MEAN|2.993||0.189|TWO_SIDED|95.0|-1.941|9.807|||MMRM|||Week 8 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors||9.807|-1.941|0.189
72569633|NCT02944383|144669978|SUPERIORITY|||||||0.8455||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.8455
72569634|NCT02944383|144669978|SUPERIORITY|||||||0.5256||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.5256
72569635|NCT02944383|144669978|SUPERIORITY|||||||0.9217||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.9217
72405554|NCT00773175|144319238|SUPERIORITY|||||||0.0275||||||CMH test controlling for center|Cochran-Mantel-Haenszel|Question 6||||||0.0275
72405555|NCT00773175|144319244|SUPERIORITY|||||||0.0247|||||||Wilcoxon (Mann-Whitney)|||||||0.0247
72405556|NCT00773175|144319245|SUPERIORITY|||||||0.0007||||||CMH test controlling for center|Cochran-Mantel-Haenszel|||||||0.0007
72518926|NCT05109702|144567704|SUPERIORITY||LS Mean Difference|1.32|STANDARD_ERROR_OF_MEAN|2.608||0.613|TWO_SIDED|95.0|-3.799|6.438|||MMRM|||Week 1 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors||6.438|-3.799|0.613
72518927|NCT05109702|144567704|SUPERIORITY||LS Mean Difference|4.53|STANDARD_ERROR_OF_MEAN|2.609||0.083|TWO_SIDED|95.0|-0.586|9.653|||MMRM|||Week 2 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors||9.653|-0.586|0.083
72405557|NCT04127786|144319305|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of the 95 percent (%) confidence interval (CI) of the difference of the percentages between the test group (Group 1) and control groups (Group 2, Group 3) was greater than (\>) -5% at Day 42.|Percentage Difference|0.0|||||TWO_SIDED|95.0|-1.4|4.3||||||Primary Series: Cohort-I Group 1: VRVg-2 versus Primary Series: Cohort-I Group 2: Verorab®: Pediatric (\< 18 years)||4.3|-1.4|
72405558|NCT04127786|144319305|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of the 95% CI of the difference of the percentages between the test group (Group 1) and control groups (Group 2, Group 3) was \> -5% at Day 42.|Percentage Difference|1.2|||||TWO_SIDED|95.0|-0.6|6.4||||||Primary Series: Cohort-I Group 1: VRVg-2 versus Primary Series: Cohort-I Group 2: Verorab®: Adult (\>=18 years)||6.4|-0.6|
72405559|NCT04127786|144319305|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of the 95% CI of the difference of the percentages between the test group (Group 1) and control groups (Group 2, Group 3) was \> -5% at Day 42.|Percentage Difference|0.0|||||TWO_SIDED|95.0|-1.4|4.4||||||Primary Series: Cohort-I Group 1: VRVg-2 versus Primary Series: Cohort-I Group 3: Imovax Rabies: Pediatric (\< 18 years)||4.4|-1.4|
72518928|NCT05109702|144567704|SUPERIORITY||LS Mean Difference|3.67|STANDARD_ERROR_OF_MEAN|2.639||0.165|TWO_SIDED|95.0|-1.508|8.851|||MMRM|||Week 4 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors||8.851|-1.508|0.165
72518929|NCT05109702|144567704|SUPERIORITY||LS Mean Difference|4.28|STANDARD_ERROR_OF_MEAN|2.672||0.11|TWO_SIDED|95.0|-0.964|9.522|||MMRM|||Week 8 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors||9.522|-0.964|0.110
72518930|NCT05109702|144567705|SUPERIORITY||LS Mean Difference|3.57|STANDARD_ERROR_OF_MEAN|1.743||0.041|TWO_SIDED|95.0|0.154|6.994|||MMRM|||Week 1 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors||6.994|0.154|0.041
72518931|NCT05109702|144567705|SUPERIORITY||LS Mean Difference|2.7|STANDARD_ERROR_OF_MEAN|1.743||0.122|TWO_SIDED|95.0|-0.723|6.118|||MMRM|||Week 2 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors||6.118|-0.723|0.122
72518932|NCT05109702|144567705|SUPERIORITY||LS Mean Difference|4.6|STANDARD_ERROR_OF_MEAN|1.76||0.009|TWO_SIDED|95.0|1.146|8.056|||MMRM|||Week 4 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors||8.056|1.146|0.009
72518933|NCT05109702|144567705|SUPERIORITY||LS Mean Difference|4.04|STANDARD_ERROR_OF_MEAN|1.781||0.024|TWO_SIDED|95.0|0.544|7.536|||MMRM|||Week 8 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors||7.536|0.544|0.024
72518934|NCT05109702|144567706|SUPERIORITY||LS Mean Difference|0.14|STANDARD_ERROR_OF_MEAN|0.13||0.282|TWO_SIDED|95.0|-0.115|0.394|||MMRM|||Week 1 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors||0.394|-0.115|0.282
72518935|NCT05109702|144567706|SUPERIORITY||LS Mean Difference|0.12|STANDARD_ERROR_OF_MEAN|0.13||0.353|TWO_SIDED|95.0|-0.134|0.375|||MMRM|||Week 2 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors||0.375|-0.134|0.353
72405560|NCT04127786|144319305|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of the 95% CI of the difference of the percentages between the test group (Group 1) and control groups (Group 2, Group 3) was \> -5% at Day 42.|Percentage Difference|0.0|||||TWO_SIDED|95.0|-1.5|4.6||||||Primary Series: Cohort-I Group 1: VRVg-2 versus Primary Series: Cohort-I Group 3: Imovax Rabies: Adult (\>= 18 years)||4.6|-1.5|
72518936|NCT05109702|144567706|SUPERIORITY||LS Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.131||0.764|TWO_SIDED|95.0|-0.297|0.218|||MMRM|||Week 4 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors||0.218|-0.297|0.764
72518937|NCT05109702|144567706|SUPERIORITY||LS Mean Difference|0.22|STANDARD_ERROR_OF_MEAN|0.133||0.104|TWO_SIDED|95.0|-0.044|0.476|||MMRM|||Week 8 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors||0.476|-0.044|0.104
72518938|NCT05109702|144567707|SUPERIORITY||LS Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.15||0.969|TWO_SIDED|95.0|-0.3|0.288|||MMRM|||Week 1 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors||0.288|-0.300|0.969
72518939|NCT05109702|144567707|SUPERIORITY||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.15||0.504|TWO_SIDED|95.0|-0.194|0.394|||MMRM|||Week 2 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors||0.394|-0.194|0.504
72518940|NCT05109702|144567707|SUPERIORITY||LS Mean Difference|0.02|STANDARD_ERROR_OF_MEAN|0.152||0.915|TWO_SIDED|95.0|-0.281|0.314|||MMRM|||Week 4 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors||0.314|-0.281|0.915
72518941|NCT05109702|144567707|SUPERIORITY||LS Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|0.153||0.195|TWO_SIDED|95.0|-0.102|0.499|||MMRM|||Week 8 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors||0.499|-0.102|0.195
72518942|NCT05109702|144567708|SUPERIORITY||LS Mean Difference|0.16|STANDARD_ERROR_OF_MEAN|0.148||0.287|TWO_SIDED|95.0|-0.133|0.449|||MMRM|||Week 1 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors||0.449|-0.133|0.287
72518943|NCT05109702|144567708|SUPERIORITY||LS Mean Difference|0.17|STANDARD_ERROR_OF_MEAN|0.148||0.26|TWO_SIDED|95.0|-0.124|0.458|||MMRM|||Week 2 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors||0.458|-0.124|0.260
72518944|NCT05109702|144567708|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.15||0.987|TWO_SIDED|95.0|-0.296|0.291|||MMRM|||Week 4 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors||0.291|-0.296|0.987
72518945|NCT05109702|144567708|SUPERIORITY||LS Mean Difference|0.22|STANDARD_ERROR_OF_MEAN|0.151||0.143|TWO_SIDED|95.0|-0.075|0.519|||MMRM|||Week 8 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors||0.519|-0.075|0.143
72518946|NCT05109702|144567709|SUPERIORITY||LS Mean Difference|0.19|STANDARD_ERROR_OF_MEAN|0.151||-0.198|TWO_SIDED|95.0|-0.102|0.49|||MMRM|||Week 1 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.490|-0.102|-0.198
72518947|NCT05109702|144567709|SUPERIORITY||LS Mean Difference|0.27|STANDARD_ERROR_OF_MEAN|0.151||0.076|TWO_SIDED|95.0|-0.028|0.564|||MMRM|||Week 2 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.564|-0.028|0.076
72518948|NCT05109702|144567709|SUPERIORITY||LS Mean Difference|0.07|STANDARD_ERROR_OF_MEAN|0.152||0.656|TWO_SIDED|95.0|-0.231|0.367|||MMRM|||Week 4 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.367|-0.231|0.656
72518949|NCT05109702|144567709|SUPERIORITY||LS Mean Difference|0.15|STANDARD_ERROR_OF_MEAN|0.154||0.324|TWO_SIDED|95.0|-0.15|0.454|||MMRM|||Week 8 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.454|-0.150|0.324
72518950|NCT05109702|144567710|SUPERIORITY||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.146||0.477|TWO_SIDED|95.0|-0.182|0.39|||MMRM|||Week 1 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors||0.390|-0.182|0.477
72518951|NCT05109702|144567710|SUPERIORITY||LS Mean Difference|0.31|STANDARD_ERROR_OF_MEAN|0.146||0.033|TWO_SIDED|95.0|0.026|0.598|||MMRM|||Week 2 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors||0.598|0.026|0.033
72518952|NCT05109702|144567710|SUPERIORITY||LS Mean Difference|0.13|STANDARD_ERROR_OF_MEAN|0.147||0.374|TWO_SIDED|95.0|-0.158|0.42|||MMRM|||Week 4 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors||0.420|-0.158|0.374
72569636|NCT02944383|144669978|SUPERIORITY|||||||0.7401||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.7401
72569637|NCT02944383|144669978|SUPERIORITY|||||||0.9386||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||EOS (average of week 10 and 12)||||0.9386
72569638|NCT02944383|144669978|SUPERIORITY|||||||0.6352||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||EOS (average of week 10 and 12)||||0.6352
72569639|NCT02944383|144669979|SUPERIORITY|||||||0.0165||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.0165
72569640|NCT02944383|144669979|SUPERIORITY|||||||0.3075||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.3075
72569641|NCT02944383|144669979|SUPERIORITY|||||||0.1069||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.1069
72569642|NCT02944383|144669979|SUPERIORITY|||||||0.6101||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.6101
72405561|NCT04127786|144319306|SUPERIORITY|If the non-inferiority for VRVg-2 versus comparator vaccines was reached at Day 42, then superiority was demonstrated if the overall observed percentage of participants with an RVNA titer \>= 0.5 IU/mL at Day 42 was at least 99% in the VRVg-2 Group, with the lower limit of the 95% CI at least 97%.|Percentage Difference|100.0|||||TWO_SIDED|95.0|99.3|100.0||||||The secondary immunogenicity outcome measures were evaluated sequentially following a fixed-sequence method.||100|99.3|
72569643|NCT02944383|144669979|SUPERIORITY||Median Difference (Net)|-12.04||||0.0351|TWO_SIDED|95.0|-23.79|-1.08||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|EOS (average of week 10 and 12)||-1.08|-23.79|0.0351
72518953|NCT05109702|144567710|SUPERIORITY||LS Mean Difference|0.24|STANDARD_ERROR_OF_MEAN|0.149||0.114|TWO_SIDED|95.0|-0.056|0.529|||MMRM|||Week 8 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors||0.529|-0.056|0.114
72518954|NCT05109702|144567711|SUPERIORITY||Mean Difference (Final Values)|-0.17|STANDARD_ERROR_OF_MEAN|0.329||0.598|TWO_SIDED|95.0|-0.822|0.475|||t-test, 2 sided|||Immediately Upon Instillation at Week 1||0.475|-0.822|0.598
72518955|NCT05109702|144567711|SUPERIORITY||Mean Difference (Final Values)|-0.25|STANDARD_ERROR_OF_MEAN|0.268||0.343|TWO_SIDED|95.0|-0.783|0.273|||t-test, 2 sided|||1 Minute Post Instillation at Week 1||0.273|-0.783|0.343
72518956|NCT05109702|144567711|SUPERIORITY||Mean Difference (Final Values)|-0.23|STANDARD_ERROR_OF_MEAN|0.25||0.359|TWO_SIDED|95.0|-0.721|0.262|||t-test, 2 sided|||2 Minutes Post Instillation at Week 1||0.262|-0.721|0.359
72518957|NCT03812588|144567712|SUPERIORITY||Slope|7.9|STANDARD_ERROR_OF_MEAN|7.261||0.292|TWO_SIDED|||||Linear regression model of condition in predicting change in HRSD-24. P-value and coefficient are Medication:Track. Medication (Escitalopram or Placebo) with Track (RFM or CFM) as co-variates. The threshold for statistical significance was p\>0.05.|Regression, Linear|||||||0.292
72518958|NCT01392378|144567715|SUPERIORITY_OR_OTHER||GMC Ratio|0.81||||0.0856|TWO_SIDED|95.0|0.69|0.96||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 4: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||0.96|0.69|0.0856
72518959|NCT01392378|144567715|SUPERIORITY_OR_OTHER||GMC Ratio|0.99||||0.8546|TWO_SIDED|95.0|0.84|1.16||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 4: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.16|0.84|0.8546
72518960|NCT01392378|144567715|SUPERIORITY_OR_OTHER||GMC Ratio|0.73||||0.0012|TWO_SIDED|95.0|0.62|0.86||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 4: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||0.86|0.62|0.0012
72518961|NCT01392378|144567715|SUPERIORITY_OR_OTHER||GMC Ratio|1.02||||0.8414|TWO_SIDED|95.0|0.87|1.2||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 4: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.20|0.87|0.8414
72518962|NCT01392378|144567715|SUPERIORITY_OR_OTHER||GMC Ratio|0.83||||0.2412|TWO_SIDED|95.0|0.64|1.08||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 6B: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.08|0.64|0.2412
72518963|NCT01392378|144567715|SUPERIORITY_OR_OTHER||GMC Ratio|1.13||||0.4548|TWO_SIDED|95.0|0.88|1.44||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 6B: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.44|0.88|0.4548
72518964|NCT01392378|144567715|SUPERIORITY_OR_OTHER||GMC Ratio|0.69||||0.0093|TWO_SIDED|95.0|0.53|0.88||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 6B: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||0.88|0.53|0.0093
72518965|NCT01392378|144567715|SUPERIORITY_OR_OTHER||GMC Ratio|1.1||||0.8414|TWO_SIDED|95.0|0.86|1.42||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 6B: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.42|0.86|0.8414
72518966|NCT01392378|144567715|SUPERIORITY_OR_OTHER||GMC Ratio|0.87||||0.1749|TWO_SIDED|95.0|0.75|1.0||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 9V: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.00|0.75|0.1749
72518967|NCT01392378|144567715|SUPERIORITY_OR_OTHER||GMC Ratio|1.11||||0.3121|TWO_SIDED|95.0|0.96|1.27||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 9V: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.27|0.96|0.3121
72518968|NCT01392378|144567715|SUPERIORITY_OR_OTHER||GMC Ratio|0.89||||0.1351|TWO_SIDED|95.0|0.78|1.03||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 9V: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.03|0.78|0.1351
72569644|NCT02944383|144669979|SUPERIORITY||Median Difference (Net)|-3.15||||0.3746|TWO_SIDED|95.0|-9.86|4.25||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|EOS (average of week 10 and 12)||4.25|-9.86|0.3746
72569645|NCT02944383|144669980|SUPERIORITY|||||||0.0133||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.0133
72569646|NCT02944383|144669980|SUPERIORITY|||||||0.2044||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.2044
72624874|NCT00928668|144779216|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.025|STANDARD_ERROR_OF_MEAN|0.296|<|0.0001|TWO_SIDED|95.0|1.437|2.613|||Mixed Models Analysis|Adjusted using an analysis of variance with terms for centre, patients within centre, treatment and period (all as fixed effects)|Olo 2 mcg minus Placebo|||2.613|1.437|<0.0001
72624875|NCT00928668|144779216|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.38|STANDARD_ERROR_OF_MEAN|0.3|<|0.0001|TWO_SIDED|95.0|1.785|2.975|||Mixed Models Analysis|Adjusted using an analysis of variance with terms for centre, patients within centre, treatment and period (all as fixed effects)|Olo 5 mcg minus Placebo|||2.975|1.785|<0.0001
72624876|NCT00928668|144779216|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.549|STANDARD_ERROR_OF_MEAN|0.292|<|0.0001|TWO_SIDED|95.0|2.971|4.127|||Mixed Models Analysis|Adjusted using an analysis of variance with terms for centre, patients within centre, treatment and period (all as fixed effects)|Olo 10 mcg minus Placebo|||4.127|2.971|<0.0001
72624877|NCT00928668|144779216|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.208|STANDARD_ERROR_OF_MEAN|0.296|<|0.0001|TWO_SIDED|95.0|3.622|4.794|||Mixed Models Analysis|Adjusted using an analysis of variance with terms for centre, patients within centre, treatment and period (all as fixed effects)|Form 20 mcg minus Placebo|||4.794|3.622|<0.0001
72405562|NCT04127786|144319307|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of the 95% CI of the difference of the percentage between the test groups (Groups 1+4) and control groups (Groups 2+5, Groups 3+6) was \> -5% at Day 28.|Percentage Difference|0.0|||||TWO_SIDED|95.0|-1.4|4.3||||||Pooled Groups 1 and 4: VRVg-2 versus Pooled Groups 2 and 5: Verorab®: Pediatric (\< 18 years)||4.3|-1.4|
72518969|NCT01392378|144567715|SUPERIORITY_OR_OTHER||GMC Ratio|1.07||||0.8414|TWO_SIDED|95.0|0.93|1.24||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 9V: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.24|0.93|0.8414
72518970|NCT01392378|144567715|SUPERIORITY_OR_OTHER||GMC Ratio|0.83||||0.2158|TWO_SIDED|95.0|0.67|1.03||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 14: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.03|0.67|0.2158
72518971|NCT01392378|144567715|SUPERIORITY_OR_OTHER||GMC Ratio|0.88||||0.3279|TWO_SIDED|95.0|0.71|1.08||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 14: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.08|0.71|0.3279
72518972|NCT01392378|144567715|SUPERIORITY_OR_OTHER||GMC Ratio|0.88||||0.2472|TWO_SIDED|95.0|0.72|1.09||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 14: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.09|0.72|0.2472
72518973|NCT01392378|144567715|SUPERIORITY_OR_OTHER||GMC Ratio|0.98||||0.8414|TWO_SIDED|95.0|0.79|1.21||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 14: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.21|0.79|0.8414
72518974|NCT01392378|144567715|SUPERIORITY_OR_OTHER||GMC Ratio|0.95||||0.6193|TWO_SIDED|95.0|0.81|1.12||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 18C: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.12|0.81|0.6193
72518975|NCT01392378|144567715|SUPERIORITY_OR_OTHER||GMC Ratio|1.13||||0.3121|TWO_SIDED|95.0|0.96|1.32||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 18C: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.32|0.96|0.3121
72518976|NCT01392378|144567715|SUPERIORITY_OR_OTHER||GMC Ratio|0.82||||0.0191|TWO_SIDED|95.0|0.7|0.96||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 18C: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||0.96|0.70|0.0191
72518977|NCT01392378|144567715|SUPERIORITY_OR_OTHER||GMC Ratio|1.14||||0.8414|TWO_SIDED|95.0|0.97|1.33||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 18C: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.33|0.97|0.8414
72518978|NCT01392378|144567715|SUPERIORITY_OR_OTHER||GMC Ratio|0.9||||0.2412|TWO_SIDED|95.0|0.76|1.05||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 19F: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.05|0.76|0.2412
72518979|NCT01392378|144567715|SUPERIORITY_OR_OTHER||GMC Ratio|1.15||||0.3121|TWO_SIDED|95.0|0.99|1.35||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 19F: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.35|0.99|0.3121
72569647|NCT02944383|144669980|SUPERIORITY|||||||0.0855||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.0855
72569648|NCT02944383|144669980|SUPERIORITY|||||||0.5114||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.5114
72569649|NCT02944383|144669980|SUPERIORITY|||||||0.0289||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||EOS (average of week 10 and 12)||||0.0289
72569650|NCT02944383|144669980|SUPERIORITY|||||||0.295||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||EOS (average of week 10 and 12)||||0.2950
72624878|NCT00928668|144779217|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.907|STANDARD_ERROR_OF_MEAN|0.295|<|0.0001|TWO_SIDED|95.0|1.322|2.492|||Mixed Models Analysis|Adjusted using an analysis of variance with terms for centre, patients within centre, treatment and period (all as fixed effects)|Olo 2 mcg minus Placebo|||2.492|1.322|<0.0001
72624879|NCT00928668|144779217|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.474|STANDARD_ERROR_OF_MEAN|0.299|<|0.0001|TWO_SIDED|95.0|1.822|3.066|||Mixed Models Analysis|Adjusted using an analysis of variance with terms for centre, patients within centre, treatment and period (all as fixed effects)|Olo 5 mcg minus Placebo|||3.066|1.822|<0.0001
72518980|NCT01392378|144567715|SUPERIORITY_OR_OTHER||GMC Ratio|0.8||||0.0135|TWO_SIDED|95.0|0.68|0.94||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 19F: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||0.94|0.68|0.0135
72518981|NCT01392378|144567715|SUPERIORITY_OR_OTHER||GMC Ratio|1.03||||0.8414|TWO_SIDED|95.0|0.87|1.21||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 19F: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.21|0.87|0.8414
72518982|NCT01392378|144567715|SUPERIORITY_OR_OTHER||GMC Ratio|0.81||||0.1749|TWO_SIDED|95.0|0.66|1.0||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 23F: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.00|0.66|0.1749
72518983|NCT01392378|144567715|SUPERIORITY_OR_OTHER||GMC Ratio|1.15||||0.3121|TWO_SIDED|95.0|0.93|1.41||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 23F: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.41|0.93|0.3121
72518984|NCT01392378|144567715|SUPERIORITY_OR_OTHER||GMC Ratio|0.7||||0.0038|TWO_SIDED|95.0|0.57|0.86||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 23F: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||0.86|0.57|0.0038
72518985|NCT01392378|144567715|SUPERIORITY_OR_OTHER||GMC Ratio|1.03||||0.8414|TWO_SIDED|95.0|0.84|1.27||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 23F: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.27|0.84|0.8414
72518986|NCT01392378|144567715|SUPERIORITY_OR_OTHER||GMC Ratio|0.9||||0.2412|TWO_SIDED|95.0|0.76|1.06||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 1: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.06|0.76|0.2412
72518987|NCT01392378|144567715|SUPERIORITY_OR_OTHER||GMC Ratio|1.2||||0.2053|TWO_SIDED|95.0|1.02|1.41||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 1: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.41|1.02|0.2053
72518988|NCT01392378|144567715|SUPERIORITY_OR_OTHER||GMC Ratio|0.82||||0.0241|TWO_SIDED|95.0|0.7|0.96||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 1: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||0.96|0.70|0.0241
72518989|NCT01392378|144567715|SUPERIORITY_OR_OTHER||GMC Ratio|1.04||||0.8414|TWO_SIDED|95.0|0.88|1.22||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 1: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.22|0.88|0.8414
72518990|NCT01392378|144567715|SUPERIORITY_OR_OTHER||GMC Ratio|0.81||||0.0732|TWO_SIDED|95.0|0.69|0.94||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 3: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||0.94|0.69|0.0732
72518991|NCT01392378|144567715|SUPERIORITY_OR_OTHER||GMC Ratio|0.95||||0.609|TWO_SIDED|95.0|0.82|1.1||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 3: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.10|0.82|0.6090
72518992|NCT01392378|144567715|SUPERIORITY_OR_OTHER||GMC Ratio|0.65|||<|0.0001|TWO_SIDED|95.0|0.56|0.76||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 3: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||0.76|0.56|<0.0001
72518993|NCT01392378|144567715|SUPERIORITY_OR_OTHER||GMC Ratio|0.96||||0.8414|TWO_SIDED|95.0|0.82|1.11||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 3: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.11|0.82|0.8414
72518994|NCT01392378|144567715|SUPERIORITY_OR_OTHER||GMC Ratio|0.98||||0.7828|TWO_SIDED|95.0|0.82|1.16||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 5: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.16|0.82|0.7828
72518995|NCT01392378|144567715|SUPERIORITY_OR_OTHER||GMC Ratio|1.21||||0.2053|TWO_SIDED|95.0|1.02|1.43||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 5: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.43|1.02|0.2053
72518996|NCT01392378|144567715|SUPERIORITY_OR_OTHER||GMC Ratio|0.77||||0.0093|TWO_SIDED|95.0|0.65|0.92||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 5: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||0.92|0.65|0.0093
72518997|NCT01392378|144567715|SUPERIORITY_OR_OTHER||GMC Ratio|1.11||||0.8414|TWO_SIDED|95.0|0.93|1.31||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 5: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.31|0.93|0.8414
72518998|NCT01392378|144567715|SUPERIORITY_OR_OTHER||GMC Ratio|0.88||||0.2412|TWO_SIDED|95.0|0.73|1.07||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 6A: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.07|0.73|0.2412
72518999|NCT01392378|144567715|SUPERIORITY_OR_OTHER||GMC Ratio|1.14||||0.3121|TWO_SIDED|95.0|0.95|1.37||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 6A: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.37|0.95|0.3121
72519000|NCT01392378|144567715|SUPERIORITY_OR_OTHER||GMC Ratio|0.77||||0.0135|TWO_SIDED|95.0|0.64|0.93||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 6A: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||0.93|0.64|0.0135
72519001|NCT01392378|144567715|SUPERIORITY_OR_OTHER||GMC Ratio|1.11||||0.8414|TWO_SIDED|95.0|0.92|1.34||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 6A: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.34|0.92|0.8414
72519002|NCT01392378|144567715|SUPERIORITY_OR_OTHER||GMC Ratio|0.9||||0.2412|TWO_SIDED|95.0|0.79|1.03||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 7F: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.03|0.79|0.2412
72519003|NCT01392378|144567715|SUPERIORITY_OR_OTHER||GMC Ratio|1.03||||0.6652|TWO_SIDED|95.0|0.91|1.18||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 7F: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.18|0.91|0.6652
72519004|NCT01392378|144567715|SUPERIORITY_OR_OTHER||GMC Ratio|0.85||||0.0275|TWO_SIDED|95.0|0.75|0.98||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 7F: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||0.98|0.75|0.0275
72519005|NCT01392378|144567715|SUPERIORITY_OR_OTHER||GMC Ratio|1.06||||0.8414|TWO_SIDED|95.0|0.93|1.21||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 7F: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.21|0.93|0.8414
72519006|NCT01392378|144567715|SUPERIORITY_OR_OTHER||GMC Ratio|0.9||||0.2412|TWO_SIDED|95.0|0.76|1.06||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 19A: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.06|0.76|0.2412
72519007|NCT01392378|144567715|SUPERIORITY_OR_OTHER||GMC Ratio|1.13||||0.3121|TWO_SIDED|95.0|0.96|1.32||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 19A: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.32|0.96|0.3121
72519008|NCT01392378|144567715|SUPERIORITY_OR_OTHER||GMC Ratio|0.84||||0.0387|TWO_SIDED|95.0|0.72|0.99||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 19A: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||0.99|0.72|0.0387
72519009|NCT01392378|144567715|SUPERIORITY_OR_OTHER||GMC Ratio|1.04||||0.8414|TWO_SIDED|95.0|0.89|1.22||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 19A: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.22|0.89|0.8414
72519010|NCT01392378|144567717|SUPERIORITY_OR_OTHER||GMC Ratio|0.99||||0.935|TWO_SIDED|95.0|0.82|1.19||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 4: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.19|0.82|0.9350
72519011|NCT01392378|144567717|SUPERIORITY_OR_OTHER||GMC Ratio|1.11||||0.7918|TWO_SIDED|95.0|0.93|1.32||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 4: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.32|0.93|0.7918
72519012|NCT01392378|144567717|SUPERIORITY_OR_OTHER||GMC Ratio|0.96||||0.6922|TWO_SIDED|95.0|0.8|1.14||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 4: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.14|0.80|0.6922
72519013|NCT01392378|144567717|SUPERIORITY_OR_OTHER||GMC Ratio|1.11||||0.9765|TWO_SIDED|95.0|0.93|1.32||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 4: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.32|0.93|0.9765
72519014|NCT01392378|144567717|SUPERIORITY_OR_OTHER||GMC Ratio|0.95||||0.6915|TWO_SIDED|95.0|0.78|1.15||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 6B: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.15|0.78|0.6915
72519015|NCT01392378|144567717|SUPERIORITY_OR_OTHER||GMC Ratio|1.13||||0.7918|TWO_SIDED|95.0|0.94|1.36||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 6B: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.36|0.94|0.7918
72519016|NCT01392378|144567717|SUPERIORITY_OR_OTHER||GMC Ratio|0.9||||0.4389|TWO_SIDED|95.0|0.75|1.09||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 6B: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.09|0.75|0.4389
72519017|NCT01392378|144567717|SUPERIORITY_OR_OTHER||GMC Ratio|1.03||||0.9765|TWO_SIDED|95.0|0.85|1.24||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 6B: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.24|0.85|0.9765
72519018|NCT01392378|144567717|SUPERIORITY_OR_OTHER||GMC Ratio|0.99||||0.935|TWO_SIDED|95.0|0.87|1.14||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 9V: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.14|0.87|0.9350
72519019|NCT01392378|144567717|SUPERIORITY_OR_OTHER||GMC Ratio|1.03||||0.7918|TWO_SIDED|95.0|0.9|1.18||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 9V: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.18|0.90|0.7918
72519020|NCT01392378|144567717|SUPERIORITY_OR_OTHER||GMC Ratio|1.0||||0.943|TWO_SIDED|95.0|0.88|1.15||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 9V: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.15|0.88|0.9430
72519021|NCT01392378|144567717|SUPERIORITY_OR_OTHER||GMC Ratio|0.98||||0.9765|TWO_SIDED|95.0|0.85|1.12||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 9V: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.12|0.85|0.9765
72519022|NCT01392378|144567717|SUPERIORITY_OR_OTHER||GMC Ratio|0.89||||0.5167|TWO_SIDED|95.0|0.74|1.06||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 14: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.06|0.74|0.5167
72519023|NCT01392378|144567717|SUPERIORITY_OR_OTHER||GMC Ratio|0.92||||0.7918|TWO_SIDED|95.0|0.78|1.1||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 14: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.10|0.78|0.7918
72519024|NCT01392378|144567717|SUPERIORITY_OR_OTHER||GMC Ratio|0.87||||0.2514|TWO_SIDED|95.0|0.73|1.04||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 14: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.04|0.73|0.2514
72519025|NCT01392378|144567717|SUPERIORITY_OR_OTHER||GMC Ratio|1.0||||0.9872|TWO_SIDED|95.0|0.84|1.19||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 14: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.19|0.84|0.9872
72519026|NCT01392378|144567717|SUPERIORITY_OR_OTHER||GMC Ratio|0.85||||0.2582|TWO_SIDED|95.0|0.73|1.0||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 18C: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.00|0.73|0.2582
72519027|NCT01392378|144567717|SUPERIORITY_OR_OTHER||GMC Ratio|1.06||||0.7918|TWO_SIDED|95.0|0.91|1.23||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 18C: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.23|0.91|0.7918
72519028|NCT01392378|144567717|SUPERIORITY_OR_OTHER||GMC Ratio|0.86||||0.2514|TWO_SIDED|95.0|0.74|1.0||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 18C: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.00|0.74|0.2514
72519029|NCT01392378|144567717|SUPERIORITY_OR_OTHER||GMC Ratio|1.03||||0.9765|TWO_SIDED|95.0|0.88|1.2||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 18C: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.20|0.88|0.9765
72519030|NCT01392378|144567717|SUPERIORITY_OR_OTHER||GMC Ratio|1.06||||0.6915|TWO_SIDED|95.0|0.86|1.3||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 19F: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.30|0.86|0.6915
72569651|NCT02944383|144669981|SUPERIORITY|||||||0.1992||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.1992
72569652|NCT02944383|144669981|SUPERIORITY|||||||0.9945||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.9945
72569653|NCT02944383|144669981|SUPERIORITY|||||||0.5139||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.5139
72519031|NCT01392378|144567717|SUPERIORITY_OR_OTHER||GMC Ratio|1.13||||0.7918|TWO_SIDED|95.0|0.93|1.38||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 19F: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.38|0.93|0.7918
72519032|NCT01392378|144567717|SUPERIORITY_OR_OTHER||GMC Ratio|0.95||||0.6922|TWO_SIDED|95.0|0.78|1.15||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 19F: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.15|0.78|0.6922
72519033|NCT01392378|144567717|SUPERIORITY_OR_OTHER||GMC Ratio|1.01||||0.9872|TWO_SIDED|95.0|0.83|1.23||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 19F: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.23|0.83|0.9872
72519034|NCT01392378|144567717|SUPERIORITY_OR_OTHER||GMC Ratio|0.85||||0.3609|TWO_SIDED|95.0|0.7|1.04||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 23F: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.04|0.70|0.3609
72519035|NCT01392378|144567717|SUPERIORITY_OR_OTHER||GMC Ratio|1.08||||0.7918|TWO_SIDED|95.0|0.89|1.3||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 23F: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.30|0.89|0.7918
72519036|NCT01392378|144567717|SUPERIORITY_OR_OTHER||GMC Ratio|0.86||||0.2514|TWO_SIDED|95.0|0.71|1.05||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 23F: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.05|0.71|0.2514
72519037|NCT01392378|144567717|SUPERIORITY_OR_OTHER||GMC Ratio|1.04||||0.9765|TWO_SIDED|95.0|0.86|1.26||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 23F: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.26|0.86|0.9765
72519038|NCT01392378|144567717|SUPERIORITY_OR_OTHER||GMC Ratio|0.92||||0.6304|TWO_SIDED|95.0|0.79|1.08||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 1: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.08|0.79|0.6304
72519039|NCT01392378|144567717|SUPERIORITY_OR_OTHER||GMC Ratio|1.06||||0.7918|TWO_SIDED|95.0|0.91|1.24||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 1: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.24|0.91|0.7918
72519040|NCT01392378|144567717|SUPERIORITY_OR_OTHER||GMC Ratio|0.88||||0.2514|TWO_SIDED|95.0|0.75|1.03||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 1: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.03|0.75|0.2514
72519041|NCT01392378|144567717|SUPERIORITY_OR_OTHER||GMC Ratio|1.03||||0.9765|TWO_SIDED|95.0|0.88|1.2||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 1: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.20|0.88|0.9765
72519042|NCT01392378|144567717|SUPERIORITY_OR_OTHER||GMC Ratio|0.84||||0.2582|TWO_SIDED|95.0|0.71|1.01||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 3: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.01|0.71|0.2582
72519043|NCT01392378|144567717|SUPERIORITY_OR_OTHER||GMC Ratio|0.99||||0.9279|TWO_SIDED|95.0|0.84|1.18||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 3: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.18|0.84|0.9279
72519044|NCT01392378|144567717|SUPERIORITY_OR_OTHER||GMC Ratio|0.85||||0.2514|TWO_SIDED|95.0|0.72|1.01||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 3: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.01|0.72|0.2514
72519045|NCT01392378|144567717|SUPERIORITY_OR_OTHER||GMC Ratio|0.9||||0.9765|TWO_SIDED|95.0|0.76|1.07||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 3: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.07|0.76|0.9765
72519046|NCT01392378|144567717|SUPERIORITY_OR_OTHER||GMC Ratio|0.82||||0.1424|TWO_SIDED|95.0|0.71|0.96||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 5: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||0.96|0.71|0.1424
72519047|NCT01392378|144567717|SUPERIORITY_OR_OTHER||GMC Ratio|0.97||||0.7918|TWO_SIDED|95.0|0.84|1.12||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 5: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.12|0.84|0.7918
72519048|NCT01392378|144567717|SUPERIORITY_OR_OTHER||GMC Ratio|0.85||||0.2514|TWO_SIDED|95.0|0.73|0.98||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 5: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||0.98|0.73|0.2514
72519049|NCT01392378|144567717|SUPERIORITY_OR_OTHER||GMC Ratio|0.92||||0.9765|TWO_SIDED|95.0|0.79|1.07||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 5: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.07|0.79|0.9765
72519050|NCT01392378|144567717|SUPERIORITY_OR_OTHER||GMC Ratio|0.93||||0.6304|TWO_SIDED|95.0|0.78|1.1||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 6A: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.10|0.78|0.6304
72519051|NCT01392378|144567717|SUPERIORITY_OR_OTHER||GMC Ratio|1.04||||0.7918|TWO_SIDED|95.0|0.88|1.22||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 6A: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.22|0.88|0.7918
72519052|NCT01392378|144567717|SUPERIORITY_OR_OTHER||GMC Ratio|0.95||||0.6922|TWO_SIDED|95.0|0.81|1.13||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 6A: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.13|0.81|0.6922
72519053|NCT01392378|144567717|SUPERIORITY_OR_OTHER||GMC Ratio|0.97||||0.9765|TWO_SIDED|95.0|0.82|1.15||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 6A: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.15|0.82|0.9765
72519054|NCT01392378|144567717|SUPERIORITY_OR_OTHER||GMC Ratio|0.95||||0.6572|TWO_SIDED|95.0|0.84|1.08||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 7F: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.08|0.84|0.6572
72519055|NCT01392378|144567717|SUPERIORITY_OR_OTHER||GMC Ratio|0.98||||0.7918|TWO_SIDED|95.0|0.86|1.11||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 7F: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.11|0.86|0.7918
72569654|NCT02944383|144669981|SUPERIORITY|||||||0.8085||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.8085
72519056|NCT01392378|144567717|SUPERIORITY_OR_OTHER||GMC Ratio|0.89||||0.2514|TWO_SIDED|95.0|0.79|1.01||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 7F: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.01|0.79|0.2514
72569655|NCT02944383|144669981|SUPERIORITY||Median Difference (Net)|-0.77||||0.7644|TWO_SIDED|95.0|-6.31|4.85||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|EOS (average of week 10 and 12)||4.85|-6.31|0.7644
72569656|NCT02944383|144669981|SUPERIORITY||Mean Difference (Net)|1.33||||0.9499|TWO_SIDED|95.0|-4.34|6.66||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|EOS (average of week 10 and 12)||6.66|-4.34|0.9499
72569657|NCT02944383|144669982|SUPERIORITY|||||||0.1521||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.1521
72569658|NCT02944383|144669982|SUPERIORITY|||||||0.8982||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.8982
72569659|NCT02944383|144669982|SUPERIORITY|||||||0.6228||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.6228
72519057|NCT01392378|144567717|SUPERIORITY_OR_OTHER||GMC Ratio|1.0||||0.9872|TWO_SIDED|95.0|0.88|1.13||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 7F: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.13|0.88|0.9872
72519058|NCT01392378|144567717|SUPERIORITY_OR_OTHER||GMC Ratio|0.92||||0.6304|TWO_SIDED|95.0|0.78|1.09||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 19A: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.09|0.78|0.6304
72519059|NCT01392378|144567717|SUPERIORITY_OR_OTHER||GMC Ratio|1.04||||0.7918|TWO_SIDED|95.0|0.88|1.22||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 19A: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.22|0.88|0.7918
72519060|NCT01392378|144567717|SUPERIORITY_OR_OTHER||GMC Ratio|0.95||||0.6922|TWO_SIDED|95.0|0.8|1.12||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 19A: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.12|0.80|0.6922
72405563|NCT04127786|144319307|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of the 95% CI of the difference of the percentage between the test groups (Groups 1+4) and control groups (Groups 2+5, Groups 3+6) was \> -5% at Day 28.|Percentage Difference|-0.2|||||TWO_SIDED|95.0|-1.9|2.7||||||Pooled Groups 1 and 4: VRVg-2 versus Pooled Groups 2 and 5: Verorab®: Adult (\>=18 years)||2.7|-1.9|
72519061|NCT01392378|144567717|SUPERIORITY_OR_OTHER||GMC Ratio|0.95||||0.9765|TWO_SIDED|95.0|0.81|1.13||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 19A: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.13|0.81|0.9765
72519062|NCT01392378|144567719|SUPERIORITY_OR_OTHER||GMT Ratio|1.2||||0.7148|TWO_SIDED|95.0|0.82|1.66||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 4: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.66|0.82|0.7148
72519063|NCT01392378|144567719|SUPERIORITY_OR_OTHER||GMT Ratio|1.0||||0.7907|TWO_SIDED|95.0|0.75|1.45||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 4: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.45|0.75|0.7907
72519064|NCT01392378|144567719|SUPERIORITY_OR_OTHER||GMT Ratio|1.1||||0.4765|TWO_SIDED|95.0|0.81|1.6||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 4: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.60|0.81|0.4765
72519065|NCT01392378|144567719|SUPERIORITY_OR_OTHER||GMT Ratio|1.3||||0.5037|TWO_SIDED|95.0|0.89|1.76||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 4: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.76|0.89|0.5037
72519066|NCT01392378|144567719|SUPERIORITY_OR_OTHER||GMT Ratio|1.1||||0.9414|TWO_SIDED|95.0|0.52|2.17||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 6B: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||2.17|0.52|0.9414
72519067|NCT01392378|144567719|SUPERIORITY_OR_OTHER||GMT Ratio|0.9||||0.7907|TWO_SIDED|95.0|0.45|1.71||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 6B: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.71|0.45|0.7907
72519068|NCT01392378|144567719|SUPERIORITY_OR_OTHER||GMT Ratio|0.6||||0.29|TWO_SIDED|95.0|0.32|1.23||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 6B: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.23|0.32|0.2900
72519069|NCT01392378|144567719|SUPERIORITY_OR_OTHER||GMT Ratio|0.9||||0.8826|TWO_SIDED|95.0|0.44|1.77||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 6B: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.77|0.44|0.8826
72519070|NCT01392378|144567719|SUPERIORITY_OR_OTHER||GMT Ratio|0.5||||0.5823|TWO_SIDED|95.0|0.18|1.4||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 9V: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.40|0.18|0.5823
72519071|NCT01392378|144567719|SUPERIORITY_OR_OTHER||GMT Ratio|0.7||||0.7636|TWO_SIDED|95.0|0.27|1.8||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 9V: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.80|0.27|0.7636
72519072|NCT01392378|144567719|SUPERIORITY_OR_OTHER||GMT Ratio|0.4||||0.2407|TWO_SIDED|95.0|0.14|1.05||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 9V: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.05|0.14|0.2407
72519073|NCT01392378|144567719|SUPERIORITY_OR_OTHER||GMT Ratio|1.2||||0.8826|TWO_SIDED|95.0|0.43|3.22||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 9V: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||3.22|0.43|0.8826
72405564|NCT04127786|144319307|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of the 95% CI of the difference of the percentage between the test groups (Groups 1+4) and control groups (Groups 2+5, Groups 3+6) was \> -5% at Day 28.|Percentage Difference|0.0|||||TWO_SIDED|95.0|-1.4|4.5||||||Pooled Groups 1 and 4: VRVg-2 versus Pooled Groups 3 and 6: Imovax Rabies®: Pediatric (\< 18 years)||4.5|-1.4|
72519074|NCT01392378|144567719|SUPERIORITY_OR_OTHER||GMT Ratio|0.5||||0.0961|TWO_SIDED|95.0|0.26|0.81||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 14: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||0.81|0.26|0.0961
72519075|NCT01392378|144567719|SUPERIORITY_OR_OTHER||GMT Ratio|0.7||||0.7636|TWO_SIDED|95.0|0.38|1.11||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 14: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.11|0.38|0.7636
72519076|NCT01392378|144567719|SUPERIORITY_OR_OTHER||GMT Ratio|0.7||||0.29|TWO_SIDED|95.0|0.39|1.19||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 14: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.19|0.39|0.2900
72519077|NCT01392378|144567719|SUPERIORITY_OR_OTHER||GMT Ratio|1.0||||0.8826|TWO_SIDED|95.0|0.6|1.82||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 14: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.82|0.60|0.8826
72519078|NCT01392378|144567719|SUPERIORITY_OR_OTHER||GMT Ratio|1.0||||0.9925|TWO_SIDED|95.0|0.65|1.54||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 18C: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.54|0.65|0.9925
72519079|NCT01392378|144567719|SUPERIORITY_OR_OTHER||GMT Ratio|0.8||||0.7636|TWO_SIDED|95.0|0.52|1.17||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 18C: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.17|0.52|0.7636
72519080|NCT01392378|144567719|SUPERIORITY_OR_OTHER||GMT Ratio|0.8||||0.3929|TWO_SIDED|95.0|0.53|1.22||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 18C: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.22|0.53|0.3929
72569660|NCT02944383|144669982|SUPERIORITY|||||||0.9622||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.9622
72569661|NCT02944383|144669982|SUPERIORITY|||||||0.6643||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||EOS (average of week 10 and 12)||||0.6643
72569662|NCT02944383|144669982|SUPERIORITY|||||||0.9071||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||EOS (average of week 10 and 12)||||0.9071
72569663|NCT02944383|144669983|SUPERIORITY|||||||0.5647||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.5647
72569664|NCT02944383|144669983|SUPERIORITY|||||||0.1073||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.1073
72569665|NCT02944383|144669983|SUPERIORITY|||||||0.3858||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.3858
72569666|NCT02944383|144669983|SUPERIORITY|||||||0.0916||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.0916
72569667|NCT02944383|144669983|SUPERIORITY||Median Difference (Net)|0.0||||0.9473|TWO_SIDED|95.0|-5.56|5.26||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|EOS (average of week 10 and 12)||5.26|-5.56|0.9473
72624880|NCT00928668|144779217|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.327|STANDARD_ERROR_OF_MEAN|0.29|<|0.0001|TWO_SIDED|95.0|2.752|3.902|||Mixed Models Analysis|Adjusted using an analysis of variance with terms for centre, patients within centre, treatment and period (all as fixed effects)|Olo 10 mcg minus Placebo|||3.902|2.752|<0.0001
72624881|NCT00928668|144779217|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.22|STANDARD_ERROR_OF_MEAN|0.294|<|0.0001|TWO_SIDED|95.0|3.637|4.803|||Mixed Models Analysis|Adjusted using an analysis of variance with terms for centre, patients within centre, treatment and period (all as fixed effects)|Form 20 mcg minus Placebo|||4.803|3.637|<0.0001
72624882|NCT00928668|144779218|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.229|STANDARD_ERROR_OF_MEAN|0.271|<|0.0001|TWO_SIDED|95.0|0.692|1.766|||Mixed Models Analysis|Adjusted using an analysis of variance with terms for centre, patients within centre, treatment and period (all as fixed effects)|Olo 2 mcg minus Placebo|||1.766|0.692|<0.0001
72519081|NCT01392378|144567719|SUPERIORITY_OR_OTHER||GMT Ratio|0.9||||0.8826|TWO_SIDED|95.0|0.62|1.43||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 18C: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.43|0.62|0.8826
72519082|NCT01392378|144567719|SUPERIORITY_OR_OTHER||GMT Ratio|1.2||||0.7433|TWO_SIDED|95.0|0.7|2.2||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 19F: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||2.20|0.70|0.7433
72519083|NCT01392378|144567719|SUPERIORITY_OR_OTHER||GMT Ratio|0.8||||0.7636|TWO_SIDED|95.0|0.46|1.35||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 19F: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.35|0.46|0.7636
72519084|NCT01392378|144567719|SUPERIORITY_OR_OTHER||GMT Ratio|0.6||||0.2407|TWO_SIDED|95.0|0.34|1.03||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 19F: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.03|0.34|0.2407
72519085|NCT01392378|144567719|SUPERIORITY_OR_OTHER||GMT Ratio|1.1||||0.8826|TWO_SIDED|95.0|0.61|1.83||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 19F: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.83|0.61|0.8826
72519086|NCT01392378|144567719|SUPERIORITY_OR_OTHER||GMT Ratio|0.9||||0.9414|TWO_SIDED|95.0|0.51|1.71||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 23F: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.71|0.51|0.9414
72519087|NCT01392378|144567719|SUPERIORITY_OR_OTHER||GMT Ratio|1.2||||0.7636|TWO_SIDED|95.0|0.68|2.14||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 23F: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||2.14|0.68|0.7636
72519088|NCT01392378|144567719|SUPERIORITY_OR_OTHER||GMT Ratio|0.9||||0.738|TWO_SIDED|95.0|0.5|1.63||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 23F: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.63|0.50|0.7380
72519089|NCT01392378|144567719|SUPERIORITY_OR_OTHER||GMT Ratio|0.9||||0.8826|TWO_SIDED|95.0|0.49|1.58||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 23F: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.58|0.49|0.8826
72519090|NCT01392378|144567719|SUPERIORITY_OR_OTHER||GMT Ratio|1.1||||0.9414|TWO_SIDED|95.0|0.67|1.65||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 1: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.65|0.67|0.9414
72519091|NCT01392378|144567719|SUPERIORITY_OR_OTHER||GMT Ratio|0.9||||0.7907|TWO_SIDED|95.0|0.58|1.43||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 1: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.43|0.58|0.7907
72519092|NCT01392378|144567719|SUPERIORITY_OR_OTHER||GMT Ratio|0.7||||0.2407|TWO_SIDED|95.0|0.43|1.04||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 1: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.04|0.43|0.2407
72519093|NCT01392378|144567719|SUPERIORITY_OR_OTHER||GMT Ratio|0.7||||0.267|TWO_SIDED|95.0|0.42|1.02||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 1: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.02|0.42|0.2670
72519094|NCT01392378|144567719|SUPERIORITY_OR_OTHER||GMT Ratio|0.8||||0.5823|TWO_SIDED|95.0|0.62|1.11||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 3: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.11|0.62|0.5823
72569668|NCT02944383|144669983|SUPERIORITY||Median Difference (Net)|4.54||||0.0911|TWO_SIDED|95.0|-1.83|9.95||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|EOS (average of week 10 and 12)||9.95|-1.83|0.0911
72569669|NCT02944383|144669984|SUPERIORITY|||||||0.4623||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.4623
72519095|NCT01392378|144567719|SUPERIORITY_OR_OTHER||GMT Ratio|0.9||||0.7636|TWO_SIDED|95.0|0.65|1.16||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 3: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.16|0.65|0.7636
72569670|NCT02944383|144669984|SUPERIORITY|||||||0.1678||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.1678
72405565|NCT04127786|144319307|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of the 95% CI of the difference of the percentage between the test groups (Groups 1+4) and control groups (Groups 2+5, Groups 3+6) was \> -5% at Day 28.|Percentage Difference|1.8|||||TWO_SIDED|95.0|-0.5|5.3||||||Pooled Groups 1 and 4: VRVg-2 versus Pooled Groups 3 and 6: Imovax Rabies®: Adult (\>= 18 years)||5.3|-0.5|
72519096|NCT01392378|144567719|SUPERIORITY_OR_OTHER||GMT Ratio|0.6||||0.0422|TWO_SIDED|95.0|0.48|0.86||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 3: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||0.86|0.48|0.0422
72519097|NCT01392378|144567719|SUPERIORITY_OR_OTHER||GMT Ratio|0.7||||0.267|TWO_SIDED|95.0|0.53|0.96||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 3: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||0.96|0.53|0.2670
72519098|NCT01392378|144567719|SUPERIORITY_OR_OTHER||GMT Ratio|1.1||||0.8454|TWO_SIDED|95.0|0.72|1.78||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 5: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.78|0.72|0.8454
72519099|NCT01392378|144567719|SUPERIORITY_OR_OTHER||GMT Ratio|1.3||||0.7636|TWO_SIDED|95.0|0.81|2.0||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 5: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||2.00|0.81|0.7636
72519100|NCT01392378|144567719|SUPERIORITY_OR_OTHER||GMT Ratio|0.7||||0.2824|TWO_SIDED|95.0|0.45|1.11||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 5: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.11|0.45|0.2824
72519101|NCT01392378|144567719|SUPERIORITY_OR_OTHER||GMT Ratio|1.3||||0.5155|TWO_SIDED|95.0|0.83|2.06||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 5: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||2.06|0.83|0.5155
72519102|NCT01392378|144567719|SUPERIORITY_OR_OTHER||GMT Ratio|0.7||||0.5823|TWO_SIDED|95.0|0.5|1.06||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 6A: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.06|0.50|0.5823
72519103|NCT01392378|144567719|SUPERIORITY_OR_OTHER||GMT Ratio|1.1||||0.7636|TWO_SIDED|95.0|0.78|1.7||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 6A: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.70|0.78|0.7636
72519104|NCT01392378|144567719|SUPERIORITY_OR_OTHER||GMT Ratio|0.8||||0.4644|TWO_SIDED|95.0|0.56|1.25||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 6A: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.25|0.56|0.4644
72519105|NCT01392378|144567719|SUPERIORITY_OR_OTHER||GMT Ratio|0.9||||0.8826|TWO_SIDED|95.0|0.59|1.31||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 6A: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.31|0.59|0.8826
72519106|NCT01392378|144567719|SUPERIORITY_OR_OTHER||GMT Ratio|0.8||||0.5823|TWO_SIDED|95.0|0.61|1.13||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 7F: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.13|0.61|0.5823
72519107|NCT01392378|144567719|SUPERIORITY_OR_OTHER||GMT Ratio|0.9||||0.7636|TWO_SIDED|95.0|0.65|1.23||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 7F: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.23|0.65|0.7636
72519108|NCT01392378|144567719|SUPERIORITY_OR_OTHER||GMT Ratio|0.8||||0.3299|TWO_SIDED|95.0|0.6|1.13||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 7F: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.13|0.60|0.3299
72569671|NCT02944383|144669984|SUPERIORITY|||||||0.439||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.4390
72569672|NCT02944383|144669984|SUPERIORITY|||||||0.129||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.1290
72569673|NCT02944383|144669984|SUPERIORITY|||||||0.9627||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||EOS (average of week 10 and 12)||||0.9627
72569674|NCT02944383|144669984|SUPERIORITY|||||||0.0911||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||EOS (average of week 10 and 12)||||0.0911
72624883|NCT00928668|144779218|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.825|STANDARD_ERROR_OF_MEAN|0.274|<|0.0001|TWO_SIDED|95.0|1.281|2.369|||Mixed Models Analysis|Adjusted using an analysis of variance with terms for centre, patients within centre, treatment and period (all as fixed effects)|Olo 5 mcg minus Placebo|||2.369|1.281|<0.0001
72405566|NCT04127786|144319308|NON_INFERIORITY|If the non-inferiority objective for VRVg-2 versus comparator vaccines at Day 28 was demonstrated, the overall non-inferiority of 2-dose VRVg-2 at Day 28 versus 3-dose Imovax Rabies® at Day 42 was demonstrated if the non-inferiority between pooled Groups 1+4 and Group 3 were both demonstrated in each age group.|Percentage Difference|0.0|||||TWO_SIDED|95.0|-1.4|4.4|||||Non-inferiority was demonstrated if the lower limit of the 95% CI of the difference of the percentage between 2-dose VRVg-2 at Day 28 and 3-dose Imovax Rabies® at Day 42 was \> -10%.|Pooled Groups 1 and 4: VRVg-2 at Day 28 versus Primary Series: Cohort-1 Group 3: Imovax Rabies® at Day 42: Pediatric (\< 18 years)||4.4|-1.4|
72519109|NCT01392378|144567719|SUPERIORITY_OR_OTHER||GMT Ratio|0.7||||0.267|TWO_SIDED|95.0|0.54|1.03||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 7F: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.03|0.54|0.2670
72519110|NCT01392378|144567719|SUPERIORITY_OR_OTHER||GMT Ratio|0.8||||0.5823|TWO_SIDED|95.0|0.48|1.23||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 19A: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.23|0.48|0.5823
72519111|NCT01392378|144567719|SUPERIORITY_OR_OTHER||GMT Ratio|1.1||||0.7907|TWO_SIDED|95.0|0.68|1.69||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 19A: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.69|0.68|0.7907
72519112|NCT01392378|144567719|SUPERIORITY_OR_OTHER||GMT Ratio|0.7||||0.2742|TWO_SIDED|95.0|0.43|1.09||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 19A: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.09|0.43|0.2742
72519113|NCT01392378|144567719|SUPERIORITY_OR_OTHER||GMT Ratio|0.7||||0.267|TWO_SIDED|95.0|0.42|1.05||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 19A: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.05|0.42|0.2670
72519114|NCT01392378|144567720|SUPERIORITY_OR_OTHER||GMC Ratio|0.93||||0.813|TWO_SIDED|95.0|0.71|1.22||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.22|0.71|0.813
72519115|NCT01392378|144567720|SUPERIORITY_OR_OTHER||GMC Ratio|1.03||||0.845|TWO_SIDED|95.0|0.79|1.34||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.34|0.79|0.845
72519116|NCT01392378|144567720|SUPERIORITY_OR_OTHER||GMC Ratio|0.85||||0.461|TWO_SIDED|95.0|0.65|1.11||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.11|0.65|0.461
72624884|NCT00928668|144779218|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.114|STANDARD_ERROR_OF_MEAN|0.27|<|0.0001|TWO_SIDED|95.0|1.578|2.65|||Mixed Models Analysis|Adjusted using an analysis of variance with terms for centre, patients within centre, treatment and period (all as fixed effects)|Olo 10 mcg minus Placebo|||2.650|1.578|<0.0001
72519117|NCT01392378|144567720|SUPERIORITY_OR_OTHER||GMC Ratio|0.89||||0.545|TWO_SIDED|95.0|0.68|1.16||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.16|0.68|0.545
72519118|NCT01392378|144567721|SUPERIORITY_OR_OTHER||GMC Ratio|0.91||||0.712|TWO_SIDED|95.0|0.79|1.06||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Pertussis PT: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.06|0.79|0.712
72519119|NCT01392378|144567721|SUPERIORITY_OR_OTHER||GMC Ratio|0.97||||0.837|TWO_SIDED|95.0|0.84|1.12||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Pertussis PT: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.12|0.84|0.837
72519120|NCT01392378|144567721|SUPERIORITY_OR_OTHER||GMC Ratio|0.9||||0.357|TWO_SIDED|95.0|0.78|1.04||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Pertussis PT: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.04|0.78|0.357
72519121|NCT01392378|144567721|SUPERIORITY_OR_OTHER||GMC Ratio|0.88||||0.19|TWO_SIDED|95.0|0.76|1.01||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Pertussis PT: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.01|0.76|0.190
72624885|NCT00928668|144779218|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.645|STANDARD_ERROR_OF_MEAN|0.27|<|0.0001|TWO_SIDED|95.0|2.11|3.181|||Mixed Models Analysis|Adjusted using an analysis of variance with terms for centre, patients within centre, treatment and period (all as fixed effects)|Form 20 mcg minus Placebo|||3.181|2.110|<0.0001
72624886|NCT01838226|144779221|SUPERIORITY||Mean Difference (Final Values)|0.7||||0.5|TWO_SIDED|95.0|-1.3|2.8|||Mixed Models Analysis|||||2.8|-1.3|0.50
72405567|NCT04127786|144319308|NON_INFERIORITY|If the non-inferiority objective for VRVg-2 versus comparator vaccines at Day 28 was demonstrated, the overall non-inferiority of 2-dose VRVg-2 at Day 28 versus 3-dose Imovax Rabies® at Day 42 was demonstrated if the non-inferiority between pooled Groups 1+4 and Group 3 were both demonstrated in each age group.|Percentage Difference|-1.7|||||TWO_SIDED|95.0|-3.1|3.0|||||Non-inferiority was demonstrated if the lower limit of the 95% CI of the difference of the percentage between 2-dose VRVg-2 at Day 28 and 3-dose Imovax Rabies® at Day 42 was \> -10%.|Pooled Groups 1 and 4: VRVg-2 at Day 28 versus Primary Series: Cohort-1 Group 3: Imovax Rabies® at Day 42: Adult (\>= 18 years)||3.0|-3.1|
72405568|NCT04127786|144319310|NON_INFERIORITY|If the superiority objective of VRVg-2 was reached at Day 28, the non-inferiority of 2-dose Imovax Rabies® at Day 28 versus 3-dose Imovax Rabies® at Day 42 was demonstrated if the lower limit of the 95% CI of the difference of the percentage between the 2-dose Imovax Rabies® at Day 28 and 3-dose Imovax Rabies® at Day 42 was \> -10%.|Percentage Difference|-1.3|||||TWO_SIDED|95.0|-4.4|1.3||||||Imovax Rabies® at Day 28 versus Imovax Rabies® at Day 42||1.3|-4.4|
72405569|NCT01904604|144319335|SUPERIORITY_OR_OTHER||Risk Difference (RD)|33.8||||0.005|TWO_SIDED|33.8|10.2|57.5||A one-sided test was used with the a priori threshold for statistical significance of 0.0125. No adjustments were made to the p-value.|Barnard's statistic|||The null hypothesis was that there was no difference between treatment groups. Subjects who did not complete the Week 52 oral food challenge were counted as treatment failures.||57.5|10.2|0.005
72405570|NCT01904604|144319335|SUPERIORITY_OR_OTHER||Risk Difference (RD)|36.0||||0.003|TWO_SIDED|36.0|12.6|59.4||A one-sided test was used with the a priori threshold for statistical significance of 0.0125. No adjustments were made to the p-value.|Barnard's statistic|||The null hypothesis was that there was no difference between treatment groups. Subjects who did not complete the Week 52 oral food challenge were counted as treatment failures.||59.4|12.6|0.003
72405571|NCT01904604|144319335|SUPERIORITY_OR_OTHER||Risk Difference (RD)|2.2||||0.48|TWO_SIDED|2.2|-25.8|30.1||A one-sided test was used with the a priori threshold for statistical significance of 0.0125. No adjustments were made to the p-value.|Barnard's statistic|||||30.1|-25.8|0.48
72405572|NCT01904604|144319339|SUPERIORITY_OR_OTHER|||||||0.8||||||No adjustments were made to the p-value.|Wilcoxon (Mann-Whitney)|The two-sided t approximation was used.||The null hypothesis was that there was no difference between treatment groups.||||0.80
72405573|NCT01904604|144319339|SUPERIORITY_OR_OTHER|||||||0.008||||||No adjustments were made to the p-value.|Wilcoxon (Mann-Whitney)|The two-sided t approximation was used.||The null hypothesis was that there was no difference between treatment groups.||||0.008
72405574|NCT01904604|144319339|SUPERIORITY_OR_OTHER|||||||0.01||||||No adjustments were made to the p-value.|Wilcoxon (Mann-Whitney)|The two-sided t approximation was used.||The null hypothesis was that there was no difference between treatment groups.||||0.01
72405575|NCT05124665|144319343|EQUIVALENCE|Hypothesis is that proportion of contacts accepting HIV testing between two study arms is equivalent.|Odds Ratio (OR)|4.6||||0.004|TWO_SIDED|95.0|1.6|12.9|||Mixed Models Analysis|Cluster adjusted for household.||||12.9|1.6|0.004
72405576|NCT05124665|144319343|EQUIVALENCE|Hypothesis is proportion of contacts accepting HIV testing is equivalent between the two study arms|Mean Difference (Net)|6.0||||0.006|TWO_SIDED|95.0|2.0|10.0|||t-test, 2 sided||Estimated value and confidence interval reflects the values multiplied by 100 (converting decimal to percentage).|||10|2|0.006
72519122|NCT01392378|144567721|SUPERIORITY_OR_OTHER||GMC Ratio|0.96||||0.813|TWO_SIDED|95.0|0.83|1.1||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Pertussis FHA: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.10|0.83|0.813
72519123|NCT01392378|144567721|SUPERIORITY_OR_OTHER||GMC Ratio|0.84||||0.136|TWO_SIDED|95.0|0.73|0.96||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Pertussis FHA: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||0.96|0.73|0.136
72519124|NCT01392378|144567721|SUPERIORITY_OR_OTHER||GMC Ratio|0.85||||0.104|TWO_SIDED|95.0|0.74|0.98||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Pertussis FHA: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||0.98|0.74|0.104
72405577|NCT05124665|144319344|EQUIVALENCE|Hypothesis is that the change in stigma score is equivalent between the two study arms.|Slope|2.2||||0.358|TWO_SIDED|95.0|-2.5|6.9|||Mixed Models Analysis|||Van Rie Perceived TB and HIV Stigma scales adapted and validated in the Ugandan context are used. Scores range from 0 to 100 (standardized scale)||6.9|-2.5|0.358
72405578|NCT05124665|144319345|EQUIVALENCE|Hypothesis is that the difference in stigma score is equivalent between the two study arms|Slope|2.61||||0.199|TWO_SIDED|95.0|-1.38|6.59|||Mixed Models Analysis|||||6.59|-1.38|0.199
72405579|NCT05124665|144319346|EQUIVALENCE|Hypothesis is no effect from perceived HIV Stigma on HIV Test Uptake|Coefficient from Structural Equation|0.00087||||0.03|TWO_SIDED|95.0|0.00007|0.00167|||Structural Equation Modeling|||||0.00167|0.00007|0.03
72405580|NCT05124665|144319347|EQUIVALENCE|Hypothesis is that TB stigma has no effect of HIV test uptake|Coefficient Structural Equation Model|0.0002||||0.64|TWO_SIDED|95.0|-0.0007|0.0011|||Structural Equation Modeling|||||0.0011|-0.0007|0.64
72405581|NCT05124665|144319348|EQUIVALENCE|Hypothesis is that proportion of index patient nominated household contacts accepting HIV testing is equivalent between two study arms||||||0.452|||||||Chi-squared|||||||0.452
72405582|NCT05124665|144319349|NON_INFERIORITY|Hypothesis is that the first tester's decision to test does not impact subsequent household contacts decision to test for HIV.|Risk Ratio (RR)|1.23||||0.264|TWO_SIDED|95.0|0.86|1.76|||Regression, Logistic|||||1.76|0.86|0.264
72405583|NCT05124665|144319350|EQUIVALENCE|Hypothesis is that the index patient and contact nominations will match equally regardless of study arm.|||||<|0.001|||||||Chi-squared|||||||<0.001
72519125|NCT01392378|144567721|SUPERIORITY_OR_OTHER||GMC Ratio|0.73|||<|0.001|TWO_SIDED|95.0|0.64|0.85||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Pertussis FHA: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||0.85|0.64|<0.001
72624887|NCT01838226|144779222|SUPERIORITY||Mean Difference (Net)|0.9|||||TWO_SIDED|95.0|-1.3|3.1|||Mixed Models Analysis|||||3.1|-1.3|
72519126|NCT01392378|144567721|SUPERIORITY_OR_OTHER||GMC Ratio|0.86||||0.712|TWO_SIDED|95.0|0.72|1.04||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Pertussis PRN: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.04|0.72|0.712
72519127|NCT01392378|144567721|SUPERIORITY_OR_OTHER||GMC Ratio|0.84||||0.206|TWO_SIDED|95.0|0.7|1.01||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Pertussis PRN: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.01|0.70|0.206
72519128|NCT01392378|144567721|SUPERIORITY_OR_OTHER||GMC Ratio|0.78||||0.066|TWO_SIDED|95.0|0.65|0.93||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Pertussis PRN: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||0.93|0.65|0.066
72519129|NCT01392378|144567721|SUPERIORITY_OR_OTHER||GMC Ratio|0.81||||0.085|TWO_SIDED|95.0|0.67|0.97||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Pertussis PRN: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||0.97|0.67|0.085
72519130|NCT01392378|144567722|SUPERIORITY_OR_OTHER||GMC Ratio|0.9||||0.712|TWO_SIDED|95.0|0.77|1.06||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Tetanus: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.06|0.77|0.712
72519131|NCT01392378|144567722|SUPERIORITY_OR_OTHER||GMC Ratio|0.86||||0.206|TWO_SIDED|95.0|0.74|1.0||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Tetanus: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.00|0.74|0.206
72519132|NCT01392378|144567722|SUPERIORITY_OR_OTHER||GMC Ratio|0.84||||0.104|TWO_SIDED|95.0|0.72|0.98||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Tetanus: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||0.98|0.72|0.104
72519133|NCT01392378|144567722|SUPERIORITY_OR_OTHER||GMC Ratio|0.74||||0.001|TWO_SIDED|95.0|0.63|0.87||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Tetanus: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||0.87|0.63|0.001
72519134|NCT01392378|144567722|SUPERIORITY_OR_OTHER||GMC Ratio|0.95||||0.813|TWO_SIDED|95.0|0.82|1.09||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Diphtheria: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.09|0.82|0.813
72519135|NCT01392378|144567722|SUPERIORITY_OR_OTHER||GMC Ratio|1.03||||0.837|TWO_SIDED|95.0|0.9|1.19||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Diphtheria: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.19|0.90|0.837
72519136|NCT01392378|144567722|SUPERIORITY_OR_OTHER||GMC Ratio|0.93||||0.534|TWO_SIDED|95.0|0.81|1.07||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Diphtheria: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.07|0.81|0.534
72624888|NCT01838226|144779223|SUPERIORITY||Mean Difference (Net)|-2.6|||||TWO_SIDED|95.0|-4.9|-0.2||||||||-0.2|-4.9|
72624889|NCT03232567|144779243|SUPERIORITY|||||||0.2451|||||||Fisher Exact|||||||0.2451
72519137|NCT01392378|144567722|SUPERIORITY_OR_OTHER||GMC Ratio|1.0||||0.961|TWO_SIDED|95.0|0.87|1.15||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Diphtheria: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.15|0.87|0.961
72519138|NCT01392378|144567723|SUPERIORITY_OR_OTHER||GMC Ratio|1.03||||0.85|TWO_SIDED|95.0|0.75|1.42||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.42|0.75|0.850
72519139|NCT01392378|144567723|SUPERIORITY_OR_OTHER||GMC Ratio|1.05||||0.837|TWO_SIDED|95.0|0.77|1.44||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.44|0.77|0.837
72519140|NCT01392378|144567723|SUPERIORITY_OR_OTHER||GMC Ratio|0.94||||0.695|TWO_SIDED|95.0|0.69|1.28||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.28|0.69|0.695
72519141|NCT01392378|144567723|SUPERIORITY_OR_OTHER||GMC Ratio|0.82||||0.408|TWO_SIDED|95.0|0.6|1.12||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.12|0.60|0.408
72624890|NCT03232567|144779243|SUPERIORITY|||||||0.0063|||||||Fisher Exact|||||||0.0063
72624891|NCT03232567|144779243|SUPERIORITY|||||||0.0063|||||||Fisher Exact|||||||0.0063
72624892|NCT03232567|144779244|SUPERIORITY|||||||0.4828|||||||Fisher Exact|||||||0.4828
72624893|NCT03232567|144779244|SUPERIORITY|||||||0.0996|||||||Fisher Exact|||||||0.0996
72624894|NCT03232567|144779244|SUPERIORITY|||||||0.0421|||||||Fisher Exact|||||||0.0421
72405584|NCT04144166|144319395|OTHER||||||||||||||See above|||"Mean value for visual CRT and median value for device CRI were calculated for each participant. 3 values were measured (each) for CRT and CRI. Mean value is equal to SUM(m1,m2,m3)/3.~Median value was then calculated for the set (57) of calculated mean visual CRT and mean device CRI. Median value is equal to the middle value of the series of mean values. All measurements are in units of seconds."|See above|||
72519142|NCT01392378|144567724|SUPERIORITY_OR_OTHER||GMT Ratio|0.95||||0.813|TWO_SIDED|95.0|0.69|1.3||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Poliomyelitis Type 1: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.30|0.69|0.813
72519143|NCT01392378|144567724|SUPERIORITY_OR_OTHER||GMT Ratio|0.92||||0.837|TWO_SIDED|95.0|0.68|1.25||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Poliomyelitis Type 1: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.25|0.68|0.837
72519144|NCT01392378|144567724|SUPERIORITY_OR_OTHER||GMT Ratio|0.94||||0.695|TWO_SIDED|95.0|0.68|1.28||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Poliomyelitis Type 1: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.28|0.68|0.695
72519145|NCT01392378|144567724|SUPERIORITY_OR_OTHER||GMT Ratio|0.98||||0.961|TWO_SIDED|95.0|0.71|1.36||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Poliomyelitis Type 1: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.36|0.71|0.961
72519146|NCT01392378|144567724|SUPERIORITY_OR_OTHER||GMT Ratio|1.18||||0.808|TWO_SIDED|95.0|0.85|1.65||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Poliomyelitis Type 2: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.65|0.85|0.808
72519147|NCT01392378|144567724|SUPERIORITY_OR_OTHER||GMT Ratio|1.09||||0.837|TWO_SIDED|95.0|0.8|1.5||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Poliomyelitis Type 2: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.50|0.80|0.837
72519148|NCT01392378|144567724|SUPERIORITY_OR_OTHER||GMT Ratio|0.92||||0.695|TWO_SIDED|95.0|0.66|1.28||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Poliomyelitis Type 2: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.28|0.66|0.695
72569675|NCT02944383|144669985|SUPERIORITY|||||||0.2882||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.2882
72624895|NCT03232567|144779246|SUPERIORITY|||||||0.0169|||||||Fisher Exact|||NasoVAX low dose vs placebo||||0.0169
72405585|NCT01481116|144319406|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.13|||<|0.001|TWO_SIDED|95.0|0.09|0.18||The testing procedure at 2-sided significance level of 0.025 was as follows: 1) TAK-875 25 mg vs. glimepiride, 2) TAK-875 50 mg plus metformin vs. glimepiride. If P-value was not greater than 0.025 at Step 1, then Step 2 was carried out.|Regression, Logistic|||Day 1 up to Week 78: Odds Ratios, corresponding confidence interval, and p-values were calculated using logistic regression with factors for treatment, country, schedule and baseline HbA1c value.||0.18|0.09|<0.001
72519149|NCT01392378|144567724|SUPERIORITY_OR_OTHER||GMT Ratio|0.82||||0.408|TWO_SIDED|95.0|0.58|1.15||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Poliomyelitis Type 2: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.15|0.58|0.408
72519150|NCT01392378|144567724|SUPERIORITY_OR_OTHER||GMT Ratio|1.07||||0.813|TWO_SIDED|95.0|0.78|1.46||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Poliomyelitis Type 3: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.46|0.78|0.813
72519151|NCT01392378|144567724|SUPERIORITY_OR_OTHER||GMT Ratio|0.8||||0.343|TWO_SIDED|95.0|0.59|1.08||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Poliomyelitis Type 3: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.08|0.59|0.343
72519152|NCT01392378|144567724|SUPERIORITY_OR_OTHER||GMT Ratio|1.12||||0.695|TWO_SIDED|95.0|0.82|1.52||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Poliomyelitis Type 3: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.52|0.82|0.695
72519153|NCT01392378|144567724|SUPERIORITY_OR_OTHER||GMT Ratio|0.95||||0.925|TWO_SIDED|95.0|0.69|1.31||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Poliomyelitis Type 3: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.31|0.69|0.925
72519154|NCT01392378|144567725|SUPERIORITY_OR_OTHER||GMC Ratio|1.08||||0.91|TWO_SIDED|95.0|0.81|1.43||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.43|0.81|0.910
72569676|NCT02944383|144669985|SUPERIORITY|||||||0.4474||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.4474
72519155|NCT01392378|144567725|SUPERIORITY_OR_OTHER||GMC Ratio|1.04||||0.85|TWO_SIDED|95.0|0.79|1.37||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.37|0.79|0.850
72519156|NCT01392378|144567725|SUPERIORITY_OR_OTHER||GMC Ratio|0.92||||0.868|TWO_SIDED|95.0|0.7|1.21||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.21|0.70|0.868
72519157|NCT01392378|144567725|SUPERIORITY_OR_OTHER||GMC Ratio|0.87||||0.914|TWO_SIDED|95.0|0.67|1.15||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.15|0.67|0.914
72519158|NCT01392378|144567726|SUPERIORITY_OR_OTHER||GMC Ratio|1.05||||0.91|TWO_SIDED|95.0|0.89|1.23||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Pertussis PT: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.23|0.89|0.910
72519159|NCT01392378|144567726|SUPERIORITY_OR_OTHER||GMC Ratio|1.04||||0.85|TWO_SIDED|95.0|0.89|1.22||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Pertussis PT: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.22|0.89|0.850
72519160|NCT01392378|144567726|SUPERIORITY_OR_OTHER||GMC Ratio|1.0||||0.961|TWO_SIDED|95.0|0.85|1.16||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Pertussis PT: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.16|0.85|0.961
72519161|NCT01392378|144567726|SUPERIORITY_OR_OTHER||GMC Ratio|0.99||||0.916|TWO_SIDED|95.0|0.85|1.16||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Pertussis PT: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.16|0.85|0.916
72519162|NCT01392378|144567726|SUPERIORITY_OR_OTHER||GMC Ratio|0.99||||0.91|TWO_SIDED|95.0|0.87|1.12||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Pertussis FHA: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.12|0.87|0.910
72519163|NCT01392378|144567726|SUPERIORITY_OR_OTHER||GMC Ratio|1.01||||0.909|TWO_SIDED|95.0|0.89|1.14||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Pertussis FHA: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.14|0.89|0.909
72519164|NCT01392378|144567726|SUPERIORITY_OR_OTHER||GMC Ratio|1.06||||0.868|TWO_SIDED|95.0|0.93|1.2||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Pertussis FHA: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.20|0.93|0.868
72624896|NCT03232567|144779246|SUPERIORITY|||||||0.0063|||||||Fisher Exact|||NasoVAX medium dose vs placebo||||0.0063
72519165|NCT01392378|144567726|SUPERIORITY_OR_OTHER||GMC Ratio|0.92||||0.914|TWO_SIDED|95.0|0.81|1.05||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Pertussis FHA: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.05|0.81|0.914
72519166|NCT01392378|144567726|SUPERIORITY_OR_OTHER||GMC Ratio|0.92||||0.91|TWO_SIDED|95.0|0.76|1.11||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Pertussis PRN: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.11|0.76|0.910
72519167|NCT01392378|144567726|SUPERIORITY_OR_OTHER||GMC Ratio|0.91||||0.85|TWO_SIDED|95.0|0.76|1.09||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Pertussis PRN: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.09|0.76|0.850
72519168|NCT01392378|144567726|SUPERIORITY_OR_OTHER||GMC Ratio|0.93||||0.868|TWO_SIDED|95.0|0.78|1.12||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Pertussis PRN: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.12|0.78|0.868
72519169|NCT01392378|144567726|SUPERIORITY_OR_OTHER||GMC Ratio|0.92||||0.914|TWO_SIDED|95.0|0.76|1.1||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Pertussis PRN: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.10|0.76|0.914
72519170|NCT01392378|144567727|SUPERIORITY_OR_OTHER||GMC Ratio|0.96||||0.91|TWO_SIDED|95.0|0.83|1.1||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Tetanus: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.10|0.83|0.910
72519171|NCT01392378|144567727|SUPERIORITY_OR_OTHER||GMC Ratio|0.94||||0.85|TWO_SIDED|95.0|0.82|1.07||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Tetanus: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.07|0.82|0.850
72624897|NCT03232567|144779246|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||NasoVAX high dose vs placebo||||<0.0001
72519172|NCT01392378|144567727|SUPERIORITY_OR_OTHER||GMC Ratio|0.98||||0.939|TWO_SIDED|95.0|0.86|1.12||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Tetanus: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.12|0.86|0.939
72519173|NCT01392378|144567727|SUPERIORITY_OR_OTHER||GMC Ratio|0.86||||0.279|TWO_SIDED|95.0|0.75|0.98||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Tetanus: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||0.98|0.75|0.279
72519174|NCT01392378|144567727|SUPERIORITY_OR_OTHER||GMC Ratio|0.86||||0.149|TWO_SIDED|95.0|0.76|0.97||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Diphtheria: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||0.97|0.76|0.149
72519175|NCT01392378|144567727|SUPERIORITY_OR_OTHER||GMC Ratio|1.02||||0.85|TWO_SIDED|95.0|0.91|1.14||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Diphtheria: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.14|0.91|0.850
72519176|NCT01392378|144567727|SUPERIORITY_OR_OTHER||GMC Ratio|0.89||||0.394|TWO_SIDED|95.0|0.79|0.99||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Diphtheria: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||0.99|0.79|0.394
72519177|NCT01392378|144567727|SUPERIORITY_OR_OTHER||GMC Ratio|0.98||||0.916|TWO_SIDED|95.0|0.87|1.1||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Diphtheria: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.10|0.87|0.916
72519178|NCT01392378|144567728|SUPERIORITY_OR_OTHER||GMC Ratio|1.26||||0.869|TWO_SIDED|95.0|0.9|1.76||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.76|0.90|0.869
72519179|NCT01392378|144567728|SUPERIORITY_OR_OTHER||GMC Ratio|1.07||||0.85|TWO_SIDED|95.0|0.78|1.48||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.48|0.78|0.850
72519180|NCT01392378|144567728|SUPERIORITY_OR_OTHER||GMC Ratio|1.1||||0.868|TWO_SIDED|95.0|0.8|1.52||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.52|0.80|0.868
72519181|NCT01392378|144567728|SUPERIORITY_OR_OTHER||GMC Ratio|1.1||||0.916|TWO_SIDED|95.0|0.8|1.52||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.52|0.80|0.916
72519182|NCT01392378|144567729|SUPERIORITY_OR_OTHER||GMT Ratio|0.98||||0.91|TWO_SIDED|95.0|0.78|1.24||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Poliomyelitis Type 1: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.24|0.78|0.910
72519183|NCT01392378|144567729|SUPERIORITY_OR_OTHER||GMT Ratio|1.05||||0.85|TWO_SIDED|95.0|0.83|1.32||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Poliomyelitis Type 1: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.32|0.83|0.850
72519184|NCT01392378|144567729|SUPERIORITY_OR_OTHER||GMT Ratio|1.09||||0.868|TWO_SIDED|95.0|0.87|1.37||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Poliomyelitis Type 1: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.37|0.87|0.868
72519185|NCT01392378|144567729|SUPERIORITY_OR_OTHER||GMT Ratio|1.02||||0.916|TWO_SIDED|95.0|0.81|1.28||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Poliomyelitis Type 1: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.28|0.81|0.916
72519186|NCT01392378|144567729|SUPERIORITY_OR_OTHER||GMT Ratio|0.99||||0.91|TWO_SIDED|95.0|0.79|1.23||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Poliomyelitis Type 2: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.23|0.79|0.910
72519187|NCT01392378|144567729|SUPERIORITY_OR_OTHER||GMT Ratio|0.94||||0.85|TWO_SIDED|95.0|0.76|1.17||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Poliomyelitis Type 2: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.17|0.76|0.850
72519188|NCT01392378|144567729|SUPERIORITY_OR_OTHER||GMT Ratio|0.95||||0.868|TWO_SIDED|95.0|0.77|1.17||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Poliomyelitis Type 2: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.17|0.77|0.868
72624898|NCT02284893|144779297|SUPERIORITY||Mean Difference (Final Values)|-0.34|STANDARD_ERROR_OF_MEAN|0.1001||0.0008|||||||Mixed Models Analysis|||||||0.0008
72405586|NCT01481116|144319406|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.13|||<|0.001|TWO_SIDED|95.0|0.09|0.18||The testing procedure at 2-sided significance level of 0.025 was as follows: 1) TAK-875 25 mg vs. glimepiride, 2) TAK-875 50 mg plus metformin vs. glimepiride. If P-value was not greater than 0.025 at Step 1, then Step 2 was carried out.|Regression, Logistic|||Day 1 up to Week 78: Odds Ratios, corresponding confidence interval, and p-values were calculated using logistic regression with factors for treatment, country, schedule and baseline HbA1c value.||0.18|0.09|<0.001
72405587|NCT01481116|144319406|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.13|||<|0.001|TWO_SIDED|95.0|0.09|0.18||The testing procedure at 2-sided significance level of 0.025 was as follows: 1) TAK-875 25 mg vs. glimepiride, 2) TAK-875 50 mg plus metformin vs. glimepiride. If P-value was not greater than 0.025 at Step 1, then Step 2 was carried out.|Regression, Logistic|||Day 1 up to Week 104: Odds Ratios, corresponding confidence interval, and p-values were calculated using logistic regression with factors for treatment, country, schedule and baseline HbA1c value.||0.18|0.09|<0.001
72405588|NCT01481116|144319406|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.13|||<|0.001|TWO_SIDED|95.0|0.09|0.18||The testing procedure at 2-sided significance level of 0.025 was as follows: 1) TAK-875 25 mg vs. glimepiride, 2) TAK-875 50 mg plus metformin vs. glimepiride. If P-value was not greater than 0.025 at Step 1, then Step 2 was carried out.|Regression, Logistic|||Day 1 up to Week 104: Odds Ratios, corresponding confidence interval, and p-values were calculated using logistic regression with factors for treatment, country, schedule and baseline HbA1c value.||0.18|0.09|<0.001
72519189|NCT01392378|144567729|SUPERIORITY_OR_OTHER||GMT Ratio|0.98||||0.916|TWO_SIDED|95.0|0.79|1.21||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Poliomyelitis Type 2: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.21|0.79|0.916
72519190|NCT01392378|144567729|SUPERIORITY_OR_OTHER||GMT Ratio|0.97||||0.91|TWO_SIDED|95.0|0.77|1.23||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Poliomyelitis Type 3: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.23|0.77|0.910
72519191|NCT01392378|144567729|SUPERIORITY_OR_OTHER||GMT Ratio|0.84||||0.85|TWO_SIDED|95.0|0.67|1.06||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Poliomyelitis Type 3: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.06|0.67|0.850
72519192|NCT01392378|144567729|SUPERIORITY_OR_OTHER||GMT Ratio|0.98||||0.939|TWO_SIDED|95.0|0.78|1.23||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Poliomyelitis Type 3: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.23|0.78|0.939
72519193|NCT01392378|144567729|SUPERIORITY_OR_OTHER||GMT Ratio|0.96||||0.916|TWO_SIDED|95.0|0.76|1.21||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Poliomyelitis Type 3: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.21|0.76|0.916
72624899|NCT02284893|144779298|SUPERIORITY||Risk Difference (RD)|12.2|STANDARD_ERROR_OF_MEAN|4.175||0.0034|||||||Regression, Logistic|the analysis was by Zhang et.al. method with adjustment for baseline A1c.The measure of interest is NOT odds ratio but Risk Difference.||||||0.0034
72405589|NCT01481116|144319407|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-1.31|STANDARD_ERROR_OF_MEAN|0.707||0.065|TWO_SIDED|95.0|-2.7|0.08||The testing procedure at 2-sided significance level of 0.025 was as follows: 1) TAK-875 25 mg vs. glimepiride, 2) TAK-875 50 mg plus metformin vs. glimepiride. If P-value was not greater than 0.025 at Step 1, then Step 2 was carried out.|Mixed Model Repeated Measures|Treatment, schedule and visit-by-treatment interaction as fixed factors and with baseline value and baseline value by visit interaction as covariates.||Change at Week 78||0.08|-2.70|0.065
72519194|NCT00180271|144567747|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.66|||<|0.001|TWO_SIDED|95.0|0.52|0.84||The trial involved prespecified event monitoring at up to 20 successive periods by an independent DSMB to permit trial termination if the CRT-D was superior to, inferior to, or not different from ICD according to prespecified stopping rules.|Log Rank||A Hazard ratio \< 1.0 would indicate that the result favors CRT-D.|The trial utilized a Wang-Tsiatis (delta=0.1) group-sequential design with 95% power to detect a hazard ratio of 0.75 at a two-sided significance level of 0.05. Primary analysis based on statistical evaluation comparing the life-table event-free survival time graphs for CRT-D and ICD-only arms of the trial. Stratified Cox proportional-hazards regression was used to estimate a hazard ratio and statistical significance was evaluated with the log-rank test. Stratified by center and ischemic status.||0.84|0.52|< 0.001
72519195|NCT00180271|144567748|SUPERIORITY||Hazard Ratio (HR)|0.67||||0.001|TWO_SIDED|95.0|0.53|0.86|||Andersen-Gill|Andersen-Gill model performed, adjusted for a previous HF event in the study, stratified by ischemic status and using robust variance estimation.|Model adjusted for previously experienced heart failure event in the study. Hazard Ratio (95% CI) comparing patients with a previous heart failure event to those patients without a prior heart failure event equaled 8.84 (6084, 11.43), p\<0.001.|||0.86|0.53|0.001
72519196|NCT02713789|144567755|SUPERIORITY|||||||0.827|||||||ANCOVA|||SEP2||||0.827
72519197|NCT02713789|144567755|SUPERIORITY|||||||0.594|||||||ANCOVA|||SEP2||||0.594
72519198|NCT02713789|144567755|SUPERIORITY|||||||0.274|||||||ANCOVA|||SEP3||||0.274
72519199|NCT02713789|144567755|SUPERIORITY|||||||0.766|||||||ANCOVA|||SEP3||||0.766
72519200|NCT02713789|144567756|SUPERIORITY|||||||0.384|||||||t-test, 1 sided|one-sided paired t-test at 5% significance level||||||0.384
72519201|NCT02713789|144567756|SUPERIORITY|||||||0.144|||||||t-test, 1 sided|one-sided paired t-test at 5% significance level||||||0.144
72519202|NCT02713789|144567756|SUPERIORITY|||||||0.022|||||||t-test, 1 sided|one-sided paired t-test at 5% significance level||||||0.022
72519203|NCT02713789|144567756|SUPERIORITY|||||||0.137|||||||t-test, 1 sided|p-value (one-sided) corresponds to the two sample t-test analysis||||||0.137
72519204|NCT02713789|144567756|SUPERIORITY|||||||0.123|||||||t-test, 1 sided|p-value (one-sided) corresponds to the two sample t-test analysis||||||0.123
72519205|NCT02713789|144567757|SUPERIORITY|||||||0.16|||||||t-test, 1 sided|one-sided paired t-test at 5% significance level||||||0.160
72519206|NCT02713789|144567757|SUPERIORITY|||||||0.208|||||||t-test, 1 sided|one-sided paired t-test at 5% significance level||||||0.208
72519207|NCT02713789|144567757|SUPERIORITY|||||||0.316|||||||t-test, 1 sided|one-sided paired t-test at 5% significance level||||||0.316
72519208|NCT02713789|144567757|SUPERIORITY|||||||0.221|||||||t-test, 1 sided|p-value (one-sided) corresponds to the two sample t-test analysis||||||0.221
72519209|NCT02713789|144567757|SUPERIORITY|||||||0.172|||||||t-test, 1 sided|p-value (one-sided) corresponds to the two sample t-test analysis||||||0.172
72519210|NCT02713789|144567758|SUPERIORITY|||||||0.199|||||||t-test, 1 sided|one-sided paired t-test at 5% significance level||||||0.199
72519211|NCT02713789|144567758|SUPERIORITY|||||||0.203|||||||t-test, 1 sided|one-sided paired t-test at 5% significance level||||||0.203
72519212|NCT02713789|144567758|SUPERIORITY|||||||0.5|||||||t-test, 1 sided|one-sided paired t-test at 5% significance level||||||0.500
72519213|NCT02713789|144567758|SUPERIORITY|||||||0.296|||||||t-test, 1 sided|p-value (one-sided) corresponds to the two sample t-test analysis||||||0.296
72624900|NCT02284893|144779299|SUPERIORITY||Mean Difference (Final Values)|-1.35|STANDARD_ERROR_OF_MEAN|0.2891||0.0001|||||||Mixed Models Analysis|||||||0.0001
72624901|NCT02284893|144779300|SUPERIORITY||Mean Difference (Final Values)|-20.9|STANDARD_ERROR_OF_MEAN|3.682||0.0001|||||||Mixed Models Analysis|||||||0.0001
72519214|NCT02713789|144567758|SUPERIORITY|||||||0.286|||||||t-test, 1 sided|p-value (one-sided) corresponds to the two sample t-test analysis||||||0.286
72519215|NCT02713789|144567759|SUPERIORITY|||||||0.449|||||||t-test, 1 sided|one-sided paired t-test at 5% significance level||||||0.449
72519216|NCT02713789|144567759|SUPERIORITY|||||||0.381|||||||t-test, 1 sided|one-sided paired t-test at 5% significance level||||||0.381
72519217|NCT02713789|144567759|SUPERIORITY|||||||0.011|||||||t-test, 1 sided|one-sided paired t-test at 5% significance level||||||0.011
72519218|NCT02713789|144567759|SUPERIORITY|||||||0.05|||||||t-test, 1 sided|p-value (one-sided) corresponds to the two sample t-test analysis||||||0.05
72519219|NCT02713789|144567759|SUPERIORITY|||||||0.09|||||||t-test, 1 sided|p-value (one-sided) corresponds to the two sample t-test analysis||||||0.09
72519220|NCT02713789|144567760|SUPERIORITY|||||||0.074|||||||t-test, 1 sided|one-sided paired t-test at 5% significance level||||||0.074
72519221|NCT02713789|144567760|SUPERIORITY|||||||0.468|||||||t-test, 1 sided|one-sided paired t-test at 5% significance level||||||0.468
72519222|NCT02713789|144567760|SUPERIORITY|||||||0.109|||||||t-test, 1 sided|one-sided paired t-test at 5% significance level||||||0.109
72519223|NCT02713789|144567760|SUPERIORITY|||||||0.493|||||||t-test, 1 sided|p-value (one-sided) corresponds to the two sample t-test analysis||||||0.493
72519224|NCT02713789|144567760|SUPERIORITY|||||||0.235|||||||t-test, 1 sided|p-value (one-sided) corresponds to the two sample t-test analysis||||||0.235
72519225|NCT02713789|144567761|SUPERIORITY|||||||0.136|||||||ANCOVA|||SEP1||||0.136
72519226|NCT02713789|144567761|SUPERIORITY|||||||0.498|||||||ANCOVA|||SEP1||||0.498
72519227|NCT02713789|144567761|SUPERIORITY|||||||0.369|||||||ANCOVA|||SEP4||||0.369
72519228|NCT02713789|144567761|SUPERIORITY|||||||0.337|||||||ANCOVA|||SEP4||||0.337
72519229|NCT02713789|144567761|SUPERIORITY|||||||0.16|||||||ANCOVA|||SEP5||||0.160
72519230|NCT00014911|144567773|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|44.0|||||TWO_SIDED|95.0|30.0|61.0|||Fisher Exact|||||61|30|
72519231|NCT00014911|144567774|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|28.0|||||TWO_SIDED|95.0|16.0|44.0|||Fisher Exact|||||44|16|
72519232|NCT00014911|144567775|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|58.0|||||TWO_SIDED|95.0|42.0|63.0|||Fisher Exact|||||63|42|
72519233|NCT00605072|144567785|SUPERIORITY_OR_OTHER|||||||0.008||95.0||||p-value for between group comparison (group\*visit)|Mixed Models Analysis|Adjusted for baseline AGE and Mini-Mental-State-Examination||||||0.008
72519234|NCT00605072|144567786|SUPERIORITY_OR_OTHER|||||||0.74||95.0|||||Mixed Models Analysis|adjusted for age||||||0.74
72519235|NCT00605072|144567787|SUPERIORITY_OR_OTHER|||||||0.81||95.0|||||Mixed Models Analysis|Adjusted for age at baseline||||||0.81
72519236|NCT00605072|144567788|SUPERIORITY_OR_OTHER|||||||0.87||95.0|||||Mixed Models Analysis|||||||0.87
72519237|NCT00605072|144567789|SUPERIORITY_OR_OTHER|||||||0.79||95.0|||||Mixed Models Analysis|||||||0.79
72519238|NCT02437487|144567797|SUPERIORITY||Relative Risk|1.2217|||||TWO_SIDED|95.0|0.7919|1.8849||||||||1.8849|0.7919|
72519239|NCT02437487|144567799|SUPERIORITY||Relative Risk|1.2624|||||TWO_SIDED|95.0|0.7668|2.0785||||||||2.0785|0.7668|
72519240|NCT02437487|144567800|SUPERIORITY||Relative Risk|1.2217|||||TWO_SIDED|95.0|0.7919|1.8849||||||||1.8849|0.7919|
72519241|NCT02437487|144567801|SUPERIORITY||Relative Risk|1.0878|||||TWO_SIDED|95.0|0.7383|1.6029||||||||1.6029|0.7383|
72519242|NCT01379924|144567802|SUPERIORITY||Odds Ratio (OR)|0.25||||0.037|TWO_SIDED|95.0|0.07|0.92|||Regression, Logistic|Adjusted for group differences at baseline and variables associated with differential study retention.|Usual care arm is reference group|Multiple logistic regression modeling used to compute adjusted odds ratios for 12-month follow-up data.||.92|.07|.037
72519243|NCT01379924|144567803|SUPERIORITY||Odds Ratio (OR)|0.24||||0.029|TWO_SIDED|95.0|0.07|0.86|||Regression, Logistic|Adjusted for any variables that differed between groups at baseline, and variables associated with likelihood of study retention at follow-up.|Usual care arm is reference group.|||.86|.07|.029
72519244|NCT01379924|144567804|SUPERIORITY||Odds Ratio (OR)|0.2||||0.017|TWO_SIDED|95.0|0.06|0.75|||Regression, Logistic|Adjusted for any variables that differed between groups at baseline, and variables associated with likelihood of study retention at follow-up.|Usual care arm is the reference group|||.75|.06|.017
72519245|NCT01379924|144567805|SUPERIORITY||Group by time interaction term coefficie|4.75|STANDARD_ERROR_OF_MEAN|3.84||0.217|TWO_SIDED||||||Mixed Models Analysis|Adjusted for any variables that differed between groups at baseline, and variables associated with likelihood of study retention at follow-up.||||||.217
72519246|NCT01379924|144567806|SUPERIORITY||Group by time interaction term coefficie|2.89|STANDARD_ERROR_OF_MEAN|3.77||0.444|TWO_SIDED||||||Mixed Models Analysis|Adjusted for any variables that differed between groups at baseline, and variables associated with likelihood of study retention at follow-up.||||||.444
72519247|NCT01379924|144567807|SUPERIORITY||Group by time interaction term coefficie|9.76|STANDARD_ERROR_OF_MEAN|3.82||0.011|TWO_SIDED||||||Mixed Models Analysis|Adjusted for any variables that differed between groups at baseline, and variables associated with likelihood of study retention at follow-up.||||||.011
72624902|NCT02421094|144779359|SUPERIORITY|||||||0.1621|||||||ANCOVA|||||||0.1621
72624903|NCT02421094|144779360|SUPERIORITY|||||||0.9835|||||||ANCOVA|||||||0.9835
72519248|NCT01379924|144567809|SUPERIORITY||Group by time interaction term coefficie|0.64|STANDARD_ERROR_OF_MEAN|0.59||0.758|TWO_SIDED||||||Mixed Models Analysis|Adjusted for any variables that differed between groups at baseline, and variables associated with likelihood of study retention at follow-up.||||||.758
72519249|NCT01379924|144567810|SUPERIORITY||Group by time interaction term coefficie|1.36|STANDARD_ERROR_OF_MEAN|0.6||0.024|TWO_SIDED||||||Mixed Models Analysis|Adjusted for any variables that differed between groups at baseline, and variables associated with likelihood of study retention at follow-up.||||||.024
72519250|NCT01379924|144567811|SUPERIORITY||Group by time interaction term coefficie|2.67|STANDARD_ERROR_OF_MEAN|2.88||0.354|TWO_SIDED||||||Mixed Models Analysis|Adjusted for any variables that differed between groups at baseline, and variables associated with likelihood of study retention at follow-up||||||.354
72519251|NCT01379924|144567812|SUPERIORITY||Group by time interaction term coefficie|4.43|STANDARD_ERROR_OF_MEAN|2.85||0.121|TWO_SIDED||||||Mixed Models Analysis|Adjusted for any variables that differed between groups at baseline, and variables associated with likelihood of study retention at follow-up.||||||.121
72519252|NCT01379924|144567813|SUPERIORITY||Group by time interaction term coefficie|3.67|STANDARD_ERROR_OF_MEAN|2.89||0.205|TWO_SIDED||||||Mixed Models Analysis|Adjusted for any variables that differed between groups at baseline, and variables associated with likelihood of study retention at follow-up.||||||.205
72519253|NCT01379924|144567814|SUPERIORITY||Group by time interaction term coefficie|0.65|STANDARD_ERROR_OF_MEAN|2.6||0.803|TWO_SIDED||||||Mixed Models Analysis|Adjusted for any variables that differed between groups at baseline, and variables associated with likelihood of study retention at follow-up.||||||.803
72519254|NCT01379924|144567815|SUPERIORITY||Group by time interaction term coefficie|2.41|STANDARD_ERROR_OF_MEAN|2.56||0.347|TWO_SIDED||||||Mixed Models Analysis|Adjusted for any variables that differed between groups at baseline, and variables associated with likelihood of study retention at follow-up.||||||.347
72519255|NCT01379924|144567816|SUPERIORITY||Group by time interaction term coefficie|-1.39|STANDARD_ERROR_OF_MEAN|2.59||0.591|TWO_SIDED||||||Mixed Models Analysis|Adjusted for any variables that differed between groups at baseline, and variables associated with likelihood of study retention at follow-up.||||||.591
72519256|NCT01230749|144567821|SUPERIORITY_OR_OTHER||Difference in LSM|-27.4||||0.006|TWO_SIDED|95.0|-46.792|-8.008|||ANCOVA|||||-8.008|-46.792|0.006
72519257|NCT01230749|144567821|SUPERIORITY_OR_OTHER||Difference in LSM|-20.47||||0.038|TWO_SIDED|95.0|-39.801|-1.142|||ANCOVA|||||-1.142|-39.801|0.038
72519258|NCT01230749|144567821|SUPERIORITY_OR_OTHER||Difference in LSM|-13.24||||0.178|TWO_SIDED|95.0|-32.635|6.151|||ANCOVA|||||6.151|-32.635|0.178
72519259|NCT01230749|144567822|SUPERIORITY_OR_OTHER||Difference in LSM|-28.28||||0.005|TWO_SIDED|95.0|-47.606|-8.957|||ANCOVA|||||-8.957|-47.606|0.005
72624904|NCT02421094|144779361|SUPERIORITY|||||||0.266|||||||ANCOVA|||||||0.2660
72624905|NCT04716894|144779371|OTHER||adjusted geometric mean (gMean) ratio(%)|197.77|||||TWO_SIDED|90.0|187.9|208.15|||||Ratio (%) = T/R\*100. Intra-individual geometric coefficient of variation (gCV) = 7.0.|Relative bioavailability. Model used was an analysis of variance (ANOVA) model on the logarithmic scale. Data were log-transformed (natural logarithm) prior to fitting the ANOVA model. The effect 'subjects' was considered as random effect, whereas 'treatment' was considered as fixed effect.||208.15|187.90|
72519260|NCT01230749|144567822|SUPERIORITY_OR_OTHER||Difference in LSM|-21.97||||0.025|TWO_SIDED|95.0|-41.154|-2.786|||ANCOVA|||||-2.786|-41.154|0.025
72519261|NCT01230749|144567822|SUPERIORITY_OR_OTHER||Difference in LSM|-17.71||||0.069|TWO_SIDED|95.0|-36.86|1.431|||ANCOVA|||||1.431|-36.860|0.069
72519262|NCT01230749|144567823|SUPERIORITY_OR_OTHER||Difference in LSM|2.76||||0.628|TWO_SIDED|95.0|-8.542|14.054|||ANCOVA|||||14.054|-8.542|0.628
72519263|NCT01230749|144567823|SUPERIORITY_OR_OTHER||Difference in LSM|13.7||||0.018|TWO_SIDED|95.0|2.392|25.008|||ANCOVA|||||25.008|2.392|0.018
72519264|NCT01230749|144567823|SUPERIORITY_OR_OTHER||Difference in LSM|5.87||||0.303|TWO_SIDED|95.0|-5.417|17.148|||ANCOVA|||||17.148|-5.417|0.303
72519265|NCT01230749|144567824|SUPERIORITY_OR_OTHER||Difference in LSM|-1.86||||0.041|TWO_SIDED|95.0|-3.634|-0.082|||ANCOVA|||||-0.082|-3.634|0.041
72519266|NCT01230749|144567824|SUPERIORITY_OR_OTHER||Difference in LSM|-0.26||||0.769|TWO_SIDED|95.0|-2.033|1.509|||ANCOVA|||||1.509|-2.033|0.769
72519267|NCT01230749|144567824|SUPERIORITY_OR_OTHER||Difference in LSM|-0.69||||0.444|TWO_SIDED|95.0|-2.463|1.091|||ANCOVA|||||1.091|-2.463|0.444
72519268|NCT01230749|144567825|SUPERIORITY_OR_OTHER||GMR mulitplied by 100 percent|95.1||||0.774|TWO_SIDED|90.0|71.031|127.324|||ANCOVA|||||127.324|71.031|0.774
72519269|NCT01230749|144567825|SUPERIORITY_OR_OTHER||GMR multiplied by 100 percent|89.9||||0.555|TWO_SIDED|90.0|66.567|121.403|||ANCOVA|||||121.403|66.567|0.555
72519270|NCT01230749|144567826|SUPERIORITY_OR_OTHER||GMR multiplied by 100 percent|100.17||||0.968|TWO_SIDED|90.0|93.217|107.647|||ANCOVA|||||107.647|93.217|0.968
72519271|NCT01230749|144567826|SUPERIORITY_OR_OTHER||GMR multiplied by 100 percent|101.18||||0.785|TWO_SIDED|90.0|94.179|108.7|||ANCOVA|||||108.700|94.179|0.785
72519272|NCT01230749|144567827|SUPERIORITY_OR_OTHER||GMR multiplied by 100 percent|133.27||||0.097|TWO_SIDED|90.0|100.275|177.115|||ANCOVA|||||177.115|100.275|0.097
72519273|NCT01230749|144567827|SUPERIORITY_OR_OTHER||GMR mulitplied by 100 percent|101.82||||0.917|TWO_SIDED|90.0|76.26|135.942|||ANCOVA|||||135.942|76.260|0.917
72519274|NCT01230749|144567828|SUPERIORITY_OR_OTHER||Difference in LSM|0.46||||0.295|TWO_SIDED|95.0|-0.408|1.323|||ANCOVA|||||1.323|-0.408|0.295
72519275|NCT01230749|144567828|SUPERIORITY_OR_OTHER||Difference in LSM|0.03||||0.941|TWO_SIDED|95.0|-0.838|0.904|||ANCOVA|||||0.904|-0.838|0.941
72519276|NCT01230749|144567828|SUPERIORITY_OR_OTHER||Difference in LSM|1.02||||0.022|TWO_SIDED|95.0|0.15|1.892|||ANCOVA|||||1.892|0.150|0.022
72519277|NCT00713284|144567860|OTHER||||||<|0.05|||||||t-test, 1 sided|||||||<0.05
72519278|NCT03127852|144567861|SUPERIORITY|||||||0.48|||||||t-test, 2 sided|||Poststudy between-group comparison of SF-36 physical component summary score.||||.48
72519279|NCT03127852|144567861|SUPERIORITY|||||||0.73|||||||t-test, 2 sided|||Poststudy between-group comparison of SF-36 mental component summary score.||||.73
72519280|NCT03127852|144567862|SUPERIORITY|||||||0.02|||||||t-test, 2 sided|||Poststudy between-group comparison of self-reported number of hospital visits.||||.02
72519281|NCT03127852|144567862|SUPERIORITY|||||||0.12|||||||t-test, 2 sided|||Poststudy between-group comparison of self-reported emergency department visits.||||.12
72519282|NCT03127852|144567862|SUPERIORITY|||||||0.39|||||||t-test, 2 sided|||Poststudy between-group comparison of self-reported number of clinic visits.||||.39
72519283|NCT03127852|144567862|SUPERIORITY|||||||0.28|||||||t-test, 2 sided|||Poststudy between-group comparison of self-reported number of family physician visits.||||.28
72519284|NCT03127852|144567863|SUPERIORITY|||||||0.74|||||||t-test, 2 sided|||Poststudy between-group comparison of SCHFI maintenance sub-scale.||||.74
72519285|NCT03127852|144567863|SUPERIORITY|||||||0.67|||||||t-test, 2 sided|||Poststudy between-group comparison of SCHFI management sub-scale.||||.67
72519286|NCT03127852|144567863|SUPERIORITY|||||||0.92|||||||t-test, 2 sided|||Poststudy between-group comparison of SCHFI confidence sub-scale.||||.92
72519287|NCT03127852|144567864|SUPERIORITY|||||||0.67|||||||t-test, 2 sided|||Poststudy between-group comparison of MLHFQ total score.||||.67
72519288|NCT03127852|144567864|SUPERIORITY|||||||0.43|||||||t-test, 2 sided|||Poststudy between-group comparison of MLHFQ physical domain score.||||.43
72519289|NCT03127852|144567864|SUPERIORITY|||||||0.64|||||||t-test, 2 sided|||Poststudy between-group comparison of MLHFQ emotional domain score.||||.64
72519290|NCT03127852|144567865|SUPERIORITY|||||||0.06|||||||t-test, 2 sided|||Poststudy between-group comparison of HADS anxiety sub-scale.||||.06
72519291|NCT03127852|144567865|SUPERIORITY|||||||0.77|||||||t-test, 2 sided|||Poststudy between-group comparison of HADS depression sub-scale.||||.77
72519292|NCT03127852|144567866|SUPERIORITY|||||||0.13|||||||t-test, 2 sided|||Poststudy between-group comparison of SEMCD6.||||.13
72519293|NCT02038790|144567901|SUPERIORITY_OR_OTHER||||||>|0.5|TWO_SIDED|||||Two-tailed level of significance of 0.05 and no adjustments made for the number of tests conducted.|Chi-squared|||||||>0.5000
72519294|NCT02038790|144567902|SUPERIORITY_OR_OTHER|||||||0.0196|TWO_SIDED|||||Two-tailed level of significance of 0.05 and no adjustments made for the number of tests conducted.|Chi-squared|||||||0.0196
72569677|NCT02944383|144669985|SUPERIORITY|||||||0.7875||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.7875
72519295|NCT02038790|144567903|SUPERIORITY_OR_OTHER|||||||0.0006|TWO_SIDED|||||Two-tailed level of significance of 0.05 and no adjustments made for the number of tests conducted.|Chi-squared|||||||0.0006
72519296|NCT02038790|144567904|SUPERIORITY_OR_OTHER|||||||0.4422|TWO_SIDED|||||Two-tailed level of significance of 0.05 and no adjustments made for the number of tests conducted.|Chi-squared|||||||0.4422
72519297|NCT02038790|144567905|SUPERIORITY_OR_OTHER|||||||0.2377|TWO_SIDED||||||Chi-squared|||||||0.2377
72519298|NCT02038790|144567906|SUPERIORITY_OR_OTHER|||||||0.0603|TWO_SIDED||||||Chi-squared|||||||0.0603
72519299|NCT02038790|144567907|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Chi-squared|||||||<0.0010
72519300|NCT00438464|144567935|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<0.001
72519301|NCT00438464|144567936|SUPERIORITY_OR_OTHER|||||||0.003|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.003
72519302|NCT00438464|144567937|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<0.001
72519303|NCT00438464|144567938|SUPERIORITY_OR_OTHER|||||||0.805|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.805
72519304|NCT00438464|144567939|SUPERIORITY_OR_OTHER|||||||0.254|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.254
72519305|NCT00438464|144567940|SUPERIORITY_OR_OTHER|||||||0.7|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||VEGF3, Within GG3||||0.70
72519306|NCT00438464|144567940|SUPERIORITY_OR_OTHER|||||||0.38|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Estrogen receptor beta (ERβ), Within GG3||||0.38
72519307|NCT00438464|144567940|SUPERIORITY_OR_OTHER|||||||0.41|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Androgen receptor (AR), Within GG3||||0.41
72519308|NCT00438464|144567940|SUPERIORITY_OR_OTHER|||||||0.75|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Ki-67 protein, Within GG3||||0.75
72519309|NCT00438464|144567940|SUPERIORITY_OR_OTHER|||||||0.57|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||3-oxo-5α-steroid 4-dehydrogenase 2 (SRD5A2), Within GG3||||0.57
72519310|NCT00438464|144567940|SUPERIORITY_OR_OTHER|||||||0.12|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Ubiquitin-conjugating enzyme E2C (UBE2C), Within GG3||||0.12
72519311|NCT00438464|144567940|SUPERIORITY_OR_OTHER|||||||0.03|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Cleaved Caspase 3 (Caspase), Within GG3||||0.03
72519312|NCT00438464|144567941|SUPERIORITY_OR_OTHER|||||||0.45|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Vascular Epithelial Growth Factor (VEGF3), Within GG4||||0.45
72519313|NCT00438464|144567941|SUPERIORITY_OR_OTHER|||||||0.83|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Estrogen receptor beta (ERβ), Within GG4||||0.83
72519314|NCT00438464|144567941|SUPERIORITY_OR_OTHER|||||||0.04|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Androgen receptor (AR), Within GG4||||0.04
72519315|NCT00438464|144567941|SUPERIORITY_OR_OTHER|||||||0.8|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Ki-67 protein, Within GG4||||0.80
72519316|NCT00438464|144567941|SUPERIORITY_OR_OTHER|||||||0.61|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||3-oxo-5α-steroid 4-dehydrogenase 2 (SRD5A2), Within GG4||||0.61
72519317|NCT00438464|144567941|SUPERIORITY_OR_OTHER|||||||0.86|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||UBE2C, Within GG4||||0.86
72519318|NCT00438464|144567941|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Caspase, Within GG4||||0.02
72519319|NCT00438464|144567946|SUPERIORITY_OR_OTHER|||||||0.84|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||VEGF3, Within Finasteride Arm||||0.84
72519320|NCT00438464|144567946|SUPERIORITY_OR_OTHER|||||||0.36|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||ERβ, Within Finasteride Arm||||0.36
72519321|NCT00438464|144567946|SUPERIORITY_OR_OTHER|||||||0.09|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||AR, Within Finasteride||||0.09
72519322|NCT00438464|144567946|SUPERIORITY_OR_OTHER|||||||0.46|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Ki-67 protein, Within Finasteride Arm||||0.46
72519323|NCT00438464|144567946|SUPERIORITY_OR_OTHER|||||||0.88|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||SRD5A2, Within Finasteride Arm||||0.88
72519324|NCT00438464|144567946|SUPERIORITY_OR_OTHER|||||||0.18|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||UBE2C, Within Finasteride Arm||||0.18
72519325|NCT00438464|144567946|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Caspase, Within Finasteride Arm||||<0.001
72519326|NCT00438464|144567947|SUPERIORITY_OR_OTHER|||||||0.32|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||VEGF3, Within Placebo Arm||||0.32
72519327|NCT00438464|144567947|SUPERIORITY_OR_OTHER|||||||0.83|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||ERβ, Within Placebo Arm||||0.83
72519328|NCT00438464|144567947|SUPERIORITY_OR_OTHER|||||||0.77|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||AR, Within Placebo Arm||||0.77
72519329|NCT00438464|144567947|SUPERIORITY_OR_OTHER|||||||0.87|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Ki-67 protein, Within Placebo Arm||||0.87
72519330|NCT00438464|144567947|SUPERIORITY_OR_OTHER|||||||0.91|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||SRD5A2, Within Placebo Arm||||0.91
72519331|NCT00438464|144567947|SUPERIORITY_OR_OTHER|||||||0.9|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||UBE2C, Within Placebo Arm||||0.90
72519332|NCT00438464|144567947|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Caspase, Within Placebo Arm||||<0.001
72519333|NCT03943446|144567952|SUPERIORITY||Estimated Difference in ER Rate|-0.1|||=|0.59|TWO_SIDED|95.0|-0.44|0.23|||Fisher Exact|||||0.23|-0.44|=0.590
72519334|NCT03943446|144567952|SUPERIORITY||Estimated difference in ERR|-0.01|||=|1|TWO_SIDED|95.0|-0.34|0.31|||Fisher Exact|||||0.31|-0.34|=1.000
72519335|NCT00270998|144567982|NON_INFERIORITY|Logistic regression was used to adjust for randomization stratification variables of incontinence type and incontinence severity. No parameter estimates were reported. No adjustments for multiple comparisons made.|||||<|0.0492||||||A priori threshold for statistical significance set at p = 0.0492 to account for interim analysis|Regression, Logistic|||A priori, the combination treatment was considered superior (75% success rate) to either single-modality therapy (60% success rate) at 80% power with 150 participants per group.||||<0.0492
72519336|NCT00270998|144567982|NON_INFERIORITY|Logistic regression was used to adjust for randomization stratification variables of incontinence type and incontinence severity. No parameter estimates were reported. No adjustments for multiple comparisons made.||||||0.02||||||A priori threshold for statistical significance set at p = 0.0492 to account for interim analysis|Regression, Logistic|||A priori, the combination treatment was considered superior (75% success rate) to either single-modality therapy (60% success rate) at 80% power with 150 participants per group.||||0.02
72519337|NCT00270998|144567982|NON_INFERIORITY|Logistic regression was used to adjust for randomization stratification variables of incontinence type and incontinence severity. No parameter estimates were reported. No adjustments for multiple comparisons made.||||||0.49||||||A priori threshold for statistical significance set at p = 0.0492 to account for interim analysis|Regression, Logistic|||A priori, the combination treatment was considered superior (75% success rate) to either single-modality therapy (60% success rate) at 80% power with 150 participants per group.||||0.49
72519338|NCT00270998|144567983|NON_INFERIORITY|Logistic regression was used to adjust for randomization stratification variables of incontinence type and incontinence severity. No parameter estimates were reported. No adjustments for multiple comparisons made.||||||0.006|||||||Regression, Logistic|||||||0.006
72519339|NCT00270998|144567983|NON_INFERIORITY|Logistic regression was used to adjust for randomization stratification variables of incontinence type and incontinence severity. No parameter estimates were reported. No adjustments for multiple comparisons made.||||||0.048|||||||Regression, Logistic|||||||0.048
72519340|NCT00270998|144567983|NON_INFERIORITY|Logistic regression was used to adjust for randomization stratification variables of incontinence type and incontinence severity. No parameter estimates were reported. No adjustments for multiple comparisons made.||||||0.42|||||||Regression, Logistic|||||||0.42
72519341|NCT00270998|144567984|NON_INFERIORITY|Logistic regression was used to adjust for randomization stratification variables of incontinence type and incontinence severity. No parameter estimates were reported. No adjustments for multiple comparisons made.|||||<|0.0492|||||||Regression, Logistic|||||||<0.0492
72519342|NCT00270998|144567984|NON_INFERIORITY|Logistic regression was used to adjust for randomization stratification variables of incontinence type and incontinence severity. No parameter estimates were reported. No adjustments for multiple comparisons made.|||||<|0.0492|||||||Regression, Logistic|||||||<0.0492
72519343|NCT00270998|144567984|NON_INFERIORITY|Logistic regression was used to adjust for randomization stratification variables of incontinence type and incontinence severity. No parameter estimates were reported. No adjustments for multiple comparisons made.|||||<|0.0492|||||||Regression, Logistic|||||||<0.0492
72519344|NCT00270998|144567985|NON_INFERIORITY|Logistic regression was used to adjust for randomization stratification variables of incontinence type and incontinence severity. No parameter estimates were reported. No adjustments for multiple comparisons made.|||||<|0.0492|||||||Regression, Logistic|||||||<0.0492
72519345|NCT00270998|144567985|NON_INFERIORITY|Logistic regression was used to adjust for randomization stratification variables of incontinence type and incontinence severity. No parameter estimates were reported. No adjustments for multiple comparisons made.|||||<|0.0492|||||||Regression, Logistic|||||||<0.0492
72519346|NCT00270998|144567985|NON_INFERIORITY|Logistic regression was used to adjust for randomization stratification variables of incontinence type and incontinence severity. No parameter estimates were reported. No adjustments for multiple comparisons made.|||||<|0.0492|||||||Regression, Logistic|||||||<0.0492
72569678|NCT02944383|144669985|SUPERIORITY|||||||0.06||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.0600
72519347|NCT00270998|144567986|NON_INFERIORITY|Logistic regression was used to adjust for randomization stratification variables of incontinence type and incontinence severity. No parameter estimates were reported. No adjustments for multiple comparisons made.|||||<|0.0492|||||||Regression, Logistic|||||||<0.0492
72519348|NCT00270998|144567986|NON_INFERIORITY|Logistic regression was used to adjust for randomization stratification variables of incontinence type and incontinence severity. No parameter estimates were reported. No adjustments for multiple comparisons made.|||||<|0.0492|||||||Regression, Logistic|||||||<0.0492
72519349|NCT00270998|144567986|NON_INFERIORITY|Logistic regression was used to adjust for randomization stratification variables of incontinence type and incontinence severity. No parameter estimates were reported. No adjustments for multiple comparisons made.|||||<|0.0492|||||||Regression, Logistic|||||||<0.0492
72519350|NCT00270998|144567987|NON_INFERIORITY|Logistic regression was used to adjust for randomization stratification variables of incontinence type and incontinence severity. No parameter estimates were reported. No adjustments for multiple comparisons made.|||||<|0.0492|||||||Regression, Logistic|||||||<0.0492
72519351|NCT00270998|144567987|NON_INFERIORITY|Logistic regression was used to adjust for randomization stratification variables of incontinence type and incontinence severity. No parameter estimates were reported. No adjustments for multiple comparisons made.|||||<|0.0492|||||||Regression, Logistic|||||||<0.0492
72519352|NCT00270998|144567987|NON_INFERIORITY|Logistic regression was used to adjust for randomization stratification variables of incontinence type and incontinence severity. No parameter estimates were reported. No adjustments for multiple comparisons made.|||||<|0.0492|||||||Regression, Logistic|||||||<0.0492
72519353|NCT00270998|144567988|NON_INFERIORITY|Logistic regression was used to adjust for randomization stratification variables of incontinence type and incontinence severity. No parameter estimates were reported. No adjustments for multiple comparisons made.||||||0.03|||||||Regression, Logistic|||||||0.03
72519354|NCT00270998|144567988|NON_INFERIORITY|Logistic regression was used to adjust for randomization stratification variables of incontinence type and incontinence severity. No parameter estimates were reported. No adjustments for multiple comparisons made.||||||0.048|||||||Regression, Logistic|||||||0.048
72519355|NCT00270998|144567988|NON_INFERIORITY|Logistic regression was used to adjust for randomization stratification variables of incontinence type and incontinence severity. No parameter estimates were reported. No adjustments for multiple comparisons made.|||||<|0.0492|||||||Regression, Logistic|||||||<0.0492
72519356|NCT00270998|144567989|NON_INFERIORITY|Logistic regression was used to adjust for randomization stratification variables of incontinence type and incontinence severity. No parameter estimates were reported. No adjustments for multiple comparisons made.|||||<|0.0492|||||||Regression, Logistic|||||||<0.0492
72519357|NCT00270998|144567989|NON_INFERIORITY|Logistic regression was used to adjust for randomization stratification variables of incontinence type and incontinence severity. No parameter estimates were reported. No adjustments for multiple comparisons made.|||||<|0.0492|||||||Regression, Logistic|||||||<0.0492
72519358|NCT00270998|144567989|NON_INFERIORITY|Logistic regression was used to adjust for randomization stratification variables of incontinence type and incontinence severity. No parameter estimates were reported. No adjustments for multiple comparisons made.|||||<|0.0492|||||||Regression, Logistic|||||||<0.0492
72519359|NCT00763243|144567999|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.22|STANDARD_DEVIATION|2.17||0.766|TWO_SIDED|95.0|-1.44|1.89|||t-test, 2 sided|t(8)=0.31||Change during waiting period (no intervention); no change was hypothesized||1.89|-1.44|0.766
72519360|NCT00763243|144567999|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.67|STANDARD_DEVIATION|1.0|<|0.001|TWO_SIDED|95.0|0.9|2.44|||t-test, 2 sided|t(8)=5.0||Change during the training period||2.44|0.90|<0.001
72519361|NCT00763243|144567999|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.78|STANDARD_DEVIATION|1.86||0.021|TWO_SIDED|95.0|0.35|3.2|||t-test, 2 sided|t(8)=2.87||Change from pre-training through follow-up period||3.20|0.35|0.021
72519362|NCT00763243|144567999|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.33|STANDARD_DEVIATION|1.12||0.4|TWO_SIDED|95.0|-0.53|1.19|||t-test, 2 sided|t(8)=0.89||Change from pretraining to 6 month follow up||1.19|-0.53|0.40
72519363|NCT00763243|144568000|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.33|STANDARD_DEVIATION|2.24||0.11|TWO_SIDED|95.0|-0.39|3.05|||t-test, 2 sided|t(8)=1.79||Change during waiting period of no intervention||3.05|-0.39|0.11
72519364|NCT00763243|144568000|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.44|STANDARD_DEVIATION|1.81||0.004|TWO_SIDED|95.0|1.05|3.84|||t-test, 2 sided|t(8)=4.05||Change during training period||3.84|1.05|0.004
72519365|NCT00763243|144568000|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.11|STANDARD_DEVIATION|3.06||0.072|TWO_SIDED|95.0|-0.24|4.46|||t-test, 2 sided|t(8)=2.07||1 Month Follow Up change from pre-training||4.46|-0.24|0.072
72519366|NCT00763243|144568000|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.78|STANDARD_DEVIATION|2.28||0.34|TWO_SIDED|95.0|-0.97|2.53|||t-test, 2 sided|t(8)=1.02||6 month follow up change from pre-training||2.53|-0.97|0.34
72519367|NCT00763243|144568001|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.22|STANDARD_DEVIATION|1.86||0.729|TWO_SIDED|95.0|-1.2|1.65|||t-test, 2 sided|t(8)=0.36||Waiting period - no treatment||1.65|-1.20|0.729
72519368|NCT00763243|144568001|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.78|STANDARD_DEVIATION|2.17||0.039|TWO_SIDED|95.0|-3.44|-0.11|||t-test, 2 sided|t(8)=2.46||Training Period - Pretraining to Post-Training Visit||-0.11|-3.44|0.039
72569679|NCT02944383|144669985|SUPERIORITY||Median Difference (Net)|0.0||||0.9832|TWO_SIDED|95.0|0.0|0.0||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|EOS (average of week 10 and 12)||0.00|0.00|0.9832
72519369|NCT00763243|144568001|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.89|STANDARD_DEVIATION|2.98||0.4|TWO_SIDED|95.0|-3.17|1.4|||t-test, 2 sided|t(8)=0.90||1 Month Follow Up Period from Pretraining||1.40|-3.17|0.40
72519370|NCT00763243|144568001|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.67|STANDARD_DEVIATION|2.5||0.4|TWO_SIDED|95.0|-2.59|1.26|||t-test, 2 sided|t(8)=0.89||6 Month Follow Up period from pretraining||1.26|-2.59|0.40
72519371|NCT00587834|144568002|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Exact Bionomial Test|||Superiority relative to a pre-defined standard (50% success)||||<0.0001
72519372|NCT00587834|144568003|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||McNemar|||Compare participants with (1) Gintuit equally red and Control not equally red to (2) Gintuit not equally red and Control equally red||||<0.0001
72519373|NCT00587834|144568004|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||McNemar|||Compare participants with (1)Gintuit equally firm and Control not equally firm to (2) Gintuit not equally firm and Control equally firm||||<0.0001
72519374|NCT00587834|144568005|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Exact binomial test|||Superiority relative to a pre-defined threshold (80%) success||||<0.0001
72519375|NCT00587834|144568006|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Exact binomial test|||The proportion of Gintuit as the preferred procedure.||||<0.0001
72519376|NCT00587834|144568007|SUPERIORITY_OR_OTHER|||||||0.3173||95.0|||||McNemar|McNemar's paired comparison test||Compare participants with (1) Gintuit not sensitive and Control sensitive to (2) Gintuit sensitive and Control not sensitive.||||0.3173
72519377|NCT02157168|144568021|SUPERIORITY|||||||0.624||||||This comparison reflects intent to treat and is the main comparison in the study.|Chi-squared|||CG and IG (IG1+IG2)||||0.624
72519378|NCT02157168|144568021|SUPERIORITY|||||||0.001||||||This comparison could be considered to be a per protocol analysis. Note, however, that the IG1 group was self-selected.|Chi-squared|||||||0.001
72519379|NCT02157168|144568022|SUPERIORITY|||||||0.278||||||This comparison reflects intent to treat and compares the two randomized groups CG and IG (IG1+IG2).|Chi-squared|||CG and IG (IG1+IG2)||||0.278
72519380|NCT02157168|144568022|SUPERIORITY|||||||0.056||||||This comparison could be considered to be a per protocol analysis. Note, however, that the IG1 group was self-selected.|Chi-squared|||||||0.056
72519381|NCT02157168|144568023|SUPERIORITY|||||||0.889||||||This comparison reflects intent to treat and compares the two randomized groups CG and IG (IG1+IG2).|Chi-squared|||CG and IG (IG1+IG2)||||0.889
72519382|NCT02157168|144568023|SUPERIORITY|||||||0.691||||||This comparison could be considered to be a per protocol analysis. Note, however, that the IG1 group was self-selected.|Chi-squared|||||||0.691
72519383|NCT02157168|144568024|SUPERIORITY|||||||0.741||||||This comparison reflects intent to treat and compares the two randomized groups CG and IG (IG1+IG2).|Chi-squared|||CG and IG (IG1+IG2)||||0.741
72519384|NCT02157168|144568024|SUPERIORITY|||||||0.966||||||This comparison could be considered to be a per protocol analysis. Note, however, that the IG1 group was self-selected.|Chi-squared|||||||0.966
72519385|NCT02157168|144568025|SUPERIORITY|||||||0.117||||||This comparison captures the change over the intervention period.|Chi-squared|||||||.117
72519386|NCT02157168|144568025|SUPERIORITY|||||||0.638||||||This comparison is an indication of whether the change seen between baseline and 6 months in the IG1 was due to the intervention or simply due to 6 months' enrollment.|Chi-squared|||||||.638
72569680|NCT02944383|144669985|SUPERIORITY||Median Difference (Net)|0.0||||0.1352|TWO_SIDED|95.0|0.0|0.0||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|EOS (average of week 10 and 12)||0.00|0.00|0.1352
72569681|NCT02944383|144669986|SUPERIORITY|||||||0.2857||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|ranked ANCOVA|||Week 10||||0.2857
72569682|NCT02944383|144669986|SUPERIORITY|||||||0.4486||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.4486
72569683|NCT02944383|144669986|SUPERIORITY|||||||0.764||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.7640
72569684|NCT02944383|144669986|SUPERIORITY|||||||0.056||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.0560
72569685|NCT02944383|144669986|SUPERIORITY|||||||0.9954||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||EOS (average of week 10 and 12)||||0.9954
72569686|NCT02944383|144669986|SUPERIORITY|||||||0.1298||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||EOS (average of week 10 and 12)||||0.1298
72569687|NCT02944383|144669987|SUPERIORITY|||||||0.0161||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate|Ranked ANCOVA|||Week 10||||0.0161
72569688|NCT02944383|144669987|SUPERIORITY|||||||0.1806||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate|Ranked ANCOVA|||Week 10||||0.1806
72519387|NCT00425100|144568026|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.0|STANDARD_DEVIATION|3.1|<|0.0001||95.0|-3.2|-2.7||All paired t-tests were performed with a two-sided test at significance level of 5%. Efficacy was claimed only when all 3 primary diary endpoints demonstrated statistical significance in change from baseline to Week 12.|2-sided paired t-test|paired t-test comparing baseline with post-baseline values||Open-label study with statistical comparison between baseline and Week 12. Null hypothesis: The mean change from baseline in number of micturition episodes per 24 hours at Week 12 is equal to 0. The sample size was based on a statistical power for each of the three individual diary endpoints of .95 which would yield an overall power of 85%.||-2.7|-3.2|<0.0001
72519388|NCT00425100|144568027|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.7|STANDARD_DEVIATION|2.4|<|0.0001||95.0|-2.0|-1.4||All paired t-tests were performed with a two-sided test at significance level of 5%. Efficacy was claimed only when all 3 primary diary endpoints demonstrated statistical significance in change from baseline to Week 12.|2-sided paired t-test|paired t-test comparing baseline with post-baseline values||Open-label study with statistical comparison between baseline and Week 12. Null hypothesis: The mean change from baseline in number of urgency urinary incontinence per 24 hours is equal to 0. The sample size was based on a statistical power for each of the three individual diary endpoints of .95 which would yield an overall power of 85%.||-1.4|-2.0|<0.0001
72519389|NCT00425100|144568028|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.0|STANDARD_DEVIATION|4.8|<|0.0001||95.0|-5.4|-4.5||All paired t-tests were performed with a two-sided test at significance level of 5%. Efficacy was claimed only when all 3 primary diary endpoints demonstrated statistical significance in change from baseline to Week 12.|2-sided paired t-test|paired t-test comparing baseline with post-baseline values||Open-label study with statistical comparison between baseline and Week 12. Null hypothesis: The mean change from baseline in number of urgency episodes per 24 hours is equal to 0. The sample size was based on a statistical power for each of the three individual diary endpoints of .95 which would yield an overall power of 85%.||-4.5|-5.4|<0.0001
72519390|NCT00425100|144568030|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.8|STANDARD_DEVIATION|1.2|<|0.0001||||||P-value was not adjusted for multiple comparisons. All paired t-tests were performed with a two-sided test at significance level of 5%.|2 sided paired t-test|||This is an open-label study with statistical comparison between baseline and Week 12.||||<0.0001
72519391|NCT00425100|144568031|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.5|STANDARD_DEVIATION|4.1|<|0.0001||||||P-value was not adjusted for multiple comparisons. All paired t-tests were performed with a two-sided test at significance level of 5%.|2-sided paired t-test|||This is an open-label study with statistical comparison between baseline and Week 12.||||<0.0001
72519392|NCT00425100|144568032|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.7|STANDARD_DEVIATION|0.7|<|0.0001||||||P-value was not adjusted for multiple comparisons. All paired t-tests were performed with a two-sided test at significance level of 5%.|2-sided paired t-test|||This is an open-label study with statistical comparison between baseline and Week 12.||||<0.0001
72519393|NCT00425100|144568033|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.8|STANDARD_DEVIATION|1.3|<|0.0001||||||P-value was not adjusted for multiple comparisons. All paired t-tests were performed with a two-sided test at significance level of 5%.|2-sided paired t-test|||This is an open-label study with statistical comparison between baseline and Week 12.||||<0.0001
72519394|NCT00425100|144568035|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.5|STANDARD_DEVIATION|0.7|<|0.0001||||||P-value was not adjusted for multiple comparisons. All paired t-tests were performed with a two-sided test at significance level of 5%.|2-sided paired t-test|||This is an open-label study with statistical comparison between baseline and Week 12.||||<0.0001
72519395|NCT00425100|144568037|SUPERIORITY_OR_OTHER||Mean Difference (Net)|28.6|STANDARD_DEVIATION|26.4|<|0.0001||||||P-value was not adjusted for multiple comparisons. All paired t-tests were performed with a two-sided test at significance level of 5%.|2-sided paired t-test|||This is an open-label study with statistical comparison between baseline and Week 12.||||<0.0001
72519396|NCT00425100|144568038|SUPERIORITY_OR_OTHER||Mean Difference (Net)|30.6|STANDARD_DEVIATION|26.6|<|0.0001||||||P-value was not adjusted for multiple comparisons. All paired t-tests were performed with a two-sided test at significance level of 5%.|2-sided paired t-test|||This is an open-label study with statistical comparison between baseline and Week 12.||||<0.0001
72519397|NCT00425100|144568039|SUPERIORITY_OR_OTHER||Mean Difference (Net)|24.9|STANDARD_DEVIATION|27.3|<|0.0001||||||P-value was not adjusted for multiple comparisons. All paired t-tests were performed with a two-sided test at significance level of 5%.|2-sided paired t-test|||This is an open-label study with statistical comparison between baseline and Week 12.||||<0.0001
72519398|NCT00425100|144568040|SUPERIORITY_OR_OTHER||Mean Difference (Net)|16.8|STANDARD_DEVIATION|21.1|<|0.0001||||||P-value was not adjusted for multiple comparisons. All paired t-tests were performed with a two-sided test at significance level of 5%.|2-sided paired t-test|||This is an open-label study with statistical comparison between baseline and Week 12.||||<0.0001
72519399|NCT00425100|144568041|SUPERIORITY_OR_OTHER||Mean Difference (Net)|26.1|STANDARD_DEVIATION|22.8|<|0.0001||||||P-value was not adjusted for multiple comparisons. All paired t-tests were performed with a two-sided test at significance level of 5%.|2-sided paired t-test|||This is an open-label study with statistical comparison between baseline and Week 12.||||<0.0001
72519400|NCT00425100|144568042|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-28.7|STANDARD_DEVIATION|22.7|<|0.0001||||||P-value was not adjusted for multiple comparisons. All paired t-tests were performed with a two-sided test at significance level of 5%.|2-sided paired t-test|||This is an open-label study with statistical comparison between baseline and Week 12.||||<0.0001
72519401|NCT00425100|144568044|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-15.2|STANDARD_DEVIATION|14.2|<|0.0001||||||P-value was not adjusted for multiple comparisons. All paired t-tests were performed with a two-sided test at significance level of 5%.|2-sided paired t-test|||This is an open-label study with statistical comparison between baseline and Week 12.||||<0.0001
72519402|NCT03162458|144568070|SUPERIORITY|||||||0.007|||||||Wilcoxon (Mann-Whitney)|||||||0.007
72519403|NCT03162458|144568071|SUPERIORITY|||||||0.0004|||||||Wilcoxon (Mann-Whitney)|||||||0.0004
72519404|NCT03162458|144568072|SUPERIORITY|||||||0.055|||||||Log Rank|||||||0.055
72519405|NCT03162458|144568073|SUPERIORITY|||||||0.051|||||||Wilcoxon (Mann-Whitney)|||||||0.051
72519406|NCT03162458|144568074|SUPERIORITY|||||||0.19|||||||ANOVA|||Mean body temperatures, measured in the morning on Days 2-5 (based on patient diary data)||||0.19
72519407|NCT03162458|144568074|SUPERIORITY|||||||0.44|||||||ANOVA|||Mean body temperatures, measured in the evening on Days 2-5 (based on patient diary data)||||0.44
72519408|NCT03162458|144568075|SUPERIORITY|||||||0.15|||||||Log Rank|||||||0.15
72519409|NCT03162458|144568076|SUPERIORITY|||||||0.004|||||||ANOVA|||||||0.004
72519410|NCT03162458|144568077|SUPERIORITY|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||||||0.001
72519411|NCT03162458|144568078|SUPERIORITY|||||||0.63|||||||ANOVA|||||||0.63
72519412|NCT03162458|144568079|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.0
72519413|NCT00788697|144568082|SUPERIORITY_OR_OTHER||Difference in Sensitivity (%)|11.3||||0.0754|TWO_SIDED|95.0|-1.0|23.6|||McNemar|||||23.6|-1.0|0.0754
72519414|NCT00788697|144568082|SUPERIORITY_OR_OTHER||Difference in Sensitivity (%)|19.4||||0.0011|TWO_SIDED|95.0|8.3|30.5|||McNemar|||||30.5|8.3|0.0011
72519415|NCT00788697|144568082|SUPERIORITY_OR_OTHER||Difference in Sensitivity (%)|-19.4||||0.0016|TWO_SIDED|95.0|-30.9|-7.8|||McNemar|||||-7.8|-30.9|0.0016
72519416|NCT00788697|144568083|SUPERIORITY_OR_OTHER||Difference in Specificity (%)|47.4|||<|0.0001|TWO_SIDED|95.0|37.4|57.4|||McNemar|||||57.4|37.4|<.0001
72519417|NCT00788697|144568083|SUPERIORITY_OR_OTHER||Difference in Specificity (%)|60.3|||<|0.0001|TWO_SIDED|95.0|50.5|70.2|||McNemar|||||70.2|50.5|<.0001
72519418|NCT00788697|144568083|SUPERIORITY_OR_OTHER||Difference in Specificity (%)|29.3|||<|0.0001|TWO_SIDED|95.0|19.7|38.9|||McNemar|||||38.9|19.7|<.0001
72519419|NCT00788697|144568084|SUPERIORITY_OR_OTHER||Difference in Accuracy (%)|28.8|||<|0.0001|TWO_SIDED|95.0|20.5|37.0|||McNemar|||||37.0|20.5|<.0001
72519420|NCT00788697|144568084|SUPERIORITY_OR_OTHER||Difference in Accuracy (%)|39.2|||<|0.0001|TWO_SIDED|95.0|31.3|47.1|||McNemar|||||47.1|31.3|<.0001
72519421|NCT00788697|144568084|SUPERIORITY_OR_OTHER||Difference in Accuracy (%)|4.2||||0.3173|TWO_SIDED|95.0|-4.0|12.3|||McNemar|||||12.3|-4.0|0.3173
72519422|NCT00788697|144568085|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wald Test|||||||<.0001
72519423|NCT00788697|144568085|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wald Test|||||||<.0001
72519424|NCT00788697|144568085|SUPERIORITY_OR_OTHER|||||||0.0004|||||||Wald Test|||||||0.0004
72519425|NCT00788697|144568086|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wald Test|||||||<.0001
72519426|NCT00788697|144568086|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wald Test|||||||<.0001
72519427|NCT00788697|144568086|SUPERIORITY_OR_OTHER|||||||0.761|||||||Wald Test|||||||0.7610
72519428|NCT01412060|144568112|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.45||||0.001|TWO_SIDED|95.0|0.28|0.73|||Log Rank||Hazard ratio (cariprazine 3-9 mg vs placebo) is based on Cox proportional hazards regression model, with treatment group as an explanatory variable.|||0.73|0.28|0.0010
72519429|NCT00004732|144568118|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.11|||||TWO_SIDED|95.0|0.81|1.51|||||HR (95% CI) adjusted for age, sex and symptomatic status|||1.51|0.81|
72519430|NCT00004732|144568119|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.35|||||TWO_SIDED|95.0|0.82|2.23|||||HR (95% CI) for WOMEN CAS vs CEA (adjusted for age and symptomatic status)|||2.23|0.82|
72624906|NCT04716894|144779372|OTHER||adjusted geometric mean (gMean) ratio(%)|143.38|||||TWO_SIDED|90.0|121.92|168.6|||||Ratio (%) = T/R\*100. Intra-individual geometric coefficient of variation (gCV) = 22.1.|Relative bioavailability. Model used was an analysis of variance (ANOVA) model on the logarithmic scale. Data were log-transformed (natural logarithm) prior to fitting the ANOVA model. The effect 'subjects' was considered as random effect, whereas 'treatment' was considered as fixed effect.||168.60|121.92|
72624907|NCT04716894|144779373|OTHER||adjusted geometric mean (gMean) ratio(%)|201.64|||||TWO_SIDED|90.0|192.23|211.52|||||Ratio (%) = T/R\*100. Intra-individual geometric coefficient of variation (gCV) = 6.5.|Relative bioavailability. Model used was an analysis of variance (ANOVA) model on the logarithmic scale. Data were log-transformed (natural logarithm) prior to fitting the ANOVA model. The effect 'subjects' was considered as random effect, whereas 'treatment' was considered as fixed effect.||211.52|192.23|
72624908|NCT03126630|144779376|EQUIVALENCE|The null hypothesis that there are no differences between the classes in the population. The purpose of the test is to evaluate how likely the observed frequencies would be assuming the null hypothesis is true.||||||0.27541|||||||Chi-squared|||||||0.27541
72624909|NCT03126630|144779379|SUPERIORITY||Hazard Ratio (HR)|0.0||||0.1936|TWO_SIDED|95.0|0.0||Not enough events||Log Rank||||||0.0|0.1936
72624910|NCT03126630|144779380|SUPERIORITY||Hazard Ratio (HR)|1.81||||0.1952|TWO_SIDED|95.0|0.73|4.51|||Log Rank|||||4.51|0.73|0.1952
72519431|NCT01183312|144568120|SUPERIORITY_OR_OTHER|||||||0.77||95.0|||||wilcoxon signed rank (paired)|||||||0.77
72624911|NCT02496000|144779396|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0117|||||||Kruskal-Wallis|ANOVA model on the ranks||This outcome measure requires that the the mean differences of ORMD-0801 in each of the two arms be pooled.||||0.0117
72624912|NCT01877278|144779427|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||t-test, 2 sided|||||||<0.0001
72624913|NCT01877278|144779427|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||t-test, 2 sided|||||||>0.05
72624914|NCT01877278|144779428|SUPERIORITY_OR_OTHER||||||=|0.0001|TWO_SIDED||||||t-test, 2 sided|||||||=0.0001
72624915|NCT01877278|144779428|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||t-test, 2 sided|||||||>0.05
72624916|NCT02757768|144779441|SUPERIORITY||Least Squares (LS) Mean of Difference|-0.39|STANDARD_ERROR_OF_MEAN|0.19||0.039|TWO_SIDED|95.0|-0.76|-0.02|||ANCOVA|||Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||-0.02|-0.76|0.039
72624917|NCT02757768|144779442|SUPERIORITY||LS Mean of Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.18||0.558|TWO_SIDED|95.0|-0.46|0.25|||ANCOVA|||Week 4 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||0.25|-0.46|0.558
72519432|NCT01183312|144568121|SUPERIORITY_OR_OTHER|||||||0.51||95.0|||||Wilcoxon Signed Rank (paired)|||||||0.51
72519433|NCT01183312|144568122|SUPERIORITY_OR_OTHER|||||||0.32||95.0|||||Wilcoxon Signed Rank (paired)|||||||0.32
72519434|NCT01183312|144568123|SUPERIORITY_OR_OTHER|||||||0.56||95.0|||||Wilcoxon Signed Rank (paired)|||||||0.56
72519435|NCT01183312|144568124|SUPERIORITY_OR_OTHER|||||||0.14||95.0|||||Wilcoxon Signed Rank (paired)|||||||0.14
72519436|NCT01183312|144568125|SUPERIORITY_OR_OTHER|||||||0.89||95.0|||||Wilcoxon Signed Rank (paired)|||||||0.89
72519437|NCT01183312|144568126|SUPERIORITY_OR_OTHER|||||||0.13||95.0|||||Wilcoxon Signed Rank (paired)|||||||0.13
72519438|NCT01569087|144568184|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Fisher Exact|||||||<0.05
72519439|NCT03404219|144568258|OTHER|Single group pre-post, follow-up|Mean Difference (Final Values)|2.56||||0.09|TWO_SIDED||||||General Linear Model (repeated measures)|||Single arm||||0.09
72519440|NCT00607919|144568274|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Mixed Models Analysis|||||||<0.001
72519441|NCT00527072|144568376|SUPERIORITY_OR_OTHER||Proportion|0.654||||0.05|TWO_SIDED|95.0|0.586|0.718|||exact binomial distribution|||null hypothesis H0: proportion = 0.30||0.718|0.586|0.05
72519442|NCT00527072|144568377|SUPERIORITY_OR_OTHER||proportion|0.791||||0.05|TWO_SIDED|95.0|0.73|0.844|||exact binomial distribution|||||0.844|0.730|0.05
72519443|NCT00527072|144568378|SUPERIORITY_OR_OTHER||proportion|0.646||||0.05|TWO_SIDED|95.0|0.577|0.711|||exact binomial distribution|||||0.711|0.577|0.05
72519444|NCT02007252|144568379|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.1037|||||||ANCOVA|||Month 3||||= 0.1037
72519445|NCT02007252|144568379|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.4806|||||||ANCOVA|||Month 12||||= 0.4806
72519446|NCT02001688|144568380|SUPERIORITY|||||||0.0005||||||One-sided test was used for antigenic and functional AAT levels to maintain overall 2.5% level of significance|Wilcoxon (Mann-Whitney)|||||||0.0005
72519447|NCT02001688|144568380|SUPERIORITY|||||||0.02|||||||Wilcoxon (Mann-Whitney)|One-sided test was used for antigenic and functional AAT levels to maintain overall 2.5% level of significance||||||0.020
72519448|NCT02001688|144568380|SUPERIORITY|||||||0.0192|||||||Wilcoxon (Mann-Whitney)|One-sided test was used for antigenic and functional AAT levels to maintain overall 2.5% level of significance||||||0.0192
72519449|NCT02001688|144568381|SUPERIORITY|||||||0.0005||||||One-sided test was used for antigenic and functional AAT levels to maintain overall 2.5% level of significance|Wilcoxon (Mann-Whitney)|p-value of Stratified Wilcoxon test||||||0.0005
72519450|NCT02001688|144568381|SUPERIORITY|||||||0.0193|||||||Wilcoxon (Mann-Whitney)|One-sided test was used for antigenic and functional AAT levels to maintain overall 2.5% level of significance||||||0.0193
72519451|NCT02001688|144568381|SUPERIORITY|||||||0.2485|||||||Wilcoxon (Mann-Whitney)|One-sided test was used for antigenic and functional AAT levels to maintain overall 2.5% level of significance||||||0.2485
72519452|NCT02001688|144568382|SUPERIORITY||||||<|0.0001|||||||Kruskal-Wallis|p-value of Kruskal-Wallis test (3 groups: Kamada-AAT for Inhalation, 80mg,Kamada-AAT for Inhalation, 160mg and placebo)||||||<0.0001
72519453|NCT02001688|144568383|SUPERIORITY||||||<|0.0001|||||||Kruskal-Wallis|p-value of Kruskal-Wallis test (3 groups: Kamada-AAT for Inhalation, 80mg, Kamada-AAT for Inhalation, 160mg and placebo)||||||<0.0001
72519454|NCT00813917|144568384|SUPERIORITY_OR_OTHER|||||||0.126||95.0||||For this randomized phase II we used a one sided test with a false positive(type I error)rate of 0.20 to assess whether additional studies of the experimental arm are warranted.|Chi-squared|1 sided||Data were compared between treatment groups using Chi Square test.||||0.126
72519455|NCT05441540|144568385|OTHER||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
72519456|NCT05441540|144568386|OTHER||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
72519457|NCT05441540|144568387|OTHER|||||||0.7613|||||||Kruskal-Wallis|||||||0.7613
72519458|NCT05441540|144568388|OTHER|||||||0.764|||||||Wilcoxon (Mann-Whitney)|||||||0.7640
72519459|NCT00792701|144568401|OTHER|Correlation|Correlation Coefficient|0.39||||0.003|TWO_SIDED||||||t-test, 2 sided|||||||0.003
72519460|NCT00792701|144568404|SUPERIORITY_OR_OTHER_LEGACY||Correlation Coefficient|0.39||||0.0003|TWO_SIDED||||||Chi-squared|||Comparing RRM1 levels and ERCC1 levels between all patients.||||.0003
72519461|NCT00563368|144568448|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.76|STANDARD_ERROR_OF_MEAN|0.831||0.0009|TWO_SIDED|95.0|1.13|4.39||Intersection-union method applied in a step-down testing approach|ANCOVA|||With 100 subjects in each of the seven arms in this trial, the trial has more than 90% power to detect a difference of at least 3.1% between combination and monotherapy or placebo treatment assuming a standard deviation of 5.3% and a significance level of 0.05.||4.39|1.13|0.0009
72519462|NCT00563368|144568448|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.15|STANDARD_ERROR_OF_MEAN|0.825||0.0001|TWO_SIDED|95.0|1.53|4.77||Intersection-union method applied in a step-down testing approach|ANCOVA|||With 100 subjects in each of the seven arms in this trial, the trial has more than 90% power to detect a difference of at least 3.1% between combination and monotherapy or placebo treatment assuming a standard deviation of 5.3% and a significance level of 0.05.||4.77|1.53|0.0001
72519463|NCT00563368|144568448|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.49|STANDARD_ERROR_OF_MEAN|0.83|<|0.0001|TWO_SIDED|95.0|5.86|9.12||Intersection-union method applied in a step-down testing approach|ANCOVA|||With 100 subjects in each of the seven arms in this trial, the trial has more than 90% power to detect a difference of at least 3.1% between combination and monotherapy or placebo treatment assuming a standard deviation of 5.3% and a significance level of 0.05.||9.12|5.86|<0.0001
72519464|NCT00563368|144568448|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.33|STANDARD_ERROR_OF_MEAN|0.832|<|0.0001|TWO_SIDED|95.0|1.69|4.96||Intersection-union method applied in a step-down testing approach|ANCOVA|||With 100 subjects in each of the seven arms in this trial, the trial has more than 90% power to detect a difference of at least 3.1% between combination and monotherapy or placebo treatment assuming a standard deviation of 5.3% and a significance level of 0.05.||4.96|1.69|<0.0001
72519465|NCT00563368|144568448|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.01|STANDARD_ERROR_OF_MEAN|0.828||0.0003|TWO_SIDED|95.0|1.38|4.63||Intersection-union method applied in a step-down testing approach|ANCOVA|||With 100 subjects in each of the seven arms in this trial, the trial has more than 90% power to detect a difference of at least 3.1% between combination and monotherapy or placebo treatment assuming a standard deviation of 5.3% and a significance level of 0.05.||4.63|1.38|0.0003
72519466|NCT00563368|144568448|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.75|STANDARD_ERROR_OF_MEAN|0.831|<|0.0001|TWO_SIDED|95.0|5.11|8.38||Intersection-union method applied in a step-down testing approach|ANCOVA|||With 100 subjects in each of the seven arms in this trial, the trial has more than 90% power to detect a difference of at least 3.1% between combination and monotherapy or placebo treatment assuming a standard deviation of 5.3% and a significance level of 0.05.||8.38|5.11|<0.0001
72519467|NCT00563368|144568449|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.028|STANDARD_ERROR_OF_MEAN|0.5832||0.014|TWO_SIDED|95.0|1.154|3.563||Intersection-union method applied in a step-down testing approach|Regression, Logistic|||With 100 subjects in each of the seven arms in this trial, the trial has more than 90% power to detect a difference of at least 3.1% between combination and monotherapy or placebo treatment assuming a standard deviation of 5.3% and a significance level of 0.05.||3.563|1.154|0.0140
72519468|NCT00563368|144568449|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.246|STANDARD_ERROR_OF_MEAN|0.6418||0.0046|TWO_SIDED|95.0|1.283|3.932||Intersection-union method applied in a step-down testing approach|Regression, Logistic|||With 100 subjects in each of the seven arms in this trial, the trial has more than 90% power to detect a difference of at least 3.1% between combination and monotherapy or placebo treatment assuming a standard deviation of 5.3% and a significance level of 0.05.||3.932|1.283|0.0046
72519469|NCT00563368|144568449|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|10.623|STANDARD_ERROR_OF_MEAN|3.644|<|0.0001|TWO_SIDED|95.0|5.424|20.81||Intersection-union method applied in a step-down testing approach|Regression, Logistic|||With 100 subjects in each of the seven arms in this trial, the trial has more than 90% power to detect a difference of at least 3.1% between combination and monotherapy or placebo treatment assuming a standard deviation of 5.3% and a significance level of 0.05.||20.81|5.424|<0.0001
72519470|NCT00563368|144568449|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.568|STANDARD_ERROR_OF_MEAN|0.7391||0.0011|TWO_SIDED|95.0|1.46|4.514||Intersection-union method applied in a step-down testing approach|Regression, Logistic|||With 100 subjects in each of the seven arms in this trial, the trial has more than 90% power to detect a difference of at least 3.1% between combination and monotherapy or placebo treatment assuming a standard deviation of 5.3% and a significance level of 0.05.||4.514|1.460|0.0011
72519471|NCT00563368|144568449|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.166|STANDARD_ERROR_OF_MEAN|0.6158||0.0066|TWO_SIDED|95.0|1.241|3.781||Intersection-union method applied in a step-down testing approach|Regression, Logistic|||With 100 subjects in each of the seven arms in this trial, the trial has more than 90% power to detect a difference of at least 3.1% between combination and monotherapy or placebo treatment assuming a standard deviation of 5.3% and a significance level of 0.05.||3.781|1.241|0.0066
72624918|NCT02757768|144779442|SUPERIORITY||LS Mean of Difference|-0.52|STANDARD_ERROR_OF_MEAN|0.19||0.007|TWO_SIDED|95.0|-0.89|-0.14|||ANCOVA|||Week 8 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||-0.14|-0.89|0.007
72405590|NCT01481116|144319407|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-1.44|STANDARD_ERROR_OF_MEAN|0.678||0.034|TWO_SIDED|95.0|-2.78|-0.11||The testing procedure at 2-sided significance level of 0.025 was as follows: 1) TAK-875 25 mg vs. glimepiride, 2) TAK-875 50 mg plus metformin vs. glimepiride. If P-value was not greater than 0.025 at Step 1, then Step 2 was carried out.|Mixed Model Repeated Measures|Treatment, schedule and visit-by-treatment interaction as fixed factors and with baseline value and baseline value by visit interaction as covariates.||Change at Week 78||-0.11|-2.78|0.034
72405591|NCT02365636|144319435|SUPERIORITY||LSM difference from placebo|0.32||||0.13|TWO_SIDED|95.0|-0.094|0.726||5% level of significance|mixed model for repeated measures|||The Mixed Model Repeated Measures (MMRM) model with change from baseline in the weekly average of the daily average NRS scores at week 4 as the dependent variable; week, pooled study center, treatment, and treatment by visit interaction as fixed factors, baseline weekly average of the daily average NRS scores as covariate; and patient as a random effect.||0.726|-0.094|0.130
72405592|NCT02365636|144319435|SUPERIORITY||LSM difference from placebo|0.24||||0.245|TWO_SIDED|95.0|-0.167|0.652||5% level of significance|mixed model for repeated measures|||The Mixed Model Repeated Measures (MMRM) model with change from baseline in the weekly average of the daily average NRS scores at week 4 as the dependent variable; week, pooled study center, treatment, and treatment by visit interaction as fixed factors, baseline weekly average of the daily average NRS scores as covariate; and patient as a random effect.||0.652|-0.167|0.245
72405593|NCT02365636|144319436|SUPERIORITY||LSM difference from placebo|0.32||||0.128|TWO_SIDED|95.0|-0.093|0.735||5% level of significance|mixed model for repeated measures|||The Mixed Model Repeated Measures (MMRM) model with change from baseline in the weekly average of the average NRS pain scores recorded in the evening at week 4 as the dependent variable; week, pooled study center, treatment, and treatment by visit interaction as fixed factors, baseline weekly average of the average NRS pain scores recorded in the evening as covariate; and patient as a random effect.||0.735|-0.093|0.128
72519472|NCT00563368|144568449|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|9.063|STANDARD_ERROR_OF_MEAN|3.0857|<|0.0001|TWO_SIDED|95.0|4.65|17.66||Intersection-union method applied in a step-down testing approach|Regression, Logistic|||With 100 subjects in each of the seven arms in this trial, the trial has more than 90% power to detect a difference of at least 3.1% between combination and monotherapy or placebo treatment assuming a standard deviation of 5.3% and a significance level of 0.05.||17.66|4.650|<0.0001
72519473|NCT01819506|144568450|SUPERIORITY|||||||0.912|||||||ANOVA|||||||0.912
72624919|NCT02757768|144779442|SUPERIORITY||LS Mean of Difference|-0.39|STANDARD_ERROR_OF_MEAN|0.19||0.041|TWO_SIDED|95.0|-0.76|-0.02|||ANCOVA|||Week 12 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||-0.02|-0.76|0.041
72624920|NCT02757768|144779443|SUPERIORITY||LS Mean of Difference|3.87|STANDARD_ERROR_OF_MEAN|2.8||0.167|TWO_SIDED|95.0|-1.63|9.37|||ANCOVA|||Week 4 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||9.37|-1.63|0.167
72405594|NCT02365636|144319436|SUPERIORITY||LSM difference from placebo|0.27||||0.194|TWO_SIDED|95.0|-0.14|0.688||5% level of significance|mixed model for repeated measures|||The Mixed Model Repeated Measures (MMRM) model with change from baseline in the weekly average of the average NRS pain scores recorded in the evening at week 4 as the dependent variable; week, pooled study center, treatment, and treatment by visit interaction as fixed factors, baseline weekly average of the average NRS pain scores recorded in the evening as covariate; and patient as a random effect.||0.688|-0.140|0.194
72405595|NCT02365636|144319437|SUPERIORITY||LSM difference from placebo|0.28||||0.177|TWO_SIDED|95.0|-0.128|0.691||5% level of significance|mixed model for repeated measures|||The Mixed Model Repeated Measures (MMRM) model with change from baseline in the weekly average of the average NRS pain scores recorded in the morning at week 4 as the dependent variable; week, pooled study center, treatment, and treatment by visit interaction as fixed factors, baseline weekly average of the average NRS pain scores recorded in the morning as covariate; and patient as a random effect.||0.691|-0.128|0.177
72405596|NCT02365636|144319437|SUPERIORITY||LSM difference from placebo|0.2||||0.325|TWO_SIDED|95.0|-0.204|0.614||5% level of significance|mixed model for repeated measures|||The Mixed Model Repeated Measures (MMRM) model with change from baseline in the weekly average of the average NRS pain scores recorded in the morning at week 4 as the dependent variable; week, pooled study center, treatment, and treatment by visit interaction as fixed factors, baseline weekly average of the average NRS pain scores recorded in the morning as covariate; and patient as a random effect.||0.614|-0.204|0.325
72519474|NCT00879437|144568453|NON_INFERIORITY|if 19 evaluable patients enrolled for DIPG, study is powered at 80% to detect a 20% improvement in 1-year EFS compared to historical control if 21 evaluable patients enrolled for HGG, study is powered at 80% to detect a 20% improvement in 1-year EFS compared to historical control|||||<|0.05|||||||Log Rank|one sample log-rank||comparing 1-year EFS of DIPG on this trial versus historical control (1-year EFS of 17% from CCG-9941; PMID 12177103) comparing 1-year EFS of HGG on this trial versus historical control (1-year EFS of 36% from ACNS0126; PMID 21339192)||||< 0.05
72519475|NCT00879437|144568493|OTHER|The Kaplan-Meier method was used to estimate the median EFS for each cohort with 95% confidence intervals. All analyses were performed in SAS version 9.4 statistical software (SAS Institute Inc) and R (https://cran.r-project.org/).|||||||TWO_SIDED|95.0|||||||||The Kaplan-Meier method was used to estimate the median EFS for each cohort with 95% confidence intervals.|||
72624921|NCT02757768|144779443|SUPERIORITY||LS Mean of Difference|6.29|STANDARD_ERROR_OF_MEAN|3.28||0.056|TWO_SIDED|95.0|-0.15|12.73|||ANCOVA|||Week 8 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||12.73|-0.15|0.056
72519476|NCT00879437|144568494|OTHER|The Kaplan-Meier method was used to estimate the one-year EFS for each cohort with 95% confidence intervals. All analyses were performed in SAS version 9.4 statistical software (SAS Institute Inc) and R (https://cran.r-project.org/).|||||||TWO_SIDED|95.0|||||||||The Kaplan-Meier method was used to estimate the one-year EFS for each cohort with 95% confidence intervals.|||
72519477|NCT00879437|144568495|OTHER|||||||||||||||||partial response defined as 51% to 99% reduction in tumor size,determined using WHO bi-dimensional criteria (product of the greatest tumor diameter and its perpendicular diameter)|Not applicable (8 partial responses in 16 patients = 50%)|||
72519478|NCT03000686|144568498|OTHER||Median Difference (Net)|0.021|STANDARD_DEVIATION|1.1339|||TWO_SIDED|95.0|-2.249|2.295|||||Posterior median difference (GSK2586881 0.8 mg/kg - Placebo) and 95% credible interval is presented for 15 minutes post-infusion|||2.295|-2.249|
72519479|NCT03000686|144568498|OTHER||Median Difference (Net)|-4.021|STANDARD_DEVIATION|2.5923|||TWO_SIDED|95.0|-9.168|1.146|||||Posterior median difference (GSK2586881 0.8 mg/kg - Placebo) and 95% credible interval is presented for 60 minutes post-chamber entry.|||1.146|-9.168|
72519480|NCT03000686|144568498|OTHER||Median Difference (Net)|-1.668|STANDARD_DEVIATION|4.4927|||TWO_SIDED|95.0|-10.576|7.231|||||Posterior median difference (GSK2586881 0.8 mg/kg - Placebo) and 95% credible interval is presented for immediately post-exercise|||7.231|-10.576|
72519481|NCT03000686|144568498|OTHER||Median Difference (Net)|-0.824|STANDARD_DEVIATION|1.6695|||TWO_SIDED|95.0|-4.142|2.506|||||Posterior median difference (GSK2586881 0.8 mg/kg - Placebo) and 95% credible interval is presented for 30 minutes post-chamber exit|||2.506|-4.142|
72519482|NCT03000686|144568499|OTHER||Median Difference (Net)|-0.662|STANDARD_DEVIATION|2.1933|||TWO_SIDED|95.0|-5.037|3.815|||||Posterior median difference (GSK2586881 0.8 mg/kg - Placebo) and 95% credible interval is presented for 15 minutes post-infusion|||3.815|-5.037|
72519483|NCT03000686|144568499|OTHER||Median Difference (Net)|-2.796|STANDARD_DEVIATION|3.4297|||TWO_SIDED|95.0|-9.729|4.027|||||Posterior median difference (GSK2586881 0.8 mg/kg - Placebo) and 95% credible interval is presented for 60 minutes post-chamber entry.|||4.027|-9.729|
72519484|NCT03000686|144568499|OTHER||Median Difference (Net)|-0.018|STANDARD_DEVIATION|4.145|||TWO_SIDED|95.0|-8.475|8.086|||||Posterior median difference (GSK2586881 0.8 mg/kg - Placebo) and 95% credible interval is presented for 2 minutes post-exercise start|||8.086|-8.475|
72519485|NCT03000686|144568499|OTHER||Median Difference (Net)|-0.291|STANDARD_DEVIATION|2.3277|||TWO_SIDED|95.0|-4.96|4.386|||||Posterior median difference (GSK2586881 0.8 mg/kg - Placebo) and 95% credible interval is presented for 30 minutes post-chamber exit|||4.386|-4.960|
72519486|NCT03000686|144568506|OTHER||Median Difference (Net)|-0.148|STANDARD_DEVIATION|0.5622|||TWO_SIDED|95.0|-1.264|0.973|||||Posterior median difference (GSK2586881 0.8 mg/kg - Placebo) and 95% credible interval for oxygen saturation at 15 minutes post-infusion is presented.|||0.973|-1.264|
72519487|NCT03000686|144568506|OTHER||Median Difference (Net)|-1.172|STANDARD_DEVIATION|2.072|||TWO_SIDED|95.0|-5.271|2.942|||||Posterior median difference (GSK2586881 0.8 mg/kg - Placebo) and 95% credible interval for oxygen saturation at 60 minutes post-chamber entry is presented.|||2.942|-5.271|
72519488|NCT03000686|144568506|OTHER||Median Difference (Net)|-0.169|STANDARD_DEVIATION|2.2351|||TWO_SIDED|95.0|-4.624|4.258|||||Posterior median difference (GSK2586881 0.8 mg/kg - Placebo) and 95% credible interval for oxygen saturation immediately post-exercise is presented.|||4.258|-4.624|
72519489|NCT03000686|144568506|OTHER||Median Difference (Net)|-0.367|STANDARD_DEVIATION|0.5649|||TWO_SIDED|95.0|-1.498|0.753|||||Posterior median difference (GSK2586881 0.8 mg/kg - Placebo) and 95% credible interval for oxygen saturation at 30 minutes post-chamber exit is presented.|||0.753|-1.498|
72519490|NCT03000686|144568507|OTHER||Median Difference (Net)|0.203|STANDARD_DEVIATION|0.8872|||TWO_SIDED|95.0|-1.578|1.968|||||Posterior median difference (GSK2586881 0.8 mg/kg - Placebo) and 95% credible interval for oxygen saturation at 15 minutes post-infusion is presented.|||1.968|-1.578|
72519491|NCT03000686|144568507|OTHER||Median Difference (Net)|3.76|STANDARD_DEVIATION|1.8799|||TWO_SIDED|95.0|-0.001|7.495|||||Posterior median difference (GSK2586881 0.8 mg/kg - Placebo) and 95% credible interval for oxygen saturation at 60 minutes post-chamber entry is presented.|||7.495|-0.001|
72519492|NCT03000686|144568507|OTHER||Median Difference (Net)|-1.029|STANDARD_DEVIATION|2.8146|||TWO_SIDED|95.0|-6.673|4.578|||||Posterior median difference (GSK2586881 0.8 mg/kg - Placebo) and 95% credible interval for oxygen saturation at 2 minutes post-exercise start is presented.|||4.578|-6.673|
72519493|NCT03000686|144568507|OTHER||Median Difference (Net)|-0.873|STANDARD_DEVIATION|0.762|||TWO_SIDED|95.0|-2.38|0.669|||||Posterior median difference (GSK2586881 0.8 mg/kg - Placebo) and 95% credible interval for oxygen saturation at 30 minutes post-chamber exit is presented.|||0.669|-2.380|
72519494|NCT01112982|144568549|OTHER|||||||0.34|||||||t-test, 2 sided|||Presence of synovial pannus and the serum urate level.||||0.34
72519495|NCT01112982|144568551|OTHER|Spearman Correlation Coefficient||||||0.73|||||||t-test, 1 sided|||The Severity of Synovial Pannus and the Serum Urate level.||||0.73
72519496|NCT01112982|144568552|OTHER|correlation between severity of synovial pannus and the serum urate level.||||||0.73|||||||t-test, 1 sided|||||||0.73
72519497|NCT01112982|144568553|OTHER|||||||0.32||||||"The presence of synovial pannus in the index joint."|t-test, 1 sided|||||||0.32
72519498|NCT01112982|144568554|OTHER|Kappa Coefficient||||||0.09|||||||t-test, 2 sided|||The absence of erosive changes.||||0.09
72519499|NCT01112982|144568554|OTHER|the absence of Intraosseous Tophi.||||||0.33|||||||t-test, 2 sided|||||||0.33
72519500|NCT01112982|144568554|OTHER|The absence of Soft Tissue Tophi||||||0.09|||||||t-test, 2 sided|||||||0.09
72519501|NCT01112982|144568554|OTHER|The absence of Joint Effusion.||||||0.31|||||||t-test, 2 sided|||||||0.31
72519502|NCT01112982|144568554|OTHER|The absence of Bone Marrow Edema.||||||0.25|||||||t-test, 2 sided|||||||0.25
72519503|NCT01112982|144568554|OTHER|The absence of Soft Tissue Edema.||||||0.14|||||||t-test, 2 sided|||||||0.14
72519504|NCT01112982|144568555|OTHER|||||||0.32||||||"The Presence of synovial Pannus in the index joint."|t-test, 1 sided|||||||0.32
72519505|NCT01112982|144568555|OTHER|||||||0.99||||||"The Severity of Synovial Pannus in the index joint."|t-test, 1 sided|||||||0.99
72519506|NCT01001234|144568563|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.55||||0.025|TWO_SIDED|95.0|1.06|2.26||The statistical significance level for the primary endpoint was α=0.0477, and had been adjusted to account for the interim sample size adjustment.|Regression, Logistic|Testing of primary endpoint and secondary endpoints was conducted sequentially in a pre-specified order, thus strongly controlling Type I error.||The comparison of rizatriptan versus placebo with respect to the primary outcome was conducted using a logistic regression model with factors for treatment, Stage 2 baseline pain severity (moderate or severe) and region (United States \[US\] or ex-US). Model-derived odds ratio and a two-sided p-value were provided. An odds ratio \>1 is in favor of the rizatriptan group.||2.26|1.06|0.025
72519507|NCT01001234|144568564|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.35||||0.08|TWO_SIDED|95.0|0.96|1.9||Secondary endpoints were to be formally tested only if the test of the primary endpoint was statistically significant at the α=0.0477 level. The secondary endpoints were then tested sequentially in a pre-specified order, each at the α=0.05 level.|Regression, Logistic|This first secondary hypothesis was not statistically significant, therefore the other two were not formally tested for statistical significance.||The comparison of rizatriptan versus placebo with respect to pain relief at 2 hours post Stage 2 dose for participants between 12 and 17 years of age was conducted using a logistic regression model with factors for treatment, Stage 2 baseline pain severity (moderate or severe) and region (US or ex-US). Model-derived odds ratio and a two-sided p-value were provided. An odds ratio \>1 is in favor of the rizatriptan group.||1.90|0.96|0.080
72519508|NCT01001234|144568565|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.52||||0.01|TWO_SIDED|95.0|1.1|2.1||This second secondary hypothesis was not formally tested since the first secondary was not statistically significant.|Regression, Logistic|||The comparison of rizatriptan versus placebo with respect to pain freedom at 2 hours post Stage 2 dose for participants between 6 and 17 years of age was conducted using a logistic regression model with factors for treatment, Stage 2 baseline pain severity (moderate or severe), age (6 to 11 years old or 12 to 17 years old), and region (US or ex-US). Model-derived odds ratio and a two-sided p-value were provided. An odds ratio \>1 is in favor of the rizatriptan group.||2.10|1.10|0.010
72519509|NCT01001234|144568566|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.22||||0.178|TWO_SIDED|95.0|0.91|1.63||This third secondary hypothesis was not formally tested since the first secondary was not statistically significant.|Regression, Logistic|||The comparison of rizatriptan versus placebo with respect to pain relief at 2 hours post Stage 2 dose for participants between 6 and 17 years of age was conducted using a logistic regression model with factors for treatment, Stage 2 baseline pain severity (moderate or severe), age (6 to 11 years old or 12 to 17 years old), and region (US or ex-US). Model-derived odds ratio and a two-sided p-value were provided. An odds ratio \>1 is in favor of the rizatriptan group.||1.63|0.91|0.178
72624922|NCT02757768|144779443|SUPERIORITY||LS Mean of Difference|8.99|STANDARD_ERROR_OF_MEAN|3.58||0.012|TWO_SIDED|95.0|1.97|16.01|||ANCOVA|||Week 12 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||16.01|1.97|0.012
72624923|NCT02757768|144779443|SUPERIORITY||LS Mean of Difference|9.25|STANDARD_ERROR_OF_MEAN|3.43||0.007|TWO_SIDED|95.0|2.53|15.98|||ANCOVA|||EoT Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||15.98|2.53|0.007
72624924|NCT02757768|144779444|SUPERIORITY||LS Mean of Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.26||0.747|TWO_SIDED|95.0|-0.63|0.38|||ANCOVA|||Week 4 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||0.38|-0.63|0.747
72624925|NCT02757768|144779444|SUPERIORITY||LS Mean of Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.32||0.393|TWO_SIDED|95.0|-0.72|0.54|||ANCOVA|||Week 8 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||0.54|-0.72|0.393
72624926|NCT02757768|144779444|SUPERIORITY||LS Mean of Difference|-0.25|STANDARD_ERROR_OF_MEAN|0.32||0.672|TWO_SIDED|95.0|-0.87|0.38|||ANCOVA|||Week 12 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||0.38|-0.87|0.672
72624927|NCT02757768|144779444|SUPERIORITY||LS Mean of Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.31||0.64|TWO_SIDED|95.0|-0.9|0.3|||ANCOVA|||EoT Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||0.30|-0.90|0.640
72405597|NCT02365636|144319438|SUPERIORITY||LSM difference from placebo|0.29||||0.202|TWO_SIDED|95.0|-0.158|0.741||5% level of significance|mixed model for repeated measures|||The Mixed Model Repeated Measures (MMRM) model with change from baseline in the weekly average of the worst NRS pain scores recorded in the evening at week 4 as the dependent variable; week, pooled study center, treatment, and treatment by visit interaction as fixed factors, baseline weekly average of the worst NRS pain scores recorded in the evening as covariate; and patient as a random effect.||0.741|-0.158|0.202
72519510|NCT00753623|144568574|SUPERIORITY_OR_OTHER||||||>|0.05|||||||t-test, 2 sided|||||||>0.05
72519511|NCT03332303|144568575|EQUIVALENCE|If the 90% confidence interval (calculated using Yates' continuity correction) on the absolute difference between the proportion of patients identified as Responders in the Test and Reference groups (pT - pR) is contained within the range \[-20%, +20%\] then therapeutic equivalence of the Test product to the Reference product was considered to have been demonstrated.|Mean Difference (Final Values)|-5.1|||||TWO_SIDED|90.0|-13.0|2.8||||||Therapeutic equivalence was evaluated for both primary and secondary endpoints in the per-protocol (PP) population.||2.8|-13.0|
72519512|NCT03332303|144568575|SUPERIORITY||% Difference|23.4|||<|0.0001|TWO_SIDED|||||The a priori threshold for statistical significance is p \< 0.05.|Cochran-Mantel-Haenszel|||Superiority of the Test and Reference products against the Placebo product for the primary endpoint was evaluated in the modified Intent-to-Treat (mITT) population using last observation carried forward (LOCF).||||<0.0001
72624928|NCT02757768|144779445|SUPERIORITY||LS Mean of Difference|-0.26|STANDARD_ERROR_OF_MEAN|0.21||0.222|TWO_SIDED|95.0|-0.68|0.16|||ANCOVA|||Week 4 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||0.16|-0.68|0.222
72624929|NCT02757768|144779445|SUPERIORITY||LS Mean of Difference|-0.71|STANDARD_ERROR_OF_MEAN|0.24||0.003|TWO_SIDED|95.0|-1.18|-0.24|||ANCOVA|||Week 8 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||-0.24|-1.18|0.003
72405598|NCT02365636|144319438|SUPERIORITY||LSM difference from placebo|0.457||||0.457|TWO_SIDED|95.0|-0.28|0.621||5% level of significance|mixed model for repeated measures|||The Mixed Model Repeated Measures (MMRM) model with change from baseline in the weekly average of the worst NRS pain scores recorded in the evening at week 4 as the dependent variable; week, pooled study center, treatment, and treatment by visit interaction as fixed factors, baseline weekly average of the worst NRS pain scores recorded in the evening as covariate; and patient as a random effect.||0.621|-0.280|0.457
72405599|NCT02365636|144319439|SUPERIORITY||Odds Ratio (OR)|0.92||||0.815|TWO_SIDED|95.0|0.456|1.856||5% level of significance|Regression, Logistic|||\>=30% improvement. P-value, odds ratio and CI for odds ratio are calculated using logistic model including response (yes/no) as dependent variable, treatment group and pooled study sites as factors.||1.856|0.456|0.815
72519513|NCT03332303|144568575|SUPERIORITY||% Difference|28.7|||<|0.0001|TWO_SIDED|||||The a priori threshold for statistical significance is p \< 0.05.|Cochran-Mantel-Haenszel|||Superiority of the Test and Reference products against the Placebo product for the primary endpoint was evaluated in the modified Intent-to-Treat (mITT) population using last observation carried forward (LOCF).||||<0.0001
72519514|NCT03332303|144568576|EQUIVALENCE|If the 90% confidence interval (calculated using Yates' continuity correction) on the absolute difference between the proportion of patients identified as Treatment Successes in the Test and Reference groups (pT - pR) is contained within the range \[-20%, +20%\] then therapeutic equivalence of the Test product to the Reference product was considered to have been demonstrated.|Mean Difference (Final Values)|-2.0|||||TWO_SIDED|90.0|-10.7|6.7||||||Therapeutic equivalence was evaluated for both primary and secondary endpoints in the per-protocol (PP) population.||6.7|-10.7|
72519515|NCT03332303|144568576|SUPERIORITY|To conclude superiority of the Test product over Placebo, the proportion of Treatment Successes in the Test product group must be numerically and statistically superior to that of the Placebo (p \< 0.05; using a two-sided Cochran-Mantel-Haenszel \[CMH\] test).|% Difference|-0.8||||0.8068|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Superiority of the Test and Reference products against the Placebo product for the secondary endpoint was evaluated in the modified Intent-to-Treat (mITT) population using last observation carried forward (LOCF).||||0.8068
72519516|NCT03332303|144568576|SUPERIORITY|To conclude superiority of the Reference product over Placebo, the proportion of Treatment Successes in the Reference product group must be numerically and statistically superior to that of the Placebo (p \< 0.05; using a two-sided Cochran-Mantel-Haenszel \[CMH\] test).|% Difference|1.8||||0.8003|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Superiority of the Test and Reference products against the Placebo product for the secondary endpoint was evaluated in the modified Intent-to-Treat (mITT) population using last observation carried forward (LOCF).||||0.8003
72519517|NCT00141037|144568599|SUPERIORITY_OR_OTHER|||||||0.79||95.0|||||Wilcoxon Nonparametric Test|||The endpoint is assessed using a Wilcoxon nonparametric test and missing values are imputed using the last observation carried forward.||||0.79
72519518|NCT00141037|144568600|SUPERIORITY_OR_OTHER|||||||0.85|||||||Fisher Exact|||The difference was analyzed using a Fisher's exact test.||||0.85
72519519|NCT00861380|144568601|SUPERIORITY|VE (defined as 1 minus Relative Risk (RR)) was calculated by comparing numbers of culture-confirmed IPD. The number of subjects with IPD in each cluster was compared between groups (10PN3+1 vs Control). This comparison was done using a negative binomial log-linear model with correction for dispersion group- and cluster- related effect.|VE (1-RR)|100.0|||<|0.0001|TWO_SIDED|95.0|82.8|100.0||P-value was calculated using a classical log linear Poisson regression with strata, without taking into account the multiplicity of the endpoints.|Regression, Linear|||Analysis aimed at providing an estimate of vaccine effectiveness (VE) at preventing culture-confirmed IPD by comparing PYARs between groups taking into account the following parameters: T, n, n+ (number of clusters with at least one event culture-confirmed ID), and n/T. VE of the 10Pn vaccine in preventing culture-confirmed IPD due to the 10 vaccine serotypes was demonstrated if the 2-sided p-value calculated for the null hypothesis H0 =(vaccine-type \[VT\] IPD VE = 0%) was lower than (\<) 5%.||100|82.8|<0.0001
72569689|NCT02944383|144669987|SUPERIORITY|||||||0.2657||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate|Ranked ANCOVA|||Week 12||||0.2657
72569690|NCT02944383|144669987|SUPERIORITY|||||||0.5996||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate|Ranked ANCOVA|||Week 12||||0.5996
72569691|NCT02944383|144669987|SUPERIORITY||Median Difference (Net)|-11.39||||0.027|TWO_SIDED|95.0|-28.81|2.08||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|EOS (average of week 10 and 12)||2.08|-28.81|0.0270
72569692|NCT02944383|144669987|SUPERIORITY||Median Difference (Net)|-0.92||||0.5263|TWO_SIDED|95.0|-16.88|15.5||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|EOS (average of week 10 and 12)||15.50|-16.88|0.5263
72624930|NCT02757768|144779445|SUPERIORITY||LS Mean of Difference|-0.65|STANDARD_ERROR_OF_MEAN|0.24||0.008|TWO_SIDED|95.0|-1.13|-0.17|||ANCOVA|||Week 12 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||-0.17|-1.13|0.008
72405600|NCT02365636|144319439|SUPERIORITY||Odds Ratio (OR)|1.05||||0.893|TWO_SIDED|95.0|0.52|2.117||5% level of significance|Regression, Logistic|||\>=30% improvement. P-value, odds ratio and CI for odds ratio are calculated using logistic model including response (yes/no) as dependent variable, treatment group and pooled study sites as factors.||2.117|0.520|0.893
72405601|NCT02365636|144319439|SUPERIORITY||Odds Ratio (OR)|0.74||||0.43|TWO_SIDED|95.0|0.357|1.55||5% level of significance|Regression, Logistic|||\>=50% improvement. P-value, odds ratio and CI for odds ratio are calculated using logistic model including response (yes/no) as dependent variable, treatment group and pooled study sites as factors.||1.550|0.357|0.430
72519520|NCT00861380|144568602|SUPERIORITY|VE (defined as 1 minus Relative Risk (RR)) was calculated by comparing numbers of culture-confirmed IPD. The number of subjects with IPD in each cluster was compared between groups (10PN2+1vsControl). This comparison was done using a negative binomial log-linear model with correction for dispersion group- and cluster- related effect.|VE (1-RR)|91.8|||=|0.0009|TWO_SIDED|95.0|58.3|99.6||p-value was calculated using a classical log linear Poisson regression with strata, without taking into account the multiplicity of the endpoints.|Regression, Linear|||Analysis aimed at providing an estimate of vaccine effectiveness (VE) at preventing culture-confirmed IPD by comparing PYARs between groups taking into account the following parameters: T, n, n+ (number of clusters with at least one event culture-confirmed ID), and n/T. VE of the 10Pn vaccine in preventing culture-confirmed IPD due to the 10 vaccine serotypes was demonstrated if the 2-sided p-value calculated for the null hypothesis H0 = (vaccine-type \[VT\] IPD VE = 0%) was lower than (\<) 5%.||99.6|58.3|= 0.0009
72519521|NCT00861380|144568606|OTHER|In 5 to 99+ Years Old Population, in Year 2010, for Non-vaccinated persons living in study cluster areas, in which study participants received 10Pn-PD-DiT vaccine, PYAR was calculated (= number of subjects reported with a culture confirmed IPD divided by sum of follow-up period expressed in years (per 100000), as well as 95% CI (2-sided profile log-likelihood ratio 95% CI using a classical log linear Poisson regression with strata). Total number of non-vaccinated persons = 2626735.|PYAR|14.657|||||TWO_SIDED|95.0|13.229|16.197|||Regression, Linear|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Culture-confirmed IPD (any serotype), number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any 10PN-PD-DIT vaccine - age stratum schedules).||16.197|13.229|
72519522|NCT00861380|144568606|OTHER|In 5 to 99+ Years Old Population, in Year 2010, for Non-vaccinated persons living in study cluster areas, in which study participants received control vaccine, PYAR was calculated (= number of subjects reported with a culture confirmed IPD divided by sum of follow-up period expressed in years (per 100000), as well as the 95% CI (2-sided profile log-likelihood ratio 95% CI using a classical log linear Poisson regression with strata). Total number of non-vaccinated persons = 1354702.|PYAR|13.582|||||TWO_SIDED|95.0|11.691|15.693|||Regression, Linear|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Culture-confirmed IPD (any serotype), number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any control (HAV or HBV) vaccine - age stratum schedules).||15.693|11.691|
72519523|NCT00861380|144568606|OTHER|In 5 to 99+ Years Old Population, in Year 2010, for Non-vaccinated persons living in study cluster areas, in which study participants received 10Pn-PD-DiT vaccine, PYAR was calculated (= number of subjects reported with a culture confirmed IPD divided by sum of follow-up period expressed in years (per 100000), as well as 95% CI (2-sided profile log-likelihood ratio 95% CI using a classical log linear Poisson regression with strata). Total number of non-vaccinated persons = 2626735.|PYAR|8.452|||||TWO_SIDED|95.0|7.376|9.639|||Regression, Linear|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Culture-confirmed IPD (vaccine serotype), number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any 10PN-PD-DIT vaccine - age stratum schedules).||9.639|7.376|
72519524|NCT00861380|144568606|OTHER|In 5 to 99+ Years Old Population, in Year 2010, for Non-vaccinated persons living in study cluster areas, in which study participants received control vaccine, PYAR was calculated (= number of subjects reported with a culture confirmed IPD divided by sum of follow-up period expressed in years (per 100000), as well as the 95% CI (2-sided profile log-likelihood ratio 95% CI using a classical log linear Poisson regression with strata). Total number of non-vaccinated persons = 1354702.|PYAR|7.603|||||TWO_SIDED|95.0|6.206|9.221|||Regression, Linear|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Culture-confirmed IPD (vaccine serotype), number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any control (HAV or HBV) vaccine - age stratum schedules).||9.221|6.206|
72519525|NCT00861380|144568606|OTHER|In 5 to 99+ Years Old Population, in Year 2010, for Non-vaccinated persons living in study cluster areas, in which study participants received 10Pn-PD-DiT vaccine, PYAR was calculated (= number of subjects reported with a culture confirmed IPD divided by sum of follow-up period expressed in years (per 100000), as well as 95% CI (2-sided profile log-likelihood ratio 95% CI using a classical log linear Poisson regression with strata). Total number of non-vaccinated persons = 2626735.|PYAR|1.637|||||TWO_SIDED|95.0|1.185|2.205|||Regression, Linear|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Culture-confirmed IPD (vaccine related), number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any 10PN-PD-DIT vaccine - age stratum schedules).||2.205|1.185|
72519526|NCT00861380|144568606|OTHER|In 5 to 99+ Years Old Population, in Year 2010, for Non-vaccinated persons living in study cluster areas, in which study participants received control vaccine, PYAR was calculated (= number of subjects reported with a culture confirmed IPD divided by sum of follow-up period expressed in years (per 100000), as well as the 95% CI (2-sided profile log-likelihood ratio 95% CI using a classical log linear Poisson regression with strata). Total number of non-vaccinated persons = 1354702.|PYAR|1.845|||||TWO_SIDED|95.0|1.194|2.724|||Regression, Linear|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Culture-confirmed IPD (vaccine related), number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any control (HAV or HBV) vaccine - age stratum schedules).||2.724|1.194|
72405602|NCT02365636|144319439|SUPERIORITY||Odds Ratio (OR)|1.02||||0.967|TWO_SIDED|95.0|0.494|2.088||5% level of significance|Regression, Logistic|||\>=50% improvement. P-value, odds ratio and CI for odds ratio are calculated using logistic model including response (yes/no) as dependent variable, treatment group and pooled study sites as factors.||2.088|0.494|0.967
72519527|NCT00861380|144568606|OTHER|In 5 to 99+ Years Old Population, in Year 2010, for Non-vaccinated persons living in study cluster areas, in which study participants received 10Pn-PD-DiT vaccine, PYAR was calculated (= number of subjects reported with a culture confirmed IPD divided by sum of follow-up period expressed in years (per 100000), as well as . 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model with strata). Total number of non-vaccinated persons = 2626735.|PYAR|3.997|||||TWO_SIDED|95.0|3.269|4.839|||Negative Binomial model with strata|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Culture-confirmed IPD (non-vaccine \& non-vaccine related), number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any 10PN-PD-DIT vaccine - age stratum schedules).||4.839|3.269|
72519528|NCT00861380|144568606|OTHER|In 5 to 99+ Years Old Population, in Year 2010, for Non-vaccinated persons living in study cluster areas, in which study participants received control vaccine, PYAR was calculated (= number of subjects reported with a culture confirmed IPD divided by sum of follow-up period expressed in years (per 100000), as well as the 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model with strata). Total number of non-vaccinated persons = 1354702.|PYAR|3.322|||||TWO_SIDED|95.0|2.423|4.445|||Negative Binomial model with strata|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Culture-confirmed IPD (non-vaccine \& non-vaccine related), number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any control (HAV or HBV) vaccine - age stratum schedules).||4.445|2.423|
72519529|NCT00861380|144568606|OTHER|In 5 to 99+ Years Old Population, in Year 2011, for Non-vaccinated persons living in study cluster areas, in which study participants received 10Pn-PD-DiT vaccine, PYAR was calculated (= number of subjects reported with a culture confirmed IPD divided by sum of follow-up period expressed in years (per 100000), as well as 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model with strata). Total number of non-vaccinated persons =2636783.|PYAR|14.487|||||TWO_SIDED|95.0|13.071|16.015|||Negative Binomial model with strata|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Culture-confirmed IPD (any serotype), number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any 10PN-PD-DIT vaccine - age stratum schedules).||16.015|13.071|
72519530|NCT00861380|144568606|OTHER|In 5 to 99+ Years Old Population, in Year 2011, for Non-vaccinated persons living in study cluster areas, in which study participants received control vaccine, PYAR was calculated (= number of subjects reported with a culture confirmed IPD divided by sum of follow-up period expressed in years (per 100000), as well as the 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model with strata). Total number of non-vaccinated persons =1360966.|PYAR|13.74|||||TWO_SIDED|95.0|11.841|15.857|||Negative Binomial model with strata|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Culture-confirmed IPD (any serotype), number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any control (HAV or HBV) vaccine - age stratum schedules).||15.857|11.841|
72519531|NCT00861380|144568606|OTHER|In 5 to 99+ Years Old Population, in Year 2011, for Non-vaccinated persons living in study cluster areas, in which study participants received 10Pn-PD-DiT vaccine, PYAR was calculated (= number of subjects reported with a culture confirmed IPD divided by sum of follow-up period expressed in years (per 100000), as well as 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model with strata). Total number of non-vaccinated persons =2636783.|PYAR|7.813|||||TWO_SIDED|95.0|6.782|8.955|||Negative Binomial model with strata|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Culture-confirmed IPD (vaccine serotype), number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any 10PN-PD-DIT vaccine - age stratum schedules).||8.955|6.782|
72519532|NCT00861380|144568606|OTHER|In 5 to 99+ Years Old Population, in Year 2011, for Non-vaccinated persons living in study cluster areas, in which study participants received control vaccine, PYAR was calculated (= number of subjects reported with a culture confirmed IPD divided by sum of follow-up period expressed in years (per 100000), as well as the 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model with strata). Total number of non-vaccinated persons =1360966.|PYAR|7.789|||||TWO_SIDED|95.0|6.377|9.42|||Negative Binomial model with strata|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Culture-confirmed IPD (vaccine serotype), number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any control (HAV or HBV) vaccine - age stratum schedules).||9.420|6.377|
72542491|NCT00106028|144614706|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.127||||0.2917||95.0|-0.111|0.365|||ANOVA|LS means and p-value are from ANOVA model with fixed effects for age group, treatment and pooled center for post-baseline.||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.||0.365|-0.111|0.2917
72519533|NCT00861380|144568606|OTHER|In 5 to 99+ Years Old Population, in Year 2011, for Non-vaccinated persons living in study cluster areas, in which study participants received 10Pn-PD-DiT vaccine, PYAR was calculated (= number of subjects reported with a culture confirmed IPD divided by sum of follow-up period expressed in years (per 100000), as well as 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model with strata). Total number of non-vaccinated persons =2636783.|PYAR|2.313|||||TWO_SIDED|95.0|1.77|2.972|||Negative Binomial model with strata|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Culture-confirmed IPD (vaccine related), number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any 10PN-PD-DIT vaccine - age stratum schedules).||2.972|1.770|
72519534|NCT00861380|144568606|OTHER|In 5 to 99+ Years Old Population, in Year 2011, for Non-vaccinated persons living in study cluster areas, in which study participants received control vaccine, PYAR was calculated (= number of subjects reported with a culture confirmed IPD divided by sum of follow-up period expressed in years (per 100000), as well as the 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model with strata). Total number of non-vaccinated persons =1360966.|PYAR|1.984|||||TWO_SIDED|95.0|1.307|2.886|||Negative Binomial model with strata|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Culture-confirmed IPD (vaccine related), number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any control (HAV or HBV) vaccine - age stratum schedules).||2.886|1.307|
72519535|NCT00861380|144568606|OTHER|In 5 to 99+ Years Old Population, in Year 2011, for Non-vaccinated persons living in study cluster areas, in which study participants received 10Pn-PD-DiT vaccine, PYAR was calculated (= number of subjects reported with a culture confirmed IPD divided by sum of follow-up period expressed in years (per 100000), as well as 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model without strata). Total number of non-vaccinated persons =2636783.|PYAR|4.172|||||TWO_SIDED|95.0|3.429|5.028|||Negative Binomial model without strata|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Culture-confirmed IPD (non-vaccine \& non-vaccine related), number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any 10PN-PD-DIT vaccine - age stratum schedules).||5.028|3.429|
72405603|NCT02365636|144319440|SUPERIORITY||LSM of difference with placebo|2.2||||0.251|TWO_SIDED|95.0|-1.55|5.92||5% level of significance|mixed model for repeated measures|||Change from baseline at Week 2 The MMRM used pooled study center, week, treatment, and treatment by week interaction as fixed factors and patient as a random factor. The unstructured covariance matrix for repeated observations within patients was used.||5.92|-1.55|0.251
72519536|NCT00861380|144568606|OTHER|In 5 to 99+ Years Old Population, in Year 2011, for Non-vaccinated persons living in study cluster areas, in which study participants received control vaccine, PYAR was calculated (= number of subjects reported with a culture confirmed IPD divided by sum of follow-up period expressed in years (per 100000), as well as the 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model without strata). Total number of non-vaccinated persons =1360966.|PYAR|3.968|||||TWO_SIDED|95.0|2.981|5.177|||Negative Binomial model without strata|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Culture-confirmed IPD (non-vaccine \& non-vaccine related), number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any control (HAV or HBV) vaccine - age stratum schedules).||5.177|2.981|
72519537|NCT00861380|144568606|OTHER|In 5 to 99+ Years Old Population, in Year 2012, for Non-vaccinated persons living in study cluster areas, in which study participants received 10Pn-PD-DiT vaccine, PYAR was calculated (= number of subjects reported with a culture confirmed IPD divided by sum of follow-up period expressed in years (per 100000), as well as 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model with strata). Total number of non-vaccinated persons =2654010.|PYAR|14.017|||||TWO_SIDED|95.0|12.628|15.516|||Negative Binomial model with strata|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Culture-confirmed IPD (any serotype), number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any 10PN-PD-DIT vaccine - age stratum schedules).||15.516|12.628|
72519538|NCT00861380|144568606|OTHER|In 5 to 99+ Years Old Population, in Year 2012, for Non-vaccinated persons living in study cluster areas, in which study participants received control vaccine, PYAR was calculated (= number of subjects reported with a culture confirmed IPD divided by sum of follow-up period expressed in years (per 100000), as well as the 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model with strata). Total number of non-vaccinated persons =1367343.|PYAR|15.066|||||TWO_SIDED|95.0|13.079|17.269|||Negative Binomial model with strata|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Culture-confirmed IPD (any serotype), number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any control (HAV or HBV) vaccine - age stratum schedules).||17.269|13.079|
72542492|NCT00106028|144614707|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.007||||0.9622||95.0|-0.304|0.319|||ANOVA|LS mean and p-value are from ANOVA model adjusted by baseline and fixed effects for age group, treatment and pooled center for post-baseline.||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.||0.319|-0.304|0.9622
72405604|NCT02365636|144319440|SUPERIORITY||LSM difference from placebo|1.3||||0.495|TWO_SIDED|95.0|-2.46|5.07||5% level of significance|mixed model for repeated measures|||Change from baseline at Week 2. The MMRM used pooled study center, week, treatment, and treatment by week interaction as fixed factors and patient as a random factor. The unstructured covariance matrix for repeated observations within patients was used.||5.07|-2.46|0.495
72405605|NCT02365636|144319440|SUPERIORITY||LSM difference from placebo|3.1||||0.123|TWO_SIDED|95.0|-0.84|7.06||5% level of significance|mixed model for repeated measures|||Change from baseline at Week 4. The MMRM used pooled study center, week, treatment, and treatment by week interaction as fixed factors and patient as a random factor. The unstructured covariance matrix for repeated observations within patients was used.||7.06|-0.84|0.123
72519539|NCT00861380|144568606|OTHER|In 5 to 99+ Years Old Population, in Year 2012, for Non-vaccinated persons living in study cluster areas, in which study participants received 10Pn-PD-DiT vaccine, PYAR was calculated (= number of subjects reported with a culture confirmed IPD divided by sum of follow-up period expressed in years (per 100000), as well as 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model with strata). Total number of non-vaccinated persons =2654010.|PYAR|5.916|||||TWO_SIDED|95.0|5.026|6.917|||Negative Binomial model with strata|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Culture-confirmed IPD (vaccine serotype), number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any 10PN-PD-DIT vaccine - age stratum schedules).||6.917|5.026|
72519540|NCT00861380|144568606|OTHER|In 5 to 99+ Years Old Population, in Year 2012, for Non-vaccinated persons living in study cluster areas, in which study participants received control vaccine, PYAR was calculated (= number of subjects reported with a culture confirmed IPD divided by sum of follow-up period expressed in years (per 100000), as well as the 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model with strata). Total number of non-vaccinated persons =1367343.|PYAR|8.557|||||TWO_SIDED|95.0|7.077|10.255|||Negative Binomial model with strata|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Culture-confirmed IPD (vaccine serotype), number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any control (HAV or HBV) vaccine - age stratum schedules).||10.255|7.077|
72519541|NCT00861380|144568606|OTHER|In 5 to 99+ Years Old Population, in Year 2012, for Non-vaccinated persons living in study cluster areas, in which study participants received 10Pn-PD-DiT vaccine, PYAR was calculated (= number of subjects reported with a culture confirmed IPD divided by sum of follow-up period expressed in years (per 100000), as well as 95% CI (2-sided profile log-likelihood ratio 95% CI using a classical log linear Poisson regression with strata). Total number of non-vaccinated persons =2654010.|PYAR|2.977|||||TWO_SIDED|95.0|2.357|3.71|||Regression, Linear|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Culture-confirmed IPD (vaccine related), number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any 10PN-PD-DIT vaccine - age stratum schedules).||3.710|2.357|
72519542|NCT00861380|144568606|OTHER|In 5 to 99+ Years Old Population, in Year 2012, for Non-vaccinated persons living in study cluster areas, in which study participants received control vaccine, PYAR was calculated (= number of subjects reported with a culture confirmed IPD divided by sum of follow-up period expressed in years (per 100000), as well as the 95% CI (2-sided profile log-likelihood ratio 95% CI using a classical log linear Poisson regression with strata). Total number of non-vaccinated persons =1367343.|PYAR|2.048|||||TWO_SIDED|95.0|1.361|2.96|||Regression, Linear|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Culture-confirmed IPD (vaccine related), number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any control (HAV or HBV) vaccine - age stratum schedules).||2.960|1.361|
72519543|NCT00861380|144568606|OTHER|In 5 to 99+ Years Old Population, in Year 2012, for Non-vaccinated persons living in study cluster areas, in which study participants received 10Pn-PD-DiT vaccine, PYAR was calculated (= number of subjects reported with a culture confirmed IPD divided by sum of follow-up period expressed in years (per 100000), as well as 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model with strata). Total number of non-vaccinated persons =2654010.|PYAR|5.011|||||TWO_SIDED|95.0|4.196|5.939|||Negative Binomial model with strata|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Culture-confirmed IPD (non-vaccine \& non-vaccine related), number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any 10PN-PD-DIT vaccine - age stratum schedules).||5.939|4.196|
72569693|NCT02944383|144669988|SUPERIORITY|||||||0.0345||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.0345
72405606|NCT02365636|144319440|SUPERIORITY||LSM difference from placebo|2.8||||0.16|TWO_SIDED|95.0|-1.12|6.77||5% level of significance.|miex model for repeated measures|||Change from baseline at Week 4. The MMRM used pooled study center, week, treatment, and treatment by week interaction as fixed factors and patient as a random factor. The unstructured covariance matrix for repeated observations within patients was used.||6.77|-1.12|0.160
72405607|NCT02365636|144319441|SUPERIORITY||LSM difference from placebo|1.3||||0.609|TWO_SIDED|95.0|-3.81|6.48||5% level of significance|ANCOVA|ANCOVA model includes study center, treatment, and baseline.||||6.48|-3.81|0.609
72405608|NCT02365636|144319441|SUPERIORITY||LSM difference with placebo|2.1||||0.427|TWO_SIDED|95.0|-3.05|7.19||5% level of significance|ANCOVA|ANCOVA model includes study center, treatment, and baseline.||||7.19|-3.05|0.427
72519544|NCT00861380|144568606|OTHER|In 5 to 99+ Years Old Population, in Year 2012, for Non-vaccinated persons living in study cluster areas, in which study participants received control vaccine, PYAR was calculated (= number of subjects reported with a culture confirmed IPD divided by sum of follow-up period expressed in years (per 100000), as well as the 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model with strata). Total number of non-vaccinated persons =1367343.|PYAR|4.315|||||TWO_SIDED|95.0|3.285|5.566|||Negative Binomial model with strata|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Culture-confirmed IPD (non-vaccine \& non-vaccine related), number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any control (HAV or HBV) vaccine - age stratum schedules).||5.566|3.285|
72519545|NCT00861380|144568614|OTHER|In 5 to 99+ Years Old Population, in Year 2010, for Non-vaccinated persons living in study cluster areas, in which study participants received 10Pn-PD-DiT vaccine, PYAR was calculated (= number of subjects reported with a Hospital-diagnosed Pneumonia divided by sum of follow-up period expressed in years (per 1000), as well as 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model with strata). Total number of non-vaccinated persons =2626735.|PYAR|9.218|||||TWO_SIDED|95.0|9.103|9.335|||Negative Binomial model with strata|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Hospital-diagnosed Pneumonia, number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any 10PN-PD-DIT vaccine - age stratum schedules).||9.335|9.103|
72519546|NCT00861380|144568614|OTHER|In 5 to 99+ Years Old Population, in Year 2010, for Non-vaccinated persons living in study cluster areas, in which study participants received control vaccine, PYAR was calculated (= number of subjects reported with a Hospital-diagnosed Pneumonia divided by sum of follow-up period expressed in years (per 1000), as well as 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model with strata). Total number of non-vaccinated persons =1354702.|PYAR|9.212|||||TWO_SIDED|95.0|9.052|9.375|||Negative Binomial model with strata|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Hospital-diagnosed Pneumonia, number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any control (HAV or HBV) vaccine - age stratum schedules).||9.375|9.052|
72519547|NCT00861380|144568614|OTHER|In 5 to 99+ Years Old Population, in Year 2011, for Non-vaccinated persons living in study cluster areas, in which study participants received 10Pn-PD-DiT vaccine, PYAR was calculated (= number of subjects reported with a Hospital-diagnosed Pneumonia divided by sum of follow-up period expressed in years (per 1000), as well as 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model with strata). Total number of non-vaccinated persons =2636783.|PYAR|10.5|||||TWO_SIDED|95.0|10.378|10.624|||Negative Binomial model with strata|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Hospital-diagnosed Pneumonia, number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any 10PN-PD-DIT vaccine - age stratum schedules).||10.624|10.378|
72519548|NCT00861380|144568614|OTHER|In 5 to 99+ Years Old Population, in Year 2011, for Non-vaccinated persons living in study cluster areas, in which study participants received control vaccine, PYAR was calculated (= number of subjects reported with a Hospital-diagnosed Pneumonia divided by sum of follow-up period expressed in years (per 1000), as well as 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model with strata). Total number of non-vaccinated persons =1360966.|PYAR|10.429|||||TWO_SIDED|95.0|10.259|10.601|||Negative Binomial model with strata|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Hospital-diagnosed Pneumonia, number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any control (HAV or HBV) vaccine - age stratum schedules).||10.601|10.259|
72519549|NCT00861380|144568614|OTHER|In 5 to 99+ Years Old Population, in Year 2012, for Non-vaccinated persons living in study cluster areas, in which study participants received 10Pn-PD-DiT vaccine, PYAR was calculated (= number of subjects reported with a Hospital-diagnosed Pneumonia divided by sum of follow-up period expressed in years (per 1000), as well as 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model with strata). Total number of non-vaccinated persons =2654010.|PYAR|10.118|||||TWO_SIDED|95.0|9.997|10.239|||Negative Binomial model with strata|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Hospital-diagnosed Pneumonia, number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any 10PN-PD-DIT vaccine - age stratum schedules).||10.239|9.997|
72519550|NCT00861380|144568614|OTHER|In 5 to 99+ Years Old Population, in Year 2012, for Non-vaccinated persons living in study cluster areas, in which study participants received control vaccine, PYAR was calculated (= number of subjects reported with a Hospital-diagnosed Pneumonia divided by sum of follow-up period expressed in years (per 1000), as well as 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model with strata). Total number of non-vaccinated persons =1367343.|PYAR|9.921|||||TWO_SIDED|95.0|9.755|10.088|||Negative Binomial model with strata|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Hospital-diagnosed Pneumonia, number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any control (HAV or HBV) vaccine - age stratum schedules).||10.088|9.755|
72624931|NCT02757768|144779445|SUPERIORITY||LS Mean of Difference|-0.67|STANDARD_ERROR_OF_MEAN|0.23||0.004|TWO_SIDED|95.0|-1.13|-0.21|||ANCOVA|||EoT Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||-0.21|-1.13|0.004
72519551|NCT00861380|144568622|OTHER|In 0 to 7 Years Old Population, in Year 2009, for Non-vaccinated persons living in study cluster areas, in which study participants received 10Pn-PD-DiT vaccine, PYAR was calculated (= number of subjects reported with Tympanostomy Tube Placement divided by sum of follow-up period expressed in years (per 1000), as well as 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model with strata). Total number of non-vaccinated persons =229978.|PYAR|22.624|||||TWO_SIDED|95.0|22.02|23.24|||Negative Binomial model with strata|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Tympanostomy Tube Placements, number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any 10PN-PD-DIT vaccine - age stratum schedules).||23.240|22.020|
72519552|NCT00861380|144568622|OTHER|In 0 to 7 Years Old Population, in Year 2009, for Non-vaccinated persons living in study cluster areas, in which study participants received control vaccine, PYAR was calculated (= number of subjects reported with Tympanostomy Tube Placement divided by sum of follow-up period expressed in years (per 1000), as well as 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model with strata). Total number of non-vaccinated persons =120190.|PYAR|22.747|||||TWO_SIDED|95.0|21.912|23.606|||Negative Binomial model with strata|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Tympanostomy Tube Placements, number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any control (HAV or HBV) vaccine - age stratum schedules).||23.606|21.912|
72519553|NCT00861380|144568622|OTHER|In 0 to 7 Years Old Population, in Year 2010, for Non-vaccinated persons living in study cluster areas, in which study participants received 10Pn-PD-DiT vaccine, PYAR was calculated (= number of subjects reported with Tympanostomy Tube Placement divided by sum of follow-up period expressed in years (per 1000), as well as 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model with strata). Total number of non-vaccinated persons =214181.|PYAR|24.503|||||TWO_SIDED|95.0|23.852|25.166|||Negative Binomial model with strata|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Tympanostomy Tube Placements, number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any 10PN-PD-DIT vaccine - age stratum schedules).||25.166|23.852|
72519554|NCT00861380|144568622|OTHER|In 0 to 7 Years Old Population, in Year 2010, for Non-vaccinated persons living in study cluster areas, in which study participants received control vaccine, PYAR was calculated (= number of subjects reported with Tympanostomy Tube Placement divided by sum of follow-up period expressed in years (per 1000), as well as 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model with strata). Total number of non-vaccinated persons =112060.|PYAR|26.236|||||TWO_SIDED|95.0|25.308|27.189|||Negative Binomial model with strata|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Tympanostomy Tube Placements, number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any control (HAV or HBV) vaccine - age stratum schedules).||27.189|25.308|
72569694|NCT02944383|144669988|SUPERIORITY|||||||0.2709||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.2709
72569695|NCT02944383|144669988|SUPERIORITY|||||||0.3255||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.3255
72569696|NCT02944383|144669988|SUPERIORITY|||||||0.7391||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.7391
72569697|NCT02944383|144669988|SUPERIORITY|||||||0.0808||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||EOS (average of week 10 and 12)||||0.0808
72569698|NCT02944383|144669988|SUPERIORITY|||||||0.6509||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||EOS (average of week 10 and 12)||||0.6509
72569699|NCT02944383|144669989|SUPERIORITY|||||||0.0004||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.0004
72624932|NCT02757768|144779446|SUPERIORITY||LS Mean of Difference|0.1|STANDARD_ERROR_OF_MEAN|0.4||0.723|TWO_SIDED|95.0|-0.6|0.9|||ANCOVA|||Week 4 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||0.9|-0.6|0.723
72569700|NCT02944383|144669989|SUPERIORITY|||||||0.0412||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.0412
72624933|NCT02757768|144779446|SUPERIORITY||LS Mean of Difference|0.2|STANDARD_ERROR_OF_MEAN|0.4||0.7|TWO_SIDED|95.0|-0.7|1.0|||ANCOVA|||Week 8 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||1.0|-0.7|0.700
72624934|NCT02757768|144779446|SUPERIORITY||LS Mean of Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.5||0.4|TWO_SIDED|95.0|-1.3|0.5|||ANCOVA|||Week 12 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||0.5|-1.3|0.400
72624935|NCT02757768|144779446|SUPERIORITY||LS Mean of Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.4||0.812|TWO_SIDED|95.0|-1.0|0.8|||ANCOVA|||EoT Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||0.8|-1.0|0.812
72624936|NCT02757768|144779447|SUPERIORITY||LS Mean of Difference|0.4|STANDARD_ERROR_OF_MEAN|0.3||0.121|TWO_SIDED|95.0|-0.1|0.9|||ANCOVA|||Week 4 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||0.9|-0.1|0.121
72624937|NCT02757768|144779447|SUPERIORITY||LS Mean of Difference|0.3|STANDARD_ERROR_OF_MEAN|0.3||0.241|TWO_SIDED|95.0|-0.2|0.8|||ANCOVA|||Week 8 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||0.8|-0.2|0.241
72405609|NCT02365636|144319442|SUPERIORITY||LSM difference from placebo|0.2||||0.166|TWO_SIDED|95.0|-0.07|0.43||5% level of significance|mixed model for repeated measures|||Week 2 Mixed model for repeated measures (MMRM) with pooled study center, week, treatment, and treatment by week interaction as fixed factors and patient as a random factor. The unstructured covariance matrix for repeated observations within patients was used.||0.43|-0.07|0.166
72519555|NCT00861380|144568622|OTHER|In 0 to 7 Years Old Population, in Year 2011, for Non-vaccinated persons living in study cluster areas, in which study participants received 10Pn-PD-DiT vaccine, PYAR was calculated (= number of subjects reported with Tympanostomy Tube Placement divided by sum of follow-up period expressed in years (per 1000), as well as 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model with strata). Total number of non-vaccinated persons =211914.|PYAR|27.502|||||TWO_SIDED|95.0|26.81|28.207|||Negative Binomial model with strata|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Tympanostomy Tube Placements, number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any 10PN-PD-DIT vaccine - age stratum schedules).||28.207|26.810|
72519556|NCT00861380|144568622|OTHER|In 0 to 7 Years Old Population, in Year 2011, for Non-vaccinated persons living in study cluster areas, in which study participants received control vaccine, PYAR was calculated (= number of subjects reported with Tympanostomy Tube Placement divided by sum of follow-up period expressed in years (per 1000), as well as 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model with strata). Total number of non-vaccinated persons =111071.|PYAR|26.1||||||95.0|25.171|27.055|||Negative Binomial model with strata|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Tympanostomy Tube Placements, number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any control (HAV or HBV) vaccine - age stratum schedules).||27.055|25.171|
72519557|NCT00861380|144568622|OTHER|In 0 to 7 Years Old Population, in Year 2012, for Non-vaccinated persons living in study cluster areas, in which study participants received 10Pn-PD-DiT vaccine, PYAR was calculated (= number of subjects reported with Tympanostomy Tube Placement divided by sum of follow-up period expressed in years (per 1000), as well as 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model with strata). Total number of non-vaccinated persons =213913.|PYAR|28.661|||||TWO_SIDED|95.0|27.958|29.377|||Negative Binomial model with strata|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Tympanostomy Tube Placements, number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any 10PN-PD-DIT vaccine - age stratum schedules).||29.377|27.958|
72542493|NCT00106028|144614708|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.009||||0.9596|TWO_SIDED|95.0|-0.336|0.354|||ANOVA|LS means and p-value are from ANOVA model adjusted by baseline and fixed effects for age group, treatment and pooled center for post-baseline.||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.||0.354|-0.336|0.9596
72624938|NCT02757768|144779447|SUPERIORITY||LS Mean of Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.3||0.843|TWO_SIDED|95.0|-0.6|0.5|||ANCOVA|||Week 12 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||0.5|-0.6|0.843
72624939|NCT02757768|144779447|SUPERIORITY||LS Mean of Difference|0.1|STANDARD_ERROR_OF_MEAN|0.3||0.679|TWO_SIDED|95.0|-0.4|0.7|||ANCOVA|||EoT Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||0.7|-0.4|0.679
72405610|NCT02365636|144319442|SUPERIORITY||LSM difference from placebo|0.3||||0.046|TWO_SIDED|95.0|0.0|0.51||5% level of significance|mixed model for repeated measures|||Week 2 Mixed model for repeated measures (MMRM) with pooled study center, week, treatment, and treatment by week interaction as fixed factors and patient as a random factor. The unstructured covariance matrix for repeated observations within patients was used.||0.51|0.00|0.046
72405611|NCT02365636|144319442|SUPERIORITY||LSM difference from placebo|0.2||||0.152|TWO_SIDED|95.0|-0.08|0.53||5% level of significance|mixed model for repeated measures|||Week 4 Mixed model for repeated measures (MMRM) with pooled study center, week, treatment, and treatment by week interaction as fixed factors and patient as a random factor. The unstructured covariance matrix for repeated observations within patients was used.||0.53|-0.08|0.152
72405612|NCT02365636|144319442|SUPERIORITY||LSM difference from placebo|0.1||||0.342|TWO_SIDED|95.0|-0.16|0.46||5% level of significance|mixed model for repeated measures|||Week 4 Mixed model for repeated measures (MMRM) with pooled study center, week, treatment, and treatment by week interaction as fixed factors and patient as a random factor. The unstructured covariance matrix for repeated observations within patients was used.||0.46|-0.16|0.342
72405613|NCT02365636|144319443|SUPERIORITY||LSM difference from placebo|0.2||||0.311|TWO_SIDED|95.0|-0.22|0.7||5% level of significance|mixed model for repeated measures|||Change from baseline at Week 2 The inferential model includes study center, week, treatment, and treatment by week interaction as the fixed factors; baseline as a covariate and unstructured variance-covariance structure in the initial model.||0.70|-0.22|0.311
72405614|NCT02365636|144319443|SUPERIORITY||LSM difference from placebo|0.3||||0.262|TWO_SIDED|95.0|-0.2|0.73||5% level of significance|mixed model for repeated measures|||Change from baseline at week 2 The inferential model includes study center, week, treatment, and treatment by week interaction as the fixed factors; baseline as a covariate and unstructured variance-covariance structure in the initial model.||0.73|-0.20|0.262
72405615|NCT02365636|144319443|SUPERIORITY||LSM difference from placebo|0.5||||0.065|TWO_SIDED|95.0|-0.03|0.97||5% level of significance|mixed model for repeated measures|||Change from baseline at week 4 The inferential model includes study center, week, treatment, and treatment by week interaction as the fixed factors; baseline as a covariate and unstructured variance-covariance structure in the initial model.||0.97|-0.03|0.065
72405616|NCT02365636|144319443|SUPERIORITY||LSM difference from placebo|0.3||||0.296|TWO_SIDED|95.0|-0.23|0.76||5% level of significance|mixed model for repeated measures|||Change from baseline at week 4 The inferential model includes study center, week, treatment, and treatment by week interaction as the fixed factors; baseline as a covariate and unstructured variance-covariance structure in the initial model.||0.76|-0.23|0.296
72569701|NCT02944383|144669989|SUPERIORITY|||||||0.1937||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.1937
72569702|NCT02944383|144669989|SUPERIORITY|||||||0.474||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.4740
72569703|NCT02944383|144669989|SUPERIORITY||Median Difference (Net)|-14.32||||0.0116|TWO_SIDED|95.0|-34.13|3.89||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|EOS (average of week 10 and 12)||3.89|-34.13|0.0116
72405617|NCT02365636|144319444|SUPERIORITY|||||||0.245||||||5% level of significance|Regression, Cox|||||||0.245
72405618|NCT02365636|144319444|SUPERIORITY|||||||0.304||||||5% level of significance|Regression, Cox|||||||0.304
72405619|NCT02365636|144319445|SUPERIORITY||LSM difference from placebo|-0.1||||0.556|TWO_SIDED|95.0|-0.61|0.33||5% level of significance|mixed model for repeated measures|||Change from baseline at week 2 The inferential model includes study center, week, treatment, and treatment by week interaction as the fixed factors; baseline as a covariate and unstructured variance-covariance structure in the initial model.||0.33|-0.61|0.556
72405620|NCT02365636|144319445|SUPERIORITY||LSM difference from placebo|-0.2||||0.482|TWO_SIDED|95.0|-0.65|0.31||5% level of significance|mixed model for repeated measures|||Change from baseline at week 2 The inferential model includes study center, week, treatment, and treatment by week interaction as the fixed factors; baseline as a covariate and unstructured variance-covariance structure in the initial model.||0.31|-0.65|0.482
72405621|NCT02365636|144319445|SUPERIORITY||LSM difference from placebo|-0.3||||0.333|TWO_SIDED|95.0|-0.81|0.28||5% level of significance|mixed model for repeated measures|||Change from baseline at week 4. The inferential model includes study center, week, treatment, and treatment by week interaction as the fixed factors; baseline as a covariate and unstructured variance-covariance structure in the initial model.||0.28|-0.81|0.333
72405622|NCT02365636|144319445|SUPERIORITY||LSM difference from placebo|-0.1||||0.833|TWO_SIDED|95.0|-0.62|0.5||5% level of significance|mixed model for repeated measures|||Change from baseline at week 4 The inferential model includes study center, week, treatment, and treatment by week interaction as the fixed factors; baseline as a covariate and unstructured variance-covariance structure in the initial model.||0.50|-0.62|0.833
72405623|NCT02365636|144319446|SUPERIORITY||LSM difference from placebo|-0.2||||0.563|TWO_SIDED|95.0|-0.75|0.41||5% level of significance|mixed model for repeated measures|||Change from baseline at week 2 The inferential model includes study center, week, treatment, and treatment by week interaction as the fixed factors; baseline as a covariate and unstructured variance-covariance structure in the initial model.||0.41|-0.75|0.563
72405624|NCT02365636|144319446|SUPERIORITY||LSM difference from placebo|-0.1||||0.804|TWO_SIDED|95.0|-0.64|0.5||5% level of significance|mixed model for repeated measures|||Change from baseline at week 2. The inferential model includes study center, week, treatment, and treatment by week interaction as the fixed factors; baseline as a covariate and unstructured variance-covariance structure in the initial model.||0.50|-0.64|0.804
72405625|NCT02365636|144319446|SUPERIORITY||LSM difference from placebo|0.1||||0.714|TWO_SIDED|95.0|-0.49|0.71||5% level of significance|mixed model for repeated measures|||Change from baseline at week 4 The inferential model includes study center, week, treatment, and treatment by week interaction as the fixed factors; baseline as a covariate and unstructured variance-covariance structure in the initial model.||0.71|-0.49|0.714
72569704|NCT02944383|144669989|SUPERIORITY||Median Difference (Net)|-3.66||||0.1109|TWO_SIDED|95.0|-23.85|14.26||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|EOS (average of week 10 and 12)||14.26|-23.85|0.1109
72519558|NCT00861380|144568622|OTHER|In 0 to 7 Years Old Population, in Year 2012, for Non-vaccinated persons living in study cluster areas, in which study participants received control vaccine, PYAR was calculated (= number of subjects reported with Tympanostomy Tube Placement divided by sum of follow-up period expressed in years (per 1000), as well as 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model with strata). Total number of non-vaccinated persons =111414.|PYAR|29.835|||||TWO_SIDED|95.0|28.843|30.85|||Negative Binomial model with strata|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Tympanostomy Tube Placements, number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any control (HAV or HBV) vaccine - age stratum schedules).||30.850|28.843|
72519559|NCT00861380|144568626|OTHER|In 0 to 7 Years Old Population, in Year 2009, for Non-vaccinated persons living in study cluster areas, in which study participants received 10Pn-PD-DiT vaccine, PYAR was calculated (= number of subjects reported with Antimicrobial Prescriptions divided by sum of follow-up period expressed in years (per 1000), as well as 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model with strata). Total number of non-vaccinated persons =229978.|PYAR|816.813|||||TWO_SIDED|95.0|815.226|818.392|||Negative Binomial model with strata|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Antimicrobial Prescriptions, number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any 10PN-PD-DIT vaccine - age stratum schedules).||818.392|815.226|
72519560|NCT00861380|144568626|OTHER|In 0 to 7 Years Old Population, in Year 2009, for Non-vaccinated persons living in study cluster areas, in which study participants received control vaccine, PYAR was calculated (= number of subjects reported with Antimicrobial Prescriptions divided by sum of follow-up period expressed in years (per 1000), as well as 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model with strata). Total number of non-vaccinated persons =120190.|PYAR|841.176|||||TWO_SIDED|95.0|839.098|843.239|||Negative Binomial model with strata|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Antimicrobial Prescriptions, number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any control (HAV or HBV) vaccine - age stratum schedules).||843.239|839.098|
72519561|NCT00861380|144568626|OTHER|In 0 to 7 Years Old Population, in Year 2009, for Non-vaccinated persons living in study cluster areas, in which study participants received 10Pn-PD-DiT vaccine, PYAR was calculated (= number of subjects reported with recommended Antimicrobial Prescriptions divided by sum of follow-up period expressed in years (per 1000), as well as 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model with strata). Total number of non-vaccinated persons =229978.|PYAR|702.245|||||TWO_SIDED|95.0|700.372|704.114|||Negative Binomial model with strata|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Antimicrobial Prescriptions recommended for Acute Otitis Media (AOM)/Respiratory Tract Infections (RTI), number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any 10PN-PD-DIT vaccine - age stratum schedules).||704.114|700.372|
72519562|NCT00861380|144568626|OTHER|In 0 to 7 Years Old Population, in Year 2009, for Non-vaccinated persons living in study cluster areas, in which study participants received control vaccine, PYAR was calculated (= number of subjects reported with recommended Antimicrobial Prescriptions divided by sum of follow-up period expressed in years (per 1000), as well as 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model with strata). Total number of non-vaccinated persons =120190.|PYAR|720.9|||||TWO_SIDED|95.0|718.355|723.435|||negative Binomial model with strata|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Antimicrobial Prescriptions recommended for AOM/RTI, number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any control (HAV or HBV) vaccine - age stratum schedules).||723.435|718.355|
72542494|NCT00106028|144614709|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.107||||0.34||95.0|-0.114|0.328|||ANOVA|LS means and p-value are from ANOVA model with fixed effects for age group, treatment and pooled center for post-baseline.||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.||0.328|-0.114|0.3400
72569705|NCT02944383|144669990|SUPERIORITY|||||||0.0002||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.0002
72569706|NCT02944383|144669990|SUPERIORITY|||||||0.0161||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.0161
72405626|NCT02365636|144319446|SUPERIORITY||LSM difference from placebo|0.0||||0.871|TWO_SIDED|95.0|-0.64|0.55||5% level of siignificance|mixed model for repeated measures|||Change from baseline at week 4. The inferential model includes study center, week, treatment, and treatment by week interaction as the fixed factors; baseline as a covariate and unstructured variance-covariance structure in the initial model.||0.55|-0.64|0.871
72569707|NCT02944383|144669990|SUPERIORITY|||||||0.3043||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.3043
72405627|NCT01802775|144319479|OTHER||Treatment Difference|-3.9|||||TWO_SIDED|95.0|-17.3|9.5||||||Treatment difference was edoxaban - clopidogrel. For the treatment difference, 95% Confidence interval was calculated using a normal approximation to the binomial distribution.||9.5|-17.3|
72405628|NCT01236196|144319484|SUPERIORITY_OR_OTHER|||||||0.11|TWO_SIDED||||||Mixed Models Analysis|||||||0.11
72405629|NCT01236196|144319485|SUPERIORITY_OR_OTHER|||||||0.8|TWO_SIDED||||||Mixed Models Analysis|||||||0.80
72405630|NCT01236196|144319486|SUPERIORITY_OR_OTHER|||||||0.01|TWO_SIDED||||||Mixed Models Analysis|||||||0.01
72405631|NCT01236196|144319487|SUPERIORITY_OR_OTHER|||||||0.09|TWO_SIDED||||||Mixed Models Analysis|||||||0.09
72405632|NCT00386256|144319488|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||Statistical analyses included descriptive statistics to assess demographic and medical characteristics, safety, text messaging or phone adherence, exercise adherence, and patient satisfaction. T-tests were used to determine significant differences between the HB text messaging and telephone groups (with inpatients and outpatients combined within each group). All analyses were conducted using SPSS version 14.0 for Windows.||||<.05
72519563|NCT00861380|144568626|OTHER|In 0 to 7 Years Old Population, in Year 2010, for Non-vaccinated persons living in study cluster areas, in which study participants received 10Pn-PD-DiT vaccine, PYAR was calculated (= number of subjects reported with Antimicrobial Prescriptions divided by sum of follow-up period expressed in years (per 1000), as well as 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model with strata). Total number of non-vaccinated persons =214181.|PYAR|929.844|||||TWO_SIDED|95.0|928.755|930.923|||Negative Binomial model with strata|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Antimicrobial Prescriptions, number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any 10PN-PD-DIT vaccine - age stratum schedules).||930.923|928.755|
72519564|NCT00861380|144568626|OTHER|In 0 to 7 Years Old Population, in Year 2010, for Non-vaccinated persons living in study cluster areas, in which study participants received control vaccine, PYAR was calculated (= number of subjects reported with Antimicrobial Prescriptions divided by sum of follow-up period expressed in years (per 1000), as well as 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model with strata). Total number of non-vaccinated persons =112060.|PYAR|953.025|||||TWO_SIDED|95.0|951.77|954.257|||Negative Binomial model with strata|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Antimicrobial Prescriptions, number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any control (HAV or HBV) vaccine - age stratum schedules).||954.257|951.770|
72519565|NCT00861380|144568626|OTHER|In 0 to 7 Years Old Population, in Year 2010, for Non-vaccinated persons living in study cluster areas, in which study participants received 10Pn-PD-DiT vaccine, PYAR was calculated (= number of subjects reported with recommended Antimicrobial Prescriptions divided by sum of follow-up period expressed in years (per 1000), as well as 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model with strata). Total number of non-vaccinated persons =214181.|PYAR|804.703|||||TWO_SIDED|95.0|803.017|806.38|||Negative Binomial model with strata|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Antimicrobial Prescriptions recommended for AOM/RTI, number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any 10PN-PD-DIT vaccine - age stratum schedules).||806.380|803.017|
72542495|NCT00106028|144614710|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.029||||0.6218|TWO_SIDED|95.0|-0.084|0.142|||ANOVA|LS means and p-value are from ANCOVA model adjusted by baseline and fixed effects for age group, treatment and pooled center for post-baseline.||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.||0.142|-0.084|0.6218
72542496|NCT03276962|144614744|SUPERIORITY||Incremental vaccine efficacy|-21.0||||0.154|TWO_SIDED|95.0|-57.0|7.0|||Regression, Cox|The 95% Confidence Interval of the incremental vaccine efficacy estimates was calculated from Cox regression model.||To demonstrate the superiority of a 3-dose schedule of GSK Biologicals' malaria vaccine RTS,S/AS01E with a fractional third dose at Month 2 (Fx012-14-mFxD Group) compared to a standard schedule of RTS,S/AS01E with 3 full doses (R012-20 + R012-14 Group) in terms of vaccine efficacy against clinical malaria (primary case definition) over 12 months post-Dose 3.||7|-57|0.154
72405633|NCT00386256|144319489|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||Statistical analyses included descriptive statistics to assess demographic and medical characteristics, safety, text messaging or phone adherence, exercise adherence, and patient satisfaction. T-tests were used to determine significant differences between the HB text messaging and telephone groups (with inpatients and outpatients combined within each group). All analyses were conducted using SPSS version 14.0 for Windows.||||<.05
72405634|NCT01096784|144319493|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0642||95.0|||||CMH Row Mean Score Test|||||||0.0642
72405635|NCT03761628|144319507|OTHER|The clinical performance endpoint - Clinical cure rate on Day 7 - was calculated and presented together with a one-sided 95% CI based on the exact binomial distribution (Clopper-Pearson).|Clinical cure rate|40.9|||||ONE_SIDED|95.0|23.3|||||||"It was assumed that the true cure rate was equal to 70%, therefore 22 patients were needed to obtain 90% chance (90% power) to show that the one-sided 95% CI for the observed cure rate was above 40%.~Hypotheses for the primary clinical performance endpoint:~* Null hypothesis: Clinical cure rate is less than or equal to 40%.~* Alternative hypothesis (one-sided): Clinical cure rate is above 40%."|||23.3|
72405636|NCT03761628|144319508|OTHER|Results are based on the exact binomial distribution (Clopper-Pearson).|Proportion with reduction|72.7|||||TWO_SIDED|95.0|49.8|89.3||||||||89.3|49.8|
72624940|NCT02757768|144779448|SUPERIORITY||LS Mean of Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.2||0.175|TWO_SIDED|95.0|-0.7|0.1|||ANCOVA|||Week 4 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||0.1|-0.7|0.175
72624941|NCT02757768|144779448|SUPERIORITY||LS Mean of Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.2||0.43|TWO_SIDED|95.0|-0.6|0.2|||ANCOVA|||Week 8 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||0.2|-0.6|0.430
72624942|NCT02757768|144779448|SUPERIORITY||LS Mean of Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.2||0.141|TWO_SIDED|95.0|-0.8|0.1|||ANCOVA|||Week 12 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||0.1|-0.8|0.141
72405637|NCT03761628|144319510|OTHER|Results are based on the exact binomial distribution (Clopper-Pearson).|Recurrence rate Day 14|12.5|||||TWO_SIDED|95.0|0.3|52.7||||||||52.7|0.3|
72405638|NCT03761628|144319510|OTHER|Results are based on the exact binomial distribution (Clopper-Pearson).|Recurrence rate Day 35|0.0|||||TWO_SIDED|95.0|0.0|45.9||||||||45.9|0|
72519566|NCT00861380|144568626|OTHER|In 0 to 7 Years Old Population, in Year 2010, for Non-vaccinated persons living in study cluster areas, in which study participants received control vaccine, PYAR was calculated (= number of subjects reported with recommended Antimicrobial Prescriptions divided by sum of follow-up period expressed in years (per 1000), as well as 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model with strata). Total number of non-vaccinated persons =112060.|PYAR|818.66|||||TWO_SIDED|95.0|816.391|820.912|||Negative Binomial model with strata|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Antimicrobial Prescriptions recommended for AOM/RTI, number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any control (HAV or HBV) vaccine - age stratum schedules).||820.912|816.391|
72519567|NCT00861380|144568626|OTHER|In 0 to 7 Years Old Population, in Year 2011, for Non-vaccinated persons living in study cluster areas, in which study participants received 10Pn-PD-DiT vaccine, PYAR was calculated (= number of subjects reported with Antimicrobial Prescriptions divided by sum of follow-up period expressed in years (per 1000), as well as 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model with strata). Total number of non-vaccinated persons =211914.|PYAR|916.079|||||TWO_SIDED|95.0|914.891|917.256|||Negative Binomial model with strata|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Antimicrobial Prescriptions, number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any 10PN-PD-DIT vaccine - age stratum schedules).||917.256|914.891|
72519568|NCT00861380|144568626|OTHER|In 0 to 7 Years Old Population, in Year 2011, for Non-vaccinated persons living in study cluster areas, in which study participants received control vaccine, PYAR was calculated (= number of subjects reported with Antimicrobial Prescriptions divided by sum of follow-up period expressed in years (per 1000), as well as 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model with strata). Total number of non-vaccinated persons =111071.|PYAR|928.568|||||TWO_SIDED|95.0|927.038|930.076|||Negative Binomial model with strata|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Antimicrobial Prescriptions, number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any control (HAV or HBV) vaccine - age stratum schedules).||930.076|927.038|
72519569|NCT00861380|144568626|OTHER|In 0 to 7 Years Old Population, in Year 2011, for Non-vaccinated persons living in study cluster areas, in which study participants received 10Pn-PD-DiT vaccine, PYAR was calculated (= number of subjects reported with recommended Antimicrobial Prescriptions divided by sum of follow-up period expressed in years (per 1000), as well as 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model with strata). Total number of non-vaccinated persons =211914.|PYAR|796.894||||||95.0|795.175|798.605|||Negative Binomial model with strata|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Antimicrobial Prescriptions recommended for AOM/RTI, number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any 10PN-PD-DIT vaccine - age stratum schedules).||798.605|795.175|
72519570|NCT00861380|144568626|OTHER|In 0 to 7 Years Old Population, in Year 2011, for Non-vaccinated persons living in study cluster areas, in which study participants received control vaccine, PYAR was calculated (= number of subjects reported with recommended Antimicrobial Prescriptions divided by sum of follow-up period expressed in years (per 1000), as well as 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model with strata). Total number of non-vaccinated persons =111071.|PYAR|803.918|||||TWO_SIDED|95.0|801.571|806.25|||Negative Binomial model with strata|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Antimicrobial Prescriptions recommended for AOM/RTI, number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any control (HAV or HBV) vaccine - age stratum schedules).||806.250|801.571|
72624943|NCT02757768|144779448|SUPERIORITY||LS Mean of Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.2||0.288|TWO_SIDED|95.0|-0.7|0.2|||ANCOVA|||EoT Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||0.2|-0.7|0.288
72519571|NCT00861380|144568626|OTHER|In 0 to 7 Years Old Population, in Year 2012, for Non-vaccinated persons living in study cluster areas, in which study participants received 10Pn-PD-DiT vaccine, PYAR was calculated (= number of subjects reported with Antimicrobial Prescriptions divided by sum of follow-up period expressed in years (per 1000), as well as 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model with strata). Total number of non-vaccinated persons =213913.|PYAR|865.679|||||TWO_SIDED|95.0|864.227|867.121|||Negative Binomial model with strata|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Antimicrobial Prescriptions, number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any 10PN-PD-DIT vaccine - age stratum schedules).||867.121|864.227|
72519572|NCT00861380|144568626|OTHER|In 0 to 7 Years Old Population, in Year 2012, for Non-vaccinated persons living in study cluster areas, in which study participants received control vaccine, PYAR was calculated (= number of subjects reported with Antimicrobial Prescriptions divided by sum of follow-up period expressed in years (per 1000), as well as 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model with strata). Total number of non-vaccinated persons =111414.|PYAR|871.749|||||TWO_SIDED|95.0|869.771|873.707|||Negative Binomial model with strata|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Antimicrobial Prescriptions, number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any control (HAV or HBV) vaccine - age stratum schedules).||873.707|869.771|
72519573|NCT00861380|144568626|OTHER|In 0 to 7 Years Old Population, in Year 2012, for Non-vaccinated persons living in study cluster areas, in which study participants received 10Pn-PD-DiT vaccine, PYAR was calculated (= number of subjects reported with recommended Antimicrobial Prescriptions divided by sum of follow-up period expressed in years (per 1000), as well as 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model with strata). Total number of non-vaccinated persons =213913.|PYAR|753.423|||||TWO_SIDED|95.0|751.591|755.249|||Negative Binomial model with strata|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Antimicrobial Prescriptions recommended for AOM/RTI, number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any 10PN-PD-DIT vaccine - age stratum schedules).||755.249|751.591|
72519574|NCT00861380|144568626|OTHER|In 0 to 7 Years Old Population, in Year 2012, for Non-vaccinated persons living in study cluster areas, in which study participants received control vaccine, PYAR was calculated (= number of subjects reported with recommended Antimicrobial Prescriptions divided by sum of follow-up period expressed in years (per 1000), as well as 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model with strata). Total number of non-vaccinated persons =111414.|PYAR|755.542|||||TWO_SIDED|95.0|753.008|758.064|||Negative Binomial model with strata|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Antimicrobial Prescriptions recommended for AOM/RTI, number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any control (HAV or HBV) vaccine - age stratum schedules).||758.064|753.008|
72519575|NCT00637377|144568645|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin is set to 10. The power is 90 % according to the sample size estimation of the study protocol.|Risk Difference (RD)|-1.2|||||TWO_SIDED|95.0|-4.86|2.46|||||The difference is calculated as Ranibizumab minus Aflibercept. A negative value favors the Aflibercept 2mg Q4 group. As adjustment of multiple comparisons a conditional sequence of statistical hypotheses is used with alpha = 0.05.|null hypothesis: pi ≤ pc-delta where pi is the probability that a participant maintained vision at week 52 under Aflibercept 2mg Q4, pc is the probability that a participant maintained vision at week 52 under Ranibizumab 0.5mg Q4 and delta is the non-inferiority margin. The null hypothesis is tested calculating a two-sided 95 % confidence using normal approximation of the difference of percentages of participants maintaining vision at week 52 (Ranibizumab 0.5mg Q4 minus Aflibercept 2mg Q4).||2.46|-4.86|
72542497|NCT04428502|144614775|EQUIVALENCE|Hypothesis tested was to evaluate that there is no difference in response between ACCP positive and ACCP negative PsA participants who were treated with etanercept.||||||0.6|||||||Student's t-test|||At Month 1: P-value \<0.05 was considered statistically significant, without multiplicity adjustment.||||0.6
72542498|NCT04428502|144614775|EQUIVALENCE|Hypothesis tested was to evaluate that there is no difference in response between ACCP positive and ACCP negative PsA participants who were treated with etanercept.||||||0.007|||||||Student's t-test|||At Month 6: P-value \<0.05 was considered statistically significant, without multiplicity adjustment.||||0.007
72624944|NCT02757768|144779449|SUPERIORITY||LS Mean of Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.1||0.128|TWO_SIDED|95.0|-0.3|0.0|||ANCOVA|||Week 4 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||0.0|-0.3|0.128
72405639|NCT04649151|144319526|NON_INFERIORITY|The noninferiority of Geometric Mean value (based on geometric least squares means \[GLSM\]) was considered demonstrated if: The lower bound of the 95% confidence interval (CI) of the geometric mean ratio (GMR) was \>0.667 based on the noninferiority margin of 1.5, and the GMR point estimate ≥0.8 (minimum threshold).|GMR|1.078|||||TWO_SIDED|95.0|0.94|1.237|||||GMR of P203 vs P301|||1.237|0.940|
72405640|NCT04649151|144319527|NON_INFERIORITY|Noninferiority margin of 10%. Lower bound of the 95% CI of the SRR difference \>-10%. and a point estimator \>-5% (minimum threshold)|percentage difference|-0.2|||||TWO_SIDED|95.0|-2.1|1.9|||||SRR difference of P203 vs P301|||1.9|-2.1|
72405641|NCT04649151|144319528|NON_INFERIORITY|The lower bound of the 95% CI of noninferiority margin of 1.5. GMR point estimate \>=0.8 (minimum threshold).|GMR|5.071|||||TWO_SIDED|95.0|4.477|5.745|||||GMR of GMC at BD-Day 29 P203 vs GMC at Day 57 P301|||5.745|4.477|
72405642|NCT04649151|144319529|NON_INFERIORITY|Noninferiority margin of 10%. Lower bound of the 95% CI of the SRR difference \>-10%.|SRR Difference|0.7|||||TWO_SIDED|95.0|-0.8|2.4|||||SRR difference of P203 BD-Day 29 vs P301 Day 57|||2.4|-0.8|
72519576|NCT00637377|144568645|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin is set to 10. The power is 90 % according to the sample size estimation of the study protocol.|Risk Difference (RD)|-1.84|||||TWO_SIDED|95.0|-5.4|1.71|||||The difference is calculated as Ranibizumab minus Aflibercept. A negative value favors the Aflibercept 0.5mg Q4 group. As adjustment of multiple comparisons a conditional sequence of statistical hypotheses is used with alpha = 0.05.|null hypothesis: pi ≤ pc-delta where pi is the probability that a participant maintained vision at week 52 under Aflibercept 0.5mg Q4, pc is the probability that a participant maintained vision at week 52 under Ranibizumab 0.5mg Q4 and delta is the non-inferiority margin. The null hypothesis is tested calculating a two-sided 95 % confidence using normal approximation of the difference of percentages of participants maintaining vision at week 52 (Ranibizumab 0.5mg Q4 minus Aflibercept 0.5mg Q4).||1.71|-5.40|
72519577|NCT00637377|144568645|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin is set to 10. The power is 90 % according to the sample size estimation of the study protocol.|Risk Difference (RD)|-1.13|||||TWO_SIDED|95.0|-4.81|2.55|||||The difference is calculated as Ranibizumab minus Aflibercept. A negative value favors the Aflibercept 2mg Q8 group. As adjustment of multiple comparisons a conditional sequence of statistical hypotheses is used with alpha = 0.05.|null hypothesis: pi ≤ pc-delta where pi is the probability that a participant maintained vision at week 52 under Aflibercept 2mg Q8, pc is the probability that a participant maintained vision at week 52 under Ranibizumab 0.5mg Q4 and delta is the non-inferiority margin. The null hypothesis is tested calculating a two-sided 95 % confidence using normal approximation of the difference of percentages of participants maintaining vision at week 52 (Ranibizumab 0.5mg Q4 minus Aflibercept 2mg Q8).||2.55|-4.81|
72519578|NCT00637377|144568646|SUPERIORITY_OR_OTHER||Differences in Least Squares means|-1.9484||||0.076|TWO_SIDED|95.0|-4.1009|0.204||as adjustment of multiple comparisons a conditional sequence of statistical hypotheses (a-priori ordered hypotheses) is used with alpha = 0.05.|ANCOVA||The difference is calculated as Aflibercept minus Ranibizumab. A positive value favors Aflibercept 2mg Q4.|The pairwise comparison is performed as contrast statement in the analysis of covariance model with treatment group as fixed factor (all 4 treatment groups) and the baseline ETDRS letter score as covariate. The null hypothesis is that both mean changes are equal.||0.2040|-4.1009|0.076
72519579|NCT00637377|144568646|SUPERIORITY_OR_OTHER||Differences in Least Squares means|-0.062||||0.9555|TWO_SIDED|95.0|-2.2398|2.1158||as adjustment of multiple comparisons a conditional sequence of statistical hypotheses (a-priori ordered hypotheses) is used with alpha = 0.05.|ANCOVA||The difference is calculated as Aflibercept minus Ranibizumab. A positive value favors Aflibercept 0.5mg Q4|The pairwise comparison is performed as contrast statement in the analysis of covariance model with treatment group as fixed factor (all 4 treatment groups) and the baseline ETDRS letter score as covariate. The null hypothesis is that both mean changes are equal.||2.1158|-2.2398|0.9555
72519580|NCT00637377|144568646|SUPERIORITY_OR_OTHER||Differences in Least Squares means|-0.9014||||0.4131|TWO_SIDED|95.0|-3.0615|1.2587||as adjustment of multiple comparisons a conditional sequence of statistical hypotheses (a-priori ordered hypotheses) is used with alpha = 0.05.|ANCOVA||The difference is calculated as Aflibercept minus Ranibizumab. A positive value favors the Aflibercept 2mg Q8 group|The pairwise comparison is performed as contrast statement in the analysis of covariance model with treatment group as fixed factor (all 4 treatment groups) and the baseline ETDRS letter score as covariate. The null hypothesis is that both mean changes are equal.||1.2587|-3.0615|0.4131
72519581|NCT00637377|144568647|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-4.57||||0.229|TWO_SIDED|95.0|-12.02|2.88||as adjustment of multiple comparisons a conditional sequence of statistical hypotheses (a-priori ordered hypotheses) is used with alpha = 0.05.|Chi-squared||The difference is calculated as Aflibercept minus Ranibizumab. A positive value favors the Aflibercept 2mg Q4 group|The null hypothesis is that the two proportions are equal.||2.88|-12.02|0.229
72519582|NCT00637377|144568647|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.78||||0.843|TWO_SIDED|95.0|-6.91|8.46||as adjustment of multiple comparisons a conditional sequence of statistical hypotheses (a-priori ordered hypotheses) is used with alpha = 0.05.|Chi-squared||The difference is calculated as Aflibercept minus Ranibizumab. A positive value favors the Aflibercept 0.5mg Q4 group|The null hypothesis is that the two proportions are equal.||8.46|-6.91|0.843
72519583|NCT00637377|144568647|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-2.65||||0.49|TWO_SIDED|95.0|-10.18|4.88||as adjustment of multiple comparisons a conditional sequence of statistical hypotheses (a-priori ordered hypotheses) is used with alpha = 0.05.|Chi-squared||The difference is calculated as Aflibercept minus Ranibizumab. A positive value favors the Aflibercept 2mg Q8 group|The null hypothesis is that the two proportions are equal.||4.88|-10.18|0.490
72519584|NCT00637377|144568648|SUPERIORITY_OR_OTHER||Differences in Least Squares means|-2.7885||||0.0097|TWO_SIDED|95.0|-4.9012|-0.6757||as adjustment of multiple comparisons a conditional sequence of statistical hypotheses (a-priori ordered hypotheses) is used with alpha = 0.05.|ANCOVA||The difference is calculated as Aflibercept minus Ranibizumab. A positive value favors Aflibercept 2mg Q4.|The pairwise comparison is performed as contrast statement in the analysis of covariance model with treatment group as fixed factor (all 4 treatment groups) and the baseline NEI VFQ-25 total score as covariate. The null hypothesis is that both mean changes are equal.||-0.6757|-4.9012|0.0097
72519585|NCT00637377|144568648|SUPERIORITY_OR_OTHER||Differences in Least Squares means|-0.932||||0.3917|TWO_SIDED|95.0|-3.0658|1.2019||as adjustment of multiple comparisons a conditional sequence of statistical hypotheses (a-priori ordered hypotheses) is used with alpha = 0.05.|ANCOVA||The difference is calculated as Aflibercept minus Ranibizumab. A positive value favors Aflibercept 0.5mg Q4.|The pairwise comparison is performed as contrast statement in the analysis of covariance model with treatment group as fixed factor (all 4 treatment groups) and the baseline NEI VFQ-25 total score as covariate. The null hypothesis is that both mean changes are equal.||1.2019|-3.0658|0.3917
72542499|NCT04428502|144614775|EQUIVALENCE|Hypothesis tested was to evaluate that there is no difference in response between ACCP positive and ACCP negative PsA participants who were treated with etanercept.||||||0.004|||||||Student's t-test|||At Month 12: P-value \<0.05 was considered statistically significant, without multiplicity adjustment.||||0.004
72405643|NCT04649151|144319530|SUPERIORITY|The superiority of GMC (based on GLSM\] was considered demonstrated if: The lower bound of the 95% CI of the GMR was \>1|GMR|48.191|||||TWO_SIDED|95.0|43.765|53.065|||||GMR of P203 vs P301|||53.065|43.765|
72405644|NCT04649151|144319533|NON_INFERIORITY|The noninferiority of Geometric Mean value (based on GLSM) was considered demonstrated if: The lower bound of the 95% CI of the GMR was \>0.667 based on the noninferiority margin of 1.5, and the GMR point estimate ≥0.8 (minimum threshold).|GMR|4.493|||||TWO_SIDED|95.0|3.972|5.083|||||GMR of GMC at BD-Day 29 P203 vs GMC at Day 57 P301|||5.083|3.972|
72405645|NCT04649151|144319536|OTHER|The 95% CI of the ratio was calculated using the exact method conditional upon the total number of cases, adjusting for person-years.|VE|60.3|||||TWO_SIDED|95.0|26.6|78.6|||VE|Vaccine efficacy (VE, percent), was defined as 1 - ratio of incidence rate (mRNA-1273 vs. placebo).||||78.6|26.6|
72405646|NCT04649151|144319537|OTHER|The 95% CI of the ratio was calculated using the exact method conditional upon the total number of cases, adjusting for person-years.|VE|43.5|||||TWO_SIDED|95.0|-16.5|72.2|||VE|VE (percent), was defined as 1 - ratio of incidence rate (mRNA-1273 vs. placebo).||||72.2|-16.5|
72519586|NCT00637377|144568648|SUPERIORITY_OR_OTHER||Differences in Least Squares means|-1.947||||0.0717|TWO_SIDED|95.0|-4.0659|0.1718||as adjustment of multiple comparisons a conditional sequence of statistical hypotheses (a-priori ordered hypotheses) is used with alpha = 0.05.|ANCOVA||The difference is calculated as Aflibercept minus Ranibizumab. A positive value favors Aflibercept 2mg Q8.|The pairwise comparison is performed as contrast statement in the analysis of covariance model with treatment group as fixed factor (all 4 treatment groups) and the baseline NEI VFQ-25 total score as covariate. The null hypothesis is that both mean changes are equal.||0.1718|-4.0659|0.0717
72519587|NCT00637377|144568649|SUPERIORITY_OR_OTHER||Differences in Least Squares means|-1.18||||0.0038|TWO_SIDED|95.0|-1.979|-0.382||as adjustment of multiple comparisons a conditional sequence of statistical hypotheses (a-priori ordered hypotheses) is used with alpha = 0.05.|ANCOVA||The difference is calculated as Aflibercept minus Ranibizumab. A negative value favors Aflibercept 2mg Q4.|The pairwise comparison is performed as contrast statement in the analysis of covariance model with treatment group as fixed factor (all 4 treatment groups) and the baseline CNV area as covariate. The null hypothesis is that both mean changes are equal.||-0.382|-1.979|0.0038
72519588|NCT00637377|144568649|SUPERIORITY_OR_OTHER||Differences in Least Squares means|0.17||||0.6784|TWO_SIDED|95.0|-0.632|0.972||as adjustment of multiple comparisons a conditional sequence of statistical hypotheses (a-priori ordered hypotheses) is used with alpha = 0.05.|ANCOVA||The difference is calculated as Aflibercept minus Ranibizumab. A negative value favors Aflibercept 0.5mg Q4.|The pairwise comparison is performed as contrast statement in the analysis of covariance model with treatment group as fixed factor (all 4 treatment groups) and the baseline CNV area as covariate. The null hypothesis is that both mean changes are equal.||0.972|-0.632|0.6784
72519589|NCT00637377|144568649|SUPERIORITY_OR_OTHER||Differences in Least Squares means|-0.733||||0.0727|TWO_SIDED|95.0|-1.534|0.068||as adjustment of multiple comparisons a conditional sequence of statistical hypotheses (a-priori ordered hypotheses) is used with alpha = 0.05.|ANCOVA||The difference is calculated as Aflibercept minus Ranibizumab. A negative value favors Aflibercept 2mg Q8.|The pairwise comparison is performed as contrast statement in the analysis of covariance model with treatment group as fixed factor (all 4 treatment groups) and the baseline CNV area as covariate. The null hypothesis is that both mean changes are equal.||0.068|-1.534|0.0727
72519590|NCT01938001|144568650|SUPERIORITY||Hazard Ratio (HR)|0.46|||<|0.0001|TWO_SIDED|95.0|0.34|0.62|||Log Rank|Stratified by 3 factors: previous rituximab treatment, time since last antilymphoma therapy (≤ 2, \> 2 years), and disease histology (FL, MZL).|Hazard ratio and its confidence interval (CI) were estimated from Cox proportional hazard model adjusting for the stratification factors noted above.|||0.62|0.34|< 0.0001
72519591|NCT01938001|144568651|SUPERIORITY|||||||0.0006|||||||Cochran-Mantel-Haenszel|Stratified by 3 factors: previous rituximab treatment, time since last antilymphoma therapy (≤ 2, \> 2 years), and disease histology (FL, MZL).||||||0.0006
72519592|NCT01938001|144568652|SUPERIORITY||Hazard Ratio (HR)|0.59|||||TWO_SIDED|95.0|0.37|0.95||||||Stratified by 3 factors: previous rituximab treatment, time since last antilymphoma therapy (≤ 2, \> 2 years), and disease histology (FL, MZL).||0.95|0.37|
72519593|NCT01938001|144568653|SUPERIORITY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|Stratified by 3 factors: previous rituximab treatment, time since last antilymphoma therapy (≤ 2, \> 2 years), and disease histology (FL, MZL).||||||< 0.0001
72519594|NCT01938001|144568654|SUPERIORITY||||||=|0.001|||||||Cochran-Mantel-Haenszel|Stratified by 3 factors: previous rituximab treatment, time since last antilymphoma therapy (≤ 2, \> 2 years), and disease histology (FL, MZL).||||||= 0.0010
72519595|NCT01938001|144568655|SUPERIORITY||Hazard Ratio (HR)|0.53||||0.0015|TWO_SIDED|95.0|0.36|0.79|||Log Rank|||||0.79|0.36|0.0015
72405647|NCT04649151|144319538|OTHER||VE|100.0|||||TWO_SIDED|95.0|61.2||NA = not estimable (not reached).||VE|VE (percent), was defined as 1 - ratio of incidence rate (mRNA-1273 vs. placebo).|The 95% CI of the ratio was calculated using the exact method conditional upon the total number of cases, adjusting for person-years.||||61.2|
72405648|NCT04649151|144319539|OTHER|The 95% CI of the ratio was calculated using the exact method conditional upon the total number of cases, adjusting for person-years.|VE|89.9|||||TWO_SIDED|95.0|51.0|98.9|||VE|VE (percent), was defined as 1 - ratio of incidence rate (mRNA-1273 vs. placebo).||||98.9|51.0|
72519596|NCT01938001|144568656|SUPERIORITY||Hazard Ratio (HR)|0.68||||0.2993|TWO_SIDED|95.0|0.32|1.43|||Log Rank|||||1.43|0.32|0.2993
72519597|NCT01938001|144568657|SUPERIORITY||Hazard Ratio (HR)|0.51|||<|0.0001|TWO_SIDED|95.0|0.38|0.67|||Stratified Log-Rank Test|Stratified by 3 factors: previous rituximab treatment, time since last antilymphoma therapy (≤ 2, \> 2 years), and disease histology (FL, MZL).|Hazard ratio and its CI were estimated from Cox proportional hazard model adjusting for the stratification factors noted above.|||0.67|0.38|< 0.0001
72519598|NCT01938001|144568658|SUPERIORITY||Hazard Ratio (HR)|0.53|||<|0.0001|TWO_SIDED|95.0|0.39|0.71|||Stratified Log Rank Test|Stratified by 3 factors: previous rituximab treatment, time since last antilymphoma therapy (≤ 2, \> 2 years), and disease histology (FL, MZL).||||0.71|0.39|<0.0001
72519599|NCT01062009|144568680|SUPERIORITY_OR_OTHER_LEGACY|||||||0.24|TWO_SIDED||||||Chi-squared|||Chi square analysis comparing number of participants with new fever in each group||||0.24
72519600|NCT01468701|144568683|OTHER||Hazard Ratio (HR)|0.74|||||TWO_SIDED|95.0|0.6|0.9|||Regression, Cox||Hazard ratio of dabigatran versus vitamin K antagonist (vitamin K antagonist as reference).|A multivariable Cox regression model was performed including variables of treatment, age, gender, prior bleed, previous stroke/transient ischaemic attack/systemic embolism, previous myocardial infarction, abnormal kidney function and concomitant antiplatelets use.||0.90|0.60|
72519601|NCT01468701|144568685|OTHER||Hazard Ratio (HR)|0.79|||||TWO_SIDED|95.0|0.63|0.98|||Regression, Cox||Hazard ratio of dabigatran versus vitamin K antagonist (vitamin K antagonist as reference).|A multivariable Cox regression model was performed including variables of treatment, age, gender, prior bleed, previous stroke/transient ischaemic attack/systemic embolism, previous myocardial infarction, abnormal kidney function and concomitant antiplatelets use.||0.98|0.63|
72519602|NCT01468701|144568686|OTHER||Hazard Ratio (HR)|0.79|||||TWO_SIDED|95.0|0.57|1.11|||Regression, Cox||Hazard ratio of dabigatran versus vitamin K antagonist (vitamin K antagonist as reference).|A multivariable Cox regression model was performed including variables of treatment, age, gender, prior bleed, previous stroke/transient ischaemic attack/systemic embolism, previous myocardial infarction, abnormal kidney function and concomitant antiplatelets use.||1.11|0.57|
72519603|NCT01468701|144568688|OTHER||Hazard Ratio (HR)|0.81|||||TWO_SIDED|95.0|0.57|1.14|||Regression, Cox||Hazard ratio of dabigatran versus vitamin K antagonist (vitamin K antagonist as reference).|A multivariable Cox regression model was performed including variables of treatment, age, gender, prior bleed, previous stroke/transient ischaemic attack/systemic embolism, previous myocardial infarction, abnormal kidney function and concomitant antiplatelets use.||1.14|0.57|
72519604|NCT01468701|144568696|OTHER||Hazard Ratio (HR)|0.52|||||TWO_SIDED|95.0|0.38|0.73|||Regression, Cox||Hazard ratio of dabigatran versus vitamin K antagonist (vitamin K antagonist as reference).|A multivariable Cox regression model was performed including variables of treatment, age, gender, prior bleed, previous myocardial infarction, abnormal kidney function, concomitant antiplatelets use and concomitant use of drugs related to bleeding.||0.73|0.38|
72519605|NCT01468701|144568700|OTHER||Hazard Ratio (HR)|0.97|||||TWO_SIDED|95.0|0.6|1.57|||Regression, Cox||Hazard ratio of dabigatran versus vitamin K antagonist (vitamin K antagonist as reference).|A multivariable Cox regression model was performed including variables of treatment, age, gender, prior bleed, previous myocardial infarction, concomitant antiplatelets use, concomitant use of drugs related to bleeding, hypertension, and diabetes.||1.57|0.60|
72519606|NCT01468701|144568702|OTHER||Hazard Ratio (HR)|0.66|||||TWO_SIDED|95.0|0.54|0.8|||Regression, Cox||Hazard ratio of dabigatran versus vitamin K antagonist (vitamin K antagonist as reference).|A multivariable Cox regression model was performed including variables of treatment, age, gender, prior bleed, previous stroke/transient ischaemic attack/systemic embolism, previous myocardial infarction, abnormal kidney function and concomitant antiplatelets use.||0.80|0.54|
72405649|NCT03907683|144319554|SUPERIORITY||Mean Difference (Final Values)|0.16412|STANDARD_ERROR_OF_MEAN|0.08||0.037|TWO_SIDED|95.0|0.0098|0.3185|||t-test, 2 sided|||Null hypothesis was that the mean steady state response to weekday move more messages would not differ from zero||0.3185|.0098|0.037
72405650|NCT03907683|144319554|SUPERIORITY||Mean Difference (Net)|0.12538|STANDARD_ERROR_OF_MEAN|0.07674||0.106|TWO_SIDED|95.0|-0.0274|0.2781|||t-test, 2 sided|||Null hypothesis was that the mean steady state response to weekday sit less messages would not differ from zero||0.2781|-0.0274|.106
72569708|NCT02944383|144669990|SUPERIORITY|||||||0.4639||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.4639
72519607|NCT01068717|144568705|NON_INFERIORITY_OR_EQUIVALENCE|Point estimates and 90% confidence intervals (CIs) were calculated for Treatment B to Treatment A and Treatment D to Treatment C ratios of geometric means for Cmax, AUC(INF), and AUC(0-T) of saxagliptin and metformin, respectively. Potency-corrected results were also provided. Bioequivalence will be concluded if the 90% CIs for the test-to-reference ratios of geometric means are entirely contained within 80% to 125% for both Cmax and AUC(INF). No adjustments were made for multiplicity.|Ratio geometric least squares (LS) mean|109.53|||||TWO_SIDED|90.0|102.67|116.85||||||To demonstrate the bioequivalence of FDC tablet versus coadministration of saxagliptin and metformin tablets in the fasted and fed states, linear mixed model analyses were performed on log(Cmax), log\[AUC(INF)\], and log\[AUC(0-T)\] of saxagliptin and metformin, respectively. The factors in the model were sequence, period, and treatment as fixed effects and measurements within each subject as repeated measurements allowing for different covariance structures for the fasted and fed states.||116.85|102.67|
72519608|NCT01068717|144568705|NON_INFERIORITY_OR_EQUIVALENCE|Point estimates and 90% confidence intervals (CIs) were calculated for Treatment B to Treatment A and Treatment D to Treatment C ratios of geometric means for Cmax, AUC(INF), and AUC(0-T) of saxagliptin and metformin, respectively. Potency-corrected results were also provided. Bioequivalence will be concluded if the 90% CIs for the test-to-reference ratios of geometric means are entirely contained within 80% to 125% for both Cmax and AUC(INF). No adjustments were made for multiplicity.|Ratio geometric LS mean|100.37|||||TWO_SIDED|90.0|85.7|117.56||||||To demonstrate the bioequivalence of FDC tablet versus coadministration of saxagliptin and metformin tablets in the fasted and fed states, linear mixed model analyses were performed on log(Cmax), log\[AUC(INF)\], and log\[AUC(0-T)\] of saxagliptin and metformin, respectively. The factors in the model were sequence, period, and treatment as fixed effects and measurements within each subject as repeated measurements allowing for different covariance structures for the fasted and fed states.||117.56|85.70|
72542500|NCT00449930|144614780|NON_INFERIORITY_OR_EQUIVALENCE|The pre-specified non-inferiority margin was 0.4%; i.e., non-inferiority required that the upper boundary of the 95% confidence interval for the treatment difference (sitagliptin minus metformin) to be less than 0.4%.|Mean Difference (Net)|0.14|STANDARD_DEVIATION|0.57||||95.0|0.06|0.21|||||Based on an analysis of covariance (ANCOVA) model with terms for treatment group and baseline value.|||0.21|0.06|
72405651|NCT03907683|144319554|SUPERIORITY||Mean Difference (Net)|0.24738|STANDARD_ERROR_OF_MEAN|0.13746||0.076|TWO_SIDED|95.0|-0.0262|0.521|||t-test, 2 sided|||Null hypothesis was that the mean steady state response to weekday inspirational quote messages would not differ from zero||.5210|-.0262|.076
72405652|NCT03907683|144319554|SUPERIORITY||Mean Difference (Net)|0.30563|STANDARD_ERROR_OF_MEAN|0.16136||0.062|TWO_SIDED|95.0|-0.0156|0.6268|||t-test, 2 sided|||Null hypothesis was that the mean steady state response to weekend move more messages would not differ from zero||.6268|-.0156|.062
72542501|NCT00449930|144614781|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-7.3|||<|0.001||95.0|-10.6|-4.2|||Fisher Exact||"Difference (sitagliptin minus metformin) in the percentage of patients with diarrhea.~Wilson Score method was used for the 95% Confidence Interval (CI)."|||-4.2|-10.6|<0.001
72569709|NCT02944383|144669990|SUPERIORITY|||||||0.021||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||EOS (average of week 10 and 12)||||0.0210
72624945|NCT02757768|144779449|SUPERIORITY||LS Mean of Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.1||0.054|TWO_SIDED|95.0|-0.4|0.0|||ANCOVA|||Week 8 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||0.0|-0.4|0.054
72624946|NCT02757768|144779449|SUPERIORITY||LS Mean of Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.1||0.079|TWO_SIDED|95.0|-0.4|0.0|||ANCOVA|||Week 12 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||0.0|-0.4|0.079
72624947|NCT02757768|144779449|SUPERIORITY||LS Mean of Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.1||0.148|TWO_SIDED|95.0|-0.4|0.1|||ANCOVA|||EoT Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||0.1|-0.4|0.148
72519609|NCT01068717|144568706|NON_INFERIORITY_OR_EQUIVALENCE|Point estimates and 90% confidence intervals (CIs) were calculated for Treatment B to Treatment A and Treatment D to Treatment C ratios of geometric means for Cmax, AUC(INF), and AUC(0-T) of saxagliptin and metformin, respectively. Potency-corrected results were also provided. Bioequivalence will be concluded if the 90% CIs for the test-to-reference ratios of geometric means are entirely contained within 80% to 125% for both Cmax and AUC(INF). No adjustments were made for multiplicity.|Ratio geometric LS mean|99.02|||||TWO_SIDED|90.0|91.29|107.41||||||To demonstrate the bioequivalence of FDC tablet versus coadministration of saxagliptin and metformin tablets in the fasted and fed states, linear mixed model analyses were performed on log(Cmax), log\[AUC(INF)\], and log\[AUC(0-T)\] of saxagliptin and metformin, respectively. The factors in the model were sequence, period, and treatment as fixed effects and measurements within each subject as repeated measurements allowing for different covariance structures for the fasted and fed states||107.41|91.29|
72519610|NCT01068717|144568706|NON_INFERIORITY_OR_EQUIVALENCE|Point estimates and 90% confidence intervals (CIs) were calculated for Treatment B to Treatment A and Treatment D to Treatment C ratios of geometric means for Cmax, AUC(INF), and AUC(0-T) of saxagliptin and metformin, respectively. Potency-corrected results were also provided. Bioequivalence will be concluded if the 90% CIs for the test-to-reference ratios of geometric means are entirely contained within 80% to 125% for both Cmax and AUC(INF). No adjustments were made for multiplicity.|Ratio geometric LS mean|100.21|||||TWO_SIDED|90.0|96.86|103.67||||||To demonstrate the bioequivalence of FDC tablet versus coadministration of saxagliptin and metformin tablets in the fasted and fed states, linear mixed model analyses were performed on log(Cmax), log\[AUC(INF)\], and log\[AUC(0-T)\] of saxagliptin and metformin, respectively. The factors in the model were sequence, period, and treatment as fixed effects and measurements within each subject as repeated measurements allowing for different covariance structures for the fasted and fed states.||103.67|96.86|
72519611|NCT01068717|144568708|NON_INFERIORITY_OR_EQUIVALENCE|Point estimates and 90% confidence intervals (CIs) were calculated for Treatment B to Treatment A and Treatment D to Treatment C ratios of geometric means for Cmax, AUC(INF), and AUC(0-T) of saxagliptin and metformin, respectively. Potency-corrected results were also provided. Bioequivalence will be concluded if the 90% CIs for the test-to-reference ratios of geometric means are entirely contained within 80% to 125% for both Cmax and AUC(INF). No adjustments were made for multiplicity.|Ratio geometric LS mean|102.34|||||TWO_SIDED|90.0|97.96|106.91||||||To demonstrate the bioequivalence of FDC tablet versus coadministration of saxagliptin and metformin tablets in the fasted and fed states, linear mixed model analyses were performed on log(Cmax), log\[AUC(INF)\], and log\[AUC(0-T)\] of saxagliptin and metformin, respectively. The factors in the model were sequence, period, and treatment as fixed effects and measurements within each subject as repeated measurements allowing for different covariance structures for the fasted and fed states.||106.91|97.96|
72624948|NCT02757768|144779450|SUPERIORITY||LS Mean of Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.25||0.66|TWO_SIDED|95.0|-0.61|0.39|||ANCOVA|||Week 4 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||0.39|-0.61|0.660
72624949|NCT02757768|144779450|SUPERIORITY||LS Mean of Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.32||0.767|TWO_SIDED|95.0|-0.72|0.53|||ANCOVA|||Week 8 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||0.53|-0.72|0.767
72405653|NCT03907683|144319554|SUPERIORITY||Mean Difference (Net)|0.277|STANDARD_ERROR_OF_MEAN|0.10676||0.11|TWO_SIDED|95.0|0.0645|0.4895|||t-test, 2 sided|||Null hypothesis was that the mean steady state response to weekend sit less messages would not differ from zero||.4895|.0645|0.11
72405654|NCT03907683|144319554|SUPERIORITY||Mean Difference (Net)|0.10837|STANDARD_ERROR_OF_MEAN|0.16895||0.523|TWO_SIDED|95.0|-0.2279|0.4447|||t-test, 2 sided|||Null hypothesis was that the mean steady state response to weekend inspirational quote messages would not differ from zero||0.4447|-0.2279|.523
72624950|NCT02757768|144779450|SUPERIORITY||LS Mean of Difference|-0.28|STANDARD_ERROR_OF_MEAN|0.31||0.372|TWO_SIDED|95.0|-0.89|0.34|||ANCOVA|||Week 12 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||0.34|-0.89|0.372
72405655|NCT03400332|144319580|OTHER||Hazard Ratio, log|0.94||||0.7416|TWO_SIDED|95.0|0.61|1.45|||Log Rank|||||1.45|0.61|0.7416
72405656|NCT02704364|144319643|SUPERIORITY||Hodges-Lehmann estimate|-14.0|STANDARD_ERROR_OF_MEAN|21.4||0.434|TWO_SIDED|95.0|-68.0|28.0|||Wilcoxon (Mann-Whitney)|||||28.0|-68.0|0.434
72519612|NCT01068717|144568708|NON_INFERIORITY_OR_EQUIVALENCE|Point estimates and 90% confidence intervals (CIs) were calculated for Treatment B to Treatment A and Treatment D to Treatment C ratios of geometric means for Cmax, AUC(INF), and AUC(0-T) of saxagliptin and metformin, respectively. Potency-corrected results were also provided. Bioequivalence will be concluded if the 90% CIs for the test-to-reference ratios of geometric means are entirely contained within 80% to 125% for both Cmax and AUC(INF). No adjustments were made for multiplicity.|Ratio geometric LS mean|99.78|||||TWO_SIDED|90.0|96.61|103.05||||||To demonstrate the bioequivalence of FDC tablet versus coadministration of saxagliptin and metformin tablets in the fasted and fed states, linear mixed model analyses were performed on log(Cmax), log\[AUC(INF)\], and log\[AUC(0-T)\] of saxagliptin and metformin, respectively. The factors in the model were sequence, period, and treatment as fixed effects and measurements within each subject as repeated measurements allowing for different covariance structures for the fasted and fed states.||103.05|96.61|
72519613|NCT01068717|144568713|NON_INFERIORITY_OR_EQUIVALENCE|Point estimates and 90% confidence intervals (CIs) were calculated for Treatment B to Treatment A and Treatment D to Treatment C ratios of geometric means for Cmax, AUC(INF), and AUC(0-T) of saxagliptin and metformin, respectively. Potency-corrected results were also provided. Bioequivalence will be concluded if the 90% CIs for the test-to-reference ratios of geometric means are entirely contained within 80% to 125% for both Cmax and AUC(INF). No adjustments were made for multiplicity.|Ratio geometric LS mean|102.34|||||TWO_SIDED|90.0|97.96|106.91||||||To demonstrate the bioequivalence of FDC tablet versus coadministration of saxagliptin and metformin tablets in the fasted and fed states, linear mixed model analyses were performed on log(Cmax), log\[AUC(INF)\], and log\[AUC(0-T)\] of saxagliptin and metformin, respectively. The factors in the model were sequence, period, and treatment as fixed effects and measurements within each subject as repeated measurements allowing for different covariance structures for the fasted and fed states.||106.91|97.96|
72519614|NCT01068717|144568713|NON_INFERIORITY_OR_EQUIVALENCE|Point estimates and 90% confidence intervals (CIs) were calculated for Treatment B to Treatment A and Treatment D to Treatment C ratios of geometric means for Cmax, AUC(INF), and AUC(0-T) of saxagliptin and metformin, respectively. Potency-corrected results were also provided. Bioequivalence will be concluded if the 90% CIs for the test-to-reference ratios of geometric means are entirely contained within 80% to 125% for both Cmax and AUC(INF). No adjustments were made for multiplicity.|Ratio geometric LS mean|101.82|||||TWO_SIDED|90.0|96.1|107.88||||||To demonstrate the bioequivalence of FDC tablet versus coadministration of saxagliptin and metformin tablets in the fasted and fed states, linear mixed model analyses were performed on log(Cmax), log\[AUC(INF)\], and log\[AUC(0-T)\] of saxagliptin and metformin, respectively. The factors in the model were sequence, period, and treatment as fixed effects and measurements within each subject as repeated measurements allowing for different covariance structures for the fasted and fed states.||107.88|96.10|
72519615|NCT01068717|144568714|NON_INFERIORITY_OR_EQUIVALENCE|Point estimates and 90% confidence intervals (CIs) were calculated for Treatment B to Treatment A and Treatment D to Treatment C ratios of geometric means for Cmax, AUC(INF), and AUC(0-T) of saxagliptin and metformin, respectively. Potency-corrected results were also provided. Bioequivalence will be concluded if the 90% CIs for the test-to-reference ratios of geometric means are entirely contained within 80% to 125% for both Cmax and AUC(INF). No adjustments were made for multiplicity.|Ratio (%) of geometric LS mean|102.64|||||TWO_SIDED|90.0|98.31|107.16||||||To demonstrate the bioequivalence of FDC tablet versus coadministration of saxagliptin and metformin tablets in the fasted and fed states, linear mixed model analyses were performed on log(Cmax), log\[AUC(INF)\], and log\[AUC(0-T)\] of saxagliptin and metformin, respectively. The factors in the model were sequence, period, and treatment as fixed effects and measurements within each subject as repeated measurements allowing for different covariance structures for the fasted and fed states.||107.16|98.31|
72519616|NCT01068717|144568714|NON_INFERIORITY_OR_EQUIVALENCE|Point estimates and 90% confidence intervals (CIs) were calculated for Treatment B to Treatment A and Treatment D to Treatment C ratios of geometric means for Cmax, AUC(INF), and AUC(0-T) of saxagliptin and metformin, respectively. Potency-corrected results were also provided. Bioequivalence will be concluded if the 90% CIs for the test-to-reference ratios of geometric means are entirely contained within 80% to 125% for both Cmax and AUC(INF). No adjustments were made for multiplicity.|Ratio (%) of geometric LS mean|99.22||||||90.0|96.48|102.04||||||To demonstrate the bioequivalence of FDC tablet versus coadministration of saxagliptin and metformin tablets in the fasted and fed states, linear mixed model analyses were performed on log(Cmax), log\[AUC(INF)\], and log\[AUC(0-T)\] of saxagliptin and metformin, respectively. The factors in the model were sequence, period, and treatment as fixed effects and measurements within each subject as repeated measurements allowing for different covariance structures for the fasted and fed states.||102.04|96.48|
72519617|NCT01068717|144568715|NON_INFERIORITY_OR_EQUIVALENCE|Point estimates and 90% confidence intervals (CIs) were calculated for Treatment B to Treatment A and Treatment D to Treatment C ratios of geometric means for Cmax, AUC(INF), and AUC(0-T) of saxagliptin and metformin, respectively. Potency-corrected results were also provided. Bioequivalence will be concluded if the 90% CIs for the test-to-reference ratios of geometric means are entirely contained within 80% to 125% for both Cmax and AUC(INF). No adjustments were made for multiplicity.|Ratio geometric LS mean|99.04|||||TWO_SIDED|95.0|92.9|105.59||||||To demonstrate the bioequivalence of FDC tablet versus coadministration of saxagliptin and metformin tablets in the fasted and fed states, linear mixed model analyses were performed on log(Cmax), log\[AUC(INF)\], and log\[AUC(0-T)\] of saxagliptin and metformin, respectively. The factors in the model were sequence, period, and treatment as fixed effects and measurements within each subject as repeated measurements allowing for different covariance structures for the fasted and fed states.||105.59|92.90|
72624951|NCT02757768|144779450|SUPERIORITY||LS Mean of Difference|-0.33|STANDARD_ERROR_OF_MEAN|0.3||0.272|TWO_SIDED|95.0|-0.92|0.26|||ANCOVA|||EoT Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||0.26|-0.92|0.272
72405657|NCT02704364|144319643|SUPERIORITY||Hodges-Lehmann estimate|13.0|STANDARD_ERROR_OF_MEAN|25.0||0.646|TWO_SIDED|95.0|-41.0|71.0|||Wilcoxon (Mann-Whitney)|||||71.0|-41.0|0.646
72405658|NCT02975934|144319661|SUPERIORITY||Hazard Ratio (HR)|0.5|||<|0.001|TWO_SIDED|95.0|0.36|0.69|||Log Rank|||||0.69|0.36|<0.001
72405659|NCT02975934|144319662|SUPERIORITY||Hazard Ratio (HR)|0.61|||<|0.001|TWO_SIDED|95.0|0.47|0.8|||Log Rank|||||0.80|0.47|<0.001
72405660|NCT02975934|144319663|SUPERIORITY||Hazard Ratio (HR)|0.91||||0.5044|TWO_SIDED|95.0|0.68|1.2|||Log Rank|||||1.20|0.68|0.5044
72405661|NCT02975934|144319664|SUPERIORITY||Hazard Ratio (HR)|0.99||||0.9368|TWO_SIDED|95.0|0.78|1.26|||Log Rank|||||1.26|0.78|0.9368
72405662|NCT02075840|144319692|SUPERIORITY||Hazard Ratio, stratified|0.47|||<|0.0001|TWO_SIDED|95.0|0.34|0.65|||Log Rank|||Stratified hazard ratio and p-value are stratified for covariates Race (Asian vs Non-Asian) and CNS metastases at baseline by IRC.||0.65|0.34|<0.0001
72405663|NCT02075840|144319694|SUPERIORITY||Hazard Ratio (HR)|0.5|||<|0.0001|TWO_SIDED|95.0|0.36|0.7|||Log Rank|Stratified hazard ratio and p-value are stratified for covariates Race (Asian vs Non-Asian) and CNS metastases at baseline by IRC.||||0.70|0.36|<0.0001
72405664|NCT02075840|144319696|SUPERIORITY|IRC, RECIST v1.1 Stratified Analysis (by race (Asian vs non-Asian) and CNS metastases at baseline by IRC)|Cause-Specific Hazard Ratio|0.16|||<|0.0001|TWO_SIDED|95.0|0.1|0.28|||Log Rank|||||0.28|0.10|<0.0001
72519618|NCT01068717|144568715|NON_INFERIORITY_OR_EQUIVALENCE|Point estimates and 90% confidence intervals (CIs) were calculated for Treatment B to Treatment A and Treatment D to Treatment C ratios of geometric means for Cmax, AUC(INF), and AUC(0-T) of saxagliptin and metformin, respectively. Potency-corrected results were also provided. Bioequivalence will be concluded if the 90% CIs for the test-to-reference ratios of geometric means are entirely contained within 80% to 125% for both Cmax and AUC(INF). No adjustments were made for multiplicity.|Ratio geometric LS mean|102.77|||||TWO_SIDED|95.0|96.82|109.09||||||To demonstrate the bioequivalence of FDC tablet versus coadministration of saxagliptin and metformin tablets in the fasted and fed states, linear mixed model analyses were performed on log(Cmax), log\[AUC(INF)\], and log\[AUC(0-T)\] of saxagliptin and metformin, respectively. The factors in the model were sequence, period, and treatment as fixed effects and measurements within each subject as repeated measurements allowing for different covariance structures for the fasted and fed states.||109.09|96.82|
72519619|NCT02758119|144568718|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
72519620|NCT00771173|144568731|SUPERIORITY_OR_OTHER|||||||0.745|TWO_SIDED||||||t-test, 2 sided|||The independent samples t-test was used to test the null hypothesis that the mean VAS score for the active treatment cohort (i.e., those receiving pyridium) was no different than the mean VAS score for those receiving placebo.||||.745
72519621|NCT01602549|144568733|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|0.965|||||TWO_SIDED|95.0|0.831|1.12|||||Day 1: The adjusted means (AMs) and ratios were estimated using a mixed model (MM) fitting treatment, visit, treatment\*visit, Baseline L-dopa PK parameter and Baseline gastric emptying half time as fixed effects, and participant as a random effect.|GSK962040 50 mg : Placebo Day 1||1.120|0.831|
72519622|NCT01602549|144568733|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|0.886|||||TWO_SIDED|95.0|0.763|1.029|||||Day 8: The AMs and ratios were estimated using a mixed model fitting treatment, visit, treatment\*visit, Baseline L-dopa PK parameter and Baseline gastric emptying half time as fixed effects, and participant as a random effect.|GSK962040 50 mg : Placebo Day 8||1.029|0.763|
72405665|NCT02075840|144319698|SUPERIORITY||Difference in Overall Response Rates|7.4||||0.0936|TWO_SIDED|95.0|-1.71|16.5||Stratified analysis|Mantel Haenszel|||||16.50|-1.71|0.0936
72542502|NCT00449930|144614782|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-1.9||||0.032||95.0|-3.9|-0.2|||Fisher Exact||"Difference (sitagliptin minus metformin) in the percentage of patients with nausea.~Wilson Score method was used for the 95% CI."|||-0.2|-3.9|0.032
72405666|NCT02075840|144319700|SUPERIORITY||Hazard Ratio (HR)|0.76||||0.2405|TWO_SIDED|95.0|0.48|1.2||Stratified analysis|Log Rank|||||1.20|0.48|0.2405
72542503|NCT00449930|144614783|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-1.7||||0.103||95.0|-4.0|0.3|||Fisher Exact||"Difference (sitagliptin minus metformin) in the percentage of patients with abdominal pain.~Wilson Score method was used for the 95% CI."|||0.3|-4.0|0.103
72405667|NCT02075840|144319711|SUPERIORITY||Hazard Ratio (HR)|0.74||||0.2079|TWO_SIDED|95.0|0.46|1.19|||Log Rank|Stratified analysis||Fatigue||1.19|0.46|0.2079
72405668|NCT02075840|144319711|SUPERIORITY||Hazard Ratio (HR)|1.66||||0.1137|TWO_SIDED|95.0|0.88|3.15||Stratified analysis|Log Rank|||Dyspnea||3.15|0.88|0.1137
72405669|NCT02075840|144319713|SUPERIORITY||Hazard Ratio (HR)|0.88||||0.7042|TWO_SIDED|95.0|0.44|1.74||Stratified analysis|Log Rank|||Coughing||1.74|0.44|0.7042
72405670|NCT02075840|144319713|SUPERIORITY||Hazard Ratio (HR)|1.76||||0.0285|TWO_SIDED|95.0|1.05|2.92||Stratified analysis|Log Rank|||Dyspnea||2.92|1.05|0.0285
72405671|NCT02075840|144319713|SUPERIORITY||Hazard Ratio (HR)|1.43||||0.2377|TWO_SIDED|95.0|0.79|2.61||Stratified analysis|Log Rank|||Pain in arm and shoulder||2.61|0.79|0.2377
72405672|NCT02075840|144319713|SUPERIORITY||Hazard Ratio (HR)|0.51||||0.0796|TWO_SIDED|95.0|0.24|1.1||Stratified analysis|Log Rank|||Pain in chest||1.10|0.24|0.0796
72405673|NCT02075840|144319713|SUPERIORITY||Hazard Ratio (HR)|1.1||||0.6435|TWO_SIDED|95.0|0.72|1.68||Stratified analysis|Log Rank|||Composite score||1.68|0.72|0.6435
72405674|NCT00846742|144319720|SUPERIORITY|||||||0.0003||||||Comparison of proportion of patients' complete response rate between HOD99 (NCT number: NCT00145600) and HOD08|Exact Binominal Test|||The proportion of patients' complete response rate was provided with a 95% confidence interval.||||0.0003
72405675|NCT00846742|144319725|SUPERIORITY||Hazard Ratio (HR)|0.969||||0.732|TWO_SIDED|95.0|0.81|1.159|||Fine-Gray model||The sub-distribution hazard ratio for the 2-year cumulative incidence of local failure with a 1-year increase in age.|||1.159|0.810|0.732
72405676|NCT00846742|144319726|SUPERIORITY||Hazard Ratio (HR)|0.0|||<|0.001|TWO_SIDED|95.0|0.0|0.0|||Fine-Gray model||The sub-distribution hazard ratio for the 2-year cumulative incidence of local failure comparing males to females.|Male vs. Female, with Female as the reference level||0.000|0.000|<0.001
72542504|NCT00449930|144614784|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-1.0||||||95.0|-2.4|0.2|||||"Difference (sitagliptin minus metformin) in the percentage of patients with vomiting.~Wilson Score method was used for the 95% CI."|||0.2|-2.4|
72542505|NCT03550794|144614785|OTHER||Mean Difference (Final Values)|-0.57||||0.07|TWO_SIDED|95.0|-1.18|0.04||"Mixed model controlling for repeated measures within patients used to get a mean difference in creatinine between the thiamine and placebo groups at 72 hours.~Missing creatinine imputed using a penalty (20pc increase) as described in SAP."|Mixed Models Analysis|P-value is for the comparison at 72 hours from the mixed model (i.e, not a global p-value)||||0.04|-1.18|0.07
72542506|NCT03550794|144614786|OTHER||Odds Ratio (OR)|0.58||||0.34|TWO_SIDED|95.0|0.18|1.74||P-value from odds ratio from logistic regression model controlling for site, with outcome of receiving renal replacement therapy.|Regression, Logistic|||||1.74|0.18|0.34
72542507|NCT03550794|144614787|OTHER||Median Difference (Final Values)|22.0||||0.002|TWO_SIDED|95.0|7.4|36.6||P-value from quantile regression model controlling for site.|Quantile regression|||||36.6|7.4|0.002
72519623|NCT01602549|144568733|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|0.937|||||TWO_SIDED|95.0|0.85|1.033|||||Day 8:Day 1: The AMs and ratios were estimated using a mixed model fitting treatment, visit, treatment\*visit, Baseline L-dopa PK parameter and Baseline gastric emptying half time as fixed effects, and participant as a random effect.|Day 8: Day 1||1.033|0.850|
72519624|NCT01602549|144568733|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|1.02|||||TWO_SIDED|95.0|0.89|1.17|||||Day 8:Day 1: The AMs and ratios were estimated using a mixed model fitting treatment, visit, treatment\*visit, Baseline L-dopa PK parameter and Baseline gastric emptying half time as fixed effects, and participant as a random effect.|Day 8:Day 1 Placebo||1.170|0.890|
72405677|NCT00846742|144319727|SUPERIORITY||Hazard Ratio (HR)|30101.41|||<|0.001|TWO_SIDED|95.0|3329.573|272135.5|||Fine-Gray model||The sub-distribution hazard ratio for the 2-year cumulative incidence of local failure comparing Stage IIA to Stage IA.|Stage IIA vs. Stage IA, with Stage IA as the reference level||272135.500|3329.573|<0.001
72405678|NCT00846742|144319728|SUPERIORITY||Hazard Ratio (HR)|34027.68|||<|0.001|TWO_SIDED|95.0|4072.872|284291.6|||Fine-Gray model||The sub-distribution hazard ratio for the 2-year cumulative incidence of local failure comparing Classical (all combined) to Nodular Lymphocyte Predominant Hodgkin Lymphoma.|Classical (all combined) vs. Nodular lymphocyte predominant, with Nodular lymphocyte predominant as the reference level||284291.600|4072.872|<0.001
72519625|NCT01602549|144568735|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|0.864|||||TWO_SIDED|95.0|0.702|1.064|||||Day 1: The AMs and ratios were estimated using a mixed model fitting treatment, visit, treatment\*visit, Baseline L-dopa PK parameter and Baseline gastric emptying half time as fixed effects, and participant as a random effect.|GSK962040 50 mg Vs Placebo Day 1||1.064|0.702|
72519626|NCT01602549|144568735|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|1.018|||||TWO_SIDED|95.0|0.824|1.257|||||Day 8: The AMs and ratios were estimated using a mixed model fitting treatment, visit, treatment\*visit, Baseline L-dopa PK parameter and Baseline gastric emptying half time as fixed effects, and participant as a random effect.|GSK962040 50 mg Vs Placebo Day 8||1.257|0.824|
72569710|NCT02944383|144669990|SUPERIORITY|||||||0.0992||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||EOS (average of week 10 and 12)||||0.0992
72569711|NCT02944383|144669991|SUPERIORITY|||||||0.1512||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.1512
72569712|NCT02944383|144669991|SUPERIORITY|||||||0.84||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.8400
72569713|NCT02944383|144669991|SUPERIORITY|||||||0.0244||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.0244
72569714|NCT02944383|144669991|SUPERIORITY|||||||0.1803||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.1803
72569715|NCT02944383|144669991|SUPERIORITY||Median Difference (Net)|-24.41||||0.0307|TWO_SIDED|95.0|-42.73|-9.94||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|EOS (average of week 10 and 12)||-9.94|-42.73|0.0307
72569716|NCT02944383|144669991|SUPERIORITY||Median Difference (Net)|-8.73||||0.5326|TWO_SIDED|95.0|-23.33|7.68||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|EOS (average of week 10 and 12)||7.68|-23.33|0.5326
72569717|NCT02944383|144669992|SUPERIORITY|||||||0.1705||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.1705
72569718|NCT02944383|144669992|SUPERIORITY|||||||0.9193||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.9193
72569719|NCT02944383|144669992|SUPERIORITY|||||||0.0224||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.0224
72569720|NCT02944383|144669992|SUPERIORITY|||||||0.2387||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.2387
72569721|NCT02944383|144669992|SUPERIORITY|||||||0.06||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||EOS (average of week 10 and 12)||||0.0600
72405679|NCT00846742|144319729|SUPERIORITY|||||||0.461|||||||Log Rank|||Comparing the 2-year EFS between HOD08 Participants and HOD99 Participants||||0.461
72405680|NCT00846742|144319729|SUPERIORITY|||||||1|||||||Log Rank|||Comparing the 2-year OS between HOD08 Participants and HOD99 Participants||||1.000
72405681|NCT00846742|144319729|SUPERIORITY|||||||0.836|||||||Gray's test|||Comparing the 2-year CI of Local Failure between HOD08 Participants and HOD99 Participants||||0.836
72405682|NCT00846742|144319731|SUPERIORITY|||||||0.384|||||||Log Rank|||Comparing the 2-year EFS between HOD08 - CR and HOD99 - CR||||0.384
72519627|NCT01602549|144568735|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|1.018|||||TWO_SIDED|95.0|0.889|1.166|||||Day 8:Day 1: The AMs and ratios were estimated using a mixed model fitting treatment, visit, treatment\*visit, Baseline L-dopa PK parameter and Baseline gastric emptying half time as fixed effects, and participant as a random effect.|Day 8 VS Day 1 GSK962040 50 mg||1.166|0.889|
72519628|NCT01602549|144568735|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|0.865|||||TWO_SIDED|95.0|0.709|1.055|||||Day 8:Day 1: The AMs and ratios were estimated using a mixed model fitting treatment, visit, treatment\*visit, Baseline L-dopa PK parameter and Baseline gastric emptying half time as fixed effects, and participant as a random effect.|Day 8 Vs Day 1 Placebo||1.055|0.709|
72519629|NCT01602549|144568736|SUPERIORITY_OR_OTHER|||||||0.157||95.0|||||Wilcoxon rank-sum test|||Day 1||||0.157
72519630|NCT01602549|144568736|SUPERIORITY_OR_OTHER|||||||0.186||95.0|||||Wilcoxon rank-sum test|||Day 8||||0.186
72519631|NCT01602549|144568738|SUPERIORITY_OR_OTHER||Difference in AMs of change from BL|-4.239|||||TWO_SIDED|95.0|-16.015|7.537|||||Day 1: The AMs and differences (GSK962040 minus Placebo) were estimated using a mixed model fitting treatment, visit, treatment\*visit, and Baseline gastric half emptying time as fixed effects, and participant as a random effect.|GSK962040 50 mg Vs Placebo Day 1||7.537|-16.015|
72519632|NCT01602549|144568738|SUPERIORITY_OR_OTHER||Difference in AMs of change from BL|-5.327|||||TWO_SIDED|95.0|-17.567|6.914|||||Day 8: The AMs and differences (GSK962040 minus Placebo) were estimated using a mixed model fitting treatment, visit, treatment\*visit, and Baseline gastric half emptying time as fixed effects, and participant as a random effect.|GSK962040 50 mg Vs Placebo Day 8||6.914|-17.567|
72519633|NCT01602549|144568739|SUPERIORITY_OR_OTHER||Difference in AMs of change from BL|-2.16||||||95.0|-3.9|-0.41|||||Day 1; Part I: The AMs and differences (GSK 962040 minus Placebo) were estimated using a mixed model fitting treatment, visit, treatment\*visit interaction, and Baseline MDS-UPDR score as fixed effects, and participant as a random effect.|Part I-GSK962040 50 mg Vs Placebo Day 1||-0.41|-3.90|
72519634|NCT01602549|144568739|SUPERIORITY_OR_OTHER||Difference in AMs of change from BL|-3.63|||||TWO_SIDED|95.0|-5.41|-1.85|||||Day 8; Part I: The AMs and differences (GSK 962040 minus Placebo) were estimated using a mixed model fitting treatment, visit, treatment\*visit interaction, and Baseline MDS-UPDR score as fixed effects, and participant as a random effect.|Part I-GSK962040 50 mg Vs Placebo Day 8||-1.85|-5.41|
72519635|NCT01602549|144568739|SUPERIORITY_OR_OTHER||Difference in AMs of change from BL|-2.29|||||TWO_SIDED|95.0|-4.65|0.07|||||Day 1; Part II: The AMs and differences (GSK 962040 minus Placebo) were estimated using a mixed model fitting treatment, visit, treatment\*visit interaction, and Baseline MDS-UPDR score as fixed effects, and participant as a random effect.|Part II- GSK962040 50 mg Vs Placebo Day 1||0.07|-4.65|
72519636|NCT01602549|144568739|SUPERIORITY_OR_OTHER||Difference in AMs of change from BL|-2.46|||||TWO_SIDED|95.0|-4.85|-0.07|||||Day 8; Part II: The AMs and differences (GSK 962040 minus Placebo) were estimated using a mixed model fitting treatment, visit, treatment\*visit interaction, and Baseline MDS-UPDR score as fixed effects, and participant as a random effect.|Part II- GSK962040 50 mg Vs Placebo Day 8||-0.07|-4.85|
72519637|NCT01602549|144568739|SUPERIORITY_OR_OTHER||Difference in AMs of change from BL|-5.38|||||TWO_SIDED|95.0|-10.28|-0.49|||||Day 8; Part III: The AMs and differences (GSK 962040 minus Placebo) were estimated using a mixed model fitting treatment, visit, treatment\*visit interaction, and Baseline MDS-UPDR score as fixed effects, and participant as a random effect.|Part III -GSK962040 50 mg Vs Placebo Day 8||-0.49|-10.28|
72519638|NCT01602549|144568739|SUPERIORITY_OR_OTHER||Difference in AMs of change from BL|-0.56|||||TWO_SIDED|95.0|-1.65|0.54|||||Day 1; Part IV: The AMs and differences (GSK 962040 minus Placebo) were estimated using a mixed model fitting treatment, visit, treatment\*visit interaction, and Baseline MDS-UPDR score as fixed effects, and participant as a random effect.|Part IV-GSK962040 50 mg Vs Placebo Day 1||0.54|-1.65|
72519639|NCT01602549|144568739|SUPERIORITY_OR_OTHER||Difference in AMs of change from BL|-0.9|||||TWO_SIDED|95.0|-2.02|0.22|||||Day 8; Part IV: The AMs and differences (GSK 962040 minus Placebo) were estimated using a mixed model fitting treatment, visit, treatment\*visit interaction, and Baseline MDS-UPDR score as fixed effects, and participant as a random effect.|Part IV-GSK962040 50 mg Vs Placebo Day 8||0.22|-2.02|
72519640|NCT01602549|144568739|SUPERIORITY_OR_OTHER||Difference in AMs of change from BL|-6.69|||||TWO_SIDED|95.0|-13.77|0.39|||||Day 1; Total: The AMs and differences (GSK 962040 minus Placebo) were estimated using a mixed model fitting treatment, visit, treatment\*visit interaction, and Baseline MDS-UPDR score as fixed effects, and participant as a random effect.|Total- GSK962040 50 mg Vs Placebo Day 1||0.39|-13.77|
72519641|NCT01602549|144568739|SUPERIORITY_OR_OTHER||Difference in AMs of change from BL|-12.5|||||TWO_SIDED|95.0|-19.67|-5.29|||||Day 8; Total: The AMs and differences (GSK 962040 minus Placebo) were estimated using a mixed model fitting treatment, visit, treatment\*visit interaction, and Baseline MDS-UPDR score as fixed effects, and participant as a random effect.|Total- GSK962040 50 mg Vs Placebo Day 8||-5.29|-19.67|
72519642|NCT01602549|144568739|SUPERIORITY_OR_OTHER||Difference in AMs of change from BL|-1.7|||||TWO_SIDED|95.0|-6.53|3.13|||||Day 1; Part III: The AMs and differences (GSK 962040 minus Placebo) were estimated using a mixed model fitting treatment, visit, treatment\*visit interaction, and Baseline MDS-UPDR score as fixed effects, and participant as a random effect.|Part III- GSK962040 50 mg Vs Placebo Day 1||3.13|-6.53|
72542508|NCT03550794|144614788|OTHER||Hazard Ratio (HR)|0.62||||0.14|TWO_SIDED|95.0|0.32|1.18||P-value from Cox proportional hazards model adjusting for site.|Regression, Cox|||||1.18|0.32|0.14
72542509|NCT03550794|144614789|OTHER||Odds Ratio (OR)|0.43||||0.07|TWO_SIDED|95.0|0.17|1.06||P-value from logistic regression model controlling for site|Regression, Logistic|||||1.06|0.17|0.07
72542510|NCT03550794|144614790|OTHER||Mean Difference (Final Values)|0.96||||0.79|TWO_SIDED|95.0|0.71|1.3||"Mixed model controlling for repeated measures within patients used to get a mean difference in lactate between the thiamine and placebo groups at 72 hours.~Missing lactate imputed using a penalty (20pc increase) as described in SAP."|Mixed Models Analysis|P-value is for the comparison at 72 hours from the mixed model (i.e, not a global p-value)||||1.30|0.71|0.79
72542511|NCT03550794|144614792|OTHER||Mean Difference (Final Values)|-1.53||||0.16|TWO_SIDED|95.0|-3.63|0.58||"Mixed model controlling for repeated measures within patients used to get a mean difference in SOFA scores between the thiamine and placebo groups at 72 hours.~Missing SOFA imputed using a penalty (20pc increase) as described in SAP."|Mixed Models Analysis|P-value is for the comparison at 72 hours from the mixed model (i.e, not a global p-value)||||0.58|-3.63|0.16
72519643|NCT01602549|144568740|SUPERIORITY_OR_OTHER||Difference in AMs of change from BL|-3.14|||||TWO_SIDED|95.0|-9.07|2.78|||||Day 1; Pre-dose: The AMs and differences (GSK962040 minus Placebo) were estimated using a mixed model fitting treatment, visit, treatment\*visit\*time point interaction, and Baseline UPDRS-3 score as fixed effects, and participant as a random effect.|Pre dose: GSK962040 50 mg Vs Placebo Day 1||2.78|-9.07|
72519644|NCT01602549|144568740|SUPERIORITY_OR_OTHER||Difference in AMs of change from BL|-3.18|||||TWO_SIDED|95.0|-9.11|2.75|||||Day 1; 120 min PD: The AMs and differences (GSK962040 minus Placebo) were estimated using a mixed model fitting treatment, visit, treatment\*visit\*time point interaction, and Baseline UPDRS-3 score as fixed effects, and participant as a random effect.|120 min PD: GSK962040 50 mg Vs Placebo Day 1||2.75|-9.11|
72519645|NCT01602549|144568740|SUPERIORITY_OR_OTHER||Difference in AMs of change from BL|-3.66|||||TWO_SIDED|95.0|-9.59|2.27|||||Day 1; 180 min PD: The AMs and differences (GSK962040 minus Placebo) were estimated using a mixed model fitting treatment, visit, treatment\*visit\*time point interaction, and Baseline UPDRS-3 score as fixed effects, and participant as a random effect.|180 min PD: GSK962040 50 mg Vs Placebo Day 1:||2.27|-9.59|
72519646|NCT01602549|144568740|SUPERIORITY_OR_OTHER||Difference in AMs of change from BL|-4.15|||||TWO_SIDED|95.0|-10.07|1.76|||||Day 1; 240 min PD: The AMs and differences (GSK962040 minus Placebo) were estimated using a mixed model fitting treatment, visit, treatment\*visit\*time point interaction, and Baseline UPDRS-3 score as fixed effects, and participant as a random effect.|240 min PD: GSK962040 50 mg Vs Placebo Day 1||1.76|-10.07|
72519647|NCT01602549|144568740|SUPERIORITY_OR_OTHER||Difference in AMs of change from BL|-6.8|||||TWO_SIDED|95.0|-12.79|-0.81|||||Day 8; Pre-dose: The AMs and differences (GSK962040 minus Placebo) were estimated using a mixed model fitting treatment, visit, treatment\*visit\*time point interaction, and Baseline UPDRS-3 score as fixed effects, and participant as a random effect.|Pre dose: GSK962040 50 mg Vs Placebo Day 8||-0.81|-12.79|
72519648|NCT01602549|144568740|SUPERIORITY_OR_OTHER||Difference in AMs of change from BL|-3.97|||||TWO_SIDED|95.0|-9.96|2.03|||||Day 8; 120 min PD: The AMs and differences (GSK962040 minus Placebo) were estimated using a mixed model fitting treatment, visit, treatment\*visit\*time point interaction, and Baseline UPDRS-3 score as fixed effects, and participant as a random effect.|120 min PD: GSK962040 50 mg Vs Placebo Day 8||2.03|-9.96|
72519649|NCT01602549|144568740|SUPERIORITY_OR_OTHER||Difference in AMs of change from BL|-5.29|||||TWO_SIDED|95.0|-11.29|0.71|||||Day 8; 180 min PD: The AMs and differences (GSK962040 minus Placebo) were estimated using a mixed model fitting treatment, visit, treatment\*visit\*time point interaction, and Baseline UPDRS-3 score as fixed effects, and participant as a random effect.|180 min PD: GSK962040 50 mg Vs Placebo Day 8||0.71|-11.29|
72519650|NCT01602549|144568740|SUPERIORITY_OR_OTHER||Difference in AMs of change from BL|-8.9|||||TWO_SIDED|95.0|-14.88|-2.91|||||Day 8; 240 min PD: The AMs and differences (GSK962040 minus Placebo) were estimated using a mixed model fitting treatment, visit, treatment\*visit\*time point interaction, and Baseline UPDRS-3 score as fixed effects, and participant as a random effect.|240 min PD: GSK962040 50 mg Vs Placebo Day 8||-2.91|-14.88|
72405683|NCT00846742|144319731|SUPERIORITY|||||||1|||||||Log Rank|||Comparing the 2-year OS between HOD08 - CR and HOD99 - CR||||1.000
72519651|NCT01602549|144568741|SUPERIORITY_OR_OTHER||Difference in AMs of change from BL|-2.31|||||TWO_SIDED|95.0|-3.71|-0.9|||||OFF: Treatment Period: The AMs and differences (GSK962040 minus Placebo) were estimated using an analysis of covariance (ANCOVA) model fitting treatment and Baseline amount of hours spent ON/OFF as main effects.|OFF: Treatment Period||-0.90|-3.71|
72519652|NCT01602549|144568741|SUPERIORITY_OR_OTHER||Difference in AMs of change from BL|1.88|||||TWO_SIDED|95.0|0.28|3.48|||||ON: Treatment Period: The AMs and differences (GSK962040 minus Placebo) were estimated using an analysis of covariance (ANCOVA) model fitting treatment and Baseline amount of hours spent ON/OFF as main effects.|ON: Treatment Period||3.48|0.28|
72519653|NCT01602549|144568742|SUPERIORITY_OR_OTHER||Difference in AMs of change from BL|-2.83|||||TWO_SIDED|95.0|-21.79|16.13|||||Day 1, pre-dose: The AMs/differences (GSK962040 minus Placebo) were estimated using a MM fitting treatment, visit, time point (TP), treatment\*visit\*TP interaction, and BL score as fixed effects, TP as a repeated effect, and par. as a random effect.|Pre-dose: Day GSK962040 50 mg Vs Placebo Day 1||16.13|-21.79|
72519654|NCT01602549|144568742|SUPERIORITY_OR_OTHER||Difference in AMs of change from BL|0.58|||||TWO_SIDED|95.0|-18.39|19.56|||||Day 1, 0 min PD: The AMs/differences (GSK962040 minus Placebo) were estimated using a MM fitting treatment, visit, time point (TP), treatment\*visit\*TP interaction, and BL score as fixed effects, TP as a repeated effect, and par. as a random effect.|0 min PD: GSK962040 50 mg Vs Placebo Day 1||19.56|-18.39|
72519655|NCT01602549|144568742|SUPERIORITY_OR_OTHER||Difference in AMs of change from BL|1.84|||||TWO_SIDED|95.0|-17.18|20.86|||||Day 1, 30 min PD: The AMs/differences (GSK962040 minus Placebo) were estimated using a MM fitting treatment, visit, time point (TP), treatment\*visit\*TP interaction, and BL score as fixed effects, TP as a repeated effect, and par. as a random effect.|Day 1, 30 min PD||20.86|-17.18|
72519656|NCT01602549|144568742|SUPERIORITY_OR_OTHER||Difference in AMs of change from BL|0.28|||||TWO_SIDED|95.0|-18.72|19.28|||||Day 1, 60 min PD: The AMs/differences (GSK962040 minus Placebo) were estimated using a MM fitting treatment, visit, time point (TP), treatment\*visit\*TP interaction, and BL score as fixed effects, TP as a repeated effect, and par. as a random effect.|60 min PD: GSK962040 50 mg Vs Placebo Day 1||19.28|-18.72|
72519657|NCT01602549|144568742|SUPERIORITY_OR_OTHER||Difference in AMs of change from BL|-3.38|||||TWO_SIDED|95.0|-22.35|15.58|||||Day 1, 90 min PD: The AMs/differences (GSK962040 minus Placebo) were estimated using a MM fitting treatment, visit, time point (TP), treatment\*visit\*TP interaction, and BL score as fixed effects, TP as a repeated effect, and par. as a random effect.|90 min PD: GSK962040 50 mg Vs Placebo Day 1||15.58|-22.35|
72569722|NCT02944383|144669992|SUPERIORITY|||||||0.6878||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||EOS (average of week 10 and 12)||||0.6878
72405684|NCT00846742|144319731|SUPERIORITY|||||||0.386|||||||Gray's test|||Comparing the 2-year CI of Local Failure between HOD08 - CR and HOD99 - CR||||0.386
72405685|NCT00846742|144319732|SUPERIORITY|||||||0.986|||||||Log Rank|||Comparing the 2-year EFS of patients treated without and with RT||||0.986
72405686|NCT03909165|144319743|OTHER||Geometric Mean Ratio (GMR)|0.83|||||TWO_SIDED|90.0|0.56|1.21||||||2 mg/kg AUC0-inf Geometric Mean Ratio (GMR) = Birth to 27 days AUC0-inf Geometric Mean (GM) / 28 days to \< 3 months AUC0-inf GM.||1.21|0.56|
72519658|NCT01602549|144568742|SUPERIORITY_OR_OTHER||Difference in AMs of change from BL|-4.18|||||TWO_SIDED|95.0|-23.13|14.76|||||Day 1, 120 min PD: The AMs/differences (GSK962040 minus Placebo) were estimated using a MM fitting treatment, visit, time point (TP), treatment\*visit\*TP interaction, and BL score as fixed effects, TP as a repeated effect, and par. as a random effect.|120 min PD: GSK962040 50 mg Vs Placebo Day 1||14.76|-23.13|
72519659|NCT01602549|144568742|SUPERIORITY_OR_OTHER||Difference in AMs of change from BL|-6.39|||||TWO_SIDED|95.0|-25.36|12.58|||||Day 1, 180 min PD: The AMs/differences (GSK962040 minus Placebo) were estimated using a MM fitting treatment, visit, time point (TP), treatment\*visit\*TP interaction, and BL score as fixed effects, TP as a repeated effect, and par. as a random effect.|180 min PD: GSK962040 50 mg Vs Placebo Day 1||12.58|-25.36|
72519660|NCT01602549|144568742|SUPERIORITY_OR_OTHER||Difference in AMs of change from BL|0.77|||||TWO_SIDED|95.0|-18.2|19.75|||||Day 1, 240 min PD: The AMs/differences (GSK962040 minus Placebo) were estimated using a MM fitting treatment, visit, time point (TP), treatment\*visit\*TP interaction, and BL score as fixed effects, TP as a repeated effect, and par. as a random effect.|240 min PD: GSK962040 50 mg Vs Placebo Day 1||19.75|-18.20|
72519661|NCT01602549|144568742|SUPERIORITY_OR_OTHER||Difference in AMs of change from BL|0.51|||||TWO_SIDED|95.0|-18.51|19.52|||||Day 8, pre-dose: The AMs/differences (GSK962040 minus Placebo) were estimated using a MM fitting treatment, visit, time point (TP), treatment\*visit\*TP interaction, and BL score as fixed effects, TP as a repeated effect, and par. as a random effect.|Pre-dose: GSK962040 50 mg Vs Placebo Day 8||19.52|-18.51|
72519662|NCT01602549|144568742|SUPERIORITY_OR_OTHER||Difference in AMs of change from BL|3.32|||||TWO_SIDED|95.0|-15.7|22.33|||||Day 8, 0 min PD: The AMs/differences (GSK962040 minus Placebo) were estimated using a MM fitting treatment, visit, time point (TP), treatment\*visit\*TP interaction, and BL score as fixed effects, TP as a repeated effect, and par. as a random effect.|0 min PD: GSK962040 50 mg Vs Placebo Day 8||22.33|-15.70|
72519663|NCT01602549|144568742|SUPERIORITY_OR_OTHER||Difference in AMs of change from BL|-2.94|||||TWO_SIDED|95.0|-21.97|16.08|||||Day 8, 30 min PD: The AMs/differences (GSK962040 minus Placebo) were estimated using a MM fitting treatment, visit, time point (TP), treatment\*visit\*TP interaction, and BL score as fixed effects, TP as a repeated effect, and par. as a random effect.|30 min PD: GSK962040 50 mg Vs Placebo Day 8||16.08|-21.97|
72519664|NCT01602549|144568742|SUPERIORITY_OR_OTHER||Difference in AMs of change from BL|-3.12|||||TWO_SIDED|95.0|-22.13|15.88|||||Day 8, 60 min PD: The AMs/differences (GSK962040 minus Placebo) were estimated using a MM fitting treatment, visit, time point (TP), treatment\*visit\*TP interaction, and BL score as fixed effects, TP as a repeated effect, and par. as a random effect.|60 min PD: GSK962040 50 mg Vs Placebo Day 8||15.88|-22.13|
72569723|NCT02944383|144669993|SUPERIORITY|||||||0.0298||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.0298
72569724|NCT02944383|144669993|SUPERIORITY|||||||0.0196||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.0196
72569725|NCT02944383|144669993|SUPERIORITY|||||||0.2219||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.2219
72569726|NCT02944383|144669993|SUPERIORITY|||||||0.4078||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.4078
72519665|NCT01602549|144568742|SUPERIORITY_OR_OTHER||Difference in AMs of change from BL|-1.38|||||TWO_SIDED|95.0|-20.4|17.63|||||Day 8, 90 min PD: The AMs/differences (GSK962040 minus Placebo) were estimated using a MM fitting treatment, visit, time point (TP), treatment\*visit\*TP interaction, and BL score as fixed effects, TP as a repeated effect, and par. as a random effect.|90 min PD: GSK962040 50 mg Vs Placebo Day 8||17.63|-20.40|
72519666|NCT01602549|144568742|SUPERIORITY_OR_OTHER||Difference in AMs of change from BL|-0.71|||||TWO_SIDED|95.0|-19.7|18.28|||||Day 8, 120 min PD: The AMs/differences (GSK962040 minus Placebo) were estimated using a MM fitting treatment, visit, time point (TP), treatment\*visit\*TP interaction, and BL score as fixed effects, TP as a repeated effect, and par. as a random effect.|120 min PD: GSK962040 50 mg Vs Placebo Day 8||18.28|-19.70|
72519667|NCT01602549|144568742|SUPERIORITY_OR_OTHER||Difference in AMs of change from BL|3.02|||||TWO_SIDED|95.0|-15.98|22.02|||||Day 8, 180 min PD: The AMs/differences (GSK962040 minus Placebo) were estimated using a MM fitting treatment, visit, time point (TP), treatment\*visit\*TP interaction, and BL score as fixed effects, TP as a repeated effect, and par. as a random effect.|180 min PD: GSK962040 50 mg Vs Placebo Day 8||22.02|-15.98|
72519668|NCT01602549|144568742|SUPERIORITY_OR_OTHER||Difference in AMs of change from BL|4.08|||||TWO_SIDED|95.0|-14.91|23.07|||||Day 8, 240 min PD: The AMs/differences (GSK962040 minus Placebo) were estimated using a MM fitting treatment, visit, time point (TP), treatment\*visit\*TP interaction, and BL score as fixed effects, TP as a repeated effect, and par. as a random effect.|240 min PD: GSK962040 50 mg Vs Placebo Day 8||23.07|-14.91|
72519669|NCT00719862|144568762|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.05|STANDARD_DEVIATION|0.3782||0.005||95.0|-1.8|-0.31|||ANOVA|ANCOVA is being used due to a covariate being included in the model. The covariate is baseline TNSS score.||||-0.31|-1.80|0.005
72519670|NCT00719862|144568763|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.2987|STANDARD_DEVIATION|0.1881||0.112||95.0|-0.67|0.07|||ANOVA|ANCOVA is being used due to a covariate being included in the model. The covariate is baseline TNSS score.||||0.07|-0.67|0.112
72519671|NCT00719862|144568764|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8617|STANDARD_DEVIATION|0.3803||0.023||95.0|-1.61|-0.12|||ANCOVA|ANCOVA is being used due to a covariate being included in the model. The covariate is baseline TNSS score.||||-0.12|-1.61|0.023
72519672|NCT00719862|144568765|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7395|STANDARD_DEVIATION|0.3305||0.025||95.0|-1.39|-0.09|||ANOVA|ANCOVA is being used due to a covariate being included in the model. The covariate is baseline TNSS score.||Change in baseline||-0.09|-1.39|0.025
72519673|NCT00719862|144568766|SUPERIORITY_OR_OTHER|||||||0.051|||||||ANOVA|||Change from baseline||||0.051
72519674|NCT00892957|144568769|SUPERIORITY_OR_OTHER||||||<|0.0001|ONE_SIDED|95.0|||||Likelihood ratio chi-square test|||||||<0.0001
72519675|NCT00892957|144568770|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED|95.0|||||Likelihood ratio chi-square test|||||||0.001
72519676|NCT00892957|144568771|SUPERIORITY_OR_OTHER|||||||0.012|TWO_SIDED|95.0|||||Likelihood ratio chi-square test|||||||0.012
72519677|NCT00892957|144568772|SUPERIORITY_OR_OTHER|||||||0.158|TWO_SIDED|95.0|||||Likelihood ratio chi-square test|||||||0.158
72519678|NCT00892957|144568774|SUPERIORITY_OR_OTHER|||||||0.38|TWO_SIDED|95.0|||||Likelihood ratio chi-square test|||||||0.380
72405687|NCT03909165|144319743|OTHER||Geometric Mean Ratio (GMR)|1.41|||||TWO_SIDED|90.0|1.0|1.98||||||2 mg/kg AUC0-inf GMR = 28 days to \< 3 months AUC0-inf GM / 3 to \< 6 months AUC0-inf GM.||1.98|1.00|
72519679|NCT00892957|144568775|SUPERIORITY_OR_OTHER|||||||0.545|TWO_SIDED|95.0|||||Likelihood ratio chi-square test|||||||0.545
72569727|NCT02944383|144669993|SUPERIORITY||Median Difference (Net)|-15.34||||0.0605|TWO_SIDED|95.0|-31.68|1.3||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|EOS (average of week 10 and 12)||1.30|-31.68|0.0605
72569728|NCT02944383|144669993|SUPERIORITY||Median Difference (Net)|-4.08||||0.1768|TWO_SIDED|95.0|-19.91|7.32||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|EOS (average of week 10 and 12)||7.32|-19.91|0.1768
72405688|NCT03909165|144319743|OTHER||Geometric Mean Ratio (GMR)|0.82|||||TWO_SIDED|90.0|0.6|1.11||||||2 mg/kg AUC0-inf GMR = 3 to \< 6 months AUC0-inf GM / 6 months to \< 2 years AUC0-inf GM.||1.11|0.60|
72405689|NCT03909165|144319743|OTHER||Geometric Mean Ratio (GMR)|1.23|||||TWO_SIDED|90.0|0.96|1.56||||||4 mg/kg AUC0-inf GMR = Birth to 27 days AUC0-inf GM / 28 days to \< 3 months AUC0-inf GM.||1.56|0.96|
72519680|NCT02483078|144568836|SUPERIORITY|||||||0.0032|||||||Fisher Exact|The Fisher's Exact test if the count in any cell was less than 5; otherwise Chi-Square test was to be used||||||.0032
72519681|NCT02483078|144568837|SUPERIORITY|||||||0.0377|||||||Fisher Exact|||||||.0377
72519682|NCT02483078|144568838|SUPERIORITY|||||||0.1201|||||||Fisher Exact|||||||.1201
72519683|NCT02483078|144568839|SUPERIORITY|||||||0.0013|||||||ANCOVA|||||||.0013
72519684|NCT02483078|144568843|SUPERIORITY|||||||0.7123|||||||ANCOVA|||The raw and change from baseline in CD4 cell count at the end of the 1-week double blind treatment period was to be summarized by treatment group for the first week during the double-blind treatment phase. For change from baseline summaries, subjects with an undefined change from baseline, because of missing data, were to be excluded.||||.7123
72519685|NCT02483078|144568845|SUPERIORITY|||||||0.0993|||||||Fisher Exact|||||||.0993
72519686|NCT04532918|144568919|OTHER|Analysis of variance of log transformed PK parameter with treatment and participant as fixed effects|Geometric Mean Ratio (%)|255.3|||||TWO_SIDED|90.0|208.7|312.3|||||Pairwise comparisons of Test 1/ reference (verinurad+allopurinol+cyclosporine/ verinurad+allopurinol alone)|Statistical comparison of Cmax||312.3|208.7|
72519687|NCT04532918|144568919|OTHER|Analysis of variance of log transformed PK parameter with treatment and participant as fixed effects|Geometric Mean Ratio (%)|189.5|||||TWO_SIDED|90.0|154.0|233.1|||||Pairwise comparisons of Test 2/ reference (verinurad+allopurinol+rifampicin/ verinurad+allopurinol alone)|Statistical comparison of Cmax||233.1|154.0|
72519688|NCT04532918|144568920|OTHER|Analysis of variance of log transformed PK parameter with treatment and participant as fixed effects|Geometric Mean Ratio (%)|238.4|||||TWO_SIDED|90.0|207.6|273.8|||||Pairwise comparisons of Test 1/ reference (verinurad+allopurinol+cyclosporine/ verinurad+allopurinol alone)|Statistical comparison of AUCinf||273.8|207.6|
72519689|NCT04532918|144568920|OTHER|Analysis of variance of log transformed PK parameter with treatment and participant as fixed effects|Geometric Mean Ratio (%)|148.9|||||TWO_SIDED|90.0|129.1|171.7|||||Pairwise comparisons of Test 2/ reference (verinurad+allopurinol+rifampicin/ verinurad+allopurinol alone)|Statistical comparison of AUCinf||171.7|129.1|
72519690|NCT04532918|144568921|OTHER|Analysis of variance of log transformed PK parameter with treatment and participant as fixed effects|Geometric Mean Ratio (%)|261.8|||||TWO_SIDED|90.0|229.8|298.1|||||Pairwise comparisons of Test 1/ reference (verinurad+allopurinol+cyclosporine/ verinurad+allopurinol alone)|Statistical comparison of AUClast||298.1|229.8|
72519691|NCT04532918|144568921|OTHER|Analysis of variance of log transformed PK parameter with treatment and participant as fixed effects|Geometric Mean Ratio (%)|163.2|||||TWO_SIDED|90.0|142.8|186.6|||||Pairwise comparisons of Test 2/ reference (verinurad+allopurinol+rifampicin/ verinurad+allopurinol alone)|Statistical comparison of AUClast||186.6|142.8|
72519692|NCT04532918|144568922|OTHER|Analysis of variance of log transformed PK parameter with treatment and participant as fixed effects|Geometric Mean Ratio (%)|273.4|||||TWO_SIDED|90.0|227.9|328.1|||||Pairwise comparisons of Test 1/ reference (verinurad+allopurinol+cyclosporine/ verinurad+allopurinol alone)|Statistical comparison of Cmax for metabolite: M1||328.1|227.9|
72519693|NCT04532918|144568922|OTHER|Analysis of variance of log transformed PK parameter with treatment and participant as fixed effects|Geometric Mean Ratio (%)|275.9|||||TWO_SIDED|90.0|228.7|332.7|||||Pairwise comparisons of Test 2/ reference (verinurad+allopurinol+rifampicin/ verinurad+allopurinol alone)|Statistical comparison of Cmax for metabolite: M1||332.7|228.7|
72519694|NCT04532918|144568922|OTHER|Analysis of variance of log transformed PK parameter with treatment and participant as fixed effects|Geometric Mean Ratio (%)|24.65|||||TWO_SIDED|90.0|19.15|31.72|||||Pairwise comparisons of Test 1/ reference (verinurad+allopurinol+cyclosporine/ verinurad+allopurinol alone)|Statistical comparison of Cmax for metabolite: M8||31.72|19.15|
72519695|NCT04532918|144568922|OTHER|Analysis of variance of log transformed PK parameter with treatment and participant as fixed effects|Geometric Mean Ratio (%)|37.82|||||TWO_SIDED|90.0|29.18|49.03|||||Pairwise comparisons of Test 2/ reference (verinurad+allopurinol+rifampicin/ verinurad+allopurinol alone)|Statistical comparison of Cmax for metabolite: M8||49.03|29.18|
72519696|NCT04532918|144568923|OTHER|Analysis of variance of log transformed PK parameter with treatment and participant as fixed effects|Geometric Mean Ratio (%)|291.8|||||TWO_SIDED|90.0|260.6|326.8|||||Pairwise comparisons of Test 1/ reference (verinurad+allopurinol+cyclosporine/ verinurad+allopurinol alone)|Statistical comparison of AUCinf for metabolite: M1||326.8|260.6|
72519697|NCT04532918|144568923|OTHER|Analysis of variance of log transformed PK parameter with treatment and participant as fixed effects|Geometric Mean Ratio (%)|215.8|||||TWO_SIDED|90.0|192.0|242.4|||||Pairwise comparisons of Test 2/ reference (verinurad+allopurinol+rifampicin/ verinurad+allopurinol alone)|Statistical comparison of Cmax for metabolite: M1||242.4|192.0|
72519698|NCT04532918|144568923|OTHER|Analysis of variance of log transformed PK parameter with treatment and participant as fixed effects|Geometric Mean Ratio (%)|55.31|||||TWO_SIDED|90.0|47.19|64.83|||||Pairwise comparisons of Test 1/ reference (verinurad+allopurinol+cyclosporine/ verinurad+allopurinol alone)|Statistical comparison of AUCinf for metabolite: M8||64.83|47.19|
72519699|NCT04532918|144568923|OTHER|Analysis of variance of log transformed PK parameter with treatment and participant as fixed effects|Geometric Mean Ratio (%)|68.28|||||TWO_SIDED|90.0|57.99|80.39|||||Pairwise comparisons of Test 2/ reference (verinurad+allopurinol+rifampicin/ verinurad+allopurinol alone)|Statistical comparison of AUCinf for metabolite: M8||80.39|57.99|
72519700|NCT04532918|144568924|OTHER|Analysis of variance of log transformed PK parameter with treatment and participant as fixed effects|Geometric Mean Ratio (%)|306.4|||||TWO_SIDED|90.0|273.3|343.6|||||Pairwise comparisons of Test 1/ reference (verinurad+allopurinol+cyclosporine/ verinurad+allopurinol alone)|Statistical comparison of AUClast for metabolite: M1||343.6|273.3|
72519701|NCT04532918|144568924|OTHER|Analysis of variance of log transformed PK parameter with treatment and participant as fixed effects|Geometric Mean Ratio (%)|227.4|||||TWO_SIDED|90.0|202.1|255.8|||||Pairwise comparisons of Test 2/ reference (verinurad+allopurinol+rifampicin/ verinurad+allopurinol alone)|Statistical comparison of AUClast for metabolite: M1||255.8|202.1|
72519702|NCT04532918|144568924|OTHER|Analysis of variance of log transformed PK parameter with treatment and participant as fixed effects|Geometric Mean Ratio (%)|51.03|||||TWO_SIDED|90.0|43.8|59.45|||||Pairwise comparisons of Test 1/ reference (verinurad+allopurinol+cyclosporine/ verinurad+allopurinol alone)|Statistical comparison of AUClast for metabolite: M8||59.45|43.80|
72569729|NCT02944383|144669994|SUPERIORITY|||||||0.0084||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.0084
72569730|NCT02944383|144669994|SUPERIORITY|||||||0.0047||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.0047
72569731|NCT02944383|144669994|SUPERIORITY|||||||0.1574||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.1574
72569732|NCT02944383|144669994|SUPERIORITY|||||||0.3235||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.3235
72569733|NCT02944383|144669994|SUPERIORITY|||||||0.0367||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||EOS (average of week 10 and 12)||||0.0367
72569734|NCT02944383|144669994|SUPERIORITY|||||||0.0948||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||EOS (average of week 10 and 12)||||0.0948
72569735|NCT02944383|144669995|SUPERIORITY|||||||0.0037||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.0037
72569736|NCT02944383|144669995|SUPERIORITY|||||||0.1328||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.1328
72569737|NCT02944383|144669995|SUPERIORITY|||||||0.4364||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.4364
72519703|NCT04532918|144568924|OTHER|Analysis of variance of log transformed PK parameter with treatment and participant as fixed effects|Geometric Mean Ratio (%)|70.45|||||TWO_SIDED|90.0|60.21|82.44|||||Pairwise comparisons of Test 2/ reference (verinurad+allopurinol+rifampicin/ verinurad+allopurinol alone)|Statistical comparison of AUClast for metabolite: M8||82.44|60.21|
72519704|NCT04532918|144568925|OTHER|Analysis of variance of log transformed PK parameter with treatment and participant as fixed effects|Geometric Mean Ratio (%)|74.84|||||TWO_SIDED|90.0|59.42|94.26|||||Pairwise comparisons of Test 1/ reference (verinurad+allopurinol+cyclosporine/ verinurad+allopurinol alone)|Statistical comparison of Cmax for allopurinol||94.26|59.42|
72519705|NCT04532918|144568925|OTHER|Analysis of variance of log transformed PK parameter with treatment and participant as fixed effects|Geometric Mean Ratio (%)|80.99|||||TWO_SIDED|90.0|63.88|102.7|||||Pairwise comparisons of Test 2/ reference (verinurad+allopurinol+rifampicin/ verinurad+allopurinol alone)|Statistical comparison of Cmax for allopurinol||102.7|63.88|
72519706|NCT04532918|144568925|OTHER|Analysis of variance of log transformed PK parameter with treatment and participant as fixed effects|Geometric Mean Ratio (%)|96.86|||||TWO_SIDED|90.0|92.11|101.8|||||Pairwise comparisons of Test 1/ reference (verinurad+allopurinol+cyclosporine/ verinurad+allopurinol alone)|Statistical comparison of Cmax for oxypurinol||101.8|92.11|
72519707|NCT04532918|144568925|OTHER|Analysis of variance of log transformed PK parameter with treatment and participant as fixed effects|Geometric Mean Ratio (%)|99.07|||||TWO_SIDED|90.0|94.36|104.0|||||Pairwise comparisons of Test 2/ reference (verinurad+allopurinol+rifampicin/ verinurad+allopurinol alone)|Statistical comparison of Cmax for oxypurinol||104.0|94.36|
72519708|NCT04532918|144568926|OTHER|Analysis of variance of log transformed PK parameter with treatment and participant as fixed effects|Geometric Mean Ratio (%)|98.29|||||TWO_SIDED|90.0|91.26|105.9|||||Pairwise comparisons of Test 1/ reference (verinurad+allopurinol+cyclosporine/ verinurad+allopurinol alone)|Statistical comparison of AUCinf for allopurinol||105.9|91.26|
72569738|NCT02944383|144669995|SUPERIORITY|||||||0.8129||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.8129
72569739|NCT02944383|144669995|SUPERIORITY||Median Difference (Net)|-15.29||||0.0347|TWO_SIDED|95.0|-36.54|2.35||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|EOS (average of week 10 and 12)||2.35|-36.54|0.0347
72569740|NCT02944383|144669995|SUPERIORITY||Median Difference (Net)|-2.14||||0.3617|TWO_SIDED|95.0|-25.78|23.62||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|EOS (average of week 10 and 12)||23.62|-25.78|0.3617
72569741|NCT02944383|144669996|SUPERIORITY|||||||0.0085||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.0085
72624952|NCT02757768|144779451|SUPERIORITY||LS Mean of Difference|-1.75|STANDARD_ERROR_OF_MEAN|1.3||0.179|TWO_SIDED|95.0|-4.29|0.8|||ANCOVA|||Week 4 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||0.80|-4.29|0.179
72405690|NCT03909165|144319743|OTHER||Geometric Mean Ratio (GMR)|1.29|||||TWO_SIDED|90.0|1.03|1.62||||||4 mg/kg AUC0-inf GMR = 28 days to \< 3 months AUC0-inf GM / 3 to \< 6 months AUC0-inf GM.||1.62|1.03|
72519709|NCT04532918|144568926|OTHER|Analysis of variance of log transformed PK parameter with treatment and participant as fixed effects|Geometric Mean Ratio (%)|101.2|||||TWO_SIDED|90.0|93.72|109.2|||||Pairwise comparisons of Test 2/ reference (verinurad+allopurinol+rifampicin/ verinurad+allopurinol alone)|Statistical comparison of AUCinf for allopurinol||109.2|93.72|
72519710|NCT04532918|144568926|OTHER|Analysis of variance of log transformed PK parameter with treatment and participant as fixed effects|Geometric Mean Ratio (%)|99.16|||||TWO_SIDED|90.0|95.02|103.5|||||Pairwise comparisons of Test 1/ reference (verinurad+allopurinol+cyclosporine/ verinurad+allopurinol alone)|Statistical comparison of AUCinf for oxypurinol||103.5|95.02|
72519711|NCT04532918|144568926|OTHER|Analysis of variance of log transformed PK parameter with treatment and participant as fixed effects|Geometric Mean Ratio (%)|96.05|||||TWO_SIDED|90.0|92.15|100.1|||||Pairwise comparisons of Test 2/ reference (verinurad+allopurinol+rifampicin/ verinurad+allopurinol alone)|Statistical comparison of AUCinf for oxypurinol||100.1|92.15|
72624953|NCT02757768|144779451|SUPERIORITY||LS Mean of Difference|-3.84|STANDARD_ERROR_OF_MEAN|1.41||0.006|TWO_SIDED|95.0|-6.6|-1.08|||ANCOVA|||Week 8 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||-1.08|-6.60|0.006
72519712|NCT04532918|144568927|OTHER|Analysis of variance of log transformed PK parameter with treatment and participant as fixed effects|Geometric Mean Ratio (%)|98.25|||||TWO_SIDED|90.0|91.1|106.0|||||Pairwise comparisons of Test 1/ reference (verinurad+allopurinol+cyclosporine/ verinurad+allopurinol alone)|Statistical comparison of AUClast for allopurinol||106.0|91.10|
72519713|NCT04532918|144568927|OTHER|Analysis of variance of log transformed PK parameter with treatment and participant as fixed effects|Geometric Mean Ratio (%)|101.6|||||TWO_SIDED|90.0|93.99|109.8|||||Pairwise comparisons of Test 2/ reference (verinurad+allopurinol+rifampicin/ verinurad+allopurinol alone)|Statistical comparison of AUClast for allopurinol||109.8|93.99|
72519714|NCT04532918|144568927|OTHER|Analysis of variance of log transformed PK parameter with treatment and participant as fixed effects|Geometric Mean Ratio (%)|98.05|||||TWO_SIDED|90.0|94.5|101.7|||||Pairwise comparisons of Test 1/ reference (verinurad+allopurinol+cyclosporine/ verinurad+allopurinol alone)|Statistical comparison of AUClast for oxypurinol||101.7|94.50|
72519715|NCT04532918|144568927|OTHER||Geometric Mean Ratio (%)|95.98|||||TWO_SIDED|90.0|92.61|99.48|||||Pairwise comparisons of Test 2/ reference (verinurad+allopurinol+rifampicin/ verinurad+allopurinol alone)|Analysis of variance of log transformed PK parameter with treatment and participant as fixed effects||99.48|92.61|
72519716|NCT02564029|144568946|OTHER||Mean Difference (Final Values)|-6.23|STANDARD_ERROR_OF_MEAN|1.37|||TWO_SIDED|90.0|-8.6|-3.86|||Mixed Model Repeated Measures Analysis|||A mixed effects model was applied with fixed effects for period, time, treatment, and the interaction between treatment and time. Baseline was included as 2 separate covariates. The interaction between each baseline covariate and time were included as fixed effects. Participant was fitted as a random effect and time was fitted as a repeated effect within each participant × period. An unstructured correlation matrix was used. The effect reported is an average across all post-dose measurements.||-3.86|-8.60|
72519717|NCT02564029|144568946|OTHER||Mean Difference (Final Values)|-5.42|STANDARD_ERROR_OF_MEAN|1.36|||TWO_SIDED|90.0|-7.78|-3.06|||Mixed Model Repeated Measures Analysis|||A mixed effects model was applied with fixed effects for period, time, treatment, and the interaction between treatment and time. Baseline was included as 2 separate covariates. The interaction between each baseline covariate and time were included as fixed effects. Participant was fitted as a random effect and time was fitted as a repeated effect within each participant × period. An unstructured correlation matrix was used. The effect reported is an average across all post-dose measurements.||-3.06|-7.78|
72519718|NCT02564029|144568946|OTHER||Mean Difference (Final Values)|-5.22|STANDARD_ERROR_OF_MEAN|1.37|||TWO_SIDED|90.0|-7.6|-2.84|||Mixed Model Repeated Measures Analysis|||A mixed effects model was applied with fixed effects for period, time, treatment, and the interaction between treatment and time. Baseline was included as 2 separate covariates. The interaction between each baseline covariate and time were included as fixed effects. Participant was fitted as a random effect and time was fitted as a repeated effect within each participant × period. An unstructured correlation matrix was used. The effect reported is an average across all post-dose measurements.||-2.84|-7.60|
72519719|NCT02564029|144568946|OTHER||Mean Difference (Final Values)|0.81|STANDARD_ERROR_OF_MEAN|1.38|||TWO_SIDED|90.0|-1.58|3.2|||Mixed Model Repeated Measures Analysis|||A mixed effects model was applied with fixed effects for period, time, treatment, and the interaction between treatment and time. Baseline was included as 2 separate covariates. The interaction between each baseline covariate and time were included as fixed effects. Participant was fitted as a random effect and time was fitted as a repeated effect within each participant × period. An unstructured correlation matrix was used. The effect reported is an average across all post-dose measurements.||3.20|-1.58|
72519720|NCT02564029|144568946|OTHER||Mean Difference (Final Values)|-1.01|STANDARD_ERROR_OF_MEAN|1.4|||TWO_SIDED|90.0|-3.43|1.41|||Mixed Model Repreated Measure Analysis|||A mixed effects model was applied with fixed effects for period, time, treatment, and the interaction between treatment and time. Baseline was included as 2 separate covariates. The interaction between each baseline covariate and time were included as fixed effects. Participant was fitted as a random effect and time was fitted as a repeated effect within each participant × period. An unstructured correlation matrix was used. The effect reported is an average across all post-dose measurements.||1.41|-3.43|
72519721|NCT02564029|144568946|OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|1.36|||TWO_SIDED|90.0|-2.56|2.16|||Mixed Model Repeated Measures Analysis|||A mixed effects model was applied with fixed effects for period, time, treatment, and the interaction between treatment and time. Baseline was included as 2 separate covariates. The interaction between each baseline covariate and time were included as fixed effects. Participant was fitted as a random effect and time was fitted as a repeated effect within each participant × period. An unstructured correlation matrix was used. The effect reported is an average across all post-dose measurements.||2.16|-2.56|
72519722|NCT02564029|144568947|OTHER||Mean Difference (Final Values)|-6.23|STANDARD_ERROR_OF_MEAN|1.37|||TWO_SIDED|90.0|-8.6|-3.86|||Mixed Model Repeated Measure Analysis|||In eye closure condition. The same mixed model repeated measures analysis as applied to the primary outcome measure was used.||-3.86|-8.60|
72519723|NCT02564029|144568947|OTHER||Mean Difference (Final Values)|-5.42|STANDARD_ERROR_OF_MEAN|1.36|||TWO_SIDED|90.0|-7.78|-3.06|||Mixed Model Repeated Measures Analysis|||In eye closure condition. The same mixed model repeated measures analysis as applied to the primary outcome measure was used.||-3.06|-7.78|
72519724|NCT02564029|144568947|OTHER||Mean Difference (Final Values)|-5.22|STANDARD_ERROR_OF_MEAN|1.37|||TWO_SIDED|90.0|-7.6|-2.84|||Mixed Model Repeated Measures Analysis|||In eye closure condition. The same mixed model repeated measures analysis as applied to the primary outcome measure was used.||-2.84|-7.60|
72519725|NCT02564029|144568947|OTHER||Mean Difference (Final Values)|0.81|STANDARD_ERROR_OF_MEAN|1.38|||TWO_SIDED|90.0|-1.58|3.2|||Mixed Model Repeated Measures Analysis|||In eye closure condition. The same mixed model repeated measures analysis as applied to the primary outcome measure was used.||3.20|-1.58|
72519726|NCT02564029|144568947|OTHER||Mean Difference (Final Values)|-1.01|STANDARD_ERROR_OF_MEAN|1.4|||TWO_SIDED|90.0|-3.43|1.41|||Mixed Model Repeated Measures Analysis|||In eye closure condition. The same mixed model repeated measures analysis as applied to the primary outcome measure was used.||1.41|-3.43|
72569742|NCT02944383|144669996|SUPERIORITY|||||||0.2112||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.2112
72569743|NCT02944383|144669996|SUPERIORITY|||||||0.7301||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.7301
72569744|NCT02944383|144669996|SUPERIORITY|||||||0.6283||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.6283
72569745|NCT02944383|144669996|SUPERIORITY|||||||0.0919||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||EOS (average of week 10 and 12)||||0.0919
72569746|NCT02944383|144669996|SUPERIORITY|||||||0.5497||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||EOS (average of week 10 and 12)||||0.5497
72569747|NCT02944383|144669997|SUPERIORITY|||||||0.0009||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.0009
72569748|NCT02944383|144669997|SUPERIORITY|||||||0.0351||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.0351
72519727|NCT02564029|144568947|OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|1.36|||TWO_SIDED|90.0|-2.56|2.16|||Mixed Model Repeated Measures Analysis|||In eye closure condition. The same mixed model repeated measures analysis as applied to the primary outcome measure was used.||2.16|-2.56|
72519728|NCT02564029|144568947|OTHER||Mean Difference (Final Values)|-6.51|STANDARD_ERROR_OF_MEAN|0.79|||TWO_SIDED|90.0|-8.01|-5.01|||Mixed Model Repeated Measures Analysis|||In eyes closed condition. The same mixed model repeated measures analysis as applied to the primary outcome measure was used.||-5.01|-8.01|
72519729|NCT02564029|144568947|OTHER||Mean Difference (Final Values)|-6.44|STANDARD_ERROR_OF_MEAN|0.78|||TWO_SIDED|90.0|-7.93|-4.95|||Mixed Model Repeated Measures Analysis|||In eyes closed condition. The same mixed model repeated measures analysis as applied to the primary outcome measure was used.||-4.95|-7.93|
72519730|NCT02564029|144568947|OTHER||Mean Difference (Final Values)|-5.74|STANDARD_ERROR_OF_MEAN|0.76|||TWO_SIDED|90.0|-7.2|-4.28|||Mixed Model Repeated Measures Analysis|||In eyes closed condition. The same mixed model repeated measures analysis as applied to the primary outcome measure was used.||-4.28|-7.20|
72519731|NCT02564029|144568947|OTHER||Mean Difference (Final Values)|0.07|STANDARD_ERROR_OF_MEAN|0.72|||TWO_SIDED|90.0|-1.31|1.46|||Mixed Model Repeated Measures Analysis|||In eyes closed condition. The same mixed model repeated measures analysis as applied to the primary outcome measure was used.||1.46|-1.31|
72519732|NCT02564029|144568947|OTHER||Mean Difference (Final Values)|-0.77|STANDARD_ERROR_OF_MEAN|0.74|||TWO_SIDED|90.0|-2.19|0.65|||Mixed Model Repeated Measures Analysis|||In eyes closed condition. The same mixed model repeated measures analysis as applied to the primary outcome measure was used.||0.65|-2.19|
72519733|NCT02564029|144568947|OTHER||Mean Difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|0.72|||TWO_SIDED|90.0|-2.09|0.7|||Mixed Model Repeated Measures Analysis|||In eyes closed condition. The same mixed model repeated measures analysis as applied to the primary outcome measure was used.||0.70|-2.09|
72519734|NCT02564029|144568947|OTHER||Mean Difference (Final Values)|-4.42|STANDARD_ERROR_OF_MEAN|0.68|||TWO_SIDED|90.0|-5.6|-3.25|||Mixed Model Repeated Measures Analysis|||In eyes open condition. The same mixed model repeated measures analysis as applied to the primary outcome measure was used.||-3.25|-5.60|
72519735|NCT02564029|144568947|OTHER||Mean Difference (Final Values)|-4.37|STANDARD_ERROR_OF_MEAN|0.69|||TWO_SIDED|90.0|-5.57|-3.17|||Mixed Model Repeated Measures Analysis|||In eyes open condition. The same mixed model repeated measures analysis as applied to the primary outcome measure was used.||-3.17|-5.57|
72519736|NCT02564029|144568947|OTHER||Mean Difference (Final Values)|-4.38|STANDARD_ERROR_OF_MEAN|0.69|||TWO_SIDED|90.0|-5.57|-3.19|||Mixed Model Repeated Measures Analysis|||In eyes open condition. The same mixed model repeated measures analysis as applied to the primary outcome measure was used.||-3.19|-5.57|
72519737|NCT02564029|144568947|OTHER||Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.66|||TWO_SIDED|90.0|-1.08|1.19|||Mixed Model Repeated Measures Analysis|||In eyes open condition. The same mixed model repeated measures analysis as applied to the primary outcome measure was used.||1.19|-1.08|
72519738|NCT02564029|144568947|OTHER||Mean Difference (Final Values)|-0.04|STANDARD_ERROR_OF_MEAN|0.66|||TWO_SIDED|90.0|-1.18|1.1|||Mixed Model Repeated Measures Analysis|||In eyes open condition. The same mixed model repeated measures analysis as applied to the primary outcome measure was used.||1.10|-1.18|
72519739|NCT02564029|144568947|OTHER||Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.65|||TWO_SIDED|90.0|-1.11|1.13|||Mixed Model Repeated Measures Analysis|||In eyes open condition. The same mixed model repeated measures analysis as applied to the primary outcome measure was used.||1.13|-1.11|
72519740|NCT00617656|144568974|SUPERIORITY||Hazard Ratio (HR)|1.13||||0.56|TWO_SIDED|95.0|0.76|1.67|||Log Rank|||This is a futility analysis. The initial hypothesis of the clinical trial was that the experimental group as a whole was superior to the control group.||1.67|0.76|0.56
72569749|NCT02944383|144669997|SUPERIORITY|||||||0.1561||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.1561
72569750|NCT02944383|144669997|SUPERIORITY|||||||0.0268||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.0268
72569751|NCT02944383|144669997|SUPERIORITY||Median Difference (Net)|-22.3||||0.0516|TWO_SIDED|95.0|-42.96|-1.67||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|EOS (average of week 10 and 12)||-1.67|-42.96|0.0516
72519741|NCT00617656|144568974|SUPERIORITY||Hazard Ratio (HR)|1.05||||0.79|TWO_SIDED|95.0|0.73|1.51|||Log Rank|||||1.51|0.73|0.79
72519742|NCT00617656|144568974|SUPERIORITY||Hazard Ratio (HR)|2.02||||0.0001|TWO_SIDED|95.0|1.38|2.95|||Log Rank|||||2.95|1.38|0.0001
72519743|NCT00617656|144568975|SUPERIORITY||Hazard Ratio (HR)|1.55||||0.006|TWO_SIDED|95.0|1.13|2.12|||Log Rank|||||2.12|1.13|0.006
72519744|NCT01060098|144568994|SUPERIORITY|||||||0.003|||||||Wilcoxon (Mann-Whitney)|||week 0 compared to week 12||||0.003
72519745|NCT01060098|144568994|SUPERIORITY|||||||0.04|||||||Wilcoxon (Mann-Whitney)|||week 0 compared to week 12||||0.04
72519746|NCT01060098|144568994|SUPERIORITY|||||||0.48|||||||Wilcoxon (Mann-Whitney)|||week 0 compared to week 12||||0.48
72519747|NCT02688153|144568995|SUPERIORITY||Median Difference (Final Values)|-4.5||||0.366|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.3660
72519748|NCT02688153|144568996|SUPERIORITY||Median Difference (Final Values)|2.0||||0.8377|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.8377
72519749|NCT00107172|144569022|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|1.01||||0.98|TWO_SIDED|95.0|0.51|1.98|||Log Rank|Competing risk P-value = 0.91.||The competing risk analysis accounting for death/regional and distant recurrence as competing events was performed.||1.98|0.51|0.98
72519750|NCT00107172|144569023|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|1.07||||0.75|TWO_SIDED|95.0|0.71|1.61|||Log Rank|||||1.61|0.71|0.75
72519751|NCT00107172|144569028|SUPERIORITY_OR_OTHER_LEGACY|||||||0.37|TWO_SIDED||||||Fisher Exact|||Compare the grade 3+ adverse events incidence reported from day 0 to 30 between arms.||||0.37
72519752|NCT00107172|144569028|SUPERIORITY_OR_OTHER_LEGACY|||||||0.25|TWO_SIDED||||||Fisher Exact|||Compare the grade 3+ adverse events incidence reported from day 0 to 90 between arms.||||0.25
72519753|NCT00107172|144569029|SUPERIORITY_OR_OTHER_LEGACY|||||||0.35|TWO_SIDED||||||Fisher Exact|||Compare the grade 3+ respiratory adverse events incidence reported from day 0 to 30 between arms.||||0.35
72519754|NCT00107172|144569029|SUPERIORITY_OR_OTHER_LEGACY|||||||0.31|TWO_SIDED||||||Fisher Exact|||Compare the grade 3+ respiratory adverse events incidence reported from day 0 to 90 between arms.||||0.31
72519755|NCT00107172|144569032|SUPERIORITY_OR_OTHER_LEGACY|||||||0.03|TWO_SIDED||||||Wilcoxon Signed Rank|||Compare the percentage change from baseline to 3-month value for SR arm.||||0.03
72519756|NCT00107172|144569032|SUPERIORITY_OR_OTHER_LEGACY|||||||0.18|TWO_SIDED||||||Wilcoxon Signed Rank|||Compare the percentage change from baseline to 3-month value for SR + BX arm.||||0.18
72519757|NCT00107172|144569033|SUPERIORITY_OR_OTHER_LEGACY|||||||0.38|TWO_SIDED||||||Wilcoxon Signed Rank|||Compare the percentage change from baseline to 3-month value for SR arm.||||0.38
72519758|NCT00107172|144569033|SUPERIORITY_OR_OTHER_LEGACY|||||||0.16|TWO_SIDED||||||Wilcoxon Signed Rank|||Compare the percentage change from baseline to 3-month value for SR + BX arm.||||0.16
72569752|NCT02944383|144669997|SUPERIORITY||Median Difference (Net)|-13.06||||0.0125|TWO_SIDED|95.0|-32.83|4.88||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|EOS (average of week 10 and 12)||4.88|-32.83|0.0125
72569753|NCT02944383|144669998|SUPERIORITY|||||||0.0023||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.0023
72569754|NCT02944383|144669998|SUPERIORITY|||||||0.0356||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.0356
72405691|NCT03909165|144319743|OTHER||Geometric Mean Ratio (GMR)|0.89|||||TWO_SIDED|90.0|0.7|1.13||||||4 mg/kg AUC0-inf GMR = 3 to \< 6 months AUC0-inf GM / 6 months to \< 2 years AUC0-inf GM.||1.13|0.70|
72519759|NCT02061748|144569051|SUPERIORITY_OR_OTHER|||||||0.0111|||||||Chi-squared|||Study outcomes for the primary analysis were identified using either the admitting diagnoses or on any of the service lines associated with an inpatient hospitalization.||||0.0111
72519760|NCT02061748|144569052|SUPERIORITY_OR_OTHER|||||||0.0861|||||||Chi-squared|||The post-hoc analysis defined the principal diagnosis as the primary diagnosis on the first inpatient hospital claim with a room and board charge.||||0.0861
72519761|NCT02061748|144569053|SUPERIORITY_OR_OTHER|||||||0.0011|||||||Chi-squared|||Study outcomes for the primary analysis were identified using either the admitting diagnoses or on any of the service lines associated with an inpatient hospitalization.||||0.0011
72519762|NCT02061748|144569054|SUPERIORITY_OR_OTHER|||||||0.0019|||||||Chi-squared|||The post-hoc analysis defined the principal diagnosis as the primary diagnosis on the first inpatient hospital claim with a room and board charge.||||0.0019
72519763|NCT02061748|144569055|SUPERIORITY_OR_OTHER|||||||0.0808|||||||Chi-squared|||Study outcomes for the primary analysis were identified using either the admitting diagnoses or on any of the service lines associated with an inpatient hospitalization.||||0.0808
72519764|NCT02061748|144569056|SUPERIORITY_OR_OTHER|||||||0.3502|||||||Chi-squared|||The post-hoc analysis defined the principal diagnosis as the primary diagnosis on the first inpatient hospital claim with a room and board charge.||||0.3502
72519765|NCT02061748|144569057|SUPERIORITY_OR_OTHER|||||||0.0068|||||||Chi-squared|||Study outcomes for the primary analysis were identified using either the admitting diagnoses or on any of the service lines associated with an inpatient hospitalization.||||0.0068
72519766|NCT02061748|144569058|SUPERIORITY_OR_OTHER|||||||0.0271|||||||Chi-squared|||The post-hoc analysis defined the principal diagnosis as the primary diagnosis on the first inpatient hospital claim with a room and board charge.||||0.0271
72519767|NCT02061748|144569059|SUPERIORITY_OR_OTHER|||||||0.0749|||||||Chi-squared|||Study outcomes for the primary analysis were identified using either the admitting diagnoses or on any of the service lines associated with an inpatient hospitalization.||||0.0749
72519768|NCT02061748|144569060|SUPERIORITY_OR_OTHER|||||||0.0072|||||||Chi-squared|||The post-hoc analysis defined the principal diagnosis as the primary diagnosis on the first inpatient hospital claim with a room and board charge.||||0.0072
72519769|NCT02061748|144569061|SUPERIORITY_OR_OTHER|||||||0.0055|||||||Chi-squared|||Study outcomes for the primary analysis were identified using either the admitting diagnoses or on any of the service lines associated with an inpatient hospitalization.||||0.0055
72519770|NCT02061748|144569062|SUPERIORITY_OR_OTHER|||||||0.0284|||||||Chi-squared|||The post-hoc analysis defined the principal diagnosis as the primary diagnosis on the first inpatient hospital claim with a room and board charge.||||0.0284
72519771|NCT02061748|144569063|SUPERIORITY_OR_OTHER|||||||0.907|||||||Chi-squared|||Study outcomes for the primary analysis were identified using either the admitting diagnoses or on any of the service lines associated with an inpatient hospitalization.||||0.907
72519772|NCT02061748|144569064|SUPERIORITY_OR_OTHER|||||||0.8208|||||||Chi-squared|||The post-hoc analysis defined the principal diagnosis as the primary diagnosis on the first inpatient hospital claim with a room and board charge.||||0.8208
72519773|NCT02061748|144569065|SUPERIORITY_OR_OTHER|||||||0.1534|||||||Chi-squared|||Study outcomes for the primary analysis were identified using either the admitting diagnoses or on any of the service lines associated with an inpatient hospitalization.||||0.1534
72519774|NCT02061748|144569066|SUPERIORITY_OR_OTHER|||||||0.3055|||||||Chi-squared|||The post-hoc analysis defined the principal diagnosis as the primary diagnosis on the first inpatient hospital claim with a room and board charge.||||0.3055
72519775|NCT02061748|144569067|SUPERIORITY_OR_OTHER|||||||0.9573|||||||Chi-squared|||Study outcomes for the primary analysis were identified using either the admitting diagnoses or on any of the service lines associated with an inpatient hospitalization.||||0.9573
72519776|NCT02061748|144569068|SUPERIORITY_OR_OTHER|||||||0.8465|||||||Chi-squared|||The post-hoc analysis defined the principal diagnosis as the primary diagnosis on the first inpatient hospital claim with a room and board charge.||||0.8465
72519777|NCT02061748|144569069|SUPERIORITY_OR_OTHER|||||||0.0006|||||||Chi-squared|||Study outcomes for the primary analysis were identified using either the admitting diagnoses or on any of the service lines associated with an inpatient hospitalization.||||0.0006
72519778|NCT02061748|144569070|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Chi-squared|||The post-hoc analysis defined the principal diagnosis as the primary diagnosis on the first inpatient hospital claim with a room and board charge.||||<0.0001
72519779|NCT02061748|144569071|SUPERIORITY_OR_OTHER|||||||0.0185|||||||Chi-squared|||Study outcomes for the primary analysis were identified using either the admitting diagnoses or on any of the service lines associated with an inpatient hospitalization.||||0.0185
72624954|NCT02757768|144779451|SUPERIORITY||LS Mean of Difference|-2.9|STANDARD_ERROR_OF_MEAN|1.51||0.055|TWO_SIDED|95.0|-5.86|0.06|||ANCOVA|||Week 12 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||0.06|-5.86|0.055
72405692|NCT03909165|144319744|OTHER||Geometric Mean Ratio (GMR)|0.91|||||TWO_SIDED|90.0|0.67|1.23||||||2 mg/kg AUC0-1hr GMR = Birth to 27 days AUC0-1hr GM / 28 days to \< 3 months AUC0-1hr GM.||1.23|0.67|
72624955|NCT02757768|144779451|SUPERIORITY||LS Mean of Difference|-2.11|STANDARD_ERROR_OF_MEAN|1.48||0.154|TWO_SIDED|95.0|-5.02|0.8|||ANCOVA|||EoT Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||0.80|-5.02|0.154
72624956|NCT02757768|144779452|SUPERIORITY||LS Mean of Difference|-1.35|STANDARD_ERROR_OF_MEAN|1.13||0.233|TWO_SIDED|95.0|-3.57|0.87|||ANCOVA|||Week 4 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||0.87|-3.57|0.233
72624957|NCT02757768|144779452|SUPERIORITY||LS Mean of Difference|0.46|STANDARD_ERROR_OF_MEAN|1.2||0.698|TWO_SIDED|95.0|-1.89|2.82|||ANCOVA|||Week 8 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||2.82|-1.89|0.698
72519780|NCT02061748|144569072|SUPERIORITY_OR_OTHER|||||||0.0138|||||||Chi-squared|||The post-hoc analysis defined the principal diagnosis as the primary diagnosis on the first inpatient hospital claim with a room and board charge.||||0.0138
72519781|NCT02061748|144569073|SUPERIORITY_OR_OTHER|||||||0.261|||||||Chi-squared|||Study outcomes for the primary analysis were identified using either the admitting diagnoses or on any of the service lines associated with an inpatient hospitalization.||||0.261
72519782|NCT02061748|144569074|SUPERIORITY_OR_OTHER|||||||0.4407|||||||Chi-squared|||The post-hoc analysis defined the principal diagnosis as the primary diagnosis on the first inpatient hospital claim with a room and board charge.||||0.4407
72519783|NCT02061748|144569075|SUPERIORITY_OR_OTHER|||||||0.2665|||||||Chi-squared|||Study outcomes for the primary analysis were identified using either the admitting diagnoses or on any of the service lines associated with an inpatient hospitalization.||||0.2665
72519784|NCT02061748|144569076|SUPERIORITY_OR_OTHER|||||||0.8017|||||||Chi-squared|||The post-hoc analysis defined the principal diagnosis as the primary diagnosis on the first inpatient hospital claim with a room and board charge.||||0.8017
72519785|NCT02061748|144569077|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Chi-squared|||Study outcomes for the primary analysis were identified using either the admitting diagnoses or on any of the service lines associated with an inpatient hospitalization.||||<0.0001
72519786|NCT02061748|144569078|SUPERIORITY_OR_OTHER|||||||0.2083|||||||Chi-squared|||The post-hoc analysis defined the principal diagnosis as the primary diagnosis on the first inpatient hospital claim with a room and board charge.||||0.2083
72519787|NCT02061748|144569079|SUPERIORITY_OR_OTHER|||||||0.0023|||||||Chi-squared|||Study outcomes for the primary analysis were identified using either the admitting diagnoses or on any of the service lines associated with an inpatient hospitalization.||||0.0023
72519788|NCT02061748|144569080|SUPERIORITY_OR_OTHER|||||||0.5331|||||||Chi-squared|||The post-hoc analysis defined the principal diagnosis as the primary diagnosis on the first inpatient hospital claim with a room and board charge.||||0.5331
72519789|NCT02061748|144569081|SUPERIORITY_OR_OTHER|||||||0.0003|||||||Chi-squared|||Study outcomes for the primary analysis were identified using either the admitting diagnoses or on any of the service lines associated with an inpatient hospitalization.||||0.0003
72519790|NCT02061748|144569082|SUPERIORITY_OR_OTHER|||||||0.2646|||||||Chi-squared|||The post-hoc analysis defined the principal diagnosis as the primary diagnosis on the first inpatient hospital claim with a room and board charge.||||0.2646
72405693|NCT03909165|144319744|OTHER||Geometric Mean Ratio (GMR)|1.25|||||TWO_SIDED|90.0|0.92|1.69||||||2 mg/kg AUC0-1hr GMR = 28 days to \< 3 months AUC0-1hr GM / 3 to \< 6 months AUC0-1hr GM.||1.69|0.92|
72405694|NCT03909165|144319744|OTHER||Geometric Mean Ratio (GMR)|0.83|||||TWO_SIDED|90.0|0.64|1.08||||||2 mg/kg AUC0-1hr GMR = 3 to \< 6 months AUC0-1hr GM / 6 months to \< 2 years AUC0-1hr GM.||1.08|0.64|
72405695|NCT03909165|144319744|OTHER||Geometric Mean Ratio (GMR)|0.86|||||TWO_SIDED|90.0|0.7|1.06||||||4 mg/kg AUC0-1hr GMR = Birth to 27 days AUC0-1hr GM / 28 days to \< 3 months AUC0-1hr GM.||1.06|0.70|
72519791|NCT02061748|144569083|SUPERIORITY_OR_OTHER|||||||0.0004|||||||Chi-squared|||Study outcomes for the primary analysis were identified using either the admitting diagnoses or on any of the service lines associated with an inpatient hospitalization.||||0.0004
72519792|NCT02061748|144569084|SUPERIORITY_OR_OTHER|||||||0.0004|||||||Chi-squared|||The post-hoc analysis defined the principal diagnosis as the primary diagnosis on the first inpatient hospital claim with a room and board charge.||||0.0004
72519793|NCT03706040|144569090|SUPERIORITY||Adjusted Difference|13.0||||0.084|TWO_SIDED|95.0|-1.7|27.7|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by Baseline disease severity (moderate \[vIGA-AD 3\] versus severe \[vIGA-AD 4\]).|Between Group Difference = Risankizumab - Placebo|||27.7|-1.7|0.084
72519794|NCT03706040|144569090|SUPERIORITY||Adjusted Difference|10.0||||0.179|TWO_SIDED|95.0|-4.6|24.6|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by Baseline disease severity (moderate \[vIGA-AD 3\] versus severe \[vIGA-AD 4\]).|Between Group Difference = Risankizumab - Placebo|||24.6|-4.6|0.179
72519795|NCT03706040|144569091|SUPERIORITY||Adjusted Difference|8.7||||0.129|TWO_SIDED|95.0|-2.5|20.0|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by Baseline disease severity (moderate \[vIGA-AD 3\] versus severe \[vIGA-AD 4\]).|Between Group Difference = Risankizumab - Placebo|||20.0|-2.5|0.129
72519796|NCT03706040|144569091|SUPERIORITY||Adjusted Difference|0.0||||0.994|TWO_SIDED|95.0|-9.4|9.4|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by Baseline disease severity (moderate \[vIGA-AD 3\] versus severe \[vIGA-AD 4\]).|Between Group Difference = Risankizumab - Placebo|||9.4|-9.4|0.994
72519797|NCT03706040|144569092|SUPERIORITY||Adjusted Difference|13.7||||0.001|TWO_SIDED|95.0|5.4|22.1|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by Baseline disease severity (moderate \[vIGA-AD 3\] versus severe \[vIGA-AD 4\]).|Between Group Difference = Risankizumab - Placebo|||22.1|5.4|0.001
72519798|NCT03706040|144569092|SUPERIORITY||Adjusted Difference|15.3|||<|0.001|TWO_SIDED|95.0|6.6|24.0|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by Baseline disease severity (moderate \[vIGA-AD 3\] versus severe \[vIGA-AD 4\]).|Between Group Difference = Risankizumab - Placebo|||24.0|6.6|<0.001
72519799|NCT03706040|144569093|SUPERIORITY||Least Squares (LS) Mean Difference|-10.32|STANDARD_ERROR_OF_MEAN|11.073||0.353|TWO_SIDED|95.0|-32.25|11.61|||Mixed Effect Model Repeated Measurement|MMRM analysis with treatment, visit, treatment-by-visit interaction, vIGA-AD categories (moderate vs severe) and Baseline value in the model.|Between Group Difference = Risankizumab - Placebo|||11.61|-32.25|0.353
72519800|NCT03706040|144569093|SUPERIORITY||LS Mean Difference|-16.86|STANDARD_ERROR_OF_MEAN|11.305||0.139|TWO_SIDED|95.0|-39.24|5.53|||Mixed Effect Model Repeated Measurement|MMRM analysis with treatment, visit, treatment-by-visit interaction, vIGA-AD categories (moderate vs severe) and Baseline value in the model.|Between Group Difference = Risankizumab - Placebo|||5.53|-39.24|0.139
72519801|NCT03706040|144569096|SUPERIORITY||Adjusted Difference|12.9||||0.171|TWO_SIDED|95.0|-5.6|31.4|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by Baseline disease severity (moderate \[vIGA-AD 3\] versus severe \[vIGA-AD 4\]).|Between Group Difference = Risankizumab - Placebo|||31.4|-5.6|0.171
72519802|NCT03706040|144569096|SUPERIORITY||Adjusted Difference|5.7||||0.552|TWO_SIDED|95.0|-13.1|24.5|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by Baseline disease severity (moderate \[vIGA-AD 3\] versus severe \[vIGA-AD 4\]).|Between Group Difference = Risankizumab - Placebo|||24.5|-13.1|0.552
72519803|NCT03706040|144569098|SUPERIORITY||Adjusted Difference|11.6||||0.022|TWO_SIDED|95.0|1.7|21.6|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by Baseline disease severity (moderate \[vIGA-AD 3\] versus severe \[vIGA-AD 4\]).|Between Group Difference = Risankizumab - Placebo|||21.6|1.7|0.022
72519804|NCT03706040|144569098|SUPERIORITY||Adjusted Difference|5.8||||0.192|TWO_SIDED|95.0|-2.9|14.4|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by Baseline disease severity (moderate \[vIGA-AD 3\] versus severe \[vIGA-AD 4\]).|Between Group Difference = Risankizumab - Placebo|||14.4|-2.9|0.192
72519805|NCT03706040|144569101|SUPERIORITY||LS Mean Difference|-6.24|STANDARD_ERROR_OF_MEAN|4.506||0.169|TWO_SIDED|95.0|-15.15|2.68|||Mixed Effect Model Repeated Measurement|MMRM analysis with treatment, visit, treatment-by-visit interaction, vIGA-AD categories (moderate vs severe) and Baseline value in the model.|Between Group Difference = Risankizumab - Placebo|||2.68|-15.15|0.169
72519806|NCT03706040|144569101|SUPERIORITY||LS Mean Difference|-5.86|STANDARD_ERROR_OF_MEAN|4.589||0.204|TWO_SIDED|95.0|-14.94|3.22|||Mixed Effect Model Repeated Measurement|MMRM analysis with treatment, visit, treatment-by-visit interaction, vIGA-AD categories (moderate vs severe) and Baseline value in the model.|Between Group Difference = Risankizumab - Placebo|||3.22|-14.94|0.204
72519807|NCT03706040|144569103|SUPERIORITY||Adjusted Difference|6.7||||0.422|TWO_SIDED|95.0|-9.7|23.1|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by Baseline disease severity (moderate \[vIGA-AD 3\] versus severe \[vIGA-AD 4\]).|Between Group Difference = Risankizumab - Placebo|||23.1|-9.7|0.422
72519808|NCT03706040|144569103|SUPERIORITY||Adjusted Difference|-5.2||||0.505|TWO_SIDED|95.0|-20.3|10.0|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by Baseline disease severity (moderate \[vIGA-AD 3\] versus severe \[vIGA-AD 4\]).|Between Group Difference = Risankizumab - Placebo|||10.0|-20.3|0.505
72569755|NCT02944383|144669998|SUPERIORITY|||||||0.2284||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.2284
72569756|NCT02944383|144669998|SUPERIORITY|||||||0.0213||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.0213
72569757|NCT02944383|144669998|SUPERIORITY|||||||0.033||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||EOS (average of week 10 and 12)||||0.0330
72569758|NCT02944383|144669998|SUPERIORITY|||||||0.0221||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||EOS (average of week 10 and 12)||||0.0221
72519809|NCT03706040|144569105|SUPERIORITY||Adjusted Difference|10.1||||0.005|TWO_SIDED|95.0|3.0|17.3|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by Baseline disease severity (moderate \[vIGA-AD 3\] versus severe \[vIGA-AD 4\]).|Between Group Difference = Risankizumab - Placebo|||17.3|3.0|0.005
72569759|NCT02944383|144669999|SUPERIORITY||Median Difference (Net)|-2.67||||0.2632|TWO_SIDED|95.0|-10.17|5.67||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|VLDL||5.67|-10.17|0.2632
72569760|NCT02944383|144669999|SUPERIORITY||Median Difference (Net)|2.02||||0.5382|TWO_SIDED|95.0|-6.77|9.71||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|VLDL||9.71|-6.77|0.5382
72569761|NCT02944383|144669999|SUPERIORITY||Median Difference (Net)|0.0||||0.1727|TWO_SIDED|95.0|-0.51|1.01||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|LDL||1.01|-0.51|0.1727
72569762|NCT02944383|144669999|SUPERIORITY||Median Difference (Net)|0.0||||0.4567|TWO_SIDED|95.0|-0.51|0.51||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|LDL||0.51|-0.51|0.4567
72405696|NCT03909165|144319744|OTHER||Geometric Mean Ratio (GMR)|1.07|||||TWO_SIDED|90.0|0.89|1.29||||||4 mg/kg AUC0-1hr GMR = 28 days to \< 3 months AUC0-1hr GM / 3 to \< 6 months AUC0-1hr GM.||1.29|0.89|
72405697|NCT03909165|144319744|OTHER||Geometric Mean Ratio (GMR)|0.97|||||TWO_SIDED|90.0|0.8|1.17||||||4 mg/kg AUC0-1hr GMR = 3 to \< 6 months AUC0-1hr GM / 6 months to \< 2 years AUC0-1hr GM.||1.17|0.80|
72405698|NCT03909165|144319746|OTHER||Geometric Mean Ratio (GMR)|0.92|||||TWO_SIDED|90.0|0.61|1.4||||||2 mg/kg Cmax GMR = Birth to 27 days Cmax GM / 28 days to \< 3 months Cmax GM.||1.40|0.61|
72405699|NCT03909165|144319746|OTHER||Geometric Mean Ratio (GMR)|1.09|||||TWO_SIDED|90.0|0.7|1.7||||||2 mg/kg Cmax GMR = 28 days to \< 3 months Cmax GM / 3 to \< 6 months Cmax GM.||1.70|0.70|
72405700|NCT03909165|144319746|OTHER||Geometric Mean Ratio (GMR)|0.92|||||TWO_SIDED|90.0|0.63|1.36||||||2 mg/kg Cmax GMR = 3 to \< 6 months Cmax GM / 6 months to \< 2 years Cmax GM.||1.36|0.63|
72405701|NCT03909165|144319746|OTHER||Geometric Mean Ratio (GMR)|0.94|||||TWO_SIDED|90.0|0.7|1.26||||||4 mg/kg Cmax GMR = Birth to 27 days Cmax GM / 28 days to \< 3 months Cmax GM.||1.26|0.70|
72519810|NCT03706040|144569105|SUPERIORITY||Adjusted Difference|2.9||||0.151|TWO_SIDED|95.0|-1.1|6.8|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by Baseline disease severity (moderate \[vIGA-AD 3\] versus severe \[vIGA-AD 4\]).|Between Group Difference = Risankizumab - Placebo|||6.8|-1.1|0.151
72519811|NCT03706040|144569107|SUPERIORITY||Adjusted Difference|5.9||||0.035|TWO_SIDED|95.0|0.4|11.3|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by Baseline disease severity (moderate \[vIGA-AD 3\] versus severe \[vIGA-AD 4\]).|Between Group Difference = Risankizumab - Placebo|||11.3|0.4|0.035
72519812|NCT03706040|144569107|SUPERIORITY||Adjusted Difference|1.5||||0.311|TWO_SIDED|95.0|-1.4|4.4|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by Baseline disease severity (moderate \[vIGA-AD 3\] versus severe \[vIGA-AD 4\]).|Between Group Difference = Risankizumab - Placebo|||4.4|-1.4|0.311
72519813|NCT03706040|144569109|SUPERIORITY||Adjusted Difference|-0.3||||0.965|TWO_SIDED|95.0|-12.0|11.5|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by Baseline disease severity (moderate \[vIGA-AD 3\] versus severe \[vIGA-AD 4\]).|Between Group Difference = Risankizumab - Placebo|||11.5|-12.0|0.965
72569763|NCT02944383|144669999|SUPERIORITY||Median Difference (Net)|0.0||||0.6142|TWO_SIDED|95.0|-1.21|1.47||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|HDL||1.47|-1.21|0.6142
72569764|NCT02944383|144669999|SUPERIORITY||Median Difference (Net)|-0.02||||0.2409|TWO_SIDED|95.0|-2.23|1.29||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|HDL||1.29|-2.23|0.2409
72569765|NCT02944383|144670000|SUPERIORITY|||||||0.2721||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||VLDL||||0.2721
72569766|NCT02944383|144670000|SUPERIORITY|||||||0.5669||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||VLDL||||0.5669
72569767|NCT02944383|144670000|SUPERIORITY|||||||0.1686||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||LDL||||0.1686
72569768|NCT02944383|144670000|SUPERIORITY|||||||0.4308||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||LDL||||0.4308
72405702|NCT03909165|144319746|OTHER||Geometric Mean Ratio (GMR)|0.68|||||TWO_SIDED|90.0|0.52|0.89||||||4 mg/kg Cmax GMR = 28 days to \< 3 months Cmax GM / 3 to \< 6 months Cmax GM.||0.89|0.52|
72519814|NCT03706040|144569109|SUPERIORITY||Adjusted Difference|-3.1||||0.583|TWO_SIDED|95.0|-14.3|8.1|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by Baseline disease severity (moderate \[vIGA-AD 3\] versus severe \[vIGA-AD 4\]).|Between Group Difference = Risankizumab - Placebo|||8.1|-14.3|0.583
72519815|NCT03706040|144569113|SUPERIORITY||Adjusted Difference|5.9||||0.539|TWO_SIDED|95.0|-13.0|24.9|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by Baseline disease severity (moderate \[vIGA-AD 3\] versus severe \[vIGA-AD 4\]).|Between Group Difference = Risankizumab - Placebo|||24.9|-13.0|0.539
72519816|NCT03706040|144569113|SUPERIORITY||Adjusted Difference|12.2||||0.213|TWO_SIDED|95.0|-7.0|31.5|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by Baseline disease severity (moderate \[vIGA-AD 3\] versus severe \[vIGA-AD 4\]).|Between Group Difference = Risankizumab - Placebo|||31.5|-7.0|0.213
72519817|NCT03706040|144569115|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|1.82||0.988|TWO_SIDED|95.0|-3.6|3.6|||Mixed Effect Model Repeated Measurement|MMRM analysis with treatment, visit, treatment-by-visit interaction, vIGA-AD categories (moderate vs severe) and Baseline value in the model.|Between Group Difference = Risankizumab - Placebo|||3.6|-3.6|0.988
72519818|NCT03706040|144569115|SUPERIORITY||LS Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|1.86||0.594|TWO_SIDED|95.0|-4.7|2.7|||Mixed Effect Model Repeated Measurement|MMRM analysis with treatment, visit, treatment-by-visit interaction, vIGA-AD categories (moderate vs severe) and Baseline value in the model.|Between Group Difference = Risankizumab - Placebo|||2.7|-4.7|0.594
72519819|NCT03706040|144569119|SUPERIORITY||LS Mean Difference|-1.318|STANDARD_ERROR_OF_MEAN|0.6137||0.033|TWO_SIDED|95.0|-2.531|-0.105|||Mixed Effect Model Repeated Measurement|MMRM analysis with treatment, visit, treatment-by-visit interaction, vIGA-AD categories (moderate vs severe) and Baseline value in the model.|Between Group Difference = Risankizumab - Placebo|||-0.105|-2.531|0.033
72519820|NCT03706040|144569119|SUPERIORITY||LS Mean Difference|-1.648|STANDARD_ERROR_OF_MEAN|0.626||0.009|TWO_SIDED|95.0|-2.885|-0.411|||Mixed Effect Model Repeated Measurement|MMRM analysis with treatment, visit, treatment-by-visit interaction, vIGA-AD categories (moderate vs severe) and Baseline value in the model.|Between Group Difference = Risankizumab - Placebo|||-0.411|-2.885|0.009
72519821|NCT03788616|144569129|EQUIVALENCE|assuming 95% power of the study|Median Difference (Final Values)|0.05||||0.478|TWO_SIDED|95.0|||||t-test, 2 sided|||||||0.478
72405703|NCT03909165|144319746|OTHER||Geometric Mean Ratio (GMR)|1.09|||||TWO_SIDED|90.0|0.83|1.43||||||4 mg/kg AUC0-1hr GMR = 3 to \< 6 months Cmax GM / 6 months to \< 2 years Cmax GM.||1.43|0.83|
72405704|NCT03909165|144319751|SUPERIORITY||Hazard Ratio (HR)|2.4|||=|0.0002|TWO_SIDED|95.0|1.37|4.18||Two-sided p-value based on log-rank test stratified by neuromuscular blocking agent and age groups.|Log Rank|||The Hazard Ratio (HR) for the pairwise comparison of Sugammadex 2 mg/kg vs. Neostigmine + (Glycopyrrolate or Atropine) was based on a Cox regression model with Efron's method of tie handling with covariates of treatment, age (continuous) and stratified by neuromuscular blocking agent.||4.18|1.37|= 0.0002
72405705|NCT03909165|144319752|OTHER||Difference in Percentage|7.6|||||TWO_SIDED|95.0|-14.2|29.5||||||The difference in percentage of participants with an AE in sugammadex 2 mg/kg group versus the Neostigmine + (Glycopyrrolate or Atropine) group was based on the Miettinen and Nurminen method stratified by neuromuscular blocking agent and age group.||29.5|-14.2|
72405706|NCT03909165|144319752|OTHER||Difference in Percentage|5.9|||||TWO_SIDED|95.0|-13.5|26.7||||||The difference in percentage of participants with an AE in sugammadex 4 mg/kg group versus the Neostigmine + (Glycopyrrolate or Atropine) group was based on the Miettinen and Nurminen method stratified by neuromuscular blocking agent and age group.||26.7|-13.5|
72405707|NCT04609020|144319754|SUPERIORITY||Mean Difference (Final Values)|46.6|STANDARD_DEVIATION|23.61|<|0.0001|ONE_SIDED|97.5|40.58|||P-value is calculated based on 1-sided t-test or Wilcoxon signed-rank test (if the normality assumption is not met) at 0.025 significance level.|t-test, 1 sided||||||40.58|<0.0001
72405708|NCT04609020|144319755|SUPERIORITY||Mean Difference (Final Values)|35.3|STANDARD_DEVIATION|22.36|<|0.0001|ONE_SIDED|97.5|29.61|||P-value is calculated based on 1-sided t-test or Wilcoxon signed-rank test (if the normality assumption is not met) at 0.025 significance level.|t-test, 1 sided||||||29.61|<0.0001
72405709|NCT04609020|144319756|SUPERIORITY||Mean Difference (Final Values)|27.6|STANDARD_DEVIATION|23.23|<|0.0001|ONE_SIDED|97.5|21.5|||P-value is calculated based on 1-sided t-test or Wilcoxon signed-rank test (if the normality assumption is not met) at 0.025 significance level.|t-test, 1 sided||||||21.50|<0.0001
72569769|NCT02944383|144670000|SUPERIORITY|||||||0.5495||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||HDL||||0.5495
72569770|NCT02944383|144670000|SUPERIORITY|||||||0.2384||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||HDL||||0.2384
72569771|NCT02944383|144670001|SUPERIORITY||Median Difference (Net)|-13.99||||0.0781|TWO_SIDED|95.0|-33.76|2.55||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|VLDL \& Chylomicron particles||2.55|-33.76|0.0781
72569772|NCT02944383|144670001|SUPERIORITY||Median Difference (Net)|-2.1||||0.9901|TWO_SIDED|95.0|-19.36|19.01||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|VLDL \& Chylomicron particles||19.01|-19.36|0.9901
72569773|NCT02944383|144670001|SUPERIORITY||Median Difference (Net)|-25.23||||0.0717|TWO_SIDED|95.0|-43.62|-5.1||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|LDL Particles||-5.10|-43.62|0.0717
72405710|NCT04609020|144319757|SUPERIORITY||Mean Difference (Final Values)|22.9|STANDARD_DEVIATION|20.56|<|0.0001|ONE_SIDED|97.5|17.65|||P-value is calculated based on 1-sided t-test or Wilcoxon signed-rank test (if the normality assumption is not met) at 0.025 significance level.|t-test, 1 sided||||||17.65|<0.0001
72405711|NCT04609020|144319758|SUPERIORITY||Mean Difference (Final Values)|43.1|STANDARD_DEVIATION|22.25|<|0.0001|ONE_SIDED|97.5|37.48|||P-value is calculated based on 1-sided t-test or Wilcoxon signed-rank test (if the normality assumption is not met) at 0.025 significance level.|t-test, 1 sided||||||37.48|<0.0001
72405712|NCT02107599|144319766|SUPERIORITY_OR_OTHER|||||||0.0001|TWO_SIDED||||||Asymptotic Z-test|||||||0.0001
72405713|NCT02107599|144319767|SUPERIORITY_OR_OTHER|||||||0.006|TWO_SIDED||||||Monte Carlo test|||Evaluate whether the VisQ interpretation significantly improves the reliability of Amyvid Scan interpretation.||||0.0060
72405714|NCT02107599|144319767|SUPERIORITY_OR_OTHER|||||||0.1229|TWO_SIDED||||||Monte Carlo test|||Evaluate whether the VisQ interpretation significantly improves the reliability of Amyvid Scan interpretation.||||0.1229
72405715|NCT02107599|144319767|SUPERIORITY_OR_OTHER|||||||0.026|TWO_SIDED||||||Monte Carlo test|||Evaluate whether the VisQ interpretation significantly improves the reliability of Amyvid Scan interpretation.||||0.0260
72405716|NCT01806896|144319912|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.71|STANDARD_ERROR_OF_MEAN|1.68||0.68|TWO_SIDED|90.0|-3.56|2.15||2-sided p-value|ANCOVA|Treatment differences are based on a mixed effect model including treatment as fixed effects and baseline, age, gender and CAG repeats as covariates.||PF-02545920 versus Placebo (Day 28)||2.15|-3.56|0.68
72519822|NCT01783470|144569137|EQUIVALENCE|All p values presented are two tailed. p values \< 0.05 were considered to indicate statistical significance for the primary outcome.||||||0.001|||||||Wilcoxon sign-ranks test|||Since the sample size of twelve subjects limited the ability to demonstrate that measurements were normally distributed, we used the non-parametric Wilcoxon sign-ranks test to assess the primary and secondary endpoints. All p values presented are two tailed. p values \< 0.05 were considered to indicate statistical significance for the primary outcome.||||0.001
72519823|NCT00247273|144569139|NON_INFERIORITY_OR_EQUIVALENCE|In order to establish noninferiority for the primary efficacy variable at one-sided α of 2.5% with 90% power, a total of 1068 patients, 534 per treatment group, is required. This calculation is based on the following assumptions: the noninferiority margin (or delta) = 1.5%, the common SD (standard deviation) of the percent change from baseline in lumbar spine BMD at Month 12 = 4.5%, the 1 year dropout rate = 20%, and the true mean difference μD - μM = 0.5%.|Least Square (LS) Mean Difference|-0.115|||||TWO_SIDED|95.0|-0.505|0.274|||ANOVA|Fixed effects for treatment and pooled center||||0.274|-0.505|
72519824|NCT00247273|144569140|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.076|||||TWO_SIDED|95.0|-0.475|0.323|||ANOVA|Fixed effects for treatment and pooled center.||||0.323|-0.475|
72519825|NCT00247273|144569141|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.0005|||||TWO_SIDED|95.0|-0.0035|0.0024|||ANOVA|Fixed effects for treatment and pooled center.||||0.0024|-0.0035|
72519826|NCT00247273|144569142|NON_INFERIORITY_OR_EQUIVALENCE|The estimates of the common SD, dropout rate at month 24 and true difference are also based on previous risedronate Phase III studies (RVN008993, RVE009093, ROE009394, HMR4003E/3001).|LS Mean Difference|-0.239|||||TWO_SIDED|95.0|-0.727|0.249|||ANOVA|Fixed effects for treatment and pooled centers.||The sample size of 1068 patients will provide approximately 90% power to demonstrate the noninferiority of the monthly regimen at month 24, using a 2% noninferiority margin and assuming a common SD of the percent change from baseline in lumbar spine BMD at month 24 of 5%, a 2-year dropout rate of 30%, and a true mean difference (uDaily-uMonthly) of 0.8%.||0.249|-0.727|
72519827|NCT00247273|144569143|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.085|||||TWO_SIDED|95.0|-0.609|0.439|||ANOVA|Fixed Effects for treatment \& pooled center||||0.439|-0.609|
72519828|NCT00247273|144569144|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.0009|||||TWO_SIDED|95.0|-0.0048|0.0029|||ANOVA|Fixed effects for treatment and pooled center.||||0.0029|-0.0048|
72519829|NCT00247273|144569145|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.23|||||TWO_SIDED|95.0|-2.83|3.28|||ANOVA|Fixed effects for treatment and pooled center.||||3.28|-2.83|
72519830|NCT00247273|144569146|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.57|||||TWO_SIDED|95.0|-4.47|1.33|||ANOVA|Fixed effects for treatment and pooled center||||1.33|-4.47|
72519831|NCT00247273|144569147|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.0|||||TWO_SIDED|95.0|-2.54|4.53|||ANOVA|Fixed effects for treatment and pooled center||||4.53|-2.54|
72519832|NCT00247273|144569148|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.83|||||TWO_SIDED|95.0|-6.45|0.8|||ANOVA|Fixed effects for treatment and pooled center.||||0.80|-6.45|
72519833|NCT00247273|144569149|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02|||||TWO_SIDED|95.0|-0.05|0.0|||ANOVA|Fixed effects for treatment and pooled center||||0.00|-0.05|
72519834|NCT00247273|144569150|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.17|||||TWO_SIDED|95.0|-7.98|-0.36|||ANOVA|Fixed effects for treatment and pooled center||||-0.36|-7.98|
72519835|NCT00247273|144569151|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02|||||TWO_SIDED|95.0|-0.06|0.01|||ANOVA|Fixed effects for treatment and pooled center||||0.01|-0.06|
72519836|NCT00247273|144569152|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.69|||||TWO_SIDED|95.0|-12.04|0.66|||ANOVA|Fixed effects for treatment and pooled center||||0.66|-12.04|
72519837|NCT00247273|144569153|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.17|||||TWO_SIDED|95.0|-0.29|0.64|||ANOVA|Fixed effects for treatment and pooled center||||0.64|-0.29|
72519838|NCT00247273|144569154|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.31|||||TWO_SIDED|95.0|-0.85|3.48|||ANOVA|Fixed effects for treatment and pooled center||||3.48|-0.85|
72519839|NCT00247273|144569155|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.12|||||TWO_SIDED|95.0|-0.45|0.7|||ANOVA|Fixed effects for treatment and pooled center||||0.70|-0.45|
72519840|NCT00247273|144569156|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.77|||||TWO_SIDED|95.0|-3.96|2.43|||ANOVA|Fixed effects for treatment and pooled center||||2.43|-3.96|
72519841|NCT00247273|144569157|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.96||||1|TWO_SIDED|95.0|0.36|2.54|||Fisher Exact|||||2.54|0.36|1.0000
72569774|NCT02944383|144670001|SUPERIORITY||Median Difference (Net)|-16.09||||0.1548|TWO_SIDED|95.0|-36.78|3.76||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|LDL Particles||3.76|-36.78|0.1548
72519842|NCT00247273|144569158|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.98||||1|TWO_SIDED|95.0|0.47|2.03|||Fisher Exact|||||2.03|0.47|1.0000
72519843|NCT01510834|144569159|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.824|STANDARD_DEVIATION|14.148||0.001|TWO_SIDED|95.0|-10.578|-3.07|||t-test, 2 sided|||||-3.070|-10.578|.001
72519844|NCT01510834|144569160|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.0872|STANDARD_DEVIATION|15.731||0.001|TWO_SIDED|95.0|2.91|11.26|||t-test, 2 sided|||||11.26|2.91|.001
72519845|NCT01510834|144569161|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.78|STANDARD_DEVIATION|7.78|<|0.001|TWO_SIDED|95.0|-5.84|-1.7|||t-test, 2 sided|||||-1.70|-5.84|<.001
72519846|NCT01510834|144569162|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.08|STANDARD_DEVIATION|6.269||0.015|TWO_SIDED|95.0|-3.751|-0.4244|||t-test, 2 sided|||||-.4244|-3.751|.015
72519847|NCT02657434|144569170|OTHER|Unstratified Analysis|Hazard Ratio, log|0.562|||<|0.0001|TWO_SIDED|95.0|0.471|0.671|||Log Rank|||||0.671|0.471|<0.0001
72519848|NCT02657434|144569171|SUPERIORITY|Unstratified Analysis|Hazard Ratio (HR)|0.866||||0.1559|TWO_SIDED|95.0|0.709|1.056|||Log Rank|||||1.056|0.709|0.1559
72519849|NCT02657434|144569171|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.864||||0.1546|TWO_SIDED|95.0|0.707|1.056|||Log Rank|||||1.056|0.707|0.1546
72519850|NCT02657434|144569172|SUPERIORITY||Difference in event free rate|4.68||||0.2606|TWO_SIDED|95.0|-3.47|12.83|||z test|||||12.83|-3.47|0.2606
72519851|NCT02657434|144569173|SUPERIORITY||Difference in Event Free Rate|5.12||||0.209|TWO_SIDED|95.0|-2.87|13.11|||Z-test|||||13.11|-2.87|0.2090
72519852|NCT02657434|144569174|SUPERIORITY||Difference in response rate|14.3||||0.0005|TWO_SIDED|95.0|5.9|22.7|||Cochran-Mantel-Haenszel|||||22.7|5.9|0.0005
72519853|NCT02657434|144569175|SUPERIORITY||Hazard Ratio (HR)|0.62||||0.0024|TWO_SIDED|95.0|0.45|0.85|||Log Rank|||||0.85|0.45|0.0024
72405717|NCT01806896|144319914|SUPERIORITY_OR_OTHER||Least square mean|-0.1|STANDARD_ERROR_OF_MEAN|0.36||0.79|TWO_SIDED|90.0|-0.72|0.52||2-sided p-value|ANCOVA|Treatment differences are based on a mixed effect model including treatment as fixed effect and baseline, age, gender and CAG repeats as covariates.||PF-02545920 versus Placebo (Cue Rew\>Neut Left VS)||0.52|-0.72|0.79
72405718|NCT01806896|144319914|SUPERIORITY_OR_OTHER||Least square mean|-0.15|STANDARD_ERROR_OF_MEAN|0.37||0.7|TWO_SIDED|90.0|-0.8|0.51||2-sided p-value|ANCOVA|Treatment differences are based on a mixed effect model including treatment as fixed effect and baseline, age, gender and CAG repeats as covariates.||PF-02545920 versus Placebo (Cue Rew\>Neut Right VS)||0.51|-0.80|0.70
72519854|NCT01628393|144569185|SUPERIORITY||||||<|0.0001||||||To account for multiple comparisons, each of the 2 treatment comparisons was tested at the alpha = 0.04944 level of significance to keep the overall level of significance at 0.05.|Wilcoxon (Mann-Whitney)|Wilcoxon-Mann-Whitney test stratified by absence or presence of gadolinium-enhancing lesions at Baseline.||||||<0.0001
72519855|NCT01628393|144569185|SUPERIORITY||||||<|0.0001||||||To account for multiple comparisons, each of the 2 treatment comparisons was tested at the alpha = 0.04944 level of significance to keep the overall level of significance at 0.05.|Wilcoxon (Mann-Whitney)|Wilcoxon-Mann-Whitney test stratified by absence or presence of gadolinium-enhancing lesions at Baseline.||||||<0.0001
72519856|NCT01628393|144569186|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|Wilcoxon-Mann-Whitney test stratified by absence or presence of gadolinium-enhancing lesions at Baseline.||||||<0.0001
72519857|NCT01628393|144569186|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|Wilcoxon-Mann-Whitney test stratified by absence or presence of gadolinium-enhancing lesions at Baseline.||||||<0.0001
72519858|NCT01628393|144569187|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|Wilcoxon-Mann-Whitney test stratified by absence or presence of gadolinium-enhancing lesions at Baseline.||||||<0.0001
72519859|NCT01628393|144569187|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|Wilcoxon-Mann-Whitney test stratified by absence or presence of gadolinium-enhancing lesions at Baseline.||||||<0.0001
72519860|NCT01628393|144569188|SUPERIORITY||Rate Ratio|0.47||||0.0531|TWO_SIDED|95.0|0.22|1.01|||Poisson regression model|Adjusted for region, the number of relapses within 24 months prior to the study, and the absence or presence of GdE lesions at Baseline.|Rate ratio = Ozanimod / Placebo|||1.01|0.22|0.0531
72519861|NCT01628393|144569188|SUPERIORITY||Rate Ratio|0.69||||0.2714|TWO_SIDED|95.0|0.36|1.34|||Poisson regression model|Adjusted for region, the number of relapses within 24 months prior to the study, and the absence or presence of GdE lesions at Baseline.|Rate ratio = Ozanimod / Placebo|||1.34|0.36|0.2714
72519862|NCT01989754|144569200|SUPERIORITY||Hazard Ratio (HR)|0.64|||<|0.0001|TWO_SIDED|95.0|0.57|0.73|||Cox proportional hazard method|||||0.73|0.57|<.0001
72519863|NCT01989754|144569201|SUPERIORITY||Hazard Ratio (HR)|0.72|||=|0.0148|TWO_SIDED|95.0|0.55|0.94|||Stratified Cox proportional hazard|||||0.94|0.55|=0.0148
72519864|NCT01989754|144569202|SUPERIORITY||Hazard Ratio (HR)|0.86|||=|0.4067|TWO_SIDED|95.0|0.61|1.22|||Stratified Cox proportional hazard|||||1.22|0.61|=0.4067
72519865|NCT02980692|144569232|SUPERIORITY|||||||0.0001|||||||Cochran-Mantel-Haenszel|||||||0.0001
72519866|NCT02980692|144569232|SUPERIORITY|||||||0.0006|||||||Cochran-Mantel-Haenszel|||||||0.0006
72405719|NCT01806896|144319914|SUPERIORITY_OR_OTHER||Least square mean|-0.25|STANDARD_ERROR_OF_MEAN|0.37||0.51|TWO_SIDED|90.0|-0.89|0.4||2-sided p-value|ANCOVA|Treatment differences are based on a mixed effect model including treatment as fixed effect and baseline, age, gender and CAG repeats as covariates.||PF-02545920 versus Placebo (Out\_win\_Rew\>Out\_win N Left VS)||0.40|-0.89|0.51
72405720|NCT01806896|144319914|SUPERIORITY_OR_OTHER||Least square mean|-0.53|STANDARD_ERROR_OF_MEAN|0.33||0.13|TWO_SIDED|90.0|-1.1|0.04||2-sided p-value|ANCOVA|Treatment differences are based on a mixed effect model including treatment as fixed effect and baseline, age, gender and CAG repeats as covariates.||PF-02545920 versus Placebo (Out\_win\_Rew\>Out\_win N Right VS)||0.04|-1.10|0.13
72519867|NCT02980692|144569232|SUPERIORITY|||||||0.0088|||||||Cochran-Mantel-Haenszel|||||||0.0088
72519868|NCT02980692|144569232|SUPERIORITY|||||||0.0041|||||||Cochran-Mantel-Haenszel|||||||0.0041
72519869|NCT02980692|144569233|SUPERIORITY||% response rate|92.54|STANDARD_ERROR_OF_MEAN|3.21|||TWO_SIDED|95.0|86.24|98.83||||||||98.83|86.24|
72519870|NCT02980692|144569233|SUPERIORITY||% response rate|89.06|STANDARD_ERROR_OF_MEAN|3.9|||TWO_SIDED|95.0|81.42|96.71||||||||96.71|81.42|
72519871|NCT02980692|144569233|SUPERIORITY||% response rate|86.67|STANDARD_ERROR_OF_MEAN|4.39|||TWO_SIDED|95.0|78.07|95.27||||||||95.27|78.07|
72519872|NCT02980692|144569233|SUPERIORITY||% response rate|81.33|STANDARD_ERROR_OF_MEAN|4.5|||TWO_SIDED|95.0|72.52|90.15||||||||90.15|72.52|
72519873|NCT02980692|144569233|SUPERIORITY||% response rate|81.33|STANDARD_ERROR_OF_MEAN|4.5|||TWO_SIDED|95.0|72.52|90.15||||||||90.15|72.52|
72519874|NCT02980692|144569234|SUPERIORITY||% response rate|79.1|STANDARD_ERROR_OF_MEAN|4.97|||TWO_SIDED|95.0|69.37|88.84||||||||88.84|69.37|
72519875|NCT02980692|144569234|SUPERIORITY||% response rate|75.0|STANDARD_ERROR_OF_MEAN|5.41|||TWO_SIDED|95.0|64.39|85.61||||||||85.61|64.39|
72519876|NCT02980692|144569234|SUPERIORITY||% response rate|72.13|STANDARD_ERROR_OF_MEAN|5.74|||TWO_SIDED|95.0|60.88|83.38||||||||83.38|60.88|
72519877|NCT02980692|144569234|SUPERIORITY||% response rate|68.0|STANDARD_ERROR_OF_MEAN|5.39|||TWO_SIDED|95.0|57.44|78.56||||||||78.56|57.44|
72519878|NCT02980692|144569234|SUPERIORITY||% response rate|62.67|STANDARD_ERROR_OF_MEAN|5.59|||TWO_SIDED|95.0|51.72|73.61||||||||73.61|51.72|
72519879|NCT02980692|144569235|SUPERIORITY||% response rate|58.21|STANDARD_ERROR_OF_MEAN|6.03|||TWO_SIDED|95.0|46.4|70.02||||||||70.02|46.40|
72519880|NCT02980692|144569235|SUPERIORITY||% response rate|48.44|STANDARD_ERROR_OF_MEAN|6.25|||TWO_SIDED|95.0|36.19|60.68||||||||60.68|36.19|
72519881|NCT02980692|144569235|SUPERIORITY||% response rate|39.34|STANDARD_ERROR_OF_MEAN|6.25|||TWO_SIDED|95.0|27.09|51.6||||||||51.60|27.09|
72519882|NCT02980692|144569235|SUPERIORITY||% response rate|40.0|STANDARD_ERROR_OF_MEAN|5.66|||TWO_SIDED|95.0|28.91|51.09||||||||51.09|28.91|
72519883|NCT02980692|144569235|SUPERIORITY||% response rate|37.33|STANDARD_ERROR_OF_MEAN|5.59|||TWO_SIDED|95.0|26.39|48.28||||||||48.28|26.39|
72519884|NCT02980692|144569236|SUPERIORITY|||||||0.085|||||||Cochran-Mantel-Haenszel|||||||0.0850
72519885|NCT02980692|144569236|SUPERIORITY|||||||0.0234|||||||Cochran-Mantel-Haenszel|||||||0.0234
72405721|NCT01806896|144319917|SUPERIORITY_OR_OTHER||Least square mean|7.3|STANDARD_ERROR_OF_MEAN|3.57||0.04|TWO_SIDED|90.0|1.43|13.18||2-sided p-value|ANCOVA|Mixed effect model including treatment, incentive and treatment\*incentive as fixed effects; baseline, age, gender and CAG repeats as covariates.||PF-02545920 versus Placebo (Emotional Incentive-Neutral) Day 28||13.18|1.43|0.04
72405722|NCT01806896|144319917|SUPERIORITY_OR_OTHER||Least square mean|7.57|STANDARD_ERROR_OF_MEAN|3.57||0.03|TWO_SIDED|90.0|1.69|13.45||2-sided p-value|ANCOVA|Mixed effect model including treatment, incentive and treatment\*incentive as fixed effects; baseline, age, gender and CAG repeats as covariates.||PF-02545920 versus Placebo (Emotional Incentive-Positive) Day 28||13.45|1.69|0.03
72405723|NCT01806896|144319917|SUPERIORITY_OR_OTHER||Least square mean|7.28|STANDARD_ERROR_OF_MEAN|3.56||0.04|TWO_SIDED|90.0|1.41|13.15||2-sided p-value|ANCOVA|Mixed effect model including treatment, incentive and treatment\*incentive as fixed effects; baseline, age, gender and CAG repeats as covariates.||PF-02545920 versus Placebo (Emotional Incentive-Negative) Day 28||13.15|1.41|0.04
72519886|NCT02980692|144569236|SUPERIORITY|||||||0.014|||||||Cochran-Mantel-Haenszel|||||||0.0140
72519887|NCT02980692|144569236|SUPERIORITY|||||||0.0731|||||||Cochran-Mantel-Haenszel|||||||0.0731
72405724|NCT01806896|144319917|SUPERIORITY_OR_OTHER||Least square mean|0.98|STANDARD_ERROR_OF_MEAN|3.58||0.78|TWO_SIDED|90.0|-4.91|6.87||2-sided p-value|ANCOVA|Mixed effect model including treatment, incentive and treatment\*incentive as fixed effects; baseline, age, gender and CAG repeats as covariates.||PF-02545920 versus Placebo (Monetary Incentive-0.01 Euro) Day 28||6.87|-4.91|0.78
72405725|NCT01806896|144319917|SUPERIORITY_OR_OTHER||Least square mean|4.78|STANDARD_ERROR_OF_MEAN|3.58||0.18|TWO_SIDED|90.0|-1.11|10.67||2-sided p-value|ANCOVA|Mixed effect model including treatment, incentive and treatment\*incentive as fixed effects; baseline, age, gender and CAG repeats as covariates.||PF-02545920 versus Placebo (Monetary Incentive-0.1 Euro) Day 28||10.67|-1.11|0.18
72519888|NCT02980692|144569237|SUPERIORITY||Mean Difference (Net)|-12.3|STANDARD_DEVIATION|11.47|||TWO_SIDED|||||||||||||
72519889|NCT02980692|144569237|SUPERIORITY||Mean Difference (Net)|-13.7|STANDARD_DEVIATION|11.92|||TWO_SIDED|||||||||||||
72519890|NCT02980692|144569237|SUPERIORITY||Mean Difference (Net)|-16.0|STANDARD_DEVIATION|12.83|||TWO_SIDED|||||||||||||
72519891|NCT02980692|144569237|SUPERIORITY||Mean Difference (Net)|-14.0|STANDARD_DEVIATION|10.65|||TWO_SIDED|||||||||||||
72519892|NCT02980692|144569237|SUPERIORITY||Mean Difference (Net)|-13.9|STANDARD_DEVIATION|12.02|||TWO_SIDED|||||||||||||
72519893|NCT02980692|144569238|SUPERIORITY|||||||0.0111|||||||Cochran-Mantel-Haenszel|||||||0.0111
72569775|NCT02944383|144670001|SUPERIORITY||Median Difference (Net)|-47.16||||0.0428|TWO_SIDED|95.0|-119.58|-5.78||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|IDL Particles||-5.78|-119.58|0.0428
72405726|NCT01806896|144319917|SUPERIORITY_OR_OTHER||Least square mean|16.35|STANDARD_ERROR_OF_MEAN|3.58|<|0.01|TWO_SIDED|90.0|10.46|22.24||2-sided p-value|ANCOVA|Mixed effect model including treatment, incentive and treatment\*incentive as fixed effects; baseline, age, gender and CAG repeats as covariates.||PF-02545920 versus Placebo (Monetary Incentive-1 Euro) Day 28||22.24|10.46|<0.01
72519894|NCT02980692|144569238|SUPERIORITY|||||||0.0774|||||||Cochran-Mantel-Haenszel|||||||0.0774
72519895|NCT02980692|144569238|SUPERIORITY|||||||0.019|||||||Cochran-Mantel-Haenszel|||||||0.0190
72519896|NCT02980692|144569238|SUPERIORITY|||||||0.1282|||||||Cochran-Mantel-Haenszel|||||||0.1282
72519897|NCT02980692|144569239|SUPERIORITY||Mean Difference (Net)|-8.7|STANDARD_DEVIATION|6.88|||TWO_SIDED|||||||||||||
72519898|NCT02980692|144569239|SUPERIORITY||Mean Difference (Net)|-7.5|STANDARD_DEVIATION|7.07|||TWO_SIDED|||||||||||||
72519899|NCT02980692|144569239|SUPERIORITY||Mean Difference (Net)|-9.2|STANDARD_DEVIATION|7.62|||TWO_SIDED|||||||||||||
72519900|NCT02980692|144569239|SUPERIORITY||Mean Difference (Net)|-7.5|STANDARD_DEVIATION|5.78|||TWO_SIDED|||||||||||||
72519901|NCT02980692|144569239|SUPERIORITY||Mean Difference (Net)|-9.0|STANDARD_DEVIATION|8.8|||TWO_SIDED|||||||||||||
72519902|NCT02980692|144569240|SUPERIORITY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<.0001
72519903|NCT02980692|144569240|SUPERIORITY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<.0001
72519904|NCT02980692|144569240|SUPERIORITY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<.0001
72519905|NCT02980692|144569240|SUPERIORITY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<.0001
72519906|NCT02980692|144569241|SUPERIORITY||Mean Difference (Net)|-40.0|STANDARD_DEVIATION|17.38|||TWO_SIDED|||||||||||||
72519907|NCT02980692|144569241|SUPERIORITY||Mean Difference (Net)|-44.3|STANDARD_DEVIATION|19.73|||TWO_SIDED|||||||||||||
72519908|NCT02980692|144569241|SUPERIORITY||Mean Difference (Net)|-45.3|STANDARD_DEVIATION|19.84|||TWO_SIDED|||||||||||||
72519909|NCT02980692|144569241|SUPERIORITY||Mean Difference (Net)|-42.7|STANDARD_DEVIATION|19.18|||TWO_SIDED|||||||||||||
72519910|NCT02980692|144569241|SUPERIORITY||Mean Difference (Net)|-42.0|STANDARD_DEVIATION|20.41|||TWO_SIDED|||||||||||||
72519911|NCT02980692|144569242|SUPERIORITY|||||||0.0003|||||||Cochran-Mantel-Haenszel|||||||0.0003
72519912|NCT02980692|144569242|SUPERIORITY|||||||0.0012|||||||Cochran-Mantel-Haenszel|||||||0.0012
72519913|NCT02980692|144569242|SUPERIORITY|||||||0.0011|||||||Cochran-Mantel-Haenszel|||||||0.0011
72519914|NCT02980692|144569242|SUPERIORITY|||||||0.0167|||||||Cochran-Mantel-Haenszel|||||||0.0167
72519915|NCT02980692|144569243|SUPERIORITY||Mean Difference (Net)|-42.2|STANDARD_DEVIATION|22.74|||TWO_SIDED|||||||||||||
72519916|NCT02980692|144569243|SUPERIORITY||Mean Difference (Net)|-43.8|STANDARD_DEVIATION|24.01|||TWO_SIDED|||||||||||||
72519917|NCT02980692|144569243|SUPERIORITY||Mean Difference (Net)|-38.4|STANDARD_DEVIATION|27.9|||TWO_SIDED|||||||||||||
72519918|NCT02980692|144569243|SUPERIORITY||Mean Difference (Net)|-37.9|STANDARD_DEVIATION|24.65|||TWO_SIDED|||||||||||||
72519919|NCT02980692|144569243|SUPERIORITY||Mean Difference (Net)|-40.5|STANDARD_DEVIATION|28.13|||TWO_SIDED|||||||||||||
72519920|NCT02980692|144569244|SUPERIORITY|||||||0.0003|||||||Cochran-Mantel-Haenszel|||||||0.0003
72519921|NCT02980692|144569244|SUPERIORITY|||||||0.0055|||||||Cochran-Mantel-Haenszel|||||||0.0055
72519922|NCT02980692|144569244|SUPERIORITY|||||||0.0039|||||||Cochran-Mantel-Haenszel|||||||0.0039
72519923|NCT02980692|144569244|SUPERIORITY|||||||0.0487|||||||Cochran-Mantel-Haenszel|||||||0.0487
72519924|NCT02980692|144569245|SUPERIORITY||Mean Difference (Net)|-40.7|STANDARD_DEVIATION|21.59|||TWO_SIDED|||||||||||||
72519925|NCT02980692|144569245|SUPERIORITY||Mean Difference (Net)|-42.7|STANDARD_DEVIATION|25.67|||TWO_SIDED|||||||||||||
72519926|NCT02980692|144569245|SUPERIORITY||Mean Difference (Net)|-38.0|STANDARD_DEVIATION|29.26|||TWO_SIDED|||||||||||||
72519927|NCT02980692|144569245|SUPERIORITY||Mean Difference (Net)|-37.6|STANDARD_DEVIATION|26.63|||TWO_SIDED|||||||||||||
72519928|NCT02980692|144569245|SUPERIORITY||Mean Difference (Net)|-41.0|STANDARD_DEVIATION|29.83|||TWO_SIDED|||||||||||||
72519929|NCT02980692|144569246|SUPERIORITY|||||||0.0987|||||||Cochran-Mantel-Haenszel|||||||0.0987
72519930|NCT02980692|144569246|SUPERIORITY|||||||0.036|||||||Cochran-Mantel-Haenszel|||||||0.0360
72519931|NCT02980692|144569246|SUPERIORITY|||||||0.0346|||||||Cochran-Mantel-Haenszel|||||||0.0346
72519932|NCT02980692|144569246|SUPERIORITY|||||||0.4442|||||||Cochran-Mantel-Haenszel|||||||0.4442
72519933|NCT02980692|144569247|SUPERIORITY||Mean Difference (Net)|-0.4869|STANDARD_DEVIATION|0.52093|||TWO_SIDED|||||||||||||
72519934|NCT02980692|144569247|SUPERIORITY||Mean Difference (Net)|-0.543|STANDARD_DEVIATION|0.59145|||TWO_SIDED|||||||||||||
72519935|NCT02980692|144569247|SUPERIORITY||Mean Difference (Net)|-0.4857|STANDARD_DEVIATION|0.56968|||TWO_SIDED|||||||||||||
72624958|NCT02757768|144779452|SUPERIORITY||LS Mean of Difference|0.89|STANDARD_ERROR_OF_MEAN|1.28||0.486|TWO_SIDED|95.0|-1.62|3.4|||ANCOVA|||Week 12 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||3.40|-1.62|0.486
72519936|NCT02980692|144569247|SUPERIORITY||Mean Difference (Net)|-0.4583|STANDARD_DEVIATION|0.52285|||TWO_SIDED|||||||||||||
72519937|NCT02980692|144569247|SUPERIORITY||Mean Difference (Net)|-0.47|STANDARD_DEVIATION|0.54013|||TWO_SIDED|||||||||||||
72519938|NCT02980692|144569248|SUPERIORITY|||||||0.0064|||||||Cochran-Mantel-Haenszel|||||||0.0064
72519939|NCT02980692|144569248|SUPERIORITY|||||||0.0516|||||||Cochran-Mantel-Haenszel|||||||0.0516
72519940|NCT02980692|144569248|SUPERIORITY|||||||0.0114|||||||Cochran-Mantel-Haenszel|||||||0.0114
72519941|NCT02980692|144569248|SUPERIORITY|||||||0.082|||||||Cochran-Mantel-Haenszel|||||||0.0820
72519942|NCT02980692|144569249|SUPERIORITY||Mean Difference (Net)|-3.43|STANDARD_DEVIATION|12.506|||TWO_SIDED|||||||||||||
72519943|NCT02980692|144569249|SUPERIORITY||Mean Difference (Net)|-3.68|STANDARD_DEVIATION|10.77|||TWO_SIDED|||||||||||||
72519944|NCT02980692|144569249|SUPERIORITY||Mean Difference (Net)|-6.05|STANDARD_DEVIATION|19.004|||TWO_SIDED|||||||||||||
72519945|NCT02980692|144569249|SUPERIORITY||Mean Difference (Net)|-4.61|STANDARD_DEVIATION|9.508|||TWO_SIDED|||||||||||||
72519946|NCT02980692|144569249|SUPERIORITY||Mean Difference (Net)|-6.75|STANDARD_DEVIATION|19.649|||TWO_SIDED|||||||||||||
72519947|NCT02980692|144569250|SUPERIORITY|||||||0.0351|||||||Cochran-Mantel-Haenszel|||||||0.0351
72519948|NCT02980692|144569250|SUPERIORITY|||||||0.0876|||||||Cochran-Mantel-Haenszel|||||||0.0876
72519949|NCT02980692|144569250|SUPERIORITY|||||||0.0269|||||||Cochran-Mantel-Haenszel|||||||0.0269
72519950|NCT02980692|144569250|SUPERIORITY|||||||0.0185|||||||Cochran-Mantel-Haenszel|||||||0.0185
72519951|NCT02980692|144569251|SUPERIORITY||Mean Difference (Net)|-7.2|STANDARD_DEVIATION|19.58|||TWO_SIDED|||||||||||||
72519952|NCT02980692|144569251|SUPERIORITY||Mean Difference (Net)|-7.2|STANDARD_DEVIATION|15.26|||TWO_SIDED|||||||||||||
72519953|NCT02980692|144569251|SUPERIORITY||Median Difference (Net)|-8.9|STANDARD_DEVIATION|20.48|||TWO_SIDED|||||||||||||
72519954|NCT02980692|144569251|SUPERIORITY||Mean Difference (Net)|-9.7|STANDARD_DEVIATION|19.02|||TWO_SIDED|||||||||||||
72519955|NCT02980692|144569251|SUPERIORITY||Mean Difference (Net)|-9.2|STANDARD_DEVIATION|20.47|||TWO_SIDED|||||||||||||
72519956|NCT02980692|144569252|SUPERIORITY||Proportion with Adjustment of Background|1.27|STANDARD_ERROR_OF_MEAN|1.26|||TWO_SIDED|95.0|0.0|3.73||||||||3.73|0.00|
72519957|NCT02980692|144569252|SUPERIORITY||Proportion with Adjustment of Background|1.3|STANDARD_ERROR_OF_MEAN|1.29|||TWO_SIDED|95.0|0.0|3.83||||||||3.83|0.00|
72519958|NCT02980692|144569252|SUPERIORITY||Proportion with Adjustment of Background|2.56|STANDARD_ERROR_OF_MEAN|1.79|||TWO_SIDED|95.0|0.0|6.07||||||||6.07|0.00|
72519959|NCT02980692|144569252|SUPERIORITY||Proportion with Adjustment of Background|1.27|STANDARD_ERROR_OF_MEAN|1.26|||TWO_SIDED|95.0|0.0|3.73||||||||3.73|0.00|
72519960|NCT02980692|144569253|SUPERIORITY||% response rate|85.07|STANDARD_ERROR_OF_MEAN|4.35|||TWO_SIDED|95.0|76.54|93.61||||||||93.61|76.54|
72519961|NCT02980692|144569253|SUPERIORITY||% response rate|81.25|STANDARD_ERROR_OF_MEAN|4.88|||TWO_SIDED|95.0|71.69|90.81||||||||90.81|71.69|
72519962|NCT02980692|144569253|SUPERIORITY||% response rate|76.27|STANDARD_ERROR_OF_MEAN|5.54|||TWO_SIDED|95.0|65.42|87.13||||||||87.13|65.42|
72519963|NCT02980692|144569253|SUPERIORITY||% response rate|71.05|STANDARD_ERROR_OF_MEAN|5.2|||TWO_SIDED|95.0|60.86|81.25||||||||81.25|60.86|
72519964|NCT02980692|144569253|SUPERIORITY||% response rate|65.33|STANDARD_ERROR_OF_MEAN|5.5|||TWO_SIDED|95.0|54.56|76.1||||||||76.10|54.56|
72519965|NCT02980692|144569254|SUPERIORITY||% response rate|56.92|STANDARD_ERROR_OF_MEAN|6.14|||TWO_SIDED|95.0|44.88|68.96||||||||68.96|44.88|
72519966|NCT02980692|144569254|SUPERIORITY||% response rate|64.41|STANDARD_ERROR_OF_MEAN|6.23|||TWO_SIDED|95.0|52.19|76.62||||||||76.62|52.19|
72519967|NCT02980692|144569254|SUPERIORITY||% response rate|45.0|STANDARD_ERROR_OF_MEAN|6.42|||TWO_SIDED|95.0|32.41|57.59||||||||57.59|32.41|
72519968|NCT02980692|144569254|SUPERIORITY||% response rate|47.06|STANDARD_ERROR_OF_MEAN|6.05|||TWO_SIDED|95.0|35.2|58.92||||||||58.92|35.20|
72519969|NCT02980692|144569254|SUPERIORITY||% response rate|42.03|STANDARD_ERROR_OF_MEAN|5.94|||TWO_SIDED|95.0|30.38|53.68||||||||53.68|30.38|
72519970|NCT02980692|144569255|SUPERIORITY|||||||0.7081|||||||Cochran-Mantel-Haenszel|||||||0.7081
72519971|NCT02980692|144569255|SUPERIORITY|||||||0.9244|||||||Cochran-Mantel-Haenszel|||||||0.9244
72519972|NCT02980692|144569255|SUPERIORITY|||||||0.5365|||||||Cochran-Mantel-Haenszel|||||||0.5365
72519973|NCT02980692|144569255|SUPERIORITY|||||||0.2925|||||||Cochran-Mantel-Haenszel|||||||0.2925
72519974|NCT02980692|144569256|SUPERIORITY||Mean Difference (Net)|-14.453|STANDARD_DEVIATION|31.9358|||TWO_SIDED|||||||||||||
72519975|NCT02980692|144569256|SUPERIORITY||Mean Difference (Net)|-18.883|STANDARD_DEVIATION|57.1147|||TWO_SIDED|||||||||||||
72519976|NCT02980692|144569256|SUPERIORITY||Mean Difference (Net)|-27.084|STANDARD_DEVIATION|76.2272|||TWO_SIDED|||||||||||||
72519977|NCT02980692|144569256|SUPERIORITY||Mean Difference (Net)|-26.173|STANDARD_DEVIATION|87.5367|||TWO_SIDED|||||||||||||
72405727|NCT00640510|144319936|SUPERIORITY_OR_OTHER|||||||0.94||95.0|||||t-test, 2 sided|||A sample size of at least 15 patients per group was necessary to verify that the decrease in PANSS-EC total score was significantly greater in the IM olanzapine group than the placebo group using Student's t-test with a power of 90% at a two-sided significance level of 5%.||||0.940
72405728|NCT00640510|144319937|SUPERIORITY_OR_OTHER|||||||1||95.0||||P-value for Change from Baseline to 15 minutes. Change = Timepoint minus Baseline.|t-test, 2 sided|||||||1.000
72624959|NCT02757768|144779452|SUPERIORITY||LS Mean of Difference|-0.05|STANDARD_ERROR_OF_MEAN|1.26||0.968|TWO_SIDED|95.0|-2.52|2.42|||ANCOVA|||EoT Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||2.42|-2.52|0.968
72519978|NCT02980692|144569256|SUPERIORITY||Mean Difference (Net)|-50.399|STANDARD_DEVIATION|141.677|||TWO_SIDED|||||||||||||
72519979|NCT02980692|144569257|SUPERIORITY|||||||0.0203|||||||Cochran-Mantel-Haenszel|||||||0.0203
72519980|NCT02980692|144569257|SUPERIORITY|||||||0.5194|||||||Cochran-Mantel-Haenszel|||||||0.5194
72519981|NCT02980692|144569257|SUPERIORITY|||||||0.0599|||||||Cochran-Mantel-Haenszel|||||||0.0599
72519982|NCT02980692|144569257|SUPERIORITY|||||||0.122|||||||Cochran-Mantel-Haenszel|||||||0.1220
72519983|NCT02980692|144569258|SUPERIORITY||Mean Difference (Net)|-1.3|STANDARD_DEVIATION|1.86|||TWO_SIDED|||||||||||||
72519984|NCT02980692|144569258|SUPERIORITY||Mean Difference (Net)|-1.0|STANDARD_DEVIATION|1.56|||TWO_SIDED|||||||||||||
72519985|NCT02980692|144569258|SUPERIORITY||Mean Difference (Net)|-1.7|STANDARD_DEVIATION|2.08|||TWO_SIDED|||||||||||||
72624960|NCT02757768|144779453|SUPERIORITY||LS Mean of Difference|-1.89|STANDARD_ERROR_OF_MEAN|1.36||0.165|TWO_SIDED|95.0|-4.56|0.78|||ANCOVA|||Week 4 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||0.78|-4.56|0.165
72405729|NCT00640510|144319937|SUPERIORITY_OR_OTHER|||||||0.62||95.0||||P-value for Change from Baseline to 30 minutes. Change = Timepoint minus baseline.|t-test, 2 sided|||||||0.620
72405730|NCT00640510|144319937|SUPERIORITY_OR_OTHER|||||||0.784||95.0||||P-value for Change from Baseline to 60 minutes. Change = Timepoint minus baseline.|t-test, 2 sided|||||||0.784
72405731|NCT00640510|144319937|SUPERIORITY_OR_OTHER|||||||0.756||95.0||||P-value for Change from Baseline to 90 minutes. Change = Timepoint minus baseline.|t-test, 2 sided|||||||0.756
72405732|NCT00640510|144319938|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|||||||1.000
72405733|NCT00640510|144319939|SUPERIORITY_OR_OTHER|||||||1||95.0||||P-value for 30 Minutes.|Fisher Exact|||||||1.000
72405734|NCT00640510|144319939|SUPERIORITY_OR_OTHER|||||||1||95.0||||P-value for 60 Minutes.|Fisher Exact|||||||1.000
72519986|NCT02980692|144569258|SUPERIORITY||Mean Difference (Net)|-1.2|STANDARD_DEVIATION|1.75|||TWO_SIDED|||||||||||||
72519987|NCT02980692|144569258|SUPERIORITY||Mean Difference (Net)|-1.2|STANDARD_DEVIATION|1.82|||TWO_SIDED|||||||||||||
72519988|NCT00294684|144569259|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|1.14||||0.43|TWO_SIDED|95.0|0.83|1.57|||Log binomial|||RR greater than one indicates benefit of steriods and a P value of treatment success from a log-binomial model with these covariates: Treatment group, age a HPE, BASM as fixed effects, and site as a random effect.||1.57|0.83|0.43
72519989|NCT00294684|144569260|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.0||||0.99|TWO_SIDED|95.0|0.6|1.8|||Regression, Cox|||||1.8|0.6|0.99
72519990|NCT00294684|144569261|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-1.6||||0.0973|TWO_SIDED|95.0|-3.49|0.3|||Mixed Models Analysis|||LS Mean difference reported as steroid minus placebo (negative values mean larger average values of total bilirubin in placebo).||0.3|-3.49|0.0973
72519991|NCT00294684|144569262|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-2.3||||0.0552|TWO_SIDED|95.0|-4.65|0.05|||Mixed Models Analysis|||LS Mean difference of steroid minus placebo (negative values indicate larger average values of bilirubin in placebo)||0.05|-4.65|0.0552
72519992|NCT00294684|144569263|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.39||||0.6607||95.0|-2.16|1.38|||Mixed Models Analysis|||LS Mean difference of steroid minus placebo (negative values indicate larger average bilirubin in placebo)||1.38|-2.16|0.6607
72519993|NCT00294684|144569264|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1603|||||||Mixed Models Analysis|||||||0.1603
72519994|NCT00294684|144569265|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2801|||||||Mixed Models Analysis|||||||0.2801
72519995|NCT00294684|144569266|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|1.4||||0.41|TWO_SIDED|95.0|0.62|3.14|||Log Binomial|||||3.14|0.62|0.41
72519996|NCT00294684|144569267|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.3||||0.29|TWO_SIDED|95.0|0.03|2.92|||Log Binomial|||||2.92|0.03|0.29
72519997|NCT03238352|144569304|OTHER||Difference of Least Square mean|-1.22|STANDARD_ERROR_OF_MEAN|0.22|<|0.0001|TWO_SIDED|95.0|-1.657|-0.782|||ANCOVA|From ANCOVA model with treatment as factor and baseline Schiff score as covariate.|Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|Test Product versus Negative Control at Week 8 is a primary endpoint comparison.||-0.782|-1.657|<0.0001
72519998|NCT03238352|144569304|OTHER||Difference of Least Square mean|-1.28|STANDARD_ERROR_OF_MEAN|0.213|<|0.0001|TWO_SIDED|95.0|-1.705|-0.858|||ANCOVA|From ANCOVA model with treatment as factor and baseline Schiff score as covariate.|Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|||-0.858|-1.705|<.0001
72519999|NCT03238352|144569304|OTHER||Difference of Least Square mean|-1.25|STANDARD_ERROR_OF_MEAN|0.176|<|0.0001|TWO_SIDED|95.0|-1.6|-0.901|||ANCOVA|From ANCOVA model with treatment as factor and baseline Schiff score as covariate.|Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|Test Product versus Combined Control (Placebo and Negative Control) group was obtained by using estimates statement in the ANCOVA model.||-0.901|-1.600|<0.0001
72520000|NCT03238352|144569305|OTHER||Diference of Least Square mean|37.46|STANDARD_ERROR_OF_MEAN|7.306|<|0.0004|TWO_SIDED|95.0|22.916|51.995||P-value from Van Elteren test|ANCOVA|From ANCOVA model with treatment and baseline Schiff stratification as factors and baseline tactile threshold as a covariate.|Difference is the first named treatment minus second named treatment such that a positive difference favors the first named treatment.|||51.995|22.916|<0.0004
72405735|NCT00640510|144319939|SUPERIORITY_OR_OTHER|||||||1||95.0||||P-value for 90 Minutes.|Fisher Exact|||||||1.000
72405736|NCT00640510|144319939|SUPERIORITY_OR_OTHER|||||||1||95.0||||P-value for 2 Hours.|Fisher Exact|||||||1.000
72405737|NCT01956110|144319956|NON_INFERIORITY|The lower bound of the 95% CI was well above the pre-specified non-inferiority limit of -8.0%. Thus, non-inferiority of FE 999049 to GONAL-F with regard to ongoing pregnancy rate was demonstrated.|Treatment difference|-0.9|||||TWO_SIDED|95.0|-5.9|4.1||||||The pre-specified non-inferiority margin was -8.0% (absolute). Non-inferiority was evaluated based on a two-sided 95% confidence interval (CI) derived based on the asymptotic normal distribution. The treatment comparison was adjusted for age (\<35, 35-37 and 38-40 years) by using the Mantel-Haenszel method to combine results across age-strata.||4.1|-5.9|
72405738|NCT01956110|144319957|NON_INFERIORITY|The lower bound of the 95% CI was well above the pre-specified non-inferiority limit of -8.0%. Thus, non-inferiority of FE 999049 to GONAL-F with regard to ongoing implantation rate was demonstrated.|Treatment difference|-0.6|||||TWO_SIDED|95.0|-6.1|4.8||||||The pre-specified non-inferiority margin was -8.0% (absolute). Non-inferiority was evaluated based on a two-sided 95% CI derived based on the asymptotic normal distribution. The treatment comparison was adjusted for age (\<35, 35-37 and 38-40 years) by using the Mantel-Haenszel method to combine results across age-strata.||4.8|-6.1|
72405739|NCT01956110|144319958|NON_INFERIORITY|The lower bound of the 95% CI was well above -8.0% (pre-specified non-inferiority limit for the co-primary endpoints). Thus, the result was supportive of the co-primary endpoint analyses.|Treatment difference|-1.6|||||TWO_SIDED|95.0|-6.7|3.4||||||Treatment groups were compared using a two-sided 95% CI derived based on the asymptotic normal distribution. The treatment comparison was adjusted for age (\<35, 35-37 and 38-40 years) by using the Mantel-Haenszel method to combine results across age-strata.||3.4|-6.7|
72405740|NCT01956110|144319959|NON_INFERIORITY|The lower bound of the 95% CI was well above -8.0% (pre-specified non-inferiority limit for the co-primary endpoints). Thus, the result was supportive of the co-primary endpoint analyses.|Treatment difference|-1.4|||||TWO_SIDED|95.0|-7.0|4.2||||||Treatment groups were compared using a two-sided 95% CI derived based on the asymptotic normal distribution. The treatment comparison was adjusted for age (\<35, 35-37 and 38-40 years) by using the Mantel-Haenszel method to combine results across age-strata.||4.2|-7.0|
72405741|NCT01956110|144319960|OTHER|A logistic regression model was fitted to the data including AMH, log(AMH)\^2, treatment group and interactions between treatment group and AMH and treatment group and log(AMH)\^2 in the linear predictor. A second logistic regression model (nested within the first model) was fitted including AMH and log(AMH)\^2 in the linear predictor.|||||=|0.001||||||Inclusion of treatment provides a better fit to the data.|Likelihood ratio test|Likelihood ratio test comparing the reduced model including only AMH to the full model including AMH, treatment group and interactions.||Treatment comparison: \<4 or \>=15 oocytes retrieved||||=0.001
72405742|NCT01956110|144319960|OTHER|A logistic regression model was fitted to the data including AMH, log(AMH)2, treatment group and interactions between treatment group and AMH and treatment group and log(AMH)\^2 in the linear predictor. A second logistic regression model (nested within the first model) was fitted including AMH and log(AMH)\^2 in the linear predictor.|||||=|0.002||||||Inclusion of treatment provides a better fit to the data.|Likelihood ratio test|Likelihood ratio test comparing the reduced model including only AMH to the full model including AMH, treatment group and interactions.||Treatment comparison: \<4 or \>=20 oocytes retrieved||||=0.002
72405743|NCT01956110|144319961|OTHER|Nested logistic regression models were compared using the likelihood ratio test. The full logistic regression model included treatment as factor, log(AMH) as covariate and the interaction term. The nested model did not include treatment and the interaction term.|||||=|0.291||||||Inclusion of treatment does not provide a better fit to the data.|Likelihood ratio test|Likelihood ratio test comparing the reduced model including only AMH to the full model including AMH, treatment group and interactions.||Treatment comparison: Early OHSS (any grade)||||=0.291
72405744|NCT01956110|144319961|OTHER|Nested logistic regression models were compared using the likelihood ratio test. The full logistic regression model included treatment as factor, log(AMH) as covariate and the interaction term. The nested model did not include treatment and the interaction term.|||||=|0.644||||||Inclusion of treatment does not provide a better fit to the data.|Likelihood ratio test|Likelihood ratio test comparing the reduced model including only AMH to the full model including AMH, treatment group and interactions.||Treatment comparison: Early OHSS (moderate/severe)||||=0.644
72405745|NCT01956110|144319961|OTHER|Nested logistic regression models were compared using the likelihood ratio test. The full logistic regression model included treatment as factor, log(AMH) as covariate and the interaction term. The nested model did not include treatment and the interaction term.|||||=|0.005||||||Inclusion of treatment does not provide a better fit to the data.|Likelihood ratio test|Likelihood ratio test comparing the reduced model including only AMH to the full model including AMH, treatment group and interactions.||Treatment comparison: Preventive interventions||||=0.005
72405746|NCT01956110|144319961|OTHER|Nested logistic regression models were compared using the likelihood ratio test. The full logistic regression model included treatment as factor, log(AMH) as covariate and the interaction term. The nested model did not include treatment and the interaction term.|||||=|0.046||||||Inclusion of treatment does not provide a better fit to the data.|Likelihood ratio test|Likelihood ratio test comparing the reduced model including only AMH to the full model including AMH, treatment group and interactions.||Treatment comparison: Early OHSS (any grade) and/or preventive interventions||||=0.046
72405747|NCT01956110|144319961|OTHER|Nested logistic regression models were compared using the likelihood ratio test. The full logistic regression model included treatment as factor, log(AMH) as covariate and the interaction term. The nested model did not include treatment and the interaction term.|||||=|0.019||||||Inclusion of treatment does not provide a better fit to the data.|Likelihood ratio test|Likelihood ratio test comparing the reduced model including only AMH to the full model including AMH, treatment group and interactions.||Treatment comparison: Early OHSS (moderate/severe) and/or preventive interventions||||=0.019
72405748|NCT01956110|144319962|EQUIVALENCE|Treatment groups were compared using a logistic regression model with treatment and age (\<35, 35- 37, and 38-40 years) as factors.|Odds Ratio (OR)|1.38|||=|0.302|TWO_SIDED|95.0|0.74|2.57||P-value corresponds to test for treatment difference.|Likelihood ratio test|||Treatment comparison: Cycle cancelled due to poor response||2.57|0.74|=0.302
72520001|NCT03238352|144569305|OTHER||Diference of Least Square mean|49.88|STANDARD_ERROR_OF_MEAN|7.079|<|0.0001|TWO_SIDED|95.0|35.791|63.966||P-value from Van Elteren test|ANCOVA|From ANCOVA model with treatment and baseline Schiff stratification as factors and baseline tactile threshold as a covariate.|Difference is the first named treatment minus second named treatment such that a positive difference favors the first named treatment.|||63.966|35.791|<.0001
72520002|NCT03238352|144569305|OTHER||Diference of Least Square mean|43.67|STANDARD_ERROR_OF_MEAN|5.862|<|0.0001|TWO_SIDED|95.0|32.001|55.334||P-value from Van Elteren test.|ANCOVA|From ANCOVA model with treatment and baseline Schiff stratification as factors and baseline tactile threshold as a covariate.|Difference is the first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Test Product versus Combined Control (Placebo and Negative Control) group is obtained by using estimates statement in the ANCOVA model||55.334|32.001|<.0001
72520003|NCT04153929|144569324|OTHER|Mixed Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod. MMRM with fixed, categorical factors of treatment at each visit, and continuous factors of baseline at each visit, using visit (Week 5, 8, 12, 16 and 17) as repeated measures, subject as random effect, unstructured covariance matrix to model within subject measurements.|||||<|0.0001|||||||MCP-Mod linear model fit|Model assumption: The maximum effect is achieved at 3.6 mg dose.||A flat vs. non-flat dose-response relationship across the 6 doses of BI 456906 and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, exponential, Emax 1, Emax 2 and Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.025). For the twice weekly dosing schemes the total dose per week was considered for the MCP-Mod analysis.||||<0.0001
72520004|NCT04153929|144569324|OTHER|Mixed Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod. MMRM with fixed, categorical factors of treatment at each visit, and continuous factors of baseline at each visit, using visit (Week 5, 8, 12, 16 and 17) as repeated measures, subject as random effect, unstructured covariance matrix to model within subject measurements.|||||<|0.0001|||||||MCP-Mod Exponential model fit|Model assumption: 90% of the maximum effect is achieved at 3.6 mg dose.||A flat vs. non-flat dose-response relationship across the 6 doses of BI 456906 and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, exponential, Emax 1, Emax 2 and Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.025). For the twice weekly dosing schemes the total dose per week was considered for the MCP-Mod analysis.||||<0.0001
72520005|NCT04153929|144569324|OTHER|Mixed Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod. MMRM with fixed, categorical factors of treatment at each visit, and continuous factors of baseline at each visit, using visit (Week 5, 8, 12, 16 and 17) as repeated measures, subject as random effect, unstructured covariance matrix to model within subject measurements.|||||<|0.0001|||||||MCP-Mod Emax 1 model fit|Model assumption: 90% of the maximum effect is achieved at 3.6 mg dose.||A flat vs. non-flat dose-response relationship across the 6 doses of BI 456906 and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, exponential, Emax 1, Emax 2 and Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.025). For the twice weekly dosing schemes the total dose per week was considered for the MCP-Mod analysis.||||<0.0001
72520006|NCT04153929|144569324|OTHER|Mixed Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod. MMRM with fixed, categorical factors of treatment at each visit, and continuous factors of baseline at each visit, using visit (Week 5, 8, 12, 16 and 17) as repeated measures, subject as random effect, unstructured covariance matrix to model within subject measurements.|||||<|0.0001|||||||MCP-Mod Emax 2 model fit|Model assumption: 70% of the maximum effect is achieved at 3.6 mg dose.||A flat vs. non-flat dose-response relationship across the 6 doses of BI 456906 and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, exponential, Emax 1, Emax 2 and Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.025). For the twice weekly dosing schemes the total dose per week was considered for the MCP-Mod analysis.||||<0.0001
72520007|NCT04153929|144569324|OTHER|Mixed Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod. MMRM with fixed, categorical factors of treatment at each visit, and continuous factors of baseline at each visit, using visit (Week 5, 8, 12, 16 and 17) as repeated measures, subject as random effect, unstructured covariance matrix to model within subject measurements.|||||<|0.0001|||||||MCP-Mod Sigmoid Emax model fit|Model assumption: 50% of the maximum effect is achieved at 1.8 mg and 90% of the maximum effect is achieved at 3.6 mg dose.||A flat vs. non-flat dose-response relationship across the 6 doses of BI 456906 and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, exponential, Emax 1, Emax 2 and Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.025). For the twice weekly dosing schemes the total dose per week was considered for the MCP-Mod analysis.||||<0.0001
72520008|NCT04153929|144569324|OTHER|No formal hypotheses were tested.|Difference of adjusted means|-0.76|||<|0.0001|TWO_SIDED|95.0|-1.06|-0.46||P-value is considered nominal.|Mixed Model for Repeated Measures|Kenward-Roger was used to estimate denominator degrees of freedom.|Difference was calculated as BI 456906 0.3 mg - Placebo at Week 17.|Mixed Model Repeated Measures (MMRM) with fixed, categorical factors of treatment at each visit, and continuous factors of baseline at each visit, using visit (Week 5, 8, 12, 16 and 17) as repeated measures, subject as random effect, unstructured covariance matrix to model within subject measurements.||-0.46|-1.06|<0.0001
72569776|NCT02944383|144670001|SUPERIORITY||Median Difference (Net)|-26.13||||0.1836|TWO_SIDED|95.0|-121.44|19.48||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|IDL Particles||19.48|-121.44|0.1836
72569777|NCT02944383|144670002|SUPERIORITY|||||||0.1251||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||VLDL \& Chylomicron Particles||||0.1251
72405749|NCT01956110|144319962|EQUIVALENCE|Treatment groups were compared using a logistic regression model with treatment and age (\<35, 35-37, and 38-40 years) as factors.|Odds Ratio (OR)|0.42||||0.019|TWO_SIDED|95.0|0.2|0.9||P-value corresponds to test for treatment difference.|Likelihood ratio test|||Treatment comparison:Triggering with GnRH agonist||0.9|0.2|0.019
72405750|NCT01956110|144319963|EQUIVALENCE|Treatment groups were compared using the van Elteren test adjusted for age (\<35, 35-37, and 38-40 years).|||||=|0.692|||||||van Elteren|||Treatment comparison: Number of oocytes retrieved||||=0.692
72520009|NCT04153929|144569324|OTHER|No formal hypotheses were tested.|Difference of adjusted means|-1.31|||<|0.0001|TWO_SIDED|95.0|-1.6|-1.01||P-value is considered nominal.|Mixed Model for Repeated Measures|Kenward-Roger was used to estimate denominator degrees of freedom.|Difference was calculated as BI 456906 0.9 mg - Placebo at Week 17.|Mixed Model Repeated Measures (MMRM) with fixed, categorical factors of treatment at each visit, and continuous factors of baseline at each visit, using visit (Week 5, 8, 12, 16 and 17) as repeated measures, subject as random effect, unstructured covariance matrix to model within subject measurements.||-1.01|-1.60|<0.0001
72520010|NCT04153929|144569324|OTHER|No formal hypotheses were tested.|Difference of adjusted means|-1.56|||<|0.0001|TWO_SIDED|95.0|-1.87|-1.26||P-value is considered nominal.|Mixed Model for Repeated Measures|Kenward-Roger was used to estimate denominator degrees of freedom.|Difference was calculated as BI 456906 1.8 mg - Placebo at Week 17.|Mixed Model Repeated Measures (MMRM) with fixed, categorical factors of treatment at each visit, and continuous factors of baseline at each visit, using visit (Week 5, 8, 12, 16 and 17) as repeated measures, subject as random effect, unstructured covariance matrix to model within subject measurements.||-1.26|-1.87|<0.0001
72624961|NCT02757768|144779453|SUPERIORITY||LS Mean of Difference|0.76|STANDARD_ERROR_OF_MEAN|1.41||0.592|TWO_SIDED|95.0|-2.02|3.54|||ANCOVA|||Week 8 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||3.54|-2.02|0.592
72405751|NCT01956110|144319964|OTHER|"A logistic regression model was fitted to the data including AMH, log(AMH)\^2, treatment group and interactions between treatment group and AMH and treatment group and log(AMH)\^2 in the linear predictor.~A second logistic regression model (nested within the first model) was fitted including AMH and log(AMH)\^2 in the linear predictor."|||||=|0.019||||||Inclusion of treatment provides a better fit to the data|Likelihood ratio test|Likelihood ratio test comparing the reduced model including only AMH to the full model including AMH, treatment group and interactions.||The relation between ovarian response potential (AMH at screening) and probability of achieving the targeted response was modelled using logistic regression models.||||=0.019
72405752|NCT01956110|144319965|EQUIVALENCE|Treatment groups were compared using the van Elteren test adjusted for age (\<35, 35-37, and 38-40 years).|||||=|0.909|||||||van Elteren|||Treatment comparison: Number of metaphase II oocytes||||=0.909
72520011|NCT04153929|144569324|OTHER|No formal hypotheses were tested.|Difference of adjusted means|-1.41|||<|0.0001|TWO_SIDED|95.0|-1.72|-1.1||P-value is considered nominal.|Mixed Model for Repeated Measures (MMRM)|Kenward-Roger was used to estimate denominator degrees of freedom.|Difference was calculated as BI 456906 2.7 mg - Placebo at Week 17.|Mixed Model Repeated Measures (MMRM) with fixed, categorical factors of treatment at each visit, and continuous factors of baseline at each visit, using visit (Week 5, 8, 12, 16 and 17) as repeated measures, subject as random effect, unstructured covariance matrix to model within subject measurements.||-1.10|-1.72|<0.0001
72520012|NCT04153929|144569324|OTHER|No formal hypotheses were tested.|Difference of adjusted means|-1.49|||<|0.0001|TWO_SIDED|95.0|-1.78|-1.19||P-value is considered nominal.|Mixed Model for Repeated Measures (MMRM)|Kenward-Roger was used to estimate denominator degrees of freedom.|"Difference was calculated as BI 456906 1.2 twice weekly (2.4) mg - Placebo at Week 17."|Mixed Model Repeated Measures (MMRM) with fixed, categorical factors of treatment at each visit, and continuous factors of baseline at each visit, using visit (Week 5, 8, 12, 16 and 17) as repeated measures, subject as random effect, unstructured covariance matrix to model within subject measurements.||-1.19|-1.78|<0.0001
72520013|NCT04153929|144569324|OTHER|No formal hypotheses were tested.|Difference of adjusted means|-1.53|||<|0.0001|TWO_SIDED|95.0|-1.84|-1.22||P-value is considered nominal.|Mixed Model for Repeated Measures (MMRM)|Kenward-Roger was used to estimate denominator degrees of freedom.|"Difference was calculated as BI 456906 1.8 twice weekly (3.6) mg - Placebo at Week 17."|Mixed Model Repeated Measures (MMRM) with fixed, categorical factors of treatment at each visit, and continuous factors of baseline at each visit, using visit (Week 5, 8, 12, 16 and 17) as repeated measures, subject as random effect, unstructured covariance matrix to model within subject measurements.||-1.22|-1.84|<0.0001
72520014|NCT04153929|144569325|OTHER|"Mixed Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod.~MMRM with fixed, categorical factors of treatment at each visit, and continuous factors of baseline at each visit, using visit (Week 2, 3, 4, 5, 6, 7, 8, 12, 16 and 17 ) as repeated measures, subject as random effect, unstructured covariance matrix to model within subject measurements."|||||<|0.0001|||||||MCP-Mod linear model fit|Model assumption: The maximum effect is achieved at 3.6 mg dose.||A flat vs. non-flat dose-response relationship across the 6 doses of BI 456906 and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, exponential, Emax 1, Emax 2 and Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.025). For the twice weekly dosing schemes the total dose per week was considered for the MCP-Mod analysis.||||<0.0001
72520015|NCT04153929|144569325|OTHER|"Mixed Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod.~MMRM with fixed, categorical factors of treatment at each visit, and continuous factors of baseline at each visit, using visit (Week 2, 3, 4, 5, 6, 7, 8, 12, 16 and 17 ) as repeated measures, subject as random effect, unstructured covariance matrix to model within subject measurements."|||||<|0.0001|||||||MCP-Mod exponential model fit|Model assumption: 90% of the maximum effect is achieved at 3.6 mg dose.||A flat vs. non-flat dose-response relationship across the 6 doses of BI 456906 and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, exponential, Emax 1, Emax 2 and Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.025). For the twice weekly dosing schemes the total dose per week was considered for the MCP-Mod analysis.||||<0.0001
72520016|NCT04153929|144569325|OTHER|"Mixed Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod.~MMRM with fixed, categorical factors of treatment at each visit, and continuous factors of baseline at each visit, using visit (Week 2, 3, 4, 5, 6, 7, 8, 12, 16 and 17 ) as repeated measures, subject as random effect, unstructured covariance matrix to model within subject measurements."|||||<|0.0001|||||||MCP-Mod Emax 1 model fit|Model assumption: 90% of the maximum effect is achieved at 3.6 mg dose.||A flat vs. non-flat dose-response relationship across the 6 doses of BI 456906 and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, exponential, Emax 1, Emax 2 and Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.025). For the twice weekly dosing schemes the total dose per week was considered for the MCP-Mod analysis.||||<0.0001
72520017|NCT04153929|144569325|OTHER|"Mixed Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod.~MMRM with fixed, categorical factors of treatment at each visit, and continuous factors of baseline at each visit, using visit (Week 2, 3, 4, 5, 6, 7, 8, 12, 16 and 17 ) as repeated measures, subject as random effect, unstructured covariance matrix to model within subject measurements."|||||<|0.0001|||||||MCP-Mod Emax 2 model fit|Model assumption: 70% of the maximum effect is achieved at 3.6 mg dose.||A flat vs. non-flat dose-response relationship across the 6 doses of BI 456906 and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, exponential, Emax 1, Emax 2 and Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.025). For the twice weekly dosing schemes the total dose per week was considered for the MCP-Mod analysis.||||<0.0001
72520018|NCT04153929|144569325|OTHER|"Mixed Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod.~MMRM with fixed, categorical factors of treatment at each visit, and continuous factors of baseline at each visit, using visit (Week 2, 3, 4, 5, 6, 7, 8, 12, 16 and 17 ) as repeated measures, subject as random effect, unstructured covariance matrix to model within subject measurements."|||||<|0.0001|||||||MCP-Mod Sigmoid Emax model fit|Model assumption: 50% of the maximum effect is achieved at 1.8 mg and 90% of the maximum effect is achieved at 3.6 mg dose.||A flat vs. non-flat dose-response relationship across the 6 doses of BI 456906 and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, exponential, Emax 1, Emax 2 and Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.025). For the twice weekly dosing schemes the total dose per week was considered for the MCP-Mod analysis.||||<0.0001
72520019|NCT04153929|144569325|OTHER|No formal hypotheses were tested.|Difference of adjusted means|-1.11||||0.2228|TWO_SIDED|95.0|-2.9|0.68||P-value is considered nominal.|Mixed Model for Repeated Measures (MMRM)|Kenward-Roger was used to estimate denominator degrees of freedom.|"Difference was calculated as BI 456906 0.3 mg - Placebo at Week 17."|Mixed Model Repeated Measures (MMRM) with fixed, categorical factors of treatment at each visit, and continuous factors of baseline at each visit, using visit (Week 2, 3, 4, 5, 6, 7, 8, 12, 16 and 17 ) as repeated measures, subject as random effect, unstructured covariance matrix to model within subject measurements.||0.68|-2.90|0.2228
72520020|NCT04153929|144569325|OTHER|No formal hypotheses were tested.|Difference of adjusted means|-3.79|||<|0.0001|TWO_SIDED|95.0|-5.56|-2.01||P-value is considered nominal.|Mixed Model for Repeated Measures (MMRM)|Kenward-Roger was used to estimate denominator degrees of freedom.|"Difference was calculated as BI 456906 0.9 mg - Placebo at Week 17."|Mixed Model Repeated Measures (MMRM) with fixed, categorical factors of treatment at each visit, and continuous factors of baseline at each visit, using visit (Week 2, 3, 4, 5, 6, 7, 8, 12, 16 and 17 ) as repeated measures, subject as random effect, unstructured covariance matrix to model within subject measurements.||-2.01|-5.56|<0.0001
72520021|NCT04153929|144569325|OTHER|No formal hypotheses were tested.|Difference of adjusted means|-5.61|||<|0.0001|TWO_SIDED|95.0|-7.41|-3.81||P-value is considered nominal.|Mixed Model for Repeated Measures (MMRM)|Kenward-Roger was used to estimate denominator degrees of freedom.|"Difference was calculated as BI 456906 1.8 mg - Placebo at Week 17."|Mixed Model Repeated Measures (MMRM) with fixed, categorical factors of treatment at each visit, and continuous factors of baseline at each visit, using visit (Week 2, 3, 4, 5, 6, 7, 8, 12, 16 and 17 ) as repeated measures, subject as random effect, unstructured covariance matrix to model within subject measurements.||-3.81|-7.41|<0.0001
72405753|NCT01956110|144319966|EQUIVALENCE|Treatment groups were compared using the van Elteren test adjusted for age (\<35, 35-37, and 38-40 years).||||||0.53|||||||van Elteren|||Treatment comparison: Fertilisation rate||||0.53
72405754|NCT01956110|144319967|EQUIVALENCE|Treatment groups were compared using the van Elteren test adjusted for age (\<35, 35-37, and 38-40 years).|||||=|0.59|||||||van Elteren|||Treatment comparison: Number of embryos||||=0.59
72569778|NCT02944383|144670002|SUPERIORITY|||||||0.9047||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||VLDL \& Chylomicron Particles||||0.9047
72569779|NCT02944383|144670002|SUPERIORITY|||||||0.0788||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||LDL Particles||||0.0788
72405755|NCT01956110|144319967|EQUIVALENCE|Treatment groups were compared using the van Elteren test adjusted for age (\<35, 35-37, and 38-40 years).|||||=|0.414|||||||van Elteren|||Treatment comparison: Good quality embryos||||=0.414
72405756|NCT01956110|144319968|EQUIVALENCE|Treatment groups were compared using the van Elteren test adjusted for age (\<35, 35-37, and 38-40 years).|||||=|0.344|||||||van Elteren|||Treatment comparison: Number of blastocysts||||= 0.344
72405757|NCT01956110|144319968|EQUIVALENCE|Treatment groups were compared using the van Elteren test adjusted for age (\<35, 35-37, and 38-40 years).|||||=|0.58|||||||van Elteren|||Treatment comparison: Good-quality blastocysts||||= 0.58
72405758|NCT01956110|144319969|EQUIVALENCE|Treatment groups were compared using the van Elteren test adjusted for age (\<35, 35-37, and 38-40 years).|||||<|0.001|||||||van Elteren|||Treatment comparison: Total gonadotropin dose||||<0.001
72405759|NCT01956110|144319970|EQUIVALENCE|Treatment groups were compared using the van Elteren test adjusted for age (\<35, 35-37, and 38-40 years).|||||=|0.062|||||||van Elteren|||Treatment comparison: Number of stimulation days||||=0.062
72520022|NCT04153929|144569325|OTHER|No formal hypotheses were tested.|Difference of adjusted means|-6.25|||<|0.0001|TWO_SIDED|95.0|-8.12|-4.38||P-value is considered nominal.|Mixed Model for Repeated Measures (MMRM)|Kenward-Roger was used to estimate denominator degrees of freedom.|"Difference was calculated as BI 456906 2.7 mg - Placebo at Week 17."|Mixed Model Repeated Measures (MMRM) with fixed, categorical factors of treatment at each visit, and continuous factors of baseline at each visit, using visit (Week 2, 3, 4, 5, 6, 7, 8, 12, 16 and 17 ) as repeated measures, subject as random effect, unstructured covariance matrix to model within subject measurements.||-4.38|-8.12|<0.0001
72520023|NCT04153929|144569325|OTHER|No formal hypotheses were tested.|Difference of adjusted means|-6.25|||<|0.0001|TWO_SIDED|95.0|-8.02|-4.47||P-value is considered nominal.|Mixed Model for Repeated Measures (MMRM)|Kenward-Roger was used to estimate denominator degrees of freedom.|"Difference was calculated as BI 456906 1.2 twice weekly (2.4) mg - Placebo at Week 17."|Mixed Model Repeated Measures (MMRM) with fixed, categorical factors of treatment at each visit, and continuous factors of baseline at each visit, using visit (Week 2, 3, 4, 5, 6, 7, 8, 12, 16 and 17 ) as repeated measures, subject as random effect, unstructured covariance matrix to model within subject measurements.||-4.47|-8.02|<0.0001
72520024|NCT04153929|144569325|OTHER|No formal hypotheses were tested.|Difference of adjusted means|-7.68|||<|0.0001|TWO_SIDED|95.0|-9.52|-5.83||P-value is considered nominal.|Mixed Model for Repeated Measures (MMRM)|Kenward-Roger was used to estimate denominator degrees of freedom.|"Difference was calculated as BI 456906 1.8 twice weekly (3.6) mg - Placebo at Week 17."|Mixed Model Repeated Measures (MMRM) with fixed, categorical factors of treatment at each visit, and continuous factors of baseline at each visit, using visit (Week 2, 3, 4, 5, 6, 7, 8, 12, 16 and 17 ) as repeated measures, subject as random effect, unstructured covariance matrix to model within subject measurements.||-5.83|-9.52|<0.0001
72520025|NCT04153929|144569326|OTHER|No formal hypotheses were tested.|Difference of adjusted means|-0.66||||0.4439|TWO_SIDED|95.0|-2.34|1.03||P-value is considered nominal.|Mixed Model for Repeated Measures (MMRM)|Kenward-Roger was used to estimate denominator degrees of freedom.|"Difference was calculated as BI 456906 0.3 mg - Placebo at Week 17."|Mixed Model Repeated Measures (MMRM) with fixed, categorical factors of treatment at each visit, and continuous factors of baseline at each visit, using visit (Week 2, 3, 4, 5, 6, 7, 8, 12, 16 and 17 ) as repeated measures, subject as random effect, unstructured covariance matrix to model within subject measurements.||1.03|-2.34|0.4439
72520026|NCT04153929|144569326|OTHER|No formal hypotheses were tested.|Difference of adjusted means|-3.28||||0.0001|TWO_SIDED|95.0|-4.95|-1.61||P-value is considered nominal.|Mixed Model for Repeated Measures (MMRM)|Kenward-Roger was used to estimate denominator degrees of freedom.|"Difference was calculated as BI 456906 0.9 mg - Placebo at Week 17."|Mixed Model Repeated Measures (MMRM) with fixed, categorical factors of treatment at each visit, and continuous factors of baseline at each visit, using visit (Week 2, 3, 4, 5, 6, 7, 8, 12, 16 and 17 ) as repeated measures, subject as random effect, unstructured covariance matrix to model within subject measurements.||-1.61|-4.95|0.0001
72405760|NCT01956110|144319971|EQUIVALENCE|Treatment groups were compared using a chi-square test.|||||=|0.178|||||||Chi-squared|||Treatment comparison: Investigator-requested gonadotropin dose adjustments||||=0.178
72405761|NCT01956110|144319977|OTHER|Nested logistic regression models were compared using the likelihood ratio test. The full logistic regression model included treatment as factor, log(AMH) as covariate and the interaction term. The nested model did not include treatment and the interaction term.||||||0.32||||||Inclusion of treatment does not provide a better fit to the data.|Likelihood ratio test|Likelihood ratio test comparing the reduced model including only AMH to the full model including AMH, treatment group and interactions.||Treatment comparison: Late OHSS (any grade)||||0.320
72405762|NCT01956110|144319977|OTHER|Nested logistic regression models were compared using the likelihood ratio test. The full logistic regression model included treatment as factor, log(AMH) as covariate and the interaction term. The nested model did not include treatment and the interaction term.||||||0.39||||||Inclusion of treatment does not provide a better fit to the data.|Likelihood ratio test|Likelihood ratio test comparing the reduced model including only AMH to the full model including AMH, treatment group and interactions.||Treatment comparison: Late OHSS (moderate/severe)||||0.390
72405763|NCT02506816|144320016|OTHER|The P-valor Wilcoxon method is a non-parametric statistical hypothesis test used to evaluate changes from baseline H-score values of the three biomarkers.||||||0.033||||||In order to adjust the multiple comparisons made, Benjamini-Hochberg's false discovery rate (FDR) 10% method was used.|Wilcoxon (Mann-Whitney)|||After having analyzed the H-score for each of 3 biomarkers, we calculated the change from baseline subtracting post-treatment H-score from baseline H-score. Data were expressed as mean value and relative standard deviation.||||0.033
72405764|NCT02506816|144320017|OTHER|The differences in the change from baseline of different biomarkers were evaluated by the P-valor Wilcoxon method, a non-parametric statistical hypothesis test.||||||0.03||||||In order to adjust the multiple comparisons made, Benjamini-Hochberg's false discovery rate (FDR) 10% method was used.|Wilcoxon (Mann-Whitney)|||After having analyzed the H-score for each of several biomarkers, we calculated the change from baseline subtracting post-treatment H-score from baseline H-score. Data were expressed as mean value and relative standard deviation.||||0.03
72520027|NCT04153929|144569326|OTHER|No formal hypotheses were tested.|Difference of adjusted means|-4.93|||<|0.0001|TWO_SIDED|95.0|-6.62|-3.23||P-value is considered nominal|Mixed Model for Repeated Measures (MMRM)|Kenward-Roger was used to estimate denominator degrees of freedom.|"Difference was calculated as BI 456906 1.8 mg - Placebo at Week 17."|Mixed Model Repeated Measures (MMRM) with fixed, categorical factors of treatment at each visit, and continuous factors of baseline at each visit, using visit (Week 2, 3, 4, 5, 6, 7, 8, 12, 16 and 17 ) as repeated measures, subject as random effect, unstructured covariance matrix to model within subject measurements.||-3.23|-6.62|<0.0001
72569780|NCT02944383|144670002|SUPERIORITY|||||||0.1222||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||LDL Particles||||0.1222
72569781|NCT02944383|144670002|SUPERIORITY|||||||0.0734||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||IDL Particles||||0.0734
72520028|NCT04153929|144569326|OTHER|No formal hypotheses were tested.|Difference of adjusted means|-5.76|||<|0.0001|TWO_SIDED|95.0|-7.53|-4.0||P-value is considered nominal.|Mixed Model for Repeated Measures (MMRM)|Kenward-Roger was used to estimate denominator degrees of freedom.|"Difference was calculated as BI 456906 2.7 mg - Placebo at Week 17."|Mixed Model Repeated Measures (MMRM) with fixed, categorical factors of treatment at each visit, and continuous factors of baseline at each visit, using visit (Week 2, 3, 4, 5, 6, 7, 8, 12, 16 and 17 ) as repeated measures, subject as random effect, unstructured covariance matrix to model within subject measurements.||-4.00|-7.53|<0.0001
72520029|NCT04153929|144569326|OTHER|No formal hypotheses were tested.|Difference of adjusted means|-5.44|||<|0.0001|TWO_SIDED|95.0|-7.11|-3.77||P-value is considered nominal.|Mixed Model for Repeated Measures (MMRM)|Kenward-Roger was used to estimate denominator degrees of freedom.|"Difference was calculated as BI 456906 1.2 twice weekly (2.4) mg - Placebo at Week 17."|Mixed Model Repeated Measures (MMRM) with fixed, categorical factors of treatment at each visit, and continuous factors of baseline at each visit, using visit (Week 2, 3, 4, 5, 6, 7, 8, 12, 16 and 17 ) as repeated measures, subject as random effect, unstructured covariance matrix to model within subject measurements.||-3.77|-7.11|<0.0001
72520030|NCT04153929|144569326|OTHER|No formal hypotheses were tested.|Difference of adjusted means|-7.05|||<|0.0001|TWO_SIDED|95.0|-8.79|-5.31||P-value is considered nominal.|Mixed Model for Repeated Measures (MMRM)|Kenward-Roger was used to estimate denominator degrees of freedom.|"Difference was calculated as BI 456906 1.8 twice weekly (3.6) mg - Placebo at Week 17."|Mixed Model Repeated Measures (MMRM) with fixed, categorical factors of treatment at each visit, and continuous factors of baseline at each visit, using visit (Week 2, 3, 4, 5, 6, 7, 8, 12, 16 and 17 ) as repeated measures, subject as random effect, unstructured covariance matrix to model within subject measurements.||-5.31|-8.79|<0.0001
72542512|NCT03001011|144614812|SUPERIORITY||Median difference (Renvela - Placebo)|-0.21|||<|0.0001|TWO_SIDED|||||Threshold for statistical significance at 0.05.|Wilcoxon rank sum test||Renvela Vs. Placebo|A hierarchical testing procedure was used to control type I error \& handle multiple secondary endpoint analyses. Testing was then performed sequentially in order outcome measures (OM) are reported. The hierarchical testing sequence continued only when previous OM was statistically significant at 0.05 level.||||<0.0001
72405765|NCT03762083|144320024|OTHER|The clinical performance endpoint - Clinical cure rate on Day 7 - was calculated and presented together with a one-sided 95% CI based on the exact binomial distribution (Clopper-Pearson).|Clinical cure rate|81.9|||||ONE_SIDED|95.0|63.1|||||||"It was assumed that the true cure rate was equal to 70%, therefore 22 patients were needed to obtain 90% chance (90% power) to show that the one-sided 95% confidence interval (CI) for the observed cure rate was above 40%.~Hypotheses for the primary clinical performance endpoint:~* Null hypothesis: Clinical cure rate is less than or equal to 40%.~* Alternative hypothesis (one-sided): Clinical cure rate is above 40%."|||63.1|
72405766|NCT03762083|144320025|OTHER|Results are based on the exact binomial distribution (Clopper-Pearson).|Prop. negative for Amsel criterion 1.|85.7|||||TWO_SIDED|95.0|63.7|97.0||||||||97.0|63.7|
72405767|NCT03762083|144320026|OTHER|Results are based on the exact binomial distribution (Clopper-Pearson).|Prop. negative for Amsel criterion 2.|90.0|||||TWO_SIDED|95.0|68.3|98.8||||||||98.8|68.3|
72405768|NCT03762083|144320027|OTHER|Results are based on the exact binomial distribution (Clopper-Pearson).|Prop. negative for Amsel criterion 3.|86.4|||||TWO_SIDED|95.0|65.1|97.1||||||||97.1|65.1|
72405769|NCT03762083|144320029|OTHER|Results are based on the exact binomial distribution (Clopper-Pearson).|Recurrence rate Day 14|5.6|||||TWO_SIDED|95.0|0.1|27.3||||||||27.3|0.1|
72405770|NCT03762083|144320029|OTHER|Results are based on the exact binomial distribution (Clopper-Pearson).|Recurrence rate Day 35|0.0|||||TWO_SIDED|95.0|0.0|20.6||||||||20.6|0|
72405771|NCT05583903|144320049|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.00
72405772|NCT05583903|144320050|SUPERIORITY|||||||0.26|||||||Fisher Exact|||||||0.26
72405773|NCT05583903|144320051|SUPERIORITY|||||||0.57|||||||Wilcoxon (Mann-Whitney)|||||||0.57
72405774|NCT05583903|144320052|SUPERIORITY|||||||0.2|||||||Wilcoxon (Mann-Whitney)|||||||0.2
72405775|NCT05583903|144320053|SUPERIORITY|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||||||0.001
72405776|NCT05583903|144320054|SUPERIORITY|||||||0.21|||||||Wilcoxon (Mann-Whitney)|||||||0.21
72405777|NCT05583903|144320055|SUPERIORITY|||||||0.66|||||||Wilcoxon (Mann-Whitney)|||||||0.66
72405778|NCT05583903|144320056|SUPERIORITY|||||||0.77|||||||Wilcoxon (Mann-Whitney)|||||||0.77
72405779|NCT05583903|144320057|SUPERIORITY|||||||0.71|||||||Wilcoxon (Mann-Whitney)|||||||0.71
72405780|NCT05583903|144320058|SUPERIORITY|||||||0.36|||||||Wilcoxon (Mann-Whitney)|||||||0.36
72542513|NCT00065065|144614836|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.0||||0.005||95.0|1.5|10.5|||Regression, Logistic|||||10.5|1.5|.005
72405781|NCT05583903|144320059|SUPERIORITY|||||||0.43|||||||Wilcoxon (Mann-Whitney)|||||||0.43
72405782|NCT05583903|144320060|SUPERIORITY|||||||0.23|||||||Wilcoxon (Mann-Whitney)|||||||0.23
72405783|NCT05583903|144320061|SUPERIORITY|||||||0.63|||||||Wilcoxon (Mann-Whitney)|||||||0.63
72405784|NCT05583903|144320062|SUPERIORITY|||||||0.52|||||||Wilcoxon (Mann-Whitney)|||||||0.52
72405785|NCT05583903|144320063|SUPERIORITY|||||||0.4|||||||Wilcoxon (Mann-Whitney)|||||||0.4
72405786|NCT01103934|144320075|SUPERIORITY_OR_OTHER|||||||0.09|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.09
72405787|NCT01103934|144320076|SUPERIORITY_OR_OTHER|||||||0.04|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.04
72542514|NCT01241565|144614839|SUPERIORITY_OR_OTHER||Rate of incidence of PAL|10.6|||||TWO_SIDED|95.0|3.9|21.3|||||Incidence of Prolonged Air Leak (PAL) is estimated at between 5-10% in literature. PAL of 10%of evaluable cases was used to determine study success.|||21.3|3.9|
72542515|NCT02278952|144614878|OTHER|Generalized estimating equation-adjusted linear models||||||0.33|||||||GEE-adjusted models|||||||0.33
72542516|NCT02278952|144614879|OTHER|Generalized estimating equation-adjusted linear model|||||<|0.0001|||||||GEE-adjusted linear model|||||||< 0.0001
72542517|NCT02278952|144614880|OTHER|Generalized estimating equation-adjusted linear models||||||0.049|||||||GEE-adjusted linear models|||||||0.049
72542518|NCT02278952|144614881|OTHER|Generalized estimating equation-adjusted linear models||||||0.114|||||||GEE-adjusted linear models|||||||0.114
72405788|NCT04889625|144320088|NON_INFERIORITY|This study was powered to demonstrate non-inferiority of the Test lens relative to the Control lens with respect to binocular HLHC distance, intermediate and near visual acuity. A non-inferiority margin of 0.05 logMAR was used; (0.05) logMAR is approximately half a line on an ETDRS chart.|least-square mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.0085|||TWO_SIDED|95.0|-0.017|0.017|||Mixed Model Analysis|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.|Mean difference was calculated as senofilcon A - delefilcon A|Distance (4m)||0.017|-0.017|
72405789|NCT04889625|144320088|NON_INFERIORITY|This study was powered to demonstrate non-inferiority of the Test lens relative to the Control lens with respect to binocular HLHC distance, intermediate and near visual acuity. A non-inferiority margin of 0.05 logMAR was used; (0.05) logMAR is approximately half a line on an ETDRS chart.|least-square mean difference|-0.03|STANDARD_ERROR_OF_MEAN|0.0108|||TWO_SIDED|95.0|-0.051|-0.008|||Mixed Model Analysis|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.|Mean difference was calculated as senofilcon A - delefilcon A|Intermediate (64cm)||-0.008|-0.051|
72520031|NCT04153929|144569326|OTHER|No formal hypotheses were tested.|Difference of adjusted means|-3.85|||<|0.0001|TWO_SIDED|95.0|-5.52|-2.18||P-value is considered nominal.|Mixed Model Repeated Measures (MMRM)|Kenward-Roger was used to estimate denominator degrees of freedom.|"Difference was calculated as Semaglutide - Placebo at Week 17."|Mixed Model Repeated Measures (MMRM) with fixed, categorical factors of treatment at each visit, and continuous factors of baseline at each visit, using visit (Week 2, 3, 4, 5, 6, 7, 8, 12, 16 and 17 ) as repeated measures, subject as random effect, unstructured covariance matrix to model within subject measurements.||-2.18|-5.52|<0.0001
72520032|NCT04153929|144569327|OTHER|No formal hypotheses were tested.|Difference of adjusted means|-0.62||||0.7708|TWO_SIDED|95.0|-4.82|3.57||P-value is considered nominal.|Mixed Model for Repeated Measures (MMRM)|Kenward-Roger was used to estimate denominator degrees of freedom.|"Difference was calculated as BI 456906 0.3 mg - Placebo at Week 17."|Mixed Model Repeated Measures (MMRM) with fixed, categorical factors of treatment at each visit, and continuous factors of baseline at each visit, using visit (Week 6 and 17 ) as repeated measures, subject as random effect, unstructured covariance matrix to model within subject measurements.||3.57|-4.82|0.7708
72520033|NCT04153929|144569327|OTHER|No formal hypotheses were tested.|Difference of adjusted means|0.68||||0.7462|TWO_SIDED|95.0|-3.44|4.79||P-value is considered nominal.|Mixed Model for Repeated Measures (MMRM)|Kenward-Roger was used to estimate denominator degrees of freedom.|"Difference was calculated as BI 456906 0.9 mg - Placebo at Week 17."|Mixed Model Repeated Measures (MMRM) with fixed, categorical factors of treatment at each visit, and continuous factors of baseline at each visit, using visit (Week 6 and 17 ) as repeated measures, subject as random effect, unstructured covariance matrix to model within subject measurements.||4.79|-3.44|0.7462
72520034|NCT04153929|144569327|OTHER|No formal hypotheses were tested.|Difference of adjusted means|-3.32||||0.1302|TWO_SIDED|95.0|-7.62|0.98||P-value is considered nominal.|Mixed Model for Repeated Measures (MMRM)|Kenward-Roger was used to estimate denominator degrees of freedom.|"Difference was calculated as BI 456906 1.8 mg - Placebo at Week 17."|Mixed Model Repeated Measures (MMRM) with fixed, categorical factors of treatment at each visit, and continuous factors of baseline at each visit, using visit (Week 6 and 17 ) as repeated measures, subject as random effect, unstructured covariance matrix to model within subject measurements.||0.98|-7.62|0.1302
72520035|NCT04153929|144569327|OTHER|No formal hypotheses were tested.|Difference of adjusted means|-4.61||||0.0414|TWO_SIDED|95.0|-9.03|-0.18||P-value is considered nominal.|Mixed Model for Repeated Measures (MMRM)|Kenward-Roger was used to estimate denominator degrees of freedom.|"Difference was calculated as BI 456906 2.7 mg - Placebo at Week 17."|Mixed Model Repeated Measures (MMRM) with fixed, categorical factors of treatment at each visit, and continuous factors of baseline at each visit, using visit (Week 6 and 17 ) as repeated measures, subject as random effect, unstructured covariance matrix to model within subject measurements.||-0.18|-9.03|0.0414
72520036|NCT04153929|144569327|OTHER|No formal hypotheses were tested.|Difference of adjusted means|-2.55||||0.2273|TWO_SIDED|95.0|-6.71|1.6||P-value is considered nominal.|Mixed Model for Repeated Measures (MMRM)|Kenward-Roger was used to estimate denominator degrees of freedom.|"Difference was calculated as BI 456906 1.2 twice weekly (2.4) mg - Placebo at Week 17."|Mixed Model Repeated Measures (MMRM) with fixed, categorical factors of treatment at each visit, and continuous factors of baseline at each visit, using visit (Week 6 and 17 ) as repeated measures, subject as random effect, unstructured covariance matrix to model within subject measurements.||1.60|-6.71|0.2273
72542519|NCT02278952|144614882|OTHER|Generalized estimating equation-adjusted linear models||||||0.47|||||||GEE-adjusted linear models|||P-value of tacrolimus dose||||0.470
72624962|NCT02757768|144779453|SUPERIORITY||LS Mean of Difference|0.9|STANDARD_ERROR_OF_MEAN|1.54||0.559|TWO_SIDED|95.0|-2.12|3.92|||ANCOVA|||Week 12 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||3.92|-2.12|0.559
72405790|NCT04889625|144320088|NON_INFERIORITY|This study was powered to demonstrate non-inferiority of the Test lens relative to the Control lens with respect to binocular HLHC distance, intermediate and near visual acuity. A non-inferiority margin of 0.05 logMAR was used; (0.05) logMAR is approximately half a line on an ETDRS chart.|least-square mean difference|-0.036|STANDARD_ERROR_OF_MEAN|0.0129|||TWO_SIDED|95.0|-0.062|-0.011|||Mixed Model Analysis|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.|Mean difference was calculated as senofilcon A - delefilcon A|Near (40cm)||-0.011|-0.062|
72624963|NCT02757768|144779453|SUPERIORITY||LS Mean of Difference|0.03|STANDARD_ERROR_OF_MEAN|1.51||0.985|TWO_SIDED|95.0|-2.94|3.0|||ANCOVA|||EoT Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||3.00|-2.94|0.985
72624964|NCT02757768|144779454|SUPERIORITY||LS Mean of Difference|-1.82|STANDARD_ERROR_OF_MEAN|1.29||0.161|TWO_SIDED|95.0|-4.35|0.72|||ANCOVA|||Week 4 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||0.72|-4.35|0.161
72405791|NCT04889625|144320089|NON_INFERIORITY|This study was powered to demonstrate the primary hypotheses. However, the final sample size calculation was deemed large enough to test for Non-inferiority of the Test relative to the Control. A non-inferiority margin of -5 points was used.|least-square mean difference|6.3|STANDARD_ERROR_OF_MEAN|2.12|||TWO_SIDED|95.0|2.0|10.5|||Mixed Model Analysis|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.|Mean difference was calculated as senofilcon A (C3)- delefilcon A|||10.5|2.0|
72405792|NCT03746522|144320092|OTHER|||||||0.0006||||||P-value was one-sided and compared with alpha = 0.025.|Rubin's Rule|||||||0.0006
72405793|NCT03746522|144320093|OTHER|||||||0.0005||||||p-value was one-sided and compared with alpha = 0.025|Rubin's Rule|||||||0.0005
72520037|NCT04153929|144569327|OTHER|No formal hypotheses were tested.|Difference of adjusted means|-8.4||||0.0002|TWO_SIDED|95.0|-12.81|-3.98||P-value is considered nominal.|Mixed Model for Repeated Measures (MMRM)|Kenward-Roger was used to estimate denominator degrees of freedom.|"Difference was calculated as BI 456906 1.8 twice weekly (3.6) mg - Placebo at Week 17."|Mixed Model Repeated Measures (MMRM) with fixed, categorical factors of treatment at each visit, and continuous factors of baseline at each visit, using visit (Week 6 and 17 ) as repeated measures, subject as random effect, unstructured covariance matrix to model within subject measurements.||-3.98|-12.81|0.0002
72520038|NCT04153929|144569327|OTHER|No formal hypotheses were tested.|Difference of adjusted means|-2.72||||0.1967|TWO_SIDED|95.0|-6.86|1.42||P-value is considered nominal.|Mixed Model Repeated Measures (MMRM)|Kenward-Roger was used to estimate denominator degrees of freedom.|"Difference was calculated as Semaglutide - Placebo at Week 17."|Mixed Model Repeated Measures (MMRM) with fixed, categorical factors of treatment at each visit, and continuous factors of baseline at each visit, using visit (Week 6 and 17 ) as repeated measures, subject as random effect, unstructured covariance matrix to model within subject measurements.||1.42|-6.86|0.1967
72520039|NCT04153929|144569328|OTHER||Odds Ratio (OR)|1.22|||||TWO_SIDED|95.0|0.28|5.2|||||Odds Ratio was calculated as BI 456906 / Placebo.|Method: Logistic regression model for body weight loss with treatment as fixed effect.||5.20|0.28|
72520040|NCT04153929|144569328|OTHER||Odds Ratio (OR)|7.92|||||TWO_SIDED|95.0|2.43|25.74|||||Odds Ratio was calculated as BI 456906 / Placebo.|Method: Logistic regression model for body weight loss with treatment as fixed effect.||25.74|2.43|
72405794|NCT03746522|144320094|OTHER||||||<|0.0001||||||p-value was one-sided and compared with alpha=0.025.|Rubin's Rule|||||||<0.0001
72405795|NCT03746522|144320095|OTHER||||||<|0.0001||||||p-value was one-sided and compared with alpha = 0.025.|Rubin's Rule|||||||<0.0001
72405796|NCT02659020|144320123|SUPERIORITY||Hazard Ratio (HR)|0.945||||0.775|TWO_SIDED|95.0|0.639|1.397||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and Eastern Cooperative Oncology Group Performance Status (ECOG PS) (0 vs1).|Log Rank||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|||1.397|0.639|0.775
72405797|NCT02659020|144320133|SUPERIORITY||Hazard Ratio (HR)|0.667||||0.148|TWO_SIDED|95.0|0.385|1.158||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|Log Rank||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|||1.158|0.385|0.148
72405798|NCT02659020|144320134|SUPERIORITY||Hazard Ratio (HR)|0.692||||0.055|TWO_SIDED|95.0|0.476|1.007||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|Log Rank||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|||1.007|0.476|0.055
72520041|NCT04153929|144569328|OTHER||Odds Ratio (OR)|17.68|||||TWO_SIDED|95.0|5.21|60.03|||||Odds Ratio was calculated as BI 456906 / Placebo.|Method: Logistic regression model for body weight loss with treatment as fixed effect.||60.03|5.21|
72520042|NCT04153929|144569328|OTHER||Odds Ratio (OR)|25.87|||||TWO_SIDED|95.0|7.31|91.55|||||Odds Ratio was calculated as BI 456906 / Placebo.|Method: Logistic regression model for body weight loss with treatment as fixed effect.||91.55|7.31|
72520043|NCT04153929|144569328|OTHER||Odds Ratio (OR)|21.75|||||TWO_SIDED|95.0|6.57|72.04|||||Odds Ratio was calculated as BI 456906 / Placebo.|Method: Logistic regression model for body weight loss with treatment as fixed effect.||72.04|6.57|
72569782|NCT02944383|144670002|SUPERIORITY|||||||0.421||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||IDL Particles||||0.4210
72569783|NCT02944383|144670003|SUPERIORITY||Median Difference (Net)|0.43||||0.9672|TWO_SIDED|95.0|-8.12|9.07||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|||9.07|-8.12|0.9672
72569784|NCT02944383|144670003|SUPERIORITY||Median Difference (Net)|1.58||||0.7993|TWO_SIDED|95.0|-5.31|8.69||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|||8.69|-5.31|0.7993
72569785|NCT02944383|144670004|SUPERIORITY|||||||0.8602||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||||||0.8602
72569786|NCT02944383|144670004|SUPERIORITY|||||||0.8555||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||||||0.8555
72405799|NCT02659020|144320134|SUPERIORITY||Hazard Ratio (HR)|0.828||||0.482|TWO_SIDED|95.0|0.49|1.398||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|Log Rank|||||1.398|0.490|0.482
72405800|NCT02659020|144320135|SUPERIORITY||Odds Ratio (OR)|1.589||||0.1891|TWO_SIDED|95.0|0.794|3.179||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|Exact Mantel-Haenszel test||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|||3.179|0.794|0.1891
72405801|NCT02659020|144320135|SUPERIORITY||Odds Ratio (OR)|2.668||||0.0642|TWO_SIDED|95.0|0.923|7.71||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|Exact Mantel-Haenszel test||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|||7.710|0.923|0.0642
72520044|NCT04153929|144569328|OTHER||Odds Ratio (OR)|35.0|||||TWO_SIDED|95.0|9.84|124.47|||||Odds Ratio was calculated as BI 456906 / Placebo.|Method: Logistic regression model for body weight loss with treatment as fixed effect.||124.47|9.84|
72520045|NCT04153929|144569328|OTHER||Odds Ratio (OR)|8.22|||||TWO_SIDED|95.0|2.52|26.79|||||Odds Ratio was calculated as Semaglutide / Placebo.|Method: Logistic regression model for body weight loss with treatment as fixed effect.||26.79|2.52|
72520046|NCT04153929|144569329|OTHER||Odds Ratio (OR)|3.67|||||TWO_SIDED|95.0|0.14|95.73|||||Odds Ratio was calculated as BI 456906 / Placebo.|Method: Logistic regression model using Firth's bias-reducing penalized maximum likelihood estimation for body weight loss with treatment as fixed effect.||95.73|0.14|
72520047|NCT04153929|144569329|OTHER||Odds Ratio (OR)|7.97|||||TWO_SIDED|95.0|0.39|163.56|||||Odds Ratio was calculated as BI 456906 / Placebo.|Method: Logistic regression model using Firth's bias-reducing penalized maximum likelihood estimation for body weight loss with treatment as fixed effect.||163.56|0.39|
72520048|NCT04153929|144569329|OTHER||Odds Ratio (OR)|25.17|||||TWO_SIDED|95.0|1.35|471.09|||||Odds Ratio was calculated as BI 456906 / Placebo.|Method: Logistic regression model using Firth's bias-reducing penalized maximum likelihood estimation for body weight loss with treatment as fixed effect.||471.09|1.35|
72520049|NCT04153929|144569329|OTHER||Odds Ratio (OR)|33.01|||||TWO_SIDED|95.0|1.78|613.51||||||Method: Logistic regression model using Firth's bias-reducing penalized maximum likelihood estimation for body weight loss with treatment as fixed effect.||613.51|1.78|
72520050|NCT04153929|144569329|OTHER||Odds Ratio (OR)|42.44|||||TWO_SIDED|95.0|2.37|761.44|||||Odds Ratio was calculated as BI 456906 / Placebo.|Method: Logistic regression model using Firth's bias-reducing penalized maximum likelihood estimation for body weight loss with treatment as fixed effect.||761.44|2.37|
72520051|NCT04153929|144569329|OTHER||Odds Ratio (OR)|84.53|||||TWO_SIDED|95.0|4.71|999.0|||||Odds Ratio was calculated as BI 456906 / Placebo. The upper limit is bigger than 999.|Method: Logistic regression model using Firth's bias-reducing penalized maximum likelihood estimation for body weight loss with treatment as fixed effect.||999|4.71|
72624965|NCT02757768|144779454|SUPERIORITY||LS Mean of Difference|0.35|STANDARD_ERROR_OF_MEAN|1.38||0.798|TWO_SIDED|95.0|-2.36|3.07|||ANCOVA|||Week 8 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||3.07|-2.36|0.798
72624966|NCT02757768|144779454|SUPERIORITY||LS Mean of Difference|1.17|STANDARD_ERROR_OF_MEAN|1.42||0.408|TWO_SIDED|95.0|-1.61|3.95|||ANCOVA|||Week 12 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||3.95|-1.61|0.408
72624967|NCT02757768|144779454|SUPERIORITY||LS Mean of Difference|0.14|STANDARD_ERROR_OF_MEAN|1.39||0.919|TWO_SIDED|95.0|-2.6|2.88|||ANCOVA|||EoT Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||2.88|-2.60|0.919
72624968|NCT02757768|144779455|SUPERIORITY||LS Mean of Difference|-0.02|STANDARD_ERROR_OF_MEAN|1.49||0.99|TWO_SIDED|95.0|-2.94|2.91|||ANCOVA|||Week 4 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||2.91|-2.94|0.990
72520052|NCT04153929|144569329|OTHER||Odds Ratio (OR)|22.44|||||TWO_SIDED|95.0|1.22|413.33|||||Odds Ratio was calculated as Semaglutide / Placebo.|Method: Logistic regression model using Firth's bias-reducing penalized maximum likelihood estimation for body weight loss with treatment as fixed effect.||413.33|1.22|
72520053|NCT01963780|144569330|SUPERIORITY|Performance goal is 65%.|Proportion|0.544||||0.9663|TWO_SIDED|95.0|0.428|0.657|||one-sided exact binomial test|||||0.657|0.428|0.9663
72520054|NCT01963780|144569331|OTHER|No statistical hypothesis testing|Proportion|0.167|||||TWO_SIDED|95.0|0.092|0.268||||||||0.268|0.092|
72520055|NCT01963780|144569332|OTHER|No statistical hypothesis testing|Proportion|0.064|||||TWO_SIDED|95.0|0.021|0.143||||||||0.143|0.021|
72520056|NCT01963780|144569333|OTHER|No statistical hypothesis testing|Mean|0.3|||||TWO_SIDED|95.0|0.1|0.4||||||||0.4|0.1|
72520057|NCT02971293|144569422|SUPERIORITY||||||<|0.001|||||||ANCOVA|Fixed effects: treatment, sequence, period. Random effect for patient nested within sequence. Continuous covariate: baseline.||Comparison of AZD8871 100 µg vs placebo||||<0.001
72542520|NCT02278952|144614882|OTHER|Generalized estimating equation-adjusted linear models||||||0.037|||||||GEE-adjusted linear models|||P-value of Prednisone dose||||0.037
72542521|NCT02278952|144614882|OTHER|Generalized-estimating equation-adjusted linear models||||||0.456|||||||GEE-adjusted linear models|||P-value of mycophenolate mofetil dose||||0.456
72542522|NCT02795780|144614883|OTHER|||||||0.0166||||||No adjustments for multiplicity. No a priori threshold defined.|ANCOVA|Adjusted for baseline SUVr, age, and diagnosis group (AD/MCI)||Test of whether difference in least squares mean change is 0||||0.0166
72542523|NCT02795780|144614883|OTHER|||||||0.0108||||||No adjustments for multiplicity. No a priori threshold defined.|ANCOVA|Adjusted for baseline SUVr, age, and diagnosis group (AD/MCI)||Test of whether difference in least squares mean change is 0||||0.0108
72520058|NCT02971293|144569422|SUPERIORITY||||||<|0.001|||||||ANCOVA|Fixed effects: treatment, sequence, period. Random effect for patient nested within sequence. Continuous covariate: baseline.||Comparison of AZD8871 600 µg vs placebo||||<0.001
72520059|NCT02971293|144569422|SUPERIORITY|||||||0.02|||||||ANCOVA|Fixed effects: treatment, sequence, period. Random effect for patient nested within sequence. Continuous covariate: baseline.||Comparison of AZD8871 600 µg vs AZD8871 100 µg||||0.020
72520060|NCT02971293|144569434|SUPERIORITY|||||||0.002|||||||ANCOVA|Fixed effects: treatment, sequence, period. Random effect for patient nested within sequence. Continuous covariate: baseline.||Comparison of AZD8871 100 µg vs placebo||||0.002
72520061|NCT02971293|144569434|SUPERIORITY||||||<|0.001|||||||ANCOVA|Fixed effects: treatment, sequence, period. Random effect for patient nested within sequence. Continuous covariate: baseline.||Comparison of AZD8871 600 µg vs placebo||||<0.001
72520062|NCT02971293|144569434|SUPERIORITY|||||||0.011|||||||ANCOVA|Fixed effects: treatment, sequence, period. Random effect for patient nested within sequence. Continuous covariate: baseline.||Comparison of AZD8871 600 µg vs AZD8871 100 µg||||0.011
72520063|NCT02971293|144569435|SUPERIORITY||||||<|0.001|||||||ANCOVA|Fixed effects: treatment, sequence, period. Random effect for patient nested within sequence. Continuous covariate: baseline.||Comparison of AZD8871 100 µg vs placebo||||<0.001
72520064|NCT02971293|144569435|SUPERIORITY||||||<|0.001|||||||ANCOVA|Fixed effects: treatment, sequence, period. Random effect for patient nested within sequence. Continuous covariate: baseline.||Comparison of AZD8871 600 µg vs placebo||||<0.001
72520065|NCT02971293|144569435|SUPERIORITY|||||||0.201|||||||ANCOVA|Fixed effects: treatment, sequence, period. Random effect for patient nested within sequence. Continuous covariate: baseline.||Comparison of AZD8871 600 µg vs AZD8871 100 µg||||0.201
72520066|NCT02971293|144569436|SUPERIORITY||||||<|0.001|||||||ANCOVA|Fixed effect: treatment, sequence, period, treatment\*day. Repeat factor: day. Random effect: patient nested in sequence. Continuous covar: baseline.||Comparison of AZD8871 100 µg vs placebo||||<0.001
72520067|NCT02971293|144569436|SUPERIORITY||||||<|0.001|||||||ANCOVA|Fixed effect: treatment, sequence, period, treatment\*day. Repeat factor: day. Random effect: patient nested in sequence. Continuous covar: baseline.||Comparison of AZD8871 600 µg vs placebo||||<0.001
72520068|NCT02971293|144569436|SUPERIORITY|||||||0.02|||||||ANCOVA|Fixed effect: treatment, sequence, period, treatment\*day. Repeat factor: day. Random effect: patient nested in sequence. Continuous covar: baseline.||Comparison of AZD8871 600 µg vs AZD8871 100 µg||||0.020
72520069|NCT02971293|144569437|SUPERIORITY||||||<|0.001|||||||ANCOVA|Fixed effects: treatment, sequence, period. Random effect for patient nested within sequence. Continuous covariate: baseline.||Comparison of AZD8871 100 µg vs placebo||||<0.001
72520070|NCT02971293|144569437|SUPERIORITY||||||<|0.001|||||||ANCOVA|Fixed effects: treatment, sequence, period. Random effect for patient nested within sequence. Continuous covariate: baseline.||Comparison of AZD8871 600 µg vs placebo||||<0.001
72520071|NCT02971293|144569437|SUPERIORITY||||||<|0.001|||||||ANCOVA|Fixed effects: treatment, sequence, period. Random effect for patient nested within sequence. Continuous covariate: baseline.||Comparison of AZD8871 600 µg vs AZD8871 100 µg||||<0.001
72520072|NCT02971293|144569438|SUPERIORITY||||||<|0.001|||||||ANCOVA|Fixed effects: treatment, sequence, period. Random effect for patient nested within sequence. Continuous covariate: baseline.||Comparison of AZD8871 100 µg vs placebo||||<0.001
72520073|NCT02971293|144569438|SUPERIORITY||||||<|0.001|||||||ANCOVA|Fixed effects: treatment, sequence, period. Random effect for patient nested within sequence. Continuous covariate: baseline.||Comparison of AZD8871 600 µg vs placebo||||<0.001
72520074|NCT02971293|144569438|SUPERIORITY|||||||0.092|||||||ANCOVA|Fixed effects: treatment, sequence, period. Random effect for patient nested within sequence. Continuous covariate: baseline.||Comparison of AZD8871 600 µg vs AZD8871 100 µg||||0.092
72520075|NCT02971293|144569439|SUPERIORITY||||||<|0.001|||||||ANCOVA|Fixed effects: treatment, sequence, period. Random effect for patient nested within sequence. Continuous covariate: baseline.||Comparison of AZD8871 100 µg vs placebo||||<0.001
72520076|NCT02971293|144569439|SUPERIORITY||||||<|0.001|||||||ANCOVA|Fixed effects: treatment, sequence, period. Random effect for patient nested within sequence. Continuous covariate: baseline.||Comparison of AZD8871 600 µg vs placebo||||<0.001
72520077|NCT02971293|144569439|SUPERIORITY|||||||0.279|||||||ANCOVA|Fixed effects: treatment, sequence, period. Random effect for patient nested within sequence. Continuous covariate: baseline.||Comparison of AZD8871 600 µg vs AZD8871 100 µg||||0.279
72520078|NCT02971293|144569440|SUPERIORITY||||||<|0.001|||||||ANCOVA|Fixed effect: treatment, sequence, period, treatment\*day. Repeat factor: day. Random effect: patient nested in sequence. Continuous covar: baseline.||Comparison of AZD8871 100 µg vs placebo||||<0.001
72520079|NCT02971293|144569440|SUPERIORITY||||||<|0.001|||||||ANCOVA|Fixed effect: treatment, sequence, period, treatment\*day. Repeat factor: day. Random effect: patient nested in sequence. Continuous covar: baseline.||Comparison of AZD8871 600 µg vs placebo||||<0.001
72520080|NCT02971293|144569440|SUPERIORITY||||||<|0.001|||||||ANCOVA|Fixed effect: treatment, sequence, period, treatment\*day. Repeat factor: day. Random effect: patient nested in sequence. Continuous covar: baseline.||Comparison of AZD8871 600 µg vs AZD8871 100 µg||||<0.001
72520081|NCT02971293|144569441|SUPERIORITY|||||||0.205|||||||ANCOVA|Fixed effects: treatment, sequence, period. Random effect for patient nested within sequence. Continuous covariate: baseline.||Comparison of AZD8871 100 µg vs placebo||||0.205
72520082|NCT02971293|144569441|SUPERIORITY|||||||0.002|||||||ANCOVA|Fixed effects: treatment, sequence, period. Random effect for patient nested within sequence. Continuous covariate: baseline.||Comparison of AZD8871 600 µg vs placebo||||0.002
72520083|NCT02971293|144569441|SUPERIORITY|||||||0.06|||||||ANCOVA|Fixed effects: treatment, sequence, period. Random effect for patient nested within sequence. Continuous covariate: baseline.||Comparison of AZD8871 600 µg vs AZD8871 100 µg||||0.060
72520084|NCT02971293|144569442|SUPERIORITY|||||||0.111|||||||ANCOVA|Fixed effects: treatment, sequence, period. Random effect for patient nested within sequence. Continuous covariate: baseline.||Comparison of AZD8871 100 µg vs placebo||||0.111
72520085|NCT02971293|144569442|SUPERIORITY||||||<|0.001|||||||ANCOVA|Fixed effects: treatment, sequence, period. Random effect for patient nested within sequence. Continuous covariate: baseline.||Comparison of AZD8871 600 µg vs placebo||||<0.001
72520086|NCT02971293|144569442|SUPERIORITY|||||||0.015|||||||ANCOVA|Fixed effects: treatment, sequence, period. Random effect for patient nested within sequence. Continuous covariate: baseline.||Comparison of AZD8871 600 µg vs AZD8871 100 µg||||0.015
72520087|NCT02971293|144569443|SUPERIORITY|||||||0.621|||||||ANCOVA|Fixed effects: treatment, sequence, period. Random effect for patient nested within sequence. Continuous covariate: baseline.||Comparison of AZD8871 100 µg vs placebo||||0.621
72520088|NCT02971293|144569443|SUPERIORITY|||||||0.138|||||||ANCOVA|Fixed effects: treatment, sequence, period. Random effect for patient nested within sequence. Continuous covariate: baseline.||Comparison of AZD8871 600 µg vs placebo||||0.138
72520089|NCT02971293|144569443|SUPERIORITY|||||||0.333|||||||ANCOVA|Fixed effects: treatment, sequence, period. Random effect for patient nested within sequence. Continuous covariate: baseline.||Comparison of AZD8871 600 µg vs AZD8871 100 µg||||0.333
72520090|NCT02971293|144569444|SUPERIORITY|||||||0.748|||||||ANCOVA|Fixed effects: treatment, sequence, period. Random effect for patient nested within sequence. Continuous covariate: baseline.||Comparison of AZD8871 100 µg vs placebo||||0.748
72520091|NCT02971293|144569444|SUPERIORITY|||||||0.005|||||||ANCOVA|Fixed effects: treatment, sequence, period. Random effect for patient nested within sequence. Continuous covariate: baseline.||Comparison of AZD8871 600 µg vs placebo||||0.005
72520092|NCT02971293|144569444|SUPERIORITY|||||||0.013|||||||ANCOVA|Fixed effects: treatment, sequence, period. Random effect for patient nested within sequence. Continuous covariate: baseline.||Comparison of AZD8871 600 µg vs AZD8871 100 µg||||0.013
72520093|NCT02971293|144569445|SUPERIORITY|||||||0.064|||||||ANCOVA|Fixed effects: treatment, sequence, period. Random effect for patient nested within sequence. Continuous covariate: baseline.||Comparison of AZD8871 100 µg vs placebo||||0.064
72520094|NCT02971293|144569445|SUPERIORITY||||||<|0.001|||||||ANCOVA|Fixed effects: treatment, sequence, period. Random effect for patient nested within sequence. Continuous covariate: baseline.||Comparison of AZD8871 600 µg vs placebo||||<0.001
72520095|NCT02971293|144569445|SUPERIORITY|||||||0.03|||||||ANCOVA|Fixed effects: treatment, sequence, period. Random effect for patient nested within sequence. Continuous covariate: baseline.||Comparison of AZD8871 600 µg vs AZD8871 100 µg||||0.030
72520096|NCT02971293|144569446|SUPERIORITY|||||||0.018|||||||ANCOVA|Fixed effects: treatment, sequence, period. Random effect for patient nested within sequence. Continuous covariate: baseline.||Comparison of AZD8871 100 µg vs placebo||||0.018
72520097|NCT02971293|144569446|SUPERIORITY||||||<|0.001|||||||ANCOVA|Fixed effects: treatment, sequence, period. Random effect for patient nested within sequence. Continuous covariate: baseline.||Comparison of AZD8871 600 µg vs placebo||||<0.001
72520098|NCT02971293|144569446|SUPERIORITY|||||||0.047|||||||ANCOVA|Fixed effects: treatment, sequence, period. Random effect for patient nested within sequence. Continuous covariate: baseline.||Comparison of AZD8871 600 µg vs AZD8871 100 µg||||0.047
72520099|NCT02971293|144569447|SUPERIORITY|||||||0.477|||||||ANCOVA|Fixed effects: treatment, sequence, period. Random effect for patient nested within sequence. Continuous covariate: baseline.||Comparison of AZD8871 100 µg vs placebo||||0.477
72520100|NCT02971293|144569447|SUPERIORITY|||||||0.014|||||||ANCOVA|Fixed effects: treatment, sequence, period. Random effect for patient nested within sequence. Continuous covariate: baseline.||Comparison of AZD8871 600 µg vs placebo||||0.014
72520101|NCT02971293|144569447|SUPERIORITY|||||||0.084|||||||ANCOVA|Fixed effects: treatment, sequence, period. Random effect for patient nested within sequence. Continuous covariate: baseline.||Comparison of AZD8871 600 µg vs AZD8871 100 µg||||0.084
72520102|NCT02971293|144569448|SUPERIORITY|||||||0.213|||||||ANCOVA|Fixed effects: treatment, sequence, period. Random effect for patient nested within sequence. Continuous covariate: baseline.||Comparison of AZD8871 100 µg vs placebo||||0.213
72520103|NCT02971293|144569448|SUPERIORITY|||||||0.001|||||||ANCOVA|Fixed effects: treatment, sequence, period. Random effect for patient nested within sequence. Continuous covariate: baseline.||Comparison of AZD8871 600 µg vs placebo||||0.001
72520104|NCT02971293|144569448|SUPERIORITY|||||||0.046|||||||ANCOVA|Fixed effects: treatment, sequence, period. Random effect for patient nested within sequence. Continuous covariate: baseline.||Comparison of AZD8871 600 µg vs AZD8871 100 µg||||0.046
72520105|NCT00729326|144569449|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The p-values were not adjusted. The primary measure was change in 24-hour glucose without multiplicity adjustments for other analyses.|ANCOVA|Analyses for continuous variables adjusted for treatment, period, sequence, baseline of the continuous variable.Analysis method was Grizzle's model.||Null hypothesis: The 24-hour average glucose for exenatide was greater than or equal to that for sitagliptin after 4 weeks of treatment. The primary objective was to compare exenatide with sitagliptin on the time-averaged glucose during the 24-hour inpatient periods after 4 weeks of treatment.||||<.001
72520106|NCT00729326|144569450|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||||||<.001
72520107|NCT00729326|144569451|SUPERIORITY_OR_OTHER|||||||0.766||95.0|||||ANCOVA|||||||.766
72520108|NCT00729326|144569452|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||||||<.001
72520109|NCT00729326|144569453|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||||||<.001
72520110|NCT00729326|144569454|SUPERIORITY_OR_OTHER|||||||0.117||95.0|||||ANCOVA|||||||.117
72520111|NCT00729326|144569455|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||||||<.001
72520112|NCT00729326|144569456|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||||||<.001
72520113|NCT00729326|144569457|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||||||<.001
72520114|NCT00729326|144569458|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||||||<.001
72520115|NCT00729326|144569459|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||||||<.001
72520116|NCT00729326|144569460|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||||||<.001
72520117|NCT00729326|144569461|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||||||<.001
72520118|NCT03418051|144569478|SUPERIORITY|||||||0.824||||||A priori alpha level was set to 0.05|ANOVA|||||||0.824
72520119|NCT03418051|144569478|SUPERIORITY|||||||0.426||||||A priori alpha level was set to 0.05.|ANOVA|||||||0.426
72520120|NCT03418051|144569479|SUPERIORITY|||||||0.722||||||A priori alpha level was set to 0.05.|ANOVA|||||||0.722
72520121|NCT03418051|144569479|SUPERIORITY|||||||0.843||||||A priori alpha level was set to 0.05.|ANOVA|||||||0.843
72520122|NCT03418051|144569480|SUPERIORITY|||||||0.046||||||A priori alpha level was set to 0.05.|ANOVA|||||||0.046
72520123|NCT03418051|144569480|SUPERIORITY|||||||0.845||||||A priori alpha level was set to 0.05.|ANOVA|||||||0.845
72520124|NCT03418051|144569481|SUPERIORITY|||||||0.138||||||A priori alpha level was set to 0.05.|ANOVA|||||||0.138
72520125|NCT03418051|144569481|SUPERIORITY|||||||0.523||||||A priori alpha level was set to 0.05.|ANOVA|||||||0.523
72520126|NCT03418051|144569482|SUPERIORITY|||||||0.069||||||A priori alpha level was set to 0.05.|ANOVA|||||||0.069
72520127|NCT03418051|144569482|SUPERIORITY|||||||0.413||||||A priori alpha level was set to 0.05.|ANOVA|||||||0.413
72520128|NCT03418051|144569483|SUPERIORITY|||||||0.604||||||A priori alpha level was set to 0.05.|ANOVA|||||||0.604
72520129|NCT03418051|144569483|SUPERIORITY|||||||0.499||||||A priori alpha level was set to 0.05.|ANOVA|||||||0.499
72520130|NCT03418051|144569484|SUPERIORITY|||||||0.005||||||A priori threshold was set at 0.05.|ANOVA|||||||0.005
72520131|NCT03418051|144569484|SUPERIORITY|||||||0.853||||||A priori threshold set at 0.05.|ANOVA|||||||0.853
72520132|NCT03418051|144569485|SUPERIORITY|||||||0.142||||||A priori threshold set to 0.05|ANOVA|||||||0.142
72520133|NCT03418051|144569485|SUPERIORITY|||||||0.167||||||A priori threshold set at 0.05.|ANOVA|||||||0.167
72520134|NCT03418051|144569486|SUPERIORITY|||||||0.849||||||A priori alpha set at 0.05.|ANOVA|||||||0.849
72520135|NCT03418051|144569486|SUPERIORITY|||||||0.993||||||A priori threshold set at 0.05.|ANOVA|||||||0.993
72569787|NCT02944383|144670005|SUPERIORITY|||||||0.0583||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.0583
72520136|NCT03418051|144569487|SUPERIORITY|||||||0.535||||||A priori alpha level was set to 0.05.|ANOVA|||||||0.535
72520137|NCT03418051|144569487|SUPERIORITY|||||||0.569||||||A priori alpha level was set to 0.05.|ANOVA|||||||0.569
72520138|NCT03418051|144569488|SUPERIORITY|||||||0.405||||||A priori threshold was 0.05.|ANOVA|||||||0.405
72520139|NCT03418051|144569488|SUPERIORITY|||||||0.229||||||A priori threshold set to 0.05.|ANOVA|||||||0.229
72520140|NCT03418051|144569489|SUPERIORITY|||||||0.609||||||A priori threshold set at 0.05.|ANOVA|||||||0.609
72520141|NCT03418051|144569489|SUPERIORITY|||||||0.027||||||A priori threshold was set at 0.05.|ANOVA|||||||0.027
72520142|NCT03418051|144569490|SUPERIORITY|||||||0.613||||||A priori alpha set at 0.05.|Independent sample Mann-Whitney U|||||||0.613
72520143|NCT03418051|144569491|SUPERIORITY|||||||0.925||||||A priori threshold set at 0.05.|Independent sample Mann-Whitney U|||||||0.925
72520144|NCT03418051|144569492|SUPERIORITY|||||||0.641||||||A priori threshold set at 0.05.|Wilcoxon (Mann-Whitney)|||||||0.641
72520145|NCT03418051|144569492|SUPERIORITY|||||||0.897||||||A priori threshold set at 0.05.|Wilcoxon (Mann-Whitney)|||||||0.897
72520146|NCT03418051|144569493|SUPERIORITY|||||||0.561||||||A priori threshold set at 0.05.|Wilcoxon (Mann-Whitney)|||||||0.561
72520147|NCT03418051|144569493|SUPERIORITY|||||||0.925||||||A priori threshold set at 0.05.|Wilcoxon (Mann-Whitney)|||||||0.925
72520148|NCT03418051|144569494|SUPERIORITY|||||||0.233||||||A priori threshold set at 0.05|ANOVA|||||||0.233
72520149|NCT03418051|144569494|SUPERIORITY|||||||0.634||||||A priori threshold set at 0.05|ANOVA|||||||0.634
72520150|NCT03418051|144569495|SUPERIORITY|||||||0.233||||||A priori threshold set at 0.05.|ANOVA|||||||0.233
72520151|NCT03418051|144569495|SUPERIORITY|||||||0.634||||||A priori threshold set at 0.05.|ANOVA|||||||0.634
72520152|NCT03418051|144569496|SUPERIORITY|||||||0.03||||||A priori threshold set at 0.05.|ANOVA|||||||0.030
72520153|NCT03418051|144569496|SUPERIORITY|||||||0.618||||||A priori threshold set at 0.05.|ANOVA|||||||0.618
72520154|NCT03418051|144569497|SUPERIORITY|||||||0.456||||||A priori threshold set at 0.05.|ANOVA|||||||0.456
72520155|NCT03418051|144569497|SUPERIORITY|||||||0.568||||||A priori threshold set to 0.05.|ANOVA|||||||0.568
72520156|NCT03418051|144569498|SUPERIORITY|||||||0.919||||||A priori alpha level was set to 0.05.|ANOVA|||||||0.919
72520157|NCT03418051|144569498|SUPERIORITY|||||||0.558||||||A priori alpha level was set to 0.05.|ANOVA|||||||0.558
72520158|NCT03418051|144569499|SUPERIORITY|||||||0.796||||||A priori alpha level was set to 0.05.|ANOVA|||||||0.796
72520159|NCT03418051|144569499|SUPERIORITY|||||||0.558||||||A priori alpha level was set to 0.05.|ANOVA|||||||0.558
72520160|NCT03418051|144569500|SUPERIORITY|||||||0.701||||||A priori alpha level was set to 0.05.|ANOVA|||||||0.701
72520161|NCT03418051|144569500|SUPERIORITY|||||||0.68||||||A priori alpha level was set to 0.05.|ANOVA|||||||0.68
72520162|NCT03418051|144569501|SUPERIORITY|||||||0.883||||||A priori threshold set at 0.05.|ANOVA|||||||0.883
72520163|NCT03418051|144569501|SUPERIORITY|||||||0.401||||||A priori threshold set at 0.05.|ANOVA|||||||0.401
72520164|NCT03418051|144569502|SUPERIORITY|||||||0.393||||||A priori threshold set at 0.05.|ANOVA|||||||0.393
72520165|NCT03418051|144569502|SUPERIORITY|||||||0.779||||||A priori threshold set at 0.05.|ANOVA|||||||0.779
72520166|NCT03418051|144569503|SUPERIORITY|||||||0.246||||||A priori threshold set at 0.05.|ANOVA|||||||0.246
72520167|NCT03418051|144569503|SUPERIORITY|||||||0.191||||||A priori threshold set at 0.05.|ANOVA|||||||0.191
72520168|NCT03418051|144569504|SUPERIORITY|||||||0.703||||||A priori threshold set at 0.05.|ANOVA|||||||0.703
72520169|NCT03418051|144569504|SUPERIORITY|||||||0.282||||||A priori threshold set at 0.05.|ANOVA|||||||0.282
72520170|NCT03418051|144569505|SUPERIORITY|||||||0.925||||||A priori alpha level was set to 0.05.|ANOVA|||||||0.925
72520171|NCT03418051|144569505|SUPERIORITY|||||||0.551||||||A priori alpha level was set to 0.05.|ANOVA|||||||0.551
72520172|NCT03418051|144569506|SUPERIORITY|||||||0.506||||||A priori threshold set at 0.05.|ANOVA|||||||0.506
72520173|NCT03418051|144569506|SUPERIORITY|||||||0.753||||||A priori threshold at 0.05.|ANOVA|||||||0.753
72520174|NCT03418051|144569507|SUPERIORITY|||||||0.777||||||A priori threshold set at 0.05.|ANOVA|||||||0.777
72520175|NCT03418051|144569507|SUPERIORITY|||||||0.475||||||A priori threshold set at 0.05.|ANOVA|||||||0.475
72520176|NCT03418051|144569508|SUPERIORITY|||||||0.738||||||A priori threshold set at 0.05.|ANOVA|||||||0.738
72520177|NCT03418051|144569508|SUPERIORITY|||||||0.042||||||A priori threshold set at 0.05.|ANOVA|||||||0.042
72569788|NCT02944383|144670005|SUPERIORITY|||||||0.2289||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.2289
72520178|NCT03418051|144569509|SUPERIORITY|||||||0.738||||||A priori threshold set at 0.05.|ANOVA|||||||0.738
72520179|NCT03418051|144569509|SUPERIORITY|||||||0.83||||||A priori threshold set at 0.05.|ANOVA|||||||0.830
72520180|NCT03418051|144569510|SUPERIORITY|||||||0.7||||||A priori threshold set at 0.05.|ANOVA|||||||0.700
72520181|NCT03418051|144569510|SUPERIORITY|||||||0.492||||||A priori threshold set at 0.05.|ANOVA|||||||0.492
72520182|NCT03418051|144569511|SUPERIORITY|||||||0.82||||||A priori threshold set at 0.05.|ANOVA|||||||0.820
72520183|NCT03418051|144569511|SUPERIORITY|||||||0.526||||||A priori threshold set at 0.05.|ANOVA|||||||0.526
72520184|NCT02193828|144569524|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANOVA|||For surface area||||<.0001
72520185|NCT02193828|144569524|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANOVA|||For surface area||||<.0001
72569789|NCT02944383|144670005|SUPERIORITY|||||||0.0416||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.0416
72520186|NCT02193828|144569524|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANOVA|||For surface area||||<.0001
72569790|NCT02944383|144670005|SUPERIORITY|||||||0.015||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.0150
72569791|NCT02944383|144670005|SUPERIORITY||Median Difference (Net)|-26.21||||0.0718|TWO_SIDED|95.0|-54.29|-1.26||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|EOS (average of week 10 and 12)||-1.26|-54.29|0.0718
72624969|NCT02757768|144779455|SUPERIORITY||LS Mean of Difference|0.92|STANDARD_ERROR_OF_MEAN|1.55||0.554|TWO_SIDED|95.0|-2.12|3.96|||ANCOVA|||Week 8 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||3.96|-2.12|0.554
72520187|NCT02193828|144569524|SUPERIORITY_OR_OTHER|||||||0.0713|TWO_SIDED||||||ANOVA|||For surface area||||.0713
72520188|NCT02193828|144569524|SUPERIORITY_OR_OTHER|||||||0.0002|TWO_SIDED||||||ANOVA|||For volume||||.0002
72520189|NCT02193828|144569524|SUPERIORITY_OR_OTHER|||||||0.0001|TWO_SIDED||||||ANOVA|||For volume||||.0001
72520190|NCT02193828|144569524|SUPERIORITY_OR_OTHER|||||||0.0001|TWO_SIDED||||||ANOVA|||For volume||||.0001
72520191|NCT02193828|144569524|SUPERIORITY_OR_OTHER|||||||0.0446|TWO_SIDED||||||ANOVA|||For volume||||.0446
72520192|NCT02193828|144569525|SUPERIORITY_OR_OTHER|||||||0.2431|TWO_SIDED||||||ANOVA|||For surface area||||.2431
72520193|NCT02193828|144569525|SUPERIORITY_OR_OTHER|||||||0.0625|TWO_SIDED||||||ANOVA|||For surface area||||.0625
72520194|NCT02193828|144569525|SUPERIORITY_OR_OTHER|||||||0.3409|TWO_SIDED||||||ANOVA|||For surface area||||.3409
72520195|NCT02193828|144569525|SUPERIORITY_OR_OTHER|||||||0.704|TWO_SIDED||||||ANOVA|||For surface area||||.7040
72520196|NCT02193828|144569525|SUPERIORITY_OR_OTHER|||||||0.3556|TWO_SIDED||||||ANOVA|||For volume||||0.3556
72520197|NCT02193828|144569525|SUPERIORITY_OR_OTHER|||||||0.1275|TWO_SIDED||||||ANOVA|||For volume||||.1275
72520198|NCT02193828|144569525|SUPERIORITY_OR_OTHER|||||||0.7883|TWO_SIDED||||||ANOVA|||For volume||||.7883
72520199|NCT02193828|144569525|SUPERIORITY_OR_OTHER|||||||0.9123|TWO_SIDED||||||ANOVA|||For volume||||.9123
72520200|NCT02193828|144569526|SUPERIORITY_OR_OTHER|||||||0.0002|TWO_SIDED||||||Kruskal-Wallis|||||||.0002
72520201|NCT02193828|144569526|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<.0001
72520202|NCT02193828|144569526|SUPERIORITY_OR_OTHER|||||||0.0002|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.0002
72520203|NCT02193828|144569526|SUPERIORITY_OR_OTHER|||||||0.0139|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.0139
72520204|NCT02193828|144569527|SUPERIORITY_OR_OTHER|||||||0.0004|TWO_SIDED||||||ANOVA|||||||.0004
72520205|NCT02193828|144569527|SUPERIORITY_OR_OTHER|||||||0.0075|TWO_SIDED||||||ANOVA|||||||.0075
72520206|NCT02193828|144569527|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANOVA|||||||<.0001
72520207|NCT02193828|144569527|SUPERIORITY_OR_OTHER|||||||0.0031|TWO_SIDED||||||ANOVA|||||||.0031
72520208|NCT02193828|144569528|SUPERIORITY_OR_OTHER|||||||0.3135|TWO_SIDED||||||ANOVA|||||||.3135
72520209|NCT02193828|144569528|SUPERIORITY_OR_OTHER|||||||0.7249|TWO_SIDED||||||ANOVA|||||||.7249
72520210|NCT02193828|144569528|SUPERIORITY_OR_OTHER|||||||0.1573|TWO_SIDED||||||ANOVA|||||||.1573
72520211|NCT02193828|144569528|SUPERIORITY_OR_OTHER|||||||0.1234|TWO_SIDED||||||ANOVA|||||||.1234
72520212|NCT02193828|144569529|SUPERIORITY_OR_OTHER|||||||0.0006|TWO_SIDED||||||Kruskal-Wallis|||||||.0006
72520213|NCT02193828|144569529|SUPERIORITY_OR_OTHER|||||||0.0014|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.0014
72520214|NCT02193828|144569529|SUPERIORITY_OR_OTHER|||||||0.0012|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.0012
72520215|NCT02193828|144569529|SUPERIORITY_OR_OTHER|||||||0.1298|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.1298
72520216|NCT02193828|144569530|SUPERIORITY_OR_OTHER|||||||0.0048|TWO_SIDED||||||Kruskal-Wallis|||||||.0048
72520217|NCT02193828|144569530|SUPERIORITY_OR_OTHER|||||||0.0034|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.0034
72520218|NCT02193828|144569530|SUPERIORITY_OR_OTHER|||||||0.0079|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.0079
72520219|NCT02193828|144569530|SUPERIORITY_OR_OTHER|||||||0.3216|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.3216
72520220|NCT02193828|144569531|SUPERIORITY_OR_OTHER|||||||0.0065|TWO_SIDED||||||Fisher Exact|||||||.0065
72520221|NCT02193828|144569531|SUPERIORITY_OR_OTHER|||||||0.0349|TWO_SIDED||||||Fisher Exact|||||||.0349
72520222|NCT02193828|144569531|SUPERIORITY_OR_OTHER|||||||0.0033|TWO_SIDED||||||Fisher Exact|||||||.0033
72569792|NCT02944383|144670005|SUPERIORITY||Median Difference (Net)|-18.68||||0.1248|TWO_SIDED|95.0|-50.0|7.31||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|EOS (average of week 10 and 12)||7.31|-50.00|0.1248
72520223|NCT02193828|144569531|SUPERIORITY_OR_OTHER|||||||0.3423|TWO_SIDED||||||Fisher Exact|||||||.3423
72520224|NCT01686958|144569549|OTHER|This is a primarily descriptive study, no statistical analysis is planned; however, analyses were performed at the alpha=0.05 level of significance and exact analyses will be used wherever possible.|||||||ONE_SIDED|95.0||||Confidence intervals \[CI\] will be constructed for outcomes of interest at the alpha=0.05 level of significance, i.e. 95% CI.||||A total of 30 subjects will be accrued to this study and treated with the PAD-105. The sample size is based primarily on feasibility and logistical concerns, however, is sufficiently large to allow the safety objectives to be met. Specifically, with 30 total patients, if no treatment-related grade 4 or 5 adverse events are observed, then a one-sided, 95% confidence interval would have an upper bound of 0.095.|For continuous outcomes, standard summary statistics will include n, mean, standard deviation, median, minimum and maximum. For categorical data, tables will show n and % of patients.|||
72520225|NCT01998880|144569565|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.46|||<|0.0001|TWO_SIDED|95.0|0.36|0.59||Type I error controlled through closed test procedure.|Log Rank, Stratified||Stratified by Binet stage at Baseline.|||0.59|0.36|<0.0001
72520226|NCT01998880|144569567|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.39|||<|0.0001|TWO_SIDED|95.0|0.31|0.5|||Log Rank, Stratified||Stratified by Binet stage at Baseline.|||0.50|0.31|<0.0001
72520227|NCT01998880|144569568|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.84||||0.2841|TWO_SIDED|95.0|0.61|1.16|||Log Rank, Stratified||Stratified by Binet stage at Baseline.|||1.16|0.61|0.2841
72520228|NCT01998880|144569569|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|34.31|||<|0.0001|TWO_SIDED|95.0|23.5|45.1|||Chi-squared|||||45.1|23.5|<0.0001
72520229|NCT01998880|144569571|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.46|||<|0.0001|TWO_SIDED|95.0|0.35|0.61|||Log-ranked, Stratified||Stratified by Binet stage at Baseline.|||0.61|0.35|<0.0001
72569793|NCT02944383|144670006|SUPERIORITY|||||||0.2397||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.2397
72569794|NCT02944383|144670006|SUPERIORITY|||||||0.5399||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.5399
72569795|NCT02944383|144670006|SUPERIORITY|||||||0.0409||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.0409
72569796|NCT02944383|144670006|SUPERIORITY|||||||0.0073||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.0073
72624970|NCT02757768|144779455|SUPERIORITY||LS Mean of Difference|1.53|STANDARD_ERROR_OF_MEAN|1.63||0.348|TWO_SIDED|95.0|-1.67|4.73|||ANCOVA|||Week 12 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||4.73|-1.67|0.348
72520230|NCT01998880|144569575|SUPERIORITY_OR_OTHER||Hazard Ratio (stratified)|0.4|||<|0.0001|TWO_SIDED|95.0|0.3|0.53|||Log Rank, Stratified||Stratified by Binet stage at Baseline.|||0.53|0.30|<0.0001
72520231|NCT01998880|144569576|SUPERIORITY_OR_OTHER||Hazard Ratio (stratified)|0.45|||<|0.0001|TWO_SIDED|95.0|0.31|0.65|||Log Rank, Stratified||Stratified by Binet stage at Baseline.|||0.65|0.31|<0.0001
72520232|NCT01998880|144569577|SUPERIORITY||Difference in Response Rates|33.04|||<|0.0001|TWO_SIDED|95.0|22.1|43.9|||Chi-squared|||Includes subjects with best overall response: CR, CRi, PR or nPR.||43.9|22.1|< 0.0001
72520233|NCT01575899|144569600|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.629|STANDARD_ERROR_OF_MEAN|3.1526||0.008|TWO_SIDED|95.0|1.28|5.42|||Chi-squared|||||5.42|1.28|0.008
72520234|NCT01575899|144569602|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.87|STANDARD_ERROR_OF_MEAN|3.2589||0.004|TWO_SIDED|95.0|1.5|10.02|||Chi-squared|||||10.02|1.5|0.004
72520235|NCT02481596|144569672|SUPERIORITY|||||||0.045||||||Beta=.083. Threshold p\<.05.|Regression, Linear|Adjusted for baseline values with cubic splines (3 knots).||3 months. Multiply imputed data (m=20) using chained equations.||||.045
72520236|NCT02481596|144569672|SUPERIORITY|||||||0.006||||||Beta=.126. Threshold p\<.05.|Regression, Linear|Adjusted for baseline values with cubic splines (3 knots).||6 months. Multiply imputed data (m=20) using chained equations.||||.006
72520237|NCT02481596|144569673|SUPERIORITY|||||||0.518||||||Beta=.031. Threshold p\<.05.|Regression, Linear|Adjusted for baseline values with cubic splines (3 knots).||3 months. Multiply imputed data (m=20) using chained equations.||||.518
72520238|NCT02481596|144569673|SUPERIORITY|||||||0.092||||||Beta=.092. Threshold p\<.05.|Regression, Linear|Adjusted for baseline values with cubic splines (3 knots).||6 months. Multiply imputed data (m=20) using chained equations.||||.092
72520239|NCT02481596|144569674|SUPERIORITY|||||||0.53||||||Beta=-.027. Threshold p\<.05|Regression, Linear|Adjusted for baseline values with cubic splines (3 knots).||3 months. Multiply imputed data (m=20) using chained equations||||.53
72520240|NCT02481596|144569674|SUPERIORITY|||||||0.41||||||Beta=-.037. Threshold p\<.05.|Regression, Linear|Adjusted for baseline values with cubic splines (3 knots).||6 months. Multiply imputed data (m=20) using chained equations.||||.41
72520241|NCT02481596|144569675|SUPERIORITY|||||||0.024||||||Beta=.088. Threshold p\<.05.|Regression, Linear|Adjusted for baseline values with cubic splines (3 knots); also adjusted for harmful involvement subscale of FIAD due to suppression effect.||3 months. Multiply imputed data (m=20) using chained equations.||||.024
72520242|NCT02481596|144569675|SUPERIORITY|||||||0.003||||||Beta=.128. Threshold p\<.05|Regression, Linear|Adjusted for baseline values with cubic splines (3 knots); also adjusted for harmful involvement subscale of FIAD due to suppression effect.||6 months. Multiply imputed data (m=20) using chained equations.||||.003
72569797|NCT02944383|144670006|SUPERIORITY|||||||0.0976||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||EOS (average of week 10 and 12)||||0.0976
72520243|NCT02481596|144569676|SUPERIORITY|||||||0.001||||||Beta=-.133. Threshold p\<.05.|Regression, Linear|Adjusted for baseline values with cubic splines (3 knots); also adjusted for helpful involvement subscale of FIAD due to suppression effect.||3 months. Multiply imputed data (m=20) using chained equations.||||.001
72520244|NCT02481596|144569676|SUPERIORITY|||||||0.012||||||Beta=-.115. Threshold p\<.05.|Regression, Linear|Adjusted for baseline values with cubic splines (3 knots); also adjusted for helpful involvement subscale of FIAD due to suppression effect.||6 months. Multiply imputed data (m=20) using chained equations.||||.012
72520245|NCT02481596|144569677|SUPERIORITY|||||||0.015||||||Beta=.114. Threshold p\<.05.|Regression, Linear|Adjusted for baseline values with cubic splines (3 knots).||3 months. Multiply imputed data (m=20) using chained equations.||||.015
72520246|NCT02481596|144569677|SUPERIORITY|||||||0.034||||||Beta=.101. Threshold p\<.05.|Regression, Linear|Adjusted for baseline values with cubic splines (3 knots).||6 months. Multiply imputed data (m=20) using chained equations.||||.034
72520247|NCT03205982|144569693|EQUIVALENCE|If the difference (between treatment and control arm) is greater than the minimal clinically important difference (MCID), we consider the treatment arm is different from the control arm. MCID is calculated as 0.25-0.5\* standard deviation (SD). Conversely, the equivalence margin is the biggest difference (between 2 arms) to be considered no difference between 2 arms. Therefore, the equivalence margin should be smaller than MCID, i.e., it should be smaller than the smallest possible MCID.|Odds Ratio (OR)|0.9943|STANDARD_ERROR_OF_MEAN|0.0005|<|0.0001|TWO_SIDED|95.0|0.993|0.995|||Mixed Models Analysis|generalized linear mixed model with logit link (logistic model)||Compares difference in adherence changes between Intervention and Control arms||0.995|0.993|<0.0001
72520248|NCT00631540|144569716|SUPERIORITY_OR_OTHER||Mean Patency Rate|91.7|||<|0.0001|TWO_SIDED|95.0|84.2|95.9|||Z-test, 1-sided||GEE model estimate.|Alternative hypothesis is 9-month primary patency rate greater than 60%.||95.9|84.2|<0.0001
72520249|NCT01135394|144569737|OTHER|The genes with p-values below 10\^-6 were identified|Pearson correlation p-value|0.0000001|||<|1e-07|TWO_SIDED|||||The genes with p-values below 10\^-6 were identified|Genes with p-values below 10^-6|||After the change (end-of-treatment minus baseline) in HOMA-IR index had been calculated for each subject, the change (end-of-treatment minus baseline) in expression of each of approximately 45,000 transcripts contained in a human gene array was calculated. A Pearson correlation p-value was calculated for the correlation between change in gene expression and change in HOMA-IR index, with the purpose of identifying the genes whose expression changed in concert with changes in HOMA-IR index.|The genes with P-values below 10\^-6 were identified|||<0.0000001
72520250|NCT00191386|144569740|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-Value for Total Score 6 Months|Paired t-test|||||||<0.001
72405802|NCT02659020|144320136|SUPERIORITY||Odds Ratio (OR)|1.106||||0.7724|TWO_SIDED|95.0|0.558|2.194||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|Exact Mantel-Haenszel test||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|||2.194|0.558|0.7724
72520251|NCT00191386|144569740|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-Value for Total Score 12 Months|Paired t-test|||||||<0.001
72520252|NCT00191386|144569740|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-Value for Total Score 2 Years.|Paired t-test|||||||<0.001
72520253|NCT00191386|144569740|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-Value for Total Score 3 Years.|Paired t-test|||||||<0.001
72624971|NCT02757768|144779455|SUPERIORITY||LS Mean of Difference|0.25|STANDARD_ERROR_OF_MEAN|1.6||0.876|TWO_SIDED|95.0|-2.89|3.38|||ANCOVA|||EoT Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||3.38|-2.89|0.876
72520254|NCT00191386|144569740|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-Value for Total Score 4 Years.|Paired t-test|||||||<0.001
72520255|NCT00191386|144569741|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-Value for 6 Months.|Paired t-test|||||||<0.001
72520256|NCT00191386|144569741|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-Value for 12 Months.|Paired t-test|||||||<0.001
72520257|NCT00191386|144569741|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-Value for 2 Years.|Paired t-test|||||||<0.001
72520258|NCT00191386|144569741|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-Value for 3 Years.|Paired t-test|||||||<0.001
72520259|NCT00191386|144569741|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-Value for 4 Years.|Paired t-test|||||||<0.001
72520260|NCT00439725|144569749|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.185|STANDARD_ERROR_OF_MEAN|0.3858|<|0.0001||95.0|0.087|0.393||1st test in a hierarchy, a p-value of less than 0.05 would be considered significant.|Regression, Cox|Stratified by intended treatment duration, adjusted for pre-treatment||The rivaroxaban to comparator hazard ratio was computed with a 95% CI (confidence interval) (two-sided testing).||0.393|0.087|< 0.0001
72520261|NCT00439725|144569750|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.18|STANDARD_ERROR_OF_MEAN|0.385|<|0.0001||95.0|0.085|0.383||2nd test in a hierarchy, a p-value of less than 0.05 would be considered significant. If the 1st test in hierarchy was significant.|Regression, Cox|Stratified by intended treatment duration, adjusted for pre-treatment||The rivaroxaban to comparator hazard ratio was computed with a 95% CI (two-sided testing).||0.383|0.085|< 0.0001
72520262|NCT00439725|144569751|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.198|STANDARD_ERROR_OF_MEAN|0.3659|<|0.0001||95.0|0.096|0.405||3rd test in a hierarchy, a p-value of less than 0.05 would be considered significant. If the previous tests in hierarchy were significant|Regression, Cox|Stratified by intended treatment duration, adjusted for pre-treatment||The rivaroxaban to comparator hazard ratio was computed with a 95% CI (two-sided testing).||0.405|0.096|< 0.0001
72520263|NCT00439725|144569752|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.278|STANDARD_ERROR_OF_MEAN|0.3274|<|0.0001||95.0|0.146|0.528||4th test in a hierarchy, a p-value of less than 0.05 would be considered significant. If the previous tests in hierarchy were significant|Regression, Cox|Stratified by intended treatment duration, adjusted for pre-treatment||The rivaroxaban to comparator hazard ratio was computed with a 95% CI (two-sided testing).||0.528|0.146|< 0.0001
72520264|NCT00439725|144569755|SUPERIORITY_OR_OTHER|||||||0.1121||||||No adjustment for multiple comparison.|Log Rank|||The rivaroxaban to comparator hazard ratio was computed with a 95% CI (two-sided testing), comparison was done for the treatment emergent (within two days after end of treatment) bleeding events.||||0.1121
72520265|NCT00439725|144569756|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|5.185|STANDARD_ERROR_OF_MEAN|0.4131|<|0.0001||95.0|2.307|11.652||No adjustment for multiple comparison, a p-value of less than 0.05 would be considered significant.|Regression, Cox|Stratified by intended treatment duration, adjusted for pre-treatment done for treatment-emergent (time window: 2 days)||The rivaroxaban to comparator hazard ratio was computed with a 95% CI (two-sided testing), comparison was done for the treatment emergent (within two days after end of treatment) bleeding events.||11.652|2.307|< 0.0001
72520266|NCT01673490|144569789|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||||||<0.001
72520267|NCT01673490|144569790|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||for Month 3|t-test, 2 sided|||||||<0.001
72520268|NCT01673490|144569790|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||for Month 6|t-test, 2 sided|||||||<0.001
72520269|NCT00379236|144569792|SUPERIORITY_OR_OTHER|||||||0.008||95.0|||||ANCOVA|Screening pain score was the covariate; study center was modeled as a random effect while all other variables were modeled as fixed effects.||||||0.008
72520270|NCT00379236|144569793|SUPERIORITY_OR_OTHER|||||||0.001||95.0||||P-value is purely nominal|ANCOVA|||||||0.001
72520271|NCT00379236|144569794|SUPERIORITY_OR_OTHER|||||||0.202||95.0|||||Chi-squared|||||||0.202
72520272|NCT00379236|144569795|SUPERIORITY_OR_OTHER|||||||0.047||95.0|||||Chi-squared|||||||0.047
72520273|NCT00379236|144569796|SUPERIORITY_OR_OTHER|||||||0.618||95.0|||||Chi-squared|||||||0.618
72520274|NCT00379236|144569797|SUPERIORITY_OR_OTHER|||||||0.028||95.0|||||Chi-squared|||||||0.028
72569798|NCT02944383|144670006|SUPERIORITY|||||||0.1899||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||EOS (average of week 10 and 12)||||0.1899
72520275|NCT00379236|144569798|SUPERIORITY_OR_OTHER|||||||0.002|||||||ANCOVA|Baseline pain score was the covariate; study center was modeled as a random effect while all other variables were modeled as fixed effects.||||||0.002
72520276|NCT00379236|144569809|SUPERIORITY_OR_OTHER|||||||0.006||95.0|||||Chi-squared|||||||0.006
72520277|NCT02940860|144569819|NON_INFERIORITY|Non-inferiority could be claimed if the lower bound of the 95% confidence interval (CI) was above -0.5 g/dL.|Mean Difference (Final Values)|0.08|||||TWO_SIDED|95.0|-0.06|0.23|||||The Mixed Model for Repeated Measurement (MMRM) used for testing, included the fixed, categorical effects of treatment, week, treatment-by-week interaction, strata, and the continuous covariates of baseline Hb and baseline Hb-by-week interaction.|"Power:~With N=1000 subjects in the iron isomaltoside/ferric derisomaltose treatment group and with N=500 subjects in the iron sucrose treatment group, assuming no difference between the treatment groups and assuming a common standard deviation (SD) of 1.5 g/dL, the power was 100% for demonstrating non-inferiority of the change in Hb from baseline to week 8, using a non-inferiority margin of -0.5 g/dL.~The significance level was set to 5%."||0.23|-0.06|
72520278|NCT02940860|144569820|OTHER||95% two-sided CI (iron isomaltoside)|0.3|||||TWO_SIDED|95.0|0.06|0.86||||||"Power:~With N=1000 subjects in the iron isomaltoside/ferric derisomaltose, the power was 88% to demonstrate that the upper bound of the 95% CI of the incidence of treatment-emergent serious and/or severe non-serious hypersensitivity AEs was less than 3%.~The significance level was set to 5%."||0.86|0.06|
72520279|NCT02940860|144569820|OTHER||Risk Difference (RD)|0.29|||||TWO_SIDED|95.0|-0.19|0.77||||||Risk difference between iron isomaltoside/ferric derisomaltose and iron sucrose was assessed for the individual trial with 95% Newcombe CI adjusted for stratum using the Cochran-Mantel-Haenszel method.||0.77|-0.19|
72520280|NCT02940860|144569820|NON_INFERIORITY|Non-inferiority can be claimed if the upper bound of the 95% CI is below 1.5 % point.|Risk Difference (RD)|0.1|||||TWO_SIDED|95.0|-0.57|0.48||||||Risk difference between iron isomaltoside/ferric derisomaltose and iron sucrose was assessed for the pooled FERWON-IDA and FERWON-NEPHRO trials (2008 subjects treated with iron isomaltoside/ferric derisomaltose and 1000 subjects treated with iron sucrose) with 95% Newcombe CI adjusted for stratum using the Cochran-Mantel-Haenszel method.||0.48|-0.57|
72520281|NCT02940860|144569821|SUPERIORITY|||||||0.0248|||||||Fisher Exact|||Adjudicated and confirmed treatment-emergent composite cardiovascular AEs. Any treatment emergent composite cardiovascular AEs were included in the statistical evaluation. The overall incidence of adjudicated and confirmed composite cardiovascular AEs was tabulated and compared between the treatment groups by a Fisher's exact test.||||0.0248
72520282|NCT02940860|144569822|SUPERIORITY|||||||0.0185|||||||Log Rank|||The time to first adjudicated and confirmed composite cardiovascular AEs was estimated using the Kaplan-Meier method and the hypothesis of no treatment difference was assessed by a log-rank test.||||0.0185
72520283|NCT02940860|144569824|SUPERIORITY||Odds Ratio (OR)|1.37||||0.0478|TWO_SIDED|95.0|1.0|1.87|||Repeated measures logistic regressioin|||"Week 1~Hb increase of ≥1 g/dL from baseline to week 1.~Proportion of Hb responders to each week was analysed using a repeated measures logistic regression model with treatment, visit, strata, and treatment by visit interaction as fixed effects and baseline value as covariate."||1.87|1.00|0.0478
72520284|NCT02940860|144569824|SUPERIORITY||Odds Ratio (OR)|1.81|||<|0.0001|TWO_SIDED|95.0|1.39|2.36|||Repeated measures logistic regressioin|||"Week 2~Hb increase of ≥1 g/dL from baseline to week 2.~Proportion of Hb responders to each week was analysed using a repeated measures logistic regression model with treatment, visit, strata, and treatment by visit interaction as fixed effects and baseline value as covariate."||2.36|1.39|<0.0001
72520285|NCT02940860|144569824|SUPERIORITY||Odds Ratio (OR)|1.41||||0.0048|TWO_SIDED|95.0|1.11|1.79|||Repeated measures logistic regressioin|||"Week 4~Hb increase of ≥1 g/dL from baseline to week 4.~Proportion of Hb responders to each week was analysed using a repeated measures logistic regression model with treatment, visit, strata, and treatment by visit interaction as fixed effects and baseline value as covariate."||1.79|1.11|0.0048
72520286|NCT02940860|144569824|SUPERIORITY||Odds Ratio (OR)|1.01||||0.944|TWO_SIDED|95.0|0.8|1.27|||Repeated measures logistic regressioin|||"Week 8~Hb increase of ≥1 g/dL from baseline to week 8.~Proportion of Hb responders to each week was analysed using a repeated measures logistic regression model with treatment, visit, strata, and treatment by visit interaction as fixed effects and baseline value as covariate."||1.27|0.80|0.9440
72569799|NCT02944383|144670007|SUPERIORITY|||||||0.1747||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.1747
72520287|NCT02940860|144569825|SUPERIORITY|||||||0.0174|||||||Log Rank|||Time to Hb response was estimated using the Kaplan-Meier method and the hypothesis of no treatment difference was assessed by a 2-sided log-rank test.||||0.0174
72405803|NCT02659020|144320136|SUPERIORITY||Odds Ratio (OR)|1.222||||0.6508|TWO_SIDED|95.0|0.513|2.911||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|Exact Mantel-Haenszel test||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|||2.911|0.513|0.6508
72405804|NCT02659020|144320137|SUPERIORITY||Hazard Ratio (HR)|0.661||||0.073|TWO_SIDED|95.0|0.419|1.041||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|Log Rank||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|||1.041|0.419|0.073
72405805|NCT02659020|144320137|SUPERIORITY||Hazard Ratio (HR)|0.703||||0.225|TWO_SIDED|95.0|0.395|1.253||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|Log Rank||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|||1.253|0.395|0.225
72405806|NCT02659020|144320138|SUPERIORITY||Hazard Ratio (HR)|1.213||||0.332|TWO_SIDED|95.0|0.834|1.764||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|Log Rank||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|Fatigue||1.764|0.834|0.332
72520288|NCT02940860|144569826|SUPERIORITY||Odds Ratio (OR)|1.1||||0.5074|TWO_SIDED|95.0|0.83|1.45|||Regression, Logistic|||The proportion of subjects who achieved a Hb level of \>12 g/dL at any time from week 1 to week 8 was analysed using a logistic regression model with treatment and strata as fixed effects. The estimated treatment ratio of iron isomaltoside/ferric derisomaltose versus iron sucrose is presented with 95% CI and corresponding p-value.||1.45|0.83|0.5074
72520289|NCT02940860|144569827|SUPERIORITY||Odds Ratio (OR)|1.24||||0.1035|TWO_SIDED|95.0|0.96|1.6|||Regression, Logistic|||"The proportion of subjects who achieved an increase in Hb concentration ≥2 g/dL at any time from week 1 to week 8 was analysed using a logistic regression model with treatment and strata as fixed effects.~The estimated treatment ratio of iron isomaltoside/ferric derisomaltose versus iron sucrose was presented with 95% CI and corresponding p-value."||1.60|0.96|0.1035
72520290|NCT02940860|144569828|SUPERIORITY||Odds Ratio (OR)|1.82|||<|0.0001|TWO_SIDED|95.0|1.38|2.4|||Regression, Logistic|||"Proportion of subject who achieved a s-ferritin level of ≥100 ng/mL AND a TSAT of 20-50% at any time from week 1 to week 8 was analysed using a logistic regression model with treatment and strata as fixed effects.~The estimated treatment ratio of iron isomaltoside/ferric derisomaltose versus iron sucrose is presented with 95% CI and corresponding p-value."||2.40|1.38|<0.0001
72520291|NCT02940860|144569829|SUPERIORITY||Mean Difference (Final Values)|0.22|||<|0.0001|TWO_SIDED|95.0|0.12|0.31|||Mixed model for repeated measures|||"Week 1~Change in Hb concentration from baseline to week 1 was analysed using a MMRM including treatment, week, treatment-by-week interaction, and strata as factors and baseline value and baseline value-by-week interaction as covariates."||0.31|0.12|<0.0001
72520292|NCT02940860|144569829|SUPERIORITY||Mean Difference (Final Values)|0.25|||<|0.0001|TWO_SIDED|95.0|0.14|0.36|||Mixed model for repeated measures|||"Week 2~Change in Hb concentration from baseline to week 2 was analysed using a MMRM including treatment, week, treatment-by-week interaction, and strata as factors and baseline value and baseline value-by-week interaction as covariates."||0.36|0.14|<0.0001
72520293|NCT02940860|144569829|SUPERIORITY||Mean Difference (Final Values)|0.15||||0.0208|TWO_SIDED|95.0|0.02|0.28|||Mixed model for repeated measures|||"Week 4~Change in Hb concentration from baseline to week 4 was analysed using a MMRM including treatment, week, treatment-by-week interaction, and strata as factors and baseline value and baseline value-by-week interaction as covariates."||0.28|0.02|0.0208
72520294|NCT02940860|144569830|SUPERIORITY||Mean Difference (Final Values)|309.2|||<|0.0001|TWO_SIDED|95.0|280.7|337.8|||Mixed model for repeated measures|||"Week 1~Change in concentrations of s-ferritin from baseline to week 1 was analysed using a MMRM including treatment, week, treatment-by-week interaction, and strata as factors and baseline value and baseline value-by-week interaction as covariates.~The estimated treatment differences based on the least square means of the treatment by-week interaction effects are presented by week, include 95% CIs and corresponding p-value."||337.8|280.7|<0.0001
72520295|NCT02940860|144569830|SUPERIORITY||Mean Difference (Final Values)|95.8|||<|0.0001|TWO_SIDED|95.0|67.9|123.7|||Mixed model for repeated measures|||"Week 2~Change in concentrations of s-ferritin from baseline to week 2 was analysed using MMRM including treatment, week, treatment-by-week interaction, and strata as factors and baseline value and baseline value-by-week interaction as covariates.~The estimated treatment differences based on the least square means of the treatment by-week interaction effects are presented by week, include 95% CIs and corresponding p-value."||123.7|67.9|<0.0001
72520296|NCT02940860|144569830|SUPERIORITY||Mean Difference (Final Values)|3.5||||0.7834|TWO_SIDED|95.0|-21.2|28.1|||Mixed model for repeated measures|||"Week 4~Change in concentrations of s-ferritin from baseline to week 4 was analysed using MMRM including treatment, week, treatment-by-week interaction, and strata as factors and baseline value and baseline value-by-week interaction as covariates.~The estimated treatment differences based on the least square means of the treatment by-week interaction effects are presented by week, include 95% CIs and corresponding p-value."||28.1|-21.2|0.7834
72569800|NCT02944383|144670007|SUPERIORITY|||||||0.4576||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.4576
72569801|NCT02944383|144670007|SUPERIORITY|||||||0.1549||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.1549
72520297|NCT02940860|144569830|SUPERIORITY||Mean Difference (Final Values)|3.3||||0.7621|TWO_SIDED|95.0|-18.1|24.7|||Mixed model for repeated measures|||"Week 8~Change in concentrations of s-ferritin from baseline to week 8 was analysed using MMRM including treatment, week, treatment-by-week interaction, and strata as factors and baseline value and baseline value-by-week interaction as covariates.~The estimated treatment differences based on the least square means of the treatment by-week interaction effects are presented by week, include 95% CIs and corresponding p-value."||24.7|-18.1|0.7621
72520298|NCT02940860|144569831|SUPERIORITY||Mean Difference (Final Values)|8.8|||<|0.0001|TWO_SIDED|95.0|6.9|10.7|||Mixed model for repeated measures|||"Week 1~Change in TSAT from baseline to week 1 was analysed using MMRM including treatment, week, treatment-by-week interaction, and strata as factors and baseline value and baseline value-by-week interaction as covariates.~The estimated treatment differences based on the least square means of the treatment by-week interaction effects are presented by week, include 95% CIs and corresponding p-value."||10.7|6.9|<0.0001
72520299|NCT02940860|144569831|SUPERIORITY||Mean Difference (Final Values)|1.3||||0.0129|TWO_SIDED|95.0|0.3|2.4|||Mixed model for repeated measures|||"Week 2~Change in TSAT from baseline to week 2 was analysed using MMRM including treatment, week, treatment-by-week interaction, and strata as factors and baseline value and baseline value-by-week interaction as covariates.~The estimated treatment differences based on the least square means of the treatment by-week interaction effects are presented by week, include 95% CIs and corresponding p-value."||2.4|0.3|0.0129
72520300|NCT02940860|144569831|SUPERIORITY||Mean Difference (Final Values)|0.5||||0.2403|TWO_SIDED|95.0|-0.4|1.5|||Mixed model for repeated measures|||"Week 4~Change in TSAT from baseline to week 4 was analysed using MMRM including treatment, week, treatment-by-week interaction, and strata as factors and baseline value and baseline value-by-week interaction as covariates.~The estimated treatment differences based on the least square means of the treatment by-week interaction effects are presented by week, include 95% CIs and corresponding p-value."||1.5|-0.4|0.2403
72520301|NCT02940860|144569831|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.8094|TWO_SIDED|95.0|-0.9|1.2|||Mixed model for repeated measures|||"Week 8~Change in TSAT from baseline to week 8 was analysed using MMRM including treatment, week, treatment-by-week interaction, and strata as factors and baseline value and baseline value-by-week interaction as covariates.~The estimated treatment differences based on the least square means of the treatment by-week interaction effects are presented by week, include 95% CIs and corresponding p-value."||1.2|-0.9|0.8094
72520302|NCT02940860|144569832|SUPERIORITY||Mean Difference (Final Values)|26.5|||<|0.0001|TWO_SIDED|95.0|20.4|32.7|||Mixed model for repeated measures|||"Week 1~Change in s-iron from baseline to week 1 was analysed using a Mixed Model for Repeated Measurement (MMRM) including treatment, week, treatment-by-week interaction, and strata as factors and baseline value and baseline value-by-week interaction as covariates.~The estimated treatment differences based on the least square means of the treatment-by week interaction effects are presented by week, including 95% CIs and corresponding p-value."||32.7|20.4|<0.0001
72520303|NCT02940860|144569832|SUPERIORITY||Mean Difference (Final Values)|1.9||||0.2229|TWO_SIDED|95.0|-1.2|5.1|||Mixed model for repeated measures|||"Week 2~Change in s-iron from baseline to week 2 was analysed using a Mixed Model for Repeated Measurement (MMRM) including treatment, week, treatment-by-week interaction, and strata as factors and baseline value and baseline value-by-week interaction as covariates.~The estimated treatment differences based on the least square means of the treatment-by week interaction effects are presented by week, including 95% CIs and corresponding p-value."||5.1|-1.2|0.2229
72520304|NCT02940860|144569832|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.9046|TWO_SIDED|95.0|-2.9|2.6|||Mixed model for repeated measures|||"Week 4~Change in s-iron from baseline to week 4 was analysed using a Mixed Model for Repeated Measurement (MMRM) including treatment, week, treatment-by-week interaction, and strata as factors and baseline value and baseline value-by-week interaction as covariates.~The estimated treatment differences based on the least square means of the treatment-by week interaction effects are presented by week, including 95% CIs and corresponding p-value."||2.6|-2.9|0.9046
72520305|NCT02940860|144569832|SUPERIORITY||Mean Difference (Final Values)|-2.5||||0.1307|TWO_SIDED|95.0|-5.8|0.8|||Mixed model for repeated measures|||"Week 8~Change in s-iron from baseline to week 8 was analysed using a Mixed Model for Repeated Measurement (MMRM) including treatment, week, treatment-by-week interaction, and strata as factors and baseline value and baseline value-by-week interaction as covariates.~The estimated treatment differences based on the least square means of the treatment-by week interaction effects are presented by week, including 95% CIs and corresponding p-value."||0.8|-5.8|0.1307
72520306|NCT02940860|144569833|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.8196|TWO_SIDED|95.0|-0.73|0.92|||Mixed model for repeated measures|||"Week 1~Change in fatigue symptoms score from baseline to week 1 was analysed using MMRM including treatment, week, treatment-by-week interaction, and strata as factors and baseline score and baseline score-by-week interaction as covariates."||0.92|-0.73|0.8196
72520307|NCT02940860|144569833|SUPERIORITY||Mean Difference (Final Values)|-0.17||||0.7132|TWO_SIDED|95.0|-1.06|0.73|||Mixed model for repeated measures|||"Week 2~Change in fatigue symptoms score from baseline to week 2 was analysed using MMRM including treatment, week, treatment-by-week interaction, and strata as factors and baseline score and baseline score-by-week interaction as covariates."||0.73|-1.06|0.7132
72520308|NCT02940860|144569833|SUPERIORITY||Mean Difference (Final Values)|0.27||||0.586|TWO_SIDED|95.0|-0.71|1.25|||Mixed model for repeated measures|||"Week 8~Change in fatigue symptoms score from baseline to week 8 was analysed using MMRM including treatment, week, treatment-by-week interaction, and strata as factors and baseline score and baseline score-by-week interaction as covariates."||1.25|-0.71|0.5860
72569802|NCT02944383|144670007|SUPERIORITY|||||||0.2427||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.2427
72520309|NCT04914819|144569839|SUPERIORITY||Mean Difference (Final Values)|5.3||||0.048|TWO_SIDED|95.0|0.04|10.8|||Mixed Models Analysis|||Change in weight among participants who completed final assessment||10.8|0.04|0.048
72520310|NCT04914819|144569840|SUPERIORITY|||||||0.3|||||||Chi-squared|||||||0.3
72520311|NCT04914819|144569841|SUPERIORITY|||||||0.331|||||||Chi-squared|||||||0.331
72520312|NCT04914819|144569842|SUPERIORITY|||||||0.734|||||||Fisher Exact|||||||0.734
72520313|NCT04038385|144569854|SUPERIORITY||Mean Difference (Net)|-42.87||||0.001|TWO_SIDED|95.0|-65.25|-20.49|||Mixed Models Analysis|||||-20.49|-65.25|0.001
72405807|NCT02659020|144320138|SUPERIORITY||Hazard Ratio (HR)|0.813||||0.389|TWO_SIDED|95.0|0.514|1.287||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|Log Rank||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|Nausea and vomiting||1.287|0.514|0.389
72520314|NCT04038385|144569855|SUPERIORITY||Median Difference (Net)|23.91||||0.031|TWO_SIDED|95.0|2.21|45.62|||Mixed Models Analysis|||||45.62|2.21|0.031
72569803|NCT02944383|144670007|SUPERIORITY||Median Difference (Net)|1.51||||0.1379|TWO_SIDED|95.0|-6.26|8.73||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|EOS (average of week 10 and 12)||8.73|-6.26|0.1379
72569804|NCT02944383|144670007|SUPERIORITY||Median Difference (Net)|-6.02||||0.249|TWO_SIDED|95.0|-13.1|0.51||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|EOS (average of week 10 and 12)||0.51|-13.10|0.2490
72405808|NCT02659020|144320138|SUPERIORITY||Hazard Ratio (HR)|0.598||||0.02|TWO_SIDED|95.0|0.386|0.926||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|Log Rank||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|Pain||0.926|0.386|0.020
72520315|NCT04038385|144569856|SUPERIORITY||Median Difference (Net)|-0.06||||0.662|TWO_SIDED|95.0|-0.33|0.21|||Mixed Models Analysis|||||0.21|-0.33|0.662
72520316|NCT04038385|144569857|SUPERIORITY||Mean Difference (Net)|0.28||||0.047|TWO_SIDED|95.0|0.0|0.55|||Mixed Models Analysis|||||0.55|0.00|0.047
72520317|NCT04038385|144569858|SUPERIORITY||Odds Ratio (OR)|17.39|||<|0.01|TWO_SIDED|95.0|8.64|35.02|||Regression, Logistic|||||35.02|8.64|<0.01
72520318|NCT04038385|144569859|SUPERIORITY||Odds Ratio (OR)|3.9||||0.056|TWO_SIDED|95.0|1.0|16.1|||Mixed Models Analysis|||||16.1|1.0|0.056
72520319|NCT04038385|144569860|SUPERIORITY||Odds Ratio (OR)|4.0||||0.05|TWO_SIDED|95.0|1.0|16.3|||Mixed Models Analysis|||||16.3|1.0|0.050
72520320|NCT04038385|144569861|SUPERIORITY||Mean Difference (Net)|-1.7||||0.001|TWO_SIDED|95.0|-2.5|-1.0|||Mixed Models Analysis|||||-1.0|-2.5|0.001
72520321|NCT04038385|144569862|SUPERIORITY||Median Difference (Net)|-0.7||||0.082|TWO_SIDED|95.0|-1.4|0.1|||Mixed Models Analysis|||||0.1|-1.4|0.082
72520322|NCT04038385|144569863|SUPERIORITY||Mean Difference (Net)|-1.5||||0.001|TWO_SIDED|95.0|-2.2|-0.8|||Mixed Models Analysis|||||-0.8|-2.2|0.001
72520323|NCT04038385|144569864|SUPERIORITY||Median Difference (Net)|-0.7||||0.039|TWO_SIDED|95.0|-1.4|0.0|||Mixed Models Analysis|||||-0.0|-1.4|0.039
72520324|NCT04038385|144569865|SUPERIORITY||Mean Difference (Net)|0.0||||0.962|TWO_SIDED|95.0|-0.3|0.3|||Mixed Models Analysis|||||0.3|-0.3|0.962
72520325|NCT04038385|144569866|SUPERIORITY||Mean Difference (Net)|-0.2||||0.277|TWO_SIDED|95.0|-0.4|0.1|||Mixed Models Analysis|||||0.1|-0.4|.277
72520326|NCT04038385|144569867|SUPERIORITY||Median Difference (Net)|-0.4||||0.155|TWO_SIDED|95.0|-1.0|0.2|||Mixed Models Analysis|||||0.2|-1.0|0.155
72520327|NCT04038385|144569868|SUPERIORITY||Mean Difference (Net)|0.1||||0.74|TWO_SIDED|95.0|-0.5|0.7|||Mixed Models Analysis|||||0.7|-0.5|0.740
72520328|NCT04038385|144569869|SUPERIORITY||Median Difference (Net)|-0.2||||0.122|TWO_SIDED|95.0|-0.5|0.1|||Mixed Models Analysis|||||0.1|-0.5|.122
72520329|NCT04038385|144569870|SUPERIORITY||Mean Difference (Net)|-0.2||||0.177|TWO_SIDED|95.0|-0.5|0.1|||Mixed Models Analysis|||||0.1|-0.5|.177
72520330|NCT04038385|144569871|SUPERIORITY||Median Difference (Net)|0.1||||0.514|TWO_SIDED|95.0|-0.3|0.5|||Mixed Models Analysis|||||0.5|-0.3|0.514
72520331|NCT04038385|144569872|SUPERIORITY||Median Difference (Net)|0.2||||0.335|TWO_SIDED|95.0|-0.2|0.6|||Mixed Models Analysis|||||0.6|-0.2|0.335
72520332|NCT04038385|144569873|SUPERIORITY||Mean Difference (Net)|0.1||||0.75|TWO_SIDED|95.0|-0.4|0.6|||Mixed Models Analysis|||||0.6|-0.4|0.750
72520333|NCT04038385|144569874|SUPERIORITY||Mean Difference (Net)|-0.2||||0.455|TWO_SIDED|95.0|-0.7|0.3|||Mixed Models Analysis|||||0.3|-0.7|0.455
72520334|NCT04038385|144569875|SUPERIORITY||Mean Difference (Net)|0.9||||0.053|TWO_SIDED|95.0|0.0|1.8|||Mixed Models Analysis|||||1.8|-0.0|0.053
72520335|NCT04038385|144569876|SUPERIORITY||Mean Difference (Net)|0.0||||0.986|TWO_SIDED|95.0|-0.9|0.9|||Mixed Models Analysis|||||0.9|-0.9|.986
72520336|NCT04038385|144569877|SUPERIORITY||Odds Ratio (OR)|1.1||||0.81|TWO_SIDED|95.0|0.6|2.2|||Mixed Models Analysis|||||2.2|0.6|0.810
72520337|NCT04038385|144569878|SUPERIORITY||Odds Ratio (OR)|0.8||||0.591|TWO_SIDED|95.0|0.4|1.7|||Mixed Models Analysis|||||1.7|0.4|0.591
72520338|NCT03961295|144569882|OTHER||Ratio of Geometric LSMs|1.2984|||||TWO_SIDED|90.0|1.0786|1.5486||||||Geometric least-squares means (LSMs) were calculated by exponentiating the LSMs derived from analysis of variance (ANCOVA) with weight as a covariate. Confidence intervals (CIs) were calculated using treatment standard errors from the ANCOVA model and t-statistic for error degrees of freedom.||1.5486|1.0786|
72520339|NCT03961295|144569883|OTHER||Ratio of Geometric LSMs|1.3274|||||TWO_SIDED|90.0|1.1147|1.5807||||||Geometric LSMs were calculated by exponentiating the LSMs derived from ANCOVA with weight as a covariate. CIs were calculated using treatment standard errors from the ANCOVA model and t-statistic for error degrees of freedom.||1.5807|1.1147|
72520340|NCT03961295|144569884|OTHER||Ratio of Geometric LSMs|1.1978|||||TWO_SIDED|90.0|1.0394|1.3804||||||Geometric LSMs were calculated by exponentiating the LSMs derived from ANCOVA with weight as a covariate. CIs were calculated using treatment standard errors from the ANCOVA model and t-statistic for error degrees of freedom.||1.3804|1.0394|
72569805|NCT02944383|144670008|SUPERIORITY|||||||0.155||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.1550
72520341|NCT03170258|144569918|OTHER|||||||0.0015|||||||t-test, 2 sided|One-sample 2-sided t-test against a mean of 0 used to evaluate the main effect of VTA activation during neurofeedback.||||||0.0015
72520342|NCT03170258|144569919|OTHER||||||>|0.1|||||||t-test, 1 sided|One-sample t-test against 0 for the ratio of Beta to Theta power.||||||>0.10
72520343|NCT00810043|144569964|SUPERIORITY_OR_OTHER|||||||0.43|||||||t-test, 2 sided|||Anterior vertebral body height restoration as a percent (Post-procedure change from baseline)||||0.430
72520344|NCT00810043|144569964|SUPERIORITY_OR_OTHER|||||||0.643|||||||t-test, 2 sided|||Middle vertebral body height restoration as a percent (Post-procedure change from baseline)||||0.643
72520345|NCT00810043|144569964|SUPERIORITY_OR_OTHER|||||||0.165|||||||t-test, 2 sided|||Posterior vertebral body height restoration as a percent (Post-procedure change from baseline)||||0.165
72520346|NCT00810043|144569965|SUPERIORITY_OR_OTHER|||||||0.402|||||||t-test, 2 sided|||Anterior VBH restored||||0.402
72520347|NCT00810043|144569965|SUPERIORITY_OR_OTHER|||||||0.578|||||||t-test, 2 sided|||Middle VBH restored||||0.578
72520348|NCT00810043|144569965|SUPERIORITY_OR_OTHER|||||||0.166|||||||t-test, 2 sided|||Posterior VBH restored||||0.166
72520349|NCT00810043|144569967|SUPERIORITY_OR_OTHER|||||||0.9|||||||t-test, 2 sided|||Anterior VBH gained by postural reduction||||0.900
72520350|NCT00810043|144569967|SUPERIORITY_OR_OTHER|||||||0.62|||||||t-test, 2 sided|||Middle VBH gained by postural reduction||||0.620
72520351|NCT00810043|144569967|SUPERIORITY_OR_OTHER|||||||0.349|||||||t-test, 2 sided|||Posterior VBH gained by postural reduction||||0.349
72520352|NCT00810043|144569968|SUPERIORITY_OR_OTHER|||||||0.889|||||||t-test, 2 sided|||||||0.889
72520353|NCT00810043|144569969|SUPERIORITY_OR_OTHER|||||||0.486|||||||t-test, 2 sided|||||||0.486
72520354|NCT00810043|144569970|SUPERIORITY_OR_OTHER|||||||0.144|||||||t-test, 2 sided|||||||0.144
72520355|NCT00810043|144569971|SUPERIORITY_OR_OTHER|||||||0.36|||||||Chi-squared|||||||0.360
72520356|NCT03364491|144569976|SUPERIORITY|Model included treatment and preoperative hemoglobin level \<8 g/dL (yes/no) as covariates. We estimated that a total sample size of 11,000 participants (5,500 per group) would achieve 85% power to detect a 33% lower incidence of the primary outcome (1.67%) in the TXA group, at a type I error rate (two-sided) of 5%.|Risk Ratio (RR)|0.89||||0.19|TWO_SIDED|95.26|0.74|1.07||Following two interim analyses, a two-tailed P value of less than 0.047 was considered to indicate statistical significance.|Other (Log-binomial regression model)|||||1.07|0.74|0.19
72520357|NCT00968708|144570021|NON_INFERIORITY_OR_EQUIVALENCE|If after accrual of 550 participants with MACE events, the upper bound of a 1-sided repeated CI for the hazard ratio (alogliptin to placebo) was \<1.0, superiority of alogliptin to placebo for the primary MACE composite would be concluded. If the upper bound of the 1-sided repeated CI for the hazard ratio of the primary MACE composite was \<1.3 but ≥1.0 then non-inferiority but not superiority of alogliptin to placebo was to be concluded.|Hazard Ratio (HR)|0.962||||0.315|ONE_SIDED|97.5||1.16|||Cox proportional hazards|||Statistical analyses of the primary MACE composite endpoint was based on sequences of 1-sided repeated confidence intervals (CIs) to assess non-inferiority or statistical superiority with respect to the null hypotheses. Each sequence of repeated CIs was constructed using critical values from a 1-sided stopping boundary for a group sequential design (GSD), to preserve an overall false-rejection rate of 2.5%. Each sequence of 1-sided repeated CIs had a simultaneous coverage probability of 97.5%.||1.160||0.315
72520358|NCT00968708|144570021|NON_INFERIORITY_OR_EQUIVALENCE|If after accrual of 550 participants with MACE events, the upper bound of a 1-sided repeated CI for the hazard ratio (alogliptin to placebo) was \<1.0, superiority of alogliptin to placebo for the primary MACE composite would be concluded. If the upper bound of the 1-sided repeated CI for the hazard ratio of the primary MACE composite was \<1.3 but ≥1.0 then non-inferiority but not superiority of alogliptin to placebo was to be concluded.|Hazard Ratio (HR)|0.965||||0.332|ONE_SIDED|97.5||1.169||Stratified by endpoint renal function (defined as the last observed postbaseline renal function (normal renal function/mild renal impairment vs moderate/severe renal impairment including end-stage renal disease)) and geographic region.|Cox proportional hazards|||Stratified by endpoint renal function and geographic region||1.169||0.332
72520359|NCT00968708|144570022|NON_INFERIORITY_OR_EQUIVALENCE|If the upper bound of the confidence interval for the primary MACE composite was \<1.0, then statistical superiority of alogliptin to placebo for the secondary MACE composite would be demonstrated.|Hazard Ratio (HR)|0.952|||||ONE_SIDED|97.5||1.135||||||||1.135||
72520360|NCT01150760|144570042|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.6||||0.0007|||||||Chi-squared|||||||0.0007
72520361|NCT01150760|144570043|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.9|||<|0.0001|||||||Chi-squared|||||||< 0.0001
72520362|NCT01150760|144570044|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.6||||0.0001|||||||Chi-squared|||||||0.0001
72520363|NCT01150760|144570045|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.3||||0.1022|||||||Chi-squared|||||||0.1022
72520364|NCT01150760|144570046|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.2|||<|0.0001|||||||Chi-squared|||||||< 0.0001
72520365|NCT01150760|144570047|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.1|||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||< 0.0001
72520366|NCT01150760|144570048|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.3||||0.0012|||||||Chi-squared|||||||0.0012
72520367|NCT01150760|144570049|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.9||||0.003|||||||Chi-squared|||||||0.0030
72520368|NCT01150760|144570050|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1||||0.7637|||||||Chi-squared|||||||0.7637
72520369|NCT01150760|144570051|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.3||||0.0402|||||||Chi-squared|||||||0.0402
72520370|NCT01150760|144570052|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.6||||0.0755|||||||Chi-squared|||||||0.0755
72520371|NCT01150760|144570053|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.9||||0.0532|||||||Chi-squared|||||||0.0532
72520372|NCT01150760|144570054|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Chi-squared|||||||< 0.0001
72520373|NCT01150760|144570055|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.3|||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||< 0.0001
72405809|NCT02659020|144320138|SUPERIORITY||Hazard Ratio (HR)|0.947||||0.821|TWO_SIDED|95.0|0.622|1.442||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|Log Rank||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|Dyspnoea||1.442|0.622|0.821
72405810|NCT02659020|144320138|SUPERIORITY||Hazard Ratio (HR)|0.931||||0.812|TWO_SIDED|95.0|0.574|1.509||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|Log Rank||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|Insomnia||1.509|0.574|0.812
72405811|NCT02659020|144320138|SUPERIORITY||Hazard Ratio (HR)|1.355||||0.162|TWO_SIDED|95.0|0.893|2.055||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|Log Rank||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|Appetite loss||2.055|0.893|0.162
72405812|NCT02659020|144320138|SUPERIORITY||Hazard Ratio (HR)|0.881||||0.619|TWO_SIDED|95.0|0.55|1.413||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|Log Rank||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|Constipation||1.413|0.550|0.619
72520374|NCT01975675|144570062|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Treatment-naive noncirrhotic participants in the LDV/SOF (treatment naive) group were compared to the adjusted historical SVR null rate of 63% using a two-sided exact one-sample binomial test.|Binomial test|||||||< 0.001
72520375|NCT01975675|144570062|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Treatment-naive noncirrhotic participants in the LDV/SOF+RBV (treatment naive) group were compared to the adjusted historical SVR null rate of 63% using a two-sided exact one-sample binomial test.|Binomial test|||||||< 0.001
72520376|NCT01975675|144570063|SUPERIORITY_OR_OTHER||Difference in proportions|-3.6|||||TWO_SIDED|95.0|-10.2|1.0|||||The 95% confidence interval (CI) on the difference in proportions is based on the exact method (standardized statistic and inverting two 1-sided tests).|||1.0|-10.2|
72520377|NCT01975675|144570063|SUPERIORITY_OR_OTHER||Difference in proportions|0.0|||||TWO_SIDED|95.0|-4.2|4.2|||||The 95% CI on the difference in proportions is based on the exact method (standardized statistic and inverting two 1-sided tests).|||4.2|-4.2|
72520378|NCT00871572|144570090|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.94||||0.0296|TWO_SIDED|90.0|-1.64|-0.23|||Mixed Models Analysis|||||-0.23|-1.64|0.0296
72405813|NCT02659020|144320138|SUPERIORITY||Hazard Ratio (HR)|1.134||||0.597|TWO_SIDED|95.0|0.746|1.724||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|Log Rank||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|Diarrhoea||1.724|0.746|0.597
72405814|NCT02659020|144320138|SUPERIORITY||Hazard Ratio (HR)|0.766||||0.38|TWO_SIDED|95.0|0.425|1.381||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|Log Rank||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|Financial difficulties||1.381|0.425|0.380
72405815|NCT02659020|144320138|SUPERIORITY||Hazard Ratio (HR)|1.046||||0.877|TWO_SIDED|95.0|0.635|1.723||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|Log Rank||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|Fatigue||1.723|0.635|0.877
72520379|NCT00871572|144570090|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.76||||0.0418|TWO_SIDED|90.0|-1.37|-0.15|||Mixed Models Analysis|||||-0.15|-1.37|0.0418
72520380|NCT00871572|144570090|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.76||||0.0514|TWO_SIDED|90.0|-1.41|-0.12|||Mixed Models Analysis|||||-0.12|-1.41|0.0514
72520381|NCT00871572|144570091|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.62||||0.2565|TWO_SIDED|95.0|-4.46|1.21|||Mixed Models Analysis|||||1.21|-4.46|0.2565
72520382|NCT00871572|144570091|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.86||||0.1245|TWO_SIDED|95.0|-4.25|0.53|||Mixed Models Analysis|||||0.53|-4.25|0.1245
72520383|NCT00871572|144570091|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.41||||0.0594|TWO_SIDED|95.0|-4.92|0.1|||Mixed Models Analysis|||||0.10|-4.92|0.0594
72520384|NCT00871572|144570092|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-124.56||||0.4978|TWO_SIDED|95.0|-490.02|240.9|||ANCOVA|||||240.90|-490.02|0.4978
72520385|NCT00871572|144570092|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-338.64||||0.0372|TWO_SIDED|95.0|-656.55|-20.72|||ANCOVA|||||-20.72|-656.55|0.0372
72520386|NCT00871572|144570092|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-466.83||||0.0068|TWO_SIDED|95.0|-799.48|-134.18|||ANCOVA|||||-134.18|-799.48|0.0068
72520387|NCT00871572|144570093|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||0.814|TWO_SIDED|95.0|-0.5|0.7|||ANCOVA|||||0.7|-0.5|0.814
72520388|NCT00871572|144570093|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||0.681|TWO_SIDED|95.0|-0.4|0.7|||ANCOVA|||||0.7|-0.4|0.681
72520389|NCT00871572|144570093|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.715|TWO_SIDED|95.0|-0.7|0.5|||ANCOVA|||||0.5|-0.7|0.715
72520390|NCT00871572|144570096|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-23.56||||0.0248|TWO_SIDED|95.0|-44.03|-3.09||P-value is for Pre-Morning Meal (fasting).|Mixed Models Analysis|||||-3.09|-44.03|0.0248
72569806|NCT02944383|144670008|SUPERIORITY|||||||0.6604||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.6604
72520391|NCT00871572|144570096|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-35.28||||0.0002|TWO_SIDED|95.0|-53.08|-17.48||P-value is for Pre-Morning Meal (fasting).|Mixed Models Analysis|||||-17.48|-53.08|0.0002
72520392|NCT00871572|144570096|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-39.32|||<|0.0001|TWO_SIDED|95.0|-58.12|-20.53||P-value is for Pre-Morning Meal (fasting).|Mixed Models Analysis|||||-20.53|-58.12|<0.0001
72520393|NCT00871572|144570096|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.42||||0.6513|TWO_SIDED|95.0|-34.66|21.82||P-value is for 2 Hours After Morning Meal.|Mixed Models Analysis|||||21.82|-34.66|0.6513
72520394|NCT00871572|144570096|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.2||||0.5045|TWO_SIDED|95.0|-32.61|16.21||P-value is for 2 Hours After Morning Meal.|Mixed Models Analysis|||||16.21|-32.61|0.5045
72520395|NCT00871572|144570096|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.2||||0.5774|TWO_SIDED|95.0|-32.9|18.49||P-value is for 2 Hours After Morning Meal.|Mixed Models Analysis|||||18.49|-32.90|0.5774
72520396|NCT00871572|144570096|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-35.81||||0.0045|TWO_SIDED|95.0|-60.1|-11.53||P-value is for Pre-Mid-Day Meal.|Mixed Models Analysis|||||-11.53|-60.10|0.0045
72520397|NCT00871572|144570096|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-33.15||||0.0024|TWO_SIDED|95.0|-54.1|-12.21||P-value is for Pre-Mid-Day Meal.|Mixed Models Analysis|||||-12.21|-54.10|0.0024
72520398|NCT00871572|144570096|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-37.87||||0.0011|TWO_SIDED|95.0|-59.98|-15.75||P-value is for Pre-Mid-Day Meal.|Mixed Models Analysis|||||-15.75|-59.98|0.0011
72520399|NCT00871572|144570096|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-28.48||||0.0389|TWO_SIDED|95.0|-55.47|-1.49||P-value is for 2 Hours After Mid-Day Meal.|Mixed Models Analysis|||||-1.49|-55.47|0.0389
72520400|NCT00871572|144570096|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.65||||0.1896|TWO_SIDED|95.0|-39.24|7.94||P-value is for 2 Hours After Mid-Day Meal.|Mixed Models Analysis|||||7.94|-39.24|0.1896
72520401|NCT00871572|144570096|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-22.56||||0.0729|TWO_SIDED|95.0|-47.28|2.16||P-value is for 2 Hours After Mid-Day Meal.|Mixed Models Analysis|||||2.16|-47.28|0.0729
72520402|NCT00871572|144570096|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-44.78||||0.0041|TWO_SIDED|95.0|-74.79|-14.77||P-value is for Pre Evening Meal.|Mixed Models Analysis|||||-14.77|-74.79|0.0041
72520403|NCT00871572|144570096|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-54.45|||<|0.0001|TWO_SIDED|95.0|-80.42|-28.48||P-value is for Pre Evening Meal.|Mixed Models Analysis|||||-28.48|-80.42|<0.0001
72520404|NCT00871572|144570096|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-46.19||||0.0013|TWO_SIDED|95.0|-73.57|-18.81||P-value is for Pre Evening Meal.|Mixed Models Analysis|||||-18.81|-73.57|0.0013
72520405|NCT00871572|144570096|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-39.82||||0.0118|TWO_SIDED|95.0|-70.51|-9.13||P-value is for 2 Hours After Evening Meal.|Mixed Models Analysis|||||-9.13|-70.51|0.0118
72520406|NCT00871572|144570096|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-43.8||||0.0016|TWO_SIDED|95.0|-70.42|-17.18||P-value is for 2 Hours After Evening Meal.|Mixed Models Analysis|||||-17.18|-70.42|0.0016
72520407|NCT00871572|144570096|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-39.56||||0.0065|TWO_SIDED|95.0|-67.63|-11.48||P-value is for 2 Hours After Evening Meal.|Mixed Models Analysis|||||-11.48|-67.63|0.0065
72520408|NCT00871572|144570096|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-36.88||||0.0154|TWO_SIDED|95.0|-66.43|-7.33||P-value is for Bedtime.|Mixed Models Analysis|||||-7.33|-66.43|0.0154
72520409|NCT00871572|144570096|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-46.5||||0.0006|TWO_SIDED|95.0|-71.93|-21.07||P-value is for Bedtime.|Mixed Models Analysis|||||-21.07|-71.93|0.0006
72520410|NCT00871572|144570096|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-42.07||||0.0029|TWO_SIDED|95.0|-69.13|-15.01||P-value is for Bedtime.|Mixed Models Analysis|||||-15.01|-69.13|0.0029
72520411|NCT00871572|144570097|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|25.62||||0.3815|TWO_SIDED|95.0|-32.44|83.68|||Mixed Models Analysis|||||83.68|-32.44|0.3815
72520412|NCT00871572|144570097|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.4||||0.8315|TWO_SIDED|95.0|-45.12|55.93|||Mixed Models Analysis|||||55.93|-45.12|0.8315
72520413|NCT00871572|144570097|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|24.25||||0.3658|TWO_SIDED|95.0|-28.93|77.44|||Mixed Models Analysis|||||77.44|-28.93|0.3658
72520414|NCT00871572|144570098|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|55.06||||0.2131|TWO_SIDED|95.0|-32.24|142.37|||Mixed Models Analysis|||||142.37|-32.24|0.2131
72520415|NCT00871572|144570098|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|89.68||||0.022|TWO_SIDED|95.0|13.27|166.1|||Mixed Models Analysis|||||166.10|13.27|0.0220
72520416|NCT00871572|144570098|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|107.26||||0.0101|TWO_SIDED|95.0|26.29|188.22|||Mixed Models Analysis|||||188.22|26.29|0.0101
72520417|NCT00871572|144570099|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.87||||0.1596|TWO_SIDED|95.0|-0.75|4.49|||Mixed Models Analysis|||||4.49|-0.75|0.1596
72520418|NCT00871572|144570099|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.03||||0.0791|TWO_SIDED|95.0|-0.24|4.31|||Mixed Models Analysis|||||4.31|-0.24|0.0791
72520419|NCT00871572|144570099|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.71||||0.1564|TWO_SIDED|95.0|-0.67|4.1|||Mixed Models Analysis|||||4.10|-0.67|0.1564
72520420|NCT00871572|144570100|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8018.51||||0.45|TWO_SIDED|95.0|-13104.14|29141.16|||ANCOVA|||||29141.16|-13104.14|0.4500
72520421|NCT00871572|144570100|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5174.85||||0.5739|TWO_SIDED|95.0|-13158.65|23508.35|||ANCOVA|||||23508.35|-13158.65|0.5739
72520422|NCT00871572|144570100|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|18153.92||||0.0653|TWO_SIDED|95.0|-1188.23|37496.06|||ANCOVA|||||37496.06|-1188.23|0.0653
72520423|NCT00871572|144570101|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|18094.32||||0.6209|TWO_SIDED|95.0|-54734.08|90922.71|||ANCOVA|||||90922.71|-54734.08|0.6209
72520424|NCT00871572|144570101|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5783.59||||0.8581|TWO_SIDED|95.0|-58650.71|70217.89|||ANCOVA|||||70217.89|-58650.71|0.8581
72520425|NCT00871572|144570101|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|36218.98||||0.285|TWO_SIDED|95.0|-30955.5|103393.46|||ANCOVA|||||103393.46|-30955.50|0.2850
72405816|NCT02659020|144320138|SUPERIORITY||Hazard Ratio (HR)|1.102||||0.791|TWO_SIDED|95.0|0.568|2.139||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|Log Rank||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|Nausea and vomiting||2.139|0.568|0.791
72520426|NCT00871572|144570102|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.584|TWO_SIDED|95.0|-0.7|0.4|||ANCOVA|||||0.4|-0.7|0.584
72520427|NCT00871572|144570102|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2||||0.426|TWO_SIDED|95.0|-0.7|0.3|||ANCOVA|||||0.3|-0.7|0.426
72520428|NCT00871572|144570102|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.657|TWO_SIDED|95.0|-0.6|0.4|||ANCOVA|||||0.4|-0.6|0.657
72520429|NCT00871572|144570103|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||0.365|TWO_SIDED|95.0|-0.1|0.4|||ANCOVA|||||0.4|-0.1|0.365
72520430|NCT00871572|144570103|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2||||0.191|TWO_SIDED|95.0|-0.1|0.4|||ANCOVA|||||0.4|-0.1|0.191
72569807|NCT02944383|144670008|SUPERIORITY|||||||0.0952||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.0952
72569808|NCT02944383|144670008|SUPERIORITY|||||||0.3006||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.3006
72569809|NCT02944383|144670008|SUPERIORITY|||||||0.0642||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||EOS (average of week 10 and 12)||||0.0642
72569810|NCT02944383|144670008|SUPERIORITY|||||||0.3185||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||EOS (average of week 10 and 12)||||0.3185
72624972|NCT02757768|144779456|SUPERIORITY||LS Mean of Difference|-1.1|STANDARD_ERROR_OF_MEAN|1.05||0.293|TWO_SIDED|95.0|-3.16|0.95|||ANCOVA|||Week 4 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||0.95|-3.16|0.293
72520431|NCT00871572|144570103|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||0.297|TWO_SIDED|95.0|-0.1|0.4|||ANCOVA|||||0.4|-0.1|0.297
72520432|NCT00871572|144570104|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2||||0.523|TWO_SIDED|95.0|-0.8|0.4|||ANCOVA|||||0.4|-0.8|0.523
72520433|NCT00871572|144570104|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2||||0.476|TWO_SIDED|95.0|-0.7|0.3|||ANCOVA|||||0.3|-0.7|0.476
72520434|NCT00871572|144570104|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.634|TWO_SIDED|95.0|-0.7|0.4|||ANCOVA|||||0.4|-0.7|0.634
72569811|NCT02944383|144670009|SUPERIORITY|||||||0.0679||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.0679
72569812|NCT02944383|144670009|SUPERIORITY|||||||0.4126||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.4126
72520435|NCT00871572|144570105|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.919|TWO_SIDED|95.0|-0.6|0.6|||ANCOVA|||||0.6|-0.6|0.919
72520436|NCT00871572|144570105|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.864|TWO_SIDED|95.0|-0.5|0.6|||ANCOVA|||||0.6|-0.5|0.864
72520437|NCT00871572|144570105|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||0.726|TWO_SIDED|95.0|-0.5|0.7|||ANCOVA|||||0.7|-0.5|0.726
72520438|NCT00735670|144570106|SUPERIORITY_OR_OTHER|||||||0.445|||||||Fisher Exact|||||||0.445
72520439|NCT00735670|144570107|SUPERIORITY_OR_OTHER||REML|-0.31||||0.725|TWO_SIDED|95.0|-0.48|-0.15||Comparison of venlafaxine vs. placebo on change of PHQ-9 over time controlling for baseline PHQ-9 score.|Mixed Models Analysis|||A linear mixed model (LMM) analysis was used and included a random intercept effect based on lowest Akaike's Information Criterion values when we compared three random coefficient models (intercept, slope and intercept and slope). To examine whether allocation group influenced the effect of time and baseline PHQ-9 sore on the trajectory of PHQ-9 scores, we included two interaction terms (time by allocation group and baseline PHQ-9 score by allocation group).||-0.15|-0.48|0.725
72520440|NCT00187889|144570112|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-9.6|STANDARD_ERROR_OF_MEAN|6.7||0.15|TWO_SIDED|95.0|-22.8|3.6||The P-value applies to this comparison, without adjustment, to the completers of the trial.|Satterthwaite corrected t-test||An expanded definition of the outcome measure is the difference between the percentage change (week 16) and the percentage change week 0). This is a calculation based on 4 measurements.|The null hypothesis is that the treatments are equivalent with respect to the primary outcome. The Satterthwaite corrected t-tests adjusts for potentially unequal variance in the groups.||3.6|-22.8|0.15
72520441|NCT00187889|144570112|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.04|STANDARD_ERROR_OF_MEAN|0.39||0.92|TWO_SIDED|95.0|-0.79|0.72|||Satterthwaite corrected t-test||The Satterthwaite corrected t-tests adjusts for potentially unequal variance in the groups. This is a different outcome variable than the primary.|The null hypothesis is that treatments are equivalent on this outcome. The study was powered around the primary outcome. No adjustment for multiple comparisons was planned.||0.72|-0.79|0.92
72569813|NCT02944383|144670009|SUPERIORITY|||||||0.0095||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.0095
72405817|NCT02659020|144320138|SUPERIORITY||Hazard Ratio (HR)|0.81||||0.487|TWO_SIDED|95.0|0.454|1.443||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|Log Rank||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|Pain||1.443|0.454|0.487
72405818|NCT02659020|144320138|SUPERIORITY||Hazard Ratio (HR)|1.014||||0.976|TWO_SIDED|95.0|0.556|1.85||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|Log Rank||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|Dyspnoea||1.850|0.556|0.976
72405819|NCT02659020|144320138|SUPERIORITY||Hazard Ratio (HR)|1.694||||0.111|TWO_SIDED|95.0|0.882|3.25||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|Log Rank||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|Insomnia||3.250|0.882|0.111
72405820|NCT02659020|144320138|SUPERIORITY||Hazard Ratio (HR)|1.108||||0.76|TWO_SIDED|95.0|0.62|1.979||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|Log Rank||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|Appetite loss||1.979|0.620|0.760
72405821|NCT02659020|144320138|SUPERIORITY||Hazard Ratio (HR)|1.119||||0.747|TWO_SIDED|95.0|0.586|2.135||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|Log Rank||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|Constipation||2.135|0.586|0.747
72520442|NCT00108953|144570155|SUPERIORITY_OR_OTHER||Hazard Ratio, log|0.6||||0.016||95.0|0.33|0.95|||Log Rank||Hazard ratio: nexavar+doxorubicin over placebo+doxorubicin|The comparison between the 2 groups is done using the log rank test stratified by tumor burden. The null hypothesis is: TTP is the same in both treatment groups.||0.95|0.33|0.016
72520443|NCT00108953|144570156|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.52||||0.007||95.0|0.37|0.74|||Log Rank||Hazard ratio: nexavar+doxorubicin over placebo+doxorubicin|The comparison between the 2 groups is done using the log rank test stratified by tumor burden. The null hypothesis is: TTP is the same in both treatment groups||0.74|0.37|0.007
72520444|NCT00108953|144570157|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.61||||0.018||95.0|0.45|0.83|||Log Rank||Hazard ratio: nexavar+doxorubicin over placebo+doxorubicin|The comparison between the 2 groups is done using the log rank test stratified by tumor burden. The null hypothesis is: TTP is the same in both treatment groups||0.83|0.45|0.018
72405822|NCT02659020|144320138|SUPERIORITY||Hazard Ratio (HR)|1.367||||0.33|TWO_SIDED|95.0|0.726|2.576||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|Log Rank||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|Diarrhoea||2.576|0.726|0.330
72405823|NCT02659020|144320138|SUPERIORITY||Hazard Ratio (HR)|1.373||||0.411|TWO_SIDED|95.0|0.636|2.965||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|Log Rank||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|Financial difficulties||2.965|0.636|0.411
72405824|NCT04382911|144320141|EQUIVALENCE|A 2x2 table was constructed among all patients with histopathologically identified endometriosis (true positive) to compare sensitivity for FES PET/MRI versus sensitivity of conventional MRI.||||||0.317|||||||McNemar|||||||0.317
72405825|NCT04382911|144320144|OTHER|A random effects linear regression model, modeling SUV-max as a function of the pain rating, while controlling for patient-level covariates (BMI, race, age) was performed. The investigators included physician as a random effect to account for physician-level correlation.|Slope|0.748||||0.24|TWO_SIDED||||||Pearson's Correlation Coefficient|||||||0.24
72405826|NCT04382911|144320144|OTHER|The investigators will implement a random effects linear regression model, modeling SUV-max as a function of EHP-30, while controlling for patient-level covariates (BMI, race, age). The investigators will include physician as a random effect to account for physician-level correlation.|Slope|0.406||||0.13|TWO_SIDED||||||Mixed Models Analysis|||||||0.13
72405827|NCT01120210|144320145|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.27||||0.0595|TWO_SIDED|90.0|-0.016|0.564|||ANCOVA|one-sided p-value and one-sided alpha=0.05||90% confidence intervals and p values represent the placebo-subtracted LS mean change from baseline in cardiac index (CI) at the end of the 5 ng/kg/min dose.||0.564|-0.016|0.0595
72520445|NCT00108953|144570159|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.65||||0.038||95.0|0.4|1.05|||Log Rank||Hazard ratio: nexavar+doxorubicin over placebo+doxorubicin|The comparison between the 2 groups is done using the log rank test stratified by tumor burden. The null hypothesis is: TTP is the same in both treatment groups||1.05|0.40|0.038
72520446|NCT01854593|144570165|SUPERIORITY_OR_OTHER|||||||0.025|||||||Wilcoxon (Mann-Whitney)|||||||0.025
72520447|NCT01854593|144570166|SUPERIORITY_OR_OTHER|||||||0.006|||||||Chi-squared|||||||0.006
72520448|NCT01854593|144570167|SUPERIORITY_OR_OTHER|||||||0.033|||||||Fisher Exact|||||||0.033
72520449|NCT01854593|144570168|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
72520450|NCT01854593|144570169|SUPERIORITY_OR_OTHER|||||||0.667|||||||Wilcoxon (Mann-Whitney)|||||||0.667
72520451|NCT01854593|144570170|SUPERIORITY_OR_OTHER|||||||0.593|||||||Fisher Exact|||||||0.593
72520452|NCT01854593|144570171|SUPERIORITY_OR_OTHER|||||||0.298|||||||Wilcoxon (Mann-Whitney)|||||||0.298
72520453|NCT01854593|144570172|SUPERIORITY_OR_OTHER|||||||0.929|||||||Wilcoxon (Mann-Whitney)|||||||0.929
72520454|NCT01854593|144570173|SUPERIORITY_OR_OTHER|||||||0.445|||||||Wilcoxon (Mann-Whitney)|||||||0.445
72520455|NCT01854593|144570174|SUPERIORITY_OR_OTHER|||||||0.131|||||||Chi-squared|||||||0.131
72520456|NCT01854593|144570175|SUPERIORITY_OR_OTHER|||||||0.149|||||||Fisher Exact|||||||0.149
72520457|NCT01854593|144570176|SUPERIORITY_OR_OTHER|||||||0.67|||||||Fisher Exact|||||||0.670
72520458|NCT01854593|144570177|SUPERIORITY_OR_OTHER|||||||0.378|||||||Chi-squared|||||||0.378
72520459|NCT01125293|144570241|OTHER|||||||0.69|||||||Two stage design, exact method|||In a two-stage Simon design, a VGPR or better rate of at least 18% is considered promising versus a 5% or less rate. In stage 1, if 1 or fewer of 23 evaluable participants achieve VGPR, the regimen is considered non-promising else continue with 24 more patients enrolled. If \</=4 of 47 evaluable patients have VGPR or better, the regimen is considered non-promising. If \>/=5, then the regimen is considered promising for further study. With this design, there is 90% power and 1-sided 10% alpha.|The study did not continue to stage 2 given 1 VGPR or better response was observed in 23 evaluable participants in stage 1.|||0.69
72520460|NCT01367860|144570250|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.89|STANDARD_ERROR_OF_MEAN|1.06||0.05|TWO_SIDED|95.0|-4.05|0.26|||t-test, 2 sided|||||0.26|-4.05|0.05
72520461|NCT01367860|144570251|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Fisher Exact|||||||<0.05
72520462|NCT01367860|144570252|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.39|STANDARD_ERROR_OF_MEAN|0.9|<|0.05|TWO_SIDED|95.0|-2.21|1.43|||t-test, 2 sided|||||1.43|-2.21|<0.05
72520463|NCT01367860|144570253|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.71|STANDARD_ERROR_OF_MEAN|1.01|<|0.05|TWO_SIDED|95.0|-2.76|1.33|||t-test, 2 sided|||||1.33|-2.76|<0.05
72520464|NCT01367860|144570255|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.28|STANDARD_ERROR_OF_MEAN|1.13|<|0.05|TWO_SIDED|95.0|-2.58|2.01|||t-test, 2 sided|||||2.01|-2.58|<0.05
72520465|NCT01367860|144570256|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.02|STANDARD_ERROR_OF_MEAN|1.14|<|0.05|TWO_SIDED|95.0|-1.3|3.3|||t-test, 2 sided|||||3.3|-1.3|<0.05
72405828|NCT01120210|144320145|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.33||||0.0215|TWO_SIDED|90.0|0.064|0.595||one-sided p-value and one-sided alpha=0.05|ANCOVA|||90% confidence intervals and p values represent the placebo-subtracted LS mean change from baseline in cardiac index (CI) at the end of the 15 ng/kg/min dose.||0.595|0.064|0.0215
72520466|NCT01367860|144570257|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|3.2|STANDARD_ERROR_OF_MEAN|2.77|<|0.05|TWO_SIDED|95.0|-2.36|8.8|||t-test, 2 sided|||||8.8|-2.36|<0.05
72520467|NCT01367860|144570258|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|2.2|STANDARD_ERROR_OF_MEAN|3.3|<|0.05|TWO_SIDED|95.0|-4.4|8.9|||t-test, 2 sided|||||8.9|-4.4|<0.05
72520468|NCT01367860|144570259|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|3.6|<|0.05|TWO_SIDED|95.0|-7.15|7.55|||t-test, 2 sided|||||7.55|-7.15|<0.05
72520469|NCT01367860|144570260|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.26|STANDARD_ERROR_OF_MEAN|3.65|<|0.05|TWO_SIDED|95.0|-7.14|7.67|||t-test, 2 sided|||||7.67|-7.14|<0.05
72520470|NCT01367860|144570261|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.7|STANDARD_ERROR_OF_MEAN|3.18|<|0.05|TWO_SIDED|95.0|-8.16|4.76|||t-test, 2 sided|||||4.76|-8.16|<0.05
72520471|NCT01367860|144570262|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.67|STANDARD_ERROR_OF_MEAN|0.88|<|0.05|TWO_SIDED|95.0|-0.12|3.46|||t-test, 2 sided|||||3.46|-0.12|<0.05
72520472|NCT01367860|144570263|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.19|STANDARD_ERROR_OF_MEAN|1.09|<|0.05|TWO_SIDED|95.0|-2.0|2.4|||t-test, 2 sided|||||2.4|-2|<0.05
72520473|NCT01367860|144570264|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.34|STANDARD_ERROR_OF_MEAN|1.08|<|0.05|TWO_SIDED|95.0|-2.55|1.85|||t-test, 2 sided|||||1.85|-2.55|<0.05
72520474|NCT01367860|144570265|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.33|STANDARD_ERROR_OF_MEAN|1.11|<|0.05|TWO_SIDED|95.0|-2.29|2.23|||t-test, 2 sided|||||2.23|-2.29|<0.05
72520475|NCT01367860|144570266|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.7|STANDARD_ERROR_OF_MEAN|1.17|<|0.05|TWO_SIDED|95.0|-1.67|3.08|||t-test, 2 sided|||||3.08|-1.67|<0.05
72520476|NCT01270958|144570271|SUPERIORITY_OR_OTHER||||||>|0.05||95.0||||Comparison between Screening value and Visit 3 value|t-test, 2 sided|||||||>0.05
72520477|NCT01270958|144570272|SUPERIORITY_OR_OTHER||||||>|0.05||95.0||||Comparison between Screening value and Visit 3 value|t-test, 2 sided|||||||>0.05
72520478|NCT01270958|144570273|SUPERIORITY_OR_OTHER||||||>|0.05||95.0||||Comparison between Screening value and Visit 3 value|t-test, 2 sided|||||||>0.05
72520479|NCT01270958|144570274|SUPERIORITY_OR_OTHER||||||>|0.05||95.0||||Comparison between Screening value and Visit 3 value|t-test, 2 sided|||||||>0.05
72520480|NCT01270958|144570275|SUPERIORITY_OR_OTHER||||||>|0.05||95.0||||Comparison between Screening value and Visit 3 value|t-test, 2 sided|||||||>0.05
72520481|NCT01270958|144570276|SUPERIORITY_OR_OTHER||||||>|0.05||95.0||||Comparison between Screening value and Visit 3 value|t-test, 2 sided|||||||>0.05
72520482|NCT01270958|144570277|SUPERIORITY_OR_OTHER||||||>|0.05||95.0||||Comparison between Screening value and Visit 3 value|t-test, 2 sided|||||||>0.05
72520483|NCT01270958|144570278|SUPERIORITY_OR_OTHER||||||>|0.05||95.0||||Comparison between Screening value and Visit 3 value|t-test, 2 sided|||||||>0.05
72520484|NCT01270958|144570279|SUPERIORITY_OR_OTHER||||||<|0.01||95.0||||Comparison between Screening value and Visit 3 value|t-test, 2 sided|||||||<0.01
72520485|NCT01270958|144570280|SUPERIORITY_OR_OTHER||||||>|0.05||95.0||||Comparison between Screening value and Visit 3 value|t-test, 2 sided|||||||>0.05
72520486|NCT01270958|144570281|SUPERIORITY_OR_OTHER||||||>|0.05||95.0||||Comparison between Screening value and Visit 3 value|t-test, 2 sided|||||||>0.05
72520487|NCT01270958|144570282|SUPERIORITY_OR_OTHER||||||>|0.05||95.0||||Comparison between Screening value and Visit 3 value|t-test, 2 sided|||||||>0.05
72520488|NCT01270958|144570283|SUPERIORITY_OR_OTHER||||||>|0.05||95.0||||Comparison between Screening value and Visit 3 value|t-test, 2 sided|||||||>0.05
72520489|NCT01270958|144570284|SUPERIORITY_OR_OTHER||||||>|0.05||95.0||||Comparison between Screening value and Visit 3 value|t-test, 2 sided|||||||>0.05
72520490|NCT01270958|144570285|SUPERIORITY_OR_OTHER||||||>|0.05||95.0||||Comparison between Screening value and Visit 3 value|t-test, 2 sided|||||||>0.05
72520491|NCT01270958|144570286|SUPERIORITY_OR_OTHER||||||>|0.05||95.0||||Comparison between Screening value and Visit 3 value|t-test, 2 sided|||||||>0.05
72520492|NCT01270958|144570287|SUPERIORITY_OR_OTHER||||||>|0.05||95.0||||Comparison between Screening value and Visit 3 value|t-test, 2 sided|||||||>0.05
72520493|NCT01270958|144570288|SUPERIORITY_OR_OTHER||||||>|0.05||95.0||||Comparison between Screening value and Visit 3 value|t-test, 2 sided|||||||>0.05
72520494|NCT01270958|144570289|SUPERIORITY_OR_OTHER||||||>|0.05||95.0||||Comparison between Screening value and Visit 3 value|t-test, 2 sided|||||||>0.05
72520495|NCT03136367|144570349|SUPERIORITY|||||||0.045||||||Adjusted for repeated within-patient measurements.|Mixed Models Analysis|Mixed effects linear regression that accounted for clinician and site clustering and was adjusted for surgeon and patient characteristics.||||||0.045
72520496|NCT03136367|144570349|SUPERIORITY|||||||0.2||||||Adjusted for repeated within-patient measurements.|Mixed Models Analysis|Mixed effects linear regression that accounted for clinician and site clustering and was adjusted for surgeon and patient characteristics.||||||0.20
72520497|NCT03136367|144570349|SUPERIORITY|||||||0.82||||||Adjusted for repeated within-patient measurements.|Mixed Models Analysis|Mixed effects linear regression that accounted for clinician and site clustering and was adjusted for surgeon and patient characteristics.||||||0.82
72520498|NCT03136367|144570350|SUPERIORITY|||||||0.048||||||Adjusted for repeated within-patient measurements|Mixed Models Analysis|Mixed effects linear regression that accounted for clinician and site clustering and was adjusted for surgeon and patient characteristics.||||||0.048
72520499|NCT03136367|144570350|SUPERIORITY|||||||0.015||||||Adjusted for repeated within-patient measurements|Mixed Models Analysis|Mixed effects linear regression that accounted for clinician and site clustering and was adjusted for surgeon and patient characteristics.||||||0.015
72520500|NCT03136367|144570350|SUPERIORITY|||||||0.43||||||Adjusted for repeated within-patient measurements.|Mixed Models Analysis|Mixed effects linear regression that accounted for clinician and site clustering and was adjusted for surgeon and patient characteristics.||||||0.43
72520501|NCT03136367|144570351|SUPERIORITY|||||||0.46|||||||Mixed Models Analysis|Mixed effects linear regression that accounted clustering and was adjusted for surgeon and patient characteristics.||||||0.46
72624973|NCT02757768|144779456|SUPERIORITY||LS Mean of Difference|-0.32|STANDARD_ERROR_OF_MEAN|1.12||0.773|TWO_SIDED|95.0|-2.52|1.87|||ANCOVA|||Week 8 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||1.87|-2.52|0.773
72624974|NCT02757768|144779456|SUPERIORITY||LS Mean of Difference|-0.08|STANDARD_ERROR_OF_MEAN|1.12||0.94|TWO_SIDED|95.0|-2.28|2.11|||ANCOVA|||Week 12 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||2.11|-2.28|0.940
72624975|NCT02757768|144779456|SUPERIORITY||LS Mean of Difference|-0.71|STANDARD_ERROR_OF_MEAN|1.1||0.516|TWO_SIDED|95.0|-2.86|1.44|||ANCOVA|||EoT Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||1.44|-2.86|0.516
72520502|NCT03136367|144570351|SUPERIORITY|||||||0.34|||||||Mixed Models Analysis|Mixed effects linear regression that accounted clustering and was adjusted for surgeon and patient characteristics.||||||0.34
72520503|NCT03136367|144570351|SUPERIORITY|||||||0.165|||||||Mixed Models Analysis|Mixed effects linear regression that accounted clustering and was adjusted for surgeon and patient characteristics.||||||0.165
72520504|NCT03136367|144570353|SUPERIORITY|||||||0.25||||||Adjusted for repeated within-patient measurements|Mixed Models Analysis|Mixed effects linear regression that accounted for clinician and site clustering and was adjusted for surgeon and patient characteristics.||||||0.25
72520505|NCT03136367|144570353|SUPERIORITY|||||||0.89||||||Adjusted for repeated within-patient measurements.|Mixed Models Analysis|Mixed effects linear regression that accounted for clinician and site clustering and was adjusted for surgeon and patient characteristics.||||||0.89
72520506|NCT03136367|144570353|SUPERIORITY|||||||0.54||||||Adjusted for repeated within-patient measurements.|Mixed Models Analysis|Mixed effects linear regression that accounted for clinician and site clustering and was adjusted for surgeon and patient characteristics.||||||0.54
72520507|NCT03136367|144570354|SUPERIORITY|||||||0.72||||||Adjusted for repeated within-patient measurements.|Mixed Models Analysis|Mixed effects linear regression that accounted for clinician and site clustering and was adjusted for surgeon and patient characteristics.||||||0.72
72520508|NCT03136367|144570354|SUPERIORITY|||||||0.41||||||Adjusted for repeated within-patient measurements.|McNemar|Mixed effects linear regression that accounted for clinician and site clustering and was adjusted for surgeon and patient characteristics.||||||0.41
72520509|NCT03136367|144570354|SUPERIORITY|||||||0.28||||||Adjusted for repeated within-patient measurements.|Mixed Models Analysis|Mixed effects linear regression that accounted for clinician and site clustering and was adjusted for surgeon and patient characteristics.||||||0.28
72520510|NCT03136367|144570355|SUPERIORITY|||||||0.01|||||||Mixed Models Analysis|Mixed effects linear regression that accounted for clinician and site clustering and was adjusted for surgeon and patient characteristics.||||||0.01
72624976|NCT02757768|144779457|SUPERIORITY|||||||0.4591|||||||t-test, 2 sided|Statistical comparisons were be made using 2-sided tests at α = 0.05 significance level.||Week 4 Placebo vs. Mirabegron.||||0.4591
72624977|NCT02757768|144779457|SUPERIORITY|||||||0.4073|||||||t-test, 2 sided|Statistical comparisons were be made using 2-sided tests at α = 0.05 significance level.||Week 8 Placebo vs. Mirabegron.||||0.4073
72520511|NCT03136367|144570355|SUPERIORITY|||||||0.12|||||||Mixed Models Analysis|Mixed effects linear regression that accounted for clinician and site clustering and was adjusted for surgeon and patient characteristics.||||||0.12
72520512|NCT03136367|144570355|SUPERIORITY|||||||0.78|||||||Mixed Models Analysis|Mixed effects linear regression that accounted for clinician and site clustering and was adjusted for surgeon and patient characteristics.||||||0.78
72520513|NCT03136367|144570356|SUPERIORITY||||||<|0.01|||||||Mixed Models Analysis|Mixed effects linear regression that accounted for clinician and site clustering and was adjusted for surgeon and patient characteristics.||||||<0.01
72520514|NCT03136367|144570356|SUPERIORITY||||||<|0.01|||||||Mixed Models Analysis|Mixed effects linear regression that accounted for clinician and site clustering and was adjusted for surgeon and patient characteristics.||||||<0.01
72520515|NCT03136367|144570357|SUPERIORITY|||||||0.06||||||Adjusted for repeated within-patient measurements.|Mixed Models Analysis|Mixed effects linear regression that accounted for clinician and site clustering and was adjusted for surgeon and patient characteristics.||||||0.06
72520516|NCT03136367|144570357|SUPERIORITY|||||||0.65||||||Adjusted for repeated within-patient measurements.|Mixed Models Analysis|Mixed effects linear regression that accounted for clinician and site clustering and was adjusted for surgeon and patient characteristics.||||||0.65
72520517|NCT03136367|144570357|SUPERIORITY|||||||0.36||||||Adjusted for repeated within-patient measurements.|Mixed Models Analysis|Mixed effects linear regression that accounted for clinician and site clustering and was adjusted for surgeon and patient characteristics.||||||0.36
72520518|NCT03136367|144570358|SUPERIORITY|||||||0.11||||||Adjusted for repeated within-patient measurements.|Mixed Models Analysis|Mixed effects linear regression that accounted for clinician and site clustering and was adjusted for surgeon and patient characteristics.||||||0.11
72520519|NCT03136367|144570358|SUPERIORITY|||||||0.037||||||Adjusted for repeated within-patient measurements.|Mixed Models Analysis|Mixed effects linear regression that accounted for clinician and site clustering and was adjusted for surgeon and patient characteristics.||||||0.037
72520520|NCT03136367|144570358|SUPERIORITY|||||||0.28||||||Adjusted for repeated within-patient measurements.|Mixed Models Analysis|Mixed effects linear regression that accounted for clinician and site clustering and was adjusted for surgeon and patient characteristics.||||||0.28
72520521|NCT00676208|144570360|SUPERIORITY_OR_OTHER_LEGACY|||||||0.04|TWO_SIDED|95.0|||||t-test, 2 sided|||||||0.04
72520522|NCT00676208|144570361|SUPERIORITY_OR_OTHER_LEGACY|||||||0.04|TWO_SIDED|95.0|||||t-test, 2 sided|||||||0.04
72520523|NCT01375647|144570385|SUPERIORITY||Risk Difference (RD)|-2.9||||0.4|TWO_SIDED|95.0|-9.6|3.9|||Chi-squared|2 sided, not adjusted||||3.9|-9.6|0.4
72520524|NCT01375647|144570386|SUPERIORITY||Risk Difference (RD)|13.4||||4e-05|TWO_SIDED|95.0|7.0|19.8||2-sided, no adjustment|Chi-squared|||||19.8|7.0|0.00004
72405829|NCT01120210|144320145|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.57||||0.0049|TWO_SIDED|90.0|0.214|0.921||one-sided p-value and one-sided alpha=0.05|ANCOVA|||90% confidence intervals and p values represent the placebo-subtracted LS mean change from baseline in cardiac index (CI) at the end of the 30 ng/kg/min dose.||0.921|0.214|0.0049
72405830|NCT01120210|144320146|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.09||||0.4729|TWO_SIDED|90.0|-2.312|2.131||one-sided p-value and one-sided alpha=0.05|ANCOVA|||90% confidence intervals and p values represent the placebo-subtracted LS mean change from baseline in pulmonary capillary wedge pressure (PCWP) at the end of the 5 ng/kg/min dose.||2.131|-2.312|0.4729
72520525|NCT01375647|144570387|SUPERIORITY||Mean Difference (Final Values)|0.6||||0.5|TWO_SIDED||||||t-test, 2 sided|||Sabin type 1 shedding||||0.5
72520526|NCT01375647|144570387|SUPERIORITY||Mean Difference (Final Values)|1.2||||0.2|TWO_SIDED||||||t-test, 2 sided|||Sabin type 2 shedding||||0.2
72520527|NCT01375647|144570387|SUPERIORITY||Mean Difference (Final Values)|-1.3||||0.1|TWO_SIDED||||||t-test, 2 sided|||Sabin type 3 shedding||||0.1
72569814|NCT02944383|144670009|SUPERIORITY|||||||0.0172||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.0172
72569815|NCT02944383|144670009|SUPERIORITY||Median Difference (Net)|-23.23||||0.0359|TWO_SIDED|95.0|-41.54|-3.64||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|EOS (average of week 10 and 12)||-3.64|-41.54|0.0359
72520528|NCT01375647|144570389|SUPERIORITY||Risk Difference (RD)|-1.4|||||TWO_SIDED|95.0|-7.3|4.5||||||Sabin type 1||4.5|-7.3|
72520529|NCT01375647|144570389|SUPERIORITY||Risk Difference (RD)|-3.1|||||TWO_SIDED|95.0|-7.2|0.9||||||Sabin type 2||0.9|-7.2|
72520530|NCT01375647|144570389|SUPERIORITY||Risk Difference (RD)|1.4|||||TWO_SIDED|95.0|-3.2|6.1||||||||6.1|-3.2|
72520531|NCT01375647|144570390|SUPERIORITY||Risk Difference (RD)|-33.7|||||TWO_SIDED|95.0|-40.7|-26.5||||||||-26.5|-40.7|
72520532|NCT01375647|144570390|SUPERIORITY||Risk Difference (RD)|-24.3|||||TWO_SIDED|95.0|-31.1|-17.5||||||||-17.5|-31.1|
72520533|NCT01375647|144570390|SUPERIORITY||Risk Difference (RD)|-45.6|||||TWO_SIDED|95.0|-52.6|-38.0||||||||-38.0|-52.6|
72569816|NCT02944383|144670009|SUPERIORITY||Median Difference (Net)|-16.06||||0.0812|TWO_SIDED|95.0|-38.62|5.61||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|EOS (average of week 10 and 12)||5.61|-38.62|0.0812
72624978|NCT02757768|144779457|SUPERIORITY|||||||0.774|||||||t-test, 2 sided|Statistical comparisons were be made using 2-sided tests at α = 0.05 significance level.||Week 12 Placebo vs. Mirabegron.||||0.7740
72520534|NCT01375647|144570391|SUPERIORITY|||||||0.981|||||||Wilcoxon (Mann-Whitney)|||||||0.981
72520535|NCT01375647|144570392|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
72520536|NCT03366844|144570393|OTHER||Proportion|0.6|||||TWO_SIDED|95.0|0.465|0.724|||||95% confidence interval for one proportion were estimated using the Exact (Clopper-Pearson) method.|||0.724|0.465|
72520537|NCT00789724|144570399|SUPERIORITY_OR_OTHER|||||||0.033||95.0|||||ANOVA|||||||0.033
72520538|NCT02088541|144570408|SUPERIORITY||Hazard Ratio (HR)|1.18||||0.4221|TWO_SIDED|95.0|0.79|1.75|||Log Rank|||||1.75|0.79|0.4221
72520539|NCT02088541|144570409|SUPERIORITY|||||||0.9464|||||||Log Rank|||||||0.9464
72520540|NCT02088541|144570410|SUPERIORITY|||||||0.0986|||||||Cochran-Mantel-Haenszel|||||||0.0986
72520541|NCT02088541|144570412|SUPERIORITY|||||||0.0844|||||||Cochran-Mantel-Haenszel|||||||0.0844
72520542|NCT01391468|144570441|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Chi-squared|||||||>0.05
72520543|NCT01391468|144570442|SUPERIORITY_OR_OTHER|||||||0.744|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.744
72520544|NCT01391468|144570443|SUPERIORITY_OR_OTHER|||||||0.0042|TWO_SIDED|||||Only the probiotics group arrived at the reported p-value after 6 months|Wilcoxon (Mann-Whitney)|||||||0.0042
72520545|NCT01391468|144570444|SUPERIORITY_OR_OTHER|||||||0.0099|TWO_SIDED|||||Only the probiotics group arrived at the reported p-value after 6 months|Wilcoxon (Mann-Whitney)|||||||0.0099
72624979|NCT02757768|144779457|SUPERIORITY|||||||0.5121|||||||t-test, 2 sided|Statistical comparisons were be made using 2-sided tests at α = 0.05 significance level.||EoT Placebo vs. Mirabegron.||||0.5121
72520546|NCT00608881|144570452|SUPERIORITY_OR_OTHER||π hat|0.494|||||TWO_SIDED|95.0|0.454|0.534|||||π hat is the estimate of the probability π that a randomly selected subject treated with CoQ has a better outcome than a randomly selected subject treated with placebo. Under the null hypothesis of no effect of CoQ, π = 0.50.|In this joint rank analysis, subjects are ranked from worst to best outcome with subjects who die being assigned the worst ranks (and ranked according to the time of death) and subjects who survive being ranked more favorably in the order of the change from baseline to Month 60 in TFC score.||0.534|0.454|
72520547|NCT00608881|144570453|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.23|||||TWO_SIDED|95.0|-0.44|0.91||||||||0.91|-0.44|
72520548|NCT00608881|144570454|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.09|||||TWO_SIDED|95.0|-1.4|1.58||||||||1.58|-1.40|
72520549|NCT00608881|144570455|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.44|||||TWO_SIDED|95.0|-6.68|3.79||||||||3.79|-6.68|
72520550|NCT00608881|144570456|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.12|||||TWO_SIDED|95.0|-4.4|2.16||||||||2.16|-4.40|
72369294|NCT00611026|144248567|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8|STANDARD_ERROR_OF_MEAN|0.6||0.1918|TWO_SIDED|95.0|-2.0|0.4|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and baseline value as a covariate.|Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.|Treatment difference Tolterodine ER vs placebo at Week 1.||0.4|-2.0|0.1918
72369295|NCT00611026|144248567|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|0.5||0.1505|TWO_SIDED|95.0|-1.7|0.3|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and baseline value as a covariate.|Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.|Treatment difference Tolterodine ER vs Fesoterodine at Week 1.||0.3|-1.7|0.1505
72520551|NCT00608881|144570457|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.04|||||TWO_SIDED|95.0|-1.48|1.39||||||||1.39|-1.48|
72520552|NCT00608881|144570458|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.77|||||TWO_SIDED|95.0|-4.78|3.23||||||||3.23|-4.78|
72369296|NCT00611026|144248567|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.9|STANDARD_ERROR_OF_MEAN|0.7|<|0.0001|TWO_SIDED|95.0|-5.2|-2.6|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and baseline value as a covariate.|Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.|Treatment difference fesoterodine vs placebo at Week 4.||-2.6|-5.2|<0.0001
72369297|NCT00611026|144248567|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.0|STANDARD_ERROR_OF_MEAN|0.7||0.0034|TWO_SIDED|95.0|-3.3|-0.7|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and baseline value as a covariate.|Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.|Treatment difference Tolterodine ER vs placebo at Week 4.||-0.7|-3.3|0.0034
72369298|NCT00611026|144248567|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.9|STANDARD_ERROR_OF_MEAN|0.5||0.0006|TWO_SIDED|95.0|-3.0|-0.8|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and baseline value as a covariate.|Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.|Treatment difference Tolterodine ER vs Fesoterodine at Week 4.||-0.8|-3.0|0.0006
72369299|NCT00611026|144248567|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.7|STANDARD_ERROR_OF_MEAN|0.7|<|0.0001|TWO_SIDED|95.0|-5.0|-2.3|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and baseline value as a covariate.|Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.|Treatment difference fesoterodine vs placebo at Week 12.||-2.3|-5.0|<0.0001
72369300|NCT00611026|144248567|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.2|STANDARD_ERROR_OF_MEAN|0.7||0.0859|TWO_SIDED|95.0|-2.5|0.2|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and baseline value as a covariate.|Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.|Treatment difference Tolterodine ER vs placebo at Week 12.||0.2|-2.5|0.0859
72369301|NCT00611026|144248567|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.5|STANDARD_ERROR_OF_MEAN|0.6|<|0.0001|TWO_SIDED|95.0|-3.6|-1.4|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and baseline value as a covariate.|Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.|Treatment difference Tolterodine ER vs Fesoterodine at Week 12.||-1.4|-3.6|<0.0001
72369302|NCT00611026|144248568|SUPERIORITY_OR_OTHER|||||||0.0008|TWO_SIDED||||||Cochran-Mantel-Haenszel|P-value based on Cochran-Mantel-Haenszel test stratified by baseline UUI quartile.||Treatment difference in continent rate for fesoterodine vs placebo at Week 1.||||0.0008
72369303|NCT00611026|144248568|SUPERIORITY_OR_OTHER|||||||0.0024|TWO_SIDED||||||Cochran-Mantel-Haenszel|P-value based on Cochran-Mantel-Haenszel test stratified by baseline UUI quartile.||Treatment difference in continent rate for Tolterodine ER vs placebo at Week 1.||||0.0024
72369304|NCT00611026|144248568|SUPERIORITY_OR_OTHER|||||||0.6514|TWO_SIDED||||||Cochran-Mantel-Haenszel|P-value based on Cochran-Mantel-Haenszel test stratified by baseline UUI quartile.||Treatment difference in continent rate for fesoterodine vs Tolterodine ER at Week 1.||||0.6514
72369305|NCT00611026|144248568|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|P-value based on Cochran-Mantel-Haenszel test stratified by baseline UUI quartile.||Treatment difference in continent rate for fesoterodine vs placebo at Week 4.||||<0.0001
72369306|NCT00611026|144248568|SUPERIORITY_OR_OTHER|||||||0.0063|TWO_SIDED||||||Cochran-Mantel-Haenszel|P-value based on Cochran-Mantel-Haenszel test stratified by baseline UUI quartile.||Treatment difference in continent rate for Tolterodine ER vs placebo at Week 4.||||0.0063
72369307|NCT00611026|144248568|SUPERIORITY_OR_OTHER|||||||0.0494|TWO_SIDED||||||Cochran-Mantel-Haenszel|P-value based on Cochran-Mantel-Haenszel test stratified by baseline UUI quartile.||Treatment difference in continent rate for fesoterodine vs Tolterodine ER at Week 4.||||0.0494
72405831|NCT01120210|144320146|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.35||||0.2123|TWO_SIDED|90.0|-4.164|1.464||one-sided p-value and one-sided alpha=0.05|ANCOVA|||90% confidence intervals and p values represent the placebo-subtracted LS mean change from baseline in pulmonary capillary wedge pressure (PCWP) at the end of the 15 ng/kg/min dose.||1.464|-4.164|0.2123
72405832|NCT01120210|144320146|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.58||||0.0821|TWO_SIDED|90.0|-5.639|0.483||one-sided p-value and one-sided alpha=0.05|ANCOVA|||90% confidence intervals and p values represent the placebo-subtracted LS mean change from baseline in pulmonary capillary wedge pressure (PCWP) at the end of the 30 ng/kg/min dose.||0.483|-5.639|0.0821
72405833|NCT01120210|144320147|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.32||||0.7682|TWO_SIDED|95.0|-2.527|1.879||two-sided p-value and two-sided alpha=0.05|ANCOVA|||95% confidence intervals and p values represent the placebo-subtracted LS mean change from baseline in heart rate (HR) at the end of the 5 ng/kg/min dose.||1.879|-2.527|0.7682
72405834|NCT01120210|144320147|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.24||||0.4107|TWO_SIDED|95.0|-1.764|4.235||two-sided p-value and two-sided alpha=0.05|ANCOVA|||95% confidence intervals and p values represent the placebo-subtracted LS mean change from baseline in heart rate (HR) at the end of the 15 ng/kg/min dose.||4.235|-1.764|0.4107
72520553|NCT00608881|144570459|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.41|||||TWO_SIDED|95.0|-1.32|2.14||||||||2.14|-1.32|
72520554|NCT00608881|144570460|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.6|||||TWO_SIDED|95.0|-2.71|1.51||||||||1.51|-2.71|
72520555|NCT00608881|144570461|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.29|||||TWO_SIDED|95.0|-2.28|2.87||||||||2.87|-2.28|
72520556|NCT00608881|144570462|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.88|||||TWO_SIDED|95.0|0.31|7.44||||||||7.44|0.31|
72520557|NCT00608881|144570463|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.04|||||TWO_SIDED|95.0|-1.1|3.18||||||||3.18|-1.10|
72569817|NCT02944383|144670010|SUPERIORITY|||||||0.1362||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.1362
72405835|NCT01120210|144320147|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.16||||0.1811|TWO_SIDED|95.0|-1.046|5.372||two-sided p-value and two-sided alpha=0.05|ANCOVA|||95% confidence intervals and p values represent the placebo-subtracted LS mean change from baseline in heart rate (HR) at the end of the 30 ng/kg/min dose.||5.372|-1.046|0.1811
72405836|NCT01120210|144320148|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.67||||0.803|TWO_SIDED|95.0|-6.06|4.718||two-sided p-value and two-sided alpha=0.05|ANCOVA|||95% confidence intervals and p values represent the placebo-subtracted LS mean change from baseline in systolic blood pressure (SBP) at the end of the 5 ng/kg/min dose.||4.718|-6.060|0.8030
72405837|NCT01120210|144320148|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.99||||0.4923|TWO_SIDED|95.0|-7.781|3.801||two-sided p-value and two-sided alpha=0.05|ANCOVA|||95% confidence intervals and p values represent the placebo-subtracted LS mean change from baseline in systolic blood pressure (SBP) at the end of the 15 ng/kg/min dose.||3.801|-7.781|0.4923
72405838|NCT01120210|144320148|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.77||||0.3152|TWO_SIDED|95.0|-11.251|3.708||two-sided p-value and two-sided alpha=0.05|ANCOVA|||95% confidence intervals and p values represent the placebo-subtracted LS mean change from baseline in systolic blood pressure (SBP) at the end of the 30 ng/kg/min dose.||3.708|-11.251|0.3152
72405839|NCT01120210|144320149|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.36||||0.1561||95.0|-8.047|1.331||two-sided p-value and two-sided alpha=0.05|ANCOVA|||95% confidence intervals and p values represent the placebo-subtracted LS mean change from baseline in diastolic blood pressure (DBP) at the end of the 5 ng/kg/min dose.||1.331|-8.047|0.1561
72405840|NCT01120210|144320149|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.55||||0.0282|TWO_SIDED|95.0|-10.482|-0.622||two-sided p-value and two-sided alpha=0.05|ANCOVA|||95% confidence intervals and p values represent the placebo-subtracted LS mean change from baseline in diastolic blood pressure (DBP) at the end of the 15 ng/kg/min dose.||-0.622|-10.482|0.0282
72520558|NCT00608881|144570464|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.99|||||TWO_SIDED|95.0|0.81|1.2||||||||1.20|0.81|
72520559|NCT00608881|144570465|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.93|||||TWO_SIDED|95.0|0.75|1.15||||||||1.15|0.75|
72520560|NCT00511108|144570491|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-29.7||||0.002||95.0|-48.7|-10.6|||ANCOVA|Model terms: treatment, prior diabetes pharmacotherapy (yes or no), and baseline value as a covariate||||-10.6|-48.7|0.002
72520561|NCT00511108|144570492|SUPERIORITY_OR_OTHER||Geometric Mean Difference|73.8|||<|0.001||95.0|44.2|104.4|||ANCOVA|Model terms: treatment, prior diabetes pharmacotherapy (yes or no), and log-scaled baseline value as a covariate|The outcome was analyzed by ANCOVA on the log scale. Results have been back-transformed to the original scale.|||104.4|44.2|<0.001
72520562|NCT00511108|144570493|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-407.8|||<|0.001||95.0|-513.4|-302.1|||ANCOVA|Model terms: treatment, prior diabetes pharmacotherapy (yes or no), and baseline value as a covariate||||-302.1|-513.4|<0.001
72520563|NCT04539262|144570522|SUPERIORITY||Least Square Mean Difference by Day 7|-0.66|STANDARD_ERROR_OF_MEAN|0.4||0.1117|TWO_SIDED|95.0|-1.49|0.16||Least square (LS) Mean, Standard Error (SE), 95% CI and p-value were from Analysis of covariance (ANCOVA) with baseline viral load as a covariate.|ANCOVA|||||0.16|-1.49|0.1117
72520564|NCT04539262|144570522|SUPERIORITY||LS Mean Difference by Day 7|-0.35|STANDARD_ERROR_OF_MEAN|0.4||0.3793|TWO_SIDED|95.0|-1.16|0.46||LS Mean (SE), 95% CI, and p-value were from ANCOVA with baseline viral load as a covariate.|ANCOVA|||||0.46|-1.16|0.3793
72520565|NCT04539262|144570522|SUPERIORITY||LS Mean Difference by Day 7|-0.24|STANDARD_ERROR_OF_MEAN|0.37||0.5248|TWO_SIDED|95.0|-1.0|0.52||LS Mean (SE), 95% CI, and p-value were from ANCOVA with baseline viral load as a covariate|ANCOVA|||||0.52|-1.00|0.5248
72520566|NCT04539262|144570522|SUPERIORITY||LS Mean Difference by Day 7|-0.25|STANDARD_ERROR_OF_MEAN|0.34||0.461|TWO_SIDED|95.0|-0.94|0.44|||ANCOVA|LS Mean (SE), 95% CI, and p-value were from ANCOVA with baseline viral load as a covariate||||0.44|-0.94|0.4610
72520567|NCT04539262|144570522|SUPERIORITY||LS Mean Difference by Day 7|0.2|STANDARD_ERROR_OF_MEAN|0.3||0.5006|TWO_SIDED|95.0|-0.4|0.81||LS Mean (SE), 95% CI and p-value were from ANCOVA with baseline viral load as a covariate.|ANCOVA|||||0.81|-0.40|0.5006
72405841|NCT01120210|144320149|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.08||||0.0043|TWO_SIDED|95.0|-11.818|-2.332||two-sided p-value and two-sided alpha=0.05|ANCOVA|||95% confidence intervals and p values represent the placebo-subtracted LS mean change from baseline in diastolic blood pressure (DBP) at the end of the 30 ng/kg/min dose.||-2.332|-11.818|0.0043
72520568|NCT04539262|144570523|SUPERIORITY||LS Mean Difference by Day 7|0.33|STANDARD_ERROR_OF_MEAN|0.34||0.3417|TWO_SIDED|95.0|-0.37|1.02||LS Mean (SE), 95% CI, and p-value were from ANCOVA with baseline viral load as a covariate.|ANCOVA|||||1.02|-0.37|0.3417
72520569|NCT04539262|144570523|SUPERIORITY||LS Mean Difference by Day 7|0.49|STANDARD_ERROR_OF_MEAN|0.35||0.1803|TWO_SIDED|95.0|-0.24|1.21||LS Mean (SE), 95% CI, and p-value were from ANCOVA with baseline viral load as a covariate.|ANCOVA|||||1.21|-0.24|0.1803
72520570|NCT04539262|144570523|SUPERIORITY||LS Mean Difference by Day 7|-0.55|STANDARD_ERROR_OF_MEAN|0.35||0.1233|TWO_SIDED|95.0|-1.27|0.16||LS Mean (SE), 95% CI, and p-value were from ANCOVA with baseline viral load as a covariate.|ANCOVA|||||0.16|-1.27|0.1233
72520571|NCT04539262|144570523|SUPERIORITY||LS Mean Difference by Day 7|0.08|STANDARD_ERROR_OF_MEAN|0.35||0.8203|TWO_SIDED|95.0|-0.64|0.8||LS Mean (SE), 95% CI, and p-value were from ANCOVA with baseline viral load as a covariate.|ANCOVA|||||0.80|-0.64|0.8203
72520572|NCT04539262|144570523|SUPERIORITY||LS Mean Difference by Day 7|-0.12|STANDARD_ERROR_OF_MEAN|0.26||0.6458|TWO_SIDED|95.0|-0.65|0.41||LS Mean (SE), 95% CI, and p-value were from ANCOVA with baseline viral load as a covariate.|ANCOVA|||||0.41|-0.65|0.6458
72520573|NCT04539262|144570524|SUPERIORITY||LS Mean Difference by Day 7|-0.22|STANDARD_ERROR_OF_MEAN|0.4||0.5951|TWO_SIDED|95.0|-1.05|0.61||LS Mean (SE), 95% CI, and p-value were from ANCOVA with baseline viral load as a covariate.|ANCOVA|||||0.61|-1.05|0.5951
72520574|NCT04539262|144570524|SUPERIORITY|LS Mean (SE), 95% CI, and p-value were from ANCOVA with baseline viral load as a covariate.|LS Mean Difference by Day 7|-0.71|STANDARD_ERROR_OF_MEAN|0.4||0.0872|TWO_SIDED|95.0|-1.54|0.11|||ANCOVA|||||0.11|-1.54|0.0872
72569818|NCT02944383|144670010|SUPERIORITY|||||||0.6458||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.6458
72405842|NCT01120210|144320150|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.24||||0.9769|TWO_SIDED|95.0|-16.347|16.823||two-sided p-value and two-sided alpha=0.05|ANCOVA|||95% confidence intervals and p values represent the placebo-subtracted LS mean change from baseline in left ventricular end systolic volume (LVESV) at the end of the 30 ng/kg/min dose.||16.823|-16.347|0.9769
72569819|NCT02944383|144670010|SUPERIORITY|||||||0.0209||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.0209
72569820|NCT02944383|144670010|SUPERIORITY|||||||0.0822||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.0822
72569821|NCT02944383|144670010|SUPERIORITY|||||||0.0504||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||EOS (average of week 10 and 12)||||0.0504
72569822|NCT02944383|144670010|SUPERIORITY|||||||0.1315||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||EOS (average of week 10 and 12)||||0.1315
72405843|NCT01120210|144320151|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.98||||0.8297|TWO_SIDED|95.0|-16.592|20.551||two-sided p-value and two-sided alpha=0.05|ANCOVA|||95% confidence intervals and p values represent the placebo-subtracted LS mean change from baseline in LVEDV at the end of the 30 ng/kg/min dose.||20.551|-16.592|0.8297
72405844|NCT01120210|144320152|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.31||||0.865|TWO_SIDED|95.0|-3.352|3.968||two-sided p-value and two-sided alpha=0.05|ANCOVA|||95% confidence intervals and p values represent the placebo-subtracted LS mean change from baseline in LVEF at the end of the 30 ng/kg/min dose.||3.968|-3.352|0.8650
72520575|NCT04539262|144570524|SUPERIORITY||LS Mean Difference by Day 7|-0.19|STANDARD_ERROR_OF_MEAN|0.36||0.6031|TWO_SIDED|95.0|-0.94|0.56||LS Mean (SE), 95% CI, and p-value were from ANCOVA with baseline viral load as a covariate.|ANCOVA|||||0.56|-0.94|0.6031
72520576|NCT04539262|144570524|SUPERIORITY||LS Mean Difference by Day 7|0.12|STANDARD_ERROR_OF_MEAN|0.37||0.7578|TWO_SIDED|95.0|-0.64|0.87||LS Mean (SE), 95% CI, and p-value were from ANCOVA with baseline viral load as a covariate.|ANCOVA|||||0.87|-0.64|0.7578
72520577|NCT04539262|144570524|SUPERIORITY||LS Mean Difference by Day 7|0.04|STANDARD_ERROR_OF_MEAN|0.26||0.8846|TWO_SIDED|95.0|-0.48|0.56||LS Mean (SE), 95% CI, and p-value were from ANCOVA with baseline viral load as a covariate.|ANCOVA|||||0.56|-0.48|0.8846
72520578|NCT02665468|144570557|SUPERIORITY|||||||0.01|||||||Chi-squared|||||||0.01
72520579|NCT00047853|144570581|OTHER||||||<|0.001|||||||ANOVA|||||||< 0.001
72520580|NCT00047853|144570582|OTHER|||||||9.3e-05|||||||t-test, 2 sided|||||||0.000093
72520581|NCT02443805|144570592|SUPERIORITY||||||<|0.0001||||||Source Model: Type III effects Covariates: Treatment group, Gender, Age Class, Sensitization Status, Asthma Status, Pooled Center, Baseline Average RTSS.|ANCOVA|||||||<0.0001
72520582|NCT04362813|144570595|SUPERIORITY||Odds Ratio (OR)|1.39||||0.2874|TWO_SIDED|95.0|0.76|2.54|||Regression, Logistic|||Odds ratio is based on a Logistic regression model adjusted by treatment, region (North America vs Europe), and baseline 9-point ordinal scale (\<=4, \>=5).||2.54|0.76|0.2874
72520583|NCT04362813|144570596|SUPERIORITY||Odds Ratio (OR)|0.67||||0.3303|TWO_SIDED|95.0|0.3|1.5|||Regression, Logistic|||Odds ratio is based on a Logistic regression model adjusted by treatment, region (North America vs Europe), and baseline 9-point ordinal scale (\<=4, \>=5)||1.50|0.30|0.3303
72520584|NCT00753688|144570604|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.35|||<|0.001|TWO_SIDED|95.0|0.26|0.48||Stratified two-sided log rank p-value|Log Rank||The HR was adjusted for World Health Organization (WHO) performance status scale (0 versus 1 at Baseline) and number of prior lines of systemic treatment for advanced disease (0/1 versus 2+).|||0.48|0.26|<0.001
72520585|NCT00753688|144570605|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.86||||0.256|TWO_SIDED|95.0|0.67|1.12||Stratified two-sided log rank p-value|Log Rank||The HR was adjusted for World Health Organization (WHO) performance status scale (0 versus 1 at Baseline) and number of prior lines of systemic treatment for advanced disease (0/1 versus 2+).|||1.12|0.67|0.256
72520586|NCT00753688|144570609|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.37|||<|0.001|TWO_SIDED|95.0|0.23|0.6||Stratified two-sided log rank p-value for leiomyosarcoma|Log Rank||The HR was adjusted for World Health Organization (WHO) performance status scale (0 versus 1 at Baseline) and number of prior lines of systemic treatment for advanced disease (0/1 versus 2+).|||0.60|0.23|<0.001
72520587|NCT00753688|144570609|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.43||||0.005|TWO_SIDED|95.0|0.19|0.98||Stratified two-sided log rank p-value for synovial sarcoma|Log Rank||The HR was adjusted for World Health Organization (WHO) performance status scale (0 versus 1 at Baseline) and number of prior lines of systemic treatment for advanced disease (0/1 versus 2+).|||0.98|0.19|0.005
72520588|NCT00753688|144570609|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.39|||<|0.001|TWO_SIDED|95.0|0.25|0.6||Stratified two-sided log rank p-value for other STS histologies|Log Rank||The HR was adjusted for World Health Organization (WHO) performance status scale (0 versus 1 at Baseline) and number of prior lines of systemic treatment for advanced disease (0/1 versus 2+).|||0.60|0.25|<0.001
72520589|NCT03803202|144570637|OTHER||Ratio of GMT|1.14|||||TWO_SIDED|95.0|0.7|1.85|||t-test, 2 sided|||Serotype 1, Day 1||1.85|0.70|
72520590|NCT03803202|144570637|OTHER||Ratio of GMT|1.17|||||TWO_SIDED|95.0|0.72|1.9|||t-test, 2 sided|||Serotype 1, Day 1||1.90|0.72|
72520591|NCT03803202|144570637|OTHER||Ratio of GMT|1.17|||||TWO_SIDED|95.0|0.74|1.87|||t-test, 2 sided|||Serotype 1, Day 1||1.87|0.74|
72520592|NCT03803202|144570637|OTHER||Ratio of GMT|1.57|||||TWO_SIDED|95.0|0.68|3.63|||t-test, 2 sided|||Serotype 3, Day 1||3.63|0.68|
72520593|NCT03803202|144570637|OTHER||Ratio of GMT|2.04|||||TWO_SIDED|95.0|0.86|4.82|||t-test, 2 sided|||Serotype 3, Day 1||4.82|0.86|
72520594|NCT03803202|144570637|OTHER||Ratio of GMT|0.67|||||TWO_SIDED|95.0|0.31|1.46|||t-test, 2 sided|||Serotype 3, Day 1||1.46|0.31|
72569823|NCT02944383|144670011|SUPERIORITY|||||||0.0843||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.0843
72569824|NCT02944383|144670011|SUPERIORITY|||||||0.3587||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.3587
72569825|NCT02944383|144670011|SUPERIORITY||Median Difference (Net)|12.99||||0.0843|TWO_SIDED|95.0|-0.54|25.51||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|EOS (average of week 10 and 12)||25.51|-0.54|0.0843
72569826|NCT02944383|144670011|SUPERIORITY||Median Difference (Net)|7.98||||0.3587|TWO_SIDED|95.0|-3.7|21.39||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|EOS (average of week 10 and 12)||21.39|-3.70|0.3587
72569827|NCT02944383|144670012|SUPERIORITY|||||||0.0768||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.0768
72569828|NCT02944383|144670012|SUPERIORITY|||||||0.4346||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.4346
72569829|NCT02944383|144670012|SUPERIORITY|||||||0.0768||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||EOS (average of week 10 and 12)||||0.0768
72569830|NCT02944383|144670012|SUPERIORITY|||||||0.4346||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||EOS (average of week 10 and 12)||||0.4346
72569831|NCT02944383|144670013|SUPERIORITY|||||||0.5411||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.5411
72520595|NCT03803202|144570637|OTHER||Ratio of GMT|1.11|||||TWO_SIDED|95.0|0.27|4.55|||t-test, 2 sided|||Serotype 4, Day 1||4.55|0.27|
72520596|NCT03803202|144570637|OTHER||Ratio of GMT|0.7|||||TWO_SIDED|95.0|0.19|2.61|||t-test, 2 sided|||Serotype 4, Day 1||2.61|0.19|
72520597|NCT03803202|144570637|OTHER||Ratio of GMT|1.83|||||TWO_SIDED|95.0|0.49|6.85|||t-test, 2 sided|||Serotype 4, Day 1||6.85|0.49|
72520598|NCT03803202|144570637|OTHER||Ratio of GMT|1.9|||||TWO_SIDED|95.0|0.76|4.73|||t-test, 2 sided|||Serotype 5, Day 1||4.73|0.76|
72520599|NCT03803202|144570637|OTHER||Ratio of GMT|1.22|||||TWO_SIDED|95.0|0.62|2.4|||t-test, 2 sided|||Serotype 5, Day 1||2.40|0.62|
72520600|NCT03803202|144570637|OTHER||Ratio of GMT|0.93|||||TWO_SIDED|95.0|0.52|1.65|||t-test, 2 sided|||Serotype 5, Day 1||1.65|0.52|
72520601|NCT03803202|144570637|OTHER||Ratio of GMT|0.84|||||TWO_SIDED|95.0|0.25|2.82|||t-test, 2 sided|||Serotype 6A, Day 1||2.82|0.25|
72520602|NCT03803202|144570637|OTHER||Ratio of GMT|0.73|||||TWO_SIDED|95.0|0.24|2.23|||t-test, 2 sided|||Serotype 6A, Day 1||2.23|0.24|
72520603|NCT03803202|144570637|OTHER||Ratio of GMT|1.03|||||TWO_SIDED|95.0|0.31|3.41|||t-test, 2 sided|||Serotype 6A, Day 1||3.41|0.31|
72520604|NCT03803202|144570637|OTHER||Ratio of GMT|1.19|||||TWO_SIDED|95.0|0.32|4.46|||t-test, 2 sided|||Serotype 6B,Day 1||4.46|0.32|
72520605|NCT03803202|144570637|OTHER||Ratio of GMT|1.3|||||TWO_SIDED|95.0|0.42|4.05|||t-test, 2 sided|||Serotype 6B, Day 1||4.05|0.42|
72520606|NCT03803202|144570637|OTHER||Ratio of GMT|0.71|||||TWO_SIDED|95.0|0.24|2.14|||t-test, 2 sided|||Serotype 6B, Day 1||2.14|0.24|
72520607|NCT03803202|144570637|OTHER||Ratio of GMT|0.76|||||TWO_SIDED|95.0|0.26|2.17|||t-test, 2 sided|||Serotype 7F, Day 1||2.17|0.26|
72520608|NCT03803202|144570637|OTHER||Ratio of GMT|0.32|||||TWO_SIDED|95.0|0.11|0.89|||t-test, 2 sided|||Serotype 7F, Day 1||0.89|0.11|
72520609|NCT03803202|144570637|OTHER||Ratio of GMT|0.31|||||TWO_SIDED|95.0|0.1|0.93|||t-test, 2 sided|||Serotype 7F, Day 1||0.93|0.10|
72520610|NCT03803202|144570637|OTHER||Ratio of GMT|1.92|||||TWO_SIDED|95.0|0.74|4.99|||t-test, 2 sided|||Serotype 9V, Day 1||4.99|0.74|
72520611|NCT03803202|144570637|OTHER||Ratio of GMT|0.48|||||TWO_SIDED|95.0|0.15|1.61|||t-test, 2 sided|||Serotype 9V, Day 1||1.61|0.15|
72520612|NCT03803202|144570637|OTHER||Ratio of GMT|0.62|||||TWO_SIDED|95.0|0.21|1.9|||t-test, 2 sided|||Serotype 9V, Day 1||1.90|0.21|
72520613|NCT03803202|144570637|OTHER||Ratio of GMT|4.2|||||TWO_SIDED|95.0|1.17|15.09|||t-test, 2 sided|||Serotype 14, Day 1||15.09|1.17|
72520614|NCT03803202|144570637|OTHER||Ratio of GMT|1.91|||||TWO_SIDED|95.0|0.52|7.07|||t-test, 2 sided|||Serotype 14, Day 1||7.07|0.52|
72520615|NCT03803202|144570637|OTHER||Ratio of GMT|0.98|||||TWO_SIDED|95.0|0.23|4.25|||t-test, 2 sided|||Serotype 14, Day 1||4.25|0.23|
72520616|NCT03803202|144570637|OTHER||Ratio of GMT|0.74|||||TWO_SIDED|95.0|0.21|2.62|||t-test, 2 sided|||Serotype 18C, Day 1||2.62|0.21|
72520617|NCT03803202|144570637|OTHER||Ratio of GMT|1.19|||||TWO_SIDED|95.0|0.37|3.77|||t-test, 2 sided|||Serotype 18C, Day 1||3.77|0.37|
72520618|NCT03803202|144570637|OTHER||Ratio of GMT|1.22|||||TWO_SIDED|95.0|0.38|3.94|||t-test, 2 sided|||Serotype 18C, Day 1||3.94|0.38|
72520619|NCT03803202|144570637|OTHER||Ratio of GMT|1.11|||||TWO_SIDED|95.0|0.51|2.45|||t-test, 2 sided|||Serotype 19A, Day 1||2.45|0.51|
72520620|NCT03803202|144570637|OTHER||Ratio of GMT|0.71|||||TWO_SIDED|95.0|0.31|1.63|||t-test, 2 sided|||Serotype 19A, Day 1||1.63|0.31|
72520621|NCT03803202|144570637|OTHER||Ratio of GMT|0.74|||||TWO_SIDED|95.0|0.36|1.53|||t-test, 2 sided|||Serotype 19A, Day 1||1.53|0.36|
72520622|NCT03803202|144570637|OTHER||Ratio of GMT|0.7|||||TWO_SIDED|95.0|0.24|2.08|||t-test, 2 sided|||Serotype 19F, Day 1||2.08|0.24|
72520623|NCT03803202|144570637|OTHER||Ratio of GMT|1.24|||||TWO_SIDED|95.0|0.44|3.5|||t-test, 2 sided|||Serotype 19F, Day 1||3.50|0.44|
72520624|NCT03803202|144570637|OTHER||Ratio of GMT|1.45|||||TWO_SIDED|95.0|0.58|3.61|||t-test, 2 sided|||Serotype 19F, Day 1||3.61|0.58|
72520625|NCT03803202|144570637|OTHER||Ratio of GMT|2.22|||||TWO_SIDED|95.0|0.46|10.69|||t-test, 2 sided|||Serotype 23F, Day 1||10.69|0.46|
72520626|NCT03803202|144570637|OTHER||Ratio of GMT|1.36|||||TWO_SIDED|95.0|0.31|5.99|||t-test, 2 sided|||Serotype 23F, Day 1||5.99|0.31|
72520627|NCT03803202|144570637|OTHER||Ratio of GMT|0.67|||||TWO_SIDED|95.0|0.15|3.01|||t-test, 2 sided|||Serotype 23F, Day 1||3.01|0.15|
72569832|NCT02944383|144670013|SUPERIORITY|||||||0.2574||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.2574
72569833|NCT02944383|144670013|SUPERIORITY||Median Difference (Net)|3.11||||0.5411|TWO_SIDED|95.0|-9.59|14.86||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|EOS (average of week 10 and 12)||14.86|-9.59|0.5411
72520628|NCT03803202|144570637|OTHER||Ratio of GMT|0.93|||||TWO_SIDED|95.0|0.5|1.74|||t-test, 2 sided|||Serotype 1, Day 30||1.74|0.50|
72520629|NCT03803202|144570637|OTHER||Ratio of GMT|0.72|||||TWO_SIDED|95.0|0.39|1.32|||t-test, 2 sided|||Serotype 1, Day 30||1.32|0.39|
72520630|NCT03803202|144570637|OTHER||Ratio of GMT|0.7|||||TWO_SIDED|95.0|0.35|1.39|||t-test, 2 sided|||Serotype 1, Day 30||1.39|0.35|
72520631|NCT03803202|144570637|OTHER||Ratio of GMT|1.09|||||TWO_SIDED|95.0|0.66|1.8|||t-test, 2 sided|||Serotype 3, Day 30||1.80|0.66|
72520632|NCT03803202|144570637|OTHER||Ratio of GMT|1.44|||||TWO_SIDED|95.0|0.9|2.29|||t-test, 2 sided|||Serotype 3, Day 30||2.29|0.90|
72520633|NCT03803202|144570637|OTHER||Ratio of GMT|1.28|||||TWO_SIDED|95.0|0.76|2.17|||t-test, 2 sided|||Serotype 3, Day 30||2.17|0.76|
72520634|NCT03803202|144570637|OTHER||Ratio of GMT|0.82|||||TWO_SIDED|95.0|0.5|1.35|||t-test, 2 sided|||Serotype 4, Day 30||1.35|0.50|
72520635|NCT03803202|144570637|OTHER||Ratio of GMT|0.5|||||TWO_SIDED|95.0|0.24|1.02|||t-test, 2 sided|||Serotype 4, Day 30||1.02|0.24|
72520636|NCT03803202|144570637|OTHER||Ratio of GMT|1.06|||||TWO_SIDED|95.0|0.6|1.89|||t-test, 2 sided|||Serotype 4, Day 30||1.89|0.60|
72520637|NCT03803202|144570637|OTHER||Ratio of GMT|0.69|||||TWO_SIDED|95.0|0.41|1.15|||t-test, 2 sided|||Serotype 5, Day 30||1.15|0.41|
72520638|NCT03803202|144570637|OTHER||Ratio of GMT|0.61|||||TWO_SIDED|95.0|0.31|1.2|||t-test, 2 sided|||Serotype 5, Day 30||1.20|0.31|
72520639|NCT03803202|144570637|OTHER||Ratio of GMT|0.8|||||TWO_SIDED|95.0|0.48|1.32|||t-test, 2 sided|||Serotype 5, Day 30||1.32|0.48|
72520640|NCT03803202|144570637|OTHER||Ratio of GMT|0.52|||||TWO_SIDED|95.0|0.28|0.98|||t-test, 2 sided|||Serotype 6A, Day 30||0.98|0.28|
72520641|NCT03803202|144570637|OTHER||Ratio of GMT|0.32|||||TWO_SIDED|95.0|0.15|0.68|||t-test, 2 sided|||Serotype 6A, Day 30||0.68|0.15|
72520642|NCT03803202|144570637|OTHER||Ratio of GMT|0.37|||||TWO_SIDED|95.0|0.21|0.66|||t-test, 2 sided|||Serotype 6A, Day 30||0.66|0.21|
72520643|NCT03803202|144570637|OTHER||Ratio of GMT|0.7|||||TWO_SIDED|95.0|0.42|1.18|||t-test, 2 sided|||Serotype 6B, Day 30||1.18|0.42|
72520644|NCT03803202|144570637|OTHER||Ratio of GMT|0.45|||||TWO_SIDED|95.0|0.25|0.83|||t-test, 2 sided|||Serotype 6B, Day 30||0.83|0.25|
72520645|NCT03803202|144570637|OTHER||Ratio of GMT|0.43|||||TWO_SIDED|95.0|0.24|0.76|||t-test, 2 sided|||Serotype 6B, Day 30||0.76|0.24|
72520646|NCT03803202|144570637|OTHER||Ratio of GMT|0.81|||||TWO_SIDED|95.0|0.51|1.29|||t-test, 2 sided|||Serotype 7F, Day 30||1.29|0.51|
72520647|NCT03803202|144570637|OTHER||Ratio of GMT|0.68|||||TWO_SIDED|95.0|0.47|0.99|||t-test, 2 sided|||Serotype 7F, Day 30||0.99|0.47|
72520648|NCT03803202|144570637|OTHER||Ratio of GMT|0.82|||||TWO_SIDED|95.0|0.53|1.25|||t-test, 2 sided|||Serotype 7F, Day 30||1.25|0.53|
72520649|NCT03803202|144570637|OTHER||Ratio of GMT|0.61|||||TWO_SIDED|95.0|0.35|1.08|||t-test, 2 sided|||Serotype 9V, Day 30||1.08|0.35|
72520650|NCT03803202|144570637|OTHER||Ratio of GMT|0.57|||||TWO_SIDED|95.0|0.31|1.03|||t-test, 2 sided|||Serotype 9V, Day 30||1.03|0.31|
72520651|NCT03803202|144570637|OTHER||Ratio of GMT|0.77|||||TWO_SIDED|95.0|0.46|1.28|||t-test, 2 sided|||Serotype 9V, Day 30||1.28|0.46|
72520652|NCT03803202|144570637|OTHER||Ratio of GMT|0.54|||||TWO_SIDED|95.0|0.27|1.08|||t-test, 2 sided|||Serotype 14, Day 30||1.08|0.27|
72520653|NCT03803202|144570637|OTHER||Ratio of GMT|0.28|||||TWO_SIDED|95.0|0.1|0.77|||t-test, 2 sided|||Serotype 14, Day 30||0.77|0.10|
72520654|NCT03803202|144570637|OTHER||Ratio of GMT|1.13|||||TWO_SIDED|95.0|0.56|2.3|||t-test, 2 sided|||Serotype 14, Day 30||2.30|0.56|
72520655|NCT03803202|144570637|OTHER||Ratio of GMT|0.89|||||TWO_SIDED|95.0|0.53|1.5|||t-test, 2 sided|||Serotype 18C, Day 30||1.50|0.53|
72520656|NCT03803202|144570637|OTHER||Ratio of GMT|0.69|||||TWO_SIDED|95.0|0.39|1.23|||t-test, 2 sided|||Serotype 18C, Day 30||1.23|0.39|
72520657|NCT03803202|144570637|OTHER||Ratio of GMT|0.8|||||TWO_SIDED|95.0|0.5|1.28|||t-test, 2 sided|||Serotype 18C, Day 30||1.28|0.50|
72520658|NCT03803202|144570637|OTHER||Ratio of GMT|0.5|||||TWO_SIDED|95.0|0.32|0.79|||t-test, 2 sided|||Serotype 19A, Day 30||0.79|0.32|
72520659|NCT03803202|144570637|OTHER||Ratio of GMT|0.7|||||TWO_SIDED|95.0|0.45|1.09|||t-test, 2 sided|||Serotype 19A, Day 30||1.09|0.45|
72520660|NCT03803202|144570637|OTHER||Ratio of GMT|0.63|||||TWO_SIDED|95.0|0.42|0.96|||t-test, 2 sided|||Serotype 19A, Day 30||0.96|0.42|
72520661|NCT03803202|144570637|OTHER||Ratio of GMT|0.56|||||TWO_SIDED|95.0|0.34|0.92|||t-test, 2 sided|||Serotype 19F, Day 30||0.92|0.34|
72520662|NCT03803202|144570637|OTHER||Ratio of GMT|0.64|||||TWO_SIDED|95.0|0.37|1.1|||t-test, 2 sided|||Serotype 19F, Day 30||1.10|0.37|
72520663|NCT03803202|144570637|OTHER||Ratio of GMT|0.93|||||TWO_SIDED|95.0|0.56|1.55|||t-test, 2 sided|||Serotype 19F, Day 30||1.55|0.56|
72520664|NCT03803202|144570637|OTHER||Ratio of GMT|0.2|||||TWO_SIDED|95.0|0.08|0.46|||t-test, 2 sided|||Serotype 23F, Day 30||0.46|0.08|
72520665|NCT03803202|144570637|OTHER||Ratio of GMT|0.2|||||TWO_SIDED|95.0|0.08|0.47|||t-test, 2 sided|||Serotype 23F, Day 30||0.47|0.08|
72569834|NCT02944383|144670013|SUPERIORITY||Median Difference (Net)|-7.31||||0.2574|TWO_SIDED|95.0|-19.3|5.76||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|EOS (average of week 10 and 12)||5.76|-19.30|0.2574
72520666|NCT03803202|144570637|OTHER||Ratio of GMT|0.23|||||TWO_SIDED|95.0|0.09|0.57|||t-test, 2 sided|||Serotype 23F, Day 30||0.57|0.09|
72520667|NCT03803202|144570638|OTHER||Ratio of GMC|1.08|||||TWO_SIDED|95.0|0.52|2.23|||t-test, 2 sided|||Serotype 1, Day 1||2.23|0.52|
72520668|NCT03803202|144570638|OTHER||Ratio of GMC|1.0|||||TWO_SIDED|95.0|0.51|1.98|||t-test, 2 sided|||Serotype 1, Day 1||1.98|0.51|
72520669|NCT03803202|144570638|OTHER||Ratio of GMC|1.43|||||TWO_SIDED|95.0|0.72|2.83|||t-test, 2 sided|||Serotype 1, Day 1||2.83|0.72|
72520670|NCT03803202|144570638|OTHER||Ratio of GMC|1.26|||||TWO_SIDED|95.0|0.59|2.68|||t-test, 2 sided|||Serotype 3, Day 1||2.68|0.59|
72520671|NCT03803202|144570638|OTHER||Ratio of GMC|1.65|||||TWO_SIDED|95.0|0.9|3.05|||t-test, 2 sided|||Serotype 3, Day 1||3.05|0.90|
72520672|NCT03803202|144570638|OTHER||Ratio of GMC|1.24|||||TWO_SIDED|95.0|0.68|2.25|||t-test, 2 sided|||Serotype 3, Day 1||2.25|0.68|
72520673|NCT03803202|144570638|OTHER||Ratio of GMC|1.03|||||TWO_SIDED|95.0|0.49|2.15|||t-test, 2 sided|||Serotype 4, Day 1||2.15|0.49|
72520674|NCT03803202|144570638|OTHER||Ratio of GMC|0.82|||||TWO_SIDED|95.0|0.39|1.74|||t-test, 2 sided|||Serotype 4, Day 1||1.74|0.39|
72520675|NCT03803202|144570638|OTHER||Ratio of GMC|1.24|||||TWO_SIDED|95.0|0.59|2.59|||t-test, 2 sided|||Serotype 4, Day 1||2.59|0.59|
72520676|NCT03803202|144570638|OTHER||Ratio of GMC|1.71|||||TWO_SIDED|95.0|0.75|3.91|||t-test, 2 sided|||Serotype 5, Day 1||3.91|0.75|
72520677|NCT03803202|144570638|OTHER||Ratio of GMC|0.72|||||TWO_SIDED|95.0|0.36|1.46|||t-test, 2 sided|||Serotype 5, Day 1||1.46|0.36|
72520678|NCT03803202|144570638|OTHER||Ratio of GMC|0.93|||||TWO_SIDED|95.0|0.47|1.84|||t-test, 2 sided|||Serotype 5, Day 1||1.84|0.47|
72520679|NCT03803202|144570638|OTHER||Ratio of GMC|1.19|||||TWO_SIDED|95.0|0.57|2.52|||t-test, 2 sided|||Serotype 6A, Day 1||2.52|0.57|
72520680|NCT03803202|144570638|OTHER||Ratio of GMC|1.28|||||TWO_SIDED|95.0|0.64|2.56|||t-test, 2 sided|||Serotype 6A, Day 1||2.56|0.64|
72520681|NCT03803202|144570638|OTHER||Ratio of GMC|1.09|||||TWO_SIDED|95.0|0.52|2.28|||t-test, 2 sided|||Serotype 6A, Day 1||2.28|0.52|
72520682|NCT03803202|144570638|OTHER||Ratio of GMC|1.23|||||TWO_SIDED|95.0|0.49|3.09|||t-test, 2 sided|||Serotype 6B, Day 1||3.09|0.49|
72520683|NCT03803202|144570638|OTHER||Ratio of GMC|0.96|||||TWO_SIDED|95.0|0.43|2.14|||t-test, 2 sided|||Serotype 6B, Day 1||2.14|0.43|
72520684|NCT03803202|144570638|OTHER||Ratio of GMC|0.81|||||TWO_SIDED|95.0|0.37|1.73|||t-test, 2 sided|||Serotype 6B, Day 1||1.73|0.37|
72520685|NCT03803202|144570638|OTHER||Ratio of GMC|1.51|||||TWO_SIDED|95.0|0.76|3.01|||t-test, 2 sided|||Serotype 7F, Day 1||3.01|0.76|
72520686|NCT03803202|144570638|OTHER||Ratio of GMC|1.16|||||TWO_SIDED|95.0|0.69|1.94|||t-test, 2 sided|||Serotype 7F, Day 1||1.94|0.69|
72520687|NCT03803202|144570638|OTHER||Ratio of GMC|1.69|||||TWO_SIDED|95.0|0.98|2.91|||t-test, 2 sided|||Serotype 7F, Day 1||2.91|0.98|
72520688|NCT03803202|144570638|OTHER||Ratio of GMC|1.09|||||TWO_SIDED|95.0|0.54|2.22|||t-test, 2 sided|||Serotype 9V, Day 1||2.22|0.54|
72520689|NCT03803202|144570638|OTHER||Ratio of GMC|0.74|||||TWO_SIDED|95.0|0.41|1.36|||t-test, 2 sided|||Serotype 9V, Day 1||1.36|0.41|
72520690|NCT03803202|144570638|OTHER||Ratio of GMC|0.85|||||TWO_SIDED|95.0|0.47|1.55|||t-test, 2 sided|||Serotype 9V, Day 1||1.55|0.47|
72520691|NCT03803202|144570638|OTHER||Ratio of GMC|2.05|||||TWO_SIDED|95.0|0.84|4.99|||t-test, 2 sided|||Serotype 14, Day 1||4.99|0.84|
72520692|NCT03803202|144570638|OTHER||Ratio of GMC|2.6|||||TWO_SIDED|95.0|1.13|5.98|||t-test, 2 sided|||Serotype 14, Day 1||5.98|1.13|
72520693|NCT03803202|144570638|OTHER||Ratio of GMC|0.89|||||TWO_SIDED|95.0|0.37|2.15|||t-test, 2 sided|||Serotype 14, Day 1||2.15|0.37|
72520694|NCT03803202|144570638|OTHER||Ratio of GMC|1.37|||||TWO_SIDED|95.0|0.61|3.06|||t-test, 2 sided|||Serotype 18C, Day 1||3.06|0.61|
72520695|NCT03803202|144570638|OTHER||Ratio of GMC|1.07|||||TWO_SIDED|95.0|0.55|2.09|||t-test, 2 sided|||Serotype 18C, Day 1||2.09|0.55|
72520696|NCT03803202|144570638|OTHER||Ratio of GMC|1.25|||||TWO_SIDED|95.0|0.59|2.65|||t-test, 2 sided|||Serotype 18C, Day 1||2.65|0.59|
72520697|NCT03803202|144570638|OTHER||Ratio of GMC|1.61|||||TWO_SIDED|95.0|0.74|3.49|||t-test, 2 sided|||Serotype 19A, Day 1||3.49|0.74|
72520698|NCT03803202|144570638|OTHER||Ratio of GMC|0.83|||||TWO_SIDED|95.0|0.42|1.65|||t-test, 2 sided|||Serotype 19A, Day 1||1.65|0.42|
72520699|NCT03803202|144570638|OTHER||Ratio of GMC|1.0|||||TWO_SIDED|95.0|0.49|2.05|||t-test, 2 sided|||Serotype 19A, Day 1||2.05|0.49|
72520700|NCT03803202|144570638|OTHER||Ratio of GMC|1.47|||||TWO_SIDED|95.0|0.63|3.39|||t-test, 2 sided|||Serotype 19F, Day 1||3.39|0.63|
72520701|NCT03803202|144570638|OTHER||Ratio of GMC|1.4|||||TWO_SIDED|95.0|0.64|3.07|||t-test, 2 sided|||Serotype 19F, Day 1||3.07|0.64|
72520702|NCT03803202|144570638|OTHER||Ratio of GMC|1.12|||||TWO_SIDED|95.0|0.53|2.34|||t-test, 2 sided|||Serotype 19F, Day 1||2.34|0.53|
72520703|NCT03803202|144570638|OTHER||Ratio of GMC|1.01|||||TWO_SIDED|95.0|0.49|2.09|||t-test, 2 sided|||Serotype 23F, Day 1||2.09|0.49|
72520704|NCT03803202|144570638|OTHER||Ratio of GMC|0.94|||||TWO_SIDED|95.0|0.5|1.75|||t-test, 2 sided|||Serotype 23F, Day 1||1.75|0.50|
72520705|NCT03803202|144570638|OTHER||Ratio of GMC|0.91|||||TWO_SIDED|95.0|0.42|2.0|||t-test, 2 sided|||Serotype 23F, Day 1||2.00|0.42|
72520706|NCT03803202|144570638|OTHER||Ratio of GMC|0.7|||||TWO_SIDED|95.0|0.38|1.29|||t-test, 2 sided|||Serotype 1, Day 30||1.29|0.38|
72520707|NCT03803202|144570638|OTHER||Ratio of GMC|0.95|||||TWO_SIDED|95.0|0.52|1.73|||t-test, 2 sided|||Serotype 1, Day 30||1.73|0.52|
72520708|NCT03803202|144570638|OTHER||Ratio of GMC|1.5|||||TWO_SIDED|95.0|0.84|2.66|||t-test, 2 sided|||Serotype 1, Day 30||2.66|0.84|
72520709|NCT03803202|144570638|OTHER||Ratio of GMC|1.38|||||TWO_SIDED|95.0|0.84|2.28|||t-test, 2 sided|||Serotype 3, Day 30||2.28|0.84|
72520710|NCT03803202|144570638|OTHER||Ratio of GMC|2.68|||||TWO_SIDED|95.0|1.71|4.19|||t-test, 2 sided|||Serotype 3, Day 30||4.19|1.71|
72520711|NCT03803202|144570638|OTHER||Ratio of GMC|3.87|||||TWO_SIDED|95.0|2.47|6.06|||t-test, 2 sided|||Serotype 3, Day 30||6.06|2.47|
72520712|NCT03803202|144570638|OTHER||Ratio of GMC|1.27|||||TWO_SIDED|95.0|0.7|2.3|||t-test, 2 sided|||Serotype 4, Day 30||2.30|0.70|
72520713|NCT03803202|144570638|OTHER||Ratio of GMC|1.02|||||TWO_SIDED|95.0|0.57|1.81|||t-test, 2 sided|||Serotype 4, Day 30||1.81|0.57|
72520714|NCT03803202|144570638|OTHER||Ratio of GMC|2.24|||||TWO_SIDED|95.0|1.21|4.15|||t-test, 2 sided|||Serotype 4, Day 30||4.15|1.21|
72520715|NCT03803202|144570638|OTHER||Ratio of GMC|1.58|||||TWO_SIDED|95.0|0.7|3.57|||t-test, 2 sided|||Serotype 5, Day 30||3.57|0.70|
72520716|NCT03803202|144570638|OTHER||Ratio of GMC|0.84|||||TWO_SIDED|95.0|0.35|2.05|||t-test, 2 sided|||Serotype 5, Day 30||2.05|0.35|
72520717|NCT03803202|144570638|OTHER||Ratio of GMC|1.49|||||TWO_SIDED|95.0|0.65|3.39|||t-test, 2 sided|||Serotype 5, Day 30||3.39|0.65|
72520718|NCT03803202|144570638|OTHER||Ratio of GMC|0.89|||||TWO_SIDED|95.0|0.41|1.93|||t-test, 2 sided|||Serotype 6A, Day 30||1.93|0.41|
72520719|NCT03803202|144570638|OTHER||Ratio of GMC|0.77|||||TWO_SIDED|95.0|0.33|1.79|||t-test, 2 sided|||Serotype 6A, Day 30||1.79|0.33|
72520720|NCT03803202|144570638|OTHER||Ratio of GMC|0.69|||||TWO_SIDED|95.0|0.32|1.48|||t-test, 2 sided|||Serotype 6A, Day 30||1.48|0.32|
72520721|NCT03803202|144570638|OTHER||Ratio of GMC|1.26|||||TWO_SIDED|95.0|0.57|2.83|||t-test, 2 sided|||Serotype 6B, Day 30||2.83|0.57|
72520722|NCT03803202|144570638|OTHER||Ratio of GMC|0.75|||||TWO_SIDED|95.0|0.31|1.81|||t-test, 2 sided|||Serotype 6B, Day 30||1.81|0.31|
72520723|NCT03803202|144570638|OTHER||Ratio of GMC|0.88|||||TWO_SIDED|95.0|0.39|1.97|||t-test, 2 sided|||Serotype 6B, Day 30||1.97|0.39|
72520724|NCT03803202|144570638|OTHER||Ratio of GMC|1.86|||||TWO_SIDED|95.0|1.05|3.3|||t-test, 2 sided|||Serotype 7F, Day 30||3.30|1.05|
72520725|NCT03803202|144570638|OTHER||Ratio of GMC|1.98|||||TWO_SIDED|95.0|1.1|3.55|||t-test, 2 sided|||Serotype 7F, Day 30||3.55|1.10|
72520726|NCT03803202|144570638|OTHER||Ratio of GMC|2.88|||||TWO_SIDED|95.0|1.62|5.12|||t-test, 2 sided|||Serotype 7F, Day 30||5.12|1.62|
72520727|NCT03803202|144570638|OTHER||Ratio of GMC|0.96|||||TWO_SIDED|95.0|0.49|1.87|||t-test, 2 sided|||Serotype 9V, Day 30||1.87|0.49|
72520728|NCT03803202|144570638|OTHER||Ratio of GMC|1.39|||||TWO_SIDED|95.0|0.74|2.62|||t-test, 2 sided|||Serotype 9V, Day 30||2.62|0.74|
72520729|NCT03803202|144570638|OTHER||Ratio of GMC|1.68|||||TWO_SIDED|95.0|0.87|3.27|||t-test, 2 sided|||Serotype 9V, Day 30||3.27|0.87|
72520730|NCT03803202|144570638|OTHER||Ratio of GMC|1.01|||||TWO_SIDED|95.0|0.41|2.53|||t-test, 2 sided|||Serotype 14, Day 30||2.53|0.41|
72520731|NCT03803202|144570638|OTHER||Ratio of GMC|1.08|||||TWO_SIDED|95.0|0.45|2.6|||t-test, 2 sided|||Serotype 14, Day 30||2.60|0.45|
72520732|NCT03803202|144570638|OTHER||Ratio of GMC|2.09|||||TWO_SIDED|95.0|0.86|5.04|||t-test, 2 sided|||Serotype 14, Day 30||5.04|0.86|
72520733|NCT03803202|144570638|OTHER||Ratio of GMC|1.09|||||TWO_SIDED|95.0|0.57|2.07|||t-test, 2 sided|||Serotype 18C, Day 30||2.07|0.57|
72520734|NCT03803202|144570638|OTHER||Ratio of GMC|1.0|||||TWO_SIDED|95.0|0.53|1.89|||t-test, 2 sided|||Serotype 18C, Day 30||1.89|0.53|
72520735|NCT03803202|144570638|OTHER||Ratio of GMC|1.08|||||TWO_SIDED|95.0|0.56|2.07|||t-test, 2 sided|||Serotype 18C, Day 30||2.07|0.56|
72520736|NCT03803202|144570638|OTHER||Ratio of GMC|0.68|||||TWO_SIDED|95.0|0.4|1.14|||t-test, 2 sided|||Serotype 19A, Day 30||1.14|0.40|
72520737|NCT03803202|144570638|OTHER||Ratio of GMC|0.86|||||TWO_SIDED|95.0|0.46|1.61|||t-test, 2 sided|||Serotype 19A, Day 30||1.61|0.46|
72520738|NCT03803202|144570638|OTHER||Ratio of GMC|0.87|||||TWO_SIDED|95.0|0.47|1.6|||t-test, 2 sided|||Serotype 19A, Day 30||1.60|0.47|
72520739|NCT03803202|144570638|OTHER||Ratio of GMC|1.0|||||TWO_SIDED|95.0|0.49|2.01|||t-test, 2 sided|||Serotype 19F, Day 30||2.01|0.49|
72520740|NCT03803202|144570638|OTHER||Ratio of GMC|1.38|||||TWO_SIDED|95.0|0.75|2.53|||t-test, 2 sided|||Serotype 19F, Day 30||2.53|0.75|
72520741|NCT03803202|144570638|OTHER||Ratio of GMC|1.41|||||TWO_SIDED|95.0|0.68|2.96|||t-test, 2 sided|||Serotype 19F, Day 30||2.96|0.68|
72520742|NCT03803202|144570638|OTHER||Ratio of GMC|0.46|||||TWO_SIDED|95.0|0.2|1.07|||t-test, 2 sided|||Serotype 23F, Day 30||1.07|0.20|
72520743|NCT03803202|144570638|OTHER||Ratio of GMC|0.5|||||TWO_SIDED|95.0|0.22|1.11|||t-test, 2 sided|||Serotype 23F, Day 30||1.11|0.22|
72520744|NCT03803202|144570638|OTHER||Ratio of GMC|0.64|||||TWO_SIDED|95.0|0.29|1.44|||t-test, 2 sided|||Serotype 23F, Day 30||1.44|0.29|
72520745|NCT03803202|144570642|OTHER||Ratio of GMT|0.8|||||TWO_SIDED|95.0|0.56|1.14|||t-test, 2 sided|||Serotype 1, Day 1||1.14|0.56|
72520746|NCT03803202|144570642|OTHER||Ratio of GMT|1.39|||||TWO_SIDED|95.0|0.89|2.16|||t-test, 2 sided|||Serotype 1, Day 1||2.16|0.89|
72520747|NCT03803202|144570642|OTHER||Ratio of GMT|0.73|||||TWO_SIDED|95.0|0.51|1.06|||t-test, 2 sided|||Serotype 1, Day 1||1.06|0.51|
72520748|NCT03803202|144570642|OTHER||Ratio of GMT|1.33|||||TWO_SIDED|95.0|0.85|2.09|||t-test, 2 sided|||Serotype 3, Day 1||2.09|0.85|
72520749|NCT03803202|144570642|OTHER||Ratio of GMT|1.45|||||TWO_SIDED|95.0|0.91|2.3|||t-test, 2 sided|||Serotype 3, Day 1||2.30|0.91|
72520750|NCT03803202|144570642|OTHER||Ratio of GMT|0.95|||||TWO_SIDED|95.0|0.6|1.49|||t-test, 2 sided|||Serotype 3, Day 1||1.49|0.60|
72405845|NCT01120210|144320153|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.95||||0.3748|TWO_SIDED|95.0|-1.204|3.102||two-sided p-value and two-sided alpha=0.05|ANCOVA|||95% confidence intervals and p values represent the placebo-subtracted LS mean change from baseline in FS at the end of the 30 ng/kg/min dose.||3.102|-1.204|0.3748
72405846|NCT01120210|144320154|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.08||||0.2123|TWO_SIDED|95.0|-4.198|18.359||two-sided p-value and two-sided alpha=0.05|ANCOVA|||95% confidence intervals and p values represent the placebo-subtracted LS mean change from baseline in SV at the end of the 5 ng/kg/min dose.||18.359|-4.198|0.2123
72405847|NCT01120210|144320154|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.78||||0.1083|TWO_SIDED|95.0|-2.016|19.575||two-sided p-value and two-sided alpha=0.05|ANCOVA|||95% confidence intervals and p values represent the placebo-subtracted LS mean change from baseline in SV at the end of the 15 ng/kg/min dose.||19.575|-2.016|0.1083
72520751|NCT03803202|144570642|OTHER||Ratio of GMT|0.81|||||TWO_SIDED|95.0|0.46|1.4|||t-test, 2 sided|||Serotype 4, Day 1||1.40|0.46|
72405848|NCT01120210|144320154|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.16||||0.018|TWO_SIDED|95.0|2.557|25.771||two-sided p-value and two-sided alpha=0.05|ANCOVA|||95% confidence intervals and p values represent the placebo-subtracted LS mean change from baseline in SV at the end of the 30 ng/kg/min dose.||25.771|2.557|0.0180
72520752|NCT03803202|144570642|OTHER||Ratio of GMT|1.09|||||TWO_SIDED|95.0|0.62|1.91|||t-test, 2 sided|||Serotype 4, Day 1||1.91|0.62|
72520753|NCT03803202|144570642|OTHER||Ratio of GMT|0.7|||||TWO_SIDED|95.0|0.4|1.23|||t-test, 2 sided|||Serotype 4, Day 1||1.23|0.40|
72520754|NCT03803202|144570642|OTHER||Ratio of GMT|0.98|||||TWO_SIDED|95.0|0.58|1.68|||t-test, 2 sided|||Serotype 5, Day 1||1.68|0.58|
72520755|NCT03803202|144570642|OTHER||Ratio of GMT|1.32|||||TWO_SIDED|95.0|0.76|2.29|||t-test, 2 sided|||Serotype 5, Day 1||2.29|0.76|
72520756|NCT03803202|144570642|OTHER||Ratio of GMT|0.88|||||TWO_SIDED|95.0|0.51|1.53|||t-test, 2 sided|||Serotype 5, Day 1||1.53|0.51|
72520757|NCT03803202|144570642|OTHER||Ratio of GMT|0.96|||||TWO_SIDED|95.0|0.54|1.72|||t-test, 2 sided|||Serotype 6A, Day 1||1.72|0.54|
72405849|NCT01120210|144320155|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.38||||0.4841|TWO_SIDED|95.0|-5.308|2.554||two-sided p-value and two-sided alpha=0.05|ANCOVA|||95% confidence intervals and p values represent the placebo-subtracted LS mean change from baseline in PASP at the end of the 5 ng/kg/min dose.||2.554|-5.308|0.4841
72405850|NCT01120210|144320155|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.99||||0.6665|TWO_SIDED|95.0|-5.567|3.594||two-sided p-value and two-sided alpha=0.05|ANCOVA|||95% confidence intervals and p values represent the placebo-subtracted LS mean change from baseline in SV at the end of the 15 ng/kg/min dose.||3.594|-5.567|0.6665
72405851|NCT01120210|144320155|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.02||||0.6904|TWO_SIDED|95.0|-4.107|6.148||two-sided p-value and two-sided alpha=0.05|ANCOVA|||95% confidence intervals and p values represent the placebo-subtracted LS mean change from baseline in PASP at the end of the 30 ng/kg/min dose.||6.148|-4.107|0.6904
72405852|NCT01120210|144320156|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.7||||0.6304|TWO_SIDED|95.0|-2.197|3.588||two-sided p-value and two-sided alpha=0.05|ANCOVA|||95% confidence intervals and p values represent the placebo-subtracted LS mean change from baseline in PADP at the end of the 5 ng/kg/min dose.||3.588|-2.197|0.6304
72405853|NCT01120210|144320156|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.35||||0.842|TWO_SIDED|95.0|-3.851|3.153||two-sided p-value and two-sided alpha=0.05|ANCOVA|||95% confidence intervals and p values represent the placebo-subtracted LS mean change from baseline in PADP at the end of the 15 ng/kg/min dose.||3.153|-3.851|0.8420
72405854|NCT01120210|144320156|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.73||||0.6658|TWO_SIDED|95.0|-4.138|2.669||two-sided p-value and two-sided alpha=0.05|ANCOVA|||95% confidence intervals and p values represent the placebo-subtracted LS mean change from baseline in PADP at the end of the 30 ng/kg/min dose.||2.669|-4.138|0.6658
72405855|NCT01120210|144320157|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-264.36||||0.051|TWO_SIDED|95.0|-529.875|1.147||two-sided p-value and two-sided alpha=0.05|ANCOVA|||95% confidence intervals and p values represent the placebo-subtracted LS mean change from baseline in SVR at the end of the 5 ng/kg/min dose.||1.147|-529.875|0.0510
72405856|NCT01120210|144320157|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-383.32||||0.0006|TWO_SIDED|95.0|-592.781|-173.867||two-sided p-value and two-sided alpha=0.05|ANCOVA|||95% confidence intervals and p values represent the placebo-subtracted LS mean change from baseline in SVR at the end of the 15 ng/kg/min dose.||-173.867|-592.781|0.0006
72520758|NCT03803202|144570642|OTHER||Ratio of GMT|1.1|||||TWO_SIDED|95.0|0.57|2.14|||t-test, 2 sided|||Serotype 6B, Day 1||2.14|0.57|
72520759|NCT03803202|144570642|OTHER||Ratio of GMT|1.63|||||TWO_SIDED|95.0|0.86|3.1|||t-test, 2 sided|||Serotype 6A, Day 1||3.10|0.86|
72520760|NCT03803202|144570642|OTHER||Ratio of GMT|1.61|||||TWO_SIDED|95.0|0.83|3.14|||t-test, 2 sided|||Serotype 6A, Day 1||3.14|0.83|
72520761|NCT03803202|144570642|OTHER||Ratio of GMT|1.15|||||TWO_SIDED|95.0|0.59|2.24|||t-test, 2 sided|||Serotype 6B, Day 1||2.24|0.59|
72520762|NCT03803202|144570642|OTHER||Ratio of GMT|1.18|||||TWO_SIDED|95.0|0.58|2.39|||t-test, 2 sided|||Serotype 6B, Day 1||2.39|0.58|
72520763|NCT03803202|144570642|OTHER||Ratio of GMT|0.84|||||TWO_SIDED|95.0|0.4|1.8|||t-test, 2 sided|||Serotype 7F, Day 1||1.80|0.40|
72520764|NCT03803202|144570642|OTHER||Ratio of GMT|1.35|||||TWO_SIDED|95.0|0.63|2.87|||t-test, 2 sided|||Serotype 7F, Day 1||2.87|0.63|
72520765|NCT03803202|144570642|OTHER||Ratio of GMT|1.03|||||TWO_SIDED|95.0|0.45|2.37|||t-test, 2 sided|||Serotype 7F, Day 1||2.37|0.45|
72520766|NCT03803202|144570642|OTHER||Ratio of GMT|0.65||||||95.0|0.32|1.32|||t-test, 2 sided|||Serotype 9V, Day 1||1.32|0.32|
72520767|NCT03803202|144570642|OTHER||Ratio of GMT|0.78|||||TWO_SIDED|95.0|0.37|1.64|||t-test, 2 sided|||Serotype 9V, Day 1||1.64|0.37|
72520768|NCT03803202|144570642|OTHER||Ratio of GMT|0.66|||||TWO_SIDED|95.0|0.3|1.49|||t-test, 2 sided|||Serotype 9V, Day 1||1.49|0.30|
72520769|NCT03803202|144570642|OTHER||Ratio of GMT|0.61|||||TWO_SIDED|95.0|0.31|1.18|||t-test, 1 sided|||Serotype 14, Day 1||1.18|0.31|
72520770|NCT03803202|144570642|OTHER||Ratio of GMT|1.09|||||TWO_SIDED|95.0|0.54|2.18|||t-test, 2 sided|||Serotype 14, Day 1||2.18|0.54|
72520771|NCT03803202|144570642|OTHER||Ratio of GMT|1.32|||||TWO_SIDED|95.0|0.66|2.65|||t-test, 2 sided|||Serotype 14, Day 1||2.65|0.66|
72520772|NCT03803202|144570642|OTHER||Ratio of GMT|0.54|||||TWO_SIDED|95.0|0.3|0.95|||t-test, 2 sided|||Serotype 18C, Day 1||0.95|0.30|
72520773|NCT03803202|144570642|OTHER||Ratio of GMT|1.37|||||TWO_SIDED|95.0|0.73|2.57|||t-test, 2 sided|||Serotype 18C, Day 1||2.57|0.73|
72520774|NCT03803202|144570642|OTHER||Ratio of GMT|0.58|||||TWO_SIDED|95.0|0.32|1.04|||t-test, 2 sided|||Serotype 18C, Day 1||1.04|0.32|
72520775|NCT03803202|144570642|OTHER||Ratio of GMT|0.76|||||TWO_SIDED|95.0|0.44|1.32|||t-test, 2 sided|||Serotype 19A, Day 1||1.32|0.44|
72520776|NCT03803202|144570642|OTHER||Ratio of GMT|1.15|||||TWO_SIDED|95.0|0.66|2.01|||t-test, 2 sided|||Serotype 19A, Day 1||2.01|0.66|
72520777|NCT03803202|144570642|OTHER||Ratio of GMT|0.84|||||TWO_SIDED|95.0|0.48|1.5|||t-test, 2 sided|||Serotype 19A, Day 1||1.50|0.48|
72520778|NCT03803202|144570642|OTHER||Ratio of GMT|0.79|||||TWO_SIDED|95.0|0.45|1.38|||t-test, 2 sided|||Serotype 19F, Day 1||1.38|0.45|
72520779|NCT03803202|144570642|OTHER||Ratio of GMT|0.84|||||TWO_SIDED|95.0|0.47|1.52|||t-test, 2 sided|||Serotype 19F, Day 1||1.52|0.47|
72520780|NCT03803202|144570642|OTHER||Ratio of GMT|0.62|||||TWO_SIDED|95.0|0.34|1.12|||t-test, 2 sided|||Serotype 19F, Day 1||1.12|0.34|
72520781|NCT03803202|144570642|OTHER||Ratio of GMT|1.11|||||TWO_SIDED|95.0|0.64|1.94|||t-test, 2 sided|||Serotype 23F, Day 1||1.94|0.64|
72520782|NCT03803202|144570642|OTHER||Ratio of GMT|1.37|||||TWO_SIDED|95.0|0.77|2.42|||t-test, 2 sided|||Serotype 23F, Day 1||2.42|0.77|
72520783|NCT03803202|144570642|OTHER||Ratio of GMT|1.19|||||TWO_SIDED|95.0|0.66|2.14|||t-test, 2 sided|||Serotype 23F, Day 1||2.14|0.66|
72520784|NCT03803202|144570642|OTHER||Ratio of GMT|0.83|||||TWO_SIDED|95.0|0.47|1.47|||t-test, 2 sided|||Serotype 1, Day 30||1.47|0.47|
72520785|NCT03803202|144570642|OTHER||Ratio of GMT|0.87|||||TWO_SIDED|95.0|0.5|1.53|||t-test, 2 sided|||Serotype 1, Day 30||1.53|0.50|
72520786|NCT03803202|144570642|OTHER||Ratio of GMT|1.28|||||TWO_SIDED|95.0|0.74|2.2|||t-test, 2 sided|||Serotype 1, Day 30||2.20|0.74|
72569835|NCT02944383|144670014|SUPERIORITY|||||||0.3998||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.3998
72405857|NCT01120210|144320157|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-527.77||||0.0001|TWO_SIDED|95.0|-764.07|-291.478||two-sided p-value and two-sided alpha=0.05|ANCOVA|||95% confidence intervals and p values represent the placebo-subtracted LS mean change from baseline in SVR at the end of the 30 ng/kg/min dose.||-291.478|-764.070|0.0001
72520787|NCT03803202|144570642|OTHER||Ratio of GMT|25.03|||||TWO_SIDED|95.0|16.33|38.34|||t-test, 2 sided|||Serotype 2, Day 30||38.34|16.33|
72520788|NCT03803202|144570642|OTHER||Ratio of GMT|21.99|||||TWO_SIDED|95.0|14.31|33.77|||t-test, 2 sided|||Serotype 2, Day 30||33.77|14.31|
72569836|NCT02944383|144670014|SUPERIORITY|||||||0.3659||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.3659
72520789|NCT03803202|144570642|OTHER||Ratio of GMT|35.38|||||TWO_SIDED|95.0|23.09|54.22|||t-test, 2 sided|||Serotype 2, Day 30||54.22|23.09|
72520790|NCT03803202|144570642|OTHER||Ratio of GMT|1.81|||||TWO_SIDED|95.0|1.25|2.62|||t-test, 2 sided|||Serotype 3, Day 30||2.62|1.25|
72520791|NCT03803202|144570642|OTHER||Ratio of GMT|2.55|||||TWO_SIDED|95.0|1.83|3.56|||t-test, 2 sided|||Serotype 3, Day 30||3.56|1.83|
72520792|NCT03803202|144570642|OTHER||Ratio of GMT|3.14|||||TWO_SIDED|95.0|2.2|4.48|||t-test, 2 sided|||Serotype 3, Day 30||4.48|2.20|
72520793|NCT03803202|144570642|OTHER||Ratio of GMT|0.98|||||TWO_SIDED|95.0|0.59|1.62|||t-test, 2 sided|||Serotype 4, Day 30||1.62|0.59|
72520794|NCT03803202|144570642|OTHER||Ratio of GMT|0.94|||||TWO_SIDED|95.0|0.59|1.51|||t-test, 2 sided|||Serotype 4, Day 30||1.51|0.59|
72520795|NCT03803202|144570642|OTHER||Ratio of GMT|1.23|||||TWO_SIDED|95.0|0.76|1.99|||t-test, 2 sided|||Serotype 4, Day 30||1.99|0.76|
72520796|NCT03803202|144570642|OTHER||Ratio of GMT|1.25|||||TWO_SIDED|95.0|0.71|2.21|||t-test, 2 sided|||Serotype 5, Day 30||2.21|0.71|
72520797|NCT03803202|144570642|OTHER||Ratio of GMT|1.45|||||TWO_SIDED|95.0|0.85|2.46|||t-test, 2 sided|||Serotype 5, Day 30||2.46|0.85|
72520798|NCT03803202|144570642|OTHER||Ratio of GMT|2.15|||||TWO_SIDED|95.0|1.25|3.72|||t-test, 2 sided|||Serotype 5, Day 30||3.72|1.25|
72520799|NCT03803202|144570642|OTHER||Ratio of GMT|0.94|||||TWO_SIDED|95.0|0.59|1.51|||t-test, 2 sided|||Serotype 6B, Day 30||1.51|0.59|
72520800|NCT03803202|144570642|OTHER||Ratio of GMT|0.85|||||TWO_SIDED|95.0|0.56|1.29|||t-test, 2 sided|||Serotype 6B, Day 30||1.29|0.56|
72520801|NCT03803202|144570642|OTHER||Ratio of GMT|0.84|||||TWO_SIDED|95.0|0.54|1.3|||t-test, 2 sided|||Serotype 6B, Day 30||1.30|0.54|
72520802|NCT03803202|144570642|OTHER||Ratio of GMT|0.85|||||TWO_SIDED|95.0|0.61|1.18|||t-test, 2 sided|||Serotype 7F, Day 30||1.18|0.61|
72520803|NCT03803202|144570642|OTHER||Ratio of GMT|0.89|||||TWO_SIDED|95.0|0.65|1.21|||t-test, 2 sided|||Serotype 7F, Day 30||1.21|0.65|
72520804|NCT03803202|144570642|OTHER||Ratio of GMT|1.05|||||TWO_SIDED|95.0|0.73|1.5|||t-test, 2 sided|||Serotype 7F, Day 30||1.50|0.73|
72520805|NCT03803202|144570642|OTHER||Ratio of GMT|19.46|||||TWO_SIDED|95.0|12.26|30.87|||t-test, 2 sided|||Serotype 8, Day 30||30.87|12.26|
72520806|NCT03803202|144570642|OTHER||Ratio of GMT|19.65|||||TWO_SIDED|95.0|12.07|32.0|||t-test, 2 sided|||Serotype 8, Day 30||32.00|12.07|
72520807|NCT03803202|144570642|OTHER||Ratio of GMT|41.87|||||TWO_SIDED|95.0|26.2|66.9|||t-test, 2 sided|||Serotype 8, Day 30||66.90|26.20|
72520808|NCT03803202|144570642|OTHER||Ratio of GMT|4.75|||||TWO_SIDED|95.0|3.06|7.36|||t-test, 2 sided|||Serotype 9N, Day 30||7.36|3.06|
72520809|NCT03803202|144570642|OTHER||Ratio of GMT|5.66|||||TWO_SIDED|95.0|3.83|8.37|||t-test, 2 sided|||Serotype 9N, Day 30||8.37|3.83|
72520810|NCT03803202|144570642|OTHER||Ratio of GMT|7.84|||||TWO_SIDED|95.0|5.19|11.82|||t-test, 2 sided|||Serotype 9N, Day 30||11.82|5.19|
72520811|NCT03803202|144570642|OTHER||Ratio of GMT|0.83|||||TWO_SIDED|95.0|0.49|1.42|||t-test, 2 sided|||Serotype 9V, Day 30||1.42|0.49|
72520812|NCT03803202|144570642|OTHER||Ratio of GMT|0.71|||||TWO_SIDED|95.0|0.44|1.14|||t-test, 2 sided|||Serotype 9V, Day 30||1.14|0.44|
72520813|NCT03803202|144570642|OTHER||Ratio of GMT|1.21|||||TWO_SIDED|95.0|0.76|1.95|||t-test, 2 sided|||Serotype 9V, Day 30||1.95|0.76|
72520814|NCT03803202|144570642|OTHER||Ratio of GMT|0.69|||||TWO_SIDED|95.0|0.39|1.21|||t-test, 2 sided|||Serotype 6A, Day 30||1.21|0.39|
72520815|NCT03803202|144570642|OTHER||Ratio of GMT|0.9|||||TWO_SIDED|95.0|0.54|1.5|||t-test, 2 sided|||Serotype 6A, Day 30||1.50|0.54|
72520816|NCT03803202|144570642|OTHER||Ratio of GMT|0.93|||||TWO_SIDED|95.0|0.53|1.64|||t-test, 2 sided|||Serotype 6A, Day 30||1.64|0.53|
72520817|NCT03803202|144570642|OTHER||Ratio of GMT|1.33|||||TWO_SIDED|95.0|0.84|2.11|||t-test, 2 sided|||Serotype 14, Day 30||2.11|0.84|
72520818|NCT03803202|144570642|OTHER||Ratio of GMT|0.89|||||TWO_SIDED|95.0|0.55|1.43|||t-test, 2 sided|||Serotype 14, Day 30||1.43|0.55|
72520819|NCT03803202|144570642|OTHER||Ratio of GMT|1.54|||||TWO_SIDED|95.0|0.95|2.5|||t-test, 2 sided|||Serotype 14, Day 30||2.50|0.95|
72520820|NCT03803202|144570642|OTHER||Ratio of GMT|0.89|||||TWO_SIDED|95.0|0.55|1.44|||t-test, 2 sided|||Serotype 18C, Day 30||1.44|0.55|
72520821|NCT03803202|144570642|OTHER||Ratio of GMT|0.98|||||TWO_SIDED|95.0|0.63|1.54|||t-test, 2 sided|||Serotype 18C, Day 30||1.54|0.63|
72520822|NCT03803202|144570642|OTHER||Ratio of GMT|1.32|||||TWO_SIDED|95.0|0.82|2.12|||t-test, 2 sided|||Serotype 18C, Day 30||2.12|0.82|
72520823|NCT03803202|144570642|OTHER||Ratio of GMT|0.98|||||TWO_SIDED|95.0|0.7|1.37|||t-test, 2 sided|||Serotype 19A, Day 30||1.37|0.70|
72520824|NCT03803202|144570642|OTHER||Ratio of GMT|0.98|||||TWO_SIDED|95.0|0.71|1.37|||t-test, 2 sided|||Serotype 19A, Day 30||1.37|0.71|
72520825|NCT03803202|144570642|OTHER||Ratio of GMT|1.14|||||TWO_SIDED|95.0|0.78|1.67|||t-test, 2 sided|||Serotype 19A, Day 30||1.67|0.78|
72520826|NCT03803202|144570642|OTHER||Ratio of GMT|1.52||||||95.0|0.99|2.32|||t-test, 2 sided|||Serotype 19F, Day 30||2.32|0.99|
72520827|NCT03803202|144570642|OTHER||Ratio of GMT|1.48|||||TWO_SIDED|95.0|1.0|2.18|||t-test, 2 sided|||Serotype 19F, Day 30||2.18|1.00|
72520828|NCT03803202|144570642|OTHER||Ratio of GMT|2.08|||||TWO_SIDED|95.0|1.35|3.22|||t-test, 2 sided|||Serotype 19F, Day 30||3.22|1.35|
72520829|NCT03803202|144570642|OTHER||Ratio of GMT|0.67|||||TWO_SIDED|95.0|0.36|1.26|||t-test, 2 sided|||Serotype 23F, Day 30||1.26|0.36|
72520830|NCT03803202|144570642|OTHER||Ratio of GMT|0.71|||||TWO_SIDED|95.0|0.4|1.26|||t-test, 2 sided|||Serotype 23F, Day 30||1.26|0.40|
72520831|NCT03803202|144570642|OTHER||Ratio of GMT|0.9|||||TWO_SIDED|95.0|0.47|1.73|||t-test, 2 sided|||Serotype 23F, Day 30||1.73|0.47|
72520832|NCT03803202|144570643|OTHER||Ratio of GMC|0.9|||||TWO_SIDED|95.0|0.57|1.42|||t-test, 2 sided|||Serotype 1, Day 1||1.42|0.57|
72520833|NCT03803202|144570643|OTHER||Ratio of GMC|1.85|||||TWO_SIDED|95.0|1.12|3.08|||t-test, 2 sided|||Serotype 1, Day 1||3.08|1.12|
72520834|NCT03803202|144570643|OTHER||Ratio of GMC|0.88|||||TWO_SIDED|95.0|0.53|1.49|||t-test, 2 sided|||Serotype 1, Day 1||1.49|0.53|
72520835|NCT03803202|144570643|OTHER||Ratio of GMC|1.25|||||TWO_SIDED|95.0|0.84|1.87|||t-test, 2 sided|||Serotype 3, Day 1||1.87|0.84|
72520836|NCT03803202|144570643|OTHER||Ratio of GMC|1.79|||||TWO_SIDED|95.0|1.18|2.73|||t-test, 2 sided|||Serotype 3, Day 1||2.73|1.18|
72520837|NCT03803202|144570643|OTHER||Ratio of GMC|1.08|||||TWO_SIDED|95.0|0.69|1.69|||t-test, 2 sided|||Serotype 3, Day 1||1.69|0.69|
72520838|NCT03803202|144570643|OTHER||Ratio of GMC|0.81|||||TWO_SIDED|95.0|0.54|1.21|||t-test, 2 sided|||Serotype 4, Day 1||1.21|0.54|
72520839|NCT03803202|144570643|OTHER||Ratio of GMC|1.16|||||TWO_SIDED|95.0|0.74|1.81|||t-test, 2 sided|||Serotype 4, Day 1||1.81|0.74|
72520840|NCT03803202|144570643|OTHER||Ratio of GMC|0.67|||||TWO_SIDED|95.0|0.44|1.0|||t-test, 2 sided|||Serotype 4, Day 1||1.00|0.44|
72520841|NCT03803202|144570643|OTHER||Ratio of GMC|1.08|||||TWO_SIDED|95.0|0.65|1.78|||t-test, 2 sided|||Serotype 5, Day 1||1.78|0.65|
72520842|NCT03803202|144570643|OTHER||Ratio of GMC|1.59|||||TWO_SIDED|95.0|0.96|2.63|||t-test, 2 sided|||Serotype 5, Day 1||2.63|0.96|
72520843|NCT03803202|144570643|OTHER||Ratio of GMC|1.0|||||TWO_SIDED|95.0|0.58|1.72|||t-test, 2 sided|||Serotype 5, Day 1||1.72|0.58|
72520844|NCT03803202|144570643|OTHER||Ratio of GMC|0.88|||||TWO_SIDED|95.0|0.53|1.47|||t-test, 2 sided|||Serotype 6A, Day 1||1.47|0.53|
72520845|NCT03803202|144570643|OTHER||Ratio of GMC|1.39|||||TWO_SIDED|95.0|0.83|2.3|||t-test, 2 sided|||Serotype 6A, Day 1||2.30|0.83|
72520846|NCT03803202|144570643|OTHER||Ratio of GMC|1.4|||||TWO_SIDED|95.0|0.8|2.44|||t-test, 2 sided|||Serotype 6A, Day 1||2.44|0.80|
72520847|NCT03803202|144570643|OTHER||Ratio of GMC|1.17|||||TWO_SIDED|95.0|0.69|1.99|||t-test, 2 sided|||Serotype 6B, Day 1||1.99|0.69|
72520848|NCT03803202|144570643|OTHER||Ratio of GMC|2.09|||||TWO_SIDED|95.0|1.19|3.67|||t-test, 2 sided|||Serotype 6B, Day 1||3.67|1.19|
72520849|NCT03803202|144570643|OTHER||Ratio of GMC|1.59|||||TWO_SIDED|95.0|0.88|2.88|||t-test, 2 sided|||Serotype 6B, Day 1||2.88|0.88|
72520850|NCT03803202|144570643|OTHER||Ratio of GMC|1.01|||||TWO_SIDED|95.0|0.62|1.65|||t-test, 2 sided|||Serotype 7F, Day 1||1.65|0.62|
72520851|NCT03803202|144570643|OTHER||Ratio of GMC|1.58|||||TWO_SIDED|95.0|0.94|2.67|||t-test, 2 sided|||Serotype 7F, Day 1||2.67|0.94|
72520852|NCT03803202|144570643|OTHER||Ratio of GMC|0.9|||||TWO_SIDED|95.0|0.5|1.64|||t-test, 2 sided|||Serotype 7F, Day 1||1.64|0.50|
72520853|NCT03803202|144570643|OTHER||Ratio of GMC|0.79|||||TWO_SIDED|95.0|0.52|1.21|||t-test, 2 sided|||Serotype 9V, Day 1||1.21|0.52|
72520854|NCT03803202|144570643|OTHER||Ratio of GMC|1.57|||||TWO_SIDED|95.0|0.97|2.54|||t-test, 2 sided|||Serotype 9V, Day 1||2.54|0.97|
72520855|NCT03803202|144570643|OTHER||Ratio of GMC|0.99|||||TWO_SIDED|95.0|0.6|1.6|||t-test, 2 sided|||Serotype 9V, Day 1||1.60|0.60|
72520856|NCT03803202|144570643|OTHER||Ratio of GMC|0.73|||||TWO_SIDED|95.0|0.4|1.33|||t-test, 2 sided|||Serotype 14, Day 1||1.33|0.40|
72520857|NCT03803202|144570643|OTHER||Ratio of GMC|1.33|||||TWO_SIDED|95.0|0.73|2.44|||t-test, 2 sided|||Serotype 14, Day 1||2.44|0.73|
72520858|NCT03803202|144570643|OTHER||Ratio of GMC|0.87|||||TWO_SIDED|95.0|0.46|1.63|||t-test, 2 sided|||Serotype 14, Day 1||1.63|0.46|
72520859|NCT03803202|144570643|OTHER||Ratio of GMC|0.69|||||TWO_SIDED|95.0|0.42|1.12|||t-test, 2 sided|||Serotype 18C, Day 1||1.12|0.42|
72520860|NCT03803202|144570643|OTHER||Ratio of GMC|1.53|||||TWO_SIDED|95.0|0.92|2.55|||t-test, 2 sided|||Serotype 18C, Day 1||2.55|0.92|
72520861|NCT03803202|144570643|OTHER||Ratio of GMC|0.78|||||TWO_SIDED|95.0|0.44|1.37|||t-test, 2 sided|||Serotype 18C, Day 1||1.37|0.44|
72520862|NCT03803202|144570643|OTHER||Ratio of GMC|0.82|||||TWO_SIDED|95.0|0.54|1.25|||t-test, 2 sided|||Serotype 19A, Day 1||1.25|0.54|
72520863|NCT03803202|144570643|OTHER||Ratio of GMC|1.34|||||TWO_SIDED|95.0|0.84|2.12|||t-test, 2 sided|||Serotype 19A, Day 1||2.12|0.84|
72520864|NCT03803202|144570643|OTHER||Ratio of GMC|1.05|||||TWO_SIDED|95.0|0.66|1.66|||t-test, 2 sided|||Serotype 19A, Day 1||1.66|0.66|
72520865|NCT03803202|144570643|OTHER||Ratio of GMC|0.83|||||TWO_SIDED|95.0|0.51|1.37|||t-test, 2 sided|||Serotype 19F, Day 1||1.37|0.51|
72520866|NCT03803202|144570643|OTHER||Ratio of GMC|1.26|||||TWO_SIDED|95.0|0.75|2.11|||t-test, 2 sided|||Serotype 19F, Day 1||2.11|0.75|
72520867|NCT03803202|144570643|OTHER||Ratio of GMC|0.99|||||TWO_SIDED|95.0|0.57|1.72|||t-test, 2 sided|||Serotype 19F, Day 1||1.72|0.57|
72520868|NCT03803202|144570643|OTHER||Ratio of GMC|1.08|||||TWO_SIDED|95.0|0.63|1.86|||t-test, 2 sided|||Serotype 23F, Day 1||1.86|0.63|
72520869|NCT03803202|144570643|OTHER||Ratio of GMC|1.19|||||TWO_SIDED|95.0|0.69|2.08|||t-test, 2 sided|||Serotype 23F, Day 1||2.08|0.69|
72520870|NCT03803202|144570643|OTHER||Ratio of GMC|1.19|||||TWO_SIDED|95.0|0.67|2.14|||t-test, 2 sided|||Serotype 23F, Day 1||2.14|0.67|
72520871|NCT03803202|144570643|OTHER||Ratio of GMC|0.82|||||TWO_SIDED|95.0|0.52|1.29|||t-test, 2 sided|||Serotype 1, Day 30||1.29|0.52|
72520872|NCT03803202|144570643|OTHER||Ratio of GMC|1.04|||||TWO_SIDED|95.0|0.68|1.59|||t-test, 2 sided|||Serotype 1, Day 30||1.59|0.68|
72520873|NCT03803202|144570643|OTHER||Ratio of GMC|1.17|||||TWO_SIDED|95.0|0.76|1.8|||t-test, 2 sided|||Serotype 1, Day 30||1.80|0.76|
72520874|NCT03803202|144570643|OTHER||Ratio of GMC|2.07|||||TWO_SIDED|95.0|1.42|3.01|||t-test, 2 sided|||Serotype 3, Day 30||3.01|1.42|
72520875|NCT03803202|144570643|OTHER||Ratio of GMC|3.29|||||TWO_SIDED|95.0|2.37|4.58|||t-test, 2 sided|||Serotype 3, Day 30||4.58|2.37|
72520876|NCT03803202|144570643|OTHER||Ratio of GMC|4.05|||||TWO_SIDED|95.0|2.83|5.79|||t-test, 2 sided|||Serotype 3, Day 30||5.79|2.83|
72520877|NCT03803202|144570643|OTHER||Ratio of GMC|0.79|||||TWO_SIDED|95.0|0.49|1.27|||t-test, 2 sided|||Serotype 4, Day 30||1.27|0.49|
72520878|NCT03803202|144570643|OTHER||Ratio of GMC|0.97|||||TWO_SIDED|95.0|0.63|1.48|||t-test, 2 sided|||Serotype 4, Day 30||1.48|0.63|
72520879|NCT03803202|144570643|OTHER||Ratio of GMC|1.05|||||TWO_SIDED|95.0|0.66|1.65|||t-test, 2 sided|||Serotype 4, Day 30||1.65|0.66|
72520880|NCT03803202|144570643|OTHER||Ratio of GMC|1.31|||||TWO_SIDED|95.0|0.75|2.29|||t-test, 2 sided|||Serotype 5, Day 30||2.29|0.75|
72520881|NCT03803202|144570643|OTHER||Ratio of GMC|1.3|||||TWO_SIDED|95.0|0.77|2.19|||t-test, 2 sided|||Serotype 5, Day 30||2.19|0.77|
72520882|NCT03803202|144570643|OTHER||Ratio of GMC|1.91|||||TWO_SIDED|95.0|1.08|3.37|||t-test, 2 sided|||Serotype 5, Day 30||3.37|1.08|
72520883|NCT03803202|144570643|OTHER||Ratio of GMC|0.86|||||TWO_SIDED|95.0|0.5|1.49|||t-test, 2 sided|||Serotype 6A, Day 30||1.49|0.50|
72520884|NCT03803202|144570643|OTHER||Ratio of GMC|1.06|||||TWO_SIDED|95.0|0.65|1.72|||t-test, 2 sided|||Serotype 6A, Day 30||1.72|0.65|
72520885|NCT03803202|144570643|OTHER||Ratio of GMC|1.22|||||TWO_SIDED|95.0|0.71|2.1|||t-test, 2 sided|||Serotype 6A, Day 30||2.10|0.71|
72520886|NCT03803202|144570643|OTHER||Ratio of GMC|0.99|||||TWO_SIDED|95.0|0.56|1.75|||t-test, 2 sided|||Serotype 6B, Day 30||1.75|0.56|
72520887|NCT03803202|144570643|OTHER||Ratio of GMC|1.44|||||TWO_SIDED|95.0|0.84|2.47|||t-test, 2 sided|||Serotype 6B, Day 30||2.47|0.84|
72520888|NCT03803202|144570643|OTHER||Ratio of GMC|1.77|||||TWO_SIDED|95.0|1.0|3.15|||t-test, 2 sided|||Serotype 6B, Day 30||3.15|1.00|
72520889|NCT03803202|144570643|OTHER||Ratio of GMC|1.54|||||TWO_SIDED|95.0|1.02|2.3|||t-test, 2 sided|||Serotype 7F, Day 30||2.30|1.02|
72520890|NCT03803202|144570643|OTHER||Ratio of GMC|1.55|||||TWO_SIDED|95.0|1.06|2.26|||t-test, 2 sided|||Serotype 7F, Day 30||2.26|1.06|
72520891|NCT03803202|144570643|OTHER||Ratio of GMC|1.66|||||TWO_SIDED|95.0|1.09|2.53|||t-test, 2 sided|||Serotype 7F, Day 30||2.53|1.09|
72520892|NCT03803202|144570643|OTHER||Ratio of GMC|1.29|||||TWO_SIDED|95.0|0.81|2.07|||t-test, 2 sided|||Serotype 9V, Day 30||2.07|0.81|
72520893|NCT03803202|144570643|OTHER||Ratio of GMC|1.64|||||TWO_SIDED|95.0|1.04|2.57|||t-test, 2 sided|||Serotype 9V, Day 30||2.57|1.04|
72569837|NCT02944383|144670014|SUPERIORITY|||||||0.3998||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||EOS (average of week 10 and 12)||||0.3998
72569838|NCT02944383|144670014|SUPERIORITY|||||||0.3659||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||EOS (average of week 10 and 12)||||0.3659
72569839|NCT02944383|144670015|SUPERIORITY|||||||0.8823||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.8823
72520894|NCT03803202|144570643|OTHER||Ratio of GMC|2.16|||||TWO_SIDED|95.0|1.35|3.47|||t-test, 2 sided|||Serotype 9V, Day 30||3.47|1.35|
72520895|NCT03803202|144570643|OTHER||Ratio of GMC|0.99|||||TWO_SIDED|95.0|0.58|1.68|||t-test, 2 sided|||Serotype 14, Day 30||1.68|0.58|
72520896|NCT03803202|144570643|OTHER||Ratio of GMC|1.26|||||TWO_SIDED|95.0|0.77|2.05|||t-test, 2 sided|||Serotype 14, Day 30||2.05|0.77|
72520897|NCT03803202|144570643|OTHER||Ratio of GMC|1.67|||||TWO_SIDED|95.0|0.99|2.81|||t-test, 2 sided|||Serotype 14, Day 30||2.81|0.99|
72520898|NCT03803202|144570643|OTHER||Ratio of GMC|0.61|||||TWO_SIDED|95.0|0.39|0.95|||t-test, 2 sided|||Serotype 18C, Day 30||0.95|0.39|
72520899|NCT03803202|144570643|OTHER||Ratio of GMC|1.04|||||TWO_SIDED|95.0|0.7|1.54|||t-test, 2 sided|||Serotype 18C, Day 30||1.54|0.70|
72520900|NCT03803202|144570643|OTHER||Ratio of GMC|1.03|||||TWO_SIDED|95.0|0.67|1.57|||t-test, 2 sided|||Serotype 18C, Day 30||1.57|0.67|
72520901|NCT03803202|144570643|OTHER||Ratio of GMC|0.83|||||TWO_SIDED|95.0|0.56|1.25|||t-test, 2 sided|||Serotype 19A, Day 30||1.25|0.56|
72520902|NCT03803202|144570643|OTHER||Ratio of GMC|1.07|||||TWO_SIDED|95.0|0.75|1.52|||t-test, 2 sided|||Serotype 19A, Day 30||1.52|0.75|
72520903|NCT03803202|144570643|OTHER||Ratio of GMC|1.2|||||TWO_SIDED|95.0|0.77|1.86|||t-test, 2 sided|||Serotype 19A, Day 30||1.86|0.77|
72520904|NCT03803202|144570643|OTHER||Ratio of GMC|1.2|||||TWO_SIDED|95.0|0.76|1.9|||t-test, 2 sided|||Serotype 19F, Day 30||1.90|0.76|
72520905|NCT03803202|144570643|OTHER||Ratio of GMC|1.69|||||TWO_SIDED|95.0|1.11|2.58|||t-test, 2 sided|||Serotype 19F, Day 30||2.58|1.11|
72520906|NCT03803202|144570643|OTHER||Ratio of GMC|2.23|||||TWO_SIDED|95.0|1.41|3.52|||t-test, 2 sided|||Serotype 19F, Day 30||3.52|1.41|
72520907|NCT03803202|144570643|OTHER||Ratio of GMC|0.86|||||TWO_SIDED|95.0|0.5|1.47|||t-test, 2 sided|||Serotype 23F, Day 30||1.47|0.50|
72520908|NCT03803202|144570643|OTHER||Ratio of GMC|0.83|||||TWO_SIDED|95.0|0.51|1.35|||t-test, 2 sided|||Serotype 23F, Day 30||1.35|0.51|
72520909|NCT03803202|144570643|OTHER||Ratio of GMC|1.18|||||TWO_SIDED|95.0|0.69|2.02|||t-test, 2 sided|||Serotype 23F, Day 30||2.02|0.69|
72520910|NCT03803202|144570646|OTHER||Mean Difference|0.1||||0.805|TWO_SIDED|95.0|-0.4|0.5|||ANCOVA|||Serotype 1, Day 30||0.5|-0.4|0.805
72520911|NCT03803202|144570646|OTHER||Mean Difference|0.4||||0.102|TWO_SIDED|95.0|-0.1|0.9|||ANCOVA|||Serotype 1, Day 30||0.9|-0.1|0.102
72405858|NCT05320029|144320162|NON_INFERIORITY|If the two-side 95%CI limit of the difference between the two groups is greater than the non-inferiority margin of -10%, the non-inferiority hypothesis of this study is valid|Mean Difference (Final Values)|0.0|||<|0.05|TWO_SIDED|95.0|-0.0458|0.0458|||Newcombe-Wilson|||||0.0458|-0.0458|<0.05
72405859|NCT00384813|144320203|SUPERIORITY_OR_OTHER||regression coefficient|0.33||||0.23||||||For both baseline to 4 month analyses (see above p value) and baseline to 10 month analyses, the variable of intervention group did not contribute significant additional variance.|Regression, Linear|||||||0.23
72405860|NCT04399161|144320209|SUPERIORITY|||||||0.123|||||||ANOVA|||Comparison among Children||||0.123
72405861|NCT04399161|144320209|SUPERIORITY|||||||0.314|||||||ANOVA|||Comparison among Elderly||||0.314
72520912|NCT03803202|144570646|OTHER||Mean Difference|0.4||||0.158|TWO_SIDED|95.0|-0.1|0.9|||ANCOVA|||Serotype 1, Day 30||0.9|-0.1|0.158
72520913|NCT03803202|144570646|OTHER||Mean Difference|-0.1||||0.596|TWO_SIDED|95.0|-0.4|0.2|||ANCOVA|||Serotype 2, Day 30||0.2|-0.4|0.596
72520914|NCT03803202|144570646|OTHER||Mean Difference|0.3||||0.025|TWO_SIDED|95.0|0.0|0.7|||ANCOVA|||Serotype 2, Day 30||0.7|0.0|0.025
72520915|NCT03803202|144570646|OTHER||Mean Difference|0.4||||0.005|TWO_SIDED|95.0|0.1|0.7|||ANCOVA|||Serotype 2, Day 30||0.7|0.1|0.005
72520916|NCT03803202|144570646|OTHER||Mean Difference|0.3||||0.037|TWO_SIDED|95.0|0.0|0.7|||ANCOVA|||Serotype 3, Day 30||0.7|0.0|0.037
72520917|NCT03803202|144570646|OTHER||Mean Difference|0.6||||0.002|TWO_SIDED|95.0|0.2|0.9|||ANCOVA|||Serotype 3, Day 30||0.9|0.2|0.002
72520918|NCT03803202|144570646|OTHER||Mean Difference|0.2||||0.23|TWO_SIDED|95.0|-0.1|0.6|||ANCOVA|||Serotype 3, Day 30||0.6|-0.1|0.230
72569840|NCT02944383|144670015|SUPERIORITY|||||||0.3788||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.3788
72569841|NCT02944383|144670015|SUPERIORITY|||||||0.1091||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.1091
72405862|NCT02800148|144320228|EQUIVALENCE|provides 85% power of success|equivalence ratio|107.0|||||TWO_SIDED|90.0|96.1|115.5||No p-value as calculated for bioequivalence, just a T/R ratio and 90% confidence interval|Fieller's method|||||115.5|96.1|
72405863|NCT01455012|144320229|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-160.34|STANDARD_ERROR_OF_MEAN|26.46|<|0.0001|TWO_SIDED|95.0|-213.23|-107.45||The analysis of this primary efficacy variable was performed using a two-sided alpha level of 5 %.|ANCOVA||The treatment effect was estimated on the basis of the Least Square Mean (LSM) of the difference as well as on the 95 % Confidence Interval and the p-value for that difference. Difference to Placebo was calculated as Rotigotine-Placebo.|The 95 % Confidence Interval (CI) and the p-value for the mean difference between Rotigotine and Placebo was obtained from a linear Analysis of Covariance (ANCOVA) model with fixed effects for treatment and Baseline antihypertensive use and a covariate for the Baseline number of nocturnal elevations of Systolic Blood Pressure that are associated with Periodic Limb Movements (PLMs).||-107.45|-213.23|<0.0001
72405864|NCT00739752|144320251|SUPERIORITY||Risk Ratio (RR)|0.99|||=|0.885|TWO_SIDED|95.0|0.88|1.12|||Regression, Poisson|||The two gain-framed groups were compared to the two loss-framed groups using poisson regression.||1.12|.88|=.885
72405865|NCT00739752|144320251|SUPERIORITY||Risk Ratio (RR)|1.17|||<|0.01|TWO_SIDED|95.0|1.06|1.31|||Regression, Poisson|||Groups receiving any framed interventions (gain-framed or loss-framed) were compared to those in the two non-framed control groups.||1.31|1.06|<.01
72405866|NCT00739752|144320251|SUPERIORITY||Risk Ratio (RR)|1.16|||<|0.01|TWO_SIDED|95.0|1.05|1.28|||Regression, Poisson|||The 3 vaccine-recommended groups were compared with the 3 vaccine-offered groups using poisson regression.||1.28|1.05|<.01
72405867|NCT01434290|144320252|SUPERIORITY|||||||0.19|||||||One sample z-test|One-sided 0.025 significance level||≤35% was considered acceptable, ≥55% unacceptable. Each arm analyzed separately. Average score and standard error of each arm calculated and one-sample z-test for proportion with significance level of 0.025 was used. For a given arm, if the null hypothesis of p ≤ 0.35 is rejected, then conclude that the regimen given on that arm is unacceptable. However if it not rejected for both bowel \& urinary domains, then that regimen will be considered acceptable for further use in a Phase III study.||||0.19
72569842|NCT02944383|144670015|SUPERIORITY|||||||0.6867||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.6867
72405868|NCT01434290|144320252|SUPERIORITY|||||||0.08|||||||One sample z-test|one-sided 0.025 significance level||≤35% was considered acceptable, ≥55% unacceptable. Each arm analyzed separately. Average score and standard error of each arm calculated and one-sample z-test for proportion with significance level of 0.025 was used. For a given arm, if the null hypothesis of p ≤ 0.35 is rejected, then conclude that the regimen given on that arm is unacceptable. However if it not rejected for both bowel \& urinary domains, then that regimen will be considered acceptable for further use in a Phase III study.||||0.08
72520919|NCT03803202|144570646|OTHER||Mean Difference|0.0||||0.984|TWO_SIDED|95.0|-0.4|0.4|||ANCOVA|||Serotype 4, Day 30||0.4|-0.4|0.984
72520920|NCT03803202|144570646|OTHER||Mean Difference|0.2||||0.262|TWO_SIDED|95.0|-0.2|0.6|||ANCOVA|||Serotype 4, Day 30||0.6|-0.2|0.262
72520921|NCT03803202|144570646|OTHER||Mean Difference|0.2||||0.264|TWO_SIDED|95.0|-0.2|0.6|||ANCOVA|||Serotype 4, Day 30||0.6|-0.2|0.264
72520922|NCT03803202|144570646|OTHER||Mean Difference|0.1||||0.638|TWO_SIDED|95.0|-0.4|0.6|||ANCOVA|||Serotype 5, Day 30||0.6|-0.4|0.638
72520923|NCT03803202|144570646|OTHER||Mean Difference|0.5||||0.036|TWO_SIDED|95.0|0.0|1.0|||ANCOVA|||Serotype 5, Day 30||1.0|0.0|0.036
72520924|NCT03803202|144570646|OTHER||Mean Difference|0.4||||0.094|TWO_SIDED|95.0|-0.1|0.9|||ANCOVA|||Serotype 5, Day 30||0.9|-0.1|0.094
72520925|NCT03803202|144570646|OTHER||Mean Difference|0.3||||0.266|TWO_SIDED|95.0|-0.2|0.8|||ANCOVA|||Serotype 6A, Day 30||0.8|-0.2|0.266
72520926|NCT03803202|144570646|OTHER||Mean Difference|0.3||||0.25|TWO_SIDED|95.0|-0.2|0.8|||ANCOVA|||Serotype 6A, Day 30||0.8|-0.2|0.250
72520927|NCT03803202|144570646|OTHER||Mean Difference|0.0||||0.927|TWO_SIDED|95.0|-0.5|0.5|||ANCOVA|||Serotype 6A, Day 30||0.5|-0.5|0.927
72520928|NCT03803202|144570646|OTHER||Mean Difference|-0.1||||0.679|TWO_SIDED|95.0|-0.5|0.3|||ANCOVA|||Serotype 6B, Day 30||0.3|-0.5|0.679
72520929|NCT03803202|144570646|OTHER||Mean Difference|-0.1||||0.589|TWO_SIDED|95.0|-0.6|0.3|||ANCOVA|||Serotype 6B, Day 30||0.3|-0.6|0.589
72520930|NCT03803202|144570646|OTHER||Mean Difference|0.0||||0.88|TWO_SIDED|95.0|-0.5|0.4|||ANCOVA|||Serotype 6B, Day 30||0.4|-0.5|0.880
72520931|NCT03803202|144570646|OTHER||Mean Difference|0.1||||0.623|TWO_SIDED|95.0|-0.2|0.4|||ANCOVA|||Serotype 7F, Day 30||0.4|-0.2|0.623
72520932|NCT03803202|144570646|OTHER||Mean Difference|0.2||||0.232|TWO_SIDED|95.0|-0.1|0.6|||ANCOVA|||Serotype 7F, Day 30||0.6|-0.1|0.232
72520933|NCT03803202|144570646|OTHER||Mean Difference|0.1||||0.451|TWO_SIDED|95.0|-0.2|0.5|||ANCOVA|||Serotype 7F, Day 30||0.5|-0.2|0.451
72520934|NCT03803202|144570646|OTHER||Mean Difference|0.0||||0.785|TWO_SIDED|95.0|-0.3|0.4|||ANCOVA|||Serotype 8, Day 30||0.4|-0.3|0.785
72520935|NCT03803202|144570646|OTHER||Mean Difference|0.8|||<|0.001|TWO_SIDED|95.0|0.4|1.1|||ANCOVA|||Serotype 8, Day 30||1.1|0.4|<.001
72520936|NCT03803202|144570646|OTHER||Mean Difference|0.7|||<|0.001|TWO_SIDED|95.0|0.4|1.1|||ANCOVA|||Serotype 8, Day 30||1.1|0.4|<.001
72520937|NCT03803202|144570646|OTHER||Mean Difference|0.2||||0.146|TWO_SIDED|95.0|-0.1|0.5|||ANCOVA|||Serotype 9N, Day 30||0.5|-0.1|0.146
72520938|NCT03803202|144570646|OTHER||Mean Difference|0.5||||0.003|TWO_SIDED|95.0|0.2|0.8|||ANCOVA|||Serotype 9N, Day 30||0.8|0.2|0.003
72520939|NCT03803202|144570646|OTHER||Mean Difference|0.3||||0.113|TWO_SIDED|95.0|-0.1|0.6|||ANCOVA|||Serotype 9N, Day 30||0.6|-0.1|0.113
72520940|NCT03803202|144570646|OTHER||Mean Difference|-0.2||||0.453|TWO_SIDED|95.0|-0.6|0.3|||ANCOVA|||Serotype 9V, Day 30||0.3|-0.6|0.453
72520941|NCT03803202|144570646|OTHER||Mean Difference|0.4||||0.111|TWO_SIDED|95.0|-0.1|0.8|||ANCOVA|||Serotype 9V, Day 30||0.8|-0.1|0.111
72520942|NCT03803202|144570646|OTHER||Mean Difference|0.5||||0.02|TWO_SIDED|95.0|0.1|1.0|||ANCOVA|||Serotype 9V, Day 30||1.0|0.1|0.020
72520943|NCT03803202|144570646|OTHER||Mean Difference|0.3||||0.218|TWO_SIDED|95.0|-0.2|0.8|||ANCOVA|||Serotype 10A, Day 30||0.8|-0.2|0.218
72520944|NCT03803202|144570646|OTHER||Mean Difference|0.4||||0.125|TWO_SIDED|95.0|-0.1|0.9|||ANCOVA|||Serotype 10A, Day 30||0.9|-0.1|0.125
72520945|NCT03803202|144570646|OTHER||Mean Difference|0.1||||0.706|TWO_SIDED|95.0|-0.4|0.6|||ANCOVA|||Serotype 10A, Day 30||0.6|-0.4|0.706
72520946|NCT03803202|144570646|OTHER||Mean Difference|0.2||||0.246|TWO_SIDED|95.0|-0.1|0.6|||ANCOVA|||Serotype 11A, Day 30||0.6|-0.1|0.246
72569843|NCT02944383|144670015|SUPERIORITY||Median Difference (Net)|9.07||||0.3156|TWO_SIDED|95.0|-12.22|36.34||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|EOS (average of week 10 and 12)||36.34|-12.22|0.3156
72569844|NCT02944383|144670015|SUPERIORITY||Median Difference (Net)|-0.3||||0.9734|TWO_SIDED|95.0|-24.58|25.43||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|EOS (average of week 10 and 12)||25.43|-24.58|0.9734
72520947|NCT03803202|144570646|OTHER||Mean Difference|0.7|||<|0.001|TWO_SIDED|95.0|0.3|1.1|||ANCOVA|||Serotype 11A, Day 30||1.1|0.3|<.001
72520948|NCT03803202|144570646|OTHER||Mean Difference|0.5||||0.01|TWO_SIDED|95.0|0.1|0.9|||ANCOVA|||Serotype 11A, Day 30||0.9|0.1|0.010
72520949|NCT03803202|144570646|OTHER||Mean Difference|-0.3||||0.26|TWO_SIDED|95.0|-0.7|0.2|||ANCOVA|||Serotype 12F, Day 30||0.2|-0.7|0.260
72520950|NCT03803202|144570646|OTHER||Mean Difference|0.2||||0.366|TWO_SIDED|95.0|-0.3|0.7|||ANCOVA|||Serotype 12F, Day 30||0.7|-0.3|0.366
72520951|NCT03803202|144570646|OTHER||Mean Difference|0.5||||0.046|TWO_SIDED|95.0|0.0|1.0|||ANCOVA|||Serotype 12F, Day 30||1.0|0.0|0.046
72520952|NCT03803202|144570646|OTHER||Mean Difference|-0.4||||0.101|TWO_SIDED|95.0|-0.8|0.1|||ANCOVA|||Serotype 14, Day 30||0.1|-0.8|0.101
72520953|NCT03803202|144570646|OTHER||Mean Difference|0.2||||0.522||95.0|-0.3|0.6|||ANCOVA|||Serotype 14, Day 30||0.6|-0.3|0.522
72520954|NCT03803202|144570646|OTHER||Mean Difference|0.5||||0.026|TWO_SIDED|95.0|0.1|1.0|||ANCOVA|||Serotype 14, Day 30||1.0|0.1|0.026
72520955|NCT03803202|144570646|OTHER||Mean Difference|-0.2||||0.236|TWO_SIDED|95.0|-0.6|0.2|||ANCOVA|||Serotype 15B, Day 30||0.2|-0.6|0.236
72520956|NCT03803202|144570646|OTHER||Mean Difference|0.1||||0.528|TWO_SIDED|95.0|-0.3|0.5|||ANCOVA|||Serotype 15B, Day 30||0.5|-0.3|0.528
72520957|NCT03803202|144570646|OTHER||Mean Difference|0.4||||0.081|TWO_SIDED|95.0|0.0|0.8|||ANCOVA|||Serotype 15B, Day 30||0.8|0.0|0.081
72520958|NCT03803202|144570646|OTHER||Mean Difference|-0.1||||0.388|TWO_SIDED|95.0|-0.5|0.2|||ANCOVA|||Serotype 17F, Day 30||0.2|-0.5|0.388
72520959|NCT03803202|144570646|OTHER||Mean Difference|0.3||||0.151|TWO_SIDED|95.0|-0.1|0.6|||ANCOVA|||Serotype 17F, Day 30||0.6|-0.1|0.151
72520960|NCT03803202|144570646|OTHER||Mean Difference|0.4||||0.024|TWO_SIDED|95.0|0.1|0.7|||ANCOVA|||Serotype 17F, Day 30||0.7|0.1|0.024
72520961|NCT03803202|144570646|OTHER||Mean Difference|0.1||||0.476|TWO_SIDED|95.0|-0.3|0.5|||ANCOVA|||Serotype 18C, Day 30||0.5|-0.3|0.476
72520962|NCT03803202|144570646|OTHER||Mean Difference|0.4||||0.077|TWO_SIDED|95.0|0.0|0.8|||ANCOVA|||Serotype 18C, Day 30||0.8|0.0|0.077
72520963|NCT03803202|144570646|OTHER||Mean Difference|0.2||||0.262|TWO_SIDED|95.0|-0.2|0.6|||ANCOVA|||Serotype 18C, Day 30||0.6|-0.2|0.262
72520964|NCT03803202|144570646|OTHER||Mean Difference|0.0||||0.767|TWO_SIDED|95.0|-0.3|0.4|||ANCOVA|||Serotype 19A, Day 30||0.4|-0.3|0.767
72520965|NCT03803202|144570646|OTHER||Mean Difference|0.2||||0.364|TWO_SIDED|95.0|-0.2|0.5|||ANCOVA|||Serotype 19A, Day 30||0.5|-0.2|0.364
72520966|NCT03803202|144570646|OTHER||Mean Difference|0.1||||0.522|TWO_SIDED|95.0|-0.2|0.5|||ANCOVA|||Serotype 19A, Day 30||0.5|-0.2|0.522
72405869|NCT01434290|144320253|SUPERIORITY|||||||0.18|||||||One sample z-test|One-sided 0.025 significance level||≤40% was considered acceptable, ≥60% unacceptable. Each arm analyzed separately. Average score and standard error of each arm calculated and one-sample z-test for proportion with significance level of 0.025 was used. For a given arm, if the null hypothesis of p ≤ 0.40 is rejected, then conclude that the regimen given on that arm is unacceptable. However if it not rejected for both bowel \& urinary domains, then that regimen will be considered acceptable for further use in a Phase III study.||||0.18
72405870|NCT01434290|144320253|SUPERIORITY|||||||0.38|||||||One sample z-test|One-sided 0.025 significance level||≤40% was considered acceptable, ≥60% unacceptable. Each arm analyzed separately. Average score and standard error of each arm calculated and one-sample z-test for proportion with significance level of 0.025 was used. For a given arm, if the null hypothesis of p ≤ 0.40 is rejected, then conclude that the regimen given on that arm is unacceptable. However if it not rejected for both bowel \& urinary domains, then that regimen will be considered acceptable for further use in a Phase III study.||||0.38
72405871|NCT01434290|144320258|SUPERIORITY|||||||0.03|||||||Wilcoxon (Mann-Whitney)|Two-sided significance level of 0.017.||\[Bowel one-year results\] Originally the t-test was planned to test if the change in each arm is different from 0. Wilcoxon Mann-Whitney was used instead due to the normality of the data.||||0.03
72405872|NCT01434290|144320258|SUPERIORITY|||||||0.03|||||||Wilcoxon (Mann-Whitney)|Two-sided significance level of 0.017.||\[Bowel one-year results\] Originally the t-test was planned to test if the change in each arm is different from 0. Wilcoxon Mann-Whitney was used instead due to the normality of the data.||||0.03
72405873|NCT01434290|144320258|SUPERIORITY|||||||0.09|||||||Wilcoxon (Mann-Whitney)|Two-sided significance level of 0.017||\[Urinary one-year results\] Originally the t-test was planned to test if the change in each arm is different from 0. Wilcoxon Mann-Whitney was used instead due to the normality of the data.||||0.09
72405874|NCT01434290|144320258|SUPERIORITY|||||||0.43|||||||Wilcoxon (Mann-Whitney)|Two-side significance level of 0.017||\[Urinary one-year results\] Originally the t-test was planned to test if the change in each arm is different from 0. Wilcoxon Mann-Whitney was used instead due to the normality of the data.||||0.43
72520967|NCT03803202|144570646|OTHER||Mean Difference|0.0||||0.962|TWO_SIDED|95.0|-0.4|0.4|||ANCOVA|||Serotype 19F, Day 30||0.4|-0.4|0.962
72405875|NCT01434290|144320259|SUPERIORITY|||||||0.39|||||||One-sample z-test|One-sided 0.025 significance level||≤35% was considered acceptable, ≥55% unacceptable. Each arm analyzed separately. Average score and standard error of each arm calculated and one-sample z-test for proportion with significance level of 0.025 was used.||||0.39
72405876|NCT01434290|144320259|SUPERIORITY|||||||0.21|||||||One sample z-test|One-side significance level of 0.025||≤35% was considered acceptable, ≥55% unacceptable. Each arm analyzed separately. Average score and standard error of each arm calculated and one-sample z-test for proportion with significance level of 0.025 was used.||||0.21
72405877|NCT01434290|144320260|SUPERIORITY|||||||0.44|||||||one sampe z-test|One-sided significance level of 0.025||≤38% was considered acceptable, ≥58% unacceptable. Each arm analyzed separately. Average score and standard error of each arm calculated and one-sample z-test for proportion with significance level of 0.025 was used.||||0.44
72405878|NCT01434290|144320260|SUPERIORITY|||||||0.53|||||||One sample z-test|One-sided significance level of 0.025||≤38% was considered acceptable, ≥58% unacceptable. Each arm analyzed separately. Average score and standard error of each arm calculated and one-sample z-test for proportion with significance level of 0.025 was used.||||0.53
72405879|NCT01434290|144320261|SUPERIORITY|||||||0.16|||||||Wilcoxon (Mann-Whitney)|Two-sided significance level of 0.017.||\[One-year Index Score\] Originally the t-test was planned to test if the change in each arm is different from 0. Wilcoxon Mann-Whitney was used instead due to the non-normality of the data. Each arm analyzed separately.||||0.16
72405880|NCT01434290|144320261|SUPERIORITY|||||||0.03|||||||Wilcoxon (Mann-Whitney)|Two-sided significance level of 0.017.||\[One-year Index Score\] Originally the t-test was planned to test if the change in each arm is different from 0. Wilcoxon Mann-Whitney was used instead due to the non-normality of the data. Each arm analyzed separately.||||0.03
72405881|NCT01434290|144320261|SUPERIORITY|||||||0.83|||||||Wilcoxon (Mann-Whitney)|Two-sided significance level of 0.017.||\[One-year VAS Score\] Originally the t-test was planned to test if the change in each arm is different from 0. Wilcoxon Mann-Whitney was used instead due to the non-normality of the data. Each arm analyzed separately.||||0.83
72405882|NCT01434290|144320261|SUPERIORITY|||||||0.86|||||||Wilcoxon (Mann-Whitney)|Two-sided significance level of 0.017.||\[One-year VAS Score\] Originally the t-test was planned to test if the change in each arm is different from 0. Wilcoxon Mann-Whitney was used instead due to the non-normality of the data. Each arm analyzed separately.||||0.86
72405883|NCT00558103|144320270|SUPERIORITY_OR_OTHER||Percentage of participants|29.0|||||TWO_SIDED|90.0|17.2|43.3|||||The estimated value represents the percentage of participants with CR and PR.|||43.3|17.2|
72405884|NCT00558103|144320270|SUPERIORITY_OR_OTHER||Percentage of participants|45.0|||||TWO_SIDED|90.0|30.9|59.3|||||The estimated value represents the percentage of participants with CR and PR.|||59.3|30.9|
72405885|NCT00558103|144320270|SUPERIORITY_OR_OTHER||Percentage of participants|47.0|||<|0.001|TWO_SIDED|90.0|32.8|62.1||Comparision of participants receiving lapatanib 1500 mg + placebo to historical control of 10% response rate|t-test, 1 sided||The estimated value represents the percentage of participants receiving lapatanib 1500 mg + placebo with CR and PR.|||62.1|32.8|<0.001
72520968|NCT03803202|144570646|OTHER||Mean Difference|0.3||||0.091|TWO_SIDED|95.0|-0.1|0.7|||ANCOVA|||Serotype 19F, Day 30||0.7|-0.1|0.091
72520969|NCT03803202|144570646|OTHER||Mean Difference|0.3||||0.093|TWO_SIDED|95.0|-0.1|0.7|||ANCOVA|||Serotype 19F, Day 30||0.7|-0.1|0.093
72520970|NCT03803202|144570646|OTHER||Mean Difference|-0.2||||0.455|TWO_SIDED|95.0|-0.6|0.3|||ANCOVA|||Serotype 20B, Day 30||0.3|-0.6|0.455
72520971|NCT03803202|144570646|OTHER||Mean Difference|0.4||||0.093|TWO_SIDED|95.0|-0.1|0.9|||ANCOVA|||Serotype 20B, Day 30||0.9|-0.1|0.093
72520972|NCT03803202|144570646|OTHER||Mean Difference|0.6||||0.017|TWO_SIDED|95.0|0.1|1.1|||ANCOVA|||Serotype 20B, Day 30||1.1|0.1|0.017
72520973|NCT03803202|144570646|OTHER||Mean Difference|-0.1||||0.561|TWO_SIDED|95.0|-0.5|0.3|||ANCOVA|||Serotype 22F, Day 30||0.3|-0.5|0.561
72520974|NCT03803202|144570646|OTHER||Mean Difference|0.2||||0.343|TWO_SIDED|95.0|-0.2|0.6|||ANCOVA|||Serotype 22F, Day 30||0.6|-0.2|0.343
72520975|NCT03803202|144570646|OTHER||Mean Difference|0.3||||0.132|TWO_SIDED|95.0|-0.1|0.7|||ANCOVA|||Serotype 22F, Day 30||0.7|-0.1|0.132
72520976|NCT03803202|144570646|OTHER||Mean Difference|0.0||||0.898|TWO_SIDED|95.0|-0.5|0.6|||ANCOVA|||Serotype 23F, Day 30||0.6|-0.5|0.898
72520977|NCT03803202|144570646|OTHER||Mean Difference|0.3||||0.313|TWO_SIDED|95.0|-0.3|0.9|||ANCOVA|||Serotype 23F, Day 30||0.9|-0.3|0.313
72520978|NCT03803202|144570646|OTHER||Mean Difference|0.3||||0.366|TWO_SIDED|95.0|-0.3|0.8|||ANCOVA|||Serotype 23F, Day 30||0.8|-0.3|0.366
72520979|NCT03803202|144570646|OTHER||Mean Difference|0.0||||0.961|TWO_SIDED|95.0|-0.4|0.4|||ANCOVA|||Serotype 33F, Day 30||0.4|-0.4|0.961
72520980|NCT03803202|144570646|OTHER||Mean Difference|0.2||||0.269|TWO_SIDED|95.0|-0.2|0.6|||ANCOVA|||Serotype 33F, Day 30||0.6|-0.2|0.269
72520981|NCT03803202|144570646|OTHER||Mean Difference|0.2||||0.245|TWO_SIDED|95.0|-0.2|0.6|||ANCOVA|||Serotype 33F, Day 30||0.6|-0.2|0.245
72520982|NCT03803202|144570647|OTHER||Mean Difference|0.3||||0.213|TWO_SIDED|95.0|-0.1|0.7|||ANCOVA|||Serotype 1, Day 30||0.7|-0.1|0.213
72520983|NCT03803202|144570647|OTHER||Mean Difference|0.4||||0.097|TWO_SIDED|95.0|-0.1|0.8|||ANCOVA|||Serotype 1, Day 30||0.8|-0.1|0.097
72520984|NCT03803202|144570647|OTHER||Mean Difference|0.1||||0.631|TWO_SIDED|95.0|-0.3|0.5|||ANCOVA|||Serotype 1, Day 30||0.5|-0.3|0.631
72520985|NCT03803202|144570647|OTHER||Mean Difference|0.1||||0.699|TWO_SIDED|95.0|-0.3|0.4|||ANCOVA|||Serotype 2, Day 30||0.4|-0.3|0.699
72520986|NCT03803202|144570647|OTHER||Mean Difference|0.4||||0.042|TWO_SIDED|95.0|0.0|0.7|||ANCOVA|||Serotype 2, Day 30||0.7|0.0|0.042
72520987|NCT03803202|144570647|OTHER||Mean Difference|0.3||||0.092|TWO_SIDED|95.0|-0.1|0.7|||ANCOVA|||Serotype 2, Day 30||0.7|-0.1|0.092
72520988|NCT03803202|144570647|OTHER||Mean Difference|0.5||||0.007|TWO_SIDED|95.0|0.1|0.8|||ANCOVA|||Serotype 3, Day 30||0.8|0.1|0.007
72520989|NCT03803202|144570647|OTHER||Mean Difference|0.7|||<|0.001|TWO_SIDED|95.0|0.3|1.0|||ANCOVA|||Serotype 3, Day 30||1.0|0.3|<.001
72624980|NCT02757768|144779458|SUPERIORITY||LS Mean of Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.1||0.223|TWO_SIDED|95.0|-0.2|0.1|||ANCOVA|||Week 4 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||0.1|-0.2|0.223
72520990|NCT03803202|144570647|OTHER||Mean Difference|0.2||||0.237|TWO_SIDED|95.0|-0.1|0.6|||ANCOVA|||Serotype 3, Day 30||0.6|-0.1|0.237
72520991|NCT03803202|144570647|OTHER||Mean Difference|0.2||||0.248|TWO_SIDED|95.0|-0.2|0.6|||ANCOVA|||Serotype 4, Day 30||0.6|-0.2|0.248
72520992|NCT03803202|144570647|OTHER||Mean Difference|0.3||||0.193|TWO_SIDED|95.0|-0.1|0.7|||ANCOVA|||Serotype 4, Day 30||0.7|-0.1|0.193
72520993|NCT03803202|144570647|OTHER||Mean Difference|0.0||||0.838|TWO_SIDED|95.0|-0.4|0.5|||ANCOVA|||Serotype 4, Day 30||0.5|-0.4|0.838
72520994|NCT03803202|144570647|OTHER||Mean Difference|0.0||||0.898|TWO_SIDED|95.0|-0.5|0.4|||ANCOVA|||Serotype 5, Day 30||0.4|-0.5|0.898
72520995|NCT03803202|144570647|OTHER||Mean Difference|0.4||||0.143|TWO_SIDED|95.0|-0.1|0.9|||ANCOVA|||Serotype 5, Day 30||0.9|-0.1|0.143
72520996|NCT03803202|144570647|OTHER||Mean Difference|0.4||||0.108|TWO_SIDED|95.0|-0.1|0.9|||ANCOVA|||Serotype 5, Day 30||0.9|-0.1|0.108
72520997|NCT03803202|144570647|OTHER||Mean Difference|0.2||||0.396|TWO_SIDED|95.0|-0.3|0.7|||ANCOVA|||Serotype 6A, Day 30||0.7|-0.3|0.396
72520998|NCT03803202|144570647|OTHER||Mean Difference|0.3||||0.182|TWO_SIDED|95.0|-0.2|0.9|||ANCOVA|||Serotype 6A, Day 30||0.9|-0.2|0.182
72520999|NCT03803202|144570647|OTHER||Mean Difference|0.1||||0.593|TWO_SIDED|95.0|-0.4|0.6|||ANCOVA|||Serotype 6A, Day 30||0.6|-0.4|0.593
72521000|NCT03803202|144570647|OTHER||Mean Difference|0.4||||0.186|TWO_SIDED|95.0|-0.2|0.9|||ANCOVA|||Serotype 6B, Day 30||0.9|-0.2|0.186
72521001|NCT03803202|144570647|OTHER||Mean Difference|0.6||||0.038|TWO_SIDED|95.0|0.0|1.1|||ANCOVA|||Serotype 6B, Day 30||1.1|0.0|0.038
72521002|NCT03803202|144570647|OTHER||Mean Difference|0.2||||0.408|TWO_SIDED|95.0|-0.3|0.8|||ANCOVA|||Serotype 6B, Day 30||0.8|-0.3|0.408
72521003|NCT03803202|144570647|OTHER||Mean Difference|0.1||||0.805|TWO_SIDED|95.0|-0.3|0.4|||ANCOVA|||Serotype 7F, Day 30||0.4|-0.3|0.805
72521004|NCT03803202|144570647|OTHER||Mean Difference|0.1||||0.711|TWO_SIDED|95.0|-0.3|0.5|||ANCOVA|||Serotype 7F, Day 30||0.5|-0.3|0.711
72521005|NCT03803202|144570647|OTHER||Mean Difference|0.0||||0.891|TWO_SIDED|95.0|-0.4|0.4|||ANCOVA|||Serotype 7F, Day 30||0.4|-0.4|0.891
72521006|NCT03803202|144570647|OTHER||Mean Difference|0.1||||0.649|TWO_SIDED|95.0|-0.3|0.4|||ANCOVA|||Serotype 8, Day 30||0.4|-0.3|0.649
72521007|NCT03803202|144570647|OTHER||Mean Difference|0.7|||<|0.001|TWO_SIDED|95.0|0.3|1.0|||ANCOVA|||Serotype 8, Day 30||1.0|0.3|<.001
72521008|NCT03803202|144570647|OTHER||Mean Difference|0.6|||<|0.001|TWO_SIDED|95.0|0.3|0.9|||ANCOVA|||Serotype 8, Day 30||0.9|0.3|<.001
72521009|NCT03803202|144570647|OTHER||Mean Difference|0.2||||0.454|TWO_SIDED|95.0|-0.2|0.5|||ANCOVA|||Serotype 9N, Day 30||0.5|-0.2|0.454
72521010|NCT03803202|144570647|OTHER||Mean Difference|0.6||||0.003|TWO_SIDED|95.0|0.2|1.0|||ANCOVA|||Serotype 9N, Day 30||1.0|0.2|0.003
72521011|NCT03803202|144570647|OTHER||Mean Difference|0.5||||0.021|TWO_SIDED|95.0|0.1|0.9|||ANCOVA|||Serotype 9N, Day 30||0.9|0.1|0.021
72521012|NCT03803202|144570647|OTHER||Mean Difference|0.3||||0.205|TWO_SIDED|95.0|-0.1|0.6|||ANCOVA|||Serotype 9V, Day 30||0.6|-0.1|0.205
72521013|NCT03803202|144570647|OTHER||Mean Difference|0.5||||0.015|TWO_SIDED|95.0|0.1|0.9|||ANCOVA|||Serotype 9V, Day 30||0.9|0.1|0.015
72521014|NCT03803202|144570647|OTHER||Mean Difference|0.3||||0.209|TWO_SIDED|95.0|-0.1|0.7|||ANCOVA|||Serotype 9V, Day 30||0.7|-0.1|0.209
72521015|NCT03803202|144570647|OTHER||Mean Difference|0.2||||0.502|TWO_SIDED|95.0|-0.3|0.6|||ANCOVA|||Serotype 10A, Day 30||0.6|-0.3|0.502
72521016|NCT03803202|144570647|OTHER||Mean Difference|0.5||||0.054|TWO_SIDED|95.0|0.0|1.0|||ANCOVA|||Serotype 10A, Day 30||1.0|0.0|0.054
72521017|NCT03803202|144570647|OTHER||Mean Difference|0.3||||0.19|TWO_SIDED|95.0|-0.2|0.8|||ANCOVA|||Serotype 10A, Day 30||0.8|-0.2|0.190
72521018|NCT03803202|144570647|OTHER||Mean Difference|0.1||||0.616|TWO_SIDED|95.0|-0.3|0.4|||ANCOVA|||Serotype 11A, Day 30||0.4|-0.3|0.616
72521019|NCT03803202|144570647|OTHER||Mean Difference|0.4||||0.018|TWO_SIDED|95.0|0.1|0.8|||ANCOVA|||Serotype 11A, Day 30||0.8|0.1|0.018
72405886|NCT00558103|144320270|SUPERIORITY_OR_OTHER||Percentage of participants|31.0|||||TWO_SIDED|90.0|11.3|57.3|||||The estimated value represents the percentage of participants with CR and PR.|||57.3|11.3|
72405887|NCT00558103|144320270|SUPERIORITY_OR_OTHER||Percentage of participants|58.0|||<|0.001|TWO_SIDED|90.0|43.3|71.5||Comparision of participants receiving lapatanib 1000 mg + pazopanib 400 mg to 10% historical response rate|t-test, 1 sided||The estimated value represents the percentage of participants receiving lapatanib 1000 mg + pazopanib 400 mg with CR and PR.|||71.5|43.3|<0.001
72521020|NCT03803202|144570647|OTHER||Mean Difference|0.4||||0.056|TWO_SIDED|95.0|0.0|0.7|||ANCOVA|||Serotype 11A, Day 30||0.7|0.0|0.056
72521021|NCT03803202|144570647|OTHER||Mean Difference|0.2||||0.527|TWO_SIDED|95.0|-0.4|0.7|||ANCOVA|||Serotype 12F, Day 30||0.7|-0.4|0.527
72521022|NCT03803202|144570647|OTHER||Mean Difference|0.2||||0.444|TWO_SIDED|95.0|-0.4|0.8|||ANCOVA|||Serotype 12F, Day 30||0.8|-0.4|0.444
72521023|NCT03803202|144570647|OTHER||Mean Difference|0.0||||0.869|TWO_SIDED|95.0|-0.5|0.6|||ANCOVA|||Serotype 12F, Day 30||0.6|-0.5|0.869
72521024|NCT03803202|144570647|OTHER||Mean Difference|0.3||||0.305|TWO_SIDED|95.0|-0.2|0.7|||ANCOVA|||Serotype 14, Day 30||0.7|-0.2|0.305
72521025|NCT03803202|144570647|OTHER||Mean Difference|0.5||||0.046|TWO_SIDED|95.0|0.0|1.0|||ANCOVA|||Serotype 14, Day 30||1.0|0.0|0.046
72521026|NCT03803202|144570647|OTHER||Mean Difference|0.3||||0.299|TWO_SIDED|95.0|-0.2|0.8|||ANCOVA|||Serotype 14, Day 30||0.8|-0.2|0.299
72521027|NCT03803202|144570647|OTHER||Mean Difference|0.3||||0.14|TWO_SIDED|95.0|-0.1|0.7|||ANCOVA|||Serotype 15B, Day 30||0.7|-0.1|0.140
72521028|NCT03803202|144570647|OTHER||Mean Difference|0.9|||<|0.001|TWO_SIDED|95.0|0.4|1.3|||ANCOVA|||Serotype 15B, Day 30||1.3|0.4|<.001
72569845|NCT02944383|144670016|SUPERIORITY|||||||0.9772||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.9772
72569846|NCT02944383|144670016|SUPERIORITY|||||||0.5213||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.5213
72405888|NCT00558103|144320270|SUPERIORITY_OR_OTHER||Difference in percentage of participants|11.0||||0.485|TWO_SIDED|90.0|-8.3|29.7|||Fisher Exact||The estimated value represents the percent difference in the percentage of participants with CR and PR.|||29.7|-8.3|0.485
72405889|NCT00558103|144320270|SUPERIORITY_OR_OTHER||Difference in percentage of participants|27.0||||0.116|TWO_SIDED|90.0|2.3|52.0|||Fisher Exact||The estimated value represents the percent difference in the percentage of participants with CR and PR.|||52.0|2.3|0.116
72405890|NCT03993938|144320279|OTHER|Delta PVI percentage change and Delta LAP (v-wave) percentage change were correlated using Spearman's rank correlation - two-tailed.|Spearman's rank correlation|0.34||||0.066|TWO_SIDED||||||Spearman's rank correlation|||||||0.066
72521029|NCT03803202|144570647|OTHER||Mean Difference|0.6||||0.012|TWO_SIDED|95.0|0.1|1.0|||ANCOVA|||Serotype 15B, Day 30||1.0|0.1|0.012
72521030|NCT03803202|144570647|OTHER||Mean Difference|0.2||||0.2|TWO_SIDED|95.0|-0.1|0.6|||ANCOVA|||Serotype 17F, Day 30||0.6|-0.1|0.200
72521031|NCT03803202|144570647|OTHER||Mean Difference|0.4||||0.037|TWO_SIDED|95.0|0.0|0.8|||ANCOVA|||Serotype 17F, Day 30||0.8|0.0|0.037
72405891|NCT02434770|144320282|EQUIVALENCE|Primary efficacy objective 1 of this study was to demonstrate the equivalence of two lots of BBIBP bOPV in terms of post-vaccination anti-polio neutralizing antibody GMTs. The immune response of the two lots of BBIBP bOPV would be declared equivalent if the 95% confidence interval (CI) for the serotype-specific GMT ratio for both serotypes was contained within (0.5, 2.0).|Ratio of Geometric Mean Titers|0.84|||||TWO_SIDED|95.0|0.65|1.08|||||Lot 1 / Lot 2|||1.08|0.65|
72521032|NCT03803202|144570647|OTHER||Mean Difference|0.2||||0.38|TWO_SIDED|95.0|-0.2|0.6|||ANCOVA|||Serotype 17F, Day 30||0.6|-0.2|0.380
72521033|NCT03803202|144570647|OTHER||Mean Difference|0.6||||0.006|TWO_SIDED|95.0|0.2|1.0|||ANCOVA|||Serotype 18C, Day 30||1.0|0.2|0.006
72521034|NCT03803202|144570647|OTHER||Mean Difference|0.5||||0.018|TWO_SIDED|95.0|0.1|1.0|||ANCOVA|||Serotype 18C, Day 30||1.0|0.1|0.018
72521035|NCT03803202|144570647|OTHER||Mean Difference|-0.1||||0.81|TWO_SIDED|95.0|-0.5|0.4|||ANCOVA|||Serotype 18C, Day 30||0.4|-0.5|0.810
72521036|NCT03803202|144570647|OTHER||Mean Difference|0.3||||0.173|TWO_SIDED|95.0|-0.1|0.7|||ANCOVA|||Serotype 19A, Day 30||0.7|-0.1|0.173
72521037|NCT03803202|144570647|OTHER||Mean Difference|0.4||||0.096|TWO_SIDED|95.0|-0.1|0.8|||ANCOVA|||Serotype 19A, Day 30||0.8|-0.1|0.096
72521038|NCT03803202|144570647|OTHER||Mean Difference|0.1||||0.71|TWO_SIDED|95.0|-0.3|0.5|||ANCOVA|||Serotype 19A, Day 30||0.5|-0.3|0.710
72521039|NCT03803202|144570647|OTHER||Mean Difference|0.4||||0.1|TWO_SIDED|95.0|-0.1|0.8|||ANCOVA|||Serotype 19F, Day 30||0.8|-0.1|0.100
72521040|NCT03803202|144570647|OTHER||Mean Difference|0.6||||0.007|TWO_SIDED|95.0|0.2|1.1|||ANCOVA|||Serotype 19F, Day 30||1.1|0.2|0.007
72521041|NCT03803202|144570647|OTHER||Mean Difference|0.3||||0.251|TWO_SIDED|95.0|-0.2|0.7|||ANCOVA|||Serotype 19F, Day 30||0.7|-0.2|0.251
72521042|NCT03803202|144570647|OTHER||Mean Difference|0.1||||0.618|TWO_SIDED|95.0|-0.3|0.5|||ANCOVA|||Serotype 20B, Day 30||0.5|-0.3|0.618
72521043|NCT03803202|144570647|OTHER||Mean Difference|0.5||||0.041|TWO_SIDED|95.0|0.0|0.9|||ANCOVA|||Serotype 20B, Day 30||0.9|0.0|0.041
72521044|NCT03803202|144570647|OTHER||Mean Difference|0.3||||0.111|TWO_SIDED|95.0|-0.1|0.8|||ANCOVA|||Serotype 20B, Day 30||0.8|-0.1|0.111
72521045|NCT03803202|144570647|OTHER||Mean Difference|0.1||||0.758|TWO_SIDED|95.0|-0.3|0.4|||ANCOVA|||Serotype 22F, Day 30||0.4|-0.3|0.758
72521046|NCT03803202|144570647|OTHER||Mean Difference|0.5||||0.012|TWO_SIDED|95.0|0.1|0.9|||ANCOVA|||Serotype 22F, Day 30||0.9|0.1|0.012
72521047|NCT03803202|144570647|OTHER||Mean Difference|0.4||||0.025|TWO_SIDED|95.0|0.1|0.8|||ANCOVA|||Serotype 22F, Day 30||0.8|0.1|0.025
72521048|NCT03803202|144570647|OTHER||Mean Difference|0.0||||0.912|TWO_SIDED|95.0|-0.5|0.4|||ANCOVA|||Serotype 23F, Day 30||0.4|-0.5|0.912
72569847|NCT02944383|144670016|SUPERIORITY|||||||0.1582||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.1582
72521049|NCT03803202|144570647|OTHER||Mean Difference|0.3||||0.174|TWO_SIDED|95.0|-0.1|0.8|||ANCOVA|||Serotype 23F, Day 30||0.8|-0.1|0.174
72521050|NCT03803202|144570647|OTHER||Mean Difference|0.3||||0.138|TWO_SIDED|95.0|-0.1|0.8|||ANCOVA|||Serotype 23F, Day 30||0.8|-0.1|0.138
72521051|NCT03803202|144570647|OTHER||Mean Difference|0.2||||0.267|TWO_SIDED|95.0|-0.2|0.7|||ANCOVA|||Serotype 33F, Day 30||0.7|-0.2|0.267
72521052|NCT03803202|144570647|OTHER||Mean Difference|0.2||||0.3|TWO_SIDED|95.0|-0.2|0.7|||ANCOVA|||Serotype 33F, Day 30||0.7|-0.2|0.300
72521053|NCT03803202|144570647|OTHER||Mean Difference|0.0||||0.982|TWO_SIDED|95.0|-0.4|0.4|||ANCOVA|||Serotype 33F, Day 30||0.4|-0.4|0.982
72521054|NCT03803202|144570648|OTHER||Ratio of GMT|1.49|||||TWO_SIDED|95.0|1.06|2.08|||t-test, 2 sided|||Serotype 2||2.08|1.06|
72521055|NCT03803202|144570648|OTHER||Ratio of GMT|0.97|||||TWO_SIDED|95.0|0.68|1.37|||t-test, 2 sided|||Serotype 8||1.37|0.68|
72521056|NCT03803202|144570648|OTHER||Ratio of GMT|1.35|||||TWO_SIDED|95.0|0.92|2.0|||t-test, 2 sided|||Serotype 9N||2.00|0.92|
72521057|NCT03803202|144570648|OTHER||Ratio of GMT|2.18|||||TWO_SIDED|95.0|1.25|3.79|||t-test, 2 sided|||Serotype 10A||3.79|1.25|
72521058|NCT03803202|144570648|OTHER||Ratio of GMT|1.19|||||TWO_SIDED|95.0|0.8|1.77|||t-test, 2 sided|||Serotype 11A||1.77|0.80|
72569848|NCT02944383|144670016|SUPERIORITY|||||||0.4588||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.4588
72521059|NCT03803202|144570648|OTHER||Ratio of GMT|1.2|||||TWO_SIDED|95.0|0.73|2.0|||t-test, 2 sided|||Serotype 12F||2.00|0.73|
72521060|NCT03803202|144570648|OTHER||Ratio of GMT|1.47|||||TWO_SIDED|95.0|0.94|2.29|||t-test, 2 sided|||Serotype 15B||2.29|0.94|
72521061|NCT03803202|144570648|OTHER||Ratio of GMT|2.61|||||TWO_SIDED|95.0|1.68|4.04|||t-test, 2 sided|||Serotype 17F||4.04|1.68|
72521062|NCT03803202|144570648|OTHER||Ratio of GMT|9.05|||||TWO_SIDED|95.0|5.65|14.5|||t-test, 2 sided|||Serotype 20B||14.50|5.65|
72521063|NCT03803202|144570648|OTHER||Ratio of GMT|1.79|||||TWO_SIDED|95.0|1.09|2.95|||t-test, 2 sided|||Serotype 22F||2.95|1.09|
72521064|NCT03803202|144570648|OTHER|Serotype 33F|Ratio of GMT|1.34|||||TWO_SIDED|95.0|0.86|2.11|||t-test, 2 sided|||||2.11|0.86|
72521065|NCT03803202|144570648|OTHER||Ratio of GMT|1.31|||||TWO_SIDED|95.0|0.93|1.83|||t-test, 2 sided|||Serotype 2||1.83|0.93|
72521066|NCT03803202|144570648|OTHER||Ratio of GMT|0.98|||||TWO_SIDED|95.0|0.67|1.43|||t-test, 2 sided|||Serotype 8||1.43|0.67|
72569849|NCT02944383|144670016|SUPERIORITY|||||||0.4264||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||EOS (average of week 10 and 12)||||0.4264
72521067|NCT03803202|144570648|OTHER||Ratio of GMT|1.62|||||TWO_SIDED|95.0|1.62|2.26|||t-test, 2 sided|||Serotype 9N||2.26|1.62|
72521068|NCT03803202|144570648|OTHER||Ratio of GMT|2.87|||||TWO_SIDED|95.0|1.68|4.9|||t-test, 2 sided|||Serotype 10A||4.90|1.68|
72521069|NCT03803202|144570648|OTHER||Ratio of GMT|1.42|||||TWO_SIDED|95.0|0.98|2.06|||t-test, 2 sided|||Serotype 11A||2.06|0.98|
72521070|NCT03803202|144570648|OTHER||Ratio of GMT|0.9|||||TWO_SIDED|95.0|0.54|1.48|||t-test, 2 sided|||Serotype 12F||1.48|0.54|
72521071|NCT03803202|144570648|OTHER||Ratio of GMT|1.09|||||TWO_SIDED|95.0|0.73|1.64|||t-test, 2 sided|||Serotype 15B||1.64|0.73|
72521072|NCT03803202|144570648|OTHER||Ratio of GMT|2.13|||||TWO_SIDED|95.0|1.4|3.25|||t-test, 2 sided|||Serotype 17F||3.25|1.40|
72521073|NCT03803202|144570648|OTHER||Ratio of GMT|7.28|||||TWO_SIDED|95.0|4.61|11.5|||t-test, 2 sided|||Serotype 20B||11.50|4.61|
72521074|NCT03803202|144570648|OTHER||Ratio of GMT|1.55|||||TWO_SIDED|95.0|0.96|2.48|||t-test, 2 sided|||Serotype 22F||2.48|0.96|
72521075|NCT03803202|144570648|OTHER||Ratio of GMT|1.24|||||TWO_SIDED|95.0|0.83|1.84|||t-test, 2 sided|||Serotype 33F||1.84|0.83|
72521076|NCT03803202|144570648|OTHER||Ratio of GMT|2.1|||||TWO_SIDED|95.0|1.51|2.94|||t-test, 2 sided|||Serotype 2||2.94|1.51|
72521077|NCT03803202|144570648|OTHER||Ratio of GMT|2.08|||||TWO_SIDED|95.0|1.46|2.97|||t-test, 2 sided|||Serotype 8||2.97|1.46|
72521078|NCT03803202|144570648|OTHER||Ratio of GMT|2.24|||||TWO_SIDED|95.0|1.56|3.2|||t-test, 2 sided|||Serotype 9N||3.20|1.56|
72521079|NCT03803202|144570648|OTHER||Ratio of GMT|3.24|||||TWO_SIDED|95.0|1.79|5.89|||t-test, 2 sided|||Serotype 10A||5.89|1.79|
72521080|NCT03803202|144570648|OTHER||Ratio of GMT|2.43|||||TWO_SIDED|95.0|1.63|3.62|||t-test, 2 sided|||Serotype 11A||3.62|1.63|
72521081|NCT03803202|144570648|OTHER||Ratio of GMT|1.51|||||TWO_SIDED|95.0|0.89|2.55|||t-test, 2 sided|||Serotype 12 F||2.55|0.89|
72521082|NCT03803202|144570648|OTHER||Ratio of GMT|1.69|||||TWO_SIDED|95.0|1.11|2.57|||t-test, 2 sided|||Serotype 15B||2.57|1.11|
72521083|NCT03803202|144570648|OTHER||Ratio of GMT|3.37|||||TWO_SIDED|95.0|2.18|5.2|||t-test, 2 sided|||Serotype 17F||5.20|2.18|
72521084|NCT03803202|144570648|OTHER||Ratio of GMT|13.7|||||TWO_SIDED|95.0|8.26|22.72|||t-test, 2 sided|||Serotype 20B||22.72|8.26|
72521085|NCT03803202|144570648|OTHER||Ratio of GMT|2.17|||||TWO_SIDED|95.0|1.36|3.46|||t-test, 2 sided|||Serotype 22F||3.46|1.36|
72521086|NCT03803202|144570648|OTHER||Ratio of GMT|1.69|||||TWO_SIDED|95.0|1.11|2.57|||t-test, 2 sided|||Serotype 33F||2.57|1.11|
72521087|NCT03803202|144570649|OTHER||Ratio of GMT|1.35|||||TWO_SIDED|95.0|0.95|1.93|||t-test, 2 sided|||Serotype 2||1.93|0.95|
72521088|NCT03803202|144570649|OTHER||Ratio of GMT|1.51|||||TWO_SIDED|95.0|1.07|2.13|||t-test, 2 sided|||Serotype 8||2.13|1.07|
72521089|NCT03803202|144570649|OTHER||Ratio of GMT|1.59|||||TWO_SIDED|95.0|1.09|2.33|||t-test, 2 sided|||Serotype 9N||2.33|1.09|
72521090|NCT03803202|144570649|OTHER||Ratio of GMT|2.24|||||TWO_SIDED|95.0|1.45|3.47|||t-test, 2 sided|||Serotype 10A||3.47|1.45|
72521091|NCT03803202|144570649|OTHER||Ratio of GMT|1.83|||||TWO_SIDED|95.0|1.27|2.65|||t-test, 2 sided|||Serotype 11A||2.65|1.27|
72521092|NCT03803202|144570649|OTHER||Ratio of GMT|1.31|||||TWO_SIDED|95.0|0.77|2.23|||t-test, 2 sided|||Serotype 12F||2.23|0.77|
72521093|NCT03803202|144570649|OTHER||Ratio of GMT|1.24|||||TWO_SIDED|95.0|0.8|1.91|||t-test, 2 sided|||Serotype 15B||1.91|0.80|
72521094|NCT03803202|144570649|OTHER||Ratio of GMT|2.63|||||TWO_SIDED|95.0|1.7|4.07|||t-test, 2 sided|||Serotype 17F||4.07|1.70|
72521095|NCT03803202|144570649|OTHER||Ratio of GMT|2.43|||||TWO_SIDED|95.0|1.61|3.67|||t-test, 2 sided|||Serotype 20B||3.67|1.61|
72521096|NCT03803202|144570649|OTHER||Ratio of GMT|2.49|||||TWO_SIDED|95.0|1.7|3.65|||t-test, 2 sided|||Serotype 22F||3.65|1.70|
72521097|NCT03803202|144570649|OTHER||Ratio of GMT|1.67|||||TWO_SIDED|95.0|1.1|2.54|||t-test, 2 sided|||Serotype 33F||2.54|1.10|
72521098|NCT03803202|144570649|OTHER||Ratio of GMT|1.42|||||TWO_SIDED|95.0|0.98|2.07|||t-test, 2 sided|||Serotype 2||2.07|0.98|
72521099|NCT03803202|144570649|OTHER||Ratio of GMT|1.58|||||TWO_SIDED|95.0|1.11|2.26|||t-test, 2 sided|||Serotype 8||2.26|1.11|
72521100|NCT03803202|144570649|OTHER||Ratio of GMT|1.83|||||TWO_SIDED|95.0|1.23|2.72|||t-test, 2 sided|||Serotype 9N||2.72|1.23|
72521101|NCT03803202|144570649|OTHER||Ratio of GMT|2.59|||||TWO_SIDED|95.0|1.66|4.05||||||Serotype 10A||4.05|1.66|
72521102|NCT03803202|144570649|OTHER||Ratio of GMT|1.9|||||TWO_SIDED|95.0|1.32|2.73|||t-test, 2 sided|||Serotype 11A||2.73|1.32|
72521103|NCT03803202|144570649|OTHER||Ratio of GMT|1.59|||||TWO_SIDED|95.0|0.93|2.71|||t-test, 2 sided|||Serotype 12F||2.71|0.93|
72521104|NCT03803202|144570649|OTHER||Ratio of GMT|1.68|||||TWO_SIDED|95.0|1.11|2.53|||t-test, 2 sided|||Serotype 15B||2.53|1.11|
72521105|NCT03803202|144570649|OTHER||Ratio of GMT|3.27|||||TWO_SIDED|95.0|2.17|4.93|||t-test, 2 sided|||Serotype 17F||4.93|2.17|
72521106|NCT03803202|144570649|OTHER||Ratio of GMT|2.79|||||TWO_SIDED|95.0|1.85|4.22|||t-test, 2 sided|||Serotype 20B||4.22|1.85|
72521107|NCT03803202|144570649|OTHER||Ratio of GMT|2.63|||||TWO_SIDED|95.0|1.79|3.88|||t-test, 2 sided|||Serotype 22F||3.88|1.79|
72521108|NCT03803202|144570649|OTHER||Ratio of GMT|2.05|||||TWO_SIDED|95.0|1.4|3.01|||t-test, 2 sided|||Serotype 33F||3.01|1.40|
72521109|NCT03803202|144570649|OTHER||Ratio of GMT|1.97|||||TWO_SIDED|95.0|1.37|2.84|||t-test, 2 sided|||Serotype 2||2.84|1.37|
72521110|NCT03803202|144570649|OTHER||Ratio of GMT|2.98|||||TWO_SIDED|95.0|2.12|4.18|||t-test, 2 sided|||Serotype 8||4.18|2.12|
72521111|NCT03803202|144570649|OTHER||Ratio of GMT|2.99|||||TWO_SIDED|95.0|2.02|4.44|||t-test, 2 sided|||Serotype 9N||4.44|2.02|
72569850|NCT02944383|144670016|SUPERIORITY|||||||0.8107||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||EOS (average of week 10 and 12)||||0.8107
72521112|NCT03803202|144570649|OTHER||Ratio of GMT|3.63|||||TWO_SIDED|95.0|2.25|5.86|||t-test, 2 sided|||Serotype 10A||5.86|2.25|
72521113|NCT03803202|144570649|OTHER||Ratio of GMT|2.86|||||TWO_SIDED|95.0|1.96|4.18|||t-test, 2 sided|||Serotype 11A||4.18|1.96|
72521114|NCT03803202|144570649|OTHER||Ratio of GMT|1.64|||||TWO_SIDED|95.0|0.91|2.96|||t-test, 2 sided|||Serotype 12F||2.96|0.91|
72521115|NCT03803202|144570649|OTHER||Ratio of GMT|2.93|||||TWO_SIDED|95.0|1.87|4.61|||t-test, 2 sided|||Serotype 15B||4.61|1.87|
72521116|NCT03803202|144570649|OTHER||Ratio of GMT|4.0|||||TWO_SIDED|95.0|2.55|6.26|||t-test, 2 sided|||Serotype 17F||6.26|2.55|
72521117|NCT03803202|144570649|OTHER||Ratio of GMT|3.82|||||TWO_SIDED|95.0|2.46|5.91|||t-test, 2 sided|||Serotype 22F||5.91|2.46|
72521118|NCT03803202|144570649|OTHER||Ratio of GMT|4.02|||||TWO_SIDED|95.0|2.74|5.9|||t-test, 2 sided|||Serotype 22F||5.90|2.74|
72521119|NCT03803202|144570649|OTHER||Ratio of GMT|2.11|||||TWO_SIDED|95.0|1.38|3.23|||t-test, 2 sided|||Serotype 33F||3.23|1.38|
72521120|NCT00293241|144570650|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.927||||0.72|TWO_SIDED|95.0|0.612|1.405|||Log Rank||"Hospitalization:hospital admission with overnight stay;ER/office visits with cardioversions;acute treatment of worsened cardiac condition~CV:new/worsening HF,angina,MI,arrhythmia,stroke, TIA,acute peripheral vascular emergencies,pulmonary embolism"|"Analysis:Time to first cardiovascular hospitalization (CV hosp)~H0:freedom from CV hosp MVP=freedom from CV hosp DDD (dual chamber conventional pacing)~Ha:freedom from CV hosp MVP≠freedom from CV hosp DDD~Power calculation:~The study is designed to detect a difference event-free survival after 2 years of 5.5 % absolute, going from 91.5% to 97%.~Test=two-sided alpha=0.05 power=80% 1:1 randomization n=600"||1.405|0.612|0.72
72521121|NCT00293241|144570651|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.127||||0.48|TWO_SIDED|95.0|0.808|1.57|||Log Rank|||"Analysis:Time to first all cause death or cardiovascular hospitalization~H0:freedom from death or CV hospitalization=freedom from death or CV hospitalization~Ha:freedom from death or CV hospitalization≠freedom from death or CV hospitalization"||1.570|0.808|0.48
72521122|NCT00293241|144570652|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.521||||0.08|TWO_SIDED|95.0|0.954|2.424|||Log Rank|||Analysis:Time to first persistent AT/AF H0:freedom from persistent AT/AF=freedom from persistent AT/AF Ha:freedom from persistent AT/AF≠freedom from persistent AT/AF||2.424|0.954|0.08
72521123|NCT00293241|144570653|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.425||||0.44|TWO_SIDED|95.0|0.573|3.543|||Log Rank|||Analysis:Time to permanent AF H0:freedom from permanent AF=freedom from permanent AF Ha:freedom from permanent AF≠freedom from permanent AF||3.543|0.573|0.44
72521124|NCT00293241|144570654|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||"Analysis:Wilcoxon Test for Comparison of Percentage of Ventricular Pacing (%VP) During Followup by Randomization Arm~H0:distribution %VP MVP=distribution %VP DDD~Ha:distribution %VP MVP≠distribution %VP DDD~Ha:"||||<0.0001
72521125|NCT00293241|144570655|SUPERIORITY_OR_OTHER|||||||0.048|TWO_SIDED||||||Regression, Linear|||||||0.048
72521126|NCT00293241|144570657|SUPERIORITY_OR_OTHER|||||||0.78|TWO_SIDED|95.0|||||Repeated measures logistic regression|||Analysis:Repeated measures logistic regression||||0.78
72521127|NCT00293241|144570658|SUPERIORITY_OR_OTHER|||||||0.34|TWO_SIDED||||||Regression, Logistic|||Analysis:Repeated measures logistic regression H0:Change in Beta-blockers=Change in Beta-blockers Ha:Change in Beta-blockers≠Change in Beta-blockers||||0.34
72521128|NCT00293241|144570658|SUPERIORITY_OR_OTHER|||||||0.65|TWO_SIDED||||||Regression, Logistic|||Analysis:Repeated measures logistic regression H0:Change in Digitalis/digoxin=Change in Digitalis/digoxin Ha:Change in Digitalis/digoxin≠Change in Digitalis/digoxin||||0.65
72521129|NCT00293241|144570658|SUPERIORITY_OR_OTHER|||||||0.55|TWO_SIDED||||||Regression, Logistic|||Analysis:Repeated measures logistic regression H0:Change in Calcium antagonists=Change in Calcium antagonists Ha:Change in Calcium antagonists≠Change in Calcium antagonists||||0.55
72521130|NCT00293241|144570658|SUPERIORITY_OR_OTHER|||||||0.53|TWO_SIDED||||||Regression, Logistic|||Analysis:Repeated measures logistic regression H0:Change in Antiarrhythmic drug=Change in Antiarrhythmic drug Ha:Change in Antiarrhythmic drug≠Change in Antiarrhythmic drug||||0.53
72521131|NCT00293241|144570660|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.243||||0.33|TWO_SIDED|95.0|0.803|1.923|||Log Rank|||"Analysis:Time to all-cause death~H0:survival MVP ON=survival MVP OFF Ha:survival MVP ON≠survival MVP OFF"||1.923|0.803|0.33
72521132|NCT00293241|144570661|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.492||||0.24|TWO_SIDED|95.0|0.148|1.637|||Log Rank|||||1.637|0.148|0.24
72521133|NCT00293241|144570662|SUPERIORITY_OR_OTHER|||||||0.83|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Statistical test for Number of subjects with CV hospitalization||||0.83
72521134|NCT00293241|144570665|SUPERIORITY_OR_OTHER|||||||0.34|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||H0:Change in P-R interval=Change in P-R interval Ha:Change in P-R interval≠Change in P-R interval||||0.34
72521135|NCT00293241|144570665|SUPERIORITY_OR_OTHER|||||||0.19|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||H0:Change in QRS duration=Change in QRS duration Ha:Change in QRS duration≠Change in QRS duration||||0.19
72521136|NCT00293241|144570665|SUPERIORITY_OR_OTHER|||||||0.29|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||H0:Change in P-wave duration=Change in P-wave duration Ha:Change in P-wave duration≠Change in P-wave duration||||0.29
72521137|NCT00293241|144570666|SUPERIORITY_OR_OTHER|||||||0.24|TWO_SIDED|95.0|||||Fisher Exact|||No Symptoms (Baseline)||||0.24
72521138|NCT00293241|144570666|SUPERIORITY_OR_OTHER|||||||0.92|TWO_SIDED||||||Fisher Exact|||No Symptoms (12 months)||||0.92
72521139|NCT00293241|144570666|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Fisher Exact|||No Symptoms (24 Months)||||1.0
72569851|NCT02944383|144670017|SUPERIORITY||Odds Ratio (OR)|5.38||||0.0093|TWO_SIDED|95.0|1.51|19.08||Logistic regression results are obtained using a model with randomized treatment group, randomized baseline statin (yes or no), and baseline TG value as independent factors.|Regression, Logistic||The OR is an estimate of the odds of achieving a TG value \< 500 mg/dL associated with the corresponding Gemcabene group relative to the placebo group at a given visit.|Week 10||19.08|1.51|0.0093
72569852|NCT02944383|144670017|SUPERIORITY||Odds Ratio (OR)|2.57||||0.107|TWO_SIDED|95.0|0.82|8.07||Logistic regression results are obtained using a model with randomized treatment group, randomized baseline statin (yes or no), and baseline TG value as independent factors.|Regression, Logistic||The OR is an estimate of the odds of achieving a TG value \< 500 mg/dL associated with the corresponding Gemcabene group relative to the placebo group at a given visit.|Week 10||8.07|0.82|0.1070
72521140|NCT00293241|144570667|SUPERIORITY_OR_OTHER|||||||0.03|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||0.03
72521141|NCT01216397|144570683|SUPERIORITY_OR_OTHER||adjusted gMean ratio|99.4||||||90.0|94.2|105.0|||ANOVA|||Standard batch vs. Side batch||105.0|94.2|
72521142|NCT01216397|144570684|SUPERIORITY_OR_OTHER||adjusted gMean ratio|100.1||||||90.0|96.1|104.2|||ANOVA|||Standard batch vs. Side batch||104.2|96.1|
72521143|NCT01216397|144570685|SUPERIORITY_OR_OTHER||adjusted gMean ratio|100.1||||||90.0|94.7|105.8|||ANOVA|||Standard batch vs. Side batch||105.8|94.7|
72521144|NCT01216397|144570693|SUPERIORITY_OR_OTHER||adjusted gMean ratio|97.9||||||90.0|92.5|103.7|||ANOVA|||Standard batch vs. Side batch||103.7|92.5|
72521145|NCT01216397|144570694|SUPERIORITY_OR_OTHER||adjusted gMean ratio|100.4||||||90.0|95.7|105.4|||ANOVA|||||105.4|95.7|
72521146|NCT01216397|144570695|SUPERIORITY_OR_OTHER||adjusted gMean ratio|100.3||||||90.0|95.7|105.2|||ANOVA|||Standard batch vs. Side batch||105.2|95.7|
72521147|NCT02925312|144570708|SUPERIORITY|||||||0.05|||||||McNemar|||The study was powered to detect a difference of 0.5 in the change in HbA1c with SD=2 with 80% power at alpha=0.05 with a sample size of 128 in each group (paired t-test). Differences in patient characteristics and the unadjusted differences in the outcome measures between the intervention and control groups were tested using linear mixed models, McNemar tests and conditional logistic models due to matching.||||0.05
72521148|NCT00971633|144570720|NON_INFERIORITY_OR_EQUIVALENCE|Study Secondary Hypothesis: A single dose of U.K. ZOFRAN (ondansetron) 8-mg table over-encapsulated is bioequivalent to a single dose of the U.K. ZOFRAN (ondansetron) 8-mg tablet. That is, the true geometric mean ratios (U.K. ZOFRAN tablet over-encapsulated/U.K. ZOFRAN tablet) of the area under the plasma concentration vs. time curve (AUC) from zero to infinity and maximum plasma concentration (Cmax) for ondansetron each lie within the interval 0.80 to 1.25.|Geometric Mean Ratio|0.904|||||TWO_SIDED|95.0|0.796|1.028|||||Geometric Mean Ratio (Treatment OE U.K. tablet / Treatment U.K. tablet)|Treatment OE U.K. tablet: an over-encapsulated single 8-mg tablet of United Kingdom (U.K.) ZOFRAN (ondansetron) taken orally Treatment U.K. tablet: a single 8-mg tablet of ZOFRAN (ondansetron) which is marketed in the United Kingdom (U.K.) taken orally||1.028|0.796|
72521149|NCT00971633|144570720|NON_INFERIORITY_OR_EQUIVALENCE|Study Primary Hypothesis: A single dose of the U.K. ZOFRAN (ondansetron) 8-mg tablet over-encapsulated is bioequivalent to a single dose of the U.S. ZOFRAN (ondansetron) 8-mg tablet. That is, the true geometric mean rations (U.K. ZOFRAN tablet over-encapsulated/U.S. ZOFRAN tablet) of the area under the plasma concentration vs. time curve (AUC) from zero to infinity and maximum plasma concentration (Cmax) for ondansetron each lie within the interval 0.80 to 1.25.|Geometric Mean Ratio|0.991|||||TWO_SIDED|95.0|0.873|1.126|||||Geometric Mean Ratio (Treatment OE U.K. tablet / Treatment U.S. tablet)|Treatment OE U.K. tablet: an over-encapsulated single 8-mg tablet of United Kingdom (U.K.) ZOFRAN (ondansetron) taken orally Treatment U.S. tablet: a single 8-mg tablet of ZOFRAN (ondansetron) which is marketed in the United States (U.S.) taken orally||1.126|0.873|
72521150|NCT00971633|144570721|NON_INFERIORITY_OR_EQUIVALENCE|Study Secondary Hypothesis: A single dose of U.K. ZOFRAN (ondansetron) 8-mg table over-encapsulated is bioequivalent to a single dose of the U.K. ZOFRAN (ondansetron) 8-mg tablet. That is, the true geometric mean ratios (U.K.) ZOFRAN tablet over-encapsulated/U.K. ZOFRAN tablet) of the area under the plasma concentration vs. time curve (AUC) from zero to infinity and maximum plasma concentration (Cmax) for ondansetron each lie within the interval 0.80 to 1.25.|Geometric Mean Ratio|0.886|||||TWO_SIDED|95.0|0.813|0.966|||||Geometric Mean Ratio (Treatment OE U.K. tablet / Treatment U.K. tablet)|Treatment OE U.K. tablet: an over-encapsulated single 8-mg tablet of United Kingdom (U.K.) ZOFRAN (ondansetron) taken orally Treatment U.K. tablet: a single 8-mg tablet of ZOFRAN (ondansetron) which is marketed in the United Kingdom (U.K.) taken orally||0.966|0.813|
72569853|NCT02944383|144670017|SUPERIORITY||Odds Ratio (OR)|2.57||||0.0865|TWO_SIDED|95.0|0.87|7.53||Logistic regression results are obtained using a model with randomized treatment group, randomized baseline statin (yes or no), and baseline TG value as independent factors.|Regression, Logistic|||Week 12||7.53|0.87|0.0865
72405892|NCT02434770|144320282|NON_INFERIORITY|Secondary efficacy objective 2 of this study was to demonstrate the non-inferiority of the two lots of BBIBP bOPV combined to the WHO control in terms of post-vaccination anti-polio neutralizing antibody GMTs. The two Lots combined would be declared non-inferior to the WHO control if the lower limit of the 95% CI for the serotype-specific GMT ratio of BBIBP Lots 1+2 over WHO control for both serotypes was \> 0.5.|Ratio of Geometric Mean Titers|1.08|||||TWO_SIDED|95.0|0.87|1.34|||||Lot 1 + Lot 2 / BioFarma bOPV|||1.34|0.87|
72405893|NCT02434770|144320283|EQUIVALENCE|Primary efficacy objective 1 of this study was to demonstrate the equivalence of two lots of BBIBP bOPV in terms of post-vaccination anti-polio neutralizing antibody GMTs. The immune response of the two lots of BBIBP bOPV would be declared equivalent if the 95% confidence interval (CI) for the serotype-specific GMT ratio for both serotypes was contained within (0.5, 2.0).|Ratio of Geometric Mean Titers|0.92|||||TWO_SIDED|95.0|0.73|1.15|||||Lot 1 / Lot 2|||1.15|0.73|
72405894|NCT02434770|144320283|NON_INFERIORITY|Secondary efficacy objective 2 of this study was to demonstrate the non-inferiority of the two lots of BBIBP bOPV combined to the WHO control in terms of post-vaccination anti-polio neutralizing antibody GMTs. The two Lots combined would be declared non-inferior to the WHO control if the lower limit of the 95% CI for the serotype-specific GMT ratio of BBIBP Lots 1+2 over WHO control for both serotypes was \> 0.5.|Ratio of Geometric Mean Titers|1.47|||||TWO_SIDED|95.0|1.21|1.79|||||BBIBP bOPV Lot 1 + Lot 2 / BioFarma bOPV|||1.79|1.21|
72405895|NCT02434770|144320284|NON_INFERIORITY|Primary efficacy objective 2 of this study was to demonstrate the non-inferiority of the two lots of BBIBP bOPV combined to the WHO control in terms of post-vaccination anti-polio neutralizing antibody seroconversion rates. The immune response of the combined lots of BBIBP bOPV would be declared non-inferior to the WHO control if the lower limit of the 95% CI for the difference in percent responders is greater than negative 10, provided the two lots are declared equivalent.|Difference in seroconversion rate|1.5|||||TWO_SIDED|95.0|-0.5|4.6|||||BBIBP bOPV (Lot 1 + Lot 2) - BioFarma bOPV|For serotype 1||4.6|-0.5|
72405896|NCT02434770|144320284|NON_INFERIORITY|Primary efficacy objective 2 of this study was to demonstrate the non-inferiority of the two lots of BBIBP bOPV combined to the WHO control in terms of post-vaccination anti-polio neutralizing antibody seroconversion rates. The immune response of the combined lots of BBIBP bOPV would be declared non-inferior to the WHO control if the lower limit of the 95% CI for the difference in percent responders is greater than negative 10, provided the two lots are declared equivalent.|Difference in seroconversion rate|2.2|||||TWO_SIDED|95.0|-0.1|5.6|||||BBIBP bOPV (Lot 1 + Lot 2) - BioFarma bOPV|For Serotype 3||5.6|-0.1|
72521151|NCT00971633|144570721|NON_INFERIORITY_OR_EQUIVALENCE|§ Study Primary Hypothesis: A single dose of the U.K. ZOFRAN (ondansetron) 8-mg tablet over-encapsulated is bioequivalent to a single dose of the U.S. ZOFRAN (ondansetron) 8-mg tablet. That is, the true geometric mean rations (U.K. ZOFRAN tablet over-encapsulated/U.S. ZOFRAN tablet) of the area under the plasma concentration vs. time curve (AUC) from zero to infinity and maximum plasma concentration (Cmax) for ondansetron each lie within the interval 0.80 to 1.25.|Geometric Mean Ratio|0.951|||||TWO_SIDED|95.0|0.872|1.037|||||Geometric Mean Ratio (Treatment OE U.K. tablet / Treatment U.S. tablet)|Treatment OE U.K. tablet: an over-encapsulated single 8-mg tablet of United Kingdom (U.K.) ZOFRAN (ondansetron) taken orally. Treatment U.S. tablet: a single 8-mg tablet of ZOFRAN (ondansetron) which is marketed in the United States (U.S.) taken orally||1.037|0.872|
72521152|NCT01455415|144570727|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.2||||0.3287|TWO_SIDED|95.0|0.83|1.73||Secondary analysis was two-sided and performed at the 0.05 significance level, without multiple comparisons' adjustment.|Regression, Logistic|||Analysis was done using a logistic regression model which included baseline pain, sequence, period and treatment as covariate.||1.73|0.83|0.3287
72624981|NCT02757768|144779458|SUPERIORITY||LS Mean of Difference|0.0|STANDARD_ERROR_OF_MEAN|0.1||0.598|TWO_SIDED|95.0|-0.2|0.1|||ANCOVA|||Week 8 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||0.1|-0.2|0.598
72405897|NCT02434770|144320284|OTHER|Secondary efficacy objective 1 of this study was to show consistency of the two lots in terms of post-vaccination anti-polio neutralizing antibody seroconversion rates. The two lots would be declared consistent if the upper and lower limits of the 95% CI for the difference in seroconversion rates is within 10 percentage points of the observed difference for both serotypes.|Difference in seroconversion rate|-0.4|||||TWO_SIDED|95.0|-3.0|2.1|||||Lot 1 - Lot 2|For Serotype 1||2.1|-3.0|
72405898|NCT02434770|144320284|NON_INFERIORITY|Secondary efficacy objective 1 of this study was to show consistency of the two lots in terms of post-vaccination anti-polio neutralizing antibody seroconversion rates. The two lots would be declared consistent if the upper and lower limits of the 95% CI for the difference in seroconversion rates is within 10 percentage points of the observed difference for both serotypes.|Difference in seroconversion rate|0.1|||||TWO_SIDED|95.0|-2.6|2.8|||||Lot 1 - Lot 2|For Serotype 3||2.8|-2.6|
72405899|NCT02434770|144320285|NON_INFERIORITY|To show non-inferiority of Lots 1+2 combined versus BioFarma bOPV Control, the lower limit of the 95% CI must be \> 0.5.|Ratio of Geometric Mean Titers|1.2|||||TWO_SIDED|95.0|0.89|1.63|||||Lot 1 + Lot 2 / BioFarma bOPV|||1.63|0.89|
72405900|NCT02434770|144320286|OTHER||Difference in seroprotection rate|-0.09||||0.5586|TWO_SIDED|95.0|-3.86|4.48|||Fisher's exact 1-tailed test|Fisher's exact 1-tailed test of a lower rate in Lots 1+2|BBIBP bOPV (Lot 1 + Lot 2) - BioFarma bOPV|||4.48|-3.86|0.5586
72405901|NCT02434770|144320287|NON_INFERIORITY|To show non-inferiority of Lots 1+2 combined versus BioFarma bOPV Control, the lower limit of the 95% CI must be \> 0.5.|Ratio of Geometric Mean Titers|0.99|||||TWO_SIDED|95.0|0.71|1.38|||||Lot 1 + Lot 2 / BioFarma bOPV|||1.38|0.71|
72405902|NCT00245765|144320288|SUPERIORITY||Odds Ratio (OR)|40.2|||<|0.001|TWO_SIDED|95.0|13.7|150.3|||Regression, Logistic|Logistic regression with treatment and baseline severity of psoriasis as factors.|Confidence limits are based on likelihood ratio statistics.|||150.3|13.7|<0.001
72405903|NCT00245765|144320288|SUPERIORITY||Odds Ratio (OR)|73.4|||<|0.001|TWO_SIDED|95.0|23.5|292.6|||Regression, Logistic|Logistic regression with treatment and baseline severity of psoriasis as factors.|Confidence limits are based on likelihood ratio statistics.|||292.6|23.5|<0.001
72521153|NCT01455415|144570728|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.57||||0.0625|TWO_SIDED|95.0|0.98|2.51||Secondary analysis was two-sided and performed at the 0.05 significance level, without multiple comparisons' adjustment.|Regression, Logistic|||Analysis was done using a logistic regression model which included baseline pain, sequence, period and treatment as covariate.||2.51|0.98|0.0625
72569854|NCT02944383|144670017|SUPERIORITY||Odds Ratio (OR)|1.57||||0.399|TWO_SIDED|95.0|0.55|4.48||Logistic regression results are obtained using a model with randomized treatment group, randomized baseline statin (yes or no), and baseline TG value as independent factors.|Regression, Logistic||The OR is an estimate of the odds of achieving a TG value \< 500 mg/dL associated with the corresponding Gemcabene group relative to the placebo group at a given visit.|Week 12||4.48|0.55|0.3990
72521154|NCT01455415|144570729|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.11||0.9448|TWO_SIDED|95.0|-0.21|0.22||Secondary analysis was two-sided and performed at the 0.05 significance level, without multiple comparisons' adjustment.|Mixed Models Analysis|||Analysis was done using a linear mixed effects model which included baseline pain severity, sequence, period, and treatment as fixed effect factors and participant within sequence and within-participant error as random factors. The treatment difference (pregabalin - placebo) has been tested using within-participant variability as error term.||0.22|-0.21|0.9448
72569855|NCT02944383|144670017|SUPERIORITY||Odds Ratio (OR)|2.75||||0.0772|TWO_SIDED|95.0|0.9|8.42||Logistic regression results are obtained using a model with randomized treatment group, randomized baseline statin (yes or no), and baseline TG value as independent factors.|Regression, Logistic||The OR is an estimate of the odds of achieving a TG value \< 500 mg/dL associated with the corresponding Gemcabene group relative to the placebo group at a given visit.|EOS (average of week 10 and 12)||8.42|0.90|0.0772
72569856|NCT02944383|144670017|SUPERIORITY||Odds Ratio (OR)|1.54||||0.4315|TWO_SIDED|95.0|0.53|4.48||Logistic regression results are obtained using a model with randomized treatment group, randomized baseline statin (yes or no), and baseline TG value as independent factors.|Regression, Logistic||The OR is an estimate of the odds of achieving a TG value \< 500 mg/dL associated with the corresponding Gemcabene group relative to the placebo group at a given visit.|EOS (average of week 10 and 12)||4.48|0.53|0.4315
72569857|NCT00364949|144670018|SUPERIORITY_OR_OTHER|||||||0.049||95.0|||||t-test, 2 sided|||||||0.049
72569858|NCT00364949|144670019|SUPERIORITY_OR_OTHER|||||||0.042||95.0|||||t-test, 2 sided|||||||0.042
72569859|NCT00364949|144670020|SUPERIORITY_OR_OTHER|||||||0.156||95.0|||||t-test, 2 sided|||||||0.156
72569860|NCT00364949|144670021|SUPERIORITY_OR_OTHER|||||||0.77||95.0|||||t-test, 2 sided|||||||0.770
72569861|NCT00364949|144670022|SUPERIORITY_OR_OTHER|||||||0.325||95.0|||||t-test, 2 sided|||||||0.325
72569862|NCT04763564|144670029|SUPERIORITY||||||<|0.03||||||A priori threshold for significance was \< 0.05. Significance level liraglutide vs. placebo in percent reduction of bowel frequency at week 4 vs. baseline.|Mixed Models Analysis|||The 2 treatment modalities, Liraglutide and Placebo, were compared. A repeated-measures mixed model was fitted to the data, with treatment (liraglutide or placebo), period, and treatment sequence as fixed effects and the repeated measures within the subject as a random effect.||||<0.03
72569863|NCT04763564|144670032|SUPERIORITY|||||||0.01|||||||Mixed Models Analysis|||The 2 treatment modalities, Liraglutide and Placebo, were compared. A repeated-measures mixed model was fitted to the data, with treatment (liraglutide or placebo), period, and treatment sequence as fixed effects and the repeated measures within the subject as a random effect.||||0.01
72624982|NCT02757768|144779458|SUPERIORITY||LS Mean of Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.1||0.312|TWO_SIDED|95.0|-0.3|0.1|||ANCOVA|||Week 12 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||0.1|-0.3|0.312
72624983|NCT02757768|144779458|SUPERIORITY||LS Mean of Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.1||0.525|TWO_SIDED|95.0|-0.2|0.1|||ANCOVA|||EoT Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||0.1|-0.2|0.525
72521155|NCT01455415|144570730|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.09|STANDARD_ERROR_OF_MEAN|0.12||0.4548|TWO_SIDED|95.0|-0.32|0.14||Secondary analysis was two-sided and performed at the 0.05 significance level, without multiple comparisons' adjustment.|Mixed Models Analysis|||Analysis was done using a linear mixed effects model which included baseline interference score, sequence, period, and treatment as fixed effect factors and participant within sequence and within-participant error as random factors. The treatment difference (pregabalin - placebo) has been tested using within-participant variability as error term.||0.14|-0.32|0.4548
72569864|NCT00852969|144670107|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.69||||0.71|TWO_SIDED|95.0|-10.79|7.41|||t-test, 2 sided|||||7.41|-10.79|0.71
72569865|NCT00852969|144670108|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.48||||0.29|TWO_SIDED|95.0|-7.2|2.24|||t-test, 2 sided|||||2.24|-7.20|0.29
72569866|NCT02440022|144670119|SUPERIORITY|||||||0.0562|||||||Kaplan-Meier|||||||0.0562
72569867|NCT02440022|144670120|NON_INFERIORITY|Where δ = 10% is the non-inferiority margin, which is the range of difference that is considered not clinically important. A non-inferiority Farrington and Manning Test was used to test the primary safety hypothesis. The test is successful if the one-sided p-value is less than 0.025. In addition to the p-value of the test, the confidence intervals of the rate in each group and the difference between the two groups is calculated.||||||0.002|||||||Binary Analysis|||"H0: The primary safety rate p1 in the DCB treatment group through 30 days post index procedure is inferior to that p2 of the PTA treatment group. (i.e. p1 ≤ p2 - δ)~H1: The primary safety rate p1 in the DCB treatment group through 30 days post index procedure is non-inferior to that p2 of the PTA treatment group. (i.e. p1 \> p2 - δ)"||||0.002
72569868|NCT02440022|144670126|OTHER|||||||0.716||||||P-value was type 3 test of the interaction of treatment group and pre-dilation balloon type.|Regression, Cox|||||||0.7160
72569869|NCT02504671|144670129|OTHER||Odds Ratio (OR)|2.12||||0.547|TWO_SIDED|95.0|0.18|24.52|||Regression, Logistic||95% Confidence Intervals (CI) were constructed using asymptotic Wald confidence limits without correction.|||24.52|0.18|0.547
72569870|NCT02504671|144670129|OTHER||Odds Ratio (OR)|7.11||||0.077|TWO_SIDED|95.0|0.81|62.44|||Regression, Logistic||95% CI were constructed using asymptotic Wald confidence limits without correction.|||62.44|0.81|0.077
72569871|NCT02504671|144670129|OTHER||Odds Ratio (OR)|8.39||||0.053|TWO_SIDED|95.0|0.98|72.14|||Regression, Logistic||95% CI were constructed using asymptotic Wald confidence limits without correction.|||72.14|0.98|0.053
72569872|NCT02504671|144670129|OTHER||Odds Ratio (OR)|5.69||||0.122|TWO_SIDED|95.0|0.63|51.4|||Regression, Logistic||95% CI were constructed using asymptotic Wald confidence limits without correction.|||51.40|0.63|0.122
72405904|NCT00245765|144320289|SUPERIORITY||Odds Ratio (OR)|64.1|||<|0.001|TWO_SIDED|95.0|12.7|1169.1|||Regression, Logistic|Logistic regression with treatment and baseline severity of psoriasis as factors. Confidence limits are based on likelihood ratio statistics.||||1169.1|12.7|<0.001
72405905|NCT00245765|144320289|SUPERIORITY||Odds Ratio (OR)|162.6|||<|0.001|TWO_SIDED|95.0|31.4|2999.2|||Regression, Logistic|Logistic regression with treatment and baseline severity of psoriasis as factors.|Confidence limits are based on likelihood ratio statistics.|||2999.2|31.4|<0.001
72405906|NCT01966926|144320304|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Power not calculated due to small sample size and pilot study intent.|chi square|2.05||||0.15|TWO_SIDED|||||P-value was unadjusted, with an a priori threshold for statistical significance set at p \<.05.|Chi-squared|1 degree of freedom||||||.15
72405907|NCT01966926|144320305|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Power not calculated due to small sample size and pilot study intent.|Wilks' Lambda|0.96||||0.61||||||P-value not adjusted for multiple comparisons; a priori threshold of \<0.05 for statistical significance|MANOVA|Degrees of freedom: 2,27||Repeated measures analysis from baseline to six months.||||0.61
72405908|NCT01966926|144320306|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Power not calculated due to small sample size and pilot study intent.|Wilks' Lambda|0.95||||0.5||||||P-value is unadjusted; a priori threshold for statistical significance was \<0.05.|MANOVA|Degrees of freedom: 2,27||Repeated measures analysis from baseline to six months.||||0.50
72521156|NCT01455415|144570731|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.24|STANDARD_ERROR_OF_MEAN|0.11||0.0272|TWO_SIDED|95.0|-0.44|-0.03||Secondary analysis was two-sided and performed at the 0.05 significance level, without multiple comparisons' adjustment.|Mixed Models Analysis|||Analysis was done using linear mixed effects model including baseline score, sequence, period, and treatment as fixed effect factors and participant within sequence and within-participant error as random factors.||-0.03|-0.44|0.0272
72521157|NCT01455415|144570732|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.06|STANDARD_ERROR_OF_MEAN|0.18||0.7344|TWO_SIDED|95.0|-0.42|0.3||Secondary analysis was two-sided and performed at the 0.05 significance level, without multiple comparisons' adjustment.|Mixed Models Analysis|||Analysis was done using a linear mixed effects model which included baseline HADS-A score, sequence, period, and treatment as fixed effect factors and participant within sequence and within-participant error as random factors. The treatment difference (pregabalin - placebo) has been tested using within-participant variability as error term.||0.30|-0.42|0.7344
72569873|NCT02504671|144670129|OTHER||Odds Ratio (OR)|5.4||||0.134|TWO_SIDED|95.0|0.6|48.83|||Regression, Logistic||95% CI were constructed using asymptotic Wald confidence limits without correction.|||48.83|0.60|0.134
72569874|NCT02504671|144670130|OTHER||Mean Difference (Net)|0.46||||0.905|TWO_SIDED|95.0|-7.13|8.05||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|Mixed Model Repeated Measures (MMRM)||CRP, Week 12|||8.05|-7.13|0.905
72624984|NCT02757768|144779460|SUPERIORITY||LS Mean of Difference|0.13|STANDARD_ERROR_OF_MEAN|0.11||0.226|TWO_SIDED|95.0|-0.08|0.34|||ANCOVA|||Week 4 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||0.34|-0.08|0.226
72405909|NCT01966926|144320307|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Power not calculated due to small sample size and pilot study intent.|Wilks' Lambda|0.87||||0.15||||||P-value not adjusted for multiple comparisons; a priori threshold for statistical significance was \<0.05.|MANOVA|Degrees of freedom: 2,27||Repeated measures analysis from baseline to six months.||||0.15
72405910|NCT01966926|144320308|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Power not calculated due to small sample size and pilot study intent.|Wilks' Lambda|0.91||||0.3||||||P-value not adjusted for multiple comparisons; a priori threshold for statistical significance was \<0.05.|MANOVA|Degrees of freedom: 2,26||Repeated measures analysis from baseline to six months.||||0.30
72405911|NCT01966926|144320309|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Power not calculated due to small sample size and pilot study intent.|Wilks' Lambda|0.93||||0.17||||||P-value not adjusted for multiple comparisons; a priori threshold for statistical significance was \<0.05.|MANOVA|Degrees of freedom: 1,28||Repeated measures analysis from three to six months.||||0.17
72405912|NCT04074317|144320310|EQUIVALENCE|Treatment groups were compared using an analysis of variance (ANOVA) model, including sequence, period, and treatment as fixed effects and patient within sequence as random effect.|||||<|0.0001||||||Least-squares geometric means for ln-transformed data.|ANOVA|||||||<0.0001
72405913|NCT04074317|144320310|EQUIVALENCE|Treatment groups were compared using an analysis of variance (ANOVA) model, including sequence, period, and treatment as fixed effects and patient within sequence as random effect.||||||0.694|||||||ANOVA|||||||0.694
72405914|NCT04074317|144320310|EQUIVALENCE|Treatment groups were compared using an analysis of variance (ANOVA) model, including sequence, period, and treatment as fixed effects and patient within sequence as random effect.|||||<|0.0001|||||||ANOVA|||||||<0.0001
72405915|NCT04074317|144320311|EQUIVALENCE|H0: Means are equal between treatment groups. Ha: Means are not equal across the treatment groups.|LS Mean Difference|-21.29||||0.041|TWO_SIDED|95.0|-41.23|-1.36|||ANOVA|||Plasma Glucose Levels: \>180 mg/dL: 0 to 90 minutes||-1.36|-41.23|0.041
72405916|NCT04074317|144320311|EQUIVALENCE|H0: Means are equal between treatment groups. Ha: Means are not equal across the treatment groups.|LS Mean Difference|-7.45||||0.453|TWO_SIDED|95.0|-31.43|16.54|||ANOVA|||Plasma Glucose Levels: \>180 mg/dL: 0 to 90 minutes||16.54|-31.43|0.453
72405917|NCT04074317|144320311|EQUIVALENCE|H0: Means are equal between treatment groups. Ha: means are not equal across the treatment groups.|LS Mean Difference|13.85||||0.161|TWO_SIDED|95.0|-8.46|36.15|||ANOVA|||Plasma Glucose Levels: \>180 mg/dL: 0 to 90 minutes||36.15|-8.46|0.161
72405918|NCT04074317|144320311|EQUIVALENCE|H0: Means are equal between treatment groups. Ha: means are not equal across the treatment groups.|LS Mean Difference|-23.93|||<|0.001|TWO_SIDED|95.0|-35.37|-12.48|||ANOVA|||Plasma Glucose \>180 mg/dL: 0 to 180 minutes||-12.48|-35.37|<0.001
72405919|NCT04074317|144320311|EQUIVALENCE|H0: Means are equal between treatment groups. Ha: means are not equal across the treatment groups.|LS Mean Difference|3.1||||0.564|TWO_SIDED|95.0|-7.8|14.0|||ANOVA|||Plasma Glucose \>180 mg/dL: 0 to 180 minutes||14.00|-7.80|0.564
72569875|NCT02504671|144670130|OTHER||Mean Difference (Net)|-3.36||||0.387|TWO_SIDED|95.0|-11.0|4.28||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||CRP, Week 12|||4.28|-11.00|0.387
72405920|NCT04074317|144320311|EQUIVALENCE|H0: Means are equal between treatment groups. Ha: means are not equal across the treatment groups.|LS Mean Difference|27.03|||<|0.001|TWO_SIDED|95.0|15.96|38.09|||ANOVA|||Plasma Glucose \>180 mg/dL: 0 to 180 minutes||38.09|15.96|<0.001
72405921|NCT04074317|144320311|EQUIVALENCE|H0: Means are equal between treatment groups. Ha: means are not equal across the treatment groups.|LS Mean Difference|-1.74||||0.813|TWO_SIDED|95.0|-16.7|13.22|||ANOVA|||Plasma Glucose \>180 mg/dL: 0 to 360 minutes||13.22|-16.70|0.813
72521158|NCT01455415|144570733|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.09|STANDARD_ERROR_OF_MEAN|0.17||0.6007|TWO_SIDED|95.0|-0.42|0.24||Secondary analysis was two-sided and performed at the 0.05 significance level, without multiple comparisons' adjustment.|Mixed Models Analysis|||Analysis was done using a linear mixed effects model which included baseline HADS-D score, sequence, period, and treatment as fixed effect factors and participant within sequence and within-participant error as random factors. The treatment difference (pregabalin - placebo) has been tested using within-participant variability as error term.||0.24|-0.42|0.6007
72521159|NCT01455415|144570734|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.08|STANDARD_ERROR_OF_MEAN|1.04||0.2987|TWO_SIDED|95.0|-3.13|0.96||Secondary analysis was two-sided and performed at the 0.05 significance level, without multiple comparisons' adjustment.|Mixed Models Analysis|||Analysis was done using a linear mixed effects model which included baseline total score, sequence, period, and treatment as fixed effect factors and participant within sequence and within-participant error as random factors. The treatment difference (pregabalin - placebo) has been tested using within-participant variability as error term.||0.96|-3.13|0.2987
72521160|NCT01455415|144570735|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.35|STANDARD_ERROR_OF_MEAN|0.26||0.1769|TWO_SIDED|95.0|-0.85|0.16||Secondary analysis was two-sided and performed at the 0.05 significance level, without multiple comparisons' adjustment.|Mixed Models Analysis|||Analysis was done using a linear mixed effects model which included baseline symptoms domain score, sequence, period, and treatment as fixed effect factors and participant within sequence and within-participant error as random factors. The treatment difference (pregabalin - placebo) has been tested using within-participant variability as error term.||0.16|-0.85|0.1769
72521161|NCT01455415|144570736|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.12|STANDARD_ERROR_OF_MEAN|0.18||0.5119|TWO_SIDED|95.0|-0.48|0.24||Secondary analysis was two-sided and performed at the 0.05 significance level, without multiple comparisons' adjustment.|Mixed Models Analysis|||Analysis was done using a linear mixed effects model which included baseline activities of daily living domain score, sequence, period, and treatment as fixed effect factors and participant within sequence and within-participant error as random factors. The treatment difference (pregabalin - placebo) has been tested using within-participant variability as error term.||0.24|-0.48|0.5119
72521162|NCT01455415|144570737|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.49|STANDARD_ERROR_OF_MEAN|0.62||0.4335|TWO_SIDED|95.0|-1.72|0.74||Secondary analysis was two-sided and performed at the 0.05 significance level, without multiple comparisons' adjustment.|Mixed Models Analysis|||Analysis was done using a linear mixed effects model which included baseline physical functioning / large fiber domain score, sequence, period, and treatment as fixed effect factors and participant within sequence and within-participant error as random factors. The treatment difference (pregabalin - placebo) has been tested using within-participant variability as error term.||0.74|-1.72|0.4335
72521163|NCT01455415|144570738|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.16||0.9653|TWO_SIDED|95.0|-0.31|0.3||Secondary analysis was two-sided and performed at the 0.05 significance level, without multiple comparisons' adjustment.|Mixed Models Analysis|||Analysis was done using a linear mixed effects model which included baseline small fiber domain score, sequence, period, and treatment as fixed effect factors and participant within sequence and within-participant error as random factors. The treatment difference (pregabalin - placebo) has been tested using within-participant variability as error term.||0.30|-0.31|0.9653
72521164|NCT01455415|144570739|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.14|STANDARD_ERROR_OF_MEAN|0.12||0.269|TWO_SIDED|95.0|-0.38|0.11||Secondary analysis was two-sided and performed at the 0.05 significance level, without multiple comparisons' adjustment.|Mixed Models Analysis|||Analysis was done using a linear mixed effects model which included baseline autonomic domain score, sequence, period, and treatment as fixed effect factors and participant within sequence and within-participant error as random factors. The treatment difference (pregabalin - placebo) has been tested using within-participant variability as error term.||0.11|-0.38|0.2690
72521165|NCT01455415|144570740|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.03||0.9951|TWO_SIDED|95.0|-0.05|0.05||Secondary analysis was two-sided and performed at the 0.05 significance level, without multiple comparisons' adjustment.|Mixed Models Analysis|||Analysis was done using a linear mixed effects model which included baseline mobility domain score, sequence, period, and treatment as fixed effect factors and participant within sequence and within-participant error as random factors. The treatment difference (pregabalin - placebo) has been tested using within-participant variability as error term.||0.05|-0.05|0.9951
72405922|NCT04074317|144320311|EQUIVALENCE|H0: Means are equal between treatment groups. Ha: means are not equal across the treatment groups.|LS Mean Difference|2.35||||0.73|TWO_SIDED|95.0|-11.47|16.17|||ANOVA|||Plasma Glucose \>180 mg/dL: 0 to 360 minutes||16.17|-11.47|0.730
72405923|NCT04074317|144320311|EQUIVALENCE|H0: Means are equal between treatment groups. Ha: means are not equal across the treatment groups.|LS Mean Difference|4.09||||0.582|TWO_SIDED|95.0|-10.97|19.15|||ANOVA|||Plasma Glucose \>180 mg/dL: 0 to 360 minutes||19.15|-10.97|0.582
72405924|NCT04074317|144320317|EQUIVALENCE|"Bioequivalence would require 90% confidence intervals of the geometric mean ratio to be contained within the 80-125% range.~H0: Means are equal between treatment groups. Ha: Means are not equal across the treatment groups."|Ratio of geometric least-squares means|37.04|||<|0.0001|TWO_SIDED|90.0|31.36|43.75||Results of the statistical evaluation of ANOVA (alpha=0.05) for the hypothesis of equal treatment effects.|ANOVA||"Ratio calculated as PRAM geometric least-squares mean divided by the Regular Insulin + Pramlintide geometric least-squares mean, expressed as a percentage.~Confidence interval on the ratio, expressed as a percentage."|The statistical model was an analysis of variance (ANOVA) on the ln-transformed data with sequence, period, and treatment as fixed effect and subject nested within sequence as a random effect.||43.75|31.36|<0.0001
72405925|NCT04074317|144320318|OTHER||Ratio of least-square means|435.96|||<|0.0001|TWO_SIDED|||||Results of the statistical evaluation of ANOVA (alpha = 0.05) for the hypothesis of equal treatment effects.|ANOVA||Ratio calculated as PRAM least-squares mean divided by the Regular Insulin + Pramlintide least-squares mean, expressed as a percentage.|The statistical model was an analysis of variance (ANOVA) with sequence, period, and treatment as fixed effect and subject nested within sequence as a random effect.||||<0.0001
72405926|NCT04074317|144320319|EQUIVALENCE|"Bioequivalence would require the 90% confidence intervals of the geometric mean ratio to be contained within the 80 - 125% range.~H0: Means are equal between treatment groups. Ha: Means are not equal across the treatment groups."|Ratio of geometric least-squares means|60.44||||0.0075|TWO_SIDED|90.0|45.41|80.43||Results of the statistical evaluation of ANOVA (alpha=0.05) for the hypothesis of equal treatment effects.|ANOVA||"Ratio calculated as PRAM geometric least-squares mean divided by the Regular Insulin + Pramlintide geometric least-squares mean, expressed as a percentage.~Confidence interval on the ratio, expressed as a percentage."|AUC 0 to 90 The statistical model was an analysis of variance (ANOVA) on the ln-transformed data with sequence, period, and treatment as fixed effect and subject nested within sequence as a random effect.||80.43|45.41|0.0075
72521166|NCT01455415|144570741|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.02||0.9726|TWO_SIDED|95.0|-0.05|0.05||Secondary analysis was two-sided and performed at the 0.05 significance level, without multiple comparisons' adjustment.|Mixed Models Analysis|||Analysis was done using a linear mixed effects model which included baseline self-care domain score, sequence, period, and treatment as fixed effect factors and participant within sequence and within-participant error as random factors. The treatment difference (pregabalin - placebo) has been tested using within-participant variability as error term.||0.05|-0.05|0.9726
72521167|NCT01455415|144570742|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.03||0.5497|TWO_SIDED|95.0|-0.04|0.08||Secondary analysis was two-sided and performed at the 0.05 significance level, without multiple comparisons' adjustment.|Mixed Models Analysis|||Analysis was done using a linear mixed effects model which included baseline usual activities domain score, sequence, period, and treatment as fixed effect factors and participant within sequence and within-participant error as random factors. The treatment difference (pregabalin - placebo) has been tested using within-participant variability as error term.||0.08|-0.04|0.5497
72521168|NCT01455415|144570743|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.03||0.1495|TWO_SIDED|95.0|-0.02|0.11||Secondary analysis was two-sided and performed at the 0.05 significance level, without multiple comparisons' adjustment.|Mixed Models Analysis|||Analysis was done using a linear mixed effects model which included baseline pain / discomfort domain score, sequence, period, and treatment as fixed effect factors and participant within sequence and within-participant error as random factors. The treatment difference (pregabalin - placebo) has been tested using within-participant variability as error term.||0.11|-0.02|0.1495
72521169|NCT01455415|144570744|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.03||0.1297|TWO_SIDED|95.0|-0.11|0.01||Secondary analysis was two-sided and performed at the 0.05 significance level, without multiple comparisons' adjustment.|Mixed Models Analysis|||Analysis was done using a linear mixed effects model which included baseline anxiety / depression domain score, sequence, period, and treatment as fixed effect factors and participant within sequence and within-participant error as random factors. The treatment difference (pregabalin - placebo) has been tested using within-participant variability as error term.||0.01|-0.11|0.1297
72521170|NCT01455415|144570745|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.01||0.4279|TWO_SIDED|95.0|-0.04|0.02||Secondary analysis was two-sided and performed at the 0.05 significance level, without multiple comparisons' adjustment.|Mixed Models Analysis|||Analysis was done using a linear mixed effects model which included baseline Dolan 1997 index summary score, sequence, period, and treatment as fixed effect factors and participant within sequence and within-participant error as random factors. The treatment difference (pregabalin - placebo) has been tested using within-participant variability as error term.||0.02|-0.04|0.4279
72521171|NCT01455415|144570746|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.01||0.5505|TWO_SIDED|95.0|-0.04|0.02||Secondary analysis was two-sided and performed at the 0.05 significance level, without multiple comparisons' adjustment.|Mixed Models Analysis|||Analysis was done using a linear mixed effects model which included baseline Dolan 2001 index summary score, sequence, period, and treatment as fixed effect factors and participant within sequence and within-participant error as random factors. The treatment difference (pregabalin - placebo) has been tested using within-participant variability as error term.||0.02|-0.04|0.5505
72521172|NCT01455415|144570747|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0604|TWO_SIDED|||||Secondary analysis was two-sided and performed at the 0.05 significance level, without multiple comparisons' adjustment.|Cochran-Mantel-Haenszel|||Analysis was done using a Cochran-Mantel-Haenszel (CMH) test with modified ridit transformation, under alternative hypothesis of raw mean scores differ.||||0.0604
72521173|NCT01455415|144570748|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.038|STANDARD_ERROR_OF_MEAN|0.106||0.7174|TWO_SIDED|95.0|-0.248|0.171||Primary analysis was two-sided and performed at the 0.05 significance level.|Repeated measure mixed effects model|The Kenward-Roger method was used to estimate denominator degrees of freedom.||A longitudinal analysis was done using a repeated measure linear mixed effects model including visit, treatment, an indicator variable for Week 6, and treatment by visit and by the indicator variable interaction as fixed effect factors and participant within sequence and within-participant error (estimated by using an unstructured covariance structure) as random factors. The treatment differences were tested using within-participant variability as the error term.||0.171|-0.248|0.7174
72521174|NCT01455415|144570749|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1511|TWO_SIDED|||||Secondary analysis was two-sided and performed at the 0.05 significance level, without multiple comparisons' adjustment.|Cochran-Mantel-Haenszel|||Analysis was done using a CMH test with modified ridit transformation, under alternative hypothesis of raw mean scores differ.||||0.1511
72521175|NCT01496274|144570763|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P value is based on a Wilcoxon signed-rank test of H0: AsBR ratio (prophylaxis regimen/on-demand regimen) ≥ 0.50. The ratio was based on the original scale.|Wilcoxon signed-rank test|||A test of null hypothesis that the ratio of AsBR (prophylaxis regimen/on-demand regimen) was ≥ 0.50 was conducted at the 1-sided 0.025 level. Matched pairs design with 19 subjects and 2 observations per subject.||||<0.0001
72521176|NCT01293084|144570810|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|2.2||||0.62|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.62
72521177|NCT01293084|144570811|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|2.3||||0.32|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.32
72521178|NCT02690168|144570835|OTHER|||||||0.0053|||||||t-test, 2 sided|||||||0.0053
72521179|NCT02690168|144570836|OTHER|||||||0.477|||||||t-test, 2 sided|||||||0.477
72521180|NCT02690168|144570837|OTHER|||||||0.917|||||||t-test, 2 sided|||||||0.917
72521181|NCT02690168|144570839|OTHER|||||||0.53|||||||t-test, 2 sided|||||||0.53
72624985|NCT02757768|144779460|SUPERIORITY||LS Mean of Difference|0.07|STANDARD_ERROR_OF_MEAN|0.11||0.501|TWO_SIDED|95.0|-0.14|0.28|||ANCOVA|||Week 8 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||0.28|-0.14|0.501
72624986|NCT02757768|144779460|SUPERIORITY||LS Mean of Difference|0.0|STANDARD_ERROR_OF_MEAN|0.12||0.984|TWO_SIDED|95.0|-0.22|0.23|||ANCOVA|||Week 12 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||0.23|-0.22|0.984
72624987|NCT02757768|144779460|SUPERIORITY||LS Mean of Difference|0.03|STANDARD_ERROR_OF_MEAN|0.11||0.78|TWO_SIDED|95.0|-0.18|0.24|||ANCOVA|||EoT Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||0.24|-0.18|0.780
72624988|NCT02757768|144779461|SUPERIORITY||LS Mean of Difference|3.1|STANDARD_ERROR_OF_MEAN|1.9||0.107|TWO_SIDED|95.0|-0.7|6.8|||ANCOVA|||Week 4 Difference vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||6.8|-0.7|0.107
72624989|NCT02757768|144779461|SUPERIORITY||LS Mean of Difference|2.5|STANDARD_ERROR_OF_MEAN|1.9||0.19|TWO_SIDED|95.0|-1.3|6.3|||ANCOVA|||Week 8 Difference vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||6.3|-1.3|0.190
72624990|NCT02757768|144779461|SUPERIORITY||LS Mean of Difference|2.2|STANDARD_ERROR_OF_MEAN|2.1||0.297|TWO_SIDED|95.0|-1.9|6.3|||ANCOVA|||Week 12 Difference vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||6.3|-1.9|0.297
72521182|NCT01961089|144570854|EQUIVALENCE|The significance of a difference in a measured parameter between two devices was assessed using a paired t-test.||||||0.09|||||||Paired t-test|||P-value comparing AL between G6 and IOLM||||0.09
72521183|NCT01961089|144570854|EQUIVALENCE|The significance of a difference in a measured parameter between two devices was assessed using a paired t-test|||||<|0.001|||||||Paired t-test|||P-value comparing AL between G6 and LS||||<0.001
72521184|NCT01961089|144570854|EQUIVALENCE|The significance of a difference in a measured parameter between two devices was assessed using a paired t-test|||||<|0.0001|||||||Paired t-test|||P-value comparing AL between IOLM and LS||||<0.0001
72521185|NCT01961089|144570854|EQUIVALENCE|The significance of a difference in a measured parameter between two devices was assessed using a paired t-test|||||<|0.0001|||||||Paired t-test|||P-value comparing CCT between G6 and LS||||<0.0001
72521186|NCT01961089|144570854|EQUIVALENCE|The significance of a difference in a measured parameter between two devices was assessed using a paired t-test|||||<|0.0001|||||||Paired t-test|||P-value comparing ACD between G6 and IOLM||||<0.0001
72521187|NCT01961089|144570854|EQUIVALENCE|The significance of a difference in a measured parameter between two devices was assessed using a paired t-test|||||<|0.01|||||||Paired t-test|||P-value comparing ACD between G6 and LS||||<0.01
72521188|NCT01961089|144570854|EQUIVALENCE|The significance of a difference in a measured parameter between two devices was assessed using a paired t-test||||||0.02|||||||Paired t-test|||P-value comparing ACD between IOLM and LS||||0.02
72521189|NCT01961089|144570854|EQUIVALENCE|The significance of a difference in a measured parameter between two devices was assessed using a paired t-test|||||<|0.01|||||||Paired t-test|||P-value comparing LT between G6 and LS||||<0.01
72521190|NCT01961089|144570854|EQUIVALENCE|The significance of a difference in a measured parameter between two devices was assessed using a paired t-test|||||<|0.0001|||||||Paired t-test|||P-value comparing WtW between G6 and IOLM||||<0.0001
72521191|NCT01961089|144570854|EQUIVALENCE|The significance of a difference in a measured parameter between two devices was assessed using a paired t-test|||||<|0.0001|||||||Paired t-test|||P-value comparing WtW between G6 and LS||||<0.0001
72521192|NCT01961089|144570854|EQUIVALENCE|The significance of a difference in a measured parameter between two devices was assessed using a paired t-test|||||<|0.001|||||||Paired t-test|||P-value comparing WtW between IOLM and LS||||<0.001
72521193|NCT01961089|144570855|SUPERIORITY_OR_OTHER_LEGACY|||||||0.05|||||||ANOVA|||Repeatability was determined with random effect ANOVAs (estimates of random effects). They were calculated as the square root of the sum of the (Device x EyeID) interaction component plus (EyeID) and (Device) variance components plus the residual variance component. A (Device x Operator) interaction component was not assessed because each device was consistently operated by the same operator such that there was no Device x Operator interaction component. CV = Coefficient of Variation = SD/mean.||||0.05
72521194|NCT01961089|144570856|EQUIVALENCE|The significance of a difference in a measured parameter between two devices was assessed using a paired t-test||||||0.13|||||||Paired t-test|||P-value comparing SimK between G6 and IOLM||||0.13
72521195|NCT01961089|144570856|EQUIVALENCE|The significance of a difference in a measured parameter between two devices was assessed using a paired t-test||||||0.25|||||||Paired t-test|||P-value comparing SimK between G6 and LS||||0.25
72521196|NCT01961089|144570856|EQUIVALENCE|The significance of a difference in a measured parameter between two devices was assessed using a paired t-test||||||0.21|||||||Paired t-test|||P-value comparing SimK between IOLM and LS||||0.21
72624991|NCT02757768|144779461|SUPERIORITY||LS Mean of Difference|1.4|STANDARD_ERROR_OF_MEAN|2.1||0.493|TWO_SIDED|95.0|-2.7|5.5|||ANCOVA|||EoT Difference vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||5.5|-2.7|0.493
72624992|NCT05395338|144779496|OTHER|cox proportional hazards models with stratification by matching pairs|Hazard Ratio (HR)|0.9||||0.183|TWO_SIDED|95.0|0.78|1.05|||Regression, Cox||rt-PA/non reperfusion|||1.05|0.78|0.183
72624993|NCT05395338|144779497|OTHER|Conditional logistic regression models with stratification by matching pairs.|Odds Ratio (OR)|1.25|||<|0.001|TWO_SIDED|95.0|1.12|1.39|||Regression, Logistic|||||1.39|1.12|<0.001
72405927|NCT04074317|144320319|EQUIVALENCE|"Bioequivalence would require 90% confidence intervals of the geometric mean ratio to be contained within the 80 - 125% range.~H0: Means are equal between treatment groups. Ha: Means are not equal across the treatment groups."|Ratio of geometric least-squares means|93.32||||0.6773|TWO_SIDED|90.0|70.14|124.16||Results of the statistical evaluation of ANOVA (alpha=0.05) for the hypothesis of equal treatment effects.|ANOVA|Based on Least-Squares geometric means for ln-transformed data.|"Ratio calculated as PRAM geometric least-squares mean divided by the Regular Insulin + Pramlintide geometric least-squares mean, expressed as a percentage.~Confidence interval on the ratio, expressed as a percentage."|AUC 0 to 180 The statistical model was an analysis of variance (ANOVA) on the ln-transformed data with sequence, period, and treatment as fixed effect and subject nested within sequence as a random effect.||124.16|70.14|0.6773
72521197|NCT04209400|144570867|NON_INFERIORITY|P \< 0.05 is considered a statistically significant difference in seroconversion between the two groups.||||||1|||||||Chi-squared|||The null hypothesis is that the vaccines equally affect the achievement of seroconversion level.||||1
72521198|NCT01203787|144570902|SUPERIORITY_OR_OTHER|||||||0.0262|TWO_SIDED||||||Wilcoxon rank sum test|||||||0.0262
72521199|NCT02823080|144570917|OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
72521200|NCT02823080|144570918|OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
72521201|NCT02823080|144570919|OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
72521202|NCT02823080|144570923|OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
72521203|NCT00323310|144570934|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.3|STANDARD_DEVIATION|1.46|<|0.0001|TWO_SIDED|95.0|1.1|1.5||H0: udiff = 0; Ha: udiff not = 0|t-test, 2 sided|||Paired t-test to compare change from pre to pre+postdose||1.5|1.1|<0.0001
72521204|NCT00323310|144570935|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.2|STANDARD_DEVIATION|1.45|<|0.0001|TWO_SIDED|95.0|0.9|1.4||H0: udiff = 0; Ha: udiff not = 0|t-test, 2 sided|||Paired t-test to compare change from pre to pre+postdose||1.4|0.9|<0.0001
72521205|NCT00323310|144570936|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.7|STANDARD_DEVIATION|1.42|<|0.0001|TWO_SIDED|95.0|0.4|0.9||H0: udiff = 0; Ha: udiff not = 0|t-test, 2 sided|||Paired t-test to compare change from pre to pre+postdose||0.9|0.4|<0.0001
72521206|NCT00323310|144570937|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.3|STANDARD_DEVIATION|1.56|<|0.001|TWO_SIDED|95.0|1.1|1.6||H0: udiff = 0; Ha: udiff not = 0|t-test, 2 sided|||Paired t-test to compare change from pre to pre+postdose||1.6|1.1|<0.001
72521207|NCT00323310|144570938|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.1|STANDARD_DEVIATION|1.49|<|0.001|TWO_SIDED|95.0|0.8|1.4||H0: udiff = 0; Ha: udiff not = 0|t-test, 2 sided|||Paired t-test to compare change from pre to pre+postdose||1.4|0.8|<0.001
72521208|NCT00323310|144570939|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.6|STANDARD_DEVIATION|1.2|<|0.0001|TWO_SIDED|95.0|0.4|0.8||H0: udiff = 0; Ha: udiff not = 0|t-test, 2 sided|||Paired t-test to compare change from pre to pre+postdose||0.8|0.4|<0.0001
72521209|NCT00323310|144570940|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.2|STANDARD_DEVIATION|1.57|<|0.0001|TWO_SIDED|95.0|1.0|1.5||H0: udiff = 0; Ha: udiff not = 0|t-test, 2 sided|||Paired t-test to compare change from pre to pre+postdose||1.5|1.0|<0.0001
72521210|NCT00323310|144570941|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.2|STANDARD_DEVIATION|1.49|<|0.0001|TWO_SIDED|95.0|0.9|1.4||H0: udiff = 0; Ha: udiff not = 0|t-test, 2 sided|||Paired t-test to compare change from pre to pre+postdose||1.4|0.9|<0.0001
72521211|NCT00323310|144570942|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.8|STANDARD_DEVIATION|1.54|<|0.0001|TWO_SIDED|95.0|0.6|1.1||H0: udiff = 0; Ha: udiff not = 0|t-test, 2 sided|||Paired t-test to compare change from pre to pre+postdose||1.1|0.6|<0.0001
72521212|NCT02707601|144570999|SUPERIORITY|||||||0.002||||||The p-value is obtained from the 2-sided exact 1-sample binomial test for the superiority over the performance goal of 88%.|Binomial test|||||||0.002
72521213|NCT02707601|144570999|SUPERIORITY|||||||0.042||||||The p-value is obtained from the 2-sided exact 1-sample binomial test for the superiority over the performance goal of 88%.|Binomial test|||||||0.042
72521214|NCT02707601|144571000|SUPERIORITY|||||||0.002||||||The p-value is obtained from the 2-sided exact 1-sample binomial test for the superiority over the performance goal of 88%.|Binomial test|||||||0.002
72521215|NCT02707601|144571000|SUPERIORITY|||||||0.002||||||The p-value is obtained from the 2-sided exact 1-sample binomial test for the superiority over the performance goal of 88%.|Binomial test|||||||0.002
72521216|NCT02707601|144571001|OTHER||Difference in Percentages|0.0||||1|TWO_SIDED|95.0|-6.1|6.1|||Fisher exact test||The differences in percentages of participants between treatment groups and their 95% confidence intervals (CIs) were calculated based on an unconditional exact method using 2 inverted 1-sided tests.|||6.1|-6.1|1.00
72521217|NCT01392742|144571031|SUPERIORITY_OR_OTHER|||||||0|TWO_SIDED||||||Regression, Logistic|||Binary logistic regression for RVR at Week 4.||||0.000
72521218|NCT01392742|144571031|SUPERIORITY_OR_OTHER|||||||0.018|TWO_SIDED||||||Regression, Linear|||Binary logistic regression for gender at Week 4.||||0.018
72521219|NCT01392742|144571031|SUPERIORITY_OR_OTHER|||||||0.062|TWO_SIDED||||||Regression, Logistic|||Binary logistic regression for liver fibrosis at Week 4.||||0.062
72521220|NCT01392742|144571031|SUPERIORITY_OR_OTHER|||||||0.05|TWO_SIDED||||||Regression, Logistic|||Binary logistic regression for HCV genotype at Week 4.||||0.050
72521221|NCT01392742|144571031|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED||||||Regression, Logistic|||Binary logistic regression for height at Week 4.||||0.001
72521222|NCT01392742|144571031|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED||||||Regression, Logistic|||Binary logistic regression for treatment duration at Week 4.||||0.001
72405928|NCT04074317|144320319|EQUIVALENCE|"Bioequivalence would require the 90% confidence intervals of the geometric mean ratio to be contained within the 80 - 125% range.~H0: Means are equal between treatment groups. Ha: Means are not equal across the treatment groups."|Ratio of geometric least-squares means|97.43||||0.8768|TWO_SIDED|90.0|72.94|130.14||Results of the statistical evaluation of ANOVA (alpha=0.05) for the hypothesis of equal treatment effects.|ANOVA||"Ratio calculated as PRAM geometric least-squares mean divided by the Regular Insulin + Pramlintide geometric least-squares mean, expressed as a percentage.~Confidence interval on the ratio, expressed as a percentage."|AUC 0 to 360 The statistical model was an analysis of variance (ANOVA) on the ln-transformed data with sequence, period, and treatment as fixed effect and subject nested within sequence as a random effect.||130.14|72.94|0.8768
72405929|NCT04074317|144320320|EQUIVALENCE|"Bioequivalence would require the 90% confidence intervals of the geometric mean ratio to be contained within the 80 - 125% range.~H0: Means are equal between treatment groups. Ha: Means are not equal across the treatment groups."|Ratio of geometric least-squares means|53.83|||<|0.0001|TWO_SIDED|90.0|44.51|65.11||Bonferroni-adjusted p-value to maintain the overall Type 1 error rate at 0.05.|ANOVA||"Ratio calculated as PRAM geometric least-squares mean divided by the Regular Insulin geometric least-squares mean, expressed as a percentage.~Confidence interval on the ratio, expressed as a percentage."|The statistical model was ana analysis of variance (ANOVA) on the ln-transformed data with sequence, period, and treatment as fixed effect and subject nested within sequence as a random effect.||65.11|44.51|<0.0001
72405930|NCT04074317|144320320|EQUIVALENCE|"Bioequivalence would require the 90% confidence intervals of the geometric mean ratio to be contained within the 80 - 125% range.~H0: Means are equal between treatment groups. Ha: Means are not equal across the treatment groups."|Ratio of geometric least-squares means|73.16||||0.0192|TWO_SIDED|90.0|61.06|87.67||Bonferroni-adjusted p-value to maintain the overall Type 1 error rate at 0.05.|ANOVA||"Ratio calculated as PRAM geometric least-squares mean divided by the Regular Insulin + Pramlintide geometric least-squares mean, expressed as a percentage.~Confidence interval on the ratio, expressed as a percentage."|The statistical model was an analysis of variance (ANOVA) on the ln-transformed data with sequence, period, and treatment as fixed effect and subject nested within sequence as a random effect.||87.67|61.06|0.0192
72521223|NCT01392742|144571031|SUPERIORITY_OR_OTHER|||||||0.037|TWO_SIDED||||||Regression, Logistic|||Binary logistic regression for EVR at Week 12.||||0.037
72521224|NCT01392742|144571031|SUPERIORITY_OR_OTHER|||||||0.018|TWO_SIDED||||||Regression, Logistic|||Binary logistic regression for gender at Week 12.||||0.018
72521225|NCT01392742|144571031|SUPERIORITY_OR_OTHER|||||||0.092|TWO_SIDED||||||Regression, Logistic|||Binary logistic regression for liver fibrosis at Week 12.||||0.092
72521226|NCT01392742|144571031|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED||||||Regression, Logistic|||Binary logistic regression for height at Week 12.||||0.001
72521227|NCT01392742|144571031|SUPERIORITY_OR_OTHER|||||||0.042|TWO_SIDED||||||Regression, Logistic|||Binary logistic regression for treatment duration at Week 12.||||0.042
72521228|NCT02911519|144571048|SUPERIORITY||Risk Ratio (RR)|0.95||||0.59|TWO_SIDED|95.0|0.77|1.16|||Mixed Models Analysis||This is intention-to-treat analysis. The Brief Group Psychoeducation is the numerator and the group of Treatment as Usual Only is the denominator for relative risk.|||1.16|0.77|0.59
72521229|NCT02911519|144571049|SUPERIORITY||Risk Ratio (RR)|0.98||||0.73|TWO_SIDED|95.0|0.87|1.1|||Mixed Models Analysis||The Brief Group Psychoeducation is the numerator and the group of Treatment as Usual Only is the denominator for relative risk. This is intention-to-treat analysis.|||1.10|0.87|0.73
72521230|NCT02911519|144571050|SUPERIORITY||Slope|0.01||||0.94|TWO_SIDED|95.0|-0.36|0.39|||Mixed Models Analysis||This is intention-to-treat analysis.|||0.39|-0.36|0.94
72521231|NCT02911519|144571050|SUPERIORITY||Slope|-0.19||||0.3|TWO_SIDED|95.0|-0.57|0.18|||Mixed Models Analysis||This is intention-to-treat analysis.|||0.18|-0.57|0.30
72521232|NCT02911519|144571052|SUPERIORITY||Slope|0.03||||0.61|TWO_SIDED|95.0|-0.1|0.17|||Mixed Models Analysis||This is an intention to treat analysis.|||0.17|-0.10|0.61
72521233|NCT02911519|144571053|SUPERIORITY|This statistical Analysis applies to WHOQOL-BREF 1ST DOMAIN (physical health) in the first row.|Slope|0.04||||0.81|TWO_SIDED|95.0|-0.38|0.3|||Mixed Models Analysis||This is an intention to treat analysis. This statistical Analysis applies to WHOQOL-BREF 1ST DOMAIN (physical health) in the first row.|||0.30|-0.38|0.81
72521234|NCT02911519|144571053|SUPERIORITY|This is an intention to treat analysis. This statistical Analysis applies to WHOQOL-BREF 2ND DOMAIN (psychological) in the second row.|Slope|-0.04||||0.81|TWO_SIDED|95.0|-0.38|0.29|||Mixed Models Analysis||This is an intention to treat analysis.This statistical Analysis applies to WHOQOL-BREF 2ND DOMAIN (psychological) in the second row.|||0.29|-0.38|0.81
72521235|NCT02911519|144571053|SUPERIORITY|This statistical Analysis applies to WHOQOL-BREF 3RD DOMAIN (social relationships) in the third row.|Slope|0.16||||0.52|TWO_SIDED|95.0|-0.33|0.65|||Mixed Models Analysis||This is an intention to treat analysis. This statistical Analysis applies to WHOQOL-BREF 3RD DOMAIN (social relationships) in the third row.|||0.65|-0.33|0.52
72521236|NCT02911519|144571053|SUPERIORITY|This statistical Analysis applies to WHOQOL-BREF 4TH DOMAIN (environment) in the fourth row.|Slope|0.19||||0.27|TWO_SIDED|95.0|-0.15|0.53|||Mixed Models Analysis||This is an intention to treat analysis. This statistical Analysis applies to WHOQOL-BREF 4TH DOMAIN (environment) in the fourth row.|||0.53|-0.15|0.27
72521237|NCT02911519|144571054|SUPERIORITY|This analysis applies to SSFB objective domain in the first row.|Slope|-0.01||||0.33|TWO_SIDED|95.0|-0.01|0.01|||Mixed Models Analysis||This is an intention to treat analysis. This analysis applies to SSFB objective domain in the first row.|||0.01|-0.01|0.33
72521238|NCT02911519|144571054|SUPERIORITY|This is an intention to treat analysis. This analysis applies to SSFB subjective domain in the second row.|Slope|-0.01||||0.19|TWO_SIDED|95.0|-0.02|0.01|||Mixed Models Analysis||This is an intention to treat analysis. This analysis applies to SSFB subjective domain in the second row.|||0.01|-0.02|0.19
72521239|NCT02911519|144571055|SUPERIORITY||Slope|0.01||||0.97|TWO_SIDED|95.0|-0.19|0.19|||Mixed Models Analysis||This is an intention to treat analysis.|||0.19|-0.19|0.97
72521240|NCT01444898|144571069|SUPERIORITY_OR_OTHER|||||||0.07|||||||Mixed Models Analysis|||||||.07
72521241|NCT01444898|144571070|SUPERIORITY_OR_OTHER|||||||0.08|||||||Mixed Models Analysis|||||||0.08
72521242|NCT01444898|144571071|SUPERIORITY_OR_OTHER|||||||0.8|||||||Mixed Models Analysis|||||||.8
72521243|NCT01444898|144571072|SUPERIORITY_OR_OTHER|||||||0.04|||||||Mixed Models Analysis|||||||.04
72521244|NCT01444898|144571073|SUPERIORITY_OR_OTHER|||||||0.8|||||||Mixed Models Analysis|||||||.8
72405931|NCT04074317|144320320|EQUIVALENCE|"Bioequivalence would require the 90% confidence intervals of the geometric mean ratio to be contained within the 80 - 125% range.~H0: Means are equal between treatment groups. Ha: Means are not equal across the treatment groups."|Ratio of geometric least-squares means|135.91||||0.0244|TWO_SIDED|90.0|113.1|163.31||Bonferroni-adjusted p-value to maintain the overall Type 1 error rate at 0.05.|ANOVA||"Ratio calculated as Regular Insulin geometric least-squares mean divided by the Regular Insulin + Pramlintide geometric least-squares mean, expressed as a percentage.~Confidence interval on the ratio, expressed as a percentage."|The statistical model was an analysis of variance (ANOVA) on the ln-transformed data with sequence, period, and treatment as fixed effect and subject nested within sequence as a random effect.||163.31|113.10|0.0244
72405932|NCT04074317|144320321|OTHER||Ratio of least-square means|73.53||||0.2541|TWO_SIDED|||||Bonferroni-adjusted p-value to maintain the overall Type 1 error rate at 0.05|ANOVA||Ratio calculated as PRAM least-squares mean divided by the Regular Insulin least-squares mean, expressed as a percentage.|The statistical model was an analysis of variance (ANOVA) with sequence, period, and treatment as fixed effect and subject nested within sequence as a random effect.||||0.2541
72521245|NCT01444898|144571074|SUPERIORITY_OR_OTHER|||||||0.2|||||||Mixed Models Analysis|||||||.2
72521246|NCT01444898|144571075|SUPERIORITY_OR_OTHER|||||||0.2|||||||Mixed Models Analysis|||||||.2
72521247|NCT01444898|144571076|SUPERIORITY_OR_OTHER|||||||0.04|||||||Mixed Models Analysis|||||||.04
72521248|NCT01444898|144571077|SUPERIORITY_OR_OTHER|||||||0.004|||||||Mixed Models Analysis|||||||.004
72521249|NCT02580591|144571079|SUPERIORITY||Mean Difference (Final Values)|-0.28|STANDARD_ERROR_OF_MEAN|0.07|<|0.0001|TWO_SIDED|99.0|-0.46|-0.11|||Mixed effect Model Repeat Measurement||Mean Difference= Empagliflozin 2.5 milligram (mg) adjusted mean - Placebo matching Empagliflozin adjusted mean.|Model includes baseline HbA1c, baseline Estimated glomerular filtration rate (eGFR) as linear covariates and baseline pre-existing insulin therapy, treatment, visit, visit by treatment interaction, baseline HbA1c by visit interaction as fixed effects. Patient is included as random effect. An unstructured covariance structure was used to model the within-patient measurements.||-0.11|-0.46|<0.0001
72521250|NCT02580591|144571079|SUPERIORITY||Mean Difference (Final Values)|-0.45|STANDARD_ERROR_OF_MEAN|0.07|<|0.0001|TWO_SIDED|97.5|-0.6|-0.3|||Mixed effect Model Repeat Measurement||Mean Difference= Empagliflozin 10 milligram (mg) adjusted mean - Placebo matching Empagliflozin adjusted mean.|Model includes baseline HbA1c, baseline eGFR as linear covariates and baseline pre-existing insulin therapy, treatment, visit, visit by treatment interaction, baseline HbA1c by visit interaction as fixed effects. Patient is included as random effect. An unstructured covariance structure was used to model the within-patient measurements.||-0.30|-0.60|<0.0001
72521251|NCT02580591|144571079|SUPERIORITY||Mean Difference (Final Values)|-0.52|STANDARD_ERROR_OF_MEAN|0.07|<|0.0001|TWO_SIDED|97.5|-0.68|-0.37|||Mixed effect Model Repeat Measurement||Mean Difference= Empagliflozin 25 milligram (mg) adjusted mean - Placebo matching Empagliflozin adjusted mean.|Model includes baseline HbA1c, baseline eGFR as linear covariates and baseline pre-existing insulin therapy, treatment, visit, visit by treatment interaction, baseline HbA1c by visit interaction as fixed effects. Patient is included as random effect. An unstructured covariance structure was used to model the within-patient measurements.||-0.37|-0.68|<0.0001
72521252|NCT02580591|144571080|SUPERIORITY||Mean Difference (Final Values)|-0.27|STANDARD_ERROR_OF_MEAN|0.07|||TWO_SIDED|95.0|-0.4|-0.14|||Mixed effect Model Repeat Measurement||Mean Difference= Empagliflozin 2.5 milligram (mg) adjusted mean - Placebo matching Empagliflozin adjusted mean.|Model includes baseline HbA1c, baseline eGFR as linear covariates and baseline pre-existing insulin therapy, treatment, visit, visit by treatment interaction, baseline HbA1c by visit interaction as fixed effects. Patient is included as random effect. An unstructured covariance structure was used to model the within-patient measurements.||-0.14|-0.40|
72521253|NCT02580591|144571080|SUPERIORITY||Median Difference (Final Values)|-0.44|STANDARD_ERROR_OF_MEAN|0.07|<|0.0001|TWO_SIDED|97.5|-0.59|-0.28|||Mixed effect Model Repeat Measurement||Mean Difference= Empagliflozin 2.5 milligram (mg) adjusted mean - Placebo matching Empagliflozin adjusted mean.|Model includes baseline HbA1c, baseline eGFR as linear covariates and baseline pre-existing insulin therapy, treatment, visit, visit by treatment interaction, baseline HbA1c by visit interaction as fixed effects. Patient is included as random effect. An unstructured covariance structure was used to model the within-patient measurements.||-0.28|-0.59|<0.0001
72521254|NCT02580591|144571080|SUPERIORITY||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|0.07|<|0.0001|TWO_SIDED|97.5|-0.66|-0.35|||Mixed effect Model Repeat Measurement||Mean Difference= Empagliflozin 25 milligram (mg) adjusted mean - Placebo matching Empagliflozin adjusted mean.|Model includes baseline HbA1c, baseline eGFR as linear covariates and baseline pre-existing insulin therapy, treatment, visit, visit by treatment interaction, baseline HbA1c by visit interaction as fixed effects. Patient is included as random effect. An unstructured covariance structure was used to model the within-patient measurements.||-0.35|-0.66|<0.0001
72521255|NCT02580591|144571081|SUPERIORITY||Adjusted Rate Ratio (%)|0.94|||||TWO_SIDED|95.0|0.673|1.314|||Negative binomial model||Empagliflozin 2.5 milligram (mg) adjusted rate/Placebo matching Empagliflozin adjusted rate.|For Week 5 to 26, negative binomial model includes baseline rate of hypoglycemia, baseline HbA1c, and baseline Estimated glomerular filtration rate (eGFR) as linear covariates and baseline pre-existing insulin therapy and treatment as fixed effects. Log (time at risk \[days\]) was used as offset.||1.314|0.673|
72569876|NCT02504671|144670130|OTHER||Mean Difference (Net)|-2.58||||0.495|TWO_SIDED|95.0|-10.04|4.87||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||CRP, Week 12|||4.87|-10.04|0.495
72624994|NCT05395338|144779498|OTHER|Conditional logistic regression models with stratification by matching pairs.|Odds Ratio (OR)|1.23|||<|0.001|TWO_SIDED|95.0|1.11|1.36|||Regression, Logistic||rt-PA/non reperfusion|||1.36|1.11|<0.001
72521256|NCT02580591|144571081|SUPERIORITY||Adjusted Rate Ratio (%)|1.202||||0.2752|TWO_SIDED|97.75|0.818|1.766|||Negative binomial model||Empagliflozin 10 milligram (mg) adjusted rate/Placebo matching Empagliflozin adjusted rate.|For Week 5 to 26, negative binomial model includes baseline rate of hypoglycemia, baseline HbA1c, and baseline Estimated glomerular filtration rate (eGFR) as linear covariates and baseline pre-existing insulin therapy and treatment as fixed effects. Log (time at risk \[days\]) was used as offset.||1.766|0.818|0.2752
72569877|NCT02504671|144670130|OTHER||Mean Difference (Net)|-7.68||||0.14|TWO_SIDED|95.0|-17.92|2.55||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||PtGA, Week 12|||2.55|-17.92|0.140
72521257|NCT02580591|144571081|SUPERIORITY||Adjusted Rate Ratio (%)|1.02||||0.9077|TWO_SIDED|97.75|0.693|1.501|||Negative binomial model||Empagliflozin 25 milligram (mg) adjusted rate/Placebo matching Empagliflozin adjusted rate.|For Week 5 to 26, negative binomial model includes baseline rate of hypoglycemia, baseline HbA1c, and baseline Estimated glomerular filtration rate (eGFR) as linear covariates and baseline pre-existing insulin therapy and treatment as fixed effects. Log (time at risk \[days\]) was used as offset.||1.501|0.693|0.9077
72521258|NCT02580591|144571081|SUPERIORITY||Adjusted Rate Ratio (%)|0.932|||||TWO_SIDED|95.0|0.682|1.274|||Negative binomial model|||For Week 1 to 26, negative binomial model includes baseline rate of hypoglycemia, baseline HbA1c, and baseline Estimated glomerular filtration rate (eGFR) as linear covariates and baseline pre-existing insulin therapy and treatment as fixed effects. Log (time at risk \[days\]) was used as offset.||1.274|0.682|
72521259|NCT02580591|144571081|SUPERIORITY||Adjusted Rate Ratio (%)|1.258||||0.1438|TWO_SIDED|95.0|0.925|1.713||This is a nominal p-value.|Negative binomial model||Empagliflozin 10 milligram (mg) adjusted rate/Placebo matching Empagliflozin adjusted rate.|For Week 1 to 26, negative binomial model includes baseline rate of hypoglycemia, baseline HbA1c, and baseline Estimated glomerular filtration rate (eGFR) as linear covariates and baseline pre-existing insulin therapy and treatment as fixed effects. Log (time at risk \[days\]) was used as offset.||1.713|0.925|0.1438
72521260|NCT02580591|144571081|SUPERIORITY||Adjusted Rate Ratio (%)|1.051||||0.7543|TWO_SIDED|95.0|0.771|1.433||This is a nominal p-value.|Negative binomial model||Empagliflozin 25 milligram (mg) adjusted rate/Placebo matching Empagliflozin adjusted rate.|For Week 1 to 26, negative binomial model includes baseline rate of hypoglycemia, baseline HbA1c, and baseline Estimated glomerular filtration rate (eGFR) as linear covariates and baseline pre-existing insulin therapy and treatment as fixed effects. Log (time at risk \[days\]) was used as offset.||1.433|0.771|0.7543
72521261|NCT02580591|144571082|SUPERIORITY||Mean Difference (Final Values)|-1.76|||||TWO_SIDED|95.0|-2.32|-1.2|||Mixed effect Model Repeat Measurement||Mean Difference= Empagliflozin 2.5 milligram (mg) adjusted mean - Placebo matching Empagliflozin adjusted mean.|Model includes baseline weight, baseline Estimated glomerular filtration rate (eGFR), baseline HbA1c as linear covariate and baseline pre-existing insulin therapy, treatment, visit, visit by treatment interaction, baseline weight by visit interaction as fixed effect. An unstructured covariance structure was used to model the within-patient measurements.||-1.20|-2.32|
72521262|NCT02580591|144571082|SUPERIORITY||Mean Difference (Final Values)|-3.04|||<|0.0001|TWO_SIDED|99.75|-3.91|-2.18|||Mixed effect Model Repeat Measurement||Mean Difference= Empagliflozin 10 milligram (mg) adjusted mean - Placebo matching Empagliflozin adjusted mean.|Model includes baseline weight, baseline Estimated glomerular filtration rate (eGFR), baseline HbA1c as linear covariate and baseline pre-existing insulin therapy, treatment, visit, visit by treatment interaction, baseline weight by visit interaction as fixed effect. An unstructured covariance structure was used to model the within-patient measurements.||-2.18|-3.91|<0.0001
72521263|NCT02580591|144571082|SUPERIORITY||Mean Difference (Final Values)|-3.43|||<|0.0001|TWO_SIDED|99.75|-4.3|-2.57|||Mixed effect Model Repeat Measurement||Mean Difference= Empagliflozin 25 milligram (mg) adjusted mean - Placebo matching Empagliflozin adjusted mean.|Model includes baseline weight, baseline Estimated glomerular filtration rate (eGFR), baseline HbA1c as linear covariate and baseline pre-existing insulin therapy, treatment, visit, visit by treatment interaction, baseline weight by visit interaction as fixed effect. An unstructured covariance structure was used to model the within-patient measurements.||-2.57|-4.30|<0.0001
72521264|NCT02580591|144571083|SUPERIORITY||Mean Difference (Final Values)|-0.049|||||TWO_SIDED|95.0|-0.069|-0.03|||Mixed effect Model Repeat Measurement||Mean Difference= Empagliflozin 2.5 milligram (mg) adjusted mean - Placebo matching Empagliflozin adjusted mean.|Model includes baseline total daily insulin dose, baseline estimated glomerular filtration rate (eGFR), baseline HbA1c as linear covariate and baseline pre-existing insulin therapy, treatment, visit, visit by treatment interaction, baseline total daily insulin dose by visit interaction as fixed effect. An unstructured covariance structure was used to model the within-patient measurements.||-0.030|-0.069|
72521265|NCT02580591|144571083|SUPERIORITY||Mean Difference (Final Values)|-0.07|||<|0.0001|TWO_SIDED|99.75|-0.101|-0.039|||Mixed effect Model Repeat Measurement||Mean Difference= Empagliflozin 10 milligram (mg) adjusted mean - Placebo matching Empagliflozin adjusted mean.|Model includes baseline total daily insulin dose, baseline estimated glomerular filtration rate (eGFR), baseline HbA1c as linear covariate and baseline pre-existing insulin therapy, treatment, visit, visit by treatment interaction, baseline total daily insulin dose by visit interaction as fixed effect. An unstructured covariance structure was used to model the within-patient measurements.||-0.039|-0.101|<0.0001
72521266|NCT02580591|144571083|SUPERIORITY||Mean Difference (Final Values)|-0.091|STANDARD_ERROR_OF_MEAN|0.01|<|0.0001|TWO_SIDED|99.75|-0.122|-0.06|||Mixed effect Model Repeat Measurement||Mean Difference= Empagliflozin 25 milligram (mg) adjusted mean - Placebo matching Empagliflozin adjusted mean.|Model includes baseline total daily insulin dose, baseline estimated glomerular filtration rate (eGFR), baseline HbA1c as linear covariate and baseline pre-existing insulin therapy, treatment, visit, visit by treatment interaction, baseline total daily insulin dose by visit interaction as fixed effect. An unstructured covariance structure was used to model the within-patient measurements.||-0.060|-0.122|<0.0001
72569878|NCT02504671|144670130|OTHER||Mean Difference (Net)|-13.68||||0.009|TWO_SIDED|95.0|-23.85|-3.52||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||PtGA, Week 12|||-3.52|-23.85|0.009
72569879|NCT02504671|144670130|OTHER||Mean Difference (Net)|-17.4|||<|0.001|TWO_SIDED|95.0|-27.44|-7.35||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||PtGA, Week 12|||-7.35|-27.44|<0.001
72569880|NCT02504671|144670130|OTHER||Mean Difference (Net)|-2.42||||0.118|TWO_SIDED|95.0|-5.45|0.62||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||SJC28, Week 12|||0.62|-5.45|0.118
72569881|NCT02504671|144670130|OTHER||Mean Difference (Net)|-3.17||||0.041|TWO_SIDED|95.0|-6.2|-0.14||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||SJC28, Week 12|||-0.14|-6.20|0.041
72369308|NCT00611026|144248568|SUPERIORITY_OR_OTHER|||||||0.0003|TWO_SIDED||||||Cochran-Mantel-Haenszel|P-value based on Cochran-Mantel-Haenszel test stratified by baseline UUI quartile.||Treatment difference in continent rate for fesoterodine vs placebo at Week 12.||||0.0003
72624995|NCT05395338|144779499|OTHER|Conditional logistic regression models with stratification by matching pairs|Odds Ratio (OR)|0.73|||<|0.001|TWO_SIDED|95.0|0.64|0.83|||Regression, Logistic||rt-PA/non reperfusion|||0.83|0.64|<0.001
72521267|NCT02580591|144571084|SUPERIORITY||Median Difference (Final Values)|-2.1|||||TWO_SIDED|95.0|-3.9|-0.2|||Mixed effect Model Repeat MeasurementMix||Mean Difference= Empagliflozin 2.5 milligram (mg) adjusted mean - Placebo matching Empagliflozin adjusted mean.|For SBP, the model includes baseline SBP seated, baseline Estimated glomerular filtration rate (eGFR), baseline HbA1c as linear covariate and baseline pre-existing insulin therapy, treatment, visit, treatment by visit interaction, baseline SBP seated by visit interaction as fixed effect. An unstructured covariance structure was used to model the within-patient measurements.||-0.2|-3.9|
72521268|NCT02580591|144571084|SUPERIORITY||Mean Difference (Final Values)|-3.9|||<|0.0001|TWO_SIDED|99.75|-6.8|-1.1|||Mixed effect Model Repeat Measurement||Mean Difference= Empagliflozin 10 milligram (mg) adjusted mean - Placebo matching Empagliflozin adjusted mean.|For SBP, the model includes baseline SBP seated, baseline Estimated glomerular filtration rate (eGFR), baseline HbA1c as linear covariate and baseline pre-existing insulin therapy, treatment, visit, , treatment by visit interaction, baseline SBP seated by visit interaction as fixed effect. An unstructured covariance structure was used to model the within-patient measurements.||-1.1|-6.8|<0.0001
72521269|NCT02580591|144571084|SUPERIORITY||Mean Difference (Final Values)|-3.7|||<|0.0001|TWO_SIDED|99.75|-6.6|-0.9|||Mixed effect Model Repeat Measurement||Mean Difference= Empagliflozin 25 milligram (mg) adjusted mean - Placebo matching Empagliflozin adjusted mean.|For SBP, the model includes baseline SBP seated, baseline Estimated glomerular filtration rate (eGFR), baseline HbA1c as linear covariate and baseline pre-existing insulin therapy, treatment, visit, treatment by visit interaction, baseline SBP seated by visit interaction as fixed effect. An unstructured covariance structure was used to model the within-patient measurements.||-0.9|-6.6|<0.0001
72521270|NCT02580591|144571084|SUPERIORITY||Mean Difference (Final Values)|-0.3|||||TWO_SIDED|95.0|-1.5|0.9|||Mixed effect Model Repeat Measurement||Mean Difference= Empagliflozin 2.5 milligram (mg) adjusted mean - Placebo matching Empagliflozin adjusted mean.|For DBP, the model includes baseline DBP seated, baseline Estimated glomerular filtration rate (eGFR), baseline HbA1c as linear covariate and baseline pre-existing insulin therapy, treatment, visit, treatment by visit interaction, baseline DBP seated by visit interaction as fixed effect. An unstructured covariance structure was used to model the within-patient measurements.||0.9|-1.5|
72521271|NCT02580591|144571084|SUPERIORITY||Mean Difference (Final Values)|-1.7||||0.0047|TWO_SIDED|99.75|-3.6|0.1|||Mixed effect Model Repeat Measurement||Mean Difference= Empagliflozin 2.5 milligram (mg) adjusted mean - Placebo matching Empagliflozin adjusted mean.|For DBP, the model includes baseline DBP seated, baseline Estimated glomerular filtration rate (eGFR), baseline HbA1c as linear covariate and baseline pre-existing insulin therapy, treatment, visit, ß, treatment by visit interaction, baseline DBP seated by visit interaction as fixed effect. An unstructured covariance structure was used to model the within-patient measurements.||0.1|-3.6|0.0047
72521272|NCT02580591|144571084|SUPERIORITY||Mean Difference (Final Values)|-1.4||||0.0202|TWO_SIDED|99.75|-3.3|0.4|||Mixed effect Model Repeat Measurement|||For DBP, the model includes baseline DBP seated, baseline Estimated glomerular filtration rate (eGFR), baseline HbA1c as linear covariate and baseline pre-existing insulin therapy, treatment, visit, ß, treatment by visit interaction, baseline DBP seated by visit interaction as fixed effect. An unstructured covariance structure was used to model the within-patient measurements.||0.4|-3.3|0.0202
72521273|NCT03051217|144571092|SUPERIORITY||Estimated difference in responder rate|65.1|||||TWO_SIDED|95.0|48.22|81.9|||Regression, Logistic|If there is a group without a responder, in this case the biological exposure will be excluded from the model, an exact logistic regression applied.|If there is a group without a responder, in this case the biological exposure will be excluded from the model, an exact logistic regression applied.|The primary and secondary efficacy endpoints were evaluated using a fixed-sequence testing procedure to account for multiplicity.||81.90|48.22|
72521274|NCT03051217|144571092|SUPERIORITY||Estimated difference in responder rate|79.1|||||TWO_SIDED|95.0|65.1|93.17|||Regression, Logistic|If there is a group without a responder, in this case the biological exposure will be excluded from the model, an exact logistic regression applied.|If there is a group without a responder, in this case the biological exposure will be excluded from the model, an exact logistic regression applied.|The primary and secondary efficacy endpoints were evaluated using a fixed-sequence testing procedure to account for multiplicity.||93.17|65.10|
72521275|NCT03051217|144571092|SUPERIORITY||Odds Ratio (OR)|31.695|||<|0.0001|TWO_SIDED|97.5|5.129|195.877||The p-value for the primary analysis was evaluated at a 2-sided significance level of 0.025 for each CZP dose vs PBO.|Regression, Logistic|If there is a group without a responder, in this case the biological exposure will be excluded from the model, an exact logistic regression applied.||The primary and secondary efficacy endpoints were evaluated using a fixed-sequence testing procedure to account for multiplicity.||195.877|5.129|<0.0001
72521276|NCT03051217|144571092|SUPERIORITY||Odds Ratio (OR)|79.112|||<|0.0001|TWO_SIDED|97.5|11.739|533.168||The p-value for the primary analysis was evaluated at a 2-sided significance level of 0.025 for each CZP dose vs PBO.|Regression, Logistic|If there is a group without a responder, in this case the biological exposure will be excluded from the model, an exact logistic regression applied.||The primary and secondary efficacy endpoints were evaluated using a fixed-sequence testing procedure to account for multiplicity.||533.168|11.739|<0.0001
72521277|NCT03051217|144571093|SUPERIORITY||Estimated difference in responder rate|52.7|||||TWO_SIDED|95.0|29.95|75.39|||Regression, Logistic|If there is a group without a responder, in this case the biological exposure will be excluded from the model, an exact logistic regression applied.|If there is a group without a responder, in this case the biological exposure will be excluded from the model, an exact logistic regression applied.|The primary and secondary efficacy endpoints were evaluated using a fixed-sequence testing procedure to account for multiplicity.||75.39|29.95|
72624996|NCT05395338|144779500|OTHER|Ordinal logistic regression models|Odds Ratio (OR)|0.85|||<|0.001|TWO_SIDED|95.0|0.77|0.93|||Regression, Logistic||rt-PA/non reperfusion|||0.93|0.77|<0.001
72369309|NCT00611026|144248568|SUPERIORITY_OR_OTHER|||||||0.0991|TWO_SIDED||||||Cochran-Mantel-Haenszel|P-value based on Cochran-Mantel-Haenszel test stratified by baseline UUI quartile.||Treatment difference in continent rate for Tolterodine ER vs placebo at Week 12.||||0.0991
72405933|NCT04074317|144320321|OTHER||Ratio of least-squares means|103.89|||>|0.9999|TWO_SIDED|||||Bonferroni-adjusted p-value to maintain the overall Type 1 error rate at 0.05.|ANOVA||Ratio calculated as PRAM least-squares mean divided by the Regular Insulin + Pramlintide least-squares mean, expressed as a percentage.|The statistical model was an analysis of variance (ANOVA) with sequence, period, and treatment as fixed effect and subject nested within sequence as a random effect.||||>0.9999
72405934|NCT04074317|144320321|OTHER||Ratio of least-square means|141.29||||0.1747|TWO_SIDED|||||Bonferroni-adjusted p-value to maintain the overall Type 1 error rate at 0.05.|ANOVA||Ratio calculated as Regular Insulin least-squares mean divided by the Regular Insulin + Pramlintide least-squares mean, expressed as a percentage.|The statistical model was an analysis of variance (ANOVA) with sequence, period, and treatment as fixed effect and subject nested within sequence as a random effect.||||0.1747
72405935|NCT04074317|144320322|EQUIVALENCE|"Bioequivalence would require the 90% confidence intervals of the geometric mean ratio to be contained within the 80 - 125% range.~H0: Means are equal between treatment groups. Ha: Means are not equal across the treatment groups."|Ratio of geometric least-squares means|53.16|||<|0.0001|TWO_SIDED|90.0|43.59|64.83||Bonferroni-adjusted p-value to maintain the overall Type 1 error rate at 0.05.|ANOVA||"Ratio calculated as PRAM geometric least-squares mean divided by the Regular Insulin geometric least-squares mean, expressed as a percentage.~Confidence interval on the ratio, expressed as a percentage."|AUC 0 to 90 The statistical model was an analysis of variance (ANOVA) on the ln-transformed data with sequence, period, and treatment as fixed effect and subject nested within sequence as a random effect.||64.83|43.59|<0.0001
72405936|NCT04074317|144320322|EQUIVALENCE|"Bioequivalence would require the 90% confidence intervals of the geometric mean ratio to be contained within the 80 - 125% range.~H0: Means are equal between treatment groups. Ha: Means are not equal across the treatment groups."|Ratio of geometric least-squares means|65.24||||0.0018|TWO_SIDED|90.0|54.02|78.8||Bonferroni-adjusted p-value to maintain the overall Type 1 error rate at 0.05|ANOVA||"Ratio calculated as PRAM geometric least-squares mean divided by the Regular Insulin + Pramlintide geometric least-squares mean, expressed as a percentage.~Confidence interval on the ratio, expressed as a percentage."|AUC 0 to 90 The statistical model was an analysis of variance (ANOVA) on the ln-transformed data with sequence, period, and treatment as fixed effect and subject nested within sequence as a random effect.||78.80|54.02|0.0018
72405937|NCT04074317|144320322|EQUIVALENCE|"Bioequivalence would require the 90% confidence intervals of the geometric mean ratio to be contained within the 80 - 125% range.~H0: Means are equal between treatment groups. Ha: Means are not equal across the treatment groups."|Ratio of geometric least-squares means|122.73||||0.2391|TWO_SIDED|90.0|101.33|148.66||Bonferroni-adjusted p-value to maintain the overall Type 1 error rate at 0.05|ANOVA||"Ratio calculated as Regular Insulin geometric least-squares mean divided by the Regular Insulin + Pramlintide geometric least-squares mean, expressed as a percentage.~Confidence interval on the ratio, expressed as a percentage."|AUC 0 to 90 The statistical model was an analysis of variance (ANOVA) on the ln-transformed data with sequence, period, and treatment as fixed effect and subject nested within sequence as a random effect.||148.66|101.33|0.2391
72405938|NCT04074317|144320322|EQUIVALENCE|"Bioequivalence would require the 90% confidence intervals of the geometric mean ratio to be contained within the 80 - 125% range.~H0: Means are equal between treatment groups. Ha: Means are not equal across the treatment groups."|Ratio of geometric least-squares means|54.2|||<|0.0001|TWO_SIDED|90.0|47.58|61.73||Bonferroni-adjusted p-value to maintain the overall Type 1 error rate at 0.05.|ANOVA||"Ratio calculated as PRAM geometric least-squares mean divided by the Regular Insulin geometric least-squares mean, expressed as a percentage.~Confidence interval on the ratio, expressed as a percentage."|AUC 0 to 180 The statistical model was an analysis of variance (ANOVA) on the ln-transformed data with sequence, period, and treatment as fixed effect and subject nested within sequence as a random effect.||61.73|47.58|<0.0001
72405939|NCT04074317|144320322|EQUIVALENCE|"Bioequivalence would require the 90% confidence intervals of the geometric mean ratio to be contained within the 80 - 125% range.~H0: Means are equal between treatment groups. Ha: Means are not equal across the treatment groups."|Ratio of geometric least-squares means|71.29||||0.0002|TWO_SIDED|90.0|62.99|80.69||Bonferroni-adjusted p-value to maintain the overall Type 1 error rate at 0.05|ANOVA||"Ratio calculated as PRAM geometric least-squares mean divided by the Regular Insulin + Pramlintide geometric least-squares mean, expressed as a percentage.~Confidence interval on the ratio, expressed as a percentage."|AUC 0 to 180 The statistical model was an analysis of variance (ANOVA) on the ln-transformed data with sequence, period, and treatment as fixed effect and subject nested within sequence as a random effect.||80.69|62.99|0.0002
72521278|NCT03051217|144571093|SUPERIORITY||Estimated difference in responder rate|66.7|||||TWO_SIDED|95.0|43.34|90.15|||Regression, Logistic|If there is a group without a responder, in this case the biological exposure will be excluded from the model, an exact logistic regression applied.|If there is a group without a responder, in this case the biological exposure will be excluded from the model, an exact logistic regression applied.|The primary and secondary efficacy endpoints were evaluated using a fixed-sequence testing procedure to account for multiplicity.||90.15|43.34|
72521279|NCT03051217|144571093|SUPERIORITY||Odds Ratio (OR)|38.193|||<|0.0001|TWO_SIDED|97.5|6.113|238.619||The p-value for the primary analysis was evaluated at a 2-sided significance level of 0.025 for each CZP dose vs PBO.|Regression, Logistic|If there is a group without a responder, in this case the biological exposure will be excluded from the model, an exact logistic regression applied.||The primary and secondary efficacy endpoints were evaluated using a fixed-sequence testing procedure to account for multiplicity.||238.619|6.113|<0.0001
72569882|NCT02504671|144670130|OTHER||Mean Difference (Net)|-4.56||||0.003|TWO_SIDED|95.0|-6.0|0.05||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||SJC28, Week 12|||0.05|-6.00|0.003
72569883|NCT02504671|144670130|OTHER||Mean Difference (Net)|-2.3||||0.172|TWO_SIDED|95.0|-5.61|1.01||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||TC28, Week 12|||1.01|-5.61|0.172
72569884|NCT02504671|144670130|OTHER||Mean Difference (Net)|-3.92||||0.02|TWO_SIDED|95.0|-7.22|-0.62||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||TJC28, Week 12|||-0.62|-7.22|0.020
72569885|NCT02504671|144670130|OTHER||Mean Difference (Net)|-5.72|||<|0.001|TWO_SIDED|95.0|-8.98|-2.45||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||TJC28, Week 12|||-2.45|-8.98|<0.001
72569886|NCT02504671|144670130|OTHER||Mean Difference (Net)|-2.51||||0.518|TWO_SIDED|95.0|-10.13|5.12||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||CRP, Week 12|||5.12|-10.13|0.518
72521280|NCT03051217|144571093|SUPERIORITY||Odds Ratio (OR)|69.58|||<|0.0001|TWO_SIDED|97.5|11.138|434.659||The p-value for the primary analysis was evaluated at a 2-sided significance level of 0.025 for each CZP dose vs PBO.|Regression, Logistic|If there is a group without a responder, in this case the biological exposure will be excluded from the model, an exact logistic regression applied.||The primary and secondary efficacy endpoints were evaluated using a fixed-sequence testing procedure to account for multiplicity.||434.659|11.138|<0.0001
72521281|NCT03051217|144571094|SUPERIORITY||Estimated difference in responder rate|53.6|||||TWO_SIDED|95.0|30.67|76.47|||Regression, Logistic|If there is a group without a responder, in this case the biological exposure will be excluded from the model, an exact logistic regression applied.|If there is a group without a responder, in this case the biological exposure will be excluded from the model, an exact logistic regression applied.|The primary and secondary efficacy endpoints were evaluated using a fixed-sequence testing procedure to account for multiplicity.||76.47|30.67|
72521282|NCT03051217|144571094|SUPERIORITY||Estimated difference in responder rate|75.5|||||TWO_SIDED|95.0|51.95|99.04|||Regression, Logistic|If there is a group without a responder, in this case the biological exposure will be excluded from the model, an exact logistic regression applied.|If there is a group without a responder, in this case the biological exposure will be excluded from the model, an exact logistic regression applied.|The primary and secondary efficacy endpoints were evaluated using a fixed-sequence testing procedure to account for multiplicity.||99.04|51.95|
72521283|NCT03051217|144571094|SUPERIORITY||Odds Ratio (OR)|38.696|||<|0.0001|TWO_SIDED|97.5|6.047|247.634||The p-value for the primary analysis was evaluated at a 2-sided significance level of 0.025 for each CZP dose vs PBO.|Regression, Logistic|If there is a group without a responder, in this case the biological exposure will be excluded from the model, an exact logistic regression applied.||The primary and secondary efficacy endpoints were evaluated using a fixed-sequence testing procedure to account for multiplicity.||247.634|6.047|<0.0001
72521284|NCT03051217|144571094|SUPERIORITY||Odds Ratio (OR)|100.459|||<|0.0001|TWO_SIDED|97.5|15.54|649.437||The p-value for the primary analysis was evaluated at a 2-sided significance level of 0.025 for each CZP dose vs PBO.|Regression, Logistic|If there is a group without a responder, in this case the biological exposure will be excluded from the model, an exact logistic regression applied.||The primary and secondary efficacy endpoints were evaluated using a fixed-sequence testing procedure to account for multiplicity.||649.437|15.540|<0.0001
72521285|NCT03051217|144571095|SUPERIORITY||Adjusted Mean Treatment Difference|-6.5|||<|0.0001|TWO_SIDED|97.5|-9.1|-3.844||p-value obtained for each treatment group comparison tested at a significance level of 0.025 in the fixed sequence testing procedure.|ANCOVA|ANCOVA model of change from Baseline DLQI score with treatment group and prior biologic exposure as factors and Baseline DLQI score as a covariate.||The primary and secondary efficacy endpoints were evaluated using a fixed-sequence testing procedure to account for multiplicity.||-3.844|-9.100|<0.0001
72521286|NCT03051217|144571095|SUPERIORITY||Adjusted Mean Treatment Difference|-6.5|||<|0.0001|TWO_SIDED|97.5|-9.099|-3.91||p-value obtained for each treatment group comparison tested at a significance level of 0.025 in the fixed sequence testing procedure.|ANCOVA|ANCOVA model of change from Baseline DLQI score with treatment group and prior biologic exposure as factors and Baseline DLQI score as a covariate.||The primary and secondary efficacy endpoints were evaluated using a fixed-sequence testing procedure to account for multiplicity.||-3.910|-9.099|<0.0001
72521287|NCT03051217|144571096|SUPERIORITY||Adjusted Mean Treatment Difference|-3.1|||<|0.0001|TWO_SIDED|95.0|-4.265|-2.002||p-value obtained for each treatment group comparison tested at a significance level of 0.025 in the fixed sequence testing procedure.|ANCOVA|ANCOVA model of change from Baseline Itch NRS with treatment group and prior biologic exposure as factors and Baseline Itch NRS as a covariate.||The primary and secondary efficacy endpoints were evaluated using a fixed-sequence testing procedure to account for multiplicity.||-2.002|-4.265|<0.0001
72521288|NCT03051217|144571096|SUPERIORITY||Adjusted Mean Treatment Difference|-4.2|||<|0.0001|TWO_SIDED|95.0|-5.295|-3.069||p-value obtained for each treatment group comparison tested at a significance level of 0.025 in the fixed sequence testing procedure.|ANCOVA|ANCOVA model of change from Baseline Itch NRS with treatment group and prior biologic exposure as factors and Baseline Itch NRS as a covariate.||The primary and secondary efficacy endpoints were evaluated using a fixed-sequence testing procedure to account for multiplicity.||-3.069|-5.295|<0.0001
72521289|NCT00109772|144571099|SUPERIORITY_OR_OTHER|||||||0.894||95.0|||||Cochran-Mantel-Haenszel|controlled for centers||||||.8940
72521290|NCT03437044|144571116|SUPERIORITY|||||||0.001|||||||ANCOVA|the corresponding baseline value of platelet reactivity was used as covariate||||||0.001
72521291|NCT03437044|144571117|SUPERIORITY||||||<|0.001|||||||ANCOVA|the corresponding baseline value of platelet reactivity was used as covariate||||||<0.001
72521292|NCT01359046|144571118|SUPERIORITY|||||||0.3|||||||Wilcoxon (Mann-Whitney)|||||||0.30
72521293|NCT01359046|144571119|SUPERIORITY|||||||0.68|||||||Wilcoxon (Mann-Whitney)|||||||0.68
72521294|NCT01057862|144571120|OTHER|We are including the mean and SD of each arm at the start and end of study only as a comparison and not a meaningful analysis. Since higher scores represent a more severe form of the disorder, a drop in scores is seen as an indicator that the treatment had an effect.|Mean Difference (Final Values)|6.0|STANDARD_DEVIATION|9.35|||TWO_SIDED||||||||The active arm had a mean PG-YBOCS score of 16 (n=5) at study start with a SD of 7.35. At end of study the active arm had a mean PG-YBOCS score of 10 (n=5) with a SD of 9.35. The placebo arm is not included here as there were only two scores.|Enrollment was lower than expected and due to the low numbers of subjects completing the study (7 subjects (5 active and 2 placebo) completed all interventions) the numbers were not powerful enough to conduct a full analysis or provide any meaningful statistical analyses. We are including the mean and SD of each arm at the beginning and end of the study only as a comparison and not as a meaningful analysis.||||
72569887|NCT02504671|144670130|OTHER||Mean Difference (Net)|-2.0||||0.599|TWO_SIDED|95.0|-9.5|5.49||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||CRP, Week 12|||5.49|-9.50|0.599
72521295|NCT01057862|144571121|OTHER|We are including the mean and SD of each arm at the start and end of study only as a comparison and not a meaningful analysis. Since higher scores represent a more severe form of the disorder, a drop in scores is seen as an indicator that the treatment had an effect.|Mean Difference (Final Values)|14.2|STANDARD_DEVIATION|9.45|||TWO_SIDED||||||||The active treatment arm had a mean G-SAS score of 26.8 (n=5) at study start with a SD of 11.73. At end the active treatment arm had a mean G-SAS score of 12.6 (n=5) with a SD of 9.45. The placebo arm is not included as there were only 2 scores.|Enrollment was lower than expected and due to the low numbers of subjects completing the study (7 subjects (5 active and 2 placebo) completed all interventions) the numbers were not powerful enough to conduct a full analysis or provide any meaningful statistical analyses. We are including the mean and SD of each arm at the beginning and end of the study only as a comparison and not as a meaningful analysis.||||
72521296|NCT03434041|144571131|SUPERIORITY||Difference of Least Square (LS) Means|-2.0||||0.123|TWO_SIDED|95.0|-4.64|0.55||2-sided|Mixed-effects Model for Repeated Measure|||||0.55|-4.64|0.123
72521297|NCT03434041|144571132|SUPERIORITY||Difference of LS Means|-3.3|||||TWO_SIDED|95.0|-5.33|-1.33||||||||-1.33|-5.33|
72521298|NCT03434041|144571133|SUPERIORITY||Difference of LS Means|-1.0|||||TWO_SIDED|95.0|-2.96|0.97||||||||0.97|-2.96|
72521299|NCT00444080|144571187|OTHER|||||||0.013|||||||Fisher Exact|||||||0.013
72521300|NCT03363165|144571194|SUPERIORITY||Mean Difference (Final Values)|-13.54||||0.7586|ONE_SIDED|90.0|-38.52||||ANCOVA|Adjusted for baseline six-minute walk distance, age, race, former smoker.|||||-38.52|0.7586
72521301|NCT03363165|144571195|SUPERIORITY||Mean Difference (Final Values)|2.25||||0.0298|ONE_SIDED|90.0|0.78||||ANCOVA|Adjusted for baseline maximal treadmill walking time, age, race, former smoker|||||0.78|0.0298
72521302|NCT03363165|144571196|SUPERIORITY||Mean Difference (Final Values)|0.69||||0.4019|ONE_SIDED|90.0|-3.1||||ANCOVA|Adjusted for baseline perfusion, age, race, former smoker.|||||-3.10|0.4019
72521303|NCT03363165|144571197|SUPERIORITY||Mean Difference (Final Values)|8.28||||0.208|ONE_SIDED|90.0|-5.37||||ANCOVA|Adjusted for baseline muscle measure, age, race, former smoker.|||||-5.37|0.2080
72521304|NCT03363165|144571198|SUPERIORITY||Mean Difference (Final Values)|2.02||||0.398|ONE_SIDED|90.0|-8.11||||ANCOVA|Adjusted for baseline WIQ distance score, age, race, former smoker|||||-8.11|0.3980
72521305|NCT03363165|144571199|SUPERIORITY||Mean Difference (Final Values)|-5.5||||0.7852|ONE_SIDED|90.0|-14.5||||ANCOVA|Adjusted for baseline SF-36 physical functioning score, age, race, former smoker.|||||-14.50|0.7852
72521306|NCT03363165|144571200|SUPERIORITY||Mean Difference (Final Values)|-5.14||||0.8414|ONE_SIDED|90.0|-11.76||||ANCOVA|Adjusted for baseline SF-36 physical functioning score, age, race, former smoker.|||||-11.76|0.8414
72521307|NCT03363165|144571201|SUPERIORITY||Mean Difference (Final Values)|-2.13||||0.5912|ONE_SIDED|90.0|-14.11||||ANCOVA|Adjusted for baseline WIQ distance score, age, race, former smoker.|||||-14.11|0.5912
72521308|NCT03363165|144571202|SUPERIORITY||Mean Difference (Final Values)|-2.0||||0.5442|ONE_SIDED|90.0|-25.47||||ANCOVA|Adjusted for baseline six-minute walk distance, age, race, former smoker.|||||-25.47|0.5442
72521309|NCT03363165|144571203|SUPERIORITY||Mean Difference (Final Values)|-0.5||||0.6603|ONE_SIDED|90.0|-2.11|||Adjusted for baseline pain-free treadmill walking time, age, race, former smoker.|ANCOVA||||||-2.11|0.6603
72521310|NCT03363165|144571204|SUPERIORITY||Mean Difference (Final Values)|-2.78||||0.5647|ONE_SIDED|90.0|-24.99||||ANCOVA|Adjusted for baseline six-minute walk distance, age, race, former smoker.|||||-24.99|0.5647
72521311|NCT02052141|144571229|SUPERIORITY||Mean difference|-0.4|STANDARD_DEVIATION|0.58||0.03|TWO_SIDED|90.0|-0.71|-0.1|||Paired t-test||The difference between treatment B over treatment A was estimated.|||-0.10|-0.71|0.03
72521312|NCT02052141|144571230|SUPERIORITY||Mean difference|-0.7|STANDARD_DEVIATION|1.06||0.05|TWO_SIDED|90.0|-1.2|-0.11|||Paired t-test||The difference between treatment B over treatment A was estimated.|||-0.11|-1.20|0.05
72521313|NCT02052141|144571231|SUPERIORITY||Mean difference|-1.9|STANDARD_DEVIATION|2.82||0.04|TWO_SIDED|90.0|-3.31|-0.38|||Paired t-test||The difference between treatment B over treatment A was estimated.|||-0.38|-3.31|0.04
72521314|NCT02052141|144571232|SUPERIORITY||Mean difference|-0.2|STANDARD_DEVIATION|0.37||0.07|TWO_SIDED|90.0|-0.41|-0.03|||Paired t-test||The difference between treatment B over treatment A was estimated|||-0.03|-0.41|0.07
72521315|NCT00291187|144571238|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-21.5|||<|0.001|TWO_SIDED|95.0|-33.1|-9.9|||ANCOVA|||||-9.9|-33.1|<0.001
72521316|NCT00291187|144571238|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-26.3|||<|0.001|TWO_SIDED|95.0|-37.8|-14.7|||ANCOVA|||||-14.7|-37.8|<0.001
72521317|NCT00291187|144571238|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-22.8|||<|0.001|TWO_SIDED|95.0|-34.2|-11.3|||ANCOVA|||||-11.3|-34.2|<0.001
72521318|NCT00291187|144571239|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-24.2||||0.017|TWO_SIDED|95.0|-44.1|-4.3|||ANCOVA|||||-4.3|-44.1|0.017
72521319|NCT00291187|144571239|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-33.7||||0.001|TWO_SIDED|95.0|-53.6|-13.9|||ANCOVA|||||-13.9|-53.6|0.001
72521320|NCT00291187|144571239|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.4||||0.081|TWO_SIDED|95.0|-37.0|2.1|||ANCOVA|||||2.1|-37.0|0.081
72521321|NCT00291187|144571240|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|33.7||||0.002|TWO_SIDED|95.0|13.0|54.5|||ANCOVA|||||54.5|13.0|0.002
72521322|NCT00291187|144571240|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|47.9|||<|0.001|TWO_SIDED|95.0|27.2|68.6|||ANCOVA|||||68.6|27.2|<0.001
72521323|NCT00291187|144571240|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|29.6||||0.005|TWO_SIDED|95.0|9.1|50.0|||ANCOVA|||||50.0|9.1|0.005
72521324|NCT00291187|144571241|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.1||||0.006|TWO_SIDED|95.0|-18.9|-3.3|||ANCOVA|||||-3.3|-18.9|0.006
72521325|NCT00291187|144571241|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.3|||<|0.001|TWO_SIDED|95.0|-22.1|-6.5|||ANCOVA|||||-6.5|-22.1|<0.001
72521326|NCT00291187|144571241|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.3||||0.002|TWO_SIDED|95.0|-20.0|-4.6|||ANCOVA|||||-4.6|-20.0|0.002
72521327|NCT03168555|144571246|EQUIVALENCE|compares visit 1 with visit 2||||||0.03|||||||Wilcoxon (Mann-Whitney)|||||||0.03
72521328|NCT03168555|144571248|EQUIVALENCE|compares visit 1 with visit 2||||||0.63|||||||paired t-test|lognormalized values||compares visit 1 with visit 2||||0.63
72521329|NCT03168555|144571249|SUPERIORITY|||||||0.32|||||||Wilcoxon (Mann-Whitney)|||||||0.32
72521330|NCT03168555|144571250|SUPERIORITY|||||||0.73|||||||Wilcoxon (Mann-Whitney)|||||||0.73
72521331|NCT03168555|144571251|OTHER|Spearman correlation||||||0.41|||||||Spearman correlation|||||||0.41
72521332|NCT03168555|144571252|OTHER|Spearman correlation||||||0.35|||||||Spearman correlation|||||||0.35
72521333|NCT03168555|144571252|OTHER|||||||0.03|||||||Spearman correlation|||||||0.03
72521334|NCT03168555|144571253|EQUIVALENCE|comparing visit 1 with visit 2||||||0.36|||||||paired t-test|||||||0.36
72521335|NCT03168555|144571254|SUPERIORITY|||||||0.29|||||||paired t-test|||||||0.29
72521336|NCT03168555|144571255|OTHER|Spearman correlation||||||0.73|||||||Spearman correlation|||||||0.73
72521337|NCT03168555|144571255|OTHER|||||||0.77|||||||Spearman correlation|||||||0.77
72521338|NCT03168555|144571256|SUPERIORITY|||||||0.8|||||||Wilcoxon (Mann-Whitney)|||||||0.80
72521339|NCT01515488|144571299|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|32.3|STANDARD_ERROR_OF_MEAN|5.2|<|0.0005|TWO_SIDED|95.0|22.1|42.6|||t-test, 2 sided|DF=331.2||||42.6|22.1|<0.0005
72521340|NCT03920865|144571355|OTHER|Descriptive statistics.|Ratio of Geometric Least Squares Means|0.802|||||TWO_SIDED|90.0|0.627|1.03||||||||1.03|0.627|
72624997|NCT03440385|144779525|SUPERIORITY||Odds Ratio (OR)|0.96||||0.8125|TWO_SIDED|95.0|0.66|1.39|||Cochran-Mantel-Haenszel|Odds ratio, and p-value are obtained using the CMH test stratified by corticosteroid use at baseline (yes or no), and prior biologic use (yes or no).||||1.39|0.66|0.8125
72624998|NCT03440385|144779526|SUPERIORITY||Odds Ratio (OR)|1.13||||0.54|TWO_SIDED|95.0|0.77|1.66|||Cochran-Mantel-Haenszel|Odds ratio, and p-value are obtained using the CMH test stratified by corticosteroid use at baseline (yes or no), and prior biologic use (yes or no).||||1.66|0.77|0.5400
72521341|NCT03920865|144571355|OTHER|Descriptive statistics.|Ratio of Geometric Least Squares Means|0.842|||||TWO_SIDED|90.0|0.588|1.21||||||||1.21|0.588|
72521342|NCT03920865|144571357|OTHER|Descriptive statistics.|Ratio of Geometric Least Squares Means|0.95|||||TWO_SIDED|90.0|0.695|1.3||||||||1.30|0.695|
72521343|NCT03920865|144571357|OTHER|Descriptive statistics.|Ratio of Geometric Least Squares Means|0.953|||||TWO_SIDED|90.0|0.715|1.27||||||||1.27|0.715|
72521344|NCT03920865|144571358|OTHER|Descriptive statistics.|Ratio of Geometric Least Squares Means|1.08|||||TWO_SIDED|90.0|0.83|1.39||||||||1.39|0.830|
72521345|NCT03920865|144571358|OTHER|Descriptive statistics.|Ratio of Geometric Least Squares Means|0.947|||||TWO_SIDED|90.0|0.74|1.21||||||||1.21|0.740|
72521346|NCT03920865|144571360|OTHER|Descriptive statistics.|Ratio of Geometric Least Squares Means|1.2|||||TWO_SIDED|90.0|0.962|1.49||||||||1.49|0.962|
72521347|NCT03920865|144571360|OTHER|Descriptive statistics.|Ratio of Geometric Least Squares Means|0.991|||||TWO_SIDED|90.0|0.81|1.21||||||||1.21|0.810|
72521348|NCT01142193|144571408|SUPERIORITY_OR_OTHER||Median Difference (Net)|17.85|||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<.001
72521349|NCT01142193|144571408|SUPERIORITY_OR_OTHER||Median Difference (Net)|18.5|||||TWO_SIDED|95.0|8.53|28.1|||Hodges-Lehmann|||||28.1|8.53|
72521350|NCT01142193|144571409|SUPERIORITY_OR_OTHER||Difference in Percentages|14.7||||0.013|||||||Fisher Exact|||||||0.013
72521351|NCT01142193|144571410|SUPERIORITY_OR_OTHER||Difference in Percentages|16.3||||0.007|||||||Cochran-Mantel-Haenszel|Analysis was stratified by Geographic Region.||||||0.007
72521352|NCT01142193|144571411|SUPERIORITY_OR_OTHER||Median Difference (Net)|25.36|||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
72521353|NCT01142193|144571412|SUPERIORITY_OR_OTHER||Median Difference (Net)|17.85|||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
72521354|NCT01142193|144571416|SUPERIORITY_OR_OTHER||Median Difference (Net)|23.61||||0.001|||||||Wilcoxon (Mann-Whitney)|||||||0.001
72521355|NCT01142193|144571417|SUPERIORITY_OR_OTHER||Difference in Percentages|13.4||||0.048|||||||Cochran-Mantel-Haenszel|Analysis was stratified by Geographic Region.||||||0.048
72521356|NCT01459068|144571418|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|We estimated 150 participants in each arm using the test for paired means, based on a moderate effect size (0.50), 80% power, two-tailed 5% significance level, design effect of 1.5, and up to a 50% expected drop-out rate (due to frequent cross-border movement).|Mean Difference (Final Values)|-0.49|STANDARD_ERROR_OF_MEAN|0.05|<|0.001|TWO_SIDED|95.0|-0.59|-0.4||a priori threshold for statistical significance was 0.05.|longitudinal model|longitudinal to model within-person change in mean scores||||-0.40|-0.59|<0.001
72521357|NCT01459068|144571419|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|power calculations were not done for secondary outcomes|Mean Difference (Net)|-0.44|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.59|-0.28|||longitudinal model|||||-0.28|-0.59|<0.001
72521358|NCT01459068|144571420|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|We estimated 150 participants in each arm using the test for paired means, based on a moderate effect size (0.50), 80% power, two-tailed 5% significance level, design effect of 1.5, and up to a 50% expected drop-out rate (due to frequent cross-border movement).|Mean Difference (Net)|-0.43|STANDARD_ERROR_OF_MEAN|0.04|<|0.001|TWO_SIDED|95.0|-0.51|-0.35||a priori threshold for significance set at 0.05|longitudinal model|longitudinal analysis modeling within-person change in mean scores||||-0.35|-0.51|<0.001
72521359|NCT01459068|144571421|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|no power calculations on secondary outcomes|Mean Difference (Net)|-0.48|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|95.0|-0.61|-0.34|||longitudinal model|||||-0.34|-0.61|<0.001
72521360|NCT01459068|144571422|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|no power calculations for secondary measures|Mean Difference (Net)|-0.24|STANDARD_ERROR_OF_MEAN|0.05|<|0.001|TWO_SIDED|95.0|-0.34|-0.15|||longitudinal model|||||-0.15|-0.34|<0.001
72521361|NCT01459068|144571423|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|no power calculations for secondary measures|Mean Difference (Net)|-0.03|STANDARD_ERROR_OF_MEAN|0.26||0.896|TWO_SIDED|95.0|-0.44|0.5|||longitudinal model|||||0.50|-0.44|0.896
72521362|NCT00701441|144571439|SUPERIORITY_OR_OTHER|||||||0.02||95.0||||For comparing pre versus post, paired t tests were used. We considered tests in the hypothesized direction conclusive|t-test, 2 sided|For each comparison, we tested at the 0.05 level with double-sided P values. We used no correction for multiple testing when declaring significance.||Flow mediated dilation = \[(average maximum dilation post cuff deflation - average baseline diameter)/ average baseline diameter\]100||||0.02
72521363|NCT00701441|144571440|SUPERIORITY_OR_OTHER|||||||0.02||95.0||||We only consider tests in the hypothesized direction conclusive, so testing is conservative from that perspective. However, we used no correction for multiple testing when declaring significance|t-test, 2 sided|||For comparing pre- versus post-treatment, paired t tests were used. For each variable and comparison, we tested at the 0.05 level with double-sided P values.||||0.02
72521364|NCT01015820|144571441|SUPERIORITY_OR_OTHER|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||Statistical significance p ≤ 0.05||||0.001
72521365|NCT01015820|144571442|SUPERIORITY_OR_OTHER|||||||0.03|||||||Wilcoxon (Mann-Whitney)|||Statistical significance p ≤ 0.05||||0.03
72624999|NCT03440385|144779527|SUPERIORITY||Odds Ratio (OR)|1.28||||0.2411|TWO_SIDED|95.0|0.85|1.95|||Cochran-Mantel-Haenszel|Odds ratio, and p-value are obtained using the CMH test stratified by corticosteroid use at baseline (yes or no), and prior biologic use (yes or no).||||1.95|0.85|0.2411
72625000|NCT03440385|144779528|SUPERIORITY||Odds Ratio (OR)|0.94||||0.7469|TWO_SIDED|95.0|0.67|1.34|||Cochran-Mantel-Haenszel|Odds ratio, and p-value are obtained using the CMH test stratified by corticosteroid use at baseline (yes or no), and prior biologic use (yes or no).||||1.34|0.67|0.7469
72625001|NCT03440385|144779529|SUPERIORITY||Odds Ratio (OR)|1.22||||0.4255|TWO_SIDED|95.0|0.75|1.97|||Cochran-Mantel-Haenszel|Odds ratio, and p-value are obtained using the CMH test stratified by corticosteroid use at baseline (yes or no), and prior biologic use (yes or no).||||1.97|0.75|0.4255
72521366|NCT01041404|144571475|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.71||||0.0002|TWO_SIDED|95.0|0.59|0.85|||Log Rank|||||0.85|0.59|0.0002
72521367|NCT01041404|144571477|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.7||||0.0003|TWO_SIDED|95.0|0.58|0.85|||Log Rank|||||0.85|0.58|0.0003
72521368|NCT01041404|144571478|SUPERIORITY_OR_OTHER||Difference in Response Rates|12.8||||0.0017|TWO_SIDED|95.0|4.7|20.9|||Chi-squared|||||20.9|4.7|0.0017
72521369|NCT01041404|144571480|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.54|||<|0.0001|TWO_SIDED|95.0|0.4|0.73|||Log Rank|||||0.73|0.40|<0.0001
72521370|NCT01041404|144571481|SUPERIORITY_OR_OTHER||Difference in Clinical Benefit Rate|9.6||||0.0081|TWO_SIDED|95.0|2.4|16.9|||Chi-squared|||||16.9|2.4|0.0081
72521371|NCT01041404|144571481|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.66|||||TWO_SIDED|95.0|1.14|2.41||||||||2.41|1.14|
72521372|NCT01041404|144571482|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.74||||0.0046|TWO_SIDED|95.0|0.6|0.91|||Log Rank|||||0.91|0.60|0.0046
72569888|NCT02504671|144670130|OTHER||Mean Difference (Net)|-12.63||||0.015|TWO_SIDED|95.0|-22.78|-2.48||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||PtGA, Week 12|||-2.48|-22.78|0.015
72569889|NCT02504671|144670130|OTHER||Mean Difference (Net)|-17.18|||<|0.001|TWO_SIDED|95.0|-27.27|-7.1||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||PtGA, Week 12|||-7.10|-27.27|<0.001
72569890|NCT02504671|144670130|OTHER||Mean Difference (Net)|-2.98||||0.054|TWO_SIDED|95.0|-6.0|0.05||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||SJC28, Week 12|||0.05|-6.00|0.054
72569891|NCT02504671|144670130|OTHER||Mean Difference (Net)|-6.04|||<|0.001|TWO_SIDED|95.0|-9.05|-3.02||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||SJC28, Week 12|||-3.02|-9.05|<0.001
72569892|NCT02504671|144670130|OTHER||Mean Difference (Net)|-3.63||||0.031|TWO_SIDED|95.0|-6.92|-0.33||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||TJC28, Week 12|||-0.33|-6.92|0.031
72569893|NCT02504671|144670130|OTHER||Mean Difference (Net)|-6.32|||<|0.001|TWO_SIDED|95.0|-9.61|-3.02||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||TJC28, Week 12|||-3.02|-9.61|<0.001
72569894|NCT02504671|144670131|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||Week 4. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
72521373|NCT01685203|144571494|SUPERIORITY_OR_OTHER_LEGACY|||||||0.381|TWO_SIDED||||||Regression, Logistic|Treatment group, baseline log(subscript)10(subscript) HCV RNA level and Interleukin-28B (IL28B) genotype (CC or non-CC) were used as predictors||||||0.381
72521374|NCT01685203|144571494|SUPERIORITY_OR_OTHER_LEGACY|||||||0.086|TWO_SIDED|||||Difference in rates after adjusting for Interleukin-28 (IL28) genotype (CC or Non-CC) using stratum-adjusted Mantel-Haenszel proportions and continuity-corrected variances.|Stratum-adjusted Mantel-Haenszel|||||||0.086
72521375|NCT00383708|144571498|OTHER||||||<|0.0001|||||||Exact test|One-sided p value||The percentage of subjects (denoted as pnor) was compared to the minimum clinically relevant (theoretical) percentage of 30%, using an exact test based on the binomial distribution. The test was an upper-tailed test of H0: pnor ≤ 0.3 versus H1: pnor \> 0.3.||||<0.0001
72569895|NCT02504671|144670131|OTHER||Difference|0.0|||||TWO_SIDED|95.0|-10.3|10.3|||||Week 6. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||10.3|-10.3|
72569896|NCT02504671|144670131|OTHER||Difference|-5.4|||||TWO_SIDED|95.0|-12.7|1.9|||||Week 6. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||1.9|-12.7|
72569897|NCT02504671|144670131|OTHER||Difference|0.0|||||TWO_SIDED|95.0|-10.3|10.3|||||Week 6. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||10.3|-10.3|
72569898|NCT02504671|144670131|OTHER||Difference|-2.7|||||TWO_SIDED|95.0|-7.9|2.5|||||Week 8. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||2.5|-7.9|
72569899|NCT02504671|144670131|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-6.3|11.7|||||Week 8. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||11.7|-6.3|
72569900|NCT02504671|144670131|OTHER||Difference|10.8|||||TWO_SIDED|95.0|-1.4|23.0|||||Week 8. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||23.0|-1.4|
72569901|NCT02504671|144670131|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-4.8|15.6|||||Week 12. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||15.6|-4.8|
72569902|NCT02504671|144670131|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-6.3|11.7|||||Week 12. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||11.7|-6.3|
72569903|NCT02504671|144670131|OTHER||Difference|21.6|||||TWO_SIDED|95.0|6.8|36.4|||||Week 12. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||36.4|6.8|
72569904|NCT02504671|144670131|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||Week 16. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
72569905|NCT02504671|144670131|OTHER||Difference|13.5|||||TWO_SIDED|95.0|2.5|24.5|||||Week 16. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||24.5|2.5|
72569906|NCT02504671|144670131|OTHER||Difference|27.0|||||TWO_SIDED|95.0|12.7|41.3|||||Week 16. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||41.3|12.7|
72521376|NCT00383708|144571499|OTHER|||||||0.1654||||||One-sided p value|Exact test|||The percentage of subjects in the subgroup previously treated with pegvisomant (denoted as pnor) was compared to the minimum clinically relevant (theoretical) percentage of 30%, using an exact test based on the binomial distribution. The test was an upper-tailed test of H0: pnor ≤ 0.3 versus H1: pnor \> 0.3.||||0.1654
72521377|NCT00383708|144571499|OTHER|||||||0.0115||||||One-sided p value|Exact test|||The percentage of subjects in the subgroup previously treated with lanreotide Autogel (denoted as pnor) was compared to the minimum clinically relevant (theoretical) percentage of 30%, using an exact test based on the binomial distribution. The test was an upper-tailed test of H0: pnor ≤ 0.3 versus H1: pnor \> 0.3.||||0.0115
72521378|NCT00383708|144571499|OTHER|||||||0.0003||||||One-sided p value|Exact test|||The percentage of subjects in the subgroup previously treated with octreotide LAR (denoted as pnor) was compared to the minimum clinically relevant (theoretical) percentage of 30%, using an exact test based on the binomial distribution. The test was an upper-tailed test of H0: pnor ≤ 0.3 versus H1: pnor \> 0.3.||||0.0003
72521379|NCT00383708|144571500|OTHER|||||||0.084||||||One-sided p value|Exact test|||The percentage of subjects in the subgroup diabetic subjects (denoted as pnor) was compared to the minimum clinically relevant (theoretical) percentage of 30%, using an exact test based on the binomial distribution. The test was an upper-tailed test of H0: pnor ≤ 0.3 versus H1: pnor \> 0.3.||||0.084
72521380|NCT00383708|144571500|OTHER||||||<|0.0001||||||One-sided p value|Exact test|||The percentage of subjects in the subgroup non diabetic subjects (denoted as pnor) was compared to the minimum clinically relevant (theoretical) percentage of 30%, using an exact test based on the binomial distribution. The test was an upper-tailed test of H0: pnor ≤ 0.3 versus H1: pnor \> 0.3.||||<0.0001
72521381|NCT00383708|144571501|OTHER||||||<|0.0001||||||One-sided p-value|Exact test|||The percentage of subjects in the subgroup 'while taking final dose during co-administration' (denoted as pnor) was compared to the minimum clinically relevant (theoretical) percentage of 30%, using an exact test based on the binomial distribution. The test was an upper-tailed test of H0: pnor ≤ 0.3 versus H1: pnor \> 0.3.||||<0.0001
72521382|NCT00383708|144571501|OTHER||||||<|0.0001||||||One-sided p-value|Exact test|||The percentage of subjects in the subgroup 'at any time during co-administration' (denoted as pnor) was compared to the minimum clinically relevant (theoretical) percentage of 30%, using an exact test based on the binomial distribution. The test was an upper-tailed test of H0: pnor ≤ 0.3 versus H1: pnor \> 0.3.||||<0.0001
72369310|NCT00611026|144248568|SUPERIORITY_OR_OTHER|||||||0.0169|TWO_SIDED||||||Cochran-Mantel-Haenszel|P-value based on Cochran-Mantel-Haenszel test stratified by baseline UUI quartile.||Treatment difference in continent rate for fesoterodine vs Tolterodine ER at Week 12.||||0.0169
72369311|NCT00611026|144248569|SUPERIORITY_OR_OTHER|||||||0.0009|TWO_SIDED||||||Cochran-Mantel-Haenszel|P-value was obtained from a Cochran-Mantel-Haenszel test (CMH) with modified ridit scoring and stratified by country.||Treatment difference fesoterodine vs placebo at Week 1.||||0.0009
72369312|NCT00611026|144248569|SUPERIORITY_OR_OTHER|||||||0.0279|TWO_SIDED||||||Cochran-Mantel-Haenszel|P-value was obtained from a Cochran-Mantel-Haenszel test (CMH) with modified ridit scoring and stratified by country.||Treatment difference Tolterodine ER vs placebo at Week 1.||||0.0279
72369313|NCT00611026|144248569|SUPERIORITY_OR_OTHER|||||||0.2817|TWO_SIDED||||||Cochran-Mantel-Haenszel|P-value was obtained from a Cochran-Mantel-Haenszel test (CMH) with modified ridit scoring and stratified by country.||Treatment difference Tolterodine ER vs Fesoterodine at Week 1.||||0.2817
72369314|NCT00611026|144248569|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|P-value was obtained from a Cochran-Mantel-Haenszel test (CMH) with modified ridit scoring and stratified by country.||Treatment difference fesoterodine vs placebo at Week 4.||||<0.0001
72521383|NCT01576406|144571540|SUPERIORITY||Geometric mean ratio|91.2|||||TWO_SIDED|90.0|57.47|144.72||||||Confidence interval (CI): Geometric mean ratio and 90 percent (%) CI were derived from analysis of variance (ANOVA) model.||144.72|57.47|
72521384|NCT01576406|144571540|SUPERIORITY||Geometric mean ratio|143.82|||||TWO_SIDED|90.0|89.11|232.12||||||CI: Geometric mean ratio and 90% CI were derived from ANOVA model.||232.12|89.11|
72521385|NCT01576406|144571540|SUPERIORITY||Geometric mean ratio|108.87|||||TWO_SIDED|90.0|70.13|168.99||||||CI: Geometric mean ratio and 90% CI were derived from ANOVA model.||168.99|70.13|
72521386|NCT01576406|144571540|SUPERIORITY||Geometric mean ratio|72.63|||||TWO_SIDED|90.0|49.07|107.5||||||CI: Geometric mean ratio and 90% CI were derived from ANOVA model.||107.50|49.07|
72521387|NCT01576406|144571566|SUPERIORITY||Percentage of ratio of geometric mean|91.12|||||TWO_SIDED|90.0|56.56|146.79||||||CI: Geometric mean ratio and 90% CI were derived from ANOVA model.||146.79|56.56|
72521388|NCT01576406|144571566|SUPERIORITY||Percentage of ratio of geometric mean|149.54|||||TWO_SIDED|90.0|91.85|243.46||||||CI: Geometric mean ratio and 90% CI were derived from ANOVA model.||243.46|91.85|
72521389|NCT01576406|144571566|SUPERIORITY||Percentage of ratio of geometric mean|114.08|||||TWO_SIDED|90.0|73.57|176.89||||||CI: Geometric mean ratio and 90% CI were derived from ANOVA model.||176.89|73.57|
72521390|NCT01576406|144571566|SUPERIORITY||Percentage of ratio of geometric mean|64.67|||||TWO_SIDED|90.0|39.5|105.89||||||CI: Geometric mean ratio and 90% CI were derived from ANOVA model.||105.89|39.50|
72569907|NCT02504671|144670131|OTHER||Difference|-2.7|||||TWO_SIDED|95.0|-7.9|2.5|||||Week 20. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||2.5|-7.9|
72569908|NCT02504671|144670131|OTHER||Difference|13.5|||||TWO_SIDED|95.0|0.5|26.5|||||Week 20. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||26.5|0.5|
72569909|NCT02504671|144670131|OTHER||Difference|16.2|||||TWO_SIDED|95.0|2.6|29.9|||||Week 20. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||29.9|2.6|
72569910|NCT02504671|144670131|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-6.3|11.7|||||Week 24. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||11.7|-6.3|
72569911|NCT02504671|144670131|OTHER||Difference|13.5|||||TWO_SIDED|95.0|0.5|26.5|||||Week 24. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||26.5|0.5|
72569912|NCT02504671|144670131|OTHER||Difference|16.2|||||TWO_SIDED|95.0|2.6|29.9|||||Week 24. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||29.9|2.6|
72521391|NCT01576406|144571567|SUPERIORITY||Percentage of ratio of geometric mean|108.43|||||TWO_SIDED|90.0|63.47|185.26||||||CI: Geometric mean ratio and 90% CI were derived from ANOVA model.||185.26|63.47|
72521392|NCT01576406|144571567|SUPERIORITY||Percentage of ratio of geometric mean|202.89|||||TWO_SIDED|90.0|120.96|340.3||||||CI: Geometric mean ratio and 90% CI were derived from ANOVA model.||340.30|120.96|
72521393|NCT01576406|144571567|SUPERIORITY||Percentage of ratio of geometric mean|130.78|||||TWO_SIDED|90.0|86.61|197.47||||||CI: Geometric mean ratio and 90% CI were derived from ANOVA model.||197.47|86.61|
72521394|NCT01576406|144571567|SUPERIORITY||Percentage of ratio of geometric mean|62.82|||||TWO_SIDED|90.0|42.54|92.78||||||CI: Geometric mean ratio and 90% CI were derived from ANOVA model.||92.78|42.54|
72521395|NCT03906136|144571580|SUPERIORITY||Odds Ratio (OR)|0.69||||0.119|TWO_SIDED|95.0|0.43|1.1|||Regression, Logistic|||Week 24||1.10|0.43|0.119
72521396|NCT03906136|144571581|SUPERIORITY||Odds Ratio (OR)|0.59||||0.029|TWO_SIDED|95.0|0.37|0.95|||Regression, Logistic|||Week 12||0.95|0.37|0.029
72521397|NCT03906136|144571582|SUPERIORITY||Odds Ratio (OR)|0.71||||0.154|TWO_SIDED|95.0|0.45|1.14|||Regression, Logistic|||Week 12||1.14|0.45|0.154
72521398|NCT03906136|144571582|SUPERIORITY||Odds Ratio (OR)|0.87||||0.562|TWO_SIDED|95.0|0.54|1.39|||Regression, Logistic|||Week 24||1.39|0.54|0.562
72521399|NCT03906136|144571583|SUPERIORITY||Odds Ratio (OR)|0.55||||0.029|TWO_SIDED|95.0|0.32|0.94|||Regression, Logistic|||Week 12||0.94|0.32|0.029
72521400|NCT03906136|144571583|SUPERIORITY||Odds Ratio (OR)|0.74||||0.264|TWO_SIDED|95.0|0.44|1.25|||Regression, Logistic|||Week 24||1.25|0.44|0.264
72521401|NCT03906136|144571584|SUPERIORITY||Odds Ratio (OR)|0.49||||0.008|TWO_SIDED|95.0|0.29|0.83|||Regression, Logistic|||Week 12||0.83|0.29|0.008
72521402|NCT03906136|144571584|SUPERIORITY||Odds Ratio (OR)|0.47||||0.005|TWO_SIDED|95.0|0.28|0.8|||Regression, Logistic|||Week 24||0.80|0.28|0.005
72521403|NCT03906136|144571585|SUPERIORITY||Odds Ratio (OR)|0.72||||0.263|TWO_SIDED|95.0|0.4|1.28|||Regression, Logistic|||Week 12||1.28|0.40|0.263
72521404|NCT03906136|144571585|SUPERIORITY||Odds Ratio (OR)|0.61||||0.103|TWO_SIDED|95.0|0.34|1.1|||Regression, Logistic|||Week 24||1.10|0.34|0.103
72569913|NCT02504671|144670131|OTHER||Difference|0.0|||||TWO_SIDED|95.0|-7.4|7.4|||||Week 28. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.4|-7.4|
72569914|NCT02504671|144670131|OTHER||Difference|13.5|||||TWO_SIDED|95.0|0.5|26.5|||||Week 28. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||26.5|0.5|
72569915|NCT02504671|144670131|OTHER||Difference|13.5|||||TWO_SIDED|95.0|0.5|26.5|||||Week 28. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||26.5|0.5|
72569916|NCT02504671|144670131|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-6.3|11.7|||||Week 32. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||11.7|-6.3|
72569917|NCT02504671|144670131|OTHER||Difference|18.9|||||TWO_SIDED|95.0|4.7|33.2|||||Week 32. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||33.2|4.7|
72569918|NCT02504671|144670131|OTHER||Difference|10.8|||||TWO_SIDED|95.0|-1.4|23.0|||||Week 32. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||23.0|-1.4|
72569919|NCT02504671|144670131|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-6.3|11.7|||||Week 36. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||11.7|-6.3|
72569920|NCT02504671|144670131|OTHER||Difference|16.2|||||TWO_SIDED|95.0|2.6|29.9|||||Week 36. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||29.9|2.6|
72569921|NCT02504671|144670131|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-4.8|15.6|||||Week 36. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||15.6|-4.8|
72569922|NCT02504671|144670131|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||Week 40. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
72405940|NCT04074317|144320322|EQUIVALENCE|"Bioequivalence would require the 90% confidence intervals of the geometric mean ratio to be contained within the 80 - 125% range.~H0: Means are equal between treatment groups. Ha: Means are not equal across the treatment groups."|Ratio of geometric least-squares means|131.55||||0.0026|TWO_SIDED|90.0|116.01|149.17||Bonferroni-adjusted p-value to maintain the overall Type 1 error rate at 0.05.|ANOVA||"Ratio calculated as Regular Insulin geometric least-squares mean divided by the Regular Insulin + Pramlintide geometric least-squares mean, expressed as a percentage.~Confidence interval on the ratio, expressed as a percentage."|AUC 0 to 180 The statistical model was an analysis of variance (ANOVA) on the ln-transformed data with sequence, period, and treatment as fixed effect and subject nested within sequence as a random effect.||149.17|116.01|0.0026
72405941|NCT04074317|144320322|EQUIVALENCE|"Bioequivalence would require the 90% confidence intervals of the geometric mean ratio to be contained within the 80 - 125% range.~H0: Means are equal between treatment groups. Ha: Means are not equal across the treatment groups."|Ratio of geometric least-squares means|51.34|||<|0.0001|TWO_SIDED|90.0|46.74|56.39||Bonferroni-adjusted p-value to maintain the overall Type 1 error rate at 0.05.|ANOVA||"Ratio calculated as PRAM geometric least-squares mean divided by the Regular Insulin geometric least-squares mean, expressed as a percentage.~Confidence interval on the ratio, expressed as a percentage."|AUC 0 to 360 The statistical model was an analysis of variance (ANOVA) on the ln-transformed data with sequence, period, and treatment as fixed effect and subject nested within sequence as a random effect.||56.39|46.74|<0.0001
72405942|NCT04074317|144320322|EQUIVALENCE|"Bioequivalence would require the 90% confidence intervals of the geometric mean ratio to be contained within the 80 - 125% range.~H0: Means are equal between treatment groups. Ha: Means are not equal across the treatment groups."|Ratio of geometric least-squares means|78.24||||0.0003|TWO_SIDED|90.0|71.39|85.76||Bonferroni-adjusted p-value to maintain the overall Type 1 error rate at 0.05.|ANOVA||"Ratio calculated as PRAM geometric least-squares mean divided by the Regular Insulin + Pramlintide geometric least-squares mean, expressed as a percentage.~Confidence interval on the ratio, expressed as a percentage."|AUC 0 to 360 The statistical model was an analysis of variance (ANOVA) on the ln-transformed data with sequence, period, and treatment as fixed effect and subject nested within sequence as a random effect.||85.76|71.39|0.0003
72405943|NCT04074317|144320322|EQUIVALENCE|"Bioequivalence would require the 90% confidence intervals of the geometric mean ratio to be contained within the 80 - 125% range.~H0: Means are equal between treatment groups. Ha: Means are not equal across the treatment groups."|Ratio of geometric least-squares means|152.41|||<|0.0001|TWO_SIDED|90.0|138.91|167.22||Bonferroni-adjusted p-value to maintain the overall Type 1 error rate at 0.05.|ANOVA||"Ratio calculated as Regular Insulin geometric least-squares mean divided by the Regular Insulin + Pramlintide geometric least-squares mean, expressed as a percentage.~Confidence interval on the ratio, expressed as a percentage."|AUC 0 to 360 The statistical model was an analysis of variance (ANOVA) on the ln-transformed data with sequence, period, and treatment as fixed effect and subject nested within sequence as a random effect.||167.22|138.91|<0.0001
72405944|NCT03548584|144320323|SUPERIORITY||LS Mean Difference|-5.32||||0.0026|TWO_SIDED|95.0|-8.77|-1.87||MMRM method with model terms of treatment, trial site, visit, treatment-by-visit and baseline-by-visit interaction were used for analysis.|MMRM|||||-1.87|-8.77|0.0026
72405945|NCT03548584|144320324|SUPERIORITY||LS Mean Difference|-0.27||||0.0078|TWO_SIDED|95.0|-0.47|-0.07||MMRM method with model terms of treatment, trial site, visit, treatment-by-visit and baseline-by-visit interaction were used for analysis.|MMRM|||||-0.07|-0.47|0.0078
72405946|NCT03548584|144320325|SUPERIORITY||LS Mean Difference|-1.95||||0.004|TWO_SIDED|95.0|-3.28|-0.63||MMRM method with model terms of treatment, trial site, visit, treatment-by-visit and baseline-by-visit interaction were used for analysis.|MMRM|||Aggressive Behavior||-0.63|-3.28|0.0040
72405947|NCT03548584|144320325|SUPERIORITY||LS Mean Difference|-1.41||||0.0296|TWO_SIDED|95.0|-2.68|-0.14||MMRM method with model terms of treatment, trial site, visit, treatment-by-visit and baseline-by-visit interaction were used for analysis.|MMRM|||Physically Nonaggressive Behavior||-0.14|-2.68|0.0296
72569923|NCT02504671|144670131|OTHER||Difference|13.5|||||TWO_SIDED|95.0|2.5|24.5|||||Week 40. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||24.5|2.5|
72521405|NCT03906136|144571586|SUPERIORITY||Odds Ratio (OR)|0.64||||0.055|TWO_SIDED|95.0|0.4|1.01|||Regression, Logistic|||Week 12||1.01|0.40|0.055
72569924|NCT02504671|144670131|OTHER||Difference|13.5|||||TWO_SIDED|95.0|2.5|24.5|||||Week 40. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||24.5|2.5|
72405948|NCT03548584|144320325|SUPERIORITY||LS Mean Difference|-1.24||||0.0113|TWO_SIDED|95.0|-2.21|-0.28||MMRM method with model terms of treatment, trial site, visit, treatment-by-visit and baseline-by-visit interaction were used for analysis.|MMRM|||Verbally Agitated Behavior||-0.28|-2.21|0.0113
72521406|NCT03906136|144571586|SUPERIORITY||Odds Ratio (OR)|0.82||||0.409|TWO_SIDED|95.0|0.52|1.31|||Regression, Logistic|||Week 24||1.31|0.52|0.409
72521407|NCT03906136|144571587|SUPERIORITY||Odds Ratio (OR)|0.85||||0.477|TWO_SIDED|95.0|0.53|1.34|||Regression, Logistic|||Week 12||1.34|0.53|0.477
72625002|NCT03440385|144779530|SUPERIORITY||Odds Ratio (OR)|1.02||||0.9313|TWO_SIDED|95.0|0.6|1.76|||Cochran-Mantel-Haenszel|Odds ratio, and p-value are obtained using the CMH test stratified by corticosteroid use at baseline (yes or no), and prior biologic use (yes or no).||||1.76|0.60|0.9313
72521408|NCT03906136|144571587|SUPERIORITY||Odds Ratio (OR)|1.01||||0.968|TWO_SIDED|95.0|0.63|1.61|||Regression, Logistic|||Week 24||1.61|0.63|0.968
72521409|NCT03906136|144571588|SUPERIORITY||Odds Ratio (OR)|0.3||||0.205|TWO_SIDED|95.0|-0.16|0.75|||Regression, Logistic|||Week 12||0.75|-0.16|0.205
72521410|NCT03906136|144571588|SUPERIORITY||Odds Ratio (OR)|0.37||||0.108|TWO_SIDED|95.0|-0.08|0.82|||Regression, Logistic|||Week 24||0.82|-0.08|0.108
72521411|NCT03906136|144571589|SUPERIORITY||Mean Difference (Net)|0.06||||0.525|TWO_SIDED|95.0|-0.12|0.23|||Mixed Models Analysis|||Week 12||0.23|-0.12|0.525
72569925|NCT02504671|144670131|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-6.3|11.7|||||Week 44. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||11.7|-6.3|
72569926|NCT02504671|144670131|OTHER||Difference|10.8|||||TWO_SIDED|95.0|-1.4|23.0|||||Week 44. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||23.0|-1.4|
72569927|NCT02504671|144670131|OTHER||Difference|13.5|||||TWO_SIDED|95.0|0.5|26.5|||||Week 44. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||26.5|0.5|
72569928|NCT02504671|144670131|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||Week 48. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
72569929|NCT02504671|144670131|OTHER||Difference|13.5|||||TWO_SIDED|95.0|2.5|24.5|||||Week 48. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||24.5|2.5|
72569930|NCT02504671|144670131|OTHER||Difference|13.5|||||TWO_SIDED|95.0|2.5|24.5|||||Week 48. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||24.5|2.5|
72569931|NCT02504671|144670131|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-6.3|11.7|||||Week 52. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||11.7|-6.3|
72569932|NCT02504671|144670131|OTHER||Difference|10.8|||||TWO_SIDED|95.0|-1.4|23.0|||||Week 52. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||23.0|-1.4|
72569933|NCT02504671|144670131|OTHER||Difference|8.1|||||TWO_SIDED|95.0|-3.2|19.4|||||Week 52. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||19.4|-3.2|
72569934|NCT02504671|144670131|OTHER||Difference|-2.7|||||TWO_SIDED|95.0|-7.9|2.5|||||Week 62 (follow-up). 95% CI were constructed using asymptotic Wald confidence limits without correction.|||2.5|-7.9|
72569935|NCT02504671|144670131|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-4.8|15.6|||||Week 62 (follow-up). 95% CI were constructed using asymptotic Wald confidence limits without correction.|||15.6|-4.8|
72405949|NCT03548584|144320325|SUPERIORITY||LS Mean Difference|-0.36||||0.1941|TWO_SIDED|95.0|-0.9|0.18||MMRM method with model terms of treatment, trial site, visit, treatment-by-visit and baseline-by-visit interaction were used for analysis.|MMRM|||Hiding and Hoarding||0.18|-0.90|0.1941
72569936|NCT02504671|144670131|OTHER||Difference|0.0|||||TWO_SIDED|95.0|-7.4|7.4|||||Week 62 (follow-up). 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.4|-7.4|
72569937|NCT02504671|144670131|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||Week 2. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
72521412|NCT03906136|144571589|SUPERIORITY||Mean Difference (Net)|-0.06||||0.577|TWO_SIDED|95.0|-0.25|0.14|||Mixed Models Analysis|||Week 24||0.14|-0.25|0.577
72521413|NCT03906136|144571590|SUPERIORITY||Odds Ratio (OR)|-0.89||||0.22|TWO_SIDED|95.0|-2.32|0.54|||Mixed Models Analysis|||Week 12||0.54|-2.32|0.220
72521414|NCT03906136|144571590|SUPERIORITY||Median Difference (Net)|-0.1||||0.745|TWO_SIDED|95.0|-0.7|0.5|||Regression, Logistic|||Week 24||0.50|-0.70|0.745
72521415|NCT03906136|144571591|SUPERIORITY||Mean Difference (Net)|-0.13||||0.768|TWO_SIDED|95.0|-1.01|0.74|||Mixed Models Analysis|||Week 12||0.74|-1.01|0.768
72521416|NCT03906136|144571591|SUPERIORITY||Mean Difference (Net)|-0.37||||0.451|TWO_SIDED|95.0|-1.34|0.6|||Mixed Models Analysis|||Week 24||0.60|-1.34|0.451
72521417|NCT03906136|144571592|SUPERIORITY||Mean Difference (Net)|0.26||||0.477|TWO_SIDED|95.0|-0.46|0.97|||Mixed Models Analysis|||Week 12||0.97|-0.46|0.477
72521418|NCT03906136|144571592|SUPERIORITY||Mean Difference (Net)|-0.17||||0.66|TWO_SIDED|95.0|-0.92|0.58|||Mixed Models Analysis|||Week 24||0.58|-0.92|0.660
72521419|NCT03906136|144571593|SUPERIORITY||Mean Difference (Net)|0.17||||0.586|TWO_SIDED|95.0|-0.45|0.79|||Mixed Models Analysis|||Week 12||0.79|-0.45|0.586
72521420|NCT03906136|144571593|SUPERIORITY||Median Difference (Net)|0.21||||0.491|TWO_SIDED|95.0|-0.39|0.82|||Mixed Models Analysis|||Week 24||0.82|-0.39|0.491
72521421|NCT03906136|144571594|SUPERIORITY|Week 12|Mean Difference (Net)|4.49||||0.082|TWO_SIDED|95.0|-0.58|9.56|||Mixed Models Analysis|||||9.56|-0.58|0.082
72521422|NCT03906136|144571594|SUPERIORITY||Median Difference (Net)|2.73||||0.292|TWO_SIDED|95.0|-2.35|7.81|||Mixed Models Analysis|||Week 24||7.81|-2.35|0.292
72521423|NCT00446641|144571595|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.82||||0.654||95.0|||||Chi-squared|||We assumed that the prevalence of AR would be 12 % among ischemic stroke patients who were treated with aspirin 100 per day. The prevalence could be reduced to 4% with additional cilostazol therapy||||0.654
72521424|NCT02971007|144571644|OTHER|Statistical analyses primarily descriptive with no formal statistical hypothesis testing. Summary statistics are presented by treatment group. For continuous variables, the number of observations, mean, standard deviation, median, minimum and maximum are provided as summary statistics.||||||||||||||||No formal sample size calculations were made. The sample size was determined empirically rather than with a specific statistical rationale and is considered sufficient to achieve the study objectives of this proof of concept study. Women with moderate to severe Vulvovaginal candidiasis were randomized in a 1:1:1 ratio to 1 of 3 treatment groups, stratified by signs and symptoms composite score of up to 12 (moderate) and greater than 13 (severe).|Statistical analyses primarily descriptive with no formal statistical hypothesis testing. Summary statistics are presented by treatment group. For continuous variables, the number of observations, mean, standard deviation, median, minimum and maximum are provided as summary statistics.|||
72521425|NCT02009930|144571667|OTHER||Wilson Method used|16.0|||||TWO_SIDED|95.0|9.4|22.9||||||||22.9|9.4|
72521426|NCT02009930|144571668|OTHER||||||||||||||||||Only descriptive statistics were calculated (frequency, percent). Inferential statistics were not necessary, nor appropriate|||
72521427|NCT02009930|144571669|OTHER|||||||0.79||||||Correlation between FRS and CAC risk categories in participants with at least 1 additional risk factor expressed as a p-value|Spearman's Rank Correlation Coefficient|Correlation between FRS and CAC risk categories in participants with at least 1 additional risk factor. Spearman's rho = 0.04||Compare risk categories (FRS and CAC)||||0.79
72521428|NCT02009930|144571670|OTHER|||||||0.063||||||Relationship between FRS and metabolic syndrome. FRS risk category (low, mod, mod-high, high, very high risk) and metabolic syndrome (presence/absence of metabolic syndrome)|Fisher Exact|Relationship between 2 variables (FRS - each risk category, metabolic syndrome - presence/absence) expressed as a p-value||FRS risk category (low, mod, mod-high, high, very high risk)||||0.063
72521429|NCT02009930|144571670|OTHER|||||||0.21||||||Relationship between CAC and metabolic syndrome. CAC risk category (low, low-mod, mod-high, high, very high risk) and metabolic syndrome (presence/absence of metabolic syndrome)|Fisher Exact|Relationship between 2 variables (CAC - each risk category, metabolic syndrome - presence/absence) expressed as a p-value||CAC risk category (low, low-mod, mod-high, high, very high)||||0.21
72521430|NCT02009930|144571671|OTHER|||||||0.56||||||Relationship between FRS and living in the dorms. FRS risk category (low, mod, mod-high, high, very high risk) and living in the dorms (\< 5 years, \> 5 years)|Fisher Exact|Relationship between 2 variables (FRS - each risk category, living in the dorms - \<5 years/\> 5 years) expressed as a p-value||FRS risk categories (low, moderate, mod -high, high, and very high)||||0.56
72405950|NCT03548584|144320326|SUPERIORITY||LS Mean Difference|0.85||||0.4242|TWO_SIDED|95.0|-1.24|2.93||MMRM method with model terms of treatment, trial site, visit, treatment-by-visit and baseline-by-visit interaction were used for analysis.|MMRM|||Change From Baseline at Week 2||2.93|-1.24|0.4242
72405951|NCT03548584|144320326|SUPERIORITY||LS Mean Difference|-1.14||||0.3665|TWO_SIDED|95.0|-3.63|1.34||MMRM method with model terms of treatment, trial site, visit, treatment-by-visit and baseline-by-visit interaction were used for analysis.|MMRM|||Change From Baseline at Week 4||1.34|-3.63|0.3665
72405952|NCT03548584|144320326|SUPERIORITY||LS Mean Difference|-2.32||||0.1065|TWO_SIDED|95.0|-5.15|0.5||MMRM method with model terms of treatment, trial site, visit, treatment-by-visit and baseline-by-visit interaction were used for analysis.|MMRM|||Change from Baseline at Week 6||0.50|-5.15|0.1065
72405953|NCT03548584|144320326|SUPERIORITY||LS Mean Difference|-5.08||||0.0011|TWO_SIDED|95.0|-8.12|-2.05||MMRM method with model terms of treatment, trial site, visit, treatment-by-visit and baseline-by-visit interaction were used for analysis.|MMRM|||Change from Baseline at Week 8||-2.05|-8.12|0.0011
72405954|NCT03548584|144320326|SUPERIORITY||LS Mean Difference|-6.47|||<|0.0001|TWO_SIDED|95.0|-9.54|-3.4||MMRM method with model terms of treatment, trial site, visit, treatment-by-visit and baseline-by-visit interaction were used for analysis.|MMRM|||Change from Baseline at Week 10||-3.40|-9.54|<.0001
72521431|NCT02009930|144571671|OTHER|||||||0.13||||||Relationship between CAC and living in the dorms. CAC risk category (low, low-mod, mod-high, high, very high risk) and living in the dorms (\< 5 years, \> 5 years)|Fisher Exact|Relationship between 2 variables (CAC - each risk category, living in the dorms - \<5 years/\> 5 years) expressed as a p-value||CAC risk category (low, low-mod, moderate - high, high, and very high)||||0.13
72521432|NCT02009930|144571672|OTHER|||||||0.44||||||Relationship between FRS and PT failures. FRS risk category (low, mod, mod-high, high, very high risk) and PT failures (with, without PT failure)|Fisher Exact|Relationship between 2 variables (FRS - each risk category, PT failure - with/without PT failure) expressed as a p-value||FRS risk categories (low, moderate, moderate-high, high, and very high)||||0.44
72521433|NCT02009930|144571672|OTHER|||||||0.49||||||Relationship between CAC and PT failures. CAC risk category (low, low-mod, mod-high, high, very high risk) and PT failures (with, without PT failure)|Fisher Exact|Relationship between 2 variables (CAC - each risk category, PT failure - with/without PT failure) expressed as a p-value||CAC risk categories (low, low-moderate, mod -high, high, and very high)||||0.49
72569938|NCT02504671|144670131|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||Week 4. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
72569939|NCT02504671|144670131|OTHER||Difference|10.8|||||TWO_SIDED|95.0|0.8|20.8|||||Week 4. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||20.8|0.8|
72569940|NCT02504671|144670131|OTHER||Difference|-2.7|||||TWO_SIDED|95.0|-11.7|6.3|||||95% CI were constructed using asymptotic Wald confidence limits without correction.|||6.3|-11.7|
72569941|NCT02504671|144670131|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-8.7|14.1|||||Week 6. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||14.1|-8.7|
72569942|NCT02504671|144670131|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-6.3|11.7|||||Week 8. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||11.7|-6.3|
72405955|NCT03548584|144320326|SUPERIORITY||LS Mean Difference|-5.32||||0.0026|TWO_SIDED|95.0|-8.77|-1.87||MMRM method with model terms of treatment, trial site, visit, treatment-by-visit and baseline-by-visit interaction were used for analysis.|MMRM|||Change from Baseline at Week 12||-1.87|-8.77|0.0026
72521434|NCT02009930|144571673|OTHER|||||||0.11||||||Relationship between FRS and overall years of service. FRS risk category (low, mod, mod-high, high, very high risk) and overall years of service (15-19, 20-24, 25+)|Fisher Exact|Relationship between 2 variables (FRS - each risk category, overall years of service) expressed as a p-value||FRS risk categories (low, moderate, moderate -high, high, and very high)||||0.11
72521435|NCT02009930|144571673|OTHER|||||||0.003||||||Relationship between CAC and overall years of service. CAC risk category (low, low-mod, mod-high, high, very high risk) and overall years of service (15-19, 20-24, 25+)|Fisher Exact|Relationship between 2 variables (CAC - each risk category, overall years of service) expressed as a p-value||CAC risk category (low, low-mod, mod-high, high, very high risk)||||0.003
72521436|NCT02009930|144571675|OTHER|||||||0.21||||||Relationship between CAC and metabolic syndrome. CAC risk category (low, low-mod, mod-high, high, very high risk) and metabolic syndrome (presence/absence of metabolic syndrome)|Fisher Exact|Relationship between 2 variables (CAC - each risk category, metabolic syndrome - presence/absence) expressed as a p-value||CAC risk category (low, low-mod, mod-high, high, very high)||||0.21
72521437|NCT02009930|144571676|OTHER|||||||0.13||||||Relationship between CAC and living in the dorms. CAC risk category (low, low-mod, mod-high, high, very high risk) and living in the dorms (\< 5 years, \> 5 years)|Fisher Exact|Relationship between 2 variables (CAC - each risk category, living in the dorms - \<5 years/\> 5 years) expressed as a p-value||CAC risk category (low, low-mod, moderate - high, high, and very high)||||0.13
72569943|NCT02504671|144670131|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-4.8|15.6|||||Week 8. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||15.6|-4.8|
72569944|NCT02504671|144670131|OTHER||Difference|0.0|||||TWO_SIDED|95.0|-7.4|7.4|||||Week 12. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.4|-7.4|
72569945|NCT02504671|144670131|OTHER||Difference|13.5|||||TWO_SIDED|95.0|0.5|26.5|||||Week 12. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||26.5|0.5|
72569946|NCT02504671|144670131|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||Week 16. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
72569947|NCT02504671|144670131|OTHER||Difference|18.9|||||TWO_SIDED|95.0|6.3|31.5|||||Week 16. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||31.5|6.3|
72569948|NCT02504671|144670131|OTHER||Difference|10.8|||||TWO_SIDED|95.0|-1.4|23.0|||||Week 20. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||23.0|-1.4|
72569949|NCT02504671|144670131|OTHER||Difference|13.5|||||TWO_SIDED|95.0|0.5|26.5|||||Week 20. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||26.5|0.5|
72569950|NCT02504671|144670131|OTHER||Difference|10.8|||||TWO_SIDED|95.0|-1.4|23.0|||||Week 24. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||23.0|-1.4|
72569951|NCT02504671|144670131|OTHER||Difference|10.8|||||TWO_SIDED|95.0|-1.4|23.0|||||Week 24. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||23.0|-1.4|
72405956|NCT03548584|144320327|SUPERIORITY||LS Mean Difference|0.05||||0.3048|TWO_SIDED|95.0|-0.05|0.16||MMRM method with model terms of treatment, trial site, visit, treatment-by-visit and baseline-by-visit interaction were used for analysis.|MMRM|||Change from Baseline at Week 2||0.16|-0.05|0.3048
72405957|NCT03548584|144320327|SUPERIORITY||LS Mean Difference|-0.03||||0.7058|TWO_SIDED|95.0|-0.17|0.12||MMRM method with model terms of treatment, trial site, visit, treatment-by-visit and baseline-by-visit interaction were used for analysis.|MMRM|||Change from Baseline at Week 4||0.12|-0.17|0.7058
72521438|NCT02009930|144571677|OTHER|||||||0.49||||||Relationship between CAC and PT failures. CAC risk category (low, low-mod, mod-high, high, very high risk) and PT failures (with, without PT failure)|Fisher Exact|Relationship between 2 variables (CAC - each risk category, PT failure - with/without PT failure) expressed as a p-value||CAC risk categories (low, low-moderate, mod -high, high, and very high)||||0.49
72521439|NCT02009930|144571678|OTHER|||||||0.003||||||Relationship between CAC and overall years of service. CAC risk category (low, low-mod, mod-high, high, very high risk) and overall years of service (15-19, 20-24, 25+)|Fisher Exact|Relationship between 2 variables (CAC - each risk category, overall years of service) expressed as a p-value||CAC risk category (low, low-mod, mod-high, high, very high risk)||||0.003
72521440|NCT03300427|144571681|SUPERIORITY||difference in least square means|-900.0||||0.7594|TWO_SIDED|95.0|-6781.7|4981.8|||ANCOVA|||The study hypothesis is that short-term therapy with sacubitril/valsartan added on standard HF therapy improves cardiac efficiency in subjects with systolic HF.||4981.8|-6781.7|0.7594
72521441|NCT03300427|144571683|SUPERIORITY||difference in least square means|-575.5||||0.8422|TWO_SIDED|95.0|-6365.5|5214.5|||ANCOVA|||The study hypothesis is that short-term therapy with sacubitril/valsartan added on standard HF therapy improves cardiac efficiency in subjects with systolic HF.||5214.5|-6365.5|0.8422
72521442|NCT04839393|144571708|OTHER|The ratio and 90% confidence interval were expressed as percentages.|Adjusted Geometric Mean Ratio (%)|108.86|||||TWO_SIDED|90.0|87.24|135.84|||Mixed Models Analysis|||||135.84|87.24|
72569952|NCT02504671|144670131|OTHER||Difference|10.8|||||TWO_SIDED|95.0|-1.4|23.0|||||Week 28. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||23.0|-1.4|
72569953|NCT02504671|144670131|OTHER||Difference|18.9|||||TWO_SIDED|95.0|4.7|33.2|||||Week 28. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||33.2|4.7|
72625003|NCT03440385|144779531|SUPERIORITY||Odds Ratio (OR)|1.27||||0.4339|TWO_SIDED|95.0|0.7|2.31|||Cochran-Mantel-Haenszel|Odds ratio and p-value are obtained using the CMH test stratified by corticosteroid use at baseline (yes or no), and prior biologic use (yes or no).||||2.31|0.70|0.4339
72405958|NCT03548584|144320327|SUPERIORITY||LS Mean Difference|-0.06||||0.4516|TWO_SIDED|95.0|-0.23|0.1||MMRM method with model terms of treatment, trial site, visit, treatment-by-visit and baseline-by-visit interaction were used for analysis.|MMRM|||Change from Baseline at Week 6||0.10|-0.23|0.4516
72405959|NCT03548584|144320327|SUPERIORITY||LS Mean Difference|-0.27||||0.0052|TWO_SIDED|95.0|-0.46|-0.08||MMRM method with model terms of treatment, trial site, visit, treatment-by-visit and baseline-by-visit interaction were used for analysis.|MMRM|||Change from Baseline at Week 8||-0.08|-0.46|0.0052
72521443|NCT04839393|144571709|OTHER|The ratio and 90% confidence interval were expressed as percentages.|Adjusted Geometric Mean Ratio|113.14|||||TWO_SIDED|90.0|89.34|143.28|||Mixed Models Analysis|||||143.28|89.34|
72521444|NCT04839393|144571710|OTHER|The ratio and 90% confidence interval were expressed as percentages|Adjusted Geometric Mean Ratio|38.73|||||TWO_SIDED|90.0|32.8|45.74|||Mixed Models Analysis|||The test treatment was PF-06865571 300 mg + PF-06882961 200 mg BID (Period 3 - Day 47), which was reported separately in comparison to the reference treatment of PF-06865571 300 mg (Period 1 - Day 1).||45.74|32.80|
72521445|NCT04839393|144571711|OTHER|The ratio and 90% confidence interval were expressed as percentages|Adjusted Geometric Mean Ratio|73.91|||||TWO_SIDED|90.0|67.95|80.4|||Mixed Models Analysis|||||80.40|67.95|
72521446|NCT04839393|144571712|OTHER|The ratio and 90% confidence interval were expressed as percentages|Adjusted Geometric Mean Ratio|73.2|||||TWO_SIDED|90.0|66.82|80.18|||Mixed Models Analysis|||||80.18|66.82|
72521447|NCT04839393|144571713|OTHER|The ratio and 90% confidence interval were expressed as percentages|Adjusted Geometric Mean Ratio|115.3|||||TWO_SIDED|90.0|85.37|155.73|||Mixed Models Analysis|||||155.73|85.37|
72521448|NCT04839393|144571714|OTHER|The ratio and 90% confidence interval were expressed as percentages|Adjusted Geometric Mean Ratio|118.64|||||TWO_SIDED|90.0|94.05|149.66|||Mixed Models Analysis|||||149.66|94.05|
72521449|NCT00671970|144571736|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|||||||1.0
72521450|NCT00671970|144571737|SUPERIORITY_OR_OTHER|||||||0.613||95.0|||||Fisher Exact|||||||.613
72521451|NCT00671970|144571738|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|||||||1.0
72521452|NCT00671970|144571739|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|||||||1.0
72521453|NCT00671970|144571740|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|||||||1.0
72521454|NCT00671970|144571741|SUPERIORITY_OR_OTHER|||||||0.179||95.0|||||Wilcoxon (Mann-Whitney)|||||||.179
72521455|NCT00671970|144571742|SUPERIORITY_OR_OTHER|||||||0.008||95.0|||||Wilcoxon (Mann-Whitney)|||||||.008
72521456|NCT00633893|144571743|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.3283|||<|0.0001|TWO_SIDED|95.0|0.2225|0.4844||Hochberg adjusted p-value for superiority based on 2 hypotheses tests for apixaban 2.5mg group comparing with placebo group and for apixaban 5mg group comparing with placebo group.|Cochran-Mantel-Haenszel|||Null hypothesis is relative risk proportion of apixaban participants with VTE/all cause mortality to proportion of placebo participants with VTE/all cause mortality equal to 1.0. Participants with missing data were assumed to have experienced VTE/all cause mortality. Events occurring anytime during the intended treatment period (12 months) were included regardless of whether the participant was on treatment or not or whether the participant ever took drug, ie, Intent to treat (ITT) principle.||0.4844|0.2225|<0.0001
72569954|NCT02504671|144670131|OTHER||Difference|8.1|||||TWO_SIDED|95.0|-3.2|19.4|||||Week 32. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||19.4|-3.2|
72569955|NCT02504671|144670131|OTHER||Difference|16.2|||||TWO_SIDED|95.0|2.6|29.9|||||Week 32. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||29.9|2.6|
72569956|NCT02504671|144670131|OTHER||Difference|13.5|||||TWO_SIDED|95.0|0.5|26.5|||||Week 36. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||26.5|0.5|
72569957|NCT02504671|144670131|OTHER||Difference|16.2|||||TWO_SIDED|95.0|2.6|29.9|||||Week 36, 95% CI were constructed using asymptotic Wald confidence limits without correction.|||29.9|2.6|
72625004|NCT03440385|144779532|SUPERIORITY||Odds Ratio (OR)|1.3||||0.333|TWO_SIDED|95.0|0.77|2.2|||Cochran-Mantel-Haenszel|Odds ratio, and p-value are obtained using the CMH test stratified by corticosteroid use at baseline (yes or no), and prior biologic use (yes or no).||||2.20|0.77|0.3330
72625005|NCT03440385|144779533|SUPERIORITY||Odds Ratio (OR)|1.04||||0.82|TWO_SIDED|95.0|0.74|1.47|||Cochran-Mantel-Haenszel|Odds ratio and p-value are obtained using the CMH test stratified by corticosteroid use at baseline (yes or no), and prior biologic use (yes or no).||||1.47|0.74|0.8200
72625006|NCT03440385|144779534|SUPERIORITY||Odds Ratio (OR)|1.06||||0.7776|TWO_SIDED|95.0|0.71|1.59|||Cochran-Mantel-Haenszel|Odds ratio and p-value are obtained using the CMH test stratified by corticosteroid use at baseline (yes or no), and prior biologic use (yes or no).||||1.59|0.71|0.7776
72405960|NCT03548584|144320327|SUPERIORITY||LS Mean Difference|-0.27||||0.006|TWO_SIDED|95.0|-0.47|-0.08||MMRM method with model terms of treatment, trial site, visit, treatment-by-visit and baseline-by-visit interaction were used for analysis.|MMRM|||Change from Baseline at Week 10||-0.08|-0.47|0.0060
72405961|NCT03548584|144320327|SUPERIORITY||LS Mean Difference|-0.27||||0.0078|TWO_SIDED|95.0|-0.47|-0.07||MMRM method with model terms of treatment, trial site, visit, treatment-by-visit and baseline-by-visit interaction were used for analysis.|MMRM|||Change from Baseline at Week 12||-0.07|-0.47|0.0078
72405962|NCT03548584|144320328|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.1975|TWO_SIDED|95.0|-0.05|0.26|||Cochran-Mantel-Haenszel|||Week 2||0.26|-0.05|0.1975
72405963|NCT03548584|144320328|SUPERIORITY||Mean Difference (Final Values)|-0.25||||0.0084|TWO_SIDED|95.0|-0.44|-0.06|||Cochran-Mantel-Haenszel|||Week 4||-0.06|-0.44|0.0084
72405964|NCT03548584|144320328|SUPERIORITY||Mean Difference (Final Values)|-0.26||||0.0101|TWO_SIDED|95.0|-0.46|-0.06|||Cochran-Mantel-Haenszel|||Week 6||-0.06|-0.46|0.0101
72405965|NCT03548584|144320328|SUPERIORITY||Mean Difference (Final Values)|-0.37||||0.0008|TWO_SIDED|95.0|-0.59|-0.15|||Cochran-Mantel-Haenszel|||Week 8||-0.15|-0.59|0.0008
72405966|NCT03548584|144320328|SUPERIORITY||Mean Difference (Final Values)|-0.34||||0.0023|TWO_SIDED|95.0|-0.55|-0.12|||Cochran-Mantel-Haenszel|||Week 10||-0.12|-0.55|0.0023
72405967|NCT03548584|144320328|SUPERIORITY||Mean Difference (Final Values)|-0.33||||0.007|TWO_SIDED|95.0|-0.57|-0.09|||Cochran-Mantel-Haenszel|||Week 12||-0.09|-0.57|0.0070
72405968|NCT03548584|144320329|SUPERIORITY||Ratio of Response Rate|1.1||||0.729|TWO_SIDED|95.0|0.64|1.91|||Cochran-Mantel-Haenszel|||\>/= 20%: Week 2||1.91|0.64|0.7290
72405969|NCT03548584|144320329|SUPERIORITY||Ratio of Response Rate|1.09||||0.6196|TWO_SIDED|95.0|0.78|1.52|||Cochran-Mantel-Haenszel|||\>/=20%: Week 4||1.52|0.78|0.6196
72405970|NCT03548584|144320329|SUPERIORITY||Ratio of Response Rate|1.16||||0.2718|TWO_SIDED|95.0|0.88|1.53|||Cochran-Mantel-Haenszel|||\>/=20%: Week 6||1.53|0.88|0.2718
72405971|NCT03548584|144320329|SUPERIORITY||Ratio of Response Rate|1.52||||0.0004|TWO_SIDED|95.0|1.19|1.93|||Cochran-Mantel-Haenszel|||\>/=20%: Week 8||1.93|1.19|0.0004
72405972|NCT03548584|144320329|SUPERIORITY||Ratio of Response Rate|1.42||||0.0006|TWO_SIDED|95.0|1.15|1.76|||Cochran-Mantel-Haenszel|||\>/=20%: Week 10||1.76|1.15|0.0006
72405973|NCT03548584|144320329|SUPERIORITY||Ratio of Response Rate|1.41||||0.0004|TWO_SIDED|95.0|1.15|1.72|||Cochran-Mantel-Haenszel|||\>/=20%: Week 12||1.72|1.15|0.0004
72405974|NCT03548584|144320329|SUPERIORITY||Ratio of Response Rate|1.22||||0.7211|TWO_SIDED|95.0|0.39|3.85|||Cochran-Mantel-Haenszel|||\>/=30%: Week 2||3.85|0.39|0.7211
72405975|NCT03548584|144320329|SUPERIORITY||Ratio of Response Rate|1.11||||0.7606|TWO_SIDED|95.0|0.57|2.14|||Cochran-Mantel-Haenszel|||\>/=30%: Week 4||2.14|0.57|0.7606
72405976|NCT03548584|144320329|SUPERIORITY||Ratio of Response Rate|1.12||||0.5902|TWO_SIDED|95.0|0.74|1.68|||Cochran-Mantel-Haenszel|||\>/=30%: Week 6||1.68|0.74|0.5902
72405977|NCT03548584|144320329|SUPERIORITY||Ratio of Response Rate|1.7||||0.0054|TWO_SIDED|95.0|1.14|2.54|||Cochran-Mantel-Haenszel|||\>/=30%: Week 8||2.54|1.14|0.0054
72405978|NCT03548584|144320329|SUPERIORITY||Ratio of Response Rate|1.59||||0.0066|TWO_SIDED|95.0|1.11|2.26|||Cochran-Mantel-Haenszel|||\>/=30%: Week 10||2.26|1.11|0.0066
72405979|NCT03548584|144320329|SUPERIORITY||Ratio of Response Rate|1.62||||0.0017|TWO_SIDED|95.0|1.18|2.23|||Cochran-Mantel-Haenszel|||\>/=30%: Week 12||2.23|1.18|0.0017
72405980|NCT03548584|144320329|SUPERIORITY||Ratio of Response Rate|1.11||||0.9074|TWO_SIDED|95.0|0.2|5.97|||Cochran-Mantel-Haenszel|||\>/=40%: Week 2||5.97|0.20|0.9074
72405981|NCT03548584|144320329|SUPERIORITY||Ratio of Response Rate|0.98||||0.9625|TWO_SIDED|95.0|0.36|2.64|||Cochran-Mantel-Haenszel|||\>/=40%: Week 4||2.64|0.36|0.9625
72405982|NCT03548584|144320329|SUPERIORITY||Ratio of Response Rate|1.26||||0.512|TWO_SIDED|95.0|0.63|2.53|||Cochran-Mantel-Haenszel|||\>/=40%: Week 6||2.53|0.63|0.5120
72405983|NCT03548584|144320329|SUPERIORITY||Ratio of Response Rate|1.98||||0.0244|TWO_SIDED|95.0|1.03|3.79|||Cochran-Mantel-Haenszel|||\>/=40%: Week 8||3.79|1.03|0.0244
72405984|NCT03548584|144320329|SUPERIORITY||Ratio of Response Rate|1.86||||0.0161|TWO_SIDED|95.0|1.08|3.18|||Cochran-Mantel-Haenszel|||\>/=40%: Week 10||3.18|1.08|0.0161
72405985|NCT03548584|144320329|SUPERIORITY||Ratio of Response Rate|1.62||||0.0347|TWO_SIDED|95.0|1.0|2.61|||Cochran-Mantel-Haenszel|||\>/=40%: Week 12||2.61|1.00|0.0347
72405986|NCT03548584|144320330|SUPERIORITY||Ratio of Response Rate|0.64||||0.1503|TWO_SIDED|95.0|0.35|1.16|||Cochran-Mantel-Haenszel|||Week 2||1.16|0.35|0.1503
72405987|NCT03548584|144320330|SUPERIORITY||Ratio of Response Rate|1.07||||0.7559|TWO_SIDED|95.0|0.69|1.67|||Cochran-Mantel-Haenszel|||Week 4||1.67|0.69|0.7559
72405988|NCT03548584|144320330|SUPERIORITY||Ratio of Response Rate|1.23||||0.2246|TWO_SIDED|95.0|0.88|1.72|||Cochran-Mantel-Haenszel|||Week 6||1.72|0.88|0.2246
72405989|NCT03548584|144320330|SUPERIORITY||Ratio of Response Rate|1.38||||0.0276|TWO_SIDED|95.0|1.02|1.87|||Cochran-Mantel-Haenszel|||Week 8||1.87|1.02|0.0276
72405990|NCT03548584|144320330|SUPERIORITY||Ratio of Response Rate|1.46||||0.0031|TWO_SIDED|95.0|1.12|1.89|||Cochran-Mantel-Haenszel|||Week 10||1.89|1.12|0.0031
72405991|NCT03548584|144320330|SUPERIORITY||Ratio of Response Rate|1.47||||0.0017|TWO_SIDED|95.0|1.14|1.89|||Cochran-Mantel-Haenszel|||Week 12||1.89|1.14|0.0017
72405992|NCT03548584|144320331|SUPERIORITY||Ratio of Response Rate|1.1||||0.8549|TWO_SIDED|95.0|0.4|3.03|||Cochran-Mantel-Haenszel|||Week 2||3.03|0.40|0.8549
72405993|NCT03548584|144320331|SUPERIORITY||Ratio of Response Rate|1.95||||0.0093|TWO_SIDED|95.0|1.14|3.32|||Cochran-Mantel-Haenszel|||Week 4||3.32|1.14|0.0093
72569958|NCT02504671|144670131|OTHER||Difference|10.8|||||TWO_SIDED|95.0|0.8|20.8|||||Week 40. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||20.8|0.8|
72569959|NCT02504671|144670131|OTHER||Difference|24.3|||||TWO_SIDED|95.0|10.5|38.1|||||Week 40. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||38.1|10.5|
72569960|NCT02504671|144670131|OTHER||Difference|10.8|||||TWO_SIDED|95.0|-1.4|23.0|||||Week 44. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||23.0|-1.4|
72569961|NCT02504671|144670131|OTHER||Difference|13.5|||||TWO_SIDED|95.0|0.5|26.5|||||Week 44. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||26.5|0.5|
72569962|NCT02504671|144670131|OTHER||Difference|13.5|||||TWO_SIDED|95.0|2.5|24.5|||||Week 48. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||24.5|2.5|
72569963|NCT02504671|144670131|OTHER||Difference|18.9|||||TWO_SIDED|95.0|6.3|31.5|||||Week 48. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||31.5|6.3|
72569964|NCT02504671|144670131|OTHER||Difference|10.8|||||TWO_SIDED|95.0|-1.4|23.0|||||Week 52. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||23.0|-1.4|
72569965|NCT02504671|144670131|OTHER||Difference|10.8|||||TWO_SIDED|95.0|-1.4|23.0|||||Week 52. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||23.0|-1.4|
72569966|NCT02504671|144670131|OTHER||Difference|8.1|||||TWO_SIDED|95.0|-3.2|19.4|||||Week 62 (follow-up). 95% CI were constructed using asymptotic Wald confidence limits without correction.|||19.4|-3.2|
72405994|NCT03548584|144320331|SUPERIORITY||Ratio of Response Rate|1.56||||0.0083|TWO_SIDED|95.0|1.1|2.22|||Cochran-Mantel-Haenszel|||Week 6||2.22|1.10|0.0083
72569967|NCT02504671|144670131|OTHER||Difference|16.2|||||TWO_SIDED|95.0|2.6|29.9|||||Week 62 (follow-up). 95% CI were constructed using asymptotic Wald confidence limits without correction.|||29.9|2.6|
72569968|NCT02504671|144670132|OTHER||Mean Difference (Net)|-0.32||||0.046|TWO_SIDED|95.0|-0.64|-0.01||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 1|||-0.01|-0.64|0.046
72569969|NCT02504671|144670132|OTHER||Mean Difference (Net)|-0.3||||0.071|TWO_SIDED|95.0|-0.62|0.03||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 1|||0.03|-0.62|0.071
72569970|NCT02504671|144670132|OTHER||Mean Difference (Net)|-0.37||||0.022|TWO_SIDED|95.0|-0.69|-0.05||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 1|||-0.05|-0.69|0.022
72569971|NCT02504671|144670132|OTHER||Mean Difference (Net)|-0.28||||0.16|TWO_SIDED|95.0|-0.67|0.11||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 2|||0.11|-0.67|0.160
72569972|NCT02504671|144670132|OTHER||Mean Difference (Net)|-0.32||||0.103|TWO_SIDED|95.0|-0.71|0.07||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 2|||0.07|-0.71|0.103
72569973|NCT02504671|144670132|OTHER||Mean Difference (Net)|-0.42||||0.034|TWO_SIDED|95.0|-0.8|-0.03||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 2|||-0.03|-0.80|0.034
72569974|NCT02504671|144670132|OTHER||Mean Difference (Net)|-0.4||||0.096|TWO_SIDED|95.0|-0.87|0.07||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4|||0.07|-0.87|0.096
72569975|NCT02504671|144670132|OTHER||Mean Difference (Net)|-0.56||||0.02|TWO_SIDED|95.0|-1.02|-0.09||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4|||-0.09|-1.02|0.020
72569976|NCT02504671|144670132|OTHER||Mean Difference (Net)|-0.76||||0.001|TWO_SIDED|95.0|-1.22|-0.29||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4|||-0.29|-1.22|0.001
72569977|NCT02504671|144670132|OTHER||Mean Difference (Net)|-0.42||||0.11|TWO_SIDED|95.0|-0.93|0.1||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 6|||0.10|-0.93|0.110
72569978|NCT02504671|144670132|OTHER||Mean Difference (Net)|-0.47||||0.076|TWO_SIDED|95.0|-0.98|0.05||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 6|||0.05|-0.98|0.076
72405995|NCT03548584|144320331|SUPERIORITY||Ratio of Response Rate|1.85|||<|0.0001|TWO_SIDED|95.0|1.32|2.58|||Cochran-Mantel-Haenszel|||Week 8||2.58|1.32|<.0001
72569979|NCT02504671|144670132|OTHER||Mean Difference (Net)|-0.61||||0.02|TWO_SIDED|95.0|-1.11|-0.1||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 6|||-0.10|-1.11|0.020
72569980|NCT02504671|144670132|OTHER||Mean Difference (Net)|-0.42||||0.128|TWO_SIDED|95.0|-0.97|0.12||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 8|||0.12|-0.97|0.128
72569981|NCT02504671|144670132|OTHER||Mean Difference (Net)|-0.78||||0.005|TWO_SIDED|95.0|-1.33|-0.24||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 8|||-0.24|-1.33|0.005
72569982|NCT02504671|144670132|OTHER||Mean Difference (Net)|-0.82||||0.003|TWO_SIDED|95.0|-1.36|-0.29||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 8|||-0.29|-1.36|0.003
72569983|NCT02504671|144670132|OTHER||Mean Difference (Net)|-0.53||||0.11|TWO_SIDED|95.0|-1.17|0.12||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12|||0.12|-1.17|0.110
72569984|NCT02504671|144670132|OTHER||Mean Difference (Net)|-0.88||||0.008|TWO_SIDED|95.0|-1.53|-0.23||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12|||-0.23|-1.53|0.008
72569985|NCT02504671|144670132|OTHER||Mean Difference (Net)|-1.24|||<|0.001|TWO_SIDED|95.0|-1.88|-0.6||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12|||-0.60|-1.88|<0.001
72405996|NCT03548584|144320331|SUPERIORITY||Ratio of Response Rate|1.57||||0.0005|TWO_SIDED|95.0|1.18|2.09|||Cochran-Mantel-Haenszel|||Week 10||2.09|1.18|0.0005
72521457|NCT00633893|144571743|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.3615|||<|0.0001|TWO_SIDED|95.0|0.2475|0.5281||Hochberg adjusted p-value for superiority based on 2 hypotheses tests for apixaban 2.5mg group comparing with placebo group and for apixaban 5mg group comparing with placebo group.|Cochran-Mantel-Haenszel|||Null hypothesis is relative risk proportion of apixaban participants with VTE/all cause mortality to proportion of placebo participants with VTE/all cause mortality equal to 1.0. Participants with missing data were assumed to have experienced VTE/all cause mortality. Events occurring anytime during the intended treatment period (12 months) were included regardless of whether the participant was on treatment or not or whether the participant ever took drug, ie, Intent to treat principle.||0.5281|0.2475|<0.0001
72521458|NCT00633893|144571744|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.2891|||<|0.0001|TWO_SIDED|95.0|0.1902|0.4395||Hochberg adjusted p-value for superiority based on 2 hypotheses tests for apixaban 2.5mg group comparing with placebo group and for apixaban 5mg group comparing with placebo group.|Cochran-Mantel-Haenszel|||Null hypothesis is relative risk proportion of apixaban participants with VTE/VTE-related death to proportion of placebo participants with VTE/ VTE-related death equal to 1.0. Participants with missing data were assumed to have experienced VTE/ VTE-related death. Events occurring anytime during the intended treatment period (12 months) were included regardless of whether the participant was on treatment or not or whether the participant ever took drug, ie, ITT principle.||0.4395|0.1902|<0.0001
72521459|NCT00633893|144571744|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.3774|||<|0.0001|TWO_SIDED|95.0|0.2577|0.5525||Hochberg adjusted p-value for superiority based on 2 hypotheses tests for apixaban 2.5mg group comparing with placebo group and for apixaban 5mg group comparing with placebo group.|Cochran-Mantel-Haenszel|||Null hypothesis is relative risk proportion of apixaban participants with VTE/VTE-related death to proportion of placebo participants with VTE/ VTE-related death equal to 1.0. Participants with missing data were assumed to have experienced VTE/ VTE-related death. Events occurring anytime during the intended treatment period (12 months) were included regardless of whether the participant was on treatment or not or whether the participant ever took drug, ie, ITT principle.||0.5525|0.2577|<0.0001
72521460|NCT00633893|144571745|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.2422|||<|0.0001|TWO_SIDED|95.0|0.1476|0.3975||Hochberg adjusted p-value for superiority based on 2 hypotheses tests for apixaban 2.5mg group comparing with placebo group and for apixaban 5mg group comparing with placebo group.|Cochran-Mantel-Haenszel|||Null hypothesis is relative risk proportion of apixaban participants with VTE/all cause mortality to proportion of placebo participants with VTE/all cause mortality equal to 1.0. Events occurring anytime during the intended treatment period (12 months) were included regardless of whether the participant was on treatment or not or whether the participant ever took drug, ie, Intent to treat (ITT) principle.||0.3975|0.1476|<0.0001
72405997|NCT03548584|144320331|SUPERIORITY||Ratio of Response Rate|1.32||||0.016|TWO_SIDED|95.0|1.03|1.69|||Cochran-Mantel-Haenszel|||Week 12||1.69|1.03|0.0160
72405998|NCT02215070|144320335|OTHER|||||||0.12|||||||Chi-squared|||||||0.12
72405999|NCT02215070|144320337|OTHER|||||||0.006|||||||Log Rank|||||||0.006
72406000|NCT02215070|144320338|OTHER|||||||0.002|||||||Log Rank|||||||0.002
72406001|NCT00653224|144320347|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.89|||<|0.001||95.0|-1.33|-0.45||If the p-value of this estimated difference is lower than 5% the mean T5SS is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the mean of T5SS including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis for the primary endpoint is expressed as follows: 'The mean 24-hr reflective T5SS over the total treatment period is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.45|-1.33|<0.001
72521461|NCT00633893|144571745|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.1861|||<|0.0001|TWO_SIDED|95.0|0.1062|0.3261||Hochberg adjusted p-value for superiority based on 2 hypotheses tests for apixaban 2.5mg group comparing with placebo group and for apixaban 5mg group comparing with placebo group.|Cochran-Mantel-Haenszel|||Null hypothesis is relative risk proportion of apixaban participants with VTE/all cause mortality to proportion of placebo participants with VTE/all cause mortality equal to 1.0. Events occurring anytime during the intended treatment period (12 months) were included regardless of whether the participant was on treatment or not or whether the participant ever took drug, ie, Intent to treat (ITT) principle.||0.3261|0.1062|<0.0001
72521462|NCT00633893|144571746|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.2799|||<|0.0001|TWO_SIDED|95.0|0.1844|0.4247||Hochberg adjusted p-value for superiority based on 2 hypotheses tests for apixaban 2.5mg group comparing with placebo group and for apixaban 5mg group comparing with placebo group.|Cochran-Mantel-Haenszel|||Null hypothesis is relative risk proportion of apixaban participants with VTE/CV-related death to proportion of placebo participants with VTE/CV-related death equal to 1.0. Participants with missing data were assumed to have experienced VTE/CV-related death. Events occurring anytime during the intended treatment period (12 months) were included regardless of whether the participant was on treatment or not or whether the participant ever took drug, ie, ITT principle.||0.4247|0.1844|<0.0001
72521463|NCT00633893|144571746|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.3653|||<|0.0001|TWO_SIDED|95.0|0.25|0.5338||Hochberg adjusted p-value for superiority based on 2 hypotheses tests for apixaban 2.5mg group comparing with placebo group and for apixaban 5mg group comparing with placebo group.|Cochran-Mantel-Haenszel|||Null hypothesis is relative risk proportion of apixaban participants with VTE/CV-related death to proportion of placebo participants with VTE/CV-related death equal to 1.0. Participants with missing data were assumed to have experienced VTE/CV-related death. Events occurring anytime during the intended treatment period (12 months) were included regardless of whether the participant was on treatment or not or whether the participant ever took drug, ie, ITT principle.||0.5338|0.2500|<0.0001
72521464|NCT00633893|144571747|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.2615|||<|0.0001|TWO_SIDED|95.0|0.1593|0.4292||Hochberg adjusted p-value for superiority based on 2 hypotheses tests for apixaban 2.5mg group comparing with placebo group and for apixaban 5mg group comparing with placebo group.|Cochran-Mantel-Haenszel|||Null hypothesis is relative risk proportion of apixaban participants with nonfatal DVT to proportion of placebo participants with nonfatal DVT equal to 1.0. Participants with missing data were assumed to have experienced nonfatal DVT. Events occurring anytime during the intended treatment period (12 months) were included regardless of whether the participant was on treatment or not or whether the participant ever took drug, ie, Intent to treat (ITT) principle.||0.4292|0.1593|<0.0001
72521465|NCT00633893|144571747|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.3972|||<|0.0001|TWO_SIDED|95.0|0.2595|0.6079||Hochberg adjusted p-value for superiority based on 2 hypotheses tests for apixaban 2.5mg group comparing with placebo group and for apixaban 5mg group comparing with placebo group.|Cochran-Mantel-Haenszel|||Null hypothesis is relative risk proportion of apixaban participants with nonfatal DVT to proportion of placebo participants with nonfatal DVT equal to 1.0. Participants with missing data were assumed to have experienced nonfatal DVT. Events occurring anytime during the intended treatment period (12 months) were included regardless of whether the participant was on treatment or not or whether the participant ever took drug, ie, ITT principle.||0.6079|0.2595|<0.0001
72521466|NCT00633893|144571748|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.6087||||0.1084|TWO_SIDED|95.0|0.3653|1.0145||Hochberg adjusted p-value for superiority based on 2 hypotheses tests for apixaban 2.5mg group comparing with placebo group and for apixaban 5mg group comparing with placebo group.|Cochran-Mantel-Haenszel|||Null hypothesis is relative risk proportion of apixaban participants with nonfatal PE to proportion of placebo participants with nonfatal PE equal to 1.0. Participants with missing data were assumed to have experienced nonfatal PE. Events occurring anytime during the intended treatment period (12 months) were included regardless of whether the participant was on treatment or not or whether the participant ever took drug, ie, ITT principle.||1.0145|0.3653|0.1084
72521467|NCT00633893|144571748|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.6846||||0.1329|TWO_SIDED|95.0|0.4164|1.1257||Hochberg adjusted p-value for superiority based on 2 hypotheses tests for apixaban 2.5mg group comparing with placebo group and for apixaban 5mg group comparing with placebo group.|Cochran-Mantel-Haenszel|||Null hypothesis is relative risk proportion of apixaban participants with nonfatal PE to proportion of placebo participants with nonfatal PE equal to 1.0. Participants with missing data were assumed to have experienced nonfatal PE. Events occurring anytime during the intended treatment period (12 months) were included regardless of whether the participant was on treatment or not or whether the participant ever took drug, ie, ITT principle.||1.1257|0.4164|0.1329
72521468|NCT00633893|144571749|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.647||||0.3059|TWO_SIDED|95.0|0.3543|1.1813||Hochberg adjusted p-value for superiority based on 2 hypotheses tests for apixaban 2.5mg group comparing with placebo group and for apixaban 5mg group comparing with placebo group.|Cochran-Mantel-Haenszel|||Null hypothesis is relative risk proportion of apixaban participants with VTE-related death to proportion of placebo participants with VTE-related death equal to 1.0. Participants with missing data were assumed to have experienced VTE-related death. Events occurring anytime during the intended treatment period (12 months) were included regardless of whether the participant was on treatment or not or whether the participant ever took drug, ie, ITT principle.||1.1813|0.3543|0.3059
72521469|NCT00633893|144571749|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.9416||||0.8288|TWO_SIDED|95.0|0.5458|1.6245||Hochberg adjusted p-value for superiority based on 2 hypotheses tests for apixaban 2.5mg group comparing with placebo group and for apixaban 5mg group comparing with placebo group.|Cochran-Mantel-Haenszel|||Null hypothesis is relative risk proportion of apixaban participants with VTE-related death to proportion of placebo participants with VTE-related death equal to 1.0. Participants with missing data were assumed to have experienced VTE-related death. Events occurring anytime during the intended treatment period (12 months) were included regardless of whether the participant was on treatment or not or whether the participant ever took drug, ie, ITT principle.||1.6245|0.5458|0.8288
72521470|NCT00633893|144571750|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.5794||||0.1316|TWO_SIDED|95.0|0.3215|1.0443||Hochberg adjusted p-value for superiority based on 2 hypotheses tests for apixaban 2.5mg group comparing with placebo group and for apixaban 5mg group comparing with placebo group.|Cochran-Mantel-Haenszel|||Null hypothesis is relative risk proportion of apixaban participants with CV-related death to proportion of placebo participants with CV-related death equal to 1.0. Participants with missing data were assumed to have experienced CV-related death. Events occurring anytime during the intended treatment period (12 months) were included regardless of whether the participant was on treatment or not or whether the participant ever took drug, ie, ITT principle.||1.0443|0.3215|0.1316
72521471|NCT00633893|144571750|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.8433||||0.5288|TWO_SIDED|95.0|0.4959|1.4341||Hochberg adjusted p-value for superiority based on 2 hypotheses tests for apixaban 2.5mg group comparing with placebo group and for apixaban 5mg group comparing with placebo group.|Cochran-Mantel-Haenszel|||Null hypothesis is relative risk proportion of apixaban participants with CV-related death to proportion of placebo participants with CV-related death equal to 1.0. Participants with missing data were assumed to have experienced CV-related death. Events occurring anytime during the intended treatment period (12 months) were included regardless of whether the participant was on treatment or not or whether the participant ever took drug, ie, ITT principle.||1.4341|0.4959|0.5288
72521472|NCT00633893|144571751|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.6577||||0.2361|TWO_SIDED|95.0|0.3874|1.1169||Hochberg adjusted p-value for superiority based on 2 hypotheses tests for apixaban 2.5mg group comparing with placebo group and for apixaban 5mg group comparing with placebo group.|Cochran-Mantel-Haenszel|||Null hypothesis is relative risk proportion of apixaban participants with all cause mortality to proportion of placebo participants with all cause mortality equal to 1.0. Participants with missing data were assumed to have experienced all cause mortality. Events occurring anytime during the intended treatment period (12 months) were included regardless of whether the participant was on treatment or not or whether the participant ever took drug, ie, ITT principle.||1.1169|0.3874|0.2361
72569986|NCT02504671|144670132|OTHER||Mean Difference (Net)|-0.29||||0.5|TWO_SIDED|95.0|-1.15|0.56||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 16|||0.56|-1.15|0.500
72569987|NCT02504671|144670132|OTHER||Mean Difference (Net)|-0.99||||0.021|TWO_SIDED|95.0|-1.83|-0.15||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 16|||-0.15|-1.83|0.021
72521473|NCT00633893|144571751|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.7708||||0.3155|TWO_SIDED|95.0|0.4631|1.2832||Hochberg adjusted p-value for superiority based on 2 hypotheses tests for apixaban 2.5mg group comparing with placebo group and for apixaban 5mg group comparing with placebo group.|Cochran-Mantel-Haenszel|||Null hypothesis is relative risk proportion of apixaban participants with all cause mortality to proportion of placebo participants with all cause mortality equal to 1.0. Participants with missing data were assumed to have experienced all cause mortality. Events occurring anytime during the intended treatment period (12 months) were included regardless of whether the participant was on treatment or not or whether the participant ever took drug, ie, ITT principle.||1.2832|0.4631|0.3155
72406002|NCT00653224|144320348|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.34|||<|0.001||95.0|-0.52|-0.17||If the p-value of this estimated difference is lower than 5% the mean change from baseline in overall RQLQ score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the change from baseline in overall RQLQ score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean change from baseline in overall RQLQ score at endpoint visit is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.17|-0.52|<0.001
72406003|NCT00653224|144320349|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.31|||<|0.001||95.0|-0.47|-0.15||If the p-value of this estimated difference is lower than 5% the mean change from baseline in overall RQLQ score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the change from baseline in overall RQLQ score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean change from baseline in overall RQLQ score at visit 3 (week 1) is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.15|-0.47|<0.001
72521474|NCT00633893|144571753|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.485||||0.3925|TWO_SIDED|95.0|0.0891|2.6391||Hochberg adjusted p-value for superiority based on 2 hypotheses tests for apixaban 2.5mg group comparing with placebo group and for apixaban 5mg group comparing with placebo group.|Cochran-Mantel-Haenszel|||Null hypothesis is relative risk proportion of apixaban participants with major bleeding to proportion of placebo participants with major bleeding equal to 1.0. Treated participants with at least one dose of study drug were included.||2.6391|0.0891|0.3925
72521475|NCT00633893|144571753|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.2457||||0.3551|TWO_SIDED|95.0|0.0269|2.2437||Hochberg adjusted p-value for superiority based on 2 hypotheses tests for apixaban 2.5mg group comparing with placebo group and for apixaban 5mg group comparing with placebo group.|Cochran-Mantel-Haenszel|||Null hypothesis is relative risk proportion of apixaban participants with major bleeding to proportion of placebo participants with major bleeding equal to 1.0. Participants treated with at least one dose of study drug were included.||2.2437|0.0269|0.3551
72521476|NCT00633893|144571754|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.2027||||0.5148|TWO_SIDED|95.0|0.6897|2.0975||Hochberg adjusted p-value for superiority based on 2 hypotheses tests for apixaban 2.5mg group comparing with placebo group and for apixaban 5mg group comparing with placebo group.|Cochran-Mantel-Haenszel|||Null hypothesis is relative risk proportion of apixaban participants with major/clinically relevant non-major bleeding to proportion of placebo participants with major/clinically relevant non-major bleeding equal to 1.0.||2.0975|0.6897|0.5148
72521477|NCT00633893|144571754|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.616||||0.1412|TWO_SIDED|95.0|0.9554|2.7336||Hochberg adjusted p-value for superiority based on 2 hypotheses tests for apixaban 2.5mg group comparing with placebo group and for apixaban 5mg group comparing with placebo group.|Cochran-Mantel-Haenszel|||Null hypothesis is relative risk proportion of apixaban participants with major/clinically relevant non-major bleeding to proportion of placebo participants with major/clinically relevant non-major bleeding equal to 1.0.||2.7336|0.9554|0.1412
72569988|NCT02504671|144670132|OTHER||Mean Difference (Net)|-1.0||||0.017|TWO_SIDED|95.0|-1.83|-0.18||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 16|||-0.18|-1.83|0.017
72569989|NCT02504671|144670132|OTHER||Mean Difference (Net)|-0.07||||0.871|TWO_SIDED|95.0|-0.98|0.83||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 20|||0.83|-0.98|0.871
72569990|NCT02504671|144670132|OTHER||Mean Difference (Net)|-0.58||||0.19|TWO_SIDED|95.0|-1.46|0.29||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 20|||0.29|-1.46|0.190
72569991|NCT02504671|144670132|OTHER||Mean Difference (Net)|-0.66||||0.13|TWO_SIDED|95.0|-1.51|0.2||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 20|||0.20|-1.51|0.130
72569992|NCT02504671|144670132|OTHER||Mean Difference (Net)|-1.22||||0.019|TWO_SIDED|95.0|-2.24|-0.2||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24|||-0.20|-2.24|0.019
72569993|NCT02504671|144670132|OTHER||Mean Difference (Net)|-1.53||||0.002|TWO_SIDED|95.0|-2.51|-0.55||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24|||-0.55|-2.51|0.002
72569994|NCT02504671|144670132|OTHER||Mean Difference (Net)|-1.39||||0.005|TWO_SIDED|95.0|-2.34|-0.43||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24|||-0.43|-2.34|0.005
72569995|NCT02504671|144670132|OTHER||Mean Difference (Net)|-0.41||||0.013|TWO_SIDED|95.0|-0.73|-0.09||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 1|||-0.09|-0.73|0.013
72569996|NCT02504671|144670132|OTHER||Mean Difference (Net)|-0.49||||0.003|TWO_SIDED|95.0|-0.8|-0.17||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 1|||-0.17|-0.80|0.003
72569997|NCT02504671|144670132|OTHER||Mean Difference (Net)|-0.47||||0.017|TWO_SIDED|95.0|-0.86|-0.09||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 2|||-0.09|-0.86|0.017
72569998|NCT02504671|144670132|OTHER||Mean Difference (Net)|-0.52||||0.009|TWO_SIDED|95.0|-0.9|-0.13||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 2|||-0.13|-0.90|0.009
72569999|NCT02504671|144670132|OTHER||Mean Difference (Net)|-0.67||||0.005|TWO_SIDED|95.0|-1.13|-0.2||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4|||-0.20|-1.13|0.005
72570000|NCT02504671|144670132|OTHER||Mean Difference (Net)|-1.01|||<|0.001|TWO_SIDED|95.0|-1.48|-0.55||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4|||-0.55|-1.48|<0.001
72521478|NCT00633893|144571755|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.2928||||0.3932|TWO_SIDED|95.0|0.7158|2.3348||Hochberg adjusted p-value for superiority based on 2 hypotheses tests for apixaban 2.5mg group comparing with placebo group and for apixaban 5mg group comparing with placebo group.|Cochran-Mantel-Haenszel|||Null hypothesis is relative risk proportion of apixaban participants with clinically relevant non-major bleeding to proportion of placebo participants with clinically relevant non-major bleeding equal to 1.0.||2.3348|0.7158|0.3932
72521479|NCT00633893|144571755|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.8235||||0.0621||95.0|1.047|3.176||Hochberg adjusted p-value for superiority based on 2 hypotheses tests for apixaban 2.5mg group comparing with placebo group and for apixaban 5mg group comparing with placebo group.|Cochran-Mantel-Haenszel|||Null hypothesis is relative risk proportion of apixaban participants with clinically relevant non-major bleeding to proportion of placebo participants with clinically relevant non-major bleeding equal to 1.0.||3.1760|1.0470|0.0621
72521480|NCT00633893|144571756|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.2579||||0.1691|TWO_SIDED|95.0|0.9064|1.7457||Hochberg adjusted p-value for superiority based on 2 hypotheses tests for apixaban 2.5mg group comparing with placebo group and for apixaban 5mg group comparing with placebo group.|Cochran-Mantel-Haenszel|||Null hypothesis is relative risk proportion of apixaban participants with minor bleeding to proportion of placebo participants with minor bleeding equal to 1.0.||1.7457|0.9064|0.1691
72570001|NCT02504671|144670132|OTHER||Mean Difference (Net)|-0.47||||0.073|TWO_SIDED|95.0|-0.99|0.04||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 6|||0.04|-0.99|0.073
72570002|NCT02504671|144670132|OTHER||Mean Difference (Net)|-0.85||||0.001|TWO_SIDED|95.0|-1.36|-0.34||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 6|||-0.34|-1.36|0.001
72570003|NCT02504671|144670132|OTHER||Mean Difference (Net)|-0.89||||0.001|TWO_SIDED|95.0|-1.43|-0.35||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 8|||-0.35|-1.43|0.001
72570004|NCT02504671|144670132|OTHER||Mean Difference (Net)|-1.1|||<|0.001|TWO_SIDED|95.0|-1.65|-0.56||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 8|||-0.56|-1.65|<0.001
72570005|NCT02504671|144670132|OTHER||Mean Difference (Net)|-0.68||||0.039|TWO_SIDED|95.0|-1.32|-0.03||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12|||-0.03|-1.32|0.039
72570006|NCT02504671|144670132|OTHER||Mean Difference (Net)|-1.27|||<|0.001|TWO_SIDED|95.0|-1.91|-0.63||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12|||-0.63|-1.91|<0.001
72570007|NCT02504671|144670132|OTHER||Mean Difference (Net)|-0.77||||0.073|TWO_SIDED|95.0|-1.61|0.07||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 16|||0.07|-1.61|0.073
72570008|NCT02504671|144670132|OTHER||Mean Difference (Net)|-1.11||||0.007|TWO_SIDED|95.0|-1.91|-0.3||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 16|||-0.30|-1.91|0.007
72570009|NCT02504671|144670132|OTHER||Mean Difference (Net)|-0.77||||0.083|TWO_SIDED|95.0|-1.65|0.1||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 20|||0.10|-1.65|0.083
72570010|NCT02504671|144670132|OTHER||Mean Difference (Net)|-0.8||||0.059|TWO_SIDED|95.0|-1.63|0.03||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 20|||0.03|-1.63|0.059
72625007|NCT03440385|144779535|SUPERIORITY||Odds Ratio (OR)|1.39||||0.1187|TWO_SIDED|95.0|0.92|2.11|||Cochran-Mantel-Haenszel|Odds ratio and p-value are obtained using the CMH test stratified by corticosteroid use at baseline (yes or no), and prior biologic use (yes or no)||||2.11|0.92|0.1187
72521481|NCT00633893|144571756|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.6971||||0.0013|TWO_SIDED|95.0|1.2468|2.3102||Hochberg adjusted p-value for superiority based on 2 hypotheses tests for apixaban 2.5mg group comparing with placebo group and for apixaban 5mg group comparing with placebo group.|Cochran-Mantel-Haenszel|||Null hypothesis is relative risk proportion of apixaban participants with minor bleeding to proportion of placebo participants with minor bleeding equal to 1.0.||2.3102|1.2468|0.0013
72521482|NCT00633893|144571757|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.2374||||0.1466|TWO_SIDED|95.0|0.9276|1.6507||Hochberg adjusted p-value for superiority based on 2 hypotheses tests for apixaban 2.5mg group comparing with placebo group and for apixaban 5mg group comparing with placebo group.|Cochran-Mantel-Haenszel|||Null hypothesis is relative risk proportion of apixaban participants with total bleeding to proportion of placebo participants with total bleeding equal to 1.0. Total bleeding was defined as any major, clinically relevant non-major, or minor bleeding.||1.6507|0.9276|0.1466
72521483|NCT00633893|144571757|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.6468||||0.0005|TWO_SIDED|95.0|1.2552|2.1606||Hochberg adjusted p-value for superiority based on 2 hypotheses tests for apixaban 2.5mg group comparing with placebo group and for apixaban 5mg group comparing with placebo group.|Cochran-Mantel-Haenszel|||Null hypothesis is relative risk proportion of apixaban participants with total bleeding to proportion of placebo participants with total bleeding equal to 1.0. Total bleeding is any major, clinically relevant non-major, or minor bleeding.||2.1606|1.2552|0.0005
72570011|NCT02504671|144670132|OTHER||Mean Difference (Net)|-1.48||||0.003|TWO_SIDED|95.0|-2.46|-0.5||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24|||-0.50|-2.46|0.003
72570012|NCT02504671|144670132|OTHER||Mean Difference (Net)|-1.82|||<|0.001|TWO_SIDED|95.0|-2.75|-0.89||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24|||-0.89|-2.75|<0.001
72570013|NCT02504671|144670134|OTHER||Difference|16.2||||0.037|TWO_SIDED|95.0|1.1|31.4|||Regression, Logistic||Difference to placebo for Week 1 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||31.4|1.1|0.037
72570014|NCT02504671|144670134|OTHER||Difference|10.8||||0.144|TWO_SIDED|95.0|-3.1|24.7|||Regression, Logistic||Difference to placebo for Week 1 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||24.7|-3.1|0.144
72521484|NCT02741310|144571765|OTHER|The clinical hypothesis was that there would be no clinically meaningful difference between the blood pressure effects of sumatriptan alone and the effects of a single dose of erenumab IV and sumatriptan concomitant therapy. A clinically meaningful difference was defined as the upper bound of the 90% confidence interval (CI) of treatment difference between erenumab IV and sumatriptan compared to sumatriptan alone being ≥ 5 mmHg on the time-weighted scale resting MAP.|LS Mean Difference|-0.04|||||TWO_SIDED|90.0|-2.16|2.08||||||A linear mixed effects regression analysis was performed to assess if the time-weighted average in MAP for erenumab with sumatriptan is similar to sumatriptan alone. A two-sided 90% confidence interval (equivalent to a one-sided upper 95% CI) for the mean treatment difference was calculated using a linear mixed-effects model with fixed effects for treatment and period and a random effect for subject.||2.08|-2.16|
72521485|NCT02741310|144571767|OTHER||Geometric Least Squares Mean Ratio|0.98|||||TWO_SIDED|90.0|0.93|1.03||||||The mean for each treatment was compared using a linear mixed effects model with group A (sumatriptan alone) as the reference treatment group. The linear mixed effects model included treatment (erenumab with sumatriptan vs sumatriptan alone) and period as a fixed effect and subject as a random effect.||1.03|0.93|
72521486|NCT02741310|144571768|OTHER||Geometric Least Squares Mean Ratio|1.0|||||TWO_SIDED|90.0|0.96|1.05||||||The mean for each treatment was compared using a linear mixed effects model with group A (sumatriptan alone) as the reference treatment group. The linear mixed effects model included treatment (erenumab with sumatriptan vs sumatriptan alone) and period as a fixed effect and subject as a random effect.||1.05|0.96|
72521487|NCT02741310|144571769|OTHER||Geometric Least Squares Mean Ratio|0.95|||||TWO_SIDED|90.0|0.82|1.09||||||The mean for each treatment was compared using a linear mixed effects model with group A (sumatriptan alone) as the reference treatment group. The linear mixed effects model included treatment (erenumab with sumatriptan vs sumatriptan alone) and period as a fixed effect and subject as a random effect.||1.09|0.82|
72521488|NCT03417505|144571805|SUPERIORITY||||||<|0.01|||||||t-test, 1 sided|Paired t-test comparison||||||<0.01
72521489|NCT03417505|144571806|SUPERIORITY||||||<|0.05||||||Calculated p value was \<0.05.|Wilcoxon (Mann-Whitney)|Wilcoxon signed rank comparisons, one-sided||||||<0.05
72521490|NCT03417505|144571807|SUPERIORITY||||||<|0.01|||||||t-test, 1 sided|paired 1-sided t-test||||||<0.01
72521491|NCT03417505|144571808|SUPERIORITY||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|Wilcoxon signed rank comparison, one sided p value||||||<0.01
72521492|NCT03417505|144571809|SUPERIORITY||||||>|0.05||||||Calculated p value was \>0.05.|t-test, 1 sided|paired||||||>0.05
72521493|NCT03417505|144571810|SUPERIORITY||||||<|0.05||||||Calculated p value was \<0.05.|Wilcoxon (Mann-Whitney)|paired, 1-sided||||||<0.05
72570015|NCT02504671|144670134|OTHER||Difference|18.9||||0.033|TWO_SIDED|95.0|3.3|34.5|||Regression, Logistic||Difference to placebo for Week 1 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||34.5|3.3|0.033
72570016|NCT02504671|144670134|OTHER||Difference|5.4||||0.437|TWO_SIDED|95.0|-11.3|22.2|||Regression, Logistic||Difference to placebo for Week 2 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||22.2|-11.3|0.437
72570017|NCT02504671|144670134|OTHER||Difference|2.7||||0.755|TWO_SIDED|95.0|-13.5|18.9|||Regression, Logistic||Difference to placebo for Week 2 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||18.9|-13.5|0.755
72570018|NCT02504671|144670134|OTHER||Difference|24.3||||0.023|TWO_SIDED|95.0|5.2|43.4|||Regression, Logistic||Difference to placebo for Week 2 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||43.4|5.2|0.023
72570019|NCT02504671|144670134|OTHER||Difference|29.7||||0.006|TWO_SIDED|95.0|9.8|49.7|||Regression, Logistic||Difference to placebo for Week 4 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||49.7|9.8|0.006
72570020|NCT02504671|144670134|OTHER||Difference|21.6||||0.039|TWO_SIDED|95.0|2.0|41.2|||Regression, Logistic||Difference to placebo for Week 4 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||41.2|2.0|0.039
72521494|NCT03417505|144571811|SUPERIORITY||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|paired, 1-sided||||||<0.01
72521495|NCT03417505|144571812|SUPERIORITY||||||<|0.05||||||Calculated p value was \<0.05.|Wilcoxon (Mann-Whitney)|paired, 1-sided||||||<0.05
72521496|NCT03417505|144571813|SUPERIORITY||||||>|0.05||||||Calculated p value was \>0.05.|Wilcoxon (Mann-Whitney)|paired, 1-sided||||||>0.05
72521497|NCT00407550|144571828|SUPERIORITY|||||||0.015|||||||Log Rank|||||||0.015
72521498|NCT00407550|144571829|SUPERIORITY|||||||0.56|||||||Log Rank|||||||0.56
72521499|NCT00443846|144571831|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was concluded if the lower bound of the 95% confidence interval of the difference (Group 1 - Group 2) in seroprotection rate was greater than -10%.|Difference (Group 1 - Group 2)|0.0|||||TWO_SIDED|95.0|-3.7|3.7||||||Analysis of non-inferiority was based on the Miettinen and Nurminen method||3.7|-3.7|
72521500|NCT03689972|144571873|SUPERIORITY||Ratio of Mean|4.24|||=|0.0755|TWO_SIDED|95.0|0.86|20.85|||Negative Binomial Regression|The model included treatment as classification variable \& baseline body weight, duration of natalizumab exposure at baseline, \& region as covariates.||||20.85|0.86|=0.0755
72521501|NCT03689972|144571874|SUPERIORITY||Percentage|87.8|||||TWO_SIDED|95.0|80.68|93.01|||Exact Binomial method|Percentage of participants preferring natalizumab SC at end of crossover period of Part 2, and 95% CI was calculated using the exact binomial method.||||93.01|80.68|
72521502|NCT03689972|144571876|SUPERIORITY||Ratio of annualized relapse rate|1.32481|||=|0.6312|TWO_SIDED|95.0|0.42016|4.17725|||Poisson Regression|Poisson regression model was adjusted for baseline body weight, duration of natalizumab exposure at baseline, and region.||||4.17725|0.42016|=0.6312
72521503|NCT03689972|144571882|SUPERIORITY||Difference|0.47|||=|0.764|TWO_SIDED|95.0|-2.61|3.54||Performed with factors:route of administration,period,sequence,body weight,duration of natalizumab exposure,stratification factor,baseline TSQM score.|Linear Mixed Effects Model|||||3.54|-2.61|=0.764
72521504|NCT03689972|144571889|SUPERIORITY||Difference|0.08|||=|0.357|TWO_SIDED|95.0|-0.09|0.25||Performed with factors:route of administration,period,sequence,body weight,duration of natalizumab exposure,stratification factor,baseline TSQM score.|Linear Mixed Effects Model|||||0.25|-0.09|=0.357
72521505|NCT00324272|144571899|SUPERIORITY_OR_OTHER|||||||0.704||95.0|||||t-test, 2 sided|||||||0.704
72521506|NCT00324272|144571899|SUPERIORITY_OR_OTHER|||||||0.217||95.0|||||t-test, 2 sided|||||||0.217
72570021|NCT02504671|144670134|OTHER||Difference|29.7||||0.008|TWO_SIDED|95.0|9.8|49.7|||Regression, Logistic||Difference to placebo for Week 4 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||49.7|9.8|0.008
72570022|NCT02504671|144670134|OTHER||Difference|21.6||||0.044|TWO_SIDED|95.0|0.4|42.8|||Regression, Logistic||Difference to placebo for Week 4 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||42.8|0.4|0.044
72570023|NCT02504671|144670134|OTHER||Difference|18.9||||0.083|TWO_SIDED|95.0|-2.2|40.0|||Regression, Logistic||Difference to placebo for Week 6 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||40.0|-2.2|0.083
72570024|NCT02504671|144670134|OTHER||Difference|27.0|||||TWO_SIDED|95.0|5.8|48.3|||||Difference to placebo for Week 6 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||48.3|5.8|
72570025|NCT02504671|144670134|OTHER||Difference|10.8|||||TWO_SIDED|95.0|-11.2|32.8|||||Difference to placebo for Week 8 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.Wald confidence limits without correction.|||32.8|-11.2|
72570026|NCT02504671|144670134|OTHER||Difference|27.0|||||TWO_SIDED|95.0|5.2|48.9|||||Difference to placebo for Week 8 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||48.9|5.2|
72570027|NCT02504671|144670134|OTHER||Difference|32.4|||||TWO_SIDED|95.0|10.9|54.0|||||Difference to placebo for Week 8 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||54.0|10.9|
72570028|NCT02504671|144670134|OTHER||Difference|21.6|||||TWO_SIDED|95.0|0.9|42.4|||||Difference to placebo for Week 12 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||42.4|0.9|
72570029|NCT02504671|144670134|OTHER||Difference|29.7|||||TWO_SIDED|95.0|8.9|50.6|||||Difference to placebo for Week 12 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||50.6|8.9|
72570030|NCT02504671|144670134|OTHER||Difference|45.9|||||TWO_SIDED|95.0|25.9|66.0|||||Difference to placebo for Week 12 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||66.0|25.9|
72570031|NCT02504671|144670134|OTHER||Difference|13.5|||||TWO_SIDED|95.0|-6.8|33.8|||||Difference to placebo for Week 16 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||33.8|-6.8|
72570032|NCT02504671|144670134|OTHER||Difference|32.4|||||TWO_SIDED|95.0|11.6|53.3|||||Difference to placebo for Week 16 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||53.3|11.6|
72570033|NCT02504671|144670134|OTHER||Difference|37.8|||||TWO_SIDED|95.0|17.2|58.5|||||Difference to placebo for Week 16 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||58.5|17.2|
72570034|NCT02504671|144670134|OTHER||Difference|18.9|||||TWO_SIDED|95.0|-0.5|38.4|||||Difference to placebo for Week 20 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||38.4|-0.5|
72570035|NCT02504671|144670134|OTHER||Difference|35.1|||||TWO_SIDED|95.0|15.1|55.1|||||Difference to placebo for Week 20 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||55.1|15.1|
72570036|NCT02504671|144670134|OTHER||Difference|48.6|||||TWO_SIDED|95.0|29.2|68.1|||||Difference to placebo for Week 20 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||68.1|29.2|
72570037|NCT02504671|144670134|OTHER||Difference|16.2|||||TWO_SIDED|95.0|-3.0|35.4|||||Difference to placebo for Week 24 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||35.4|-3.0|
72570038|NCT02504671|144670134|OTHER||Difference|29.7|||||TWO_SIDED|95.0|9.8|49.7|||||Difference to placebo for Week 24 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||49.7|9.8|
72570039|NCT02504671|144670134|OTHER||Difference|37.8|||||TWO_SIDED|95.0|17.9|57.8|||||Difference to placebo for Week 24 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||57.8|17.9|
72570040|NCT02504671|144670134|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-4.8|15.6|||||Difference to placebo for Week 28 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||15.6|-4.8|
72570041|NCT02504671|144670134|OTHER||Difference|16.2|||||TWO_SIDED|95.0|2.6|29.9|||||Difference to placebo for Week 28 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||29.9|2.6|
72570042|NCT02504671|144670134|OTHER||Difference|16.2|||||TWO_SIDED|95.0|2.6|29.9|||||Difference to placebo for Week 28 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||29.9|2.6|
72570043|NCT02504671|144670134|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-4.8|15.6|||||Difference to placebo for Week 32 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||15.6|-4.8|
72570044|NCT02504671|144670134|OTHER||Difference|18.9|||||TWO_SIDED|95.0|4.7|33.2|||||Difference to placebo for Week 32 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||33.2|4.7|
72570045|NCT02504671|144670134|OTHER||Difference|18.9|||||TWO_SIDED|95.0|4.7|33.2|||||Difference to placebo for Week 32 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||33.2|4.7|
72570046|NCT02504671|144670134|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-4.8|15.6|||||Difference to placebo for Week 36 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||15.6|-4.8|
72570047|NCT02504671|144670134|OTHER||Difference|16.2|||||TWO_SIDED|95.0|2.6|29.9|||||Difference to placebo for Week 36 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||29.9|2.6|
72570048|NCT02504671|144670134|OTHER||Difference|18.9|||||TWO_SIDED|95.0|4.7|33.2|||||Difference to placebo for Week 36 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||33.2|4.7|
72570049|NCT02504671|144670134|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-4.8|15.6|||||Difference to placebo for Week 40 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||15.6|-4.8|
72570050|NCT02504671|144670134|OTHER||Difference|16.2|||||TWO_SIDED|95.0|2.6|29.9|||||Difference to placebo for Week 40 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||29.9|2.6|
72406004|NCT00653224|144320350|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.34|||<|0.001||95.0|-0.52|-0.17||If the p-value of this estimated difference is lower than 5% the mean change from baseline in overall RQLQ score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the change from baseline in overall RQLQ score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean change from baseline in overall RQLQ score at visit 4 (week 2) is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.17|-0.52|<0.001
72406005|NCT00653224|144320351|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.25||||0.042||95.0|-0.49|-0.01||If the p-value of this estimated difference is lower than 5% the mean change from baseline in RQLQ activities score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the change from baseline in RQLQ activities score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean change from baseline in RQLQ activities score at endpoint visit is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.01|-0.49|0.042
72406006|NCT00653224|144320352|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.29||||0.014||95.0|-0.52|-0.06||If the p-value of this estimated difference is lower than 5% the mean change from baseline in RQLQ activities score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the change from baseline in RQLQ activities score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean change from baseline in RQLQ activities score at visit 3 (week 1) is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.06|-0.52|0.014
72406007|NCT00653224|144320353|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.26||||0.036||95.0|-0.51|-0.02||If the p-value of this estimated difference is lower than 5% the mean change from baseline in RQLQ activities score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the change from baseline in RQLQ activities score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean change from baseline in RQLQ activities score at visit 4 (week 2) is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.02|-0.51|0.036
72521507|NCT00324272|144571901|SUPERIORITY_OR_OTHER|||||||0.988||95.0|||||t-test, 2 sided|||||||0.988
72521508|NCT00324272|144571901|SUPERIORITY_OR_OTHER|||||||0.426||95.0|||||t-test, 2 sided|||||||0.426
72521509|NCT00324272|144571902|SUPERIORITY_OR_OTHER|||||||0.351||95.0|||||Fisher Exact|||||||0.351
72521510|NCT00324272|144571902|SUPERIORITY_OR_OTHER|||||||0.48||95.0|||||Fisher Exact|||||||0.480
72521511|NCT00324272|144571903|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.002
72406008|NCT00653224|144320354|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.27||||0.01||95.0|-0.48|-0.07||If the p-value of this estimated difference is lower than 5% the mean change from baseline in RQLQ sleep score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the change from baseline in RQLQ sleep score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean change from baseline in RQLQ sleep score at endpoint visit is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.07|-0.48|0.010
72521512|NCT00324272|144571903|SUPERIORITY_OR_OTHER|||||||0.4||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.400
72521513|NCT00324272|144571904|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|||Local recurrence in the groin cohort.||||1.00
72521514|NCT00324272|144571904|SUPERIORITY_OR_OTHER|||||||0.301||95.0|||||Fisher Exact|||In transit or regional recurrence in the groin cohort.||||0.301
72521515|NCT00324272|144571904|SUPERIORITY_OR_OTHER|||||||0.474||95.0|||||Fisher Exact|||Distant metastasis in the groin cohort (with the patient being alive at the end of the study follow-up period on 1.6.10).||||0.474
72521516|NCT00324272|144571904|SUPERIORITY_OR_OTHER|||||||0.606||95.0|||||Fisher Exact|||Local recurrence in the groin cohort.||||0.606
72521517|NCT00324272|144571904|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|||In transit or regional recurrence in the axillary cohort.||||1.000
72570051|NCT02504671|144670134|OTHER||Difference|18.9|||||TWO_SIDED|95.0|4.7|33.2|||||Difference to placebo for Week 40 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||33.2|4.7|
72570052|NCT02504671|144670134|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-4.8|15.6|||||Difference to placebo for Week 48 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||15.6|-4.8|
72521518|NCT00324272|144571904|SUPERIORITY_OR_OTHER|||||||0.486||95.0|||||Fisher Exact|||Distant metastasis in the axillary cohort (with the patient being alive at the end of the study follow-up period on 1.6.10).||||0.486
72570053|NCT02504671|144670134|OTHER||Difference|16.2|||||TWO_SIDED|95.0|2.6|29.9|||||Difference to placebo for Week 48 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||29.9|2.6|
72570054|NCT02504671|144670134|OTHER||Difference|16.2|||||TWO_SIDED|95.0|2.6|29.9|||||Difference to placebo for Week 48 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||29.9|2.6|
72570055|NCT02504671|144670134|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-4.8|15.6|||||Difference to placebo for Week 52 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||15.6|-4.8|
72521519|NCT00324272|144571905|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.02||||0.963|TWO_SIDED|95.0|0.4|2.58|||Regression, Cox|||Death from metastatic disease in the groin cohort.||2.58|0.40|0.963
72521520|NCT00324272|144571905|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.33||||0.338|TWO_SIDED|95.0|0.03|3.2|||Regression, Cox|||Death from an unrelated cause in the groin cohort.||3.20|0.03|0.338
72521521|NCT00324272|144571905|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.93||||0.88|TWO_SIDED|95.0|0.35|2.47|||Regression, Cox|||Death from metastatic disease in the axillary cohort.||2.47|0.35|0.880
72521522|NCT00324272|144571905|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.923||||0.923|TWO_SIDED|95.0|0.05|13.95|||Regression, Cox|||Death from an unrelated cause in the axillary cohort.||13.95|0.05|0.923
72521523|NCT00371540|144571907|SUPERIORITY_OR_OTHER|||||||0.65|||||||Fisher Exact|||Note: The differences between the number of individuals evaluable for this secondary outcome and the number of individuals evaluable for the primary outcome is related to specimen loss by the laboratory. As such of the Routine care group only 96 of 102 patients completing the study were evaluable for the viral load outcome and only 86 of 87 patients in the Home visit group.||||0.65
72521524|NCT00371540|144571908|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||||||1.0
72521525|NCT00371540|144571909|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Fisher Exact|||||||<0.05
72521526|NCT01548417|144571910|SUPERIORITY_OR_OTHER|||||||0.003|||||||Mixed Models Analysis|||Linear Mixed Effects Modeling (MEM) with Restricted Maximum Likelihood estimation was used to measure differences in alcohol-cued craving..||||.003
72521527|NCT01548417|144571911|SUPERIORITY_OR_OTHER|||||||0.05|||||||Mixed Models Analysis|||Linear Mixed Effect Modeling (MEM) with Restricted Maximum Likelihood estimation was used to measure differences in changes in drinking.||||.05
72521528|NCT01548417|144571911|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Mixed Models Analysis|||Data represent the estimated marginal mean + or - SEM. \*P\<0.05, mifepristone vs. placebo (linear mixed effects modeling).||||<0.05
72521529|NCT04583969|144571915|SUPERIORITY||Odds Ratio (OR)|1.13||||0.691|TWO_SIDED|95.0|0.63|2.02|||Regression, Logistic||Odds ratio above 1 favors Remdesivir plus Lenzilumab.|Odds ratio, CI, and p-value estimated from a logistic regression model adjusted for baseline dexamethasone use, baseline OS, age (continuous), and baseline CRP. Missing data imputed using the 3-stage multiple imputation procedure described in the statistical analysis plan.||2.02|0.63|0.691
72521530|NCT04583969|144571916|SUPERIORITY||Odds Ratio (OR)|1.24||||0.378|TWO_SIDED|95.0|0.77|1.99|||Regression, Logistic||Odds ratio above 1 favors Remdesivir plus Lenzilumab.|Odds ratio, CI, and p-value estimated from a logistic regression model adjusted for baseline dexamethasone use, baseline OS, age (continuous), and baseline CRP. Missing data imputed using the 3-stage multiple imputation procedure described in the statistical analysis plan.||1.99|0.77|0.378
72521531|NCT04583969|144571917|SUPERIORITY|Hazard ratio, confidence intervals, and p-value estimated from a Cox model adjusted for baseline dexamethasone use, baseline ordinal score, age, and baseline CRP.|Hazard Ratio, log|0.96||||0.689|TWO_SIDED|95.0|0.76|1.2|||Regression, Cox||HR greater than 1 favors Remdesivir plus Lenzilumab.|||1.20|0.76|0.689
72521532|NCT04583969|144571918|SUPERIORITY||Hazard Ratio (HR)|0.96||||0.718|TWO_SIDED|95.0|0.79|1.18|||Regression, Cox||HR greater than 1 favors Remdesivir plus Lenzilumab.|Hazard ratio, confidence intervals, and p-value estimated from a Cox model adjusted for baseline dexamethasone use, baseline ordinal Score, age, and baseline CRP.||1.18|0.79|0.718
72521533|NCT04583969|144571919|SUPERIORITY||Odds Ratio (OR)|1.02||||0.907|TWO_SIDED|95.0|0.75|1.39|||Proportional odds model||Odds ratio greater than 1 favors Remdesivir plus Lenzilumab.|Includes all ordinal score categories. Odds ratio of a better clinical status score, confidence interval and p-value estimated from a proportional odds model adjusted for baseline steroid use and baseline ordinal score. Missing data imputed using multiple imputation (MI) for participants lost to follow-up before Day 8 while hospitalized, in hospice, long term acute care, or transferred to other hospital while those participants lost to follow-up after discharge to home are assigned a score of 2.||1.39|0.75|0.907
72625008|NCT03440385|144779536|SUPERIORITY||Odds Ratio (OR)|1.28||||0.403|TWO_SIDED|95.0|0.72|2.26|||Cochran-Mantel-Haenszel|Odds ratio and p-value are obtained using the CMH test stratified by corticosteroid use at baseline (yes or no), and prior biologic use (yes or no)||||2.26|0.72|0.4030
72625009|NCT03440385|144779537|SUPERIORITY||Odds Ratio (OR)|0.79||||0.563|TWO_SIDED|95.0|0.35|1.78|||Mantel Haenszel|Odds ratio, and p-value are obtained using the CMH test stratified by corticosteroid use at baseline (yes or no), and prior biologic use (yes or no).||||1.78|0.35|0.5630
72625010|NCT01765400|144779549|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<0.05
72521534|NCT04583969|144571953|SUPERIORITY||Hazard Ratio (HR)|1.05||||0.609|TWO_SIDED|95.0|0.87|1.27|||Regression, Cox||HR greater than 1 favors Remdesivir plus Lenzilumab|||1.27|0.87|0.609
72521535|NCT04583969|144571954|SUPERIORITY||Hazard Ratio (HR)|1.04||||0.708|TWO_SIDED|95.0|0.85|1.26|||Regression, Cox||HR greater than 1 favors Remdesivir plus Lenzilumab|||1.26|0.85|0.708
72521536|NCT02420990|144571985|SUPERIORITY||Slope|-0.31|||||TWO_SIDED||||||Latent Growth Curve Modeling|||||||
72521537|NCT02420990|144571985|SUPERIORITY||Slope|-0.67|||||TWO_SIDED||||||Latent Growth Curve Modeling|||||||
72521538|NCT02420990|144571985|SUPERIORITY||Slope|0.05||||0.05|TWO_SIDED||||||Latent Growth Curve Modeling|||||||0.05
72521539|NCT02420990|144571985|SUPERIORITY||Slope|0.56||||0.05|TWO_SIDED||||||Latent Growth Curve Modeling|||||||0.05
72521540|NCT02420990|144571985|SUPERIORITY||Slope|-0.72||||0.05|TWO_SIDED||||||Latent Growth Curve Modeling|||||||0.05
72521541|NCT02420990|144571986|SUPERIORITY||Slope|-1.78|||||TWO_SIDED||||||Linear Growth Curve Modeling|||||||
72521542|NCT02420990|144571986|SUPERIORITY||Slope|-0.64|||||TWO_SIDED||||||Latent Growth Curve Modeling|||||||
72521543|NCT02420990|144571986|SUPERIORITY||Slope|0.07|||||TWO_SIDED||||||Linear Growth Curve Modeling|||||||
72521544|NCT02420990|144571986|SUPERIORITY||Slope|0.0|||||TWO_SIDED||||||Latent Growth Curve Modeling|||||||
72521545|NCT02420990|144571986|SUPERIORITY||Slope|-1.44|||||TWO_SIDED||||||Latent Growth Curve Modeling|||||||
72521546|NCT02420990|144571987|SUPERIORITY||Mean Difference (Final Values)|6.6||||0.56|TWO_SIDED||||||Regression, Linear|||||||.56
72521547|NCT01525667|144571997|SUPERIORITY_OR_OTHER||Least Square Means (LSM) Difference|25.74|STANDARD_ERROR_OF_MEAN|8.94||0.0067|TWO_SIDED|95.0|7.61|43.86|||Mixed Models Analysis||LSM difference =LSM Low dose - LSM Placebo|||43.86|7.61|0.0067
72521548|NCT01525667|144571997|SUPERIORITY_OR_OTHER||Least Square Means (LSM) difference|14.93|STANDARD_ERROR_OF_MEAN|10.8||0.18|TWO_SIDED|95.0|-7.12|36.99|||Mixed Models Analysis||LSM difference= LSM High Dose - LSM Placebo|||36.99|-7.12|0.18
72521549|NCT01525667|144571998|SUPERIORITY_OR_OTHER||LSM Difference|18.03|STANDARD_ERROR_OF_MEAN|5.97||0.004|TWO_SIDED|95.0|6.03|30.02|||Mixed Models Analysis|||||30.02|6.03|0.004
72521550|NCT01525667|144571998|SUPERIORITY_OR_OTHER||LSM difference|9.23|STANDARD_ERROR_OF_MEAN|6.91||0.19|TWO_SIDED|95.0|-4.72|23.17|||Mixed Models Analysis|||||23.17|-4.72|0.19
72521551|NCT01525667|144571999|SUPERIORITY_OR_OTHER||LSM Difference|6.45|STANDARD_ERROR_OF_MEAN|4.64||0.19|TWO_SIDED|95.0|-3.5|16.41|||ANCOVA|||||16.41|-3.50|0.19
72521552|NCT01525667|144571999|SUPERIORITY_OR_OTHER||LSM difference|5.49|STANDARD_ERROR_OF_MEAN|4.56||0.25|TWO_SIDED|95.0|-4.29|15.26|||ANCOVA|||||15.26|-4.29|0.25
72406009|NCT00653224|144320355|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.23||||0.026||95.0|-0.43|-0.03||If the p-value of this estimated difference is lower than 5% the mean change from baseline in RQLQ sleep score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the change from baseline in RQLQ sleep score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean change from baseline in RQLQ sleep score at visit 3 (week 1) is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.03|-0.43|0.026
72406010|NCT00653224|144320356|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.25||||0.018||95.0|-0.45|-0.04||If the p-value of this estimated difference is lower than 5% the mean change from baseline in RQLQ sleep score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the change from baseline in RQLQ sleep score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean change from baseline in RQLQ sleep score at visit 4 (week 2) is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.04|-0.45|0.018
72406011|NCT00653224|144320357|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.29||||0.002||95.0|-0.47|-0.1||If the p-value of this estimated difference is lower than 5% the mean change from baseline in RQLQ non-nose/eye symptoms score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the change from baseline in RQLQ N-N/E symptoms score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as: 'The mean change from baseline in RQLQ non-nose/eye symptoms score at endpoint visit is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.10|-0.47|0.002
72406012|NCT00653224|144320358|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.24||||0.006||95.0|-0.41|-0.07||If the p-value of this estimated difference is lower than 5% the mean change from baseline in RQLQ non-nose/eye symptoms score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the change from baseline in RQLQ N-N/E symptoms score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean change from baseline in RQLQ non-nose/eye symptoms score at visit 3 (week 1) is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.07|-0.41|0.006
72406013|NCT00653224|144320359|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.28||||0.003||95.0|-0.47|-0.1||If the p-value of this estimated difference is lower than 5% the mean change from baseline in RQLQ non-nose/eye symptoms score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the change from baseline in RQLQ N-N/E symptoms score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean change from baseline in RQLQ non-nose/eye symptoms score at visit 4 (week 2) is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.10|-0.47|0.003
72521553|NCT01525667|144572000|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.16|STANDARD_ERROR_OF_MEAN|0.19||0.4|TWO_SIDED|95.0|-0.21|0.53|||Mixed Models Analysis|||||0.53|-0.21|0.4
72521554|NCT01525667|144572000|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.011|STANDARD_ERROR_OF_MEAN|0.2||0.96|TWO_SIDED||||||Mixed Models Analysis|||||||0.96
72521555|NCT01525667|144572001|SUPERIORITY_OR_OTHER||LSM difference|16.81|STANDARD_ERROR_OF_MEAN|8.37||0.05|TWO_SIDED|95.0|0.16|33.47|||Mixed Models Analysis|||||33.47|0.16|0.05
72521556|NCT01525667|144572001|SUPERIORITY_OR_OTHER||LSM difference|10.7|STANDARD_ERROR_OF_MEAN|9.01||0.24|TWO_SIDED|95.0|-7.26|28.65|||Mixed Models Analysis|||||28.65|-7.26|0.24
72521557|NCT01784614|144572007|SUPERIORITY_OR_OTHER||Ratio of Geometric LS mean|0.96||||0.908|TWO_SIDED|90.0|0.56|1.65|||Mixed Models Analysis||Ratio of Geometric LS mean is WASO of 0.1 mg LY2624803 / Placebo.|||1.65|0.56|0.908
72521558|NCT01784614|144572007|SUPERIORITY_OR_OTHER||Ratio of Geometric LS mean|0.67||||0.083|TWO_SIDED|90.0|0.45|0.98|||Mixed Models Analysis||Ratio of Geometric LS mean is WASO of 1.0 mg LY2624803 / Placebo.|||0.98|0.45|0.083
72521559|NCT01784614|144572007|SUPERIORITY_OR_OTHER||Ratio of Geometric LS mean|0.53||||0.01|TWO_SIDED|90.0|0.36|0.78|||Mixed Models Analysis||Ratio of Geometric LS mean is WASO of 3.0 mg LY2624803 / Placebo.|||0.78|0.36|0.010
72521560|NCT01784614|144572007|SUPERIORITY_OR_OTHER||Ratio of Geometric LS mean|0.3|||<|0.001|TWO_SIDED|90.0|0.18|0.51|||Mixed Models Analysis||Ratio of Geometric LS mean is WASO of 6.0 mg LY2624803 / Placebo.|||0.51|0.18|<0.001
72521561|NCT01484561|144572012|SUPERIORITY_OR_OTHER||Ratio of Adjusted Geo Mean-Fold Change|0.92|||||TWO_SIDED|90.0|0.86|0.98|||ANCOVA||Analysis of covariance (ANCOVA) with change in logarithmic mGFR from baseline as dependent variable, treatment and logarithmic baseline as covariate.|Ratio of adjusted geometric mean-fold Change (CP-690,550-placebo vs. placebo-placebo)||0.98|0.86|
72521562|NCT01484561|144572013|SUPERIORITY_OR_OTHER||Ratio of Adjusted Geo Mean-Fold Change|1.04|||||TWO_SIDED|90.0|0.97|1.11|||ANCOVA||ANCOVA with change in logarithmic mGFR from baseline as dependent variable, treatment and logarithmic baseline as covariate.|Ratio of adjusted geometric mean-fold change (CP-690,550-placebo vs. placebo-placebo)||1.11|0.97|
72521563|NCT01484561|144572014|SUPERIORITY_OR_OTHER||Ratio of Adjusted Geo Mean-Fold Change|1.09|||||TWO_SIDED|90.0|1.02|1.16|||ANCOVA||ANCOVA with change in logarithmic mGFR from Period 2 baseline/the end of Period 1 as dependent variable, treatment and logarithmic Period 2 baseline/the end of Period 1 as covariate.|Ratio of adjusted geometric mean-fold change (CP-690,550-placebo vs. placebo-placebo)||1.16|1.02|
72521564|NCT01484561|144572015|SUPERIORITY_OR_OTHER||Ratio of Adjusted Geo Mean-Fold Change|0.94|||||TWO_SIDED|90.0|0.91|0.97|||ANCOVA||ANCOVA with change in logarithmic eGFR (MDRD) from baseline as dependent variable, treatment and logarithmic baseline as covariate.|Ratio of adjusted geometric mean-fold change (CP-690,550-placebo vs. placebo-placebo)||0.97|0.91|
72570056|NCT02504671|144670134|OTHER||Difference|13.5|||||TWO_SIDED|95.0|0.5|26.5|||||Difference to placebo for Week 52 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||26.5|0.5|
72570057|NCT02504671|144670134|OTHER||Difference|13.5|||||TWO_SIDED|95.0|0.5|26.5|||||Difference to placebo for Week 52 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||26.5|0.5|
72521565|NCT01484561|144572016|SUPERIORITY_OR_OTHER||Ratio of Adjusted Geo Mean-Fold Change|0.99|||||TWO_SIDED|90.0|0.96|1.02|||ANCOVA||ANCOVA with change in logarithmic eGFR (MDRD) from baseline as dependent variable, treatment and logarithmic baseline as covariate.|Ratio of adjusted geometric mean-fold change (CP-690,550-placebo vs. placebo-placebo)||1.02|0.96|
72521566|NCT01484561|144572017|SUPERIORITY_OR_OTHER||Ratio of Adjusted Geo Mean-Fold Change|1.04|||||TWO_SIDED|90.0|1.0|1.08|||ANCOVA||ANCOVA with change in logarithmic eGFR (MDRD) from Period 2 baseline/end of Period 1 as dependent variable, treatment and logarithmic Period 2 baseline/end of Period 1 as covariate.|Ratio of adjusted geometric mean-fold change (CP-690,550-placebo vs. placebo-placebo)||1.08|1.00|
72521567|NCT01484561|144572018|SUPERIORITY_OR_OTHER||Ratio of Adjusted Geo Mean-Fold Change|0.95|||||TWO_SIDED|90.0|0.92|0.98|||ANCOVA||ANCOVA with change in logarithmic eGFR (Cockcroft-Gault) from baseline as dependent variable, treatment and logarithmic baseline as covariate.|Ratio of adjusted geometric mean-fold change (CP-690,550-placebo vs. placebo-placebo)||0.98|0.92|
72521568|NCT01484561|144572019|SUPERIORITY_OR_OTHER||Ratio of Adjusted Geo Mean-Fold Change|0.99|||||TWO_SIDED|90.0|0.97|1.02|||ANCOVA||ANCOVA with change in logarithmic eGFR (Cockcroft-Gault) from baseline as dependent variable, treatment and logarithmic baseline as covariate.|Ratio of adjusted geometric mean-fold change (CP-690,550-placebo vs. placebo-placebo)||1.02|0.97|
72521569|NCT01484561|144572020|SUPERIORITY_OR_OTHER||Ratio of Adjusted Geo Mean-Fold Change|1.04|||||TWO_SIDED|90.0|1.01|1.07|||ANCOVA||ANCOVA with change in logarithmic eGFR (Cockcroft-Gault) from Period 2 baseline/end of Period 1 as dependent variable, treatment and logarithmic Period 2 baseline/end of Period 1 as covariate.|Ratio of adjusted geometric mean-fold change (CP-690,550-placebo vs. placebo-placebo)||1.07|1.01|
72521570|NCT01484561|144572021|SUPERIORITY_OR_OTHER||Ratio of Adjusted Geo Mean-Fold Change|1.05|||||TWO_SIDED|90.0|1.02|1.08|||ANCOVA||ANCOVA with change in logarithmic creatinine from baseline as dependent variable, treatment and logarithmic baseline as covariate.|Ratio of adjusted geometric mean-fold change (CP-690,550-placebo vs. placebo-placebo)||1.08|1.02|
72521571|NCT01484561|144572022|SUPERIORITY_OR_OTHER||Ratio of Adjusted Geo Mean-Fold Change|1.01|||||TWO_SIDED|90.0|0.98|1.04|||ANCOVA||ANCOVA with change in logarithmic creatinine from baseline as dependent variable, treatment and logarithmic baseline as covariate.|Ratio of adjusted geometric mean-fold change (CP-690,550-placebo vs. placebo-placebo)||1.04|0.98|
72521572|NCT01484561|144572023|SUPERIORITY_OR_OTHER||Ratio of Adjusted Geo Mean-Fold Change|0.97|||||TWO_SIDED|90.0|0.94|1.0|||ANCOVA||ANCOVA with change in logarithmic creatinine from Period 2 baseline/the end of Period 1 as dependent variable, treatment and Period 2 baseline/the end of Period 1 as covariate.|Ratio of adjusted geometric mean-fold change (CP-690,550-placebo vs. placebo-placebo)||1.00|0.94|
72521573|NCT01484561|144572024|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|36.16|STANDARD_ERROR_OF_MEAN|7.64|<|0.001|TWO_SIDED|90.0|23.6|48.73||Two-sided test at 5% significance level.|Normal approximation for proportions|||Between-group difference in ACR20 Response at End of Period 1||48.73|23.60|<0.001
72521574|NCT01484561|144572024|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|15.95|STANDARD_ERROR_OF_MEAN|8.14||0.05|TWO_SIDED|90.0|2.56|29.34||Two-sided test at 5% significance level.|Normal approximation for proportions|||Between-group difference in ACR20 Response at End of Period 2||29.34|2.56|0.050
72521575|NCT01484561|144572025|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|21.02|STANDARD_ERROR_OF_MEAN|5.94|<|0.001|TWO_SIDED|90.0|11.24|30.8||Two-sided test at 5% significance level.|Normal approximation for proportions|||Between-group difference in ACR50 Response at End of Period 1||30.80|11.24|<0.001
72521576|NCT01484561|144572025|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|17.0|STANDARD_ERROR_OF_MEAN|6.13||0.006|TWO_SIDED|90.0|6.92|27.08||Two-sided test at 5% significance level.|Normal approximation for proportions|||Between-group difference in ACR50 Response at End of Period 2||27.08|6.92|0.006
72521577|NCT01484561|144572026|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|18.56|STANDARD_ERROR_OF_MEAN|3.95|<|0.001|TWO_SIDED|90.0|12.06|25.05||Two-sided test at 5% significance level.|Normal approximation for proportions|||Between-group difference in ACR70 Response at End of Period 1||25.05|12.06|<0.001
72521578|NCT01484561|144572026|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.32|STANDARD_ERROR_OF_MEAN|3.53||0.038|TWO_SIDED|90.0|1.51|13.12||Two-sided test at 5% significance level.|Normal approximation for proportions|||Between-group difference in ACR70 Response at End of Period 2||13.12|1.51|0.038
72521579|NCT01484561|144572027|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.16|STANDARD_ERROR_OF_MEAN|0.23|<|0.001|TWO_SIDED|90.0|-1.53|-0.78||Two-sided test at 5% significance level.|Mixed Models Analysis||Linear mixed-effects model for longitudinal data was used with actual value as dependent variable, treatment group, visit (baseline, end of Period 1, end of Period 2), treatment group by visit interaction as fixed effect, participant as random effect|||-0.78|-1.53|<0.001
72521580|NCT01484561|144572028|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.47|STANDARD_ERROR_OF_MEAN|0.21||0.028|TWO_SIDED|90.0|-0.83|-0.12||Two-sided test at 5% significance level.|Mixed Models Analysis||Linear mixed-effects model for longitudinal data was used with actual value as dependent variable, treatment group, visit (baseline, end of Period 1, end of Period 2), treatment group by visit interaction as fixed effect, participant as random effect|||-0.12|-0.83|0.028
72521581|NCT01484561|144572029|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.68|STANDARD_ERROR_OF_MEAN|0.22||0.002|TWO_SIDED|90.0|0.32|1.04||Two-sided test at 5% significance level.|Mixed Models Analysis||Linear mixed-effects model for longitudinal data was used with actual value as dependent variable, treatment group, visit (baseline, end of Period 1, end of Period 2), treatment group by visit interaction as fixed effect, participant as random effect|||1.04|0.32|0.002
72521582|NCT01484561|144572030|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.26|STANDARD_ERROR_OF_MEAN|0.25|<|0.001|TWO_SIDED|90.0|-1.67|-0.84||Two-sided test at 5% significance level.|Mixed Models Analysis||Linear mixed-effects model for longitudinal data was used with actual value as dependent variable, treatment group, visit (baseline, end of Period 1, end of Period 2), treatment group by visit interaction as fixed effect, participant as random effect|||-0.84|-1.67|<0.001
72570058|NCT02504671|144670134|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-6.3|11.7|||||Difference to placebo for Week 62 (follow-up) is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||11.7|-6.3|
72570059|NCT02504671|144670134|OTHER||Difference|13.5|||||TWO_SIDED|95.0|0.5|26.5|||||Difference to placebo for Week 62 (follow-up) is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||26.5|0.5|
72521583|NCT01484561|144572031|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|0.23||0.031|TWO_SIDED|90.0|-0.88|-0.12||Two-sided test at 5% significance level.|Mixed Models Analysis||Linear mixed-effects model for longitudinal data was used with actual value as dependent variable, treatment group, visit (baseline, end of Period 1, end of Period 2), treatment group by visit interaction as fixed effect, participant as random effect|||-0.12|-0.88|0.031
72521584|NCT01484561|144572032|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.76|STANDARD_ERROR_OF_MEAN|0.24||0.002|TWO_SIDED|90.0|0.36|1.15||Two-sided test at 5% significance level.|Mixed Models Analysis||Linear mixed-effects model for longitudinal data was used with actual value as dependent variable, treatment group, visit (baseline, end of Period 1, end of Period 2), treatment group by visit interaction as fixed effect, participant as random effect|||1.15|0.36|0.002
72521585|NCT01484561|144572033|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.09|STANDARD_ERROR_OF_MEAN|2.02||0.045|TWO_SIDED|90.0|-7.44|-0.74||Two-sided test at 5% significance level.|Mixed Models Analysis||Linear mixed-effects model for longitudinal data was used with actual value as dependent variable, treatment group, visit (baseline, end of Period 1, end of Period 2), treatment group by visit interaction as fixed effect, participant as random effect|||-0.74|-7.44|0.045
72521586|NCT01484561|144572034|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.14|STANDARD_ERROR_OF_MEAN|1.76||0.936|TWO_SIDED|90.0|-2.78|3.06||Two-sided test at 5% significance level.|Mixed Models Analysis||Linear mixed-effects model for longitudinal data was used with actual value as dependent variable, treatment group, visit (baseline, end of Period 1, end of Period 2), treatment group by visit interaction as fixed effect, participant as random effect|||3.06|-2.78|0.936
72521587|NCT01484561|144572035|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.23|STANDARD_ERROR_OF_MEAN|1.93||0.03|TWO_SIDED|90.0|1.04|7.42||Two-sided test at 5% significance level.|Mixed Models Analysis||Linear mixed-effects model for longitudinal data was used with actual value as dependent variable, treatment group, visit (baseline, end of Period 1, end of Period 2), treatment group by visit interaction as fixed effect, participant as random effect|||7.42|1.04|0.030
72521588|NCT01484561|144572036|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.26|STANDARD_ERROR_OF_MEAN|1.03||0.03|TWO_SIDED|90.0|-3.96|-0.55||Two-sided test at 5% significance level.|Mixed Models Analysis||Linear mixed-effects model for longitudinal data was used with actual value as dependent variable, treatment group, visit (baseline, end of Period 1, end of Period 2), treatment group by visit interaction as fixed effect, participant as random effect|||-0.55|-3.96|0.030
72521589|NCT01484561|144572037|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8|STANDARD_ERROR_OF_MEAN|1.11||0.472|TWO_SIDED|90.0|-2.64|1.04||Two-sided test at 5% significance level.|Mixed Models Analysis||Linear mixed-effects model for longitudinal data was used with actual value as dependent variable, treatment group, visit (baseline, end of Period 1, end of Period 2), treatment group by visit interaction as fixed effect, participant as random effect|||1.04|-2.64|0.472
72521590|NCT01484561|144572038|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.46|STANDARD_ERROR_OF_MEAN|1.03||0.158|TWO_SIDED|90.0|-0.24|3.15||Two-sided test at 5% significance level.|Mixed Models Analysis||Linear mixed-effects model for longitudinal data was used with actual value as dependent variable, treatment group, visit (baseline, end of Period 1, end of Period 2), treatment group by visit interaction as fixed effect, participant as random effect|||3.15|-0.24|0.158
72521591|NCT01484561|144572039|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.73|STANDARD_ERROR_OF_MEAN|3.71|<|0.001|TWO_SIDED|90.0|-19.87|-7.59||Two-sided test at 5% significance level.|Mixed Models Analysis||Linear mixed-effects model for longitudinal data was used with actual value as dependent variable, treatment group, visit (baseline, end of Period 1, end of Period 2), treatment group by visit interaction as fixed effect, participant as random effect|||-7.59|-19.87|<0.001
72521592|NCT01484561|144572040|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.89|STANDARD_ERROR_OF_MEAN|4.04||0.029|TWO_SIDED|90.0|-15.58|-2.21||Two-sided test at 5% significance level.|Mixed Models Analysis||Linear mixed-effects model for longitudinal data was used with actual value as dependent variable, treatment group, visit (baseline, end of Period 1, end of Period 2), treatment group by visit interaction as fixed effect, participant as random effect|||-2.21|-15.58|0.029
72521593|NCT01484561|144572041|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.84|STANDARD_ERROR_OF_MEAN|2.98||0.107|TWO_SIDED|90.0|-0.1|9.77||Two-sided test at 5% significance level.|Mixed Models Analysis||Linear mixed-effects model for longitudinal data was used with actual value as dependent variable, treatment group, visit (baseline, end of Period 1, end of Period 2), treatment group by visit interaction as fixed effect, participant as random effect|||9.77|-0.10|0.107
72521594|NCT01484561|144572042|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.9|STANDARD_ERROR_OF_MEAN|4.87||0.001|TWO_SIDED|90.0|-23.96|-7.84||Two-sided test at 5% significance level.|Mixed Models Analysis||Linear mixed-effects model for longitudinal data was used with actual value as dependent variable, treatment group, visit (baseline, end of Period 1, end of Period 2), treatment group by visit interaction as fixed effect, participant as random effect|||-7.84|-23.96|0.001
72521595|NCT01484561|144572043|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.7|STANDARD_ERROR_OF_MEAN|4.95||0.251|TWO_SIDED|90.0|-13.9|2.5||Two-sided test at 5% significance level.|Mixed Models Analysis||Linear mixed-effects model for longitudinal data was used with actual value as dependent variable, treatment group, visit (baseline, end of Period 1, end of Period 2), treatment group by visit interaction as fixed effect, participant as random effect|||2.50|-13.90|0.251
72521596|NCT01484561|144572044|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.19|STANDARD_ERROR_OF_MEAN|4.42||0.023|TWO_SIDED|90.0|2.87|17.52||Two-sided test at 5% significance level.|Mixed Models Analysis||Linear mixed-effects model for longitudinal data was used with actual value as dependent variable, treatment group, visit (baseline, end of Period 1, end of Period 2), treatment group by visit interaction as fixed effect, participant as random effect|||17.52|2.87|0.023
72570060|NCT02504671|144670134|OTHER||Difference|13.5|||||TWO_SIDED|95.0|0.5|26.5|||||Difference to placebo for Week 62 (follow-up) is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||26.5|0.5|
72570061|NCT02504671|144670134|OTHER||Difference|13.5|||||TWO_SIDED|95.0|-1.1|28.1|||||Difference to placebo for Week 1 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||28.1|-1.1|
72570062|NCT02504671|144670134|OTHER||Difference|21.6|||||TWO_SIDED|95.0|5.6|37.7|||||Difference to placebo for Week 1 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||37.7|5.6|
72570063|NCT02504671|144670134|OTHER||Difference|18.9|||||TWO_SIDED|95.0|0.2|37.6|||||Difference to placebo for Week 2 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||37.6|0.2|
72570064|NCT02504671|144670134|OTHER||Difference|24.3|||||TWO_SIDED|95.0|5.2|43.4|||||Difference to placebo for Week 2 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||43.4|5.2|
72570065|NCT02504671|144670134|OTHER||Difference|27.0|||||TWO_SIDED|95.0|7.1|46.9|||||Difference to placebo for Week 4 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||46.9|7.1|
72625011|NCT02989857|144779552|SUPERIORITY||Hazard Ratio (HR)|0.37|||<|0.0001|TWO_SIDED|95.0|0.25|0.54||P-value was calculated from the one-sided stratified log-rank test.|Log Rank||Hazard ratio was calculated from stratified Cox regression model with placebo as the denominator, with two-sided 95% confidence interval.|||0.54|0.25|<0.0001
72625012|NCT02989857|144779559|SUPERIORITY||Hazard Ratio (HR)|0.79||||0.093|TWO_SIDED|95.0|0.56|1.12||P-value was calculated from the one-sided stratified log-rank test. Stratification factor was the number of prior line of therapies at randomization.|Log Rank||Hazard ratio was calculated from the stratified Cox regression model with placebo as the comparator, with two-sided 95% CI. Stratification factor was the number of prior line of therapies at randomization.|||1.12|0.56|0.093
72521597|NCT01484561|144572045|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.12|STANDARD_ERROR_OF_MEAN|3.9|<|0.001|TWO_SIDED|90.0|-21.58|-8.67||Two-sided test at 5% significance level.|Mixed Models Analysis||Linear mixed-effects model for longitudinal data was used with actual value as dependent variable, treatment group, visit (baseline, end of Period 1, end of Period 2), treatment group by visit interaction as fixed effect, participant as random effect|||-8.67|-21.58|<0.001
72521598|NCT01484561|144572046|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.4|STANDARD_ERROR_OF_MEAN|4.77||0.616|TWO_SIDED|90.0|-10.3|5.5||Two-sided test at 5% significance level.|Mixed Models Analysis||Linear mixed-effects model for longitudinal data was used with actual value as dependent variable, treatment group, visit (baseline, end of Period 1, end of Period 2), treatment group by visit interaction as fixed effect, participant as random effect|||5.50|-10.30|0.616
72521599|NCT01484561|144572047|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.72|STANDARD_ERROR_OF_MEAN|4.17||0.003|TWO_SIDED|90.0|5.82|19.62||Two-sided test at 5% significance level.|Mixed Models Analysis||Linear mixed-effects model for longitudinal data was used with actual value as dependent variable, treatment group, visit (baseline, end of Period 1, end of Period 2), treatment group by visit interaction as fixed effect, participant as random effect|||19.62|5.82|0.003
72521600|NCT01484561|144572048|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.3|STANDARD_ERROR_OF_MEAN|4.52|<|0.001|TWO_SIDED|90.0|-22.78|-7.82||Two-sided test at 5% significance level.|Mixed Models Analysis||Linear mixed-effects model for longitudinal data was used with actual value as dependent variable, treatment group, visit (baseline, end of Period 1, end of Period 2), treatment group by visit interaction as fixed effect, participant as random effect|||-7.82|-22.78|<0.001
72521601|NCT01484561|144572049|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.62|STANDARD_ERROR_OF_MEAN|4.83||0.247|TWO_SIDED|90.0|-13.62|2.38||Two-sided test at 5% significance level.|Mixed Models Analysis||Linear mixed-effects model for longitudinal data was used with actual value as dependent variable, treatment group, visit (baseline, end of Period 1, end of Period 2), treatment group by visit interaction as fixed effect, participant as random effect|||2.38|-13.62|0.247
72521602|NCT01484561|144572050|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.68|STANDARD_ERROR_OF_MEAN|4.67||0.04|TWO_SIDED|90.0|1.95|17.41||Two-sided test at 5% significance level.|Mixed Models Analysis||Linear mixed-effects model for longitudinal data was used with actual value as dependent variable, treatment group, visit (baseline, end of Period 1, end of Period 2), treatment group by visit interaction as fixed effect, participant as random effect|||17.41|1.95|0.040
72521603|NCT01484561|144572051|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.39|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|90.0|-0.56|-0.23||Two-sided test at 5% significance level.|Mixed Models Analysis||Linear mixed-effects model for longitudinal data was used with actual value as dependent variable, treatment group, visit (baseline, end of Period 1, end of Period 2), treatment group by visit interaction as fixed effect, participant as random effect|||-0.23|-0.56|<0.001
72570066|NCT02504671|144670134|OTHER||Difference|51.4|||||TWO_SIDED|95.0|32.2|70.5|||||Difference to placebo for Week 4 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||70.5|32.2|
72570067|NCT02504671|144670134|OTHER||Difference|21.6|||||TWO_SIDED|95.0|0.4|42.8|||||Difference to placebo for Week 6 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||42.8|0.4|
72570068|NCT02504671|144670134|OTHER||Difference|40.5|||||TWO_SIDED|95.0|19.9|61.2|||||Difference to placebo for Week 6 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||61.2|19.9|
72570069|NCT02504671|144670134|OTHER||Difference|27.0|||||TWO_SIDED|95.0|5.2|48.9|||||Difference to placebo for Week 8 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||48.9|5.2|
72570070|NCT02504671|144670134|OTHER||Difference|35.1|||||TWO_SIDED|95.0|13.8|56.5|||||Difference to placebo for Week 8 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||56.5|13.8|
72570071|NCT02504671|144670134|OTHER||Difference|27.0|||||TWO_SIDED|95.0|6.2|47.9|||||Difference to placebo for Week 12 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||47.9|6.2|
72570072|NCT02504671|144670134|OTHER||Difference|54.1|||||TWO_SIDED|95.0|34.9|73.2|||||Difference to placebo for Week 12 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||73.2|34.9|
72570073|NCT02504671|144670134|OTHER||Difference|21.6|||||TWO_SIDED|95.0|0.9|42.4|||||Difference to placebo for Week 16 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||42.4|0.9|
72570074|NCT02504671|144670134|OTHER||Difference|51.4|||||TWO_SIDED|95.0|31.8|70.9|||||Difference to placebo for Week 16 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||70.9|31.8|
72570075|NCT02504671|144670134|OTHER||Difference|27.0|||||TWO_SIDED|95.0|7.1|46.9|||||Difference to placebo for Week 20 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||46.9|7.1|
72570076|NCT02504671|144670134|OTHER||Difference|56.8|||||TWO_SIDED|95.0|38.2|75.4|||||Difference to placebo for Week 20 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||75.4|38.2|
72521604|NCT01484561|144572052|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.17|STANDARD_ERROR_OF_MEAN|0.09||0.053|TWO_SIDED|90.0|-0.31|-0.03||Two-sided test at 5% significance level.|Mixed Models Analysis||Linear mixed-effects model for longitudinal data was used with actual value as dependent variable, treatment group, visit (baseline, end of Period 1, end of Period 2), treatment group by visit interaction as fixed effect, participant as random effect|||-0.03|-0.31|0.053
72521605|NCT01484561|144572053|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.22|STANDARD_ERROR_OF_MEAN|0.07||0.003|TWO_SIDED|90.0|0.1|0.35||Two-sided test at 5% significance level.|Mixed Models Analysis||Linear mixed-effects model for longitudinal data was used with actual value as dependent variable, treatment group, visit (baseline, end of Period 1, end of Period 2), treatment group by visit interaction as fixed effect, participant as random effect|||0.35|0.10|0.003
72521606|NCT03371251|144572055|SUPERIORITY||Observed Difference vs. Placebo|2.0||||0.8434|TWO_SIDED|90.0|-14.5|18.5|||Pearson's chi-square test|||Statistical Analysis: SRI-4 Response||18.5|-14.5|0.8434
72521607|NCT03371251|144572055|SUPERIORITY||Observed Difference vs. Placebo|2.0||||0.8434|TWO_SIDED|90.0|-14.5|18.5|||Pearson's chi-square test|||Statistical Analysis: \>= 4-Point Reduction from Baseline in SLEDAI-2K Global Score||18.5|-14.5|0.8434
72521608|NCT03371251|144572055|SUPERIORITY||Observed Difference vs. Placebo|17.7||||0.0141|TWO_SIDED|90.0|4.5|30.9|||Pearson's chi-square test|||Statistical Analysis: No New BILAG A or More than One BILAG B Organ Score Compared with Baseline||30.9|4.5|0.0141
72521609|NCT03371251|144572055|SUPERIORITY||Observed Difference vs. Placebo|17.7||||0.0141|TWO_SIDED|90.0|4.5|30.9|||Pearson's chi-square test|||Statistical Analysis: No Deterioration from Baseline in PGA by \>=30mm||30.9|4.5|0.0141
72521610|NCT03371251|144572071|SUPERIORITY||Observed Difference vs. Placebo|-2.6||||0.7985|TWO_SIDED|90.0|-19.8|14.5|||Pearson's chi-square test|||||14.5|-19.8|0.7985
72521611|NCT03371251|144572072|SUPERIORITY||Observed Difference vs. Placebo|-6.9||||0.3498|TWO_SIDED|90.0|-22.9|9.8|||Pearson's chi-square test|||Statistical Analysis for Overall||9.8|-22.9|0.3498
72521612|NCT03371251|144572073|SUPERIORITY||Observed Difference vs. Placebo|-21.8||||0.0072|TWO_SIDED|90.0|-36.2|-7.4|||Pearson's chi-square test|||Statistical analysis for Overall||-7.4|-36.2|0.0072
72570077|NCT02504671|144670134|OTHER||Difference|27.0|||||TWO_SIDED|95.0|7.1|46.9|||||Difference to placebo for Week 24 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||46.9|7.1|
72625013|NCT02989857|144779560|SUPERIORITY|||||||0.466||||||P-value was calculated from 1-sided Fisher exact test.|Fisher Exact|||||||0.466
72521613|NCT03371251|144572073|SUPERIORITY||Observed Difference vs. Placebo|-17.7||||0.0141|TWO_SIDED|90.0|-30.9|-4.5|||Pearson's chi-square test|||Statistical Analysis for Day 210||-4.5|-30.9|0.0141
72521614|NCT03371251|144572074|SUPERIORITY||Observed Difference vs. Placebo|4.9||||0.6107|TWO_SIDED|90.0|-10.7|20.5|||Pearson's chi-square test|||||20.5|-10.7|0.6107
72521615|NCT03371251|144572075|SUPERIORITY||Observed Difference vs. Placebo|15.4||||0.1237|TWO_SIDED|90.0|-0.9|31.8|||Pearson's chi-square test|||||31.8|-0.9|0.1237
72521616|NCT03371251|144572076|SUPERIORITY||Observed Difference vs. Placebo|-13.7||||0.0581|TWO_SIDED|90.0|-26.7|-0.7|||Pearson's chi-square test|||Statistical Analysis for Overall||-0.7|-26.7|0.0581
72521617|NCT03371251|144572076|SUPERIORITY||Observed Difference vs. Placebo|-14.3||||0.0471|TWO_SIDED|90.0|-31.2|3.2|||Pearson's chi-square test|||Statistical Analysis for Day 210||3.2|-31.2|0.0471
72521618|NCT03371251|144572077|SUPERIORITY||Treatment Difference (BOS161721-Placebo)|-0.3|STANDARD_ERROR_OF_MEAN|0.78||0.6596|TWO_SIDED|90.0|-1.63|0.94|||ANCOVA||This is based on LS Means|Statistical Analysis for CLASI-A (Total Activity)||0.94|-1.63|0.6596
72521619|NCT03371251|144572077|SUPERIORITY||Treatment Difference (BOS161721-Placebo)|0.3|STANDARD_ERROR_OF_MEAN|0.33||0.4105|TWO_SIDED|90.0|-0.27|0.81|||ANCOVA||This is based on LS Means|Statistical Analysis for CLASI-B (Total Damage)||0.81|-0.27|0.4105
72521620|NCT03371251|144572078|SUPERIORITY||Treatment Difference (BOS161721-Placebo)|0.8|STANDARD_ERROR_OF_MEAN|4.11||0.8546|TWO_SIDED|90.0|-6.07|7.58|||ANCOVA||This is based on LS Means|Statistical Analysis for Day 210||7.58|-6.07|0.8546
72521621|NCT03371251|144572079|SUPERIORITY||Treatment Difference (BOS161721-Placebo)|0.5|STANDARD_ERROR_OF_MEAN|0.7||0.4455|TWO_SIDED|90.0|-0.63|1.71|||ANCOVA||This is based on LS Means|Statistical Analysis for Sum of Swelling for Day 210||1.71|-0.63|0.4455
72521622|NCT03371251|144572079|SUPERIORITY||Treatment Difference (BOS161721-Placebo)|0.9|STANDARD_ERROR_OF_MEAN|0.94||0.3367|TWO_SIDED|90.0|-0.65|2.47|||ANCOVA||This is based on LS Means|Statistical Analysis for Sum of Tenderness for Day 210||2.47|-0.65|0.3367
72521623|NCT03371251|144572079|SUPERIORITY||Treatment Difference (BOS161721-Placebo)|0.8|STANDARD_ERROR_OF_MEAN|0.66||0.255|TWO_SIDED|90.0|-0.34|1.86|||ANCOVA||This is based on LS Means|Statistical Analysis for Sum of Active Joints for Day 210||1.86|-0.34|0.2550
72521624|NCT03371251|144572080|SUPERIORITY||Treatment Difference (BOS161721-Placebo)|0.8|STANDARD_ERROR_OF_MEAN|0.68||0.2498|TWO_SIDED|90.0|-0.34|1.93|||ANCOVA||This is based on LS Means|||1.93|-0.34|0.2498
72521625|NCT03371251|144572081|SUPERIORITY||Treatment Difference (BOS161721-Placebo)|0.0|STANDARD_ERROR_OF_MEAN|0.04||0.2558|TWO_SIDED|90.0|-0.02|0.12|||ANCOVA||This is based on LS Means|Statistical Analysis for Day 180||0.12|-0.02|0.2558
72521626|NCT03371251|144572082|SUPERIORITY||Hazard Ratio (HR)|0.39||||0.0479|TWO_SIDED|90.0|0.18|0.88|||Log Rank||Hazard rate of BOS161721 120 mg / Hazard rate of placebo|||0.88|0.18|0.0479
72521627|NCT03371251|144572084|SUPERIORITY||Treatment Difference (BOS161721-Placebo)|4.4|STANDARD_ERROR_OF_MEAN|16.4||0.7898|TWO_SIDED|90.0|-22.92|31.7|||ANOVA||This is based on LS Means|||31.70|-22.92|0.7898
72521628|NCT03371251|144572085|SUPERIORITY||Hazard Ratio (HR)|0.33||||0.0083|TWO_SIDED|90.0|0.16|0.68|||Log-Rank Test (2-Sided)||Hazard rate of BOS161721 120mg / Hazard rate of placebo|||0.68|0.16|0.0083
72570078|NCT02504671|144670134|OTHER||Difference|54.1|||||TWO_SIDED|95.0|35.1|73.0|||||Difference to placebo for Week 24 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||73.0|35.1|
72570079|NCT02504671|144670134|OTHER||Difference|13.5|||||TWO_SIDED|95.0|0.5|26.5|||||Difference to placebo for Week 28 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||26.5|0.5|
72570080|NCT02504671|144670134|OTHER||Difference|75.7|||||TWO_SIDED|95.0|61.4|89.9|||||Difference to placebo for Week 28 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||89.9|61.4|
72625014|NCT02989857|144779561|SUPERIORITY|||||||0.299||||||P-value was calculated from 1-sided Fisher exact test.|Fisher Exact|||||||0.299
72570081|NCT02504671|144670134|OTHER||Difference|13.5|||||TWO_SIDED|95.0|0.5|26.5|||||Difference to placebo for Week 32 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||26.5|0.5|
72570082|NCT02504671|144670134|OTHER||Difference|70.3|||||TWO_SIDED|95.0|55.0|85.5|||||Difference to placebo for Week 32 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||85.5|55.0|
72570083|NCT02504671|144670134|OTHER||Difference|13.5|||||TWO_SIDED|95.0|0.5|26.5|||||Difference to placebo for Week 36 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||26.5|0.5|
72570084|NCT02504671|144670134|OTHER||Difference|70.3|||||TWO_SIDED|95.0|55.0|85.5|||||Difference to placebo for Week 36 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||85.5|55.0|
72570085|NCT02504671|144670134|OTHER||Difference|13.5|||||TWO_SIDED|95.0|0.5|26.5|||||Difference to placebo for Week 40 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||26.5|0.5|
72570086|NCT02504671|144670134|OTHER||Difference|62.2|||||TWO_SIDED|95.0|45.9|78.4|||||Difference to placebo for Week 40 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||78.4|45.9|
72570087|NCT02504671|144670134|OTHER||Difference|13.5|||||TWO_SIDED|95.0|0.5|26.5|||||Difference to placebo for Week 44 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||26.5|0.5|
72570088|NCT02504671|144670134|OTHER||Difference|56.8|||||TWO_SIDED|95.0|40.1|73.4|||||Difference to placebo for Week 44 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||73.4|40.1|
72570089|NCT02504671|144670134|OTHER||Difference|13.5|||||TWO_SIDED|95.0|0.5|26.5|||||Difference to placebo for Week 48 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||26.5|0.5|
72625015|NCT02989857|144779566|SUPERIORITY||Hazard Ratio (HR)|0.47|||<|0.0001|TWO_SIDED|95.0|0.33|0.68||P-value was calculated from one-sided stratified log-rank test. Stratification factor was the number of prior line of therapies at randomization.|Log Rank||Hazard ratio was calculated from the stratified Cox regression model with placebo as the denominator, with two-sided 95% CI. Stratification factor was the number of prior line of therapies at randomization.|||0.68|0.33|<0.0001
72570090|NCT02504671|144670134|OTHER||Difference|62.2|||||TWO_SIDED|95.0|45.9|78.4|||||Difference to placebo for Week 48 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||78.4|45.9|
72570091|NCT02504671|144670134|OTHER||Difference|13.5|||||TWO_SIDED|95.0|0.5|26.5|||||Difference to placebo for Week 52 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||26.5|0.5|
72570092|NCT02504671|144670134|OTHER||Difference|48.6|||||TWO_SIDED|95.0|31.7|65.6|||||Difference to placebo for Week 52 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||65.6|31.7|
72570093|NCT02504671|144670134|OTHER||Difference|13.5|||||TWO_SIDED|95.0|0.5|26.5|||||Difference to placebo for Week 62 (follow-up) is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||26.5|0.5|
72570094|NCT02504671|144670134|OTHER||Difference|51.4|||||TWO_SIDED|95.0|34.5|68.2|||||Difference to placebo for Week 62 (follow-up) is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||68.2|34.5|
72570095|NCT02504671|144670135|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||Week 1, ACR20. Difference to Placebo for Week 1 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
72570096|NCT02504671|144670135|OTHER||Difference|8.1|||||TWO_SIDED|95.0|-0.7|16.9|||||Week 1, ACR20. Difference to Placebo for Week 1 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||16.9|-0.7|
72570097|NCT02504671|144670135|OTHER||Difference|10.8|||||TWO_SIDED|95.0|0.8|20.8|||||Week 1, ACR20. Difference to Placebo for Week 1 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||20.8|0.8|
72570098|NCT02504671|144670135|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||Week 1, ACR50. Difference to Placebo for Week 1 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
72570099|NCT02504671|144670135|OTHER||Difference|13.5|||||TWO_SIDED|95.0|-1.1|28.1|||||Week 2, ACR20. Difference to Placebo for Week 2 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||28.1|-1.1|
72570100|NCT02504671|144670135|OTHER||Difference|8.1|||||TWO_SIDED|95.0|-5.1|21.3|||||Week 2, ACR20. Difference to Placebo for Week 2 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||21.3|-5.1|
72570101|NCT02504671|144670135|OTHER||Difference|10.8|||||TWO_SIDED|95.0|-3.1|24.7|||||Week 2, ACR20. Difference to Placebo for Week 2 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||24.7|-3.1|
72570102|NCT02504671|144670135|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||Week 2, ACR50. Difference to Placebo for Week 2 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
72570103|NCT02504671|144670135|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||Week 2, ACR50. Difference to Placebo for Week 2 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
72570104|NCT02504671|144670135|OTHER||Difference|8.1|||||TWO_SIDED|95.0|-0.7|16.9|||||Week 2, ACR50. Difference to Placebo for Week 2 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||16.9|-0.7|
72570105|NCT02504671|144670135|OTHER||Difference|16.2|||||TWO_SIDED|95.0|-0.2|32.6|||||Week 4, ACR20. Difference to Placebo for Week 4 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||32.6|-0.2|
72570106|NCT02504671|144670135|OTHER||Difference|27.0|||||TWO_SIDED|95.0|9.3|44.7|||||Week 4, ACR20. Difference to Placebo for Week 4 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||44.7|9.3|
72570107|NCT02504671|144670135|OTHER||Difference|24.3|||||TWO_SIDED|95.0|6.9|41.8|||||Week 4, ACR20. Difference to Placebo for Week 4 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||41.8|6.9|
72369315|NCT00611026|144248569|SUPERIORITY_OR_OTHER|||||||0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|P-value was obtained from a Cochran-Mantel-Haenszel test (CMH) with modified ridit scoring and stratified by country.||Treatment difference Tolterodine ER vs placebo at Week 4.||||0.0001
72521629|NCT04445688|144572088|SUPERIORITY||difference in Least Squares Mean|-7.3|||<|0.0001|TWO_SIDED|95.0|-10.2|-4.4|||ANOVA|||||-4.4|-10.2|<0.0001
72521630|NCT04445688|144572089|SUPERIORITY||difference in Least Squares Mean|-21.8|||<|0.0001|TWO_SIDED|95.0|-29.5|-14.1|||ANOVA|||||-14.1|-29.5|<0.0001
72521631|NCT04445688|144572090|SUPERIORITY||difference in Least Squares Mean|-7.3|||<|0.0001|TWO_SIDED|95.0|-10.5|-4.2|||ANOVA|||||-4.2|-10.5|<0.0001
72521632|NCT01262599|144572091|SUPERIORITY|Applies to primary and secondary outcomes: Data were analyzed using one-way analysis of variance, one-way repeated measures analysis of variance, t test, or Mann-Whitney rank sum test, as appropriate. (SigmaStat 3.5; Systat Software, Inc., San Jose, Calif.). Intention-to-treat using last value carried forward was used for missing data.|||||<|0.01|||||||ANOVA|||Before the start of this study, a sample size analysis, assuming a clinically meaningful 50± 40 percent (mean ± SD) decrease in pain scores from pulsed electromagnetic field treatment, suggested that a minimum of 11 patients per group were needed.||||<0.01
72521633|NCT01998399|144572094|SUPERIORITY_OR_OTHER|||||||0.41|TWO_SIDED||||||Chi-squared|||Total enrollment only 25 patients and the study was terminated early due to low enrollment. No further statistical analysis was done.||||0.41
72521634|NCT01269047|144572108|OTHER||Mean Difference (Final Values)|-2.2|STANDARD_DEVIATION|2.4||0.04|TWO_SIDED|95.0|-4.2|-0.2|||ANOVA|||||-0.2|-4.2|0.04
72521635|NCT01269047|144572108|OTHER||Mean Difference (Final Values)|-3.5|STANDARD_DEVIATION|2.7||0.008|TWO_SIDED|95.0|-5.8|-1.3|||ANOVA|||||-1.3|-5.8|0.008
72521636|NCT01269047|144572108|OTHER||Mean Difference (Final Values)|-4.2|STANDARD_DEVIATION|2.6||0.003|TWO_SIDED|95.0|-6.4|-2.0|||ANOVA|||||-2.0|-6.4|0.003
72521637|NCT01269047|144572108|OTHER||Mean Difference (Final Values)|-0.66|STANDARD_DEVIATION|2.0||0.37|TWO_SIDED|95.0|-2.3|0.98|||ANOVA|||||0.98|-2.3|0.37
72521638|NCT01269047|144572109|OTHER||Mean Difference (Final Values)|0.3|STANDARD_DEVIATION|0.8||0.2|TWO_SIDED|95.0|-0.21|0.81|||t-test, 2 sided|||||0.81|-0.21|0.2
72521639|NCT01269047|144572109|OTHER||Mean Difference (Final Values)|0.13|STANDARD_DEVIATION|0.6||0.48|TWO_SIDED|95.0|-0.25|0.5|||t-test, 2 sided|||||0.50|-0.25|0.48
72521640|NCT01269047|144572109|OTHER||Mean Difference (Final Values)|0.23|STANDARD_DEVIATION|0.6||0.18|TWO_SIDED|95.0|-0.12|0.57|||t-test, 2 sided|||||0.57|-0.12|0.18
72521641|NCT01269047|144572109|OTHER||Mean Difference (Final Values)|-0.004|STANDARD_DEVIATION|1.0||1|TWO_SIDED|95.0|-0.62|0.61|||t-test, 2 sided|||||0.61|-0.62|1.0
72521642|NCT00418717|144572178|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1||||||95.0|-0.25|0.06||||||||0.06|-0.25|
72521643|NCT00249795|144572180|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.992||||0.857|TWO_SIDED|95.0|0.907|1.085||The cumulative incidence function of this event was calculated for each treatment group using the non-parametric Kaplan-Meier method and the comparison was performed using a 2-sided Log Rank test at 4.5% level to account for multiplicity.|Log Rank|Logrank statistic was stratified on ACTIVE A/W strata.|HR was estimated using a Cox's proportional hazard model stratified on ACTIVE A/W strata with treatment group factor. It provides the relative hazard of any component of the composite event in Irbesartan group versus Placebo group.|||1.085|0.907|0.8570
72521644|NCT00249795|144572181|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.94||||0.12|TWO_SIDED|95.0|0.869|1.016||The cumulative incidence function of this event was calculated for each treatment group using the non-parametric Kaplan-Meier method and the comparison was performed using a 2-sided Log Rank test at 1% level to account for multiplicity.|Log Rank|Logrank statistic was stratified on ACTIVE A/W strata.|HR was estimated using a Cox's proportional hazard model stratified on ACTIVE A/W strata with treatment group factor. It provides the relative hazard of any component of the composite event in Irbesartan group versus Placebo group.|||1.016|0.869|0.1200
72521645|NCT00249795|144572182|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.916||||0.2162|TWO_SIDED|95.0|0.796|1.053||The cumulative incidence function of this event was calculated for each treatment group using the non-parametric Kaplan-Meier method and the comparison was performed using a 2-sided Log Rank test at 5% level.|Log Rank|Logrank statistic was stratified on ACTIVE A/W strata.|HR was estimated using a Cox's proportional hazard model stratified on ACTIVE A/W strata with treatment group factor. It provides the relative hazard of a stroke in Irbesartan group versus Placebo group.|||1.053|0.796|0.2162
72521646|NCT00249795|144572183|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.014||||0.759|TWO_SIDED|95.0|0.927|1.11||The cumulative incidence function of this event was calculated for each treatment group using the non-parametric Kaplan-Meier method and the comparison was performed using a 2-sided Log Rank test at 5% level.|Log Rank|Logrank statistic was stratified on ACTIVE A/W strata.|HR was estimated using a Cox's proportional hazard model stratified on ACTIVE A/W strata with treatment group factor. It provides the relative hazard of death in Irbesartan group versus Placebo group.|||1.110|0.927|0.7590
72521647|NCT00249795|144572184|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.897||||0.0369|TWO_SIDED|95.0|0.809|0.993||The cumulative incidence function of this event was calculated for each treatment group using the non-parametric Kaplan-Meier method and the comparison was performed using a 2-sided Log Rank test at 5% level.|Log Rank|Logrank statistic was stratified on ACTIVE A/W strata.|HR was estimated using a Cox's proportional hazard model stratified on ACTIVE A/W strata with treatment group factor. It provides the relative hazard of HF episodes in Irbesartan group versus Placebo group.|||0.993|0.809|0.0369
72521648|NCT00249795|144572185|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.863||||0.0175|TWO_SIDED|95.0|0.763|0.975||The cumulative incidence function of this event was calculated for each treatment group using the non-parametric Kaplan-Meier method and the comparison was performed using a 2-sided Log Rank test at 5% level.|Log Rank|Logrank statistic was stratified on ACTIVE A/W strata.|HR was estimated using a Cox's proportional hazard model stratified on ACTIVE A/W strata with treatment group factor. It provides the relative hazard of hospitalization for Heart Failure in Irbesartan group versus Placebo group.|||0.975|0.763|0.0175
72570108|NCT02504671|144670135|OTHER||Difference|0.0|||||TWO_SIDED|95.0|-10.3|10.3|||||Week 4, ACR50. Difference to Placebo for Week 4 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||10.3|-10.3|
72570109|NCT02504671|144670135|OTHER||Difference|0.0|||||TWO_SIDED|95.0|-10.3|10.3|||||Week 4, ACR50. Difference to Placebo for Week 4 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||10.3|-10.3|
72570110|NCT02504671|144670135|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-7.0|17.8|||||Week 4, ACR50. Difference to Placebo for Week 4 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||17.8|-7.0|
72570111|NCT02504671|144670135|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||Week 4, ACR70. Difference to Placebo for Week 4 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
72570112|NCT02504671|144670135|OTHER||Difference|10.8|||||TWO_SIDED|95.0|-9.3|30.9|||||Week 6, ACR20. Difference to Placebo for Week 6 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||30.9|-9.3|
72570113|NCT02504671|144670135|OTHER||Difference|8.1|||||TWO_SIDED|95.0|-11.7|27.9|||||Week 6, ACR20. Difference to Placebo for Week 6 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||27.9|-11.7|
72570114|NCT02504671|144670135|OTHER||Difference|10.8|||||TWO_SIDED|95.0|-9.3|30.9|||||Week 6, ACR20. Difference to Placebo for Week 6 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||30.9|-9.3|
72521649|NCT00249795|144572186|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.008||||0.8377|TWO_SIDED|95.0|0.93|1.093||The cumulative incidence function of this event was calculated for each treatment group using the non-parametric Kaplan-Meier method and the comparison was performed using a 2-sided Log Rank test at 5% level.|Log Rank|Logrank statistic was stratified on ACTIVE A/W strata.|HR was estimated using a Cox's proportional hazard model stratified on ACTIVE A/W strata with treatment group factor. It provides the relative hazard of hospitalization for other CV cause in Irbesartan group versus Placebo group.|||1.093|0.930|0.8377
72570115|NCT02504671|144670135|OTHER||Difference|-5.4|||||TWO_SIDED|95.0|-17.8|7.0|||||Week 6, ACR50. Difference to Placebo for Week 6 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.0|-17.8|
72570116|NCT02504671|144670135|OTHER||Difference|-2.7|||||TWO_SIDED|95.0|-16.0|10.6|||||Week 6, ACR50. Difference to Placebo for Week 6 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||10.6|-16.0|
72570117|NCT02504671|144670135|OTHER||Difference|0.0|||||TWO_SIDED|95.0|-14.1|14.1|||||Week 6, ACR50. Difference to Placebo for Week 6 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||14.1|-14.1|
72570118|NCT02504671|144670135|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||Week 6, ACR70. Difference to Placebo for Week 6 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
72570119|NCT02504671|144670135|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||Week 6, ACR70. Difference to Placebo for Week 6 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
72570120|NCT02504671|144670135|OTHER||Difference|8.1|||||TWO_SIDED|95.0|-10.1|26.3|||||Week 8, ACR20. Difference to Placebo for Week 8 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||26.3|-10.1|
72570121|NCT02504671|144670135|OTHER||Difference|24.3|||||TWO_SIDED|95.0|4.5|44.1|||||Week 8, ACR20. Difference to Placebo for Week 8 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||44.1|4.5|
72570122|NCT02504671|144670135|OTHER||Difference|29.7|||||TWO_SIDED|95.0|9.8|49.7|||||Week 8, ACR20. Difference to Placebo for Week 8 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||49.7|9.8|
72570123|NCT02504671|144670135|OTHER||Difference|8.1|||||TWO_SIDED|95.0|-3.2|19.4|||||Week 8, ACR50. Difference to Placebo for Week 8 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||19.4|-3.2|
72570124|NCT02504671|144670135|OTHER||Difference|10.8|||||TWO_SIDED|95.0|-1.4|23.0|||||Week 8, ACR50. Difference to Placebo for Week 8 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||23.0|-1.4|
72369316|NCT00611026|144248569|SUPERIORITY_OR_OTHER|||||||0.0177|TWO_SIDED||||||Cochran-Mantel-Haenszel|P-value was obtained from a Cochran-Mantel-Haenszel test (CMH) with modified ridit scoring and stratified by country.||Treatment difference Tolterodine ER vs Fesoterodine at Week 4.||||0.0177
72369317|NCT00611026|144248569|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|P-value was obtained from a Cochran-Mantel-Haenszel test (CMH) with modified ridit scoring and stratified by country.||Treatment difference fesoterodine vs placebo at Week 12.||||<0.0001
72369318|NCT00611026|144248569|SUPERIORITY_OR_OTHER|||||||0.0107|TWO_SIDED||||||Cochran-Mantel-Haenszel|P-value was obtained from a Cochran-Mantel-Haenszel test (CMH) with modified ridit scoring and stratified by country.||Treatment difference Tolterodine ER vs placebo at Week 12.||||0.0107
72369319|NCT00611026|144248569|SUPERIORITY_OR_OTHER|||||||0.0005|TWO_SIDED||||||Cochran-Mantel-Haenszel|P-value was obtained from a Cochran-Mantel-Haenszel test (CMH) with modified ridit scoring and stratified by country.||Treatment difference Tolterodine ER vs Fesoterodine at Week 12.||||0.0005
72369320|NCT00611026|144248570|SUPERIORITY_OR_OTHER|||||||0.0011|TWO_SIDED||||||Cochran-Mantel-Haenszel|P-value was obtained from a Cochran-Mantel-Haenszel test (CMH) with modified ridit scoring and stratified by country.||Treatment difference fesoterodine vs placebo at Week 1.||||0.0011
72369321|NCT00611026|144248570|SUPERIORITY_OR_OTHER|||||||0.0072|TWO_SIDED||||||Cochran-Mantel-Haenszel|P-value was obtained from a Cochran-Mantel-Haenszel test (CMH) with modified ridit scoring and stratified by country.||Treatment difference Tolterodine ER vs placebo at Week 1.||||0.0072
72369322|NCT00611026|144248570|SUPERIORITY_OR_OTHER|||||||0.3713|TWO_SIDED||||||Cochran-Mantel-Haenszel|P-value was obtained from a Cochran-Mantel-Haenszel test (CMH) with modified ridit scoring and stratified by country.||Treatment difference fesoterodine vs Tolterodine ER at Week 1.||||0.3713
72369323|NCT00611026|144248570|SUPERIORITY_OR_OTHER|||||||0.0002|TWO_SIDED||||||Cochran-Mantel-Haenszel|P-value was obtained from a Cochran-Mantel-Haenszel test (CMH) with modified ridit scoring and stratified by country.||Treatment difference fesoterodine vs placebo at Week 4.||||0.0002
72369324|NCT00611026|144248570|SUPERIORITY_OR_OTHER|||||||0.1485|TWO_SIDED||||||Cochran-Mantel-Haenszel|P-value was obtained from a Cochran-Mantel-Haenszel test (CMH) with modified ridit scoring and stratified by country.||Treatment difference Tolterodine ER vs placebo at Week 4.||||0.1485
72369325|NCT00611026|144248570|SUPERIORITY_OR_OTHER|||||||0.004|TWO_SIDED||||||Cochran-Mantel-Haenszel|P-value was obtained from a Cochran-Mantel-Haenszel test (CMH) with modified ridit scoring and stratified by country.||Treatment difference fesoterodine vs Tolterodine ER at Week 4.||||0.0040
72369326|NCT00611026|144248570|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|P-value was obtained from a Cochran-Mantel-Haenszel test (CMH) with modified ridit scoring and stratified by country.||Treatment difference fesoterodine vs placebo at Week 12.||||<0.0001
72406014|NCT00653224|144320360|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.39|||<|0.001||95.0|-0.61|-0.18||If the p-value of this estimated difference is lower than 5% the mean change from baseline in RQLQ practical problems score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the change from baseline in RQLQ practical pbs. score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean change from baseline in RQLQ practical problems score at endpoint visit is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.18|-0.61|<0.001
72406015|NCT00653224|144320361|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.36|||<|0.001||95.0|-0.57|-0.16||If the p-value of this estimated difference is lower than 5% the mean change from baseline in RQLQ practical problems score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the change from baseline in RQLQ practical pbs. score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean change from baseline in RQLQ practical problems score at visit 3 (week 1) is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.16|-0.57|<0.001
72521650|NCT02460978|144572192|SUPERIORITY||Mean Difference (Final Values)|-0.37|STANDARD_ERROR_OF_MEAN|0.0579|<|0.0001|TWO_SIDED|95.0|-0.49|-0.26|||Mixed Models Analysis|Model is adjusted for baseline HbA1c, treatment, week, randomization stratum, week\*treatment, and week\*baseline HbA1c.||Difference vs. placebo in adjusted mean change from baseline||-0.26|-0.49|<0.0001
72521651|NCT02460978|144572192|SUPERIORITY||Mean Difference (Final Values)|-0.42|STANDARD_ERROR_OF_MEAN|0.0578|<|0.0001|TWO_SIDED|95.0|-0.53|-0.3|||Mixed Models Analysis|Model is adjusted for baseline HbA1c, treatment, week, randomization stratum, week\*treatment, and week\*baseline HbA1c.||Difference vs. placebo in adjusted mean change from baseline||-0.30|-0.53|<0.0001
72521652|NCT02460978|144572193|SUPERIORITY||Mean Difference (Final Values)|-10.78|STANDARD_ERROR_OF_MEAN|1.5291|<|0.0001|TWO_SIDED|95.0|-13.73|-7.72|||Mixed Models Analysis|Adjusted for ln(baseline), treatment, week, randomization stratum, week\*treatment, week\*ln(baseline).||Difference vs. placebo in adjusted mean percentage change from baseline||-7.72|-13.73|<0.0001
72521653|NCT02460978|144572193|SUPERIORITY||Mean Difference (Final Values)|-11.08|STANDARD_ERROR_OF_MEAN|1.5331|<|0.0001|TWO_SIDED|95.0|-14.04|-8.02|||Mixed Models Analysis|Adjusted for ln(baseline), treatment, week, randomization stratum, week\*treatment, and week\*ln(baseline).||Difference vs. placebo in adjusted mean percentage change from baseline||-8.02|-14.04|<0.0001
72521654|NCT02460978|144572194|SUPERIORITY||Mean Difference (Final Values)|-3.21|STANDARD_ERROR_OF_MEAN|0.3829|<|0.0001|TWO_SIDED|95.0|-3.96|-2.45|||Mixed Models Analysis|Adjusted for ln(baseline), treatment, week, randomization stratum, week\*treatment, and week\*ln(baseline).||Difference vs. placebo in adjusted mean percentage change from baseline||-2.45|-3.96|<0.0001
72521655|NCT02460978|144572194|SUPERIORITY||Mean Difference (Final Values)|-3.74|STANDARD_ERROR_OF_MEAN|0.3812|<|0.0001|TWO_SIDED|95.0|-4.49|-2.99|||Mixed Models Analysis|Adjusted for ln(baseline), treatment, week, randomization stratum, week\*treatment, and week\*ln(baseline).||Difference vs. placebo in adjusted mean percentage change from baseline||-2.99|-4.49|<0.0001
72521656|NCT02460978|144572195|SUPERIORITY||Mean Difference (Final Values)|-15.66|STANDARD_ERROR_OF_MEAN|2.3468|<|0.0001|TWO_SIDED|95.0|-20.26|-11.05|||Mixed Models Analysis|Adjusted for baseline, treatment, week, randomization stratum, week\*treatment, and week\*baseline.||Difference vs. placebo in adjusted mean change from baseline||-11.05|-20.26|<0.0001
72521657|NCT02460978|144572195|SUPERIORITY||Mean Difference (Final Values)|-19.74|STANDARD_ERROR_OF_MEAN|2.3419|<|0.0001|TWO_SIDED|95.0|-24.34|-15.14|||Mixed Models Analysis|Adjusted for baseline, treatment, week, randomization stratum, week\*treatment, and week\*baseline.||Difference vs. placebo in adjusted mean change from baseline||-15.14|-24.34|<0.0001
72521658|NCT02460978|144572196|SUPERIORITY||Mean Difference (Final Values)|-9.85|STANDARD_ERROR_OF_MEAN|2.4519|<|0.0001|TWO_SIDED|95.0|-14.66|-5.03|||Mixed Models Analysis|Adjusted for baseline, treatment, week, randomization stratum, week\*treatment, and week\*baseline.||Difference vs. placebo in adjusted mean change from baseline||-5.03|-14.66|<0.0001
72521659|NCT02460978|144572196|SUPERIORITY||Mean Difference (Final Values)|-9.36|STANDARD_ERROR_OF_MEAN|2.4487||0.0001|TWO_SIDED|95.0|-14.16|-4.55|||Mixed Models Analysis|Adjusted for baseline, treatment, week, randomization stratum, week\*treatment, and week\*baseline.||Difference vs. placebo in adjusted mean change from baseline||-4.55|-14.16|0.0001
72521660|NCT02460978|144572197|SUPERIORITY||Mean Difference (Final Values)|9.02|STANDARD_ERROR_OF_MEAN|1.0415|<|0.0001|TWO_SIDED|95.0|6.97|11.06|||Mixed Models Analysis|Adjusted for baseline, treatment, week, randomization stratum, week\*treatment, and week\*baseline.||Difference vs. placebo in adjusted mean change from baseline||11.06|6.97|<0.0001
72625016|NCT02989857|144779567|OTHER||Least-squares mean difference|11.0|||||TWO_SIDED|95.0|4.23|17.73||||||Cycle 2 Day 1: Physical Functioning||17.73|4.23|
72625017|NCT02989857|144779567|OTHER||Least-squares mean difference|-10.4|||||TWO_SIDED|95.0|-20.18|-0.52||||||Cycle 2 Day 1: Pain||-0.52|-20.18|
72521661|NCT02460978|144572197|SUPERIORITY||Mean Difference (Final Values)|10.7|STANDARD_ERROR_OF_MEAN|1.0396|<|0.0001|TWO_SIDED|95.0|8.66|12.74|||Mixed Models Analysis|Adjusted for baseline, treatment, week, randomization stratum, week\*treatment, and week\*baseline.||Difference vs. placebo in adjusted mean change from baseline||12.74|8.66|<0.0001
72521662|NCT02460978|144572198|SUPERIORITY||Odds Ratio (OR)|2.71|STANDARD_ERROR_OF_MEAN|0.2058|<|0.0001|TWO_SIDED|95.0|1.81|4.06|||Regression, Logistic|Adjusted for baseline HbA1c and randomization strata||Odds Ratio vs. Placebo||4.06|1.81|<0.0001
72521663|NCT02460978|144572198|SUPERIORITY||Odds Ratio (OR)|3.07|STANDARD_ERROR_OF_MEAN|0.2054|<|0.0001|TWO_SIDED|95.0|2.05|4.6|||Regression, Logistic|Adjusted for baseline HbA1c and randomization strata||Odds Ratio vs. Placebo||4.60|2.05|<0.0001
72521664|NCT03549429|144572205|SUPERIORITY||Percent difference|8.0||||0.03|TWO_SIDED|95.0|1.5|14.4|||McNemar|||We compared the proportion of patients who had postoperative eyelid erythema with Tegaderm™ to those who had postop eyelid erythema with EyeGard®.||14.4|1.5|0.03
72521665|NCT03549429|144572206|SUPERIORITY||Mean Difference (Final Values)|0.03||||0.23|TWO_SIDED||||||t-test, 2 sided|paired||||||0.23
72625018|NCT02989857|144779567|OTHER||Least-squares mean difference|3.6|||||TWO_SIDED|95.0|-6.65|13.91||||||Cycle 2 Day 1: Appetite Loss||13.91|-6.65|
72625019|NCT02989857|144779567|OTHER||Least-squares mean difference|12.3|||||TWO_SIDED|95.0|3.85|20.78||||||Cycle 3 Day 1: Physical Functioning||20.78|3.85|
72406016|NCT00653224|144320362|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|||<|0.001||95.0|-0.61|-0.18||If the p-value of this estimated difference is lower than 5% the mean change from baseline in RQLQ practical problems score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the change from baseline in RQLQ practical pbs. score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean change from baseline in RQLQ practical problems score at visit 4 (week 2) is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.18|-0.61|<0.001
72521666|NCT01962688|144572213|OTHER|||||||0.002|||||||Chi-squared|||||||0.002
72521667|NCT00669032|144572217|SUPERIORITY_OR_OTHER_LEGACY|||||||0.004|ONE_SIDED||||||Chi-squared|||||||0.004
72521668|NCT00669032|144572218|SUPERIORITY_OR_OTHER_LEGACY|||||||0.525|TWO_SIDED||||||Chi-squared|||||||0.525
72521669|NCT00669032|144572219|SUPERIORITY_OR_OTHER_LEGACY|||||||0.03|TWO_SIDED||||||Chi-squared|||||||0.030
72521670|NCT00669032|144572220|SUPERIORITY_OR_OTHER_LEGACY|||||||0.049|TWO_SIDED||||||Chi-squared|||||||0.049
72521671|NCT00669032|144572221|SUPERIORITY_OR_OTHER_LEGACY|||||||0.049|TWO_SIDED||||||Chi-squared|||||||0.049
72521672|NCT00669032|144572222|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002|TWO_SIDED||||||Chi-squared|||||||0.002
72521673|NCT00669032|144572223|SUPERIORITY_OR_OTHER_LEGACY|||||||0.021|TWO_SIDED||||||Chi-squared|||||||0.021
72521674|NCT00669032|144572224|SUPERIORITY_OR_OTHER_LEGACY|||||||0.025|TWO_SIDED||||||Chi-squared|||||||0.025
72521675|NCT00669032|144572225|SUPERIORITY_OR_OTHER_LEGACY|||||||0.023|TWO_SIDED||||||Chi-squared|||||||0.023
72521676|NCT00669032|144572226|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002|TWO_SIDED||||||Chi-squared|||||||0.002
72570125|NCT02504671|144670135|OTHER||Difference|16.2|||||TWO_SIDED|95.0|2.6|29.9|||||Week 8, ACR50. Difference to Placebo for Week 8 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||29.9|2.6|
72406017|NCT00653224|144320363|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.38|||<|0.001||95.0|-0.59|-0.18||If the p-value of this estimated difference is lower than 5% the mean change from baseline in RQLQ nasal symptoms score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the change from baseline in RQLQ nasal symptoms score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean change from baseline in RQLQ nasal symptoms score at endpoint visit is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.18|-0.59|<0.001
72521677|NCT00669032|144572227|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9129|TWO_SIDED||||||Chi-squared|||||||0.9129
72570126|NCT02504671|144670135|OTHER||Difference|-2.7|||||TWO_SIDED|95.0|-7.9|2.5|||||Week 8, ACR70. Difference to Placebo for Week 8 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||2.5|-7.9|
72570127|NCT02504671|144670135|OTHER||Difference|0.0|||||TWO_SIDED|95.0|-7.4|7.4|||||Week 8, ACR70. Difference to Placebo for Week 8 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.4|-7.4|
72521678|NCT03627494|144572283|OTHER||Ratio|0.93|||||TWO_SIDED|90.0|0.84|1.03|||||"Analysis was performed using Mixed Effect Model with treatment and period as fixed effect and participant as random effect. Variance Components covariance structure was used."|||1.03|0.84|
72521679|NCT03627494|144572284|OTHER||Ratio|0.93|||||TWO_SIDED|90.0|0.84|1.04|||||"Analysis was performed using Mixed Effect Model with treatment and period as fixed effect and participant as random effect. Variance Components covariance structure was used."|||1.04|0.84|
72521680|NCT03627494|144572285|OTHER||Ratio|0.89|||||TWO_SIDED|90.0|0.79|1.01|||||"Analysis was performed using Mixed Effect Model with treatment and period as fixed effect and participant as random effect. Variance Components covariance structure was used."|||1.01|0.79|
72521681|NCT00878644|144572303|SUPERIORITY||Risk Difference (RD)|7.3||||0.14|TWO_SIDED|95.0|-1.5|16.1|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test was used adjusting for age category at time of randomization (\<2 years, 2 to \<12 years, or \>=12 years)||||16.1|-1.5|0.14
72521682|NCT00878644|144572304|SUPERIORITY||Risk Difference (RD)|9.1||||0.13|TWO_SIDED|95.0|-1.8|19.9|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test was used adjusting for age category at time of randomization (\<2 years, 2 to \<12 years, or \>=12 years)||||19.9|-1.8|0.13
72521683|NCT00878644|144572305|SUPERIORITY|||||||0.13|||||||Stratified Mann-Whitney Test|Test stratified by age category (\<2 years, 2 to \<12 years, or \>=12 years), for continuous (NOT categorized as reported above) 1-year change in VABS-II|||As the (nonparametric) comparison treated 1-year deaths as worst possible outcomes and worst possible 1-year VABS-II as next worst possible outcomes, using change in VABS-II for other participants alive at 1 year, no relevant estimation of effect size is possible for this secondary outcome.|||0.13
72521684|NCT00878644|144572306|SUPERIORITY|||||||0.81|||||||Wilcoxon (Mann-Whitney)|"Test used the continuous (NOT categorized as reported above) neuropsychological scores, with Lowest Possible Score treated as lowest possible value."||||||0.81
72521685|NCT02371980|144572312|SUPERIORITY||Hazard Ratio (HR)|0.517||||0.006|TWO_SIDED|95.0|0.323|0.828||Gate-keeping fixed-sequence testing procedure was used for multiple comparisons.|Cox Proportional Hazards Model|Cox proportional hazards model with a factor for treatment and baseline II MADRS total score as a covariate, using the exact method to handle ties.||Double-blind Vortioxetine 5mg Vs Double-blind Placebo||0.828|0.323|0.006
72521686|NCT02371980|144572312|SUPERIORITY||Hazard Ratio (HR)|0.476||||0.002|TWO_SIDED|95.0|0.296|0.767||Gate-keeping fixed-sequence testing procedure was used for multiple comparisons.|Cox Proportional Hazards Model|Cox proportional hazards model with a factor for treatment and baseline II MADRS total score as a covariate, using the exact method to handle ties.||Double-blind Vortioxetine 10 mg Vs Double-blind Placebo||0.767|0.296|0.002
72521687|NCT02371980|144572312|SUPERIORITY||Hazard Ratio (HR)|0.483||||0.003|TWO_SIDED|95.0|0.298|0.782||Gate-keeping fixed-sequence testing procedure was used for multiple comparisons.|Cox Proportional Hazards Model|Cox proportional hazards model with a factor for treatment and baseline II MADRS total score as a covariate, using the exact method to handle ties.||Double-blind Vortioxetine 20 mg Vs Double-blind Placebo||0.782|0.298|0.003
72521688|NCT02371980|144572313|SUPERIORITY||Least Squares Mean (LSM) Difference|-0.48|STANDARD_ERROR_OF_MEAN|0.59||0.421|TWO_SIDED|95.0|-1.63|0.68|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 2||0.68|-1.63|0.421
72406018|NCT00653224|144320364|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.35|||<|0.001||95.0|-0.55|-0.16||If the p-value of this estimated difference is lower than 5% the mean change from baseline in RQLQ nasal symptoms score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the change from baseline in RQLQ nasal symptoms score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean change from baseline in RQLQ nasal symptoms score at visit 3 (week 1) is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.16|-0.55|<0.001
72406019|NCT00653224|144320365|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.38|||<|0.001||95.0|-0.59|-0.17||If the p-value of this estimated difference is lower than 5% the mean change from baseline in RQLQ nasal symptoms score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the change from baseline in RQLQ nasal symptoms score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean change from baseline in RQLQ nasal symptoms score at visit 4 (week 2) is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.17|-0.59|<0.001
72406020|NCT00653224|144320366|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.42|||<|0.001||95.0|-0.63|-0.21||If the p-value of this estimated difference is lower than 5% the mean change from baseline in RQLQ eye symptoms score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the change from baseline in RQLQ eye symptoms score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean change from baseline in RQLQ eye symptoms score at endpoint visit is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.21|-0.63|<0.001
72406021|NCT00653224|144320367|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.37|||<|0.001||95.0|-0.56|-0.17||If the p-value of this estimated difference is lower than 5% the mean change from baseline in RQLQ eye symptoms score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the change from baseline in RQLQ eye symptoms score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean change from baseline in RQLQ eye symptoms score at visit 3 (week 1) is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.17|-0.56|<0.001
72406022|NCT00653224|144320368|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.42|||<|0.001||95.0|-0.63|-0.22||If the p-value of this estimated difference is lower than 5% the mean change from baseline in RQLQ eye symptoms score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the change from baseline in RQLQ eye symptoms score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean change from baseline in RQLQ eye symptoms score at visit 4 (week 2) is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.22|-0.63|<0.001
72406023|NCT00653224|144320369|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.33|||<|0.001||95.0|-0.53|-0.13||If the p-value of this estimated difference is lower than 5% the mean change from baseline in RQLQ emotional score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the change from baseline in RQLQ emotional score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean change from baseline in RQLQ emotional score at endpoint visit is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.13|-0.53|<0.001
72521689|NCT02371980|144572313|SUPERIORITY||Least Squares Mean Difference|-1.23|STANDARD_ERROR_OF_MEAN|0.589||0.037|TWO_SIDED|95.0|-2.39|-0.08|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 2||-0.08|-2.39|0.037
72521690|NCT02371980|144572313|SUPERIORITY||Least Squares Mean Difference|-0.41|STANDARD_ERROR_OF_MEAN|0.592||0.488|TWO_SIDED|95.0|-1.57|0.75|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 2||0.75|-1.57|0.488
72521691|NCT02371980|144572313|SUPERIORITY||Least Squares Mean Difference|-2.43|STANDARD_ERROR_OF_MEAN|0.765||0.002|TWO_SIDED|95.0|-3.93|-0.93|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 4||-0.93|-3.93|0.002
72521692|NCT02371980|144572313|SUPERIORITY||Least Squares Mean Difference|-3.0|STANDARD_ERROR_OF_MEAN|0.761|<|0.001|TWO_SIDED|95.0|-4.49|-1.51|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 4||-1.51|-4.49|<0.001
72521693|NCT02371980|144572313|SUPERIORITY||Least Squares Mean Difference|-2.5|STANDARD_ERROR_OF_MEAN|0.775||0.001|TWO_SIDED|95.0|-4.02|-0.98|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 4||-0.98|-4.02|0.001
72521694|NCT02371980|144572313|SUPERIORITY||Least Squares Mean Difference|-2.95|STANDARD_ERROR_OF_MEAN|0.924||0.001|TWO_SIDED|95.0|-4.76|-1.13|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 8||-1.13|-4.76|0.001
72521695|NCT02371980|144572313|SUPERIORITY||Least Squares Mean Difference|-3.84|STANDARD_ERROR_OF_MEAN|0.919|<|0.001|TWO_SIDED|95.0|-5.64|-2.03|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 8||-2.03|-5.64|<0.001
72521696|NCT02371980|144572313|SUPERIORITY||Least Squares Mean Difference|-3.0|STANDARD_ERROR_OF_MEAN|0.939||0.001|TWO_SIDED|95.0|-4.84|-1.16|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 8||-1.16|-4.84|0.001
72570128|NCT02504671|144670135|OTHER||Difference|8.1|||||TWO_SIDED|95.0|-3.2|19.4|||||Week 8, ACR70. Difference to Placebo for Week 8 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||19.4|-3.2|
72521697|NCT02371980|144572313|SUPERIORITY||Least Squares Mean Difference|-2.92|STANDARD_ERROR_OF_MEAN|0.938||0.002|TWO_SIDED|95.0|-4.76|-1.08|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 12||-1.08|-4.76|0.002
72521698|NCT02371980|144572313|SUPERIORITY||Least Squares Mean Difference|-4.51|STANDARD_ERROR_OF_MEAN|0.934|<|0.001|TWO_SIDED|95.0|-6.34|-2.68|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 12||-2.68|-6.34|<0.001
72406024|NCT00653224|144320370|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.34|||<|0.001||95.0|-0.52|-0.15||If the p-value of this estimated difference is lower than 5% the mean change from baseline in RQLQ emotional score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the change from baseline in RQLQ emotional score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean change from baseline in RQLQ emotional score at visit 3 (week 1) is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.15|-0.52|<0.001
72521699|NCT02371980|144572313|SUPERIORITY||Least Squares Mean Difference|-3.64|STANDARD_ERROR_OF_MEAN|0.949|<|0.001|TWO_SIDED|95.0|-5.5|-1.78|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 12||-1.78|-5.50|<0.001
72521700|NCT02371980|144572313|SUPERIORITY||Least Squares Mean Difference|-2.04|STANDARD_ERROR_OF_MEAN|0.957||0.033|TWO_SIDED|95.0|-3.92|-0.16|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 16||-0.16|-3.92|0.033
72521701|NCT02371980|144572313|SUPERIORITY||Least Squares Mean Difference|-3.69|STANDARD_ERROR_OF_MEAN|0.952|<|0.001|TWO_SIDED|95.0|-5.55|-1.82|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 16||-1.82|-5.55|<0.001
72521702|NCT02371980|144572313|SUPERIORITY||Least Squares Mean Difference|-2.63|STANDARD_ERROR_OF_MEAN|0.967||0.007|TWO_SIDED|95.0|-4.52|-0.73|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 16||-0.73|-4.52|0.007
72521703|NCT02371980|144572313|SUPERIORITY||Least Squares Mean Difference|-2.61|STANDARD_ERROR_OF_MEAN|0.912||0.004|TWO_SIDED|95.0|-4.4|-0.82|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 20||-0.82|-4.40|0.004
72521704|NCT02371980|144572313|SUPERIORITY||Least Squares Mean Difference|-4.09|STANDARD_ERROR_OF_MEAN|0.906|<|0.001|TWO_SIDED|95.0|-5.86|-2.31|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 20||-2.31|-5.86|<0.001
72521705|NCT02371980|144572313|SUPERIORITY||Least Squares Mean Difference|-2.76|STANDARD_ERROR_OF_MEAN|0.921||0.003|TWO_SIDED|95.0|-4.57|-0.96|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 20||-0.96|-4.57|0.003
72521706|NCT02371980|144572313|SUPERIORITY||Least Squares Mean Difference|-1.92|STANDARD_ERROR_OF_MEAN|1.008||0.057|TWO_SIDED|95.0|-3.89|0.06|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 24||0.06|-3.89|0.057
72521707|NCT02371980|144572313|SUPERIORITY||Least Squares Mean Difference|-3.5|STANDARD_ERROR_OF_MEAN|0.997|<|0.001|TWO_SIDED|95.0|-5.46|-1.55|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 24||-1.55|-5.46|<0.001
72521708|NCT02371980|144572313|SUPERIORITY||Least Squares Mean Difference|-2.53|STANDARD_ERROR_OF_MEAN|1.011||0.012|TWO_SIDED|95.0|-4.51|-0.55|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 24||-0.55|-4.51|0.012
72521709|NCT02371980|144572313|SUPERIORITY||Least Squares Mean Difference|-1.9|STANDARD_ERROR_OF_MEAN|1.012||0.061|TWO_SIDED|95.0|-3.88|0.09|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 28||0.09|-3.88|0.061
72521710|NCT02371980|144572313|SUPERIORITY||Least Squares Mean Difference|-2.36|STANDARD_ERROR_OF_MEAN|0.997||0.018|TWO_SIDED|95.0|-4.31|-0.4|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 28||-0.40|-4.31|0.018
72521711|NCT02371980|144572313|SUPERIORITY||Least Squares Mean Difference|-1.88|STANDARD_ERROR_OF_MEAN|1.015||0.065|TWO_SIDED|95.0|-3.87|0.12|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 28||0.12|-3.87|0.065
72521712|NCT02371980|144572313|SUPERIORITY||MMRM Model|-3.09|STANDARD_ERROR_OF_MEAN|1.136||0.007|TWO_SIDED|95.0|-5.31|-0.86|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 32||-0.86|-5.31|0.007
72521713|NCT02371980|144572313|SUPERIORITY||Least Squares Mean Difference|-3.97|STANDARD_ERROR_OF_MEAN|1.122|<|0.001|TWO_SIDED|95.0|-6.16|-1.77|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 32||-1.77|-6.16|<0.001
72521714|NCT02371980|144572313|SUPERIORITY||Least Squares Mean Difference|-3.58|STANDARD_ERROR_OF_MEAN|1.143||0.002|TWO_SIDED|95.0|-5.82|-1.34|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 32||-1.34|-5.82|0.002
72570129|NCT02504671|144670135|OTHER||Difference|24.3|||||TWO_SIDED|95.0|6.0|42.7|||||Week 12, ACR20. Difference to Placebo for Week 12 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||42.7|6.0|
72521715|NCT02371980|144572314|SUPERIORITY||Least Squares Mean Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.085||0.732|TWO_SIDED|95.0|-0.2|0.14|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 2||0.14|-0.20|0.732
72625020|NCT02989857|144779567|OTHER||Least-squares mean difference|4.1|||||TWO_SIDED|95.0|-8.74|17.04||||||Cycle 3 Day 1: Pain||17.04|-8.74|
72625021|NCT02989857|144779567|OTHER||Least-squares mean difference|-3.7|||||TWO_SIDED|95.0|-17.46|10.11||||||Cycle 3 Day 1: Appetite Loss||10.11|-17.46|
72625022|NCT02989857|144779568|OTHER||Least-squares mean difference|-5.1|||||TWO_SIDED|95.0|-12.93|2.8||||||Cycle 2 Day 1: Pain||2.80|-12.93|
72625023|NCT02989857|144779568|OTHER||Least-squares mean difference|0.7|||||TWO_SIDED|95.0|-6.56|7.88||||||Cycle 2 Day 1: Appetite Loss||7.88|-6.56|
72625024|NCT02989857|144779568|OTHER||Least-squares mean difference|4.4|||||TWO_SIDED|95.0|-5.82|14.55||||||Cycle 3 Day 1: Pain||14.55|-5.82|
72521716|NCT02371980|144572314|SUPERIORITY||Least Squares Mean Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.085||0.273|TWO_SIDED|95.0|-0.26|0.07|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 2||0.07|-0.26|0.273
72521717|NCT02371980|144572314|SUPERIORITY||Least Squares Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.085||0.361|TWO_SIDED|95.0|-0.24|0.09|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 2||0.09|-0.24|0.361
72521718|NCT02371980|144572314|SUPERIORITY||Least Squares Mean Difference|-0.28|STANDARD_ERROR_OF_MEAN|0.099||0.004|TWO_SIDED|95.0|-0.48|-0.09|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 4||-0.09|-0.48|0.004
72521719|NCT02371980|144572314|SUPERIORITY||Least Squares Mean Difference|-0.31|STANDARD_ERROR_OF_MEAN|0.099||0.002|TWO_SIDED|95.0|-0.5|-0.12|||Least Squares Mean Difference|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 4||-0.12|-0.50|0.002
72521720|NCT02371980|144572314|SUPERIORITY||Least Squares Mean Difference|-0.36|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.55|-0.16|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 4||-0.16|-0.55|<0.001
72521721|NCT02371980|144572314|SUPERIORITY||Least Squares Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.121||0.014|TWO_SIDED|95.0|-0.54|-0.06|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 8||-0.06|-0.54|0.014
72521722|NCT02371980|144572314|SUPERIORITY||Least Squares Mean Difference|-0.39|STANDARD_ERROR_OF_MEAN|0.121||0.001|TWO_SIDED|95.0|-0.63|-0.16|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 8||-0.16|-0.63|0.001
72521723|NCT02371980|144572314|SUPERIORITY||Least Squares Mean Difference|-0.38|STANDARD_ERROR_OF_MEAN|0.123||0.002|TWO_SIDED|95.0|-0.62|-0.14|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 8||-0.14|-0.62|0.002
72521724|NCT02371980|144572314|SUPERIORITY||Least Squares Mean Difference|-0.27|STANDARD_ERROR_OF_MEAN|0.122||0.025|TWO_SIDED|95.0|-0.51|-0.03|||Least Squares Mean Difference|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 12||-0.03|-0.51|0.025
72521725|NCT02371980|144572314|SUPERIORITY||Least Squares Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.122|<|0.001|TWO_SIDED|95.0|-0.74|-0.26|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 12||-0.26|-0.74|<0.001
72521726|NCT02371980|144572314|SUPERIORITY||Least Squares Mean Difference|-0.39|STANDARD_ERROR_OF_MEAN|0.124||0.002|TWO_SIDED|95.0|-0.63|-0.15|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 12||-0.15|-0.63|0.002
72521727|NCT02371980|144572314|SUPERIORITY||Least Squares Mean Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.123||0.333|TWO_SIDED|95.0|-0.36|0.12|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 16||0.12|-0.36|0.333
72625025|NCT02989857|144779568|OTHER||Least-squares mean difference|-6.1|||||TWO_SIDED|95.0|-15.34|3.12||||||Cycle 3 Day 1: Appetite Loss||3.12|-15.34|
72628216|NCT00492557|144784517|NON_INFERIORITY_OR_EQUIVALENCE|The criterion upon which to declare non-inferiority was if the lower limit of the 2-sided 95%CI for the GMT ratios, (13vPnC+TIV relative to 13vPnC administered 1 month after TIV+placebo) was greater than 0.5 (2-fold criterion).|GMT Ratio|0.9|||||TWO_SIDED|95.0|0.69|1.2|||||2-sided 95% CIs for the GMT ratio were calculated by back transformations of the 95% CIs based on the Student t distribution for the mean difference of the logarithmically transformed assay results.|Serotype 3. The primary null hypothesis was: the log of the GMT in the group receiving 13vPnC + TIV minus the log of the GMT in the group receiving 13vPnC alone (1 month after TIV) \<= -0.693.||1.20|0.69|
72521728|NCT02371980|144572314|SUPERIORITY||Least Squares Mean Difference|-0.37|STANDARD_ERROR_OF_MEAN|0.122||0.002|TWO_SIDED|95.0|-0.61|-0.13|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 16||-0.13|-0.61|0.002
72521729|NCT02371980|144572314|SUPERIORITY||Least Squares Mean Difference|-0.28|STANDARD_ERROR_OF_MEAN|0.124||0.023|TWO_SIDED|95.0|-0.53|-0.04|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 16||-0.04|-0.53|0.023
72521730|NCT02371980|144572314|SUPERIORITY||Least Squares Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.121||0.092|TWO_SIDED|95.0|-0.44|0.03|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 20||0.03|-0.44|0.092
72521731|NCT02371980|144572314|SUPERIORITY||Least Squares Mean Difference|-0.44|STANDARD_ERROR_OF_MEAN|0.121|<|0.001|TWO_SIDED|95.0|-0.67|-0.2|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 20||-0.20|-0.67|<0.001
72521732|NCT02371980|144572314|SUPERIORITY||Least Squares Mean Difference|-0.33|STANDARD_ERROR_OF_MEAN|0.122||0.008|TWO_SIDED|95.0|-0.57|-0.09|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 20||-0.09|-0.57|0.008
72521733|NCT02371980|144572314|SUPERIORITY||Least Squares Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.135||0.248|TWO_SIDED|95.0|-0.42|0.11|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 24||0.11|-0.42|0.248
72521734|NCT02371980|144572314|SUPERIORITY||Least Squares Mean Difference|-0.37|STANDARD_ERROR_OF_MEAN|0.133||0.006|TWO_SIDED|95.0|-0.63|-0.1|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 24||-0.10|-0.63|0.006
72521735|NCT02371980|144572314|SUPERIORITY||Least Squares Mean Difference|-0.23|STANDARD_ERROR_OF_MEAN|0.135||0.087|TWO_SIDED|95.0|-0.5|0.03|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 24||0.03|-0.50|0.087
72521736|NCT02371980|144572314|SUPERIORITY||Least Squares Mean Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.131||0.362|TWO_SIDED|95.0|-0.38|0.14|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 28||0.14|-0.38|0.362
72521737|NCT02371980|144572314|SUPERIORITY||Least Squares Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.129||0.251|TWO_SIDED|95.0|-0.4|0.1|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 28||0.10|-0.40|0.251
72570130|NCT02504671|144670135|OTHER||Difference|29.7|||||TWO_SIDED|95.0|11.0|48.4|||||Week 12, ACR20. Difference to Placebo for Week 12 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||48.4|11.0|
72570131|NCT02504671|144670135|OTHER||Difference|40.5|||||TWO_SIDED|95.0|21.6|59.5|||||Week 12, ACR20. Difference to Placebo for Week 12 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||59.5|21.6|
72570132|NCT02504671|144670135|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-10.6|16.0|||||Week 12, ACR50. Difference to Placebo for Week 12 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||16.0|-10.6|
72521738|NCT02371980|144572314|SUPERIORITY||Least Squares Mean Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.131||0.391|TWO_SIDED|95.0|-0.37|0.14|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 28||0.14|-0.37|0.391
72521739|NCT02371980|144572314|SUPERIORITY||Least Squares Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.141||0.209|TWO_SIDED|95.0|-0.45|0.1|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 32||0.10|-0.45|0.209
72521740|NCT02371980|144572314|SUPERIORITY||Least Squares Mean Difference|-0.33|STANDARD_ERROR_OF_MEAN|0.139||0.018|TWO_SIDED|95.0|-0.6|-0.06|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 32||-0.06|-0.60|0.018
72521741|NCT02371980|144572314|SUPERIORITY||Least Squares Mean Difference|-0.37|STANDARD_ERROR_OF_MEAN|0.141||0.009|TWO_SIDED|95.0|-0.65|-0.09|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 32||-0.09|-0.65|0.009
72521742|NCT02371980|144572316|SUPERIORITY||Hazard Ratio (HR)|0.481||||0.002|TWO_SIDED|95.0|0.302|0.766||Gate-keeping fixed-sequence testing procedure was used for multiple comparisons.|Cox Proportional Hazards Model|Cox proportional hazards model with a factor for treatment and baseline II MADRS total score as a covariate, using the exact method to handle ties.||Double-blind Vortioxetine 5mg Vs Double-blind Placebo||0.766|0.302|0.002
72570133|NCT02504671|144670135|OTHER||Difference|18.9|||||TWO_SIDED|95.0|2.1|35.7|||||Week 12, ACR50. Difference to Placebo for Week 12 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||35.7|2.1|
72570134|NCT02504671|144670135|OTHER||Difference|16.2|||||TWO_SIDED|95.0|-0.2|32.6|||||Week 12, ACR50. Difference to Placebo for Week 12 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||32.6|-0.2|
72570135|NCT02504671|144670135|OTHER||Difference|-2.7|||||TWO_SIDED|95.0|-11.7|6.3|||||Week 12, ACR70. Difference to Placebo for Week 12 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||6.3|-11.7|
72406025|NCT00653224|144320371|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.34|||<|0.001||95.0|-0.53|-0.14||If the p-value of this estimated difference is lower than 5% the mean change from baseline in RQLQ emotional score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the change from baseline in RQLQ emotional score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean change from baseline in RQLQ emotional score at visit 4 (week 2) is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.14|-0.53|<0.001
72521743|NCT02371980|144572316|SUPERIORITY||Hazard Ratio (HR)|0.455|||<|0.001|TWO_SIDED|95.0|0.286|0.725||Gate-keeping fixed-sequence testing procedure was used for multiple comparisons.|Cox Proportional Hazards Model|Cox proportional hazards model with a factor for treatment and baseline II MADRS total score as a covariate, using the exact method to handle ties.||Double-blind Vortioxetine 10 mg Vs Double-blind Placebo||0.725|0.286|<0.001
72521744|NCT02371980|144572316|SUPERIORITY||Hazard Ratio (HR)|0.484||||0.002|TWO_SIDED|95.0|0.304|0.771||Gate-keeping fixed-sequence testing procedure was used for multiple comparisons.|Cox Proportional Hazards Model|Cox proportional hazards model with a factor for treatment and baseline II MADRS total score as a covariate, using the exact method to handle ties.||Double-blind Vortioxetine 20 mg Vs Double-blind Placebo||0.771|0.304|0.002
72521745|NCT05302804|144572326|SUPERIORITY|||||||0.742||||||p-value reflects main effect of treatment.|ANOVA|||"Null hypothesis was there was no difference between menthol gel and control gel~time x trial ANOVA statistical analysis"||||0.742
72406026|NCT00653224|144320372|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.89|||<|0.001||95.0|-1.32|-0.45||If the p-value of this estimated difference is lower than 5% the mean T5SS is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the mean of T5SS including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean T5SS over week 1 is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.45|-1.32|<0.001
72406027|NCT00653224|144320373|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.88|||<|0.001||95.0|-1.39|-0.36||If the p-value of this estimated difference is lower than 5% the mean T5SS is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the mean of T5SS including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean T5SS over week 2 is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.36|-1.39|<0.001
72406028|NCT00653224|144320374|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.84|||<|0.001||95.0|-1.2|-0.49||If the p-value of this estimated difference is lower than 5% the mean T4SS is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the Mean T4SS including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean T4SS over Week 1 is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.49|-1.20|<0.001
72521746|NCT05302804|144572327|SUPERIORITY|||||||0.742||||||p-value is main effect of menthol|ANOVA|||The null hypothesis is that there is no difference between menthol and control trials||||0.742
72521747|NCT05302804|144572328|SUPERIORITY|||||||0.048||||||p-value reflects main effect of menthol|ANOVA|||The null hypothesis is that there is no difference between menthol and control trials||||0.048
72521748|NCT05302804|144572329|SUPERIORITY|||||||0.104|||||||t-test, 2 sided|||The null hypothesis is that there is no difference between menthol and control trials||||.104
72521749|NCT05302804|144572330|SUPERIORITY|||||||0.051|||||||t-test, 2 sided|||The null hypothesis is that there is no difference between menthol and control trials||||.051
72521750|NCT05302804|144572331|SUPERIORITY||||||<|0.001||||||Main effect of treatment|ANOVA|||The null hypothesis is that there is no difference between menthol and control trials||||< 0.001
72521751|NCT05302804|144572332|SUPERIORITY|||||||0.026|||||||ANOVA|||The null hypothesis is that there is no difference between menthol and control trials||||.026
72521752|NCT05302804|144572333|SUPERIORITY|||||||0.001||||||p-value at time 30 min of exercise|ANOVA|||The null hypothesis is that there is no difference between menthol and control trials||||.001
72521753|NCT05302804|144572334|SUPERIORITY||||||>|0.05|||||||t-test, 2 sided|||||||>0.05
72521754|NCT03250624|144572430|SUPERIORITY||Least Square (LS) Mean Difference|-0.28||||0.632|TWO_SIDED|95.0|-1.46|0.89|||ANCOVA|||||0.89|-1.46|0.632
72521755|NCT00948428|144572478|EQUIVALENCE|If the 90% confidence interval around the difference between the Generic Imiquimod and Aldara Complete Clearance rates in the PP population were contained within the interval -0.20 to +0.20, and each of these rates was greater than, and statistically different (p\<0.05) from, the Vehicle rate in the ITT population, then Generic Imiquimod and Aldara were considered to be therapeutically equivalent|Mean Difference (Net)|-0.85|||||TWO_SIDED|90.0|-10.84|9.15||||||||9.15|-10.84|
72521756|NCT00948428|144572478|SUPERIORITY|||||||0.0001|||||||ANOVA|||Based on Intent-to-Treat Population||||0.0001
72521757|NCT00948428|144572479|EQUIVALENCE|If the 90% confidence interval around the difference between the Generic Imiquimod and Aldara Partial Clearance rates in the PP population were contained within the interval -0.20 to +0.20, then Generic Imiquimod and Aldara were considered to be therapeutically equivalent.|Mean Difference (Net)|-3.1|||||TWO_SIDED|90.0|-12.11|5.95||||||||5.95|-12.11|
72521758|NCT00948428|144572480|EQUIVALENCE|If the 90% confidence interval around the difference between the Generic Imiquimod and Aldara Complete Clearance rates in the ITT population were contained within the interval -0.20 to +0.20, then Generic Imiquimod and Aldara were considered to be therapeutically equivalent.|Mean Difference (Net)|-0.5|||||TWO_SIDED|90.0|-9.92|8.88||||||||8.88|-9.92|
72521759|NCT02408484|144572493|OTHER|||||||0.0028||||||p-value for the change in MCF from baseline to 1 hour post infusion for the firstBLEED population|ANOVA|||||||0.0028
72521760|NCT02408484|144572493|OTHER|||||||0.0002||||||p-value for the change in MCF from baseline to 1 hour post infusion for the BLEED population|ANOVA|||||||0.0002
72521761|NCT02864706|144572616|SUPERIORITY|||||||0.0043|||||||ANCOVA|Incidence of CAV at 5-7 yrs was compared between groups using Cochran-Mantel-Haenszel test with stratification according to baseline distribution||||||0.0043
72521762|NCT02864706|144572617|SUPERIORITY|||||||0.037|||||||Cochran-Mantel-Haenszel|||||||0.037
72521763|NCT01599806|144572661|NON_INFERIORITY_OR_EQUIVALENCE|-12.5%|Difference of symp resolution rates|4.0|||||TWO_SIDED|95.0|-2.39|10.42|||Unstratified Miettinen & Nurminen method|||H0: Difference (CAZ-AVI treatment group minus Doripenem treatment group) of symptomatic resolution rates ≤ non-inferiority margin||10.42|-2.39|
72521764|NCT01599806|144572662|NON_INFERIORITY_OR_EQUIVALENCE|-12.5%|Diff of favorable combined resp rates|6.7|||||TWO_SIDED|95.0|0.3|13.12|||Unstratified Miettinen & Nurminen method|||H0: Difference (CAZ-AVI treatment group minus Doripenem treatment group) of favorable combined response rates ≤ non-inferiority margin||13.12|0.30|
72521765|NCT01599806|144572663|NON_INFERIORITY_OR_EQUIVALENCE|-12.5%|Diff of favorable response rates|6.4|||||TWO_SIDED|95.0|0.33|12.36|||Unstratified Miettinen & Nurminen method|||H0: Difference (CAZ-AVI treatment group minus Doripenem treatment group) of favorable response rates ≤ non-inferiority margin||12.36|0.33|
72521766|NCT01599806|144572664|SUPERIORITY_OR_OTHER||Diff of favorable response rates|0.4|||||TWO_SIDED|95.0|-2.7|3.56|||Unstratified Miettinen & Nurminen method|||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of favorable response rates||3.56|-2.70|
72521767|NCT01599806|144572665|SUPERIORITY_OR_OTHER||Diff of favorable response rates|7.3|||||TWO_SIDED|95.0|0.68|13.81|||Unstratified Miettinen & Nurminen method|||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of favorable response rates||13.81|0.68|
72521768|NCT01599806|144572666|SUPERIORITY_OR_OTHER||Diff of favorable response rates|0.2|||||TWO_SIDED|95.0|-1.21|1.72|||Unstratified Miettinen & Nurminen method|||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of favorable response rates||1.72|-1.21|
72521769|NCT01599806|144572667|SUPERIORITY_OR_OTHER||Diff of favorable response rates|8.8|||||TWO_SIDED|95.0|2.27|15.24|||Unstratified Miettinen & Nurminen method|||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of favorable response rates||15.24|2.27|
72521770|NCT01599806|144572668|SUPERIORITY_OR_OTHER||Diff of favorable response rates|10.9|||||TWO_SIDED|95.0|2.86|18.85|||Unstratified Miettinen & Nurminen method|||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of favorable response rates||18.85|2.86|
72521771|NCT01599806|144572669|SUPERIORITY_OR_OTHER||Diff of favorable response rates|0.2|||||TWO_SIDED|95.0|-1.17|1.68|||Unstratified Miettinen & Nurminen method|||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of favorable response rates||1.68|-1.17|
72521772|NCT01599806|144572670|SUPERIORITY_OR_OTHER||Diff of favorable response rates|7.3|||||TWO_SIDED|95.0|0.88|13.74|||Unstratified Miettinen & Nurminen method|||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of favorable response rates||13.74|0.88|
72521773|NCT01599806|144572671|SUPERIORITY_OR_OTHER||Diff of favorable response rates|9.7|||||TWO_SIDED|95.0|1.72|17.55|||Unstratified Miettinen & Nurminen method|||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of favorable response rates||17.55|1.72|
72521774|NCT01599806|144572672|SUPERIORITY_OR_OTHER||Diff of clinical cure rates|-1.4|||||TWO_SIDED|95.0|-4.07|1.02|||Unstratified Miettinen & Nurminen method|||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of clinical cure rates||1.02|-4.07|
72570136|NCT02504671|144670135|OTHER||Difference|8.1|||||TWO_SIDED|95.0|-5.1|21.3|||||Week 12, ACR70. Difference to Placebo for Week 12 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||21.3|-5.1|
72521775|NCT01599806|144572673|SUPERIORITY_OR_OTHER||Diff of clinical cure rates|-0.1|||||TWO_SIDED|95.0|-4.23|4.03|||Unstratified Miettinen & Nurminen method|||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of clinical cure rates||4.03|-4.23|
72521776|NCT01599806|144572674|SUPERIORITY_OR_OTHER||Diff of clinical cure rates|1.3|||||TWO_SIDED|95.0|-3.71|6.3|||Unstratified Miettinen & Nurminen method|||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of clinical cure rates||6.30|-3.71|
72521777|NCT01599806|144572675|SUPERIORITY_OR_OTHER||Diff of clinical cure rates|-1.3|||||TWO_SIDED|95.0|-3.64|0.55|||Unstratified Miettinen & Nurminen method|||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of clinical cure rates||0.55|-3.64|
72369327|NCT00611026|144248570|SUPERIORITY_OR_OTHER|||||||0.006|TWO_SIDED||||||Cochran-Mantel-Haenszel|P-value was obtained from a Cochran-Mantel-Haenszel test (CMH) with modified ridit scoring and stratified by country.||Treatment difference Tolterodine ER vs placebo at Week 12.||||0.0060
72521778|NCT01599806|144572676|SUPERIORITY_OR_OTHER||Diff of clinical cure rates|1.2|||||TWO_SIDED|95.0|-2.03|4.56|||Unstratified Miettinen & Nurminen method|||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of clinical cure rates||4.56|-2.03|
72521779|NCT01599806|144572677|SUPERIORITY_OR_OTHER||Diff of clinical cure rates|2.2|||||TWO_SIDED|95.0|-2.9|7.24|||Unstratified Miettinen & Nurminen method|||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of clinical cure rates||7.24|-2.90|
72521780|NCT01599806|144572678|SUPERIORITY_OR_OTHER||Diff of clinical cure rates|-1.9|||||TWO_SIDED|95.0|-4.3|0.04|||Unstratified Miettinen & Nurminen method|||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of clinical cure rates||0.04|-4.30|
72521781|NCT01599806|144572679|SUPERIORITY_OR_OTHER||Diff of clinical cure rates|1.1|||||TWO_SIDED|95.0|-2.07|4.32|||Unstratified Miettinen & Nurminen method|||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of clinical cure rates||4.32|-2.07|
72521782|NCT01599806|144572680|SUPERIORITY_OR_OTHER||Diff of clinical cure rates|2.0|||||TWO_SIDED|95.0|-2.94|6.91|||Unstratified Miettinen & Nurminen method|||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of clinical cure rates||6.91|-2.94|
72570137|NCT02504671|144670135|OTHER||Difference|13.5|||||TWO_SIDED|95.0|-1.1|28.1|||||Week 12, ACR70. Difference to Placebo for Week 12 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||28.1|-1.1|
72369328|NCT00611026|144248570|SUPERIORITY_OR_OTHER|||||||0.0016|TWO_SIDED||||||Cochran-Mantel-Haenszel|P-value was obtained from a Cochran-Mantel-Haenszel test (CMH) with modified ridit scoring and stratified by country.||Treatment difference fesoterodine vs Tolterodine ER at Week 12.||||0.0016
72570138|NCT02504671|144670135|OTHER||Difference|13.5|||||TWO_SIDED|95.0|-5.4|32.4|||||Week 16, ACR20. Difference to Placebo for Week 16 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||32.4|-5.4|
72570139|NCT02504671|144670135|OTHER||Difference|29.7|||||TWO_SIDED|95.0|9.8|49.7|||||Week 16, ACR20. Difference to Placebo for Week 16 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||49.7|9.8|
72521783|NCT01599806|144572681|SUPERIORITY_OR_OTHER||Diff of clinical cure rates|-0.1|||||TWO_SIDED|95.0|-1.99|1.61|||Unstratified Miettinen & Nurminen method|||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of clinical cure rates||1.61|-1.99|
72521784|NCT01599806|144572682|SUPERIORITY_OR_OTHER||Diff of clinical cure rates|3.7|||||TWO_SIDED|95.0|0.41|7.16|||Unstratified Miettinen & Nurminen method|||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of clinical cure rates||7.16|0.41|
72521785|NCT01599806|144572683|SUPERIORITY_OR_OTHER||Diff of clinical cure rates|4.0|||||TWO_SIDED|95.0|-1.0|9.05|||Unstratified Miettinen & Nurminen method|||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of clinical cure rates||9.05|-1.00|
72521786|NCT01599806|144572684|SUPERIORITY_OR_OTHER||Diff of clin cure rates in All patients|0.0|||||TWO_SIDED|95.0|-10.4|10.1|||Unstratified Miettinen & Nurminen method|||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of clinical cure rates in All patients with a ceftazidime-resistant Gram-negative pathogen||10.1|-10.4|
72521787|NCT01599806|144572685|SUPERIORITY_OR_OTHER||Diff of clin cure rates in All patients|1.4|||||TWO_SIDED|95.0|-7.8|10.2|||Unstratified Miettinen & Nurminen method|||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of clinical cure rates in All patients with a ceftazidime-resistant Gram-negative pathogen||10.2|-7.8|
72521788|NCT01599806|144572686|SUPERIORITY_OR_OTHER||Diff of clin cure rates in All patients|1.2|||||TWO_SIDED|95.0|-7.5|9.2|||Unstratified Miettinen & Nurminen method|||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of clinical cure rates in All patients with a ceftazidime-resistant Gram-negative pathogen||9.2|-7.5|
72521789|NCT01599806|144572687|SUPERIORITY_OR_OTHER||Diff of favorable response rates|2.0|||||TWO_SIDED|95.0|-13.18|16.89|||Unstratified Miettinen & Nurminen method|||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of favorable response rates||16.89|-13.18|
72521790|NCT01599806|144572688|SUPERIORITY_OR_OTHER||Diff of favorable response rates|8.0|||||TWO_SIDED|95.0|-10.03|25.21|||Unstratified Miettinen & Nurminen method|||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of favorable response rates||25.21|-10.03|
72521791|NCT01599806|144572689|SUPERIORITY_OR_OTHER||Diff of favorable response rates|7.5|||||TWO_SIDED|95.0|-9.91|24.01|||Unstratified Miettinen & Nurminen method|||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of favorable response rates||24.01|-9.91|
72521792|NCT01599806|144572690|SUPERIORITY_OR_OTHER|||||||0.038|||||||Log Rank|||H0: No difference in time to first defervescence between treatment groups.||||0.038
72521793|NCT01599806|144572691|SUPERIORITY_OR_OTHER|||||||0.129|||||||Log Rank|||H0: No difference in time to first defervescence between treatment groups.||||0.129
72521794|NCT01599806|144572692|SUPERIORITY_OR_OTHER|||||||0.08|||||||Log Rank|||H0: No difference in time to first defervescence between treatment groups.||||0.080
72521795|NCT01599806|144572693|SUPERIORITY_OR_OTHER|||||||0.155|||||||Log Rank|||H0: No difference in time to first defervescence between treatment groups.||||0.155
72570140|NCT02504671|144670135|OTHER||Difference|35.1|||||TWO_SIDED|95.0|15.1|55.1|||||Week 16, ACR20. Difference to Placebo for Week 16 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||55.1|15.1|
72521796|NCT01263314|144572763|OTHER||Mean Difference (Final Values)|-1.25||||0.3551|TWO_SIDED|90.0|-7.01|4.5|||ANOVA|||||4.50|-7.01|0.3551
72369329|NCT00611026|144248571|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.1|STANDARD_ERROR_OF_MEAN|1.2|<|0.0001|TWO_SIDED|95.0|-9.5|-4.7|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.|Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.|Treatment difference fesoterodine vs placebo at Week 12.||-4.7|-9.5|<0.0001
72369330|NCT00611026|144248571|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.4|STANDARD_ERROR_OF_MEAN|1.2||0.0458|TWO_SIDED|95.0|-4.8|0.0|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.|Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.|Treatment difference Tolterodine ER vs placebo at Week 12.||-0.0|-4.8|0.0458
72369331|NCT00611026|144248571|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.6|STANDARD_ERROR_OF_MEAN|1.0|<|0.0001|TWO_SIDED|95.0|-6.6|-2.7|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.|Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.|Treatment difference Tolterodine ER vs Fesoterodine at Week 12.||-2.7|-6.6|<0.0001
72521797|NCT01263314|144572763|OTHER||Mean Difference (Final Values)|-1.32||||0.3474|TWO_SIDED|90.0|-7.08|4.48|||ANOVA|||||4.48|-7.08|0.3474
72521798|NCT01263314|144572763|OTHER||Mean Difference (Final Values)|-1.67||||0.3105|TWO_SIDED|90.0|-7.42|4.09|||ANOVA|||||4.09|-7.42|0.3105
72521799|NCT01263314|144572763|OTHER||Mean Difference (Final Values)|-6.25||||0.1346|TWO_SIDED|90.0|-15.8|3.27|||ANOVA|||||3.27|-15.8|0.1346
72521800|NCT01263314|144572763|OTHER||Mean Difference (Final Values)|-10.1||||0.0416|TWO_SIDED|90.0|-19.6|-0.56|||ANOVA|||||-0.56|-19.6|0.0416
72521801|NCT01263314|144572763|OTHER||Mean Difference (Final Values)|-8.2||||0.0762|TWO_SIDED|90.0|-17.7|1.32|||ANOVA|||||1.32|-17.7|0.0762
72570141|NCT02504671|144670135|OTHER||Difference|13.5|||||TWO_SIDED|95.0|-2.4|29.4|||||Week 16, ACR50. Difference to Placebo for Week 16 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||29.4|-2.4|
72570142|NCT02504671|144670135|OTHER||Difference|18.9|||||TWO_SIDED|95.0|2.1|35.7|||||Week 16, ACR50. Difference to Placebo for Week 16 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||35.7|2.1|
72570143|NCT02504671|144670135|OTHER||Difference|18.9|||||TWO_SIDED|95.0|2.1|35.7|||||Week 16, ACR50. Difference to Placebo for Week 16 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||35.7|2.1|
72521802|NCT01263314|144572764|OTHER||Mean Difference (Final Values)|0.47||||0.418|TWO_SIDED|90.0|-3.47|4.41|||ANOVA|||||4.41|-3.47|0.418
72521803|NCT01263314|144572764|OTHER||Mean Difference (Final Values)|4.12||||0.0434|TWO_SIDED|90.0|0.18|8.05|||ANOVA|||||8.05|0.18|0.0434
72521804|NCT01263314|144572764|OTHER||Mean Difference (Final Values)|7.79||||0.0019|TWO_SIDED|90.0|3.85|11.72|||ANOVA|||||11.72|3.85|0.0019
72521805|NCT01263314|144572764|OTHER||Mean Difference (Final Values)|1.15||||0.2223|TWO_SIDED|90.0|-1.42|3.71|||ANOVA|||||3.71|-1.42|0.2223
72521806|NCT01263314|144572764|OTHER||Mean Difference (Final Values)|4.25||||0.0056|TWO_SIDED|90.0|1.69|6.82|||ANOVA|||||6.82|1.69|0.0056
72521807|NCT01263314|144572764|OTHER||Mean Difference (Final Values)|5.4||||0.0012|TWO_SIDED|90.0|2.83|7.96|||ANOVA|||||7.96|2.83|0.0012
72521808|NCT01263314|144572766|OTHER||GMR (Elderly female/Elderly male)|1.23|||||TWO_SIDED|90.0|0.85|1.76|||||GMR = geometric mean ratio|||1.76|0.85|
72521809|NCT01263314|144572767|OTHER||GMR (Elderly female/Elderly male)|1.08|||||TWO_SIDED|90.0|0.88|1.33||||||||1.33|0.88|
72521810|NCT01263314|144572767|OTHER||GMR (Elderly female/Elderly male)|1.26|||||TWO_SIDED|90.0|1.02|1.55||||||||1.55|1.02|
72570144|NCT02504671|144670135|OTHER||Difference|-2.7|||||TWO_SIDED|95.0|-11.7|6.3|||||Week 16, ACR70. Difference to Placebo for Week 16 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||6.3|-11.7|
72521811|NCT01263314|144572767|OTHER||GMR (Elderly female/Elderly male)|1.2|||||TWO_SIDED|90.0|0.98|1.48||||||||1.48|0.98|
72521812|NCT01263314|144572770|SUPERIORITY||MK-8266 0.3 mg vs. placebo|9.58||||0.0253|TWO_SIDED|90.0|1.69|17.46|||ANOVA|||||17.46|1.69|0.0253
72570145|NCT02504671|144670135|OTHER||Difference|8.1|||||TWO_SIDED|95.0|-5.1|21.3|||||Week 16, ACR70. Difference to Placebo for Week 16 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||21.3|-5.1|
72521813|NCT01263314|144572770|SUPERIORITY||MK-8266 0.6 mg vs. placebo|-2.59||||0.2856|TWO_SIDED|90.0|-10.5|5.29|||ANOVA|||||5.29|-10.5|0.2856
72521814|NCT01263314|144572770|SUPERIORITY||MK-8266 0.7 mg/ 0.3 mg vs. placebo|-4.06||||0.1895|TWO_SIDED|90.0|-11.9|3.82|||ANOVA|||||3.82|-11.9|0.1895
72521815|NCT01263314|144572770|SUPERIORITY||MK-8266 0.3 mg vs. placebo|-4.16||||0.1157|TWO_SIDED|90.0|-10.0|1.7|||ANOVA|||||1.70|-10.0|0.1157
72521816|NCT01263314|144572770|SUPERIORITY||MK-8266 0.6 mg vs. placebo|-11.7||||0.0018|TWO_SIDED|90.0|-17.5|-5.79|||ANOVA|||||-5.79|-17.5|0.0018
72521817|NCT01263314|144572770|SUPERIORITY||MK-8266 0.7 mg/ 0.3 mg vs. placebo|-10.6||||0.0034|TWO_SIDED|90.0|-16.5|-4.77|||ANOVA|||||-4.77|-16.5|0.0034
72521818|NCT00282568|144572771|NON_INFERIORITY_OR_EQUIVALENCE|If the 90% Confidence Interval for the ratio of the natural log-transformed pharmacokinetic parameters fell within an 80% to 125% range, then the exposure between the two formulations was considered to be equivalent.|Ratio of means|94.97|||||TWO_SIDED|90.0|90.72|99.41|||||Tacrolimus/tacrolimus MR ratio of natural log transformed means expressed as a percent.|The method of analysis of variance with repeated measures was used for the comparisons of AUC0-24. Exposure at steady state was used for tacrolimus (steady state was defined as days 1 and 7) and for tacrolimus MR (steady state was defined as days 14 and 21). The natural log (ln) was used to transform AUC0-24 prior to analysis and the results were transformed back to the original scale for the presentation of results.||99.41|90.72|
72521819|NCT00282568|144572773|NON_INFERIORITY_OR_EQUIVALENCE|If the 90% CI for the ratio of the natural log-transformed pharmacokinetic parameters fell within an 80% to 125% range, then the exposure between the two formulations was considered to be equivalent.|Ratio of means|88.15|||||TWO_SIDED|90.0|82.69|93.96|||||Tacrolimus/tacrolimus MR ratio of natural log transformed means expressed as a percent.|The method of analysis of variance with repeated measures was used for the comparisons of Cmax. Exposure at steady state was used for tacrolimus (steady state was defined as days 1 and 7) and for tacrolimus MR (steady state was defined as days 14 and 21). The natural log (ln) was used to transform Cmax prior to analysis and the results were transformed back to the original scale for the presentation of results.||93.96|82.69|
72521820|NCT00282568|144572774|NON_INFERIORITY_OR_EQUIVALENCE|If the 90% CI for the ratio of the natural log-transformed pharmacokinetic parameters fell within an 80% to 125% range, then the exposure between the two formulations was considered to be equivalent.|Ratio of means|87.2|||||TWO_SIDED|90.0|82.72|91.93|||||Tacrolimus/tacrolimus MR ratio of natural log transformed means expressed as a percent.|The method of analysis of variance with repeated measures was used for the comparisons of Cmin. Exposure at steady state was used for tacrolimus (steady state was defined as days 1 and 7) and for tacrolimus MR (steady state was defined as days 14 and 21). The natural log (ln) was used to transform Cmin prior to analysis and the results were transformed back to the original scale for the presentation of results.||91.93|82.72|
72521821|NCT02417064|144572794|SUPERIORITY||Difference of Least Square (LS) Means|-3.2||||0.088|TWO_SIDED|95.0|-6.88|0.45|||Mixed Model for Repeated Measures|||||0.45|-6.88|0.088
72521822|NCT02417064|144572794|SUPERIORITY||Difference of Least Square (LS) Means|-4.1|||||TWO_SIDED|95.0|-7.67|-0.49||||||||-0.49|-7.67|
72521823|NCT02417064|144572795|SUPERIORITY||Difference of Least Square (LS) Means|-2.0|||=|0.25|TWO_SIDED|95.0|-5.52|1.42|||ANCOVA|||||1.42|-5.52|= 0.250
72521824|NCT02417064|144572795|SUPERIORITY||Difference of Least Square (LS) Means|-4.1|||||TWO_SIDED|95.0|-7.53|-0.6||||||||-0.6|-7.53|
72570146|NCT02504671|144670135|OTHER||Difference|13.5|||||TWO_SIDED|95.0|-1.1|28.1|||||Week 16, ACR70. Difference to Placebo for Week 16 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||28.1|-1.1|
72570147|NCT02504671|144670135|OTHER||Difference|8.1|||||TWO_SIDED|95.0|-10.1|26.3|||||Week 20, ACR20. Difference to Placebo for Week 20 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||26.3|-10.1|
72570148|NCT02504671|144670135|OTHER||Difference|21.6|||||TWO_SIDED|95.0|2.0|41.2|||||Week 20, ACR20. Difference to Placebo for Week 20 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||41.2|2.0|
72570149|NCT02504671|144670135|OTHER||Difference|37.8|||||TWO_SIDED|95.0|17.9|57.8|||||Week 20, ACR20. Difference to Placebo for Week 20 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||57.8|17.9|
72570150|NCT02504671|144670135|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-10.6|16.0|||||Week 20, ACR50. Difference to Placebo for Week 20 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||16.0|-10.6|
72406029|NCT00653224|144320375|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.76|||<|0.001||95.0|-1.18|-0.35||If the p-value of this estimated difference is lower than 5% the mean T4SS is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the Mean T4SS including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean T4SS over Week 2 is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.35|-1.18|<0.001
72406030|NCT00653224|144320376|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.81|||<|0.001||95.0|-1.17|-0.45||If the p-value of this estimated difference is lower than 5% the mean T4SS is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the Mean T4SS including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean T4SS over the total treatment period is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.45|-1.17|<0.001
72406031|NCT00653224|144320377|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.74|||<|0.001||95.0|-1.17|-0.31||If the p-value of this estimated difference is lower than 5% the mean TNSS is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the Mean TNSS including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean TNSS over Week 1 is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.31|-1.17|<0.001
72406032|NCT00653224|144320378|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.74||||0.005||95.0|-1.26|-0.22||If the p-value of this estimated difference is lower than 5% the mean TNSS is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the Mean TNSS including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean TNSS over Week 2 is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.22|-1.26|0.005
72521825|NCT01585168|144572810|OTHER||Mean Difference (Net)|2.4109||||0.032|TWO_SIDED|||||P value was adjusted for multiple comparisons using FWE (family wise error) correction.|t-test, 2 sided|A Paired t-test was performed to explore the difference between two groups.|FHN was found to have lower mean BOLD activation while given drug compared to placebo in amygdala.|||||0.032
72521826|NCT01585168|144572810|OTHER||Median Difference (Net)|3.6615||||0.125|TWO_SIDED||||||t-test, 2 sided|||||||0.125
72521827|NCT01585168|144572813|OTHER||Mean Difference (Net)|2.7264||||0.356|TWO_SIDED|||||P value was adjusted for multiple comparisons using FWE (family wise error) correction.|t-test, 2 sided||FHP was found to have lower mean BOLD activation while given drug compared to placebo in anterior cingulate cortex.|||||0.356
72521828|NCT01585168|144572813|OTHER||Median Difference (Net)|1.8348||||0.009|TWO_SIDED||||||t-test, 2 sided|||||||0.009
72521829|NCT01235507|144572842|SUPERIORITY_OR_OTHER||||||<|0.0005|TWO_SIDED||||||Wilcoxon signed rank test|||Change from Baseline to Week 8||||<0.0005
72521830|NCT01235507|144572842|SUPERIORITY_OR_OTHER||||||<|0.0005|TWO_SIDED||||||Wilcoxon signed rank test|||Change from Baseline to Week 16||||<0.0005
72521831|NCT01235507|144572842|SUPERIORITY_OR_OTHER||||||<|0.0005|TWO_SIDED||||||Wilcoxon signed rank test|||Change from Baseline to Week 24||||<0.0005
72521832|NCT01235507|144572844|SUPERIORITY_OR_OTHER||||||<|0.0005|TWO_SIDED||||||Wilcoxon signed rank test|||Change from Baseline to Week 8||||<0.0005
72521833|NCT01235507|144572844|SUPERIORITY_OR_OTHER||||||<|0.0005|TWO_SIDED||||||Wilcoxon signed rank test|||Change from Baseline to Week 16||||<0.0005
72521834|NCT01235507|144572844|SUPERIORITY_OR_OTHER||||||<|0.0005|TWO_SIDED||||||Wilcoxon signed rank test|||Change from Baseline to Week 24||||<0.0005
72521835|NCT01235507|144572845|SUPERIORITY_OR_OTHER||||||<|0.0005|TWO_SIDED||||||Wilcoxon signed rank test|||Change from Baseline to Week 8||||<0.0005
72521836|NCT01235507|144572845|SUPERIORITY_OR_OTHER||||||<|0.0005|TWO_SIDED||||||Wilcoxon signed rank test|||Change from Baseline to Week 16||||<0.0005
72521837|NCT01235507|144572845|SUPERIORITY_OR_OTHER||||||<|0.0005|TWO_SIDED||||||Wilcoxon signed rank test|||Change from Baseline to Week 24||||<0.0005
72521838|NCT01235507|144572846|SUPERIORITY_OR_OTHER||||||<|0.0005|TWO_SIDED||||||Wilcoxon signed rank test|||Change from Baseline to Week 8||||<0.0005
72521839|NCT01235507|144572846|SUPERIORITY_OR_OTHER||||||<|0.0005|TWO_SIDED||||||Wilcoxon signed rank test|||Change from Baseline to Week 16||||<0.0005
72521840|NCT01235507|144572846|SUPERIORITY_OR_OTHER||||||<|0.0005|TWO_SIDED||||||Wilcoxon signed rank test|||Change from Baseline to Week 24||||<0.0005
72521841|NCT01235507|144572847|SUPERIORITY_OR_OTHER||||||<|0.0005|TWO_SIDED||||||Wilcoxon signed rank test|||Change from Baseline to Week 8||||<0.0005
72521842|NCT01235507|144572847|SUPERIORITY_OR_OTHER||||||<|0.0005|TWO_SIDED||||||Wilcoxon signed rank test|||Change from Baseline to Week 16||||<0.0005
72521843|NCT01235507|144572847|SUPERIORITY_OR_OTHER||||||<|0.0005|TWO_SIDED||||||Wilcoxon signed rank test|||Change from Baseline to Week 24||||<0.0005
72521844|NCT01235507|144572848|SUPERIORITY_OR_OTHER||||||<|0.0005|TWO_SIDED||||||Wilcoxon signed rank test|||Change from Baseline to Week 8||||<0.0005
72521845|NCT01235507|144572848|SUPERIORITY_OR_OTHER||||||<|0.0005|TWO_SIDED||||||Wilcoxon signed rank test|||Change from Baseline to Week 16||||<0.0005
72521846|NCT01235507|144572848|SUPERIORITY_OR_OTHER||||||<|0.0005|TWO_SIDED||||||Wilcoxon signed rank test|||Change from Baseline to Week 24||||<0.0005
72521847|NCT01235507|144572849|SUPERIORITY_OR_OTHER||||||<|0.0005|TWO_SIDED||||||Wilcoxon signed rank test|||Change from Baseline to Week 8||||<0.0005
72521848|NCT01235507|144572849|SUPERIORITY_OR_OTHER||||||<|0.0005|TWO_SIDED||||||Wilcoxon signed rank test|||Change from Baseline to Week 16||||<0.0005
72521849|NCT01235507|144572849|SUPERIORITY_OR_OTHER||||||<|0.0005|TWO_SIDED||||||Wilcoxon signed rank test|||Change from Baseline to Week 24||||<0.0005
72521850|NCT01363258|144572857|OTHER|Generalized linear mixed models fitted with binomial (logit link) and gamma (log link) distributions, with additional dispersion parameters, were used to estimate and test intervention effects in terms of occurrence and intensity of CRBs, respectively. Inference was conducted in the link scale, but inverse-link estimates in the original scales (proportions and CRB scores, for the binomial and gamma models, respectively) were computed to facilitate interpretation.|Effect size|-0.16||||0.1433|TWO_SIDED||||||Time by group interaction test|||||||0.1433
72521851|NCT00918346|144572872|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence limit was set to 1.5 mmHg. Equivalence was shown if the two-sided 95% confidence interval for the difference (unpreserved-preserved) lay entirely within the equivalence range (-1.5 mmHg, 1.5 mmHg). Target sample size was 34 evaluable patients (40 randomized), assuming a standard deviation of 3.0 mmHg change in IOP, a power of 80%, an intra-class correlation coefficient of 0.60 and a twosided type 1 error rate of 5%.|Mean Difference (Final Values)|0.01||||0.96||95.0|-0.46|0.49|||ANCOVA|Baseline IOP a covariate|Analysis model used IOP measurements at four timepoints (at 8, 12, 16 and 20 o'clock) on Baseline and Week 4.|H1 (the alternative hypothesis aimed to be proven): the unpreserved formulation is equivalent with the preserved formulation||0.49|-0.46|0.96
72521852|NCT00918346|144572873|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence limit was set to 1.5 mmHg. Equivalence was shown if the two-sided 95% confidence interval for the difference (unpreserved-preserved) lay entirely within the equivalence range (-1.5 mmHg, 1.5 mmHg). Target sample size was 34 evaluable patients (40 randomized), assuming a standard deviation of 3.0 mmHg change in IOP, a power of 80%, an intra-class correlation coefficient of 0.60 and a twosided type I error rate of 5%.|Median Difference (Final Values)|-0.05||||0.83||95.0|-0.52|0.42|||ANCOVA|Baseline IOP a covariate|Analysis model used IOP measurements at four timepoints (at 8, 12, 16 and 20 o'clock) on Baseline and Week 4|H1 (the alternative hypothesis aimed to be proven): the unpreserved formulation is equivalent with the preserved formulation||0.42|-0.52|0.83
72521853|NCT02754661|144572902|NON_INFERIORITY|The non-inferiority margin (δ) is pre-defined to be 5% in this study. Posterior Probability was based on Bayesian analysis.|Posterior Probability Bayesian analysis|0.9999|||||TWO_SIDED||||||||Support the claim of statistical non-inferiority of CCE vs CTC|||||
72521854|NCT02754661|144572903|NON_INFERIORITY|Non-inferiority margin was set as 10%|Risk Difference (RD)|0.3732|||<|0.0001|TWO_SIDED|90.0|0.203|0.5434|||Farrington-Manning test||Based on Farrington-Manning Method|||0.5434|0.2030|<0.0001
72521855|NCT02754661|144572904|NON_INFERIORITY|Non-inferiority margin was set as 10%|Risk Difference (RD)|-0.026||||0.019|TWO_SIDED|90.0|-0.0847|0.0327|||Farrington-Manning test||Based on Farrington-Manning Method|||0.0327|-0.0847|0.0190
72521856|NCT02754661|144572905|NON_INFERIORITY|Non-inferiority margin was set as 10%|Risk Difference (RD)|0.0023||||0.093|TWO_SIDED|90.0|-0.1249|0.1249|||Farrington-Manning test||Based on Farrington-Manning Method|||0.1249|-0.1249|0.0930
72521857|NCT02754661|144572906|NON_INFERIORITY|Non-inferiority margin was set as 10%|Risk Difference (RD)|0.0607||||0.0034|TWO_SIDED|90.0|-0.0371|0.1585|||Farrington-Manning test||Based on Farrington-Manning Method|||0.1585|-0.0371|0.0034
72570151|NCT02504671|144670135|OTHER||Difference|16.2|||||TWO_SIDED|95.0|-0.2|32.6|||||Week 20, ACR50. Difference to Placebo for Week 20 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||32.6|-0.2|
72570152|NCT02504671|144670135|OTHER||Difference|13.5|||||TWO_SIDED|95.0|-2.4|29.4|||||Week 20, ACR50. Difference to Placebo for Week 20 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||29.4|-2.4|
72521858|NCT04423757|144572907|OTHER||Adjusted mean difference|3.38|STANDARD_ERROR_OF_MEAN|3.1||0.2796|TWO_SIDED|90.0|-1.81|8.56|||Mixed Models Analysis||Difference calculated as BI - Placebo.|Mixed effects model for repeated measures (MMRM) with fixed effects of treatment, visit, treatment by visit interaction, baseline, and baseline by visit interaction; patient as a random effect; unstructured covariance matrix for within-patient errors and Kenward-Roger approximation for denominator degrees of freedom.||8.56|-1.81|0.2796
72521859|NCT04423757|144572908|OTHER||Odds Ratio (OR)|0.276||||0.0468|TWO_SIDED|90.0|0.091|0.781|||Regression, Logistic||For the calculation of the odds ratio Placebo is taken as reference.|Logistic regression includes treatment as covariate.||0.781|0.091|0.0468
72570153|NCT02504671|144670135|OTHER||Difference|-2.7|||||TWO_SIDED|95.0|-11.7|6.3|||||Week 20, ACR70. Difference to Placebo for Week 20 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||6.3|-11.7|
72570154|NCT02504671|144670135|OTHER||Difference|10.8|||||TWO_SIDED|95.0|-3.1|24.7|||||Week 20, ACR70. Difference to Placebo for Week 20 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||24.7|-3.1|
72570155|NCT02504671|144670135|OTHER||Difference|8.1|||||TWO_SIDED|95.0|-5.1|21.3|||||Week 20, ACR70. Difference to Placebo for Week 20 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||21.3|-5.1|
72521860|NCT04423757|144572909|OTHER||Adjusted mean difference|1.35|STANDARD_ERROR_OF_MEAN|3.5||0.698|TWO_SIDED|90.0|-4.47|7.17|||Mixed Models Analysis||Difference calculated as BI - Placebo.|S-Anxiety scale - Mixed effects model for repeated measures (MMRM) with fixed effects of treatment, visit, treatment by visit interaction, baseline, and baseline by visit interaction; patient as a random effect; unstructured covariance matrix for within-patient errors and Kenward-Roger approximation for denominator degrees of freedom.||7.17|-4.47|0.6980
72521861|NCT04423757|144572909|OTHER||Adjusted mean difference|3.54|STANDARD_ERROR_OF_MEAN|3.1||0.2589|TWO_SIDED|90.0|-1.67|8.76|||Mixed Models Analysis||Difference calculated as BI - Placebo.|T-Anxiety scale - Mixed effects model for repeated measures (MMRM) with fixed effects of treatment, visit, treatment by visit interaction, baseline, and baseline by visit interaction; patient as a random effect; unstructured covariance matrix for within-patient errors and Kenward-Roger approximation for denominator degrees of freedom.||8.76|-1.67|0.2589
72570156|NCT02504671|144670135|OTHER||Difference|10.8|||||TWO_SIDED|95.0|-6.9|28.5|||||Week 24, ACR20. Difference to Placebo for Week 24 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||28.5|-6.9|
72570157|NCT02504671|144670135|OTHER||Difference|27.0|||||TWO_SIDED|95.0|7.7|46.3|||||Week 24, ACR20. Difference to Placebo for Week 24 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||46.3|7.7|
72570158|NCT02504671|144670135|OTHER||Difference|43.2|||||TWO_SIDED|95.0|23.8|62.6|||||Week 24, ACR20. Difference to Placebo for Week 24 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||62.6|23.8|
72570159|NCT02504671|144670135|OTHER||Difference|0.0|||||TWO_SIDED|95.0|-14.1|14.1|||||Week 24, ACR50. Difference to Placebo for Week 24 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||14.1|-14.1|
72570160|NCT02504671|144670135|OTHER||Difference|16.2|||||TWO_SIDED|95.0|-1.2|33.7|||||Week 24, ACR50. Difference to Placebo for Week 24 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||33.7|-1.2|
72406033|NCT00653224|144320379|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.74|||<|0.001||95.0|-1.18|-0.3||If the p-value of this estimated difference is lower than 5% the mean TNSS is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the Mean TNSS including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean TNSS over the total treatment period is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.30|-1.18|<0.001
72406034|NCT00653224|144320380|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.59|||<|0.001||95.0|-0.87|-0.3||If the p-value of this estimated difference is lower than 5% the mean TOSS is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the Mean TOSS including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean TOSS over Week 1 is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.30|-0.87|<0.001
72521862|NCT04423757|144572910|OTHER||Adjusted mean difference|0.51|STANDARD_ERROR_OF_MEAN|0.4||0.1863|TWO_SIDED|90.0|-0.13|1.15|||Mixed Models Analysis||Difference calculated as BI - Placebo.|Mixed effects model for repeated measures (MMRM) with fixed effects of treatment, visit, treatment by visit interaction, baseline, and baseline by visit interaction; patient as a random effect; unstructured covariance matrix for within-patient errors and Kenward-Roger approximation for denominator degrees of freedom.||1.15|-0.13|0.1863
72521863|NCT04423757|144572911|OTHER||Adjusted mean difference|0.65|STANDARD_ERROR_OF_MEAN|3.1||0.8326|TWO_SIDED|90.0|-4.46|5.76|||Mixed Models Analysis||Difference calculated as BI - Placebo.|Mixed effects model for repeated measures (MMRM) with fixed effects of treatment, visit, treatment by visit interaction, baseline, and baseline by visit interaction; patient as a random effect; unstructured covariance matrix for within-patient errors and Kenward-Roger approximation for denominator degrees of freedom.||5.76|-4.46|0.8326
72521864|NCT04423757|144572912|OTHER||Adjusted mean difference|0.23|STANDARD_ERROR_OF_MEAN|0.4||0.5567|TWO_SIDED|90.0|-0.43|0.89|||Mixed Models Analysis||Difference calculated as BI - Placebo.|Mixed effects model for repeated measures (MMRM) with fixed effects of treatment, visit, treatment by visit interaction, baseline, and baseline by visit interaction; patient as a random effect; unstructured covariance matrix for within-patient errors and Kenward-Roger approximation for denominator degrees of freedom.||0.89|-0.43|0.5567
72521865|NCT02709109|144572915|SUPERIORITY||Least Square (LS) mean difference|0.2||||0.8173|TWO_SIDED|95.0|-1.4|1.8|||Mixed-effects Model for Repeated Measure|||||1.8|-1.4|0.8173
72521866|NCT02709109|144572915|SUPERIORITY||LS mean difference|-0.7||||0.5903|TWO_SIDED|95.0|-3.3|1.9|||Mixed-effects Model for Repeated Measure|||||1.9|-3.3|0.5903
72521867|NCT02709109|144572915|SUPERIORITY||LS mean difference|-0.7||||0.5917|TWO_SIDED|95.0|-3.4|1.9|||Mixed-effects Model for Repeated Measure|||||1.9|-3.4|0.5917
72521868|NCT02709109|144572915|SUPERIORITY||LS mean difference|-0.9||||0.5021|TWO_SIDED|95.0|-3.6|1.8|||Mixed-effects Model for Repeated Measure|||||1.8|-3.6|0.5021
72521869|NCT02709109|144572915|SUPERIORITY||LS mean difference|-1.6||||0.1382|TWO_SIDED|95.0|-3.8|0.5|||Mixed-effects Model for Repeated Measure|||||0.5|-3.8|0.1382
72521870|NCT02709109|144572915|SUPERIORITY||LS mean difference|0.9||||0.4962|TWO_SIDED|95.0|-1.7|3.5|||Mixed-effects Model for Repeated Measure|||||3.5|-1.7|0.4962
72521871|NCT00996593|144572918|SUPERIORITY_OR_OTHER||Percentage of participants|65.0|||||TWO_SIDED|95.0|50.0|80.0|||||The estimated value represents the percentage of participants with complete response.|||80|50|
72521872|NCT00996593|144572919|SUPERIORITY_OR_OTHER||Percentage of participants|23.0|||||TWO_SIDED|95.0|10.0|35.0|||||The estimated value represents the percentage of participants with complete response.|||35|10|
72521873|NCT00996593|144572920|SUPERIORITY_OR_OTHER||Percentage of participants|38.0|||||TWO_SIDED|95.0|22.0|53.0|||||The estimated value represents the percentage of participants with complete response.|||53|22|
72521874|NCT00996593|144572921|SUPERIORITY_OR_OTHER||Percentage of participants|28.0|||||TWO_SIDED|95.0|14.0|41.0|||||The estimated value represents the percentage of participants with complete response.|||41|14|
72521875|NCT00996593|144572926|SUPERIORITY_OR_OTHER||Percentage of responders|75.0||||1|TWO_SIDED|95.0|54.0|96.0||With prior response|Fisher Exact||The estimated value represents the percentage of participants with response.|||96|54|1.0
72521876|NCT00996593|144572926|SUPERIORITY_OR_OTHER||Percentage of responders|70.0||||1|TWO_SIDED|95.0|51.0|88.0||Without prior response|Fisher Exact||The estimated value represents the percentage of participants with response.|||88|51|1.0
72521877|NCT00996593|144572927|SUPERIORITY_OR_OTHER|||||||0.8||95.0|||||Fisher Exact|||||||0.8
72406035|NCT00653224|144320381|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.57|||<|0.001||95.0|-0.91|-0.24||If the p-value of this estimated difference is lower than 5% the mean TOSS is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the Mean TOSS including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean TOSS over Week 2 is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.24|-0.91|<0.001
72521878|NCT00996593|144572928|SUPERIORITY_OR_OTHER||Percentage of responders|31.0||||1|TWO_SIDED|95.0|9.0|54.0||With prior response|Fisher Exact||The estimated value represents the percentage of participants with response.|||54|9|1.0
72521879|NCT00996593|144572928|SUPERIORITY_OR_OTHER||Percentage of responders|17.0||||1|TWO_SIDED|95.0|2.0|33.0||Without prior response|Fisher Exact||The estimated value represents the percentage of participants with response.|||33|2|1.0
72521880|NCT00996593|144572929|SUPERIORITY_OR_OTHER|||||||0.2||95.0|||||Fisher Exact|||||||0.2
72521881|NCT00996593|144572930|SUPERIORITY_OR_OTHER|||||||0.9||95.0|||||Log Rank|||||||0.9
72542524|NCT01010230|144614888|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.24||||0.69|TWO_SIDED|95.0|-5.59|3.11||The threshold for significance was established a priori at alpha=0.05.|ANOVA|BMC was normalized for height and adjusted for sex and tanner stage.||The power estimates were based on two-sided two-sample t-tests. With 30 subjects in each of the two arms and assuming no change in the control arm (0% change) and assuming the common standard deviation (SD) of 6.8% we estimated 87% power to detect an improvement of 5.5% change in the intervention arm, with type I error control α=0.05.||3.11|-5.59|0.69
72570161|NCT02504671|144670135|OTHER||Difference|18.9|||||TWO_SIDED|95.0|1.1|36.7|||||Week 24, ACR50. Difference to Placebo for Week 24 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||36.7|1.1|
72521882|NCT00583661|144572960|NON_INFERIORITY_OR_EQUIVALENCE|Sample size determination: A sample of 24 subjects followed for approximately 100 days provides greater than 80% power to conclude that, with a 1-sided alpha=0.025 test, the SAE rate of the EXCOR (assumed to be 0.21 per patient-day) is less than 0.25 per patient-day. This sample size was estimated using 10,000 simulations of this study. A total enrollment of 48 subjects (24 per cohort) were enrolled and implanted with the EXCOR® Pediatric.|Poisson confidence interval|0.25|||<|0.05|TWO_SIDED|95.0|0.0|0.25||A Poisson exact confidence interval was calculated and the critical-value method was used for the significance testing. Success was defined as the upper bound of the 95% Poisson exact confidence interval being less than 0.25.|Poisson confidence interval|||Ho: EXCOR® SAE Rate \>=0.25 Ha: EXCOR® SAE Rate \< 0.25 Where serious adverse event (SAE) rate is calculated as the total number of serious adverse events divided by the sum of days all patients are on the EXCOR® Pediatric device, and 0.25 serious adverse events per patient-day is the success criterion. Study success in terms of safety will be demonstrated by the upper bound of a two-sided 95% Poisson exact confidence interval being less than 0.25.||0.25|0|<0.05
72570162|NCT02504671|144670135|OTHER||Difference|0.0|||||TWO_SIDED|95.0|-10.3|10.3|||||Week 24, ACR70. Difference to Placebo for Week 24 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||10.3|-10.3|
72570163|NCT02504671|144670135|OTHER||Difference|8.1|||||TWO_SIDED|95.0|-5.1|21.3|||||Week 24, ACR70. Difference to Placebo for Week 24 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||21.3|-5.1|
72625026|NCT03978598|144779588|NON_INFERIORITY|We used a 15% difference in our primary outcome for the non-inferiority margin as this is the upper end of the estimated prevalence of lactation failure in the literature and is consistent with previous studies (Neifert 2001, Gurtcheff 2011, Turok 2017).|Risk Difference (RD)|3.7|||||ONE_SIDED|95.0|-16.7|||||||To achieve 80% power with a 1-sided type 1 error of 5% utilizing the Z-test (unpooled), 62 participants would be required in each group, for a total of 124 participants. Accounting for expected loss to follow-up of 20%, we aimed to recruit 149 participants and rounded up to final recruitment goal of 150.|The risk-difference between immediate and standard placement in the modified intention-to-treat analysis (mITT) was -0.6% with a -12.8% lower limit of the 95% confidence interval. In the mITT analysis, 78.3% (54/69) and 78.9% (45/57) of participants were breastfeeding at 8 weeks in the immediate and delayed groups, respectively.||-16.7|
72521883|NCT04010370|144572963|SUPERIORITY||||||<|0.001|||||||Spearman correlation|||Correlation of McAuley index with PREDIM index at baseline.||||<0.001
72521884|NCT04010370|144572964|SUPERIORITY|||||||0.319|||||||Spearman correlation|||Correlation of Belfiore index with PREDIM index at baseline.||||0.319
72521885|NCT04010370|144572965|SUPERIORITY|||||||0.27|||||||Spearman correlation|||Correlation of Cederholm index with PREDIM index at baseline.||||0.27
72521886|NCT04010370|144572966|SUPERIORITY|||||||0.246|||||||Spearman correlation|||Correlation of Avignon index with PREDIM index at baseline.||||0.246
72570164|NCT02504671|144670135|OTHER||Difference|8.1|||||TWO_SIDED|95.0|-5.1|21.3|||||Week 24, ACR70. Difference to Placebo for Week 24 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||21.3|-5.1|
72625027|NCT01425814|144779661|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.259|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001|TWO_SIDED|95.0|0.219|0.298|||ANCOVA|||||0.298|0.219|<0.0001
72625028|NCT01425814|144779661|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.233|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001|TWO_SIDED|95.0|0.194|0.273|||ANCOVA|||||0.273|0.194|<0.0001
72625029|NCT01425814|144779661|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.203|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001|TWO_SIDED|95.0|0.164|0.242|||ANCOVA|||||0.242|0.164|<0.0001
72625030|NCT01425814|144779661|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.102|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001|TWO_SIDED|95.0|0.062|0.141|||ANCOVA|||||0.141|0.062|<0.0001
72521887|NCT04010370|144572967|SUPERIORITY|||||||0.259|||||||Spearman correlation|||Correlation of Matsuda index with PREDIM index at baseline.||||0.259
72521888|NCT04010370|144572968|SUPERIORITY|||||||0.69|||||||Spearman correlation|||Correlation of Gutt index with PREDIM index at baseline.||||0.69
72521889|NCT04010370|144572969|SUPERIORITY|||||||0.022|||||||Spearman correlation|||Correlation of Stumvoll index with PREDIM index at baseline.||||0.022
72521890|NCT04010370|144572970|SUPERIORITY|||||||0.69|||||||Spearman correlation|||Correlation of HOMA-IR index with PREDIM index at baseline.||||0.69
72521891|NCT04010370|144572971|SUPERIORITY|||||||0.69|||||||Spearman correlation|||Correlation of ISI index with PREDIM index at baseline.||||0.69
72521892|NCT04010370|144572972|SUPERIORITY|||||||0.541|||||||Spearman correlation|||Correlation of Raynaud index with PREDIM index at baseline.||||0.541
72521893|NCT04010370|144572973|SUPERIORITY|||||||0.69|||||||Spearman correlation|||Correlation of QUICKI index with PREDIM index at baseline.||||0.69
72521894|NCT04010370|144572974|SUPERIORITY|||||||0.531|||||||Spearman correlation|||Correlation of FIRI index with PREDIM index at baseline.||||0.531
72521895|NCT04010370|144572975|SUPERIORITY|||||||0.726|||||||Spearman correlation|||Correlation of Bennett index with PREDIM index at baseline.||||0.726
72570165|NCT02504671|144670135|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-4.8|15.6|||||Week 28, ACR20. Difference to Placebo for Week 28 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||15.6|-4.8|
72570166|NCT02504671|144670135|OTHER||Difference|16.2|||||TWO_SIDED|95.0|2.6|29.9|||||Week 28, ACR20. Difference to Placebo for Week 28 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||29.9|2.6|
72570167|NCT02504671|144670135|OTHER||Difference|16.2|||||TWO_SIDED|95.0|2.6|29.9|||||Week 28, ACR20. Difference to Placebo for Week 28 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||29.9|2.6|
72625031|NCT02138825|144779688|SUPERIORITY_OR_OTHER||LS mean difference|21.48||||0.2074|TWO_SIDED|95.0|-8.75|51.71|||ANCOVA|||The evaluation of primary efficacy endpoint will be based on change from baseline in 6MWD using analysis of covariance (ANCOVA) with baseline 6MWD, treatment arm and region as factors.||51.71|-8.75|0.2074
72625032|NCT02138825|144779689|SUPERIORITY_OR_OTHER|||||||0.3437|||||||Mantel Haenszel|||The difference in incidences in clinical worsening and mortality will be analyzed using Mantel-Haenszel weights, stratified by region.||||0.3437
72521896|NCT04010370|144572976|SUPERIORITY|||||||0.787|||||||Spearman correlation|||Correlation of TyG index with PREDIM index at baseline.||||0.787
72521897|NCT05563714|144572977|SUPERIORITY||Odds Ratio (OR)|5.22|||<|0.001|TWO_SIDED|95.0|2.41|11.33|||generalized linear mixed effects model||Adjusted OR (base model)|Adjusted OR (base model), 95% CI - Includes clinician proceduralist vs non-proceduralist status as a co-variate.||11.33|2.41|<0.001
72521898|NCT05563714|144572977|SUPERIORITY||Odds Ratio (OR)|5.76|||<|0.001|TWO_SIDED|95.0|2.54|13.05|||generalized linear mixed effects model||Adjusted OR (expanded model)|Adjusted OR (expanded model), 95% CI - Adjusted for clinician proceduralist vs non-proceduralist status, patient age, sex, race, ethnicity, number of comorbidities, antiplatelet therapy used at baseline, and baseline use of H2 receptor antagonists.||13.05|2.54|<0.001
72521899|NCT05563714|144572978|SUPERIORITY||Odds Ratio (OR)|29.3|||<|0.001|TWO_SIDED|95.0|6.07|141.49|||generalized linear mixed effects model||Adjusted OR (base model)|Adjusted OR (base model), 95% CI - Included clinician proceduralist vs non-proceduralist status as a co-variate.||141.49|6.07|<0.001
72521900|NCT05563714|144572978|SUPERIORITY||Odds Ratio (OR)|43.6|||<|0.001|TWO_SIDED|95.0|6.56|289.88|||generalized linear mixed effects model||Adjusted OR (expanded model)|Adjusted OR (expanded model), 95% CI - Adjusted for clinician proceduralist vs non-proceduralist status, patient age, sex, race, ethnicity, number of comorbidities, antiplatelet therapy used at baseline, and baseline use of H2 receptor antagonists.||289.88|6.56|<0.001
72521901|NCT05563714|144572979|SUPERIORITY|Adjusted OR, 95% CI (base model) - Included clinician proceduralist vs non-proceduralist status as a co-variate.|Odds Ratio, log|19.86|||<|0.001|TWO_SIDED|95.0|10.63|29.09|||generalized linear mixed effects model|||We used generalized linear mixed effects modeling (logit link) to estimate the odds of medication optimization at week 7-10. This model included fixed effects for CNNF (vs. usual care), target provider specialty and size, and a random effect for clinician to account for the clustering of patients. We report the log odds ratios with corresponding confidence intervals for the main effect. The main effect was tested at a two-sided 5% significance level.||29.09|10.63|<0.001
72521902|NCT01815580|144572986|OTHER||||||>|0.75|||||||Chi-squared|||||||>0.75
72570168|NCT02504671|144670135|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-4.8|15.6|||||Week 28, ACR50. Difference to Placebo for Week 28 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||15.6|-4.8|
72369332|NCT00611026|144248572|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.6|STANDARD_ERROR_OF_MEAN|1.1|<|0.0001|TWO_SIDED|95.0|3.4|7.9|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.|Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.|Treatment Difference Fesoterodine vs placebo: HRQL scale score total.||7.9|3.4|<0.0001
72521903|NCT01815580|144572987|OTHER|||||||0.14|||||||t-test, 2 sided|||||||0.14
72521904|NCT01815580|144572988|OTHER||||||>|0.3|||||||Chi-squared|||||||>0.3
72521905|NCT01815580|144572989|OTHER||||||>|0.12|||||||Chi-squared|||||||>0.12
72521906|NCT01815580|144572990|OTHER||||||>|0.22|||||||Chi-squared|||||||>0.22
72521907|NCT02228564|144572991|NON_INFERIORITY|"The sample size calculation assumes the following:~The LIFESTREAM™ Covered Stent composite event rate is estimated at 10.5% The Performance Goal is set at 19.5% The Type 1 error, α = 0.05 (one-sided). The Type 2 error, β = 0.10 (Power = 1 - β = 90%). The calculated sample size is 139 subjects to be followed through the 9-month follow-up visit (using nQuery 7.0). To accommodate 10% censoring, the sample size is increased to 154."|||||<|0.0325|||||||Exact binomial test|||"H0: The proportion of subjects in the LifeStream™ Covered Stent group (PBBX) with events in the primary endpoint is greater than or equal to that of the PG of 19.5%.~H1: The proportion of subjects in the LifeStream™ Covered Stent group (PBBX) with events in the primary endpoint is less than that of the PG of 19.5%."||||<0.0325
72521908|NCT01711658|144573011|SUPERIORITY||Hazard Ratio (HR)|0.91||||0.3436|TWO_SIDED|95.0|0.56|1.46|||Log Rank|One-sided significance level = 0.1803|Reference level = IMRT + cisplatin + placebo|Hazard ratio (lapatinib/placebo) set at 0.65 (35% reduction), 1-sided alpha 0.20 (final test at 0.1803 accounting for 1 interim analysis), logrank test, 80% power, 69 events in 128 randomized (142 total enrolled) patients required. Final analysis at 67 (of 69) events drops power to 79%.||1.46|0.56|0.3436
72521909|NCT01711658|144573012|SUPERIORITY||Hazard Ratio (HR)|1.06||||0.5836|TWO_SIDED|95.0|0.61|1.86|||Log Rank|One-sided significance level = 0.05|Reference level = IMRT + cisplatin + placebo|||1.86|0.61|0.5836
72521910|NCT01711658|144573013|SUPERIORITY||Hazard Ratio (HR)|0.64||||0.1743|TWO_SIDED|95.0|0.25|1.65|||Log Rank|One-sided significance level = 0.05|Reference level = IMRT + cisplatin + placebo|||1.65|0.25|0.1743
72521911|NCT01711658|144573014|SUPERIORITY|||||||0.7989|||||||Fisher Exact|Two-sided significance level = 0.05||||||0.7989
72521912|NCT01711658|144573015|SUPERIORITY|||||||0.3728||||||IMRT|Fisher Exact|Two-sided significance level = 0.05||||||0.3728
72521913|NCT01711658|144573015|OTHER|||||||0.7781||||||Cisplatin|Fisher Exact|Two-sided significance level = 0.05||||||0.7781
72521914|NCT01711658|144573015|OTHER|||||||0.8||||||Pre-IMRT lapatinib/placebo|Fisher Exact|Two-sided significance level = 0.05||||||0.8000
72521915|NCT01711658|144573015|OTHER|||||||0.6459||||||Concurrent lapatinib/placebo|Fisher Exact|Two-sided significance level = 0.05||||||0.6459
72521916|NCT01711658|144573015|OTHER|||||||0.4792||||||Maintenance lapatinib/placebo|Fisher Exact|Two-sided significance level = 0.05||||||0.4792
72521917|NCT01711658|144573016|SUPERIORITY||Hazard Ratio (HR)|1.15||||0.6735|TWO_SIDED|95.0|0.62|2.17|||Log Rank|One-sided significance level = 0.05|Reference level = IMRT + cisplatin + placebo|||2.17|0.62|0.6735
72521918|NCT03061812|144573032|SUPERIORITY||Hazard Ratio (HR)|1.46||||0.0051|TWO_SIDED|95.0|1.17|1.82|||Log Rank|Two-sided p-value stratified by the randomization stratification factors.|Calculated using a Cox proportional hazards regression model, with treatment and randomization stratification factors as covariates.|||1.82|1.17|0.0051
72521919|NCT03061812|144573033|SUPERIORITY||Hazard Ratio (HR)|1.51|||<|0.0001|TWO_SIDED|95.0|1.22|1.87|||Log Rank|Two-sided p-value stratified by the randomization stratification factors.|Calculated using a Cox proportional hazards regression model, with treatment and randomization stratification factors as covariates.|||1.87|1.22|< 0.0001
72570169|NCT02504671|144670135|OTHER||Difference|13.5|||||TWO_SIDED|95.0|0.5|26.5|||||Week 28, ACR50. Difference to Placebo for Week 28 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||26.5|0.5|
72521920|NCT03061812|144573034|SUPERIORITY||LS Mean of Difference|-0.5|STANDARD_ERROR_OF_MEAN|2.62|||TWO_SIDED|95.0|-5.66|4.65||||||||4.65|-5.66|
72521921|NCT03061812|144573035|SUPERIORITY||Odds Ratio (OR)|0.68||||0.3352|TWO_SIDED|95.0|0.39|1.18|||Cochran-Mantel-Haenszel|Stratified by the randomization stratification factors.||||1.18|0.39|0.3352
72521922|NCT03061812|144573036|SUPERIORITY||Odds Ratio (OR)|0.73||||0.0358|TWO_SIDED|95.0|0.47|1.12|||Cochran-Mantel-Haenszel|Stratified by the randomization stratification factors.||||1.12|0.47|0.0358
72521923|NCT01731990|144573049|SUPERIORITY_OR_OTHER_LEGACY||Treatment effect for ratio to placebo|1.06||||0.284|TWO_SIDED|90.0|0.97|1.15|||Mixed Models Analysis|||||1.15|0.97|0.284
72521924|NCT01280812|144573053|SUPERIORITY||Median Difference (Net)|1100.0|STANDARD_DEVIATION|3000.0|||TWO_SIDED|95.0|||||Mixed Models Analysis|Two-sided P values less than .05 were considered statistically significant.||Intent to treat analysis||||
72521925|NCT02279160|144573137|SUPERIORITY||Multiple imputation|0.742||||0.022|TWO_SIDED|95.0|0.575|0.958|||ANCOVA|||||0.958|0.575|0.0220
72521926|NCT02279160|144573138|SUPERIORITY||Hodges-Lehmann estimate|0.0||||0.9002|TWO_SIDED|95.0|-28.0|30.0|||Stratified Wilcoxon|||||30.0|-28.0|0.9002
72521927|NCT03805971|144573196|SUPERIORITY|||||||0.0003|||||||Fisher Exact|||"The objective of the test is to assess if the pCLE feature full chia seed sign is found statistically more frequently in the benign pleura group than in the malignant pleural infiltrations group."||||0.0003
72521928|NCT03805971|144573196|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||"The objective is to assess if the abnormal tissular architecture is significantly more frequently found in the malignant pleural infiltrations group than in the benign pleura group."||||<0.0001
72521929|NCT03805971|144573196|SUPERIORITY|||||||0.0052|||||||Fisher Exact|||"The objective is to assess if the pCLE feature cellular shape homogeneity is found statistically more frequently in the benign pleura group than in the malignant pleural infiltrations group."||||0.0052
72406036|NCT00653224|144320382|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.57|||<|0.001||95.0|-0.86|-0.28||If the p-value of this estimated difference is lower than 5% the mean TOSS is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the Mean TOSS including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean TOSS over the total treatment period is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.28|-0.86|<0.001
72406037|NCT00653224|144320383|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.23|||<|0.001||95.0|-0.34|-0.13||If the p-value of this estimated difference is lower than 5% the sneezing mean score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the Sneezing Mean Score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The sneezing mean score over Week 1 is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.13|-0.34|<0.001
72406038|NCT00653224|144320384|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.22|||<|0.001||95.0|-0.34|-0.09||If the p-value of this estimated difference is lower than 5% the sneezing mean score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the Sneezing Mean Score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The sneezing mean score over week 2 is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.09|-0.34|<0.001
72406039|NCT00653224|144320385|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.23|||<|0.001||95.0|-0.33|-0.12||If the p-value of this estimated difference is lower than 5% the sneezing mean score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the Sneezing Mean Score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The sneezing mean score over the total treatment period is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.12|-0.33|<0.001
72406040|NCT00653224|144320386|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.21|||<|0.001||95.0|-0.32|-0.11||If the p-value of this estimated difference is lower than 5% the rhinorrhea mean score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the Rhinorrhea Mean Score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The rhinorrhea mean score over Week 1 is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.11|-0.32|<0.001
72406041|NCT00653224|144320387|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.17||||0.008||95.0|-0.3|-0.05||If the p-value of this estimated difference is lower than 5% the rhinorrhea mean score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the Rhinorrhea Mean Score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The rhinorrhea mean score over week 2 is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.05|-0.30|0.008
72406042|NCT00653224|144320388|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.19|||<|0.001||95.0|-0.3|-0.09||If the p-value of this estimated difference is lower than 5% the rhinorrhea mean score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the Rhinorrhea Mean Score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The rhinorrhea mean score over the total treatment period is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.09|-0.30|<0.001
72406043|NCT00653224|144320389|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.05||||0.384||95.0|-0.15|0.06||If the p-value of this estimated difference is lower than 5% the nasal congestion mean score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the Nasal Congestion Mean Score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The nasal congestion mean score over week 1 is not different from subjects treated with levocetirizine than subjects treated with placebo.'||0.06|-0.15|0.384
72406044|NCT00653224|144320390|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.12||||0.063||95.0|-0.24|0.01||If the p-value of this estimated difference is lower than 5% the nasal congestion mean score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the Nasal Congestion Mean Score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The nasal congestion mean score over week 2 is not different from subjects treated with levocetirizine than subjects treated with placebo.'||0.01|-0.24|0.063
72521930|NCT03805971|144573196|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||"The objective is to assess if dysplastic vessels are more frequently found in the malignant pleural infiltrations group than in the benign pleura group."||||<0.0001
72521931|NCT03012594|144573201|SUPERIORITY|||||||0.07|TWO_SIDED|95.0|||||t-test, 2 sided|||||||0.07
72521932|NCT01224106|144573260|SUPERIORITY||Effect Size|-0.044||||0.6744|TWO_SIDED|95.0|-0.248|0.161|||Mixed Models Analysis|||||0.161|-0.248|0.6744
72521933|NCT01224106|144573260|SUPERIORITY||Effect Size|-0.085||||0.4494|TWO_SIDED|95.0|-0.304|0.135|||Mixed Models Analysis|||||0.135|-0.304|0.4494
72521934|NCT01224106|144573262|SUPERIORITY||Effect Size|0.035||||0.7458|TWO_SIDED|95.0|-0.179|0.25|||Mixed Models Analysis|||||0.250|-0.179|0.7458
72521935|NCT01224106|144573262|SUPERIORITY||Effect Size|0.042||||0.723|TWO_SIDED|95.0|-0.191|0.275|||Mixed Models Analysis|||||0.275|-0.191|0.723
72521936|NCT01224106|144573266|SUPERIORITY||Effect Size|-0.191||||0.0825|TWO_SIDED|95.0|-0.407|0.025|||Mixed Models Analysis|||||0.025|-0.407|0.0825
72521937|NCT01224106|144573266|SUPERIORITY||Effect Size|0.043||||0.7171|TWO_SIDED|95.0|-0.19|0.276|||Mixed Models Analysis|||||0.276|-0.19|0.7171
72521938|NCT01224106|144573269|SUPERIORITY|||||||0.9734|||||||Mixed Models Analysis|||"Statistical analysis of the Abeta 1-42 CSF biomarker between Placebo (Parts 1 and 2) and Gantenerumab 105 mg (Parts 1 and 2) treatment arms at Week 104."||||0.9734
72521939|NCT01224106|144573269|SUPERIORITY|||||||0.0629|||||||Mixed Models Analysis|||"Statistical analysis of the Abeta 1-42 CSF biomarker between Placebo (Parts 1 and 2) and Gantenerumab 225 mg (Parts 1 and 2) treatment arms at Week 104."||||0.0629
72521940|NCT01224106|144573269|SUPERIORITY|||||||0.0084|||||||Mixed Models Analysis|||"Statistical analysis of the p-tau CSF biomarker between Placebo (Parts 1 and 2) and Gantenerumab 105 mg (Parts 1 and 2) treatment arms at Week 104."||||0.0084
72521941|NCT01224106|144573269|SUPERIORITY|||||||0.0003|||||||Mixed Models Analysis|||"Statistical analysis of the p-tau CSF biomarker between Placebo (Parts 1 and 2) and Gantenerumab 225 mg (Parts 1 and 2) treatment arms at Week 104."||||0.0003
72521942|NCT01224106|144573269|SUPERIORITY|||||||0.0903|||||||Mixed Models Analysis|||"Statistical analysis of the t-tau CSF biomarker between Placebo (Parts 1 and 2) and Gantenerumab 105 mg (Parts 1 and 2) treatment arms at Week 104."||||0.0903
72521943|NCT01224106|144573269|SUPERIORITY|||||||0.0434|||||||Mixed Models Analysis|||"Statistical analysis of the t-tau CSF biomarker between Placebo (Parts 1 and 2) and Gantenerumab 225 mg (Parts 1 and 2) treatment arms at Week 104."||||0.0434
72521944|NCT00446797|144573288|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|To conclude non inferiority, the lower bound of the 2-sided 95% confidence interval of the difference in change scores between the 2 treatment groups (nsNSAIDs - celecoxib) must be greater than -10 mm.|Mean Difference (Final Values)|3.39|STANDARD_ERROR_OF_MEAN|2.11||||95.0|-0.76|7.55|||ANCOVA|Terms for treatment, country (fixed), and the baseline pain VAS score|Direction: nsNSAIDs minus celecoxib|Least squares mean||7.55|-0.76|
72521945|NCT00446797|144573289|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.1|STANDARD_ERROR_OF_MEAN|2.02||||95.0|-0.89|7.08|||ANCOVA|Terms for treatment, country (fixed) and the baseline pain VAS score|Direction: nsNSAIDs minus celecoxib|Day 2 Least squares mean||7.08|-0.89|
72521946|NCT00446797|144573289|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.46|STANDARD_ERROR_OF_MEAN|2.04||||95.0|-0.55|7.48|||ANCOVA|Terms for treatment, country (fixed) and the baseline pain VAS score|Direction: nsNSAIDs minus celecoxib|Day 3 Least squares mean||7.48|-0.55|
72521947|NCT00446797|144573289|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.76|STANDARD_ERROR_OF_MEAN|1.86||||95.0|-0.91|6.42|||ANCOVA|Terms for treatment, country (fixed) and the baseline pain VAS score|Direction: nsNSAIDs minus celecoxib|Day 7 Least squares mean||6.42|-0.91|
72521948|NCT00446797|144573290|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1591||95.0||||Threshold for statistical significance: p value is less than or equal to 0.05|Regression, Logistic|Terms for treatment and the baseline pain VAS score||Day 2||||0.1591
72521949|NCT00446797|144573290|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3995||95.0||||Threshold for statistical significance: p value is less than or equal to 0.05|Regression, Logistic|Terms for treatment and the baseline pain VAS score||Day 3||||0.3995
72521950|NCT00446797|144573290|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6805||95.0||||Threshold for statistical significance: p value is less than or equal to 0.05|Regression, Logistic|Terms for treatment and the baseline pain VAS score||Day 7||||0.6805
72521951|NCT00446797|144573291|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2411||95.0||||Threshold for statistical significance: p value is less than or equal to 0.05|Cochran-Mantel-Haenszel|Controlled for country Test of row mean score differences based on modified ridits (standardizing the mid-rank)||Day 2||||0.2411
72570170|NCT02504671|144670135|OTHER||Difference|16.2|||||TWO_SIDED|95.0|2.6|29.9|||||Week 28, ACR50. Difference to Placebo for Week 28 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||29.9|2.6|
72521952|NCT00446797|144573291|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1163||95.0||||Threshold for statistical significance: p value is less than or equal to 0.05|Cochran-Mantel-Haenszel|Controlled for country Test of row mean score differences based on modified ridits (standardizing the mid-rank)||Day 3||||0.1163
72521953|NCT00446797|144573291|SUPERIORITY_OR_OTHER_LEGACY|||||||0.044||95.0||||Threshold for statistical significance: p value is less than or equal to 0.05|Cochran-Mantel-Haenszel|Controlled for country Test of row mean score differences based on modified ridits (standardizing the mid-rank)||Day 7||||0.0440
72521954|NCT00446797|144573292|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7223||95.0||||Threshold for statistical significance: p value is less than or equal to 0.05|Cochran-Mantel-Haenszel|"Controlled for country~Test of row mean score differences based on modified ridits (standardizing the mid-rank)"||Day 3||||0.7223
72521955|NCT00446797|144573292|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0541||95.0||||Threshold for statistical significance: p value is less than or equal to 0.05|Cochran-Mantel-Haenszel|"Controlled for country~Test of row mean score differences based on modified ridits (standardizing the mid-rank)"||Day 7||||0.0541
72521956|NCT00446797|144573293|SUPERIORITY_OR_OTHER_LEGACY|||||||0.29||95.0||||Threshold for statistical significance: p value is less than or equal to 0.05|Cochran-Mantel-Haenszel|"Controlled for country~Test of row mean score differences based on modified ridits (standardizing the mid-rank)"||Day 2||||0.2900
72521957|NCT00446797|144573293|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0157||95.0||||Threshold for statistical significance: p value is less than or equal to 0.05|Cochran-Mantel-Haenszel|"Controlled for country~Test of row mean score differences based on modified ridits (standardizing the mid-rank)"||Day 3||||0.0157
72521958|NCT00446797|144573293|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1206||95.0||||Threshold for statistical significance: p value is less than or equal to 0.05|Cochran-Mantel-Haenszel|"Controlled for country~Test of row mean score differences based on modified ridits (standardizing the mid-rank)"||Day 7||||0.1206
72521959|NCT00446797|144573294|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0846||95.0||||Threshold for statistical significance: p value is less than or equal to 0.05|Cochran-Mantel-Haenszel|Controlled for country Test of row mean score differences based on modified ridits (standardizing the mid-rank)||Day 2||||0.0846
72521960|NCT00446797|144573294|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3041||95.0||||Threshold for statistical significance: p value is less than or equal to 0.05|Cochran-Mantel-Haenszel|Controlled for country Test of row mean score differences based on modified ridits (standardizing the mid-rank)||Day 3||||0.3041
72521961|NCT00446797|144573294|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1216||95.0||||Threshold for statistical significance: p value is less than or equal to 0.05|Cochran-Mantel-Haenszel|Controlled for country Test of row mean score differences based on modified ridits (standardizing the mid-rank)||Day 7||||0.1216
72570171|NCT02504671|144670135|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-4.8|15.6|||||Week 28, ACR70. Difference to Placebo for Week 28 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||15.6|-4.8|
72521962|NCT00446797|144573295|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.14|STANDARD_ERROR_OF_MEAN|0.24||0.395||95.0|-0.33|0.62||Overall p-value|ANCOVA|Terms for treatment and country|Direction: nsNSAIDs minus celecoxib|Day 2 Least squares mean||0.62|-0.33|0.395
72521963|NCT00446797|144573295|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.61|STANDARD_ERROR_OF_MEAN|0.22||0.004||95.0|0.18|1.04||Overall p value|ANCOVA|Terms for treatment and country|Direction: nsNSAIDs minus celecoxib|Day 3 Least squares mean||1.04|0.18|0.004
72521964|NCT00446797|144573295|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.35|STANDARD_ERROR_OF_MEAN|0.22||0.122||95.0|-0.08|0.77||Overall p value|ANCOVA|Terms for treatment and country|Direction: nsNSAIDs minus celecoxib|Day 7 Least squares mean||0.77|-0.08|0.122
72521965|NCT00446797|144573296|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.09|STANDARD_ERROR_OF_MEAN|0.21||0.604||95.0|-0.32|0.49||Overall p value|ANCOVA|Terms for treatment and country|Direction: nsNSAIDs minus celecoxib|Day 2 Least squares mean||0.49|-0.32|0.604
72521966|NCT00446797|144573296|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.28|STANDARD_DEVIATION|0.18||0.124||95.0|-0.07|0.63||Overall p value|ANCOVA|Terms for treatment and country|Direction: nsNSAIDs minus celecoxib|Day 3 Least squares mean||0.63|-0.07|0.124
72521967|NCT00446797|144573296|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.32|STANDARD_ERROR_OF_MEAN|0.15||0.062||95.0|0.03|0.61||Overall p value|ANCOVA|Terms for treatment and country|Direction: nsNSAIDs minus celecoxib|Day 7 Least squares mean||0.61|0.03|0.062
72521968|NCT00446797|144573297|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.21||0.705||95.0|-0.36|0.47||Overall p value|ANCOVA|Terms for treatment and country|Direction: nsNSAIDs minus celecoxib|Day 2 Least squares mean||0.47|-0.36|0.705
72521969|NCT00446797|144573297|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.36|STANDARD_ERROR_OF_MEAN|0.19||0.064||95.0|-0.01|0.73||Overall p value|ANCOVA|Terms for treatment and country|Direction: nsNSAIDs minus celecoxib|Day 3 Least squares mean||0.73|-0.01|0.064
72521970|NCT00446797|144573297|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.34|STANDARD_ERROR_OF_MEAN|0.17||0.074||95.0|-0.01|0.68||Overall p value|ANCOVA|Terms for treatment and country|Direction: nsNSAIDs minus celecoxib|Day 7 Least squares mean||0.68|-0.01|0.074
72570172|NCT02504671|144670135|OTHER||Difference|10.8|||||TWO_SIDED|95.0|-1.4|23.0|||||Week 28, ACR70. Difference to Placebo for Week 28 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||23.0|-1.4|
72521971|NCT00446797|144573298|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.58|STANDARD_ERROR_OF_MEAN|0.24||0.017||95.0|0.11|1.05||Overall p value|ANCOVA|Terms for treatment and country|Direction: nsNSAIDs minus celecoxib|Day 2 Least squares mean||1.05|0.11|0.017
72521972|NCT00446797|144573298|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.34|STANDARD_ERROR_OF_MEAN|0.2||0.108||95.0|-0.05|0.74||Overall p value|ANCOVA|Terms for treatment and country|Direction: nsNSAIDs minus celecoxib|Day 3 Least squares mean||0.74|-0.05|0.108
72521973|NCT00446797|144573298|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.32|STANDARD_ERROR_OF_MEAN|0.17||0.117||95.0|-0.01|0.66||Overall p value|ANCOVA|Terms for treatment and country|Direction: nsNSAIDs minus celecoxib|Day 7 Least squares mean||0.66|-0.01|0.117
72521974|NCT00446797|144573299|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.21|STANDARD_ERROR_OF_MEAN|0.2||0.229||95.0|-0.17|0.6||Overall p value|ANCOVA|Terms for treatment and country|Direction: nsNSAIDs minus celecoxib|Day 2 Least squares mean||0.60|-0.17|0.229
72521975|NCT00446797|144573299|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.4|STANDARD_ERROR_OF_MEAN|0.18||0.027||95.0|0.05|0.75||Overall p value|ANCOVA|Terms for treatment and country|Direction: nsNSAIDs minus celecoxib|Day 3 Least squares mean||0.75|0.05|0.027
72521976|NCT00446797|144573299|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.33|STANDARD_ERROR_OF_MEAN|0.16||0.07||95.0|0.01|0.65||Overall p value|ANCOVA|Terms for treatment and country|Direction: nsNSAIDs minus celecoxib|Day 7 Least squares mean||0.65|0.01|0.070
72521977|NCT00446797|144573300|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.3||0.954||95.0|-0.64|0.53||Overall p value|ANCOVA|Terms for treatment and country|Direction: nsNSAIDs minus celecoxib|Day 2 Least squares mean||0.53|-0.64|0.954
72521978|NCT00446797|144573300|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.41|STANDARD_ERROR_OF_MEAN|0.31||0.172||95.0|-0.19|1.02||Overall p value|ANCOVA|Terms for treatment and country|Direction: nsNSAIDs minus celecoxib|Day 3 Least squares mean||1.02|-0.19|0.172
72521979|NCT00446797|144573300|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.16|STANDARD_ERROR_OF_MEAN|0.24||0.541||95.0|-0.3|0.62||Overall p value|ANCOVA|Terms for treatment and country|Direction: nsNSAIDs minus celecoxib|Day 7 Least squares mean||0.62|-0.30|0.541
72521980|NCT00446797|144573301|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.08|STANDARD_ERROR_OF_MEAN|0.34||0.924||95.0|-0.75|0.58||Overall p value|ANCOVA|Terms for treatment and country|Direction: nsNSAIDs minus celecoxib|Day 2 Least squares mean||0.58|-0.75|0.924
72521981|NCT00446797|144573301|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.06|STANDARD_ERROR_OF_MEAN|0.29||0.898||95.0|-0.62|0.51||Overall p value|ANCOVA|Terms for treatment and country|Direction: nsNSAIDs minus celecoxib|Day 3 Least squares mean||0.51|-0.62|0.898
72570173|NCT02504671|144670135|OTHER||Difference|10.8|||||TWO_SIDED|95.0|-1.4|23.0|||||Week 28, ACR70. Difference to Placebo for Week 28 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||23.0|-1.4|
72406045|NCT00653224|144320391|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.08||||0.124||95.0|-0.19|0.02||If the p-value of this estimated difference is lower than 5% the nasal congestion mean score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the Nasal Congestion Mean Score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The nasal congestion mean score over the total treatment period is not different from subjects treated with levocetirizine than subjects treated with placebo.'||0.02|-0.19|0.124
72521982|NCT00446797|144573301|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.13|STANDARD_ERROR_OF_MEAN|0.24||0.655||95.0|-0.33|0.6||Overall p value|ANCOVA|Terms for treatment and country|Direction: nsNSAIDs minus celecoxib|Day 7 Least squares mean||0.60|-0.33|0.655
72521983|NCT00446797|144573302|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.31||0.929||95.0|-0.59|0.62||Overall p value|ANCOVA|Terms for treatment and country|Direction: nsNSAIDs minus celecoxib|Day 2 Least squares mean||0.62|-0.59|0.929
72521984|NCT00446797|144573302|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.11|STANDARD_ERROR_OF_MEAN|0.3||0.712||95.0|-0.5|0.71||Overall p value|ANCOVA|Terms for treatment and country|Direction: nsNSAIDs minus celecoxib|Day 3 Least squares mean||0.71|-0.50|0.712
72521985|NCT00446797|144573302|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.04|STANDARD_ERROR_OF_MEAN|0.24||0.993||95.0|-0.44|0.51||Overall p value|ANCOVA|Terms for treatment and country|Direction: nsNSAIDs minus celecoxib|Day 7 Least squares mean||0.51|-0.44|0.993
72521986|NCT00446797|144573303|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.11|STANDARD_DEVIATION|0.32||0.779||95.0|-0.53|0.75||Overall p value|ANCOVA|Terms for treatment and country|Direction: nsNSAIDs minus celecoxib|Day 2 Least squares mean||0.75|-0.53|0.779
72521987|NCT00446797|144573303|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.34||0.972||95.0|-0.69|0.65||Overall p value|ANCOVA|Terms for treatment and country|Direction: nsNSAIDs minus celecoxib|Day 3 Least squares mean||0.65|-0.69|0.972
72521988|NCT00446797|144573303|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.07|STANDARD_ERROR_OF_MEAN|0.27||0.844||95.0|-0.47|0.61||Overall p value|ANCOVA|Terms for treatment and country|Direction: nsNSAIDs minus celecoxib|Day 7 Least squares mean||0.61|-0.47|0.844
72521989|NCT00446797|144573304|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.31||0.944||95.0|-0.63|0.6||Overall p value|ANCOVA|Terms for treatment and country|Direction: nsNSAIDs minus celecoxib|Day 2 Least squares mean||0.60|-0.63|0.944
72521990|NCT00446797|144573304|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.12|STANDARD_ERROR_OF_MEAN|0.26||0.654||95.0|-0.62|0.38||Overall p value|ANCOVA|Terms for treatment and country|Direction: nsNSAIDs minus celecoxib|Day 3 Least squares mean||0.38|-0.62|0.654
72521991|NCT00446797|144573304|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.19||0.952||95.0|-0.36|0.39||Overall p value|ANCOVA|Terms for treatment and country|Direction: nsNSAIDs minus celecoxib|Day 7 Least squares mean||0.39|-0.36|0.952
72521992|NCT00446797|144573305|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.03|STANDARD_ERROR_OF_MEAN|0.31||0.842||95.0|-0.65|0.59||Overall p value|ANCOVA|Terms for treatment and country|Direction: nsNSAIDs minus celecoxib|Day 2 Least squares mean||0.59|-0.65|0.842
72521993|NCT00446797|144573305|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.04|STANDARD_ERROR_OF_MEAN|0.27||0.828||95.0|-0.57|0.49||Overall p value|ANCOVA|Terms for treatment and country|Direction: nsNSAIDs minus celecoxib|Day 3 Least squares mean||0.49|-0.57|0.828
72521994|NCT00446797|144573305|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.12|STANDARD_ERROR_OF_MEAN|0.21||0.542||95.0|-0.3|0.53||Overall p value|ANCOVA|Terms for treatment and country|Direction: nsNSAIDs minus celecoxib|Day 7 Least squares mean||0.53|-0.30|0.542
72521995|NCT00446797|144573306|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.25|STANDARD_ERROR_OF_MEAN|0.34||0.404||95.0|-0.92|0.42||Overall p value|ANCOVA|Terms for treatment and country|Direction: nsNSAIDs minus celecoxib|Day 2 Least squares mean||0.42|-0.92|0.404
72521996|NCT00446797|144573306|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.28||0.816||95.0|-0.53|0.58||Overall p value|ANCOVA|Terms for treatment and country|Direction: nsNSAIDs minus celecoxib|Day 3 Least squares mean||0.58|-0.53|0.816
72521997|NCT00446797|144573306|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.07|STANDARD_ERROR_OF_MEAN|0.23||0.837||95.0|-0.37|0.52||Overall p value|ANCOVA|Terms for treatment and country|Direction: nsNSAIDs minus celecoxib|Day 7 Least squares mean||0.52|-0.37|0.837
72521998|NCT00446797|144573307|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.04|STANDARD_ERROR_OF_MEAN|0.25||0.887||95.0|-0.54|0.45||Overall p value|ANCOVA|Terms for treatment and country|Direction: nsNSAIDs minus celecoxib|Day 2 Least squares mean||0.45|-0.54|0.887
72521999|NCT00446797|144573307|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.04|STANDARD_ERROR_OF_MEAN|0.24||0.889||95.0|-0.43|0.51||Overall p value|ANCOVA|Terms for treatment and country|Direction: nsNSAIDs minus celecoxib|Day 3 Least squares mean||0.51|-0.43|0.889
72522000|NCT00446797|144573307|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.09|STANDARD_ERROR_OF_MEAN|0.2||0.738||95.0|-0.3|0.47||Overall p value|ANCOVA|Terms for treatment and country|Direction: nsNSAIDs minus celecoxib|Day 7 Least squares mean||0.47|-0.30|0.738
72522001|NCT02498392|144573314|SUPERIORITY||Difference of Least Square (LS) Means|-0.2|STANDARD_ERROR_OF_MEAN|1.04|=|0.416|TWO_SIDED|60.0|-1.1|0.66|||Mixed-effects Model for Repeated Measure|||||0.66|-1.10|= 0.416
72522002|NCT02498392|144573315|SUPERIORITY||Difference of Least Square (LS) Means|0.3|STANDARD_ERROR_OF_MEAN|0.88|=|0.647|TWO_SIDED|60.0|-0.41|1.07||1-sided|Mixed-effects Model for Repeated Measure|||||1.07|-0.41|= 0.647
72522003|NCT03097133|144573339|SUPERIORITY||Difference of Least Square Means|-3.9|STANDARD_ERROR_OF_MEAN|1.39||0.006|TWO_SIDED|95.0|-6.6|-1.11|||ANCOVA|||||-1.11|-6.60|0.006
72522004|NCT04080752|144573363|SUPERIORITY||Least Square (LS) Mean Difference|-0.61|STANDARD_ERROR_OF_MEAN|0.897||0.2494|TWO_SIDED|80.0|-1.76|0.55|||Mixed Model for Repeated Measures (MMRM)|||||0.55|-1.76|0.2494
72522005|NCT03326583|144573378|SUPERIORITY|||||||0.05|||||||Fisher Exact|||||||.05
72522006|NCT03326583|144573379|SUPERIORITY|||||||0.05|||||||Mixed Models Analysis|||||||.05
72522007|NCT03326583|144573380|SUPERIORITY|||||||0.05|||||||Mixed Models Analysis|||||||.05
72522008|NCT03326583|144573381|SUPERIORITY|||||||0.05|||||||Mixed Models Analysis|||||||.05
72522009|NCT01641081|144573492|SUPERIORITY_OR_OTHER||Least squares mean difference|0.2644|STANDARD_ERROR_OF_MEAN|0.0148|<|0.0001|TWO_SIDED|95.0|0.2353|0.2934|||Mixed Models Analysis|Treatment and period as fixed effects, and baseline FEV1 values at each period as a covariate||||0.2934|0.2353|<0.0001
72522010|NCT01641081|144573492|SUPERIORITY_OR_OTHER||Least squares mean difference|0.2524|STANDARD_ERROR_OF_MEAN|0.0156|<|0.0001|TWO_SIDED|95.0|0.2218|0.283|||Mixed Models Analysis|Treatment and period as fixed effects, and baseline FEV1 values at each period as a covariate||||0.2830|0.2218|<0.0001
72522011|NCT01641081|144573492|SUPERIORITY_OR_OTHER||Least squares mean difference|0.2242|STANDARD_ERROR_OF_MEAN|0.0153|<|0.0001|TWO_SIDED|95.0|0.1941|0.2544|||Mixed Models Analysis|Treatment and period as fixed effects, and baseline FEV1 values at each period as a covariate||||0.2544|0.1941|<0.0001
72522012|NCT01641081|144573492|SUPERIORITY_OR_OTHER||Least squares mean difference|0.2174|STANDARD_ERROR_OF_MEAN|0.0146|<|0.0001|TWO_SIDED|95.0|0.1887|0.2461|||Mixed Models Analysis|Treatment and period as fixed effects, and baseline FEV1 values at each period as a covariate||||0.2461|0.1887|<0.0001
72522013|NCT01095666|144573494|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.59|STANDARD_ERROR_OF_MEAN|0.0869|<|0.0001|TWO_SIDED|95.0|-0.76|-0.42||Primary endpoints were tested at alpha=0.027 applying Dunnett's adjustment.|ANCOVA|||||-0.42|-0.76|<0.0001
72522014|NCT01095666|144573494|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.62|STANDARD_ERROR_OF_MEAN|0.0865|<|0.0001|TWO_SIDED|95.0|-0.79|-0.45||Primary endpoints were tested at alpha=0.027 applying Dunnett's adjustment.|ANCOVA|||||-0.45|-0.79|<0.0001
72522015|NCT01095666|144573495|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-22.1|STANDARD_ERROR_OF_MEAN|3.299|<|0.0001|TWO_SIDED|95.0|-28.6|-15.6||Secondary endpoints were tested following a sequential testing procedure at alpha=0.05.|ANCOVA|||||-15.6|-28.6|<0.0001
72522016|NCT01095666|144573495|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-27.1|STANDARD_ERROR_OF_MEAN|3.271|<|0.0001|TWO_SIDED|95.0|-33.5|-20.7||Secondary endpoints were tested following a sequential testing procedure at alpha=0.05.|ANCOVA|||||-20.7|-33.5|<0.0001
72522017|NCT01095666|144573496|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-42.3|STANDARD_ERROR_OF_MEAN|5.8758|<|0.0001|TWO_SIDED|95.0|-53.84|-30.73||Secondary endpoints were tested following a sequential testing procedure at alpha=0.05.|ANCOVA|||||-30.73|-53.84|<0.0001
72522018|NCT01095666|144573496|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-49.1|STANDARD_ERROR_OF_MEAN|5.7921|<|0.0001|TWO_SIDED|95.0|-60.53|-37.74||Secondary endpoints were tested following a sequential testing procedure at alpha=0.05.|ANCOVA|||||-37.74|-60.53|<0.0001
72522019|NCT01095666|144573497|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.1|STANDARD_ERROR_OF_MEAN|0.2765|<|0.0001|TWO_SIDED|95.0|-1.65|-0.56||Secondary endpoints were tested following a sequential testing procedure at alpha=0.05.|ANCOVA|||||-0.56|-1.65|<0.0001
72522020|NCT01095666|144573497|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.82|STANDARD_ERROR_OF_MEAN|0.2747|<|0.0001|TWO_SIDED|95.0|-2.36|-1.28||Secondary endpoints were tested following a sequential testing procedure at alpha=0.05.|ANCOVA|||||-1.28|-2.36|<0.0001
72406046|NCT00653224|144320392|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.17||||0.002||95.0|-0.28|-0.06||If the p-value of this estimated difference is lower than 5% the nasal pruritus mean score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the Nasal Pruritus Mean Score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The nasal pruritus mean score over week 1 is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.06|-0.28|0.002
72522021|NCT01095666|144573498|SUPERIORITY_OR_OTHER||Difference in percentage|15.4|STANDARD_ERROR_OF_MEAN|4.702||0.001|TWO_SIDED|95.0|6.2|24.7||Secondary endpoints were tested following a sequential testing procedure at alpha=0.05.|Modified logistic regression|Modified logistic regression model, adjusted for baseline HbA1c||||24.7|6.2|0.0010
72522022|NCT01095666|144573498|SUPERIORITY_OR_OTHER||Difference in percentage|15.5|STANDARD_ERROR_OF_MEAN|4.594||0.0007|TWO_SIDED|95.0|6.5|24.5||Secondary endpoints were tested following a sequential testing procedure at alpha=0.05.|Modified logistic regression|Modified logistic regression model, adjusted for baseline HbA1c||||24.5|6.5|0.0007
72522023|NCT03011775|144573507|SUPERIORITY||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|The threshold for statistical significance was P value of .05||||||<0.05
72522024|NCT03011775|144573508|SUPERIORITY||||||>|0.05|||||||Chi-squared|||||||>0.05
72522025|NCT03011775|144573510|SUPERIORITY||||||>|0.05|||||||Chi-squared|||||||>0.05
72522026|NCT03011775|144573511|SUPERIORITY||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
72522027|NCT03011775|144573513|SUPERIORITY||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
72522028|NCT03011775|144573514|SUPERIORITY||||||<|0.05|||||||Chi-squared|||||||<0.05
72522029|NCT03011775|144573515|SUPERIORITY||||||=|0.3|||||||Wilcoxon (Mann-Whitney)|||||||=0.3
72522030|NCT00588380|144573516|SUPERIORITY_OR_OTHER|||||||0.11||95.0|||||Kruskal-Wallis|||Using the Kruskal-Wallis test (general allelic model), we assessed univariate associations of rs6923761 genotype with Phi Total in the presence of either glucose alone, glucose and 0.75 pmol/kg/min GLP-1 or glucose and 1.5 pmol/kg/min GLP-1 If the p-value for the overall univariate test of association was \<0.1, then the associations for specific genotype pairs (e.g.: 1,1 vs. 1,2 or 2,2 vs. 1,1) were also examined using a Mann-Whitney Rank Sum test.||||0.11
72522031|NCT00588380|144573517|SUPERIORITY_OR_OTHER|||||||0.09||95.0|||||Kruskal-Wallis|||All data are presented as means ± SEM. Using the Kruskal-Wallis test (general allelic model), we assessed univariate associations of genotype with ΦTotal||||0.09
72522032|NCT01451398|144573521|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|||<|0.0001|TWO_SIDED|95.0|-0.57|-0.23|||Mixed Models Analysis|Change in HbA1c = Baseline HbA1c + Region + Pooled OAD Strata + Visit + Treatment + (Treatment\*Visit), using AR(1) variance/covariance structure.||||-0.23|-0.57|<0.0001
72522033|NCT01451398|144573522|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.726||||0.0005|TWO_SIDED|95.0|1.55|4.8|||Regression, Logistic|Model: Treatment + Pooled OAD Stratum + Region + Baseline HbA1c||||4.80|1.55|0.0005
72406047|NCT00653224|144320393|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.15||||0.016||95.0|-0.28|-0.03||If the p-value of this estimated difference is lower than 5% the nasal pruritus mean score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the Nasal Pruritus Mean Score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The nasal pruritus mean score over week 2 is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.03|-0.28|0.016
72406048|NCT00653224|144320394|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.16||||0.003||95.0|-0.27|-0.06||If the p-value of this estimated difference is lower than 5% the nasal pruritus mean score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the Nasal Pruritus Mean Score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The nasal pruritus mean score over the total treatment period is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.06|-0.27|0.003
72406049|NCT00653224|144320395|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.09||||0.088||95.0|-0.2|0.01||If the p-value of this estimated difference is lower than 5% the post-nasal drip mean score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the Post-Nasal Drip Mean Score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The post-nasal drip mean score over week 1 is not different from subjects treated with levocetirizine than subjects treated with placebo.'||0.01|-0.20|0.088
72522034|NCT01451398|144573523|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.361||||0.0021|TWO_SIDED|95.0|1.7|11.17|||Regression, Logistic|Model: Treatment + Pooled OAD Stratum + Region + Baseline HbA1c||||11.17|1.70|0.0021
72522035|NCT01451398|144573524|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-7.42|STANDARD_ERROR_OF_MEAN|5.4||0.1698|TWO_SIDED|95.0|-18.03|3.18|||Mixed Models Analysis|"Model: FPG = Baseline FPG + Region + Pooled OAD Stratum + Visit + Treatment + (Treatment \* Visit)~Variance/Covariance Matrix is Autoregression 1"||||3.18|-18.03|0.1698
72522036|NCT01451398|144573527|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.09|STANDARD_DEVIATION|0.018|||TWO_SIDED|95.0|-0.12|-0.05|||Mixed Models Analysis|FEV1 = Baseline FEV1 + Age + Gender + Race + Height + Visit + Treatment + (Treatment\*Visit)||||-0.05|-0.12|
72522037|NCT01451398|144573530|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Negative binomial regression|Model: Treatment + Region + OAD Stratum + Exposure Time||||||<0.0001
72522038|NCT01451398|144573531|SUPERIORITY_OR_OTHER|||||||0.2024|||||||Negative Binomial Regression|Model: Treatment + Region + OAD Stratum + Exposure Time||||||0.2024
72522039|NCT01451398|144573534|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.62|STANDARD_ERROR_OF_MEAN|0.365|<|0.0001|TWO_SIDED|95.0|0.9|2.34|||ANCOVA||Model: Baseline Weight + Change in HbA1c at Week 24 + Region + OAD Stratum + Treatment|||2.34|0.90|<0.0001
72522040|NCT01000025|144573539|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.0||||0.506|TWO_SIDED|95.0|0.83|1.21||Stratified by stratification factors at randomization except study center, but included K-Ras mutation status.1-sied p-value.|Log Rank|Stratified by stratification factors at randomization except study center, but included K-Ras mutation status.||The trial was designed to detect a 25% deduction in risk of death with PF-804 with 90% power using a 1-sided 2.5% level significance test. The sample size was estimated as 720 patients.||1.21|0.83|0.506
72522041|NCT01000025|144573540|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.79||||0.043|TWO_SIDED|95.0|0.61|1.03||1-sided p-value|Log Rank|Stratified by stratification factors at randomization except study center.||||1.03|0.61|0.043
72522042|NCT01000025|144573541|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.98||||0.46|TWO_SIDED|95.0|0.67|1.44||1-sided pvalue|Log Rank|||||1.44|0.67|0.46
72522043|NCT01000025|144573542|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.66|||<|0.0001|TWO_SIDED|95.0|0.55|0.79|||Log Rank|Stratified by stratification factors at randomization except study center, but included K-Ras mutation status.||||0.79|0.55|< 0.0001
72522044|NCT01000025|144573543|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|6.11||||0.001|TWO_SIDED|95.0|1.84|20.3|||Cochran-Mantel-Haenszel|||||20.3|1.84|0.001
72522045|NCT02738580|144573551|SUPERIORITY||Mean Difference (Final Values)|0.29|STANDARD_DEVIATION|0.26|<|0.05|TWO_SIDED|||||The proportion of patients with elevated Progesterone on last day of stimulation(\>1.5 ng/mL) was compared between both groups using the Chi-square test.|t-test, 2 sided|||||||<0.05
72522046|NCT02738580|144573552|SUPERIORITY||||||<|0.49|||||||t-test, 1 sided|||||||<0.49
72522047|NCT01324687|144573583|SUPERIORITY_OR_OTHER||Rate ratio|0.8387||||0.017|TWO_SIDED|95.0|0.7261|0.9689|||GEE / Poisson regression models|||Rate ratio of ED use rate of the intervention group as compared to the control group.||0.9689|0.7261|0.017
72522048|NCT01610206|144573621|EQUIVALENCE|To estimate the progression-free survival hazard ratio of the combination of weekly gemcitabine and pazopanib compared to weekly gemcitabine alone in patients with persistent or recurrent ovarian, fallopian tube, or primary peritoneal cancer.|Hazard Ratio (HR)|0.81||||0.019|TWO_SIDED|95.0|0.61|1.07|||non-parametric weighted Tarone-Ware test|||||1.07|0.61|0.019
72522049|NCT00166517|144573623|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was assessed versus a constant, 85%, based on historical data.||||||0.003||95.0||||p ≥.85, where p is the proportion of subjects who achieved ≥3-fold rise from baseline in the group that received RotaTeq®|Exact test of proportion|Exact test of proportion, based on binomial distribution||||||0.003
72522050|NCT02917629|144573669|SUPERIORITY||Mean Difference (Final Values)|1.0011|STANDARD_DEVIATION|0.024||0.031|TWO_SIDED||||||Benjamini and Hochberg|||ENSG00000229822 baseline and post exposure||||0.031
72522051|NCT02917629|144573669|SUPERIORITY||Mean Difference (Final Values)|-1.0217|STANDARD_DEVIATION|0.0257||0.031|TWO_SIDED||||||Benjamini and Hochberg|||ENSG00000230585 baseline and post exposure||||0.031
72522052|NCT02917629|144573669|SUPERIORITY||Mean Difference (Final Values)|-1.0098|STANDARD_DEVIATION|0.005|<|0.001|TWO_SIDED||||||Benjamini and Hochberg|||ENSG00000249245 baseline and post exposure||||<0.001
72406050|NCT00653224|144320396|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.117||95.0|-0.23|0.03||If the p-value of this estimated difference is lower than 5% the post-nasal drip mean score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the Post-Nasal Drip Mean Score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The post-nasal drip mean score over Week 2 is not different from subjects treated with levocetirizine than subjects treated with placebo.'||0.03|-0.23|0.117
72522053|NCT02917629|144573669|SUPERIORITY||Mean Difference (Final Values)|1.0007|STANDARD_DEVIATION|0.0063|<|0.001|TWO_SIDED||||||Benjamini and Hochberg|||ENSG00000261792 baseline and post exposure||||<0.001
72522054|NCT02917629|144573670|SUPERIORITY||Mean Difference (Final Values)|1.006|STANDARD_DEVIATION|0.006||0.002|TWO_SIDED||||||Benjamini and Hochberg|||ENSG00000234806 baseline and post exposure||||0.002
72522055|NCT02917629|144573671|SUPERIORITY||Mean Difference (Final Values)|1.0013|STANDARD_DEVIATION|0.0072||0.002|TWO_SIDED||||||Benjamini and Hochberg|||ENSG00000232479 baseline and post exposure||||0.002
72570174|NCT02504671|144670135|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-4.8|15.6|||||Week 32, ACR20. Difference to Placebo for Week 32 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||15.6|-4.8|
72570175|NCT02504671|144670135|OTHER||Difference|18.9|||||TWO_SIDED|95.0|4.7|33.2|||||Week 32, ACR20. Difference to Placebo for Week 32 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||33.2|4.7|
72570176|NCT02504671|144670135|OTHER||Difference|18.9|||||TWO_SIDED|95.0|4.7|33.2|||||Week 32, ACR20. Difference to Placebo for Week 32 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||33.2|4.7|
72522056|NCT02917629|144573671|SUPERIORITY||Mean Difference (Final Values)|1.0037|STANDARD_DEVIATION|0.0193||0.02|TWO_SIDED||||||Benjamini and Hochberg|||ENSG00000233163 baseline and post exposure||||0.020
72522057|NCT02917629|144573671|SUPERIORITY||Mean Difference (Final Values)|-1.0098|STANDARD_DEVIATION|0.005||0.001|TWO_SIDED||||||Benjamini and Hochberg|||ENSG00000249245 baseline and post-exposure||||0.001
72522058|NCT01042938|144573677|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7991|STANDARD_DEVIATION|0.7606||0.0077|TWO_SIDED|95.0|-1.3693|-0.2289|||Standard pooled variances t-test|||Hypothesis: The mean RDS for curcumin group is significantly different (i.e., lower) than mean RDS of placebo group at end of radiation treatment.||-0.2289|-1.3693|0.0077
72522059|NCT01042938|144573678|SUPERIORITY_OR_OTHER|||||||0.0022||95.0|||||Fisher Exact|||Hypothesis: The presence of moist desquamation significantly differed between the curcumin group and the placebo group.||||0.0022
72522060|NCT01042938|144573679|SUPERIORITY_OR_OTHER|||||||0.145||95.0|||||ANOVA|||Hypothesis: There is a significant difference in mean redness (i.e., mean a\* number value) between the curcumin and placebo groups.||||0.145
72522061|NCT01042938|144573680|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.685||||0.218|TWO_SIDED|95.0|-1.059|4.428|||ANCOVA|||Hypothesis: There is a significant difference in mean MPQ pain scores between the curcumin and placebo groups.||4.428|-1.059|0.218
72522062|NCT01042938|144573680|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.5||||0.152|TWO_SIDED|95.0|-0.6|3.6|||ANCOVA|||Hypothesis: There is a significant difference in mean sensory subscale pain scores between curcumin and placebo groups.||3.6|-0.6|0.152
72522063|NCT01042938|144573680|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2||||0.7|TWO_SIDED|95.0|-0.7|1.1|||ANCOVA|||Hypohesis: There is a signifcant difference in affective subscale pain scores between curcumin and placebo groups.||1.1|-0.7|0.700
72570177|NCT02504671|144670135|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-4.8|15.6|||||Week 32, ACR50. Difference to Placebo for Week 32 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||15.6|-4.8|
72570178|NCT02504671|144670135|OTHER||Difference|18.9|||||TWO_SIDED|95.0|4.7|33.2|||||Week 32, ACR50. Difference to Placebo for Week 32 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||33.2|4.7|
72570179|NCT02504671|144670135|OTHER||Difference|13.5|||||TWO_SIDED|95.0|0.5|26.5|||||Week 32, ACR50. Difference to Placebo for Week 32 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||26.5|0.5|
72570180|NCT02504671|144670135|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-6.3|11.7|||||Week 32, ACR70. Difference to Placebo for Week 32 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||11.7|-6.3|
72570181|NCT02504671|144670135|OTHER||Difference|16.2|||||TWO_SIDED|95.0|2.6|29.9|||||Week 32, ACR70. Difference to Placebo for Week 32 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||29.9|2.6|
72570182|NCT02504671|144670135|OTHER||Difference|10.8|||||TWO_SIDED|95.0|-1.4|23.0|||||Week 32, ACR70. Difference to Placebo for Week 32 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||23.0|-1.4|
72570183|NCT02504671|144670135|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-4.8|15.6|||||Week 36, ACR20. Difference to Placebo for Week 36 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||15.6|-4.8|
72570184|NCT02504671|144670135|OTHER||Difference|16.2|||||TWO_SIDED|95.0|2.6|29.9|||||Week 36, ACR20. Difference to Placebo for Week 36 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||29.9|2.6|
72570185|NCT02504671|144670135|OTHER||Difference|13.5|||||TWO_SIDED|95.0|0.5|26.5|||||Week 36, ACR20. Difference to Placebo for Week 36 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||26.5|0.5|
72570186|NCT02504671|144670135|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-6.3|11.7|||||Week 36, ACR50. Difference to Placebo for Week 36 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||11.7|-6.3|
72570187|NCT02504671|144670135|OTHER||Difference|16.2|||||TWO_SIDED|95.0|2.6|29.9|||||Week 36, ACR50. Difference to Placebo for Week 36 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||29.9|2.6|
72570188|NCT02504671|144670135|OTHER||Difference|8.1|||||TWO_SIDED|95.0|-3.2|19.4|||||Week 36, ACR50. Difference to Placebo for Week 36 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||19.4|-3.2|
72570189|NCT02504671|144670135|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||Week 36, ACR70. Difference to Placebo for Week 36 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
72406051|NCT00653224|144320397|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.065||95.0|-0.21|0.01||If the p-value of this estimated difference is lower than 5% the post-nasal drip mean score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the Post-Nasal Drip Mean Score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The post-nasal drip mean score over the total treatment period is not different from subjects treated with levocetirizine than subjects treated with placebo.'||0.01|-0.21|0.065
72406052|NCT00653224|144320398|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.21|||<|0.001||95.0|-0.32|-0.1||If the p-value of this estimated difference is lower than 5% the ocular pruritus mean score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the Ocular Pruritus Mean Score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The ocular pruritus mean score over week 1 is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.10|-0.32|<0.001
72406053|NCT00653224|144320399|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2||||0.002||95.0|-0.33|-0.08||If the p-value of this estimated difference is lower than 5% the ocular pruritus mean score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the Ocular Pruritus Mean Score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The ocular pruritus mean score over week 2 is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.08|-0.33|0.002
72522064|NCT01042938|144573680|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2||||0.559|TWO_SIDED|95.0|-0.4|0.7|||ANCOVA|||Hypothesis: There is a significant difference in mean perceived pain scores between curcumin and placebo groups.||0.7|-0.4|0.559
72522065|NCT03136484|144573681|NON_INFERIORITY|The non-inferiority p-value was calculated as two times the one-sided p-value from a t-distributed test statistic comparing the treatment contrast with 0.3 rather than zero as in a superiority test.|Treatment difference|-0.49|||<|0.0001|TWO_SIDED|95.0|-0.65|-0.33|||ANCOVA||Semaglutide + canagliflozin placebo vs Canagliflozin + semaglutide placebo|The responses were analysed using an analysis of covariance (ANCOVA) with treatment, region and stratification factor as fixed factors and baseline value as covariate. Before analysis, missing data were multiple imputed using observed data from participants within the same group defined by randomised treatment, using a regression model including region and stratification factor as categorical effects and data from baseline and all previous visits as covariates.||-0.33|-0.65|<.0001
72522066|NCT03136484|144573681|SUPERIORITY||Treatment difference|-0.49|||<|0.0001|TWO_SIDED|95.0|-0.65|-0.33|||ANCOVA||Semaglutide + canagliflozin placebo vs Canagliflozin + semaglutide placebo|The responses were analysed using an ANCOVA with treatment, region and stratification factor as fixed factors and baseline value as covariate. Before analysis, missing data were multiple imputed using observed data from participants within the same group defined by randomised treatment, using a regression model including region and stratification factor as categorical effects and data from baseline and all previous visits as covariates.||-0.33|-0.65|<.0001
72522067|NCT00360685|144573742|SUPERIORITY_OR_OTHER|||||||0.06|||||||Fisher Exact|||Sample size was based on the difference in the proportion of patients in each arm who were predicted to develop severe mucositis defined as clinical grade 3 or 4 per the CTCAE. A sample-size of 42 evaluable subjects per study-arm allowed detection of an absolute difference of 30%, which corresponds to a reduction in the incidence of severe mucositis from 60% in the methotrexate arm to 30% in the MMF arm (alpha=0.05, power=0.80).||||0.06
72522068|NCT00360685|144573743|SUPERIORITY_OR_OTHER|||||||0.8|||||||K-sample tests for comparing the cumulat|||||||0.8
72522069|NCT00360685|144573744|SUPERIORITY_OR_OTHER|||||||0.58|||||||Log Rank|||||||0.58
72522070|NCT00856986|144573766|SUPERIORITY_OR_OTHER||Estimated Treatment Difference, LSMean|-0.52||||||95.0|-0.68|-0.36|||ANCOVA|||The estimated treatment difference between Detemir+Lira 1.8 and Lira 1.8 as well as 95% confidence interval and p-value were calculated by an ANCOVA model with treatment, country and previous OAD as fixed factors and baseline value as covariate. The p-value reflects a two-sided test for the null hypothesis of no difference between the two treatment groups with a significance level of 5% and with the power of 90%.||-0.36|-0.68|
72522071|NCT00856986|144573767|SUPERIORITY_OR_OTHER||Estimated Treatment Difference, LSMean|-0.41||||||95.0|-0.6|-0.21|||ANCOVA||The analysis values for intensified Lira 1.8 mg subjects were kept in the treatment group and the last observation carried forward (LOCF) method was applied.|The estimated treatment difference between Detemir+Lira 1.8 and Lira 1.8 as well as 95% confidence interval and p-value were calculated by an ANCOVA model with treatment, country and previous OAD as fixed factors and baseline value as covariate. The p-value reflects a two-sided test for the null hypothesis of no difference between the two treatment groups with a significance level of 5%.||-0.21|-0.6|
72522072|NCT00856986|144573768|SUPERIORITY_OR_OTHER||Estimated treatment difference, LS mean|-0.51||||||95.0|-0.7|-0.31|||ANCOVA||The mean change in HbA1c from randomisation to week 52 was analysed including the values before intensification as LOCF for intensified subjects|||-0.31|-0.7|
72522073|NCT01176240|144573827|SUPERIORITY_OR_OTHER|||||||0.978|||||||ANCOVA|ANCOVA model that includes treatment as a factor and baseline OHQ composite score as a co-variate.||Study 306A was initially designed as a blinded interim analysis by an independent DMC to ensure that the overall study was adequately powered. Study 306A was not powered to provide statistical significance as a stand alone study. Thus, no additional efficacy end points were prospectively defined beyond the primary end point.||||0.978
72522074|NCT01176240|144573828|SUPERIORITY_OR_OTHER|||||||0.018||||||Statistical analysis plan involved a hierarchical assessment of secondary endpoints to prevent inflation of type I errors.|Mantel Haenszel|Mantel-Haenszel statistic comparing treatment groups based on rank statistics adjusted for the covariate OHSA Item 1 value at baseline.||||||0.018
72522075|NCT01176240|144573830|SUPERIORITY_OR_OTHER|||||||0.6||||||Statistical analysis plan involved a hierarchical assessment of secondary endpoints to prevent inflation of type I errors. As the first secondary endpoint was not positive, statistical analysis was not performed on additional secondary endpoints.|Wilcoxon (Mann-Whitney)|Mantel-Haenszel statistic comparing treatment groups based on rank statistics adjusted for the covariate OHSA Item 1 value at baseline.||||||0.60
72522076|NCT01176240|144573836|SUPERIORITY_OR_OTHER|||||||0.238|||||||ANCOVA|ANCOVA model that includes treatment as a factor and baseline OHQ composite score as a co-variate.||||||0.238
72522077|NCT00937326|144573912|SUPERIORITY|||||||0.4816||||||No adjustments for covariates were made.|Fisher Exact|||Placebo versus SRT2104 0.25 g/day in number of participants with any AE.||||0.4816
72406054|NCT00653224|144320400|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.21|||<|0.001||95.0|-0.32|-0.1||If the p-value of this estimated difference is lower than 5% the ocular pruritus mean score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the Ocular Pruritus Mean Score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The ocular pruritus mean score over the total treatment period is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.10|-0.32|<0.001
72406055|NCT00653224|144320401|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.19|||<|0.001||95.0|-0.3|-0.08||If the p-value of this estimated difference is lower than 5% the ocular itching/burning mean score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the Ocular Itching/Burning Mean Score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The ocular itching/burning mean score over Week 1 is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.08|-0.30|<0.001
72406056|NCT00653224|144320402|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.17||||0.006||95.0|-0.29|-0.05||If the p-value of this estimated difference is lower than 5% the ocular itching/burning mean score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the Ocular Itching/Burning Mean Score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The ocular itching/burning mean score over Week 2 is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.05|-0.29|0.006
72522078|NCT00937326|144573912|SUPERIORITY|||||||0.1147||||||No adjustments for covariates were made.|Fisher Exact|||Placebo versus SRT2104 0.5 g/day in number of participants with any AE.||||0.1147
72522079|NCT00937326|144573912|SUPERIORITY|||||||1||||||No adjustments for covariates were made.|Fisher Exact|||Placebo versus SRT2104 1.0 g/day in number of participants with any AE.||||1.0000
72522080|NCT00937326|144573912|SUPERIORITY|||||||0.4816||||||No adjustments for covariates were made.|Fisher Exact|||Placebo versus SRT2104 2.0 g/day in number of participants with any AE.||||0.4816
72522081|NCT00937326|144573936|OTHER|The analysis used an Estimation approach. No hypothesis testing was performed.|Ratio|168.4|||||TWO_SIDED|90.0|123.87|228.94|||ANOVA|Results obtained from a mixed model ANOVA on log10-transformed data with fixed effect of study day and a random effect of participant.|The difference in least squares means and corresponding confidence interval (CI) were back-transformed to form ratio of geometric least squares means (Day 28/ Day 1) and CI.|Day 28 versus Day 1 for AUC 0-t of SRT2104 0.25 g/day.||228.94|123.87|
72522082|NCT00937326|144573936|OTHER|The analysis used an Estimation approach. No hypothesis testing was performed.|Ratio|110.88|||||TWO_SIDED|90.0|88.18|139.43|||ANOVA|Results obtained from a mixed model ANOVA on log10-transformed data with fixed effect of study day and a random effect of participant.|The difference in least squares means and corresponding CI were back-transformed to form ratio of geometric least squares means (Day 28/ Day 1) and CI. AUC values included in the analysis were AUC 0-infinity on Day 1 and AUC 0-τ on Day 28.|Day 28 versus Day 1 for AUC 0-infinity of SRT2104 0.25 g/day.||139.43|88.18|
72522083|NCT00937326|144573936|OTHER|The analysis used an Estimation approach. No hypothesis testing was performed.|Ratio|133.11|||||TWO_SIDED|90.0|100.55|176.21|||ANOVA|Results obtained from a mixed model ANOVA on log10-transformed data with fixed effect of study day and a random effect of participant.|The difference in least squares means and corresponding CI were back-transformed to form ratio of geometric least squares means (Day 28/ Day 1) and CI.|Day 28 versus Day 1 for AUC 0-t of SRT2104 0.5 g/day.||176.21|100.55|
72522084|NCT00937326|144573936|OTHER|The analysis used an Estimation approach. No hypothesis testing was performed.|Other|94.3|||||TWO_SIDED|90.0|70.31|126.48|||ANOVA|Results obtained from a mixed model ANOVA on log10-transformed data with fixed effect of study day and a random effect of participant.|The difference in least squares means and corresponding CI were back-transformed to form ratio of geometric least squares means (Day 28/ Day 1) and CI. The AUC values included in the analysis were AUC 0-infinity on Day 1 and AUC 0-τ on Day 28.|Day 28 versus Day 1 for AUC 0-infinity of SRT2104 0.5 g/day.||126.48|70.31|
72522085|NCT00937326|144573936|OTHER|The analysis used an Estimation approach. No hypothesis testing was performed.|Ratio|141.63|||||TWO_SIDED|90.0|111.2|180.39|||ANOVA|Results obtained from a mixed model ANOVA on log10-transformed data with fixed effect of study day and a random effect of participant.|The difference in least squares means and corresponding CI were back-transformed to form ratio of geometric least squares means (Day 28/ Day 1) and CI.|Day 28 versus Day 1 for AUC 0-t of SRT2104 1.0 g/day.||180.39|111.20|
72522086|NCT00937326|144573936|OTHER|The analysis used an Estimation approach. No hypothesis testing was performed.|Ratio|114.46|||||TWO_SIDED|90.0|85.56|153.11|||ANOVA|Results obtained from a mixed model ANOVA on log10-transformed data with fixed effect of study day and a random effect of participant.|The difference in least squares means and corresponding CI were back-transformed to form ratio of geometric least squares means (Day 28/ Day 1) and CI. The AUC values included in the analysis were AUC 0-infinity on Day 1 and AUC 0-τ on Day 28.|Day 28 versus Day 1for AUC 0-infinity of SRT2104 1.0 g/day.||153.11|85.56|
72522087|NCT00937326|144573936|OTHER|The analysis used an Estimation approach. No hypothesis testing was performed.|Ratio|167.09|||||TWO_SIDED|90.0|120.73|231.25|||ANOVA|Results obtained from a mixed model ANOVA on log10-transformed data with fixed effect of study day and a random effect of participant.|The difference in least squares means and corresponding CI were back-transformed to form ratio of geometric least squares means (Day 28/ Day 1) and CI.|Day 28 versus Day 1 for AUC 0-t of SRT2104 2.0 g/day.||231.25|120.73|
72522088|NCT00937326|144573936|OTHER|The analysis used an Estimation approach. No hypothesis testing was performed.|Ratio|117.73|||||TWO_SIDED|90.0|85.14|162.79|||ANOVA|Results obtained from a mixed model ANOVA on log10-transformed data with fixed effect of study day and a random effect of participant.|The difference in least squares means and corresponding CI were back-transformed to form ratio of geometric least squares means (Day 28/ Day 1) and CI. The AUC values included in the analysis were AUC 0-infinity on Day 1 and AUC 0-τ on Day 28.|Day 28 versus Day 1 for AUC 0-infinity of SRT2104 2.0 g/day.||162.79|85.14|
72522089|NCT00937326|144573937|OTHER|The analysis used an Estimation approach. No hypothesis testing was performed.|Ratio|122.22|||||TWO_SIDED|90.0|86.94|171.8|||ANOVA|Results obtained from a mixed model ANOVA on log10-transformed data with fixed effect of study day and a random effect of participant.|The difference in least squares means and corresponding CI were back-transformed to form ratio of geometric least squares means (Day 28/ Day 1) and CI.|Day 28 versus Day 1 for Cmax of SRT2104 0.25 g/day.||171.80|86.94|
72522090|NCT00937326|144573937|OTHER|The analysis used an Estimation approach. No hypothesis testing was performed.|Ratio|94.45|||||TWO_SIDED|90.0|69.07|129.16|||ANOVA|Results obtained from a mixed model ANOVA on log10-transformed data with fixed effect of study day and a random effect of participant.|The difference in least squares means and corresponding CI were back-transformed to form ratio of geometric least squares means (Day 28/ Day 1) and CI.|Day 28 versus Day 1 for Cmax of SRT2104 0.5 g/day.||129.16|69.07|
72522091|NCT00937326|144573937|OTHER|The analysis used an Estimation approach. No hypothesis testing was performed.|Ratio|114.79|||||TWO_SIDED|90.0|91.54|143.95|||ANOVA|Results obtained from a mixed model ANOVA on log10-transformed data with fixed effect of study day and a random effect of participant.|The difference in least squares means and corresponding CI were back-transformed to form ratio of geometric least squares means (Day 28/ Day 1) and CI.|Day 28 versus Day 1 for Cmax of SRT2104 1.0 g/day.||143.95|91.54|
72522092|NCT00937326|144573937|OTHER|The analysis used an Estimation approach. No hypothesis testing was performed.|Ratio|120.3|||||TWO_SIDED|90.0|88.66|163.23|||ANOVA|Results obtained from a mixed model ANOVA on log10-transformed data with fixed effect of study day and a random effect of participant.|The difference in least squares means and corresponding CI were back-transformed to form ratio of geometric least squares means (Day 28/ Day 1) and CI.|Day 28 versus Day 1 for Cmax of SRT2104 2.0 g/day.||163.23|88.66|
72522093|NCT00937326|144573942|SUPERIORITY|||||||0.997||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.25 g/day on Day 8 for FPG.||||0.997
72522094|NCT00937326|144573942|SUPERIORITY|||||||0.581||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.5 g/day on Day 8 for FPG.||||0.581
72522095|NCT00937326|144573942|SUPERIORITY|||||||0.987||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 1.0 g/day on Day 8 for FPG.||||0.987
72522096|NCT00937326|144573942|SUPERIORITY|||||||0.999||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 2.0 g/day on Day 8 for FPG.||||0.999
72522097|NCT00937326|144573942|SUPERIORITY|||||||0.85||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.25 g/day on Day 15 for FPG.||||0.850
72522098|NCT00937326|144573942|SUPERIORITY|||||||0.843||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.5 g/day on Day 15 for FPG.||||0.843
72522099|NCT00937326|144573942|SUPERIORITY|||||||0.961||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 1.0 g/day on Day 15 for FPG.||||0.961
72522100|NCT00937326|144573942|SUPERIORITY|||||||0.939||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 2.0 g/day on Day 15 for FPG.||||0.939
72522101|NCT00937326|144573942|SUPERIORITY|||||||0.966||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.25 g/day on Day 22 for FPG.||||0.966
72522102|NCT00937326|144573942|SUPERIORITY|||||||0.075||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.5 g/day on Day 22 for FPG.||||0.075
72522103|NCT00937326|144573942|SUPERIORITY|||||||0.7||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 1.0 g/day on Day 22 for FPG.||||0.700
72522104|NCT00937326|144573942|SUPERIORITY|||||||0.732||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 2.0 g/day on Day 22 for FPG.||||0.732
72625033|NCT01383005|144779701|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.16||||0.001|TWO_SIDED|95.0|0.052|0.494|||Regression, Logistic|Degree of freedom is 1 for the independent variable 'viral load change from detectable to undetectable.'|Stepwise procedures forward and backward were used to select variables in the model using entry and exit probabilities of 0.05 and 0.1 respectively. Identical models were obtained by forward and backward selection procedures.|Statistical Analysis 1 presents the risk of a 'mean score \<5' on the HIVTSQ overall satisfaction dimension (see Outcome Measure 8) when correlated with a viral load change from 'detectable to undetectable' in the last model of the Wald test.||0.494|0.052|0.001
72625034|NCT01383005|144779701|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.279||||0.072|TWO_SIDED|95.0|0.07|1.118|||Regression, Logistic|Degree of freedom is 1 for the independent variable 'viral load change from undetectable to undetectable.'|Stepwise procedures forward and backward were used to select variables in the model using entry and exit probabilities of 0.05 and 0.1 respectively. Identical models were obtained by forward and backward selection procedures.|Statistical Analysis 2 presents the risk of a 'mean score \<5' on the HIVTSQ overall satisfaction dimension (see Outcome Measure 8) when correlated with a viral load change from 'undetectable to undetectable' in the last model of the Wald test.||1.118|0.070|0.072
72625035|NCT01383005|144779702|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.996||||0.025|TWO_SIDED|95.0|0.992|0.999|||Regression, Logistic|Degree of freedom is 1 for the independent variable 'time on LPV/r.'|Stepwise procedures forward and backward were used to select variables in the model using entry and exit probabilities of 0.05 and 0.1 respectively. Identical models were obtained by forward and backward selection procedures.|Statistical Analysis 1 presents the risk of a 'mean score \<5' on the HIVTSQ overall satisfaction dimension (see Outcome Measure 8) when correlated with time on treatment with LPV/r QD in the last model of the Wald test.||0.999|0.992|0.025
72625036|NCT00895921|144779705|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.242|STANDARD_ERROR_OF_MEAN|0.1139||0.042|TWO_SIDED|95.0|0.00943|0.47605||The a priori threshold for statistical significance is \<0.05.|t-test, 2 sided|||||.47605|.00943|0.042
72522105|NCT00937326|144573942|SUPERIORITY|||||||0.552||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.25 g/day on Day 28 for FPG.||||0.552
72522106|NCT00937326|144573942|SUPERIORITY|||||||0.196||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.5 g/day on Day 28 for FPG.||||0.196
72522107|NCT00937326|144573942|SUPERIORITY|||||||0.393||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 1.0 g/day on Day 28 for FPG.||||0.393
72522108|NCT00937326|144573942|SUPERIORITY|||||||0.775||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 2.0 g/day on Day 28 for FPG.||||0.775
72522109|NCT00937326|144573942|SUPERIORITY|||||||1||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.25 g/day on Day 35 for FPG.||||1.000
72625037|NCT00895921|144779706|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.253|STANDARD_ERROR_OF_MEAN|0.224||0.269|TWO_SIDED|95.0|-0.208|0.714||The a priori threshold for statistical significance was \< 0.05.|t-test, 2 sided|||||0.714|-0.208|0.269
72625038|NCT00895921|144779707|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.4|STANDARD_ERROR_OF_MEAN|0.149||0.012|TWO_SIDED|95.0|0.095|0.705|||Chi-squared, Corrected|||Comparison of akathisia rates between the two arms.||.705|.095|0.012
72625039|NCT03243084|144779712|SUPERIORITY|||||||0.319||||||Threshold for significance is \<.05.|ANOVA|||A 2x2 ANOVA was used to measure change in HF-HRV by condition (10 Hz vs sham) and session (first vs second) as within subjects variables||||.319
72625040|NCT03243084|144779714|SUPERIORITY|||||||0.0488||||||Threshold for significance is \<.05.|Wilcoxon (Mann-Whitney)|||Investigators hypothesized that active stimulation would have a greater normalized pain change using a modulation index \[(Pre-Post)/(Pre+Post)\]||||.0488
72406057|NCT00653224|144320403|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.18|||<|0.001||95.0|-0.29|-0.08||If the p-value of this estimated difference is lower than 5% the ocular itching/burning mean score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the Ocular Itching/Burning Mean Score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The ocular itching/burning mean score over the total treatment period is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.08|-0.29|<0.001
72522110|NCT00937326|144573942|SUPERIORITY|||||||0.989||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.5 g/day on Day 35 for FPG.||||0.989
72625041|NCT02300233|144779715|SUPERIORITY||Difference in Least Squares Mean (LSM)|-70.3|||<|0.0001|TWO_SIDED|95.0|-85.4|-55.3|||ANCOVA|||||-55.3|-85.4|<0.0001
72522111|NCT00937326|144573942|SUPERIORITY|||||||0.603||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 1.0 g/day on Day 35 for FPG.||||0.603
72522112|NCT00937326|144573942|SUPERIORITY|||||||0.108||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 2.0 g/day on Day 35 for FPG.||||0.108
72522113|NCT00937326|144573943|SUPERIORITY|||||||0.525||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.25 g/day for change from Baseline in FPG on Day 8.||||0.525
72522114|NCT00937326|144573943|SUPERIORITY|||||||0.818||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.5 g/day for change from Baseline in FPG on Day 8.||||0.818
72522115|NCT00937326|144573943|SUPERIORITY|||||||0.999||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 1.0 g/day for change from Baseline in FPG on Day 8.||||0.999
72522116|NCT00937326|144573943|SUPERIORITY|||||||0.809||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 2.0 g/day for change from Baseline in FPG on Day 8.||||0.809
72522117|NCT00937326|144573943|SUPERIORITY|||||||0.993||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.25 g/day for change from Baseline in FPG on Day 15.||||0.993
72522118|NCT00937326|144573943|SUPERIORITY|||||||0.954||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.5 g/day for change from Baseline in FPG on Day 15.||||0.954
72522119|NCT00937326|144573943|SUPERIORITY|||||||1||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 1.0 g/day for change from Baseline in FPG on Day 15.||||1.000
72522120|NCT00937326|144573943|SUPERIORITY|||||||0.344||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 2.0 g/day for change from Baseline in FPG on Day 15.||||0.344
72522121|NCT00937326|144573943|SUPERIORITY|||||||0.968||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.25 g/day for change from Baseline in FPG on Day 22.||||0.968
72522122|NCT00937326|144573943|SUPERIORITY|||||||0.316||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.5 g/day for change from Baseline in FPG on Day 22.||||0.316
72522123|NCT00937326|144573943|SUPERIORITY|||||||0.984||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 1.0 g/day for change from Baseline in FPG on Day 22.||||0.984
72570190|NCT02504671|144670135|OTHER||Difference|18.9|||||TWO_SIDED|95.0|6.3|31.5|||||Week 36, ACR70. Difference to Placebo for Week 36 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||31.5|6.3|
72570191|NCT02504671|144670135|OTHER||Difference|10.8|||||TWO_SIDED|95.0|0.8|20.8|||||Week 36, ACR70. Difference to Placebo for Week 36 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||20.8|0.8|
72570192|NCT02504671|144670135|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-4.8|15.6|||||Week 40, ACR20. Difference to Placebo for Week 40 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||15.6|-4.8|
72570193|NCT02504671|144670135|OTHER||Difference|16.2|||||TWO_SIDED|95.0|2.6|29.9|||||Week 40, ACR20. Difference to Placebo for Week 40 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||29.9|2.6|
72625042|NCT02300233|144779716|SUPERIORITY||Difference in LSM|-943.0|||<|0.0001|TWO_SIDED|95.0|-1197.0|-689.0|||ANCOVA|||||-689|-1197|<0.0001
72570194|NCT02504671|144670135|OTHER||Difference|18.9|||||TWO_SIDED|95.0|4.7|33.2|||||Week 40, ACR20. Difference to Placebo for Week 40 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||33.2|4.7|
72406058|NCT00653224|144320404|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|||<|0.001||95.0|-0.31|-0.1||If the p-value of this estimated difference is lower than 5% the ocular tearing/watering mean score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the Ocular Tearing/Watering Mean Score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The ocular tearing/watering mean score over week 1 is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.10|-0.31|<0.001
72406059|NCT00653224|144320405|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.16||||0.011||95.0|-0.29|-0.04||If the p-value of this estimated difference is lower than 5% the ocular tearing/watering mean score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the Ocular Tearing/Watering Mean Score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The ocular tearing/watering mean score over week 2 is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.04|-0.29|0.011
72522124|NCT00937326|144573943|SUPERIORITY|||||||0.235||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 2.0 g/day for change from Baseline in FPG on Day 22.||||0.235
72522125|NCT00937326|144573943|SUPERIORITY|||||||1||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.25 g/day for change from Baseline in FPG on Day 28.||||1.000
72522126|NCT00937326|144573943|SUPERIORITY|||||||0.656||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.5 g/day for change from Baseline in FPG on Day 28.||||0.656
72522127|NCT00937326|144573943|SUPERIORITY|||||||0.994||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 1.0 g/day for change from Baseline in FPG on Day 28.||||0.994
72522128|NCT00937326|144573943|SUPERIORITY|||||||0.285||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 2.0 g/day for change from Baseline in FPG on Day 28.||||0.285
72522129|NCT00937326|144573943|SUPERIORITY|||||||0.992||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.25 g/day for change from Baseline in FPG on Day 35.||||0.992
72522130|NCT00937326|144573943|SUPERIORITY|||||||0.822||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.5 g/day for change from Baseline in FPG on Day 35.||||0.822
72522131|NCT00937326|144573943|SUPERIORITY|||||||0.538||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 1.0 g/day for change from Baseline in FPG on Day 35.||||0.538
72522132|NCT00937326|144573943|SUPERIORITY|||||||0.907||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 2.0 g/day for change from Baseline in FPG on Day 35.||||0.907
72522133|NCT00937326|144573944|SUPERIORITY|||||||0.999||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.25 g/day on Day 8 for FPI.||||0.999
72522134|NCT00937326|144573944|SUPERIORITY|||||||0.982||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.5 g/day on Day 8 for FPI.||||0.982
72522135|NCT00937326|144573944|SUPERIORITY|||||||0.677||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 1.0 g/day on Day 8 for FPI.||||0.677
72522136|NCT00937326|144573944|SUPERIORITY|||||||0.688||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 2.0 g/day on Day 8 for FPI.||||0.688
72625043|NCT02300233|144779717|SUPERIORITY||Odds Ratio (OR)|96.02|||<|0.0001|TWO_SIDED|95.0|19.71|467.79|||Regression, Logistic|||||467.79|19.71|<0.0001
72406060|NCT00653224|144320406|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.18|||<|0.001||95.0|-0.29|-0.08||If the p-value of this estimated difference is lower than 5% the ocular tearing/watering mean score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the Ocular Tearing/Watering Mean Score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The ocular tearing/watering mean score over the total treatment period is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.08|-0.29|<0.001
72406061|NCT00653224|144320407|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.16||||0.004||95.0|-0.27|-0.05||If the p-value of this estimated difference is lower than 5% the ocular redness mean score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the Ocular Redness Mean Score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The ocular redness mean score over week 1 is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.05|-0.27|0.004
72406062|NCT00653224|144320408|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.22|||<|0.001||95.0|-0.34|-0.1||If the p-value of this estimated difference is lower than 5% the ocular redness mean score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the Ocular Redness Mean Score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The ocular redness mean score over week 2 is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.10|-0.34|<0.001
72406063|NCT00653224|144320409|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.19|||<|0.001||95.0|-0.29|-0.08||If the p-value of this estimated difference is lower than 5% the ocular redness mean score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the Ocular Redness Mean Score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The ocular redness mean score over the total treatment period is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.08|-0.29|<0.001
72406064|NCT00653224|144320410|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||If the p-value is lower than 5% the distribution is considered as different between the two treatment groups.|Wilcoxon (Mann-Whitney)|||The Wilcoxon-Mann-Whitney, or Wilcoxon rank-sum test is generally used to detect 'shift alternatives'. That is, the two distributions have the same general shape, but one of them is shifted relative to the other by a constant amount under the alternative hypothesis.||||<0.001
72406065|NCT00653224|144320411|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||If the p-value is lower than 5% the distribution is considered as different between the two treatment groups.|Wilcoxon (Mann-Whitney)|||The Wilcoxon-Mann-Whitney, or Wilcoxon rank-sum test (Lehmann, 1975 page 23) is generally used to detect 'shift alternatives'. That is, the two distributions have the same general shape, but one of them is shifted relative to the other by a constant amount under the alternative hypothesis.||||<0.001
72406066|NCT00653224|144320412|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.36||||0.027||95.0|-2.56|-0.16||If the p-value of this estimated difference is lower than 5% the mean change from baseline in WPAI-AS score (dimension 1) is considered as different between the two treatment groups.|ANCOVA|ANCOVA on change from baseline in the WPAI:AS score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean change from baseline in WPAI-AS score (dimension 1) at endpoint visit is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.16|-2.56|0.027
72406067|NCT00653224|144320413|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.36||||0.554||95.0|-1.56|0.84||If the p-value of this estimated difference is lower than 5% the mean change from baseline in WPAI-AS score (dimension 1) is considered as different between the two treatment groups.|ANCOVA|ANCOVA on change from baseline in the WPAI:AS score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean change from baseline in WPAI-AS score (dimension 1) at week 1 is not different from subjects treated with levocetirizine than subjects treated with placebo.'||0.84|-1.56|0.554
72522137|NCT00937326|144573944|SUPERIORITY|||||||0.903||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.25 g/day on Day 15 for FPI.||||0.903
72522138|NCT00937326|144573944|SUPERIORITY|||||||0.945||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.5 g/day on Day 15 for FPI.||||0.945
72570195|NCT02504671|144670135|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-4.8|15.6|||||Week 40, ACR50. Difference to Placebo for Week 40 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||15.6|-4.8|
72570196|NCT02504671|144670135|OTHER||Difference|13.5|||||TWO_SIDED|95.0|0.5|26.5|||||Week 40, ACR50. Difference to Placebo for Week 40 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||26.5|0.5|
72522139|NCT00937326|144573944|SUPERIORITY|||||||0.949||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 1.0 g/day on Day 15 for FPI.||||0.949
72570197|NCT02504671|144670135|OTHER||Difference|10.8|||||TWO_SIDED|95.0|-1.4|23.0|||||Week 40, ACR50. Difference to Placebo for Week 40 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||23.0|-1.4|
72570198|NCT02504671|144670135|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-6.3|11.7|||||Week 40, ACR70. Difference to Placebo for Week 40 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||11.7|-6.3|
72625044|NCT02300233|144779718|SUPERIORITY||Difference in LSM|56.8|||<|0.0001|TWO_SIDED|95.0|45.1|68.6|||ANCOVA|||||68.6|45.1|<0.0001
72406068|NCT00653224|144320414|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.5||||0.015||95.0|-2.72|-0.29||If the p-value of this estimated difference is lower than 5% the mean change from baseline in WPAI-AS score (dimension 1) is considered as different between the two treatment groups.|ANCOVA|ANCOVA on change from baseline in the WPAI:AS score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean change from baseline in WPAI-AS score (dimension 1) at week 2 is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.29|-2.72|0.015
72406069|NCT00653224|144320415|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.6||||0.016||95.0|-8.34|-0.86||If the p-value of this estimated difference is lower than 5% the mean change from baseline in WPAI-AS score (dimension 2) is considered as different between the two treatment groups.|ANCOVA|ANCOVA on change from baseline in the WPAI:AS score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean change from baseline in WPAI-AS score (dimension 2) at endpoint visit is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.86|-8.34|0.016
72406070|NCT00653224|144320416|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.33||||0.017||95.0|-7.88|-0.79||If the p-value of this estimated difference is lower than 5% the mean change from baseline in WPAI-AS score (dimension 2) is considered as different between the two treatment groups.|ANCOVA|ANCOVA on change from baseline in the WPAI:AS score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean change from baseline in WPAI-AS score (dimension 2) at week 1 is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.79|-7.88|0.017
72406071|NCT00653224|144320417|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.25||||0.027||95.0|-8.02|-0.47||If the p-value of this estimated difference is lower than 5% the mean change from baseline in WPAI-AS score (dimension 2) is considered as different between the two treatment groups.|ANCOVA|ANCOVA on change from baseline in the WPAI:AS score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean change from baseline in WPAI-AS score (dimension 2) at week 2 is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.47|-8.02|0.027
72406072|NCT00653224|144320418|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.44||||0.023||95.0|-8.25|-0.63||If the p-value of this estimated difference is lower than 5% the mean change from baseline in WPAI-AS score (dimension 3) is considered as different between the two treatment groups.|ANCOVA|ANCOVA on change from baseline in the WPAI:AS score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean change from baseline in WPAI-AS score (dimension 3) at endpoint visit is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.63|-8.25|0.023
72625045|NCT02300233|144779719|SUPERIORITY||Odds Ratio (OR)|14.93||||0.0474|TWO_SIDED|95.0|1.03|215.88|||Regression, Logistic|||||215.88|1.03|0.0474
72406073|NCT00653224|144320419|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.56||||0.015||95.0|-8.23|-0.89||If the p-value of this estimated difference is lower than 5% the mean change from baseline in WPAI-AS score (dimension 3) is considered as different between the two treatment groups.|ANCOVA|ANCOVA on change from baseline in the WPAI:AS score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean change from baseline in WPAI-AS score (dimension 3) at week 1 is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.89|-8.23|0.015
72542525|NCT01010230|144614889|NON_INFERIORITY_OR_EQUIVALENCE|The power calculation was based on the primary aim and is provided above.|Mean Difference (Final Values)|0.18||||0.18|TWO_SIDED|95.0|0.0|0.35||The threshold for significance was established a priori at alpha=0.05.|t-test, 2 sided|||Active and placebo group means were compared with a 2-sample t-test after log-transforming the variable.||0.35|0.00|0.18
72542526|NCT01010230|144614890|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.16||||0.85|TWO_SIDED|95.0|-6.93|9.25||The threshold for significance was established a priori at alpha=0.05|ANOVA|BMC was normalized for height and adjusted for sex and tanner stage.||The power estimates were based on two-sided two-sample t-tests. With 30 subjects in each of the two arms and assuming no change in the control arm (0% change) and assuming the common standard deviation (SD) of 6.8% we estimated 87% power to detect an improvement of 5.5% change in the intervention arm, with type I error control α=0.05.||9.25|-6.93|0.85
72542527|NCT01010230|144614891|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.19||||0.12|TWO_SIDED|95.0|0.43|5.95||The threshold for significance was established a priori at alpha=0.05.|ANOVA|Adjusted for sex and tanner stage.||The power estimates were based on two-sided two-sample t-tests. With 30 subjects in each of the two arms and assuming no change in the control arm (0% change) and assuming the common standard deviation (SD) of 6.8%3 we estimated 87% power to detect an improvement of 5.5% change in the intervention arm, with type I error control α=0.05.||5.95|0.43|0.12
72542528|NCT01010230|144614892|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.97|TWO_SIDED|95.0|-4.24|4.05||The threshold for significance was established a priori at alpha=0.05.|ANOVA|Adjusted for sex and tanner stage (from general linear model).||The power estimates were based on two-sided two-sample t-tests. With 30 subjects in each of the two arms and assuming no change in the control arm (0% change) and assuming the common standard deviation (SD) of 6.8%3 we estimated 87% power to detect an improvement of 5.5% change in the intervention arm, with type I error control α=0.05.||4.05|-4.24|0.97
72542529|NCT01010230|144614893|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.34||||0.91|TWO_SIDED|95.0|-4.05|4.68||The threshold for significance was established a priori at alpha=0.05.|ANOVA|Adjusted for sex and tanner stage.||The power estimates were based on two-sided two-sample t-tests. With 30 subjects in each of the two arms and assuming no change in the control arm (0% change) and assuming the common standard deviation (SD) of 6.8%3 we estimated 87% power to detect an improvement of 5.5% change in the intervention arm, with type I error control α=0.05.||4.68|-4.05|0.91
72522140|NCT00937326|144573944|SUPERIORITY|||||||0.924||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 2.0 g/day on Day 15 for FPI.||||0.924
72625046|NCT04380142|144779724|SUPERIORITY||Least Squares (LS) Mean of Difference|1.75|STANDARD_ERROR_OF_MEAN|0.65||0.0083|TWO_SIDED|95.0|0.46|3.05||The model included fixed categorical effects of treatment, country and visit, baseline-by-visit and treatment-by-visit interactions, and baseline as a covariate. An unstructured variance-covariance matrix was used.|mixed model repeated measures|||||3.05|0.46|0.0083
72522141|NCT00937326|144573944|SUPERIORITY|||||||0.394||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.25 g/day on Day 22 for FPI.||||0.394
72522142|NCT00937326|144573944|SUPERIORITY|||||||0.687||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.5 g/day on Day 22 for FPI.||||0.687
72522143|NCT00937326|144573944|SUPERIORITY|||||||0.568||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 1.0 g/day on Day 22 for FPI.||||0.568
72522144|NCT00937326|144573944|SUPERIORITY|||||||0.486||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 2.0 g/day on Day 22 for FPI.||||0.486
72522145|NCT00937326|144573944|SUPERIORITY|||||||0.973||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.25 g/day on Day 28 for FPI.||||0.973
72522146|NCT00937326|144573944|SUPERIORITY|||||||0.739||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.5 g/day on Day 28 for FPI.||||0.739
72522147|NCT00937326|144573944|SUPERIORITY|||||||0.731||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 1.0 g/day on Day 28 for FPI.||||0.731
72522148|NCT00937326|144573944|SUPERIORITY|||||||0.991||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 2.0 g/day on Day 28 for FPI.||||0.991
72522149|NCT00937326|144573944|SUPERIORITY|||||||0.994||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.25 g/day on Day 35 for FPI.||||0.994
72522150|NCT00937326|144573944|SUPERIORITY|||||||0.963||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.5 g/day on Day 35 for FPI.||||0.963
72522151|NCT00937326|144573944|SUPERIORITY|||||||0.929||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 1.0 g/day on Day 35 for FPI.||||0.929
72522152|NCT00937326|144573944|SUPERIORITY|||||||0.97||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 2.0 g/day on Day 35 for FPI.||||0.970
72522153|NCT00937326|144573945|SUPERIORITY|||||||0.989||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.25 g/day for change from Baseline in FPI on Day 8.||||0.989
72522154|NCT00937326|144573945|SUPERIORITY|||||||0.989||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.5 g/day for change from Baseline in FPI on Day 8.||||0.989
72406074|NCT00653224|144320420|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.11||||0.036||95.0|-7.95|-0.27||If the p-value of this estimated difference is lower than 5% the mean change from baseline in WPAI-AS score (dimension 3) is considered as different between the two treatment groups.|ANCOVA|ANCOVA on change from baseline in the WPAI:AS score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean change from baseline in WPAI-AS score (dimension 3) at week 2 is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.27|-7.95|0.036
72406075|NCT00653224|144320421|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.51||||0.102||95.0|-9.95|0.93||If the p-value of this estimated difference is lower than 5% the mean change from baseline in WPAI-AS score (dimension 4) is considered as different between the two treatment groups.|ANCOVA|ANCOVA on change from baseline in the WPAI:AS score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean change from baseline in WPAI-AS score (dimension 4) at endpoint visit is not different from subjects treated with levocetirizine than subjects treated with placebo.'||0.93|-9.95|0.102
72406076|NCT00653224|144320422|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.44||||0.493||95.0|-5.66|2.78||If the p-value of this estimated difference is lower than 5% the mean change from baseline in WPAI-AS score (dimension 4) is considered as different between the two treatment groups.|ANCOVA|ANCOVA on change from baseline in the WPAI:AS score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean change from baseline in WPAI-AS score (dimension 4) at week 1 is not different from subjects treated with levocetirizine than subjects treated with placebo.'||2.78|-5.66|0.493
72406077|NCT00653224|144320423|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.38||||0.117||95.0|-9.91|1.15||If the p-value of this estimated difference is lower than 5% the mean change from baseline in WPAI-AS score (dimension 4) is considered as different between the two treatment groups.|ANCOVA|ANCOVA on change from baseline in the WPAI:AS score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean change from baseline in WPAI-AS score (dimension 4) at week 2 is not different from subjects treated with levocetirizine than subjects treated with placebo.'||1.15|-9.91|0.117
72406078|NCT00653224|144320424|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.58||||0.409||95.0|-15.65|6.49||If the p-value of this estimated difference is lower than 5% the mean change from baseline in WPAI-AS score (dimension 5) is considered as different between the two treatment groups.|ANCOVA|ANCOVA on change from baseline in the WPAI:AS score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean change from baseline in WPAI-AS score (dimension 5) at endpoint visit is not different from subjects treated with levocetirizine than subjects treated with placebo.'||6.49|-15.65|0.409
72406079|NCT00653224|144320425|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.54||||0.432||95.0|-16.1|7.01||If the p-value of this estimated difference is lower than 5% the mean change from baseline in WPAI-AS score (dimension 5) is considered as different between the two treatment groups.|ANCOVA|ANCOVA on change from baseline in the WPAI:AS score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean change from baseline in WPAI-AS score (dimension 5) at week 1 is not different from subjects treated with levocetirizine than subjects treated with placebo.'||7.01|-16.10|0.432
72406080|NCT00653224|144320426|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-4.24||||0.45||95.0|-15.46|6.99||If the p-value of this estimated difference is lower than 5% the mean change from baseline in WPAI-AS score (dimension 5) is considered as different between the two treatment groups.|ANCOVA|ANCOVA on change from baseline in the WPAI:AS score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean change from baseline in WPAI-AS score (dimension 5) at week 2 is not different from subjects treated with levocetirizine than subjects treated with placebo.'||6.99|-15.46|0.450
72522155|NCT00937326|144573945|SUPERIORITY|||||||0.982||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 1.0 g/day for change from Baseline in FPI on Day 8.||||0.982
72522156|NCT00937326|144573945|SUPERIORITY|||||||0.999||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 2.0 g/day for change from Baseline in FPI on Day 8.||||0.999
72522157|NCT00937326|144573945|SUPERIORITY|||||||0.685||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.25 g/day for change from Baseline in FPI on Day 15.||||0.685
72406081|NCT00653224|144320427|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.37||||0.251||95.0|-17.4|4.67||If the p-value of this estimated difference is lower than 5% the mean change from baseline in WPAI-AS score (dimension 6) is considered as different between the two treatment groups.|ANCOVA|ANCOVA on change from baseline in the WPAI:AS score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean change from baseline in WPAI-AS score (dimension 6) at endpoint visit is not different from subjects treated with levocetirizine than subjects treated with placebo.'||4.67|-17.40|0.251
72625047|NCT04380142|144779725|SUPERIORITY||LS Mean of Difference|-1.79|STANDARD_ERROR_OF_MEAN|0.63||0.0054|TWO_SIDED|95.0|-3.03|-0.54||The model included fixed categorical effects of treatment, country and visit, baseline-by-visit and treatment-by-visit interactions, and baseline as a covariate. An unstructured variance-covariance matrix was used.|mixed model repeated measures|||||-0.54|-3.03|0.0054
72625048|NCT04380142|144779726|SUPERIORITY||LS Mean of Difference|-1.58|STANDARD_ERROR_OF_MEAN|1.05||0.1318|TWO_SIDED|95.0|-3.65|0.48||The model included fixed categorical effects of treatment, country and visit, baseline-by-visit and treatment-by-visit interactions, and baseline as a covariate. An unstructured variance-covariance matrix was used.|mixed model repeated measures|||||0.48|-3.65|0.1318
72625049|NCT04380142|144779727|SUPERIORITY||Odds Ratio (OR)|0.12|STANDARD_ERROR_OF_MEAN|0.49|<=|0.001|TWO_SIDED|95.0|0.04|0.31||The generalized linear mixed model: status = treatment country visit baseline treatment\*visit. The unstructured variance-covariance structure is used.|generalized linear mixed model|||||0.31|0.04|<=0.001
72625050|NCT04380142|144779728|SUPERIORITY||Odds Ratio (OR)|1.81|STANDARD_ERROR_OF_MEAN|0.68||0.0091|TWO_SIDED|95.0|0.46|3.16|||generalized linear mixed model|||||3.16|0.46|0.0091
72522158|NCT00937326|144573945|SUPERIORITY|||||||0.999||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.5 g/day for change from Baseline in FPI on Day 15.||||0.999
72522159|NCT00937326|144573945|SUPERIORITY|||||||0.971||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 1.0 g/day for change from Baseline in FPI on Day 15.||||0.971
72522160|NCT00937326|144573945|SUPERIORITY|||||||1||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 2.0 g/day for change from Baseline in FPI on Day 15.||||1.000
72522161|NCT00937326|144573945|SUPERIORITY|||||||0.405||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.25 g/day for change from Baseline in FPI on Day 22.||||0.405
72522162|NCT00937326|144573945|SUPERIORITY|||||||0.975||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.5 g/day for change from Baseline in FPI on Day 22.||||0.975
72522163|NCT00937326|144573945|SUPERIORITY|||||||0.999||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 1.0 g/day for change from Baseline in FPI on Day 22.||||0.999
72522164|NCT00937326|144573945|SUPERIORITY|||||||0.629||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 2.0 g/day for change from Baseline in FPI on Day 22.||||0.629
72522165|NCT00937326|144573945|SUPERIORITY|||||||0.982||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.25 g/day for change from Baseline in FPI on Day 28.||||0.982
72522166|NCT00937326|144573945|SUPERIORITY|||||||0.982||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.5 g/day for change from Baseline in FPI on Day 28.||||0.982
72522167|NCT00937326|144573945|SUPERIORITY|||||||0.999||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 1.0 g/day for change from Baseline in FPI on Day 28.||||0.999
72522168|NCT00937326|144573945|SUPERIORITY|||||||0.874||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 2.0 g/day for change from Baseline in FPI on Day 28.||||0.874
72522169|NCT00937326|144573945|SUPERIORITY|||||||0.986||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.25 g/day for change from Baseline in FPI on Day 35.||||0.986
72522170|NCT00937326|144573945|SUPERIORITY|||||||0.997||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.5 g/day for change from Baseline in FPI on Day 35.||||0.997
72522171|NCT00937326|144573945|SUPERIORITY|||||||1||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 1.0 g/day for change from Baseline in FPI on Day 35.||||1.000
72522172|NCT00937326|144573945|SUPERIORITY|||||||0.697||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 2.0 g/day for change from Baseline in FPI on Day 35.||||0.697
72522173|NCT00937326|144573946|SUPERIORITY|||||||1||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.25 g/day at 30 minutes for PPG.||||1.000
72522174|NCT00937326|144573946|SUPERIORITY|||||||0.812||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.5 g/day at 30 minutes for PPG.||||0.812
72522175|NCT00937326|144573946|SUPERIORITY|||||||0.996||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 1.0 g/day at 30 minutes for PPG.||||0.996
72522176|NCT00937326|144573946|SUPERIORITY|||||||0.198||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 2.0 g/day at 30 minutes for PPG.||||0.198
72522177|NCT00937326|144573946|SUPERIORITY|||||||1||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.25 g/day at 60 minutes for PPG.||||1.000
72522178|NCT00937326|144573946|SUPERIORITY|||||||0.358||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.5 g/day at 60 minutes for PPG.||||0.358
72522179|NCT00937326|144573946|SUPERIORITY|||||||0.852||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 1.0 g/day at 60 minutes for PPG.||||0.852
72522180|NCT00937326|144573946|SUPERIORITY|||||||0.678||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 2.0 g/day at 60 minutes for PPG.||||0.678
72522181|NCT00937326|144573946|SUPERIORITY|||||||1||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.25 g/day at 2 hour for PPG.||||1.000
72522182|NCT00937326|144573946|SUPERIORITY|||||||0.191||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.5 g/day at 2 hour for PPG.||||0.191
72570199|NCT02504671|144670135|OTHER||Difference|13.5|||||TWO_SIDED|95.0|0.5|26.5|||||Week 40, ACR70. Difference to Placebo for Week 40 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||26.5|0.5|
72522183|NCT00937326|144573946|SUPERIORITY|||||||0.805||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 1.0 g/day at 2 hour for PPG.||||0.805
72570200|NCT02504671|144670135|OTHER||Difference|10.8|||||TWO_SIDED|95.0|-1.4|23.0|||||Week 40, ACR70. Difference to Placebo for Week 40 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||23.0|-1.4|
72570201|NCT02504671|144670135|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-4.8|15.6|||||Week 44, ACR20. Difference to Placebo for Week 44 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||15.6|-4.8|
72570202|NCT02504671|144670135|OTHER||Difference|16.2|||||TWO_SIDED|95.0|2.6|29.9|||||Week 44, ACR20. Difference to Placebo for Week 44 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||29.9|2.6|
72570203|NCT02504671|144670135|OTHER||Difference|16.2|||||TWO_SIDED|95.0|2.6|29.9|||||Week 44, ACR20. Difference to Placebo for Week 44 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||29.9|2.6|
72570204|NCT02504671|144670135|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-4.8|15.6|||||Week 44, ACR50. Difference to Placebo for Week 44 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||15.6|-4.8|
72406082|NCT00653224|144320428|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.06||||0.258||95.0|-19.48|5.36||If the p-value of this estimated difference is lower than 5% the mean change from baseline in WPAI-AS score (dimension 6) is considered as different between the two treatment groups.|ANCOVA|ANCOVA on change from baseline in the WPAI:AS score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean change from baseline in WPAI-AS score (dimension 6) at week 1 is not different from subjects treated with levocetirizine than subjects treated with placebo.'||5.36|-19.48|0.258
72406083|NCT00653224|144320429|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.96||||0.288||95.0|-17.13|5.22||If the p-value of this estimated difference is lower than 5% the mean change from baseline in WPAI-AS score (dimension 6) is considered as different between the two treatment groups.|ANCOVA|ANCOVA on change from baseline in the WPAI:AS score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean change from baseline in WPAI-AS score (dimension 6) at week 2 is not different from subjects treated with levocetirizine than subjects treated with placebo.'||5.22|-17.13|0.288
72406084|NCT00653224|144320430|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.91|||<|0.001||95.0|-9.34|-2.47||If the p-value of this estimated difference is lower than 5% the mean change from baseline in WPAI-AS score (dimension 7) is considered as different between the two treatment groups.|ANCOVA|ANCOVA on change from baseline in the WPAI:AS score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean change from baseline in WPAI-AS score (dimension 7) at endpoint visit is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-2.47|-9.34|<0.001
72522184|NCT00937326|144573946|SUPERIORITY|||||||0.96||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 2.0 g/day at 2 hour for PPG.||||0.960
72522185|NCT00937326|144573946|SUPERIORITY|||||||0.985||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.25 g/day at 30 minutes for PPI.||||0.985
72522186|NCT00937326|144573946|SUPERIORITY|||||||0.733||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.5 g/day at 30 minutes for PPI.||||0.733
72522187|NCT00937326|144573946|SUPERIORITY|||||||0.365||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 1.0 g/day at 30 minutes for PPI.||||0.365
72522188|NCT00937326|144573946|SUPERIORITY|||||||0.413||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 2.0 g/day at 30 minutes for PPI.||||0.413
72522189|NCT00937326|144573946|SUPERIORITY|||||||0.765||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.25 g/day at 60 minutes for PPI.||||0.765
72522190|NCT00937326|144573946|SUPERIORITY|||||||0.434||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.5 g/day at 60 minutes for PPI.||||0.434
72522191|NCT00937326|144573946|SUPERIORITY|||||||0.184||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 1.0 g/day at 60 minutes for PPI.||||0.184
72522192|NCT00937326|144573946|SUPERIORITY|||||||0.142||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 2.0 g/day at 60 minutes for PPI.||||0.142
72522193|NCT00937326|144573946|SUPERIORITY|||||||0.999||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.25 g/day at 2 hour for PPI.||||0.999
72570205|NCT02504671|144670135|OTHER||Difference|16.2|||||TWO_SIDED|95.0|2.6|29.9|||||Week 44, ACR50. Difference to Placebo for Week 44 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||29.9|2.6|
72570206|NCT02504671|144670135|OTHER||Difference|13.5|||||TWO_SIDED|95.0|0.5|26.5|||||Week 44, ACR50. Difference to Placebo for Week 44 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||26.5|0.5|
72570207|NCT02504671|144670135|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||Week 44, ACR70. Difference to Placebo for Week 44 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
72406085|NCT00653224|144320431|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.62|||<|0.001||95.0|-9.88|-3.35||If the p-value of this estimated difference is lower than 5% the mean change from baseline in WPAI-AS score (dimension 7) is considered as different between the two treatment groups.|ANCOVA|ANCOVA on change from baseline in the WPAI:AS score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean change from baseline in WPAI-AS score (dimension 7) at week 1 is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-3.35|-9.88|<0.001
72522194|NCT00937326|144573946|SUPERIORITY|||||||0.876||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.5 g/day at 2 hour for PPI.||||0.876
72522195|NCT00937326|144573946|SUPERIORITY|||||||0.756||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 1.0 g/day at 2 hour for PPI.||||0.756
72522196|NCT00937326|144573946|SUPERIORITY|||||||0.983||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 2.0 g/day at 2 hour for PPI.||||0.983
72522197|NCT00937326|144573947|SUPERIORITY|||||||0.809||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.25 g/day for change from Baseline in PPG at 30 minutes.||||0.809
72522198|NCT00937326|144573947|SUPERIORITY|||||||1||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.5 g/day for change from Baseline in PPG at 30 minutes.||||1.000
72522199|NCT00937326|144573947|SUPERIORITY|||||||0.989||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 1.0 g/day for change from Baseline in PPG at 30 minutes.||||0.989
72522200|NCT00937326|144573947|SUPERIORITY|||||||0.13||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 2.0 g/day for change from Baseline in PPG at 30 minutes.||||0.130
72522201|NCT00937326|144573947|SUPERIORITY|||||||0.87||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.25 g/day for change from Baseline in PPG at 60 minutes.||||0.870
72522202|NCT00937326|144573947|SUPERIORITY|||||||0.864||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.5 g/day for change from Baseline in PPG at 60 minutes.||||0.864
72522203|NCT00937326|144573947|SUPERIORITY|||||||0.997||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 1.0 g/day for change from Baseline in PPG at 60 minutes.||||0.997
72522204|NCT00937326|144573947|SUPERIORITY|||||||0.682||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 2.0 g/day for change from Baseline in PPG at 60 minutes.||||0.682
72570208|NCT02504671|144670135|OTHER||Difference|18.9|||||TWO_SIDED|95.0|6.3|31.5|||||Week 44, ACR70. Difference to Placebo for Week 44 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||31.5|6.3|
72570209|NCT02504671|144670135|OTHER||Difference|10.8|||||TWO_SIDED|95.0|0.8|20.8|||||Week 44, ACR70. Difference to Placebo for Week 44 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||20.8|0.8|
72570210|NCT02504671|144670135|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-4.8|15.6|||||Week 48, ACR20. Difference to Placebo for Week 48 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||15.6|-4.8|
72570211|NCT02504671|144670135|OTHER||Difference|16.2|||||TWO_SIDED|95.0|2.6|29.9|||||Week 48, ACR20. Difference to Placebo for Week 48 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||29.9|2.6|
72570212|NCT02504671|144670135|OTHER||Difference|16.2|||||TWO_SIDED|95.0|2.6|29.9|||||Week 48, ACR20. Difference to Placebo for Week 48 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||29.9|2.6|
72570213|NCT02504671|144670135|OTHER||Difference|13.5|||||TWO_SIDED|95.0|0.5|26.5|||||Week 48, ACR50. Difference to Placebo for Week 48 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||26.5|0.5|
72522205|NCT00937326|144573947|SUPERIORITY|||||||0.798||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.25 g/day for change from Baseline in PPG at 2 hour.||||0.798
72570214|NCT02504671|144670135|OTHER||Difference|16.2|||||TWO_SIDED|95.0|2.6|29.9|||||Week 48, ACR50. Difference to Placebo for Week 48 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||29.9|2.6|
72522206|NCT00937326|144573947|SUPERIORITY|||||||0.73||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.5 g/day for change from Baseline in PPG at 2 hour.||||0.730
72522207|NCT00937326|144573947|SUPERIORITY|||||||1||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 1.0 g/day for change from Baseline in PPG at 2 hour.||||1.000
72522208|NCT00937326|144573947|SUPERIORITY|||||||1||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 2.0 g/day for change from Baseline in PPG at 2 hour.||||1.000
72522209|NCT00937326|144573947|SUPERIORITY|||||||0.464||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.25 g/day for change from Baseline in PPI at 30 minutes.||||0.464
72522210|NCT00937326|144573947|SUPERIORITY|||||||0.634||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.5 g/day for change from Baseline in PPI at 30 minutes.||||0.634
72522211|NCT00937326|144573947|SUPERIORITY|||||||0.254||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 1.0 g/day for change from Baseline in PPI at 30 minutes.||||0.254
72522212|NCT00937326|144573947|SUPERIORITY|||||||0.034||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 2.0 g/day for change from Baseline in PPI at 30 minutes.||||0.034
72570215|NCT02504671|144670135|OTHER||Difference|16.2|||||TWO_SIDED|95.0|2.6|29.9|||||Week 48, ACR50. Difference to Placebo for Week 48 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||29.9|2.6|
72570216|NCT02504671|144670135|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||Week 48, ACR70. Difference to Placebo for Week 48 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
72570217|NCT02504671|144670135|OTHER||Difference|18.9|||||TWO_SIDED|95.0|6.3|31.5|||||Week 48, ACR70. Difference to Placebo for Week 48 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||31.5|6.3|
72522213|NCT00937326|144573947|SUPERIORITY|||||||0.765||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.25 g/day for change from Baseline in PPI at 60 minutes.||||0.765
72570218|NCT02504671|144670135|OTHER||Difference|8.1|||||TWO_SIDED|95.0|-0.7|16.9|||||Week 48, ACR70. Difference to Placebo for Week 48 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||16.9|-0.7|
72570219|NCT02504671|144670135|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-4.8|15.6|||||Week 52, ACR20. Difference to Placebo for Week 52 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||15.6|-4.8|
72570220|NCT02504671|144670135|OTHER||Difference|13.5|||||TWO_SIDED|95.0|0.5|26.5|||||Week 52, ACR20. Difference to Placebo for Week 52 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||26.5|0.5|
72570221|NCT02504671|144670135|OTHER||Difference|13.5|||||TWO_SIDED|95.0|0.5|26.5|||||Week 52, ACR20. Difference to Placebo for Week 52 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||26.5|0.5|
72570222|NCT02504671|144670135|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-4.8|15.6|||||Week 52, ACR50. Difference to Placebo for Week 52 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||15.6|-4.8|
72570223|NCT02504671|144670135|OTHER||Difference|13.5|||||TWO_SIDED|95.0|0.5|26.5|||||Week 52, ACR50. Difference to Placebo for Week 52 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||26.5|0.5|
72570224|NCT02504671|144670135|OTHER||Difference|13.5|||||TWO_SIDED|95.0|0.5|26.5|||||Week 52, ACR50. Difference to Placebo for Week 52 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||26.5|0.5|
72570225|NCT02504671|144670135|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||Week 52, ACR70. Difference to Placebo for Week 52 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
72570226|NCT02504671|144670135|OTHER||Difference|16.2|||||TWO_SIDED|95.0|4.3|28.1|||||Week 52, ACR70. Difference to Placebo for Week 52 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||28.1|4.3|
72406086|NCT00653224|144320432|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.69||||0.001||95.0|-9.16|-2.21||If the p-value of this estimated difference is lower than 5% the mean change from baseline in WPAI-AS score (dimension 7) is considered as different between the two treatment groups.|ANCOVA|ANCOVA on change from baseline in the WPAI:AS score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean change from baseline in WPAI-AS score (dimension 7) at week 2 is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-2.21|-9.16|0.001
72522214|NCT00937326|144573947|SUPERIORITY|||||||0.434||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.5 g/day for change from Baseline in PPI at 60 minutes.||||0.434
72522215|NCT00937326|144573947|SUPERIORITY|||||||0.184||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 1.0 g/day for change from Baseline in PPI at 60 minutes.||||0.184
72522216|NCT00937326|144573947|SUPERIORITY|||||||0.142||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 2.0 g/day for change from Baseline in PPI at 60 minutes.||||0.142
72522217|NCT00937326|144573947|SUPERIORITY|||||||0.955||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.25 g/day for change from Baseline in PPI at 2 hour.||||0.955
72522218|NCT00937326|144573947|SUPERIORITY|||||||0.985||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.5 g/day for change from Baseline in PPI at 2 hour.||||0.985
72522219|NCT00937326|144573947|SUPERIORITY|||||||0.923||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 1.0 g/day for change from Baseline in PPI at 2 hour.||||0.923
72522220|NCT00937326|144573947|SUPERIORITY|||||||0.883||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 2.0 g/day for change from Baseline in PPI at 2 hour.||||0.883
72522221|NCT00937326|144573948|SUPERIORITY|||||||0.118||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||||||0.118
72522222|NCT00937326|144573948|SUPERIORITY|||||||0.119||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||||||0.119
72522223|NCT00937326|144573948|SUPERIORITY|||||||0.293||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||||||0.293
72522224|NCT00937326|144573948|SUPERIORITY|||||||0.966||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||||||0.966
72522225|NCT00937326|144573949|SUPERIORITY|||||||0.94||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||||||0.940
72522226|NCT00937326|144573949|SUPERIORITY|||||||0.197||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||||||0.197
72522227|NCT00937326|144573949|SUPERIORITY|||||||0.097||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||||||0.097
72522228|NCT00937326|144573949|SUPERIORITY|||||||0.404||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||||||0.404
72522229|NCT00937326|144573950|SUPERIORITY|||||||0.206||||||No adjustments for covariates were made.|Wilcoxon test|||Placebo versus SRT2104 0.25 g/day of AUC 0-1 at Day 1 for PPG.||||0.2060
72570227|NCT02504671|144670135|OTHER||Difference|10.8|||||TWO_SIDED|95.0|0.8|20.8|||||Week 52, ACR70. Difference to Placebo for Week 52 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||20.8|0.8|
72570228|NCT02504671|144670135|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-4.8|15.6|||||Week 62 (follow-up), ACR20. Difference to Placebo for Week 62 (follow-up) is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||15.6|-4.8|
72570229|NCT02504671|144670135|OTHER||Difference|13.5|||||TWO_SIDED|95.0|0.5|26.5|||||Week 62 (follow-up), ACR20. Difference to Placebo for Week 62 (follow-up) is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||26.5|0.5|
72522230|NCT00937326|144573950|SUPERIORITY|||||||0.179||||||No adjustments for covariates were made.|Wilcoxon test|||Placebo versus SRT2104 0.5 g/day of AUC 0-1 at Day 1 for PPG.||||0.1790
72570230|NCT02504671|144670135|OTHER||Difference|8.1|||||TWO_SIDED|95.0|-3.2|19.4|||||Week 62 (follow-up), ACR20. Difference to Placebo for Week 62 (follow-up) is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||19.4|-3.2|
72570231|NCT02504671|144670135|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-6.3|11.7|||||Week 62 (follow-up), ACR50. Difference to Placebo for Week 62 (follow-up) is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||11.7|-6.3|
72522231|NCT00937326|144573950|SUPERIORITY|||||||0.2741||||||No adjustments for covariates were made.|Wilcoxon test|||Placebo versus SRT2104 1.0 g/day of AUC 0-1 at Day 1 for PPG.||||0.2741
72522232|NCT00937326|144573950|SUPERIORITY|||||||0.6001||||||No adjustments for covariates were made.|Wilcoxon test|||Placebo versus SRT2104 2.0 g/day of AUC 0-1 at Day 1 for PPG.||||0.6001
72522233|NCT00937326|144573950|SUPERIORITY|||||||0.6711||||||No adjustments for covariates were made.|Wilcoxon test|||Placebo versus SRT2104 0.25 g/day of AUC 0-1 at Day 28 for PPG.||||0.6711
72570232|NCT02504671|144670135|OTHER||Difference|13.5|||||TWO_SIDED|95.0|0.5|26.5|||||Week 62 (follow-up), ACR50. Difference to Placebo for Week 62 (follow-up) is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||26.5|0.5|
72406087|NCT00653224|144320433|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.68||||0.027||95.0|-1.29|-0.08||If the p-value of this estimated difference is lower than 5% the mean change from baseline in ESS score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on change from baseline in ESS score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean change from baseline in ESS score at endpoint visit is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.08|-1.29|0.027
72570233|NCT02504671|144670135|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-4.8|15.6|||||Week 62 (follow-up), ACR50. Difference to Placebo for Week 62 (follow-up) is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||15.6|-4.8|
72570234|NCT02504671|144670135|OTHER||Difference|-2.7|||||TWO_SIDED|95.0|-7.9|2.5|||||Week 62 (follow-up), ACR70. Difference to Placebo for Week 62 (follow-up) is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||2.5|-7.9|
72570235|NCT02504671|144670135|OTHER||Difference|13.5|||||TWO_SIDED|95.0|0.5|26.5|||||Week 62 (follow-up), ACR70. Difference to Placebo for Week 62 (follow-up) is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||26.5|0.5|
72570236|NCT02504671|144670135|OTHER||Difference|0.0|||||TWO_SIDED|95.0|-7.4|7.4|||||Week 62 (follow-up), ACR70. Difference to Placebo for Week 62 (follow-up) is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.4|-7.4|
72522234|NCT00937326|144573950|OTHER|||||||0.1361||||||No adjustments for covariates were made.|Wilcoxon test|||Placebo versus SRT2104 0.5 g/day of AUC 0-1 at Day 28 for PPG.||||0.1361
72522235|NCT00937326|144573950|SUPERIORITY|||||||0.3369||||||No adjustments for covariates were made.|Wilcoxon test|||Placebo versus SRT2104 1.0 g/day of AUC 0-1 at Day 28 for PPG.||||0.3369
72522236|NCT00937326|144573950|SUPERIORITY|||||||0.0975||||||No adjustments for covariates were made.|Wilcoxon test|||Placebo versus SRT2104 2.0 g/day of AUC 0-1 at Day 28 for PPG.||||0.0975
72522237|NCT00937326|144573950|SUPERIORITY|||||||0.2184||||||No adjustments for covariates were made.|Wilcoxon test|||Placebo versus SRT2104 0.25 g/day of AUC 0-2 at Day 1 for PPG.||||0.2184
72522238|NCT00937326|144573950|SUPERIORITY|||||||0.1013||||||No adjustments for covariates were made.|Wilcoxon test|||Placebo versus SRT2104 0.5 g/day of AUC 0-2 at Day 1 for PPG.||||0.1013
72522239|NCT00937326|144573950|SUPERIORITY|||||||0.3286||||||No adjustments for covariates were made.|Wilcoxon test|||Placebo versus SRT2104 1.0 g/day of AUC 0-2 at Day 1 for PPG.||||0.3286
72522240|NCT00937326|144573950|SUPERIORITY|||||||0.5193||||||No adjustments for covariates were made.|Wilcoxon test|||Placebo versus SRT2104 2.0 g/day of AUC 0-2 at Day 1 for PPG.||||0.5193
72570237|NCT02504671|144670135|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||Week 1, ACR20. Difference to Placebo is presented for Week 1. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
72570238|NCT02504671|144670135|OTHER||Difference|18.9|||||TWO_SIDED|95.0|6.3|31.5|||||Week 1, ACR20. Difference to Placebo is presented for Week 1. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||31.5|6.3|
72570239|NCT02504671|144670135|OTHER||Difference|29.7|||||TWO_SIDED|95.0|12.7|46.8|||||Week 2, ACR20. Difference to Placebo is presented for Week 2. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||46.8|12.7|
72570240|NCT02504671|144670135|OTHER||Difference|37.8|||||TWO_SIDED|95.0|20.3|55.4|||||Week 2, ACR20. Difference to Placebo is presented for Week 2. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||55.4|20.3|
72570241|NCT02504671|144670135|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||Week 2, ACR50. Difference to Placebo is presented for Week 2. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
72570242|NCT02504671|144670135|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||Week 2, ACR50. Difference to Placebo is presented for Week 2. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
72570243|NCT02504671|144670135|OTHER||Difference|37.8|||||TWO_SIDED|95.0|19.5|56.1|||||Week 4, ACR20. Difference to Placebo is presented for Week 4. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||56.1|19.5|
72625051|NCT04380142|144779729|SUPERIORITY||LS Mean of Difference|-5.4|STANDARD_ERROR_OF_MEAN|1.32|<=|0.001|TWO_SIDED|95.0|-8.03|-2.78||ANCOVA model including effects for treatment, country, and baseline.|ANCOVA|||||-2.78|-8.03|<=0.001
72625052|NCT04380142|144779730|SUPERIORITY||Least Squares (LS) Mean of Difference|-4.1|STANDARD_ERROR_OF_MEAN|2.04||0.047|TWO_SIDED|95.0|-8.14|-0.05||ANCOVA model including effects for treatment, country, and baseline.|ANCOVA|||||-0.05|-8.14|0.0470
72625053|NCT04380142|144779731|SUPERIORITY||LS Mean of Difference|0.049|STANDARD_ERROR_OF_MEAN|0.025||0.0566|TWO_SIDED|95.0|-0.001|0.1||ANCOVA model including effects for treatment, country, and baseline.|ANCOVA|||||0.100|-0.001|0.0566
72625054|NCT04380142|144779732|SUPERIORITY||LS Mean of Difference|1.72|STANDARD_ERROR_OF_MEAN|0.72||0.0184|TWO_SIDED|95.0|0.3|3.15||The model included fixed categorical effects of treatment, country and visit, baseline-by-visit and treatment-by-visit interactions, and baseline as a covariate. An unstructured variance-covariance matrix was used.|Repeated measures model|||||3.15|0.30|0.0184
72522241|NCT00937326|144573950|SUPERIORITY|||||||0.9788||||||No adjustments for covariates were made.|Wilcoxon test|||Placebo versus SRT2104 0.25 g/day of AUC 0-2 at Day 28 for PPG.||||0.9788
72522242|NCT00937326|144573950|SUPERIORITY|||||||0.1214||||||No adjustments for covariates were made.|Wilcoxon test|||Placebo versus SRT2104 0.5 g/day of AUC 0-2 at Day 28 for PPG.||||0.1214
72522243|NCT00937326|144573950|SUPERIORITY|||||||0.5751||||||No adjustments for covariates were made.|Wilcoxon test|||Placebo versus SRT2104 1.0 g/day of AUC 0-2 at Day 28 for PPG.||||0.5751
72522244|NCT00937326|144573950|SUPERIORITY|||||||0.2409||||||No adjustments for covariates were made.|Wilcoxon test|||Placebo versus SRT2104 2.0 g/day of AUC 0-2 at Day 28 for PPG.||||0.2409
72522245|NCT00937326|144573950|SUPERIORITY|||||||0.4829||||||No adjustments for covariates were made.|Wilcoxon test|||Placebo versus SRT2104 0.25 g/day of AUC 0-1 at Day 1 for PPI.||||0.4829
72522246|NCT00937326|144573950|SUPERIORITY|||||||0.7563||||||No adjustments for covariates were made.|Wilcoxon test|||Placebo versus SRT2104 0.5 g/day of AUC 0-1 at Day 1 for PPI.||||0.7563
72522247|NCT00937326|144573950|SUPERIORITY|||||||0.2907||||||No adjustments for covariates were made.|Wilcoxon test|||Placebo versus SRT2104 1.0 g/day of AUC 0-1 at Day 1 for PPI.||||0.2907
72522248|NCT00937326|144573950|SUPERIORITY|||||||0.7663||||||No adjustments for covariates were made.|Wilcoxon test|||Placebo versus SRT2104 2.0 g/day of AUC 0-1 at Day 1 for PPI.||||0.7663
72522249|NCT00937326|144573950|SUPERIORITY|||||||0.5825||||||No adjustments for covariates were made.|Wilcoxon test|||Placebo versus SRT2104 0.25 g/day of AUC 0-1 at Day 28 for PPI||||0.5825
72522250|NCT00937326|144573950|SUPERIORITY|||||||0.322||||||No adjustments for covariates were made.|Wilcoxon test|||Placebo versus SRT2104 0.5 g/day of AUC 0-1 at Day 28 for PPI.||||0.3220
72522251|NCT00937326|144573950|SUPERIORITY|||||||0.0564||||||No adjustments for covariates were made.|Wilcoxon test|||Placebo versus SRT2104 1.0 g/day of AUC 0-1 at Day 28 for PPI.||||0.0564
72522252|NCT00937326|144573950|SUPERIORITY|||||||0.196||||||No adjustments for covariates were made.|Wilcoxon test|||Placebo versus SRT2104 0.25 g/day of AUC 0-1 at Day 28 for PPI.||||0.1960
72522253|NCT00937326|144573950|SUPERIORITY|||||||0.5997||||||No adjustments for covariates were made.|Wilcoxon test|||Placebo versus SRT2104 0.25 g/day of AUC 0-2 at Day 1 for PPI.||||0.5997
72522254|NCT00937326|144573950|SUPERIORITY|||||||0.9637||||||No adjustments for covariates were made.|Wilcoxon test|||Placebo versus SRT2104 0.5 g/day of AUC 0-2 at Day 1 for PPI.||||0.9637
72522255|NCT00937326|144573950|SUPERIORITY|||||||0.324||||||No adjustments for covariates were made.|Wilcoxon test|||Placebo versus SRT2104 1.0 g/day of AUC 0-2 at Day 1 for PPI.||||0.3240
72522256|NCT00937326|144573950|SUPERIORITY|||||||0.844||||||No adjustments for covariates were made.|Wilcoxon test|||Placebo versus SRT2104 2.0 g/day of AUC 0-2 at Day 1 for PPI.||||0.8440
72522257|NCT00937326|144573950|SUPERIORITY|||||||0.6483||||||No adjustments for covariates were made.|Wilcoxon test|||Placebo versus SRT2104 0.25 g/day of AUC 0-2 at Day 28 for PPI.||||0.6483
72522258|NCT00937326|144573950|SUPERIORITY|||||||0.6452||||||No adjustments for covariates were made.|Wilcoxon test|||Placebo versus SRT2104 0.5 g/day of AUC 0-2 at Day 28 for PPI.||||0.6452
72522259|NCT00937326|144573950|SUPERIORITY|||||||0.1253||||||No adjustments for covariates were made.|Wilcoxon test|||Placebo versus SRT2104 1.0 g/day of AUC 0-2 at Day 28 for PPI.||||0.1253
72522260|NCT00937326|144573950|SUPERIORITY|||||||0.2583||||||No adjustments for covariates were made.|Wilcoxon test|||Placebo versus SRT2104 2.0 g/day of AUC 0-2 at Day 28 for PPI.||||0.2583
72522261|NCT00937326|144573951|SUPERIORITY|||||||1||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.25 g/day at Day 1 for fructosamine.||||1.000
72522262|NCT00937326|144573951|SUPERIORITY|||||||1||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.5 g/day at Day 1 for fructosamine.||||1.000
72522263|NCT00937326|144573951|SUPERIORITY|||||||0.901||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 1.0 g/day at Day 1 for fructosamine.||||0.901
72522264|NCT00937326|144573951|SUPERIORITY|||||||0.155||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 2.0 g/day at Day 1 for fructosamine.||||0.155
72522265|NCT00937326|144573951|SUPERIORITY|||||||0.845||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.25 g/day at Day 28 for fructosamine.||||0.845
72522266|NCT00937326|144573951|SUPERIORITY|||||||0.164||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.5 g/day at Day 28 for fructosamine.||||0.164
72625055|NCT04380142|144779733|SUPERIORITY||LS Mean of Difference|0.18|STANDARD_ERROR_OF_MEAN|0.69||0.7989|TWO_SIDED|95.0|-1.2|1.55||The model included fixed categorical effects of treatment, country and visit, baseline-by-visit and treatment-by-visit interactions, and baseline as a covariate. An unstructured variance-covariance matrix was used.|Repeated measures model|||||1.55|-1.20|0.7989
72522267|NCT00937326|144573951|SUPERIORITY|||||||0.699||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 1.0 g/day at Day 28 for fructosamine.||||0.699
72522268|NCT00937326|144573951|SUPERIORITY|||||||0.313||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 2.0 g/day at Day 28 for fructosamine.||||0.313
72522269|NCT00937326|144573952|SUPERIORITY|||||||0.896||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||||||0.896
72522270|NCT00937326|144573952|SUPERIORITY|||||||0.08||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||||||0.080
72522271|NCT00937326|144573952|SUPERIORITY|||||||0.792||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||||||0.792
72522272|NCT00937326|144573952|SUPERIORITY|||||||0.645||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||||||0.645
72522273|NCT00937326|144573953|SUPERIORITY|||||||0.992||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.25 g/day at Day 1 for HOMA-IR.||||0.992
72522274|NCT00937326|144573953|SUPERIORITY|||||||0.999||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.5 g/day at Day 1 for HOMA-IR.||||0.999
72522275|NCT00937326|144573953|SUPERIORITY|||||||0.548||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 1.0 g/day at Day 1 for HOMA-IR.||||0.548
72522276|NCT00937326|144573953|SUPERIORITY|||||||0.989||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 2.0 g/day at Day 1 for HOMA-IR.||||0.989
72522277|NCT00937326|144573953|SUPERIORITY|||||||0.877||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.25 g/day at Day 28 for HOMA-IR.||||0.877
72522278|NCT00937326|144573953|SUPERIORITY|||||||0.887||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.5 g/day at Day 28 for HOMA-IR.||||0.887
72522279|NCT00937326|144573953|SUPERIORITY|||||||0.916||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 1.0 g/day at Day 28 for HOMA-IR.||||0.916
72522280|NCT00937326|144573953|SUPERIORITY|||||||0.86||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 2.0 g/day at Day 28 for HOMA-IR.||||0.860
72625056|NCT04380142|144779734|SUPERIORITY||LS Mean of Difference|-2.73|STANDARD_ERROR_OF_MEAN|1.96||0.1656|TWO_SIDED|95.0|-6.61|1.15||The model included fixed categorical effects of treatment, country and visit, baseline-by-visit and treatment-by-visit interactions, and baseline as a covariate. An unstructured variance-covariance matrix was used.|Repeated measures model|||||1.15|-6.61|0.1656
72625057|NCT04380142|144779735|SUPERIORITY||LS Mean of Difference|-5.49|STANDARD_ERROR_OF_MEAN|3.65||0.1347|TWO_SIDED|95.0|-12.71|1.73||The model included fixed categorical effects of treatment, country and visit, baseline-by-visit and treatment-by-visit interactions, and baseline as a covariate. An unstructured variance-covariance matrix was used.|Repeated measures model|||||1.73|-12.71|0.1347
72522281|NCT00937326|144573954|SUPERIORITY|||||||0.996||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||||||0.996
72522282|NCT00937326|144573954|SUPERIORITY|||||||0.989||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||||||0.989
72522283|NCT00937326|144573954|SUPERIORITY|||||||0.999||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||||||0.999
72522284|NCT00937326|144573954|SUPERIORITY|||||||0.763||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||||||0.763
72522285|NCT00937326|144573955|SUPERIORITY|||||||0.81||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.25 g/day at Day 1 for HOMA-percentage of beta cell function.||||0.810
72522286|NCT00937326|144573955|SUPERIORITY|||||||0.753||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.5 g/day at Day 1 for HOMA-percentage of beta cell function.||||0.753
72522287|NCT00937326|144573955|SUPERIORITY|||||||0.404||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 1.0 g/day at Day 1 for HOMA-percentage of beta cell function.||||0.404
72522288|NCT00937326|144573955|SUPERIORITY|||||||0.671||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 2.0 g/day at Day 1 for HOMA-percentage of beta cell function.||||0.671
72522289|NCT00937326|144573955|SUPERIORITY|||||||1||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.25 g/day at Day 28 for HOMA-percentage of beta cell function.||||1.000
72522290|NCT00937326|144573955|SUPERIORITY|||||||0.622||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.5 g/day at Day 28 for HOMA-percentage of beta cell function.||||0.622
72522291|NCT00937326|144573955|SUPERIORITY|||||||0.332||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 1.0 g/day at Day 28 for HOMA-percentage of beta cell function.||||0.332
72522292|NCT00937326|144573955|SUPERIORITY|||||||0.998||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 2.0 g/day at Day 28 for HOMA-percentage of beta cell function.||||0.998
72522293|NCT00937326|144573956|SUPERIORITY|||||||0.994||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||||||0.994
72522294|NCT00937326|144573956|SUPERIORITY|||||||0.979||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||||||0.979
72522295|NCT00937326|144573956|SUPERIORITY|||||||0.993||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||||||0.993
72625058|NCT02908178|144779742|OTHER||Odds Ratio (OR)|1.39|||<|0.001|TWO_SIDED|99.0|1.18|1.63||P-value is unadjusted. Threshold for statistical significance is 0.01.|Chi-squared||Reference is no SLNB. Odds ratio accounts for matching and adjusted for subsequent mastectomy within 180 days after initial BCS, prior MRI, and radiation therapy status.|Testing the association between use of sentinel lymph node biopsy (SLNB) and any complication in the Aim 1 matched cohort.||1.63|1.18|<.001
72570244|NCT02504671|144670135|OTHER||Difference|51.4|||||TWO_SIDED|95.0|19.5|56.1|||||Week 4, ACR20. Difference to Placebo is presented for Week 4. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||56.1|19.5|
72522296|NCT00937326|144573956|SUPERIORITY|||||||0.999||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||||||0.999
72522297|NCT02853123|144573985|SUPERIORITY||Mean Difference (Final Values)|-0.357|STANDARD_ERROR_OF_MEAN|0.153||0.0217|TWO_SIDED|95.0|-0.661|-0.053|||Mixed Effect Model Repeated Measures|Kenward-Roger approximation of denominator was used for degrees of freedom.|Mean difference means the treatment difference vs. Tiotropium (i.e. Tiotropium/Olodaterol - Tiotropium).|The adjusted means (SE) are obtained from fitting an Mixed-effects Model Repeated Measures (MMRM) model including treatment and period as fixed effects, patient as a random effect, and period baseline and patient baseline as covariates, compound symmetry covariance structure for within-patient variation.||-0.053|-0.661|0.0217
72522298|NCT02853123|144573986|SUPERIORITY||Mean Difference (Final Values)|0.185|STANDARD_ERROR_OF_MEAN|0.04|<|0.0001|TWO_SIDED|95.0|0.106|0.265|||Mixed Effect Model Repeated Measures|Kenward-Roger approximation of denominator was used for degrees of freedom.|Mean difference means the treatment difference vs. Tiotropium (i.e. Tiotropium/Olodaterol - Tiotropium).|IC measured prior to exercise, the adjusted means (SE) are obtained from fitting an Mixed-effects Model Repeated Measures (MMRM) model including treatment and period as fixed effects, patient as a random effect, and period baseline and patient baseline as covariates, compound symmetry covariance structure for within-patient variation.||0.265|0.106|<.0001
72522299|NCT02853123|144573987|SUPERIORITY||Mean Difference (Final Values)|0.066|STANDARD_ERROR_OF_MEAN|0.038||0.0852|TWO_SIDED|95.0|-0.009|0.141|||Mixed Effect Model Repeated Measures|Kenward-Roger approximation of denominator was used for degrees of freedom.|Mean difference means the treatment difference vs. Tiotropium (i.e. Tiotropium/Olodaterol - Tiotropium).|IC measured end of exercise, the adjusted means (SE) are obtained from fitting an Mixed-effects Model Repeated Measures (MMRM) model including treatment and period as fixed effects, patient as a random effect, and period baseline and patient baseline as covariates, compound symmetry covariance structure for within-patient variation.||0.141|-0.009|0.0852
72522300|NCT02853123|144573988|SUPERIORITY||Mean Difference (Final Values)|0.155|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001|TWO_SIDED|95.0|0.117|0.194|||Mixed Effect Model Repeated Measures|Kenward-Roger approximation of denominator was used for degrees of freedom.|Mean difference means the treatment difference vs. Tiotropium (i.e. Tiotropium/Olodaterol - Tiotropium).|The adjusted means (SE) are obtained from fitting an Mixed-effects Model Repeated Measures (MMRM) model including treatment and period as fixed effects, patient as a random effect, and period baseline and patient baseline as covariates, compound symmetry covariance structure for within-patient variation.||0.194|0.117|<.0001
72522301|NCT02853123|144573989|SUPERIORITY||Mean Difference (Final Values)|0.201|STANDARD_ERROR_OF_MEAN|0.034|<|0.0001|TWO_SIDED|95.0|0.134|0.267|||Mixed Effect Model Repeated Measures|Kenward-Roger approximation of denominator was used for degrees of freedom.|Mean difference means the treatment difference vs. Tiotropium (i.e. Tiotropium/Olodaterol - Tiotropium).|The adjusted means (SE) are obtained from fitting an Mixed-effects Model Repeated Measures (MMRM) model including treatment and period as fixed effects, patient as a random effect, and period baseline and patient baseline as covariates, compound symmetry covariance structure for within-patient variation.||0.267|0.134|<.0001
72522302|NCT02853123|144573990|SUPERIORITY||Mean Difference (Final Values)|-0.108|STANDARD_ERROR_OF_MEAN|0.096||0.2645|TWO_SIDED|95.0|-0.3|0.083|||Mixed Effect Model Repeated Measures|Kenward-Roger approximation of denominator was used for degrees of freedom.|Mean difference means the treatment difference vs. Tiotropium (i.e. Tiotropium/Olodaterol - Tiotropium).|1 min, the adjusted means (SE) are obtained from fitting an Mixed-effects Model Repeated Measures (MMRM) model including treatment and period as fixed effects, patient as a random effect, and period baseline and patient baseline as covariates, compound symmetry covariance structure for within-patient variation.||0.083|-0.300|0.2645
72522303|NCT02853123|144573990|SUPERIORITY||Mean Difference (Final Values)|-0.24|STANDARD_ERROR_OF_MEAN|0.107||0.0267|TWO_SIDED|95.0|-0.452|-0.028|||Mixed Effect Model Repeated Measures|Kenward-Roger approximation of denominator was used for degrees of freedom.|Mean difference means the treatment difference vs. Tiotropium (i.e. Tiotropium/Olodaterol - Tiotropium).|2 min, the adjusted means (SE) are obtained from fitting an Mixed-effects Model Repeated Measures (MMRM) model including treatment and period as fixed effects, patient as a random effect, and period baseline and patient baseline as covariates, compound symmetry covariance structure for within-patient variation.||-0.028|-0.452|0.0267
72522304|NCT02853123|144573990|SUPERIORITY||Mean Difference (Final Values)|-0.318|STANDARD_ERROR_OF_MEAN|0.14||0.0258|TWO_SIDED|95.0|-0.596|-0.039|||Mixed Effect Model Repeated Measures|Kenward-Roger approximation of denominator was used for degrees of freedom.|Mean difference means the treatment difference vs. Tiotropium (i.e. Tiotropium/Olodaterol - Tiotropium).|2.5 min, the adjusted means (SE) are obtained from fitting an Mixed-effects Model Repeated Measures (MMRM) model including treatment and period as fixed effects, patient as a random effect, and period baseline and patient baseline as covariates, compound symmetry covariance structure for within-patient variation.||-0.039|-0.596|0.0258
72570245|NCT02504671|144670135|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-8.7|14.1|||||Week 4, ACR50. Difference to Placebo is presented for Week 4. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||14.1|-8.7|
72570246|NCT02504671|144670135|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-8.7|14.1|||||Week 4, ACR50. Difference to Placebo is presented for Week 4. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||14.1|-8.7|
72570247|NCT02504671|144670135|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||Week 4, ACR70. Difference to Placebo is presented for Week 4. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
72570248|NCT02504671|144670135|OTHER||Difference|13.5|||||TWO_SIDED|95.0|-6.8|33.8|||||Week 6, ACR20. Difference to Placebo is presented for Week 6. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||33.8|-6.8|
72570249|NCT02504671|144670135|OTHER||Difference|24.3|||||TWO_SIDED|95.0|3.5|45.2|||||Week 6, ACR20. Difference to Placebo is presented for Week 6. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||45.2|3.5|
72522305|NCT02853123|144573991|SUPERIORITY||Mean Difference (Final Values)|-0.03|STANDARD_ERROR_OF_MEAN|0.12||0.8025|TWO_SIDED|95.0|-0.268|0.208|||Mixed Effect Model Repeated Measures|Kenward-Roger approximation of denominator was used for degrees of freedom.|Mean difference means the treatment difference vs. Tiotropium (i.e. Tiotropium/Olodaterol - Tiotropium).|The adjusted means (SE) are obtained from fitting an Mixed-effects Model Repeated Measures (MMRM) model including treatment and period as fixed effects, patient as a random effect, and period baseline and patient baseline as covariates, compound symmetry covariance structure for within-patient variation.||0.208|-0.268|0.8025
72522306|NCT02853123|144573992|SUPERIORITY||Mean Difference (Final Values)|0.09|STANDARD_ERROR_OF_MEAN|0.099||0.3634|TWO_SIDED|95.0|-0.106|0.286|||Mixed Effect Model Repeated Measures|Kenward-Roger approximation of denominator was used for degrees of freedom.|Mean difference means the treatment difference vs. Tiotropium (i.e. Tiotropium/Olodaterol - Tiotropium).|The adjusted means (SE) are obtained from fitting an Mixed-effects Model Repeated Measures (MMRM) model including treatment and period as fixed effects, patient as a random effect, and period baseline and patient baseline as covariates, compound symmetry covariance structure for within-patient variation.||0.286|-0.106|0.3634
72522307|NCT05516134|144574005|SUPERIORITY||||||<|0.01|||||||t-test, 2 sided|||baseline vs. treatment, paired sample t-test||||<0.01
72522308|NCT05516134|144574006|SUPERIORITY||||||<|0.01|||||||t-test, 2 sided|||||||<.01
72522309|NCT05516134|144574007|SUPERIORITY||||||<|0.01|||||||t-test, 2 sided|||||||<.01
72522310|NCT05516134|144574008|SUPERIORITY|||||||0.03|||||||t-test, 2 sided|||||||.03
72522311|NCT05516134|144574009|SUPERIORITY||||||<|0.01|||||||t-test, 2 sided|||||||<.01
72522312|NCT05516134|144574010|SUPERIORITY|||||||0.11|||||||t-test, 2 sided|||||||.11
72522313|NCT05516134|144574011|SUPERIORITY||||||<|0.01|||||||t-test, 2 sided|||||||<.01
72522314|NCT05516134|144574012|SUPERIORITY|||||||0.09|||||||t-test, 2 sided|||||||0.09
72522315|NCT01094808|144574110|SUPERIORITY_OR_OTHER||mean value for 200 mg Pregabalin|33.391|STANDARD_DEVIATION|22.106||0.14||95.0||||P-value not adjusted for multiple comparisons; alpha level of 0.05 used|ANCOVA||A confidence interval was not calculated|ANCOVA for overall treatment effects||||0.14
72522316|NCT01094808|144574111|SUPERIORITY_OR_OTHER||mean value for 200 mg Pregabalin|35.301|STANDARD_DEVIATION|22.295||0.12||95.0||||P-value not adjusted for multiple comparisons; alpha level of 0.05 used|ANCOVA||A confidence interval was not calculated|ANCOVA for overall treatment effects||||0.12
72522317|NCT02019758|144574120|SUPERIORITY|||||||0.31|||||||t-test, 2 sided|||The mean post-treatment maximum eosinophil count will be compared between the OVB and MDI groups using a two-sample t-test.||||0.31
72522318|NCT02019758|144574121|SUPERIORITY|||||||0.7|||||||t-test, 2 sided|||The mean DSQ scores will be compared between the OVB and MDI groups using a two-sample t-test.||||0.70
72522319|NCT02019758|144574126|SUPERIORITY||Hazard Ratio (HR)|1.04|||||TWO_SIDED|95.0|0.52|2.08||||||||2.08|0.52|
72522320|NCT02019758|144574127|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
72570250|NCT02504671|144670135|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-12.2|17.6|||||Week 6, ACR50. Difference to Placebo is presented for Week 6. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||17.6|-12.2|
72522321|NCT02019758|144574128|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
72522322|NCT02019758|144574129|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
72522323|NCT01156363|144574162|SUPERIORITY_OR_OTHER|||||||0.9825|TWO_SIDED||||||Paired t-test|||Change from baseline to Month 1: analysis was performed using paired t-test.||||0.9825
72522324|NCT01156363|144574162|SUPERIORITY_OR_OTHER|||||||0.5737|TWO_SIDED||||||Paired t-test|||Change from baseline to Month 1: analysis was performed using paired t-test.||||0.5737
72522325|NCT01156363|144574162|SUPERIORITY_OR_OTHER|||||||0.5703|TWO_SIDED||||||Paired t-test|||Change from baseline to Month 1: analysis was performed using paired t-test.||||0.5703
72522326|NCT01156363|144574162|SUPERIORITY_OR_OTHER|||||||0.5684|TWO_SIDED||||||Paired t-test|||Change from baseline to Month 1: analysis was performed using paired t-test.||||0.5684
72522327|NCT01156363|144574162|SUPERIORITY_OR_OTHER|||||||0.8235|TWO_SIDED||||||Paired t-test|||Change from baseline to Month 2: analysis was performed using paired t-test.||||0.8235
72522328|NCT01156363|144574162|SUPERIORITY_OR_OTHER|||||||0.2384|TWO_SIDED||||||Paired t-test|||Change from baseline to Month 2: analysis was performed using paired t-test.||||0.2384
72522329|NCT01156363|144574162|SUPERIORITY_OR_OTHER|||||||0.1634|TWO_SIDED||||||Paired t-test|||Change from baseline to Month 2: analysis was performed using paired t-test.||||0.1634
72522330|NCT01156363|144574162|SUPERIORITY_OR_OTHER|||||||0.7816|TWO_SIDED||||||Paired t-test|||Change from baseline to Month 2: analysis was performed using paired t-test.||||0.7816
72522331|NCT01156363|144574162|SUPERIORITY_OR_OTHER|||||||0.3917|TWO_SIDED||||||Paired t-test|||Change from baseline to Month 3: analysis was performed using paired t-test.||||0.3917
72522332|NCT01156363|144574162|SUPERIORITY_OR_OTHER|||||||0.1749|TWO_SIDED||||||Paired t-test|||Change from baseline to Month 3: analysis was performed using paired t-test.||||0.1749
72522333|NCT01156363|144574162|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Paired t-test|||Change from baseline to Month 3: analysis was performed using paired t-test.||||<0.001
72522334|NCT01156363|144574162|SUPERIORITY_OR_OTHER|||||||0.0905|TWO_SIDED||||||Paired t-test|||Change from baseline to Month 3: analysis was performed using paired t-test.||||0.0905
72522335|NCT01156363|144574162|SUPERIORITY_OR_OTHER|||||||0.3766|TWO_SIDED||||||Paired t-test|||Change from baseline to Month 4: analysis was performed using paired t-test.||||0.3766
72522336|NCT01156363|144574162|SUPERIORITY_OR_OTHER|||||||0.0253|TWO_SIDED||||||Paired t-test|||Change from baseline to Month 4: analysis was performed using paired t-test.||||0.0253
72522337|NCT01156363|144574162|SUPERIORITY_OR_OTHER|||||||0.0209|TWO_SIDED||||||Paired t-test|||Change from baseline to Month 4: analysis was performed using paired t-test.||||0.0209
72522338|NCT01156363|144574162|SUPERIORITY_OR_OTHER|||||||0.8206|TWO_SIDED||||||Paired t-test|||Change from baseline to Month 4: analysis was performed using paired t-test.||||0.8206
72522339|NCT01156363|144574162|SUPERIORITY_OR_OTHER|||||||0.0907|TWO_SIDED||||||Paired t-test|||Change from baseline to Month 5: analysis was performed using paired t-test.||||0.0907
72570251|NCT02504671|144670135|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-12.2|17.6|||||Week 6, ACR50. Difference to Placebo is presented for Week 6. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||17.6|-12.2|
72522340|NCT01156363|144574162|SUPERIORITY_OR_OTHER|||||||0.0177|TWO_SIDED||||||Paired t-test|||Change from baseline to Month 5: analysis was performed using paired t-test.||||0.0177
72522341|NCT01156363|144574162|SUPERIORITY_OR_OTHER|||||||0.005|TWO_SIDED||||||Paired t-test|||Change from baseline to Month 5: analysis was performed using paired t-test.||||0.0050
72522342|NCT01156363|144574162|SUPERIORITY_OR_OTHER|||||||0.3724|TWO_SIDED||||||Paired t-test|||Change from baseline to Month 5: analysis was performed using paired t-test.||||0.3724
72522343|NCT01156363|144574162|SUPERIORITY_OR_OTHER|||||||0.2796|TWO_SIDED||||||Paired t-test|||Change from baseline to Month 6: analysis was performed using paired t-test.||||0.2796
72522344|NCT01156363|144574162|SUPERIORITY_OR_OTHER|||||||0.0066|TWO_SIDED||||||Paired t-test|||Change from baseline to Month 6: analysis was performed using paired t-test.||||0.0066
72522345|NCT01156363|144574162|SUPERIORITY_OR_OTHER|||||||0.0081|TWO_SIDED||||||Paired t-test|||Change from baseline to Month 6: analysis was performed using paired t-test.||||0.0081
72522346|NCT01156363|144574162|SUPERIORITY_OR_OTHER|||||||0.7853|TWO_SIDED||||||Paired t-test|||Change from baseline to Month 6: analysis was performed using paired t-test.||||0.7853
72522347|NCT01156363|144574162|SUPERIORITY_OR_OTHER|||||||0.0039|TWO_SIDED||||||Paired t-test|||Change from baseline to Month 7: analysis was performed using paired t-test.||||0.0039
72522348|NCT01156363|144574162|SUPERIORITY_OR_OTHER|||||||0.3057|TWO_SIDED||||||Paired t-test|||Change from baseline to Month 7: analysis was performed using paired t-test.||||0.3057
72522349|NCT01156363|144574162|SUPERIORITY_OR_OTHER|||||||0.3374|TWO_SIDED||||||Paired t-test|||Change from baseline to Month 7: analysis was performed using paired t-test.||||0.3374
72522350|NCT01156363|144574162|SUPERIORITY_OR_OTHER|||||||0.141|TWO_SIDED||||||Paired t-test|||Change from baseline to Month 7: analysis was performed using paired t-test.||||0.1410
72522351|NCT01156363|144574162|SUPERIORITY_OR_OTHER|||||||0.0017|TWO_SIDED||||||Paired t-test|||Change from baseline to Month 8: analysis was performed using paired t-test.||||0.0017
72522352|NCT01156363|144574162|SUPERIORITY_OR_OTHER|||||||0.0677|TWO_SIDED||||||Paired t-test|||Change from baseline to Month 8: analysis was performed using paired t-test.||||0.0677
72522353|NCT01156363|144574162|SUPERIORITY_OR_OTHER|||||||0.1608|TWO_SIDED||||||Paired t-test|||Change from baseline to Month 8: analysis was performed using paired t-test.||||0.1608
72522354|NCT01156363|144574162|SUPERIORITY_OR_OTHER|||||||0.0196|TWO_SIDED||||||Paired t-test|||Change from baseline to Month 8: analysis was performed using paired t-test.||||0.0196
72522355|NCT04882072|144574165|SUPERIORITY||Hazard Ratio (HR)|1.86|||||TWO_SIDED|95.0|0.41|8.47||||||||8.47|0.41|
72522356|NCT02918318|144574186|SUPERIORITY||Difference of Least Squares means|-1.0|STANDARD_ERROR_OF_MEAN|2.25||0.475|TWO_SIDED|90.0|-5.77|3.7||1-sided|Dunnett adjustment|||||3.70|-5.77|0.475
72522357|NCT02918318|144574186|SUPERIORITY||Difference of Least Squares means|0.6|STANDARD_ERROR_OF_MEAN|2.33||0.504|TWO_SIDED|90.0|-4.32|5.47||1-sided|Dunnett adjustment|||||5.47|-4.32|0.504
72522358|NCT02918318|144574186|SUPERIORITY||Difference of Least Squares means|-0.9|STANDARD_ERROR_OF_MEAN|2.26||0.482|TWO_SIDED|90.0|-5.66|3.83||1-sided|Dunnett adjustment|||||3.83|-5.66|0.482
72522359|NCT00356057|144574224|SUPERIORITY|||||||0.437|||||||t-test, 2 sided|||||||0.437
72522360|NCT00356057|144574224|SUPERIORITY|||||||0.405|||||||t-test, 2 sided|||||||0.405
72522361|NCT00356057|144574225|EQUIVALENCE|Complication-free rate was evaluated in an equivalence (non-inferiority) format compared to a target of 85% minus delta (10%), where delta is the clinically significant difference for establishing equivalence.||||||0.0596|||||||t-test, 1 sided|||||||0.0596
72522362|NCT00356057|144574226|EQUIVALENCE|Complication-free rate was evaluated in an equivalence (non-inferiority) format compared to a target of 85% minus delta (10%), where delta is the clinically significant difference for establishing equivalence.||||||0.0009|||||||t-test, 1 sided|||||||0.0009
72522363|NCT00356057|144574229|SUPERIORITY|||||||0.03|||||||t-test, 2 sided|||||||0.030
72522364|NCT00356057|144574229|SUPERIORITY|||||||0.006|||||||t-test, 2 sided|||||||0.006
72522365|NCT00356057|144574233|SUPERIORITY|||||||0.005|||||||t-test, 2 sided|||||||0.005
72570252|NCT02504671|144670135|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||Week 6, ACR70. Difference to Placebo is presented for Week 6. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
72522366|NCT00356057|144574233|SUPERIORITY|||||||0.014|||||||t-test, 2 sided|||||||0.014
72522367|NCT00356057|144574234|SUPERIORITY|||||||0.02|||||||t-test, 2 sided|||||||0.020
72522368|NCT00356057|144574234|SUPERIORITY|||||||0.008|||||||t-test, 2 sided|||||||0.008
72522369|NCT00356057|144574235|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
72522370|NCT00356057|144574235|SUPERIORITY|||||||0.001|||||||t-test, 2 sided|||||||0.001
72522371|NCT00356057|144574236|SUPERIORITY|||||||0.039|||||||t-test, 2 sided|||||||0.039
72522372|NCT00356057|144574236|SUPERIORITY|||||||0.047|||||||t-test, 2 sided|||||||0.047
72522373|NCT01000818|144574237|NON_INFERIORITY_OR_EQUIVALENCE|The raltegravir AUC0-12 hr geometric mean ratio (raltegravir + omeprazole/raltegravir) is noniferior at less than 2.0.|Geometric Mean Ratio|1.39||||||95.0|1.04|1.84||||||||1.84|1.04|
72522374|NCT01000818|144574237|NON_INFERIORITY_OR_EQUIVALENCE|The raltegravir AUC0-12 hr geometric mean ratio (raltegravir + omeprazole/raltegravir) is noniferior at less than 2.0.|Geometric Mean Ratio|1.45||||||95.0|1.09|1.93||||||||1.93|1.09|
72522375|NCT02120352|144574244|OTHER||Difference in Percentage|3.7|||||TWO_SIDED|95.0|-4.8|12.2|||||Comparison between CAB LA 600 mg+RPV LA 900 mg IM-Q8W and CAB 30 mg+ABC/3TC QD|||12.2|-4.8|
72522376|NCT02120352|144574244|OTHER||Difference in Percentage|2.8|||||TWO_SIDED|95.0|-5.8|11.5|||||Comparison between CAB LA 400 mg+RPV LA 600 mg IM-Q4W and CAB 30 mg+ABC/3TC QD|||11.5|-5.8|
72522377|NCT02427100|144574309|SUPERIORITY_OR_OTHER|||||||0.18|||||||ANCOVA|||||||.18
72522378|NCT02427100|144574310|SUPERIORITY_OR_OTHER|||||||0.00036||||||The Linear Mixed Model (LMM) regression analysis (repeated measures) was adjusted for daily minutes of accelerometer wear time, gender, age, BMI, education, and meeting physical activity guidelines at baseline.|Mixed Models Analysis|A fourth root transformation of daily accelerometer-measured minutes of MVPA was used to normalize the distribution and was included in the analyses.||||||.00036
72522379|NCT00444964|144574311|OTHER||||||<|0.05|||||||Mixed Models Analysis|||||||<0.05
72522380|NCT00444964|144574312|OTHER||||||<|0.05|||||||Mixed Models Analysis|||||||<0.05
72570253|NCT02504671|144670135|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||Week 6, ACR70. Difference to Placebo is presented for Week 6. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
72522381|NCT00444964|144574313|OTHER||||||<|0.05|||||||Mixed Models Analysis|||||||<0.05
72522382|NCT02573233|144574326|SUPERIORITY|||||||0.84||||||Threshold for significance at 0.05 level|Rank ANCOVA|Rank ANCOVA model stratified by ICS dose level and region||Analysis was performed using a rank ANCOVA model stratified by ICS dose level and region.||||0.8400
72522383|NCT02573233|144574327|SUPERIORITY||LS Mean Difference|-235.02||||0.0336|TWO_SIDED|90.0|-414.19|-55.84||Threshold for significance at 0.05 level|Linear fixed-effect model|||Analysis was performed using a linear fixed-effect model with treatment, region and ICS dose level as fixed effects, and the baseline value as continuous covariate.||-55.84|-414.19|0.0336
72522384|NCT02573233|144574328|SUPERIORITY||LS mean difference|13.89||||0.4795|TWO_SIDED|90.0|-19.0|46.78||Threshold for significance at 0.05 level.|Linear fixed-effect model|||Analysis was performed using a linear fixed-effect model with treatment, region and ICS dose level as fixed effects, and the baseline value as continuous covariate.||46.78|-19.00|0.4795
72522385|NCT02573233|144574329|SUPERIORITY||LS mean difference|-18.98||||0.4494|TWO_SIDED|90.0|-60.92|22.97||Threshold for significance at 0.05 level.|Linear fixed-effect model|||Analysis was performed using a linear fixed-effect model with treatment, region and ICS dose level as fixed effects, and the baseline value as continuous covariate.||22.97|-60.92|0.4494
72522386|NCT02573233|144574330|SUPERIORITY|||||||0.6865||||||Threshold for significance at 0.05 level.|Rank ANCOVA|Rank ANCOVA model stratified by ICS dose level and region||Analysis was performed using a rank ANCOVA model stratified by ICS dose level and region.||||0.6865
72570254|NCT02504671|144670135|OTHER||Difference|32.4|||||TWO_SIDED|95.0|12.4|52.4|||||Week 8, ACR20. Difference to Placebo is presented for Week 8. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||52.4|12.4|
72570255|NCT02504671|144670135|OTHER||Difference|35.1|||||TWO_SIDED|95.0|15.1|55.1|||||Week 8, ACR20. Difference to Placebo is presented for Week 8. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||55.1|15.1|
72625059|NCT02908178|144779742|OTHER||Odds Ratio (OR)|4.45|||<|0.001|TWO_SIDED|99.0|2.27|8.75||P-value is unadjusted. Threshold for statistical significance is 0.01.|Chi-squared||Reference is no SLNB. Odds ratio accounts for matching and adjusted for subsequent mastectomy within 180 days after initial BCS, prior MRI, and radiation therapy status|Testing the association between use of sentinel lymph node biopsy (SLNB) and lymphedema in the Aim 1 matched cohort.||8.75|2.27|<.001
72522387|NCT02573233|144574331|SUPERIORITY|||||||0.7588||||||Threshold for significance at 0.05 level|Rank ANCOVA|Rank ANCOVA model stratified by ICS dose level and region||Analysis was performed using a rank ANCOVA model stratified by ICS dose level and region.||||0.7588
72522388|NCT02573233|144574332|SUPERIORITY||LS Mean Difference|-22.4||||0.0012|TWO_SIDED|90.0|-32.9|-11.9||Threshold for significance at 0.05 level|MMRM|||Analysis was performed using a Mixed-effect Model with Repeated Measures (MRMM) with treatment, treatment-by-visit interaction, region, and ICS dose level as fixed effects, and baseline biomarker-by-visit interaction as fixed covariate, and assuming an unstructured covariance structure separately by treatment group.||-11.9|-32.9|0.0012
72522389|NCT02573233|144574333|SUPERIORITY||LS Mean Difference|-22.0||||0.0005|TWO_SIDED|90.0|-31.3|-12.8||Threshold for significance at 0.05 level|MMRM|||Analysis was performed using a Mixed-effect model with Repeated Measures (MMRM) with treatment, treatment-by-visit interaction, region, and ICS dose level as fixed effects, and baseline biomarker-by-visit interaction as fixed covariate, and assuming an unstructured covariance structure separately by treatment group.||-12.8|-31.3|0.0005
72522390|NCT05103475|144574347|OTHER|Please note that all data analyses were exploratory because this was feasibility pilot.||||||1||||||The investigators used Fisher's exact due to small cell sizes.|Fisher Exact|The reported value represents the calculated p-value for the Fisher's Exact test.||||||1.0
72522391|NCT05103475|144574348|OTHER|Please note that all data analyses were exploratory because this was feasibility pilot.||||||0.35|||||||t-test, 2 sided|||||||0.35
72522392|NCT05103475|144574349|OTHER|Please note that all data analyses were exploratory because this was feasibility pilot.||||||0.15||||||The investigators used Fisher's Exact due to small cell sizes.|Fisher Exact|||||||0.15
72522393|NCT05103475|144574350|OTHER|Please note that all data analyses were exploratory because this was feasibility pilot.||||||0.43|||||||t-test, 2 sided|||Pre/post comparison for control group scores.||||0.43
72522394|NCT05103475|144574350|OTHER|Please note that all data analyses were exploratory because this was feasibility pilot.||||||0.24|||||||t-test, 2 sided|||Pre/post comparison for RAP group score.||||0.24
72522395|NCT05103475|144574350|OTHER|Please note that all data analyses were exploratory because this was feasibility pilot.||||||0.53||||||F = 0.41|ANOVA|||ANOVA results - group x time interaction.||||0.53
72522396|NCT05103475|144574351|OTHER|Please note that all data analyses were exploratory because this was feasibility pilot.||||||0.7|||||||t-test, 2 sided|||Pre/post comparison for control group.||||0.70
72522397|NCT05103475|144574351|OTHER|Please note that all data analyses were exploratory because this was feasibility pilot.||||||0.17|||||||t-test, 2 sided|||Pre/post comparison for RAP group.||||0.17
72522398|NCT05103475|144574351|OTHER|Please note that all data analyses were exploratory because this was feasibility pilot.||||||0.18||||||F = 1.95|ANOVA|||ANOVA results - group x time interaction.||||0.18
72522399|NCT05103475|144574352|OTHER|Please note that all data analyses were exploratory because this was feasibility pilot.||||||0.37|||||||t-test, 2 sided|||Pre/post comparison - control group.||||0.37
72570256|NCT02504671|144670135|OTHER||Difference|21.6|||||TWO_SIDED|95.0|6.8|36.4|||||Week 8, ACR50. Difference to Placebo is presented for Week 8. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||36.4|6.8|
72570257|NCT02504671|144670135|OTHER||Difference|16.2|||||TWO_SIDED|95.0|2.6|29.9|||||Week 8, ACR50. Difference to Placebo is presented for Week 8. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||29.9|2.6|
72570258|NCT02504671|144670135|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-4.8|15.6|||||Week 8, ACR70. Difference to Placebo is presented for Week 8. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||15.6|-4.8|
72570259|NCT02504671|144670135|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-4.8|15.6|||||Week 8, ACR70. Difference to Placebo is presented for Week 8. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||15.6|-4.8|
72570260|NCT02504671|144670135|OTHER||Difference|29.7|||||TWO_SIDED|95.0|11.0|48.4|||||Week 12, ACR20. Difference to Placebo is presented for Week 8. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||48.4|11.0|
72570261|NCT02504671|144670135|OTHER||Difference|40.5|||||TWO_SIDED|95.0|21.6|59.5|||||Week 12, ACR20. Difference to Placebo is presented for Week 8. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||59.5|21.6|
72570262|NCT02504671|144670135|OTHER||Difference|21.6|||||TWO_SIDED|95.0|4.5|38.8|||||Week 12, ACR50. Difference to Placebo is presented for Week 12. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||38.8|4.5|
72625060|NCT02908178|144779742|OTHER||Odds Ratio (OR)|1.24|||<|0.001|TWO_SIDED|99.0|1.0|1.54||P-value is unadjusted. Threshold for statistical significance is 0.01.|Chi-squared||Reference is no SLNB. Odds ratio accounts for matching and adjusted for subsequent mastectomy within 180 days after initial BCS, prior MRI, and radiation therapy status|Testing the association between use of sentinel lymph node biopsy (SLNB) and wound infection in the Aim 1 matched cohort.||1.54|1.00|<.001
72522400|NCT05103475|144574352|OTHER|Please note that all data analyses were exploratory because this was feasibility pilot.||||||0.5|||||||t-test, 2 sided|||Pre/post comparison - RAP group.||||0.50
72522401|NCT05103475|144574352|OTHER|Please note that all data analyses were exploratory because this was feasibility pilot.||||||0.9||||||F = 0.01|ANOVA|||ANOVA results - group x time interaction.||||0.90
72522402|NCT05103475|144574353|OTHER|Please note that all data analyses were exploratory because this was feasibility pilot.||||||0.56|||||||t-test, 2 sided|||Pre/post comparison - control group.||||0.56
72522403|NCT05103475|144574353|OTHER|Please note that all data analyses were exploratory because this was feasibility pilot.||||||0.32|||||||t-test, 2 sided|||Pre/post comparison - RAP group.||||0.32
72522404|NCT05103475|144574353|OTHER|Please note that all data analyses were exploratory because this was feasibility pilot.||||||0.41||||||F = 0.71|ANOVA|||ANOVA results - group x time interaction.||||0.41
72570263|NCT02504671|144670135|OTHER||Difference|13.5|||||TWO_SIDED|95.0|-2.4|29.4|||||Week 12, ACR50. Difference to Placebo is presented for Week 12. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||29.4|-2.4|
72570264|NCT02504671|144670135|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-8.7|14.1|||||Week 12, ACR70. Difference to Placebo is presented for Week 12. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||14.1|-8.7|
72522405|NCT05103475|144574354|OTHER|Please note that all data analyses were exploratory because this was feasibility pilot.||||||0.5|||||||t-test, 2 sided|||Pre/post comparison - control group.||||0.50
72522406|NCT05103475|144574354|OTHER|Please note that all data analyses were exploratory because this was feasibility pilot.||||||0.6|||||||t-test, 2 sided|||Pre/post comparison - RAP group.||||0.60
72522407|NCT05103475|144574354|OTHER|Please note that all data analyses were exploratory because this was feasibility pilot.||||||0.98||||||F = 0.0|ANOVA|||ANOVA results - group x time interaction.||||0.98
72522408|NCT05103475|144574355|OTHER|Please note that all data analyses were exploratory because this was feasibility pilot.||||||0.54|||||||t-test, 2 sided|||Pre/post comparison - control group.||||0.54
72522409|NCT05103475|144574355|OTHER|Please note that all data analyses were exploratory because this was feasibility pilot.||||||0.15|||||||t-test, 2 sided|||Pre/post comparison - RAP group.||||0.15
72522410|NCT05103475|144574355|OTHER|Please note that all data analyses were exploratory because this was feasibility pilot.||||||0.04||||||F = 4.9|ANOVA|||ANOVA results - group x time interaction.||||0.04
72522411|NCT05103475|144574356|OTHER|Please note that all data analyses were exploratory because this was feasibility pilot.||||||0.11|||||||t-test, 2 sided|||Pre/post comparison - control group.||||0.11
72522412|NCT05103475|144574356|OTHER|Please note that all data analyses were exploratory because this was feasibility pilot.||||||0.09|||||||t-test, 2 sided|||Pre/post comparison - RAP group.||||0.09
72522413|NCT05103475|144574356|OTHER|Please note that all data analyses were exploratory because this was feasibility pilot.||||||0.75||||||F = 0.10|ANOVA|||ANOVA results - group x time interaction.||||0.75
72570265|NCT02504671|144670135|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-7.0|17.8|||||Week 12, ACR70. Difference to Placebo is presented for Week 12. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||17.8|-7.0|
72570266|NCT02504671|144670135|OTHER||Difference|24.3|||||TWO_SIDED|95.0|4.5|44.1|||||Week 16, ACR20. Difference to Placebo is presented for Week 16. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||44.1|4.5|
72570267|NCT02504671|144670135|OTHER||Difference|51.4|||||TWO_SIDED|95.0|32.2|70.5|||||Week 16, ACR20. Difference to Placebo is presented for Week 16. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||70.5|32.2|
72570268|NCT02504671|144670135|OTHER||Difference|18.9|||||TWO_SIDED|95.0|2.1|35.7|||||Week 16, ACR50. Difference to Placebo is presented for Week 16. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||35.7|2.1|
72570269|NCT02504671|144670135|OTHER||Difference|13.5|||||TWO_SIDED|95.0|-2.4|29.4|||||Week 16, ACR50. Difference to Placebo is presented for Week 16. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||29.4|-2.4|
72570270|NCT02504671|144670135|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-7.0|17.8|||||Week 16, ACR70. Difference to Placebo is presented for Week 16. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||17.8|-7.0|
72570271|NCT02504671|144670135|OTHER||Difference|21.6|||||TWO_SIDED|95.0|2.0|41.2|||||Week 20, ACR20. Difference to Placebo is presented for Week 20. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||41.2|2.0|
72570272|NCT02504671|144670135|OTHER||Difference|43.2|||||TWO_SIDED|95.0|23.5|63.0|||||Week 20, ACR20. Difference to Placebo is presented for Week 20. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||63.0|23.5|
72522414|NCT05103475|144574357|OTHER|Please note that all data analyses were exploratory because this was feasibility pilot.||||||0.41|||||||Fisher Exact|The investigators used Fisher's Exact due to small cell sizes.||Likelihood to participate in a program like it in the future||||0.41
72522415|NCT05103475|144574357|OTHER|Please note that all data analyses were exploratory because this was feasibility pilot.||||||0.003||||||The investigators used Fisher's Exact due to small cell sizes.|Fisher Exact|||Help to manage back pain.||||0.003
72522416|NCT05103475|144574357|OTHER|Please note that all data analyses were exploratory because this was feasibility pilot.||||||1||||||The investigators used Fisher's Exact due to small sample sizes.|Fisher Exact|The reported value represents the calculated p-value for the Fisher's Exact test.||Would recommend to another Veteran.||||1.00
72522417|NCT05103475|144574357|OTHER|Please note that all data analyses were exploratory because this was feasibility pilot.||||||0.07||||||The investigators used Fisher's Exact due to small cell sizes.|Fisher Exact|||Liked the program.||||0.07
72522418|NCT05103475|144574358|OTHER|Please note that all data analyses were exploratory because this was feasibility pilot.||||||0.91|||||||t-test, 2 sided|||Pre/post comparison - control group.||||0.91
72522419|NCT05103475|144574358|OTHER|Please note that all data analyses were exploratory because this was feasibility pilot.||||||0.51|||||||t-test, 2 sided|||Pre/post comparison - RAP group.||||0.51
72522420|NCT05103475|144574358|OTHER|Please note that all data analyses were exploratory because this was feasibility pilot.||||||0.42||||||F = 0.68|ANOVA|||ANOVA results - group x time interaction.||||0.42
72522421|NCT00924729|144574359|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.0001
72522422|NCT02023112|144574366|SUPERIORITY_OR_OTHER_LEGACY||percentage of participants with SVR12|91.5|||||TWO_SIDED|95.0|80.1|96.6|||||Tested using the following hierarchical order: among non-cirrhotic treatment-naïve participants 1) superiority of 16-week treatment arm to a clinically relevant threshold; 2) superiority of 12-week treatment arm to a clinically relevant threshold.|"Among non-cirrhotic treatment-naïve participants, superiority of the 16-week treatment arm to a clinically relevant threshold.~Lower bound of 95% confidence interval (LCB) must have exceeded 67% to achieve superiority. Threshold indicates value the LCB had to exceed to demonstrate superiority for the treatment arm and was based on the SVR rates with pegylated-interferon (IFN) alfa-2a or 2b/RBV in treatment-naïve, noncirrhotic HCV genotype 2-infected participants."||96.6|80.1|
72570273|NCT02504671|144670135|OTHER||Difference|24.3|||||TWO_SIDED|95.0|6.9|41.8|||||Week 20, ACR50. Difference to Placebo is presented for Week 20. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||41.8|6.9|
72522423|NCT02023112|144574366|SUPERIORITY_OR_OTHER_LEGACY||percentage of participants with SVR12|75.0|||||TWO_SIDED|95.0|61.2|85.1|||||Tested using the following hierarchical order: among non-cirrhotic treatment-naïve participants 1) superiority of 16-week treatment arm to a clinically relevant threshold; 2) superiority of 12-week treatment arm to a clinically relevant threshold.|"Among non-cirrhotic treatment-naïve participants, superiority of the 12-week treatment arm to a clinically relevant threshold.~LCB must have exceeded 67% to achieve superiority. Threshold indicates value the LCB had to exceed to demonstrate superiority for the treatment arm and was based on the SVR rates with pegylated-IFN alfa-2a or 2b/RBV in treatment-naïve, noncirrhotic HCV genotype 2-infected participants."||85.1|61.2|
72522424|NCT03536923|144574378|OTHER|||||||0.0001|||||||t-test, 1 sided|||||||0.0001
72522425|NCT03536923|144574379|OTHER|||||||0.0009|||||||t-test, 1 sided|||||||0.0009
72522426|NCT03536923|144574381|OTHER|||||||0.0001|||||||t-test, 1 sided|||||||0.0001
72522427|NCT02228824|144574385|SUPERIORITY||Mean Difference (Final Values)|1.51|||<|0.001|TWO_SIDED|95.0|0.86|2.17|||ANCOVA|ANCOVA was performed on 25 sets of imputed data and then analyzed using SAS PROC MIANALYZE||||2.17|0.86|<0.001
72522428|NCT02228824|144574387|SUPERIORITY||Mean Difference (Final Values)|-38.5||||0.041|TWO_SIDED|95.0|-75.21|-1.78|||Mixed Models Analysis|||||-1.78|-75.21|0.041
72522429|NCT02228824|144574388|SUPERIORITY||Mean Difference (Final Values)|-0.7||||0.016|TWO_SIDED|95.0|-1.26|-0.13|||ANCOVA|ANCOVA was performed on 25 sets of imputed data and then analyzed using SAS PROC MIANALYZE||||-0.13|-1.26|0.016
72522430|NCT02228824|144574389|SUPERIORITY||Mean Difference (Final Values)|-0.02||||0.03|TWO_SIDED|95.0|-0.04|-0.002|||Mixed Models Analysis|||||-0.002|-0.04|0.03
72522431|NCT04018612|144574413|SUPERIORITY||LS Mean Difference|-21.84|STANDARD_ERROR_OF_MEAN|11.091||0.0258|ONE_SIDED|90.0||-7.53|||ANCOVA||SPID24 was analyzed using ANCOVA model with treatment group as a fixed effect and baseline (BL) Pain Intensity-Numerical Pain Relief Scale (PI-NPRS) as a covariate. The lower limit of one-sided 90% confidence interval (CI) was -∞|||-7.53||0.0258
72522432|NCT04018612|144574413|SUPERIORITY||LS Mean Difference|-25.74|STANDARD_ERROR_OF_MEAN|11.154||0.0115|ONE_SIDED|90.0||-11.35|||ANCOVA||SPID24 was analyzed using an analysis of covariance (ANCOVA) model with treatment group as a fixed effect and baseline PI-NPRS as a covariate. The lower limit of one-sided 90% CI was -∞|||-11.35||0.0115
72522433|NCT04018612|144574414|SUPERIORITY||LS Mean Difference|12.72|STANDARD_ERROR_OF_MEAN|5.267||0.0087|ONE_SIDED|90.0|5.92||||ANCOVA||TOTPAR24 was analyzed using an ANCOVA model with treatment group as a fixed effect and baseline PI-NPRS as a covariate. The upper limit of one-sided 90% CI was +∞||||5.92|0.0087
72522434|NCT04018612|144574414|SUPERIORITY||LS Mean Difference|12.14|STANDARD_ERROR_OF_MEAN|5.297||0.012|ONE_SIDED|90.0|5.31||||ANCOVA||TOTPAR24 was analyzed using an ANCOVA model with treatment group as a fixed effect and baseline PI-NPRS as a covariate. The upper limit of one-sided 90% CI was +∞||||5.31|0.0120
72522435|NCT02999191|144574452|OTHER||Ratio|89.9|STANDARD_DEVIATION|36.0|||TWO_SIDED|90.0|73.304|110.25|||ANOVA||The estimated parameter was the adjusted geometric mean ratios \[%\] of BI 1467335: Tablets, fasted (numerator) and Solution, fasted (denominator). The Standard Deviation \[SD\] is the intra-individual geometric coefficient of variation \[%\].|The statistical model used for the analysis of the endpoint was an ANOVA \[Analysis of Variance\] model on the logarithmic scale. This model included effects accounting for the following sources of variation: 'sequence', 'subjects nested within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||110.25|73.304|
72570274|NCT02504671|144670135|OTHER||Difference|21.6|||||TWO_SIDED|95.0|4.5|38.8|||||Week 20, ACR50. Difference to Placebo is presented for Week 20. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||38.8|4.5|
72570275|NCT02504671|144670135|OTHER||Difference|18.9|||||TWO_SIDED|95.0|3.3|34.5|||||Week 20, ACR70. Difference to Placebo is presented for Week 20. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||34.5|3.3|
72406088|NCT00653224|144320434|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.17||||0.535||95.0|-0.7|0.37||If the p-value of this estimated difference is lower than 5% the mean change from baseline in ESS score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on change from baseline in ESS score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean change from baseline in ESS score at week 1 is not different from subjects treated with levocetirizine than subjects treated with placebo.'||0.37|-0.70|0.535
72522436|NCT02999191|144574452|OTHER||Ratio|170.78|STANDARD_DEVIATION|33.9|||TWO_SIDED|90.0|139.85|208.54|||ANOVA||The estimated parameter was the adjusted geometric mean ratios \[%\] of BI 1467335: Tablets, fed (numerator) and Tablets, fasted (denominator). The parameter dispersion type \[SD\] is the intra-individual geometric coefficient of variation \[%\].|The statistical model used for the analysis of the endpoint was an ANOVA \[Analysis of Variance\] model on the logarithmic scale. This model included effects accounting for the following sources of variation: 'sequence', 'subjects nested within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||208.54|139.85|
72522437|NCT02999191|144574453|OTHER||Ratio|84.17|STANDARD_DEVIATION|48.8|||TWO_SIDED|90.0|64.26|110.24|||ANOVA||The estimated parameter was the adjusted geometric mean ratios \[%\] of BI 1467335: Tablets, fasted (numerator) and Solution, fasted (denominator). The parameter dispersion type \[SD\] is the intra-individual geometric coefficient of variation \[%\].|The statistical model used for the analysis of the endpoint was an ANOVA \[Analysis of Variance\] model on the logarithmic scale. This model included effects accounting for the following sources of variation: 'sequence', 'subjects nested within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||110.24|64.260|
72522438|NCT02999191|144574453|OTHER||Ratio|136.16|STANDARD_DEVIATION|54.8|||TWO_SIDED|90.0|99.885|185.61|||ANOVA||The estimated parameter was the adjusted geometric mean ratios \[%\] of BI 1467335: Tablets, fed (numerator) and Tablets, fasted (denominator). The parameter dispersion type \[SD\] is the intra-individual geometric coefficient of variation \[%\].|The statistical model used for the analysis of the endpoint was an ANOVA \[Analysis of Variance\] model on the logarithmic scale. This model included effects accounting for the following sources of variation: 'sequence', 'subjects nested within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||185.61|99.885|
72522439|NCT00807014|144574463|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Analysis of covariance (ANCOVA) model was used with terms for baseline value, treatment, and center. Treatment-by-center interaction was not included.|ANCOVA|||||||<0.001
72522440|NCT01628042|144574482|SUPERIORITY_OR_OTHER||Geometric least-squares mean ratio|1.83|||||TWO_SIDED|90.0|1.36|2.46|||ANCOVA|||||2.46|1.36|
72522441|NCT01628042|144574482|SUPERIORITY_OR_OTHER||Geometric least-squares mean ratio|2.06|||||TWO_SIDED|90.0|1.55|2.74|||ANCOVA|||||2.74|1.55|
72522442|NCT01628042|144574482|SUPERIORITY_OR_OTHER||Geometric least-squares mean ratio|1.49|||||TWO_SIDED|90.0|1.11|2.0|||ANCOVA|||||2.00|1.11|
72522443|NCT01628042|144574483|SUPERIORITY_OR_OTHER||Geometric least-squares mean ratio|1.42|||||TWO_SIDED|90.0|0.89|2.27|||ANCOVA|||||2.27|0.89|
72522444|NCT01628042|144574483|SUPERIORITY_OR_OTHER||Geometric least-squares mean ration|1.68|||||TWO_SIDED|90.0|1.07|2.63|||ANCOVA|||||2.63|1.07|
72522445|NCT01628042|144574483|SUPERIORITY_OR_OTHER||Geometric least-squares mean ratio|1.96|||||TWO_SIDED|90.0|1.23|3.13|||ANCOVA|||||3.13|1.23|
72522446|NCT01628042|144574484|SUPERIORITY_OR_OTHER||Geometric least squares mean ratio|0.55|||||TWO_SIDED|90.0|0.41|0.74|||ANCOVA|||||0.74|0.41|
72522447|NCT01628042|144574484|SUPERIORITY_OR_OTHER||Geometric least squares mean ratio|0.49|||||TWO_SIDED|90.0|0.36|0.65|||ANCOVA|||||0.65|0.36|
72522448|NCT01628042|144574484|SUPERIORITY_OR_OTHER||Geometric least squares mean ratio|0.67|||||TWO_SIDED|90.0|0.5|0.9|||ANCOVA|||||0.90|0.50|
72570276|NCT02504671|144670135|OTHER||Difference|13.5|||||TWO_SIDED|95.0|-1.1|28.1|||||Week 20, ACR70. Difference to Placebo is presented for Week 20. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||28.1|-1.1|
72522449|NCT01696396|144574491|SUPERIORITY|The study was powered for formal statistical testing of the abrilumab 70 mg group. The primary and key secondary endpoints were tested under a sequential framework of statistical hypotheses, each with 2-sided significance level of 0.10 for the treatment effect of abrilumab 70 mg compared with placebo.|Odds Ratio (OR)|1.15||||0.76|TWO_SIDED|90.0|0.54|2.44|||Regression, Logistic|Adjusted for baseline CDAI score and stratification factors.|An odds ratio \> 1.0 indicates a higher remission rate for the abrilumab treatment group relative to placebo.|Comparisons between treatment groups were made using remission rates estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||2.44|0.54|0.76
72522450|NCT01696396|144574491|SUPERIORITY||Difference in Adjusted Remission Rates|1.6|||||TWO_SIDED|90.0|-7.9|8.9||||||The difference in remission rates, estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||8.9|-7.9|
72522451|NCT01696396|144574491|SUPERIORITY|Analysis was not part of the formal testing|Odds Ratio (OR)|1.91||||0.22|TWO_SIDED|90.0|0.8|4.57|||Regression, Logistic|Adjusted for baseline CDAI score and stratification factors.|An odds ratio \> 1.0 indicates a higher remission rate for the abrilumab treatment group relative to placebo.|Comparisons between treatment groups were made using remission rates estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||4.57|0.80|0.22
72522452|NCT01696396|144574491|SUPERIORITY|Analysis was not part of the formal testing|Difference in Adjusted Remission Rates|9.1|||||TWO_SIDED|90.0|-4.6|19.4||||||The difference in remission rates, estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||19.4|-4.6|
72570277|NCT02504671|144670135|OTHER||Difference|27.0|||||TWO_SIDED|95.0|7.7|46.3|||||Week 24, ACR20. Difference to Placebo is presented for Week 24. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||46.3|7.7|
72570278|NCT02504671|144670135|OTHER||Difference|45.9|||||TWO_SIDED|95.0|26.7|65.2|||||Week 24, ACR20. Difference to Placebo is presented for Week 24. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||65.2|26.7|
72522453|NCT01696396|144574491|SUPERIORITY|Analysis was not part of the formal testing|Odds Ratio (OR)|2.05||||0.25|TWO_SIDED|90.0|0.74|5.73|||Regression, Logistic|Adjusted for baseline total CDAI score and stratification factors.|An odds ratio \> 1.0 indicates a higher remission rate for the abrilumab treatment group relative to placebo.|Comparisons between treatment groups were made using remission rates estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||5.73|0.74|0.25
72522454|NCT01696396|144574491|SUPERIORITY|Analysis was not part of the formal testing|Difference in Adjusted Remission Rates|10.3|||||TWO_SIDED|90.0|-6.8|22.6||||||The difference in remission rates, estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||22.6|-6.8|
72406089|NCT00653224|144320435|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.64||||0.042||95.0|-1.26|-0.02||If the p-value of this estimated difference is lower than 5% the mean change from baseline in ESS score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on change from baseline in ESS score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean change from baseline in ESS score at week 2 is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.02|-1.26|0.042
72406090|NCT00653224|144320436|SUPERIORITY_OR_OTHER|||||||0.171||95.0||||If the p-value of this estimated difference is lower than 5% the change from baseline is considered as different between the two treatment groups.|Repeated measure analysis (CATMOD)|||The Null Hypothesis is expressed as follows: 'The change from baseline to endpoint visit in score category (ESS score \< 8 or \>= 8) is not different from subjects treated with levocetirizine than subjects treated with placebo.'||||0.171
72522455|NCT01696396|144574492|SUPERIORITY||Odds Ratio (OR)|1.78||||0.16|TWO_SIDED|90.0|0.9|3.53|||Regression, Logistic|Adjusted for baseline CDAI score and stratification factors.|An odds ratio \> 1.0 indicates a higher remission rate for the abrilumab treatment group relative to placebo.|Comparisons between treatment groups were made using remission rates estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||3.53|0.90|0.16
72522456|NCT01696396|144574492|SUPERIORITY||Difference in Adjusted Remission Rates|10.9|||||TWO_SIDED|90.0|-1.8|21.0||||||The difference in remission rates, estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||21.0|-1.8|
72522457|NCT01696396|144574492|SUPERIORITY|Analysis was not part of the formal testing|Odds Ratio (OR)|2.12||||0.13|TWO_SIDED|90.0|0.93|4.84|||Regression, Logistic|Adjusted for baseline CDAI score and stratification factors.|An odds ratio \> 1.0 indicates a higher remission rate for the abrilumab treatment group relative to placebo.|Comparisons between treatment groups were made using remission rates estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||4.84|0.93|0.13
72522458|NCT01696396|144574492|SUPERIORITY|Analysis was not part of the formal testing|Difference in Adjusted Remission Rates|14.7|||||TWO_SIDED|90.0|-2.1|27.5||||||The difference in remission rates, estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||27.5|-2.1|
72522459|NCT01696396|144574492|SUPERIORITY|Analysis was not part of the formal testing|Odds Ratio (OR)|3.1||||0.056|TWO_SIDED|90.0|1.17|8.2|||Regression, Logistic|Adjusted for baseline total CDAI score and stratification factors.|An odds ratio \> 1.0 indicates a higher remission rate for the abrilumab treatment group relative to placebo.|Comparisons between treatment groups were made using remission rates estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||8.20|1.17|0.056
72522460|NCT01696396|144574492|SUPERIORITY|Analysis was not part of the formal testing|Difference in Adjusted Remission Rates|23.7|||||TWO_SIDED|90.0|2.8|39.2||||||The difference in remission rates, estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||39.2|2.8|
72522461|NCT01696396|144574493|SUPERIORITY||Odds Ratio (OR)|2.25||||0.021|TWO_SIDED|90.0|1.27|4.01|||Regression, Logistic|Adjusted for baseline CDAI score and stratification factors.|An odds ratio \> 1.0 indicates a higher response rate for the abrilumab treatment group relative to placebo.|Comparisons between treatment groups were made using response rates estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||4.01|1.27|0.021
72522462|NCT01696396|144574493|SUPERIORITY||Difference in Adjusted Response Rates|19.8|||||TWO_SIDED|90.0|5.8|31.3||||||The difference in response rates, estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||31.3|5.8|
72570279|NCT02504671|144670135|OTHER||Difference|13.5|||||TWO_SIDED|95.0|-3.6|30.6|||||Week 24, ACR50. Difference to Placebo is presented for Week 24. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||30.6|-3.6|
72570280|NCT02504671|144670135|OTHER||Difference|16.2|||||TWO_SIDED|95.0|-1.2|33.7|||||Week 24, ACR50. Difference to Placebo is presented for Week 24. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||33.7|-1.2|
72406091|NCT04482179|144320453|SUPERIORITY||||||<|0.05|||||||Regression, Linear|||||||<.05
72406092|NCT04482179|144320454|SUPERIORITY||||||<|0.05|||||||Regression, Linear|||||||<.05
72406093|NCT04988295|144320455|SUPERIORITY||Hazard Ratio (HR)|0.44|||<|0.0001|TWO_SIDED|95.0|0.35|0.56|||Log Rank|||||0.56|0.35|<0.0001
72570281|NCT02504671|144670135|OTHER||Difference|13.5|||||TWO_SIDED|95.0|-1.1|28.1|||||Week 24, ACR70. Difference to Placebo is presented for Week 24. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||28.1|-1.1|
72570282|NCT02504671|144670135|OTHER||Difference|13.5|||||TWO_SIDED|95.0|-1.1|28.1|||||Week 24, ACR70. Difference to Placebo is presented for Week 24. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||28.1|-1.1|
72570283|NCT02504671|144670135|OTHER||Difference|13.5|||||TWO_SIDED|95.0|0.5|26.5|||||Week 28, ACR20. Difference to Placebo is presented for Week 28. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||26.5|0.5|
72406094|NCT04988295|144320455|SUPERIORITY||Hazard Ratio (HR)|0.48|||<|0.0001||95.0|0.36|0.64|||Log Rank|||||0.64|0.36|<0.0001
72406095|NCT05358821|144320490|SUPERIORITY||Mean Difference|3.3657|STANDARD_ERROR_OF_MEAN|0.2539|<|0.0001|TWO_SIDED|95.0|2.8566|3.8749|||T-test||Difference was calculated as HP - HD.|||3.8749|2.8566|<0.0001
72406096|NCT02504372|144320494|OTHER||Hazard Ratio (HR)|0.81|||||TWO_SIDED|95.0|0.68|0.96|||||HR and 95% confidence interval (95%CI) were based on multivariate Cox regression model with treatment adjusted by stage, PD-L1 status, adjuvant chemotherapy, region, histology, and smoking status.|||0.96|0.68|
72406097|NCT02504372|144320495|OTHER||Hazard Ratio (HR)|0.83||||0.13499|TWO_SIDED|95.0|0.59|1.16|||Regression, Cox|One-sided p-value was based on the permutation test with multivariate Cox regression model.|HR and 95% confidence interval (95%CI) were based on multivariate Cox regression model with treatment adjusted by stage, PD-L1 status, adjuvant chemotherapy, region, histology, and smoking status.|||1.16|0.59|0.13499
72522463|NCT01696396|144574493|SUPERIORITY|Analysis was not part of the formal testing|Odds Ratio (OR)|1.9||||0.14|TWO_SIDED|90.0|0.94|3.87|||Regression, Logistic|Adjusted for baseline CDAI score and stratification factors.|An odds ratio \> 1.0 indicates a higher response rate for the abrilumab treatment group relative to placebo.|Comparisons between treatment groups were made using response rates estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||3.87|0.94|0.14
72522464|NCT01696396|144574493|SUPERIORITY|Analysis was not part of the formal testing|Difference in Adjusted Response Rates|15.7|||||TWO_SIDED|90.0|-2.3|29.7||||||The difference in response rates, estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||29.7|-2.3|
72570284|NCT02504671|144670135|OTHER||Difference|64.9|||||TWO_SIDED|95.0|48.9|80.8|||||Week 28, ACR20. Difference to Placebo is presented for Week 28. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||80.8|48.9|
72570285|NCT02504671|144670135|OTHER||Difference|13.5|||||TWO_SIDED|95.0|0.5|26.5|||||Week 28, ACR50. Difference to Placebo is presented for Week 28. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||26.5|0.5|
72406098|NCT02504372|144320496|OTHER||Hazard Ratio (HR)|0.78||||0.01327|TWO_SIDED|95.0|0.62|0.97|||Regression, Cox|One-sided p-value was based on the permutation test with multivariate Cox regression model.|HR and 95% confidence interval (95%CI) were based on multivariate Cox regression model with treatment adjusted by stage, PD-L1 status, adjuvant chemotherapy, region, histology, and smoking status.|||0.97|0.62|0.01327
72406099|NCT02504372|144320503|OTHER||Hazard Ratio (HR)|0.76||||0.00143|TWO_SIDED|95.0|0.63|0.91|||Regression, Cox|One-sided p-value was based on the permutation test with multivariate Cox regression model.|HR and 95% confidence interval (95%CI) were based on multivariate Cox regression model with treatment adjusted by stage, PD-L1 status, adjuvant chemotherapy, region, histology, and smoking status.|||0.91|0.63|0.00143
72406100|NCT03901963|144320504|SUPERIORITY||Odds Ratio (OR)|4.51|||<|0.0001|TWO_SIDED|95.0|2.37|8.57||Tested at 2-sided 0.05 significance level through stratified CMH method. Stratification factor included baseline cytogenetic risk per investigator'|stratified Cochran-Mantel-Haenszel (CMH)||Odds ratio and 95% CI were estimated by Mantel-Haenszel method. Stratification factor included baseline cytogenetic risk per investigator's assessment (high risk versus standard/unknown risk) as used for randomization of the study.|||8.57|2.37|<0.0001
72570286|NCT02504671|144670135|OTHER||Difference|21.6|||||TWO_SIDED|95.0|6.8|36.4|||||Week 28, ACR50. Difference to Placebo is presented for Week 28. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||36.4|6.8|
72570287|NCT02504671|144670135|OTHER||Difference|8.1|||||TWO_SIDED|95.0|-3.2|19.4|||||Week 28, ACR70. Difference to Placebo is presented for Week 28. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||19.4|-3.2|
72406101|NCT05429203|144320523|OTHER|||||||0.8||||||The a priori threshold for statistical significance was \<0.05.|Chi-squared|||||||0.8
72406102|NCT05429203|144320524|OTHER|||||||1||||||The a priori threshold for statistical significance was \<0.05.|Fisher Exact|||||||1
72406103|NCT05429203|144320525|OTHER|||||||0.7||||||The a priori threshold for statistical significance was \<0.05.|Fisher Exact|||||||0.7
72406104|NCT05429203|144320526|OTHER|||||||0.4||||||The a priori threshold for statistical significance was \<0.05.|Fisher Exact|||||||0.4
72406105|NCT05429203|144320527|OTHER|||||||0.8||||||The a priori threshold for statistical significance was \<0.05.|Fisher Exact|||||||0.8
72570288|NCT02504671|144670135|OTHER||Difference|10.8|||||TWO_SIDED|95.0|-1.4|23.0|||||Week 28, ACR70. Difference to Placebo is presented for Week 28. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||23.0|-1.4|
72406106|NCT05429203|144320528|OTHER|||||||0.8||||||The a priori threshold for statistical significance was \<0.05.|Fisher Exact|||||||0.8
72406107|NCT05429203|144320529|OTHER|||||||0.7||||||The a priori threshold for statistical significance was \<0.05.|Fisher Exact|||||||0.7
72406108|NCT05429203|144320530|OTHER|||||||0.6||||||The a priori threshold for statistical significance was \<0.05.|Fisher Exact|||||||0.6
72406109|NCT05429203|144320531|OTHER|||||||0.5||||||The a priori threshold for statistical significance was \<0.05.|Fisher Exact|||||||0.5
72406110|NCT05429203|144320532|OTHER|||||||0.9||||||The a priori threshold for statistical significance was \<0.05.|Fisher Exact|||||||0.9
72570289|NCT02504671|144670135|OTHER||Difference|13.5|||||TWO_SIDED|95.0|0.5|26.5|||||Week 32, ACR20. Difference to Placebo is presented for Week 32. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||26.5|0.5|
72570290|NCT02504671|144670135|OTHER||Difference|51.4|||||TWO_SIDED|95.0|34.5|68.2|||||Week 32, ACR20. Difference to Placebo is presented for Week 32. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||68.2|34.5|
72570291|NCT02504671|144670135|OTHER||Difference|13.5|||||TWO_SIDED|95.0|0.5|26.5|||||Week 32, ACR50. Difference to Placebo is presented for Week 32. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||26.5|0.5|
72570292|NCT02504671|144670135|OTHER||Difference|27.0|||||TWO_SIDED|95.0|11.4|42.7|||||Week 32, ACR50. Difference to Placebo is presented for Week 32. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||42.7|11.4|
72406111|NCT05429203|144320533|OTHER|||||||0.8||||||The a priori threshold for statistical significance was \<0.05.|Fisher Exact|||||||0.8
72406112|NCT05429203|144320534|OTHER|||||||0.9||||||the a priori threshold for statistical significance was \<0.05.|Fisher Exact|||||||0.9
72406113|NCT00433654|144320536|SUPERIORITY_OR_OTHER_LEGACY||Percentage|0.0|||<|0.001|ONE_SIDED|95.0||1.7|||exact test of binomial proportions|||Null hypothesis: rate \> 10%||1.7||<0.001
72406114|NCT00433654|144320537|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority margin is 10%.|Difference in percentages|0.0||||||95.0||||P-value and confidence interval could not be calculated because both groups were 100% successful.|Farrington-Manning|||Null hypothesis: success rate MRI group \<= success rate control group - 10%||||
72570293|NCT02504671|144670135|OTHER||Difference|10.8|||||TWO_SIDED|95.0|-1.4|23.0|||||Week 32, ACR70. Difference to Placebo is presented for Week 32. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||23.0|-1.4|
72570294|NCT02504671|144670135|OTHER||Difference|13.5|||||TWO_SIDED|95.0|0.5|26.5|||||Week 32, ACR70. Difference to Placebo is presented for Week 32. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||26.5|0.5|
72570295|NCT02504671|144670135|OTHER||Difference|13.5|||||TWO_SIDED|95.0|0.5|26.5|||||Week 36, ACR20. Difference to Placebo is presented for Week 36. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||26.5|0.5|
72570296|NCT02504671|144670135|OTHER||Difference|56.8|||||TWO_SIDED|95.0|40.1|73.4|||||Week 36, ACR20. Difference to Placebo is presented for Week 36. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||73.4|40.1|
72625061|NCT02908178|144779742|OTHER||Odds Ratio (OR)|1.4|||<|0.001|TWO_SIDED|99.0|1.03|1.91||P-value is unadjusted. Threshold for statistical significance is 0.01.|Chi-squared||Reference is no SLNB. Odds ratio accounts for matching and adjusted for subsequent mastectomy within 180 days after initial BCS, prior MRI, and radiation therapy status|Testing the association between use of sentinel lymph node biopsy (SLNB) and seroma in the Aim 1 matched cohort.||1.91|1.03|<.001
72406115|NCT00433654|144320538|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority margin is 10%.|Difference in percentages|0.5|||<|0.001||95.0|||||Farrington-Manning|||Null hypothesis: success rate MRI group \<= success rate control group - 10%||||<0.001
72406116|NCT00433654|144320539|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority margin is 10%.|Difference in percentages|1.9|||<|0.001||95.0|||||Farrington-Manning|||Null hypothesis: success rate MRI group \<= success rate control group - 10%||||<0.001
72406117|NCT00433654|144320540|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority margin is 10%.|Difference in percentages|2.1|||<|0.001||95.0|||||Farrington-Manning|||Null hypothesis: success rate MRI group \<= success rate control group - 10%||||<0.001
72406118|NCT00433654|144320541|SUPERIORITY_OR_OTHER_LEGACY||Percentage|8.3|||<|0.001|ONE_SIDED|95.0||10.7|||exact test of binomial proportions|||Null hypothesis: Percentage of subjects with complication \> 20%||10.7||<0.001
72406119|NCT03748641|144320552|SUPERIORITY||Hazard Ratio (HR)|0.729||||0.0217|TWO_SIDED|95.0|0.556|0.956|||Log Rank|||||0.956|0.556|0.0217
72406120|NCT03748641|144320553|SUPERIORITY||Hazard Ratio (HR)|0.533||||0.0014|TWO_SIDED|95.0|0.361|0.789|||Log Rank|||||0.789|0.361|0.0014
72406121|NCT05179421|144320563|OTHER|NONMEM applies nonlinear mixed effects modeling to evaluate the relationship between predicted drug concentration after administration from known pharmacokinetics and a pharmacodynamic effect, in this case being a reduction in pain from sustained heat application.|||||<|0.05|||||||Mixed Models Analysis|||Pain scores over time will first be modeled using NONMEM with derived parameters of maximum effect (Emax) and doses to produce a 50% and 90% maximum drug effect (C50 and C90, respectively), the steepness of the dose response curve (γ), and the time to peak effect. Inter-subject variability (e.g., biological variability) will evaluate additive, proportional, and exponential models. Residual intrasubject variability (e.g., noise) will typically require an additive and multiplicative error model.||||<0.05
72570297|NCT02504671|144670135|OTHER||Difference|13.5|||||TWO_SIDED|95.0|0.5|26.5|||||Week 36, ACR50. Difference to Placebo is presented for Week 36. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||26.5|0.5|
72406122|NCT00792610|144320564|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.1|STANDARD_DEVIATION|0.05|<|0.05||95.0|0.05|0.15|||t-test, 2 sided|||Chi-square analysis and Fischer's exact test were used for comparing group proportions between seropositive and seronegative participants. GMT and their 95% confidence intervals were also calculated using the software developed by Kirkman, T.W. (18) An ANOVA test was performed to compare the difference of the three groups at one, six and seven months categorized by the anti-HBs titers at 7-10 days after the booster.||.15|.05|<0.05
72406123|NCT04521166|144320578|OTHER|A linear mixed model was used to assess whether there was a difference between Settings 1 and 2.|Slope|-0.0099|STANDARD_ERROR_OF_MEAN|0.01572||0.5291|TWO_SIDED|95.0|-0.04075|0.02095||The a priori threshold for statistical significance was 0.05. P-value was adjusted for multiple comparisons using the Bonferroni correction.|Mixed Models Analysis||Setting 2 was considered as the reference and the estimate reflects whether the slope for Setting 1 is significantly different from the slope for Setting 2|||0.02095|-0.04075|0.5291
72570298|NCT02504671|144670135|OTHER||Difference|32.4|||||TWO_SIDED|95.0|16.2|48.7|||||Week 36, ACR50. Difference to Placebo is presented for Week 36. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||48.7|16.2|
72570299|NCT02504671|144670135|OTHER||Difference|16.2|||||TWO_SIDED|95.0|4.3|28.1|||||Week 36, ACR70. Difference to Placebo is presented for Week 36. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||28.1|4.3|
72570300|NCT02504671|144670135|OTHER||Difference|13.5|||||TWO_SIDED|95.0|2.5|24.5|||||Week 36, ACR70. Difference to Placebo is presented for Week 36. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||24.5|2.5|
72570301|NCT02504671|144670135|OTHER||Difference|13.5|||||TWO_SIDED|95.0|0.5|26.5|||||Week 40, ACR20. Difference to Placebo is presented for Week 40. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||26.5|0.5|
72570302|NCT02504671|144670135|OTHER||Difference|51.4|||||TWO_SIDED|95.0|34.5|68.2|||||Week 40, ACR20. Difference to Placebo is presented for Week 40. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||68.2|34.5|
72625062|NCT02908178|144779742|OTHER||Odds Ratio (OR)|1.31||||0.003|TWO_SIDED|99.0|1.04|1.65||P-value is unadjusted. Threshold for statistical significance is 0.01.|Chi-squared||Reference is no SLNB. Odds ratio accounts for matching and adjusted for subsequent mastectomy within 180 days after initial BCS, prior MRI, and radiation therapy status|Testing the association between use of sentinel lymph node biopsy (SLNB) and pain in the Aim 1 matched cohort.||1.65|1.04|.003
72406124|NCT04521166|144320578|OTHER|A linear mixed model was used to assess whether there was a difference between Setting 2 and Setting 3.|Slope|0.1329|STANDARD_ERROR_OF_MEAN|0.0174|<|0.001|TWO_SIDED|95.0|0.0988|0.1671||The a priori threshold for statistical significance was 0.05. P-value was adjusted for multiple comparisons using the Bonferroni correction.|Mixed Models Analysis||Setting 2 was considered as the reference and the estimate reflects whether the slope for Setting 3 is significantly different from the slope for Setting 2|||0.1671|0.09880|<0.001
72406125|NCT04521166|144320578|OTHER|A linear mixed model was used to assess whether there was a difference between Setting 2 and Setting 4.|Slope|0.2016|STANDARD_ERROR_OF_MEAN|0.01812|<|0.0001|TWO_SIDED|95.0|0.166|0.2371||The a priori threshold for statistical significance was 0.05. P-value was adjusted for multiple comparisons using the Bonferroni correction.|Mixed Models Analysis||Setting 2 was considered as the reference and the estimate reflects whether the slope for Setting 4 is significantly different from the slope for Setting|||0.2371|0.1660|<.0001
72522465|NCT01696396|144574493|SUPERIORITY|Analysis was not part of the formal testing|Odds Ratio (OR)|1.87||||0.23|TWO_SIDED|90.0|0.79|4.39|||Regression, Logistic|Adjusted for baseline total CDAI score and stratification factors.|An odds ratio \> 1.0 indicates a higher response rate for the abrilumab treatment group relative to placebo.|Comparisons between treatment groups were made using response rates estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||4.39|0.79|0.23
72406126|NCT04521166|144320578|OTHER|A linear mixed model was used to assess whether there was an effect of working memory on the primary outcome measure (speech intelligibility) after controlling for age and degree of hearing loss (decibel hearing level)|Slope|0.002||||0.242|TWO_SIDED|||||The a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|||A linear mixed model was used to assess whether there was an effect of working memory on the primary outcome measure (speech intelligibility) after controlling for age and degree of hearing loss (decibel hearing level)||||0.242
72522466|NCT01696396|144574493|SUPERIORITY|Analysis was not part of the formal testing|Difference in Adjusted Response Rates|15.1|||||TWO_SIDED|90.0|-6.4|31.3||||||The difference in response rates, estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||31.3|-6.4|
72522467|NCT01696396|144574494|SUPERIORITY||Odds Ratio (OR)|1.98||||0.047|TWO_SIDED|90.0|1.13|3.47|||Regression, Logistic|Adjusted for baseline CDAI score and stratification factors.|An odds ratio \> 1.0 indicates a higher response rate for the abrilumab treatment group relative to placebo.|Comparisons between treatment groups were made using response rates estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||3.47|1.13|0.047
72522468|NCT01696396|144574494|SUPERIORITY||Difference in Adjusted Response Rates|16.0|||||TWO_SIDED|90.0|2.4|27.1||||||The difference in response rates, estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||27.1|2.4|
72522469|NCT01696396|144574494|SUPERIORITY|Analysis was not part of the formal testing|Odds Ratio (OR)|1.09||||0.84|TWO_SIDED|90.0|0.52|2.29|||Regression, Logistic|Adjusted for baseline CDAI score and stratification factors.|An odds ratio \> 1.0 indicates a higher response rate for the abrilumab treatment group relative to placebo.|Comparisons between treatment groups were made using response rates estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||2.29|0.52|0.84
72522470|NCT01696396|144574494|SUPERIORITY|Analysis was not part of the formal testing|Difference in Adjusted Response Rates|1.9|||||TWO_SIDED|90.0|-15.2|15.2||||||The difference in response rates, estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||15.2|-15.2|
72522471|NCT01696396|144574494|SUPERIORITY|Analysis was not part of the formal testing|Odds Ratio (OR)|1.15||||0.78|TWO_SIDED|90.0|0.49|2.72|||Regression, Logistic|Adjusted for baseline total CDAI score and stratification factors.|An odds ratio \> 1.0 indicates a higher response rate for the abrilumab treatment group relative to placebo.|Comparisons between treatment groups were made using response rates estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||2.72|0.49|0.78
72522472|NCT01696396|144574494|SUPERIORITY|Analysis was not part of the formal testing|Difference in Adjusted Response Rates|3.1|||||TWO_SIDED|90.0|-17.4|18.3||||||The difference in response rates, estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||18.3|-17.4|
72522473|NCT01696396|144574495|SUPERIORITY||Odds Ratio (OR)|1.65||||0.34|TWO_SIDED|90.0|0.69|3.91|||Regression, Logistic|Adjusted for baseline CDAI score and stratification factors.|An odds ratio \> 1.0 indicates a higher sustained remission rate for the abrilumab treatment group relative to placebo.|Comparisons between treatment groups were made using sustained remission rates estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||3.91|0.69|0.34
72522474|NCT01696396|144574495|SUPERIORITY||Difference in Adjusted Remission Rates|5.0|||||TWO_SIDED|90.0|-3.9|11.7||||||The difference in sustained remission rates, estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||11.7|-3.9|
72570303|NCT02504671|144670135|OTHER||Difference|10.8|||||TWO_SIDED|95.0|-1.4|23.0|||||Week 40, ACR50. Difference to Placebo is presented for Week 40. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||23.0|-1.4|
72570304|NCT02504671|144670135|OTHER||Difference|29.7|||||TWO_SIDED|95.0|13.8|45.7|||||Week 40, ACR50. Difference to Placebo is presented for Week 40. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||45.7|13.8|
72570305|NCT02504671|144670135|OTHER||Difference|8.1|||||TWO_SIDED|95.0|-3.2|19.4|||||Week 40, ACR70. Difference to Placebo is presented for Week 40. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||19.4|-3.2|
72570306|NCT02504671|144670135|OTHER||Difference|13.5|||||TWO_SIDED|95.0|0.5|26.5|||||Week 40, ACR70. Difference to Placebo is presented for Week 40. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||26.5|0.5|
72522475|NCT01696396|144574495|SUPERIORITY|Analysis was not part of the formal testing|Odds Ratio (OR)|2.82||||0.078|TWO_SIDED|90.0|1.07|7.41|||Regression, Logistic|Adjusted for baseline CDAI score and stratification factors.|An odds ratio \> 1.0 indicates a higher sustained remission rate for the abrilumab treatment group relative to placebo.|Comparisons between treatment groups were made using sustained remission rates estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||7.41|1.07|0.078
72522476|NCT01696396|144574495|SUPERIORITY|Analysis was not part of the formal testing|Difference in Adjusted Remission Rates|12.8|||||TWO_SIDED|90.0|-0.6|22.6||||||The difference in sustained remission rates, estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||22.6|-0.6|
72570307|NCT02504671|144670135|OTHER||Difference|13.5|||||TWO_SIDED|95.0|0.5|26.5|||||Week 44, ACR20. Difference to Placebo is presented for Week 44. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||26.5|0.5|
72570308|NCT02504671|144670135|OTHER||Difference|51.4|||||TWO_SIDED|95.0|34.5|68.2|||||Week 44, ACR20. Difference to Placebo is presented for Week 44. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||68.2|34.5|
72570309|NCT02504671|144670135|OTHER||Difference|10.8|||||TWO_SIDED|95.0|-1.4|23.0|||||Week 44, ACR50. Difference to Placebo is presented for Week 44. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||23.0|-1.4|
72570310|NCT02504671|144670135|OTHER||Difference|35.1|||||TWO_SIDED|95.0|18.7|51.6|||||Week 44, ACR50. Difference to Placebo is presented for Week 44. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||51.6|18.7|
72570311|NCT02504671|144670135|OTHER||Difference|10.8|||||TWO_SIDED|95.0|0.8|20.8|||||Week 44, ACR70. Difference to Placebo is presented for Week 44. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||20.8|0.8|
72625063|NCT02908178|144779743|OTHER||||||<|0.001||||||P-value is unadjusted. Threshold for statistical significance is 0.01.|Chi-squared|||Testing the association between receipt of SLNB and receipt of mastectomy within 6 months of DCIS diagnosis.||||<.001
72625064|NCT02908178|144779744|OTHER|||||||0.48||||||P-value is unadjusted. Threshold for statistical significance is 0.01.|Chi-squared|||Testing the association between receipt of SLNB and receipt of radiation therapy within 9 months of DCIS diagnosis.||||.48
72406127|NCT04521166|144320578|OTHER|A linear mixed model was used to assess whether there was an effect of working memory on the primary outcome measure (speech intelligibility) after controlling for age and degree of hearing loss (decibel hearing level)|Slope|0.002||||0.242|TWO_SIDED|||||The a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|||A linear mixed model was used to assess whether there was an effect of working memory on the primary outcome measure (speech intelligibility) after controlling for age and degree of hearing loss (decibel hearing level)||||0.242
72570312|NCT02504671|144670135|OTHER||Difference|18.9|||||TWO_SIDED|95.0|6.3|31.5|||||Week 44, ACR70. Difference to Placebo is presented for Week 44. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||31.5|6.3|
72570313|NCT02504671|144670135|OTHER||Difference|13.5|||||TWO_SIDED|95.0|0.5|26.5|||||Week 48, ACR20. Difference to Placebo is presented for Week 48. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||26.5|0.5|
72522477|NCT01696396|144574495|SUPERIORITY|Analysis was not part of the formal testing|Odds Ratio (OR)|3.37||||0.083|TWO_SIDED|90.0|1.07|10.66|||Regression, Logistic|Adjusted for baseline total CDAI score and stratification factors.|An odds ratio \> 1.0 indicates a higher sustained remission rate for the abrilumab treatment group relative to placebo.|Comparisons between treatment groups were made using sustained remission rates estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||10.66|1.07|0.083
72570314|NCT02504671|144670135|OTHER||Difference|51.4|||||TWO_SIDED|95.0|37.3|70.9|||||Week 48, ACR20. Difference to Placebo is presented for Week 48. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||70.9|37.3|
72570315|NCT02504671|144670135|OTHER||Difference|13.5|||||TWO_SIDED|95.0|0.5|26.5|||||Week 48, ACR50. Difference to Placebo is presented for Week 48. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||26.5|0.5|
72570316|NCT02504671|144670135|OTHER||Difference|32.4|||||TWO_SIDED|95.0|16.2|48.7|||||Week 48, ACR50. Difference to Placebo is presented for Week 48. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||48.7|16.2|
72570317|NCT02504671|144670135|OTHER||Difference|13.5|||||TWO_SIDED|95.0|2.5|24.5|||||Week 48, ACR70. Difference to Placebo is presented for Week 48. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||24.5|2.5|
72570318|NCT02504671|144670135|OTHER||Difference|21.6|||||TWO_SIDED|95.0|8.4|34.9|||||Week 48, ACR70. Difference to Placebo is presented for Week 48. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||34.9|8.4|
72570319|NCT02504671|144670135|OTHER||Difference|13.5|||||TWO_SIDED|95.0|0.5|26.5|||||Week 52, ACR20. Difference to Placebo is presented for Week 52. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||26.5|0.5|
72570320|NCT02504671|144670135|OTHER||Difference|48.6|||||TWO_SIDED|95.0|31.7|65.6|||||Week 52, ACR20. Difference to Placebo is presented for Week 52. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||65.6|31.7|
72570321|NCT02504671|144670135|OTHER||Difference|13.5|||||TWO_SIDED|95.0|0.5|26.5|||||Week 52, ACR50. Difference to Placebo is presented for Week 52. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||26.5|0.5|
72625065|NCT02908178|144779745|OTHER||Hazard Ratio (HR)|0.88|||<|0.001|TWO_SIDED|99.0|0.73|1.05||P-value is unadjusted. Threshold for statistical significance is 0.01.|Chi-squared||Reference is no SLNB. Estimates are from matched cohort and adjusted for physician visits, any hospitalization in the 3-24 months prior to DCIS diagnosis, use of preoperative breast MRI, surgeon's operation volume, and receipt of radiation therapy.|Testing the association between use of sentinel lymph node biopsy (SLNB) and overall mortality in the Aim 2 matched cohort.||1.05|0.73|<.001
72406128|NCT04521166|144320578|OTHER|A linear mixed model was used to assess whether there was an effect of working memory on the primary outcome measure (speech intelligibility) after accounting for age and degree of hearing loss (decibel hearing level).|Slope|0.002||||0.242|TWO_SIDED|||||The a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|||A linear mixed model was used to assess whether there was an effect of working memory on the primary outcome measure (speech intelligibility) after accounting for age and degree of hearing loss (decibel hearing level).||||0.242
72522478|NCT01696396|144574495|SUPERIORITY|Analysis was not part of the formal testing|Difference in Adjusted Remission Rates|16.0|||||TWO_SIDED|90.0|-1.2|28.3||||||The difference in sustained remission rates, estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||28.3|-1.2|
72522479|NCT01696396|144574496|SUPERIORITY||Odds Ratio (OR)|1.52||||0.47|TWO_SIDED|90.0|0.59|3.93|||Regression, Logistic|Adjusted for baseline CDAI score and stratification factors.|An odds ratio \> 1.0 indicates a higher sustained remission rate for the abrilumab treatment group relative to placebo.|Comparisons between treatment groups were made using sustained remission rates estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||3.93|0.59|0.47
72522480|NCT01696396|144574496|SUPERIORITY||Difference in Adjusted Remission Rates|2.8|||||TWO_SIDED|90.0|-4.7|8.1||||||The difference in sustained remission rates, estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||8.1|-4.7|
72522481|NCT01696396|144574496|SUPERIORITY|Analysis was not part of the formal testing|Odds Ratio (OR)|2.32||||0.21|TWO_SIDED|90.0|0.77|6.98|||Regression, Logistic|Adjusted for baseline CDAI score and stratification factors.|An odds ratio \> 1.0 indicates a higher sustained remission rate for the abrilumab treatment group relative to placebo.|Comparisons between treatment groups were made using sustained remission rates estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||6.98|0.77|0.21
72406129|NCT04521166|144320578|OTHER|A linear mixed model was used to assess whether there was an effect of working memory on the primary outcome measure (speech intelligibility) after accounting for age and degree of hearing loss (decibel hearing level).|Slope|0.002||||0.242|TWO_SIDED|||||The a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|||A linear mixed model was used to assess whether there was an effect of working memory on the primary outcome measure (speech intelligibility) after accounting for age and degree of hearing loss (decibel hearing level).||||0.242
72522482|NCT01696396|144574496|SUPERIORITY|Analysis was not part of the formal testing|Difference in Adjusted Remission Rates|6.8|||||TWO_SIDED|90.0|-4.3|14.5||||||The difference in sustained remission rates, estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||14.5|-4.3|
72522483|NCT01696396|144574496|SUPERIORITY|Analysis was not part of the formal testing|Odds Ratio (OR)|2.66||||0.21|TWO_SIDED|90.0|0.75|9.45|||Regression, Logistic|Adjusted for baseline total CDAI score and stratification factors.|An odds ratio \> 1.0 indicates a higher sustained remission rate for the abrilumab treatment group relative to placebo.|Comparisons between treatment groups were made using sustained remission rates estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||9.45|0.75|0.21
72570322|NCT02504671|144670135|OTHER||Difference|24.3|||||TWO_SIDED|95.0|9.1|39.6|||||Week 52, ACR50. Difference to Placebo is presented for Week 52. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||39.6|9.1|
72570323|NCT02504671|144670135|OTHER||Difference|13.5|||||TWO_SIDED|95.0|2.5|24.5|||||Week 52, ACR70. Difference to Placebo is presented for Week 52. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||24.5|2.5|
72522484|NCT01696396|144574496|SUPERIORITY|Analysis was not part of the formal testing|Difference in Adjusted Remission Rates|8.4|||||TWO_SIDED|90.0|-6.0|17.9||||||The difference in sustained remission rates, estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||17.9|-6.0|
72522485|NCT01696396|144574497|SUPERIORITY||LS Mean Treatment Difference|-42.09||||0.006|TWO_SIDED|90.0|-67.3|-16.9|||IPW GEE Model|Adjusted for prior anti-TNF use, pre-versus post-protocol amendment 3 and baseline CDAI score.||Comparisons between treatment arms was conducted using an inverse probability weighting (IPW) generalized estimating equations (GEE) model adjusted for prior anti-TNF use, pre-versus post-protocol amendment 3 and baseline CDAI score.||-16.9|-67.3|0.006
72522486|NCT01696396|144574497|SUPERIORITY|Analysis was not part of the formal testing|LS Mean Treatment Difference|-40.79||||0.095|TWO_SIDED|90.0|-81.5|-0.5|||IPW GEE Model|Adjusted for prior anti-TNF use, pre-versus post-protocol amendment 3 and baseline CDAI score.||Comparisons between treatment arms was conducted using an inverse probability weighting (IPW) generalized estimating equations (GEE) model adjusted for prior anti-TNF use, pre-versus post-protocol amendment 3 and baseline CDAI score.||-0.5|-81.5|0.095
72570324|NCT02504671|144670135|OTHER||Difference|13.5|||||TWO_SIDED|95.0|2.5|24.5|||||Week 52, ACR70. Difference to Placebo is presented for Week 52. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||24.5|2.5|
72522487|NCT01696396|144574497|SUPERIORITY|Analysis was not part of the formal testing|LS Mean Treatment Difference|-36.84||||0.11|TWO_SIDED|90.0|-74.3|0.7|||IPW GEE Model|Adjusted for prior anti-TNF use, pre-versus post-protocol amendment 3 and baseline CDAI score.||Comparisons between treatment arms was conducted using an inverse probability weighting (IPW) generalized estimating equations (GEE) model adjusted for prior anti-TNF use, pre-versus post-protocol amendment 3 and baseline CDAI score.||0.7|-74.3|0.11
72522488|NCT01696396|144574498|SUPERIORITY||LS Mean Treatment Difference|-27.47||||0.045|TWO_SIDED|90.0|-50.0|-4.9|||IPW GEE Model|Adjusted for prior anti-TNF use, pre-versus post-protocol amendment 3 and baseline CDAI score.||Comparisons between treatment arms was conducted using an inverse probability weighting (IPW) generalized estimating equations (GEE) model adjusted for prior anti-TNF use, pre-versus post-protocol amendment 3 and baseline CDAI score.||-4.9|-50.0|0.045
72522489|NCT01696396|144574498|SUPERIORITY|Analysis was not part of the formal testing|LS Mean Treatment Difference|-23.59||||0.27|TWO_SIDED|90.0|-58.7|11.5|||IPW GEE Model|Adjusted for prior anti-TNF use, pre-versus post-protocol amendment 3 and baseline CDAI score.||Comparisons between treatment arms was conducted using an inverse probability weighting (IPW) generalized estimating equations (GEE) model adjusted for prior anti-TNF use, pre-versus post-protocol amendment 3 and baseline CDAI score.||11.5|-58.7|0.27
72522490|NCT01696396|144574498|SUPERIORITY|Analysis was not part of the formal testing|LS Mean Treatment Difference|-16.37||||0.45|TWO_SIDED|90.0|-51.8|19.1|||IPW GEE Model|Adjusted for prior anti-TNF use, pre-versus post-protocol amendment 3 and baseline CDAI score.||Comparisons between treatment arms was conducted using an inverse probability weighting (IPW) generalized estimating equations (GEE) model adjusted for prior anti-TNF use, pre-versus post-protocol amendment 3 and baseline CDAI score.||19.1|-51.8|0.45
72570325|NCT02504671|144670135|OTHER||Difference|13.5|||||TWO_SIDED|95.0|0.5|26.5|||||Week 62 (follow-up), ACR20. Difference to Placebo is presented for Week 62 (follow-up). 95% CI were constructed using asymptotic Wald confidence limits without correction.|||26.5|0.5|
72570326|NCT02504671|144670135|OTHER||Difference|40.5|||||TWO_SIDED|95.0|23.7|57.3|||||Week 62 (follow-up), ACR20. Difference to Placebo is presented for Week 62 (follow-up). 95% CI were constructed using asymptotic Wald confidence limits without correction.|||57.3|23.7|
72625066|NCT02908178|144779746|OTHER||Hazard Ratio (HR)|1.09||||0.207|TWO_SIDED|99.0|1.0|1.2||P-value is unadjusted. Threshold for statistical significance is 0.01.|Chi-squared||Reference is no SLNB. Estimates are from matched cohort and adjusted for physician visits, any hospitalization in the 3-24 months prior to DCIS diagnosis, use of preoperative breast MRI, surgeon's operation volume, and receipt of radiation therapy.|Testing the association between use of sentinel lymph node biopsy (SLNB) and any side effects in the matched Aim 2 cohort.||1.20|1.00|0.207
72406130|NCT02614547|144320580|SUPERIORITY||Least Squares Mean Difference|-12.22|STANDARD_ERROR_OF_MEAN|4.081||0.008|TWO_SIDED|95.0|-20.77|-3.67|||MMRM|||Mixed Effects Model for Repeated Measure (MMRM) used an unstructured covariance model time points within participant. Fixed effects were treatment, baseline total score, assessment time point, and time point-by-treatment.||-3.67|-20.77|0.008
72522491|NCT00394277|144574502|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.075||||0.584||95.0|0.831|1.391||All secondary comparisons were tested at a two-sided significance level of 0.05.|Cochran-Mantel-Haenszel|P-value obtained from CMH test, stratified by country and ribavirin dose strata.||This reflects the primary protocol-specified comparison (standard Pegasys induction dosing arms versus pooled Pegasys induction dosing arms). The study was designed to have at least 86% power for testing the null hypothesis of no difference between these two pooled groups, with assumed response rates of 28%, 32%, 36%, and 43% in the four treatment arms.||1.391|0.831|0.584
72522492|NCT00394277|144574503|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.039||||0.775||95.0|0.803|1.344||All secondary comparisons are tested at a two-sided significance level of 0.05.|Cochran-Mantel-Haenszel|P-value obtained from CMH test, stratified by country and ribavirin dose strata.||(PEG-IFN 180 µg + Ribavirin 1200 mg and PEG-IFN 180 µg + Ribavirin 1400/1600 mg) vs. (PEG-IFN 360/180 µg + Ribavirin 1200 mg and PEG-IFN 360/180 µg + Ribavirin 1400/1600 mg)||1.344|0.803|0.775
72570327|NCT02504671|144670135|OTHER||Difference|13.5|||||TWO_SIDED|95.0|0.5|26.5|||||Week 62 (follow-up), ACR50. Difference to Placebo is presented for Week 62 (follow-up). 95% CI were constructed using asymptotic Wald confidence limits without correction.|||26.5|0.5|
72406131|NCT02614547|144320581|SUPERIORITY||Odds Ratio (OR)|4.08||||0.198|TWO_SIDED|95.0|0.49|37.67|||Fisher Exact|||60 Hours||37.67|0.49|0.198
72570328|NCT02504671|144670135|OTHER||Difference|24.3|||||TWO_SIDED|95.0|9.1|39.6|||||Week 62 (follow-up), ACR50. Difference to Placebo is presented for Week 62 (follow-up). 95% CI were constructed using asymptotic Wald confidence limits without correction.|||39.6|9.1|
72570329|NCT02504671|144670135|OTHER||Difference|10.8|||||TWO_SIDED|95.0|-1.4|23.0|||||Week 62 (follow-up), ACR70. Difference to Placebo is presented for Week 62 (follow-up). 95% CI were constructed using asymptotic Wald confidence limits without correction.|||23.0|-1.4|
72570330|NCT02504671|144670135|OTHER||Difference|16.2|||||TWO_SIDED|95.0|2.6|29.9|||||Week 62 (follow-up), ACR70. Difference to Placebo is presented for Week 62 (follow-up). 95% CI were constructed using asymptotic Wald confidence limits without correction.|||29.9|2.6|
72570331|NCT02504671|144670136|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||Index based ACR/EULAR, Week 4. Difference to Placebo for Week 4 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
72570332|NCT02504671|144670136|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||Index based ACR/EULAR, Week 6. Difference to Placebo for Week 6 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
72406132|NCT02614547|144320581|SUPERIORITY||Odds Ratio (OR)|16.0||||0.023|TWO_SIDED|95.0|1.31|239.57|||Fisher Exact|||Day 7||239.57|1.31|0.023
72406133|NCT02614547|144320581|SUPERIORITY||Odds Ratio (OR)|6.22||||0.086|TWO_SIDED|95.0|0.7|62.08|||Fisher Exact|||Day 30||62.08|0.70|0.086
72406134|NCT02614547|144320582|SUPERIORITY||Odds Ratio (OR)|23.33||||0.008|TWO_SIDED|95.0|1.56|1152.71|||Fisher Exact|||60 Hours||1152.71|1.56|0.008
72406135|NCT02614547|144320582|SUPERIORITY|||||||0.003|||||||Fisher Exact|||Day 7||||0.003
72406136|NCT02614547|144320582|SUPERIORITY||Odds Ratio (OR)|10.5||||0.03|TWO_SIDED|95.0|1.01|140.57|||Fisher Exact|||Day 30||140.57|1.01|0.030
72522493|NCT00394277|144574504|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.004||||0.973||95.0|0.777|1.299||All secondary comparisons are tested at a two-sided significance level of 0.05.|Cochran-Mantel-Haenszel|P-value obtained from CMH test, stratified by country and ribavirin dose strata.||(PEG-IFN 180 µg + Ribavirin 1200 mg and PEG-IFN 180 µg + Ribavirin 1400/1600 mg) vs. (PEG-IFN 360/180 µg + Ribavirin 1200 mg and PEG-IFN 360/180 µg + Ribavirin 1400/1600 mg)||1.299|0.777|0.973
72522494|NCT00394277|144574505|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.008||||0.951||95.0|0.78|1.304||All secondary comparisons are tested at a two-sided significance level of 0.05.|Cochran-Mantel-Haenszel|P-value obtained from CMH test, stratified by country and ribavirin dose strata.||(PEG-IFN 180 µg + Ribavirin 1200 mg and PEG-IFN 180 µg + Ribavirin 1400/1600 mg) vs. (PEG-IFN 360/180 µg + Ribavirin 1200 mg and PEG-IFN 360/180 µg + Ribavirin 1400/1600 mg)||1.304|0.780|0.951
72522495|NCT02712008|144574507|SUPERIORITY|Analysis was performed using analysis of covariance (ANCOVA) model with baseline measurement as a covariate and treatment group as fixed factors.|Least square mean difference|-2.09||||0.1368|TWO_SIDED|95.0||0.67||Threshold for significance at 0.05 level.|ANCOVA|||||0.67|- 4.84|0.1368
72522496|NCT02712008|144574507|SUPERIORITY||Least square mean difference|0.04||||0.9716|TWO_SIDED|95.0||2.18||Threshold for significance at 0.05 level.|ANCOVA|||Analysis was performed using analysis of covariance (ANCOVA) model with baseline measurement as a covariate and treatment group as fixed factors.||2.18|- 2.10|0.9716
72522497|NCT02712008|144574508|SUPERIORITY||Least square mean difference|2.15||||0.1665|TWO_SIDED|95.0|-0.9|5.2||Threshold for significance at 0.05 level.|ANCOVA|||Analysis was performed using ANCOVA model with baseline measurement as a covariate, and treatment group and BCVA stratification variable as fixed factors.||5.20|-0.90|0.1665
72522498|NCT02712008|144574508|SUPERIORITY||Least square mean difference|1.9||||0.2223|TWO_SIDED|95.0|-1.16|4.95||Threshold for significance at 0.05 level.|ANCOVA|||Analysis was performed using ANCOVA model with baseline measurement as a covariate, and treatment group and BCVA stratification variable as fixed factors.||4.95|-1.16|0.2223
72522499|NCT02712008|144574508|SUPERIORITY||Least square mean difference|0.39||||0.7943|TWO_SIDED|95.0|-2.54|3.32||Threshold for significance at 0.05 level.|ANCOVA|||Analysis was performed using ANCOVA model with baseline measurement as a covariate, and treatment group and BCVA stratification variable as fixed factors.||3.32|-2.54|0.7943
72522500|NCT02712008|144574508|SUPERIORITY||Least square mean difference|0.66||||0.6655|TWO_SIDED|95.0|-2.35|3.67||Threshold for significance at 0.05 level.|ANCOVA|||Analysis was performed using ANCOVA model with baseline measurement as a covariate, and treatment group and BCVA stratification variable as fixed factors.||3.67|-2.35|0.6655
72522501|NCT02712008|144574508|SUPERIORITY||Least square mean difference|2.33||||0.1278|TWO_SIDED|95.0|-0.67|5.33||Threshold for significance at 0.05 level.|ANCOVA|||Analysis was performed using ANCOVA model with baseline measurement as a covariate, and treatment group and BCVA stratification variable as fixed factors.||5.33|-0.67|0.1278
72522502|NCT02712008|144574508|SUPERIORITY||Least square mean difference|-1.51||||0.3159|TWO_SIDED|-1.51|-4.47|1.45||Threshold for significance at 0.05 level.|ANCOVA|||Analysis was performed using ANCOVA model with baseline measurement as a covariate, and treatment group and BCVA stratification variable as fixed factors.||1.45|-4.47|0.3159
72625067|NCT02908178|144779746|OTHER||Hazard Ratio (HR)|1.53|||<|0.001|TWO_SIDED|99.0|1.12|2.11||P-value is unadjusted. Threshold for statistical significance is 0.01.|Chi-squared||Reference is no SLNB. Estimates are from matched cohort and adjusted for physician visits, any hospitalization in the 3-24 months prior to DCIS diagnosis, use of preoperative breast MRI, surgeon's operation volume, and receipt of radiation therapy.|Testing the association between use of sentinel lymph node biopsy (SLNB) and lymphedema related complications in the Aim 2 matched cohort.||2.11|1.12|<.001
72522503|NCT02712008|144574508|SUPERIORITY||Least square mean difference|-0.27||||0.8537|TWO_SIDED|95.0|-3.18|2.63||Threshold for significance at 0.05 level.|ANCOVA|||Analysis was performed using ANCOVA model with baseline measurement as a covariate, and treatment group and BCVA stratification variable as fixed factors.||2.63|-3.18|0.8537
72522504|NCT02712008|144574509|SUPERIORITY||Least square mean difference|-24.43||||0.1105|TWO_SIDED|95.0|-54.46|5.61||Threshold for significance at 0.05 level.|ANCOVA|||Analysis was performed using analysis of covariance (ANCOVA) model with baseline measurement as a covariate and treatment group as fixed factors.||5.61|-54.46|0.1105
72522505|NCT02712008|144574509|SUPERIORITY||Least square mean difference|-27.79||||0.0183|TWO_SIDED|95.0||||Threshold for significance at 0.05 level.|ANCOVA|||Analysis was performed using analysis of covariance (ANCOVA) model with baseline measurement as a covariate and treatment group as fixed factors.||- 4.74|- 50.83|0.0183
72522506|NCT02712008|144574510|SUPERIORITY||Least square mean difference|-55.91||||0.004|TWO_SIDED|95.0||||Threshold for significance at 0.05 level.|ANCOVA|||Analysis was performed using ANCOVA model with baseline measurement as a covariate, and treatment group and BCVA stratification variable as fixed factors.||- 18.01|- 93.81|0.0040
72522507|NCT02712008|144574510|SUPERIORITY||Least square mean difference|-40.51||||0.0365|TWO_SIDED|95.0|-78.46|-2.57||Threshold for significance at 0.05 level.|ANCOVA|||Analysis was performed using ANCOVA model with baseline measurement as a covariate, and treatment group and BCVA stratification variable as fixed factors.||-2.57|-78.46|0.0365
72522508|NCT02712008|144574510|SUPERIORITY||Least square mean difference|-37.15||||0.0454|TWO_SIDED|95.0|-73.53|-0.77||Threshold for significance at 0.05 level.|ANCOVA|||Analysis was performed using ANCOVA model with baseline measurement as a covariate, and treatment group and BCVA stratification variable as fixed factors.||-0.77|-73.53|0.0454
72522509|NCT02712008|144574510|SUPERIORITY||Least square mean difference|1.75||||0.9266|TWO_SIDED|95.0|-35.54|39.03||Threshold for significance at 0.05 level.|ANCOVA|||Analysis was performed using ANCOVA model with baseline measurement as a covariate, and treatment group and BCVA stratification variable as fixed factors.||39.03|-35.54|0.9266
72522510|NCT02712008|144574510|SUPERIORITY||Least square mean difference|-15.49||||0.4116|TWO_SIDED|95.0|-52.58|21.59||Threshold for significance at 0.05 level.|ANCOVA|||Analysis was performed using ANCOVA model with baseline measurement as a covariate, and treatment group and BCVA stratification variable as fixed factors.||21.59|-52.58|0.4116
72522511|NCT02712008|144574510|SUPERIORITY||Least square mean difference|3.36||||0.8574|TWO_SIDED|95.0|-33.42|40.14||Threshold for significance at 0.05 level.|ANCOVA|||Analysis was performed using ANCOVA model with baseline measurement as a covariate, and treatment group and BCVA stratification variable as fixed factors.||40.14|-33.42|0.8574
72570333|NCT02504671|144670136|OTHER||Difference|-2.7|||||TWO_SIDED|95.0|-7.9|2.5|||||Index based ACR/EULAR, Week 8. Difference to Placebo for Week 8 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||2.5|-7.9|
72570334|NCT02504671|144670136|OTHER||Difference|-2.7|||||TWO_SIDED|95.0|-7.9|2.5|||||Index based ACR/EULAR, Week 8. Difference to Placebo for Week 8 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||2.5|-7.9|
72570335|NCT02504671|144670136|OTHER||Difference|0.0|||||TWO_SIDED|95.0|-7.4|7.4|||||Index based ACR/EULAR, Week 8. Difference to Placebo for Week 8 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.4|-7.4|
72570336|NCT02504671|144670136|OTHER||Difference|-2.7|||||TWO_SIDED|95.0|-7.9|2.5|||||Index based ACR/EULAR, Week 12. Difference to Placebo for Week 12 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||2.5|-7.9|
72570337|NCT02504671|144670136|OTHER||Difference|-2.7|||||TWO_SIDED|95.0|-7.9|2.5|||||Index based ACR/EULAR, Week 12. Difference to Placebo for Week 12 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||2.5|-7.9|
72570338|NCT02504671|144670136|OTHER||Difference|0.0|||||TWO_SIDED|95.0|-7.4|7.4|||||Index based ACR/EULAR, Week 12. Difference to Placebo for Week 12 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.4|-7.4|
72406137|NCT02614547|144320583|SUPERIORITY||Least Squares Mean Difference|-15.86|STANDARD_ERROR_OF_MEAN|5.536||0.01|TWO_SIDED|95.0|-27.5|-4.22|||MMRM|||60 Hours: MMRM used an unstructured covariance model for time points within participant. Fixed effects were treatment, baseline total score, assessment time point, and time point-by-treatment||-4.22|-27.50|0.010
72522512|NCT02712008|144574510|SUPERIORITY||Least square mean difference|-38.9||||0.0351|TWO_SIDED|95.0|-75.06|-2.73||Threshold for significance at 0.05 level.|ANCOVA|||Analysis was performed using ANCOVA model with baseline measurement as a covariate, and treatment group and BCVA stratification variable as fixed factors.||-2.73|-75.06|0.0351
72522513|NCT02712008|144574511|SUPERIORITY||difference in percentages|-1.8||||0.7617|TWO_SIDED|95.0|-13.5|9.8||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||Analysis was performed using analysis of Cochran-Mantel-Haenszel model.||9.8|-13.5|0.7617
72522514|NCT02712008|144574511|SUPERIORITY||difference in percentages|6.1||||0.2268|TWO_SIDED|95.0||16.3||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||Analysis was performed using analysis of Cochran-Mantel-Haenszel model.||16.3|- 4.1|0.2268
72522515|NCT02712008|144574512|SUPERIORITY||difference in percentages|-1.3||||0.8896|TWO_SIDED|95.0|-20.4|17.7||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||Difference with Confidence Interval was calculated using Mantel-Haenszel weighting scheme adjusted by BCVA stratification variable.||17.7|-20.4|0.8896
72406138|NCT02614547|144320583|SUPERIORITY||Least Square Mean Difference|-15.96|STANDARD_ERROR_OF_MEAN|5.448||0.009|TWO_SIDED|95.0|-27.43|-4.5|||MMRM|||Day 7: MMRM used an unstructured covariance model for time points within participant. Fixed effects were treatment, baseline total score, assessment time point, and time point-by-treatment||-4.50|-27.43|0.009
72570339|NCT02504671|144670136|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||Index based ACR/EULAR, Week 16. Difference to Placebo for Week 16 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
72570340|NCT02504671|144670136|OTHER||Difference|13.5|||||TWO_SIDED|95.0|2.5|24.5|||||Index based ACR/EULAR, Week 16. Difference to Placebo for Week 16 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||24.5|2.5|
72522516|NCT02712008|144574512|SUPERIORITY||difference in percentages|6.4||||0.5021|TWO_SIDED|95.0|-12.6|25.5||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||Difference with Confidence Interval was calculated using Mantel-Haenszel weighting scheme adjusted by BCVA stratification variable.||25.5|-12.6|0.5021
72522517|NCT02712008|144574512|SUPERIORITY||difference in percentages|6.0||||0.5273|TWO_SIDED|95.0|-12.8|24.7||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||Difference with Confidence Interval was calculated using Mantel-Haenszel weighting scheme adjusted by BCVA stratification variable.||24.7|-12.8|0.5273
72570341|NCT02504671|144670136|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||Index based ACR/EULAR, Week 20. Difference to Placebo for Week 20 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
72570342|NCT02504671|144670136|OTHER||Difference|10.8|||||TWO_SIDED|95.0|0.8|20.8|||||Index based ACR/EULAR, Week 20. Difference to Placebo for Week 20 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||20.8|0.8|
72570343|NCT02504671|144670136|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||Index based ACR/EULAR, Week 24. Difference to Placebo for Week 24 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
72570344|NCT02504671|144670136|OTHER||Difference|8.1|||||TWO_SIDED|95.0|-0.7|16.9|||||Index based ACR/EULAR, Week 24. Difference to Placebo for Week 24 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||16.9|-0.7|
72570345|NCT02504671|144670136|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||Index based ACR/EULAR, Week 28. Difference to Placebo for Week 28 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
72570346|NCT02504671|144670136|OTHER||Difference|10.8|||||TWO_SIDED|95.0|0.8|20.8|||||Index based ACR/EULAR, Week 28. Difference to Placebo for Week 28 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||20.8|0.8|
72570347|NCT02504671|144670136|OTHER||Difference|13.5|||||TWO_SIDED|95.0|2.5|24.5|||||Index based ACR/EULAR, Week 32. Difference to Placebo for Week 32 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||24.5|2.5|
72570348|NCT02504671|144670136|OTHER||Difference|8.1|||||TWO_SIDED|95.0|-0.7|16.9|||||Index based ACR/EULAR, Week 32. Difference to Placebo for Week 32 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||16.9|-0.7|
72522518|NCT02712008|144574512|SUPERIORITY||difference in percentages|-1.5||||0.8683|TWO_SIDED|95.0|-19.7|16.6||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||Difference with Confidence Interval was calculated using Mantel-Haenszel weighting scheme adjusted by BCVA stratification variable.||16.6|-19.7|0.8683
72406139|NCT02614547|144320583|SUPERIORITY||Least Square Mean Difference|-15.07|STANDARD_ERROR_OF_MEAN|5.213||0.01|TWO_SIDED|95.0|-26.05|-4.09|||MMRM|||Day 30: MMRM used an unstructured covariance model for time points within participant. Fixed effects were treatment, baseline total score, assessment time point, and time point-by-treatment||-4.09|-26.05|0.010
72406140|NCT02614547|144320584|SUPERIORITY||Odds Ratio (OR)|7.0||||0.08|TWO_SIDED|95.0|0.73|90.81|||Fisher Exact|||60 Hours||90.81|0.73|0.080
72522519|NCT02712008|144574512|SUPERIORITY||difference in percentages|8.8||||0.3546|TWO_SIDED|95.0|-9.8|27.4||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||Difference with Confidence Interval was calculated using Mantel-Haenszel weighting scheme adjusted by BCVA stratification variable.||27.4|-9.8|0.3546
72522520|NCT02712008|144574512|SUPERIORITY||difference in percentages|0.2||||0.9801|TWO_SIDED|95.0|-19.0|19.5||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||Difference with Confidence Interval was calculated using Mantel-Haenszel weighting scheme adjusted by BCVA stratification variable.||19.5|-19.0|0.9801
72522521|NCT02712008|144574512|SUPERIORITY||difference in percentages|8.8||||0.3528|TWO_SIDED|95.0|-9.9|27.4||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||Difference with Confidence Interval was calculated using Mantel-Haenszel weighting scheme adjusted by BCVA stratification variable.||27.4|-9.9|0.3528
72522522|NCT02043509|144574522|SUPERIORITY||Adjusted odds ratio|2.7|||||TWO_SIDED|95.0|0.93|9.35|||||Odds ratios are model-based (adjusted by site and gestation at randomization). 95% profile confidence intervals are reported.|||9.35|0.93|
72522523|NCT02043509|144574523|SUPERIORITY||Adjusted odds ratio|1.03|||||TWO_SIDED|95.0|0.61|1.75|||||Odds ratios are model-based (adjusted by site and gestation at randomization). 95% profile confidence intervals are reported.|||1.75|0.61|
72522524|NCT02043509|144574524|SUPERIORITY||Adjusted odds ratio|1.34|||||TWO_SIDED|95.0|0.79|2.31|||||Odds ratios are model-based (adjusted by site and gestation at randomization). 95% profile confidence intervals are reported.|||2.31|0.79|
72522525|NCT02043509|144574525|SUPERIORITY||Adjusted odds ratio|1.67|||||TWO_SIDED|95.0|0.72|4.03|||||Odds ratios are model-based (adjusted by site and gestation at randomization). 95% profile confidence intervals are reported.|||4.03|0.72|
72522526|NCT02043509|144574526|SUPERIORITY||Adjusted odds ratio|2.11|||||TWO_SIDED|95.0|0.89|5.46|||||Odds ratios are model-based (adjusted by site and gestation at randomization). 95% profile confidence intervals are reported.|||5.46|0.89|
72522527|NCT02043509|144574527|SUPERIORITY||Adjusted odds ratio|3.16|||||TWO_SIDED|95.0|1.14|10.69|||||Odds ratios are model-based (adjusted by site and gestation at randomization). 95% profile confidence intervals are reported.|||10.69|1.14|
72522528|NCT02043509|144574528|SUPERIORITY||Adjusted odds ratio|3.28|||||TWO_SIDED|95.0|0.9|17.36|||||Odds ratios are model-based (adjusted by site and gestation at randomization). 95% profile confidence intervals are reported.|||17.36|0.90|
72570349|NCT02504671|144670136|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||Index based ACR/EULAR, Week 36. Difference to Placebo for Week 36 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
72570350|NCT02504671|144670136|OTHER||Difference|10.8|||||TWO_SIDED|95.0|0.8|20.8|||||Index based ACR/EULAR, Week 36. Difference to Placebo for Week 36 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||20.8|0.8|
72406141|NCT02614547|144320584|SUPERIORITY||Odds Ratio (OR)|16.0||||0.023|TWO_SIDED|95.0|1.31|239.57|||Fisher Exact|||Day 7||239.57|1.31|0.023
72406142|NCT02614547|144320584|SUPERIORITY||Odds Ratio (OR)|10.67||||0.03|TWO_SIDED|95.0|1.04|142.2|||Fisher Exact|||Day 30||142.20|1.04|0.030
72522529|NCT02043509|144574529|SUPERIORITY|||||||0.118|||||||Mann-Whitney U-test|||||||0.118
72522530|NCT03189563|144574536|SUPERIORITY|||||||0.3656||||||p-value is from ANCOVA model adjusted for baseline motor MDS-UPDRS total score. All statistical tests for efficacy are two-sided tests, with α=0.05.|ANCOVA|||Change from baseline is based on subjects with paired values.||||0.3656
72522531|NCT03189563|144574536|SUPERIORITY|||||||0.3119||||||p-value is from ANCOVA model adjusted for baseline motor MDS-UPDRS total score. All statistical tests for efficacy are two-sided tests, with α=0.05.|ANCOVA|||Change from baseline is based on subjects with paired values.||||0.3119
72522532|NCT03189563|144574537|SUPERIORITY|||||||0.147||||||p-value is from ANCOVA model adjusted for baseline MDS-UPDRS total score. All statistical tests for efficacy are two-sided tests, with α=0.05.|ANCOVA|||Change from baseline is based on subjects with paired values.||||0.1470
72522533|NCT03189563|144574537|SUPERIORITY|||||||0.252||||||p-value is from ANCOVA model adjusted for baseline MDS-UPDRS total score. All statistical tests for efficacy are two-sided tests, with α=0.05.|ANCOVA|||Change from baseline is based on subjects with paired values.||||0.2520
72522534|NCT03189563|144574538|SUPERIORITY|||||||0.1528||||||"p-value is from ANCOVA model adjusted for baseline MDS-UPDRS part 1 subscale score.~All statistical tests for efficacy are two-sided tests, with α=0.05."|ANCOVA|||Change from baseline is based on subjects with paired values.||||0.1528
72406143|NCT02614547|144320585|SUPERIORITY||Least Squares Mean Difference|-6.05|STANDARD_ERROR_OF_MEAN|2.466||0.025|TWO_SIDED|95.0|-11.24|-0.86|||MMRM|||60 Hours: MMRM used an unstructured covariance model for time points within participant. Fixed effects were treatment, baseline total score, assessment time point, and time point-by-treatment.||-0.86|-11.24|0.025
72406144|NCT02614547|144320585|SUPERIORITY||Least Squares Mean Difference|-6.46|STANDARD_ERROR_OF_MEAN|2.427||0.016|TWO_SIDED|95.0|-11.57|-1.34|||MMRM|||Day 7: MMRM used an unstructured covariance model for time points within participant. Fixed effects were treatment, baseline total score, assessment time point, and time point-by-treatment.||-1.34|-11.57|0.016
72522535|NCT03189563|144574538|SUPERIORITY|||||||0.6146||||||"p-value is from ANCOVA model adjusted for baseline MDS-UPDRS part 1 subscale score.~All statistical tests for efficacy are two-sided tests, with α=0.05."|ANCOVA|||Change from baseline is based on subjects with paired values.||||0.6146
72522536|NCT03189563|144574539|SUPERIORITY|||||||0.5691||||||p-value is from ANCOVA model adjusted for baseline S\&E scale total score. All statistical tests for efficacy are two-sided tests, with α=0.05.|ANCOVA|||Change from baseline is based on subjects with paired values.||||0.5691
72522537|NCT03189563|144574539|SUPERIORITY|||||||0.1309||||||p-value is from ANCOVA model adjusted for baseline S\&E scale total score. All statistical tests for efficacy are two-sided tests, with α=0.05.|ANCOVA|||Change from baseline is based on subjects with paired values.||||0.1309
72522538|NCT03189563|144574540|SUPERIORITY|||||||0.7913||||||p-value is from ANCOVA model adjusted for baseline PDQ-39 summary index. All statistical tests for efficacy are two-sided tests, with α=0.05.|ANCOVA|||Change from baseline is based on subjects with paired values.||||0.7913
72406145|NCT02614547|144320585|SUPERIORITY||Least Squares Mean Difference|-6.8|STANDARD_ERROR_OF_MEAN|2.568||0.018|TWO_SIDED|95.0|-12.25|-1.35|||MMRM|||Day 30: MMRM used an unstructured covariance model for time points within participant. Fixed effects were treatment, baseline total score, assessment time point, and time point-by-treatment.||-1.35|-12.25|0.018
72406146|NCT02614547|144320587|SUPERIORITY||Least Squares Mean Difference|1.87|STANDARD_ERROR_OF_MEAN|2.461||0.457|TWO_SIDED|95.0|-3.3|7.04|||ANCOVA|||60 Hours||7.04|-3.30|0.457
72406147|NCT02614547|144320587|SUPERIORITY||Least Square Mean|-1.47|STANDARD_ERROR_OF_MEAN|-1.47||0.613|TWO_SIDED|95.0|-7.5|4.55|||ANCOVA|||Day 7||4.55|-7.50|0.613
72522539|NCT03189563|144574540|SUPERIORITY|||||||0.9399||||||p-value is from ANCOVA model adjusted for baseline PDQ-39 summary index. All statistical tests for efficacy are two-sided tests, with α=0.05.|ANCOVA|||Change from baseline is based on subjects with paired values.||||0.9399
72522540|NCT03189563|144574541|SUPERIORITY|||||||0.4978||||||p-value is from ANCOVA model adjusted for baseline H\&Y scale total score. All statistical tests for efficacy are two-sided tests, with α=0.05.|ANCOVA|||Change from baseline is based on subjects with paired values.||||0.4978
72406148|NCT02614547|144320587|SUPERIORITY||Least Square Mean|-2.1|STANDARD_ERROR_OF_MEAN|2.871||0.474|TWO_SIDED|95.0|-8.13|3.93|||ANCOVA|||Day 30||3.93|-8.13|0.474
72522541|NCT03189563|144574541|SUPERIORITY|||||||0.888||||||p-value is from ANCOVA model adjusted for baseline H\&Y scale total score. All statistical tests for efficacy are two-sided tests, with α=0.05.|ANCOVA|||Change from baseline is based on subjects with paired values.||||0.8880
72522542|NCT03189563|144574542|SUPERIORITY|||||||0.5755||||||"p-value is from ANCOVA model adjusted for baseline MDS-UPDRS part 2 subscale score.~All statistical tests for efficacy are two-sided tests, with α=0.05."|ANCOVA|||Change from baseline is based on subjects with paired values.||||0.5755
72522543|NCT03189563|144574542|SUPERIORITY|||||||0.1517||||||"p-value is from ANCOVA model adjusted for baseline MDS-UPDRS part 2 subscale score.~All statistical tests for efficacy are two-sided tests, with α=0.05."|ANCOVA|||Change from baseline is based on subjects with paired values.||||0.1517
72522544|NCT03189563|144574543|SUPERIORITY|||||||0.2095||||||"p-value is from ANCOVA model adjusted for baseline MDS-UPDRS part 3 subscale score.~All statistical tests for efficacy are two-sided tests, with α=0.05."|ANCOVA|||Change from baseline is based on subjects with paired values.||||0.2095
72570351|NCT02504671|144670136|OTHER||Difference|8.1|||||TWO_SIDED|95.0|-0.7|16.9|||||Index based ACR/EULAR, Week 36. Difference to Placebo for Week 36 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||16.9|-0.7|
72570352|NCT02504671|144670136|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||Index based ACR/EULAR, Week 40. Difference to Placebo for Week 40 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
72406149|NCT05619692|144320650|SUPERIORITY||Difference in LS Means|1.5|STANDARD_ERROR_OF_MEAN|1.11||0.1642|TWO_SIDED|95.0|-0.64|3.73||The p-value was obtained using MMRM model which included treatment, visit, treatment-by-visit interaction as categorical covariates, and WAIS-IV at baseline as continuous covariates.|MRMM||Difference was calculated as SAGE-718 - placebo.|||3.73|-0.64|0.1642
72406150|NCT01494610|144320760|NON_INFERIORITY_OR_EQUIVALENCE|Estimates of within-par. coefficient of variation for AUC(0-tau) of FP and weighted mean (0-12 h) serum cortisol from previous studies showed that a sample size of 52 par. would have approximately 90% power to demonstrate biocomparability with respect to the two co-primary endpoints. The study was powered on the analysis of asthma and COPD par. as a combined group. A two one-sided t-test procedure with α=0.05 for each one-sided test was used. Biocomparability limits of 0.8 and 1.25 were used.|Ratio of adjusted geometric means|1.508|||||TWO_SIDED|90.0|1.366|1.665|||||Data reflect Asthma + COPD participants. The ratio of adjusted geometric means is a comparision of treatment administered by the capsule-based inhaler and the MDPI.|||1.665|1.366|
72522545|NCT03189563|144574543|SUPERIORITY|||||||0.6094||||||"p-value is from ANCOVA model adjusted for baseline MDS-UPDRS part 3 subscale score.~All statistical tests for efficacy are two-sided tests, with α=0.05."|ANCOVA|||Change from baseline is based on subjects with paired values.||||0.6094
72522546|NCT03189563|144574544|SUPERIORITY|||||||0.226||||||"p-value is from ANCOVA model adjusted for baseline MDS-UPDRS part 4 subscale score.~All statistical tests for efficacy are two-sided tests, with α=0.05."|ANCOVA|||Change from baseline is based on subjects with paired values.||||0.2260
72522547|NCT03189563|144574544|SUPERIORITY|||||||0.226||||||p-value is from ANCOVA model adjusted for baseline MDS-UPDRS part 4 subscale score All statistical tests for efficacy are two-sided tests, with α=0.05.|ANCOVA|||Change from baseline is based on subjects with paired values.||||0.2260
72522548|NCT03189563|144574545|SUPERIORITY|||||||0.8274||||||p-value is from ANCOVA model adjusted for baseline CGI-S score. All statistical tests for efficacy are two-sided tests, with α=0.05.|ANCOVA|||Change from baseline is based on subjects with paired values.||||0.8274
72570353|NCT02504671|144670136|OTHER||Difference|10.8|||||TWO_SIDED|95.0|0.8|20.8|||||Index based ACR/EULAR, Week 40. Difference to Placebo for Week 40 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||20.8|0.8|
72570354|NCT02504671|144670136|OTHER||Difference|8.1|||||TWO_SIDED|95.0|-0.7|16.9|||||Index based ACR/EULAR, Week 40. Difference to Placebo for Week 40 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||16.9|-0.7|
72570355|NCT02504671|144670136|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||Index based ACR/EULAR, Week 44. Difference to Placebo for Week 44 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
72522549|NCT03189563|144574545|SUPERIORITY|||||||0.3416||||||p-value is from ANCOVA model adjusted for baseline CGI-S score. All statistical tests for efficacy are two-sided tests, with α=0.05.|ANCOVA|||Change from baseline is based on subjects with paired values.||||0.3416
72522550|NCT03189563|144574546|SUPERIORITY|||||||0.4052||||||P-value is from ANCOVA model. All statistical tests for efficacy are two-sided tests, with α=0.05.|ANCOVA|||||||0.4052
72570356|NCT02504671|144670136|OTHER||Difference|8.1|||||TWO_SIDED|95.0|-0.7|16.9|||||Index based ACR/EULAR, Week 44. Difference to Placebo for Week 44 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||16.9|-0.7|
72406151|NCT01494610|144320760|NON_INFERIORITY_OR_EQUIVALENCE|Estimates of within-par. coefficient of variation for AUC(0-tau) of FP and weighted mean (0-12 h) serum cortisol from previous studies showed that a sample size of 52 par. would have approximately 90% power to demonstrate biocomparability with respect to the two co-primary endpoints. The study was powered on the analysis of asthma and COPD par. as a combined group. Biocomparability limits of 0.8 and 1.25 were used.|Ratio of adjusted geometric means|1.598|||||TWO_SIDED|90.0|1.369|1.864|||||Data reflect participants with asthma only. The ratio of adjusted geometric means is a comparision of treatment administered by the capsule-based inhaler and the MDPI.|||1.864|1.369|
72406152|NCT01494610|144320760|NON_INFERIORITY_OR_EQUIVALENCE|Estimates of within-par. coefficient of variation for AUC(0-tau) of FP and weighted mean (0-12 h) serum cortisol from previous studies showed that a sample size of 52 par. would have approximately 90% power to demonstrate biocomparability with respect to the two co-primary endpoints. The study was powered on the analysis of asthma and COPD par. as a combined group. A two one-sided t-test procedure with α=0.05 for each one-sided test was used. Biocomparability limits of 0.8 and 1.25 were used.|Ratio of adjusted geometric means|1.421|||||TWO_SIDED|90.0|1.274|1.584|||||Data reflect participants with COPD only. The ratio of adjusted geometric means is the comparision of treatment administered by the capsule-based inhaler and the MDPI.|||1.584|1.274|
72406153|NCT01494610|144320761|NON_INFERIORITY_OR_EQUIVALENCE|Estimates of within-par. coefficient of variation for AUC(0-tau) of FP and weighted mean (0-12 h) serum cortisol from previous studies showed that a sample size of 52 par. would have approximately 90% power to demonstrate biocomparability with respect to the two co-primary endpoints. The study was powered on the analysis of asthma and COPD par. as a combined group. A two one-sided t-test procedure with α=0.05 for each one-sided test was used. Biocomparability limits of 0.8 and 1.25 were used.|Ratio of adjusted geometric means|0.928|||||TWO_SIDED|90.0|0.886|0.971|||||Data reflect Asthma + COPD participants. The ratio of adjusted geometric means is the comparision of treatment administered by the capsule-based inhaler and the MDPI.|||0.971|0.886|
72406154|NCT01494610|144320761|NON_INFERIORITY_OR_EQUIVALENCE|Estimates of within-par. coefficient of variation for AUC(0-tau) of FP and weighted mean (0-12 h) serum cortisol from previous studies showed that a sample size of 52 par. would have approximately 90% power to demonstrate biocomparability with respect to the two co-primary endpoints. The study was powered on the analysis of asthma and COPD par. as a combined group. A two one-sided t-test procedure with α=0.05 for each one-sided test was used. Biocomparability limits of 0.8 and 1.25 were used.|Ratio of adjusted geometric means|0.892|||||TWO_SIDED|90.0|0.848|0.939|||||Data reflect participants with asthma only. The ratio of adjusted geometric means is the comparision of treatment administered by the capsule-based inhaler and the MDPI.|||0.939|0.848|
72406155|NCT01494610|144320761|NON_INFERIORITY_OR_EQUIVALENCE|Estimates of within-par. coefficient of variation for AUC(0-tau) of FP and weighted mean (0-12 h) serum cortisol from previous studies showed that a sample size of 52 par. would have approximately 90% power to demonstrate biocomparability with respect to the two co-primary endpoints. The study was powered on the analysis of asthma and COPD par. as a combined group. A two one-sided t-test procedure with α=0.05 for each one-sided test was used. Biocomparability limits of 0.8 and 1.25 were used.|Ratio of adjusted geometric means|0.966|||||TWO_SIDED|90.0|0.889|1.049|||||Data reflect participants with COPD only. The ratio of adjusted geometric means is the comparision of treatment administered by the capsule-based inhaler and the MDPI.|||1.049|0.889|
72406156|NCT00167934|144320854|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||ANCOVA|||||||< 0.0001
72522551|NCT03189563|144574546|SUPERIORITY|||||||0.2643||||||P-value is from ANCOVA model. All statistical tests for efficacy are two-sided tests, with α=0.05.|ANCOVA|||||||0.2643
72570357|NCT02504671|144670136|OTHER||Difference|10.8|||||TWO_SIDED|95.0|0.8|20.8|||||Index based ACR/EULAR, Week 44. Difference to Placebo for Week 44 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||20.8|0.8|
72406157|NCT00167934|144320855|SUPERIORITY_OR_OTHER_LEGACY|||||||0.04|TWO_SIDED||||||ANCOVA|||||||0.04
72522552|NCT02443155|144574600|SUPERIORITY||Treatment ratio|1.48|||=|0.0017|TWO_SIDED|95.0|1.16|1.89|||Mixed model repeated measurements||NNC0114-0006 + liraglutide / Placebo|Ratio of week 54 to baseline are analysed using mixed model for repeated measurements (MMRM) with an unstructured covariance matrix. Treatment, stratum and sex as factors and log baseline value and age as covariates, including the interaction between visit and all variables.||1.89|1.16|=0.0017
72522553|NCT02443155|144574600|SUPERIORITY||Treatment Ratio|1.23|||=|0.0927|TWO_SIDED|95.0|0.97|1.57|||Mixed model repeated measurements|||Ratio of week 54 to baseline are analysed using MMRM with an unstructured covariance matrix. Treatment, stratum and sex as factors and log baseline value and age as covariates, including the interaction between visit and all variables.||1.57|0.97|=0.0927
72570358|NCT02504671|144670136|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||Index based ACR/EULAR, Week 48. Difference to Placebo for Week 48 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
72570359|NCT02504671|144670136|OTHER||Difference|10.8|||||TWO_SIDED|95.0|0.8|20.8|||||Index based ACR/EULAR, Week 48. Difference to Placebo for Week 48 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||20.8|0.8|
72570360|NCT02504671|144670136|OTHER||Difference|8.1|||||TWO_SIDED|95.0|-0.7|16.9|||||Index based ACR/EULAR, Week 48. Difference to Placebo for Week 48 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||16.9|-0.7|
72570361|NCT02504671|144670136|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||Index based ACR/EULAR, Week 52. Difference to Placebo for Week 52 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
72570362|NCT02504671|144670136|OTHER||Difference|13.5|||||TWO_SIDED|95.0|2.5|24.5|||||Index based ACR/EULAR, Week 52. Difference to Placebo for Week 52 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||24.5|2.5|
72570363|NCT02504671|144670136|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||Index based ACR/EULAR, Week 52. Difference to Placebo for Week 52 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
72522554|NCT02443155|144574600|SUPERIORITY||Treatment Ratio|1.12|||=|0.378|TWO_SIDED|95.0|0.87|1.42|||Mixed model repeated measurements|||Ratio of week 54 to baseline are analysed using MMRM with an unstructured covariance matrix. Treatment, stratum and sex as factors and log baseline value and age as covariates, including the interaction between visit and all variables.||1.42|0.87|=0.3780
72522555|NCT02443155|144574600|SUPERIORITY||Treatment ratio|1.2|||=|0.1377|TWO_SIDED|95.0|0.94|1.53|||Mixed model repeated measurements|||Ratio of week 54 to baseline are analysed using MMRM with an unstructured covariance matrix. Treatment, stratum and sex as factors and log baseline value and age as covariates, including the interaction between visit and all variables.||1.53|0.94|=0.1377
72522556|NCT02443155|144574600|SUPERIORITY||Treatment ratio|1.33|||=|0.0214|TWO_SIDED|95.0|1.04|1.69|||Mixed model repeated measurements|||Ratio of week 54 to baseline are analysed using MMRM with an unstructured covariance matrix. Treatment, stratum and sex as factors and log baseline value and age as covariates, including the interaction between visit and all variables.||1.69|1.04|=0.0214
72522557|NCT02443155|144574600|SUPERIORITY||Treatmrnt ratio|1.1|||=|0.4187|TWO_SIDED|95.0|0.87|1.41|||Mixed model repeated measurements|||Ratio of week 54 to baseline are analysed using MMRM with an unstructured covariance matrix. Treatment, stratum and sex as factors and log baseline value and age as covariates, including the interaction between visit and all variables.||1.41|0.87|=0.4187
72522558|NCT00106249|144574722|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
72522559|NCT00106249|144574723|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
72522560|NCT02037204|144574743|NON_INFERIORITY|A repeated-measures analysis of variance was used to test for differences in clinical outcome between baseline and 3, and 18 months after surgery.|||||<|0.05|||||||ANOVA|||A repeated-measures analysis of variance was used to test for differences in clinical outcome between baseline and 3, and 18 months after surgery.||||<0.05
72522561|NCT00524043|144574754|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.8|STANDARD_ERROR_OF_MEAN|4.2||0.504||95.0|-5.47|11.09||Based on ANCOVA model with treatment (Placebo, Paliperidone ER 1.5 mg, and Paliperidone ER 6 mg) and country as factors, and baseline value as a covariate. Comparison with placebo was without multiplicity adjustment.|ANCOVA|||Sample size estimation was based on the assumption that the difference between the paliperidone ER 1.5 mg dose group and the placebo group in the mean change in PANSS total score from baseline to end point was 11 points with a within-group standard deviation of 20 points. It was calculated that 65 patients were needed per treatment group to detect a statistically significant treatment difference between the paliperidone ER 1.5 mg dose group and the placebo group with a power of 87.5%.||11.09|-5.47|0.504
72522562|NCT00524043|144574754|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.3|STANDARD_ERROR_OF_MEAN|4.15||0.431||95.0|-11.46|4.9||Based on ANCOVA model with treatment (Placebo, Paliperidone ER 1.5 mg, and Paliperidone ER 6 mg) and country as factors, and baseline value as a covariate. Comparison with placebo was without multiplicity adjustment.|ANCOVA|Paliperidone ER 6 mg was used for assay sensitivity||||4.90|-11.46|0.431
72522563|NCT00524043|144574755|SUPERIORITY_OR_OTHER|||||||0.626||95.0||||Based on ANCOVA model on ranks with treatment (Placebo, Paliperidone ER 1.5 mg, and Paliperidone ER 6 mg) and country as factors, and baseline value as a covariate. Comparison with placebo was without multiplicity adjustment.|ANCOVA|||||||0.626
72522564|NCT00524043|144574756|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.4|STANDARD_ERROR_OF_MEAN|2.69||0.87||95.0|-4.86|5.74||Based on ANCOVA model with treatment (placebo, paliperidone ER 1.5 mg, and paliperidone ER 6 mg) and country as factors, and baseline value as a covariate. Comparison with placebo was without multiplicity adjustment.|ANCOVA|||||5.74|-4.86|0.870
72522565|NCT00524043|144574757|SUPERIORITY_OR_OTHER|||||||0.126||95.0||||Based on ANCOVA model with treatment (placebo, paliperidone ER 1.5 mg, and paliperidone ER 6 mg) and country as factors and baseline value as a covariate. Comparison with placebo was without multiplicity adjustment.|ANCOVA|||||||0.126
72570364|NCT02504671|144670136|OTHER||Difference|8.1|||||TWO_SIDED|95.0|-0.7|16.9|||||Index based ACR/EULAR, Week 62 (follow-up). Difference to Placebo for Week 62 (follow-up) is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||16.9|-0.7|
72570365|NCT02504671|144670136|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||Index based ACR/EULAR, Week 62 (follow-up). Difference to Placebo for Week 62 (follow-up) is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
72522566|NCT00524043|144574758|SUPERIORITY_OR_OTHER|||||||0.691||95.0||||Based on ANCOVA model with treatment (placebo, paliperidone ER 1.5 mg, and paliperidone ER 6 mg) and country as factors and baseline value as a covariate. Comparison with placebo was without multiplicity adjustment.|ANCOVA|||||||0.691
72522567|NCT00927576|144574790|NON_INFERIORITY_OR_EQUIVALENCE|Power analysis of the results showed a 95% chance of finding a p\<0.05 difference in 166 subjects and a 99% chance of finding a p \<0.05 difference in 230 subjects in comparison of Group 1 controls and sTBI patients.|Difference in z-score, sTBI vs. controls|2.04|||<|0.001|TWO_SIDED||||||ANOVA|for repeated measures with effect sizes (omega squared).||The null hypotheses was that the severe TBI group would not differ from the control group in SRT latencies.||||< 0.001
72522568|NCT00927576|144574790|NON_INFERIORITY_OR_EQUIVALENCE|Power analysis of controls (i.e., with z-score = 0) showed a 95% chance of detecting a p \< 0.05 significance level for z-scores exceeding 0.54 in the mild TBI patient group..|z-score difference between groups|-0.3||||0.5|TWO_SIDED|||||The P-value reflects the likelihood of detection a difference of the magnitude observed.|ANOVA|||The null hypothesis was that the mild TBI group would not differ in age-corrected z-score from that of a control subjects in the large control group.||||.50
72522569|NCT04211961|144574813|SUPERIORITY|||||||0.3|||||||Wilcoxon (Mann-Whitney)|||||||0.3
72406158|NCT04951622|144320864|SUPERIORITY||Difference of LS Means|-1.45|STANDARD_ERROR_OF_MEAN|0.47|=|0.002|TWO_SIDED|95.0|-2.38|-0.52|||mixed effects model for repeated measure|||||-0.52|-2.38|=0.002
72570366|NCT02504671|144670136|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||Index based ACR/EULAR, Week 2. Difference to Placebo for Week 2 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
72570367|NCT02504671|144670136|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||Index based ACR/EULAR, Week 4. Difference to Placebo for Week 4 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
72570368|NCT02504671|144670136|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||Index based ACR/EULAR, Week 6. Difference to Placebo for Week 6 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
72570369|NCT02504671|144670136|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||Index based ACR/EULAR, Week 6. Difference to Placebo for Week 6 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
72522570|NCT04211961|144574814|SUPERIORITY||||||>|0.9|||||||Fisher Exact|||||||>0.9
72522571|NCT04211961|144574815|SUPERIORITY|||||||0.3|||||||Fisher Exact|||||||0.3
72522572|NCT04211961|144574816|SUPERIORITY|||||||0.5|||||||Chi-squared|||||||0.5
72522573|NCT04211961|144574818|SUPERIORITY|||||||0.6|||||||Wilcoxon (Mann-Whitney)|||||||0.6
72522574|NCT04211961|144574819|SUPERIORITY|||||||0.2|||||||Wilcoxon (Mann-Whitney)|||||||0.2
72522575|NCT04211961|144574820|SUPERIORITY|||||||0.2|||||||Wilcoxon (Mann-Whitney)|||||||0.2
72522576|NCT04211961|144574822|SUPERIORITY|||||||0.024|||||||Wilcoxon (Mann-Whitney)|||||||0.024
72522577|NCT04211961|144574823|SUPERIORITY|||||||0.9|||||||Fisher Exact|||||||0.9
72522578|NCT04211961|144574824|SUPERIORITY||||||>|0.9|||||||Fisher Exact|||||||>0.9
72522579|NCT04211961|144574825|SUPERIORITY||||||>|0.9|||||||Fisher Exact|||||||>0.9
72522580|NCT04211961|144574826|SUPERIORITY||||||>|0.9|||||||Fisher Exact|||||||>0.9
72522581|NCT02773368|144574850|NON_INFERIORITY|Non-inferiority of IDegLira was considered confirmed if the upper limit of the two-sided 95% confidence interval (CI) for mean treatment difference (IDegLira minus IGlar) was strictly below 0.3%.|Treatment Contrast|-0.34|||||TWO_SIDED|95.0|-0.48|-0.2|||ANCOVA||IDegLira minus IGlar|Analysis was based on ANCOVA model with treatment, pre-trial OAD, region as factors and baseline HbA1c as covariate. Data obtained after premature treatment discontinuation are included in the analysis. Missing data was imputed using unconditional reference based multiple imputation including data obtained after premature treatment discontinuation. The non-inferiority margin of 0.3 % was added to the end-of-treatment value for prematurely discontinued and withdrawn from trial IDegLira subjects.||-0.20|-0.48|
72522582|NCT02773368|144574850|SUPERIORITY|Superiority of IDegLira was considered confirmed if the test procedure was not stopped (i.e. non-inferiority of IDegLira was confirmed for change from baseline in HbA1c; and superiority of IDegLira was confirmed for weight change and the number of treatment-emergent severe or BG confirmed symptomatic hypoglycaemic episodes) and if the upper limit of the two-sided 95% CI for the mean treatment difference (IDegLira minus IGlar) in change from baseline in HbA1c was strictly below 0%.|Treatment Contrast|-0.36|||||TWO_SIDED|95.0|-0.5|-0.21|||ANCOVA||IDegLira minus IGlar|This endpoint was analysed using an ANCOVA model with treatment, pre-trial OAD and region as factors and corresponding baseline value as covariate. Data obtained after premature treatment discontinuation were included in the analysis. Missing data were imputed using unconditional reference based multiple imputation including data obtained after premature treatment discontinuation.||-0.21|-0.50|
72522583|NCT02773368|144574851|SUPERIORITY|Superiority of IDegLira was considered confirmed if the test procedure was not stopped (i.e. non-inferiority of IDegLira was confirmed for change from baseline in HbA1c) and if the upper limit of the two-sided 95% CI for the mean treatment difference (IDegLira minus IGlar) in change from baseline in body weight was strictly below 0 kg.|Treatment Contrast|-1.92|||||TWO_SIDED|95.0|-2.64|-1.19|||ANCOVA||IDegLira minus IGlar|This endpoint was analysed using an ANCOVA model with treatment, pre-trial OAD and region as factors and corresponding baseline weight as covariate. Data obtained after premature treatment discontinuation were included in the analysis. Missing data were imputed using unconditional reference based multiple imputation including data obtained after premature treatment discontinuation.||-1.19|-2.64|
72522584|NCT02773368|144574852|SUPERIORITY|Superiority of IDegLira was considered confirmed if the test procedure was not stopped (i.e. non-inferiority of IDegLira was confirmed for change from baseline in HbA1c and superiority of IDegLira was confirmed for change from baseline in body weight) and if the upper limit of the two-sided 95% CI for the rate ratio (IDegLira over IGlar) of rate of treatment-emergent severe or BG confirmed symptomatic hypoglycaemic episodes was strictly below 1.|Treatment Ratio|0.42|||||TWO_SIDED|95.0|0.23|0.75|||Negative binomial regression model||IDegLira over IGlar|This endpoint was analysed using a negative binomial regression model with a log link and the logarithm of the exposure time as offset. The model included treatment and pre-trial OAD as fixed factors. Missing data were imputed using multiple imputations (conditioning on expected event rate before premature treatment discontinuation or withdrawal from trial as if treated with IGlar).||0.75|0.23|
72522585|NCT02773368|144574853|SUPERIORITY|Superiority of IDegLira was considered confirmed if the test procedure was not stopped (i.e. non-inferiority of IDegLira was confirmed for change from baseline in HbA1c; and superiority of IDegLira was confirmed for weight change, number of treatment-emergent severe or BG confirmed symptomatic hypoglycaemic episodes and change in HbA1c) and if the upper limit of the two-sided 95% CI for the mean treatment difference (IDegLira minus IGlar) in insulin dose after 26 weeks was strictly below 0 U.|Treatment Contrast|-15.37|||||TWO_SIDED|95.0|-19.6|-11.13|||ANCOVA||IDegLira minus IGlar|The endpoint was analysed using an ANCOVA model with treatment, pre-trial OAD and region as factors and corresponding baseline HbA1c as covariate. Missing data were imputed using unconditional reference based multiple imputation including data obtained after premature treatment discontinuation.||-11.13|-19.60|
72522586|NCT01929018|144574883|SUPERIORITY|||||||0.87|||||||Mixed Models Analysis|||Test null hypothesis that there is no difference between groups from baseline to 12-week test.||||0.87
72522587|NCT01929018|144574883|SUPERIORITY|||||||0.38|||||||Mixed Models Analysis|||Test null hypothesis that there is no difference between groups from baseline to 24-week test.||||0.38
72522588|NCT01929018|144574884|SUPERIORITY|||||||0.75|||||||Mixed Models Analysis|||Test null hypothesis that there is no difference between groups from baseline to 12-week test.||||0.75
72570370|NCT02504671|144670136|OTHER||Difference|0.0|||||TWO_SIDED|95.0|-7.4|7.4|||||Index based ACR/EULAR, Week 8. Difference to Placebo for Week 8 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.4|-7.4|
72570371|NCT02504671|144670136|OTHER||Difference|0.0|||||TWO_SIDED|95.0|-7.4|7.4|||||Index based ACR/EULAR, Week 8. Difference to Placebo for Week 8 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.4|-7.4|
72570372|NCT02504671|144670136|OTHER||Difference|0.0|||||TWO_SIDED|95.0|-7.4|7.4|||||Index based ACR/EULAR, Week 12. Difference to Placebo for Week 12 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.4|-7.4|
72522589|NCT01929018|144574884|SUPERIORITY|||||||0.11|||||||Mixed Models Analysis|||Test null hypothesis that there is no difference between groups from baseline to 24-week test.||||0.11
72522590|NCT01929018|144574885|SUPERIORITY|||||||0.11|||||||Mixed Models Analysis|||Test null hypothesis that there is no difference between groups from baseline to 12-week test.||||0.11
72522591|NCT01929018|144574885|SUPERIORITY|||||||0.23|||||||Mixed Models Analysis|||Test null hypothesis that there is no difference between groups from baseline to 24-week test.||||0.23
72522592|NCT01929018|144574886|SUPERIORITY|||||||0.27|||||||Mixed Models Analysis|||Test null hypothesis that there is no difference between groups from baseline to 12-week test.||||0.27
72522593|NCT01929018|144574886|SUPERIORITY|||||||0.58|||||||Mixed Models Analysis|||Test null hypothesis that there is no difference between groups from baseline to 24-week test.||||0.58
72522594|NCT01929018|144574887|SUPERIORITY|||||||0.83|||||||Mixed Models Analysis|||Test null hypothesis that there is no difference between groups from baseline to 12-week test.||||0.83
72522595|NCT01929018|144574887|SUPERIORITY|||||||0.13|||||||Mixed Models Analysis|||Test null hypothesis that there is no difference between groups from baseline to 24-week test.||||0.13
72522596|NCT01929018|144574888|SUPERIORITY|||||||0.03|||||||t-test, 2 sided|||Test null hypothesis that there is no difference between groups from baseline to 12-week test.||||0.03
72522597|NCT01929018|144574888|SUPERIORITY|||||||0.02|||||||t-test, 2 sided|||Test null hypothesis that there is no difference between groups from baseline to 24-week test.||||0.02
72522598|NCT01929018|144574889|SUPERIORITY|||||||0.03|||||||Mixed Models Analysis|||Test null hypothesis that there is no difference between groups from baseline to 12-week test.||||0.03
72522599|NCT01929018|144574889|SUPERIORITY|||||||0.06|||||||Mixed Models Analysis|||Test null hypothesis that there is no difference between groups from baseline to 24-week test.||||0.06
72522600|NCT01929018|144574890|SUPERIORITY|||||||0.62|||||||Mixed Models Analysis|||Test null hypothesis that there is no difference between groups from baseline to 12-week test.||||0.62
72522601|NCT01929018|144574890|SUPERIORITY|||||||0.4|||||||Mixed Models Analysis|||Test null hypothesis that there is no difference between groups from baseline to 24-week test.||||0.40
72522602|NCT01929018|144574891|SUPERIORITY|||||||0.96|||||||Mixed Models Analysis|||Test null hypothesis that there is no difference between groups from baseline to 12-week test.||||0.96
72522603|NCT01929018|144574891|SUPERIORITY|||||||0.35|||||||Mixed Models Analysis|||Test null hypothesis that there is no difference between groups from baseline to 24-week test.||||0.35
72522604|NCT01789255|144574900|OTHER|||||||0.02642|||||||Wilcoxon (Mann-Whitney)|||||||0.02642
72522605|NCT01789255|144574901|OTHER|||||||0.028|||||||Wilcoxon (Mann-Whitney)|||||||0.028
72522606|NCT02635867|144574902|SUPERIORITY|Descriptive data and rates of success were calculated independently for indirect and direct therapies. Statistical analyses of proportions were done using Fisher's test and 95% confidence intervals (CI)|||||>|0.1|||||||Fisher Exact|||"The clinical outcome measures assessed were pain using visual analog pain scale, pulp vitality assessment at 12 months.~The success rate was based on 3 measures of pulp vitality that resulted in a diagnosis of vital or nonvital:~Vital: palpation = negative/ percussion = negative/ response to cold stimuli= positive response Non vital: palpation = positive / percussion = positive. / response to cold stimuli= positive or delayed response time in seconds and lingering."||||>0.1
72522607|NCT01704976|144574929|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||< 0.05
72522608|NCT01704976|144574930|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||< 0.05
72522609|NCT01704976|144574931|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||< 0.05
72522610|NCT01704976|144574932|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||< 0.05
72522611|NCT01704976|144574933|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||< 0.05
72522612|NCT00329784|144574934|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Chi-squared|||||||<0.0001
72522613|NCT00329784|144574934|SUPERIORITY_OR_OTHER|||||||0.004|||||||Chi-squared|||||||0.004
72522614|NCT00329784|144574935|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Chi-squared|||||||<0.0001
72522615|NCT00329784|144574936|SUPERIORITY_OR_OTHER|||||||0.369|||||||Wilcoxon (Mann-Whitney)|||||||0.369
72522616|NCT00329784|144574937|SUPERIORITY_OR_OTHER|||||||0.642|||||||Chi-squared|||||||0.642
72522617|NCT00329784|144574938|SUPERIORITY_OR_OTHER|||||||0.417|||||||Chi-squared|||Comparison for Seasonal Rhinoconjunctivitis||||0.417
72522618|NCT00329784|144574938|SUPERIORITY_OR_OTHER|||||||0.926|||||||Chi-squared|||Comparison for Perennial Rhinoconjunctivitis||||0.926
72522619|NCT00329784|144574939|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Chi-squared|||Comparison for Peanut Wheal||||<0.001
72522620|NCT00329784|144574939|SUPERIORITY_OR_OTHER|||||||0.361|||||||Chi-squared|||Comparison for Egg Wheal||||0.361
72522621|NCT00329784|144574939|SUPERIORITY_OR_OTHER|||||||0.76|||||||Chi-squared|||Comparison for Milk Wheal||||0.760
72522622|NCT00329784|144574939|SUPERIORITY_OR_OTHER|||||||0.834|||||||Chi-squared|||Comparison for Sesame Wheal||||0.834
72522623|NCT00329784|144574939|SUPERIORITY_OR_OTHER|||||||0.882|||||||Chi-squared|||Comparison for Brazil Nut Wheal||||0.882
72522624|NCT00329784|144574939|SUPERIORITY_OR_OTHER|||||||0.226|||||||Chi-squared|||Comparison for Hazel Nut Wheal||||0.226
72522625|NCT00329784|144574939|SUPERIORITY_OR_OTHER|||||||0.024|||||||Chi-squared|||Comparison for Cashew Wheal||||0.024
72522626|NCT00329784|144574939|SUPERIORITY_OR_OTHER|||||||0.204|||||||Chi-squared|||Comparison for Walnut Wheal||||0.204
72522627|NCT00329784|144574939|SUPERIORITY_OR_OTHER|||||||0.194|||||||Chi-squared|||Comparison for Almond Wheal||||0.194
72570373|NCT02504671|144670136|OTHER||Difference|0.0|||||TWO_SIDED|95.0|-7.4|7.4|||||Index based ACR/EULAR, Week 12. Difference to Placebo for Week 12 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.4|-7.4|
72522628|NCT00329784|144574940|SUPERIORITY_OR_OTHER|||||||0.859|||||||Chi-squared|||Comparison for Peanut IgE||||0.859
72570374|NCT02504671|144670136|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||Index based ACR/EULAR, Week 16. Difference to Placebo for Week 16 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
72570375|NCT02504671|144670136|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||Index based ACR/EULAR, Week 16. Difference to Placebo for Week 16 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
72570376|NCT02504671|144670136|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|12.7|||||Index based ACR/EULAR, Week 20. Difference to Placebo for Week 20 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-2.5|
72522629|NCT00329784|144574940|SUPERIORITY_OR_OTHER|||||||0.885|||||||Chi-squared|||Comparison for Egg IgE||||0.885
72522630|NCT00329784|144574940|SUPERIORITY_OR_OTHER|||||||0.403|||||||Chi-squared|||Comparison for Milk IgE||||0.403
72522631|NCT00329784|144574940|SUPERIORITY_OR_OTHER|||||||0.106|||||||Chi-squared|||Comparison for Sesame IgE||||0.106
72522632|NCT00329784|144574940|SUPERIORITY_OR_OTHER|||||||0.202|||||||Chi-squared|||Comparison for Brazil Nut IgE||||0.202
72522633|NCT00329784|144574940|SUPERIORITY_OR_OTHER|||||||0.108|||||||Chi-squared|||Comparison for Hazel Nut IgE||||0.108
72522634|NCT00329784|144574940|SUPERIORITY_OR_OTHER|||||||0.157|||||||Chi-squared|||Comparison for Cashew IgE||||0.157
72522635|NCT00329784|144574940|SUPERIORITY_OR_OTHER|||||||0.04|||||||Chi-squared|||Comparison for Walnut IgE||||0.040
72522636|NCT00329784|144574940|SUPERIORITY_OR_OTHER|||||||0.262|||||||Chi-squared|||Comparison for Almond IgE||||0.262
72522637|NCT00838383|144574943|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-70.0||||0.5307|TWO_SIDED|95.0|-291.3|151.4|||ANCOVA|||||151.4|-291.3|0.5307
72522638|NCT00838383|144574943|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-73.2||||0.5121|TWO_SIDED|95.0|-294.5|148.2|||ANCOVA|||||148.2|-294.5|0.5121
72522639|NCT00838383|144574944|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-123.1||||0.2735|TWO_SIDED|95.0|-345.5|99.3|||ANCOVA|||||99.3|-345.5|0.2735
72522640|NCT00838383|144574944|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-174.5||||0.1223|TWO_SIDED|95.0|-396.8|47.9|||ANCOVA|||||47.9|-396.8|0.1223
72522641|NCT00838383|144574945|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-66.6||||0.5505|TWO_SIDED|95.0|-288.0|154.8|||ANCOVA|||||154.8|-288.0|0.5505
72522642|NCT00838383|144574945|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-110.3||||0.3237|TWO_SIDED|95.0|-331.7|111.0|||ANCOVA|||||111.0|-331.7|0.3237
72522643|NCT00838383|144574946|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-166.5||||0.1412|TWO_SIDED|95.0|-389.6|56.6|||ANCOVA|||||56.6|-389.6|0.1412
72522644|NCT00838383|144574946|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-199.8||||0.0813|TWO_SIDED|95.0|-425.0|25.5|||ANCOVA|||||25.5|-425.0|0.0813
72522645|NCT01449955|144574985|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||ANOVA|||ANOVA comparing the results of change over time (e.g., comparing baseline to 1 month posttreatment) as well as comparing differences between condition (e.g., placebo compared to rapamycin).||||>0.05
72522646|NCT01449955|144574986|SUPERIORITY||||||>|0.5|||||||ANOVA|||||||> 0.5
72522647|NCT01449955|144574987|SUPERIORITY||||||>|0.05|||||||ANOVA|||||||> .05
72522648|NCT01449955|144574988|SUPERIORITY||||||>|0.05|||||||ANOVA|||||||> .05
72522649|NCT01449955|144574989|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||< .05
72522650|NCT01449955|144574990|SUPERIORITY||||||>|0.05|||||||ANOVA|||||||> .05
72522651|NCT00431496|144574991|SUPERIORITY_OR_OTHER||Percentage of participants|42.3||||||95.0|30.8|53.7||||||||53.7|30.8|
72522652|NCT00431496|144574992|SUPERIORITY_OR_OTHER||Percentage of participants|52.1||||||95.0|40.5|63.7||||||||63.7|40.5|
72522653|NCT00431496|144574993|SUPERIORITY_OR_OTHER||Percentage of participants|78.9||||||95.0|69.4|88.4||||||||88.4|69.4|
72522654|NCT00431496|144574994|SUPERIORITY_OR_OTHER||Percentage of participants|54.9||||||95.0|43.4|66.5||||||||66.5|43.4|
72522655|NCT00431496|144574995|SUPERIORITY_OR_OTHER||Percentage of participants|53.5||||||95.0|41.9|65.1||||||||65.1|41.9|
72522656|NCT00431496|144574996|SUPERIORITY_OR_OTHER||Percentage of participants|46.5||||||95.0|34.9|58.1||||||||58.1|34.9|
72522657|NCT02566109|144574997|OTHER|Estimation of Pearson correlation|Pearson Correlation Coefficient|-0.57472||||0.6102|TWO_SIDED||||||Pearson Correlation Coefficient|||Correlation between baseline and 2 months.||||0.6102
72522658|NCT02566109|144574997|OTHER|Correlation|Pearson Correlation Coefficient|0.25733||||0.8343|TWO_SIDED||||||Peason Correlation Coefficient|||Correlation between baseline and 6 months.||||0.8343
72522659|NCT02566109|144574998|OTHER|Pearson Correlation Coefficient|Pearson Correlation Coefficient|-0.09487||||0.9395|TWO_SIDED||||||Pearson Correlation Coefficient|||Correlation between baseline and 2 months.||||0.9395
72522660|NCT02566109|144574998|OTHER|Pearson Correlation Coefficient|Pearson Correlation Coefficient|0.97287||||0.1486|TWO_SIDED||||||Pearson Correlation Coefficient|||Correlation between baseline and 6 months.||||0.1486
72522661|NCT02566109|144574999|OTHER|Pearson Correlation Coefficient|Pearson Correlation Coefficient|0.10327||||0.9341|TWO_SIDED||||||Pearson Correlation Coefficient|||Correlation between baseline and 2 months.||||0.9341
72522662|NCT02566109|144574999|OTHER|Pearson Correlation Coefficient|Pearson Correlation Coefficient|0.99696||||0.0497|TWO_SIDED||||||Pearson Correlation Coefficient|||Correlation between baseline and 6 months.||||0.0497
72522663|NCT02566109|144575000|OTHER|Pearson Correlation Coefficient|Pearson Correlation Coefficient|0.98432||||0.1129|TWO_SIDED||||||Pearson Correlation Coefficient|||||||0.1129
72522664|NCT01906476|144575005|NON_INFERIORITY|Non-inferiority trials of pharmaceuticals have used 30% to 50% of the difference between treatment and control conditions to define non-inferiority margins. (Jones, Jarvis, Lewis, \& Ebbutt, 1996; Nutt et al., 2008). A meta-analysis of CBT found an overall effect size of d=0.82.(Cuijpers, Smit, Bohlmeijer, Hollon, \& Andersson, 2010). Using the midpoint of 40% for the acceptable criterion, we set d=0.33 as the non-inferiority criterion.|||||||||||||||||"Cohen's d and upper limits of one-sided 95% Confidence intervals for each time are as follows:~Mid-treatment -0.19 (95% upper limit= 0.06) End of treatment 0.03 (0.24) 3 months post treatment -0.02 (0.19) 6 months post treatment -0.07 (0.14)"|||
72570377|NCT02504671|144670136|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|68.2|||||Index based ACR/EULAR, Week 20. Difference to Placebo for Week 20 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||68.2|-1.9|
72406159|NCT04108208|144320893|SUPERIORITY||Hazard Ratio (HR)|0.233|||=|0.0052|TWO_SIDED|95.0|0.077|0.705|||Log Rank|||||0.705|0.077|=0.0052
72406160|NCT00409292|144320927|SUPERIORITY_OR_OTHER|||||||0.1|||||||binomial hypothesis test|||||||0.10
72406161|NCT00376168|144320932|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||one-sample t-test|one-sample t-test (combined) to test the null hypothesis that percent change = 0||"The primary efficacy analysis was based on two one-sample t-tests (one for each treatment group) to determine if the percent change in spleen volume is different than zero.~With 12 patients in each treatment group, there was greater than 95% power to detect a change of 20% or more using a one-sample t-test (alpha=0.025, 2-sided test to allow for each group to be tested separately) to evaluate the primary outcome of percent change in spleen volume after nine months."||||<0.0001
72406162|NCT00376168|144320932|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||threshold for statistical significance = 0.025|one-sample t-test|one-sample t-test (combined) to test the null hypothesis that percent change = 0||"The primary efficacy analysis was based on two one-sample t-tests (one for each treatment group) to determine if the percent change in spleen volume is different than zero.~With 12 patients in each treatment group, there was greater than 95% power to detect a change of 20% or more using a one-sample t-test (alpha=0.025, 2-sided test to allow for each group to be tested separately) to evaluate the primary outcome of percent change in spleen volume after nine months."||||<0.0001
72406163|NCT00376168|144320933|SUPERIORITY_OR_OTHER|||||||0.0041||95.0|||||One-sample t-test|||For each of the secondary endpoints, a one-sample t-test (% change in liver volume, mean change in hemoglobin and platelet count) was examined first for each dose using the step-down approach. Next, a mixed effects model that included dose and time, with subject as a random effect, was fit to examine whether there was a difference between dose groups, for those outcomes that were tested in the step-down approach.||||0.0041
72406164|NCT00376168|144320933|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||One-sample t-test|||For each of the secondary endpoints, a one-sample t-test (% change in liver volume, mean change in hemoglobin and platelet count) was examined first for each dose using the step-down approach. Next, a mixed effects model that included dose and time, with subject as a random effect, was fit to examine whether there was a difference between dose groups, for those outcomes that were tested in the step-down approach.||||<0.0001
72522665|NCT01906476|144575006|SUPERIORITY||ICER estimate|-152.55|||||TWO_SIDED|95.0|-1143.09|1094.72||||||We calculated the ICER (Incremental cost-effectiveness ratio) estimate, computed using the difference in average cost between the two arms, divided by the difference in average Depression Free Days (DFD) as defined using QIDS (Quick Inventory of Depressive Symptomatology), between the two arms, Stepped Care minus Telephone Cognitive Behavior Therapy. The confidence interval was created using bootstrapping.||1094.72|-1143.09|
72522666|NCT02896192|144575010|OTHER||CI||||<|0.0001||||||One-sided p-value obtained from exact binomial test, testing that at least 5% of participants in the population of interest would achieve 10% weight loss.|Exact binomial test|||||||<0.0001
72522667|NCT02896192|144575011|OTHER||||||<|0.0001||||||One-sided p-value obtained from exact binomial test, testing that at least 5% of participants in the population of interest would achieve 10% weight loss.|Exact binomial test|||||||<0.0001
72522668|NCT02896192|144575012|OTHER||Least Squares Mean|-25.73|||<|0.0001|TWO_SIDED|90.0|-28.49|-22.98|||Longitudinal mixed analysis of variance|||Model based summary statistics from longitudinal mixed analysis of variance model with fixed effect for visit, baseline body weight and random effect for participant, one sided p-value from model.||-22.98|-28.49|<0.0001
72522669|NCT02896192|144575013|OTHER||Least Squares Mean|-27.77||||0.0005|TWO_SIDED|90.0|-40.58|-14.96|||Longitudinal mixed analysis of variance|||Model based summary statistics from longitudinal mixed analysis of variance model with fixed effect for week, baseline daily hunger score and random effect for participant, one sided p-value from model.||-14.96|-40.58|0.0005
72522670|NCT02896192|144575014|OTHER|||||||0.0004||||||One-sided p-value obtained from exact binomial test, testing that ≥ 5% of participants in the population of interest would achieve ≥ 25% improvement in daily hunger score.|Exact binomial test|||||||0.0004
72522671|NCT02896192|144575015|OTHER||Least Squares Mean|-18.1|||<|0.0001|TWO_SIDED|90.0|-21.27|-14.88|||Longitudinal mixed analysis of variance|||Model based summary statistics from longitudinal mixed analysis of variance model with fixed effect for visit, baseline waist circumference and random effect for participant, one sided p-value from model.||-14.88|-21.27|<0.0001
72406165|NCT00376168|144320934|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||One-sample t-test|||For each of the secondary endpoints, a one-sample t-test (% change in liver volume, mean change in hemoglobin and platelet count) was examined first for each dose using the step-down approach. Next, a mixed effects model that included dose and time, with subject as a random effect, was fit to examine whether there was a difference between dose groups, for those outcomes that were tested in the step-down approach.||||0.0010
72406166|NCT00376168|144320934|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||One-sample t-test|||For each of the secondary endpoints, a one-sample t-test (% change in liver volume, mean change in hemoglobin and platelet count) was examined first for each dose using the step-down approach. Next, a mixed effects model that included dose and time, with subject as a random effect, was fit to examine whether there was a difference between dose groups, for those outcomes that were tested in the step-down approach.||||<0.0001
72522672|NCT02896192|144575018|OTHER||Least Squares Mean|-27.4|||<|0.0001|TWO_SIDED|90.0|-30.6|-24.29|||Longitudinal mixed analysis of variance|||Model based summary statistics from longitudinal mixed analysis of variance model with fixed effect for week, baseline BMI and random effect for participant, one sided p-value from model.||-24.29|-30.60|<0.0001
72522673|NCT02448914|144575037|NON_INFERIORITY_OR_EQUIVALENCE|Analysis was first to attempt to show non-inferiority. To show non-inferiority of TRIGEL over Duodopa, the lower limit of the two-sided CI for the treatment ratio had to be above the chosen non-inferiority margin of 0.9. If non-inferiority was shown, analysis continued with test of superiority. To show superiority of TRIGEL versus Duodopa, the lower confidence limit had to be above 1 (corresponding to a p-value less than 0.05).|back-transformed ratio|1.382|||<|0.0001|TWO_SIDED|95.0|1.264|1.511|||ANCOVA|||Levodopa AUC 0-14h/dose, was derived using the trapezoidal method and divided by the total administered dose of levodopa during the corresponding time interval.The primary endpoint was log transformed and analysed using an ANCOVA, adjusting for treatment, period and patient. The back-transformed ratio of TRIGEL over Duodopa was calculated together with 95% confidence intervals (CI) and the associated (2 sided) p value.||1.511|1.264|<0.0001
72522674|NCT00560794|144575055|SUPERIORITY_OR_OTHER|||||||0|TWO_SIDED|||||The null hypothesis stated that the true MRD response probability (π) ≤ 5%.|1-sided exact binomial test|||||||0.0000
72406167|NCT00376168|144320935|SUPERIORITY_OR_OTHER|||||||0.046||95.0|||||One-sample t-test|||For each of the secondary endpoints, a one-sample t-test (% change in liver volume, mean change in hemoglobin and platelet count) was examined first for each dose using the step-down approach. Next, a mixed effects model that included dose and time, with subject as a random effect, was fit to examine whether there was a difference between dose groups, for those outcomes that were tested in the step-down approach.||||0.0460
72522675|NCT04857892|144575069|OTHER||Ratio of geometric Least Square mean|1.025|||||TWO_SIDED|90.0|0.9335|1.126|||||An analysis of variance with treatment, period, and sequence as fixed effects and participant nested within a sequence as a random effect was performed on the natural ln-transformed parameter AUC(0-inf).|||1.126|0.9335|
72522676|NCT04857892|144575069|OTHER||Ratio of geometric Least Square mean|1.072|||||TWO_SIDED|90.0|0.9693|1.185|||||An analysis of variance with treatment, period, and sequence as fixed effects and participant nested within a sequence as a random effect was performed on the natural ln-transformed parameter AUC(0-inf).|||1.185|0.9693|
72522677|NCT04857892|144575070|OTHER||Ratio of geometric Least Square mean|1.126|||||TWO_SIDED|90.0|0.9918|1.278|||||An analysis of variance with treatment, period, and sequence as fixed effects and participant nested within a sequence as a random effect was performed on the natural ln-transformed parameter AUC(0-t).|||1.278|0.9918|
72522678|NCT04857892|144575070|OTHER||Ratio of geometric Least Square mean|1.055|||||TWO_SIDED|90.0|0.9278|1.201|||||An analysis of variance with treatment, period, and sequence as fixed effects and participant nested within a sequence as a random effect was performed on the natural ln-transformed parameter AUC(0-t).|||1.201|0.9278|
72522679|NCT04857892|144575071|OTHER||Ratio of geometric Least Square mean|1.036|||||TWO_SIDED|90.0|0.9209|1.166|||||An analysis of variance with treatment, period, and sequence as fixed effects and participant nested within a sequence as a random effect was performed on the natural ln-transformed parameter Cmax.|||1.166|0.9209|
72522680|NCT04857892|144575071|OTHER||Ratio of geometric Least Square mean|1.02|||||TWO_SIDED|90.0|0.9049|1.151|||||An analysis of variance with treatment, period, and sequence as fixed effects and participant nested within a sequence as a random effect was performed on the natural ln-transformed parameter Cmax.|||1.151|0.9049|
72522681|NCT04857892|144575072|OTHER||Ratio of geometric Least Square mean|1.129|||||TWO_SIDED|90.0|1.067|1.195|||||An analysis of variance with treatment, period, and sequence as fixed effects and participant nested within a sequence as a random effect was performed on the natural ln-transformed parameter AUC(0-inf).|||1.195|1.067|
72522682|NCT04857892|144575072|OTHER||Ratio of geometric Least Square mean|1.112|||||TWO_SIDED|90.0|1.05|1.178|||||An analysis of variance with treatment, period, and sequence as fixed effects and participant nested within a sequence as a random effect was performed on the natural ln-transformed parameter AUC(0-inf).|||1.178|1.050|
72522683|NCT04857892|144575073|OTHER||Ratio of geometric Least Square mean|1.164|||||TWO_SIDED|90.0|1.07|1.267|||||An analysis of variance with treatment, period, and sequence as fixed effects and participant nested within a sequence as a random effect was performed on the natural ln-transformed parameter AUC(0-t).|||1.267|1.070|
72522684|NCT04857892|144575073|OTHER||Ratio of geometric Least Square mean|1.087|||||TWO_SIDED|90.0|0.9975|1.184|||||An analysis of variance with treatment, period, and sequence as fixed effects and participant nested within a sequence as a random effect was performed on the natural ln-transformed parameter AUC(0-t).|||1.184|0.9975|
72522685|NCT04857892|144575074|OTHER||Ratio of geometric Least Square mean|1.078|||||TWO_SIDED|90.0|1.036|1.122|||||An analysis of variance with treatment, period, and sequence as fixed effects and participant nested within a sequence as a random effect was performed on the natural ln-transformed parameter Cmax|||1.122|1.036|
72522686|NCT04857892|144575074|OTHER||Ratio of geometric Least Square mean|1.032|||||TWO_SIDED|90.0|0.9914|1.075|||||An analysis of variance with treatment, period, and sequence as fixed effects and participant nested within a sequence as a random effect was performed on the natural ln-transformed parameter Cmax|||1.075|0.9914|
72570378|NCT02504671|144670136|OTHER||Difference|8.1|||||TWO_SIDED|95.0|-0.7|16.9|||||Index based ACR/EULAR, Week 24. Difference to Placebo for Week 24 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||16.9|-0.7|
72406168|NCT00376168|144320935|SUPERIORITY_OR_OTHER|||||||0.0031||95.0|||||One-sample t-test|||For each of the secondary endpoints, a one-sample t-test (% change in liver volume, mean change in hemoglobin and platelet count) was examined first for each dose using the step-down approach. Next, a mixed effects model that included dose and time, with subject as a random effect, was fit to examine whether there was a difference between dose groups, for those outcomes that were tested in the step-down approach.||||0.0031
72522687|NCT04857892|144575075|OTHER||Ratio of geometric Least Square mean|2.705|||||TWO_SIDED|90.0|2.135|3.427|||||An analysis of variance with treatment, period, and sequence as fixed effects and participant nested within a sequence as a random effect was performed on the natural ln-transformed parameter AUC(0-inf)|||3.427|2.135|
72522688|NCT04857892|144575076|OTHER||Ratio of geometric Least Square mean|2.761|||||TWO_SIDED|90.0|2.16|3.527|||||An analysis of variance with treatment, period, and sequence as fixed effects and participant nested within a sequence as a random effect was performed on the natural ln-transformed parameter AUC(0-t)|||3.527|2.160|
72522689|NCT04857892|144575077|OTHER||Ratio of geometric Least Square mean|2.498|||||TWO_SIDED|90.0|1.821|3.425|||||An analysis of variance with treatment, period, and sequence as fixed effects and participant nested within a sequence as a random effect was performed on the natural ln-transformed parameter Cmax|||3.425|1.821|
72522690|NCT04857892|144575078|OTHER||Ratio of geometric Least Square mean|1.316|||||TWO_SIDED|90.0|1.193|1.451|||||An analysis of variance with treatment, period, and sequence as fixed effects and participant nested within a sequence as a random effect was performed on the natural ln-transformed parameter AUC(0-inf)|||1.451|1.193|
72522691|NCT04857892|144575079|OTHER||Ratio of geometric Least Square mean|1.316|||||TWO_SIDED|90.0|1.193|1.452|||||An analysis of variance with treatment, period, and sequence as fixed effects and participant nested within a sequence as a random effect was performed on the natural ln-transformed parameter AUC(0-t)|||1.452|1.193|
72522692|NCT04857892|144575080|OTHER||Ratio of geometric Least Square mean|1.232|||||TWO_SIDED|90.0|1.138|1.333|||||An analysis of variance with treatment, period, and sequence as fixed effects and participant nested within a sequence as a random effect was performed on the natural ln-transformed parameter Cmax|||1.333|1.138|
72522693|NCT00655811|144575176|SUPERIORITY||||||<|0.05|||||||ANOVA|||One-way anova was used to compare the mean COVAS values between groups.||||<0.05
72406169|NCT02350309|144320937|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.15||||0.0262|ONE_SIDED|95.0|-2.12|||The mixed model included treatment, period and sequence as fixed effects, baseline (predose) measurement as a covariate, and participant nested within treatment sequence as a random effect.|Mixed Models Analysis||||||-2.12|0.0262
72406170|NCT02350309|144320937|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.48|||<|0.0001|ONE_SIDED|95.0|-4.46|||The mixed model included treatment, period and sequence as fixed effects, baseline (predose) measurement as a covariate, and participant nested within treatment sequence as a random effect.|Mixed Models Analysis||||||-4.46|<0.0001
72522694|NCT00655811|144575176|SUPERIORITY|||||||0.55|||||||t-test, 2 sided|||||||0.550
72522695|NCT00655811|144575176|SUPERIORITY|||||||0.005|||||||t-test, 2 sided|||||||0.005
72522696|NCT00655811|144575176|SUPERIORITY|||||||0.027|||||||t-test, 2 sided|||||||0.027
72522697|NCT00655811|144575177|SUPERIORITY|||||||0.012|||||||t-test, 2 sided|||||||0.012
72522698|NCT00655811|144575177|SUPERIORITY|||||||0.06|||||||t-test, 2 sided|||||||0.06
72522699|NCT00655811|144575177|SUPERIORITY|||||||0.002|||||||t-test, 2 sided|||||||0.002
72522700|NCT00655811|144575178|SUPERIORITY|||||||0.06|||||||t-test, 2 sided|||||||0.06
72522701|NCT00118404|144575207|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.079|STANDARD_ERROR_OF_MEAN|0.39||0.42|TWO_SIDED|95.0|0.5|2.34|||Log Rank|log-rank chi-square = 0.038, df = 1, p \<=.42|Hazard ratio for relapse in C-CT group compared to that in the fluoxetine group.|The sample size was based on a predicted 30% difference in relapse/recurrence rates between C-CT and fluoxetine (ie,30% vs 60%) across both the experimental phase and the first 12 months of follow-up. With these assumptions, 180 randomized patients (60 per cell) were required to detect a statistically significant difference using a log-rank test with 1-sided α = 0.05 and 80% power.||2.34|0.50|.42
72522702|NCT00118404|144575207|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.481|STANDARD_ERROR_OF_MEAN|0.38||0.02|TWO_SIDED|95.0|0.23|1.01|||Log Rank|log-rank chi-square = 3.92, df = 1|Hazard Ratio for relapse in fluoxetine group compared to that in the pill placebo group.|||1.01|.23|.02
72522703|NCT00118404|144575207|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.519|STANDARD_ERROR_OF_MEAN|0.36||0.03|TWO_SIDED|95.0|0.26|1.06|||Log Rank|log-rank chi-square = 3.391, df = 1|Hazard ratio for relapse in C-CT group compared to that in the placebo group.|||1.06|0.26|.03
72522704|NCT00118404|144575207|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.501|STANDARD_ERROR_OF_MEAN|0.31||0.01|TWO_SIDED|95.0|0.27|0.93|||Log Rank|log-rank chi-square = 5.06, df = 1|Hazard ratio for relapse in active treatment group (fluoxetine or C-CT) compared to that in the placebo group.|||0.93|0.27|.01
72522705|NCT00118404|144575208|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.988|STANDARD_ERROR_OF_MEAN|0.3||0.48|TWO_SIDED|95.0|0.55|1.76|||Log Rank|log-rank chi-square = 0.002, df = 1|Hazard ratio for relapse/recurrence in the C-CT group compared to that in the fluoxetine group.|||1.76|0.55|.48
72406171|NCT02350309|144320938|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0215||||||P-value was calculated based on non-missing two-way contingency table between placebo and study treatment.|McNemar|||||||0.0215
72406172|NCT02350309|144320938|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||P-value was calculated based on non-missing two-way contingency table between placebo and study treatment.|McNemar|||||||<0.0001
72406173|NCT02350309|144320938|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||P-value was calculated based on non-missing two-way contingency table between placebo and study treatment.|McNemar|||||||<0.0001
72522706|NCT00118404|144575208|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.717|STANDARD_ERROR_OF_MEAN|0.31||0.14|TWO_SIDED|95.0|0.39|1.31|||Log Rank|Chi-square = 1.19, df = 1|Hazard ratio of relapse/recurrence in the Fluoxetine arm over the 20 months of follow-up since randomization compared to the pill placebo arm.|||1.31|.39|.14
72522707|NCT00118404|144575208|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.715|STANDARD_ERROR_OF_MEAN|0.3||0.13|TWO_SIDED|95.0|0.4|1.29|||Log Rank|chi-square = 1.262, df = 1|Hazard ratio of relapse/recurrence in the C-CT arm over the 20 months of follow-up since randomization compared to the pill placebo arm.|||1.29|.40|.13
72522708|NCT00118404|144575208|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.717|STANDARD_ERROR_OF_MEAN|0.26||0.1|TWO_SIDED|95.0|0.43|1.2|||Log Rank|Chi-square = 1.595, df = 1|Hazard of relapse/recurrence in the active treatment (FLX or C-CT) arm compared to PBO (placebo)arm.|||1.20|.43|.10
72522709|NCT00118404|144575209|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.075|STANDARD_ERROR_OF_MEAN|0.27||0.4|TWO_SIDED|95.0|0.63|1.84|||Log Rank|chi-square = .07, df = 1|Hazard of relapse/recurrence for C-CT arm compared to FLX arm was reported.|||1.84|.63|.40
72522710|NCT00118404|144575209|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.649|STANDARD_ERROR_OF_MEAN|0.28||0.61|TWO_SIDED|95.0|0.37|1.13|||Log Rank|chi-square = 2.407, df = 1|Hazard of relapse/recurrence in the FLX arm compared tp C-CT arm was reported.|||1.13|.37|.61
72522711|NCT00118404|144575209|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.701|STANDARD_ERROR_OF_MEAN|0.27||0.09|TWO_SIDED|95.0|0.41|1.19|||Log Rank|chi-square = 1.731, df = 1|Hazard of relapse/recurrence in the C-CT arm compared to PBO arm is reported.|||1.19|.41|.09
72522712|NCT00118404|144575209|SUPERIORITY_OR_OTHER||Hazard Ratio, log|0.676|STANDARD_ERROR_OF_MEAN|0.24||0.05|TWO_SIDED|95.0|0.42|1.08|||Log Rank|chi-square = 2.705, df = 1|Hazard of relapse/recurrence in the active treatment (FLX or C-CT) arm compared to PBO arm was reported.|||1.08|.42|.05
72570379|NCT02504671|144670136|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||Index based ACR/EULAR, Week 24. Difference to Placebo for Week 24 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
72522713|NCT00922974|144575225|SUPERIORITY|||||||0.99|||||||Fisher Exact|||Based on the one-sided exact binomial test with α=0.025 and a 2:1 randomization, 228 patients would be required to detect a 40% improvement in the response rate from 51% (external beam radiation therapy) to 70% (Radiosurgery/SBRT) with a statistical power of 0.80.||||0.99
72522714|NCT00922974|144575226|SUPERIORITY||Hazard Ratio (HR)|0.96||||0.38|TWO_SIDED|95.0|0.72|1.27|||Stratified log rank|One-sided significance level = 0.025.|Reference level = Radiosurgery/SBRT|||1.27|0.72|0.38
72522715|NCT00922974|144575227|SUPERIORITY||Hazard Ratio (HR)|1.73||||0.29|TWO_SIDED|95.0|0.24|12.8|||Stratified log rank|One-sided significance level = 0.025|Significance level = Radiosurgery/SBRT|||12.8|0.24|0.29
72522716|NCT00922974|144575228|SUPERIORITY|||||||0.93||||||Two-sided significance level = 0.05|Chi-squared|||Percentage of patients with treatment-related adverse events.||||0.93
72522717|NCT00922974|144575228|SUPERIORITY|||||||0.09||||||Two-sided significance level = 0.05|Chi-squared|||Percentage of patients with any adverse events.||||0.09
72522718|NCT00922974|144575229|SUPERIORITY|||||||0.59||||||Two-sided significance level = 0.05|Gray's test|||||||0.59
72522719|NCT00922974|144575230|SUPERIORITY|||||||0.38||||||Two-sided significance level = 0.05|Gray's test|||||||0.38
72522720|NCT00922974|144575231|SUPERIORITY|||||||0.28|||||||t-test, 2 sided|||Assuming that the data are normally distributed, the two sample t-test assuming equal variances will be used to test the hypothesis at the one-sided 0.025 significance level. A mean difference of 7 points represents a clinically meaningful change (CMC). A difference of less than 7 points between the treatment arms will not be considered meaningful, even if it has statistical significance.||||0.28
72522721|NCT00922974|144575232|SUPERIORITY|||||||0.4313|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A general linear mixed-effect model was run with BPI Worst Pain Score (baseline, 3, 6, 12, and 24 months) as the outcome of interest. Age, gender, race, Zubrod performance status, pain medication, tumor type, time, and treatment arm were the covariates considered in each model. Treatment Arm (External Beam Radiation Therapy vs. Radiosurgery/SBRT) is reported here.||||0.4313
72522722|NCT00922974|144575232|SUPERIORITY|||||||0.8707|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A general linear mixed-effect model was run with BPI Worst Pain Score (baseline, 3, 6, 12, and 24 months) as the outcome of interest. Age, gender, race, Zubrod performance status, pain medication, tumor type, time, and treatment arm were the covariates considered in each model. Age (\< 63 years vs. ≥ 63 years) is reported here.||||0.8707
72522723|NCT00922974|144575232|SUPERIORITY|||||||0.1549|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A general linear mixed-effect model was run with BPI Worst Pain Score (baseline, 3, 6, 12, and 24 months) as the outcome of interest. Age, gender, race, Zubrod performance status, pain medication, tumor type, time, and treatment arm were the covariates considered in each model. Gender (female vs. male) is reported here.||||0.1549
72522724|NCT00922974|144575232|SUPERIORITY|||||||0.0193|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A general linear mixed-effect model was run with BPI Worst Pain Score (baseline, 3, 6, 12, and 24 months) as the outcome of interest. Age, gender, race, Zubrod performance status, pain medication, tumor type, time, and treatment arm were the covariates considered in each model. Race (Other vs. while) is reported here.||||0.0193
72522725|NCT00922974|144575232|SUPERIORITY|||||||0.0016|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A general linear mixed-effect model was run with BPI Worst Pain Score (baseline, 3, 6, 12, and 24 months) as the outcome of interest. Age, gender, race, Zubrod performance status, pain medication, tumor type, time, and treatment arm were the covariates considered in each model. Zubrod performance status (0 vs. 1,2) is reported here.||||0.0016
72522726|NCT00922974|144575232|SUPERIORITY|||||||0.0003|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A general linear mixed-effect model was run with BPI Worst Pain Score (baseline, 3, 6, 12, and 24 months) as the outcome of interest. Age, gender, race, Zubrod performance status, pain medication, tumor type, time, and treatment arm were the covariates considered in each model. Taking pain medication (No vs. Yes) is reported here.||||0.0003
72522727|NCT00922974|144575232|SUPERIORITY|||||||0.6371|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A general linear mixed-effect model was run with BPI Worst Pain Score (baseline, 3, 6, 12, and 24 months) as the outcome of interest. Age, gender, race, Zubrod performance status, pain medication, tumor type, time, and treatment arm were the covariates considered in each model. Tumor type (radioresistant vs. other) is reported here.||||0.6371
72522728|NCT00922974|144575233|SUPERIORITY|||||||0.0218|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A general linear mixed-effect model was run with EQ-5D Index Score (baseline, 3, 6, 12, and 24 months) as the outcome of interest. Age, gender, race, Zubrod performance status, pain medication, tumor type, time, and treatment arm were the covariates considered in each model. Treatment Arm (External Beam Radiation Therapy vs. Radiosurgery/SBRT) is reported here.||||0.0218
72522729|NCT00922974|144575233|SUPERIORITY|||||||0.9437|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A general linear mixed-effect model was run with EQ-5D Index Score (baseline, 3, 6, 12, and 24 months) as the outcome of interest. Age, gender, race, Zubrod performance status, pain medication, tumor type, time, and treatment arm were the covariates considered in each model. Age (\< 63 years vs. ≥ 63 years) is reported here.||||0.9437
72522730|NCT00922974|144575233|SUPERIORITY|||||||0.0696|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A general linear mixed-effect model was run with EQ-5D Index Score (baseline, 3, 6, 12, and 24 months) as the outcome of interest. Age, gender, race, Zubrod performance status, pain medication, tumor type, time, and treatment arm were the covariates considered in each model. Gender (female vs. male) is reported here.||||0.0696
72522731|NCT00922974|144575233|SUPERIORITY|||||||0.114|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A general linear mixed-effect model was run with EQ-5D Index Score (baseline, 3, 6, 12, and 24 months) as the outcome of interest. Age, gender, race, Zubrod performance status, pain medication, tumor type, time, and treatment arm were the covariates considered in each model. Race (Other vs. while) is reported here.||||0.1140
72522732|NCT00922974|144575233|SUPERIORITY|||||||0.0003|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A general linear mixed-effect model was run with EQ-5D Index Score (baseline, 3, 6, 12, and 24 months) as the outcome of interest. Age, gender, race, Zubrod performance status, pain medication, tumor type, time, and treatment arm were the covariates considered in each model. Zubrod performance status (0 vs. 1,2) is reported here.||||0.0003
72522733|NCT00922974|144575233|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A general linear mixed-effect model was run with EQ-5D Index Score (baseline, 3, 6, 12, and 24 months) as the outcome of interest. Age, gender, race, Zubrod performance status, pain medication, tumor type, time, and treatment arm were the covariates considered in each model. Taking pain medication (No vs. Yes) is reported here.||||<0.0001
72522734|NCT00922974|144575233|SUPERIORITY|||||||0.7732|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A general linear mixed-effect model was run with EQ-5D Index Score (baseline, 3, 6, 12, and 24 months) as the outcome of interest. Age, gender, race, Zubrod performance status, pain medication, tumor type, time, and treatment arm were the covariates considered in each model. Tumor type (radioresistant vs. other) is reported here.||||0.7732
72522735|NCT00922974|144575234|SUPERIORITY|||||||0.5198|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A general linear mixed-effect model was run with FACT-G total score (baseline, 3, 6, 12, and 24 months) as the outcome of interest. Age, gender, race, Zubrod performance status, pain medication, tumor type, time, and treatment arm were the covariates considered in each model. Treatment Arm (External Beam Radiation Therapy vs. Radiosurgery/SBRT) is reported here.||||0.5198
72522736|NCT00922974|144575234|SUPERIORITY|||||||0.1197|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A general linear mixed-effect model was run with FACT-G total score (baseline, 3, 6, 12, and 24 months) as the outcome of interest. Age, gender, race, Zubrod performance status, pain medication, tumor type, time, and treatment arm were the covariates considered in each model. Age (\< 63 years vs. ≥ 63 years) is reported here.||||0.1197
72522737|NCT00922974|144575234|SUPERIORITY|||||||0.0306|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A general linear mixed-effect model was run with FACT-G total score (baseline, 3, 6, 12, and 24 months) as the outcome of interest. Age, gender, race, Zubrod performance status, pain medication, tumor type, time, and treatment arm were the covariates considered in each model. Gender (female vs. male) is reported here.||||0.0306
72522738|NCT00922974|144575234|SUPERIORITY|||||||0.7903|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A general linear mixed-effect model was run with FACT-G total score (baseline, 3, 6, 12, and 24 months) as the outcome of interest. Age, gender, race, Zubrod performance status, pain medication, tumor type, time, and treatment arm were the covariates considered in each model. Race (Other vs. while) is reported here.||||0.7903
72522739|NCT00922974|144575234|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A general linear mixed-effect model was run with FACT-G total score (baseline, 3, 6, 12, and 24 months) as the outcome of interest. Age, gender, race, Zubrod performance status, pain medication, tumor type, time, and treatment arm were the covariates considered in each model. Zubrod performance status (0 vs. 1,2) is reported here.||||<0.0001
72522740|NCT00922974|144575234|SUPERIORITY|||||||0.0026|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A general linear mixed-effect model was run with FACT-G total score (baseline, 3, 6, 12, and 24 months) as the outcome of interest. Age, gender, race, Zubrod performance status, pain medication, tumor type, time, and treatment arm were the covariates considered in each model. Taking pain medication (No vs. Yes) is reported here.||||0.0026
72522741|NCT00922974|144575234|SUPERIORITY|||||||0.3282|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A general linear mixed-effect model was run with FACT-G total score (baseline, 3, 6, 12, and 24 months) as the outcome of interest. Age, gender, race, Zubrod performance status, pain medication, tumor type, time, and treatment arm were the covariates considered in each model. Tumor type (radioresistant vs. other) is reported here.||||0.3282
72522742|NCT03950440|144575235|OTHER|Propensity scores were obtained from three separate multivariable logistic regression models contrasting each group versus the two other groups. The result from this multivariable model quantifies the degree of separation between both groups.|Risk Ratio (RR)|0.26|||<|0.0001|TWO_SIDED|95.0|0.16|0.44||The double robust approach refers to the weighted analysis with all variables involved in the construction of the propensity-based weights added as confounders in the model.|Poisson regression||TAVI-group compared to the SAVR-group|Frailty scores (Tilburg and essential) and Euroscore were specified in the protocol. Age was added during the meeting before start of the data-analysis|The double robust approach refers to the weighted analysis with all variables involved in the construction of the propensity-based weights added as confounders in the model.|0.44|0.16|<0.0001
72522743|NCT01957215|144575246|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.72||||0.0201||95.0|0.1134|1.3199||P- value was obtained from ANCOVA model with treatment and site as fixed effects and NRS Baseline value as a covariate|ANCOVA||ADJ DIFF is the Treatment difference defined as the Adjusted Mean of 0.35% Indomethacin Patches minus Adjusted Mean of Placebo Patches|||1.3199|0.1134|0.0201
72570380|NCT02504671|144670136|OTHER||Difference|8.1|||||TWO_SIDED|95.0|-0.7|16.9|||||Index based ACR/EULAR, Week 28. Difference to Placebo for Week 28 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||16.9|-0.7|
72570381|NCT02504671|144670136|OTHER||Difference|13.5|||||TWO_SIDED|95.0|2.5|24.5|||||Index based ACR/EULAR, Week 28. Difference to Placebo for Week 28 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||24.5|2.5|
72522744|NCT03180294|144575275|SUPERIORITY|||||||0.46|||||||t-test, 1 sided|||Using a two sample t-test with a one-sided type I error of 0.05 (overall type I error of 0.1 after a Bonferroni correction) and an effect size of 0.45, 62 patients/arm were calculated to be needed to achieve 80% statistical power. Adjusting for 20% non-compliance resulted in a total sample size of 234 patients..||||0.46
72570382|NCT02504671|144670136|OTHER||Difference|8.1|||||TWO_SIDED|95.0|-0.7|16.9|||||Index based ACR/EULAR, Week 32. Difference to Placebo for Week 32 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||16.9|-0.7|
72522745|NCT03180294|144575275|SUPERIORITY|||||||0.54|||||||t-test, 1 sided|||Using a two sample t-test with a one-sided type I error of 0.05 (overall type I error of 0.1 after a Bonferroni correction) and an effect size of 0.45, 62 patients/arm were calculated to be needed to achieve 80% statistical power. Adjusting for 20% non-compliance resulted in a total sample size of 234 patients..||||0.54
72522746|NCT03180294|144575276|SUPERIORITY|||||||0.95||||||One-sided significance level 0.05|t-test, 1 sided|||Week 5||||0.95
72522747|NCT03180294|144575276|SUPERIORITY|||||||0.73||||||One-sided significance level 0.05|t-test, 1 sided|||Week 5||||0.73
72570383|NCT02504671|144670136|OTHER||Difference|10.8|||||TWO_SIDED|95.0|0.8|20.8|||||Index based ACR/EULAR, Week 32. Difference to Placebo for Week 32 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||20.8|0.8|
72406174|NCT02114879|144320997|SUPERIORITY|||||||0.007||||||The p-value refers to the time by group interaction. The a priori threshold for statistical significance in this planned primary test was p\<0.05.|Marginal Model|||This Primary analysis used a marginal model with time (baseline and discharge), condition (EMR vs SOC), and time x condition as fixed effects, with an unstructured covariance structure specified, based on Bayesian information criteria (BIC).||||0.007
72406175|NCT02114879|144320998|SUPERIORITY|||||||0.11|||||||Wilcoxon (Mann-Whitney)|||||||0.11
72406176|NCT02114879|144320999|SUPERIORITY|||||||0.91|||||||Wilcoxon (Mann-Whitney)|||||||0.91
72406177|NCT02114879|144321000|SUPERIORITY|||||||0.96||||||The p-value refers to the time by group interaction. The statistical significance in this test was p\<0.05.|Mixed Models Analysis|||This Primary analysis used a marginal model with time (baseline and discharge), condition (EMR vs SOC), and time x condition as fixed effects, with an unstructured covariance structure specified, based on Bayesian information criteria (BIC).||||0.96
72522748|NCT03180294|144575276|SUPERIORITY|||||||0.46||||||One-sided significance level 0.05|t-test, 1 sided|||Week 9||||0.46
72522749|NCT03180294|144575276|SUPERIORITY|||||||0.42||||||One-sided significance level 0.05|t-test, 1 sided|||Week 9||||0.42
72406178|NCT02114879|144321001|SUPERIORITY|||||||0.37||||||The p-value is calculated from a 2x2 Contingency Table consisting of rows that represent Discharged Home Vs Discharged to Institution and columns that represent the EMR and SOC groups.|Chi-squared|||||||0.37
72406179|NCT02114879|144321002|SUPERIORITY|||||||0.85||||||The p-value is calculated from a 2x2 Contingency Table consisting of rows that represent Yes/No Rehospitalization and columns that represent the EMR and SOC groups.|Chi-squared|||||||0.85
72522750|NCT03180294|144575277|SUPERIORITY|||||||0.24||||||One-side significance level 0.05|t-test, 1 sided|||||||0.24
72522751|NCT03180294|144575277|SUPERIORITY|||||||0.74||||||One-sided significance level 0.05|t-test, 1 sided|||||||0.74
72522752|NCT03180294|144575278|SUPERIORITY|||||||0.41||||||One-sided significance level 0.05|t-test, 1 sided|||Week 5||||0.41
72522753|NCT03180294|144575278|SUPERIORITY|||||||0.6||||||One-sided significance level 0.05|t-test, 1 sided|||Week 5||||0.60
72406180|NCT03400033|144321041|NON_INFERIORITY|Non-inferiority was to be established if the lower limit of the two-sided 95 percent (%) confidence interval (CI) for the treatment difference is greater than the pre-specified non-inferiority margin of -0.75 g/dL.|Least square (LS) mean difference|-0.05|||||TWO_SIDED|95.0|-0.21|0.1||||||||0.10|-0.21|
72406181|NCT03400033|144321042|SUPERIORITY||LS mean difference|-8.12||||0.3354|TWO_SIDED|95.0|-45.66|29.41|||ANCOVA|||||29.41|-45.66|0.3354
72406182|NCT03400033|144321043|NON_INFERIORITY|Non-inferiority was to be established if the lower limit of the two-sided 95% CI for the treatment difference is greater than the pre-specified non-inferiority margin of -0.75 g/dL.|LS mean difference|-0.14|||||TWO_SIDED|95.0|-0.37|0.1||||||||0.10|-0.37|
72406183|NCT03400033|144321044|NON_INFERIORITY|Non-inferiority was to be established if the lower limit of the two-sided 95% CI for the treatment difference was above the non-inferiority margin of - 15%.|Median Difference (Final Values)|11.18||||0.0034|TWO_SIDED|95.0|2.83|19.56|||Van Elteren's test||Hodges-Lehmann Estimate of Treatment Difference has been reported.|||19.56|2.83|0.0034
72406184|NCT03400033|144321045|OTHER||Difference in response rate|0.1645||||0.0007|TWO_SIDED|95.0|0.06|0.27|||Cochran-Mantel-Haenszel|||||0.27|0.06|0.0007
72406185|NCT03400033|144321046|OTHER||Hazard Ratio (HR)|1.06||||0.5308|TWO_SIDED|95.0|0.26|4.22|||Wald test||Hazard ratio is estimated using a Cox proportional hazard regression model adjusted for treatment group and region.|||4.22|0.26|0.5308
72406186|NCT03400033|144321047|SUPERIORITY||LS mean difference|-3.73||||0.083|TWO_SIDED|95.0|-9.03|1.56|||MMRM||SBP|||1.56|-9.03|0.083
72406187|NCT03400033|144321047|SUPERIORITY||LS mean difference|-2.23||||0.057|TWO_SIDED|95.0|-4.99|0.54|||MMRM||DBP|||0.54|-4.99|0.057
72406188|NCT03400033|144321047|SUPERIORITY||LS mean difference|-2.6||||0.059|TWO_SIDED|95.0|-5.86|0.67|||MMRM||MAP|||0.67|-5.86|0.059
72406189|NCT03400033|144321048|SUPERIORITY||Mean Difference (Net)|-0.5||||0.407|TWO_SIDED|95.0|-4.73|3.72|||ANCOVA||SBP|||3.72|-4.73|0.407
72522754|NCT03180294|144575278|SUPERIORITY|||||||0.9||||||One-sided significance level 0.05|t-test, 1 sided|||Week 9||||0.90
72522755|NCT03180294|144575278|SUPERIORITY|||||||0.79||||||One-sided significance level 0.05|t-test, 1 sided|||Week 9||||0.79
72522756|NCT03180294|144575279|SUPERIORITY|||||||0.41||||||One-sided significance level 0.05|t-test, 1 sided|||Week 5||||0.41
72522757|NCT03180294|144575279|SUPERIORITY|||||||0.35||||||One-sided significance level 0.05|t-test, 1 sided|||Week 5||||0.35
72522758|NCT03180294|144575279|SUPERIORITY|||||||0.83||||||One-sided significance level 0.05|t-test, 1 sided|||Week 9||||0.83
72522759|NCT03180294|144575279|SUPERIORITY|||||||0.79||||||One-sided significance level 0.05|t-test, 1 sided|||Week 9||||0.79
72522760|NCT03180294|144575280|SUPERIORITY|||||||0.78||||||One-sided significance level 0.05|t-test, 1 sided|||Week 5||||0.78
72522761|NCT03180294|144575280|SUPERIORITY|||||||0.51||||||One-sided significance level 0.05|t-test, 1 sided|||Week 5||||0.51
72522762|NCT03180294|144575280|SUPERIORITY|||||||0.49||||||One-sided significance level 0.05|t-test, 1 sided|||Week 9||||0.49
72522763|NCT03180294|144575280|SUPERIORITY|||||||0.5||||||One-sided significance level 0.05|t-test, 1 sided|||Week 9||||0.50
72522764|NCT03180294|144575281|SUPERIORITY|||||||0.71|||||||Chi-squared|One-sided significance level 0.05||||||0.71
72522765|NCT03180294|144575281|SUPERIORITY|||||||0.34|||||||Chi-squared|One-sided significance level 0.05||||||0.34
72522766|NCT03180294|144575282|SUPERIORITY|||||||0.23||||||One-sided significance level 0.05|t-test, 1 sided|||||||0.23
72522767|NCT03180294|144575282|SUPERIORITY|||||||0.25||||||One-sided significance level 0.05|t-test, 1 sided|||||||0.25
72522768|NCT02527564|144575344|OTHER|||||||0.1||||||A p-value of \<0.05 would be considered statistically significant.|Paired 2-sided t-test|||Within group change at week 1 - suvorexant (double-blind)||||0.10
72522769|NCT02527564|144575344|OTHER|||||||0.57||||||A p-value of \<0.05 would be considered statistically significant.|Paired 2-sided t-test|||Within group change at week 1- placebo (double-blind) group||||0.57
72522770|NCT02527564|144575344|OTHER|||||||0.44||||||A p-value of \<0.05 would be considered statistically significant.|Unpaired 2-sided t-test|||Between group change at week 1||||0.44
72522771|NCT02527564|144575345|OTHER|||||||0.035||||||A p-value of \<0.05 would be considered significantly significant.|Paired 2-sided t-test|||Within group change at week 1 - suvorexant (double-blind)||||0.035
72570384|NCT02504671|144670136|OTHER||Difference|13.5|||||TWO_SIDED|95.0|2.5|24.5|||||Index based ACR/EULAR, Week 36. Difference to Placebo for Week 36 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||24.5|2.5|
72570385|NCT02504671|144670136|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||Index based ACR/EULAR, Week 36. Difference to Placebo for Week 36 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
72570386|NCT02504671|144670136|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||Index based ACR/EULAR, Week 40. Difference to Placebo for Week 40 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
72570387|NCT02504671|144670136|OTHER||Difference|13.5|||||TWO_SIDED|95.0|2.5|24.5|||||Index based ACR/EULAR, Week 40. Difference to Placebo for Week 40 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||24.5|2.5|
72406190|NCT03400033|144321048|SUPERIORITY||Mean Difference (Net)|-1.05||||0.179|TWO_SIDED|95.0|-3.29|1.19|||ANCOVA||DBP|||1.19|-3.29|0.179
72406191|NCT03400033|144321048|SUPERIORITY||Mean Difference (Net)|-0.86||||0.261|TWO_SIDED|95.0|-3.5|1.78|||ANCOVA||MAP|||1.78|-3.50|0.261
72522772|NCT02527564|144575345|OTHER|||||||0.55|||||||Paired 2-sided t-test|A p-value of \<0.05 would be considered statistically significant.||Within group change at week 1- placebo (double-blind) group||||0.55
72522773|NCT02527564|144575345|OTHER|||||||0.89||||||A p-value of \<0.05 would be considered statistically significant.|Paired 2-sided t-test|||Between group change at week 1||||0.89
72522774|NCT02527564|144575346|OTHER|||||||0.97||||||A p-value of \<0.05 would be considered significantly significant.|Paired 2-sided t-test|||Within group change at month 3 - suvorexant (open-label)||||0.97
72570388|NCT02504671|144670136|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||Index based ACR/EULAR, Week 44. Difference to Placebo for Week 44 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
72570389|NCT02504671|144670136|OTHER||Difference|8.1|||||TWO_SIDED|95.0|-0.7|16.9|||||Index based ACR/EULAR, Week 44. Difference to Placebo for Week 44 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||16.9|-0.7|
72570390|NCT02504671|144670136|OTHER||Difference|10.8|||||TWO_SIDED|95.0|0.8|20.8|||||Index based ACR/EULAR, Week 48. Difference to Placebo for Week 48 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||20.8|0.8|
72570391|NCT02504671|144670136|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||Index based ACR/EULAR, Week 48. Difference to Placebo for Week 48 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
72570392|NCT02504671|144670136|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||Index based ACR/EULAR, Week 52. Difference to Placebo for Week 52 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
72570393|NCT02504671|144670136|OTHER||Difference|8.1|||||TWO_SIDED|95.0|-0.7|16.9|||||Index based ACR/EULAR, Week 52. Difference to Placebo for Week 52 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||16.9|-0.7|
72570394|NCT02504671|144670136|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||Index based ACR/EULAR, Week 62 (follow-up). Difference to Placebo for Week 62 (follow-up) is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
72406192|NCT03400033|144321049|OTHER||Ratio of exacerbation rate|0.7||||0.0093|TWO_SIDED|95.0|0.52|0.94|||Negative binomial model|||||0.94|0.52|0.0093
72406193|NCT03400033|144321051|SUPERIORITY||LS mean difference|-0.15||||0.0323|TWO_SIDED|95.0|-0.32|0.01|||MMRM||Week 8|||0.01|-0.32|0.0323
72406194|NCT03400033|144321051|SUPERIORITY||LS mean difference|-0.12||||0.0921|TWO_SIDED|95.0|-0.29|0.06|||MMRM||Week 12|||0.06|-0.29|0.0921
72406195|NCT03400033|144321051|SUPERIORITY||LS mean difference|-0.11||||0.1291|TWO_SIDED|95.0|-0.29|0.08|||MMRM||Week 28|||0.08|-0.29|0.1291
72406196|NCT03400033|144321051|SUPERIORITY||LS mean difference|-0.15||||0.0859|TWO_SIDED|95.0|-0.36|0.06|||MMRM||Week 52|||0.06|-0.36|0.0859
72522775|NCT02527564|144575347|OTHER|||||||0.28||||||A p-value of \<0.05 would be considered significantly significant.|Paired 2-sided t-test|||Within group change at month 3 - suvorexant (open-label)||||0.28
72522776|NCT00420342|144575348|SUPERIORITY_OR_OTHER|||||||0.1182||95.0||||0.5 mg DRSP / 1.0 mg E2 vs 1.5 mg MPA / 0.3 mg CEE.|ANCOVA|No adjustments made for multiple comparisons||Pairwise comparisons among all three treatment groups were performed; both DRSP / E2 group vs MPA /CEE, and the two active doses against each other. Null hypotheses were that there were no differences between groups for each of the three pairwise comparison. Analysis of variance model was used, with terms for treatment, center, and baseline BP values.||||0.1182
72522777|NCT00420342|144575348|SUPERIORITY_OR_OTHER|||||||0.2224||95.0||||2.0 mg DRSP / 1.0 mg E2 vs 1.5mg MPA / 0.3 mg CEE.|ANCOVA|No adjustments made for multiple comparisons||Pairwise comparisons among all three treatment groups were performed; both DRSP / E2 group vs MPA /CEE, and the two active doses against each other. Null hypotheses were that there were no differences between groups for each of the three pairwise comparison. Analysis of variance model was used, with terms for treatment, center, and baseline BP values.||||0.2224
72570395|NCT02504671|144670136|OTHER||Difference|13.5|||||TWO_SIDED|95.0|2.5|24.5|||||Index based ACR/EULAR, Week 62 (follow-up). Difference to Placebo for Week 62 (follow-up) is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||24.5|2.5|
72570396|NCT02504671|144670137|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||Boolean based ACR/EULAR, Week 8. Difference to Placebo for Week 8 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
72570397|NCT02504671|144670137|OTHER||Difference|8.1|||||TWO_SIDED|95.0|-0.7|16.9|||||Boolean based ACR/EULAR, Week 12. Difference to Placebo for Week 12 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||16.9|-0.7|
72570398|NCT02504671|144670137|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||Difference to Placebo for Week 16 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
72570399|NCT02504671|144670137|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||Boolean based ACR/EULAR, Week 16. Difference to Placebo for Week 16 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
72406197|NCT02741115|144321064|SUPERIORITY||Mean Difference (Final Values)|0.64|STANDARD_ERROR_OF_MEAN|0.377||0.092|TWO_SIDED|||||LS mean was the estimated treatment difference from the analysis model.|ANCOVA|ANCOVA fixed factors: ventricular morphology and treatment group with a continuous covariate of Baseline maximal VO2. LOCF imputation used.||It was estimated that a sample size of 198 participants per group would provide 90% power to detect a mean treatment group difference in change from baseline to Week 26 in maximal VO2 scores of 10% (ie, an improvement of 2.8 mL/kg/min in the udenafil group compared to 0 in the control group, assuming a Type I error of 0.05 and standard deviation of 7.235). A difference of 2.8, equivalent to a 10% increase from a baseline of 28 mL/kg/min, represents approximately 0.4 standard deviations.||||0.092
72406198|NCT02741115|144321065|SUPERIORITY|LS mean differences between treatment groups were analyzed.|Mean Difference (Final Values)|-0.03|STANDARD_ERROR_OF_MEAN|0.014||0.024|TWO_SIDED|||||LS mean was the estimated treatment difference from the analytical model.|ANCOVA|Fixed factors: ventricular morphology and treatment group with a continuous covariate of Baseline maximal VO2.||||||0.024
72406199|NCT02741115|144321066|SUPERIORITY||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.591||0.591|TWO_SIDED||||||ANCOVA|||||||0.591
72406200|NCT02741115|144321067|SUPERIORITY||Mean Difference (Final Values)|0.13|STANDARD_ERROR_OF_MEAN|0.094||0.169|TWO_SIDED||||||ANCOVA|||||||0.169
72406201|NCT02741115|144321068|SUPERIORITY|LS mean differences between treatment groups were analyzed.|Median Difference (Final Values)|0.78|STANDARD_ERROR_OF_MEAN|0.308||0.012|TWO_SIDED|||||LS mean was the estimated treatment mean difference from the analysis model.|ANCOVA|Fixed factors: ventricular morphology and treatment group, with a continuous covariate of Baseline maximal VO2. LOCF imputation.||||||0.012
72406202|NCT02741115|144321069|SUPERIORITY|LS mean differences between treatment groups were analyzed.|Mean Difference (Final Values)|3.2|STANDARD_ERROR_OF_MEAN|1.46||0.029|TWO_SIDED|||||LS mean was the estimated treatment difference in the analysis model.|ANCOVA|Fixed factors: ventricular morphology and treatment group, with a continuous covariate of Baseline maximal VO2. LOCF imputation.||||||0.029
72406203|NCT02741115|144321070|SUPERIORITY|LS mean differences between treatment groups were analyzed.|Mean Difference (Final Values)|-0.82|STANDARD_ERROR_OF_MEAN|0.321||0.011|TWO_SIDED|||||LS mean was the estimated treatment difference from the analysis model.|ANCOVA|Fixed factors: ventricular morphology and treatment group with a continuous covariate of Baseline maximal VO2. LOCF imputation.||||||0.011
72406204|NCT02741115|144321071|SUPERIORITY|LS mean differences between treatment groups were analyzed.|Mean Difference (Final Values)|0.35|STANDARD_ERROR_OF_MEAN|0.903||0.696|TWO_SIDED||||||ANCOVA|Fixed factors: ventricular morphology and treatment group with a continuous covariate of Baseline VO2. LOCF imputation.||||||0.696
72522778|NCT00420342|144575348|SUPERIORITY_OR_OTHER|||||||0.6929||95.0||||0.5 mg DRSP / 1.0 mg E2 vs 2.0 mg DRSP / 1.0 mg E2.|ANCOVA|No adjustments made for multiple comparisons||Pairwise comparisons among all three treatment groups were performed; both DRSP / E2 group vs MPA /CEE, and the two active doses against each other. Null hypotheses were that there were no differences between groups for each of the three pairwise comparison. Analysis of variance model was used, with terms for treatment, center, and baseline BP values.||||0.6929
72522779|NCT00420342|144575349|SUPERIORITY_OR_OTHER|||||||0.0702||95.0||||0.5 mg DRSP / 1.0 mg E2 vs 1.5 mg MPA / 0.3 mg CEE.|ANCOVA|No adjustments made for multiple comparisons||Pairwise comparisons among all three treatment groups were performed; both DRSP / E2 group vs MPA /CEE, and the two active doses against each other. Null hypotheses were that there were no differences between groups for each of the three pairwise comparison. Analysis of variance model was used, with terms for treatment, center, and baseline BP values.||||0.0702
72406205|NCT02741115|144321072|SUPERIORITY|LS mean differences between treatment groups were analyzed.|Mean Difference (Final Values)|0.14|STANDARD_ERROR_OF_MEAN|1.319||0.915|TWO_SIDED|||||LS mean was the estimated treatment difference from the analysis model.|ANCOVA|Fixed factors: ventricular morphology and treatment group with a continuous covariate of Baseline maximal VO2. LOCF imputation.||||||0.915
72406206|NCT02741115|144321073|SUPERIORITY||Mean Difference (Final Values)|0.19|STANDARD_ERROR_OF_MEAN|1.363||0.891|TWO_SIDED|||||LS mean was the estimated treatment difference from the analysis model.|ANCOVA|Fixed factors: ventricular morphology and treatment group with a continuous covariate of Baseline maximal VO2. LOCF imputation.||LS mean differences between treatment groups were analyzed.||||0.891
72570400|NCT02504671|144670137|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||Boolean based ACR/EULAR, Week 20. Difference to Placebo for Week 20 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
72570401|NCT02504671|144670137|OTHER||Difference|8.1|||||TWO_SIDED|95.0|-0.7|16.9|||||Boolean based ACR/EULAR, Week 20. Difference to Placebo for Week 20 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||16.9|-0.7|
72406207|NCT02741115|144321074|SUPERIORITY|LS mean differences between treatment groups were analyzed.|Mean Difference (Final Values)|0.44|STANDARD_ERROR_OF_MEAN|1.1||0.691|TWO_SIDED|||||LS mean was the estimated treatment difference from the analysis model.|ANCOVA|Fixed factors: ventricular morphology and treatment group, with a continuous covariate of Baseline physical functioning (child reported)||||||0.691
72406208|NCT02741115|144321075|SUPERIORITY|LS mean differences between treatment groups were analyzed.|Mean Difference (Final Values)|0.03|STANDARD_ERROR_OF_MEAN|1.544||0.985|TWO_SIDED|||||LS mean was the estimated treatment difference from the analysis model.|ANCOVA|Fixed factors: ventricular morphology and treatment group with a continuous covariate of Baseline physical functioning (parent reported).||||||0.985
72406209|NCT02741115|144321076|SUPERIORITY|LS mean differences between treatment groups were analyzed.|Mean Difference (Final Values)|1.14|STANDARD_ERROR_OF_MEAN|1.039||0.273|TWO_SIDED|||||LS mean was the estimated treatment difference from the analysis model.|ANCOVA|Fixed factors: ventricular morphology and treatment group with a continuous covariate of Baseline psychosocial health summary score (child reported).||||||0.273
72406210|NCT02741115|144321077|SUPERIORITY|LS mean differences between treatment groups were analyzed.|Mean Difference (Final Values)|-0.06|STANDARD_ERROR_OF_MEAN|1.327||0.966|TWO_SIDED|||||LS mean was the estimated treatment difference from the analysis model.|ANCOVA|Fixed factors: ventricular morphology and treatment group with a continuous covariate of Baseline psychosocial health summary score (parent reported).||||||0.966
72570402|NCT02504671|144670137|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||Boolean based ACR/EULAR, Week 24. Difference to Placebo for Week 24 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
72522780|NCT00420342|144575349|SUPERIORITY_OR_OTHER|||||||0.198||95.0||||2.0 mg DRSP / 1.0 mg E2 vs 1.5mg MPA / 0.3 mg CEE.|ANCOVA|No adjustments made for multiple comparisons||Pairwise comparisons among all three treatment groups were performed; both DRSP / E2 group vs MPA /CEE, and the two active doses against each other. Null hypotheses were that there were no differences between groups for each of the three pairwise comparison. Analysis of variance model was used, with terms for treatment, center, and baseline BP values.||||0.1980
72522781|NCT00420342|144575349|SUPERIORITY_OR_OTHER|||||||0.5777||95.0||||0.5 mg DRSP / 1.0 mg E2 vs 2.0 mg DRSP / 1.0 mg E2.|ANCOVA|No adjustments made for multiple comparisons||Pairwise comparisons among all three treatment groups were performed; both DRSP / E2 group vs MPA /CEE, and the two active doses against each other. Null hypotheses were that there were no differences between groups for each of the three pairwise comparison. Analysis of variance model was used, with terms for treatment, center, and baseline BP values.||||0.5777
72522782|NCT01665872|144575367|EQUIVALENCE|A Wilcoxon-Mann-Whitney test was used to test for equivalence. A p-value of 0.05 was used to determine if the difference falls out of the equivalence limits.||||||0.172|||||||t-test, 2 sided|||||||0.172
72522783|NCT01665872|144575368|EQUIVALENCE|A Wilcoxon-Mann-Whitney test was used to test for equivalence. A p-value of 0.05 was used to determine if the difference falls out of the equivalence limits.||||||0.5337|||||||Wilcoxon (Mann-Whitney)|||Are CES-D scores at 12 months different between groups?||||0.5337
72522784|NCT01665872|144575369|EQUIVALENCE|A Wilcoxon-Mann-Whitney test was used to test for equivalence. A p-value of 0.05 was used to determine if the difference falls out of the equivalence limits.||||||0.092||||||This test looks at a difference in Parental Distress at the 12 month follow-up between groups.|Wilcoxon (Mann-Whitney)|||||||0.0920
72522785|NCT01665872|144575369|EQUIVALENCE|A Wilcoxon-Mann-Whitney test was used to test for equivalence. A p-value of 0.05 was used to determine if the difference falls out of the equivalence limits.||||||0.3352||||||This test looks at a difference in Parent-Child Dysfunctional Interaction at the 12 month follow-up between groups.|Wilcoxon (Mann-Whitney)|||||||0.3352
72522786|NCT01665872|144575369|EQUIVALENCE|A Wilcoxon-Mann-Whitney test was used to test for equivalence. A p-value of 0.05 was used to determine if the difference falls out of the equivalence limits.||||||0.0404||||||This test looks at a difference in Difficult Child at the 12 month follow-up between groups.|Wilcoxon (Mann-Whitney)|||||||0.0404
72522787|NCT01665872|144575369|EQUIVALENCE|A Wilcoxon-Mann-Whitney test was used to test for equivalence. A p-value of 0.05 was used to determine if the difference falls out of the equivalence limits.||||||0.0915||||||This test looks at a difference in PSI total score (percentile) at the 12 month follow-up between groups.|Wilcoxon (Mann-Whitney)|||||||0.0915
72522788|NCT01665872|144575370|EQUIVALENCE|Chi-square was used with a p-value of 0.05 to determine if the difference was statistically greater than 0.||||||0.2914|||||||Chi-squared|||||||0.2914
72522789|NCT01366534|144575372|OTHER||Vaccine Efficacy Maentel-Haenzel Method|-17.6||||0.7675|TWO_SIDED|95.0|-107.4|33.3|||2-sided Fisher Exact test||Pre-defined futility criteria for efficacy: point estimate of increase of VE in Ad35.CS.01 Group over GSK257049 Group less than 0%|Comparison of the efficacy (occurrence of P. falciparum parasitemia, assessed by blood slide) of an immunization regimen comprising of one dose of Ad35.CS.01 vaccine followed one month later by 2 doses of GSK257049 vaccine administered at one month intervals, with that of 3 doses of GSK257049 vaccine administered at one month intervals, in healthy malaria-naïve volunteers aged 18-50 years in the sporozoite challenge model.||33.3|-107.4|0.7675
72570403|NCT02504671|144670137|OTHER||Difference|8.1|||||TWO_SIDED|95.0|-0.7|16.9|||||Boolean based ACR/EULAR, Week 24. Difference to Placebo for Week 24 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||16.9|-0.7|
72570404|NCT02504671|144670137|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||Boolean based ACR/EULAR, Week 28. Difference to Placebo for Week 28 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
72570405|NCT02504671|144670137|OTHER||Difference|8.1|||||TWO_SIDED|95.0|-0.7|16.9|||||Boolean based ACR/EULAR, Week 28. Difference to Placebo for Week 28 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||16.9|-0.7|
72522790|NCT01366534|144575372|OTHER||Vaccine Efficacy: Maentel-Haenzel Method|44.0||||0.0066|TWO_SIDED|95.0|20.7|60.4|||2-sided Fisher Exact test|||Comparison of the efficacy (occurrence of P. falciparum parasitemia, assessed by blood slide) of an immunization regimen comprising of one dose of Ad35.CS.01 vaccine followed one month later by 2 doses of GSK257049 vaccine administered at 1 month intervals, with that of 3 doses of GSK257049 vaccine administered at one month intervals, in healthy malaria-naïve volunteers aged 18-50 years in the sporozoite challenge model.||60.4|20.7|0.0066
72522791|NCT01366534|144575372|OTHER||Vaccine Efficacy: Maentel-Haenzel Method|52.4||||0.0021|TWO_SIDED|95.0|25.4|69.6|||2-sided Fisher Exact test|||Comparison of the efficacy (occurrence of P. falciparum parasitemia, assessed by blood slide) of an immunization regimen comprising of one dose of Ad35.CS.01 vaccine followed one month later by 2 doses of GSK257049 vaccine administered at 1 month intervals, with that of 3 doses of GSK257049 vaccine administered at one month intervals, in healthy malaria-naïve volunteers aged 18-50 years in the sporozoite challenge model.||69.6|25.4|0.0021
72570406|NCT02504671|144670137|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||Boolean based ACR/EULAR, Week 32. Difference to Placebo for Week 32 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
72570407|NCT02504671|144670137|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||Boolean based ACR/EULAR, Week 32. Difference to Placebo for Week 32 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
72570408|NCT02504671|144670137|OTHER||Difference|8.1|||||TWO_SIDED|95.0|-0.7|16.9|||||Boolean based ACR/EULAR, Week 36. Difference to Placebo for Week 36 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||16.9|-0.7|
72570409|NCT02504671|144670137|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||Boolean based ACR/EULAR, Week 36. Difference to Placebo for Week 36 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
72570410|NCT02504671|144670137|OTHER||Difference|8.1|||||TWO_SIDED|95.0|-0.7|16.9|||||Boolean based ACR/EULAR, Week 40. Difference to Placebo for Week 40 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||16.9|-0.7|
72570411|NCT02504671|144670137|OTHER||Difference|8.1|||||TWO_SIDED|95.0|-0.7|16.9|||||Boolean based ACR/EULAR, Week 40. Difference to Placebo for Week 40 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||16.9|-0.7|
72522792|NCT02565576|144575387|SUPERIORITY||estimate of contrast posterior median|-1.14|||||TWO_SIDED|90.0|-3.41|1.14|||bayesian|||Primary analysis was performed on the PD analysis set. Changes from baseline in QMG scores at Week 25 were analyzed using a Bayesian model. The model investigated effects for treatment (CFZ533 or placebo) and baseline QMG score. A difference of 3 points on the mean change in QMG score between CFZ533 and placebo was deemed a clinical meaningful effect.||1.14|-3.41|
72522793|NCT03185819|144575419|SUPERIORITY||Difference of LS Means|-5.8|STANDARD_ERROR_OF_MEAN|2.74|=|0.037|TWO_SIDED|95.0|-11.19|-0.35||Threshold for significance for p-value was 0.05.|ANCOVA|||A pooled (54 mg and 84 mg) sequential multiple testing procedure was implemented to control type I error by comparing pooled data against midazolam + placebo matched to esketamine nasal spray.||-0.35|-11.19|= 0.037
72406211|NCT02741115|144321078|SUPERIORITY|LS mean differences between treatment groups were analyzed.|Mean Difference (Final Values)|-0.38|STANDARD_ERROR_OF_MEAN|1.011||0.706|TWO_SIDED|||||LS mean was the estimated treatment difference from the analysis model.|ANCOVA|Fixed factors: ventricular morphology and treatment group with a continuous covariate of Baseline cardiac module scale (Treatment II).||||||0.706
72522794|NCT03185819|144575419|SUPERIORITY||Difference of LS Mean|-5.7|STANDARD_ERROR_OF_MEAN|3.65|=|0.123|TWO_SIDED|95.0|-12.91|1.55||Threshold for significance for p-value was 0.05.|ANCOVA|||Individual esketamine dose (84 mg versus medazolam + esketamine matched placebo) independent testing was planned to be performed after pooled (56 mg + 84 mg) analysis.||1.55|-12.91|= 0.123
72522795|NCT03185819|144575419|SUPERIORITY||Difference of LS Means|-5.9|STANDARD_ERROR_OF_MEAN|3.23|=|0.072|TWO_SIDED|95.0|-12.25|0.53||Threshold for significance for p-value was 0.05.|ANCOVA|||Individual esketamine dose (56 mg versus medazolam + esketamine matched placebo) independent testing was planned to be performed after pooled (56 mg + 84 mg) analysis.||0.53|-12.25|= 0.072
72522796|NCT03185819|144575419|SUPERIORITY||Difference of LS Means|-2.4|STANDARD_ERROR_OF_MEAN|3.35|||TWO_SIDED|95.0|-9.08|4.19||||||||4.19|-9.08|
72522797|NCT03375203|144575431|OTHER||Back-transformed Least Square Mean Ratio|0.88|||=|0.346|TWO_SIDED|90.0|0.7|1.1|||ANCOVA|||||1.10|0.70|= 0.346
72522798|NCT03375203|144575431|OTHER||Back-transformed Least Square Mean Ratio|0.64|||=|0.001|TWO_SIDED|90.0|0.51|0.81|||ANCOVA|||||0.81|0.51|= 0.001
72522799|NCT03375203|144575431|OTHER||Back-transformed Least Square Mean Ratio|0.51|||<|0.001|TWO_SIDED|90.0|0.41|0.64|||ANCOVA|||||0.64|0.41|< 0.001
72570412|NCT02504671|144670137|OTHER||Difference|10.8|||||TWO_SIDED|95.0|0.8|20.8|||||Boolean based ACR/EULAR, Week 44. Difference to Placebo for Week 44 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||20.8|0.8|
72522800|NCT03375203|144575431|OTHER|||||||0|||||||MCP-mod|||||||0.000
72522801|NCT03321526|144575478|SUPERIORITY|||||||0.5355|TWO_SIDED||||||Log Rank|||||||0.5355
72522802|NCT01872897|144575570|SUPERIORITY||Mean Difference (Final Values)|-9.79||||0.0003|TWO_SIDED|95.0|-14.85|-4.74|||Mixed Models Analysis|||||-4.74|-14.85|0.0003
72522803|NCT01872897|144575571|SUPERIORITY||Mean Difference (Final Values)|-15.76|||<|0.0001|TWO_SIDED|95.0|-22.82|-8.71|||Mixed Models Analysis|||||-8.71|-22.82|<0.0001
72522804|NCT01872897|144575572|SUPERIORITY||Median Difference (Final Values)|-19.4||||0.0004|TWO_SIDED|95.0|-29.6|-9.2|||Mixed Models Analysis|||||-9.2|-29.6|0.0004
72522805|NCT01872897|144575573|SUPERIORITY||Mean Difference (Final Values)|-16.3||||0.0019|TWO_SIDED|95.0|-26.2|-6.4|||Mixed Models Analysis|||||-6.4|-26.2|0.0019
72570413|NCT02504671|144670137|OTHER||Difference|8.1|||||TWO_SIDED|95.0|-0.7|16.9|||||Boolean based ACR/EULAR, Week 44. Difference to Placebo for Week 44 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||16.9|-0.7|
72406212|NCT02741115|144321079|SUPERIORITY|LS mean differences between treatment groups were analyzed.|Mean Difference (Final Values)|1.5|STANDARD_ERROR_OF_MEAN|1.707||0.382|TWO_SIDED|||||LS mean was the estimated treatment difference from the analysis model.|ANCOVA|Fixed factors: ventricular morphology and treatment group with a continuous covariate of Baseline cardiac module scale (perceived physical appearance)||||||0.382
72522806|NCT01872897|144575574|SUPERIORITY||Mean Difference (Final Values)|-0.8||||0.029|TWO_SIDED|95.0|-1.6|-0.1|||Mixed Models Analysis|||||-0.1|-1.6|0.0290
72522807|NCT01872897|144575575|SUPERIORITY||Mean Difference (Final Values)|-14.4|||<|0.0001|TWO_SIDED|95.0|-20.57|-8.23|||Mixed Models Analysis|||||-8.23|-20.57|<0.0001
72522808|NCT01872897|144575576|SUPERIORITY||Mean Difference (Final Values)|-23.37|||<|0.0001|TWO_SIDED|95.0|-31.55|-15.19|||Mixed Models Analysis|||||-15.19|-31.55|<0.0001
72522809|NCT01872897|144575577|SUPERIORITY||Mean Difference (Final Values)|-7.3|||<|0.0001|TWO_SIDED|95.0|-10.0|-4.6|||Mixed Models Analysis|||||-4.6|-10.0|<0.0001
72522810|NCT01872897|144575578|SUPERIORITY||Mean Difference (Final Values)|-6.4||||0.0001|TWO_SIDED|95.0|-9.4|-3.3|||Mixed Models Analysis|||||-3.3|-9.4|0.0001
72522811|NCT01872897|144575579|SUPERIORITY||Mean Difference (Final Values)|-6.3||||0.0075|TWO_SIDED|95.0|-10.9|-1.8|||Mixed Models Analysis|||||-1.8|-10.9|0.0075
72522812|NCT01872897|144575580|SUPERIORITY||Mean Difference (Final Values)|-24.145||||0.0007|TWO_SIDED|95.0|-37.432|-10.858|||Mixed Models Analysis|||||-10.858|-37.432|0.0007
72522813|NCT04254796|144575581|OTHER|Calculation of the effect size (Cohen's d)|Cohen's d|0.27|||||TWO_SIDED|95.0|-0.13|0.68||||||The goal of the analysis was to measure the effect size of the change in the primary mechanistic outcome (Putamen structural node strength), with a Go/No-Go threshold of Cohen's d \> 0.20.||0.68|-0.13|
72522814|NCT02418585|144575583|SUPERIORITY||Difference of Least Square (LS) Means|-4.0|STANDARD_ERROR_OF_MEAN|1.69|=|0.02|TWO_SIDED|95.0|-7.31|-0.64|||Mixed Model for Repeated Measures|||||-0.64|-7.31|=0.020
72522815|NCT02418585|144575584|SUPERIORITY||Difference of Least Square (LS) Means|-3.5|||=|0.034|TWO_SIDED|95.0|-6.67|-0.26|||ANCOVA|||||-0.26|-6.67|=0.034
72522816|NCT02040857|144575599|OTHER|Exact binomial test||||||0.0011|||||||Exact binomial test|||Primary objective is treatment discontinuation rate at 2 yr for patients receiving Palbociclib therapy. If the true rate of discontinuation by two years is 48% or higher, treatment duration will be considered not feasible and not worthy of further study. If the rate of discontinuation is 33.3% or less, the 2 yr duration will be deemed feasible and worthy of further study. Using a one-sided alpha = 0.025, there is \> 90% power to reject the null hypothesis in favor of feasibility.||||0.0011
72522817|NCT04159701|144575605|SUPERIORITY||Mean Difference (Final Values)|2.94||||0.38|TWO_SIDED|95.0|-3.73|9.6|||Mixed Models Analysis|||||9.60|-3.73|0.380
72406213|NCT02741115|144321080|SUPERIORITY|LS mean differences between treatment groups were analyzed.|Mean Difference (Final Values)|1.91|STANDARD_ERROR_OF_MEAN|1.611||0.236|TWO_SIDED|||||LS mean was the estimated treatment difference from the analysis model.|ANCOVA|Fixed factors: ventricular morphology and treatment group with a continuous covariate of Baseline cardiac module scale (treatment anxiety).||||||0.236
72522818|NCT04159701|144575606|SUPERIORITY||Mean Difference (Final Values)|1.3||||0.415|TWO_SIDED|95.0|-1.89|4.5|||Mixed Models Analysis|||||4.50|-1.89|0.415
72522819|NCT04159701|144575607|SUPERIORITY||Mean Difference (Final Values)|1.72||||0.369|TWO_SIDED|95.0|-2.09|5.53|||Mixed Models Analysis|||||5.53|-2.09|0.369
72522820|NCT04159701|144575608|SUPERIORITY||Odds Ratio (OR)|0.61||||0.674|TWO_SIDED|95.0|0.14|2.7|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted by baseline UAS7 (\< 28 vs \>= 28) score.||||2.70|0.14|0.674
72522821|NCT04159701|144575609|SUPERIORITY||Odds Ratio (OR)|0.59||||0.674|TWO_SIDED|95.0|0.13|2.68|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted by baseline UAS7 (\< median vs \>= median) score.||||2.68|0.13|0.674
72522822|NCT00654420|144575626|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.86||||0.268|TWO_SIDED|95.0|0.47|1.57|||Finkelstein Proportional Hazards Model|||Finkelstein proportional hazards model for interval-censored data was used to assess treatment effect on PFS in Phase II. The hazard ratio with 95% confidence interval for the Dalotuzumab (10 mg/kg) + Erlotinib treatment arm compared to the Erlotinib treatment arm was reported.||1.57|0.47|0.268
72522823|NCT00654420|144575627|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.44||||0.879|TWO_SIDED|95.0|0.78|2.64|||Regression, Cox|||The treatment difference in survival between treatment groups was assessed by Cox regression. The estimated hazard ratio for treatment of the Dalotuzumab (10 mg/kg) + Erlotinib treatment arm compared to the Erlotinib treatment arm was reported from the Cox model.||2.64|0.78|0.879
72522824|NCT00654420|144575628|SUPERIORITY_OR_OTHER||Difference in Percentage|-2.8||||0.721|TWO_SIDED|95.0|-15.9|9.4|||Miettinen & Nurminen Method|||Miettinen and Nurminen's method for stratified data was used for comparison of percentage of participants with objective response (ORR) between the two treatment groups. Response rate calculation was based on full follow-up.||9.4|-15.9|0.721
72522825|NCT00471276|144575631|SUPERIORITY_OR_OTHER||Objective Response Rate (percent)|8.4|||||TWO_SIDED|95.0|3.5|16.6|||Exact 2-sided confidence interval|||||16.6|3.5|
72522826|NCT00471276|144575632|SUPERIORITY_OR_OTHER||Objective Response Rate (percent)|10.8|||||TWO_SIDED|95.0|5.1|19.6|||Exact 2-sided confidence interval|||||19.6|5.1|
72522827|NCT01332097|144575669|SUPERIORITY||Least squares mean difference|54.2|||||TWO_SIDED|95.0|-41.7|150.1||||||LS Mean difference: Treatment A vs. Treatment B, E, G \& I (placebo) Day 5||150.1|-41.7|
72522828|NCT01332097|144575669|SUPERIORITY||Least squares mean difference|-52.0|||||TWO_SIDED|95.0|-148.5|44.5||||||LS Mean difference: Treatment C vs. Treatment B, E, G \& I (placebo) Day 5||44.5|-148.5|
72522829|NCT01332097|144575669|SUPERIORITY||Least squares mean difference|5.5|||||TWO_SIDED|95.0|-96.0|106.9||||||LS Mean difference: Treatment D vs. Treatment B, E, G \& I (placebo) Day 5||106.9|-96.0|
72522830|NCT01332097|144575669|SUPERIORITY||Least squares mean difference|33.5|||||TWO_SIDED|95.0|-66.8|133.9||||||LS Mean difference: Treatment F vs. Treatment B, E, G \& I (placebo) Day 5||133.9|-66.8|
72522831|NCT01332097|144575669|SUPERIORITY||Least squares mean difference|99.8|||||TWO_SIDED|95.0|-2.4|202.0||||||LS Mean difference: Treatment H vs. Treatment B, E, G \& I (placebo) Day 5||202.0|-2.4|
72522832|NCT01332097|144575669|SUPERIORITY||Least squares mean difference|37.8|||||TWO_SIDED|95.0|-107.1|182.6||||||LS Mean difference: Treatment A vs. Treatment B, E, G \& I (placebo) Day 10||182.6|-107.1|
72570414|NCT02504671|144670137|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||Boolean based ACR/EULAR, Week 48. Difference to Placebo for Week 48 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
72522833|NCT01332097|144575669|SUPERIORITY||Least squares mean difference|-72.0|||||TWO_SIDED|95.0|-215.7|71.8||||||LS Mean difference: Treatment C vs. Treatment B, E, G \& I (placebo) Day 10||71.8|-215.7|
72522834|NCT01332097|144575669|SUPERIORITY||Least squares mean difference|-72.3|||||TWO_SIDED|95.0|-241.5|96.9||||||LS Mean difference: Treatment D vs. Treatment B, E, G \& I (placebo) Day 10||96.9|-241.5|
72522835|NCT01332097|144575669|SUPERIORITY||Least squares mean difference|-17.9|||||TWO_SIDED|95.0|-154.9|119.2||||||LS Mean difference: Treatment F vs. Treatment B, E, G \& I (placebo) Day 10||119.2|-154.9|
72522836|NCT01332097|144575669|SUPERIORITY||Least squares mean difference|123.6|||||TWO_SIDED|95.0|-15.8|263.0||||||LS Mean difference: Treatment H vs. Treatment B, E, G \& I (placebo) Day 10||263.0|-15.8|
72522837|NCT01248585|144575673|SUPERIORITY||Risk Difference (RD)|0.09|STANDARD_ERROR_OF_MEAN|0.053||0.05|TWO_SIDED|90.0|0.0|0.177||1-sided p-value.|Cochran-Mantel-Haenszel|||One-sided 0.05 level test with 90% power, 298 participants required.||0.177|0|0.05
72522838|NCT01248585|144575674|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|0.009||||0.432|TWO_SIDED|95.0|-0.08|0.1|||Cochran-Mantel-Haenszel|||||0.10|-0.08|0.432
72522839|NCT01248585|144575676|SUPERIORITY||Risk Difference (RD)|0.09||||0.15|TWO_SIDED|90.0|0.01|0.18||Fisher exact test.|Fisher Exact|||||0.18|0.01|0.15
72522840|NCT01248585|144575677|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.55||||0.07|TWO_SIDED|90.0|-5.06|3.97|||Wilcoxon (Mann-Whitney)|||||3.97|-5.06|0.07
72522841|NCT00880607|144575716|OTHER|Wilcoxon rank-sum test because the outcome variable was found to have a skewed distribution.|Median Difference (Final Values)|7.7||||0.27|TWO_SIDED|95.0|-5.8|21.2||Hodges-Lehmanne estimation method|Wilcoxon (Mann-Whitney)||Hodges-Lehmanne estimation method|||21.2|-5.8|.27
72522842|NCT00880607|144575717|OTHER|Log-rank test in Kaplan-Meier used.||||||0.42|TWO_SIDED|95.0|||||Log Rank|||||||.42
72522843|NCT00880607|144575719|OTHER|||||||0.08|||||||Chi-squared|||||||0.08
72522844|NCT00880607|144575720|OTHER|||||||0.3|||||||Chi-squared|||||||0.30
72522845|NCT00880607|144575721|OTHER|||||||0.07|||||||Chi-squared|||||||0.07
72522846|NCT00880607|144575722|OTHER|||||||0.31|||||||Chi-squared|||||||0.31
72522847|NCT02963766|144575725|SUPERIORITY||LS Mean difference (Final Values)|-1.3|||<|0.001|TWO_SIDED|95.0|-1.8|-0.7|||Mixed Models Analysis|||||-0.7|-1.8|<0.001
72522848|NCT02963766|144575726|SUPERIORITY||LS Mean difference (Final Values)|-1.0||||0.002|TWO_SIDED|95.0|-1.7|-0.4|||Mixed Models Analysis|||||-0.4|-1.7|0.002
72522849|NCT02963766|144575726|SUPERIORITY||LS Mean difference (Final Values)|-1.5|||<|0.001|TWO_SIDED|95.0|-2.2|-0.9|||Mixed Models Analysis|||||-0.9|-2.2|<0.001
72406214|NCT02741115|144321081|SUPERIORITY|LS mean differences between treatment groups were analyzed.|Mean Difference (Final Values)|-0.99|STANDARD_ERROR_OF_MEAN|1.622||0.543|TWO_SIDED|||||LS mean was the estimated treatment difference from the analysis model.|ANCOVA|Fixed factors: ventricular morphology and treatment group with a continuous covariate of Baseline cardiac module scale (cognitive problems).||||||0.543
72522850|NCT02963766|144575727|SUPERIORITY||LS Mean difference (Final Values)|-1.44||||0.021|TWO_SIDED|95.0|-2.65|-0.22|||Mixed Models Analysis|||||-0.22|-2.65|0.021
72406215|NCT02741115|144321082|SUPERIORITY|LS mean differences between treatment groups were analyzed.|Mean Difference (Final Values)|-1.66|STANDARD_ERROR_OF_MEAN|1.78||0.352|TWO_SIDED|||||LS mean was the estimated treatment difference from the analysis model.|ANCOVA|Fixed factors: ventricular morphology and treatment group with a continuous covariate of Baseline cardiac module scale (communication problems).||||||0.352
72406216|NCT02741115|144321083|SUPERIORITY|LS mean differences between treatment groups were analyzed.|Mean Difference (Final Values)|3.59|STANDARD_ERROR_OF_MEAN|5.684||0.533|TWO_SIDED|||||LS mean was the estimated treatment difference from the analysis model.|ANCOVA|Fixed factors of ventricular morphology and treatment group with a continuous covariate of Baseline total score (age 8-12, child reported).||||||0.533
72406217|NCT02741115|144321084|SUPERIORITY|LS mean differences between treatment groups were analyzed.|Mean Difference (Final Values)|1.84|STANDARD_ERROR_OF_MEAN|4.057||0.654|TWO_SIDED|||||LS mean was the estimated treatment difference from the analysis model.|ANCOVA|Fixed factors: ventricular morphology and treatment group with a continuous covariate of Baseline total score (age 8-12, parent reported).||||||0.654
72406218|NCT02741115|144321085|SUPERIORITY|LS mean differences between treatment groups were analyzed.|Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|1.069||0.963|TWO_SIDED|||||LS mean was the estimated treatment difference from the analysis model.|ANCOVA|Fixed factors: ventricular morphology and treatment group with a continuous covariate of Baseline total score (ages 13-18, child reported)||||||0.963
72406219|NCT02741115|144321086|SUPERIORITY|LS mean differences between treatment group were analyzed.|Mean Difference (Final Values)|1.36|STANDARD_ERROR_OF_MEAN|1.171||0.246|TWO_SIDED|||||LS mean was the estimated treatment difference from the analysis model.|ANCOVA|Fixed factors of ventricular morphology and treatment group with a continuous covariate of Baseline total score (ages 13-18, parent reported).||||||0.246
72522851|NCT02963766|144575727|SUPERIORITY||LS Mean difference (Final Values)|-2.51|||<|0.001|TWO_SIDED|95.0|-3.72|-1.29|||Mixed Models Analysis|||||-1.29|-3.72|<0.001
72522852|NCT02963766|144575727|SUPERIORITY||LS Mean difference (Final Values)|-1.97|||<|0.001|TWO_SIDED|95.0|-3.03|-0.91|||Mixed Models Analysis|||||-0.91|-3.03|<0.001
72570415|NCT02504671|144670137|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||Boolean based ACR/EULAR, Week 48. Difference to Placebo for Week 48 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
72570416|NCT02504671|144670137|OTHER||Difference|21.6|||||TWO_SIDED|95.0|0.4|42.8|||||Boolean based ACR/EULAR, Week 48. Difference to Placebo for Week 48 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||42.8|0.4|
72406220|NCT01101841|144321123|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Week 4 frequency|Rank transformed ANCOVA|||||||<0.0001
72406221|NCT01101841|144321123|SUPERIORITY_OR_OTHER|||||||0.0001||||||Week 12 frequency|Rank transformed ANCOVA|||||||0.0001
72406222|NCT01101841|144321124|SUPERIORITY_OR_OTHER|||||||0.0066||||||Week 24 persistence of effect|Logit model|||||||0.0066
72406223|NCT01101841|144321139|SUPERIORITY_OR_OTHER|||||||0.0368||||||Week 4 severity|Rank transformed ANCOVA|||||||0.0368
72406224|NCT01101841|144321139|SUPERIORITY_OR_OTHER|||||||0.0064||||||Week 12 severity|Rank transformed ANCOVA|||||||0.0064
72406225|NCT01167712|144321140|SUPERIORITY||Hazard Ratio (HR)|0.89|||||TWO_SIDED|95.0|0.74|1.06||||||Estimated hazard of first progression or death for weekly paclitaxel treatment relative to standard 3 week paclitaxel.||1.06|.74|
72406226|NCT01167712|144321141|SUPERIORITY||Hazard Ratio (HR)|0.94|||||TWO_SIDED|95.0|0.72|1.23||||||||1.23|.72|
72406227|NCT03633396|144321144|OTHER||Least Squares (LS) Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|1.98||0.944|TWO_SIDED|95.0|-4.05|3.77|||Mixed-model Repeated Measures (MMRM)|MMRM including fixed effects of treatment, history of plaque psoriasis, visit, treatment by visit interaction, and Baseline PPPASI score as covariate.|Least-squares mean difference = Imsidolimab - Placebo|The change from Baseline in PPPASI at Week 16 was analyzed using a a general linear mixed model for repeated measures (MMRM). The model included fixed effects for treatment, history of plaque psoriasis (Yes/No), visit, treatment by visit interaction, and Baseline PPPASI score as covariate.||3.77|-4.05|0.944
72406228|NCT03633396|144321146|OTHER||Odds Ratio (OR)|0.879|||||TWO_SIDED|95.0|0.288|2.686|||||Odds ratio from a logistic regression model including treatment as fixed effect, history of plaque psoriasis and Baseline PPPASI score as covariates and using multiple imputation for missing data.|||2.686|0.288|
72406229|NCT03633396|144321147|OTHER||Odds Ratio (OR)|2.6|||||TWO_SIDED|95.0|0.5|13.9|||||Odds ratio from a logistic regression model including treatment as fixed effect, history of plaque psoriasis and Baseline PPPIGA score as covariates and using multiple imputation for missing data.|||13.9|0.5|
72406230|NCT01896895|144321168|SUPERIORITY||LS mean difference|-1.2|||=|0.0004|TWO_SIDED|95.0|-1.9|-0.6|||ANCOVA|||The difference in change of JRS severity subscore between treatment groups was analyzed by an ANCOVA according to a hierarchical test procedure. First step of hierarchy is hypothesis of superiority of 50 unit dose group NT 201 compared to placebo. This was tested confirmatory (α=0.05, 2-sided) by an ANCOVA with treatment group, pooled site, and gender as fixed factors and baseline JRS severity subscore and age as covariates based on LS means comparison. Missing values were imputed by LOCF.||-0.6|-1.9|=0.0004
72522853|NCT02963766|144575728|SUPERIORITY||Odds Ratio (OR)|11.038|||<|0.001|TWO_SIDED|95.0|3.491|34.902|||Regression, Logistic|||||34.902|3.491|<0.001
72522854|NCT02963766|144575728|SUPERIORITY||Odds Ratio (OR)|11.666|||<|0.001|TWO_SIDED|95.0|3.653|37.253|||Regression, Logistic|||||37.253|3.653|<0.001
72522855|NCT02963766|144575728|SUPERIORITY||Odds Ratio (OR)|11.348|||<|0.001|TWO_SIDED|95.0|4.163|30.932|||Regression, Logistic|||||30.932|4.163|<0.001
72522856|NCT02963766|144575729|SUPERIORITY||LS Mean difference (Final Values)|-0.1||||0.689|TWO_SIDED|95.0|-0.7|0.5|||Mixed Models Analysis|||||0.5|-0.7|0.689
72522857|NCT02963766|144575729|SUPERIORITY||LS Mean difference (Final Values)|0.0||||0.924|TWO_SIDED|95.0|-0.6|0.5|||Mixed Models Analysis|||||0.5|-0.6|0.924
72522858|NCT02963766|144575729|SUPERIORITY||LS Mean difference (Final Values)|-0.1||||0.776|TWO_SIDED|95.0|-0.6|0.4|||Mixed Models Analysis|||||0.4|-0.6|0.776
72522859|NCT00499460|144575741|SUPERIORITY|The primary hypothesis being tested is that garlic powder treatment increases metabolic clearance of oxycodone through enzyme induction and results in lower exposure to oxycodone.|||||>|0.05||||||Significance probability for the treatment variable in the Generalized Linear Model|Generalized Estimating Equations|Response variable is oxycodone oral clearance. Explanatory variables include treatment, period and gender, along with their interaction terms.||||||>0.05
72522860|NCT00499460|144575742|SUPERIORITY|The secondary hypothesis being tested is that powder garlic treatment lowers Cold Pressor Test tolerance (i.e., diminished analgesic response) after oxycodone administration due to a more rapid metabolic clearance and lower exposure to oxycodone.|||||>|0.05||||||Significance probability for the treatment variable in the Generalized Linear Model|Generalized Estimating Equations|Response variable is log Tolerance AUC. Explanatory variables include treatment, period and gender, along with their interaction terms.||||||>0.05
72522861|NCT00499460|144575743|SUPERIORITY|The secondary hypothesis being tested is that garlic powder treatment lowers opioid side effects after oxycodone administration due to a more rapid metabolic clearance and lower exposure to oxycodone.|||||>|0.05||||||Significance probability for the treatment variable in the Generalized Linear Model|Generalized Estimating Equations|Response variable is total SSE rating score. Explanatory variables include treatment, period, time and gender, along with their interaction terms.||||||>0.05
72522862|NCT00499460|144575744|SUPERIORITY|The secondary hypothesis being tested is that garlic powder treatment lowers opioid side effects after oxycodone administration due to a more rapid metabolic clearance and lower exposure to oxycodone.|||||>|0.05||||||Significance probability for the treatment variable in the Generalized Linear Model|Generalized Estimating Equations|Response variable is total CASE rating score. Explanatory variables include treatment, period, time and gender, along with their interaction terms.||||||>0.05
72522863|NCT00499460|144575745|SUPERIORITY||||||>|0.05|||||||t-test, 1 sided|Garlic powder versus placebo||The secondary hypothesis being tested is that garlic powder induces CYP3A-mediated metabolism resulting in a lower oral midazolam AUC.||||>0.05
72522864|NCT00499460|144575746|SUPERIORITY|The secondary hypothesis being tested is that garlic powder treatment induces intestinal P-glycoprotein, reduces the bioavailability and hence AUC of orally administered digoxin.|||||>|0.05|||||||t-test, 1 sided|Garlic powder versus placebo||||||>0.05
72522865|NCT00814307|144575747|SUPERIORITY_OR_OTHER||Percent difference|39.04|||<|0.0001|TWO_SIDED|95.0|29.12|48.95||A step-down procedure was used to control for multiple comparisons. In order for the comparison to 5 mg to be statistically significant, the comparison to 10 mg had to be statistically significant.|Normal approximation|||Normal approximation for the difference in binomial proportions was used to test the superiority of each dose of CP-690,550 to placebo.||48.95|29.12|<0.0001
72522866|NCT00814307|144575747|SUPERIORITY_OR_OTHER||Percent difference|33.08|||<|0.0001|TWO_SIDED|95.0|23.04|43.13||A step-down procedure was used to control for multiple comparisons. In order for the comparison to 5 mg to be statistically significant, the comparison to 10 mg had to be statistically significant.|Normal approximation|||Normal approximation for the difference in binomial proportions was used to test the superiority of each dose of CP-690,550 to placebo.||43.13|23.04|<0.0001
72522867|NCT00814307|144575748|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.38|||<|0.0001|TWO_SIDED|95.0|-0.5|-0.27||A step-down procedure was used to control for multiple comparisons. For comparison of 10 mg to placebo to be statistically significant in this measure, comparison of 10 mg to placebo in ACR20 had to be significant.|Linear mixed effect model|||p-value was calculated using linear mixed effect model. The fixed effects of treatment, visit, and treatment-by-visit interaction were included, along with participant as random effect.||-0.27|-0.50|<.0001
72522868|NCT00814307|144575748|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.31|||<|0.0001|TWO_SIDED|95.0|-0.43|-0.2||A step-down procedure was used to control for multiple comparisons. For comparison of 5 mg to placebo to be statistically significant, comparison of 10 mg to placebo and comparison of 5 mg to placebo in ACR20 had to be statistically significant.|Linear mixed effect model|||p-value was calculated using linear mixed effect model. The fixed effects of treatment, visit, and treatment-by-visit interaction were included, along with participant as random effect.||-0.20|-0.43|<0.0001
72522869|NCT00814307|144575749|SUPERIORITY_OR_OTHER||Percent difference|5.24||||0.0728|TWO_SIDED|95.0|-0.49|10.96||A step-down procedure was used to control for multiple comparisons. For comparison of 10 mg to placebo to be statistically significant in this measure, comparison of 10 mg to placebo in HAQ-DI had to be significant.|Normal Approximation|||Normal approximation for the difference in binomial proportions was used to test the superiority of each dose of CP-690550 to placebo.||10.96|-0.49|0.0728
72570417|NCT02504671|144670137|OTHER||Difference|10.8|||||TWO_SIDED|95.0|0.8|20.8|||||Boolean based ACR/EULAR, Week 52. Difference to Placebo for Week 52 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||20.8|0.8|
72570418|NCT02504671|144670137|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||Boolean based ACR/EULAR, Week 52. Difference to Placebo for Week 52 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
72406231|NCT01896895|144321168|SUPERIORITY||LS mean difference|-0.5|||=|0.1452|TWO_SIDED|95.0|-1.1|0.2|||ANCOVA|||The difference in change of JRS severity subscore between treatment groups was analyzed by an ANCOVA according to a hierarchical test procedure. Second step of hierarchy is hypothesis of superiority of 25 unit dose group NT 201 compared to placebo. This was tested confirmatory (α=0.05, 2-sided) by an ANCOVA with treatment group, pooled site, and gender as fixed factors and baseline JRS severity subscore and age as covariates based on LS means comparison. Missing values were imputed by LOCF.||0.2|-1.1|=0.1452
72570419|NCT02504671|144670137|OTHER||Difference|8.1|||||TWO_SIDED|95.0|-0.7|16.9|||||Boolean based ACR/EULAR, Week 62 (follow-up). Difference to Placebo for Week 62 (follow-up) is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||16.9|-0.7|
72522870|NCT00814307|144575749|SUPERIORITY_OR_OTHER||Percent difference|1.31||||0.6193|TWO_SIDED|95.0|-3.85|6.46||A step-down procedure was used to control for multiple comparisons. For comparison of 5 mg to placebo to be statistically significant, comparison of 10 mg to placebo and comparison of 5 mg to placebo in HAQ-DI had to be statistically significant.|Normal Approximation|||Normal approximation for the difference in binomial proportions was used to test the superiority of each dose of CP-690550 to placebo.||6.46|-3.85|0.6193
72570420|NCT02504671|144670137|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||Boolean based ACR/EULAR, Week 62 (follow-up). Difference to Placebo for Week 62 (follow-up) is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
72570421|NCT02504671|144670137|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||Boolean based ACR/EULAR, Week 2. Difference to Placebo for Week 2 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
72570422|NCT02504671|144670137|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||Boolean based ACR/EULAR, Week 6. Difference to Placebo for Week 6 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
72570423|NCT02504671|144670137|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||Boolean based ACR/EULAR, Week 6. Difference to Placebo for Week 6 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
72570424|NCT02504671|144670137|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||Boolean based ACR/EULAR, Week 8. Difference to Placebo for Week 8 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
72570425|NCT02504671|144670137|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||Boolean based ACR/EULAR, Week 8. Difference to Placebo for Week 8 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
72570426|NCT02504671|144670137|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||Boolean based ACR/EULAR, Week 12. Difference to Placebo for Week 12 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
72570427|NCT02504671|144670137|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||Boolean based ACR/EULAR, Week 16. Difference to Placebo for Week 16 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
72570428|NCT02504671|144670137|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||Boolean based ACR/EULAR, Week 16. Difference to Placebo for Week 16 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
72406232|NCT00293384|144321171|SUPERIORITY_OR_OTHER||proportion|0.57||||0.1|TWO_SIDED|||||85% statistical power|Simon optimal design|||Optimal Simon design for phase II study. p0=45% p1=65%.||||0.10
72570429|NCT02504671|144670137|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||Boolean based ACR/EULAR, Week 20. Difference to Placebo for Week 20 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
72570430|NCT02504671|144670137|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||Boolean based ACR/EULAR, Week 20. Difference to Placebo for Week 20 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
72570431|NCT02504671|144670137|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||Boolean based ACR/EULAR, Week 24. Difference to Placebo for Week 24 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
72570432|NCT02504671|144670137|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||Boolean based ACR/EULAR, Week 24. Difference to Placebo for Week 24 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
72570433|NCT02504671|144670137|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||Boolean based ACR/EULAR, Week 28. Difference to Placebo for Week 28 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
72570434|NCT02504671|144670137|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||Boolean based ACR/EULAR, Week 28. Difference to Placebo for Week 28 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
72570435|NCT02504671|144670137|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||Boolean based ACR/EULAR, Week 32. Difference to Placebo for Week 32 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
72570436|NCT02504671|144670137|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||Boolean based ACR/EULAR, Week 32. Difference to Placebo for Week 32 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
72570437|NCT02504671|144670137|OTHER||Difference|8.1|||||TWO_SIDED|95.0|-0.7|16.9|||||Boolean based ACR/EULAR, Week 36. Difference to Placebo for Week 36 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||16.9|-0.7|
72570438|NCT02504671|144670137|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||Boolean based ACR/EULAR, Week 36. Difference to Placebo for Week 36 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
72570439|NCT02504671|144670137|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||Boolean based ACR/EULAR, Week 40. Difference to Placebo for Week 40 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
72570440|NCT02504671|144670137|OTHER||Difference|8.1|||||TWO_SIDED|95.0|-0.7|16.9|||||Boolean based ACR/EULAR, Week 40. Difference to Placebo for Week 40 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||16.9|-0.7|
72570441|NCT02504671|144670137|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||Boolean based ACR/EULAR, Week 44. Difference to Placebo for Week 44 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
72570442|NCT02504671|144670137|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||Boolean based ACR/EULAR, Week 44. Difference to Placebo for Week 44 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
72570443|NCT02504671|144670137|OTHER||Difference|10.8|||||TWO_SIDED|95.0|0.8|20.8|||||Boolean based ACR/EULAR, Week 48. Difference to Placebo for Week 48 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||20.8|0.8|
72570444|NCT02504671|144670137|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||Boolean based ACR/EULAR, Week 48. Difference to Placebo for Week 48 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
72406233|NCT00293384|144321172|SUPERIORITY_OR_OTHER||proportion|0.63||||||||||||||||||
72406234|NCT00293384|144321174|SUPERIORITY_OR_OTHER||proportion|0.06|||||TWO_SIDED|||||||||||||
72406235|NCT04300296|144321271|OTHER||Posterior median difference|-13.9|||||TWO_SIDED|95.0|-44.8|19.3|||||Bayesian model to obtain the posterior distribution of the treatment difference between AIN457 and placebo|||19.3|-44.8|
72570445|NCT02504671|144670137|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||Boolean based ACR/EULAR, Week 52. Difference to Placebo for Week 52 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
72406236|NCT04300296|144321271|OTHER||Posterior median difference|14.1|||||TWO_SIDED|95.0|-17.0|40.7|||||Bayesian model to obtain the posterior distribution of the treatment difference between AIN457 and placebo|||40.7|-17.0|
72570446|NCT02504671|144670137|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||Boolean based ACR/EULAR, Week 52. Difference to Placebo for Week 52 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
72570447|NCT02504671|144670137|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||Boolean based ACR/EULAR, Week 62 (follow-up). Difference to Placebo for Week 62 (follow-up) is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
72570448|NCT02504671|144670137|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||Boolean based ACR/EULAR, Week 62 (follow-up). Difference to Placebo for Week 62 (follow-up) is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
72570449|NCT02504671|144670138|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||CDAI, Week 4, Difference to Placebo for Week 4 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
72570450|NCT02504671|144670138|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||CDAI, Week 6. Difference to Placebo for Week 6 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
72570451|NCT02504671|144670138|OTHER||Difference|-2.7|||||TWO_SIDED|95.0|-7.9|2.5|||||CDAI, Week 8. Difference to Placebo for Week 8 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||2.5|-7.9|
72570452|NCT02504671|144670138|OTHER||Difference|-2.7|||||TWO_SIDED|95.0|-7.9|2.5|||||CDAI, Week 8. Difference to Placebo for Week 8 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||2.5|-7.9|
72570453|NCT02504671|144670138|OTHER||Difference|0.0|||||TWO_SIDED|95.0|-7.4|7.4|||||CDAI, Week 8. Difference to Placebo for Week 8 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.4|-7.4|
72570454|NCT02504671|144670138|OTHER||Difference|-2.7|||||TWO_SIDED|95.0|-7.9|2.5|||||CDAI, Week 12. Difference to Placebo for Week 12 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||2.5|-7.9|
72570455|NCT02504671|144670138|OTHER||Difference|-2.7|||||TWO_SIDED|95.0|-7.9|2.5|||||CDAI, Week 12. Difference to Placebo for Week 12 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||2.5|-7.9|
72570456|NCT02504671|144670138|OTHER||Difference|8.1|||||TWO_SIDED|95.0|-3.2|19.4|||||CDAI, Week 12. Difference to Placebo for Week 12 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||19.4|-3.2|
72570457|NCT02504671|144670138|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||CDAI, Week 16. Difference to Placebo for Week 16 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
72570458|NCT02504671|144670138|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||CDAI, Week 16. Difference to Placebo for Week 16 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
72570459|NCT02504671|144670138|OTHER||Difference|16.2|||||TWO_SIDED|95.0|4.3|28.1|||||CDAI, Week 16. Difference to Placebo for Week 16 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||28.1|4.3|
72570460|NCT02504671|144670138|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||CDAI, Week 20. Difference to Placebo for Week 20 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
72570461|NCT02504671|144670138|OTHER||Difference|10.8|||||TWO_SIDED|95.0|0.8|20.8|||||CDAI, Week 20. Difference to Placebo for Week 20 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||20.8|0.8|
72570462|NCT02504671|144670138|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||CDAI, Week 24. Difference to Placebo for Week 24 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
72570463|NCT02504671|144670138|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||CDAI, Week 24. Difference to Placebo for Week 24 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
72406237|NCT04300296|144321271|OTHER||Posterior median difference|6.5|||||TWO_SIDED|95.0|-25.4|35.4|||||Bayesian model to obtain the posterior distribution of the treatment difference between AIN457 and placebo|||35.4|-25.4|
72406238|NCT01633944|144321296|SUPERIORITY_OR_OTHER||Median Difference (Net)|-0.67||||0.0012|TWO_SIDED|95.0|-1.07|-0.26|||ANCOVA|||||-0.26|-1.07|0.0012
72570464|NCT02504671|144670138|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||CDAI, Week 28. Difference to Placebo for Week 28 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
72570465|NCT02504671|144670138|OTHER||Difference|10.8|||||TWO_SIDED|95.0|0.8|20.8|||||CDAI, Week 28. Difference to Placebo for Week 28 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||20.8|0.8|
72570466|NCT02504671|144670138|OTHER||Difference|13.5|||||TWO_SIDED|95.0|2.5|24.5|||||CDAI, Week 32. Difference to Placebo for Week 32 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||24.5|2.5|
72570467|NCT02504671|144670138|OTHER||Difference|8.1|||||TWO_SIDED|95.0|-0.7|16.9|||||CDAI, Week 32. Difference to Placebo for Week 32 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||16.9|-0.7|
72570468|NCT02504671|144670138|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||CDAI, Week 36. Difference to Placebo for Week 36 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
72570469|NCT02504671|144670138|OTHER||Difference|10.8|||||TWO_SIDED|95.0|0.8|20.8|||||CDAI, Week 36. Difference to Placebo for Week 36 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||20.8|0.8|
72570470|NCT02504671|144670138|OTHER||Difference|8.1|||||TWO_SIDED|95.0|-0.7|16.9|||||CDAI, Week 36. Difference to Placebo for Week 36 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||16.9|-0.7|
72522871|NCT01256918|144575793|SUPERIORITY_OR_OTHER||incidence|0.0|||>|0.05|||||||incidence|||"Any occurence of posterior capsular rupture in attempted vertical chop would have been an indicator of overzealous penetration as the vertical chop even though effective would not have been safe.~We hypothesised that use of callibrated phacotip after careful preoperative assessment for performing vertical chop during phacoemulsification is not associated with any posterior capsular rupture we noted any incidence of posterior capsular rupture."||||>0.05
72522872|NCT01256918|144575794|SUPERIORITY_OR_OTHER||pearson correlation coefficient|0.850958|||<|0.05|||||||pearson correlation coefficient|||null hypothesis : there is no correlation between nuclear colour and phacodepth required for a full thickness crack during a vertical chop||||<0.05
72522873|NCT01256918|144575795|SUPERIORITY_OR_OTHER||pearson correlation coefficient|0.842617|||<|0.05|||||||pearson correlation coefficient|||"Null hypothesis:~there is no correlation between nuclear opalescence and phacodepth required to achieve full thickness nuclear crack using a callibrated phacotip."||||<0.05
72522874|NCT01256918|144575796|SUPERIORITY_OR_OTHER||pearson correlation coefficient|0.111166|||>|0.05|||||||pearson correlation coefficient|||null hypothesis there is no correlation between lens thickness and penetration of phacotip (phacodepth)required to achieve full thickness crack in vertical chop during phacoemulsification||||>0.05
72522875|NCT01594749|144575808|SUPERIORITY_OR_OTHER||||||<|0.001||||||P-value based on Cochran-Mantel-Haenszel (CMH) method with stratification of gender|Cochran-Mantel-Haenszel|||Percentage difference in Fosaprepitant Regimen vs. Control Regimen||||<0.001
72522876|NCT01594749|144575809|SUPERIORITY_OR_OTHER||Difference in percentage vs. Control|0.6||||0.085|TWO_SIDED|95.0|-0.2|1.7||P-value based on Miettinen \& Nurminen method|Miettinen & Nurminen method|||||1.7|-0.2|0.085
72522877|NCT01594749|144575811|SUPERIORITY_OR_OTHER||||||<|0.001||||||P-value based on CMH method with stratification of gender|Cochran-Mantel-Haenszel|||Percentage difference in Fosaprepitant Regimen vs. Control Regimen||||<0.001
72522878|NCT01594749|144575812|SUPERIORITY_OR_OTHER|||||||0.184||||||P-value based on CMH method with stratification of gender|Cochran-Mantel-Haenszel|||Percentage difference in Fosaprepitant Regimen vs. Control Regimen||||0.184
72625068|NCT02908178|144779746|OTHER||Hazard Ratio (HR)|0.98||||0.113|TWO_SIDED|99.0|0.87|1.1||P-value is unadjusted. Threshold for statistical significance is 0.01.|Chi-squared||Reference is no SLNB. Estimates are from matched cohort and adjusted for physician visits, any hospitalization in the 3-24 months prior to DCIS diagnosis, use of preoperative breast MRI, surgeon's operation volume, and receipt of radiation therapy.|Testing the association between use of sentinel lymph node biopsy (SLNB) and any infection in the Aim 2 matched cohort.||1.10|0.87|0.113
72406239|NCT01633944|144321297|SUPERIORITY_OR_OTHER|||||||0.0012|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by stratum (dose level)||Responders with ≥30% pain reduction||||0.0012
72522879|NCT01594749|144575813|SUPERIORITY_OR_OTHER||||||<|0.001||||||P-value based on CMH method with stratification of gender|Cochran-Mantel-Haenszel|||Percentage difference in Fosaprepitant Regimen vs. Control Regimen||||<0.001
72522880|NCT02177786|144575814|SUPERIORITY||Least Square Means Difference|0.38|STANDARD_ERROR_OF_MEAN|1.21||0.755|TWO_SIDED|95.0|-2.0|2.75||Data was calculated using a mixed-effect model repeated measures (MMRM) model including terms for treatment group, baseline eGFR, visit and treatment by visit interaction for comparison of change from baseline in eGFR between selonsertib and placebo.|MMRM|||||2.75|-2.00|0.755
72522881|NCT02177786|144575814|SUPERIORITY||Least Square Means Difference|0.84|STANDARD_ERROR_OF_MEAN|1.22||0.492|TWO_SIDED|95.0|-1.55|3.23||Data was calculated using a MMRM model including terms for treatment group, baseline eGFR, visit and treatment by visit interaction for comparison of change from baseline in eGFR between selonsertib and placebo.|MMRM|||||3.23|-1.55|0.492
72522882|NCT02177786|144575814|SUPERIORITY||Least Square Means Difference|-0.87|STANDARD_ERROR_OF_MEAN|1.23||0.481|TWO_SIDED|95.0|-3.29|1.56||Data was calculated using a MMRM model including terms for treatment group, baseline eGFR, visit and treatment by visit interaction for comparison of change from baseline in eGFR between selonsertib and placebo.|MMRM|||||1.56|-3.29|0.481
72406240|NCT01633944|144321297|SUPERIORITY_OR_OTHER|||||||0.0754|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by stratum (dose level)||Responders with ≥50% pain reduction||||0.0754
72522883|NCT02177786|144575815|SUPERIORITY||Difference in Percentages|-2.2||||0.798|TWO_SIDED|95.0|-16.1|11.7|||Cochran-Mantel-Haenszel|P-value was based on a Cochran-Mantel-Haenszel (CMH) test stratified by stage of disease to compare the response rate between selonsertib and placebo.|The 95% confidence interval (CI) in the difference in percentages between selonsertib and placebo was based on Wald Asymptotic test.|||11.7|-16.1|0.798
72522884|NCT02177786|144575815|SUPERIORITY||Difference in Percentages|-9.2||||0.175|TWO_SIDED|95.0|-22.3|4.0|||Cochran-Mantel-Haenszel|P-value was based on a CMH test stratified by stage of disease to compare the response rate between selonsertib and placebo.|The 95% CI in the difference in percentages between selonsertib and placebo was based on Wald Asymptotic test.|||4.0|-22.3|0.175
72522885|NCT02177786|144575815|SUPERIORITY||Difference in Percentages|-2.9||||0.686|TWO_SIDED|95.0|-16.6|10.9|||Cochran-Mantel-Haenszel|P-value was based on a CMH test stratified by stage of disease to compare the response rate between selonsertib and placebo.|The 95% CI in the difference in percentages between selonsertib and placebo was based on Wald Asymptotic test.|||10.9|-16.6|0.686
72522886|NCT00439309|144575816|NON_INFERIORITY_OR_EQUIVALENCE|The sealing success rates for the investigational group and control groups were assumed to be 0.85 (85%) and 0.75 (75%), respectively, and the non-inferiority margin (10%) is 0.10. For safety reasons it was desired to have at least 100 Vascular Sealant treated subjects. It was determined that a sample size of at least 31 evaluable subjects is required for the control group. For blocking purposes, the number of evaluable control group subjects was set to 33, for a 3:1 randomization.||||||0.072|||||||Z-Test|one-sided Z-test based on the normal approximation to the binomial distribution testing||The effectiveness analyses were performed on the ITT population.||||0.072
72522887|NCT00439309|144575817|SUPERIORITY_OR_OTHER|||||||0.006|||||||t-test, 2 sided|p-value for superiority of the Vascular Sealant System compared to the GELFOAM Treatment from two-sided test based on the GEE regression model.||||||0.006
72522888|NCT00439309|144575818|SUPERIORITY_OR_OTHER|||||||0.654|||||||t-test, 2 sided|p-value for superiority of the Vascular Sealant System compared to the GELFOAMTreatment from two-sided test based on the GEE regression model||||||0.654
72522889|NCT00439309|144575819|SUPERIORITY_OR_OTHER|||||||0.089|||||||t-test, 2 sided|||||||0.089
72522890|NCT00439309|144575820|SUPERIORITY_OR_OTHER|||||||0.404|||||||Log Rank|Kaplan-Meier method was used to obtain estimated median times to wound closure and the corresponding 95% confidence intervals for each treatment group||||||0.404
72522891|NCT02473289|144575953|SUPERIORITY||Difference of Least Square (LS) Means|-0.8|STANDARD_ERROR_OF_MEAN|1.67||0.31|TWO_SIDED|75.0|-2.77|1.1||1-sided|MMRM|Here 'MMRM' refers to Mixed-effect Model Using Repeated Measures.||||1.10|-2.77|0.310
72522892|NCT03285490|144575975|SUPERIORITY||||||<|0.0001||||||P-value threshold for statistical significance was 0.5%|Cochran-Mantel-Haenszel|||Statistical significance in the study for Day 57 complete clearance rate was analyzed using a Cochran-Mantel-Haenszel model controlling for treatment location (face or scalp) and treatment group (Placebo versus KX2-391 Ointment 1%).||||<0.0001
72522893|NCT03285490|144575976|SUPERIORITY||||||<|0.0001||||||P-value threshold for statistical significance was 0.5%.|Cochran-Mantel-Haenszel|||Statistical significance in the study for Day 57 partial clearance rate was analyzed using a Cochran-Mantel-Haenszel model controlling for treatment location (face or scalp) and treatment group (Placebo versus KX2-391 Ointment 1%).||||<0.0001
72522894|NCT01291511|144575996|SUPERIORITY||Cox Proportional Hazard|5.2|||<|0.0001|TWO_SIDED|95.0|3.2|8.4|||Log Rank|||||8.4|3.2|<0.0001
72522895|NCT01291511|144575997|SUPERIORITY||||||<|0.0001||||||P-value is based on an ANCOVA model with treatment and site as main effects and DBRP baseline as a covariate.|ANCOVA|||||||<0.0001
72522896|NCT01291511|144575999|SUPERIORITY|||||||0.0062||||||P-value is based on an ANCOVA model with treatment and site as main effects and DBRP baseline as a covariate.|ANCOVA|||||||0.0062
72522897|NCT00047008|144576004|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.9||||0.18|TWO_SIDED|95.0|0.719|1.128|||Log Rank|||A sample size of 684 analyzable patients provides 80% power to detect a relative reduction of 25% in the rate of death in the accelerated-fractionation radiotherapy group as compared with the standard-fractionation radiotherapy group, assuming a 2-year rate of overall survival of 45% in the standard-fractionation radiotherapy group, with the use of a one-sided log-rank test at the 0.05 significance level.||1.128|0.719|0.180
72522898|NCT00047008|144576005|SUPERIORITY||Hazard Ratio (HR)|1.09||||0.76|TWO_SIDED|95.0|0.83|1.43||One-sided significance level = 0.05|Gray's test|||||1.43|0.83|0.76
72522899|NCT00047008|144576006|SUPERIORITY||Hazard Ratio (HR)|1.11||||0.8|TWO_SIDED|95.0|0.85|1.44||One-sided significance level = 0.05|Gray's test|||||1.44|0.85|0.80
72522900|NCT00047008|144576007|SUPERIORITY||Hazard Ratio (HR)|0.99||||0.42|TWO_SIDED|95.0|0.81|1.2||One-sided significance level = 0.05|Log Rank|||||1.20|0.81|0.42
72522901|NCT00047008|144576008|SUPERIORITY||Hazard Ratio (HR)|1.0||||0.5|TWO_SIDED|95.0|0.81|1.23||One-sided significance level = 0.05|Log Rank|||||1.23|0.81|0.50
72570471|NCT02504671|144670138|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||CDAI, Week 40. Difference to Placebo for Week 40 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
72522902|NCT00047008|144576009|SUPERIORITY|||||||0.21||||||Two-side significance level = 0.05|Fisher Exact|||Acute toxicity||||0.21
72522903|NCT00047008|144576009|SUPERIORITY|||||||0.18||||||Two-sided significance level = 0.05|Fisher Exact|||Late toxicity||||0.18
72522904|NCT00047008|144576010|SUPERIORITY|||||||0.92||||||Two-sided significance level = 0.05|t-test, 2 sided|||Two hundred and fifty-two patients (126/arm) provide at least 86% power to detect a difference of 7 (standard deviation 18) between arms with a two-sided significance level of 0.05.||||0.92
72522905|NCT00047008|144576011|SUPERIORITY|||||||0.67||||||Two-sided significance level = 0.05|t-test, 2 sided|||Two hundred and fifty-two patients (126/arm) provide at least 86% power to detect a difference of 7 (standard deviation 18) between arms with a two-sided significance level of 0.05.||||0.67
72522906|NCT00047008|144576012|SUPERIORITY|||||||0.43||||||Two-sided significance level = 0.05|t-test, 2 sided|||Two hundred and fifty-two patients (126/arm) provide at least 86% power to detect a difference of 7 (standard deviation 18) between arms with a two-sided significance level of 0.05.||||0.43
72522907|NCT00047008|144576013|SUPERIORITY|||||||0.39||||||Two-sided significance level = 0.05|t-test, 2 sided|||Two hundred and fifty-two patients (126/arm) provide at least 86% power to detect a difference of 7 (standard deviation 18) between arms with a two-sided significance level of 0.05.||||0.39
72522908|NCT01047436|144576023|SUPERIORITY_OR_OTHER||difference between treatments|26.7||||0.17|TWO_SIDED|95.0|-0.3|53.7|||Fisher Exact|||The sample size was not statistically determined in this initial trial with ArTimist. For the primary outcome analysis, the percentage of patients defined as having success were determined. The difference between ArTiMist and quinine, along with its 95% confidence interval (CI) were determined. The difference between treatments were compared using Fisher's Exact test||53.7|-0.3|0.17
72522909|NCT01047436|144576025|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.05||||0.7|TWO_SIDED|95.0|0.48|3.01|||Log Rank|||The time for the parasite count to fall by 90% (PCT90) was determined for each patient as the time in minutes/seconds, when the parasite count fell by 90% The PCT90 was appropriately summarised for each treatment for the FAS . The times were presented graphically for each endpoint using a life-table curve (Kaplan-Meier method). For each endpoint the survival curves were compared by the log-rank test. The hazard ratio was calculated along with its 95% CI.||3.01|0.48|0.70
72522910|NCT01047436|144576027|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.92||||0.76||95.0|0.34|2.18||Difference between survival curves compared by Log Rank test|Log Rank|||The PCT50 was determined for each patient as the time in minutes/seconds, when the parasite count fell by 50% The PCT50 was appropriately summarised for each treatment for the FAS . The times were presented graphically for each endpoint using a life-table curve (Kaplan-Meier method). For each endpoint the survival curves were compared by the log-rank test. The hazard ratio was calculated along with its 95% CI.||2.18|0.34|0.76
72570472|NCT02504671|144670138|OTHER||Difference|10.8|||||TWO_SIDED|95.0|0.8|20.8|||||CDAI, Week 40. Difference to Placebo for Week 40 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||20.8|0.8|
72570473|NCT02504671|144670138|OTHER||Difference|8.1|||||TWO_SIDED|95.0|-0.7|16.9|||||CDAI, Week 40. Difference to Placebo for Week 40 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||16.9|-0.7|
72570474|NCT02504671|144670138|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||CDAI, Week 44. Difference to Placebo for Week 44 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
72570475|NCT02504671|144670138|OTHER||Difference|10.8|||||TWO_SIDED|95.0|0.8|20.8|||||CDAI, Week 44. Difference to Placebo for Week 44 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||20.8|0.8|
72570476|NCT02504671|144670138|OTHER||Difference|10.8|||||TWO_SIDED|95.0|0.8|20.8|||||CDAI, Week 44. Difference to Placebo for Week 44 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||20.8|0.8|
72570477|NCT02504671|144670138|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||CDAI, Week 48. Difference to Placebo for Week 48 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
72570478|NCT02504671|144670138|OTHER||Difference|13.5|||||TWO_SIDED|95.0|2.5|24.5|||||CDAI, Week 48. Difference to Placebo for Week 48 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||24.5|2.5|
72522911|NCT00424099|144576030|OTHER|||||||0.16|||||||Kruskal-Wallis|||||||0.16
72522912|NCT00424099|144576031|OTHER|||||||0.45|||||||Kruskal-Wallis|||||||0.45
72522913|NCT00796003|144576032|SUPERIORITY_OR_OTHER||Overall Response Rate|26.5|STANDARD_ERROR_OF_MEAN|7.6|<|0.0001|TWO_SIDED|90.0|14.6|41.6|||Binomial test|one-tailed 5% level at a significance level||Null Hypothesis: Overall Remission Rate = 5%||41.6|14.6|<0.0001
72522914|NCT02437162|144576043|SUPERIORITY||Percentage difference|2.586||||0.669|TWO_SIDED|95.0|-9.138|14.31|||Cochran-Mantel-Haenszel|||||14.310|-9.138|0.669
72522915|NCT02437162|144576043|SUPERIORITY||Percentage difference|-0.646||||0.913|TWO_SIDED|95.0|-12.18|10.887|||Cochran-Mantel-Haenszel|||||10.887|-12.180|0.913
72570479|NCT02504671|144670138|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||CDAI, Week 48. Difference to Placebo for Week 48 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
72369333|NCT00611026|144248572|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.3|STANDARD_ERROR_OF_MEAN|1.1||0.0429|TWO_SIDED|95.0|0.1|4.6|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.|Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.|Treatment Difference Tolterodine ER vs Placebo: HRQL scale score total.||4.6|0.1|0.0429
72522916|NCT04338321|144576086|SUPERIORITY||Mean Difference (Final Values)|9.44|||=|0.003|TWO_SIDED|95.0|3.19|15.68|||Cochran-Mantel-Haenszel|||||15.68|3.19|=0.003
72522917|NCT03107793|144576111|SUPERIORITY||||||=|0.0871|||||||Cochran-Mantel-Haenszel|||||||= 0.0871
72522918|NCT02808507|144576135|OTHER||Treatment initiation ratio|1.04||||0.73|TWO_SIDED|95.0|0.8|1.3|||See above comments|||The primary analysis was based on the facility-level rate ratio. We first calculated an unadjusted ratio of the treatment initiation rates between the two arms and the corresponding 95% CI. We first fit a Poisson regression to the facility-level counts and the district and historical volume covariates. The residuals ratios, calculated as the ratio of the observed over the expected counts, were then used in the second stage to estimate the between-arm rate ratio and the corresponding 95% CI.||1.3|0.80|0.73
72522919|NCT02808507|144576136|OTHER||Treatment initiation ratio|1.05||||0.68|TWO_SIDED|95.0|0.97|1.13|||Poisson regression||Adjusted for district, study phase and clinic random effect.|The primary outcome of the study was the comparative number of people with incident TB diagnosed and started on treatment at study clinics during the two study periods, excluding the six-month washout period. The number of people starting treatment for incident TB was calculated by performing a review of paper and electronic medical records at each clinic on a quarterly basis during the study.||1.13|0.97|0.68
72522920|NCT02808507|144576137|OTHER||Prevalence ratio|1.0||||0.8|TWO_SIDED|95.0|0.51|1.95||"The pre-specified secondary study outcome was the number of Xpert-based TB diagnoses made among enrolled contacts (secondary cases) by arm."|Poisson regression||Adjusted for study phase and district|||1.95|0.51|0.80
72570480|NCT02504671|144670138|OTHER||Difference|13.5|||||TWO_SIDED|95.0|2.5|24.5|||||CDAI, Week 52. Difference to Placebo for Week 52 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||24.5|2.5|
72570481|NCT02504671|144670138|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||CDAI, Week 52. Difference to Placebo for Week 52 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
72570482|NCT02504671|144670138|OTHER||Difference|8.1|||||TWO_SIDED|95.0|-0.7|16.9|||||CDAI, Week 62 (follow-up). Difference to Placebo for Week 62 (follow-up) is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||16.9|-0.7|
72570483|NCT02504671|144670138|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||CDAI, Week 62 (follow-up). Difference to Placebo for Week 62 (follow-up) is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
72570484|NCT02504671|144670138|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||CDAI, Week 2. Difference to Placebo for Week 2 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
72570485|NCT02504671|144670138|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||CDAI, Week 4. Difference to Placebo for Week 4 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.6|||7.9|-2.5|
72570486|NCT02504671|144670138|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||CDAI, Week 6. Difference to Placebo for Week 6 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
72570487|NCT02504671|144670138|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||CDAI, Week 6. Difference to Placebo for Week 6 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
72570488|NCT02504671|144670138|OTHER||Difference|0.0|||||TWO_SIDED|95.0|-7.4|7.4|||||CDAI, Week 8. Difference to Placebo for Week 8 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.4|-7.4|
72570489|NCT02504671|144670138|OTHER||Difference|0.0|||||TWO_SIDED|95.0|-7.4|7.4|||||CDAI, Week 8. Difference to Placebo for Week 8 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.4|-7.4|
72522921|NCT01989572|144576142|SUPERIORITY_OR_OTHER_LEGACY|||||||0.528|||||||Log Rank|stratifying on HLA-A2 status, site of metastases and number of metastatic lesions.||||||0.528
72570490|NCT02504671|144670138|OTHER||Difference|0.0|||||TWO_SIDED|95.0|-7.4|7.4|||||CDAI, Week 12. Difference to Placebo for Week 12 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.4|-7.4|
72570491|NCT02504671|144670138|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-6.3|11.7|||||CDAI, Week 12. Difference to Placebo for Week 12 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||11.7|-6.3|
72570492|NCT02504671|144670138|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||CDAI, Week 16. Difference to Placebo for Week 16 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
72570493|NCT02504671|144670138|OTHER||5.4|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||CDAI, Week 16. Difference to Placebo for Week 16 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
72570494|NCT02504671|144670138|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||CDAI, Week 20. Difference to Placebo for Week 20 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
72570495|NCT02504671|144670138|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||CDAI, Week 20. Difference to Placebo for Week 20 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
72570496|NCT02504671|144670138|OTHER||Difference|8.1|||||TWO_SIDED|95.0|-0.7|16.9|||||CDAI, Week 24. Difference to Placebo for Week 24 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||16.9|-0.7|
72570497|NCT02504671|144670138|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||CDAI, Week 24. Difference to Placebo for Week 24 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
72570498|NCT02504671|144670138|OTHER||Difference|13.5|||||TWO_SIDED|95.0|2.5|24.5|||||CDAI, Week 28. Difference to Placebo for Week 28 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||24.5|2.5|
72522922|NCT01989572|144576143|SUPERIORITY_OR_OTHER_LEGACY|||||||0.131|||||||Log Rank|stratifying on HLA-A2 status, site of metastases, and number of metastatic lesions||||||0.131
72570499|NCT02504671|144670138|OTHER||Difference|8.1|||||TWO_SIDED|95.0|-0.7|16.9|||||CDAI, Week 32. Difference to Placebo for Week 32 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||16.9|-0.7|
72570500|NCT02504671|144670138|OTHER||Difference|10.8|||||TWO_SIDED|95.0|0.8|20.8|||||CDAI, Week 32. Difference to Placebo for Week 32 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||20.8|0.8|
72570501|NCT02504671|144670138|OTHER||Difference|13.5|||||TWO_SIDED|95.0|2.5|24.5|||||CDAI, Week 36. Difference to Placebo for Week 36 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||24.5|2.5|
72570502|NCT02504671|144670138|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||CDAI, Week 36. Difference to Placebo for Week 36 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
72570503|NCT02504671|144670138|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||CDAI, Week 40. Difference to Placebo for Week 40 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
72522923|NCT01989572|144576144|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6|||||||Log Rank|stratifying on GM-CSF, site of metastases and number of metastatic lesions||||||0.60
72522924|NCT01989572|144576145|SUPERIORITY_OR_OTHER_LEGACY|||||||0.71||||||stratifying on GM-CSF, site of metastases and number of metastatic lesions|Log Rank|||||||0.71
72522925|NCT01989572|144576146|SUPERIORITY_OR_OTHER_LEGACY|||||||0.88|||||||Log Rank|stratifying on site of metastases and number of metastatic lesions||Treatment arm comparison in patients with positive HLA-A2 status||||0.88
72522926|NCT01989572|144576146|SUPERIORITY_OR_OTHER_LEGACY|||||||0.69|||||||Log Rank|stratifying on site of metastases and number of metastatic lesions||Treatment arm comparison in patients with negative HLA-A2 status||||0.69
72570504|NCT02504671|144670138|OTHER||Difference|13.5|||||TWO_SIDED|95.0|2.5|24.5|||||CDAI, Week 40. Difference to Placebo for Week 40 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||24.5|2.5|
72522927|NCT01989572|144576147|SUPERIORITY_OR_OTHER_LEGACY|||||||0.91|||||||Log Rank|stratifying on site of metastases and number of metastatic lesions||Treatment arm comparison in patients with positive HLA-A2 status||||0.91
72522928|NCT01989572|144576147|SUPERIORITY_OR_OTHER_LEGACY|||||||0.13|||||||Log Rank|stratifying on site of metastases and number of metastatic lesions||Treatment arm comparisons in patients with negative HLA-A2 status||||0.13
72522929|NCT02910089|144576148|SUPERIORITY|As per the SAP, no p-values were computed. Only point estimates with 95% confidence intervals were evaluated.|Mean Difference (Final Values)|0.06|||||TWO_SIDED|95.0|-0.2|0.32||As per the SAP, no p-values were computed. Only point estimates with 95% confidence intervals were evaluated.|GEE|Generalized Estimating Equations with an identity link function (as a continuous variable) and normally distributed errors|Model-based Mean Differences are reported that have been adjusted for imbalanced baseline characteristics|||0.32|-0.2|
72522930|NCT02910089|144576149|OTHER||Mean Difference (Final Values)|1.0|||||TWO_SIDED|95.0|-2.42|4.4||As per the SAP, no p-values were computed. Only point estimates with 95% confidence intervals were evaluated.|GEE|Generalized Estimating Equations with an identity link function and normally distributed errors|Model-based Mean Differences are reported that have been adjusted for imbalanced baseline characteristics|Average of the percentage (proportion x 100) of days covered across all subjects.||4.40|-2.42|
72522931|NCT02910089|144576150|SUPERIORITY||Odds Ratio (OR)|1.03|||||TWO_SIDED|95.0|0.83|1.28||As per the SAP, no p-values were computed. Only point estimates with 95% confidence intervals were evaluated.|GEE|Generalized Estimating Equations with a logit link and binary distributed errors||||1.28|0.83|
72570505|NCT02504671|144670138|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||CDAI, Week 44. Difference to Placebo for Week 44 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
72570506|NCT02504671|144670138|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||CDAI, Week 44. Difference to Placebo for Week 44 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
72406241|NCT00958776|144321353|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.03||||0.973|TWO_SIDED|95.0|0.69|1.55|||Wilcoxon-Gehan statistic|Analysis stratified by duration of illness at randomization, ICU status and use of supplemental oxygen at Baseline, influenza season and type.|The hazard ratio was calculated using a Cox regression model with factors of duration of illness at randomization, ICU status at Baseline, use of supplemental oxygen at Baseline, influenza season, and influenza type.|||1.55|0.69|0.973
72406242|NCT00958776|144321355|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.14||||0.558|TWO_SIDED|95.0|0.75|1.72|||Wilcoxon-Gehan statistic|Analysis stratified by duration of illness at randomization, ICU status and use of supplemental oxygen at Baseline, influenza season and type.|The hazard ratio was calculated using a Cox regression model with factors of duration of illness at randomization, ICU status at Baseline, use of supplemental oxygen at Baseline, influenza season, and influenza type.|||1.72|0.75|0.558
72406243|NCT00958776|144321356|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.88||||0.633|TWO_SIDED|95.0|0.59|1.31|||Wilcoxon-Gehan statistic|Analysis stratified by duration of illness at randomization, ICU status and use of supplemental oxygen at Baseline, influenza season and type.|The hazard ratio was calculated using a Cox regression model with factors of duration of illness at randomization, ICU status at Baseline, use of supplemental oxygen at Baseline, influenza season, and influenza type.|||1.31|0.59|0.633
72406244|NCT00958776|144321357|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.46||||0.747|TWO_SIDED|95.0|0.92|2.32|||Wilcoxon-Gehan statistic|Analysis stratified by duration of illness at randomization, ICU status and use of supplemental oxygen at Baseline, influenza season and type.|The hazard ratio was calculated using a Cox regression model with factors of duration of illness at randomization, ICU status at Baseline, use of supplemental oxygen at Baseline, influenza season, and influenza type.|||2.32|0.92|0.747
72406245|NCT00958776|144321359|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.1||||0.303|TWO_SIDED|95.0|0.41|2.98|||Wilcoxon-Gehan statistic|Analysis stratified by duration of illness at randomization, ICU status and use of supplemental oxygen at Baseline, influenza season and type.|The hazard ratio is calculated using a Cox regression model with factors of duration of illness at randomization, ICU status at baseline, use of supplemental oxygen at baseline, influenza season, and influenza type.|||2.98|0.41|0.303
72406246|NCT00958776|144321361|SUPERIORITY_OR_OTHER|||||||0.768|TWO_SIDED||||||Cochran-Mantel-Haenszel|Analysis stratified by symptom onset prior to randomization, Baseline ICU status, need for supplemental oxygen at Baseline, influenza season and type.||||||0.768
72406247|NCT00958776|144321362|SUPERIORITY_OR_OTHER|||||||0.758|TWO_SIDED||||||Cochran-Mantel-Haenszel|Analysis stratified by symptom onset prior to randomization, Baseline ICU status, need for supplemental oxygen at Baseline, influenza season and type.||||||0.758
72406248|NCT02583256|144321394|NON_INFERIORITY|Lower bound of two-sided 95% CI on the ratio of aQIV-aQIV/aQIV-QIV HI GMT should not fall below 0.667.|GMT ratio|1.19|||||TWO_SIDED|95.0|1.1|1.3||||||Comparison performed for strain A/H1N1.||1.3|1.1|
72406249|NCT02583256|144321394|NON_INFERIORITY|Lower bound of two-sided 95% CI on the ratio of aQIV-aQIV/aQIV-QIV HI GMT should not fall below 0.667.|GMT ratio|0.93|||||TWO_SIDED|95.0|0.9|1.0||||||Comparison performed for strain A/H3N2.||1.0|0.9|
72406250|NCT02583256|144321394|NON_INFERIORITY|Lower bound of two-sided 95% CI on the ratio of aQIV-aQIV/aQIV-QIV HI GMT should not fall below 0.667.|GMT ratio|1.19|||||TWO_SIDED|95.0|1.1|1.3||||||Comparison performed for strain B/Yamagata.||1.3|1.1|
72406251|NCT02583256|144321394|NON_INFERIORITY|Lower bound of two-sided 95% CI on the ratio of aQIV-aQIV/aQIV-QIV HI GMT should not fall below 0.667.|GMT ratio|1.18|||||TWO_SIDED|95.0|1.1|1.3||||||Comparison performed for strain B/Victoria.||1.3|1.1|
72406252|NCT02583256|144321395|SUPERIORITY|Superiority criterion for the GMT ratio: Lower bound of two-sided 95% CI on the ratio of aQIV-aQIV/aQIV-QIV HI GMT should exceed 1.|GMT ratio|1.19|||||TWO_SIDED|95.0|1.1|1.3||||||Comparison performed for strain A/H1N1.||1.3|1.1|
72570507|NCT02504671|144670138|OTHER||Difference|10.8|||||TWO_SIDED|95.0|0.8|20.8|||||CDAI, Week 48. Difference to Placebo for Week 48 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||20.8|0.8|
72570508|NCT02504671|144670138|OTHER||Difference|8.1|||||TWO_SIDED|95.0|-0.7|16.9|||||CDAI, Week 48. Difference to Placebo for Week 48 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||16.9|-0.7|
72570509|NCT02504671|144670138|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||CDAI, Week 52. Difference to Placebo for Week 52 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
72406253|NCT02583256|144321395|SUPERIORITY|Lower bound of two-sided 95% CI on the ratio of aQIV-aQIV/aQIV-QIV HI GMT should exceed 1.|GMT ratio|0.93|||||TWO_SIDED|95.0|0.9|1.0||||||Comparison performed for strain A/H3N2.||1.0|0.9|
72406254|NCT02583256|144321395|SUPERIORITY|Lower bound of two-sided 95% CI on the ratio of aQIV-aQIV/aQIV-QIV HI GMT should exceed 1.|GMT ratio|1.19|||||TWO_SIDED|95.0|1.1|1.3||||||Comparison performed for strain B/Yamagata.||1.3|1.1|
72406255|NCT02583256|144321395|SUPERIORITY|Lower bound of two-sided 95% CI on the ratio of aQIV-aQIV/aQIV-QIV HI GMT should exceed 1.|GMT ratio|1.19|||||TWO_SIDED|95.0|1.1|1.3||||||Comparison performed for strain B/Victoria.||1.3|1.1|
72406256|NCT02583256|144321396|NON_INFERIORITY|Lower bound of two-sided 95% CI on the ratio of QIV-aQIV/QIV-QIV HI GMT should not fall below 0.667.|GMT ratio|1.39|||||TWO_SIDED|95.0|1.28|1.51||||||Comparison performed for strain A/H1N1.||1.51|1.28|
72406257|NCT02583256|144321396|NON_INFERIORITY|Lower bound of two-sided 95% CI on the ratio of QIV-aQIV/QIV-QIV HI GMT should not fall below 0.667.|GMT ratio|1.06|||||TWO_SIDED|95.0|0.99|1.14||||||Comparison performed for strain A/H3N2||1.14|0.99|
72406258|NCT02583256|144321396|NON_INFERIORITY|Lower bound of two-sided 95% CI on the ratio of QIV-aQIV/QIV-QIV HI GMT should not fall below 0.667.|GMT ratio|1.42|||||TWO_SIDED|95.0|1.27|1.58||||||Comparison performed for strain B/Yamagata.||1.58|1.27|
72406259|NCT02583256|144321396|NON_INFERIORITY|Lower bound of two-sided 95% CI on the ratio of QIV-aQIV/QIV-QIV HI GMT should not fall below 0.667.|GMT ratio|1.36|||||TWO_SIDED|95.0|1.22|1.51||||||Comparison performed for strain B/Victoria.||1.51|1.22|
72406260|NCT02583256|144321397|NON_INFERIORITY|Lower bound of two-sided 95% CI on the ratio of aQIV-aQIV/aQIV-QIV HI GMT should not fall below 0.667.|GMT ratio|1.19|||||TWO_SIDED|95.0|1.07|1.32||||||Comparison performed for strain A/H1N1.||1.32|1.07|
72406261|NCT02583256|144321397|NON_INFERIORITY|Lower bound of two-sided 95% CI on the ratio of aQIV-aQIV/aQIV-QIV HI GMT should not fall below 0.667.|GMT ratio|0.99|||||TWO_SIDED|95.0|0.9|1.09||||||Comparison performed for strain A/H3N2.||1.09|0.90|
72406262|NCT02583256|144321397|NON_INFERIORITY|Lower bound of two-sided 95% CI on the ratio of aQIV-aQIV/aQIV-QIV HI GMT should not fall below 0.667.|GMT ratio|1.12|||||TWO_SIDED|95.0|1.01|1.25||||||Comparison performed for strain B/Yamagata.||1.25|1.01|
72406263|NCT02583256|144321397|NON_INFERIORITY|Lower bound of two-sided 95% CI on the ratio of aQIV-aQIV/aQIV-QIV HI GMT should not fall below 0.667.|GMT ratio|1.11|||||TWO_SIDED|95.0|0.98|1.27||||||Comparison performed for strain B/Victoria.||1.27|0.98|
72406264|NCT02583256|144321397|NON_INFERIORITY|Lower bound of two-sided 95% CI on the ratio of QIV-aQIV/QIV-QIV HI GMT should not fall below 0.667.|GMT ratio|1.4|||||TWO_SIDED|95.0|1.3|1.5||||||Comparison performed for strain A/H1N1.||1.5|1.3|
72406265|NCT02583256|144321397|NON_INFERIORITY|Lower bound of two-sided 95% CI on the ratio of QIV-aQIV/QIV-QIV HI GMT should not fall below 0.667.|GMT ratio|1.01|||||TWO_SIDED|95.0|0.9|1.1||||||Comparison performed for strain A/H3N2.||1.1|0.9|
72522932|NCT02910089|144576151|OTHER|As per the SAP, no p-values were computed. Only point estimates with 95% confidence intervals were evaluated.|Odds Ratio (OR)|0.91|||||TWO_SIDED|95.0|0.71|1.17||As per the SAP, no p-values were computed. Only point estimates with 95% confidence intervals were evaluated.|See comments|Generalized Estimating Equations with a logit link and binary distributed errors||||1.17|0.71|
72522933|NCT02280096|144576154|SUPERIORITY||t-boostrap|0.028||||0.028|TWO_SIDED||||||t-test, 1 sided|||||||0.028
72570510|NCT02504671|144670138|OTHER||Difference|8.1|||||TWO_SIDED|95.0|-0.7|16.9|||||CDAI, Week 52. Difference to Placebo for Week 52 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||16.9|-0.7|
72570511|NCT02504671|144670138|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||CDAI, Week 62 (follow-up). Difference to Placebo for Week 62 (follow-up) is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
72570512|NCT02504671|144670138|OTHER||Difference|16.2|||||TWO_SIDED|95.0|4.3|28.1|||||CDAI, Week 62 (follow-up). Difference to Placebo for Week 62 (follow-up) is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||28.1|4.3|
72570513|NCT02504671|144670138|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||Difference to Placebo for Week 28 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
72570514|NCT02504671|144670139|OTHER||Mean Difference (Net)|-4.09||||0.05|TWO_SIDED|95.0|-8.18|0.0||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 1, SDAI|||0.00|-8.18|0.050
72570515|NCT02504671|144670139|OTHER||Mean Difference (Net)|-3.66||||0.086|TWO_SIDED|95.0|-7.84|0.52||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 1,SDAI|||0.52|-7.84|0.086
72570516|NCT02504671|144670139|OTHER||Mean Difference (Net)|-4.33||||0.038|TWO_SIDED|95.0|-8.43|-0.23||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 1,SDAI|||-0.23|-8.43|0.038
72570517|NCT02504671|144670139|OTHER||Mean Difference (Net)|-4.06||||0.119|TWO_SIDED|95.0|-9.18|1.05||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 2,SDAI|||1.05|-9.18|0.119
72570518|NCT02504671|144670139|OTHER||Mean Difference (Net)|-4.72||||0.071|TWO_SIDED|95.0|-9.85|0.4||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 2,SDAI|||0.40|-9.85|0.071
72570519|NCT02504671|144670139|OTHER||Mean Difference (Net)|-5.48||||0.034|TWO_SIDED|95.0|-10.53|-0.42||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 2,SDAI|||-0.42|-10.53|0.034
72570520|NCT02504671|144670139|OTHER||Mean Difference (Net)|-6.78||||0.023|TWO_SIDED|95.0|-12.61|-0.94||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4,SDAI|||-0.94|-12.61|0.023
72406266|NCT02583256|144321397|NON_INFERIORITY|Lower bound of two-sided 95% CI on the ratio of QIV-aQIV/QIV-QIV HI GMT should not fall below 0.667.|GMT ratio|1.3|||||TWO_SIDED|95.0|1.2|1.4||||||Comparison performed for strain B/Yamagata.||1.4|1.2|
72406267|NCT02583256|144321397|NON_INFERIORITY|Lower bound of two-sided 95% CI on the ratio of QIV-aQIV/QIV-QIV HI GMT should not fall below 0.667.|GMT ratio|1.32|||||TWO_SIDED|95.0|1.2|1.5||||||Comparison performed for strain B/Victoria.||1.5|1.2|
72406268|NCT02583256|144321398|NON_INFERIORITY|The lower bound of two-sided 95% CI on the difference between SCR should not be below -10%.|SCR difference|1.8|||||TWO_SIDED|95.0|-4.9|8.6||||||Comparison performed for strain A/H1N1.||8.6|-4.9|
72570521|NCT02504671|144670139|OTHER||Mean Difference (Net)|-7.28||||0.014|TWO_SIDED|95.0|-13.09|-1.47||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4,SDAI|||-1.47|-13.09|0.014
72625069|NCT02908178|144779746|OTHER||Hazard Ratio (HR)|1.21||||0.01|TWO_SIDED|99.0|0.93|1.58||P-value is unadjusted. Threshold for statistical significance is 0.01.|Chi-squared||Reference is no SLNB. Estimates are from matched cohort and adjusted for physician visits, any hospitalization in the 3-24 months prior to DCIS diagnosis, use of preoperative breast MRI, surgeon's operation volume, and receipt of radiation therapy.|Testing the association between use of sentinel lymph node biopsy (SLNB) and seroma in the Aim 2 matched cohort.||1.58|0.93|0.010
72406269|NCT02583256|144321398|NON_INFERIORITY|The lower bound of two-sided 95% CI on the difference between SCR should not be below -10%.|SCR difference|0.9|||||TWO_SIDED|95.0|-5.6|7.3||||||Comparison performed for strain A/H3N2.||7.3|-5.6|
72406270|NCT02583256|144321398|NON_INFERIORITY|The lower bound of two-sided 95% CI on the difference between SCR should not be below -10%.|SCR difference|4.3|||||TWO_SIDED|95.0|-1.8|10.4||||||Comparison performed for strain B/Yamagata.||10.4|-1.8|
72406271|NCT02583256|144321398|NON_INFERIORITY|The lower bound of two-sided 95% CI on the difference between SCR should not be below -10%.|SCR difference|2.6|||||TWO_SIDED|95.0|-3.3|8.5||||||Comparison performed for strain B/Victoria.||8.5|-3.3|
72522934|NCT02280096|144576155|SUPERIORITY||t-boostrap|0.001||||0.001|ONE_SIDED||||||t-test, 1 sided|||||||0.001
72522935|NCT02280096|144576156|SUPERIORITY||t-boostrap|0.016||||0.016|TWO_SIDED||||||t-test, 1 sided|||||||0.016
72522936|NCT02280096|144576157|SUPERIORITY||t-boostrap|0.64||||0.64|ONE_SIDED||||||t-test, 1 sided|||Reading speed||||0.64
72522937|NCT02280096|144576157|SUPERIORITY||t-boostrap|0.43||||0.43|TWO_SIDED||||||t-test, 1 sided|||Count speed||||0.43
72406272|NCT02583256|144321398|NON_INFERIORITY|The lower bound of two-sided 95% CI on the difference between SCR should not be below -10%.|SCR difference|9.67|||||TWO_SIDED|95.0|3.11|16.17||||||Comparison performed for strain A/H1N1.||16.17|3.11|
72406273|NCT02583256|144321398|NON_INFERIORITY|The lower bound of two-sided 95% CI on the difference between SCR should not be below -10%.|SCR difference|-3.95|||||TWO_SIDED|95.0|-10.02|2.15||||||Comparison performed for strain A/H3N2.||2.15|-10.02|
72406274|NCT02583256|144321398|NON_INFERIORITY|The lower bound of two-sided 95% CI on the difference between SCR should not be below -10%.|SCR difference|12.95|||||TWO_SIDED|95.0|6.73|19.12||||||Comparison performed for strain B/Yamagata.||19.12|6.73|
72406275|NCT02583256|144321398|NON_INFERIORITY|The lower bound of two-sided 95% CI on the difference between SCR should not be below -10%.|SCR difference|8.36|||||TWO_SIDED|95.0|2.17|14.54||||||Comparison performed for strain B/Victoria.||14.54|2.17|
72406276|NCT04027218|144321416|SUPERIORITY||Odds Ratio (OR)|2.57||||0.001|TWO_SIDED|95.0|2.34|2.79|||McNemar|||||2.79|2.34|0.001
72406277|NCT04027218|144321416|SUPERIORITY||Odds Ratio (OR)|1.92||||0.002|TWO_SIDED|95.0|1.7|2.13|||McNemar|||||2.13|1.70|0.002
72406278|NCT04027218|144321416|SUPERIORITY||Odds Ratio (OR)|1.9||||0.004|TWO_SIDED|95.0|1.87|1.92|||McNemar|||||1.92|1.87|0.004
72406279|NCT04027218|144321417|SUPERIORITY||Median Difference (Net)|-4.179||||0|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.000
72406280|NCT04027218|144321417|SUPERIORITY||Median Difference (Net)|-3.619||||0|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.000
72406281|NCT04027218|144321417|SUPERIORITY||Median Difference (Net)|-4.099||||0|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.000
72406282|NCT04027218|144321418|SUPERIORITY||Median Difference (Net)|-1.073||||0.863|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||Estimated value corresponds with the number of negative changes, which implies participants with decrease in VAS score.|||||0.863
72522938|NCT02280096|144576157|SUPERIORITY||t-boostrap|0.9||||0.9|TWO_SIDED||||||t-test, 1 sided|||Alternation||||0.9
72406283|NCT04027218|144321418|SUPERIORITY||Median Difference (Net)|-1.267||||0.205|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||Estimated value corresponds with the number of negative changes, which implies participants with decrease in VAS score.|||||0.205
72406284|NCT04027218|144321418|SUPERIORITY||Median Difference (Net)|-0.858||||0.391|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||Estimated value corresponds with the number of negative changes, which implies participants with decrease in VAS score.|||||0.391
72406285|NCT04027218|144321420|SUPERIORITY||Median Difference (Net)|-0.672||||0.502|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||Estimated value corresponds with the absorbance comparing hemolysis in blood samples performed by clinical practice against to the corresponding intervention.|||||0.502
72522939|NCT02280096|144576158|SUPERIORITY||t-boostrap|0.83||||0.83|TWO_SIDED||||||t-test, 1 sided|||||||0.83
72522940|NCT02280096|144576159|SUPERIORITY||t-boostrap|0.92||||0.92|ONE_SIDED||||||t-test, 1 sided|||||||0.92
72406286|NCT04027218|144321420|SUPERIORITY||Median Difference (Net)|-0.327||||0.744|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||Estimated value corresponds with the absorbance comparing hemolysis in blood samples performed by clinical practice against to the corresponding intervention.|||||0.744
72406287|NCT04027218|144321420|SUPERIORITY||Median Difference (Net)|-1.885||||0.059|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||Estimated value corresponds with the absorbance comparing hemolysis in blood samples performed by clinical practice against to the corresponding intervention.|||||0.059
72406288|NCT02530294|144321422|OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||< 0.001
72406289|NCT02530294|144321423|OTHER||||||<|0.001|||||||ANCOVA|Ranked ANCOVA||||||<0.001
72406290|NCT02530294|144321424|OTHER||||||<|0.001|||||||ANCOVA|Ranked ANCOVA||||||< 0.001
72406291|NCT02530294|144321425|OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||< 0.001
72406292|NCT02530294|144321426|OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||< 0.001
72406293|NCT02103478|144321447|EQUIVALENCE|The 95% confidence intervals for the difference (oral - IV) were generated using an ANOVA model separately for Course 1 and Course 2.|Mean Difference (Final Values)|-0.144|||||TWO_SIDED|95.0|-3.165|2.876|||||Course 1|||2.876|-3.165|
72406294|NCT02103478|144321447|EQUIVALENCE|The 95% confidence intervals for the difference (oral - IV) were generated using an ANOVA model separately for Course 1 and Course 2.|Mean Difference (Final Values)|-0.087|||||TWO_SIDED|95.0|-3.463|3.288|||||Course 2|||3.288|-3.463|
72406295|NCT02103478|144321447|EQUIVALENCE|The 95% confidence intervals for the difference (oral - IV) were generated using an ANOVA model separately for Course 1 and Course 2.|Mean Difference (Final Values)|-2.588|||||TWO_SIDED|95.0|-6.074|0.899|||||Course 1|||0.899|-6.074|
72406296|NCT02103478|144321447|EQUIVALENCE|The 95% confidence intervals for the difference (oral - IV) were generated using an ANOVA model separately for Course 1 and Course 2.|Mean Difference (Final Values)|-0.096|||||TWO_SIDED|95.0|-5.08|4.888|||||Course 2|||4.888|-5.080|
72522941|NCT02280096|144576160|SUPERIORITY||t-boostrap|0.017||||0.017|TWO_SIDED||||||t-test, 1 sided|||Total moves||||0.017
72522942|NCT02280096|144576160|SUPERIORITY||t-boostrap|0.01||||0.01|TWO_SIDED||||||t-test, 1 sided|||Correct moves||||0.010
72522943|NCT02280096|144576161|SUPERIORITY||t-boostrap|0.001||||0.001|TWO_SIDED||||||t-test, 1 sided|||Execution time||||0.001
72522944|NCT02280096|144576161|SUPERIORITY||t-boostrap|0.001||||0.001|TWO_SIDED||||||t-test, 1 sided|||Problem-solving time||||0.001
72522945|NCT03605836|144576175|SUPERIORITY||Least Squares (LS) Mean Difference|-4.01|||=|0.0021|TWO_SIDED|95.0|-6.55|-1.46|||MMRM||The comparison between the centanafadine and the placebo group was tested at a significance level of 0.05.|||-1.46|-6.55|=0.0021
72522946|NCT03605836|144576175|SUPERIORITY||LS Mean Difference|-4.42|||=|0.0009|TWO_SIDED|95.0|-7.02|-1.82|||MMRM||The comparison between the centanafadine and the placebo group was tested at a significance level of 0.05.|||-1.82|-7.02|=0.0009
72522947|NCT03605836|144576176|SUPERIORITY||LS Mean Difference|-0.33|||=|0.0073|TWO_SIDED|95.0|-0.57|-0.09|||MMRM||The comparison between the centanafadine and the placebo group was tested at a significance level of 0.05.|||-0.09|-0.57|=0.0073
72522948|NCT03605836|144576176|SUPERIORITY||LS Mean Difference|-0.28|||=|0.0245|TWO_SIDED|95.0|-0.53|-0.04|||MMRM||The comparison between the centanafadine and the placebo group was tested at a significance level of 0.05.|||-0.04|-0.53|=0.0245
72522949|NCT02845440|144576186|SUPERIORITY||Odds Ratio (OR)|2.4||||0.013|TWO_SIDED|95.0|1.2|4.79||A priori threshold for significance was p \< 0.05.|Regression, Logistic|||Missing data at year 2 of intervention was imputed using MICE based on baseline characteristics and outcome values at year 1 of intervention. The statistical model was a mixed effects logistic regression with terms for TAU, AD, and AD+CHW (cohort 1) and a clinic-varying random intercept. Regression coefficients were pooled using Rubin's rule over 10 imputation runs.||4.79|1.20|0.013
72522950|NCT02845440|144576186|SUPERIORITY||Odds Ratio (OR)|1.31||||0.481|TWO_SIDED|95.0|0.62|2.74||The a priori threshold for significance was a p-value \< 0.05.|Regression, Logistic|||Missing data at year 2 of intervention was imputed using MICE based on baseline characteristics and outcome values at year 1 of intervention. The statistical model was a mixed effects logistic regression with terms for TAU, AD, and AD+CHW (cohort 1) and a clinic-varying random intercept. Regression coefficients were pooled using Rubin's rule over 10 imputation runs.||2.74|0.62|0.481
72522951|NCT02845440|144576186|SUPERIORITY||Odds Ratio (OR)|1.84||||0.036|TWO_SIDED|95.0|1.04|3.24||The a priori threshold for significance was a p-value \< 0.05.|Regression, Logistic|||Missing data at year 2 of intervention was imputed using MICE based on baseline characteristics and outcome values at year 1 of intervention. The statistical model was a mixed effects logistic regression with terms for TAU, AD, and AD+CHW (cohort 1) and a clinic-varying random intercept. Regression coefficients were pooled using Rubin's rule over 10 imputation runs.||3.24|1.04|0.036
72522952|NCT02845440|144576187|SUPERIORITY||Odds Ratio (OR)|1.35||||0.174|TWO_SIDED|95.0|0.88|2.06||The a priori threshold for significance was a p-value \< 0.05.|Regression, Logistic|||The statistical model was a mixed effects logistic regression with terms for TAU, AD, and AD+CHW (cohort 1) and a clinic-varying random intercept.||2.06|0.88|0.174
72522953|NCT02845440|144576187|SUPERIORITY||Odds Ratio (OR)|0.69||||0.092|TWO_SIDED|95.0|0.45|1.06||The a priori threshold for significance was a p-value \< 0.05.|Regression, Logistic|||The statistical model was a mixed effects logistic regression with terms for TAU, AD, and AD+CHW (cohort 1) and a clinic-varying random intercept.||1.06|0.45|0.092
72522954|NCT02845440|144576188|SUPERIORITY||Odds Ratio (OR)|2.77|||<|0.001|TWO_SIDED|95.0|1.61|4.75||The a priori threshold for significance was a p-value \< 0.05.|Regression, Logistic|||The statistical model was a mixed effects logistic regression with terms for TAU, AD, and AD+CHW (cohort 1) and a clinic-varying random intercept.||4.75|1.61|<0.001
72522955|NCT02845440|144576188|SUPERIORITY||Odds Ratio (OR)|0.9||||0.742|TWO_SIDED|95.0|0.5|1.64||The a priori threshold for significance was a p-value \< 0.05.|Regression, Logistic|||The statistical model was a mixed effects logistic regression with terms for TAU, AD, and AD+CHW (cohort 1) and a clinic-varying random intercept.||1.64|0.50|0.742
72522956|NCT02845440|144576189|SUPERIORITY||Odds Ratio (OR)|1.57||||0.056|TWO_SIDED|95.0|0.99|2.51||The a priori threshold for significance was a p-value \< 0.05.|Regression, Logistic|||Missing abstinence rates at year 2 of intervention were imputed using MICE based on baseline characteristics and abstinence rates at year 1 of intervention. The statistical model was a mixed effects logistic regression with terms for TAU, AD, and AD+CHW (cohort 1) as well as TUD medication use and a clinic-varying random intercept. Regression coefficients were pooled using Rubin's rule over 10 imputation runs.|A mediation analysis found that the estimated proportion of the effect of TUD medication use on abstinence rates attributable to the AD+CHW intervention was 2.8%.|2.51|0.99|0.056
72522957|NCT02845440|144576190|SUPERIORITY||Odds Ratio (OR)|1.97||||0.012|TWO_SIDED|95.0|1.16|3.33||The a priori threshold for significance was a p-value \< 0.05.|Regression, Logistic|||Missing abstinence rates at year 2 of intervention were imputed using MICE based on baseline characteristics and abstinence rates at year 1 of intervention. The statistical model was a mixed effects logistic regression with terms for TAU, AD, and AD+CHW (cohort 1) as well as varenicline use and a clinic-varying random intercept. Regression coefficients were pooled using Rubin's rule over 10 imputation runs.|A mediation analysis found that the estimated proportion of the effect of varenicline use on abstinence rates attributable to the AD+CHW intervention was 13.9%.|3.33|1.16|0.012
72570522|NCT02504671|144670139|OTHER||Mean Difference (Net)|-9.23||||0.002|TWO_SIDED|95.0|-14.99|-3.47||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4,SDAI|||-3.47|-14.99|0.002
72570523|NCT02504671|144670139|OTHER||Mean Difference (Net)|-5.65||||0.063|TWO_SIDED|95.0|-11.62|0.32||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 6,SDAI|||0.32|-11.62|0.063
72625070|NCT02908178|144779746|OTHER||Hazard Ratio (HR)|1.1||||0.029|TWO_SIDED|99.0|0.98|1.25||P-value is unadjusted. Threshold for statistical significance is 0.01|Chi-squared||Reference is no SLNB. Estimates are from matched cohort and adjusted for physician visits, any hospitalization in the 3-24 months prior to DCIS diagnosis, use of preoperative breast MRI, surgeon's operation volume, and receipt of radiation therapy.|Testing the association between use of sentinel lymph node biopsy (SLNB) and pain in the Aim 2 matched cohort.||1.25|0.98|0.029
72406297|NCT05107128|144321491|SUPERIORITY||Difference in Least Square (LS) Means|-1.1|STANDARD_ERROR_OF_MEAN|0.81||0.1675|TWO_SIDED|95.0|-2.7|0.5||The p-value was obtained from Mixed Model for Repeated Measures (MMRM) model which includes treatment, visit, treatment-by-visit interaction as categorical covariates, and SDMT score at baseline as a continuous covariate.|MMRM||Difference was calculated as SAGE-718 - placebo.|||0.5|-2.7|0.1675
72522958|NCT02845440|144576191|SUPERIORITY||Odds Ratio (OR)|1.71||||0.032|TWO_SIDED|95.0|1.05|2.79||The a priori threshold for significance was a p-value \< 0.05.|Regression, Logistic|||Missing data at year 2 of intervention was imputed using MICE based on baseline characteristics and outcome values at year 1 of intervention. The statistical model was a mixed effects logistic regression with terms for the factorial design (TAU, AD, CHW, and cohort) and a clinic-varying random intercept. Regression coefficients were pooled using Rubin's rule over 10 imputation runs.||2.79|1.05|0.032
72570524|NCT02504671|144670139|OTHER||Mean Difference (Net)|-6.29||||0.04|TWO_SIDED|95.0|-12.28|-0.3||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 6,SDAI|||-0.30|-12.28|0.040
72570525|NCT02504671|144670139|OTHER||Mean Difference (Net)|-6.79||||0.024|TWO_SIDED|95.0|-12.69|-0.9||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 6,SDAI|||-0.90|-12.69|0.024
72406298|NCT05107128|144321492|SUPERIORITY||Difference in LS Means|-0.6|STANDARD_ERROR_OF_MEAN|0.9||0.4872|TWO_SIDED|95.0|-2.4|1.1||The p-value was obtained from MMRM model which includes treatment, visit, treatment-by-visit interaction as categorical covariates, and UHDRS - Independence Scale at baseline as a continuous covariate.|MMRM||Difference was calculated as SAGE-718 - placebo.|||1.1|-2.4|0.4872
72522959|NCT02845440|144576191|SUPERIORITY||Odds Ratio (OR)|1.37||||0.376|TWO_SIDED|95.0|0.68|2.75||The a priori threshold for significance was a p-value \< 0.05.|Regression, Linear|||Missing data at year 2 of intervention was imputed using MICE based on baseline characteristics and outcome values at year 1 of intervention. The statistical model was a mixed effects logistic regression with terms for the factorial design (TAU, AD, CHW, and cohort) and a clinic-varying random intercept. Regression coefficients were pooled using Rubin's rule over 10 imputation runs.||2.75|0.68|0.376
72522960|NCT02845440|144576191|OTHER|Test of the additive assumption required by a factorial design. If the AD x CHW interaction is significant at p \< 0.05, the additive assumption would have to be rejected.|Odds Ratio (OR)|1.3||||0.645|TWO_SIDED|95.0|0.42|4.05|||Regression, Logistic|||Missing data at year 2 of intervention was imputed using MICE based on baseline characteristics and outcome values at year 1 of intervention. The statistical model was a mixed effects logistic regression with both additive terms and an interaction (TAU, AD, CHW, AD x CHW, and cohort) and a clinic-varying random intercept. Regression coefficients were pooled using Rubin's rule over 10 imputation runs.||4.05|0.42|0.645
72522961|NCT02845440|144576192|SUPERIORITY||Odds Ratio (OR)|1.85|||<|0.001|TWO_SIDED|95.0|1.34|2.56||The a priori threshold for significance was a p-value \< 0.05.|Regression, Logistic|The CHW intervention increased odds of self-reported use of any TUD medication by 1.85.||The statistical model was a mixed effects logistic regression with terms for the factorial design (TAU, AD, CHW, and cohort) and a clinic-varying random intercept.||2.56|1.34|<0.001
72522962|NCT02845440|144576192|SUPERIORITY||Odds Ratio (OR)|0.7||||0.084|TWO_SIDED|95.0|0.46|1.05|||Regression, Logistic|||The statistical model was a mixed effects logistic regression with terms for the factorial design (TAU, AD, CHW, and cohort) and a clinic-varying random intercept.||1.05|0.46|0.084
72522963|NCT02845440|144576192|OTHER|Test of the additive assumption required by a factorial design. If the AD x CHW interaction is significant at p \< 0.05, the additive assumption would have to be rejected.|Odds Ratio (OR)|1.22||||0.589|TWO_SIDED|95.0|0.59|2.55|||Regression, Logistic|||The statistical model was a mixed effects logistic regression with both additive terms and an interaction (TAU, AD, CHW, AD x CHW, and cohort) and a clinic-varying random intercept.||2.55|0.59|0.589
72522964|NCT02845440|144576193|SUPERIORITY||Odds Ratio (OR)|3.05|||<|0.001|TWO_SIDED|95.0|1.99|4.68||The a priori threshold for significance was a p-value \< 0.05.|Regression, Logistic|||The statistical model was a mixed effects logistic regression with terms for the factorial design (TAU, AD, CHW, and cohort) and a clinic-varying random intercept.||4.68|1.99|<0.001
72522965|NCT02845440|144576193|SUPERIORITY||Odds Ratio (OR)|0.89||||0.698|TWO_SIDED|95.0|0.51|1.57||The a priori threshold for significance was a p-value \< 0.05.|Regression, Logistic|||The statistical model was a mixed effects logistic regression with terms for the factorial design (TAU, AD, CHW, and cohort) and a clinic-varying random intercept.||1.57|0.51|0.698
72570526|NCT02504671|144670139|OTHER||Mean Difference (Net)|-6.58||||0.05|TWO_SIDED|95.0|-13.15|-0.01||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 8,SDAI|||-0.01|-13.15|0.050
72570527|NCT02504671|144670139|OTHER||Mean Difference (Net)|-9.15||||0.006|TWO_SIDED|95.0|-15.71|-2.6||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 8,SDAI|||-2.60|-15.71|0.006
72570528|NCT02504671|144670139|OTHER||Mean Difference (Net)|-8.86||||0.007|TWO_SIDED|95.0|-15.32|-2.41||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 8,SDAI|||-2.41|-15.32|0.007
72625071|NCT02908178|144779747|OTHER||Hazard Ratio (HR)|1.13||||0.861|TWO_SIDED|99.0|0.54|2.35||P-value is unadjusted. Threshold for statistical significance is 0.01.|Chi-squared||Reference is no SLNB. Estimates are from matched cohort and adjusted for physician visits, any hospitalization in the 3-24 months prior to DCIS diagnosis, use of preoperative breast MRI, surgeon's operation volume, and receipt of radiation therapy.|Testing the association between between use of sentinel lymph node biopsy (SLNB) and breast cancer specific mortality.||2.35|0.54|0.861
72406299|NCT05107128|144321493|SUPERIORITY||Difference in LS Means|-5.0|STANDARD_ERROR_OF_MEAN|6.04||0.4089|TWO_SIDED|95.0|-17.0|6.9||The p-value was obtained from MMRM model which includes treatment, visit, treatment-by-visit interaction as categorical covariates, and SDMT score at baseline as a continuous covariate.|MMRM||Difference was calculated as SAGE-718 - placebo.|||6.9|-17.0|0.4089
72522966|NCT02845440|144576193|OTHER|Test of the additive assumption required by a factorial design. If the AD x CHW interaction is significant at p \< 0.05, the additive assumption would have to be rejected.|Odds Ratio (OR)|1.1||||0.845|TWO_SIDED|95.0|0.43|2.78|||Regression, Logistic|||The statistical model was a mixed effects logistic regression with both additive terms and an interaction (TAU, AD, CHW, AD x CHW, and cohort) and a clinic-varying random intercept.||2.78|0.43|0.845
72570529|NCT02504671|144670139|OTHER||Mean Difference (Net)|-6.91||||0.074|TWO_SIDED|95.0|-14.49|0.68||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12,SDAI|||0.68|-14.49|0.074
72570530|NCT02504671|144670139|OTHER||Mean Difference (Net)|-10.37||||0.008|TWO_SIDED|95.0|-17.99|-2.74||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12,SDAI|||-2.74|-17.99|0.008
72570531|NCT02504671|144670139|OTHER||Mean Difference (Net)|-14.15|||<|0.001|TWO_SIDED|95.0|-21.64|-6.67||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12,SDAI|||-6.67|-21.64|<0.001
72570532|NCT02504671|144670139|OTHER||Mean Difference (Net)|-1.88||||0.656|TWO_SIDED|95.0|-10.19|6.43||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 16,SDAI|||6.43|-10.19|0.656
72570533|NCT02504671|144670139|OTHER||Mean Difference (Net)|-7.0||||0.093|TWO_SIDED|95.0|-15.19|1.19||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 16,SDAI|||1.19|-15.19|0.093
72406300|NCT05107128|144321494|SUPERIORITY||Difference in LS Means|0.7|STANDARD_ERROR_OF_MEAN|1.26||0.5766|TWO_SIDED|95.0|-1.78|3.19||The p-value was obtained from MMRM model which includes treatment, visit, treatment-by-visit interaction as categorical covariates, and a baseline value as a continuous covariate.|MMRM||Difference was calculated as SAGE-718 - placebo.|||3.19|-1.78|0.5766
72406301|NCT05107128|144321495|SUPERIORITY||Difference in LS Means|-0.86|STANDARD_ERROR_OF_MEAN|0.64||0.1777|TWO_SIDED|95.0|-2.13|0.39||The p-value was obtained from MMRM model which includes treatment, visit, treatment-by-visit interaction as categorical covariates, and baseline value as a continuous covariate.|MMRM||Difference was calculated as SAGE-718 - placebo.|||0.39|-2.13|0.1777
72406302|NCT05107128|144321496|SUPERIORITY||Difference in LS Means|3.9|STANDARD_ERROR_OF_MEAN|1.76||0.0291|TWO_SIDED|95.0|0.4|7.3||The p-value was obtained from MMRM model which includes treatment, visit, treatment-by-visit interaction as categorical covariates, and Hi-DEF at baseline as a continuous covariate.|MMRM||Difference was calculated as SAGE-718 - placebo.|||7.3|0.4|0.0291
72406303|NCT05107128|144321497|SUPERIORITY||Difference in LS Means|-0.1|STANDARD_ERROR_OF_MEAN|0.1||0.2923|TWO_SIDED|95.0|-0.3|0.1||The p-value was obtained from MMRM model which includes treatment, visit, treatment-by-visit interaction as categorical covariates, and CGI at baseline as a continuous covariate.|MMRM||Difference was calculated as SAGE-718 - placebo.|||0.1|-0.3|0.2923
72522967|NCT02845440|144576194|SUPERIORITY||Odds Ratio (OR)|1.42||||0.158|TWO_SIDED|95.0|0.92|2.2||The a priori threshold for significance was a p-value \< 0.05.|Regression, Logistic|||Missing abstinence rates at year 2 of intervention were imputed using MICE based on baseline characteristics and abstinence rates at year 1 of intervention. The statistical model was a mixed effects logistic regression with terms for the factorial design (TAU, AD, CHW, and cohort) as well as TUD medication use and a clinic-varying random intercept. Regression coefficients were pooled using Rubin's rule over 10 imputation runs.|A mediation analysis found that the estimated proportion of the effect of TUD medication use on abstinence rates attributable to the CHW intervention was 55.6%.|2.20|0.92|0.158
72406304|NCT02703636|144321569|OTHER|The MMRM model contained visit as a fixed effect, baseline MMSE score as a covariate and patient as a random effect.|Mean Difference (Final Values)|-0.35|STANDARD_ERROR_OF_MEAN|0.259||0.175|TWO_SIDED|95.0|-0.87|0.16|||t-test, 2 sided||change at week 24|||0.16|-0.87|0.1750
72406305|NCT02161718|144321577|SUPERIORITY||Hazard Ratio (HR)|0.91|STANDARD_ERROR_OF_MEAN|0.251||0.746|TWO_SIDED|95.0|0.53|1.56|||Log Rank|||||1.56|0.53|0.746
72406306|NCT02161718|144321578|SUPERIORITY||Hazard Ratio (HR)|0.77||||0.372|TWO_SIDED|95.0|0.43|1.37|||Andersen-Gill Recurrent-Event Cox Model|||||1.37|0.43|0.372
72522968|NCT02845440|144576195|SUPERIORITY||Odds Ratio (OR)|1.89||||0.013|TWO_SIDED|95.0|1.14|3.13||The a priori threshold for significance was a p-value \< 0.05.|Regression, Logistic|||Missing abstinence rates at year 2 of intervention were imputed using MICE based on baseline characteristics and abstinence rates at year 1 of intervention. The statistical model was a mixed effects logistic regression with terms for the factorial design (TAU, AD, CHW, and cohort) as well as varenicline use and a clinic-varying random intercept. Regression coefficients and mediation analysis estimates were pooled using Rubin's rule over 10 imputation runs.|A mediation analysis found that the estimated proportion of the effect of varenicline use on abstinence rates attributable to the CHW intervention was 36.6%.|3.13|1.14|0.013
72522969|NCT02845440|144576196|SUPERIORITY||Mean Difference (Final Values)|0.08||||0.505|TWO_SIDED|95.0|-0.16|0.33|||Regression, Linear|||The model had a clinic varying random intercept. This statistical model included cohort 1: TAU , AD, and AD+CHW||0.33|-0.16|0.505
72522970|NCT02845440|144576196|SUPERIORITY||Mean Difference (Final Values)|0.02||||0.848|TWO_SIDED|95.0|-0.22|0.27||The a priori threshold for significance was a p-value \< 0.05.|Regression, Linear|||Missing data at year 2 of intervention was imputed using MICE based on baseline characteristics and outcome values at year 1 of intervention. The statistical model was a mixed effects linear regression with terms for TAU, AD, and AD+CHW (cohort 1) and a clinic-varying random intercept. Regression coefficients were pooled using Rubin's rule over 10 imputation runs.||0.27|-0.22|0.848
72522971|NCT02845440|144576196|SUPERIORITY||Mean Difference (Final Values)|0.06||||0.529|TWO_SIDED|95.0|-0.13|0.25||The a priori threshold for significance was a p-value \< 0.05.|Regression, Linear|||Missing data at year 2 of intervention was imputed using MICE based on baseline characteristics and outcome values at year 1 of intervention. The statistical model was a mixed effects linear regression with terms for TAU, AD, and AD+CHW (cohort 1) and a clinic-varying random intercept. Regression coefficients were pooled using Rubin's rule over 10 imputation runs.||0.25|-0.13|0.529
72522972|NCT02845440|144576197|SUPERIORITY||Mean Difference (Final Values)|0.01||||0.937|TWO_SIDED|95.0|-0.16|0.18|||Regression, Linear|||Missing data at year 2 of intervention was imputed using MICE based on baseline characteristics and outcome values at year 1 of intervention. The statistical model was a mixed effects linear regression with terms for the factorial design (TAU, AD, CHW, and cohort) and a clinic-varying random intercept. Regression coefficients were pooled using Rubin's rule over 10 imputation runs.||0.18|-0.16|0.937
72406307|NCT02161718|144321579|SUPERIORITY||Odds Ratio (OR)|0.99||||0.963|TWO_SIDED|95.0|0.56|1.73|||Regression, Logistic|||||1.73|0.56|0.963
72406308|NCT01205165|144321605|SUPERIORITY_OR_OTHER|||||||0||95.0||||P-value is calculated from Wilcoxon signed rank test to compare difference between baseline and week12|Wilcoxon signed rank test|||Baseline and Week 12||||0.00000
72406309|NCT02942017|144321616|SUPERIORITY||Least Square (LS) Mean Difference|-2.5|STANDARD_ERROR_OF_MEAN|1.019||0.016|TWO_SIDED|95.0|-4.52|-0.48|||MMRM|||Mixed effect model for repeated measures (MMRM) was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.48|-4.52|0.0160
72406310|NCT02942017|144321617|SUPERIORITY||LS Mean Difference|0.54|STANDARD_ERROR_OF_MEAN|1.271||0.671|TWO_SIDED|95.0|-1.98|3.07|||MMRM|||MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||3.07|-1.98|0.6710
72522973|NCT02845440|144576197|SUPERIORITY||Median Difference (Final Values)|0.05||||0.683|TWO_SIDED|95.0|-0.19|0.29|||Regression, Linear|||Missing data at year 2 of intervention was imputed using MICE based on baseline characteristics and outcome values at year 1 of intervention. The statistical model was a mixed effects linear regression with terms for the factorial design (TAU, AD, CHW, and cohort) and a clinic-varying random intercept. Regression coefficients were pooled using Rubin's rule over 10 imputation runs.||0.29|-0.19|0.683
72522974|NCT02845440|144576197|OTHER|Test of the additive assumption required by a factorial design. If the AD x CHW interaction is significant at p \< 0.05, the additive assumption would have to be rejected.|Mean Difference (Final Values)|0.3||||0.19|TWO_SIDED|95.0|-0.15|0.74|||Regression, Linear|||Missing data at year 2 of intervention was imputed using MICE based on baseline characteristics and outcome values at year 1 of intervention. The statistical model was a mixed effects linear regression with both additive terms and an interaction (TAU, AD, CHW, AD x CHW, and cohort) and a clinic-varying random intercept. Regression coefficients were pooled using Rubin's rule over 10 imputation runs.||0.74|-0.15|0.190
72522975|NCT02057068|144576198|SUPERIORITY||||||<|0.001|||||||ANOVA|Intention to treat analysis with last observation carried forward|||Partial Eta Squared = .282|||<.001
72522976|NCT02057068|144576199|SUPERIORITY|Intention to treat analysis with last observation carried forward|||||>|0.05|||||||ANOVA|||||||>.05
72522977|NCT02057068|144576200|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<.05
72522978|NCT01024920|144576208|OTHER|||||||0.8531||||||P-value for comparison of Kaplan-Meier estimates at 9 months using normal approximation test (two-sided).|Normal approximation test|||||||0.8531
72522979|NCT01024920|144576210|OTHER||Hazard Ratio (HR)|1.12||||0.6395|TWO_SIDED|95.0|0.697|1.8|||Log Rank||Hazard ratio from Cox proportional hazards model stratified by Motzer risk score and previous surgery.|A stratified log-rank test (two-sided, 0.05 significance level) was used to test the effect of nintedanib on PFS compared with sunitinib. The test was stratified by Motzer risk score category (low/intermediate or high) and prior nephrectomy surgery for Renal Cell Cancer (yes or no).||1.800|0.697|0.6395
72522980|NCT01024920|144576211|OTHER||Odds Ratio (OR)|0.484||||0.1213|TWO_SIDED|95.0|0.193|1.212|||Regression, Logistic||Odds ratio \> 1 favours nintedanib.|A logistic regression model stratified by Motzer risk score category and prior surgery for renal cell cancer (RCC) was used to compare the objective response rate between the two treatment arms. The corresponding odds ratio and 95% Confidence Intervals was also presented.||1.212|0.193|0.1213
72522981|NCT01024920|144576213|OTHER||Hazard Ratio (HR)|0.92||||0.7593|TWO_SIDED|95.0|0.542|1.564||P-value from log-rank stratified by Motzer risk score and previous surgery.|Log Rank||Hazard ratio from Cox proportional hazards model stratified by Motzer risk score and previous surgery. Hazard ratio \< 1 favours nintedanib.|||1.564|0.542|0.7593
72522982|NCT01024920|144576214|OTHER||Cox Proportional Hazard|1.143||||0.5958|TWO_SIDED|95.0|0.697|1.873|||Log Rank|P-value from log-rank stratified by Motzer risk score and previous surgery.|Hazard ratio from Cox proportional hazards model stratified by Motzer risk score and previous surgery. Hazard ratio \< 1 favours nintedanib.|||1.873|0.697|0.5958
72522983|NCT01024920|144576215|OTHER||Hazard Ratio (HR)|1.142||||0.5712|TWO_SIDED|95.0|0.72|1.812|||Log Rank|P-value from log-rank stratified by Motzer risk score and previous surgery (two-sided).|Hazard ratio from Cox proportional hazards model stratified by Motzer risk score and previous surgery. Hazard ratio \< 1 favours nintedanib.|||1.812|0.720|0.5712
72522984|NCT02977507|144576251|OTHER|||||||0.041|||||||Paired t-test|||Testing hypothesis was that the mean change from baseline was zero.||||0.041
72522985|NCT02977507|144576251|OTHER|||||||0.0005|||||||Paired t-test|||Testing hypothesis was that the mean change from baseline was zero.||||0.0005
72522986|NCT02977507|144576252|OTHER|||||||0.002|||||||Paired t-test|||Testing hypothesis was that the mean change from baseline was zero.||||0.002
72570534|NCT02504671|144670139|OTHER||Mean Difference (Net)|-7.26||||0.076|TWO_SIDED|95.0|-15.3|0.78||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 16,SDAI|||0.78|-15.30|0.076
72570535|NCT02504671|144670139|OTHER||Mean Difference (Net)|0.8||||0.86|TWO_SIDED|95.0|-8.14|9.74||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 20,SDAI|||9.74|-8.14|0.860
72570536|NCT02504671|144670139|OTHER||Mean Difference (Net)|-5.71||||0.196|TWO_SIDED|95.0|-14.4|2.99||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 20,SDAI|||2.99|-14.40|0.196
72570537|NCT02504671|144670139|OTHER||Mean Difference (Net)|-6.0||||0.164|TWO_SIDED|95.0|-14.48|2.48||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 20,SDAI|||2.48|-14.48|0.164
72522987|NCT02977507|144576252|OTHER|||||||0.0001|||||||Paired t-test|||Testing hypothesis was that the mean change from baseline was zero.||||0.0001
72522988|NCT02977507|144576253|OTHER|||||||0.004|||||||Paired t-test|||Testing hypothesis was that the mean change from baseline was zero.||||0.004
72522989|NCT02977507|144576253|OTHER|||||||0.001|||||||Paired t-test|||Testing hypothesis was that the mean change from baseline was zero.||||0.001
72522990|NCT02977507|144576257|OTHER|||||||0.003|||||||Paired t-test|||Testing hypothesis was that the mean change from baseline was zero.||||0.003
72522991|NCT02977507|144576257|OTHER|||||||0.0007|||||||Paired t-test|||Testing hypothesis was that the mean change from baseline was zero.||||0.0007
72522992|NCT02977507|144576259|OTHER|||||||0.569|||||||Paired t-test|||Melanin index: Testing hypothesis is that the mean change from baseline is zero.||||0.569
72522993|NCT02977507|144576259|OTHER|||||||9e-05|||||||Paired t-test|||Melanin index: Testing hypothesis is that the mean change from baseline is zero.||||0.00009
72522994|NCT02977507|144576259|OTHER|||||||0.821|||||||Paired t-test|||Erythema: Testing hypothesis is that the mean change from baseline is zero.||||0.821
72522995|NCT02977507|144576259|OTHER|||||||0.502|||||||Paired t-test|||Erythema: Testing hypothesis is that the mean change from baseline is zero.||||0.502
72522996|NCT02977507|144576259|OTHER|||||||0.81|||||||Paired t-test|||Melanin index: Testing hypothesis is that the mean change from baseline is zero.||||0.810
72522997|NCT02977507|144576259|OTHER|||||||0.435|||||||Paired t-test|||Erythema: Testing hypothesis is that the mean change from baseline is zero.||||0.435
72522998|NCT00633360|144576271|SUPERIORITY_OR_OTHER|||||||0.59|||||||Wilcoxon (Mann-Whitney)|||||||.59
72522999|NCT00633360|144576272|SUPERIORITY_OR_OTHER|||||||0.29|||||||t-test, 2 sided|||||||.29
72523000|NCT02972593|144576286|OTHER|Data collapsed to participant level, creating an ever/never response for each participant for each infection outcome type. Analyses performed at the participant level to determine if proportion of outcome types were similar between transfusion groups using Fisher's Exact tests, due to small expected cell counts, using SAS v9.4 (SAS Institute, Cary, NC). Power analyses performed based on these proportions using bootstrapping methods in SAS and confirmed with nQuery v8.7.1.0.||||||0.0122|||||||Fisher Exact|||||||.0122
72523001|NCT02972593|144576287|OTHER|||||||0.7742|||||||Fisher Exact|||||||.7742
72523002|NCT02972593|144576288|OTHER|||||||0.1443|||||||t-test, 1 sided|||||||.1443
72523003|NCT03241589|144576289|SUPERIORITY||Odds Ratio (OR)|0.931||||0.7428|TWO_SIDED|95.0|0.606|1.429|||Regression, Logistic||Referent group is Urban|We followed power calculations described in uploaded protocol document, using an incomplete design matrix with a 3-month transition period, a level of precision α=0.05 and a minimum power level of 0.80. We also assumed a total number of clusters I=36 as per the study design and the number of baseline measurements B=2. Due to insufficient sample size, we modified groups studied.||1.429|0.606|0.7428
72523004|NCT03241589|144576290|SUPERIORITY||Odds Ratio (OR)|2.258||||0.0031|TWO_SIDED|95.0|1.181|4.315|||Regression, Logistic|2 degrees of freedom, Wald Chi-Square 11.5759|Veterans with expired requests = referent.|||4.315|1.181|0.0031
72523005|NCT04599972|144576292|SUPERIORITY||Odds Ratio (OR)|2.979|||<|0.01|TWO_SIDED|95.0|1.753|5.064|||Regression, Logistic|||All treatment comparisons for primary and secondary endpoints related to BDCVA were conducted with a logistic regression model including fixed effects of baseline BDCVA at 40 cm as a covariate and treatment.||5.064|1.753|<0.01
72523006|NCT04599972|144576293|SUPERIORITY||Odds Ratio (OR)|2.807|||<|0.01|TWO_SIDED|95.0|1.655|4.762|||Regression, Logistic|||||4.762|1.655|<0.01
72523007|NCT04599972|144576294|SUPERIORITY||Odds Ratio (OR)|6.002|||<|0.01|TWO_SIDED|95.0|3.431|10.499|||Regression, Logistic|||||10.499|3.431|<0.01
72406311|NCT02942017|144321618|SUPERIORITY||LS Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.738||0.4216|TWO_SIDED|95.0|-2.06|0.87|||MMRM|||Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.87|-2.06|0.4216
72523008|NCT04599972|144576295|SUPERIORITY||Odds Ratio (OR)|4.161|||<|0.01|TWO_SIDED|95.0|2.404|7.204|||Regression, Logistic|||||7.204|2.404|<0.01
72523009|NCT01594411|144576298|SUPERIORITY_OR_OTHER||||||<|0.001|||||||one-sided binomial with alpha level of 0|||"The proportion of patients whose final treatment plan changes from the preliminary will be estimated, and a one-sided binomial test with alpha level of .05 will be used to test whether it is greater than 10%.~This is the level at which it is assumed that patient management has been modified by a practically important amount."||||<0.001
72523010|NCT01620593|144576300|SUPERIORITY|t-test|||||<|0.05|||||||t-test, 2 sided|||||||<0.05
72523011|NCT00323427|144576351|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.039|STANDARD_ERROR_OF_MEAN|0.0974||0.69|TWO_SIDED|95.0|-0.15|0.23||No multiple testing adjustment.|t-test, 2 sided|||H0: Mean(Arm 1) = Mean(Arm 2)||0.23|-0.15|0.69
72523012|NCT00323427|144576352|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.11|STANDARD_ERROR_OF_MEAN|0.14||0.42|TWO_SIDED|95.0|-0.16|0.38||No adjustment.|t-test, 2 sided|||H0: Mean(Arm 1) = Mean(Arm 2)||0.38|-0.16|0.42
72523013|NCT00323427|144576353|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.004|STANDARD_ERROR_OF_MEAN|0.15||0.97|TWO_SIDED|95.0|-0.3|0.29||No adjustment|t-test, 2 sided|||H0: mean(Arm 1) = Mean (Arm 2)||0.29|-0.30|0.97
72523014|NCT03039192|144576358|SUPERIORITY||Difference of Least Square Means|-3.8|STANDARD_ERROR_OF_MEAN|1.39||0.006|TWO_SIDED|95.0|-6.56|-1.09|||ANCOVA|||||-1.09|-6.56|0.006
72523015|NCT02493868|144576381|SUPERIORITY||Hazard Ratio (HR)|0.49|||=|0.003|TWO_SIDED|95.0|0.29|0.84|||Weighted Log-rank|||||0.84|0.29|= 0.003
72523016|NCT02407236|144576399|SUPERIORITY||Adjusted treatment difference|10.3|||<|0.001|TWO_SIDED|95.0|5.7|14.9|||Cochran-Mantel-Haenszel||Treatment difference between ustekinumab group and placebo group was adjusted with Cochran-Mantel-Haenszel (CMH) weight.|Statistical Analysis 1||14.9|5.7|< 0.001
72523017|NCT02407236|144576399|SUPERIORITY||Adjusted treatment difference|10.2|||<|0.001|TWO_SIDED|95.0|5.6|14.8|||Cochran-Mantel-Haenszel||Treatment difference between ustekinumab group and placebo group was adjusted with Cochran-Mantel-Haenszel (CMH) weight.|Statistical Analysis 2||14.8|5.6|< 0.001
72523018|NCT02407236|144576400|SUPERIORITY||Adjusted treatment difference|10.3|||<|0.001|TWO_SIDED|97.5|4.8|15.8|||Cochran-Mantel-Haenszel||Treatment difference between ustekinumab group and placebo group was adjusted with Cochran-Mantel-Haenszel (CMH) weight.|Statistical Analysis 1||15.8|4.8|< 0.001
72523019|NCT02407236|144576400|SUPERIORITY||Adjusted treatment difference|12.7|||<|0.001|TWO_SIDED|97.5|7.0|18.4|||Cochran-Mantel-Haenszel||Treatment difference between ustekinumab group and placebo group was adjusted with Cochran-Mantel-Haenszel (CMH) weight.|Statistical Analysis 2||18.4|7.0|< 0.001
72523020|NCT02407236|144576401|SUPERIORITY||Adjusted treatment difference|14.5||||0.002|TWO_SIDED|95.0|5.5|23.6|||Cochran-Mantel-Haenszel||Treatment difference between ustekinumab group and placebo group was adjusted with CMH weight.|Statistical Analysis 1||23.6|5.5|0.002
72523021|NCT02407236|144576401|SUPERIORITY||Adjusted treatment difference|19.7|||<|0.001|TWO_SIDED|95.0|10.3|29.0|||Cochran-Mantel-Haenszel||Treatment difference between ustekinumab group and placebo group was adjusted with CMH weight.|Statistical Analysis 2||29.0|10.3|< 0.001
72523022|NCT02407236|144576402|SUPERIORITY||Adjusted treatment difference|15.1||||0.002|TWO_SIDED|95.0|6.0|24.2|||Cochran-Mantel-Haenszel||Treatment difference between ustekinumab group and placebo group was adjusted with CMH weight.|Statistical Analysis 1||24.2|6.0|0.002
72523023|NCT02407236|144576402|SUPERIORITY||Adjusted treatment difference|17.9|||<|0.001|TWO_SIDED|95.0|8.6|27.2|||Cochran-Mantel-Haenszel||Treatment difference between ustekinumab group and placebo group was adjusted with CMH weight.|Statistical Analysis 2||27.2|8.6|< 0.001
72523024|NCT01951326|144576502|SUPERIORITY|||||||0.0048|||||||Cochran-Mantel-Haenszel|Stratified according to anti-TNF agent use (Y/N).||||||0.0048
72523025|NCT01951326|144576503|SUPERIORITY|||||||0.0116|||||||Cochran-Mantel-Haenszel|Stratified according to anti-TNF agent use (Y/N).||||||0.0116
72523026|NCT01951326|144576504|SUPERIORITY|||||||0.0616|||||||Cochran-Mantel-Haenszel|Stratified according to anti-TNF agent use (Y/N).||||||0.0616
72523027|NCT01951326|144576505|SUPERIORITY|||||||0.0851|||||||Cochran-Mantel-Haenszel|Stratified according to anti-TNF agent use (Y/N).||||||0.0851
72523028|NCT01951326|144576506|SUPERIORITY|||||||0.0147|||||||Cochran-Mantel-Haenszel|Stratified according to anti-TNF agent use (Y/N).||||||0.0147
72523029|NCT01951326|144576507|SUPERIORITY|||||||0.151|||||||Cochran-Mantel-Haenszel|Stratified according to anti-TNF agent use (Y/N).||||||0.1510
72523030|NCT01951326|144576508|SUPERIORITY|||||||0.2402|||||||Log Rank|||||||0.2402
72523031|NCT01951326|144576509|SUPERIORITY|||||||0.046|||||||Log Rank|||||||0.0460
72523032|NCT01951326|144576510|SUPERIORITY|||||||0.0031|||||||Log Rank|||||||0.0031
72523033|NCT01951326|144576511|SUPERIORITY|||||||0.01|||||||Log Rank|||||||0.0100
72523034|NCT01951326|144576512|SUPERIORITY|||||||0.0077|||||||Cochran-Mantel-Haenszel|Stratified according to anti-TNF agent use (Y/N).||||||0.0077
72523035|NCT01951326|144576513|SUPERIORITY|||||||0.0422|||||||Cochran-Mantel-Haenszel|Stratified according to anti-TNF agent use (Y/N).||||||0.0422
72523036|NCT01726504|144576529|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|95.0|||||Mixed Models Analysis|||During the 8-week treatment period, the adjusted change from baseline in mean weekly CSBMs was 1.72 ± 0.12 (95% CI, 1.48 to 1.96) in the EA group and 0.82 ± 0.13 (95% CI, 0.58 to 1.07, P\<0.001) times more than that in the SA group.||||<0.001
72523037|NCT03531762|144576543|OTHER||Ratio of Geometric Least Square Mean|108.87|||||TWO_SIDED|90.0|101.2|117.13||||||||117.13|101.20|
72523038|NCT03531762|144576544|OTHER||Ratio of Geometric Least Square Mean|109.8|||||TWO_SIDED|90.0|101.69|118.55||||||||118.55|101.69|
72523039|NCT03531762|144576545|OTHER||Ratio of Geometric Least Square Mean|104.1|||||TWO_SIDED|90.0|92.93|116.61||||||||116.61|92.93|
72523040|NCT00364832|144576573|SUPERIORITY_OR_OTHER||Estimated Conversion Factor 90% CI|0.81|||||TWO_SIDED|90.0|0.73|0.9|||||To analyze dose conversion factors (CF), 2nd regression (R) analysis was performed on 3 different CF dose groups, using the R slope estimates of Hb change over 6 weeks. Equi-effective CF was interpolated using value that gives an Hb change of zero.|All cohorts with dosing frequency 1x/ week (0.4, 0.8 and 1.2 dose group)||0.90|0.73|
72570538|NCT02504671|144670139|OTHER||Mean Difference (Net)|-10.65||||0.066|TWO_SIDED|95.0|-21.99|0.69||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24,SDAI|||0.69|-21.99|0.066
72406312|NCT02942017|144321618|SUPERIORITY||LS Mean Difference|-0.77|STANDARD_ERROR_OF_MEAN|0.905||0.3947|TWO_SIDED|95.0|-2.57|1.02|||MMRM|||Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model. All explanatory variables including pooled center were treated as fixed effects.||1.02|-2.57|0.3947
72523041|NCT00364832|144576573|SUPERIORITY_OR_OTHER||Estimated Conversion Factor 90% CI|0.72|||||TWO_SIDED|90.0|0.55|0.86|||||To analyze dose conversion factors (CF), 2nd regression (R) analysis was performed on 3 different CF dose groups, using the R slope estimates of Hb change over 6 weeks. Equi-effective CF was interpolated using value that gives an Hb change of zero.|All cohorts with dosing frequency 1x/ 3 weeks (0.4, 0.8 and 1.2 dose group)||0.86|0.55|
72523042|NCT00364832|144576573|SUPERIORITY_OR_OTHER||Estimated Conversion Factor 90% CI|0.93|||||TWO_SIDED|90.0|0.81|1.09|||||To analyze dose conversion factors (CF), 2nd regression (R) analysis was performed on 3 different CF dose groups, using the R slope estimates of Hb change over 6 weeks. Equi-effective CF was interpolated using value that gives an Hb change of zero.|All cohorts with dosing frequency 1x/ 4 weeks (0.4, 0.8 and 1.2 dose group)||1.09|0.81|
72523043|NCT00068822|144576579|SUPERIORITY_OR_OTHER||Adjusted treatment effect|0.7||||0.49|TWO_SIDED|95.0|-1.3|2.8|||ANCOVA|||Between group comparisons, confidence intervals, and P values were calculated with the use of analysis-of-covariance models with adjustment for study group assignment, baseline value of the outcome measure, and study center. Negative treatment effects favor the control procedure, and positive treatment effects favor vertebroplasty.||2.8|-1.3|0.49
72523044|NCT00068822|144576580|SUPERIORITY_OR_OTHER||Treatment Effect|1.0||||0.45|TWO_SIDED|95.0|-1.7|3.7|||ANCOVA|||SF-36 Physical Component Summary treatment effect||3.7|-1.7|0.45
72523045|NCT00068822|144576580|SUPERIORITY_OR_OTHER||Treatment Effect|1.0||||0.83|TWO_SIDED|95.0|-3.7|4.6|||ANCOVA|||SF-36 Mental Component Summary treatment effect||4.6|-3.7|0.83
72523046|NCT00068822|144576580|SUPERIORITY_OR_OTHER||Treatment Effect|0.2||||0.33|TWO_SIDED|95.0|-0.2|0.6|||ANCOVA|||Pain Frequency Index treatment effect||0.6|-0.2|0.33
72523047|NCT00068822|144576580|SUPERIORITY_OR_OTHER||Treatment Effect|0.33||||0.33|TWO_SIDED|95.0|-0.2|0.6|||ANCOVA|||Pain Bothersome Index treatment effect||0.6|-0.2|0.33
72523048|NCT00068822|144576580|SUPERIORITY_OR_OTHER||Treatment Effect|0.05||||0.13|TWO_SIDED|95.0|-0.01|0.11|||ANCOVA|||EQ-5D Index treatment effect||0.11|-0.01|0.13
72523049|NCT00068822|144576580|SUPERIORITY_OR_OTHER||Treatment Effect|0.4||||0.5|TWO_SIDED|95.0|-0.8|1.6|||ANCOVA|||SOF-ADL treatment effect||1.6|-0.8|0.5
72523050|NCT00068822|144576581|SUPERIORITY_OR_OTHER||Adjusted treatment effect|0.7||||0.19|TWO_SIDED|95.0|-0.3|1.7|||ANCOVA|||Between group comparisons, confidence intervals, and P values were calculated with the use of analysis-of-covariance models with adjustment for study group assignment, baseline value of the outcome measure, and study center. Negative treatment effects favor the control procedure, and positive treatment effects favor vertebroplasty.||1.7|-0.3|0.19
72523051|NCT00617162|144576587|SUPERIORITY||Mean Difference (Final Values)|-1.6||||0.3989|TWO_SIDED|95.0|-5.5|2.2|||Fisher Exact|||||2.2|-5.5|0.3989
72523052|NCT00735072|144576596|SUPERIORITY_OR_OTHER_LEGACY|||||||0.014||95.0|||||Wilcoxon (Mann-Whitney)|||Null hypothesis: there will be no difference in the week 24 change in %activated CD8+ T cells between arms. Assuming a standard deviation as high as 3.5% and a Type I error of 5%, with 21 subjects in each treatment arm we would have 80% statistical power to detect a mean 3 percentage-point difference in the percent of activated CD8+ T cells between the active drug and placebo groups.||||0.014
72523053|NCT00735072|144576597|OTHER|||||||0.97|||||||Mixed Models Analysis|||||||0.97
72523054|NCT00735072|144576598|OTHER|||||||0.33|||||||Mixed Models Analysis|||||||0.33
72523055|NCT03377452|144576631|SUPERIORITY||Mean Difference (Final Values)|7.26|STANDARD_ERROR_OF_MEAN|6.02||0.2313|TWO_SIDED|95.0|-4.71|19.22|||t-test, 2 sided|||||19.22|-4.71|0.2313
72570539|NCT02504671|144670139|OTHER||Mean Difference (Net)|-16.37||||0.003|TWO_SIDED|95.0|-27.25|-5.49||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24,SDAI|||-5.49|-27.25|0.003
72406313|NCT02942017|144321618|SUPERIORITY||LS Mean Difference|-0.95|STANDARD_ERROR_OF_MEAN|0.962||0.328|TWO_SIDED|95.0|-2.86|0.96|||MMRM|||Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.96|-2.86|0.3280
72406314|NCT02942017|144321618|SUPERIORITY||LS Mean Difference|-1.14|STANDARD_ERROR_OF_MEAN|0.994||0.2522|TWO_SIDED|95.0|-3.12|0.83|||MMRM|||Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.83|-3.12|0.2522
72406315|NCT02942017|144321618|SUPERIORITY||LS Mean Difference|-1.61|STANDARD_ERROR_OF_MEAN|1.091||0.1431|TWO_SIDED|95.0|-3.78|0.55|||MMRM|||Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.55|-3.78|0.1431
72406316|NCT02942017|144321618|SUPERIORITY||LS Mean Difference|-1.85|STANDARD_ERROR_OF_MEAN|1.113||0.0991|TWO_SIDED|95.0|-4.06|0.36|||MMRM|||Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.36|-4.06|0.0991
72406317|NCT02942017|144321618|SUPERIORITY||LS Mean Difference|-2.42|STANDARD_ERROR_OF_MEAN|1.155||0.0389|TWO_SIDED|95.0|-4.71|-0.13|||MMRM|||Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.13|-4.71|0.0389
72406318|NCT02942017|144321618|SUPERIORITY||LS Mean Difference|-3.48|STANDARD_ERROR_OF_MEAN|1.108||0.0022|TWO_SIDED|95.0|-5.67|-1.28|||MMRM|||Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-1.28|-5.67|0.0022
72406319|NCT02942017|144321618|SUPERIORITY||LS Mean Difference|-3.24|STANDARD_ERROR_OF_MEAN|1.429||0.0255|TWO_SIDED|95.0|-6.08|-0.4|||MMRM|||Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.40|-6.08|0.0255
72406320|NCT02942017|144321618|SUPERIORITY||LS Mean Difference|-2.03|STANDARD_ERROR_OF_MEAN|1.356||0.1375|TWO_SIDED|95.0|-4.73|0.66|||MMRM|||Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.66|-4.73|0.1375
72523056|NCT03377452|144576632|SUPERIORITY||Mean Difference (Net)|-3.31|STANDARD_ERROR_OF_MEAN|0.81|<|0.001|TWO_SIDED|95.0|-4.91|-1.72|||Mixed Models Analysis||The parameter estimate is the change in the outcome from baseline to 3-months after the last intervention/control session for the intervention group versus the same change in the control group.|||-1.72|-4.91|<0.001
72523057|NCT05179057|144576645|SUPERIORITY|A logistic regression model included treatment, level of viremia at baseline (≥10,000 copies/mL or \<10,000 copies/mL adenovirus DNA), age (≥12 years or \<12 years), and absolute lymphocyte counts at baseline. The null hypothesis is that the true percentage for posoleucel plus SoC is less than or equal to the true percentage for placebo plus SoC, and the alternative hypothesis is that it is greater.|Odds Ratio (OR)|0.98|||||TWO_SIDED|95.0|0.26|3.69|||||Posoleucel versus Placebo|||3.69|0.26|
72523058|NCT03146403|144576652|SUPERIORITY|||||||0.7474|||||||Wilcoxon (Mann-Whitney)|||||||0.7474
72523059|NCT03146403|144576653|SUPERIORITY|||||||0.645|||||||Wilcoxon (Mann-Whitney)|||||||0.6450
72523060|NCT03146403|144576654|SUPERIORITY|||||||0.3157|||||||Chi-squared|||||||0.3157
72570540|NCT02504671|144670139|OTHER||Mean Difference (Net)|-15.67||||0.004|TWO_SIDED|95.0|-26.3|-5.03||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24,SDAI|||-5.03|-26.30|0.004
72570541|NCT02504671|144670139|OTHER||Mean Difference (Net)|-4.78||||0.024|TWO_SIDED|95.0|-8.91|-0.65||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 1,SDAI|||-0.65|-8.91|0.024
72523061|NCT03146403|144576655|SUPERIORITY|||||||0.3869|||||||Log Rank|||||||0.3869
72523062|NCT03146403|144576656|SUPERIORITY|||||||0.22|||||||Wilcoxon (Mann-Whitney)|||||||0.2200
72523063|NCT00926185|144576679|SUPERIORITY_OR_OTHER_LEGACY||Treatment Effect|0.06||||0.9381|TWO_SIDED|95.0|-0.26|0.39|||Dunnett's test||Analysis of covariance model with treatment, baseline, and site.|||0.39|-0.26|0.9381
72523064|NCT00926185|144576679|SUPERIORITY_OR_OTHER_LEGACY||Treatment Effect|0.2||||0.3585|TWO_SIDED|95.0|-0.13|0.53|||Dunnett's test||Analysis of covariance model with treatment, baseline, and site.|||0.53|-0.13|0.3585
72523065|NCT00926185|144576679|SUPERIORITY_OR_OTHER_LEGACY||Treatment Effect|0.27||||0.1375|TWO_SIDED|95.0|-0.06|0.6|||Dunnett's test||Analysis of covariance model with treatment, baseline, and site.|||0.60|-0.06|0.1375
72570542|NCT02504671|144670139|OTHER||Mean Difference (Net)|-7.77|||<|0.001|TWO_SIDED|95.0|-11.84|-3.7||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 1,SDAI|||-3.70|-11.84|<0.001
72523066|NCT02069704|144576681|EQUIVALENCE|Two treatments are judged not to be different from one another if the 90% CI of the ratio of a log-transformed exposure measure (AUC) falls completely within the range 80%-125%.|ratio BEVZ92 to Avastin|99.4|||||TWO_SIDED|90.0|90.5|109.0|||||For the ratio: BEVZ92 represents the numerator and reference bevacizumab the denominator|Based on previously published PK data for reference bevacizumab in metastatic colorectal cancer, we assumed a conservative inter-participant coefficient of variation for AUC of around 35%. A sample size of 51 patients in each treatment arm could show bioequivalence with a nominal power of 90% and an α of 0·05, if the 90% CIs for the ratio of BEVZ92 to reference bevacizumab of the geometric means for AUC0-336h and AUCss were within the acceptance interval of 80%-125%.||109.0|90.5|
72523067|NCT02069704|144576682|EQUIVALENCE|Two treatments are judged not to be different from one another if the 90% CI of the ratio of a log-transformed exposure measure (AUC) falls completely within the range 80%-125%.|ratio BEVZ92 to Avastin|100.0|||||TWO_SIDED|90.0|90.2|112.0||||||||112.0|90.2|
72523068|NCT03949621|144576694|OTHER|Geometric least-squares means (LSMs) were calculated by exponentiating the LSMs derived from analysis of covariance (ANCOVA) with weight as a covariate. Confidence intervals (CIs) were calculated using treatment standard errors from the ANCOVA model and t-statistic for error degrees of freedom.|Ratio of Geometric LSMs|0.9632|||||TWO_SIDED|90.0|0.7938|1.1688||||||||1.1688|0.7938|
72523069|NCT03949621|144576695|OTHER|Geometric LSMs were calculated by exponentiating the LSMs derived from ANCOVA with weight as a covariate. CIs were calculated using treatment standard errors from the ANCOVA model and t-statistic for error degrees of freedom.|Ratio of Geometric LSMs|0.9606|||||TWO_SIDED|90.0|0.798|1.1562||||||||1.1562|0.798|
72523070|NCT03949621|144576696|OTHER|Geometric LSMs were calculated by exponentiating the LSMs derived from ANCOVA with weight as a covariate. CIs were calculated using treatment standard errors from the ANCOVA model and t-statistic for error degrees of freedom.|Ratio of Geometric LSMs|1.0162|||||TWO_SIDED|90.0|0.9001|1.1473||||||||1.1473|0.9001|
72523071|NCT01236768|144576699|EQUIVALENCE|Comparative analysis of AG200-15 and Levora for breakthrough bleeding and/or spotting.||||||0.089|||||||Chi-squared|||Comparative evaluation of AG200-15 and Levora||||0.089
72523072|NCT00638690|144576703|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.646|||<|0.0001|TWO_SIDED|95.0|0.543|0.768||Nominal P-value is 0.0142 at interim analysis based on group sequential design.|Log Rank|This was a stratified analysis.||||0.768|0.543|<0.0001
72523073|NCT00638690|144576704|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.58|||<|0.0001||95.0|0.462|0.728||Nominal P-value = 0.05.|Log Rank|This was a stratified analysis.||||0.728|0.462|<0.0001
72523074|NCT00638690|144576705|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|5.266|||<|0.001|TWO_SIDED|95.0|3.459|8.018||Nominal P-value = 0.05.|Chi-squared|||||8.018|3.459|<0.001
72523075|NCT00638690|144576706|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.673|||<|0.0001|TWO_SIDED|95.0|0.585|0.776||The nominal P-value = 0.05.|Log Rank|This was a stratified analysis.||||0.776|0.585|<0.0001
72523076|NCT00605358|144576707|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.4||||0.018|TWO_SIDED|95.0|1.17|4.93|||Chi-squared|||Participants in the Open Door Intervention and the Services Referral condition were compared on rates of engagement in mental health services over the study follow-up period.||4.93|1.17|.018
72523077|NCT02861118|144576708|OTHER|||||||0.024|||||||Regression, Logistic|||IBD||||0.024
72570543|NCT02504671|144670139|OTHER||Mean Difference (Net)|-6.67||||0.01|TWO_SIDED|95.0|-11.74|-1.6||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 2,SDAI|||-1.60|-11.74|0.010
72570544|NCT02504671|144670139|OTHER||Mean Difference (Net)|-6.85||||0.008|TWO_SIDED|95.0|-11.91|-1.78||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 2,SDAI|||-1.78|-11.91|0.008
72406321|NCT02942017|144321618|SUPERIORITY||LS Mean Difference|-0.33|STANDARD_ERROR_OF_MEAN|1.4||0.817|TWO_SIDED|95.0|-3.11|2.46|||MMRM|||Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||2.46|-3.11|0.8170
72523078|NCT02861118|144576708|OTHER|||||||0.006|||||||Regression, Logistic|||Corticosteroids||||0.006
72523079|NCT02861118|144576708|OTHER|||||||0.006|||||||Regression, Logistic|||Chronic Obstructive Pulmonary Disease||||0.006
72523080|NCT02861118|144576709|OTHER|||||||0.044|||||||Regression, Logistic|||IBD||||0.044
72523081|NCT02861118|144576709|OTHER|||||||0.003|||||||Regression, Logistic|||Corticosteroids||||0.003
72523082|NCT02861118|144576709|OTHER|||||||0.003|||||||Regression, Logistic|||Myocardial Infarction||||0.003
72523083|NCT02861118|144576710|OTHER|||||||0.007|||||||Regression, Logistic|||Corticosteroids||||0.007
72523084|NCT02861118|144576711|OTHER|||||||0.002|||||||Regression, Logistic|||Corticosteroids||||0.002
72523085|NCT02861118|144576711|OTHER|||||||0.003|||||||Regression, Logistic|||Skin Disease||||0.003
72523086|NCT00565812|144576736|SUPERIORITY_OR_OTHER||Difference in Slopes|0.012|STANDARD_ERROR_OF_MEAN|0.018||0.50877|TWO_SIDED|95.0|-0.023|0.046|||Mixed Models Analysis|||Slopes, 95 percent confidence interval (CI), P-values: Random coefficients mixed-effects model for repeated measures (MMRM) with random intercept and slope for each participant,fixed effects for treatment group,time (years),treatment group\*time interaction,(collapsed)Kellgren and Lawrence Grades (KLG), KLG\*time interaction,geographic region,gender,age,body mass index with unstructured covariance matrix for random effects. Statistical hypothesis used Hochberg procedure with 2-sided alpha =0.0499.||0.046|-0.023|0.508770
72523087|NCT00565812|144576736|SUPERIORITY_OR_OTHER||Difference in Slopes|0.005|STANDARD_ERROR_OF_MEAN|0.017||0.754074|TWO_SIDED|95.0|-0.029|0.04|||Mixed Models Analysis|||Slopes, 95 percent CI, P-values: MMRM with random intercept and slope for each participant, fixed effects for treatment group, time (years), treatment group\*time interaction, (collapsed) KLG, KLG\*time interaction, geographic region, gender, age, body mass index with unstructured covariance matrix for random effects. Statistical hypothesis used Hochberg procedure with 2-sided alpha=0.0499.||0.040|-0.029|0.754074
72570545|NCT02504671|144670139|OTHER||Mean Difference (Net)|-8.44||||0.004|TWO_SIDED|95.0|-14.2|-2.67||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4,SDAI|||-2.67|-14.20|0.004
72523088|NCT00565812|144576737|SUPERIORITY_OR_OTHER||Difference in slopes|0.023|STANDARD_ERROR_OF_MEAN|0.023||0.312|TWO_SIDED|95.0|-0.022|0.067|||Mixed Models Analysis|||Slopes, 95 percent CI and P-values were obtained from a random coefficients MMRM with random intercept and slope for each participant, and fixed effects for treatment group, time (years), a treatment group\*time (years) interaction, geographic region, gender, age, and body mass index with an unstructured covariance matrix for the random effects.||0.067|-0.022|0.312
72406322|NCT02942017|144321619|SUPERIORITY||Odds Ratio (OR)|2.9||||0.0168|TWO_SIDED|95.0|1.2|6.7|||GEE method|||Hour 60: Generalized estimating equation (GEE) method was used for analysis. The HAM-D response at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model.||6.7|1.2|0.0168
72523089|NCT00565812|144576737|SUPERIORITY_OR_OTHER||Difference in slopes|0.022|STANDARD_ERROR_OF_MEAN|0.023||0.327|TWO_SIDED|95.0|-0.022|0.067|||Mixed Models Analysis|||Slopes, 95 percent CI and P-values were obtained from a random coefficients MMRM with random intercept and slope for each participant, and fixed effects for treatment group, time (years), a treatment group\*time (years) interaction, geographic region, gender, age, and body mass index with an unstructured covariance matrix for the random effects.||0.067|-0.022|0.327
72523090|NCT00565812|144576738|SUPERIORITY_OR_OTHER||Difference in slopes|0.004|STANDARD_ERROR_OF_MEAN|0.026||0.881|TWO_SIDED|95.0|-0.046|0.054|||Mixed Models Analysis|||Slopes, 95 percent CI and P-values were obtained from a random coefficients MMRM with random intercept and slope for each participant, and fixed effects for treatment group, time (years), a treatment group\*time (years) interaction, geographic region, gender, age, and body mass index with an unstructured covariance matrix for the random effects.||0.054|-0.046|0.881
72523091|NCT00565812|144576738|SUPERIORITY_OR_OTHER||Difference in slopes|-0.007|STANDARD_ERROR_OF_MEAN|0.025||0.78|TWO_SIDED|95.0|-0.056|0.042|||Mixed Models Analysis|||Slopes, 95 percent CI and P-values were obtained from a random coefficients MMRM with random intercept and slope for each participant, and fixed effects for treatment group, time (years), a treatment group\*time (years) interaction, geographic region, gender, age, and body mass index with an unstructured covariance matrix for the random effects.||0.042|-0.056|0.780
72523092|NCT00565812|144576739|SUPERIORITY_OR_OTHER||LS mean difference|0.4|STANDARD_ERROR_OF_MEAN|0.84||0.639|TWO_SIDED|95.0|-1.26|2.05|||Mixed Models Analysis|||Month 3; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value,geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.05|-1.26|0.639
72523093|NCT00565812|144576739|SUPERIORITY_OR_OTHER||LS mean difference|0.05|STANDARD_ERROR_OF_MEAN|0.84||0.957|TWO_SIDED|95.0|-1.61|1.7|||Mixed Models Analysis|||Month 3; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.70|-1.61|0.957
72523094|NCT00565812|144576739|SUPERIORITY_OR_OTHER||LS mean difference|0.13|STANDARD_ERROR_OF_MEAN|0.96||0.893|TWO_SIDED|95.0|-1.76|2.01|||Mixed Models Analysis|||Month 6; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value,geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.01|-1.76|0.893
72523095|NCT00565812|144576739|SUPERIORITY_OR_OTHER||LS mean difference|0.87|STANDARD_ERROR_OF_MEAN|0.96||0.365|TWO_SIDED|95.0|-1.01|2.76|||Mixed Models Analysis|||Month 6; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value,geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.76|-1.01|0.365
72523096|NCT00565812|144576739|SUPERIORITY_OR_OTHER||LS mean difference|0.44|STANDARD_ERROR_OF_MEAN|1.05||0.678|TWO_SIDED|95.0|-1.63|2.51|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit,a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value,geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.51|-1.63|0.678
72523097|NCT00565812|144576739|SUPERIORITY_OR_OTHER||LS mean difference|-0.13|STANDARD_ERROR_OF_MEAN|1.05||0.902|TWO_SIDED|95.0|-2.18|1.93|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit,a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value,geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.93|-2.18|0.902
72523098|NCT00565812|144576739|SUPERIORITY_OR_OTHER||LS mean difference|-0.64|STANDARD_ERROR_OF_MEAN|1.15||0.577|TWO_SIDED|95.0|-2.89|1.61|||Mixed Models Analysis|||Month 18; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit,a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value,geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.61|-2.89|0.577
72523099|NCT00565812|144576739|SUPERIORITY_OR_OTHER||LS mean difference|-0.03|STANDARD_ERROR_OF_MEAN|1.14||0.98|TWO_SIDED|95.0|-2.26|2.21|||Mixed Models Analysis|||Month 18; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit,a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value,geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.21|-2.26|0.980
72406323|NCT02942017|144321619|SUPERIORITY||Odds Ratio (OR)|2.6||||0.0482|TWO_SIDED|95.0|1.0|6.6|||GEE method|||Day 7: GEE method was used for analysis. The HAM-D response at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model.||6.6|1.0|0.0482
72570546|NCT02504671|144670139|OTHER||Mean Difference (Net)|-12.51|||<|0.001|TWO_SIDED|95.0|-18.26|-6.75||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4,SDAI|||-6.75|-18.26|<0.001
72523100|NCT00565812|144576739|SUPERIORITY_OR_OTHER||LS mean difference|-0.07|STANDARD_ERROR_OF_MEAN|1.17||0.95|TWO_SIDED|95.0|-2.37|2.23|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit,a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value,geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.23|-2.37|0.950
72523101|NCT00565812|144576739|SUPERIORITY_OR_OTHER||LS mean difference|-1.23|STANDARD_ERROR_OF_MEAN|1.17||0.292|TWO_SIDED|95.0|-3.53|1.06|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit,a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value,geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.06|-3.53|0.292
72570547|NCT02504671|144670139|OTHER||Mean Difference (Net)|-7.0||||0.022|TWO_SIDED|95.0|-12.99|-1.01||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 6,SDAI|||-1.01|-12.99|0.022
72406324|NCT02942017|144321619|SUPERIORITY||Odds Ratio (OR)|0.8||||0.5857|TWO_SIDED|95.0|0.3|2.0|||GEE method|||Day 30: GEE method was used for analysis. The HAM-D response at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. An exchangeable working correlation structure is assumed for the model parameters estimation.||2.0|0.3|0.5857
72406325|NCT02942017|144321620|SUPERIORITY||Odds Ratio (OR)|3.4||||0.0033|TWO_SIDED|95.0|1.5|7.9||Hour 60:|GEE method|||Hour 60: GEE method was used for analysis. The HAM-D remission at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model.||7.9|1.5|0.0033
72406326|NCT02942017|144321620|SUPERIORITY||Odds Ratio (OR)|3.7||||0.0046|TWO_SIDED|95.0|1.5|9.3|||GEE method|||Day 7: GEE method was used for analysis. The HAM-D remission at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model.||9.3|1.5|0.0046
72523102|NCT00565812|144576740|SUPERIORITY_OR_OTHER||LS mean difference|0.08|STANDARD_ERROR_OF_MEAN|0.19||0.683|TWO_SIDED|95.0|-0.3|0.46|||Mixed Models Analysis|||Month 3; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit,a treatment group\* visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value,geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.46|-0.30|0.683
72523103|NCT00565812|144576740|SUPERIORITY_OR_OTHER||LS mean difference|-0.04|STANDARD_ERROR_OF_MEAN|0.19||0.853|TWO_SIDED|95.0|-0.42|0.35|||Mixed Models Analysis|||Month 3; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit,a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value,geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.35|-0.42|0.853
72523104|NCT00565812|144576740|SUPERIORITY_OR_OTHER||LS mean difference|0.02|STANDARD_ERROR_OF_MEAN|0.22||0.938|TWO_SIDED|95.0|-0.41|0.44|||Mixed Models Analysis|||Month 6; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit,a treatment group\* visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value,geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.44|-0.41|0.938
72523105|NCT00565812|144576740|SUPERIORITY_OR_OTHER||LS mean difference|0.1|STANDARD_ERROR_OF_MEAN|0.22||0.648|TWO_SIDED|95.0|-0.32|0.52|||Mixed Models Analysis|||Month 6; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit,a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value,geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.52|-0.32|0.648
72523106|NCT00565812|144576740|SUPERIORITY_OR_OTHER||LS mean difference|-0.02|STANDARD_ERROR_OF_MEAN|0.24||0.916|TWO_SIDED|95.0|-0.49|0.44|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit,a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value,geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.44|-0.49|0.916
72523107|NCT00565812|144576740|SUPERIORITY_OR_OTHER||LS mean difference|-0.15|STANDARD_ERROR_OF_MEAN|0.23||0.528|TWO_SIDED|95.0|-0.6|0.31|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit,a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value,geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.31|-0.60|0.528
72523108|NCT00565812|144576740|SUPERIORITY_OR_OTHER||LS mean difference|-0.23|STANDARD_ERROR_OF_MEAN|0.25||0.365|TWO_SIDED|95.0|-0.73|0.27|||Mixed Models Analysis|||Month 18; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.27|-0.73|0.365
72570548|NCT02504671|144670139|OTHER||Mean Difference (Net)|-10.16|||<|0.001|TWO_SIDED|95.0|-16.07|-4.24||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 6,SDAI|||-4.24|-16.07|<0.001
72570549|NCT02504671|144670139|OTHER||Mean Difference (Net)|-11.18|||<|0.001|TWO_SIDED|95.0|-17.7|-4.66||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 8,SDAI|||-4.66|-17.70|<0.001
72570550|NCT02504671|144670139|OTHER||Mean Difference (Net)|-14.0|||<|0.001|TWO_SIDED|95.0|-20.57|-7.44||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 8,SDAI|||-7.44|-20.57|<0.001
72570551|NCT02504671|144670139|OTHER||Mean Difference (Net)|-9.68||||0.013|TWO_SIDED|95.0|-17.26|-2.11||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12,SDAI|||-2.11|-17.26|0.013
72523109|NCT00565812|144576740|SUPERIORITY_OR_OTHER||LS mean difference|-0.25|STANDARD_ERROR_OF_MEAN|0.25||0.328|TWO_SIDED|95.0|-0.74|0.25|||Mixed Models Analysis|||Month 18; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit,a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value,geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.25|-0.74|0.328
72523110|NCT00565812|144576740|SUPERIORITY_OR_OTHER||LS mean difference|-0.16|STANDARD_ERROR_OF_MEAN|0.26||0.54|TWO_SIDED|95.0|-0.66|0.35|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit,a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value,geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.35|-0.66|0.540
72523111|NCT00565812|144576740|SUPERIORITY_OR_OTHER||LS mean difference|-0.21|STANDARD_ERROR_OF_MEAN|0.26||0.423|TWO_SIDED|95.0|-0.71|0.3|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit,a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value,geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.30|-0.71|0.423
72523112|NCT00565812|144576741|SUPERIORITY_OR_OTHER||LS mean difference|0.01|STANDARD_ERROR_OF_MEAN|0.09||0.904|TWO_SIDED|95.0|-0.17|0.2|||Mixed Models Analysis|||Month 3; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.20|-0.17|0.904
72523113|NCT00565812|144576741|SUPERIORITY_OR_OTHER||LS mean difference|-0.05|STANDARD_ERROR_OF_MEAN|0.09||0.582|TWO_SIDED|95.0|-0.24|0.13|||Mixed Models Analysis|||Month 3; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.13|-0.24|0.582
72523114|NCT00565812|144576741|SUPERIORITY_OR_OTHER||LS mean difference|-0.02|STANDARD_ERROR_OF_MEAN|0.1||0.818|TWO_SIDED|95.0|-0.22|0.18|||Mixed Models Analysis|||Month 6; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.18|-0.22|0.818
72523115|NCT00565812|144576741|SUPERIORITY_OR_OTHER||LS mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.1||0.988|TWO_SIDED|95.0|-0.2|0.2|||Mixed Models Analysis|||Month 6; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit,a treatment group x visit interaction, (collapsed) KLG, a (collapsed) KLG x visit interaction, baseline value,geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.20|-0.20|0.988
72523116|NCT00565812|144576741|SUPERIORITY_OR_OTHER||LS mean difference|0.02|STANDARD_ERROR_OF_MEAN|0.11||0.857|TWO_SIDED|95.0|-0.2|0.24|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value,geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.24|-0.20|0.857
72523117|NCT00565812|144576741|SUPERIORITY_OR_OTHER||LS mean difference|0.05|STANDARD_ERROR_OF_MEAN|0.11||0.658|TWO_SIDED|95.0|-0.17|0.27|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.27|-0.17|0.658
72523118|NCT00565812|144576741|SUPERIORITY_OR_OTHER||LS mean difference|-0.06|STANDARD_ERROR_OF_MEAN|0.12||0.612|TWO_SIDED|95.0|-0.28|0.17|||Mixed Models Analysis|||Month 18; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.17|-0.28|0.612
72523119|NCT00565812|144576741|SUPERIORITY_OR_OTHER||LS mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.11||0.391|TWO_SIDED|95.0|-0.32|0.13|||Mixed Models Analysis|||Month 18; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.13|-0.32|0.391
72523120|NCT00565812|144576741|SUPERIORITY_OR_OTHER||LS mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.12||1|TWO_SIDED|95.0|-0.24|0.24|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value,geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.24|-0.24|1.000
72523121|NCT00565812|144576741|SUPERIORITY_OR_OTHER||LS mean difference|-0.21|STANDARD_ERROR_OF_MEAN|0.12||0.086|TWO_SIDED|95.0|-0.45|0.03|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.03|-0.45|0.086
72523122|NCT00565812|144576742|SUPERIORITY_OR_OTHER||LS mean difference|0.34|STANDARD_ERROR_OF_MEAN|0.62||0.586|TWO_SIDED|95.0|-0.88|1.55|||Mixed Models Analysis|||Month 3; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.55|-0.88|0.586
72406327|NCT02942017|144321620|SUPERIORITY||Odds Ratio (OR)|0.6||||0.3085|TWO_SIDED|95.0|0.3|1.5|||GEE method|||Day 30: GEE method was used for analysis. The HAM-D remission at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model.||1.5|0.3|0.3085
72523123|NCT00565812|144576742|SUPERIORITY_OR_OTHER||LS mean difference|0.17|STANDARD_ERROR_OF_MEAN|0.62||0.789|TWO_SIDED|95.0|-1.05|1.38|||Mixed Models Analysis|||Month 3; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.38|-1.05|0.789
72523124|NCT00565812|144576742|SUPERIORITY_OR_OTHER||LS mean difference|0.16|STANDARD_ERROR_OF_MEAN|0.69||0.821|TWO_SIDED|95.0|-1.21|1.52|||Mixed Models Analysis|||Month 6; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.52|-1.21|0.821
72523125|NCT00565812|144576742|SUPERIORITY_OR_OTHER||LS mean difference|0.73|STANDARD_ERROR_OF_MEAN|0.69||0.294|TWO_SIDED|95.0|-0.63|2.09|||Mixed Models Analysis|||Month 6; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.09|-0.63|0.294
72523126|NCT00565812|144576742|SUPERIORITY_OR_OTHER||LS mean difference|0.48|STANDARD_ERROR_OF_MEAN|0.76||0.532|TWO_SIDED|95.0|-1.02|1.97|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.97|-1.02|0.532
72523127|NCT00565812|144576742|SUPERIORITY_OR_OTHER||LS mean difference|-0.06|STANDARD_ERROR_OF_MEAN|0.76||0.938|TWO_SIDED|95.0|-1.55|1.43|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.43|-1.55|0.938
72523128|NCT00565812|144576742|SUPERIORITY_OR_OTHER||LS mean difference|-0.34|STANDARD_ERROR_OF_MEAN|0.83||0.68|TWO_SIDED|95.0|-1.97|1.29|||Mixed Models Analysis|||Month 18; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.29|-1.97|0.680
72523129|NCT00565812|144576742|SUPERIORITY_OR_OTHER||LS mean difference|0.28|STANDARD_ERROR_OF_MEAN|0.82||0.73|TWO_SIDED|95.0|-1.33|1.9|||Mixed Models Analysis|||Month 18; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.90|-1.33|0.730
72523130|NCT00565812|144576742|SUPERIORITY_OR_OTHER||LS mean difference|0.1|STANDARD_ERROR_OF_MEAN|0.84||0.901|TWO_SIDED|95.0|-1.55|1.76|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.76|-1.55|0.901
72523131|NCT00565812|144576742|SUPERIORITY_OR_OTHER||LS mean difference|-0.81|STANDARD_ERROR_OF_MEAN|0.84||0.333|TWO_SIDED|95.0|-2.45|0.83|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.83|-2.45|0.333
72523132|NCT00565812|144576743|SUPERIORITY_OR_OTHER||LS mean difference|2.34|STANDARD_ERROR_OF_MEAN|1.36||0.086|TWO_SIDED|95.0|-0.33|5.01|||Mixed Models Analysis|||Month 3; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||5.01|-0.33|0.086
72523133|NCT00565812|144576743|SUPERIORITY_OR_OTHER||LS mean difference|1.11|STANDARD_ERROR_OF_MEAN|1.36||0.415|TWO_SIDED|95.0|-1.56|3.78|||Mixed Models Analysis|||Month 3; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||3.78|-1.56|0.415
72523134|NCT00565812|144576743|SUPERIORITY_OR_OTHER||LS mean difference|0.8|STANDARD_ERROR_OF_MEAN|1.41||0.569|TWO_SIDED|95.0|-1.97|3.57|||Mixed Models Analysis|||Month 6; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||3.57|-1.97|0.569
72523135|NCT00565812|144576743|SUPERIORITY_OR_OTHER||LS mean difference|1.26|STANDARD_ERROR_OF_MEAN|1.41||0.374|TWO_SIDED|95.0|-1.51|4.02|||Mixed Models Analysis|||Month 6; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||4.02|-1.51|0.374
72570552|NCT02504671|144670139|OTHER||Mean Difference (Net)|-16.86|||<|0.001|TWO_SIDED|95.0|-24.39|-9.32||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12,SDAI|||-9.32|-24.39|<0.001
72570553|NCT02504671|144670139|OTHER||Mean Difference (Net)|-6.03||||0.149|TWO_SIDED|95.0|-14.24|2.18||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 16,SDAI|||2.18|-14.24|0.149
72406328|NCT02942017|144321621|SUPERIORITY||LS mean difference|-8.35|STANDARD_ERROR_OF_MEAN|2.989||0.0063|TWO_SIDED|95.0|-14.29|-2.42|||MMRM|||Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D subscales at each visit was the dependent variable. Treatment, baseline HAM-D subscales, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model. All explanatory variables including pooled center were treated as fixed effects.||-2.42|-14.29|0.0063
72406329|NCT02942017|144321621|SUPERIORITY||LS mean difference|-9.75|STANDARD_ERROR_OF_MEAN|3.566||0.0074|TWO_SIDED|95.0|-16.83|-2.68|||MMRM|||Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D subscales at each visit was the dependent variable. Treatment, baseline HAM-D subscales, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model. All explanatory variables including pooled center were treated as fixed effects.||-2.68|-16.83|0.0074
72523136|NCT00565812|144576743|SUPERIORITY_OR_OTHER||LS mean difference|1.63|STANDARD_ERROR_OF_MEAN|1.53||0.288|TWO_SIDED|95.0|-1.38|4.64|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||4.64|-1.38|0.288
72523137|NCT00565812|144576743|SUPERIORITY_OR_OTHER||LS mean difference|1.18|STANDARD_ERROR_OF_MEAN|1.52||0.44|TWO_SIDED|95.0|-1.81|4.17|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||4.17|-1.81|0.440
72523138|NCT00565812|144576743|SUPERIORITY_OR_OTHER||LS mean difference|-0.21|STANDARD_ERROR_OF_MEAN|1.58||0.896|TWO_SIDED|95.0|-3.3|2.88|||Mixed Models Analysis|||Month 18; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.88|-3.30|0.896
72523139|NCT00565812|144576743|SUPERIORITY_OR_OTHER||LS mean difference|1.14|STANDARD_ERROR_OF_MEAN|1.56||0.464|TWO_SIDED|95.0|-1.92|4.2|||Mixed Models Analysis|||Month 18; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||4.20|-1.92|0.464
72523140|NCT00565812|144576743|SUPERIORITY_OR_OTHER||LS mean difference|-0.2|STANDARD_ERROR_OF_MEAN|1.57||0.901|TWO_SIDED|95.0|-3.27|2.88|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.88|-3.27|0.901
72523141|NCT00565812|144576743|SUPERIORITY_OR_OTHER||LS mean difference|-0.39|STANDARD_ERROR_OF_MEAN|1.56||0.8|TWO_SIDED|95.0|-3.45|2.66|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value,geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.66|-3.45|0.800
72523142|NCT00565812|144576744|SUPERIORITY_OR_OTHER||LS mean difference|0.001|STANDARD_ERROR_OF_MEAN|0.048||0.984|TWO_SIDED|95.0|-0.093|0.095|||Mixed Models Analysis|||Month 3; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.095|-0.093|0.984
72523143|NCT00565812|144576744|SUPERIORITY_OR_OTHER||LS mean difference|-0.046|STANDARD_ERROR_OF_MEAN|0.048||0.33|TWO_SIDED|95.0|-0.14|0.047|||Mixed Models Analysis|||Month 3; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.047|-0.140|0.330
72523144|NCT00565812|144576744|SUPERIORITY_OR_OTHER||LS mean difference|-0.05|STANDARD_ERROR_OF_MEAN|0.049||0.308|TWO_SIDED|95.0|-0.146|0.046|||Mixed Models Analysis|||Month 6; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.046|-0.146|0.308
72523145|NCT00565812|144576744|SUPERIORITY_OR_OTHER||LS mean difference|-0.083|STANDARD_ERROR_OF_MEAN|0.049||0.089|TWO_SIDED|95.0|-0.18|0.013|||Mixed Models Analysis|||Month 6; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.013|-0.180|0.089
72523146|NCT00565812|144576744|SUPERIORITY_OR_OTHER||LS mean difference|-0.035|STANDARD_ERROR_OF_MEAN|0.052||0.508|TWO_SIDED|95.0|-0.137|0.068|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.068|-0.137|0.508
72523147|NCT00565812|144576744|SUPERIORITY_OR_OTHER||LS mean difference|-0.036|STANDARD_ERROR_OF_MEAN|0.052||0.49|TWO_SIDED|95.0|-0.137|0.066|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.066|-0.137|0.490
72570554|NCT02504671|144670139|OTHER||Mean Difference (Net)|-9.43||||0.019|TWO_SIDED|95.0|-17.32|-1.55||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 16,SDAI|||-1.55|-17.32|0.019
72570555|NCT02504671|144670139|OTHER||Mean Difference (Net)|-6.59||||0.138|TWO_SIDED|95.0|-15.32|2.14||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 20,SDAI|||2.14|-15.32|0.138
72570556|NCT02504671|144670139|OTHER||Mean Difference (Net)|-8.7||||0.04|TWO_SIDED|95.0|-16.99|-0.42||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 20,SDAI|||-0.42|-16.99|0.040
72570557|NCT02504671|144670139|OTHER||Mean Difference (Net)|-15.88||||0.005|TWO_SIDED|95.0|-26.77|-4.98||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24,SDAI|||-4.98|-26.77|0.005
72570558|NCT02504671|144670139|OTHER||Mean Difference (Net)|-20.87|||<|0.001|TWO_SIDED|95.0|-31.2|-10.53||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24,SDAI|||-10.53|-31.20|<0.001
72570559|NCT02504671|144670140|OTHER||Mean Difference (Net)|-3.84||||0.063|TWO_SIDED|95.0|-7.89|0.2||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 1,CDAI|||0.20|-7.89|0.063
72570560|NCT02504671|144670140|OTHER||Mean Difference (Net)|-3.84||||0.067|TWO_SIDED|95.0|-7.95|0.28||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 1,CDAI|||0.28|-7.95|0.067
72570561|NCT02504671|144670140|OTHER||Mean Difference (Net)|-4.43||||0.032|TWO_SIDED|95.0|-8.46|-0.39||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 1,CDAI|||-0.39|-8.46|0.032
72570562|NCT02504671|144670140|OTHER||Mean Difference (Net)|-4.17||||0.102|TWO_SIDED|95.0|-9.17|0.84||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 2,CDAI|||0.84|-9.17|0.102
72406330|NCT02942017|144321621|SUPERIORITY||LS mean difference|1.37|STANDARD_ERROR_OF_MEAN|3.149||0.6637|TWO_SIDED|95.0|-4.88|7.63|||MMRM|||Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D subscales at each visit was the dependent variable. Treatment, baseline HAM-D subscales, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model. All explanatory variables including pooled center were treated as fixed effects.||7.63|-4.88|0.6637
72570563|NCT02504671|144670140|OTHER||Mean Difference (Net)|-3.47||||0.17|TWO_SIDED|95.0|-8.43|1.49||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 2,CDAI|||1.49|-8.43|0.170
72570564|NCT02504671|144670140|OTHER||Mean Difference (Net)|-5.2||||0.039|TWO_SIDED|95.0|-10.13|-0.27||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 2,CDAI|||-0.27|-10.13|0.039
72570565|NCT02504671|144670140|OTHER||Mean Difference (Net)|-7.2||||0.012|TWO_SIDED|95.0|-12.82|-1.57||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4,CDAI|||-1.57|-12.82|0.012
72570566|NCT02504671|144670140|OTHER||Mean Difference (Net)|-6.73||||0.018|TWO_SIDED|95.0|-12.3|-1.16||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4,CDAI|||-1.16|-12.30|0.018
72570567|NCT02504671|144670140|OTHER||Mean Difference (Net)|-9.19||||0.001|TWO_SIDED|95.0|-14.73|-3.66||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4,CDAI|||-3.66|-14.73|0.001
72570568|NCT02504671|144670140|OTHER||Mean Difference (Net)|-5.48||||0.065|TWO_SIDED|95.0|-11.31|0.35||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 6,CDAI|||0.35|-11.31|0.065
72570569|NCT02504671|144670140|OTHER||Mean Difference (Net)|-5.85||||0.05|TWO_SIDED|95.0|-11.69|0.0||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 6,CDAI|||-0.00|-11.69|0.050
72570570|NCT02504671|144670140|OTHER||Mean Difference (Final Values)|-6.63||||0.024|TWO_SIDED|95.0|-12.38|-0.87||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 6,CDAI|||-0.87|-12.38|0.024
72570571|NCT02504671|144670140|OTHER||Mean Difference (Net)|-6.41||||0.051|TWO_SIDED|95.0|-12.84|0.02||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 8,CDAI|||0.02|-12.84|0.051
72570572|NCT02504671|144670140|OTHER||Mean Difference (Net)|-8.6||||0.008|TWO_SIDED|95.0|-14.97|-2.22||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 8,CDAI|||-2.22|-14.97|0.008
72570573|NCT02504671|144670140|OTHER||Mean Difference (Net)|-8.74||||0.007|TWO_SIDED|95.0|-15.06|-2.43||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 8,CDAI|||-2.43|-15.06|0.007
72570574|NCT02504671|144670140|OTHER||Mean Difference (Net)|-6.8||||0.071|TWO_SIDED|95.0|-14.19|0.58||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12,CDAI|||0.58|-14.19|0.071
72570575|NCT02504671|144670140|OTHER||Mean Difference (Net)|-9.8||||0.009|TWO_SIDED|95.0|-17.17|-2.44||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12,CDAI|||-2.44|-17.17|0.009
72570576|NCT02504671|144670140|OTHER||Mean Difference (Net)|-13.88|||<|0.001|TWO_SIDED|95.0|-21.17|-6.59||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12,CDAI|||-6.59|-21.17|<0.001
72570577|NCT02504671|144670140|OTHER||Mean Difference (Net)|-1.68||||0.676|TWO_SIDED|95.0|-9.63|6.26||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 16,CDAI|||6.26|-9.63|0.676
72570578|NCT02504671|144670140|OTHER||Mean Difference (Net)|-6.33||||0.11|TWO_SIDED|95.0|-14.11|1.44||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 16,CDAI|||1.44|-14.11|0.110
72523148|NCT00565812|144576744|SUPERIORITY_OR_OTHER||LS mean difference|-0.019|STANDARD_ERROR_OF_MEAN|0.057||0.739|TWO_SIDED|95.0|-0.132|0.094|||Mixed Models Analysis|||Month 18; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.094|-0.132|0.739
72523149|NCT00565812|144576744|SUPERIORITY_OR_OTHER||LS mean difference|-0.05|STANDARD_ERROR_OF_MEAN|0.057||0.376|TWO_SIDED|95.0|-0.162|0.061|||Mixed Models Analysis|||Month 18; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.061|-0.162|0.376
72523150|NCT00565812|144576744|SUPERIORITY_OR_OTHER||LS mean difference|-0.008|STANDARD_ERROR_OF_MEAN|0.057||0.883|TWO_SIDED|95.0|-0.121|0.104|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.104|-0.121|0.883
72523151|NCT00565812|144576744|SUPERIORITY_OR_OTHER||LS mean difference|-0.023|STANDARD_ERROR_OF_MEAN|0.057||0.69|TWO_SIDED|95.0|-0.135|0.089|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.089|-0.135|0.690
72523152|NCT00565812|144576745|SUPERIORITY_OR_OTHER||LS mean difference|0.008|STANDARD_ERROR_OF_MEAN|0.044||0.849|TWO_SIDED|95.0|-0.078|0.095|||Mixed Models Analysis|||Month 3; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.095|-0.078|0.849
72523153|NCT00565812|144576745|SUPERIORITY_OR_OTHER||LS mean difference|-0.009|STANDARD_ERROR_OF_MEAN|0.044||0.837|TWO_SIDED|95.0|-0.096|0.078|||Mixed Models Analysis|||Month 3; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.078|-0.096|0.837
72523154|NCT00565812|144576745|SUPERIORITY_OR_OTHER||LS mean difference|-0.013|STANDARD_ERROR_OF_MEAN|0.047||0.776|TWO_SIDED|95.0|-0.105|0.078|||Mixed Models Analysis|||Month 6; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.078|-0.105|0.776
72523155|NCT00565812|144576745|SUPERIORITY_OR_OTHER||LS mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.047||0.033|TWO_SIDED|95.0|-0.191|-0.008|||Mixed Models Analysis|||Month 6; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||-0.008|-0.191|0.033
72523156|NCT00565812|144576745|SUPERIORITY_OR_OTHER||LS mean difference|-0.064|STANDARD_ERROR_OF_MEAN|0.05||0.201|TWO_SIDED|95.0|-0.163|0.034|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.034|-0.163|0.201
72523157|NCT00565812|144576745|SUPERIORITY_OR_OTHER||LS mean difference|-0.103|STANDARD_ERROR_OF_MEAN|0.05||0.038|TWO_SIDED|95.0|-0.201|-0.006|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||-0.006|-0.201|0.038
72523158|NCT00565812|144576745|SUPERIORITY_OR_OTHER||LS mean difference|-0.01|STANDARD_ERROR_OF_MEAN|0.053||0.848|TWO_SIDED|95.0|-0.114|0.094|||Mixed Models Analysis|||Month 18; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.094|-0.114|0.848
72523159|NCT00565812|144576745|SUPERIORITY_OR_OTHER||LS mean difference|-0.019|STANDARD_ERROR_OF_MEAN|0.052||0.714|TWO_SIDED|95.0|-0.122|0.084|||Mixed Models Analysis|||Month 18; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.084|-0.122|0.714
72523160|NCT00565812|144576745|SUPERIORITY_OR_OTHER||LS mean difference|0.025|STANDARD_ERROR_OF_MEAN|0.054||0.652|TWO_SIDED|95.0|-0.082|0.131|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.131|-0.082|0.652
72523161|NCT00565812|144576745|SUPERIORITY_OR_OTHER||LS mean difference|0.021|STANDARD_ERROR_OF_MEAN|0.054||0.7|TWO_SIDED|95.0|-0.085|0.127|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.127|-0.085|0.700
72523162|NCT00565812|144576746|SUPERIORITY_OR_OTHER||LS mean difference|1.68|STANDARD_ERROR_OF_MEAN|1.37||0.22|TWO_SIDED|95.0|-1.0|4.36|||Mixed Models Analysis|||Month 3; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||4.36|-1.00|0.220
72523163|NCT00565812|144576746|SUPERIORITY_OR_OTHER||LS mean difference|0.01|STANDARD_ERROR_OF_MEAN|1.36||0.997|TWO_SIDED|95.0|-2.67|2.68|||Mixed Models Analysis|||Month 3; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.68|-2.67|0.997
72523164|NCT00565812|144576746|SUPERIORITY_OR_OTHER||LS mean difference|0.73|STANDARD_ERROR_OF_MEAN|1.44||0.613|TWO_SIDED|95.0|-2.09|3.55|||Mixed Models Analysis|||Month 6; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||3.55|-2.09|0.613
72523165|NCT00565812|144576746|SUPERIORITY_OR_OTHER||LS mean difference|0.06|STANDARD_ERROR_OF_MEAN|1.44||0.964|TWO_SIDED|95.0|-2.75|2.88|||Mixed Models Analysis|||Month 6; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.88|-2.75|0.964
72523166|NCT00565812|144576746|SUPERIORITY_OR_OTHER||LS mean difference|0.24|STANDARD_ERROR_OF_MEAN|1.49||0.872|TWO_SIDED|95.0|-2.69|3.17|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||3.17|-2.69|0.872
72523167|NCT00565812|144576746|SUPERIORITY_OR_OTHER||LS mean difference|0.1|STANDARD_ERROR_OF_MEAN|1.48||0.947|TWO_SIDED|95.0|-2.81|3.01|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||3.01|-2.81|0.947
72523168|NCT00565812|144576746|SUPERIORITY_OR_OTHER||LS mean difference|0.15|STANDARD_ERROR_OF_MEAN|1.62||0.927|TWO_SIDED|95.0|-3.03|3.33|||Mixed Models Analysis|||Month 18; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||3.33|-3.03|0.927
72523169|NCT00565812|144576746|SUPERIORITY_OR_OTHER||LS mean difference|0.97|STANDARD_ERROR_OF_MEAN|1.61||0.547|TWO_SIDED|95.0|-2.18|4.12|||Mixed Models Analysis|||Month 18; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||4.12|-2.18|0.547
72523170|NCT00565812|144576746|SUPERIORITY_OR_OTHER||LS mean difference|1.62|STANDARD_ERROR_OF_MEAN|1.58||0.304|TWO_SIDED|95.0|-1.47|4.71|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||4.71|-1.47|0.304
72523171|NCT00565812|144576746|SUPERIORITY_OR_OTHER||LS mean difference|-0.65|STANDARD_ERROR_OF_MEAN|1.57||0.679|TWO_SIDED|95.0|-3.73|2.43|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.43|-3.73|0.679
72523172|NCT00565812|144576747|SUPERIORITY_OR_OTHER||LS mean difference|0.37|STANDARD_ERROR_OF_MEAN|1.11||0.738|TWO_SIDED|95.0|-1.8|2.55|||Mixed Models Analysis|||Month 3; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.55|-1.80|0.738
72523173|NCT00565812|144576747|SUPERIORITY_OR_OTHER||LS mean difference|-0.53|STANDARD_ERROR_OF_MEAN|1.11||0.632|TWO_SIDED|95.0|-2.7|1.64|||Mixed Models Analysis|||Month 3; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.64|-2.70|0.632
72523174|NCT00565812|144576747|SUPERIORITY_OR_OTHER||LS mean difference|-0.41|STANDARD_ERROR_OF_MEAN|1.21||0.736|TWO_SIDED|95.0|-2.77|1.96|||Mixed Models Analysis|||Month 6; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.96|-2.77|0.736
72570579|NCT02504671|144670140|OTHER||Mean Difference (Net)|-6.44||||0.099|TWO_SIDED|95.0|-14.12|1.23||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 16,CDAI|||1.23|-14.12|0.099
72406331|NCT02942017|144321622|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.154||0.5132|TWO_SIDED|95.0|-0.41|0.21|||MMRM|||Depressed Mood, Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.21|-0.41|0.5132
72406332|NCT02942017|144321622|SUPERIORITY||LS Mean Difference|-0.25|STANDARD_ERROR_OF_MEAN|0.181||0.1672|TWO_SIDED|95.0|-0.61|0.11|||MMRM|||Depressed Mood, Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.11|-0.61|0.1672
72406333|NCT02942017|144321622|SUPERIORITY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.178||0.0963|TWO_SIDED|95.0|-0.65|0.05|||MMRM|||Depressed Mood, Hour 8:MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.05|-0.65|0.0963
72406334|NCT02942017|144321622|SUPERIORITY||LS Mean Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.183||0.4803|TWO_SIDED|95.0|-0.49|0.23|||MMRM|||Depressed Mood, Hour 12:MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.23|-0.49|0.4803
72406335|NCT02942017|144321622|SUPERIORITY||LS Mean Difference|-0.33|STANDARD_ERROR_OF_MEAN|0.191||0.0844|TWO_SIDED|95.0|-0.71|0.05|||MMRM|||Depressed Mood, Hour 24:MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.05|-0.71|0.0844
72523175|NCT00565812|144576747|SUPERIORITY_OR_OTHER||LS mean difference|-0.29|STANDARD_ERROR_OF_MEAN|1.21||0.811|TWO_SIDED|95.0|-2.66|2.08|||Mixed Models Analysis|||Month 6; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.08|-2.66|0.811
72570580|NCT02504671|144670140|OTHER||Mean Difference (Net)|1.04||||0.812|TWO_SIDED|95.0|-7.61|9.69||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 20,CDAI|||9.69|-7.61|0.812
72570581|NCT02504671|144670140|OTHER||Mean Difference (Net)|-5.39||||0.204|TWO_SIDED|95.0|-13.75|2.96||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 20,CDAI|||2.96|-13.75|0.204
72570582|NCT02504671|144670140|OTHER||Mean Difference (Net)|-5.9||||0.157|TWO_SIDED|95.0|-14.09|2.3||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 20,CDAI|||2.30|-14.09|0.157
72570583|NCT02504671|144670140|OTHER||Mean Difference (Net)|-9.37||||0.088|TWO_SIDED|95.0|-20.15|1.42||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24,CDAI|||1.42|-20.15|0.088
72406336|NCT02942017|144321622|SUPERIORITY||LS Mean Difference|-0.29|STANDARD_ERROR_OF_MEAN|0.193||0.1325|TWO_SIDED|95.0|-0.68|0.09|||MMRM|||Depressed Mood, Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.09|-0.68|0.1325
72406337|NCT02942017|144321622|SUPERIORITY||LS Mean Difference|-0.41|STANDARD_ERROR_OF_MEAN|0.192||0.0332|TWO_SIDED|95.0|-0.79|-0.03|||MMRM|||Depressed Mood, Hour 48:MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.03|-0.79|0.0332
72406338|NCT02942017|144321622|SUPERIORITY||LS Mean Difference|-0.29|STANDARD_ERROR_OF_MEAN|0.189||0.1273|TWO_SIDED|95.0|-0.67|0.08|||MMRM|||Depressed Mood, Hour 60:MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.08|-0.67|0.1273
72406339|NCT02942017|144321622|SUPERIORITY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.182||0.1059|TWO_SIDED|95.0|-0.66|0.06|||MMRM|||Depressed Mood, Hour 72:MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.06|-0.66|0.1059
72523176|NCT00565812|144576747|SUPERIORITY_OR_OTHER||LS mean difference|-1.22|STANDARD_ERROR_OF_MEAN|1.27||0.335|TWO_SIDED|95.0|-3.71|1.26|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.26|-3.71|0.335
72570584|NCT02504671|144670140|OTHER||Mean Difference (Net)|-15.12||||0.004|TWO_SIDED|95.0|-25.4|-4.83||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24,CDAI|||-4.83|-25.40|0.004
72570585|NCT02504671|144670140|OTHER||Mean Difference (Net)|-14.91||||0.004|TWO_SIDED|95.0|-25.01|-4.8||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24,CDAI|||-4.80|-25.01|0.004
72570586|NCT02504671|144670140|OTHER||Mean Difference (Net)|-3.89||||0.06|TWO_SIDED|95.0|-7.96|0.17||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 1,CDAI|||0.17|-7.96|0.060
72570587|NCT02504671|144670140|OTHER||Mean Difference (Net)|-7.39|||<|0.001|TWO_SIDED|95.0|-11.42|-3.36||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 1,CDAI|||-3.36|-11.42|<0.001
72523177|NCT00565812|144576747|SUPERIORITY_OR_OTHER||LS mean difference|-0.05|STANDARD_ERROR_OF_MEAN|1.26||0.966|TWO_SIDED|95.0|-2.52|2.41|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.41|-2.52|0.966
72523178|NCT00565812|144576747|SUPERIORITY_OR_OTHER||LS mean difference|-1.44|STANDARD_ERROR_OF_MEAN|1.38||0.299|TWO_SIDED|95.0|-4.16|1.28|||Mixed Models Analysis|||Month 18; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.28|-4.16|0.299
72523179|NCT00565812|144576747|SUPERIORITY_OR_OTHER||LS mean difference|0.13|STANDARD_ERROR_OF_MEAN|1.37||0.925|TWO_SIDED|95.0|-2.56|2.82|||Mixed Models Analysis|||Month 18; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.82|-2.56|0.925
72570588|NCT02504671|144670140|OTHER||Mean Difference (Net)|-6.1||||0.016|TWO_SIDED|95.0|-11.06|-1.14||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 2,CDAI|||-1.14|-11.06|0.016
72570589|NCT02504671|144670140|OTHER||Mean Difference (Net)|-6.85||||0.007|TWO_SIDED|95.0|-11.78|-1.91||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 2,CDAI|||-1.91|-11.78|0.007
72570590|NCT02504671|144670140|OTHER||Mean Difference (Net)|-7.92||||0.005|TWO_SIDED|95.0|-13.48|-2.37||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4,CDAI|||-2.37|-13.48|0.005
72570591|NCT02504671|144670140|OTHER||Mean Difference (Net)|-12.19|||<|0.001|TWO_SIDED|95.0|-17.74|-6.64||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4,CDAI|||-6.64|-17.74|<0.001
72570592|NCT02504671|144670140|OTHER||Mean Difference (Net)|-5.62||||0.059|TWO_SIDED|95.0|-11.45|0.21||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 6,CDAI|||0.21|-11.45|0.059
72570593|NCT02504671|144670140|OTHER||Mean Difference (Net)|-10.17|||<|0.001|TWO_SIDED|95.0|-15.97|-4.38||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 6,CDAI|||-4.38|-15.97|<0.001
72570594|NCT02504671|144670140|OTHER||Mean Difference (Net)|-10.37||||0.002|TWO_SIDED|95.0|-16.75|-4.0||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 8,CDAI|||-4.00|-16.75|0.002
72570595|NCT02504671|144670140|OTHER||Mean Difference (Net)|-13.79|||<|0.001|TWO_SIDED|95.0|-20.18|-7.41||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 8,CDAI|||-7.41|-20.18|<0.001
72570596|NCT02504671|144670140|OTHER||Mean Difference (Net)|-9.67||||0.01|TWO_SIDED|95.0|-17.03|-2.31||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12,CDAI|||-2.31|-17.03|0.010
72523180|NCT00565812|144576747|SUPERIORITY_OR_OTHER||LS mean difference|0.58|STANDARD_ERROR_OF_MEAN|1.39||0.676|TWO_SIDED|95.0|-2.14|3.3|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||3.30|-2.14|0.676
72570597|NCT02504671|144670140|OTHER||Mean Difference (Net)|-16.63|||<|0.001|TWO_SIDED|95.0|-23.97|-9.3||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12,CDAI|||-9.30|-23.97|<0.001
72570598|NCT02504671|144670140|OTHER||Mean Difference (Net)|-5.53||||0.165|TWO_SIDED|95.0|-13.37|2.3||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 16,CDAI|||2.30|-13.37|0.165
72523181|NCT00565812|144576747|SUPERIORITY_OR_OTHER||LS mean difference|-0.47|STANDARD_ERROR_OF_MEAN|1.38||0.732|TWO_SIDED|95.0|-3.18|2.23|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.23|-3.18|0.732
72523182|NCT00565812|144576748|SUPERIORITY_OR_OTHER||LS mean difference|0.13|STANDARD_ERROR_OF_MEAN|1.2||0.911|TWO_SIDED|95.0|-2.22|2.49|||Mixed Models Analysis|||Month 3; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.49|-2.22|0.911
72406340|NCT02942017|144321622|SUPERIORITY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.215||0.0683|TWO_SIDED|95.0|-0.82|0.03|||MMRM|||Depressed Mood, Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.03|-0.82|0.0683
72406341|NCT02942017|144321622|SUPERIORITY||LS Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.232||0.4458|TWO_SIDED|95.0|-0.64|0.28|||MMRM|||Depressed Mood, Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.28|-0.64|0.4458
72406342|NCT02942017|144321622|SUPERIORITY||LS Mean Difference|0.24|STANDARD_ERROR_OF_MEAN|0.228||0.2905|TWO_SIDED|95.0|-0.21|0.7|||MMRM|||Depressed Mood, Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.70|-0.21|0.2905
72523183|NCT00565812|144576748|SUPERIORITY_OR_OTHER||LS mean difference|-0.81|STANDARD_ERROR_OF_MEAN|1.2||0.5|TWO_SIDED|95.0|-3.16|1.54|||Mixed Models Analysis|||Month 3; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.54|-3.16|0.500
72523184|NCT00565812|144576748|SUPERIORITY_OR_OTHER||LS mean difference|0.67|STANDARD_ERROR_OF_MEAN|1.26||0.596|TWO_SIDED|95.0|-1.81|3.15|||Mixed Models Analysis|||Month 6; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||3.15|-1.81|0.596
72523185|NCT00565812|144576748|SUPERIORITY_OR_OTHER||LS mean difference|-0.03|STANDARD_ERROR_OF_MEAN|1.26||0.979|TWO_SIDED|95.0|-2.51|2.44|||Mixed Models Analysis|||Month 6; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.44|-2.51|0.979
72523186|NCT00565812|144576748|SUPERIORITY_OR_OTHER||LS mean difference|-0.59|STANDARD_ERROR_OF_MEAN|1.33||0.659|TWO_SIDED|95.0|-3.2|2.03|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.03|-3.20|0.659
72523187|NCT00565812|144576748|SUPERIORITY_OR_OTHER||LS mean difference|-0.3|STANDARD_ERROR_OF_MEAN|1.32||0.823|TWO_SIDED|95.0|-2.89|2.3|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.30|-2.89|0.823
72523188|NCT00565812|144576748|SUPERIORITY_OR_OTHER||LS mean difference|-1.24|STANDARD_ERROR_OF_MEAN|1.43||0.387|TWO_SIDED|95.0|-4.04|1.57|||Mixed Models Analysis|||Month 18; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.57|-4.04|0.387
72570599|NCT02504671|144670140|OTHER||Mean Difference (Net)|-8.85||||0.022|TWO_SIDED|95.0|-16.39|-1.32||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 16,CDAI|||-1.32|-16.39|0.022
72570600|NCT02504671|144670140|OTHER||Mean Difference (Net)|-6.55||||0.127|TWO_SIDED|95.0|-14.99|1.89||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 20,CDAI|||1.89|-14.99|0.127
72570601|NCT02504671|144670140|OTHER||Mean Difference (Net)|-8.67||||0.034|TWO_SIDED|95.0|-16.67|-0.67||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 20,CDAI|||-0.67|-16.67|0.034
72406343|NCT02942017|144321622|SUPERIORITY||LS Mean Difference|0.19|STANDARD_ERROR_OF_MEAN|0.182||0.3096|TWO_SIDED|95.0|-0.18|0.55|||MMRM|||Depressed Mood, Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.55|-0.18|0.3096
72406344|NCT02942017|144321622|SUPERIORITY||LS Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.165||0.1925|TWO_SIDED|95.0|-0.55|0.11|||MMRM|||Feeling of Guilt, Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.11|-0.55|0.1925
72570602|NCT02504671|144670140|OTHER||Mean Difference (Net)|-15.43||||0.004|TWO_SIDED|95.0|-25.78|-5.07||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24,CDAI|||-5.07|-25.78|0.004
72570603|NCT02504671|144670140|OTHER||Mean Difference (Net)|-19.88|||<|0.001|TWO_SIDED|95.0|-29.7|-10.06||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24,CDAI|||-10.06|-29.70|<0.001
72523189|NCT00565812|144576748|SUPERIORITY_OR_OTHER||LS mean difference|-0.48|STANDARD_ERROR_OF_MEAN|1.42||0.737|TWO_SIDED|95.0|-3.25|2.3|||Mixed Models Analysis|||Month 18; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.30|-3.25|0.737
72570604|NCT02504671|144670141|OTHER||Mean Difference (Net)|0.01||||0.938|TWO_SIDED|95.0|-0.14|0.16||MMRM analysis adjusted for HAQ-DI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 1, HAQ-DI|||0.16|-0.14|0.938
72570605|NCT02504671|144670141|OTHER||Mean Difference (Net)|0.0||||0.981|TWO_SIDED|95.0|-0.15|0.15||MMRM analysis adjusted for HAQ-DI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 1, HAQ-DI|||0.15|-0.15|0.981
72570606|NCT02504671|144670141|OTHER||Mean Difference (Net)|-0.01||||0.857|TWO_SIDED|95.0|-0.16|0.14||MMRM analysis adjusted for HAQ-DI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 1, HAQ-DI|||0.14|-0.16|0.857
72570607|NCT02504671|144670141|OTHER||Mean Difference (Net)|0.05||||0.592|TWO_SIDED|95.0|-0.13|0.22||MMRM analysis adjusted for HAQ-DI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 2, HAQ-DI|||0.22|-0.13|0.592
72570608|NCT02504671|144670141|OTHER||Mean Difference (Net)|0.01||||0.917|TWO_SIDED|95.0|-0.16|0.18||MMRM analysis adjusted for HAQ-DI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 2, HAQ-DI|||0.18|-0.16|0.917
72570609|NCT02504671|144670141|OTHER||Mean Difference (Net)|-0.05||||0.545|TWO_SIDED|95.0|-0.23|0.12||MMRM analysis adjusted for HAQ-DI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 2, HAQ-DI|||0.12|-0.23|0.545
72570610|NCT02504671|144670141|OTHER||Mean Difference (Net)|0.04||||0.707|TWO_SIDED|95.0|-0.16|0.24||MMRM analysis adjusted for HAQ-DI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, HAQ-DI|||0.24|-0.16|0.707
72570611|NCT02504671|144670141|OTHER||Mean Difference (Net)|0.05||||0.603|TWO_SIDED|95.0|-0.15|0.26||MMRM analysis adjusted for HAQ-DI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, HAQ-DI|||0.26|-0.15|0.603
72523190|NCT00565812|144576748|SUPERIORITY_OR_OTHER||LS mean difference|1.12|STANDARD_ERROR_OF_MEAN|1.45||0.443|TWO_SIDED|95.0|-1.73|3.97|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||3.97|-1.73|0.443
72570612|NCT02504671|144670141|OTHER||Mean Difference (Net)|-0.07||||0.473|TWO_SIDED|95.0|-0.27|0.13||MMRM analysis adjusted for HAQ-DI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, HAQ-DI|||0.13|-0.27|0.473
72570613|NCT02504671|144670141|OTHER||Mean Difference (Net)|0.0||||0.987|TWO_SIDED|95.0|-0.21|0.22||MMRM analysis adjusted for HAQ-DI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 6, HAQ-DI|||0.22|-0.21|0.987
72570614|NCT02504671|144670141|OTHER||Mean Difference (Net)|-0.04||||0.713|TWO_SIDED|95.0|-0.25|0.17||MMRM analysis adjusted for HAQ-DI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 6, HAQ-DI|||0.17|-0.25|0.713
72570615|NCT02504671|144670141|OTHER||Mean Difference (Net)|-0.1||||0.357|TWO_SIDED|95.0|-0.31|0.11||MMRM analysis adjusted for HAQ-DI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 6, HAQ-DI|||0.11|-0.31|0.357
72570616|NCT02504671|144670141|OTHER||Mean Difference (Final Values)|0.04||||0.748|TWO_SIDED|95.0|-0.19|0.26||MMRM analysis adjusted for HAQ-DI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 8, HAQ-DI|||0.26|-0.19|0.748
72570617|NCT02504671|144670141|OTHER||Mean Difference (Net)|-0.11||||0.327|TWO_SIDED|95.0|-0.34|0.11||MMRM analysis adjusted for HAQ-DI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 8, HAQ-DI|||0.11|-0.34|0.327
72570618|NCT02504671|144670141|OTHER||Mean Difference (Net)|-0.1||||0.395|TWO_SIDED|95.0|-0.32|0.13||MMRM analysis adjusted for HAQ-DI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 8, HAQ-DI|||0.13|-0.32|0.395
72570619|NCT02504671|144670141|OTHER||Mean Difference (Net)|-0.05||||0.71|TWO_SIDED|95.0|-0.3|0.21||MMRM analysis adjusted for HAQ-DI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, HAQ-DI|||0.21|-0.30|0.710
72570620|NCT02504671|144670141|OTHER||Mean Difference (Net)|-0.04||||0.74|TWO_SIDED|95.0|-0.3|0.21||MMRM analysis adjusted for HAQ-DI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, HAQ-DI|||0.21|-0.30|0.740
72570621|NCT02504671|144670141|OTHER||Mean Difference (Net)|-0.11||||0.398|TWO_SIDED|95.0|-0.36|0.14||MMRM analysis adjusted for HAQ-DI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, HAQ-DI|||0.14|-0.36|0.398
72570622|NCT02504671|144670141|OTHER||Mean Difference (Net)|0.16||||0.364|TWO_SIDED|95.0|-0.19|0.52||MMRM analysis adjusted for HAQ-DI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 16, HAQ-DI|||0.52|-0.19|0.364
72570623|NCT02504671|144670141|OTHER||Mean Difference (Net)|0.12||||0.503|TWO_SIDED|95.0|-0.23|0.46||MMRM analysis adjusted for HAQ-DI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 16, HAQ-DI|||0.46|-0.23|0.503
72570624|NCT02504671|144670141|OTHER||Mean Difference (Net)|-0.08||||0.647|TWO_SIDED|95.0|-0.42|0.26||MMRM analysis adjusted for HAQ-DI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 16, HAQ-DI|||0.26|-0.42|0.647
72570625|NCT02504671|144670141|OTHER||Mean Difference (Net)|-0.02||||0.91|TWO_SIDED|95.0|-0.37|0.33||MMRM analysis adjusted for HAQ-DI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 20, HAQ-DI|||0.33|-0.37|0.910
72523191|NCT00565812|144576748|SUPERIORITY_OR_OTHER||LS mean difference|-0.79|STANDARD_ERROR_OF_MEAN|1.44||0.585|TWO_SIDED|95.0|-3.62|2.04|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.04|-3.62|0.585
72523192|NCT00565812|144576749|SUPERIORITY_OR_OTHER||LS mean difference|0.58|STANDARD_ERROR_OF_MEAN|1.16||0.613|TWO_SIDED|95.0|-1.68|2.85|||Mixed Models Analysis|||Month 3; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.85|-1.68|0.613
72523193|NCT00565812|144576749|SUPERIORITY_OR_OTHER||LS mean difference|-0.49|STANDARD_ERROR_OF_MEAN|1.16||0.67|TWO_SIDED|95.0|-2.76|1.78|||Mixed Models Analysis|||Month 3; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.78|-2.76|0.670
72523194|NCT00565812|144576749|SUPERIORITY_OR_OTHER||LS mean difference|-1.33|STANDARD_ERROR_OF_MEAN|1.27||0.296|TWO_SIDED|95.0|-3.82|1.16|||Mixed Models Analysis|||Month 6; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.16|-3.82|0.296
72523195|NCT00565812|144576749|SUPERIORITY_OR_OTHER||LS mean difference|-0.66|STANDARD_ERROR_OF_MEAN|1.27||0.604|TWO_SIDED|95.0|-3.15|1.83|||Mixed Models Analysis|||Month 6; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.83|-3.15|0.604
72523196|NCT00565812|144576749|SUPERIORITY_OR_OTHER||LS mean difference|-1.86|STANDARD_ERROR_OF_MEAN|1.33||0.163|TWO_SIDED|95.0|-4.46|0.75|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.75|-4.46|0.163
72523197|NCT00565812|144576749|SUPERIORITY_OR_OTHER||LS mean difference|-0.1|STANDARD_ERROR_OF_MEAN|1.32||0.939|TWO_SIDED|95.0|-2.69|2.48|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.48|-2.69|0.939
72406345|NCT02942017|144321622|SUPERIORITY||LS Mean Difference|-0.44|STANDARD_ERROR_OF_MEAN|0.168||0.0101|TWO_SIDED|95.0|-0.77|-0.11|||MMRM|||Feeling of Guilt, Hour 4:MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.11|-0.77|0.0101
72523198|NCT00565812|144576749|SUPERIORITY_OR_OTHER||LS mean difference|-1.74|STANDARD_ERROR_OF_MEAN|1.46||0.233|TWO_SIDED|95.0|-4.61|1.12|||Mixed Models Analysis|||Month 18; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.12|-4.61|0.233
72523199|NCT00565812|144576749|SUPERIORITY_OR_OTHER||LS mean difference|0.52|STANDARD_ERROR_OF_MEAN|1.45||0.72|TWO_SIDED|95.0|-2.32|3.36|||Mixed Models Analysis|||Month 18; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||3.36|-2.32|0.720
72523200|NCT00565812|144576749|SUPERIORITY_OR_OTHER||LS mean difference|0.01|STANDARD_ERROR_OF_MEAN|1.45||0.993|TWO_SIDED|95.0|-2.82|2.85|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.85|-2.82|0.993
72570626|NCT02504671|144670141|OTHER||Mean Difference (Net)|-0.08||||0.66|TWO_SIDED|95.0|-0.42|0.26||MMRM analysis adjusted for HAQ-DI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 20, HAQ-DI|||0.26|-0.42|0.660
72570627|NCT02504671|144670141|OTHER||Mean Difference (Net)|-0.16||||0.34|TWO_SIDED|95.0|-0.5|0.17||MMRM analysis adjusted for HAQ-DI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 20, HAQ-DI|||0.17|-0.50|0.340
72570628|NCT02504671|144670141|OTHER||Mean Difference (Net)|0.02||||0.902|TWO_SIDED|95.0|-0.34|0.39||MMRM analysis adjusted for HAQ-DI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, HAQ-DI|||0.39|-0.34|0.902
72570629|NCT02504671|144670141|OTHER||Mean Difference (Net)|-0.07||||0.687|TWO_SIDED|95.0|-0.42|0.28||MMRM analysis adjusted for HAQ-DI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, HAQ-DI|||0.28|-0.42|0.687
72570630|NCT02504671|144670141|OTHER||Mean Difference (Net)|-0.09||||0.599|TWO_SIDED|95.0|-0.44|0.25||MMRM analysis adjusted for HAQ-DI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, HAQ-DI|||0.25|-0.44|0.599
72570631|NCT02504671|144670141|OTHER||Mean Difference (Net)|-0.04||||0.588|TWO_SIDED|95.0|-0.19|0.11||MMRM analysis adjusted for HAQ-DI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 1, HAQ-DI|||0.11|-0.19|0.588
72406346|NCT02942017|144321622|SUPERIORITY||LS Mean Difference|-0.23|STANDARD_ERROR_OF_MEAN|0.163||0.1546|TWO_SIDED|95.0|-0.56|0.09|||MMRM|||Feeling of Guilt, Hour 8:MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.09|-0.56|0.1546
72406347|NCT02942017|144321622|SUPERIORITY||LS Mean Difference|-0.29|STANDARD_ERROR_OF_MEAN|0.168||0.0901|TWO_SIDED|95.0|-0.62|0.05|||MMRM|||Feeling of Guilt, Hour 12:MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.05|-0.62|0.0901
72406348|NCT02942017|144321622|SUPERIORITY||LS Mean Difference|-0.29|STANDARD_ERROR_OF_MEAN|0.162||0.0717|TWO_SIDED|95.0|-0.62|0.03|||MMRM|||Feeling of Guilt, Hour 24:MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.03|-0.62|0.0717
72523201|NCT00565812|144576749|SUPERIORITY_OR_OTHER||LS mean difference|-0.38|STANDARD_ERROR_OF_MEAN|1.44||0.794|TWO_SIDED|95.0|-3.19|2.44|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.44|-3.19|0.794
72523202|NCT00565812|144576750|SUPERIORITY_OR_OTHER||LS mean difference|0.97|STANDARD_ERROR_OF_MEAN|0.53||0.069|TWO_SIDED|95.0|-0.07|2.02|||Mixed Models Analysis|||Month 3; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.02|-0.07|0.069
72523203|NCT00565812|144576750|SUPERIORITY_OR_OTHER||LS mean difference|0.52|STANDARD_ERROR_OF_MEAN|0.54||0.335|TWO_SIDED|95.0|-0.53|1.57|||Mixed Models Analysis|||Month 3; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.57|-0.53|0.335
72523204|NCT00565812|144576750|SUPERIORITY_OR_OTHER||LS mean difference|0.89|STANDARD_ERROR_OF_MEAN|0.62||0.153|TWO_SIDED|95.0|-0.33|2.11|||Mixed Models Analysis|||Month 6; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.11|-0.33|0.153
72523205|NCT00565812|144576750|SUPERIORITY_OR_OTHER||LS mean difference|0.26|STANDARD_ERROR_OF_MEAN|0.62||0.672|TWO_SIDED|95.0|-0.95|1.47|||Mixed Models Analysis|||Month 6; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.47|-0.95|0.672
72523206|NCT00565812|144576750|SUPERIORITY_OR_OTHER||LS mean difference|0.19|STANDARD_ERROR_OF_MEAN|0.63||0.765|TWO_SIDED|95.0|-1.05|1.43|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.43|-1.05|0.765
72523207|NCT00565812|144576750|SUPERIORITY_OR_OTHER||LS mean difference|0.26|STANDARD_ERROR_OF_MEAN|0.62||0.675|TWO_SIDED|95.0|-0.96|1.49|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.49|-0.96|0.675
72523208|NCT00565812|144576750|SUPERIORITY_OR_OTHER||LS mean difference|0.42|STANDARD_ERROR_OF_MEAN|0.72||0.56|TWO_SIDED|95.0|-1.0|1.84|||Mixed Models Analysis|||Month 18; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.84|-1.00|0.560
72570632|NCT02504671|144670141|OTHER||Mean Difference (Net)|-0.09||||0.259|TWO_SIDED|95.0|-0.23|0.06||MMRM analysis adjusted for HAQ-DI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 1, HAQ-DI|||0.06|-0.23|0.259
72570633|NCT02504671|144670141|OTHER||Mean Difference (Net)|-0.08||||0.358|TWO_SIDED|95.0|-0.26|0.09||MMRM analysis adjusted for HAQ-DI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 2, HAQ-DI|||0.09|-0.26|0.358
72570634|NCT02504671|144670141|OTHER||Mean Difference (Net)|-0.09||||0.325|TWO_SIDED|95.0|-0.26|0.09||MMRM analysis adjusted for HAQ-DI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 2, HAQ-DI|||0.09|-0.26|0.325
72570635|NCT02504671|144670141|OTHER||Mean Difference (Net)|-0.07||||0.473|TWO_SIDED|95.0|-0.28|0.13||MMRM analysis adjusted for HAQ-DI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, HAQ-DI|||0.13|-0.28|0.473
72570636|NCT02504671|144670141|OTHER||Mean Difference (Net)|-0.18||||0.085|TWO_SIDED|95.0|-0.38|0.02||MMRM analysis adjusted for HAQ-DI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, HAQ-DI|||0.02|-0.38|0.085
72570637|NCT02504671|144670141|OTHER||Mean Difference (Net)|0.01||||0.897|TWO_SIDED|95.0|-0.2|0.23||MMRM analysis adjusted for HAQ-DI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 6, HAQ-DI|||0.23|-0.20|0.897
72406349|NCT02942017|144321622|SUPERIORITY||LS Mean Difference|-0.34|STANDARD_ERROR_OF_MEAN|0.169||0.0468|TWO_SIDED|95.0|-0.68|0.0|||MMRM|||Feeling of Guilt, Hour 36:MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.00|-0.68|0.0468
72523209|NCT00565812|144576750|SUPERIORITY_OR_OTHER||LS mean difference|0.56|STANDARD_ERROR_OF_MEAN|0.72||0.433|TWO_SIDED|95.0|-0.84|1.97|||Mixed Models Analysis|||Month 18; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.97|-0.84|0.433
72570638|NCT02504671|144670141|OTHER||Mean Difference (Net)|-0.2||||0.065|TWO_SIDED|95.0|-0.42|0.01||MMRM analysis adjusted for HAQ-DI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 6, HAQ-DI|||0.01|-0.42|0.065
72570639|NCT02504671|144670141|OTHER||Mean Difference (Net)|-0.14||||0.238|TWO_SIDED|95.0|-0.36|0.09||MMRM analysis adjusted for HAQ-DI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 8, HAQ-DI|||0.09|-0.36|0.238
72570640|NCT02504671|144670141|OTHER||Mean Difference (Net)|-0.21||||0.071|TWO_SIDED|95.0|-0.44|0.02||MMRM analysis adjusted for HAQ-DI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 8, HAQ-DI|||0.02|-0.44|0.071
72570641|NCT02504671|144670141|OTHER||Mean Difference (Net)|-0.12||||0.34|TWO_SIDED|95.0|-0.38|0.13||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, HAQ-DI|||0.13|-0.38|0.340
72570642|NCT02504671|144670141|OTHER||Mean Difference (Net)|-0.24||||0.059|TWO_SIDED|95.0|-0.49|0.01||MMRM analysis adjusted for HAQ-DI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, HAQ-DI|||0.01|-0.49|0.059
72570643|NCT02504671|144670141|OTHER||Mean Difference (Net)|0.09||||0.607|TWO_SIDED|95.0|-0.26|0.44||MMRM analysis adjusted for HAQ-DI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 16, HAQ-DI|||0.44|-0.26|0.607
72570644|NCT02504671|144670141|OTHER||Mean Difference (Net)|-0.01||||0.959|TWO_SIDED|95.0|-0.34|0.32||MMRM analysis adjusted for HAQ-DI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 16, HAQ-DI|||0.32|-0.34|0.959
72570645|NCT02504671|144670141|OTHER||Mean Difference (Net)|-0.15||||0.401|TWO_SIDED|95.0|-0.49|0.2||MMRM analysis adjusted for HAQ-DI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 20, HAQ-DI|||0.20|-0.49|0.401
72570646|NCT02504671|144670141|OTHER||Mean Difference (Net)|-0.21||||0.207|TWO_SIDED|95.0|-0.54|0.12||MMRM analysis adjusted for HAQ-DI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 20, HAQ-DI|||0.12|-0.54|0.207
72523210|NCT00565812|144576750|SUPERIORITY_OR_OTHER||LS mean difference|0.73|STANDARD_ERROR_OF_MEAN|0.73||0.318|TWO_SIDED|95.0|-0.7|2.16|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.16|-0.70|0.318
72523211|NCT00565812|144576750|SUPERIORITY_OR_OTHER||LS mean difference|0.75|STANDARD_ERROR_OF_MEAN|0.73||0.303|TWO_SIDED|95.0|-0.68|2.18|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.18|-0.68|0.303
72523212|NCT00565812|144576751|SUPERIORITY_OR_OTHER||LS mean difference|1.67|STANDARD_ERROR_OF_MEAN|0.81||0.039|TWO_SIDED|95.0|0.08|3.26|||Mixed Models Analysis|||Month 3; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLGU\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||3.26|0.08|0.039
72523213|NCT00565812|144576751|SUPERIORITY_OR_OTHER||LS mean difference|0.7|STANDARD_ERROR_OF_MEAN|0.82||0.395|TWO_SIDED|95.0|-0.91|2.3|||Mixed Models Analysis|||Month 3; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.30|-0.91|0.395
72523214|NCT00565812|144576751|SUPERIORITY_OR_OTHER||LS mean difference|1.36|STANDARD_ERROR_OF_MEAN|0.96||0.16|TWO_SIDED|95.0|-0.54|3.25|||Mixed Models Analysis|||Month 6; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||3.25|-0.54|0.160
72570647|NCT02504671|144670141|OTHER||Mean Difference (Net)|-0.08||||0.637|TWO_SIDED|95.0|-0.44|0.27||MMRM analysis adjusted for HAQ-DI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, HAQ-DI|||0.27|-0.44|0.637
72570648|NCT02504671|144670141|OTHER||Mean Difference (Final Values)|-0.2||||0.251|TWO_SIDED|95.0|-0.53|0.14||MMRM analysis adjusted for HAQ-DI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, HAQ-DI|||0.14|-0.53|0.251
72570649|NCT02504671|144670142|OTHER||Mean Difference (Net)|-2.45||||0.511|TWO_SIDED|95.0|-9.81|4.9||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 1, Pain score|||4.90|-9.81|0.511
72523215|NCT00565812|144576751|SUPERIORITY_OR_OTHER||LS mean difference|0.46|STANDARD_ERROR_OF_MEAN|0.97||0.638|TWO_SIDED|95.0|-1.44|2.35|||Mixed Models Analysis|||Month 6; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.35|-1.44|0.638
72523216|NCT00565812|144576751|SUPERIORITY_OR_OTHER||LS mean difference|0.61|STANDARD_ERROR_OF_MEAN|0.98||0.537|TWO_SIDED|95.0|-1.32|2.54|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.54|-1.32|0.537
72523217|NCT00565812|144576751|SUPERIORITY_OR_OTHER||LS mean difference|0.01|STANDARD_ERROR_OF_MEAN|0.98||0.988|TWO_SIDED|95.0|-1.9|1.93|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*(visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.93|-1.90|0.988
72523218|NCT00565812|144576751|SUPERIORITY_OR_OTHER||LS mean difference|0.05|STANDARD_ERROR_OF_MEAN|1.11||0.962|TWO_SIDED|95.0|-2.12|2.22|||Mixed Models Analysis|||Month 18; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.22|-2.12|0.962
72523219|NCT00565812|144576751|SUPERIORITY_OR_OTHER||LS mean difference|0.2|STANDARD_ERROR_OF_MEAN|1.11||0.856|TWO_SIDED|95.0|-1.97|2.37|||Mixed Models Analysis|||Month 18; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.37|-1.97|0.856
72523220|NCT00565812|144576751|SUPERIORITY_OR_OTHER||LS mean difference|1.36|STANDARD_ERROR_OF_MEAN|1.15||0.237|TWO_SIDED|95.0|-0.9|3.63|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||3.63|-0.90|0.237
72523221|NCT00565812|144576751|SUPERIORITY_OR_OTHER||LS mean difference|0.82|STANDARD_ERROR_OF_MEAN|1.15||0.475|TWO_SIDED|95.0|-1.44|3.09|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||3.09|-1.44|0.475
72523222|NCT00565812|144576752|SUPERIORITY_OR_OTHER||LS mean difference|0.04|STANDARD_ERROR_OF_MEAN|0.57||0.938|TWO_SIDED|95.0|-1.07|1.16|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.16|-1.07|0.938
72523223|NCT00565812|144576752|SUPERIORITY_OR_OTHER||LS mean difference|0.07|STANDARD_ERROR_OF_MEAN|0.56||0.906|TWO_SIDED|95.0|-1.04|1.17|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.17|-1.04|0.906
72523224|NCT00565812|144576752|SUPERIORITY_OR_OTHER||LS mean difference|-0.23|STANDARD_ERROR_OF_MEAN|0.65||0.726|TWO_SIDED|95.0|-1.5|1.04|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.04|-1.50|0.726
72523225|NCT00565812|144576752|SUPERIORITY_OR_OTHER||LS mean difference|-0.26|STANDARD_ERROR_OF_MEAN|0.64||0.681|TWO_SIDED|95.0|-1.52|1.0|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.00|-1.52|0.681
72523226|NCT00565812|144576753|SUPERIORITY_OR_OTHER||LS mean difference|0.07|STANDARD_ERROR_OF_MEAN|0.58||0.9|TWO_SIDED|95.0|-1.07|1.21|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.21|-1.07|0.900
72570650|NCT02504671|144670142|OTHER||Mean Difference (Net)|-2.76||||0.461|TWO_SIDED|95.0|-10.13|4.6||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 1, Pain score|||4.60|-10.13|0.461
72570651|NCT02504671|144670142|OTHER||Mean Difference (Net)|-7.71||||0.039|TWO_SIDED|95.0|-15.03|-0.39||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 1, Pain score|||-0.39|-15.03|0.039
72570652|NCT02504671|144670142|OTHER||Mean Difference (Net)|-2.92||||0.469|TWO_SIDED|95.0|-10.86|5.01||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 2, Pain score|||5.01|-10.86|0.469
72406350|NCT02942017|144321622|SUPERIORITY||LS Mean Difference|-0.21|STANDARD_ERROR_OF_MEAN|0.173||0.2222|TWO_SIDED|95.0|-0.56|0.13|||MMRM|||Feeling of Guilt, Hour 48:MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.13|-0.56|0.2222
72406351|NCT02942017|144321622|SUPERIORITY||LS Mean Difference|-0.29|STANDARD_ERROR_OF_MEAN|0.156||0.0682|TWO_SIDED|95.0|-0.6|0.02|||MMRM|||Feeling of Guilt, Hour 60:MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.02|-0.60|0.0682
72523227|NCT00565812|144576753|SUPERIORITY_OR_OTHER||LS mean difference|0.36|STANDARD_ERROR_OF_MEAN|0.58||0.528|TWO_SIDED|95.0|-0.77|1.5|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.50|-0.77|0.528
72523228|NCT00565812|144576753|SUPERIORITY_OR_OTHER||LS mean difference|-0.29|STANDARD_ERROR_OF_MEAN|0.62||0.647|TWO_SIDED|95.0|-1.51|0.94|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.94|-1.51|0.647
72523229|NCT00565812|144576753|SUPERIORITY_OR_OTHER||LS mean difference|-0.12|STANDARD_ERROR_OF_MEAN|0.62||0.841|TWO_SIDED|95.0|-1.34|1.09|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.09|-1.34|0.841
72523230|NCT00565812|144576754|SUPERIORITY_OR_OTHER||LS mean difference|0.32|STANDARD_ERROR_OF_MEAN|0.59||0.587|TWO_SIDED|95.0|-0.84|1.48|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.48|-0.84|0.587
72523231|NCT00565812|144576754|SUPERIORITY_OR_OTHER||LS mean difference|0.24|STANDARD_ERROR_OF_MEAN|0.58||0.687|TWO_SIDED|95.0|-0.91|1.38|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.38|-0.91|0.687
72523232|NCT00565812|144576754|SUPERIORITY_OR_OTHER||LS mean difference|-0.27|STANDARD_ERROR_OF_MEAN|0.65||0.677|TWO_SIDED|95.0|-1.56|1.01|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.01|-1.56|0.677
72523233|NCT00565812|144576754|SUPERIORITY_OR_OTHER||LS mean difference|0.47|STANDARD_ERROR_OF_MEAN|0.65||0.469|TWO_SIDED|95.0|-0.8|1.74|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.74|-0.80|0.469
72570653|NCT02504671|144670142|OTHER||Mean Difference (Net)|-5.99||||0.133|TWO_SIDED|95.0|-13.82|1.85||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 2, Pain score|||1.85|-13.82|0.133
72523234|NCT00565812|144576755|SUPERIORITY_OR_OTHER||LS mean difference|0.23|STANDARD_ERROR_OF_MEAN|0.48||0.632|TWO_SIDED|95.0|-0.71|1.17|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.17|-0.71|0.632
72523235|NCT00565812|144576755|SUPERIORITY_OR_OTHER||LS mean difference|0.49|STANDARD_ERROR_OF_MEAN|0.48||0.308|TWO_SIDED|95.0|-0.45|1.42|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.42|-0.45|0.308
72523236|NCT00565812|144576755|SUPERIORITY_OR_OTHER||LS mean difference|-0.27|STANDARD_ERROR_OF_MEAN|0.54||0.615|TWO_SIDED|95.0|-1.33|0.79|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.79|-1.33|0.615
72570654|NCT02504671|144670142|OTHER||Mean Difference (Net)|-7.58||||0.057|TWO_SIDED|95.0|-15.4|0.23||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 2, Pain score|||0.23|-15.40|0.057
72570655|NCT02504671|144670142|OTHER||Mean Difference (Net)|-3.03||||0.49|TWO_SIDED|95.0|-11.67|5.61||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, Pain score|||5.61|-11.67|0.490
72570656|NCT02504671|144670142|OTHER||Mean Difference (Net)|-9.38||||0.031|TWO_SIDED|95.0|-17.91|-0.86||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, Pain score|||-0.86|-17.91|0.031
72406352|NCT02942017|144321622|SUPERIORITY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.16||0.0147|TWO_SIDED|95.0|-0.72|-0.08|||MMRM|||Feeling of Guilt, Hour 72:MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.08|-0.72|0.0147
72406353|NCT02942017|144321622|SUPERIORITY||LS Mean Difference|-0.32|STANDARD_ERROR_OF_MEAN|0.182||0.0837|TWO_SIDED|95.0|-0.68|0.04|||MMRM|||Feeling of Guilt, Day 7:MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.04|-0.68|0.0837
72523237|NCT00565812|144576755|SUPERIORITY_OR_OTHER||LS mean difference|-0.43|STANDARD_ERROR_OF_MEAN|0.53||0.425|TWO_SIDED|95.0|-1.48|0.62|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.62|-1.48|0.425
72523238|NCT00565812|144576756|SUPERIORITY_OR_OTHER||LS mean difference|0.67|STANDARD_ERROR_OF_MEAN|0.54||0.214|TWO_SIDED|95.0|-0.39|1.72|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.72|-0.39|0.214
72523239|NCT00565812|144576756|SUPERIORITY_OR_OTHER||LS mean difference|-0.01|STANDARD_ERROR_OF_MEAN|0.53||0.98|TWO_SIDED|95.0|-1.06|1.03|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.03|-1.06|0.980
72523240|NCT00565812|144576756|SUPERIORITY_OR_OTHER||LS mean difference|0.33|STANDARD_ERROR_OF_MEAN|0.59||0.575|TWO_SIDED|95.0|-0.83|1.49|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.49|-0.83|0.575
72523241|NCT00565812|144576756|SUPERIORITY_OR_OTHER||LS mean difference|-0.01|STANDARD_ERROR_OF_MEAN|0.59||0.986|TWO_SIDED|95.0|-1.16|1.14|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.14|-1.16|0.986
72570657|NCT02504671|144670142|OTHER||Mean Difference (Net)|-12.21||||0.005|TWO_SIDED|95.0|-20.67|-3.74||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, Pain score|||-3.74|-20.67|0.005
72570658|NCT02504671|144670142|OTHER||Mean Difference (Net)|-4.49||||0.345|TWO_SIDED|95.0|-13.83|4.85||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 6, Pain score|||4.85|-13.83|0.345
72523242|NCT00565812|144576757|SUPERIORITY_OR_OTHER||LS mean difference|1.33|STANDARD_ERROR_OF_MEAN|0.61||0.03|TWO_SIDED|95.0|0.13|2.52|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.52|0.13|0.030
72523243|NCT00565812|144576757|SUPERIORITY_OR_OTHER||LS mean difference|0.43|STANDARD_ERROR_OF_MEAN|0.6||0.48|TWO_SIDED|95.0|-0.76|1.61|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.61|-0.76|0.480
72523244|NCT00565812|144576757|SUPERIORITY_OR_OTHER||LS mean difference|1.01|STANDARD_ERROR_OF_MEAN|0.67||0.132|TWO_SIDED|95.0|-0.3|2.32|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.32|-0.30|0.132
72523245|NCT00565812|144576757|SUPERIORITY_OR_OTHER||LS mean difference|1.04|STANDARD_ERROR_OF_MEAN|0.66||0.117|TWO_SIDED|95.0|-0.26|2.34|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.34|-0.26|0.117
72523246|NCT00565812|144576758|SUPERIORITY_OR_OTHER||LS mean difference|1.06|STANDARD_ERROR_OF_MEAN|0.71||0.133|TWO_SIDED|95.0|-0.32|2.44|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.44|-0.32|0.133
72570659|NCT02504671|144670142|OTHER||Mean Difference (Net)|-8.02||||0.09|TWO_SIDED|95.0|-17.3|1.26||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 6, Pain score|||1.26|-17.30|0.090
72570660|NCT02504671|144670142|OTHER||Mean Difference (Net)|-8.36||||0.074|TWO_SIDED|95.0|-17.55|0.83||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 6, Pain score|||0.83|-17.55|0.074
72523247|NCT00565812|144576758|SUPERIORITY_OR_OTHER||LS mean difference|0.44|STANDARD_ERROR_OF_MEAN|0.7||0.524|TWO_SIDED|95.0|-0.93|1.82|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.82|-0.93|0.524
72523248|NCT00565812|144576758|SUPERIORITY_OR_OTHER||LS mean difference|0.26|STANDARD_ERROR_OF_MEAN|0.78||0.743|TWO_SIDED|95.0|-1.27|1.78|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.78|-1.27|0.743
72523249|NCT00565812|144576758|SUPERIORITY_OR_OTHER||LS mean difference|0.78|STANDARD_ERROR_OF_MEAN|0.77||0.31|TWO_SIDED|95.0|-0.73|2.3|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.30|-0.73|0.310
72523250|NCT00565812|144576759|SUPERIORITY_OR_OTHER||LS mean difference|1.17|STANDARD_ERROR_OF_MEAN|0.62||0.058|TWO_SIDED|95.0|-0.04|2.38|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.38|-0.04|0.058
72523251|NCT00565812|144576759|SUPERIORITY_OR_OTHER||LS mean difference|0.76|STANDARD_ERROR_OF_MEAN|0.61||0.213|TWO_SIDED|95.0|-0.44|1.96|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.96|-0.44|0.213
72523252|NCT00565812|144576759|SUPERIORITY_OR_OTHER||LS mean difference|0.98|STANDARD_ERROR_OF_MEAN|0.67||0.143|TWO_SIDED|95.0|-0.33|2.3|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.30|-0.33|0.143
72570661|NCT02504671|144670142|OTHER||Mean Difference (Net)|-5.61||||0.268|TWO_SIDED|95.0|-15.57|4.34||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 8, Pain score|||4.34|-15.57|0.268
72406354|NCT02942017|144321622|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.179||0.5828|TWO_SIDED|95.0|-0.46|0.26|||MMRM|||Feeling of Guilt, Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.26|-0.46|0.5828
72523253|NCT00565812|144576759|SUPERIORITY_OR_OTHER||LS mean difference|0.5|STANDARD_ERROR_OF_MEAN|0.67||0.45|TWO_SIDED|95.0|-0.8|1.81|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.81|-0.80|0.450
72523254|NCT00565812|144576760|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.51||0.701|TWO_SIDED|95.0|-1.19|0.8|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.80|-1.19|0.701
72523255|NCT00565812|144576760|SUPERIORITY_OR_OTHER||LS Mean Difference|0.15|STANDARD_ERROR_OF_MEAN|0.5||0.764|TWO_SIDED|95.0|-0.84|1.14|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.14|-0.84|0.764
72523256|NCT00565812|144576760|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.68|STANDARD_ERROR_OF_MEAN|0.57||0.228|TWO_SIDED|95.0|-1.8|0.43|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.43|-1.80|0.228
72523257|NCT00565812|144576760|SUPERIORITY_OR_OTHER||LS mean difference|-0.37|STANDARD_ERROR_OF_MEAN|0.56||0.514|TWO_SIDED|95.0|-1.47|0.74|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit,a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.74|-1.47|0.514
72570662|NCT02504671|144670142|OTHER||Mean Difference (Net)|-14.57||||0.004|TWO_SIDED|95.0|-24.43|-4.7||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 8, Pain score|||-4.70|-24.43|0.004
72406355|NCT02942017|144321622|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.168||0.5674|TWO_SIDED|95.0|-0.43|0.24|||MMRM|||Feeling of Guilt, Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.24|-0.43|0.5674
72406356|NCT02942017|144321622|SUPERIORITY||LS Mean Difference|0.11|STANDARD_ERROR_OF_MEAN|0.145||0.4613|TWO_SIDED|95.0|-0.18|0.4|||MMRM|||Feeling of Guilt, Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.40|-0.18|0.4613
72406357|NCT02942017|144321622|SUPERIORITY||LS Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.082||0.324|TWO_SIDED|95.0|-0.24|0.08|||MMRM|||Suicide, Hour 2:MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.08|-0.24|0.3240
72523258|NCT00565812|144576761|SUPERIORITY_OR_OTHER||LS mean difference|1.42|STANDARD_ERROR_OF_MEAN|0.62||0.023|TWO_SIDED|95.0|0.19|2.65|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.65|0.19|0.023
72523259|NCT00565812|144576761|SUPERIORITY_OR_OTHER||LS mean difference|0.53|STANDARD_ERROR_OF_MEAN|0.62||0.391|TWO_SIDED|95.0|-0.68|1.75|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.75|-0.68|0.391
72523260|NCT00565812|144576761|SUPERIORITY_OR_OTHER||LS mean difference|1.02|STANDARD_ERROR_OF_MEAN|0.69||0.142|TWO_SIDED|95.0|-0.34|2.37|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.37|-0.34|0.142
72523261|NCT00565812|144576761|SUPERIORITY_OR_OTHER||LS mean difference|0.87|STANDARD_ERROR_OF_MEAN|0.68||0.204|TWO_SIDED|95.0|-0.47|2.21|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.21|-0.47|0.204
72523262|NCT00565812|144576768|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.952||||0.875|TWO_SIDED|95.0|0.516|1.756|||Regression, Logistic|||Month 12; Odds ratio (OR), 95 percent CI and P-values were obtained from a logistic regression model, with treatment group, (collapsed) KLG, geographic region, and gender as factors, age and body mass index as covariates.||1.756|0.516|0.875
72523263|NCT00565812|144576768|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.273||||0.406|TWO_SIDED|95.0|0.721|2.247|||Regression, Logistic|||Month 12; Odds ratio, 95 percent CI and P-values were obtained from a logistic regression model, with treatment group, (collapsed) KLG, geographic region, and gender as factors, age and body mass index as covariates.||2.247|0.721|0.406
72523264|NCT00565812|144576768|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.787||||0.406|TWO_SIDED|95.0|0.448|1.384|||Regression, Logistic|||Month 24; Odds ratio, 95 percent CI and P-values were obtained from a logistic regression model, with treatment group, (collapsed) KLG, geographic region, and gender as factors, age and body mass index as covariates.||1.384|0.448|0.406
72625072|NCT02908178|144779748|OTHER||Hazard Ratio (HR)|1.03||||0.603|TWO_SIDED|99.0|0.71|1.51||P-value is unadjusted. Threshold for statistical significance is 0.01.|Chi-squared||Reference is no SLNB. Estimates are from matched cohort and adjusted for physician visits, any hospitalization in the 3-24 months prior to DCIS diagnosis, use of preoperative breast MRI, surgeon's operation volume, and receipt of radiation therapy.|Testing the association between use of sentinel lymph node biopsy (SLNB) and ipsilateral invasive breast cancer occurrence for the Aim 2 matched cohort.||1.51|0.71|0.603
72523265|NCT00565812|144576768|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.154||||0.591|TWO_SIDED|95.0|0.685|1.942|||Regression, Logistic|||Month 24; Odds ratio, 95 percent CI and P-values were obtained from a logistic regression model, with treatment group, (collapsed) KLG, geographic region, and gender as factors, age and body mass index as covariates.||1.942|0.685|0.591
72523266|NCT00565812|144576769|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.704||||0.168|TWO_SIDED|95.0|0.428|1.16|||Regression, Logistic|||Month 12; Odds ratio, 95 percent CI and P-values were obtained from a logistic regression model, with treatment group, (collapsed) KLG, geographic region, and gender as factors, age and body mass index as covariates.||1.160|0.428|0.168
72523267|NCT00565812|144576769|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.893||||0.634|TWO_SIDED|95.0|0.56|1.423|||Regression, Logistic|||Month 12; Odds ratio, 95 percent CI and P-values were obtained from a logistic regression model, with treatment group, (collapsed) KLG, geographic region, and gender as factors, age and body mass index as covariates.||1.423|0.560|0.634
72523268|NCT00565812|144576769|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.583||||0.032|TWO_SIDED|95.0|0.356|0.955|||Regression, Logistic|||Month 24; Odds ratio, 95 percent CI and P-values were obtained from a logistic regression model, with treatment group, (collapsed) KLG, geographic region, and gender as factors, age and body mass index as covariates.||0.955|0.356|0.032
72523269|NCT00565812|144576769|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.774||||0.276|TWO_SIDED|95.0|0.489|1.227|||Regression, Logistic|||Month 24; Odds ratio, 95 percent CI and P-values were obtained from a logistic regression model, with treatment group, (collapsed) KLG, geographic region, and gender as factors, age and body mass index as covariates.||1.227|0.489|0.276
72570663|NCT02504671|144670142|OTHER||Mean Difference (Net)|-13.94||||0.005|TWO_SIDED|95.0|-23.72|-4.16||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 8, Pain score|||-4.16|-23.72|0.005
72570664|NCT02504671|144670142|OTHER||Mean Difference (Net)|-7.02||||0.182|TWO_SIDED|95.0|-17.36|3.32||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, Pain score|||3.32|-17.36|0.182
72570665|NCT02504671|144670142|OTHER||Mean Difference (Net)|-14.15||||0.007|TWO_SIDED|95.0|-24.42|-3.87||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, Pain score|||-3.87|-24.42|0.007
72570666|NCT02504671|144670142|OTHER||Mean Difference (Net)|-18.18|||<|0.001|TWO_SIDED|95.0|-28.35|-8.01||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, Pain score|||-8.01|-28.35|<0.001
72570667|NCT02504671|144670142|OTHER||Mean Difference (Net)|-4.89||||0.527|TWO_SIDED|95.0|-20.15|10.36||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 16, Pain score|||10.36|-20.15|0.527
72406358|NCT02942017|144321622|SUPERIORITY||LS Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.082||0.3023|TWO_SIDED|95.0|-0.24|0.08|||MMRM|||Suicide, Hour 4:MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.08|-0.24|0.3023
72523270|NCT00565812|144576770|SUPERIORITY_OR_OTHER||LS mean difference|-0.03|STANDARD_ERROR_OF_MEAN|0.09||0.709|TWO_SIDED|95.0|-0.21|0.14|||ANCOVA|||LS Mean, 95 percent CI and P-values were obtained from an analysis of covariance (ANCOVA) model, with treatment group, (collapsed) KLG, geographic region, and gender as factors and age and body mass index as covariates.||0.14|-0.21|0.709
72570668|NCT02504671|144670142|OTHER||Mean Difference (Net)|-15.95||||0.034|TWO_SIDED|95.0|-30.72|-1.19||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 16, Pain score|||-1.19|-30.72|0.034
72570669|NCT02504671|144670142|OTHER||Mean Difference (Net)|-13.86||||0.062|TWO_SIDED|95.0|-28.42|0.7||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 16, Pain score|||0.70|-28.42|0.062
72570670|NCT02504671|144670142|OTHER||Mean Difference (Net)|-0.69||||0.924|TWO_SIDED|95.0|-14.85|13.47||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 20, Pain score|||13.47|-14.85|0.924
72570671|NCT02504671|144670142|OTHER||Mean Difference (Net)|-13.17||||0.058|TWO_SIDED|95.0|-26.82|0.48||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 20, Pain score|||0.48|-26.82|0.058
72570672|NCT02504671|144670142|OTHER||Mean Difference (Net)|-13.49||||0.049|TWO_SIDED|95.0|-26.91|-0.08||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 20, Pain score|||-0.08|-26.91|0.049
72570673|NCT02504671|144670142|OTHER||Mean Difference (Net)|-6.38||||0.445|TWO_SIDED|95.0|-22.84|10.07||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, Pain score|||10.07|-22.84|0.445
72570674|NCT02504671|144670142|OTHER||Mean Difference (Net)|-10.14||||0.205|TWO_SIDED|95.0|-25.87|5.58||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, Pain score|||5.58|-25.87|0.205
72570675|NCT02504671|144670142|OTHER||Mean Difference (Net)|-12.07||||0.125|TWO_SIDED|95.0|-27.55|3.41||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, Pain score|||3.41|-27.55|0.125
72570676|NCT02504671|144670142|OTHER||Mean Difference (Net)|-4.93||||0.187|TWO_SIDED|95.0|-12.26|2.41||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 1, Pain score|||2.41|-12.26|0.187
72570677|NCT02504671|144670142|OTHER||Mean Difference (Net)|-5.63||||0.13|TWO_SIDED|95.0|-12.93|1.67||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 1, Pain score|||1.67|-12.93|0.130
72523271|NCT00565812|144576770|SUPERIORITY_OR_OTHER||LS mean difference|0.02|STANDARD_ERROR_OF_MEAN|0.09||0.798|TWO_SIDED|95.0|-0.15|0.2|||ANCOVA|||LS-Mean, 95 percent CI and P-values were obtained from an ANCOVA model, with treatment group, (collapsed) KLG, geographic region, and gender as factors and age and body mass index as covariates.||0.20|-0.15|0.798
72523272|NCT00565812|144576771|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.032||||0.81|TWO_SIDED|95.0|0.797|1.337|||Regression, Logistic|||Odds ratio, 95 percent CI and P-values were obtained from a logistic regression model, with treatment group, (collapsed) KLG, geographic region, and gender as factors, baseline JSW, age and body mass index as covariates.||1.337|0.797|0.810
72570678|NCT02504671|144670142|OTHER||Mean Difference (Net)|-7.85||||0.051|TWO_SIDED|95.0|-15.72|0.03||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 2, Pain score|||0.03|-15.72|0.051
72570679|NCT02504671|144670142|OTHER||Mean Difference (Net)|-10.44||||0.009|TWO_SIDED|95.0|-18.27|-2.6||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 2, Pain score|||-2.60|-18.27|0.009
72570680|NCT02504671|144670142|OTHER||Mean Difference (Net)|-7.94||||0.068|TWO_SIDED|95.0|-16.47|0.58||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, Pain score|||0.58|-16.47|0.068
72570681|NCT02504671|144670142|OTHER||Mean Difference (Net)|-13.96||||0.001|TWO_SIDED|95.0|-22.47|-5.44||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, Pain score|||-5.44|-22.47|0.001
72570682|NCT02504671|144670142|OTHER||Mean Difference (Net)|-7.36||||0.118|TWO_SIDED|95.0|-16.62|1.89||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 6, Pain score|||1.89|-16.62|0.118
72523273|NCT00565812|144576771|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.068||||0.62|TWO_SIDED|95.0|0.824|1.383|||Regression, Logistic|||Odds ratio, 95 percent CI and P-values were obtained from a logistic regression model, with treatment group, (collapsed) KLG, geographic region, and gender as factors, baseline JSW, age and body mass index as covariates.||1.383|0.824|0.620
72523274|NCT00565812|144576772|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.745||||0.047|TWO_SIDED|95.0|0.557|0.997|||Regression, Logistic|||Odds ratio, 95 percent CI and P-values were obtained from a logistic regression model, with treatment group, (collapsed) KLG, geographic region, and gender as factors, age and body mass index as covariates.||0.997|0.557|0.047
72523275|NCT00565812|144576772|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.864||||0.317|TWO_SIDED|95.0|0.65|1.15|||Regression, Logistic|||Odds ratio, 95 percent CI and P-values were obtained from a logistic regression model, with treatment group, (collapsed) KLG, geographic region, and gender as factors, age and body mass index as covariates.||1.150|0.650|0.317
72523276|NCT00565812|144576773|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.043||||0.881|TWO_SIDED|95.0|0.602|1.806|||Regression, Logistic|||Odds ratio, 95 percent CI and P-values were obtained from a logistic regression model, with treatment group, (collapsed) KLG, geographic region, and gender as factors, age and body mass index as covariates.||1.806|0.602|0.881
72523277|NCT00565812|144576773|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.186||||0.525|TWO_SIDED|95.0|0.701|2.009|||Regression, Logistic|||Odds ratio, 95 percent CI and P-values were obtained from a logistic regression model, with treatment group, (collapsed) KLG, geographic region, and gender as factors, age and body mass index as covariates.||2.009|0.701|0.525
72523278|NCT00565812|144576777|SUPERIORITY_OR_OTHER||LS mean difference|-0.27|STANDARD_ERROR_OF_MEAN|0.63||0.668|TWO_SIDED|95.0|-1.5|0.96|||Mixed Models Analysis|||Week 2; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.96|-1.50|0.668
72523279|NCT00565812|144576777|SUPERIORITY_OR_OTHER||LS mean difference|0.62|STANDARD_ERROR_OF_MEAN|0.63||0.326|TWO_SIDED|95.0|-0.61|1.85|||Mixed Models Analysis|||Week 2; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.85|-0.61|0.326
72523280|NCT00565812|144576777|SUPERIORITY_OR_OTHER||LS mean difference|-0.27|STANDARD_ERROR_OF_MEAN|0.66||0.679|TWO_SIDED|95.0|-1.56|1.01|||Mixed Models Analysis|||Week 4; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.01|-1.56|0.679
72523281|NCT00565812|144576777|SUPERIORITY_OR_OTHER||LS mean difference|1.86|STANDARD_ERROR_OF_MEAN|0.66||0.005|TWO_SIDED|95.0|0.57|3.14|||Mixed Models Analysis|||Week 4; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||3.14|0.57|0.005
72523282|NCT00565812|144576777|SUPERIORITY_OR_OTHER||LS mean difference|0.6|STANDARD_ERROR_OF_MEAN|0.72||0.399|TWO_SIDED|95.0|-0.8|2.01|||Mixed Models Analysis|||Week 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.01|-0.80|0.399
72523283|NCT00565812|144576777|SUPERIORITY_OR_OTHER||LS mean difference|2.52|STANDARD_ERROR_OF_MEAN|0.71|<|0.001|TWO_SIDED|95.0|1.12|3.92|||Mixed Models Analysis|||Week 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||3.92|1.12|<0.001
72406359|NCT02942017|144321622|SUPERIORITY||LS Mean Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.082||0.4127|TWO_SIDED|95.0|-0.23|0.09|||MMRM|||Suicide, Hour 8:MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.09|-0.23|0.4127
72406360|NCT02942017|144321622|SUPERIORITY||LS Mean Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.082||0.2819|TWO_SIDED|95.0|-0.25|0.07|||MMRM|||Suicide, Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.07|-0.25|0.2819
72523284|NCT00565812|144576777|SUPERIORITY_OR_OTHER||LS mean difference|0.3|STANDARD_ERROR_OF_MEAN|0.7||0.668|TWO_SIDED|95.0|-1.08|1.68|||Mixed Models Analysis|||Week 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.68|-1.08|0.668
72523285|NCT00565812|144576777|SUPERIORITY_OR_OTHER||LS mean difference|1.76|STANDARD_ERROR_OF_MEAN|0.7||0.012|TWO_SIDED|95.0|0.39|3.13|||Mixed Models Analysis|||Week 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||3.13|0.39|0.012
72570683|NCT02504671|144670142|OTHER||Mean Difference (Net)|-12.43||||0.009|TWO_SIDED|95.0|-21.68|-3.19||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 6, Pain score|||-3.19|-21.68|0.009
72406361|NCT02942017|144321622|SUPERIORITY||LS Mean Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.082||0.3884|TWO_SIDED|95.0|-0.23|0.09|||MMRM|||Suicide, Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.09|-0.23|0.3884
72406362|NCT02942017|144321622|SUPERIORITY||LS Mean Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.082||0.275|TWO_SIDED|95.0|-0.25|0.07|||MMRM|||Suicide, Hour 36:MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.07|-0.25|0.2750
72406363|NCT02942017|144321622|SUPERIORITY||LS Mean Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.082||0.1811|TWO_SIDED|95.0|-0.27|0.05|||MMRM|||Suicide, Hour 48:MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.05|-0.27|0.1811
72406364|NCT02942017|144321622|SUPERIORITY||LS Mean Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.082||0.3854|TWO_SIDED|95.0|-0.23|0.09|||MMRM|||Suicide, Hour 60:MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.09|-0.23|0.3854
72523286|NCT00565812|144576777|SUPERIORITY_OR_OTHER||LS mean difference|1.2|STANDARD_ERROR_OF_MEAN|0.75||0.109|TWO_SIDED|95.0|-0.27|2.67|||Mixed Models Analysis|||Week 36; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group x visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.67|-0.27|0.109
72523287|NCT00565812|144576777|SUPERIORITY_OR_OTHER||LS mean difference|1.03|STANDARD_ERROR_OF_MEAN|0.74||0.163|TWO_SIDED|95.0|-0.42|2.48|||Mixed Models Analysis|||Week 36; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.48|-0.42|0.163
72523288|NCT00565812|144576777|SUPERIORITY_OR_OTHER||LS mean difference|-0.58|STANDARD_ERROR_OF_MEAN|0.73||0.424|TWO_SIDED|95.0|-2.02|0.85|||Mixed Models Analysis|||Week 48; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.85|-2.02|0.424
72523289|NCT00565812|144576777|SUPERIORITY_OR_OTHER||LS mean difference|0.34|STANDARD_ERROR_OF_MEAN|0.72||0.635|TWO_SIDED|95.0|-1.07|1.76|||Mixed Models Analysis|||Week 48; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.76|-1.07|0.635
72523290|NCT00565812|144576777|SUPERIORITY_OR_OTHER||LS mean difference|0.14|STANDARD_ERROR_OF_MEAN|0.75||0.855|TWO_SIDED|95.0|-1.34|1.61|||Mixed Models Analysis|||Week 60; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.61|-1.34|0.855
72523291|NCT00565812|144576777|SUPERIORITY_OR_OTHER||LS mean difference|1.84|STANDARD_ERROR_OF_MEAN|0.74||0.013|TWO_SIDED|95.0|0.38|3.3|||Mixed Models Analysis|||Week 60; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||3.30|0.38|0.013
72523292|NCT00565812|144576777|SUPERIORITY_OR_OTHER||LS mean difference|-0.85|STANDARD_ERROR_OF_MEAN|0.81||0.292|TWO_SIDED|95.0|-2.44|0.73|||Mixed Models Analysis|||Week 72; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.73|-2.44|0.292
72523293|NCT00565812|144576777|SUPERIORITY_OR_OTHER||LS mean difference|0.1|STANDARD_ERROR_OF_MEAN|0.8||0.897|TWO_SIDED|95.0|-1.47|1.68|||Mixed Models Analysis|||Week 72; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.68|-1.47|0.897
72570684|NCT02504671|144670142|OTHER||Mean Difference (Net)|-16.51||||0.001|TWO_SIDED|95.0|-26.38|-6.65||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 8, Pain score|||-6.65|-26.38|0.001
72523294|NCT00565812|144576777|SUPERIORITY_OR_OTHER||LS mean difference|-0.72|STANDARD_ERROR_OF_MEAN|0.84||0.39|TWO_SIDED|95.0|-2.36|0.92|||Mixed Models Analysis|||Week 84; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.92|-2.36|0.390
72570685|NCT02504671|144670142|OTHER||Mean Difference (Net)|-20.39|||<|0.001|TWO_SIDED|95.0|-30.27|-10.52||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 8, Pain score|||-10.52|-30.27|<0.001
72523295|NCT00565812|144576777|SUPERIORITY_OR_OTHER||LS mean difference|0.37|STANDARD_ERROR_OF_MEAN|0.83||0.659|TWO_SIDED|95.0|-1.26|1.99|||Mixed Models Analysis|||Week 84; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.99|-1.26|0.659
72523296|NCT00565812|144576777|SUPERIORITY_OR_OTHER||LS mean difference|-0.16|STANDARD_ERROR_OF_MEAN|0.8||0.847|TWO_SIDED|95.0|-1.73|1.42|||Mixed Models Analysis|||Week 96; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.42|-1.73|0.847
72523297|NCT00565812|144576777|SUPERIORITY_OR_OTHER||LS mean difference|0.77|STANDARD_ERROR_OF_MEAN|0.8||0.333|TWO_SIDED|95.0|-0.79|2.34|||Mixed Models Analysis|||Week 96; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.34|-0.79|0.333
72523298|NCT00565812|144576778|SUPERIORITY_OR_OTHER||LS mean difference|-0.49|STANDARD_ERROR_OF_MEAN|0.42||0.238|TWO_SIDED|95.0|-1.31|0.32|||Mixed Models Analysis|||Week 2; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.32|-1.31|0.238
72523299|NCT00565812|144576778|SUPERIORITY_OR_OTHER||LS mean difference|0.1|STANDARD_ERROR_OF_MEAN|0.41||0.815|TWO_SIDED|95.0|-0.72|0.91|||Mixed Models Analysis|||Week 2; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.91|-0.72|0.815
72625073|NCT02908178|144779749|OTHER||Hazard Ratio (HR)|1.17||||0.62|TWO_SIDED|99.0|0.81|1.69||P-value is unadjusted. Threshold for statistical significance is 0.01.|Chi-squared||Reference is no SLNB. Estimates are from matched cohort and adjusted for physician visits, any hospitalization in the 3-24 months prior to DCIS diagnosis, use of preoperative breast MRI, surgeon's operation volume, and receipt of radiation therapy.|Testing the association between use of sentinel lymph node biopsy (SLNB) and treated recurrence in the Aim 2 matched cohort.||1.69|0.81|0.620
72625074|NCT03773484|144779750|OTHER||Slope|-0.008|STANDARD_ERROR_OF_MEAN|0.011||0.43|TWO_SIDED|95.0|-0.03|0.01|||Mixed Models Analysis|||Pre post comparison for Opioid Naïve patients||0.01|-0.03|0.43
72625075|NCT03773484|144779750|OTHER||Slope|-0.019|STANDARD_ERROR_OF_MEAN|0.016||0.24|TWO_SIDED|95.0|-0.051|0.013|||Mixed Models Analysis|||Pre-post comparison for at-risk for long term use patients||0.013|-0.051|0.24
72625076|NCT03211416|144779775|SUPERIORITY||Response Rate|0.296|||||TWO_SIDED|95.0|0.151|0.483||||||||0.483|0.151|
72625077|NCT03211416|144779778|SUPERIORITY|||||||0.4||||||Significance level of 0.05.|Two-sided, one-sample t-test|||The null hypothesis is that the mean ratio of T effect cells (post / pre) is equal to 1 (no change).||||0.40
72625078|NCT02302222|144779786|SUPERIORITY||Risk Difference (RD)|0.113||||0.1981|TWO_SIDED|95.0|-0.016|0.243|||Fisher Exact|||||0.243|-0.016|0.1981
72625079|NCT03781570|144779810|SUPERIORITY||Mean Difference (Final Values)|-0.0544|STANDARD_ERROR_OF_MEAN|0.00517|<|0.001|TWO_SIDED|95.0|-0.0648|-0.0441|||Mixed Models Analysis|Satterthwaite's method was used to estimate degrees of freedom for the mixed effects model.||Comparing placebo vs. control for thermal pain ratings with mixed effects models controlling for the stimulus intensity and the familial structure of the data.||-0.0441|-0.0648|<0.001
72625080|NCT01107496|144779812|SUPERIORITY||Median Difference (Net)|6.0||||0.0414|TWO_SIDED|95.0|1.0|12.0|||Wilcoxon (Mann-Whitney)|||This analysis applies to Week 6 data.||12.00|1.00|0.0414
72625081|NCT01107496|144779813|SUPERIORITY||Median Difference (Net)|3.0||||0.0803|TWO_SIDED|95.0|0.0|7.0|||Wilcoxon (Mann-Whitney)|||This analysis applies to Week 1 data.||7.00|0.00|0.0803
72625082|NCT01107496|144779814|SUPERIORITY||Median Difference (Net)|0.0||||0.5308|TWO_SIDED|95.0|-1.0|1.0|||Wilcoxon (Mann-Whitney)|||This analysis pertains to Week 1 data.||1.00|-1.00|0.5308
72625083|NCT01107496|144779814|SUPERIORITY||Median Difference (Net)|-1.0||||0.2032|TWO_SIDED|95.0|-2.0|0.0|||Wilcoxon (Mann-Whitney)|||This analysis pertains to Week 2 data.||0.00|-2.00|0.2032
72625084|NCT01107496|144779814|SUPERIORITY||Median Difference (Net)|-1.0||||0.0677|TWO_SIDED|95.0|-2.0|0.0|||Wilcoxon (Mann-Whitney)|||This analysis pertains to Week 3 data.||0.00|-2.00|0.0677
72625085|NCT01107496|144779814|SUPERIORITY||Median Difference (Net)|-1.0||||0.0743|TWO_SIDED|95.0|-2.0|0.0|||Wilcoxon (Mann-Whitney)|||This analysis pertains to Week 4 data.||0.00|-2.00|0.0743
72625086|NCT01107496|144779814|SUPERIORITY||Median Difference (Net)|-1.0||||0.0437|TWO_SIDED|95.0|-2.0|0.0|||Wilcoxon (Mann-Whitney)|||This analysis pertains to Week 5 data.||0.00|-2.00|0.0437
72625087|NCT01107496|144779814|SUPERIORITY||Median Difference (Net)|-1.0||||0.1209|TWO_SIDED|95.0|-2.0|0.0|||Wilcoxon (Mann-Whitney)|||This analysis applies to Week 6 data.||0.00|-2.00|0.1209
72625088|NCT01107496|144779815|SUPERIORITY||Median Difference (Net)|1.0||||0.6022|TWO_SIDED|95.0|-4.0|6.0|||Wilcoxon (Mann-Whitney)|||This analysis applies to Week 2 data.||6.00|-4.00|0.6022
72625089|NCT01107496|144779815|SUPERIORITY||Median Difference (Net)|-4.0||||0.0794|TWO_SIDED|95.0|-10.0|1.0|||Wilcoxon (Mann-Whitney)|||This analysis applies to Week 3 data.||1.00|-10.0|0.0794
72625090|NCT01107496|144779815|SUPERIORITY||Median Difference (Net)|-6.0||||0.0747|TWO_SIDED|95.0|-10.0|0.0|||Wilcoxon (Mann-Whitney)|||This analysis applies to Week 4 data.||0.00|-10.0|0.0747
72625091|NCT01107496|144779815|SUPERIORITY||Median Difference (Net)|-6.5||||0.0545|TWO_SIDED|95.0|-12.0|0.0|||Wilcoxon (Mann-Whitney)|||This analysis applies to Week 5 data.||0.00|-12.0|0.0545
72523300|NCT00565812|144576778|SUPERIORITY_OR_OTHER||LS mean difference|0.28|STANDARD_ERROR_OF_MEAN|0.42||0.508|TWO_SIDED|95.0|-0.54|1.1|||Mixed Models Analysis|||Week 4; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.10|-0.54|0.508
72523301|NCT00565812|144576778|SUPERIORITY_OR_OTHER||LS mean difference|1.2|STANDARD_ERROR_OF_MEAN|0.42||0.004|TWO_SIDED|95.0|0.38|2.02|||Mixed Models Analysis|||Week 4; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.02|0.38|0.004
72523302|NCT00565812|144576778|SUPERIORITY_OR_OTHER||LS mean difference|-0.18|STANDARD_ERROR_OF_MEAN|0.45||0.683|TWO_SIDED|95.0|-1.07|0.7|||Mixed Models Analysis|||Week 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.70|-1.07|0.683
72523303|NCT00565812|144576778|SUPERIORITY_OR_OTHER||LS mean difference|1.21|STANDARD_ERROR_OF_MEAN|0.45||0.007|TWO_SIDED|95.0|0.33|2.09|||Mixed Models Analysis|||Week 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.09|0.33|0.007
72523304|NCT00565812|144576778|SUPERIORITY_OR_OTHER||LS mean difference|0.18|STANDARD_ERROR_OF_MEAN|0.45||0.687|TWO_SIDED|95.0|-0.71|1.07|||Mixed Models Analysis|||Week 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.07|-0.71|0.687
72523305|NCT00565812|144576778|SUPERIORITY_OR_OTHER||LS mean difference|0.89|STANDARD_ERROR_OF_MEAN|0.45||0.05|TWO_SIDED|95.0|0.0|1.78|||Mixed Models Analysis|||Week 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.78|-0.00|0.050
72523306|NCT00565812|144576778|SUPERIORITY_OR_OTHER||LS mean difference|0.6|STANDARD_ERROR_OF_MEAN|0.48||0.215|TWO_SIDED|95.0|-0.35|1.54|||Mixed Models Analysis|||Week 36; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.54|-0.35|0.215
72625092|NCT01107496|144779816|SUPERIORITY||Median Difference (Net)|7.0||||0.0349|TWO_SIDED|95.0|1.0|13.0|||Wilcoxon (Mann-Whitney)|||This analysis applies to Week 6 data.||13.00|1.00|0.0349
72406365|NCT02942017|144321622|SUPERIORITY||LS Mean Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.082||0.3822|TWO_SIDED|95.0|-0.23|0.09|||MMRM|||Suicide, Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.09|-0.23|0.3822
72406366|NCT02942017|144321622|SUPERIORITY||LS Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.082||0.9255|TWO_SIDED|95.0|-0.17|0.15|||MMRM|||Suicide, Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.15|-0.17|0.9255
72523307|NCT00565812|144576778|SUPERIORITY_OR_OTHER||LS mean difference|0.96|STANDARD_ERROR_OF_MEAN|0.47||0.042|TWO_SIDED|95.0|0.03|1.89|||Mixed Models Analysis|||Week 36; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.89|0.03|0.042
72523308|NCT00565812|144576778|SUPERIORITY_OR_OTHER||LS mean difference|-0.42|STANDARD_ERROR_OF_MEAN|0.5||0.401|TWO_SIDED|95.0|-1.41|0.56|||Mixed Models Analysis|||Week 48; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.56|-1.41|0.401
72523309|NCT00565812|144576778|SUPERIORITY_OR_OTHER||LS mean difference|0.01|STANDARD_ERROR_OF_MEAN|0.5||0.98|TWO_SIDED|95.0|-0.96|0.99|||Mixed Models Analysis|||Week 48; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.99|-0.96|0.980
72523310|NCT00565812|144576778|SUPERIORITY_OR_OTHER||LS mean difference|-0.24|STANDARD_ERROR_OF_MEAN|0.51||0.632|TWO_SIDED|95.0|-1.25|0.76|||Mixed Models Analysis|||Week 60; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.76|-1.25|0.632
72625093|NCT01107496|144779817|SUPERIORITY||Median Difference (Net)|-0.5||||0.4038|TWO_SIDED|95.0|-1.0|0.0|||Wilcoxon rank-sum test|||Analysis pertains to Week 1 data||0.00|-1.00|0.4038
72625094|NCT01107496|144779817|SUPERIORITY||Median Difference (Net)|-0.5||||0.446|TWO_SIDED|95.0|-1.0|0.0|||Wilcoxon rank-sum test|||Analysis pertains to Week 2 data||0.00|-1.00|0.4460
72523311|NCT00565812|144576778|SUPERIORITY_OR_OTHER||LS mean difference|1.08|STANDARD_ERROR_OF_MEAN|0.51||0.032|TWO_SIDED|95.0|0.09|2.07|||Mixed Models Analysis|||Week 60; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.07|0.09|0.032
72523312|NCT00565812|144576778|SUPERIORITY_OR_OTHER||LS mean difference|-0.23|STANDARD_ERROR_OF_MEAN|0.54||0.668|TWO_SIDED|95.0|-1.29|0.83|||Mixed Models Analysis|||Week 72; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.83|-1.29|0.668
72523313|NCT00565812|144576778|SUPERIORITY_OR_OTHER||LS mean difference|1.11|STANDARD_ERROR_OF_MEAN|0.54||0.038|TWO_SIDED|95.0|0.06|2.16|||Mixed Models Analysis|||Week 72; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.16|0.06|0.038
72523314|NCT00565812|144576778|SUPERIORITY_OR_OTHER||LS mean difference|-0.09|STANDARD_ERROR_OF_MEAN|0.53||0.868|TWO_SIDED|95.0|-1.13|0.95|||Mixed Models Analysis|||Week 84; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.95|-1.13|0.868
72523315|NCT00565812|144576778|SUPERIORITY_OR_OTHER||LS mean difference|0.59|STANDARD_ERROR_OF_MEAN|0.52||0.257|TWO_SIDED|95.0|-0.43|1.62|||Mixed Models Analysis|||Week 84; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.62|-0.43|0.257
72523316|NCT00565812|144576778|SUPERIORITY_OR_OTHER||LS mean difference|0.07|STANDARD_ERROR_OF_MEAN|0.55||0.895|TWO_SIDED|95.0|-1.0|1.15|||Mixed Models Analysis|||Week 96; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.15|-1.00|0.895
72523317|NCT00565812|144576778|SUPERIORITY_OR_OTHER||LS mean difference|0.6|STANDARD_ERROR_OF_MEAN|0.54||0.268|TWO_SIDED|95.0|-0.46|1.67|||Mixed Models Analysis|||Week 96; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.67|-0.46|0.268
72523318|NCT00565812|144576779|SUPERIORITY_OR_OTHER||LS mean difference|-0.05|STANDARD_ERROR_OF_MEAN|0.44||0.908|TWO_SIDED|95.0|-0.92|0.82|||Mixed Models Analysis|||Week 2; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.82|-0.92|0.908
72523319|NCT00565812|144576779|SUPERIORITY_OR_OTHER||LS mean difference|-1.18|STANDARD_ERROR_OF_MEAN|0.44||0.008|TWO_SIDED|95.0|-2.05|-0.31|||Mixed Models Analysis|||Week 2; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||-0.31|-2.05|0.008
72523320|NCT00565812|144576779|SUPERIORITY_OR_OTHER||LS mean difference|-0.35|STANDARD_ERROR_OF_MEAN|0.46||0.44|TWO_SIDED|95.0|-1.25|0.54|||Mixed Models Analysis|||Week 4; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.54|-1.25|0.440
72523321|NCT00565812|144576779|SUPERIORITY_OR_OTHER||LS mean difference|-0.67|STANDARD_ERROR_OF_MEAN|0.46||0.14|TWO_SIDED|95.0|-1.57|0.22|||Mixed Models Analysis|||Week 4; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.22|-1.57|0.140
72523322|NCT00565812|144576779|SUPERIORITY_OR_OTHER||LS mean difference|0.33|STANDARD_ERROR_OF_MEAN|0.46||0.474|TWO_SIDED|95.0|-0.58|1.24|||Mixed Models Analysis|||Week 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.24|-0.58|0.474
72570686|NCT02504671|144670142|OTHER||Mean Difference (Net)|-12.0||||0.022|TWO_SIDED|95.0|-22.27|-1.73||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, Pain score|||-1.73|-22.27|0.022
72406367|NCT02942017|144321622|SUPERIORITY||LS Mean Difference|0.04|STANDARD_ERROR_OF_MEAN|0.091||0.6714|TWO_SIDED|95.0|-0.14|0.22|||MMRM|||Suicide, Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.22|-0.14|0.6714
72406368|NCT02942017|144321622|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.091||0.9838|TWO_SIDED|95.0|-0.18|0.18|||MMRM|||Suicide, Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.18|-0.18|0.9838
72406369|NCT02942017|144321622|SUPERIORITY||LS Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.083||0.8884|TWO_SIDED|95.0|-0.17|0.15|||MMRM|||Suicide, Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.15|-0.17|0.8884
72406370|NCT02942017|144321622|SUPERIORITY||LS Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.097||0.6996|TWO_SIDED|95.0|-0.23|0.16|||MMRM|||Insomnia-Early, Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.16|-0.23|0.6996
72406371|NCT02942017|144321622|SUPERIORITY||LS Mean Difference|0.09|STANDARD_ERROR_OF_MEAN|0.121||0.4426|TWO_SIDED|95.0|-0.15|0.33|||MMRM|||Insomnia-Early, Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.33|-0.15|0.4426
72406372|NCT02942017|144321622|SUPERIORITY||LS Mean Difference|0.02|STANDARD_ERROR_OF_MEAN|0.11||0.8743|TWO_SIDED|95.0|-0.2|0.24|||MMRM|||Insomnia-Early, Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.24|-0.20|0.8743
72406373|NCT02942017|144321622|SUPERIORITY||LS Mean Difference|0.11|STANDARD_ERROR_OF_MEAN|0.118||0.3498|TWO_SIDED|95.0|-0.12|0.35|||MMRM|||Insomnia-Early, Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.35|-0.12|0.3498
72406374|NCT02942017|144321622|SUPERIORITY||LS Mean Difference|-0.26|STANDARD_ERROR_OF_MEAN|0.151||0.0839|TWO_SIDED|95.0|-0.56|0.04|||MMRM|||Insomnia-Early, Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.04|-0.56|0.0839
72523323|NCT00565812|144576779|SUPERIORITY_OR_OTHER||LS mean difference|-0.41|STANDARD_ERROR_OF_MEAN|0.46||0.376|TWO_SIDED|95.0|-1.32|0.5|||Mixed Models Analysis|||Week 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.50|-1.32|0.376
72523324|NCT00565812|144576779|SUPERIORITY_OR_OTHER||LS mean difference|0.66|STANDARD_ERROR_OF_MEAN|0.5||0.186|TWO_SIDED|95.0|-0.32|1.64|||Mixed Models Analysis|||Week 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.64|-0.32|0.186
72523325|NCT00565812|144576779|SUPERIORITY_OR_OTHER||LS mean difference|-0.66|STANDARD_ERROR_OF_MEAN|0.5||0.185|TWO_SIDED|95.0|-1.63|0.32|||Mixed Models Analysis|||Week 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.32|-1.63|0.185
72406375|NCT02942017|144321622|SUPERIORITY||LS Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.157||0.2595|TWO_SIDED|95.0|-0.49|0.13|||MMRM|||Insomnia-Early, Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.13|-0.49|0.2595
72570687|NCT02504671|144670142|OTHER||Mean Difference (Net)|-17.94|||<|0.001|TWO_SIDED|95.0|-28.18|-7.7||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, Pain score|||-7.70|-28.18|<0.001
72570688|NCT02504671|144670142|OTHER||Mean Difference (Net)|-13.2||||0.084|TWO_SIDED|95.0|-28.18|1.79||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 16, Pain score|||1.79|-28.18|0.084
72523326|NCT00565812|144576779|SUPERIORITY_OR_OTHER||LS mean difference|-0.51|STANDARD_ERROR_OF_MEAN|0.52||0.334|TWO_SIDED|95.0|-1.53|0.52|||Mixed Models Analysis|||Week 36; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.52|-1.53|0.334
72523327|NCT00565812|144576779|SUPERIORITY_OR_OTHER||LS mean difference|-0.99|STANDARD_ERROR_OF_MEAN|0.52||0.055|TWO_SIDED|95.0|-2.0|0.02|||Mixed Models Analysis|||Week 36; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.02|-2.00|0.055
72523328|NCT00565812|144576779|SUPERIORITY_OR_OTHER||LS mean difference|-0.33|STANDARD_ERROR_OF_MEAN|0.54||0.539|TWO_SIDED|95.0|-1.38|0.72|||Mixed Models Analysis|||Week 48; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.72|-1.38|0.539
72523329|NCT00565812|144576779|SUPERIORITY_OR_OTHER||LS mean difference|-1.26|STANDARD_ERROR_OF_MEAN|0.53||0.018|TWO_SIDED|95.0|-2.3|-0.22|||Mixed Models Analysis|||Week 48; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||-0.22|-2.30|0.018
72523330|NCT00565812|144576779|SUPERIORITY_OR_OTHER||LS mean difference|-0.48|STANDARD_ERROR_OF_MEAN|0.53||0.365|TWO_SIDED|95.0|-1.52|0.56|||Mixed Models Analysis|||Week 60; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.56|-1.52|0.365
72523331|NCT00565812|144576779|SUPERIORITY_OR_OTHER||LS mean difference|-0.44|STANDARD_ERROR_OF_MEAN|0.52||0.403|TWO_SIDED|95.0|-1.47|0.59|||Mixed Models Analysis|||Week 60; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.59|-1.47|0.403
72523332|NCT00565812|144576779|SUPERIORITY_OR_OTHER||LS mean difference|-1.32|STANDARD_ERROR_OF_MEAN|0.57||0.02|TWO_SIDED|95.0|-2.43|-0.21|||Mixed Models Analysis|||Week 72; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||-0.21|-2.43|0.020
72523333|NCT00565812|144576779|SUPERIORITY_OR_OTHER||LS mean difference|-1.87|STANDARD_ERROR_OF_MEAN|0.56|<|0.001|TWO_SIDED|95.0|-2.98|-0.77|||Mixed Models Analysis|||Week 72; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||-0.77|-2.98|<0.001
72523334|NCT00565812|144576779|SUPERIORITY_OR_OTHER||LS mean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.54||0.269|TWO_SIDED|95.0|-1.66|0.46|||Mixed Models Analysis|||Week 84; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.46|-1.66|0.269
72570689|NCT02504671|144670142|OTHER||Mean Difference (Net)|-11.87||||0.099|TWO_SIDED|95.0|-26.02|2.27||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 16, Pain score|||2.27|-26.02|0.099
72570690|NCT02504671|144670142|OTHER||Mean Difference (Net)|-13.91||||0.048|TWO_SIDED|95.0|-27.68|-0.14||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 20, Pain score|||-0.14|-27.68|0.048
72523335|NCT00565812|144576779|SUPERIORITY_OR_OTHER||LS mean difference|-0.87|STANDARD_ERROR_OF_MEAN|0.54||0.104|TWO_SIDED|95.0|-1.92|0.18|||Mixed Models Analysis|||Week 84; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.18|-1.92|0.104
72570691|NCT02504671|144670142|OTHER||Mean Difference (Net)|-13.22||||0.048|TWO_SIDED|95.0|-26.32|-0.13||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 20, Pain score|||-0.13|-26.32|0.048
72570692|NCT02504671|144670142|OTHER||Mean Difference (Net)|-13.23||||0.102|TWO_SIDED|95.0|-29.11|2.64||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, Pain score|||2.64|-29.11|0.102
72625095|NCT01107496|144779817|SUPERIORITY||Median Difference (Net)|-0.5||||0.0549|TWO_SIDED|95.0|-1.0|0.0|||Wilcoxon rank-sum test|||Analysis pertains to Week 3 data||0.00|-1.00|0.0549
72625096|NCT01107496|144779817|SUPERIORITY||Median Difference (Net)|-0.5||||0.0759|TWO_SIDED|95.0|-1.0|0.0|||Wilcoxon rank-sum test|||Analysis pertains to Week 4 data||0.00|-1.00|0.0759
72625097|NCT01107496|144779817|SUPERIORITY||Median Difference (Net)|-0.5||||0.0342|TWO_SIDED|95.0|-1.0|0.0|||Wilcoxon rank-sum test|||Analysis pertains to Week 5 data||0.00|-1.00|0.0342
72625098|NCT01107496|144779817|SUPERIORITY||Median Difference (Net)|-1.0||||0.0474|TWO_SIDED||||||Wilcoxon rank-sum test|||Analysis pertains to Week 6 data||||0.0474
72625099|NCT05318287|144779838|EQUIVALENCE|Whether change in linear slope from pretest through the 8-week follow-up is equivalent to zero (null hypothesis).|Slope|-0.05|STANDARD_ERROR_OF_MEAN|0.03||0.083|TWO_SIDED||||||t-test, 2 sided|||||||.083
72523336|NCT00565812|144576779|SUPERIORITY_OR_OTHER||LS mean difference|-1.18|STANDARD_ERROR_OF_MEAN|0.57||0.038|TWO_SIDED|95.0|-2.3|-0.06|||Mixed Models Analysis|||Week 96; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||-0.06|-2.30|0.038
72523337|NCT00565812|144576779|SUPERIORITY_OR_OTHER||LS mean difference|-1.16|STANDARD_ERROR_OF_MEAN|0.57||0.041|TWO_SIDED|95.0|-2.28|-0.05|||Mixed Models Analysis|||Week 96; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||-0.05|-2.28|0.041
72523338|NCT02667392|144576784|OTHER|||||||0.77||||||a priori threshold for statistical significance set at p \< 0.05|t-test, 2 sided|||||||0.77
72523339|NCT02667392|144576785|OTHER|||||||0.61||||||a priori threshold for statistical significance set at p \< 0.05|t-test, 2 sided|||||||0.61
72523340|NCT02667392|144576786|OTHER|||||||0.28||||||a priori threshold for statistical significance set at p \< 0.05|t-test, 2 sided|||||||0.28
72523341|NCT02667392|144576787|OTHER|||||||0.002||||||a priori threshold for statistical significance set at p \< 0.05|t-test, 2 sided|||||||0.002
72523342|NCT02667392|144576788|OTHER|||||||0.02||||||a priori threshold for statistical significance set at p \< 0.05|t-test, 2 sided|||||||0.02
72570693|NCT02504671|144670142|OTHER||Mean Difference (Net)|-16.7||||0.03|TWO_SIDED|95.0|-31.79|-1.62||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, Pain score|||-1.62|-31.79|0.030
72570694|NCT02504671|144670143|OTHER||Mean Difference (Net)|0.6||||0.683|TWO_SIDED|95.0|-2.31|3.52||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, PCS|||3.52|-2.31|0.683
72406376|NCT02942017|144321622|SUPERIORITY||LS Mean Difference|-0.32|STANDARD_ERROR_OF_MEAN|0.168||0.056|TWO_SIDED|95.0|-0.66|0.01|||MMRM|||Insomnia-Early, Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.01|-0.66|0.0560
72523343|NCT02667392|144576789|OTHER|||||||0.03||||||a priori threshold for statistical significance set at p \< 0.05|t-test, 2 sided|||||||0.03
72523344|NCT02667392|144576790|OTHER|||||||0.55||||||a priori threshold for statistical significance set at p \< 0.05|t-test, 2 sided|||||||0.55
72523345|NCT02667392|144576791|OTHER|a priori threshold for statistical significance set at p \< 0.05||||||0.0089|||||||t-test, 2 sided|||||||0.0089
72523346|NCT02667392|144576792|OTHER|a priori threshold for statistical significance set at p \< 0.05||||||0.73|||||||t-test, 2 sided|||||||0.73
72523347|NCT02667392|144576793|OTHER|a priori threshold for statistical significance set at p \< 0.05||||||0.81|||||||t-test, 2 sided|||||||0.81
72523348|NCT02667392|144576794|OTHER|||||||0.02||||||a priori threshold for statistical significance set at p \< 0.05|t-test, 2 sided|||||||0.02
72523349|NCT02033850|144576795|SUPERIORITY|||||||0.145|||||||t-test, 2 sided|||Δs on ADL (baseline vs 6 months)||||.145
72523350|NCT02033850|144576795|SUPERIORITY|||||||0.618|||||||t-test, 2 sided|||Δs on ADL (6 vs 12 months)||||.618
72523351|NCT02033850|144576795|SUPERIORITY|||||||0.262|||||||t-test, 2 sided|||Δs on ADL (baseline vs 12 months)||||.262
72523352|NCT02033850|144576795|SUPERIORITY|||||||0.24|||||||t-test, 2 sided|||Δs on IADL (baseline vs 6 months)||||.240
72523353|NCT02033850|144576795|SUPERIORITY|||||||0.134|||||||t-test, 2 sided|||Δs on IADL (6 vs 12 months)||||.134
72523354|NCT02033850|144576795|SUPERIORITY|||||||0.457|||||||t-test, 2 sided|||Δs on IADL (baseline vs 12 months)||||.457
72523355|NCT02033850|144576795|SUPERIORITY|||||||0.612|||||||t-test, 2 sided|||Δs on DAD (baseline vs 6 months)||||.612
72523356|NCT02033850|144576795|SUPERIORITY|||||||0.522|||||||t-test, 2 sided|||Δs on DAD (6 vs 12 months)||||.522
72523357|NCT02033850|144576795|SUPERIORITY|||||||0.8|||||||t-test, 2 sided|||Δs on DAD (baseline vs 12 months)||||.800
72523358|NCT02033850|144576796|SUPERIORITY|||||||0.204|||||||t-test, 2 sided|||Δs on AQ (baseline vs 6 months)||||.204
72523359|NCT02033850|144576796|SUPERIORITY|||||||0.81|||||||t-test, 2 sided|||Δs on AQ (6 vs 12 months)||||.810
72523360|NCT02033850|144576796|SUPERIORITY|||||||0.193|||||||t-test, 2 sided|||Δs on AQ (baseline vs 12 months)||||.193
72523361|NCT02033850|144576796|SUPERIORITY|||||||0.698|||||||t-test, 2 sided|||Δs on EQ index (baseline vs 6 months)||||.698
72523362|NCT02033850|144576796|SUPERIORITY|||||||0.283|||||||t-test, 2 sided|||Δs on EQ index (6 vs 12 months)||||.283
72523363|NCT02033850|144576796|SUPERIORITY|||||||0.647|||||||t-test, 2 sided|||Δs on EQ index (baseline vs 12 months)||||.647
72523364|NCT02033850|144576796|SUPERIORITY|||||||0.057|||||||t-test, 2 sided|||Δs on EQ visual (baseline vs 6 months)||||.057
72523365|NCT02033850|144576796|SUPERIORITY|||||||0.685|||||||t-test, 2 sided|||Δs on EQ visual (6 vs 12 months)||||.685
72523366|NCT02033850|144576796|SUPERIORITY|||||||0.056|||||||t-test, 2 sided|||Δs on EQ visual (baseline vs 12 months)||||.056
72523367|NCT02033850|144576796|SUPERIORITY|||||||0.393|||||||t-test, 2 sided|||Δs on GDS (baseline vs 6 months)||||.393
72523368|NCT02033850|144576796|SUPERIORITY|||||||0.958|||||||t-test, 2 sided|||Δs on GDS (6 vs 12 months)||||.958
72523369|NCT02033850|144576796|SUPERIORITY|||||||0.448|||||||t-test, 2 sided|||Δs on GDS (baseline vs 12 months)||||.448
72523370|NCT02033850|144576796|SUPERIORITY|||||||0.567|||||||t-test, 2 sided|||Δs on MCS (baseline vs 6 months)||||.567
72523371|NCT02033850|144576796|SUPERIORITY|||||||0.274|||||||t-test, 2 sided|||Δs on MCS (6 vs 12 months)||||.274
72523372|NCT02033850|144576796|SUPERIORITY|||||||0.668|||||||t-test, 2 sided|||Δs on MCS (baseline vs 12 months)||||.668
72570695|NCT02504671|144670143|OTHER||Mean Difference (Net)|3.19||||0.03|TWO_SIDED|95.0|0.31|6.07||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, PCS|||6.07|0.31|0.030
72570696|NCT02504671|144670143|OTHER||Mean Difference (Net)|2.61||||0.074|TWO_SIDED|95.0|-0.25|5.47||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, PCS|||5.47|-0.25|0.074
72523373|NCT02033850|144576796|SUPERIORITY|||||||0.709|||||||t-test, 2 sided|||Δs on PCS (baseline vs 6 months)||||.709
72625100|NCT05318287|144779839|EQUIVALENCE|Whether change in linear slope from pretest through the 8-week follow-up is equivalent to zero (null hypothesis).|Slope|-0.04|STANDARD_ERROR_OF_MEAN|0.02||0.01|TWO_SIDED||||||t-test, 2 sided|||||||.010
72523374|NCT02033850|144576796|SUPERIORITY|||||||0.567|||||||t-test, 2 sided|||Δs on PCS (6 vs 12 months)||||.567
72523375|NCT02033850|144576796|SUPERIORITY|||||||0.867|||||||t-test, 2 sided|||Δs on PCS (baseline vs 12 months)||||.867
72523376|NCT02033850|144576797|SUPERIORITY|||||||0.095|||||||Chi-squared|||MCS outcome (baseline vs 6 months)||||.095
72523377|NCT02033850|144576797|SUPERIORITY|||||||0.729|||||||Chi-squared|||MCS outcome (6 vs 12 months)||||.729
72523378|NCT02033850|144576797|SUPERIORITY|||||||0.115|||||||Chi-squared|||MCS outcome (baseline vs 12 months)||||.115
72523379|NCT02033850|144576797|SUPERIORITY|||||||0.576|||||||Chi-squared|||PCS outcome (baseline vs 6 months)||||.576
72523380|NCT02033850|144576797|SUPERIORITY|||||||0.191|||||||Chi-squared|||PCS outcome (6 vs 12 months)||||.191
72625101|NCT05318287|144779840|EQUIVALENCE|Whether change in linear slope from pretest through the 8-week follow-up is equivalent to zero (null hypothesis).|Slope|-0.02|STANDARD_ERROR_OF_MEAN|0.02||0.16|TWO_SIDED||||||t-test, 2 sided|||||||.160
72625102|NCT05318287|144779841|EQUIVALENCE|Whether change in linear slope from pretest through the 8-week follow-up is equivalent to zero (null hypothesis).|Slope|0.01|STANDARD_ERROR_OF_MEAN|0.01||0.167|TWO_SIDED||||||t-test, 2 sided|||||||.167
72625103|NCT05318287|144779842|EQUIVALENCE|Whether change in linear slope from pretest through the 8-week follow-up is equivalent to zero (null hypothesis).|Slope|0.02|STANDARD_ERROR_OF_MEAN|0.01||0.012|TWO_SIDED||||||t-test, 2 sided|||||||.012
72523381|NCT02033850|144576797|SUPERIORITY|||||||0.79|||||||Chi-squared|||PCS outcome (baseline vs 12 months)||||.790
72523382|NCT02033850|144576798|SUPERIORITY|||||||0.936|||||||t-test, 2 sided|||Δs on MoCA (baseline vs 6 months)||||.936
72523383|NCT02033850|144576798|SUPERIORITY|||||||0.188|||||||t-test, 2 sided|||Δs on MoCA (6 vs 12 months)||||.188
72625104|NCT05318287|144779843|EQUIVALENCE|Whether change in linear slope from pretest through the 8-week follow-up is equivalent to zero (null hypothesis).|Slope|-0.01|STANDARD_ERROR_OF_MEAN|0.01||0.347|TWO_SIDED||||||t-test, 2 sided|||||||.347
72523384|NCT02033850|144576798|SUPERIORITY|||||||0.381|||||||t-test, 2 sided|||Δs on MoCA (baseline vs 12 months)||||.381
72523385|NCT02033850|144576798|SUPERIORITY|||||||0.458|||||||t-test, 2 sided|||Δs on MMSE (baseline vs 6 months)||||.458
72523386|NCT02033850|144576798|SUPERIORITY|||||||0.236|||||||t-test, 2 sided|||Δs on MMSE (6 vs 12 months)||||.236
72523387|NCT02033850|144576798|SUPERIORITY|||||||0.601|||||||t-test, 2 sided|||Δs on MMSE (baseline vs 12 months)||||.601
72523388|NCT02033850|144576798|SUPERIORITY|||||||0.839|||||||t-test, 2 sided|||Δs on RAVL immediate (baseline vs 6 months)||||.839
72523389|NCT02033850|144576798|SUPERIORITY|||||||0.021|||||||t-test, 2 sided|||Δs on RAVL immediate (6 vs 12 months)||||.021
72523390|NCT02033850|144576798|SUPERIORITY|||||||0.032|||||||t-test, 2 sided|||Δs on RAVL immediate (baseline vs 12 months)||||.032
72523391|NCT02033850|144576798|SUPERIORITY|||||||0.858|||||||t-test, 2 sided|||Δs on RAVL recall (baseline vs 6 months)||||.858
72523392|NCT02033850|144576798|SUPERIORITY|||||||0.212|||||||t-test, 2 sided|||Δs on RAVL recall (6 vs 12 months)||||.212
72523393|NCT02033850|144576798|SUPERIORITY|||||||0.268|||||||t-test, 2 sided|||Δs on RAVL recall (baseline vs 12 months)||||.268
72523394|NCT02033850|144576798|SUPERIORITY|||||||0.184|||||||t-test, 2 sided|||Δs on ROCF recall (baseline vs 6 months)||||.184
72523395|NCT02033850|144576798|SUPERIORITY|||||||0.358|||||||t-test, 2 sided|||Δs on ROCF recall (6 vs 12 months)||||.358
72625105|NCT05318287|144779844|EQUIVALENCE|Whether change in linear slope from pretest through the 8-week follow-up is equivalent to zero (null hypothesis).|Slope|0.05|STANDARD_ERROR_OF_MEAN|0.02||0.007|TWO_SIDED||||||t-test, 2 sided|||||||.007
72625106|NCT05318287|144779845|EQUIVALENCE|Whether change in linear slope from pretest through the 8-week follow-up is equivalent to zero (null hypothesis).|Slope|-0.08|STANDARD_ERROR_OF_MEAN|0.02||0.001|TWO_SIDED||||||t-test, 2 sided|||||||.001
72625107|NCT05318287|144779846|EQUIVALENCE|Whether change in linear slope from pretest through the 8-week follow-up is equivalent to zero (null hypothesis).|Slope|-0.02|STANDARD_ERROR_OF_MEAN|0.02||0.403|TWO_SIDED||||||t-test, 2 sided|||||||.403
72523396|NCT02033850|144576798|SUPERIORITY|||||||0.768|||||||t-test, 2 sided|||Δs on ROCF recall (baseline vs 12 months)||||.768
72523397|NCT02033850|144576798|SUPERIORITY|||||||0.164|||||||t-test, 2 sided|||Δs on short story (baseline vs 6 months)||||.164
72523398|NCT02033850|144576798|SUPERIORITY|||||||0.42|||||||t-test, 2 sided|||Δs on short story (6 vs 12 months)||||.420
72523399|NCT02033850|144576798|SUPERIORITY|||||||0.527|||||||t-test, 2 sided|||Δs on short story (baseline vs 12 months)||||.527
72625108|NCT05318287|144779847|EQUIVALENCE|Whether change in linear slope from pretest through the 8-week follow-up is equivalent to zero (null hypothesis).|Slope|-0.02|STANDARD_ERROR_OF_MEAN|0.01||0.194|TWO_SIDED||||||t-test, 2 sided|||||||.194
72523400|NCT02033850|144576798|SUPERIORITY|||||||0.762|||||||t-test, 2 sided|||Δs on visual search (baseline vs 6 months)||||.762
72523401|NCT02033850|144576798|SUPERIORITY|||||||0.405|||||||t-test, 2 sided|||Δs on visual search (6 vs 12 months)||||.405
72523402|NCT02033850|144576798|SUPERIORITY|||||||0.674|||||||t-test, 2 sided|||Δs on visual search (baseline vs 12 months)||||.674
72523403|NCT02033850|144576798|SUPERIORITY|||||||0.328|||||||t-test, 2 sided|||Δs on SDMT (baseline vs 6 months)||||.328
72523404|NCT02033850|144576798|SUPERIORITY|||||||0.198|||||||t-test, 2 sided|||Δs on SDMT (6 vs 12 months)||||.198
72523405|NCT02033850|144576798|SUPERIORITY|||||||0.639|||||||t-test, 2 sided|||Δs on SDMT (baseline vs 12 months)||||.639
72523406|NCT02033850|144576798|SUPERIORITY|||||||0.098|||||||t-test, 2 sided|||Δs on ROCF copy (baseline vs 6 months)||||.098
72523407|NCT02033850|144576798|SUPERIORITY|||||||0.235|||||||t-test, 2 sided|||Δs on ROCF copy (6 vs 12 months)||||.235
72523408|NCT02033850|144576798|SUPERIORITY|||||||0.789|||||||t-test, 2 sided|||Δs on ROCF copy (baseline vs 12 months)||||.789
72523409|NCT02033850|144576799|SUPERIORITY|||||||0.743|||||||t-test, 2 sided|||Δs on Stroop test (baseline vs 6 months)||||.743
72523410|NCT02033850|144576799|SUPERIORITY|||||||0.428|||||||t-test, 2 sided|||Δs on Stroop test (6 vs 12 months)||||.428
72523411|NCT02033850|144576799|SUPERIORITY|||||||0.294|||||||t-test, 2 sided|||Δs on Stroop test (baseline vs 12 months)||||.294
72523412|NCT02033850|144576799|SUPERIORITY|||||||0.157|||||||t-test, 2 sided|||Δs on TMT-A (baseline vs 6 months)||||.157
72523413|NCT02033850|144576799|SUPERIORITY|||||||0.094|||||||t-test, 2 sided|||Δs on TMT-A (6 vs 12 months)||||.094
72523414|NCT02033850|144576799|SUPERIORITY|||||||0.476|||||||t-test, 2 sided|||Δs on TMT-A (baseline vs 12 months)||||.476
72523415|NCT02033850|144576799|SUPERIORITY|||||||0.142|||||||t-test, 2 sided|||Δs on TMT-B (baseline vs 6 months)||||.142
72523416|NCT02033850|144576799|SUPERIORITY|||||||0.651|||||||t-test, 2 sided|||Δs on TMT-B (6 vs 12 months)||||.651
72523417|NCT02033850|144576799|SUPERIORITY|||||||0.534|||||||t-test, 2 sided|||Δs on TMT-B (baseline vs 12 months)||||.534
72523418|NCT02033850|144576800|SUPERIORITY|||||||0.882|||||||t-test, 2 sided|||Δs on phonemic fluency (baseline vs 6 months)||||.882
72523419|NCT02033850|144576800|SUPERIORITY|||||||0.835|||||||t-test, 2 sided|||Δs on phonemic fluency (6 vs 12 months)||||.835
72523420|NCT02033850|144576800|SUPERIORITY|||||||0.951|||||||t-test, 2 sided|||Δs on phonemic fluency (baseline vs 12 months)||||.951
72523421|NCT02033850|144576800|SUPERIORITY|||||||0.392|||||||t-test, 2 sided|||Δs on semantic fluency (baseline vs 6 months)||||.392
72523422|NCT02033850|144576800|SUPERIORITY|||||||0.973|||||||t-test, 2 sided|||Δs on semantic fluency (6 vs 12 months)||||.973
72523423|NCT02033850|144576800|SUPERIORITY|||||||0.486|||||||t-test, 2 sided|||Δs on semantic fluency (baseline vs 12 months)||||.486
72625109|NCT00391716|144779861|SUPERIORITY_OR_OTHER||||||<|0.04|TWO_SIDED|||||The numerator is the number of subjects completely abstinent and the denominator is the number of subjects randomized, within each treatment group.|Mantel Haenszel|Extended Mantel-Haenszel Chi-square test for linear-by-linear association.||The extended Mantel-Haenszel Chi-square test for linear trend assesses the relationship between ROW and COLUMN of a single contingency table, where both row (dose: 0mg, 900mg, 1800mg) and column (response (0= non-abstinent, 1=abstinent), and at least 1 variable has more than 2 levels. It specifically tests linear dose-response without need for multiple comparisons.||||<0.04
72523424|NCT02033850|144576801|SUPERIORITY|||||||0.92|||||||Chi-squared|||MoCA variations (baseline vs 6 months)||||.920
72523425|NCT02033850|144576801|SUPERIORITY|||||||0.17|||||||Chi-squared|||MoCA variations (6 vs 12 months)||||.170
72523426|NCT02033850|144576801|SUPERIORITY|||||||0.716|||||||Chi-squared|||MoCA variations (baseline vs 12 months)||||.716
72523427|NCT02033850|144576801|SUPERIORITY|||||||0.973|||||||Chi-squared|||MMSE variations (baseline vs 6 months)||||.973
72523428|NCT02033850|144576801|SUPERIORITY|||||||0.973|||||||Chi-squared|||MMSE variations (6 vs 12 months)||||.973
72523429|NCT02033850|144576801|SUPERIORITY|||||||0.3|||||||Chi-squared|||MMSE variations (baseline vs 12 months)||||.300
72523430|NCT02033850|144576801|SUPERIORITY|||||||0.068|||||||Chi-squared|||RAVL immed. variations (baseline vs 6 months)||||.068
72523431|NCT02033850|144576801|SUPERIORITY|||||||0.089|||||||Chi-squared|||RAVL immed. variations (6 vs 12 months)||||.089
72523432|NCT02033850|144576801|SUPERIORITY|||||||0.241|||||||Chi-squared|||RAVL immed. variations (baseline vs 12 months)||||.241
72523433|NCT02033850|144576801|SUPERIORITY|||||||0.089|||||||Chi-squared|||RAVL recall variations (baseline vs 6 months)||||.089
72523434|NCT02033850|144576801|SUPERIORITY|||||||0.17|||||||Chi-squared|||RAVL recall variations (6 vs 12 months)||||.170
72523435|NCT02033850|144576801|SUPERIORITY|||||||0.413|||||||Chi-squared|||RAVL recall variations (baseline vs 12 months)||||.413
72523436|NCT02033850|144576801|SUPERIORITY|||||||0.777|||||||Chi-squared|||ROCF recall variations (baseline vs 6 months)||||.777
72523437|NCT02033850|144576801|SUPERIORITY|||||||0.134|||||||Chi-squared|||ROCF recall variations (6 vs 12 months)||||.134
72523438|NCT02033850|144576801|SUPERIORITY|||||||0.498|||||||Chi-squared|||ROCF recall variations (baseline vs 12 months)||||.498
72523439|NCT02033850|144576801|SUPERIORITY|||||||0.942|||||||Chi-squared|||Short story variations (baseline vs 6 months)||||.942
72523440|NCT02033850|144576801|SUPERIORITY|||||||0.578|||||||Chi-squared|||Short story variations (6 vs 12 months)||||.578
72523441|NCT02033850|144576801|SUPERIORITY|||||||0.413|||||||Chi-squared|||Short story variations (baseline vs 12 months)||||.413
72523442|NCT02033850|144576801|SUPERIORITY|||||||1|||||||Chi-squared|||Visual search variations (baseline vs 6 months)||||1
72523443|NCT02033850|144576801|SUPERIORITY|||||||0.038|||||||Chi-squared|||Visual search variations (6 vs 12 months)||||.038
72523444|NCT02033850|144576801|SUPERIORITY|||||||0.658|||||||Chi-squared|||Visual search variations (baseline vs 12 months)||||.658
72523445|NCT02033850|144576801|SUPERIORITY|||||||0.522|||||||Chi-squared|||SDMT variations (baseline vs 6 months)||||.522
72523446|NCT02033850|144576801|SUPERIORITY|||||||0.674|||||||Chi-squared|||SDMT variations (6 vs 12 months)||||.674
72523447|NCT02033850|144576801|SUPERIORITY|||||||0.17|||||||Chi-squared|||SDMT variations (baseline vs 12 months)||||.170
72523448|NCT02033850|144576801|SUPERIORITY|||||||0.961|||||||Chi-squared|||Stroop test variations (baseline vs 6 months)||||.961
72523449|NCT02033850|144576801|SUPERIORITY|||||||0.413|||||||Chi-squared|||Stroop test variations (6 vs 12 months)||||.413
72523450|NCT02033850|144576801|SUPERIORITY|||||||0.477|||||||Chi-squared|||Stroop test variations (baseline vs 12 months)||||.477
72523451|NCT02033850|144576801|SUPERIORITY|||||||0.42|||||||Chi-squared|||TMT-A variations (baseline vs 6 months)||||.420
72523452|NCT02033850|144576801|SUPERIORITY|||||||0.241|||||||Chi-squared|||TMT-A variations (6 vs 12 months)||||.241
72523453|NCT02033850|144576801|SUPERIORITY|||||||0.295|||||||Chi-squared|||TMT-A variations (baseline vs 12 months)||||.295
72523454|NCT02033850|144576801|SUPERIORITY|||||||0.453|||||||Chi-squared|||TMT-B variations (baseline vs 6 months)||||.453
72523455|NCT02033850|144576801|SUPERIORITY|||||||0.952|||||||Chi-squared|||TMT-B variations (6 vs 12 months)||||.952
72523456|NCT02033850|144576801|SUPERIORITY|||||||0.881|||||||Chi-squared|||TMT-B variations (baseline vs 12 months)||||.881
72523457|NCT02033850|144576801|SUPERIORITY|||||||0.413|||||||Chi-squared|||Phonemic fluency variations (baseline vs 6 months)||||.413
72523458|NCT02033850|144576801|SUPERIORITY|||||||0.961|||||||Chi-squared|||Phonemic fluency variations (6 vs 12 months)||||.961
72523459|NCT02033850|144576801|SUPERIORITY|||||||0.951|||||||Chi-squared|||Phonemic fluency variation (baseline vs 12 months)||||.951
72523460|NCT02033850|144576801|SUPERIORITY|||||||0.951|||||||Chi-squared|||Semantic fluency variations (baseline vs 6 months)||||.951
72523461|NCT02033850|144576801|SUPERIORITY|||||||0.674|||||||Chi-squared|||Semantic fluency variations (6 vs 12 months)||||.674
72523462|NCT02033850|144576801|SUPERIORITY|||||||0.951|||||||Chi-squared|||Semantic fluency variation (baseline vs 12 months)||||.951
72523463|NCT02033850|144576801|SUPERIORITY|||||||1|||||||Chi-squared|||ROCF copy variations (baseline vs 6 months)||||1
72523464|NCT02033850|144576801|SUPERIORITY|||||||0.027|||||||Chi-squared|||ROCF copy variations (6 vs 12 months)||||.027
72523465|NCT02033850|144576801|SUPERIORITY|||||||0.169|||||||Chi-squared|||ROCF copy variations (baseline vs 12 months)||||.169
72523466|NCT02033850|144576802|SUPERIORITY|||||||0.478|||||||Chi-squared|||||||.478
72523467|NCT02033850|144576803|SUPERIORITY|||||||0.029||||||"Corrected for multiple comparisons using the 3D parameter settings with threshold-free cluster enhancement.~A priori threshold for statistical significance 0.05"|General linear model voxel-wise|||Z-transformed ReHo difference in vermis VIIIb||||0.029
72570697|NCT02504671|144670143|OTHER||Mean Difference (Net)|1.46||||0.39|TWO_SIDED|95.0|-1.88|4.8||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, PCS|||4.80|-1.88|0.390
72570698|NCT02504671|144670143|OTHER||Mean Difference (Net)|2.42||||0.154|TWO_SIDED|95.0|-0.91|5.75||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, PCS|||5.75|-0.91|0.154
72570699|NCT02504671|144670143|OTHER||Mean Difference (Net)|1.73||||0.302|TWO_SIDED|95.0|-1.56|5.02||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, PCS|||5.02|-1.56|0.302
72570700|NCT02504671|144670143|OTHER||Mean Difference (Net)|1.69||||0.521|TWO_SIDED|95.0|-3.5|6.88||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, PCS|||6.88|-3.50|0.521
72570701|NCT02504671|144670143|OTHER||Mean Difference (Net)|1.28||||0.606|TWO_SIDED|95.0|-3.63|6.2||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, PCS|||6.20|-3.63|0.606
72406377|NCT02942017|144321622|SUPERIORITY||LS Mean Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.18||0.6187|TWO_SIDED|95.0|-0.45|0.27|||MMRM|||Insomnia-Early, Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.27|-0.45|0.6187
72523468|NCT02033850|144576803|SUPERIORITY|||||||0.04||||||"Corrected for multiple comparisons using the 3D parameter settings with threshold-free cluster enhancement.~A priori threshold for statistical significance 0.05"|General linear model voxel-wise|||Z-transformed ReHo difference in right VIIb lobule||||0.04
72523469|NCT02033850|144576803|SUPERIORITY|||||||0.039||||||"Corrected for multiple comparisons using the 3D parameter settings with threshold-free cluster enhancement.~A priori threshold for statistical significance 0.05"|General linear model voxel-wise|||Z-transformed ReHo difference in left VIIb lobule||||0.039
72523470|NCT01810380|144576810|SUPERIORITY_OR_OTHER||Least square mean difference|-4.1|STANDARD_ERROR_OF_MEAN|2.1||0.056|TWO_SIDED|95.0|-8.2|0.1||For all efficacy analyses the primary comparison is the difference between brexpiprazole 2 to 4 mg/day and placebo at Week 6.|Mixed Models Analysis|Pooled site, visit, treatment as fixed effects, baseline score as continuous covariate, treatment-by-visit and baseline score-by-visit as interactions||The overall significance level was 0.05. The primary and the key secondary endpoints were tested hierarchically. Only if the primary endpoint was statistically significant would confirmatory testing continue with the key secondary endpoint.||0.1|-8.2|0.0560
72570702|NCT02504671|144670143|OTHER||Mean Difference (Net)|2.46||||0.32|TWO_SIDED|95.0|-2.41|7.32||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, PCS|||7.32|-2.41|0.320
72570703|NCT02504671|144670143|OTHER||Mean Difference (Net)|-0.5||||0.811|TWO_SIDED|95.0|-4.65|3.64||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, MCS|||3.64|-4.65|0.811
72523471|NCT01810380|144576810|SUPERIORITY_OR_OTHER||Least square mean difference|-8.0|STANDARD_ERROR_OF_MEAN|2.1||0.0002|TWO_SIDED|95.0|-12.2|-3.9|||Mixed Models Analysis|||||-3.9|-12.2|0.0002
72523472|NCT03209362|144576899|SUPERIORITY||Least Squares Mean Difference|-2.9||||0.5453|TWO_SIDED|95.0|-12.4|6.6|||ANCOVA|||||6.6|-12.4|0.5453
72523473|NCT03209362|144576900|SUPERIORITY||Least Squares Mean Difference|-3.5||||0.5386|TWO_SIDED|95.0|-14.9|7.8|||Longitudinal model|||Week 12||7.8|-14.9|0.5386
72523474|NCT03209362|144576900|SUPERIORITY||Least Squares Mean Difference|-3.3||||0.5873|TWO_SIDED|95.0|-15.2|8.6|||Longitudinal model|||Week 26||8.6|-15.2|0.5873
72523475|NCT03209362|144576901|SUPERIORITY||Least Squares Mean Difference|-2.9||||0.6347|TWO_SIDED|95.0|-15.0|9.2|||Longitudinal model|||Week 12||9.2|-15.0|0.6347
72523476|NCT03209362|144576901|SUPERIORITY||Least Squares Mean Difference|-1.8||||0.7806|TWO_SIDED|95.0|-14.3|10.8|||Longitudinal model|||Week 26||10.8|-14.3|0.7806
72523477|NCT03209362|144576902|SUPERIORITY||Least Squares Mean Difference|-0.9||||0.8819|TWO_SIDED|95.0|-13.2|11.4|||Longitudinal model|||Week 12||11.4|-13.2|0.8819
72523478|NCT03209362|144576902|SUPERIORITY||Least Squares Mean Difference|-5.6||||0.3796|TWO_SIDED|95.0|-18.3|7.1|||Longitudinal model|||Week 26||7.1|-18.3|0.3796
72523479|NCT03209362|144576903|SUPERIORITY||Least Squares Mean Difference|-3.0||||0.6217|TWO_SIDED|95.0|-14.9|9.0|||Longitudinal model|||Week 12||9.0|-14.9|0.6217
72570704|NCT02504671|144670143|OTHER||Mean Difference (Net)|0.45||||0.83|TWO_SIDED|95.0|-3.65|4.55||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, MCS|||4.55|-3.65|0.830
72570705|NCT02504671|144670143|OTHER||Mean Difference (Net)|-0.54||||0.795|TWO_SIDED|95.0|-4.61|3.54||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, MCS|||3.54|-4.61|0.795
72570706|NCT02504671|144670143|OTHER||Mean Difference (Net)|1.32||||0.548|TWO_SIDED|95.0|-3.0|5.64||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, MCS|||5.64|-3.00|0.548
72570707|NCT02504671|144670143|OTHER||Mean Difference (Net)|1.46||||0.505|TWO_SIDED|95.0|-2.85|5.77||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, MCS|||5.77|-2.85|0.505
72570708|NCT02504671|144670143|OTHER||Mean Difference (Net)|1.12||||0.605|TWO_SIDED|95.0|-3.15|5.39||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, MCS|||5.39|-3.15|0.605
72570709|NCT02504671|144670143|OTHER||Mean Difference (Net)|0.43||||0.895|TWO_SIDED|95.0|-6.03|6.9||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, MCS|||6.90|-6.03|0.895
72570710|NCT02504671|144670143|OTHER||Mean Difference (Net)|2.29||||0.461|TWO_SIDED|95.0|-3.84|8.42||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, MCS|||8.42|-3.84|0.461
72406378|NCT02942017|144321622|SUPERIORITY||LS Mean Difference|-0.39|STANDARD_ERROR_OF_MEAN|0.163||0.0187|TWO_SIDED|95.0|-0.72|-0.07|||MMRM|||Insomnia-Early, Hour 72 MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.07|-0.72|0.0187
72523480|NCT03209362|144576903|SUPERIORITY||Least Squares Mean Difference|-2.5||||0.6901|TWO_SIDED|95.0|-14.8|9.8|||Longitudinal model|||Week 26||9.8|-14.8|0.6901
72523481|NCT01627782|144576938|SUPERIORITY_OR_OTHER_LEGACY||Difference of Least Square Means|-16.0|||<|0.001|TWO_SIDED|70.0|-20.0|-12.01|||Mixed Effect Model Repeated Measure|||||-12.01|-20.00|< 0.001
72523482|NCT01627782|144576938|SUPERIORITY_OR_OTHER_LEGACY||Difference of Least Square Means|-16.4|||<|0.001|TWO_SIDED|70.0|-18.96|-13.84|||Mixed Effect Model Repeated Measure|||||-13.84|-18.96|< 0.001
72523483|NCT04315298|144576992|SUPERIORITY||LS Mean (log scale)|-1.25|STANDARD_ERROR_OF_MEAN|0.107|<|0.0001|TWO_SIDED|95.0|-1.456|-1.035||P-value is based on the ANCOVA model for differences between treatment groups in terms of \[ln(CRP at day 4 ) - ln(baseline CRP)\].|ANCOVA|||||-1.035|-1.456|<0.0001
72523484|NCT04315298|144576992|SUPERIORITY||LS Mean (log scale)|-1.3|STANDARD_ERROR_OF_MEAN|0.107|<|0.0001|TWO_SIDED|95.0|-1.511|-1.09||p-value is based on the ANCOVA model for differences between treatment groups in terms of \[ln(CRP at day 4 ) - ln(baseline CRP)\].|ANCOVA|||||-1.090|-1.511|<0.0001
72523485|NCT04315298|144576993|SUPERIORITY||Risk Difference (RD)|7.1||||0.3707|TWO_SIDED|95.0|-8.4|21.7||P-value based on stratified Cochran-Mantel-Haenszel test using the strata Use of Steroids at Baseline.|Cochran-Mantel-Haenszel|||||21.7|-8.4|0.3707
72523486|NCT04315298|144576993|SUPERIORITY||Risk Difference (RD)|7.5||||0.3261|TWO_SIDED|95.0|-7.4|21.3||P-value based on stratified Cochran-Mantel-Haenszel test using the strata Use of Steroids at Baseline.|Cochran-Mantel-Haenszel|||||21.3|-7.4|0.3261
72523487|NCT04315298|144576994|SUPERIORITY||Risk Difference (RD)|6.2||||0.7328|TWO_SIDED|95.0|-26.2|36.8|||Cochran-Mantel-Haenszel|P-value based on stratified Cochran-Mantel-Haenszel test using the strata Use of Steroids at Baseline||||36.8|-26.2|0.7328
72523488|NCT04315298|144576995|SUPERIORITY||Hazard Ratio (HR)|1.12||||0.5687|TWO_SIDED|95.0|0.76|1.66||P-value based on log-rank test stratified by disease severity (severe, critical) and use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||||1.66|0.76|0.5687
72523489|NCT04315298|144576995|SUPERIORITY||Hazard Ratio (HR)|1.09||||0.7014|TWO_SIDED|95.0|0.74|1.62||P-value based on log-rank test stratified by disease severity (severe, critical) and use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||||1.62|0.74|0.7014
72570711|NCT02504671|144670143|OTHER||Mean Difference (Net)|-1.05||||0.732|TWO_SIDED|95.0|-7.1|4.99||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, MCS|||4.99|-7.10|0.732
72570712|NCT02504671|144670143|OTHER||Mean Difference (Net)|-0.11||||0.941|TWO_SIDED|95.0|-3.11|2.88||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, Bodily Pain|||2.88|-3.11|0.941
72523490|NCT04315298|144576996|SUPERIORITY||Hazard Ratio (HR)|1.18||||0.3622|TWO_SIDED|95.0|0.83|1.7||P-value based on log-rank test stratified by disease severity (severe, critical) and use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||||1.70|0.83|0.3622
72523491|NCT04315298|144576996|SUPERIORITY||Hazard Ratio (HR)|1.13||||0.5802|TWO_SIDED|95.0|0.79|1.63||P-value based on log-rank test stratified by disease severity (severe, critical) and use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||||1.63|0.79|0.5802
72523492|NCT04315298|144576997|SUPERIORITY||Hazard Ratio (HR)|1.29||||0.234|TWO_SIDED|95.0|0.83|2.02||P-value based on log-rank test stratified by disease severity (severe, critical and MSOD) and use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||||2.02|0.83|0.2340
72523493|NCT04315298|144576997|SUPERIORITY||Hazard Ratio (HR)|1.15||||0.6949|TWO_SIDED|95.0|0.74|1.79||P-value based on log-rank test stratified by disease severity (severe, critical and MSOD) and use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||||1.79|0.74|0.6949
72523494|NCT04315298|144576998|SUPERIORITY||Hazard Ratio (HR)|1.27||||0.3151|TWO_SIDED|95.0|0.66|2.43||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||Disease Severity: Severe||2.43|0.66|0.3151
72523495|NCT04315298|144576998|SUPERIORITY||Hazard Ratio (HR)|0.74||||0.1884|TWO_SIDED|95.0|0.39|1.41||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||Disease Severity: Severe||1.41|0.39|0.1884
72523496|NCT04315298|144576998|SUPERIORITY||Hazard Ratio (HR)|1.61||||0.4356|TWO_SIDED|95.0|0.76|3.4||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||Disease Severity: Critical||3.40|0.76|0.4356
72523497|NCT04315298|144576998|SUPERIORITY||Hazard Ratio (HR)|2.1||||0.0371|TWO_SIDED|95.0|1.01|4.4||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||Disease Severity: Critical||4.40|1.01|0.0371
72523498|NCT04315298|144576998|SUPERIORITY||Hazard Ratio (HR)|0.98||||0.8923|TWO_SIDED|95.0|0.32|3.05||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||Disease Severity: MSOD||3.05|0.32|0.8923
72523499|NCT04315298|144576998|SUPERIORITY||Hazard Ratio (HR)|0.83||||0.694|TWO_SIDED|95.0|0.25|2.71||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||Disease Severity: MSOD||2.71|0.25|0.6940
72523500|NCT04315298|144576999|SUPERIORITY||Hazard Ratio (HR)|2.14||||0.0832|TWO_SIDED|95.0|0.81|5.65||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||Disease Severity: Severe Baseline IL-6 \< 87.04 pg/mL (median)||5.65|0.81|0.0832
72570713|NCT02504671|144670143|OTHER||Mean Difference (Net)|3.73||||0.013|TWO_SIDED|95.0|0.78|6.67||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, Bodily Pain|||6.67|0.78|0.013
72406379|NCT02942017|144321622|SUPERIORITY||LS Mean Difference|-0.26|STANDARD_ERROR_OF_MEAN|0.18||0.1531|TWO_SIDED|95.0|-0.62|0.1|||MMRM|||Insomnia-Early, Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.10|-0.62|0.1531
72406380|NCT02942017|144321622|SUPERIORITY||LS Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.197||0.3341|TWO_SIDED|95.0|-0.58|0.2|||MMRM|||Insomnia-Early, Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.20|-0.58|0.3341
72406381|NCT02942017|144321622|SUPERIORITY||LS Mean Difference|0.03|STANDARD_ERROR_OF_MEAN|0.216||0.8969|TWO_SIDED|95.0|-0.4|0.46|||MMRM|||Insomnia-Early, Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.46|-0.40|0.8969
72406382|NCT02942017|144321622|SUPERIORITY||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.174||0.5862|TWO_SIDED|95.0|-0.25|0.44|||MMRM|||Insomnia-Early, Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.44|-0.25|0.5862
72406383|NCT02942017|144321622|SUPERIORITY||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.117||0.3776|TWO_SIDED|95.0|-0.13|0.34|||MMRM|||Insomnia-Middle, Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.34|-0.13|0.3776
72406384|NCT02942017|144321622|SUPERIORITY||LS Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.121||0.9029|TWO_SIDED|95.0|-0.26|0.23|||MMRM|||Insomnia-Middle, Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.23|-0.26|0.9029
72406385|NCT02942017|144321622|SUPERIORITY||LS Mean Difference|0.06|STANDARD_ERROR_OF_MEAN|0.121||0.6173|TWO_SIDED|95.0|-0.18|0.3|||MMRM|||Insomnia-Middle, Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.30|-0.18|0.6173
72406386|NCT02942017|144321622|SUPERIORITY||LS Mean Difference|0.15|STANDARD_ERROR_OF_MEAN|0.124||0.2433|TWO_SIDED|95.0|-0.1|0.39|||MMRM|||Insomnia-Middle, Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.39|-0.10|0.2433
72406387|NCT02942017|144321622|SUPERIORITY||LS Mean Difference|-0.32|STANDARD_ERROR_OF_MEAN|0.139||0.0234|TWO_SIDED|95.0|-0.59|-0.04|||MMRM|||Insomnia-Middle, Hour 24 MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.04|-0.59|0.0234
72523501|NCT04315298|144576999|SUPERIORITY||Hazard Ratio (HR)|1.93||||0.1369|TWO_SIDED|95.0|0.77|4.8||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||Disease Severity: Severe Baseline IL-6 \< 87.04 pg/mL (median)||4.80|0.77|0.1369
72523502|NCT04315298|144576999|SUPERIORITY||Hazard Ratio (HR)|0.74||||0.9636|TWO_SIDED|95.0|0.28|1.95||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||Disease Severity: Severe Baseline IL-6 \>= 87.04 pg/mL (median)||1.95|0.28|0.9636
72523503|NCT04315298|144576999|SUPERIORITY||Hazard Ratio (HR)|0.24||||0.0038|TWO_SIDED|95.0|0.08|0.74||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||Disease Severity: Severe Baseline IL-6 \>= 87.04 pg/mL (median)||0.74|0.08|0.0038
72523504|NCT04315298|144576999|SUPERIORITY||Hazard Ratio (HR)|1.21||||0.738|TWO_SIDED|95.0|0.47|3.13||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||Disease Severity: Critical Baseline IL-6 \< 166.68pg/mL (Median)||3.13|0.47|0.7380
72523505|NCT04315298|144576999|SUPERIORITY||Hazard Ratio (HR)|1.21||||0.7342|TWO_SIDED|95.0|0.48|3.05||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||Disease Severity: Critical Baseline IL-6 \<166.68pg/mL (Median)||3.05|0.48|0.7342
72523506|NCT04315298|144576999|SUPERIORITY||Hazard Ratio (HR)|3.58||||0.1934|TWO_SIDED|95.0|0.79|16.17||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||Disease Severity: Critical Baseline IL-6 \>= 166.68pg/mL (Median)||16.17|0.79|0.1934
72523507|NCT04315298|144576999|SUPERIORITY||Hazard Ratio (HR)|5.33||||0.0159|TWO_SIDED|95.0|1.19|23.94||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||Disease Severity: Critical Baseline IL-6 \>= 166.68pg/mL (Median)||23.94|1.19|0.0159
72523508|NCT04315298|144576999|SUPERIORITY||Hazard Ratio (HR)|1.05||||0.6281|TWO_SIDED|95.0|0.13|8.75||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||Disease Severity: MSOD Baseline IL-6 \<254.95 pg/mL (Median)||8.75|0.13|0.6281
72523509|NCT04315298|144576999|SUPERIORITY||Hazard Ratio (HR)|0.62||||0.4971|TWO_SIDED|95.0|0.06|6.13||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||Disease Severity: MSOD Baseline IL-6 \<254.95 pg/mL (Median)||6.13|0.06|0.4971
72523510|NCT04315298|144576999|SUPERIORITY||Hazard Ratio (HR)|0.3||||0.299|TWO_SIDED|95.0|0.03|2.86||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||Disease Severity: MSOD Baseline IL-6 \>= 254.95 pg/mL (Median)||2.86|0.03|0.2990
72523511|NCT04315298|144576999|SUPERIORITY||Hazard Ratio (HR)|0.99||||0.936|TWO_SIDED|95.0|0.22|4.41||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||Disease Severity: MSOD Baseline IL-6 \>= 254.95 pg/mL (Median)||4.41|0.22|0.9360
72523512|NCT04315298|144577000|SUPERIORITY||Hazard Ratio (HR)|0.87||||0.9032|TWO_SIDED|95.0|0.52|1.47||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||Disease Severity: Severe||1.47|0.52|0.9032
72523513|NCT04315298|144577000|SUPERIORITY||Hazard Ratio (HR)|0.5||||0.0052|TWO_SIDED|95.0|0.29|0.88||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||Disease Severity: Severe||0.88|0.29|0.0052
72523514|NCT04315298|144577000|SUPERIORITY||Hazard Ratio (HR)|0.76||||0.1168|TWO_SIDED|95.0|0.48|1.21||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||Disease Severity: Critical||1.21|0.48|0.1168
72523515|NCT04315298|144577000|SUPERIORITY||Hazard Ratio (HR)|1.09||||0.3753|TWO_SIDED|95.0|0.69|1.72||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||Disease Severity: Critical||1.72|0.69|0.3753
72523516|NCT04315298|144577000|SUPERIORITY||Hazard Ratio (HR)|0.81||||0.4956|TWO_SIDED|95.0|0.4|1.66||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||Disease Severity: MSOD||1.66|0.40|0.4956
72523517|NCT04315298|144577000|SUPERIORITY||Cox Proportional Hazard|1.01||||0.8439|TWO_SIDED|95.0|0.5|2.02||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||Disease Severity: MSOD||2.02|0.50|0.8439
72523518|NCT04315298|144577001|SUPERIORITY||Hazard Ratio (HR)|1.21||||0.389|TWO_SIDED|95.0|0.52|2.79||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||Disease Severity: Severe Baseline IL-6 \< 67.11 pg/mL (median)||2.79|0.52|0.3890
72523519|NCT04315298|144577001|SUPERIORITY||Hazard Ratio (HR)|0.65||||0.7838||95.0|0.3|1.41||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||Disease Severity: Severe Baseline IL-6 \>= 67.11pg/mL (median)||1.41|0.30|0.7838
72523520|NCT04315298|144577001|SUPERIORITY||Hazard Ratio (HR)|0.68||||0.237|TWO_SIDED|95.0|0.28|1.65||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||Disease Severity: Severe Baseline IL-6 \< 67.11 pg/mL (median)||1.65|0.28|0.2370
72523521|NCT04315298|144577001|SUPERIORITY||Hazard Ratio (HR)|0.25||||0.0004||95.0|0.1|0.59||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||Disease Severity: Severe Baseline IL-6 \>= 67.11pg/mL (median)||0.59|0.10|0.0004
72523522|NCT04315298|144577001|SUPERIORITY||Hazard Ratio (HR)|0.7||||0.174|TWO_SIDED|95.0|0.37|1.32||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||Disease Severity: Critical Baseline IL-6 \< 131.90 pg/mL (median)||1.32|0.37|0.1740
72523523|NCT04315298|144577001|SUPERIORITY||Hazard Ratio (HR)|0.8||||0.3664|TWO_SIDED|95.0|0.38|1.66||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||Disease Severity: Critical Baseline IL-6 \>= 131.90 pg/mL (median)||1.66|0.38|0.3664
72523524|NCT04315298|144577001|SUPERIORITY||Hazard Ratio (HR)|1.0||||0.7318|TWO_SIDED|95.0|0.53|1.87||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||Disease Severity: Critical Baseline IL-6 \< 131.90 pg/mL (median)||1.87|0.53|0.7318
72523525|NCT04315298|144577001|SUPERIORITY||Hazard Ratio (HR)|1.18||||0.4155|TWO_SIDED|95.0|0.59|2.37||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||Disease Severity: Critical Baseline IL-6 \>= 131.90 pg/mL (median)||2.37|0.59|0.4155
72523526|NCT04315298|144577001|SUPERIORITY||Hazard Ratio (HR)|0.75||||0.6262|TWO_SIDED|95.0|0.23|2.45||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||Disease Severity: MSOD Baseline IL-6 \< 254.95 pg/mL (median)||2.45|0.23|0.6262
72523527|NCT04315298|144577001|SUPERIORITY||Hazard Ratio (HR)|0.7||||0.553||95.0|0.21|2.3||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||Disease Severity: MSOD Baseline IL-6 \>= 254.95 pg/mL (median)||2.30|0.21|0.5530
72523528|NCT04315298|144577001|SUPERIORITY||Hazard Ratio (HR)|0.85||||0.8775|TWO_SIDED|95.0|0.25|2.85||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||Disease Severity: MSOD Baseline IL-6 \< 254.95 pg/mL (median)||2.85|0.25|0.8775
72523529|NCT04315298|144577001|SUPERIORITY||Hazard Ratio (HR)|1.1||||0.7485|TWO_SIDED|95.0|0.41|2.99||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||Disease Severity: MSOD Baseline IL-6 \>= 254.95 pg/mL (median)||2.99|0.41|0.7485
72523530|NCT04315298|144577002|SUPERIORITY||Hazard Ratio (HR)|1.06||||0.4556|TWO_SIDED|95.0|0.63|1.79||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||Disease Severity: Severe||1.79|0.63|0.4556
72523531|NCT04315298|144577002|SUPERIORITY||Hazard Ratio (HR)|0.6||||0.0248|TWO_SIDED|95.0|0.35|1.04||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||Disease Severity: Severe||1.04|0.35|0.0248
72523532|NCT04315298|144577002|SUPERIORITY||Hazard Ratio (HR)|1.02||||0.6842|TWO_SIDED|95.0|0.62|1.67||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||Disease Severity: Critical||1.67|0.62|0.6842
72523533|NCT04315298|144577002|SUPERIORITY||Hazard Ratio (HR)|1.43||||0.0671|TWO_SIDED|95.0|0.89|2.32||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||Disease Severity: Critical||2.32|0.89|0.0671
72523534|NCT04315298|144577002|SUPERIORITY||Hazard Ratio (HR)|0.85||||0.6146|TWO_SIDED|95.0|0.41|1.74||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||Disease Severity: MSOD||1.74|0.41|0.6146
72523535|NCT04315298|144577002|SUPERIORITY||Hazard Ratio (HR)|0.98||||0.973|TWO_SIDED|95.0|0.48|1.99||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||Disease Severity: MSOD||1.99|0.48|0.9730
72523536|NCT04315298|144577004|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.6987|TWO_SIDED|95.0|0.59|1.59||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||Disease Severity: Severe||1.59|0.59|0.6987
72523537|NCT04315298|144577004|SUPERIORITY||Hazard Ratio (HR)|0.65||||0.0453|TWO_SIDED|95.0|0.39|1.09||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||Disease Severity: Severe||1.09|0.39|0.0453
72523538|NCT04315298|144577004|SUPERIORITY||Hazard Ratio (HR)|1.23||||0.9734|TWO_SIDED|95.0|0.73|2.09||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||Disease Severity: Critical||2.09|0.73|0.9734
72570714|NCT02504671|144670143|OTHER||Mean Difference (Net)|2.92||||0.051|TWO_SIDED|95.0|-0.01|5.84||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, Bodily Pain|||5.84|-0.01|0.051
72570715|NCT02504671|144670143|OTHER||Mean Difference (Net)|1.53||||0.403|TWO_SIDED|95.0|-2.07|5.12||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, Bodily Pain|||5.12|-2.07|0.403
72406388|NCT02942017|144321622|SUPERIORITY||LS Mean Difference|-0.27|STANDARD_ERROR_OF_MEAN|0.139||0.054|TWO_SIDED|95.0|-0.55|0.0|||MMRM|||Insomnia-Middle, Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.00|-0.55|0.0540
72523539|NCT04315298|144577004|SUPERIORITY||Hazard Ratio (HR)|1.91||||0.004|TWO_SIDED|95.0|1.14|3.2||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No)|Log Rank|||Disease Severity: Critical||3.20|1.14|0.0040
72523540|NCT04315298|144577004|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.9551|TWO_SIDED|95.0|0.43|2.17||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||Disease Severity: MSOD||2.17|0.43|0.9551
72523541|NCT04315298|144577004|SUPERIORITY||Hazard Ratio (HR)|0.94||||0.8722|TWO_SIDED|95.0|0.42|2.1||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||Disease Severity: MSOD||2.10|0.42|0.8722
72523542|NCT04315298|144577007|SUPERIORITY|||||||1|||||||Chi-squared|||Disease Severity: Severe||||1.0000
72523543|NCT04315298|144577007|SUPERIORITY|||||||0.0353|||||||Chi-squared|||Disease Severity: Severe||||0.0353
72523544|NCT04315298|144577007|SUPERIORITY|||||||0.3187|||||||Chi-squared|||Disease Severity: Critical||||0.3187
72523545|NCT04315298|144577007|SUPERIORITY|||||||0.0261|||||||Chi-squared|||Disease Severity: Critical||||0.0261
72523546|NCT04315298|144577007|SUPERIORITY|||||||0.9117|||||||Chi-squared|||Disease Severity: MSOD||||0.9117
72523547|NCT04315298|144577007|SUPERIORITY|||||||0.7584|||||||Chi-squared|||Disease Severity: MSOD||||0.7584
72523548|NCT04315298|144577011|SUPERIORITY||Hazard Ratio (HR)|0.32||||0.0385|TWO_SIDED|95.0|0.11|0.94||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||Disease Severity: Severe||0.94|0.11|0.0385
72523549|NCT04315298|144577011|SUPERIORITY||Hazard Ratio (HR)|0.38||||0.0782|TWO_SIDED|95.0|0.14|1.05||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||Disease Severity: Severe||1.05|0.14|0.0782
72523550|NCT04315298|144577011|SUPERIORITY||Hazard Ratio (HR)|1.22||||0.2436|TWO_SIDED|95.0|0.7|2.14||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||Disease Severity: Critical||2.14|0.70|0.2436
72523551|NCT04315298|144577011|SUPERIORITY||Hazard Ratio (HR)|0.83||||0.3223|TWO_SIDED|95.0|0.46|1.51||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||Disease Severity: Critical||1.51|0.46|0.3223
72523552|NCT04315298|144577011|SUPERIORITY||Hazard Ratio (HR)|0.74||||0.467|TWO_SIDED|95.0|0.36|1.52||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||Disease Severity: MSOD||1.52|0.36|0.4670
72523553|NCT04315298|144577011|SUPERIORITY||Hazard Ratio (HR)|0.71||||0.3728|TWO_SIDED|95.0|0.35|1.47||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||Disease Severity: MSOD||1.47|0.35|0.3728
72523554|NCT04315298|144577017|SUPERIORITY||Risk Difference (RD)|2.7||||0.5851|TWO_SIDED|95.0|-7.0|12.4||P-value based on stratified Cochran-Mantel-Haenszel test using the strata Use of Steroids at Baseline.|Cochran-Mantel-Haenszel|||||12.4|-7.0|0.5851
72523555|NCT04315298|144577017|SUPERIORITY||Risk Difference (RD)|-2.6||||0.5767|TWO_SIDED|95.0|-11.7|6.5||P-value based on stratified Cochran-Mantel-Haenszel test using the strata Use of Steroids at Baseline.|Cochran-Mantel-Haenszel|||||6.5|-11.7|0.5767
72523556|NCT04315298|144577018|SUPERIORITY||Risk Difference (RD)|5.2||||0.4777|TWO_SIDED|95.0|-9.4|18.6||P-value based on stratified Cochran-Mantel-Haenszel test using the strata Use of Steroids at Baseline.|Cochran-Mantel-Haenszel|||||18.6|-9.4|0.4777
72570716|NCT02504671|144670143|OTHER||Mean Difference (Net)|2.82||||0.122|TWO_SIDED|95.0|-0.76|6.4||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, Bodily Pain|||6.40|-0.76|0.122
72570717|NCT02504671|144670143|OTHER||Mean Difference (Net)|2.08||||0.247|TWO_SIDED|95.0|-1.45|5.62||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, Bodily Pain|||5.62|-1.45|0.247
72625110|NCT00391716|144779861|SUPERIORITY_OR_OTHER||||||<|0.02|TWO_SIDED|||||linear dose effects for rates of abstinence were assessed using the extended Mantel-Haenszel chi-square test for linear association.|Mantel Haenszel|The numerator is the number of subjects completely abstinent and the denominator is the number of subjects randomized, within each treatment group.||The extended Mantel-Haenszel Chi-square test for linear trend assesses the relationship between ROW and COLUMN of a single contingency table, where both row (dose: 0mg, 900mg, 1800mg) and column (response (0= heavy drinking, 1=no heavy drinking), and at least 1 variable has more than 2 levels. It specifically tests linear dose-response without need for multiple comparisons.||||<0.02
72523557|NCT04315298|144577018|SUPERIORITY||Risk Difference (RD)|5.7||||0.4202|TWO_SIDED|95.0|-8.4|18.2||P-value based on stratified Cochran-Mantel-Haenszel test using the strata Use of Steroids at Baseline.|Cochran-Mantel-Haenszel|||||18.2|-8.4|0.4202
72523558|NCT04315298|144577019|SUPERIORITY||Risk Difference (RD)|0.2||||0.9696|TWO_SIDED|95.0|-9.5|9.9||P-value based on stratified Cochran-Mantel-Haenszel test using the strata Use of Steroids at Baseline.|Cochran-Mantel-Haenszel|||||9.9|-9.5|0.9696
72523559|NCT04315298|144577019|SUPERIORITY||Risk Difference (RD)|-4.7||||0.3152|TWO_SIDED|95.0|-13.8|4.4||P-value based on stratified Cochran-Mantel-Haenszel test using the strata Use of Steroids at Baseline.|Cochran-Mantel-Haenszel|||||4.4|-13.8|0.3152
72523560|NCT04315298|144577020|SUPERIORITY||Risk Difference (RD)|-7.7||||0.3217|TWO_SIDED|95.0|-22.8|7.2||P-value based on stratified Cochran-Mantel-Haenszel test using the strata Use of Steroids at Baseline.|Cochran-Mantel-Haenszel|||Through Day 29||7.2|-22.8|0.3217
72523561|NCT04315298|144577020|SUPERIORITY||Risk Difference (RD)|-5.5||||0.463|TWO_SIDED|95.0|-20.2|8.7||P-value based on stratified Cochran-Mantel-Haenszel test using the strata Use of Steroids at Baseline.|Cochran-Mantel-Haenszel|||Through Day 29||8.7|-20.2|0.4630
72523562|NCT04315298|144577020|SUPERIORITY||Risk Difference (RD)|-13.3||||0.0971|TWO_SIDED|95.0|-28.2|2.3||P-value based on stratified Cochran-Mantel-Haenszel test using the strata Use of Steroids at Baseline.|Cochran-Mantel-Haenszel|||Through Day 60||2.3|-28.2|0.0971
72523563|NCT04315298|144577020|SUPERIORITY||Risk Difference (RD)|-11.9||||0.1193|TWO_SIDED|95.0|-26.4|2.9||P-value based on stratified Cochran-Mantel-Haenszel test using the strata Use of Steroids at Baseline.|Cochran-Mantel-Haenszel|||Through Day 60||2.9|-26.4|0.1193
72523564|NCT04315298|144577021|SUPERIORITY||Risk Difference (RD)|-0.6||||0.8844|TWO_SIDED|95.0|-9.3|7.7||P-value based on stratified Cochran-Mantel-Haenszel test using the strata Use of Steroids at Baseline.|Cochran-Mantel-Haenszel|||Through Day 29||7.7|-9.3|0.8844
72523565|NCT04315298|144577021|SUPERIORITY||Risk Difference (RD)|5.2||||0.2247|TWO_SIDED|95.0|-3.3|13.0||P-value based on stratified Cochran-Mantel-Haenszel test using the strata Use of Steroids at Baseline.|Cochran-Mantel-Haenszel|||Through Day 29||13.0|-3.3|0.2247
72523566|NCT04315298|144577021|SUPERIORITY||Risk Difference (RD)|-13.3||||0.2102|TWO_SIDED|95.0|-28.2|2.3||P-value based on stratified Cochran-Mantel-Haenszel test using the strata Use of Steroids at Baseline.|Cochran-Mantel-Haenszel|||Through Day 60||2.3|-28.2|0.2102
72523567|NCT04315298|144577021|SUPERIORITY||Risk Difference (RD)|-11.9||||0.8292|TWO_SIDED|95.0|-26.4|2.9||P-value based on stratified Cochran-Mantel-Haenszel test using the strata Use of Steroids at Baseline.|Cochran-Mantel-Haenszel|||Through Day 60||2.9|-26.4|0.8292
72523568|NCT04315298|144577022|SUPERIORITY||Risk Difference (RD)|9.8||||0.2203|TWO_SIDED|95.0|-6.0|24.3||P-value based on stratified Cochran-Mantel-Haenszel test using the strata Use of Steroids at Baseline.|Cochran-Mantel-Haenszel|||||24.3|-6.0|0.2203
72625111|NCT00391716|144779862|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Cumulative means over 12 weeks|ANOVA|||||||<0.001
72523569|NCT04315298|144577022|SUPERIORITY||Risk Difference (RD)|8.8||||0.2483|TWO_SIDED|95.0|-6.1|22.6||P-value based on stratified Cochran-Mantel-Haenszel test using the strata Use of Steroids at Baseline.|Cochran-Mantel-Haenszel|||||22.6|-6.1|0.2483
72523570|NCT04315298|144577023|SUPERIORITY||Risk Difference (RD)|4.1||||0.602|TWO_SIDED|95.0|-11.2|18.5||P-value based on stratified Cochran-Mantel-Haenszel test using the strata Use of Steroids at Baseline.|Cochran-Mantel-Haenszel|||||18.5|-11.2|0.6020
72523571|NCT04315298|144577023|SUPERIORITY||Risk Difference (RD)|5.9||||0.4342|TWO_SIDED|95.0|-8.9|19.5||P-value based on stratified Cochran-Mantel-Haenszel test using the strata Use of Steroids at Baseline.|Cochran-Mantel-Haenszel|||||19.5|-8.9|0.4342
72523572|NCT04315298|144577024|SUPERIORITY||Risk Difference (RD)|5.2||||0.2896|TWO_SIDED|95.0|-4.3|14.7||P-value based on stratified Cochran-Mantel-Haenszel test using the strata Use of Steroids at Baseline.|Cochran-Mantel-Haenszel|||||14.7|-4.3|0.2896
72523573|NCT04315298|144577024|SUPERIORITY||Risk Difference (RD)|-2.9||||0.5355|TWO_SIDED|95.0|-11.8|6.2||P-value based on stratified Cochran-Mantel-Haenszel test using the strata Use of Steroids at Baseline.|Cochran-Mantel-Haenszel|||||6.2|-11.8|0.5355
72523574|NCT04315298|144577025|SUPERIORITY||Risk Difference (RD)|0.5||||0.921|TWO_SIDED|95.0|-9.2|10.2||P-value based on stratified Cochran-Mantel-Haenszel test using the strata Use of Steroids at Baseline.|Cochran-Mantel-Haenszel|||||10.2|-9.2|0.9210
72523575|NCT04315298|144577025|SUPERIORITY||Risk Difference (RD)|-4.7||||0.3174|TWO_SIDED|95.0|-13.8|4.5||P-value based on stratified Cochran-Mantel-Haenszel test using the strata Use of Steroids at Baseline.|Cochran-Mantel-Haenszel|||||4.5|-13.8|0.3174
72523576|NCT04315298|144577026|SUPERIORITY||Hazard Ratio (HR)|1.62||||0.0705|TWO_SIDED|95.0|0.98|2.66||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||||2.66|0.98|0.0705
72523577|NCT04315298|144577026|SUPERIORITY||Hazard Ratio (HR)|1.5||||0.18|TWO_SIDED|95.0|0.92|2.43||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||||2.43|0.92|0.1800
72625112|NCT00391716|144779863|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Cumulative means over 12 weeks|ANOVA|||||||<0.001
72523578|NCT04315298|144577027|SUPERIORITY||Hazard Ratio (HR)|1.18||||0.1831|TWO_SIDED|95.0|0.91|1.52||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||||1.52|0.91|0.1831
72523579|NCT04315298|144577027|SUPERIORITY||Hazard Ratio (HR)|1.05||||0.877|TWO_SIDED|95.0|0.82|1.34||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||||1.34|0.82|0.8770
72523580|NCT04315298|144577028|SUPERIORITY||Hazard Ratio (HR)|0.85||||0.7103|TWO_SIDED|95.0|0.35|2.06||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||||2.06|0.35|0.7103
72523581|NCT04315298|144577029|SUPERIORITY||Hazard Ratio (HR)|1.47||||0.1512|TWO_SIDED|95.0|0.89|2.43||P-value from stratified log-rank test|Log Rank|||||2.43|0.89|0.1512
72523582|NCT04315298|144577029|SUPERIORITY||Hazard Ratio (HR)|1.38||||0.2952|TWO_SIDED|95.0|0.85|2.24||P-value from stratified log-rank test|Log Rank|||||2.24|0.85|0.2952
72523583|NCT04315298|144577030|SUPERIORITY||Hazard Ratio (HR)|1.16||||0.2297|TWO_SIDED|95.0|0.89|1.5||P-value from stratified log-rank test|Log Rank|||||1.50|0.89|0.2297
72523584|NCT04315298|144577030|SUPERIORITY||Hazard Ratio (HR)|1.01||||0.8651|TWO_SIDED|95.0|0.79|1.3||P-value from stratified log-rank test|Log Rank|||||1.30|0.79|0.8651
72523585|NCT04315298|144577031|SUPERIORITY||Risk Difference (RD)|-1.0||||0.8864|TWO_SIDED|95.0|-15.2|12.1||P-value based on stratified Cochran-Mantel-Haenszel test using the strata Use of Steroids at Baseline.|Cochran-Mantel-Haenszel|||||12.1|-15.2|0.8864
72523586|NCT04315298|144577031|SUPERIORITY||Risk Difference (RD)|-2.1||||0.75|TWO_SIDED|95.0|-15.8|10.1||P-value based on stratified Cochran-Mantel-Haenszel test using the strata Use of Steroids at Baseline.|Cochran-Mantel-Haenszel|||||10.1|-15.8|0.7500
72523587|NCT04315298|144577032|SUPERIORITY||Risk Difference (RD)|-1.5||||0.6858|TWO_SIDED|95.0|-9.1|5.6||P-value based on stratified Cochran-Mantel-Haenszel test using the strata Use of Steroids at Baseline.|Cochran-Mantel-Haenszel|||||5.6|-9.1|0.6858
72523588|NCT04315298|144577032|SUPERIORITY||Risk Difference (RD)|0.4||||0.9173|TWO_SIDED|95.0|-7.0|7.0||P-value based on stratified Cochran-Mantel-Haenszel test using the strata Use of Steroids at Baseline.|Cochran-Mantel-Haenszel|||||7.0|-7.0|0.9173
72523589|NCT04315298|144577033|SUPERIORITY||Risk Difference (RD)|4.5||||0.5239|TWO_SIDED|95.0|-9.7|17.3||P-value based on stratified Cochran-Mantel-Haenszel test using the strata Use of Steroids at Baseline.|Cochran-Mantel-Haenszel|||||17.3|-9.7|0.5239
72523590|NCT04315298|144577033|SUPERIORITY||Risk Difference (RD)|3.7||||0.5809|TWO_SIDED|95.0|-10.0|15.6||P-value based on stratified Cochran-Mantel-Haenszel test using the strata Use of Steroids at Baseline.|Cochran-Mantel-Haenszel|||||15.6|-10.0|0.5809
72523591|NCT04315298|144577034|SUPERIORITY||Risk Difference (RD)|0.4||||0.9343|TWO_SIDED|95.0|-9.3|10.1||P-value based on stratified Cochran-Mantel-Haenszel test using the strata Use of Steroids at Baseline.|Cochran-Mantel-Haenszel|||||10.1|-9.3|0.9343
72523592|NCT04315298|144577034|SUPERIORITY||Risk Difference (RD)|-5.0||||0.2822|TWO_SIDED|95.0|-14.1|4.1||P-value based on stratified Cochran-Mantel-Haenszel test using the strata Use of Steroids at Baseline.|Cochran-Mantel-Haenszel|||||4.1|-14.1|0.2822
72523593|NCT04315298|144577035|SUPERIORITY||Hazard Ratio (HR)|1.28||||0.4519|TWO_SIDED|95.0|0.75|2.18||P-value from stratified log-rank test|Log Rank|||||2.18|0.75|0.4519
72523594|NCT04315298|144577035|SUPERIORITY||Hazard Ratio (HR)|1.35||||0.2818|TWO_SIDED|95.0|0.81|2.24||P-value from stratified log-rank test|Log Rank|||||2.24|0.81|0.2818
72523595|NCT04315298|144577036|SUPERIORITY||Hazard Ratio (HR)|1.09||||0.4674|TWO_SIDED|95.0|0.84|1.43||P-value from stratified log-rank test|Log Rank|||||1.43|0.84|0.4674
72523596|NCT04315298|144577036|SUPERIORITY||Hazard Ratio (HR)|1.0||||0.8503|TWO_SIDED|95.0|0.77|1.28||P-value from stratified log-rank test.|Log Rank|||||1.28|0.77|0.8503
72523597|NCT04315298|144577037|SUPERIORITY||Hazard Ratio (HR)|0.79||||0.6156|TWO_SIDED|95.0|0.31|2.02||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||||2.02|0.31|0.6156
72523598|NCT04315298|144577038|SUPERIORITY||Hazard Ratio (HR)|0.65||||0.0843|TWO_SIDED|95.0|0.41|1.03||P-value from stratified log-rank test|Log Rank|||||1.03|0.41|0.0843
72523599|NCT04315298|144577038|SUPERIORITY||Hazard Ratio (HR)|0.69||||0.1576|TWO_SIDED|95.0|0.44|1.07||P-value from stratified log-rank test|Log Rank|||||1.07|0.44|0.1576
72523600|NCT04315298|144577039|SUPERIORITY||Hazard Ratio (HR)|0.81||||0.198|TWO_SIDED|95.0|0.57|1.14||P-value from stratified log-rank test|Log Rank|||||1.14|0.57|0.1980
72523601|NCT04315298|144577039|SUPERIORITY||Hazard Ratio (HR)|1.0||||0.7973|TWO_SIDED|95.0|0.73|1.36||P-value from stratified log-rank test.|Log Rank|||||1.36|0.73|0.7973
72523602|NCT04315298|144577040|SUPERIORITY||Hazard Ratio (HR)|0.6||||0.5023|TWO_SIDED|95.0|0.13|2.75||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||||2.75|0.13|0.5023
72523603|NCT04315298|144577041|SUPERIORITY||Risk Difference (RD)|0.3|STANDARD_ERROR_OF_MEAN|0.26||0.2804|TWO_SIDED|95.0|-0.2|0.8||p-value using two-sample t-test|t-test, 2 sided|||Ventilator-free days up to Day 8||0.8|-0.2|0.2804
72523604|NCT04315298|144577041|SUPERIORITY||Risk Difference (RD)|-0.1|STANDARD_ERROR_OF_MEAN|0.2||0.5023|TWO_SIDED|95.0|-0.5|0.3||p-value using two-sample t-test|t-test, 2 sided|||Ventilator-free days up to Day 8||0.3|-0.5|0.5023
72523605|NCT04315298|144577041|SUPERIORITY||Risk Difference (RD)|0.6|STANDARD_ERROR_OF_MEAN|0.68||0.3821|TWO_SIDED|95.0|-0.7|1.9||p-value using two-sample t-test|t-test, 2 sided|||Ventilator-free days up to Day 15||1.9|-0.7|0.3821
72523606|NCT04315298|144577041|SUPERIORITY||Risk Difference (RD)|0.0|STANDARD_ERROR_OF_MEAN|0.59||0.9737|TWO_SIDED|95.0|-1.2|1.1||p-value using two-sample t-test|t-test, 2 sided|||Ventilator-free days up to Day 15||1.1|-1.2|0.9737
72523607|NCT04315298|144577041|SUPERIORITY||Risk Difference (RD)|1.2|STANDARD_ERROR_OF_MEAN|1.15||0.3179|TWO_SIDED|95.0|-1.1|3.4||p-value using two-sample t-test|t-test, 2 sided|||Ventilator-free days up to Day 22||3.4|-1.1|0.3179
72523608|NCT04315298|144577041|SUPERIORITY||Risk Difference (RD)|0.5|STANDARD_ERROR_OF_MEAN|1.03||0.6302|TWO_SIDED|95.0|-1.5|2.5||p-value using two-sample t-test|t-test, 2 sided|||Ventilator-free days up to Day 22||2.5|-1.5|0.6302
72625113|NCT00391716|144779864|SUPERIORITY_OR_OTHER||||||<|0.003||||||Cumulative means over 12 weeks|ANOVA|||||||<0.003
72570718|NCT02504671|144670143|OTHER||Mean Difference (Net)|2.85||||0.384|TWO_SIDED|95.0|-3.61|9.32||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, Bodily Pain|||9.32|-3.61|0.384
72570719|NCT02504671|144670143|OTHER||Mean Difference (Net)|5.05||||0.105|TWO_SIDED|95.0|-1.07|11.16||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, Bodily Pain|||11.16|-1.07|0.105
72570720|NCT02504671|144670143|OTHER||Mean Difference (Net)|3.21||||0.29|TWO_SIDED|95.0|-2.76|9.17||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, Bodily Pain|||9.17|-2.76|0.290
72570721|NCT02504671|144670143|OTHER||Mean Difference (Net)|-0.51||||0.738|TWO_SIDED|95.0|-3.52|2.5||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, General Health|||2.50|-3.52|0.738
72570722|NCT02504671|144670143|OTHER||Mean Difference (Net)|0.99||||0.513|TWO_SIDED|95.0|-1.99|3.97||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, General Health|||3.97|-1.99|0.513
72570723|NCT02504671|144670143|OTHER||Mean Difference (Net)|0.12||||0.934|TWO_SIDED|95.0|-2.83|3.08||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, General Health|||3.08|-2.83|0.934
72570724|NCT02504671|144670143|OTHER||Mean Difference (Net)|0.63||||0.687|TWO_SIDED|95.0|-2.43|3.68||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, General Health|||3.68|-2.43|0.687
72570725|NCT02504671|144670143|OTHER||Mean Difference (Net)|1.85||||0.233|TWO_SIDED|95.0|-1.2|4.91||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, General Health|||4.91|-1.20|0.233
72570726|NCT02504671|144670143|OTHER||Mean Difference (Net)|0.57||||0.708|TWO_SIDED|95.0|-2.44|3.59||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, General Health|||3.59|-2.44|0.708
72570727|NCT02504671|144670143|OTHER||Mean Difference (Net)|3.29||||0.25|TWO_SIDED|95.0|-2.34|8.93||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, General Health|||8.93|-2.34|0.250
72523609|NCT04315298|144577041|SUPERIORITY||Risk Difference (RD)|1.8|STANDARD_ERROR_OF_MEAN|1.64||0.2862|TWO_SIDED|95.0|-1.5|5.0||p-value using two-sample t-test|t-test, 2 sided|||Ventilator-free days up to Day 29||5.0|-1.5|0.2862
72523610|NCT04315298|144577041|SUPERIORITY||Risk Difference (RD)|1.1|STANDARD_ERROR_OF_MEAN|1.49||0.4509|TWO_SIDED|95.0|-1.8|4.1||p-value using two-sample t-test|t-test, 2 sided|||Ventilator-free days up to Day 29||4.1|-1.8|0.4509
72523611|NCT04315298|144577042|SUPERIORITY||Risk Difference (RD)|-0.2|STANDARD_ERROR_OF_MEAN|0.33||0.564|TWO_SIDED|95.0|-0.8|0.5||p-value using two-sample t-test|t-test, 2 sided|||Ventilator-free days up to Day 8||0.5|-0.8|0.5640
72523612|NCT04315298|144577042|SUPERIORITY||Risk Difference (RD)|-0.4|STANDARD_ERROR_OF_MEAN|0.31||0.1602|TWO_SIDED|95.0|-1.0|0.2||p-value using two-sample t-test|t-test, 2 sided|||Ventilator-free days up to Day 8||0.2|-1.0|0.1602
72523613|NCT04315298|144577042|SUPERIORITY||Risk Difference (RD)|-0.1|STANDARD_ERROR_OF_MEAN|0.64||0.9144|TWO_SIDED|95.0|-1.3|1.2||p-value using two-sample t-test|t-test, 2 sided|||Ventilator-free days up to Day 15||1.2|-1.3|0.9144
72523614|NCT04315298|144577042|SUPERIORITY||Risk Difference (RD)|-0.9|STANDARD_ERROR_OF_MEAN|0.61||0.145|TWO_SIDED|95.0|-2.1|0.3||p-value using two-sample t-test|t-test, 2 sided|||Ventilator-free days up to Day 15||0.3|-2.1|0.1450
72523615|NCT04315298|144577042|SUPERIORITY||Risk Difference (RD)|0.2|STANDARD_ERROR_OF_MEAN|0.95||0.8378|TWO_SIDED|95.0|-1.7|2.1||p-value using two-sample t-test|t-test, 2 sided|||Ventilator-free days up to Day 22||2.1|-1.7|0.8378
72570728|NCT02504671|144670143|OTHER||Mean Difference (Net)|2.76||||0.307|TWO_SIDED|95.0|-2.57|8.09||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, General Health|||8.09|-2.57|0.307
72570729|NCT02504671|144670143|OTHER||Mean Difference (Net)|2.53||||0.345|TWO_SIDED|95.0|-2.74|7.79||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, General Health|||7.79|-2.74|0.345
72570730|NCT02504671|144670143|OTHER||Mean Difference (Net)|0.16||||0.95|TWO_SIDED|95.0|-0.19|0.52||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, Mental Health|||0.52|-0.19|0.950
72570731|NCT02504671|144670143|OTHER||Mean Difference (Net)|0.88||||0.664|TWO_SIDED|95.0|-3.11|4.87||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, Mental Health|||4.87|-3.11|0.664
72570732|NCT02504671|144670143|OTHER||Mean Difference (Net)|-0.01||||0.994|TWO_SIDED|95.0|-3.99|3.96||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, Mental Health|||3.96|-3.99|0.994
72570733|NCT02504671|144670143|OTHER||Mean Difference (Net)|2.6||||0.25|TWO_SIDED|95.0|-1.84|7.03||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, Mental Health|||7.03|-1.84|0.250
72570734|NCT02504671|144670143|OTHER||Mean Difference (Net)|3.21||||0.154|TWO_SIDED|95.0|-1.22|7.64||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, Mental Health|||7.64|-1.22|0.154
72570735|NCT02504671|144670143|OTHER||Mean Difference (Net)|2.5||||0.262|TWO_SIDED|95.0|-1.88|6.89||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, Mental Health|||6.89|-1.88|0.262
72570736|NCT02504671|144670143|OTHER||Mean Difference (Net)|1.32||||0.693|TWO_SIDED|95.0|-5.28|7.93||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, Mental Health|||7.93|-5.28|0.693
72570737|NCT02504671|144670143|OTHER||Mean Difference (Net)|3.28||||0.302|TWO_SIDED|95.0|-2.98|9.54||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, Mental Health|||9.54|-2.98|0.302
72570738|NCT02504671|144670143|OTHER||Mean Difference (Net)|0.61||||0.844|TWO_SIDED|95.0|-5.54|6.77||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, Mental Health|||6.77|-5.54|0.844
72570739|NCT02504671|144670143|OTHER||Mean Difference (Net)|0.66||||0.698|TWO_SIDED|95.0|-2.71|4.04||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, Physical Functioning|||4.04|-2.71|0.698
72570740|NCT02504671|144670143|OTHER||Mean Difference (Net)|2.38||||0.159|TWO_SIDED|95.0|-0.94|5.7||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, Physical Functioning|||5.70|-0.94|0.159
72570741|NCT02504671|144670143|OTHER||Mean Difference (Net)|1.53||||0.36|TWO_SIDED|95.0|-1.76|4.83||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, Physical Functioning|||4.83|-1.76|0.360
72570742|NCT02504671|144670143|OTHER||Mean Difference (Net)|2.82||||0.151|TWO_SIDED|95.0|-1.04|6.69||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, Physical Functioning|||6.69|-1.04|0.151
72570743|NCT02504671|144670143|OTHER||Mean Difference (Net)|3.01||||0.124|TWO_SIDED|95.0|-0.83|6.86||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, Physical Functioning|||6.86|-0.83|0.124
72570744|NCT02504671|144670143|OTHER||Mean Difference (Net)|3.0||||0.12|TWO_SIDED|95.0|-0.79|6.8||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, Physical Functioning|||6.80|-0.79|0.120
72570745|NCT02504671|144670143|OTHER||Mean Difference (Net)|-0.64||||0.814|TWO_SIDED|95.0|-5.98|4.7||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, Physical Functioning|||4.70|-5.98|0.814
72570746|NCT02504671|144670143|OTHER||Mean Difference (Net)|-0.41||||0.873|TWO_SIDED|95.0|-5.49|4.67||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, Physical Functioning|||4.67|-5.49|0.873
72570747|NCT02504671|144670143|OTHER||Mean Difference (Net)|0.23||||0.928|TWO_SIDED|95.0|-4.8|5.26||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, Physical Functioning|||5.26|-4.80|0.928
72570748|NCT02504671|144670143|OTHER||Mean Difference (Net)|-1.29||||0.541|TWO_SIDED|95.0|-5.44|2.86||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, Role Emotional|||2.86|-5.44|0.541
72570749|NCT02504671|144670143|OTHER||Mean Difference (Net)|-1.29||||0.535|TWO_SIDED|95.0|-5.39|2.81||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, Role Emotional|||2.81|-5.39|0.535
72406389|NCT02942017|144321622|SUPERIORITY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.144||0.0406|TWO_SIDED|95.0|-0.58|-0.01|||MMRM|||Insomnia-Middle, Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.01|-0.58|0.0406
72570750|NCT02504671|144670143|OTHER||Mean Difference (Net)|-1.03||||0.62|TWO_SIDED|95.0|-5.1|3.05||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, Role Emotional|||3.05|-5.10|0.620
72570751|NCT02504671|144670143|OTHER||Mean Difference (Net)|0.34||||0.881|TWO_SIDED|95.0|-4.08|4.76||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, Role Emotional|||4.76|-4.08|0.881
72570752|NCT02504671|144670143|OTHER||Mean Difference (Net)|0.66||||0.767|TWO_SIDED|95.0|-3.74|5.07||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12,Role Emotional|||5.07|-3.74|0.767
72570753|NCT02504671|144670143|OTHER||Mean Difference (Net)|0.24||||0.913|TWO_SIDED|95.0|-4.12|4.61||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, Role Emotional|||4.61|-4.12|0.913
72570754|NCT02504671|144670143|OTHER||Mean Difference (Net)|0.91||||0.79|TWO_SIDED|95.0|-5.81|7.63||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, Role Emotional|||7.63|-5.81|0.790
72570755|NCT02504671|144670143|OTHER||Mean Difference (Net)|0.5||||0.876|TWO_SIDED|95.0|-5.86|6.87||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, Role Emotional|||6.87|-5.86|0.876
72570756|NCT02504671|144670143|OTHER||Mean Difference (Net)|-1.3||||0.684|TWO_SIDED|95.0|-7.59|4.99||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, Role Emotional|||4.99|-7.59|0.684
72570757|NCT02504671|144670143|OTHER||Mean Difference (Net)|0.86||||0.588|TWO_SIDED|95.0|-2.28|4.01||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, Role Physical|||4.01|-2.28|0.588
72570758|NCT02504671|144670143|OTHER||Mean Difference (Net)|1.9||||0.229|TWO_SIDED|95.0|-1.21|5.0||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, Role Physical|||5.00|-1.21|0.229
72570759|NCT02504671|144670143|OTHER||Mean Difference (Net)|2.41||||0.125|TWO_SIDED|95.0|-0.67|5.49||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, Role Physical|||5.49|-0.67|0.125
72570760|NCT02504671|144670143|OTHER||Mean Difference (Net)|0.6||||0.736|TWO_SIDED|95.0|-2.92|4.12||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, Role Physical|||4.12|-2.92|0.736
72406390|NCT02942017|144321622|SUPERIORITY||LS Mean Difference|-0.29|STANDARD_ERROR_OF_MEAN|0.132||0.0295|TWO_SIDED|95.0|-0.56|-0.03|||MMRM|||Insomnia-Middle, Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.03|-0.56|0.0295
72523616|NCT04315298|144577042|SUPERIORITY||Risk Difference (RD)|-1.2|STANDARD_ERROR_OF_MEAN|0.89||0.1988|TWO_SIDED|95.0|-2.9|0.6||p-value using two-sample t-test|t-test, 2 sided|||Ventilator-free days up to Day 22||0.6|-2.9|0.1988
72523617|NCT04315298|144577042|SUPERIORITY||Risk Difference (RD)|0.2|STANDARD_ERROR_OF_MEAN|1.26||0.8556|TWO_SIDED|95.0|-2.2|2.7||p-value using two-sample t-test|t-test, 2 sided|||Ventilator-free days up to Day 29||2.7|-2.2|0.8556
72523618|NCT04315298|144577042|SUPERIORITY||Risk Difference (RD)|-1.3|STANDARD_ERROR_OF_MEAN|1.19||0.263|TWO_SIDED|95.0|-3.7|1.0||p-value using two-sample t-test|t-test, 2 sided|||Ventilator-free days up to Day 29||1.0|-3.7|0.2630
72523619|NCT04315298|144577043|SUPERIORITY||Mean Difference (Net)|0.2|STANDARD_ERROR_OF_MEAN|0.18||0.3662|TWO_SIDED|95.0|-0.2|0.5||p-value using two-sample t-test|t-test, 2 sided|||Hospitalized up to Day 8||0.5|-0.2|0.3662
72523620|NCT04315298|144577043|SUPERIORITY||Mean Difference (Net)|0.3|STANDARD_ERROR_OF_MEAN|0.16||0.082|TWO_SIDED|95.0|0.0|0.6||p-value using two-sample t-test|t-test, 2 sided|||Hospitalized up to Day 8||0.6|0.0|0.0820
72523621|NCT04315298|144577043|SUPERIORITY||Mean Difference (Net)|-0.1|STANDARD_ERROR_OF_MEAN|0.37||0.6984|TWO_SIDED|95.0|-0.9|0.6||p-value using two-sample t-test|t-test, 2 sided|||Hospitalized up to Day 15||0.6|-0.9|0.6984
72523622|NCT04315298|144577043|SUPERIORITY||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|0.32||0.9833|TWO_SIDED|95.0|-0.6|0.6||p-value using two-sample t-test|t-test, 2 sided|||Hospitalized up to Day 15||0.6|-0.6|0.9833
72523623|NCT04315298|144577043|SUPERIORITY||Mean Difference (Net)|0.9|STANDARD_ERROR_OF_MEAN|0.56||0.1436|TWO_SIDED|95.0|-0.3|2.0||p-value using two-sample t-test|t-test, 2 sided|||Hospitalized up to Day 22||2.0|-0.3|0.1436
72523624|NCT04315298|144577043|SUPERIORITY||Mean Difference (Net)|0.4|STANDARD_ERROR_OF_MEAN|0.49||0.419|TWO_SIDED|95.0|-0.6|1.4||p-value using two-sample t-test|t-test, 2 sided|||Hospitalized up to Day 22||1.4|-0.6|0.4190
72523625|NCT04315298|144577043|SUPERIORITY||Mean Difference (Net)|0.2|STANDARD_ERROR_OF_MEAN|0.47||0.652|TWO_SIDED|95.0|-0.7|1.2||p-value using two-sample t-test|t-test, 2 sided|||Hospitalized up to Day 29||1.2|-0.7|0.6520
72523626|NCT04315298|144577043|SUPERIORITY||Mean Difference (Net)|-0.1|STANDARD_ERROR_OF_MEAN|0.5||0.801|TWO_SIDED|95.0|-1.1|0.9||p-value using two-sample t-test|t-test, 2 sided|||Hospitalized up to Day 29||0.9|-1.1|0.8010
72523627|NCT04315298|144577044|SUPERIORITY||Mean Difference (Net)|-0.1|STANDARD_ERROR_OF_MEAN|0.16||0.3724|TWO_SIDED|95.0|-0.4|0.2||p-value using two-sample t-test|t-test, 2 sided|||Hospitalized up to Day 8||0.2|-0.4|0.3724
72523628|NCT04315298|144577044|SUPERIORITY||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|0.13||0.7034|TWO_SIDED|95.0|-0.2|0.3||p-value using two-sample t-test|t-test, 2 sided|||Hospitalized up to Day 8||0.3|-0.2|0.7034
72523629|NCT04315298|144577044|SUPERIORITY||Mean Difference (Net)|0.2|STANDARD_ERROR_OF_MEAN|0.28||0.5841|TWO_SIDED|95.0|-0.4|0.7||p-value using two-sample t-test|t-test, 2 sided|||Hospitalized up to Day 15||0.7|-0.4|0.5841
72523630|NCT04315298|144577044|SUPERIORITY||Mean Difference (Net)|0.1|STANDARD_ERROR_OF_MEAN|0.27||0.6648|TWO_SIDED|95.0|-0.4|0.6||p-value using two-sample t-test|t-test, 2 sided|||Hospitalized up to Day 15||0.6|-0.4|0.6648
72523631|NCT04315298|144577044|SUPERIORITY||Mean Difference (Net)|0.3|STANDARD_ERROR_OF_MEAN|0.36||0.4624|TWO_SIDED|95.0|-0.4|1.0||p-value using two-sample t-test|t-test, 2 sided|||Hospitalized up to Day 22||1.0|-0.4|0.4624
72523632|NCT04315298|144577044|SUPERIORITY||Mean Difference (Net)|0.4|STANDARD_ERROR_OF_MEAN|0.32||0.2546|TWO_SIDED|95.0|-0.3|1.0||p-value using two-sample t-test|t-test, 2 sided|||Hospitalized up to Day 22||1.0|-0.3|0.2546
72523633|NCT04315298|144577044|SUPERIORITY||Mean Difference (Net)|-0.2|STANDARD_ERROR_OF_MEAN|0.38||0.5312|TWO_SIDED|95.0|-1.0|0.5||p-value using two-sample t-test|t-test, 2 sided|||Hospitalized up to Day 29||0.5|-1.0|0.5312
72523634|NCT04315298|144577044|SUPERIORITY||Mean Difference (Net)|-0.4|STANDARD_ERROR_OF_MEAN|0.35||0.3039|TWO_SIDED|95.0|-1.1|0.3||p-value using two-sample t-test|t-test, 2 sided|||Hospitalized up to Day 29||0.3|-1.1|0.3039
72523635|NCT01183104|144577073|NON_INFERIORITY_OR_EQUIVALENCE|The pre-defined non-inferiority margin was 0.3%.|LS mean difference|0.11||||0.087|TWO_SIDED|95.0|-0.02|0.24|||ANCOVA|||||0.24|-0.02|0.087
72523636|NCT01183104|144577074|SUPERIORITY_OR_OTHER|||||||0.002|||||||Fisher Exact|||||||0.002
72523637|NCT01183104|144577075|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||||||1.0
72523638|NCT01183104|144577076|SUPERIORITY_OR_OTHER|||||||0.03|||||||ANCOVA|||||||0.030
72523639|NCT01183104|144577077|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANCOVA|||||||<0.001
72523640|NCT01183104|144577078|SUPERIORITY_OR_OTHER|||||||0.043|||||||ANCOVA|||||||0.043
72542530|NCT01010230|144614894|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.29||||0.4|TWO_SIDED|95.0|-0.69|3.11||The threshold for significance was established a priori at alpha=0.05.|ANOVA|Adjusted for sex and tanner stage.||The power estimates were based on two-sided two-sample t-tests. With 30 subjects in each of the two arms and assuming no change in the control arm (0% change) and assuming the common standard deviation (SD) of 6.8%3 we estimated 87% power to detect an improvement of 5.5% change in the intervention arm, with type I error control α=0.05.||3.11|-0.69|0.40
72542531|NCT01010230|144614895|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.67||||0.73|TWO_SIDED|95.0|-2.02|3.33||The threshold for significance was established a priori at alpha=0.05.|ANOVA|Adjusted for sex and tanner stage.||The power estimates were based on two-sided two-sample t-tests. With 30 subjects in each of the two arms and assuming no change in the control arm (0% change) and assuming the common standard deviation (SD) of 6.8%3 we estimated 87% power to detect an improvement of 5.5% change in the intervention arm, with type I error control α=0.05.||3.33|-2.02|0.73
72542532|NCT01010230|144614896|NON_INFERIORITY_OR_EQUIVALENCE|The power calculation was based on the primary aim and is provided above.|Mean Difference (Final Values)|0.2||||0.08|TWO_SIDED|95.0|0.06|0.34||The threshold for significance was established a priori at alpha=0.05.|t-test, 2 sided|||Active and placebo group means were compared with a 2-sample t-test after log-transforming the variable.||0.34|0.06|0.08
72406391|NCT02942017|144321622|SUPERIORITY||LS Mean Difference|-0.23|STANDARD_ERROR_OF_MEAN|0.135||0.0925|TWO_SIDED|95.0|-0.5|0.04|||MMRM|||Insomnia-Middle, Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.04|-0.50|0.0925
72406392|NCT02942017|144321622|SUPERIORITY||LS Mean Difference|-0.21|STANDARD_ERROR_OF_MEAN|0.152||0.1631|TWO_SIDED|95.0|-0.52|0.09|||MMRM|||Insomnia-Middle, Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.09|-0.52|0.1631
72406393|NCT02942017|144321622|SUPERIORITY||LS Mean Difference|-0.23|STANDARD_ERROR_OF_MEAN|0.185||0.2213|TWO_SIDED|95.0|-0.6|0.14|||MMRM|||Insomnia-Middle, Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.14|-0.60|0.2213
72406394|NCT02942017|144321622|SUPERIORITY||LS Mean Difference|0.02|STANDARD_ERROR_OF_MEAN|0.189||0.9175|TWO_SIDED|95.0|-0.36|0.39|||MMRM|||Insomnia-Middle, Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.39|-0.36|0.9175
72406395|NCT02942017|144321622|SUPERIORITY||LS Mean Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.165||0.6763|TWO_SIDED|95.0|-0.4|0.26|||MMRM|||Insomnia-Middle, Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.26|-0.40|0.6763
72406396|NCT02942017|144321622|SUPERIORITY||LS Mean Difference|0.11|STANDARD_ERROR_OF_MEAN|0.121||0.3805|TWO_SIDED|95.0|-0.13|0.35|||MMRM|||Insomnia-Late, Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.35|-0.13|0.3805
72523641|NCT03267511|144577079|OTHER||Difference of Least Mean Square|0.06|STANDARD_ERROR_OF_MEAN|0.128||0.6499|TWO_SIDED|95.0|-0.19|0.31|||ANCOVA|From ANCOVA with treatment as fixed effect and baseline overall MLSI score as a covariate.|||"The reason for entering same analysis for primary and secondary is because statistical analysis was not done separately for primary outcome measure.~The decision was clinical decision at the time of protocol design.There was no comparisons for the primary objective as the main objective was to look at the rank order of the treatments in level of stain reduction after 8 weeks of treatment. This was achieved via the adjusted means and confidence intervals for the means along with plots of MLSI over time. The hypothesis was that the test products would reduce stain to a greater extent than the reference products. Two comparisons of interest were done under secondary and exploratory objectives."|0.31|-0.19|0.6499
72523642|NCT03267511|144577079|OTHER||Difference of Least Square mean|-0.07|STANDARD_ERROR_OF_MEAN|0.128||0.568|TWO_SIDED|95.0|-0.33|0.18|||ANCOVA|From ANCOVA with treatment as fixed effect and baseline overall MLSI score as a covariate.|-0.33 to 0.18|||0.18|-0.33|0.5680
72523643|NCT03267511|144577080|OTHER||Difference of Least Square mean|0.06|STANDARD_ERROR_OF_MEAN|0.128||0.6499|TWO_SIDED|95.0|-0.19|0.31|||ANCOVA|From ANCOVA with treatment as fixed effect and baseline overall MLSI score as a covariate.|Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|||0.31|-0.19|0.6499
72523644|NCT03267511|144577081|OTHER||Difference of Least Square mean|-0.07|STANDARD_ERROR_OF_MEAN|0.128||0.568|TWO_SIDED|95.0|-0.33|0.18|||ANCOVA|From ANCOVA with treatment as fixed effect and baseline overall MLSI score as a covariate.|Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|||0.18|-0.33|0.5680
72523645|NCT04984876|144577100|OTHER||Odds Ratio (OR)|25.83||||0.002|TWO_SIDED|95.0|4.34|506.78|||Regression, Logistic||logistic regression model, including treatment, age subgroup (12 - 17 yrs, 18 - 55 yrs), region as fixed class effects, as well as and log-transformed baseline total IgE at screening and log-transformed MTD at screening DBPCFC as covariates.|||506.78|4.34|0.002
72570761|NCT02504671|144670143|OTHER||Mean Difference (Net)|1.72||||0.338|TWO_SIDED|95.0|-1.8|5.23||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, Role Physical|||5.23|-1.80|0.338
72406397|NCT02942017|144321622|SUPERIORITY||LS Mean Difference|0.07|STANDARD_ERROR_OF_MEAN|0.127||0.6073|TWO_SIDED|95.0|-0.19|0.32|||MMRM|||Insomnia-Late, Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.32|-0.19|0.6073
72523646|NCT04984876|144577100|OTHER||Odds Ratio (OR)|5.1||||0.073|TWO_SIDED|95.0|0.8|100.98|||Regression, Logistic||logistic regression model, including treatment, age subgroup (12 - 17 yrs, 18 - 55 yrs), region as fixed class effects, as well as and log-transformed baseline total IgE at screening and log-transformed MTD at screening DBPCFC as covariates.|||100.98|0.80|0.073
72570762|NCT02504671|144670143|OTHER||Mean Difference (Net)|0.92||||0.6|TWO_SIDED|95.0|-2.55|4.4||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, Role Physical|||4.40|-2.55|0.600
72523647|NCT04984876|144577101|OTHER||Odds Ratio (OR)|9.86||||0.018|TWO_SIDED|95.0|1.69|188.85|||Regression, Logistic||logistic regression model, including treatment, age subgroup (12 - 17 yrs, 18 - 55 yrs), region as fixed class effects, as well as and log-transformed baseline total IgE at screening and log-transformed MTD at screening DBPCFC as covariates.|||188.85|1.69|0.018
72523648|NCT04984876|144577101|OTHER||Odds Ratio (OR)|3.02||||0.164|TWO_SIDED|95.0|0.45|59.93|||Regression, Logistic||logistic regression model, including treatment, age subgroup (12 - 17 yrs, 18 - 55 yrs), region as fixed class effects, as well as and log-transformed baseline total IgE at screening and log-transformed MTD at screening DBPCFC as covariates.|||59.93|0.45|0.164
72523649|NCT04984876|144577102|OTHER||Odds Ratio (OR)|3.47||||0.138|TWO_SIDED|95.0|0.51|70.08|||Regression, Logistic||logistic regression model, including treatment, age subgroup (12 - 17 yrs, 18 - 55 yrs), region as fixed class effects, as well as and log-transformed baseline total IgE at screening and log-transformed MTD at screening DBPCFC as covariates.|||70.08|0.51|0.138
72523650|NCT04984876|144577102|OTHER||Odds Ratio (OR)|2.21||||0.247|TWO_SIDED|95.0|0.3|45.56|||Regression, Logistic||logistic regression model, including treatment, age subgroup (12 - 17 yrs, 18 - 55 yrs), region as fixed class effects, as well as and log-transformed baseline total IgE at screening and log-transformed MTD at screening DBPCFC as covariates.|||45.56|0.30|0.247
72523651|NCT04984876|144577103|OTHER||Odds Ratio (OR)|10.59|||<|0.001|TWO_SIDED|95.0|3.63|31.56|||proportional odds model||proportional odds model adjusting for treatment, age subgroup (12 - 17 yrs, 18 - 55 yrs), log transformed baseline total IgE at screening and region.|||31.56|3.63|<0.001
72523652|NCT04984876|144577103|OTHER||Odds Ratio (OR)|5.05||||0.001|TWO_SIDED|95.0|1.8|14.36|||proportional odds model||proportional odds model adjusting for treatment, age subgroup (12 - 17 yrs, 18 - 55 yrs), log transformed baseline total IgE at screening and region.|||14.36|1.80|0.001
72523653|NCT04984876|144577104|OTHER||Odds Ratio (OR)|4.73||||0.082|TWO_SIDED|95.0|0.74|93.16|||Regression, Logistic||logistic regression model, including treatment, age subgroup (12 - 17 yrs, 18 - 55 yrs), region as fixed class effects, as well as and log-transformed baseline total IgE at screening and log-transformed MTD at screening DBPCFC as covariates.|||93.16|0.74|0.082
72523654|NCT04984876|144577104|OTHER||Odds Ratio (OR)|0.61||||0.632|TWO_SIDED|95.0|0.02|16.43|||Regression, Logistic||logistic regression model, including treatment, age subgroup (12 - 17 yrs, 18 - 55 yrs), region as fixed class effects, as well as and log-transformed baseline total IgE at screening and log-transformed MTD at screening DBPCFC as covariates.|||16.43|0.02|0.632
72523655|NCT04984876|144577109|OTHER||LS Mean difference|-3.77|||<|0.001|TWO_SIDED|95.0|-5.15|-2.4|||ANCOVA||ANCOVA model with treatment group, age subgroup (12 - 17 years, 18 - 55 years), region, log-transformed baseline total IgE at screening and baseline SPT mean wheal diameter (average dilutions peanut protein) as covariates.|||-2.40|-5.15|<0.001
72523656|NCT04984876|144577109|OTHER||LS Mean difference|-4.93|||<|0.001|TWO_SIDED|95.0|-7.77|-2.09|||ANCOVA||ANCOVA model with treatment group, age subgroup (12 - 17 years, 18 - 55 years), region, log-transformed baseline total IgE at screening and baseline SPT mean wheal diameter (average dilutions peanut protein) as covariates.|||-2.09|-7.77|<0.001
72523657|NCT04984876|144577109|OTHER||LS Mean difference|-3.2||||0.015|TWO_SIDED|95.0|-6.08|-0.32|||ANCOVA||ANCOVA model with treatment group, age subgroup (12 - 17 years, 18 - 55 years), region, log-transformed baseline total IgE at screening and baseline SPT mean wheal diameter (average dilutions peanut protein) as covariates.|||-0.32|-6.08|0.015
72570763|NCT02504671|144670143|OTHER||Mean Difference (Net)|1.26||||0.657|TWO_SIDED|95.0|-4.34|6.86||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, Role Physical|||6.86|-4.34|0.657
72570764|NCT02504671|144670143|OTHER||Mean Difference (Net)|-0.12||||0.965|TWO_SIDED|95.0|-5.41|5.17||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, Role Physical|||5.17|-5.41|0.965
72406398|NCT02942017|144321622|SUPERIORITY||LS Mean Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.119||0.7848|TWO_SIDED|95.0|-0.27|0.2|||MMRM|||Insomnia-Late, Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.20|-0.27|0.7848
72406399|NCT02942017|144321622|SUPERIORITY||LS Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.121||0.9038|TWO_SIDED|95.0|-0.25|0.23|||MMRM|||Insomnia-Late, Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.23|-0.25|0.9038
72523658|NCT04984876|144577109|OTHER||LS Mean difference|-1.68||||0.13|TWO_SIDED|95.0|-4.62|1.25|||ANCOVA||ANCOVA model with treatment group, age subgroup (12 - 17 years, 18 - 55 years), region, log-transformed baseline total IgE at screening and baseline SPT mean wheal diameter (average dilutions peanut protein) as covariates.|||1.25|-4.62|0.130
72523659|NCT04984876|144577110|OTHER||LS Mean difference|-0.33||||0.173|TWO_SIDED|95.0|-1.03|0.36|||ANCOVA||ANCOVA with treatment group, baseline PRO scores (FAQLQ) and region as fixed effects and log-transformed total IgE at screening as a covariate|Week 12 Part 1 - Total Score||0.36|-1.03|0.173
72523660|NCT04984876|144577110|OTHER||LS Mean difference|-0.29||||0.202|TWO_SIDED|95.0|-0.96|0.39|||ANCOVA||ANCOVA with treatment group, baseline PRO scores (FAQLQ) and region as fixed effects and log-transformed total IgE at screening as a covariate|Week 12 Part 1 - Total Score||0.39|-0.96|0.202
72570765|NCT02504671|144670143|OTHER||Mean Difference (Net)|1.12||||0.675|TWO_SIDED|95.0|-4.14|6.37||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, Role Physical|||6.37|-4.14|0.675
72570766|NCT02504671|144670143|OTHER||Mean Difference (Net)|-0.32||||0.88|TWO_SIDED|95.0|-4.54|3.89||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, Social Functioning|||3.89|-4.54|0.880
72523661|NCT04984876|144577110|OTHER||LS Mean difference|-0.37||||0.151|TWO_SIDED|95.0|-1.09|0.34|||ANCOVA||ANCOVA with treatment group, baseline PRO scores (FAQLQ) and region as fixed effects and log-transformed total IgE at screening as a covariate|Week 12 Part 1 - Total Score||0.34|-1.09|0.151
72406400|NCT02942017|144321622|SUPERIORITY||LS Mean Difference|0.134|STANDARD_ERROR_OF_MEAN|0.134||0.6869|TWO_SIDED|95.0|-0.32|0.21|||MMRM|||Insomnia-Late, Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.21|-0.32|0.6869
72523662|NCT04984876|144577110|OTHER||LS Mean difference|-0.23||||0.264|TWO_SIDED|95.0|-0.94|0.49|||ANCOVA||ANCOVA with treatment group, baseline PRO scores (FAQLQ) and region as fixed effects and log-transformed total IgE at screening as a covariate|Week 12 Part 1 - Total Score||0.49|-0.94|0.264
72523663|NCT04984876|144577110|OTHER||LS Mean difference|-0.43||||0.123|TWO_SIDED|95.0|-1.16|0.3|||ANCOVA||ANCOVA with treatment group, baseline PRO scores (FAQLQ) and region as fixed effects and log-transformed total IgE at screening as a covariate|Week 12 Part 2 - Total Score||0.30|-1.16|0.123
72523664|NCT04984876|144577110|OTHER||LS Mean difference|-0.23||||0.258|TWO_SIDED|95.0|-0.94|0.47|||ANCOVA||ANCOVA with treatment group, baseline PRO scores (FAQLQ) and region as fixed effects and log-transformed total IgE at screening as a covariate|Week 12 Part 2 - Total Score||0.47|-0.94|0.258
72523665|NCT04984876|144577110|OTHER||LS Mean difference|-0.17||||0.324|TWO_SIDED|95.0|-0.92|0.58|||ANCOVA||ANCOVA with treatment group, baseline PRO scores (FAQLQ) and region as fixed effects and log-transformed total IgE at screening as a covariate|Week 12 Part 2 - Total Score||0.58|-0.92|0.324
72523666|NCT04984876|144577110|OTHER||LS Mean difference|-0.03||||0.473|TWO_SIDED|95.0|-0.78|0.73|||ANCOVA||ANCOVA with treatment group, baseline PRO scores (FAQLQ) and region as fixed effects and log-transformed total IgE at screening as a covariate|Week 12 Part 2 - Total Score||0.73|-0.78|0.473
72523667|NCT04984876|144577111|OTHER||LS Mean difference|0.06||||0.597|TWO_SIDED|95.0|-0.44|0.57|||ANCOVA||ANCOVA with treatment group, baseline PRO scores (FAQLQ) and region as fixed effects and log-transformed total IgE at screening as a covariate|Week 12 Part 1 - Total Score||0.57|-0.44|0.597
72523668|NCT04984876|144577111|OTHER||LS Mean difference|-0.39||||0.064|TWO_SIDED|95.0|-0.89|0.11|||ANCOVA||ANCOVA with treatment group, baseline PRO scores (FAQLQ) and region as fixed effects and log-transformed total IgE at screening as a covariate|Week 12 Part 1 - Total Score||0.11|-0.89|0.064
72523669|NCT04984876|144577111|OTHER||LS Mean difference|-0.22||||0.191|TWO_SIDED|95.0|-0.72|0.28|||ANCOVA||ANCOVA with treatment group, baseline PRO scores (FAQLQ) and region as fixed effects and log-transformed total IgE at screening as a covariate|Week 12 Part 1 - Total Score||0.28|-0.72|0.191
72523670|NCT04984876|144577111|OTHER||LS Mean difference|-0.02||||0.472|TWO_SIDED|95.0|-0.51|0.48|||ANCOVA||ANCOVA with treatment group, baseline PRO scores (FAQLQ) and region as fixed effects and log-transformed total IgE at screening as a covariate|Week 12 Part 1 - Total Score||0.48|-0.51|0.472
72523671|NCT04984876|144577111|OTHER||LS Mean difference|0.03||||0.537|TWO_SIDED|95.0|-0.57|0.62|||ANCOVA||ANCOVA with treatment group, baseline PRO scores (FAQLQ) and region as fixed effects and log-transformed total IgE at screening as a covariate|Week 12 Part 2 - Total Score||0.62|-0.57|0.537
72523672|NCT04984876|144577111|OTHER||LS Mean difference|-0.32||||0.141|TWO_SIDED|95.0|-0.91|0.27|||ANCOVA||ANCOVA with treatment group, baseline PRO scores (FAQLQ) and region as fixed effects and log-transformed total IgE at screening as a covariate|Week 12 Part 2 - Total Score||0.27|-0.91|0.141
72523673|NCT04984876|144577111|OTHER||LS Meand difference|-0.45||||0.063|TWO_SIDED|95.0|-1.04|0.13|||ANCOVA||ANCOVA with treatment group, baseline PRO scores (FAQLQ) and region as fixed effects and log-transformed total IgE at screening as a covariate|Week 12 Part 2 - Total Score||0.13|-1.04|0.063
72523674|NCT04984876|144577111|OTHER||LS Mean difference|-0.1||||0.368|TWO_SIDED|95.0|-0.68|0.48|||ANCOVA||ANCOVA with treatment group, baseline PRO scores (FAQLQ) and region as fixed effects and log-transformed total IgE at screening as a covariate|Week 12 Part 2 - Total Score||0.48|-0.68|0.368
72523675|NCT04984876|144577112|OTHER||LS Mean difference|-0.24||||0.225|TWO_SIDED|95.0|-0.87|0.39|||ANCOVA||ANCOVA with treatment group, baseline PRO scores (FAIM) and region as fixed effects and log-transformed total IgE at screening as a covariate.|Week 12 Part 1 - Total Score||0.39|-0.87|0.225
72523676|NCT04984876|144577112|OTHER||LS Mean difference|-0.32||||0.153|TWO_SIDED|95.0|-0.93|0.3|||ANCOVA||ANCOVA with treatment group, baseline PRO scores (FAIM) and region as fixed effects and log-transformed total IgE at screening as a covariate.|Week 12 Part 1 - Total Score||0.30|-0.93|0.153
72523677|NCT04984876|144577112|OTHER||LS Mean difference|-0.3||||0.179|TWO_SIDED|95.0|-0.95|0.34|||ANCOVA||ANCOVA with treatment group, baseline PRO scores (FAIM) and region as fixed effects and log-transformed total IgE at screening as a covariate.|Week 12 Part 1 - Total Score||0.34|-0.95|0.179
72523678|NCT04984876|144577112|OTHER||LS Mean difference|0.11||||0.631|TWO_SIDED|95.0|-0.55|0.77|||ANCOVA||ANCOVA with treatment group, baseline PRO scores (FAIM) and region as fixed effects and log-transformed total IgE at screening as a covariate.|Week 12 Part 1 - Total Score||0.77|-0.55|0.631
72523679|NCT04984876|144577112|OTHER||LS Mean difference|-0.52||||0.06|TWO_SIDED|95.0|-1.18|0.14|||ANCOVA||ANCOVA with treatment group, baseline PRO scores (FAIM) and region as fixed effects and log-transformed total IgE at screening as a covariate.|Week 12 Part 2 - Total Score||0.14|-1.18|0.060
72523680|NCT04984876|144577112|OTHER||LS Mean difference|-0.08||||0.404|TWO_SIDED|95.0|-0.72|0.56|||ANCOVA||ANCOVA with treatment group, baseline PRO scores (FAIM) and region as fixed effects and log-transformed total IgE at screening as a covariate.|Week 12 Part 2 - Total Score||0.56|-0.72|0.404
72523681|NCT04984876|144577112|OTHER||LS Mean difference|-0.38||||0.135|TWO_SIDED|95.0|-1.06|0.3|||ANCOVA||ANCOVA with treatment group, baseline PRO scores (FAIM) and region as fixed effects and log-transformed total IgE at screening as a covariate.|Week 12 Part 2 - Total Score||0.30|-1.06|0.135
72523682|NCT04984876|144577112|OTHER||LS Mean difference|0.01||||0.514|TWO_SIDED|95.0|-0.7|0.72|||ANCOVA||ANCOVA with treatment group, baseline PRO scores (FAIM) and region as fixed effects and log-transformed total IgE at screening as a covariate.|Week 12 Part 2 - Total Score||0.72|-0.70|0.514
72523683|NCT04984876|144577113|OTHER||LS Mean difference|0.04||||0.574|TWO_SIDED|95.0|-0.42|0.51|||ANCOVA||ANCOVA with treatment group, baseline PRO scores (FAIM) and region as fixed effects and log-transformed total IgE at screening as a covariate.|Week 12 Part 1 - Total Score||0.51|-0.42|0.574
72570767|NCT02504671|144670143|OTHER||Mean Difference (Net)|3.17||||0.135|TWO_SIDED|95.0|-1.0|7.33||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, Social Functioning|||7.33|-1.00|0.135
72570768|NCT02504671|144670143|OTHER||Mean Difference (Net)|0.57||||0.785|TWO_SIDED|95.0|-3.56|4.71||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, Social Functioning|||4.71|-3.56|0.785
72523684|NCT04984876|144577113|OTHER||LS Mean difference|-0.37||||0.056|TWO_SIDED|95.0|-0.83|0.09|||ANCOVA||ANCOVA with treatment group, baseline PRO scores (FAIM) and region as fixed effects and log-transformed total IgE at screening as a covariate.|Week 12 Part 1 - Total Score||0.09|-0.83|0.056
72523685|NCT04984876|144577113|OTHER||LS Mean difference|-0.36||||0.069|TWO_SIDED|95.0|-0.83|0.12|||ANCOVA||ANCOVA with treatment group, baseline PRO scores (FAIM) and region as fixed effects and log-transformed total IgE at screening as a covariate.|Week 12 Part 1 - Total Score||0.12|-0.83|0.069
72523686|NCT04984876|144577113|OTHER||LS Mean difference|-0.19||||0.205|TWO_SIDED|95.0|-0.65|0.27|||ANCOVA||ANCOVA with treatment group, baseline PRO scores (FAIM) and region as fixed effects and log-transformed total IgE at screening as a covariate.|Week 12 Part 1 - Total Score||0.27|-0.65|0.205
72523687|NCT04984876|144577113|OTHER||LS Mean difference|-0.2||||0.248|TWO_SIDED|95.0|-0.76|0.37|||ANCOVA||ANCOVA with treatment group, baseline PRO scores (FAIM) and region as fixed effects and log-transformed total IgE at screening as a covariate.|Week 12 Part 2 - Total Score||0.37|-0.76|0.248
72523688|NCT04984876|144577113|OTHER||LS Mean difference|-0.42||||0.071|TWO_SIDED|95.0|-0.98|0.14|||ANCOVA||ANCOVA with treatment group, baseline PRO scores (FAIM) and region as fixed effects and log-transformed total IgE at screening as a covariate.|Week 12 Part 2 - Total Score||0.14|-0.98|0.071
72523689|NCT04984876|144577113|OTHER||LS Mean difference|-0.49||||0.048|TWO_SIDED|95.0|-1.06|0.09|||ANCOVA||ANCOVA with treatment group, baseline PRO scores (FAIM) and region as fixed effects and log-transformed total IgE at screening as a covariate.|Week 12 Part 2 - Total Score||0.09|-1.06|0.048
72523690|NCT04984876|144577113|OTHER||LS Mean difference|-0.3||||0.142|TWO_SIDED|95.0|-0.85|0.25|||ANCOVA||ANCOVA with treatment group, baseline PRO scores (FAIM) and region as fixed effects and log-transformed total IgE at screening as a covariate.|Week 12 Part 2 - Total Score||0.25|-0.85|0.142
72523691|NCT01462045|144577119|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.6|STANDARD_ERROR_OF_MEAN|5.7|<|0.01|TWO_SIDED|95.0|-25.6|-1.6|||t-test, 2 sided|||||-1.6|-25.6|<0.01
72406401|NCT02942017|144321622|SUPERIORITY||LS Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.139||0.9272|TWO_SIDED|95.0|-0.26|0.29|||MMRM|||Insomnia-Late, Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.29|-0.26|0.9272
72523692|NCT01462045|144577120|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.8|STANDARD_ERROR_OF_MEAN|2.4|<|0.01|TWO_SIDED|95.0|0.83|10.8|||t-test, 2 sided|||||10.8|0.83|<0.01
72523693|NCT01193049|144577121|SUPERIORITY_OR_OTHER||GM FR from Placebo: SP|0.25||||0.001|TWO_SIDED|90.0|0.14|0.46||1-sided p-value, α = 0.05|ANOVA|||GM Fold Reduction (FR) is the GM of individual FC(Prednisone)/FC (Placebo) from SP.||0.46|0.14|0.001
72523694|NCT01193049|144577121|SUPERIORITY_OR_OTHER||GM FR from Placebo : NE|0.2|||<|0.001|TWO_SIDED|90.0|0.13|0.3||1-sided p value, α = 0.05|ANOVA|||GM FR is the GM of individual FC(Prednisone)/FC(Placebo) from NE.||0.30|0.13|<0.001
72523695|NCT01193049|144577121|SUPERIORITY_OR_OTHER||Correlation FC from BL: SP vs NE|0.2||||0.553||||||Unadjusted for Baseline and Period Effects|Pearson's correlation coefficient|||Correlation between SP and NE of FC from BL in IL-5 after placebo treatment.||||0.553
72523696|NCT01193049|144577121|SUPERIORITY_OR_OTHER||Correlation FR from Placebo :SP vs NE|-0.02||||0.964||||||Unadjusted for Baseline and Period Effects|Pearson's correlation coefficient|||Correlation between SP and NE of FR from placebo in IL-5 after prednisone treatment.||||0.964
72523697|NCT01193049|144577122|SUPERIORITY_OR_OTHER||GM FR from Placebo: SP|0.27||||0.009|TWO_SIDED|90.0|0.12|0.62||1-sided p-value, α = 0.05|ANOVA|||GM FR is the GM of individual FC(Prednisone)/FC (Placebo) from SP.||0.62|0.12|0.009
72523698|NCT01193049|144577122|SUPERIORITY_OR_OTHER||GM FR from Placebo : NE|0.31|||<|0.001|TWO_SIDED|90.0|0.22|0.43||1-sided p-value, α = 0.05|ANOVA|||GM FR is the GM of individual FC Prednisone)/FC(Placebo) from NE.||0.43|0.22|<0.001
72523699|NCT01193049|144577122|SUPERIORITY_OR_OTHER||Correlation FC from BL: SP vs NE|-0.02||||0.962||||||Unadjusted for Baseline and Period Effects|Pearson's correlation coefficient|||Correlation between SP and NE of FC from BL in IL-13 after placebo treatment.||||0.962
72523700|NCT01193049|144577122|SUPERIORITY_OR_OTHER||Correlation FR from Placebo: SP vs NE|0.07||||0.83||||||Unadjusted for Baseline and Period Effects|Pearson's correlation coefficient|||Correlation between SP and NE of FR from placebo in IL-13 after prednisone treatment.||||0.83
72523701|NCT01193049|144577123|SUPERIORITY_OR_OTHER||GM FR from Placebo: SP|0.8||||0.258|TWO_SIDED|90.0|0.43|1.47||1-sided p-value, α = 0.05|ANOVA|||GM FR from Placebo is the GM of individual FC (Prednisone)/FC (Placebo) from SP.||1.47|0.43|0.258
72523702|NCT01193049|144577123|SUPERIORITY_OR_OTHER||GM FR from Placebo: NE|1.08||||0.681|TWO_SIDED|90.0|0.8|1.46||1-sided p-value, α = 0.05|ANOVA|||GM FR from Placebo is the GM of individual FC (Prednisone)/FC (Placebo) from NE.||1.46|0.80|0.681
72523703|NCT01193049|144577124|SUPERIORITY_OR_OTHER||GM FR from Placebo:SP|0.61||||0.117|TWO_SIDED|90.0|0.3|1.24||1-sided p-value, α = 0.05|ANOVA|||GM FR from Placebo is the GM of individual FC (Prednisone)/FC (Placebo) from SP.||1.24|0.30|0.117
72523704|NCT01193049|144577124|SUPERIORITY_OR_OTHER||GM FR from Placebo: NE|0.64||||0.011|TWO_SIDED|90.0|0.47|0.86||1-sided p-value, α = 0.05|ANOVA|||GM FR from Placebo is the GM of individual FC (Prednisone)/FC (Placebo) from NE.||0.86|0.47|0.011
72523705|NCT01193049|144577126|SUPERIORITY_OR_OTHER||GM FR from Placebo: IL-5|1.51||||0.01|TWO_SIDED|90.0|1.15|1.99||1-sided p-value, α = 0.05|ANOVA|||GM FR from Placebo is the GM of individual FC (Prednisone)/FC (Placebo) for IL-5.||1.99|1.15|0.010
72570769|NCT02504671|144670143|OTHER||Mean Difference (Net)|0.55||||0.797|TWO_SIDED|95.0|-3.69|4.8||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, Social Functioning|||4.80|-3.69|0.797
72406402|NCT02942017|144321622|SUPERIORITY||LS Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.131||0.6931|TWO_SIDED|95.0|-0.31|0.21|||MMRM|||Insomnia-Late, Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.21|-0.31|0.6931
72523706|NCT01193049|144577126|SUPERIORITY_OR_OTHER||GM FR from Placebo: IL-13|1.35||||0.02|TWO_SIDED|90.0|1.07|1.71||1-sided p-value, α = 0.05|ANOVA|||GM FR from Placebo is the GM of individual FC(Prednisone)/FC (Placebo) for IL-13.||1.71|1.07|0.020
72523707|NCT01193049|144577127|SUPERIORITY_OR_OTHER||GM FR from Placebo: SP|0.82||||0.119|TWO_SIDED|90.0|0.62|1.09||1-sided p-value, α = 0.05|ANOVA|||GM FR from Placebo is the GM of individual FC (Prednisone)/FC (Placebo) in IL-17 from SP.||1.09|0.62|0.119
72523708|NCT01193049|144577127|SUPERIORITY_OR_OTHER||GM FR from Placebo: NE|0.68||||0.103|TWO_SIDED|90.0|0.41|1.14||1-sided p-value, α = 0.05|ANOVA|||GM FR from Placebo is the GM of individual FC (Prednisone)/FC (Placebo) in IL-17 from NE.||1.14|0.41|0.103
72523709|NCT01193049|144577128|SUPERIORITY_OR_OTHER||GM FR from Placebo: SP|0.6||||0.003|TWO_SIDED|90.0|0.46|0.77||1-sided p-value, α = 0.05|ANOVA|||GM FR from Placebo is the GM of individual FC (Prednisone)/FC (Placebo) in IL-1β from SP.||0.77|0.46|0.003
72523710|NCT01193049|144577128|SUPERIORITY_OR_OTHER||GM FR from Placebo: NE|0.49||||0.036|TWO_SIDED|90.0|0.26|0.93||1-sided p-value, α = 0.05|ANOVA|||GM FR from Placebo is the GM of individual FC(Prednisone)/FC (Placebo) in IL-1β from NE.||0.93|0.26|0.036
72523711|NCT01193049|144577129|SUPERIORITY_OR_OTHER||GM FR from Placebo: SP|0.7||||0.143|TWO_SIDED|90.0|0.4|1.24||1-sided p-value, α = 0.05|ANOVA|||GM FR from Placebo is the GM of individual FC(Prednisone)/FC (Placebo) in MIP-1β from SP.||1.24|0.40|0.143
72523712|NCT01193049|144577129|SUPERIORITY_OR_OTHER||GM FR from Placebo: NE|0.61||||0.056|TWO_SIDED|90.0|0.37|1.02||1-sided p-value, α = 0.05|ANOVA|||GM FR from Placebo is the GM of individual FC (Prednisone)/FC (Placebo) in MIP-1β from NE.||1.02|0.37|0.056
72523713|NCT02436915|144577138|EQUIVALENCE|We hypothesized that the real tDCS would improve the performance of TUG (i.e., greater percent decrease of time to complete TUG from baseline to follow ups) as compared to the sham tDCS.||||||0.24|||||||ANOVA|||||||0.24
72523714|NCT02436915|144577139|EQUIVALENCE|We hypothesized that the real tDCS would improve the MoCA score (i.e., greater percent increase decrease of MoCA score from baseline to follow ups) as compared to the sham tDCS.||||||0.03|||||||ANOVA|||||||0.03
72523715|NCT02436915|144577140|EQUIVALENCE|We hypothesized that the real tDCS would improve the dual task performance of walking (i.e., greater percent decrease of dual task cost to walking speed from baseline to follow ups) as compared to the sham tDCS.||||||0.37|||||||ANOVA|||||||0.37
72523716|NCT02436915|144577141|EQUIVALENCE|We hypothesized that the real tDCS would improve the performance of dual task standing (i.e., greater percent decrease of dual task cost to standing sway speed from baseline to follow ups) as compared to the sham tDCS.||||||0.004|||||||ANOVA|||||||0.004
72523717|NCT02436915|144577142|EQUIVALENCE|We hypothesized that the real tDCS would reduce the depression (i.e., greater percent decrease of GDS score from baseline to follow ups) as compared to the sham tDCS.||||||0.37|||||||ANOVA|||||||0.37
72625114|NCT00934180|144779898|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Ratio of Geometric Means|103.0||||||90.0|95.1|111.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||111|95.1|
72625115|NCT00934180|144779899|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Ratio of Geometric Means|101.0||||||90.0|95.3|107.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||107|95.3|
72523718|NCT02436915|144577143|EQUIVALENCE|We hypothesized that the real tDCS would improve the performance of TMT (i.e., greater percent decrease of time to complete TMT from baseline to follow ups) as compared to the sham tDCS.||||||0.54|||||||ANOVA|||||||0.54
72523719|NCT02436915|144577144|EQUIVALENCE|We hypothesized that the real tDCS would improve the performance of dual task standing (i.e., greater percent decrease of dual task cost to standing postural sway area from baseline to follow ups) as compared to the sham tDCS.||||||0.0007|||||||ANOVA|||||||0.0007
72523720|NCT02436915|144577145|EQUIVALENCE|We hypothesized that the real tDCS would improve the performance of walking (i.e., greater percent decrease of dual task cost to stride time from baseline to follow ups) as compared to the sham tDCS.||||||0.04|||||||ANOVA|||||||0.04
72523721|NCT02579863|144577159|SUPERIORITY||Hazard Ratio (HR)|0.9||||0.33475|TWO_SIDED|95.0|0.56|1.45|||Log Rank|One-sided p-value based on Stratified log-rank test.|Based on Cox regression model with treatment as a covariate stratified by Age (\<75 years vs \>= 75 years) and ISS stage (I or II vs. III).|||1.45|0.56|0.33475
72523722|NCT02579863|144577160|SUPERIORITY||Hazard Ratio (HR)|1.22||||0.83416|TWO_SIDED|95.0|0.81|1.84|||Stratified log-rank test||"Based on Cox regression model with treatment as a covariate stratified by Age (\<75 years vs \>= 75 years) and ISS stage (I or II vs. III)."|||1.84|0.81|0.83416
72523723|NCT02579863|144577161|SUPERIORITY||Difference in % vs SOC|5.8||||0.13102|TWO_SIDED|95.0|-4.3|15.8|||One-sided p-value for testing|H0: difference in % =0 versus H1: difference in % \> 0.|||Based on Miettinen \& Nurminen method stratified by 'Age' (\<75 years vs \>= 75 years) and 'ISS stage' (I or II vs. III); If there were no participants in one of the treatment groups involved in a comparison for a particular stratum, then that stratum was excluded from the treatment comparison.|15.8|-4.3|0.13102
72523724|NCT00762528|144577190|SUPERIORITY_OR_OTHER||||||<|0.05|ONE_SIDED|95.0|||||ANOVA|||The null hypothesis states that there is no difference between groups.||||<0.05
72523725|NCT00762528|144577191|SUPERIORITY_OR_OTHER||||||<|0.05|ONE_SIDED|95.0|||||ANOVA|||The null hypothesis states that there is no difference between groups.||||<0.05
72523726|NCT00762528|144577192|SUPERIORITY_OR_OTHER||||||<|0.05|ONE_SIDED|95.0|||||ANOVA|||The null hypothesis states that there is no difference between groups.||||<0.05
72523727|NCT00762528|144577193|SUPERIORITY_OR_OTHER||||||<|0.05|ONE_SIDED|95.0|||||ANOVA|||The null hypothesis states that there is no difference between groups.||||<0.05
72523728|NCT00762528|144577194|SUPERIORITY_OR_OTHER||||||<|0.05|ONE_SIDED|95.0|||||ANOVA|||The null hypothesis states that there is no difference between groups.||||<0.05
72523729|NCT00762528|144577195|SUPERIORITY_OR_OTHER||||||<|0.05|ONE_SIDED|95.0|||||ANOVA|||The null hypothesis states that there is no difference between groups.||||<0.05
72523730|NCT00762528|144577196|SUPERIORITY_OR_OTHER||||||<|0.05|ONE_SIDED|95.0|||||ANOVA|||The null hypothesis states that there is no difference between groups.||||<0.05
72523731|NCT00762528|144577197|SUPERIORITY_OR_OTHER||||||<|0.05|ONE_SIDED|95.0|||||ANOVA|||The null hypothesis states that there is no difference between groups.||||<0.05
72523732|NCT02658149|144577199|OTHER|||||||0.036|||||||Wilcoxon (Mann-Whitney)|||||||0.036
72523733|NCT02658149|144577200|OTHER|||||||0.204|||||||Wilcoxon (Mann-Whitney)|||||||0.204
72523734|NCT02658149|144577201|OTHER|||||||1|||||||Wilcoxon (Mann-Whitney)|||||||1.0
72523735|NCT02658149|144577202|OTHER|||||||0.741|||||||t-test, 2 sided|||||||0.741
72523736|NCT02658149|144577203|OTHER|||||||1|||||||t-test, 2 sided|||||||1.0
72523737|NCT03053401|144577214|OTHER|Test of difference was conducted.||||||0.026|||||||Wilcoxon (Mann-Whitney)|||||||0.026
72523738|NCT03053401|144577215|OTHER|||||||0.762||||||Alpha = 0.025 for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.762
72523739|NCT03053401|144577215|OTHER|||||||0.41||||||Alpha = 0.025 for multiple comparisons.|Wilcoxon Rank Sum Test with Exact Option|||||||0.410
72523740|NCT03053401|144577216|OTHER|Test of Difference conducted.||||||0.454|||||||t-test, 2 sided|||||||0.454
72625116|NCT00934180|144779900|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Ratio of Geometric Means|101.0||||||90.0|95.2|108.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||108|95.2|
72625117|NCT00835172|144779901|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Geometric Test/Ref Ratio x 100|102.0||||||90.0|92.1|112.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||112|92.1|
72523741|NCT01804842|144577224|SUPERIORITY_OR_OTHER||% Ratio of LS Means|71.7||||0.0018|TWO_SIDED|90.0|61.14|84.01|||ANOVA|Included treatment, sequence, and period and as fixed effects and subject nested within sequence as a random effect.||1000 mg Met DR qPM is the denominator for the % ratio of least squares (LS) means and the comparator for the p-values.||84.01|61.14|0.0018
72523742|NCT01804842|144577224|SUPERIORITY_OR_OTHER||% Ratio of LS Means|71.5||||0.002|TWO_SIDED|90.0|60.85|84.09|||ANOVA|Included treatment, sequence, and period and as fixed effects and subject nested within sequence as a random effect.||500 mg Met DR BID is the denominator for the % ratio of LS means and the comparator for the p-values.||84.09|60.85|0.0020
72523743|NCT01804842|144577224|SUPERIORITY_OR_OTHER||% Ratio of LS Means|99.8||||0.9844|TWO_SIDED|90.0|84.91|117.33|||ANOVA|Included treatment, sequence, and period and as fixed effects and subject nested within sequence as a random effect.||500 mg Met DR BID is the denominator for the % ratio of LS means and the comparator for the p-values.||117.33|84.91|0.9844
72523744|NCT01804842|144577225|SUPERIORITY_OR_OTHER||% Ratio of LS Means|83.8||||0.1595|TWO_SIDED|90.0|68.1|103.23|||ANOVA|Included treatment, sequence, and period and as fixed effects and subject nested within sequence as a random effect.||1000 mg Met DR qPM is the denominator for the % ratio of LS means and the comparator for the p-values.||103.23|68.10|0.1595
72523745|NCT01804842|144577225|SUPERIORITY_OR_OTHER||% Ratio of LS Means|111.3||||0.3867|TWO_SIDED|90.0|90.37|136.99|||ANOVA|Included treatment, sequence, and period and as fixed effects and subject nested within sequence as a random effect.||500 mg Met DR BID is the denominator for the % ratio of LS means and the comparator for the p-values.||136.99|90.37|0.3867
72523746|NCT01804842|144577225|SUPERIORITY_OR_OTHER||% Ratio of LS Means|132.7||||0.0294|TWO_SIDED|90.0|107.78|163.39|||ANOVA|Included treatment, sequence, and period and as fixed effects and subject nested within sequence as a random effect.||500 mg Met DR BID is the denominator for the % ratio of LS means and the comparator for the p-values.||163.39|107.78|0.0294
72523747|NCT01804842|144577226|SUPERIORITY_OR_OTHER||% Ratio of LS Means|91.0||||0.0028|TWO_SIDED|95.0|85.7|96.67|||ANOVA|Treatment, sequence, period, status (on-/pre-treatment) and treatment\*status as fixed effects and subject nested within sequence as a random effect.||Pretreatment value is the denominator for the % ratio of LS means and the comparator for the p-values.||96.67|85.70|0.0028
72523748|NCT01804842|144577226|SUPERIORITY_OR_OTHER||% Ratio of LS Means|90.9||||0.0024|TWO_SIDED|95.0|85.58|96.53|||ANOVA|Treatment, sequence, period, status (on-/pre-treatment) and treatment\*status as fixed effects and subject nested within sequence as a random effect.||Pretreatment value is the denominator for the % ratio of LS means and the comparator for the p-values.||96.53|85.58|0.0024
72523749|NCT01804842|144577226|SUPERIORITY_OR_OTHER||% Ratio of LS Means|95.1||||0.0992|TWO_SIDED|95.0|89.54|100.99|||ANOVA|Treatment, sequence, period, status (on-/pre-treatment) and treatment\*status as fixed effects and subject nested within sequence as a random effect.||Pretreatment value is the denominator for the % ratio of LS means and the comparator for the p-values.||100.99|89.54|0.0992
72523750|NCT01804842|144577227|SUPERIORITY_OR_OTHER||% Ratio of LS Means|90.4||||0.0006|TWO_SIDED|95.0|85.55|95.56|||ANOVA|Treatment, sequence, period, status (on-/pre-treatment) and treatment\*status as fixed effects and subject nested within sequence as a random effect.||Pretreatment value is the denominator for the % ratio of LS means and the comparator for the p-values.||95.56|85.55|0.0006
72523751|NCT01804842|144577227|SUPERIORITY_OR_OTHER||% Ratio of LS Means|90.5||||0.0007|TWO_SIDED|95.0|85.65|95.67|||ANOVA|Treatment, sequence, period, status (on-/pre-treatment) and treatment\*status as fixed effects and subject nested within sequence as a random effect.||Pretreatment value is the denominator for the % ratio of LS means and the comparator for the p-values.||95.67|85.65|0.0007
72523752|NCT01804842|144577227|SUPERIORITY_OR_OTHER||% Ratio of LS Means|94.3||||0.0389|TWO_SIDED|95.0|89.24|99.69|||ANOVA|Treatment, sequence, period, status (on-/pre-treatment) and treatment\*status as fixed effects and subject nested within sequence as a random effect.||Pretreatment value is the denominator for the % ratio of LS means and the comparator for the p-values.||99.69|89.24|0.0389
72523753|NCT03887052|144577228|NON_INFERIORITY|The primary endpoint was performed as a one-sided test with a 0.025 significance level of the null hypothesis (H0) that the WCD false positive shock alarm rate per patient-day for the study device was equal to or greater than the comparator rate (0.29). A random-effects Poisson regression model was fit with the number of false-positive shock alarms for each patient as the outcome, the logarithm of days of wear as an offset, and random site effect.|||||<|0.001||||||"Hypotheses:~H0: p1 ≥ 0.29 H1: p1 \< 0.29~where p1 = A-WCD False Positive Alarm Rate"|One-sided non-inferiority|Poisson Regression Analysis||The analysis was based on the cohort of 130 patients with three false-positive shock alarms occurring over a total of 3501 patient-days (500 weeks), or 0.0060 false-positive shock alarms per patient-week. The Poisson distribution was used to model the results and calculate the false-positive shock alarm rate.||||<0.001
72523754|NCT04222673|144577260|SUPERIORITY|Given the small sample size and recommendations for pilot studies, quantitative analyses were descriptive (frequencies, means) and based on the Reliable Change Index (RCI) for each participant for each outcome measure. The RCI is used to determine whether pre- to post- score differences are statistically reliable and to categorize changes as either improved, deteriorated, or indeterminate. A statistical threshold of RCI score z = + 1.96 and p \< .05 was used to establish clinical significance.||||||0.05|||||||the Reliable Change Index|||||||.05
72523755|NCT04222673|144577261|SUPERIORITY|Given the small sample size and recommendations for pilot studies, quantitative analyses were descriptive (frequencies, means) and based on the Reliable Change Index (RCI) for each participant for each outcome measure. The RCI is used to determine whether pre- to post- score differences are statistically reliable and to categorize changes as either improved, deteriorated, or indeterminate. A statistical threshold of RCI score z = + 1.96 and p \< .05 was used to establish clinical significance.||||||0.05|||||||the Reliable Change Index|||||||.05
72523756|NCT04222673|144577262|OTHER|||||||0.05|||||||the Reliable Change Index|||Given the small sample size and recommendations for pilot studies, quantitative analyses were descriptive (frequencies, means) and based on the Reliable Change Index (RCI) for each participant for each outcome measure. The RCI is used to determine whether pre- to post- score differences are statistically reliable and to categorize changes as either improved, deteriorated, or indeterminate. A statistical threshold of RCI score z = + 1.96 and p \< .05 was used to establish clinical significance.||||.05
72523757|NCT04222673|144577263|SUPERIORITY|||||||0.05|||||||the Reliable Change Index|||Given the small sample size and recommendations for pilot studies, quantitative analyses were descriptive (frequencies, means) and based on the Reliable Change Index (RCI) for each participant for each outcome measure. The RCI is used to determine whether pre- to post- score differences are statistically reliable and to categorize changes as either improved, deteriorated, or indeterminate. A statistical threshold of RCI score z = + 1.96 and p \< .05 was used to establish clinical significance.||||.05
72523758|NCT04222673|144577264|SUPERIORITY|||||||0.05|||||||the Reliable Change Index|||Given the small sample size and recommendations for pilot studies, quantitative analyses were descriptive (frequencies, means) and based on the Reliable Change Index (RCI) for each participant for each outcome measure. The RCI is used to determine whether pre- to post- score differences are statistically reliable and to categorize changes as either improved, deteriorated, or indeterminate. A statistical threshold of RCI score z = + 1.96 and p \< .05 was used to establish clinical significance.||||.05
72523759|NCT04222673|144577265|SUPERIORITY|Given the small sample size and recommendations for pilot studies, quantitative analyses were descriptive (frequencies, means) and based on the Reliable Change Index (RCI) for each participant for each outcome measure. The RCI is used to determine whether pre- to post- score differences are statistically reliable and to categorize changes as either improved, deteriorated, or indeterminate. A statistical threshold of RCI score z = + 1.96 and p \< .05 was used to establish clinical significance.||||||0.05|||||||the Reliable Change Index|||||||.05
72523760|NCT04222673|144577266|SUPERIORITY|||||||0.05|||||||the Reliable Change Index|||Given the small sample size and recommendations for pilot studies, quantitative analyses were descriptive (frequencies, means) and based on the Reliable Change Index (RCI) for each participant for each outcome measure. The RCI is used to determine whether pre- to post- score differences are statistically reliable and to categorize changes as either improved, deteriorated, or indeterminate. A statistical threshold of RCI score z = + 1.96 and p \< .05 was used to establish clinical significance.||||.05
72523761|NCT04222673|144577267|SUPERIORITY|||||||0.05|||||||the Reliable Change Index|||Given the small sample size and recommendations for pilot studies, quantitative analyses were descriptive (frequencies, means) and based on the Reliable Change Index (RCI) for each participant for each outcome measure. The RCI is used to determine whether pre- to post- score differences are statistically reliable and to categorize changes as either improved, deteriorated, or indeterminate. A statistical threshold of RCI score z = + 1.96 and p \< .05 was used to establish clinical significance.||||.05
72523763|NCT02352090|144577276|OTHER|||||||0.27|||||||ANOVA|||||||0.27
72523764|NCT01849562|144577287|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|50.0|||||TWO_SIDED|95.0|1.8|82.7||||||Differences in proportions between Group 1 (sovaprevir 200 mg plus ACH-3102 150/50 mg plus RBV) and overall placebo (placebo from Group 1 and Group 2 combined) along with corresponding 95% confidence intervals for risk difference calculated using exact unconditional methods were obtained.||82.7|1.8|
72523765|NCT01849562|144577287|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|70.0|||||TWO_SIDED|95.0|24.2|93.6||||||Differences in proportions between Group 2 (sovaprevir 400 mg plus ACH-3102 150/50 mg plus RBV) and overall placebo (placebo from Group 1 and Group 2 combined) along with corresponding 95% confidence intervals for risk difference calculated using exact unconditional methods were obtained.||93.6|24.2|
72523766|NCT02182999|144577298|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.596|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||A sample size of 17 patients in each group was previously calculated on the basis of a significance level of .05, a power of 80%, an anticipated pooled standard Deviation (SD) of 1.0 of the mean verbal NRS pain level, and a minimal clinically important difference in the mean verbal NRS pain level of 1.0 points between the groups. Anticipating a loss to follow-up, we planned to recruit a total of 50 patients (25 patients each group).||||0.596
72625118|NCT00835172|144779902|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Geometric Test/Ref Ratio x 100|101.0||||||90.0|96.8|105.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||105|96.8|
72625119|NCT00835172|144779903|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Geometric Test/Ref Ratio x 100|103.0||||||90.0|99.3|106.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||106|99.3|
72625120|NCT03274466|144779925|SUPERIORITY|Modified Intent-To-Treat|Odds Ratio (OR)|0.22||||0.0013|TWO_SIDED|95.0|0.08|0.59||Threshold for statistical significance: alpha = 0.048|Cochran-Mantel-Haenszel|||||0.59|0.08|0.0013
72625121|NCT03274466|144779926|SUPERIORITY|Modified Intent-To-Treat|Odds Ratio (OR)|0.33||||0.168|TWO_SIDED|95.0|0.07|1.7||Threshold for Statistical Significance: alpha = 0.048|Cochran-Mantel-Haenszel|||||1.70|0.07|0.1680
72406403|NCT02942017|144321622|SUPERIORITY||LS Mean Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.132||0.8262|TWO_SIDED|95.0|-0.29|0.23|||MMRM|||Insomnia-Late, Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.23|-0.29|0.8262
72523767|NCT02182999|144577299|SUPERIORITY||Mean Difference (Final Values)|0.4||||0.353|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.353
72523768|NCT01791465|144577333|SUPERIORITY_OR_OTHER|||||||0.08|||||||Wilcoxon (Mann-Whitney)|||||||0.08
72523769|NCT01791465|144577334|SUPERIORITY_OR_OTHER|||||||0.34||||||Unadjusted - this was a Wilcoxon signed rank p-value (Baseline vs. week 16) comparison|Wilcoxon (Mann-Whitney)|no adjustments||The null hypothesis was that there would be no difference between baseline and 16 week IL-6||||0.34
72523770|NCT01791465|144577335|SUPERIORITY_OR_OTHER|||||||0.046|||||||Wilcoxon (Mann-Whitney)|||||||0.046
72523771|NCT01791465|144577336|SUPERIORITY_OR_OTHER|||||||0.92|||||||Wilcoxon (Mann-Whitney)|||||||0.92
72523772|NCT01791465|144577337|SUPERIORITY_OR_OTHER|||||||0.69|||||||Wilcoxon (Mann-Whitney)|||||||0.69
72523773|NCT01791465|144577338|SUPERIORITY_OR_OTHER|||||||0.47|||||||Wilcoxon (Mann-Whitney)|||||||0.47
72523774|NCT01791465|144577339|SUPERIORITY_OR_OTHER|||||||0.92|||||||Wilcoxon (Mann-Whitney)|||||||0.92
72523775|NCT01791465|144577340|SUPERIORITY_OR_OTHER|||||||0.03|||||||Wilcoxon (Mann-Whitney)|||||||0.03
72523776|NCT01791465|144577341|SUPERIORITY_OR_OTHER|||||||0.6|||||||Wilcoxon (Mann-Whitney)|||||||0.60
72523777|NCT01791465|144577342|SUPERIORITY_OR_OTHER|||||||0.08|||||||Wilcoxon (Mann-Whitney)|||||||0.08
72523778|NCT01791465|144577343|SUPERIORITY_OR_OTHER|||||||0.08|||||||Wilcoxon (Mann-Whitney)|||||||0.08
72523779|NCT01791465|144577344|SUPERIORITY_OR_OTHER|||||||0.07|||||||Wilcoxon (Mann-Whitney)|||||||0.07
72523780|NCT01791465|144577345|SUPERIORITY_OR_OTHER|||||||0.69|||||||Wilcoxon (Mann-Whitney)|||||||0.69
72523781|NCT01791465|144577346|SUPERIORITY_OR_OTHER|||||||0.5|||||||Wilcoxon (Mann-Whitney)|||||||0.50
72625122|NCT03274466|144779927|SUPERIORITY|Modified Intent-To-Treat|Odds Ratio (OR)|0.34||||0.3386|TWO_SIDED|95.0|0.04|3.39||Threshold for Statistical Significance: alpha = 0.048|Cochran-Mantel-Haenszel|||||3.39|0.04|0.3386
72523782|NCT01791465|144577347|SUPERIORITY_OR_OTHER|||||||0.42|||||||Wilcoxon (Mann-Whitney)|||||||0.42
72523783|NCT01791465|144577348|SUPERIORITY_OR_OTHER|||||||0.89|||||||Wilcoxon (Mann-Whitney)|||||||0.89
72523784|NCT01791465|144577349|SUPERIORITY_OR_OTHER|||||||0.75|||||||Wilcoxon (Mann-Whitney)|||||||0.75
72523785|NCT01791465|144577350|SUPERIORITY_OR_OTHER|||||||0.046|||||||Wilcoxon (Mann-Whitney)|||||||0.046
72523786|NCT01791465|144577351|SUPERIORITY_OR_OTHER|||||||0.25|||||||Wilcoxon (Mann-Whitney)|||||||0.25
72523787|NCT01791465|144577352|SUPERIORITY_OR_OTHER|||||||0.12|||||||Wilcoxon (Mann-Whitney)|||||||0.12
72523788|NCT01791465|144577353|SUPERIORITY_OR_OTHER|||||||0.046|||||||Wilcoxon (Mann-Whitney)|||||||0.046
72523789|NCT02809846|144577407|OTHER|Bivariate associations between variables were assessed using statistical methods appropriate for the variable types. Baseline characteristics (demographics, other morbidities, baseline medication use, pain intensity and QOL) were compared between the two treatment groups to assess effectiveness of randomization and identify important covariates for multivariable analyses. Associations between demographic variables and primary and secondary endpoints were examined.|||||<|0.05||||||Sensitivity analyses comparing use of data from all participants with use of participants with complete data only was also performed. Agreement between different measures representing the same variable type was assessed using correlation analyses.|Mixed Models Analysis|Multivariable analysis with mixed effect regression models were used to assess the effect of treatment group on the primary and secondary outcomes.||Initially, a sample size of 20 participants per treatment group (active and sham) was selected to achieve 90% power to find a 20% difference in mean percent change in opioid consumption between the two groups with an estimated standard deviation of 22% and 80% power to detect the same difference with a standard deviation of 19% at a two-sided alpha = 0.05|Similar models were used to assess associations of treatment group with secondary endpoints. Model fit was assessed by Akaike's Information Criteria to determine optimal covariance structure.|||<0.05
72523790|NCT01512693|144577408|NON_INFERIORITY_OR_EQUIVALENCE|Similarity will be concluded if the GMR (moderate hepatic insufficiency / healthy) is contained within the interval \[0.40, 2.50\].|GMR|0.85|||||TWO_SIDED|90.0|0.61|1.19||||||Natural log-transformed plasma values were analyzed using an analysis of covariance (ANCOVA) model with a categorical factor for population (moderate hepatic insufficiency participants, healthy matched control participants) and continuous covariates for age and body mass index (BMI). Data are back transformed to geometric least-squares mean ratio (GMR) (moderate hepatic insufficiency / healthy) and 90% confidence intervals.||1.19|0.61|
72625123|NCT03274466|144779928|SUPERIORITY||Odds Ratio (OR)|0.22||||0.0013|TWO_SIDED|95.0|0.08|0.59||Threshold for statistical significance: alpha = 0.048|Cochran-Mantel-Haenszel|||Sensitivity analysis of the Primary Endpoint using the Intent-To-Treat population.||0.59|0.08|0.0013
72625124|NCT02445911|144779940|OTHER||Least-squares Mean Difference|-6.78|||||TWO_SIDED|95.0|-23.75|10.18|||||Least-squares means have baseline and site as covariates. Placebo was the reference group.|||10.18|-23.75|
72625125|NCT02445911|144779940|OTHER||Least-squares Mean Difference|-2.97|||||TWO_SIDED|95.0|-19.65|13.72|||||Least-squares means have baseline and site as covariates. Placebo was the reference group.|||13.72|-19.65|
72625126|NCT02445911|144779940|OTHER||Least-squares Mean Difference|-5.05|||||TWO_SIDED|95.0|-21.97|11.88|||||Least-squares means have baseline and site as covariates. Placebo was the reference group.|||11.88|-21.97|
72625127|NCT01649869|144779958|SUPERIORITY|||||||0.0859|||||||Generalized linear model|Generalized linear model for binary outcome based on generalized estimating equations.||||||0.0859
72625128|NCT01649869|144779959|SUPERIORITY|||||||0.7068|||||||Fisher Exact|||||||0.7068
72625129|NCT01649869|144779960|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1
72625130|NCT01649869|144779961|SUPERIORITY|||||||0.7068|||||||Fisher Exact|||||||0.7068
72625131|NCT01649869|144779962|SUPERIORITY|||||||0.0752|||||||Fisher Exact|||||||0.0752
72625132|NCT01649869|144779964|SUPERIORITY|||||||0.4823|||||||Generalized linear model|Generalized linear model for binary outcome using generalized estimating equations.||||||0.4823
72625133|NCT01649869|144779965|SUPERIORITY|||||||0.0859|||||||Generalized linear model|Generalized linear model for binary outcome using generalized estimating equations.||||||0.0859
72625134|NCT01649869|144779966|OTHER|Association of binary outcome and continuous outcome||||||0.8212|||||||Generalized linear model|For binary outcome using generalized estimating equations||||||0.8212
72625135|NCT01649869|144779967|OTHER|Association of binary outcome and continuous outcome and continuous outcome||||||0.8356|||||||Generalized linear model|Generalized linear model for binary outcome using generalized estimating equations.||||||0.8356
72625136|NCT01649869|144779968|OTHER|Association of binary outcome and continuous outcome||||||0.7961|||||||Generalized linear model|Generalized linear model for binary outcome using generalized estimating equations||||||0.7961
72625137|NCT01649869|144779969|OTHER|Association of binary outcome and continuous outcome||||||0.8675|||||||Generalized linear model|Generalized linear model for binary outcome||||||0.8675
72406404|NCT02942017|144321622|SUPERIORITY||LS Mean Difference|-0.25|STANDARD_ERROR_OF_MEAN|0.141||0.0749|TWO_SIDED|95.0|-0.54|0.03|||MMRM|||Insomnia-Late, Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.03|-0.54|0.0749
72523791|NCT01512693|144577409|SUPERIORITY_OR_OTHER||GMR|0.71|||||TWO_SIDED|90.0|0.51|1.0||||||Natural log-transformed plasma values were analyzed using an ANCOVA model with a categorical factor for population (moderate hepatic insufficiency participants, healthy matched control participants) and continuous covariates for age and BMI. Data are back transformed to GMR (moderate hepatic insufficiency / healthy) and 90% confidence intervals.||1.00|0.51|
72523792|NCT02820038|144577449|SUPERIORITY||Odds Ratio (OR)|1.08||||0.8408|TWO_SIDED|95.0|0.52|2.24|||Regression, Logistic|Regression model adjusted for whether participant met criteria for informed decision making at baseline.|Modeled probability of meeting criteria for informed decision making at the 6-month follow-up. Independent variable coded: 0=Other Consumer Medication Information (CMI) Only, Other CMI+SMART, DrugFactsBox® (DFB) Only; 1=DFB+SMART|The investigators hypothesized that participants would be more likely to meet the criteria for Informed Decision-Making at the 6-month follow-up if they were assigned to receive medication information via the DrugFactsBox® format combined with gist reasoning training, delivered via the SMART Program, compared to individuals in the other three groups.||2.24|0.52|0.8408
72523793|NCT02820038|144577449|SUPERIORITY||Odds Ratio (OR)|1.18||||0.58|TWO_SIDED|95.0|0.66|2.12|||Regression, Logistic|Regression model adjusted for whether participant met criteria for informed decision making at baseline.|Modeled probability of meeting criteria for informed decision making at the 6-month follow-up. Independent variable coded: 0=Other CMI Only or Other CMI+SMART, 1=DFB or DFB + SMART|The investigators hypothesized that participants would be more likely to meet the criteria for Informed Decision-Making at the 6-month follow-up if they were assigned to receive written medication information via the DrugFactsBox® format compared to the Other CMI format.||2.12|0.66|0.58
72625138|NCT01649869|144779970|OTHER|Association of binary outcome and continuous outcome||||||0.9682|||||||Generalized linear model|Generalized linear model for binary outcome||||||0.9682
72625139|NCT01649869|144779971|OTHER|Association of binary outcome and continuous outcome||||||0.6063|||||||Generalized linear model|Generalized linear model for binary outcome||||||0.6063
72625140|NCT01649869|144779972|SUPERIORITY|||||||0.0001|||||||Fisher Exact|||||||0.0001
72625141|NCT01649869|144779973|SUPERIORITY|||||||0.6043|||||||Fisher Exact|||||||0.6043
72625142|NCT01649869|144779974|SUPERIORITY|||||||0.6513|||||||Fisher Exact|||||||0.6513
72625143|NCT01649869|144779975|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.0
72625144|NCT01649869|144779976|SUPERIORITY|||||||0.0659|||||||Fisher Exact|||||||0.0659
72625145|NCT01649869|144779977|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.0
72625146|NCT01168596|144780026|SUPERIORITY_OR_OTHER||Slope|1.3|STANDARD_ERROR_OF_MEAN|5.26||0.81|TWO_SIDED|95.0|-9.13|11.73|||Regression, Linear|||||11.73|-9.13|0.81
72625147|NCT01168596|144780027|SUPERIORITY_OR_OTHER||Slope|4.38|STANDARD_ERROR_OF_MEAN|3.6||0.23|TWO_SIDED|95.0|-2.75|11.51|||Regression, Linear|||||11.51|-2.75|0.23
72625148|NCT01168596|144780028|SUPERIORITY_OR_OTHER||Slope|1.61|STANDARD_ERROR_OF_MEAN|5.03||0.75|TWO_SIDED|95.0|-8.37|11.59|||Regression, Linear|||||11.59|-8.37|0.75
72625149|NCT01168596|144780029|SUPERIORITY_OR_OTHER||Slope|1.88|STANDARD_ERROR_OF_MEAN|3.06||0.54|TWO_SIDED|95.0|-4.18|7.94|||Regression, Linear|||||7.94|-4.18|0.54
72625150|NCT01168596|144780030|SUPERIORITY_OR_OTHER||Slope|-5.17|STANDARD_ERROR_OF_MEAN|6.36||0.42|TWO_SIDED|95.0|-17.76|7.43|||Regression, Linear|||||7.43|-17.76|0.42
72625151|NCT01168596|144780031|SUPERIORITY_OR_OTHER||Slope|0.36|STANDARD_ERROR_OF_MEAN|0.47||0.44|TWO_SIDED|95.0|-0.56|1.29|||Regression, Linear|||||1.29|-0.56|0.44
72625152|NCT01168596|144780032|SUPERIORITY_OR_OTHER||Slope|2.27|STANDARD_ERROR_OF_MEAN|10.02||0.82|TWO_SIDED|95.0|-17.59|22.13|||Regression, Linear|||||22.13|-17.59|0.82
72625153|NCT01168596|144780033|SUPERIORITY_OR_OTHER||Slope|-4.73|STANDARD_ERROR_OF_MEAN|7.36||0.52|TWO_SIDED|95.0|-19.31|9.85|||Regression, Linear|||||9.85|-19.31|0.52
72625154|NCT01168596|144780034|SUPERIORITY_OR_OTHER||Slope|0.11|STANDARD_ERROR_OF_MEAN|1.14||0.93|TWO_SIDED|95.0|-2.15|2.36|||Regression, Linear|||||2.36|-2.15|0.93
72625155|NCT01168596|144780035|SUPERIORITY_OR_OTHER||Slope|-0.11|STANDARD_ERROR_OF_MEAN|0.47||0.82|TWO_SIDED|95.0|-1.05|0.83|||Regression, Linear|||||0.83|-1.05|0.82
72523794|NCT02820038|144577449|SUPERIORITY||Odds Ratio (OR)|1.48||||0.1937|TWO_SIDED|95.0|0.82|2.68|||Regression, Logistic|Regression model adjusted for whether participant met criteria for informed decision making at baseline.|Modeled probability of meeting criteria for informed decision making at the 6-month follow-up. Independent variable coded: 0=Other CMI Only or DFB Only, 1=Other CMI + SMART or DFB+SMART.|The investigators hypothesized that participants would be more likely to meet the criteria for Informed Decision-Making at the 6-month follow-up if they were assigned to receive gist reasoning training, delivered via the SMART Program, compared to those who were not assigned to receive this training.||2.68|0.82|0.1937
72523795|NCT02820038|144577449|SUPERIORITY||Odds Ratio (OR)|2.379||||0.0193|TWO_SIDED|95.0|1.15|4.92|||Regression, Logistic|Sample restricted to participants who did not meet the criteria for informed decision making at baseline.|Modeled probability of meeting criteria for informed decision making at the 6-month follow-up. Independent variable coded: 0=Other CMI Only or DFB Only, 1=Other CMI + SMART or DFB+SMART.|In this analysis, participants were restricted to those who did not meet criteria for informed decision-making at baseline.||4.92|1.15|0.0193
72523796|NCT02820038|144577449|SUPERIORITY||Odds Ratio (OR)|0.53||||0.2216|TWO_SIDED|95.0|0.19|1.48|||Regression, Logistic||Modeled probability of meeting criteria for informed decision making at the 6-month follow-up. Independent variable coded: 0=Other CMI Only or DFB Only, 1=Other CMI + SMART or DFB+SMART.|In this analysis, participants were restricted to those who met the criteria for informed decision-making at baseline.||1.48|0.19|0.2216
72523797|NCT02820038|144577450|SUPERIORITY|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|-1.83|STANDARD_ERROR_OF_MEAN|1.32||0.163|TWO_SIDED|95.0|-1.83|0.75|||Regression, Linear||Independent variable coded: 0=Other CMI Only, Other CMI+SMART, DFB Only; 1=DFB+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit a greater increase in knowledge between baseline and the 6-month follow-up if they were assigned to receive medication information via the DrugFactsBox® format combined with gist reasoning training, delivered via the SMART Program, compared to individuals in the other three groups.||0.75|-1.83|0.1630
72523798|NCT02820038|144577450|SUPERIORITY|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|-0.28|STANDARD_ERROR_OF_MEAN|1.05||0.7892|TWO_SIDED|95.0|-2.33|1.77|||Regression, Linear|||The investigators hypothesized that participants would exhibit a greater increase in knowledge between baseline and the 6-month follow-up if they were assigned to receive written medication information via the DrugFactsBox® format compared to the Other CMI format.|Independent variable coded: 0=Other CMI Only, DFB Only; 1=DFB+SMART, Other CMI+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|1.77|-2.33|0.7892
72523799|NCT02820038|144577450|SUPERIORITY|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|-2.19|STANDARD_ERROR_OF_MEAN|1.05||0.0377|TWO_SIDED|95.0|-4.25|-0.13|||Regression, Linear||Independent variable coded: 0=Other CMI Only, DFB Only; 1=DFB+SMART, Other CMI+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit a greater increase in knowledge between baseline and the 6-month follow-up if they were assigned to receive gist reasoning training, delivered via the SMART Program, compared to those who were not assigned to receive this training.||-0.13|-4.25|0.0377
72625156|NCT01168596|144780036|SUPERIORITY_OR_OTHER||Slope|-4.53|STANDARD_ERROR_OF_MEAN|7.68||0.56|TWO_SIDED|95.0|-19.74|10.69|||Regression, Linear|||||10.69|-19.74|0.56
72625157|NCT01168596|144780037|SUPERIORITY_OR_OTHER||Slope|-2.21|STANDARD_ERROR_OF_MEAN|2.93||0.45|TWO_SIDED|95.0|-8.02|3.59|||Regression, Linear|||||3.59|-8.02|0.45
72625158|NCT01168596|144780038|SUPERIORITY_OR_OTHER||Slope|2.76|STANDARD_ERROR_OF_MEAN|4.94||0.58|TWO_SIDED|95.0|-7.02|12.55|||Regression, Linear|||||12.55|-7.02|0.58
72523800|NCT02820038|144577451|SUPERIORITY|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|0.05|STANDARD_ERROR_OF_MEAN|0.53||0.9216|TWO_SIDED|95.0|-0.98|1.08|||Regression, Linear|||The investigators hypothesized that participants would exhibit a greater increase in values favorable to aggressive therapy between baseline and the 6-month follow-up if they were assigned to receive medication information via the DrugFactsBox® format combined with gist reasoning training, delivered via the SMART Program, compared to individuals in the other three groups.|Independent variable coded: 0=Other CMI Only, Other CMI+SMART, DFB Only; 1=DFB+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|1.08|-0.98|0.9216
72523801|NCT02820038|144577451|SUPERIORITY|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|0.36|STANDARD_ERROR_OF_MEAN|0.42||0.3843|TWO_SIDED|95.0|-0.45|1.17|||Regression, Linear||Independent variable coded: 0=Other CMI Only, Other CMI+SMART; 1=DFB Only, DFB+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit a greater increase in values favoring aggressive therapy between baseline and the 6-month follow-up if they were assigned to receive written medication information via the DrugFactsBox® format compared to the Other CMI format.||1.17|-0.45|0.3843
72523802|NCT02820038|144577451|SUPERIORITY|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|0.27|STANDARD_ERROR_OF_MEAN|0.42||0.509|TWO_SIDED|95.0|-0.54|1.09|||Regression, Linear||Independent variable coded: 0=Other CMI Only, DFB Only; 1=DFB+SMART, Other CMI+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit a greater increase in values favoring aggressive therapy between baseline and the 6-month follow-up if they were assigned to receive gist reasoning training, delivered via the SMART Program, compared to those who were not assigned to receive this training.||1.09|-0.54|0.5090
72542533|NCT01010230|144614897|NON_INFERIORITY_OR_EQUIVALENCE|The power calculation was based on the primary aim and is provided above.|Mean Difference (Final Values)|0.13||||0.17|TWO_SIDED|95.0|0.0|0.26||The threshold for significance was established a priori at alpha=0.05.|t-test, 2 sided|||Active and placebo group means were compared with a 2-sample t-test after log-transforming the variable.||0.26|0.00|0.17
72625159|NCT01168596|144780039|SUPERIORITY_OR_OTHER||Slope|0.04|STANDARD_ERROR_OF_MEAN|0.54||0.95|TWO_SIDED|95.0|-1.04|1.11|||Regression, Linear|||||1.11|-1.04|0.95
72523803|NCT02820038|144577452|SUPERIORITY|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|-0.33|STANDARD_ERROR_OF_MEAN|0.23||0.1486|TWO_SIDED|95.0|-0.77|0.12|||Regression, Linear||Independent variable coded: 0=Other CMI Only, Other CMI+SMART, DFB Only; 1=DFB+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit greater increases in gist reasoning ability at the 6-month follow-up if they were assigned to receive medication information via the DrugFactsBox® format combined with gist reasoning training, delivered via the SMART Program, compared to individuals in the other three groups.||0.12|-0.77|0.1486
72523804|NCT02820038|144577452|SUPERIORITY|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|-0.12|STANDARD_ERROR_OF_MEAN|0.18||0.4888|TWO_SIDED|95.0|-0.47|0.22|||Regression, Linear||Independent variable coded: 0=Other CMI Only, Other CMI+SMART; 1=DFB Only, DFB+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit a greater increase in gist reasoning ability between baseline and the 6-month follow-up if they were assigned to receive written medication information via the DrugFactsBox® format compared to the Other CMI format.||0.22|-0.47|0.4888
72523805|NCT02820038|144577452|SUPERIORITY|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|0.03|STANDARD_ERROR_OF_MEAN|0.18||0.8637|TWO_SIDED|95.0|-0.32|0.38|||Regression, Linear||Independent variable coded: 0=Other CMI Only, DFB Only; 1=DFB+SMART, Other CMI+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit a greater increase in gist reasoning ability between baseline and the 6-month follow-up if they were assigned to receive gist reasoning training, delivered via the SMART Program, compared to those who were not assigned to receive this training.||0.38|-0.32|0.8637
72523806|NCT02820038|144577453|SUPERIORITY|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|0.17|STANDARD_ERROR_OF_MEAN|0.25||0.507|TWO_SIDED|95.0|-0.33|0.66|||Regression, Linear||Independent variable coded: 0=Other CMI Only, Other CMI+SMART, DFB Only; 1=DFB+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit greater gist reasoning ability at the 6-month follow-up if they were assigned to receive medication information via the DrugFactsBox® format combined with gist reasoning training, delivered via the SMART Program, compared to individuals in the other three groups.||0.66|-0.33|0.5070
72523807|NCT02820038|144577453|SUPERIORITY|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|0.14|STANDARD_ERROR_OF_MEAN|0.19||0.4821|TWO_SIDED|95.0|-0.25|0.52|||Regression, Linear||Independent variable coded: 0=Other CMI Only, Other CMI+SMART; 1=DFB Only, DFB+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit a greater increase in gist reasoning ability between baseline and the 6-month follow-up if they were assigned to receive written medication information via the DrugFactsBox® format compared to the Other CMI format.||0.52|-0.25|0.4821
72523808|NCT02820038|144577453|SUPERIORITY|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|0.06|STANDARD_ERROR_OF_MEAN|0.2||0.7777|TWO_SIDED|95.0|-0.33|0.44|||Regression, Linear||Independent variable coded: 0=Other CMI Only, DFB Only; 1=DFB+SMART, Other CMI+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit a greater increase in gist reasoning ability between baseline and the 6-month follow-up if they were assigned to receive gist reasoning training, delivered via the SMART Program, compared to those who were not assigned to receive this training.||0.44|-0.33|0.7777
72523809|NCT02820038|144577454|SUPERIORITY|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|0.33|STANDARD_ERROR_OF_MEAN|0.64||0.6084|TWO_SIDED|95.0|-0.93|1.58|||Regression, Linear||Independent variable coded: 0=Other CMI Only, Other CMI+SMART, DFB Only; 1=DFB+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit greater increases in satisfaction at the 6-month follow-up if they were assigned to receive medication information via the DrugFactsBox® format combined with gist reasoning training, delivered via the SMART Program, compared to individuals in the other three groups.||1.58|-0.93|0.6084
72523810|NCT02820038|144577454|SUPERIORITY|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|0.26|STANDARD_ERROR_OF_MEAN|0.5||0.597|TWO_SIDED|95.0|-0.71|1.23|||Regression, Linear||Independent variable coded: 0=Other CMI Only, Other CMI+SMART; 1=DFB Only, DFB+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit a greater increase in satisfaction between baseline and the 6-month follow-up if they were assigned to receive written medication information via the DrugFactsBox® format compared to the Other CMI format.||1.23|-0.71|0.5970
72570770|NCT02504671|144670143|OTHER||Mean Difference (Net)|0.0|||>|0.999|TWO_SIDED|95.0|-4.23|4.23||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, Social Functioning|||4.23|-4.23|>0.999
72570771|NCT02504671|144670143|OTHER||Mean Difference (Net)|0.28||||0.896|TWO_SIDED|95.0|-3.91|4.46||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, Social Functioning|||4.46|-3.91|0.896
72570772|NCT02504671|144670143|OTHER||Mean Difference (Net)|-2.89||||0.424|TWO_SIDED|95.0|-10.02|4.24||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, Social Functioning|||4.24|-10.02|0.424
72625160|NCT01168596|144780040|SUPERIORITY_OR_OTHER||Slope|-0.38|STANDARD_ERROR_OF_MEAN|0.54||0.48|TWO_SIDED|95.0|-1.45|0.69|||Regression, Linear|||||0.69|-1.45|0.48
72570773|NCT02504671|144670143|OTHER||Mean Difference (Net)|-0.44||||0.898|TWO_SIDED|95.0|-7.16|6.29||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, Social Functioning|||6.29|-7.16|0.898
72406405|NCT02942017|144321622|SUPERIORITY||LS Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.135||0.1923|TWO_SIDED|95.0|-0.45|0.09|||MMRM|||Insomnia-Late, Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.09|-0.45|0.1923
72570774|NCT02504671|144670143|OTHER||Mean Difference (Net)|-3.79||||0.26|TWO_SIDED|95.0|-10.42|2.84||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, Social Functioning|||2.84|-10.42|0.260
72406406|NCT02942017|144321622|SUPERIORITY||LS Mean Difference|-0.38|STANDARD_ERROR_OF_MEAN|0.176||0.0326|TWO_SIDED|95.0|-0.73|-0.03|||MMRM|||Insomnia-Late, Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.03|-0.73|0.0326
72406407|NCT02942017|144321622|SUPERIORITY||LS Mean Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.171||0.444|TWO_SIDED|95.0|-0.47|0.21|||MMRM|||Insomnia-Late, Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.21|-0.47|0.4440
72406408|NCT02942017|144321622|SUPERIORITY||LS Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.134||0.7057|TWO_SIDED|95.0|-0.32|0.22|||MMRM|||Insomnia-Late, Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.22|-0.32|0.7057
72406409|NCT02942017|144321622|SUPERIORITY||LS Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.137||0.2865|TWO_SIDED|95.0|-0.42|0.13|||MMRM|||Work and Activities, Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.13|-0.42|0.2865
72523811|NCT02820038|144577454|SUPERIORITY|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|0.33|STANDARD_ERROR_OF_MEAN|0.5||0.5094|TWO_SIDED|95.0|-0.65|1.31|||Regression, Linear||Independent variable coded: 0=Other CMI Only, DFB Only; 1=DFB+SMART, Other CMI+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit a greater increase in satisfaction between baseline and the 6-month follow-up if they were assigned to receive gist reasoning training, delivered via the SMART Program, compared to those who were not assigned to receive this training.||1.31|-0.65|.5094
72523812|NCT02820038|144577455|SUPERIORITY|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|-1.48|STANDARD_ERROR_OF_MEAN|2.74||0.5866|TWO_SIDED|95.0|-6.85|3.89|||Regression, Linear||Independent variable coded: 0=Other CMI Only, Other CMI+SMART, DFB Only; 1=DFB+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit greater increases in satisfaction at the 6-month follow-up if they were assigned to receive medication information via the DrugFactsBox® format combined with gist reasoning training, delivered via the SMART Program, compared to individuals in the other three groups.||3.89|-6.85|0.5866
72570775|NCT02504671|144670143|OTHER||Mean Difference (Net)|1.02||||0.603|TWO_SIDED|95.0|-2.85|4.9||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, Vitality|||4.90|-2.85|0.603
72406410|NCT02942017|144321622|SUPERIORITY||LS Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.17||0.9475|TWO_SIDED|95.0|-0.33|0.35|||MMRM|||Work and Activities, Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.35|-0.33|0.9475
72523813|NCT02820038|144577455|SUPERIORITY|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|0.35|STANDARD_ERROR_OF_MEAN|2.13||0.8689|TWO_SIDED|95.0|-3.82|4.52|||Regression, Linear||Independent variable coded: 0=Other CMI Only, Other CMI+SMART; 1=DFB Only, DFB+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit a greater increase in satisfaction between baseline and the 6-month follow-up if they were assigned to receive written medication information via the DrugFactsBox® format compared to the Other CMI format.||4.52|-3.82|0.8689
72570776|NCT02504671|144670143|OTHER||Mean Difference (Net)|3.56||||0.068|TWO_SIDED|95.0|-0.26|7.39||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, Vitality|||7.39|-0.26|0.068
72570777|NCT02504671|144670143|OTHER||Mean Difference (Net)|2.63||||0.174|TWO_SIDED|95.0|-1.17|6.43||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, Vitality|||6.43|-1.17|0.174
72570778|NCT02504671|144670143|OTHER||Mean Difference (Net)|1.97||||0.334|TWO_SIDED|95.0|-2.04|5.98||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, Vitality|||5.98|-2.04|0.334
72570779|NCT02504671|144670143|OTHER||Mean Difference (Net)|2.91||||0.153|TWO_SIDED|95.0|-1.09|6.91||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, Vitality|||6.91|-1.09|0.153
72523814|NCT02820038|144577455|SUPERIORITY|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|1.66|STANDARD_ERROR_OF_MEAN|2.14||0.4356|TWO_SIDED|95.0|-2.53|5.86|||Regression, Linear||Independent variable coded: 0=Other CMI Only, DFB Only; 1=DFB+SMART, Other CMI+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit a greater increase in satisfaction between baseline and the 6-month follow-up if they were assigned to receive gist reasoning training, delivered via the SMART Program, compared to those who were not assigned to receive this training.||5.86|-2.53|.4356
72523815|NCT02820038|144577456|SUPERIORITY|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|3.48|STANDARD_ERROR_OF_MEAN|2.95||0.2366|TWO_SIDED|95.0|-2.3|9.26|||Regression, Linear|||The investigators hypothesized that participants would exhibit greater increases in self-efficacy at the 6-month follow-up if they were assigned to receive medication information via the DrugFactsBox® format combined with gist reasoning training, delivered via the SMART Program, compared to individuals in the other three groups.||9.26|-2.30|0.2366
72523816|NCT02820038|144577456|SUPERIORITY|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|0.33|STANDARD_ERROR_OF_MEAN|2.29||0.8841|TWO_SIDED|95.0|-4.16|4.83|||Regression, Linear||Independent variable coded: 0=Other CMI Only, DFB Only; 1=DFB+SMART, Other CMI+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit a greater increase in self-efficacy between baseline and the 6-month follow-up if they were assigned to receive written medication information via the DrugFactsBox® format compared to the Other CMI format.||4.83|-4.16|0.8841
72625161|NCT01168596|144780041|SUPERIORITY_OR_OTHER||Slope|-0.07|STANDARD_ERROR_OF_MEAN|0.33||0.84|TWO_SIDED|95.0|-0.71|0.58|||Regression, Linear|||||0.58|-0.71|0.84
72625162|NCT01168596|144780042|SUPERIORITY_OR_OTHER||Slope|0.49|STANDARD_ERROR_OF_MEAN|0.64||0.44|TWO_SIDED|95.0|-0.77|1.76|||Regression, Linear|||||1.76|-0.77|0.44
72625163|NCT01168596|144780043|SUPERIORITY_OR_OTHER||Slope|-0.33|STANDARD_ERROR_OF_MEAN|0.88||0.71|TWO_SIDED|95.0|-2.06|1.41|||Regression, Linear|||||1.41|-2.06|0.71
72625164|NCT01168596|144780044|SUPERIORITY_OR_OTHER||Slope|0.64|STANDARD_ERROR_OF_MEAN|0.64||0.31|TWO_SIDED|95.0|-0.62|1.9|||Regression, Linear|||||1.90|-0.62|0.31
72523817|NCT02820038|144577456|SUPERIORITY|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|1.45|STANDARD_ERROR_OF_MEAN|2.3||0.5264|TWO_SIDED|95.0|-3.05|5.95|||Regression, Linear||Independent variable coded: 0=Other CMI Only, DFB Only; 1=DFB+SMART, Other CMI+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit a greater increase in self-efficacy between baseline and the 6-month follow-up if they were assigned to receive gist reasoning training, delivered via the SMART Program, compared to those who were not assigned to receive this training.||5.95|-3.05|0.5264
72542534|NCT01010230|144614898|NON_INFERIORITY_OR_EQUIVALENCE|The power calculation was based on the primary aim and is provided above.|Mean Difference (Final Values)|0.08||||0.38|TWO_SIDED|95.0|-0.04|0.2||The threshold for significance was established a priori at alpha=0.05.|t-test, 2 sided|||Active and placebo group means were compared with a 2-sample t-test after log-transforming the variable.||0.20|-0.04|0.38
72542535|NCT01010230|144614899|NON_INFERIORITY_OR_EQUIVALENCE|The power calculation was based on the primary aim and is provided above.|Mean Difference (Final Values)|-0.02||||0.88|TWO_SIDED|95.0|-0.22|0.18||The threshold for significance was established a priori at alpha=0.05.|t-test, 2 sided|||Active and placebo group means were compared with a 2-sample t-test after log-transforming the variable.||0.18|-0.22|0.88
72542536|NCT01010230|144614900|NON_INFERIORITY_OR_EQUIVALENCE|The power calculation was based on the primary aim and is provided above.|Mean Difference (Final Values)|0.28||||0.06|TWO_SIDED|95.0|0.09|0.46||The threshold for significance was established a priori at alpha=0.05.|t-test, 2 sided|||Active and placebo group means were compared with a 2-sample t-test after log-transforming the variable.||0.46|0.09|0.06
72542537|NCT00530439|144614907|SUPERIORITY_OR_OTHER|||||||0.014||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.014
72542538|NCT03705169|144614911|EQUIVALENCE|Confidence Interval (CI) on Geometric Mean Ratio.|Geometric Mean Ratio|3.2|||||TWO_SIDED|95.0|1.9|5.3|||||The ratios of the geometric means (Arm A/Arm C) and the corresponding 95% CI were obtained by exponentiating the least squares mean difference and its 95% CI of the natural log-transformed data.|As dose-normalized AUC 0-12WK values were considered, participants were pooled within Arm (i.e., Arm A participants receiving 1, 3, 10, or 30 mg/kg were pooled and Arm C participants 0.3 or 1.0 mg/kg were pooled).|No comparisons were done with Arm B participants, as only two participants in that arm had available measurements such that AUC 0-12WK could be estimated.|5.3|1.9|
72542539|NCT03705169|144614912|OTHER||Mean|-0.18||||0.26|TWO_SIDED|95.0|-0.53|0.18||Under the null hypothesis, it was assumed there was no change in HIV-1 RNA (log10 copies/mL) from baseline to Day 7 of SAR441236 monotherapy for viremic participants with HIV (Arm B cohorts).|t-test, 2 sided|||Arm B participants were pooled across doses for analysis.||0.18|-0.53|0.26
72542540|NCT03705169|144614914|OTHER||Mean|-0.02||||0.78|TWO_SIDED|95.0|-0.24|0.19||Under the null hypothesis, it was assumed there was no change in HIV-1 RNA (log10 copies/mL) from baseline to Day 14 of SAR441236 monotherapy for viremic participants with HIV (Arm B cohorts).|t-test, 2 sided|||Arm B participants were pooled across doses for analysis.||0.19|-0.24|0.78
72625165|NCT01168596|144780045|SUPERIORITY_OR_OTHER||Slope|-0.06|STANDARD_ERROR_OF_MEAN|0.82||0.94|TWO_SIDED|95.0|-1.68|1.56|||Regression, Linear|||||1.56|-1.68|0.94
72625166|NCT00123630|144780061|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.05
72542541|NCT01963676|144614931|SUPERIORITY_OR_OTHER|||||||0.48|TWO_SIDED|||||There was no adjustment because we just performed one comparison|t-test, 2 sided|Difference from Day 5 to Baseline was compared between the sham and the tDCS group using an unpaired t-test. Degrees of freedom: df = 24||"The null hypothesis was that there is no difference between the changes in the AHRS score from baseline to 5 days between the groups:~H0: μ1 = μ2 μ1: mean(difference 5 days-baseline) for tDCS group (n=13) μ2: mean(difference 5 days-baseline) for sham group (n=13)"||||0.48
72406411|NCT02942017|144321622|SUPERIORITY||LS Mean Difference|-0.25|STANDARD_ERROR_OF_MEAN|0.185||0.188|TWO_SIDED|95.0|-0.61|0.12|||MMRM|||Work and Activities, Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.12|-0.61|0.1880
72523818|NCT02820038|144577457|SUPERIORITY|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|-0.1|STANDARD_ERROR_OF_MEAN|2.19||0.9604|TWO_SIDED|95.0|-4.4|4.18|||Regression, Linear||Independent variable coded: 0=Other CMI Only, Other CMI+SMART, DFB Only; 1=DFB+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit greater increases in medication adherence at the 6-month follow-up if they were assigned to receive medication information via the DrugFactsBox® format combined with gist reasoning training, delivered via the SMART Program, compared to individuals in the other three groups.||4.18|-4.40|0.9604
72523819|NCT02820038|144577457|SUPERIORITY|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|-3.62|STANDARD_ERROR_OF_MEAN|1.64||0.0279|TWO_SIDED|95.0|-6.84|-0.4|||Regression, Linear||Independent variable coded: 0=Other CMI Only, Other CMI+SMART; 1=DFB Only, DFB+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit a greater increase in adherence between baseline and the 6-month follow-up if they were assigned to receive written medication information via the DrugFactsBox® format compared to the Other CMI format.||-0.40|-6.84|0.0279
72523820|NCT02820038|144577457|SUPERIORITY|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|3.92|STANDARD_ERROR_OF_MEAN|1.66||0.0184|TWO_SIDED|95.0|0.67|7.18|||Regression, Linear||Independent variable coded: 0=Other CMI Only, DFB Only; 1=DFB+SMART, Other CMI+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit a greater increase in medication adherence between baseline and the 6-month follow-up if they were assigned to receive gist reasoning training, delivered via the SMART Program, compared to those who were not assigned to receive this training.||7.18|0.67|0.0184
72523821|NCT02820038|144577458|SUPERIORITY|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|2.79|STANDARD_ERROR_OF_MEAN|2.73||0.3056|TWO_SIDED|95.0|-2.56|8.14|||Regression, Linear||Independent variable coded: 0=Other CMI Only, Other CMI+SMART, DFB Only; 1=DFB+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit greater decreases in illness intrusiveness at the 6-month follow-up if they were assigned to receive medication information via the DrugFactsBox® format combined with gist reasoning training, delivered via the SMART Program, compared to individuals in the other three groups.||8.14|-2.56|0.3056
72570780|NCT02504671|144670143|OTHER||Mean Difference (Net)|2.18||||0.279|TWO_SIDED|95.0|-1.78|6.13||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, Vitality|||6.13|-1.78|0.279
72570781|NCT02504671|144670143|OTHER||Mean Difference (Net)|1.94||||0.584|TWO_SIDED|95.0|-5.04|8.91||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24,Vitality|||8.91|-5.04|0.584
72570782|NCT02504671|144670143|OTHER||Mean Difference (Net)|3.15||||0.346|TWO_SIDED|95.0|-3.44|9.73||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, Vitality|||9.73|-3.44|0.346
72570783|NCT02504671|144670143|OTHER||Mean Difference (Net)|2.97||||0.37|TWO_SIDED|95.0|-3.55|9.48||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, Vitality|||9.48|-3.55|0.370
72570784|NCT02504671|144670143|OTHER||Mean Difference (Net)|2.94||||0.045|TWO_SIDED|95.0|0.06|5.83||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, PCS|||5.83|0.06|0.045
72570785|NCT02504671|144670143|OTHER||Mean Difference (Net)|4.11||||0.006|TWO_SIDED|95.0|1.22|7.01||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, PCS|||7.01|1.22|0.006
72570786|NCT02504671|144670143|OTHER||Mean Difference (Net)|1.89||||0.264|TWO_SIDED|95.0|-1.44|5.23||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12,PCS|||5.23|-1.44|0.264
72570787|NCT02504671|144670143|OTHER||Mean Difference (Net)|3.55||||0.037|TWO_SIDED|95.0|0.22|6.88||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12,PCS|||6.88|0.22|0.037
72625167|NCT01098747|144780075|SUPERIORITY_OR_OTHER||Least-square (LS) mean difference|24.21|||<|0.001|TWO_SIDED|95.0|19.32|29.09||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms.|ANOVA|||Treatment difference (Ibuprofen sodium - placebo) and 95 percent (%) confidence interval (CI):based on LS means from analysis of variance(ANOVA). Type I error controlled at 5% significance level (2-sided) by testing primary endpoints sequentially: Ibuprofen sodium (IBU Na) versus(vs.) Placebo for SPRID 0-8 then time to meaningful relief(TMR), IBU Na vs. IBU (Advil and Motrin IB) for TMR. If comparison at preceding step was significant only then subsequent comparisons were significant.||29.09|19.32|<0.001
72570788|NCT02504671|144670143|OTHER||Mean Difference (Net)|2.16||||0.392|TWO_SIDED|95.0|-2.81|7.14||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, PCS|||7.14|-2.81|0.392
72570789|NCT02504671|144670143|OTHER||Mean Difference (Net)|1.65||||0.493|TWO_SIDED|95.0|-3.09|6.39||MMRM analysis adjusted for PCS Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, PCS|||6.39|-3.09|0.493
72523822|NCT02820038|144577458|SUPERIORITY|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|4.19|STANDARD_ERROR_OF_MEAN|2.11||0.0466|TWO_SIDED|95.0|0.06|8.32|||Regression, Linear||Independent variable coded: 0=Other CMI Only, Other CMI+SMART; 1=DFB Only, DFB+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit a greater decrease in illness intrusiveness between baseline and the 6-month follow-up if they were assigned to receive written medication information via the DrugFactsBox® format compared to the Other CMI format.||8.32|0.06|0.0466
72523823|NCT02820038|144577458|SUPERIORITY|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|-0.024|STANDARD_ERROR_OF_MEAN|2.11||0.9106|TWO_SIDED|95.0|-4.38|3.9|||Regression, Linear||Independent variable coded: 0=Other CMI Only, DFB Only; 1=DFB+SMART, Other CMI+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit a greater decrease in illness intrusiveness between baseline and the 6-month follow-up if they were assigned to receive gist reasoning training, delivered via the SMART Program, compared to those who were not assigned to receive this training.||3.90|-4.38|0.9106
72523824|NCT02820038|144577459|SUPERIORITY|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|-0.23|STANDARD_ERROR_OF_MEAN|0.17||0.1762|TWO_SIDED|95.0|-0.57|0.1|||Regression, Linear||Independent variable coded: 0=Other CMI Only, Other CMI+SMART, DFB Only; 1=DFB+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group..|The investigators hypothesized that participants would exhibit greater decreases in health distress at the 6-month follow-up if they were assigned to receive medication information via the DrugFactsBox® format combined with gist reasoning training, delivered via the SMART Program, compared to individuals in the other three groups.||0.10|-0.57|0.1762
72523825|NCT02820038|144577459|SUPERIORITY|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|-0.11|STANDARD_ERROR_OF_MEAN|0.13||0.4186|TWO_SIDED|95.0|-0.36|0.15|||Regression, Linear||Independent variable coded: 0=Other CMI Only, Other CMI+SMART; 1=DFB Only, DFB+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit a greater decrease in health distress between baseline and the 6-month follow-up if they were assigned to receive written medication information via the DrugFactsBox® format compared to the Other CMI format.||0.15|-0.36|0.4186
72523826|NCT02820038|144577459|SUPERIORITY|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|-0.02|STANDARD_ERROR_OF_MEAN|0.13||0.8848|TWO_SIDED|95.0|-0.28|0.24|||Regression, Linear||Independent variable coded: 0=Other CMI Only, DFB Only; 1=DFB+SMART, Other CMI+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit a greater decrease in health distress between baseline and the 6-month follow-up if they were assigned to receive gist reasoning training, delivered via the SMART Program, compared to those who were not assigned to receive this training.||0.24|-0.28|0.8848
72523827|NCT02820038|144577460|SUPERIORITY|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|0.05|STANDARD_ERROR_OF_MEAN|0.1||0.6403|TWO_SIDED|95.0|-0.15|0.25|||Regression, Linear|||The investigators hypothesized that participants would exhibit greater increases in health status at the 6-month follow-up if they were assigned to receive medication information via the DrugFactsBox® format combined with gist reasoning training, delivered via the SMART Program, compared to individuals in the other three groups.||0.25|-0.15|0.6403
72523828|NCT02820038|144577460|SUPERIORITY|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|0.01|STANDARD_ERROR_OF_MEAN|0.08||0.8766|TWO_SIDED|95.0|-0.14|0.16|||Regression, Linear||Independent variable coded: 0=Other CMI Only, Other CMI+SMART; 1=DFB Only, DFB+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit a greater increase in global health status between baseline and the 6-month follow-up if they were assigned to receive written medication information via the DrugFactsBox® format compared to the Other CMI format.||0.16|-0.14|0.8766
72523829|NCT02820038|144577460|SUPERIORITY|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|0.02|STANDARD_ERROR_OF_MEAN|0.08||0.7603|TWO_SIDED|95.0|-0.13|0.18|||Regression, Linear||Independent variable coded: 0=Other CMI Only, DFB Only; 1=DFB+SMART, Other CMI+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit a greater improvement in global health status between baseline and the 6-month follow-up if they were assigned to receive gist reasoning training, delivered via the SMART Program, compared to those who were not assigned to receive this training.||0.18|-0.13|0.7603
72523830|NCT02820038|144577461|SUPERIORITY|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|0.1|STANDARD_ERROR_OF_MEAN|0.27||0.7093|TWO_SIDED|95.0|-0.43|0.63|||Regression, Linear||Independent variable coded: 0=Other CMI Only, Other CMI+SMART, DFB Only; 1=DFB+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit greater decreases in disease activity at the 6-month follow-up if they were assigned to receive medication information via the DrugFactsBox® format combined with gist reasoning training, delivered via the SMART Program, compared to individuals in the other three groups.||0.63|-0.43|0.7093
72523831|NCT02820038|144577461|SUPERIORITY|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|0.11|STANDARD_ERROR_OF_MEAN|0.21||0.5941|TWO_SIDED|95.0|-0.3|0.52|||Regression, Linear||Independent variable coded: 0=Other CMI Only, Other CMI+SMART; 1=DFB Only, DFB+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit a greater decrease in disease activity between baseline and the 6-month follow-up if they were assigned to receive written medication information via the DrugFactsBox® format compared to the Other CMI format.||0.52|-0.30|0.5941
72523832|NCT02820038|144577461|SUPERIORITY|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|-0.01|STANDARD_ERROR_OF_MEAN|0.21||0.9476|TWO_SIDED|95.0|-0.42|0.4|||Regression, Linear||Independent variable coded: 0=Other CMI Only, DFB Only; 1=DFB+SMART, Other CMI+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit a greater decrease in disease activity between baseline and the 6-month follow-up if they were assigned to receive gist reasoning training, delivered via the SMART Program, compared to those who were not assigned to receive this training.||0.40|-0.42|0.9476
72625168|NCT01098747|144780076|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|12.8|||<|0.001|TWO_SIDED|95.0|6.78|24.15||p-value was calculated using the PH model with treatment, baseline PSR and gender terms.|Proportional hazards model|||Hazard Ratio (HR) and corresponding 95% CI were calculated based on the Wald statistic from the proportional hazards (PH) model. Type I error controlled at 5% significance level (2-sided) by testing primary endpoints sequentially: IBU Na vs. Placebo for SPRID 0-8 then TMR, IBU Na vs. IBU (Advil and Motrin IB) for TMR. If comparison at preceding step was significant only then subsequent comparisons were significant.||24.15|6.78|<0.001
72523833|NCT02820038|144577462|SUPERIORITY|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|-0.09|STANDARD_ERROR_OF_MEAN|0.8||0.9128|TWO_SIDED|95.0|-1.65|1.48|||Regression, Linear||Independent variable coded: 0=Other CMI Only, Other CMI+SMART, DFB Only; 1=DFB+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit greater decreases in depression at the 6-month follow-up if they were assigned to receive medication information via the DrugFactsBox® format combined with gist reasoning training, delivered via the SMART Program, compared to individuals in the other three groups.||1.48|-1.65|0.9128
72523834|NCT02820038|144577462|SUPERIORITY|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|-0.29|STANDARD_ERROR_OF_MEAN|0.62||0.6312|TWO_SIDED|95.0|-1.5|0.91|||Regression, Linear||Independent variable coded: 0=Other CMI Only, Other CMI+SMART; 1=DFB Only, DFB+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit a greater decrease in depression between baseline and the 6-month follow-up if they were assigned to receive written medication information via the DrugFactsBox® format compared to the Other CMI format.||0.91|-1.50|0.6312
72523835|NCT02820038|144577462|SUPERIORITY|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|-0.35|STANDARD_ERROR_OF_MEAN|0.62||0.5766|TWO_SIDED|95.0|-1.57|0.87|||Regression, Linear||Independent variable coded: 0=Other CMI Only, DFB Only; 1=DFB+SMART, Other CMI+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit a greater decrease in depression between baseline and the 6-month follow-up if they were assigned to receive gist reasoning training, delivered via the SMART Program, compared to those who were not assigned to receive this training.||0.87|-1.57|0.5766
72523836|NCT02820038|144577463|SUPERIORITY|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|-1.3|STANDARD_ERROR_OF_MEAN|1.04||0.2123|TWO_SIDED|95.0|-3.34|0.75|||Regression, Linear||Independent variable coded: 0=Other CMI Only, Other CMI+SMART, DFB Only; 1=DFB+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit greater decreases in fatigue at the 6-month follow-up if they were assigned to receive medication information via the DrugFactsBox® format combined with gist reasoning training, delivered via the SMART Program, compared to individuals in the other three groups.||0.75|-3.34|0.2123
72523837|NCT02820038|144577463|SUPERIORITY|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|-0.89|STANDARD_ERROR_OF_MEAN|0.81||0.2691|TWO_SIDED|95.0|-2.48|0.7|||Regression, Linear||Independent variable coded: 0=Other CMI Only, Other CMI+SMART; 1=DFB Only, DFB+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit a greater decrease in fatigue between baseline and the 6-month follow-up if they were assigned to receive written medication information via the DrugFactsBox® format compared to the Other CMI format.||0.70|-2.48|0.2691
72523838|NCT02820038|144577463|SUPERIORITY|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|-0.47|STANDARD_ERROR_OF_MEAN|0.81||0.5655|TWO_SIDED|95.0|-2.06|1.13|||Regression, Linear||Independent variable coded: 0=Other CMI Only, DFB Only; 1=DFB+SMART, Other CMI+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit a greater decrease in fatigue between baseline and the 6-month follow-up if they were assigned to receive gist reasoning training, delivered via the SMART Program, compared to those who were not assigned to receive this training.||1.13|-2.06|0.5655
72523839|NCT02820038|144577464|SUPERIORITY|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|2.52|STANDARD_ERROR_OF_MEAN|4.1||0.5364|TWO_SIDED|95.0|-5.51|10.55|||Regression, Linear||Independent variable coded: 0=Other CMI Only, Other CMI+SMART, DFB Only; 1=DFB+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit greater increases in health literacy at the 6-month follow-up if they were assigned to receive medication information via the DrugFactsBox® format combined with gist reasoning training, delivered via the SMART Program, compared to individuals in the other three groups.||10.55|-5.51|0.5364
72523840|NCT02820038|144577464|SUPERIORITY|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|1.67|STANDARD_ERROR_OF_MEAN|3.24||0.605|TWO_SIDED|95.0|-4.68|8.01|||Regression, Linear||Independent variable coded: 0=Other CMI Only, Other CMI+SMART; 1=DFB Only, DFB+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit a greater increase in health literacy between baseline and the 6-month follow-up if they were assigned to receive written medication information via the DrugFactsBox® format compared to the Other CMI format.||8.01|-4.68|0.6050
72406412|NCT02942017|144321622|SUPERIORITY||LS Mean Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.203||0.595|TWO_SIDED|95.0|-0.51|0.29|||MMRM|||Work and Activities, Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.29|-0.51|0.5950
72406413|NCT02942017|144321622|SUPERIORITY||LS Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.2||0.9636|TWO_SIDED|95.0|-0.39|0.41|||MMRM|||Work and Activities, Hour 24 : MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.41|-0.39|0.9636
72406414|NCT02942017|144321622|SUPERIORITY||LS Mean Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.196||0.5836|TWO_SIDED|95.0|-0.5|0.28|||MMRM|||Work and Activities, Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.28|-0.50|0.5836
72406415|NCT02942017|144321622|SUPERIORITY||LS Mean Difference|-0.26|STANDARD_ERROR_OF_MEAN|0.184||0.1568|TWO_SIDED|95.0|-0.63|0.1|||MMRM|||Work and Activities, Hour 48 : MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.10|-0.63|0.1568
72406416|NCT02942017|144321622|SUPERIORITY||LS Mean Difference|-0.44|STANDARD_ERROR_OF_MEAN|0.177||0.0155|TWO_SIDED|5.0|-0.79|-0.09|||Wilcoxon (Mann-Whitney)|||Work and Activities, Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.09|-0.79|0.0155
72406417|NCT02942017|144321622|SUPERIORITY||LS Mean Difference|-0.38|STANDARD_ERROR_OF_MEAN|0.192||0.0504|TWO_SIDED|95.0|-0.76|0.0|||MMRM|||Work and Activities, Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.00|-0.76|0.0504
72523841|NCT02820038|144577464|SUPERIORITY|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|-0.31|STANDARD_ERROR_OF_MEAN|3.24||0.924|TWO_SIDED|95.0|-6.66|6.05|||Regression, Linear||Independent variable coded: 0=Other CMI Only, DFB Only; 1=DFB+SMART, Other CMI+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit a greater increase in health literacy between baseline and the 6-month follow-up if they were assigned to receive gist reasoning training, delivered via the SMART Program, compared to those who were not assigned to receive this training.||6.05|-6.66|0.9240
72523842|NCT02820038|144577465|SUPERIORITY||Odds Ratio (OR)|0.9||||0.7871|TWO_SIDED|95.0|0.43|1.89|||Regression, Logistic||Modeled probability of attending at least one class session. Independent variable coded: 0=Other CMI Only, Other CMI+SMART, DFB Only; 1=DFB+SMART|The investigators hypothesized that participants would be more likely to participate in the BetterChoices, BetterHealth program if they were assigned to receive medication information via the DrugFactsBox® format combined with gist reasoning training, delivered via the SMART Program, compared to individuals in the other three groups.||1.89|0.43|0.7871
72523843|NCT02820038|144577465|SUPERIORITY||Odds Ratio (OR)|1.189||||0.5815|TWO_SIDED|95.0|0.643|2.198|||Regression, Logistic||Modeled probability of attending at least one class. Independent variable coded: 0=Other CMI Only, Other CMI+SMART; 1=DFB Only, DFB+SMART.|The investigators hypothesized that participants would be more likely to participate in at least one session of the BetterChoices,BetterHealth program if they were assigned to receive written medication information via the DrugFactsBox® format compared to the Other CMI format.||2.198|0.643|0.5815
72523844|NCT02820038|144577465|SUPERIORITY||Odds Ratio (OR)|0.679||||0.2211|TWO_SIDED|95.0|0.366|1.262|||Regression, Logistic||Modeled probability of attending at least one class. Independent variable coded: 0=Other CMI Only, DFB Only; 1=Other CMI+SMART, DFB+SMART.|The investigators hypothesized that participants would be more likely to participate in at least one session of the BetterChoices, BetterHealth program if they were assigned to receive gist reasoning training, delivered via the SMART Program, compared to those who were not assigned to receive this training.||1.262|0.366|0.2211
72523845|NCT02820038|144577466|SUPERIORITY||Odds Ratio (OR)|0.804||||0.574|TWO_SIDED|95.0|0.38|1.72|||Regression, Logistic||Modeled probability of viewing at least one page on website. Independent variable coded: 0=Other CMI Only, Other CMI+SMART, DFB Only; 1=DFB+SMART|The investigators hypothesized that participants would be more likely to use the RA Self-Management website if they were assigned to receive medication information via the DrugFactsBox® format combined with gist reasoning training, delivered via the SMART Program, compared to individuals in the other three groups.||1.72|0.38|0.5740
72570790|NCT02504671|144670143|OTHER||Mean Difference (Net)|1.16||||0.577|TWO_SIDED|95.0|-2.94|5.26||MMRM analysis adjusted for MCS Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, MCS|||5.26|-2.94|0.577
72570791|NCT02504671|144670143|OTHER||Mean Difference (Net)|0.1||||0.964|TWO_SIDED|95.0|-4.01|4.2||MMRM analysis adjusted for MCS Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, MCS|||4.20|-4.01|0.964
72570792|NCT02504671|144670143|OTHER||Mean Difference (Net)|1.97||||0.37|TWO_SIDED|95.0|-2.35|6.28||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, MCS|||6.28|-2.35|0.370
72406418|NCT02942017|144321622|SUPERIORITY||LS Mean Difference|-0.28|STANDARD_ERROR_OF_MEAN|0.212||0.1865|TWO_SIDED|95.0|-0.7|0.14|||MMRM|||Work and Activities, Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.14|-0.70|0.1865
72523846|NCT02820038|144577466|SUPERIORITY||Odds Ratio (OR)|1.425||||0.1278|TWO_SIDED|95.0|0.766|2.649|||Regression, Logistic||Modeled probability of viewing at least one page on website. Independent variable coded: 0=Other CMI Only, Other CMI+SMART; 1=DFB Only, DFB+SMART.|The investigators hypothesized that participants would be more likely to visit the RA Self-Management Website if they were assigned to receive written medication information via the DrugFactsBox® format compared to the Other CMI format.||2.649|0.766|0.1278
72523847|NCT02820038|144577466|SUPERIORITY||Odds Ratio (OR)|0.614||||0.1278|TWO_SIDED|95.0|0.328|1.15|||Regression, Logistic||Modeled probability of viewing at least one page on website. Independent variable coded: 0=Other CMI Only, DFB Only; 1=Other CMI+SMART, DFB+SMART.|The investigators hypothesized that participants would be more likely to visit the RA Self-Management Website if they were assigned to receive gist reasoning training, delivered via the SMART Program, compared to those who were not assigned to receive this training.||1.15|0.328|0.1278
72523848|NCT02820038|144577467|SUPERIORITY|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|11.9|STANDARD_ERROR_OF_MEAN|8.7||0.17|TWO_SIDED|95.0|-5.2|28.9|||Regression, Linear||Independent variable coded: 0=Other CMI Only, Other CMI+SMART, DFB Only; 1=DFB+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit greater increases in visual selective learning between baseline and the 6-month follow-up if they were assigned to receive medication information via the DrugFactsBox® format combined with gist reasoning training, delivered via the SMART Program, compared to individuals in the other three groups.||28.9|-5.2|0.17
72523849|NCT02820038|144577467|SUPERIORITY|Regression model adjusted for baseline value of the dependent variable|Mean Difference (Net)|16.0|STANDARD_ERROR_OF_MEAN|6.9||0.02|TWO_SIDED|95.0|2.5|29.5|||Regression, Linear||Independent variable coded: 0=Other CMI Only, Other CMI+SMART; 1=DFB Only, DFB+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit a greater increase in visual selective learning between baseline and the 6-month follow-up if they were assigned to receive written medication information via the DrugFactsBox® format compared to the Other CMI format.||29.5|2.5|0.02
72523850|NCT02820038|144577467|SUPERIORITY|Regression model adjusted for baseline values of the dependent variable.|Mean Difference (Net)|5.6|STANDARD_ERROR_OF_MEAN|6.9||0.42|TWO_SIDED|95.0|-8.1|19.2|||Regression, Linear||Independent variable coded: 0=Other CMI Only, DFB Only; 1=Other CMI+SMART, DFB+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would experience a greater increase in visual selective learning between baseline and the 6-month follow-up if they were assigned to receive gist reasoning training, delivered via the SMART Program, compared to those who were not assigned to receive this training.||19.2|-8.1|0.42
72523851|NCT02820038|144577468|SUPERIORITY||Mean Difference (Net)|-2.2|STANDARD_ERROR_OF_MEAN|0.15||0.15|TWO_SIDED|95.0|-5.2|0.8|||Regression, Linear||Independent variable coded: 0=Other CMI Only, Other CMI+SMART, DFB Only; 1=DFB+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit greater medication self-management knowledge at the 6-month follow-up if they were assigned to receive medication information via the DrugFactsBox® format combined with gist reasoning training, delivered via the SMART Program, compared to individuals in the other three groups.||0.8|-5.2|0.15
72523852|NCT02820038|144577468|SUPERIORITY||Mean Difference (Net)|-2.1|STANDARD_ERROR_OF_MEAN|1.2||0.07|TWO_SIDED|95.0|-4.4|0.3|||Regression, Linear||Independent variable coded: 0=Other CMI Only, Other CMI+SMART; 1=DFB Only, DFB+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit greater medication self-management knowledge at the 6-month follow-up if they were assigned to receive written medication information via the DrugFactsBox® format compared to the Other CMI format.||0.3|-4.4|0.07
72523853|NCT02820038|144577468|SUPERIORITY||Mean Difference (Net)|-1.8|STANDARD_ERROR_OF_MEAN|1.2||0.13|TWO_SIDED|95.0|-4.2|0.6|||Regression, Linear||Independent variable coded: 0=Other CMI Only, DFB Only; 1=DFB+SMART, DFB+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would experience greater medication self-management knowledge at the 6-month follow-up if they were assigned to receive gist reasoning training, delivered via the SMART Program, compared to those who were not assigned to receive this training.||0.6|-4.2|0.13
72523854|NCT02820038|144577469|SUPERIORITY||Mean Difference (Net)|0.05|STANDARD_ERROR_OF_MEAN|0.12||0.68|TWO_SIDED|95.0|-0.19|0.29|||Regression, Linear||Independent variable coded: 0=Other CMI Only, Other CMI+SMART, DFB Only; 1=DFB+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit greater verbatim recall of information concerning medication benefits and risks at the 6-month follow-up if they were assigned to receive medication information via the DrugFactsBox® format combined with gist reasoning training, delivered via the SMART Program, compared to individuals in the other three groups.||0.29|-0.19|0.68
72625169|NCT01098747|144780076|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.59|||<|0.001|TWO_SIDED|95.0|1.22|2.06||p-value was calculated using the PH model with treatment, baseline PSR and gender terms.|Proportional hazards model|||HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model. Type I error controlled at 5% significance level (2-sided) by testing primary endpoints sequentially: IBU Na vs. Placebo for SPRID 0-8 then TMR, IBU Na vs. IBU (Advil and Motrin IB) for TMR. If comparison at preceding step was significant only then subsequent comparisons were significant.||2.06|1.22|<0.001
72523855|NCT02820038|144577469|SUPERIORITY||Mean Difference (Net)|0.12|STANDARD_ERROR_OF_MEAN|0.1||0.2|TWO_SIDED|95.0|-0.06|0.31|||Regression, Linear||Independent variable coded: 0=Other CMI Only, Other CMI+SMART; 1=DFB Only, DFB+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit greater verbatim recall of information concerning medication benefits and risks at the 6-month follow-up if they were assigned to receive written medication information via the DrugFactsBox® format compared to the Other CMI format.||0.31|-0.06|0.20
72523856|NCT02820038|144577469|SUPERIORITY||Mean Difference (Net)|0.001|STANDARD_ERROR_OF_MEAN|0.1||0.99|TWO_SIDED|95.0|-0.19|0.19|||Regression, Linear||Independent variable coded: 0=Other CMI Only, DFB Only; 1=Other CMI+SMART, DFB+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit greater verbatim recall of information concerning medication benefits and risks at the 6-week follow-up if they were assigned to receive gist reasoning training, delivered via the SMART Program, compared to those who were not assigned to receive this training.||0.19|-0.19|0.99
72523857|NCT02820038|144577470|SUPERIORITY||Odds Ratio (OR)|2.105||||0.0028|TWO_SIDED|95.0|1.291|3.432|||Regression, Logistic|||The investigators hypothesized that participants would be more likely to view at least one webpage if they were assigned to receive written medication information via the DrugFactsBox® format compared to the Other CMI format.|Modeled probability of viewing at least one webpage. Independent variable coded: 0=Other CMI Only, Other CMI+SMART; 1=DFB Only, DFB+SMART.|3.432|1.291|0.0028
72523858|NCT02820038|144577471|SUPERIORITY||Mean Difference (Net)|-0.84|STANDARD_ERROR_OF_MEAN|0.45||0.0601|TWO_SIDED|95.0|-1.71|0.04|||Regression, Linear||Independent variable coded: 0=Other CMI Only, Other CMI+SMART; 1=DFB Only, DFB+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would view more webpages if they were assigned to receive written medication information via the DrugFactsBox® format compared to the Other CMI format.||0.04|-1.71|0.0601
72523859|NCT02820038|144577472|SUPERIORITY||Odds Ratio (OR)|0.91||||0.9|TWO_SIDED|95.0|0.22|3.81|||Regression, Logistic||Independent variable coded: 0=Other Consumer Medication Information (CMI) Only, Other CMI+SMART, DrugFactsBox® (DFB) Only; 1=DFB+SMART|The investigators hypothesized that participants would be more likely to be using at least one DMARD (Disease-Modifying Antirheumatic Drug) at the 6-month follow-up if they were assigned to receive medication information via the DrugFactsBox® format combined with gist reasoning training, delivered via the SMART Program, compared to individuals in the other three groups.||3.81|0.22|0.90
72523860|NCT02820038|144577472|SUPERIORITY|Regression model adjusted for baseline value of the dependent variable.|Odds Ratio (OR)|0.75||||0.63|TWO_SIDED|95.0|0.24|2.35|||Regression, Logistic||. Independent variable coded: 0=Other Consumer Medication Information (CMI) Only, Other CMI+SMART; 1=DFB Only, DFB+SMART|The investigators hypothesized that participants would exhibit a greater increase in the percentage of participants using at least one DMARD (Disease-Modifying Antirheumatic Drug) between baseline and the 6-month follow-up if they were assigned to receive written medication information via the DrugFactsBox® format compared to the Other CMI format.||2.35|0.24|0.63
72523861|NCT02820038|144577472|SUPERIORITY|Regression model adjusted for baseline value of the dependent variable.|Odds Ratio (OR)|1.15||||0.81|TWO_SIDED|95.0|0.37|3.54|||Regression, Logistic||Independent variable coded: 0=Other Consumer Medication Information (CMI) Only, DrugFactsBox® (DFB) Only; 1=Other CMI+SMART, DFB+SMART|The investigators hypothesized that participants would experience a greater increase in the percentage of participants using at least one DMARD (Disease-Modifying Antirheumatic Drug) between baseline and the 6-month follow-up if they were assigned to receive gist reasoning training, delivered via the SMART Program, compared to those who were not assigned to receive this training.||3.54|0.37|0.81
72523862|NCT02623699|144577486|SUPERIORITY||least square (LS) mean difference|1.2|STANDARD_ERROR_OF_MEAN|2.22|=|0.9689|TWO_SIDED|95.0|-3.19|5.53||Joint rank p-value was calculated from ANCOVA model which included treatment as fixed effect, adjusts for covariates: Baseline disease duration since symptom onset, baseline ALSFRS-R total score, and use of riluzole or edaravone.|Joint rank||ANCOVA model included treatment as a fixed effect, adjusts for the covariates: Baseline disease duration since symptom onset, baseline ALSFRS-R total score, and use of riluzole or edaravone.|Joint rank test combining function and mortality were used for statistical inference and the estimates were from the Analysis of covariance (ANCOVA) for change from baseline. Multiple imputation was used to handle missing data for withdrawals other than death in the joint rank analysis. Multiple imputation was used to handle all missing data in the ANCOVA for change from baseline.||5.53|-3.19|= 0.9689
72523863|NCT02623699|144577487|SUPERIORITY||Difference in LS geometric mean ratio|0.67|||<|0.0001|TWO_SIDED|95.0|0.53|0.84|||Wilcoxon rank sum test|||Difference in LS geometric mean ratio (BIIB067:Placebo) was calculated.||0.84|0.53|< 0.0001
72523864|NCT02623699|144577487|SUPERIORITY||Difference in LS geometric mean ratio|0.75|||=|0.0002|TWO_SIDED|95.0|0.6|0.95|||Wilcoxon rank sum test|||Difference in LS geometric mean ratio (BIIB067:Placebo) was calculated.||0.95|0.60|=0.0002
72523865|NCT02623699|144577487|SUPERIORITY||Difference in LS geometric mean ratio|0.81|||=|0.0641|TWO_SIDED|95.0|0.65|1.02|||Wilcoxon rank sum test|||Difference in LS geometric mean ratio (BIIB067:Placebo) was calculated.||1.02|0.65|=0.0641
72523866|NCT02623699|144577487|SUPERIORITY||Difference in LS geometric mean ratio|0.67|||<|0.0001|TWO_SIDED|95.0|0.53|0.84|||Wilcoxon rank sum test|||Difference in LS geometric mean ratio (BIIB067:Placebo) was calculated.||0.84|0.53|<0.0001
72570793|NCT02504671|144670143|OTHER||Mean Difference (Net)|3.25||||0.138|TWO_SIDED|95.0|-1.05|7.54||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, MCS|||7.54|-1.05|0.138
72570794|NCT02504671|144670143|OTHER||Mean Difference (Net)|1.36||||0.667|TWO_SIDED|95.0|-4.85|7.56||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, MCS|||7.56|-4.85|0.667
72570795|NCT02504671|144670143|OTHER||Mean Difference (Net)|3.79||||0.203|TWO_SIDED|95.0|-4.85|7.56||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, MCS|||7.56|-4.85|0.203
72570796|NCT02504671|144670143|OTHER||Mean Difference (Net)|3.45||||0.023|TWO_SIDED|95.0|0.49|6.41||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 4, Bodily pain|||6.41|0.49|0.023
72625170|NCT01098747|144780077|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|12.36|||<|0.001|TWO_SIDED|95.0|6.51|23.46||p-value was calculated using the PH model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Proportional hazards model|||HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model.||23.46|6.51|<0.001
72406419|NCT02942017|144321622|SUPERIORITY||LS Mean Difference|-0.43|STANDARD_ERROR_OF_MEAN|0.22||0.0518|TWO_SIDED|95.0|-0.87|0.0|||MMRM|||Work and Activities, Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.00|-0.87|0.0518
72406420|NCT02942017|144321622|SUPERIORITY||LS Mean Difference|0.05|STANDARD_ERROR_OF_MEAN|0.239||0.833|TWO_SIDED|95.0|-0.42|0.53|||MMRM|||Work and Activities, Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.53|-0.42|0.8330
72406421|NCT02942017|144321622|SUPERIORITY||LS Mean Difference|0.04|STANDARD_ERROR_OF_MEAN|0.191||0.844|TWO_SIDED|95.0|-0.34|0.42|||MMRM|||Work and Activities, Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.42|-0.34|0.8440
72406422|NCT02942017|144321622|SUPERIORITY||LS Mean Difference|0.09|STANDARD_ERROR_OF_MEAN|0.121||0.4602|TWO_SIDED|95.0|-0.15|0.33|||MMRM|||Retardation, Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.33|-0.15|0.4602
72406423|NCT02942017|144321622|SUPERIORITY||LS Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|0.117||0.0891|TWO_SIDED|95.0|-0.03|0.43|||MMRM|||Retardation, Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.43|-0.03|0.0891
72406424|NCT02942017|144321622|SUPERIORITY||LS Mean Difference|0.12|STANDARD_ERROR_OF_MEAN|0.117||0.3088|TWO_SIDED|95.0|-0.11|0.35|||MMRM|||Retardation, Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.35|-0.11|0.3088
72523867|NCT02623699|144577488|SUPERIORITY||Difference in LS geometric mean ratio|0.62|||<|0.0001|TWO_SIDED|95.0|0.49|0.78||The analysis was based on ANCOVA model with natural log transformed data. P-value for this secondary outcome measure (OM) is nominal as statistical significance was not met on the primary OM.|ANCOVA|||The ANCOVA model included covariates for the corresponding baseline value i.e. log value, baseline disease duration since symptom onset, and use of riluzole or edaravone. Multiple imputation was used to handle missing data for withdrawals. Difference in LS geometric mean ratio to baseline (BIIB067:Placebo) was calculated.||0.78|0.49|< 0.0001
72523868|NCT02623699|144577489|SUPERIORITY||Difference in LS geometric mean ratio|0.33|||<|0.0001|TWO_SIDED|95.0|0.25|0.45||The analysis was based on ANCOVA model with natural log transformed data. The model included covariates for the corresponding baseline value i.e. log value, baseline disease duration since symptom onset, and use of riluzole or edaravone.|ANCOVA|P-value for this secondary OM is nominal as statistical significance was not met on the primary OM.||Difference in LS geometric mean ratio (BIIB067:Placebo) was calculated.||0.45|0.25|< 0.0001
72523869|NCT02623699|144577490|SUPERIORITY||LS mean difference|7.9|STANDARD_ERROR_OF_MEAN|5.829|=|0.3233|TWO_SIDED|95.0|-3.528|19.322||Joint rank p-value was calculated from ANCOVA model which included treatment as fixed effect, adjusts for covariates: Baseline disease duration since symptom onset, baseline ALSFRS-R total score, baseline SVC, and use of riluzole or edaravone.|Joint rank|P-value for this secondary OM is nominal as statistical significance was not met on the primary OM.|ANCOVA model included treatment as a fixed effect, adjusts for the covariates: Baseline disease duration since symptom onset, baseline ALSFRS-R total score, baseline SVC, and use of riluzole or edaravone.|Joint rank test combining function and mortality were used for statistical inference and the estimates were from the ANCOVA for change from baseline. Multiple imputation was used to handle missing data for withdrawals other than death in the joint rank analysis. Multiple imputation was used to handle all missing data in the ANCOVA for change from baseline.||19.322|-3.528|= 0.3233
72523870|NCT02623699|144577491|SUPERIORITY||LS mean difference|0.02|STANDARD_ERROR_OF_MEAN|0.118|=|0.839|TWO_SIDED|95.0|-0.207|0.255||ANCOVA model included treatment as fixed effect and adjusts for following covariates: Baseline disease duration since symptom onset, baseline HHD overall megascore, and use of riluzole/edaravone. Missing data were handled using multiple imputation.|ANCOVA|P-value for this secondary OM is nominal as statistical significance was not met on the primary OM.||||0.255|-0.207|= 0.8390
72523871|NCT00089999|144577537|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.8||||0.691|TWO_SIDED|95.0|0.3|1.9|||Fisher Exact|||||1.9|0.3|0.691
72523872|NCT00089999|144577538|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.7||||0.443|TWO_SIDED|95.0|0.3|1.6|||Fisher Exact||Overall Response (i.e. sum of Complete and Partial Responses) comparison|||1.6|0.3|0.443
72523873|NCT00616772|144577545|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.006||||0.22|TWO_SIDED|95.0|-0.016|0.004|||Repeated measures linear mixed model|Fixed effects for baseline cIMT, baseline atorvastatin dose, central imaging site, treatment group, time; interaction between treatment group and time||||0.004|-0.016|0.220
72523874|NCT00616772|144577546|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.002||||0.813|TWO_SIDED|95.0|-0.014|0.011|||Repeated measures linear mixed model|Fixed effects for baseline atorvastatin dose, imaging site, treatment, time; interaction between treatment group and time; baseline cIMT as covariate.||||0.011|-0.014|0.813
72523875|NCT00616772|144577547|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.007||||0.249|TWO_SIDED|95.0|-0.018|0.005|||Repeated measures linear mixed model|Fixed effects for baseline atorvastatin dose, imaging site, treatment, time; interaction between treatment group and time; baseline IMT as covariate||||0.005|-0.018|0.249
72523876|NCT00616772|144577548|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.005||||0.487|TWO_SIDED|95.0|-0.02|0.01|||Repeated measures linear mixed model|Fixed effects for baseline atorvastatin dose, imaging site, treatment, time; interaction between treatment group and time; baseline IMT as covariate||||0.010|-0.020|0.487
72523877|NCT00616772|144577549|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.016||||0.112|TWO_SIDED|95.0|-0.004|0.035|||Repeated measures linear mixed model|Fixed effects for baseline atorvastatin dose, imaging site, treatment, time; interaction between treatment group and time; baseline IMT as covariate||||0.035|-0.004|0.112
72523878|NCT04283773|144577562|SUPERIORITY||Median Difference (Final Values)|0.001|STANDARD_DEVIATION|1.5||0.001|TWO_SIDED|95.0|0.0|8.0||The test of significance is Kruskal Wallis was used to examine the Difference in Median between groups. Post-hoc test with Bonferroni Correction was used for Pairwise comparisons . A p-value \< 0.05 was considered significant.|Kruskal-Wallis|||Assessment of statistical differences in P16 expression between 3 groups. The immunohistochemical evaluation is done using German- semiquantitative scoring system. The score ranges from ( 0, 1,2,3,4,6,8,9 and 12). The data will entered on SPSS,version 24 as numbers. The test of significance is Kruskal Wallis was used to examine the Difference in Median between groups. Post-hoc test with Bonferroni Correction was used for Pairwise comparisons . A p-value \< 0.05 was considered significant.||8|0|0.001
72523879|NCT04283773|144577563|SUPERIORITY||Hazard Ratio, log|0.009||||0.009|TWO_SIDED|95.0|0.0|8.0||Data were analysed using IBM-SPSS version 24. Correlation analysis was used (Spearman' Ranked correlation, 2-tailed). A p-value \< 0.05 was considered significant.|Spearman's rank correlation coefficient(|||Correlation between Ki 67 expression using percentage of Ki67 positive nuclei and P16 cytoplasmic expression using German semi quantitative score among MOGCT group. Data were analysed using IBM-SPSS version 24. Correlation analysis was used (Spearman' Ranked correlation, 2-tailed). A p-value \< 0.05 was considered significant.||8|0|0.009
72570797|NCT02504671|144670143|OTHER||Mean Difference (Net)|5.08|||<|0.001|TWO_SIDED|95.0|2.14|8.03||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 4, Bodily pain|||8.03|2.14|<0.001
72570798|NCT02504671|144670143|OTHER||Mean Difference (Net)|2.11||||0.249|TWO_SIDED|95.0|-1.49|5.7||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 12, Bodily pain|||5.70|-1.49|0.249
72570799|NCT02504671|144670143|OTHER||Mean Difference (Net)|3.43||||0.059|TWO_SIDED|95.0|-0.13|6.99||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 12, Bodily pain|||6.99|-0.13|0.059
72570800|NCT02504671|144670143|OTHER||Mean Difference (Net)|4.72||||0.134|TWO_SIDED|95.0|-1.47|10.9||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 24, Bodily pain|||10.90|-1.47|0.134
72625171|NCT01098747|144780077|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.8|||<|0.001|TWO_SIDED|95.0|1.38|2.34||p-value was calculated using the PH model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Proportional hazards model|||HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model.||2.34|1.38|<0.001
72625172|NCT01098747|144780078|SUPERIORITY_OR_OTHER||LS mean difference|0.35||||0.007|TWO_SIDED|95.0|0.1|0.6||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||0.25 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS mean from the ANOVA model.||0.60|0.10|0.007
72523880|NCT04283773|144577564|SUPERIORITY|One-way ANOVA was used to examine the Difference in Mean between groups. Post-hoc test with Bonferroni Correction was used for Pairwise comparisons .Data was expressed as mean (SD). P value is significant if less than 0.05.|Mean Difference (Final Values)|11.0|STANDARD_DEVIATION|1.5||0.699|TWO_SIDED|80.0|9.5|13.0||One-way ANOVA was used to examine the Difference in Mean between groups. Post-hoc test with Bonferroni Correction was used for Pairwise comparisons .Data was expressed as mean (SD). P value is significant if less than 0.05.|ANOVA|||Correlation between P16 cytoplasmic score using German semi-quantitative system and FIGO staging of MOGCTs was done via One-way ANOVA was used to examine the Difference in Mean between groups. Post-hoc test with Bonferroni Correction was used for Pairwise comparisons .Data was expressed as mean (SD).||13|9.5|0.699
72523881|NCT02128958|144577578|OTHER|||||||0.536|||||||Log Rank|||The between-treatment comparison (CF102 vs Placebo) of Overall Survival will be performed using the log rank test as the primary analysis.||||0.536
72523882|NCT02128958|144577579|OTHER|||||||0.371|||||||Log Rank|||The between-treatment comparison (CF102 vs Placebo) of Time to Progression will be performed using the log rank test as the primary analysis.||||.371
72523883|NCT02128958|144577580|OTHER|||||||0.521|||||||Log Rank|||The between-treatment comparison (CF102 vs Placebo) will be performed on Time to Progression Free Survival using the logrank test.||||0.521
72523884|NCT02128958|144577583|OTHER|||||||0.988|||||||ANCOVA|||Between-treatment comparisons of ALT will be performed at Cycle 11 Day 15 using ANCOVA with CFB as the dependent variable and the Baseline value of the variable as the covariate.||||0.988
72570801|NCT02504671|144670143|OTHER||Mean Difference (Net)|5.2||||0.078|TWO_SIDED|95.0|-0.58|10.97||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 24, Bodily pain|||10.97|-0.58|0.078
72570802|NCT02504671|144670143|OTHER||Mean Difference (Net)|1.65||||0.275|TWO_SIDED|95.0|-1.32|4.62||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 4, General health|||4.62|-1.32|0.275
72570803|NCT02504671|144670143|OTHER||Mean Difference (Net)|1.94||||0.199|TWO_SIDED|95.0|-1.03|4.91||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 4, General health|||4.91|-1.03|0.199
72406425|NCT02942017|144321622|SUPERIORITY||LS Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.112||0.856|TWO_SIDED|95.0|-0.24|0.2|||MMRM|||Retardation, Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.20|-0.24|0.8560
72523885|NCT02128958|144577583|OTHER|||||||0.989|||||||ANCOVA|||Between-treatment comparisons of AST will be performed at Cycle 11 Day 15 using ANCOVA with CFB as the dependent variable and the Baseline value of the variable as the covariate.||||0.989
72523886|NCT02128958|144577583|OTHER|||||||0.717|||||||ANCOVA|||Between-treatment comparisons of Albumin will be performed at Cycle 11 Day 15 using ANCOVA with CFB as the dependent variable and the Baseline value of the variable as the covariate.||||0.717
72523887|NCT02128958|144577583|OTHER|||||||0.891|||||||ANCOVA|||Between-treatment comparisons of Bilirubin (direct) will be performed at Cycle 11 Day 15 using ANCOVA with CFB as the dependent variable and the Baseline value of the variable as the covariate.||||0.891
72523888|NCT02128958|144577583|OTHER|||||||0.275|||||||ANCOVA|||Between-treatment comparisons of Bilirubin (Total) will be performed at Cycle 11 Day 15 using ANCOVA with CFB as the dependent variable and the Baseline value of the variable as the covariate.||||0.275
72523889|NCT02128958|144577583|OTHER|||||||0.549|||||||ANCOVA|||Between-treatment comparisons of PT will be performed at Cycle 11 Day 15 using ANCOVA with CFB as the dependent variable and the Baseline value of the variable as the covariate.||||0.549
72523890|NCT02128958|144577583|OTHER|||||||0.479|||||||ANCOVA|||Between-treatment comparisons of INR will be performed at Cycle 11 Day 15 using ANCOVA with CFB as the dependent variable and the Baseline value of the variable as the covariate.||||0.479
72523891|NCT00981292|144577591|SUPERIORITY_OR_OTHER||||||<|0.05||95.0||||A Bonferroni adjustment was made for multiplicity.|ANOVA|||This data was analysed by two-way repeated measures ANOVA (task \[epoch\] x treatment). In the case of those analyses that showed a significant main effect of treatment or a task/epoch x treatment interaction, planned comparisons of data from each task or epoch were then made between placebo and each of the EGCG treatment groups using t tests calculated with the Mean Squares Error from the ANOVA.||||<0.05
72523892|NCT00981292|144577592|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||ANCOVA|||Task performance data were analysed by within subjects ANCOVA (treatment) with pre-treatment performance included as a co-variate for each individual task/measure.||||>0.05
72523893|NCT00981292|144577593|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||t-test, 2 sided|||Mood data was analysed via student t-test.||||>0.05
72523894|NCT00262639|144577640|SUPERIORITY|||||||0.03|||||||Regression, Logistic|||||||0.03
72523895|NCT00262639|144577641|SUPERIORITY|||||||0.0006||||||This p value is for the interaction of AW status by medication group.|ANOVA|||The analysis was an ANOVA interaction analysis with alcohol withdrawal (AW) group (Low vs. High) by medication group (active versus placebo medication) across the 6 weeks of the medication trial.||||0.0006
72523896|NCT02736929|144577653|SUPERIORITY||Mean Difference (Final Values)|9.8||||0.12|TWO_SIDED|95.0|-2.7|22.3|||Mixed Models Analysis|||This is the analysis of between-group difference in change from baseline to 6-week follow-up||22.3|-2.7|0.12
72523897|NCT02736929|144577654|SUPERIORITY||Mean Difference (Final Values)|0.3||||0.024|TWO_SIDED|95.0|0.1|0.5|||Mixed Models Analysis|||This is the analysis of between-group difference in change from baseline to 6-week follow-up.||0.5|0.1|0.024
72523898|NCT02736929|144577655|SUPERIORITY||Mean Difference (Final Values)|0.3||||0.027|TWO_SIDED|95.0|0.0|0.6|||Mixed Models Analysis|||This is the analysis of between-group difference in change from baseline to 6-week follow-up.||0.6|0.0|0.027
72523899|NCT02736929|144577656|SUPERIORITY||Mean Difference (Final Values)|3.8||||0.024|TWO_SIDED|95.0|0.5|7.1|||Mixed Models Analysis|||This is the analysis of between-group difference in change from baseline to 6-week follow-up.||7.1|0.5|0.024
72523900|NCT02736929|144577657|SUPERIORITY||Mean Difference (Final Values)|-3.9||||0.19|TWO_SIDED|95.0|-9.8|2.0|||Mixed Models Analysis|||This is the analysis of between-group difference in change from baseline to 6-week follow-up.||2.0|-9.8|0.19
72523901|NCT02736929|144577658|SUPERIORITY||Mean Difference (Final Values)|-0.4||||0.31|TWO_SIDED|95.0|-1.3|0.4|||Mixed Models Analysis|||This is the analysis of between-group difference in change from baseline to 6-week follow-up.||0.4|-1.3|0.31
72523902|NCT02736929|144577659|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.86|TWO_SIDED|95.0|-1.8|1.5|||Mixed Models Analysis|||This is the analysis of between-group difference in change from baseline to 6-week follow-up.||1.5|-1.8|0.86
72523903|NCT02736929|144577660|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.77|TWO_SIDED|95.0|-1.7|1.2|||Mixed Models Analysis|||This is the analysis of between-group difference in change from baseline to 6-week follow-up.||1.2|-1.7|0.77
72523904|NCT03342404|144577665|SUPERIORITY||Difference in proportions|77.1|||||TWO_SIDED|95.0|63.4|87.0|||||The difference in proportions (luspatercept - placebo) and 95% CI were estimated from the exact unconditional test|||87.0|63.4|
72523905|NCT03342404|144577665|SUPERIORITY||Risk Difference (RD)|77.1|||||TWO_SIDED|95.0|68.7|85.5|||||The common risk difference (luspatercept - placebo) and 95% CI were estimated from the CMH test stratified by baseline Hb category and baseline NTDT-PRO T/W domain score category|||85.5|68.7|
72523906|NCT03342404|144577666|SUPERIORITY||Mean Difference (Net)|-0.48||||0.0924|TWO_SIDED|95.0|-1.03|0.08|||ANCOVA|||||0.08|-1.03|0.0924
72523907|NCT03342404|144577667|SUPERIORITY||Mean Difference (Net)|1.42|||<|0.0001|TWO_SIDED|95.0|1.16|1.67|||ANCOVA|||||1.67|1.16|< 0.0001
72523908|NCT03342404|144577668|SUPERIORITY||Mean Difference (Net)|68.8|||<|0.0001|TWO_SIDED|95.0|54.3|80.4|||Cochran-Mantel-Haenszel|||||80.4|54.3|< 0.0001
72523909|NCT03342404|144577669|SUPERIORITY||Mean Difference (Net)|1.39||||0.2641|TWO_SIDED|95.0|-1.06|3.83|||ANCOVA|||||3.83|-1.06|0.2641
72523910|NCT03342404|144577670|SUPERIORITY||Mean Difference (Net)|-0.49||||0.0721|TWO_SIDED|95.0|-1.02|0.04|||ANCOVA|||||0.04|-1.02|0.0721
72523911|NCT03342404|144577671|SUPERIORITY||Mean Difference (Net)|1.49|||<|0.0001|TWO_SIDED|95.0|1.2|1.79|||ANCOVA|||||1.79|1.20|< 0.0001
72523912|NCT03342404|144577672|SUPERIORITY||Mean Difference (Net)|2.19||||0.0959|TWO_SIDED|95.0|-0.39|4.78|||ANCOVA|||||4.78|-0.39|0.0959
72523913|NCT03342404|144577673|SUPERIORITY||Mean Difference (Net)|-0.79||||0.051|TWO_SIDED|95.0|-1.58|0.0|||ANCOVA|||||0.00|-1.58|0.0510
72523914|NCT03342404|144577674|SUPERIORITY||Mean Difference (Net)|-1.07||||0.0047|TWO_SIDED|95.0|-1.8|-0.33|||ANCOVA|||||-0.33|-1.80|0.0047
72523915|NCT03342404|144577675|SUPERIORITY||Odds Ratio (OR)|1.8||||0.1359|TWO_SIDED|95.0|0.8|4.0|||Cochran-Mantel-Haenszel|||||4.0|0.8|0.1359
72523916|NCT03342404|144577676|SUPERIORITY||Odds Ratio (OR)|2.3||||0.0657|TWO_SIDED|95.0|0.9|5.4|||Cochran-Mantel-Haenszel|||||5.4|0.9|0.0657
72523917|NCT03342404|144577677|SUPERIORITY||Mean Difference (Net)|1.39||||0.0847|TWO_SIDED|95.0|-0.19|2.96|||Mixed Models Analysis|||Mean change from baseline in SF-36 PCS to Week 24||2.96|-0.19|0.0847
72523918|NCT03342404|144577677|SUPERIORITY||Mean Difference (Net)|1.75||||0.0712|TWO_SIDED|95.0|-0.15|3.65|||Mixed Models Analysis|||Mean change from baseline in SF-36 PCS to Week 48||3.65|-0.15|0.0712
72523919|NCT03342404|144577677|SUPERIORITY||Mean Difference (Net)|1.54||||0.1633|TWO_SIDED|95.0|-0.63|3.72|||Mixed Models Analysis|||Mean change from baseline in SF-36 MCS to Week 24||3.72|-0.63|0.1633
72523920|NCT03342404|144577677|SUPERIORITY||Mean Difference (Net)|2.7||||0.0469|TWO_SIDED|95.0|0.04|5.36|||Mixed Models Analysis|||Mean change from baseline in SF-36 MCS to Week 48||5.36|0.04|0.0469
72523921|NCT03342404|144577678|SUPERIORITY||Mean Difference (Net)|-4.2||||0.4787|TWO_SIDED|95.0|-21.4|13.0|||Cochran-Mantel-Haenszel|||Percentage of participants with improvement of iron overload (LIC/ICT responders) at Week 24||13.0|-21.4|0.4787
72570804|NCT02504671|144670143|OTHER||Mean Difference (Net)|0.69||||0.654|TWO_SIDED|95.0|-2.36|3.74||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 12, General health|||3.74|-2.36|0.654
72570805|NCT02504671|144670143|OTHER||Mean Difference (Net)|2.29||||0.138|TWO_SIDED|95.0|-0.74|5.33||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 12, General health|||5.33|-0.74|0.138
72570806|NCT02504671|144670143|OTHER||Mean Difference (Net)|1.77||||0.516|TWO_SIDED|95.0|-3.62|7.17||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 24, General health|||7.17|-3.62|0.516
72570807|NCT02504671|144670143|OTHER||Mean Difference (Net)|3.35||||0.198|TWO_SIDED|95.0|-1.77|8.46||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 24, General health|||8.46|-1.77|0.198
72570808|NCT02504671|144670143|OTHER||Mean Difference (Net)|-0.15||||0.941|TWO_SIDED|95.0|-4.15|3.84||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 4, Mental health|||3.84|-4.15|0.941
72570809|NCT02504671|144670143|OTHER||Mean Difference (Net)|0.05||||0.979|TWO_SIDED|95.0|-3.94|4.05||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 4, Mental health|||4.05|-3.94|0.979
72625173|NCT01098747|144780078|SUPERIORITY_OR_OTHER||LS mean difference|0.24||||0.01|TWO_SIDED|95.0|0.06|0.42||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||0.25 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS mean from the ANOVA model.||0.42|0.06|0.010
72523922|NCT03342404|144577678|SUPERIORITY||Mean Difference (Net)|-14.6||||0.0827|TWO_SIDED|95.0|-31.5|2.4|||Cochran-Mantel-Haenszel|||Percentage of participants with improvement of iron overload (LIC/ICT responders) at Week 48||2.4|-31.5|0.0827
72523923|NCT03342404|144577679|SUPERIORITY||Mean Difference (Net)|27.14||||0.5949|TWO_SIDED|95.0|-46.77|101.06|||ANCOVA|||Mean change from baseline in serum ferritin at Week 24||101.06|-46.77|0.5949
72523924|NCT03342404|144577679|SUPERIORITY||Mean Difference (Net)|13.46||||0.3454|TWO_SIDED|95.0|-61.01|87.93|||ANCOVA|||Mean change from baseline in serum ferritin at Week 48||87.93|-61.01|0.3454
72523925|NCT03342404|144577680|SUPERIORITY||Mean Difference (Net)|-0.09||||0.6628|TWO_SIDED|95.0|-0.47|0.3|||ANCOVA|||Mean change from baseline in LIC at Week 24||0.30|-0.47|0.6628
72570810|NCT02504671|144670143|OTHER||Mean Difference (Net)|2.4||||0.287|TWO_SIDED|95.0|-2.03|6.84||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 12, Mental health|||6.84|-2.03|0.287
72523926|NCT03342404|144577680|SUPERIORITY||Mean Difference (Net)|0.66||||0.0859|TWO_SIDED|95.0|-0.09|1.42|||ANCOVA|||Mean change from baseline in LIC at Week 48||1.42|-0.09|0.0859
72523927|NCT03342404|144577681|SUPERIORITY||Mean Difference (Net)|22.2||||0.0013|TWO_SIDED|95.0|5.0|38.6|||Cochran-Mantel-Haenszel|||Percentage of participants who were transfusion free over 24 weeks||38.6|5.0|0.0013
72523928|NCT03342404|144577682|SUPERIORITY||Mean Difference (Net)|37.4|||<|0.0001|TWO_SIDED|95.0|20.9|53.0|||Cochran-Mantel-Haenszel|||Percentage of Participants Who are Transfusion-Free Over 48 Weeks||53.0|20.9|< 0.0001
72523929|NCT03342404|144577684|SUPERIORITY||Mean Difference (Net)|16.15||||0.1466|TWO_SIDED|95.0|-5.73|38.04|||ANCOVA|||Mean change from baseline in 6MWT distance at Week 24||38.04|-5.73|0.1466
72570811|NCT02504671|144670143|OTHER||Mean Difference (Net)|3.45||||0.125|TWO_SIDED|95.0|-0.96|7.85||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 12, Mental health|||7.85|-0.96|0.125
72570812|NCT02504671|144670143|OTHER||Mean Difference (Net)|2.15||||0.503|TWO_SIDED|95.0|-4.18|8.49||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 24, Mental health|||8.49|-4.18|0.503
72570813|NCT02504671|144670143|OTHER||Mean Difference (Net)|5.01||||0.099|TWO_SIDED|95.0|-0.96|10.98||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 24,Mental health|||10.98|-0.96|0.099
72570814|NCT02504671|144670143|OTHER||Mean Difference (Net)|1.88||||0.268|TWO_SIDED|95.0|-1.45|5.21||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 4, Physical functioning|||5.21|-1.45|0.268
72570815|NCT02504671|144670143|OTHER||Mean Difference (Net)|2.45||||0.147|TWO_SIDED|95.0|-0.87|5.77||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 4, Physical functioning|||5.77|-0.87|0.147
72570816|NCT02504671|144670143|OTHER||Mean Difference (Net)|2.87||||0.145|TWO_SIDED|95.0|-0.99|6.73||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 12, Physical functioning|||6.73|-0.99|0.145
72570817|NCT02504671|144670143|OTHER||Mean Difference (Net)|2.54||||0.014|TWO_SIDED|95.0|0.97|8.61||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 12, Physical functioning|||8.61|0.97|0.014
72406426|NCT02942017|144321622|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.125||0.9702|TWO_SIDED|95.0|-0.24|0.25|||MMRM|||Retardation, Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.25|-0.24|0.9702
72406427|NCT02942017|144321622|SUPERIORITY||LS Mean Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.114||0.8001|TWO_SIDED|95.0|-0.25|0.2|||MMRM|||Retardation, Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.20|-0.25|0.8001
72406428|NCT02942017|144321622|SUPERIORITY||LS Mean Difference|0.11|STANDARD_ERROR_OF_MEAN|0.109||0.3223|TWO_SIDED|95.0|-0.11|0.32|||MMRM|||Retardation, Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects||0.32|-0.11|0.3223
72406429|NCT02942017|144321622|SUPERIORITY||LS Mean Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.089||0.3385|TWO_SIDED|95.0|-0.26|0.09|||MMRM|||Retardation, Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects||0.09|-0.26|0.3385
72523930|NCT03342404|144577684|SUPERIORITY||Mean Difference (Net)|12.44||||0.2011|TWO_SIDED|95.0|-6.72|31.59|||ANCOVA|||Mean change from baseline in 6MWT distance at Week 48||31.59|-6.72|0.2011
72523931|NCT03342404|144577685|SUPERIORITY||Mean Difference (Net)|52.1|||<|0.0001|TWO_SIDED|95.0|36.2|66.2|||Cochran-Mantel-Haenszel|||Percentage of Participants with an Increase From Baseline ≥1.5 g/dL in Mean Hemoglobin Values in the Absence of Transfusion||66.2|36.2|< 0.0001
72523932|NCT03342404|144577686|SUPERIORITY||Mean Difference (Net)|1.7||||0.1989|TWO_SIDED|95.0|0.8|3.7|||Cochran-Mantel-Haenszel|||Percentage of Participants With a Decrease From Baseline ≥ RD (= 1) in the Non-Transfusion Dependent β-thalassemia-Patient Reported Outcome (NTDT-PRO) Tiredness and Weakness (T/W) Domain Score Week 13 to Week 24||3.7|0.8|0.1989
72523933|NCT03342404|144577686|SUPERIORITY||Mean Difference (Net)|2.1||||0.0733|TWO_SIDED|95.0|0.9|5.0|||Cochran-Mantel-Haenszel|||Percentage of Participants With a Decrease From Baseline ≥ RD (= 1) in the Non-Transfusion Dependent β-thalassemia-Patient Reported Outcome (NTDT-PRO) Tiredness and Weakness (T/W) Domain Score Week 37 to Week 48||5.0|0.9|0.0733
72523934|NCT01690988|144577696|OTHER|Test of independence|Difference in Percentages|0.36|STANDARD_ERROR_OF_MEAN|3.301||0.912|TWO_SIDED|95.0|-6.07|7.38|||Chi-squared||Difference in delirium incidence between placebo control and combined ketamine groups.|The primary analysis was a comparison between the placebo control group and the combined ketamine groups||7.38|-6.07|0.912
72570818|NCT02504671|144670143|OTHER||Mean Difference (Net)|0.47||||0.856|TWO_SIDED|95.0|-4.66|5.61||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 24, Physical functioning|||5.61|-4.66|0.856
72570819|NCT02504671|144670143|OTHER||Mean Difference (Net)|0.65||||0.793|TWO_SIDED|95.0|-4.24|5.55||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 24, Physical functioning|||5.55|-4.24|0.793
72625174|NCT01098747|144780078|SUPERIORITY_OR_OTHER||LS mean difference|1.47|||<|0.001|TWO_SIDED|95.0|1.1|1.84||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||0.5 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95 % CI were calculated based on LS mean from the ANOVA model.||1.84|1.10|<0.001
72406430|NCT02942017|144321622|SUPERIORITY||LS Mean Difference|0.04|STANDARD_ERROR_OF_MEAN|0.1||0.7003|TWO_SIDED|95.0|-0.16|0.24|||MMRM|||Retardation, Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects||0.24|-0.16|0.7003
72406431|NCT02942017|144321622|SUPERIORITY||LS Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.099||0.0311|TWO_SIDED|95.0|-0.41|-0.02|||MMRM|||Retardation, Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects||-0.02|-0.41|0.0311
72523935|NCT01690988|144577697|SUPERIORITY|||||||0.964|||||||ANOVA|one-way||We compared the combined average pain level (pain level at rest, taking a deep breath, and/or when moving) over the entire day (AM and PM).||||0.964
72570820|NCT02504671|144670143|OTHER||Mean Difference (Net)|0.59||||0.778|TWO_SIDED|95.0|-3.51|4.69||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 4, Role emotional|||4.69|-3.51|0.778
72570821|NCT02504671|144670143|OTHER||Mean Difference (Net)|-0.6||||0.773|TWO_SIDED|95.0|-4.7|3.5||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 4, Role emotional|||3.50|-4.70|0.773
72570822|NCT02504671|144670143|OTHER||Mean Difference (Net)|1.08||||0.631|TWO_SIDED|95.0|-3.34|5.49||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 12, Role emotional|||5.49|-3.34|0.631
72570823|NCT02504671|144670143|OTHER||Mean Difference (Net)|2.68||||0.23|TWO_SIDED|95.0|-1.71|7.07||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 12, Role emotional|||7.07|-1.71|0.230
72570824|NCT02504671|144670143|OTHER||Mean Difference (Net)|0.41||||0.901|TWO_SIDED|95.0|-6.03|6.84||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 24, Role emotional|||6.84|-6.03|0.901
72570825|NCT02504671|144670143|OTHER||Mean Difference (Net)|2.52||||0.412|TWO_SIDED|95.0|-3.54|8.59||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 24, Role emotional|||8.59|-3.54|0.412
72570826|NCT02504671|144670143|OTHER||Mean Difference (Net)|1.88||||0.234|TWO_SIDED|95.0|-1.22|4.98||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 4, Role physical|||4.98|-1.22|0.234
72570827|NCT02504671|144670143|OTHER||Mean Difference (Net)|2.66||||0.094|TWO_SIDED|95.0|-0.46|5.77||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 4, Role physical|||5.77|-0.46|0.094
72570828|NCT02504671|144670143|OTHER||Mean Difference (Net)|1.43||||0.423|TWO_SIDED|95.0|-2.08|4.94||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 12, Role physical|||4.94|-2.08|0.423
72570829|NCT02504671|144670143|OTHER||Mean Difference (Net)|3.35||||0.061|TWO_SIDED|95.0|-0.16|6.86||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 12, Role physical|||6.86|-0.16|0.061
72570830|NCT02504671|144670143|OTHER||Mean Difference (Net)|1.21||||0.657|TWO_SIDED|95.0|-4.16|6.57||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 24, Role physical|||6.57|-4.16|0.657
72570831|NCT02504671|144670143|OTHER||Mean Difference (Net)|0.87||||0.737|TWO_SIDED|95.0|-4.22|5.95||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 24, Role physical|||5.95|-4.22|0.737
72570832|NCT02504671|144670143|OTHER||Mean Difference (Net)|2.95||||0.165|TWO_SIDED|95.0|-1.22|7.11||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 4, Social Functioning|||7.11|-1.22|0.165
72570833|NCT02504671|144670143|OTHER||Mean Difference (Net)|3.4||||0.109|TWO_SIDED|95.0|-0.77|7.56||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 4, Social Functioning|||7.56|-0.77|0.109
72570834|NCT02504671|144670143|OTHER||Mean Difference (Net)|1.98||||0.359|TWO_SIDED|95.0|-2.26|6.21||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 12, Social Functioning|||6.21|-2.26|0.359
72570835|NCT02504671|144670143|OTHER||Mean Difference (Net)|4.35||||0.043|TWO_SIDED|95.0|0.14|8.56||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 12, Social Functioning|||8.56|0.14|0.043
72570836|NCT02504671|144670143|OTHER||Mean Difference (Net)|-0.33||||0.923|TWO_SIDED|95.0|-7.15|6.49||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 24, Social Functioning|||6.49|-7.15|0.923
72570837|NCT02504671|144670143|OTHER||Mean Difference (Net)|0.3||||0.927|TWO_SIDED|95.0|-6.11|6.7||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, Social Functioning|||6.70|-6.11|0.927
72570838|NCT02504671|144670143|OTHER||Mean Difference (Net)|4.64||||0.018|TWO_SIDED|95.0|0.82|8.46||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, Vitality|||8.46|0.82|0.018
72570839|NCT02504671|144670143|OTHER||Mean Difference (Net)|3.34||||0.087|TWO_SIDED|95.0|-0.49|7.17||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 4, Vitality|||7.17|-0.49|0.087
72570840|NCT02504671|144670143|OTHER||Mean Difference (Net)|2.64||||0.193|TWO_SIDED|95.0|-1.35|6.64||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 12, Vitality|||6.64|-1.35|0.193
72570841|NCT02504671|144670143|OTHER||Mean Difference (Net)|3.97||||0.051|TWO_SIDED|95.0|-0.01|7.95||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 12, Vitality|||7.95|-0.01|0.051
72570842|NCT02504671|144670143|OTHER||Mean Difference (Net)|3.36||||0.321|TWO_SIDED|95.0|-3.31|10.02||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 24, Vitality|||10.02|-3.31|0.321
72570843|NCT02504671|144670143|OTHER||Mean Difference (Net)|3.13||||0.328|TWO_SIDED|95.0|-3.18|9.44||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, Vitality|||9.44|-3.18|0.328
72570844|NCT02504671|144670144|OTHER||Mean Difference (Net)|-0.65||||0.701|TWO_SIDED|95.0|-3.97|2.67||MMRM analysis adjusted for FACIT Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, FACIT score|||2.67|-3.97|0.701
72570845|NCT02504671|144670144|OTHER||Mean Difference (Net)|1.5||||0.37|TWO_SIDED|95.0|-1.79|4.78||MMRM analysis adjusted for FACIT Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, FACIT score|||4.78|-1.79|0.370
72570846|NCT02504671|144670144|OTHER||Mean Difference (Net)|2.55||||0.125|TWO_SIDED|95.0|-0.71|5.81||MMRM analysis adjusted for FACIT Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, FACIT score|||5.81|-0.71|0.125
72570847|NCT02504671|144670144|OTHER||Mean Difference (Net)|1.92||||0.292|TWO_SIDED|95.0|-1.66|5.5||MMRM analysis adjusted for FACIT Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, FACIT score|||5.50|-1.66|0.292
72570848|NCT02504671|144670144|OTHER||Mean Difference (Net)|6.11||||0.163|TWO_SIDED|95.0|-1.04|6.11||MMRM analysis adjusted for FACIT Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, FACIT sscore|||6.11|-1.04|0.163
72570849|NCT02504671|144670144|OTHER||Mean Difference (Net)|3.08||||0.087|TWO_SIDED|95.0|-0.46|6.61||MMRM analysis adjusted for FACIT Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, FACIT score|||6.61|-0.46|0.087
72625175|NCT01098747|144780078|SUPERIORITY_OR_OTHER||LS mean difference|0.53|||<|0.001|TWO_SIDED|95.0|0.27|0.8||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||0.5 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS mean from the ANOVA model.||0.80|0.27|<0.001
72406432|NCT02942017|144321622|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.079||0.1976|TWO_SIDED|95.0|-0.26|0.06|||MMRM|||Retardation, Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects||0.06|-0.26|0.1976
72570850|NCT02504671|144670144|OTHER||Mean Difference (Net)|0.76||||0.808|TWO_SIDED|95.0|-5.4|6.92||MMRM analysis adjusted for FACIT Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, FACIT score|||6.92|-5.40|0.808
72406433|NCT02942017|144321622|SUPERIORITY||LS Mean Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.092||0.5489|TWO_SIDED|95.0|-0.24|0.13|||MMRM|||Retardation, Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects||0.13|-0.24|0.5489
72570851|NCT02504671|144670144|OTHER||Mean Difference (Net)|-0.47||||0.874|TWO_SIDED|95.0|-6.31|5.38||MMRM analysis adjusted for FACIT Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, FACIT score|||5.38|-6.31|0.874
72625176|NCT01098747|144780078|SUPERIORITY_OR_OTHER||LS mean difference|2.22|||<|0.001|TWO_SIDED|95.0|1.84|2.6||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1 hour: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS mean from the ANOVA model.||2.60|1.84|<0.001
72523936|NCT01690988|144577698|SUPERIORITY|||||||0.476|||||||ANOVA|||"All morphine equivalent drugs consumed by patients perioperatively~Opioid Drugs included:~\* Postoperatively while still in hospital, the list of pain medication used included Morphine, Hydromorphone, Meperidine, Nalbuphine, Oxycodone,Oxymorphone, Tramadol, bupivacaine, (Codeine, Fentanyl, Naloxone) Total Opiates (Morphine Equivalent) in milligrams The median(IQR) opioid consumption was compared across the three study groups Placebo vs. Lo-K (0.5 mg/kg) vs. Hi-K (1 mg/kg)"||||0.476
72523937|NCT01690988|144577699|SUPERIORITY||frequency-test|0.572||||0.572|TWO_SIDED||||||Chi-squared|||"Assessed from patient-reported postoperative nausea and vomiting section of Behavioral Pain Scale or Behavioral Pain Scale (Non-Intubated) Patients where asked whether they currently have nausea/vomiting AM \& PM the response choices: None, Mild, Moderate, Severe Incidence of nausea\\vomiting accounted for any positive reporting(Mild, moderate, or sever) Daily incidence accounted for any positive incidence AM/PM in each POD Any POD nausea/vomiting reports the incidence across day 1-3"||||0.572
72523938|NCT01690988|144577701|SUPERIORITY|||||||0.01|||||||Chi-squared|||Frequency of patients reporting hallucinations using the DSAQ instrument.||||0.01
72523939|NCT01690988|144577702|SUPERIORITY|||||||0.03||||||"Patients where asked whether Following their surgery they had bad dreams or nightmares the response choices: Yes/No question The incidence of hallucination and nightmares were assessed separately and compared across the three study group."|Chi-squared|||||||0.03
72523940|NCT00638274|144577703|OTHER||||||>|0.05|||||||Chi-squared|||||||>.05
72523941|NCT00638274|144577703|OTHER||||||>|0.05|||||||Chi-squared|||||||>.05
72523942|NCT01634100|144577705|NON_INFERIORITY_OR_EQUIVALENCE|Ratio calculated as empa and rifampicin divided by empa|Geometric Mean Ratio|135.2|STANDARD_DEVIATION|7.3|||TWO_SIDED|90.0|129.58|141.06|||ANOVA|Based on an ANOVA including the random effect subjects within sequences and the fixed effects sequence, period and treatment.|Standard deviation is actually the intra-subject coefficient of variation.|||141.06|129.58|
72523943|NCT01634100|144577705|NON_INFERIORITY_OR_EQUIVALENCE|Ratio calculated as empa plus probenecid divided by empa|Geometric Mean Ratio|153.47|STANDARD_DEVIATION|7.4|||TWO_SIDED|90.0|146.41|160.88|||ANOVA|Based on an ANOVA including the random effect subjects within sequences and the fixed effects sequence, period and treatment.|Standard deviation is actually the intra-subject coefficient of variation.|||160.88|146.41|
72523944|NCT01634100|144577706|NON_INFERIORITY_OR_EQUIVALENCE|Ratio calculated as empa and rifampicin divided by empa|Geometric Mean Ratio|175.14|STANDARD_DEVIATION|15.4|||TWO_SIDED|90.0|160.14|191.56|||ANOVA|Based on an ANOVA including the random effect subjects within sequences and the fixed effects sequence, period and treatment.|Standard deviation is actually the intra-subject coefficient of variation.|||191.56|160.14|
72523945|NCT01634100|144577706|NON_INFERIORITY_OR_EQUIVALENCE|Ratio calculated as empa plus probenecid divided by empa|Geometric Mean Ratio|125.6|STANDARD_DEVIATION|15.9|||TWO_SIDED|90.0|113.67|138.78|||ANOVA|Based on an ANOVA including the random effect subjects within sequences and the fixed effects sequence, period and treatment.|Standard deviation is actually the intra-subject coefficient of variation.|||138.78|113.67|
72523946|NCT01634100|144577707|NON_INFERIORITY_OR_EQUIVALENCE|Ratio calculated as empa and rifampicin divided by empa|Geometric Mean Ratio|136.42|STANDARD_DEVIATION|7.5|||TWO_SIDED|90.0|130.61|142.48|||ANOVA|Based on an ANOVA including the random effect subjects within sequences and the fixed effects sequence, period and treatment.|Standard deviation is actually the intra-subject coefficient of variation.|||142.48|130.61|
72570852|NCT02504671|144670144|OTHER||Mean Difference (Net)|-0.81||||0.78|TWO_SIDED|95.0|-6.58|4.95||MMRM analysis adjusted for FACIT Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24,FACIT score|||4.95|-6.58|0.780
72570853|NCT02504671|144670144|OTHER||Mean Difference (Net)|3.57||||0.033|TWO_SIDED|95.0|0.29|6.85||MMRM analysis adjusted for FACIT Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, FACIT score|||6.85|0.29|0.033
72523947|NCT01634100|144577707|NON_INFERIORITY_OR_EQUIVALENCE|Ratio calculated as empa plus probenecid divided by empa|Geometric Mean Ratio|153.61|STANDARD_DEVIATION|7.5|||TWO_SIDED|90.0|146.5|161.06|||ANOVA|Based on an ANOVA including the random effect subjects within sequences and the fixed effects sequence, period and treatment.|Standard deviation is actually the intra-subject coefficient of variation.|||161.06|146.50|
72523948|NCT01975376|144577709|SUPERIORITY||Hazard Ratio (HR)|0.99||||0.930905|TWO_SIDED|95.0|0.8|1.22|||Log Rank|||Hazard ratio and 95 percent (%) Confidence Interval (CI) were from a Cox proportional hazards model stratified by geographic region and low density lipoprotein cholesterol (LDL-C) at pre-screening (less than \[\<\] 100 milligrams per deciliters \[mg/dL\], greater than and equal to \[\>=\] 100 mg/dL) with treatment as a co-variate.||1.22|0.80|0.930905
72625177|NCT01098747|144780078|SUPERIORITY_OR_OTHER||LS mean difference|0.39||||0.006|TWO_SIDED|95.0|0.12|0.66||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1 hour: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS mean from the ANOVA model.||0.66|0.12|0.006
72625178|NCT01098747|144780078|SUPERIORITY_OR_OTHER||LS mean difference|2.39|||<|0.001|TWO_SIDED|95.0|2.0|2.77||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1.5 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS mean from the ANOVA model.||2.77|2.00|<0.001
72625179|NCT01098747|144780078|SUPERIORITY_OR_OTHER||LS mean difference|0.33||||0.022|TWO_SIDED|95.0|0.05|0.6||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1.5 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS mean from the ANOVA model.||0.60|0.05|0.022
72523949|NCT01975376|144577710|SUPERIORITY||Hazard Ratio (HR)|1.03||||0.784265|TWO_SIDED|95.0|0.82|1.3|||Log Rank|||Hazard ratio and 95% CI were from a Cox proportional hazards model stratified by geographic region and LDL-C at pre-screening (\<100 mg/dL, \>=100 mg/dL) with treatment as a covariate.||1.30|0.82|0.784265
72523950|NCT01975376|144577711|SUPERIORITY||Hazard Ratio (HR)|0.99||||0.892441|TWO_SIDED|95.0|0.81|1.2|||Log Rank|||Hazard ratio and 95% CI were from a Cox proportional hazards model stratified by geographic region and LDL-C at pre-screening (\<100 mg/dL, \>=100 mg/dL) with treatment as a covariate.||1.20|0.81|0.892441
72570854|NCT02504671|144670144|OTHER||Mean Difference (Net)|2.81||||0.094|TWO_SIDED|95.0|-0.48|6.1||MMRM analysis adjusted for FACIT Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, FACIT score|||6.10|-0.48|0.094
72570855|NCT02504671|144670144|OTHER||Mean Difference (Net)|3.92||||0.032|TWO_SIDED|95.0|0.34|7.49||MMRM analysis adjusted for FACIT Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, FACIT score|||7.49|0.34|0.032
72523951|NCT01975376|144577712|SUPERIORITY||Hazard Ratio (HR)|1.02||||0.845797|TWO_SIDED|95.0|0.83|1.26|||Log Rank|||Hazard ratio and 95% CI were from a Cox proportional hazards model stratified by geographic region and LDL-C at pre-screening (\<100 mg/dL, \>=100 mg/dL) with treatment as a covariate.||1.26|0.83|0.845797
72523952|NCT01975376|144577713|SUPERIORITY||Hazard Ratio (HR)|0.82||||0.431903|TWO_SIDED|95.0|0.49|1.36|||Log Rank|||Hazard ratio and 95% CI were from a Cox proportional hazards model stratified by geographic region and LDL-C at pre-screening (\<100 mg/dL, \>=100 mg/dL) with treatment as a covariate.||1.36|0.49|0.431903
72523953|NCT01975376|144577714|SUPERIORITY||Hazard Ratio (HR)|0.98||||0.883797|TWO_SIDED|95.0|0.8|1.21|||Log Rank|||Hazard ratio and 95% CI were from a Cox proportional hazards model stratified by geographic region and LDL-C at pre-screening (\<100 mg/dL, \>=100 mg/dL) with treatment as a covariate.||1.21|0.80|0.883797
72523954|NCT01975376|144577715|SUPERIORITY||Hazard Ratio (HR)|1.2||||0.45569|TWO_SIDED|95.0|0.74|1.95|||Log Rank|||Hazard ratio and 95% CI were from a Cox proportional hazards model stratified by geographic region and LDL-C at pre-screening (\<100 mg/dL, \>=100 mg/dL) with treatment as a covariate.||1.95|0.74|0.455690
72523955|NCT01975376|144577716|SUPERIORITY||Hazard Ratio (HR)|1.11||||0.469496|TWO_SIDED|95.0|0.84|1.48|||Log Rank|||Hazard ratio and 95% CI were from a Cox proportional hazards model stratified by geographic region and LDL-C at pre-screening (\<100 mg/dL, \>=100 mg/dL) with treatment as a covariate.||1.48|0.84|0.469496
72570856|NCT02504671|144670144|OTHER||Mean Difference (Net)|5.33||||0.004|TWO_SIDED|95.0|1.77|8.89||MMRM analysis adjusted for FACIT Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, FACIT score|||8.89|1.77|0.004
72570857|NCT02504671|144670144|OTHER||Mean Difference (Net)|0.73||||0.808|TWO_SIDED|95.0|-5.19|6.64||MMRM analysis adjusted for FACIT Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, FACIT score|||6.64|-5.19|0.808
72523956|NCT01975376|144577717|SUPERIORITY||Hazard Ratio (HR)|1.54||||0.633022|TWO_SIDED|95.0|0.26|9.23|||Log Rank|||Hazard ratio and 95% CI were from a Cox proportional hazards model stratified by geographic region and LDL-C at pre-screening (\<100 mg/dL, \>=100 mg/dL) with treatment as a covariate.||9.23|0.26|0.633022
72523957|NCT01975376|144577718|SUPERIORITY||Hazard Ratio (HR)|1.11||||0.46765|TWO_SIDED|95.0|0.83|1.48|||Log Rank|||Hazard ratio and 95% CI were from a Cox proportional hazards model stratified by geographic region and LDL-C at pre-screening (\<100 mg/dL, \>=100 mg/dL) with treatment as a covariate.||1.48|0.83|0.467650
72570858|NCT02504671|144670144|OTHER||Mean Difference (Net)|1.87||||0.511|TWO_SIDED|95.0|-3.74|7.48||MMRM analysis adjusted for FACIT Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, FACIT score|||7.48|-3.74|0.511
72570859|NCT02504671|144670145|OTHER||Mean Difference (Net)|-0.07||||0.888|TWO_SIDED|95.0|-1.04|0.9||MMRM analysis adjusted for BFI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, BFI score|||0.90|-1.04|0.888
72570860|NCT02504671|144670145|OTHER||Mean Difference (Net)|-0.5||||0.307|TWO_SIDED|95.0|-1.46|0.46||MMRM analysis adjusted for BFI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, BFI score|||0.46|-1.46|0.307
72570861|NCT02504671|144670145|OTHER||Mean Difference (Net)|-0.99||||0.041|TWO_SIDED|95.0|-1.95|-0.04||MMRM analysis adjusted for BFI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, BFI score|||-0.04|-1.95|0.041
72570862|NCT02504671|144670145|OTHER||Mean Difference (Net)|-0.64||||0.191|TWO_SIDED|95.0|-1.6|0.32||MMRM analysis adjusted for BFI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, BFI score|||0.32|-1.60|0.191
72570863|NCT02504671|144670145|OTHER||Mean Difference (Net)|-1.2||||0.014|TWO_SIDED|95.0|-2.16|-0.24||MMRM analysis adjusted for BFI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, BFI score|||-0.24|-2.16|0.014
72570864|NCT02504671|144670145|OTHER||Mean Difference (Net)|-1.39||||0.004|TWO_SIDED|95.0|-2.34|-0.45||MMRM analysis adjusted for BFI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, BFI score|||-0.45|-2.34|0.004
72570865|NCT02504671|144670145|OTHER||Mean Difference (Net)|-0.36||||0.656|TWO_SIDED|95.0|-1.94|1.23||MMRM analysis adjusted for BFI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, BFI score|||1.23|-1.94|0.656
72570866|NCT02504671|144670145|OTHER||Mean Difference (Net)|0.07||||0.928|TWO_SIDED|95.0|-1.43|1.57||MMRM analysis adjusted for BFI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, BFI score|||1.57|-1.43|0.928
72570867|NCT02504671|144670145|OTHER||Mean Difference (Net)|-0.2||||0.788|TWO_SIDED|95.0|-1.68|1.28||MMRM analysis adjusted for BFI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, BFI score|||1.28|-1.68|0.788
72570868|NCT02504671|144670145|OTHER||Mean Difference (Net)|-1.26||||0.01|TWO_SIDED|95.0|-2.22|-0.3||MMRM analysis adjusted for BFI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, BFI score|||-0.30|-2.22|0.010
72570869|NCT02504671|144670145|OTHER||Mean Difference (Net)|-0.93||||0.059|TWO_SIDED|95.0|-1.89|0.03||MMRM analysis adjusted for BFI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, BFI score|||0.03|-1.89|0.059
72570870|NCT02504671|144670145|OTHER||Mean Difference (Net)|-1.44||||0.003|TWO_SIDED|95.0|-2.4|-0.48||MMRM analysis adjusted for BFI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, BFI score|||-0.48|-2.40|0.003
72523958|NCT01975376|144577719|SUPERIORITY||Hazard Ratio (HR)|0.53||||0.015462|TWO_SIDED|95.0|0.32|0.89|||Log Rank|||Hazard ratio and 95% CI were from a Cox proportional hazards model stratified by geographic region and LDL-C at pre-screening (\<100 mg/dL, \>=100 mg/dL) with treatment as a covariate.||0.89|0.32|0.015462
72406434|NCT02942017|144321622|SUPERIORITY||LS Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.075||0.7992|TWO_SIDED|95.0|-0.17|0.13|||MMRM|||Retardation, Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects||0.13|-0.17|0.7992
72406435|NCT02942017|144321622|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.103||0.0573|TWO_SIDED|95.0|-0.4|0.01|||MMRM|||Agitation, Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.01|-0.40|0.0573
72523959|NCT01975376|144577720|SUPERIORITY||Hazard Ratio (HR)|0.54||||0.011863|TWO_SIDED|95.0|0.33|0.88|||Log Rank|||Hazard ratio and 95% CI were from a Cox proportional hazards model stratified by geographic region and LDL-C at pre-screening (\<100 mg/dL, \>=100 mg/dL) with treatment as a covariate.||0.88|0.33|0.011863
72523960|NCT01975376|144577721|SUPERIORITY||Hazard Ratio (HR)|0.5||||0.316066|TWO_SIDED|95.0|0.12|2.0|||Log Rank|||Hazard ratio and 95% CI were from a Cox proportional hazards model stratified by geographic region and LDL-C at pre-screening (\<100 mg/dL, \>=100 mg/dL) with treatment as a covariate.||2.00|0.12|0.316066
72523961|NCT01975376|144577722|SUPERIORITY||Hazard Ratio (HR)|0.52||||0.020328|TWO_SIDED|95.0|0.3|0.91|||Log Rank|||Hazard ratio and 95% CI were from a Cox proportional hazards model stratified by geographic region and LDL-C at pre-screening (\<100 mg/dL, \>=100 mg/dL) with treatment as a covariate.||0.91|0.30|0.020328
72523962|NCT01975376|144577723|SUPERIORITY||Hazard Ratio (HR)|0.82||||0.367069|TWO_SIDED|95.0|0.53|1.27|||Log Rank|||Hazard ratio and 95% CI were from a Cox proportional hazards model stratified by geographic region and LDL-C at pre-screening (\<100 mg/dL, \>=100 mg/dL) with treatment as a covariate.||1.27|0.53|0.367069
72523963|NCT01975376|144577724|SUPERIORITY||Hazard Ratio (HR)|0.85||||0.443081|TWO_SIDED|95.0|0.56|1.29|||Log Rank|||Hazard ratio and 95% CI were from a Cox proportional hazards model stratified by geographic region and LDL-C at pre-screening (\<100 mg/dL, \>=100 mg/dL) with treatment as a covariate.||1.29|0.56|0.443081
72523964|NCT01975376|144577725|SUPERIORITY||Hazard Ratio (HR)|0.9||||0.343817|TWO_SIDED|95.0|0.71|1.12|||Log Rank|||Hazard ratio and 95% CI were from a Cox proportional hazards model stratified by geographic region and LDL-C at pre-screening (\<100 mg/dL, \>=100 mg/dL) with treatment as a covariate.||1.12|0.71|0.343817
72523965|NCT01975376|144577726|SUPERIORITY||Hazard Ratio (HR)|1.04||||0.889065|TWO_SIDED|95.0|0.59|1.85|||Log Rank|||Hazard ratio and 95% CI were from a Cox proportional hazards model stratified by geographic region and LDL-C at pre-screening (\<100 mg/dL, \>=100 mg/dL) with treatment as a covariate.||1.85|0.59|0.889065
72523966|NCT01975376|144577727|SUPERIORITY||Hazard Ratio (HR)|0.88||||0.308388|TWO_SIDED|95.0|0.69|1.13|||Log Rank|||Hazard ratio and 95% CI were from a Cox proportional hazards model stratified by geographic region and LDL-C at pre-screening (\<100 mg/dL, \>=100 mg/dL) with treatment as a covariate.||1.13|0.69|0.308388
72523967|NCT01975376|144577728|SUPERIORITY||Hazard Ratio (HR)|1.03||||0.874835|TWO_SIDED|95.0|0.74|1.42|||Log Rank|||Hazard ratio and 95% CI were from a Cox proportional hazards model stratified by geographic region and LDL-C at pre-screening (\<100 mg/dL, \>=100 mg/dL) with treatment as a covariate.||1.42|0.74|0.874835
72523968|NCT01975376|144577729|SUPERIORITY||Hazard Ratio (HR)|1.12||||0.526269|TWO_SIDED|95.0|0.79|1.6|||Log Rank|||Hazard ratio and 95% CI were from a Cox proportional hazards model stratified by geographic region and LDL-C at pre-screening (\<100 mg/dL, \>=100 mg/dL) with treatment as a covariate.||1.60|0.79|0.526269
72523969|NCT01975376|144577730|SUPERIORITY||LS-mean difference|-60.57|||<|0.001|TWO_SIDED|95.0|-61.43|-59.71|||Mixed Effect Model Repeat Measurement|||Lease Square (LS)- mean differences, associated 95% CI, and p-values were from a mixed model repeated measures (MMRM) model including observations through Week 70 with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographic region and LDL-C at pre-screening (\<100 mg/dL, \>=100 mg/dL).||-59.71|-61.43|<0.001
72523970|NCT01975376|144577731|SUPERIORITY||LS-mean difference|-54.7|||<|0.001|TWO_SIDED|95.0|-55.48|-53.92|||Mixed Effect Model Repeat Measurement|||LS- mean differences and associated 95% CI, and p-values were from an MMRM model including observations through Week 70 with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographic region and LDL-C at pre-screening (\<100 mg/dL, \>=100 mg/dL).||-53.92|-55.48|<0.001
72523971|NCT01975376|144577732|SUPERIORITY||LS-mean difference|-46.72|||<|0.001|TWO_SIDED|95.0|-47.68|-45.76|||ANCOVA|||LS- mean difference and associated 95% CI, and p-value were from an analysis of covariance (ANCOVA) model with fixed effects for treatment group, baseline value, geographic region and LDL-C at pre-screening (\<100 mg/dL, \>=100 mg/dL).||-45.76|-47.68|<0.001
72523972|NCT01975376|144577733|SUPERIORITY||LS-mean difference|-54.88|||<|0.001|TWO_SIDED|95.0|-55.66|-54.09|||Mixed Effect Model Repeat Measurement|||Non-HDL-C: LS- mean differences, associated 95% CI, and p-values were from an MMRM model including observations through Week 70 with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographic region and LDL-C at pre-screening (\<100 mg/dL, \>=100 mg/dL).||-54.09|-55.66|<0.001
72523973|NCT01975376|144577733|SUPERIORITY||LS-mean difference|-36.51|||<|0.001|TWO_SIDED|95.0|-37.07|-35.95|||Mixed Effect Model Repeat Measurement|||Total cholesterol: LS- mean differences, associated 95% CI, and p-values were from an MMRM model including observations through Week 70 with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographic region and LDL-C at pre-screening (\<100 mg/dL, \>=100 mg/dL).||-35.95|-37.07|<0.001
72570871|NCT02504671|144670145|OTHER||Mean Difference (Net)|-1.57||||0.001|TWO_SIDED|95.0|-2.53|-0.62||MMRM analysis adjusted for BFI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, BFI score|||-0.62|-2.53|0.001
72570872|NCT02504671|144670145|OTHER||Mean Difference (Net)|-0.76||||0.324|TWO_SIDED|95.0|-2.28|0.76||MMRM analysis adjusted for BFI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, BFI score|||0.76|-2.28|0.324
72570873|NCT02504671|144670145|OTHER||Mean Difference (Net)|-0.58||||0.432|TWO_SIDED|95.0|-2.02|0.87||MMRM analysis adjusted for BFI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, BFI score|||0.87|-2.02|0.432
72570874|NCT01951885|144670161|SUPERIORITY|||||||0.05|||||||Wilcoxon (Mann-Whitney)|47 patients per arm were needed to detect a 25% improvement in mucositis based on a one-sided test with 5% significance and 80% power.||||||0.05
72570875|NCT01951885|144670164|NON_INFERIORITY|Cumulative incidence methods are compared using the Gray test with a p-value \<0.05|||||<|0.05|||||||Log Rank|||||||<0.05
72523974|NCT01975376|144577733|SUPERIORITY||LS-mean difference|-20.17|||<|0.001|TWO_SIDED|95.0|-21.42|-18.93|||Mixed Effect Model Repeat Measurement|||VLDL-C: LS- mean differences, associated 95% CI, and p-values were from an MMRM model including observations through Week 70 with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographic region and LDL-C at pre-screening (\<100 mg/dL, \>=100 mg/dL).||-18.93|-21.42|<0.001
72523975|NCT01975376|144577733|SUPERIORITY||LS-Mean Difference|-30.25|||<|0.001|TWO_SIDED|95.0|-32.44|-28.07|||Mixed Effect Model Repeat Measurement|||RLP-C: LS- mean differences, associated 95% CI, and p-values were from an MMRM model including observations through Week 70 with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographic region and LDL-C at pre-screening (\<100 mg/dL, \>=100 mg/dL).||-28.07|-32.44|<0.001
72523976|NCT01975376|144577733|SUPERIORITY||LS-Mean Difference|-58.55|||<|0.001|TWO_SIDED|95.0|-59.42|-57.69|||Mixed Effect Model Repeat Measurement|||Apo B: LS -mean differences, associated 95% CI, and p-values were from an MMRM model including observations through Week 52 with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographic region and LDL-C at pre-screening (\<100 mg/dL, \>=100 mg/dL).||-57.69|-59.42|<0.001
72523977|NCT01975376|144577733|SUPERIORITY||LS-Mean Difference|6.14|||<|0.001|TWO_SIDED|95.0|5.69|6.59|||Mixed Effect Model Repeat Measurement|||HDL-C: LS- mean differences, associated 95% CI, and p-values were from an MMRM model including observations through Week 70 with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographic region and LDL-C at pre-screening (\<100 mg/dL, \>=100 mg/dL).||6.59|5.69|<0.001
72406436|NCT02942017|144321622|SUPERIORITY||LS Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.11||0.0431|TWO_SIDED|95.0|-0.44|-0.01|||MMRM|||Agitation, Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.01|-0.44|0.0431
72523978|NCT01975376|144577733|SUPERIORITY||LS-Mean Difference|3.53|||<|0.001|TWO_SIDED|95.0|3.02|4.03|||Mixed Effect Model Repeat Measurement|||Apo A-I: LS- mean differences, associated 95% CI, and p-values were from an MMRM model including observations through Week 52 with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographic region and LDL-C at pre-screening (\<100 mg/dL, \>=100 mg/dL).||4.03|3.02|<0.001
72523979|NCT01975376|144577734|SUPERIORITY||LS-mean difference|0.67|||<|0.001|TWO_SIDED|95.0|0.66|0.68|||Mixed Effect Model Repeat Measurement|||Lp (a): LS- mean differences and associated 95% CI, and p-values were from an MMRM model on the difference of log-transformed observations through Week 52 with fixed effects for treatment group, visit, treatment group\*visit interaction, log-transformed baseline value, log-transformed baseline value\*visit interaction, geographical region and LDL-C at pre-screening (\<100 mg/dL, \>=100 mg/dL).||0.68|0.66|<0.001
72570876|NCT01951885|144670165|NON_INFERIORITY|Hospital stay will be compared between groups using the Wilcoxon rank sum test with a p value of 0.05.||||||0.05|||||||Wilcoxon (Mann-Whitney)|||||||0.05
72570877|NCT01951885|144670166|NON_INFERIORITY|TPN use will be compared using the Chi-square test.|||||<|0.05|||||||Chi-squared|||||||<0.05
72570878|NCT01951885|144670167|NON_INFERIORITY|Overall survival was estimated using the Kaplan-Meier method and compared between patients receiving Tac/MTX versus Tac/mini-MTX/MMF using the log-rank test|||||<|0.05|||||||Log Rank|||||||<0.05
72570879|NCT01951885|144670168|NON_INFERIORITY|Progression-free survival was estimated using the Kaplan-Meier method and compared between patients receiving Tac/MTX versus Tac/mini-MTX/MMF using the log-rank test|||||<|0.05|||||||Log Rank|||||||<0.05
72570880|NCT01951885|144670171|NON_INFERIORITY|Infusion times will be compared using the Wilcoxon rank sum test|||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
72570881|NCT01951885|144670172|NON_INFERIORITY|100-day incidence of complications will be compared using the Gray test.|||||<|0.05|||||||Gray Test|||||||<0.05
72570882|NCT01951885|144670173|NON_INFERIORITY|100-day incidence of complications will be compared using the Gray test.|||||<|0.05|||||||Gray Test|||||||<0.05
72570883|NCT01951885|144670174|NON_INFERIORITY|100-day incidence of complications will be compared using the Gray test.|||||<|0.05|||||||Chi-squared|||||||<0.05
72570884|NCT01951885|144670175|NON_INFERIORITY|100-day incidence of complications will be compared using the Gray test.|||||<|0.05|||||||Gray Test|||||||<0.05
72570885|NCT01951885|144670177|NON_INFERIORITY|180-day incidence of complications will be compared using the Gray test.|||||<|0.05|||||||Gray Test|||||||<0.05
72570886|NCT01951885|144670178|NON_INFERIORITY|180-day incidence of complications will be compared using the Gray test.|||||<|0.05|||||||Gray Test|||||||<0.05
72570887|NCT01951885|144670179|NON_INFERIORITY|180-day incidence of complications will be compared using the Gray test.|||||<|0.05|||||||Gray Test|||||||<0.05
72570888|NCT00866658|144670182|SUPERIORITY_OR_OTHER||Least squares (LS) mean difference|-0.88|STANDARD_ERROR_OF_MEAN|0.118|<|0.0001|TWO_SIDED|95.0|-1.116|-0.65||Statistical testing: 2-sided at significance level=0.05. Analysis of co-variance(ANCOVA)included treatment arms, randomization strata of screening HbA1c (\<8.0, \>=8.0%),sulfonylurea use (yes, no), country as fixed effects, baseline HbA1c as covariate.|ANCOVA|||To detect a difference of 0.5% in change from baseline to Week 24 in HbA1c between lixisenatide and placebo, 145 patients in each arm would provide a power of 90% assuming common standard deviation of 1.3% with a 2-sided t test at 5% significance level.||-0.650|-1.116|<0.0001
72625180|NCT01098747|144780078|SUPERIORITY_OR_OTHER||LS mean difference|2.39|||<|0.001|TWO_SIDED|95.0|2.0|2.79||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||2 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS mean from the ANOVA model.||2.79|2.00|<0.001
72625181|NCT01098747|144780078|SUPERIORITY_OR_OTHER||LS mean difference|0.13||||0.369|TWO_SIDED|95.0|-0.15|0.41||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||2 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS mean from the ANOVA model.||0.41|-0.15|0.369
72406437|NCT02942017|144321622|SUPERIORITY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.108||0.006|TWO_SIDED|95.0|-0.52|-0.09|||MMRM|||Agitation, Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.09|-0.52|0.0060
72406438|NCT02942017|144321622|SUPERIORITY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.127||0.0215|TWO_SIDED|95.0|-0.55|-0.04|||MMRM|||Agitation, Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.04|-0.55|0.0215
72523980|NCT01975376|144577734|SUPERIORITY||LS-mean difference|0.81|||<|0.001|TWO_SIDED|95.0|0.8|0.81|||Mixed Effect Model Repeat Measurement|||Triglycerides: LS- mean differences and associated 95% CI, and p-values were from an MMRM model through Week 70 on the difference of log-transformed observations with fixed effects for treatment group, visit, treatment group\*visit interaction, log-transformed baseline value, log-transformed baseline value\*visit interaction, geographical region and LDL-C at pre-screening (\<100 mg/dL, \>=100 mg/dL).||0.81|0.80|<0.001
72523981|NCT01975376|144577735|SUPERIORITY||LS-mean difference|1.06|||<|0.001|TWO_SIDED|95.0|1.03|1.1|||Mixed Effect Model Repeat Measurement|||LS- mean differences and associated 95% CI, and p-values were from an MMRM model on the difference of log-transformed observations through Week 52 with fixed effects for treatment group, visit, treatment group\*visit interaction, log-transformed baseline value, log-transformed baseline value\*visit interaction, geographical region and LDL-C at pre-screening (\<100 mg/dL, \>=100 mg/dL).||1.10|1.03|<0.001
72523982|NCT03054740|144577740|SUPERIORITY||||||||||||||||||Levene's Test of Equality of Error Variances (Design: Intercept + Pain Previous IV + Intervention) F = .001, df1 = 1, df2=28, Sig. = .972|||
72523983|NCT03054740|144577741|SUPERIORITY|||||||0.39|||||||Fisher Exact|||||||.390
72523984|NCT01378299|144577749|OTHER||||||<|0.05|||||||ANOVA|||Analysis by intention to treat with last value carry forward.||||<0.05
72523985|NCT01378299|144577750|OTHER||||||<|0.05|||||||ANOVA|||Analysis by intention to treat with the last value carry forward||||<0.05
72523986|NCT01378299|144577751|OTHER||||||<|0.05|||||||ANOVA|||Analysis by intention to treat with the last value carry forward.||||<0.05
72625182|NCT01098747|144780078|SUPERIORITY_OR_OTHER||LS mean difference|2.19|||<|0.001|TWO_SIDED|95.0|1.78|2.6||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||3 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS mean from the ANOVA model.||2.60|1.78|<0.001
72523987|NCT01378299|144577752|OTHER||||||<|0.05|||||||ANOVA|||Analysis by intention to treat with the last value carry forward.||||<0.05
72523988|NCT01378299|144577753|OTHER||||||<|0.05|||||||ANOVA|||Analysis by intention to treat with the last value carry forward.||||<0.05
72523989|NCT01378299|144577754|OTHER||||||<|0.05|||||||ANOVA|||Analysis by intention to treat with the last value carry forward.||||<0.05
72523990|NCT01378299|144577755|OTHER||||||<|0.05|||||||ANOVA|||Analysis by intention to treat with the last value carry forward.||||<0.05
72523991|NCT01378299|144577757|OTHER||||||<|0.05|||||||ANOVA|||Analysis was by intention to treat with the last value carry forward. Those who had at least one follow-up from baseline and with acceptable assay coefficient of variability were included in the analysis. The data of 79 subjects were analyzed; 15 in the GG, 43 in the GA and 21 in the AA genotype.||||<0.05
72523992|NCT01378299|144577758|OTHER||||||<|0.05|||||||ANOVA|||Analysis by intention to treat with the last value carry forward.||||<0.05
72523993|NCT01378299|144577759|OTHER||||||<|0.05|||||||ANOVA|||Analysis by intention to treat with the last value carry forward.||||<0.05
72523994|NCT01378299|144577760|OTHER||||||<|0.05|||||||ANOVA|||Analysis by intention to treat with the last value carry forward.||||<0.05
72523995|NCT01448707|144577774|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority of DRV/rtv monotherapy versus triple therapy was assessed with a maximum allowable difference of 12 percent (%), with a one-sided significance level of 2.5%.|Non-Linear mixed|-7.9||||0.2331|TWO_SIDED|95.0|-14.64|-1.19||P-Value for non-inferiority of DRV/rtv MONO vs DRV/rtv + 2NRTIs (delta = 12%).|Mixed Models Analysis|Predicted response rate:confidence limits are obtained by means of logistic regression model with treatment group and Hepatitis C status as covariates||||-1.19|-14.64|0.2331
72523996|NCT01448707|144577775|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority of DRV/rtv monotherapy versus triple therapy was assessed with a maximum allowable difference of 12 percent (%), with a one-sided significance level of 2.5% and 80% power.|Non-Linear mixed|-10.1||||0.6933|TWO_SIDED|95.0|-19.5|-0.73|||Mixed Models Analysis|||||-0.73|-19.50|0.6933
72523997|NCT01448707|144577776|NON_INFERIORITY_OR_EQUIVALENCE|Week 48: Non-inferiority of DRV/rtv monotherapy versus triple therapy was assessed with a maximum allowable difference of 12 percent (%), with a one-sided significance level of 2.5% and 80% power.|Non-linear mixed model|-3.5||||0.0016|TWO_SIDED|95.0|-8.77|1.72|||Mixed Models Analysis|||||1.72|-8.77|0.0016
72523998|NCT01448707|144577776|NON_INFERIORITY_OR_EQUIVALENCE|Week 96: Non-inferiority of DRV/rtv monotherapy versus triple therapy was assessed with a maximum allowable difference of 12 percent (%), with a one-sided significance level of 2.5% and 80% power.|non-linear mixed model|-0.7||||0.0022|TWO_SIDED|95.0|-7.89|6.58|||Mixed Models Analysis|||||6.58|-7.89|0.0022
72523999|NCT02512276|144577841|SUPERIORITY||Mean Difference (Net)|4.7|||||TWO_SIDED|95.0|3.0|6.4||||||||6.4|3.0|
72406439|NCT02942017|144321622|SUPERIORITY||LS Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.109||0.0422|TWO_SIDED|95.0|-0.44|-0.01|||MMRM|||Agitation, Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.01|-0.44|0.0422
72524000|NCT02512276|144577842|SUPERIORITY||Odds Ratio (OR)|1.05|||||TWO_SIDED|95.0|0.91|1.22||||||||1.22|0.91|
72524001|NCT02512276|144577843|SUPERIORITY||Odds Ratio (OR)|1.1|||||TWO_SIDED|95.0|0.94|1.28||||||||1.28|0.94|
72524002|NCT02512276|144577844|SUPERIORITY||Odds Ratio (OR)|0.62|||||TWO_SIDED|95.0|0.45|0.85||||||||0.85|0.45|
72524003|NCT02512276|144577845|SUPERIORITY||Odds Ratio (OR)|1.11|||||TWO_SIDED|95.0|0.91|1.36||||||||1.36|0.91|
72524004|NCT02512276|144577846|SUPERIORITY||Odds Ratio (OR)|1.02|||||TWO_SIDED|95.0|0.78|1.34||||||||1.34|0.78|
72524005|NCT04498468|144577894|SUPERIORITY||Mean Difference (Final Values)|-0.55||||0.003|TWO_SIDED|95.0|-0.91|-0.19|||t-test, 2 sided|||Corneal staining analysis, day 28.||-0.19|-0.91|0.003
72524006|NCT04498468|144577894|SUPERIORITY||Mean Difference (Final Values)|-0.5||||0.19|TWO_SIDED|95.0|-1.28|0.28|||t-test, 2 sided|||Corneal staining sub-group analysis, day 28, 18-59 year old subgroup.||0.28|-1.28|0.19
72524007|NCT04498468|144577894|SUPERIORITY||Mean Difference (Final Values)|-0.94||||0.047|TWO_SIDED|95.0|-1.86|-0.02|||t-test, 2 sided|||Corneal staining sub-group analysis, day 28, 60+ year old subgroup.||-0.02|-1.86|0.047
72524008|NCT04498468|144577894|SUPERIORITY||Mean Difference (Final Values)|-0.69||||0.08|TWO_SIDED|95.0|-1.49|0.1|||t-test, 2 sided|||Corneal staining sub-group analysis, day 28, Sjogren's subgroup.||0.10|-1.49|0.08
72524009|NCT04498468|144577894|SUPERIORITY||Mean Difference (Final Values)|-0.77||||0.09|TWO_SIDED|95.0|-1.67|0.14|||t-test, 2 sided|||Corneal staining sub-group analysis, day 28, non-Sjogren's subgroup.||0.14|-1.67|0.09
72524010|NCT04498468|144577894|SUPERIORITY||Mean Difference (Final Values)|-0.68|||<|0.001|TWO_SIDED|95.0|-1.05|-0.3|||t-test, 2 sided|||Conjunctival staining analysis, day 28||-0.30|-1.05|< 0.001
72524011|NCT04498468|144577894|SUPERIORITY||Mean Difference (Final Values)|-0.21||||0.58|TWO_SIDED|95.0|-1.04|0.61|||t-test, 2 sided|||Conjunctival staining sub-group analysis, day 28, 18-59 year old subgroup.||0.61|-1.04|0.58
72524012|NCT04498468|144577894|SUPERIORITY||Mean Difference (Final Values)|-1.19||||0.021|TWO_SIDED|95.0|-2.17|-0.21|||t-test, 2 sided|||Conjunctival staining sub-group analysis, day 28, 60+ year old subgroup.||-0.21|-2.17|0.021
72524013|NCT04498468|144577894|SUPERIORITY||Mean Difference (Final Values)|-0.77||||0.16|TWO_SIDED|95.0|-1.88|0.34|||t-test, 2 sided|||Conjunctival staining sub-group analysis, day 28, Sjogren's subgroup.||0.34|-1.88|0.16
72524014|NCT04498468|144577894|SUPERIORITY||Mean Difference (Final Values)|-0.71||||0.097|TWO_SIDED|95.0|-1.55|0.14|||t-test, 2 sided|||Conjunctival staining sub-group analysis, day 28, non-Sjogren's subgroup.||0.14|-1.55|0.097
72524015|NCT04498468|144577895|SUPERIORITY||Mean Difference (Final Values)|-5.5||||0.069|TWO_SIDED|95.0|-11.4|0.4|||t-test, 2 sided|||Eye dryness, day 28||0.4|-11.4|0.069
72524016|NCT04498468|144577895|SUPERIORITY||Mean Difference (Final Values)|-0.3||||0.92|TWO_SIDED|95.0|-7.0|6.3|||t-test, 2 sided|||VAS Eye discomfort, Day 28||6.3|-7.0|0.92
72524017|NCT04498468|144577895|SUPERIORITY||Mean Difference (Final Values)|-1.3||||0.55|TWO_SIDED|95.0|-5.8|3.1|||t-test, 2 sided|||VAS eye fatigue, day 28||3.1|-5.8|0.55
72524018|NCT04498468|144577896|SUPERIORITY||Risk Ratio (RR)|1.26||||0.42|TWO_SIDED|95.0|0.8|2.0|||McNemar|||||2.0|0.8|0.42
72524019|NCT04498468|144577897|SUPERIORITY||Risk Ratio (RR)|1.04||||1|TWO_SIDED|95.0|0.76|1.42|||McNemar|||||1.42|0.76|1.00
72524020|NCT02725268|144577899|SUPERIORITY||Hazard Ratio (HR)|0.8|||=|0.178|TWO_SIDED|95.0|0.58|1.12||The p-value was obtained using stratified log-rank test with histological subtype, lines of prior chemotherapy and prior taxane therapy (original stratification values).|Stratified Log-rank Test||The hazard ratio was obtained using a stratified Cox proportional hazard model adjusted for histological subtype, lines of prior chemotherapy and prior taxane therapy. A hazard ratio of \<1 was considered statistically significant.|||1.12|0.58|=0.178
72524021|NCT02725268|144577899|SUPERIORITY||Hazard Ratio (HR)|1.85|||=|0.092|TWO_SIDED|95.0|1.19|2.86||The p-value was obtained using stratified log-rank test with histological subtype, lines of prior chemotherapy and prior taxane therapy (original stratification values).|Stratified Log-rank Test||The hazard ratio was obtained using a stratified Cox proportional hazard model adjusted for histological subtype, lines of prior chemotherapy and prior taxane therapy. A hazard ratio of \<1 was considered statistically significant.|||2.86|1.19|=0.092
72524022|NCT02725268|144577899|SUPERIORITY||Hazard Ratio (HR)|2.57|||=|0.147|TWO_SIDED|95.0|1.47|4.49||The p-value was obtained using stratified log-rank test with histological subtype, lines of prior chemotherapy and prior taxane therapy (original stratification values).|Stratified Log-rank Test||The hazard ratio was obtained using a stratified Cox proportional hazard model adjusted for histological subtype, lines of prior chemotherapy and prior taxane therapy. A hazard ratio of \<1 was considered statistically significant.|||4.49|1.47|=0.147
72524023|NCT02725268|144577901|SUPERIORITY||Hazard Ratio (HR)|1.04|||=|0.968|TWO_SIDED|95.0|0.72|1.5||The p-value was obtained using stratified log-rank test with histological subtype, lines of prior chemotherapy and prior taxane therapy (original stratification values).|Stratified Log-rank Test||The hazard ratio was obtained using a stratified Cox proportional hazard model adjusted for histological subtype, lines of prior chemotherapy and prior taxane therapy. A hazard ratio of \<1 was considered statistically significant.|||1.50|0.72|=0.968
72524024|NCT02725268|144577901|SUPERIORITY||Hazard Ratio (HR)|1.5|||=|0.145|TWO_SIDED|95.0|0.95|2.37||The p-value was obtained using stratified log-rank test with histological subtype, lines of prior chemotherapy and prior taxane therapy (original stratification values).|Stratified Log-rank Test||The hazard ratio was obtained using a stratified Cox proportional hazard model adjusted for histological subtype, lines of prior chemotherapy and prior taxane therapy. A hazard ratio of \<1 was considered statistically significant.|||2.37|0.95|=0.145
72524025|NCT02725268|144577901|SUPERIORITY||Hazard Ratio (HR)|1.54|||=|0.243|TWO_SIDED|95.0|0.87|2.73||The p-value was obtained using stratified log-rank test with histological subtype, lines of prior chemotherapy and prior taxane therapy (original stratification values).|Stratified Log-rank Test||The hazard ratio was obtained using a stratified Cox proportional hazard model adjusted for histological subtype, lines of prior chemotherapy and prior taxane therapy. A hazard ratio of \<1 was considered statistically significant.|||2.73|0.87|=0.243
72570889|NCT00609518|144670194|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.09|||||TWO_SIDED|95.0|-0.1|0.28|||Linear probability model|||||0.28|-0.10|
72570890|NCT00609518|144670195|SUPERIORITY_OR_OTHER|||||||0.4902||95.0|||||Fisher Exact|||||||0.4902
72570891|NCT00609518|144670196|SUPERIORITY_OR_OTHER|||||||0.6791||95.0|||||Log Rank|||||||0.6791
72570892|NCT00609518|144670196|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.9|||||TWO_SIDED|95.0|0.54|1.49|||Regression, Cox|Treatment was the covariate included in this model.||||1.49|0.54|
72524026|NCT02725268|144577902|SUPERIORITY||Hazard Ratio (HR)|0.79|||=|0.17|TWO_SIDED|95.0|0.57|1.11||The p-value was obtained using stratified log-rank test with histological subtype, lines of prior chemotherapy and prior taxane therapy (original stratification values).|Stratified Log-rank Test||The hazard ratio was obtained using a stratified Cox proportional hazard model adjusted for histological subtype, lines of prior chemotherapy and prior taxane therapy. A hazard ratio of \<1 was considered statistically significant.|||1.11|0.57|=0.170
72570893|NCT00609518|144670197|SUPERIORITY_OR_OTHER|||||||0.587||95.0|||||Log Rank|||||||0.5870
72570894|NCT00609518|144670197|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.89|||||TWO_SIDED|95.0|0.57|1.38|||Regression, Cox|Treatment was the covariate included in this model.||||1.38|0.57|
72570895|NCT01687478|144670198|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-1.62|||||TWO_SIDED|95.0|-5.04|1.8|||||The Confidence Interval is based on the treatment difference LS Mean changes from baseline between Olanzapine + Fluoxetine and Placebo + Fluoxetine.|||1.80|-5.04|
72570896|NCT00292188|144670208|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.62|STANDARD_ERROR_OF_MEAN|0.24||0.01||95.0|-1.09|-0.15|||ANCOVA|ANCOVA adjusted for treatment group, baseline mean pain score and pooled country||The study is powered to detect a clinically significant difference of 1 between treatment groups in the weekly mean pain score. Null hypothesis was that there was no difference in weekly mean pain scores between pregabalin and placebo.||-0.15|-1.09|0.010
72570897|NCT00292188|144670209|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.84|STANDARD_ERROR_OF_MEAN|0.39||0.031||95.0|-1.6|-0.08|||ANCOVA|ANCOVA adjusted for treatment group, baseline score and pooled country.||||-0.08|-1.60|0.031
72570898|NCT00292188|144670210|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.97|STANDARD_ERROR_OF_MEAN|0.32||0.003||95.0|-1.61|-0.33|||ANCOVA|ANCOVA adjusted for treatment group, baseline score and pooled country.||||-0.33|-1.61|0.003
72570899|NCT00292188|144670211|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.68|STANDARD_ERROR_OF_MEAN|1.0||0.099||95.0|-3.69|0.32|||ANCOVA|ANCOVA adjusted for treatment group, baseline score and pooled country.||||0.32|-3.69|0.099
72570900|NCT00292188|144670212|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.24|STANDARD_ERROR_OF_MEAN|1.03||0.819||95.0|-1.87|2.34|||ANCOVA|ANCOVA adjusted for treatment group, baseline score and pooled country.||||2.34|-1.87|0.819
72570901|NCT00292188|144670213|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.26|STANDARD_ERROR_OF_MEAN|0.15||0.099||95.0|-0.56|0.05|||Mixed Models Analysis|Repeated Measures Mixed Models. Adjusted for treatment, week, baseline pain score, pooled country and treatment-week.||Week 1||0.05|-0.56|0.099
72570902|NCT00292188|144670213|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.26|STANDARD_ERROR_OF_MEAN|0.18||0.15||95.0|-0.62|0.1|||Mixed Models Analysis|Repeated Measures Mixed Models. Adjusted for treatment, week, baseline pain score, pooled country and treatment-week.||Week 2: FAS||0.10|-0.62|0.150
72625183|NCT01098747|144780078|SUPERIORITY_OR_OTHER||LS mean difference|-0.12||||0.42|TWO_SIDED|95.0|-0.42|0.17||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||3 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS mean from the ANOVA model.||0.17|-0.42|0.420
72570903|NCT00292188|144670213|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.53|STANDARD_ERROR_OF_MEAN|0.2||0.01||95.0|-0.93|-0.13|||Mixed Models Analysis|Repeated Measures Mixed Models. Adjusted for treatment, week, baseline pain score, pooled country and treatment-week.||Week 3: FAS||-0.13|-0.93|0.010
72570904|NCT00292188|144670213|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.32|STANDARD_ERROR_OF_MEAN|0.21||0.137||95.0|-0.74|0.1|||Mixed Models Analysis|Repeated Measures Mixed Models. Adjusted for treatment, week, baseline pain score, pooled country and treatment-week.||Week 4: FAS||0.10|-0.74|0.137
72570905|NCT00292188|144670213|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.46|STANDARD_ERROR_OF_MEAN|0.22||0.041||95.0|-0.9|-0.02|||Mixed Models Analysis|Repeated Measures Mixed Models. Adjusted for treatment, week, baseline pain score, pooled country and treatment-week.||Week 5: FAS||-0.02|-0.90|0.041
72570906|NCT00292188|144670213|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.59|STANDARD_ERROR_OF_MEAN|0.22||0.009||95.0|-1.03|-0.15|||Mixed Models Analysis|Repeated Measures Mixed Models. Adjusted for treatment, week, baseline pain score, pooled country and treatment-week.||Week 6: FAS||-0.15|-1.03|0.009
72570907|NCT00292188|144670213|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.53|STANDARD_ERROR_OF_MEAN|0.25||0.035||95.0|-1.01|-0.04|||Mixed Models Analysis|Repeated Measures Mixed Models. Adjusted for treatment, week, baseline pain score, pooled country and treatment-week.||Week 7: FAS||-0.04|-1.01|0.035
72570908|NCT00292188|144670213|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.25||0.019||95.0|-1.1|-0.1|||Mixed Models Analysis|Repeated Measures Mixed Models. Adjusted for treatment, week, baseline pain score, pooled country and treatment-week.||Week 8: FAS||-0.10|-1.10|0.019
72570909|NCT00292188|144670214|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.84||||0.032||95.0|1.05|3.21|||Regression, Logistic|logstic regression adjusted for treatment group, baseline pain score and pooled country.||30% responder||3.21|1.05|0.032
72570910|NCT00292188|144670214|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.78||||0.088||95.0|0.92|3.46|||Regression, Logistic|logstic regression adjusted for treatment group, baseline pain score and pooled country.||50% responder||3.46|0.92|0.088
72570911|NCT00292188|144670215|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.79|STANDARD_ERROR_OF_MEAN|0.23||0.001||95.0|-1.25|-0.34|||ANCOVA|ANCOVA adjusted for treatment group, baseline score and pooled country.||||-0.34|-1.25|0.001
72570912|NCT00292188|144670216|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-10.72|STANDARD_ERROR_OF_MEAN|2.62||0||95.0|-15.89|-5.55|||ANCOVA|ANCOVA adjusted for treatment group, baseline score and pooled country.||Sleep Disturbance||-5.55|-15.89|0.000
72524027|NCT02725268|144577902|SUPERIORITY||Hazard Ratio (HR)|1.67|||=|0.224|TWO_SIDED|95.0|1.04|2.68||The p-value was obtained using stratified log-rank test with histological subtype, lines of prior chemotherapy and prior taxane therapy (original stratification values).|Stratified Log-rank Test||The hazard ratio was obtained using a stratified Cox proportional hazard model adjusted for histological subtype, lines of prior chemotherapy and prior taxane therapy. A hazard ratio of \<1 was considered statistically significant.|||2.68|1.04|=0.224
72524028|NCT02725268|144577902|SUPERIORITY||Hazard Ratio (HR)|2.28|||=|0.244|TWO_SIDED|95.0|1.32|3.96||The p-value was obtained using stratified log-rank test with histological subtype, lines of prior chemotherapy and prior taxane therapy (original stratification values).|Stratified Log-rank Test||The hazard ratio was obtained using a stratified Cox proportional hazard model adjusted for histological subtype, lines of prior chemotherapy and prior taxane therapy. A hazard ratio of \<1 was considered statistically significant.|||3.96|1.32|=0.244
72524029|NCT02725268|144577903|SUPERIORITY||Odds Ratio (OR)|1.39|||||TWO_SIDED|95.0|0.66|2.9|||||The odds ratio and 95% confidence intervals were obtained using a stratified Cochran-Mantel-Haenszel (CMH) model with histological subtype, lines of prior chemotherapy and prior taxane therapy (original stratification values).|||2.90|0.66|
72524030|NCT02725268|144577903|SUPERIORITY||Odds Ratio (OR)|0.22|||||TWO_SIDED|95.0|0.04|1.14|||||The odds ratio and 95% confidence intervals were obtained using a stratified CMH model with histological subtype, lines of prior chemotherapy and prior taxane therapy (original stratification values).|||1.14|0.04|
72524031|NCT02725268|144577903|SUPERIORITY||Odds Ratio (OR)|0.0|||||TWO_SIDED|95.0|0.0|0.0|||||The odds ratio and 95% confidence intervals were obtained using a stratified CMH model with histological subtype, lines of prior chemotherapy and prior taxane therapy (original stratification values).|||0.00|0.00|
72524032|NCT02725268|144577904|SUPERIORITY||Odds Ratio (OR)|3.02|||||TWO_SIDED|95.0|1.53|5.96|||||The odds ratio and 95% confidence intervals were obtained using a stratified CMH model with histological subtype, lines of prior chemotherapy and prior taxane therapy (original stratification values).|||5.96|1.53|
72524033|NCT02725268|144577904|SUPERIORITY||Odds Ratio (OR)|0.4|||||TWO_SIDED|95.0|0.18|0.86|||||The odds ratio and 95% confidence intervals were obtained using a stratified CMH model with histological subtype, lines of prior chemotherapy and prior taxane therapy (original stratification values).|||0.86|0.18|
72524034|NCT02725268|144577904|SUPERIORITY||Odds Ratio (OR)|0.43|||||TWO_SIDED|95.0|0.15|1.21|||||The odds ratio and 95% confidence intervals were obtained using a stratified CMH model with histological subtype, lines of prior chemotherapy and prior taxane therapy (original stratification values).|||1.21|0.15|
72570913|NCT00292188|144670216|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.05|STANDARD_ERROR_OF_MEAN|2.71||0.7||95.0|-4.3|6.4|||ANCOVA|ANCOVA adjusted for treatment group, baseline score and pooled country.||Snoring||6.40|-4.30|0.700
72570914|NCT00292188|144670216|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.95|STANDARD_ERROR_OF_MEAN|2.88||0.04||95.0|-11.62|-0.28|||ANCOVA|ANCOVA adjusted for treatment group, baseline score and pooled country.||Awaken Short of Breath/Headache||-0.28|-11.62|0.040
72524035|NCT02725268|144577905|SUPERIORITY||Odds Ratio (OR)|2.62|||||TWO_SIDED|95.0|0.89|7.67|||||The odds ratio and 95% confidence intervals were obtained using a stratified CMH model with histological subtype, lines of prior chemotherapy and prior taxane therapy (original stratification values).|||7.67|0.89|
72524036|NCT02725268|144577905|SUPERIORITY||Odds Ratio (OR)|0.15|||||TWO_SIDED|95.0|0.05|0.51|||||The odds ratio and 95% confidence intervals were obtained using a stratified CMH model with histological subtype, lines of prior chemotherapy and prior taxane therapy (original stratification values).|||0.51|0.05|
72524037|NCT02725268|144577905|SUPERIORITY||Odds Ratio (OR)|0.07|||||TWO_SIDED|95.0|0.01|0.67|||||The odds ratio and 95% confidence intervals were obtained using a stratified CMH model with histological subtype, lines of prior chemotherapy and prior taxane therapy (original stratification values).|||0.67|0.01|
72570915|NCT00292188|144670216|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.08|STANDARD_ERROR_OF_MEAN|0.42||0.846||95.0|-0.92|0.76|||ANCOVA|ANCOVA adjusted for treatment group, baseline score and pooled country.||Sleep Quantity||0.76|-0.92|0.846
72524038|NCT01838304|144577908|OTHER||Odds Ratio (OR)|7.9|||<|0.0001|TWO_SIDED|95.0|4.21|14.81|||Fisher Exact|||Fisher's exact test for odd's ratio of time below a saturation of 80% to total time||14.81|4.21|<0.0001
72524039|NCT03674541|144577910|SUPERIORITY|||||||0.043|||||||Welch's t-test|||||||0.043
72524040|NCT03674541|144577911|SUPERIORITY|||||||0.008||||||P-value was not adjusted for multiplicity for secondary outcomes|Welch's t-test|||||||0.008
72524041|NCT03674541|144577912|SUPERIORITY|||||||0.263||||||Not adjusted for multiplicity|Welch's t-test|||||||0.263
72524042|NCT03674541|144577913|SUPERIORITY|||||||0.039||||||Not adjusted for multiplicity|Welch's t-test|||||||0.039
72524043|NCT03674541|144577914|SUPERIORITY|||||||0.068||||||Not adjusted for multiplicity|Welch's t-test|||||||0.068
72524044|NCT03674541|144577915|SUPERIORITY|||||||0.045||||||Not adjusted for multiplicity|Welch's t-test|||||||0.045
72524045|NCT03674541|144577916|SUPERIORITY|||||||1||||||Not adjusted multiplicity|Welch's t-test|||||||1.000
72524046|NCT03674541|144577917|SUPERIORITY|||||||0.093||||||Not adjusted for multiplicity|Welch's t-test|||||||0.093
72524047|NCT03674541|144577918|SUPERIORITY|||||||0.427||||||Not adjusted for multiplicity|Welch's t-test|||||||0.427
72524048|NCT03674541|144577919|SUPERIORITY|||||||0.262||||||Not adjusted for multiplicity|Welch's t-test|||||||0.262
72524049|NCT03674541|144577920|SUPERIORITY|||||||0.038||||||Not adjusted for multiplicity|Welch's t-test|||||||0.038
72524050|NCT03674541|144577921|SUPERIORITY|||||||0.147|||||||Welch's t-test|||||||0.147
72524051|NCT00117572|144577979|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.91||||0.68|TWO_SIDED|95.0|0.59|1.41|||Log Rank||Hazard ratio is (Induction+CRT)/CRT|Comparison of overall survival curves||1.41|0.59|0.68
72524052|NCT00117572|144577980|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.83||||0.37|TWO_SIDED|95.0|0.55|1.25|||Log Rank||Hazard ratio is (Induction+CRT)/CRT|||1.25|0.55|0.37
72524053|NCT00117572|144577981|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.76||||0.16|TWO_SIDED|95.0|0.51|1.12|||Log Rank||Hazard ratio is (Induction+CRT)/CRT|||1.12|0.51|0.16
72524054|NCT00117572|144577982|SUPERIORITY_OR_OTHER|||||||0.57|||||||Fisher Exact|||||||0.57
72524055|NCT00117572|144577983|SUPERIORITY_OR_OTHER|||||||0.11|||||||Fisher Exact|||||||0.11
72524056|NCT00117572|144577984|SUPERIORITY_OR_OTHER|||||||0.55|||||||t-test, 2 sided|Comparison of change scores between treatment groups||||||0.55
72406440|NCT02942017|144321622|SUPERIORITY||LS Mean Difference|-0.26|STANDARD_ERROR_OF_MEAN|0.126||0.0433|TWO_SIDED|95.0|-0.51|-0.01|||MMRM|||Agitation, Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.01|-0.51|0.0433
72406441|NCT02942017|144321622|SUPERIORITY||LS Mean Difference|-0.34|STANDARD_ERROR_OF_MEAN|0.118||0.0051|TWO_SIDED|95.0|-0.57|-0.1|||MMRM|||Agitation, Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.10|-0.57|0.0051
72406442|NCT02942017|144321622|SUPERIORITY||LS Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.133||0.0973|TWO_SIDED|95.0|-0.48|0.04|||MMRM|||Agitation, Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.04|-0.48|0.0973
72406443|NCT02942017|144321622|SUPERIORITY||LS Mean Difference|-0.38|STANDARD_ERROR_OF_MEAN|0.126||0.0036|TWO_SIDED|95.0|-0.63|-0.13|||MMRM|||Agitation, Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.13|-0.63|0.0036
72406444|NCT02942017|144321622|SUPERIORITY||LS Mean Difference|-0.26|STANDARD_ERROR_OF_MEAN|0.131||0.0498|TWO_SIDED|95.0|-0.52|0.0|||MMRM|||Agitation, Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.00|-0.52|0.0498
72406445|NCT02942017|144321622|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.147||0.5111|TWO_SIDED|95.0|-0.39|0.2|||MMRM|||Agitation, Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.20|-0.39|0.5111
72524057|NCT00117572|144577985|SUPERIORITY_OR_OTHER|||||||0.034|||||||t-test, 2 sided|||||||0.034
72406446|NCT02942017|144321622|SUPERIORITY||LS Mean Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.155||0.5839|TWO_SIDED|95.0|-0.39|0.22|||MMRM|||Agitation, Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.22|-0.39|0.5839
72406447|NCT02942017|144321622|SUPERIORITY||LS Mean Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.1||0.1905|TWO_SIDED|95.0|-0.33|0.07|||MMRM|||Agitation, Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.07|-0.33|0.1905
72406448|NCT02942017|144321622|SUPERIORITY||LS Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.162||0.1767|TWO_SIDED|95.0|-0.54|0.1|||MMRM|||Anxiety Psychic, Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.10|-0.54|0.1767
72406449|NCT02942017|144321622|SUPERIORITY||LS Mean Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.18||0.5182|TWO_SIDED|95.0|-0.47|0.24|||MMRM|||Anxiety Psychic, Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.24|-0.47|0.5182
72406450|NCT02942017|144321622|SUPERIORITY||LS Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.185||0.393|TWO_SIDED|95.0|-0.53|0.21|||MMRM|||Anxiety Psychic, Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.21|-0.53|0.3930
72524058|NCT00117572|144577986|SUPERIORITY_OR_OTHER|||||||0.35|||||||t-test, 2 sided|||||||0.35
72524059|NCT00117572|144577987|SUPERIORITY_OR_OTHER|||||||0.96|||||||t-test, 2 sided|||||||0.96
72524060|NCT00117572|144577988|SUPERIORITY_OR_OTHER|||||||0.88|TWO_SIDED||||||t-test, 2 sided|||||||0.88
72524061|NCT00117572|144577989|SUPERIORITY_OR_OTHER|||||||0.83|TWO_SIDED||||||t-test, 2 sided|||||||0.83
72524062|NCT00117572|144577990|SUPERIORITY_OR_OTHER|||||||0.49|TWO_SIDED||||||t-test, 2 sided|||||||0.49
72524063|NCT00117572|144577991|SUPERIORITY_OR_OTHER|||||||0.09|TWO_SIDED||||||t-test, 2 sided|||||||0.090
72524064|NCT04973085|144577997|OTHER|||||||0.02|||||||t-test, 2 sided|||||||0.02
72524065|NCT00412113|144578007|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|19.03|||<|0.001||95.0|9.14|39.63||There was only one primary endpoint and the p-value was not adjusted for comparison.|Cochran-Mantel-Haenszel|||"Null hypothesis: There is no difference between the two treatment management strategies in the percentage of patients achieving both the BP(\< 140/90 mmHg) and LDL goal (\< 100mg/dL) at Week 6.~With \~120 in each treatment arm, planned power was at least 90% to detect a difference between treatments, assuming 35% in the Caduet and 15% in the Norvasc arm achieving BP \<140/90 mmHg and LDL \<100 mg/dL and using a chi-square test with 0.05 two-sided significance level."||39.63|9.14|<0.001
72524066|NCT00412113|144578008|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|31.39|||<|0.001||95.0|12.61|78.09||No adjustment for p-value for secondary analysis|Cochran-Mantel-Haenszel|||Null hypothesis: There is no difference between the two treatment management strategies in the percentage of patients achieving both the blood pressure (\< 140/90 mmHg) and LDL-goal (\<100 mg/dL) at Week 4.||78.09|12.61|<0.001
72524067|NCT00412113|144578009|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|5.2|||<|0.001||95.0|2.93|9.24||No adjustment for p-value for secondary analyses|Cochran-Mantel-Haenszel|||Null hypothesis: There is no difference between the two treatment management strategies in the percentage of patients achieving both the blood pressure (\< 140/90 mmHg) and LDL-goal (\<130mg/dL) at Week 4.||9.24|2.93|<0.001
72524068|NCT00412113|144578010|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|5.14|||<|0.001||95.0|2.89|9.11||No adjustment for p-value for secondary analyses|Cochran-Mantel-Haenszel|||Null hypothesis: There is no difference between the two treatment management strategies in the percentage of patients achieving both the blood pressure (\< 140/90 mmHg) and LDL-goal (\<130mg/dL) at Week 6.||9.11|2.89|<0.001
72524069|NCT00412113|144578011|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|65.51|||<|0.001||95.0|27.1|158.34||No adjustment for p-value for secondary analyses|Cochran-Mantel-Haenszel|||Null hypothesis: There is no difference between the two treatment management strategies in the percentage of patients achieving (\<100mg/DL) at Week 4.||158.34|27.10|<0.001
72524070|NCT00412113|144578012|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|42.04|||<|0.001||95.0|19.42|90.99||No adjustment for p-value for secondary analyses|Cochran-Mantel-Haenszel|||Null hypothesis: There is no difference between the two treatment management strategies in the percentage of patients achieving LDL-goal (\<100mg/DL) at Week 6.||90.99|19.42|<0.001
72524071|NCT00412113|144578013|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.09||||0.785||95.0|0.6|1.98||No adjustment for p-value for secondary analyses|Cochran-Mantel-Haenszel|||Null hypothesis: There is no difference between the two treatment management strategies in the percentage of patients achieving blood pressure (\< 140/90 mmHg)at Week 4||1.98|0.60|0.785
72570916|NCT00292188|144670216|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|10.63|STANDARD_ERROR_OF_MEAN|3.27||0.001||95.0|4.19|17.07|||ANCOVA|ANCOVA adjusted for treatment group, baseline score and pooled country.||Sleep Adequacy||17.07|4.19|0.001
72570917|NCT00292188|144670216|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.31|STANDARD_ERROR_OF_MEAN|2.34||0.324||95.0|-2.3|6.92|||ANCOVA|ANCOVA adjusted for treatment group, baseline score and pooled country.||Somnolence||6.92|-2.30|0.324
72524072|NCT00412113|144578014|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.55||||0.171||95.0|0.83|2.88||No adjustment for p-value for secondary analyses|Cochran-Mantel-Haenszel|||Null hypothesis: There is no difference between the two treatment management strategies in the percentage of patients achieving blood pressure (\< 140/90 mmHg) at Week 6.||2.88|0.83|0.171
72524073|NCT00412113|144578015|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|0.76||||0.585||95.0|-1.97|3.48||No adjustment for p-value for secondary analyses|ANCOVA|||Null hypothesis: There is no difference between the two treatment management strategies in the mean change from baseline in systolic blood pressure at Week 4.||3.48|-1.97|0.585
72524074|NCT00412113|144578016|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|0.0|||>|0.999||95.0|-2.01|2.01||No adjustment for p-value for secondary analyses|ANCOVA|||Null hypothesis: There is no difference between the two treatment management strategies in the mean change from baseline in diastolic blood pressure at Week 4.||2.01|-2.01|> 0.999
72524075|NCT00412113|144578017|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.9||||0.363||95.0|-2.83|1.04|||ANCOVA|||Null hypothesis: There is no difference between the two treatment management strategies in the mean change from baseline in pulse rate at Week 4.||1.04|-2.83|0.363
72524076|NCT00412113|144578018|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS means|-3.25||||0.02||95.0|-5.99|-0.51||No adjustment for p-value for secondary analyses|ANCOVA|||Null hypothesis: There is no difference between the two treatment management strategies in the mean change from baseline in systolic blood pressure at Week 6.||-0.51|-5.99|0.020
72570918|NCT00292188|144670216|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-9.52|STANDARD_ERROR_OF_MEAN|2.63||0||95.0|-14.71|-4.33|||ANCOVA|ANCOVA adjusted for treatment group, baseline score and pooled country.||Sleep Problems Index-6||-4.33|-14.71|0.000
72524077|NCT00412113|144578019|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.87||||0.351||95.0|-2.71|0.97||No adjustment for p-value for secondary analyses|ANCOVA|||Null hypothesis: There is no difference between the two treatment management strategies in the mean change from baseline in diastolic blood pressure at Week 6.||0.97|-2.71|0.351
72524078|NCT00412113|144578020|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|0.1||||0.922||95.0|-1.91|2.11||No adjustment for p-value for secondary analyses|ANCOVA|||Null hypothesis: There is no difference between the two treatment management strategies in mean change from baseline in pulse rate at Week 6.||2.11|-1.91|0.922
72524079|NCT00412113|144578021|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-49.3|||<|0.001||95.0|-54.68|-43.91||No adjustment for p-value for secondary analyses|ANCOVA|||Null hypothesis: There is no difference between the two treatment management strategies in the mean change from baseline in LDL at Week 4.||-43.91|-54.68|<0.001
72524080|NCT00412113|144578022|SUPERIORITY_OR_OTHER_LEGACY||difference in LS Means|-0.3||||0.739||95.0|-2.07|1.47||No adjustment for p-value for secondary analyses|ANCOVA|||Null hypothesis: There is no difference between the two treatment management strategies in the mean change from baseline in HDL at Week 4.||1.47|-2.07|0.739
72524081|NCT00412113|144578023|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-57.9|||<|0.001||95.0|-64.02|51.81||No adjustment for p-value for secondary analyses|ANCOVA|||Null hypothesis: There is no difference between the two treatment management strategies in the mean change from baseline in TC at Week 4.||51.81|-64.02|<0.001
72524082|NCT00412113|144578024|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-47.27|||<|0.001||95.0|-63.37|-31.16||No adjustment for p-value for secondary analyses|ANCOVA|||Null hypothesis: There is no difference between the two treatment management strategies in the mean change from baseline in TG at Week 4.||-31.16|-63.37|<0.001
72524083|NCT00412113|144578025|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-51.21|||<|0.001||95.0|-56.88|-45.55||No adjustment for p-value for secondary analyses|ANCOVA|||Null hypothesis: There is no difference between the two treatment management strategies in the mean change from baseline in LDL at Week 6.||-45.55|-56.88|<0.001
72524084|NCT00412113|144578026|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-1.02||||0.329||95.0|-3.07|1.03||No adjustment for p-value for secondary analyses|ANCOVA|||Null hypothesis: There is no difference between the two treatment management strategies in the mean change from baseline in HDL at Week 6.||1.03|-3.07|0.329
72524085|NCT00412113|144578027|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-62.07|||<|0.001||95.0|-68.49|-55.65||No adjustment for p-value for secondary analyses|ANCOVA|||Null hypothesis: There is no difference between the two treatment management strategies in the mean change from baseline in TC at Week 6.||-55.65|-68.49|<0.001
72524086|NCT00412113|144578028|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-53.95|||<|0.001||95.0|-77.61|-30.29||No adjustment for p-value for secondary analyses|ANCOVA|||Null hypothesis: There is no difference between the two treatment management strategies in the mean change in TG from baseline in at Week 6.||-30.29|-77.61|<0.001
72524087|NCT00412113|144578029|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-2.4|||<|0.001||95.0|-3.1|-1.7||No adjustment for p-value for secondary analyses|ANCOVA|||Null hypothesis: There is no difference between the two treatment management strategies in mean change from baseline to Week 4 in Framingham predicted absolute 10-year risk.||-1.7|-3.1|<0.001
72524088|NCT00412113|144578030|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-2.8|||<|0.001||95.0|-3.5|-2.1||No adjustment for p-value for secondary analyses|ANCOVA|||Null hypothesis: There is no difference between the two treatment management strategies in the mean change from baseline to Week 6 in Framingham predicted absolute 10-year risk.||-2.1|-3.5|<0.001
72524089|NCT03991468|144578035|NON_INFERIORITY|A Mixed Model Repeated Measures logistic regression was used to prove WSI major discordance (MD) rate non-inferior to Glass MD rate. A two-sided 95% CI for the difference in MD rate was constructed. If the upper bound of the 95% CI was less than the non-inferiority margin of 4%, then WSI would be considered non-inferior to Glass, assuming power = 0.9 and alpha = 0.05 a sample size of 2000 was calculated to be sufficient to prove non-inferiority.|Mean Difference (Final Values)|0.4|||||TWO_SIDED|95.0|-0.1|1.0|||Mixed Models Analysis|Dependent var = major discordance status (yes/no); independent var = modality (WSI/Glass) as a fixed effect \& site, reader, \& case as random effects.||||1.0|-0.1|
72524090|NCT03573804|144578037|OTHER|A two-tailed paired T-test for equivalence was used to evaluate equivalence between the average raw tumor.|Mean Difference (Net)|224.675|STANDARD_ERROR_OF_MEAN|67.89|<|0.001|TWO_SIDED|95.0|90.26044|359.08956||Using an alpha value of 0.05, dof = 60, the null hypothesis of sample mean equivalence was rejected.|t-test, 2 sided|A paired two-tailed t-test was used on the paired prone-to-supine tumor intensity values.||Regions of interest (ROIs) for tumor were defined by the radiologist segmentation of tumor in supine and prone positions. ROIs for the surrounding tissue were selected such that tumor and normal regions had equal volumes. The alpha level was assumed to be of 0.05 (dof = 60), and the null hypothesis of equivalence (mu = 0).||359.08956|90.26044|<0.001
72524091|NCT03573804|144578038|OTHER|A two-tailed paired T-test was used to compare sample means in between the prone and supine mean benign tissue intensities.|Mean Difference (Net)|165.833|STANDARD_ERROR_OF_MEAN|44.19|<|0.001|TWO_SIDED|95.0|78.34708|253.31892||Using an alpha value of 0.05, dof = 60, the null hypothesis of sample mean equivalence was rejected.|t-test, 2 sided|A paired two-tailed t-test was used on the paired prone-to-supine normal tissue intensity values.||Regions of interest (ROIs) for surrounding tissues were selected as the surrounding benign tissue regions directly adjacent to the segmented tumor regions. Tumor and surrounding regions had equal volumes. The mean surrounding region intensities reported were all calculated from the prone and supine T1-weighted MR images segmented by the radiologist.||253.31892|78.34708|<0.001
72524092|NCT03573804|144578039|OTHER|A two-tailed paired T-test was used to compare sample means in between the prone and supine tumor-to-surrounding tissue ratios.|Mean Difference (Net)|0.12|STANDARD_ERROR_OF_MEAN|0.08||0.0058|TWO_SIDED|95.0|-0.04209|0.28209||Using an alpha value of 0.05, dof = 60, the null hypothesis of sample mean equivalence was rejected.|t-test, 2 sided|A two-tailed paired T-test was used to compare sample means in between the prone and supine tumor-to-surrounding tissue ratios.||The ratios of tumor-to-surrounding tissue intensities, as calculated in Secondary Objective Part A, were compared between prone and supine T1-weighted MR image scans.||0.28209|-0.04209|0.0058
72524093|NCT03573804|144578041|SUPERIORITY|||||||0.00049664|||||||Students two-tailed paired t-test|||||||0.00049664
72524094|NCT01425307|144578042|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|We hypothesized that the Alternative arm mean TCD velocity at 24 months will be less than the Standard arm mean TCD velocity plus 15cm/sec. We used Lan-DeMets boundaries to control overall Type I error rate at α = 0.05. For looks at exactly 1/3, 2/3, and 100 percent of the completed subjects, the cumulative α were estimated to be 0.0001, 0.001, and 0.05, respectively.|Mean Difference (Final Values)|4.54|||<|0.05|TWO_SIDED|95.0|0.1|8.98||P value for non inferiority was 8.82 X 10\^-16|Mixed Models Analysis|Linear mixed model||Participants were randomized at a central site, stratified by site with a block size of four, and an adaptive randomization scheme was used to balance the covariates of baseline age and TCD velocity. The treatment period lasted 24 months. The primary study endpoint was the 24 month TCD velocity calculated from a general linear mixed model, with the non-inferiority margin set at 15 cm/s. The primary analysis was done in the intention-to-treat population.||8.98|0.10|<0.05
72524095|NCT01425307|144578046|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
72524096|NCT01425307|144578056|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0011|||||||t-test, 2 sided|||||||0.0011
72524097|NCT04507360|144578062|SUPERIORITY||Mean Difference (Final Values)|0.23|||||TWO_SIDED|||||||||"Mean difference in Overall row"||||
72524098|NCT04507360|144578064|SUPERIORITY||Mean Difference (Final Values)|0.96|||||TWO_SIDED|||||||||Mean difference in total score at week 1||||
72524099|NCT04507360|144578064|SUPERIORITY||Mean Difference (Final Values)|0.63|||||TWO_SIDED|||||||||Mean difference in total score at week 2||||
72524100|NCT04507360|144578064|SUPERIORITY||Mean Difference (Final Values)|0.19|||||TWO_SIDED|||||||||Mean difference in total score at week 3||||
72524101|NCT04507360|144578064|SUPERIORITY||Mean Difference (Final Values)|0.62|||||TWO_SIDED|||||||||Mean difference in total score at week 4||||
72524102|NCT04507360|144578064|SUPERIORITY||Mean Difference (Final Values)|0.85|||||TWO_SIDED|||||||||Mean difference in total score at week 8||||
72524103|NCT04507360|144578064|SUPERIORITY||Mean Difference (Final Values)|0.41|||||TWO_SIDED|||||||||Mean difference in total score at week 1||||
72524104|NCT04507360|144578064|SUPERIORITY||Mean Difference (Final Values)|1.39|||||TWO_SIDED|||||||||Mean difference in total score at week 2||||
72524105|NCT04507360|144578064|SUPERIORITY||Mean Difference (Final Values)|2.16|||||TWO_SIDED|||||||||Mean difference in total score at week 3||||
72524106|NCT04507360|144578064|SUPERIORITY||Mean Difference (Final Values)|2.69|||||TWO_SIDED|||||||||Mean difference in total score at week 4||||
72524107|NCT04507360|144578064|SUPERIORITY||Mean Difference (Final Values)|1.75|||||TWO_SIDED|||||||||Mean difference in total score at week 8||||
72524108|NCT04507360|144578065|SUPERIORITY||Mean Difference (Final Values)|0.07|||||TWO_SIDED|||||||||Mean difference in total score at week 1||||
72524109|NCT04507360|144578065|SUPERIORITY||Mean Difference (Final Values)|0.42|||||TWO_SIDED|||||||||Mean difference in total score at week 2||||
72406451|NCT02942017|144321622|SUPERIORITY||LS Mean Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.189||0.5212|TWO_SIDED|95.0|-0.5|0.25|||MMRM|||Anxiety Psychic, Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.25|-0.50|0.5212
72524110|NCT04507360|144578065|SUPERIORITY||Mean Difference (Final Values)|0.4|||||TWO_SIDED|||||||||Mean difference in total score at week 3||||
72524111|NCT04507360|144578065|SUPERIORITY||Mean Difference (Final Values)|0.32|||||TWO_SIDED|||||||||Mean difference in total score at week 4||||
72524112|NCT04507360|144578066|SUPERIORITY||Mean Difference (Final Values)|0.01|||||TWO_SIDED|||||||||Mean difference in total score at week 1||||
72524113|NCT04507360|144578066|SUPERIORITY||Mean Difference (Final Values)|0.37|||||TWO_SIDED|||||||||Mean difference in total score at week 2||||
72524114|NCT04507360|144578066|SUPERIORITY||Mean Difference (Final Values)|0.01|||||TWO_SIDED|||||||||Mean difference in total score at week 3||||
72524115|NCT04507360|144578066|SUPERIORITY||Mean Difference (Final Values)|0.29|||||TWO_SIDED|||||||||Mean difference in total score at week 4||||
72524116|NCT04507360|144578067|SUPERIORITY||Mean Difference (Final Values)|0.58|||||TWO_SIDED|||||||||Mean difference in total score at week 1||||
72524117|NCT04507360|144578067|SUPERIORITY||Mean Difference (Final Values)|0.08|||||TWO_SIDED|||||||||Mean difference in total score at week 2||||
72524118|NCT04507360|144578067|SUPERIORITY||Mean Difference (Final Values)|1.24|||||TWO_SIDED|||||||||Mean difference in total score at week 3||||
72524119|NCT04507360|144578067|SUPERIORITY||Mean Difference (Final Values)|0.47|||||TWO_SIDED|||||||||Mean difference in total score at week 4||||
72524120|NCT04507360|144578067|SUPERIORITY||Mean Difference (Final Values)|0.03|||||TWO_SIDED|||||||||Mean difference in total score at week 8||||
72524121|NCT04507360|144578067|SUPERIORITY||Mean Difference (Final Values)|1.98|||||TWO_SIDED|||||||||Mean difference in total score at week 1||||
72524122|NCT04507360|144578067|SUPERIORITY||Mean Difference (Final Values)|1.18|||||TWO_SIDED|||||||||Mean difference in total score at week 2||||
72524123|NCT04507360|144578067|SUPERIORITY||Mean Difference (Final Values)|3.67|||||TWO_SIDED|||||||||Mean difference in total score at week 3||||
72524124|NCT04507360|144578067|SUPERIORITY||Mean Difference (Final Values)|4.22|||||TWO_SIDED|||||||||Mean difference in total score at week 4||||
72524125|NCT04507360|144578067|SUPERIORITY||Mean Difference (Final Values)|2.07|||||TWO_SIDED|||||||||Mean difference in total score at week 8||||
72524126|NCT04507360|144578070|SUPERIORITY||Mean Difference (Final Values)|0.31|||||TWO_SIDED|||||||||Mean difference at baseline||||
72524127|NCT04507360|144578070|SUPERIORITY||Mean Difference (Final Values)|0.29|||||TWO_SIDED|||||||||Mean difference at week 1||||
72524128|NCT04507360|144578070|SUPERIORITY||Mean Difference (Final Values)|0.12|||||TWO_SIDED|||||||||Mean difference at week 2||||
72524129|NCT04507360|144578070|SUPERIORITY||Mean Difference (Final Values)|0.13|||||TWO_SIDED|||||||||Mean difference at week 3||||
72524130|NCT04507360|144578070|SUPERIORITY||Mean Difference (Final Values)|1.68|||||TWO_SIDED|||||||||Mean difference at week 4||||
72524131|NCT04507360|144578070|SUPERIORITY||Mean Difference (Final Values)|0.16|||||TWO_SIDED|||||||||Mean difference at week 8||||
72524132|NCT04507360|144578070|SUPERIORITY||Mean Difference (Final Values)|0.28|||||TWO_SIDED|||||||||Mean difference at baseline||||
72524133|NCT04507360|144578070|SUPERIORITY||Mean Difference (Final Values)|0.67|||||TWO_SIDED|||||||||Mean difference at week 1||||
72524134|NCT04507360|144578070|SUPERIORITY||Mean Difference (Final Values)|0.78|||||TWO_SIDED|||||||||Mean difference at week 2||||
72524135|NCT04507360|144578070|SUPERIORITY||Mean Difference (Final Values)|0.18|||||TWO_SIDED|||||||||Mean difference at week 3||||
72524136|NCT04507360|144578070|SUPERIORITY||Mean Difference (Final Values)|0.47|||||TWO_SIDED|||||||||Mean difference at week 4||||
72524137|NCT04507360|144578070|SUPERIORITY||Mean Difference (Final Values)|0.24|||||TWO_SIDED|||||||||Mean difference at week 8||||
72524138|NCT04507360|144578071|SUPERIORITY||Mean Difference (Final Values)|0.18|||||TWO_SIDED|||||||||Mean difference at baseline||||
72524139|NCT04507360|144578071|SUPERIORITY||Mean Difference (Final Values)|0.15|||||TWO_SIDED|||||||||Mean difference at week 1||||
72524140|NCT04507360|144578071|SUPERIORITY||Mean Difference (Final Values)|0.23|||||TWO_SIDED|||||||||Mean difference at week 2||||
72524141|NCT04507360|144578071|SUPERIORITY||Mean Difference (Final Values)|0.38|||||TWO_SIDED|||||||||Mean difference at week 3||||
72524142|NCT04507360|144578071|SUPERIORITY||Mean Difference (Final Values)|1.26|||||TWO_SIDED|||||||||Mean difference at week 4||||
72524143|NCT04507360|144578071|SUPERIORITY||Mean Difference (Final Values)|0.26|||||TWO_SIDED|||||||||Mean difference at week 8||||
72524144|NCT04507360|144578071|SUPERIORITY||Mean Difference (Final Values)|0.09|||||TWO_SIDED|||||||||Mean difference at baseline||||
72524145|NCT04507360|144578071|SUPERIORITY||Mean Difference (Final Values)|0.26|||||TWO_SIDED|||||||||Mean difference at week 1||||
72524146|NCT04507360|144578071|SUPERIORITY||Mean Difference (Final Values)|0.05|||||TWO_SIDED|||||||||Mean difference at week 2||||
72524147|NCT04507360|144578071|SUPERIORITY||Mean Difference (Final Values)|0.3|||||TWO_SIDED|||||||||Mean difference at week 3||||
72524148|NCT04507360|144578071|SUPERIORITY||Mean Difference (Final Values)|0.3|||||TWO_SIDED|||||||||Mean difference at week 4||||
72524149|NCT04507360|144578071|SUPERIORITY||Mean Difference (Final Values)|0.4|||||TWO_SIDED|||||||||Mean difference at week 8||||
72524150|NCT04058990|144578074|NON_INFERIORITY|13.2% non-inferiority margin||||||0.0012|||||||Farrington-Manning|||\[Not Specified\]||||0.0012
72406452|NCT02942017|144321622|SUPERIORITY||LS Mean Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.184||0.4741|TWO_SIDED|95.0|-0.5|0.23|||MMRM|||Anxiety Psychic, Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.23|-0.50|0.4741
72406453|NCT02942017|144321622|SUPERIORITY||LS Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.186||0.4482|TWO_SIDED|95.0|-0.51|0.23|||MMRM|||Anxiety Psychic, Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.23|-0.51|0.4482
72406454|NCT02942017|144321622|SUPERIORITY||LS Mean Difference|-0.31|STANDARD_ERROR_OF_MEAN|0.187||0.0963|TWO_SIDED|95.0|-0.69|0.06|||MMRM|||Anxiety Psychic, Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.06|-0.69|0.0963
72524151|NCT03050307|144578076|NON_INFERIORITY|If the lower bound of the 95% CI is ≥-8%, noninferiority for TAK-438 relative to lansoprazole with regard to gastric ulcer healing was declared.|Exact (Clopper-Pearson)|-3.7|||||TWO_SIDED|95.0|-10.966|3.339||||||||3.339|-10.966|
72524152|NCT03050307|144578077|NON_INFERIORITY|If the primary outcome measure was met, then the hypothesis for this outcome measure was that if the lower bound of the 95% CI of the difference was ≥-10%, noninferiority for TAK-438 relative to lansoprazole with regard to H pylori eradication was declared.|Exact (Clopper-Pearson)|7.2|||||TWO_SIDED|95.0|-4.469|18.825||||||||18.825|-4.469|
72524153|NCT03050307|144578078|NON_INFERIORITY|If the lower bound of the 95% CI is ≥-8%, noninferiority for TAK-438 relative to lansoprazole with regard to gastric ulcer healing was declared.|Exact (Clopper-Pearson)|-6.0|||||TWO_SIDED|95.0|-16.644|4.741||||||||4.741|-16.644|
72524154|NCT03050307|144578079|OTHER|If the lower bound of the 95% CI is ≥-8%, noninferiority for TAK-438 relative to lansoprazole with regard to gastric ulcer healing was declared.|Exact (Clopper-Pearson)|-1.1|||||TWO_SIDED|95.0|-25.175|23.07||||||Epigastric Pain (Postprandial)||23.070|-25.175|
72524155|NCT03050307|144578079|NON_INFERIORITY|If the lower bound of the 95% CI is ≥-8%, noninferiority for TAK-438 relative to lansoprazole with regard to gastric ulcer healing was declared.|Exact (Clopper-Pearson)|4.5|||||TWO_SIDED|95.0|-11.907|20.931||||||Epigastric Pain (Fasting/Nocturnal)||20.931|-11.907|
72524156|NCT03050307|144578079|NON_INFERIORITY|If the lower bound of the 95% CI is ≥-8%, noninferiority for TAK-438 relative to lansoprazole with regard to gastric ulcer healing was declared.|Exact (Clopper-Pearson)|16.0|||||TWO_SIDED|95.0|-11.255|43.321||||||Abdominal Bloating||43.321|-11.255|
72524157|NCT03050307|144578079|NON_INFERIORITY|If the lower bound of the 95% CI is ≥-8%, noninferiority for TAK-438 relative to lansoprazole with regard to gastric ulcer healing was declared.|Exact (Clopper-Pearson)|10.1|||||TWO_SIDED|95.0|-5.109|25.348||||||Heartburn||25.348|-5.109|
72524158|NCT03050307|144578079|NON_INFERIORITY|If the lower bound of the 95% CI is ≥-8%, noninferiority for TAK-438 relative to lansoprazole with regard to gastric ulcer healing was declared.|Exact (Clopper-Pearson)|-12.2|||||TWO_SIDED|95.0|-45.138|20.694||||||Lack of Appetite||20.694|-45.138|
72524159|NCT01998906|144578090|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|17.6||||0.0051|TWO_SIDED|95.0|5.0|30.2|||Chi-squared|||||30.2|5.0|0.0051
72524160|NCT01998906|144578091|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|19.3||||0.0014|TWO_SIDED|95.0|7.2|31.4|||Chi-squared|||||31.4|7.2|0.0014
72524161|NCT01998906|144578092|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.4||||0.3077|TWO_SIDED|95.0|-6.4|19.1|||Chi-squared|||||19.1|-6.4|0.3077
72524162|NCT01998906|144578094|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.65||||0.0275|TWO_SIDED|95.0|0.44|0.96|||Log Rank|||||0.96|0.44|0.0275
72524163|NCT01998906|144578096|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.59||||0.0555|TWO_SIDED|95.0|0.35|1.02|||Log Rank|||||1.02|0.35|0.0555
72524164|NCT05724069|144578102|SUPERIORITY||Median Difference (Net)|-0.239|||=|0.1279|TWO_SIDED|95.0|-0.553|0.074|||paired T-test|||Subjects in this analysis are 15 and not 30 (this happens because arms are not mutually exclusive, as explained in previous sections). Each subject can contribute with 0, 1, 2 pairs. Only data that constitute pairs evaluable for primary endpoint are considered in the analysis; the pairs evaluable for primary endpoint were 23.||0.074|-0.553|=0.1279
72524165|NCT03552289|144578103|SUPERIORITY|||||||0.8283|||||||One-sided Z-test|||||||0.8283
72524166|NCT01077193|144578122|NON_INFERIORITY_OR_EQUIVALENCE|See above.|Mean Percent Excess Weight Loss|37.9|STANDARD_DEVIATION|25.18||0.3227|TWO_SIDED|95.0|30.2|45.5||No multiple comparison adjustments are necessary as this is a single hypothesis on 1 parameter for a within group change comparison to 36.1%.|t-test, 1 sided|||A sample size of 32 achieves power\>90% to demonstrate non-inferiority using a one-sided t-test (alpha=0.025) when the margin of equivalence is a 5% difference in EWL. The true difference between %EWL for patients undergoing a greater curvature procedure and the target %EWL is hypothesized to be 0. The target %EWL at 3 years is 41.1%, based upon prior studies. This power analysis assumes data are drawn from a single population with a standard deviation of 8.20.||45.5|30.2|0.3227
72524167|NCT06048809|144578125|OTHER|||||||2.36e-05|||||||ANCOM-BC2|||Haemophilus parainfluenzae: Change From Baseline at Week 6||||0.0000236
72524168|NCT06048809|144578125|OTHER|||||||0.0033243|||||||ANCOM-BC2|||Neisseria elongata: Change From Baseline at Week 6||||0.0033243
72524169|NCT06048809|144578125|OTHER|||||||0.00500088|||||||ANCOM-BC2|||Aggregatibacter sp.\_HMT\_898: Change From Baseline at Week 6||||0.00500088
72524170|NCT06048809|144578125|OTHER|||||||0.0066975|||||||ANCOM-BC2|||Parvimonas sp.\_HMT\_110: Change From Baseline at Week 6||||0.0066975
72524171|NCT06048809|144578125|OTHER|||||||0.00710228|||||||ANCOM-BC2|||Aggregatibacter aphrophilus: Change From Baseline at Week 6||||0.00710228
72524172|NCT06048809|144578125|OTHER|||||||0.00744022|||||||ANCOM-BC2|||Kingella oralis: Change From Baseline at Week 6||||0.00744022
72524173|NCT06048809|144578125|OTHER|||||||0.01434037|||||||ANCOM-BC2|||Haemophilus sp.\_HMT\_036: Change From Baseline at Week 6||||0.01434037
72524174|NCT06048809|144578125|OTHER|||||||0.01955327|||||||ANCOM-BC2|||Haemophilus haemolyticus: Change From Baseline at Week 6||||0.01955327
72570919|NCT00292188|144670216|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-7.54|STANDARD_ERROR_OF_MEAN|2.02||0||95.0|-11.52|-3.56|||ANCOVA|ANCOVA adjusted for treatment group, baseline score and pooled country.||Sleep Problems Index-9||-3.56|-11.52|0.000
72524175|NCT06048809|144578125|OTHER|||||||0.01995277|||||||ANCOM-BC2|||Neisseria mucosa: Change From Baseline at Week 6||||0.01995277
72524176|NCT06048809|144578125|OTHER|||||||0.02082528|||||||ANCOM-BC2|||Parvimonas sp.\_HMT\_393\_nov\_97.053%: Change From Baseline at Week 6||||0.02082528
72524177|NCT06048809|144578125|OTHER|||||||0.02188156|||||||ANCOM-BC2|||Ottowia sp.\_HMT\_894: Change from Baseline at Week 6||||0.02188156
72524178|NCT06048809|144578125|OTHER|||||||0.02321733|||||||ANCOM-BC2|||Cryptobacterium curtum: Change From Baseline at Week 6||||0.02321733
72524179|NCT06048809|144578125|OTHER|||||||0.02397996|||||||ANCOM-BC2|||Lautropia mirabilis: Change from Baseline at Week 6||||0.02397996
72524180|NCT06048809|144578125|OTHER|||||||0.02509094|||||||ANCOM-BC2|||Haemophilus paraphrohaemolyticus: Change From Baseline at Week 6||||0.02509094
72570920|NCT00292188|144670217|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.42||||0.267||95.0|0.76|2.64|||Regression, Logistic|Logistic regression adjusted for treatment group, baseline score and pooled country.||||2.64|0.76|0.267
72524181|NCT06048809|144578125|OTHER|||||||0.02648847|||||||ANCOM-BC2|||Capnocytophaga sp.\_HMT\_332: Change From Baseline at Week 6||||0.02648847
72524182|NCT06048809|144578125|OTHER|||||||0.02828764|||||||ANCOM-BC2|||Neisseria flavescens: Change From Baseline at Week 6||||0.02828764
72524183|NCT06048809|144578125|OTHER|||||||0.03454372|||||||ANCOM-BC2|||Capnocytophaga gingivalis\_nov\_96.429%: Change From Baseline at Week 6||||0.03454372
72524184|NCT06048809|144578125|OTHER|||||||0.03747507|||||||ANCOM-BC2|||Capnocytophaga sputigena: Change From Baseline at Week 6||||0.03747507
72524185|NCT06048809|144578125|OTHER|||||||0.03776136|||||||ANCOM-BC2|||Haemophilus sputorum: Change From Baseline at Week 6||||0.03776136
72524186|NCT06048809|144578125|OTHER|||||||0.03853215|||||||ANCOM-BC2|||Capnocytophaga gingivalis\_nov\_90.546%: Change From Baseline at Week 6||||0.03853215
72524187|NCT06048809|144578125|OTHER|||||||0.04751303|||||||ANCOM-BC2|||Prevotella denticola: Change From Baseline at Week 6||||0.04751303
72524188|NCT06048809|144578125|OTHER|||||||0.05190512|||||||ANCOM-BC2|||Aggregatibacter sp.\_HMT\_513: Change From Baseline at Week 6||||0.05190512
72524189|NCT06048809|144578125|OTHER|||||||0.0550647|||||||ANCOM-BC2|||Veillonella sp.\_HMT\_780: Change From Baseline at Week 6||||0.0550647
72524190|NCT06048809|144578125|OTHER|||||||0.05861488|||||||ANCOM-BC2|||Neisseria perflava: Change From Baseline at Week 6||||0.05861488
72524191|NCT06048809|144578125|OTHER|||||||0.06727926|||||||ANCOM-BC2|||Slackia exigua: Change From Baseline at Week 6||||0.06727926
72524192|NCT06048809|144578125|OTHER|||||||0.07051698|||||||ANCOM-BC2|||Shuttleworthia satelles: Change from Baseline at Week 6||||0.07051698
72524193|NCT06048809|144578125|OTHER|||||||0.0740793|||||||ANCOM-BC2|||Aggregatibacter sp.\_HMT\_458: Change From Baseline at Week 6||||0.0740793
72524194|NCT06048809|144578125|OTHER|||||||0.07426973|||||||ANCOM-BC2|||Ruminococcaceae\_\[G-1\] bacterium\_HMT\_075: Change From Baseline at Week 6||||0.07426973
72524195|NCT06048809|144578125|OTHER|||||||0.07829888|||||||ANCOM-BC2|||Campylobacter showae: Change From Baseline at Week 6||||0.07829888
72524196|NCT06048809|144578125|OTHER|||||||0.08462924|||||||ANCOM-BC2|||Streptococcus sp.\_HMT\_056: Change From Baseline at Week 6||||0.08462924
72524197|NCT06048809|144578126|OTHER|||||||0.062378|||||||ANCOM-BC2|||Abiotrophia defectiva: Change from Baseline at Week 6||||0.062378
72524198|NCT06048809|144578126|OTHER|||||||0.063437|||||||ANCOM-BC2|||Saccharibacteria\_(TM7)\_\[G1\] bacterium\_HMT\_346: Change from Baseline at Week 6||||0.063437
72524199|NCT06048809|144578126|OTHER|||||||0.069908|||||||ANCOM-BC2|||Olsenella sp.\_HMT\_807: Change from Baseline at Week 6||||0.069908
72524200|NCT06048809|144578126|OTHER|||||||0.079736|||||||ANCOM-BC2|||Fusobacterium nucleatum\_nucleatum\_subsp.\_animalis: Change from Baseline at Week 6||||0.079736
72524201|NCT06048809|144578126|OTHER|||||||0.094642|||||||ANCOM-BC2|||Bergeyella sp.\_HMT\_322: Change from Baseline at Week 6||||0.094642
72524202|NCT06048809|144578126|OTHER|||||||0.095848|||||||ANCOM-BC2|||Peptostreptococcaceae\_\[XI\]\[G-1\] \[Eubacterium\]\_infirmum: Change from Baseline at Week 6||||0.095848
72524203|NCT06048809|144578126|OTHER|||||||0.107931|||||||ANCOM-BC2|||Prevotella sp.\_HMT\_317: Change from Baseline at Week 6||||0.107931
72524204|NCT06048809|144578126|OTHER|||||||0.109114|||||||ANCOM-BC2|||Bacteroidales\_\[G-2\] bacterium\_HMT\_274: Change from Baseline at Week 6||||0.109114
72524205|NCT06048809|144578126|OTHER|||||||0.11083|||||||ANCOM-BC2|||Actinomyces sp.\_HMT\_175\_nov 97.951%: Change from Baseline at Week 6||||0.11083
72524206|NCT06048809|144578126|OTHER|||||||0.120377|||||||ANCOM-BC2|||Slackia exigua: Change from Baseline at Week 6||||0.120377
72524207|NCT06048809|144578126|OTHER|||||||0.123758|||||||ANCOM-BC2|||Granulicatella adiacens: Change from Baseline at Week 6||||0.123758
72524208|NCT06048809|144578126|OTHER|||||||0.123992|||||||ANCOM-BC2|||Prevotella oris: Change from Baseline at Week 6||||0.123992
72524209|NCT06048809|144578126|OTHER|||||||0.133385|||||||ANCOM-BC2|||Streptococcus sp.\_HMT\_064: Change from Baseline at Week 6||||0.133385
72524210|NCT06048809|144578126|OTHER|||||||0.144598|||||||ANCOM-BC2|||Schaalia odontolyticus: Change from Baseline at Week 6||||0.144598
72524211|NCT06048809|144578126|OTHER|||||||0.147278|||||||ANCOM-BC2|||Mogibacterium diversum: Change from Baseline at Week 6||||0.147278
72524212|NCT06048809|144578126|OTHER|||||||0.148674|||||||ANCOM-BC2|||Prevotella denticola: Change from Baseline at Week 6||||0.148674
72524213|NCT06048809|144578126|OTHER|||||||0.149722|||||||ANCOM-BC2|||Absconditabacteria\_(SR1)\_\[G-1\] bacterium\_HMT\_875: Change from Baseline at Week 6||||0.149722
72524214|NCT06048809|144578126|OTHER|||||||0.154465|||||||ANCOM-BC2|||Prevotella nigrescens: Change from Baseline at Week 6||||0.154465
72524215|NCT06048809|144578126|OTHER|||||||0.158139|||||||ANCOM-BC2|||Streptococcus chosunense: Change from Baseline at Week 6||||0.158139
72524216|NCT01536418|144578133|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.1|||||TWO_SIDED|95.0|-3.0|19.3||||||||19.3|-3.0|
72570921|NCT00292188|144670225|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.84|STANDARD_ERROR_OF_MEAN|2.25||0.09||95.0|-8.28|0.61|||ANCOVA|||||0.61|-8.28|0.090
72570922|NCT00824616|144670235|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.11||||0.745|TWO_SIDED|95.0|-0.81|0.58|||Longitudinal Data Analysis (LDA) model|||||0.58|-0.81|0.745
72524217|NCT01536418|144578134|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.5|||||TWO_SIDED|95.0|-5.8|10.8||||||CDAI score (Clinical remission), GSK1605786A, 500 mg QD Vs GSK1605786A, 500 mg BID; at Week 8||10.8|-5.8|
72524218|NCT01536418|144578134|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|5.6|||||TWO_SIDED|95.0|-3.0|14.3||||||CDAI score (Clinical remission), GSK1605786A, 500 mg QD Vs GSK1605786A, 500 mg BID; at Week 12||14.3|-3.0|
72524219|NCT01536418|144578134|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.4|||||TWO_SIDED|95.0|-4.6|9.5||||||CDAI score (Clinical remission), GSK1605786A, 500 mg QD Vs GSK1605786A, 500 mg BID; at both Weeks 8 and 12||9.5|-4.6|
72524220|NCT01536418|144578135|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.0|||||TWO_SIDED|95.0|-6.0|15.9||||||CDAI score (Clinical response), GSK1605786A, 500 mg QD Vs GSK1605786A, 500 mg BID at Week 8||15.9|-6.0|
72524221|NCT01536418|144578135|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.9|||||TWO_SIDED|95.0|-1.0|18.7||||||CDAI score (Clinical response), GSK1605786A, 500 mg QD Vs GSK1605786A, 500 mg BID at both Week 8 and Week 12||18.7|-1.0|
72524222|NCT00628134|144578140|SUPERIORITY_OR_OTHER|||||||0.07||95.0|||||Wilcoxon (Mann-Whitney)|||Wilcoxon matched-pairs signed-ranks test was used for comparisons||||0.07
72524223|NCT00628134|144578141|SUPERIORITY_OR_OTHER|||||||0.29||95.0|||||Wilcoxon (Mann-Whitney)|||Wilcoxon matched-pairs signed-ranks test was used for comparisons||||0.29
72524224|NCT03687827|144578142|SUPERIORITY|Superiority is confirmed if non-inferiority is confirmed and the lower limit of the two-sided 95% confidence interval is entirely above zero.|Estimated treatment difference|1.43||||0.0321|TWO_SIDED|95.0|0.12|2.74|||t-test, 2 sided|||||2.74|0.12|0.0321
72524225|NCT03687827|144578142|NON_INFERIORITY|A non-inferiority margin of -0.83% has been applied, corresponding to 0.2 hours/24 hours|Estimated treatment difference|1.43|||||TWO_SIDED|95.0|0.12|2.74||||||||2.74|0.12|
72524226|NCT01957085|144578149|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.04||||||Statistical significance was set at .05 to determine statistical significance.|Chi-squared|||||||=.04
72524227|NCT01957085|144578150|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|||||||Chi-squared|||||||>.05
72524228|NCT01957085|144578151|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|||||||Chi-squared|||||||>.05
72524229|NCT01957085|144578153|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|||||||Chi-squared|||||||>.05
72524230|NCT03748420|144578154|SUPERIORITY||Odds Ratio (OR)|1.29|STANDARD_ERROR_OF_MEAN|0.09845||0.0103|TWO_SIDED|95.0|1.06|1.56|||Regression, Logistic|||||1.56|1.06|0.0103
72524231|NCT03748420|144578155|SUPERIORITY||Odds Ratio (OR)|1.03|STANDARD_ERROR_OF_MEAN|0.1166||0.7967|TWO_SIDED|95.0|0.82|1.3|||Regression, Logistic|||||1.30|0.82|0.7967
72524232|NCT03748420|144578156|SUPERIORITY||Odds Ratio (OR)|1.18|STANDARD_ERROR_OF_MEAN|0.08906||0.0589|TWO_SIDED|95.0|0.99|1.41|||Regression, Logistic|||||1.41|0.99|0.0589
72524233|NCT03748420|144578157|SUPERIORITY||Mean Difference (Net)|1.4|STANDARD_ERROR_OF_MEAN|1.0871||0.21|TWO_SIDED|95.0|-0.8|3.5|||Mixed Models Analysis|||||3.5|-0.8|0.21
72524234|NCT03748420|144578158|SUPERIORITY||Mean Difference (Net)|-0.2|STANDARD_ERROR_OF_MEAN|0.1234||0.2|TWO_SIDED|95.0|-0.4|0.1|||Mixed Models Analysis|||||0.1|-0.4|0.20
72524235|NCT03748420|144578159|SUPERIORITY||Mean Difference (Net)|-7.47|STANDARD_ERROR_OF_MEAN|59.96||0.901|TWO_SIDED|95.0|-124.99|110.04|||Mixed Models Analysis|||||110.04|-124.99|0.901
72524236|NCT01925014|144578163|NON_INFERIORITY|Detailed in Ahn S, LOCAT Group. Trials 2014:15:28.|Risk Difference (RD)|0.013|||||TWO_SIDED|95.0|-0.008|0.033|||||The non-inferiority was established.|Detailed in Ahn S, LOCAT Group. Trials 2014:15:28.||0.033|-0.008|
72524237|NCT01925014|144578164|NON_INFERIORITY|Detailed in Ahn S, LOCAT Group. Trials 2014:15:28.|Risk Difference (RD)|0.035|||||TWO_SIDED|95.0|-0.021|0.091|||||The non-inferiority was established.|Detailed in Ahn S, LOCAT Group. Trials 2014:15:28.||0.091|-0.021|
72524238|NCT01487863|144578183|SUPERIORITY|||||||0.2141|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank-sum test.||||||0.2141
72524239|NCT00893763|144578209|SUPERIORITY_OR_OTHER|||||||0.1763|TWO_SIDED||||||mixed effects linear model|||We compared groups in a single analytical model using a mixed effects linear model with CPIS as the response variable. For this model, group (CHX, control), day, group by day interaction, APACHE III score and hospital (VCU, USF) were modeled as fixed effects and subject was modeled as a random effect.||||0.1763
72524240|NCT00893763|144578209|SUPERIORITY_OR_OTHER|||||||0.8656|TWO_SIDED||||||Regression, Logistic|||A logistic regression analysis was performed using the binary response variable of colonization or no colonization and dependent variables for group, length of intubation, and group-by-length-of-intubation interaction. The probability of a type 1 error ( a ) was set to 0.05.||||0.8656
72524241|NCT02044367|144578213|NON_INFERIORITY_OR_EQUIVALENCE|The sample size determination was not based on a power calculation, but to assure a precise estimation of the relative bioavailability. For this 3-way crossover trial, a precision (defined by ratio of upper CI limit to adjusted GMR) of at most 1.17 had been considered necessary and sufficient by the project team.|gMean Ratio T1/R (%)|137.01|STANDARD_DEVIATION|26.8|||TWO_SIDED|90.0|125.773|149.25|||||The standard deviation is actually the intra-individual geometric coefficient of variation (gCV).|Analysis of variance (ANOVA) on the logarithmic scale was used including effects for 'sequence', 'period' and 'treatment' as fixed effects and 'subjects within sequences' as random effect. CIs were calculated based on the residual error from ANOVA.||149.250|125.773|
72524242|NCT02044367|144578213|NON_INFERIORITY_OR_EQUIVALENCE|The sample size determination was not based on a power calculation, but to assure a precise estimation of the relative bioavailability. For this 3-way crossover trial, a precision (defined by ratio of upper CI limit to adjusted GMR) of at most 1.17 had been considered necessary and sufficient by the project team.|gMean Ratio T2/R (%)|130.43|STANDARD_DEVIATION|27.1|||TWO_SIDED|90.0|119.628|142.2|||||The standard deviation is actually the intra-individual geometric coefficient of variation (gCV).|Analysis of variance (ANOVA) on the logarithmic scale was used including effects for 'sequence', 'period' and 'treatment' as fixed effects and 'subjects within sequences' as random effect. CIs were calculated based on the residual error from ANOVA.||142.200|119.628|
72524243|NCT02044367|144578214|NON_INFERIORITY_OR_EQUIVALENCE|The sample size determination was not based on a power calculation, but to assure a precise estimation of the relative bioavailability. For this 3-way crossover trial, a precision (defined by ratio of upper CI limit to adjusted GMR) of at most 1.17 had been considered necessary and sufficient by the project team.|gMean Ratio T1/R (%)|146.16|STANDARD_DEVIATION|31.6|||TWO_SIDED|90.0|132.217|161.576|||||The standard deviation is actually the intra-individual geometric coefficient of variation (gCV).|Analysis of variance (ANOVA) on the logarithmic scale was used including effects for 'sequence', 'period' and 'treatment' as fixed effects and 'subjects within sequences' as random effect. CIs were calculated based on the residual error from ANOVA.||161.576|132.217|
72406455|NCT02942017|144321622|SUPERIORITY||LS Mean Difference|-0.52|STANDARD_ERROR_OF_MEAN|0.171||0.003|TWO_SIDED|95.0|-0.86|-0.18|||MMRM|||Anxiety Psychic, Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.18|-0.86|0.0030
72406456|NCT02942017|144321622|SUPERIORITY||LS Mean Difference|-0.28|STANDARD_ERROR_OF_MEAN|0.177||0.1116|TWO_SIDED|95.0|-0.63|0.07|||MMRM|||Anxiety Psychic, Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.07|-0.63|0.1116
72406457|NCT02942017|144321622|SUPERIORITY||LS Mean Difference|-0.51|STANDARD_ERROR_OF_MEAN|0.173||0.004|TWO_SIDED|95.0|-0.86|-0.17|||MMRM|||Anxiety Psychic, Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.17|-0.86|0.0040
72406458|NCT02942017|144321622|SUPERIORITY||LS Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.244||0.8253|TWO_SIDED|95.0|-0.54|0.43|||MMRM|||Anxiety Psychic, Day 14 : MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.43|-0.54|0.8253
72406459|NCT02942017|144321622|SUPERIORITY||LS Mean Difference|0.12|STANDARD_ERROR_OF_MEAN|0.209||0.5795|TWO_SIDED|95.0|-0.3|0.53|||MMRM|||Anxiety Psychic, Day 21 : MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.53|-0.30|0.5795
72406460|NCT02942017|144321622|SUPERIORITY||LS Mean Difference|0.15|STANDARD_ERROR_OF_MEAN|0.182||0.4032|TWO_SIDED|95.0|-0.21|0.51|||MMRM|||Anxiety Psychic, Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.51|-0.21|0.4032
72406461|NCT02942017|144321622|SUPERIORITY||LS Mean Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.133||0.6117|TWO_SIDED|95.0|-0.33|0.2|||MMRM|||Anxiety Somatic, Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.20|-0.33|0.6117
72406462|NCT02942017|144321622|SUPERIORITY||LS Mean Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.13||0.4716|TWO_SIDED|95.0|-0.35|0.16|||MMRM|||Anxiety Somatic, Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.16|-0.35|0.4716
72524244|NCT02044367|144578214|NON_INFERIORITY_OR_EQUIVALENCE|The sample size determination was not based on a power calculation, but to assure a precise estimation of the relative bioavailability. For this 3-way crossover trial, a precision (defined by ratio of upper CI limit to adjusted GMR) of at most 1.17 had been considered necessary and sufficient by the project team.|gMean Ratio T2/R (%)|141.06|STANDARD_DEVIATION|31.5|||TWO_SIDED|90.0|127.644|155.876|||||The standard deviation is actually the intra-individual geometric coefficient of variation (gCV).|Analysis of variance (ANOVA) on the logarithmic scale was used including effects for 'sequence', 'period' and 'treatment' as fixed effects and 'subjects within sequences' as random effect. CIs were calculated based on the residual error from ANOVA.||155.876|127.644|
72524245|NCT02044367|144578215|NON_INFERIORITY_OR_EQUIVALENCE|The sample size determination was not based on a power calculation, but to assure a precise estimation of the relative bioavailability. For this 3-way crossover trial, a precision (defined by ratio of upper CI limit to adjusted GMR) of at most 1.17 had been considered necessary and sufficient by the project team.|gMean Ratio T1/R (%)|137.61|STANDARD_DEVIATION|26.5|||TWO_SIDED|90.0|126.418|149.797|||||The standard deviation is actually the intra-individual geometric coefficient of variation (gCV).|Analysis of variance (ANOVA) on the logarithmic scale was used including effects for 'sequence', 'period' and 'treatment' as fixed effects and 'subjects within sequences' as random effect. CIs were calculated based on the residual error from ANOVA.||149.797|126.418|
72406463|NCT02942017|144321622|SUPERIORITY||LS Mean Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.136||0.6041|TWO_SIDED|95.0|-0.34|0.2|||MMRM|||Anxiety Somatic, Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.20|-0.34|0.6041
72406464|NCT02942017|144321622|SUPERIORITY||LS Mean Difference|-0.27|STANDARD_ERROR_OF_MEAN|0.132||0.0424|TWO_SIDED|95.0|-0.53|-0.01|||MMRM|||Anxiety Somatic, Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.01|-0.53|0.0424
72524246|NCT02044367|144578215|NON_INFERIORITY_OR_EQUIVALENCE|The sample size determination was not based on a power calculation, but to assure a precise estimation of the relative bioavailability. For this 3-way crossover trial, a precision (defined by ratio of upper CI limit to adjusted GMR) of at most 1.17 had been considered necessary and sufficient by the project team.|gMean Ratio T2/R (%)|132.0|STANDARD_DEVIATION|28.0|||TWO_SIDED|90.0|120.714|144.342|||||The standard deviation is actually the intra-individual geometric coefficient of variation (gCV).|Analysis of variance (ANOVA) on the logarithmic scale was used including effects for 'sequence', 'period' and 'treatment' as fixed effects and 'subjects within sequences' as random effect. CIs were calculated based on the residual error from ANOVA.||144.342|120.714|
72524247|NCT02044367|144578216|NON_INFERIORITY_OR_EQUIVALENCE|The sample size determination was not based on a power calculation, but to assure a precise estimation of the relative bioavailability. For this 3-way crossover trial, a precision (defined by ratio of upper CI limit to adjusted GMR) of at most 1.17 had been considered necessary and sufficient by the project team.|gMean Ratio T1/R (%)|147.8|STANDARD_DEVIATION|32.4|||TWO_SIDED|90.0|133.384|163.779|||||The standard deviation is actually the intra-individual geometric coefficient of variation (gCV).|Analysis of variance (ANOVA) on the logarithmic scale was used including effects for 'sequence', 'period' and 'treatment' as fixed effects and 'subjects within sequences' as random effect. CIs were calculated based on the residual error from ANOVA.||163.779|133.384|
72524248|NCT02044367|144578216|NON_INFERIORITY_OR_EQUIVALENCE|The sample size determination was not based on a power calculation, but to assure a precise estimation of the relative bioavailability. For this 3-way crossover trial, a precision (defined by ratio of upper CI limit to adjusted GMR) of at most 1.17 had been considered necessary and sufficient by the project team.|gMean Ratio T2/R (%)|144.8|STANDARD_DEVIATION|32.0|||TWO_SIDED|90.0|130.853|160.242|||||The standard deviation is actually the intra-individual geometric coefficient of variation (gCV).|Analysis of variance (ANOVA) on the logarithmic scale was used including effects for 'sequence', 'period' and 'treatment' as fixed effects and 'subjects within sequences' as random effect. CIs were calculated based on the residual error from ANOVA.||160.242|130.853|
72524249|NCT03489850|144578221|SUPERIORITY||Parameter Estimate|0.34|STANDARD_ERROR_OF_MEAN|0.69||0.62|TWO_SIDED|95.0|-1.01|1.69|||Generalized Estimating Equation|||||1.69|-1.01|.62
72524250|NCT03489850|144578222|SUPERIORITY||Odds Ratio (OR)|0.55|||<|0.05|TWO_SIDED|95.0|0.3|0.98|||Generalized Estimating Equation|||||.98|.30|<0.05
72524251|NCT03489850|144578223|SUPERIORITY||Odds Ratio (OR)|0.83|||<|0.05|TWO_SIDED|95.0|0.47|1.48|||Generalized Estimating Equation|||||1.48|0.47|<0.05
72524252|NCT03489850|144578224|SUPERIORITY||F|7.36|||<|0.05|TWO_SIDED||||||ANCOVA|||||||<0.05
72524253|NCT03787095|144578283|SUPERIORITY|||||||0.71|||||||t-test, 2 sided|||Null hypothesis: There is no change from baseline to post-baseline among participants treated with Cemiplimab. Per the analysis plan, only participants in the Cemiplimab arm are evaluated.||||0.71
72524254|NCT03787095|144578284|SUPERIORITY|||||||1|||||||t-test, 2 sided|||Null hypothesis: There is no change from baseline to post-baseline among participants treated with Cemiplimab. Per the analysis plan, only participants in the Cemiplimab arm are evaluated.||||1.00
72524255|NCT03787095|144578285|SUPERIORITY|||||||0.33|||||||t-test, 2 sided|||Null hypothesis: There is no change from baseline to post-baseline among participants treated with Cemiplimab. Per the analysis plan, only participants in the Cemiplimab arm are evaluated.||||0.33
72524256|NCT02092324|144578288|SUPERIORITY|1-proportion test for greater than 10% difference.||||||0.002||||||p-value for Protocol-defined objective response|binomial|||Proportion estimated using Clopper-Pearson method. P-value is one-sided proportion test for greater than 10% response rate (based on Simon's 2-stage).||||0.002
72524257|NCT02092324|144578288|SUPERIORITY|1-proportion test for greater than 10% difference||||||0.9||||||p-value is for IWG-defined objective response|binomial|||Proportion estimated using Clopper-Pearson method. P-value is one-sided proportion test for greater than 10% response rate (based on Simon's 2-stage).||||0.90
72524258|NCT02092324|144578291|SUPERIORITY|Proportion estimated using Clopper-Pearson method. P-value is one-sided proportion test for greater than 10% response rate.|||||<|0.0001||||||p-value for protocol-defined objective response. p-value for IWG-defined objective response is 0.70|Clopper-Pearson method|||||||<0.0001
72524259|NCT02092324|144578291|SUPERIORITY|Proportion estimated using Clopper-Pearson method. P-value is one-sided proportion test for greater than 10% response rate.||||||0.7||||||p-value for IWG-defined objective response|Clopper-Pearson method|||||||0.70
72524260|NCT02092324|144578301|EQUIVALENCE|2-sample test for equality of proportions with continuity correction (Pearson's chi-square test statistic)||||||0.003||||||p-value for protocol-defined objective response.|Chi-squared, Corrected|||2-sample test for equality of proportions with continuity correction (Pearson's chi-square test statistic) comparing Wildtype and Mutant CSF3R status for protocol-defined objective response||||0.003
72524261|NCT02092324|144578301|EQUIVALENCE|2-sample test for equality of proportions with continuity correction (Pearson's chi-square)||||||0.1||||||p-value for IWG-defined objective response = 0.1|Fisher Exact|||2-sample test for equality of proportions with continuity correction (Pearson's chi-square test statistic) comparing Wildtype and Mutant CSF3R status for IWG-defined objective response||||0.1
72570923|NCT00824616|144670236|SUPERIORITY_OR_OTHER||Proportions|5.9||||0.537|TWO_SIDED|95.0|-13.7|25.4|||Miettinen & Nurminen method|||Between-treatment difference (MK-0941 group minus Placebo group) in the percentage of participants who experienced one or more episodes of hypoglycemia.||25.4|-13.7|0.537
72524262|NCT00441012|144578342|SUPERIORITY_OR_OTHER||Percentage of Seroprotected Participants|100.0||||||95.0|98.7|100.0|||||Exact binomial confidence interval|The purpose of the primary analysis is to demonstrate that there is an adequate seroprotection rate (percentage of participants with anti-HBs \>=10mIU/mL) in each group at 1 month after the third dose. An adequate response requires the lower bound of the two-sided 95% confidence interval for the seroprotection rate to exceed 90%.||100.0|98.7|
72524263|NCT00441012|144578342|SUPERIORITY_OR_OTHER||Percentage of Seroprotected Participants|99.1||||||95.0|69.9|99.9|||||Exact binomial confidence interval|The purpose of the primary analysis is to demonstrate that there is an adequate seroprotection rate (percentage of participants with anti-HBs \>=10mIU/mL) in each group at 1 month after the third dose. An adequate response requires the lower bound of the two-sided 95% confidence interval for the seroprotection rate to exceed 90%.||99.9|69.9|
72524264|NCT00441012|144578343|NON_INFERIORITY_OR_EQUIVALENCE|The Modified Process Vaccine is non-inferior to COMVAX with respect to anti-HBs GMT. The non-inferiority criterion requires that the lower bound of the two-sided 95% confidence interval on the ratio of the Month 11 GMTs \[GMT modified process vaccine/GMT COMVAX™\] is \>0.67.|Geometric Mean Titer Ratio|2.5||||||95.0|1.9|3.3||||||||3.3|1.9|
72524265|NCT00441012|144578345|SUPERIORITY_OR_OTHER||Percentage of Seroprotected Participants|93.9||||||95.0|90.0|96.6|||||Exact binomial confidence interval|||96.6|90.0|
72570924|NCT01276301|144670239|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability|Geometric Mean Ratio|102.95|STANDARD_ERROR_OF_MEAN|6.5|||TWO_SIDED|90.0|98.87|107.02|||ANOVA|Based on ANOVA with fixed terms for sequence, period, treatment and random term for subject within sequence.|Standard error of the mean is actually the Intra-Individual geometric coefficient of variation (gCV).|Ratio calculated as empa plus verapamil divided by empa||107.02|98.87|
72570925|NCT01276301|144670240|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability|Geometric Mean Ratio|92.39|STANDARD_ERROR_OF_MEAN|12.7|||TWO_SIDED|90.0|85.38|99.97|||ANOVA|Based on ANOVA with fixed terms for sequence, period, treatment and random term for subject within sequence.|Standard error of the mean is actually the Intra-Individual geometric coefficient of variation (gCV).|Ratio calculated as empa plus verapamil divided by empa||99.97|85.38|
72570926|NCT01276301|144670241|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability|Geometric Mean Ratio|102.77|STANDARD_ERROR_OF_MEAN|6.2|||TWO_SIDED|90.0|98.87|106.83|||ANOVA|Based on ANOVA with fixed terms for sequence, period, treatment and random term for subject within sequence.|Standard error of the mean is actually the Intra-Individual geometric coefficient of variation (gCV).|Ratio calculated as empa plus verapamil divided by empa||106.83|98.87|
72570927|NCT04870138|144670269|OTHER|||||||1||||||One-sided Fisher's Exact Test with alpha = 0.05|Fisher Exact|||||||1.000
72570928|NCT04870138|144670271|OTHER||||||<|0.0001|||||||t-test, 1 sided|One-sided single sample t-test with alpha=0.05||Null hypothesis: The proportion of the strain in the inoculum = 0.5||||<0.0001
72570929|NCT03167723|144670321|NON_INFERIORITY|15% Non-Inferiority||||||0.036|||||||Farrington-Manning|||||||0.036
72570930|NCT04647721|144670359|NON_INFERIORITY|Non-inferiority margin of 0.5. The two-sided 95% confidence interval (CI) for the treatment difference was constructed using the repeated-measures analysis of covariance (ANCOVA).|Difference in Least Squares Means|0.03|||||TWO_SIDED|95.0|-0.07|0.12||||||||0.12|-0.07|
72570931|NCT04647721|144670360|OTHER||Risk Difference (RD)|0.0|||||TWO_SIDED|95.0|-6.35|6.35||||||||6.35|-6.35|
72570932|NCT04647721|144670361|OTHER||Risk Difference (RD)|1.75|||||TWO_SIDED|95.0|-3.08|6.74||||||||6.74|-3.08|
72570933|NCT05070546|144670368|NON_INFERIORITY|Non-inferiority of Cohort 3 (Group 5) versus Cohorts 1 (Group 1) and 2 (Group 3) in terms of RSV A2 Strain neutralizing antibody titers against 14 days after vaccination, using a non-inferiority margin of 0.67 for the GMT ratio (Cohort 3 \[Group 5\]/Cohort 1\[Group1\] and 2 \[Group 3\])|Geometric Mean Ratio|1.41|||||TWO_SIDED|95.0|1.25|1.6|||Geometric Mean Ratio|||||1.60|1.25|
72570934|NCT05070546|144670368|NON_INFERIORITY|Non-inferiority of Cohort 3 (Group 5) versus Cohort 2 (Group 3 in terms of RSV A2 Strain neutralizing antibody titers against 14 days after vaccination, using a non-inferiority margin of 0.67 for the GMT ratio (Cohort 3 \[Group 5\]/Cohort 2 \[Group 3\])|Geometric mean ratio|1.54|||||TWO_SIDED|95.0|1.34|1.78|||Geometric Mean Ratio|||||1.78|1.34|
72625184|NCT01098747|144780078|SUPERIORITY_OR_OTHER||LS mean difference|2.02|||<|0.001|TWO_SIDED|95.0|1.58|2.45||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||4 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS mean from the ANOVA model.||2.45|1.58|<0.001
72570935|NCT05070546|144670369|NON_INFERIORITY|Non-inferiority of Cohort 3 (Group 5) versus Cohorts 1 (Group 1) and 2 (Group 3) in terms of RSV A2 Strain neutralizing antibody titers against 14 days after vaccination, using a non-inferiority margin of -10% for the GMT ratio (Cohort 3 \[Group 5\]/Cohort 1\[Group1\] and 2 \[Group 3\]).|Difference in Seroresponse rate|5.4|||||TWO_SIDED|95.0|0.3|10.9|||Difference in Seroresponse rate|||||10.9|0.3|
72570936|NCT05070546|144670369|NON_INFERIORITY|Non-inferiority of Cohort 3 (Group 5) versus Cohorts 1 (Group 1) and 2 (Group 3) in terms of RSV A2 Strain neutralizing antibody titers against 14 days after vaccination, using a non-inferiority margin of -10% for the GMT ratio (Cohort 3 \[Group 5\]/Cohort 2 \[Group 3\]).|Difference in Seroresponse rate|4.4|||||TWO_SIDED|95.0|-1.6|10.5|||Difference in Seroresponse rate|||||10.5|-1.6|
72570937|NCT00535587|144670371|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.05|STANDARD_DEVIATION|2.94|<|0.02|TWO_SIDED|95.0|||||ANCOVA|||||||<0.02
72570938|NCT00546572|144670399|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 2-sided 95 % confidence interval for the geometric mean ratio (GMR) was \> 0.5 (2-fold criterion). Statistical significance demonstrated if the lower limit of the 2-sided 95 % confidence interval for the geometric mean ratio (GMR) was \> 1.|ratio of geometric mean titer|1.5|||||TWO_SIDED|95.0|1.17|1.88|||||Confidence intervals for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS).|Serotype 1: ratio of GMT (13vPnC to 23vPS) calculated by back transforming the mean difference between vaccine groups on the logarithmic scale.||1.88|1.17|
72570939|NCT00546572|144670399|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 2-sided 95 % confidence interval for the geometric mean ratio (GMR) was \> 0.5 (2-fold criterion). Statistical significance demonstrated if the lower limit of the 2-sided 95 % confidence interval for the geometric mean ratio (GMR) was \> 1.|ratio of geometric mean titer|1.1|||||TWO_SIDED|95.0|0.91|1.35|||||Confidence intervals for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS).|Serotype 3: ratio of GMT (13vPnC to 23vPS) calculated by back transforming the mean difference between vaccine groups on the logarithmic scale.||1.35|0.91|
72524266|NCT00441012|144578345|SUPERIORITY_OR_OTHER||Percentage of Seroprotected Participants|92.1||||||95.0|87.8|95.3|||||Exact binomial confidence interval|No hypothesis is being tested. The purpose of the secondary analysis is to estimate the seroprotection rate (percentage of participants with anti-PRP \> 1µg/mL) in each group at 1 month after the third dose.||95.3|87.8|
72406465|NCT02942017|144321622|SUPERIORITY||LS Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.138||0.7622|TWO_SIDED|95.0|-0.32|0.23|||MMRM|||Anxiety Somatic, Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.23|-0.32|0.7622
72406466|NCT02942017|144321622|SUPERIORITY||LS Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.13||0.2689|TWO_SIDED|95.0|-0.4|0.11|||MMRM|||Anxiety Somatic, Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.11|-0.40|0.2689
72406467|NCT02942017|144321622|SUPERIORITY||LS Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.134||0.211|TWO_SIDED|95.0|-0.44|0.1|||MMRM|||Anxiety Somatic, Hour 48 : MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.10|-0.44|0.2110
72406468|NCT02942017|144321622|SUPERIORITY||LS Mean Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.135||0.5873|TWO_SIDED|95.0|-0.34|0.2|||MMRM|||Anxiety Somatic, Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.20|-0.34|0.5873
72406469|NCT02942017|144321622|SUPERIORITY||LS Mean Difference|-0.23|STANDARD_ERROR_OF_MEAN|0.114||0.045|TWO_SIDED|95.0|-0.46|-0.01|||MMRM|||Anxiety Somatic, Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.01|-0.46|0.0450
72406470|NCT02942017|144321622|SUPERIORITY||LS Mean Difference|-0.26|STANDARD_ERROR_OF_MEAN|0.152||0.0847|TWO_SIDED|95.0|-0.57|0.04|||MMRM|||Anxiety Somatic, Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.04|-0.57|0.0847
72524267|NCT00997555|144578360|SUPERIORITY_OR_OTHER|||||||0.6||95.0|||||Chi-squared|||||||0.6
72524268|NCT00997555|144578361|SUPERIORITY_OR_OTHER|||||||0.7||95.0||||(bronchoscopy 5.1 days, 95% CI +/- 3.6 days versus control 6.7 days, 95% CI +/- 6.3 days, p = 0.7).|t-test, 2 sided|||||||0.7
72524269|NCT00997555|144578362|SUPERIORITY_OR_OTHER|||||||0.4||95.0|||||t-test, 2 sided|(bronchoscopy 10 days, 95% CI +/- 10 days versus control 18 days, 95% CI +/- 12 days, p = 0.4).||||||0.4
72625185|NCT01098747|144780078|SUPERIORITY_OR_OTHER||LS mean difference|-0.23||||0.151|TWO_SIDED|95.0|-0.54|0.08||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||4 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS mean from the ANOVA model.||0.08|-0.54|0.151
72625186|NCT01098747|144780078|SUPERIORITY_OR_OTHER||LS mean difference|1.88|||<|0.001|TWO_SIDED|95.0|1.43|2.33||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||5 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS mean from the ANOVA model.||2.33|1.43|<0.001
72406471|NCT02942017|144321622|SUPERIORITY||LS Mean Difference|0.22|STANDARD_ERROR_OF_MEAN|0.189||0.2522|TWO_SIDED|95.0|-0.16|0.6|||MMRM|||Anxiety Somatic, Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.60|-0.16|0.2522
72524270|NCT00997555|144578363|SUPERIORITY_OR_OTHER|||||||0.5||95.0|||||t-test, 2 sided|(bronchoscopy 21 days, 95% CI +/- 12 days versus control 26 days, 95% CI +/- 12 days, p = 0.5).||||||0.5
72524271|NCT03028467|144578392|OTHER||Mean Difference (Net)|-1.111|||||TWO_SIDED|95.0|-2.7186|0.4965|||||Week 1. The analysis method was mixed-model for repeated measures with Visit,Treatment group,Visit by Treatment interaction,Baseline DAS28(CRP),and Visit by Baseline DAS28(CRP) interaction as fixed effects.|||0.4965|-2.7186|
72524272|NCT03028467|144578392|OTHER||Mean Difference (Net)|-0.5177|||||TWO_SIDED|95.0|-1.904|0.8685|||||Week 1. The analysis method was mixed-model for repeated measures with Visit,Treatment group,Visit by Treatment interaction,Baseline DAS28(CRP),and Visit by Baseline DAS28(CRP) interaction as fixed effects.|||0.8685|-1.9040|
72524273|NCT03028467|144578392|OTHER||Mean Difference (Net)|-0.5332|||||TWO_SIDED|95.0|-1.914|0.8475|||||Week 1. The analysis method was mixed-model for repeated measures with Visit,Treatment group,Visit by Treatment interaction,Baseline DAS28(CRP),and Visit by Baseline DAS28(CRP) interaction as fixed effects.|||0.8475|-1.9140|
72524274|NCT03028467|144578392|OTHER||Mean Difference (Net)|-1.1387|||||TWO_SIDED|95.0|-2.8848|0.6075|||||Week 2. The analysis method was mixed-model for repeated measures with Visit,Treatment group,Visit by Treatment interaction,Baseline DAS28(CRP),and Visit by Baseline DAS28(CRP) interaction as fixed effects.|||0.6075|-2.8848|
72524275|NCT03028467|144578392|OTHER||Mean Difference (Net)|-0.8905|||||TWO_SIDED|95.0|-2.3962|0.6153|||||Week 2. The analysis method was mixed-model for repeated measures with Visit,Treatment group,Visit by Treatment interaction,Baseline DAS28(CRP),and Visit by Baseline DAS28(CRP) interaction as fixed effects.|||0.6153|-2.3962|
72524276|NCT03028467|144578392|OTHER||Mean Difference (Net)|-0.8047|||||TWO_SIDED|95.0|-2.3045|0.6951|||||Week 2. The analysis method was mixed-model for repeated measures with Visit,Treatment group,Visit by Treatment interaction,Baseline DAS28(CRP),and Visit by Baseline DAS28(CRP) interaction as fixed effects.|||0.6951|-2.3045|
72524277|NCT03028467|144578392|OTHER||Mean Difference (Net)|-1.4575|||||TWO_SIDED|95.0|-3.6013|0.6863|||||Week 4. The analysis method was mixed-model for repeated measures with Visit,Treatment group,Visit by Treatment interaction,Baseline DAS28(CRP),and Visit by Baseline DAS28(CRP) interaction as fixed effects.|||0.6863|-3.6013|
72524278|NCT03028467|144578392|OTHER||Mean Difference (Net)|-0.8894|||||TWO_SIDED|95.0|-2.7381|0.9593|||||Week 4. The analysis method was mixed-model for repeated measures with Visit,Treatment group,Visit by Treatment interaction,Baseline DAS28(CRP),and Visit by Baseline DAS28(CRP) interaction as fixed effects.|||0.9593|-2.7381|
72524279|NCT03028467|144578392|OTHER||Mean Difference (Net)|-1.1615|||||TWO_SIDED|95.0|-3.0028|0.6799|||||Week 4. The analysis method was mixed-model for repeated measures with Visit,Treatment group,Visit by Treatment interaction,Baseline DAS28(CRP),and Visit by Baseline DAS28(CRP) interaction as fixed effects.|||0.6799|-3.0028|
72524280|NCT03028467|144578392|OTHER||Mean Difference (Net)|-0.3209|||||TWO_SIDED|95.0|-2.3021|1.6603|||||Week 6. The analysis method was mixed-model for repeated measures with Visit,Treatment group,Visit by Treatment interaction,Baseline DAS28(CRP),and Visit by Baseline DAS28(CRP) interaction as fixed effects.|||1.6603|-2.3021|
72524281|NCT03028467|144578392|OTHER||Mean Difference (Net)|-0.1876|||||TWO_SIDED|95.0|-1.896|1.5209|||||Week 6. The analysis method was mixed-model for repeated measures with Visit,Treatment group,Visit by Treatment interaction,Baseline DAS28(CRP),and Visit by Baseline DAS28(CRP) interaction as fixed effects.|||1.5209|-1.8960|
72524282|NCT03028467|144578392|OTHER||Mean Difference (Net)|-0.4593|||||TWO_SIDED|95.0|-2.161|1.2424|||||Week 6. The analysis method was mixed-model for repeated measures with Visit,Treatment group,Visit by Treatment interaction,Baseline DAS28(CRP),and Visit by Baseline DAS28(CRP) interaction as fixed effects.|||1.2424|-2.1610|
72524283|NCT03028467|144578392|OTHER||Mean Difference (Net)|-0.6521|||||TWO_SIDED|95.0|-3.1342|1.83|||||Week 8. The analysis method was mixed-model for repeated measures with Visit,Treatment group,Visit by Treatment interaction,Baseline DAS28(CRP),and Visit by Baseline DAS28(CRP) interaction as fixed effects.|||1.8300|-3.1342|
72524284|NCT03028467|144578392|OTHER||Mean Difference (Net)|-0.5499|||||TWO_SIDED|95.0|-2.6903|1.5904|||||Week 8. The analysis method was mixed-model for repeated measures with Visit,Treatment group,Visit by Treatment interaction,Baseline DAS28(CRP),and Visit by Baseline DAS28(CRP) interaction as fixed effects.|||1.5904|-2.6903|
72524285|NCT03028467|144578392|OTHER||Mean Difference (Net)|-0.9665|||||TWO_SIDED|95.0|-3.0984|1.1654|||||Week 8. The analysis method was mixed-model for repeated measures with Visit,Treatment group,Visit by Treatment interaction,Baseline DAS28(CRP),and Visit by Baseline DAS28(CRP) interaction as fixed effects.|||1.1654|-3.0984|
72524286|NCT03028467|144578392|OTHER||Mean Difference (Net)|-0.3576|||||TWO_SIDED|95.0|-3.0892|2.374|||||Week 12. The analysis method was mixed-model for repeated measures with Visit,Treatment group,Visit by Treatment interaction,Baseline DAS28(CRP),and Visit by Baseline DAS28(CRP) interaction as fixed effects.|||2.3740|-3.0892|
72570940|NCT00546572|144670399|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 2-sided 95 % confidence interval for the geometric mean ratio (GMR) was \> 0.5 (2-fold criterion). Statistical significance demonstrated if the lower limit of the 2-sided 95 % confidence interval for the geometric mean ratio (GMR) was \> 1.|ratio of geometric mean titer|2.7|||||TWO_SIDED|95.0|1.93|3.74|||||Confidence intervals for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS).|Serotype 4: ratio of GMT (13vPnC to 23vPS) calculated by back transforming the mean difference between vaccine groups on the logarithmic scale.||3.74|1.93|
72524287|NCT03028467|144578392|OTHER||Mean Difference (Net)|0.1851|||||TWO_SIDED|95.0|-2.1704|2.5407|||||Week 12. The analysis method was mixed-model for repeated measures with Visit,Treatment group,Visit by Treatment interaction,Baseline DAS28(CRP),and Visit by Baseline DAS28(CRP) interaction as fixed effects.|||2.5407|-2.1704|
72524288|NCT03028467|144578392|OTHER||Mean Difference (Net)|-0.1181|||||TWO_SIDED|95.0|-2.4643|2.2281|||||Week 12. The analysis method was mixed-model for repeated measures with Visit,Treatment group,Visit by Treatment interaction,Baseline DAS28(CRP),and Visit by Baseline DAS28(CRP) interaction as fixed effects.|||2.2281|-2.4643|
72625187|NCT01098747|144780078|SUPERIORITY_OR_OTHER||LS mean difference|-0.23||||0.16|TWO_SIDED|95.0|-0.56|0.09||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||5 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS mean from the ANOVA model.||0.09|-0.56|0.160
72524289|NCT03028467|144578392|OTHER||Mean Difference (Net)|-1.4276|||||TWO_SIDED|95.0|-3.6569|0.8018|||||Week 22 (Follow up). The analysis method was mixed-model for repeated measures with Visit,Treatment group,Visit by Treatment interaction,Baseline DAS28(CRP),and Visit by Baseline DAS28(CRP) interaction as fixed effects.|||0.8018|-3.6569|
72524290|NCT03028467|144578392|OTHER||Mean Difference (Net)|0.5415|||||TWO_SIDED|95.0|-1.381|2.4639|||||Week 22 (Follow up). The analysis method was mixed-model for repeated measures with Visit,Treatment group,Visit by Treatment interaction,Baseline DAS28(CRP),and Visit by Baseline DAS28(CRP) interaction as fixed effects.|||2.4639|-1.3810|
72524291|NCT03028467|144578392|OTHER||Mean Difference (Net)|-0.7932|||||TWO_SIDED|95.0|-2.708|1.1217|||||Week 22 (Follow up). The analysis method was mixed-model for repeated measures with Visit,Treatment group,Visit by Treatment interaction,Baseline DAS28(CRP),and Visit by Baseline DAS28(CRP) interaction as fixed effects.|||1.1217|-2.7080|
72524292|NCT01387594|144578394|SUPERIORITY_OR_OTHER_LEGACY||Geometric Mean Ratio (GMR)|1.33|||||TWO_SIDED|80.0|1.13|1.56||A p-value was not computed; hypothesis was tested using confidence interval (CI) approach.|||The lower limit of 80% CI greater than 0.5 indicates the statistical significance at alpha=0.1 level.|The null hypothesis is the (median) percent decrease in total lymphocytes count is greater or equal to 50%, equivalently indicating that the geometric mean ratio (GMR: post-treatment/pretreatment) in total lymphocyte counts is less than or equal to 0.5.||1.56|1.13|
72524293|NCT00796224|144578423|SUPERIORITY_OR_OTHER||Ratio of Geometric Means|157.98||||||90.0|98.87|252.44|||ANOVA|||Test (60 mg/kg Azithromycin ER)/ Reference (30 mg/kg Azithromycin IR)||252.44|98.87|
72524294|NCT00796224|144578425|SUPERIORITY_OR_OTHER||Ratio of Geometric Means|91.63||||||90.0|56.21|149.38|||ANOVA|||||149.38|56.21|
72524295|NCT00796224|144578427|SUPERIORITY_OR_OTHER||Ratio of Geometric means (percent)|65.44||||||90.0|23.56|181.77|||ANOVA||Ratio (percent) = Test/Reference multiplied by 100|Serum Concentration 1 hour postdose||181.77|23.56|
72524296|NCT00796224|144578427|SUPERIORITY_OR_OTHER||Ratio of Geometric means (percent)|50.57||||||90.0|25.24|101.3|||ANOVA||Ratio (percent) = Test/Reference multiplied by 100|Serum Concentration 2 hours postdose||101.30|25.24|
72524297|NCT00796224|144578427|SUPERIORITY_OR_OTHER||Ratio of Geometric means (percent)|100.07||||||90.0|57.91|172.92|||ANOVA||Ratio (percent) = Test/Reference multiplied by 100|Serum Concentration 3 hours postdose||172.92|57.91|
72524298|NCT00796224|144578427|SUPERIORITY_OR_OTHER||Ratio of Geometric means (percent)|164.93||||||90.0|103.78|262.12|||ANOVA||Ratio (percent) = Test/Reference multiplied by 100|Serum Concentration 4 hours postdose||262.12|103.78|
72524299|NCT00796224|144578427|SUPERIORITY_OR_OTHER||Ratio of Geometric means (percent)|174.41||||||90.0|110.07|276.36|||ANOVA||Ratio (percent) = Test/Reference multiplied by 100|Serum Concentration 8 hours postdose||276.36|110.07|
72524300|NCT00796224|144578427|SUPERIORITY_OR_OTHER||Ratio of Geometric means (percent)|173.01||||||90.0|111.45|268.55|||ANOVA||Ratio (percent) = Test/Reference multiplied by 100|Serum Concentration 24 hours postdose||268.55|111.45|
72524301|NCT00796224|144578427|SUPERIORITY_OR_OTHER||Ratio of Geometric means (percent)|189.35||||||90.0|129.76|276.3|||ANOVA||Ratio (percent) = Test/Reference multiplied by 100|Serum Concentration 48 hours postdose||276.30|129.76|
72524302|NCT00796224|144578427|SUPERIORITY_OR_OTHER||Ratio of Geometric means (percent)|183.14||||||90.0|124.61|269.14|||ANOVA||Ratio (percent) = Test/Reference multiplied by 100|Serum Concentration 72 hours postdose||269.14|124.61|
72542542|NCT01963676|144614932|SUPERIORITY_OR_OTHER|||||||0.86|TWO_SIDED|||||There was no adjustment because we just performed one comparison|t-test, 2 sided|Difference from 1 Month to Baseline was compared between the sham and the tDCS group using an unpaired t-test. Degrees of freedom: df = 24||"The null hypothesis was that there is no difference between the AHRS score changes from baseline to 1month between the groups:~H0: μ1 = μ2 μ1: mean(difference 1 month-baseline) for tDCS group (n=13) μ2: mean(difference 1 month-baseline) for sham group (n=13)"||||0.86
72542543|NCT01246973|144614933|SUPERIORITY_OR_OTHER|||||||0.6555|TWO_SIDED||||||F-test|||||||0.6555
72625188|NCT01098747|144780078|SUPERIORITY_OR_OTHER||LS mean difference|1.63|||<|0.001|TWO_SIDED|95.0|1.16|2.1||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||6 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS mean from the ANOVA model.||2.10|1.16|<0.001
72542544|NCT01246973|144614934|SUPERIORITY_OR_OTHER|||||||0.3504|TWO_SIDED||||||Chi-squared|||||||0.3504
72542545|NCT00766506|144614935|SUPERIORITY_OR_OTHER||Least square mean difference|-2.23|||<|0.001|TWO_SIDED|95.0|-2.55|-1.91|||ANCOVA|P-value was calculated from analysis of covariance (ANCOVA), with centre, surgery type and treatment included as covariates in the analysis.|Least square mean difference = Least square mean value for Fentanyl IONSYS group minus Least square mean value for Morphine IV PCA group|||-1.91|-2.55|<0.001
72542546|NCT00766506|144614936|SUPERIORITY_OR_OTHER|||||||0.219|||||||ANCOVA|P-value was calculated from ANCOVA, with centre, surgery type and treatment included as covariates in the analysis.||At Hour 24||||0.219
72542547|NCT00766506|144614936|SUPERIORITY_OR_OTHER|||||||0.299|||||||ANCOVA|P-value was calculated from ANCOVA, with centre, surgery type and treatment included as covariates in the analysis.||At Hour 48||||0.299
72542548|NCT00766506|144614936|SUPERIORITY_OR_OTHER|||||||0.136|||||||ANCOVA|P-value was calculated from ANCOVA, with centre, surgery type and treatment included as covariates in the analysis.||At study discontinuation or withdrawal||||0.136
72542549|NCT00766506|144614937|SUPERIORITY_OR_OTHER||Least square mean difference|-0.52|||<|0.001|TWO_SIDED|95.0|-0.74|-0.3|||ANCOVA|P-value was calculated from ANCOVA, with centre, surgery type and treatment included as covariates in the analysis.|Least square mean difference = Least square mean value for Fentanyl IONSYS group minus Least square mean value for Morphine IV PCA group|||-0.30|-0.74|<0.001
72542550|NCT00766506|144614938|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.81||||0.131|TWO_SIDED|95.0|0.84|3.92|||Mantel Haenszel|P-value was calculated from a Mantel-Haenszel Chi-Squared test.||||3.92|0.84|0.131
72542551|NCT00766506|144614939|SUPERIORITY_OR_OTHER|||||||0.342|||||||Log Rank|P-value was calculated from a log-rank test stratified for surgery type.||||||0.342
72542552|NCT00766506|144614940|SUPERIORITY_OR_OTHER|||||||0.836|||||||Log Rank|P-value was calculated from a log-rank test stratified for surgery type.||||||0.836
72542553|NCT00766506|144614941|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.0||||0.029|TWO_SIDED|95.0|1.04|24.03|||Chi-squared|||||24.03|1.04|0.029
72542554|NCT00766506|144614943|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.61||||0.23|TWO_SIDED|95.0|0.74|3.53|||Chi-squared|||Paracetamol: P-value was calculated using Chi-squared test.||3.53|0.74|0.230
72542555|NCT00766506|144614943|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.72||||0.163|TWO_SIDED|95.0|0.8|3.7|||Chi-squared|||NSAID's: P-value was calculated using Chi-squared test.||3.70|0.80|0.163
72542556|NCT02496221|144614945|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.0021||||0.1229|TWO_SIDED|95.0|-20.5781|2.5739|||Mixed Models Analysis|Treatment (albiglutide or placebo), and period as fixed effects and participant as random effect||||2.5739|-20.5781|0.1229
72542557|NCT02496221|144614946|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-545.9585||||0.1291|TWO_SIDED|95.0|-1260.0|168.0858|||Mixed Models Analysis|||||168.0858|-1260.00|0.1291
72542558|NCT02496221|144614948|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.2992||||0.0317|TWO_SIDED|95.0|-31.0762|-1.5223|||Mixed Models Analysis|Treatment (albiglutide or placebo), and period as fixed effects and participant as random effect||||-1.5223|-31.0762|0.0317
72542559|NCT02496221|144614949|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|252.6099||||0.0291|TWO_SIDED|95.0|29.5081|475.7117|||Mixed Models Analysis|Treatment (albiglutide or placebo), and period as fixed effects and participant as random effect||||475.7117|29.5081|0.0291
72542560|NCT02496221|144614950|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3748||||0.7961|TWO_SIDED|95.0|-3.4109|2.6614|||Mixed Models Analysis|Treatment (albiglutide or placebo), and period as fixed effects and participant as random effect||||2.6614|-3.4109|0.7961
72542561|NCT02496221|144614952|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.001526||||0.9424|TWO_SIDED|95.0|-0.045665|0.048717|||Mixed Models Analysis|Treatment (albiglutide or placebo), and period as fixed effects and participant as random effect||||0.048717|-0.045665|0.9424
72406472|NCT02942017|144321622|SUPERIORITY||LS Mean Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.16||0.5026|TWO_SIDED|95.0|-0.43|0.21|||MMRM|||Anxiety Somatic, day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.21|-0.43|0.5026
72406473|NCT02942017|144321622|SUPERIORITY||LS Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.149||0.5911|TWO_SIDED|95.0|-0.38|0.22|||MMRM|||Anxiety Somatic, Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.22|-0.38|0.5911
72524303|NCT01673373|144578490|OTHER|Due to the early termination of enrollment, all inferential analyses were interpreted as descriptive and carried out in an exploratory manner.|||||<|0.0001||||||The p-value was computed using a one-sided exact test of the difference between the observed rate and the Performance Goal (equal to 70%). The defined threshold for statistical significance is .025.|one-sided exact|||The original Performance Goal of 70% patency rate was derived from a thorough literature review of trials with renal bare metal stent placement. Other assumptions included a determination of samples size based upon a one-sided alpha of 0.025 and desired power of 87%, and assumption of 10% attrition. The null hypothesis was that the incidence of primary patency at 9 months is less than or equal to 70%.|"The cumulative incidence of primary patency was computed as the number of subject-lesions with primary patency at 9 months divided by the number of subject-lesions and was analyzed using the allowable window of 243 to 303 trial days.~An exact binomial one-sided 95% CI was constructed and the lower limit compared to the Performance Goal equal to 70%."|||<.0001
72524304|NCT01673373|144578491|OTHER|A one-sided 95% Confidence Interval for the mean difference between baseline and 9-month systolic blood pressure was constructed and the lower limit compared to the 10 mmHg performance goal. A p-value of the difference between the estimated systolic blood pressure change from the baseline and the performance goal was computed using a paired t-test.||||||0.0192||||||The defined threshold for statistical significance is .025.|t-test, 1 sided|||The primary endpoint of systolic blood pressure was analyzed according to the Performance Goal of a decrease in systolic blood pressure of 10 mmHg between procedure and 9 months.||||.0192
72524305|NCT05171816|144578503|OTHER|Exploratory|Hazard Ratio (HR)|1.43||||0.2592|TWO_SIDED|95.0|0.83|2.48||Nominal p-value|Log Rank|The 2-sided p-value was calculated using the log-rank test stratified by metastases.|HR and CI calculated using Cox Proportional Hazards model, where a HR \< 1 favours olaparib+abiraterone. Stratification factors are the same as those used in the stratified log-rank test.|||2.48|0.83|0.2592
72524306|NCT05171816|144578504|OTHER|Exploratory|Hazard Ratio (HR)|1.14||||0.7251|TWO_SIDED|95.0|0.57|2.29||Nominal p-value|Log Rank|The 2-sided p-value was calculated using the log-rank test stratified by metastases.|HR and CI calculated using Cox Proportional Hazards model, where a HR \< 1 favours olaparib+abiraterone. Stratification factors are the same as those used in the stratified log-rank test.|||2.29|0.57|0.7251
72524307|NCT05171816|144578505|OTHER|Exploratory|Hazard Ratio (HR)|0.99||||0.9715|TWO_SIDED|95.0|0.6|1.64||Nominal p-value|Log Rank|The 2-sided p-value was calculated using the log-rank test stratified by metastases.|HR and CI calculated using Cox Proportional Hazards model, where a HR \< 1 favours olaparib+abiraterone. Stratification factors are the same as those used in the stratified log-rank test.|||1.64|0.60|0.9715
72406474|NCT02942017|144321622|SUPERIORITY||LS Mean Difference|0.07|STANDARD_ERROR_OF_MEAN|0.122||0.58|TWO_SIDED|95.0|-0.18|0.31|||MMRM|||Somatic Symptoms Gastrointestinal, Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.31|-0.18|0.5800
72406475|NCT02942017|144321622|SUPERIORITY||LS Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.129||0.6754|TWO_SIDED|95.0|-0.31|0.2|||MMRM|||Somatic Symptoms Gastrointestinal, Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.20|-0.31|0.6754
72524308|NCT05171816|144578506|OTHER|Exploratory|Hazard Ratio (HR)|0.68||||0.4937|TWO_SIDED|95.0|0.2|2.06||Nominal p-value|Log Rank|The 2-sided p-value was calculated using the log-rank test stratified by metastases.|HR and CI calculated using Cox Proportional Hazards model, where a HR \< 1 favours olaparib+abiraterone. Stratification factors are the same as those used in the stratified log-rank test.|||2.06|0.20|0.4937
72524309|NCT05171816|144578507|OTHER|Exploratory|Hazard Ratio (HR)|1.65||||0.4923|TWO_SIDED|95.0|0.61|4.87||Nominal p-value|Log Rank|The 2-sided p-value was calculated using the log-rank test stratified by metastases.|HR and CI calculated using Cox Proportional Hazards model, where a HR \< 1 favours olaparib+abiraterone. Stratification factors are the same as those used in the stratified log-rank test.|||4.87|0.61|0.4923
72524310|NCT05171816|144578509|OTHER|Exploratory|Hazard Ratio (HR)|1.45||||0.3407|TWO_SIDED|95.0|0.63|3.39||Nominal p-value|Log Rank|The 2-sided p-value was calculated using the log-rank test stratified by metastases.|HR and CI calculated using Cox Proportional Hazards model, where a HR \< 1 favours olaparib+abiraterone. Stratification factors are the same as those used in the stratified log-rank test.|||3.39|0.63|0.3407
72524311|NCT02000622|144578531|SUPERIORITY||Hazard Ratio (HR)|0.58||||0.0009|TWO_SIDED|95.0|0.43|0.8||A priori threshold for statistical significance (2-sided) is 0.05.|Log Rank|Stratified by received prior chemotherapy for metastatic breast cancer (yes/no) and receptor status.|Hazard ratio \<1 favours olaparib.|Study is sized to provide 90% power to detect a true treatment effect of PFS hazard ratio 0.653.||0.80|0.43|0.0009
72524312|NCT02000622|144578532|SUPERIORITY||Hazard Ratio (HR)|0.57||||0.0033|TWO_SIDED|95.0|0.4|0.83||PFS2 tested using a multiple testing procedure with a recycling strategy. With 157 PFS2 events, a priori threshold for statistical significance (2-sided) was 0.008.|Log Rank|Stratified by received prior chemotherapy for metastatic breast cancer (yes/no) and receptor status.|Hazard ratio \<1 favours olaparib.|||0.83|0.40|0.0033
72406476|NCT02942017|144321622|SUPERIORITY||LS Mean Difference|0.19|STANDARD_ERROR_OF_MEAN|0.116||0.1006|TWO_SIDED|95.0|-0.04|0.42|||MMRM|||Somatic Symptoms Gastrointestinal, Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.42|-0.04|0.1006
72406477|NCT02942017|144321622|SUPERIORITY||LS Mean Difference|0.11|STANDARD_ERROR_OF_MEAN|0.12||0.3588|TWO_SIDED|95.0|-0.13|0.35|||MMRM|||Somatic Symptoms Gastrointestinal, Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.35|-0.13|0.3588
72524313|NCT02000622|144578533|SUPERIORITY||Hazard Ratio (HR)|0.9||||0.5665|TWO_SIDED|95.0|0.63|1.29||OS tested using a multiple testing procedure with a recycling strategy. With 140 OS events, a priori threshold for statistical significance (2-sided) was 0.018.|Log Rank|Stratified by received prior chemotherapy for metastatic breast cancer (yes/no) and receptor status.|Hazard ratio \<1 favours olaparib.|||1.29|0.63|0.5665
72524314|NCT02000622|144578535|SUPERIORITY||Mean Difference (Final Values)|7.5||||0.0035|TWO_SIDED|95.0|2.5|12.4|||Mixed Models Analysis|Variables for treatment, visit, treatment-visit interaction, adjusted for baseline global health status/QoL score, baseline score-visit interaction.|Mean difference \>0 favours olaparib.|||12.4|2.5|0.0035
72406478|NCT02942017|144321622|SUPERIORITY||LS Mean Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.109||0.5807|TWO_SIDED|95.0|-0.28|0.16|||MMRM|||Somatic Symptoms Gastrointestinal, Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.16|-0.28|0.5807
72406479|NCT02942017|144321622|SUPERIORITY||LS Mean Difference|0.09|STANDARD_ERROR_OF_MEAN|0.112||0.4241|TWO_SIDED|95.0|-0.13|0.31|||MMRM|||Somatic Symptoms Gastrointestinal, Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.31|-0.13|0.4241
72406480|NCT02942017|144321622|SUPERIORITY||LS Mean Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.115||0.7984|TWO_SIDED|95.0|-0.26|0.2|||MMRM|||Somatic Symptoms Gastrointestinal, Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.20|-0.26|0.7984
72406481|NCT02942017|144321622|SUPERIORITY||LS Mean Difference|0.02|STANDARD_ERROR_OF_MEAN|0.122||0.8732|TWO_SIDED|95.0|-0.22|0.26|||MMRM|||Somatic Symptoms Gastrointestinal, Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.26|-0.22|0.8732
72406482|NCT02942017|144321622|SUPERIORITY||LS Mean Difference|0.02|STANDARD_ERROR_OF_MEAN|0.107||0.8621|TWO_SIDED|95.0|-0.19|0.23|||MMRM|||Somatic Symptoms Gastrointestinal, Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.23|-0.19|0.8621
72406483|NCT02942017|144321622|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.126||0.1087|TWO_SIDED|95.0|-0.45|0.05|||MMRM|||Somatic Symptoms Gastrointestinal, Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.05|-0.45|0.1087
72524315|NCT02000622|144578536|SUPERIORITY||Hazard Ratio (HR)|0.57||||0.0005|TWO_SIDED|95.0|0.41|0.78|||Log Rank|Stratified by received prior chemotherapy for metastatic breast cancer (yes/no) and receptor status.|Hazard ratio \<1 favours olaparib.|||0.78|0.41|0.0005
72524316|NCT02000622|144578537|SUPERIORITY||Hazard Ratio (HR)|0.34|||<|0.0001|TWO_SIDED|95.0|0.24|0.47|||Log Rank|Stratified by received prior chemotherapy for metastatic breast cancer (yes/no) and receptor status.|Hazard ratio \<1 favours olaparib.|Supportive analysis to PFS.||0.47|0.24|<0.0001
72524317|NCT02000622|144578538|SUPERIORITY||Hazard Ratio (HR)|0.53||||0.0002|TWO_SIDED|95.0|0.38|0.74|||Log Rank|Stratified by received prior chemotherapy for metastatic breast cancer (yes/no) and receptor status.|Hazard ratio \<1 favours olaparib.|Supportive analysis to PFS2.||0.74|0.38|0.0002
72524318|NCT02000622|144578539|SUPERIORITY||Hazard Ratio (HR)|0.9||||0.5131|TWO_SIDED|95.0|0.66|1.23||OS tested using a multiple testing procedure with a recycling strategy. With 192 OS events, a priori threshold for statistical significance was 0.045.|Log Rank|Stratified by received prior chemotherapy for metastatic breast cancer (yes/no) and receptor status.|Hazard ratio \<1 favours olaparib.|||1.23|0.66|0.5131
72524319|NCT02000622|144578540|SUPERIORITY||Hazard Ratio (HR)|0.89||||0.4167|TWO_SIDED|95.0|0.67|1.18|||Log Rank|Stratified by received prior chemotherapy for metastatic breast cancer (yes/no) and receptor status.|Hazard ratio \<1 favours olaparib.|||1.18|0.67|0.4167
72406484|NCT02942017|144321622|SUPERIORITY||LS Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.125||0.2153|TWO_SIDED|95.0|-0.41|0.09|||MMRM|||Somatic Symptoms Gastrointestinal, Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.09|-0.41|0.2153
72406485|NCT02942017|144321622|SUPERIORITY||LS Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.145||0.1422|TWO_SIDED|95.0|-0.51|0.07|||MMRM|||Somatic Symptoms Gastrointestinal, Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.07|-0.51|0.1422
72524320|NCT02000622|144578541|SUPERIORITY||Hazard Ratio (HR)|0.36|||<|0.0001|TWO_SIDED|95.0|0.27|0.5|||Log Rank|Stratified by received prior chemotherapy for metastatic breast cancer (yes/no) and receptor status.|Hazard ratio \<1 favours olaparib.|Supportive analysis to PFS.||0.50|0.27|<0.0001
72524321|NCT02000622|144578542|SUPERIORITY||Hazard Ratio (HR)|0.54|||<|0.0001|TWO_SIDED|95.0|0.4|0.72|||Log Rank|Stratified by received prior chemotherapy for metastatic breast cancer (yes/no) and receptor status.|Hazard ratio \<1 favours olaparib.|Supportive analysis to PFS2.||0.72|0.40|<0.0001
72524322|NCT01405027|144578544|SUPERIORITY_OR_OTHER|||||||0.4864|TWO_SIDED||||||ANOVA|||||||0.4864
72524323|NCT05085327|144578549|OTHER|The t value from the '2-sided' Student-t distribution table corresponding to the upper 5% point with n-1 degrees of freedom was obtained and the labeled SPF value was determined as the largest whole number less than the following calculation: Labeled SPF = Mean SPF - (t\*SE).|CLM Original: Labeled SPF|13.0|||||TWO_SIDED|||||||||||||
72524324|NCT05085327|144578549|OTHER|The t value from the '2-sided' Student-t distribution table corresponding to the upper 5% point with n-1 degrees of freedom was obtained and the labeled SPF value was determined as the largest whole number less than the following calculation: Labeled SPF = Mean SPF - (t\*SE).|CLM Mint: Labeled SPF|13.0|||||TWO_SIDED|||||||||||||
72524325|NCT05085327|144578549|OTHER|The t value from the '2-sided' Student-t distribution table corresponding to the upper 5% point with n-1 degrees of freedom was obtained and the labeled SPF value was determined as the largest whole number less than the following calculation: Labeled SPF = Mean SPF - (t\*SE).|CLM Black Cherry: Labeled SPF|13.0|||||TWO_SIDED|||||||||||||
72524326|NCT03728881|144578573|NON_INFERIORITY|Let R=GMC1/GMC3 be the ratio of geometric mean concentrations of 1 dose to 3 doses. We reject the noninferiority hypothesis if at 36 months the lower limit of the two-sided 96% confidence interval on R ≥ 0.67 for HPV16. The overall Type 1 error rate for rejecting the null hypotheses for both HPV16 and HPV18 (i.e., declaring noninferiority of the 1D2V) at either time point was controlled at 0.025.|GMC Ratio|0.5|||||TWO_SIDED|96.0|0.44|0.57|||||Generalized estimating equations were used to estimate R and construct confidence intervals.|This procedure controls the overall type one error at 0.05. We are conducting 4 one-sided tests and will spend alpha as follows: 0.005 of the alpha each for HPV16 and for HPV18 at 24 months and 0.02 of the alpha each for HPV16 and for HPV18 at 36 months. The experiment-wise significance level accounting for multiple comparisons is ≤ 0.05 because the null chance of rejection for either HPV16 or HPV18 is ≤0.01 at 24 months by the Bonferroni inequality and ≤0.04 at 36 months.||0.57|0.44|
72524327|NCT03728881|144578575|NON_INFERIORITY|Let R=GMC1/GMC3 be the ratio of geometric mean concentrations of 1 dose to 3 doses. We reject the noninferiority hypothesis if at 36 months the lower limit of the two-sided 96% confidence interval on R ≥ 0.67 for HPV18. The overall Type 1 error rate for rejecting the null hypotheses for both HPV16 and HPV18 (i.e., declaring noninferiority of the 1D2V) at either time point was controlled at 0.025.|Ratio of the GMCs|1.11|||||TWO_SIDED|96.0|0.95|1.29|||||Generalized estimating equations were used to estimate R and construct confidence intervals.|This procedure controls the overall type one error at 0.05. We are conducting 4 one-sided tests and will spend alpha as follows: 0.005 of the alpha each for HPV16 and for HPV18 at 24 months and 0.02 of the alpha each for HPV16 and for HPV18 at 36 months. The experiment-wise significance level accounting for multiple comparisons is ≤ 0.05 because the null chance of rejection for either HPV16 or HPV18 is ≤0.01 at 24 months by the Bonferroni inequality and ≤0.04 at 36 months.||1.29|0.95|
72524328|NCT03728881|144578577|NON_INFERIORITY|Let R=GMC1/GMC3 be the ratio of geometric mean concentrations of 1 dose to 3 doses. We reject the noninferiority hypothesis if at 24 months the lower limit of the two-sided 99% confidence interval on R ≥ 0.67 for HPV16. The overall Type 1 error rate for rejecting the null hypotheses for both HPV16 and HPV18 (i.e., declaring noninferiority of the 1D2V) at either time point was controlled at 0.025.|GMC Ratio|0.42|||||TWO_SIDED|99.0|0.36|0.5|||||Generalized estimating equations were used to estimate R and construct confidence intervals.|This procedure controls the overall type one error at 0.05. We are conducting 4 one-sided tests and will spend alpha as follows: 0.005 of the alpha each for HPV16 and for HPV18 at 24 months and 0.02 of the alpha each for HPV16 and for HPV18 at 36 months. The experiment-wise significance level accounting for multiple comparisons is ≤0.05 because the null chance of rejection for either HPV16 or HPV18 is ≤0.01 at 24 months by the Bonferroni inequality and ≤0.04 at 36 months.||0.50|0.36|
72570941|NCT00546572|144670399|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 2-sided 95 % confidence interval for the geometric mean ratio (GMR) was \> 0.5 (2-fold criterion). Statistical significance demonstrated if the lower limit of the 2-sided 95 % confidence interval for the geometric mean ratio (GMR) was \> 1.|ratio of geometric mean titer|2.0|||||TWO_SIDED|95.0|1.55|2.63|||||Confidence intervals for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS).|Serotype 5: ratio of GMT (13vPnC to 23vPS) calculated by back transforming the mean difference between vaccine groups on the logarithmic scale.||2.63|1.55|
72542562|NCT02496221|144614953|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01456||||0.0733|TWO_SIDED|95.0|-0.030666|0.001554|||Mixed Models Analysis|Treatment (albiglutide or placebo), and period as fixed effects and participant as random effect||||0.001554|-0.030666|0.0733
72524329|NCT03728881|144578579|NON_INFERIORITY|Let R=GMC1/GMC3 be the ratio of geometric mean concentrations of 1 dose to 3 doses. We reject the noninferiority hypothesis if at 24 months the lower limit of the two-sided 99% confidence interval on R ≥ 0.67 for HPV18. The overall Type 1 error rate for rejecting the null hypotheses for both HPV16 and HPV18 (i.e., declaring noninferiority of the 1D2V) at either time point was controlled at 0.025.|GMC Ratio|0.9|||||TWO_SIDED|99.0|0.75|1.08|||||Generalized estimating equations were used to estimate R and construct confidence intervals.|This procedure controls the overall type one error at 0.05. We are conducting 4 one sided tests and will spend alpha as follows: 0.005 of the alpha each for HPV16 and for HPV18 at 24 months and 0.02 of the alpha each for HPV16 and for HPV18 at 36 months. The experiment-wise significance level accounting for multiple comparisons is ≤0.05 because the null chance of rejection for either HPV16 or HPV18 is ≤0.01 at 24 months by the Bonferroni inequality and ≤0.04 at 36 months.||1.08|0.75|
72524330|NCT03728881|144578580|EQUIVALENCE|We will use a Fisher Exact test to test for the difference of the seroconversion rate between one-dose and three-dose recipients. A p-value under 0.05 will be regarded as significant.|||||=|1|||||||Fisher Exact|||||||=1.0
72524331|NCT03728881|144578581|EQUIVALENCE|We will use a Fisher Exact test to test for the difference of the seroconversion rate between one-dose and three-dose recipients. A p-value under 0.05 will be regarded as significant.|||||=|0.006|||||||Fisher Exact|||||||=0.006
72524332|NCT03728881|144578582|EQUIVALENCE|We will use a Fisher Exact test to test for the difference of the seroconversion rate between one-dose and three-dose recipients. A p-value under 0.05 will be regarded as significant.|||||=|1|||||||Fisher Exact|||||||=1.0
72524333|NCT03728881|144578583|EQUIVALENCE|We will use a Fisher Exact test to test for the difference of the seroconversion rate between one-dose and three-dose recipients. A p-value under 0.05 will be regarded as significant.|||||=|0.48|||||||Fisher Exact|||||||=0.48
72524334|NCT03728881|144578589|NON_INFERIORITY|Let R=GMC1/GMC3 be the ratio of geometric mean concentrations of 1 dose to 3 doses. We reject the noninferiority hypothesis if at 36 months the lower limit of the two-sided 96% confidence interval on R ≥ 0.67 for HPV16 and HPV18. The overall Type 1 error rate for rejecting the null hypotheses for both HPV16 and HPV18 (i.e., declaring noninferiority of the 1D2V) at either time point was controlled at 0.025.)|GMC Ratio|0.49|||||TWO_SIDED|96.0|0.42|0.56|||||Generalized estimating equations were used to estimate R and construct confidence intervals.|||0.56|0.42|
72524335|NCT03728881|144578590|EQUIVALENCE|We will use a Fisher Exact test to test for the difference of the seroconversion rate between one-dose and three-dose recipients. A p-value under 0.05 will be regarded as significant.||||||1|||||||Fisher Exact|||||||1.0
72524336|NCT03728881|144578592|NON_INFERIORITY|Let R=GMC1/GMC3 be the ratio of geometric mean concentrations of 1 dose to 3 doses. We reject the noninferiority hypothesis if at 36 months the lower limit of the two-sided 96% confidence interval on R ≥ 0.67 for HPV16 and HPV18. The overall Type 1 error rate for rejecting the null hypotheses for both HPV16 and HPV18 (i.e., declaring noninferiority of the 1D2V) at either time point was controlled at 0.025.)|GMC Ratio|1.09|||||TWO_SIDED|96.0|0.93|1.27||||||||1.27|0.93|
72524337|NCT03728881|144578593|EQUIVALENCE|We will use a Fisher Exact test to test for the difference of the seroconversion rate between one-dose and three-dose recipients. A p-value under 0.05 will be regarded as significant.|||||=|0.0006|||||||Fisher Exact|||||||=0.0006
72524338|NCT03728881|144578595|NON_INFERIORITY|Let R=GMC1/GMC3 be the ratio of geometric mean concentrations of 1 dose to 3 doses. We reject the noninferiority hypothesis if at 24 months the lower limit of the two-sided 99% confidence interval on R ≥ 0.67 for HPV16 and HPV18. The overall Type 1 error rate for rejecting the null hypotheses for both HPV16 and HPV18 (i.e., declaring noninferiority of the 1D2V) at either time point was controlled at 0.025.|GMC Ratio|0.41|||||TWO_SIDED|99.0|0.35|0.49|||||Generalized estimating equations were used to estimate R and construct confidence intervals.|||0.49|0.35|
72524339|NCT03728881|144578596|EQUIVALENCE|We will use a Fisher Exact test to test for the difference of the seroconversion rate between one-dose and three-dose recipients. A p-value under 0.05 will be regarded as significant.|||||=|1|||||||Fisher Exact|||||||=1.0
72570942|NCT00546572|144670399|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 2-sided 95 % confidence interval for the geometric mean ratio (GMR) was \> 0.5 (2-fold criterion). Statistical significance demonstrated if the lower limit of the 2-sided 95 % confidence interval for the geometric mean ratio (GMR) was \> 1.|ratio of geometric mean titer|3.0|||||TWO_SIDED|95.0|2.21|4.13|||||Confidence intervals for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS).|Serotype 6B: ratio of GMT (13vPnC to 23vPS) calculated by back transforming the mean difference between vaccine groups on the logarithmic scale.||4.13|2.21|
72524340|NCT03728881|144578598|NON_INFERIORITY|Let R=GMC1/GMC3 be the ratio of geometric mean concentrations of 1 dose to 3 doses. We reject the noninferiority hypothesis if at 24 months the lower limit of the two-sided 99% confidence interval on R ≥ 0.67 for HPV16 and HPV18. The overall Type 1 error rate for rejecting the null hypotheses for both HPV16 and HPV18 (i.e., declaring noninferiority of the 1D2V) at either time point was controlled at 0.025.|GMC Ratio|0.86|||||TWO_SIDED|99.0|0.71|1.04|||||Generalized estimating equations were used to estimate R and construct confidence intervals.|||1.04|0.71|
72524341|NCT03728881|144578599|EQUIVALENCE|We will use a Fisher Exact test to test for the difference of the seroconversion rate between one-dose and three-dose recipients. A p-value under 0.05 will be regarded as significant.|||||=|0.478|||||||Fisher Exact|||||||=0.478
72524342|NCT03728881|144578601|NON_INFERIORITY|We reject the noninferiority hypothesis if the lower limit of the two-sided 95% confidence interval on R ≥ 0.67 for HPV16 and HPV18.|GMC Ratio|1.33|||||TWO_SIDED|95.0|1.12|1.58|||||Generalized estimating equations were used to estimate R and construct confidence intervals.|||1.58|1.12|
72570943|NCT00546572|144670399|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 2-sided 95 % confidence interval for the geometric mean ratio (GMR) was \> 0.5 (2-fold criterion). Statistical significance demonstrated if the lower limit of the 2-sided 95 % confidence interval for the geometric mean ratio (GMR) was \> 1.|ratio of geometric mean titer|1.5|||||TWO_SIDED|95.0|1.07|2.18|||||Confidence intervals for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS).|Serotype 7F: ratio of GMT (13vPnC to 23vPS) calculated by back transforming the mean difference between vaccine groups on the logarithmic scale.||2.18|1.07|
72406486|NCT02942017|144321622|SUPERIORITY||LS Mean Difference|0.04|STANDARD_ERROR_OF_MEAN|0.114||0.7211|TWO_SIDED|95.0|-0.19|0.27|||MMRM|||Somatic Symptoms Gastrointestinal, Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.27|-0.19|0.7211
72406487|NCT02942017|144321622|SUPERIORITY||LS Mean Difference|0.02|STANDARD_ERROR_OF_MEAN|0.103||0.8224|TWO_SIDED|95.0|-0.18|0.23|||MMRM|||Somatic Symptoms General, Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.23|-0.18|0.8224
72625189|NCT01098747|144780078|SUPERIORITY_OR_OTHER||LS mean difference|-0.33||||0.055|TWO_SIDED|95.0|-0.67|0.01||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||6 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS mean from the ANOVA model.||0.01|-0.67|0.055
72625190|NCT01098747|144780078|SUPERIORITY_OR_OTHER||LS mean difference|1.39|||<|0.001|TWO_SIDED|95.0|0.91|1.88||p-value was calculated using ANOVA model with treatment, baseline PSR and gender PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||7 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS mean from the ANOVA model.||1.88|0.91|<0.001
72406488|NCT02942017|144321622|SUPERIORITY||LS Mean Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.126||0.6362|TWO_SIDED|95.0|-0.31|0.19|||MMRM|||Somatic Symptoms General, Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.19|-0.31|0.6362
72406489|NCT02942017|144321622|SUPERIORITY||LS Mean Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.123||0.6094|TWO_SIDED|95.0|-0.31|0.18|||MMRM|||Somatic Symptoms General, Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.18|-0.31|0.6094
72406490|NCT02942017|144321622|SUPERIORITY||LS Mean Difference|-0.25|STANDARD_ERROR_OF_MEAN|0.123||0.0457|TWO_SIDED|95.0|-0.49|0.0|||MMRM|||Somatic Symptoms General, Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.00|-0.49|0.0457
72524343|NCT03728881|144578604|NON_INFERIORITY|We reject the noninferiority hypothesis if the lower limit of the two-sided 95% confidence interval on R ≥ 0.67 for HPV16 and HPV18.|GMC Ratio|1.29|||||TWO_SIDED|95.0|1.09|1.54|||||Generalized estimating equations were used to estimate R and construct confidence intervals.|||1.54|1.09|
72524344|NCT03728881|144578607|NON_INFERIORITY|We reject the noninferiority hypothesis if the lower limit of the two-sided 95% confidence interval on R ≥ 0.67 for HPV16 and HPV18.|GMC Ratio|1.48|||||TWO_SIDED|95.0|1.2|1.81|||||Generalized estimating equations were used to estimate R and construct confidence intervals.|||1.81|1.20|
72524345|NCT03728881|144578608|EQUIVALENCE|We will use a Fisher Exact test to test for the difference of the seroconversion rate between one-dose 9-10 year old girls and one-dose 11-14 year old girls. A p-value under 0.05 will be regarded as significant.|||||=|1|||||||Fisher Exact|||||||=1.0
72524346|NCT03728881|144578610|NON_INFERIORITY|We reject the noninferiority hypothesis if the lower limit of the two-sided 95% confidence interval on R ≥ 0.67 for HPV16 and HPV18.|GMC Ratio|1.42|||||TWO_SIDED|95.0|1.15|1.75|||||Generalized estimating equations were used to estimate R and construct confidence intervals.|||1.75|1.15|
72524347|NCT03728881|144578611|EQUIVALENCE|We will use a Fisher Exact test to test for the difference of the seroconversion rate between one-dose 9-10 year old girls and one-dose 11-14 year old girls. A p-value under 0.05 will be regarded as significant.|||||=|0.368|||||||Fisher Exact|||||||=0.368
72524348|NCT03728881|144578613|NON_INFERIORITY|Let R=GMC1/GMC3 be the ratio of geometric mean concentrations of 1 dose to 3 doses. We reject the noninferiority hypothesis if at 36 months the lower limit of the two-sided 96% confidence interval on R ≥ 0.67 for HPV16 and HPV18. The overall Type 1 error rate for rejecting the null hypotheses for both HPV16 and HPV18 (i.e., declaring noninferiority of the 1D2V) at either time point was controlled at 0.025.)|GMC Ratio|0.46|||||TWO_SIDED|96.0|0.38|0.56|||||Generalized estimating equations were used to estimate R and construct confidence intervals.|This procedure controls the overall type one error at 0.05. We are conducting 4 one-sided tests and will spend alpha as follows: 0.005 of the alpha each for HPV16 and for HPV18 at 24 months and 0.02 of the alpha each for HPV16 and for HPV18 at 36 months. The experiment-wise significance level accounting for multiple comparisons is ≤0.05 because the null chance of rejection for either HPV16or HPV18 is ≤0.01 at 24 months by the Bonferroni inequality and ≤0.04 at 36 months.||0.56|0.38|
72524349|NCT03728881|144578613|NON_INFERIORITY|Let R=GMC1/GMC3 be the ratio of geometric mean concentrations of 1 dose to 3 doses. We reject the noninferiority hypothesis if at 36 months the lower limit of the two-sided 96% confidence interval on R ≥ 0.67 for HPV16 and HPV18. The overall Type 1 error rate for rejecting the null hypotheses for both HPV16 and HPV18 (i.e., declaring noninferiority of the 1D2V) at either time point was controlled at 0.025.)|GMC Ratio|0.58|||||TWO_SIDED|96.0|0.48|0.7|||||Generalized estimating equations were used to estimate R and construct confidence intervals.|||0.70|0.48|
72524350|NCT03728881|144578613|EQUIVALENCE|A p-value \<0.05 is interpreted as significantly different GMC ratios in different strata.|||||=|0.079||||||The p-values test for heterogeneity in the GMC ratios estimated from the stratified analyses.|p-values test for heterogeneity|||||||=0.079
72406491|NCT02942017|144321622|SUPERIORITY||LS Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.14||0.5691|TWO_SIDED|95.0|-0.36|0.2|||MMRM|||Somatic Symptoms General, Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.20|-0.36|0.5691
72406492|NCT02942017|144321622|SUPERIORITY||LS Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.13||0.2942|TWO_SIDED|95.0|-0.4|0.12|||MMRM|||Somatic Symptoms General, Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.12|-0.40|0.2942
72406493|NCT02942017|144321622|SUPERIORITY||LS Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.136||0.5389|TWO_SIDED|95.0|-0.35|0.19|||MMRM|||Somatic Symptoms General, Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.19|-0.35|0.5389
72406494|NCT02942017|144321622|SUPERIORITY||LS Mean Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.141||0.4061|TWO_SIDED|95.0|-0.4|0.16|||MMRM|||Somatic Symptoms General, Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.16|-0.40|0.4061
72524351|NCT03728881|144578614|EQUIVALENCE|We will use a Fisher Exact test to test for the difference of the seroconversion rate between the older one-dose recipients and the older three-dose recipients. A p-value under 0.05 will be regarded as significant.|||||=|1|||||||Fisher Exact|||NOTE: Younger one-dose recipients (9-11 Year Old Girls) and three-dose recipients (18-21 Year Old Women) both had a 100% seroconversion proportion for HPV16 at 36 months, so a p-value for the difference of the seroconversion rate between them could not be calculated. Therefore, we only include the calculated p-value for the comparison of the seroconversion rate between older one-dose recipients (9-11 Year Old Girls) and three-dose recipients (22-25 Year Old Women).||||=1.0000
72524352|NCT03728881|144578616|NON_INFERIORITY|Let R=GMC1/GMC3 be the ratio of geometric mean concentrations of 1 dose to 3 doses. We reject the noninferiority hypothesis if at 36 months the lower limit of the two-sided 96% confidence interval on R ≥ 0.67 for HPV16 and HPV18. The overall Type 1 error rate for rejecting the null hypotheses for both HPV16 and HPV18 (i.e., declaring noninferiority of the 1D2V) at either time point was controlled at 0.025.)|GMC Ratio|1.01|||||TWO_SIDED|96.0|0.82|1.25||||||This procedure controls the overall type one error at 0.05. We are conducting 4 one-sided tests and will spend alpha as follows: 0.005 of the alpha each for HPV16 and for HPV18 at 24 months and 0.02 of the alpha each for HPV16 and for HPV18 at 36 months. The experiment-wise significance level accounting for multiple comparisons is ≤0.05 because the null chance of rejection for either HPV16or HPV18 is ≤0.01 at 24 months by the Bonferroni inequality and ≤0.04 at 36 months.||1.25|0.82|
72524353|NCT03728881|144578616|NON_INFERIORITY|Let R=GMC1/GMC3 be the ratio of geometric mean concentrations of 1 dose to 3 doses. We reject the noninferiority hypothesis if at 36 months the lower limit of the two-sided 96% confidence interval on R ≥ 0.67 for HPV16 and HPV18. The overall Type 1 error rate for rejecting the null hypotheses for both HPV16 and HPV18 (i.e., declaring noninferiority of the 1D2V) at either time point was controlled at 0.025.)|GMC Ratio|1.24|||||TWO_SIDED|96.0|1.01|1.54||||||The cohort for the analysis of HPV16 at 36 months by enrollment age group includes participants who received the appropriate number of vaccine doses within the specified windows, were initially seronegative for HPV16, underwent blood collection at the 36-month mark, and reported no additional HPV vaccinations outside the study before the 36-month blood collection, as confirmed by self-report or serologic testing for HPV6/HPV11.||1.54|1.01|
72524354|NCT03728881|144578616|EQUIVALENCE|A p-value \<0.05 is interpreted as significantly different GMC ratios in different strata.|||||=|0.14||||||The p-values test for heterogeneity in the GMC ratios estimated from the stratified analyses.|p-values test for heterogeneity|||||||=0.14
72524355|NCT03728881|144578617|EQUIVALENCE|We will use a Fisher Exact test to test for the difference of the seroconversion rate between the younger one-dose recipients and the younger three-dose recipients.|||||=|0.001||||||A p-value under 0.05 will be regarded as significant.|Fisher Exact|||Calculated p-value for the comparison of the seroconversion rate for HPV18 at 36 months between younger one-dose recipients (9-11 Year Old Girls) and the younger three-dose recipients (18-21 Year Old Women).||||=0.001
72524356|NCT03728881|144578617|EQUIVALENCE|We will use a Fisher Exact test to test for the difference of the seroconversion rate between older one-dose and older three-dose recipients. A p-value under 0.05 will be regarded as significant.|||||=|0.737||||||A p-value under 0.05 will be regarded as significant.|Fisher Exact|||Calculated p-value for the comparison of the seroconversion rate for HPV18 at 36 months between older one-dose recipients (12-14 Year Old Girls) and the older three-dose recipients (22-25 Year Old Women).||||=0.737
72570944|NCT00546572|144670399|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 2-sided 95 % confidence interval for the geometric mean ratio (GMR) was \> 0.5 (2-fold criterion).|ratio of geometric mean titer|2.0|||||TWO_SIDED|95.0|1.36|2.97|||||Confidence intervals for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS).|Serotype 9V: ratio of GMT (13vPnC to 23vPS) calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. Statistical significance demonstrated if the lower limit of the 2-sided 95 % confidence interval for the geometric mean ratio (GMR) was \> 1.||2.97|1.36|
72625191|NCT01098747|144780078|SUPERIORITY_OR_OTHER||LS mean difference|-0.37||||0.04|TWO_SIDED|95.0|-0.71|-0.02||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||7 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS mean from the ANOVA model.||-0.02|-0.71|0.040
72625192|NCT01098747|144780078|SUPERIORITY_OR_OTHER||LS mean difference|1.2|||<|0.001|TWO_SIDED|95.0|0.71|1.69||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||8 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS mean from the ANOVA model.||1.69|0.71|<0.001
72406495|NCT02942017|144321622|SUPERIORITY||LS Mean Difference|-0.25|STANDARD_ERROR_OF_MEAN|0.153||0.099|TWO_SIDED|95.0|-0.56|0.05|||MMRM|||Somatic Symptoms General, Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.05|-0.56|0.0990
72524357|NCT03728881|144578619|NON_INFERIORITY|Let R=GMC1/GMC3 be the ratio of geometric mean concentrations of 1 dose to 3 doses. We reject the noninferiority hypothesis if at 24 months the lower limit of the two-sided 99% confidence interval on R ≥ 0.67 for HPV16 and HPV18. The overall Type 1 error rate for rejecting the null hypotheses for both HPV16 and HPV18 (i.e., declaring noninferiority of the 1D2V) at either time point was controlled at 0.025.|GMC Ratio|0.41|||||TWO_SIDED|99.0|0.33|0.52||||||This procedure controls the overall type one error at 0.05. We are conducting 4 one-sided tests and will spend alpha as follows: 0.005 of the alpha each for HPV16 and for HPV18 at 24 months and 0.02 of the alpha each for HPV16 and for HPV18 at 36 months. The experiment-wise significance level accounting for multiple comparisons is ≤0.05 because the null chance of rejection for either HPV16or HPV18 is ≤0.01 at 24 months by the Bonferroni inequality and ≤0.04 at 36 months.||0.52|0.33|
72524358|NCT03728881|144578619|NON_INFERIORITY|Let R=GMC1/GMC3 be the ratio of geometric mean concentrations of 1 dose to 3 doses. We reject the noninferiority hypothesis if at 24 months the lower limit of the two-sided 99% confidence interval on R ≥ 0.67 for HPV16 and HPV18. The overall Type 1 error rate for rejecting the null hypotheses for both HPV16 and HPV18 (i.e., declaring noninferiority of the 1D2V) at either time point was controlled at 0.025.|GMC Ratio|0.47|||||TWO_SIDED|99.0|0.37|0.6||||||This procedure controls the overall type one error at 0.05. We are conducting 4 one-sided tests and will spend alpha as follows: 0.005 of the alpha each for HPV16 and for HPV18 at 24 months and 0.02 of the alpha each for HPV16 and for HPV18 at 36 months. The experiment-wise significance level accounting for multiple comparisons is ≤0.05 because the null chance of rejection for either HPV16or HPV18 is ≤0.01 at 24 months by the Bonferroni inequality and ≤0.04 at 36 months.||0.60|0.37|
72524359|NCT03728881|144578619|EQUIVALENCE|The p-values test for heterogeneity in the GMC ratios estimated from the stratified analyses.|||||=|0.028||||||A p-value \<0.05 is interpreted as significantly different GMC ratios in different strata.|p-values test for heterogeneity|||||||=0.028
72524360|NCT03728881|144578620|EQUIVALENCE|We will use a Fisher Exact test to test for the difference of the seroconversion rate between the older one-dose recipients and the older three-dose recipients.|||||=|1||||||A p-value under 0.05 will be regarded as significant.|Fisher Exact|||NOTE: Younger one-dose recipients (9-11 Year Old Girls) and three-dose recipients (18-21 Year Old Women) both had a 100% seroconversion proportion for HPV16 at 24months, so a p-value for the difference of the seroconversion rate between them could not be calculated. Therefore, we only include the calculated p-value for the comparison of the seroconversion rate between older one-dose recipients (9-11 Year Old Girls) and three-dose recipients (22-25 Year Old Women).||||=1.000
72524361|NCT03728881|144578622|NON_INFERIORITY|Let R=GMC1/GMC3 be the ratio of geometric mean concentrations of 1 dose to 3 doses. We reject the noninferiority hypothesis if at 24 months the lower limit of the two-sided 99% confidence interval on R ≥ 0.67 for HPV16 and HPV18. The overall Type 1 error rate for rejecting the null hypotheses for both HPV16 and HPV18 (i.e., declaring noninferiority of the 1D2V) at either time point was controlled at 0.025.|GMC Ratio|0.85|||||TWO_SIDED|99.0|0.65|1.1||||||This procedure controls the overall type one error at 0.05. We are conducting 4 one-sided tests and will spend alpha as follows: 0.005 of the alpha each for HPV16 and for HPV18 at 24 months and 0.02 of the alpha each for HPV16 and for HPV18 at 36 months. The experiment-wise significance level accounting for multiple comparisons is ≤0.05 because the null chance of rejection for either HPV16or HPV18 is ≤0.01 at 24 months by the Bonferroni inequality and ≤0.04 at 36 months.||1.10|0.65|
72524362|NCT03728881|144578622|NON_INFERIORITY|Let R=GMC1/GMC3 be the ratio of geometric mean concentrations of 1 dose to 3 doses. We reject the noninferiority hypothesis if at 24 months the lower limit of the two-sided 99% confidence interval on R ≥ 0.67 for HPV16 and HPV18. The overall Type 1 error rate for rejecting the null hypotheses for both HPV16 and HPV18 (i.e., declaring noninferiority of the 1D2V) at either time point was controlled at 0.025.|GMC Ratio|1.0|||||TWO_SIDED|99.0|0.77|1.29||||||This procedure controls the overall type one error at 0.05. We are conducting 4 one-sided tests and will spend alpha as follows: 0.005 of the alpha each for HPV16 and for HPV18 at 24 months and 0.02 of the alpha each for HPV16 and for HPV18 at 36 months. The experiment-wise significance level accounting for multiple comparisons is ≤0.05 because the null chance of rejection for either HPV16or HPV18 is ≤0.01 at 24 months by the Bonferroni inequality and ≤0.04 at 36 months.||1.29|0.77|
72524363|NCT03728881|144578622|EQUIVALENCE|The p-values test for heterogeneity in the GMC ratios estimated from the stratified analyses.|||||=|0.24||||||A p-value \<0.05 is interpreted as significantly different GMC ratios in different strata.|The p-values test for heterogeneity|||||||=0.24
72524364|NCT03728881|144578623|EQUIVALENCE|We will use a Fisher Exact test to test for the difference of the seroconversion rate between younger one-dose and younger three-dose recipients.|||||=|0.216||||||A p-value under 0.05 will be regarded as significant.|Fisher Exact|||The calculated p-value for the comparison of the seroconversion rate of HPV18 at 24 months between younger one-dose recipients (9-12 Year Old Girls) and younger three-dose recipients (18-21 Year Old Women).||||=0.216
72524365|NCT03728881|144578623|EQUIVALENCE|We will use a Fisher Exact test to test for the difference of the seroconversion rate between older one-dose and older three-dose recipients.|||||=|1||||||A p-value under 0.05 will be regarded as significant.|Fisher Exact|||The calculated p-value for the comparison of the seroconversion rate of HPV18 at 24 months between older one-dose recipients (12-14 Year Old Girls) and older three-dose recipients (22-25 Year Old Women).||||=1.000
72625193|NCT01098747|144780078|SUPERIORITY_OR_OTHER||LS mean difference|-0.44||||0.015|TWO_SIDED|95.0|-0.79|-0.08||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||8 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS mean from the ANOVA model.||-0.08|-0.79|0.015
72524366|NCT03728881|144578625|NON_INFERIORITY|Let R=GMC1/GMC3 be the ratio of geometric mean concentrations of 1 dose to 3 doses. We reject the noninferiority hypothesis if at 36 months the lower limit of the two-sided 96% confidence interval on R ≥ 0.67 for HPV16 and HPV18. The overall Type 1 error rate for rejecting the null hypotheses for both HPV16 and HPV18 (i.e., declaring noninferiority of the 1D2V) at either time point was controlled at 0.025.)|GMC Ratio|0.52|||||TWO_SIDED|96.0|0.43|0.64||||||This procedure controls the overall type one error at 0.05. We are conducting 4 one-sided tests and will spend alpha as follows: 0.005 of the alpha each for HPV16 and for HPV18 at 24 months and 0.02 of the alpha each for HPV16 and for HPV18 at 36 months. The experiment-wise significance level accounting for multiple comparisons is ≤ 0.05 because the null chance of rejection for either HPV16 or HPV18 is ≤0.01 at 24 months by the Bonferroni inequality and ≤0.04 at 36 months.||0.64|0.43|
72524367|NCT03728881|144578625|NON_INFERIORITY|Let R=GMC1/GMC3 be the ratio of geometric mean concentrations of 1 dose to 3 doses. We reject the noninferiority hypothesis if at 36 months the lower limit of the two-sided 96% confidence interval on R ≥ 0.67 for HPV16 and HPV18. The overall Type 1 error rate for rejecting the null hypotheses for both HPV16 and HPV18 (i.e., declaring noninferiority of the 1D2V) at either time point was controlled at 0.025.)|GMC Ratio|0.49|||||TWO_SIDED|96.0|0.41|0.58||||||This procedure controls the overall type one error at 0.05. We are conducting 4 one-sided tests and will spend alpha as follows: 0.005 of the alpha each for HPV16 and for HPV18 at 24 months and 0.02 of the alpha each for HPV16 and for HPV18 at 36 months. The experiment-wise significance level accounting for multiple comparisons is ≤ 0.05 because the null chance of rejection for either HPV16 or HPV18 is ≤0.01 at 24 months by the Bonferroni inequality and ≤0.04 at 36 months.||0.58|0.41|
72524368|NCT03728881|144578625|EQUIVALENCE|The p-values test for heterogeneity in the GMC ratios estimated from the stratified analyses.|||||=|0.73||||||A p-value \<0.05 is interpreted as significantly different GMC ratios in different strata.|The p-values test for heterogeneity|||||||=0.73
72524369|NCT03728881|144578626|EQUIVALENCE|We will use a Fisher Exact test to test for the difference of the seroconversion rate one-dose and three-dose recipients who enrolled June - August.|||||=|1||||||A p-value under 0.05 will be regarded as significant.|Fisher Exact|||NOTE: One-dose recipients and three-dose recipients enrolled April - May both had a 100% seroconversion proportion for HPV16 at 36 months, so the p-value for the difference of the seroconversion rate between them could not be calculated. Therefore, we only include the calculated p-value for the comparison of the seroconversion rate between one-dose recipients and three-dose recipients enrolled June - August.||||=1.000
72524370|NCT03728881|144578628|NON_INFERIORITY|Let R=GMC1/GMC3 be the ratio of geometric mean concentrations of 1 dose to 3 doses. We reject the noninferiority hypothesis if at 36 months the lower limit of the two-sided 96% confidence interval on R ≥ 0.67 for HPV16 and HPV18. The overall Type 1 error rate for rejecting the null hypotheses for both HPV16 and HPV18 (i.e., declaring noninferiority of the 1D2V) at either time point was controlled at 0.025.)|GMC Ratio|1.26||||||96.0|1.0|1.58||||||This procedure controls the overall type one error at 0.05. We are conducting 4 one-sided tests and will spend alpha as follows: 0.005 of the alpha each for HPV16 and for HPV18 at 24 months and 0.02 of the alpha each for HPV16 and for HPV18 at 36 months. The experiment-wise significance level accounting for multiple comparisons is ≤ 0.05 because the null chance of rejection for either HPV16 or HPV18 is ≤0.01 at 24 months by the Bonferroni inequality and ≤0.04 at 36 months.||1.58|1.00|
72524371|NCT03728881|144578628|NON_INFERIORITY|Let R=GMC1/GMC3 be the ratio of geometric mean concentrations of 1 dose to 3 doses. We reject the noninferiority hypothesis if at 36 months the lower limit of the two-sided 96% confidence interval on R ≥ 0.67 for HPV16 and HPV18. The overall Type 1 error rate for rejecting the null hypotheses for both HPV16 and HPV18 (i.e., declaring noninferiority of the 1D2V) at either time point was controlled at 0.025.)|GMC Ratio|1.01||||||96.0|0.83|1.24||||||||1.24|0.83|
72524372|NCT03728881|144578628|EQUIVALENCE|The p-values test for heterogeneity in the GMC ratios estimated from the stratified analyses.|||||=|0.15||||||A p-value \<0.05 is interpreted as significantly different GMC ratios in different strata.|The p-values test for heterogeneity|||||||=0.15
72524373|NCT03728881|144578629|EQUIVALENCE|We will use a Fisher Exact test to test for the difference of the seroconversion rate between one-dose and three-dose recipients enrolled April - May.|||||=|0.253||||||A p-value under 0.05 will be regarded as significant.|Fisher Exact|||The calculated p-value for the comparison of the seroconversion rate of HPV18 at 36 months between one-dose recipients and three-dose recipients enrolled April - May.||||=0.253
72570945|NCT00546572|144670399|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 2-sided 95 % confidence interval for the geometric mean ratio (GMR) was \> 0.5 (2-fold criterion). Statistical significance demonstrated if the lower limit of the 2-sided 95 % confidence interval for the geometric mean ratio (GMR) was \> 1.|ratio of geometric mean titer|1.0|||||TWO_SIDED|95.0|0.73|1.33|||||Confidence intervals for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS).|Serotype 14: ratio of GMT (13vPnC to 23vPS) calculated by back transforming the mean difference between vaccine groups on the logarithmic scale.||1.33|0.73|
72570946|NCT00546572|144670399|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 2-sided 95 % confidence interval for the geometric mean ratio (GMR) was \> 0.5 (2-fold criterion). Statistical significance demonstrated if the lower limit of the 2-sided 95 % confidence interval for the geometric mean ratio (GMR) was \> 1.|ratio of geometric mean titer|1.9|||||TWO_SIDED|95.0|1.42|2.5|||||Confidence intervals for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS).|Serotype 18C: ratio of GMT (13vPnC to 23vPS) calculated by back transforming the mean difference between vaccine groups on the logarithmic scale.||2.50|1.42|
72570947|NCT00546572|144670399|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 2-sided 95 % confidence interval for the geometric mean ratio (GMR) was \> 0.5 (2-fold criterion). Statistical significance demonstrated if the lower limit of the 2-sided 95 % confidence interval for the geometric mean ratio (GMR) was \> 1.|ratio of geometric mean titer|1.8|||||TWO_SIDED|95.0|1.43|2.2|||||Confidence intervals for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS).|Serotype 19A: ratio of GMT (13vPnC to 23vPS) calculated by back transforming the mean difference between vaccine groups on the logarithmic scale.||2.20|1.43|
72524374|NCT03728881|144578629|EQUIVALENCE|We will use a Fisher Exact test to test for the difference of the seroconversion rate between one-dose and three-dose recipients enrolled June - August.|||||=|0.015||||||A p-value under 0.05 will be regarded as significant|Fisher Exact|||The calculated p-value for the comparison of the seroconversion rate of HPV18 at 36 months between one-dose recipients and three-dose recipients enrolled June - August.||||=0.015
72524375|NCT03728881|144578631|NON_INFERIORITY|Let R=GMC1/GMC3 be the ratio of geometric mean concentrations of 1 dose to 3 doses. We reject the noninferiority hypothesis if at 24 months the lower limit of the two-sided 99% confidence interval on R ≥ 0.67 for HPV16 and HPV18. The overall Type 1 error rate for rejecting the null hypotheses for both HPV16 and HPV18 (i.e., declaring noninferiority of the 1D2V) at either time point was controlled at 0.025.|GMC Ratio|0.43||||||99.0|0.33|0.55||||||This procedure controls the overall type one error at 0.05. We are conducting 4 one-sided tests and will spend alpha as follows: 0.005 of the alpha each for HPV16 and for HPV18 at 24 months and 0.02 of the alpha each for HPV16 and for HPV18 at 36 months. The experiment-wise significance level accounting for multiple comparisons is ≤ 0.05 because the null chance of rejection for either HPV16 or HPV18 is ≤0.01 at 24 months by the Bonferroni inequality and ≤0.04 at 36 months.||0.55|0.33|
72524376|NCT03728881|144578631|NON_INFERIORITY|Let R=GMC1/GMC3 be the ratio of geometric mean concentrations of 1 dose to 3 doses. We reject the noninferiority hypothesis if at 24 months the lower limit of the two-sided 99% confidence interval on R ≥ 0.67 for HPV16 and HPV18. The overall Type 1 error rate for rejecting the null hypotheses for both HPV16 and HPV18 (i.e., declaring noninferiority of the 1D2V) at either time point was controlled at 0.025.|GMC Ratio|0.42|||||TWO_SIDED|99.0|0.34|0.52||||||||0.52|0.34|
72524377|NCT03728881|144578631|EQUIVALENCE|The p-values test for heterogeneity in the GMC ratios estimated from the stratified analyses.|||||=|0.95||||||A p-value \<0.05 is interpreted as significantly different GMC ratios in different strata.|p-values test for heterogeneity|||||||=0.95
72524378|NCT03728881|144578632|EQUIVALENCE|We will use a Fisher Exact test to test for the difference of the seroconversion rate between one-dose and three-dose recipients enrolled June - August.|||||=|1||||||A p-value under 0.05 will be regarded as significant.|Fisher Exact|||NOTE: One-dose recipients and three-dose recipients enrolled April - May both had a 100% seroconversion proportion for HPV16 at 24 months, so the p-value for the difference of the seroconversion rate between them could not be calculated. Therefore, we only include the calculated p-value for the comparison of the seroconversion rate between one-dose recipients and three-dose recipients enrolled June - August.||||=1.000
72524379|NCT03728881|144578634|NON_INFERIORITY|Let R=GMC1/GMC3 be the ratio of geometric mean concentrations of 1 dose to 3 doses. We reject the noninferiority hypothesis if at 24 months the lower limit of the two-sided 99% confidence interval on R ≥ 0.67 for HPV16 and HPV18. The overall Type 1 error rate for rejecting the null hypotheses for both HPV16 and HPV18 (i.e., declaring noninferiority of the 1D2V) at either time point was controlled at 0.025.|GMC Ratio|0.91|||||TWO_SIDED|99.0|0.69|1.19||||||This procedure controls the overall type one error at 0.05. We are conducting 4 one-sided tests and will spend alpha as follows: 0.005 of the alpha each for HPV16 and for HPV18 at 24 months and 0.02 of the alpha each for HPV16 and for HPV18 at 36 months. The experiment-wise significance level accounting for multiple comparisons is ≤ 0.05 because the null chance of rejection for either HPV16 or HPV18 is ≤0.01 at 24 months by the Bonferroni inequality and ≤0.04 at 36 months.||1.19|0.69|
72524380|NCT03728881|144578634|NON_INFERIORITY|Let R=GMC1/GMC3 be the ratio of geometric mean concentrations of 1 dose to 3 doses. We reject the noninferiority hypothesis if at 24 months the lower limit of the two-sided 99% confidence interval on R ≥ 0.67 for HPV16 and HPV18. The overall Type 1 error rate for rejecting the null hypotheses for both HPV16 and HPV18 (i.e., declaring noninferiority of the 1D2V) at either time point was controlled at 0.025.|GMC Ratio|0.89|||||TWO_SIDED|99.0|0.69|1.14||||||||1.14|0.69|
72524381|NCT03728881|144578634|EQUIVALENCE|The p-values test for heterogeneity in the GMC ratios estimated from the stratified analyses.|||||=|0.88||||||A p-value \<0.05 is interpreted as significantly different GMC ratios in different strata.|p-values test for heterogeneity|||||||=0.88
72524382|NCT03728881|144578635|EQUIVALENCE|We will use a Fisher Exact test to test for the difference of the seroconversion rate between one-dose and three-dose recipients enrolled April - May.|||||=|0.629||||||A p-value under 0.05 will be regarded as significant.|Fisher Exact|||The calculated p-value for the comparison of the seroconversion rate of HPV18 at 24 months between one-dose recipients and three-dose recipients enrolled April - May.||||=0.629
72524383|NCT03728881|144578635|EQUIVALENCE|We will use a Fisher Exact test to test for the difference of the seroconversion rate between one-dose and three-dose recipients enrolled June - August.|||||=|0.175||||||A p-value under 0.05 will be regarded as significant.|Fisher Exact|||The calculated p-value for the comparison of the seroconversion rate of HPV18 at 24 months between one-dose recipients and three-dose recipients enrolled June - August.||||=0.175
72524384|NCT03728881|144578637|NON_INFERIORITY|Let R=GMC1/GMC3 be the ratio of geometric mean concentrations of 1 dose to 3 doses. We reject the noninferiority hypothesis if at 36 months the lower limit of the two-sided 96% confidence interval on R ≥ 0.67 for HPV16 and HPV18. The overall Type 1 error rate for rejecting the null hypotheses for both HPV16 and HPV18 (i.e., declaring noninferiority of the 1D2V) at either time point was controlled at 0.025.)|GMC Ratio|0.52||||||96.0|0.43|0.64||||||This procedure controls the overall type one error at 0.05. We are conducting 4 one-sided tests and will spend alpha as follows: 0.005 of the alpha each for HPV16 and for HPV18 at 24 months and 0.02 of the alpha each for HPV16 and for HPV18 at 36 months. The experiment-wise significance level accounting for multiple comparisons is ≤ 0.05 because the null chance of rejection for either HPV16 or HPV18 is ≤0.01 at 24 months by the Bonferroni inequality and ≤0.04 at 36 months.||0.64|0.43|
72570948|NCT00546572|144670399|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 2-sided 95 % confidence interval for the geometric mean ratio (GMR) was \> 0.5 (2-fold criterion). Statistical significance demonstrated if the lower limit of the 2-sided 95 % confidence interval for the geometric mean ratio (GMR) was \> 1.|ratio of geometric mean titer|1.6|||||TWO_SIDED|95.0|1.17|2.06|||||Confidence intervals for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS).|Serotype 19F: ratio of GMT (13vPnC to 23vPS) calculated by back transforming the mean difference between vaccine groups on the logarithmic scale.||2.06|1.17|
72524385|NCT03728881|144578637|NON_INFERIORITY|Let R=GMC1/GMC3 be the ratio of geometric mean concentrations of 1 dose to 3 doses. We reject the noninferiority hypothesis if at 36 months the lower limit of the two-sided 96% confidence interval on R ≥ 0.67 for HPV16 and HPV18. The overall Type 1 error rate for rejecting the null hypotheses for both HPV16 and HPV18 (i.e., declaring noninferiority of the 1D2V) at either time point was controlled at 0.025.)|GMC Ratio|0.48||||||96.0|0.4|0.58||||||||0.58|0.40|
72570949|NCT00546572|144670399|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 2-sided 95 % confidence interval for the geometric mean ratio (GMR) was \> 0.5 (2-fold criterion). Statistical significance demonstrated if the lower limit of the 2-sided 95 % confidence interval for the geometric mean ratio (GMR) was \> 1.|ratio of geometric mean titer|3.7|||||TWO_SIDED|95.0|2.69|5.09|||||Confidence intervals for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS).|Serotype 23F: ratio of GMT (13vPnC to 23vPS) calculated by back transforming the mean difference between vaccine groups on the logarithmic scale.||5.09|2.69|
72570950|NCT00546572|144670400|SUPERIORITY_OR_OTHER||difference in proportions|43.8|||||TWO_SIDED|95.0|37.4|49.9|||||Exact 2-sided CI (based on Chan and Zhang) for the difference in proportions, 13vPnC - 23vPS expressed as a percentage.|"Serotype 6A: difference in proportions, 13vPnC - 23vPS, expressed as a percentage.~Statistical significance was shown if the lower limit of the 95% CI for the difference in proportions (13vPnC - 23vPS) was \> 0."||49.9|37.4|
72570951|NCT00546572|144670401|SUPERIORITY_OR_OTHER||ratio of geometric mean titer|9.6|||||TWO_SIDED|95.0|7.0|13.26|||||Confidence intervals for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS).|"Serotype 6A: ratio of GMT (13vPnC to 23vPS) calculated by back transforming the mean difference between vaccine groups on the logarithmic scale.~Statistical significance was demonstrated if the lower limit of the 2-sided 95% confidence interval for the geometric mean ratio was \>2."||13.26|7.00|
72570952|NCT00546572|144670402|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 95% confidence interval for the back-transformed GMFR was \> 0.5 (2-fold criterion).|geometric mean fold rise|1.0|||||TWO_SIDED|95.0|0.85|1.1|||||Confidence intervals are back transformations of a CI based on the student t distribution for the mean logarithm of the titers.|Serotype 1: geometric mean fold rise (GMFR) \[(13vPnC / 13vPnC) / (13vPnC)\] calculated using all participants with available data from both the postvaccination 1 and postvaccination 2 blood draws.||1.10|0.85|
72570953|NCT00546572|144670402|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 95% confidence interval for the back-transformed GMFR was \> 0.5 (2-fold criterion).|geometric mean fold rise|1.0|||||TWO_SIDED|95.0|0.91|1.11|||||Confidence intervals are back transformations of a CI based on the student t distribution for the mean logarithm of the titers.|Serotype 3: geometric mean fold rise (GMFR) \[(13vPnC / 13vPnC) / (13vPnC)\] calculated using all participants with available data from both the postvaccination 1 and postvaccination 2 blood draws.||1.11|0.91|
72625194|NCT01098747|144780079|SUPERIORITY_OR_OTHER||LS mean difference|0.3|||<|0.001|TWO_SIDED|95.0|0.13|0.46||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||0.25 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.46|0.13|<0.001
72524386|NCT03728881|144578637|EQUIVALENCE|The p-values test for heterogeneity in the GMC ratios estimated from the stratified analyses.|||||=|0.46||||||A p-value \<0.05 is interpreted as significantly different GMC ratios in different strata.|p-values test for heterogeneity|||||||=0.46
72524387|NCT03728881|144578638|EQUIVALENCE|We will use a Fisher Exact test to test for the difference of the seroconversion rate between one-dose and three-dose recipients from coastal districts.|||||=|1||||||A p-value under 0.05 will be regarded as significant.|Fisher Exact|||NOTE: One-dose recipients and three-dose recipients enrolled from mountainous districts both had a 100% seroconversion proportion for HPV16 at 36 months, so the p-value for the difference of the seroconversion rate between them could not be calculated. Therefore, we only include the calculated p-value for the comparison of the seroconversion rate for HPV16 at 36 months between one-dose recipients and three-dose recipients enrolled from coastal districts.||||=1.000
72570954|NCT00546572|144670402|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 95% confidence interval for the back-transformed GMFR was \> 0.5 (2-fold criterion).|geometric mean fold rise|0.8|||||TWO_SIDED|95.0|0.68|0.92|||||Confidence intervals are back transformations of a CI based on the student t distribution for the mean logarithm of the titers.|Serotype 4: geometric mean fold rise (GMFR) \[(13vPnC / 13vPnC) / (13vPnC)\] calculated using all participants with available data from both the postvaccination 1 and postvaccination 2 blood draws.||0.92|0.68|
72570955|NCT00546572|144670402|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 95% confidence interval for the back-transformed GMFR was \> 0.5 (2-fold criterion).|geometric mean fold rise|0.8|||||TWO_SIDED|95.0|0.73|0.94|||||Confidence intervals are back transformations of a CI based on the student t distribution for the mean logarithm of the titers.|Serotype 5: geometric mean fold rise (GMFR) \[(13vPnC / 13vPnC) / (13vPnC)\] calculated using all participants with available data from both the postvaccination 1 and postvaccination 2 blood draws.||0.94|0.73|
72570956|NCT00546572|144670402|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 95% confidence interval for the back-transformed GMFR was \> 0.5 (2-fold criterion).|geometric mean fold rise|1.2|||||TWO_SIDED|95.0|1.03|1.4|||||Confidence intervals are back transformations of a CI based on the student t distribution for the mean logarithm of the titers.|Serotype 6A: geometric mean fold rise (GMFR) \[(13vPnC / 13vPnC) / (13vPnC)\] calculated using all participants with available data from both the postvaccination 1 and postvaccination 2 blood draws.||1.40|1.03|
72625195|NCT01098747|144780079|SUPERIORITY_OR_OTHER||LS mean difference|0.22|||<|0.001|TWO_SIDED|95.0|0.11|0.34||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||0.25 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.34|0.11|<0.001
72625196|NCT01098747|144780079|SUPERIORITY_OR_OTHER||LS mean difference|0.94|||<|0.001|TWO_SIDED|95.0|0.7|1.19||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||0.5 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.19|0.70|<0.001
72524388|NCT03728881|144578640|NON_INFERIORITY|Let R=GMC1/GMC3 be the ratio of geometric mean concentrations of 1 dose to 3 doses. We reject the noninferiority hypothesis if at 36 months the lower limit of the two-sided 96% confidence interval on R ≥ 0.67 for HPV16 and HPV18. The overall Type 1 error rate for rejecting the null hypotheses for both HPV16 and HPV18 (i.e., declaring noninferiority of the 1D2V) at either time point was controlled at 0.025.)|GMC Ratio|1.27||||||96.0|1.03|1.57||||||This procedure controls the overall type one error at 0.05. We are conducting 4 one-sided tests and will spend alpha as follows: 0.005 of the alpha each for HPV16 and for HPV18 at 24 months and 0.02 of the alpha each for HPV16 and for HPV18 at 36 months. The experiment-wise significance level accounting for multiple comparisons is ≤ 0.05 because the null chance of rejection for either HPV16 or HPV18 is ≤0.01 at 24 months by the Bonferroni inequality and ≤0.04 at 36 months.||1.57|1.03|
72524389|NCT03728881|144578640|NON_INFERIORITY|Let R=GMC1/GMC3 be the ratio of geometric mean concentrations of 1 dose to 3 doses. We reject the noninferiority hypothesis if at 36 months the lower limit of the two-sided 96% confidence interval on R ≥ 0.67 for HPV16 and HPV18. The overall Type 1 error rate for rejecting the null hypotheses for both HPV16 and HPV18 (i.e., declaring noninferiority of the 1D2V) at either time point was controlled at 0.025.)|GMC Ratio|0.99||||||96.0|0.8|1.23||||||||1.23|0.80|
72524390|NCT03728881|144578640|EQUIVALENCE|The p-values test for heterogeneity in the GMC ratios estimated from the stratified analyses.|||||=|0.095||||||A p-value \<0.05 is interpreted as significantly different GMC ratios in different strata.|p-values test for heterogeneity|||||||=0.095
72524391|NCT03728881|144578641|EQUIVALENCE|We will use a Fisher Exact test to test for the difference of the seroconversion rate between one-dose and three-dose recipients enrolled from coastal districts.|||||=|0.327||||||A p-value under 0.05 will be regarded as significant.|Fisher Exact|||The calculated p-value for the comparison of the seroconversion rate for HPV18 at 36 months between one-dose recipients and three-dose recipients enrolled from coastal districts.||||=0.327
72524392|NCT03728881|144578641|EQUIVALENCE|We will use a Fisher Exact test to test for the difference of the seroconversion rate between one-dose and three-dose recipients enrolled from mountainous districts.|||||=|0.012||||||A p-value under 0.05 will be regarded as significant.|Fisher Exact|||The calculated p-value for the comparison of the seroconversion rate for HPV18 at 36 months between one-dose recipients and three-dose recipients enrolled from mountainous districts.||||=0.012
72524393|NCT03728881|144578643|NON_INFERIORITY|Let R=GMC1/GMC3 be the ratio of geometric mean concentrations of 1 dose to 3 doses. We reject the noninferiority hypothesis if at 24 months the lower limit of the two-sided 99% confidence interval on R ≥ 0.67 for HPV16 and HPV18. The overall Type 1 error rate for rejecting the null hypotheses for both HPV16 and HPV18 (i.e., declaring noninferiority of the 1D2V) at either time point was controlled at 0.025.|GMC Ratio|0.45|||||TWO_SIDED|99.0|0.36|0.58||||||||0.58|0.36|
72524394|NCT03728881|144578643|NON_INFERIORITY|Let R=GMC1/GMC3 be the ratio of geometric mean concentrations of 1 dose to 3 doses. We reject the noninferiority hypothesis if at 24 months the lower limit of the two-sided 99% confidence interval on R ≥ 0.67 for HPV16 and HPV18. The overall Type 1 error rate for rejecting the null hypotheses for both HPV16 and HPV18 (i.e., declaring noninferiority of the 1D2V) at either time point was controlled at 0.025.|GMC Ratio|0.4|||||TWO_SIDED|99.0|0.32|0.5||||||||0.50|0.32|
72524395|NCT03728881|144578643|EQUIVALENCE|The p-values test for heterogeneity in the GMC ratios estimated from the stratified analyses.|||||=|0.3||||||A p-value \<0.05 is interpreted as significantly different GMC ratios in different strata.|p-values test for heterogeneity|||||||=0.30
72524396|NCT03728881|144578644|EQUIVALENCE|We will use a Fisher Exact test to test for the difference of the seroconversion rate between one-dose and three-dose recipients enrolled from coastal districts.|||||=|1||||||A p-value under 0.05 will be regarded as significant.|Fisher Exact|||NOTE: One-dose recipients and three-dose recipients enrolled from mountainous districts had a 100% seroconversion proportion for HPV16 at 24 months, so the p-value for the difference of the seroconversion rate between them could not be calculated. Therefore, we only include the calculated p-value for the comparison of the seroconversion rate for HPV16 at 24 months between one-dose recipients and three-dose recipients enrolled from coastal districts.||||=1.000
72524397|NCT03728881|144578646|NON_INFERIORITY|Let R=GMC1/GMC3 be the ratio of geometric mean concentrations of 1 dose to 3 doses. We reject the noninferiority hypothesis if at 24 months the lower limit of the two-sided 99% confidence interval on R ≥ 0.67 for HPV16 and HPV18. The overall Type 1 error rate for rejecting the null hypotheses for both HPV16 and HPV18 (i.e., declaring noninferiority of the 1D2V) at either time point was controlled at 0.025.|GMC Ratio|1.02||||||99.0|0.79|1.32||||||This procedure controls the overall type one error at 0.05. We are conducting 4 one-sided tests and will spend alpha as follows: 0.005 of the alpha each for HPV16 and for HPV18 at 24 months and 0.02 of the alpha each for HPV16 and for HPV18 at 36 months. The experiment-wise significance level accounting for multiple comparisons is ≤ 0.05 because the null chance of rejection for either HPV16 or HPV18 is ≤0.01 at 24 months by the Bonferroni inequality and ≤0.04 at 36 months.||1.32|0.79|
72625197|NCT01098747|144780079|SUPERIORITY_OR_OTHER||LS mean difference|0.38|||<|0.001|TWO_SIDED|95.0|0.2|0.55||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||0.5 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.55|0.20|<0.001
72524398|NCT03728881|144578646|NON_INFERIORITY|Let R=GMC1/GMC3 be the ratio of geometric mean concentrations of 1 dose to 3 doses. We reject the noninferiority hypothesis if at 24 months the lower limit of the two-sided 99% confidence interval on R ≥ 0.67 for HPV16 and HPV18. The overall Type 1 error rate for rejecting the null hypotheses for both HPV16 and HPV18 (i.e., declaring noninferiority of the 1D2V) at either time point was controlled at 0.025.|GMC Ratio|0.81||||||99.0|0.63|1.04||||||||1.04|0.63|
72524399|NCT03728881|144578646|EQUIVALENCE|The p-values test for heterogeneity in the GMC ratios estimated from the stratified analyses.|||||=|0.1||||||A p-value \<0.05 is interpreted as significantly different GMC ratios in different strata.|p-values test for heterogeneity|||||||=0.10
72625198|NCT01098747|144780079|SUPERIORITY_OR_OTHER||LS mean difference|1.46|||<|0.001|TWO_SIDED|95.0|1.18|1.75||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1 hour: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.75|1.18|<0.001
72524400|NCT03728881|144578647|EQUIVALENCE|We will use a Fisher Exact test to test for the difference of the seroconversion rate between one-dose and three-dose recipients enrolled from coastal districts.|||||=|1||||||A p-value under 0.05 will be regarded as significant.|Fisher Exact|||The calculated p-value for the comparison of the seroconversion rate for HPV18 at 24 months between one-dose recipients and three-dose recipients enrolled from coastal districts.||||=1.000
72524401|NCT03728881|144578647|EQUIVALENCE|We will use a Fisher Exact test to test for the difference of the seroconversion rate between one-dose and three-dose recipients enrolled from mountainous districts.|||||=|0.339||||||A p-value under 0.05 will be regarded as significant.|Fisher Exact|||The calculated p-value for the comparison of the seroconversion rate for HPV18 at 24 months between one-dose recipients and three-dose recipients enrolled from mountainous districts.||||=0.339
72524402|NCT05505734|144578710|SUPERIORITY||Hazard Ratio (HR)|0.535|||<|0.001|TWO_SIDED|95.0|0.392|0.73||The pre-specified alpha (type I error) at the IA was set at 0.003 for the primary and first secondary endpoint|Regression, Cox|||Hazard ratios, 95% confidence intervals for hazard ratios and p-values are estimated using a Cox regression model with treatment group, pre-study asthma therapy, and number of severe exacerbations in the last 12 months prior to randomization as factors. A hazard ratio less than 1 favors the BDA MDI treatment group.||0.730|0.392|<0.001
72524403|NCT05505734|144578711|SUPERIORITY||Hazard Ratio (HR)|0.539|||<|0.001|TWO_SIDED|95.0|0.397|0.733||The pre-specified alpha (type I error) at the IA was set at 0.003 for the primary and first secondary endpoint|Regression, Cox|||Hazard ratios, 95% confidence intervals for hazard ratios and p-values were estimated using a Cox regression model with treatment group, pre-study asthma therapy, and number of severe exacerbations in the last 12 months prior to randomization as factors. A hazard ratio less than 1 favors the BDA MDI treatment group.||0.733|0.397|<0.001
72524404|NCT05505734|144578712|SUPERIORITY||Hazard Ratio (HR)|0.541|||<|0.001|TWO_SIDED|95.0|0.405|0.724||The pre-specified type I error for secondary endpoints tested at the final DCO was 0.05. A hierarchical testing strategy was employed to control the two-sided Type I error rate for the secondary endpoints, excluding the first secondary endpoint.|Regression, Cox|||Hazard ratios, 95% confidence intervals for hazard ratios and p-values were estimated using a Cox regression model with treatment group, pre-study asthma therapy, and number of severe exacerbations in the last 12 months prior to randomization as factors. A hazard ratio less than 1 favors the BDA MDI treatment group.||0.724|0.405|<0.001
72524405|NCT05505734|144578713|SUPERIORITY||Hazard Ratio (HR)|0.541|||<|0.001|TWO_SIDED|95.0|0.406|0.72||The pre-specified type I error for secondary endpoints tested at the final DCO was 0.05. A hierarchical testing strategy was employed to control the two-sided Type I error rate for the secondary endpoints, excluding the first secondary endpoint.|Regression, Cox|||Hazard ratios, 95% confidence intervals for hazard ratios and p-values were estimated using a Cox regression model with treatment group, pre-study asthma therapy, and number of severe exacerbations in the last 12 months prior to randomization as factors. A hazard ratio less than 1 favors the BDA MDI treatment group.||0.720|0.406|<0.001
72524406|NCT05505734|144578714|SUPERIORITY||Rate Ratio|0.47|||<|0.001|TWO_SIDED|95.0|0.34|0.64||The pre-specified type I error for secondary endpoints tested at the final DCO was 0.05. A hierarchical testing strategy was employed to control the two-sided Type I error rate for the secondary endpoints, excluding the first secondary endpoint.|Negative binomial|||Rates, rate ratios and two-sided p-values were estimated from a negative binomial model with treatment, pre-study asthma therapy, and number of severe exacerbations in the last 12 months prior to randomization as factors. A rate ratio less than 1 favors BDA MDI treatment group.||0.64|0.34|<0.001
72524407|NCT05505734|144578715|SUPERIORITY||Rate Ratio|0.46|||<|0.001|TWO_SIDED|95.0|0.33|0.63||The pre-specified type I error for secondary endpoints tested at the final DCO was 0.05. A hierarchical testing strategy was employed to control the two-sided Type I error rate for the secondary endpoints, excluding the first secondary endpoint.|Negative binomial|||Rates, rate ratios and two-sided p-values were estimated from a negative binomial model with treatment, pre-study asthma therapy, and number of severe exacerbations in the last 12 months prior to randomization as factors. A rate ratio less than 1 favors BDA MDI treatment group.||0.63|0.33|<0.001
72524408|NCT05505734|144578716|SUPERIORITY||||||<|0.001||||||The pre-specified type I error for secondary endpoints tested at the final DCO was 0.05. A hierarchical testing strategy was employed to control the two-sided Type I error rate for the secondary endpoints, excluding the first secondary endpoint.|Wilcoxon rank sum|||||||<0.001
72524409|NCT05505734|144578717|SUPERIORITY||||||<|0.001||||||The pre-specified type I error for secondary endpoints tested at the final DCO was 0.05. A hierarchical testing strategy was employed to control the two-sided Type I error rate for the secondary endpoints, excluding the first secondary endpoint.|Wilcoxon rank sum|||||||<0.001
72570957|NCT00546572|144670402|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 95% confidence interval for the back-transformed GMFR was \> 0.5 (2-fold criterion).|geometric mean fold rise|1.2|||||TWO_SIDED|95.0|1.02|1.35|||||Confidence intervals are back transformations of a CI based on the student t distribution for the mean logarithm of the titers.|Serotype 6B: geometric mean fold rise (GMFR) \[(13vPnC / 13vPnC) / (13vPnC)\] calculated using all participants with available data from both the postvaccination 1 and postvaccination 2 blood draws.||1.35|1.02|
72625199|NCT01098747|144780079|SUPERIORITY_OR_OTHER||LS mean difference|0.25||||0.017|TWO_SIDED|95.0|0.04|0.45||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1 hour: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.45|0.04|0.017
72524410|NCT00554853|144578727|SUPERIORITY_OR_OTHER|||||||0.63|||||||ANCOVA|||||||0.63
72524411|NCT01899768|144578782|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric mean|1.26|||||TWO_SIDED|90.0|1.1|1.44|||||Ratio of adjusted geometric means = GSK2339345/Placebo.|||1.44|1.10|
72570958|NCT00546572|144670402|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 95% confidence interval for the back-transformed GMFR was \> 0.5 (2-fold criterion).|geometric mean fold rise|0.8|||||TWO_SIDED|95.0|0.65|1.01|||||Confidence intervals are back transformations of a CI based on the student t distribution for the mean logarithm of the titers.|Serotype 7F: geometric mean fold rise (GMFR) \[(13vPnC / 13vPnC) / (13vPnC)\] calculated using all participants with available data from both the postvaccination 1 and postvaccination 2 blood draws.||1.01|0.65|
72524412|NCT01899768|144578783|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric mean|1.02|||||TWO_SIDED|90.0|0.87|1.19|||||Ratio of adjusted geometric means = GSK2339345/Placebo.|||1.19|0.87|
72524413|NCT01899768|144578806|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric mean|1.23|||||TWO_SIDED|90.0|0.86|1.75|||||Ratio of adjusted geometric means = GSK2339345/Placebo. Estimated value and CI are presented for the mean cough count over 0-4 hr.|||1.75|0.86|
72524414|NCT01899768|144578806|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric mean|1.36|||||TWO_SIDED|90.0|1.07|1.72|||||Ratio of adjusted geometric means = GSK2339345/Placebo. Estimated value and CI are presented for the mean cough count over 4-8 hr.|||1.72|1.07|
72524415|NCT01899768|144578807|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric mean|0.97|||||TWO_SIDED|90.0|0.67|1.4|||||Ratio of adjusted geometric means = GSK2339345/Placebo. Estimated value and CI are presented for the mean cough count over 0-4 hr.|||1.40|0.67|
72524416|NCT01899768|144578807|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means = GSK2|1.04|||||TWO_SIDED|90.0|0.79|1.36|||Ratio of adjusted geometric mean|||||1.36|0.79|
72524417|NCT02203916|144578818|SUPERIORITY_OR_OTHER||LS Mean Difference|-13.317|STANDARD_ERROR_OF_MEAN|2.4502|<|0.001|TWO_SIDED|95.0|-18.138|-8.497||"Overall type 1 error rate of 0.05 was controlled using principle of 'closed' testing: each pairwise comparison to placebo was conducted at 0.05 level with no p-value adjustment if hypothesis all treatment groups equal was first rejected at 0.05."|ANCOVA|Post-baseline p-values were from an ANCOVA model with treatment as a fixed factor and baseline values as a continuous covariate.||||-8.497|-18.138|<0.001
72524418|NCT02203916|144578818|SUPERIORITY_OR_OTHER||LS Mean Difference|-14.955|STANDARD_ERROR_OF_MEAN|2.447|<|0.001|TWO_SIDED|95.0|-19.77|-10.141||"Overall type 1 error rate of 0.05 was controlled using principle of 'closed' testing: each pairwise comparison to placebo was conducted at 0.05 level with no p-value adjustment if hypothesis all treatment groups equal was first rejected at 0.05."|ANCOVA|Post-baseline p-values were from an ANCOVA model with treatment as a fixed factor and baseline values as a continuous covariate.||||-10.141|-19.770|<0.001
72524419|NCT00414973|144578840|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.39|STANDARD_ERROR_OF_MEAN|0.76|<|0.0001||95.0|2.89|5.89||There were no adjustments for multiple comparisons.|ANCOVA||Difference = Teriparatide minus Calcitonin|Null hypothesis=no difference between percentage changes from baseline in lumbar spine bone mineral density for female patients receiving teriparatide compared to female patients receiving calcitonin.||5.89|2.89|<0.0001
72524420|NCT00414973|144578841|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.08|STANDARD_ERROR_OF_MEAN|0.7||0.9062||95.0|-1.3|1.46|||ANCOVA||Difference = Teriparatide minus Calcitonin|||1.46|-1.30|0.9062
72524421|NCT00414973|144578842|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||P-value for Week 12 Percentage Change.|Wilcoxon Rank-Sum Test|||||||<0.0001
72524422|NCT00414973|144578842|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||P-value for Week 24 Percentage Change.|Wilcoxon Rank-Sum Test|||||||<0.0001
72524423|NCT00414973|144578843|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.63|STANDARD_ERROR_OF_MEAN|2.2||0.2409||95.0|-1.87|7.13|||ANCOVA||Difference = Teriparatide minus Calcitonin|||7.13|-1.87|0.2409
72524424|NCT00414973|144578844|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.96|STANDARD_ERROR_OF_MEAN|1.9||0.6156||95.0|-4.85|2.92|||ANCOVA||Difference = Teriparatide minus Calcitonin|||2.92|-4.85|0.6156
72524425|NCT00414973|144578845|SUPERIORITY_OR_OTHER|||||||0.0026||95.0||||P-value for Week 12 Percentage Change.|Wilcoxon Rank-Sum Test|||||||0.0026
72524426|NCT00414973|144578845|SUPERIORITY_OR_OTHER|||||||0.0006||95.0||||P-value for 24 Week Percentage Change.|Wilcoxon Rank-Sum Test|||||||0.0006
72524427|NCT03236506|144578846|NON_INFERIORITY|Assuming a 95% SVR rate (based on published studies) in the DOT arm of the trial in this population and a non-inferiority limit of 14% (which would be likely to maintain cost-effectiveness) then at a 5% significance level and 90% power we would need a sample size of 42 in each group 126 in total. To allow for drop-outs we will aim to recruit 135 individuals, 45 per group.|Odds Ratio (OR)|0.64||||0.67|TWO_SIDED|95.0|0.14|3.0|||Logistic|||||3.00|0.14|0.67
72524428|NCT03236506|144578846|NON_INFERIORITY|Described in Statistical Analysis 1.|Odds Ratio (OR)|0.53||||0.41|TWO_SIDED|95.0|0.11|2.45|||logistic|||||2.45|0.11|0.41
72524429|NCT03236506|144578846|NON_INFERIORITY|Described in Statistical Analysis 1.|Odds Ratio (OR)|1.22||||0.82|TWO_SIDED|95.0|0.23|6.61|||logistic|||||6.61|0.23|0.82
72524430|NCT03152110|144578886|SUPERIORITY|||||||0.203|||||||t-test, 2 sided|||||||.203
72524431|NCT03152110|144578887|SUPERIORITY|||||||0.931|||||||t-test, 2 sided|||||||0.931
72524432|NCT00850135|144578946|SUPERIORITY_OR_OTHER|||||||0.035|TWO_SIDED|||||p-Value for the correlation between AUC-110 and birth weight|correlation|||||||0.035
72625200|NCT01098747|144780079|SUPERIORITY_OR_OTHER||LS mean difference|1.67|||<|0.001|TWO_SIDED|95.0|1.39|1.96||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1.5 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.96|1.39|<0.001
72524433|NCT02213081|144578951|EQUIVALENCE|Wilcoxon signed rank test was used to determine if the mean difference in pain scores before compared to during ulipristal therapy were equivalent or non-equivalent.|Mean Difference (Net)|3.5|STANDARD_ERROR_OF_MEAN|0.57|<|0.05|TWO_SIDED||||||Wilcoxon signed rank|||||||<0.05
72524434|NCT04157751|144579009|OTHER||Stratified Win Ratio|1.36||||0.0027|TWO_SIDED|95.0|1.09|1.68||p-value for WR\<=1.0 (one-sided), variance calculated using the asymptotic normal U statistics approach.|Asymptotic normal U statistics approach||WR estimate= \[((a)+(c)+(e)+(g)) / ((b)+(d)+(f)+(h))\]|"Stratified win ratio (WR) was used, calculated as total number of wins in the empa group across all strata divided by total number of losses. Weights were applied analogous to a Mantel-Haenszel approach.~1. death in pbo first;~2. death in empa first;~3. HFEs in pbo more frequently;~4. HFEs in empa more frequently;~5. HFEs in pbo first;~6. HFEs in empa first;~7. KCCQ-TSS change lower in pbo;~8. KCCQ-TSS change lower in empa"||1.68|1.09|0.0027
72524435|NCT04157751|144579010|OTHER||Odds Ratio (OR)|1.522|STANDARD_ERROR_OF_MEAN|0.386||0.097|TWO_SIDED|95.0|0.927|2.501||p-value for OR=1.0 (two-sided).|Regression, Logistic|Wald Confidence interval.|Comparison vs. Placebo.|Logistic regression including terms for baseline KCCQ-TSS, treatment and heart failure status||2.501|0.927|0.0970
72524436|NCT04157751|144579011|OTHER||Difference of adjusted mean|4.45|STANDARD_ERROR_OF_MEAN|2.1||0.0347|TWO_SIDED|95.0|0.32|8.59||p-value for difference = 0 (two-sided)|Mixed Models Analysis|||Restricted maximum likelihood estimation based on a mixed-effect model for repeated measures (MMRM) analysis to obtain adjusted means for the treatment effects. This model included discrete fixed effects for treatment group, and heart failure status at each visit and continuous fixed effects for baseline value at each visit. Missing data caused by patient withdrawal or other reasons were handled implicitly by the MMRM approach. Unstructured covariance structure was used.||8.59|0.32|0.0347
72570959|NCT00546572|144670402|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 95% confidence interval for the back-transformed GMFR was \> 0.5 (2-fold criterion).|geometric mean fold rise|0.9|||||TWO_SIDED|95.0|0.69|1.15|||||Confidence intervals are back transformations of a CI based on the student t distribution for the mean logarithm of the titers.|Serotype 9V: geometric mean fold rise (GMFR) \[(13vPnC / 13vPnC) / (13vPnC)\] calculated using all participants with available data from both the postvaccination 1 and postvaccination 2 blood draws.||1.15|0.69|
72625201|NCT01098747|144780079|SUPERIORITY_OR_OTHER||LS mean difference|0.25||||0.015|TWO_SIDED|95.0|0.05|0.46||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1.5 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.46|0.05|0.015
72625202|NCT01098747|144780079|SUPERIORITY_OR_OTHER||LS mean difference|1.69|||<|0.001|TWO_SIDED|95.0|1.41|1.98||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||2 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.98|1.41|<0.001
72524437|NCT04157751|144579012|OTHER||Adjusted geometric mean ratio|0.9||||0.0176|TWO_SIDED|95.0|0.82|0.98|||ANCOVA|ANCOVA with a discrete fixed effect for heart failure status and a continuous fixed effect for baseline NT-proBNP level.|Comparison vs. Placebo|Area under the curve (AUC) of change from baseline in log-transformed NT-proBNP level over 30 days of treatment was analysed by an analysis of covariance (ANCOVA). NT-proBNP level is regarded as log-normally distributed, therefore values were log-transformed prior to analysis. The linear trapezoidal rule was used to calculate the AUC after the log-transformation had been applied to each value.||0.98|0.82|0.0176
72524438|NCT04157751|144579015|OTHER||Hazard Ratio (HR)|0.71||||0.1241|TWO_SIDED|95.0|0.46|1.1||p-value for HR=1.0 (two sided)|Regression, Cox|Cox proportional hazard model with terms for heart failure status and treatment.|Comparison vs. Placebo.|||1.10|0.46|0.1241
72524439|NCT01302691|144579023|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-1.1||||0.205|TWO_SIDED|95.0|-2.7|0.6|||Constrained Longitudinal Data Analysis|Model includes treatment group, time point, and the interaction of time by treatment with restriction of same baseline mean across treatment groups||||0.6|-2.7|0.205
72524440|NCT01302691|144579029|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-3.2||||0.011|TWO_SIDED|95.0|-5.7|-0.8|||Constrained Longitudinal Data Analysis|Model includes treatment group, time point, and the interaction of time by treatment with restriction of same baseline mean across treatment groups||||-0.8|-5.7|0.011
72524441|NCT00423592|144579030|SUPERIORITY_OR_OTHER||Proportion|0.0|STANDARD_DEVIATION|0.0||0.01|TWO_SIDED|95.0|0.0|9.7|||Exact binomial test|A 1-sample test for a binomial proportion was performed.||Sample size: 30 participants; 80% power to rule out 50% recurrence rate of serum ALT/AST abnormalities following ambrisentan treatment (assumes 25% recurrence rate); 99% power to rule out 75% recurrence rate (assumes 37.5% recurrence rate). H\_0 = proportion of subjects experiencing primary endpoint at 12% vs 1-sided alternative of \< 12%. P-value from exact binomial test. Summary statistics included the estimated proportion, 95% confidence interval (CI), and the p-value of the hypothesis test.||9.7|0.0|0.01
72524442|NCT00423592|144579033|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|23.4|STANDARD_DEVIATION|49.6||0.009|TWO_SIDED|95.0|6.3|40.4|||t-test, 2 sided|||Hypothesis testing and descriptive statistics were carried out on the last-observation-carried-forward (LOCF) 6-minute walk distance change from baseline.||40.4|6.3|0.009
72524443|NCT00423592|144579034|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5|STANDARD_DEVIATION|1.51||0.046|TWO_SIDED|95.0|-1.0|0.0|||t-test, 2 sided|||Hypothesis testing and descriptive statistics were carried out on the last-observation-carried-forward (LOCF) Borg dyspnea index change from baseline.||0.0|-1.0|0.046
72524444|NCT00423592|144579036|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.6|STANDARD_DEVIATION|6.44||0.001|TWO_SIDED|95.0|2.1|7.1|||t-test, 2 sided|||Seven subjects were evaluated by the incorrect version of the SF-36 questionnaire at the baseline visit and were not included in the analysis; therefore n = 28 for mean baseline scores, and n = 28 for mean change from baseline at Week 12.||7.1|2.1|0.001
72524445|NCT00423592|144579037|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.4|STANDARD_DEVIATION|8.98||0.059|TWO_SIDED|95.0|-0.1|6.8|||t-test, 2 sided|||Seven subjects were evaluated by the incorrect version of the SF-36 questionnaire at the baseline visit and were not included in the analysis; therefore n = 28 for mean baseline scores, and n = 28 for mean change from baseline at Week 12.||6.8|-0.1|0.059
72524446|NCT00423592|144579038|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.4|STANDARD_DEVIATION|6.86||0.002|TWO_SIDED|95.0|1.7|7.0|||t-test, 2 sided|||Seven subjects were evaluated by the incorrect version of the SF-36 questionnaire at the baseline visit and were not included in the analysis; therefore n = 28 for mean baseline scores, and n = 28 for mean change from baseline at Week 12.||7.0|1.7|0.002
72524447|NCT00423592|144579039|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.2|STANDARD_DEVIATION|10.56||0.001|TWO_SIDED|95.0|3.1|11.3|||t-test, 2 sided|||Seven subjects were evaluated by the incorrect version of the SF-36 questionnaire at the baseline visit and were not included in the analysis; therefore n = 28 for mean baseline scores, and n = 28 for mean change from baseline at Week 12.||11.3|3.1|0.001
72570960|NCT00546572|144670402|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 95% confidence interval for the back-transformed GMFR was \> 0.5 (2-fold criterion).|geometric mean fold rise|0.9|||||TWO_SIDED|95.0|0.79|1.05|||||Confidence intervals are back transformations of a CI based on the student t distribution for the mean logarithm of the titers.|Serotype 14: geometric mean fold rise (GMFR) \[(13vPnC / 13vPnC) / (13vPnC)\] calculated using all participants with available data from both the postvaccination 1 and postvaccination 2 blood draws.||1.05|0.79|
72570961|NCT00546572|144670402|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 95% confidence interval for the back-transformed GMFR was \> 0.5 (2-fold criterion).|geometric mean fold rise|1.1|||||TWO_SIDED|95.0|0.97|1.23|||||Confidence intervals are back transformations of a CI based on the student t distribution for the mean logarithm of the titers.|Serotype 18C: geometric mean fold rise (GMFR) \[(13vPnC / 13vPnC) / (13vPnC)\] calculated using all participants with available data from both the postvaccination 1 and postvaccination 2 blood draws.||1.23|0.97|
72570962|NCT00546572|144670402|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 95% confidence interval for the back-transformed GMFR was \> 0.5 (2-fold criterion).|geometric mean fold rise|1.0|||||TWO_SIDED|95.0|0.89|1.07|||||Confidence intervals are back transformations of a CI based on the student t distribution for the mean logarithm of the titers.|Serotype 19A: geometric mean fold rise (GMFR) \[(13vPnC / 13vPnC) / (13vPnC)\] calculated using all participants with available data from both the postvaccination 1 and postvaccination 2 blood draws.||1.07|0.89|
72570963|NCT00546572|144670402|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 95% confidence interval for the back-transformed GMFR was \> 0.5 (2-fold criterion).|geometric mean fold rise|1.0|||||TWO_SIDED|95.0|0.83|1.15|||||Confidence intervals are back transformations of a CI based on the student t distribution for the mean logarithm of the titers.|Serotype 19F: geometric mean fold rise (GMFR) \[(13vPnC / 13vPnC) / (13vPnC)\] calculated using all participants with available data from both the postvaccination 1 and postvaccination 2 blood draws.||1.15|0.83|
72570964|NCT00546572|144670402|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 95% confidence interval for the back-transformed GMFR was \> 0.5 (2-fold criterion).|geometric mean fold rise|1.9|||||TWO_SIDED|95.0|1.6|2.14|||||Confidence intervals are back transformations of a CI based on the student t distribution for the mean logarithm of the titers.|Serotype 23F: geometric mean fold rise (GMFR) \[(13vPnC / 13vPnC) / (13vPnC)\] calculated using all participants with available data from both the postvaccination 1 and postvaccination 2 blood draws.||2.14|1.60|
72625203|NCT01098747|144780079|SUPERIORITY_OR_OTHER||LS mean difference|0.09||||0.362|TWO_SIDED|95.0|-0.11|0.3||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||2 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.30|-0.11|0.362
72625204|NCT01098747|144780079|SUPERIORITY_OR_OTHER||LS mean difference|1.56|||<|0.001|TWO_SIDED|95.0|1.27|1.86||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||3 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.86|1.27|<0.001
72625205|NCT01098747|144780079|SUPERIORITY_OR_OTHER||LS mean difference|-0.08||||0.472|TWO_SIDED|95.0|-0.29|0.14||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||3 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.14|-0.29|0.472
72406496|NCT02942017|144321622|SUPERIORITY||LS Mean Difference|-0.36|STANDARD_ERROR_OF_MEAN|0.138||0.0108|TWO_SIDED|95.0|-0.63|-0.08|||MMRM|||Somatic Symptoms General, Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.08|-0.63|0.0108
72524448|NCT00423592|144579040|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.1|STANDARD_DEVIATION|6.4||0.017|TWO_SIDED|95.0|0.6|5.6|||t-test, 2 sided|||Seven subjects were evaluated by the incorrect version of the SF-36 questionnaire at the baseline visit and were not included in the analysis; therefore n = 28 for mean baseline scores, and n = 28 for mean change from baseline at Week 12.||5.6|0.6|0.017
72524449|NCT00423592|144579041|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.0|STANDARD_DEVIATION|7.45||0.046|TWO_SIDED|95.0|0.1|5.8|||t-test, 2 sided|||Seven subjects were evaluated by the incorrect version of the SF-36 questionnaire at the baseline visit and were not included in the analysis; therefore n = 28 for mean baseline scores, and n = 28 for mean change from baseline at Week 12.||5.8|0.1|0.046
72524450|NCT00423592|144579042|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.5|STANDARD_DEVIATION|7.23||0.003|TWO_SIDED|95.0|1.7|7.3|||t-test, 2 sided|||Seven subjects were evaluated by the incorrect version of the SF-36 questionnaire at the baseline visit and were not included in the analysis; therefore n = 28 for mean baseline scores, and n = 28 for mean change from baseline at Week 12.||7.3|1.7|0.003
72625206|NCT01098747|144780079|SUPERIORITY_OR_OTHER||LS mean difference|1.39|||<|0.001|TWO_SIDED|95.0|1.07|1.7||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||4 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.70|1.07|<0.001
72524451|NCT00423592|144579043|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.5|STANDARD_DEVIATION|9.41||0.059|TWO_SIDED|95.0|-0.1|7.2|||t-test, 2 sided|||Seven subjects were evaluated by the incorrect version of the SF-36 questionnaire at the baseline visit and were not included in the analysis; therefore n = 28 for mean baseline scores, and n = 28 for mean change from baseline at Week 12.||7.2|-0.1|0.059
72524452|NCT00423592|144579044|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.9|STANDARD_DEVIATION|13.96||0.152|TWO_SIDED|95.0|-1.5|9.3|||t-test, 2 sided|||Seven subjects were evaluated by the incorrect version of the SF-36 questionnaire at the baseline visit and were not included in the analysis; therefore n = 28 for mean baseline scores, and n = 28 for mean change from baseline at Week 12.||9.3|-1.5|0.152
72570965|NCT00546572|144670403|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 2-sided 95 % confidence interval for the geometric mean ratio (GMR) was \> 0.5 (2-fold criterion).|ratio of geometric mean titer|1.4|||||TWO_SIDED|95.0|1.1|1.76|||||Confidence intervals for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC / 13vPnC )- (23vPS)\].|Serotype 1: ratio of GMT (13vPnC / 13vPnC to 23vPS) calculated by back transforming the mean difference between vaccine groups on the logarithmic scale.||1.76|1.10|
72524453|NCT00423592|144579045|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.9|STANDARD_DEVIATION|5.78||0.001|TWO_SIDED|95.0|1.7|6.2|||t-test, 2 sided|||Seven subjects were evaluated by the incorrect version of the SF-36 questionnaire at the baseline visit and were not included in the analysis; therefore n = 28 for mean baseline scores, and n = 28 for mean change from baseline at Week 12.||6.2|1.7|0.001
72524454|NCT03446612|144579046|OTHER||FBF ratio difference|0.6953|STANDARD_DEVIATION|0.12998|||||||||||The difference between daprodustat and darbepoetin alfa FBF ratio in response to acetylcholine (7.5 ug/min) is presented.|||||
72524455|NCT03446612|144579046|OTHER||FBF ratio difference|0.1683|||||||||||||The difference between daprodustat and darbepoetin alfa FBF ratio in response to acetylcholine (15 ug/min) is presented.|||||
72524456|NCT03446612|144579046|OTHER||FBF ratio difference|0.3238|||||||||||||The difference between daprodustat and darbepoetin alfa FBF ratio in response to acetylcholine (30 ug/min) is presented.|||||
72406497|NCT02942017|144321622|SUPERIORITY||LS Mean Difference|-0.28|STANDARD_ERROR_OF_MEAN|0.16||0.0889|TWO_SIDED|95.0|-0.59|0.04|||MMRM|||Somatic Symptoms General, Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.04|-0.59|0.0889
72524457|NCT03446612|144579048|OTHER||FBF ratio difference|0.2968|||||||||||||The difference between daprodustat and darbepoetin alfa FBF ratio in response to sodium nitroprusside (3 ug/min) is presented.|||||
72524458|NCT03446612|144579048|OTHER||FBF ratio difference|1.4425|||||||||||||The difference between daprodustat and darbepoetin alfa FBF ratio in response to sodium nitroprusside (10 ug/min) is presented.|||||
72524459|NCT03446612|144579050|OTHER||FBF ratio difference|-0.1598|||||||||||||The difference between daprodustat and darbepoetin alfa FBF ratio in response to L-NMMA (2 umol/min) is presented.|||||
72524460|NCT03446612|144579050|OTHER||FBF ratio difference|-0.3715|||||||||||||The difference between daprodustat and darbepoetin alfa FBF ratio in response to L-NMMA (8 umol/min) is presented.|||||
72542563|NCT01893983|144614964|EQUIVALENCE|Compare whether 2 groups had any difference in risk/hazard of mental health engagement at any time during follow-up.|Cox Proportional Hazard|1.13||||0.66|TWO_SIDED|95.0|0.81|1.58||P value 0.05 is the threshold for statistical significance|Regression, Cox|Adjusted for site, mental health treatment history and mental health symptom severity at baseline, baseline amphetamine and opioid scores.|The referral alone arm is the reference group (denominator), and the motivational coaching arm is the numerator.|Compare 2 groups in regard to time to first mental health treatment using Cox proportional hazards regression.||1.58|0.81|0.660
72570966|NCT00546572|144670403|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 2-sided 95 % confidence interval for the geometric mean ratio (GMR) was \> 0.5 (2-fold criterion).|ratio of geometric mean titer|1.1|||||TWO_SIDED|95.0|0.91|1.34|||||Confidence intervals for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC / 13vPnC )- (23vPS)\].|Serotype 3: ratio of GMT (13vPnC / 13vPnC to 23vPS) calculated by back transforming the mean difference between vaccine groups on the logarithmic scale.||1.34|0.91|
72570967|NCT00546572|144670403|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 2-sided 95 % confidence interval for the geometric mean ratio (GMR) was \> 0.5 (2-fold criterion).|ratio of geometric mean titer|2.3|||||TWO_SIDED|95.0|1.66|3.25|||||Confidence intervals for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC / 13vPnC )- (23vPS)\].|Serotype 4: ratio of GMT (13vPnC / 13vPnC to 23vPS) calculated by back transforming the mean difference between vaccine groups on the logarithmic scale.||3.25|1.66|
72570968|NCT00546572|144670403|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 2-sided 95 % confidence interval for the geometric mean ratio (GMR) was \> 0.5 (2-fold criterion).|ratio of geometric mean titer|1.6|||||TWO_SIDED|95.0|1.21|2.06|||||Confidence intervals for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC / 13vPnC )- (23vPS)\].|Serotype 5: ratio of GMT (13vPnC / 13vPnC to 23vPS) calculated by back transforming the mean difference between vaccine groups on the logarithmic scale.||2.06|1.21|
72570969|NCT00546572|144670403|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 2-sided 95 % confidence interval for the geometric mean ratio (GMR) was \> 0.5 (2-fold criterion).|ratio of geometric mean titer|3.8|||||TWO_SIDED|95.0|2.78|5.07|||||Confidence intervals for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC / 13vPnC )- (23vPS)\].|Serotype 6B: ratio of GMT (13vPnC / 13vPnC to 23vPS) calculated by back transforming the mean difference between vaccine groups on the logarithmic scale.||5.07|2.78|
72570970|NCT00546572|144670403|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 2-sided 95 % confidence interval for the geometric mean ratio (GMR) was \> 0.5 (2-fold criterion).|ratio of geometric mean titer|1.2|||||TWO_SIDED|95.0|0.8|1.67|||||Confidence intervals for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC / 13vPnC )- (23vPS)\].|Serotype 7F: ratio of GMT (13vPnC / 13vPnC to 23vPS) calculated by back transforming the mean difference between vaccine groups on the logarithmic scale.||1.67|0.80|
72570971|NCT00546572|144670403|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 2-sided 95 % confidence interval for the geometric mean ratio (GMR) was \> 0.5 (2-fold criterion).|ratio of geometric mean titer|1.8|||||TWO_SIDED|95.0|1.18|2.62|||||Confidence intervals for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC / 13vPnC )- (23vPS)\].|Serotype 9V: ratio of GMT (13vPnC / 13vPnC to 23vPS) calculated by back transforming the mean difference between vaccine groups on the logarithmic scale.||2.62|1.18|
72570972|NCT00546572|144670403|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 2-sided 95 % confidence interval for the geometric mean ratio (GMR) was \> 0.5 (2-fold criterion).|ratio of geometric mean titer|0.8|||||TWO_SIDED|95.0|0.62|1.13|||||Confidence intervals for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC / 13vPnC )- (23vPS)\].|Serotype 14: ratio of GMT (13vPnC / 13vPnC to 23vPS) calculated by back transforming the mean difference between vaccine groups on the logarithmic scale.||1.13|0.62|
72524461|NCT03934203|144579106|OTHER|The null hypothesis was 'The mean difference in the QTcF changes from baseline between 50 mg BI 409306 and placebo is greater than or equal to 10 milliseconds at least for one timepoint after dosing.' The one-sided tests were performed at the 5% level; due to the symmetry of the normal distribution 2-sided 90% confidence intervals for the differences of adjusted means per timepoint were used.|Difference of adjusted means|1.3|STANDARD_ERROR_OF_MEAN|0.7|||TWO_SIDED|90.0|0.2|2.4|||Mixed Models Analysis|Restricted maximum likelihood estimation and Kenward-Roger method to adjust standard errors and estimate denominator degrees of freedom.|Maximum difference of adjusted means was calculated as BI 409306 - placebo at 20 minutes after drug intake.|MMRM was fitted to observations for 50 mg BI 409306 and the 2 placebo periods. MMRM with covariates 'period baseline', 'participant baseline' (=arithmetic mean of respective period baselines), fixed categorical effects 'treatment', 'period', and 'time', interaction terms 'period baseline-by-time', 'participant baseline-by-time', 'treatment-by-time', and 'period-by-time', 'participant' (random effect), and time within period as repeated measures per participant (covariance matrix=Unstructured).||2.4|0.2|
72524462|NCT03934203|144579107|OTHER|The null hypothesis was 'The mean difference in the QTcF changes from baseline between 250 mg BI 409306 and placebo is greater than or equal to 10 milliseconds at least for one timepoint after dosing.' The one-sided tests were performed at the 5% level; due to the symmetry of the normal distribution 2-sided 90% confidence intervals for the differences of adjusted means per timepoint were used.|Difference of adjusted means|5.7|STANDARD_ERROR_OF_MEAN|0.8|||TWO_SIDED|90.0|4.4|7.1|||Mixed Models Analysis|Restricted maximum likelihood estimation and Kenward-Roger method to adjust standard errors and estimate denominator degrees of freedom.|Maximum difference of adjusted means was calculated as BI 409306 - placebo at 40 minutes after drug intake.|MMRM was fitted to observations for 250 mg BI 409306 and the 2 placebo periods. MMRM with covariates 'period baseline', 'participant baseline' (=arithmetic mean of respective period baselines), fixed categorical effects 'treatment', 'period', and 'time', interaction terms 'period baseline-by-time', 'participant baseline-by-time', 'treatment-by-time', and 'period-by-time', 'participant' (random effect), and time within period as repeated measures per participant (covariance matrix=Unstructured).||7.1|4.4|
72570973|NCT00546572|144670403|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 2-sided 95 % confidence interval for the geometric mean ratio (GMR) was \> 0.5 (2-fold criterion).|ratio of geometric mean titer|2.0|||||TWO_SIDED|95.0|1.53|2.69|||||Confidence intervals for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC / 13vPnC )- (23vPS)\].|Serotype 18C: ratio of GMT (13vPnC / 13vPnC to 23vPS) calculated by back transforming the mean difference between vaccine groups on the logarithmic scale.||2.69|1.53|
72625207|NCT01098747|144780079|SUPERIORITY_OR_OTHER||LS mean difference|-0.17||||0.134|TWO_SIDED|95.0|-0.4|0.05||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||4 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.05|-0.40|0.134
72524463|NCT03934203|144579108|OTHER|No formal hypotheses were tested.|Difference of adjusted means|12.1|STANDARD_ERROR_OF_MEAN|0.9|||TWO_SIDED|90.0|10.5|13.6|||Mixed Models Analysis|Restricted maximum likelihood estimation and Kenward-Roger method to adjust standard errors and estimate denominator degrees of freedom.|Maximum difference of adjusted means was calculated as moxifloxacin - placebo at 1 hour and 30 minutes after drug intake.|MMRM was fitted to the observations for moxifloxacin and the 2 placebo periods. MMRM with covariates 'period baseline', 'participant baseline' (=arithmetic mean of respective period baselines), fixed categorical effects 'treatment', 'period', and 'time', interaction terms 'period baseline-by-time', 'participant baseline-by-time', 'treatment-by-time', and 'period-by-time', 'participant' (random effect), and time within period as repeated measures per participant (covariance matrix=Unstructured).||13.6|10.5|
72524464|NCT03934203|144579109|OTHER|T-Test based on the results of the MMRM (fitted to the data for all timepoints). The null hypothesis was 'The mean difference in the QTcF changes from baseline between moxifloxacin and placebo is less than or equal to 5 milliseconds at 2 hours after drug administration.'|Difference of adjusted means|11.9|STANDARD_ERROR_OF_MEAN|0.9||0|TWO_SIDED|90.0|10.4|13.4||The corresponding alpha-level according to Hochberg's adjustment for mulitplicity was 0.0167.|Mixed Models Analysis|Restricted maximum likelihood estimation and Kenward-Roger method to adjust standard errors and estimate denominator degrees of freedom.|Difference of adjusted means was calculated as moxifloxacin - placebo.|MMRM was fitted to the observations for moxifloxacin and the 2 placebo periods. MMRM with covariates 'period baseline', 'participant baseline' (=arithmetic mean of respective period baselines), fixed categorical effects 'treatment', 'period', and 'time', interaction terms 'period baseline-by-time', 'participant baseline-by-time', 'treatment-by-time', and 'period-by-time', 'participant' (random effect), and time within period as repeated measures per participant (covariance matrix=Unstructured).||13.4|10.4|0.00000000
72524465|NCT03934203|144579110|OTHER|T-Test based on the results of the MMRM (fitted to the data for all timepoints). The null hypothesis was 'The mean difference in the QTcF changes from baseline between moxifloxacin and placebo is less than or equal to 5 milliseconds at 3 hours after drug administration.'|Difference of adjusted means|11.1|STANDARD_ERROR_OF_MEAN|1.0||3e-08|TWO_SIDED|90.0|9.3|12.8||The corresponding alpha-level according to Hochberg's adjustment for mulitplicity was 0.0250.|Mixed Models Analysis|Restricted maximum likelihood estimation and Kenward-Roger method to adjust standard errors and estimate denominator degrees of freedom.|Difference of adjusted means was calculated as moxifloxacin - placebo.|MMRM was fitted to the observations for moxifloxacin and the 2 placebo periods. MMRM with covariates 'period baseline', 'participant baseline' (=arithmetic mean of respective period baselines), fixed categorical effects 'treatment', 'period', and 'time', interaction terms 'period baseline-by-time', 'participant baseline-by-time', 'treatment-by-time', and 'period-by-time', 'participant' (random effect), and time within period as repeated measures per participant (covariance matrix=Unstructured).||12.8|9.3|0.00000003
72625208|NCT01098747|144780079|SUPERIORITY_OR_OTHER||LS mean difference|1.31|||<|0.001|TWO_SIDED|95.0|1.0|1.63||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||5 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.63|1.00|<0.001
72406498|NCT02942017|144321622|SUPERIORITY||LS Mean Difference|0.15|STANDARD_ERROR_OF_MEAN|0.169||0.3721|TWO_SIDED|95.0|-0.18|0.49|||MMRM|||Somatic Symptoms General, Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.49|-0.18|0.3721
72406499|NCT02942017|144321622|SUPERIORITY||LS Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.141||0.5513|TWO_SIDED|95.0|-0.36|0.2|||MMRM|||Somatic Symptoms General, Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.20|-0.36|0.5513
72406500|NCT02942017|144321622|SUPERIORITY||LS Mean Difference|0.12|STANDARD_ERROR_OF_MEAN|0.067||0.0748|TWO_SIDED|95.0|-0.01|0.26|||MMRM|||Genital Symptoms, Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.26|-0.01|0.0748
72406501|NCT02942017|144321622|SUPERIORITY||LS Mean Difference|0.08|STANDARD_ERROR_OF_MEAN|0.087||0.3545|TWO_SIDED|95.0|-0.09|0.25|||MMRM|||Genital Symptoms, Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.25|-0.09|0.3545
72406502|NCT02942017|144321622|SUPERIORITY||LS Mean Difference|0.04|STANDARD_ERROR_OF_MEAN|0.094||0.6531|TWO_SIDED|95.0|-0.14|0.23|||MMRM|||Genital Symptoms, Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.23|-0.14|0.6531
72524466|NCT03934203|144579111|OTHER|T-Test based on the results of the MMRM (fitted to the data for all timepoints). The null hypothesis was 'The mean difference in the QTcF changes from baseline between moxifloxacin and placebo is less than or equal to 5 milliseconds at 4 hours after drug administration.'|Difference of adjusted means|10.7|STANDARD_ERROR_OF_MEAN|1.1||2e-07|TWO_SIDED|90.0|8.9|12.4||The corresponding alpha-level according to Hochberg's adjustment for mulitplicity was 0.050.|Mixed Models Analysis|Restricted maximum likelihood estimation and Kenward-Roger method to adjust standard errors and estimate denominator degrees of freedom.|Difference of adjusted means was calculated as moxifloxacin - placebo.|MMRM was fitted to the observations for moxifloxacin and the 2 placebo periods. MMRM with covariates 'period baseline', 'participant baseline' (=arithmetic mean of respective period baselines), fixed categorical effects 'treatment', 'period', and 'time', interaction terms 'period baseline-by-time', 'participant baseline-by-time', 'treatment-by-time', and 'period-by-time', 'participant' (random effect), and time within period as repeated measures per participant (covariance matrix=Unstructured).||12.4|8.9|0.00000020
72542564|NCT01120600|144614968|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|5.59|||<|0.001|TWO_SIDED|95.0|4.48|6.7|||cLDA|||A constrained full likelihood longitudinal data analysis (cLDA) method was used for this statistical analysis. The cLDA model included the baseline measurement and all post-baseline percent changes from baseline in the response vector, with fixed effects for treatment, time, geographic region, machine type and treatment-by-time interaction, geographic region-by-time interaction, and machine type-by-time interaction.||6.7|4.48|< 0.001
72625209|NCT01098747|144780079|SUPERIORITY_OR_OTHER||LS mean difference|-0.17||||0.135|TWO_SIDED|95.0|-0.4|0.05||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||5 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.05|-0.40|0.135
72625210|NCT01098747|144780079|SUPERIORITY_OR_OTHER||LS mean difference|1.17|||<|0.001|TWO_SIDED|95.0|0.84|1.5||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||6 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.50|0.84|<0.001
72625211|NCT01098747|144780079|SUPERIORITY_OR_OTHER||LS mean difference|-0.25||||0.036|TWO_SIDED|95.0|-0.49|-0.02||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||6 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||-0.02|-0.49|0.036
72406503|NCT02942017|144321622|SUPERIORITY||LS Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.115||0.752|TWO_SIDED|95.0|-0.26|0.19|||MMRM|||Genital Symptoms, Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.19|-0.26|0.7520
72542565|NCT01120600|144614969|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|2.02|||<|0.001|TWO_SIDED|95.0|1.27|2.77|||cLDA|||A cLDA method was used for this statistical analysis. The cLDA model included the baseline measurement and all post-baseline percent changes from baseline in the response vector, with fixed effects for treatment, time, geographic region, machine type and treatment-by-time interaction, geographic region-by-time interaction, and machine type-by-time interaction.||2.77|1.27|< 0.001
72406504|NCT02942017|144321622|SUPERIORITY||LS Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.123||0.8861|TWO_SIDED|95.0|-0.26|0.23|||MMRM|||Genital Symptoms, Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.23|-0.26|0.8861
72524467|NCT03934203|144579112|OTHER|No formal hypotheses were tested.|Difference of adjusted means|2.4|STANDARD_ERROR_OF_MEAN|0.6|||TWO_SIDED|90.0|1.4|3.3|||Mixed Models Analysis|Restricted maximum likelihood estimation and Kenward-Roger method to adjust standard errors and estimate denominator degrees of freedom.|Maximum difference of adjusted means was calculated as BI 409306 - placebo at 20 minutes after drug intake.|MMRM was fitted to observations for 50 mg BI 409306 and the 2 placebo periods. MMRM with covariates 'period baseline', 'participant baseline' (=arithmetic mean of respective period baselines), fixed categorical effects 'treatment', 'period', and 'time', interaction terms 'period baseline-by-time', 'participant baseline-by-time', 'treatment-by-time', and 'period-by-time', 'participant' (random effect), and time within period as repeated measures per participant (covariance matrix=Unstructured).||3.3|1.4|
72524468|NCT03934203|144579113|OTHER|No formal hypotheses were tested.|Difference of adjusted means|11.7|STANDARD_ERROR_OF_MEAN|0.7|||TWO_SIDED|90.0|10.6|12.8|||Mixed Models Analysis|Restricted maximum likelihood estimation and Kenward-Roger method to adjust standard errors and estimate denominator degrees of freedom.|Maximum difference of adjusted means was calculated as BI 409306 - placebo at 40 minutes after drug intake.|MMRM was fitted to observations for 250 mg BI 409306 and the 2 placebo periods. MMRM with covariates 'period baseline', 'participant baseline' (=arithmetic mean of respective period baselines), fixed categorical effects 'treatment', 'period', and 'time', interaction terms 'period baseline-by-time', 'participant baseline-by-time', 'treatment-by-time', and 'period-by-time', 'participant' (random effect), and time within period as repeated measures per participant (covariance matrix=Unstructured).||12.8|10.6|
72524469|NCT03934203|144579114|OTHER|No formal hypotheses were tested.|Difference of adjusted means|-1.2|STANDARD_ERROR_OF_MEAN|0.6|||TWO_SIDED|90.0|-2.3|-0.1|||Mixed Models Analysis|Restricted maximum likelihood estimation and Kenward-Roger method to adjust standard errors and estimate denominator degrees of freedom.|Minimum difference of adjusted means was calculated as BI 409306 - placebo at 24 hours after drug intake.|MMRM was fitted to observations for 50 mg BI 409306 and the 2 placebo periods. MMRM with covariates 'period baseline', 'participant baseline' (=arithmetic mean of respective period baselines), fixed categorical effects 'treatment', 'period', and 'time', interaction terms 'period baseline-by-time', 'participant baseline-by-time', 'treatment-by-time', and 'period-by-time', 'participant' (random effect), and time within period as repeated measures per participant (covariance matrix=Unstructured).||-0.1|-2.3|
72524470|NCT03934203|144579115|OTHER|No formal hypotheses were tested.|Difference of adjusted means|0.0|STANDARD_ERROR_OF_MEAN|0.8|||TWO_SIDED|90.0|-1.3|1.3|||Mixed Models Analysis|Restricted maximum likelihood estimation and Kenward-Roger method to adjust standard errors and estimate denominator degrees of freedom.|Minimum difference of adjusted means was calculated as BI 409306 - placebo at 12 hours after drug intake.|MMRM was fitted to observations for 250 mg BI 409306 and the 2 placebo periods. MMRM with covariates 'period baseline', 'participant baseline' (=arithmetic mean of respective period baselines), fixed categorical effects 'treatment', 'period', and 'time', interaction terms 'period baseline-by-time', 'participant baseline-by-time', 'treatment-by-time', and 'period-by-time', 'participant' (random effect), and time within period as repeated measures per participant (covariance matrix=Unstructured).||1.3|-1.3|
72524471|NCT00608842|144579117|SUPERIORITY_OR_OTHER||Difference to placebo|0.0|||||TWO_SIDED|95.0|-18.4|20.4||||||Complete Clearance||20.4|-18.4|
72524472|NCT00608842|144579117|SUPERIORITY_OR_OTHER||Difference to placebo|0.0|||||TWO_SIDED|95.0|-18.4|20.4||||||Complete Clearance||20.4|-18.4|
72524473|NCT00608842|144579117|SUPERIORITY_OR_OTHER||Difference to placebo|7.1|||||TWO_SIDED|95.0|-12.2|31.5||||||Complete Clearance||31.5|-12.2|
72524474|NCT00608842|144579117|SUPERIORITY_OR_OTHER||Difference to placebo|1.6|||||TWO_SIDED|95.0|-23.0|27.5||||||≥ 75% Cleared||27.5|-23.0|
72524475|NCT00608842|144579117|SUPERIORITY_OR_OTHER||Difference to placebo|-5.1|||||TWO_SIDED|95.0|-28.3|19.6||||||≥ 75% Cleared||19.6|-28.3|
72524476|NCT00608842|144579117|SUPERIORITY_OR_OTHER||Difference to placebo|2.5|||||TWO_SIDED|95.0|-22.3|29.5||||||≥ 75% Cleared||29.5|-22.3|
72570974|NCT00546572|144670403|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 2-sided 95 % confidence interval for the geometric mean ratio (GMR) was \> 0.5 (2-fold criterion).|ratio of geometric mean titer|1.7|||||TWO_SIDED|95.0|1.37|2.1|||||Confidence intervals for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC / 13vPnC )- (23vPS)\].|Serotype 19A: ratio of GMT (13vPnC / 13vPnC to 23vPS) calculated by back transforming the mean difference between vaccine groups on the logarithmic scale.||2.10|1.37|
72524477|NCT04445051|144579123|SUPERIORITY||Mean Difference (Final Values)|32.9||||0.01|TWO_SIDED|95.0|8.3|57.5||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)\*Gender (male and females)||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||57.5|8.3|0.010
72524478|NCT04445051|144579123|SUPERIORITY||Mean Difference (Final Values)|34.3||||0.007|TWO_SIDED|95.0|9.8|58.8||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)\*Gender (male and females)||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||58.8|9.8|0.007
72524479|NCT04445051|144579123|SUPERIORITY||Mean Difference (Final Values)|1.4||||0.908|TWO_SIDED|95.0|-23.1|25.9||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)\*Gender (male and females)||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||25.9|-23.1|0.908
72625212|NCT01098747|144780079|SUPERIORITY_OR_OTHER||LS mean difference|0.93|||<|0.001|TWO_SIDED|95.0|0.61|1.26||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||7 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.26|0.61|<0.001
72406505|NCT02942017|144321622|SUPERIORITY||LS Mean Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.127||0.328|TWO_SIDED|95.0|-0.38|0.13|||MMRM|||Genital Symptoms, Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.13|-0.38|0.3280
72406506|NCT02942017|144321622|SUPERIORITY||LS Mean Difference|-0.21|STANDARD_ERROR_OF_MEAN|0.128||0.1123|TWO_SIDED|95.0|-0.46|0.05|||MMRM|||Genital Symptoms, Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.05|-0.46|0.1123
72524480|NCT04445051|144579123|SUPERIORITY||Mean Difference (Final Values)|35.3||||0.006|TWO_SIDED|95.0|10.8|59.8||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)\*Gender (male and females)||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||59.8|10.8|0.006
72524481|NCT04445051|144579123|SUPERIORITY||Mean Difference (Final Values)|36.8||||0.005|TWO_SIDED|95.0|11.9|61.8||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)\*Gender (male and females)||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||61.8|11.9|0.005
72524482|NCT04445051|144579123|SUPERIORITY||Mean Difference (Final Values)|1.5||||0.899|TWO_SIDED|95.0|-23.3|26.5||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)\*Gender (male and females)||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||26.5|-23.3|0.899
72524483|NCT04445051|144579124|SUPERIORITY||Mean Difference (Final Values)|8.8||||0.665|TWO_SIDED|95.0|-31.9|49.6||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)\*Gender (male and females)||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||49.6|-31.9|0.665
72524484|NCT04445051|144579124|SUPERIORITY||Mean Difference (Final Values)|-18.1||||0.375|TWO_SIDED|95.0|-58.7|22.4||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)\*Gender (male and females)||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||22.4|-58.7|0.375
72524485|NCT04445051|144579124|SUPERIORITY||Mean Difference (Final Values)|-27.0||||0.188|TWO_SIDED|95.0|-67.6|13.6||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)\*Gender (male and females)||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||13.6|-67.6|0.188
72524486|NCT04445051|144579124|SUPERIORITY||Mean Difference (Final Values)|-18.6||||0.361|TWO_SIDED|95.0|-59.3|21.9||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)\*Gender (male and females)||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||21.9|-59.3|0.361
72524487|NCT04445051|144579124|SUPERIORITY||Mean Difference (Final Values)|-10.9||||0.6|TWO_SIDED|95.0|-52.3|30.5||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)\*Gender (male and females)||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||30.5|-52.3|0.600
72524488|NCT04445051|144579124|SUPERIORITY||Mean Difference (Final Values)|7.78||||0.707|TWO_SIDED|95.0|-33.5|49.0||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)\*Gender (male and females)||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||49.0|-33.5|0.707
72524489|NCT04445051|144579125|SUPERIORITY||Mean Difference (Final Values)|-0.22||||0.615|TWO_SIDED|95.0|-1.08|0.65||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)\*Gender (male and females)||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.65|-1.08|0.615
72524490|NCT04445051|144579125|SUPERIORITY||Mean Difference (Final Values)|-0.31||||0.48|TWO_SIDED|95.0|-1.17|0.56||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)\*Gender (male and females)||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.56|-1.17|0.480
72524491|NCT04445051|144579125|SUPERIORITY||Mean Difference (Final Values)|-0.09||||0.839|TWO_SIDED|95.0|-0.95|0.77||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)\*Gender (male and females)||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.77|-0.95|0.839
72524492|NCT04445051|144579125|SUPERIORITY||Mean Difference (Final Values)|-0.06||||0.894|TWO_SIDED|95.0|-0.92|0.8||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)\*Gender (male and females)||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.80|-0.92|0.894
72524493|NCT04445051|144579125|SUPERIORITY||Mean Difference (Final Values)|-0.58||||0.195|TWO_SIDED|95.0|-1.46|0.3||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)\*Gender (male and females)||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.30|-1.46|0.195
72625213|NCT01098747|144780079|SUPERIORITY_OR_OTHER||LS mean difference|-0.22||||0.064|TWO_SIDED|95.0|-0.46|0.01||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||7 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.01|-0.46|0.064
72524494|NCT04445051|144579125|SUPERIORITY||Mean Difference (Final Values)|-0.52||||0.242|TWO_SIDED|95.0|-1.4|0.36||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)\*Gender (male and females)||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.36|-1.40|0.242
72524495|NCT04445051|144579126|SUPERIORITY||Mean Difference (Final Values)|-0.23||||0.639|TWO_SIDED|95.0|-1.2|0.74||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)\*Gender (male and females)||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.74|-1.20|0.639
72524496|NCT04445051|144579126|SUPERIORITY||Mean Difference (Final Values)|-0.33||||0.492|TWO_SIDED|95.0|-1.3|0.63||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)\*Gender (male and females)||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.63|-1.30|0.492
72524497|NCT04445051|144579126|SUPERIORITY||Mean Difference (Final Values)|-0.11||||0.828|TWO_SIDED|95.0|-1.07|0.86||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)\*Gender (male and females)||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.86|-1.07|0.828
72524498|NCT04445051|144579126|SUPERIORITY||Mean Difference (Final Values)|0.16||||0.744|TWO_SIDED|95.0|-0.81|1.13||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)\*Gender (male and females)||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||1.13|-0.81|0.744
72524499|NCT04445051|144579126|SUPERIORITY||Mean Difference (Final Values)|-0.63||||0.208|TWO_SIDED|95.0|-1.62|0.36||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)\*Gender (male and females)||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.36|-1.62|0.208
72524500|NCT04445051|144579126|SUPERIORITY||Mean Difference (Final Values)|-0.79||||0.116|TWO_SIDED|95.0|-1.77|0.2||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)\*Gender (male and females)||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.20|-1.77|0.116
72524501|NCT04445051|144579127|SUPERIORITY||Mean Difference (Final Values)|0.11||||0.798|TWO_SIDED|95.0|-0.75|0.96||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)\*Gender (male and females)||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.96|-0.75|0.798
72524502|NCT04445051|144579127|SUPERIORITY||Mean Difference (Final Values)|-0.25||||0.556|TWO_SIDED|95.0|-1.1|0.6||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)\*Gender (male and females)||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.60|-1.10|0.556
72524503|NCT04445051|144579127|SUPERIORITY||Mean Difference (Final Values)|-0.36||||0.399|TWO_SIDED|95.0|-1.21|0.49||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)\*Gender (male and females)||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.49|-1.21|0.399
72524504|NCT04445051|144579127|SUPERIORITY||Mean Difference (Final Values)|0.55||||0.198|TWO_SIDED|95.0|-0.3|1.41||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)\*Gender (male and females)||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||1.41|-0.30|0.198
72524505|NCT04445051|144579127|SUPERIORITY||Mean Difference (Final Values)|-0.4||||0.365|TWO_SIDED|95.0|-1.27|0.48||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)\*Gender (male and females)||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.48|-1.27|0.365
72524506|NCT04445051|144579127|SUPERIORITY||Mean Difference (Final Values)|-0.95||||0.033|TWO_SIDED|95.0|-1.82|-0.08||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)\*Gender (male and females)||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||-0.08|-1.82|0.033
72524507|NCT04445051|144579128|SUPERIORITY||Mean Difference (Final Values)|0.07||||0.882|TWO_SIDED|95.0|-0.83|0.96||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)\*Gender (male and females)||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.96|-0.83|0.882
72524508|NCT04445051|144579128|SUPERIORITY||Mean Difference (Final Values)|-0.32||||0.478|TWO_SIDED|95.0|-1.21|0.57||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)\*Gender (male and females)||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.57|-1.21|0.478
72524509|NCT04445051|144579128|SUPERIORITY||Mean Difference (Final Values)|-0.38||||0.391|TWO_SIDED|95.0|-1.27|0.51||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)\*Gender (male and females)||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.51|-1.27|0.391
72524510|NCT04445051|144579128|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.657|TWO_SIDED|95.0|-0.69|1.09||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)\*Gender (male and females)||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||1.09|-0.69|0.657
72524511|NCT04445051|144579128|SUPERIORITY||Mean Difference (Final Values)|-0.71||||0.125|TWO_SIDED|95.0|-1.62|0.2||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)\*Gender (male and females)||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.20|-1.62|0.125
72524512|NCT04445051|144579128|SUPERIORITY||Mean Difference (Final Values)|-0.91||||0.051|TWO_SIDED|95.0|-1.81|0.0||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)\*Gender (male and females)||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.00|-1.81|0.051
72524513|NCT04445051|144579129|SUPERIORITY||Mean Difference (Final Values)|0.07||||0.877|TWO_SIDED|95.0|-0.83|0.97||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)\*Gender (male and females)||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.97|-0.83|0.877
72524514|NCT04445051|144579129|SUPERIORITY||Mean Difference (Final Values)|-0.42||||0.351|TWO_SIDED|95.0|-1.31|0.47||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)\*Gender (male and females)||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.47|-1.31|0.351
72570975|NCT00546572|144670403|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 2-sided 95 % confidence interval for the geometric mean ratio (GMR) was \> 0.5 (2-fold criterion).|ratio of geometric mean titer|1.5|||||TWO_SIDED|95.0|1.09|1.93|||||Confidence intervals for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC / 13vPnC )- (23vPS)\].|Serotype 19F: ratio of GMT (13vPnC / 13vPnC to 23vPS) calculated by back transforming the mean difference between vaccine groups on the logarithmic scale.||1.93|1.09|
72570976|NCT00546572|144670403|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 2-sided 95 % confidence interval for the geometric mean ratio (GMR) was \> 0.5 (2-fold criterion).|ratio of geometric mean titer|7.3|||||TWO_SIDED|95.0|5.36|9.82|||||Confidence intervals for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC / 13vPnC )- (23vPS)\].|Serotype 23F: ratio of GMT (13vPnC / 13vPnC to 23vPS) calculated by back transforming the mean difference between vaccine groups on the logarithmic scale.||9.82|5.36|
72570977|NCT00546572|144670404|SUPERIORITY_OR_OTHER||ratio of geometric mean titer|12.1|||||TWO_SIDED|95.0|8.92|16.44|||||Confidence intervals for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC / 13vPnC )- (23vPS)\].|"Serotype 6A: ratio of GMT (13vPnC / 13vPnC to 23vPS) calculated by back transforming the mean difference between vaccine groups on the logarithmic scale.~Statistical significance was demonstrated if the lower limit of the 2-sided 95% confidence interval for the geometric mean ratio was \>2."||16.44|8.92|
72625214|NCT01098747|144780079|SUPERIORITY_OR_OTHER||LS mean difference|0.85|||<|0.001|TWO_SIDED|95.0|0.52|1.18||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||8 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.18|0.52|<0.001
72524515|NCT04445051|144579129|SUPERIORITY||Mean Difference (Final Values)|-0.49||||0.278|TWO_SIDED|95.0|-1.38|0.4||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)\*Gender (male and females)||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.40|-1.38|0.278
72570978|NCT00546572|144670405|SUPERIORITY_OR_OTHER||difference in proportions|-11.4|||<|0.001|TWO_SIDED|95.0|-17.3|-5.6|||Chan & Zhang||Exact 2-sided confidence interval and corresponding p-value (based on Chan \& Zhang) for the difference in proportions, \[13vPnC\] - \[23vPS\], expressed as a percentage.|Redness: any; difference in proportions, \[13vPnC\] - \[23vPS\], expressed as a percentage.||-5.6|-17.3|<0.001
72570979|NCT00546572|144670405|SUPERIORITY_OR_OTHER||difference in proportions|-4.0||||0.129|TWO_SIDED|95.0|-9.1|1.1|||Chan & Zhang||Exact 2-sided confidence interval and corresponding p-value (based on Chan \& Zhang) for the difference in proportions, \[13vPnC\] - \[23vPS\], expressed as a percentage.|Redness: mild; difference in proportions, \[13vPnC\] - \[23vPS\], expressed as a percentage.||1.1|-9.1|0.129
72570980|NCT00546572|144670405|SUPERIORITY_OR_OTHER||difference in proportions|-6.8||||0.002|TWO_SIDED|95.0|-11.3|-2.3|||Chan & Zhang||Exact 2-sided confidence interval and corresponding p-value (based on Chan \& Zhang) for the difference in proportions, \[13vPnC\] - \[23vPS\], expressed as a percentage.|Redness: moderate; difference in proportions, \[13vPnC\] - \[23vPS\], expressed as a percentage.||-2.3|-11.3|0.002
72406507|NCT02942017|144321622|SUPERIORITY||LS Mean Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.116||0.2541|TWO_SIDED|95.0|-0.36|0.1|||MMRM|||Genital Symptoms, Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.10|-0.36|0.2541
72406508|NCT02942017|144321622|SUPERIORITY||LS Mean Difference|-0.37|STANDARD_ERROR_OF_MEAN|0.143||0.011|TWO_SIDED|95.0|-0.66|-0.09|||MMRM|||Genital Symptoms, Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.09|-0.66|0.0110
72406509|NCT02942017|144321622|SUPERIORITY||LS Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.158||0.772|TWO_SIDED|95.0|-0.36|0.27|||MMRM|||Genital Symptoms, Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.27|-0.36|0.7720
72406510|NCT02942017|144321622|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.21||0.6311|TWO_SIDED|95.0|-0.52|0.32|||MMRM|||Genital Symptoms, Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.32|-0.52|0.6311
72406511|NCT02942017|144321622|SUPERIORITY||LS Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.207||0.6877|TWO_SIDED|95.0|-0.5|0.33|||MMRM|||Genital Symptoms, Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.33|-0.50|0.6877
72406512|NCT02942017|144321622|SUPERIORITY||LS Mean Difference|0.22|STANDARD_ERROR_OF_MEAN|0.186||0.2465|TWO_SIDED|95.0|-0.15|0.58|||MMRM|||Genital Symptoms, Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.58|-0.15|0.2465
72406513|NCT02942017|144321622|SUPERIORITY||LS Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.101||0.1279|TWO_SIDED|95.0|-0.36|0.05|||MMRM|||Hypochondriasis, Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.05|-0.36|0.1279
72406514|NCT02942017|144321622|SUPERIORITY||LS Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.093||0.3946|TWO_SIDED|95.0|-0.26|0.1|||MMRM|||Hypochondriasis, Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.10|-0.26|0.3946
72524516|NCT04445051|144579129|SUPERIORITY||Mean Difference (Final Values)|0.17||||0.711|TWO_SIDED|95.0|-0.73|1.06||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)\*Gender (male and females)||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||1.06|-0.73|0.711
72524517|NCT04445051|144579129|SUPERIORITY||Mean Difference (Final Values)|-1.06||||0.024|TWO_SIDED|95.0|-1.97|-0.15||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)\*Gender (male and females)||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||-0.15|-1.97|0.024
72524518|NCT04445051|144579129|SUPERIORITY||Mean Difference (Final Values)|-1.23||||0.009|TWO_SIDED|95.0|-2.14|-0.31||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)\*Gender (male and females)||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||-0.31|-2.14|0.009
72570981|NCT00546572|144670405|SUPERIORITY_OR_OTHER||difference in proportions|-3.2||||0.028|TWO_SIDED|95.0|-6.3|-0.3|||Chan & Zhang||Exact 2-sided confidence interval and corresponding p-value (based on Chan \& Zhang) for the difference in proportions, \[13vPnC\] - \[23vPS\], expressed as a percentage.|Redness: severe; difference in proportions, \[13vPnC\] - \[23vPS\], expressed as a percentage.||-0.3|-6.3|0.028
72625215|NCT01098747|144780079|SUPERIORITY_OR_OTHER||LS mean difference|-0.22||||0.074|TWO_SIDED|95.0|-0.46|0.02||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||8 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.02|-0.46|0.074
72625216|NCT01098747|144780080|SUPERIORITY_OR_OTHER||LS mean difference|0.65||||0.001|TWO_SIDED|95.0|0.26|1.04||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||0.25 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.04|0.26|0.001
72625217|NCT01098747|144780080|SUPERIORITY_OR_OTHER||LS mean difference|0.46||||0.001|TWO_SIDED|95.0|0.18|0.75||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||0.25 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.75|0.18|0.001
72625218|NCT01098747|144780080|SUPERIORITY_OR_OTHER||LS mean difference|2.41|||<|0.001|TWO_SIDED|95.0|1.82|3.01||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||0.5 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||3.01|1.82|<0.001
72625219|NCT01098747|144780080|SUPERIORITY_OR_OTHER||LS mean difference|0.91|||<|0.001|TWO_SIDED|95.0|0.48|1.34||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||0.5 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.34|0.48|<0.001
72524519|NCT00901394|144579148|SUPERIORITY||||||<|0.05|||||||Mixed Models Analysis|||For baseline comparisons among the three groups, one-way ANOVA was used for normally distributed variables and χ2 goodness-of-fit for categorical variables. To model the effects of B-vitamin treatment on nitrous-oxide-induced total homocysteine increase at the three different timepoints within individual patients and between the three groups, a linear mixed model with was used and we included a group × time interaction in the model.||||<0.05
72524520|NCT01388491|144579152|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-11.8||||0.5892|TWO_SIDED|95.0|-54.75|31.17||The p-value, least squares mean difference, and 95% CI for the treatment group comparison are based on a repeated measures ANCOVA with baseline, treatment, visit, and treatment-by-visit interaction as fixed factors, and subject as a random effect.|ANCOVA|Least Squares mean difference: Treatment I - Treatment II||||31.17|-54.75|0.5892
72524521|NCT01388491|144579153|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|3.0||||0.839|TWO_SIDED|95.0|-25.96|31.94||The p-value, least squares mean difference, and 95% CI for the treatment group comparison are based on a repeated measures ANCOVA with baseline, treatment, visit, and treatment-by-visit interaction as fixed factors, and subject as a random effect.|ANCOVA|Least Squares mean difference: Treatment I - Treatment II||||31.94|-25.96|0.839
72524522|NCT01388491|144579154|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-4.8||||0.0021|TWO_SIDED|95.0|-7.87|-1.77||The p-value, least squares mean difference, and 95% CI for the treatment group comparison are based on a repeated measures ANCOVA with baseline, treatment, visit, and treatment-by-visit interaction as fixed factors, and subject as a random effect.|ANCOVA|Least Squares mean difference: Treatment I - Treatment II||||-1.77|-7.87|0.0021
72524523|NCT01388491|144579155|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|3.2||||0.2312|TWO_SIDED|95.0|-2.08|8.58||The p-value, least squares mean difference, and 95% CI for the treatment group comparison are based on a repeated measures ANCOVA with baseline, treatment, visit, and treatment-by-visit interaction as fixed factors, and subject as a random effect.|ANCOVA|Least Squares mean difference: Treatment I - Treatment II||||8.58|-2.08|0.2312
72524524|NCT01388491|144579156|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|1.6||||0.344|TWO_SIDED|95.0|-1.7|4.85||The p-value, least squares mean difference, and 95% CI for the treatment group comparison are based on a repeated measures ANCOVA with baseline, treatment, visit, and treatment-by-visit interaction as fixed factors, and subject as a random effect.|ANCOVA|Least Squares mean difference: Treatment I - Treatment II||||4.85|-1.70|0.3440
72524525|NCT01388491|144579157|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|0.3||||0.2522|TWO_SIDED|95.0|-0.24|0.92||The p-value, least squares mean difference, and 95% CI for the treatment group comparison are based on a repeated measures ANCOVA with baseline, treatment, visit, and treatment-by-visit interaction as fixed factors, and subject as a random effect.|ANCOVA|Least Squares mean difference: Treatment I - Treatment II||||0.92|-0.24|0.2522
72524526|NCT01388491|144579158|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|2.9||||0.0143|TWO_SIDED|95.0|0.58|5.13||The p-value, least squares mean difference, and 95% CI for the treatment group comparison are based on a repeated measures ANCOVA with baseline, treatment, visit, and treatment-by-visit interaction as fixed factors, and subject as a random effect.|ANCOVA|Least Squares mean difference: Treatment I - Treatment II||||5.13|0.58|0.0143
72625220|NCT01098747|144780080|SUPERIORITY_OR_OTHER||LS mean difference|3.68|||<|0.001|TWO_SIDED|95.0|3.03|4.33||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1 hour: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||4.33|3.03|<0.001
72524527|NCT01388491|144579159|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|0.5||||0.8507|TWO_SIDED|95.0|-4.87|5.91||The p-value, least squares mean difference, and 95% CI for the treatment group comparison are based on a repeated measures ANCOVA with baseline, treatment, visit, and treatment-by-visit interaction as fixed factors, and subject as a random effect.|ANCOVA|Least Squares mean difference: Treatment I - Treatment II||||5.91|-4.87|0.8507
72524528|NCT01388491|144579160|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|0.1||||0.0459|TWO_SIDED|95.0|0.0|0.14||The p-value, least squares mean difference, and 95% CI for the treatment group comparison are based on a repeated measures ANCOVA with baseline, treatment, visit, and treatment-by-visit interaction as fixed factors, and subject as a random effect.|ANCOVA|Least Squares mean difference: Treatment I - Treatment II||||0.14|0.00|0.0459
72524529|NCT01388491|144579161|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|0.1||||0.0318|TWO_SIDED|95.0|0.01|0.26||The p-value, least squares mean difference, and 95% CI for the treatment group comparison are based on a repeated measures ANCOVA with baseline, treatment, visit, and treatment-by-visit interaction as fixed factors, and subject as a random effect.|ANCOVA|Least Squares mean difference: Treatment I - Treatment II||||0.26|0.01|0.0318
72524530|NCT01388491|144579162|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|361.6||||0.1148|TWO_SIDED|95.0|-88.45|811.61||The p-value, least squares mean difference, and 95% CI for the treatment group comparison are based on a repeated measures ANCOVA with baseline, treatment, visit, and treatment-by-visit interaction as fixed factors, and subject as a random effect.|ANCOVA|Least Squares mean difference: Treatment I - Treatment II||||811.61|-88.45|0.1148
72524531|NCT01388491|144579163|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|8.2||||0.7136|TWO_SIDED|95.0|-35.92|52.39||The p-value, least squares mean difference, and 95% CI for the treatment group comparison are based on a repeated measures ANCOVA with baseline, treatment, visit, and treatment-by-visit interaction as fixed factors, and subject as a random effect.|ANCOVA|Least Squares mean difference: Treatment I - Treatment II||||52.39|-35.92|0.7136
72524532|NCT01388491|144579164|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.1||||0.3903|TWO_SIDED|95.0|-0.29|0.11||The p-value, least squares mean difference, and 95% CI for the treatment group comparison are based on a repeated measures ANCOVA with baseline, treatment, visit, and treatment-by-visit interaction as fixed factors, and subject as a random effect.|ANCOVA|Least Squares mean difference: Treatment I - Treatment II||||0.11|-0.29|0.3903
72524533|NCT01388491|144579165|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|14.3||||0.1731|TWO_SIDED|95.0|-6.29|34.8||The p-value, least squares mean difference, and 95% CI for the treatment group comparison are based on a repeated measures ANCOVA with baseline, treatment, visit, and treatment-by-visit interaction as fixed factors, and subject as a random effect.|ANCOVA|Least Squares mean difference: Treatment I - Treatment II||||34.80|-6.29|0.1731
72524534|NCT00864123|144579166|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.0|STANDARD_DEVIATION|6.3|<|0.05||95.0|||||ANOVA|||Data were analyzed with separate 2 (site: Florida, MGH) by 2 (condition: CBT+DCS, CBT+Placebo) by 3 (time: pre-treatment, mid-treatment, post-treatment; Dependent variables: CY-BOCS Total Score) fixed-effects linear regression with time as the repeated measure. Cohen's d was used to examine the magnitude of treatment effects.||||<0.05
72524535|NCT00864123|144579167|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.0|STANDARD_DEVIATION|1.1|<|0.05|TWO_SIDED|95.0|||||ANOVA|||Data were analyzed with separate 2 (site: Florida, MGH) by 2 (condition: CBT+DCS, CBT+Placebo) by 3 (time: pre-treatment, mid-treatment, post-treatment; Dependent variables: CGI-Severity) fixed-effects linear regression with time as the repeated measure. Cohen's d was used to examine the magnitude of treatment effects.||||<0.05
72524536|NCT03227224|144579192|SUPERIORITY||Difference of Least Square Means|0.9||||0.724|TWO_SIDED|90.0|-3.12|4.82|||Mixed model for repeated measures (MMRM)|||||4.82|-3.12|0.724
72570982|NCT00546572|144670405|SUPERIORITY_OR_OTHER||difference in proportions|-12.7|||<|0.001|TWO_SIDED|95.0|-18.5|-7.0|||Chan & Zhang||Exact 2-sided confidence interval and corresponding p-value (based on Chan \& Zhang) for the difference in proportions, \[13vPnC\] - \[23vPS\], expressed as a percentage.|Swelling: any; difference in proportions, \[13vPnC\] - \[23vPS\], expressed as a percentage.||-7.0|-18.5|<0.001
72570983|NCT00546572|144670405|SUPERIORITY_OR_OTHER||difference in proportions|-5.1||||0.048|TWO_SIDED|95.0|-10.2|-0.1|||Chan & Zhang||Exact 2-sided confidence interval and corresponding p-value (based on Chan \& Zhang) for the difference in proportions, \[13vPnC\] - \[23vPS\], expressed as a percentage.|Swelling: mild; difference in proportions, \[13vPnC\] - \[23vPS\], expressed as a percentage.||-0.1|-10.2|0.048
72369334|NCT00611026|144248572|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.3|STANDARD_ERROR_OF_MEAN|0.9||0.0003|TWO_SIDED|95.0|1.5|5.2|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.|Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.|Treatment Difference Fesoterodine vs Tolterodine ER: HRQL scale score total.||5.2|1.5|0.0003
72369335|NCT00611026|144248572|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.6|STANDARD_ERROR_OF_MEAN|1.3|<|0.0001|TWO_SIDED|95.0|4.0|9.2|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.||Treatment Difference Fesoterodine vs placebo: HRQL concern domain.||9.2|4.0|<0.0001
72369336|NCT00611026|144248572|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.3|STANDARD_ERROR_OF_MEAN|1.3||0.0795|TWO_SIDED|95.0|-0.3|4.9|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.|Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.|Treatment Difference Placebo vs Tolterodine ER: HRQL concern domain.||4.9|-0.3|0.0795
72369337|NCT00611026|144248572|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.2|STANDARD_ERROR_OF_MEAN|1.1|<|0.0001|TWO_SIDED|95.0|2.1|6.3|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.|Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.|Treatment Difference Fesoterodine vs Tolterodine ER: HRQL concern domain.||6.3|2.1|<0.0001
72369338|NCT00611026|144248572|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.0|STANDARD_ERROR_OF_MEAN|1.4|<|0.0001|TWO_SIDED|95.0|4.3|9.6|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.|Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.|Treatment Difference Fesoterodine vs placebo: HRQL coping domain.||9.6|4.3|<0.0001
72524537|NCT03227224|144579192|SUPERIORITY||Difference of Least Square Means|-3.1||||0.083|TWO_SIDED|90.0|-6.13|-0.16|||MMRM|||||-0.16|-6.13|0.083
72524538|NCT03227224|144579192|SUPERIORITY||Difference of Least Square Means|-1.5||||0.424|TWO_SIDED|90.0|-4.7|1.63|||MMRM|||||1.63|-4.70|0.424
72524539|NCT04195750|144579234|SUPERIORITY||Hazard Ratio (HR)|0.74||||0.00031|TWO_SIDED|95.0|0.63|0.88|||Log Rank|One-sided p-value based on log-rank test stratified by IMDC Risk Category and Number of prior VEGF/VEGF-Receptor Targeted Therapies for RCC.|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by IMDC Risk Category and Number of prior VEGF/VEGF-Receptor Targeted Therapies for RCC.|||0.88|0.63|0.00031
72524540|NCT04195750|144579235|SUPERIORITY||Hazard Ratio (HR)|0.92||||0.17644|TWO_SIDED|95.0|0.77|1.1|||Log Rank|One-sided p-value based on log-rank test stratified by IMDC Risk Category and Number of prior VEGF/VEGF-Receptor Targeted Therapies for RCC.|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by IMDC Risk Category and Number of prior VEGF/VEGF-Receptor Targeted Therapies for RCC.|||1.10|0.77|0.17644
72524541|NCT04195750|144579236|SUPERIORITY|P-value, difference in percentage and associated 95% CI were calculated using Miettinen \& Nurminen method stratified by IMDC Risk Category and Number of prior VEGF/VEGF-Receptor Targeted Therapies for RCC.|Difference in Percentage|18.4|||<|1e-05|TWO_SIDED|95.0|14.0|23.2||One-sided p-value for testing. H0: difference in % = 0 versus H1: difference in % \> 0.|Miettinen & Nurminen||Belzutifan minus Everolimus|||23.2|14.0|<0.00001
72524542|NCT04195750|144579240|OTHER||Hazard Ratio (HR)|0.75||||0.0185|TWO_SIDED|95.0|0.58|0.96|||Log Rank|Two-sided p-value based on log-rank test stratified by IMDC Risk Category and Number of prior VEGF/VEGF-Receptor Targeted Therapies for RCC.|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by IMDC Risk Category and Number of prior VEGF/VEGF-Receptor Targeted Therapies for RCC.|||0.96|0.58|0.0185
72524543|NCT04195750|144579241|OTHER||Hazard Ratio (HR)|0.93||||0.5533|TWO_SIDED|95.0|0.72|1.2|||Log Rank|Two-sided p-value based on log-rank test stratified by IMDC Risk Category and Number of prior VEGF/VEGF-Receptor Targeted Therapies for RCC.|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by IMDC Risk Category and Number of prior VEGF/VEGF-Receptor Targeted Therapies for RCC.|||1.20|0.72|0.5533
72524544|NCT04195750|144579242|OTHER||Hazard Ratio (HR)|0.53|||<|0.0001|TWO_SIDED|95.0|0.41|0.69|||Log Rank|Two-sided p-value based on log-rank test stratified by IMDC Risk Category and Number of prior VEGF/VEGF-Receptor Targeted Therapies for RCC.|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by IMDC Risk Category and Number of prior VEGF/VEGF-Receptor Targeted Therapies for RCC.|||0.69|0.41|<0.0001
72524545|NCT04195750|144579243|OTHER||Difference in Least Squares (LS) Means|6.38|||<|0.0001|TWO_SIDED|95.0|3.21|9.55|||t-test, 2 sided||Based on a cLDA model with scores as the response variable with covariates for treatment by time interaction, stratification factors (IMDC Risk Category, and Number of Prior VEGF/VEGF-Receptor Targeted Therapies for RCC) as covariates.|||9.55|3.21|<0.0001
72524546|NCT04195750|144579244|OTHER||Difference in LS Means|2.47||||0.1134|TWO_SIDED|95.0|-0.59|5.54|||t-test, 2 sided||Based on a cLDA model with scores as the response variable with covariates for treatment by time interaction, stratification factors (IMDC Risk Category, and Number of Prior VEGF/VEGF-Receptor Targeted Therapies for RCC) as covariates.|||5.54|-0.59|0.1134
72524547|NCT04195750|144579245|OTHER||Difference in LS Means|1.45||||0.0002|TWO_SIDED|95.0|0.7|2.19|||t-test, 2 sided||Based on a cLDA model with the PRO scores as the response variable with covariates for treatment by time interaction, stratification factors (IMDC Risk Category, and Number of Prior VEGF/VEGF-Receptor Targeted Therapies for RCC) as covariates.|||2.19|0.70|0.0002
72369339|NCT00611026|144248572|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.1|STANDARD_ERROR_OF_MEAN|1.3||0.0229|TWO_SIDED|95.0|0.4|5.7|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.|Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.|Treatment Difference Tolterodine ER vs placebo: HRQL coping domain.||5.7|0.4|0.0229
72369340|NCT00611026|144248572|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.9|STANDARD_ERROR_OF_MEAN|1.1||0.0004|TWO_SIDED|95.0|1.7|6.0|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.|Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.|Treatment Difference Fesoterodine vs Tolterodine ER: HRQL coping domain.||6.0|1.7|0.0004
72369341|NCT00611026|144248572|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.5|STANDARD_ERROR_OF_MEAN|1.2||0.0003|TWO_SIDED|95.0|2.0|6.9|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.|Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.|Treatment Difference Fesoterodine vs placebo: HRQL sleep domain.||6.9|2.0|0.0003
72369342|NCT00611026|144248572|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.1|STANDARD_ERROR_OF_MEAN|1.2||0.0923|TWO_SIDED|95.0|-0.3|4.5|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.|Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.|Treatment Difference Tolterodine ER vs placebo: HRQL sleep domain.||4.5|-0.3|0.0923
72369343|NCT00611026|144248572|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.4|STANDARD_ERROR_OF_MEAN|1.0||0.018|TWO_SIDED|95.0|0.4|4.4|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.|Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.|Treatment Difference Tolterodine ER vs Fesoterodine: HRQL sleep domain.||4.4|0.4|0.0180
72369344|NCT00611026|144248572|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.2|STANDARD_ERROR_OF_MEAN|1.0||0.0011|TWO_SIDED|95.0|1.3|5.1|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.|Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.|Treatment Difference Fesoterodine vs placebo: HRQL social interaction domain.||5.1|1.3|0.0011
72524548|NCT04195750|144579246|OTHER||Difference in LS Means|3.72||||0.0051|TWO_SIDED|95.0|1.12|6.31|||t-test, 2 sided||Based on a cLDA model with the PRO scores as the response variable with covariates for treatment by time interaction, stratification factors (IMDC Risk Category, and Number of Prior VEGF/VEGF-Receptor Targeted Therapies for RCC) as covariates.|||6.31|1.12|0.0051
72524549|NCT03782376|144579286|SUPERIORITY||Difference in percentage|11.5||||0.089|TWO_SIDED|95.0|-1.5|24.5||Threshold for significance was 0.05 level.|Cochran-Mantel Haenszel-chi-square test|||The fixed sequence testing method was used. CMH chi-square test (2-sided) stratified by baseline CDAI score (\<= 300 or \> 300), and prior biologic failure status at baseline (yes or no).||24.5|-1.5|0.089
72524550|NCT03782376|144579287|SUPERIORITY||Difference in percentage|5.9||||0.338|TWO_SIDED|95.0|-6.0|17.8|||CMH chi-square test (2-sided)|||The fixed sequence testing method was used. CMH chi-square test (2-sided) stratified by baseline CDAI score (\<= 300 or \> 300), and prior biologic failure status at baseline (yes or no).||17.8|-6.0|0.338
72524551|NCT03782376|144579288|SUPERIORITY||Difference in percentage|7.1||||0.3|TWO_SIDED|95.0|-6.0|20.2|||CMH chi-square test (2-sided)|||The fixed sequence testing method was used. CMH chi-square test (2-sided) stratified by baseline CDAI score (\<= 300 or \> 300), and prior biologic failure status at baseline (yes or no).||20.2|-6.0|0.300
72524552|NCT03782376|144579289|SUPERIORITY||Difference in percentage|6.4||||0.314|TWO_SIDED|95.0|-5.8|18.6|||CMH chi-square test (2-sided)|||The fixed sequence testing method was used. CMH chi-square test (2-sided) stratified by baseline CDAI score (\<= 300 or \> 300), and prior biologic failure status at baseline (yes or no).||18.6|-5.8|0.314
72524553|NCT03782376|144579290|SUPERIORITY||Difference in percentage|18.5||||0.004|TWO_SIDED|95.0|6.8|30.2|||CMH chi-square test (2-sided)|||The fixed sequence testing method was used. CMH chi-square test (2-sided) stratified by baseline CDAI score (\<= 300 or \> 300), and prior biologic failure status at baseline (yes or no).||30.2|6.8|0.004
72524554|NCT03559192|144579304|SUPERIORITY||Least Squares Mean Difference|-2.1|STANDARD_ERROR_OF_MEAN|1.25|=|0.0443|ONE_SIDED|80.0||-1.09|||Mixed Models Analysis|||||-1.09||= 0.0443
72524555|NCT03559192|144579305|SUPERIORITY||Least Squares Mean Difference|-3.1|STANDARD_ERROR_OF_MEAN|1.05||0.0017|ONE_SIDED|80.0||-2.21|||Mixed Models Analysis|||||-2.21||0.0017
72524556|NCT03559192|144579307|SUPERIORITY||Least Squares Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.87|=|0.4188|ONE_SIDED|80.0||0.41|||Mixed Models Analysis|||||0.41||= 0.4188
72524557|NCT03559192|144579308|SUPERIORITY||Least Squares Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.73||0.2503|ONE_SIDED|80.0||0.1|||Mixed Models Analysis|||||0.10||0.2503
72524558|NCT03517722|144579323|SUPERIORITY||Odds Ratio (OR)|0.6||||0.042|TWO_SIDED|95.0|0.4|1.0|||Regression, Logistic|||||1.0|0.4|0.042
72570984|NCT00546572|144670405|SUPERIORITY_OR_OTHER||difference in proportions|-9.6|||<|0.001|TWO_SIDED|95.0|-14.2|-5.1|||Chan & Zhang||Exact 2-sided confidence interval and corresponding p-value (based on Chan \& Zhang) for the difference in proportions, \[13vPnC\] - \[23vPS\], expressed as a percentage.|Swelling: moderate; difference in proportions, \[13vPnC\] - \[23vPS\], expressed as a percentage.||-5.1|-14.2|<0.001
72570985|NCT00546572|144670405|SUPERIORITY_OR_OTHER||difference in proportions|-4.8|||<|0.001|TWO_SIDED|95.0|-7.9|-2.7|||Chan & Zhang||Exact 2-sided confidence interval and corresponding p-value (based on Chan \& Zhang) for the difference in proportions, \[13vPnC\] - \[23vPS\], expressed as a percentage.|Swelling: severe; difference in proportions, \[13vPnC\] - \[23vPS\], expressed as a percentage.||-2.7|-7.9|<0.001
72524559|NCT02422186|144579330|SUPERIORITY||Difference of Least Square (LS) Means|-3.6|||=|0.059|TWO_SIDED|95.0|-7.2|0.07|||Mixed Model for Repeated Measures|||||0.07|-7.20|=0.059
72524560|NCT02422186|144579331|OTHER||Least Square (LS) Mean Difference|-3.6|||=|0.052|TWO_SIDED|95.0|-7.16|-0.03|||ANCOVA|||||-0.03|-7.16|=0.052
72524561|NCT05849441|144579340|SUPERIORITY|||||||0.04||||||This is for the subscale: Support-Seeking.|Regression, Linear|||||||0.04
72524562|NCT05849441|144579340|SUPERIORITY|||||||0.02||||||This is for subscale: Problem Solving|Regression, Linear|||||||0.02
72524563|NCT05849441|144579340|SUPERIORITY|||||||0.55||||||This is for subscale: Distancing|Regression, Linear|||||||0.55
72524564|NCT05849441|144579340|SUPERIORITY|||||||0.79||||||This is for subscale: Internalizing|Regression, Linear|||||||0.79
72524565|NCT05849441|144579340|SUPERIORITY|||||||0.93||||||This is for subscale: Externalizing|Regression, Linear|||||||0.93
72524566|NCT05849441|144579340|SUPERIORITY|||||||0.09||||||This is for subscale: Mindfulness|Regression, Linear|||||||0.09
72524567|NCT05849441|144579341|SUPERIORITY|||||||0.32||||||This is for subscale: Reappraisal|Regression, Linear|||||||0.32
72524568|NCT05849441|144579341|SUPERIORITY|||||||0.24||||||This is for subscale: Suppression|Regression, Linear|||||||0.24
72524569|NCT05849441|144579342|SUPERIORITY|||||||0.53||||||This is for subscale: Manage own emotions|Regression, Linear|||||||0.53
72524570|NCT05849441|144579342|SUPERIORITY|||||||0.16||||||This is for subscale: Identify and Understand Own Emotions|Regression, Linear|||||||0.16
72524571|NCT05849441|144579342|SUPERIORITY|||||||0.27||||||This is for subscale: Deal with emotions of others|Regression, Linear|||||||0.27
72524572|NCT05849441|144579342|SUPERIORITY|||||||0.59||||||This is for subscale: Perceive emotions through faces and bodies|Regression, Linear|||||||0.59
72524573|NCT05849441|144579343|SUPERIORITY|||||||0.16|||||||Regression, Linear|||||||0.16
72524574|NCT05849441|144579344|SUPERIORITY|||||||0.65||||||This is for subscale: Fear of Negative Evaluation|Regression, Linear|||||||0.65
72524575|NCT05849441|144579344|SUPERIORITY|||||||0.6||||||This is for subscale: Social avoidance and distress (new)|Regression, Linear|||||||0.60
72524576|NCT05849441|144579344|SUPERIORITY|||||||0.23||||||This is for subscale: social avoidance and distress (general)|Regression, Linear|||||||0.23
72524577|NCT05849441|144579345|SUPERIORITY|||||||0.55|||||||Regression, Linear|||||||0.55
72524578|NCT05849441|144579346|SUPERIORITY|||||||0.11||||||This is for subscale: Negativity|Regression, Linear|||||||0.11
72570986|NCT00546572|144670405|SUPERIORITY_OR_OTHER||Chan & Zhang|-6.8||||0.062|TWO_SIDED|95.0|-14.0|0.4|||Chan & Zhang||Exact 2-sided confidence interval and corresponding p-value (based on Chan \& Zhang) for the difference in proportions, \[13vPnC\] - \[23vPS\], expressed as a percentage.|Pain: any; difference in proportions, \[13vPnC\] - \[23vPS\], expressed as a percentage.||0.4|-14.0|0.062
72524579|NCT05849441|144579346|SUPERIORITY|||||||0.79||||||This is for subscale: Emotion regulation|Regression, Linear|||||||0.79
72524580|NCT05849441|144579347|SUPERIORITY|||||||0.14||||||This is for subscale: Working Memory|Regression, Linear|||||||0.14
72524581|NCT05849441|144579347|SUPERIORITY|||||||0.2||||||This is for subscale: Planning|Regression, Linear|||||||0.20
72524582|NCT05849441|144579347|SUPERIORITY|||||||0.48||||||This is for subscale: Inhibit|Regression, Linear|||||||0.48
72524583|NCT05849441|144579347|SUPERIORITY|||||||0.37||||||This is for subscale: Regulation|Regression, Linear|||||||0.37
72524584|NCT05849441|144579348|SUPERIORITY|||||||0.45|||||||Regression, Linear|||||||0.45
72524585|NCT05849441|144579349|SUPERIORITY|||||||0.88|||||||Regression, Linear|||||||0.88
72524586|NCT03277794|144579350|OTHER||Odds Ratio (OR)|2.28|STANDARD_ERROR_OF_MEAN|0.89||0.354|TWO_SIDED||||||Regression, Logistic|||Full HOP-C Service (Treatment) vs. Transitional Case Management Only (Control)||||0.354
72625221|NCT01098747|144780080|SUPERIORITY_OR_OTHER||LS mean difference|0.64||||0.008|TWO_SIDED|95.0|0.17|1.11||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1 hour: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.11|0.17|0.008
72369345|NCT00611026|144248572|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.2|STANDARD_ERROR_OF_MEAN|1.0||0.2208|TWO_SIDED|95.0|-0.7|3.1|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.|Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.|Treatment Difference Tolterodine ER vs placebo: HRQL social interaction domain.||3.1|-0.7|0.2208
72369346|NCT00611026|144248572|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.0|STANDARD_ERROR_OF_MEAN|0.8||0.0117|TWO_SIDED|95.0|0.4|3.5|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.|Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.|Treatment Difference Tolterodine ER vs Fesoterodine: HRQL social interaction domain.||3.5|0.4|0.0117
72369347|NCT05019521|144248574|SUPERIORITY||Least square (LS) mean difference|0.058|STANDARD_ERROR_OF_MEAN|0.0413||0.9205|TWO_SIDED|90.0|-0.01|0.126|||Mixed Models Analysis|||||0.126|-0.010|0.9205
72369348|NCT05019521|144248574|SUPERIORITY||LS mean difference|-0.016|STANDARD_ERROR_OF_MEAN|0.0425||0.9205|TWO_SIDED|90.0|-0.086|0.055|||Mixed Models Analysis|||||0.055|-0.086|0.9205
72369349|NCT05019521|144248574|SUPERIORITY||LS mean difference|0.037|STANDARD_ERROR_OF_MEAN|0.0422||0.9205|TWO_SIDED|90.0|-0.033|0.106|||Mixed Models Analysis|||||0.106|-0.033|0.9205
72369350|NCT04674761|144248631|SUPERIORITY||LS mean difference|-0.88|STANDARD_ERROR_OF_MEAN|0.277||0.0012|TWO_SIDED|95.0|-1.44|-0.33|||Mixed Models Analysis|||The analysis is based on a mixed model for repeated measures (MMRM) using a restricted maximum likelihood (REML) with baseline score as a covariate, and baseline age stratification, baseline direct bilirubin, treatment group, time (in months), and treatment-by-time interaction as fixed effects. One-sided p-value was reported.||-0.33|-1.44|0.0012
72369351|NCT04674761|144248632|SUPERIORITY||LS mean difference|-112.74|STANDARD_ERROR_OF_MEAN|32.864||0.0006|TWO_SIDED|95.0|-178.78|-46.69|||Mixed Models Analysis|||The analysis is based on a mixed model for repeated measures (MMRM) using a restricted maximum likelihood (REML) with baseline serum bile acid (sBA) concentration data as a covariate, and baseline age stratification, treatment group, visits (Weeks 4, 8, 12, 16, 20, 24), and treatment-by-visit interaction as fixed effects. The comparison of treatment difference in change from baseline to the average of Week 20 and Week 24 is estimated and tested using contrast. One-sided p-value was reported.||-46.69|-178.78|0.0006
72369352|NCT01500720|144248638|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|2.169|||<|0.0001|TWO_SIDED|95.0|1.563|3.01||P-value was calculated from stratified two-sided log-rank test, stratifying for brain metastases and lactate dehydrogenase (LDH) level at the time of randomization.|Stratified Two-Sided Log-Rank Test||Hazard ratio was estimated using a COX Proportional Hazards regression model, stratifying for brain metastases and LDH level at the time of randomization.|||3.01|1.563|<0.0001
72369353|NCT00806819|144248644|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.83||||0.0435|TWO_SIDED|95.0|0.7|0.99|||Regression, Cox||HR below 1 favors nintedanib|HR, CI and p-value obtained from the proportional hazards model stratified by baseline ECOG PS (0 vs 1), tumour histology (adenocarcinoma vs. non-adenocarcinoma), brain metastases at baseline (yes vs no) and prior treatment with bevacizumab (yes vs no).||0.99|0.70|0.0435
72369354|NCT00806819|144248645|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.01||||0.894|TWO_SIDED|95.0|0.85|1.21|||Regression, Cox||HR below 1 favors nintedanib|HR, CI and p-value obtained from the prop. hazards model stratified by baseline ECOG PS (0 vs 1), tumour histology (adenocarcinoma vs non-adenocarcinoma), brain metastases at baseline (yes vs no) and prior treatment with bevacizumab (yes vs no).||1.21|0.85|0.8940
72369355|NCT00806819|144248646|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.84||||0.0506|TWO_SIDED|95.0|0.7|1.0|||Regression, Cox||HR below 1 favors nintedanib|HR, CI and p-value obtained from the proportional hazards model stratified by baseline ECOG PS (0 vs 1), tumour histology (adenocarcinoma vs. non-adenocarcinoma), brain metastases at baseline (yes vs no) and prior treatment with bevacizumab (yes vs no)||1.00|0.70|0.0506
72369356|NCT00806819|144248647|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.86||||0.0865|TWO_SIDED|95.0|0.73|1.02|||Regression, Cox||HR below 1 favors nintedanib|HR, CI and p-value obtained from the proportional hazards model stratified by baseline ECOG PS (0 vs 1), tumour histology (adenocarcinoma vs. non-adenocarcinoma), brain metastases at baseline (yes vs no) and prior treatment with bevacizumab (yes vs no)||1.02|0.73|0.0865
72369357|NCT00806819|144248648|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.1||||0.7279|TWO_SIDED|95.0|0.65|1.85||Odds ratio and p-value are obtained from logistic regression model adjusted for baseline ECOG PS (0 vs 1)|Regression, Logistic||An odds ratio \>1 indicates a benefit to nintedanib|Analysis based on the central independent review||1.85|0.65|0.7279
72369358|NCT00806819|144248648|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.15||||0.518|TWO_SIDED|95.0|0.75|1.76||Odds ratio and p-value are obtained from logistic regression model adjusted for baseline ECOG PS (0 vs 1)|Regression, Logistic||An odds ratio \>1 indicates a benefit to nintedanib|Analysis based on the investigator's assessment||1.76|0.75|0.5180
72524587|NCT03277794|144579350|OTHER||Odds Ratio (OR)|2.01|STANDARD_ERROR_OF_MEAN|0.95||0.465|TWO_SIDED||||||Regression, Logistic|||Full HOP-C Service (Treatment) vs. Transitional Case Management Only (Control)||||0.465
72524588|NCT03277794|144579351|OTHER||Odds Ratio (OR)|2.31|STANDARD_ERROR_OF_MEAN|0.59||0.159|TWO_SIDED||||||Regression, Logistic|||Full HOP-C Service (Treatment) vs. Transitional Case Management Only (Control)||||0.159
72524589|NCT03277794|144579351|OTHER||Odds Ratio (OR)|2.3|STANDARD_ERROR_OF_MEAN|0.64||0.2|TWO_SIDED||||||Regression, Linear|||Full HOP-C Service (Treatment) vs. Transitional Case Management Only (Control)||||0.200
72524590|NCT03277794|144579352|OTHER||Odds Ratio (OR)|3.18|STANDARD_ERROR_OF_MEAN|0.74||0.121|TWO_SIDED||||||Regression, Logistic|||Full HOP-C Service (Treatment) vs. Transitional Case Management Only (Control)||||0.121
72524591|NCT03277794|144579352|OTHER||Odds Ratio (OR)|3.63|STANDARD_ERROR_OF_MEAN|0.85||0.134|TWO_SIDED||||||Regression, Logistic|||Full HOP-C Service (Treatment) vs. Transitional Case Management Only (Control)||||0.134
72524592|NCT03277794|144579353|OTHER|||||||0.899||||||Unadjusted.|Regression, Linear|||||||0.899
72524593|NCT03277794|144579353|OTHER|||||||0.128||||||Unadjusted|Regression, Linear|||||||0.128
72524594|NCT03277794|144579354|OTHER|||||||0.198||||||Unadjusted.|Regression, Linear|||||||0.198
72524595|NCT03277794|144579354|OTHER|||||||0.017||||||Unadjusted.|Regression, Linear|||||||0.017
72524596|NCT03277794|144579355|OTHER|||||||0.091||||||Unadjusted.|Regression, Linear|||||||0.091
72524597|NCT03277794|144579355|OTHER|||||||0.591||||||Unadjusted.|Regression, Linear|||||||0.591
72524598|NCT03277794|144579356|OTHER|||||||0.03||||||Unadjusted.|Regression, Linear|||||||0.030
72524599|NCT03277794|144579356|OTHER|||||||0.005||||||Unadjusted.|Regression, Linear|||||||0.005
72524600|NCT03277794|144579357|OTHER|||||||0.163||||||Unadjusted.|Regression, Linear|||||||0.163
72524601|NCT03277794|144579357|OTHER|||||||0.865||||||Unadjusted.|Regression, Linear|||||||0.865
72524602|NCT03277794|144579358|OTHER|||||||0.98||||||Unadjusted.|Regression, Linear|||||||0.980
72524603|NCT03277794|144579358|OTHER|||||||0.758||||||Unadjusted.|Regression, Linear|||||||0.758
72524604|NCT03277794|144579359|OTHER|||||||0.124||||||Unadjusted.|Regression, Linear|||||||0.124
72524605|NCT03277794|144579359|OTHER|||||||0.168||||||Unadjusted.|Regression, Linear|||||||0.168
72524606|NCT03277794|144579360|OTHER|||||||0.436||||||Unadjusted.|Regression, Linear|||||||0.436
72524607|NCT03277794|144579360|OTHER|||||||0.706||||||Unadjusted.|Regression, Linear|||||||0.706
72524608|NCT03277794|144579361|OTHER|||||||0.604||||||Unadjusted.|Regression, Linear|||Internalizing||||0.604
72524609|NCT03277794|144579361|OTHER|||||||0.177||||||Unadjusted.|Regression, Linear|||Internalizing||||0.177
72524610|NCT03277794|144579361|OTHER|||||||0.325||||||Unadjusted.|Regression, Linear|||Externalizing||||0.325
72524611|NCT03277794|144579361|OTHER|||||||0.227||||||Unadjusted.|Regression, Linear|||Externalizing||||0.227
72524612|NCT03277794|144579361|OTHER|||||||0.106||||||Unadjusted.|Regression, Linear|||Substance Use||||0.106
72524613|NCT03277794|144579361|OTHER|||||||0.058||||||Unadjusted.|Regression, Linear|||Substance Use||||0.058
72524614|NCT03277794|144579362|OTHER|||||||0.862||||||Unadjusted.|Regression, Linear|||Emotional Supports||||0.862
72524615|NCT03277794|144579362|OTHER|||||||0.382||||||Unadjusted.|Regression, Linear|||Emotional Supports||||0.382
72524616|NCT03277794|144579362|OTHER|||||||0.68||||||Unadjusted.|Regression, Linear|||Tangible Supports||||0.680
72524617|NCT03277794|144579362|OTHER|||||||0.988||||||Unadjusted.|Regression, Linear|||Tangible Supports||||0.988
72524618|NCT03277794|144579362|OTHER|||||||0.701||||||Unadjusted.|Regression, Linear|||Affectionate||||0.701
72524619|NCT03277794|144579362|OTHER|||||||0.154||||||Unadjusted.|Regression, Linear|||Affectionate||||0.154
72524620|NCT03277794|144579363|OTHER|||||||0.719||||||Unadjusted.|Regression, Linear|||Physical Health||||0.719
72524621|NCT03277794|144579363|OTHER|||||||0.15||||||Unadjusted.|Regression, Linear|||Physical Health||||0.150
72524622|NCT03277794|144579363|OTHER|||||||0.789||||||Unadjusted.|Regression, Linear|||Psychological||||0.789
72524623|NCT03277794|144579363|OTHER|||||||0.811||||||Unadjusted.|Regression, Linear|||Psychological||||0.811
72524624|NCT03277794|144579363|OTHER|||||||0.726||||||Unadjusted.|Regression, Linear|||Social||||0.726
72524625|NCT03277794|144579363|OTHER|||||||0.795||||||Unadjusted.|Regression, Linear|||Social||||0.795
72524626|NCT03277794|144579363|OTHER|||||||0.837||||||Unadjusted.|Regression, Linear|||Environment||||0.837
72524627|NCT03277794|144579363|OTHER|||||||0.048||||||Unadjusted.|Regression, Linear|||Environment||||0.048
72524628|NCT03399786|144579367|SUPERIORITY||Least Squares (LS) Mean Difference|-49.0|STANDARD_ERROR_OF_MEAN|8.0|<|0.0001|TWO_SIDED|95.0|-65.0|-33.1|||Mixed-effect Model Repeat Measure (MMRM)|||Confidence interval (CI) with p-value was based on-treatment group difference of least squares (LS) means using mixed-effect model repeat measurement (MMRM), randomization strata, treatment/strata/baseline value-by-time point interaction and continuous fixed covariates of baseline calculated LDL-C value.||-33.1|-65.0|< 0.0001
72524629|NCT03399786|144579368|SUPERIORITY||Least Squares (LS) Mean Difference|-36.9|STANDARD_ERROR_OF_MEAN|5.9|<|0.0001|TWO_SIDED|95.0|-48.6|-25.2|||Mixed-effect Model Repeat Measure (MMRM)|||A 2-sided hierarchical testing procedure was used for the secondary endpoints in a pre-specified order to control type I error. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level. CI with p-value was based on-treatment group difference of LS means using MMRM, randomization strata, treatment/strata/baseline value-by-time point interaction and continuous fixed covariates of baseline calculated Apo B value.||-25.2|-48.6|< 0.0001
72570987|NCT00546572|144670405|SUPERIORITY_OR_OTHER||difference in proportions|-4.0||||0.284|TWO_SIDED|95.0|-11.3|3.3|||Chan & Zhang||Exact 2-sided confidence interval and corresponding p-value (based on Chan \& Zhang) for the difference in proportions, \[13vPnC\] - \[23vPS\], expressed as a percentage.|Pain: mild; difference in proportions, \[13vPnC\] - \[23vPS\], expressed as a percentage.||3.3|-11.3|0.284
72524630|NCT03399786|144579369|SUPERIORITY||Least Squares (LS) Mean Difference|-51.7|STANDARD_ERROR_OF_MEAN|6.6|<|0.0001|TWO_SIDED|95.0|-64.8|-38.5|||Mixed-effect Model Repeat Measure (MMRM)|||A 2-sided hierarchical testing procedure was used for the secondary endpoints in a pre-specified order to control type I error. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level. CI with p-value was based on-treatment group difference of LS means using MMRM, randomization strata, treatment/strata/baseline value-by-time point interaction and continuous fixed covariates of baseline calculated non-HDL-C value.||-38.5|-64.8|< 0.0001
72625222|NCT01098747|144780080|SUPERIORITY_OR_OTHER||LS mean difference|4.06|||<|0.001|TWO_SIDED|95.0|3.4|4.72||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1.5 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||4.72|3.40|<0.001
72524631|NCT03399786|144579370|SUPERIORITY||Least Squares (LS) Mean Difference|-48.4|STANDARD_ERROR_OF_MEAN|5.1|<|0.0001|TWO_SIDED|95.0|-58.7|-38.1|||Mixed-effect Model Repeat Measure (MMRM)|||A 2-sided hierarchical testing procedure was used for the secondary endpoints in a pre-specified order to control type I error. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level. CI with p-value was based on-treatment group difference of LS means using MMRM, randomization strata, treatment/strata/baseline value-by-time point interaction and continuous fixed covariates of baseline calculated TC value.||-38.1|-58.7|< 0.0001
72524632|NCT03399786|144579371|SUPERIORITY|A 2-step multiple imputation method addressed missing values (seeds = 1629 \& 9261 with number of imputations = 100 in first and number of imputation=1 in second step).|Odds Ratio (OR)|25.2|||<|0.0001|TWO_SIDED|95.0|5.7|110.5|||Logistic Regression Models Analyses|||A 2-sided hierarchical testing procedure was used for secondary endpoints in pre-specified order to control type I error.Testing sequence continued only when previous endpoint was statistically significant at 0.05.Multiple imputation addressed missing data at week 24.Combined estimate for odds ratio obtained by Rubin's formulae.Logistic regression models stratified by randomized strata include fixed categorical effect of treatment group \& continuous fixed covariate of baseline calculated LDL-C.||110.5|5.7|< 0.0001
72524633|NCT03399786|144579372|SUPERIORITY|A 2-step multiple imputation method addressed missing values (seeds = 1629 \& 9261 with number of imputations = 100 in first and number of imputation=1 in second step).|Odds Ratio (OR)|24.2|||=|0.0028|TWO_SIDED|95.0|3.0|195.6|||Logistic Regression Models Analyses|||A 2-sided hierarchical testing procedure was used for secondary endpoints in pre-specified order to control type I error.Testing sequence continued only when previous endpoint was statistically significant at 0.05.Multiple imputation addressed missing data at week 24.Combined estimate for odds ratio obtained by Rubin's formulae.Logistic regression models stratified by randomized strata include fixed categorical effect of treatment group \& continuous fixed covariate of baseline calculated LDL-C.||195.6|3.0|= 0.0028
72524634|NCT03399786|144579373|SUPERIORITY||Least Squares (LS) Mean Difference|-132.1|STANDARD_ERROR_OF_MEAN|21.5|<|0.0001|TWO_SIDED|95.0|-175.3|-88.9|||Mixed-effect Model Repeat Measure (MMRM)|||A 2-sided hierarchical testing procedure was used for the secondary endpoints in a pre-specified order to control type I error. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level. CI with p-value was based on-treatment group difference of LS means using MMRM, randomization strata, treatment/strata/baseline value-by-time point interaction and continuous fixed covariates of baseline calculated LDL-C value.||-88.9|-175.3|< 0.0001
72524635|NCT03399786|144579374|SUPERIORITY|A 2-step multiple imputation method addressed missing values (seeds = 1629 \& 9261 with number of imputations = 100 in first and number of imputation=1 in second step).|Odds Ratio (OR)|0.1|||=|0.0845|TWO_SIDED|95.0|0.0|1.3|||Logistic Regression Models Analyses|||A 2-sided hierarchical testing procedure was used for the secondary endpoints in a pre-specified order to control type I error. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level. Combined estimate for odds ratio was obtained by using Rubin's formulae. Logistic regression models stratified the fixed categorical effect of treatment group and the continuous fixed covariate of baseline calculated LDL-C value.||1.3|0|= 0.0845
72524636|NCT03399786|144579375|SUPERIORITY|A 2-step multiple imputation method addressed missing values (seeds = 1629 \& 9261 with number of imputations = 100 in first and number of imputation=1 in second step).|Odds Ratio (OR)|5.7|||=|0.0203|TWO_SIDED|95.0|1.3|24.9||The p-value is nominal for descriptive purpose only due to statistical hypothesis testing terminated previously.|Logistic Regression Models Analyses|||A 2-sided hierarchical testing procedure was used for the secondary endpoints in a pre-specified order to control type I error. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level. Combined estimate for odds ratio was obtained by using Rubin's formulae. Logistic regression models stratified the fixed categorical effect of treatment group and the continuous fixed covariate of baseline calculated LDL-C value.||24.9|1.3|= 0.0203
72524637|NCT03399786|144579376|SUPERIORITY|A 2-step multiple imputation method addressed missing values (seeds = 1629 \& 9261 with number of imputations = 100 in first and number of imputation=1 in second step).|Odds Ratio (OR)|0.1|||=|0.0004|TWO_SIDED|95.0|0.0|0.3||The p-value is nominal for descriptive purpose only due to statistical hypothesis testing terminated previously.|Logistic Regression Models Analysis|||A 2-sided hierarchical testing procedure was used for the secondary endpoints in a pre-specified order to control type I error. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level. Combined estimate for odds ratio was obtained by using Rubin's formulae. Logistic regression models stratified the fixed categorical effect of treatment group and the continuous fixed covariate of baseline calculated LDL-C value.||0.3|0.0|= 0.0004
72524638|NCT00400946|144579387|SUPERIORITY|||||||0.6|||||||Fisher Exact|||||||.60
72524639|NCT04852666|144579417|SUPERIORITY|||||||0.751|||||||t-test, 2 sided|||||||0.751
72524640|NCT04852666|144579417|SUPERIORITY|||||||0.372|||||||t-test, 2 sided|||||||0.372
72524641|NCT04852666|144579418|SUPERIORITY|||||||0.778|||||||t-test, 2 sided|||||||0.778
72524642|NCT04852666|144579418|SUPERIORITY|||||||0.357|||||||t-test, 2 sided|||||||0.357
72524643|NCT04852666|144579419|SUPERIORITY|||||||0.012|||||||Chi-squared|||||||0.012
72524644|NCT04852666|144579419|SUPERIORITY|||||||0.956|||||||Chi-squared|||||||0.956
72524645|NCT04852666|144579420|SUPERIORITY|||||||0.103|||||||Chi-squared|||||||0.103
72524646|NCT04852666|144579420|SUPERIORITY|||||||0.025|||||||Chi-squared|||||||0.025
72524647|NCT04852666|144579421|SUPERIORITY|||||||0.785|||||||t-test, 2 sided|||||||0.785
72524648|NCT04852666|144579422|SUPERIORITY|||||||0.2|||||||t-test, 2 sided|||||||0.200
72524649|NCT04852666|144579423|SUPERIORITY|||||||0.887|||||||t-test, 2 sided|||||||0.887
72524650|NCT04852666|144579423|SUPERIORITY|||||||0.204|||||||t-test, 2 sided|||||||0.204
72524651|NCT05426460|144579424|SUPERIORITY|||||||0.438|||||||ANOVA|||2 x 2 ANOVA||||.438
72524652|NCT05426460|144579425|SUPERIORITY|||||||0.847|||||||ANOVA|||2 x 2 ANOVA||||.847
72524653|NCT05426460|144579426|SUPERIORITY|||||||0.57|||||||ANOVA|||2 X 2 ANOVA||||.570
72524654|NCT05426460|144579427|SUPERIORITY|||||||0.657|||||||ANOVA|||2 x 2 ANOVA||||.657
72524655|NCT05426460|144579428|SUPERIORITY|||||||0.254|||||||ANOVA|||2 x 2 ANOVA||||.254
72524656|NCT05426460|144579429|SUPERIORITY|||||||0.852|||||||ANOVA|||2 x 2 ANOVA with Main effect p-values for tDCS and AAT reported in comments below||||.852
72524657|NCT05426460|144579430|SUPERIORITY|||||||0.732|||||||ANOVA|||2 x 2 ANOVA||||.732
72524658|NCT05426460|144579431|SUPERIORITY|||||||0.038|||||||ANOVA|||2 x 2 ANOVA||||.038
72524659|NCT05426460|144579432|SUPERIORITY|||||||0.029|||||||ANOVA|||2 x 2 ANOVA||||.029
72524660|NCT05426460|144579433|SUPERIORITY|||||||0.353|||||||ANOVA|||2 x 2 ANOVA||||.353
72524661|NCT01431521|144579437|SUPERIORITY_OR_OTHER||Least squares mean difference|-44.37|||<|0.001|TWO_SIDED|95.0|-54.67|-34.07|||Linear mixed effects model|Treatment as fixed factor and predose Day 1 value, as a fixed covariate||||-34.07|-54.67|<0.001
72524662|NCT01431521|144579437|SUPERIORITY_OR_OTHER||Least squares mean difference|-26.67|||<|0.001|TWO_SIDED|95.0|-36.97|-16.37|||Linear mixed effects model|Treatment as fixed factor and predose Day 1 value, as a fixed covariate||||-16.37|-36.97|<0.001
72524663|NCT01431521|144579437|SUPERIORITY_OR_OTHER||least squares mean difference|-17.69||||0.007|TWO_SIDED|95.0|-36.97|-7.39|||Linear mixed effects model|Treatment as fixed factor and predose Day 1 value, as a fixed covariate||||-7.39|-36.97|0.007
72524664|NCT01431521|144579438|SUPERIORITY_OR_OTHER||Least square mean difference|-6.35|||>|0.2|TWO_SIDED|95.0|-18.69|6.0|||Linear mixed effect model|Containing fixed effects for treatment, and predose Day 1 (baseline) as a fixed covariate||||6.00|-18.69|>0.200
72524665|NCT01431521|144579438|SUPERIORITY_OR_OTHER||Least squares mean difference|-16.74||||0.028|TWO_SIDED|95.0|-29.08|-4.4|||Linear mixed effects model|Containing fixed effects for treatment, and predose Day 1 (baseline) as a fixed covariate||||-4.40|-29.08|0.028
72524666|NCT01431521|144579439|SUPERIORITY_OR_OTHER||Least squares mean difference|-3.47|||>|0.2|TWO_SIDED|95.0|-17.85|10.92|||Linear mixed effects model|Containing fixed effects for treatment, and predose Day 1 (baseline) as a fixed covariate||||10.92|-17.85|>0.200
72524667|NCT01431521|144579439|SUPERIORITY_OR_OTHER||Least squares mean difference|-10.67|||>|0.2|TWO_SIDED|95.0|-25.06|3.71|||Linear mixed effects model|Containing fixed effects for treatment, and predose Day 1 (baseline) as a fixed covariate||||3.71|-25.06|>0.200
72524668|NCT01320033|144579460|SUPERIORITY||Mean Difference (Final Values)|-3.6||||0.006|TWO_SIDED|95.0|-6.1|-1.1|||ANCOVA|||||-1.1|-6.1|0.006
72524669|NCT01320033|144579460|SUPERIORITY||Mean Difference (Final Values)|-2.9||||0.024|TWO_SIDED|95.0|-5.4|-0.4|||ANCOVA|||||-0.4|-5.4|0.024
72524670|NCT01320033|144579460|SUPERIORITY||Mean Difference (Final Values)|-0.7||||0.595|TWO_SIDED|95.0|-3.2|1.8|||ANCOVA|||||1.8|-3.2|0.595
72524671|NCT05241470|144579488|SUPERIORITY||Mean Difference (Net)|0.01||||0.9575|TWO_SIDED||||||ANCOVA|||||||0.9575
72524672|NCT05241470|144579488|SUPERIORITY||Mean Difference (Net)|0.01||||0.9741|TWO_SIDED||||||ANCOVA|||||||0.9741
72524673|NCT05241470|144579489|SUPERIORITY|||||||0.5696|||||||ANCOVA|||||||0.5696
72524674|NCT05241470|144579490|SUPERIORITY|||||||0.0266|||||||Fisher Exact|||||||0.0266
72524675|NCT05241470|144579491|SUPERIORITY|||||||0.0055|||||||ANCOVA|||||||0.0055
72524676|NCT05241470|144579492|SUPERIORITY|||||||0.0097|||||||ANCOVA|||||||0.0097
72524677|NCT05241470|144579493|SUPERIORITY|||||||0.0137|||||||ANCOVA|||||||0.0137
72524678|NCT05241470|144579494|SUPERIORITY|||||||0.0332|||||||ANCOVA|||||||0.0332
72524679|NCT05241470|144579495|SUPERIORITY|||||||0.0394|||||||t-test, 2 sided|||||||0.0394
72524680|NCT05241470|144579496|SUPERIORITY|||||||0.0121|||||||Wilcoxon (Mann-Whitney)|||||||0.0121
72524681|NCT05241470|144579497|SUPERIORITY|||||||0.0224|||||||Wilcoxon (Mann-Whitney)|||||||0.0224
72524682|NCT03558828|144579517|OTHER|A power analysis based on the study's primary aim (impact of augmented treatments on non-responders) was conducted. An estimated effect size of d=0.41 for the difference between the two augmented treatments was used. With a 2-tailed alpha of 0.05, a pre-post correlation of r=0.60, and a sample size of 188 non-responders, an estimated 80% power was obtained. Assuming 67% non-response to the initial treatments and 10% attrition, the final target sample size was N=312.|Effect size estimates|0.41|||||TWO_SIDED|95.0||||All analyses employed an intent-to-treat approach using a two-tailed alpha of 0.05 with no adjustment for multiple tests.|GEEs||Effect size estimates (Cohen's d) for all analyses were created by using the relevant slope (i.e., change) effect as the numerator and the baseline standard deviation of the dependent variable as the denominator.||"The longitudinal trajectories using generalized estimating equations (GEEs) were estimated. Cases for responders are duplicated and weighted based on the inverse probability of being assigned to a particular adaptive intervention (i.e., responders have a ½ probability of assignment to a specific adaptive intervention, and non-responders have a ¼ probability).~Only the Phase 1 (baseline to 8 weeks) treatment condition x time interaction was included because it preceded the randomization to Phase 2 (weeks 9-34) treatment conditions. Planned contrasts were used to test specific hypotheses. Effect size estimates for all analyses were created by using the relevant slope effect as the numerator and the baseline standard deviation of the dependent variable as the denominator. All analyses employed an intent-to-treat approach using a two-tailed alpha of 0.05 with no adjustment for multiple tests."|||
72542566|NCT01120600|144614970|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|1.69|||=|0.008|TWO_SIDED|95.0|0.45|2.93|||cLDA|||A cLDA method was used for this statistical analysis. The cLDA model included the baseline measurement and all post-baseline percent changes from baseline in the response vector, with fixed effects for treatment, time, geographic region, machine type and treatment-by-time interaction, geographic region-by-time interaction, and machine type-by-time interaction.||2.93|0.45|= 0.008
72524683|NCT03558828|144579518|OTHER|A power analysis based on the study's primary aim (impact of augmented treatments on non-responders) was conducted. An estimated effect size of d=0.41 for the difference between the two augmented treatments was used. With a 2-tailed alpha of 0.05, a pre-post correlation of r=0.60, and a sample size of 188 non-responders, an estimated 80% power was obtained. Assuming 67% non-response to the initial treatments and 10% attrition, the final target sample size was N=312.|Effect size estimates|0.41|||||TWO_SIDED|95.0||||All analyses employed an intent-to-treat approach using a two-tailed alpha of 0.05 with no adjustment for multiple tests.|GEEs||Effect size estimates for all analyses were created by using the relevant slope (i.e., change) effect as the numerator and the baseline standard deviation of the dependent variable as the denominator. An estimated effect size of d=0.41 was used.||There were time slope terms for Phase 1 (baseline to 8-week assessment), Phase 2 (9-weeks to 34-week assessment), and Phase 3 (maintenance from 35-weeks to 50-week assessment). Also, there were interactions of condition and time slopes. For Phase 1, only the Phase 1 treatment condition x time interaction was included because it preceded the randomization to Phase 2 treatment conditions. Supplementary analyses were conducted to compare the trajectories of responders versus non-responders to the Phase 1 treatment. Effect size estimates for all analyses were created by using the relevant slope (i.e., change) effect as the numerator and the baseline standard deviation of the dependent variable as the denominator. The resulting effect size is equivalent to a Cohen's d, representing mean change (or difference in change) in standard deviation units. All analyses employed an intent-to-treat approach using a two-tailed alpha of 0.05 with no adjustment for multiple tests.|||
72524684|NCT03671148|144579544|SUPERIORITY||Response Rate Difference|24.5|||<|0.001|TWO_SIDED|95.0|15.9|33.0||A fixed sequence testing procedure is used to control the overall type I error rate at 2-sided alpha = 0.05 for the primary endpoint and ranked secondary endpoints.|Cochran-Mantel-Haenszel|CMH test adjusted for the stratification factors of current use of csDMARD, number of prior biologic therapies, and extent of psoriasis at Baseline.|Response Rate Difference = Risankizumab - Placebo|The comparison between the risankizumab and placebo treatment groups for the primary efficacy endpoint (ACR20 at Week 24) was performed using the Cochran-Mantel-Haenszel (CMH) test adjusting for the stratification factors of current use of csDMARD (0 vs ≥ 1), number of prior biologic therapies (0 vs ≥ 1), and extent of psoriasis (≥ 3% BSA or \< 3% BSA) at Baseline.||33.0|15.9|<0.001
72524685|NCT03671148|144579545|SUPERIORITY||Least Squares (LS) Mean Difference|-0.16|||<|0.001|TWO_SIDED|95.0|-0.26|-0.07||A fixed sequence testing procedure is used to control the overall type I error rate at 2-sided alpha = 0.05 for the primary endpoint and ranked secondary endpoints.|Mixed Effect Model Repeated Measurement|MMRM analysis including treatment, visit, treatment-by-visit interaction, and stratification factors as fixed factors and Baseline value as covariate.|Difference = Risankizumab - Placebo|||-0.07|-0.26|<0.001
72524686|NCT03671148|144579546|SUPERIORITY||Response Rate Difference|44.3|||<|0.001|TWO_SIDED|95.0|33.9|54.6||A fixed sequence testing procedure is used to control the overall type I error rate at 2-sided alpha = 0.05 for the primary endpoint and ranked secondary endpoints.|Cochran-Mantel-Haenszel|CMH test adjusted for the stratification factors of current use of csDMARD, number of prior biologic therapies, and extent of psoriasis at Baseline.|Response Rate Difference = Risankizumab - Placebo|||54.6|33.9|<0.001
72625223|NCT01098747|144780080|SUPERIORITY_OR_OTHER||LS mean difference|0.58||||0.017|TWO_SIDED|95.0|0.1|1.06||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1.5 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.06|0.10|0.017
72625224|NCT01098747|144780080|SUPERIORITY_OR_OTHER||LS mean difference|4.09|||<|0.001|TWO_SIDED|95.0|3.42|4.75||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||2 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||4.75|3.42|<0.001
72625225|NCT01098747|144780080|SUPERIORITY_OR_OTHER||LS mean difference|0.22||||0.359|TWO_SIDED|95.0|-0.26|0.7||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||2 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.70|-0.26|0.359
72625226|NCT01098747|144780080|SUPERIORITY_OR_OTHER||LS mean difference|3.75|||<|0.001|TWO_SIDED|95.0|3.06|4.45||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||3 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||4.45|3.06|<0.001
72625227|NCT01098747|144780080|SUPERIORITY_OR_OTHER||LS mean difference|-0.2||||0.436|TWO_SIDED|95.0|-0.7|0.3||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||3 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.30|-0.70|0.436
72625228|NCT01098747|144780080|SUPERIORITY_OR_OTHER||LS mean difference|3.4|||<|0.001|TWO_SIDED|95.0|2.66|4.14||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||4 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||4.14|2.66|<0.001
72625229|NCT01098747|144780080|SUPERIORITY_OR_OTHER||LS mean difference|-0.4||||0.139|TWO_SIDED|95.0|-0.93|0.13||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||4 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.13|-0.93|0.139
72625230|NCT01098747|144780080|SUPERIORITY_OR_OTHER||LS mean difference|3.2|||<|0.001|TWO_SIDED|95.0|2.44|3.95||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||5 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||3.95|2.44|<0.001
72524687|NCT03671148|144579547|SUPERIORITY||Response Rate Difference|22.6|||<|0.001|TWO_SIDED|95.0|13.9|31.2||A fixed sequence testing procedure is used to control the overall type I error rate at 2-sided alpha = 0.05 for the primary endpoint and ranked secondary endpoints.|Cochran-Mantel-Haenszel|CMH test adjusted for the stratification factors of current use of csDMARD, number of prior biologic therapies, and extent of psoriasis at Baseline.|Response Rate Difference = Risankizumab - Placebo|||31.2|13.9|<0.001
72524688|NCT03671148|144579548|SUPERIORITY||Response Rate Difference|14.0|||<|0.001|TWO_SIDED|95.0|7.0|21.0||A fixed sequence testing procedure is used to control the overall type I error rate at 2-sided alpha = 0.05 for the primary endpoint and ranked secondary endpoints.|Cochran-Mantel-Haenszel|CMH test adjusted for the stratification factors of current use of csDMARD, number of prior biologic therapies, and extent of psoriasis at Baseline.|Response Rate Difference = Risankizumab - Placebo|||21.0|7.0|<0.001
72524689|NCT03671148|144579549|SUPERIORITY||LS Mean Difference|3.86|||<|0.001|TWO_SIDED|95.0|2.41|5.31||A fixed sequence testing procedure is used to control the overall type I error rate at 2-sided alpha = 0.05 for the primary endpoint and ranked secondary endpoints.|Mixed Effect Model Repeated Measurement|MMRM analysis including treatment, visit, treatment-by-visit interaction, and stratification factors as fixed factors and Baseline value as covariate.|Difference = Risankizumab - Placebo|||5.31|2.41|<0.001
72524690|NCT03671148|144579550|SUPERIORITY||LS Mean Difference|2.2||||0.009|TWO_SIDED|95.0|0.6|3.9||A fixed sequence testing procedure is used to control the overall type I error rate at 2-sided alpha = 0.05 for the primary endpoint and ranked secondary endpoints.|Mixed Effect Model Repeated Measurement|MMRM analysis including treatment, visit, treatment-by-visit interaction, and stratification factors as fixed factors and Baseline value as covariate.|Difference = Risankizumab - Placebo|||3.9|0.6|0.009
72570988|NCT00546572|144670405|SUPERIORITY_OR_OTHER||difference in proportions|-16.1|||<|0.001|TWO_SIDED|95.0|-21.7|-10.6|||Chan & Zhang||Exact 2-sided confidence interval and corresponding p-value (based on Chan \& Zhang) for the difference in proportions, \[13vPnC\] - \[23vPS\], expressed as a percentage.|Pain: moderate; difference in proportions, \[13vPnC\] - \[23vPS\], expressed as a percentage.||-10.6|-21.7|<0.001
72570989|NCT00546572|144670405|SUPERIORITY_OR_OTHER||difference in proportions|-0.9||||0.539|TWO_SIDED|95.0|-3.5|1.4|||Chan & Zhang||Exact 2-sided confidence interval and corresponding p-value (based on Chan \& Zhang) for the difference in proportions, \[13vPnC\] - \[23vPS\], expressed as a percentage.|Pain: severe; difference in proportions, \[13vPnC\] - \[23vPS\], expressed as a percentage.||1.4|-3.5|0.539
72570990|NCT00546572|144670405|SUPERIORITY_OR_OTHER||difference in proportions|-17.1|||<|0.001|TWO_SIDED|95.0|-23.1|-11.1|||Chan & Zhang||Exact 2-sided confidence interval and corresponding p-value (based on Chan \& Zhang) for the difference in proportions, \[13vPnC\] - \[23vPS\], expressed as a percentage.|Limitation of arm movement: any; difference in proportions, \[13vPnC\] - \[23vPS\], expressed as a percentage.||-11.1|-23.1|<0.001
72570991|NCT00546572|144670405|SUPERIORITY_OR_OTHER||difference in proportions|-14.9|||<|0.001|TWO_SIDED|95.0|-20.8|-9.0|||Chan & Zhang||Exact 2-sided confidence interval and corresponding p-value (based on Chan \& Zhang) for the difference in proportions, \[13vPnC\] - \[23vPS\], expressed as a percentage.|Limitation of arm movement: mild; difference in proportions, \[13vPnC\] - \[23vPS\], expressed as a percentage.||-9.0|-20.8|<0.001
72570992|NCT00546572|144670405|SUPERIORITY_OR_OTHER||difference in proportions|-2.3||||0.02|TWO_SIDED|95.0|-4.8|-0.4|||Chan & Zhang||Exact 2-sided confidence interval and corresponding p-value (based on Chan \& Zhang) for the difference in proportions, \[13vPnC\] - \[23vPS\], expressed as a percentage.|Limitation of arm movement: moderate; difference in proportions, \[13vPnC\] - \[23vPS\], expressed as a percentage.||-0.4|-4.8|0.020
72570993|NCT00546572|144670405|SUPERIORITY_OR_OTHER||difference in proportions|-2.3||||0.042|TWO_SIDED|95.0|-4.9|-0.1|||Limitation of arm movement: any; differe||Exact 2-sided confidence interval and corresponding p-value (based on Chan \& Zhang) for the difference in proportions, \[13vPnC\] - \[23vPS\], expressed as a percentage.|Limitation of arm movement: severe; difference in proportions, \[13vPnC\] - \[23vPS\], expressed as a percentage.||-0.1|-4.9|0.042
72570994|NCT00546572|144670410|SUPERIORITY_OR_OTHER||difference in proportions|-7.9||||0.034|TWO_SIDED|95.0|-15.2|-0.6|||Chan & Zhang||Exact 2-sided confidence interval and corresponding p-value (based on Chan \& Zhang) for the difference in proportions, \[13vPnC\] - \[23vPS\], expressed as a percentage.|New generalized muscle pain: difference in proportions, \[13vPnC\] - \[23vPS\], expressed as a percentage.||-0.6|-15.2|0.034
72570995|NCT00546572|144670410|SUPERIORITY_OR_OTHER||difference in proportions|-6.9||||0.039|TWO_SIDED|95.0|-13.6|-0.3|||Chan & Zhang||Exact 2-sided confidence interval and corresponding p-value (based on Chan \& Zhang) for the difference in proportions, \[13vPnC\] - \[23vPS\], expressed as a percentage.|Aggravated generalized muscle pain: difference in proportions, \[13vPnC\] - \[23vPS\], expressed as a percentage.||-0.3|-13.6|0.039
72570996|NCT01355159|144670415|SUPERIORITY||Risk Ratio (RR)|1.1||||0.37|TWO_SIDED|95.0|0.9|1.34|||Chi-squared|||||1.34|0.90|0.37
72570997|NCT01355159|144670417|SUPERIORITY||Risk Ratio (RR)|1.29||||0.37|TWO_SIDED|95.0|0.74|2.28|||Chi-squared|||||2.28|0.74|0.37
72570998|NCT01355159|144670418|SUPERIORITY||Risk Ratio (RR)|0.64||||0.21|TWO_SIDED|95.0|0.31|1.31|||Chi-squared|||||1.31|0.31|0.21
72570999|NCT01355159|144670419|SUPERIORITY||Risk Ratio (RR)|0.97||||0.71|TWO_SIDED|95.0|0.82|1.15|||Chi-squared|||||1.15|0.82|0.71
72571000|NCT01355159|144670420|SUPERIORITY||Risk Ratio (RR)|0.99||||0.87|TWO_SIDED|95.0|0.86|1.13|||Chi-squared|||||1.13|0.86|0.87
72571001|NCT01355159|144670421|SUPERIORITY||Risk Ratio (RR)|1.21||||0.75|TWO_SIDED|95.0|0.37|3.96|||Chi-squared|||||3.96|0.37|0.75
72571002|NCT01355159|144670422|SUPERIORITY||Risk Ratio (RR)|1.52||||0.19|TWO_SIDED|95.0|0.81|2.84|||Chi-squared|||||2.84|0.81|0.19
72571003|NCT01355159|144670423|SUPERIORITY||Mean Difference (Final Values)|0.34|STANDARD_DEVIATION|7.0||0.61|TWO_SIDED|95.0|-0.96|1.63|||t-test, 2 sided|||||1.63|-0.96|0.61
72571004|NCT01355159|144670424|SUPERIORITY||Risk Ratio (RR)|0.6||||0.14|TWO_SIDED|95.0|0.3|1.19|||Chi-squared|||||1.19|0.30|0.14
72571005|NCT01355159|144670425|SUPERIORITY||Risk Ratio (RR)|0.76||||0.37|TWO_SIDED|95.0|0.41|1.39|||Chi-squared|||||1.39|0.41|0.37
72571006|NCT01355159|144670426|SUPERIORITY||Risk Ratio (RR)|1.03||||0.82|TWO_SIDED|95.0|0.81|1.3|||Chi-squared|||||1.30|0.81|0.82
72524691|NCT03671148|144579551|SUPERIORITY||Response Rate Difference|16.6|||<|0.001|TWO_SIDED|95.0|9.7|23.6|||Cochran-Mantel-Haenszel|CMH test adjusted for the stratification factors of current use of csDMARD, number of prior biologic therapies, and extent of psoriasis at Baseline.|Response Rate Difference = Risankizumab - Placebo|||23.6|9.7|<0.001
72406515|NCT02942017|144321622|SUPERIORITY||LS Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.095||0.6694|TWO_SIDED|95.0|-0.23|0.15|||MMRM|||Hypochondriasis, Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.15|-0.23|0.6694
72524692|NCT03671148|144579552|SUPERIORITY||Response Rate Difference|6.0||||0.024|TWO_SIDED|95.0|0.8|11.3|||Cochran-Mantel-Haenszel|CMH test adjusted for the stratification factors of current use of csDMARD, number of prior biologic therapies, and extent of psoriasis at Baseline.|Response Rate Difference = Risankizumab - Placebo|||11.3|0.8|0.024
72524693|NCT03671148|144579553|SUPERIORITY||Response Rate Difference|13.8||||0.009|TWO_SIDED|95.0|3.5|24.2|||Cochran-Mantel-Haenszel|CMH test adjusted for the stratification factors of current use of csDMARD, number of prior biologic therapies, and extent of psoriasis at Baseline.|Response Rate Difference = Risankizumab - Placebo|||24.2|3.5|0.009
72524694|NCT03671148|144579554|SUPERIORITY||Response Rate Difference|38.8|||<|0.001|TWO_SIDED|95.0|22.9|54.8|||Cochran-Mantel-Haenszel|CMH test adjusted for the stratification factors of current use of csDMARD, number of prior biologic therapies, and extent of psoriasis at Baseline.|Response Rate Difference = Risankizumab - Placebo|||54.8|22.9|<0.001
72524695|NCT01250899|144579555|SUPERIORITY_OR_OTHER||Percentage of 12-wk 25(OH)D ≥30ng/mL|70.0|||<|0.05|TWO_SIDED|95.0|60.0|80.0|||Exact binomial||The primary endpoint (mean change in 25(OH)D following 12 weeks of vitamin D repletion in vitamin D insufficient subjects) was dichotomized to success or failure to achieve a week twelve 25(OH)D level ≥30ng/mL.|We predicted that HIV-infected subjects would have a 70% twelve-week repletion success rate compared to 85% among historical controls.Eighty subjects provided 91% power to detect a 12-week repletion rate statistically different than 85% (95% confidence interval (CI) 60%, 80%).||80|60|<0.05
72524696|NCT02234050|144579563|SUPERIORITY||Hazard Ratio (HR)|1.42||||0.204|TWO_SIDED|80.0|0.997|2.028|||Regression, Cox|||||2.028|0.997|0.204
72524697|NCT02234050|144579566|SUPERIORITY||Hazard Ratio (HR)|0.95||||0.94|TWO_SIDED|95.0|0.53|1.71|||Regression, Cox|||||1.71|0.53|0.94
72406516|NCT02942017|144321622|SUPERIORITY||LS Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.1||0.1113|TWO_SIDED|95.0|-0.36|0.04|||MMRM|||Hypochondriasis, Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.04|-0.36|0.1113
72524698|NCT02365506|144579568|SUPERIORITY||Difference in LSM|-7.7|STANDARD_ERROR_OF_MEAN|7.92||0.358|TWO_SIDED|95.0|-26.0|10.5|||Mixed Models Analysis|p-value is from a mixed model with fixed effect for treatment, day, and treatment by day with baseline daytime QTcF as a covariate.|Least Square mean (LSM) and 95% confidence interval (CI) is from a mixed model with fixed effect for treatment, day, and treatment by day with baseline daytime QTcF as a covariate.|||10.5|-26.0|0.358
72524699|NCT02365506|144579568|SUPERIORITY||Difference in LSM|-1.7|STANDARD_ERROR_OF_MEAN|7.96||0.84|TWO_SIDED|95.0|-20.0|16.7|||Mixed Models Analysis|p-value is from a mixed model with fixed effect for treatment, day, and treatment by day with baseline daytime QTcF as a covariate.|LSM and 95% CI are from a mixed model with fixed effect for treatment, day, and treatment by day with baseline daytime QTcF as a covariate.|||16.7|-20.0|0.840
72524700|NCT02365506|144579569|SUPERIORITY||Difference in LSM|-6.0|STANDARD_ERROR_OF_MEAN|5.83||0.338|TWO_SIDED|95.0|-19.8|7.8|||Mixed Models Analysis|p-value is from a mixed model with fixed effect for treatment, day, and treatment by day with baseline daytime QTcF as a covariate.|LSM and 95% CI are from a mixed model with fixed effect for treatment, day, and treatment by day with baseline daytime QTcF as a covariate.|||7.8|-19.8|0.338
72524701|NCT02365506|144579569|SUPERIORITY||Difference in LSM|5.3|STANDARD_ERROR_OF_MEAN|6.21||0.425|TWO_SIDED|95.0|-9.4|19.9|||Mixed Models Analysis|p-value is from a mixed model with fixed effect for treatment, day, and treatment by day with baseline daytime QTcF as a covariate.|LSM and 95% CI are from a mixed model with fixed effect for treatment, day, and treatment by day with baseline daytime QTcF as a covariate.|||19.9|-9.4|0.425
72524702|NCT02365506|144579570|SUPERIORITY||Difference in LSM|-6.5|STANDARD_ERROR_OF_MEAN|4.42||0.174|TWO_SIDED|95.0|-16.5|3.5|||Mixed Models Analysis|p-value is from a mixed model with fixed effect for treatment, day, and treatment by day with baseline daytime QTcF as a covariate.|LSM and 95% CI are from a mixed model with fixed effect for treatment, day, and treatment by day with baseline daytime QTcF as a covariate.|||3.5|-16.5|0.174
72524703|NCT02365506|144579570|SUPERIORITY||Difference in LSM|3.4|STANDARD_ERROR_OF_MEAN|4.28||0.448|TWO_SIDED|95.0|-6.3|13.1|||Mixed Models Analysis|p-value is from a mixed model with fixed effect for treatment, day, and treatment by day with baseline daytime QTcF as a covariate.|LSM and 95% CI are from a mixed model with fixed effect for treatment, day, and treatment by day with baseline daytime QTcF as a covariate.|||13.1|-6.3|0.448
72571007|NCT01355159|144670427|SUPERIORITY||Risk Ratio (RR)|0.87||||0.79|TWO_SIDED|95.0|0.31|2.44|||Chi-squared|||||2.44|0.31|0.79
72571008|NCT01355159|144670428|SUPERIORITY||Risk Ratio (RR)|0.63||||0.07|TWO_SIDED|95.0|0.37|1.05|||Chi-squared|||||1.05|0.37|0.07
72571009|NCT01355159|144670429|SUPERIORITY||Risk Ratio (RR)|1.2||||0.65|TWO_SIDED|95.0|0.54|2.66|||Chi-squared|||||2.66|0.54|0.65
72571010|NCT01355159|144670430|SUPERIORITY||Risk Ratio (RR)|0.34||||0.1|TWO_SIDED|95.0|0.09|1.23|||Chi-squared|||||1.23|0.09|0.10
72571011|NCT01355159|144670431|SUPERIORITY||Risk Ratio (RR)|2.04||||0.33|TWO_SIDED|95.0|0.49|8.57|||Chi-squared|||||8.57|0.49|0.33
72524704|NCT02365506|144579571|SUPERIORITY||Difference in LSM|8.8|STANDARD_ERROR_OF_MEAN|8.5||0.339|TWO_SIDED|95.0|-12.0|29.6|||Mixed Models Analysis|p-value is from a mixed model with fixed effect for treatment, day, and treatment by day with baseline daytime QTcF as a covariate.|LSM and 95% CI are from a mixed model with fixed effect for treatment, day, and treatment by day with baseline daytime QTcF as a covariate.|||29.6|-12.0|0.339
72625231|NCT01098747|144780080|SUPERIORITY_OR_OTHER||LS mean difference|-0.41||||0.144|TWO_SIDED|95.0|-0.95|0.14||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||5 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.14|-0.95|0.144
72524705|NCT02365506|144579571|SUPERIORITY||Difference in LSM|12.8|STANDARD_ERROR_OF_MEAN|8.4||0.178|TWO_SIDED|95.0|-7.7|33.4|||Mixed Models Analysis|p-value is from a mixed model with fixed effect for treatment, day, and treatment by day with baseline daytime QTcF as a covariate.|LSM and 95% CI are from a mixed model with fixed effect for treatment, day, and treatment by day with baseline daytime QTcF as a covariate.|||33.4|-7.7|0.178
72524706|NCT02365506|144579572|SUPERIORITY||Difference in LSM|4.9|STANDARD_ERROR_OF_MEAN|8.03||0.564|TWO_SIDED|95.0|-14.1|23.9|||Mixed Models Analysis|||||23.9|-14.1|0.564
72524707|NCT02365506|144579572|SUPERIORITY||Difference in LSM|2.7|STANDARD_ERROR_OF_MEAN|7.38||0.721|TWO_SIDED|95.0|-14.7|20.2|||Mixed Models Analysis|p-value is from a mixed model with fixed effect for treatment, day, and treatment by day with baseline daytime QTcF as a covariate.|LSM and 95% CI are from a mixed model with fixed effect for treatment, day, and treatment by day with baseline daytime QTcF as a covariate.|||20.2|-14.7|0.721
72524708|NCT00592176|144579576|SUPERIORITY_OR_OTHER|||||||0.83|||||||t-test, 2 sided|||||||0.83
72524709|NCT04088331|144579601|SUPERIORITY||||||<|0.001|||||||Exact binomial test|||"Hypotheses:~H0: p ≤ 0.65 H1: p \> 0.65 where p = the proportion of subjects who are a treatment success.~Hypotheses evaluated using a one-sided exact binomial test.~Power calculation assumed a treatment success rate of 80%. With a one-sided type I error of 0.025 and a type II error of 0.10 (90% power), a sample size of 96 subjects needed to demonstrate the proportion of subjects who are a treatment success exceeds 65%."||||< 0.001
72524710|NCT01994109|144579611|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
72524711|NCT01994109|144579611|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
72524712|NCT01994109|144579612|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
72524713|NCT01994109|144579612|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
72524714|NCT00435929|144579614|SUPERIORITY_OR_OTHER||Geometric mean ratio|0.656|||||TWO_SIDED|90.0|0.268|1.603||||||Comparison between normal liver function and moderate hepatic impairment for SQV||1.603|0.268|
72524715|NCT00435929|144579614|SUPERIORITY_OR_OTHER||Geometric mean ratio|0.764|||||TWO_SIDED|90.0|0.505|1.156||||||Comparison between normal liver function and moderate hepatic impairment for RTV.||1.156|0.505|
72524716|NCT00435929|144579615|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.716|||||TWO_SIDED|90.0|0.311|1.644||||||Comparison between normal liver function and moderate hepatic impairment for SQV.||1.644|0.311|
72524717|NCT00435929|144579615|SUPERIORITY_OR_OTHER||Geometric mean ratio|0.844|||||TWO_SIDED|90.0|0.551|1.292||||||Comparison between normal liver function and moderate hepatic impairment for RTV.||1.292|0.551|
72524718|NCT00976963|144579639|NON_INFERIORITY|The equivalence margin for non-inferiority of Fosfomycin to TMP/SMX is 10%.|||||<|0.001|||||||Wald test for noninferiority|||The null hypothesis is that Fosfomycin is inferior to TMP/SMX.||||<0.001
72524719|NCT03369704|144579667|OTHER||Least Square Mean|-1.03|STANDARD_ERROR_OF_MEAN|0.209|<|0.001|TWO_SIDED|95.0|-1.44|-0.62||"H0: Omalizumab is not different to placebo with respect to mean nasal symptom score over the severe symptom period.~H1: Omalizumab is different to placebo with respect to mean nasal symptom score over the severe symptom period."|ANCOVA||nasal symptom score|||-0.62|-1.44|<0.001
72524720|NCT03369704|144579668|OTHER||ANCOVA|-1.89|STANDARD_ERROR_OF_MEAN|0.331|||TWO_SIDED|95.0|-2.55|-1.24|||||Nasal Ocular Symptom|||-1.24|-2.55|
72524721|NCT03369704|144579668|OTHER||ANCOVA|-0.87|STANDARD_ERROR_OF_MEAN|0.159|||TWO_SIDED|95.0|-1.18|-0.55|||||Ocular symptom|||-0.55|-1.18|
72524722|NCT03369704|144579669|OTHER||ANCOVA|-1.1|STANDARD_ERROR_OF_MEAN|0.229|||TWO_SIDED|95.0|-1.55|-0.64|||||nasal symptom medication score|||-0.64|-1.55|
72524723|NCT03369704|144579669|OTHER||ANCOVA|-0.95|STANDARD_ERROR_OF_MEAN|0.189|||TWO_SIDED|95.0|-1.32|-0.58|||||ocular symptom medication score|||-0.58|-1.32|
72524724|NCT03369704|144579669|OTHER||ANCOVA|-2.05|STANDARD_ERROR_OF_MEAN|0.375|||TWO_SIDED|95.0|-2.78|-1.31|||||nasal ocular symptom medication score|||-1.31|-2.78|
72524725|NCT03369704|144579670|OTHER||ANCOVA|-0.4|STANDARD_ERROR_OF_MEAN|0.073|||TWO_SIDED|95.0|-0.54|-0.26|||||sneezing score|||-0.26|-0.54|
72524726|NCT03369704|144579670|OTHER||ANCOVA|-0.34|STANDARD_ERROR_OF_MEAN|0.088|||TWO_SIDED|95.0|-0.51|-0.16|||||rhinorrhea score|||-0.16|-0.51|
72524727|NCT03369704|144579670|OTHER||ANCOVA|-0.29|STANDARD_ERROR_OF_MEAN|0.081|||TWO_SIDED|95.0|-0.45|-0.13|||||nasal congestion score|||-0.13|-0.45|
72524728|NCT03369704|144579671|OTHER||ANCOVA|-0.47|STANDARD_ERROR_OF_MEAN|0.084|||TWO_SIDED|95.0|-0.63|-0.3|||||itchy eye score|||-0.30|-0.63|
72524729|NCT03369704|144579671|OTHER||ANCOVA|-0.4|STANDARD_ERROR_OF_MEAN|0.087|||TWO_SIDED|95.0|-0.57|-0.23|||||watery eye score|||-0.23|-0.57|
72524730|NCT03369704|144579672|OTHER||ANCOVA|-0.34|STANDARD_ERROR_OF_MEAN|0.072|||TWO_SIDED|95.0|-0.48|-0.2|||||score for impairment of daily activities|||-0.20|-0.48|
72524731|NCT03369704|144579673|OTHER||Hodges-Lehmann Estimate|3.0|STANDARD_ERROR_OF_MEAN|1.02||0.005|TWO_SIDED|95.0|1.0|5.0|||van Elteren test||Nasal symptom free days|||5.0|1.0|0.005
72524732|NCT03369704|144579673|OTHER||Hodges-Lehmann Estimate|4.0|STANDARD_ERROR_OF_MEAN|1.15|<|0.001|TWO_SIDED|95.0|2.0|6.5|||van Elteren test||Ocular symptom free days|||6.5|2.0|<0.001
72524733|NCT03369704|144579674|OTHER||Odds Ratio (OR)|3.43||||0.005|TWO_SIDED|95.0|1.21|9.75|||logistic regression||Completely nasal symptom free patients|||9.75|1.21|0.005
72524734|NCT03369704|144579675|OTHER||ANCOVA|-0.08|STANDARD_ERROR_OF_MEAN|0.033|||TWO_SIDED|95.0|-0.14|-0.01|||||Nasal rescue mediation score|||-0.01|-0.14|
72524735|NCT03369704|144579675|OTHER||ANCOVA|-0.08|STANDARD_ERROR_OF_MEAN|0.04|||TWO_SIDED|95.0|-0.16|0.0|||||Ocular rescue medication score|||0.00|-0.16|
72625232|NCT01098747|144780080|SUPERIORITY_OR_OTHER||LS mean difference|2.8|||<|0.001|TWO_SIDED|95.0|2.01|3.58||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||6 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||3.58|2.01|<0.001
72406517|NCT02942017|144321622|SUPERIORITY||LS Mean Difference|0.05|STANDARD_ERROR_OF_MEAN|0.089||0.5811|TWO_SIDED|95.0|-0.13|0.23|||MMRM|||Hypochondriasis, Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.23|-0.13|0.5811
72406518|NCT02942017|144321622|SUPERIORITY||LS Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.106||0.6794|TWO_SIDED|95.0|-0.25|0.17|||MMRM|||Hypochondriasis, Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.17|-0.25|0.6794
72406519|NCT02942017|144321622|SUPERIORITY||LS Mean Difference|0.05|STANDARD_ERROR_OF_MEAN|0.099||0.6031|TWO_SIDED|95.0|-0.14|0.25|||MMRM|||Hypochondriasis, Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.25|-0.14|0.6031
72524736|NCT03369704|144579675|OTHER||ANCOVA|-0.16|STANDARD_ERROR_OF_MEAN|0.063|||TWO_SIDED|95.0|-0.28|-0.04|||||Nasal ocular rescue medication score|||-0.04|-0.28|
72524737|NCT03369704|144579676|OTHER||Hodges-Lehmann Estimate|1.5|STANDARD_ERROR_OF_MEAN|0.89||0.011|TWO_SIDED|95.0|0.0|3.5|||van Elteren test||Nasal rescue mediation free days|||3.5|0.0|0.011
72524738|NCT03369704|144579676|OTHER||Hodges-Lehmann Estimate|2.0|STANDARD_ERROR_OF_MEAN|1.21||0.074|TWO_SIDED|95.0|0.0|4.8|||van Elteren test||Ocular rescue medication free days|||4.8|0.0|0.074
72524739|NCT03369704|144579676|OTHER||Hodges-Lehmann Estimate|1.8|STANDARD_ERROR_OF_MEAN|1.02||0.098|TWO_SIDED|95.0|0.0|4.0|||van Elteren test||Nasal ocular rescue medication free days|||4.0|0.0|0.098
72524740|NCT03369704|144579677|OTHER||Hodges-Lehmann Estimate|-2.0|STANDARD_ERROR_OF_MEAN|1.15||0.006|TWO_SIDED|95.0|-4.5|0.0|||van Elteren test||Nasal rescue mediation used|||0.0|-4.5|0.006
72524741|NCT03369704|144579677|OTHER||Hodges-Lehmann Estimate|-7.0|STANDARD_ERROR_OF_MEAN|2.81||0.012|TWO_SIDED|95.0|-12.0|-1.0|||van Elteren test||Ocular rescue medication used|||-1.0|-12.0|0.012
72524742|NCT03369704|144579678|OTHER||ANCOVA|-0.5|STANDARD_ERROR_OF_MEAN|0.086|||TWO_SIDED|95.0|-0.66|-0.33|||||JRQLQ I|||-0.33|-0.66|
72524743|NCT03369704|144579678|OTHER||ANCOVA|-0.51|STANDARD_ERROR_OF_MEAN|0.093|||TWO_SIDED|95.0|-0.69|-0.33|||||JRQLQ II|||-0.33|-0.69|
72524744|NCT03369704|144579678|OTHER||ANCOVA|-0.6|STANDARD_ERROR_OF_MEAN|0.1|||TWO_SIDED|95.0|-0.8|-0.4|||||JRQLQ III|||-0.4|-0.8|
72524745|NCT02148952|144579685|SUPERIORITY|We hypothesized a 15% reduction in the composite outcome between the intervention and control arm.|Risk Ratio (RR)|0.99||||0.9|TWO_SIDED|95.0|0.83|1.18|||Chi-squared, Corrected|In secondary analyses, a Rao-Scott test with 3 degrees of freedom resulted in a p value of 0.88.|Relative risks are for the intervention group as compared with the control group and are adjusted for clustering and matching. The denominators shift owing to missing data on outcomes.|||1.18|0.83|0.90
72524746|NCT02148952|144579686|SUPERIORITY||Risk Ratio (RR)|1.03||||0.67|TWO_SIDED|95.0|0.89|1.2|||Chi-squared, Corrected||Relative risks are for the intervention group as compared with the control group and are adjusted for clustering and matching. The denominators shift owing to missing data on outcomes.|||1.20|0.89|0.67
72524747|NCT02148952|144579687|SUPERIORITY||Risk Ratio (RR)|1.03||||0.68|TWO_SIDED|95.0|0.89|1.2|||Chi-squared, Corrected|||||1.20|0.89|0.68
72524748|NCT02148952|144579688|SUPERIORITY||Risk Ratio (RR)|0.94||||0.56|TWO_SIDED|95.0|0.76|1.16|||Chi-squared, Corrected||Relative risks are for the intervention group as compared with the control group and are adjusted for clustering and matching. The denominators shift owing to missing data on outcomes.|||1.16|0.76|0.56
72524749|NCT02148952|144579689|SUPERIORITY||Risk Ratio (RR)|1.1||||0.19|TWO_SIDED|95.0|0.95|1.27|||Chi-squared, Corrected|||||1.27|0.95|0.19
72524750|NCT02148952|144579690|SUPERIORITY||Risk Ratio (RR)|1.11||||0.73|TWO_SIDED|95.0|0.74|1.53|||Chi-squared, Corrected||Relative risks are for the intervention group as compared with the control group and are adjusted for clustering and matching. The denominators shift owing to missing data on outcomes.|||1.53|0.74|0.73
72524751|NCT02148952|144579691|SUPERIORITY||Risk Ratio (RR)|0.97||||0.81|TWO_SIDED|95.0|0.79|1.2|||Chi-squared, Corrected||Relative risks are for the intervention group as compared with the control group and are adjusted for clustering and matching. The denominators shift owing to missing data on outcomes.|Rate any severe maternal complication within 7 days||1.20|0.79|0.81
72524752|NCT02148952|144579691|SUPERIORITY||Risk Ratio (RR)|0.89||||0.76|TWO_SIDED|95.0|0.57|1.52|||Chi-squared, Corrected||Relative risks are for the intervention group as compared with the control group and are adjusted for clustering and matching. The denominators shift owing to missing data on outcomes.|Rate of seizures||1.52|0.57|0.76
72524753|NCT02148952|144579691|SUPERIORITY||Risk Ratio (RR)|0.98||||0.97|TWO_SIDED|95.0|0.7|1.41|||Chi-squared, Corrected||Relative risks are for the intervention group as compared with the control group and are adjusted for clustering and matching. The denominators shift owing to missing data on outcomes.|Rate of loss of consciousness for \> 1 hr||1.41|0.70|0.97
72524754|NCT02148952|144579691|SUPERIORITY||Risk Ratio (RR)|1.02||||0.9|TWO_SIDED|95.0|0.76|1.38|||Chi-squared, Corrected||Relative risks are for the intervention group as compared with the control group and are adjusted for clustering and matching. The denominators shift owing to missing data on outcomes.|Rate of high fever with foul-smelling vaginal discharge||1.38|0.76|0.90
72524755|NCT02148952|144579691|SUPERIORITY||Risk Ratio (RR)|0.95||||0.61|TWO_SIDED|95.0|0.77|1.17|||Chi-squared, Corrected||Relative risks are for the intervention group as compared with the control group and are adjusted for clustering and matching. The denominators shift owing to missing data on outcomes.|Rate of hemorrhage||1.17|0.77|0.61
72524756|NCT02148952|144579691|SUPERIORITY||Risk Ratio (RR)|0.5||||0.41|TWO_SIDED|95.0|0.34|1.58|||Chi-squared, Corrected||Relative risks are for the intervention group as compared with the control group and are adjusted for clustering and matching. The denominators shift owing to missing data on outcomes.|Rate of stroke||1.58|0.34|0.41
72524757|NCT02148952|144579692|SUPERIORITY||Risk Ratio (RR)|1.07||||0.74|TWO_SIDED|95.0|0.72|1.58|||Chi-squared, Corrected|||||1.58|0.72|0.74
72524758|NCT02148952|144579693|SUPERIORITY||Risk Ratio (RR)|1.09||||0.57|TWO_SIDED|95.0|0.81|1.47|||Chi-squared, Corrected||Relative risks are for the intervention group as compared with the control group and are adjusted for clustering and matching. The denominators shift owing to missing data on outcomes.|||1.47|0.81|0.57
72524759|NCT02148952|144579694|SUPERIORITY||Risk Ratio (RR)|1.19||||0.41|TWO_SIDED|95.0|0.78|1.8|||Chi-squared, Corrected||Relative risks are for the intervention group as compared with the control group and are adjusted for clustering and matching. The denominators shift owing to missing data on outcomes.|||1.80|0.78|0.41
72524760|NCT02148952|144579695|SUPERIORITY||Risk Ratio (RR)|1.0||||0.95|TWO_SIDED|95.0|0.45|2.13|||Chi-squared, Corrected||Relative risks are for the intervention group as compared with the control group and are adjusted for clustering and matching. The denominators shift owing to missing data on outcomes.|||2.13|0.45|0.95
72524761|NCT02148952|144579696|SUPERIORITY||Risk Ratio (RR)|0.99||||0.97|TWO_SIDED|95.0|0.69|1.43|||Chi-squared, Corrected|||||1.43|0.69|0.97
72571012|NCT01355159|144670432|SUPERIORITY||Risk Ratio (RR)|0.97||||0.94|TWO_SIDED|95.0|0.47|2.0|||Chi-squared|||||2.00|0.47|0.94
72571013|NCT01355159|144670433|SUPERIORITY||Risk Ratio (RR)|1.61||||0.06|TWO_SIDED|95.0|0.97|2.66|||Chi-squared|||||2.66|0.97|0.06
72571014|NCT01355159|144670434|SUPERIORITY||Risk Ratio (RR)|2.37||||0.21|TWO_SIDED|95.0|0.61|9.14|||Chi-squared|||||9.14|0.61|0.21
72524762|NCT02148952|144579697|SUPERIORITY||Risk Ratio (RR)|0.91||||0.32|TWO_SIDED|95.0|0.76|1.1|||Chi-squared, Corrected||Relative risks are for the intervention group as compared with the control group and are adjusted for clustering and matching. The denominators shift owing to missing data on outcomes.|||1.10|0.76|0.32
72524763|NCT02148952|144579698|SUPERIORITY||Risk Ratio (RR)|0.92||||0.3|TWO_SIDED|95.0|0.78|1.08|||Chi-squared, Corrected||Relative risks are for the intervention group as compared with the control group and are adjusted for clustering and matching. The denominators shift owing to missing data on outcomes.|||1.08|0.78|0.30
72524764|NCT02148952|144579699|SUPERIORITY||Other|0.0|||<|0.001|TWO_SIDED||||||Chi-squared, Corrected|||||||<0.001
72524765|NCT02148952|144579700|SUPERIORITY||Other|0.0||||0.18|TWO_SIDED||||||Chi-squared, Corrected||The relative risk could not be calculated owing to 100% or 0% values in one group.|Birth Companion Present||||0.18
72524766|NCT02148952|144579700|SUPERIORITY||Risk Ratio (RR)|9.8|||<|0.001|TWO_SIDED|95.0|3.4|28.3|||Chi-squared, Corrected|||Maternal blood pressure taken||28.3|3.4|<0.001
72524767|NCT02148952|144579700|SUPERIORITY||Risk Ratio (RR)|132.0|||<|0.001|TWO_SIDED|95.0|26.9|645.0|||Chi-squared, Corrected|||Maternal temperature taken||645|26.9|<0.001
72524768|NCT02148952|144579700|SUPERIORITY||Risk Ratio (RR)|7.3||||0.01|TWO_SIDED|95.0|1.5|35.6|||Chi-squared, Corrected|||Partography started||35.6|1.5|0.01
72524769|NCT02148952|144579700|SUPERIORITY||Risk Ratio (RR)|413.0|||<|0.001|TWO_SIDED|95.0|65.8|2589.0|||Chi-squared, Corrected|||Checklist use||2589|65.8|<0.001
72524770|NCT02148952|144579701|SUPERIORITY||Risk Ratio (RR)|53.3|||<|0.001|TWO_SIDED|95.0|13.1|217.0|||Chi-squared, Corrected|||Hand hygiene||217|13.1|<0.001
72524771|NCT02148952|144579701|SUPERIORITY||Risk Ratio (RR)|2.3||||0.007|TWO_SIDED|95.0|1.3|4.2|||Chi-squared, Corrected|||No oxytocin given before delivery||4.2|1.3|0.007
72524772|NCT02148952|144579701|SUPERIORITY||Risk Ratio (RR)|5.7|||<|0.001|TWO_SIDED|95.0|2.7|12.1|||Chi-squared, Corrected|||Clean towel available||12.1|2.7|<0.001
72524773|NCT02148952|144579701|SUPERIORITY||Risk Ratio (RR)|1.1||||0.72|TWO_SIDED|95.0|0.7|1.7|||Chi-squared, Corrected|||Clean scissors or blade available||1.7|0.7|0.72
72524774|NCT02148952|144579701|SUPERIORITY||Risk Ratio (RR)|1.0||||0.48|TWO_SIDED|95.0|1.0|1.0|||Chi-squared, Corrected|||Cord tie available||1.0|1.0|0.48
72524775|NCT02148952|144579701|SUPERIORITY||Risk Ratio (RR)|1.0||||0.73|TWO_SIDED|95.0|0.9|1.1|||Chi-squared, Corrected|||Mucus extractor available||1.1|0.9|0.73
72524776|NCT02148952|144579701|SUPERIORITY||Risk Ratio (RR)|1.0||||0.56|TWO_SIDED|95.0|0.9|1.1|||Chi-squared, Corrected|||Neonatal bag and mask available||1.1|0.9|0.56
72571015|NCT01355159|144670435|SUPERIORITY||Risk Ratio (RR)|1.2||||0.38|TWO_SIDED|95.0|0.8|1.8|||Chi-squared|||||1.80|0.80|0.38
72571016|NCT01355159|144670436|SUPERIORITY||Mean Difference (Net)|-1.6||||46|TWO_SIDED|95.0|-5.84|2.64|||t-test, 2 sided|||||2.64|-5.84|046
72571017|NCT01355159|144670437|SUPERIORITY||Risk Ratio (RR)|0.87||||0.79|TWO_SIDED|95.0|0.31|2.44|||Chi-squared|||||2.44|0.31|0.79
72571018|NCT01355159|144670438|SUPERIORITY||Risk Ratio (RR)|2.0||||0.42|TWO_SIDED|95.0|0.37|10.92|||Chi-squared|||||10.92|0.37|0.42
72571019|NCT04700280|144670440|SUPERIORITY||LS Mean Difference|-1.4|STANDARD_ERROR_OF_MEAN|2.69||0.617|TWO_SIDED|90.0|-6.2|3.4|||Mixed Models Analysis|||||3.4|-6.2|0.617
72571020|NCT04700280|144670442|SUPERIORITY||LS Mean Difference|-0.64|STANDARD_ERROR_OF_MEAN|0.62||0.3089|TWO_SIDED|90.0|-1.7|0.41|||Mixed Models Analysis|||Week 4||0.41|-1.70|0.3089
72571021|NCT04700280|144670442|SUPERIORITY||LS Mean Difference|-0.77|STANDARD_ERROR_OF_MEAN|0.71||0.2834|TWO_SIDED|90.0|-1.97|0.43|||Mixed Models Analysis|||Week 8||0.43|-1.97|0.2834
72571022|NCT04700280|144670442|SUPERIORITY||LS Mean Difference|-0.36|STANDARD_ERROR_OF_MEAN|0.95||0.7109|TWO_SIDED|90.0|-2.02|1.3|||Mixed Models Analysis|||Week 12||1.30|-2.02|0.7109
72571023|NCT04700280|144670443|SUPERIORITY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|1.81||0.859|TWO_SIDED|90.0|-3.6|2.9|||Mixed Models Analysis|||Week 4||2.9|-3.6|0.859
72571024|NCT04700280|144670443|SUPERIORITY||LS Mean Difference|0.5|STANDARD_ERROR_OF_MEAN|2.46||0.837|TWO_SIDED|90.0|-3.8|4.8|||Mixed Models Analysis|||Week 8||4.8|-3.8|0.837
72406520|NCT02942017|144321622|SUPERIORITY||LS Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.099||0.6673|TWO_SIDED|95.0|-0.24|0.15|||MMRM|||Hypochondriasis, Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.15|-0.24|0.6673
72524777|NCT02148952|144579701|SUPERIORITY||Risk Ratio (RR)|2.1||||0.005|TWO_SIDED|95.0|1.3|3.5|||Chi-squared, Corrected|||Pads available||3.5|1.3|0.005
72524778|NCT02148952|144579701|SUPERIORITY||Risk Ratio (RR)|185.0|||<|0.001|TWO_SIDED|95.0|19.7|1738.0|||Chi-squared, Corrected|||Checklist use||1738|19.7|<0.001
72524779|NCT02148952|144579702|SUPERIORITY||Risk Ratio (RR)|3.9|||<|0.001|TWO_SIDED|95.0|2.1|7.2|||Chi-squared, Corrected|||Oxytocin administered||7.2|2.1|<0.001
72524780|NCT02148952|144579702|SUPERIORITY||Risk Ratio (RR)|0.6||||0.25|TWO_SIDED|95.0|0.3|1.4|||Chi-squared, Corrected|||Neonatal bag used||1.4|0.3|0.25
72524781|NCT02148952|144579702|SUPERIORITY||Risk Ratio (RR)|1.0||||0.25|TWO_SIDED|95.0|1.0|1.0|||Chi-squared, Corrected|||Birth attendant present||1.0|1.0|0.25
72524782|NCT02148952|144579703|SUPERIORITY||Risk Ratio (RR)|1.1||||0.25|TWO_SIDED|95.0|0.9|1.4|||Chi-squared, Corrected|||Newborn weight taken||1.4|0.9|0.25
72524783|NCT02148952|144579703|SUPERIORITY||Risk Ratio (RR)|317.0|||<|0.001|TWO_SIDED|95.0|50.4|1989.0|||Chi-squared, Corrected|||Newborn temperature taken||1989|50.4|<0.001
72524784|NCT02148952|144579703|SUPERIORITY||Risk Ratio (RR)|7.3|||<|0.001|TWO_SIDED|95.0|2.4|22.0|||Chi-squared, Corrected|||Skin-to-skin care initiated at birth||22.0|2.4|<0.001
72524785|NCT02148952|144579703|SUPERIORITY||Risk Ratio (RR)|38.7|||<|0.001|TWO_SIDED|95.0|7.7|194.0|||Chi-squared, Corrected|||Skin-to-skin care maintained for 1 hr||194|7.7|<0.001
72524786|NCT02148952|144579703|SUPERIORITY||Risk Ratio (RR)|19.4|||<|0.001|TWO_SIDED|95.0|11.4|33.2|||Chi-squared, Corrected|||Initiation of breast-feeding||33.2|11.4|<0.001
72524787|NCT02148952|144579703|SUPERIORITY||Other|0.0|||<|0.001|TWO_SIDED||||||Chi-squared, Corrected||The relative risk could not be calculated owing to 100% or 0% values in one group.|Checklist use||||<0.001
72406521|NCT02942017|144321622|SUPERIORITY||LS Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.102||0.6472|TWO_SIDED|95.0|-0.25|0.16|||MMRM|||Hypochondriasis, Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.16|-0.25|0.6472
72524788|NCT02148952|144579704|SUPERIORITY||Risk Ratio (RR)|182.0|||<|0.001|TWO_SIDED|95.0|33.5|993.0|||Chi-squared, Corrected|||Maternal temperature taken||993|33.5|<0.001
72524789|NCT02148952|144579704|SUPERIORITY||Risk Ratio (RR)|9.9|||<|0.001|TWO_SIDED|95.0|3.8|25.8|||Chi-squared, Corrected|||Maternal blood pressure taken||25.8|3.8|<0.001
72524790|NCT02148952|144579704|SUPERIORITY||Risk Ratio (RR)|0.4||||0.3|TWO_SIDED|95.0|0.1|2.1|||Chi-squared, Corrected|||Mother given magnesium sulfate||2.1|0.1|0.30
72524791|NCT02148952|144579705|SUPERIORITY||Other|0.0|||<|0.001|TWO_SIDED||||||Chi-squared, Corrected|||||||<0.001
72524792|NCT02148952|144579706|SUPERIORITY||Risk Ratio (RR)|1.0||||1|TWO_SIDED|95.0|1.0|1.0|||Chi-squared, Corrected|||Birth companion present||1.0|1.0|1.00
72524793|NCT02148952|144579706|SUPERIORITY||Risk Ratio (RR)|19.1|||<|0.001|TWO_SIDED|95.0|7.9|46.5|||Chi-squared, Corrected|||Maternal blood pressure taken||46.5|7.9|<0.001
72524794|NCT02148952|144579706|SUPERIORITY||Other|0.0|||<|0.001|TWO_SIDED||||||Chi-squared, Corrected||The relative risk could not be calculated due to 100% or 0% values in one group.|Maternal temperature taken||||<0.001
72524795|NCT02148952|144579706|SUPERIORITY||Other|0.0|||<|0.001|TWO_SIDED||||||Chi-squared, Corrected||The relative risk could not be calculated owing to 100% or 0% values in one group.|Partography started||||<0.001
72524796|NCT02148952|144579706|SUPERIORITY||Other|0.0|||<|0.001|TWO_SIDED||||||Chi-squared, Corrected||The relative risk could not be calculated owing to 100% or 0% values in one group.|Checklist use||||<0.001
72524797|NCT02148952|144579707|SUPERIORITY||Risk Ratio (RR)|19.9|||<|0.001|TWO_SIDED|95.0|6.6|60.4|||Chi-squared, Corrected|||Hand hygiene||60.4|6.6|<0.001
72524798|NCT02148952|144579707|SUPERIORITY||Risk Ratio (RR)|2.1||||0.04|TWO_SIDED|95.0|1.0|4.1|||Chi-squared, Corrected|||No oxytocin given before delivery||4.1|1.0|0.04
72524799|NCT02148952|144579707|SUPERIORITY||Risk Ratio (RR)|2.4||||0.006|TWO_SIDED|95.0|1.3|4.3|||Chi-squared, Corrected|||Clean towel available||4.3|1.3|0.006
72524800|NCT02148952|144579707|SUPERIORITY||Risk Ratio (RR)|1.0||||0.34|TWO_SIDED|95.0|1.0|1.1|||Chi-squared, Corrected|||Clean scissors or blade available||1.1|1.0|0.34
72524801|NCT02148952|144579707|SUPERIORITY||Risk Ratio (RR)|1.0||||0.25|TWO_SIDED|95.0|1.0|1.0|||Chi-squared, Corrected|||Cord tie available||1.0|1.0|0.25
72524802|NCT02148952|144579707|SUPERIORITY||Risk Ratio (RR)|1.0||||0.5|TWO_SIDED|95.0|1.0|1.1|||Chi-squared, Corrected|||Mucus extractor available||1.1|1.0|0.50
72524803|NCT02148952|144579707|SUPERIORITY||Risk Ratio (RR)|1.0||||0.32|TWO_SIDED|95.0|1.0|1.0|||Chi-squared, Corrected|||Neonatal bag and mask available||1.0|1.0|0.32
72524804|NCT02148952|144579707|SUPERIORITY||Risk Ratio (RR)|1.4||||0.11|TWO_SIDED|95.0|0.9|2.1|||Chi-squared, Corrected|||Pads available||2.1|0.9|0.11
72524805|NCT02148952|144579707|SUPERIORITY||Risk Ratio (RR)|37.9|||<|0.001|TWO_SIDED|95.0|7.3|196.0|||Chi-squared, Corrected|||Checklist available||196|7.3|<0.001
72524806|NCT02148952|144579708|SUPERIORITY||Risk Ratio (RR)|3.6|||<|0.001|TWO_SIDED|95.0|1.8|7.5|||Chi-squared, Corrected|||Oxytocin administered||7.5|1.8|<0.001
72524807|NCT02148952|144579708|SUPERIORITY||Risk Ratio (RR)|0.6||||0.19|TWO_SIDED|95.0|0.3|1.3|||Chi-squared, Corrected|||Neonatal bag used||1.3|0.3|0.19
72524808|NCT02148952|144579708|SUPERIORITY||Risk Ratio (RR)|1.0||||0.5|TWO_SIDED|95.0|1.0|1.0|||Chi-squared, Corrected|||Birth companion present||1.0|1.0|0.50
72524809|NCT02148952|144579709|SUPERIORITY||Risk Ratio (RR)|1.1||||0.08|TWO_SIDED|95.0|1.0|1.3|||Chi-squared, Corrected|||Newborn weight taken||1.3|1.0|0.08
72524810|NCT02148952|144579709|SUPERIORITY||Risk Ratio (RR)|91.5|||<|0.001|TWO_SIDED|95.0|11.0|758.0|||Chi-squared, Corrected|||Newborn temperature taken||758|11.0|<0.001
72571025|NCT00741936|144670460|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Chi-squared|||||||<0.05
72571026|NCT00741936|144670461|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0|||||t-test, 2 sided|T-Tests were implemented: 1) between two groups of each time frame; 2) between each treatment group of each time frame and its baseline.||||||<0.05
72571027|NCT00741936|144670462|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0|||||t-test, 2 sided|T-Tests were implemented: 1) between two groups of each time frame; 2) between each treatment group of each time frame and its baseline||||||<0.05
72571028|NCT00741936|144670463|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0|||||t-test, 2 sided|T-Tests were implemented: 1) between two groups of each time frame; 2) between each treatment group of each time frame and its baseline.||||||<0.05
72571029|NCT00741936|144670464|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Chi-squared|Chi-squared test from Crosstabs analysis was implemented between two treatment groups in each time frame.||||||<0.05
72571030|NCT00741936|144670465|SUPERIORITY_OR_OTHER|||||||0||95.0|||||simple percentage|||||||0
72571031|NCT00741936|144670466|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Chi-squared|||||||<0.05
72524811|NCT02148952|144579709|SUPERIORITY||Risk Ratio (RR)|8.2|||<|0.001|TWO_SIDED|95.0|2.5|27.5|||Chi-squared, Corrected|||Skin-to-skin care initiated at birth||27.5|2.5|<0.001
72406522|NCT02942017|144321622|SUPERIORITY||LS Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.119||0.8654|TWO_SIDED|95.0|-0.26|0.22|||MMRM|||Hypochondriasis, Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.22|-0.26|0.8654
72524812|NCT02148952|144579709|SUPERIORITY||Other|0.0||||0.01|TWO_SIDED||||||Chi-squared, Corrected||The relative risk could not be calculated owing to 100% or 0% values in one group.|Skin-to-skin care maintained for 1 hr||||0.01
72524813|NCT02148952|144579709|SUPERIORITY||Risk Ratio (RR)|7.9|||<|0.001|TWO_SIDED|95.0|3.7|16.7|||Chi-squared, Corrected|||Initiation of breast-feeding||16.7|3.7|<0.001
72524814|NCT02148952|144579709|SUPERIORITY||Other|0.0|||<|0.001|TWO_SIDED||||||Chi-squared, Corrected||The relative risk could not be calculated owing to 100% or 0% values in one group.|Checklist use||||<0.001
72524815|NCT02148952|144579710|SUPERIORITY||Other|0.0|||<|0.001|TWO_SIDED||||||Chi-squared, Corrected||The relative risk could not be calculated owing to 100% or 0% values in one group.|Maternal temperature taken||||<0.001
72524816|NCT02148952|144579710|SUPERIORITY||Risk Ratio (RR)|12.7|||<|0.001|TWO_SIDED|95.0|4.7|34.3|||Chi-squared, Corrected|||Maternal blood pressure taken||34.3|4.7|<0.001
72524817|NCT02148952|144579710|SUPERIORITY||Risk Ratio (RR)|1.1||||0.95|TWO_SIDED|95.0|0.2|6.6|||Chi-squared, Corrected|||Mother given magnesium sulfate||6.6|0.2|0.95
72524818|NCT00085644|144579722|SUPERIORITY_OR_OTHER||Risk Difference (RD)|37.6|||<|0.001||95.0|27.4|47.8|||Chi-squared||Risk difference is measured as a percentage.|ASAS 20 response rates of the adalimumab group were compared with the placebo group using Pearson's Chi-square test. The counts and percentages were calculated for total sample and by therapy group. Statistical tests were 2-sided. For the statistical analysis, subjects with missing data before Week 12 were considered as nonresponders. The comparisons were performed at an alpha level = 0.05.||47.8|27.4|< 0.001
72524819|NCT00085644|144579723|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|0.3||0.985||95.0|||||ANCOVA|||||||0.985
72524820|NCT01836029|144579790|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.99||||0.266|ONE_SIDED|90.0||1.22||The 1-sided p-value based on a log-rank test stratified by randomization stratification factors.|Log Rank|||||1.22||0.266
72524821|NCT01836029|144579792|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.95||||0.399|ONE_SIDED|90.0||1.22||The 1-sided p-value based on a log-rank test stratified by randomization stratification factors.|Log Rank|||||1.22||0.399
72524822|NCT01836029|144579793|SUPERIORITY_OR_OTHER_LEGACY|||||||0.536||||||p-values are from Cochran-Mantel-Haenszel tests controlling for randomization stratification factors and comparing tumor response rates between the treatment groups.|Cochran-Mantel-Haenszel|||||||0.536
72524823|NCT01307046|144579880|SUPERIORITY_OR_OTHER_LEGACY||Difference in least square means|-5.1|||<|0.001|TWO_SIDED|95.0|-6.8|-3.4|||constrained longitudinal data analysis|||||-3.4|-6.8|<.001
72524824|NCT01307046|144579881|SUPERIORITY_OR_OTHER_LEGACY||Difference in least square means|-9.2|||<|0.001|TWO_SIDED|95.0|-11.9|-6.5|||constrained longitudinal data analysis|||||-6.5|-11.9|<.001
72524825|NCT02574520|144579883|SUPERIORITY|Primary|Mean Difference (Final Values)|-0.37|STANDARD_ERROR_OF_MEAN|0.24||0.124|TWO_SIDED|95.0|-0.84|0.1|||ANOVA|Mixed model with repeated measures (MMRM) for scheduled pain measurements was estimated with time as a repeating factor within subject.|Least squares mean from the MMRM described in the Statistical Test of Hypothesis.|Pain Intensity on Movement 0-48 hr||0.10|-0.84|0.124
72524826|NCT04960202|144580069|SUPERIORITY||Percentage difference|-6.137|STANDARD_ERROR_OF_MEAN|1.057|<|0.0001|TWO_SIDED|95.0|-8.208|-4.066|||Normal approximation|||The difference of the percentage in the 2 treatment groups and its 95% confidence interval, and p-value based on Normal approximation of the data are presented.||-4.066|-8.208|<0.0001
72524827|NCT04960202|144580072|SUPERIORITY||Percentage difference|-5.638|STANDARD_ERROR_OF_MEAN|0.852|<|0.0001|TWO_SIDED|95.0|-7.308|-3.967|||Normal approximation|||The difference of the percentage in the 2 treatment groups and its 95% confidence interval, and p-value based on Normal approximation of the data are presented.||-3.967|-7.308|<0.0001
72524828|NCT04960202|144580073|SUPERIORITY||Hazard Ratio (HR)|1.294||||0.0003|TWO_SIDED|95.0|1.136|1.476|||Cox Proportional Hazard Model|||Analysis of treatment effect on time to sustained alleviation is based on Cox proportional hazard (PH) model with treatment and geographic region effects as independent variables, and baseline SARS-CoV-2 serology status and baseline viral load (\<4 logarithm to base 10 \[log10\] copies/milliliter \[mL\], \>=4 log10 copies/mL) as covariates.||1.476|1.136|0.0003
72524829|NCT04960202|144580074|SUPERIORITY||Hazard Ratio (HR)|1.266|||<|0.0001|TWO_SIDED|95.0|1.134|1.412|||Cox Proportional Hazard Model|||Analysis of treatment effect on time to sustained alleviation is based on Cox PH model with treatment and geographic region effects as independent variables, and symptom onset duration (\<=3, \>3), baseline SARS-CoV-2 serology status and baseline viral load (\<4 log10 copies/mL, \>=4 log10 copies/mL) as covariates.||1.412|1.134|<0.0001
72524830|NCT04960202|144580075|SUPERIORITY||Hazard Ratio (HR)|1.258|||<|0.0001|TWO_SIDED|95.0|1.131|1.4|||Cox Proportional Hazard Model|||Analysis of treatment effect on time to sustained alleviation is based on Cox PH model with treatment and geographic region effects as independent variables, and symptom onset duration (\<=3, \>3), COVID-19 mAb treatment (Yes/No), baseline SARS-CoV-2 serology status and baseline viral load (\<4 log10 copies/mL, \>=4 log10 copies/mL) as covariates.||1.400|1.131|<0.0001
72524831|NCT04960202|144580076|SUPERIORITY||Odds Ratio (OR)|0.871||||0.3473|TWO_SIDED|95.0|0.652|1.162|||Regression, Logistic|||Odds ratio, 95% CI and p-value were computed from a logistic regression model including main effects of treatment, geographic region, baseline SARS-CoV-2 serology status and baseline viral load (\< 4 log10 copies/mL, \>= 4 log10 copies/mL).||1.162|0.652|0.3473
72524832|NCT04960202|144580077|SUPERIORITY||Odds Ratio (OR)|0.936||||0.5762|TWO_SIDED|95.0|0.74|1.182|||Regression, Logistic|||Odds ratio, 95% CI and p-value were computed from a logistic regression model including main effects of treatment, geographic region, symptom onset duration (\<=3, \>3), baseline SARS-CoV-2 serology status and baseline viral load (\< 4 log10 copies/mL, \>= 4 log10 copies/mL).||1.182|0.740|0.5762
72524833|NCT04960202|144580078|SUPERIORITY||Odds Ratio (OR)|0.969||||0.7807|TWO_SIDED|95.0|0.773|1.213|||Regression, Logistic|||Odds ratio, 95% CI and p-value were computed from a logistic regression model including main effects of treatment, geographic region, symptom onset duration (\<=3, \>3), COVID-19 mAb treatment (Yes/No),baseline SARS-CoV-2 serology status and baseline viral load (\< 4 log10 copies/mL, \>= 4 log10 copies/mL).||1.213|0.773|0.7807
72524834|NCT04960202|144580079|SUPERIORITY||Hazard Ratio (HR)|1.219||||0.0053|TWO_SIDED|95.0|1.061|1.401|||Cox Proportional Hazard Model|||Analysis of treatment effect on time to sustained resolution is based on Cox PH model with treatment and geographic region effects as independent variables, and baseline SARS-CoV-2 serology status and baseline viral load (\<4 log10 copies/mL, \>=4 log10 copies/mL) as covariates.||1.401|1.061|0.0053
72524835|NCT04960202|144580080|SUPERIORITY||Hazard Ratio (HR)|1.2||||0.0022|TWO_SIDED|95.0|1.068|1.348|||Cox Proportional Hazard Model|||Analysis of treatment effect on time to sustained resolution is based on Cox PH model with treatment and geographic region effects as independent variables, and symptom onset duration (\<=3, \>3), baseline SARS-CoV-2 serology status and baseline viral load (\<4 log10 copies/mL, \>=4 log10 copies/mL) as covariates.||1.348|1.068|0.0022
72524836|NCT04960202|144580081|SUPERIORITY||Hazard Ratio (HR)|1.194||||0.0021|TWO_SIDED|95.0|1.066|1.337|||Cox Proportional Hazard Model|||Analysis of treatment effect on time to sustained resolution is based on Cox PH model with treatment and geographic region effects as independent variables, and symptom onset duration (\<=3, \>3), COVID-19 mAb treatment (Yes/No), baseline SARS-CoV-2 serology status and baseline viral load (\<4 log10 copies/mL, \>=4 log10 copies/mL) as covariates.||1.337|1.066|0.0021
72524837|NCT04960202|144580088|SUPERIORITY||Odds Ratio (OR)|1.088||||0.5293|TWO_SIDED|95.0|0.836|1.416|||Regression, Logistic|||Odds ratio, 95% CI and p-value were computed from a logistic regression model including main effects of treatment, geographic region, baseline SARS-CoV-2 serology status and baseline viral load (\< 4 log10 copies/mL, \>= 4 log10 copies/mL).||1.416|0.836|0.5293
72571032|NCT00741936|144670467|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Paired-samples t-test|Paired-Samples T Test was implemented between pre-treatment (Wk2) and post-treatment (Wk10) of each treatment group.||||||<0.05
72524838|NCT04960202|144580089|SUPERIORITY||Odds Ratio (OR)|1.053||||0.6379|TWO_SIDED|95.0|0.85|1.303|||Regression, Logistic|||Odds ratio, 95% CI and p-value were computed from a logistic regression model including main effects of treatment, geographic region, symptom onset duration (\<=3, \>3), baseline SARS-CoV-2 serology status and baseline viral load (\< 4 log10 copies/mL, \>= 4 log10 copies/mL).||1.303|0.850|0.6379
72524839|NCT04960202|144580090|SUPERIORITY||Odds Ratio (OR)|1.046||||0.676|TWO_SIDED|95.0|0.848|1.29|||Regression, Logistic|||Odds ratio, 95% CI and p-value were computed from a logistic regression model including main effects of treatment, geographic region, symptom onset duration (\<=3, \>3), COVID-19 mAb treatment (Yes/No), baseline SARS-CoV-2 serology status and baseline viral load (\< 4 log10 copies/mL, \>= 4 log10 copies/mL).||1.290|0.848|0.6760
72524840|NCT04960202|144580091|SUPERIORITY||Odds Ratio (OR)|19.4||||0.1997||95.0|7.788|48.328|||Breslow-Day test||Odds ratio for Day 5 vs Day 1: PF-07321332 300 mg + Ritonavir 100 mg|||48.328|7.788|0.1997
72524841|NCT04960202|144580091|OTHER||Odds Ratio (OR)|8.948|||||TWO_SIDED|95.0|4.159|19.253|||Breslow-Day test||Odds ratio for Day 5 vs Day 1: Placebo|||19.253|4.159|
72571033|NCT00741936|144670468|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Paired-Samples T Test|Paired-Samples T Test was implemented between pre-treatment (Wk2) and post-treatment (Wk10) of each treatment group.||||||<0.05
72571034|NCT00741936|144670469|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Paired-Samples T Test|Paired-Samples T Test was implemented between pre-treatment (Wk2) and post-treatment (Wk10) of each treatment group.||||||<0.05
72571035|NCT00741936|144670470|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Paired-Samples T Test|Paired-Samples T Test was implemented between pre-treatment (Wk2) and post-treatment (Wk10) of each treatment group.||||||<0.05
72406523|NCT02942017|144321622|SUPERIORITY||LS Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.14||0.2101|TWO_SIDED|95.0|-0.48|0.11|||MMRM|||Hypochondriasis, Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.11|-0.48|0.2101
72524842|NCT04960202|144580092|SUPERIORITY||Odds Ratio (OR)|20.875||||0.281|TWO_SIDED|95.0|10.097|43.156|||Breslow-Day test||Odds ratio for Day 5 vs Day 1: PF-07321332 300 mg + Ritonavir 100 mg|||43.156|10.097|0.2810
72524843|NCT04960202|144580092|SUPERIORITY||Odds Ratio (OR)|12.452|||||TWO_SIDED|95.0|6.823|22.725|||Breslow Day test||Odds ratio for Day 5 vs Day 1: Placebo|||22.725|6.823|
72571036|NCT01941940|144670474|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Rank Sum and Signed Rank Tests|||Analysis for change from baseline to Week 24 was performed using Wilcoxon Rank Sum and Signed Rank Tests for dependent sample.||||<0.0001
72571037|NCT01941940|144670480|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Rank Sum and Signed Rank Tests|||Analysis for change from baseline to Week 2 was performed using Wilcoxon Rank Sum and Signed Rank Tests for dependent sample.||||<0.0001
72571038|NCT01941940|144670482|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Rank Sum and Signed Rank Tests|||Analysis for change from baseline to Week 2 was performed using Wilcoxon Rank Sum and Signed Rank Tests for dependent sample.||||<0.0001
72524844|NCT04960202|144580093|SUPERIORITY||Odds Ratio (OR)|21.119||||0.2226|TWO_SIDED|95.0|10.412|42.837|||Breslow-Day test||Odds ratio for Day 5 vs Day 1: PF-07321332 300 mg + Ritonavir 100 mg|||42.837|10.412|0.2226
72524845|NCT04960202|144580093|SUPERIORITY||Odds Ratio (OR)|12.036||||0.2342|TWO_SIDED|95.0|6.808|21.28|||Breslow-Day test||Odds ratio for Day 5 vs Day 1: Placebo|||21.280|6.808|0.2342
72524846|NCT03774875|144580116|SUPERIORITY||Adjusted Difference in Response Rates|31.9|STANDARD_ERROR_OF_MEAN|6.78|<|0.0001|TWO_SIDED|95.0|18.6|45.2|||Cochran-Mantel-Haenszel|The CMH (Cochran-Mantel-Haenszel) test adjusting for the stratification of the 5 difficult to treat manifestation types at randomization.|Adjusted difference (apremilast - placebo) in response rates calculated using the weighted average of the treatment differences across the strata with the CMH weights.|||45.2|18.6|<0.0001
72524847|NCT03774875|144580117|SUPERIORITY||Least Squares (LS) Mean Difference|-5.3|STANDARD_ERROR_OF_MEAN|0.95|<|0.0001|TWO_SIDED|95.0|-7.15|-3.43|||ANCOVA|ANCOVA model with treatment arm and stratification factor as independent variables and baseline value as a covariate.|Difference in LS Means = Apremilast - Placebo|||-3.43|-7.15|<0.0001
72524848|NCT03774875|144580118|SUPERIORITY||LS Mean Difference|-38.4|STANDARD_ERROR_OF_MEAN|14.12||0.0085|TWO_SIDED|95.0|-66.58|-10.14|||ANCOVA|ANCOVA model with treatment arm and stratification factor as independent variables and the baseline value as a covariate variable.|LS Mean Difference = Apremilast - Placebo|||-10.14|-66.58|0.0085
72524849|NCT03774875|144580119|SUPERIORITY||LS Mean Difference|-1.6|STANDARD_ERROR_OF_MEAN|0.38|<|0.0001|TWO_SIDED|95.0|-2.34|-0.86|||ANCOVA|ANCOVA model with treatment arm and stratification factor as independent variables and the baseline value as a covariate.|LS Mean Difference = Apremilast - Placebo|||-0.86|-2.34|<0.0001
72524850|NCT03774875|144580120|SUPERIORITY||LS Mean Difference|-16.1|STANDARD_ERROR_OF_MEAN|4.31||0.0003|TWO_SIDED|95.0|-24.63|-7.6|||ANCOVA|ANCOVA model with treatment arm and stratification factor as independent variables and the baseline value as a covariate.|LS Mean Difference = Apremilast - Placebo|||-7.60|-24.63|0.0003
72524851|NCT03774875|144580121|SUPERIORITY||Adjusted Difference in Response Rates|13.5|STANDARD_ERROR_OF_MEAN|6.3||0.0328|TWO_SIDED|95.0|1.1|25.8|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification of the 5 difficult to treat manifestation types at randomization.|The adjusted difference in response rates (Apremilast - Placebo) using the weighted average of the treatment differences across the strata with the CMH weights.|||25.8|1.1|0.0328
72524852|NCT03774875|144580122|SUPERIORITY||Adjusted Difference in Response Rates|37.0|STANDARD_ERROR_OF_MEAN|6.58|<|0.0001|TWO_SIDED|95.0|24.1|49.9|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusting for the stratification of the 5 difficult to treat manifestation types at randomization.|Adjusted difference (Apremilast - Placebo) in response rates using the weighted average of the treatment differences across the strata with the CMH weights.|||49.9|24.1|<0.0001
72524853|NCT03774875|144580123|SUPERIORITY||LS Mean Difference|14.9|STANDARD_ERROR_OF_MEAN|18.55||0.4216|TWO_SIDED|95.0|-21.62|51.48|||ANCOVA|ANCOVA model with treatment arm and stratification factor as independent variables and the baseline value as a covariate.|LS Mean Difference = Apremilast - Placebo|||51.48|-21.62|0.4216
72524854|NCT03774875|144580124|SUPERIORITY||LS Mean Difference|-148.024|STANDARD_ERROR_OF_MEAN|103.9525||0.1559|TWO_SIDED|95.0|-352.8793|56.8304|||ANCOVA|ANCOVA model with treatment arm and stratification factor as independent variables and the baseline value as a covariate.|LS Mean Difference = Apremilast - Placebo|||56.8304|-352.8793|0.1559
72524855|NCT03774875|144580125|SUPERIORITY||LS Mean Difference|3.1|STANDARD_ERROR_OF_MEAN|2.82||0.2667|TWO_SIDED|95.0|-2.43|8.73|||ANCOVA|ANCOVA model with treatment arm and stratification factor as independent variables and the baseline value as a covariate.|LS Mean Difference = Apremilast - Placebo|||8.73|-2.43|0.2667
72524856|NCT03774875|144580126|SUPERIORITY||LS Mean Difference|-2.5|STANDARD_ERROR_OF_MEAN|4.23||0.562|TWO_SIDED|95.0|-10.83|5.91|||ANCOVA|ANCOVA model with treatment arm and stratification factor as independent variables and the baseline value as a covariate.|LS Mean Difference = Apremilast - Placebo|||5.91|-10.83|0.5620
72524857|NCT03774875|144580127|SUPERIORITY||LS Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|4.81||0.8927|TWO_SIDED|95.0|-10.16|8.86|||ANCOVA|ANCOVA model with treatment arm and stratification factor as independent variables and the baseline value as a covariate.|LS Mean Difference = Apremilast - Placebo|||8.86|-10.16|0.8927
72524858|NCT03774875|144580128|SUPERIORITY||LS Mean Difference|-7.8|STANDARD_ERROR_OF_MEAN|4.09||0.0572|TWO_SIDED|95.0|-15.9|0.24|||ANCOVA|ANCOVA model with treatment arm and stratification factor as independent variables and the baseline value as a covariate.|LS Mean Difference = Apremilast - Placebo|||0.24|-15.90|0.0572
72524859|NCT05706623|144580154|OTHER|Analysis of variance model|Geometric least squares (LS) mean ratio|0.8354|||||TWO_SIDED|90.0|0.5216|1.338||||||Moderate Hepatic Impairment Group (test) versus Normal Hepatic Function Group (reference). The analysis was performed on natural log (ln) transformed parameters using an analysis of variance model with the hepatic function group as a fixed effect.||1.338|0.5216|
72524860|NCT05706623|144580156|OTHER|Analysis of variance model|Geometric LS Mean Ratio|0.9356|||||TWO_SIDED|90.0|0.5889|1.4864||||||Moderate Hepatic Impairment Group (test) versus Normal Hepatic Function Group (reference). The analysis was performed on ln transformed parameters using an analysis of variance model with the hepatic function group as a fixed effect.||1.4864|0.5889|
72524861|NCT03233308|144580166|OTHER|||||||0.001|||||||t-test, 1 sided|||Mean Change from Baseline||||0.0010
72524862|NCT03233308|144580167|OTHER|||||||0.0003|||||||t-test, 1 sided|||Mean change from baseline (percent difference from baseline)||||0.0003
72524863|NCT03233308|144580168|OTHER|||||||0.0687|||||||t-test, 1 sided|||Mean change from baseline -EVP||||0.0687
72524864|NCT03233308|144580168|OTHER||||||<|0.0001|||||||t-test, 1 sided|||Mean change from baseline -IOP||||<0.0001
72524865|NCT03233308|144580169|OTHER|||||||0.0087|||||||t-test, 1 sided|||Mean change from baseline (percent difference from baseline) -EVP||||0.0087
72524866|NCT03233308|144580169|OTHER||||||<|0.0001|||||||t-test, 1 sided|||Mean change from baseline (percent difference from baseline)- IOP||||<0.0001
72524867|NCT00576147|144580170|SUPERIORITY_OR_OTHER||Percent Sensitivity|88.0|||||TWO_SIDED|95.0|75.0|95.0||||||||95.0|75.0|
72571039|NCT01941940|144670482|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Rank Sum and Signed Rank Tests|||Analysis for change from baseline to Week 24 was performed using Wilcoxon Rank Sum and Signed Rank Tests for dependent sample.||||<0.0001
72571040|NCT01941940|144670482|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Rank Sum and Signed Rank Tests|||Analysis for change from baseline to Week 52 was performed using Wilcoxon Rank Sum and Signed Rank Tests for dependent sample.||||<0.0001
72406524|NCT02942017|144321622|SUPERIORITY||LS Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.126||0.7128|TWO_SIDED|95.0|-0.3|0.21|||MMRM|||Hypochondriasis, Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.21|-0.30|0.7128
72406525|NCT02942017|144321622|SUPERIORITY||LS Mean Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.09||0.3297|TWO_SIDED|95.0|-0.27|0.09|||MMRM|||Hypochondriasis, Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.09|-0.27|0.3297
72406526|NCT02942017|144321622|SUPERIORITY||LS Mean Difference|0.05|STANDARD_ERROR_OF_MEAN|0.069||0.4493|TWO_SIDED|95.0|-0.08|0.19|||MMRM|||Loss of weight, Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.19|-0.08|0.4493
72524868|NCT00576147|144580170|SUPERIORITY_OR_OTHER||Percent Specificity|90.7|||||TWO_SIDED|95.0|86.4|93.7||||||||93.7|86.4|
72524869|NCT02219516|144580180|NON_INFERIORITY_OR_EQUIVALENCE|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|153.0|||||TWO_SIDED|90.0|115.0|203.0|||Fixed Effects Model|Treatment as a fixed effect was used to analyze the natural log-transformed PK parameters and GLSMRs are back-transformed to the original scale.||||203|115|
72524870|NCT02219516|144580180|NON_INFERIORITY_OR_EQUIVALENCE|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|173.0|||||TWO_SIDED|90.0|131.0|230.0|||Fixed Effects Model|Treatment as a fixed effect was used to analyze the natural log-transformed PK parameters and GLSMRs are back-transformed to the original scale.||||230|131|
72524871|NCT02219516|144580180|NON_INFERIORITY_OR_EQUIVALENCE|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|228.0|||||TWO_SIDED|90.0|155.0|336.0|||Fixed Effects Model|Treatment as a fixed effect was used to analyze the natural log-transformed PK parameters and GLSMRs are back-transformed to the original scale.||||336|155|
72524872|NCT02219516|144580182|NON_INFERIORITY_OR_EQUIVALENCE|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|131.0|||||TWO_SIDED|90.0|98.6|174.0|||Fixed Effects Model|Treatment as a fixed effect was used to analyze the natural log-transformed PK parameters and GLSMRs are back-transformed to the original scale.||||174|98.6|
72524873|NCT02219516|144580182|NON_INFERIORITY_OR_EQUIVALENCE|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|222.0|||||TWO_SIDED|90.0|171.0|287.0|||Fixed Effects Model|Treatment as a fixed effect was used to analyze the natural log-transformed PK parameters and GLSMRs are back-transformed to the original scale.||||287|171|
72524874|NCT02219516|144580182|NON_INFERIORITY_OR_EQUIVALENCE|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|211.0|||||TWO_SIDED|90.0|139.0|319.0|||Fixed Effects Model|Treatment as a fixed effect was used to analyze the natural log-transformed PK parameters and GLSMRs are back-transformed to the original scale.||||319|139|
72524875|NCT02219516|144580183|NON_INFERIORITY_OR_EQUIVALENCE|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|124.0|||||TWO_SIDED|90.0|88.8|173.0|||Fixed Effects Model|Treatment as a fixed effect was used to analyze the natural log-transformed PK parameters and GLSMRs are back-transformed to the original scale.||||173|88.8|
72524876|NCT02219516|144580183|NON_INFERIORITY_OR_EQUIVALENCE|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|248.0|||||TWO_SIDED|90.0|168.0|366.0|||Fixed Effects Model|Treatment as a fixed effect was used to analyze the natural log-transformed PK parameters and GLSMRs are back-transformed to the original scale.||||366|168|
72524877|NCT02219516|144580183|NON_INFERIORITY_OR_EQUIVALENCE|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|230.0|||||TWO_SIDED|90.0|146.0|363.0|||Fixed Effects Model|Treatment as a fixed effect was used to analyze the natural log-transformed PK parameters and GLSMRs are back-transformed to the original scale.||||363|146|
72524878|NCT02219516|144580185|NON_INFERIORITY_OR_EQUIVALENCE|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|76.0|||||TWO_SIDED|90.0|57.1|101.0|||Fixed Effects Model|Treatment as a fixed effect was used to analyze the natural log-transformed PK parameters and GLSMRs are back-transformed to the original scale.||||101|57.1|
72524879|NCT02219516|144580185|NON_INFERIORITY_OR_EQUIVALENCE|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|45.1|||||TWO_SIDED|90.0|34.9|58.3|||Fixed Effects Model|Treatment as a fixed effect was used to analyze the natural log-transformed PK parameters and GLSMRs are back-transformed to the original scale.||||58.3|34.9|
72571041|NCT01941940|144670483|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Rank Sum and Signed Rank Tests|||Analysis for change from baseline to Week 2 was performed using Wilcoxon Rank Sum and Signed Rank Tests for dependent sample.||||<0.0001
72524880|NCT02219516|144580185|NON_INFERIORITY_OR_EQUIVALENCE|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|47.8|||||TWO_SIDED|90.0|31.5|72.5|||Fixed Effects Model|Treatment as a fixed effect was used to analyze the natural log-transformed PK parameters and GLSMRs are back-transformed to the original scale.||||72.5|31.5|
72524881|NCT02219516|144580186|NON_INFERIORITY_OR_EQUIVALENCE|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|80.8|||||TWO_SIDED|90.0|57.9|113.0|||Fixed Effects Model|Treatment as a fixed effect was used to analyze the natural log-transformed PK parameters and GLSMRs are back-transformed to the original scale.||||113|57.9|
72406527|NCT02942017|144321622|SUPERIORITY||LS Mean Difference|0.15|STANDARD_ERROR_OF_MEAN|0.081||0.0717|TWO_SIDED|95.0|-0.01|0.31|||MMRM|||Loss of weight, Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.31|-0.01|0.0717
72406528|NCT02942017|144321622|SUPERIORITY||LS Mean Difference|0.11|STANDARD_ERROR_OF_MEAN|0.066||0.1054|TWO_SIDED|95.0|-0.02|0.24|||MMRM|||Loss of Weight, Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.24|-0.02|0.1054
72406529|NCT02942017|144321622|SUPERIORITY||LS Mean Difference|0.18|STANDARD_ERROR_OF_MEAN|0.088||0.0408|TWO_SIDED|95.0|0.01|0.36|||MMRM|||Loss of Weight, Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.36|0.01|0.0408
72406530|NCT02942017|144321622|SUPERIORITY||LS Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|0.088||0.0233|TWO_SIDED|95.0|0.03|0.38|||MMRM|||Loss of Weight, Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.38|0.03|0.0233
72406531|NCT02942017|144321622|SUPERIORITY||LS Mean Difference|0.08|STANDARD_ERROR_OF_MEAN|0.088||0.361|TWO_SIDED|95.0|-0.09|0.26|||MMRM|||Loss of Weight, Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.26|-0.09|0.3610
72406532|NCT02942017|144321622|SUPERIORITY||LS Mean Difference|0.12|STANDARD_ERROR_OF_MEAN|0.1||0.2358|TWO_SIDED|95.0|-0.08|0.32|||MMRM|||Loss of Weight, Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.32|-0.08|0.2358
72406533|NCT02942017|144321622|SUPERIORITY||LS Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.085||0.9492|TWO_SIDED|95.0|-0.16|0.17|||MMRM|||Loss of Weight, Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.17|-0.16|0.9492
72406534|NCT02942017|144321622|SUPERIORITY||LS Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.102||0.4352|TWO_SIDED|95.0|-0.28|0.12|||MMRM|||Loss of Weight, Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.12|-0.28|0.4352
72406535|NCT02942017|144321622|SUPERIORITY||LS Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|0.125||0.1176|TWO_SIDED|95.0|-0.05|0.44|||MMRM|||Loss of Weight, Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.44|-0.05|0.1176
72406536|NCT02942017|144321622|SUPERIORITY||LS Mean Difference|0.05|STANDARD_ERROR_OF_MEAN|0.174||0.7812|TWO_SIDED|95.0|-0.3|0.4|||MMRM|||Loss of Weight, Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.40|-0.30|0.7812
72406537|NCT02942017|144321622|SUPERIORITY||LS Mean Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.182||0.5085|TWO_SIDED|95.0|-0.48|0.24|||MMRM|||Loss of Weight, Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.24|-0.48|0.5085
72524882|NCT02219516|144580186|NON_INFERIORITY_OR_EQUIVALENCE|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|40.3|||||TWO_SIDED|90.0|27.3|59.5|||Fixed Effects Model|Treatment as a fixed effect was used to analyze the natural log-transformed PK parameters and GLSMRs are back-transformed to the original scale.||||59.5|27.3|
72406538|NCT02942017|144321622|SUPERIORITY||LS Mean Difference|0.03|STANDARD_ERROR_OF_MEAN|0.156||0.8274|TWO_SIDED|95.0|-0.28|0.34|||MMRM|||Loss of Weight, Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.34|-0.28|0.8274
72524883|NCT02219516|144580186|NON_INFERIORITY_OR_EQUIVALENCE|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|43.5|||||TWO_SIDED|90.0|27.5|68.7|||Fixed Effects Model|Treatment as a fixed effect was used to analyze the natural log-transformed PK parameters and GLSMRs are back-transformed to the original scale.||||68.7|27.5|
72524884|NCT02219516|144580187|NON_INFERIORITY_OR_EQUIVALENCE|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|95.4|||||TWO_SIDED|90.0|60.6|150.0|||Fixed Effects Model|Treatment as a fixed effect was used to analyze the natural log-transformed PK parameters and GLSMRs are back-transformed to the original scale.||||150|60.6|
72524885|NCT02219516|144580187|NON_INFERIORITY_OR_EQUIVALENCE|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|58.3|||||TWO_SIDED|90.0|30.2|113.0|||Fixed Effects Model|Treatment as a fixed effect was used to analyze the natural log-transformed PK parameters and GLSMRs are back-transformed to the original scale.||||113|30.2|
72524886|NCT02219516|144580187|NON_INFERIORITY_OR_EQUIVALENCE|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|21.2|||||TWO_SIDED|90.0|13.6|32.8|||Fixed Effects Model|Treatment as a fixed effect was used to analyze the natural log-transformed PK parameters and GLSMRs are back-transformed to the original scale.||||32.8|13.6|
72524887|NCT01933399|144580188|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.4||||0.01|TWO_SIDED|95.0|2.2|16.6|||ANCOVA||"Difference in mean change in scores from baseline to follow-up by treatment group with no adjusment for baseline.~a priori threshold determined to be .05. no adjustments for multiple comparisons."|ANCOVA Adjusted for baseline score||16.6|2.2|.01
72524888|NCT01933399|144580188|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.3||||0.16|TWO_SIDED|95.0|-2.0|12.6||a priori threshold determined to be .05. no adjustments for multiple comparisons.|ANCOVA|Adjustment for baseline.||||12.6|-2.0|.16
72524889|NCT01933399|144580189|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.4||||0.01|TWO_SIDED|95.0|-2.3|-0.4|||ANCOVA|||Adjusted for baseline.||-0.4|-2.3|0.01
72524890|NCT01933399|144580189|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0||||0.05|TWO_SIDED|95.0|-2.1|0.0|||ANCOVA|||Adjusted for baseline.||0|-2.1|.05
72524891|NCT00062647|144580191|NON_INFERIORITY_OR_EQUIVALENCE|No margin was justified owing to the exploratory nature of the investigation.|Risk Difference (RD)|1.0||||||95.0|-35.5|31.9|||the difference in the 2 eradication rate|Statistical testing was limited to interval estimation (95% CI) of the difference in the 2 eradication rates using the method of Agresti and Caffo.||||31.9|-35.5|
72524892|NCT05083949|144580204|EQUIVALENCE|Bioequivalence was concluded, if the confidence interval (CI) for the comparison of geometric least squares means ratio was included in the pre-defined equivalence range of 80.00% to 125.00%.|Ratio of GLSM (%)|99.57|STANDARD_DEVIATION|5.23||0.7792|TWO_SIDED|90.0|97.03|102.19|||ANOVA||"Ratio of Geometric Least Squares Means (GLSM) was calculated as: Fixed dose combination (treatment B)/ free dose combination (treatment A).~Standard deviation is actually intra-individual geometric coefficient of variation (gCV \[%\])."|The statistical model used for the analysis was an analysis of variance (ANOVA) on the logarithmic scale. That is, the PK endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model. This model included effects accounting for the following sources of variation: sequence, subjects within sequences, period and treatment. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||102.19|97.03|0.7792
72524893|NCT05083949|144580205|EQUIVALENCE|Bioequivalence was concluded, if the confidence interval (CI) for the comparison of geometric least squares means ratio was included in the pre-defined equivalence range of 80.00% to 125.00%.|Ratio of GLSM (%)|101.36|STANDARD_DEVIATION|10.18||0.6493|TWO_SIDED|90.0|96.39|106.59|||ANOVA||"Ratio of Geometric Least Squares Means (GLSM) was calculated as: Fixed dose combination (treatment B)/ free dose combination (treatment A).~Standard deviation is actually intra-individual geometric coefficient of variation (gCV \[%\])."|The statistical model used for the analysis was an analysis of variance (ANOVA) on the logarithmic scale. That is, the PK endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model. This model included effects accounting for the following sources of variation: sequence, subjects within sequences, period and treatment. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||106.59|96.39|0.6493
72524894|NCT05083949|144580206|EQUIVALENCE|Bioequivalence was concluded, if the confidence interval (CI) for the comparison of geometric least squares means ratio was included in the pre-defined equivalence range of 80.00% to 125.00%.|Ratio of GLSM (%)|101.63|STANDARD_DEVIATION|7.65||0.471|TWO_SIDED|90.0|97.85|105.55|||ANOVA||"Ratio of Geometric Least Squares Means (GLSM) was calculated as: Fixed dose combination (treatment B)/ free dose combination (treatment A).~Standard deviation is actually intra-individual geometric coefficient of variation (gCV \[%\])."|The statistical model used for the analysis of the was an analysis of variance (ANOVA) on the logarithmic scale. That is, the PK endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model. This model included effects accounting for the following sources of variation: sequence, subjects within sequences, period and treatment. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||105.55|97.85|0.4710
72571042|NCT01941940|144670483|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Rank Sum and Signed Rank Tests|||Analysis for change from baseline to Week 24 was performed using Wilcoxon Rank Sum and Signed Rank Tests for dependent sample.||||<0.0001
72571043|NCT01941940|144670483|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Rank Sum and Signed Rank Tests|||Analysis for change from baseline to Week 52 was performed using Wilcoxon Rank Sum and Signed Rank Tests for dependent sample.||||<0.0001
72571044|NCT01941940|144670486|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Rank Sum and Signed Rank Tests|||TJC-68: Analysis for change from baseline to Week 2 was performed using Wilcoxon Rank Sum and Signed Rank Tests for dependent sample.||||<0.0001
72524895|NCT05083949|144580207|EQUIVALENCE|Bioequivalence was concluded, if the confidence interval (CI) for the comparison of geometric least squares means ratio was included in the pre-defined equivalence range of 80.00% to 125.00%.|Ratio of GLSM (%)|98.11|STANDARD_DEVIATION|8.14||0.4251|TWO_SIDED|90.0|94.24|102.15|||ANOVA||"Ratio of Geometric Least Squares Means (GLSM) was calculated as: Fixed dose combination (treatment B)/ free dose combination (treatment A).~Standard deviation is actually intra-individual geometric coefficient of variation (gCV \[%\])."|The statistical model used for the analysis was an analysis of variance (ANOVA) on the logarithmic scale. That is, the PK endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model. This model included effects accounting for the following sources of variation: sequence, subjects within sequences, period and treatment. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||102.15|94.24|0.4251
72524896|NCT05083949|144580208|EQUIVALENCE|Bioequivalence was concluded, if the confidence interval (CI) for the comparison of geometric least squares means ratio was included in the pre-defined equivalence range of 80.00% to 125.00%.|Ratio of GLSM (%)|99.49|STANDARD_DEVIATION|5.25||0.7379|TWO_SIDED|90.0|96.93|102.11|||ANOVA||"Ratio of Geometric Least Squares Means (GLSM) was calculated as: Fixed dose combination (treatment B)/ free dose combination (treatment A).~Standard deviation is actually intra-individual geometric coefficient of variation (gCV \[%\])."|The statistical model used for the analysis was an analysis of variance (ANOVA) on the logarithmic scale. That is, the PK endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model. This model included effects accounting for the following sources of variation: sequence, subjects within sequences, period and treatment. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||102.11|96.93|0.7379
72524897|NCT05083949|144580209|EQUIVALENCE|Bioequivalence was concluded, if the confidence interval (CI) for the comparison of geometric least squares means ratio was included in the pre-defined equivalence range of 80.00% to 125.00%.|Ratio of GLSM (%)|101.24|STANDARD_DEVIATION|7.82||0.5895|TWO_SIDED|90.0|97.4|105.24|||ANOVA||"Ratio of Geometric Least Squares Means (GLSM) was calculated as: Fixed dose combination (treatment B)/ free dose combination (treatment A).~Standard deviation is actually intra-individual geometric coefficient of variation (gCV \[%\])."|The statistical model used for the analysis was an analysis of variance (ANOVA) on the logarithmic scale. That is, the PK endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model. This model included effects accounting for the following sources of variation: sequence, subjects within sequences, period and treatment. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||105.24|97.40|0.5895
72524898|NCT01678560|144580218|OTHER|Exact Fisher test was used on the collected information from the limited population|Fisher exact test statistic value|1.0|||<|0.01|TWO_SIDED|||||Hypothesis: Active continuous monitoring of PAP treatment in OSA will result in improved adherence at 90 days Exact Fisher test was used on the collected information from the limited population.|Fisher Exact|Exact Fisher test was used on the information from the limited population.||PAP devices delivery to the patients was outsourced by the institution eliminating the point of recruitment for the study at our department. The recruitment was halted and the study proceeded with the follow-up of already recruited patients. As a result of the limited recruitment, planned statistical data analysis was not performed on the primary outcomes due to the smaller then expected number of subjects (expected 110 subjects in the Usual arm and 110 subjects in the Wireless arm.|Exact Fisher test was used on the collected information from the limited population.|||<0.01
72524899|NCT01678560|144580219|OTHER|Exact Fisher test was used on the collected information from the limited population|Fisher exact test statistic value|1.0|||<|0.01|TWO_SIDED|||||"Hypothesis: Active continuous monitoring of PAP treatment in OSA (Wireless group) will result in improved adherence at 90 days compared to Usual Group.~Exact Fisher test was used on the collected information from the limited population."|Fisher Exact|Exact Fisher test was used on the information from the limited population||CPAP devices delivery to the patients was outsourced by the institution eliminating the point of recruitment for the study at our department The recruitment was halted and the study proceeded with the follow-up of already recruited patients. As a result of the limited recruitment, planned statistical data analysis was not performed on the primary outcomes due to the smaller then expected number of subjects (expected 110 subjects in the Usual arm and 110 subjects in the Wireless arm|Exact Fisher test was used on the collected information from the limited population|||<0.01
72524900|NCT01678560|144580220|OTHER|Exact Fisher test was used on the collected information from the limited population|Estimation Parameter Other[Fisher exact|1.0|||<|0.01|TWO_SIDED|||||Hypothesis - Number of patients effectively treated with the PAP will be higher in the Wireless Group compared to the Usual Group Exact Fisher test was used on the collected information from the limited population.|Fisher Exact|||CPAP devices delivery to the patients was outsourced by the institution eliminating the point of recruitment for the study at our department The recruitment was halted and the study proceeded with the follow-up of already recruited patients. As a result of the limited recruitment, planned statistical data analysis was not performed on the primary outcomes due to the smaller then expected number of subjects (expected 110 subjects in the Usual arm and 110 subjects in the Wireless arm.||||<0.01
72571045|NCT01941940|144670486|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Rank Sum and Signed Rank Tests|||TJC-68: Analysis for change from baseline to Week 24 was performed using Wilcoxon Rank Sum and Signed Rank Tests for dependent sample.||||<0.0001
72571046|NCT01941940|144670486|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Rank Sum and Signed Rank Tests|||TJC-68: Analysis for change from baseline to Week 52 was performed using Wilcoxon Rank Sum and Signed Rank Tests for dependent sample.||||<0.0001
72571047|NCT01941940|144670486|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Rank Sum and Signed Rank Tests|||TJC-28: Analysis for change from baseline to Week 2 was performed using Wilcoxon Rank Sum and Signed Rank Tests for dependent sample.||||<0.0001
72625233|NCT01098747|144780080|SUPERIORITY_OR_OTHER||LS mean difference|-0.58||||0.043|TWO_SIDED|95.0|-1.15|-0.02||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||6 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||-0.02|-1.15|0.043
72571048|NCT01941940|144670486|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Rank Sum and Signed Rank Tests|||TJC-28: Analysis for change from baseline to Week 24 was performed using Wilcoxon Rank Sum and Signed Rank Tests for dependent sample.||||<0.0001
72571049|NCT01941940|144670486|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Rank Sum and Signed Rank Tests|||TJC-28: Analysis for change from baseline to Week 52 was performed using Wilcoxon Rank Sum and Signed Rank Tests for dependent sample.||||<0.0001
72571050|NCT01941940|144670487|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Rank Sum and Signed Rank Tests|||SJC-66: Analysis for change from baseline to Week 2 was performed using Wilcoxon Rank Sum and Signed Rank Tests for dependent sample.||||<0.0001
72571051|NCT01941940|144670487|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Rank Sum and Signed Rank Tests|||SJC-66: Analysis for change from baseline to Week 24 was performed using Wilcoxon Rank Sum and Signed Rank Tests for dependent sample.||||<0.0001
72571052|NCT01941940|144670487|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Rank Sum and Signed Rank Tests|||SJC-66: Analysis for change from baseline to Week 52 was performed using Wilcoxon Rank Sum and Signed Rank Tests for dependent sample.||||<0.0001
72406539|NCT02942017|144321622|SUPERIORITY||LS Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.045||0.3675|TWO_SIDED|95.0|-0.13|0.05|||MMRM|||Insight, Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.05|-0.13|0.3675
72406540|NCT02942017|144321622|SUPERIORITY||LS Mean Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.045||0.1818|TWO_SIDED|95.0|-0.15|0.03|||MMRM|||Insight, Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.03|-0.15|0.1818
72524901|NCT01678560|144580221|OTHER|Exact Fisher test was used on the collected information from the limited population|Other[Fisher exact test statistic value]|0.0286|||<|0.01|TWO_SIDED|||||Hypothesis - PAP treatment Adherence in the first 3 months of treatment predicts the PAP treatment Adherence in the next 9 months of treatment Exact Fisher test was used on the collected information from the limited population|Fisher Exact||Exact Fisher test was used on the collected information from the limited population.|Exact Fisher test was used on the collected information from the limited population|Exact Fisher test was used on the collected information from the limited population.|||<0.01
72524902|NCT01678560|144580222|OTHER|Exact Fisher test was used on the collected information from the limited population|Exact Fisher test|0.0039|||<|0.01|TWO_SIDED|||||"Hypothesis: Patients with the higher AHI are more likely to become adherent to the PAP therapy.~Exact Fisher test was used on the collected information from the limited population"|Fisher Exact|Exact Fisher test was used on the collected information from the limited population||Exact Fisher test was used on the collected information from the limited population|Exact Fisher test was used on the collected information from the limited population|||<0.01
72524903|NCT00804986|144580247|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-0.47||||0.0109|TWO_SIDED|95.0|-0.83|-0.11||p-value represents change from baseline to Week 12 HbA1c for 0.5 mg treatment arm in comparison to placebo with values \<0.05 considered to be statistically significant.|Mixed Models Analysis|Mixed effects model: baseline HbA1c, metformin use, treatment, visit, treatment-by-visit interaction||||-0.11|-0.83|0.0109
72571053|NCT01941940|144670487|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Rank Sum and Signed Rank Tests|||SJC-28: Analysis for change from baseline to Week 2 was performed using Wilcoxon Rank Sum and Signed Rank Tests for dependent sample.||||<0.0001
72571054|NCT01941940|144670487|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Rank Sum and Signed Rank Tests|||SJC-28: Analysis for change from baseline to Week 24 was performed using Wilcoxon Rank Sum and Signed Rank Tests for dependent sample.||||<0.0001
72625234|NCT01098747|144780080|SUPERIORITY_OR_OTHER||LS mean difference|2.33|||<|0.001|TWO_SIDED|95.0|1.53|3.12||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||7 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||3.12|1.53|<0.001
72571055|NCT01941940|144670487|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Rank Sum and Signed Rank Tests|||SJC-28: Analysis for change from baseline to Week 52 was performed using Wilcoxon Rank Sum and Signed Rank Tests for dependent sample.||||<0.0001
72571056|NCT01941940|144670488|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||Analysis for association between DAS28-ESR and CDAI at Week 2||||<0.0001
72571057|NCT01941940|144670488|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||Analysis for association between DAS28-ESR and CDAI at Week 24||||<0.0001
72571058|NCT01941940|144670488|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||Analysis for association between DAS28-ESR and CDAI at Week 52||||<0.0001
72571059|NCT01941940|144670489|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||Analysis for association between DAS28-ESR and SDAI at Week 2||||<0.0001
72571060|NCT01941940|144670489|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||Analysis for association between DAS28-ESR and SDAI at Week 24||||<0.0001
72571061|NCT01941940|144670489|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||Analysis for association between DAS28-ESR and SDAI at Week 52||||<0.0001
72571062|NCT01941940|144670490|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||Analysis for association between CDAI and SDAI at Week 2||||<0.0001
72571063|NCT01941940|144670490|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||Analysis for association between CDAI and SDAI at Week 24||||<0.0001
72571064|NCT01941940|144670490|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||Analysis for association between CDAI and SDAI at Week 52||||<0.0001
72571065|NCT01941940|144670491|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||Analysis for association between DAS28-ESR and ACR20 at Week 2||||<0.0001
72571066|NCT01941940|144670491|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||Analysis for association between DAS28-ESR and ACR50 at Week 2||||<0.0001
72571067|NCT01941940|144670491|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||Analysis for association between DAS28-ESR and ACR70 at Week 2||||<0.0001
72571068|NCT01941940|144670491|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||Analysis for association between DAS28-ESR and ACR20 at Week 24||||<0.0001
72524904|NCT00804986|144580247|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-0.67||||0.0003|TWO_SIDED|95.0|-1.02|-0.31||p-value represents change from baseline to week 12 HbA1c for 2.0 mg treatment arm in comparison to placebo with values \<0.05 considered to be statistically significant.|Mixed Models Analysis|Mixed effects model: baseline HbA1c, metformin use, treatment, visit, treatment-by-visit interaction||||-0.31|-1.02|0.0003
72524905|NCT00804986|144580247|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-1.11|||<|0.0001|TWO_SIDED|95.0|-1.46|-0.76||p-value represents change from baseline to Week 12 HbA1c for 6.2 mg treatment arm in comparison to placebo with values \<0.05 considered to be statistically significant.|Mixed Models Analysis|Mixed effects model: baseline HbA1c, metformin use, treatment, visit, treatment-by-visit interaction||||-0.76|-1.46|<0.0001
72524906|NCT00804986|144580247|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-1.28|||<|0.0001|TWO_SIDED|95.0|-1.64|-0.93||p-value represents change from baseline to Week 12 HbA1c for 12.0 mg treatment arm in comparison to placebo with values \<0.05 considered to be statistically significant.|Mixed Models Analysis|Mixed effects model: baseline HbA1c, metformin use, treatment, visit, treatment-by-visit interaction||||-0.93|-1.64|<0.0001
72524907|NCT00804986|144580247|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-1.24|||<|0.0001|TWO_SIDED|95.0|-1.59|-0.88||p-value represents change from baseline to Week 12 HbA1c for 17.6 mg treatment arm in comparison to placebo with values \<0.05 considered to be statistically significant.|Mixed Models Analysis|Mixed effects model: baseline HbA1c, metformin use, treatment, visit, treatment-by-visit interaction||||-0.88|-1.59|<0.0001
72524908|NCT00804986|144580248|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|1.93||||0.655||95.0||||p-value represents change from baseline to Week 12 for hunger, 0.5 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||0.655
72524909|NCT00804986|144580248|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|3.36||||0.436||95.0||||p-value represents change from baseline to Week 12 for hunger, 2.0 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||0.436
72524910|NCT00804986|144580248|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|0.45||||0.914||95.0||||p-value represents change from baseline to Week 12 for hunger, 6.2 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||0.914
72524911|NCT00804986|144580248|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|3.3||||0.446||95.0||||p-value represents change from baseline to Week 12 for hunger, 12.0 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||0.446
72524912|NCT00804986|144580248|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|2.84||||0.508||95.0||||p-value represents change from baseline to Week 12 for hunger, 17.6 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||0.508
72524913|NCT00804986|144580248|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|2.89||||0.561||95.0||||p-value represents change from baseline to Week 12 for how full, 0.5 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||0.561
72524914|NCT00804986|144580248|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-7.4||||0.135||95.0||||p-value represents change from baseline to Week 12 for how full, 2.0 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||0.135
72524915|NCT00804986|144580248|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-4.45||||0.357||95.0||||p-value represents change from baseline to Week 12 for how full, 6.2 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||0.357
72524916|NCT00804986|144580248|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-8.05||||0.105||95.0||||p-value represents change from baseline to Week 12 for how full, 12.0 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||0.105
72524917|NCT00804986|144580248|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-6.02||||0.221||95.0||||p-value represents change from baseline to Week 12 for how full, 17.6 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||0.221
72524918|NCT00804986|144580251|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-4.54||||0.4848||95.0||||p-value represents change from baseline to Week 12 for fasting glucose, 0.5 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||0.4848
72524919|NCT00804986|144580251|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-19.48||||0.0029||95.0||||p-value represents change from baseline to Week 12 for fasting glucose, 2.0 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||0.0029
72524920|NCT00804986|144580251|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-32.52|||<|0.0001||95.0||||p-value represents change from baseline to Week 12 for fasting glucose, 6.2 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||<0.0001
72524921|NCT00804986|144580251|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-30.45|||<|0.0001||95.0||||p-value represents change from baseline to Week 12 for fasting glucose, 12.0 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||<0.0001
72524922|NCT00804986|144580251|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-35.25|||<|0.0001||95.0||||p-value represents change from baseline to Week 12 for fasting glucose, 17.6 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||<0.0001
72571069|NCT01941940|144670491|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||Analysis for association between DAS28-ESR and ACR50 at Week 24||||<0.0001
72571070|NCT01941940|144670491|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||Analysis for association between DAS28-ESR and ACR70 at Week 24||||<0.0001
72406541|NCT02942017|144321622|SUPERIORITY||LS Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.045||0.0826|TWO_SIDED|95.0|-0.17|0.01|||MMRM|||Insight, Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.01|-0.17|0.0826
72406542|NCT02942017|144321622|SUPERIORITY||LS Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.045||0.6436|TWO_SIDED|95.0|-0.11|0.07|||MMRM|||Insight, Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.07|-0.11|0.6436
72406543|NCT02942017|144321622|SUPERIORITY||LS Mean Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.045||0.1827|TWO_SIDED|95.0|-0.15|0.03|||MMRM|||Insight, Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.03|-0.15|0.1827
72406544|NCT02942017|144321622|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.045||0.9859|TWO_SIDED|95.0|-0.09|0.09|||MMRM|||Insight, Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.09|-0.09|0.9859
72406545|NCT02942017|144321622|SUPERIORITY||LS Mean Difference|0.02|STANDARD_ERROR_OF_MEAN|0.045||0.6672|TWO_SIDED|95.0|-0.07|0.11|||MMRM|||Insight, Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.11|-0.07|0.6672
72406546|NCT02942017|144321622|SUPERIORITY||LS Mean Difference|0.06|STANDARD_ERROR_OF_MEAN|0.046||0.2031|TWO_SIDED|95.0|-0.03|0.15|||MMRM|||Insight, Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.15|-0.03|0.2031
72406547|NCT02942017|144321622|SUPERIORITY||LS Mean Difference|0.02|STANDARD_ERROR_OF_MEAN|0.045||0.6664|TWO_SIDED|95.0|-0.07|0.11|||MMRM|||Insight, Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.11|-0.07|0.6664
72524923|NCT00804986|144580251|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-5.32||||0.6279||95.0||||p-value represents change from baseline to Week 12 for 2 hours post breakfast glucose, 0.5 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||0.6279
72524924|NCT00804986|144580251|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-29.72||||0.0072||95.0||||p-value represents change from baseline to Week 12 for 2 hours post breakfast glucose, 2.0 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||0.0072
72524925|NCT00804986|144580251|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-42.49|||<|0.0001||95.0||||p-value represents change from baseline to Week 12 for 2 hours post breakfast glucose, 6.2 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||<0.0001
72524926|NCT00804986|144580251|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-43.05||||0.0001||95.0||||p-value represents change from baseline to Week 12 for 2 hours post breakfast glucose, 12.0 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||0.0001
72524927|NCT00804986|144580251|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-51.38|||<|0.0001||95.0||||p-value represents change from baseline to Week 12 for 2 hours post breakfast glucose, 17.6 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||<0.0001
72524928|NCT00804986|144580251|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-20.21||||0.0335||95.0||||p-value represents change from baseline to Week 12 for prior to lunch glucose, 0.5 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||0.0335
72524929|NCT00804986|144580251|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-21.91||||0.0221||95.0||||p-value represents change from baseline to Week 12 for prior to lunch glucose, 2.0 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||0.0221
72524930|NCT00804986|144580251|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-39.41|||<|0.0001||95.0||||p-value represents change from baseline to Week 12 for prior to lunch glucose, 6.2 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||<0.0001
72524931|NCT00804986|144580251|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-36.07||||0.0002||95.0||||p-value represents change from baseline to Week 12 for prior to lunch glucose, 12.0 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||0.0002
72571071|NCT01941940|144670491|SUPERIORITY_OR_OTHER|||||||0.0004|||||||ANOVA|||Analysis for association between DAS28-ESR and ACR20 at Week 52||||0.0004
72406548|NCT02942017|144321622|SUPERIORITY||LS Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.045||0.3417|TWO_SIDED|95.0|-0.13|0.05|||MMRM|||Insight, Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.05|-0.13|0.3417
72524932|NCT00804986|144580251|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-40.36|||<|0.0001||95.0||||p-value represents change from baseline to Week 12 for prior to lunch glucose, 17.6 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||<0.0001
72524933|NCT00804986|144580251|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-6.41||||0.503||95.0||||p-value represents change from baseline to Week 12 for 2 hours post lunch glucose, 0.5 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||0.5030
72524934|NCT00804986|144580251|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-12.49||||0.1938||95.0||||p-value represents change from baseline to Week 12 for 2 hours post lunch glucose, 2.0 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||0.1938
72524935|NCT00804986|144580251|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-33.13||||0.0003||95.0||||p-value represents change from baseline to Week 12 for 2 hours post lunch glucose, 6.2 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||0.0003
72524936|NCT00804986|144580251|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-24.66||||0.0101||95.0||||p-value represents change from baseline to Week 12 for 2 hours post lunch glucose, 12.0 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||0.0101
72524937|NCT00804986|144580251|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-43.47|||<|0.0001||95.0||||p-value represents change from baseline to Week 12 for 2 hours post lunch glucose, 17.6 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||<0.0001
72524938|NCT00804986|144580251|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-24.69||||0.006||95.0||||p-value represents change from baseline to Week 12 for prior to dinner glucose, 0.5 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||0.0060
72524939|NCT00804986|144580251|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-34.26||||0.0002||95.0||||p-value represents change from baseline to Week 12 for prior to dinner glucose, 2.0 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||0.0002
72524940|NCT00804986|144580251|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-38.55|||<|0.0001||95.0||||p-value represents change from baseline to Week 12 for prior to dinner glucose, 6.2 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||<0.0001
72524941|NCT00804986|144580251|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-40.34|||<|0.0001||95.0||||p-value represents change from baseline to Week 12 for prior to dinner glucose, 12.0 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||<0.0001
72524942|NCT00804986|144580251|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-46.26|||<|0.0001||95.0||||p-value represents change from baseline to Week 12 for prior to dinner glucose, 17.6 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||<0.0001
72524943|NCT00804986|144580251|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-11.84||||0.2468||95.0||||p-value represents change from baseline to Week 12 for 2 hours post dinner glucose, 0.5 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||0.2468
72524944|NCT00804986|144580251|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-21.13||||0.0413||95.0||||p-value represents change from baseline to Week 12 for 2 hours post dinner glucose, 2.0 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, visit, treatment and visit by treatment interaction as fixed effects||||||0.0413
72524945|NCT00804986|144580251|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-35.19||||0.0004||95.0||||p-value represents change from baseline to Week 12 for 2 hours post dinner glucose, 6.2 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||0.0004
72524946|NCT00804986|144580251|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-29.59||||0.004||95.0||||p-value represents change from baseline to Week 12 for 2 hours post dinner glucose, 12.0 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||0.0040
72524947|NCT00804986|144580251|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-49.9|||<|0.0001||95.0||||p-value represents change from baseline to Week 12 for 2 hours post dinner glucose, 17.6 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||<0.0001
72524948|NCT00804986|144580251|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-24.02||||0.0199||95.0||||p-value represents change from baseline to Week 12 for prior to bed glucose, 0.5 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||0.0199
72524949|NCT00804986|144580251|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-35.77||||0.0008||95.0||||p-value represents change from baseline to Week 12 for prior to bed glucose, 2.0 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||0.0008
72524950|NCT00804986|144580251|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-38.17||||0.0001||95.0||||p-value represents change from baseline to Week 12 for prior to bed glucose, 6.2 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||0.0001
72524951|NCT00804986|144580251|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-40.74||||0.0001||95.0||||p-value represents change from baseline to Week 12 for prior to bed glucose, 12.0 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||0.0001
72524952|NCT00804986|144580251|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-53.16|||<|0.0001||95.0||||p-value represents change from baseline to Week 12 for prior to bed glucose, 17.6 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||<0.0001
72524953|NCT00804986|144580252|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-1131.85||||0.4193||95.0||||p-value represents change from baseline to Week 12 total glucose AUC for 0.5 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||0.4193
72524954|NCT00804986|144580252|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-1471.04||||0.3026||95.0||||p-value represents change from baseline to Week 12 total glucose AUC for 2.0 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||0.3026
72524955|NCT00804986|144580252|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-5547.95|||<|0.0001||95.0||||p-value represents change from baseline to Week 12 total glucose AUC for 6.2 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||<0.0001
72524956|NCT00804986|144580252|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-6116.19|||<|0.0001||95.0||||p-value represents change from baseline to Week 12 total glucose AUC for 12.0 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||<0.0001
72524957|NCT00804986|144580252|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-7786.69|||<|0.0001||95.0||||p-value represents change from baseline to Week 12 total glucose AUC for 17.6 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||<0.0001
72524958|NCT00804986|144580255|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|0.08||||0.693||95.0||||p-value represents change from baseline to Week 12 for fasting triglycerides, 0.5 mg treatment arm in comparison to placebo|ANCOVA|ANCOVA: baseline and treatment||||||0.693
72524959|NCT00804986|144580255|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|0.31||||0.104||95.0||||p-value represents change from baseline to Week 12 for fasting triglycerides, 2.0 mg treatment arm in comparison to placebo|ANCOVA|ANCOVA: baseline and treatment||||||0.104
72524960|NCT00804986|144580255|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-0.13||||0.506||95.0||||p-value represents change from baseline to Week 12 for fasting triglycerides, 6.2 mg treatment arm in comparison to placebo|ANCOVA|ANCOVA: baseline and treatment||||||0.506
72524961|NCT00804986|144580255|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-0.09||||0.648||95.0||||p-value represents change from baseline to Week 12 for fasting triglycerides, 12.0 mg treatment arm in comparison to placebo|ANCOVA|ANCOVA: baseline and treatment||||||0.648
72524962|NCT00804986|144580255|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-0.09||||0.647||95.0||||p-value represents change from baseline to Week 12 for fasting triglycerides, 17.6 mg treatment arm in comparison to placebo|ANCOVA|ANCOVA: baseline and treatment||||||0.647
72524963|NCT00804986|144580255|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|0.01||||0.781||95.0||||p-value represents change from baseline to Week 12 for fasting HDL, 0.5 mg treatment arm in comparison to placebo|ANCOVA|ANCOVA: baseline and treatment||||||0.781
72524964|NCT00804986|144580255|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-0.04||||0.401||95.0||||p-value represents change from baseline to Week 12 for fasting HDL, 2.0 mg treatment arm in comparison to placebo|ANCOVA|ANCOVA: baseline and treatment||||||0.401
72524965|NCT00804986|144580255|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-0.03||||0.464||95.0||||p-value represents change from baseline to Week 12 for fasting HDL, 6.2 mg treatment arm in comparison to placebo|ANCOVA|ANCOVA: baseline and treatment||||||0.464
72524966|NCT00804986|144580255|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-0.04||||0.42||95.0||||p-value represents change from baseline to Week 12 for fasting HDL, 12.0 mg treatment arm in comparison to placebo|ANCOVA|ANCOVA: baseline and treatment||||||0.420
72524967|NCT00804986|144580255|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|0.01||||0.762||95.0||||p-value represents change from baseline to Week 12 for fasting HDL, 17.6 mg treatment arm in comparison to placebo|ANCOVA|ANCOVA: baseline and treatment||||||0.762
72524968|NCT00804986|144580255|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-0.04||||0.738||95.0||||p-value represents change from baseline to Week 12 for fasting LDL, 0.5 mg treatment arm in comparison to placebo|ANCOVA|ANCOVA: baseline and treatment||||||0.738
72524969|NCT00804986|144580255|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-0.14||||0.277||95.0||||p-value represents change from baseline to Week 12 for fasting LDL, 2.0 mg treatment arm in comparison to placebo|ANCOVA|ANCOVA: baseline and treatment||||||0.277
72524970|NCT00804986|144580255|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-0.21||||0.094||95.0||||p-value represents change from baseline to Week 12 for fasting LDL, 6.2 mg treatment arm in comparison to placebo|ANCOVA|ANCOVA: baseline and treatment||||||0.094
72524971|NCT00804986|144580255|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-0.04||||0.792||95.0||||p-value represents change from baseline to Week 12 for fasting LDL, 12.0 mg treatment arm in comparison to placebo|ANCOVA|ANCOVA: baseline and treatment||||||0.792
72406549|NCT02942017|144321622|SUPERIORITY||LS Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.051||0.6622|TWO_SIDED|95.0|-0.12|0.08|||MMRM|||Insight, Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.08|-0.12|0.6622
72406550|NCT02942017|144321622|SUPERIORITY||LS Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.051||0.9087|TWO_SIDED|95.0|-0.11|0.09|||MMRM|||Insight, Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.09|-0.11|0.9087
72406551|NCT02942017|144321622|SUPERIORITY||LS Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.046||0.8263|TWO_SIDED|95.0|-0.08|0.1|||MMRM|||Insight, Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.10|-0.08|0.8263
72406552|NCT02942017|144321623|SUPERIORITY||LS mean difference|-4.86|STANDARD_ERROR_OF_MEAN|1.612||0.0033|TWO_SIDED|95.0|-8.06|-1.66|||MMRM|||Change at Hour 60: MMRM was used for analysis. The change from baseline in MADRS total score at each visit was the dependent variable. Treatment, baseline MADRS total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model. All explanatory variables including pooled center were treated as fixed effects.||-1.66|-8.06|0.0033
72406553|NCT02942017|144321623|SUPERIORITY||LS mean difference|-3.56|STANDARD_ERROR_OF_MEAN|2.154||0.1017|TWO_SIDED|95.0|-7.84|0.72|||MMRM|||Change at Day 7: MMRM was used for analysis. The change from baseline in MADRS total score at each visit was the dependent variable. Treatment, baseline MADRS total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.72|-7.84|0.1017
72406554|NCT02942017|144321623|SUPERIORITY||LS mean difference|0.04|STANDARD_ERROR_OF_MEAN|1.884||0.9845|TWO_SIDED|95.0|-3.72|3.79|||MMRM|||Change at Day 30: MMRM was used for analysis. The change from baseline in MADRS total score at each visit was the dependent variable. Treatment, baseline MADRS total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model. All explanatory variables including pooled center were treated as fixed effects.||3.79|-3.72|0.9845
72406555|NCT02942017|144321624|SUPERIORITY||Odds Ratio (OR)|5.0||||0.0005|TWO_SIDED|95.0|2.0|12.5|||GEE method|||Hour 60: GEE method was used for analysis. CGI-I response at each visit was the dependent variable. Treatment, baseline CGI-S score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model.||12.5|2.0|0.0005
72571072|NCT01941940|144670491|SUPERIORITY_OR_OTHER|||||||0.0004|||||||ANOVA|||Analysis for association between DAS28-ESR and ACR50 at Week 52||||0.0004
72406556|NCT02942017|144321624|SUPERIORITY||Odds Ratio (OR)|2.9||||0.0478|TWO_SIDED|95.0|1.0|8.4|||GEE method|||Day 7: GEE method was used for analysis. CGI-I response at each visit was the dependent variable. Treatment, baseline CGI-S score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model.||8.4|1.0|0.0478
72406557|NCT02942017|144321624|SUPERIORITY||Odds Ratio (OR)|1.5||||0.4399|TWO_SIDED|95.0|0.5|4.6|||GEE method|||Day 30: GEE method was used for analysis. CGI-I response at each visit was the dependent variable. Treatment, baseline CGI-S score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model.||4.6|0.5|0.4399
72406558|NCT02942017|144321625|SUPERIORITY||LS Mean Difference|-1.17|STANDARD_ERROR_OF_MEAN|1.041||0.2636|TWO_SIDED|95.0|-3.24|0.9|||MMRM|||Change at Hour 60: MMRM was used for the analysis. The change from baseline in GAD-7 total score at each visit was the dependent variable. Treatment, baseline GAD-7 total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.90|-3.24|0.2636
72406559|NCT02942017|144321625|SUPERIORITY||LS Mean Difference|-0.76|STANDARD_ERROR_OF_MEAN|1.103||0.4897|TWO_SIDED|95.0|-2.96|1.43|||MMRM|||Change at Day 7: MMRM was used for the analysis. The change from baseline in GAD-7 total score at each visit was the dependent variable. Treatment, baseline GAD-7 total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model. All explanatory variables including pooled center were treated as fixed effects.||1.43|-2.96|0.4897
72571073|NCT01941940|144670491|SUPERIORITY_OR_OTHER|||||||0.0004|||||||ANOVA|||Analysis for association between DAS28-ESR and ACR70 at Week 52||||0.0004
72571074|NCT01941940|144670492|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||Analysis for association between DAS28-ESR and EULAR at Week 2||||<0.0001
72571075|NCT01941940|144670492|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||Analysis for association between DAS28-ESR and EULAR at Week 24||||<0.0001
72571076|NCT01941940|144670492|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||Analysis for association between DAS28-ESR and EULAR at Week 52||||<0.0001
72625235|NCT01098747|144780080|SUPERIORITY_OR_OTHER||LS mean difference|-0.59||||0.044|TWO_SIDED|95.0|-1.16|-0.02||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||7 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||-0.02|-1.16|0.044
72524972|NCT00804986|144580255|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-0.21||||0.105||95.0||||p-value represents change from baseline to Week 12 for fasting LDL, 17.6 mg treatment arm in comparison to placebo|ANCOVA|ANCOVA: baseline and treatment||||||0.105
72524973|NCT00804986|144580255|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-0.12||||0.403||95.0||||p-value represents change from baseline to Week 12 for fasting total cholesterol, 0.5 mg treatment arm in comparison to placebo|ANCOVA|ANCOVA: baseline and treatment||||||0.403
72524974|NCT00804986|144580255|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-0.04||||0.799||95.0||||p-value represents change from baseline to Week 12 for fasting total cholesterol, 2.0 mg treatment arm in comparison to placebo|ANCOVA|ANCOVA: baseline and treatment||||||0.799
72524975|NCT00804986|144580255|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-0.32||||0.029||95.0||||p-value represents change from baseline to Week 12 for fasting total cholesterol, 6.2 mg treatment arm in comparison to placebo|ANCOVA|ANCOVA: baseline and treatment||||||0.029
72524976|NCT00804986|144580255|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-0.12||||0.439||95.0||||p-value represents change from baseline to Week 12 for fasting total cholesterol, 12.0 mg treatment arm in comparison to placebo|ANCOVA|ANCOVA: baseline and treatment||||||0.439
72524977|NCT00804986|144580255|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-0.27||||0.062||95.0||||p-value represents change from baseline to Week 12 for fasting total cholesterol, 17.6 mg treatment arm in comparison to placebo|ANCOVA|ANCOVA: baseline and treatment||||||0.062
72524978|NCT00804986|144580256|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-0.16||||0.8003||95.0||||p-value represents change from baseline to Week 12 for fasting weight, 0.5 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||0.8003
72524979|NCT00804986|144580256|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-0.26||||0.6736||95.0||||p-value represents change from baseline to Week 12 for fasting weight, 2.0 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||0.6736
72524980|NCT00804986|144580256|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-1.53||||0.0123||95.0||||p-value represents change from baseline to Week 12 for fasting weight, 6.2 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||0.0123
72524981|NCT00804986|144580256|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-0.44||||0.4771||95.0||||p-value represents change from baseline to Week 12 for fasting weight, 12.0 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||0.4771
72524982|NCT00804986|144580256|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-2.01||||0.0013||95.0||||p-value represents change from baseline to Week 12 for fasting weight, 17.6 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||0.0013
72524983|NCT03296072|144580261|OTHER||Difference of Least Square mean|7.69|||<|0.0001|TWO_SIDED|95.0|5.18|10.19|||ANOVA|From ANOVA with fixed factors for study period and treatment, and a random effect for participant.|Difference is first-named treatment minus second-named treatment such that a positive difference favors the first named treatment.|||10.19|5.18|<.0001
72524984|NCT03296072|144580262|OTHER||Difference of Least Square mean|33.29|||<|0.0001|TWO_SIDED|95.0|28.89|37.68|||ANOVA|From ANOVA with fixed factors for study period and treatment, and a random effect for participant.|Difference is first-named treatment minus second-named treatment such that a positive difference favors the first named treatment.|||37.68|28.89|<.0001
72524985|NCT03296072|144580263|OTHER||Difference of Least Square mean|1.81|||<|0.0001|TWO_SIDED|95.0|1.59|2.04|||ANOVA|From ANOVA with fixed factors for study period and treatment, and a random effect for participant.|Difference is first-named treatment minus second-named treatment such that a positive difference favors the first named treatment.|||2.04|1.59|<.0001
72524986|NCT03296072|144580264|OTHER||Difference of Least Square mean|7.57|||<|0.0001|TWO_SIDED|95.0|5.07|11.07|||ANOVA|From ANOVA with fixed factors for study period and treatment, and a random effect for participant.|Difference is first-named treatment minus second-named treatment such that a positive difference favors the first named treatment.|||11.07|5.07|<.0001
72524987|NCT03296072|144580265|OTHER||Difference of Least Square mean|10.98|||<|0.0001|TWO_SIDED|95.0|6.58|15.37|||ANOVA|From ANOVA with fixed factors for study period and treatment, and a random effect for participant.|Difference is first-named treatment minus second-named treatment such that a positive difference favors the first named treatment.|||15.37|6.58|<.0001
72524988|NCT03296072|144580266|OTHER||Difference of Least Square mean|0.97|||<|0.0001|TWO_SIDED|95.0|0.75|1.2|||ANOVA|From ANOVA with fixed factors for study period and treatment, and a random effect for participant.|Difference is first-named treatment minus second-named treatment such that a positive difference favors the first named treatment.|||1.20|0.75|<.0001
72524989|NCT00654368|144580267|NON_INFERIORITY_OR_EQUIVALENCE|If the lower bound of the one-sided 95% confidence interval (CI), defined below, exceeded the noninferiority margin of -0.6, then noninferiority was to be concluded.|Mean Difference|-0.41|||||TWO_SIDED|95.0|-0.75|-0.06|||||The 95% CI was calculated using the mean square error from an analysis of variance (ANOVA) fitted with effects for treatment and covariates of duration of disease, type of reimbursement, and 6 month DAS28.|||-0.06|-0.75|
72524990|NCT00815776|144580280|NON_INFERIORITY_OR_EQUIVALENCE|The unadjusted reductions are straight arithmetic averages and are supplied for informational purposes only. The pooled variance is calculated from the unadjusted standard deviations, and the t statistic is calculated as described in Laster (2003) using an average sample size of 54 and 106 degrees of freedom.|||||<|0.0096|||||||student's t-test with 2n-2 DoF|||The LS means were used to calculate the test statistic for non-inferiority of the CID to the traditional splint device. The null hypothesis was that the reduction of CMI score for the CID is less than 80% of the reduction in the splint group. A significant p-value(\< 0.05) would reject this null hypothesis in favor of the alternative hypothesis that the CID demonstrated a reduction of at least 80% of that seen in the splint group.||||<0.0096
72524991|NCT00815776|144580281|NON_INFERIORITY_OR_EQUIVALENCE|Safety analyses were performed on the ITT population.||||||0.688|||||||t-test, 1 sided|||Safety analyses were performed on the ITT population. The safety of the CID was characterized by the proportion of subjects with all serious and non-serious study-related adverse events and Unanticipated Adverse Device Events (UADEs). In addition, summaries of the onset, duration, severity, treatment relatedness, and outcome of all adverse events were reported.||||0.688
72406560|NCT02942017|144321625|SUPERIORITY||LS Mean Difference|-1.86|STANDARD_ERROR_OF_MEAN|1.227||0.1341|TWO_SIDED|95.0|-4.3|0.59|||MMRM|||Change at Day 14: MMRM was used for the analysis. The change from baseline in GAD-7 total score at each visit was the dependent variable. Treatment, baseline GAD-7 total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.59|-4.30|0.1341
72406561|NCT02942017|144321625|SUPERIORITY||LS Mean Difference|-1.95|STANDARD_ERROR_OF_MEAN|1.408||0.1691|TWO_SIDED|95.0|-4.76|0.85|||MMRM|||Change at Day 21: MMRM was used for the analysis. The change from baseline in GAD-7 total score at each visit was the dependent variable. Treatment, baseline GAD-7 total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.85|-4.76|0.1691
72406562|NCT02942017|144321625|SUPERIORITY||LS Mean Difference|-0.31|STANDARD_ERROR_OF_MEAN|1.149||0.7852|TWO_SIDED|95.0|-2.6|1.97|||MMRM|||Change at Day 30: MMRM was used for the analysis. The change from baseline in GAD-7 total score at each visit was the dependent variable. Treatment, baseline GAD-7 total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model. All explanatory variables including pooled center were treated as fixed effects.||1.97|-2.60|0.7852
72406563|NCT00457197|144321628|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4709|TWO_SIDED||||||ANCOVA|||Baseline drinks/day used as covariate.||||0.4709
72406564|NCT00457197|144321629|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1272|TWO_SIDED||||||ANCOVA|||Baseline percent heavy drinking days included as covariate.||||0.1272
72406565|NCT00457197|144321630|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9642|TWO_SIDED||||||ANCOVA|||Baseline GGT used as covariate.||||0.9642
72406566|NCT00457197|144321631|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7222|TWO_SIDED||||||ANCOVA|||Baseline AST used as covariate.||||0.7222
72406567|NCT00457197|144321632|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1412|TWO_SIDED||||||ANCOVA|||Baseline ALT used as covariate.||||0.1412
72406568|NCT00457197|144321633|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7071|TWO_SIDED||||||ANCOVA|||Baseline HRSD used as covariate.||||0.7071
72524992|NCT00815776|144580282|SUPERIORITY_OR_OTHER|||||||0.2995||||||From the pilot study, 50 subjects (CID arm) and 25 (exercise arm) were required for at least 80% power to detect a difference in the mean reduction in CMI scores between arms if muPassive is less than approximately 70% of that in the CID arm.|t-test, 2 sided|||A significant p-value for the treatment group effect would indicate that the CID group and Exercise group were significantly different, based on results of a two-sided t test for difference in means, with alpha=0.5, and allowing for unequal sample sizes.||||.2995
72524993|NCT00959699|144580284|SUPERIORITY_OR_OTHER||Strata-Adjusted Difference|33.7||||0.0008|TWO_SIDED|95.0|14.1|53.3||The Cochran-Mantel-Haenszel p-value is adjusted for randomization strata of HCV-RNA (\< or \>= 800,000 IU/mL) and Cirrhosis/Fibrosis (Yes or No)|Cochran-Mantel-Haenszel|||The methodology for 95% Confidence Interval (CI) is based on a Modified Koch approach which adjusted for Randomization Strata of Cirrhosis/Fibrosis (Yes or No). The adjustment of randomization strata of HCV-RNA (\< or \>= 800,000 IU/mL) was not possible due to sparse data.||53.3|14.1|0.0008
72524994|NCT00959699|144580285|SUPERIORITY_OR_OTHER||Observed Difference|34.2||||0.0007|TWO_SIDED|95.0|14.5|53.9||The Cochran-Mantel-Haenszel p-value is adjusted for randomization strata of HCV-RNA (\< or \>= 800,000 IU/mL) and Cirrhosis/Fibrosis (Yes or No)|Cochran-Mantel-Haenszel|||The methodology for 95% CI is based on the asymptotic normal approximation to the binomial distribution||53.9|14.5|0.0007
72625236|NCT01098747|144780080|SUPERIORITY_OR_OTHER||LS mean difference|2.05|||<|0.001|TWO_SIDED|95.0|1.25|2.85||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||8 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||2.85|1.25|<0.001
72406569|NCT00457197|144321634|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2569|TWO_SIDED||||||ANCOVA|||Baseline IDS-SR used as a covariate.||||0.2569
72406570|NCT00457197|144321635|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8814|TWO_SIDED||||||ANCOVA|||Baseline YMRS used as a covariate.||||0.8814
72406571|NCT00457197|144321636|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2473|TWO_SIDED||||||ANCOVA|||Baseline PACS used as a covariate.||||0.2473
72524995|NCT02583360|144580290|SUPERIORITY|||||||0.008|||||||Chi-squared|||||||0.008
72524996|NCT02583360|144580291|SUPERIORITY|||||||0.907|||||||t-test, 2 sided|||||||0.907
72524997|NCT02583360|144580292|SUPERIORITY|||||||0.592|||||||t-test, 2 sided|||||||0.592
72406572|NCT04538664|144321662|SUPERIORITY||Hazard Ratio (HR)|0.395|||<|0.0001|TWO_SIDED|95.0|0.296|0.528|||Log Rank|||||0.528|0.296|<0.0001
72524998|NCT04228445|144580293|SUPERIORITY||Odds Ratio (OR)|14.041|||<|0.0001|TWO_SIDED|95.0|7.394|26.662|||Score statistics for Type 3 GEE analysis|||||26.662|7.394|<0.0001
72524999|NCT04228445|144580293|SUPERIORITY||Odds Ratio (OR)|16.772|||<|0.0001|TWO_SIDED|95.0|8.625|32.617|||Score statistics for Type 3 GEE analysis|||||32.617|8.625|<0.0001
72525000|NCT04228445|144580294|OTHER||Percentage of Responders|87.8|||||TWO_SIDED|95.0|78.6|96.9|||||Missing data imputed as non-responder|||96.9|78.6|
72525001|NCT04228445|144580294|OTHER||Percentage of Responders|87.2|||||TWO_SIDED|95.0|77.7|96.8|||||Missing data imputed as non-responder|||96.8|77.7|
72525002|NCT04228445|144580295|OTHER||percentage of satisfaction|89.8|||||TWO_SIDED|95.0|78.2|95.6||||||||95.6|78.2|
72525003|NCT04228445|144580295|OTHER||percentage of satisfaction|80.9|||||TWO_SIDED|95.0|67.5|89.6||||||||89.6|67.5|
72525004|NCT04228445|144580296|OTHER||median time to visualization (minutes)|6.0|||||TWO_SIDED|95.0|5.25|7.0||||||||7.00|5.25|
72525005|NCT04228445|144580296|OTHER||median time to visualization (minutes)|5.93|||||TWO_SIDED|95.0|5.12|7.0||||||||7.00|5.12|
72525006|NCT04228445|144580297|SUPERIORITY||Odds Ratio (OR)|19.532|||<|0.0001|TWO_SIDED|95.0|8.738|43.663|||Score statistics for Type 3 GEE analysis|||||43.663|8.738|<0.0001
72525007|NCT04228445|144580297|SUPERIORITY||Odds Ratio (OR)|15.73|||<|0.0001|TWO_SIDED|95.0|7.199|34.369|||Score statistics for Type 3 GEE analysis|||||34.369|7.199|<0.0001
72525008|NCT04228445|144580298|OTHER||Percentage of Agreement|91.1|||||TWO_SIDED|||||||||Left Ureter||||
72525009|NCT04228445|144580298|OTHER||Percentage of Agreement|88.4|||||TWO_SIDED|||||||||Left Ureter||||
72525010|NCT04228445|144580298|OTHER||Percentage of Agreement|76.1|||||TWO_SIDED|||||||||Left Ureter||||
72571077|NCT01941940|144670493|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||Analysis for association between CDAI and ACR20 at Week 2||||<0.0001
72571078|NCT01941940|144670493|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||Analysis for association between CDAI and ACR50 at Week 2||||<0.0001
72571079|NCT01941940|144670493|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||Analysis for association between CDAI and ACR70 at Week 2||||<0.0001
72571080|NCT01941940|144670493|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||Analysis for association between CDAI and ACR20 at Week 24||||<0.0001
72571081|NCT01941940|144670493|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||Analysis for association between CDAI and ACR50 at Week 24||||<0.0001
72525011|NCT04228445|144580298|OTHER||Percentage of Agreement|95.6|||||TWO_SIDED|||||||||Right Ureter||||
72571082|NCT01941940|144670493|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||Analysis for association between CDAI and ACR70 at Week 24||||<0.0001
72571083|NCT01941940|144670493|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||Analysis for association between CDAI and ACR20 at Week 52||||<0.0001
72571084|NCT01941940|144670493|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||Analysis for association between CDAI and ACR50 at Week 52||||<0.0001
72571085|NCT01941940|144670493|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||Analysis for association between CDAI and ACR70 at Week 52||||<0.0001
72571086|NCT01941940|144670494|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||Analysis for association between CDAI and EULAR at Week 2||||<0.0001
72571087|NCT01941940|144670494|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||Analysis for association between CDAI and EULAR at Week 24||||<0.0001
72571088|NCT01941940|144670494|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||Analysis for association between CDAI and EULAR at Week 52||||<0.0001
72571089|NCT01941940|144670495|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||Analysis for association between SDAI and ACR20 at Week 2||||<0.0001
72571090|NCT01941940|144670495|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||Analysis for association between SDAI and ACR50 at Week 2||||<0.0001
72571091|NCT01941940|144670495|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||Analysis for association between SDAI and ACR70 at Week 2||||<0.0001
72571092|NCT01941940|144670495|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||Analysis for association between SDAI and ACR20 at Week 24||||<0.0001
72571093|NCT01941940|144670495|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||Analysis for association between SDAI and ACR50 at Week 24||||<0.0001
72571094|NCT01941940|144670495|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||Analysis for association between SDAI and ACR70 at Week 24||||<0.0001
72571095|NCT01941940|144670495|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||Analysis for association between SDAI and ACR20 at Week 52||||<0.0001
72571096|NCT01941940|144670495|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||Analysis for association between SDAI and ACR50 at Week 52||||<0.0001
72571097|NCT01941940|144670495|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||Analysis for association between SDAI and ACR70 at Week 52||||<0.0001
72571098|NCT01941940|144670496|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||Analysis for association between SDAI and EULAR at Week 2||||<0.0001
72571099|NCT01941940|144670496|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||Analysis for association between SDAI and EULAR at Week 24||||<0.0001
72525012|NCT04228445|144580298|OTHER||Percentage of Agreement|86.0|||||TWO_SIDED|||||||||Right Ureter||||
72525013|NCT04228445|144580298|OTHER||Percentage of Agreement|71.6|||||TWO_SIDED|||||||||Right Ureter||||
72525014|NCT04228445|144580299|SUPERIORITY||Odds Ratio (OR)|0.771||||0.4595|TWO_SIDED|95.0|0.388|1.534|||Score statistics for Type 3 GEE analysis|||||1.534|.388|0.4595
72525015|NCT04228445|144580300|SUPERIORITY||Odds Ratio (OR)|1.036||||0.922|TWO_SIDED|95.0|0.509|2.11|||Score statistics for Type 3 GEE analysis|||||2.110|.509|0.9220
72525016|NCT01316380|144580309|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.128|STANDARD_ERROR_OF_MEAN|0.036||0.0005||95.0|0.057|0.199||Step-wise testing for the two treatment groups for the primary endpoint, confirmatory only if previous hypotheses had been successful, significance level of alpha=0.025 (one-sided) for primary endpoint.|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, pooled centre, visit, baseline, treatment\*visit and baseline\*visit.|||0.199|0.057|0.0005
72525017|NCT01316380|144580309|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.159|STANDARD_ERROR_OF_MEAN|0.036|<|0.0001||95.0|0.088|0.23||Step-wise testing for the two treatment groups for the primary endpoint, confirmatory only if previous hypotheses had been successful, significance level of alpha=0.025 (one-sided) for the primary endpoint.|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Tio R2.5 - Placebo. Means are adjusted for treatment, pooled centre, visit, baseline, treatment\*visit and baseline\*visit.|||0.230|0.088|<0.0001
72525018|NCT01316380|144580310|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.122|STANDARD_ERROR_OF_MEAN|0.037||0.001||95.0|0.049|0.194||p-values serve an exploratory function only|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, pooled centre, visit, baseline, treatment\*visit and baseline\*visit.|||0.194|0.049|0.001
72525019|NCT01316380|144580310|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.11|STANDARD_ERROR_OF_MEAN|0.037||0.0028||95.0|0.038|0.182||p-values serve an exploratory function only|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R2.5 - Placebo. Means are adjusted for treatment, pooled centre, visit, baseline, treatment\*visit and baseline\*visit.|||0.182|0.038|0.0028
72525020|NCT01316380|144580311|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.057|STANDARD_ERROR_OF_MEAN|0.042||0.1714||95.0|-0.025|0.14||p-values serve an exploratory function only|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, pooled centre, visit, baseline, treatment\*visit and baseline\*visit.|||0.140|-0.025|0.1714
72525021|NCT01316380|144580311|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.106|STANDARD_ERROR_OF_MEAN|0.042||0.0119||95.0|0.023|0.188||p-values serve an exploratory function only|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R2.5 - Placebo. Means are adjusted for treatment, pooled centre, visit, baseline, treatment\*visit and baseline\*visit.|||0.188|0.023|0.0119
72525022|NCT01316380|144580312|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.125|STANDARD_ERROR_OF_MEAN|0.034||0.0003||95.0|0.058|0.192||p-values serve an exploratory function only|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, pooled centre, visit, baseline, treatment\*visit and baseline\*visit.|||0.192|0.058|0.0003
72625237|NCT01098747|144780080|SUPERIORITY_OR_OTHER||LS mean difference|-0.65||||0.027|TWO_SIDED|95.0|-1.23|-0.08||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||8 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||-0.08|-1.23|0.027
72625238|NCT01098747|144780081|SUPERIORITY_OR_OTHER||LS mean difference|2.73|||<|0.001|TWO_SIDED|95.0|2.27|3.18||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPID 0-2: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||3.18|2.27|<0.001
72625239|NCT01098747|144780081|SUPERIORITY_OR_OTHER||LS mean difference|0.45||||0.007|TWO_SIDED|95.0|0.12|0.78||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPID 0-2: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.78|0.12|0.007
72525023|NCT01316380|144580312|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.149|STANDARD_ERROR_OF_MEAN|0.034|<|0.0001||95.0|0.082|0.216||p-values serve an exploratory function only|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R2.5 - Placebo. Means are adjusted for treatment, pooled centre, visit, baseline, treatment\*visit and baseline\*visit.|||0.216|0.082|<0.0001
72525024|NCT01316380|144580313|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.061|STANDARD_ERROR_OF_MEAN|0.039||0.1182||95.0|-0.016|0.138||p-values serve an exploratory function only|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, pooled centre, visit, baseline, treatment\*visit and baseline\*visit.|||0.138|-0.016|0.1182
72525025|NCT01316380|144580313|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.101|STANDARD_ERROR_OF_MEAN|0.039||0.0102||95.0|0.024|0.178||p-values serve an exploratory function only|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R2.5 - Placebo. Means are adjusted for treatment, pooled centre, visit, baseline, treatment\*visit and baseline\*visit.|||0.178|0.024|0.0102
72525026|NCT01316380|144580315|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.25||||0.2155||95.0|0.03|2.24||Significance level of alpha=0.05 (two-sided). P-values serve an exploratory function only.|Regression, Cox|Parameter estimates of Cox proportional hazard model regarding. Only treatment was fitted as an effect in the model.|If HR is below 1 then favours tiotropium.|Since the percent patients with event is less than 50% the median is not calculable, but Hazard Ratio is still estimable from the Cox model.||2.24|0.03|0.2155
72525027|NCT01316380|144580315|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.53||||0.5071||95.0|0.43|5.44||Significance level of alpha=0.05 (two-sided). P-values serve an exploratory function only.|Regression, Cox|Parameter estimates of Cox proportional hazard model regarding. Only treatment was fitted as an effect in the model.|If HR is below 1 then favours tiotropium.|Since the percent patients with event is less than 50% the median is not calculable, but Hazard Ratio is still estimable from the Cox model.||5.44|0.43|0.5071
72525028|NCT01316380|144580316|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.58||||0.1217||95.0|0.29|1.16||Significance level of alpha=0.05 (two-sided). P-values serve an exploratory function only.|Regression, Cox|Parameter estimates of Cox proportional hazard model regarding. Only treatment was fitted as an effect in the model.|If HR is below 1 then favours tiotropium.|Since only 22 of the 155 patients in the placebo group, 21 of the 154 patients in the Tio R2.5 group and 13 of the 155 patients in the Tio R5 group had asthma exacerbations, the median times were not calculable (nc).||1.16|0.29|0.1217
72525029|NCT01316380|144580316|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.96||||0.8974||95.0|0.53|1.75||Significance level of alpha=0.05 (two-sided). P-values serve an exploratory function only.|Regression, Cox|Parameter estimates of Cox proportional hazard model regarding. Only treatment was fitted as an effect in the model.|If HR is below 1 then favours tiotropium.|Since only 22 of the 155 patients in the placebo group, 21 of the 154 patients in the Tio R2.5 group and 13 of the 155 patients in the Tio R5 group had asthma exacerbations, the median times were not calculable (nc). The Hazard Ratio is still estimable from the Cox model.||1.75|0.53|0.8974
72525030|NCT01316380|144580317|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.222|STANDARD_ERROR_OF_MEAN|0.129||0.0872|TWO_SIDED|95.0|-0.032|0.476||p-values serve an exploratory function only|Mixed Models Analysis||Tio R2.5 - Placebo. Means are adjusted for treatment, centre, week, baseline, treatment\*week and baseline\*week.|Restricted maximum likelihood (REML)- based repeated measures model was used.||0.476|-0.032|0.0872
72525031|NCT01316380|144580317|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.033|STANDARD_ERROR_OF_MEAN|0.129||0.7995|TWO_SIDED|95.0|-0.287|0.221||p-values serve an exploratory function only|Mixed Models Analysis||Tio R5 - Placebo. Means are adjusted for treatment, centre, week, baseline, treatment\*week and baseline\*week.|Restricted maximum likelihood (REML)- based repeated measures model was used.||0.221|-0.287|0.7995
72525032|NCT01316380|144580318|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.097|STANDARD_ERROR_OF_MEAN|0.076||0.2038|TWO_SIDED|95.0|-0.053|0.247||p-values serve an exploratory function only|Mixed Models Analysis||Tio R2.5 - Placebo. Means are adjusted for treatment, centre, week, baseline, treatment\*week and baseline\*week.|Restricted maximum likelihood (REML)- based repeated measures model was used. Means are adjusted for treatment, centre, week, baseline, treatment\*week and baseline\*week.||0.247|-0.053|0.2038
72525033|NCT01316380|144580318|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.009|STANDARD_ERROR_OF_MEAN|0.076||0.9104|TWO_SIDED|95.0|-0.158|0.141||p-values serve an exploratory function only|Mixed Models Analysis||Tio R5 - Placebo. Means are adjusted for treatment, centre, week, baseline, treatment\*week and baseline\*week.|Restricted maximum likelihood (REML)- based repeated measures model was used.||0.141|-0.158|0.9104
72525034|NCT01316380|144580319|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.131|STANDARD_ERROR_OF_MEAN|0.068||0.0559|TWO_SIDED|95.0|-0.003|0.265||p-values serve an exploratory function only|Mixed Models Analysis||Tio R2.5 - Placebo. Means are adjusted for treatment, centre, week, baseline, treatment\*week and baseline\*week.|Restricted maximum likelihood (REML)- based repeated measures model was used.||0.265|-0.003|0.0559
72406573|NCT06561217|144321678|NON_INFERIORITY|A predefined non-inferiority margin of 0.05 was used. The primary study was powered on a retrospective, paired, non-inferiority design to evaluate abstraction accuracy of elements commonly used to help screen patients for clinical trials.|Mean Difference (Final Values)|0.02|||<|0.001|ONE_SIDED|95.0|0.00007515||||Wilcoxon (Mann-Whitney)||The upper bound of the 95% confidence interval is Inf due to the test being one-sided. Alternative hypothesis: true median location shift is greater than -0.05|A Shapiro-Wilk test was used to assess normality of paired differences in chart-level accuracy (alpha = 0.05). A one-sided, paired Wilcoxon Rank Sum test (alpha = 0.05) was employed to test the primary null hypothesis of whether chart-level accuracy of the Human+AI arm for EHR chart abstraction was non-inferior to the chart-level accuracy of a Human-alone arm abstraction by at least 5% (i.e., noninferiority margin).|||0.00007515|<0.001
72406574|NCT06561217|144321678|SUPERIORITY|The primary study was powered on a retrospective, paired, superiority design to evaluate abstraction accuracy of elements commonly used to help screen patients for clinical trials.|Mean Difference (Final Values)|0.02||||0.002|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||A Shapiro-Wilk test was used to assess normality of paired differences in chart-level accuracy (alpha = 0.05). A one-sided, paired Wilcoxon Rank Sum test (alpha = 0.05) was employed to test the null hypothesis of whether chart-level accuracy of the Human+AI arm for EHR chart abstraction was superior to the chart-level accuracy of a Human-alone arm abstraction.||||0.002
72525035|NCT01316380|144580319|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.01|STANDARD_ERROR_OF_MEAN|0.068||0.8795|TWO_SIDED|95.0|-0.144|0.123||p-values serve an exploratory function only|Mixed Models Analysis||Tio R5 - Placebo. Means are adjusted for treatment, centre, week, baseline, treatment\*week and baseline\*week.|Restricted maximum likelihood (REML)- based repeated measures model was used.||0.123|-0.144|0.8795
72525036|NCT02485860|144580345|SUPERIORITY|||||||0.094|||||||t-test, 2 sided|||||||0.094
72525037|NCT02332876|144580346|SUPERIORITY||||||<|0.05|||||||Mixed Models Analysis|||||||<0.05
72525038|NCT02402881|144580366|OTHER||Odds Ratio (OR)|1.0|||<|0.05|TWO_SIDED|95.0|||||Mixed Models Analysis|We used generalized linear mixed-effects models with multiple outputation reiterated 1000 times to bootstrap the 95% CIs and the P values.||Our primary outcome was the proportion of non-administered doses of prescribed pharmacologic VTE prophylaxis. We compared rates of VTE prophylaxis non-administration pre-post-intervention. For estimating conditional odds ratios (ORs) and their 95% confidence intervals (CIs), the binomial family and a logit link were used; for estimating the conditional proportions, the Poisson family and a log link were used.||||<0.05
72525039|NCT02402881|144580367|OTHER||Odds Ratio (OR)|1.0|||<|0.05|TWO_SIDED|95.0|||||Mixed Models Analysis|We used generalized linear mixed-effects models with multiple outputation reiterated 1000 times to bootstrap the 95% CIs and the P values.||Our secondary outcome was the proportion of VTE events. We compared rates of VTE prophylaxis nonadministration pre-post-intervention. For estimating conditional odds ratios (ORs) and their 95% CIs, the binomial family and a logit link were used; for estimating the conditional proportions, the Poisson family and a log link were used.||||<0.05
72525040|NCT03325010|144580368|SUPERIORITY||Mean Difference (Net)|-2.1|STANDARD_ERROR_OF_MEAN|1.5||0.1768|TWO_SIDED|95.0|-5.2|1.0||Nominal p-value is considered statistically significant if less than 0.05. To control for multiplicity, comparisons were tested sequentially.|Mixed Models Analysis|||||1.0|-5.2|0.1768
72525041|NCT03325010|144580369|SUPERIORITY||Mean Difference (Net)|-0.3|STANDARD_ERROR_OF_MEAN|0.2||0.1095|TWO_SIDED|95.0|-0.6|0.1||To control for multiplicity, comparisons were tested sequentially. Nominal p-value for this outcome measure would only be evaluated for statistical significance if the primary outcome measure was statistically significant.|Mixed Models Analysis|||||0.1|-0.6|0.1095
72525042|NCT03325010|144580370|SUPERIORITY||Risk Difference (RD)|3.0||||0.819|TWO_SIDED|||||To control for multiplicity, comparisons were tested sequentially. Nominal p-value for this outcome measure would only be evaluated for statistical significance if the primary and preceding secondary outcome measures were statistically significant.|Cochran-Mantel-Haenszel|Stratified by baseline weight group (\<50 kg, ≥50 kg).||||||0.8190
72525043|NCT03325010|144580371|SUPERIORITY||Risk Difference (RD)|33.6||||0.0008|TWO_SIDED|||||To control for multiplicity, comparisons were tested sequentially. Nominal p-value for this outcome measure would only be evaluated for statistical significance if the primary and preceding secondary outcome measures were statistically significant.|Cochran-Mantel-Haenszel|Stratified by baseline weight group (\<50 kg, ≥50 kg)||||||0.0008
72525044|NCT02614261|144580372|SUPERIORITY||LSMean Difference|-2.09|STANDARD_ERROR_OF_MEAN|0.42|<|0.001|TWO_SIDED|95.0|-2.92|-1.26|||Mixed Models Analysis|||||-1.26|-2.92|<.001
72525045|NCT02614261|144580372|SUPERIORITY||LSMean Difference|-1.88|STANDARD_ERROR_OF_MEAN|0.42|<|0.001|TWO_SIDED|95.0|-2.71|-1.05|||Mixed Models Analysis|||||-1.05|-2.71|<.001
72525046|NCT02614261|144580373|SUPERIORITY||Odds Ratio (OR)|1.623||||0.004|TWO_SIDED|95.0|1.167|2.256|||CPRMM|Categorical pseudo likelihood-based repeated measures model (CPRMM)||Reduction from Baseline ≥50%,||2.256|1.167|.004
72525047|NCT02614261|144580373|SUPERIORITY||Odds Ratio (OR)|1.788|||<|0.001|TWO_SIDED|95.0|1.291|2.474|||CPRMM|Categorical pseudo likelihood-based repeated measures model (CPRMM)||Reduction from Baseline ≥50%||2.474|1.291|<.001
72525048|NCT02614261|144580373|SUPERIORITY||Odds Ratio (OR)|1.498||||0.102|TWO_SIDED|95.0|0.923|2.43|||CPRMM|Categorical pseudo likelihood-based repeated measures model (CPRMM)||Reduction from Baseline ≥75%||2.430|0.923|.102
72571100|NCT01941940|144670496|SUPERIORITY_OR_OTHER|||||||0.0016|||||||ANOVA|||Analysis for association between SDAI and EULAR at Week 52||||0.0016
72571101|NCT01941940|144670499|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Rank Sum and Signed Rank Tests|||Analysis for change from baseline to Week 2 was performed using Wilcoxon Rank Sum and Signed Rank Tests for dependent sample.||||<0.0001
72571102|NCT01941940|144670499|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Rank Sum and Signed Rank Tests|||Analysis for change from baseline to Week 24 was performed using Wilcoxon Rank Sum and Signed Rank Tests for dependent sample.||||<0.0001
72571103|NCT01941940|144670499|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Rank Sum and Signed Rank Tests|||Analysis for change from baseline to Week 52 was performed using Wilcoxon Rank Sum and Signed Rank Tests for dependent sample.||||<0.0001
72571104|NCT01941940|144670500|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Rank Sum and Signed Rank Tests|||Analysis for change from baseline to Week 2 was performed using Wilcoxon Rank Sum and Signed Rank Tests for dependent sample.||||<0.0001
72571105|NCT01941940|144670500|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Rank Sum and Signed Rank Tests|||Analysis for change from baseline to Week 24 was performed using Wilcoxon Rank Sum and Signed Rank Tests for dependent sample.||||<0.0001
72406575|NCT06561217|144321679|EQUIVALENCE|Null hypothesis: True difference is equal to 0. Alternate hypothesis: true difference is not equal to 0|Median Difference (Final Values)|0.66||||0.513|TWO_SIDED|95.0|-1.25|2.55|||Wilcoxon (Mann-Whitney)|||A two-sided, paired Wilcoxon Rank Sum test (alpha = 0.05) was employed to test for difference between chart-level efficiency of the Human+AI arm and chart-level efficiency of the Human-alone arm abstraction.||2.55|-1.25|0.513
72406576|NCT04552587|144321690|SUPERIORITY|||||||0.23|||||||Wilcoxon (Mann-Whitney)|||We compared change from baseline to follow up in our single group of caregivers.||||0.23
72406577|NCT00613509|144321713|SUPERIORITY_OR_OTHER|||||||0.9406|TWO_SIDED|95.0|||||Log Rank|||||||0.9406
72525049|NCT02614261|144580373|SUPERIORITY||Odds Ratio (OR)|1.819||||0.011|TWO_SIDED|95.0|1.146|2.888|||CPRMM|Categorical pseudo likelihood-based repeated measures model (CPRMM)||Reduction from Baseline ≥75%||2.888|1.146|.011
72525050|NCT02614261|144580373|SUPERIORITY||Odds Ratio (OR)|0.761||||0.729|TWO_SIDED|95.0|0.163|3.563|||CPRMM|Categorical pseudo likelihood-based repeated measures model (CPRMM)||Reduction from Baseline ≥100%||3.563|0.163|0.729
72525051|NCT02614261|144580373|SUPERIORITY||Odds Ratio (OR)|1.897||||0.276|TWO_SIDED|95.0|0.6|5.998|||CPRMM|Categorical pseudo likelihood-based repeated measures model (CPRMM)||Reduction from Baseline ≥100%||5.998|0.600|.276
72525052|NCT02614261|144580374|SUPERIORITY||LSMean Difference|5.06|STANDARD_ERROR_OF_MEAN|1.5|<|0.001|TWO_SIDED|95.0|2.12|7.99|||Mixed Models Analysis|||||7.99|2.12|<.001
72525053|NCT02614261|144580374|SUPERIORITY||LSMean Difference|6.29|STANDARD_ERROR_OF_MEAN|1.66|<|0.001|TWO_SIDED|95.0|3.03|9.55|||Mixed Models Analysis|||||9.55|3.03|<.001
72525054|NCT02614261|144580375|SUPERIORITY||LSMean Difference|-2.51|STANDARD_ERROR_OF_MEAN|0.38|<|0.001|TWO_SIDED|95.0|-3.27|-1.76|||Mixed Models Analysis|||||-1.76|-3.27|<.001
72525055|NCT02614261|144580375|SUPERIORITY||LSMean Difference|-2.01|STANDARD_ERROR_OF_MEAN|0.38|<|0.001|TWO_SIDED|95.0|-2.77|-1.26|||Mixed Models Analysis|||||-1.26|-2.77|<.001
72525056|NCT02614261|144580376|SUPERIORITY||LSMean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.1||0.181|TWO_SIDED|95.0|-0.34|0.06|||Mixed Models Analysis|||||0.06|-0.34|.181
72525057|NCT02614261|144580376|SUPERIORITY||LSMean Difference|-0.28|STANDARD_ERROR_OF_MEAN|0.1||0.006|TWO_SIDED|95.0|-0.48|-0.08|||Mixed Models Analysis|||||-0.08|-0.48|.006
72525058|NCT02614261|144580377|SUPERIORITY||LSMean Difference|-22.71|STANDARD_ERROR_OF_MEAN|4.6|<|0.001|TWO_SIDED|95.0|-31.74|-13.69|||Mixed Models Analysis|||||-13.69|-31.74|<.001
72525059|NCT02614261|144580377|SUPERIORITY||LSMean Difference|-18.09|STANDARD_ERROR_OF_MEAN|4.58|<|0.001|TWO_SIDED|95.0|-27.09|-9.09|||Mixed Models Analysis|||||-9.09|-27.09|<.001
72525060|NCT02614261|144580378|SUPERIORITY||LSMean Difference|-8.74|STANDARD_ERROR_OF_MEAN|3.9||0.025|TWO_SIDED|95.0|-16.39|-1.08|||ANCOVA|||||-1.08|-16.39|.025
72525061|NCT02614261|144580378|SUPERIORITY||LSMean Difference|-5.49|STANDARD_ERROR_OF_MEAN|3.88||0.157|TWO_SIDED|95.0|-13.1|2.12|||ANCOVA|||||2.12|-13.10|.157
72525062|NCT02614261|144580379|SUPERIORITY|||||||0.263|||||||Cochran-Mantel-Haenszel|||||||.263
72525063|NCT02614261|144580379|SUPERIORITY|||||||0.29|||||||Cochran-Mantel-Haenszel|||||||.290
72525064|NCT00460525|144580404|SUPERIORITY_OR_OTHER||Vaccine Efficacy, VE=1-RR=1-exp(ß)|0.17||||0.175||95.0|-0.09|0.37||The a priori threshold for statistical significance was set at 0.05.|Regression, Cox|No adjustments were made.|Vaccine efficacy (VE) was defined as one minus the relative risk (RR), which was estimated by exponentiating the treatment parameter (ß) from the Cox model fit.|Time to first clinical malaria episode with significant parasitemia (2500/mm\^3) and temperature of greater than or equal to 37.5 degrees C was analyzed by fitting a Cox Proportional Hazards model. The null hypothesis of no vaccine efficacy was tested by the stratified log-rank test (score test). The point and interval estimates for vaccine efficacy were obtained by transforming those for treatment effect in the model.||0.37|-0.09|0.175
72525065|NCT00460525|144580406|SUPERIORITY_OR_OTHER||Vaccine Efficacy, VE=1-RR=1-exp(ß)|0.2||||0.068||95.0|-0.02|0.37||The a priori threshold for statistical significance was set at 0.05.|Poisson regression|No adjustments|Vaccine efficacy (VE) was defined as one minus the relative risk (RR), which was estimated by exponentiating the treatment parameter (ß) from the Poisson model fit.|Incidence density, defined as number of clinical malaria episodes per PYAR, was compared using Poisson regression. The null hypothesis of no vaccine efficacy was tested. The point and interval estimates for vaccine efficacy were obtained by transforming those for treatment effect in the model.||0.37|-0.02|0.068
72525066|NCT03073200|144580421|SUPERIORITY||Mean Difference (Final Values)|63.7|||<|0.001|TWO_SIDED|95.0|51.0|76.4|||Fisher Exact|||||76.4|51.0|<0.001
72525067|NCT03073200|144580422|SUPERIORITY||Mean Difference (Final Values)|70.2|||<|0.001|TWO_SIDED|95.0|59.3|81.0|||Fisher Exact|||||81|59.3|<0.001
72525068|NCT03073200|144580423|SUPERIORITY||Mean Difference (Final Values)|72.9|||<|0.001|TWO_SIDED|95.0|63.3|82.5|||Fisher Exact|||||82.5|63.3|<0.001
72525069|NCT03073200|144580424|SUPERIORITY||Mean Difference (Final Values)|50.4|||<|0.001|TWO_SIDED|95.0|40.6|60.2|||Fisher Exact|||||60.2|40.6|<0.001
72525070|NCT03073200|144580425|SUPERIORITY||Mean Difference (Final Values)|47.8|||<|0.001|TWO_SIDED|95.0|38.0|57.6|||Fisher Exact|||||57.6|38.0|<0.001
72525071|NCT03073200|144580426|SUPERIORITY||Mean Difference (Final Values)|45.0|||<|0.001|TWO_SIDED|95.0|33.2|56.8|||Fisher Exact|||||56.8|33.2|<0.001
72525072|NCT03073200|144580427|SUPERIORITY||Mean Difference (Final Values)|40.7|||<|0.001|TWO_SIDED|95.0|29.3|52.0|||Fisher Exact|||||52.0|29.3|<0.001
72525073|NCT03073200|144580428|SUPERIORITY||Mean Difference (Final Values)|51.1|||<|0.001|TWO_SIDED|95.0|35.3|66.9|||Fisher Exact|||||66.9|35.3|<0.001
72525074|NCT03073200|144580429|SUPERIORITY||Mean Difference (Final Values)|41.1|||<|0.001|TWO_SIDED|95.0|27.0|55.2|||Fisher Exact|||||55.2|27.0|<0.001
72525075|NCT03073200|144580430|SUPERIORITY||Mean Difference (Final Values)|-17.04|STANDARD_ERROR_OF_MEAN|5.747||0.005|TWO_SIDED|95.0|-28.7|-5.38|||Mixed Models Analysis|||||-5.38|-28.70|0.005
72525076|NCT03073200|144580431|SUPERIORITY||Mean Difference (Final Values)|-15.36|STANDARD_ERROR_OF_MEAN|1.682|<|0.001|TWO_SIDED|95.0|-18.69|-12.04|||Mixed Models Analysis|||||-12.04|-18.69|<0.001
72525077|NCT03073200|144580432|SUPERIORITY||Mean Difference (Final Values)|-12.01|STANDARD_DEVIATION|3.853||0.006|TWO_SIDED|95.0|-20.11|-3.9|||Mixed Models Analysis|||||-3.90|-20.11|0.006
72525078|NCT03073200|144580435|SUPERIORITY||Mean Difference (Final Values)|20.9||||0.089|TWO_SIDED|95.0|0.1|41.7|||Fisher Exact|||||41.7|0.1|0.089
72525079|NCT03073200|144580436|SUPERIORITY||Mean Difference (Final Values)|23.0||||0.07|TWO_SIDED|95.0|0.6|45.4|||Fisher Exact|||||45.4|0.6|0.070
72525080|NCT04757376|144580448|EQUIVALENCE|Statistical equivalence: the 90% confidence interval (CI) of the difference in the mean of the primary efficacy endpoint between treatment groups was entirely within an equivalence margin, \[- 1.45, + 1.45\].|Mean Difference (Final Values)|-0.19|||||TWO_SIDED|90.0|-0.76|0.38|||ANCOVA|ANCOVA included the treatment as a fixed effect and age, baseline LS-BMD T-score, and prior bisphosphonates therapy (Yes versus No) as covariates.||||0.38|-0.76|
72525081|NCT02550093|144580462|SUPERIORITY_OR_OTHER_LEGACY|||||||0.47|||||||Wilcoxon (Mann-Whitney)|||HEAT||||.47
72525082|NCT02550093|144580462|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7|||||||Wilcoxon (Mann-Whitney)|||COLD||||0.70
72525083|NCT02550093|144580463|SUPERIORITY_OR_OTHER_LEGACY|||||||0.84|||||||Wilcoxon (Mann-Whitney)|||HEAT||||0.84
72525084|NCT02550093|144580463|SUPERIORITY_OR_OTHER_LEGACY|||||||0.95|||||||Wilcoxon (Mann-Whitney)|||COLD||||0.95
72525085|NCT02550093|144580464|SUPERIORITY_OR_OTHER_LEGACY|||||||0.92|||||||Wilcoxon (Mann-Whitney)|||HEAT||||0.92
72625240|NCT01098747|144780081|SUPERIORITY_OR_OTHER||LS mean difference|4.29|||<|0.001|TWO_SIDED|95.0|3.6|4.98||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPID 0-3: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||4.98|3.60|<0.001
72625241|NCT01098747|144780081|SUPERIORITY_OR_OTHER||LS mean difference|0.37||||0.144|TWO_SIDED|95.0|-0.13|0.87||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPID 0-3: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.87|-0.13|0.144
72525086|NCT02550093|144580464|SUPERIORITY_OR_OTHER_LEGACY|||||||0.63|||||||Wilcoxon (Mann-Whitney)|||COLD||||0.63
72525087|NCT02550093|144580465|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6|||||||Wilcoxon (Mann-Whitney)|||||||0.60
72525088|NCT02550093|144580466|SUPERIORITY_OR_OTHER_LEGACY|||||||0.68|||||||Wilcoxon (Mann-Whitney)|||||||0.68
72525089|NCT02550093|144580467|SUPERIORITY_OR_OTHER_LEGACY|||||||0.62|||||||Wilcoxon (Mann-Whitney)|||||||0.62
72525090|NCT02550093|144580468|SUPERIORITY_OR_OTHER_LEGACY|||||||0.97|||||||Wilcoxon (Mann-Whitney)|||||||0.97
72406578|NCT00613509|144321713|SUPERIORITY_OR_OTHER|||||||0.9179|TWO_SIDED|95.0|||||Likelihood ratio test|||||||0.9179
72525091|NCT02550093|144580469|SUPERIORITY_OR_OTHER_LEGACY|||||||0.97|||||||Wilcoxon (Mann-Whitney)|||||||0.97
72525092|NCT02550093|144580470|SUPERIORITY_OR_OTHER_LEGACY|||||||0.61|||||||Wilcoxon (Mann-Whitney)|||||||0.61
72525093|NCT02550093|144580471|SUPERIORITY_OR_OTHER_LEGACY|||||||0.71|||||||Wilcoxon (Mann-Whitney)|||||||0.71
72525094|NCT02550093|144580472|SUPERIORITY_OR_OTHER_LEGACY|||||||0.74|||||||Wilcoxon (Mann-Whitney)|||||||0.74
72525095|NCT02550093|144580473|SUPERIORITY_OR_OTHER_LEGACY|||||||0.75|||||||Wilcoxon (Mann-Whitney)|||||||0.75
72525096|NCT04964557|144580523|SUPERIORITY||Mean Difference (Final Values)|-62.3|||<|0.001|TWO_SIDED|95.0|-68.0|-56.6|||ANCOVA|||||-56.6|-68|<0.001
72525097|NCT04964557|144580524|SUPERIORITY||Mean Difference (Final Values)|-76.7|||<|0.001|TWO_SIDED|95.0|-81.7|-71.7|||ANCOVA|||||-71.7|-81.7|<0.001
72525098|NCT03649815|144580539|OTHER|||||||0.067|||||||Paired Sample T-Test|||||||0.067
72525099|NCT03649815|144580539|OTHER|||||||0.071||||||Controlled for gender, age, and baseline symptomatology|Paired Sample T-Test|||||||0.071
72525100|NCT03649815|144580540|OTHER|||||||0.047|||||||Paired Sample T-Test|||||||0.047
72525101|NCT03649815|144580540|OTHER|||||||0.036||||||Controlled for gender, age and baseline symptomatology|Paired Sample T-Test|||||||0.036
72525102|NCT03649815|144580541|OTHER|||||||0.032|||||||Paired Sample T-Test|||||||0.032
72525103|NCT03649815|144580541|OTHER|||||||0.006||||||Controlled for gender, age and baseline symptomatology|Paired Sample T-Test|||||||0.006
72525104|NCT02859558|144580558|SUPERIORITY|||||||0.48||||||No adjustments for multiple comparisons. P-value based on two-sided test.|Fisher Exact|||Results from Integrase Assay. Null Hypothesis: There is no difference between Arm 1 and Arm 2 in the proportion of participants with undetectable CA-DNA.||||0.48
72525105|NCT02859558|144580558|SUPERIORITY|||||||1||||||No adjustments for multiple comparisons. P-value based on two-sided test.|Fisher Exact|||Results from Integrase Assay. Null Hypothesis: There is no difference between Arm 1 and Arm 3 in the proportion of participants with undetectable CA-DNA.||||1
72525106|NCT02859558|144580558|SUPERIORITY|||||||0.5||||||No adjustments for multiple comparisons. P-value based on two-sided test.|Fisher Exact|||Results from Integrase Assay. Null Hypothesis: There is no difference between Arm 2 and Arm 3 in the proportion of participants with undetectable CA-DNA.||||0.50
72525107|NCT02859558|144580558|SUPERIORITY|||||||1||||||No adjustments for multiple comparisons. P-value based on two-sided test.|Fisher Exact|||Results from Gag Assay. Null Hypothesis: There is no difference between Arm 1 and Arm 2 in the proportion of participants with undetectable CA-DNA.||||1
72525108|NCT02859558|144580558|SUPERIORITY|||||||0.44||||||No adjustments for multiple comparisons. P-value based on two-sided test.|Fisher Exact|||Results from Gag Assay. Null Hypothesis: There is no difference between Arm 1 and Arm 3 in the proportion of participants with undetectable CA-DNA.||||0.44
72525109|NCT02859558|144580558|SUPERIORITY|||||||1||||||No adjustments for multiple comparisons. P-value based on two-sided test.|Fisher Exact|||Results from Gag Assay. Null Hypothesis: There is no difference between Arm 2 and Arm 3 in the proportion of participants with undetectable CA-DNA.||||1
72525110|NCT02859558|144580559|SUPERIORITY|||||||0.39||||||No adjustments for multiple comparisons. P-value based on two-sided test.|Wilcoxon (Mann-Whitney)|||Null Hypothesis: There is no difference between Arm 1 and Arm 2 in percentage of HIV-1-specific CD4+ T-cells expressing any cytokine (CD40L, CD107a, IFNg, MIP1B, TNFa) in response to Env protein stimulant.||||0.39
72525111|NCT02859558|144580559|SUPERIORITY|||||||0.46||||||No adjustments for multiple comparisons. P-value based on two-sided test.|Wilcoxon (Mann-Whitney)|||Null Hypothesis: There is no difference between Arm 1 and Arm 3 in percentage of HIV-1-specific CD4+ T-cells expressing any cytokine (CD40L, CD107a, IFNg, MIP1B, TNFa) in response to Env protein stimulant.||||0.46
72525112|NCT02859558|144580559|SUPERIORITY|||||||0.056||||||No adjustments for multiple comparisons. P-value based on two-sided test.|Wilcoxon (Mann-Whitney)|||Null Hypothesis: There is no difference between Arm 2 and Arm 3 in percentage of HIV-1-specific CD4+ T-cells expressing any cytokine (CD40L, CD107a, IFNg, MIP1B, TNFa) in response to Env protein stimulant.||||0.056
72525113|NCT02859558|144580559|SUPERIORITY|||||||0.025||||||No adjustments for multiple comparisons. P-value based on two-sided test.|Wilcoxon (Mann-Whitney)|||Null Hypothesis: There is no difference between Arm 1 and Arm 2 in percentage of HIV-1-specific CD4+ T-cells expressing any cytokine (CD40L, CD107a, IFNg, MIP1B, TNFa) in response to Gag protein stimulant.||||0.025
72525114|NCT02859558|144580559|SUPERIORITY|||||||0.072||||||No adjustments for multiple comparisons. P-value based on two-sided test.|Wilcoxon (Mann-Whitney)|||Null Hypothesis: There is no difference between Arm 1 and Arm 3 in percentage of HIV-1-specific CD4+ T-cells expressing any cytokine (CD40L, CD107a, IFNg, MIP1B, TNFa) in response to Gag protein stimulant.||||0.072
72525115|NCT02859558|144580559|SUPERIORITY|||||||0.47||||||No adjustments for multiple comparisons. P-value based on two-sided test.|Wilcoxon (Mann-Whitney)|||Null Hypothesis: There is no difference between Arm 2 and Arm 3 in percentage of HIV-1-specific CD4+ T-cells expressing any cytokine (CD40L, CD107a, IFNg, MIP1B, TNFa) in response to Gag protein stimulant.||||0.47
72525116|NCT02859558|144580559|SUPERIORITY|||||||0.086||||||No adjustments for multiple comparisons. P-value based on two-sided test.|Wilcoxon (Mann-Whitney)|||Null Hypothesis: There is no difference between Arm 1 and Arm 2 in percentage of HIV-1-specific CD4+ T-cells expressing any cytokine (CD40L, CD107a, IFNg, MIP1B, TNFa) in response to Nef protein stimulant.||||0.086
72525117|NCT02859558|144580559|SUPERIORITY|||||||0.18||||||No adjustments for multiple comparisons. P-value based on two-sided test.|Wilcoxon (Mann-Whitney)|||Null Hypothesis: There is no difference between Arm 1 and Arm 3 in percentage of HIV-1-specific CD4+ T-cells expressing any cytokine (CD40L, CD107a, IFNg, MIP1B, TNFa) in response to Nef protein stimulant.||||0.18
72525118|NCT02859558|144580559|SUPERIORITY|||||||0.88||||||No adjustments for multiple comparisons. P-value based on two-sided test.|Wilcoxon (Mann-Whitney)|||Null Hypothesis: There is no difference between Arm 2 and Arm 3 in percentage of HIV-1-specific CD4+ T-cells expressing any cytokine (CD40L, CD107a, IFNg, MIP1B, TNFa) in response to Nef protein stimulant.||||0.88
72525119|NCT02859558|144580559|SUPERIORITY|||||||0.061||||||No adjustments for multiple comparisons. P-value based on two-sided test.|Wilcoxon (Mann-Whitney)|||Null Hypothesis: There is no difference between Arm 1 and Arm 2 in percentage of HIV-1-specific CD4+ T-cells expressing any cytokine (CD40L, CD107a, IFNg, MIP1B, TNFa) in response to Pol protein stimulant.||||0.061
72525120|NCT02859558|144580559|SUPERIORITY|||||||0.042||||||No adjustments for multiple comparisons. P-value based on two-sided test.|Wilcoxon (Mann-Whitney)|||Null Hypothesis: There is no difference between Arm 1 and Arm 3 in percentage of HIV-1-specific CD4+ T-cells expressing any cytokine (CD40L, CD107a, IFNg, MIP1B, TNFa) in response to Pol protein stimulant.||||0.042
72525121|NCT02859558|144580559|SUPERIORITY|||||||0.54||||||No adjustments for multiple comparisons. P-value based on two-sided test.|Wilcoxon (Mann-Whitney)|||Null Hypothesis: There is no difference between Arm 2 and Arm 3 in percentage of HIV-1-specific CD4+ T-cells expressing any cytokine (CD40L, CD107a, IFNg, MIP1B, TNFa) in response to Pol protein stimulant.||||0.54
72525122|NCT02859558|144580560|SUPERIORITY|||||||0.97||||||No adjustments for multiple comparisons. P-value based on two-sided test.|Wilcoxon (Mann-Whitney)|||Null Hypothesis: There is no difference between Arm 1 and Arm 2 in percentage of HIV-1-specific CD8+ T-cells expressing any cytokine (CD40L, CD107a, IFNg, MIP1B, TNFa) in response to Env protein stimulant.||||0.97
72525123|NCT02859558|144580560|SUPERIORITY|||||||0.21||||||No adjustments for multiple comparisons. P-value based on two-sided test.|Wilcoxon (Mann-Whitney)|||Null Hypothesis: There is no difference between Arm 1 and Arm 3 in percentage of HIV-1-specific CD8+ T-cells expressing any cytokine (CD40L, CD107a, IFNg, MIP1B, TNFa) in response to Env protein stimulant.||||0.21
72525124|NCT02859558|144580560|SUPERIORITY|||||||0.12||||||No adjustments for multiple comparisons. P-value based on two-sided test.|Wilcoxon (Mann-Whitney)|||Null Hypothesis: There is no difference between Arm 2 and Arm 3 in percentage of HIV-1-specific CD8+ T-cells expressing any cytokine (CD40L, CD107a, IFNg, MIP1B, TNFa) in response to Env protein stimulant.||||0.12
72525125|NCT02859558|144580560|SUPERIORITY|||||||0.055||||||No adjustments for multiple comparisons. P-value based on two-sided test.|Wilcoxon (Mann-Whitney)|||Null Hypothesis: There is no difference between Arm 1 and Arm 2 in percentage of HIV-1-specific CD8+ T-cells expressing any cytokine (CD40L, CD107a, IFNg, MIP1B, TNFa) in response to Gag protein stimulant.||||0.055
72525126|NCT02859558|144580560|SUPERIORITY|||||||0.28||||||No adjustments for multiple comparisons. P-value based on two-sided test.|Wilcoxon (Mann-Whitney)|||Null Hypothesis: There is no difference between Arm 1 and Arm 3 in percentage of HIV-1-specific CD8+ T-cells expressing any cytokine (CD40L, CD107a, IFNg, MIP1B, TNFa) in response to Gag protein stimulant.||||0.28
72525127|NCT02859558|144580560|SUPERIORITY|||||||0.38||||||No adjustments for multiple comparisons. P-value based on two-sided test.|Wilcoxon (Mann-Whitney)|||Null Hypothesis: There is no difference between Arm 2 and Arm 3 in percentage of HIV-1-specific CD8+ T-cells expressing any cytokine (CD40L, CD107a, IFNg, MIP1B, TNFa) in response to Gag protein stimulant.||||0.38
72525128|NCT02859558|144580560|SUPERIORITY|||||||0.35||||||No adjustments for multiple comparisons. P-value based on two-sided test.|Wilcoxon (Mann-Whitney)|||Null Hypothesis: There is no difference between Arm 1 and Arm 2 in percentage of HIV-1-specific CD8+ T-cells expressing any cytokine (CD40L, CD107a, IFNg, MIP1B, TNFa) in response to Nef protein stimulant.||||0.35
72525129|NCT02859558|144580560|SUPERIORITY|||||||0.007||||||No adjustments for multiple comparisons. P-value based on two-sided test.|Wilcoxon (Mann-Whitney)|||Null Hypothesis: There is no difference between Arm 1 and Arm 3 in percentage of HIV-1-specific CD8+ T-cells expressing any cytokine (CD40L, CD107a, IFNg, MIP1B, TNFa) in response to Nef protein stimulant.||||0.007
72525130|NCT02859558|144580560|SUPERIORITY|||||||0.045||||||No adjustments for multiple comparisons. P-value based on two-sided test.|Wilcoxon (Mann-Whitney)|||Null Hypothesis: There is no difference between Arm 2 and Arm 3 in percentage of HIV-1-specific CD8+ T-cells expressing any cytokine (CD40L, CD107a, IFNg, MIP1B, TNFa) in response to Nef protein stimulant.||||0.045
72525131|NCT02859558|144580560|SUPERIORITY|||||||0.085||||||No adjustments for multiple comparisons. P-value based on two-sided test.|Wilcoxon (Mann-Whitney)|||Null Hypothesis: There is no difference between Arm 1 and Arm 2 in percentage of HIV-1-specific CD8+ T-cells expressing any cytokine (CD40L, CD107a, IFNg, MIP1B, TNFa) in response to Pol protein stimulant.||||0.085
72625242|NCT01098747|144780081|SUPERIORITY_OR_OTHER||LS mean difference|8.16|||<|0.001|TWO_SIDED|95.0|6.66|9.66||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPID 0-6: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||9.66|6.66|<0.001
72525132|NCT02859558|144580560|SUPERIORITY|||||||0.044||||||No adjustments for multiple comparisons. P-value based on two-sided test.|Wilcoxon (Mann-Whitney)|||Null Hypothesis: There is no difference between Arm 1 and Arm 3 in percentage of HIV-1-specific CD8+ T-cells expressing any cytokine (CD40L, CD107a, IFNg, MIP1B, TNFa) in response to Pol protein stimulant.||||0.044
72525133|NCT02859558|144580560|SUPERIORITY|||||||0.6||||||No adjustments for multiple comparisons. P-value based on two-sided test.|Wilcoxon (Mann-Whitney)|||Null Hypothesis: There is no difference between Arm 2 and Arm 3 in percentage of HIV-1-specific CD8+ T-cells expressing any cytokine (CD40L, CD107a, IFNg, MIP1B, TNFa) in response to Pol protein stimulant.||||0.60
72525134|NCT02859558|144580561|SUPERIORITY|||||||1||||||No adjustments for multiple comparisons. P-value based on two-sided test.|Fisher Exact|||Results from Joint Assay. Null Hypothesis: There is no difference between Arm 1 and Arm 2 in the proportion of participants with undetectable CA-DNA.||||1
72525135|NCT02859558|144580561|SUPERIORITY|||||||1||||||No adjustments for multiple comparisons. P-value based on two-sided test.|Fisher Exact|||Results from Joint Assay. Null Hypothesis: There is no difference between Arm 2 and Arm 3 in the proportion of participants with undetectable CA-DNA.||||1
72525136|NCT02859558|144580561|SUPERIORITY|||||||0.64||||||No adjustments for multiple comparisons. P-value based on two-sided test.|Fisher Exact|||Results from Integrase Assay. Null Hypothesis: There is no difference between Arm 1 and Arm 2 in the proportion of participants with undetectable CA-DNA.||||0.64
72525137|NCT02859558|144580561|SUPERIORITY|||||||0.69||||||No adjustments for multiple comparisons. P-value based on two-sided test.|Fisher Exact|||Results from Integrase Assay. Null Hypothesis: There is no difference between Arm 1 and Arm 3 in the proportion of participants with undetectable CA-DNA.||||0.69
72525138|NCT02859558|144580561|SUPERIORITY|||||||0.4||||||No adjustments for multiple comparisons. P-value based on two-sided test.|Fisher Exact|||Results from Integrase Assay. Null Hypothesis: There is no difference between Arm 2 and Arm 3 in the proportion of participants with undetectable CA-DNA.||||0.40
72525139|NCT02859558|144580561|SUPERIORITY|||||||1||||||No adjustments for multiple comparisons. P-value based on two-sided test.|Fisher Exact|||Results from Gag Assay. Null Hypothesis: There is no difference between Arm 1 and Arm 2 in the proportion of participants with undetectable CA-DNA.||||1
72525140|NCT02859558|144580561|SUPERIORITY|||||||1||||||No adjustments for multiple comparisons. P-value based on two-sided test.|Fisher Exact|||Results from Gag Assay. Null Hypothesis: There is no difference between Arm 2 and Arm 3 in the proportion of participants with undetectable CA-DNA.||||1
72525141|NCT05665595|144580562|OTHER||Hazard Ratio (HR)|1.25|||||TWO_SIDED|95.0|0.87|1.8|||||Hazard Ratio based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by melanoma risk-based stage (IIB/IIC/clinical IIB and IIC/IIIA/IIIB vs IIIC/IIID/IV) and region of enrollment (Asia vs ROW).|||1.80|0.87|
72525142|NCT03793010|144580572|SUPERIORITY||Mean Difference (Final Values)|0.31|||||TWO_SIDED|95.0|-1.2|1.81||||||||1.81|-1.20|
72406579|NCT00689481|144321724|SUPERIORITY_OR_OTHER|||||||0.016|||||||Cochran-Mantel-Haenszel|Stratified by pooled center||||||0.016
72525143|NCT03793010|144580573|SUPERIORITY||Mean Difference (Final Values)|0.6|||||TWO_SIDED|95.0|-1.05|2.24||||||||2.24|-1.05|
72525144|NCT03793010|144580574|SUPERIORITY||Mean Difference (Final Values)|0.0|||||TWO_SIDED|95.0|-1.0|0.9||||||||0.9|-1.0|
72525145|NCT05032755|144580603|SUPERIORITY||beta estimate|1.902|STANDARD_ERROR_OF_MEAN|0.398|<|0.0001|TWO_SIDED||||||Mixed Models Analysis|Model includes random intercepts|Estimation parameter is beta estimate for group by visit interaction term|||||<.0001
72525146|NCT05032755|144580604|SUPERIORITY||beta estimate|0.368|STANDARD_ERROR_OF_MEAN|0.08|<|0.0001|TWO_SIDED|||||Group is entered as a between-subjects factor and Visit is included as a repeated factor with 5 levels. Baseline pain and FTCD scores, assessed at screening, are included along with sex as covariates.|Mixed Models Analysis|Model includes random intercepts|Estimation parameter is beta estimate for group by visit interaction term.|||||<.0001
72525147|NCT05032755|144580605|SUPERIORITY||beta estimate|0.672|STANDARD_ERROR_OF_MEAN|0.362||0.065|TWO_SIDED|||||Group is entered as a between-subjects factor and Visit is included as a repeated factor with 5 levels. Baseline pain and FTCD scores, assessed at screening, are included along with sex as covariates.|Mixed Models Analysis|Model includes random intercepts|Estimation parameter is beta estimate for group by visit interaction term.|||||0.065
72525148|NCT05032755|144580606|SUPERIORITY||beta estimate|0.364|STANDARD_ERROR_OF_MEAN|0.133||0.007|TWO_SIDED|||||Group is entered as a between-subjects factor and Visit is included as a repeated factor with 5 levels. Baseline pain and FTCD scores, assessed at screening, are included along with sex as covariates.|Mixed Models Analysis|Model includes random intercepts|Estimation parameter is beta estimate for group by visit interaction term.|||||0.007
72525149|NCT05032755|144580607|SUPERIORITY||beta estimate|1.78|STANDARD_ERROR_OF_MEAN|1.78||0.325|TWO_SIDED|||||Group is entered as a between-subjects factor and Visit is included as a repeated factor with 2 levels (pre- vs post-intervention). Baseline pain and FTCD scores, assessed at screening, are included along with sex as covariates.|Mixed Models Analysis|Model includes random intercepts|Estimation parameter is beta estimate for group by visit interaction term.|||||0.325
72525150|NCT05032755|144580609|SUPERIORITY||beta estimate|0.222|STANDARD_ERROR_OF_MEAN|0.104||0.035|TWO_SIDED|||||Group is entered as a between-subjects factor and Visit is included as a repeated factor with 5 levels. Baseline pain and FTCD scores, assessed at screening, are included along with sex as covariates.|Mixed Models Analysis|Model includes random intercepts|Estimation parameter is beta estimate for group by visit interaction term.|||||0.035
72525151|NCT05032755|144580610|SUPERIORITY||beta estimate|0.201|STANDARD_ERROR_OF_MEAN|0.181||0.27|TWO_SIDED|||||Group is entered as a between-subjects factor and Visit is included as a repeated factor with 5 levels. Baseline pain and FTCD scores, assessed at screening, are included along with sex as covariates.|Mixed Models Analysis|Model includes random intercepts|Estimation parameter is beta estimate for group by visit interaction term.|||||0.27
72406580|NCT00689481|144321724|SUPERIORITY_OR_OTHER|||||||0.843|||||||Breslow-Day test|Breslow-Day test of the homogeneity of the odds ratio using a 0.1 significance level.||Consistency of results across investigative centers was verified using the Breslow-Day test of homogeneity the odds ration using a significance level of 0.1||||0.843
72406581|NCT00689481|144321725|SUPERIORITY_OR_OTHER|||||||0.034|||||||Cochran-Mantel-Haenszel|Stratified by pooled center||||||0.034
72525152|NCT05032755|144580611|SUPERIORITY||beta estimate|-1.229|STANDARD_ERROR_OF_MEAN|1.037||0.24|TWO_SIDED|||||Group is entered as a between-subjects factor and Visit is included as a repeated factor with 5 levels. Baseline pain and FTCD scores, assessed at screening, are included along with sex as covariates.|Mixed Models Analysis|Model includes random intercepts|Estimation parameter is beta estimate for group by visit interaction term.|||||0.24
72525153|NCT05032755|144580616|SUPERIORITY||beta estimate|4.69|STANDARD_ERROR_OF_MEAN|2.88||0.113|TWO_SIDED|||||Group is entered as a between-subjects factor and Visit is included as a repeated factor with 2 levels (pre- vs post-intervention). Baseline pain and FTCD scores, assessed at screening, are included along with sex as covariates.|Mixed Models Analysis|Model includes random intercepts|Estimation parameter is beta estimate for group by visit interaction term.|||||0.113
72525154|NCT01874353|144580627|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.3|||<|0.0001|TWO_SIDED|95.0|0.22|0.41||Determined using a log-rank test stratified by response to previous platinum chemotherapy and time to disease progression in the penultimate platinum based chemotherapy prior to enrolment|Regression, Cox|Model includes factors for response to previous platinum chemotherapy and time to disease progression in the penultimate platinum based chemotherapy|A hazard ratio \< 1 favours olaparib|||0.41|0.22|<0.0001
72525155|NCT01874353|144580627|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.44|||||TWO_SIDED|95.0|0.17|1.19||Not applicable, due to small sample size. China cohort designed to provide descriptive analysis only.|Regression, Cox|Model includes a treatment factor only|A hazard ratio \< 1 favours olaparib|||1.19|0.17|
72525156|NCT01874353|144580628|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.74||||0.0537|TWO_SIDED|95.0|0.54|1.0||Determined using a log-rank test stratified by response to previous platinum chemotherapy and time to disease progression in the penultimate platinum based chemotherapy prior to enrolment|Regression, Cox|Model includes factors for response to previous platinum chemotherapy and time to disease progression in the penultimate platinum based chemotherapy|A hazard ratio \<1 favours olaparib|||1.00|0.54|0.0537
72525157|NCT01874353|144580628|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.93|||||TWO_SIDED|95.0|0.38|2.49||Not applicable, due to small sample size. China cohort designed to provide descriptive analysis only.|Regression, Cox|Model includes a treatment factor only|A hazard ratio \<1 favours olaparib|||2.49|0.38|
72525158|NCT01874353|144580629|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.3|||<|0.0001|TWO_SIDED|95.0|0.23|0.41||Determined using a log-rank test stratified by response to previous platinum chemotherapy and time to disease progression in the penultimate platinum based chemotherapy prior to enrolment|Regression, Cox|Model includes factors for response to previous platinum chemotherapy and time to disease progression in the penultimate platinum based chemotherapy|A hazard ratio \< 1 favours olaparib|||0.41|0.23|<0.0001
72525159|NCT01874353|144580629|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.41|||||TWO_SIDED|95.0|0.18|1.03||Not applicable, due to small sample size. China cohort designed to provide descriptive analysis only.|Regression, Cox|Model includes a treatment factor only|A hazard ratio \<1 favours olaparib|||1.03|0.18|
72525160|NCT01874353|144580630|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.5||||0.0002|TWO_SIDED|95.0|0.34|0.72||Determined using a log-rank test stratified by response to previous platinum chemotherapy and time to disease progression in the penultimate platinum based chemotherapy prior to enrolment|Regression, Cox|Model includes factors for response to previous platinum chemotherapy and time to disease progression in the penultimate platinum based chemotherapy|A hazard ratio \< 1 favours olaparib|||0.72|0.34|0.0002
72525161|NCT01874353|144580630|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.84|||||TWO_SIDED|95.0|0.22|3.97||Not applicable, due to small sample size. China cohort designed to provide descriptive analysis only.|Regression, Cox|Model includes treatment factor only|A hazard ratio \< 1 favours olaparib|||3.97|0.22|
72525162|NCT01874353|144580631|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.03||||0.9765|TWO_SIDED|95.0|-2.191|2.126|||Mixed Models Analysis|Fixed effects for treatment, visit and baseline TOI with the treatment by visit and baseline TOI by visit interaction. Random patient effect.||||2.126|-2.191|0.9765
72525163|NCT01874353|144580632|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.37|||<|0.0001|TWO_SIDED|95.0|0.28|0.48||Determined using a log-rank test stratified by response to previous platinum chemotherapy and time to disease progression in the penultimate platinum based chemotherapy prior to enrolment|Regression, Cox|Model includes factors for response to previous platinum chemotherapy and time to disease progression in the penultimate platinum based chemotherapy|A hazard ratio \< 1 favours olaparib|||0.48|0.28|<0.0001
72525164|NCT01874353|144580632|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.47|||||TWO_SIDED|95.0|0.21|1.08||Not applicable, due to small sample size. China cohort designed to provide descriptive analysis only.|Regression, Cox|Model includes a treatment factor only|A hazard ratio \< 1 favours olaparib|||1.08|0.21|
72571106|NCT01941940|144670500|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Rank Sum and Signed Rank Tests|||Analysis for change from baseline to Week 52 was performed using Wilcoxon Rank Sum and Signed Rank Tests for dependent sample.||||<0.0001
72571107|NCT01941940|144670501|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Rank Sum and Signed Rank Tests|||Analysis for change from baseline to Week 2 was performed using Wilcoxon Rank Sum and Signed Rank Tests for dependent sample.||||<0.0001
72571108|NCT01941940|144670501|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Rank Sum and Signed Rank Tests|||Analysis for change from baseline to Week 24 was performed using Wilcoxon Rank Sum and Signed Rank Tests for dependent sample.||||<0.0001
72571109|NCT01941940|144670501|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Rank Sum and Signed Rank Tests|||Analysis for change from baseline to Week 52 was performed using Wilcoxon Rank Sum and Signed Rank Tests for dependent sample.||||<0.0001
72571110|NCT01941940|144670502|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Rank Sum and Signed Rank Tests|||Analysis for change from baseline to Week 2 was performed using Wilcoxon Rank Sum and Signed Rank Tests for dependent sample.||||<0.0001
72571111|NCT01941940|144670502|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Rank Sum and Signed Rank Tests|||Analysis for change from baseline to Week 24 was performed using Wilcoxon Rank Sum and Signed Rank Tests for dependent sample.||||<0.0001
72525165|NCT01874353|144580633|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.51|||<|0.0001|TWO_SIDED|95.0|0.39|0.68||Determined using a log-rank test stratified by response to previous platinum chemotherapy and time to disease progression in the penultimate platinum based chemotherapy prior to enrolment|Regression, Cox|Model includes factors for response to previous platinum chemotherapy and time to disease progression in the penultimate platinum based chemotherapy|A hazard ratio \< 1 favours olaparib|||0.68|0.39|<0.0001
72525166|NCT01874353|144580633|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.81|||||TWO_SIDED|95.0|0.37|1.85||Not applicable, due to small sample size. China cohort designed to provide descriptive analysis only.|Regression, Cox|Model included treatment factor only|A hazard ratio \< 1 favours olaparib|||1.85|0.37|
72525167|NCT01874353|144580634|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.37|||<|0.0001|TWO_SIDED|95.0|0.28|0.49||Determined using a log-rank test stratified by response to previous platinum chemotherapy and time to disease progression in the penultimate platinum based chemotherapy prior to enrolment|Regression, Cox|Model includes factors for response to previous platinum chemotherapy and time to disease progression in the penultimate platinum based chemotherapy|A hazard ratio \< 1 favours olaparib|||0.49|0.28|<0.0001
72525168|NCT01874353|144580634|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.45|||||TWO_SIDED|95.0|0.2|1.04||Not applicable, due to small sample size. China cohort designed to provide descriptive analysis only.|Regression, Cox|Model includes a treatment factor only|A hazard ratio \< 1 favours the Olaparib arm|||1.04|0.20|
72525169|NCT01874353|144580635|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.3|||<|0.0001|TWO_SIDED|95.0|0.22|0.4||Determined using a log-rank test stratified by response to previous platinum chemotherapy and time to disease progression in the penultimate platinum based chemotherapy prior to enrolment|Regression, Cox|Model includes factors for response to previous platinum chemotherapy and time to disease progression in the penultimate platinum based chemotherapy|A hazard ratio \< 1 favours olaparib|||0.40|0.22|<0.0001
72525170|NCT03797144|144580656|OTHER|"A paired t-test for normally distributed data was performed to test whether the mean improvement from baseline was significantly greater than 0.~The normality of the data distribution was assessed with the Shapiro-Wilk test."||||||0.06|||||||t-test, 1 sided|||"To verify that the improvement of ODI from Baseline to 3 Month was significantly greater than 0 for each indication subgroup the following statistical analyses were planned.~The null hypothesis was H0: μ\_ODI ≤ 0, and the alternative hypothesis was Ha: μ\_ODI \> 0 where μ\_ODI is the mean improvement of ODI score at 3 months from baseline."||||0.06
72525171|NCT03797144|144580656|OTHER|"A paired t-test for normally distributed data was performed to test whether the mean improvement from baseline was significantly greater than 0.~The normality of the data distribution was assessed with the Shapiro-Wilk test."||||||0.012|||||||t-test, 1 sided|||"To verify that the improvement of ODI from Baseline to 3 Month was significantly greater than 0 for each indication subgroup the following statistical analyses were planned.~The null hypothesis was H0: μ\_ODI ≤ 0, and the alternative hypothesis was Ha: μ\_ODI \> 0 where μ\_ODI is the mean improvement of ODI score at 3 months from baseline."||||0.012
72525172|NCT03797144|144580657|OTHER|"A paired t-test for normally distributed data was performed to test whether the mean improvement from baseline was significantly greater than 0.~The normality of the data distribution was assessed with the Shapiro-Wilk test."||||||0.002||||||Back Pain|t-test, 1 sided|||"To verify that the improvement of VAS from Baseline to 3 Month was significantly greater than 0 for each indication subgroup the following statistical analyses were planned.~The null hypothesis was H0: μ\_VAS ≤ 0, and the alternative hypothesis was Ha: μ\_VAS \> 0 where μ\_VAS is the mean improvement of VAS score at 3 months from baseline."||||0.002
72525173|NCT03797144|144580657|OTHER|"A paired t-test for normally distributed data was performed to test whether the mean improvement from baseline was significantly greater than 0.~The normality of the data distribution was assessed with the Shapiro-Wilk test."|||||<|0.001||||||Back Pain|t-test, 1 sided|||"To verify that the improvement of VAS from Baseline to 3 Month was significantly greater than 0 for each indication subgroup the following statistical analyses were planned.~The null hypothesis was H0: μ\_VAS ≤ 0, and the alternative hypothesis was Ha: μ\_VAS \> 0 where μ\_VAS is the mean improvement of VAS score at 3 months from baseline."||||<0.001
72571112|NCT01941940|144670502|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Rank Sum and Signed Rank Tests|||Analysis for change from baseline to Week 52 was performed using Wilcoxon Rank Sum and Signed Rank Tests for dependent sample.||||<0.0001
72525174|NCT03797144|144580657|OTHER|"A paired t-test for normally distributed data was performed to test whether the mean improvement from baseline was significantly greater than 0.~The normality of the data distribution was assessed with the Shapiro-Wilk test."|||||<|0.001||||||Leg Pain|t-test, 1 sided|||"To verify that the improvement of VAS from Baseline to 3 Month was significantly greater than 0 for each indication subgroup the following statistical analyses were planned.~The null hypothesis was H0: μ\_VAS ≤ 0, and the alternative hypothesis was Ha: μ\_VAS \> 0 where μ\_VAS is the mean improvement of VAS score at 3 months from baseline."||||<0.001
72542567|NCT01120600|144614971|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|2.12|||<|0.001|TWO_SIDED|95.0|0.93|3.3|||cLDA|||A cLDA method was used for this statistical analysis. The cLDA model included the baseline measurement and all post-baseline percent changes from baseline in the response vector, with fixed effects for treatment, time, geographic region, machine type and treatment-by-time interaction, geographic region-by-time interaction, and machine type-by-time interaction.||3.3|0.93|< 0.001
72542568|NCT01120600|144614972|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-76.58|||<|0.001|TWO_SIDED|95.0|-92.56|-60.61|||cLDA|||A cLDA method was used for this statistical analysis. The cLDA model included the baseline measurement and all post-baseline percent changes from baseline in the response vector, with fixed effects for treatment, time, geographic region, machine type and treatment-by-time interaction, geographic region-by-time interaction, and machine type-by-time interaction.||-60.61|-92.56|< 0.001
72406582|NCT00689481|144321726|SUPERIORITY_OR_OTHER|||||||0.004||||||P-value is significant based on the Holm stepwise closed testing procedure to control multiplicity for the key secondary analyses if primary analysis was significant.|Cochran-Mantel-Haenszel|Stratified by pooled center.||||||0.004
72406583|NCT00689481|144321727|SUPERIORITY_OR_OTHER|||||||0.052|||||||Cochran-Mantel-Haenszel|Stratified by pooled center||||||0.052
72525175|NCT03797144|144580657|OTHER|"A paired t-test for normally distributed data was performed to test whether the mean improvement from baseline was significantly greater than 0.~The normality of the data distribution was assessed with the Shapiro-Wilk test."|||||<|0.001||||||Leg Pain|t-test, 1 sided|||"To verify that the improvement of VAS from Baseline to 3 Month was significantly greater than 0 for each indication subgroup the following statistical analyses were planned.~The null hypothesis was H0: μ\_VAS ≤ 0, and the alternative hypothesis was Ha: μ\_VAS \> 0 where μ\_VAS is the mean improvement of VAS score at 3 months from baseline."||||<0.001
72525176|NCT03797144|144580658|OTHER|"A paired t-test for normally distributed data was performed to test whether the mean improvement from baseline was significantly greater than 0.~The normality of the data distribution was assessed with the Shapiro-Wilk test."||||||0.174||||||Health State Score|t-test, 1 sided|||"To verify that the improvement of EQ-5D 5L from Baseline to 3 Month was significantly greater than 0 for each indication subgroup the following statistical analyses were planned.~The null hypothesis was H0: μ\_EQ-5D 5L ≤ 0, and the alternative hypothesis was Ha: μ\_EQ-5D 5L \> 0 where μ\_EQ-5D 5L is the mean improvement of EQ-5D 5L score at 3 months from baseline."||||0.174
72525177|NCT03797144|144580658|OTHER|"A paired t-test for normally distributed data was performed to test whether the mean improvement from baseline was significantly greater than 0.~The normality of the data distribution was assessed with the Shapiro-Wilk test."||||||0.002||||||Health State Score|t-test, 1 sided|||"To verify that the improvement of EQ-5D 5L from Baseline to 3 Month was significantly greater than 0 for each indication subgroup the following statistical analyses were planned.~The null hypothesis was H0: μ\_EQ-5D 5L ≤ 0, and the alternative hypothesis was Ha: μ\_EQ-5D 5L \> 0 where μ\_EQ-5D 5L is the mean improvement of EQ-5D 5L score at 3 months from baseline."||||0.002
72525178|NCT03797144|144580658|OTHER|"A paired t-test for normally distributed data was performed to test whether the mean improvement from baseline was significantly greater than 0.~The normality of the data distribution was assessed with the Shapiro-Wilk test."||||||0.003||||||Index score|t-test, 1 sided|||"To verify that the improvement of EQ-5D 5L from Baseline to 3 Month was significantly greater than 0 for each indication subgroup the following statistical analyses were planned.~The null hypothesis was H0: μ\_EQ-5D 5L ≤ 0, and the alternative hypothesis was Ha: μ\_EQ-5D 5L \> 0 where μ\_EQ-5D 5L is the mean improvement of EQ-5D 5L score at 3 months from baseline."||||0.003
72525179|NCT03797144|144580658|OTHER|"A paired t-test for normally distributed data was performed to test whether the mean improvement from baseline was significantly greater than 0.~The normality of the data distribution was assessed with the Shapiro-Wilk test."||||||0.012||||||Index score|t-test, 1 sided|||"To verify that the improvement of EQ-5D 5L from Baseline to 3 Month was significantly greater than 0 for each indication subgroup the following statistical analyses were planned.~The null hypothesis was H0: μ\_EQ-5D 5L ≤ 0, and the alternative hypothesis was Ha: μ\_EQ-5D 5L \> 0 where μ\_EQ-5D 5L is the mean improvement of EQ-5D 5L score at 3 months from baseline."||||0.012
72525180|NCT01526928|144580685|OTHER||||||||||||||||||Since an MTD was never reached for any of the rociletinib FB or HBr formulations/doses, a 750 mg BID HBr starting dose was selected based on early efficacy data from Phase 1, and enrollment into Phase 2 was initiated at this dosage. As the Phase 1 efficacy data matured, the recommended dose was adjusted to 625 mg BID based on antitumor activity and safety evaluations.|||
72525181|NCT01108068|144580700|EQUIVALENCE|Continuous variables were expressed as means ± SD or median (range). Group differences in pQCT Z-scores according to genotype T-test was used to compare differences at baseline between affecteds and unaffecteds||||||0.0003|||||||t-test, 1 sided|Differences in the two groups were assessed using Student's t-test or the rank-sum test if skewed.||Cortical area Z-score||||0.0003
72525182|NCT01108068|144580700|EQUIVALENCE|Continuous variables were expressed as means ± SD or median (range). Group differences in pQCT Z-scores according to genotype||||||0.001|||||||t-test, 1 sided|Differences in the two groups were assessed using Student's t-test or the rank-sum test if skewed.||Periosteal circumference Z-score||||0.001
72525183|NCT00376675|144580705|SUPERIORITY_OR_OTHER|||||||0.317|||||||Wilcoxon rank sum test|||||||0.317
72525184|NCT00995215|144580715|OTHER|Statistical analysis was performed using a repeated measures analysis of variance and paired t-test.||||||0.05||||||A P value \<0.05 was taken as indicative of statistical significance.|ANOVA|||The effects of electrical (spinal cord stimulation) SCS with disc electrode and wire leads on airway pressure generation were compared. Since SCS with the disc leads, when applied in clinical trials, resulted in airway pressure generation that approximated pressures generated with a normal maximum cough, airway pressure generation achieved during SCS with these leads served as our gold standard to which all comparisons were made.||||0.05
72525185|NCT01332851|144580750|SUPERIORITY||Cox Proportional Hazard|2.5|||=|0.043|TWO_SIDED|95.0|1.03|6.1||We used a threshold of p \< .05 as the criterion for statistical significance.|Regression, Cox||The hazard ratio of 2.5 indicates that children with parents in the control group were 2.5 times more likely to be removed from their home and placed into foster care compared to the intervention group.|Child welfare system removals were analyzed with a survival models that used condition assignment to predict hazard of being removed from the birth parent home.||6.10|1.03|=.043
72525186|NCT01332851|144580751|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.94|STANDARD_ERROR_OF_MEAN|0.42|<|0.05|TWO_SIDED||||||Mixed Models Analysis||Parents in the PFR condition were 0.94 higher on sensitivity scores (on the unstandardized sensitivity measure) across the three post-intervention time points than parents in the R\&R condition. The standard error (SE) of this difference was .42.|Mixed models were estimated in which post-intervention scores were nested. The intercept (representing the average score across post-intervention time points) was modeled as having a random effect. The intercept in the mixed model was regressed on intervention condition (R\&R = 0, PFR = 1), baseline sensitivity score, months between baseline and end of intervention, and age of child at baseline.||||<.05
72571113|NCT01941940|144670504|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Rank Sum and Signed Rank Tests|||Analysis for change from baseline to Week 2 was performed using Wilcoxon Rank Sum and Signed Rank Tests for dependent sample.||||<0.0001
72571114|NCT01941940|144670504|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Rank Sum and Signed Rank Tests|||Analysis for change from baseline to Week 24 was performed using Wilcoxon Rank Sum and Signed Rank Tests for dependent sample.||||<0.0001
72406584|NCT00689481|144321728|SUPERIORITY_OR_OTHER|||||||0.033|||||||Cochran-Mantel-Haenszel|Stratified by pooled center||||||0.033
72625243|NCT01098747|144780081|SUPERIORITY_OR_OTHER||LS mean difference|-0.23||||0.679|TWO_SIDED|95.0|-1.31|0.85||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPID 0-6: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.85|-1.31|0.679
72406585|NCT00689481|144321729|SUPERIORITY_OR_OTHER|||||||0.859|||||||Cochran-Mantel-Haenszel|Stratified by pooled center||Comparison of calcipotriene foam and vehicle foam for patients who had mild disease at baseline||||0.859
72406586|NCT00689481|144321729|SUPERIORITY_OR_OTHER|||||||0.015|||||||Cochran-Mantel-Haenszel|Stratified by pooled center||Comparison of calcipotriene foam and vehicle foam for patients who had moderate disease at baseline||||0.015
72406587|NCT06425458|144321734|OTHER|||||||0.0011||||||Threshold for statistical significance: P \<= 0.05. As this was an exploratory analysis only, p-values were not adjusted for multiple comparisons.|t-test, 2 sided|||Paired t-tests were conducted to compare T1 and T2 Self-Esteem (MAPS20 subscale) scores. This analysis included participants who completed both T1 and T2 data collection (n = 18).||||0.0011
72525187|NCT01332851|144580752|SUPERIORITY||Mean Difference (Net)|0.05|STANDARD_ERROR_OF_MEAN|0.03|>|0.05|TWO_SIDED||||||Mixed Models Analysis||The PFR group had a higher mean compared to the R\&R group. (the absolute value of the standardized effect is d=.15).|Mixed models were estimated in which post-intervention scores were nested. The intercept (representing the average score across post-intervention time points) was modeled as having a random effect. The intercept in the mixed model was regressed on intervention condition (R\&R = 0, PFR = 1), baseline security score, months between baseline and end of intervention, and age of child at baseline||||>.05
72525188|NCT01332851|144580753|SUPERIORITY||Mean Difference (Net)|-0.2|STANDARD_ERROR_OF_MEAN|0.5|>|0.05|TWO_SIDED||||||Mixed Models Analysis||The adjusted mean across the two post-intervention time points was -.20 (SE=.50) lower in the PFR group than R\&R group. The standardized effect size was d=.04.|Mixed models were estimated in which post-intervention scores were nested. The intercept (representing the average score across post-intervention time points) was modeled as having a random effect. The intercept in the mixed model was regressed on intervention condition (R\&R = 0, PFR = 1), baseline problem behavior score, months between baseline and end of intervention, and age of child at baseline.||||>.05
72406588|NCT06425458|144321734|OTHER|||||||0.0719||||||Threshold for statistical significance: P \<= .05. As this was an exploratory analysis only, p-values were not adjusted for multiple comparisons.|t-test, 2 sided|||Paired t-tests were conducted to compare T1 and T2 Purpose in Life (MAPS20 subscale) scores. This analysis included participants who completed both T1 and T2 data collection (n = 18).||||0.0719
72406589|NCT06425458|144321734|OTHER|||||||0.7991||||||Threshold for statistical significance: P \<= .05. As this was an exploratory analysis only, p-values were not adjusted for multiple comparisons.|t-test, 2 sided|||Paired t-tests were conducted to compare T1 and T2 Locus of Control (MAPS20 subscale) scores. This analysis included participants who completed both T1 and T2 data collection (n = 18).||||0.7991
72525189|NCT01332851|144580754|SUPERIORITY||Mean Difference (Net)|0.41|STANDARD_ERROR_OF_MEAN|0.53|>|0.05|TWO_SIDED||||||Mixed Models Analysis||The adjusted mean across post-intervention time points was .41 (SE=.53) higher in the PFR group than the R\&R group. The standardized effect size was d=-.07|Mixed models were estimated in which post-intervention scores were nested. The intercept (representing the average score across post-intervention time points) was modeled as having a random effect. The intercept in the mixed model was regressed on intervention condition (R\&R = 0, PFR = 1), baseline competence stress score, months between baseline and end of intervention, and age of child at baseline||||>.05
72525190|NCT01332851|144580755|SUPERIORITY||Mean Difference (Net)|0.24|STANDARD_ERROR_OF_MEAN|0.25|>|0.05|TWO_SIDED||||||Mixed Models Analysis||The PFR group had a higher mean level of social and emotional development compared to the R\&R group (the absolute value of the standardized effect is d=.10).|Mixed models were estimated in which post-intervention scores were nested. The intercept (representing the average score across post-intervention time points) was modeled as having a random effect. The intercept in the mixed model was regressed on intervention condition (R\&R = 0, PFR = 1), baseline social-emotional competence score, months between baseline and end of intervention, and age of child at baseline.||||>.05
72542569|NCT01120600|144614973|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-68.08|||<|0.001|TWO_SIDED|95.0|-78.1|-58.06|||cLDA|||A cLDA method was used for this statistical analysis. The cLDA model included the baseline measurement and all post-baseline percent changes from baseline in the response vector, with fixed effects for treatment, time, geographic region, machine type and treatment-by-time interaction, geographic region-by-time interaction, and machine type-by-time interaction.||-58.06|-78.1|< 0.001
72625244|NCT01098747|144780081|SUPERIORITY_OR_OTHER||LS mean difference|9.94|||<|0.001|TWO_SIDED|95.0|7.92|11.96||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPID 0-8: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||11.96|7.92|<0.001
72406590|NCT06425458|144321734|OTHER|||||||0.2208||||||Threshold for statistical significance: P \<= .05. As this was an exploratory analysis only, p-values were not adjusted for multiple comparisons.|t-test, 2 sided|||Paired t-tests were conducted to compare T1 and T2 Self-Efficacy (MAPS20 subscale) scores. This analysis included participants who completed both T1 and T2 data collection (n = 18).||||0.2208
72406591|NCT06425458|144321734|OTHER||Spearman partial correlation coefficient|0.37|||||TWO_SIDED|||||||||We conducted an exploratory, descriptive analysis investigating the relationship between leadership program attendance and identity capital at T2, accounting for T1 scores (MAPS20 subscale: Self-Esteem). This analysis included participants who completed both T1 and T2 data collection (n = 18). We calculated the Spearman correlation coefficient only. Power calculation does not apply for this analysis.||||
72406592|NCT06425458|144321734|OTHER||Spearman partial correlation coefficient|-0.29|||||TWO_SIDED|||||||||We conducted an exploratory, descriptive analysis investigating the relationship between leadership program attendance and identity capital at T2, accounting for T1 scores (MAPS20 subscale: Purpose in Life). This analysis included participants who completed both T1 and T2 data collection (n = 18). We calculated the Spearman correlation coefficient only. Power calculation does not apply for this analysis.||||
72525191|NCT01332851|144580756|SUPERIORITY||Mean Difference (Net)|-0.8|STANDARD_ERROR_OF_MEAN|0.66|>|0.05|TWO_SIDED||||||Mixed Models Analysis||The PFR group had lower mean level of problem behavior compared to the R\&R group (the absolute value of standardized effect is d= .12).|Mixed models were estimated in which post-intervention scores were nested. The intercept (representing the average score across post-intervention time points) was modeled as having a random effect. The intercept in the mixed model was regressed on intervention condition (R\&R = 0, PFR = 1), baseline problem behavior score, months between baseline and end of intervention, and age of child at baseline||||>.05
72525192|NCT01332851|144580757|SUPERIORITY||Mean Difference (Net)|-0.07|STANDARD_ERROR_OF_MEAN|0.08|>|0.05|TWO_SIDED||||||Regression, Linear||Adjusted mean at 3-month post-intervention was -.07 (SE=.08) lower for PFR compared to R\&R group.|Tested mean differences by condition at 3-month follow-up controlling for baseline score, months between baseline and the end of the intervention, and age of child and using an ANVOVA/regression model. Null hypothesis was that post-intervention means were equal.||||>.05
72525193|NCT01332851|144580758|SUPERIORITY||Mean Difference (Net)|-0.06|STANDARD_ERROR_OF_MEAN|0.08|>|0.05|TWO_SIDED||||||Regression, Linear||Adjusted mean at 3-month post-intervention was -.06 (SE=.08) lower for PFR compared to R\&R group.|||||>.05
72525194|NCT01332851|144580759|SUPERIORITY||Mean Difference (Net)|-0.07|STANDARD_ERROR_OF_MEAN|0.04|<|0.05|TWO_SIDED||||||Mixed Models Analysis||The PFR group had lower atypical affective communication compared to the R\&R group (the absolute value of the standardized effect size was d=.19).|Mixed models were estimated in which post-intervention scores were nested. The intercept (representing the average score across post-intervention time points) was modeled as having a random effect. The intercept in the mixed model was regressed on intervention condition (R\&R = 0, PFR = 1), baseline score, months between baseline and end of intervention, and age of child at baseline||||<.05
72525195|NCT00255008|144580764|SUPERIORITY_OR_OTHER||Proportion of patients (%)|80.0||||||95.0|28.36|99.49||||||||99.49|28.36|
72525196|NCT00255008|144580764|SUPERIORITY_OR_OTHER||Proportion of patients (%)|76.47||||||95.0|50.1|93.19||||||||93.19|50.10|
72525197|NCT00255008|144580764|SUPERIORITY_OR_OTHER||Proportion of patients (%)|87.5||||||95.0|47.35|99.48||||||||99.48|47.35|
72525198|NCT02996500|144580765|SUPERIORITY||Mean Difference (Net)|-7.83||||0.005|TWO_SIDED|95.0|-13.73|-1.97|||ANCOVA|Bayesian analysis of covariance (ANCOVA) modeling framework was used with baseline SDAI score as a covariate.||The confidence interval was credible interval in this analysis.||-1.97|-13.73|0.0050
72525199|NCT02996500|144580765|SUPERIORITY||Mean Difference (Net)|-8.96|||<|0.001|TWO_SIDED|95.0|-14.37|-3.66|||ANCOVA|Bayesian analysis of covariance (ANCOVA) modeling framework was used with baseline SDAI score as a covariate.||The confidence interval was credible interval in this analysis.||-3.66|-14.37|<0.001
72525200|NCT02996500|144580765|SUPERIORITY||Median Difference (Net)|-10.89|||<|0.001|TWO_SIDED|95.0|-16.36|-5.63|||ANCOVA|Bayesian analysis of covariance (ANCOVA) modeling framework was used with baseline SDAI score as a covariate.||The confidence interval was credible interval in this analysis.||-5.63|-16.36|<0.001
72525201|NCT02996500|144580765|SUPERIORITY||Mean Difference (Net)|-11.29|||<|0.001|TWO_SIDED|95.0|-16.62|-5.92|||ANCOVA|Bayesian analysis of covariance (ANCOVA) modeling framework was used with baseline SDAI score as a covariate.||The confidence interval was credible interval in this analysis.||-5.92|-16.62|<0.001
72525202|NCT00835276|144580801|NON_INFERIORITY_OR_EQUIVALENCE|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|87.96||||||90.0|80.15|96.53|||||To establish bioequivalence, the mean values for the test product differ by no more than 20% from the respective mean values for the reference listed product.|||96.53|80.15|
72525203|NCT00835276|144580802|NON_INFERIORITY_OR_EQUIVALENCE|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|91.47||||||90.0|85.15|98.26|||||To establish bioequivalence, the mean values for the test product differ by no more that 20% from the repective mean values for the reference listed product.|||98.26|85.15|
72525204|NCT00835276|144580803|NON_INFERIORITY_OR_EQUIVALENCE|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|91.47||||||90.0|85.32|98.07|||||To establish bioequivalence, the mean values for the test product differ by no more than 20% from the respective mean values for the reference listed product.|||98.07|85.32|
72525205|NCT02858713|144580820|SUPERIORITY||Odds Ratio (OR)|2.99|||=|0.004|TWO_SIDED|95.0|1.42|6.28|||Regression, Logistic|||||6.28|1.42|=0.004
72525206|NCT02858713|144580821|SUPERIORITY||Coefficient|-0.415|||=|0.545|TWO_SIDED|95.0|-1.77|0.939|||Regression, Linear|||DLQI: Change baseline to week 4||0.939|-1.770|=0.545
72525207|NCT02858713|144580821|SUPERIORITY||Coefficient|-0.415||||0.545|TWO_SIDED|95.0|-1.77|0.939|||Regression, Linear|||DLQI: Change from baseline to week 4||0.939|-1.770|0.545
72571115|NCT01941940|144670504|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Rank Sum and Signed Rank Tests|||Analysis for change from baseline to Week 52 was performed using Wilcoxon Rank Sum and Signed Rank Tests for dependent sample.||||<0.0001
72525208|NCT02858713|144580821|SUPERIORITY||Coefficient|-0.581||||0.45|TWO_SIDED|95.0|-2.099|0.938|||Regression, Linear|||DLQI: Change from baseline to week 8||0.938|-2.099|0.450
72525209|NCT02858713|144580821|SUPERIORITY||Coefficient|-0.77||||0.348|TWO_SIDED|95.0|-2.389|0.848|||Regression, Linear|||DLQI: Change from baseline to week 26||0.848|-2.389|0.348
72525210|NCT02858713|144580822|SUPERIORITY||coefficient|0.4||||0.047|TWO_SIDED|95.0|0.005|0.795|||Regression, Linear|||LS-PGA: Change from baseline to week 4||0.795|0.005|0.047
72525211|NCT02858713|144580822|SUPERIORITY||Coefficient|0.091||||0.662|TWO_SIDED|95.0|-0.321|0.504|||Regression, Linear|||LS-PGA: Change from baseline to week 8||0.504|-0.321|0.662
72525212|NCT02858713|144580822|SUPERIORITY||Coefficient|0.18||||0.424|TWO_SIDED|95.0|-0.264|0.625|||Regression, Linear|||LS-PGA: Change from baseline to week 26||0.625|-0.264|0.424
72525213|NCT00126425|144580826|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.44|||=|0.004|TWO_SIDED|95.0|0.23|0.83||At 0.025 level of significance.|Cox Proportional Hazards Model|||"Analysis based on Reader A readings. Data analysis to assess the relative hazard of an adverse cardiac event was performed using a Cox proportional hazards model. Hazard (risk) of an event for a participant with low H/M at time t was expressed as Hl (t)/ Hh (t) = Ψ, where Hl (t) and Hh (t) denote the hazard of an event at time t for participants with low H/M and high H/M respectively."||0.83|0.23|=0.004
72406593|NCT06425458|144321734|OTHER||Spearman partial correlation coefficient|-0.58|||||TWO_SIDED|||||||||We conducted an exploratory, descriptive analysis investigating the relationship between leadership program attendance and identity capital at T2, accounting for T1 scores (MAPS20 subscale: Locus of Control). This analysis included participants who completed both T1 and T2 data collection (n = 18). We calculated the Spearman correlation coefficient only. Power calculation does not apply for this analysis.||||
72406594|NCT06425458|144321734|OTHER||Spearman partial correlation coefficient|-0.14|||||TWO_SIDED|||||||||We conducted an exploratory, descriptive analysis investigating the relationship between leadership program attendance and identity capital at T2, accounting for T1 scores (MAPS20 subscale: Self-Efficacy). This analysis included participants who completed both T1 and T2 data collection (n = 18). We calculated the Spearman correlation coefficient only. Power calculation does not apply for this analysis.||||
72406595|NCT00445328|144321753|SUPERIORITY_OR_OTHER|||||||1||95.0||||P-value is based on chi-square test with alpha as 0.01.|Chi-squared|||||||1.0000
72406596|NCT00445328|144321755|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Chi-squared|||Major Bleeding||||1.0000
72406597|NCT00445328|144321758|SUPERIORITY_OR_OTHER|||||||0.1355||95.0|||||Chi-squared|||||||0.1355
72571116|NCT01941940|144670505|SUPERIORITY_OR_OTHER|||||||0.0045|||||||Wilcoxon Rank Sum and Signed Rank Tests|||Analysis for change from baseline to Week 24 was performed using Wilcoxon Rank Sum and Signed Rank Tests for dependent sample.||||0.0045
72406598|NCT02254278|144321759|SUPERIORITY|||||||0.04|||||||binomial|One-sided significance level=0.10||Assuming a binomial distribution, 140 eligible patients per arm were required for 80% power and 1-sided type I error rate of 10% to test the null hypothesis of 2-year progression-free survival (PFS) rate ≤ 85% against the alternative hypothesis of \> 85% with a binomial test. The arms are not compared to each other; they are each tested separately against the null hypothesis.||||0.04
72406599|NCT02254278|144321759|SUPERIORITY|||||||0.23|||||||bionmial|One-sided significance level = 0.10||Assuming a binomial distribution, 140 eligible patients per arm were required for 80% power and 1-sided type I error rate of 10% to test the null hypothesis of 2-year PFS rate ≤ 85% against the alternative hypothesis of \> 85% with a binomial test. The arms are not compared to each other; they are each tested separately against the null hypothesis.||||0.23
72406600|NCT02254278|144321760|SUPERIORITY||Hazard Ratio (HR)|0.39||||0.02|TWO_SIDED|95.0|0.17|0.9|||Log Rank|Two-sided significance level = 0.05|Reference level = IMRT 5 weeks|||0.90|0.17|0.02
72571117|NCT01941940|144670505|SUPERIORITY_OR_OTHER|||||||0.1992|||||||Wilcoxon Rank Sum and Signed Rank Tests|||Analysis for change from baseline to Week 52 was performed using Wilcoxon Rank Sum and Signed Rank Tests for dependent sample.||||0.1992
72571118|NCT00513682|144670513|SUPERIORITY_OR_OTHER|||||||0.0013||95.0|||||t-test, 1 sided|||||||0.0013
72571119|NCT00513682|144670514|SUPERIORITY_OR_OTHER|||||||0.0009||95.0|||||t-test, 1 sided|||||||0.0009
72571120|NCT02450526|144670515|SUPERIORITY|The model includes treatment group, stratification factors, gender and baseline severity score of glabellar lines at maximum frown measured by the ILA, and centre as explanatory variables and responder (Yes or No) as response variable.|Treatment difference|94.3|||<|0.0001|TWO_SIDED|95.0|90.8|97.7||The test is two-sided at the significance level of 0.025.|Regression, Logistic|||Superiority analysis of Dysport® to placebo was tested using a multivariate logistic regression model.||97.7|90.8|<0.0001
72571121|NCT02450526|144670516|SUPERIORITY|The model includes treatment group, stratification factors, gender and baseline severity score of glabellar lines at maximum frown measured by the ILA, and centre as explanatory variables and responder (Yes or No) as response variable.|Treatment difference|87.5|||<|0.0001|TWO_SIDED|95.0|82.5|92.4||The test is two-sided at the significance level of 0.025.|Regression, Logistic|||Superiority analysis of Dysport® to placebo was tested using a multivariate logistic regression model.||92.4|82.5|<0.0001
72571122|NCT02450526|144670517|NON_INFERIORITY|The model includes treatment group, stratification factors, gender and baseline severity score of glabellar lines at maximum frown measured by the ILA, and centre as explanatory variables and responder (Yes or No) as response variable.|Treatment Difference|-2.4|||||TWO_SIDED|95.0|-6.7|1.9||||||The non-inferiority of Dysport® to Botox on the ILA at maximum frown was tested using a multivariate logistic regression model||1.9|-6.7|
72571123|NCT02450526|144670518|SUPERIORITY|The model includes treatment group, stratification factors, gender and baseline severity score of glabellar lines at maximum frown measured by the ILA and centre as explanatory variables and responder (Yes or No) as response variable.|Treatment difference|73.8|||<|0.0001|TWO_SIDED|95.0|59.1|88.4|||Regression, Logistic|||Superiority analysis of Dysport® to placebo was tested using a multivariate logistic regression model.||88.4|59.1|<0.0001
72571124|NCT02450526|144670519|SUPERIORITY|The comparison between mean scores of SGA at Treatment Cycle 1, Day 29 is based on 2 separate linear mixed models, adjusting on the two stratification parameters, gender and baseline ILA severity score, and the centre.|Treatment Difference|2.603|||<|0.0001|TWO_SIDED|95.0|2.327|2.878||The test was two-sided at the significance level of 0.05|Mixed Models Analysis|||Superiority analysis of Dysport® to placebo was tested using a linear mixed model.||2.878|2.327|<0.0001
72571125|NCT02450526|144670520|SUPERIORITY|The model includes treatment group, stratification factors, gender and baseline severity score of glabellar lines at maximum frown measured by the ILA, and centre as explanatory variables and responder (Yes or No) as response variable.|Treatment difference|83.7|||<|0.0001|TWO_SIDED|95.0|78.7|88.7|||Regression, Logistic|||Superiority analysis of Dysport® to placebo was tested using a multivariate logistic regression model.||88.7|78.7|<0.0001
72576755|NCT00602641|144680618|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Presuming the control over the experimental arm (MPT-T/mPR-R), the inferiority of mPR-R was defined as a PFS treatment hazard ratio (HR) of less than or equal to 0.82 corresponding to median PFS on the mPR-R arm of 20.5 months (mos) vs. 25 mos on the MPT-T arm. With 304 patients and 221 PFS events, there was 86% power to detect non-inferiority of mPR-R at a 1-sided 0.05 significance level assuming a superiority alternative of HR=1.2 corresponding to median PFS on the mPR-R arm of 30 mos.|Hazard Ratio (HR)|0.84|||||TWO_SIDED|90.0|0.67|1.045|||||Analysis based on stratified cox regression by ISS stage (I-II vs. III) and age (\< 65y vs. ≥ 65y). The fact that the lower-bound was less than 0.82 and the upper bound was above 1.0 indicates that results were inconclusive for the primary objective.|Since mPR-R was expected to be considerably less toxic and to confer slightly longer PFS, a non-inferiority design with superiority alternative was used.||1.045|0.67|
72576756|NCT00602641|144680619|SUPERIORITY_OR_OTHER_LEGACY|||||||0.476|TWO_SIDED||||||Log Rank|Analysis was based on stratified cox regression by ISS stage (I-II vs. III) and age (\< 65y vs. ≥ 65y).||||||0.476
72525214|NCT00126425|144580826|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.44|||=|0.004|TWO_SIDED|95.0|0.23|0.84||At 0.025 level of significance.|Cox Proportional Hazards Model|||"Analysis based on Reader B readings. Data analysis to assess the relative hazard of an adverse cardiac event was performed using a Cox proportional hazards model. Hazard (risk) of an event for a participant with low H/M at time t was expressed as Hl (t)/ Hh (t) = Ψ, where Hl (t) and Hh (t) denote the hazard of an event at time t for participants with low H/M and high H/M respectively."||0.84|0.23|=0.004
72525215|NCT00126425|144580826|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.44|||=|0.004|TWO_SIDED|95.0|0.23|0.84||At 0.025 level of significance.|Cox Proportional Hazards Model|||"Analysis based on Reader C readings. Data analysis to assess the relative hazard of an adverse cardiac event was performed using a Cox proportional hazards model. Hazard (risk) of an event for a participant with low H/M at time t was expressed as Hl (t)/ Hh (t) = Ψ, where Hl (t) and Hh (t) denote the hazard of an event at time t for participants with low H/M and high H/M respectively."||0.84|0.23|=0.004
72525216|NCT04474366|144580831|SUPERIORITY|||||||0.72|||||||t-test, 2 sided|||||||0.72
72525217|NCT01365091|144580855|NON_INFERIORITY_OR_EQUIVALENCE|Metformin, Arm 1: The corresponding power and coefficient of variation between test and reference drugs are 98% and 17.24%, respectively|Geometric mean ratio|95.204|||||TWO_SIDED|90.0|87.618|103.446|||ANCOVA||Geometric mean ratio is calculated as B/A, where A=individual tablets (reference value) and B=FDC (test value)|||103.446|87.618|
72525218|NCT01365091|144580855|NON_INFERIORITY_OR_EQUIVALENCE|Saxagliptin, Arm 1: The corresponding power and coefficient of variation are 80% and 22.62%, respectively.|Geometric mean ratio|107.606|||||TWO_SIDED|90.0|96.552|119.924|||ANCOVA||Geometric mean ratio is calculated as B/A, where A=individual tablets (reference value) and B=FDC (test value)|||119.924|96.552|
72525219|NCT01365091|144580855|NON_INFERIORITY_OR_EQUIVALENCE|5-OH Saxagliptin, Arm 1: The corresponding power and the coefficient of variation are 99% and 16.26%, respectively.|Geometric mean ratio|104.373|||||TWO_SIDED|90.0|96.504|112.883|||||Geometric mean ratio is calculated as B/A, where A=individual tablets (reference value) and B= FDC (test value)|||112.883|96.504|
72525220|NCT01365091|144580855|NON_INFERIORITY_OR_EQUIVALENCE|Metformin, Arm 2: The corresponding power and the variation coefficient are 81% and 14.42%,respectively.|Geometric mean ratio|88.188|||||TWO_SIDED|90.0|82.368|94.419|||ANCOVA||Geometric mean ratio is calculated as B/A, where A=individual tablets (reference value) and B=FDC (test value)|||94.419|82.368|
72525221|NCT01365091|144580855|NON_INFERIORITY_OR_EQUIVALENCE|Saxagliptin, Arm 2: The corresponding power and the variation coefficient are 99% and 13.09%, respectively.|Geometric mean ratio|98.168|||||TWO_SIDED|90.0|92.263|104.451|||ANCOVA||Geometric mean ratio is calculated as B/A, where A=individual tablets (reference value) and B=FDC (test value)|||104.451|92.263|
72525222|NCT01365091|144580855|NON_INFERIORITY_OR_EQUIVALENCE|5-OH saxagliptin, Arm 2: The corresponding power and the variation coefficient are 99% and 8.02%, respectively.|Geometric mean ratio|95.023|||||TWO_SIDED|90.0|91.47|98.714|||ANCOVA||Geometric mean ratio is calculated as B/A, where A=individual tablets (reference value) and B=FDC (test value)|||98.714|91.470|
72525223|NCT01365091|144580855|NON_INFERIORITY_OR_EQUIVALENCE|Metformin, Arm 3: The corresponding power and the variation coefficient are 99% and 15.55%, respectively.|Geometric mean ratio|97.601|||||TWO_SIDED|90.0|15.55|99.0|||ANCOVA||Geometric mean ratio is calculated as B/A, where A=individual tablets (reference value) and B=FDC (test value)|||99|15.55|
72525224|NCT01365091|144580855|NON_INFERIORITY_OR_EQUIVALENCE|Saxagliptin, Arm 3: The corresponding power and the variation coefficient are 84% and 15.65%, respectively.|Geometric mean ratio|110.656|||||TWO_SIDED|90.0|102.416|119.559|||ANCOVA||Geometric mean ratio is calculated as B/A, where A=individual tablets (reference value) and B=FDC (test value)|||119.559|102.416|
72525225|NCT01365091|144580855|NON_INFERIORITY_OR_EQUIVALENCE|OH-Saxagliptin, Arm 3: The corresponding power and the variation coefficient are 99% and 12.61%, respectively.|Geometric mean ratio|106.264|||||TWO_SIDED|90.0|99.826|113.117|||ANCOVA||Geometric mean ratio is calculated as B/A, where A=individual tablets (reference value) and B=FDC (test value)|||113.117|99.826|
72525226|NCT01365091|144580855|NON_INFERIORITY_OR_EQUIVALENCE|Metformin, Arm 4: The corresponding power and the variation coefficient are 99% and 10.30%, respectively.|Geometric mean ratio|100.028|||||TWO_SIDED|90.0|95.164|105.139|||ANCOVA||Geometric mean ratio is calculated as B/A, where A=individual tablets (reference value) and B=FDC (test value)|||105.139|95.164|
72525227|NCT01365091|144580855|NON_INFERIORITY_OR_EQUIVALENCE|Saxagliptin, Arm 4: The corresponding power and the variation coefficient are 99% and 10.38%, respectively.|Geometric mean ratio|93.644|||||TWO_SIDED|95.0|89.055|98.47|||ANCOVA|Geometric mean ratio is calculated as B/A, where A=individual tablets (reference value) and B=FDC (test value)|Geometric mean ratio is calculated as B/A, where A=individual tablets (reference value) and B=FDC (test value)|||98.470|89.055|
72571126|NCT02358343|144670622|SUPERIORITY|||||||0.77||||||a priori threshold for significance is 0.05.|Likelihood Ratio Test|Likelihood ratio test obtained from logistic regression analysis adjusting for site||||||0.77
72576757|NCT00602641|144680620|SUPERIORITY_OR_OTHER_LEGACY|||||||0.204|TWO_SIDED||||||Fisher Exact|||||||0.204
72576758|NCT00602641|144680621|SUPERIORITY_OR_OTHER_LEGACY|||||||0.007|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.007
72525228|NCT01365091|144580856|NON_INFERIORITY_OR_EQUIVALENCE|Metformin, Arm 1: The corresponding power and coefficient of variation are 98% and 17.24%, respectively.|Geometric mean ratio|91.508|||||TWO_SIDED|90.0|82.596|101.38|||ANCOVA||Geometric mean ratio is calculated as B/A, where A=individual tablets (reference value) and B=FDC (test value)|||101.380|82.596|
72525229|NCT01365091|144580856|NON_INFERIORITY_OR_EQUIVALENCE|Saxagliptin, Arm 1: The corresponding power and the coefficient of variation are 99% and 07.66%, respectively.|Geometric mean ratio|97.437|||||TWO_SIDED|90.0|93.889|101.119|||ANCOVA||Geometric mean ratio is calculated as B/A, where A=individual tablets (reference value) and B=FDC (test value)|||101.119|93.889|
72525230|NCT01365091|144580856|NON_INFERIORITY_OR_EQUIVALENCE|5-OH Saxagliptin, Arm 1: The corresponding power and the coefficient of variation are 99% and 07.43%, respectively.|Geometric mean ratio|96.77|||||TWO_SIDED|90.0|93.35|100.316|||ANCOVA||Geometric mean ratio is calculated as B/A, where A=individual tablets (reference value) and B=FDC (test value)|||100.316|93.350|
72525231|NCT01365091|144580856|NON_INFERIORITY_OR_EQUIVALENCE|Metformin, Arm 2: The corresponding power and the variation coefficient are 96% and 14.37%, respectively.|Geometric mean ratio|91.585|||||TWO_SIDED|90.0|85.56|98.035|||ANCOVA||Geometric mean ratio is calculated as B/A, where A=individual tablets (reference value) and B=FDC (test value)|||98.035|85.56|
72525232|NCT01365091|144580856|NON_INFERIORITY_OR_EQUIVALENCE|Saxagliptin, Arm 2: The corresponding power and the variation coefficient are 96.028% and 101.095%, respectively.|Geometric mean ratio|98.529|||||TWO_SIDED|90.0|96.028|101.095|||ANCOVA||Geometric mean ratio is calculated as B/A, where A=individual tablets (reference value) and B=FDC (test value)|||101.095|96.028|
72525233|NCT01365091|144580856|NON_INFERIORITY_OR_EQUIVALENCE|5-OH Saxagliptin, Arm 2: The corresponding power and the variation coefficient are 99% and 6.55%, respectively|Geometric mean ratio|96.239|||||TWO_SIDED|90.0|93.286|99.286|||ANCOVA||Geometric mean ratio is calculated as B/A, where A=individual tablets (reference value) and B=FDC (test value)|||99.286|93.286|
72525234|NCT01365091|144580856|NON_INFERIORITY_OR_EQUIVALENCE|Metformin, Arm 3: The corresponding power and the variation coefficient are 99% and 12.19%, respectively.|Geometric mean ratio|102.994|||||TWO_SIDED|90.0|96.956|109.407|||ANCOVA||Geometric mean ratio is calculated as B/A, where A=individual tablets (reference value) and B=FDC (test value)|||109.407|96.956|
72525235|NCT01365091|144580856|NON_INFERIORITY_OR_EQUIVALENCE|Saxagliptin, Arm 3: The corresponding power and the variation coefficient are 99% and 7.07%, respectively.|Geometric mean ratio|97.135|||||TWO_SIDED|95.0|93.778|100.613|||ANCOVA||Geometric mean ratio is calculated as B/A, where A=individual tablets (reference value) and B=FDC (test value)|||100.613|93.778|
72525236|NCT01365091|144580856|NON_INFERIORITY_OR_EQUIVALENCE|5-OH Saxagliptin, Arm 3: The corresponding power and the variation coefficient are 99% and 7.18%, respectively.|Geometric mean ratio|100.01|||||TWO_SIDED|90.0|96.512|103.648|||ANCOVA||Geometric mean ratio is calculated as B/A, where A=individual tablets (reference value) and B=FDC (test value)|||103.648|96.512|
72525237|NCT01365091|144580856|NON_INFERIORITY_OR_EQUIVALENCE|Metformin, Arm 1:The corresponding power and the variation coefficient are 93% and 17.35%, respectively.|Geometric mean ratio|92.953|||||TWO_SIDED|90.0|85.502|101.053|||ANCOVA||Geometric mean ratio is calculated as B/A, where A=individual tablets (reference value) and B=FDC (test value)|||101.053|85.502|
72525238|NCT01365091|144580856|NON_INFERIORITY_OR_EQUIVALENCE|Saxagliptin, Arm 4: The corresponding power and the variation coefficient are 99% and 5.75%, respectively.|Geometric mean ratio|101.281|||||TWO_SIDED|95.0|98.494|104.147|||ANCOVA||Geometric mean ratio is calculated as B/A, where A=individual tablets (reference value) and B=FDC (test value)|||104.147|98.494|
72525239|NCT01365091|144580856|NON_INFERIORITY_OR_EQUIVALENCE|5-OH Saxagliptin, Arm 4: The corresponding power and the variation coefficient are 99% and 5.73%, respectively.|Geometric mean ratio|100.111|||||TWO_SIDED|90.0|97.367|102.932|||ANCOVA||Geometric mean ratio is calculated as B/A, where A=individual tablets (reference value) and B=FDC (test value)|||102.932|97.367|
72525240|NCT01365091|144580858|NON_INFERIORITY_OR_EQUIVALENCE|For AUC(0-inf) metformin, Arm 1, the corresponding power and coefficient of variation are 80% and 21.06%, respectively.|Geometric mean ratio|91.494|||||TWO_SIDED|90.0|82.697|101.226|||ANCOVA||Geometric mean ratio is calculated as B/A, where A=individual tablets (reference value) and B=FDC (test value).|||101.226|82.697|
72525241|NCT01365091|144580858|NON_INFERIORITY_OR_EQUIVALENCE|Saxagliptin, Arm 1: The corresponding power and the coefficient of variation are 99% and 07.60%, respectively.|Geometric mean ratio|97.477|||||TWO_SIDED|90.0|93.955|101.132|||ANCOVA||Geometric mean ratio is calculated as B/A, where A=individual tablets (reference value) and B=FDC (test value)|||101.132|93.955|
72525242|NCT01365091|144580858|NON_INFERIORITY_OR_EQUIVALENCE|5-OH Saxagliptin, Arm 1. The corresponding power and the coefficient of variation are 99% and 07.31%, respectively.|Geometric mean ratio|96.76|||||TWO_SIDED|90.0|93.393|100.247|||ANCOVA||Geometric mean ratio is calculated as B/A, where A=individual tablets (reference value) and B=FDC (test value).|||100.247|93.393|
72525243|NCT01365091|144580858|NON_INFERIORITY_OR_EQUIVALENCE|Metformin, Arm 2: The corresponding power and the variation coefficient are 96% and 14.25%, respectively.|Geometric mean ratio|91.548|||||TWO_SIDED|90.0|85.573|97.939|||ANCOVA||Geometric mean ratio is calculated as B/A, where A=individual tablets (reference value) and B=FDC (test value)|||97.939|85.573|
72525244|NCT01365091|144580858|NON_INFERIORITY_OR_EQUIVALENCE|Saxagliptin, Arm 2: The corresponding power and the variation coefficient are 99% and 5.38%,respectively.|Geometric mean ratio|98.535|||||TWO_SIDED|95.0|96.044|101.09|||ANCOVA||Geometric mean ratio is calculated as B/A, where A=individual tablets (reference value) and B=FDC (test value)|||101.090|96.044|
72525245|NCT01365091|144580858|NON_INFERIORITY_OR_EQUIVALENCE|5-OH Saxagliptin, Arm 2: The corresponding power and the variation coefficient are 99% and 6.52%, respectively.|Geometric mean ratio|96.258|||||TWO_SIDED|95.0|93.319|99.29|||ANCOVA||Geometric mean ratio is calculated as B/A, where A=individual tablets (reference value) and B=FDC (test value)|||99.290|93.319|
72525246|NCT01365091|144580858|NON_INFERIORITY_OR_EQUIVALENCE|Metformin, Arm 3: The corresponding power and the variation coefficient are 99% and 11.75%, respectively.|Geometric mean ratio|102.383|||||TWO_SIDED|95.0|96.589|108.525|||ANCOVA||Geometric mean ratio is calculated as B/A, where A=individual tablets (reference value) and B=FDC (test value)|||108.525|96.589|
72525247|NCT01365091|144580858|NON_INFERIORITY_OR_EQUIVALENCE|Saxagliptin, Arm 5: The corresponding power and the variation coefficient are 99% and 7.07%, respectively.|Geometric mean ratio|97.187|||||TWO_SIDED|90.0|93.832|100.662|||ANCOVA||Geometric mean ratio is calculated as B/A, where A=individual tablets (reference value) and B=FDC (test value)|||100.662|93.832|
72525248|NCT01365091|144580858|NON_INFERIORITY_OR_EQUIVALENCE|5-OH Sarexagliptin, Arm 3: The corresponding power and the variation coefficient are 99% and 7.08%, respectively.|Geometric mean ratio|100.015|||||TWO_SIDED|95.0|96.56|103.594|||ANCOVA||Geometric mean ratio is calculated as B/A, where A=individual tablets (reference value) and B=FDC (test value)|||103.594|96.560|
72525249|NCT01365091|144580858|NON_INFERIORITY_OR_EQUIVALENCE|Metformin, Arm 4: The corresponding power and the variation coefficient are 94% and 17.13%, respectively.|Geometric mean ratio|93.219|||||TWO_SIDED|90.0|85.835|101.238|||ANCOVA|||||101.238|85.835|
72525250|NCT01365091|144580858|NON_INFERIORITY_OR_EQUIVALENCE|Saxagliptin, Arm 4: The corresponding power and the variation coefficient are 99% and 5.72%, respectively.|Geometric mean ratio|101.346|||||TWO_SIDED|90.0|98.574|104.196|||ANCOVA||Geometric mean ratio is calculated as B/A, where A=individual tablets (reference value) and B=FDC (test value)|||104.196|98.574|
72525251|NCT01365091|144580858|NON_INFERIORITY_OR_EQUIVALENCE|5-OH Saxagliptin, Arm 4: The corresponding power and the variation coefficient are 99% and 5.71%, respectively.|Geometric mean ratio|100.056|||||TWO_SIDED|90.0|97.324|102.864|||ANCOVA||Geometric mean ratio is calculated as B/A, where A=individual tablets (reference value) and B=FDC (test value)|||102.864|97.324|
72525252|NCT02735044|144580891|NON_INFERIORITY|Non-inferiority of HOE901-U300 versus Lantus was demonstrated if the upper bound of the two-sided 95% confidence interval (CI) for the difference in the mean change in HbA1c from baseline to month 6 was \<0.3%.|LS Mean difference|0.004|STANDARD_ERROR_OF_MEAN|0.09|||TWO_SIDED|95.0|-0.172|0.179||||||Analysis was performed using ANCOVA models which included the treatment group, the randomization stratum of age group at screening visit (\<12 years and \>=12 years), and the continuous fixed covariates of the baseline HbA1c value.||0.179|-0.172|
72525253|NCT02735044|144580891|SUPERIORITY|Superiority of HOE901-U300 versus Lantus was demonstrated if the upper bound of the two-sided 95% CI for the difference between treatment groups was \<0 (zero).||||||0.965||||||Threshold for significance at 0.025 level.|ANCOVA|||A step-wise closed testing approach was used to control the type I error. Analysis was performed using ANCOVA models which included the treatment group, the randomization stratum of age group at screening visit (\<12 years and \>=12 years), and the continuous fixed covariates of the baseline HbA1c value.||||0.965
72525254|NCT00142818|144580907|SUPERIORITY|||||||0.4|||||||ANOVA|||||||0.4
72525255|NCT02903966|144580936|OTHER||Least Square Mean Difference|-0.18|||||TWO_SIDED|95.0|-1.23|0.87|||||Analysis performed using a Mixed Models Repeated Measures (MMRM) model, adjusting for the following covariates: treatment, visit, Baseline value, and the treatment by visit and baseline value by visit interactions|||0.87|-1.23|
72525256|NCT02903966|144580937|OTHER||Least Square Mean Difference|0.02|||||TWO_SIDED|95.0|-1.18|1.22|||||Analysis performed using a MMRM model, adjusting for the following covariates: treatment, visit, Baseline value, and the treatment by visit and baseline value by visit interactions|||1.22|-1.18|
72525257|NCT02903966|144580938|OTHER||Least Square Mean Difference|-0.05|||||TWO_SIDED|95.0|-4.11|4.02|||||Day 15. Analysis performed using a MMRM model, adjusting for the following covariates: treatment, visit, Baseline value, and the treatment by visit and Baseline value by visit interactions|||4.02|-4.11|
72406601|NCT02254278|144321761|SUPERIORITY||Hazard Ratio (HR)|1.43||||0.58|TWO_SIDED|95.0|0.4|5.08|||Log Rank|Two-sided significance level = 0.05|Reference level = IMRT 5 weeks|||5.08|0.4|0.58
72406602|NCT02254278|144321762|SUPERIORITY||Hazard Ratio (HR)|0.95||||0.93|TWO_SIDED|95.0|0.31|2.95||Two-side significance level = 0.05|Log Rank||Reference level = IMRT 5 weeks|||2.95|0.31|0.93
72406603|NCT02254278|144321763|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|Two-sided significance level = 0.05||End of RT||||<0.0001
72525258|NCT02903966|144580938|OTHER||Least Square Mean Difference|-3.17|||||TWO_SIDED|95.0|-5.99|-0.35|||||Day 29. Analysis performed using a MMRM model, adjusting for the following covariates: treatment, visit, Baseline value, and the treatment by visit and Baseline value by visit interactions|||-0.35|-5.99|
72525259|NCT02903966|144580938|OTHER||Least Square Mean Difference|-1.69|||||TWO_SIDED|95.0|-6.26|2.88|||||Day 43. Analysis performed using a MMRM model, adjusting for the following covariates: treatment, visit, Baseline value, and the treatment by visit and Baseline value by visit interactions|||2.88|-6.26|
72571127|NCT02358343|144670623|SUPERIORITY||Mean Difference (Final Values)|-1.84||||0.035|TWO_SIDED|95.0|-3.54|-0.13||a priori threshold for significance is 0.05.|Wald Test|The Wald test is for the week 12 comparative treatment effect from a longitudinal model of QIDS-C adjusting for clinical site.|The week 12 mean difference estimated from the longitudinal model is the difference between antidepressant drug therapy (drug) and the cognitive behavioral therapy (CBT) at 12 weeks, (drug - CBT).|All participants randomized to treatment (N=120) were included in the pre-specified longitudinal model of QIDS-C used to estimate comparative treatment effect at 12 weeks (primary outcome). The model adjustment for clinical site and included baseline, 6 week and 12 week QIDS-C scores. Week 0 (baseline) and week 6 measurements are not pre-specified primary or secondary outcomes. The Observational Cohort arm was not included in the analysis.||-0.13|-3.54|0.035
72571128|NCT02358343|144670624|SUPERIORITY|||||||0.96||||||a priori threshold for significance is 0.05.|Likelihood Ratio Test|Likelihood Ratio Test from logistic regression analysis adjusting for clinical site.||||||0.96
72525260|NCT02903966|144580939|OTHER||Least Square Mean Difference|0.29|||||TWO_SIDED|95.0|-4.01|4.59|||||Day 57. Analysis performed using a MMRM model, adjusting for the following covariates: treatment, visit, Baseline value, and the treatment by visit and Baseline value by visit interactions|||4.59|-4.01|
72406604|NCT02254278|144321763|SUPERIORITY|||||||0.17|||||||Fisher Exact|Two-sided significance level = 0.05||One month after end of RT||||0.17
72406605|NCT02254278|144321763|SUPERIORITY|||||||0.16|||||||Fisher Exact|Two-side significance level = 0.05||Six months after end of RT||||0.16
72406606|NCT02254278|144321763|SUPERIORITY|||||||0.26|||||||Fisher Exact|Two-side significance level = 0.05||One year after end of RT||||0.26
72406607|NCT02254278|144321763|SUPERIORITY|||||||0.82|||||||Fisher Exact|Two-side significance level = 0.05||Two years after the end of RT||||0.82
72406608|NCT02254278|144321765|SUPERIORITY|||||||0.3|||||||binomial test|One-sided significance level = 0.10||Progression-free survival: The null hypothesis of negative predictive value ≤ 90% was tested against the alternative of \> 90% with a 1-sided binomial test at the 0.10 level.||||0.3
72525261|NCT02903966|144580939|OTHER||Least Square Mean Difference|0.11|||||TWO_SIDED|95.0|-3.64|3.85|||||Day 71. Analysis performed using a MMRM model, adjusting for the following covariates: treatment, visit, Baseline value, and the treatment by visit and Baseline value by visit interactions|||3.85|-3.64|
72525262|NCT02903966|144580939|OTHER||Least Square Mean Difference|1.12|||||TWO_SIDED|95.0|-2.87|5.1|||||Day 85. Analysis performed using a MMRM model, adjusting for the following covariates: treatment, visit, Baseline value, and the treatment by visit and Baseline value by visit interactions|||5.10|-2.87|
72525263|NCT02903966|144580940|OTHER||Ratio|0.7|||||TWO_SIDED|95.0|0.27|1.8|||||Day 15. Analysis performed using a MMRM model, adjusting for the following covariates: treatment, visit, log-transformed Baseline value, and the treatment by visit and log-transformed baseline value by visit interactions.|||1.80|0.27|
72525264|NCT02903966|144580940|OTHER||Ratio|0.44|||||TWO_SIDED|95.0|0.2|1.0|||||Day 29. Analysis performed using a MMRM model, adjusting for the following covariates: treatment, visit, log-transformed Baseline value, and the treatment by visit and log-transformed baseline value by visit interactions.|||1.00|0.20|
72525265|NCT02903966|144580940|OTHER||Ratio|0.23|||||TWO_SIDED|95.0|0.09|0.62|||||Day 43. Analysis performed using a MMRM model, adjusting for the following covariates: treatment, visit, log-transformed Baseline value, and the treatment by visit and log-transformed baseline value by visit interactions.|||0.62|0.09|
72625245|NCT01098747|144780081|SUPERIORITY_OR_OTHER||LS mean difference|-0.67||||0.367|TWO_SIDED|95.0|-2.12|0.79||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPID 0-8: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.79|-2.12|0.367
72406609|NCT02254278|144321765|SUPERIORITY|||||||0.07|||||||binomial test|One-sided significance level = 0.10||Local-regional control: The null hypothesis of negative predictive value ≤ 90% was tested against the alternative of \> 90% with a 1-sided binomial test at the 0.10 level.||||0.07
72406610|NCT02254278|144321766|SUPERIORITY|||||||0.28|||||||Fisher Exact|Two-sided significance level = 0.05||||||0.28
72406611|NCT02254278|144321767|SUPERIORITY|||||||0.03|||||||t-test, 2 sided|Two-sided significance level = 0.05||||||0.03
72525266|NCT02903966|144580941|OTHER||Ratio|0.49|||||TWO_SIDED|95.0|0.25|0.97|||||Day 57. Analysis performed using a MMRM model, adjusting for the following covariates: treatment, visit, log-transformed Baseline value, and the treatment by visit and log-transformed baseline value by visit interactions.|||0.97|0.25|
72525267|NCT02903966|144580941|OTHER||Ratio|0.56|||||TWO_SIDED|95.0|0.2|1.57|||||Day 71. Analysis performed using a MMRM model, adjusting for the following covariates: treatment, visit, log-transformed Baseline value, and the treatment by visit and log-transformed baseline value by visit interactions.|||1.57|0.20|
72525268|NCT02903966|144580941|OTHER||Ratio|0.82|||||TWO_SIDED|95.0|0.31|2.18|||||Day 85. Analysis performed using a MMRM model, adjusting for the following covariates: treatment, visit, log-transformed Baseline value, and the treatment by visit and log-transformed baseline value by visit interactions.|||2.18|0.31|
72525269|NCT02903966|144580942|OTHER||Least Square Mean Difference|0.01|||||TWO_SIDED|95.0|-2.05|2.07|||||Analysis performed using a MMRM model, adjusting for the following covariates: treatment, visit, Baseline score, and the treatment by visit and Baseline score by visit interactions.|||2.07|-2.05|
72525270|NCT02903966|144580943|OTHER||Least Square Mean Difference|0.08|||||TWO_SIDED|95.0|-2.11|2.27|||||Analysis performed using a MMRM model, adjusting for the following covariates: treatment, visit, Baseline score, and the treatment by visit and Baseline score by visit interactions.|||2.27|-2.11|
72525271|NCT02903966|144580944|OTHER||Least Square Mean Difference|-0.76|||||TWO_SIDED|95.0|-5.29|3.77|||||Analysis performed using a MMRM model, adjusting for the following covariates: treatment, visit, Baseline score, and the treatment by visit and Baseline score by visit interactions.|||3.77|-5.29|
72525272|NCT02903966|144580945|OTHER||Least Square Mean Difference|-0.8|||||TWO_SIDED|95.0|-5.68|4.08|||||Analysis performed using a MMRM model, adjusting for the following covariates: treatment, visit, Baseline score, and the treatment by visit and Baseline score by visit interactions.|||4.08|-5.68|
72525273|NCT02903966|144580950|OTHER||Least Square Mean Difference|-0.36|||||TWO_SIDED|95.0|-1.58|0.86|||||Day 15. Analysis performed using a MMRM model, adjusting for the following covariates: treatment, visit, Baseline score, and the treatment by visit and Baseline score by visit interactions.|||0.86|-1.58|
72525274|NCT02903966|144580950|OTHER||Least Square Mean Difference|-0.1|||||TWO_SIDED|95.0|-1.29|1.08|||||Day 29. Analysis performed using a MMRM model, adjusting for the following covariates: treatment, visit, Baseline score, and the treatment by visit and Baseline score by visit interactions.|||1.08|-1.29|
72525275|NCT02903966|144580950|OTHER||Least Square Mean Difference|-0.34|||||TWO_SIDED|95.0|-1.72|1.04|||||Day 43. Analysis performed using a MMRM model, adjusting for the following covariates: treatment, visit, Baseline score, and the treatment by visit and Baseline score by visit interactions.|||1.04|-1.72|
72525276|NCT02903966|144580951|OTHER||Least Square Mean Difference|-0.06|||||TWO_SIDED|95.0|-1.87|1.75|||||Analysis performed using a MMRM model, adjusting for the following covariates: treatment, visit, Baseline score, and the treatment by visit and Baseline score by visit interactions.|||1.75|-1.87|
72525277|NCT03057106|144580955|SUPERIORITY||Hazard Ratio (HR)|0.88||||0.46|TWO_SIDED|90.0|0.67|1.16||2-sided, adjusted for stratification factors at rtandomization.|Log Rank|||||1.16|0.67|0.46
72406612|NCT02254278|144321771|SUPERIORITY|||||||0.08|||||||Fisher Exact|Two-sided significance level = 0.05||||||0.08
72525278|NCT03057106|144580956|SUPERIORITY||Hazard Ratio (HR)|0.67||||0.0035|TWO_SIDED|95.0|0.52|0.88||2-sided, adjusted for stratification factors at randomization.|Log Rank|Adjusted for stratification factors at randomization.||||0.88|0.52|0.0035
72525279|NCT03057106|144580957|SUPERIORITY||Odds Ratio (OR)|1.69||||0.033|TWO_SIDED|95.0|1.04|2.76||2-sided, adjusted for stratification factors at randomization.|Cochran-Mantel-Haenszel|||||2.76|1.04|0.033
72525280|NCT04423718|144580958|NON_INFERIORITY|One-sided test (alpha=0.025) for non-inferiority at a 4-letter margin|Difference in LS means|-0.97||||0.0009|TWO_SIDED|95.0|-2.87|0.92||Strictly hierarchical testing procedure: Since p-value below significance level 0.025, fixed sequence testing continued with next primary endpoint (HDq16-2q8) / within EMA/PMDA specific hierarchy with secondary endpoint (BCVA at W60, HDq12-2q8)|Mixed Models Analysis|Adjusted for baseline BCVA and randomization strata|Estimation mainly based on hypothetical strategy, i.e. observed data beyond intercurrent events (premature discontinuation of treatment, missing injection, prohibited medication) were censored. Missing/censored data was handled implicitly by MMRM|HDq12 - 2q8||0.92|-2.87|0.0009
72525281|NCT04423718|144580958|NON_INFERIORITY|One-sided test (alpha=0.025) for non-inferiority at a 4-letter margin|Difference in LS means|-1.14||||0.0011|TWO_SIDED|95.0|-2.97|0.69||Strictly hierarchical testing procedure: Since p-value below significance level 0.025, fixed sequence testing continued with secondary endpoint (no IRF no SRF at W16)/within EMA/PMDA specific hierarchy with secondary endpoint (BCVA at W60, HDq16-2q8)|Mixed Models Analysis|Adjusted for baseline BCVA and randomization strata|Estimation mainly based on hypothetical strategy, i.e. observed data beyond intercurrent events (premature discontinuation of treatment, missing injection, prohibited medication) were censored. Missing/censored data was handled implicitly by MMRM|HDq16 - 2q8||0.69|-2.97|0.0011
72525282|NCT04423718|144580959|NON_INFERIORITY|One-sided test (alpha=0.025) for non-inferiority at a 4-letter margin|Difference in LS means|-0.86||||0.0002|TWO_SIDED|95.0|-2.57|0.84||EMA/PMDA specific hierarchy: i.e. secondary endpoint was tested for EMA/PMDA after primary endpoint (HDq12-2q8). Since p-value below significance level 0.025, EMA/PMDA specific fixed sequence testing continued with next primary endpoint (HDq16-2q8)|Mixed Models Analysis|Adjusted for baseline BCVA and randomization strata|Estimation mainly based on hypothetical strategy, i.e. observed data beyond intercurrent events (premature discontinuation of treatment, missing injection, prohibited medication) were censored. Missing/censored data was handled implicitly by MMRM|HDq12 - 2q8||0.84|-2.57|0.0002
72571129|NCT02358343|144670625|SUPERIORITY||Mean Difference (Final Values)|-3.7|||||TWO_SIDED|95.0|-7.4|-0.02|||||The mean difference estimate is from longitudinal model adjusted for clinical site. It is the difference in scores between treatment groups (Drug - CBT) at 12 weeks. All participants are included in the longitudinal model (N=120).|||-0.02|-7.4|
72571130|NCT02358343|144670626|SUPERIORITY||Mean Difference (Final Values)|-1.2|||||TWO_SIDED|95.0|-3.1|0.8|||||The mean difference estimate is from longitudinal model adjusted for clinical site. It is the difference in scores between treatment groups (Drug - CBT) at 12 weeks. All participants are included in the longitudinal model (N=120).|||0.8|-3.1|
72571131|NCT02358343|144670627|SUPERIORITY||Mean Difference (Final Values)|-3.1|||||TWO_SIDED|95.0|-6.2|-0.1|||||The mean difference estimate is from longitudinal model adjusted for clinical site. It is the difference in scores between treatment groups (Drug - CBT) at 12 weeks. All participants are included in the longitudinal model (N=120).|||-0.1|-6.2|
72571132|NCT02358343|144670628|SUPERIORITY||Mean Difference (Final Values)|10.2|||||TWO_SIDED|95.0|1.3|19.0|||||The mean difference estimate is from longitudinal model adjusted for clinical site. It is the difference in scores between treatment groups (Drug - CBT) at 12 weeks. All participants are included in the longitudinal model (N=120).|||19.0|1.3|
72571133|NCT02358343|144670629|SUPERIORITY||Mean Difference (Final Values)|0.6|||||TWO_SIDED|95.0|-0.2|1.4|||||The mean difference estimate is from longitudinal model adjusted for clinical site. It is the difference in scores between treatment groups (Drug - CBT) at 12 weeks. All participants are included in the longitudinal model (N=120).|||1.4|-0.2|
72571134|NCT02358343|144670630|SUPERIORITY||Mean Difference (Final Values)|2.6|||||TWO_SIDED|95.0|0.1|5.1|||||The mean difference estimate is from longitudinal model adjusted for clinical site. It is the difference in scores between treatment groups (Drug - CBT) at 12 weeks. All participants are included in the longitudinal model (N=120).|||5.1|0.1|
72625246|NCT01098747|144780082|SUPERIORITY_OR_OTHER||LS mean difference|3.95|||<|0.001|TWO_SIDED|95.0|3.32|4.59||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||TOTPAR 0-2: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||4.59|3.32|< 0.001
72625247|NCT01098747|144780082|SUPERIORITY_OR_OTHER||LS mean difference|0.62||||0.009|TWO_SIDED|95.0|0.16|1.07||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||TOTPAR 0-2: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.07|0.16|0.009
72625248|NCT01098747|144780082|SUPERIORITY_OR_OTHER||LS mean difference|6.15|||<|0.001|TWO_SIDED|95.0|5.18|7.12||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||TOTPAR 0-3: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||7.12|5.18|<0.001
72406613|NCT02254278|144321772|SUPERIORITY|||||||0.02||||||Two-sided significance level = 0.05|Fisher Exact|||||||0.02
72406614|NCT02782949|144321809|SUPERIORITY|||||||0.399|||||||Wilcoxon Rank-Sum test|||||||0.3990
72571135|NCT02358343|144670631|SUPERIORITY||Mean Difference (Final Values)|-0.01|||||TWO_SIDED|95.0|-0.5|0.5|||||The mean difference estimate is from longitudinal model adjusted for clinical site. It is the difference in scores between treatment groups (Drug - CBT) at 12 weeks. All participants are included in the longitudinal model (N=120).|||0.5|-0.5|
72571136|NCT02358343|144670633|SUPERIORITY||Mean Difference (Final Values)|0.1|||||TWO_SIDED|95.0|-0.5|0.7|||||The mean difference estimate is from longitudinal model adjusted for clinical site. It is the difference in scores between treatment groups (Drug - CBT) at 12 weeks. All participants are included in the longitudinal model (N=120).|||0.7|-0.5|
72571137|NCT02358343|144670634|SUPERIORITY||Risk Ratio (RR)|0.78|||||TWO_SIDED|95.0|0.55|1.1|||||The mean difference estimate is from a negative binomial model adjusted for clinical site. It is the rate of sessions skipped/shortened in the Drug group (numerator) compared to CBT (denominator).|||1.10|0.55|
72571138|NCT02358343|144670635|SUPERIORITY||Mean Difference (Final Values)|-0.1|||||TWO_SIDED|95.0|-0.54|0.34|||||The mean difference estimate is from longitudinal model adjusted for clinical site. It is the difference in scores between treatment groups (Drug - CBT) at 12 weeks. All participants are included in the longitudinal model (N=120).|||0.34|-0.54|
72571139|NCT02358343|144670636|SUPERIORITY||Mean Difference (Final Values)|0.25|||||TWO_SIDED|95.0|-0.25|0.75|||||The mean difference estimate is from longitudinal model adjusted for clinical site. It is the difference in scores between treatment groups (Drug - CBT) at 12 weeks. All participants are included in the longitudinal model (N=120).|||0.75|-0.25|
72406615|NCT02782949|144321812|SUPERIORITY|||||||0.74|||||||Fisher Exact|||||||0.74
72406616|NCT05478174|144321831|NON_INFERIORITY|Non inferiority margin is -8%|Risk Difference (RD)|-0.0078|||<|0.001|TWO_SIDED|95.0|-0.0411|0.0255||P-Value for non inferiority test|Farrington-Manning method|||||0.0255|-0.0411|<0.001
72571140|NCT01462318|144670710|SUPERIORITY_OR_OTHER||ratio|1.015|||||TWO_SIDED|90.0|0.894|1.153|||||test/reference = midazolam+DAC HYP/midazolam|Pairwise comparison: midazolam. Based on linear mixed model with fixed effect for treatment and random effect for participants.||1.153|0.894|
72571141|NCT01462318|144670710|SUPERIORITY_OR_OTHER||ratio|1.005|||||TWO_SIDED|90.0|0.951|1.063|||||test/reference = S-warfarin+DAC HYP/S-warfarin|Pairwise comparison: S-warfarin. Based on linear mixed model with fixed effect for treatment and random effect for participants.||1.063|0.951|
72571142|NCT01462318|144670710|SUPERIORITY_OR_OTHER||ratio|0.996|||||TWO_SIDED|90.0|0.88|1.127|||||test/reference = omeprazole+DAC HYP/omeprazole|Pairwise comparison: omeprazole. Based on linear mixed model with fixed effect for treatment and random effect for participants.||1.127|0.880|
72571143|NCT01462318|144670710|SUPERIORITY_OR_OTHER||ratio|1.032|||||TWO_SIDED|90.0|0.93|1.145|||||test/reference = caffeine+DAC HYP/caffeine|Pairwise comparison: caffeine. Based on linear mixed model with fixed effect for treatment and random effect for participants. Excludes participants with high predose concentration (\>5% of maximum observed concentration \[Cmax\]).||1.145|0.930|
72406617|NCT05478174|144321832|SUPERIORITY||Risk Difference (RD)|-0.0716||||0.171|TWO_SIDED|95.0|-0.1742|0.031|||Cochran-Mantel-Haenszel|||||0.0310|-0.1742|0.171
72406618|NCT05478174|144321833|SUPERIORITY||Mean Difference (Final Values)|-1.76|STANDARD_ERROR_OF_MEAN|0.231|<|0.001|TWO_SIDED|95.0|-2.22|-1.31|||ANOVA|||||-1.31|-2.22|<0.001
72525283|NCT04423718|144580959|NON_INFERIORITY|One-sided test (alpha=0.025) for non-inferiority at a 4-letter margin|Difference in LS means|-0.92|||<|0.0001|TWO_SIDED|95.0|-2.51|0.66||EMA/PMDA specific hierarchy: i.e. secondary endpoint was tested after primary endpoint (HDq16-2q8). Since p-value below significance level 0.025, EMA/PMDA specific fixed sequence testing continued with secondary endpoint test (no IRF no SRF at W16)|Mixed Models Analysis|Adjusted for baseline BCVA and randomization strata|Estimation mainly based on hypothetical strategy, i.e. observed data beyond intercurrent events (premature discontinuation of treatment, missing injection, prohibited medication) were censored. Missing/censored data was handled implicitly by MMRM|HDq16 - 2q8||0.66|-2.51|<0.0001
72525284|NCT04423718|144580960|SUPERIORITY|One sided test (alpha = 0.025) for superiority|Difference|11.733||||0.0002|TWO_SIDED|95.0|5.263|18.204||Strictly hierarchical testing procedure to adjust for multiplicity.|Cochran-Mantel-Haenszel|CMH test stratified by baseline BCVA and randomization strata|Estimation mainly based on hypothetical strategy, i.e. observed data beyond intercurrent events (premature discontinuation of treatment, missing injection, prohibited medication) were censored. Missing/censored data was imputed by LOCF approach|All HD - 2q8||18.204|5.263|0.0002
72525285|NCT04423718|144580961|EQUIVALENCE|Two sided test (alpha = 0.05)|Difference|-1.748||||0.5704|TWO_SIDED|95.0|-7.784|4.287||Nominal p-value, not adjusted for multiplicity|Cochran-Mantel-Haenszel|CMH test stratified by baseline BCVA and randomization strata|Estimation mainly based on hypothetical strategy, i.e. observed data beyond intercurrent events (premature discontinuation of treatment, missing injection, prohibited medication) were censored. Missing/censored data was imputed by LOCF approach|HDq12 - 2q8||4.287|-7.784|0.5704
72525286|NCT04423718|144580961|EQUIVALENCE|Two sided test (alpha = 0.05)|Difference|-0.939||||0.7611|TWO_SIDED|95.0|-6.997|5.119||Nominal p-value, not adjusted for multiplicity|Cochran-Mantel-Haenszel|CMH test stratified by baseline BCVA and randomization strata|Estimation mainly based on hypothetical strategy, i.e. observed data beyond intercurrent events (premature discontinuation of treatment, missing injection, prohibited medication) were censored. Missing/censored data was imputed by LOCF approach|HDq16 - 2q8||5.119|-6.997|0.7611
72525287|NCT04423718|144580962|EQUIVALENCE|Two sided test (alpha = 0.05)|Difference|-0.182||||0.9554|TWO_SIDED|95.0|-6.565|6.2||Nominal p-value, not adjusted for multiplicity|Cochran-Mantel-Haenszel|CMH test stratified by baseline BCVA and randomization strata|Estimation mainly based on hypothetical strategy, i.e. observed data beyond intercurrent events (premature discontinuation of treatment, missing injection, prohibited medication) were censored. Missing/censored data was imputed by LOCF approach|HDq12 - 2q8||6.200|-6.565|0.9554
72525288|NCT04423718|144580962|EQUIVALENCE|Two sided test (alpha = 0.05)|Difference|-2.221||||0.4834|TWO_SIDED|95.0|-8.435|3.994||Nominal p-value, not adjusted for multiplicity|Cochran-Mantel-Haenszel|CMH test stratified by baseline BCVA and randomization strata|Estimation mainly based on hypothetical strategy, i.e. observed data beyond intercurrent events (premature discontinuation of treatment, missing injection, prohibited medication) were censored. Missing/censored data was imputed by LOCF approach|HDq16 - 2q8||3.994|-8.435|0.4834
72525289|NCT04423718|144580963|EQUIVALENCE|Two sided test (alpha = 0.05)|Difference in LS means|-1.22||||0.0009|TWO_SIDED|95.0|-1.94|-0.51||Nominal p-value, not adjusted for multiplicity|Mixed Models Analysis|Adjusted for baseline CNV size and randomization strata|Estimation mainly based on hypothetical strategy, i.e. observed data beyond intercurrent events (premature discontinuation of treatment, missing injection, prohibited medication) were censored. Missing/censored data was handled implicitly by MMRM|HDq12 - 2q8||-0.51|-1.94|0.0009
72525290|NCT04423718|144580963|EQUIVALENCE|Two sided test (alpha = 0.05)|Difference in LS means|-0.48||||0.2076|TWO_SIDED|95.0|-1.22|0.27||Nominal p-value, not adjusted for multiplicity|Mixed Models Analysis|Adjusted for baseline CNV size and randomization strata|Estimation mainly based on hypothetical strategy, i.e. observed data beyond intercurrent events (premature discontinuation of treatment, missing injection, prohibited medication) were censored. Missing/censored data was handled implicitly by MMRM|HDq16 - 2q8||0.27|-1.22|0.2076
72525291|NCT04423718|144580964|EQUIVALENCE|Two sided test (alpha = 0.05)|Difference in LS means|-0.55||||0.0287|TWO_SIDED|95.0|-1.04|-0.06||Nominal p-value, not adjusted for multiplicity|Mixed Models Analysis|Adjusted for baseline total lesion area and randomization strata|Estimation mainly based on hypothetical strategy, i.e. observed data beyond intercurrent events (premature discontinuation of treatment, missing injection, prohibited medication) were censored. Missing/censored data was handled implicitly by MMRM|HDq12 - 2q8||-0.06|-1.04|0.0287
72525292|NCT04423718|144580964|EQUIVALENCE|Two sided test (alpha = 0.05)|Difference in LS means|-0.44||||0.087|TWO_SIDED|95.0|-0.94|0.06||Nominal p-value, not adjusted for multiplicity|Mixed Models Analysis|Adjusted for baseline total lesion area and randomization strata|Estimation mainly based on hypothetical strategy, i.e. observed data beyond intercurrent events (premature discontinuation of treatment, missing injection, prohibited medication) were censored. Missing/censored data was handled implicitly by MMRM|HDq16 - 2q8||0.06|-0.94|0.0870
72525293|NCT04423718|144580965|EQUIVALENCE|Two sided test (alpha = 0.05)|Difference|11.725||||0.0015|TWO_SIDED|95.0|4.527|18.923||Nominal p-value, not adjusted for multiplicity|Cochran-Mantel-Haenszel|CMH test stratified by baseline BCVA and randomization strata|Estimation mainly based on hypothetical strategy, i.e. observed data beyond intercurrent events (premature discontinuation of treatment, missing injection, prohibited medication) were censored. Missing/censored data was imputed by LOCF approach|HDq12 - 2q8||18.923|4.527|0.0015
72525294|NCT04423718|144580965|EQUIVALENCE|Two sided test (alpha = 0.05)|Difference|7.451||||0.0458|TWO_SIDED|95.0|0.142|14.76||Nominal p-value, not adjusted for multiplicity|Cochran-Mantel-Haenszel|CMH test stratified by baseline BCVA and randomization strata|Estimation mainly based on hypothetical strategy, i.e. observed data beyond intercurrent events (premature discontinuation of treatment, missing injection, prohibited medication) were censored. Missing/censored data was imputed by LOCF approach|HDq16 - 2q8||14.760|0.142|0.0458
72525295|NCT04423718|144580966|EQUIVALENCE|Two sided test (alpha = 0.05)|Difference in LS means|-11.12||||0.0283|TWO_SIDED|95.0|-21.06|-1.18||Nominal p-value, not adjusted for multiplicity|Mixed Models Analysis|Adjusted for baseline CST and randomization strata|Estimation mainly based on hypothetical strategy, i.e. observed data beyond intercurrent events (premature discontinuation of treatment, missing injection, prohibited medication) were censored. Missing/censored data was handled implicitly by MMRM|HDq12 - 2q8||-1.18|-21.06|0.0283
72571144|NCT01462318|144670711|SUPERIORITY_OR_OTHER||ratio|1.012|||||TWO_SIDED|90.0|0.764|1.342|||||test/reference = dextromethorphan+DAC HYP/dextromethorphan|Pairwise comparison: dextromethorphan. Based on linear mixed model with fixed effect for treatment and random effect for participants.||1.342|0.764|
72406619|NCT02489318|144321865|SUPERIORITY||Hazard Ratio (HR)|0.484|||<|0.0001|TWO_SIDED|95.0|0.391|0.6|||Log Rank|||||0.600|0.391|<0.0001
72625249|NCT01098747|144780082|SUPERIORITY_OR_OTHER||LS mean difference|0.49||||0.166|TWO_SIDED|95.0|-0.21|1.2||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||TOTPAR 0-3: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.20|-0.21|0.166
72406620|NCT02489318|144321866|SUPERIORITY||Hazard Ratio (HR)|0.651|||<|0.0001|TWO_SIDED|95.0|0.534|0.793|||Log Rank|||||0.793|0.534|<0.0001
72406621|NCT02489318|144321867|SUPERIORITY||Hazard Ratio (HR)|0.469|||<|0.0001|TWO_SIDED|95.0|0.35|0.63|||Log Rank|||||0.630|0.350|<.0001
72525296|NCT04423718|144580966|EQUIVALENCE|Two sided test (alpha = 0.05)|Difference in LS means|-10.51||||0.0321|TWO_SIDED|95.0|-20.12|-0.9||Nominal p-value, not adjusted for multiplicity|Mixed Models Analysis|Adjusted for baseline CST and randomization strata|Estimation mainly based on hypothetical strategy, i.e. observed data beyond intercurrent events (premature discontinuation of treatment, missing injection, prohibited medication) were censored. Missing/censored data was handled implicitly by MMRM|HDq16 - 2q8||-0.90|-20.12|0.0321
72525297|NCT04423718|144580967|EQUIVALENCE|Two sided test (alpha = 0.05)|Difference in LS means|-0.72||||0.3817|TWO_SIDED|95.0|-2.35|0.9||Nominal p-value, not adjusted for multiplicity|Mixed Models Analysis|Adjusted for baseline NEI-VFQ-25 total score and randomization strata|Estimation mainly based on hypothetical strategy, i.e. observed data beyond intercurrent events (premature discontinuation of treatment, missing injection, prohibited medication) were censored. Missing/censored data was handled implicitly by MMRM|HDq12 - 2q8||0.90|-2.35|0.3817
72525298|NCT04423718|144580967|EQUIVALENCE|Two sided test (alpha = 0.05)|Difference in LS means|-0.87||||0.307|TWO_SIDED|95.0|-2.55|0.8||Nominal p-value, not adjusted for multiplicity|Mixed Models Analysis|Adjusted for baseline NEI-VFQ-25 total score and randomization strata|Estimation mainly based on hypothetical strategy, i.e. observed data beyond intercurrent events (premature discontinuation of treatment, missing injection, prohibited medication) were censored. Missing/censored data was handled implicitly by MMRM|HDq16 - 2q8||0.80|-2.55|0.3070
72525299|NCT00425945|144580971|SUPERIORITY_OR_OTHER||Mean Difference (Net)|7.3|||||TWO_SIDED|95.0|-0.1|14.9||||||||14.9|-0.1|
72525300|NCT00425945|144580972|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.4|||||TWO_SIDED|95.0|-2.1|10.8||||||||10.8|-2.1|
72525301|NCT00425945|144580973|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.4|||||TWO_SIDED|95.0|-1.7|2.5||||||||2.5|-1.7|
72525302|NCT00425945|144580974|SUPERIORITY_OR_OTHER||Mean Difference (Net)|18.2|||||TWO_SIDED|95.0|-2.3|38.7||||||||38.7|-2.3|
72525303|NCT00425945|144580975|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.1|||||TWO_SIDED|95.0|-0.1|0.3||||||||0.3|-0.1|
72525304|NCT00425945|144580976|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0|||||TWO_SIDED|95.0|0.0|0.1||||||||0.1|-0.0|
72525305|NCT00425945|144580977|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.2|||||TWO_SIDED|95.0|-6.8|0.5||||||||0.5|-6.8|
72525306|NCT00425945|144580978|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.5|||||TWO_SIDED|95.0|-1.5|0.5||||||||0.5|-1.5|
72525307|NCT00425945|144580979|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.2|||||TWO_SIDED|95.0|0.0|0.4||||||||0.4|0.0|
72525308|NCT00425945|144580980|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.2|||||TWO_SIDED|95.0|0.1|2.4||||||||2.4|0.1|
72525309|NCT00425945|144580981|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.0|||||TWO_SIDED|95.0|-4.4|2.3||||||||2.3|-4.4|
72406622|NCT02489318|144321868|SUPERIORITY||Hazard Ratio (HR)|0.868||||0.1966|TWO_SIDED|95.0|0.7|1.076|||Log Rank|||||1.076|0.700|0.1966
72406623|NCT02489318|144321869|SUPERIORITY||Hazard Ratio (HR)|0.794||||0.1563|TWO_SIDED|95.0|0.576|1.094|||Log Rank|||||1.094|0.576|0.1563
72525310|NCT00425945|144580982|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.8|||||TWO_SIDED|95.0|-0.9|2.5||||||||2.5|-0.9|
72525311|NCT00425945|144580983|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0|||||TWO_SIDED|95.0|-0.1|0.1||||||||0.1|-0.1|
72525312|NCT00425945|144580984|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.8|||||TWO_SIDED|95.0|-1.6|9.3||||||||9.3|-1.6|
72525313|NCT00425945|144580985|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.3|||||TWO_SIDED|95.0|-3.4|0.8||||||||0.8|-3.4|
72525314|NCT03991936|144580987|SUPERIORITY||Mean Difference (Net)|-2.635|||<|0.001|TWO_SIDED|||||The threshold for statistical analysis was p = 0.05|t-test, 2 sided|||The null hypothesis was that the change from baseline to 24 weeks in the Nail Psoriasis Severity Index (NAPSI) for the triamcinolone acetonide groups: 2.5 mg/mL, 5.0 mg/mL, 7.5 mg/mL, and 10 mg/mL would be no different than the change from baseline to 24 weeks for the placebo group.||||<0.001
72525315|NCT03258593|144581033|OTHER|Location Tests (Wilcoxon Rank sum test)|Median Difference (Net)|67.5||||0.202|TWO_SIDED|95.0|25.0|75.0||Unadjusted p-value|Wilcoxon Rank sum test|||||75|25|0.202
72525316|NCT03258593|144581033|OTHER|Location Tests (Wilcoxon Rank sum test)|Median Difference (Net)|114.0||||0.667|TWO_SIDED|95.0|67.9|160.3||Unadjusted p-value|Wilcoxon Rank sum test|||||160.3|67.9|0.667
72525317|NCT03258593|144581033|OTHER|Location Tests (Wilcoxon Rank sum test)|Median Difference (Net)|44.1||||0.463|TWO_SIDED|95.0|25.0|75.0|||Wilcoxon Rank sum test|||||75|25|0.463
72525318|NCT03258593|144581035|OTHER|Location test (Rank sum based i.e., Wilcoxon test)|Median Difference (Net)|-17.75||||0.863|TWO_SIDED|95.0|-211.6|170.3|||Wilcoxon Rank sum test||Median change; Signed Rank (S/R) of post-treatment PDL-1 levels minus baseline.|||170.3|-211.6|0.863
72406624|NCT02489318|144321870|SUPERIORITY||Hazard Ratio (HR)|0.857||||0.3608|TWO_SIDED|95.0|0.615|1.194|||Log Rank|||||1.194|0.615|0.3608
72406625|NCT01276314|144321891|OTHER|||||||0.01||||||The p-value was analyzed for SJS/TEN participants with \>10% body surface area detachment.|Kaplan-Meier analysis|||For evaluating the time taken to heal skin erosion, the Kaplan-Meier product-limit estimates method was performed. Differences were considered statistically significant at P values of less than 0.05.||||0.01
72525319|NCT03258593|144581035|OTHER|Location test (Rank sum based i.e., Wilcoxon test)|Median Difference (Net)|114.1||||0.666|TWO_SIDED|95.0|67.9|160.3|||Wilcoxon Rank sum test||Median change; Signed Rank (S/R) of post-treatment PDL-1 levels minus baseline.|||160.3|67.9|0.666
72625250|NCT01098747|144780082|SUPERIORITY_OR_OTHER||LS mean difference|11.67|||<|0.001|TWO_SIDED|95.0|9.54|13.81||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||TOTPAR 0-6: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||13.81|9.54|<0.001
72406626|NCT01276314|144321891|OTHER|||||||0.06||||||This p-value was analyzed for DRESS participants.|Kaplan-Meier analysis|||For evaluating the time taken to heal skin erosion, the Kaplan-Meier product-limit estimates method was performed. Differences were considered statistically significant at P values of less than 0.05.||||0.06
72406627|NCT00749775|144321894|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|ONE_SIDED||||||t-test, 1 sided|A one-sided paired t-test was performed to test the hypothesis.||The null hypothesis is that the mean systolic blood pressure at 4 weeks does not differ from that at baseline.||||<0.001
72406628|NCT00749775|144321894|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|ONE_SIDED||||||t-test, 1 sided|A one-sided paired t-test was performed to test the hypothesis.||The null hypothesis is that the mean systolic blood pressure at 8 weeks does not differ from that at baseline.||||<0.001
72406629|NCT00749775|144321894|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|ONE_SIDED||||||t-test, 1 sided|A one-sided paired t-test was performed to test the hypothesis.||The null hypothesis is that the mean systolic blood pressure at 12 weeks does not differ from that at baseline.||||<0.001
72406630|NCT00749775|144321894|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|ONE_SIDED||||||t-test, 1 sided|A one-sided paired t-test was performed to test the hypothesis.||The null hypothesis is that the mean systolic blood pressure at last evaluation date does not differ from that at baseline.||||<0.001
72525320|NCT03258593|144581035|OTHER|Location test (Rank sum based i.e., Wilcoxon test)|Median Difference (Net)|21.3||||0.949|TWO_SIDED|95.0|-203.9|269.9|||Wilcoxon Rank sum test||Median change; Signed Rank (S/R) of post-treatment PDL-1 levels minus baseline.|||269.9|-203.9|0.949
72525321|NCT03258593|144581037|OTHER|Other: median difference|Median Difference (Net)|4.34|||<|0.001|TWO_SIDED|95.0|1.7|38.0||Hochberg adjustment may be used.|Paired samples Wilcoxon rank sum test|||Interferon Gamma (IFN-γ) at 3 weeks compared to their respective baseline values.||38.0|1.7|<0.001
72525322|NCT03258593|144581037|OTHER|Other: median difference|Median Difference (Net)|3.29|||<|0.001|TWO_SIDED|95.0|1.5|11.25||Hochberg adjustment may be used.|Paired samples Wilcoxon rank sum test|||Interferon Gamma (IFN-γ) at 5 weeks compared to their respective baseline values.||11.25|1.5|<0.001
72525323|NCT03258593|144581037|OTHER|Other: median difference|Median Difference (Net)|0.4|||<|0.05|TWO_SIDED|95.0|0.1|0.7||Hochberg adjustment may be used.|Paired samples Wilcoxon rank sum test|||Tumor Necrosis Factor Alpha (TNF-α) at 3 weeks compared to their respective baseline values.||0.7|0.1|<0.05
72525324|NCT03258593|144581037|OTHER|Other: median difference|Median Difference (Net)|0.24||||0.052|TWO_SIDED|95.0|-0.01|0.96||Hochberg adjustment may be used.|Paired samples Wilcoxon rank sum test|||Tumor Necrosis Factor Alpha (TNF-α ) at 5 weeks compared to their respective baseline values.||0.96|-0.01|0.052
72525325|NCT03258593|144581037|OTHER|Other: median difference|Median Difference (Net)|0.39||||0.055|TWO_SIDED|95.0|-0.03|4.61||Hochberg adjustment may be used.|Paired samples Wilcoxon rank sum test|||Interleukin 6 (IL-6) at 3 weeks as compared to their respective baseline values.||4.61|-0.03|0.055
72525326|NCT03258593|144581037|OTHER|Other: median difference|Median Difference (Net)|0.54||||0.06|TWO_SIDED|95.0|-0.06|1.96|||Paired samples Wilcoxon rank sum test|Hochberg adjustment may be used.||Interleukin 6 (IL-6) at 5 weeks as compared to their respective baseline values.||1.96|-0.06|0.06
72571145|NCT01462318|144670719|SUPERIORITY_OR_OTHER||ratio|1.079|||||TWO_SIDED|90.0|0.912|1.276|||||test/reference = midazolam+DAC HYP/midazolam|Pairwise comparison: midazolam. Based on linear mixed model with fixed effect for treatment and random effect for participants.||1.276|0.912|
72571146|NCT01462318|144670719|SUPERIORITY_OR_OTHER||ratio|1.012|||||TWO_SIDED|90.0|0.952|1.075|||||test/reference = S-warfarin+DAC HYP/S-warfarin|Pairwise comparison: S-warfarin. Based on linear mixed model with fixed effect for treatment and random effect for participants.||1.075|0.952|
72525327|NCT03258593|144581037|OTHER|Other: median difference|Median Difference (Net)|0.73||||0.42|TWO_SIDED|95.0|-1.63|1.62||Hochberg adjustment may be used.|Paired samples Wilcoxon rank sum test|||Interleukin 8 (IL-8) at 3 weeks as compared to their respective baseline values.||1.62|-1.63|0.420
72406631|NCT00749775|144321895|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|ONE_SIDED||||||t-test, 1 sided|A one-sided paired t-test was performed to test the hypothesis.||The null hypothesis is that the mean diastolic blood pressure at 4 weeks does not differ from that at baseline.||||<0.001
72406632|NCT00749775|144321895|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|ONE_SIDED||||||t-test, 1 sided|A one-sided paired t-test was performed to test the hypothesis.||The null hypothesis is that the mean diastolic blood pressure at 8 weeks does not differ from that at baseline.||||<0.001
72406633|NCT00749775|144321895|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|ONE_SIDED||||||t-test, 1 sided|A one-sided paired t-test was performed to test the hypothesis.||The null hypothesis is that the mean diastolic blood pressure at 12 weeks does not differ from that at baseline.||||<0.001
72406634|NCT00749775|144321895|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|ONE_SIDED||||||t-test, 1 sided|A one-sided paired t-test was performed to test the hypothesis.||The null hypothesis is that the mean diastolic blood pressure at last evaluation date does not differ from that at baseline.||||<0.001
72525328|NCT03258593|144581037|OTHER|Other: median difference|Median Difference (Net)|-0.39||||0.733|TWO_SIDED|95.0|-1.315|1.31||Hochberg adjustment may be used.|Paired samples Wilcoxon rank sum test|||Interleukin 8 (IL-8) at 5 weeks as compared to their respective baseline values.||1.31|-1.315|0.733
72525329|NCT03258593|144581037|OTHER|Other: median difference|Median Difference (Net)|0.12||||0.01|TWO_SIDED|95.0|0.04|0.21||Hochberg adjustment may be used.|Paired samples Wilcoxon rank sum test|||Interleukin 10 (IL-10) at 3 weeks as compared to their respective baseline values.||0.21|0.04|0.010
72525330|NCT03258593|144581037|OTHER|Other: median difference|Median Difference (Net)|0.1||||0.014|TWO_SIDED|95.0|0.04|0.4||Hochberg adjustment may be used.|Paired samples Wilcoxon rank sum test|||Interleukin 10 (IL-10) at 5 weeks as compared to their respective baseline values.||0.40|0.04|0.014
72525331|NCT03258593|144581039|OTHER|One curve estimated in this cohort. Not compared to any other curves.|Kaplan-Meier product-limit|13.2|||||TWO_SIDED|97.5|2.5|97.5||Unadjusted p-value|Kaplan-Meier product-limit estimates|||Disease free survival time was evaluated with the product-limit estimator by Kaplan-Meier test.||97.5|2.5|
72525332|NCT01996865|144581114|OTHER||Hazard Ratio (HR)|0.8||||0.3296|TWO_SIDED|95.0|0.6|1.2|||Regression, Cox|||||1.2|0.6|0.3296
72406635|NCT01948375|144321899|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Chi-squared|||||||>0.05
72406636|NCT01948375|144321901|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.35||||0.007||95.0|1.26|4.4||For the comparison of direct effect of placebo needle and real needle, p=0.007|Generalized Estimating Equation|||||4.40|1.26|0.007
72571147|NCT01462318|144670719|SUPERIORITY_OR_OTHER||ratio|1.058|||||TWO_SIDED|90.0|0.804|1.392|||||test/reference = omeprazole+DAC HYP/omeprazole|Pairwise comparison: omeprazole. Based on linear mixed model with fixed effect for treatment and random effect for participants.||1.392|0.804|
72571148|NCT01462318|144670719|SUPERIORITY_OR_OTHER||ratio|1.116|||||TWO_SIDED|90.0|1.005|1.238|||||test/reference = caffeine+DAC HYP/caffeine|Pairwise comparison: caffeine. Based on linear mixed model with fixed effect for treatment and random effect for participants. Excludes participants with high predose concentration (\>5% of Cmax).||1.238|1.005|
72571149|NCT01462318|144670721|SUPERIORITY_OR_OTHER||ratio|0.878|||||TWO_SIDED|90.0|0.697|1.105|||||test/reference = omeprazole+DAC HYP/omeprazole|Pairwise comparison: omeprazole. Based on linear mixed model with fixed effect for treatment and random effect for participants.||1.105|0.697|
72406637|NCT01948375|144321902|SUPERIORITY_OR_OTHER||||||=|0.006||||||"for the comparison of difference of acupuncture pain in two periods between the two groups,t=-2.88, p=0.006.~t=-2.88 refers to the t value of t test."|t-test, 2 sided|||||||=0.006
72406638|NCT01948375|144321903|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.63|||=|0.048||95.0|1.01|2.64||For the comparison of direct effect of placebo needle and real needle, p=0.048|Generalized Estimating Equation|||||2.64|1.01|=0.048
72406639|NCT04537806|144321906|SUPERIORITY||Proc Genmod|0.0||||1|TWO_SIDED|95.0|-31.8|31.8|||Chi-squared||Estimates for treatment, and the corresponding 95% confidence interval (CI) were estimated using Proc Genmod method, with treatment as a factor and age groups as a covariate variable.|||31.8|-31.8|1.0000
72406640|NCT03019627|144321909|SUPERIORITY||difference in least square means|-3.83|||=|0.428|TWO_SIDED|95.0|-13.34|5.68|||ANCOVA|||Frequency statistical analysis||5.68|-13.34|=0.428
72406641|NCT03019627|144321909|SUPERIORITY||difference in least square means|0.16|||=|0.974|TWO_SIDED|95.0|-9.45|9.76|||ANCOVA|||Severity statistical analysis||9.76|-9.45|=0.974
72525333|NCT01996865|144581115|OTHER||Hazard Ratio (HR)|0.7||||0.1222|TWO_SIDED|95.0|0.4|1.1|||Regression, Cox|||||1.1|0.4|0.1222
72525334|NCT03733132|144581161|SUPERIORITY|||||||0.854|||||||t-test, 2 sided|||||||0.854
72525335|NCT03733132|144581162|SUPERIORITY|||||||0.389|||||||t-test, 2 sided|||||||0.389
72525336|NCT03733132|144581163|SUPERIORITY|||||||0.609|||||||t-test, 2 sided|||||||0.609
72525337|NCT03733132|144581164|SUPERIORITY|||||||0.371|||||||t-test, 2 sided|||||||0.371
72525338|NCT03733132|144581165|SUPERIORITY|||||||0.686|||||||t-test, 2 sided|||||||0.686
72525339|NCT01426009|144581254|SUPERIORITY|Day 7 analysis|Least Squares Mean Difference (SE)|0.0723|STANDARD_ERROR_OF_MEAN|0.0188||0.0003|TWO_SIDED|95.0|0.0347|0.1099|||ANCOVA||Standard Error of the Mean Difference|An ANCOVA was used with change from baseline in trough FEV1 as the response,with factors for treatment, period, sequence, baseline as a covariate and a random effect for subject nested within sequence. A sample size of 30 subjects per comparison(133 total with dropouts)provides 90% power to detect a 0.12L difference in mean change trough FEV1 between active and placebo at an alpha of 0.05 using a 2-tailed t-test and assuming a within-subject standard deviation for change in trough FEV1 of 0.2.||0.1099|0.0347|0.0003
72406642|NCT03019627|144321910|SUPERIORITY||Difference in least square means|-1.12|||=|0.783|TWO_SIDED|95.0|-9.14|6.91|||ANCOVA|||frequency statistical analysis - week 4||6.91|-9.14|=0.783
72406643|NCT03019627|144321910|SUPERIORITY||difference in least square means|-3.82|||=|0.461|TWO_SIDED|95.0|-14.1|6.41|||ANCOVA|||Frequency statistical analysis - week 8||6.41|-14.1|=0.461
72525340|NCT01426009|144581254|SUPERIORITY|Day 7 analysis|Least Squares Mean Difference (SE)|0.0676|STANDARD_ERROR_OF_MEAN|0.0184||0.0006|TWO_SIDED|95.0|0.0307|0.1046|||ANCOVA||Standard Error of the Mean Difference|An ANCOVA was used with change from baseline in trough FEV1 as the response,with factors for treatment, period, sequence, baseline as a covariate and a random effect for subject nested within sequence.A sample size of 30 subjects per comparison(133 total with dropouts)provides 90% power to detect a 0.12L difference in mean change trough FEV1 between active and placebo at an alpha of 0.05 using a 2-tailed t-test and assuming a within-subject standard deviation for change in trough FEV1 of 0.2.||0.1046|0.0307|0.0006
72525341|NCT01426009|144581254|SUPERIORITY|Day 7 analysis|Least Squares Mean Difference (SE)|0.1021|STANDARD_ERROR_OF_MEAN|0.0188|<|0.0001|TWO_SIDED|95.0|0.0644|0.1398|||ANCOVA||Standard Error of the Mean Difference|An ANCOVA was used with change from baseline in trough FEV1 as the response, with factors for treatment, period, sequence, baseline as a covariate and a random effect for subject nested within sequence.A sample size of 30 subjects per comparison(133 total with dropouts)provides 90% power to detect a 0.12L difference in mean change trough FEV1 between active and placebo at an alpha of 0.05 using a 2-tailed t-test and assuming a within-subject standard deviation for change in trough FEV1 of 0.2.||0.1398|0.0644|<0.0001
72525342|NCT01426009|144581254|SUPERIORITY|Day 7 analysis|Least Squares Mean Difference (SE)|0.1299|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001|TWO_SIDED|95.0|0.0918|0.1681|||ANCOVA||Standard Error of the Mean Difference|An ANCOVA was used with change from baseline in trough FEV1 as the response, with factors for treatment, period, sequence, baseline as a covariate and a random effect for subject nested within sequence.A sample size of 30 subjects per comparison(133 total with dropouts)provides 90% power to detect a 0.12L difference in mean change trough FEV1 between active and placebo at an alpha of 0.05 using a 2-tailed t-test and assuming a within-subject standard deviation for change in trough FEV1 of 0.2.||00.1681|0.0918|<0.0001
72571150|NCT00667810|144670753|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.83||||0.057|TWO_SIDED|95.0|-3.71|0.05||The p-value is not adjusted for multiple comparison. The Hochberg approach is used to control for multiplicity between the two dose levels (0.5 mg/kg and 1.0 mg/kg) of bapineuzumab.|Mixed Models Analysis|||Change from baseline in ADAS-Cog/11 total score was analyzed using a restricted maximum likelihood (REML) based mixed model for repeated-measures (MMRM). The number of participants in each group provided approximately 90% power to detect a 2.65 point advantage at Week 78. This calculation was based on a 2-sided test with alpha set at 0.05, the use of the Hochberg procedure to control for multiplicity.||0.05|-3.71|0.057
72576759|NCT00261443|144680646|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.544||||0.014|TWO_SIDED|95.0|0.332|0.893||Stratified Log-rank Test, controlling for type of mood stabilizer and type of mood episode|Stratified Log-rank Test||Cox proportional hazards model, with type of mood stabilizer and type of index mood episode as stratification factors, and treatment group as covariate.|||0.893|0.332|0.014
72406644|NCT03019627|144321910|SUPERIORITY||difference in least square means|-15.3|||=|0.004|TWO_SIDED|95.0|-25.6|-4.97|||ANCOVA|||Frequency statistical analysis - week 12||-4.97|-25.6|=0.004
72406645|NCT03019627|144321910|SUPERIORITY||difference in least square means|2.55|||=|0.544|TWO_SIDED|95.0|-5.72|10.82|||ANCOVA|||Severity statistical analysis - week 4||10.82|-5.72|=0.544
72525343|NCT01426009|144581254|SUPERIORITY|Day 7 analysis|Least Squares Mean Difference (SE)|0.0446|STANDARD_ERROR_OF_MEAN|0.0186||0.02|TWO_SIDED|95.0|0.0073|0.082|||Mantel Haenszel||Standard Error of the Mean Difference|An ANCOVA was used with change from baseline in trough FEV1 as the response, with factors for treatment, period, sequence, baseline as a covariate and a random effect for subject nested within sequence.A sample size of 30 subjects per comparison(133 total with dropouts)provides 90% power to detect a 0.12L difference in mean change trough FEV1 between active and placebo at an alpha of 0.05 using a 2-tailed t-test and assuming a within-subject standard deviation for change in trough FEV1 of 0.2.||0.0820|0.0073|0.0200
72571151|NCT00667810|144670753|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.19||||0.848|TWO_SIDED|95.0|-1.73|2.1||The p-value is not adjusted for multiple comparison. The Hochberg approach is used to control for multiplicity between the two dose levels (0.5 mg/kg and 1.0 mg/kg) of bapineuzumab.|Mixed Models Analysis|||Change from baseline in ADAS-Cog/11 total score was analyzed using a REML based MMRM. The number of participants in each group provided approximately 90% power to detect a 2.65 point advantage at Week 78. This calculation was based on a 2-sided test with alpha set at 0.05, the use of the Hochberg procedure to control for multiplicity.||2.10|-1.73|0.848
72406646|NCT03019627|144321910|SUPERIORITY||difference in least square means|1.06|||=|0.837|TWO_SIDED|95.0|-9.12|11.24|||ANCOVA|||Severity statistical analysis - week 8||11.24|-9.12|=0.837
72525344|NCT01426009|144581254|SUPERIORITY|Day 7 analysis|Least Squares Mean Difference (SE)|0.0813|STANDARD_ERROR_OF_MEAN|0.0284||0.006|TWO_SIDED|95.0|0.0243|0.1382|||ANCOVA||Standard Error of the Mean Difference|An ANCOVA was used with change from baseline in trough FEV1 as the response, with factors for treatment, period, sequence, baseline as a covariate and a random effect for subject nested within sequence.A sample size of 30 subjects per comparison(133 total with dropouts)provides 90% power to detect a 0.12L difference in mean change trough FEV1 between active and placebo at an alpha of 0.05 using a 2-tailed t-test and assuming a within-subject standard deviation for change in trough FEV1 of 0.2.||0.1382|0.0243|0.0060
72406647|NCT03019627|144321910|SUPERIORITY||difference in least square means|-13.8|||=|0.007|TWO_SIDED|95.0|-23.7|3.88|||ANCOVA|||Severity statistical analysis - week 12||3.88|-23.7|=0.007
72406648|NCT03019627|144321911|SUPERIORITY||Difference in least square means|-0.7|||=|0.046|TWO_SIDED|95.0|-1.38|-0.01|||ANCOVA|||week 4||-0.01|-1.38|=0.046
72406649|NCT03019627|144321911|SUPERIORITY||Difference in least square means|-0.3|||=|0.425|TWO_SIDED|95.0|-1.05|0.44|||ANCOVA|||week 8||0.44|-1.05|=0.425
72525345|NCT01426009|144581254|SUPERIORITY|Day 1 analysis|Least Squares Mean Difference (SE)|0.0385|STANDARD_ERROR_OF_MEAN|0.0183||0.0402|TWO_SIDED|95.0|0.0018|0.0752|||ANCOVA||Standard Error of the Mean Difference|An ANCOVA was used with change from baseline in trough FEV1 as the response, with factors for treatment, period, sequence, baseline as a covariate and a random effect for subject nested within sequence.A sample size of 30 subjects per comparison(133 total with dropouts)provides 90% power to detect a 0.12L difference in mean change trough FEV1 between active and placebo at an alpha of 0.05 using a 2-tailed t-test and assuming a within-subject standard deviation for change in trough FEV1 of 0.2.||0.0752|0.0018|0.0402
72525346|NCT01426009|144581254|SUPERIORITY|Day 1 analysis|Least Squares Mean Difference (SE)|0.0696|STANDARD_ERROR_OF_MEAN|0.0179||0.0003|TWO_SIDED|95.0|0.0337|0.1055|||ANCOVA||Standard Error of the Mean Difference|An ANCOVA was used with change from baseline in trough FEV1 as the response, with factors for treatment, period, sequence, baseline as a covariate and a random effect for subject nested within sequence.A sample size of 30 subjects per comparison(133 total with dropouts)provides 90% power to detect a 0.12L difference in mean change trough FEV1 between active and placebo at an alpha of 0.05 using a 2-tailed t-test and assuming a within-subject standard deviation for change in trough FEV1 of 0.2.||0.1055|0.0337|0.0003
72525347|NCT01426009|144581254|SUPERIORITY|Day 1 analysis|Least Squares Mean|0.0501|STANDARD_ERROR_OF_MEAN|0.018||0.0074|TWO_SIDED|95.0|0.014|0.0861|||ANCOVA|||An ANCOVA was used with change from baseline in trough FEV1 as the response, with factors for treatment, period, sequence, baseline as a covariate and a random effect for subject nested within sequence.A sample size of 30 subjects per comparison(133 total with dropouts)provides 90% power to detect a 0.12L difference in mean change trough FEV1 between active and placebo at an alpha of 0.05 using a 2-tailed t-test and assuming a within-subject standard deviation for change in trough FEV1 of 0.2.||0.0861|0.0140|0.0074
72525348|NCT01426009|144581255|SUPERIORITY||Least Squares Mean Difference (SE)|0.0767|STANDARD_ERROR_OF_MEAN|0.0131|<|0.0001|TWO_SIDED|95.0|0.0505|0.1028|||ANCOVA||standard error of the mean difference|ACU 0-24 on Day 1||0.1028|0.0505|<0.0001
72525349|NCT01426009|144581255|SUPERIORITY||Least Squares Mean Difference (SE)|0.122|STANDARD_ERROR_OF_MEAN|0.0127|<|0.0001|TWO_SIDED|95.0|0.0965|0.1475|||ANCOVA||standard error of the Mean difference|ACU 0-24 Day 1||0.1475|0.0965|<0.0001
72525350|NCT01426009|144581255|SUPERIORITY||Least Squares Mean Difference (SE)|0.1222|STANDARD_ERROR_OF_MEAN|0.0128|<|0.0001|TWO_SIDED|95.0|0.0965|0.1479|||ANCOVA||standard error of the Mean difference|AUC 0-24 Day 1||0.1479|0.0965|<0.0001
72525351|NCT01426009|144581255|SUPERIORITY||Least Squares Mean Difference (SE)|0.1625|STANDARD_ERROR_OF_MEAN|0.0131|<|0.0001|TWO_SIDED|95.0|0.1362|0.1888|||ANCOVA||standard error of the Mean difference|AUC 0-24 day 1||0.1888|0.1362|<0.0001
72525352|NCT01426009|144581255|SUPERIORITY||Least Squares Mean Difference (SE)|0.169|STANDARD_ERROR_OF_MEAN|0.0128|<|0.0001|TWO_SIDED|95.0|0.1434|0.1946|||ANCOVA||standard error of the Mean difference|AUC 0-24 day 1||0.1946|0.1434|<0.0001
72525353|NCT01426009|144581255|SUPERIORITY||Least Squares Mean Difference (SE)|0.1095|STANDARD_ERROR_OF_MEAN|0.0189|<|0.0001|TWO_SIDED|95.0|0.0716|0.1473|||ANCOVA||standard error of the Mean difference|AUC 0-24 day 1||0.1473|0.0716|<0.0001
72525354|NCT01426009|144581255|SUPERIORITY||Least Squares Mean Difference (SE)|0.1095|STANDARD_ERROR_OF_MEAN|0.0141|<|0.0001|TWO_SIDED|95.0|0.0812|0.1379|||ANCOVA||standard error of the Mean difference|AUC 0-24 on Day 7||0.1379|0.0812|<0.0001
72406650|NCT03019627|144321911|SUPERIORITY||Difference in least square means|-0.09|||=|0.788|TWO_SIDED|95.0|-0.76|0.58|||ANCOVA|||week 12||0.58|-0.76|=0.788
72406651|NCT03019627|144321912|SUPERIORITY||Difference in least square means|-0.71|||=|0.265|TWO_SIDED|95.0|-1.95|0.54|||ANCOVA|||week 4||0.54|-1.95|=0.265
72406652|NCT03019627|144321912|SUPERIORITY||Difference in least square means|-1.38|||=|0.026|TWO_SIDED|95.0|-2.59|-0.17|||ANCOVA|||week 8||-0.17|-2.59|=0.026
72525355|NCT01426009|144581255|SUPERIORITY||Least Squares Mean Difference (SE)|0.1271|STANDARD_ERROR_OF_MEAN|0.0139|<|0.0001|TWO_SIDED|95.0|0.0993|0.1548|||ANCOVA||standard error of the Mean difference|AUC0-24 on Day 7||0.1548|0.0993|<0.0001
72571152|NCT00667810|144670754|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.51||||0.459|TWO_SIDED|95.0|-2.48|5.49||The p-value is not adjusted for multiple comparison. The Hochberg approach is used to control for multiplicity between the two dose levels (0.5 mg/kg and 1.0 mg/kg) of bapineuzumab.|Mixed Models Analysis|||Change from baseline in DAD total score was analyzed using a REML based MMRM. The number of participants in each group provided approximately 90% power to detect a 6.56 point advantage at Week 78. This calculation was based on a 2-sided test with alpha set at 0.05, the use of the Hochberg procedure to control for multiplicity.||5.49|-2.48|0.459
72571153|NCT00667810|144670754|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.01||||0.623|TWO_SIDED|95.0|-3.04|5.07||The p-value is not adjusted for multiple comparison. The Hochberg approach is used to control for multiplicity between the two dose levels (0.5 mg/kg and 1.0 mg/kg) of bapineuzumab.|Mixed Models Analysis|||Change from baseline in DAD total score was analyzed using a REML based MMRM. The number of participants in each group provided approximately 90% power to detect a 6.56 point advantage at Week 78. This calculation was based on a 2-sided test with alpha set at 0.05, the use of the Hochberg procedure to control for multiplicity.||5.07|-3.04|0.623
72571154|NCT00667810|144670755|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.03||||0.654|TWO_SIDED|95.0|-0.15|0.09|||Mixed Models Analysis|||The analysis is based on the pooled bapineuzumab (with subjects in the bapineuzumab 0.5 and 1.0 mg/kg groups combined) treatment difference estimated at Week 71. The number of participants gave 90% power to detect a 0.186 unit advantage for a bapineuzumab dose group over placebo for PiB PET binding at Week 71. The calculations were based on 2-sided tests with alpha set at 0.05 and the use of the Hochberg procedure to control for multiplicity for 2 individual doses.||0.09|-0.15|0.654
72571155|NCT00667810|144670756|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.18||||0.085|TWO_SIDED|95.0|-15.38|1.02|||ANCOVA|||The analysis is based on the pooled bapineuzumab (with subjects in the bapineuzumab 0.5 and 1.0 mg/kg groups combined) treatment difference estimated at Week 71. The number of participants gave 90% power to detect a 15 ng/L advantage in p-tau for a bapineuzumab dose group over placebo at Week 71. The calculations were based on 2-sided tests with alpha set at 0.05 and the use of the Hochberg procedure to control for multiplicity for 2 individual doses.||1.02|-15.38|0.085
72571156|NCT00667810|144670757|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.01||||0.437|TWO_SIDED|95.0|-1.55|3.57|||Mixed Models Analysis|||Change in MRI BBSI was analyzed using a REML based MMRM. The number of participants gave 90% power to detect a 5.05-cm3 advantage for a bapineuzumab dose group over placebo on reduction in brain volume as measured by the BBSI at Week 71. The calculations were based on 2-sided tests with alpha set at 0.05 and the use of the Hochberg procedure to control for multiplicity for 2 individual doses.||3.57|-1.55|0.437
72406653|NCT03019627|144321912|SUPERIORITY||Difference in least square means|-0.6|||=|0.361|TWO_SIDED|95.0|-1.9|0.7|||ANCOVA|||week 12||0.70|-1.90|=0.361
72406654|NCT03019627|144321913|SUPERIORITY||Difference in least square means|-0.25|||=|0.323|TWO_SIDED|95.0|-0.76|0.25|||ANCOVA|||week 4||0.25|-0.76|=0.323
72525356|NCT01426009|144581255|SUPERIORITY||Least Squares Mean Difference (SE)|0.145|STANDARD_ERROR_OF_MEAN|0.014|<|0.0001|TWO_SIDED|95.0|0.1169|0.173|||ANCOVA||standard error of the Mean difference|AUC 0-24 on day 7||0.1730|0.1169|<0.0001
72525357|NCT01426009|144581255|SUPERIORITY||Least Squares Mean Difference (SE)|0.1688|STANDARD_ERROR_OF_MEAN|0.0142|<|0.0001|TWO_SIDED|95.0|0.1403|0.1972|||ANCOVA||standard error of the Mean difference|AUC 0-24 on day 7||0.1972|0.1403|<0.0001
72525358|NCT01426009|144581255|SUPERIORITY||Least Squares Mean Difference (SE)|0.1396|STANDARD_ERROR_OF_MEAN|0.0139|<|0.0001|TWO_SIDED|95.0|0.1117|0.173|||ANCOVA||standard error of the Mean difference|AUC 0-24 on day 7||0.1730|0.1117|<0.0001
72525359|NCT01426009|144581255|SUPERIORITY||Least Squares Mean Difference (SE)|0.1183|STANDARD_ERROR_OF_MEAN|0.0194|<|0.0001|TWO_SIDED|95.0|0.0795|0.1972|||ANCOVA||standard error of the Mean difference|AUC 0-24 on day 7||0.1972|0.0795|<0.0001
72525360|NCT01426009|144581255|SUPERIORITY||Least Squares Mean Difference (SE)|0.1038|STANDARD_ERROR_OF_MEAN|0.0131|<|0.0001|TWO_SIDED|95.0|0.0776|0.1301|||ANCOVA||standard error of the Mean difference|AUC 0-12 on day 1||0.1301|0.0776|<0.0001
72525361|NCT01426009|144581255|SUPERIORITY||Least Squares Mean Difference (SE)|0.1468|STANDARD_ERROR_OF_MEAN|0.0128|<|0.0001|TWO_SIDED|95.0|0.1212|0.1724|||ANCOVA||standard error of the Mean difference|AUC 0-12 on day 1||0.1724|0.1212|<0.0001
72525362|NCT01426009|144581255|SUPERIORITY||Least Squares Mean Difference (SE)|0.1579|STANDARD_ERROR_OF_MEAN|0.0128|<|0.0001|TWO_SIDED|95.0|0.1322|0.1837|||ANCOVA||standard error of the Mean difference|AUC 0-12 on day 1||0.1837|0.1322|<0.0001
72525363|NCT01426009|144581255|SUPERIORITY||Least Squares Mean Difference (SE)|0.1919|STANDARD_ERROR_OF_MEAN|0.0132|<|0.0001|TWO_SIDED|95.0|0.1655|0.2184|||ANCOVA||standard error of the Mean difference|AUC 0-12 on day 1||0.2184|0.1655|<0.0001
72525364|NCT01426009|144581255|SUPERIORITY||Least Squares Mean Difference (SE)|0.1994|STANDARD_ERROR_OF_MEAN|0.0128|<|0.0001|TWO_SIDED|95.0|0.1738|0.2251|||ANCOVA||standard error of the Mean difference|AUC 0-12 on day 1||0.2251|0.1738|<0.0001
72525365|NCT01426009|144581255|SUPERIORITY||Least Squares Mean Difference (SE)|0.1248|STANDARD_ERROR_OF_MEAN|0.0188|<|0.0001|TWO_SIDED|95.0|0.0872|0.1625|||ANCOVA||standard error of the Mean difference|AUC 0-12 on day 1||0.1625|0.0872|<0.0001
72525366|NCT01426009|144581255|SUPERIORITY||Least Squares Mean Difference (SE)|0.1279|STANDARD_ERROR_OF_MEAN|0.0154|<|0.0001|TWO_SIDED|95.0|0.097|0.1587|||ANCOVA|standard error of the Mean difference|standard error of the Mean difference|AUC 0-12 on day 7||0.1587|0.0970|<0.0001
72525367|NCT01426009|144581255|SUPERIORITY||Least Squares Mean Difference (SE)|0.1454|STANDARD_ERROR_OF_MEAN|0.0151|<|0.0001|TWO_SIDED|95.0|0.1151|0.1756|||ANCOVA||standard error of the Mean difference|AUC 0-12 on day 7||0.1756|0.1151|<0.0001
72525368|NCT01426009|144581255|SUPERIORITY||Least Squares Mean Difference (SE)|0.1699|STANDARD_ERROR_OF_MEAN|0.0152|<|0.0001|TWO_SIDED|95.0|0.1393|0.2004|||ANCOVA||standard error of the Mean difference|AUC 0-12 on day 7||0.2004|0.1393|<0.0001
72625251|NCT01098747|144780082|SUPERIORITY_OR_OTHER||LS mean difference|-0.3||||0.703|TWO_SIDED|95.0|-1.84|1.24||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||TOTPAR 0-6: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.24|-1.84|0.703
72625252|NCT01098747|144780082|SUPERIORITY_OR_OTHER||LS mean difference|14.27|||<|0.001|TWO_SIDED|95.0|11.36|17.18||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||TOTPAR 0-8: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||17.18|11.36|<0.001
72525369|NCT01426009|144581255|SUPERIORITY||Least Squares Mean Difference (SE)|0.1814|STANDARD_ERROR_OF_MEAN|0.0155|<|0.0001|TWO_SIDED|95.0|0.1503|0.2125|||ANCOVA||standard error of the Mean difference|AUC 0-12 on day 7||0.2125|0.1503|<0.0001
72525370|NCT01426009|144581255|SUPERIORITY||Least Squares Mean Difference (SE)|0.1697|STANDARD_ERROR_OF_MEAN|0.0152|<|0.0001|TWO_SIDED|95.0|0.1393|0.201|||ANCOVA||standard error of the Mean difference|AUC 0-12 on day 7||0.201|0.1393|<0.0001
72525371|NCT01426009|144581255|SUPERIORITY||Least Squares Mean Difference (SE)|0.1384|STANDARD_ERROR_OF_MEAN|0.0216|<|0.0001|TWO_SIDED|95.0|0.0951|0.1817|||ANCOVA||standard error of the Mean difference|AUC 0-12 on day 7||0.1817|0.0951|<0.0001
72625253|NCT01098747|144780082|SUPERIORITY_OR_OTHER||LS mean difference|-1.1||||0.303|TWO_SIDED|95.0|-3.2|1.0||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||TOTPAR 0-8: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.00|-3.20|0.303
72525372|NCT01426009|144581255|SUPERIORITY||Least Squares Mean Difference (SE)|0.0471|STANDARD_ERROR_OF_MEAN|0.0157|<|0.0001|TWO_SIDED|95.0|0.0155|0.0786|||ANCOVA||standard error of the Mean difference|AUC 12-24 on day 1||0.0786|0.0155|<0.0001
72525373|NCT01426009|144581255|SUPERIORITY||Least Squares Mean Difference (SE)|0.0918|STANDARD_ERROR_OF_MEAN|0.0154|<|0.0001|TWO_SIDED|95.0|0.0611|0.1226|||ANCOVA||standard error of the Mean difference|AUC 12-24 on day 1||0.1226|0.0611|<0.0001
72525374|NCT01426009|144581255|SUPERIORITY||Least Squares Mean Difference (SE)|0.0829|STANDARD_ERROR_OF_MEAN|0.0155|<|0.0001|TWO_SIDED|95.0|0.0519|0.1139|||ANCOVA||standard error of the Mean difference|AUC 12-24 on day 1||0.1139|0.0519|<0.0001
72525375|NCT01426009|144581255|SUPERIORITY||Least Squares Mean Difference (SE)|0.1299|STANDARD_ERROR_OF_MEAN|0.0158|<|0.0001|TWO_SIDED|95.0|0.0982|0.1617|||ANCOVA||standard error of the Mean difference|AUC 12-24 o day 1||0.1617|0.0982|<0.0001
72525376|NCT01426009|144581255|SUPERIORITY||Least Squares Mean Difference (SE)|0.1369|STANDARD_ERROR_OF_MEAN|0.0154|<|0.0001|TWO_SIDED|95.0|0.1061|0.1678|||ANCOVA||standard error of the Mean difference|AUC 12-24 on day 1||0.1678|0.1061|<0.0001
72525377|NCT01426009|144581255|SUPERIORITY||Least Squares Mean Difference (SE)|0.0934|STANDARD_ERROR_OF_MEAN|0.0221|<|0.0001|TWO_SIDED|95.0|0.049|0.1377|||ANCOVA||standard error of the Mean difference|AUC 12-24 on day 1||0.1377|0.0490|<0.0001
72525378|NCT01426009|144581255|SUPERIORITY||Least Squares Mean Difference (SE)|0.0879|STANDARD_ERROR_OF_MEAN|0.0153|<|0.0001|TWO_SIDED|95.0|0.0573|0.1186|||ANCOVA||standard error of the Mean difference|AUC 12-24 on day 7||0.1186|0.0573|<0.0001
72525379|NCT01426009|144581255|SUPERIORITY||Least Squares Mean Difference (SE)|0.1088|STANDARD_ERROR_OF_MEAN|0.015|<|0.0001|TWO_SIDED|95.0|0.0788|0.1388|||ANCOVA||standard error of the Mean difference|AUC 12-24 on day 7||0.1388|0.0788|<0.0001
72525380|NCT01426009|144581255|SUPERIORITY||Least Squares Mean Difference (SE)|0.1175|STANDARD_ERROR_OF_MEAN|0.0151|<|0.0001|TWO_SIDED|95.0|0.0872|0.1478|||ANCOVA||standard error of the Mean difference|AUC 12-24 on day 7||0.1478|0.0872|<0.0001
72525381|NCT01426009|144581255|SUPERIORITY||Least Squares Mean Difference (SE)|0.1532|STANDARD_ERROR_OF_MEAN|0.0153|<|0.0001|TWO_SIDED|95.0|0.1226|0.1838|||ANCOVA||standard error of the Mean difference|||0.1838|0.1226|<0.0001
72525382|NCT01426009|144581255|SUPERIORITY||Least Squares Mean Difference (SE)|0.1048|STANDARD_ERROR_OF_MEAN|0.015|<|0.0001|TWO_SIDED|95.0|0.0747|0.135|||ANCOVA||standard error of the Mean difference|||0.1350|0.0747|<0.0001
72525383|NCT01426009|144581255|SUPERIORITY||Least Squares Mean Difference (SE)|0.0993|STANDARD_ERROR_OF_MEAN|0.0202|<|0.0001|TWO_SIDED|95.0|0.0589|0.1398|||ANCOVA||standard error of the Mean difference|AUC 12-24 on day 7||0.1398|0.0589|<0.0001
72625254|NCT01098747|144780083|SUPERIORITY_OR_OTHER||LS mean difference|6.68|||<|0.001|TWO_SIDED|95.0|5.6|7.76||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPRID 0-2: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS mean from the ANOVA model.||7.76|5.60|<0.001
72525384|NCT04476108|144581304|SUPERIORITY||Posterior Mean Difference|-0.42|||||TWO_SIDED|95.0|-1.17|0.32|||Bayesian Mixed Model Analysis||The Bayesian analyses include posterior probabilities instead of p-values, and 95% credible intervals instead of 95% confidence intervals.|||0.32|-1.17|
72525385|NCT04476108|144581305|SUPERIORITY||Posterior Mean Difference|-0.37|||||TWO_SIDED|95.0|-1.09|0.35|||Bayesian Mixed Model Analysis||The Bayesian analyses include posterior probabilities instead of p-values, and 95% credible intervals instead of 95% confidence intervals.|||0.35|-1.09|
72525386|NCT04476108|144581306|SUPERIORITY||Posterior Mean Difference|-0.27|||||TWO_SIDED|95.0|-0.69|0.15|||Bayesian Mixed Model Analysis||The Bayesian analyses include posterior probabilities instead of p-values, and 95% credible intervals instead of 95% confidence intervals.|||0.15|-0.69|
72525387|NCT04476108|144581307|SUPERIORITY||Posterior Mean Difference|-0.44|||||TWO_SIDED|95.0|-1.2|0.31|||Bayesian Mixed Model Analysis||The Bayesian analyses include posterior probabilities instead of p-values, and 95% credible intervals instead of 95% confidence intervals.|||0.31|-1.20|
72525388|NCT04476108|144581308|SUPERIORITY||Posterior Mean Difference|-2.86|||||TWO_SIDED|95.0|-11.71|6.06|||Bayesian Mixed Model Analysis||The Bayesian analyses include posterior probabilities instead of p-values, and 95% credible intervals instead of 95% confidence intervals.|||6.06|-11.71|
72525389|NCT04476108|144581309|SUPERIORITY||Posterior Mean Difference|0.35|||||TWO_SIDED|95.0|-0.09|0.78|||Bayesian Mixed Model Analysis||The Bayesian analyses include posterior probabilities instead of p-values, and 95% credible intervals instead of 95% confidence intervals.|||0.78|-0.09|
72625255|NCT01098747|144780083|SUPERIORITY_OR_OTHER||LS mean difference|1.06||||0.007|TWO_SIDED|95.0|0.29|1.84||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPRID 0-2: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS mean from the ANOVA model.||1.84|0.29|0.007
72625256|NCT01098747|144780083|SUPERIORITY_OR_OTHER||LS mean difference|10.43|||<|0.001|TWO_SIDED|95.0|8.79|12.08||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPRID 0-3: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS mean from the ANOVA model.||12.08|8.79|<0.001
72406655|NCT03019627|144321913|SUPERIORITY||Difference in least square means|0.03|||=|0.908|TWO_SIDED|95.0|-0.55|0.62|||ANCOVA|||week 8||0.62|-0.55|=0.908
72525390|NCT04476108|144581310|SUPERIORITY||Posterior Mean Difference|0.34|||||TWO_SIDED|95.0|-188.46|187.97|||Bayesian Mixed Model Analysis||The Bayesian analyses include posterior probabilities instead of p-values, and 95% credible intervals instead of 95% confidence intervals.|||187.97|-188.46|
72525391|NCT04476108|144581311|SUPERIORITY||Posterior Mean Difference|0.04|||||TWO_SIDED|95.0|-0.01|0.1|||Bayesian Mixed Model Analysis||The Bayesian analyses include posterior probabilities instead of p-values, and 95% credible intervals instead of 95% confidence intervals.|||0.10|-0.01|
72525392|NCT04716010|144581414|SUPERIORITY|||||||0.002||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||0.002
72525393|NCT04716010|144581414|SUPERIORITY||||||<|0.001||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.001
72525394|NCT04716010|144581414|SUPERIORITY||||||<|0.001||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.001
72525395|NCT04716010|144581414|SUPERIORITY|||||||0.024||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||0.024
72525396|NCT04716010|144581414|SUPERIORITY||||||<|0.001||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.001
72525397|NCT04716010|144581414|SUPERIORITY||||||<|0.001||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.001
72525398|NCT04716010|144581415|SUPERIORITY|||||||0.001||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||0.001
72525399|NCT04716010|144581415|SUPERIORITY||||||<|0.001||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.001
72525400|NCT04716010|144581415|SUPERIORITY||||||<|0.001||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.001
72525401|NCT04716010|144581415|SUPERIORITY|||||||0.022||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||0.022
72525402|NCT04716010|144581415|SUPERIORITY||||||<|0.001||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.001
72525403|NCT04716010|144581415|SUPERIORITY||||||<|0.001||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.001
72525404|NCT04716010|144581416|SUPERIORITY||||||>|0.05||||||The a priori threshold for statistical significance is \>0.05|Regression, Linear|||||||>0.05
72525405|NCT04716010|144581416|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
72525406|NCT04716010|144581416|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
72525407|NCT04716010|144581416|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
72525408|NCT04716010|144581416|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
72406656|NCT03019627|144321913|SUPERIORITY||Difference in least square means|-0.12|||=|0.702|TWO_SIDED|95.0|-0.76|0.52|||ANCOVA|||week 12||0.52|-0.76|=0.702
72525409|NCT04716010|144581416|SUPERIORITY||||||>|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||>0.05
72525410|NCT04716010|144581417|SUPERIORITY||||||>|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||>0.05
72525411|NCT04716010|144581417|SUPERIORITY||||||>|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||>0.05
72525412|NCT04716010|144581417|SUPERIORITY||||||>|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||>0.05
72525413|NCT04716010|144581417|SUPERIORITY||||||>|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||>0.05
72525414|NCT04716010|144581417|SUPERIORITY||||||>|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||>0.05
72525415|NCT04716010|144581417|SUPERIORITY||||||>|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||>0.05
72525416|NCT04716010|144581418|SUPERIORITY||||||>|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||>0.05
72525417|NCT04716010|144581418|SUPERIORITY||||||>|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||>0.05
72525418|NCT04716010|144581418|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
72525419|NCT04716010|144581418|SUPERIORITY||||||>|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||>0.05
72525420|NCT04716010|144581418|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
72525421|NCT04716010|144581418|SUPERIORITY||||||>|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||>0.05
72525422|NCT04716010|144581419|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
72525423|NCT04716010|144581419|SUPERIORITY||||||>|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||>0.05
72525424|NCT04716010|144581419|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
72525425|NCT04716010|144581419|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
72525426|NCT04716010|144581419|SUPERIORITY||||||>|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||>0.05
72525427|NCT04716010|144581419|SUPERIORITY||||||<|0.05|||||||Regression, Linear|||||||<0.05
72625257|NCT01098747|144780083|SUPERIORITY_OR_OTHER||LS mean difference|0.87||||0.152|TWO_SIDED|95.0|-0.32|2.05||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPRID 0-3: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS mean from the ANOVA model.||2.05|-0.32|0.152
72625258|NCT01098747|144780083|SUPERIORITY_OR_OTHER||LS mean difference|19.83|||<|0.001|TWO_SIDED|95.0|16.23|23.43||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPRID 0-6: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS mean from the ANOVA model.||23.43|16.23|<0.001
72625259|NCT01098747|144780083|SUPERIORITY_OR_OTHER||LS mean difference|-0.53||||0.69|TWO_SIDED|95.0|-3.12|2.07||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPRID 0-6: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS mean from the ANOVA model.||2.07|-3.12|0.690
72525428|NCT04716010|144581420|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
72525429|NCT04716010|144581420|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
72525430|NCT04716010|144581420|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
72525431|NCT04716010|144581420|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
72525432|NCT04716010|144581420|SUPERIORITY||||||>|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||>0.05
72525433|NCT04716010|144581420|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
72525434|NCT04716010|144581421|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
72525435|NCT04716010|144581421|SUPERIORITY||||||>|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||>0.05
72525436|NCT04716010|144581421|SUPERIORITY||||||>|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||>0.05
72525437|NCT04716010|144581421|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
72525438|NCT04716010|144581421|SUPERIORITY||||||>|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||>0.05
72525439|NCT04716010|144581421|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
72525440|NCT04716010|144581422|SUPERIORITY||||||>|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||>0.05
72525441|NCT04716010|144581422|SUPERIORITY||||||>|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||>0.05
72525442|NCT04716010|144581422|SUPERIORITY||||||>|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||>0.05
72525443|NCT04716010|144581422|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
72525444|NCT04716010|144581422|SUPERIORITY||||||>|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||>0.05
72525445|NCT04716010|144581422|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
72525446|NCT04716010|144581423|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
72525447|NCT04716010|144581423|SUPERIORITY||||||>|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||>0.05
72525448|NCT04716010|144581423|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
72525449|NCT04716010|144581423|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
72525450|NCT04716010|144581423|SUPERIORITY||||||>|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||>0.05
72525451|NCT04716010|144581423|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
72525452|NCT04716010|144581424|SUPERIORITY||||||>|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||>0.05
72525453|NCT04716010|144581424|SUPERIORITY||||||>|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||>0.05
72525454|NCT04716010|144581424|SUPERIORITY||||||>|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||>0.05
72525455|NCT04716010|144581424|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
72525456|NCT04716010|144581424|SUPERIORITY||||||>|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||>0.05
72525457|NCT04716010|144581424|SUPERIORITY||||||>|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||>0.05
72525458|NCT04716010|144581425|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
72525459|NCT04716010|144581425|SUPERIORITY||||||>|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||>0.05
72625260|NCT01098747|144780083|SUPERIORITY_OR_OTHER||LS mean difference|-1.77||||0.323|TWO_SIDED|95.0|-5.29|1.75||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPRID 0-8 Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS mean from the ANOVA model.||1.75|-5.29|0.323
72406657|NCT03019627|144321914|SUPERIORITY||Difference in least square means|5.75|||=|0.003|TWO_SIDED|95.0|2.02|9.48|||ANCOVA|||||9.48|2.02|=0.003
72525460|NCT04716010|144581425|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
72525461|NCT04716010|144581425|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
72525462|NCT04716010|144581425|SUPERIORITY||||||>|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||>0.05
72525463|NCT04716010|144581425|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
72525464|NCT04716010|144581426|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
72525465|NCT04716010|144581426|SUPERIORITY||||||>|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||>0.05
72525466|NCT04716010|144581426|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
72525467|NCT04716010|144581426|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
72525468|NCT04716010|144581426|SUPERIORITY||||||>|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||>0.05
72525469|NCT04716010|144581426|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
72525470|NCT04716010|144581427|SUPERIORITY||||||>|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||>0.05
72525471|NCT04716010|144581427|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
72525472|NCT04716010|144581427|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
72525473|NCT04716010|144581427|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
72525474|NCT04716010|144581427|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
72525475|NCT04716010|144581427|SUPERIORITY||||||>|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||>0.05
72525476|NCT04716010|144581428|SUPERIORITY||||||>|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||>0.05
72525477|NCT04716010|144581428|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
72525478|NCT04716010|144581428|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
72406658|NCT05459129|144321915|SUPERIORITY||Difference in pCR Rates|33.33|||||TWO_SIDED|95.0|-33.23|99.9||||||||99.90|-33.23|
72525479|NCT04716010|144581428|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
72525480|NCT04716010|144581428|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
72525481|NCT04716010|144581428|SUPERIORITY||||||>|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||>0.05
72525482|NCT04716010|144581429|SUPERIORITY||||||>|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||>0.05
72525483|NCT04716010|144581429|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
72525484|NCT04716010|144581429|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
72525485|NCT04716010|144581429|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
72525486|NCT04716010|144581429|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
72406659|NCT05459129|144321916|SUPERIORITY||Difference in pRR|33.33|||||TWO_SIDED|95.0|-21.05|87.72||||||||87.72|-21.05|
72406660|NCT05459129|144321917|SUPERIORITY||Hazard Ratio (HR)|0.65|||||TWO_SIDED|95.0|0.11|3.91|||||HR was estimated by Cox regression. Due to the early termination of the study, the limited sample size and follow-up time no meaningful conclusions can be made in terms of median EFS per arm or HR between the arms.|||3.91|0.11|
72525487|NCT04716010|144581429|SUPERIORITY||||||>|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||>0.05
72525488|NCT04716010|144581430|SUPERIORITY||||||>|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||>0.05
72525489|NCT04716010|144581430|SUPERIORITY||||||>|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||>0.05
72525490|NCT04716010|144581430|SUPERIORITY||||||>|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||>0.05
72525491|NCT04716010|144581430|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
72525492|NCT04716010|144581430|SUPERIORITY||||||>|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||>0.05
72525493|NCT04716010|144581430|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
72525494|NCT04716010|144581431|SUPERIORITY||||||>|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||>0.05
72525495|NCT04716010|144581431|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
72525496|NCT04716010|144581431|SUPERIORITY||||||>|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||>0.05
72525497|NCT04716010|144581431|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
72525498|NCT04716010|144581431|SUPERIORITY||||||>|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||>0.05
72525499|NCT04716010|144581431|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
72525500|NCT04716010|144581432|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
72525501|NCT04716010|144581432|SUPERIORITY||||||>|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||>0.05
72525502|NCT04716010|144581432|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
72525503|NCT04716010|144581432|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
72525504|NCT04716010|144581432|SUPERIORITY||||||>|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||>0.05
72525505|NCT04716010|144581432|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
72525506|NCT04716010|144581433|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
72625261|NCT01098747|144780084|SUPERIORITY_OR_OTHER||Difference in proportion|1.01||||0.49|TWO_SIDED|95.0|-0.97|3.0||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||0.25 hours-Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on Cochran-Mantel-Haenszel (CMH) adjusted proportions and the corresponding standard error.||3.00|-0.97|0.490
72625262|NCT01098747|144780084|SUPERIORITY_OR_OTHER||Difference in proportion|0.54||||0.623|TWO_SIDED|95.0|-1.88|2.95||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||0.25 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||2.95|-1.88|0.623
72525507|NCT04716010|144581433|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
72525508|NCT04716010|144581433|SUPERIORITY||||||>|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||>0.05
72525509|NCT04716010|144581433|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
72525510|NCT04716010|144581433|SUPERIORITY||||||>|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||>0.05
72525511|NCT04716010|144581433|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
72525512|NCT00679380|144581436|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportions|3.8||||0.2876|TWO_SIDED|95.0|-3.0|10.5|||Chi-squared||The difference in proportions was determined by subtracting the proportion of patients who reached the endpoint in the placebo group from that proportion in the active group (active minus placebo).|All p-values were based on the Chi-square test; comparisons of budesonide MMX and placebo were conducted at the α = 0.025 level of significance and the comparison of Entocort EC and placebo were conducted at the α = 0.05 level of significance. The study was not powered to show statistical significance for Entocort EC versus budesonide MMX.||10.5|-3.0|0.2876
72525513|NCT00679380|144581436|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportions|12.9||||0.0047|TWO_SIDED|95.0|4.6|21.3|||Chi-squared||See comments from the budesonide 6 mg versus placebo comparison (statistical analysis 1).|See comments from the budesonide 6 mg versus placebo comparison (statistical analysis 1).||21.3|4.6|0.0047
72525514|NCT00679380|144581436|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportions|8.1||||0.0481|TWO_SIDED|95.0|0.4|15.9|||Chi-squared||See comments from the budesonide 6 mg versus placebo comparison (statistical analysis 1).|See comments from the budesonide 6 mg versus placebo comparison (statistical analysis 1).||15.9|0.4|0.0481
72525515|NCT00679380|144581437|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportions|-8.0||||0.2174|TWO_SIDED|95.0|-20.8||||Chi-squared||The difference in proportions was determined by subtracting the proportion of patients who reached the endpoint in the placebo group from that proportion in the active group (active minus placebo).|Clinical improvement and endoscopic improvement were analyzed hierarchically. If at least one primary endpoint comparison was statistically significant, clinical improvement was to be compared between each budesonide MMX group and placebo at the α = 0.025 level of significance. If at least one comparison of clinical improvement was statistically significant, endoscopic improvement was to be compared between each budesonide MMX dose group and placebo at the α = 0.025 level of significance.||4.|-20.8|0.2174
72525516|NCT00679380|144581437|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportions|8.5||||0.2215|TWO_SIDED|95.0|-5.0|22.0|||Chi-squared||See comments from the budesonide 6 mg versus placebo comparison (statistical analysis 1).|See comments from the budesonide 6 mg versus placebo comparison (statistical analysis 1).||22.0|-5.0|0.2215
72525517|NCT00679380|144581437|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportions|-0.7||||0.9185|TWO_SIDED|95.0|-14.1|12.7|||Chi-squared||See comments from the budesonide 6 mg versus placebo comparison (statistical analysis 1).|See comments from the budesonide 6 mg versus placebo comparison (statistical analysis 1).||12.7|-14.1|0.9185
72525518|NCT00679380|144581438|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportions|5.4||||0.4293|TWO_SIDED|95.0|-8.0|18.8|||Chi-squared||The difference in proportions was determined by subtracting the proportion of patients who reached the endpoint in the placebo group from that proportion in the active group (active minus placebo).|As per the hierarchical testing procedure for secondary endpoints, because clinical improvement was not statistically significant in the ITT population, formal statistical comparisons for endoscopic improvement between the 2 budesonide MMX groups and placebo were not conducted. The statistical comparison between the Entocort EC and placebo groups is shown here.||18.8|-8.0|0.4293
72525519|NCT01833806|144581440|SUPERIORITY||Proportion Difference|0.78|||=|0.01|TWO_SIDED|95.0|0.58|0.98|||Binomial|||The alternative hypothesis test was that the proportion of Responders would be greater than the proportion of subjects experiencing pain progression. This PAS was powered to enroll 70 subjects based on the pivotal trial proportion of 18:8 (Responders:Pain progression). The study was closed at an enrollment of 32 subjects.||0.98|0.58|= 0.01
72525520|NCT02724111|144581443|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
72525521|NCT02724111|144581444|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
72525522|NCT02724111|144581445|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
72406661|NCT05459129|144321918|SUPERIORITY||Hazard Ratio (HR)|0.9|||||TWO_SIDED|95.0|0.13|6.43|||||HR was estimated by Cox regression. Due to the early termination of the study, the limited sample size and follow-up time no meaningful conclusions can be made in terms of media RFS per arm or HR between the arms.|||6.43|0.13|
72406662|NCT05459129|144321920|SUPERIORITY||Difference in ORR|16.67|||||TWO_SIDED|95.0|-54.99|88.32||||||||88.32|-54.99|
72406663|NCT05459129|144321921|SUPERIORITY||Difference in Event Free Rate|16.67|||||TWO_SIDED|95.0|-31.42|64.75|||||Due to the early termination of the study, the limited sample size and follow-up time no meaningful conclusions can be made.|3 Months Analysis||64.75|-31.42|
72525523|NCT02724111|144581446|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
72525524|NCT02724111|144581447|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
72525525|NCT02724111|144581448|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
72525526|NCT02724111|144581449|SUPERIORITY|||||||0.06|||||||t-test, 2 sided|||||||0.06
72571157|NCT00667810|144670757|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.06||||0.423|TWO_SIDED|95.0|-1.54|3.66|||Mixed Models Analysis|||Change in MRI BBSI was analyzed using a REML based MMRM. The number of participants gave 90% power to detect a 5.05-cm3 advantage for a bapineuzumab dose group over placebo on reduction in brain volume as measured by the BBSI at Week 71. The calculations were based on 2-sided tests with alpha set at 0.05 and the use of the Hochberg procedure to control for multiplicity for 2 individual doses.||3.66|-1.54|0.423
72525527|NCT02724111|144581450|SUPERIORITY|||||||0.202|||||||Chi-squared|||||||0.202
72525528|NCT01828567|144581451|OTHER|A logistic regression model was used. The null hypothesis is that there is no difference in improvement prevention program enrollment between the usual care and intervention arms by month 6.|Odds Ratio (OR)|2.54|||<|0.0001|TWO_SIDED|95.0|1.66|3.89|||Regression, Logistic|||The first primary outcome is the cumulative enrollment in prevention programs over the six months of follow up. This will be assessed via self-report at months 1 and 6. As defined by the eligibility criteria, all patients will have a value of 0 at baseline.||3.89|1.66|<.0001
72406664|NCT05459129|144321921|SUPERIORITY||Difference in Event Free Rate|0.0|||||TWO_SIDED|95.0|-53.34|53.34|||||Due to the early termination of the study, the limited sample size and follow-up time no meaningful conclusions can be made.|6 Months Analysis||53.34|-53.34|
72406665|NCT05459129|144321922|SUPERIORITY||Difference in Event Free Rate|-13.33|||||TWO_SIDED|95.0|-64.83|38.16|||||Due to the early termination of the study, the limited sample size and follow-up time no meaningful conclusions can be made|3 Months Analysis||38.16|-64.83|
72406666|NCT05459129|144321922|SUPERIORITY||Difference in Event Free Rate|6.67|||||TWO_SIDED|95.0|-50.49|63.82|||||Due to the early termination of the study, the limited sample size and follow-up time no meaningful conclusions can be made|6 Months Analysis||63.82|-50.49|
72525529|NCT01828567|144581453|OTHER||Mean Difference (Final Values)|1.5||||0.204|TWO_SIDED|95.0|-0.8|3.7||A general linear model with an unstructured covariance matrix to take into account the within-patient correlation between repeated measures over time.|Repeated Measures|This model assumes the groups have equal baseline means.|We estimate the parameters in the model using the SAS procedure MIXED (SAS Version 9.4, Cary, NC). The null hypothesis is that there is no difference in improvement in PAM scores between the usual care and intervention arms at 1 month.|For the primary hypothesis we will be examining the effect during the 1-month long intervention delivery period.||3.7|-0.8|0.204
72525530|NCT01828567|144581454|EQUIVALENCE|This model assumes the groups have equal baseline means, which is appropriate for a randomized controlled trial and is equivalent in efficiency to an ANCOVA model.|Mean Difference (Final Values)|2.5||||0.03|TWO_SIDED|95.0|0.2|4.7||A general Linear model with an unstructured covariance matrix to take into account the within-patient correlation between repeated measures over time. For the primary hypothesis we will be assessing sustainability at 6 months.|Repeated Measures|This model assumes the groups have equal baseline means.|We estimate the parameters in the model using the SAS procedure MIXED (SAS Version 9.4, Cary, NC). The null hypothesis is that there is no difference in improvement in PAM scores between the usual care and intervention arms at 6 month.|||4.7|0.2|0.030
72525531|NCT01828567|144581456|EQUIVALENCE|This model assumes the groups have equal baseline means|Mean Difference (Final Values)|0.7||||0.33|TWO_SIDED|95.0|-0.7|2.2|||Repeated Measures|A general linear model with an unstructured covariance matrix to take into account the within-patient correlation between repeated measures over time.|We estimate the parameters in the model using the SAS procedure MIXED (SAS Version 9.4, Cary, NC). The null hypothesis is that there is no difference in improvement in FRS scores between the usual care and intervention arms at 6 month.|Our secondary outcome of interest is the Framingham Risk Score, measured at baseline and month 6.||2.2|-0.7|0.330
72571158|NCT00667810|144670758|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.32||||0.212|TWO_SIDED|95.0|-3.4|0.76|||Mixed Models Analysis|||||0.76|-3.40|0.212
72571159|NCT00667810|144670758|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.38||||0.725|TWO_SIDED|95.0|-1.76|2.52|||Mixed Models Analysis|||||2.52|-1.76|0.725
72571160|NCT00667810|144670759|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.2||||0.149|TWO_SIDED|95.0|-1.15|7.56|||Mixed Models Analysis|||||7.56|-1.15|0.149
72571161|NCT00667810|144670759|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.01||||0.375|TWO_SIDED|95.0|-2.44|6.46|||Mixed Models Analysis|||||6.46|-2.44|0.375
72571162|NCT00667810|144670760|SUPERIORITY_OR_OTHER|||||||0.03|TWO_SIDED|||||Not specifed.|Log Rank|||||||0.030
72406667|NCT04530552|144321957|OTHER||See above|0.895|||||TWO_SIDED|||||||||Posterior probability of observing a response rate ≥ 50%||||
72571163|NCT00667810|144670760|SUPERIORITY_OR_OTHER|||||||0.567|TWO_SIDED||||||Log Rank|||||||0.567
72571164|NCT00667810|144670761|SUPERIORITY_OR_OTHER|||||||0.079|TWO_SIDED||||||Log Rank|||||||0.079
72571165|NCT00667810|144670761|SUPERIORITY_OR_OTHER|||||||0.675|TWO_SIDED||||||Log Rank|||||||0.675
72571166|NCT00667810|144670762|SUPERIORITY_OR_OTHER|||||||0.846|TWO_SIDED||||||Log Rank|||Not spsecified.||||0.846
72571167|NCT00667810|144670762|SUPERIORITY_OR_OTHER|||||||0.797|TWO_SIDED||||||Log Rank|||||||0.797
72571168|NCT00667810|144670763|SUPERIORITY_OR_OTHER|||||||0.933|TWO_SIDED||||||Log Rank|||||||0.933
72571169|NCT00667810|144670763|SUPERIORITY_OR_OTHER|||||||0.714|TWO_SIDED||||||Log Rank|||||||0.714
72571170|NCT00667810|144670765|SUPERIORITY_OR_OTHER|||||||0.277|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.277
72571171|NCT00667810|144670765|SUPERIORITY_OR_OTHER|||||||0.996|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.996
72525532|NCT01868594|144581493|SUPERIORITY|||||||0.019||||||"The p-value associated with treatment factor of changes from baseline to Week 12, 24 and 36 endpoint between Subetta and Placebo treatment groups. Model includes treatment, visit and treatment\*visit interaction."|Mixed Models Analysis|||||||0.019
72525533|NCT01868594|144581494|SUPERIORITY|||||||0.0432||||||"The p-value associated with treatment factor of changes from baseline to Week 4, 12, 24 and 36 endpoint between Subetta and Placebo treatment groups. Model includes treatment, visit and treatment\*visit interaction."|Mixed Models Analysis|||||||0.0432
72525534|NCT01868594|144581495|SUPERIORITY|||||||0.7344||||||"The p-value associated with treatment factor of changes from baseline to Week 4, 8, 12, 18, 24, 30 and 36 endpoint between Subetta and Placebo treatment groups. Model includes treatment, visit and treatment\*visit interaction."|Mixed Models Analysis|||||||0.7344
72525535|NCT01868594|144581496|SUPERIORITY|||||||0.278||||||"The p-value associated with treatment factor of changes from baseline to Week 12, 24 and 36 endpoint between Subetta and Placebo treatment groups. Model includes treatment, visit and treatment\*visit interaction."|Mixed Models Analysis|||Analysis of Total cholesterol changes from baseline to Week 12, 24 and 36 endpoint between Subetta and Placebo treatment groups.||||0.2780
72525536|NCT01868594|144581496|SUPERIORITY|||||||0.8114||||||"The p-value associated with treatment factor of changes from baseline to Week 12, 24 and 36 endpoint between Subetta and Placebo treatment groups. Model includes treatment, visit and treatment\*visit interaction."|Mixed Models Analysis|||Analysis of HDL cholesterol changes from baseline to Week 12, 24 and 36 endpoint between Subetta and Placebo treatment groups.||||0.8114
72525537|NCT01868594|144581496|SUPERIORITY|||||||0.1619||||||"The p-value associated with treatment factor of changes from baseline to Week 12, 24 and 36 endpoint between Subetta and Placebo treatment groups. Model includes treatment, visit and treatment\*visit interaction."|Mixed Models Analysis|||Analysis of LDL cholesterol changes from baseline to Week 12, 24 and 36 endpoint between Subetta and Placebo treatment groups.||||0.1619
72525538|NCT01868594|144581496|SUPERIORITY|||||||0.0764||||||"The p-value associated with treatment factor of changes from baseline to Week 12, 24 and 36 endpoint between Subetta and Placebo treatment groups. Model includes treatment, visit and treatment\*visit interaction."|Mixed Models Analysis|||Analysis of Triglycerides changes from baseline to Week 12, 24 and 36 endpoint between Subetta and Placebo treatment groups.||||0.0764
72525539|NCT01868594|144581497|SUPERIORITY|||||||0.3107||||||The p-value associated with comparison of changes from baseline to Week 36 endpoint between Subetta and Placebo treatment groups.|t-test, 2 sided|||Analysis of basal insulin changes from baseline to Week 36 endpoint between Subetta and Placebo treatment groups.||||0.3107
72525540|NCT01868594|144581497|SUPERIORITY|||||||0.5236||||||The p-value associated with comparison of changes from baseline to Week 36 endpoint between Subetta and Placebo treatment groups.|t-test, 2 sided|||Analysis of prandial insulin changes from baseline to Week 36 endpoint between Subetta and Placebo treatment groups.||||0.5236
72525541|NCT01868594|144581497|SUPERIORITY|||||||0.3847||||||The p-value associated with comparison of changes from baseline to Week 36 endpoint between Subetta and Placebo treatment groups.|t-test, 2 sided|||Analysis of total daily dose insulin changes from baseline to Week 36 endpoint between Subetta and Placebo treatment groups.||||0.3847
72525542|NCT01868594|144581498|SUPERIORITY|||||||0.6716|||||||t-test, 2 sided|||||||0.6716
72525543|NCT01868594|144581499|SUPERIORITY|||||||0.2484||||||The p-value associated with comparison of Week 36 endpoint between Subetta and Placebo treatment groups.|t-test, 2 sided|||Analysis of total Treatment Satisfaction score at Week 36 endpoint between Subetta and Placebo treatment groups.||||0.2484
72525544|NCT01868594|144581499|SUPERIORITY|||||||0.761||||||The p-value associated with comparison of Week 36 endpoint between Subetta and Placebo treatment groups.|t-test, 2 sided|||"Analysis of Perceived Hyperglycaemia question at Week 36 endpoint between Subetta and Placebo treatment groups."||||0.7610
72525545|NCT01868594|144581499|SUPERIORITY|||||||0.3714||||||The p-value associated with comparison of Week 36 endpoint between Subetta and Placebo treatment groups.|t-test, 2 sided|||"Analysis of Perceived Hypoglycemia question at Week 36 endpoint between Subetta and Placebo treatment groups."||||0.3714
72525546|NCT01201967|144581503|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.68||||0.002|TWO_SIDED|95.0|2.14|9.22|||Mixed Models Analysis|||||9.22|2.14|0.002
72525547|NCT01201967|144581504|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.05||||0.045|TWO_SIDED|95.0|-4.06|-0.05|||Mixed Models Analysis|||||-0.05|-4.06|0.045
72525548|NCT01201967|144581505|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.41||||0.55|TWO_SIDED|95.0|-0.93|1.76|||Mixed Models Analysis|||||1.76|-0.93|0.55
72525549|NCT01201967|144581506|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|11.4|||<|0.001|TWO_SIDED|95.0|5.2|24.9|||Chi-squared|||||24.9|5.20|<0.001
72525550|NCT01201967|144581507|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.63||||0.28|TWO_SIDED|95.0|-0.51|1.76|||Mixed Models Analysis|||||1.76|-0.51|0.28
72525551|NCT01201967|144581508|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.96||||0.83|TWO_SIDED|95.0|0.63|1.46|||Chi-squared|||||1.46|0.63|0.83
72525552|NCT01201967|144581509|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.11||||0.029|TWO_SIDED|95.0|0.012|0.22|||Mixed Models Analysis|||||0.22|0.012|0.029
72525553|NCT01201967|144581510|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.59||||0.005|TWO_SIDED|95.0|1.71|9.46|||Mixed Models Analysis|||||9.46|1.71|0.005
72525554|NCT01201967|144581511|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.3||||0.11|TWO_SIDED|95.0|-0.54|5.14|||Mixed Models Analysis|||||5.14|-0.54|0.11
72525555|NCT04363944|144581552|EQUIVALENCE|A paired-t test comparing performance of vertical bowl transfer at the beginning of the 6 week in-home program to the end of the 6 week in-home program.|||||<|0.001||||||Comparing the change in performing a vertical bowl transfer, the calculated p-value for this activity was \<.001|t-test, 2 sided|||mRehab task vertical bowl transfer- moving the bowl vertically up and down||||<0.001
72525556|NCT04363944|144581552|EQUIVALENCE|A paired-t test comparing performance of moving the bowl horizontally at the beginning of the 6 week in-home program to the end of the 6 week in-home program.|||||=|0.001||||||Comparing the change in performing a horizontal bowl transfer, the calculated p-value for this activity was .001|t-test, 2 sided|||mRehab task horizontal bowl transfer- moving the bowl horizontally||||=.001
72571172|NCT00667810|144670767|SUPERIORITY_OR_OTHER|||||||0.855|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.855
72571173|NCT00667810|144670767|SUPERIORITY_OR_OTHER|||||||0.423|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.423
72406668|NCT04530552|144321957|OTHER||See above|0.943|||||TWO_SIDED|||||||||Posterior probability of observing a response rate ≥ 25%||||
72406669|NCT04530552|144321958|OTHER|Two-sided paired t-test at 2.5% significance level (Bonferroni correction)||||||0.034||||||Two-sided paired t-test at 2.5% significance level (Bonferroni correction)|paired t-test|||||||0.034
72525557|NCT04363944|144581552|EQUIVALENCE|A paired-t test comparing performance of the vertical mug transfer at the beginning of the 6 week in-home program to the end of the 6 week in-home program.|||||=|0.003||||||Comparing the change in performing a vertical mug transfer, the calculated p-value for this activity was .003|t-test, 2 sided|||mRehab task vertical mug transfer- moving the mug vertically up and down||||=.003
72525558|NCT04363944|144581552|EQUIVALENCE|A paired-t test comparing performance of the horizontal mug transfer at the beginning of the 6 week in-home program to the end of the 6 week in-home program.|||||=|0.009||||||Comparing the change in performing a horizontal mug transfer, the calculated p-value for this activity was .009|t-test, 2 sided|||mRehab task horizontal mug transfer- moving the mug horizontally||||=.009
72525559|NCT04363944|144581552|EQUIVALENCE|A paired-t test comparing performance of the simulated sip at the beginning of the 6 week in-home program to the end of the 6 week in-home program.|||||=|0.933|||||||t-test, 2 sided|A paired-t test comparing performance at the beginning of the 6 week in-home program to the end of the 6 week in-home program.||mRehab task simulate sip- bring mug within one inch of mouth as if taking a drink||||=.933
72525560|NCT04363944|144581552|EQUIVALENCE|A paired-t test comparing performance of entering a phone number at the beginning of the 6 week in-home program to the end of the 6 week in-home program.|||||=|0.136|||||||t-test, 2 sided|||mRehab task enter phone number||||=.136
72525561|NCT04363944|144581552|EQUIVALENCE|A paired-t test comparing performance of the quick tap at the beginning of the 6 week in-home program to the end of the 6 week in-home program.|||||=|0.005|||||||t-test, 2 sided|||mRehab task quick tap- tapping a moving object on the phone screen||||=.005
72525562|NCT04363944|144581553|EQUIVALENCE|Paired t-tests comparing performance at the first session of in-home training to the last session of in-home training were conducted.|||||=|0.228|||||||t-test, 2 sided|||mRehab task vertical bowl transfer- moving bowl vertically up and down||||=.228
72525563|NCT04363944|144581553|EQUIVALENCE|A paired-t test comparing performance at the beginning of the 6 week in-home program to the end of the 6 week in-home program.||||||0.196|||||||t-test, 2 sided|||mRehab task horizontal bowl- bowl moved horizontally||||.196
72525564|NCT04363944|144581553|EQUIVALENCE|A paired-t test comparing performance at the beginning of the 6 week in-home program to the end of the 6 week in-home program.|||||=|0.024|||||||t-test, 2 sided|||mRehab task Vertical Mug- Mug moved vertically and then placed on counter||||=.024
72525565|NCT04363944|144581553|EQUIVALENCE|A paired-t test comparing performance at the beginning of the 6 week in-home program to the end of the 6 week in-home program.|||||=|0.038|||||||t-test, 2 sided|||mRehab task horizontal mug transfer- moving the mug horizontally||||=.038
72525566|NCT04363944|144581553|EQUIVALENCE|A paired-t test comparing performance at the beginning of the 6 week in-home program to the end of the 6 week in-home program.|||||=|0.306||||||calculated p-value greater than .05|t-test, 2 sided|||mRehab task simulate sip||||=.306
72525567|NCT04363944|144581554|EQUIVALENCE|The average of the WMFT from testing sessions pre intervention (week 1 and approximately week 2) was compared to the WMFT immediately following mRehab home intervention (week 8) using a two tailed paired t-test.|||||=|0.017||||||calculated p-value .017|t-test, 2 sided|||||||=.017
72525568|NCT04363944|144581555|EQUIVALENCE|Test, the scores from the first and second in-laboratory visits were averaged to account for variability in the performance of individuals with stroke. This averaged preintervention score was compared with the third in-laboratory visit to assess the immediate change in performance following use of mRehab.|||||=|0.019|||||||t-test, 2 sided|||Compared pre and post intervention data for participants using mRehab for a 6 week home program.||||=.019
72525569|NCT01693562|144581592|EQUIVALENCE|Other||||||0.016|||||||Regression, Cox|||||||0.016
72525570|NCT01693562|144581593|EQUIVALENCE|Other||||||0.0046|||||||Regression, Cox|||||||0.0046
72525571|NCT05618808|144581612|SUPERIORITY||Posterior Odds Ratio|0.78|||||TWO_SIDED|90.0|0.47|1.32|||||REGN9933 vs Enoxaparin||"Bayesian Logistic Regression; Confidence Interval refers to Credible Interval"|1.32|0.47|
72525572|NCT05618808|144581615|SUPERIORITY||Posterior Odds Ratio|0.44|||||TWO_SIDED|90.0|0.16|1.61|||||REGN9933 vs Enoxaparin||"Bayesian Logistic Regression; Confidence Interval refers to Credible Interval"|1.61|0.16|
72525573|NCT05618808|144581616|SUPERIORITY||Posterior Odds Ratio|0.79|||||TWO_SIDED|90.0|0.47|1.32|||||REGN9933 vs Enoxaparin||"Bayesian Logistic Regression; Confidence Interval refers to Credible Interval"|1.32|0.47|
72406670|NCT04530552|144321958|OTHER|||||||0.252||||||Two-sided paired t-test at 2.5% significance level (Bonferroni correction)|paired t-test|||||||0.252
72525574|NCT05618808|144581622|SUPERIORITY||Posterior Odds Ratio|0.54|||||TWO_SIDED|90.0|0.32|0.95|||||Enoxaparin vs Apixaban||"Bayesian Logistic Regression; Confidence Interval refers to Credible Interval"|0.95|0.32|
72525575|NCT05085275|144581639|NON_INFERIORITY|The study planned to enroll 400 patients (200 patients in each treatment arm) to achieve 90% power to detect a hazard ratio (HR) of 0.60 for the primary composite endpoint, with differences between treatment groups assessed using a 2-sided alpha of \<0.05|Hazard Ratio (HR)|0.73||||0.1602|TWO_SIDED|95.0|0.46|1.14|||Regression, Cox|||||1.14|0.46|.1602
72525576|NCT05085275|144581641|OTHER||Hazard Ratio (HR)|0.78|STANDARD_ERROR_OF_MEAN|0.2392||0.3|||||||Regression, Cox|||||||.30
72525577|NCT05085275|144581642|OTHER||Hazard Ratio (HR)|0.35|STANDARD_ERROR_OF_MEAN|0.8295||0.17|||||||Regression, Cox|||||||0.17
72525578|NCT01327573|144581693|SUPERIORITY_OR_OTHER|||||||0.09||||||"This p-value was for the overall slope difference between groups (i.e. the interaction between group and time).~Significance level was set at 0.1 a priori."|Mixed effects model analysis|||Analysis used eGFR, group, time, and group-by-time variables.||||0.09
72571174|NCT00667810|144670768|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.16||||0.516|TWO_SIDED|95.0|-0.65|0.33|||Mixed Models Analysis|||Change in DS score was analyzed using a REML based MMRM.||0.33|-0.65|0.516
72571175|NCT00667810|144670768|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.29||||0.257|TWO_SIDED|95.0|-0.79|0.21|||Mixed Models Analysis|||Change in DS score was analyzed using a REML based MMRM.||0.21|-0.79|0.257
72571176|NCT00667810|144670769|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.36||||0.238|TWO_SIDED|95.0|-0.96|0.24|||Mixed Models Analysis|||Change in CDR-SOB total score was analyzed using a REML based MMRM.||0.24|-0.96|0.238
72571177|NCT00667810|144670769|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.18||||0.564|TWO_SIDED|95.0|-0.78|0.43|||Mixed Models Analysis|||Change in CDR-SOB total score was analyzed using a REML based MMRM.||0.43|-0.78|0.564
72571178|NCT00505375|144670776|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0014|||||||ANCOVA|||"The calculation for the concentration of c-peptide is a weighted average of the 6 timed measurements of c-peptide in nano-moles/Liter. We try to distinguish this calculation from the AUC by referring to it as the AUC mean and may be expressed algebraically as the AUC/(120 min.); thus, the units are the same as the y-axis."||||0.0014
72571179|NCT03709823|144670777|SUPERIORITY||LS Mean Difference vs. Placebo|-20.48||||0.0002|TWO_SIDED|95.0|-31.141|-9.821||Based on analysis of variance models with percent of expected cigarettes smoked as the dependent variable, treatment and body mass index class as main fixed effects, with covariate of baseline cigarettes.|ANOVA|||||-9.821|-31.141|0.0002
72625263|NCT01098747|144780084|SUPERIORITY_OR_OTHER||Difference in proportion|24.36|||<|0.001|TWO_SIDED|95.0|13.51|35.22||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||0.5 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||35.22|13.51|<0.001
72625264|NCT01098747|144780084|SUPERIORITY_OR_OTHER||Difference in proportion|11.82||||0.023|TWO_SIDED|95.0|1.15|22.48||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||0.5 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||22.48|1.15|0.023
72525579|NCT03070119|144581706|SUPERIORITY||Least square (LS) geometric mean ratio|0.86|||||TWO_SIDED|95.0|0.69|1.08||||||Week 52 - The analysis was based on an analysis of covariance (ANCOVA) model with natural log transformed data. The model included covariates for the corresponding baseline value i.e. log value, and use of riluzole or edaravone. Multiple imputation (MI) including treatment group, use of riluzole or edaravone, and the relevant baseline and postbaseline values for the endpoint was used for missing data.||1.08|0.69|
72525580|NCT03070119|144581706|SUPERIORITY||LS geometric mean ratio|0.91|||=|0.3711|TWO_SIDED|95.0|0.75|1.11|||ANCOVA|ANCOVA model using MI.||Week 104 - The analysis was based on an ANCOVA model with natural log transformed data. The model included covariates for the corresponding baseline value i.e. log value, and use of riluzole or edaravone. Multiple imputation including treatment group, use of riluzole or edaravone, and the relevant baseline and postbaseline values for the endpoint was used for missing data.||1.11|0.75|=0.3711
72525581|NCT03070119|144581706|SUPERIORITY||LS geometric mean ratio|1.06|||=|0.6344|TWO_SIDED|95.0|0.84|1.34|||ANCOVA|ANCOVA model using MI.||Week 148 - The analysis was based on an ANCOVA model with natural log transformed data. The model included covariates for the corresponding baseline value i.e. log value, and use of riluzole or edaravone. Multiple imputation including treatment group, use of riluzole or edaravone, and the relevant baseline and postbaseline values for the endpoint was used for missing data.||1.34|0.84|=0.6344
72525582|NCT03070119|144581707|SUPERIORITY||LS geometric mean ratio|0.8|||||TWO_SIDED|95.0|0.63|1.03||||||Week 52 - The analysis was based on an ANCOVA model with natural log transformed data. The model included covariates for the corresponding baseline value i.e. log value, and use of riluzole or edaravone. Multiple imputation including treatment group, use of riluzole or edaravone, and the relevant baseline and postbaseline values for the endpoint was used for missing data.||1.03|0.63|
72525583|NCT03070119|144581707|SUPERIORITY||LS geometric mean ratio|0.83|||=|0.2306|TWO_SIDED|95.0|0.6|1.13|||ANCOVA|ANCOVA model using MI.||Week 104 - The analysis was based on an ANCOVA model with natural log transformed data. The model included covariates for the corresponding baseline value i.e. log value, and use of riluzole or edaravone. Multiple imputation including treatment group, use of riluzole or edaravone, and the relevant baseline and postbaseline values for the endpoint was used for missing data.||1.13|0.60|=0.2306
72525584|NCT03070119|144581707|SUPERIORITY||LS geometric mean ratio|0.92|||=|0.673|TWO_SIDED|95.0|0.61|1.38|||ANCOVA|ANCOVA model using MI.||Week 148 - The analysis was based on an ANCOVA model with natural log transformed data. The model included covariates for the corresponding baseline value i.e. log value, and use of riluzole or edaravone. Multiple imputation including treatment group, use of riluzole or edaravone, and the relevant baseline and postbaseline values for the endpoint was used for missing data.||1.38|0.61|=0.6730
72525585|NCT03070119|144581708|SUPERIORITY||Least square (LS) mean difference|3.6|STANDARD_ERROR_OF_MEAN|1.58|||TWO_SIDED|95.0|0.5|6.7||||||Week 52 - The analysis was based on an ANCOVA model that included treatment as a fixed effect and adjusted for the following covariates: baseline plasma NfL, baseline ALSFRS-R total score, and use of riluzole or edaravone. Multiple imputation including treatment group, use of riluzole or edaravone, baseline NfL, and the relevant baseline and postbaseline values for the endpoint was used for missing data.||6.7|0.5|
72571180|NCT03709823|144670777|SUPERIORITY||LS Mean Difference vs. Placebo|-22.07|||<|0.0001|TWO_SIDED|95.0|-32.791|-11.342||Based on analysis of variance models with percent of expected cigarettes smoked as the dependent variable, treatment and body mass index class as main fixed effects, with covariate of baseline cigarettes.|ANOVA|||||-11.342|-32.791|< 0.0001
72571181|NCT03709823|144670777|SUPERIORITY||LS Mean Difference vs. Placebo|-5.9||||0.2708|TWO_SIDED|95.0|-16.463|4.66||Based on analysis of variance models with percent of expected cigarettes smoked as the dependent variable, treatment and body mass index class as main fixed effects, with covariate of baseline cigarettes.|ANOVA|||||4.660|-16.463|0.2708
72571182|NCT03709823|144670777|SUPERIORITY||LS Mean Difference vs. Placebo|-2.81||||0.6018|TWO_SIDED|95.0|-13.438|7.82||Based on analysis of variance models with percent of expected cigarettes smoked as the dependent variable, treatment and body mass index class as main fixed effects, with covariate of baseline cigarettes.|ANOVA|||||7.820|-13.438|0.6018
72571183|NCT03709823|144670777|SUPERIORITY||LS Mean Difference vs. Commercial Sched.|-12.17||||0.1025|TWO_SIDED|95.0|-26.869|2.535||Based on analysis of variance models with percent of expected cigarettes smoked as the dependent variable, treatment and body mass index class as main fixed effects, with covariate of baseline cigarettes.|ANOVA|||||2.535|-26.869|0.1025
72406671|NCT04530552|144321959|OTHER|||||||1||||||Significance level of 2.5% (Bonferroni correction)|Pearson correlation|||Correlation with % change PSA at end-of-intervention||||1.0
72525586|NCT03070119|144581708|SUPERIORITY||LS mean difference|3.7|STANDARD_ERROR_OF_MEAN|2.28|=|0.1054|TWO_SIDED|95.0|-0.8|8.2|||ANCOVA|ANCOVA model using MI.||Week 104 - The analysis was based on an ANCOVA model that included treatment as a fixed effect and adjusted for the following covariates: baseline plasma NfL, baseline ALSFRS-R total score, and use of riluzole or edaravone. Multiple imputation including treatment group, use of riluzole or edaravone, baseline NfL, and the relevant baseline and postbaseline values for the endpoint was used for missing data.||8.2|-0.8|=0.1054
72525587|NCT03070119|144581708|SUPERIORITY||LS mean difference|3.6|STANDARD_ERROR_OF_MEAN|2.46|=|0.1432|TWO_SIDED|95.0|-1.2|8.4|||ANCOVA|ANCOVA model using MI.||Week 148 - The analysis was based on an ANCOVA model that included treatment as a fixed effect and adjusted for the following covariates: baseline plasma NfL, baseline ALSFRS-R total score, and use of riluzole or edaravone. Multiple imputation including treatment group, use of riluzole or edaravone, baseline NfL, and the relevant baseline and postbaseline values for the endpoint was used for missing data.||8.4|-1.2|=0.1432
72525588|NCT03070119|144581709|SUPERIORITY||LS mean difference|8.1|STANDARD_ERROR_OF_MEAN|3.99|||TWO_SIDED|95.0|0.3|15.9||||||Week 52 - The analysis was based on an ANCOVA model that included treatment as a fixed effect and adjusted for the following covariates: baseline plasma NfL, baseline percent predicted SVC and use of riluzole or edaravone. Multiple imputation including treatment group, use of riluzole or edaravone, baseline NfL, and the relevant baseline and postbaseline values for the endpoint was used for missing data.||15.9|0.3|
72571184|NCT03709823|144670778|SUPERIORITY||LS Mean Difference vs. Placebo|-14.61||||0.001|TWO_SIDED|95.0|-23.216|-6.009||Based on analysis of variance models with percent of expected cigarettes smoked as the dependent variable, treatment and body mass index class as main fixed effects, with covariate of baseline cigarettes.|ANOVA|||||-6.009|-23.216|0.0010
72571185|NCT03709823|144670778|SUPERIORITY||LS Mean Difference vs. Placebo|-16.2||||0.0003|TWO_SIDED|95.0|-24.862|-7.548||Based on analysis of variance models with percent of expected cigarettes smoked as the dependent variable, treatment and body mass index class as main fixed effects, with covariate of baseline cigarettes.|ANOVA|||||-7.548|-24.862|0.0003
72571186|NCT03709823|144670779|SUPERIORITY||LS Mean Difference vs. Placebo|-12.41||||0.0091|TWO_SIDED|95.0|-21.695|-3.135||Based on analysis of variance models with percent of expected cigarettes smoked as the dependent variable, treatment and body mass index class as main fixed effects, with covariate of baseline cigarettes.|ANOVA|||||-3.135|-21.695|0.0091
72571187|NCT03709823|144670779|SUPERIORITY||LS Mean Difference vs. Placebo|-9.3||||0.0518|TWO_SIDED|95.0|-18.667|0.075||Based on analysis of variance models with percent of expected cigarettes smoked as the dependent variable, treatment and body mass index class as main fixed effects, with covariate of baseline cigarettes.|ANOVA|||||0.075|-18.667|0.0518
72571188|NCT01175811|144670783|SUPERIORITY_OR_OTHER||LSmean difference|0.01|||||TWO_SIDED|95.0|-0.14|0.16||||||||0.16|-0.14|
72571189|NCT01175811|144670784|SUPERIORITY_OR_OTHER||LSmean Difference|0.0|||||TWO_SIDED|95.0|-0.15|0.16||||||||0.16|-0.15|
72571190|NCT01175811|144670785|SUPERIORITY_OR_OTHER|||||||0.344||95.0||||P-value is for the comparison of participants achieving \<=6.5% HbA1c at 12 weeks. P-value was not adjusted for multiplicity and should be interpreted as nominal.|Fisher Exact|||||||0.344
72571191|NCT01175811|144670785|SUPERIORITY_OR_OTHER|||||||0.822||95.0||||P-value is for the comparison of participants achieving \<=7.0% HbA1c at 12 weeks. P-value was not adjusted for multiplicity and should be interpreted as nominal.|Fisher Exact|||||||0.822
72571192|NCT01175811|144670785|SUPERIORITY_OR_OTHER|||||||0.417||95.0||||P-value is for the comparison of participants achieving \<=6.5% HbA1c at 24 weeks. P-value was not adjusted for multiplicity and should be interpreted as nominal.|Fisher Exact|||||||0.417
72571193|NCT01175811|144670785|SUPERIORITY_OR_OTHER|||||||0.392||95.0||||P-value is for the comparison of participants achieving \<=7.0% HbA1c at 24 weeks. P-value was not adjusted for multiplicity and should be interpreted as nominal.|Fisher Exact|||||||0.392
72571194|NCT01340768|144670794|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.52||||0.028|TWO_SIDED|95.0|0.29|0.94||P-value for association between treatment groups and proportions controlling for prior therapy (monotherapy or combination therapy).|Cochran-Mantel-Haenszel|||||0.94|0.29|0.028
72571195|NCT01340768|144670795|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.49||||0.006|TWO_SIDED|95.0|0.29|0.83||P-value for association between treatment groups and proportions controlling for prior therapy (monotherapy or combination therapy).|Cochran-Mantel-Haenszel|||||0.83|0.29|0.006
72571196|NCT00140426|144670801|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.85||||0.55|TWO_SIDED|95.0|0.41|1.74|||Regression, Cox|Time to reaching ease of eating level 3 assessed using Cox regression as some patients did not reach it during the study.|The hazard ratio is for the placebo group versus the treatment group. A hazard ratio \<1 implies that the placebo group had a lower risk of achieving EOE level 3, although not statistically significant. Achieving EOE level 3 was the desired endpoint.|||1.74|0.41|0.55
72571197|NCT00140426|144670805|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.38|STANDARD_DEVIATION|3.74||0.1|TWO_SIDED||||||t-test, 2 sided|||||||0.10
72571198|NCT00140426|144670805|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-43.45|STANDARD_DEVIATION|20.88|<|0.01|TWO_SIDED||||||t-test, 2 sided|||||||<0.01
72406672|NCT04530552|144321959|OTHER|||||||1||||||Significance level of 2.5% (Bonferroni correction)|Pearson correlation|||Correlation with % change PSA at end-of-intervention||||1.0
72406673|NCT04530552|144321960|OTHER|||||||0.658||||||two-sided paired t-test (no Bonferroni adjustment)|paired t-test|||||||0.658
72406674|NCT04530552|144321960|OTHER|||||||0.167||||||Two-sided paired t-test (no Bonferroni adjustment)|paired t-test|||||||0.167
72525589|NCT03070119|144581709|SUPERIORITY||LS mean difference|9.3|STANDARD_ERROR_OF_MEAN|5.6|=|0.0963|TWO_SIDED|95.0|-1.7|20.4|||ANCOVA|ANCOVA model using MI.||Week 104 - The analysis was based on an ANCOVA model that included treatment as a fixed effect and adjusted for the following covariates: baseline plasma NfL, baseline percent predicted SVC and use of riluzole or edaravone. Multiple imputation including treatment group, use of riluzole or edaravone, baseline NfL, and the relevant baseline and postbaseline values for the endpoint was used for missing data.||20.4|-1.7|=0.0963
72525590|NCT03070119|144581709|SUPERIORITY||LS mean difference|4.3|STANDARD_ERROR_OF_MEAN|5.56|=|0.4388|TWO_SIDED|95.0|-6.6|15.2|||ANCOVA|ANCOVA model using MI.||Week 148 - The analysis was based on an ANCOVA model that included treatment as a fixed effect and adjusted for the following covariates: baseline plasma NfL, baseline percent predicted SVC and use of riluzole or edaravone. Multiple imputation including treatment group, use of riluzole or edaravone, baseline NfL, and the relevant baseline and postbaseline values for the endpoint was used for missing data.||15.2|-6.6|= 0.4388
72525591|NCT03070119|144581710|SUPERIORITY||LS mean difference|0.26|STANDARD_ERROR_OF_MEAN|0.109|||TWO_SIDED|95.0|0.051|0.477||||||Week 52 - The analysis was based on an ANCOVA model that included treatment as a fixed effect and adjusted for the following covariates: baseline plasma NfL, baseline HHD overall megascore and use of riluzole or edaravone. Multiple imputation including treatment group, use of riluzole or edaravone, baseline NfL, and the relevant baseline and postbaseline values for the endpoint was used for missing data.||0.477|0.051|
72525592|NCT03070119|144581710|SUPERIORITY||LS mean difference|0.14|STANDARD_ERROR_OF_MEAN|0.145|=|0.3207|TWO_SIDED|95.0|-0.141|0.43|||ANCOVA|ANCOVA model using MI.||Week 104 - The analysis was based on an ANCOVA model that included treatment as a fixed effect and adjusted for the following covariates: baseline plasma NfL, baseline HHD overall megascore and use of riluzole or edaravone. Multiple imputation including treatment group, use of riluzole or edaravone, baseline NfL, and the relevant baseline and postbaseline values for the endpoint was used for missing data.||0.430|-0.141|=0.3207
72525593|NCT03070119|144581710|SUPERIORITY||LS mean difference|0.06|STANDARD_ERROR_OF_MEAN|0.091|=|0.5452|TWO_SIDED|95.0|-0.124|0.234|||ANCOVA|ANCOVA model using MI.||Week 148 - The analysis was based on an ANCOVA model that included treatment as a fixed effect and adjusted for the following covariates: baseline plasma NfL, baseline HHD overall megascore and use of riluzole or edaravone. Multiple imputation including treatment group, use of riluzole or edaravone, baseline NfL, and the relevant baseline and postbaseline values for the endpoint was used for missing data.||0.234|-0.124|=0.5452
72525594|NCT03070119|144581712|SUPERIORITY||Hazard Ratio (HR)|0.64|||=|0.4202|TWO_SIDED|95.0|0.282|1.461|||Log Rank|The analysis was based on a log rank test stratified by median baseline plasma NfL.|The analysis was based on a Cox proportional hazards model adjusted for baseline plasma NfL, and riluzole or edaravone use.|||1.461|0.282|=0.4202
72525595|NCT03070119|144581713|SUPERIORITY||Hazard Ratio (HR)|0.52|||=|0.3108|TWO_SIDED|95.0|0.199|1.357|||Log Rank|The analysis was based on a log rank test stratified by median baseline plasma NfL.|The analysis was based on a Cox proportional hazards model adjusted for baseline plasma NfL, and riluzole or edaravone use.|||1.357|0.199|=0.3108
72525596|NCT00732472|144581717|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.26|STANDARD_ERROR_OF_MEAN|2.777|||TWO_SIDED|95.0|-3.39|7.91|||||Day 1, Max HR|||7.91|-3.39|
72525597|NCT00732472|144581717|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.25|STANDARD_ERROR_OF_MEAN|2.922|||TWO_SIDED|95.0|-4.78|7.28|||||Day 7, Max HR|||7.28|-4.78|
72525598|NCT00732472|144581717|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.27|STANDARD_ERROR_OF_MEAN|2.772|||TWO_SIDED|95.0|-2.37|8.91|||||Day 1, Max HR|||8.91|-2.37|
72525599|NCT00732472|144581717|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.25|STANDARD_ERROR_OF_MEAN|2.729|||TWO_SIDED|95.0|-7.89|3.39|||||Day 7, Max HR|||3.39|-7.89|
72406675|NCT06034496|144321964|SUPERIORITY|||||||0.012||||||CES main effect|ANOVA|||||||.012
72525600|NCT00732472|144581717|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.49|STANDARD_ERROR_OF_MEAN|2.899|||TWO_SIDED|95.0|1.59|13.39|||||Day 1, Max HR|||13.39|1.59|
72525601|NCT00732472|144581717|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.7|STANDARD_ERROR_OF_MEAN|3.079|||TWO_SIDED|95.0|2.34|15.05|||||Day 7, Max HR|||15.05|2.34|
72525602|NCT00732472|144581717|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.23|STANDARD_ERROR_OF_MEAN|2.243|||TWO_SIDED|95.0|-4.8|4.34|||||Day 1, WM|||4.34|-4.80|
72406676|NCT06034496|144321964|SUPERIORITY|||||||0.33||||||Session main effect|ANOVA|||||||.33
72525603|NCT00732472|144581717|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.15|STANDARD_ERROR_OF_MEAN|2.52|||TWO_SIDED|95.0|-5.09|5.4|||||Day 7, WM|||5.40|-5.09|
72525604|NCT00732472|144581717|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.33|STANDARD_ERROR_OF_MEAN|2.182|||TWO_SIDED|95.0|-2.12|6.77|||||Day 1, WM|||6.77|-2.12|
72525605|NCT00732472|144581717|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.51|STANDARD_ERROR_OF_MEAN|2.378|||TWO_SIDED|95.0|-7.48|2.45|||||Day 7, WM|||2.45|-7.48|
72525606|NCT00732472|144581717|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.16|STANDARD_ERROR_OF_MEAN|2.282|||TWO_SIDED|95.0|1.51|10.81|||||Day 1, WM|||10.81|1.51|
72525607|NCT00732472|144581717|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.06|STANDARD_ERROR_OF_MEAN|2.642|||TWO_SIDED|95.0|1.57|12.54|||||Day 7, WM|||12.54|1.57|
72525608|NCT01058395|144581739|SUPERIORITY|"Comparison between groups at 3 months (primary).~Comparison between the 2 tiers."||||||0.021||||||P-value|ANCOVA|Threshold for significance was P-value \< 0.05||DRS levels changes at from 4 weeks to 3 months comparing the different doses.||||0.021
72525609|NCT01058395|144581739|SUPERIORITY|||||||0.258|||||||t-test, 2 sided|||Null hypothesis is that there is no difference between groups in the DRS scores at 3 months.||||0.258
72525610|NCT01058395|144581739|SUPERIORITY|t-test||||||0.541|||||||t-test, 2 sided|||Null hypothesis is that there is no difference between groups in the DRS scores at 4 weeks.||||0.541
72406677|NCT06034496|144321964|SUPERIORITY|||||||0.85||||||Session (baseline, follow-up) x CES|ANOVA|||||||.85
72406678|NCT06034496|144321965|SUPERIORITY|||||||0.6||||||CES main effect|ANOVA|||||||.6
72406679|NCT06034496|144321965|SUPERIORITY|||||||0.9||||||Session main effect|ANOVA|||||||.9
72406680|NCT06034496|144321965|SUPERIORITY|||||||0.05||||||CES x Session interaction|ANOVA|||||||.05
72406681|NCT06034496|144321966|SUPERIORITY|||||||0.26||||||CES main effect|ANOVA|||||||.26
72406682|NCT06034496|144321966|SUPERIORITY|||||||0.17||||||Session main effect|ANOVA|||||||.17
72625265|NCT01098747|144780084|SUPERIORITY_OR_OTHER||Difference in proportion|61.35|||<|0.001|TWO_SIDED|95.0|48.99|73.7||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1 hour: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||73.70|48.99|<0.001
72525611|NCT01058395|144581741|SUPERIORITY||Mean Difference (Final Values)|176.0|||>|0.05|ONE_SIDED||||||t-test, 2 sided|||||||>0.05
72525612|NCT01266876|144581742|SUPERIORITY_OR_OTHER|||||||0|TWO_SIDED|||||Threshold for significance at ≤ 0.05.|ANCOVA|||"Each treatment group was compared to placebo using ANCOVA-derived contrasts.~A hierarchical testing procedure was applied to ensure strong control of overall Type-I error rate at 0.05 level. Order was following:~1. Alirocumab 150 mg Q2W versus placebo~2. Alirocumab 300 mg Q4W versus placebo~3. Alirocumab 200 mg Q4W versus placebo~4. Alirocumab 150 mg Q4W versus placebo~Testing continued only when high-order test was statistically significant at 5% level."||||0.0000
72525613|NCT01266876|144581742|SUPERIORITY_OR_OTHER|||||||0|TWO_SIDED|||||Threshold for significance at ≤ 0.05.|ANCOVA|||||||0.0000
72525614|NCT01266876|144581742|SUPERIORITY_OR_OTHER|||||||0.0035|TWO_SIDED|||||Threshold for significance at ≤ 0.05.|ANCOVA|||||||0.0035
72525615|NCT01266876|144581742|SUPERIORITY_OR_OTHER|||||||0.0113|TWO_SIDED|||||Threshold for significance at ≤ 0.05.|ANCOVA|||||||0.0113
72525616|NCT04083781|144581761|SUPERIORITY|Analyses of count endpoints were analysed using a negative binomial regression model with the logarithm of the length of the observation period included (in years) as an offset with randomised treatment regimen, type of haemophilia (HAwI or HBwI) and bleeding frequency (less than 9 or greater than or equal to 9 bleeding episodes during the past 24 weeks prior to screening) as factors comparing arm 1 (on-demand treatment) and arm 2.|Annualised bleeding rate ratio|0.14|||<|0.001|TWO_SIDED|95.0|0.07|0.29|||Two-sided test of no difference from 1|||||0.29|0.07|<0.001
72525617|NCT00557362|144581815|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.098||||0.29|TWO_SIDED|95.0|-0.28|0.083|||Regression, Linear|Multiple linear regression model adjusted for enrollment BSCVA and corneal de-epithelialization||||0.083|-0.28|0.29
72525618|NCT00557362|144581816|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.23||||0.4|TWO_SIDED|95.0|0.76|2.02|||Regression, Cox|||||2.02|0.76|0.40
72525619|NCT00557362|144581817|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.17||||0.37|TWO_SIDED|95.0|-0.2|0.53|||Regression, Linear|||||0.53|-0.20|0.37
72525620|NCT00557362|144581818|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.08||||0.62|TWO_SIDED|95.0|-0.25|0.41|||Regression, Linear|||Best spectacle-corrected visual acuity (BSCVA) was examined in a linear regression model with enrollment BSCVA and treatment arm as covariates among a subgroup of ulcers caused by Fusarium spp.||0.41|-0.25|0.62
72525621|NCT00557362|144581818|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.2||||0.26|TWO_SIDED|95.0|-0.57|0.17|||Regression, Linear|||Best spectacle-corrected visual acuity (BSCVA) was evaluated in a linear regression model with enrollment BSCVA and treatment arm as covariates in a subgroup of ulcers caused by Aspergillus spp.||0.17|-0.57|0.26
72525622|NCT00557362|144581819|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.06||||0.53|TWO_SIDED|95.0|-0.26|0.14|||Regression, Linear|||||0.14|-0.26|0.53
72525623|NCT06408818|144581844|EQUIVALENCE|To examine intervention effects on primary outcomes at posttest, we used linear regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect.|Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.06||0.69|TWO_SIDED||||||Regression, Linear|||||||0.69
72625266|NCT01098747|144780084|SUPERIORITY_OR_OTHER||Difference in proportion|21.25|||<|0.001|TWO_SIDED|95.0|9.58|32.92||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1 hour: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||32.92|9.58|<0.001
72525624|NCT06408818|144581845|EQUIVALENCE|To examine intervention effects on primary outcomes at posttest, we used linear regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect.|Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.05||0.33|TWO_SIDED||||||Regression, Linear|||||||0.33
72525625|NCT06408818|144581846|EQUIVALENCE|To examine intervention effects on primary outcomes at posttest, we used linear regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect.|Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.07||0.46|TWO_SIDED||||||Regression, Linear|||||||0.46
72525626|NCT06408818|144581847|EQUIVALENCE|To examine intervention effects on primary outcomes at posttest, we used linear regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect.|Mean Difference (Final Values)|-0.04|STANDARD_ERROR_OF_MEAN|0.06||0.46|TWO_SIDED||||||Regression, Linear|||||||0.46
72525627|NCT06408818|144581848|EQUIVALENCE|To examine intervention effects on primary outcomes at posttest, we used linear regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect.|Mean Difference (Final Values)|-0.22|STANDARD_ERROR_OF_MEAN|0.17||0.2|TWO_SIDED||||||Regression, Linear|||||||0.20
72525628|NCT06408818|144581849|EQUIVALENCE|To examine intervention effects on primary outcomes at posttest, we used linear regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect.|Mean Difference (Final Values)|0.13|STANDARD_ERROR_OF_MEAN|0.11||0.22|TWO_SIDED||||||Regression, Linear|||||||0.22
72525629|NCT06408818|144581850|EQUIVALENCE|To examine intervention effects on primary outcomes at posttest, we used linear regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect.|Mean Difference (Final Values)|0.13|STANDARD_ERROR_OF_MEAN|0.19||0.48|TWO_SIDED||||||Regression, Linear|||||||0.48
72525630|NCT06408818|144581851|EQUIVALENCE|To examine intervention effects on primary outcomes at posttest, we used linear regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect.|Mean Difference (Final Values)|0.06|STANDARD_ERROR_OF_MEAN|0.16||0.69|TWO_SIDED||||||Regression, Linear|||||||0.69
72525631|NCT06408818|144581852|EQUIVALENCE|To examine intervention effects on primary outcomes at posttest, we used logistic regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect.|Mean Difference (Final Values)|-0.78|STANDARD_ERROR_OF_MEAN|0.63||0.22|TWO_SIDED||||||Regression, Logistic|||||||0.22
72525632|NCT06408818|144581853|EQUIVALENCE|To examine intervention effects on primary outcomes at posttest, we used logistic regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect.|Slope|-0.45|STANDARD_ERROR_OF_MEAN|0.79||0.57|TWO_SIDED||||||Regression, Logistic|||||||0.57
72525633|NCT06408818|144581854|EQUIVALENCE|To examine intervention effects on primary outcomes at posttest, we used linear regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect.|Mean Difference (Final Values)|0.08|STANDARD_ERROR_OF_MEAN|0.1||0.42|TWO_SIDED||||||Regression, Linear|||||||0.42
72525634|NCT06408818|144581855|EQUIVALENCE|To examine intervention effects on primary outcomes at posttest, we used linear regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect.|Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.13||0.45|TWO_SIDED||||||Regression, Linear|||||||0.45
72525635|NCT06408818|144581856|EQUIVALENCE|To examine intervention effects on primary outcomes at posttest, we used linear regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect.|Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.12||0.39|TWO_SIDED||||||Regression, Linear|||||||0.39
72525636|NCT05492877|144581877|SUPERIORITY||Hazard Ratio (HR)|1.071||||0.599|TWO_SIDED|90.0|0.869|1.32|||Regression, Cox||||The p-value was based on a 2-sided log rank test stratified by region|1.320|0.869|0.599
72406683|NCT06034496|144321966|SUPERIORITY|||||||0.73||||||CES x Session main effect|ANOVA|||||||.73
72525637|NCT05492877|144581880|SUPERIORITY||Hazard Ratio (HR)|1.234|||||TWO_SIDED|90.0|0.882|1.726|||Regression, Cox|||||1.726|0.882|
72525638|NCT02268942|144581971|OTHER|||||||0.0003|||||||Exact Binomial|||"Success at six months is estimated to be 86% compared to a performance goal of 77.5%. Using an exact binomial test, with a one-sided alpha of 0.05, and 80% Power, a sample size of 145 implanted subjects was planned.~Success will be met if the lower bound of the upper one-sided exact 95% confidence interval is greater than 77.5%."||||0.0003
72525639|NCT02268942|144581972|OTHER||||||<|0.0001|||||||t-test, 1 sided|||"The secondary endpoint is an improvement in the mean length of initial hospital stay (initial recovery and step down unit), which is calculated by considering the number of days in acute care (ICU/CCU) plus the number of days in intermediate/step-down care, comprising the total number of days post-implant to discharge.~This secondary endpoint will be calculated using an upper tail one-sided t-test at 0.05 level of significance compared to 26.1 days for median sternotomy patients."||||<0.0001
72525640|NCT03299166|144581986|SUPERIORITY||LS Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.81||0.2202|TWO_SIDED|95.0|-2.59|0.6|||Mixed Models Analysis|||Model-based summary statistics are from a mixed model with repeated measures, including fixed effects for treatment, visit, treatment-by-visit interaction, baseline score, baseline score-by-visit interaction as covariates, and participant as random effect.||0.60|-2.59|0.2202
72525641|NCT03299166|144581993|SUPERIORITY||LS Mean Difference|-0.46|STANDARD_ERROR_OF_MEAN|0.61||0.4508|TWO_SIDED|95.0|-1.67|0.75|||Mixed Models Analysis|||"Week 4 Analysis.~Model-based summary statistics are from a mixed model with repeated measures, including fixed effects for treatment, visit, treatment-by-visit interaction, baseline score, baseline score-by-visit interaction as covariates, and participant as random effect."||0.75|-1.67|0.4508
72525642|NCT03299166|144581993|SUPERIORITY||LS Mean Difference|-1.54|STANDARD_ERROR_OF_MEAN|0.75||0.041|TWO_SIDED|95.0|-3.02|-0.06|||Mixed Models Analysis|||"Week 8 Analysis.~Model-based summary statistics are from a mixed model with repeated measures, including fixed effects for treatment, visit, treatment-by-visit interaction, baseline score, baseline score-by-visit interaction as covariates, and participant as random effect."||-0.06|-3.02|0.0410
72525643|NCT00572728|144582006|SUPERIORITY_OR_OTHER||AUC|0.68|STANDARD_ERROR_OF_MEAN|0.1||0.046|ONE_SIDED|95.0||0.83||The Delong method was used to test if the observed AUC was significantly different than 0.5 with the one-sided p value DeLong ER, DeLong DM, Clarke-Pearson DL, Biometrics (1988)|Delong method|one-sided p-value|"percent change in SUVmax was computed as: %ΔSUVmax = 100\*(FLT1-FLT2)/FLT1 a 90% 2-sided confidence interval was constructed from 2000 Bootstrapping estimates from which the 1-sided 95% CI was derived.~Hanley SE(AUC) reported."|"A receiver operating characteristic (ROC) analysis was performed to assess the significance of the Area Under the Curve (AUC) under the Null Hypothesis with a one sided alpha=0.05 (95% one-sided CL):~H0: AUC = 0.50 (no difference from guessing) given the alternative hypothesis: Ha:AUC \>= 0.75 AUC = ROC(%ΔSUVmax\| path response) where percent change (%ΔSUVmax ) was defined as (SUVmax at FLT1 -SUVmax at FLT2)/SUVmax at FLT1 x 100"||.83||0.046
72406684|NCT06034496|144321967|SUPERIORITY|||||||0.18||||||CES main effect|ANOVA|||||||.18
72525644|NCT00572728|144582007|SUPERIORITY_OR_OTHER||spearman correlation|0.35||||0.002|TWO_SIDED|95.0|0.13|0.54|||spearman correlation method||This estimate uses the Fisher's z Transformation to adjust for bias in the Spearman Correlation Statistic|H0: ρ = 0; that is, there is no correlation between SUVmax @ FLT-1 and Ki-67 LI a Fisher's z Transformation was applied to adjust for bias in the Spearman Correlation Statistic||0.54|0.13|0.002
72525645|NCT00572728|144582008|SUPERIORITY_OR_OTHER||Spearman Correlation|0.67|||<|0.0001|TWO_SIDED|95.0|0.47|0.81|||Spearman Correlation method|we use Fisher's z Transformation to adjust for bias in the Spearman Correlation Statistic|this estimate uses the Fisher's z Transformation to adjust for bias in the Spearman Correlation Statistic|H0: ρ = 0; that is, there is no correlation between SUVmax @ FLT-3 and Ki-67 LI||0.81|0.47|<0.0001
72406685|NCT06034496|144321967|SUPERIORITY|||||||0||||||Time main effect|ANOVA|||||||.00
72406686|NCT06034496|144321967|SUPERIORITY|||||||0.53||||||CES main effect|ANOVA|||||||.53
72406687|NCT06034496|144321967|SUPERIORITY|||||||0.07||||||CES x Time interaction|ANOVA|||||||.07
72406688|NCT06034496|144321967|SUPERIORITY|||||||0.46||||||CES x Session|ANOVA|||||||.46
72406689|NCT06034496|144321967|SUPERIORITY|||||||0.01||||||Time x Session interaction|ANOVA|||||||.01
72406690|NCT06034496|144321967|SUPERIORITY|||||||0.29||||||CES x Time x Session interaction|ANOVA|||||||.29
72406691|NCT06034496|144321968|SUPERIORITY|||||||0.1||||||CES main effect|ANOVA|||||||.10
72406692|NCT06034496|144321968|SUPERIORITY|||||||0||||||Time main effect|ANOVA|||||||.00
72406693|NCT06034496|144321968|SUPERIORITY|||||||0.81||||||Session main effect|ANOVA|||||||.81
72406694|NCT06034496|144321968|SUPERIORITY|||||||0.4||||||CES x Time interaction|ANOVA|||||||.40
72406695|NCT06034496|144321968|SUPERIORITY|||||||0.35||||||CES x Session interaction|ANOVA|||||||.35
72406696|NCT06034496|144321968|SUPERIORITY|||||||0||||||Time x Session interaction|ANOVA|||||||.00
72406697|NCT06034496|144321968|SUPERIORITY|||||||0.4||||||CES x Time x Session interaction|ANOVA|||||||.40
72525646|NCT00572728|144582009|SUPERIORITY_OR_OTHER|||||||0.66|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|two-sided exact p value from Wilcoxon two-sample test||"H0: Mean SUVmax (RCB 0,I) = Mean SUVmax (RCB II,III) After dichotomization, Wilcoxon two-sample test was used to compare uptake values between RCB groups.~In other words, we are comparing the means (of SUVmax) @ FLT1 between the RCB 0,I and the RCB II,III groups.."||||0.66
72406698|NCT06034496|144321969|SUPERIORITY|||||||0.23||||||STAI-T CES main effect|ANOVA|||||||.23
72406699|NCT06034496|144321969|SUPERIORITY|||||||0.45||||||STAI-T Session main effect|ANOVA|||||||.45
72525647|NCT00572728|144582010|SUPERIORITY_OR_OTHER|||||||0.86|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|\*two-sided exact p value from Wilcoxon two-sample test||H0: SUVmax (RCB 0,I) = SUVmax (RCB II,III) in other words, we are comparing the SUVmax @ FLT2 between the RCB 0,I and the RCB II,III groups.||||0.86
72406700|NCT06034496|144321969|SUPERIORITY|||||||0.38||||||STAI-T CES x Session interaction|ANOVA|||||||.38
72525648|NCT00572728|144582011|SUPERIORITY_OR_OTHER|||||||0.01|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|two-sided exact p value from Wilcoxon two-sample test||H0: SUVmax (RCB 0,I) = SUVmax (RCB II,III) in other words, we are comparing the SUVmax @ FLT3 between the RCB 0,I and the RCB II,III groups.||||0.010
72525649|NCT00572728|144582011|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.86||||0.013|TWO_SIDED|95.0|0.76|0.97|||Regression, Logistic|||H0: %SUVmax FLT1-FLT3 (RCB 0,I) = %SUVmax FLT1-FLT3 (RCB II,III) A logistic regression model is used to determine if a larger percent change in SUVmax is associated with (RCB 0,I); the null hypothesis assumes that there is no association.||0.97|0.76|0.013
72525650|NCT00572728|144582012|SUPERIORITY_OR_OTHER||AUC|0.83|||<|0.001|TWO_SIDED|90.0|0.72|0.94||Delong 1-sided p-value (alpha=0.05)|Delong Method|The Delong-Delong Clark-Pearson method using modified U-statistics was used to evaluate the AUC||"ROC analysis was used to compute the AUC and evaluate if %ΔSUVmax FLT1-FLT3 is predictive of pCR with alpha=0.05.~The Null Hypothesis assumes that the P(%ΔSUVmax FLT1-FLT3\|pCR)= 1 - P(%ΔSUVmax FLT1-FLT3\|non-pCR) that is: H0: AUC =0.5 (guessing)"||.94|.72|<0.001
72406701|NCT06034496|144321969|SUPERIORITY|||||||0.4||||||STAI-S CES main effect|ANOVA|||||||.40
72406702|NCT06034496|144321969|SUPERIORITY|||||||0||||||STAI-S Time main effect|ANOVA|||||||.00
72406703|NCT06034496|144321969|SUPERIORITY|||||||0||||||STAI-S Session main effect|ANOVA|||||||.00
72406704|NCT06034496|144321969|SUPERIORITY|||||||0.2||||||STAI-S CES x Time interaction|ANOVA|||||||.20
72406705|NCT06034496|144321969|SUPERIORITY|||||||0.39||||||STAI-S CES x Session interaction|ANOVA|||||||.39
72406706|NCT06034496|144321969|SUPERIORITY|||||||0||||||STAI-S Session x Time interaction|ANOVA|||||||.00
72406707|NCT06034496|144321969|SUPERIORITY|||||||0.38||||||STAI-S CES x Time x Session interaction|ANOVA|||||||.38
72406708|NCT06034496|144321970|SUPERIORITY|||||||0.85||||||CES main effect|ANOVA|||||||.85
72406709|NCT06034496|144321970|SUPERIORITY|||||||0.69||||||Session main effect|ANOVA|||||||.69
72406710|NCT06034496|144321970|SUPERIORITY|||||||0.4||||||CES x Session interaction|ANOVA|||||||.4
72406711|NCT06034496|144321971|SUPERIORITY|||||||0.13||||||CES main effect|ANOVA|||||||.13
72406712|NCT06034496|144321971|SUPERIORITY|||||||0.26||||||Session main effect|ANOVA|||||||.26
72406713|NCT06034496|144321971|SUPERIORITY|||||||0.44||||||CES x Session interaction|ANOVA|||||||.44
72406714|NCT06034496|144321972|SUPERIORITY|||||||0.36||||||CES main effect|ANOVA|||||||.36
72406715|NCT06034496|144321972|SUPERIORITY|||||||0||||||Session main effect|ANOVA|||||||.00
72406716|NCT06034496|144321972|SUPERIORITY|||||||0.96||||||CES x Session interaction|ANOVA|||||||.96
72406717|NCT03277261|144321976|SUPERIORITY||Rate Ratio (Ublituximab/Teriflunomide)|0.406|||<|0.0001|TWO_SIDED|95.0|0.268|0.615||GEE (Generalized Estimating Equation) model for the relapse count per participant with logarithmic link function, treatment, region, and baseline Expanded Disability Status Scale (EDSS) strata as covariates and log (years of treatment) as offset.|Negative Binomial Model|||||0.615|0.268|<0.0001
72406718|NCT03277261|144321977|SUPERIORITY||Rate Ratio (Ublituximab/Teriflunomide)|0.033|||<|0.0001|TWO_SIDED|95.0|0.019|0.058||GEE model for the relapse count per participant with logarithmic link function, treatment, region, and baseline EDSS strata as covariates and log (years of treatment) as offset.|Negative Binomial Model|||||0.058|0.019|<0.0001
72406719|NCT03277261|144321978|SUPERIORITY||Rate Ratio (Ublituximab/Teriflunomide)|0.076|||<|0.0001|TWO_SIDED|95.0|0.056|0.104||GEE model for the relapse count per participant with logarithmic link function, treatment, region, and baseline EDSS strata as covariates and log (years of treatment) as offset.|Negative Binomial Model|||||0.104|0.056|<0.0001
72406720|NCT03277261|144321980|SUPERIORITY||Odds Ratio (Ublituximab/Teriflunomide)|5.442|||<|0.0001|TWO_SIDED|95.0|3.536|8.375||Logistic regression model with treatment, region, baseline EDSS strata and log transformed baseline MRI lesion counts (T1 unenhancing, T2, Gd enhancing) as covariates.|Regression, Logistic|||||8.375|3.536|<0.0001
72406721|NCT03277261|144321981|SUPERIORITY||Odds Ratio (Ublituximab/Teriflunomide)|0.872|||=|0.4669|TWO_SIDED|95.0|0.603|1.261||Logistic regression model with treatment, region, baseline EDSS strata, and log-transformed baseline MRI counts (T1 unenhancing, T2, Gd enhancing) as covariates.|Logistic Regression|||||1.261|0.603|=0.4669
72525651|NCT00572728|144582013|SUPERIORITY_OR_OTHER|||||||0.86|TWO_SIDED||||||Kruskal-Wallis|two-sided p value from Kruskal-Wallis one-way ANOVA||"Kruskal-Wallis one-way ANOVA was used to test whether there was a difference in %SUVmax (FLT1-FLT2) among LN statuses.~H0: no difference between the 3 LN status."||||0.86
72525652|NCT00572728|144582014|SUPERIORITY_OR_OTHER|||||||0.67|TWO_SIDED|||||two-sided p value from Kruskal-Wallis one-way ANOVA|Kruskal-Wallis|||||||0.67
72406722|NCT03277261|144321982|SUPERIORITY||Least squares mean difference|-0.072|||<|0.0001|TWO_SIDED|95.0|-0.107|-0.036||The model includes treatment, region, baseline EDSS strata, visit, treatment-by-visit interaction, and baseline volume (cube root transformed) as covariates and an unstructured covariance matrix.|Mixed Model Repeated Measures (MMRM)|||||-0.036|-0.107|<0.0001
72406723|NCT05944250|144321984|SUPERIORITY|||||||0.21|||||||t-test, 2 sided|||||||0.21
72406724|NCT05944250|144321988|SUPERIORITY|||||||1|||||||t-test, 2 sided|||Wounds that reach \>50% healing from baseline per investigator assessment at Month 1||||1
72406725|NCT05944250|144321988|SUPERIORITY|||||||1|||||||t-test, 2 sided|||Wounds that reach \>50% healing from baseline per investigator assessment at Month 2||||1
72406726|NCT05944250|144321988|SUPERIORITY|||||||1|||||||t-test, 2 sided|||Wounds that reach \>50% healing from baseline per investigator assessment at Month 3||||1
72406727|NCT05944250|144321988|SUPERIORITY|||||||0.15|||||||t-test, 2 sided|||Wounds that reach \>50% healing from baseline per investigator assessment at Month 4||||0.15
72406728|NCT05944250|144321989|SUPERIORITY|||||||1|||||||t-test, 2 sided|||Wounds that reach \>70% healing from baseline per investigator assessment at Month 1||||1
72525653|NCT00113555|144582026|SUPERIORITY||Mean Difference (Net)|-1.16|STANDARD_DEVIATION|1.05|<|0.001|TWO_SIDED|95.0|-1.325|-1.003|||Wilcoxon (Mann-Whitney)|||Wilcoxon's matched pairs signed ranks test was used to determine the significance of differences between scores at follow-up compared to pre-implant.||-1.003|-1.325|<0.001
72525654|NCT02875366|144582060|SUPERIORITY||Least Squares Mean Difference|-3.2||||0.3021|TWO_SIDED|95.0|-9.2|2.9|||Mixed effects model for repeated measure|||||2.9|-9.2|0.3021
72525655|NCT02875366|144582061|SUPERIORITY||Least Squares Mean Difference|-3.2||||0.1894|TWO_SIDED|95.0|-8.0|1.6|||Mixed effects model for repeated measure|||||1.6|-8.0|0.1894
72525656|NCT02875366|144582062|SUPERIORITY||Least Squares Mean Difference|-15.3||||0.2328|TWO_SIDED|95.0|-40.8|10.1|||Mixed effects model for repeated measure|||||10.1|-40.8|0.2328
72625267|NCT01098747|144780084|SUPERIORITY_OR_OTHER||Difference in proportion|72.65|||<|0.001|TWO_SIDED|95.0|61.59|83.71||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1.5 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||83.71|61.59|<0.001
72525657|NCT02875366|144582063|SUPERIORITY||Least Squares Mean Difference|-1.4||||0.1203|TWO_SIDED|95.0|-3.1|0.4|||Mixed effects model for repeated measure|||||0.4|-3.1|0.1203
72525658|NCT02875366|144582064|SUPERIORITY||Least Squares Mean Difference|-149.6||||0.0439|TWO_SIDED|95.0|-295.0|-4.2|||Mixed effects model for repeated measure|||||-4.2|-295.0|0.0439
72525659|NCT02875366|144582065|SUPERIORITY||Least Squares Mean Difference|-7.5||||0.2237|TWO_SIDED|95.0|-19.8|4.7|||Mixed effects model for repeated measure|||||4.7|-19.8|0.2237
72525660|NCT02875366|144582066|SUPERIORITY||Least Squares Mean Difference|-0.6||||0.0226|TWO_SIDED|95.0|-1.12|-0.09|||Mixed effects model for repeated measure|||||-0.09|-1.12|0.0226
72525661|NCT02875366|144582067|SUPERIORITY||Least Squares Mean Difference|-6.32||||0.0613|TWO_SIDED|95.0|-12.94|0.31|||Mixed effects model for repeated measure|||||0.31|-12.94|0.0613
72525662|NCT02875366|144582068|SUPERIORITY||Least Squares Mean Difference|0.3||||0.6409|TWO_SIDED|95.0|-0.9|1.5|||Mixed effects model for repeated measure|||||1.5|-0.9|0.6409
72406729|NCT05944250|144321989|SUPERIORITY|||||||1|||||||t-test, 2 sided|||Wounds that reach \>70% healing from baseline per investigator assessment at Month 2||||1
72406730|NCT05944250|144321989|SUPERIORITY|||||||0.59|||||||t-test, 2 sided|||Wounds that reach \>70% healing from baseline per investigator assessment at Month 3||||0.59
72406731|NCT05944250|144321989|SUPERIORITY|||||||0.09|||||||t-test, 2 sided|||Wounds that reach \>70% healing from baseline per investigator assessment at Month 4||||0.09
72525663|NCT02875366|144582069|SUPERIORITY||Least Squares Mean Difference|1.0||||0.5889|TWO_SIDED|95.0|-2.7|4.7|||Mixed effects model for repeated measure|||||4.7|-2.7|0.5889
72525664|NCT02875366|144582070|SUPERIORITY||Least Squares Mean Difference|3.4||||0.146|TWO_SIDED|95.0|-1.2|8.1|||Mixed effects model for repeated measure|||||8.1|-1.2|0.1460
72406732|NCT04697628|144321993|SUPERIORITY||Cox Proportional Hazard|0.7||||0.0038|TWO_SIDED|95.0|0.54|0.89||Two-sided p-value calculated from stratified log-rank test.|Stratified log-rank test||Hazard Ratio (HR) was calculated from Cox proportional hazards model and Efron method was used in handling ties and computed using stratification factors at randomization.|||0.89|0.54|0.0038
72406733|NCT04697628|144321994|SUPERIORITY||Cox Proportional Hazard|0.67|||<|0.0001|TWO_SIDED|95.0|0.54|0.82||Two-sided p-value calculated from stratified log-rank test.|Stratified log-rank test||HR was calculated from Cox proportional hazards model and Efron method was used in handling ties and computed using stratification factors at randomization.|||0.82|0.54|<0.0001
72406734|NCT04697628|144321995|SUPERIORITY||Odds Ratio (OR)|4.0|||<|0.0001|TWO_SIDED|95.0|2.1|7.6|||Cochran-Mantel-Haenszel||OR calculated using Cochran-Mantel-Haenszel (CMH) method controlling for stratification factors at randomization.|||7.6|2.1|<0.0001
72406735|NCT01946204|144322003|SUPERIORITY||Hazard Ratio (HR)|0.271|||<|0.0001|TWO_SIDED|95.0|0.219|0.335|||Log Rank|||Statistical Analysis for TTM by BICR (US Regulatory)||0.335|0.219|<0.0001
72406736|NCT01946204|144322003|SUPERIORITY||Hazard Ratio (HR)|0.279|||<|0.0001|TWO_SIDED|95.0|0.227|0.342|||Log Rank|||Statistical Analysis for TTM by BICR (Ex-US Regulatory)||0.342|0.227|<0.0001
72406737|NCT01946204|144322004|SUPERIORITY||Hazard Ratio (HR)|0.291|||<|0.0001|TWO_SIDED|95.0|0.238|0.356|||Log Rank|||Statistical Analysis for PFS by BICR (US Regulatory)||0.356|0.238|<0.0001
72406738|NCT01946204|144322004|SUPERIORITY||Hazard Ratio (HR)|0.3|||<|0.0001|TWO_SIDED|95.0|0.247|0.364|||Log Rank|||Statistical Analysis for PFS by BICR (EX-US Regulatory)||0.364|0.247|<0.0001
72406739|NCT01946204|144322005|SUPERIORITY||Hazard Ratio (HR)|0.447|||<|0.0001|TWO_SIDED|95.0|0.315|0.634|||Log Rank|||Statistical Analysis for Time to Symptomatic Progression||0.634|0.315|<0.0001
72406740|NCT01946204|144322008|SUPERIORITY||Hazard Ratio (HR)|0.28|||<|0.0001|TWO_SIDED|95.0|0.227|0.346|||Log Rank|||Statistical Analysis for MFS by BICR (US Regulatory)||0.346|0.227|<0.0001
72625268|NCT01098747|144780084|SUPERIORITY_OR_OTHER||Difference in proportion|17.44||||0.001|TWO_SIDED|95.0|7.83|27.06||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1.5 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||27.06|7.83|0.001
72525665|NCT02875366|144582071|SUPERIORITY||Least Squares Mean Difference|3.5||||0.3091|TWO_SIDED|95.0|-3.4|10.4|||Mixed effects model for repeated measure|||||10.4|-3.4|0.3091
72525666|NCT02875366|144582072|SUPERIORITY||Least Squares Mean Difference|0.2||||0.3961|TWO_SIDED|95.0|-0.3|0.6|||Mixed effects model for repeated measure|||||0.6|-0.3|0.3961
72525667|NCT02875366|144582073|SUPERIORITY||Least Squares Mean Difference|0.9||||0.3905|TWO_SIDED|95.0|-1.2|3.1|||Mixed effects model for repeated measure|||||3.1|-1.2|0.3905
72525668|NCT02875366|144582074|SUPERIORITY||Least Squares Mean Difference|6.2||||0.1257|TWO_SIDED|95.0|-1.8|14.1|||Mixed effects model for repeated measure|||||14.1|-1.8|0.1257
72525669|NCT02141854|144582165|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|0.179||||0.0009|TWO_SIDED|95.0|0.074|0.285||Fixed effects of treatment, sex, (pooled) center, previous therapy (ICS or ICS/LABA), and covariates of age and baseline FEV1.|ANCOVA|||A fixed-sequence multiple testing procedure was used to control the overall Type I error rate at the 0.05 level (2-sided) for the primary endpoints analyses. Analyses appear in the defined sequence. This is the first in the sequence.||0.285|0.074|0.0009
72525670|NCT02141854|144582165|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|0.182||||0.001|TWO_SIDED|95.0|0.074|0.291||Fixed effects of treatment, sex, (pooled) center, previous therapy (ICS or ICS/LABA), and covariates of age and baseline FEV1.|ANCOVA|||A fixed-sequence multiple testing procedure was used to control the overall Type I error rate at the 0.05 level (2-sided) for the primary endpoints analyses. Analyses appear in the defined sequence. This is the second in the sequence.||0.291|0.074|0.0010
72525671|NCT02141854|144582165|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|0.326||||0|TWO_SIDED|95.0|0.221|0.431||Fixed effects of treatment, sex, (pooled) center, previous therapy (ICS or ICS/LABA), and covariates of age and baseline FEV1.|ANCOVA|||A fixed-sequence multiple testing procedure was used to control the overall Type I error rate at the 0.05 level (2-sided) for the primary endpoints analyses. Analyses appear in the defined sequence. This is the third in the sequence.||0.431|0.221|0.0000
72525672|NCT02141854|144582165|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|0.322||||0|TWO_SIDED|95.0|0.212|0.432||Fixed effects of treatment, sex, (pooled) center, previous therapy (ICS or ICS/LABA), and covariates of age and baseline FEV1.|ANCOVA|||A fixed-sequence multiple testing procedure was used to control the overall Type I error rate at the 0.05 level (2-sided) for the primary endpoints analyses. Analyses appear in the defined sequence. This is the fourth in the sequence.||0.432|0.212|0.0000
72525673|NCT02141854|144582166|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|0.276||||0|TWO_SIDED|95.0|0.191|0.361||Effects due to baseline trough AM FEV1, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), and treatment.|ANCOVA|||A fixed-sequence multiple testing procedure was used to control the overall Type I error rate at the 0.05 level (2-sided) for the primary endpoints analyses. Analyses appear in the defined sequence. This is the fifth in the sequence.||0.361|0.191|0.0000
72525674|NCT02141854|144582166|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|0.274||||0|TWO_SIDED|95.0|0.189|0.36||Effects due to baseline trough AM FEV1, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), and treatment.|ANCOVA|||A fixed-sequence multiple testing procedure was used to control the overall Type I error rate at the 0.05 level (2-sided) for the primary endpoints analyses. Analyses appear in the defined sequence. This is the sixth in the sequence.||0.360|0.189|0.0000
72406741|NCT01946204|144322008|SUPERIORITY||Hazard Ratio (HR)|0.297|||<|0.0001|TWO_SIDED|95.0|0.244|0.362|||Log Rank|||Statistical Analysis for MFS by BICR (Ex-US Regulatory)||0.362|0.244|<0.0001
72406742|NCT03466411|144322009|SUPERIORITY||Least Square (LS) Mean Difference|124.2|||<|0.001|TWO_SIDED|95.0|89.8|158.7|||Mixed Model for Repeated Measure||LS Mean difference between the treatment groups and p-values for the comparisons of each guselkumab treatment group with the placebo group were based on MMRM analysis.|||158.7|89.8|<0.001
72525675|NCT02141854|144582166|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|0.183||||0|TWO_SIDED|95.0|0.098|0.268||Effects due to baseline trough AM FEV1, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), and treatment.|ANCOVA|||A fixed-sequence multiple testing procedure was used to control the overall Type I error rate at the 0.05 level (2-sided) for the primary endpoints analyses. Analyses appear in the defined sequence. This is the seventh in the sequence.||0.268|0.098|0.0000
72525676|NCT02141854|144582166|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|0.123||||0.0047|TWO_SIDED|95.0|0.038|0.208||Effects due to baseline trough AM FEV1, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), and treatment.|ANCOVA|||A fixed-sequence multiple testing procedure was used to control the overall Type I error rate at the 0.05 level (2-sided) for the primary endpoints analyses. Analyses appear in the defined sequence. This is the eighth in the sequence.||0.208|0.038|0.0047
72525677|NCT02141854|144582167|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|18.45||||0|TWO_SIDED|95.0|11.751|25.15||Significance level of 0.05.|mixed model for repeated measures|||The analysis of change from baseline in weekly average of daily (AM predose and pre rescue bronchodilator) PEF over the 12-week treatment period was performed using an mixed model for repeated measures (MMRM) with an unstructured covariance matrix and with effects due to baseline weekly average of daily AM PEF, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), week, treatment, and week-by-treatment interaction.||25.150|11.751|0.0000
72525678|NCT02141854|144582167|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|16.718||||0|TWO_SIDED|95.0|9.988|23.449||Significance level of 0.05.|mixed model for repeated measures|||The analysis of change from baseline in weekly average of daily (AM predose and pre rescue bronchodilator) PEF over the 12-week treatment period was performed using an mixed model for repeated measures (MMRM) with an unstructured covariance matrix and with effects due to baseline weekly average of daily AM PEF, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), week, treatment, and week-by-treatment interaction.||23.449|9.988|0.0000
72525679|NCT02141854|144582167|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|31.221||||0|TWO_SIDED|95.0|24.513|37.93||Significance level of 0.05.|mixed model for repeated measures|||The analysis of change from baseline in weekly average of daily (AM predose and pre rescue bronchodilator) PEF over the 12-week treatment period was performed using an mixed model for repeated measures (MMRM) with an unstructured covariance matrix and with effects due to baseline weekly average of daily AM PEF, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), week, treatment, and week-by-treatment interaction.||37.930|24.513|0.0000
72525680|NCT02141854|144582167|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|29.597||||0|TWO_SIDED|95.0|22.839|36.354||Significance level of 0.05.|mixed model for repeated measures|||The analysis of change from baseline in weekly average of daily (AM predose and pre rescue bronchodilator) PEF over the 12-week treatment period was performed using an mixed model for repeated measures (MMRM) with an unstructured covariance matrix and with effects due to baseline weekly average of daily AM PEF, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), week, treatment, and week-by-treatment interaction.||36.354|22.839|0.0000
72525681|NCT02141854|144582167|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|12.771||||0.0002|TWO_SIDED|95.0|6.179|19.363||Significance level of 0.05.|mixed model for repeated measures|||The analysis of change from baseline in weekly average of daily (AM predose and pre rescue bronchodilator) PEF over the 12-week treatment period was performed using an mixed model for repeated measures (MMRM) with an unstructured covariance matrix and with effects due to baseline weekly average of daily AM PEF, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), week, treatment, and week-by-treatment interaction.||19.363|6.179|0.0002
72525682|NCT02141854|144582167|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|12.879||||0.0002|TWO_SIDED|95.0|6.216|19.541||Significance level of 0.05.|mixed model for repeated measures|||The analysis of change from baseline in weekly average of daily (AM predose and pre rescue bronchodilator) PEF over the 12-week treatment period was performed using an mixed model for repeated measures (MMRM) with an unstructured covariance matrix and with effects due to baseline weekly average of daily AM PEF, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), week, treatment, and week-by-treatment interaction.||19.541|6.216|0.0002
72525683|NCT02141854|144582167|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|11.146||||0.001|TWO_SIDED|95.0|4.511|17.782||Significance level of 0.05.|mixed model for repeated measures|||The analysis of change from baseline in weekly average of daily (AM predose and pre rescue bronchodilator) PEF over the 12-week treatment period was performed using an mixed model for repeated measures (MMRM) with an unstructured covariance matrix and with effects due to baseline weekly average of daily AM PEF, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), week, treatment, and week-by-treatment interaction.||17.782|4.511|0.0010
72525684|NCT02141854|144582168|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|-0.156||||0.001|TWO_SIDED|95.0|-0.248|-0.063||Significance level of 0.05.|mixed model for repeated measures|||The change from baseline in the weekly average of the total daily asthma symptom scores over weeks 1 to 12 was analyzed using an MMRM with an unstructured covariance matrix and with effects due to baseline score, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), week, treatment, and week-by-treatment interaction.||-0.063|-0.248|0.0010
72525685|NCT02141854|144582168|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|-0.195||||0|TWO_SIDED|95.0|-0.288|-0.102||Significance level of 0.05.|mixed model for repeated measures|||The change from baseline in the weekly average of the total daily asthma symptom scores over weeks 1 to 12 was analyzed using an MMRM with an unstructured covariance matrix and with effects due to baseline score, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), week, treatment, and week-by-treatment interaction.||-0.102|-0.288|0.0000
72525686|NCT02141854|144582168|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|-0.304||||0|TWO_SIDED|95.0|-0.397|-0.212||Significance level of 0.05.|mixed model for repeated measures|||The change from baseline in the weekly average of the total daily asthma symptom scores over weeks 1 to 12 was analyzed using an MMRM with an unstructured covariance matrix and with effects due to baseline score, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), week, treatment, and week-by-treatment interaction.||-0.212|-0.397|0.0000
72525687|NCT02141854|144582168|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|-0.277||||0|TWO_SIDED|95.0|-0.37|-0.184||Significance level of 0.05.|mixed model for repeated measures|||The change from baseline in the weekly average of the total daily asthma symptom scores over weeks 1 to 12 was analyzed using an MMRM with an unstructured covariance matrix and with effects due to baseline score, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), week, treatment, and week-by-treatment interaction.||-0.184|-0.370|0.0000
72525688|NCT02141854|144582168|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|-0.149||||0.0014|TWO_SIDED|95.0|-0.239|-0.058||Significance level of 0.05.|mixed model for repeated measures|||The change from baseline in the weekly average of the total daily asthma symptom scores over weeks 1 to 12 was analyzed using an MMRM with an unstructured covariance matrix and with effects due to baseline score, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), week, treatment, and week-by-treatment interaction.||-0.058|-0.239|0.0014
72525689|NCT02141854|144582168|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|-0.082||||0.0818|TWO_SIDED|95.0|-0.174|0.01||Significance level of 0.05.|mixed model for repeated measures|||The change from baseline in the weekly average of the total daily asthma symptom scores over weeks 1 to 12 was analyzed using an MMRM with an unstructured covariance matrix and with effects due to baseline score, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), week, treatment, and week-by-treatment interaction.||0.010|-0.174|0.0818
72525690|NCT02141854|144582168|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|-0.121||||0.0094|TWO_SIDED|95.0|-0.213|-0.03||Significance level of 0.05.|mixed model for repeated measures|||The change from baseline in the weekly average of the total daily asthma symptom scores over weeks 1 to 12 was analyzed using an MMRM with an unstructured covariance matrix and with effects due to baseline score, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), week, treatment, and week-by-treatment interaction.||-0.030|-0.213|0.0094
72625269|NCT01098747|144780084|SUPERIORITY_OR_OTHER||Difference in proportion|72.63|||<|0.001|TWO_SIDED|95.0|61.14|84.11||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||2 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||84.11|61.14|<0.001
72625270|NCT01098747|144780084|SUPERIORITY_OR_OTHER||Difference in proportion|11.7||||0.013|TWO_SIDED|95.0|3.47|19.93||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||2 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||19.93|3.47|0.013
72625271|NCT01098747|144780084|SUPERIORITY_OR_OTHER||Difference in proportion|73.58|||<|0.001|TWO_SIDED|95.0|61.83|85.33||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||3 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||85.33|61.83|<0.001
72625272|NCT01098747|144780084|SUPERIORITY_OR_OTHER||Difference in proportion|8.01||||0.041|TWO_SIDED|95.0|1.27|14.75||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||3 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||14.75|1.27|0.041
72625273|NCT01098747|144780084|SUPERIORITY_OR_OTHER||Difference in proportion|73.58|||<|0.001|TWO_SIDED|95.0|61.83|85.33||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||4 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||85.33|61.83|<0.001
72625274|NCT01098747|144780084|SUPERIORITY_OR_OTHER||Difference in proportion|6.79||||0.073|TWO_SIDED|95.0|0.23|13.36||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||4 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||13.36|0.23|0.073
72625275|NCT01098747|144780084|SUPERIORITY_OR_OTHER||Difference in proportion|73.58|||<|0.001|TWO_SIDED|95.0|61.83|85.33||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||5 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||85.33|61.83|<0.001
72625276|NCT01098747|144780084|SUPERIORITY_OR_OTHER||Difference in proportion|6.79||||0.073|TWO_SIDED|95.0|0.23|13.36||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||5 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||13.36|0.23|0.073
72406743|NCT03466411|144322009|SUPERIORITY||LS Mean Difference|102.7|||<|0.001|TWO_SIDED|95.0|68.5|136.9|||Mixed Model for Repeated Measure||LS Mean difference between the treatment groups and p-values for the comparisons of each guselkumab treatment group with the placebo group were based on MMRM analysis.|||136.9|68.5|<0.001
72525691|NCT02141854|144582169|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|-0.702||||0|TWO_SIDED|95.0|-1.001|-0.403||Significance level of 0.05.|mixed model for repeated measures|||The change from baseline in the weekly average of total daily (24-hour) use of albuterol/ salbutamol inhalation aerosol (number of inhalations) over weeks 1 to 12 was analyzed using an MMRM with an unstructured covariance matrix and with effects due to baseline value, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), week, treatment, and week-by-treatment interaction.||-0.403|-1.001|0.0000
72525692|NCT02141854|144582169|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|-0.607||||0.0001|TWO_SIDED|95.0|-0.908|-0.307||Significance level of 0.05.|mixed model for repeated measures|||The change from baseline in the weekly average of total daily (24-hour) use of albuterol/ salbutamol inhalation aerosol (number of inhalations) over weeks 1 to 12 was analyzed using an MMRM with an unstructured covariance matrix and with effects due to baseline value, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), week, treatment, and week-by-treatment interaction.||-0.307|-0.908|0.0001
72525693|NCT02141854|144582169|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|-1.066||||0|TWO_SIDED|95.0|-1.365|-0.766||Significance level of 0.05.|mixed model for repeated measures|||The change from baseline in the weekly average of total daily (24-hour) use of albuterol/ salbutamol inhalation aerosol (number of inhalations) over weeks 1 to 12 was analyzed using an MMRM with an unstructured covariance matrix and with effects due to baseline value, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), week, treatment, and week-by-treatment interaction.||-0.766|-1.365|0.0000
72525694|NCT02141854|144582169|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|-0.989||||0|TWO_SIDED|95.0|-1.291|-0.686||Significance level of 0.05.|mixed model for repeated measures|||The change from baseline in the weekly average of total daily (24-hour) use of albuterol/ salbutamol inhalation aerosol (number of inhalations) over weeks 1 to 12 was analyzed using an MMRM with an unstructured covariance matrix and with effects due to baseline value, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), week, treatment, and week-by-treatment interaction.||-0.686|-1.291|0.0000
72625277|NCT01098747|144780084|SUPERIORITY_OR_OTHER||Difference in proportion|73.58|||<|0.001|TWO_SIDED|95.0|61.83|85.33||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||6 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||85.33|61.83|<0.001
72625278|NCT01098747|144780084|SUPERIORITY_OR_OTHER||Difference in proportion|6.79||||0.073|TWO_SIDED|95.0|0.23|13.36||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||6 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||13.36|0.23|0.073
72525695|NCT02141854|144582169|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|-0.364||||0.016|TWO_SIDED|95.0|-0.659|-0.068||Significance level of 0.05.|mixed model for repeated measures|||The change from baseline in the weekly average of total daily (24-hour) use of albuterol/ salbutamol inhalation aerosol (number of inhalations) over weeks 1 to 12 was analyzed using an MMRM with an unstructured covariance matrix and with effects due to baseline value, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), week, treatment, and week-by-treatment interaction.||-0.068|-0.659|0.0160
72525696|NCT02141854|144582169|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|-0.382||||0.0124|TWO_SIDED|95.0|-0.681|-0.083||Significance level of 0.05.|mixed model for repeated measures|||The change from baseline in the weekly average of total daily (24-hour) use of albuterol/ salbutamol inhalation aerosol (number of inhalations) over weeks 1 to 12 was analyzed using an MMRM with an unstructured covariance matrix and with effects due to baseline value, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), week, treatment, and week-by-treatment interaction.||-0.083|-0.681|0.0124
72571199|NCT00140426|144670807|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.19|STANDARD_ERROR_OF_MEAN|0.26||0.47|TWO_SIDED|95.0|-0.71|0.33|||t-test, 2 sided||The mean difference was for placebo - risperidone.|Null hypothesis: no difference in change from baseline to end of treatment for CAPT total score||0.33|-0.71|0.47
72571200|NCT00140426|144670808|SUPERIORITY_OR_OTHER|||||||0.57|TWO_SIDED||||||t-test, 2 sided|||||||0.57
72571201|NCT00140426|144670809|SUPERIORITY_OR_OTHER|||||||0.5|TWO_SIDED||||||t-test, 2 sided|||||||0.50
72571202|NCT00140426|144670810|SUPERIORITY_OR_OTHER|||||||0.43|TWO_SIDED||||||t-test, 2 sided|||||||0.43
72571203|NCT00140426|144670811|SUPERIORITY_OR_OTHER|||||||0.12|TWO_SIDED||||||t-test, 2 sided|||||||0.12
72571204|NCT02149108|144670812|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.58|||<|0.0001|TWO_SIDED|95.0|0.49|0.69||Hazard ratio, confidence interval and p-value obtained from log-rank test stratified by regorafenib pre-treatment (yes vs no), time from onset metastatic disease until randomisation (less than 24 months vs 24 months or more ) and region.|Log Rank||Hazard ratio \<1 favors Nintedanib.|||0.69|0.49|<0.0001
72406744|NCT03466411|144322009|SUPERIORITY||LS Mean Difference|108.7|||<|0.001|TWO_SIDED|95.0|73.9|143.5|||Mixed Model for Repeated Measure||LS Mean difference between the treatment groups and p-values for the comparisons of each guselkumab treatment group with the placebo group were based on MMRM analysis.|||143.5|73.9|<0.001
72525697|NCT02141854|144582169|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|-0.287||||0.0588|TWO_SIDED|95.0|-0.584|0.011||Significance level of 0.05.|Wilcoxon (Mann-Whitney)|||The change from baseline in the weekly average of total daily (24-hour) use of albuterol/ salbutamol inhalation aerosol (number of inhalations) over weeks 1 to 12 was analyzed using an MMRM with an unstructured covariance matrix and with effects due to baseline value, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), week, treatment, and week-by-treatment interaction.||0.011|-0.584|0.0588
72571205|NCT02149108|144670813|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.01||||0.8659|TWO_SIDED|95.0|0.86|1.19||Hazard ratio, confidence interval and p-value obtained from log-rank test stratified by regorafenib pre-treatment (yes vs no), time from onset metastatic disease until randomisation (less than 24 months vs 24 months or more ) and region.|Log Rank||Hazard ratio below 1 favors Nintedanib.|||1.19|0.86|0.8659
72571206|NCT02149108|144670815|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.96|||<|0.0001|TWO_SIDED|95.0|2.0|4.47||Odds ratio and p-value are obtained from logistic regression model adjusted for regorafenib pre-treatment (yes vs no), time from onset metastatic disease until randomization in the trial (less than 24 months vs. 24 months or more) and region.|Regression, Logistic||An odds ratio \>1 indicates benefit to Nintedanib.|||4.47|2.00|<0.0001
72571207|NCT00655876|144670845|SUPERIORITY||Hazard Ratio (HR)|0.9||||0.47|TWO_SIDED|95.0|0.7|1.16|||Log Rank|||The sample size was based on the primary hypothesis of a 29% reduction in the hazard rate of death with cetuximab, corresponding to an increase in 2-year overall survival (OS) from 41% to 53% and a hazard ratio (λ\[exp\]/λ\[cont\]) of 0.71 in favor of the cetuximab arm. Assuming an exponential distribution and constant hazards, 400 patients were required to reach 281 OS events, with 80% statistical power, a 1-sided α of 0.025, 4.5 years of accrual, 2 years of follow-up, and 4 interim analyses.||1.16|0.70|0.47
72571208|NCT00655876|144670846|SUPERIORITY||Hazard Ratio (HR)|0.92||||0.65|TWO_SIDED|95.0|0.66|1.28|||Log Rank|One-sided significance level = 0.025||||1.28|0.66|0.65
72571209|NCT00655876|144670848|SUPERIORITY|||||||0.66|||||||Fisher Exact|One-sided significance level = 0.025||||||0.66
72571210|NCT00655876|144670849|SUPERIORITY|||||||0.04|||||||Chi-squared|Two-sided significance level = 0.05||6-8 weeks post-treatment||||0.04
72571211|NCT00655876|144670849|SUPERIORITY|||||||0.77|||||||Chi-squared|Two-sided significance level = 0.05||1 year||||0.77
72571212|NCT00655876|144670849|SUPERIORITY|||||||0.17|||||||Chi-squared|Two-sided significance level = 0.05||2 years||||0.17
72571213|NCT01831765|144670851|NON_INFERIORITY_OR_EQUIVALENCE|The assessment was done by comparing the difference of faster aspart vs. NovoRapid®/NovoLog® in change from baseline in HbA1c after 26 weeks of randomised treatment to a non-inferiority limit of 0.4%.|Mean Difference (Net)|-0.15|||||TWO_SIDED|95.0|-0.23|-0.07||||||Change from baseline in HbA1c analysed using a mixed effect model for repeated measurements including visit 14, 18, 22, 26, 30, 34 and 36. The model included treatment, region and strata (combination of bolus adjusting method, basal treatment regimen and continuous glucose monitoring (CGM) and frequently sampled meal test subgroup) as fixed effects, subject as random effect, baseline HbA1c as covariate and interaction between all fixed effects and visit, and between the covariate and visit.||-0.07|-0.23|
72571214|NCT01831765|144670851|NON_INFERIORITY_OR_EQUIVALENCE|The assessment was done by comparing the difference of faster aspart vs. NovoRapid®/NovoLog® in change from baseline in HbA1c after 26 weeks of randomised treatment to a non-inferiority limit of 0.4%.|Mean Difference (Net)|0.04|||||TWO_SIDED|95.0|-0.04|0.12||||||Change from baseline in HbA1c analysed using a mixedeffect model for repeated measurements including visit 14, 18, 22, 26, 30, 34 and 36. The model included treatment, region and strata (combination of bolus adjusting method, basal treatment regimen and continuous glucose monitoring (CGM) and frequently sampled meal test subgroup) as fixed effects, subject as random effect, baseline HbA1c as covariate and interaction between all fixed effects and visit, and between the covariate and visit.||0.12|-0.04|
72571215|NCT02992418|144670910|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of the two-sided 95% confidence interval (CI) of the ratio of GMCs between groups (Group 1/ Group 2) was greater than (\>) 1/1.5 for each antigen. Overall non-inferiority was demonstrated if the 4 antigens achieved non-inferiority.|GMC ratio|0.848|||||TWO_SIDED|95.0|0.721|0.997||||||Anti-PT||0.997|0.721|
72525698|NCT02141854|144582170|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0001||||||Significance level of 0.05.|Log Rank|||||||0.0001
72525699|NCT02141854|144582170|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Significance level of 0.05.|Log Rank|||||||<.0001
72406745|NCT03466411|144322010|SUPERIORITY||Adjusted treatment difference|38.1|||<|0.001|TWO_SIDED|95.0|27.3|48.9|||Mantel Haenszel||Treatment difference between guselkumab group and placebo group was based on the common risk difference by use of Mantel- Haenszel stratum weights and the Sato variance estimator.|||48.9|27.3|<0.001
72525700|NCT02141854|144582170|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0003||||||Significance level of 0.05.|Log Rank|||||||0.0003
72525701|NCT02141854|144582170|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Significance level of 0.05.|Log Rank|||||||<.0001
72525702|NCT02141854|144582170|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7203||||||Significance level of 0.05.|Log Rank|||||||0.7203
72525703|NCT02141854|144582170|SUPERIORITY_OR_OTHER_LEGACY|||||||0.996||||||Significance level of 0.05.|Log Rank|||||||0.9960
72525704|NCT02141854|144582170|SUPERIORITY_OR_OTHER_LEGACY|||||||0.325||||||Significance level of 0.05.|Log Rank|||||||0.3250
72406746|NCT03466411|144322010|SUPERIORITY||Adjusted treatment difference|42.8|||<|0.001|TWO_SIDED|95.0|31.6|53.9|||Mantel Haenszel||Treatment difference between guselkumab group and placebo group was based on the common risk difference by use of Mantel-Haenszel stratum weights and the Sato variance estimator.|||53.9|31.6|<0.001
72406747|NCT03466411|144322011|SUPERIORITY||Adjusted treatment difference|33.7|||<|0.001|TWO_SIDED|95.0|24.1|43.2|||Mantel Haenszel||Treatment difference between guselkumab group and placebo group was based on the common risk difference by use of Mantel- Haenszel stratum weights and the Sato variance estimator.|||43.2|24.1|<0.001
72406748|NCT03466411|144322011|SUPERIORITY||Adjusted treatment difference|32.9|||<|0.001|TWO_SIDED|95.0|23.5|42.4|||Mantel Haenszel||Treatment difference between guselkumab group and placebo group was based on the common risk difference by use of Mantel-Haenszel stratum weights and the Sato variance estimator.|||42.4|23.5|<0.001
72406749|NCT03466411|144322012|SUPERIORITY||Adjusted treatment difference|34.2|||<|0.001|TWO_SIDED|95.0|23.2|45.3|||Mantel Haenszel||Treatment difference between guselkumab group and placebo group was based on the common risk difference by use of Mantel- Haenszel stratum weights and the Sato variance estimator.|||45.3|23.2|<0.001
72406750|NCT03466411|144322012|SUPERIORITY||Adjusted treatment difference|35.0|||<|0.001|TWO_SIDED|95.0|23.5|46.5|||Mantel Haenszel||Treatment difference between guselkumab group and placebo group was based on the common risk difference by use of Mantel-Haenszel stratum weights and the Sato variance estimator.|||46.5|23.5|<0.001
72406751|NCT03466411|144322013|SUPERIORITY||Adjusted treatment difference|27.9|||<|0.001|TWO_SIDED|95.0|18.7|37.1|||Mantel Haenszel||Treatment difference between guselkumab group and placebo group was based on the common risk difference by use of Mantel-Haenszel stratum weights and the Sato variance estimator.|||37.1|18.7|<0.001
72406752|NCT03466411|144322013|SUPERIORITY||Adjusted treatment difference|30.8|||<|0.001|TWO_SIDED|95.0|21.3|40.3|||Mantel Haenszel||Treatment difference between guselkumab group and placebo group was based on the common risk difference by use of Mantel-Haenszel stratum weights and the Sato variance estimator.|||40.3|21.3|<0.001
72525705|NCT02141854|144582171|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|0.473||||0|TWO_SIDED|95.0|0.269|0.677||Significance level of 0.05.|ANCOVA|||The change from baseline in AQLQ(S) score (patients ≥18 years of age) at endpoint (ie, last postbaseline observation) was analyzed using an ANCOVA model with effects due to baseline AQLQ(S) score, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), and treatment, imputing missing data via last observation carried forward (LOCF).||0.677|0.269|0.0000
72406753|NCT03466411|144322014|SUPERIORITY||Adjusted treatment difference|25.1|||<|0.001|TWO_SIDED|95.0|14.1|36.2|||Mantel Haenszel||Treatment difference between combined guselkumab group and placebo group was based on the common risk difference by use of Mantel- Haenszel stratum weights and the Sato variance estimator.|||36.2|14.1|<0.001
72406754|NCT03466411|144322015|SUPERIORITY||Adjusted treatment difference|27.7|||<|0.001|TWO_SIDED|95.0|19.3|36.1|||Mantel Haenszel||Treatment difference between combined guselkumab group and placebo group was based on the common risk difference by use of Mantel- Haenszel stratum weights and the Sato variance estimator.|||36.1|19.3|<0.001
72406755|NCT03466411|144322016|SUPERIORITY||Adjusted treatment difference|31.2|||<|0.001|TWO_SIDED|95.0|21.1|41.3|||Mantel Haenszel||Treatment difference between combined guselkumab group and placebo group was based on the common risk difference by use of Mantel- Haenszel stratum weights and the Sato variance estimator.|||41.3|21.1|<0.001
72525706|NCT02141854|144582171|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|0.428||||0|TWO_SIDED|95.0|0.224|0.632||Significance level of 0.05.|ANCOVA|||The change from baseline in AQLQ(S) score (patients ≥18 years of age) at endpoint (ie, last postbaseline observation) was analyzed using an ANCOVA model with effects due to baseline AQLQ(S) score, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), and treatment, imputing missing data via last observation carried forward (LOCF).||0.632|0.224|0.0000
72525707|NCT02141854|144582171|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|0.623||||0|TWO_SIDED|95.0|0.418|0.828||Significance level of 0.05.|ANCOVA|||The change from baseline in AQLQ(S) score (patients ≥18 years of age) at endpoint (ie, last postbaseline observation) was analyzed using an ANCOVA model with effects due to baseline AQLQ(S) score, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), and treatment, imputing missing data via last observation carried forward (LOCF).||0.828|0.418|0.0000
72525708|NCT02141854|144582171|SUPERIORITY_OR_OTHER_LEGACY||Slope|0.681||||0|TWO_SIDED|95.0|0.478|0.885||Significance level of 0.05.|ANCOVA|||The change from baseline in AQLQ(S) score (patients ≥18 years of age) at endpoint (ie, last postbaseline observation) was analyzed using an ANCOVA model with effects due to baseline AQLQ(S) score, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), and treatment, imputing missing data via last observation carried forward (LOCF).||0.885|0.478|0.0000
72525709|NCT02141854|144582171|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|0.15||||0.149|TWO_SIDED|95.0|-0.054|0.354||Significance level of 0.05.|ANCOVA|||The change from baseline in AQLQ(S) score (patients ≥18 years of age) at endpoint (ie, last postbaseline observation) was analyzed using an ANCOVA model with effects due to baseline AQLQ(S) score, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), and treatment, imputing missing data via last observation carried forward (LOCF).||0.354|-0.054|0.1490
72406756|NCT03466411|144322017|SUPERIORITY||Adjusted treatment difference|22.1|||<|0.001|TWO_SIDED|95.0|12.2|31.9|||Mantel Haenszel||Treatment difference between combined guselkumab group and placebo group was based on the common risk difference by use of Mantel- Haenszel stratum weights and the Sato variance estimator.|||31.9|12.2|<0.001
72525710|NCT02141854|144582171|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|0.253||||0.0143|TWO_SIDED|95.0|0.051|0.455||Significance level of 0.05.|ANCOVA|||The change from baseline in AQLQ(S) score (patients ≥18 years of age) at endpoint (ie, last postbaseline observation) was analyzed using an ANCOVA model with effects due to baseline AQLQ(S) score, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), and treatment, imputing missing data via last observation carried forward (LOCF).||0.455|0.051|0.0143
72571216|NCT02992418|144670910|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of the two-sided 95% CI of the ratio of GMCs between groups (Group 1/ Group 2) was \> 1/1.5 for each antigen. Overall non-inferiority was demonstrated if the 4 antigens achieved non-inferiority.|GMC ratio|1.02|||||TWO_SIDED|95.0|0.892|1.18||||||Anti-FHA||1.18|0.892|
72406757|NCT00393939|144322048|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.9222||||0.2651|TWO_SIDED|95.0|0.7156|1.1885||1-sided stratified log-rank test adjusted for baseline stratification factors (number of metastatic sites, estrogen receptor status, and disease-free interval from prior adjuvant treatment)|Log Rank|||Independent radiology assessment||1.1885|0.7156|0.2651
72406758|NCT00393939|144322048|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.856||||0.0753|TWO_SIDED|95.0|0.6921|1.0589||1-sided stratified log-rank test adjusted for baseline stratification factors (number of metastatic sites, estrogen receptor status, and disease-free interval from prior adjuvant treatment)|Log Rank|||Investigator's assessment||1.0589|0.6921|0.0753
72406759|NCT00393939|144322049|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.65||||0.0018|TWO_SIDED|95.0|1.17|2.33||1-sided stratified log-rank test adjusted for baseline stratification factors (number of metastatic sites, estrogen receptor status, and disease-free interval from prior adjuvant treatment)|Cochran-Mantel-Haenszel|||Independent radiology assessment||2.33|1.17|0.0018
72406760|NCT00393939|144322049|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.44||||0.0172|TWO_SIDED|95.0|1.03|2.02||1-sided stratified log-rank test adjusted for baseline stratification factors (number of metastatic sites, estrogen receptor status, and disease-free interval from prior adjuvant treatment)|Cochran-Mantel-Haenszel|||Investigator's assessment||2.02|1.03|0.0172
72406761|NCT00393939|144322051|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.1539||||0.8933|TWO_SIDED|95.0|0.9209|1.4458||1-sided stratified log-rank test adjusted for baseline stratification factors (number of metastatic sites, estrogen receptor status, and disease-free interval from prior adjuvant treatment)|Log Rank|||||1.4458|0.9209|0.8933
72406762|NCT03778931|144322055|OTHER||Hazard Ratio (HR)|0.546||||0.0005|TWO_SIDED|95.0|0.387|0.768|||Log Rank|The p-value was generated by using a two-sided stratified log-rank test.||The analysis was performed using a stratified Cox Proportional Hazards model with ties=Efron and the stratification factors: prior treatment with fulvestrant (yes vs no) and presence of visceral metastases (yes vs no); the CI calculated using a profile likelihood approach.||0.768|0.387|0.0005
72525711|NCT02141854|144582171|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|0.209||||0.0435|TWO_SIDED|95.0|0.006|0.411||Significance level of 0.05.|ANCOVA|||The change from baseline in AQLQ(S) score (patients ≥18 years of age) at endpoint (ie, last postbaseline observation) was analyzed using an ANCOVA model with effects due to baseline AQLQ(S) score, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), and treatment, imputing missing data via last observation carried forward (LOCF).||0.411|0.006|0.0435
72625279|NCT01098747|144780084|SUPERIORITY_OR_OTHER||Difference in proportion|74.71|||<|0.001|TWO_SIDED|95.0|63.14|86.27||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||7 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||86.27|63.14|<0.001
72625280|NCT01098747|144780084|SUPERIORITY_OR_OTHER||Difference in proportion|7.84||||0.035|TWO_SIDED|95.0|1.57|14.1||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||7 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||14.10|1.57|0.035
72625281|NCT01098747|144780084|SUPERIORITY_OR_OTHER||Difference in proportion|72.61|||<|0.001|TWO_SIDED|95.0|61.05|84.17||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||8 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||84.17|61.05|<0.001
72406763|NCT03778931|144322056|OTHER||Hazard Ratio (HR)|0.697||||0.0018|TWO_SIDED|95.0|0.552|0.88|||Log Rank|The p-value was generated by using a two-sided stratified log-rank test.||The analysis was performed using a stratified Cox Proportional Hazards model with ties=Efron and the stratification factors: prior treatment with fulvestrant (yes vs no) and presence of visceral metastases (yes vs no); the CI calculated using a profile likelihood approach.||0.880|0.552|0.0018
72406764|NCT03778931|144322057|OTHER||Hazard Ratio (HR)|0.592||||0.0325|TWO_SIDED|95.0|0.361|0.958||The p-value was generated by using a two-sided stratified log-rank test.|Log Rank|||The analysis was performed using a stratified Cox Proportional Hazards model with ties=Efron and the stratification factors: prior treatment with fulvestrant (yes vs no) and presence of visceral metastases (yes vs no); the CI calculated using a profile likelihood approach.||0.958|0.361|0.0325
72525712|NCT03128307|144582182|SUPERIORITY||||||<|0.0001||||||Assuming a priori threshold for statistical significant of p = 0.05|t-test, 2 sided|||||||< 0.0001
72525713|NCT03128307|144582183|SUPERIORITY||||||<|0.0001||||||a priori threshold for statistical significance of p = 0.05|t-test, 2 sided|||||||< 0.0001
72525714|NCT02987205|144582193|NON_INFERIORITY|If the upper bound of this 95% CI was less than the prespecified non-inferiority limit of 0.50, the Test product would be claimed to be non-inferior to the Comparator product.||||||0.013||||||Wilcoxon matched-pairs signed rank test|Wilcoxon (Mann-Whitney)|||||||0.0130
72525715|NCT02362594|144582198|SUPERIORITY||Hazard Ratio (HR)|0.57|||<|0.0001|TWO_SIDED|98.4|0.43|0.74||One-sided p-value based on log-rank test.|Regression, Cox|||Comparison of RFS time-to-event distribution between the 2 treatment arms was based on Cox regression model with treatment as a covariate stratified by stage (IIIA \[\>1 mm metastasis\] vs. IIIB vs. IIIC 1-3 nodes vs. IIIC ≥4 nodes) as indicated at randomization.||0.74|0.43|<0.0001
72525716|NCT02362594|144582199|SUPERIORITY||Hazard Ratio (HR)|0.54|||<|0.0001|TWO_SIDED|95.0|0.42|0.69||One-sided p-value based on log-rank test.|Regression, Cox|||Comparison of RFS time-to-event distribution between the 2 treatment arms (PD-L1-positive participants) was based on Cox regression model with treatment as a covariate stratified by stage (IIIA \[\>1 mm metastasis\] vs. IIIB vs. IIIC 1-3 nodes vs. IIIC ≥4 nodes) as indicated at randomization.||0.69|0.42|<0.0001
72525717|NCT04167514|144582209|SUPERIORITY||Odds Ratio (OR)|1.92||||0.034|TWO_SIDED|95.0|0.954|3.866|||One-sided Wald|One-sided Wald test of superior odds of overall response under AAT treatment compared to placebo.Threshold of significance at \<0.025.|Wald CIs|||3.866|0.954|0.034
72542570|NCT01120600|144614974|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-7.94|||=|0.019|TWO_SIDED|95.0|-14.58|-1.31|||cLDA|||A cLDA method was used for this statistical analysis. The cLDA model included the baseline measurement and all post-baseline percent changes from baseline in the response vector, with fixed effects for treatment, time, geographic region, machine type and treatment-by-time interaction, geographic region-by-time interaction, and machine type-by-time interaction.||-1.31|-14.58|= 0.019
72571217|NCT02992418|144670910|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of the two-sided 95% CI of the ratio of GMCs between groups (Group 1/ Group 2) was \> 1/1.5 for each antigen. Overall non-inferiority was demonstrated if the 4 antigens achieved non-inferiority.|GMC ratio|1.11|||||TWO_SIDED|95.0|0.836|1.46||||||Anti-PRN||1.46|0.836|
72571218|NCT02992418|144670910|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of the two-sided 95% CI of the ratio of GMCs between groups (Group 1/ Group 2) was \> 1/1.5 for each antigen. Overall non-inferiority was demonstrated if the 4 antigens achieved non-inferiority.|GMC ratio|1.05|||||TWO_SIDED|95.0|0.827|1.33||||||Anti-FIM2+3||1.33|0.827|
72571219|NCT02992418|144670911|NON_INFERIORITY|The non-inferiority was demonstrated if the lower limit of all the 95% CI of the percentage difference was \> -10% for all antigens.|Percentage difference|0.26|||||TWO_SIDED|95.0|-4.53|5.04||||||Anti-D||5.04|-4.53|
72571220|NCT02992418|144670911|NON_INFERIORITY|The non-inferiority was demonstrated if the lower limit of all the 95% CI of the percentage difference was \> -10% for all antigens.|Percentage difference|-0.66|||||TWO_SIDED|95.0|-2.87|1.37||||||Anti-T||1.37|-2.87|
72571221|NCT02992418|144670912|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of the two-sided 95% CI of the ratio of GMTs between groups (Group 1/Group 2) was \> 1/2 for each serotype. Overall non-inferiority was demonstrated if all 4 serotypes achieved non-inferiority.|GMT ratio|1.11|||||TWO_SIDED|95.0|0.862|1.44||||||Serotype 1||1.44|0.862|
72571222|NCT02992418|144670912|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of the two-sided 95% CI of the ratio of GMTs between groups (Group 1/Group 2) was \> 1/2 for each serotype. Overall non-inferiority was demonstrated if all 4 serotypes achieved non-inferiority.|GMT ratio|1.19|||||TWO_SIDED|95.0|0.97|1.47||||||Serotype 2||1.47|0.97|
72571223|NCT02992418|144670912|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of the two-sided 95% CI of the ratio of GMTs between groups (Group 1/Group 2) was \> 1/2 for each serotype. Overall non-inferiority was demonstrated if all 4 serotypes achieved non-inferiority.|GMT ratio|0.925|||||TWO_SIDED|95.0|0.739|1.16||||||Serotype 3||1.16|0.739|
72625282|NCT01098747|144780084|SUPERIORITY_OR_OTHER||Difference in proportion|7.28||||0.047|TWO_SIDED|95.0|1.07|13.48||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||8 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||13.48|1.07|0.047
72625283|NCT01098747|144780085|SUPERIORITY_OR_OTHER||Difference in proportion|20.01||||0.004|TWO_SIDED|95.0|8.79|31.24||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||0.25 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||31.24|8.79|0.004
72625284|NCT01098747|144780085|SUPERIORITY_OR_OTHER||Difference in proportion|14.35||||0.003|TWO_SIDED|95.0|4.26|24.43||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||0.25 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||24.43|4.26|0.003
72525718|NCT03345849|144582221|SUPERIORITY|The overall type I error rate of the co-primary and ranked secondary endpoints were strongly controlled using a fixed sequence multiple-testing procedure as well as a Holm procedure. The testing utilized the sequence of hypothesis testing for the co-primary endpoints using two-sided α of 0.05 followed by a set of ranked key secondary endpoints, defined separately for US/FDA and European Union/European Medicines Agency regulatory purposes.|Adjusted Response Rate Difference|20.8|||<|0.0001|TWO_SIDED|95.0|12.7|28.8|||Cochran-Mantel-Haenszel|Cochran Mantel-Haenszel test adjusted for stratification factors.|Adjusted response rate difference (Upadacitinib - Placebo) calculated based on CMH test adjusted for stratification factors.|Comparison of the upadacitinib group and placebo group was performed using the Cochran Mantel-Haenszel (CMH) test adjusting for stratification factors (baseline steroid use \[Yes, No\], endoscopic disease severity \[SES-CD \< 15, ≥ 15\] and number of prior biologics with prior inadequate response or intolerance \[0, 1, \> 1\]).||28.8|12.7|<0.0001
72525719|NCT03345849|144582222|SUPERIORITY|The overall type I error rate of the co-primary and ranked secondary endpoints were strongly controlled using a fixed sequence multiple-testing procedure as well as a Holm procedure. The testing utilized the sequence of hypothesis testing for the co-primary endpoints using two-sided α of 0.05 followed by a set of ranked key secondary endpoints, defined separately for US/FDA and EU/EMA regulatory purposes.|Adjusted Response Rate Difference|28.7|||<|0.0001|TWO_SIDED|95.0|20.9|36.4|||Cochran-Mantel-Haenszel|Cochran Mantel-Haenszel test adjusted for stratification factors.|Adjusted response rate difference (Upadacitinib - Placebo) calculated based on CMH test adjusted for stratification factors.|||36.4|20.9|<0.0001
72525720|NCT03345849|144582223|SUPERIORITY|The overall type I error rate of the co-primary and ranked secondary endpoints were strongly controlled using a fixed sequence multiple-testing procedure as well as a Holm procedure. The testing utilized the sequence of hypothesis testing for the co-primary endpoints using two-sided α of 0.05 followed by a set of ranked key secondary endpoints, defined separately for US/FDA and EU/EMA regulatory purposes.|Adjusted Response Rate Difference|33.0|||<|0.0001|TWO_SIDED|95.0|26.2|39.9|||Cochran-Mantel-Haenszel|Cochran Mantel-Haenszel test adjusted for stratification factors.|Adjusted response rate difference (Upadacitinib - Placebo) calculated based on CMH test adjusted for stratification factors.|||39.9|26.2|<0.0001
72525721|NCT03345849|144582224|SUPERIORITY|The overall type I error rate of the co-primary and ranked secondary endpoints were strongly controlled using a fixed sequence multiple-testing procedure as well as a Holm procedure. The testing utilized the sequence of hypothesis testing for the co-primary endpoints using two-sided α of 0.05 followed by a set of ranked key secondary endpoints, defined separately for US/FDA and EU/EMA regulatory purposes.|Adjusted Response Rate Difference|21.8|||<|0.0001|TWO_SIDED|95.0|15.8|27.8|||Cochran-Mantel-Haenszel|Cochran Mantel-Haenszel test adjusted for stratification factors.|Adjusted response rate difference (Upadacitinib - Placebo) calculated based on CMH test adjusted for stratification factors.|||27.8|15.8|<0.0001
72571224|NCT02992418|144670912|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of the two-sided 95% CI of the ratio of GMTs between groups (Group 1/Group 2) was \> 1/2 for each serotype. Overall non-inferiority was demonstrated if all 4 serotypes achieved non-inferiority.|GMT ratio|0.802|||||TWO_SIDED|95.0|0.644|0.999||||||Serotype 4||0.999|0.644|
72406765|NCT03778931|144322058|OTHER||Hazard Ratio (HR)|0.742||||0.0697|TWO_SIDED|95.0|0.536|1.025|||Log Rank|The p-value was generated by using a two-sided stratified log-rank test.|Applied a stratified Cox Proportional Hazards model with ties=Efron and the stratification factors: ESR1-mutational status (ESR1-mut vs ESR1-wt), prior treatment with fulvestrant (yes vs no) and presence of visceral metastases (yes vs no).|||1.025|0.536|0.0697
72406766|NCT00087633|144322061|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.2||||0.725|TWO_SIDED|95.0|-20.8|14.4|||Cochran-Mantel-Haenszel|||||14.4|-20.8|0.725
72406767|NCT03985813|144322063|SUPERIORITY|||||||0.083||||||Threshold for significance P\<0.05|Chi-squared|||||||0.083
72406768|NCT03985813|144322064|SUPERIORITY||||||>|0.99||||||Threshold for statistical significance P\<0.05|Chi-squared|||||||>0.99
72406769|NCT01857063|144322091|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares (LS) Means|-0.01||||0.913|TWO_SIDED|95.0|-0.11|0.1||Longitudinal Data Analysis (LDA) model with baseline TNSS as a covariate, sequence, treatment and period as fixed effects and participant as a random effect.|Longitudinal Data Analysis (LDA)|||||0.10|-0.11|0.913
72406770|NCT01857063|144322093|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|0.0||||0.953|TWO_SIDED|95.0|-0.17|0.16||Longitudinal Data Analysis (LDA) model with baseline Weighted TNSS as a covariate, sequence, treatment and period as fixed effects and participant as a random effect.|LDA|||||0.16|-0.17|0.953
72406771|NCT01857063|144322094|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|0.0||||0.974|TWO_SIDED|95.0|-0.07|0.07||Longitudinal Data Analysis (LDA) model with baseline nasal congestion score as a covariate, sequence, treatment and period as fixed effects and participant as a random effect.|LDA|||||0.07|-0.07|0.974
72525722|NCT03345849|144582225|SUPERIORITY|The overall type I error rate of the co-primary and ranked secondary endpoints were strongly controlled using a fixed sequence multiple-testing procedure as well as a Holm procedure. The testing utilized the sequence of hypothesis testing for the co-primary endpoints using two-sided α of 0.05 followed by a set of ranked key secondary endpoints. This endpoint was a ranked key secondary endpoint for US/FDA regulatory purposes.|Adjusted Response Rate Difference|27.7|||<|0.0001|TWO_SIDED|95.0|15.7|39.8|||Cochran-Mantel-Haenszel|Cochran Mantel-Haenszel test adjusted for stratification factors endoscopic disease severity and number of prior failed biologic therapies.|Adjusted response rate difference (Upadacitinib - Placebo) calculated based on CMH test adjusted for stratification factors endoscopic disease severity and number of prior biologic failed.|||39.8|15.7|<0.0001
72525723|NCT03345849|144582226|SUPERIORITY|The overall type I error rate of the co-primary and ranked secondary endpoints were strongly controlled using a fixed sequence multiple-testing procedure as well as a Holm procedure. The testing utilized the sequence of hypothesis testing for the co-primary endpoints using two-sided α of 0.05 followed by a set of ranked key secondary endpoints, defined separately for US/FDA and EU/EMA regulatory purposes.|Least Squares (LS) Mean Difference|6.3|STANDARD_ERROR_OF_MEAN|1.05|<|0.0001|TWO_SIDED|95.0|4.2|8.3|||Mixed-effect Model Repeated Measurement|MMRM model with fixed effects of treatment, visit, and treatment-by-visit interaction, stratification factors, and Baseline value as covariate.||||8.3|4.2|<0.0001
72406772|NCT01857063|144322095|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.03||||0.182|TWO_SIDED|95.0|-0.06|0.01||Longitudinal Data Analysis (LDA) model with baseline nasal discharge score as a covariate, sequence, treatment and period as fixed effects and participant as a random effect.|LDA|||||0.01|-0.06|0.182
72571225|NCT01992523|144670944|SUPERIORITY_OR_OTHER|||||||0.006|TWO_SIDED||||||t-test, 2 sided|||Continuous data were expressed as mean ± standard deviation or medians (quartiles) as appropriate, and categorical data as proportions (%). Data were compared by means of the chi-2 test or Fisher exact test for categorical variables and unpaired t test or Mann-Whitney U-test for continuous variables, as appropriate. A P value \< .05 was considered statistically significant. All tests were two-sided.||||0.006
72406773|NCT01857063|144322096|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|0.02||||0.161|TWO_SIDED|95.0|-0.01|0.05||Longitudinal Data Analysis (LDA) model with baseline sneezing score as a covariate, sequence, treatment and period as fixed effects and participant as a random effect.|LDA|||||0.05|-0.01|0.161
72406774|NCT04115358|144322102|SUPERIORITY||||||>|0.05|||||||Chi-squared|||Chi-Square Test was used to compare qualitative data.The results were evaluated at the significance level of p\<0,05.||||>0.05
72406775|NCT04115358|144322103|SUPERIORITY||||||>|0.05|||||||Chi-squared|||Chi-Square Test was used to compare qualitative data.The results were evaluated at the significance level of p\<0,05.||||>0.05
72406776|NCT04115358|144322104|SUPERIORITY||||||>|0.05|||||||Chi-squared|||Chi-Square Test was used to compare qualitative data.The results were evaluated at the significance level of p\<0,05.||||>0.05
72406777|NCT04115358|144322105|SUPERIORITY||||||>|0.05|||||||Chi-squared|||Chi-Square Test was used to compare qualitative data.The results were evaluated at the significance level of p\<0,05.||||>0.05
72406778|NCT04115358|144322106|SUPERIORITY||||||>|0.05|||||||Chi-squared|||Chi-Square Test was used to compare qualitative data.The results were evaluated at the significance level of p\<0,05.||||>0.05
72406779|NCT04115358|144322107|SUPERIORITY||||||>|0.05|||||||Chi-squared|||Chi-Square Test was used to compare qualitative data.The results were evaluated at the significance level of p\<0,05.||||>0.05
72406780|NCT04115358|144322108|SUPERIORITY||||||>|0.05|||||||Chi-squared|||Chi-Square Test was used to compare qualitative data.The results were evaluated at the significance level of p\<0,05.||||>0.05
72406781|NCT04115358|144322109|SUPERIORITY||||||>|0.05|||||||Chi-squared|||Chi-Square Test was used to compare qualitative data.The results were evaluated at the significance level of p\<0,05.||||>0.05
72406782|NCT04115358|144322110|SUPERIORITY||||||>|0.05|||||||Chi-squared|||Chi-Square Test was used to compare qualitative data.The results were evaluated at the significance level of p\<0,05.||||>0.05
72406783|NCT04115358|144322111|SUPERIORITY||||||>|0.05|||||||Chi-squared|||Chi-Square Test was used to compare qualitative data.The results were evaluated at the significance level of p\<0,05.||||>0.05
72406784|NCT04115358|144322112|SUPERIORITY||||||>|0.05|||||||Chi-squared|||Chi-Square Test was used to compare qualitative data.The results were evaluated at the significance level of p\<0,05.||||>0.05
72406785|NCT04115358|144322113|SUPERIORITY||||||>|0.05|||||||Chi-squared|||Chi-Square Test was used to compare qualitative data.The results were evaluated at the significance level of p\<0,05.||||>0.05
72406786|NCT04115358|144322114|SUPERIORITY||||||>|0.05|||||||Chi-squared|||Chi-Square Test was used to compare qualitative data.The results were evaluated at the significance level of p\<0,05.||||>0.05
72525724|NCT03345849|144582227|SUPERIORITY|The overall type I error rate of the co-primary and ranked secondary endpoints were strongly controlled using a fixed sequence multiple-testing procedure as well as a Holm procedure. The testing utilized the sequence of hypothesis testing for the co-primary endpoints using two-sided α of 0.05 followed by a set of ranked key secondary endpoints, defined separately for US/FDA and EU/EMA regulatory purposes.|LS Mean Difference|21.842|STANDARD_ERROR_OF_MEAN|3.1933|<|0.0001|TWO_SIDED|95.0|15.566|28.118|||Mixed-effect Model Repeated Measurement|MMRM model with fixed effects of treatment, visit, and treatment-by-visit interaction, stratification factors, and Baseline value as covariate.||||28.118|15.566|<0.0001
72525725|NCT03345849|144582228|SUPERIORITY|The overall type I error rate of the co-primary and ranked secondary endpoints were strongly controlled using a fixed sequence multiple-testing procedure as well as a Holm procedure. The testing utilized the sequence of hypothesis testing for the co-primary endpoints using two-sided α of 0.05 followed by a set of ranked key secondary endpoints, defined separately for US/FDA and EU/EMA regulatory purposes.|Adjusted Response Rate Difference|11.7||||0.0022|TWO_SIDED|95.0|4.2|19.2|||Cochran-Mantel-Haenszel|Cochran Mantel-Haenszel test adjusted for stratification factors.|Adjusted response rate difference (Upadacitinib - Placebo) calculated based on CMH test adjusted for stratification factors.|||19.2|4.2|0.0022
72525726|NCT03345849|144582229|SUPERIORITY|The overall type I error rate of the co-primary and ranked secondary endpoints were strongly controlled using a fixed sequence multiple-testing procedure as well as a Holm procedure. The testing utilized the sequence of hypothesis testing for the co-primary endpoints using two-sided α of 0.05 followed by a set of ranked key secondary endpoints, defined separately for US/FDA and EU/EMA regulatory purposes.|Adjusted Response Rate Difference|19.8|||<|0.0001|TWO_SIDED|95.0|11.3|28.4|||Cochran-Mantel-Haenszel|Cochran Mantel-Haenszel test adjusted for stratification factors.|Adjusted response rate difference (Upadacitinib - Placebo) calculated based on CMH test adjusted for stratification factors.|||28.4|11.3|<0.0001
72525727|NCT03345849|144582230|SUPERIORITY|The overall type I error rate of the co-primary and ranked secondary endpoints were strongly controlled using a fixed sequence multiple-testing procedure as well as a Holm procedure. The testing utilized the sequence of hypothesis testing for the co-primary endpoints using two-sided α of 0.05 followed by a set of ranked key secondary endpoints. This endpoint was a ranked key secondary endpoint for US/FDA regulatory purposes.|Adjusted Response Rate Difference|10.8||||0.0071|TWO_SIDED|95.0|2.9|18.6|||Cochran-Mantel-Haenszel|Cochran Mantel-Haenszel test adjusted for stratification factors.|Adjusted response rate difference (Upadacitinib - Placebo) calculated based on CMH test adjusted for stratification factors.|||18.6|2.9|0.0071
72525728|NCT03345849|144582231|SUPERIORITY|The overall type I error rate of the co-primary and ranked secondary endpoints were strongly controlled using a fixed sequence multiple-testing procedure as well as a Holm procedure. The testing utilized the sequence of hypothesis testing for the co-primary endpoints using two-sided α of 0.05 followed by a set of ranked key secondary endpoints, defined separately for US/FDA and EU/EMA regulatory purposes.|Response Rate Difference|-1.4||||0.4494|TWO_SIDED|95.0|-5.2|2.4|||Chi-squared||Response rate difference = Upadacitinib - Placebo|||2.4|-5.2|0.4494
72525729|NCT03345849|144582232|OTHER|The overall type I error rate of the co-primary and ranked secondary endpoints were strongly controlled using a fixed sequence multiple-testing procedure as well as a Holm procedure. The testing utilized the sequence of hypothesis testing for the co-primary endpoints using two-sided α of 0.05 followed by a set of ranked key secondary endpoints, defined separately for US/FDA and EU/EMA regulatory purposes.|Adjusted Response Rate Difference|9.0||||0.1044|TWO_SIDED|95.0|-1.9|19.9|||Cochran-Mantel-Haenszel|Cochran Mantel-Haenszel test adjusted for stratification factors.|Adjusted response rate difference (Upadacitinib - Placebo) calculated based on CMH test adjusted for stratification factors.|||19.9|-1.9|0.1044
72625285|NCT01098747|144780085|SUPERIORITY_OR_OTHER||Difference in proportion|69.53|||<|0.001|TWO_SIDED|95.0|57.67|81.4||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||0.5 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||81.40|57.67|<0.001
72625286|NCT01098747|144780085|SUPERIORITY_OR_OTHER||Difference in proportion|23.45|||<|0.001|TWO_SIDED|95.0|13.16|33.75||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||0.5 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||33.75|13.16|<0.001
72625287|NCT01098747|144780085|SUPERIORITY_OR_OTHER||Difference in proportion|73.72|||<|0.001|TWO_SIDED|95.0|62.77|84.67||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1 hour: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||84.67|62.77|<0.001
72625288|NCT01098747|144780085|SUPERIORITY_OR_OTHER||Difference in proportion|10.14||||0.014|TWO_SIDED|95.0|3.21|17.08||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1 hour: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||17.08|3.21|0.014
72625289|NCT01098747|144780085|SUPERIORITY_OR_OTHER||Difference in proportion|72.61|||<|0.001|TWO_SIDED|95.0|61.05|84.17||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1.5 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||84.17|61.05|<0.001
72406787|NCT04115358|144322115|SUPERIORITY||||||>|0.05|||||||Chi-squared|||Chi-Square Test was used to compare qualitative data.The results were evaluated at the significance level of p\<0,05.||||>0.05
72406788|NCT04115358|144322116|SUPERIORITY||||||>|0.05|||||||Chi-squared|||Chi-Square Test was used to compare qualitative data.The results were evaluated at the significance level of p\<0,05.||||>0.05
72406789|NCT04115358|144322117|SUPERIORITY||||||>|0.05|||||||Chi-squared|||Chi-Square Test was used to compare qualitative data.The results were evaluated at the significance level of p\<0,05.||||>0.05
72406790|NCT04115358|144322118|SUPERIORITY||||||>|0.05|||||||Chi-squared|||Chi-Square Test was used to compare qualitative data.The results were evaluated at the significance level of p\<0,05.||||>0.05
72406791|NCT04115358|144322119|SUPERIORITY||||||>|0.05|||||||Chi-squared|||Chi-Square Test was used to compare qualitative data.The results were evaluated at the significance level of p\<0,05.||||>0.05
72406792|NCT04115358|144322120|SUPERIORITY||||||>|0.05|||||||Chi-squared|||Chi-Square Test was used to compare qualitative data.The results were evaluated at the significance level of p\<0,05.||||>0.05
72406793|NCT04115358|144322121|SUPERIORITY||||||>|0.05|||||||Chi-squared|||Chi-Square Test was used to compare qualitative data.The results were evaluated at the significance level of p\<0,05.||||>0.05
72406794|NCT04115358|144322122|SUPERIORITY||||||>|0.05|||||||Chi-squared|||Chi-Square Test was used to compare qualitative data.The results were evaluated at the significance level of p\<0,05.||||>0.05
72406795|NCT04115358|144322123|SUPERIORITY||||||>|0.05|||||||Chi-squared|||Chi-Square Test was used to compare qualitative data.The results were evaluated at the significance level of p\<0,05.||||>0.05
72406796|NCT04115358|144322124|SUPERIORITY||||||>|0.05|||||||Chi-squared|||Chi-Square Test was used to compare qualitative data.The results were evaluated at the significance level of p\<0,05.||||>0.05
72525730|NCT03345849|144582233|SUPERIORITY|The overall type I error rate of the co-primary and ranked secondary endpoints were strongly controlled using a fixed sequence multiple-testing procedure as well as a Holm procedure. The testing utilized the sequence of hypothesis testing for the co-primary endpoints using two-sided α of 0.05 followed by a set of ranked key secondary endpoints. This endpoint was a ranked key secondary endpoint for EU/EMA regulatory purposes.|Adjusted Response Rate Difference|21.2|||<|0.0001|TWO_SIDED|95.0|14.3|28.2|||Cochran-Mantel-Haenszel|Cochran Mantel-Haenszel test adjusted for stratification factors.|Adjusted response rate difference (Upadacitinib - Placebo) calculated based on CMH test adjusted for stratification factors.|||28.2|14.3|<0.0001
72406797|NCT04115358|144322125|SUPERIORITY||||||>|0.05|||||||Chi-squared|||Chi-Square Test was used to compare qualitative data.The results were evaluated at the significance level of p\<0,05.||||>0.05
72525731|NCT03345849|144582234|SUPERIORITY|The overall type I error rate of the co-primary and ranked secondary endpoints were strongly controlled using a fixed sequence multiple-testing procedure as well as a Holm procedure. The testing utilized the sequence of hypothesis testing for the co-primary endpoints using two-sided α of 0.05 followed by a set of ranked key secondary endpoints. This endpoint was a ranked key secondary endpoint for EU/EMA regulatory purposes.|Adjusted Response Rate Difference|32.6|||<|0.0001|TWO_SIDED|95.0|21.5|43.7|||Cochran-Mantel-Haenszel|Cochran Mantel-Haenszel test adjusted for stratification factors.|Adjusted response rate difference (Upadacitinib - Placebo) calculated based on CMH test adjusted for stratification factors.|||43.7|21.5|<0.0001
72525732|NCT04437511|144582240|SUPERIORITY||LS Mean change difference (Final Values)|2.92|STANDARD_ERROR_OF_MEAN|0.72|<|0.001|TWO_SIDED|95.0|1.508|4.331|||Mixed Models Analysis|||||4.331|1.508|<0.001
72406798|NCT04115358|144322126|SUPERIORITY||||||>|0.05|||||||Chi-squared|||Chi-Square Test was used to compare qualitative data.The results were evaluated at the significance level of p\<0,05.||||>0.05
72406799|NCT04115358|144322127|SUPERIORITY||||||>|0.05|||||||Chi-squared|||Chi-Square Test was used to compare qualitative data.The results were evaluated at the significance level of p\<0,05.||||>0.05
72406800|NCT04115358|144322128|SUPERIORITY||||||>|0.05|||||||Chi-squared|||Chi-Square Test was used to compare qualitative data.The results were evaluated at the significance level of p\<0,05.||||>0.05
72406801|NCT04115358|144322129|SUPERIORITY||||||>|0.05|||||||Chi-squared|||Chi-Square Test was used to compare qualitative data.The results were evaluated at the significance level of p\<0,05.||||>0.05
72406802|NCT04115358|144322130|SUPERIORITY||||||>|0.05|||||||Chi-squared|||Chi-Square Test was used to compare qualitative data.The results were evaluated at the significance level of p\<0,05.||||>0.05
72406803|NCT04115358|144322131|SUPERIORITY||||||>|0.05|||||||Chi-squared|||Chi-Square Test was used to compare qualitative data.The results were evaluated at the significance level of p\<0,05.||||>0.05
72406804|NCT04115358|144322132|SUPERIORITY||||||>|0.05|||||||Chi-squared|||Chi-Square Test was used to compare qualitative data.The results were evaluated at the significance level of p\<0,05.||||>0.05
72406805|NCT04115358|144322133|SUPERIORITY||||||>|0.05|||||||Chi-squared|||Chi-Square Test was used to compare qualitative data.The results were evaluated at the significance level of p\<0,05.||||>0.05
72406806|NCT02115282|144322136|SUPERIORITY||Hazard Ratio (HR)|0.87||||0.3|TWO_SIDED|95.0|0.67|1.13||The p value was based on stratified log rank test, the threshold for significance was two-sided p value of 0.2%.|Log Rank|||||1.13|0.67|0.30
72406807|NCT02115282|144322137|SUPERIORITY||Hazard Ratio (HR)|0.99||||0.94|TWO_SIDED|95.0|0.82|1.21||The p value was based on stratified log rank test, stratified on the four randomization factors. The threshold for statistical significance was two-sided p value of 3.7% after taking into account the five interim analyses of OS into account.|Log Rank|||||1.21|0.82|0.94
72406808|NCT01686646|144322145|SUPERIORITY_OR_OTHER||LS Mean DIfference|3.5||||0.0248|TWO_SIDED|95.0|0.4|6.5||A hierarchical testing procedure was used such that p-values were only presented if the preceding treatment comparison was statistically significant (p\<0.05).|ANCOVA|From ANCOVA model with factors for treatment group and season, and baseline score as a covariate.|A positive difference favored the first named treatment.|Null hypothesis was no difference in treatments in the change from baseline in the number of valid responses from the RVIP.||6.5|0.4|0.0248
72406809|NCT01686646|144322145|SUPERIORITY_OR_OTHER||LS Mean Difference|1.7||||0.1513|TWO_SIDED|95.0|-0.6|4.1||A hierarchical testing procedure was used such that p-values were only presented if the preceding treatment comparison was statistically significant (p\<0.05).|ANCOVA|From ANCOVA model with factors for treatment group and season, and baseline score as a covariate.|A positive difference favoured the first named treatment.|Null hypothesis was no difference in treatments in the change from baseline in the number of valid responses from the RVIP.||4.1|-0.6|0.1513
72406810|NCT01686646|144322145|SUPERIORITY_OR_OTHER||LS Mean Difference|3.9|||||TWO_SIDED|95.0|1.1|6.6||Not significant based on hierarchical testing.|ANCOVA|From ANCOVA model with factors for treatment group and season, and baseline score as a covariate.|A positive difference favoured the first named treatment.|Null hypothesis was no difference in treatments in change from baseline in number of valid responses from RVIP task.||6.6|1.1|
72525733|NCT04437511|144582241|SUPERIORITY||LS Mean change difference (Final Values)|3.25|STANDARD_ERROR_OF_MEAN|0.7|<|0.001|TWO_SIDED|95.0|1.883|4.618|||Mixed Models Analysis|||||4.618|1.883|<0.001
72525734|NCT04437511|144582242|SUPERIORITY||LS Mean change difference (Final Values)|0.47|STANDARD_ERROR_OF_MEAN|0.19||0.012|TWO_SIDED|95.0|0.104|0.841|||Mixed Models Analysis|||||0.841|0.104|0.012
72525735|NCT04437511|144582243|SUPERIORITY||LS Mean change difference (Final Values)|0.48|STANDARD_ERROR_OF_MEAN|0.2||0.016|TWO_SIDED|95.0|0.089|0.868|||Mixed Models Analysis|||||0.868|0.089|0.016
72525736|NCT04437511|144582244|SUPERIORITY||LS Mean change difference (Final Values)|-1.33|STANDARD_ERROR_OF_MEAN|0.39||0.0006|TWO_SIDED|95.0|-2.086|-0.565|||Mixed Models Analysis|||||-0.565|-2.086|0.0006
72525737|NCT04437511|144582245|SUPERIORITY||LS Mean change difference (Final Values)|-1.52|STANDARD_ERROR_OF_MEAN|0.37|<|0.001|TWO_SIDED|95.0|-2.25|-0.794|||Mixed Models Analysis|||||-0.794|-2.250|<0.001
72525738|NCT04437511|144582246|SUPERIORITY||LS Mean change difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|0.127|<|0.001|TWO_SIDED|95.0|-0.95|-0.45|||Mixed Models Analysis|||||-0.45|-0.95|<0.001
72525739|NCT04437511|144582247|SUPERIORITY||LS Mean change difference (Final Values)|-0.67|STANDARD_ERROR_OF_MEAN|0.141|<|0.001|TWO_SIDED|95.0|-0.95|-0.4|||Mixed Models Analysis|||||-0.40|-0.95|<0.001
72525740|NCT04437511|144582248|SUPERIORITY||LS Mean change difference (Final Values)|1.7|STANDARD_ERROR_OF_MEAN|0.44||0.0001|TWO_SIDED|95.0|0.84|2.566|||Mixed Models Analysis|||||2.566|0.840|0.0001
72525741|NCT04437511|144582249|SUPERIORITY||LS Mean change difference (Final Values)|1.83|STANDARD_ERROR_OF_MEAN|0.47|<|0.001|TWO_SIDED|95.0|0.913|2.748|||Mixed Models Analysis|||||2.748|0.913|<0.001
72525742|NCT04437511|144582250|SUPERIORITY||LS Mean change difference (Final Values)|-86.37|STANDARD_ERROR_OF_MEAN|1.275|<|0.0001|TWO_SIDED|95.0|-88.87|-83.87|||Mixed Models Analysis|||||-83.87|-88.87|<0.0001
72525743|NCT04437511|144582251|SUPERIORITY||LS Mean change difference (Final Values)|-0.0041||||0.4522|TWO_SIDED|95.0|-0.0148|0.0066|||ANCOVA|||||0.0066|-0.0148|0.4522
72525744|NCT04437511|144582252|SUPERIORITY||LS Mean change difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.007||0.002|TWO_SIDED|95.0|0.01|0.04|||Mixed Models Analysis|||Bilateral Hippocampus||0.04|0.01|0.002
72525745|NCT04437511|144582252|SUPERIORITY||LS Mean change difference (Final Values)|-6.66|STANDARD_ERROR_OF_MEAN|0.561|<|0.001|TWO_SIDED|95.0|-7.76|-5.56|||Mixed Models Analysis|||Bilateral Whole Brain||-5.56|-7.76|<0.001
72525746|NCT04437511|144582252|SUPERIORITY||LS Mean change difference (Final Values)|3.02|STANDARD_ERROR_OF_MEAN|0.256|<|0.001|TWO_SIDED|95.0|2.52|3.52|||Mixed Models Analysis|||Bilateral Ventricles||3.52|2.52|<0.001
72525747|NCT05306964|144582281|OTHER|||||||0.5|||||||GLMM|||||||0.5
72525748|NCT05306964|144582282|OTHER|||||||0.4|||||||GLMM|||||||0.4
72525749|NCT05306964|144582283|OTHER|||||||0.5|||||||GLMM|||||||0.5
72525750|NCT05306964|144582284|OTHER|||||||0.3|||||||GLMM|||||||0.3
72525751|NCT05306964|144582285|OTHER|||||||0.4|||||||GLMM|||||||0.4
72525752|NCT05306964|144582286|OTHER|||||||0.5|||||||GLMM|||||||0.5
72525753|NCT05306964|144582287|OTHER|||||||0.3|||||||GLMM|||||||0.3
72525754|NCT05306964|144582288|OTHER|||||||0.3|||||||GLMM|||||||0.3
72525755|NCT05306964|144582289|OTHER|||||||0.7|||||||GLMM|||||||0.7
72525756|NCT05306964|144582290|OTHER|||||||0.2|||||||GLMM|||||||0.2
72525757|NCT05306964|144582291|OTHER|||||||0.02|||||||GLMM|||||||0.02
72525758|NCT05306964|144582292|OTHER|||||||0.2|||||||GLMM|||||||0.2
72525759|NCT05306964|144582293|OTHER|||||||0.7|||||||GLMM|||||||0.7
72525760|NCT05306964|144582294|OTHER|||||||0.1|||||||GLMM|||||||0.1
72525761|NCT05306964|144582295|OTHER|||||||0.2|||||||GLMM|||||||0.2
72525762|NCT05306964|144582296|OTHER||||||<|0.001|||||||GLMM|||||||<0.001
72525763|NCT05306964|144582297|OTHER|||||||0|||||||GLMM|||||||0
72525764|NCT05306964|144582298|OTHER|||||||0.5|||||||GLMM|||||||0.5
72525765|NCT05306964|144582299|OTHER|||||||0.9|||||||GLMM|||||||0.9
72525766|NCT05306964|144582300|OTHER|||||||0.8|||||||GLMM|||||||0.8
72525767|NCT05306964|144582301|OTHER|||||||0|||||||GLMM|||||||0
72525768|NCT05306964|144582302|OTHER|||||||0|||||||GLMM|||||||0
72525769|NCT05306964|144582303|OTHER|||||||0.2|||||||GLMM|||||||0.2
72525770|NCT05306964|144582304|OTHER|||||||0|||||||GLMM|||||||0
72525771|NCT05306964|144582305|OTHER|||||||0.9|||||||GLMM|||||||0.9
72525772|NCT05306964|144582306|OTHER|||||||0|||||||GLMM|||||||0
72525773|NCT05306964|144582307|OTHER|||||||0.9|||||||GLMM|||||||0.9
72525774|NCT05306964|144582308|OTHER|||||||0|||||||GLMM|||||||0
72525775|NCT05306964|144582309|OTHER|||||||0|||||||GLMM|||||||0
72525776|NCT05306964|144582310|OTHER|||||||0|||||||GLMM|||||||0
72525777|NCT05306964|144582311|OTHER|||||||0.5|||||||GLMM|||||||0.5
72525778|NCT05306964|144582312|OTHER|||||||0.2|||||||GLMM|||||||0.2
72525779|NCT05306964|144582313|OTHER|||||||0.3|||||||GLMM|||||||0.3
72525780|NCT03811535|144582354|NON_INFERIORITY|The pre-specified non-inferiority margin was -1.8 cm/year.|Treatment difference|-0.5|||||TWO_SIDED|95.0|-1.1|0.2|||ANCOVA|||Height velocity at week 52 was analyzed using an analysis of covariance model with treatment, gender, age group, region, growth hormone (GH) peak group and gender by age group by region interaction term as factors, and baseline height as covariate.||0.2|-1.1|
72525781|NCT03811535|144582355|NON_INFERIORITY|The pre-specified non-inferiority margin was -1.8 cm/year.|Treatment difference|-0.5|||||TWO_SIDED|95.0|-1.1|0.2|||Mixed Models Analysis|||Height velocity at 52 weeks was analyzed using a mixed model for repeated measurements, with treatment, gender, age group, region, GH peak group and gender by age group by region interaction terms as factors and baseline height as a covariate, all nested within week as a factor.||0.2|-1.1|
72525782|NCT05564039|144582383|SUPERIORITY||LS Mean difference (Final Values)|-0.9|||<|0.0001|TWO_SIDED|95.0|-1.1|-0.69|||Mixed Models Analysis|||||-0.69|-1.10|<0.0001
72525783|NCT05564039|144582384|SUPERIORITY||LS Mean difference (Final Values)|-7.4|||<|0.0001|TWO_SIDED|95.0|-8.7|-6.0|||Mixed Models Analysis|||||-6.0|-8.7|<.0001
72525784|NCT05564039|144582385|SUPERIORITY||Odds Ratio (OR)|7.13|||<|0.0001|TWO_SIDED|95.0|3.82|13.32|||Regression, Logistic|||||13.32|3.82|<0.0001
72525785|NCT05564039|144582386|SUPERIORITY||Odds Ratio (OR)|12.24|||<|0.0001|TWO_SIDED|95.0|6.51|23.02|||Regression, Logistic|||||23.02|6.51|<0.0001
72406811|NCT01686646|144322146|SUPERIORITY_OR_OTHER||LS Mean Difference|2.9||||0.0696|TWO_SIDED|95.0|-0.2|6.1||A hierarchical testing procedure was used such that p-values were only presented if the preceding treatment comparison was statistically significant (p\<0.05).|ANCOVA|From ANCOVA model with factors for treatment group and season, and baseline score as a covariate.|A positive difference favored the first named treatment.|Null hypothesis was no difference in treatments in the change from baseline in the number of accurate responses from the RVIP.||6.1|-0.2|0.0696
72406812|NCT01686646|144322146|SUPERIORITY_OR_OTHER||LS Mean Difference|2.7|||||TWO_SIDED|95.0|0.3|5.2||A hierarchical testing procedure was used such that p-values were only presented if the preceding treatment comparison was statistically significant (p\<0.05).|ANCOVA|From ANCOVA model with factors for treatment group and season, and baseline score as a covariate.|A positive difference favored the first named treatment.|Null hypothesis was no difference in treatments in the change from baseline in the number of valid responses from the RVIP.||5.2|0.3|
72406813|NCT01686646|144322146|SUPERIORITY_OR_OTHER||LS Mean Difference|1.1|||||TWO_SIDED|95.0|-1.7|3.9||A hierarchical testing procedure was used such that p-values were only presented if the preceding treatment comparison was statistically significant (p\<0.05).|ANCOVA|From ANCOVA model with factors for treatment group and season, and baseline score as a covariate.|A positive difference favored the first named treatment.|Null hypothesis was no difference in treatments in the change from baseline in the number of valid responses from the RVIP.||3.9|-1.7|
72406814|NCT00556842|144322156|EQUIVALENCE|Please refer to the protocol paper for details of the power calculation.|Mean Difference (Final Values)|-6.37|||||TWO_SIDED|99.0|-9.18|-3.56||||||Using a multi-level model, the effect of THA versus HA on function (WOMAC) was estimated. We chose an alpha level of 0.01. The results below are the mean difference in score for WOMAC total at 24 months.||-3.56|-9.18|
72406815|NCT00556842|144322156|EQUIVALENCE|Please refer to the protocol paper for details of the power calculation.|Mean Difference (Final Values)|-0.93|||||TWO_SIDED|99.0|-1.42|-0.44||||||Using a multi-level model, the effect of THA versus HA on function (WOMAC) was estimated. We chose an alpha level of 0.01. The results below are the mean difference in score for WOMAC pain at 24 months.||-0.44|-1.42|
72406816|NCT00556842|144322156|EQUIVALENCE|Please refer to the protocol paper for details of the power calculation.|Mean Difference (Final Values)|-0.44|||||TWO_SIDED|99.0|-0.65|-0.23||||||Using a multi-level model, the effect of THA versus HA on function (WOMAC) was estimated. We chose an alpha level of 0.01. The results below are the mean difference in score for WOMAC stiffness at 24 months.||-0.23|-0.65|
72406817|NCT00556842|144322156|EQUIVALENCE|Please refer to the protocol paper for details of the power calculation.|Mean Difference (Final Values)|-4.97|||||TWO_SIDED|99.0|-7.11|-2.83||||||Using a multi-level model, the effect of THA versus HA on function (WOMAC) was estimated. We chose an alpha level of 0.01. The results below are the mean difference in score for WOMAC function at 24 months.||-2.83|-7.11|
72525786|NCT05564039|144582387|SUPERIORITY||Odds Ratio (OR)|15.34|||<|0.0001|TWO_SIDED|95.0|4.58|51.36|||Regression, Logistic|||||51.36|4.58|<0.0001
72525787|NCT05564039|144582388|SUPERIORITY||Odds Ratio (OR)|9.31|||<|0.0001|TWO_SIDED|95.0|5.11|16.98|||Regression, Logistic|||||16.98|5.11|<0.0001
72406818|NCT00556842|144322157|EQUIVALENCE|Please refer to the protocol paper for details of the power calculation.|Odds Ratio (OR)|0.72|||||TWO_SIDED|99.0|0.38|1.36||||||Using a multi-level model, the effect of THA versus HA on mobility (TUG) was estimated. We analyzed the TUG as a dichotomous outcome with the following categories: a) patients who complete the test in ≤12 seconds, and b) those who require \>12 seconds to complete the test or were unable to complete the test. We selected 12 seconds as the cut-off because this was the threshold used by the Centers for Disease Control and Prevention. The TUG was summarized using odds ratios and 99% CIs.||1.36|0.38|
72525788|NCT05564039|144582389|SUPERIORITY||Odds Ratio (OR)|19.35|||<|0.0001|TWO_SIDED|95.0|9.07|41.3|||Regression, Logistic|||||41.30|9.07|<0.0001
72525789|NCT05564039|144582390|SUPERIORITY||Odds Ratio (OR)|35.83|||<|0.0001|TWO_SIDED|95.0|7.18|178.89|||Regression, Logistic|||||178.89|7.18|<0.0001
72406819|NCT00556842|144322158|EQUIVALENCE|Please refer to the protocol paper for details of the power calculation.|Mean Difference (Final Values)|1.41|||||TWO_SIDED|99.0|-0.33|3.14||||||Using a multi-level model, the effect of THA versus HA on quality of life (SF-12) was estimated. We chose an alpha level of 0.01. The results below are the mean difference in score for SF-12 PCS at 24 months.||3.14|-0.33|
72525790|NCT05564039|144582391|SUPERIORITY||Odds Ratio (OR)|20.44|||<|0.0001|TWO_SIDED|95.0|8.4|49.77|||Regression, Logistic|||||49.77|8.40|<0.0001
72525791|NCT05564039|144582392|SUPERIORITY||LS Mean difference (Final Values)|-0.9|||<|0.001|TWO_SIDED|95.0|-1.32|-0.49|||ANCOVA|||||-0.49|-1.32|<0.001
72525792|NCT05564039|144582393|SUPERIORITY||LS Mean difference (Final Values)|-5.1||||0.0002|TWO_SIDED|95.0|-7.8|-2.5|||Mixed Models Analysis|||||-2.5|-7.8|0.0002
72525793|NCT05564039|144582394|SUPERIORITY||LS Mean difference (Final Values)|-2.6|||<|0.0001|TWO_SIDED|95.0|-3.1|-2.1|||Mixed Models Analysis|||||-2.1|-3.1|<0.0001
72525794|NCT05564039|144582395|SUPERIORITY||LS Mean difference (Final Values)|4.1||||0.1181|TWO_SIDED|95.0|-1.0|9.2|||ANCOVA|||||9.2|-1.0|0.1181
72525795|NCT04453722|144582428|SUPERIORITY|Median difference was estimated from the Hodges-Lehmann estimator of location shift between groups and p-values from Wilcoxon rank sum test.|Median Difference (Final Values)|-0.1||||0.12|TWO_SIDED|95.0|-0.4|0.0|||Wilcoxon (Mann-Whitney)|||variable: In hospital TWA SpO2 \<90% (%)||0|-0.4|0.120
72525796|NCT04453722|144582428|SUPERIORITY|Median difference was estimated from the Hodges-Lehmann estimator of location shift between groups and p-values from Wilcoxon rank sum test|Median Difference (Final Values)|-407.0||||0.349|TWO_SIDED|95.0|-1816.0|208.0|||Wilcoxon (Mann-Whitney)|||variable: In hospital AUC SpO2 \<90% (% \* min)||208|-1816|0.349
72525797|NCT04453722|144582428|SUPERIORITY|Median difference was estimated from the Hodges-Lehmann estimator of location shift between groups and p-values from Wilcoxon rank sum test.|Median Difference (Final Values)|-0.1||||0.307|TWO_SIDED|95.0|-0.2|0.0|||Wilcoxon (Mann-Whitney)|||variable: Post-discharge TWA SpO2 \<90% (%)||0|-0.2|0.307
72571226|NCT04536935|144670952|SUPERIORITY|A series of mixed effects models using restricted maximum likelihood estimation were built to test linear time change on the PHQ-9 and to test for condition differences at follow-up and change slope. Models were built in an outwardly nested fashion, such that an initial null model was computed, followed by models that added a random intercept, random time component, condition assignment, and condition x time interaction effects.|Slope|-1.5|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|-1.8|-1.1|||Mixed Models Analysis|||||-1.1|-1.8|<.001
72571227|NCT04536935|144670953|OTHER|A series of mixed effects models using restricted maximum likelihood estimation were built to test linear time change on the GAD-7 and to test for condition differences at follow-up and change slope. Models were built in an outwardly nested fashion, such that an initial null model was computed, followed by models that added a random intercept, random time component, condition assignment, and condition x time interaction effects.|Slope|-1.3|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|-1.6|-1.0|||Mixed Models Analysis|||||-1.0|-1.6|<.001
72571228|NCT04536935|144670954|OTHER|A series of mixed effects models using restricted maximum likelihood estimation were built to test linear time change on the DERS and to test for condition differences at follow-up and change slope. Models were built in an outwardly nested fashion, such that an initial null model was computed, followed by models that added a random intercept, random time component, condition assignment, and condition x time interaction effects.||||||0.73|||||||Mixed Models Analysis|||||||.73
72571229|NCT04536935|144670955|OTHER|||||||0.25|||||||Mixed Models Analysis|||||||.25
72571230|NCT04536935|144670956|SUPERIORITY|||||||0.22|||||||ANOVA|||||||.22
72571231|NCT04536935|144670957|SUPERIORITY|||||||0.48|||||||ANOVA|||||||.48
72571232|NCT04536935|144670958|SUPERIORITY||||||<|0.0001|||||||ANOVA|||||||<.0001
72571233|NCT02731326|144670980|EQUIVALENCE|The study was designed to have 80% power to detect a hazard ratio of 2 for recurrence detection (α = .05).|Hazard Ratio (HR)|1.56||||0.05|TWO_SIDED|95.0|1.06|2.3|||Regression, Cox||Treatment arm equals numerator. Control arm=denominator.|The study was designed to have 80% power to detect a hazard ratio of 2 for recurrence detection (α = .05). Kaplan-Meier curves were created for recurrence detection in the intervention and control groups over the 6-month follow-up period. Differences in time to recurrence between groups were assessed using a Cox proportional hazards model. Baseline variables that differed significantly between groups were included as covariates and adjusted Kaplan-Meier curves were constructed.||2.30|1.06|0.05
72571234|NCT02731326|144670981|EQUIVALENCE|The study was designed to have 80% power to detect a hazard ratio of 2 (α = .05).|Hazard Ratio (HR)|0.33||||0.05|TWO_SIDED|95.0|0.09|0.58|||Regression, Cox||Treatment arm equals numerator. Control arm=denominator.|Kaplan-Meier curves were created for assessing time to treatment for intervention and control groups. Time to treatment was defined as the time interval from detection of a recurrent arrhythmia to treatment for that arrhythmia.||0.58|0.09|0.05
72571235|NCT02731326|144670982|SUPERIORITY||Hazard Ratio (HR)|0.33|||<|0.0001|TWO_SIDED|95.0|0.19|0.58|||Regression, Cox|||||0.58|0.19|<.0001
72571236|NCT02731326|144670983|SUPERIORITY|||||||0.24|||||||t-test, 2 sided|||||||0.24
72571237|NCT02731326|144670984|SUPERIORITY|||||||0.89|||||||t-test, 2 sided|||||||0.89
72571238|NCT00302081|144671017|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority for SVR was concluded if the lower limit of the one-sided 95% CI was greater than -10%. Otherwise, noninferiority was concluded for both dose and treatment duration comparisons if the lower limits of the two-sided 95% CIs were greater than -10%.|Risk Difference (RD)|-0.02||||0.041||95.0|-0.1|1.0||The Hochberg procedure was used to adjust for the multiple comparisons (\[PEG2b 1.0/R(24 weeks)\] - \[PEG2b 1.5/R(24 weeks\]) and (\[PEG2b 1.5/R(16 weeks)\]-\[PEG2b 1.5/R(24 weeks)\]).|z-test (non-inferiority margin=-0.1)|SVR rates are 0.665 (153/230 subjects) in the 1.5-dose group and 0.643 (144/224 subjects) in the 1.0-dose group, for a risk difference of -0.02.||This is an evaluation of the effect of the peginterferon alfa-2b dose (1.0 vs 1.5 micrograms/kg/week) on the primary outcome measure.||1|-0.10|0.041
72571239|NCT00302081|144671017|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority for SVR was concluded if the lower limit of the one-sided 95% CI was greater than -10%. Otherwise, noninferiority was concluded for both dose and treatment duration comparisons if the lower limits of the two-sided 95% CIs were greater than -10%.|Risk Difference (RD)|-0.1||||0.495||95.0|-0.17|1.0||The Hochberg procedure was used to adjust for the multiple comparisons (\[PEG2b 1.0/R(24 weeks)\] - \[PEG2b 1.5/R(24 weeks\]) and (\[PEG2b 1.5/R(16 weeks\]-\[PEG2b 1.5/R(24 weeks\]).|z-test (non-inferiority margin=-0.1)|SVR rates are 0.665 (153/230 subjects) in the 24-week group and 0.566 (129/228 subjects) in the 16-week group, for a risk difference of -0.10.||This is an evaluation of the effect of treatment duration (24 weeks vs 16 weeks) on the primary outcome measure.||1|-0.17|0.495
72571240|NCT01986010|144671091|OTHER||GMT Ratio|1.5|||||TWO_SIDED|95.0|0.8|2.6||||||GMT Ratio: GMT V160/GMT placebo||2.6|0.8|
72571241|NCT01986010|144671091|OTHER||GMT Ratio|1.9|||||TWO_SIDED|95.0|1.1|3.2||||||GMT Ratio: GMT V160/GMT placebo||3.2|1.1|
72571242|NCT01986010|144671091|OTHER||GMT Ratio|3.5|||||TWO_SIDED|95.0|1.6|7.4||||||GMT Ratio: GMT V160/GMT placebo||7.4|1.6|
72571243|NCT01986010|144671091|OTHER||GMT Ratio|2.6|||||TWO_SIDED|95.0|1.4|4.6||||||GMT Ratio: GMT V160/GMT placebo||4.6|1.4|
72571244|NCT01986010|144671091|OTHER||GMT Ratio|1.6|||||TWO_SIDED|95.0|0.9|3.0||||||GMT Ratio: GMT V160/GMT placebo||3.0|0.9|
72571245|NCT01986010|144671091|OTHER||GMT Ratio|3.9|||||TWO_SIDED|95.0|2.2|7.0||||||GMT Ratio: GMT V160/GMT placebo||7.0|2.2|
72571246|NCT01986010|144671091|OTHER||GMT Ratio|16.4|||<|0.001|TWO_SIDED|95.0|9.5|28.4||Hypothesis is GMT Ratio \>1|Two sample t-test|||GMT Ratio: GMT V160/GMT placebo||28.4|9.5|<0.001
72571247|NCT01986010|144671091|OTHER||GMT Ratio|76.6|||<|0.001|TWO_SIDED|95.0|49.5|118.6||Hypothesis is GMT Ratio \>1|Two sample t-test|||GMT Ratio: GMT V160/GMT placebo||118.6|49.5|<0.001
72571248|NCT01986010|144671091|OTHER||GMT Ratio|68.1|||<|0.001|TWO_SIDED|95.0|40.1|115.6||Hypothesis is GMT Ratio \>1|Two sample t-test|||GMT Ratio: GMT V160/GMT placebo||115.6|40.1|<0.001
72571249|NCT01986010|144671091|OTHER||GMT Ratio|41.0|||<|0.001|TWO_SIDED|95.0|23.8|70.7||Hypothesis is GMT Ratio \>1|Two sample t-test|||GMT Ratio: GMT V160/GMT placebo||70.7|23.8|<0.001
72571250|NCT01986010|144671091|OTHER||GMT Ratio|128.6|||<|0.001|TWO_SIDED|95.0|87.0|190.3||Hypothesis is GMT Ratio \>1|Two sample t-test|||GMT Ratio: GMT V160/GMT placebo||190.3|87.0|<0.001
72571251|NCT01986010|144671091|OTHER||GMT Ratio|62.0|||<|0.001|TWO_SIDED|95.0|30.5|126.1||Hypothesis is GMT Ratio \>1|Two sample t-test|||GMT Ratio: GMT V160/GMT placebo||126.1|30.5|<0.001
72406820|NCT00556842|144322158|EQUIVALENCE|Please refer to the protocol paper for details of the power calculation.|Mean Difference (Final Values)|1.34|||||TWO_SIDED|99.0|-0.38|3.05||||||Using a multi-level model, the effect of THA versus HA on quality of life (SF-12) was estimated. We chose an alpha level of 0.01. The results below are the mean difference in score for SF-12 MCS at 24 months.||3.05|-0.38|
72406821|NCT00556842|144322159|EQUIVALENCE|Please refer to the protocol paper for details of the power calculation.|Mean Difference (Final Values)|0.04|||||TWO_SIDED|99.0|-0.03|0.11||||||Using a multi-level model, the effect of THA versus HA on quality of life (EQ-5D) was estimated. We chose an alpha level of 0.01. The results below are the mean difference in score for EQ-5D utility index at 24 months.||0.11|-0.03|
72406822|NCT00556842|144322159|EQUIVALENCE|Please refer to the protocol paper for details of the power calculation.|Mean Difference (Final Values)|0.72|||||TWO_SIDED|99.0|-2.02|3.46||||||Using a multi-level model, the effect of THA versus HA on quality of life (EQ-5D) was estimated. We chose an alpha level of 0.01. The results below are the mean difference in score for EQ-5D VAS at 24 months.||3.46|-2.02|
72406823|NCT01723228|144322161|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|0.8||||0.2204|TWO_SIDED|95.0|-0.48|2.05|||repeated measures model|The statistical model is a repeated measures model with visit by treatment interaction, center, baseline score, and age as fixed effects.||||2.05|-0.48|0.2204
72406824|NCT01723228|144322162|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.1||||0.8428|TWO_SIDED|95.0|-0.99|0.81|||Repeated Measures Model|The statistical model is a repeated measures model with visit by treatment interaction, center, baseline score, and age as fixed effects.||||0.81|-0.99|0.8428
72406825|NCT01723228|144322163|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.7||||0.4796|TWO_SIDED|95.0|-2.74|1.3|||ANCOVA|The statistical model is an analysis of covariance (ANCOVA) with treatment, center, baseline score, and age as fixed effects.||||1.30|-2.74|0.4796
72406826|NCT01723228|144322164|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.61||||0.1148|TWO_SIDED|95.0|0.89|2.93|||Proportional Odds Model|The statistical model is a proportional odds model with terms for treatment, center, and age.||CGIC||2.93|0.89|0.1148
72406827|NCT01723228|144322164|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1052|TWO_SIDED||||||Cochran-Mantel-Haenszel|For the Cochran-Mantel-Haenszel (CMH) p-value, the statistical model is a CMH test controlling for center with scores=modridit option.||CGIC||||0.1052
72406828|NCT01723228|144322164|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.96||||0.8857|TWO_SIDED|95.0|0.52|1.75|||Proportional Odds Model|The statistical model is a proportional odds model with terms for treatment, center, and age.||CGIC Cognition||1.75|0.52|0.8857
72406829|NCT01723228|144322164|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9945|TWO_SIDED|||||For the CMH p-value, the statistical model is a CMH test controlling for center with scores=modridit option.|Cochran-Mantel-Haenszel|||CGIC Cognition||||0.9945
72406830|NCT01723228|144322164|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.16||||0.6909|TWO_SIDED|95.0|0.56|2.43|||Proportional Odds Model|The statistical model is a proportional odds model with terms for treatment, center, and age.||CGIC Behavior||2.43|0.56|0.6909
72406831|NCT01723228|144322164|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6639|TWO_SIDED||||||Cochran-Mantel-Haenszel|For the CMH p-value, the statistical model is a CMH test controlling for center with scores=modridit option.||CGIC Behavior||||0.6639
72406832|NCT01723228|144322164|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.39||||0.3204|TWO_SIDED|95.0|0.72|2.68|||Proportional Odds Model|The statistical model is a proportional odds model with terms for treatment, center, and age.||CGIC Functional Abilities||2.68|0.72|0.3204
72406833|NCT01723228|144322164|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3331|TWO_SIDED||||||Cochran-Mantel-Haenszel|For the CMH p-value, the statistical model is a CMH test controlling for center with scores=modridit option.||CGIC Functional Abilities||||0.3331
72625290|NCT01098747|144780085|SUPERIORITY_OR_OTHER||Difference in proportion|8.35||||0.028|TWO_SIDED|95.0|2.02|14.68||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1.5 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||14.68|2.02|0.028
72406834|NCT01723228|144322165|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-2.5||||0.0151|TWO_SIDED|95.0|-4.47|-0.49|||Repeated Measures Model|The statistical model is a repeated measures model with visit by treatment interaction, center, baseline score, and age as fixed effects.||||-0.49|-4.47|0.0151
72525798|NCT04453722|144582428|SUPERIORITY|Median difference was estimated from the Hodges-Lehmann estimator of location shift between groups and p-values from Wilcoxon rank sum test.|Median Difference (Final Values)|-35.0||||0.431|TWO_SIDED|95.0|-195.0|67.0|||Wilcoxon (Mann-Whitney)|||variable: Post-discharge AUC SpO2 \<90% (% \* min)||67|-195|0.431
72406835|NCT01723228|144322166|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-2.3||||0.0003|TWO_SIDED|95.0|-3.53|-1.08|||Repeated Measures Model|The statistical model is a repeated measures model with visit by treatment interaction, center, baseline score, and age as fixed effects.||||-1.08|-3.53|0.0003
72406836|NCT03091192|144322259|SUPERIORITY||Hazard Ratio (HR)|0.71||||0.313|TWO_SIDED|95.0|0.37|1.36|||Log Rank|||||1.36|0.37|0.313
72406837|NCT03091192|144322260|SUPERIORITY||Hazard Ratio (HR)|0.51||||0.11|TWO_SIDED|95.0|0.21|1.17|||Log Rank||A hazard ratio \< 1 favours Savolitinib|||1.17|0.21|0.110
72406838|NCT02533921|144322265|SUPERIORITY||Mean Difference (Final Values)|1.5022|STANDARD_ERROR_OF_MEAN|0.6749||0.0272|TWO_SIDED|95.0|0.1706|2.8338|||Mixed Models Analysis||Compares the palliative care plus usual care group to the usual care group.|Comparing the mean within group change from baseline to 6 months between groups. The null hypothesis is there is no mean difference between groups.||2.8338|0.1706|0.0272
72406839|NCT02533921|144322266|SUPERIORITY||Mean Difference (Final Values)|-1.1236|STANDARD_ERROR_OF_MEAN|0.8267||0.1761|TWO_SIDED|95.0|-2.7569|0.5097|||Mixed Models Analysis||Compares the palliative care plus usual care group to the usual care group.|Comparing the mean within group change from baseline to 6 months between groups. The null hypothesis is there is no mean difference between groups.||0.5097|-2.7569|0.1761
72525799|NCT04453722|144582429|SUPERIORITY||Risk Ratio (RR)|0.96|||>|0.99|TWO_SIDED|95.0|0.22|4.27|||Fisher Exact|||variable: In hospital Any event, N (%)c||4.27|0.22|>0.99
72525800|NCT04453722|144582429|SUPERIORITY||Risk Ratio (RR)|1.0|||>|0.99|TWO_SIDED|95.0|0.35|2.9|||Chi-squared|||variable: Post-discharge Any event, N (%)||2.90|0.35|>0.99
72525801|NCT04453722|144582430|SUPERIORITY|Median difference was estimated from the Hodges-Lehmann estimator of location shift between groups and p-values from Wilcoxon rank sum test.|Median Difference (Final Values)|-6.0||||0.354|TWO_SIDED|95.0|-26.0|4.0|||Wilcoxon (Mann-Whitney)|||variable: In hospital Number||4.0|-26.0|0.354
72525802|NCT04453722|144582430|SUPERIORITY|Median difference was estimated from the Hodges-Lehmann estimator of location shift between groups and p-values from Wilcoxon rank sum test.|Median Difference (Final Values)|-46.1||||0.133|TWO_SIDED|95.0|-274.0|5.1|||Wilcoxon (Mann-Whitney)|||variable: In hospital Total duration (min)||5.1|-274|0.133
72525803|NCT04453722|144582430|SUPERIORITY||Median Difference (Final Values)|-24.1||||0.075|TWO_SIDED|95.0|-213.0|0.1|||Wilcoxon (Mann-Whitney)|||variable: In hospital Duration \>2 min (min)||0.1|-213|0.075
72525804|NCT04453722|144582430|SUPERIORITY||Median Difference (Final Values)|-2.0||||0.009|TWO_SIDED|95.0|-4.5|-0.4|||Wilcoxon (Mann-Whitney)|||variable: In hospital Mean duration-all patients (min)||-0.4|-4.5|0.009
72525805|NCT04453722|144582430|SUPERIORITY||Median Difference (Final Values)|-2.2||||0.001|TWO_SIDED|95.0|-4.7|-0.7|||Wilcoxon (Mann-Whitney)|||variable: in hospital mean duration for events in those with any events (min)||-0.7|-4.7|0.001
72525806|NCT04453722|144582430|SUPERIORITY||Median Difference (Final Values)|0.0||||0.584|TWO_SIDED|95.0|-4.0|1.0|||Wilcoxon (Mann-Whitney)|||variable: post-discharge number||1.0|-4.0|0.584
72525807|NCT04453722|144582430|SUPERIORITY|Median difference was estimated from the Hodges-Lehmann estimator of location shift between groups and p-values from Wilcoxon rank sum test.|Median Difference (Final Values)|-1.3||||0.556|TWO_SIDED|95.0|-18.6|3.3|||Wilcoxon (Mann-Whitney)|||variable: Post-discharge duration (min)||3.3|-18.6|0.556
72525808|NCT04453722|144582433|SUPERIORITY|Median difference was estimated from the Hodges-Lehmann estimator of location shift between groups and P values from Wilcoxon rank sum test|Median Difference (Final Values)|1.0||||0.096|TWO_SIDED|95.0|0.0|2.0|||Wilcoxon (Mann-Whitney)|||variable: Degree of disturbing daily life except sleep (at the day of discharge)||2.0|0.0|0.096
72525809|NCT04453722|144582433|SUPERIORITY|Median difference was estimated from the Hodges-Lehmann estimator of location shift between groups and P values from Wilcoxon rank sum test|Median Difference (Final Values)|0.0||||0.205|TWO_SIDED|95.0|0.0|2.0|||Wilcoxon (Mann-Whitney)|||variable: Degree of disturbing sleep (at the day of discharge)||2.0|0.0|0.205
72525810|NCT04453722|144582433|SUPERIORITY|Median difference was estimated from the Hodges-Lehmann estimator of location shift between groups and P values from Wilcoxon rank sum test|Median Difference (Final Values)|0.0||||0.839|TWO_SIDED|95.0|-1.0|0.0|||Wilcoxon (Mann-Whitney)|||variable: comfortable to wear (at the day of discharge)||0.0|-1.0|0.839
72525811|NCT04453722|144582433|SUPERIORITY|Median difference was estimated from the Hodges-Lehmann estimator of location shift between groups and P values from Wilcoxon rank sum test|Median Difference (Final Values)|0.0||||0.621|TWO_SIDED|95.0|0.0|0.0|||Wilcoxon (Mann-Whitney)|||variable: Tolerable to audible alert (at the day of discharge)||0.0|0.0|0.621
72525812|NCT04453722|144582433|SUPERIORITY|Median difference was estimated from the Hodges-Lehmann estimator of location shift between groups and P values from Wilcoxon rank sum test|Median Difference (Final Values)|0.0||||0.898|TWO_SIDED|95.0|-1.0|1.0|||Wilcoxon (Mann-Whitney)|||variable: Tolerable to tactile alert||1.0|-1.0|0.898
72525813|NCT04453722|144582433|SUPERIORITY|Median difference was estimated from the Hodges-Lehmann estimator of location shift between groups and P values from Wilcoxon rank sum test|Median Difference (Final Values)|0.0||||0.654|TWO_SIDED|95.0|0.0|0.0|||Wilcoxon (Mann-Whitney)|||variable: easily cleaned/disinfected (at the day of discharge)||0.0|0.0|0.654
72406840|NCT02533921|144322267|SUPERIORITY||Mean Difference (Final Values)|-0.4616|STANDARD_ERROR_OF_MEAN|0.3889||0.2369|TWO_SIDED|95.0|-1.2291|0.3059|||Mixed Models Analysis||Compares the palliative care plus usual care group to the usual care group.|Comparing the mean within group change from baseline to 6 months between groups. The null hypothesis is there is no mean difference between groups.||0.3059|-1.2291|0.2369
72525814|NCT04453722|144582433|SUPERIORITY|Median difference was estimated from the Hodges-Lehmann estimator of location shift between groups and P values from Wilcoxon rank sum test|Median Difference (Final Values)|0.0||||0.929|TWO_SIDED|95.0|-1.0|1.0|||Wilcoxon (Mann-Whitney)|||variable: adequate battery life (at the day of discharge)||1.0|-1.0|0.929
72525815|NCT04453722|144582433|SUPERIORITY|Median difference was estimated from the Hodges-Lehmann estimator of location shift between groups and P values from Wilcoxon rank sum test|Median Difference (Final Values)|0.0||||0.2|TWO_SIDED|95.0|-1.0|0.0|||Wilcoxon (Mann-Whitney)|||variable: Satisfy with the electrode patch (at the day of discharge)||0.0|-1.0|0.200
72525816|NCT04453722|144582433|SUPERIORITY|Median difference was estimated from the Hodges-Lehmann estimator of location shift between groups and P values from Wilcoxon rank sum test|Median Difference (Final Values)|0.0||||0.987|TWO_SIDED|95.0|0.0|0.0|||Wilcoxon (Mann-Whitney)|||variable: Willing to use after study (at the day of discharge)||0.0|0.0|0.987
72525817|NCT04453722|144582433|SUPERIORITY|Median difference was estimated from the Hodges-Lehmann estimator of location shift between groups and P values from Wilcoxon rank sum test|Median Difference (Final Values)|0.0||||0.581|TWO_SIDED|95.0|-1.0|0.0|||Wilcoxon (Mann-Whitney)|||variable: Disturb IV line (at the day of discharge)||0.0|-1.0|0.581
72525818|NCT04453722|144582433|SUPERIORITY|Median difference was estimated from the Hodges-Lehmann estimator of location shift between groups and P values from Wilcoxon rank sum test|Median Difference (Final Values)|1.0||||0.18|TWO_SIDED|95.0|0.0|3.0|||Wilcoxon (Mann-Whitney)|||variable: Degree of disturbing daily life except sleep (after 24 hours of discharge)||3.0|0.0|0.180
72525819|NCT04453722|144582433|SUPERIORITY|Median difference was estimated from the Hodges-Lehmann estimator of location shift between groups and P values from Wilcoxon rank sum test|Median Difference (Final Values)|1.0||||0.171|TWO_SIDED|95.0|0.0|2.0|||Wilcoxon (Mann-Whitney)|||variable: degree of distributing sleep (after 24 hours of discharge)||2.0|0.0|0.171
72571252|NCT01986010|144671091|OTHER||GMT Ratio|63.0|||<|0.001|TWO_SIDED|95.0|31.9|124.6||Hypothesis is GMT Ratio \>1|Two sample t-test|||GMT Ratio: GMT V160/GMT placebo||124.6|31.9|<0.001
72571253|NCT02500641|144671106|SUPERIORITY|||||||0.5298|||||||ANCOVA|||||||0.5298
72571254|NCT00643565|144671131|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.93||||0.7189|TWO_SIDED|95.0|0.61|1.41|||Log Rank|||The HR was calculated based on a stratified Cox proportional hazards model, with stratification factors of age and histology/disease risk.||1.41|0.61|0.7189
72406841|NCT02533921|144322268|SUPERIORITY||Mean Difference (Final Values)|-0.1309||||0.7484|TWO_SIDED|95.0|-0.9349|0.673|||Mixed Models Analysis||Compares the palliative care plus usual care group to the usual care group.|||0.6730|-0.9349|0.7484
72406842|NCT02533921|144322269|SUPERIORITY||Mean Difference (Final Values)|-0.6878|STANDARD_ERROR_OF_MEAN|0.4789||0.1529|TWO_SIDED|95.0|-1.6338|0.2581|||Mixed Models Analysis||Compares the palliative care plus usual care group to the usual care group.|Comparing the mean within group change from baseline to 6 months between groups. The null hypothesis is there is no mean difference between groups.||0.2581|-1.6338|0.1529
72406843|NCT02533921|144322270|SUPERIORITY||Mean Difference (Final Values)|-0.1608|STANDARD_ERROR_OF_MEAN|0.3934||0.6834|TWO_SIDED|95.0|-0.9382|0.6167|||Mixed Models Analysis||Compares the palliative care plus usual care group to the usual care group.|Comparing the mean within group change from baseline to 6 months between groups. The null hypothesis is there is no mean difference between groups.||0.6167|-0.9382|0.6834
72406844|NCT02453113|144322283|SUPERIORITY||||||||||||||||||The statistical end point of the study will be the changes in density of CD11c+ dermal dendritic cells between two biopsies from a study subject where one sample is subjected to laser irradiation and the other is the control. For assessment of statistical significance, we will apply a paired sample t-test.|||
72406845|NCT02896400|144322296|SUPERIORITY||Odds Ratio (OR)|1.8||||0.01|TWO_SIDED|95.0|1.1|2.8|||Regression, Logistic|Adjusted for gender, age, race/ethnicity, baseline daily cigarette consumption||8 arms including BNI (BNI only, BNI+NRT, BNI+QL, BNI+Text, BNI+NRT+QL, BNI+NRT+Text, BNI+QL+Text, BNI+NRT+QL+Text) compared to the 8 arms that do not include BNI (Control, NRT only, QL only, Text only, NRT+QL, NRT+Text, QL+Text, NRT+QL+Text)||2.8|1.1|.01
72406846|NCT02896400|144322296|SUPERIORITY||Odds Ratio (OR)|2.1||||0.001|TWO_SIDED|95.0|1.3|3.2|||Regression, Logistic|adjusted for gender, age, race/ethnicity, baseline daily cigarette consumption||8 arms that include NRT (NRT only, BNI+NRT, NRT+QL, NRT+Text, BNI+NRT+QL, BNI+NRT+Text, NRT+QL+Text, BNI+NRT+QL+Text) compared to 8 arms that do not include NRT (Control, BNI only, QL only, Text only, BNI+QL, BNI+Text, QL+Text, BNI+QL+Text)||3.2|1.3|.001
72525820|NCT04453722|144582433|SUPERIORITY|Median difference was estimated from the Hodges-Lehmann estimator of location shift between groups and P values from Wilcoxon rank sum test|Median Difference (Final Values)|0.0||||0.074|TWO_SIDED|95.0|-1.0|0.0|||Wilcoxon (Mann-Whitney)|||variable: Tolerable to audible alert (after 24 hours of discharge)||0.0|-1.0|0.074
72525821|NCT04453722|144582433|SUPERIORITY|Median difference was estimated from the Hodges-Lehmann estimator of location shift between groups and P values from Wilcoxon rank sum test|Median Difference (Final Values)|0.0||||0.414|TWO_SIDED|95.0|-2.0|1.0|||Wilcoxon (Mann-Whitney)|||variable: Tolerable to tactile alert (after 24 hours of discharge)||1.0|-2.0|0.414
72525822|NCT04453722|144582433|SUPERIORITY|Median difference was estimated from the Hodges-Lehmann estimator of location shift between groups and P values from Wilcoxon rank sum test|Median Difference (Final Values)|0.0||||0.506|TWO_SIDED|95.0|0.0|0.0|||Wilcoxon (Mann-Whitney)|||variable: Easily cleaned/disinfected (after 24 hours of discharge)||0.0|0.0|0.506
72406847|NCT02896400|144322296|SUPERIORITY||Odds Ratio (OR)|1.4||||0.14|TWO_SIDED|95.0|0.9|2.2|||Regression, Logistic|adjusted for gender, age, race/ethnicity, baseline daily cigarette consumption||8 arms including QL intervention (QL only, BNI+QL, NRT+QL, QL+Text, BNI+NRT+QL, BNI+QL+Text, NRT+QL+Text, BNI+NRT+QL+Text) compared to all 8 arms that did not include QL (Control, BNI only, NRT only, Text only, BNI+NRT, BNI+Text, NRT+Text, BNI+NRT+Text)||2.2|0.9|0.14
72406848|NCT02896400|144322296|SUPERIORITY||Odds Ratio (OR)|1.1||||0.64|TWO_SIDED|95.0|0.7|1.7|||Regression, Logistic|adjusted for gender, age, race/ethnicity, baseline daily cigarette consumption||8 arms including Text (Text only, BNI+Text, NRT+Text, QL+Text, BNI+NRT+Text, BNI+QL+Text, NRT+QL+Text, BNI+NRT+QL+Text) compared to 8 arms that do not include Text (Control, BNI only, NRT only, QL only, BNI+NRT, BNI+QL, NRT+QL, BNI+NRT+QL)||1.7|0.7|0.64
72406849|NCT00326612|144322306|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.8||||||95.0||||||||||||
72406850|NCT00326612|144322307|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.8||||||95.0|0.2|3.9||||||||3.9|0.2|
72406851|NCT00326612|144322308|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.1||||||95.0|0.4|2.7||||||||2.7|0.4|
72406852|NCT00326612|144322309|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.1||||||95.0|0.2|8.2||||||||8.2|0.2|
72525823|NCT04453722|144582433|SUPERIORITY|Median difference was estimated from the Hodges-Lehmann estimator of location shift between groups and P values from Wilcoxon rank sum test|Median Difference (Final Values)|0.0||||0.747|TWO_SIDED|95.0|-1.0|0.0|||Wilcoxon (Mann-Whitney)|||variable: Adequate battery life (after 24 hours of discharge)||0.0|-1.0|0.747
72525824|NCT04453722|144582433|SUPERIORITY|Median difference was estimated from the Hodges-Lehmann estimator of location shift between groups and P values from Wilcoxon rank sum test|Median Difference (Final Values)|-1.0||||0.023|TWO_SIDED|95.0|-2.0|0.0|||Wilcoxon (Mann-Whitney)|||variable: satisfy with the electrode patch (after 24 hours of discharge)||0.0|-2.0|0.023
72406853|NCT00326612|144322310|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.8||||||95.0|0.0|67.3||||||||67.3|0.0|
72406854|NCT00326612|144322311|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.6||||||95.0|0.2|140.7||||||||140.7|0.2|
72406855|NCT00548808|144322314|NON_INFERIORITY_OR_EQUIVALENCE|A noninferiority margin of 0.4% for HbA1c was used.|Least Squares Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.11||0.716|TWO_SIDED|95.0|-0.25|0.17|||ANCOVA|ANCOVA Model: Change in HbA1c = Treatment + Baseline + Country + Sulfonylurea use (Type III sums of squares).|Least Squares Mean Difference = Insulin Lispro LM minus Insulin Glargine.|||0.17|-0.25|0.716
72406856|NCT00548808|144322315|SUPERIORITY_OR_OTHER|||||||0.279||95.0||||P-value for 16 Week Change from Baseline.|Mixed Models Analysis|Mixed Model Analysis: Change in HbA1c = Treatment + Baseline + Country + Sulfonylurea use + Visit + Treatment\*Visit (Type 3 sums of squares).||||||0.279
72406857|NCT00548808|144322315|SUPERIORITY_OR_OTHER|||||||0.846||95.0||||P-value for 32 Week Change from Baseline.|Mixed Models Analysis|Mixed Model Analysis: Change in HbA1c = Treatment + Baseline + Country + Sulfonylurea use + Visit + Treatment\*Visit (Type 3 sums of squares).||||||0.846
72525825|NCT04453722|144582433|SUPERIORITY|Median difference was estimated from the Hodges-Lehmann estimator of location shift between groups and P values from Wilcoxon rank sum test|Median Difference (Final Values)|0.0||||0.023|TWO_SIDED|95.0|-1.0|0.0|||Wilcoxon (Mann-Whitney)|||variable: Willing to use after study (after 24 hours of discharge)||0.0|-1.0|0.023
72571255|NCT00643565|144671132|SUPERIORITY||Hazard Ratio (HR)|0.8||||0.3211|TWO_SIDED|95.0|0.51|1.25|||Log Rank|||The HR was calculated based on a stratified Cox proportional hazards model, with stratification factors of age and histology/disease risk.||1.25|0.51|0.3211
72406858|NCT00548808|144322315|SUPERIORITY_OR_OTHER|||||||0.741||95.0||||P-value for 48 Week Change from Baseline.|Mixed Models Analysis|Mixed Model Analysis: Change in HbA1c = Treatment + Baseline + Country + Sulfonylurea use + Visit + Treatment\*Visit (Type 3 sums of squares).||||||0.741
72525826|NCT04453722|144582434|SUPERIORITY|Median difference was estimated from the Hodges-Lehmann estimator of location shift between groups and P values from Wilcoxon rank sum test.|Median Difference (Final Values)|0.0||||0.73|TWO_SIDED|95.0|-1.0|0.0|||Wilcoxon (Mann-Whitney)|||Degree of disturbing routine work||0.0|-1.0|0.73
72525827|NCT04453722|144582434|SUPERIORITY|Median difference was estimated from the Hodges-Lehmann estimator of location shift between groups and P values from Wilcoxon rank sum test.|Median Difference (Final Values)|0.0||||0.097|TWO_SIDED|95.0|0.0|1.0|||Wilcoxon (Mann-Whitney)|||Easily cleaned/disinfected||1.0|0.0|0.097
72525828|NCT04453722|144582434|SUPERIORITY|Median difference was estimated from the Hodges-Lehmann estimator of location shift between groups and P values from Wilcoxon rank sum test.|Median Difference (Final Values)|1.0||||0.02|TWO_SIDED|95.0|0.0|1.0|||Wilcoxon (Mann-Whitney)|||variable: Adequate battery life||1.0|0.0|0.02
72525829|NCT04453722|144582434|SUPERIORITY|Median difference was estimated from the Hodges-Lehmann estimator of location shift between groups and P values from Wilcoxon rank sum test.|Median Difference (Final Values)|0.0||||0.037|TWO_SIDED|95.0|0.0|1.0|||Wilcoxon (Mann-Whitney)|||variable: Satisfy with the electrode patch||1.0|0.0|0.037
72525830|NCT04453722|144582434|SUPERIORITY|Median difference was estimated from the Hodges-Lehmann estimator of location shift between groups and P values from Wilcoxon rank sum test.|Median Difference (Final Values)|0.0||||0.482|TWO_SIDED|95.0|-2.0|1.0|||Wilcoxon (Mann-Whitney)|||variable: Tolerable to audible alert||1.0|-2.0|0.482
72525831|NCT04453722|144582434|SUPERIORITY|Median difference was estimated from the Hodges-Lehmann estimator of location shift between groups and P values from Wilcoxon rank sum test.|Median Difference (Final Values)|0.0||||0.031|TWO_SIDED|95.0|0.0|1.0|||Wilcoxon (Mann-Whitney)|||variable: Willing to use after study||1.0|0.0|0.031
72525832|NCT04453722|144582434|SUPERIORITY|Median difference was estimated from the Hodges-Lehmann estimator of location shift between groups and P values from Wilcoxon rank sum test.|Median Difference (Final Values)|0.0||||0.947|TWO_SIDED|95.0|0.0|1.0||variable: Patients' complaint about the device|Wilcoxon (Mann-Whitney)|||variable: Patients' complaint about the device||1.0|0.0|0.947
72525833|NCT04453722|144582434|SUPERIORITY|Median difference was estimated from the Hodges-Lehmann estimator of location shift between groups and P values from Wilcoxon rank sum test.|Median Difference (Final Values)|0.0||||0.324|TWO_SIDED|95.0|0.0|0.0|||Wilcoxon (Mann-Whitney)|||variable: Disturb IV line||0.0|0.0|0.324
72525834|NCT01263470|144582435|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.57|||||TWO_SIDED|95.0|-0.755|-0.386||||||||-0.386|-0.755|
72525835|NCT01263470|144582435|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.762|||||TWO_SIDED|95.0|-0.925|-0.598||||||||-0.598|-0.925|
72525836|NCT01263470|144582435|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.826|||||TWO_SIDED|95.0|-0.987|-0.665||||||||-0.665|-0.987|
72406859|NCT00548808|144322316|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.79||||0.465|TWO_SIDED|95.0|0.41|1.5||P-value for patients achieving HbA1c \<6.5% at 16 weeks.|Regression, Logistic|Generalized Estimating Equation model with fixed effects for treatment, country, sulfonylurea use, baseline HbA1c, visit, and visit\*treatment.||||1.50|0.41|0.465
72525837|NCT01263470|144582435|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.887|||||TWO_SIDED|95.0|-1.035|-0.739||||||||-0.739|-1.035|
72525838|NCT01263470|144582435|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.351|||||TWO_SIDED|95.0|-0.57|-0.132||||||||-0.132|-0.570|
72525839|NCT01263470|144582435|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.542|||||TWO_SIDED|95.0|-0.743|-0.342||||||||-0.342|-0.743|
72525840|NCT01263470|144582435|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.607|||||TWO_SIDED|95.0|-0.808|-0.406||||||||-0.406|-0.808|
72525841|NCT01263470|144582435|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.667|||||TWO_SIDED|95.0|-0.859|-0.475||||||||-0.475|-0.859|
72525842|NCT01263470|144582436|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.158|||||TWO_SIDED|95.0|-0.213|-0.104||||||||-0.104|-0.213|
72525843|NCT01263470|144582436|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.174|||||TWO_SIDED|95.0|-0.234|-0.114||||||||-0.114|-0.234|
72525844|NCT01263470|144582436|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.16|||||TWO_SIDED|95.0|-0.219|-0.1||||||||-0.100|-0.219|
72525845|NCT01263470|144582436|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.153|||||TWO_SIDED|95.0|-0.212|-0.095||||||||-0.095|-0.212|
72525846|NCT01263470|144582436|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.059|||||TWO_SIDED|95.0|-0.116|-0.003||||||||-0.003|-0.116|
72525847|NCT01263470|144582436|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.075|||||TWO_SIDED|95.0|-0.136|-0.014||||||||-0.014|-0.136|
72525848|NCT01263470|144582436|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.061|||||TWO_SIDED|95.0|-0.121|0.0||||||||0.000|-0.121|
72525849|NCT01263470|144582436|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.054|||||TWO_SIDED|95.0|-0.114|0.006||||||||0.006|-0.114|
72525850|NCT01263470|144582437|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.326|||||TWO_SIDED|95.0|-0.419|-0.233||||||||-0.233|-0.419|
72576760|NCT00261443|144680647|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.01||||0.911|TWO_SIDED|95.0|-0.16|0.15||ANOVA model, controlling for treatment, mood stabilizer, and index mood episode used for baseline. ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, and baseline value used for mean change from baseline.|ANOVA/ANCOVA|Means, difference in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Baseline Comparison||0.15|-0.16|0.911
72406860|NCT00548808|144322316|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.81||||0.365|TWO_SIDED|95.0|0.51|1.28||P-value for Patients Achieving HbA1c \<7% at 16 Weeks.|Regression, Logistic|Generalized Estimating Equation model with fixed effects for treatment, country, sulfonylurea use, baseline HbA1c, visit, and visit\*treatment.||||1.28|0.51|0.365
72525851|NCT01263470|144582437|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.369|||||TWO_SIDED|95.0|-0.47|-0.268||||||||-0.268|-0.470|
72525852|NCT01263470|144582437|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.34|||||TWO_SIDED|95.0|-0.438|-0.241||||||||-0.241|-0.438|
72525853|NCT01263470|144582437|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.387|||||TWO_SIDED|95.0|-0.485|-0.288||||||||-0.288|-0.485|
72525854|NCT01263470|144582437|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.178|||||TWO_SIDED|95.0|-0.28|-0.076||||||||-0.076|-0.280|
72525855|NCT01263470|144582437|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.221|||||TWO_SIDED|95.0|-0.329|-0.112||||||||-0.112|-0.329|
72525856|NCT01263470|144582437|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.192|||||TWO_SIDED|95.0|-0.299|-0.085||||||||-0.085|-0.299|
72525857|NCT01263470|144582437|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.239|||||TWO_SIDED|95.0|-0.346|-0.131||||||||-0.131|-0.346|
72525858|NCT01263470|144582438|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5|||||TWO_SIDED|95.0|-0.644|-0.356||||||||-0.356|-0.644|
72406861|NCT00548808|144322316|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.12||||0.683|TWO_SIDED|95.0|0.65|1.95||P-value for patients achieving HbA1c \<6.5% at 32 weeks.|Regression, Logistic|Generalized Estimating Equation model with fixed effects for treatment, country, sulfonylurea use, baseline HbA1c, visit, and visit\*treatment.||||1.95|0.65|0.683
72525859|NCT01263470|144582438|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.614|||||TWO_SIDED|95.0|-0.763|-0.464||||||||-0.464|-0.763|
72525860|NCT01263470|144582438|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.66|||||TWO_SIDED|95.0|-0.804|-0.516||||||||-0.516|-0.804|
72525861|NCT01263470|144582438|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.695|||||TWO_SIDED|95.0|-0.832|-0.559||||||||-0.559|-0.832|
72525862|NCT01263470|144582438|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.325|||||TWO_SIDED|95.0|-0.494|-0.156||||||||-0.156|-0.494|
72525863|NCT01263470|144582438|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.438|||||TWO_SIDED|95.0|-0.61|-0.267||||||||-0.267|-0.610|
72525864|NCT01263470|144582438|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.485|||||TWO_SIDED|95.0|-0.654|-0.315||||||||-0.315|-0.654|
72525865|NCT01263470|144582438|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.52|||||TWO_SIDED|95.0|-0.683|-0.357||||||||-0.357|-0.683|
72525866|NCT01263470|144582439|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.6|||||TWO_SIDED|95.0|-23.27|-7.93||||||||-7.93|-23.27|
72525867|NCT01263470|144582439|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.69|||||TWO_SIDED|95.0|-25.34|-10.05||||||||-10.05|-25.34|
72525868|NCT01263470|144582439|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.08|||||TWO_SIDED|95.0|-24.14|-8.02||||||||-8.02|-24.14|
72525869|NCT01263470|144582439|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-23.47|||||TWO_SIDED|95.0|-32.06|-14.89||||||||-14.89|-32.06|
72525870|NCT01263470|144582439|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.82|||||TWO_SIDED|95.0|-12.66|1.02||||||||1.02|-12.66|
72525871|NCT01263470|144582439|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.92|||||TWO_SIDED|95.0|-14.76|-1.08||||||||-1.08|-14.76|
72525872|NCT01263470|144582439|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.3|||||TWO_SIDED|95.0|-13.53|0.93||||||||0.93|-13.53|
72525873|NCT01263470|144582439|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.69|||||TWO_SIDED|95.0|-21.45|-5.94||||||||-5.94|-21.45|
72525874|NCT01263470|144582440|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.6|||||TWO_SIDED|95.0|-23.27|-7.93||||||||-7.93|-23.27|
72525875|NCT01263470|144582440|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.69|||||TWO_SIDED|95.0|-25.34|-10.05||||||||-10.05|-25.34|
72525876|NCT01263470|144582440|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.08|||||TWO_SIDED|95.0|-24.14|-8.02||||||||-8.02|-24.14|
72525877|NCT01263470|144582440|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-23.47|||||TWO_SIDED|95.0|-32.06|-14.89||||||||-14.89|-32.06|
72525878|NCT01263470|144582440|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.82|||||TWO_SIDED|95.0|-12.66|1.02||||||||1.02|-12.66|
72525879|NCT01263470|144582440|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.92|||||TWO_SIDED|95.0|-14.76|-1.08||||||||-1.08|-14.76|
72525880|NCT01263470|144582440|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.3|||||TWO_SIDED|95.0|-13.53|0.93||||||||0.93|-13.53|
72525881|NCT01263470|144582440|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.69|||||TWO_SIDED|95.0|-21.45|-5.94||||||||-5.94|-21.45|
72525882|NCT01263470|144582441|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.73|||||TWO_SIDED|95.0|-26.52|-8.94||||||||-8.94|-26.52|
72525883|NCT01263470|144582441|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-24.22|||||TWO_SIDED|95.0|-32.07|-16.37||||||||-16.37|-32.07|
72525884|NCT01263470|144582441|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-24.34|||||TWO_SIDED|95.0|-32.03|-16.65||||||||-16.65|-32.03|
72525885|NCT01263470|144582441|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-28.28|||||TWO_SIDED|95.0|-37.04|-19.52||||||||-19.52|-37.04|
72525886|NCT01263470|144582441|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.55|||||TWO_SIDED|95.0|-17.28|0.18||||||||0.18|-17.28|
72525887|NCT01263470|144582441|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.04|||||TWO_SIDED|95.0|-22.9|-7.18||||||||-7.18|-22.90|
72525888|NCT01263470|144582441|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.16|||||TWO_SIDED|95.0|-22.9|-7.42||||||||-7.42|-22.90|
72525889|NCT01263470|144582441|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.1|||||TWO_SIDED|95.0|-27.8|-10.4||||||||-10.40|-27.80|
72525890|NCT01263470|144582442|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.92|||||TWO_SIDED|95.0|-24.19|-5.64||||||||-5.64|-24.19|
72525891|NCT01263470|144582442|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-20.17|||||TWO_SIDED|95.0|-27.86|-12.48||||||||-12.48|-27.86|
72525892|NCT01263470|144582442|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-23.07|||||TWO_SIDED|95.0|-30.41|-15.73||||||||-15.73|-30.41|
72525893|NCT01263470|144582442|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-28.17|||||TWO_SIDED|95.0|-36.05|-20.29||||||||-20.29|-36.05|
72525894|NCT01263470|144582442|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.27|||||TWO_SIDED|95.0|-15.6|3.06||||||||3.06|-15.60|
72525895|NCT01263470|144582442|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.52|||||TWO_SIDED|95.0|-19.41|-3.64||||||||-3.64|-19.41|
72525896|NCT01263470|144582442|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.42|||||TWO_SIDED|95.0|-22.04|-6.8||||||||-6.80|-22.04|
72525897|NCT01263470|144582442|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.52|||||TWO_SIDED|95.0|-27.61|-11.43||||||||-11.43|-27.61|
72525898|NCT01263470|144582443|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.145|||||TWO_SIDED|95.0|-0.384|0.094||||||||0.094|-0.384|
72525899|NCT01263470|144582443|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.134|||||TWO_SIDED|95.0|-0.106|0.374||||||||0.374|-0.106|
72525900|NCT01263470|144582443|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.144|||||TWO_SIDED|95.0|-0.103|0.39||||||||0.390|-0.103|
72525901|NCT01263470|144582443|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.004|||||TWO_SIDED|95.0|-0.218|0.227||||||||0.227|-0.218|
72525902|NCT01263470|144582443|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.002|||||TWO_SIDED|95.0|-0.241|0.245||||||||0.245|-0.241|
72525903|NCT01263470|144582443|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.281|||||TWO_SIDED|95.0|0.038|0.524||||||||0.524|0.038|
72525904|NCT01263470|144582443|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.291|||||TWO_SIDED|95.0|0.041|0.54||||||||0.540|0.041|
72525905|NCT01263470|144582443|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.151|||||TWO_SIDED|95.0|-0.077|0.38||||||||0.380|-0.077|
72525906|NCT01263470|144582444|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.045|||||TWO_SIDED|95.0|-0.245|0.156||||||||0.156|-0.245|
72525907|NCT01263470|144582444|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.012|||||TWO_SIDED|95.0|-0.185|0.21||||||||0.210|-0.185|
72525908|NCT01263470|144582444|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.158|||||TWO_SIDED|95.0|-0.053|0.369||||||||0.369|-0.053|
72525909|NCT01263470|144582444|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.048|||||TWO_SIDED|95.0|-0.14|0.235||||||||0.235|-0.140|
72525910|NCT01263470|144582444|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.122|||||TWO_SIDED|95.0|-0.097|0.341||||||||0.341|-0.097|
72525911|NCT01263470|144582444|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.179|||||TWO_SIDED|95.0|-0.036|0.395||||||||0.395|-0.036|
72525912|NCT01263470|144582444|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.325|||||TWO_SIDED|95.0|0.097|0.553||||||||0.553|0.097|
72625291|NCT01098747|144780085|SUPERIORITY_OR_OTHER||Difference in proportion|72.61|||<|0.001|TWO_SIDED|95.0|61.05|84.17||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||2 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||84.17|61.05|<0.001
72525913|NCT01263470|144582444|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.215|||||TWO_SIDED|95.0|0.006|0.423||||||||0.423|0.006|
72525914|NCT01263470|144582445|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.117|||||TWO_SIDED|95.0|-0.444|0.209||||||||0.209|-0.444|
72525915|NCT01263470|144582445|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|||||TWO_SIDED|95.0|-0.362|0.162||||||||0.162|-0.362|
72525916|NCT01263470|144582445|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.079|||||TWO_SIDED|95.0|-0.166|0.324||||||||0.324|-0.166|
72525917|NCT01263470|144582445|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.117|||||TWO_SIDED|95.0|-0.355|0.121||||||||0.121|-0.355|
72525918|NCT01263470|144582445|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.102|||||TWO_SIDED|95.0|-0.203|0.408||||||||0.408|-0.203|
72525919|NCT01263470|144582445|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.12|||||TWO_SIDED|95.0|-0.124|0.364||||||||0.364|-0.124|
72525920|NCT01263470|144582445|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.299|||||TWO_SIDED|95.0|0.071|0.526||||||||0.526|0.071|
72525921|NCT01263470|144582445|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.102|||||TWO_SIDED|95.0|-0.118|0.322||||||||0.322|-0.118|
72525922|NCT01263470|144582446|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.039|||||TWO_SIDED|95.0|-0.23|0.308||||||||0.308|-0.230|
72525923|NCT01263470|144582446|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.175|||||TWO_SIDED|95.0|-0.029|0.379||||||||0.379|-0.029|
72525924|NCT01263470|144582446|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.248|||||TWO_SIDED|95.0|0.044|0.453||||||||0.453|0.044|
72525925|NCT01263470|144582446|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.186|||||TWO_SIDED|95.0|-0.035|0.407||||||||0.407|-0.035|
72525926|NCT01263470|144582446|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.052|||||TWO_SIDED|95.0|-0.236|0.34||||||||0.340|-0.236|
72525927|NCT01263470|144582446|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.188|||||TWO_SIDED|95.0|-0.044|0.421||||||||0.421|-0.044|
72525928|NCT01263470|144582446|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.261|||||TWO_SIDED|95.0|0.026|0.496||||||||0.496|0.026|
72525929|NCT01263470|144582446|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.199|||||TWO_SIDED|95.0|-0.049|0.448||||||||0.448|-0.049|
72525930|NCT01263470|144582447|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-23.85|||||TWO_SIDED|95.0|-38.75|-8.94||||||||-8.94|-38.75|
72525931|NCT01263470|144582447|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-23.38|||||TWO_SIDED|95.0|-37.14|-9.61||||||||-9.61|-37.14|
72525932|NCT01263470|144582447|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-40.6|||||TWO_SIDED|95.0|-53.18|-28.02||||||||-28.02|-53.18|
72525933|NCT01263470|144582447|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-42.75|||||TWO_SIDED|95.0|-54.93|-30.58||||||||-30.58|-54.93|
72525934|NCT01263470|144582447|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.36|||||TWO_SIDED|95.0|-19.7|8.98||||||||8.98|-19.70|
72525935|NCT01263470|144582447|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.89|||||TWO_SIDED|95.0|-18.13|8.35||||||||8.35|-18.13|
72525936|NCT01263470|144582447|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-22.11|||||TWO_SIDED|95.0|-34.22|-10.01||||||||-10.01|-34.22|
72525937|NCT01263470|144582447|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-24.27|||||TWO_SIDED|95.0|-35.98|-12.55||||||||-12.55|-35.98|
72525938|NCT01263470|144582448|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-58.31|||||TWO_SIDED|95.0|-80.79|-35.83||||||||-35.83|-80.79|
72525939|NCT01263470|144582448|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-60.66|||||TWO_SIDED|95.0|-80.84|-40.47||||||||-40.47|-80.84|
72525940|NCT01263470|144582448|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-78.72|||||TWO_SIDED|95.0|-97.03|-60.4||||||||-60.40|-97.03|
72525941|NCT01263470|144582448|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-87.43|||||TWO_SIDED|95.0|-106.26|-68.6||||||||-68.60|-106.26|
72406862|NCT00548808|144322316|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.06||||0.81|TWO_SIDED|95.0|0.68|1.64||P-value for patients achieving HbA1c \<7% at 32 weeks.|Regression, Logistic|Generalized Estimating Equation model with fixed effects for treatment, country, sulfonylurea use, baseline HbA1c, visit, and visit\*treatment.||||1.64|0.68|0.810
72406863|NCT00548808|144322316|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.17||||0.555|TWO_SIDED|95.0|0.69|2.01||P-value for patients achieving HbA1c \<6.5% at 48 weeks.|Regression, Logistic|Generalized Estimating Equation model with fixed effects for treatment, country, sulfonylurea use, baseline HbA1c, visit, and visit\*treatment.||||2.01|0.69|0.555
72406864|NCT00548808|144322316|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.05||||0.829|TWO_SIDED|95.0|0.67|1.64||P-value for patients achieving HbA1c \<7% at 48 weeks.|Regression, Logistic|Generalized Estimating Equation model with fixed effects for treatment, country, sulfonylurea use, baseline HbA1c, visit, and visit\*treatment.||||1.64|0.67|0.829
72525942|NCT01263470|144582448|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.73|||||TWO_SIDED|95.0|-24.69|19.23||||||||19.23|-24.69|
72525943|NCT01263470|144582448|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.07|||||TWO_SIDED|95.0|-24.85|14.7||||||||14.70|-24.85|
72525944|NCT01263470|144582448|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-23.13|||||TWO_SIDED|95.0|-41.16|-5.11||||||||-5.11|-41.16|
72525945|NCT01263470|144582448|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-31.84|||||TWO_SIDED|95.0|-50.36|-13.33||||||||-13.33|-50.36|
72525946|NCT01263470|144582449|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.859|||||TWO_SIDED|95.0|-2.736|8.455||||||||8.455|-2.736|
72525947|NCT01263470|144582449|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.456|||||TWO_SIDED|95.0|0.748|10.165||||||||10.165|0.748|
72525948|NCT01263470|144582449|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.715|||||TWO_SIDED|95.0|3.181|12.248||||||||12.248|3.181|
72525949|NCT01263470|144582449|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.557|||||TWO_SIDED|95.0|-3.763|8.877||||||||8.877|-3.763|
72525950|NCT01263470|144582449|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.66|||||TWO_SIDED|95.0|7.924|21.396||||||||21.396|7.924|
72525951|NCT01263470|144582449|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|17.257|||||TWO_SIDED|95.0|11.353|23.16||||||||23.160|11.353|
72525952|NCT01263470|144582449|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|19.515|||||TWO_SIDED|95.0|13.629|25.401||||||||25.401|13.629|
72525953|NCT01263470|144582449|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.357|||||TWO_SIDED|95.0|7.013|21.701||||||||21.701|7.013|
72525954|NCT01263470|144582450|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.535|||||TWO_SIDED|95.0|-0.019|1.089||||||||1.089|-0.019|
72406865|NCT00548808|144322318|SUPERIORITY_OR_OTHER|||||||0.604||95.0||||P-value for Week 16 Change from Baseline|Mixed Models Analysis|Mixed Model Analysis: Change in Blood Glucose = Treatment + Baseline + Country + HbA1c stratum + Sulfonylurea use + Visit + Treatment\*Visit||||||0.604
72525955|NCT01263470|144582450|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.764|||||TWO_SIDED|95.0|0.214|1.315||||||||1.315|0.214|
72525956|NCT01263470|144582450|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.999|||||TWO_SIDED|95.0|0.418|1.58||||||||1.580|0.418|
72525957|NCT01263470|144582450|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.959|||||TWO_SIDED|95.0|0.43|1.489||||||||1.489|0.430|
72525958|NCT01263470|144582450|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.934|||||TWO_SIDED|95.0|0.315|1.552||||||||1.552|0.315|
72525959|NCT01263470|144582450|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.163|||||TWO_SIDED|95.0|0.551|1.774||||||||1.774|0.551|
72525960|NCT01263470|144582450|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.398|||||TWO_SIDED|95.0|0.759|2.036||||||||2.036|0.759|
72525961|NCT01263470|144582450|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.358|||||TWO_SIDED|95.0|0.76|1.956||||||||1.956|0.760|
72525962|NCT01263470|144582451|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.25|||||TWO_SIDED|95.0|-7.87|16.38||||||||16.38|-7.87|
72525963|NCT01263470|144582451|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.26|||||TWO_SIDED|95.0|-0.9|23.42||||||||23.42|-0.90|
72525964|NCT01263470|144582451|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.19|||||TWO_SIDED|95.0|-10.56|16.95||||||||16.95|-10.56|
72525965|NCT01263470|144582451|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.66|||||TWO_SIDED|95.0|-16.27|8.94||||||||8.94|-16.27|
72525966|NCT01263470|144582451|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.75|||||TWO_SIDED|95.0|-9.79|19.29||||||||19.29|-9.79|
72525967|NCT01263470|144582451|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.76|||||TWO_SIDED|95.0|-2.67|26.19||||||||26.19|-2.67|
72525968|NCT01263470|144582451|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.69|||||TWO_SIDED|95.0|-12.02|19.4||||||||19.40|-12.02|
72525969|NCT01263470|144582451|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.17|||||TWO_SIDED|95.0|-18.04|11.71||||||||11.71|-18.04|
72525970|NCT02723019|144582529|SUPERIORITY|||||||0.01|||||||Regression, Logistic|||Analyzed using logistic regression analysis||||0.01
72525971|NCT02723019|144582530|SUPERIORITY|||||||0.19|||||||Regression, Logistic|||||||0.19
72525972|NCT02723019|144582531|SUPERIORITY|||||||0.73||||||P-value is for the time by group interaction effect, testing the difference in rate of change between the Intervention and Control groups from baseline to 6 months post baseline|multilevel model analysis, random interc|||multilevel model analysis, random intercepts and slopes, appropriate link function for outcome, full maximum likelihood estimation||||0.73
72525973|NCT02723019|144582532|SUPERIORITY|||||||0.28||||||P-value is for the time by group interaction effect, testing the difference in rate of change between the Intervention and Control groups from baseline to 6 months post baseline|multilevel model analysis, random interc|||multilevel model analysis, random intercepts and slopes, appropriate link function for outcome, full maximum likelihood estimation||||0.28
72525974|NCT02723019|144582533|SUPERIORITY|||||||0.71||||||P-value is for the time by group interaction effect, testing the difference in rate of change between the Intervention and Control groups from baseline to 6 months post baseline|multilevel model analysis, random interc|||multilevel model analysis, random intercepts and slopes, appropriate link function for outcome, full maximum likelihood estimation||||0.71
72525975|NCT02723019|144582534|SUPERIORITY|||||||0.42|||||||negative binomial regression model analy|||negative binomial regression model analysis||||0.42
72571256|NCT02980874|144671158|SUPERIORITY||Difference in percentages|-6.1||||0.187|TWO_SIDED|95.0|-15.2|3.0||The a priori threshold for statistical significance was 0.050. Prior to evaluating the results of the CMH test, a Breslow-Day test with Tarone's adjustment was conducted to confirm the homogeneity of the odds ratios between RVO strata.|Cochran-Mantel-Haenszel|The CMH test was stratified by the type of retinal vein occlusion, i.e., branch vs. central.|Estimated value was calculated as the percentage of subjects in the Active arm meeting the primary endpoint minus the percentage of subjects in the Control arm meeting the primary endpoint.|Based on a Pearson chi-square test, a total sample size of approximately 460 subjects provided 90% power to detect a difference of 15% between the Active and Control arms assuming the Control arm showed a proportion of 0.50 at 8 weeks. The primary analysis was a test of superiority of the Active arm over the Control arm, and was based on a Cochran-Mantel-Haenszel chi-square test stratified by type of retinal vein occlusion.||3.0|-15.2|0.187
72571257|NCT01150890|144671189|SUPERIORITY|||||||0.1941|||||||Overall Trend test|||The primary null hypothesis was tested sequentially using a linear trend test at the significance level of 0.05 (two-sided) using logistic regression modeling.||||0.1941
72571258|NCT01150890|144671189|SUPERIORITY||Difference in Response Rate|0.0||||1|TWO_SIDED|95.0|-0.09|0.09|||Chi-squared|||||0.09|-0.09|1.0000
72571259|NCT01150890|144671189|SUPERIORITY||Difference in Response Rate|0.1203||||0.0966|TWO_SIDED|95.0|-0.02|0.26|||Chi-squared|||||0.26|-0.02|0.0966
72625292|NCT01098747|144780085|SUPERIORITY_OR_OTHER||Difference in proportion|7.81||||0.036|TWO_SIDED|95.0|1.54|14.08||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||2 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||14.08|1.54|0.036
72525976|NCT00515099|144582535|SUPERIORITY_OR_OTHER|||||||0.6|TWO_SIDED|||||P-value is for testing treatment effect using an analysis of covariance with baseline ln(AUC+1) as a covariate and change in ln(AUC+1) from baseline as the outcome variable.|ANCOVA|||Primary imputation method used for missing Month 12 AUC. Measuring range for C-peptide is 0.05-30 ng/mL||||0.60
72525977|NCT00515099|144582536|SUPERIORITY_OR_OTHER|||||||0.4|TWO_SIDED|||||P-value is for testing treatment effect using an analysis of covariance with baseline In(AUC+1) as a covariate and change in In(AUC+1) from baseline as the outcome variable|ANCOVA|||Missing Month 12 AUC values were not imputed. Measuring range for C-peptide is 0.05-30 ng/mL||||0.40
72525978|NCT00515099|144582537|SUPERIORITY_OR_OTHER|||||||0.59|TWO_SIDED|||||P-value is for testing treatment effect using an analysis of covariance with baseline level as a covariate and change in insulin use from baseline as the outcome variable|ANCOVA|||Comparison of groups for change from baseline (pre-treatment initiation) to Month 12||||0.59
72525979|NCT00515099|144582537|SUPERIORITY_OR_OTHER|||||||0.14|TWO_SIDED|||||P-value is for testing treatment effect using an analysis of covariance with baseline level as a covariate and change in insulin use from baseline as the outcome variable|ANCOVA|||Comparison of groups for change from baseline (pre-treatment initiation) to Month 24||||0.14
72525980|NCT00515099|144582539|SUPERIORITY_OR_OTHER||||||>|0.099|TWO_SIDED|||||P-value is for testing treatment effect using an analysis of covariance with baseline level as a covariate and change in insulin use from baseline as the outcome variable|Fisher Exact|||Comparison of groups up to Month 12||||>0.099
72525981|NCT00515099|144582539|SUPERIORITY_OR_OTHER|||||||0.75|TWO_SIDED|||||P-value is for testing treatment effect using an analysis of covariance with baseline level as a covariate and change in insulin use from baseline as the outcome variable|Fisher Exact|||Comparison of groups up to Month 24||||0.75
72571260|NCT01150890|144671189|SUPERIORITY||Difference in Response Rate|0.0597||||0.3208|TWO_SIDED|95.0|-0.06|0.17|||Chi-squared|||||0.17|-0.06|0.3208
72571261|NCT01150890|144671190|SUPERIORITY||Difference in Response Rate|0.0363||||0.6831|TWO_SIDED|95.0|-0.14|0.21|||Chi-squared|||||0.21|-0.14|0.6831
72571262|NCT01150890|144671190|SUPERIORITY||Difference in Response Rate|0.1477||||0.1396|TWO_SIDED|95.0|-0.04|0.34|||Chi-squared|||||0.34|-0.04|0.1396
72571263|NCT01150890|144671190|SUPERIORITY||Difference in Response Rate|0.0265||||0.7588|TWO_SIDED|95.0|-0.14|0.19|||Chi-squared|||||0.19|-0.14|0.7588
72625293|NCT01098747|144780085|SUPERIORITY_OR_OTHER||Difference in proportion|72.61|||<|0.001|TWO_SIDED|95.0|61.05|84.17||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||3 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||84.17|61.05|<0.001
72625294|NCT01098747|144780085|SUPERIORITY_OR_OTHER||Difference in proportion|7.28||||0.047|TWO_SIDED|95.0|1.07|13.48||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||3 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||13.48|1.07|0.047
72625295|NCT01098747|144780085|SUPERIORITY_OR_OTHER||Difference in proportion|72.61|||<|0.001|TWO_SIDED|95.0|61.05|84.17||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||4 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||84.17|61.05|<0.001
72571264|NCT01150890|144671191|SUPERIORITY|||||||0.4161|||||||ANCOVA|Analysis of covariance (ANCOVA) model adjusted for baseline CDAI score.||||||0.4161
72571265|NCT01150890|144671191|SUPERIORITY|||||||0.8094|||||||ANCOVA|ANCOVA model adjusted for baseline CDAI score.||||||0.8094
72571266|NCT01150890|144671191|SUPERIORITY|||||||0.304|||||||ANCOVA|ANCOVA model adjusted for baseline CDAI score.||||||0.3040
72571267|NCT00922987|144671198|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||Signed Rank Test|||||||<0.0001
72571268|NCT00446199|144671206|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||significance level of 1.7% is used to adjust (Bonferroni) for the comparison of three active arms with Placebo.|Wilcoxon/van Elteren|stratification by center||Comparison between DRSP/E2 (0.5mg/0.5mg) and Placebo with respect to a shift in the distribution of the end point. Null hypothesis: The distribution of the change from baseline to week 12 in the number of hot flushes is identical in both arms, alternative: there is a shift in the distribution.||||<0.0001
72406866|NCT00548808|144322318|SUPERIORITY_OR_OTHER|||||||0.814||95.0||||P-value for Week 32 Change from Baseline.|Mixed Models Analysis|Mixed Model Analysis: Change in Blood Glucose = Treatment + Baseline + Country + HbA1c stratum + Sulfonylurea use + Visit + Treatment\*Visit||||||0.814
72406867|NCT00548808|144322318|SUPERIORITY_OR_OTHER|||||||0.582||95.0||||P-value for 48 Week Change from Baseline.|Mixed Models Analysis|Mixed Model Analysis: Change in Blood Glucose = Treatment + Baseline + Country + HbA1c stratum + Sulfonylurea use + Visit + Treatment\*Visit||||||0.582
72406868|NCT00548808|144322321|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.08||0.162|TWO_SIDED|95.0|-0.26|0.04||P-value for Cholesterol.|ANCOVA|ANCOVA model: Lab Result = Treatment + Baseline + Country + HbA1c stratum + Sulfonylurea use (Type III sums of squares).|Least Squares Mean Difference = Insulin Lispro LM minus Insulin Glargine.|||0.04|-0.26|0.162
72406869|NCT00548808|144322321|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.09||0.165|TWO_SIDED|95.0|-0.3|0.05||P-value for Triglycerides.|ANCOVA|ANCOVA model: Lab Result = Treatment + Baseline + Country + HbA1c stratum + Sulfonylurea use (Type III sums of squares).|Least Squares Mean Difference = Insulin Lispro LM minus Insulin Glargine.|||0.05|-0.30|0.165
72406870|NCT00548808|144322321|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.07||0.51|TWO_SIDED|95.0|-0.18|0.09||P-value for Low Density Lipoprotein.|ANCOVA|ANCOVA model: Lab Result = Treatment + Baseline + Country + HbA1c stratum + Sulfonylurea use (Type III sums of squares).|Least Squares Mean Difference = Insulin Lispro LM minus Insulin Glargine.|||0.09|-0.18|0.510
72525982|NCT00515099|144582540|SUPERIORITY_OR_OTHER|||||||0.38|TWO_SIDED|||||P-value is for testing treatment effect using an analysis of covariance with baseline In(AUC+1) as a covariate and change in In(AUC+1) from baseline as the outcome variable|ANCOVA|||2-Hour AUC change from baseline (pre-initiation treatment) to Month 24. Primary imputation method used for missing Month 24 AUC. Measuring range for C-peptide is 0.05-30 ng/mL.||||0.38
72525983|NCT00515099|144582540|SUPERIORITY_OR_OTHER|||||||0.33|TWO_SIDED|||||P-value is for testing treatment effect using an analysis of covariance with baseline In(AUC+1) as a covariate and change in In(AUC+1) from baseline as the outcome variable|ANCOVA|||4-Hour AUC change from baseline (pre-initiation treatment) to Month 24. Missing Month 24 AUC values were not imputed. Measuring range for C-peptide is 0.05-30 ng/mL.||||0.33
72406871|NCT00548808|144322321|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.02|STANDARD_ERROR_OF_MEAN|0.02||0.382|TWO_SIDED|95.0|-0.02|0.06||P-value for High Density Lipoprotein.|ANCOVA|ANCOVA model: Lab Result = Treatment + Baseline + Country + HbA1c stratum + Sulfonylurea use (Type III sums of squares).|Least Squares Mean Difference = Insulin Lispro LM minus Insulin Glargine.|||0.06|-0.02|0.382
72406872|NCT01110915|144322426|SUPERIORITY_OR_OTHER||Percentage|0.0|||<|0.0001|ONE_SIDED|97.5||2.5||A priori threshold for statistical significance was 0.025|exact test of binomial proportions|||Null Hypothesis: MRI-related complication rate between the MRI scan and one-month post-MRI \>=10%.||2.5||<0.0001
72525984|NCT00515099|144582541|SUPERIORITY_OR_OTHER|||||||0.07|TWO_SIDED|||||P-value is for testing treatment effect using an analysis of covariance with baseline level as a covariate and change in HbA1c from baseline as the outcome variable|ANCOVA|||Comparison of groups for change from Baseline to Month 12||||0.07
72525985|NCT00515099|144582541|SUPERIORITY_OR_OTHER|||||||0.16|TWO_SIDED|||||P-value is for testing treatment effect using an analysis of covariance with baseline level as a covariate and change in HbA1c from baseline as the outcome variable|ANCOVA|||Comparison of groups for change from Baseline to Month 24||||0.16
72406873|NCT01110915|144322427|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin was 10%.|Difference in percentages|0.0|||||||||||Farrington-Manning test|A priori threshold for statistical significance was 0.025. Because there were no failures in either group, a p-value could not be calculated.||Null hypothesis: % successes MRI group ≤ % successes Control group -10%.||||
72525986|NCT03676465|144582560|SUPERIORITY||||||>|0.05||||||Calculated p value was \>0.05|t-test, 2 sided|||||||>0.05
72525987|NCT03676465|144582561|SUPERIORITY||||||>|0.05||||||Calculated p value was \>0.05|t-test, 2 sided|||||||>0.05
72525988|NCT03676465|144582562|SUPERIORITY||||||>|0.05||||||Calculated p value was \>0.05|t-test, 2 sided|||||||>0.05
72406874|NCT01110915|144322428|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin was 10%.|Difference in percentages|0.5|||<|0.0001|TWO_SIDED|95.0|-5.0|5.9||A priori threshold for statistical significance was 0.025.|Farrington-Manning test|||Null hypothesis: % successes MRI group ≤ % successes Control group -10%.||5.9|-5.0|<0.0001
72406875|NCT01110915|144322429|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin was 10%.|Difference in percentages|1.5||||0.001|ONE_SIDED|95.0|-6.1|||A priori threshold for statistical significance was 0.05.|Farrington-Manning test|||Null hypothesis: % successes MRI group ≤ % successes Control group - 10%.|||-6.1|0.0010
72525989|NCT03676465|144582563|SUPERIORITY||||||>|0.05||||||Calculated p value was \>0.05|t-test, 2 sided|||||||>0.05
72525990|NCT03676465|144582564|SUPERIORITY||||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||||||>0.05
72525991|NCT03676465|144582565|SUPERIORITY||||||>|0.05||||||Calculated p value was \>0.05|t-test, 2 sided|||||||>0.05
72525992|NCT03676465|144582566|SUPERIORITY||||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||||||>0.05
72525993|NCT03676465|144582567|SUPERIORITY||||||>|0.05||||||Calculated p value was \>0.05|t-test, 2 sided|||||||>0.05
72525994|NCT03676465|144582568|SUPERIORITY||||||>|0.05||||||Calculated p value was \>0.05|t-test, 2 sided|||||||>0.05
72525995|NCT03676465|144582569|SUPERIORITY||||||>|0.05||||||Calculated p value was \>0.05|Wilcoxon (Mann-Whitney)|||||||>0.05
72406876|NCT01110915|144322430|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin was 10%.|Difference in percentages|0.1||||0.0001|ONE_SIDED|95.0|-4.6|||A priori threshold for statistical significance was 0.05.|Farrington-Manning test|||Null hypothesis: % successes MRI group ≤ % successes Control group - 10%.|||-4.6|0.0001
72525996|NCT03676465|144582570|SUPERIORITY||||||>|0.05||||||Calculated p value was \>0.05|t-test, 2 sided|||||||>0.05
72525997|NCT03676465|144582571|SUPERIORITY||||||>|0.05||||||Calculated p value was \>0.05|Wilcoxon (Mann-Whitney)|||||||>0.05
72525998|NCT03676465|144582572|SUPERIORITY||||||>|0.05||||||Calculated p value was \>0.05|Wilcoxon (Mann-Whitney)|||||||>0.05
72525999|NCT03676465|144582573|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
72526000|NCT03685643|144582582|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
72526001|NCT03685643|144582583|SUPERIORITY|||||||0.12|||||||Wilcoxon (Mann-Whitney)|||||||0.12
72526002|NCT03685643|144582584|SUPERIORITY|||||||0.19|||||||Wilcoxon (Mann-Whitney)|||||||0.19
72406877|NCT01110915|144322431|SUPERIORITY_OR_OTHER||Percentage|0.0|||<|0.0001|ONE_SIDED|95.0||1.9||A priori threshold for statistical significance was 0.05.|exact test of binomial proportions|||Null hypothesis: the proportion of subjects with sustained ventricular arrhythmias and asystole during MRI scans \>= 10%.||1.9||<0.0001
72406878|NCT01110915|144322432|SUPERIORITY_OR_OTHER||Complication rate at 4 months|7.7|||<|0.05|ONE_SIDED|95.0||10.9||A priori threshold for statistical significance was 0.05.|Kaplan-Meier method|||Null hypothesis: the system-related complication rate between the implant procedure and the 4-months visit \>= 20%.||10.9||<0.05
72406879|NCT03306264|144322463|EQUIVALENCE|ASTX727 and IV decitabine were to be considered equivalent if the 2-sided 90% confidence interval (CI) of the 5-day AUC0-24 ratio of Least Square Mean (LSM) for oral/IV was contained entirely within the range of 0.80 - 1.25.|Ratio of Geometric LSM|98.93|||||TWO_SIDED|90.0|92.66|105.6|||||Analysis was based on ANOVA model with treatment, cycle, and sequence as fixed effects, and participant nested in sequence as a random effect (ratio is Oral/IV).|MDS or CMML: IV Decitabine Versus MDS or CMML: ASTX727||105.6|92.66|
72406880|NCT03306264|144322463|EQUIVALENCE|ASTX727 and IV decitabine were to be considered equivalent if the 2-sided 90% CI of the 5-day AUC0-24 ratio of LSM for oral/IV was contained entirely within the range of 0.80 - 1.25.|Ratio of Geometric LSM|99.64|||||TWO_SIDED|90.0|91.23|108.8|||||Analysis was based on ANOVA model with treatment, cycle, and sequence as fixed effects, and participant nested in sequence as a random effect (ratio is Oral/IV).|AML: IV Decitabine Versus AML: ASTX727||108.8|91.23|
72406881|NCT03306264|144322469|EQUIVALENCE|ASTX727 and IV decitabine were to be considered equivalent if the 2-sided 90% CI of the 5-day AUC0-inf ratio of LSM for oral/IV was contained entirely within the range of 0.80 - 1.25.|Ratio of Geometric LSM|98.0|||||TWO_SIDED|90.0|91.8|104.6|||||Analysis was based on ANOVA model with treatment, cycle, and sequence as fixed effects, and participant nested in sequence as a random effect (ratio is Oral/IV).|MDS or CMML: IV Decitabine Versus MDS or CMML: ASTX727||104.6|91.80|
72406882|NCT03306264|144322469|EQUIVALENCE|ASTX727 and IV decitabine were to be considered equivalent if the 2-sided 90% CI of the 5-day AUC0-inf ratio of LSM for oral/IV was contained entirely within the range of 0.80 - 1.25.|Ratio of Geometric LSM|99.61|||||TWO_SIDED|90.0|91.2|108.8|||||Analysis was based on ANOVA model with treatment, cycle, and sequence as fixed effects, and participant nested in sequence as a random effect (ratio is Oral/IV).|AML: IV Decitabine Versus AML: ASTX727||108.8|91.20|
72406883|NCT03306264|144322470|EQUIVALENCE|ASTX727 and IV decitabine were to be considered equivalent if the 2-sided 90% CI of the 5-day AUC0-last ratio of LSM for oral/IV was contained entirely within the range of 0.80 - 1.25.|Ratio of Geometric LSM|98.11|||||TWO_SIDED|90.0|91.88|104.8|||||Analysis was based on ANOVA model with treatment, cycle, and sequence as fixed effects, and participant nested in sequence as a random effect (ratio is Oral/IV).|MDS or CMML: IV Decitabine Versus MDS or CMML: ASTX727||104.8|91.88|
72406884|NCT03306264|144322470|EQUIVALENCE|ASTX727 and IV decitabine were to be considered equivalent if the 2-sided 90% CI of the 5-day AUC0-last ratio of LSM for oral/IV was contained entirely within the range of 0.80 - 1.25.|Ratio of Geometric LSM|98.11|||||TWO_SIDED|90.0|89.75|107.2|||||Analysis was based on ANOVA model with treatment, cycle, and sequence as fixed effects, and participant nested in sequence as a random effect (ratio is Oral/IV).|AML: IV Decitabine Versus AML: ASTX727||107.2|89.75|
72406885|NCT03306264|144322471|EQUIVALENCE|ASTX727 and IV decitabine were to be considered equivalent if the 2-sided 90% CI of the 5-day AUC0-8 ratio of LSM for oral/IV was contained entirely within the range of 0.80 - 1.25.|Ratio of Geometric LSM|97.93|||||TWO_SIDED|90.0|91.74|104.5|||||Analysis was based on ANOVA model with treatment, cycle, and sequence as fixed effects, and participant nested in sequence as a random effect (ratio is Oral/IV).|MDS or CMML: IV Decitabine Versus MDS or CMML: ASTX727||104.5|91.74|
72526003|NCT01099761|144582600|SUPERIORITY_OR_OTHER_LEGACY|||||||0.023|TWO_SIDED||||||ANCOVA|||||||0.023
72406886|NCT03306264|144322471|EQUIVALENCE|ASTX727 and IV decitabine were to be considered equivalent if the 2-sided 90% CI of the 5-day AUC0-8 ratio of LSM for oral/IV was contained entirely within the range of 0.80 - 1.25.|Ratio of Geometric LSM|97.55|||||TWO_SIDED|90.0|89.32|106.5|||||Analysis was based on ANOVA model with treatment, cycle, and sequence as fixed effects, and participant nested in sequence as a random effect (ratio is Oral/IV).|AML: IV Decitabine Versus AML: ASTX727||106.5|89.32|
72406887|NCT03037528|144322502|SUPERIORITY|||||||0.214|||||||t-test, 2 sided|||||||.214
72406888|NCT03037528|144322502|SUPERIORITY|||||||0.017|||||||t-test, 2 sided|||||||.017
72406889|NCT03037528|144322502|SUPERIORITY|||||||0.457|||||||t-test, 2 sided|||||||.457
72406890|NCT03037528|144322502|SUPERIORITY|||||||0.58|||||||t-test, 2 sided|||||||.580
72406891|NCT03037528|144322502|SUPERIORITY|||||||0.275|||||||t-test, 2 sided|||||||.275
72526004|NCT01099761|144582600|SUPERIORITY_OR_OTHER_LEGACY|||||||0.012|TWO_SIDED||||||ANCOVA|||||||0.012
72406892|NCT03037528|144322502|SUPERIORITY|||||||0.001|||||||t-test, 2 sided|||||||.001
72406893|NCT03037528|144322502|SUPERIORITY|||||||0.007|||||||t-test, 2 sided|||||||.007
72406894|NCT03037528|144322502|SUPERIORITY|||||||0.142|||||||t-test, 2 sided|||||||.142
72406895|NCT03037528|144322503|SUPERIORITY|||||||0.027|||||||t-test, 2 sided|||||||.027
72406896|NCT03037528|144322503|SUPERIORITY|||||||0|||||||t-test, 2 sided|||||||.000
72406897|NCT03037528|144322503|SUPERIORITY|||||||0.054|||||||t-test, 2 sided|||||||.054
72406898|NCT03037528|144322503|SUPERIORITY|||||||0.014|||||||t-test, 2 sided|||||||.014
72406899|NCT03037528|144322503|SUPERIORITY|||||||0.019|||||||t-test, 2 sided|||||||.019
72406900|NCT03037528|144322503|SUPERIORITY|||||||0.026|||||||t-test, 2 sided|||||||.026
72526005|NCT01099761|144582600|SUPERIORITY_OR_OTHER_LEGACY|||||||0.435|TWO_SIDED||||||ANCOVA|||||||0.435
72526006|NCT01099761|144582601|SUPERIORITY_OR_OTHER_LEGACY|||||||0.039|TWO_SIDED||||||ANCOVA|||||||0.039
72542571|NCT01120600|144614975|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-16.0|||=|0.001|TWO_SIDED|95.0|-25.74|-6.27|||cLDA|||A cLDA method was used for this statistical analysis. The cLDA model included the baseline measurement and all post-baseline percent changes from baseline in the response vector, with fixed effects for treatment, time, geographic region, machine type and treatment-by-time interaction, geographic region-by-time interaction, and machine type-by-time interaction.||-6.27|-25.74|= 0.001
72406901|NCT03037528|144322503|SUPERIORITY|||||||0.013|||||||t-test, 2 sided|||||||.013
72406902|NCT03037528|144322503|SUPERIORITY|||||||0.163|||||||t-test, 2 sided|||||||.163
72406903|NCT03037528|144322504|SUPERIORITY|||||||0.018|||||||t-test, 2 sided|||||||.018
72406904|NCT03037528|144322504|SUPERIORITY|||||||0.004|||||||t-test, 2 sided|||||||.004
72406905|NCT03037528|144322504|SUPERIORITY|||||||0.134|||||||t-test, 2 sided|||||||.134
72406906|NCT03037528|144322504|SUPERIORITY|||||||1|||||||t-test, 2 sided|||||||1.000
72406907|NCT03037528|144322504|SUPERIORITY|||||||0.048|||||||t-test, 2 sided|||||||.048
72526007|NCT03398824|144582620|OTHER|Fanconi Anemia is a rare disease. Therefore, the primary end point of the study was to assess the proportion of subjects with a HR during 6 months of metformin treatment; sample size was calculated assuming that a HR rate \< 20% suggests preliminary efficacy of treatment that warranted additional investigation and, conversely, that the study should be deemed futile if the rate of HR was \<5%.|response rate|30.8|||||TWO_SIDED|90.0|11.3|57.3|||||||Fanconi Anemia is a rare disease. Therefore, the primary end point of the study was to assess the proportion of subjects with a HR during 6 months of metformin treatment; sample size was calculated assuming that a HR rate \>20% suggests preliminary efficacy of treatment that warranted additional investigation and, conversely, that the study should be deemed futile if the rate of HR was \<5%.|57.3|11.3|
72526008|NCT05307523|144582629|OTHER|Paired t-test for normally distributed data Wilcoxon Rank test for the not normally distributed data|||||<|0.05||||||Paired T-test for the normally distributed data and a Wilcoxon Rank test for the non-parametric data were used|Both Paired T-test and Wilcoxon Rank|The data included both normally and not normally distributed data for the baseline, mid-study, and final study assessment points.||||||<0.05
72526009|NCT01045551|144582658|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2||||0.98|TWO_SIDED|||||The a priori threshold for statistical significance was P\<0.05.|t-test, 2 sided|||||||0.98
72526010|NCT01045551|144582659|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.09|STANDARD_DEVIATION|0.9024|||TWO_SIDED|||||||||||||
72526011|NCT04337203|144582665|OTHER|Feasibility study and calculated confidence interval.||||||0.54|||||||Independent samples proportions test|||||||0.54
72526012|NCT01682759|144582691|NON_INFERIORITY_OR_EQUIVALENCE|Omarigliptin was considered non-inferior to glimepiride if the upper bound of the two-sided 95% confidence interval (CI) of the between-treatment difference in least-squares (LS) means for change from baseline in A1C at Week 54 (omarigliptin vs. glimepiride) was lower than 0.35%.|Difference in the least squares means|0.18|||||TWO_SIDED|95.0|0.06|0.3|||||Constrained longitudinal data analysis (cLDA) model including terms for treatment, time, and the interaction of time by treatment, with the constraint that the mean baseline is the same for all treatment groups.|||0.30|0.06|
72526013|NCT01682759|144582692|SUPERIORITY_OR_OTHER||Difference in percentages|-6.9|||||TWO_SIDED|95.0|-13.9|0.1|||||Miettinen \& Nurminen method; the 95% CI was computed only for those endpoints with at least 4 participants having events in one or more treatment groups.|||0.1|-13.9|
72526014|NCT01682759|144582693|SUPERIORITY_OR_OTHER||Difference in percentages|1.1|||||TWO_SIDED|95.0|-1.6|3.8|||||Miettinen \& Nurminen method; the 95% CI was computed only for those endpoints with at least 4 participants having events in one or more treatment groups.|||3.8|-1.6|
72526015|NCT01682759|144582694|SUPERIORITY_OR_OTHER||Difference in the least squares means|5.6|||||TWO_SIDED|95.0|0.1|11.2|||||cLDA model including terms for treatment, time, and the interaction of time by treatment, with the constraint that the mean baseline is the same for all treatment groups|||11.2|0.1|
72526016|NCT01682759|144582695|SUPERIORITY_OR_OTHER||Between-group Rate Difference (%)|-3.7|||||TWO_SIDED|95.0|-10.6|3.3|||||Between-group CIs are calculated via Miettinen \& Nurminen method.|A1C \<6.5%||3.3|-10.6|
72526017|NCT01682759|144582696|SUPERIORITY_OR_OTHER||Difference in percentages|-21.3|||<|0.001|TWO_SIDED|95.0|-26.5|-16.4|||Difference in percentages||Miettinen \& Nurminen method; the 95% CI was computed only for those endpoints with at least 4 participants having events in one or more treatment groups.|||-16.4|-26.5|<0.001
72526018|NCT01682759|144582697|SUPERIORITY_OR_OTHER||Difference in the least squares means|-1.9|||<|0.001|TWO_SIDED|95.0|-2.5|-1.4|||Difference in the least squares means||cLDA model including terms for treatment, time, and the interaction of time by treatment with the constraint that the mean baseline is the same for all treatment groups.|||-1.4|-2.5|<0.001
72526019|NCT01682759|144582698|SUPERIORITY_OR_OTHER||Between-group Rate Difference|-10.3|||||TWO_SIDED|95.0|-17.8|-2.8|||||Between-group CIs are calculated via Miettinen \& Nurminen method.|A1C \< 7.0%||-2.8|-17.8|
72526020|NCT04191096|144582699|OTHER||Hazard Ratio (HR)|1.2||||0.9467|TWO_SIDED|95.0|0.96|1.49||A one-sided p-value was calculated using the log-rank test stratified by prior docetaxel for mHSPC (Yes/No) and presence of high-volume disease (Yes/No) with small strata.|Log Rank||HR and associated 95% Confidence Interval (CI) were calculated using Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by prior docetaxel for mHSPC (Yes/No) and presence of high-volume disease (Yes/No).|||1.49|0.96|0.9467
72571269|NCT00446199|144671206|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||significance level of 1.7% is used to adjust (Bonferroni) for the comparison of three active arms with Placebo.|Wilcoxon/van Elteren|stratification by center||Comparison between DRSP/E2 (0.25mg/0.5mg) and Placebo with respect to a shift in the distribution of the end point. Null hypothesis: The distribution of the change from baseline to week 12 in the number of hot flushes is identical in both arms, alternative: there is a shift in the distribution.||||<0.0001
72571270|NCT00446199|144671206|SUPERIORITY_OR_OTHER|||||||0.0005||95.0||||significance level of 1.7% is used to adjust (Bonferroni) for the comparison of three active arms with Placebo.|Wilcoxon/van Elteren|stratification by center||Comparison between E2 (0.3mg) and Placebo with respect to a shift in the distribution of the end point. Null hypothesis: The distribution of the change from baseline to week 12 in the number of hot flushes is identical in both arms, alternative: there is a shift in the distribution.||||0.0005
72571271|NCT00446199|144671207|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||significance level of 1.7% is used to adjust (Bonferroni) for the comparison of three active arms with Placebo.|Wilcoxon/ van Elteren|stratification by center||Comparison between DRSP/E2 (0.5mg/0.5mg) and Placebo with respect to a shift in the distribution of the end point. Null hypothesis: The distribution of the change from baseline to week 4 in the number of hot flushes is identical in both arms, alternative: there is a shift in the distribution.||||<0.0001
72406908|NCT03037528|144322504|SUPERIORITY|||||||0.066|||||||t-test, 2 sided|||||||.066
72526021|NCT04191096|144582700|OTHER||Hazard Ratio (HR)|1.16||||0.85122|TWO_SIDED|95.0|0.88|1.53||One-sided p-value based on log-rank test stratified by prior docetaxel for mHSPC (Yes vs No) and presence of high-volume disease (Yes vs No) with small strata.|Log Rank||HR and associated 95% Confidence Interval (CI) were calculated using Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by prior docetaxel for mHSPC (Yes/No) and presence of high-volume disease (Yes/No)|||1.53|0.88|0.85122
72526022|NCT04191096|144582701|OTHER||Hazard Ratio (HR)|1.24||||0.97907|TWO_SIDED|95.0|1.01|1.54||One-sided p-value based on log-rank test stratified by prior docetaxel for mHSPC (Yes vs No) and presence of high-volume disease (Yes vs No) with small strata.|Log Rank||HR and associated 95% Confidence Interval (CI) were calculated using Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by prior docetaxel for mHSPC (Yes/No) and presence of high-volume disease (Yes/No)|||1.54|1.01|0.97907
72526023|NCT04191096|144582702|OTHER||Hazard Ratio (HR)|0.89||||0.27202|TWO_SIDED|95.0|0.61|1.3||One-sided p-value based on log-rank test stratified by prior docetaxel for mHSPC (Yes vs No) and presence of high-volume disease (Yes vs No) with small strata.|Log Rank||HR and associated 95% Confidence Interval (CI) were calculated using Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by prior docetaxel for mHSPC (Yes/No) and presence of high-volume disease (Yes/No)|||1.30|0.61|0.27202
72526024|NCT04191096|144582703|OTHER||Hazard Ratio (HR)|0.92||||0.2972|TWO_SIDED|95.0|0.69|1.23||One-sided p-value based on log-rank test stratified by prior docetaxel for mHSPC (Yes vs No) and presence of high-volume disease (Yes vs No) with small strata.|Log Rank||HR and associated 95% Confidence Interval (CI) were calculated using Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by prior docetaxel for mHSPC (Yes/No) and presence of high-volume disease (Yes/No)|||1.23|0.69|0.2972
72526025|NCT04191096|144582704|OTHER||Hazard Ratio (HR)|1.07||||0.6863|TWO_SIDED|95.0|0.81|1.41||One-sided p-value based on log-rank test stratified by prior docetaxel for mHSPC (Yes vs No) and presence of high-volume disease (Yes vs No) with small strata.|Log Rank||HR and associated 95% Confidence Interval (CI) were calculated using Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by prior docetaxel for mHSPC (Yes/No) and presence of high-volume disease (Yes/No)|||1.41|0.81|0.6863
72526026|NCT04191096|144582705|OTHER||Hazard Ratio (HR)|1.15||||0.9235|TWO_SIDED|95.0|0.95|1.39||One-sided p-value based on log-rank test stratified by prior docetaxel for mHSPC (Yes vs No) and presence of high-volume disease (Yes vs No) with small strata.|Log Rank||HR and associated 95% Confidence Interval (CI) were calculated using Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by prior docetaxel for mHSPC (Yes/No) and presence of high-volume disease (Yes/No)|||1.39|0.95|0.9235
72526027|NCT04191096|144582706|OTHER||Hazard Ratio (HR)|1.16||||0.8801|TWO_SIDED|95.0|0.9|1.5||One-sided p-value based on log-rank test stratified by prior docetaxel for mHSPC (Yes vs No) and presence of high-volume disease (Yes vs No) with small strata.|Log Rank||HR and associated 95% Confidence Interval (CI) were calculated using Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by prior docetaxel for mHSPC (Yes/No) and presence of high-volume disease (Yes/No).|||1.50|0.90|0.8801
72526028|NCT04191096|144582707|OTHER||Percent Difference|-2.7||||0.9576|TWO_SIDED|95.0|-5.8|0.4||One-sided p-value based on Miettinen \& Nurminen method stratified by prior docetaxel for mHSPC (Yes/No) and presence of high-volume disease (Yes/No) with small strata.|Miettinen & Nurminen method||Percent difference and associated 95% CI were calculated using Miettinen \& Nurminen method stratified by prior docetaxel for mHSPC (Yes/No) and presence of high-volume disease (Yes/No).|||0.4|-5.8|0.9576
72526029|NCT04191096|144582708|OTHER||Percent difference|-0.8||||0.6053|TWO_SIDED|95.0|-6.3|4.8||One-sided p-value based on Miettinen \& Nurminen method stratified by prior docetaxel for mHSPC (Yes/No) and presence of high-volume disease (Yes/No) with small strata.|Miettinen & Nurminen||Percent difference and associated 95% CI were calculated using Miettinen \& Nurminen method stratified by prior docetaxel for mHSPC (Yes/No) and presence of high-volume disease (Yes/No)|||4.8|-6.3|0.6053
72526030|NCT04191096|144582709|OTHER||Percent difference|-5.6||||0.9105|TWO_SIDED|95.0|-13.7|2.6||One-sided p-value based on Miettinen \& Nurminen method stratified prior docataxel for mHSPC (Yes/No) and presence of high-volume disease (Yes/No) with small strata.|Miettinen & Nurminen||Percent difference and associated 95% CI were calculated using Miettinen \& Nurminen method stratified by prior docataxel for mHSPC (Yes/No) and presence of high-volume disease (Yes/No)|||2.6|-13.7|0.9105
72526032|NCT00908895|144582738|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|70.0|STANDARD_DEVIATION|25.0|<|0.05||95.0|||||Chi-squared|||We assess that 15% is a significative strength difference. According to a 80% study power, a SD at 25% and a 20% lost to follow-up, we found 118 patients for the all study.||||<0.05
72526033|NCT00908895|144582739|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|90.0|STANDARD_DEVIATION|10.0|<|0.05||95.0|80.0|100.0|||Chi-squared|||||100|80|<0.05
72406909|NCT03037528|144322504|SUPERIORITY|||||||0.045|||||||t-test, 2 sided|||||||.045
72526034|NCT00887822|144582743|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.03||||0.8636|TWO_SIDED|95.0|0.75|1.41|||Log Rank|The difference in distribution of survival between the two treatment arms was tested with a two-sided unstratified log-rank test.|The hazard ratio between the two treatment arms was estimated with a univariate Cox's proportional hazards model.|||1.41|0.75|0.8636
72526035|NCT00887822|144582745|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.89||||0.4709|TWO_SIDED|95.0|0.66|1.21|||Log Rank|The difference in distribution of progression-free survival between the two treatment arms was tested with a two-sided unstratified log-rank test.|The hazard ratio between the two treatment arms was estimated with a univariate Cox's proportional hazards model.|||1.21|0.66|0.4709
72406910|NCT03037528|144322504|SUPERIORITY|||||||0.053|||||||t-test, 2 sided|||||||.053
72406911|NCT00308711|144322515|SUPERIORITY_OR_OTHER||Kaplan-Meier|1595.5||||0.974||||||The a priori threshold for statistical significance was 0.05.|Log Rank||This was a Kaplan-Meier analysis of median time to vaginal delivery. Cervidil was compared separately to MVI 100 and MVI 50.|Null hypothesis was that there would be no difference in time to vaginal delivery for MVI 100 compared to time to vaginal delivery for Cervidil.||||0.974
72526036|NCT00887822|144582747|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.84||||0.3685|TWO_SIDED|95.0|0.58|1.22|||Log Rank|The difference in distribution of progression-free survival between the two treatment arms was tested with a two-sided unstratified log-rank test.|The hazard ratio between the two treatment arms was estimated with a univariate Cox's proportional hazards model.|||1.22|0.58|0.3685
72526037|NCT00887822|144582749|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.97||||0.8589|TWO_SIDED|95.0|0.67|1.41|||Log Rank|The difference in distribution of disease progression between the two treatment arms was tested with a two-sided unstratified log-rank test.|The hazard ratio between the two treatment arms was estimated with a univariate Cox's proportional hazards model.|||1.41|0.67|0.8589
72526038|NCT00887822|144582750|SUPERIORITY_OR_OTHER||Difference in Response Rates|7.02||||0.348|TWO_SIDED|95.0|-8.3|22.4|||Chi-squared||Approximate 95% CI for difference of two rates using Hauck-Anderson method|||22.4|-8.3|0.3480
72526039|NCT00887822|144582751|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.53||||0.0462|TWO_SIDED|95.0|0.29|1.0|||Log Rank|The difference in distribution of response between the two treatment arms was tested with a two-sided unstratified log-rank test.|The hazard ratio between the two treatment arms was estimated with a univariate Cox's proportional hazards model.|||1.00|0.29|0.0462
72526040|NCT00887822|144582752|SUPERIORITY_OR_OTHER||Difference in Disease Control Rates|0.45||||0.9426|TWO_SIDED|95.0|-12.4|13.3|||Chi-squared||Approximate 95% CI for difference of two rates using Hauck-Anderson method|||13.3|-12.4|0.9426
72526041|NCT02045979|144582756|NON_INFERIORITY_OR_EQUIVALENCE|PK similarity of the two treatments was to be concluded if the 90% CI for the ratio of adjusted geometric means was within 80.00 - 125.00 percent (%).|ratio of the geometric means|108.62|||||TWO_SIDED|90.0|98.5|119.79|||||An analysis of covariance (ANCOVA) model on the logarithmic scale with fixed effects for treatment and trial site as well as age (as recorded at the time of informed consent) and body weight (as recorded at baseline) as continuous covariates.|||119.79|98.50|
72526042|NCT02045979|144582756|NON_INFERIORITY_OR_EQUIVALENCE|PK similarity of the two treatments was to be concluded if the 90% CI for the ratio of adjusted geometric means was within 80.00 - 125.00 %.|ratio of the geometric means|101.27|||||TWO_SIDED|90.0|92.45|110.94|||||An analysis of covariance (ANCOVA) model on the logarithmic scale with fixed effects for treatment and trial site as well as age (as recorded at the time of informed consent) and body weight (as recorded at baseline) as continuous covariates.|||110.94|92.45|
72526043|NCT02045979|144582756|NON_INFERIORITY_OR_EQUIVALENCE|PK similarity of the two treatments was to be concluded if the 90% CI for the ratio of adjusted geometric means was within 80.00 - 125.00 %.|ratio of the geometric means|94.02|||||TWO_SIDED|90.0|86.01|102.78|||||An analysis of covariance (ANCOVA) model on the logarithmic scale with fixed effects for treatment and trial site as well as age (as recorded at the time of informed consent) and body weight (as recorded at baseline) as continuous covariates.|||102.78|86.01|
72526044|NCT02045979|144582757|NON_INFERIORITY_OR_EQUIVALENCE|PK similarity of the two treatments was to be concluded if the 90% CI for the ratio of adjusted geometric means was within 80.00 - 125.00 %.|ratio of the geometric means|107.32|||||TWO_SIDED|90.0|98.49|116.94|||||An analysis of covariance (ANCOVA) model on the logarithmic scale with fixed effects for treatment and trial site as well as age (as recorded at the time of informed consent) and body weight (as recorded at baseline) as continuous covariates.|||116.94|98.49|
72526045|NCT02045979|144582757|NON_INFERIORITY_OR_EQUIVALENCE|PK similarity of the two treatments was to be concluded if the 90% CI for the ratio of adjusted geometric means was within 80.00 - 125.00 %.|ratio of the geometric means|99.93|||||TWO_SIDED|90.0|92.15|108.37|||||An analysis of covariance (ANCOVA) model on the logarithmic scale with fixed effects for treatment and trial site as well as age (as recorded at the time of informed consent) and body weight (as recorded at baseline) as continuous covariates.|||108.37|92.15|
72526046|NCT02045979|144582757|NON_INFERIORITY_OR_EQUIVALENCE|PK similarity of the two treatments was to be concluded if the 90% CI for the ratio of adjusted geometric means was within 80.00 - 125.00 %.|ratio of the geometric means|93.66|||||TWO_SIDED|90.0|86.76|101.11|||||An analysis of covariance (ANCOVA) model on the logarithmic scale with fixed effects for treatment and trial site as well as age (as recorded at the time of informed consent) and body weight (as recorded at baseline) as continuous covariates.|||101.11|86.76|
72526047|NCT02045979|144582758|NON_INFERIORITY_OR_EQUIVALENCE|PK similarity of the two treatments was to be concluded if the 90% CI for the ratio of adjusted geometric means was within 80.00 - 125.00 %.|ratio of the geometric means|100.85|||||TWO_SIDED|90.0|95.15|106.88|||||An analysis of covariance (ANCOVA) model on the logarithmic scale with fixed effects for treatment and trial site as well as age (as recorded at the time of informed consent) and body weight (as recorded at baseline) as continuous covariates.|||106.88|95.15|
72526048|NCT02045979|144582758|NON_INFERIORITY_OR_EQUIVALENCE|PK similarity of the two treatments was to be concluded if the 90% CI for the ratio of adjusted geometric means was within 80.00 - 125.00 %.|ratio of the geometric means|96.39|||||TWO_SIDED|90.0|91.06|102.03|||||An analysis of covariance (ANCOVA) model on the logarithmic scale with fixed effects for treatment and trial site as well as age (as recorded at the time of informed consent) and body weight (as recorded at baseline) as continuous covariates.|||102.03|91.06|
72526049|NCT02045979|144582758|NON_INFERIORITY_OR_EQUIVALENCE|PK similarity of the two treatments was to be concluded if the 90% CI for the ratio of adjusted geometric means was within 80.00 - 125.00 %.|ratio of the geometric means|95.93|||||TWO_SIDED|90.0|90.83|101.33|||||An analysis of covariance (ANCOVA) model on the logarithmic scale with fixed effects for treatment and trial site as well as age (as recorded at the time of informed consent) and body weight (as recorded at baseline) as continuous covariates.|||101.33|90.83|
72526050|NCT02045979|144582759|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing; two-sided 90% Confidence Interval (CI) for the ratio of adjusted geometric means was calculated.|ratio of the geometric means|98.3|||||TWO_SIDED|90.0|91.54|105.55|||||An analysis of covariance (ANCOVA) model on the logarithmic scale with fixed effects for treatment and trial site as well as age (as recorded at the time of informed consent) and body weight (as recorded at baseline) as continuous covariates.|||105.55|91.54|
72526051|NCT02045979|144582759|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing; two-sided 90% CI for the ratio of adjusted geometric means was calculated.|ratio of the geometric means|96.05|||||TWO_SIDED|90.0|89.27|103.36|||||An analysis of covariance (ANCOVA) model on the logarithmic scale with fixed effects for treatment and trial site as well as age (as recorded at the time of informed consent) and body weight (as recorded at baseline) as continuous covariates.|||103.36|89.27|
72406912|NCT00308711|144322515|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1977.0||||0.011||95.0|1977.0|2253.0|||Log Rank|||||2253|1977|0.011
72526052|NCT02045979|144582759|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing; two-sided 90% CI for the ratio of adjusted geometric means was calculated.|ratio of the geometric means|98.11|||||TWO_SIDED|90.0|91.42|105.27|||||An analysis of covariance (ANCOVA) model on the logarithmic scale with fixed effects for treatment and trial site as well as age (as recorded at the time of informed consent) and body weight (as recorded at baseline) as continuous covariates.|||105.27|91.42|
72526053|NCT02045979|144582760|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing; two-sided 90% CI for the ratio of adjusted geometric means was calculated.|ratio of the geometric means|99.61|||||TWO_SIDED|90.0|93.66|105.94|||||An analysis of covariance (ANCOVA) model on the logarithmic scale with fixed effects for treatment and trial site as well as age (as recorded at the time of informed consent) and body weight (as recorded at baseline) as continuous covariates.|||105.94|93.66|
72526054|NCT02045979|144582760|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing; two-sided 90% CI for the ratio of adjusted geometric means was calculated.|ratio of the geometric means|97.19|||||TWO_SIDED|90.0|91.39|103.35|||||An analysis of covariance (ANCOVA) model on the logarithmic scale with fixed effects for treatment and trial site as well as age (as recorded at the time of informed consent) and body weight (as recorded at baseline) as continuous covariates.|||103.35|91.39|
72526055|NCT02045979|144582760|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing; two-sided 90% CI for the ratio of adjusted geometric means was calculated.|ratio of the geometric means|97.97|||||TWO_SIDED|90.0|92.58|103.68|||||An analysis of covariance (ANCOVA) model on the logarithmic scale with fixed effects for treatment and trial site as well as age (as recorded at the time of informed consent) and body weight (as recorded at baseline) as continuous covariates.|||103.68|92.58|
72526056|NCT02045979|144582761|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing; two-sided 90% CI for the ratio of adjusted geometric means was calculated.|ratio of the geometric means|101.23|||||TWO_SIDED|90.0|95.45|107.36|||||An analysis of covariance (ANCOVA) model on the logarithmic scale with fixed effects for treatment and trial site as well as age (as recorded at the time of informed consent) and body weight (as recorded at baseline) as continuous covariates.|||107.36|95.45|
72526057|NCT02045979|144582761|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing; two-sided 90% CI for the ratio of adjusted geometric means was calculated.|ratio of the geometric means|98.83|||||TWO_SIDED|90.0|93.27|104.72|||||An analysis of covariance (ANCOVA) model on the logarithmic scale with fixed effects for treatment and trial site as well as age (as recorded at the time of informed consent) and body weight (as recorded at baseline) as continuous covariates.|||104.72|93.27|
72526058|NCT02045979|144582761|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing; two-sided 90% CI for the ratio of adjusted geometric means was calculated.|ratio of the geometric means|98.01|||||TWO_SIDED|90.0|93.15|103.11|||||An analysis of covariance (ANCOVA) model on the logarithmic scale with fixed effects for treatment and trial site as well as age (as recorded at the time of informed consent) and body weight (as recorded at baseline) as continuous covariates.|||103.11|93.15|
72526059|NCT02045979|144582762|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing; two-sided 90% CI for the ratio of adjusted geometric means was calculated.|ratio of the geometric means|103.68|||||TWO_SIDED|90.0|97.47|110.29|||||An analysis of covariance (ANCOVA) model on the logarithmic scale with fixed effects for treatment and trial site as well as age (as recorded at the time of informed consent) and body weight (as recorded at baseline) as continuous covariates.|||110.29|97.47|
72526060|NCT02045979|144582762|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing; two-sided 90% CI for the ratio of adjusted geometric means was calculated.|ratio of the geometric means|100.16|||||TWO_SIDED|90.0|94.37|106.29|||||An analysis of covariance (ANCOVA) model on the logarithmic scale with fixed effects for treatment and trial site as well as age (as recorded at the time of informed consent) and body weight (as recorded at baseline) as continuous covariates.|||106.29|94.37|
72526061|NCT02045979|144582762|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing; two-sided 90% CI for the ratio of adjusted geometric means was calculated.|ratio of the geometric means|97.02|||||TWO_SIDED|90.0|92.07|102.24|||||An analysis of covariance (ANCOVA) model on the logarithmic scale with fixed effects for treatment and trial site as well as age (as recorded at the time of informed consent) and body weight (as recorded at baseline) as continuous covariates.|||102.24|92.07|
72526062|NCT02045979|144582763|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing; two-sided 90% CI for the ratio of adjusted geometric means was calculated.|ratio of the geometric means|106.57|||||TWO_SIDED|90.0|99.07|114.63|||||An analysis of covariance (ANCOVA) model on the logarithmic scale with fixed effects for treatment and trial site as well as age (as recorded at the time of informed consent) and body weight (as recorded at baseline) as continuous covariates.|||114.63|99.07|
72526063|NCT02045979|144582763|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing; two-sided 90% CI for the ratio of adjusted geometric means was calculated.|ratio of the geometric means|100.94|||||TWO_SIDED|90.0|94.24|108.12|||||An analysis of covariance (ANCOVA) model on the logarithmic scale with fixed effects for treatment and trial site as well as age (as recorded at the time of informed consent) and body weight (as recorded at baseline) as continuous covariates.|||108.12|94.24|
72526064|NCT02045979|144582763|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing; two-sided 90% CI for the ratio of adjusted geometric means was calculated.|ratio of the geometric means|95.37|||||TWO_SIDED|90.0|89.53|101.6|||||An analysis of covariance (ANCOVA) model on the logarithmic scale with fixed effects for treatment and trial site as well as age (as recorded at the time of informed consent) and body weight (as recorded at baseline) as continuous covariates.|||101.60|89.53|
72526065|NCT02045979|144582764|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing; two-sided 90% CI for the ratio of adjusted geometric means was calculated.|ratio of the geometric means|108.7|||||TWO_SIDED|90.0|98.54|119.9|||||An analysis of covariance (ANCOVA) model on the logarithmic scale with fixed effects for treatment and trial site as well as age (as recorded at the time of informed consent) and body weight (as recorded at baseline) as continuous covariates.|||119.90|98.54|
72526066|NCT02045979|144582764|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing; two-sided 90% CI for the ratio of adjusted geometric means was calculated.|ratio of the geometric means|101.36|||||TWO_SIDED|90.0|92.51|111.05|||||An analysis of covariance (ANCOVA) model on the logarithmic scale with fixed effects for treatment and trial site as well as age (as recorded at the time of informed consent) and body weight (as recorded at baseline) as continuous covariates.|||111.05|92.51|
72526067|NCT02045979|144582764|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing; two-sided 90% CI for the ratio of adjusted geometric means was calculated.|ratio of the geometric means|94.04|||||TWO_SIDED|90.0|86.01|102.82|||||An analysis of covariance (ANCOVA) model on the logarithmic scale with fixed effects for treatment and trial site as well as age (as recorded at the time of informed consent) and body weight (as recorded at baseline) as continuous covariates.|||102.82|86.01|
72526068|NCT02425891|144582766|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.8||||0.0025|TWO_SIDED|95.0|0.69|0.92|||Log Rank|||||0.92|0.69|0.0025
72526069|NCT02425891|144582767|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.62|||<|0.0001|TWO_SIDED|95.0|0.49|0.78|||Log Rank|||||0.78|0.49|<.0001
72526070|NCT02425891|144582768|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.87||||0.077|TWO_SIDED|95.0|0.75|1.02|||Log Rank|||||1.02|0.75|0.0770
72526071|NCT02425891|144582769|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.67||||0.0016|TWO_SIDED|95.0|0.53|0.86|||Log Rank|||||0.86|0.53|0.0016
72526072|NCT02425891|144582770|SUPERIORITY|Stratified Analysis|Difference in Overall Response Rates|10.12||||0.0021|TWO_SIDED|95.0|3.4|16.84|||Cochran-Mantel-Haenszel|||||16.84|3.40|0.0021
72526073|NCT02425891|144582771|SUPERIORITY|Stratified Analysis|Difference in Overall Response Rates|16.3||||0.0016|TWO_SIDED|95.0|5.67|26.92|||Cochran-Mantel-Haenszel|||||26.92|5.67|0.0016
72526074|NCT02425891|144582772|SUPERIORITY|Unstratified Analysis|Hazard Ratio (HR)|0.78||||0.0285|TWO_SIDED|95.0|0.63|0.98|||Log Rank|||||0.98|0.63|0.0285
72526075|NCT02425891|144582773|SUPERIORITY|Unstratified Analysis|Hazard Ratio (HR)|0.6||||0.0047|TWO_SIDED|95.0|0.43|0.86|||Log Rank|||||0.86|0.43|0.0047
72526076|NCT02425891|144582774|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.98||||0.8078|TWO_SIDED|95.0|0.81|1.18|||Log Rank|||||1.18|0.81|0.8078
72526077|NCT02425891|144582775|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.98||||0.8879|TWO_SIDED|95.0|0.73|1.31|||Log Rank|||||1.31|0.73|0.8879
72526078|NCT00416572|144582792|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Regression, Linear|||Comparison between education intervention and the control condition at 4 months post-intervention. The full regression model contained 2 dummy-coded variables (education intervention vs. control condition and nutrition education intervention vs. control condition), and the baseline measure of the outcome.||||> 0.05
72571272|NCT00446199|144671207|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||significance level of 1.7% is used to adjust (Bonferroni) for the comparison of three active arms with Placebo.|Wilcoxon/van Elteren|stratification by center||Comparison between DRSP/E2 (0.25mg/0.5mg) and Placebo with respect to a shift in the distribution of the end point. Null hypothesis: The distribution of the change from baseline to week 4 in the number of hot flushes is identical in both arms, alternative: there is a shift in the distribution.||||<0.0001
72571273|NCT00446199|144671207|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||significance level of 1.7% is used to adjust (Bonferroni) for the comparison of three active arms with Placebo.|Wilcoxon/van Elteren|stratification by center||Comparison between E2 (0.3mg) and Placebo with respect to a shift in the distribution of the end point. Null hypothesis: The distribution of the change from baseline to week 4 in the number of hot flushes is identical in both arms, alternative: there is a shift in the distribution.||||<0.0001
72625296|NCT01098747|144780085|SUPERIORITY_OR_OTHER||Difference in proportion|7.28||||0.047|TWO_SIDED|95.0|1.07|13.48||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||4 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||13.48|1.07|0.047
72526079|NCT00416572|144582792|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Regression, Linear|||Comparison between nutrition education intervention and the control condition at 4 months post-intervention. The full regression model contained 2 dummy-coded variables (education intervention vs. control condition and nutrition education intervention vs. control condition), and the baseline measure of the outcome.||||>0.05
72526080|NCT00416572|144582792|SUPERIORITY_OR_OTHER||standardized beta|-0.12|||=|0.08|TWO_SIDED||||||Regression, Linear|||Comparison between education intervention and the control condition at final follow-up (13 months post-intervention). The full regression model contained 2 dummy-coded variables (education intervention vs. control condition and nutrition education intervention vs. control condition), and the baseline measure of the outcome.||||=0.08
72526081|NCT00416572|144582792|SUPERIORITY_OR_OTHER||standardized beta|-0.23|||<|0.001|TWO_SIDED||||||Regression, Linear|||Comparison between nutrition education intervention and the control condition at final follow-up (13 months post-intervention). The full regression model contained 2 dummy-coded variables (education intervention vs. control condition and nutrition education intervention vs. control condition), and the baseline measure of the outcome.||||<0.001
72526082|NCT00416572|144582793|SUPERIORITY_OR_OTHER||||||>|0.5|||||||Regression, Linear|||Comparison between education intervention and the control condition at 4 months post-intervention. The full regression model contained 2 dummy-coded variables (education intervention vs. control condition and nutrition education intervention vs. control condition), and the baseline measure of the outcome.||||>0.50
72526083|NCT00416572|144582793|SUPERIORITY_OR_OTHER||Standardized beta|0.14|||=|0.04|TWO_SIDED||||||Regression, Linear|||Comparison between nutrition education intervention and the control condition at 4 months post-intervention. The full regression model contained 2 dummy-coded variables (education intervention vs. control condition and nutrition education intervention vs. control condition), and the baseline measure of the outcome.||||=0.04
72526084|NCT00416572|144582793|SUPERIORITY_OR_OTHER||Standardized beta|0.25|||<|0.001|TWO_SIDED||||||Regression, Linear|||Comparison between the education intervention and the control condition at final follow-up (13 months post-intervention). The full regression model contained 2 dummy-coded variables (education intervention vs. control condition and nutrition education intervention vs. control condition), and the baseline measure of the outcome.||||<0.001
72526085|NCT00416572|144582793|SUPERIORITY_OR_OTHER||Standardized beta|0.15|||=|0.02|TWO_SIDED||||||Regression, Linear|||Comparison between nutrition education intervention and the control condition at final follow-up (13 months post-intervention). The full regression model contained 2 dummy-coded variables (education intervention vs. control condition and nutrition education intervention vs. control condition), and the baseline measure of the outcome.||||=0.02
72526086|NCT00416572|144582794|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Regression, Linear|||Comparison between education intervention and the control condition at 4 months post-intervention. The full regression model contained 2 dummy-coded variables (education intervention vs. control condition and nutrition education intervention vs. control condition), and the baseline measure of the outcome||||>.05
72526087|NCT00416572|144582794|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Regression, Linear|||Comparison between nutrition education intervention and the control condition at 4 months post-intervention. The full regression model contained 2 dummy-coded variables (education intervention vs. control condition and nutrition education intervention vs. control condition), and the baseline measure of the outcome.||||>0.05
72526088|NCT00416572|144582794|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Regression, Linear|||Comparison between education intervention and the control condition at final follow-up (13 months post-intervention). The full regression model contained 2 dummy-coded variables (education intervention vs. control condition and nutrition education intervention vs. control condition), and the baseline measure of the outcome.||||>0.05
72526089|NCT00416572|144582794|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Regression, Linear|||Comparison between nutrition education intervention and the control condition at final follow-up (13 months post-intervention). The full regression model contained 2 dummy-coded variables (education intervention vs. control condition and nutrition education intervention vs. control condition), and the baseline measure of the outcome.||||>0.05
72526090|NCT01654224|144582795|NON_INFERIORITY_OR_EQUIVALENCE|An upper bound \>0.67 of the 2-sided 95% CI of the ratio of postvaccination GMTHD to GMTSD indicated noninferiority. A lower bound of ≥1.0 of the 2-sided 95% CI of the ratio of GMTHD to GMTSD indicated superiority.||||||0.005||||||A/California/07/2009(H1N1)|t-test, 2 sided|||||||.005
72526091|NCT01654224|144582795|NON_INFERIORITY_OR_EQUIVALENCE|An upper bound \>0.67 of the 2-sided 95% CI of the ratio of postvaccination GMTHD to GMTSD indicated noninferiority. A lower bound of ≥1.0 of the 2-sided 95% CI of the ratio of GMTHD to GMTSD indicated superiority.||||||0.001||||||A/Victoria/210/2009(H3N2)|t-test, 2 sided|||||||.001
72526092|NCT01654224|144582795|NON_INFERIORITY_OR_EQUIVALENCE|An upper bound \>0.67 of the 2-sided 95% CI of the ratio of postvaccination GMTHD to GMTSD indicated noninferiority. A lower bound of ≥1.0 of the 2-sided 95% CI of the ratio of GMTHD to GMTSD indicated superiority.||||||0.004||||||B/Brisbane/60/2008|t-test, 2 sided|||||||.004
72526093|NCT01654224|144582795|NON_INFERIORITY_OR_EQUIVALENCE|An upper bound \>0.67 of the 2-sided 95% CI of the ratio of postvaccination GMTHD to GMTSD indicated noninferiority. A lower bound of ≥1.0 of the 2-sided 95% CI of the ratio of GMTHD to GMTSD indicated superiority.||||||0.672||||||A/California/07/2009(H1N1)|t-test, 2 sided|||||||.672
72526094|NCT01654224|144582795|NON_INFERIORITY_OR_EQUIVALENCE|An upper bound \>0.67 of the 2-sided 95% CI of the ratio of postvaccination GMTHD to GMTSD indicated noninferiority. A lower bound of ≥1.0 of the 2-sided 95% CI of the ratio of GMTHD to GMTSD indicated superiority.||||||0.011||||||A/Victoria/361/2011(H3N2)|t-test, 2 sided|||||||.011
72526095|NCT01654224|144582795|NON_INFERIORITY_OR_EQUIVALENCE|An upper bound \>0.67 of the 2-sided 95% CI of the ratio of postvaccination GMTHD to GMTSD indicated noninferiority. A lower bound of ≥1.0 of the 2-sided 95% CI of the ratio of GMTHD to GMTSD indicated superiority.||||||0.01||||||B/Texas/6/2011|t-test, 2 sided|||||||.010
72526096|NCT01654224|144582796|NON_INFERIORITY_OR_EQUIVALENCE|An upper bound \>0.67 of the 2-sided 95% CI of the ratio of postvaccination GMTHD to GMTSD indicated noninferiority. A lower bound of ≥1.0 of the 2-sided 95% CI of the ratio of GMTHD to GMTSD indicated superiority.||||||0.074||||||A/California/07/2009(H1N1)|t-test, 2 sided|||||||.074
72526097|NCT01654224|144582796|NON_INFERIORITY_OR_EQUIVALENCE|An upper bound \>0.67 of the 2-sided 95% CI of the ratio of postvaccination GMTHD to GMTSD indicated noninferiority. A lower bound of ≥1.0 of the 2-sided 95% CI of the ratio of GMTHD to GMTSD indicated superiority.||||||0.006||||||A/Victoria/210/2009(H3N2)|t-test, 2 sided|||||||.006
72526098|NCT01654224|144582796|NON_INFERIORITY_OR_EQUIVALENCE|An upper bound \>0.67 of the 2-sided 95% CI of the ratio of postvaccination GMTHD to GMTSD indicated noninferiority. A lower bound of ≥1.0 of the 2-sided 95% CI of the ratio of GMTHD to GMTSD indicated superiority.||||||0.069||||||B/Brisbane/60/2008|t-test, 2 sided|||||||.069
72526099|NCT01654224|144582796|NON_INFERIORITY_OR_EQUIVALENCE|An upper bound \>0.67 of the 2-sided 95% CI of the ratio of postvaccination GMTHD to GMTSD indicated noninferiority. A lower bound of ≥1.0 of the 2-sided 95% CI of the ratio of GMTHD to GMTSD indicated superiority.||||||0.663||||||A/California/07/2009(H3N2)|t-test, 2 sided|||||||.663
72526100|NCT01654224|144582796|NON_INFERIORITY_OR_EQUIVALENCE|An upper bound \>0.67 of the 2-sided 95% CI of the ratio of postvaccination GMTHD to GMTSD indicated noninferiority. A lower bound of ≥1.0 of the 2-sided 95% CI of the ratio of GMTHD to GMTSD indicated superiority.||||||0.003||||||A/Victoria/361/2011(H3N2)|t-test, 2 sided|||||||.003
72526101|NCT01654224|144582796|NON_INFERIORITY_OR_EQUIVALENCE|An upper bound \>0.67 of the 2-sided 95% CI of the ratio of postvaccination GMTHD to GMTSD indicated noninferiority. A lower bound of ≥1.0 of the 2-sided 95% CI of the ratio of GMTHD to GMTSD indicated superiority.||||||0.063||||||B/Texas/6/2011|t-test, 2 sided|||||||.063
72526102|NCT01654224|144582797|NON_INFERIORITY_OR_EQUIVALENCE|An upper bound \>0.67 of the 2-sided 95% CI of the ratio of postvaccination GMTHD to GMTSD indicated noninferiority. A lower bound of ≥1.0 of the 2-sided 95% CI of the ratio of GMTHD to GMTSD indicated superiority.||||||0.917||||||A/California/07/2009(H1N1)|t-test, 2 sided|||||||.917
72526103|NCT01654224|144582797|NON_INFERIORITY_OR_EQUIVALENCE|An upper bound \>0.67 of the 2-sided 95% CI of the ratio of postvaccination GMTHD to GMTSD indicated noninferiority. A lower bound of ≥1.0 of the 2-sided 95% CI of the ratio of GMTHD to GMTSD indicated superiority.||||||0.36||||||A/Victoria/210/2009(H3N2)|t-test, 2 sided|||||||.360
72625297|NCT01098747|144780085|SUPERIORITY_OR_OTHER||Difference in proportion|72.61|||<|0.001|TWO_SIDED|95.0|61.05|84.17||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||5 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||84.17|61.05|<0.001
72526104|NCT01654224|144582797|NON_INFERIORITY_OR_EQUIVALENCE|An upper bound \>0.67 of the 2-sided 95% CI of the ratio of postvaccination GMTHD to GMTSD indicated noninferiority. A lower bound of ≥1.0 of the 2-sided 95% CI of the ratio of GMTHD to GMTSD indicated superiority.||||||0.248||||||B/Brisbane/60/2008|t-test, 2 sided|||||||.248
72526105|NCT01654224|144582797|NON_INFERIORITY_OR_EQUIVALENCE|An upper bound \>0.67 of the 2-sided 95% CI of the ratio of postvaccination GMTHD to GMTSD indicated noninferiority. A lower bound of ≥1.0 of the 2-sided 95% CI of the ratio of GMTHD to GMTSD indicated superiority.||||||0.178||||||A/California/07/2009(H1N1)|t-test, 2 sided|||||||.178
72526106|NCT01654224|144582797|NON_INFERIORITY_OR_EQUIVALENCE|An upper bound \>0.67 of the 2-sided 95% CI of the ratio of postvaccination GMTHD to GMTSD indicated noninferiority. A lower bound of ≥1.0 of the 2-sided 95% CI of the ratio of GMTHD to GMTSD indicated superiority.||||||0.152||||||A/Victoria/361/2011(H1N2)|t-test, 2 sided|||||||.152
72526107|NCT01654224|144582797|NON_INFERIORITY_OR_EQUIVALENCE|An upper bound \>0.67 of the 2-sided 95% CI of the ratio of postvaccination GMTHD to GMTSD indicated noninferiority. A lower bound of ≥1.0 of the 2-sided 95% CI of the ratio of GMTHD to GMTSD indicated superiority.||||||0.285||||||B/Texas/6/2011|t-test, 2 sided|||||||.285
72526108|NCT00166504|144582798|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-10.0|STANDARD_DEVIATION|15.3|<|0.001||95.0|-14.3|-5.7|||ANOVA||Direction of the Comparison: Vytorin minus Atorvastatin.|||-5.7|-14.3|<0.001
72526109|NCT02943577|144582828|SUPERIORITY||Least Squares Mean Difference|-1.0||||0.2398|TWO_SIDED|95.0|-2.7|0.68|||Mixed Model Repeated Measures (MMRM)|||||0.68|-2.70|0.2398
72526110|NCT02943577|144582829|SUPERIORITY||Least Squares Mean Difference|0.4||||0.5522|TWO_SIDED|95.0|-0.95|1.77|||Mixed Model Repeated Measures (MMRM)|||||1.77|-0.95|0.5522
72526111|NCT02943577|144582830|SUPERIORITY||Least Squares Mean Difference|0.0||||0.9901|TWO_SIDED|95.0|-2.01|1.99|||Mixed Model Repeated Measures (MMRM)|||||1.99|-2.01|0.9901
72526112|NCT02943577|144582831|SUPERIORITY||Least Squares Mean Difference|0.5||||0.5563|TWO_SIDED|95.0|-1.17|2.17|||Mixed Model Repeated Measures (MMRM)|||||2.17|-1.17|0.5563
72526113|NCT01355224|144582832|SUPERIORITY_OR_OTHER|||||||0.015|||||||Regression, Linear|Adjusted for age, gender, BMI, baseline intention.||||||.0150
72526114|NCT01355224|144582833|SUPERIORITY_OR_OTHER|||||||0.0365|||||||Regression, Linear|Adjusted for age, gender, BMI, and baseline intent.||||||0.0365
72625298|NCT01098747|144780085|SUPERIORITY_OR_OTHER||Difference in proportion|7.28||||0.047|TWO_SIDED|95.0|1.07|13.48||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||5 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||13.48|1.07|0.047
72526115|NCT01355224|144582834|SUPERIORITY_OR_OTHER|||||||0.0622|||||||Regression, Linear|Adjusted for age, gender, BMI, and baseline intent.||||||0.0622
72526116|NCT04654468|144582840|SUPERIORITY||||||<|0.0001|||||||Paired McNemar|||Percentage of participants who achieved TA from baseline through Week 25 were compared with the percentage of participants who reported TA within 24 weeks prior to screening.||||<.0001
72526117|NCT04566445|144582929|SUPERIORITY||LS Mean Difference|0.062|STANDARD_ERROR_OF_MEAN|0.0901|||TWO_SIDED|90.0|-0.087|0.211|||mixed model repeated measures|||Week 12||0.211|-0.087|
72526118|NCT04566445|144582929|SUPERIORITY||LS Mean Difference|0.084|STANDARD_ERROR_OF_MEAN|0.091|||TWO_SIDED|90.0|-0.066|0.234|||mixed model repeated measures|||Week 12||0.234|-0.066|
72526119|NCT04566445|144582929|SUPERIORITY||LS Mean Difference|0.096|STANDARD_ERROR_OF_MEAN|0.1198|||TWO_SIDED|90.0|-0.102|0.294|||mixed model repeated measures|||Week 24||0.294|-0.102|
72526120|NCT04566445|144582929|SUPERIORITY||LS Mean Difference|0.205|STANDARD_ERROR_OF_MEAN|0.12|||TWO_SIDED|90.0|0.007|0.404|||mixed model repeated measures|||Week 24||0.404|0.007|
72526121|NCT04566445|144582929|SUPERIORITY||LS Mean Difference|0.197|STANDARD_ERROR_OF_MEAN|0.2135|||TWO_SIDED|90.0|-0.155|0.55|||mixed model repeated measures|||Week 36||0.550|-0.155|
72526122|NCT04566445|144582929|SUPERIORITY||LS Mean Difference|0.423|STANDARD_ERROR_OF_MEAN|0.2152|||TWO_SIDED|90.0|0.068|0.779|||mixed model repeated measures|||Week 36||0.779|0.068|
72526123|NCT04566445|144582929|SUPERIORITY||LS Mean Difference|0.052|STANDARD_ERROR_OF_MEAN|0.2644|||TWO_SIDED|90.0|-0.385|0.489|||mixed model repeated measures|||Week 48||0.489|-0.385|
72526124|NCT04566445|144582929|SUPERIORITY||LS Mean Difference|0.488|STANDARD_ERROR_OF_MEAN|0.2662|||TWO_SIDED|90.0|0.049|0.928|||mixed model repeated measures|||Week 48||0.928|0.049|
72526125|NCT04566445|144582929|SUPERIORITY||LS Mean Difference|0.307|STANDARD_ERROR_OF_MEAN|0.3361|||TWO_SIDED|90.0|-0.248|0.862|||mixed model repeated measures|||Week 72||0.862|-0.248|
72526126|NCT04566445|144582929|SUPERIORITY||LS Mean Difference|0.503|STANDARD_ERROR_OF_MEAN|0.3392|||TWO_SIDED|90.0|-0.058|1.063|||mixed model repeated measures|||Week 72||1.063|-0.058|
72526127|NCT04566445|144582930|SUPERIORITY||LS Mean Difference|0.645|STANDARD_ERROR_OF_MEAN|0.4527|||TWO_SIDED|90.0|-0.103|1.393|||mixed model repeated measures|||Week 96||1.393|-0.103|
72526128|NCT04566445|144582930|SUPERIORITY||LS Mean Difference|0.838|STANDARD_ERROR_OF_MEAN|0.4577|||TWO_SIDED|90.0|0.081|1.594|||mixed model repeated measures|||Week 96||1.594|0.081|
72526129|NCT04566445|144582935|SUPERIORITY||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|1.33|||TWO_SIDED|90.0|-2.6|1.7|||mixed model repeated measures|||Week 12||1.7|-2.6|
72526130|NCT04566445|144582935|SUPERIORITY||LS Mean Difference|-1.8|STANDARD_ERROR_OF_MEAN|1.32|||TWO_SIDED|90.0|-4.0|0.4|||mixed model repeated measures|||Week 12||0.4|-4.0|
72526131|NCT04566445|144582935|SUPERIORITY||LS Mean Difference|-1.6|STANDARD_ERROR_OF_MEAN|1.5|||TWO_SIDED|90.0|-4.1|0.8|||mixed model repeated measures|||Week 24||0.8|-4.1|
72526132|NCT04566445|144582935|SUPERIORITY||LS Mean Difference|-5.3|STANDARD_ERROR_OF_MEAN|1.49|||TWO_SIDED|90.0|-7.7|-2.8|||mixed model repeated measures|||Week 24||-2.8|-7.7|
72526133|NCT04566445|144582935|SUPERIORITY||LS Mean Difference|0.5|STANDARD_ERROR_OF_MEAN|1.81|||TWO_SIDED|90.0|-2.5|3.5|||mixed model repeated measures|||Week 36||3.5|-2.5|
72526134|NCT04566445|144582935|SUPERIORITY||LS Mean Difference|-4.7|STANDARD_ERROR_OF_MEAN|1.8|||TWO_SIDED|90.0|-7.7|-1.7|||mixed model repeated measures|||Week 36||-1.7|-7.7|
72526135|NCT04566445|144582935|SUPERIORITY||LS Mean Difference|2.6|STANDARD_ERROR_OF_MEAN|2.14|||TWO_SIDED|90.0|-0.9|6.1|||mixed model repeated measures|||Week 48||6.1|-0.9|
72526136|NCT04566445|144582935|SUPERIORITY||LS Mean Difference|-2.1|STANDARD_ERROR_OF_MEAN|2.12|||TWO_SIDED|90.0|-5.6|1.4|||mixed model repeated measures|||Week 48||1.4|-5.6|
72406913|NCT00308711|144322516|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority (NI) margin was within 15% relative to the rate of cesarean section for the comparator (Cervidil 10 mg dinoprostone vaginal insert).|Cox Proportional Hazard|27.8||||0.64||95.0|23.61|32.31|||Fisher Exact|||||32.31|23.61|0.64
72526137|NCT04566445|144582935|SUPERIORITY||LS Mean Difference|4.7|STANDARD_ERROR_OF_MEAN|2.24|||TWO_SIDED|90.0|1.0|8.4|||mixed model repeated measures|||Week 72||8.4|1.0|
72526138|NCT04566445|144582935|SUPERIORITY||LS Mean Difference|0.9|STANDARD_ERROR_OF_MEAN|2.2|||TWO_SIDED|90.0|-2.8|4.5|||mixed model repeated measures|||Week 72||4.5|-2.8|
72526139|NCT04566445|144582935|SUPERIORITY||LS Mean Difference|7.1|STANDARD_ERROR_OF_MEAN|2.7|||TWO_SIDED|90.0|2.7|11.6|||mixed model repeated measures|||Week 96||11.6|2.7|
72526140|NCT04566445|144582935|SUPERIORITY||LS Mean Difference|2.6|STANDARD_ERROR_OF_MEAN|2.68|||TWO_SIDED|90.0|-1.8|7.1|||mixed model repeated measures|||Week 96||7.1|-1.8|
72526141|NCT02421939|144582940|OTHER||Hazard Ratio (HR)|0.637||||0.0004|TWO_SIDED|95.0|0.49|0.83||1-sided P-value|Log Rank||Based on Cox proportional hazards model. Assuming proportional hazards, an HR of \< 1 indicates a reduction in the hazard rate in favor of the gilteritinib arm|Stratified analysis where tratification factors were response to first-line AML therapy and preselected salvage chemotherapy per IRT.||0.830|0.490|0.0004
72571274|NCT00446199|144671208|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||significance level of 1.7% is used to adjust (Bonferroni) for the comparison of three active arms with Placebo.|Wilcoxon/van Elteren|stratification by center||Comparison between DRSP/E2 (0.5mg/0.5mg) and Placebo with respect to a shift in the distribution of the end point. Null hypothesis: The distribution of the change from baseline to week 12 in the mean daily severity of hot flushes is identical in both arms, alternative: there is a shift in the distribution.||||<0.0001
72571275|NCT00446199|144671208|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||significance level of 1.7% is used to adjust (Bonferroni) for the comparison of three active arms with Placebo.|Wilcoxon/van Elteren|stratification by center||Comparison between DRSP/E2 (0.25mg/0.5mg) and Placebo with respect to a shift in the distribution of the end point. Null hypothesis: The distribution of the change from baseline to week 12 in the mean daily severity of hot flushes is identical in both arms, alternative: there is a shift in the distribution.||||<0.0001
72406914|NCT00308711|144322516|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin was rate of cearean section within 15% of Cervidil rate.|Cox Proportional Hazard|28.0||||0.59||95.0|23.86|32.42|||Fisher Exact|||||32.42|23.86|0.59
72526142|NCT02421939|144582942|OTHER||Hazard Ratio (HR)|0.793||||0.0415|TWO_SIDED|95.0|0.577|1.089||1-sided P-value|Log Rank||Based on the Cox proportional hazards model. Assuming proportional hazards, an HR of \< 1 indicates a reduction in the hazard rate in favor of the gilteritinib arm.|Stratification factors were response to first-line AML therapy and preselected salvage chemotherapy per IRT||1.089|0.577|0.0415
72526143|NCT02421939|144582943|OTHER||Adjusted Treatment Difference|10.6||||0.0106|TWO_SIDED|95.0|2.8|18.4||Stratified P-value|Cochran-Mantel-Haenszel|||Based on stratified Cochran-Mantel-Haenszel test. Stratification factors were response to first-line AML therapy and preselected salvage chemotherapy per IRT. Treatment difference = gilteritinib -chemotherapy.||18.4|2.8|0.0106
72526144|NCT02421939|144582944|OTHER||Hazard Ratio (HR)|0.889||||0.6654|TWO_SIDED|95.0|0.506|1.563||Unstratified p-value|Log Rank||Based on the Cox proportional hazards model. Assuming proportional hazards, an HR of \< 1 indicates a reduction in the hazard rate in favor of the gilteritinib arm.|The LFS was analyzed for participants who achieved remission using the stratified log-rank test with strata to control for response to first-line AML therapy and preselected salvage chemotherapy. Duration of LFS was based on Kaplan-Meier estimates.||1.563|0.506|0.6654
72526145|NCT02421939|144582945|OTHER||Hazard Ratio (HR)|0.206||||0.1189|TWO_SIDED|95.0|0.022|1.886||Unstratified|Log Rank||Based on Cox proportional hazards model. Assuming proportional hazards, a hazard ratio \< 1 indicates a reduction in hazard rate in favor of gilteritinib arm.|||1.886|0.022|0.1189
72526146|NCT02421939|144582946|OTHER||Treatment difference|32.5|||<|0.0001|TWO_SIDED|95.0|22.3|42.6||Unstratified 2-sided P-value|2-sided Fisher's exact test|||Treatment difference = gilteritinib - chemotherapy. The 95% CIs were asymptotic confidence limits using the normal approximation to the binomial distribution.||42.6|22.3|<0.0001
72526147|NCT02421939|144582947|OTHER||Treatment Difference|10.2||||0.0333|TWO_SIDED|95.0|1.2|19.1||Unstratified 2-sided P-value.|2-sided Fisher's exact test|Treatment difference = gilteritinib - chemotherapy.||||19.1|1.2|0.0333
72526148|NCT02421939|144582948|OTHER||Least Squares Mean Difference|-1.2567||||0|||||||ANCOVA|||C1D8: Using analysis of covariance (ANCOVA) including treatment as a fixed factor, baseline score, response to first-line AML therapy and preselected salvage chemotherapy per IRT as covariates. Least Square (LS) Mean difference was estimated using chemotherapy as control.||||0.0000
72526149|NCT02421939|144582948|OTHER||Least Squares Mean Difference|0.1574||||0.8037|||||||ANCOVA|||C2D1: Using analysis of covariance (ANCOVA) including treatment as a fixed factor, baseline score, response to first-line AML therapy and preselected salvage chemotherapy per IRT as covariates. Least Square (LS) Mean difference was estimated using chemotherapy as control.||||0.8037
72526150|NCT02421939|144582949|OTHER||Adjusted Treatment Difference,|18.6|||<|0.0171|TWO_SIDED|95.0|9.8|27.4||Stratified 1-sided P-value.|Cochran-Mantel-Haenszel|||Based on a stratified Cochran-Mantel-Haenszel test. Stratification factors were response to first-line AML therapy and preselected salvage chemotherapy per IRT. Pooled strata were used as shown in Table 12.3.3.2. Treatment differences were adjusted based on pooled strata. Treatment difference = gilteritinib 120 mg - chemotherapy.||27.4|9.8|<0.0171
72406915|NCT04590495|144322556|SUPERIORITY|||||||0.946|||||||Mann Whitney U Test|||||||0.9460
72406916|NCT04590495|144322557|SUPERIORITY|||||||0.5699|||||||Mann Whitney U Test|||||||0.5699
72406917|NCT04590495|144322558|SUPERIORITY|||||||0.6068|||||||t-test, 2 sided|||||||0.6068
72526151|NCT01029691|144582965|SUPERIORITY|||||||0.45|||||||t-test, 2 sided|||unadjusted systolic blood pressure at baseline between groups||||0.45
72526152|NCT01029691|144582965|SUPERIORITY|||||||0.66|||||||t-test, 2 sided|||Unadjusted diastolic blood pressure at baseline between groups||||0.66
72526153|NCT01029691|144582965|SUPERIORITY|||||||0.61|||||||t-test, 2 sided|||Unadjusted systolic blood pressure at week 1||||0.61
72526154|NCT01029691|144582965|SUPERIORITY|||||||0.75|||||||t-test, 2 sided|||Unadjusted diastolic blood pressure at week 1||||0.75
72526155|NCT01029691|144582966|SUPERIORITY|||||||0.085|||||||Chi-squared|||||||0.085
72526156|NCT01029691|144582967|SUPERIORITY|||||||0.012||||||Unadjusted|t-test, 2 sided|||||||0.012
72526157|NCT01029691|144582971|SUPERIORITY|||||||0.4|||||||Fisher Exact|||||||0.4
72526158|NCT00137267|144583016|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Chi-squared|||||||<0.001
72526159|NCT00137267|144583017|SUPERIORITY_OR_OTHER|||||||0.152|TWO_SIDED||||||Chi-squared|||||||0.152
72571276|NCT00446199|144671208|SUPERIORITY_OR_OTHER|||||||0.0096||95.0||||significance level of 1.7% is used to adjust (Bonferroni) for the comparison of three active arms with Placebo.|Wilcoxon/van Elteren|stratification by center||Comparison between E2 (0.3mg) and Placebo with respect to a shift in the distribution of the end point. Null hypothesis: The distribution of the change from baseline to week 12 in the mean daily severity of hot flushes is identical in both arms, alternative: there is a shift in the distribution.||||0.0096
72571277|NCT00446199|144671209|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Significance level of 1.7% is used to adjust (Bonferroni) for the comparison of three active arms with Placebo.|Wilcoxon/van Elteren|Stratification by center||Comparison between DRSP/E2 (0.5mg/0.5mg) and Placebo with respect to a shift in the distribution of the end point. Null hypothesis: The distribution of the change from baseline to week 4 in the mean daily severity of hot flushes is identical in both arms, alternative: there is a shift in the distribution.||||<0.0001
72526160|NCT02237898|144583219|SUPERIORITY|||||||0.3|||||||Wilcoxon (Mann-Whitney)|||||||0.3
72526161|NCT01855867|144583224|SUPERIORITY|Statistical significance was determined at the alpha 0.05 level. The study regimen completion rates of participants in the current study taking a fixed dose once daily combination of elvitegravir/cobicistat/TDF/FTC were compared to historical controls who used PEP regimens consisting of TDF/FTC daily and raltegravir twice daily, or earlier regimens of twice daily zidovudine (AZT)/lamivudine (3TC) and a protease inhibitor, using chi-square tests for independence.|chi square||||<|0.05||||||Reported p-value was calculated, and is not attempting to indicate the threshold for statistical significance|Chi-squared|||using historical controls||||<0.05
72526162|NCT00678249|144583226|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Regression, Logistic|||||||<0.001
72526163|NCT01708915|144583235|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.362|STANDARD_ERROR_OF_MEAN|0.171|<|0.0001|TWO_SIDED|95.0|-1.699|-1.025||Model included the fixed, categorical effects of treatment, centre, time, treatment-by-time interaction and the continuous covariate of baseline PI.|Restricted Maximum Likelihood (REML)|REML based on Repeated Measures Model, using all Available Longitudinal Pain Intensity Observations at each Post-baseline time up to 8 hours.||||-1.025|-1.699|<0.0001
72526164|NCT01708915|144583235|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.983|STANDARD_ERROR_OF_MEAN|0.173|<|0.0001|TWO_SIDED|95.0|-1.324|-0.642||Model included the fixed, categorical effects of treatment, centre, time, treatment-by-time interaction and the continuous covariate of baseline PI.|Restricted Maximum Likelihood (REML)|REML based on Repeated Measures Model, using all Available Longitudinal Pain Intensity Observations at each Post-baseline time up to 8 hours.||||-0.642|-1.324|<0.0001
72526165|NCT01708915|144583235|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.158|STANDARD_ERROR_OF_MEAN|0.195||0.4171||95.0|-0.541|0.225||Model included the fixed, categorical effects of treatment, centre, time, treatment-by-time interaction and the continuous covariate of baseline PI.|Restricted Maximum Likelihood (REML)|REML based on Repeated Measures Model, using all Available Longitudinal Pain Intensity Observations at each Post-baseline time up to 8 hours.||||0.225|-0.541|0.4171
72526166|NCT01708915|144583236|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.049|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001||95.0|-1.305|-0.793||Model included the fixed, categorical effects of treatment, centre, time, treatment-by-time interaction and the continuous covariate of baseline PI.|Restricted Maximum Likelihood (REML)|REML based on Repeated Measures Model, using all Available Longitudinal Pain Intensity Observations at each Post-baseline time up to 8 hours.||||-0.793|-1.305|<0.0001
72526167|NCT01708915|144583236|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.731|STANDARD_ERROR_OF_MEAN|0.138|<|0.0001||95.0|-1.003|-0.459||Model included the fixed, categorical effects of treatment, centre, time, treatment-by-time interaction and the continuous covariate of baseline PI.|Restricted Maximum Likelihood (REML)|REML based on Repeated Measures Model, using all Available Longitudinal Pain Intensity Observations at each Post-baseline time up to 8 hours.||||-0.459|-1.003|<0.0001
72526168|NCT01708915|144583236|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.058|STANDARD_ERROR_OF_MEAN|0.152||0.7037||95.0|-0.356|0.241||Model included the fixed, categorical effects of treatment, centre, time, treatment-by-time interaction and the continuous covariate of baseline PI.|Restricted Maximum Likelihood (REML)|REML based on Repeated Measures Model, using all Available Longitudinal Pain Intensity Observations at each Post-baseline time up to 8 hours.||||0.241|-0.356|0.7037
72526169|NCT01708915|144583237|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.655|STANDARD_ERROR_OF_MEAN|0.208|<|0.0001||95.0|-2.064|-1.247|||ANCOVA|The statistical model included baseline PI, centre, and treatment.||||-1.247|-2.064|<0.0001
72526170|NCT01708915|144583237|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.169|STANDARD_ERROR_OF_MEAN|0.209|<|0.0001||95.0|-1.578|-0.759|||ANCOVA|The statistical model included baseline PI, centre, and treatment.||||-0.759|-1.578|<0.0001
72526171|NCT01708915|144583237|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.466|STANDARD_ERROR_OF_MEAN|0.209||0.0259||95.0|-0.875|-0.056|||ANCOVA|The statistical model included baseline PI, centre, and treatment.||||-0.056|-0.875|0.0259
72526172|NCT01708915|144583238|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|7.385|||<|0.0001||95.0|4.943|11.032|||Regression, Logistic|The logistic regression model included baseline PI, centre, and treatment.|Odds Ratio was calculated by Nicoboxil/Nonivamide : Placebo. Odds ratios \> 1 favour Nicoboxil/Nonivamide.|||11.032|4.943|<0.0001
72406918|NCT04590495|144322559|SUPERIORITY|||||||0.903|||||||Mann Whitney U Test|||||||0.9030
72406919|NCT04590495|144322560|SUPERIORITY|||||||0.2668|||||||t-test, 2 sided|||||||0.2668
72406920|NCT04590495|144322561|SUPERIORITY|||||||0.8749||||||adjusted for baseline VAMS score|paired t test|||||||0.8749
72406921|NCT04590495|144322562|SUPERIORITY|||||||0.7922||||||adjusted for baseline VAMS score for physical sedation|paired t test|||||||0.7922
72406922|NCT04590495|144322563|SUPERIORITY|||||||0.9925||||||adjusted for baseline SSS score|paired t test|||||||0.9925
72406923|NCT04590495|144322564|SUPERIORITY|||||||0.2628||||||adjusted for baseline score|paired t test|||||||0.2628
72406924|NCT04590495|144322565|SUPERIORITY|||||||0.0347||||||adjusted for baseline scores|paired t test|||||||0.0347
72526173|NCT01708915|144583238|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.62|||<|0.0001||95.0|2.469|5.308|||Regression, Logistic|The logistic regression model included baseline PI, centre, and treatment.|Odds Ratio was calculated by Nicoboxil/Nonivamide : Nicoboxil. Odds ratios \> 1 favour Nicoboxil/Nonivamide.|||5.308|2.469|<0.0001
72526174|NCT01708915|144583238|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.594||||0.0129||95.0|1.104|2.303|||Regression, Logistic|The logistic regression model included baseline PI, centre, and treatment.|Odds Ratio was calculated by Nicoboxil/Nonivamide : Nonivamide. Odds ratios \> 1 favour Nicoboxil/Nonivamide.|||2.303|1.104|0.0129
72526175|NCT04223778|144583244|NON_INFERIORITY|Doravirine/Islatravir (DOR/ISL) - Baseline Antiretroviral Therapy (ART). Non-inferiority was concluded if the upper bound of the 2-sided multiplicity-adjusted 95% CI was less than 4 percentage points.|Estimated Difference|-1.49|||<|0.001|TWO_SIDED|95.0|-3.44|-0.34|||Miettinen and Nurminen|The Miettinen and Nurminen method was stratified by corrected baseline ART regimen with Cochran-Mantel-Haenszel (CMH) weights.||||-0.34|-3.44|<.001
72526176|NCT04223778|144583245|OTHER|Difference in percentage versus Baseline Antiretroviral Therapy (ART). Type of statistical test 'other' denotes no hypothesis testing was conducted.|Estimated Difference|9.8|||||TWO_SIDED|95.0|3.3|16.3|||||Difference in percentage versus (vs) Baseline ART was based on Miettinen \& Nurminen method.|||16.3|3.3|
72526177|NCT04223778|144583246|OTHER|Difference in percentage versus Baseline Antiretroviral Therapy (ART). Type of statistical test 'other' denotes no hypothesis testing was conducted.|Estimated Difference|1.8|||||TWO_SIDED|95.0|0.2|4.0|||||Difference in percentage versus (vs) Baseline ART was based on Miettinen \& Nurminen method.|||4.0|0.2|
72526178|NCT04223778|144583247|OTHER|Doravirine/Islatravir (DOR/ISL)- Baseline Antiretroviral Therapy (ART). Type of statistical test 'other' denotes no hypothesis testing was conducted.|Estimated Difference|0.3|||||TWO_SIDED|95.0|-3.28|3.9|||||The Miettinen and Nurminen method was stratified by corrected baseline ART regimen with Cochran-Mantel-Haenszel (CMH) weights.|HIV-1 RNA \<40 copies/mL||3.90|-3.28|
72526179|NCT04223778|144583247|OTHER|Doravirine/Islatravir (DOR/ISL)- Baseline Antiretroviral Therapy (ART). Type of statistical test 'other' denotes no hypothesis testing was conducted.|Estimated Difference|0.89|||||TWO_SIDED|95.0|-2.58|4.43|||||The Miettinen and Nurminen method was stratified by corrected baseline ART regimen with Cochran-Mantel-Haenszel (CMH) weights.|HIV-1 RNA \<50 copies/mL||4.43|-2.58|
72526180|NCT04223778|144583250|OTHER|Difference in percentage versus Baseline Antiretroviral Therapy (ART). Type of statistical test 'other' denotes no hypothesis testing was conducted.|Estimated Difference|-8.9|||||TWO_SIDED|95.0|-13.4|-4.5|||||Difference in percentage versus (vs) Baseline ART was based on Miettinen \& Nurminen method.|||-4.5|-13.4|
72526181|NCT04223778|144583255|OTHER|Treatment Difference vs Baseline ART. Type of statistical test 'other' denotes no hypothesis testing was conducted.|Estimated Difference|-19.75|||||TWO_SIDED|95.0|-33.07|-6.44|||||Difference in percentage versus (vs) Baseline ART was based on Miettinen \& Nurminen method.|Fasting Cholesterol||-6.44|-33.07|
72406925|NCT04590495|144322566|SUPERIORITY|||||||0.6331||||||adjusted for baseline score|paired t test|||||||0.6331
72406926|NCT04590495|144322567|SUPERIORITY|||||||0.472||||||adjusted for baseline score|paired t test|||||||0.4720
72526182|NCT04223778|144583255|OTHER|Treatment Difference vs Baseline ART. Type of statistical test 'other' denotes no hypothesis testing was conducted.|Estimated Difference|-1.35|||||TWO_SIDED|95.0|-6.55|3.84|||||Difference in percentage versus (vs) Baseline ART was based on Miettinen \& Nurminen method.|Fasting HDL Cholesterol||3.84|-6.55|
72526183|NCT04223778|144583255|OTHER|Treatment Difference vs Baseline ART. Type of statistical test 'other' denotes no hypothesis testing was conducted.|Estimated Difference|-13.94|||||TWO_SIDED|95.0|-24.69|-3.2|||||Difference in percentage versus (vs) Baseline ART was based on Miettinen \& Nurminen method.|Fasting LDL Cholesterol||-3.20|-24.69|
72526184|NCT04223778|144583255|OTHER|Treatment Difference vs Baseline ART. Type of statistical test 'other' denotes no hypothesis testing was conducted.|Estimated Difference|-17.74|||||TWO_SIDED|95.0|-30.02|-5.46|||||Difference in percentage versus (vs) Baseline ART was based on Miettinen \& Nurminen method.|Fasting Non-HDL Cholesterol||-5.46|-30.02|
72406927|NCT04590495|144322568|SUPERIORITY|||||||0.02||||||adjusted for baseline reaction time|paired t test|||||||0.0200
72406928|NCT04590495|144322569|SUPERIORITY|||||||0.062||||||adjusted for baseline reaction time|paired t test|||||||0.0620
72406929|NCT03591575|144322602|SUPERIORITY|||||||0.0446|||||||Fisher Exact|||Patients who reached the serum ferritin threshold at any time point prior to Month 12 were withdrawn from the study as per protocol, so that they could begin on standard chelation therapy. For these individuals, imputed data were used to estimate the values that would likely have been seen at Month 12 had they remained in the study.||||0.0446
72406930|NCT03591575|144322603|SUPERIORITY|||||||0.0446||||||he p-value shown here is for the difference between the groups at Month 12.|Fisher Exact|||||||0.0446
72406931|NCT04487080|144322649|SUPERIORITY||Hazard Ratio (HR)|0.7||||0.0002|TWO_SIDED|95.0|0.58|0.85|||Log Rank||HR and its 95% CI was estimated based on a stratified Cox's regression model with treatment as the sole explanatory variable.|||0.85|0.58|0.0002
72406932|NCT03890367|144322699|NON_INFERIORITY|The two-sided 97.5 percent (%) confidence interval (CI) was calculated based on the Wilson score method without continuity correction. The non-inferiority was demonstrated if the lower limit of the 97.5% CI of the percentage difference between compared groups was greater than (\>) -10%.|Difference in Percentage|10.43|||||TWO_SIDED|97.5|5.68|16.2||||||||16.2|5.68|
72406933|NCT03890367|144322700|NON_INFERIORITY|The two-sided 97.5% CI of the ratio of post-vaccination GMTs was calculated using normal approximation of log-transformed titers. The non-inferiority was demonstrated if the lower limit of the two-sided 97.5% CI of the ratio of GMTs between compared groups was \>1/1.5.|GMT Ratio|16.3|||||TWO_SIDED|97.5|12.7|21.0||||||||21.0|12.7|
72526185|NCT04223778|144583255|OTHER|Treatment Difference vs Baseline ART. Type of statistical test 'other' denotes no hypothesis testing was conducted.|Estimated Difference|-21.28|||||TWO_SIDED|95.0|-45.51|2.96|||||Difference in percentage versus (vs) Baseline ART was based on Miettinen \& Nurminen method.|Fasting Triglycerides||2.96|-45.51|
72526186|NCT04223778|144583256|OTHER|Treatment Difference vs Baseline ART. Type of statistical test 'other' denotes no hypothesis testing was conducted.|Estimated Difference|-4.17|||||TWO_SIDED|95.0|-10.43|2.09|||||Difference in percentage versus (vs) Baseline ART was based on Miettinen \& Nurminen method|Fasting Cholesterol||2.09|-10.43|
72526187|NCT04223778|144583256|OTHER|Treatment Difference vs Baseline ART. Type of statistical test 'other' denotes no hypothesis testing was conducted.|Estimated Difference|0.81|||||TWO_SIDED|95.0|-1.46|3.09|||||Difference in percentage versus (vs) Baseline ART was based on Miettinen \& Nurminen method|Fasting HDL Cholesterol||3.09|-1.46|
72526188|NCT04223778|144583256|OTHER|Treatment Difference vs Baseline ART. Type of statistical test 'other' denotes no hypothesis testing was conducted.|Estimated Difference|-3.87|||||TWO_SIDED|95.0|-9.47|1.74|||||Difference in percentage versus (vs) Baseline ART was based on Miettinen \& Nurminen method|Fasting LDL Cholesterol||1.74|-9.47|
72526189|NCT04223778|144583256|OTHER|Treatment Difference vs Baseline ART. Type of statistical test 'other' denotes no hypothesis testing was conducted.|Estimated Difference|-4.92|||||TWO_SIDED|95.0|-11.21|1.38|||||Difference in percentage versus (vs) Baseline ART was based on Miettinen \& Nurminen method|Fasting Non-HDL Cholesterol||1.38|-11.21|
72526190|NCT04223778|144583256|OTHER|Treatment Difference vs Baseline ART. Type of statistical test 'other' denotes no hypothesis testing was conducted.|Estimated Difference|1.65|||||TWO_SIDED|95.0|-16.14|19.43|||||Difference in percentage versus (vs) Baseline ART was based on Miettinen \& Nurminen method|Fasting Triglycerides||19.43|-16.14|
72526191|NCT04223778|144583257|OTHER|Treatment Difference vs Baseline ART. Type of statistical test 'other' denotes no hypothesis testing was conducted.|Estimated Difference|1.05|||||TWO_SIDED|95.0|-7.6|9.7|||||Difference in percentage versus (vs) Baseline ART was based on Miettinen \& Nurminen method|Fasting Cholesterol||9.70|-7.60|
72526192|NCT04223778|144583257|OTHER|Treatment Difference vs Baseline ART. Type of statistical test 'other' denotes no hypothesis testing was conducted.|Estimated Difference|-3.16|||||TWO_SIDED|95.0|-6.37|0.05|||||Difference in percentage versus (vs) Baseline ART was based on Miettinen \& Nurminen method|Fasting HDL Cholesterol||0.05|-6.37|
72526193|NCT04223778|144583257|OTHER|Treatment Difference vs Baseline ART. Type of statistical test 'other' denotes no hypothesis testing was conducted.|Estimated Difference|4.38|||||TWO_SIDED|95.0|-2.27|11.03|||||Difference in percentage versus (vs) Baseline ART was based on Miettinen \& Nurminen method|Fasting LDL Cholesterol||11.03|-2.27|
72526194|NCT04223778|144583257|OTHER|Treatment Difference vs Baseline ART. Type of statistical test 'other' denotes no hypothesis testing was conducted.|Estimated Difference|3.63|||||TWO_SIDED|95.0|-3.93|11.19|||||Difference in percentage versus (vs) Baseline ART was based on Miettinen \& Nurminen method|Fasting Non-HDL Cholesterol||11.19|-3.93|
72526195|NCT04223778|144583257|OTHER|Treatment Difference vs Baseline ART. Type of statistical test 'other' denotes no hypothesis testing was conducted.|Estimated Difference|-1.79|||||TWO_SIDED|95.0|-15.89|12.31|||||Difference in percentage versus (vs) Baseline ART was based on Miettinen \& Nurminen method|Fasting Triglycerides||12.31|-15.89|
72526196|NCT04223778|144583258|OTHER|Treatment Difference vs Baseline ART. Type of statistical test 'other' denotes no hypothesis testing was conducted.|Estimated Difference|-18.41|||||TWO_SIDED|95.0|-32.05|-4.76|||||Difference in percentage versus (vs) Baseline ART was based on Miettinen \& Nurminen method|Fasting Cholesterol||-4.76|-32.05|
72526197|NCT04223778|144583258|OTHER|Treatment Difference vs Baseline ART. Type of statistical test 'other' denotes no hypothesis testing was conducted.|Estimated Difference|0.01|||||TWO_SIDED|95.0|-5.06|5.08|||||Difference in percentage versus (vs) Baseline ART was based on Miettinen \& Nurminen method|Fasting HDL Cholesterol||5.08|-5.06|
72526198|NCT04223778|144583258|OTHER|Treatment Difference vs Baseline ART. Type of statistical test 'other' denotes no hypothesis testing was conducted.|Estimated Difference|-14.12|||||TWO_SIDED|95.0|-25.81|-2.43|||||Difference in percentage versus (vs) Baseline ART was based on Miettinen \& Nurminen method|Fasting LDL Cholesterol||-2.43|-25.81|
72526199|NCT04223778|144583258|OTHER|Treatment Difference vs Baseline ART. Type of statistical test 'other' denotes no hypothesis testing was conducted.|Estimated Difference|-18.23|||||TWO_SIDED|95.0|-30.45|-6.0|||||Difference in percentage versus (vs) Baseline ART was based on Miettinen \& Nurminen method|Fasting Non-HDL Cholesterol||-6.00|-30.45|
72526200|NCT04223778|144583258|OTHER|Treatment Difference vs Baseline ART. Type of statistical test 'other' denotes no hypothesis testing was conducted.|Estimated Difference|-27.79|||||TWO_SIDED|95.0|-51.08|-4.49|||||Difference in percentage versus (vs) Baseline ART was based on Miettinen \& Nurminen method|Fasting Triglycerides||-4.49|-51.08|
72526201|NCT04223778|144583258|SUPERIORITY|Treatment Difference vs Baseline ART. Superiority will be concluded if the upper bound of the 2-sided multiplicity-adjusted 95% CI is less than 0 percentage points.|Mean Difference (Net)|-14.12||||0.0094|TWO_SIDED|95.0|-27.56|-0.68||The significance level in ANCOVA model was 0.02497/2=0.012485. The p-value is statistically significant if it is \<0.02497/2=0.012485.|ANCOVA|||Fasting LDL Cholesterol - Multiplicity Adjusted|The multiplicity adjusted 95% CIs for treatment difference were calculated from ANCOVA models with terms for baseline measurement and treatment.|-0.68|-27.56|0.0094
72526202|NCT04223778|144583258|SUPERIORITY|Treatment Difference vs Baseline ART. Superiority will be concluded if the upper bound of the 2-sided multiplicity-adjusted 95% CI is less than 0 percentage points.|Mean Difference (Net)|-18.23||||0.0021|TWO_SIDED|95.0|-32.28|-4.17||The significance level in ANCOVA model was 0.02497/2=0.012485. The p-value is statistically significant if it is \<0.02497/2=0.012485.|ANCOVA|||Fasting Non-HDL Cholesterol - Multiplicity Adjusted|The multiplicity adjusted 95% CIs for treatment difference were calculated from ANCOVA models with terms for baseline measurement and treatment.|-4.17|-32.28|0.0021
72526203|NCT04223778|144583259|OTHER|Treatment Difference vs Baseline ART. Type of statistical test 'other' denotes no hypothesis testing was conducted.|Estimated Difference|-0.04|||||TWO_SIDED|95.0|-6.26|6.18|||||Difference in percentage versus (vs) Baseline ART was based on Miettinen \& Nurminen method|Fasting Cholesterol||6.18|-6.26|
72526204|NCT04223778|144583259|OTHER|Treatment Difference vs Baseline ART. Type of statistical test 'other' denotes no hypothesis testing was conducted.|Estimated Difference|0.35|||||TWO_SIDED|95.0|-1.84|2.54|||||Difference in percentage versus (vs) Baseline ART was based on Miettinen \& Nurminen method|Fasting HDL Cholesterol||2.54|-1.84|
72526205|NCT04223778|144583259|OTHER|Treatment Difference vs Baseline ART. Type of statistical test 'other' denotes no hypothesis testing was conducted.|Estimated Difference|0.64|||||TWO_SIDED|95.0|-4.83|6.11|||||Difference in percentage versus (vs) Baseline ART was based on Miettinen \& Nurminen method|Fasting LDL Cholesterol||6.11|-4.83|
72571278|NCT00446199|144671209|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Significance level of 1.7% is used to adjust (Bonferroni) for the comparison of three active arms with Placebo.|Wilcoxon/van Elteren|Stratification by center||Comparison between DRSP/E2 (0.25mg/0.5mg) and Placebo with respect to a shift in the distribution of the end point. Null hypothesis: The distribution of the change from baseline to week 4 in the mean daily severity of hot flushes is identical in both arms, alternative: there is a shift in the distribution.||||<0.0001
72526206|NCT04223778|144583259|OTHER|Treatment Difference vs Baseline ART. Type of statistical test 'other' denotes no hypothesis testing was conducted.|Estimated Difference|-0.49|||||TWO_SIDED|95.0|-6.81|5.83|||||Difference in percentage versus (vs) Baseline ART was based on Miettinen \& Nurminen method|Fasting Non-HDL Cholesterol||5.83|-6.81|
72571279|NCT00446199|144671209|SUPERIORITY_OR_OTHER|||||||0.0005||95.0||||Significance level of 1.7% is used to adjust (Bonferroni) for the comparison of three active arms with Placebo.|Wilcoxon/van Elteren|Stratification by center||Comparison between E2 (0.3mg) and Placebo with respect to a shift in the distribution of the end point. Null hypothesis: The distribution of the change from baseline to week 4 in the mean daily severity of hot flushes is identical in both arms, alternative: there is a shift in the distribution.||||0.0005
72571280|NCT00446199|144671210|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon/van Elteren|Stratification by center||Comparison between DRSP/E2 (0.5mg/0.5mg) and Placebo with respect to a shift in the distribution of the end point. Null hypothesis: The distribution of the change from baseline to week 12 in vaginal pH is identical in both arms, alternative: there is a shift in the distribution.||||<0.0001
72625299|NCT01098747|144780085|SUPERIORITY_OR_OTHER||Difference in proportion|72.61|||<|0.001|TWO_SIDED|95.0|61.05|84.17||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||6 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||84.17|61.05|<0.001
72625300|NCT01098747|144780085|SUPERIORITY_OR_OTHER||Difference in proportion|7.28||||0.047|TWO_SIDED|95.0|1.07|13.48||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||6 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||13.48|1.07|0.047
72625301|NCT01098747|144780085|SUPERIORITY_OR_OTHER||Difference in proportion|72.61|||<|0.001|TWO_SIDED|95.0|61.05|84.17||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||7 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||84.17|61.05|<0.001
72625302|NCT01098747|144780085|SUPERIORITY_OR_OTHER||Difference in proportion|7.28||||0.047|TWO_SIDED|95.0|1.07|13.48||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||7 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||13.48|1.07|0.047
72625303|NCT01098747|144780085|SUPERIORITY_OR_OTHER||Difference in proportion|72.61|||<|0.001|TWO_SIDED|95.0|61.05|84.17||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||8 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||84.17|61.05|<0.001
72625304|NCT01098747|144780085|SUPERIORITY_OR_OTHER||Difference in proportion|7.28||||0.047|TWO_SIDED|95.0|1.07|13.48||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||8 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||13.48|1.07|0.047
72625305|NCT01098747|144780086|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.13|||<|0.001|TWO_SIDED|95.0|0.08|0.22||p-value was calculated using PH model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Proportional hazards model|||HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model.||0.22|0.08|<0.001
72625306|NCT01098747|144780086|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.33||||0.281|TWO_SIDED|95.0|0.79|2.22||p-value was calculated using PH model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Proportional hazards model|||HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model.||2.22|0.79|0.281
72571281|NCT00446199|144671210|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon/van Elteren|Stratification by center||Comparison between DRSP/E2 (0.25mg/0.5mg) and Placebo with respect to a shift in the distribution of the end point. Null hypothesis: The distribution of the change from baseline to week 12 in vaginal pH is identical in both arms, alternative: there is a shift in the distribution.||||<0.0001
72571282|NCT00446199|144671210|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon/van Elteren|Stratification by center||Comparison between E2 (0.3 mg) and Placebo with respect to a shift in the distribution of the end point. Null hypothesis: The distribution of the change from baseline to week 12 in vaginal pH is identical in both arms, alternative: there is a shift in the distribution.||||<0.0001
72526207|NCT04223778|144583259|OTHER|Treatment Difference vs Baseline ART. Type of statistical test 'other' denotes no hypothesis testing was conducted.|Estimated Difference|-5.45|||||TWO_SIDED|95.0|-20.46|9.57|||||Difference in percentage versus (vs) Baseline ART was based on Miettinen \& Nurminen method|Fasting Triglycerides||9.57|-20.46|
72526208|NCT04223778|144583259|SUPERIORITY|Treatment Difference vs Baseline ART. Superiority will be concluded if the upper bound of the 2-sided multiplicity-adjusted 95% CI is less than 0 percentage points.|Mean Difference (Net)|0.64||||0.4093|TWO_SIDED|95.0|-5.63|6.9||The significance level in ANCOVA model was 0.02497/2=0.012485. The p-value is statistically significant if it is \<0.02497/2=0.012485.|ANCOVA|||Fasting LDL Cholesterol - Multiplicity Adjusted|The multiplicity adjusted 95% CIs for treatment difference were calculated from ANCOVA models with terms for baseline measurement and treatment.|6.90|-5.63|0.4093
72526209|NCT04223778|144583259|SUPERIORITY|Treatment Difference vs Baseline ART. Superiority will be concluded if the upper bound of the 2-sided multiplicity-adjusted 95% CI is less than 0 percentage points.|Mean Difference (Net)|-0.49||||0.4397|TWO_SIDED|95.0|-7.72|6.75||The significance level in ANCOVA model was 0.02497/2=0.012485. The p-value is statistically significant if it is \<0.02497/2=0.012485.|ANCOVA|||Fasting Non-HDL Cholesterol - Multiplicity Adjusted|The multiplicity adjusted 95% CIs for treatment difference were calculated from ANCOVA models with terms for baseline measurement and treatment.|6.75|-7.72|0.4397
72526210|NCT04223778|144583260|OTHER|Treatment Difference vs Baseline ART. Type of statistical test 'other' denotes no hypothesis testing was conducted.|Estimated Difference|2.31|||||TWO_SIDED|95.0|-5.54|10.17|||||Difference in percentage versus (vs) Baseline ART was based on Miettinen \& Nurminen method|Fasting Cholesterol||10.17|-5.54|
72526211|NCT04223778|144583260|OTHER|Treatment Difference vs Baseline ART. Type of statistical test 'other' denotes no hypothesis testing was conducted.|Estimated Difference|-2.52|||||TWO_SIDED|95.0|-5.69|0.65|||||Difference in percentage versus (vs) Baseline ART was based on Miettinen \& Nurminen method|Fasting HDL Cholesterol||0.65|-5.69|
72526212|NCT04223778|144583260|OTHER|Treatment Difference vs Baseline ART. Type of statistical test 'other' denotes no hypothesis testing was conducted.|Estimated Difference|2.34|||||TWO_SIDED|95.0|-3.73|8.42|||||Difference in percentage versus (vs) Baseline ART was based on Miettinen \& Nurminen method|Fasting LDL Cholesterol||8.42|-3.73|
72526213|NCT04223778|144583260|OTHER|Treatment Difference vs Baseline ART. Type of statistical test 'other' denotes no hypothesis testing was conducted.|Estimated Difference|3.97|||||TWO_SIDED|95.0|-2.63|10.56|||||Difference in percentage versus (vs) Baseline ART was based on Miettinen \& Nurminen method|Fasting Non-HDL Cholesterol||10.56|-2.63|
72526214|NCT04223778|144583260|OTHER|Treatment Difference vs Baseline ART. Type of statistical test 'other' denotes no hypothesis testing was conducted.|Estimated Difference|10.5|||||TWO_SIDED|95.0|-3.97|24.96|||||Difference in percentage versus (vs) Baseline ART was based on Miettinen \& Nurminen method|Fasting Triglycerides||24.96|-3.97|
72526215|NCT04223778|144583261|OTHER|Treatment Difference vs Baseline ART. Type of statistical test 'other' denotes no hypothesis testing was conducted.|Estimated Difference|0.44|||||TWO_SIDED|95.0|-0.59|1.46|||||Difference in percentage versus (vs) Baseline ART was based on Miettinen \& Nurminen method|||1.46|-0.59|
72571283|NCT00446199|144671211|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon/van Elteren|stratification by center||Comparison between DRSP/E2 (0.5mg/0.5mg) and Placebo with respect to a shift in the distribution of the end point. Null hypothesis: The distribution of the change from baseline to week 12 in vaginal maturation value is identical in both arms, alternative: there is a shift in the distribution.||||<0.0001
72526216|NCT02059174|144583298|NON_INFERIORITY_OR_EQUIVALENCE|A frailty model was used with effects for treatment, period and sequence and a random effect for participant. A value of 1.00 for the hazard ratio corresponds to no difference between treatments.|Hazard Ratio (HR)|1.07|||||TWO_SIDED|95.0|0.72|1.59|||||ratio (MK-1293 / EU-Approved Lantus)|Because numerous participants did not achieve End of Action within the 30-hour clamp timeframe, the pre-specified hypothesis of similarity with regard to mean DOA could not be tested and a survival analysis approach was undertaken. The hazard rate is a measure of the instantaneous risk of reaching End of Action at time t given End of Action has not been met up until time t, with the hazard ratio being an estimate of the relative difference in hazard rates between treatments.||1.59|0.72|
72526217|NCT02059174|144583299|NON_INFERIORITY_OR_EQUIVALENCE|Similarity criteria calculated via Fieller's Theorem was 95% confidence interval for arithmetic mean ratio (MK-1293/EU-Lantus™) falls between 0.80-1.25|Ratio of Arithmetic Means|0.95|||||TWO_SIDED|95.0|0.88|1.01|||||Ratio (MK-1293 / EU-Approved Lantus)|||1.01|0.88|
72526218|NCT02059174|144583300|NON_INFERIORITY_OR_EQUIVALENCE|Similarity criteria calculated via Fieller's Theorem was 95% confidence interval for arithmetic mean ratio (MK-1293/EU-Lantus™) falls between 0.80-1.25|Ratio of Arithmetic Means|0.9|||||TWO_SIDED|95.0|0.81|0.99|||||Ratio (MK-1293 / EU-Approved Lantus)|||0.99|0.81|
72526219|NCT02059174|144583301|NON_INFERIORITY_OR_EQUIVALENCE|Similarity criteria calculated via Fieller's Theorem was 95% confidence interval for arithmetic mean ratio (MK-1293/EU-Lantus™) falls between 0.80-1.25|Ratio of Arithmetic Means|0.99|||||TWO_SIDED|95.0|0.92|1.06|||||Ratio (MK-1293 / EU-Approved Lantus)|||1.06|0.92|
72526220|NCT02059174|144583302|NON_INFERIORITY_OR_EQUIVALENCE|Similarity criteria calculated via Fieller's Theorem was 95% confidence interval for arithmetic mean ratio (MK-1293/EU-Lantus™) falls between 0.80-1.25|Ratio of Arithmetic Means|0.96|||||TWO_SIDED|95.0|0.91|1.02|||||Ratio (MK-1293 / EU-Approved Lantus)|||1.02|0.91|
72526221|NCT02059174|144583303|NON_INFERIORITY_OR_EQUIVALENCE|Similarity criteria was 90% confidence interval for geometric mean ratio (MK-1293/EU-Lantus™) falls between 0.80-1.25|Geometric Mean Ratio|0.97|||||TWO_SIDED|90.0|0.91|1.02|||||Ratio (MK-1293 / EU-Approved Lantus)|||1.02|0.91|
72526222|NCT02059174|144583304|NON_INFERIORITY_OR_EQUIVALENCE|Similarity criteria was 90% confidence interval for geometric mean ratio (MK-1293/EU-Lantus™) falls between 0.80-1.25|Geometric Mean Ratio|0.97|||||TWO_SIDED|90.0|0.93|1.03|||||Ratio (MK-1293 / EU-Approved Lantus)|||1.03|0.93|
72571284|NCT00446199|144671211|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon/van Elteren|Stratification by center||Comparison between DRSP/E2 (0.25mg/0.5mg) and Placebo with respect to a shift in the distribution of the end point. Null hypothesis: The distribution of the change from baseline to week 12 in vaginal maturation value is identical in both arms, alternative: there is a shift in the distribution.||||<0.0001
72571285|NCT00446199|144671211|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon/van Elteren|Stratification by center||Comparison between E2 (0.3mg) and Placebo with respect to a shift in the distribution of the end point. Null hypothesis: The distribution of the change from baseline to week 12 in vaginal maturation value is identical in both arms, alternative: there is a shift in the distribution.||||<0.0001
72526223|NCT02059174|144583305|NON_INFERIORITY_OR_EQUIVALENCE|Similarity criteria was 90% confidence interval for geometric mean ratio (MK-1293/EU-Lantus™) falls between 0.80-1.25|Geometric Mean Ratio|0.92|||||TWO_SIDED|90.0|0.86|0.97|||||Ratio (MK-1293 / EU-Approved Lantus)|||0.97|0.86|
72526224|NCT02059174|144583306|NON_INFERIORITY_OR_EQUIVALENCE|Similarity criteria was 90% confidence interval for geometric mean ratio (MK-1293/EU-Lantus™) falls between 0.80-1.25|Geometric Mean Ratio|1.0|||||TWO_SIDED|90.0|0.95|1.04|||||Ratio (MK-1293 / EU-Approved Lantus)|||1.04|0.95|
72526225|NCT00087594|144583317|SUPERIORITY_OR_OTHER||Difference|7.0|||||TWO_SIDED|95.0|-27.8|41.3||||||95% CI for G1 participants||41.3|-27.8|
72526226|NCT00087594|144583317|SUPERIORITY_OR_OTHER||Difference|13.0|||||TWO_SIDED|95.0|-10.4|35.4||||||95% CI for G2/3 participants||35.4|-10.4|
72526227|NCT00087594|144583317|SUPERIORITY_OR_OTHER||Difference|44.0|||||TWO_SIDED|95.0|12.0|76.9||||||95% CI for G1 participants with 2 log drop at W 12||76.9|12.0|
72526228|NCT00087594|144583317|SUPERIORITY_OR_OTHER||Difference|0.0|||||TWO_SIDED|||||||||95% CI for G1 participants with non 2 log drop at W 12||||
72526229|NCT00087594|144583317|SUPERIORITY_OR_OTHER||Difference|-13.0|||||TWO_SIDED|95.0|-77.2|50.5||||||95% CI for G1 participants with missing HCV-RNA at W 12||50.5|-77.2|
72526230|NCT01952041|144583331|SUPERIORITY|||||||0.8|||||||Chi-squared|Chi-square test statistic=0.06, degrees of freedom=2||||||0.80
72526231|NCT01952041|144583332|SUPERIORITY||Hazard Ratio (HR)|0.78||||0.43|TWO_SIDED|95.0|0.42|1.44|||Regression, Cox||Hazard ratio is intervention arm vs. TAU for time to first relapse from randomization. There is not a standard error (SE) that directly links to the hazard ratio. The confidence interval provided illustrates the dispersion for the hazard ratio.|||1.44|0.42|0.43
72526232|NCT01952041|144583333|SUPERIORITY||Slope|0.22|STANDARD_ERROR_OF_MEAN|0.41||0.58|TWO_SIDED|95.0|-0.58|1.02|||Mixed Models Analysis||Treatment by time interaction terms are given to test difference of slopes between arms.|||1.02|-0.58|0.58
72526233|NCT01952041|144583334|SUPERIORITY||Slope|0.02|STANDARD_ERROR_OF_MEAN|0.12||0.84|TWO_SIDED|95.0|-0.22|0.26|||Mixed Models Analysis||Treatment by time interaction terms are given to test difference of slopes between arms.|||0.26|-0.22|0.84
72526234|NCT01952041|144583335|SUPERIORITY||Slope|-2.7|STANDARD_ERROR_OF_MEAN|1.4||0.06|TWO_SIDED|95.0|-5.4|0.04|||Mixed Models Analysis||Treatment by time interaction terms are given to test difference of slopes between arms.|||0.04|-5.40|0.06
72526235|NCT03650387|144583343|OTHER||||||<|0.0001||||||Bonferroni-Holm was used for alpha correction.|Exact one-sample binomial test|The one-sample binomial test was used to test whether the probability of being a responder (p) is significantly above 60%.||||||< 0.0001
72526236|NCT03650387|144583344|OTHER||||||<|0.0001||||||Bonferroni-Holm was used for alpha correction.|Exact one-sample binomial test|The one-sample binomial test was used to test whether the probability of being a responder (p) is significantly above 60%.||||||< 0.0001
72526237|NCT03650387|144583345|OTHER||||||<|0.0001||||||Bonferroni-Holm was used for alpha correction.|Exact one-sample binomial test|The one-sample binomial test was used to test whether the probability of being a responder (p) is significantly above 60%.||||||< 0.0001
72526238|NCT01569568|144583352|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|TWO_SIDED|||||This is an uncorrected p-value. A priori threshold is 0.05.|t-test, 2 sided|||The null hypothesis predicts that the concentration of glutamine is the same for controls and OTCD patients in PCGM.||||0.001
72526239|NCT01569568|144583352|SUPERIORITY_OR_OTHER_LEGACY|||||||0.011|TWO_SIDED|||||This is an uncorrected p-value. A priori significance threshold is 0.05.|t-test, 2 sided|||The null hypothesis predicts that the concentration of myoinositol is the same for controls and OTCD patients in PCGM.||||0.011
72526240|NCT01569568|144583352|SUPERIORITY_OR_OTHER_LEGACY|||||||0.004|TWO_SIDED|||||This is an uncorrected p-value. A priori threshold was 0.05.|t-test, 2 sided|||The null hypothesis predicts that the concentration of glutamine is the same for controls and OTCD patients in PWM.||||0.004
72526241|NCT01569568|144583352|SUPERIORITY_OR_OTHER_LEGACY|||||||0.046|TWO_SIDED|||||This is an uncorrected p-value. A priori threshold was 0.05.|t-test, 2 sided|||The null hypothesis predicts that the concentration of myoinositol is the same for controls and OTCD patients in PWM.||||0.046
72526242|NCT01569568|144583353|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||Our a priori threshold for statistical significance was 0.05.|ANOVA|We ran a 2 (Group) x 6 (ROI Pair) ANOVA to assess functional connectivity between the nodes of the DMN, using age as a covariate.||The null hypothesis states predicts no main effects of Group, ROI pair, or Age, suggesting that the connectivity between all DMN nodes is the same across groups.||||<0.001
72526243|NCT01569568|144583353|SUPERIORITY_OR_OTHER_LEGACY|||||||0.024|TWO_SIDED|||||This is an uncorrected p-value. A priori significance threshold was 0.05.|ANOVA|We ran a series of post-hoc one-way ANOVAs to localize the main effect found. Age was used as a covariate.||The null hypothesis predicts that functional connectivity between the ACC/mPFC node and the left IPL node does not differ between groups.||||0.024
72571286|NCT00446199|144671212|SUPERIORITY_OR_OTHER|||||||0.0314||95.0||||no correction for multiplicity|Cochran-Mantel-Haenszel|stratification by center||Comparison of active treatment arm with placebo on complete 2\*4 table||||0.0314
72526244|NCT01569568|144583353|SUPERIORITY_OR_OTHER_LEGACY|||||||0.04|TWO_SIDED|||||This is an uncorrected p-value. A priori significance threshold is 0.05.|ANOVA|We ran a series of post-hoc one-way ANOVAs to localize the main effect found. Age was used as a covariate.||The null hypothesis predicts that functional connectivity between the ACC/mPFC node and the PCC node does not differ between groups.||||0.040
72526245|NCT01569568|144583353|SUPERIORITY_OR_OTHER_LEGACY|||||||0.008|TWO_SIDED|||||This is an uncorrected p-value. A priori significance threshold was 0.05|ANOVA|We ran a series of post-hoc one-way ANOVAs to localize the main effect found. Age was used as a covariate.||The null hypothesis predicts that functional connectivity between the ACC/mPFC node and the right IPL node does not differ between groups.||||0.008
72526246|NCT01569568|144583353|SUPERIORITY_OR_OTHER_LEGACY|||||||0.47|TWO_SIDED|||||This is an uncorrected p-value. A priori significance threshold was 0.05|ANOVA|We ran a series of post-hoc one-way ANOVAs to localize the main effect found. Age was used as a covariate.||The null hypothesis predicts that functional connectivity between the left IPL node and the right IPL node does not differ between groups.||||0.470
72571287|NCT00446199|144671212|SUPERIORITY_OR_OTHER|||||||0.878||95.0|||||Cochran-Mantel-Haenszel|Stratification by center||Comparison of active treatment arm with placebo on complete 2\*4 table||||0.8780
72571288|NCT00446199|144671212|SUPERIORITY_OR_OTHER|||||||0.5908||95.0|||||Cochran-Mantel-Haenszel|Stratification by center||Comparison of active treatment arm with placebo on complete 2\*4 table||||0.5908
72406934|NCT03890367|144322701|SUPERIORITY|The two-sided 97.5% CI of the ratio of post-vaccination GMTs was calculated using normal approximation of log-transformed titers. The superiority was demonstrated if the lower limit of the two-sided 97.5% CI of the ratio of GMTs between compared groups was \>1.|GMT Ratio|16.3|||||TWO_SIDED|97.5|12.7|21.0||||||||21.0|12.7|
72406935|NCT03890367|144322702|SUPERIORITY|The two-sided 97.5% CI was calculated based on the Wilson score method without continuity correction. The superiority was demonstrated if the lower limit of the 97.5% CI of the percentage difference between compared groups was \>0%.|Difference in Percentage|10.43|||||TWO_SIDED|97.5|5.68|16.2||||||||16.20|5.68|
72406936|NCT03890367|144322703|NON_INFERIORITY|The two-sided 97.5% CI was calculated based on the Wilson score method without continuity correction. The non-inferiority was demonstrated if the lower limit of the 97.5% CI of the percentage difference between compared groups was \>-10%.|Difference in Percentage|0.0|||||TWO_SIDED|97.5|-2.3|2.28||||||||2.28|-2.30|
72406937|NCT03890367|144322704|NON_INFERIORITY|The two-sided 97.5% CI of the ratio of post-vaccination GMTs was calculated using normal approximation of log-transformed titers. The non-inferiority was demonstrated if the lower limit of the two-sided 97.5% CI of the ratio of GMTs between compared groups was \>1/1.5.|GMT Ratio|1.32|||||TWO_SIDED|97.5|1.06|1.64||||||||1.64|1.06|
72406938|NCT03890367|144322705|SUPERIORITY|The two-sided 97.5% CI of the ratio of post-vaccination GMTs was calculated using normal approximation of log-transformed titers. The superiority was demonstrated if the lower limit of the two-sided 97.5% CI of the ratio of GMTs between compared groups was \>1.|GMT Ratio|1.32|||||TWO_SIDED|97.5|1.06|1.64||||||||1.64|1.06|
72526247|NCT01569568|144583353|SUPERIORITY_OR_OTHER_LEGACY|||||||0.829|TWO_SIDED|||||This is an uncorrected p-value. A priori significance threshold was 0.05|ANOVA|We ran a series of post-hoc one-way ANOVAs to localize the main effect found. Age was used as a covariate.||The null hypothesis predicts that functional connectivity between the PCC node and the left IPL node does not differ between groups.||||0.829
72526248|NCT01569568|144583353|SUPERIORITY_OR_OTHER_LEGACY|||||||0.801|TWO_SIDED|||||This is an uncorrected p-value. A priori significance threshold was 0.05|ANOVA|We ran a series of post-hoc one-way ANOVAs to localize the main effect found. Age was used as a covariate.||The null hypothesis predicts that functional connectivity between the PCC node and the right IPL node does not differ between groups.||||0.801
72406939|NCT03890367|144322706|NON_INFERIORITY|The two-sided 97.5% CI was calculated based on the Wilson score method without continuity correction. The non-inferiority was demonstrated if the lower limit of the 97.5% CI of the percentage difference between compared groups was \>-10%.|Difference in Percentage|5.24|||||TWO_SIDED|97.5|1.83|9.85||||||||9.85|1.83|
72406940|NCT03890367|144322707|NON_INFERIORITY|The two-sided 97.5% CI of the ratio of post-vaccination GMTs was calculated using normal approximation of log-transformed titers. The non-inferiority was demonstrated if the lower limit of the two-sided 97.5% CI of the ratio of GMTs between compared groups was \>1/1.5.|GMT Ratio|6.8|||||TWO_SIDED|97.5|5.04|9.18||||||||9.18|5.04|
72406941|NCT03890367|144322708|SUPERIORITY|The two-sided 97.5% CI of the ratio of post-vaccination GMTs was calculated using normal approximation of log-transformed titers. The superiority was demonstrated if the lower limit of the two-sided 97.5% CI of the ratio of GMTs between compared groups was \>1.|GMT Ratio|6.8|||||TWO_SIDED|97.5|5.04|9.18||||||||9.18|5.04|
72406942|NCT03890367|144322709|NON_INFERIORITY|The two-sided 97.5% CI was calculated based on the Wilson score method without continuity correction. The non-inferiority was demonstrated if the lower limit of the 97.5% CI of the percentage difference between compared groups was \>-10%.|Difference in Percentage|0.0|||||TWO_SIDED|97.5|-2.71|2.67||||||||2.67|-2.71|
72406943|NCT03890367|144322710|NON_INFERIORITY|The two-sided 97.5% CI of the ratio of post-vaccination GMTs was calculated using normal approximation of log-transformed titers. The non-inferiority was demonstrated if the lower limit of the two-sided 97.5% CI of the ratio of GMTs between compared groups was \>1/1.5.|GMT Ratio|2.27|||||TWO_SIDED|97.5|1.82|2.84||||||||2.84|1.82|
72526249|NCT01569568|144583353|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||Our a priori threshold for statistical significance was 0.05.|ANOVA|We ran a 2 (Group) x 6 (ROI Pair) ANOVA to assess functional connectivity between the nodes of the SMN, using age as a covariate.||The null hypothesis states predicts no main effects of Group, ROI pair, or Age, suggesting that the connectivity between all SMN nodes is the same across groups.||||<0.001
72526250|NCT01569568|144583353|SUPERIORITY_OR_OTHER_LEGACY|||||||0.55|TWO_SIDED|||||This is an uncorrected p-value. A priori significance threshold was 0.05.|ANOVA|We ran a series of post-hoc one-way ANOVAs to localize the main effect found. Age was used as a covariate.||The null hypothesis predicts that functional connectivity between the ACC node and the left aI/fO node does not differ between groups.||||0.550
72406944|NCT03890367|144322711|SUPERIORITY|The two-sided 97.5% CI of the ratio of post-vaccination GMTs was calculated using normal approximation of log-transformed titers. The superiority was demonstrated if the lower limit of the two-sided 97.5% CI of the ratio of GMTs between compared groups was \>1.|GMT Ratio|2.27|||||TWO_SIDED|97.5|1.82|2.84||||||||2.84|1.82|
72406945|NCT03370341|144322712|SUPERIORITY|||||||0.56|||||||t-test, 2 sided|||The null hypothesis was that of no difference in levels of IA between Active and Sham stimulation. A paired samples t-test was performed with a significance level of 0.05 (two-tailed).||||.56
72406946|NCT03370341|144322713|SUPERIORITY|||||||0.38|||||||t-test, 2 sided|||The null hypothesis was that of no difference in levels of IA between Active and Sham stimulation. A paired samples t-test was performed with a significance level of 0.05 (two-tailed).||||.38
72406947|NCT02449356|144322714|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.73|||<|0.05|TWO_SIDED|95.0|||||Chi-squared|||||||<0.05
72406948|NCT02449356|144322715|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Chi-squared|||||||>0.05
72526251|NCT01569568|144583353|SUPERIORITY_OR_OTHER_LEGACY|||||||0.113|TWO_SIDED|||||This is an uncorrected p-value. A priori significance threshold was 0.05.|ANOVA|We ran a series of post-hoc one-way ANOVAs to localize the main effect found. Age was used as a covariate.||The null hypothesis predicts that functional connectivity between the ACC node and the left SFG node does not differ between groups.||||0.113
72571289|NCT00446199|144671213|SUPERIORITY_OR_OTHER|||||||0.0027||95.0||||no correction for multiplicity|Cochran-Mantel-Haenszel|Stratification by center||Comparison of active treatment arm with placebo on complete 2\*4 table||||0.0027
72571290|NCT00446199|144671213|SUPERIORITY_OR_OTHER|||||||0.4463||95.0|||||Cochran-Mantel-Haenszel|Stratification by center||Comparison of active treatment arm with placebo on complete 2\*4 table||||0.4463
72526252|NCT01569568|144583353|SUPERIORITY_OR_OTHER_LEGACY|||||||0.039|TWO_SIDED|||||This is an uncorrected p-value. A priori significance threshold was 0.05.|ANOVA|We ran a series of post-hoc one-way ANOVAs to localize the main effect found. Age was used as a covariate.||The null hypothesis predicts that functional connectivity between the ACC node and the right aI/fO node does not differ between groups.||||0.039
72526253|NCT01569568|144583353|SUPERIORITY_OR_OTHER_LEGACY|||||||0.005|TWO_SIDED|||||This is an uncorrected p-value. A priori significance threshold was 0.05.|ANOVA|We ran a series of post-hoc one-way ANOVAs to localize the main effect found. Age was used as a covariate.||The null hypothesis predicts that functional connectivity between the ACC node and the right SFG node does not differ between groups.||||0.005
72526254|NCT01569568|144583353|SUPERIORITY_OR_OTHER_LEGACY|||||||0.426|TWO_SIDED|||||This is an uncorrected p-value. A priori significance threshold was 0.05.|ANOVA|We ran a series of post-hoc one-way ANOVAs to localize the main effect found. Age was used as a covariate.||The null hypothesis predicts that functional connectivity between the left aI/fO and the left SFG node does not differ between groups.||||0.426
72526255|NCT01569568|144583353|SUPERIORITY_OR_OTHER_LEGACY|||||||0.256|TWO_SIDED|||||This is an uncorrected p-value. A priori significance threshold was 0.05.|ANOVA|We ran a series of post-hoc one-way ANOVAs to localize the main effect found. Age was used as a covariate.||The null hypothesis predicts that functional connectivity between the left aI/fO node and the right aI/fO node does not differ between groups.||||0.256
72406949|NCT00533949|144322728|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.38||||0.0042|TWO_SIDED|95.0|1.09|1.76|||Log Rank||Reference group = 60 gy|The trial was a two-by-two factorial design with radiation therapy dose as one treatment factor and cetuximab as the other. A log-rank test for each factor at one-sided α of 0.0125 (α of 0.0250 for both factors to account for multiple comparisons) would yield power of 80% to detect an improvement in median survival from 17.1 to 24 months after 339 deaths were reported out of 500 patients. For RT analysis, the comparison was arms 1 \& 3 vs arms 2 \& 4; for cetuximab, arms 1 \& 2 vs arms 3 \& 4.||1.76|1.09|0.0042
72406950|NCT00533949|144322728|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.07||||0.29|TWO_SIDED|95.0|0.84|1.35|||Log Rank||Reference level = cetuximab|The trial was a two-by-two factorial design with radiation therapy dose as one treatment factor and cetuximab as the other. A log-rank test for each factor at one-sided α of 0.0125 (α of 0.0250 for both factors to account for multiple comparisons) would yield power of 80% to detect an improvement in median survival from 17.1 to 24 months after 339 deaths were reported out of 500 patients. For RT analysis, the comparison was arms 1 \& 3 vs arms 2 \& 4; for cetuximab, arms 1 \& 2 vs arms 3 \& 4.||1.35|0.84|0.29
72526256|NCT01569568|144583353|SUPERIORITY_OR_OTHER_LEGACY|||||||0.853|TWO_SIDED|||||This is an uncorrected p-value. A priori significance threshold was 0.05.|ANOVA|We ran a series of post-hoc one-way ANOVAs to localize the main effect found. Age was used as a covariate.||The null hypothesis predicts that functional connectivity between the left aI/fO and the right SFG node does not differ between groups.||||0.853
72526257|NCT01569568|144583353|SUPERIORITY_OR_OTHER_LEGACY|||||||0.003|TWO_SIDED|||||This is an uncorrected p-value. A priori significance threshold was 0.05.|ANOVA|We ran a series of post-hoc one-way ANOVAs to localize the main effect found. Age was used as a covariate.||The null hypothesis predicts that functional connectivity between the right aI/fO node and the left SFG node does not differ between groups.||||0.003
72526258|NCT01569568|144583353|SUPERIORITY_OR_OTHER_LEGACY|||||||0.023|TWO_SIDED|||||This is an uncorrected p-value. A priori significance threshold was 0.05.|ANOVA|We ran a series of post-hoc one-way ANOVAs to localize the main effect found. Age was used as a covariate.||The null hypothesis predicts that functional connectivity between the right aI/fO node and the right SFG node does not differ between groups.||||0.023
72526259|NCT01569568|144583355|SUPERIORITY_OR_OTHER_LEGACY|||||||0.929|TWO_SIDED|||||Equal variance is not assumed. Two tailed t-test WASI verbal IQ between cases and controls|t-test, 2 sided|||||||.929
72526260|NCT01569568|144583355|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002|TWO_SIDED|||||Equal variance not assumed. Comparison WASI performance IQ cases and controls|t-test, 2 sided|||||||.002
72406951|NCT00533949|144322729|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.19||||0.12|TWO_SIDED|95.0|0.95|1.47|||Log Rank||Reference level = 60 Gy|Progression-free survival is estimated by the Kaplan-Meier method. Comparisons by RT level and by cetuximab assignment are performed separately and tested with a two-sided significance level of 0.05 for each comparison.||1.47|0.95|0.12
72406952|NCT00533949|144322729|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.99||||0.89|TWO_SIDED|95.0|0.8|1.22|||Log Rank||Reference level = cetuximab|Progression-free survival is estimated by the Kaplan-Meier method. Comparisons by RT level and by cetuximab assignment are performed separately and tested with a two-sided significance level of 0.05.||1.22|0.80|0.89
72406953|NCT00533949|144322730|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.17||||0.24|TWO_SIDED|95.0|0.89|1.53|||Gray's test||Reference level = 60 Gy|Local-regional failure was estimated by the cumulative incidence method. Comparisons by RT level and by cetuximab assignment are performed separately and tested with a two-sided significance level of 0.05 for each comparison.||1.53|0.89|0.24
72526261|NCT01569568|144583355|SUPERIORITY_OR_OTHER_LEGACY|||||||0.094|TWO_SIDED|||||Equal variance not assumed. Comparison of WASI full IQ cases and controls|t-test, 2 sided|||||||.094
72526262|NCT01569568|144583355|SUPERIORITY_OR_OTHER_LEGACY|||||||0.853|TWO_SIDED|||||Equal variance not assumed. Comparison of CTMT global composite score between cases and controls|t-test, 2 sided|||||||.853
72526263|NCT01569568|144583355|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|TWO_SIDED|||||Equal variance not assumed. Comparison of BRIEF BRI cases and controls|t-test, 2 sided|||||||.001
72526264|NCT01569568|144583355|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||Equal variances not assumed. Comparison of BRIEF MI cases and controls|t-test, 2 sided|||||||<.001
72526265|NCT01569568|144583355|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||Equal variances not assumed. Comparison of BRIEF GEC between cases and controls.|t-test, 2 sided|||||||<0.001
72526266|NCT02145429|144583384|OTHER||Hazard Ratio (HR)|0.32||||0.04|TWO_SIDED|95.0|0.1|0.98|||Log Rank|||||0.98|0.10|0.04
72526267|NCT02145429|144583385|OTHER||Mean Difference (Final Values)|-1.18|||<|0.001|TWO_SIDED|95.0|-2.03|-0.31|||Mixed Models Analysis|||||-0.31|-2.03|<0.001
72526268|NCT02145429|144583386|OTHER||Mean Difference (Final Values)|-0.14||||0.26|TWO_SIDED|95.0|-1.89|1.62|||Mixed Models Analysis|||||1.62|-1.89|0.26
72526269|NCT00723489|144583404|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02||||0.86|TWO_SIDED|95.0|-0.3|0.2||P-value is not adjusted for multiple comparisons.|ANOVA||Mean (AD) - Mean (Non-AD)|||0.2|-0.3|0.86
72526270|NCT00723489|144583405|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.02||||0.86|TWO_SIDED|95.0|-0.2|0.2||P-value is not adjusted for multiple comparisons.|ANOVA||Mean (AD) - Mean (Non-AD)|||0.2|-0.2|0.86
72526271|NCT00723489|144583406|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2||||0.1|TWO_SIDED|95.0|-0.5|0.05||P-value is not adjusted for multiple comparisons.|ANOVA||Mean (AD) - Mean (Non-AD)|||0.05|-0.5|0.10
72526272|NCT00723489|144583407|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||0.66|TWO_SIDED|95.0|-0.2|0.3||P-value is not adjusted for multiple comparisons.|ANOVA||Mean (AD) - Mean (Non-AD)|||0.3|-0.2|0.66
72526273|NCT00723489|144583408|SUPERIORITY_OR_OTHER|||||||0.24||||||P-value is not adjusted for multiple comparisons.|Fisher Exact|||||||0.24
72406954|NCT00533949|144322730|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.84||||0.22|TWO_SIDED|95.0|0.64|1.1|||Gray's test||Reference level = cetuximab|Local-regional failure was estimated by the cumulative incidence method. Comparisons by RT level and by cetuximab assignment are performed separately and tested with a two-sided significance level of 0.05 for each comparison.||1.10|0.64|0.22
72406955|NCT00533949|144322731|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||Chi-squared|||Esophagitis: Only those toxicities reported as possibly, probably, or definitely related to treatment were considered. The worst grade of esophagitis and the worst grade of pneumonitis at any time were classified by binary groupings of \< grade 3 and \>= grade 3. Comparisons were made using a two-sided chi-square test with a significance level of 0.05.||||<0.0001
72406956|NCT00533949|144322731|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2533|||||||Chi-squared|||PNEUMONITIS: Only those toxicities reported as possibly, probably, or definitely related to treatment were considered. The worst grade of esophagitis and the worst grade of pneumonitis at any time were classified by binary groupings of \< grade 3 and \>= grade 3. Comparisons were made using a two-sided chi-square test with a significance level of 0.05.||||0.2533
72526274|NCT00723489|144583409|SUPERIORITY_OR_OTHER|||||||0.43||||||P-value is not adjusted for multiple comparisons.|Fisher Exact|||||||0.43
72526275|NCT00723489|144583410|SUPERIORITY_OR_OTHER||Mean Difference (Final Values) Day 30|0.1||||0.48|TWO_SIDED|95.0|-0.1|0.3||P-value is not adjusted for multiple comparisons.|Mixed Models Analysis||Mean (AD) - Mean (Non-AD)|This analysis excludes 1 SC-(AD) participant who did not seroconvert. Only participants who had peripheral blood T-cell samples collected from Day 0 to Day 30 as specified in the Outcome Measure Time Frame were included in analysis (1 SC -(Non-AD) participant was excluded). T-cell data from 3 SC-(Non-AD) and 1 SC-(AD) participant was excluded due to problems with sample processing||0.3|-0.1|0.48
72526276|NCT00723489|144583411|SUPERIORITY_OR_OTHER||Mean Difference (Final Values) Day 30|-0.3||||0.036|TWO_SIDED|95.0|-0.5|-0.02||P-value is not adjusted for multiple comparisons.|Mixed Models Analysis||Mean (AD) - Mean (Non-AD)|Participants who did not seroconvert were excluded from this analysis (2 TC-(AD) and 5 TC-(Non-AD)). T-cell data from 4 TC-(AD) and 3 TC-(Non-AD) subjects was excluded due to problems with sample processing||-0.02|-0.5|0.036
72526277|NCT00723489|144583412|SUPERIORITY_OR_OTHER||Mean Difference (Final Values) Day 30|0.04||||0.82|TWO_SIDED|95.0|-0.3|0.4||P-value is not adjusted for multiple comparisons.|Mixed Models Analysis||Mean (AD) - Mean (Non-AD)|This analysis excludes 1 SC-(AD) participant who did not seroconvert. Only participants who had peripheral blood T-cell samples collected from Day 0 to Day 30 as specified in the Outcome Measure Time Frame were included in analysis (1 SC -(Non-AD) participant was excluded). T-cell data from 3 SC-(Non-AD) and 1 SC-(AD) participant was excluded due to problems with sample processing||0.4|-0.3|0.82
72526278|NCT00723489|144583413|SUPERIORITY_OR_OTHER||Mean Difference (Final Values) Day 30|-0.4||||0.045|TWO_SIDED|95.0|-0.7|-0.01||P-value is not adjusted for multiple comparisons.|Mixed Models Analysis||Mean (AD) - Mean (Non-AD)|Participants who did not seroconvert were excluded from this analysis (2 TC-(AD) and 5 TC-(Non-AD)). T-cell data from 4 TC-(AD) and 3 TC-(Non-AD) subjects was excluded due to problems with sample processing||-0.01|-0.7|0.045
72571291|NCT00446199|144671213|SUPERIORITY_OR_OTHER|||||||0.0303||95.0|||||Cochran-Mantel-Haenszel|Stratification by center||Comparison of active treatment arm with placebo on complete 2\*4 table||||0.0303
72406957|NCT00533949|144322732|SUPERIORITY_OR_OTHER_LEGACY|||||||0.52|||||||Chi-squared|||Only those toxicities reported as possibly, probably, or definitely related to treatment were considered. The worst grade of of toxicity at any time was classified by a binary grouping of \< grade 3 and \>= grade 3. Comparisons were made using a two-sided chi-square test.||||0.52
72406958|NCT00533949|144322734|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0233|||||||Cochran-Mantel-Haenszel|||FACT-TOI-LCS was assessed and changes from baseline to 3 months calculated and grouped using a 2 point decline as the threshold. Comparisons of decline vs no decline by RT level were from a Cochran-Mantel-Haenszel test and controlling for cetuximab assignment using a two-side significance level of 0.05.||||0.0233
72526279|NCT01599585|144583414|NON_INFERIORITY_OR_EQUIVALENCE|One tailed test at .05a = .05 margin was set at standardized difference of .50|Regression, Beta|0.4|||||TWO_SIDED|90.0|0.12|0.68||||||||.68|.12|
72526280|NCT01599585|144583426|NON_INFERIORITY_OR_EQUIVALENCE|One tailed test at .05a = .05 margin was set at standardized difference of .50|Regression, Beta|0.47|||||TWO_SIDED|90.0|0.16|0.78||||||||.78|.16|
72526281|NCT00853112|144583440|SUPERIORITY_OR_OTHER||Predicted Mean Difference|-115.0|STANDARD_DEVIATION|98.36||0.12|TWO_SIDED|95.0|-371.5|-1.1|||Bayesian 4-parameter Emax model|||Change over 4 hours post-dose: The Bayesian 4-parameter Emax model was used for analysis. 95% credible intervals of the effect size and the posterior distribution were calculated. Posterior distribution was used to calculate a probability (presented as p value) that the dose gives a difference of \>=240 dyne\*s\*m\^2/cm\^5 from placebo. The predicted means and SD were the posterior means and standard deviation (SD) from the Bayesian analysis.||-1.1|-371.5|0.120
72571292|NCT00446199|144671214|SUPERIORITY_OR_OTHER|||||||0.4397||95.0||||no correction for multiplicity|Cochran-Mantel-Haenszel|Stratification by center||Comparison of active treatment arm with placebo on complete 2\*4 table||||0.4397
72571293|NCT00446199|144671214|SUPERIORITY_OR_OTHER|||||||0.0132||95.0|||||Cochran-Mantel-Haenszel|Stratification by center||Comparison of active treatment arm with placebo on complete 2\*4 table||||0.0132
72571294|NCT00446199|144671214|SUPERIORITY_OR_OTHER|||||||0.325||95.0|||||Cochran-Mantel-Haenszel|Stratification by center||Comparison of active treatment arm with placebo on complete 2\*4 table||||0.3250
72571295|NCT00446199|144671215|SUPERIORITY_OR_OTHER|||||||0.9555||95.0||||no correction for multiplicity|Cochran-Mantel-Haenszel|Stratification by center||Comparison of active treatment arm with placebo on complete 2\*4 table||||0.9555
72526282|NCT00853112|144583440|SUPERIORITY_OR_OTHER||Predicted Mean Difference|-170.6|STANDARD_DEVIATION|107.84||0.25|TWO_SIDED|95.0|-409.2|-7.1|||Bayesian 4-parameter Emax model.|||Change over 4 hours post-dose: The Bayesian 4-parameter Emax model was used for analysis. 95% credible intervals of the effect size and the posterior distribution were calculated. Posterior distribution was used to calculate a probability (presented as p value) that the dose gives a difference of \>=240 dyne.s.m2/cm5 from placebo. The predicted means and SD were the posterior means and SD from the Bayesian analysis.||-7.1|-409.2|0.250
72526283|NCT00853112|144583440|SUPERIORITY_OR_OTHER||Predicted Mean Difference|-240.2|STANDARD_DEVIATION|109.28||0.485|TWO_SIDED|95.0|-444.8|-33.8|||Bayesian 4-parameter Emax model.|||The Bayesian 4-parameter Emax model was used for analysis. 95% credible intervals of the effect size and the posterior distribution were calculated. Posterior distribution was used to calculate a probability (presented as p value) that the dose gives a difference of \>=240 dyne\*s\*m\^2/cm\^5 from placebo. The predicted means and SD were the posterior means and SD from the Bayesian analysis.||-33.8|-444.8|0.485
72526284|NCT00853112|144583440|SUPERIORITY_OR_OTHER||Predicted Mean Difference|-327.9|STANDARD_DEVIATION|92.41||0.81|TWO_SIDED|95.0|-492.9|-148.0|||Bayesian 4-parameter Emax model.|||Change over 4 hours post-dose: The Bayesian 4-parameter Emax model was used for analysis. 95% credible intervals of the effect size and the posterior distribution were calculated. Posterior distribution was used to calculate a probability (presented as p value) that the dose gives a difference of \>=240 dyne\*s\*m\^2/cm\^5 from placebo. The predicted means and SD were the posterior means and SD from the Bayesian analysis.||-148.0|-492.9|0.810
72526285|NCT00853112|144583440|SUPERIORITY_OR_OTHER||Predicted Mean Difference|-379.4|STANDARD_DEVIATION|73.61||0.974|TWO_SIDED|95.0|-520.6|-238.8|||Bayesian 4-parameter Emax model|||Change over 4 hours post-dose: The Bayesian 4-parameter Emax model was used for analysis. Posterior distribution was calculated and was used to calculate a probability (presented as p value) that the dose gives a difference of \>=240 dyne\*s\*m\^2/cm\^5 from placebo. The predicted means and SD were the posterior means and SD from the Bayesian analysis.||-238.8|-520.6|0.974
72406959|NCT00533949|144322735|SUPERIORITY|||||||0.92|||||||t-test, 2 sided|Two-sided significance level = 0.05||||||0.92
72571296|NCT00446199|144671215|SUPERIORITY_OR_OTHER|||||||0.1743||95.0|||||Cochran-Mantel-Haenszel|Stratification by center||Comparison of active treatment arm with placebo on complete 2\*4 table||||0.1743
72406960|NCT00533949|144322736|SUPERIORITY|||||||0.19|||||||t-test, 2 sided|Two-sided significance level = 0.05||||||0.19
72406961|NCT00533949|144322737|SUPERIORITY||Hazard Ratio (HR)|0.95||||0.78|TWO_SIDED|95.0|0.68|1.33|||Regression, Cox||Reference level = EGFR H-Score \< 200|Univariate model of overall survival by EGFR group||1.33|0.68|0.78
72406962|NCT00533949|144322737|SUPERIORITY||Hazard Ratio (HR)|1.11||||0.61|TWO_SIDED|95.0|0.74|1.65|||Regression, Cox||Reference level = EGFR H-Score \< 200|Univariate model of time to local-regional failure by EGFR group||1.65|0.74|0.61
72526286|NCT00853112|144583441|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-195.3|STANDARD_ERROR_OF_MEAN|207.38||0.354|TWO_SIDED|95.0|-618.8|228.3|||ANCOVA|||GR over 4 hours, PVRI: The analysis was performed using Analysis of Covariance (ANCOVA) with baseline fitted as a covariate.||228.3|-618.8|0.354
72526287|NCT00853112|144583441|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-34.1|STANDARD_ERROR_OF_MEAN|190.99||0.86|TWO_SIDED|95.0|-424.1|356.0|||ANCOVA|||GR over 4 hours, PVRI: The analysis was performed using ANCOVA with baseline fitted as a covariate.||356.0|-424.1|0.860
72526288|NCT00853112|144583441|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-435.7|STANDARD_ERROR_OF_MEAN|195.94||0.034|TWO_SIDED|95.0|-835.9|-35.6|||ANCOVA|||GR over 4 hours, PVRI: The analysis was performed using ANCOVA with baseline fitted as a covariate.||-35.6|-835.9|0.034
72406963|NCT00533949|144322738|SUPERIORITY|||||||0.02||||||Two-sided significance level = 0.05|Chi-squared|||||||0.02
72526289|NCT00853112|144583441|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-334.7|STANDARD_ERROR_OF_MEAN|201.74||0.107|TWO_SIDED|95.0|-746.7|77.3|||ANCOVA|||GR over 4 hours, PVRI: The analysis was performed using ANCOVA with baseline fitted as a covariate.||77.3|-746.7|0.107
72406964|NCT00533949|144322739|OTHER||Cox Proportional Hazard|1.001||||0.06|TWO_SIDED|95.0|1.0|1.002||Two-sided significance level = 0.05|Regression, Cox||Corresponding to a one unit increase in GTV|Univariate model with GTV as a continuous variable||1.002|1.000|0.06
72526290|NCT00853112|144583441|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-278.0|STANDARD_ERROR_OF_MEAN|200.89||0.177|TWO_SIDED|95.0|-688.3|132.2|||ANCOVA|||GR over 4 hours, PVRI: The analysis was performed using ANCOVA with baseline fitted as a covariate.||132.2|-688.3|0.177
72526291|NCT00853112|144583441|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|51.1|STANDARD_ERROR_OF_MEAN|315.91||0.873|TWO_SIDED|95.0|-594.1|696.3|||ANCOVA|||GR over 4 hours, SVRI: The analysis was performed using ANCOVA with baseline fitted as a covariate.||696.3|-594.1|0.873
72571297|NCT00446199|144671215|SUPERIORITY_OR_OTHER|||||||0.4395||95.0|||||Cochran-Mantel-Haenszel|Stratification by center||Comparison of active treatment arm with placebo on complete 2\*4 table||||0.4395
72571298|NCT00446199|144671216|SUPERIORITY_OR_OTHER|||||||0.8966||95.0||||no correction for multiplicity|Cochran-Mantel-Haenszel|Stratification by center||Comparison of active treatment arm with placebo on complete 2\*4 table||||0.8966
72571299|NCT00446199|144671216|SUPERIORITY_OR_OTHER|||||||0.7512||95.0|||||Cochran-Mantel-Haenszel|Stratification by center||Comparison of active treatment arm with placebo on complete 2\*4 table||||0.7512
72406965|NCT00533949|144322739|SUPERIORITY||Hazard Ratio (HR)|1.001||||0.78|TWO_SIDED|95.0|0.997|1.004||Two-sided significance level = 0.05|Regression, Cox||Corresponding to a one unit increase in GTV|Multivariate model with GTV as a continuous variable, adjusting for planned radiation therapy dose group (60 Gy or 74 Gy) and the interaction of GTV and planned dose.|P-Value for the interaction of GTV and planned dose = 0.77|1.004|0.997|0.78
72406966|NCT00533949|144322740|SUPERIORITY||Cox Proportional Hazard|1.0||||0.94|TWO_SIDED|95.0|0.98|1.02|||Regression, Cox||Corresponding to a one unit increase in SUV|Univariate model of overall survival time by PET SUV as a continuous variable||1.02|0.98|0.94
72406967|NCT00533949|144322740|SUPERIORITY||Cox Proportional Hazard|1.0||||0.72|TWO_SIDED|95.0|0.98|1.02|||Regression, Cox||Corresponding to a one unit increase in SUV|Univariate model of time to local-regional failure by PET SUV as a continuous variable||1.02|0.98|0.72
72406968|NCT00533949|144322740|SUPERIORITY||Cox Proportional Hazard|1.0||||0.79|TWO_SIDED|95.0|0.98|1.02|||Regression, Cox||Corresponding to a one unit increase in SUV|Univariate model of time to distant metastasis by PET SUV as a continuous variable||1.02|0.98|0.79
72406969|NCT00727194|144322742|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-4.25||||0.0144|TWO_SIDED|95.0|-7.45|-1.05||No multiple comparisons or multiplicity adjustments were conducted.|paired t-test|||||-1.05|-7.45|0.0144
72526292|NCT00853112|144583441|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|75.2|STANDARD_ERROR_OF_MEAN|303.08||0.806|TWO_SIDED|95.0|-543.8|694.1|||ANCOVA|||GR over 4 hours, SVRI: The analysis was performed using ANCOVA with baseline fitted as a covariate.||694.1|-543.8|0.806
72526293|NCT00853112|144583441|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-262.8|STANDARD_ERROR_OF_MEAN|301.1||0.39|TWO_SIDED|95.0|-877.8|352.1|||ANCOVA|||GR over 4 hours, SVRI: The analysis was performed using ANCOVA with baseline fitted as a covariate.||352.1|-877.8|0.390
72526294|NCT00853112|144583441|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-329.4|STANDARD_ERROR_OF_MEAN|302.97||0.286|TWO_SIDED|95.0|-948.1|289.4|||ANCOVA|||GR over 4 hours, SVRI: The analysis was performed using ANCOVA with baseline fitted as a covariate.||289.4|-948.1|0.286
72526295|NCT00853112|144583441|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-62.7|STANDARD_ERROR_OF_MEAN|314.15||0.843|TWO_SIDED|95.0|-704.3|578.9|||ANCOVA|||GR over 4 hours, SVRI: The analysis was performed using ANCOVA with baseline fitted as a covariate.||578.9|-704.3|0.843
72406970|NCT00727194|144322742|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-4.71||||0.117|TWO_SIDED|95.0|-10.8|1.37||No multiple comparisons or multiplicity adjustments were conducted.|t-test, 2 sided|||||1.37|-10.80|0.1170
72526296|NCT00853112|144583442|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|322.8||0.999|TWO_SIDED|95.0|-659.7|658.8|||ANCOVA|||The analysis was performed using ANCOVA with baseline fitted as a covariate.||658.8|-659.7|0.999
72526297|NCT00853112|144583442|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|72.2|STANDARD_ERROR_OF_MEAN|309.69||0.817|TWO_SIDED|95.0|-560.2|704.7|||ANCOVA|||The analysis was performed using ANCOVA with baseline fitted as a covariate.||704.7|-560.2|0.817
72526298|NCT00853112|144583442|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-82.6|STANDARD_ERROR_OF_MEAN|307.67||0.79|TWO_SIDED|95.0|-711.0|545.7|||ANCOVA|||The analysis was performed using ANCOVA with baseline fitted as a covariate.||545.7|-711.0|0.790
72526299|NCT00853112|144583442|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-325.6|STANDARD_ERROR_OF_MEAN|309.58||0.301|TWO_SIDED|95.0|-957.8|306.7|||ANCOVA|||The analysis was performed using ANCOVA with baseline fitted as a covariate.||306.7|-957.8|0.301
72571300|NCT00446199|144671216|SUPERIORITY_OR_OTHER|||||||0.8751||95.0|||||Cochran-Mantel-Haenszel|Stratification by center||Comparison of active treatment arm with placebo on complete 2\*4 table||||0.8751
72406971|NCT00727194|144322743|SUPERIORITY_OR_OTHER_LEGACY|||||||1|TWO_SIDED|||||No multiple comparisons or multiplicity adjustments were conducted.|Chi-squared|||||||1.0000
72406972|NCT00727194|144322743|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0606|TWO_SIDED|||||No multiple comparisons or multiplicity adjustments were conducted.|Chi-squared|||||||0.0606
72526300|NCT00853112|144583442|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-61.2|STANDARD_ERROR_OF_MEAN|321.0||0.85|TWO_SIDED|95.0|-716.8|594.4|||ANCOVA|||The analysis was performed using ANCOVA with baseline fitted as a covariate.||594.4|-716.8|0.850
72406973|NCT00727194|144322744|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-1.58||||0.1873|TWO_SIDED|95.0|-4.08|0.91||No multiple comparisons or multiplicity adjustments were conducted.|paired t-test|||||0.91|-4.08|0.1873
72571301|NCT00446199|144671217|SUPERIORITY_OR_OTHER|||||||0.1067||95.0|||||Cochran-Mantel-Haenszel|Stratification for center||Comparison of active treatment arm with placebo||||0.1067
72526301|NCT00853112|144583443|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-269.32|STANDARD_ERROR_OF_MEAN|252.93||0.295|TWO_SIDED|95.0|-785.39|246.76|||Longitudinal analysis|||Change at Hour 1: The analysis was performed using longitudinal analysis model with baseline as a covariate.||246.76|-785.39|0.295
72526302|NCT00853112|144583443|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-97.65|STANDARD_ERROR_OF_MEAN|234.55||0.68|TWO_SIDED|95.0|-577.02|381.72|||Longitudinal analysis|||Change at Hour 1: The analysis was performed using longitudinal analysis model with baseline as a covariate.||381.72|-577.02|0.680
72526303|NCT00853112|144583443|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-376.61|STANDARD_ERROR_OF_MEAN|241.06||0.129|TWO_SIDED|95.0|-869.53|116.31|||Longitudinal analysis|||Change at Hour 1: The analysis was performed using longitudinal analysis model with baseline as a covariate.||116.31|-869.53|0.129
72571302|NCT00446199|144671217|SUPERIORITY_OR_OTHER|||||||0.6011||95.0|||||Cochran-Mantel-Haenszel|Stratification for center||Comparison of active treatment arm with placebo||||0.6011
72571303|NCT00446199|144671217|SUPERIORITY_OR_OTHER|||||||0.4408||95.0|||||Cochran-Mantel-Haenszel|Stratification for center||Comparison of active treatment arm with placebo||||0.4408
72406974|NCT00727194|144322744|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-3.57||||0.041|TWO_SIDED|95.0|-6.97|-0.17||No multiple comparisons or multiplicity adjustments were conducted.|t-test, 2 sided|||||-0.17|-6.97|0.0410
72406975|NCT00727194|144322745|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.83||||0.919|TWO_SIDED|95.0|-16.94|18.6||No multiple comparisons or multiplicity adjustments were conducted.|paired t-test|||Physical Functioning||18.60|-16.94|0.9190
72406976|NCT00727194|144322745|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-7.86||||0.5931|TWO_SIDED|95.0|-39.05|23.33||No multiple comparisons or multiplicity adjustments were conducted.|t-test, 2 sided|||Physical Functioning||23.33|-39.05|0.5931
72406977|NCT00727194|144322745|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Net)|3.13||||0.7319|TWO_SIDED|95.0|-16.64|22.89||No multiple comparisons or multiplicity adjustments were conducted.|Paired t-test|||Role Physical||22.89|-16.64|0.7319
72526304|NCT00853112|144583443|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-342.29|STANDARD_ERROR_OF_MEAN|247.07||0.176|TWO_SIDED|95.0|-846.9|162.32|||Longitudinal analysis|||Change at Hour 1: The analysis was performed using longitudinal analysis model with baseline as a covariate.||162.32|-846.90|0.176
72526305|NCT00853112|144583443|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-316.86|STANDARD_ERROR_OF_MEAN|261.58||0.235|TWO_SIDED|95.0|-850.9|217.17|||Longitudinal analysis|||Hour 1: Longitudinal analysis was used to analyze p-value and included baseline as a covariate.||217.17|-850.90|0.235
72571304|NCT00446199|144671218|SUPERIORITY_OR_OTHER|||||||0.0144||95.0|||||Cochran-Mantel-Haenszel|Stratification for center||Comparison of active treatment arm with placebo||||0.0144
72571305|NCT00446199|144671218|SUPERIORITY_OR_OTHER|||||||0.5589||95.0|||||Cochran-Mantel-Haenszel|Stratification for center||Comparison of active treatment arm with placebo||||0.5589
72571306|NCT00446199|144671218|SUPERIORITY_OR_OTHER|||||||0.55||95.0|||||Cochran-Mantel-Haenszel|Stratification for center||Comparison of active treatment arm with placebo||||0.5500
72406978|NCT00727194|144322745|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Net)|-7.14||||0.691|TWO_SIDED|95.0|-45.36|31.08||No multiple comparisons or multiplicity adjustments were conducted.|t-test, 2 sided|||Role Physical||31.08|-45.36|0.6910
72406979|NCT00727194|144322745|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-9.42||||0.1311|TWO_SIDED|95.0|-22.18|3.34||No multiple comparisons or multiplicity adjustments were conducted.|Paired t-test|||Bodily Pain||3.34|-22.18|0.1311
72526306|NCT00853112|144583443|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-198.06|STANDARD_ERROR_OF_MEAN|247.62||0.43|TWO_SIDED|95.0|-705.04|308.91|||Longitudinal analysis|||Change at Hour 2: The analysis was performed using longitudinal analysis model with baseline as a covariate.||308.91|-705.04|0.430
72526307|NCT00853112|144583443|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|37.9|STANDARD_ERROR_OF_MEAN|229.23||0.87|TWO_SIDED|95.0|-432.23|508.04|||Longitudinal analysis|||Change at Hour 2: The analysis was performed using longitudinal analysis model with baseline as a covariate.||508.04|-432.23|0.870
72526308|NCT00853112|144583443|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-114.06|STANDARD_ERROR_OF_MEAN|244.95||0.645|TWO_SIDED|95.0|-614.57|386.45|||Longitudinal analysis|||Change at Hour 2: The analysis was performed using longitudinal analysis model with baseline as a covariate.||386.45|-614.57|0.645
72526309|NCT00853112|144583443|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-299.6|STANDARD_ERROR_OF_MEAN|241.63||0.225|TWO_SIDED|95.0|-794.81|195.61|||Longitudinal analysis|||Change at Hour 2: The analysis was performed using longitudinal analysis model with baseline as a covariate.||195.61|-794.81|0.225
72526310|NCT00853112|144583443|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-332.25|STANDARD_ERROR_OF_MEAN|255.93||0.205|TWO_SIDED|95.0|-856.55|192.05|||Longitudinal analysis|||Change at Hour 2: The analysis was performed using longitudinal analysis model with baseline as a covariate.||192.05|-856.55|0.205
72526311|NCT00853112|144583443|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-86.72|STANDARD_ERROR_OF_MEAN|263.63||0.745|TWO_SIDED|95.0|-625.87|452.42|||Longitudinal analysis|||Change at Hour 3: The analysis was performed using longitudinal analysis model with baseline as a covariate.||452.42|-625.87|0.745
72526312|NCT00853112|144583443|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|18.0|STANDARD_ERROR_OF_MEAN|245.25||0.942|TWO_SIDED|95.0|-484.46|520.47|||Longitudinal analysis|||Change at Hour 3: The analysis was performed using longitudinal analysis model with baseline as a covariate.||520.47|-484.46|0.942
72526313|NCT00853112|144583443|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-265.94|STANDARD_ERROR_OF_MEAN|259.53||0.314|TWO_SIDED|95.0|-796.15|264.28|||Longitudinal analysis|||Change at Hour 3: The analysis was performed using longitudinal analysis model with baseline as a covariate.||264.28|-796.15|0.314
72526314|NCT00853112|144583443|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-275.35|STANDARD_ERROR_OF_MEAN|258.01||0.295|TWO_SIDED|95.0|-803.57|252.88|||Longitudinal analysis|||Change at Hour 3: The analysis was performed using longitudinal analysis model with baseline as a covariate.||252.88|-803.57|0.295
72526315|NCT00853112|144583443|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-326.55|STANDARD_ERROR_OF_MEAN|272.96||0.241|TWO_SIDED|95.0|-885.12|232.02|||Longitudinal analysis|||Change at Hour 3: The analysis was performed using longitudinal analysis model with baseline as a covariate.||232.02|-885.12|0.241
72526316|NCT00853112|144583443|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-145.71|STANDARD_ERROR_OF_MEAN|218.5||0.51|TWO_SIDED|95.0|-592.24|300.83|||Longitudinal analysis|||Change at Hour 4: The analysis was performed using longitudinal analysis model with baseline as a covariate.||300.83|-592.24|0.510
72526317|NCT00853112|144583443|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|77.96|STANDARD_ERROR_OF_MEAN|199.85||0.699|TWO_SIDED|95.0|-330.7|486.63|||Longitudinal analysis|||Change at Hour 4: The analysis was performed using longitudinal analysis model with baseline as a covariate.||486.63|-330.70|0.699
72526318|NCT00853112|144583443|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-341.91|STANDARD_ERROR_OF_MEAN|204.65||0.106|TWO_SIDED|95.0|-760.45|76.64|||Longitudinal analysis|||Change at Hour 4: The analysis was performed using longitudinal analysis model with baseline as a covariate.||76.64|-760.45|0.106
72406980|NCT00727194|144322745|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-14.86||||0.2406|TWO_SIDED|95.0|-41.08|11.36||No multiple comparisons or multiplicity adjustments were conducted.|t-test, 2 sided|||Bodily Pain||11.36|-41.08|0.2406
72406981|NCT00727194|144322745|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|7.17||||0.0578|TWO_SIDED|95.0|-0.29|14.62||No multiple comparisons or multiplicity adjustments were conducted.|Paired t-test|||General Health||14.62|-0.29|0.0578
72526319|NCT00853112|144583443|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-289.41|STANDARD_ERROR_OF_MEAN|211.69||0.182|TWO_SIDED|95.0|-722.17|143.35|||Longitudinal analysis|||Change at Hour 4: The analysis was performed using longitudinal analysis model with baseline as a covariate.||143.35|-722.17|0.182
72526320|NCT00853112|144583443|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-256.6|STANDARD_ERROR_OF_MEAN|224.88||0.263|TWO_SIDED|95.0|-716.26|203.06|||Longitudinal analysis|||Change at Hour 4: The analysis was performed using longitudinal analysis model with baseline as a covariate.||203.06|-716.26|0.263
72526321|NCT00853112|144583444|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-328.1|STANDARD_ERROR_OF_MEAN|385.78||0.401|TWO_SIDED|95.0|-1114.11|457.92|||Longitudinal analysis|||Change at Hour 1: The analysis was performed using longitudinal analysis model with baseline as a covariate.||457.92|-1114.11|0.401
72526322|NCT00853112|144583444|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-164.96|STANDARD_ERROR_OF_MEAN|370.54||0.659|TWO_SIDED|95.0|-920.05|590.12|||Longitudinal analysis|||Change at Hour 1: The analysis was performed using longitudinal analysis model with baseline as a covariate.||590.12|-920.05|0.659
72526323|NCT00853112|144583444|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-287.08|STANDARD_ERROR_OF_MEAN|372.6||0.447|TWO_SIDED|95.0|-1047.59|473.42|||Longitudinal analysis|||Change at Hour 1: The analysis was performed using longitudinal analysis model with baseline as a covariate.||473.42|-1047.59|0.447
72406982|NCT00727194|144322745|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|7.43||||0.5073|TWO_SIDED|95.0|-16.26|31.11||No multiple comparisons or multiplicity adjustments were conducted.|t-test, 2 sided|||General Health||31.11|-16.26|0.5073
72406983|NCT00727194|144322745|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|4.17||||0.2474|TWO_SIDED|95.0|-3.39|11.72||No multiple comparisons or multiplicity adjustments were conducted.|Paired t-test|||Vitality||11.72|-3.39|0.2474
72526324|NCT00853112|144583444|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-457.16|STANDARD_ERROR_OF_MEAN|374.26||0.231|TWO_SIDED|95.0|-1220.86|306.53|||Longitudinal analysis|||Change at Hour 1: The analysis was performed using longitudinal analysis model with baseline as a covariate.||306.53|-1220.86|0.231
72571307|NCT00446199|144671219|SUPERIORITY_OR_OTHER|||||||0.2179||95.0|||||Cochran-Mantel-Haenszel|Stratification for center||Comparison of active treatment arm with placebo||||0.2179
72571308|NCT00446199|144671219|SUPERIORITY_OR_OTHER|||||||0.7749||95.0|||||Cochran-Mantel-Haenszel|Stratification for center||Comparison of active treatment arm with placebo||||0.7749
72571309|NCT00446199|144671219|SUPERIORITY_OR_OTHER|||||||0.8307||95.0|||||Cochran-Mantel-Haenszel|Stratification for center||Comparison of active treatment arm with placebo||||0.8307
72571310|NCT00446199|144671220|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-27.6|||<|0.0001||95.0|-33.2|-22.0||significance level of 1.7% is used to adjust (Bonferroni) for the comparison of three active arms with Placebo.|ANCOVA|treatment, center and baseline value used as covariate|Change in active treatment arm minus change in placebo arm|Comparison between DRSP/E2 (0.5mg/0.5mg) and Placebo with respect to a shift in the distribution of the end point. Null hypothesis: The mean change from baseline to week 12 is identical in both arms, alternative: there is a difference in the mean change from baseline.||-22.0|-33.2|<0.0001
72526325|NCT00853112|144583444|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-75.24|STANDARD_ERROR_OF_MEAN|384.2||0.846|TWO_SIDED|95.0|-858.19|707.71|||Longitudinal analysis|||Change at Hour 1: The analysis was performed using longitudinal analysis model with baseline as a covariate.||707.71|-858.19|0.846
72526326|NCT00853112|144583444|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-115.64|STANDARD_ERROR_OF_MEAN|357.2||0.748|TWO_SIDED|95.0|-844.24|612.96|||Longitudinal analysis|||Change at Hour 2: The analysis was performed using longitudinal analysis model with baseline as a covariate.||612.96|-844.24|0.748
72526327|NCT00853112|144583444|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-2.87|STANDARD_ERROR_OF_MEAN|342.91||0.993|TWO_SIDED|95.0|-702.41|696.67|||Longitudinal analysis|||Change at Hour 2: The analysis was performed using longitudinal analysis model with baseline as a covariate.||696.67|-702.41|0.993
72526328|NCT00853112|144583444|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|174.2|STANDARD_ERROR_OF_MEAN|342.93||0.615|TWO_SIDED|95.0|-526.41|874.81|||Longitudinal analysis|||Change at Hour 2: The analysis was performed using longitudinal analysis model with baseline as a covariate.||874.81|-526.41|0.615
72526329|NCT00853112|144583444|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-494.91|STANDARD_ERROR_OF_MEAN|344.72||0.161|TWO_SIDED|95.0|-1199.04|209.21|||Longitudinal analysis|||Change at Hour 2: The analysis was performed using longitudinal analysis model with baseline as a covariate.||209.21|-1199.04|0.161
72526330|NCT00853112|144583444|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-134.48|STANDARD_ERROR_OF_MEAN|355.5||0.708|TWO_SIDED|95.0|-859.74|590.77|||Longitudinal analysis|||Change at Hour 2: The analysis was performed using longitudinal analysis model with baseline as a covariate.||590.77|-859.74|0.708
72571311|NCT00446199|144671220|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-22.2|||<|0.0001||95.0|-27.8|-16.6||significance level of 1.7% is used to adjust (Bonferroni) for the comparison of three active arms with Placebo.|ANCOVA|treatment, center and baseline value used as covariate|Change in active treatment arm minus change in placebo arm|Comparison between DRSP/E2 (0.25mg/0.5mg) and Placebo with respect to a shift in the distribution of the end point. Null hypothesis: The mean change from baseline to week 12 is identical in both arms, alternative: there is a difference in the mean change from baseline.||-16.6|-27.8|<0.0001
72571312|NCT00446199|144671220|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.8||||0.0007||95.0|-15.4|-4.2||significance level of 1.7% is used to adjust (Bonferroni) for the comparison of three active arms with Placebo.|ANCOVA|treatment, center and baseline value used as covariate|Change in active treatment arm minus change in placebo arm|Comparison between E2 (0.3mg) and Placebo with respect to a shift in the distribution of the end point. Null hypothesis: The mean change from baseline to week 12 is identical in both arms, alternative: there is a difference in the mean change from baseline||-4.2|-15.4|0.0007
72571313|NCT00446199|144671221|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-23.9|||<|0.0001||95.0|-29.9|17.8||significance level of 1.7% is used to adjust (Bonferroni) for the comparison of three active arms with Placebo.|ANCOVA|treatment, center and baseline value used as covariate|Change in active treatment arm minus change in placebo arm|Comparison between DRSP/E2 (0.5mg/0.5mg) and Placebo with respect to a shift in the distribution of the end point. Null hypothesis: The mean change from baseline to week 4 is identical in both arms, alternative: there is a difference in the mean change from baseline.||17.8|-29.9|<0.0001
72406984|NCT00727194|144322745|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-2.68||||0.8085|TWO_SIDED|95.0|-26.24|20.88||No multiple comparisons or multiplicity adjustments were conducted.|t-test, 2 sided|||Vitality||20.88|-26.24|0.8085
72406985|NCT00727194|144322745|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-11.46||||0.0716|TWO_SIDED|95.0|-24.13|1.21||No multiple comparisons or multiplicity adjustments were conducted.|Paired t-test|||Social Functioning||1.21|-24.13|0.0716
72406986|NCT00727194|144322745|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-16.07||||0.1966|TWO_SIDED|95.0|-41.68|9.54||No multiple comparisons or multiplicity adjustments were conducted.|t-test, 2 sided|||Social Functioning||9.54|-41.68|0.1966
72526331|NCT00853112|144583444|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|47.61|STANDARD_ERROR_OF_MEAN|365.43||0.897|TWO_SIDED|95.0|-697.56|792.79|||Longitudinal analysis|||Change at Hour 3: The analysis was performed using longitudinal analysis model with baseline as a covariate.||792.79|-697.56|0.897
72526332|NCT00853112|144583444|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|98.42|STANDARD_ERROR_OF_MEAN|350.87||0.781|TWO_SIDED|95.0|-617.15|813.99|||Longitudinal analysis|||Change at Hour 3: The analysis was performed using longitudinal analysis model with baseline as a covariate.||813.99|-617.15|0.781
72526333|NCT00853112|144583444|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-28.31|STANDARD_ERROR_OF_MEAN|355.47||0.937|TWO_SIDED|95.0|-753.46|696.83|||Longitudinal analysis|||Change at Hour 3: The analysis was performed using longitudinal analysis model with baseline as a covariate.||696.83|-753.46|0.937
72406987|NCT00727194|144322745|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-11.81||||0.1701|TWO_SIDED|95.0|-29.6|5.99||No multiple comparisons or multiplicity adjustments were conducted.|paired t-test|||Role Emotional||5.99|-29.60|0.1701
72406988|NCT00727194|144322745|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|5.95||||0.7422|TWO_SIDED|95.0|-32.58|44.48||No multiple comparisons or multiplicity adjustments were conducted.|t-test, 2 sided|||Role Emotional||44.48|-32.58|0.7422
72526334|NCT00853112|144583444|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-369.57|STANDARD_ERROR_OF_MEAN|353.25||0.304|TWO_SIDED|95.0|-1090.86|351.72|||Longitudinal analysis|||Change at Hour 3: The analysis was performed using longitudinal analysis model with baseline as a covariate.||351.72|-1090.86|0.304
72526335|NCT00853112|144583444|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-185.64|STANDARD_ERROR_OF_MEAN|363.77||0.613|TWO_SIDED|95.0|-927.54|556.27|||Longitudinal analysis|||Change at Hour 3: The analysis was performed using longitudinal analysis model with baseline as a covariate.||556.27|-927.54|0.613
72406989|NCT00727194|144322745|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.42||||0.9007|TWO_SIDED|95.0|-6.83|7.67||No multiple comparisons or multiplicity adjustments were conducted.|Paired t-test|||Mental Health||7.67|-6.83|0.9007
72406990|NCT00727194|144322745|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|17.86||||0.1519|TWO_SIDED|95.0|-7.57|43.29||No multiple comparisons or multiplicity adjustments were conducted.|t-test, 2 sided|||Mental Health||43.29|-7.57|0.1519
72526336|NCT00853112|144583444|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|265.51|STANDARD_ERROR_OF_MEAN|324.88||0.42|TWO_SIDED|95.0|-397.45|928.48|||Longitudinal analysis|||Change at Hour 4: The analysis was performed using longitudinal analysis model with baseline as a covariate.||928.48|-397.45|0.420
72526337|NCT00853112|144583444|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|240.17|STANDARD_ERROR_OF_MEAN|311.63||0.447|TWO_SIDED|95.0|-395.81|876.14|||Longitudinal analysis|||Change at Hour 4: The analysis was performed using longitudinal analysis model with baseline as a covariate.||876.14|-395.81|0.447
72526338|NCT00853112|144583444|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-176.74|STANDARD_ERROR_OF_MEAN|309.11||0.572|TWO_SIDED|95.0|-808.1|454.63|||Longitudinal analysis|||Change at Hour 4: The analysis was performed using longitudinal analysis model with baseline as a covariate.||454.63|-808.10|0.572
72526339|NCT00853112|144583444|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-27.96|STANDARD_ERROR_OF_MEAN|311.11||0.929|TWO_SIDED|95.0|-663.31|607.38|||Longitudinal analysis|||Change at Hour 4: The analysis was performed using longitudinal analysis model with baseline as a covariate.||607.38|-663.31|0.929
72526340|NCT00853112|144583444|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|29.58|STANDARD_ERROR_OF_MEAN|323.01||0.928|TWO_SIDED|95.0|-629.62|688.79|||Longitudinal analysis|||Change at Hour 4: The analysis was performed using longitudinal analysis model with baseline as a covariate.||688.79|-629.62|0.928
72526341|NCT00853112|144583445|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.24|STANDARD_ERROR_OF_MEAN|0.29||0.412|TWO_SIDED|95.0|-0.35|0.83|||Longitudinal analysis|||Change at Hour 1: The analysis was performed using longitudinal analysis model with baseline as a covariate.||0.83|-0.35|0.412
72526342|NCT00853112|144583445|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.28||0.999|TWO_SIDED|95.0|-0.58|0.58|||Longitudinal analysis|||Change at Hour 1: The analysis was performed using longitudinal analysis model with baseline as a covariate.||0.58|-0.58|0.999
72526343|NCT00853112|144583445|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.17|STANDARD_ERROR_OF_MEAN|0.28||0.535|TWO_SIDED|95.0|-0.39|0.74|||Longitudinal analysis|||Change at Hour 1: The analysis was performed using longitudinal analysis model with baseline as a covariate.||0.74|-0.39|0.535
72526344|NCT00853112|144583445|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.44|STANDARD_ERROR_OF_MEAN|0.28||0.128|TWO_SIDED|95.0|-0.13|1.01|||Longitudinal analysis|||Change at Hour 1: The analysis was performed using longitudinal analysis model with baseline as a covariate.||1.01|-0.13|0.128
72406991|NCT00727194|144322745|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|1.07||||0.6807|TWO_SIDED|95.0|-4.57|6.72||No multiple comparisons or multiplicity adjustments were conducted.|Paired t-test|||Physical Component Score||6.72|-4.57|0.6807
72406992|NCT00727194|144322745|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-6.23||||0.2226|TWO_SIDED|95.0|-16.79|4.32||No multiple comparisons or multiplicity adjustments were conducted.|t-test, 2 sided|||Physical Component Score||4.32|-16.79|0.2226
72576761|NCT00261443|144680647|SUPERIORITY_OR_OTHER_LEGACY||Difference|0.04||||0.557|TWO_SIDED|95.0|-0.09|0.18||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 4 Comparison||0.18|-0.09|0.557
72526345|NCT00853112|144583445|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.29||0.823|TWO_SIDED|95.0|-0.67|0.53|||Longitudinal analysis|||Change at Hour 1: The analysis was performed using longitudinal analysis model with baseline as a covariate.||0.53|-0.67|0.823
72526346|NCT00853112|144583445|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.29|STANDARD_ERROR_OF_MEAN|0.34||0.396|TWO_SIDED|95.0|-0.4|0.99|||Longitudinal analysis|||Change at Hour 2: The analysis was performed using longitudinal analysis model with baseline as a covariate.||0.99|-0.40|0.396
72526347|NCT00853112|144583445|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.04|STANDARD_ERROR_OF_MEAN|0.33||0.899|TWO_SIDED|95.0|-0.63|0.72|||Longitudinal analysis|||Change at Hour 2: The analysis was performed using longitudinal analysis model with baseline as a covariate.||0.72|-0.63|0.899
72526348|NCT00853112|144583445|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.33||0.928|TWO_SIDED|95.0|-0.7|0.64|||Longitudinal analysis|||Change at Hour 2: The analysis was performed using longitudinal analysis model with baseline as a covariate.||0.64|-0.70|0.928
72526349|NCT00853112|144583445|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.43|STANDARD_ERROR_OF_MEAN|0.33||0.203|TWO_SIDED|95.0|-0.25|1.11|||Longitudinal analysis|||Change at Hour 2: The analysis was performed using longitudinal analysis model with baseline as a covariate.||1.11|-0.25|0.203
72526350|NCT00853112|144583445|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.34||0.772|TWO_SIDED|95.0|-0.6|0.8|||Longitudinal analysis|||Change at Hour 2: The analysis was performed using longitudinal analysis model with baseline as a covariate.||0.80|-0.60|0.772
72526351|NCT00853112|144583445|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.09|STANDARD_ERROR_OF_MEAN|0.29||0.771|TWO_SIDED|95.0|-0.52|0.69|||Longitudinal analysis|||Change at Hour 3: The analysis was performed using longitudinal analysis model with baseline as a covariate.||0.69|-0.52|0.771
72406993|NCT00727194|144322745|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-2.92||||0.1505|TWO_SIDED|95.0|-7.1|1.26||No multiple comparisons or multiplicity adjustments were conducted.|Paired t-test|||Mental Component Score||1.26|-7.10|0.1505
72406994|NCT00727194|144322745|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|5.55||||0.4151|TWO_SIDED|95.0|-8.77|19.87||No multiple comparisons or multiplicity adjustments were conducted.|t-test, 2 sided|||Mental Component Score||19.87|-8.77|0.4151
72406995|NCT00727194|144322746|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|3.25||||0.3377|TWO_SIDED|95.0|-3.94|10.44||No multiple comparisons or multiplicity adjustments were conducted.|paired t-test|||Forced Vital Capacity||10.44|-3.94|0.3377
72406996|NCT00727194|144322746|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Net)|-10.57||||0.3391|TWO_SIDED|95.0|-33.71|12.56||No multiple comparisons or multiplicity adjustments were conducted.|t-test, 2 sided|||Forced Vital Capacity||12.56|-33.71|0.3391
72406997|NCT00727194|144322746|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.0||||1|TWO_SIDED|95.0|-4.35|4.35||No multiple comparisons or multiplicity adjustments were conducted.|paired t test|||Negative Inspiratory Force||4.35|-4.35|1.0000
72406998|NCT00727194|144322746|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-6.57||||0.2292|TWO_SIDED|95.0|-17.87|4.73||No multiple comparisons or multiplicity adjustments were conducted.|t-test, 2 sided|||Negative Inspiratory Force||4.73|-17.87|0.2292
72406999|NCT04269161|144322759|NON_INFERIORITY|The margin of non-inferiority is 10 seconds such that the device is no worse than 10 seconds on average than manual mode. Our study is a 2-treatment, 24-period crossover design that accounts for first-order carryover effects, indicating a slightly higher power than a 2x2. Each subject acted as their own control. The study was defined as intention to treat, such that manual adjustments during the automated arm would be included in that arm.|Mean Difference (Net)|-9.885||||0.003|TWO_SIDED|95.0|-16.51|-3.27||The p-value is significant at 0.01.|t-test, 2 sided||The difference is time to re-establish in automatic mode minus time to re-establish in manual mode. (a negative number favors automatic mode)|A sample requirement of 48 patients was determined based on a pilot study to provide 88% power, and 0.05 significance (two sided) to show the mean difference is less than 10 seconds based on a 2x2 crossover design. Considering patient drop-out, a sample size of n=40 drops power to 82%.||-3.27|-16.51|0.003
72526352|NCT00853112|144583445|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.29||0.572|TWO_SIDED|95.0|-0.75|0.42|||Longitudinal analysis|||Change at Hour 3: The analysis was performed using longitudinal analysis model with baseline as a covariate.||0.42|-0.75|0.572
72526353|NCT00853112|144583445|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.29||0.966|TWO_SIDED|95.0|-0.58|0.6|||Longitudinal analysis|||Change at Hour 3: The analysis was performed using longitudinal analysis model with baseline as a covariate.||0.60|-0.58|0.966
72526354|NCT00853112|144583445|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.41|STANDARD_ERROR_OF_MEAN|0.28||0.157|TWO_SIDED|95.0|-0.17|1.0|||Longitudinal analysis|||Change at Hour 3: The analysis was performed using longitudinal analysis model with baseline as a covariate.||1.00|-0.17|0.157
72526355|NCT00853112|144583445|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.18|STANDARD_ERROR_OF_MEAN|0.3||0.546|TWO_SIDED|95.0|-0.43|0.79|||Longitudinal analysis|||Change at Hour 3: The analysis was performed using longitudinal analysis model with baseline as a covariate.||0.79|-0.43|0.546
72526356|NCT00853112|144583445|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.07|STANDARD_ERROR_OF_MEAN|0.28||0.818|TWO_SIDED|95.0|-0.51|0.64|||Longitudinal analysis|||Change at Hour 4: The analysis was performed using longitudinal analysis model with baseline as a covariate.||0.64|-0.51|0.818
72526357|NCT00853112|144583445|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.28||0.603|TWO_SIDED|95.0|-0.71|0.42|||Longitudinal analysis|||Change at Hour 4: The analysis was performed using longitudinal analysis model with baseline as a covariate.||0.42|-0.71|0.603
72526358|NCT00853112|144583445|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.19|STANDARD_ERROR_OF_MEAN|0.27||0.495|TWO_SIDED|95.0|-0.37|0.74|||Longitudinal analysis|||Change at Hour 4: The analysis was performed using longitudinal analysis model with baseline as a covariate.||0.74|-0.37|0.495
72526359|NCT00853112|144583445|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.24|STANDARD_ERROR_OF_MEAN|0.27||0.375|TWO_SIDED|95.0|-0.31|0.8|||Longitudinal analysis|||Change at Hour 4: The analysis was performed using longitudinal analysis model with baseline as a covariate.||0.80|-0.31|0.375
72526360|NCT00853112|144583445|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.25|STANDARD_ERROR_OF_MEAN|0.29||0.392|TWO_SIDED|95.0|-0.34|0.84|||Longitudinal analysis|||Change at Hour 4: The analysis was performed using longitudinal analysis model with baseline as a covariate.||0.84|-0.34|0.392
72526361|NCT00853112|144583446|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-4.8|STANDARD_ERROR_OF_MEAN|3.75||0.21|TWO_SIDED|95.0|-12.47|2.86|||Longitudinal analysis|||mPAP at Hour 1: The analysis was performed using longitudinal analysis model with baseline as a covariate.||2.86|-12.47|0.210
72526362|NCT00853112|144583446|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-4.47|STANDARD_ERROR_OF_MEAN|3.61||0.225|TWO_SIDED|95.0|-11.84|2.9|||Longitudinal analysis|||mPAP at Hour 1: The analysis was performed using longitudinal analysis model with baseline as a covariate.||2.90|-11.84|0.225
72526363|NCT00853112|144583446|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-3.67|STANDARD_ERROR_OF_MEAN|3.73||0.332|TWO_SIDED|95.0|-11.28|3.93|||Longitudinal analysis|||mPAP at Hour 1: The analysis was performed using longitudinal analysis model with baseline as a covariate.||3.93|-11.28|0.332
72526364|NCT00853112|144583446|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.39|STANDARD_ERROR_OF_MEAN|3.76||0.714|TWO_SIDED|95.0|-9.06|6.28|||Longitudinal analysis|||mPAP at Hour 1: The analysis was performed using longitudinal analysis model with baseline as a covariate.||6.28|-9.06|0.714
72526365|NCT00853112|144583446|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-8.01|STANDARD_ERROR_OF_MEAN|3.73||0.04|TWO_SIDED|95.0|-15.63|-0.39|||Longitudinal analysis|||mPAP at Hour 1: The analysis was performed using longitudinal analysis model with baseline as a covariate.||-0.39|-15.63|0.040
72526366|NCT00853112|144583446|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-6.14|STANDARD_ERROR_OF_MEAN|3.37||0.079|TWO_SIDED|95.0|-13.02|0.75|||Longitudinal analysis|||mPAP at Hour 2: The analysis was performed using longitudinal analysis model with baseline as a covariate.||0.75|-13.02|0.079
72526367|NCT00853112|144583446|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.85|STANDARD_ERROR_OF_MEAN|3.24||0.573|TWO_SIDED|95.0|-8.46|4.77|||Longitudinal analysis|||mPAP at Hour 2: The analysis was performed using longitudinal analysis model with baseline as a covariate.||4.77|-8.46|0.573
72526368|NCT00853112|144583446|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-3.67|STANDARD_ERROR_OF_MEAN|3.34||0.28|TWO_SIDED|95.0|-10.5|3.15|||Longitudinal analysis|||mPAP at Hour 2: The analysis was performed using longitudinal analysis model with baseline as a covariate.||3.15|-10.50|0.280
72526369|NCT00853112|144583446|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.39|STANDARD_ERROR_OF_MEAN|3.38||0.684|TWO_SIDED|95.0|-8.28|5.51|||Longitudinal analysis|||mPAP at Hour 2: The analysis was performed using longitudinal analysis model with baseline as a covariate.||5.51|-8.28|0.684
72526370|NCT00853112|144583446|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.17|STANDARD_ERROR_OF_MEAN|3.35||0.021|TWO_SIDED|95.0|-15.01|-1.34|||Longitudinal analysis|||mPAP at Hour 2: Longitudinal analysis was used to analyze p-value and included baseline as a covariate.||-1.34|-15.01|0.021
72526371|NCT00853112|144583446|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.3|STANDARD_ERROR_OF_MEAN|3.7||0.727|TWO_SIDED|95.0|-8.86|6.25|||Longitudinal analysis|||mPAP at Hour 3: The analysis was performed using longitudinal analysis model with baseline as a covariate.||6.25|-8.86|0.727
72526372|NCT00853112|144583446|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-4.85|STANDARD_ERROR_OF_MEAN|3.56||0.183|TWO_SIDED|95.0|-12.12|2.42|||Longitudinal analysis|||mPAP at Hour 3: The analysis was performed using longitudinal analysis model with baseline as a covariate.||2.42|-12.12|0.183
72526373|NCT00853112|144583446|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-6.01|STANDARD_ERROR_OF_MEAN|3.67||0.112|TWO_SIDED|95.0|-13.51|1.49|||Longitudinal analysis|||mPAP at Hour 3: The analysis was performed using longitudinal analysis model with baseline as a covariate.||1.49|-13.51|0.112
72526374|NCT00853112|144583446|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.34|STANDARD_ERROR_OF_MEAN|3.71||0.928|TWO_SIDED|95.0|-7.91|7.23|||Longitudinal analysis|||mPAP at Hour 3: The analysis was performed using longitudinal analysis model with baseline as a covariate.||7.23|-7.91|0.928
72526375|NCT00853112|144583446|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-9.01|STANDARD_ERROR_OF_MEAN|3.68||0.02|TWO_SIDED|95.0|-16.52|-1.5|||Longitudinal analysis|||mPAP at Hour 3: The analysis was performed using longitudinal analysis model with baseline as a covariate.||-1.50|-16.52|0.020
72526376|NCT00853112|144583446|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-5.8|STANDARD_ERROR_OF_MEAN|3.79||0.136|TWO_SIDED|95.0|-13.55|1.94|||Longitudinal analysis|||mPAP at Hour 4: The analysis was performed using longitudinal analysis model with baseline as a covariate.||1.94|-13.55|0.136
72526377|NCT00853112|144583446|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-3.82|STANDARD_ERROR_OF_MEAN|3.65||0.303|TWO_SIDED|95.0|-11.27|3.63|||Longitudinal analysis|||mPAP at Hour 4: The analysis was performed using longitudinal analysis model with baseline as a covariate.||3.63|-11.27|0.303
72526378|NCT00853112|144583446|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-5.17|STANDARD_ERROR_OF_MEAN|3.77||0.18|TWO_SIDED|95.0|-12.87|2.52|||Longitudinal analysis|||mPAP at Hour 4: The analysis was performed using longitudinal analysis model with baseline as a covariate.||2.52|-12.87|0.180
72526379|NCT00853112|144583446|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-2.56|STANDARD_ERROR_OF_MEAN|3.8||0.506|TWO_SIDED|95.0|-10.31|5.2|||Longitudinal analysis|||mPAP at Hour 4: The analysis was performed using longitudinal analysis model with baseline as a covariate.||5.20|-10.31|0.506
72526380|NCT00853112|144583446|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-8.84|STANDARD_ERROR_OF_MEAN|3.77||0.026|TWO_SIDED|95.0|-16.54|-1.14|||Longitudinal analysis|||mPAP at Hour 4: The analysis was performed using longitudinal analysis model with baseline as a covariate.||-1.14|-16.54|0.026
72526381|NCT01553591|144583454|SUPERIORITY|||||||0.014||||||Significance level of 0.025|Chi-square test statistic|||The family-wise error rate was controlled by Bonferroni adjustment for each active dose versus placebo.||||0.014
72526382|NCT01553591|144583454|SUPERIORITY|||||||0.004||||||Significance level of 0.025|Chi-square test statistic|||The family-wise error rate was controlled by Bonferroni adjustment for each active dose versus placebo.||||0.004
72571314|NCT00446199|144671221|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.2|||<|0.0001||95.0|-20.2|-8.1||significance level of 1.7% is used to adjust (Bonferroni) for the comparison of three active arms with Placebo.|ANCOVA|treatment, center and baseline value used as covariate|Change in active treatment arm minus change in placebo arm|Comparison between DRSP/E2 (0.25mg/0.5mg) and Placebo with respect to a shift in the distribution of the end point. Null hypothesis: The mean change from baseline to week 4 is identical in both arms, alternative: there is a difference in the mean change from baseline.||-8.1|-20.2|<0.0001
72571315|NCT00446199|144671221|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.6||||0.0054||95.0|-14.6|-2.5||significance level of 1.7% is used to adjust (Bonferroni) for the comparison of three active arms with Placebo.|ANCOVA|treatment, center and baseline value used as covariate|Change in active treatment arm minus change in placebo arm|Comparison between E2 (0.3mg) and Placebo with respect to a shift in the distribution of the end point. Null hypothesis: The mean change from baseline to week 4 is identical in both arms, alternative: there is a difference in the mean change from baseline.||-2.5|-14.6|0.0054
72526383|NCT01553591|144583455|SUPERIORITY|||||||0.112||||||Significance level of 0.025|Chi-square test statistic|||The family-wise error rate was controlled by Bonferroni adjustment for each active dose versus placebo.||||0.112
72526384|NCT01553591|144583455|SUPERIORITY||||||<|0.001||||||Significance level of 0.025|Chi-square test statistic|||The family-wise error rate was controlled by Bonferroni adjustment for each active dose versus placebo.||||<0.001
72526385|NCT00397631|144583501|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.89|STANDARD_ERROR_OF_MEAN|0.12|<|0.001||95.0|-1.13|-0.65|||ANCOVA|Model terms: treatment, baseline HbA1c||||-0.65|-1.13|<0.001
72526386|NCT00397631|144583502|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-22.8|STANDARD_ERROR_OF_MEAN|3.87|<|0.001||95.0|-30.4|-15.2|||ANCOVA|Model terms: treatment, baseline FPG||||-15.2|-30.4|<0.001
72526387|NCT00397631|144583503|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-44.7|STANDARD_ERROR_OF_MEAN|6.37|<|0.001||95.0|-57.2|32.2|||ANCOVA|Model terms: treatment, baseline 2-hour PPG||||32.2|-57.2|<0.001
72526388|NCT02202161|144583504|SUPERIORITY_OR_OTHER|An analysis of covariance (ANCOVA) model with a fixed effect term for treatment was fitted with the post-Baseline pharmacodynamic parameter value minus Baseline (Day -1 parameter value) as the dependent variable and Baseline as a covariate.|Mean Difference (Net)|-1.17|||||TWO_SIDED|95.0|-25.61|23.27|||||Comparison for fasting, Day 7|An estimation approach was used.||23.27|-25.61|
72526389|NCT02202161|144583504|SUPERIORITY_OR_OTHER|An analysis of covariance (ANCOVA) model with a fixed effect term for treatment was fitted with the post-Baseline pharmacodynamic parameter value minus Baseline (Day -1 parameter value) as the dependent variable and Baseline as a covariate.|Mean Difference (Net)|13.22|||||TWO_SIDED|95.0|-9.84|36.27|||||Comparison for fasting, Day 7|An estimation approach was used.||36.27|-9.84|
72526390|NCT02202161|144583504|SUPERIORITY_OR_OTHER|An analysis of covariance (ANCOVA) model with a fixed effect term for treatment was fitted with the post-Baseline pharmacodynamic parameter value minus Baseline (Day -1 parameter value) as the dependent variable and Baseline as a covariate.|Mean Difference (Net)|-21.77|||||TWO_SIDED|95.0|-41.43|-2.1|||||Comparison for fasting, Day 7|An estimation approach was used.||-2.10|-41.43|
72526391|NCT02202161|144583504|SUPERIORITY_OR_OTHER|An analysis of covariance (ANCOVA) model with a fixed effect term for treatment was fitted with the post-Baseline pharmacodynamic parameter value minus Baseline (Day -1 parameter value) as the dependent variable and Baseline as a covariate.|Mean Difference (Net)|-23.1|||||TWO_SIDED|95.0|-42.63|-3.57|||||Comparison for fasting, Day 7|An estimation approach was used.||-3.57|-42.63|
72407000|NCT04269161|144322760|OTHER|The difference is defined as the difference of proportion of time in the target range of SpO2 in modes, automatic minus manual. Our study is a 2-treatment, 24-period crossover design that accounts for first-order carryover effects, indicating a slightly higher power than a 2x2. Each subject acted as their own control. The study was defined as intention to treat, such that manual adjustments during the automated arm would be included in that arm.|Mean Difference (Net)|0.018||||0.02|TWO_SIDED|95.0|0.003|0.034||The threshold for statistical significance is p=.05|t-test, 2 sided|Two-sample t test with equal variances. Linear mixed model patient random effects, adjusted for site, sex, race, weight, gestational age, bed type.|Treatment difference = automatic - manual. A positive number favors automatic.|The difference in the proportion of time in the target saturation is calculated between the automatic and manual models. For each 6-hour time block, we calculate the proportion of time the patient stays within the prescribed SpO2 range.||.034|0.003|.02
72407001|NCT04368429|144322762|NON_INFERIORITY|The non-inferiority was demonstrated if the lower limit of the 2-sided 95% Confidence Interval (CI) of the difference in percentage was greater than (\>) -10% for the serogroup A.|Difference in percentage|20.27|||||TWO_SIDED|95.0|11.38|28.75|||||95% CI of the difference in percentage was calculated from the Wilson Score method without continuity correction.|Serogroup A||28.75|11.38|
72407002|NCT04368429|144322762|NON_INFERIORITY|The non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference in percentage was \>-10% for the serogroup C.|Difference in percentage|33.98|||||TWO_SIDED|95.0|26.2|41.5|||||95% CI of the difference in percentage was calculated from the Wilson Score method without continuity correction.|Serogroup C||41.50|26.20|
72407003|NCT04368429|144322762|NON_INFERIORITY|The non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference in percentage was \>-10% for the serogroup Y.|Difference in percentage|34.22|||||TWO_SIDED|95.0|26.66|41.64|||||95% CI of the difference in percentage was calculated from the Wilson Score method without continuity correction.|Serogroup Y||41.64|26.66|
72526392|NCT02202161|144583504|SUPERIORITY_OR_OTHER|An analysis of covariance (ANCOVA) model with a fixed effect term for treatment was fitted with the post-Baseline pharmacodynamic parameter value minus Baseline (Day -1 parameter value) as the dependent variable and Baseline as a covariate.|Mean Difference (Net)|-11.79|||||TWO_SIDED|95.0|-30.85|7.28|||||Comparison for fasting, Day 7|An estimation approach was used.||7.28|-30.85|
72526393|NCT02202161|144583504|SUPERIORITY_OR_OTHER|An analysis of covariance (ANCOVA) model with a fixed effect term for treatment was fitted with the post-Baseline pharmacodynamic parameter value minus Baseline (Day -1 parameter value) as the dependent variable and Baseline as a covariate.|Mean Difference (Net)|-10.04|||||TWO_SIDED|95.0|-27.66|7.57|||||Comparison for fasting, Day 7|An estimation approach was used.||7.57|-27.66|
72526394|NCT02202161|144583504|SUPERIORITY_OR_OTHER|An analysis of covariance (ANCOVA) model with a fixed effect term for treatment was fitted with the post-Baseline pharmacodynamic parameter value minus Baseline (Day -1 parameter value) as the dependent variable and Baseline as a covariate.|Mean Difference (Net)|-15.14|||||TWO_SIDED|95.0|-37.72|7.43|||||Comparison for WM AUC(0-24 hour), Day 7|An estimation approach was used.||7.43|-37.72|
72576762|NCT00261443|144680647|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.04||||0.596|TWO_SIDED|95.0|-0.18|0.1||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 8 Comparison||0.10|-0.18|0.596
72526395|NCT02202161|144583504|SUPERIORITY_OR_OTHER|An analysis of covariance (ANCOVA) model with a fixed effect term for treatment was fitted with the post-Baseline pharmacodynamic parameter value minus Baseline (Day -1 parameter value) as the dependent variable and Baseline as a covariate.|Mean Difference (Net)|-2.1|||||TWO_SIDED|95.0|-23.66|19.45|||||Comparison for WM AUC(0-24 hour), Day 7|An estimation approach was used.||19.45|-23.66|
72526396|NCT02202161|144583504|SUPERIORITY_OR_OTHER|An analysis of covariance (ANCOVA) model with a fixed effect term for treatment was fitted with the post-Baseline pharmacodynamic parameter value minus Baseline (Day -1 parameter value) as the dependent variable and Baseline as a covariate.|Mean Difference (Net)|-20.66|||||TWO_SIDED|95.0|-38.75|-2.57|||||Comparison for WM AUC(0-24 hour), Day 7|An estimation approach was used.||-2.57|-38.75|
72526397|NCT02202161|144583504|SUPERIORITY_OR_OTHER|An analysis of covariance (ANCOVA) model with a fixed effect term for treatment was fitted with the post-Baseline pharmacodynamic parameter value minus Baseline (Day -1 parameter value) as the dependent variable and Baseline as a covariate.|Mean Difference (Net)|-21.7|||||TWO_SIDED|95.0|-39.7|-3.71|||||Comparison for WM AUC(0-24 hour), Day 7|An estimation approach was used.||-3.71|-39.70|
72526398|NCT02202161|144583504|SUPERIORITY_OR_OTHER|An analysis of covariance (ANCOVA) model with a fixed effect term for treatment was fitted with the post-Baseline pharmacodynamic parameter value minus Baseline (Day -1 parameter value) as the dependent variable and Baseline as a covariate.|Mean Difference (Net)|-10.62|||||TWO_SIDED|95.0|-28.62|7.38|||||Comparison for WM AUC(0-24 hour), Day 7|An estimation approach was used.||7.38|-28.62|
72526399|NCT02202161|144583504|SUPERIORITY_OR_OTHER|An analysis of covariance (ANCOVA) model with a fixed effect term for treatment was fitted with the post-Baseline pharmacodynamic parameter value minus Baseline (Day -1 parameter value) as the dependent variable and Baseline as a covariate.|Mean Difference (Net)|-26.03|||||TWO_SIDED|95.0|-41.94|-10.12|||||Comparison for WM AUC(0-24 hour), Day 7|An estimation approach was used.||-10.12|-41.94|
72407004|NCT04368429|144322762|NON_INFERIORITY|The non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference in percentage was \>-10% for the serogroup W.|Difference in percentage|38.19|||||TWO_SIDED|95.0|28.93|46.53|||||95% CI of the difference in percentage was calculated from the Wilson Score method without continuity correction.|Serogroup W||46.53|28.93|
72526400|NCT02202161|144583504|SUPERIORITY_OR_OTHER|An analysis of covariance (ANCOVA) model with a fixed effect term for treatment was fitted with the post-Baseline pharmacodynamic parameter value minus Baseline (Day -1 parameter value) as the dependent variable and Baseline as a covariate.|Mean Difference (Net)|-12.1|||||TWO_SIDED|95.0|-33.56|9.36|||||Comparison for fasting, Day 14|An estimation approach was used.||9.36|-33.56|
72526401|NCT02202161|144583504|SUPERIORITY_OR_OTHER|An analysis of covariance (ANCOVA) model with a fixed effect term for treatment was fitted with the post-Baseline pharmacodynamic parameter value minus Baseline (Day -1 parameter value) as the dependent variable and Baseline as a covariate.|Mean Difference (Net)|4.33|||||TWO_SIDED|95.0|-15.91|24.57|||||Comparison for fasting, Day 14|An estimation approach was used.||24.57|-15.91|
72526402|NCT02202161|144583504|SUPERIORITY_OR_OTHER|An analysis of covariance (ANCOVA) model with a fixed effect term for treatment was fitted with the post-Baseline pharmacodynamic parameter value minus Baseline (Day -1 parameter value) as the dependent variable and Baseline as a covariate.|Mean Difference (Net)|-25.29|||||TWO_SIDED|95.0|-42.56|-8.02|||||Comparison for fasting, Day 14|An estimation approach was used.||-8.02|-42.56|
72526403|NCT02202161|144583504|SUPERIORITY_OR_OTHER|An analysis of covariance (ANCOVA) model with a fixed effect term for treatment was fitted with the post-Baseline pharmacodynamic parameter value minus Baseline (Day -1 parameter value) as the dependent variable and Baseline as a covariate.|Mean Difference (Net)|-19.97|||||TWO_SIDED|95.0|-37.12|-2.82|||||Comparison for fasting, Day 14|An estimation approach was used.||-2.82|-37.12|
72526404|NCT02202161|144583504|SUPERIORITY_OR_OTHER|An analysis of covariance (ANCOVA) model with a fixed effect term for treatment was fitted with the post-Baseline pharmacodynamic parameter value minus Baseline (Day -1 parameter value) as the dependent variable and Baseline as a covariate.|Mean Difference (Net)|-21.82|||||TWO_SIDED|95.0|-38.56|-5.08|||||Comparison for fasting, Day 14|An estimation approach was used.||-5.08|-38.56|
72526405|NCT02202161|144583504|SUPERIORITY_OR_OTHER|An analysis of covariance (ANCOVA) model with a fixed effect term for treatment was fitted with the post-Baseline pharmacodynamic parameter value minus Baseline (Day -1 parameter value) as the dependent variable and Baseline as a covariate.|Mean Difference (Net)|-18.01|||||TWO_SIDED|95.0|-33.48|-2.55|||||Comparison for fasting, Day 14|An estimation approach was used.||-2.55|-33.48|
72526406|NCT02202161|144583504|SUPERIORITY_OR_OTHER|An analysis of covariance (ANCOVA) model with a fixed effect term for treatment was fitted with the post-Baseline pharmacodynamic parameter value minus Baseline (Day -1 parameter value) as the dependent variable and Baseline as a covariate.|Mean Difference (Net)|-11.2|||||TWO_SIDED|95.0|-33.21|10.81|||||Comparison for WM AUC(0-24 hour), Day 14|An estimation approach was used.||10.81|-33.21|
72526407|NCT02202161|144583504|SUPERIORITY_OR_OTHER|An analysis of covariance (ANCOVA) model with a fixed effect term for treatment was fitted with the post-Baseline pharmacodynamic parameter value minus Baseline (Day -1 parameter value) as the dependent variable and Baseline as a covariate.|Mean Difference (Net)|4.8|||||TWO_SIDED|95.0|-16.22|25.81|||||Comparison for WM AUC(0-24 hour), Day 14|An estimation approach was used.||25.81|-16.22|
72526408|NCT02202161|144583504|SUPERIORITY_OR_OTHER|An analysis of covariance (ANCOVA) model with a fixed effect term for treatment was fitted with the post-Baseline pharmacodynamic parameter value minus Baseline (Day -1 parameter value) as the dependent variable and Baseline as a covariate.|Mean Difference (Net)|-15.23|||||TWO_SIDED|95.0|-32.86|2.41|||||Comparison for WM AUC(0-24 hour), Day 14|An estimation approach was used.||2.41|-32.86|
72526409|NCT02202161|144583504|SUPERIORITY_OR_OTHER|An analysis of covariance (ANCOVA) model with a fixed effect term for treatment was fitted with the post-Baseline pharmacodynamic parameter value minus Baseline (Day -1 parameter value) as the dependent variable and Baseline as a covariate.|Mean Difference (Net)|-17.01|||||TWO_SIDED|95.0|-34.56|0.53|||||Comparison for WM AUC(0-24 hour), Day 14|An estimation approach was used.||0.53|-34.56|
72571316|NCT00446199|144671222|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.069|||<|0.0001||95.0|-1.28|-0.859||significance level of 1.7% is used to adjust (Bonferroni) for the comparison of three active arms with Placebo.|ANCOVA|treatment, center and baseline value used as covariate|Change in active treatment arm minus change in placebo arm|Comparison between DRSP/E2 (0.5mg/0.5mg) and Placebo with respect to a shift in the distribution of the end point. Null hypothesis: The mean change from baseline to week 12 is identical in both arms, alternative: there is a difference in the mean change from baseline.||-0.859|-1.280|<0.0001
72526410|NCT02202161|144583504|SUPERIORITY_OR_OTHER|An analysis of covariance (ANCOVA) model with a fixed effect term for treatment was fitted with the post-Baseline pharmacodynamic parameter value minus Baseline (Day -1 parameter value) as the dependent variable and Baseline as a covariate.|Mean Difference (Net)|-23.94|||||TWO_SIDED|95.0|-41.49|-6.39|||||Comparison for WM AUC(0-24 hour), Day 14|An estimation approach was used.||-6.39|-41.49|
72526411|NCT02202161|144583504|SUPERIORITY_OR_OTHER|An analysis of covariance (ANCOVA) model with a fixed effect term for treatment was fitted with the post-Baseline pharmacodynamic parameter value minus Baseline (Day -1 parameter value) as the dependent variable and Baseline as a covariate.|Mean Difference (Net)|-19.45|||||TWO_SIDED|95.0|-34.96|-3.93|||||Comparison for WM AUC(0-24 hour), Day 14|An estimation approach was used.||-3.93|-34.96|
72526412|NCT02202161|144583519|SUPERIORITY_OR_OTHER|Each GSK2330672 dose level was compared to placebo using an analysis of variance (ANOVA) model of log-transformed values.|Ratio|1.17|||||TWO_SIDED|90.0|0.92|1.49|||||Mean and confidence interval (CI) for the difference in least squares means (Active-Placebo) are back-transformed to form the point estimate and associated CI for the ratio of geometric means.|||1.49|0.92|
72526413|NCT02202161|144583519|SUPERIORITY_OR_OTHER|Each GSK2330672 dose level was compared to placebo using an analysis of variance (ANOVA) model of log-transformed values.|Ratio|1.11|||||TWO_SIDED|90.0|0.89|1.38|||||Mean and CI for the difference in least squares means (Active-Placebo) are back-transformed to form the point estimate and associated CI for the ratio of geometric means.|||1.38|0.89|
72526414|NCT02202161|144583519|SUPERIORITY_OR_OTHER|Each GSK2330672 dose level was compared to placebo using an analysis of variance (ANOVA) model of log-transformed values.|Ratio|1.05|||||TWO_SIDED|90.0|0.87|1.27|||||Mean and CI for the difference in least squares means (Active-Placebo) are back-transformed to form the point estimate and associated CI for the ratio of geometric means.|||1.27|0.87|
72526415|NCT02202161|144583519|SUPERIORITY_OR_OTHER|Each GSK2330672 dose level was compared to placebo using an analysis of variance (ANOVA) model of log-transformed values.|Ratio|1.25|||||TWO_SIDED|90.0|1.03|1.52|||||Mean and CI for the difference in least squares means (Active-Placebo) are back-transformed to form the point estimate and associated CI for the ratio of geometric means.|||1.52|1.03|
72526416|NCT02202161|144583519|SUPERIORITY_OR_OTHER|Each GSK2330672 dose level was compared to placebo using an analysis of variance (ANOVA) model of log-transformed values.|Ratio|1.25|||||TWO_SIDED|90.0|1.04|1.5|||||Mean and CI for the difference in least squares means (Active-Placebo) are back-transformed to form the point estimate and associated CI for the ratio of geometric means.|||1.50|1.04|
72571317|NCT00446199|144671222|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.803|||<|0.0001||95.0|-1.013|-0.593||significance level of 1.7% is used to adjust (Bonferroni) for the comparison of three active arms with Placebo.|ANCOVA|treatment, center and baseline value used as covariate|Change in active treatment arm minus change in placebo arm|Comparison between DRSP/E2 (0.25mg/0.5mg) and Placebo with respect to a shift in the distribution of the end point. Null hypothesis: The mean change from baseline to week 12 is identical in both arms, alternative: there is a difference in the mean change from baseline.||-0.593|-1.013|<0.0001
72571318|NCT00446199|144671222|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.361||||0.0007||95.0|-0.57|-0.152||significance level of 1.7% is used to adjust (Bonferroni) for the comparison of three active arms with Placebo.|ANCOVA|treatment, center and baseline value used as covariate|Change in active treatment arm minus change in placebo arm|Comparison between E2 (0.3mg) and Placebo with respect to a shift in the distribution of the end point. Null hypothesis: The mean change from baseline to week 12 is identical in both arms, alternative: there is a difference in the mean change from baseline.||-0.152|-0.570|0.0007
72571319|NCT00446199|144671223|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.635|||<|0.0001||95.0|-0.813|-0.458||Significance level of 1.7% is used to adjust (Bonferroni) for the comparison of three active arms with Placebo.|ANCOVA|Treatment, Center, and Baseline value used as covariate||Comparison between DRSP/E2 (0.5mg/0.5mg) and Placebo with respect to a shift in the distribution of the end point. Null hypothesis: The mean change from baseline to week 4 is identical in both arms, alternative: there is a difference in the mean change from baseline.||-0.458|-0.813|<0.0001
72571320|NCT00446199|144671223|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.382|||<|0.0001||95.0|-0.56|-0.205||Significance level of 1.7% is used to adjust (Bonferroni) for the comparison of three active arms with Placebo.|ANCOVA|Treatment, Center, and Baseline value used as covariate||Comparison between DRSP/E2 (0.25mg/0.5mg) and Placebo with respect to a shift in the distribution of the end point. Null hypothesis: The mean change from baseline to week 4 is identical in both arms, alternative: there is a difference in the mean change from baseline.||-0.205|-0.560|<0.0001
72625307|NCT01098747|144780087|SUPERIORITY_OR_OTHER||Difference in proportion|-23.93|||<|0.001|TWO_SIDED|95.0|-36.67|-11.2||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1.5 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-11.20|-36.67|<0.001
72625308|NCT01098747|144780087|SUPERIORITY_OR_OTHER||Difference in proportion|-1.21||||0.483|TWO_SIDED|95.0|-4.12|1.7||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1.5 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||1.70|-4.12|0.483
72526417|NCT02202161|144583519|SUPERIORITY_OR_OTHER|Each GSK2330672 dose level was compared to placebo using an analysis of variance (ANOVA) model of log-transformed values.|Ratio|1.11|||||TWO_SIDED|90.0|0.94|1.31|||||Mean and CI for the difference in least squares means (Active-Placebo) are back-transformed to form the point estimate and associated CI for the ratio of geometric means.|||1.31|0.94|
72625309|NCT01098747|144780087|SUPERIORITY_OR_OTHER||Difference in proportion|-51.93|||<|0.001|TWO_SIDED|95.0|-65.63|-38.22||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||2 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-38.22|-65.63|<0.001
72571321|NCT00446199|144671223|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.204||||0.0233||95.0|-0.381|-0.028||Significance level of 1.7% is used to adjust (Bonferroni) for the comparison of three active arms with Placebo.|ANCOVA|Treatment, Center, and Baseline value used as covariate||Comparison between E2 (0.3) and Placebo with respect to a shift in the distribution of the end point. Null hypothesis: The mean change from baseline to week 4 is identical in both arms, alternative: there is a difference in the mean change from baseline.||-0.028|-0.381|0.0233
72571322|NCT01822574|144671224|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED||||||ANOVA|||A p-value less than 0.05 was considered statistically significant.||||0.001
72571323|NCT01822574|144671225|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANOVA|||A p-value less than 0.05 was considered statistically significant.||||<0.001
72571324|NCT01822574|144671226|SUPERIORITY_OR_OTHER|||||||0.24|TWO_SIDED||||||ANOVA|||A p-value less than 0.05 was considered statistically significant.||||0.240
72526418|NCT02202161|144583521|SUPERIORITY_OR_OTHER|Each GSK2330672 dose level was compared to placebo using an ANOVA model following log-transformation.|Ratio|0.88|||||TWO_SIDED|90.0|0.68|1.13|||||Mean and CI for the difference in least squares means (Active-Placebo) are back-transformed to form the point estimate and associated CI for the ratio of geometric means.|||1.13|0.68|
72571325|NCT00759902|144671258|NON_INFERIORITY_OR_EQUIVALENCE|The 90% confidence intervals for the ratios (test/reference) of the least squares means of the non-transformed parameters Cmax, AUClast, AUCinf, Tmax, λz, and T1/2, were calculated.|mean ratio|123.0||||||90.0|112.9|134.1|||ANOVA|log-transformation||||134.1|112.9|
72571326|NCT00759902|144671260|NON_INFERIORITY_OR_EQUIVALENCE|The 90% confidence intervals for the ratios (test/reference) of the least squares means of the non-transformed parameters Cmax, AUClast, AUCinf, Tmax, λz, and T1/2, were calculated.|mean ratio|101.7||||||90.0|98.5|104.9|||ANOVA|log-transformation||||104.9|98.5|
72526419|NCT02202161|144583521|SUPERIORITY_OR_OTHER|Each GSK2330672 dose level was compared to placebo using an ANOVA model following log-transformation.|Ratio|1.04|||||TWO_SIDED|90.0|0.82|1.31|||||Mean and CI for the difference in least squares means (Active-Placebo) are back-transformed to form the point estimate and associated CI for the ratio of geometric means.|||1.31|0.82|
72407005|NCT01706952|144322772|SUPERIORITY_OR_OTHER|For surgical field grade, we calculated the mean within sides and assessed its difference, reporting a 95% confidence interval as calculated by a Student t test. We used the average per patient over time.||||||0.05|||||||t-test, 2 sided|||Data analysis was performed using SPSS version 13 for Windows (SPSS Inc, Chicago, IL). A power study was per formed with a power of 80% and a clinically significant difference in bleeding between the sides of 20% with a significance level of 5% (p \< 0.05).|"For the primary objective of surgical field grade, we calculated the mean within sides treated with cocaine vs adrenaline and assessed its difference, reporting a 95% con- fidence interval as calculated by a Student t test. As all of these values were measured over time, we used the average per patient over time. The total blood loss per side within subjects was also calculated, with 95% confidence interval again calculated by a Student t test. Once again, we took the average per patient over time as the main outcome.~Finally, we used a linear regression with surgical field improvement as the outcome and HR, MAP, or etCO2 as covariates, to investigate which variables may be related to the outcome. As these measures were taken over time, we used repeated measures analysis to investigate how these items correlate over time.~In addition to the operating surgeon, the statistician was blinded to the vasoconstrictor allocation."|||0.05
72407006|NCT02984020|144322792|OTHER||Odds Ratio (OR)|0.77|||<|0.0001||95.0|0.69|0.86|||Regression, Logistic|Multiple logistic regression including total treatment duration of Xeljanz as factor||||0.86|0.69|<0.0001
72407007|NCT02984020|144322792|OTHER||Odds Ratio (OR)|2.43|||<|0.0001||95.0|1.64|3.59|||Regression, Logistic|Multiple logistic regression including other past/present disease as factor||||3.59|1.64|<0.0001
72407008|NCT02984020|144322803|OTHER||Odds Ratio (OR)|1.42||||0.0053|TWO_SIDED|95.0|1.11|1.82|||Regression, Logistic|Multiple logistic regression including total duration of treatment with Xeljanz as factor||||1.82|1.11|0.0053
72407009|NCT02610868|144322808|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
72407010|NCT02610868|144322808|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
72407011|NCT02610868|144322808|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
72407012|NCT02610868|144322808|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
72571327|NCT00759902|144671261|NON_INFERIORITY_OR_EQUIVALENCE|The 90% confidence intervals for the ratios (test/reference) of the least squares means of the non-transformed parameters Cmax, AUClast, AUCinf, Tmax, λz, and T1/2, were calculated.|mean ratio|102.9||||||90.0|99.3|106.5|||ANOVA|log-transformation||||106.5|99.3|
72407013|NCT02610868|144322808|SUPERIORITY|||||||0.0006|||||||ANCOVA|||||||0.0006
72407014|NCT02610868|144322808|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
72407015|NCT02610868|144322808|SUPERIORITY|||||||0.1131|||||||ANCOVA|||||||0.1131
72407016|NCT02610868|144322808|SUPERIORITY|||||||0.0026|||||||ANCOVA|||||||0.0026
72407017|NCT02610868|144322808|SUPERIORITY|||||||0.2569|||||||ANCOVA|||||||0.2569
72407018|NCT02610868|144322809|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
72407019|NCT02610868|144322809|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
72407020|NCT02610868|144322809|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
72571328|NCT05071313|144671282|NON_INFERIORITY|Non-inferiority of Group 2 versus Group 1 in terms of the HI antibody titers against all four influenza vaccine strains 28 days after vaccination with fluzone, using a non-inferiority margin of 1.5 for the GMT ratio (Group 2/Group 1).|Geometric Mean Ratio|1.01|||||TWO_SIDED|95.0|0.89|1.14||||||A/Victoria||1.14|0.89|
72571329|NCT05071313|144671282|NON_INFERIORITY|Non-inferiority of Group 2 versus Group 1 in terms of the HI antibody titers against all four influenza vaccine strains 28 days after vaccination with fluzone, using a non-inferiority margin of 1.5 for the GMT ratio (Group 2/Group 1).|Geometric Mean Ratio|1.11|||||TWO_SIDED|95.0|0.97|1.28||||||A/Tasmania||1.28|0.97|
72407021|NCT02610868|144322809|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
72407022|NCT02610868|144322809|SUPERIORITY|||||||0.313|||||||ANCOVA|||||||0.3130
72407023|NCT02610868|144322809|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
72407024|NCT02610868|144322809|SUPERIORITY|||||||0.1054|||||||ANCOVA|||||||0.1054
72407025|NCT02610868|144322809|SUPERIORITY|||||||0.0002|||||||ANCOVA|||||||0.0002
72407026|NCT02610868|144322809|SUPERIORITY|||||||0.1663|||||||ANCOVA|||||||0.1663
72407027|NCT02610868|144322811|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
72407028|NCT02610868|144322811|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
72407029|NCT02610868|144322811|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
72407030|NCT02610868|144322811|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
72407031|NCT02610868|144322811|SUPERIORITY|||||||0.11|||||||ANCOVA|||||||0.1100
72407032|NCT02610868|144322811|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
72407033|NCT02610868|144322811|SUPERIORITY|||||||1|||||||ANCOVA|||||||1.0000
72407034|NCT02610868|144322811|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
72407035|NCT02610868|144322811|SUPERIORITY|||||||0.029|||||||ANCOVA|||||||0.0290
72407036|NCT02610868|144322812|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
72407037|NCT02610868|144322812|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
72407038|NCT02610868|144322812|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
72407039|NCT02610868|144322812|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
72407040|NCT02610868|144322812|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
72407041|NCT02610868|144322812|SUPERIORITY|||||||0.0003|||||||ANCOVA|||||||0.0003
72407042|NCT02610868|144322812|SUPERIORITY|||||||0.9016|||||||ANCOVA|||||||0.9016
72407043|NCT02610868|144322812|SUPERIORITY|||||||0.0753|||||||ANCOVA|||||||0.0753
72407044|NCT02610868|144322812|SUPERIORITY|||||||0.4992|||||||ANCOVA|||||||0.4992
72407045|NCT02610868|144322813|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
72407046|NCT02610868|144322813|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
72407047|NCT02610868|144322813|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
72407048|NCT02610868|144322813|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
72407049|NCT02610868|144322813|SUPERIORITY|||||||0.4567|||||||ANCOVA|||||||0.4567
72407050|NCT02610868|144322813|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
72407051|NCT02610868|144322813|SUPERIORITY|||||||0.8115|||||||ANCOVA|||||||0.8115
72407052|NCT02610868|144322813|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
72407053|NCT02610868|144322813|SUPERIORITY|||||||0.3282|||||||ANCOVA|||||||0.3282
72407054|NCT02610868|144322815|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
72526420|NCT02202161|144583521|SUPERIORITY_OR_OTHER|Each GSK2330672 dose level was compared to placebo using an ANOVA model following log-transformation.|Ratio|1.04|||||TWO_SIDED|90.0|0.85|1.26|||||Mean and CI for the difference in least squares means (Active-Placebo) are back-transformed to form the point estimate and associated CI for the ratio of geometric means.|||1.26|0.85|
72526421|NCT02202161|144583521|SUPERIORITY_OR_OTHER|Each GSK2330672 dose level was compared to placebo using an ANOVA model following log-transformation.|Ratio|1.19|||||TWO_SIDED|90.0|0.97|1.45|||||Mean and CI for the difference in least squares means (Active-Placebo) are back-transformed to form the point estimate and associated CI for the ratio of geometric means.|||1.45|0.97|
72526422|NCT02202161|144583521|SUPERIORITY_OR_OTHER|Each GSK2330672 dose level was compared to placebo using an ANOVA model following log-transformation.|Ratio|1.23|||||TWO_SIDED|90.0|1.01|1.49|||||Mean and CI for the difference in least squares means (Active-Placebo) are back-transformed to form the point estimate and associated CI for the ratio of geometric means.|||1.49|1.01|
72526423|NCT02202161|144583521|SUPERIORITY_OR_OTHER|Each GSK2330672 dose level was compared to placebo using an ANOVA model following log-transformation.|Ratio|1.24|||||TWO_SIDED|90.0|1.04|1.48|||||Mean and CI for the difference in least squares means (Active-Placebo) are back-transformed to form the point estimate and associated CI for the ratio of geometric means.|||1.48|1.04|
72526424|NCT02202161|144583522|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|1.03|||||TWO_SIDED|95.0|0.91|1.17|||||Comparison for Day 7, cholesterol|An estimation approach was used.||1.17|0.91|
72526425|NCT02202161|144583522|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.88|||||TWO_SIDED|95.0|0.78|0.98|||||Comparison for Day 7, cholesterol|An estimation approach was used.||0.98|0.78|
72526426|NCT02202161|144583522|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.86|||||TWO_SIDED|95.0|0.78|0.95|||||Comparison for Day 7, cholesterol|An estimation approach was used.||0.95|0.78|
72526427|NCT02202161|144583522|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.75|||||TWO_SIDED|95.0|0.68|0.83|||||Comparison for Day 7, cholesterol|An estimation approach was used.||0.83|0.68|
72526428|NCT02202161|144583522|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.83|||||TWO_SIDED|95.0|0.76|0.92|||||Comparison for Day 7, cholesterol|An estimation approach was used.||0.92|0.76|
72526429|NCT02202161|144583522|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|1.01|||||TWO_SIDED|95.0|0.92|1.1|||||Comparison for Day 7, cholesterol|An estimation approach was used.||1.10|0.92|
72526430|NCT02202161|144583522|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|1.07|||||TWO_SIDED|95.0|0.95|1.19|||||Comparison for Day 7, HDL cholesterol|An estimation approach was used.||1.19|0.95|
72526431|NCT02202161|144583522|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|1.04|||||TWO_SIDED|95.0|0.94|1.16|||||Comparison for Day 7, HDL cholesterol|An estimation approach was used.||1.16|0.94|
72571330|NCT05071313|144671282|NON_INFERIORITY|Non-inferiority of Group 2 versus Group 1 in terms of the HI antibody titers against all four influenza vaccine strains 28 days after vaccination with fluzone, using a non-inferiority margin of 1.5 for the GMT ratio (Group 2/Group 1).|Geometric Mean Ratio|0.91|||||TWO_SIDED|95.0|0.79|1.05||||||B/Washington||1.05|0.79|
72571331|NCT05071313|144671282|NON_INFERIORITY|Non-inferiority of Group 2 versus Group 1 in terms of the HI antibody titers against all four influenza vaccine strains 28 days after vaccination with fluzone, using a non-inferiority margin of 1.5 for the GMT ratio (Group 2/Group 1).|Geometric Mean Ratio|0.97||||||95.0|0.85|1.1||||||B/Phuket||1.10|0.85|
72407055|NCT02610868|144322815|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
72526432|NCT02202161|144583522|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.96|||||TWO_SIDED|95.0|0.88|1.05|||||Comparison for Day 7, HDL cholesterol|An estimation approach was used.||1.05|0.88|
72526433|NCT02202161|144583522|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.98|||||TWO_SIDED|95.0|0.89|1.07|||||Comparison for Day 7, HDL cholesterol|An estimation approach was used.||1.07|0.89|
72526434|NCT02202161|144583522|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|1.07|||||TWO_SIDED|95.0|0.98|1.17|||||Comparison for Day 7, HDL cholesterol|An estimation approach was used.||1.17|0.98|
72526435|NCT02202161|144583522|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.97|||||TWO_SIDED|95.0|0.9|1.05|||||Comparison for Day 7, HDL cholesterol|An estimation approach was used.||1.05|0.90|
72526436|NCT02202161|144583522|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.95|||||TWO_SIDED|95.0|0.8|1.13|||||Comparison for Day 7, LDL cholesterol|An estimation approach was used.||1.13|0.80|
72526437|NCT02202161|144583522|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.76|||||TWO_SIDED|95.0|0.65|0.9|||||Comparison for Day 7, LDL cholesterol|An estimation approach was used.||0.90|0.65|
72571332|NCT03107026|144671297|SUPERIORITY||Mean Difference (Final Values)|-0.29|STANDARD_ERROR_OF_MEAN|0.187||0.1187|TWO_SIDED|95.0|-0.66|0.08|||Mixed Models Analysis|||||0.08|-0.66|0.1187
72526438|NCT02202161|144583522|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.74|||||TWO_SIDED|95.0|0.64|0.85|||||Comparison for Day 7, LDL cholesterol|An estimation approach was used.||0.85|0.64|
72407056|NCT02610868|144322815|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
72625310|NCT01098747|144780087|SUPERIORITY_OR_OTHER||Difference in proportion|-3.61||||0.174|TWO_SIDED|95.0|-7.97|0.75||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||2 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||0.75|-7.97|0.174
72625311|NCT01098747|144780087|SUPERIORITY_OR_OTHER||Difference in proportion|-66.58|||<|0.001|TWO_SIDED|95.0|-79.8|-53.35||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||3 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-53.35|-79.80|<0.001
72625312|NCT01098747|144780087|SUPERIORITY_OR_OTHER||Difference in proportion|-3.75||||0.24|TWO_SIDED|95.0|-9.38|1.89||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||3 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||1.89|-9.38|0.240
72526439|NCT02202161|144583522|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.59|||||TWO_SIDED|95.0|0.51|0.69|||||Comparison for Day 7, LDL cholesterol|An estimation approach was used.||0.69|0.51|
72526440|NCT02202161|144583522|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.71|||||TWO_SIDED|95.0|0.62|0.81|||||Comparison for Day 7, LDL cholesterol|An estimation approach was used.||0.81|0.62|
72526441|NCT02202161|144583522|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|1.0|||||TWO_SIDED|95.0|0.89|1.14|||||Comparison for Day 7, LDL cholesterol|An estimation approach was used.||1.14|0.89|
72526442|NCT02202161|144583522|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|1.03|||||TWO_SIDED|95.0|0.88|1.21|||||Comparison for Day 7, non-HDL cholesterol|An estimation approach was used.||1.21|0.88|
72526443|NCT02202161|144583522|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.82|||||TWO_SIDED|95.0|0.71|0.95|||||Comparison for Day 7, non-HDL cholesterol|An estimation approach was used.||0.95|0.71|
72526444|NCT02202161|144583522|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.84|||||TWO_SIDED|95.0|0.74|0.95|||||Comparison for Day 7, non-HDL cholesterol|An estimation approach was used.||0.95|0.74|
72526445|NCT02202161|144583522|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.67|||||TWO_SIDED|95.0|0.59|0.76|||||Comparison for Day 7, non-HDL cholesterol|An estimation approach was used.||0.76|0.59|
72526446|NCT02202161|144583522|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.77|||||TWO_SIDED|95.0|0.68|0.87|||||Comparison for Day 7, non-HDL cholesterol|An estimation approach was used.||0.87|0.68|
72526447|NCT02202161|144583522|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|1.02|||||TWO_SIDED|95.0|0.92|1.14|||||Comparison for Day 7, non-HDL cholesterol|An estimation approach was used.||1.14|0.92|
72526448|NCT02202161|144583522|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|1.27|||||TWO_SIDED|95.0|0.97|1.66|||||Comparison for Day 7, triglycerides|An estimation approach was used.||1.66|0.97|
72526449|NCT02202161|144583522|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|1.16|||||TWO_SIDED|95.0|0.9|1.5|||||Comparison for Day 7, triglycerides|An estimation approach was used.||1.50|0.90|
72526450|NCT02202161|144583522|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|1.3|||||TWO_SIDED|95.0|1.06|1.61|||||Comparison for Day 7, triglycerides|An estimation approach was used.||1.61|1.06|
72407057|NCT02610868|144322815|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
72407058|NCT02610868|144322815|SUPERIORITY|||||||0.3786|||||||ANCOVA|||||||0.3786
72407059|NCT02610868|144322815|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
72407060|NCT02610868|144322815|SUPERIORITY|||||||0.7787|||||||ANCOVA|||||||0.7787
72407061|NCT02610868|144322815|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
72526451|NCT02202161|144583522|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|1.19|||||TWO_SIDED|95.0|0.96|1.48|||||Comparison for Day 7, triglycerides|An estimation approach was used.||1.48|0.96|
72526452|NCT02202161|144583522|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|1.15|||||TWO_SIDED|95.0|0.93|1.42|||||Comparison for Day 7, triglycerides|An estimation approach was used.||1.42|0.93|
72526453|NCT02202161|144583522|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.95|||||TWO_SIDED|95.0|0.79|1.16|||||Comparison for Day 7, triglycerides|An estimation approach was used.||1.16|0.79|
72407062|NCT02610868|144322815|SUPERIORITY|||||||0.3825|||||||ANCOVA|||||||0.3825
72526454|NCT02202161|144583522|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|1.0|||||TWO_SIDED|95.0|0.86|1.17|||||Comparison for Day 14, cholesterol|An estimation approach was used.||1.17|0.86|
72526455|NCT02202161|144583522|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.83|||||TWO_SIDED|95.0|0.73|0.96|||||Comparison for Day 14, cholesterol|An estimation approach was used.||0.96|0.73|
72526456|NCT02202161|144583522|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.82|||||TWO_SIDED|95.0|0.73|0.91|||||Comparison for Day 14, cholesterol|An estimation approach was used.||0.91|0.73|
72407063|NCT00667342|144322824|OTHER|The association between response and Ktrans at Week 10 was evaluated.||||||0.0863|||||||Logistic Regression|||||||0.0863
72407064|NCT00667342|144322825|OTHER|The association between response and Vp at Week 10 was evaluated.||||||0.0573|||||||Logistic Regression|||||||0.0573
72407065|NCT00667342|144322826|OTHER|The association between response and Ve at Week 10 was evaluated.||||||0.0863|||||||Logistic Regression|||||||0.0863
72407066|NCT00494494|144322854|NON_INFERIORITY_OR_EQUIVALENCE|Our estimate of a clinically relevant increase is 25 microns. With these specifications, the sample size that is required to have 0.90 power for the comparison between two groups at the two-sided 0.05 significance level is about 10 per group.|Mean Difference (Net)|2.82|STANDARD_DEVIATION|13.8||0.7029|TWO_SIDED|95.0|-3.27|8.91|||Wilcoxon (Mann-Whitney)|||The null hypothesis is that there is no correlation between the 2 groups. Standard methods were used for power calculation to determine the sample size needed to have 0.90 power for the comparison between two groups at the two-sided significance of 0.05.||8.91|-3.27|0.7029
72526457|NCT02202161|144583522|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.74|||||TWO_SIDED|95.0|0.66|0.82|||||Comparison for Day 14, cholesterol|An estimation approach was used.||0.82|0.66|
72526458|NCT02202161|144583522|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.77|||||TWO_SIDED|95.0|0.69|0.86|||||Comparison for Day 14, cholesterol|An estimation approach was used.||0.86|0.69|
72526459|NCT02202161|144583522|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.93|||||TWO_SIDED|95.0|0.84|1.03|||||Comparison for Day 14, cholesterol|An estimation approach was used.||1.03|0.84|
72526460|NCT02202161|144583522|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|1.09|||||TWO_SIDED|95.0|0.99|1.21|||||Comparison for Day 14, HDL cholesterol|An estimation approach was used.||1.21|0.99|
72526461|NCT02202161|144583522|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|1.02|||||TWO_SIDED|95.0|0.93|1.11|||||Comparison for Day 14, HDL cholesterol|An estimation approach was used.||1.11|0.93|
72526462|NCT02202161|144583522|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.97|||||TWO_SIDED|95.0|0.9|1.04|||||Comparison for Day 14, HDL cholesterol|An estimation approach was used.||1.04|0.90|
72526463|NCT02202161|144583522|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.99|||||TWO_SIDED|95.0|0.92|1.06|||||Comparison for Day 14, HDL cholesterol|An estimation approach was used.||1.06|0.92|
72526464|NCT02202161|144583522|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|1.01|||||TWO_SIDED|95.0|0.94|1.08|||||Comparison for Day 14, HDL cholesterol|An estimation approach was used.||1.08|0.94|
72526465|NCT02202161|144583522|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.98|||||TWO_SIDED|95.0|0.92|1.04|||||Comparison for Day 14, HDL cholesterol|An estimation approach was used.||1.04|0.92|
72526466|NCT02202161|144583522|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.85|||||TWO_SIDED|95.0|0.69|1.04|||||Comparison for Day 14, LDL cholesterol|An estimation approach was used.||1.04|0.69|
72526467|NCT02202161|144583522|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.7|||||TWO_SIDED|95.0|0.58|0.85|||||Comparison for Day 14, LDL cholesterol|An estimation approach was used.||0.85|0.58|
72526468|NCT02202161|144583522|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.73|||||TWO_SIDED|95.0|0.62|0.86|||||Comparison for Day 14, LDL cholesterol|An estimation approach was used.||0.86|0.62|
72526469|NCT02202161|144583522|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.6|||||TWO_SIDED|95.0|0.5|0.71|||||Comparison for Day 14, LDL cholesterol|An estimation approach was used.||0.71|0.50|
72407067|NCT00494494|144322855|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.01|STANDARD_DEVIATION|9.56||0.1937|TWO_SIDED|95.0|-2.41|6.43|||Wilcoxon (Mann-Whitney)|||||6.43|-2.41|0.1937
72407068|NCT00494494|144322856|SUPERIORITY_OR_OTHER||Mean Difference (Net)|6.7|STANDARD_DEVIATION|19.6||0.5066|TWO_SIDED|95.0|-3.12|16.52|||Wilcoxon (Mann-Whitney)|||||16.52|-3.12|0.5066
72407069|NCT00494494|144322857|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.05|STANDARD_DEVIATION|0.21||0.5099|TWO_SIDED|95.0|-0.13|0.227|||Wilcoxon (Mann-Whitney)|||||0.227|-0.13|0.5099
72407070|NCT00494494|144322858|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.03|STANDARD_DEVIATION|5.64||0.5005|TWO_SIDED|95.0|-1.49|3.55|||Wilcoxon (Mann-Whitney)|||||3.55|-1.49|0.5005
72526470|NCT02202161|144583522|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.69|||||TWO_SIDED|95.0|0.59|0.8|||||Comparison for Day 14, LDL cholesterol|An estimation approach was used.||0.80|0.59|
72526471|NCT02202161|144583522|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.94|||||TWO_SIDED|95.0|0.81|1.09|||||Comparison for Day 14, LDL cholesterol|An estimation approach was used.||1.09|0.81|
72526472|NCT02202161|144583522|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.99|||||TWO_SIDED|95.0|0.8|1.22|||||Comparison for Day 14, non-HDL cholesterol|An estimation approach was used.||1.22|0.80|
72526473|NCT02202161|144583522|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.77|||||TWO_SIDED|95.0|0.64|0.93|||||Comparison for Day 14, non-HDL cholesterol|An estimation approach was used.||0.93|0.64|
72526474|NCT02202161|144583522|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.77|||||TWO_SIDED|95.0|0.67|0.9|||||Comparison for Day 14, non-HDL cholesterol|An estimation approach was used.||0.90|0.67|
72526475|NCT02202161|144583522|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.65|||||TWO_SIDED|95.0|0.55|0.75|||||Comparison for Day 14, non-HDL cholesterol|An estimation approach was used.||0.75|0.55|
72526476|NCT02202161|144583522|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.7|||||TWO_SIDED|95.0|0.6|0.81|||||Comparison for Day 14, non-HDL cholesterol|An estimation approach was used.||0.81|0.60|
72526477|NCT02202161|144583522|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.91|||||TWO_SIDED|95.0|0.8|1.04|||||Comparison for Day 14, non-HDL cholesterol|An estimation approach was used.||1.04|0.80|
72526478|NCT02202161|144583522|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|1.42|||||TWO_SIDED|95.0|1.01|2.0|||||Comparison for Day 14, triglycerides|An estimation approach was used.||2.00|1.01|
72526479|NCT02202161|144583522|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|1.28|||||TWO_SIDED|95.0|0.94|1.75|||||Comparison for Day 14, triglycerides|An estimation approach was used.||1.75|0.94|
72526480|NCT02202161|144583522|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|1.24|||||TWO_SIDED|95.0|0.98|1.58|||||Comparison for Day 14, triglycerides|An estimation approach was used.||1.58|0.98|
72526481|NCT02202161|144583522|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|1.22|||||TWO_SIDED|95.0|0.95|1.56|||||Comparison for Day 14, triglycerides|An estimation approach was used.||1.56|0.95|
72526482|NCT02202161|144583522|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|1.23|||||TWO_SIDED|95.0|0.96|1.57|||||Comparison for Day 14, triglycerides|An estimation approach was used.||1.57|0.96|
72526483|NCT02202161|144583522|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.89|||||TWO_SIDED|95.0|0.72|1.11|||||Comparison for Day 14, triglycerides|An estimation approach was used.||1.11|0.72|
72526484|NCT02202161|144583523|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.98|||||TWO_SIDED|95.0|0.87|1.11|||||Comparison for Day 7, apolipoprotein B|An estimation approach was used.||1.11|0.87|
72526485|NCT02202161|144583523|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.79|||||TWO_SIDED|95.0|0.71|0.89|||||Comparison for Day 7, apolipoprotein B|An estimation approach was used.||0.89|0.71|
72526486|NCT02202161|144583523|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.82|||||TWO_SIDED|95.0|0.74|0.9|||||Comparison for Day 7, apolipoprotein B|An estimation approach was used.||0.90|0.74|
72526487|NCT02202161|144583523|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.7|||||TWO_SIDED|95.0|0.63|0.77|||||Comparison for Day 7, apolipoprotein B|An estimation approach was used.||0.77|0.63|
72526488|NCT02202161|144583523|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.77|||||TWO_SIDED|95.0|0.7|0.85|||||Comparison for Day 7, apolipoprotein B|An estimation approach was used.||0.85|0.70|
72526489|NCT02202161|144583523|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.97|||||TWO_SIDED|95.0|0.89|1.06|||||Comparison for Day 7, apolipoprotein B|An estimation approach was used.||1.06|0.89|
72526490|NCT02202161|144583523|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.91|||||TWO_SIDED|95.0|0.77|1.07|||||Comparison for Day 14, apolipoprotein B|An estimation approach was used.||1.07|0.77|
72526491|NCT02202161|144583523|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.81|||||TWO_SIDED|95.0|0.68|0.95|||||Comparison for Day 14, apolipoprotein B|An estimation approach was used.||0.95|0.68|
72407071|NCT02477020|144322862|SUPERIORITY_OR_OTHER||Least square mean difference|-5.46|STANDARD_ERROR_OF_MEAN|3.442||0.115|TWO_SIDED|95.0|-12.26|1.35||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using MMRM|MMRM||TAK-063 - Placebo. Baseline Positive and Negative Symptom Scale (PANSS) total score was used as covariate, pooled center, week and treatment as fixed factors, treatment-by-week interaction and Baseline PANSS total score-by-week interaction.|||1.35|-12.26|0.115
72407072|NCT02477020|144322863|SUPERIORITY_OR_OTHER||Least square mean difference|-0.79|STANDARD_ERROR_OF_MEAN|1.508||0.602|TWO_SIDED|95.0|-3.77|2.19||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using MMRM.|MMRM||TAK-063 - Placebo. Baseline PANSS total score was used as covariate, pooled center, week and treatment as fixed factors, treatment-by-week interaction and Baseline PANSS total score-by-week interaction.|Change at Week 1||2.19|-3.77|0.602
72526492|NCT02202161|144583523|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.8|||||TWO_SIDED|95.0|0.7|0.91|||||Comparison for Day 14, apolipoprotein B|An estimation approach was used.||0.91|0.70|
72526493|NCT02202161|144583523|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.67|||||TWO_SIDED|95.0|0.58|0.77|||||Comparison for Day 14, apolipoprotein B|An estimation approach was used.||0.77|0.58|
72407073|NCT02477020|144322863|SUPERIORITY_OR_OTHER||Least square mean difference|-2.22|STANDARD_ERROR_OF_MEAN|2.229||0.322|TWO_SIDED|95.0|-6.62|2.19||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. Baseline PANSS total score was used as covariate, pooled center, week and treatment as fixed factors, treatment-by-week interaction and Baseline PANSS total score-by-week interaction.|Change at Week 2||2.19|-6.62|0.322
72407074|NCT02477020|144322863|SUPERIORITY_OR_OTHER||Least square mean difference|-3.46|STANDARD_ERROR_OF_MEAN|2.813||0.221|TWO_SIDED|95.0|-9.02|2.1||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. Baseline PANSS total score was used as covariate, pooled center, week and treatment as fixed factors, treatment-by-week interaction and Baseline PANSS total score-by-week interaction.|Change at Week 3||2.10|-9.02|0.221
72526494|NCT02202161|144583523|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.73|||||TWO_SIDED|95.0|0.64|0.83|||||Comparison for Day 14, apolipoprotein B|An estimation approach was used.||0.83|0.64|
72526495|NCT02202161|144583523|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.9|||||TWO_SIDED|95.0|0.8|1.02|||||Comparison for Day 14, apolipoprotein B|An estimation approach was used.||1.02|0.80|
72526496|NCT01930487|144583530|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.037|STANDARD_ERROR_OF_MEAN|0.011||0.0016|TWO_SIDED||||||paired t-test, 2-sided||dietary supplement with antioxidants - placebo|||||0.0016
72526497|NCT01930487|144583531|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.025|STANDARD_ERROR_OF_MEAN|0.011||0.0249|TWO_SIDED||||||paired t-test, 2-sided||dietary supplement with antioxidants - placebo|||||0.0249
72526498|NCT01930487|144583532|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.1|STANDARD_ERROR_OF_MEAN|1.3||0.9147|TWO_SIDED||||||paired t-test, 2-sided||dietary supplement with antioxidants - placebo|||||0.9147
72526499|NCT01930487|144583533|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.67|STANDARD_ERROR_OF_MEAN|0.59||0.007|TWO_SIDED||||||paired t-test, 2-sided||dietary supplement with antioxidants - placebo|||||0.0070
72526500|NCT01930487|144583534|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.97|STANDARD_ERROR_OF_MEAN|0.21|<|0.0001|TWO_SIDED||||||paired t-test, 2-sidede||dietary supplement with antioxidants - placebo|||||<0.0001
72526501|NCT01930487|144583535|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.46|STANDARD_ERROR_OF_MEAN|0.23||0.0476|TWO_SIDED||||||paired t-test, 2-sided||dietary supplement with antioxidants - placebo|||||0.0476
72526502|NCT01930487|144583536|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.45|STANDARD_ERROR_OF_MEAN|0.21||0.0352|TWO_SIDED||||||paired t-test, 2-sided||dietary supplement with antioxidants - placebo|||||0.0352
72526503|NCT01930487|144583537|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.51|STANDARD_ERROR_OF_MEAN|0.21||0.0208|TWO_SIDED||||||paired t-test, 2-sided||dietary supplement with antioxidants - placebo|||||0.0208
72526504|NCT01930487|144583538|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.38|STANDARD_ERROR_OF_MEAN|0.07|<|0.0001|TWO_SIDED||||||paired t-test, 2-sided||dietary supplement with antioxidants - placebo|||||<0.0001
72526505|NCT01930487|144583539|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.24|STANDARD_ERROR_OF_MEAN|0.07||0.0024|TWO_SIDED||||||paired t-test, 2-sided||dietary supplement with antioxidants - placebo|||||0.0024
72526506|NCT01930487|144583540|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.21|STANDARD_ERROR_OF_MEAN|0.07||0.0081|TWO_SIDED||||||paired t-test, 2-sided||dietary supplement with antioxidants - placebo|||||0.0081
72571333|NCT03107026|144671297|SUPERIORITY||Mean Difference (Final Values)|-0.55|STANDARD_ERROR_OF_MEAN|0.192||0.0045|TWO_SIDED|95.0|-0.93|-0.17|||Mixed Models Analysis|||||-0.17|-0.93|0.0045
72526507|NCT01930487|144583541|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.002|STANDARD_ERROR_OF_MEAN|0.008||0.8191|TWO_SIDED||||||paired t-test, 2-sided||dietary supplement with antioxidants - placebo|||||0.8191
72526508|NCT01930487|144583542|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.018|STANDARD_ERROR_OF_MEAN|0.009||0.0482|TWO_SIDED||||||paired t-test, 2-sided||dietary supplement with antioxidants - placebo|||||0.0482
72526509|NCT01930487|144583543|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.019|STANDARD_ERROR_OF_MEAN|0.023||0.023|TWO_SIDED||||||paired t-test, 2-sided||dietary supplement with antioxidants - placebo|||||0.0230
72526510|NCT01930487|144583544|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.013|STANDARD_ERROR_OF_MEAN|0.008||0.1202|TWO_SIDED||||||paired t-test, 2-sided||dietary supplement with antioxidants - placebo|||||0.1202
72526511|NCT01930487|144583545|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.55|STANDARD_ERROR_OF_MEAN|0.83||0.0063|TWO_SIDED||||||paired t-test, 2-sided||dietary supplement with antioxidants - placebo|||||0.0063
72526512|NCT01930487|144583546|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.8|STANDARD_ERROR_OF_MEAN|0.8||0.3347|TWO_SIDED||||||paired t-test, 2-sided||dietary supplement with antioxidants - placebo|||||0.3347
72571334|NCT03107026|144671298|SUPERIORITY||Mean Difference (Final Values)|-0.36|STANDARD_ERROR_OF_MEAN|0.162||0.0256|TWO_SIDED|95.0|-0.68|-0.04|||Mixed Models Analysis|||||-0.04|-0.68|0.0256
72407075|NCT02477020|144322863|SUPERIORITY_OR_OTHER||Least square mean difference|-2.11|STANDARD_ERROR_OF_MEAN|3.147||0.504|TWO_SIDED|95.0|-8.33|4.11||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. Baseline PANSS total score was used as covariate, pooled center, week and treatment as fixed factors, treatment-by-week interaction and Baseline PANSS total score-by-week interaction.|Change at Week 4||4.11|-8.33|0.504
72407076|NCT02477020|144322863|SUPERIORITY_OR_OTHER||Least square mean difference|-3.91|STANDARD_ERROR_OF_MEAN|3.231||0.229|TWO_SIDED|95.0|-10.3|2.48||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. Baseline PANSS total score was used as covariate, pooled center, week and treatment as fixed factors, treatment-by-week interaction and Baseline PANSS total score-by-week interaction.|Change at Week 5||2.48|-10.30|0.229
72407077|NCT02477020|144322864|SUPERIORITY_OR_OTHER||Least square mean difference|-0.73|STANDARD_ERROR_OF_MEAN|0.562||0.195|TWO_SIDED|95.0|-1.84|0.38||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. PANSS Marder five-factor score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction, and Baseline PANSS Marder five-factor score-by-week interaction.|Positive symptoms, Change at Week 1||0.38|-1.84|0.195
72407078|NCT02477020|144322864|SUPERIORITY_OR_OTHER||Least square mean difference|-1.19|STANDARD_ERROR_OF_MEAN|0.786||0.132|TWO_SIDED|95.0|-2.74|0.36||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. PANSS Marder five-factor score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction, and Baseline PANSS Marder five-factor score-by-week interaction.|Positive symptoms, Change at Week 2||0.36|-2.74|0.132
72407079|NCT02477020|144322864|SUPERIORITY_OR_OTHER||Least square mean difference|-1.94|STANDARD_ERROR_OF_MEAN|0.959||0.045|TWO_SIDED|95.0|-3.84|-0.05||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. PANSS Marder five-factor score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction, and Baseline PANSS Marder five-factor score-by-week interaction.|Positive symptoms, Change at Week 3||-0.05|-3.84|0.045
72407080|NCT02477020|144322864|SUPERIORITY_OR_OTHER||Least square mean difference|-1.54|STANDARD_ERROR_OF_MEAN|1.025||0.135|TWO_SIDED|95.0|-3.56|0.49||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. PANSS Marder five-factor score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction, and Baseline PANSS Marder five-factor score-by-week interaction.|Positive symptoms, Change at Week 4||0.49|-3.56|0.135
72407081|NCT02477020|144322864|SUPERIORITY_OR_OTHER||Least square mean difference|-2.01|STANDARD_ERROR_OF_MEAN|1.09||0.067|TWO_SIDED|95.0|-4.17|0.14||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. PANSS Marder five-factor score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction, and Baseline PANSS Marder five-factor score-by-week interaction.|Positive symptoms, Change at Week 5||0.14|-4.17|0.067
72407082|NCT02477020|144322864|SUPERIORITY_OR_OTHER||Least square mean difference|-1.9|STANDARD_ERROR_OF_MEAN|1.119||0.092|TWO_SIDED|95.0|-4.11|0.31||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. PANSS Marder five-factor score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction, and Baseline PANSS Marder five-factor score-by-week interaction.|Positive symptoms, Change at Week 6||0.31|-4.11|0.092
72407083|NCT02477020|144322864|SUPERIORITY_OR_OTHER||Least square mean difference|0.34|STANDARD_ERROR_OF_MEAN|0.566||0.548|TWO_SIDED|95.0|-0.78|1.46||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. PANSS Marder five-factor score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction, and Baseline PANSS Marder five-factor score-by-week interaction.|Negative symptoms, Change at Week 1||1.46|-0.78|0.548
72407084|NCT02477020|144322864|SUPERIORITY_OR_OTHER||Least square mean difference|-0.61|STANDARD_ERROR_OF_MEAN|0.756||0.42|TWO_SIDED|95.0|-2.11|0.88||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. PANSS Marder five-factor score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction, and Baseline PANSS Marder five-factor score-by-week interaction.|Negative symptoms, Change at Week 2||0.88|-2.11|0.420
72407085|NCT02477020|144322864|SUPERIORITY_OR_OTHER||Least square mean difference|0.15|STANDARD_ERROR_OF_MEAN|0.818||0.857|TWO_SIDED|95.0|-1.47|1.76||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. PANSS Marder five-factor score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction, and Baseline PANSS Marder five-factor score-by-week interaction.|Negative symptoms, Change at Week 3||1.76|-1.47|0.857
72407086|NCT02477020|144322864|SUPERIORITY_OR_OTHER||Least square mean difference|-0.59|STANDARD_ERROR_OF_MEAN|0.936||0.527|TWO_SIDED|95.0|-2.44|1.26||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. PANSS Marder five-factor score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction, and Baseline PANSS Marder five-factor score-by-week interaction.|Negative symptoms, Change at Week 4||1.26|-2.44|0.527
72526513|NCT01930487|144583547|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.02|STANDARD_ERROR_OF_MEAN|0.35||0.0094|TWO_SIDED||||||paired t-test, 2-sided||dietary supplement with antioxidants - placebo|||||0.0094
72526514|NCT01930487|144583548|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.92|STANDARD_ERROR_OF_MEAN|0.24||0.0009|TWO_SIDED||||||paired t-test, 2-sided||dietary supplement with antioxidants - placebo|||||0.0009
72526515|NCT01930487|144583549|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.02|STANDARD_ERROR_OF_MEAN|0.34||0.0067|TWO_SIDED||||||paired t-test, 2-sided||dietary supplement with antioxidants - placebo|||||0.0067
72526516|NCT01930487|144583550|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1|STANDARD_ERROR_OF_MEAN|0.25||0.6938|TWO_SIDED||||||paired t-test, 2-sided||dietary supplement with antioxidants - placebo|||||0.6938
72526517|NCT01930487|144583551|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.56|STANDARD_ERROR_OF_MEAN|0.3||0.0805|TWO_SIDED||||||paired t-test, 2-sided||dietary supplement with antioxidants - placebo|||||0.0805
72407087|NCT02477020|144322864|SUPERIORITY_OR_OTHER||Least square mean difference|-0.15|STANDARD_ERROR_OF_MEAN|0.94||0.875|TWO_SIDED|95.0|-2.01|1.71||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. PANSS Marder five-factor score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction, and Baseline PANSS Marder five-factor score-by-week interaction.|Negative symptoms, Change at Week 5||1.71|-2.01|0.875
72407088|NCT02477020|144322864|SUPERIORITY_OR_OTHER||Least square mean difference|-0.73|STANDARD_ERROR_OF_MEAN|0.94||0.441|TWO_SIDED|95.0|-2.58|1.13||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. PANSS Marder five-factor score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction, and Baseline PANSS Marder five-factor score-by-week interaction.|Negative symptoms, Change at Week 6||1.13|-2.58|0.441
72407089|NCT02477020|144322864|SUPERIORITY_OR_OTHER||Least square mean difference|-0.37|STANDARD_ERROR_OF_MEAN|0.406||0.362|TWO_SIDED|95.0|-1.17|0.43||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. PANSS Marder five-factor score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction, and Baseline PANSS Marder five-factor score-by-week interaction.|Disorganized thoughts, Change at Week 1||0.43|-1.17|0.362
72407090|NCT02477020|144322864|SUPERIORITY_OR_OTHER||Least square mean difference|-0.21|STANDARD_ERROR_OF_MEAN|0.53||0.687|TWO_SIDED|95.0|-1.26|0.83||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. PANSS Marder five-factor score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction, and Baseline PANSS Marder five-factor score-by-week interaction.|Disorganized thoughts, Change at Week 2||0.83|-1.26|0.687
72407091|NCT02477020|144322864|SUPERIORITY_OR_OTHER||Least square mean difference|-0.46|STANDARD_ERROR_OF_MEAN|0.618||0.458|TWO_SIDED|95.0|-1.68|0.76||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. PANSS Marder five-factor score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction, and Baseline PANSS Marder five-factor score-by-week interaction.|Disorganized thoughts, Change at Week 3||0.76|-1.68|0.458
72526518|NCT01930487|144583552|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.35|STANDARD_ERROR_OF_MEAN|0.29||0.2451|TWO_SIDED||||||paired t-test, 2-sided||dietary supplement with antioxidants - placebo|||||0.2451
72526519|NCT01930487|144583553|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.78|STANDARD_ERROR_OF_MEAN|0.34||0.0323|TWO_SIDED||||||paired t-test, 2-sided||dietary supplement with antioxidants - placebo|||||0.0323
72526520|NCT01930487|144583554|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.25|STANDARD_ERROR_OF_MEAN|0.26||0.344|TWO_SIDED||||||paired t-test, 2-sided||dietary supplement with antioxidants - placebo|||||0.3440
72526521|NCT01930487|144583555|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.37|STANDARD_ERROR_OF_MEAN|0.13||0.0119|TWO_SIDED||||||paired t-test, 2-sided||dietary supplement with antioxidants - placebo|||||0.0119
72407092|NCT02477020|144322864|SUPERIORITY_OR_OTHER||Least square mean difference|0.01|STANDARD_ERROR_OF_MEAN|0.704||0.991|TWO_SIDED|95.0|-1.38|1.4||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. PANSS Marder five-factor score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction, and Baseline PANSS Marder five-factor score-by-week interaction.|Disorganized thoughts, Change at Week 4||1.40|-1.38|0.991
72526522|NCT01930487|144583556|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.4|STANDARD_ERROR_OF_MEAN|0.07|<|0.0001|TWO_SIDED||||||paired t-test, 2-sided||dietary supplement with antioxidants - placebo|||||<0.0001
72526523|NCT01930487|144583557|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.32|STANDARD_ERROR_OF_MEAN|0.12||0.0137|TWO_SIDED||||||paired t-test, 2-sided||dietary supplement with antioxidants - placebo|||||0.0137
72526524|NCT01930487|144583558|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.16|STANDARD_ERROR_OF_MEAN|0.09||0.0866|TWO_SIDED||||||paired t-test, 2-sided||dietary supplement with antioxidants - placebo|||||0.0866
72526525|NCT01930487|144583559|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.23|STANDARD_ERROR_OF_MEAN|0.12||0.0656|TWO_SIDED||||||paired t-test, 2-sided||dietary supplement with antioxidants - placebo|||||0.0656
72526526|NCT01930487|144583560|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.19|STANDARD_ERROR_OF_MEAN|0.09||0.0626|TWO_SIDED||||||paired t-test, 2-sided||dietary supplement with antioxidants - placebo|||||0.0626
72526527|NCT01930487|144583561|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.003|STANDARD_ERROR_OF_MEAN|0.013||0.81|TWO_SIDED||||||paired t-test, 2-sided||dietary supplement with antioxidants - placebo|||||0.8100
72526528|NCT01930487|144583562|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.001|STANDARD_ERROR_OF_MEAN|0.01||0.9556|TWO_SIDED||||||paired t-test, 2-sided||dietary supplement with antioxidants - placebo|||||0.9556
72526529|NCT01930487|144583563|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.015|STANDARD_ERROR_OF_MEAN|0.015||0.3414|TWO_SIDED||||||paired t-test, 2-sided||dietary supplement with antioxidants - placebo|||||0.3414
72526530|NCT01930487|144583564|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.021|STANDARD_ERROR_OF_MEAN|0.009||0.033|TWO_SIDED||||||paired t-test, 2-sided||dietary supplement with antioxidants - placebo|||||0.0330
72526531|NCT01930487|144583565|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.01|STANDARD_ERROR_OF_MEAN|0.01||0.3326|TWO_SIDED||||||paired t-test, 2-sided||dietary supplement with antioxidants - placebo|||||0.3326
72571335|NCT03107026|144671298|SUPERIORITY||Median Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|0.166||0.0025|TWO_SIDED|95.0|-0.83|-0.18|||Mixed Models Analysis|||||-0.18|-0.83|0.0025
72571336|NCT03107026|144671299|SUPERIORITY||Odds Ratio (OR)|1.16||||0.5342|TWO_SIDED|95.0|0.726|1.854|||Regression, Logistic|||||1.854|0.726|0.5342
72571337|NCT03107026|144671299|SUPERIORITY||Odds Ratio (OR)|1.179||||0.4905|TWO_SIDED|95.0|0.738|1.882|||Regression, Logistic|||||1.882|0.738|0.4905
72571338|NCT03107026|144671300|SUPERIORITY||Mean Difference (Final Values)|-2.3|STANDARD_ERROR_OF_MEAN|0.946||0.0154|TWO_SIDED|95.0|-4.16|-0.44|||Mixed Models Analysis|||||-0.44|-4.16|0.0154
72571339|NCT03107026|144671300|SUPERIORITY||Mean Difference (Net)|-3.4|STANDARD_ERROR_OF_MEAN|0.969||0.0005|TWO_SIDED|95.0|-5.31|-1.5|||Mixed Models Analysis|||||-1.50|-5.31|0.0005
72571340|NCT04709835|144671324|SUPERIORITY||Difference in Adjusted Means|-0.11|STANDARD_ERROR_OF_MEAN|0.292||0.7144|TWO_SIDED|80.0|-0.49|0.27|||ANCOVA||A difference in adjusted means of \<0 favors RO7496998 (AT-527).|Day 3||0.27|-0.49|0.7144
72407093|NCT02477020|144322864|SUPERIORITY_OR_OTHER||Least square mean difference|-0.73|STANDARD_ERROR_OF_MEAN|0.782||0.354|TWO_SIDED|95.0|-2.27|0.82||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. PANSS Marder five-factor score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction, and Baseline PANSS Marder five-factor score-by-week interaction.|Disorganized thoughts, Change at Week 5||0.82|-2.27|0.354
72407094|NCT02477020|144322864|SUPERIORITY_OR_OTHER||Least square mean difference|-1.26|STANDARD_ERROR_OF_MEAN|0.804||0.119|TWO_SIDED|95.0|-2.85|0.33||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. PANSS Marder five-factor score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction, and Baseline PANSS Marder five-factor score-by-week interaction.|Disorganized thoughts, Change at Week 6||0.33|-2.85|0.119
72407095|NCT02477020|144322864|SUPERIORITY_OR_OTHER||Least square mean difference|-0.32|STANDARD_ERROR_OF_MEAN|0.469||0.493|TWO_SIDED|95.0|-1.25|0.6||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. PANSS Marder five-factor score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction, and Baseline PANSS Marder five-factor score-by-week interaction.|Hostility, Change at Week 1||0.60|-1.25|0.493
72407096|NCT02477020|144322864|SUPERIORITY_OR_OTHER||Least square mean difference|0.03|STANDARD_ERROR_OF_MEAN|0.504||0.949|TWO_SIDED|95.0|-0.96|1.03||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. PANSS Marder five-factor score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction, and Baseline PANSS Marder five-factor score-by-week interaction.|Hostility, Change at Week 2||1.03|-0.96|0.949
72407097|NCT02477020|144322864|SUPERIORITY_OR_OTHER||Least square mean difference|-0.87|STANDARD_ERROR_OF_MEAN|0.604||0.153|TWO_SIDED|95.0|-2.06|0.33||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. PANSS Marder five-factor score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction, and Baseline PANSS Marder five-factor score-by-week interaction.|Hostility, Change at Week 3||0.33|-2.06|0.153
72407098|NCT02477020|144322864|SUPERIORITY_OR_OTHER||Least square mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.681||0.994|TWO_SIDED|95.0|-1.34|1.35||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. PANSS Marder five-factor score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction, and Baseline PANSS Marder five-factor score-by-week interaction.|Hostility, Change at Week 4||1.35|-1.34|0.994
72407099|NCT02477020|144322864|SUPERIORITY_OR_OTHER||Least square mean difference|-0.62|STANDARD_ERROR_OF_MEAN|0.679||0.365|TWO_SIDED|95.0|-1.96|0.73||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. PANSS Marder five-factor score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction, and Baseline PANSS Marder five-factor score-by-week interaction.|Hostility, Change at Week 5||0.73|-1.96|0.365
72407100|NCT02477020|144322864|SUPERIORITY_OR_OTHER||Least square mean difference|-1.12|STANDARD_ERROR_OF_MEAN|0.653||0.088|TWO_SIDED|95.0|-2.41|0.17||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. PANSS Marder five-factor score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction, and Baseline PANSS Marder five-factor score-by-week interaction.|Hostility, Change at Week 6||0.17|-2.41|0.088
72407101|NCT02477020|144322864|SUPERIORITY_OR_OTHER||Least square mean difference|0.25|STANDARD_ERROR_OF_MEAN|0.397||0.535|TWO_SIDED|95.0|-0.54|1.03||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. PANSS Marder five-factor score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction, and Baseline PANSS Marder five-factor score-by-week interaction.|Anxiety, Change at Week 1||1.03|-0.54|0.535
72526532|NCT01930487|144583566|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.027|STANDARD_ERROR_OF_MEAN|0.012||0.0348|TWO_SIDED||||||paired t-test, 2-sided||dietary supplement with antioxidants - placebo|||||0.0348
72526533|NCT01930487|144583567|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.016|STANDARD_ERROR_OF_MEAN|0.012||0.2089|TWO_SIDED||||||paired t-test, 2-sided||dietary supplement with antioxidants - placebo|||||0.2089
72526534|NCT01930487|144583568|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.01|STANDARD_ERROR_OF_MEAN|0.012||0.3738|TWO_SIDED||||||paired t-test, 2-sided||dietary supplement with antioxidants - placebo|||||0.3738
72526535|NCT01930487|144583569|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.3|STANDARD_ERROR_OF_MEAN|1.7||0.447|TWO_SIDED||||||paired t-test, 2-sided||dietary supplement with antioxidants - placebo|||||0.4470
72526536|NCT01930487|144583570|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.0|STANDARD_ERROR_OF_MEAN|2.1||0.6382|TWO_SIDED||||||paired t-test, 2-sided||dietary supplement with antioxidants - placebo|||||0.6382
72526537|NCT01930487|144583571|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.043|STANDARD_ERROR_OF_MEAN|0.012||0.0026|TWO_SIDED||||||paird t-test, 2-sided||dietary supplement with antioxidants - placebo|||||0.0026
72526538|NCT01930487|144583572|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.03|STANDARD_ERROR_OF_MEAN|0.018||0.1045|TWO_SIDED||||||paired t-test, 2-sided||dietary supplement with antioxidants - placebo|||||0.1045
72526539|NCT01930487|144583573|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.005|STANDARD_ERROR_OF_MEAN|0.013||0.6941|TWO_SIDED||||||paired t-test||dietary supplement with antioxidants - placebo|||||0.6941
72526540|NCT01930487|144583574|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.046|STANDARD_ERROR_OF_MEAN|0.017||0.0138|TWO_SIDED||||||paired t-test, 2-sided||dietary supplement with antioxidants - placebo|||||0.0138
72526541|NCT02711553|144583575|SUPERIORITY||Hazard Ratio (HR)|1.123||||0.4821|TWO_SIDED|80.0|0.904|1.395||p-value is 2-sided.|Log Rank|Stratified by geographical region, pathological diagnosis, metastatic disease.|Stratified by geographical region, pathological diagnosis, metastatic disease.|||1.395|0.904|0.4821
72526542|NCT02711553|144583575|SUPERIORITY||Hazard Ratio (HR)|0.92||||0.6417|TWO_SIDED|80.0|0.734|1.153||p-value is 2-sided.|Log Rank|Stratified by geographical region, pathological diagnosis, metastatic disease.|Stratified by geographical region, pathological diagnosis, metastatic disease.|||1.153|0.734|0.6417
72407102|NCT02477020|144322864|SUPERIORITY_OR_OTHER||Least square mean difference|-0.41|STANDARD_ERROR_OF_MEAN|0.502||0.412|TWO_SIDED|95.0|-1.4|0.58||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. PANSS Marder five-factor score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction, and Baseline PANSS Marder five-factor score-by-week interaction.|Anxiety, Change at Week 2||0.58|-1.40|0.412
72407103|NCT02477020|144322864|SUPERIORITY_OR_OTHER||Least square mean difference|-0.49|STANDARD_ERROR_OF_MEAN|0.522||0.354|TWO_SIDED|95.0|-1.52|0.55||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. PANSS Marder five-factor score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction, and Baseline PANSS Marder five-factor score-by-week interaction.|Anxiety, Change at Week 3||0.55|-1.52|0.354
72407104|NCT02477020|144322864|SUPERIORITY_OR_OTHER||Least square mean difference|-0.32|STANDARD_ERROR_OF_MEAN|0.59||0.589|TWO_SIDED|95.0|-1.49|0.85||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. PANSS Marder five-factor score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction, and Baseline PANSS Marder five-factor score-by-week interaction.|Anxiety, Change at Week 4||0.85|-1.49|0.589
72407105|NCT02477020|144322864|SUPERIORITY_OR_OTHER||Least square mean difference|-0.52|STANDARD_ERROR_OF_MEAN|0.569||0.36|TWO_SIDED|95.0|-1.65|0.6||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. PANSS Marder five-factor score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction, and Baseline PANSS Marder five-factor score-by-week interaction.|Anxiety, Change at Week 5||0.60|-1.65|0.360
72407106|NCT02477020|144322864|SUPERIORITY_OR_OTHER||Least square mean difference|-0.68|STANDARD_ERROR_OF_MEAN|0.635||0.288|TWO_SIDED|95.0|-1.93|0.58||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. PANSS Marder five-factor score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction, and Baseline PANSS Marder five-factor score-by-week interaction.|Anxiety, Change at Week 6||0.58|-1.93|0.288
72407107|NCT02477020|144322865|SUPERIORITY_OR_OTHER||Least square mean difference|-0.7|STANDARD_ERROR_OF_MEAN|0.59||0.238|TWO_SIDED|95.0|-1.87|0.47||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. PANSS subscale score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction and Baseline PANSS subscale score-by-week interaction.|PANSS Positive Score, Change at Week 1||0.47|-1.87|0.238
72526543|NCT02711553|144583576|SUPERIORITY||Hazard Ratio (HR)|1.336||||0.087|TWO_SIDED|95.0|0.959|1.862|||Log Rank|Stratified by geographical region, pathological diagnosis, metastatic disease.|Stratified by geographical region, pathological diagnosis, metastatic disease.|||1.862|0.959|0.0870
72526544|NCT02711553|144583576|SUPERIORITY||Hazard Ratio (HR)|0.948||||0.7599|TWO_SIDED|95.0|0.669|1.342|||Log Rank|Stratified by geographical region, pathological diagnosis, metastatic disease.|Stratified by geographical region, pathological diagnosis, metastatic disease.|||1.342|0.669|0.7599
72526545|NCT02711553|144583577|SUPERIORITY||Odds Ratio (OR)|1.0||||0.878|TWO_SIDED|95.0|0.6|1.9|||Exact Cochran-Mantel-Haenszel|Stratified by randomization strata Geographical Region, Pathological Diagnosis, Metastatic Disease.|Stratified by randomization strata Geographical Region, Pathological Diagnosis, Metastatic Disease.|||1.9|0.6|0.878
72526546|NCT02711553|144583577|SUPERIORITY||Odds Ratio (OR)|0.5||||0.023|TWO_SIDED|95.0|0.2|0.9|||Exact Cochran-Mantel-Haenszel|Stratified by randomization strata Geographical Region, Pathological Diagnosis, Metastatic Disease.|Stratified by randomization strata Geographical Region, Pathological Diagnosis, Metastatic Disease.|||0.9|0.2|0.023
72526547|NCT02711553|144583578|SUPERIORITY||Odds Ratio (OR)|1.2||||0.68|TWO_SIDED|95.0|0.6|2.4|||Exact Cochran-Mantel-Haenszel|Stratified by randomization strata Geographical Region, Pathological Diagnosis, Metastatic Disease.|Stratified by randomization strata Geographical Region, Pathological Diagnosis, Metastatic Disease.|||2.4|0.6|0.680
72407108|NCT02477020|144322865|SUPERIORITY_OR_OTHER||Least square mean difference|-0.72|STANDARD_ERROR_OF_MEAN|0.784||0.359|TWO_SIDED|95.0|-2.27|0.83||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. PANSS subscale score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction and Baseline PANSS subscale score-by-week interaction.|PANSS Positive Score, Change at Week 2||0.83|-2.27|0.359
72407109|NCT02477020|144322865|SUPERIORITY_OR_OTHER||Least square mean difference|-1.48|STANDARD_ERROR_OF_MEAN|0.943||0.119|TWO_SIDED|95.0|-3.34|0.38||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. PANSS subscale score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction and Baseline PANSS subscale score-by-week interaction.|PANSS Positive Score, Change at Week 3||0.38|-3.34|0.119
72526548|NCT02711553|144583578|SUPERIORITY||Odds Ratio (OR)|1.3||||0.499|TWO_SIDED|95.0|0.6|2.6|||Exact Cochran-Mantel-Haenszel|Stratified by randomization strata Geographical Region, Pathological Diagnosis, Metastatic Disease.|Stratified by randomization strata Geographical Region, Pathological Diagnosis, Metastatic Disease.|||2.6|0.6|0.499
72526549|NCT02711553|144583582|SUPERIORITY||LS Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|0.6||0.069|TWO_SIDED|95.0|-2.28|0.09||p-values are from Type 3 sums of squares mixed model repeated measures (MMRM) Model.|MMRM Model|Least Squares (LS) Mean value was adjusted for treatment, visit, baseline, treatment\*visit and baseline\*visit.||PWB||0.09|-2.28|0.069
72526550|NCT02711553|144583582|SUPERIORITY||LS Mean Difference|-1.23|STANDARD_ERROR_OF_MEAN|0.6||0.042|TWO_SIDED|95.0|-2.42|-0.04||p-values are from type 3 sums of squares MMRM model.|MMRM Model|LS Mean value was adjusted for treatment, visit, baseline, treatment\*visit and baseline\*visit.||PWB||-0.04|-2.42|0.042
72526551|NCT02711553|144583582|SUPERIORITY||LS Mean Difference|-0.82|STANDARD_ERROR_OF_MEAN|0.51||0.112|TWO_SIDED|95.0|-1.83|0.19||p-values are from type 3 sums of squares MMRM model.|MMRM Model|LS Mean value was adjusted for treatment, visit, baseline, treatment\*visit and baseline\*visit.||SWB||0.19|-1.83|0.112
72526552|NCT02711553|144583582|SUPERIORITY||LS Mean Difference|-0.34|STANDARD_ERROR_OF_MEAN|0.51||0.505|TWO_SIDED|95.0|-1.35|0.67||p-values are from type 3 sums of squares MMRM model.|MMRM Model|LS Mean value was adjusted for treatment, visit, baseline, treatment\*visit and baseline\*visit.||SWB||0.67|-1.35|0.505
72526553|NCT02711553|144583582|SUPERIORITY||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.44||0.116|TWO_SIDED|95.0|-1.56|0.17||p-values are from type 3 sums of squares MMRM model.|MMRM Model|LS Mean value was adjusted for treatment, visit, baseline, treatment\*visit and baseline\*visit.||EWB||0.17|-1.56|0.116
72526554|NCT02711553|144583582|SUPERIORITY||LS Mean Difference|-0.29|STANDARD_ERROR_OF_MEAN|0.45||0.521|TWO_SIDED|95.0|-1.16|0.59||p-values are from type 3 sums of squares MMRM model.|MMRM Model|LS Mean value was adjusted for treatment, visit, baseline, treatment\*visit and baseline\*visit.||EWB||0.59|-1.16|0.521
72526555|NCT02711553|144583582|SUPERIORITY||LS Mean Difference|-1.66|STANDARD_ERROR_OF_MEAN|0.62||0.008|TWO_SIDED|95.0|-2.87|-0.44||p-values are from type 3 sums of squares MMRM model.|MMRM Model|LS Mean value was adjusted for treatment, visit, baseline, treatment\*visit and baseline\*visit.||FWB||-0.44|-2.87|0.008
72526556|NCT02711553|144583582|SUPERIORITY||LS Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.62||0.335|TWO_SIDED|95.0|-1.82|0.62||p-values are from type 3 sums of squares MMRM model.|MMRM Model|LS Mean value was adjusted for treatment, visit, baseline, treatment\*visit and baseline\*visit.||FWB||0.62|-1.82|0.335
72526557|NCT02711553|144583582|SUPERIORITY||LS Mean Difference|-2.93|STANDARD_ERROR_OF_MEAN|0.89||0.001|TWO_SIDED|95.0|-4.69|-1.18||p-values are from type 3 sums of squares MMRM model.|MMRM Model|LS Mean value was adjusted for treatment, visit, baseline, treatment\*visit and baseline\*visit.||HCS||-1.18|-4.69|0.001
72526558|NCT02711553|144583582|SUPERIORITY||LS Mean Difference|-1.64|STANDARD_ERROR_OF_MEAN|0.89||0.068|TWO_SIDED|95.0|-3.4|0.12||p-values are from type 3 sums of squares MMRM model.|MMRM Model|LS Mean value was adjusted for treatment, visit, baseline, treatment\*visit and baseline\*visit.||HCS||0.12|-3.40|0.068
72526559|NCT02711553|144583582|SUPERIORITY||LS Mean Difference|-1.02|STANDARD_ERROR_OF_MEAN|0.52||0.051|TWO_SIDED|95.0|-2.04|0.0||p-values are from type 3 sums of squares MMRM model.|MMRM Model|LS Mean value was adjusted for treatment, visit, baseline, treatment\*visit and baseline\*visit.||FACT-Hep||0.00|-2.04|0.051
72526560|NCT02711553|144583582|SUPERIORITY||LS Mean Difference|-0.65|STANDARD_ERROR_OF_MEAN|0.52||0.212|TWO_SIDED|95.0|-1.68|0.38||p-values are from type 3 sums of squares MMRM model.|MMRM Model|LS Mean value was adjusted for treatment, visit, baseline, treatment\*visit and baseline\*visit.||FACT-Hep||0.38|-1.68|0.212
72526561|NCT02711553|144583582|SUPERIORITY||LS Mean Difference|-5.67|STANDARD_ERROR_OF_MEAN|1.84||0.002|TWO_SIDED|95.0|-9.3|-2.04||p-values are from type 3 sums of squares MMRM model.|MMRM Model|LS Mean value was adjusted for treatment, visit, baseline, treatment\*visit and baseline\*visit.||TOI||-2.04|-9.30|0.002
72526562|NCT02711553|144583582|SUPERIORITY||LS Mean Difference|-3.42|STANDARD_ERROR_OF_MEAN|1.85||0.066|TWO_SIDED|95.0|-7.07|0.22||p-values are from type 3 sums of squares MMRM model.|MMRM Model|LS Mean value was adjusted for treatment, visit, baseline, treatment\*visit and baseline\*visit.||TOI||0.22|-7.07|0.066
72526563|NCT05559203|144583589|EQUIVALENCE|0.05 test of null hypothesis that there will be no significant change from baseline to post-intervention||||||0.752|||||||t-test, 2 sided|paired sample||Feasibility study so no power calculation. N = 18 with baseline and follow-up data.||||.752
72526564|NCT05559203|144583590|EQUIVALENCE|0.05 test of null hypothesis that there will be no significant change from baseline to post-intervention||||||0.197|||||||t-test, 2 sided|||Feasibility study so no power calculation. N = 18 with baseline and follow-up data.||||.197
72526565|NCT05559203|144583591|EQUIVALENCE|0.05 test of null hypothesis that there will be no significant change from baseline to post-intervention||||||0.562|||||||t-test, 2 sided|||||||.562
72571341|NCT04709835|144671324|SUPERIORITY||Difference in Adjusted Means|0.32|STANDARD_ERROR_OF_MEAN|0.327||0.3373|TWO_SIDED|80.0|-0.11|0.74|||ANCOVA||A difference in adjusted means of \<0 favors RO7496998 (AT-527).|Day 5||0.74|-0.11|0.3373
72526566|NCT05559203|144583592|EQUIVALENCE|0.05 test of null hypothesis that there will be no significant change from baseline to post-intervention||||||0.02|||||||t-test, 2 sided|||Anxiety subscale||||.020
72526567|NCT05559203|144583592|EQUIVALENCE|0.05 test of null hypothesis that there will be no significant change from baseline to post-intervention||||||0.002|||||||t-test, 2 sided|||Depression subscale||||.002
72526568|NCT05559203|144583593|EQUIVALENCE|0.05 test of null hypothesis that there will be no significant change from baseline to post-intervention||||||0.036|||||||t-test, 2 sided|||||||.036
72526569|NCT05559203|144583594|EQUIVALENCE|0.05 test of null hypothesis that there will be no significant change from baseline to post-intervention||||||0.042|||||||t-test, 2 sided|||||||.042
72526570|NCT05559203|144583595|EQUIVALENCE|0.05 test of null hypothesis that there will be no significant change from baseline to post-intervention|||||<|0.001|||||||t-test, 2 sided|||||||<.001
72526571|NCT05559203|144583596|EQUIVALENCE|0.05 test of null hypothesis that there will be no significant change from baseline to post-intervention||||||0.781|||||||t-test, 2 sided|||||||.781
72526572|NCT01012037|144583675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.74|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001||95.0|-0.97|-0.52|||ANCOVA|||Linagliptin 2.5mg bid versus Placebo||-0.52|-0.97|<0.0001
72526573|NCT01012037|144583675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001||95.0|-1.02|-0.58|||ANCOVA|||Linagliptin 5mg qd versus Placebo||-0.58|-1.02|<0.0001
72526574|NCT01012037|144583675|NON_INFERIORITY_OR_EQUIVALENCE|The pre-defined non-inferiority margin was +0.35|Mean Difference (Final Values)|0.06|STANDARD_ERROR_OF_MEAN|0.07||||95.0|-0.07|0.19|||ANCOVA|||Linagliptin 2.5mg bid versus Linagliptin 5mg qd||0.19|-0.07|
72526575|NCT01012037|144583676|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.66|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001||95.0|-0.83|-0.48|||Mixed Models Analysis|||Linagliptin 2.5mg bid versus Placebo||-0.48|-0.83|<0.0001
72526576|NCT01012037|144583676|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.66|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001||95.0|-0.84|-0.49|||Mixed Models Analysis|||Linagliptin 5mg qd versus Placebo||-0.49|-0.84|<0.0001
72571342|NCT04709835|144671324|SUPERIORITY||Difference in Adjusted Means|-0.25|STANDARD_ERROR_OF_MEAN|0.315||0.426|TWO_SIDED|80.0|-0.66|0.16|||ANCOVA||A difference in adjusted means of \<0 favors RO7496998 (AT-527).|Day 7||0.16|-0.66|0.4260
72571343|NCT04709835|144671325|SUPERIORITY||Hazard Ratio (HR)|0.96|||||TWO_SIDED|80.0|0.53|1.74|||||Hazard ratio (80% CI) was estimated with a Cox proportional hazards model (unadjusted).|||1.74|0.53|
72526577|NCT01012037|144583676|NON_INFERIORITY_OR_EQUIVALENCE|The pre-defined non-inferiority margin was +0.35|Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.05||||95.0|-0.1|0.1|||Mixed Models Analysis|||Linagliptin 2.5mg bid versus Linagliptin 5mg qd||0.10|-0.10|
72526578|NCT01012037|144583677|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.77|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001||95.0|-1.0|-0.54|||Mixed Models Analysis|||Linagliptin 2.5mg bid versus Placebo||-0.54|-1.00|<0.0001
72526579|NCT01012037|144583677|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.82|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001||95.0|-1.05|-0.59|||Mixed Models Analysis|||Linagliptin 5mg qd versus Placebo||-0.59|-1.05|<0.0001
72526580|NCT01012037|144583677|NON_INFERIORITY_OR_EQUIVALENCE|The pre-defined non-inferiority margin was +0.35|Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.07||||95.0|-0.08|0.18|||Mixed Models Analysis|||Linagliptin 2.5mg bid versus Linagliptin 5mg qd||0.18|-0.08|
72526581|NCT01012037|144583678|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.7|STANDARD_ERROR_OF_MEAN|4.6||0.0029||95.0|-22.7|-4.7|||ANCOVA|||Linagliptin 2.5mg bid versus Placebo||-4.7|-22.7|0.0029
72526582|NCT01012037|144583678|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.8|STANDARD_ERROR_OF_MEAN|4.6||0.0001||95.0|-26.7|-8.8|||ANCOVA|||Linagliptin 5 mg qd versus Placebo||-8.8|-26.7|0.0001
72526583|NCT01012037|144583678|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.1|STANDARD_ERROR_OF_MEAN|2.6||||95.0|-1.0|9.2|||ANCOVA||No non-inferiority margin was pre-defined for FPG|Linagliptin 2.5mg bid versus Linagliptin 5mg qd||9.2|-1.0|
72526584|NCT01012037|144583679|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.6|STANDARD_ERROR_OF_MEAN|4.4||0.0002||95.0|-25.3|-7.8|||Mixed Models Analysis|||Linagliptin 2.5mg bid versus Placebo||-7.8|-25.3|0.0002
72526585|NCT01012037|144583679|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-18.9|STANDARD_ERROR_OF_MEAN|4.4|<|0.0001||95.0|-27.6|-10.2|||Mixed Models Analysis|||Linagliptin 5mg qd versus Placebo||-10.2|-27.6|<0.0001
72526586|NCT01012037|144583679|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.3|STANDARD_ERROR_OF_MEAN|2.5||||95.0|-2.6|7.3|||Mixed Models Analysis||No non-inferiority margin was pre-defined for FPG|Linagliptin 2.5mg bid versus Linagliptin 5mg qd||7.3|-2.6|
72526587|NCT01012037|144583680|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.0|STANDARD_ERROR_OF_MEAN|5.4||0.0653||95.0|-20.6|0.6|||Mixed Models Analysis|||Linagliptin 2.5mg bid versus Placebo||0.6|-20.6|0.0653
72526588|NCT01012037|144583680|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.3|STANDARD_ERROR_OF_MEAN|5.4||0.0047||95.0|-25.8|-4.7|||Mixed Models Analysis|||Linagliptin 5mg qd versus Placebo||-4.7|-25.8|0.0047
72526589|NCT01012037|144583680|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.3|STANDARD_ERROR_OF_MEAN|3.0||||95.0|-0.7|11.3|||Mixed Models Analysis||No non-inferiority margin was pre-defined for FPG|Linagliptin 2.5mg bid versus Linagliptin 5mg qd||11.3|-0.7|
72526590|NCT00415623|144583694|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.7|||<|0.001||95.0|-9.0|-4.4|||ANCOVA|||The hypothesis of no group differences (null hypothesis) was tested against that of the amlodipine 10 mg arm being superior to the amlodipine 5 mg arm (alternative hypothesis). ANCOVA models with the trough SBP at baseline, body weight, and age as covariates, and the treatment group and study site as factors was used. The test was performed with a significance level of 0.05 (two-sided).||-4.4|-9.0|<0.001
72526591|NCT00415623|144583695|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.1|||<|0.001||95.0|-5.7|-2.5|||ANCOVA|||The hypothesis of no group differences (null hypothesis) was tested against that of the amlodipine 10 mg arm being superior to the amlodipine 5 mg arm (alternative hypothesis). ANCOVA models with the trough DBP at baseline, body weight, and age as covariates, and the treatment group and study site as factors was used. The test was performed with a significance level of 0.05 (two-sided).||-2.5|-5.7|<0.001
72526592|NCT00415623|144583696|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-7.1|||<|0.001||95.0|-9.1|-5.1|||ANCOVA|||The hypothesis of no group differences (null hypothesis) was tested against that of the amlodipine 10 mg arm being superior to the amlodipine 5 mg arm (alternative hypothesis). ANCOVA models with the trough SBP at baseline, body weight, and age as covariates, and the treatment group and study site as factors was used. The test was performed with a significance level of 0.05 (two-sided).||-5.1|-9.1|<0.001
72526593|NCT00415623|144583697|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.0|||<|0.001||95.0|-5.4|-2.6|||ANCOVA|||The hypothesis of no group differences (null hypothesis) was tested against that of the amlodipine 10 mg arm being superior to the amlodipine 5 mg arm (alternative hypothesis). ANCOVA models with the trough DBP at baseline, body weight, and age as covariates, and the treatment group and study site as factors was used. The test was performed with a significance level of 0.05 (two-sided).||-2.6|-5.4|<0.001
72526594|NCT00415623|144583698|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.33||||0.002||95.0|1.36|3.99|||Regression, Logistic|||Proportions of participants (responder rates) were used for the statistical analyses. The hypothesis of no group differences (null hypothesis) was tested against that of the amlodipine 10 mg arm being superior to the amlodipine 5 mg arm (alternative hypothesis). The test was conducted based on a logistic regression model with baseline SBP value and body weight as covariates, and treatment group and age (\<=64, \>=65) as a factor. The significance level was 0.05 (two-sided).||3.99|1.36|0.002
72526595|NCT00415623|144583699|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|4.46|||<|0.001||95.0|2.28|8.74|||Regression, Logistic|||Proportions of participants (responder rates) were used for the statistical analyses. The hypothesis of no group differences (null hypothesis) was tested against that of the amlodipine 10 mg arm being superior to the amlodipine 5 mg arm (alternative hypothesis). The test was conducted based on a logistic regression model with baseline SBP value and body weight as covariates, and treatment group and age (\<=64, \>=65) as a factor. The significance level was 0.05 (two-sided).||8.74|2.28|<0.001
72526596|NCT00415623|144583700|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.55||||0.001||95.0|1.5|4.36|||Regression, Logistic|||Proportions of participants (responder rates) were used for the statistical analyses. The hypothesis of no group differences (null hypothesis) was tested against that of the amlodipine 10 mg arm being superior to the amlodipine 5 mg arm (alternative hypothesis). The test was conducted based on a logistic regression model with baseline SBP value and body weight as covariates, and treatment group and age (\<=64, \>=65) as a factor. The significance level was 0.05 (two-sided).||4.36|1.50|0.001
72571344|NCT04709835|144671325|SUPERIORITY||Hazard Ratio (HR)|1.33|||||TWO_SIDED|80.0|0.76|2.32|||||Hazard ratio (80% CI) was estimated with a Cox proportional hazards model (unadjusted).|||2.32|0.76|
72407110|NCT02477020|144322865|SUPERIORITY_OR_OTHER||Least square mean difference|-1.2|STANDARD_ERROR_OF_MEAN|1.014||0.238|TWO_SIDED|95.0|-3.21|0.8||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. PANSS subscale score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction and Baseline PANSS subscale score-by-week interaction.|PANSS Positive Score, Change at Week 4||0.80|-3.21|0.238
72407111|NCT02477020|144322865|SUPERIORITY_OR_OTHER||Least square mean difference|-1.73|STANDARD_ERROR_OF_MEAN|1.051||0.102|TWO_SIDED|95.0|-3.81|0.35||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. PANSS subscale score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction and Baseline PANSS subscale score-by-week interaction.|PANSS Positive Score, Change at Week 5||0.35|-3.81|0.102
72407112|NCT02477020|144322865|SUPERIORITY_OR_OTHER||Least square mean difference|-1.6|STANDARD_ERROR_OF_MEAN|1.094||0.145|TWO_SIDED|95.0|-3.77|0.56||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. PANSS subscale score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction and Baseline PANSS subscale score-by-week interaction.|PANSS Positive Score, Change at Week 6||0.56|-3.77|0.145
72407113|NCT02477020|144322865|SUPERIORITY_OR_OTHER||Least square mean difference|0.06|STANDARD_ERROR_OF_MEAN|0.504||0.902|TWO_SIDED|95.0|-0.93|1.06||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. PANSS subscale score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction and Baseline PANSS subscale score-by-week interaction.|PANSS Negative Score, Change at Week 1||1.06|-0.93|0.902
72407114|NCT02477020|144322865|SUPERIORITY_OR_OTHER||MMRM|-0.59|STANDARD_ERROR_OF_MEAN|0.693||0.396|TWO_SIDED|95.0|-1.96|0.78||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. PANSS subscale score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction and Baseline PANSS subscale score-by-week interaction.|PANSS Negative Score, Change at Week 2||0.78|-1.96|0.396
72407115|NCT02477020|144322865|SUPERIORITY_OR_OTHER||Least square mean difference|-0.37|STANDARD_ERROR_OF_MEAN|0.722||0.612|TWO_SIDED|95.0|-1.79|1.06||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. PANSS subscale score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction and Baseline PANSS subscale score-by-week interaction.|PANSS Negative Score, Change at Week 3||1.06|-1.79|0.612
72407116|NCT02477020|144322865|SUPERIORITY_OR_OTHER||Least square mean difference|-0.37|STANDARD_ERROR_OF_MEAN|0.856||0.67|TWO_SIDED|95.0|-2.06|1.33||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. PANSS subscale score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction and Baseline PANSS subscale score-by-week interaction.|PANSS Negative Score, Change at Week 4||1.33|-2.06|0.670
72407117|NCT02477020|144322865|SUPERIORITY_OR_OTHER||Least square mean difference|-0.22|STANDARD_ERROR_OF_MEAN|0.892||0.807|TWO_SIDED|95.0|-1.98|1.55||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. PANSS subscale score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction and Baseline PANSS subscale score-by-week interaction.|PANSS Negative Score, Change at Week 5||1.55|-1.98|0.807
72526597|NCT00415623|144583701|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|4.16|||<|0.001||95.0|2.12|8.19|||Regression, Logistic|||Proportions of participants (responder rates) were used for the statistical analyses. The hypothesis of no group differences (null hypothesis) was tested against that of the amlodipine 10 mg arm being superior to the amlodipine 5 mg arm (alternative hypothesis). The test was conducted based on a logistic regression model with baseline SBP value and body weight as covariates, and treatment group and age (\<=64, \>=65) as a factor. The significance level was 0.05 (two-sided).||8.19|2.12|<0.001
72407118|NCT02477020|144322865|SUPERIORITY_OR_OTHER||Least square mean difference|-1.14|STANDARD_ERROR_OF_MEAN|0.853||0.182|TWO_SIDED|95.0|-2.83|0.54||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. PANSS subscale score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction and Baseline PANSS subscale score-by-week interaction.|PANSS Negative Score, Change at Week 6||0.54|-2.83|0.182
72407119|NCT02477020|144322865|SUPERIORITY_OR_OTHER||Least square mean difference|0.07|STANDARD_ERROR_OF_MEAN|0.801||0.933|TWO_SIDED|95.0|-1.52|1.65||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. PANSS subscale score as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction and Baseline PANSS subscale score-by-week interaction.|PANSS General Score, Change at Week 1||1.65|-1.52|0.933
72407120|NCT02477020|144322865|SUPERIORITY_OR_OTHER||Least square mean difference|-0.61|STANDARD_ERROR_OF_MEAN|1.151||0.596|TWO_SIDED|95.0|-2.89|1.66||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. PANSS subscale score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction and Baseline PANSS subscale score-by-week interaction.|PANSS General Score, Change at Week 2||1.66|-2.89|0.596
72526598|NCT00542425|144583704|SUPERIORITY_OR_OTHER||||||<|0.001||0.0|||||ANOVA|||Study size provided 95 percent power to detect a difference in means of 114 (ng/mL) for PINP endpoint between BA058 (SD=147.5) and placebo (SD=34.5). Study size was based on Bauer 2006 data and utilized a 2-tailed 2-sample t-test with a significance level of alpha=0.01 with a Bonferonni adjustment for multiple testing. It included a 10 percent adjustment for within study dropouts over 6 months and a 15 percent adjustment to maintain adequate power for a per protocol analysis of key endpoints.||||<0.001
72526599|NCT00542425|144583704|SUPERIORITY_OR_OTHER||||||<|0.001||0.0|||||ANOVA|||Study size provided 95 percent power to detect a difference in means of 114 (ng/mL) for PINP endpoint between BA058 (SD=147.5) and placebo (SD=34.5). Study size was based on Bauer 2006 data and utilized a 2-tailed 2-sample t-test with a significance level of alpha=0.01 with a Bonferonni adjustment for multiple testing. It included a 10 percent adjustment for within study dropouts over 6 months and a 15 percent adjustment to maintain adequate power for a per protocol analysis of key endpoints.||||<0.001
72526600|NCT00542425|144583705|SUPERIORITY_OR_OTHER||||||<|0.001||0.0|||||ANOVA|||For the BMD endpoint, the planned study size has 80 percent power with alpha=0.02 to detect a difference in mean change from baseline of 3.0 (percent) in BMD for the BA058 group and the BA058 Placebo group using an assumed SD of 3.5-4.0. The estimates for SD are based upon results of lumbar spine BMD presented by Body 2002.||||<0.001
72526601|NCT00542425|144583705|SUPERIORITY_OR_OTHER||||||<|0.001||0.0|||||ANOVA|||For the BMD endpoint, the planned study size has 80 percent power with alpha=0.02 to detect a difference in mean change from baseline of 3.0 (percent) in BMD for the BA058 group and the BA058 Placebo group using an assumed SD of 3.5-4.0. The estimates for SD are based upon results of lumbar spine BMD presented by Body 2002.||||<0.001
72526602|NCT01601873|144583709|SUPERIORITY|||||||0.884|||||||Wilcoxon (Mann-Whitney)|||||||0.884
72526603|NCT01601873|144583710|SUPERIORITY|||||||0.946|||||||Wilcoxon (Mann-Whitney)|||||||0.946
72526604|NCT01601873|144583711|SUPERIORITY|||||||0.294|||||||Wilcoxon (Mann-Whitney)|||||||0.294
72526605|NCT01601873|144583712|SUPERIORITY|||||||0.538|||||||Log Rank|||||||0.538
72526606|NCT01601873|144583713|SUPERIORITY|||||||0.786|||||||Log Rank|||||||0.786
72526607|NCT01601873|144583714|SUPERIORITY|||||||0.185|||||||Log Rank|||||||0.185
72526608|NCT02096471|144583724|SUPERIORITY|Single group study. Change in Pain from Baseline amongst those with a tumor response|Mean Difference (Final Values)|1.38|STANDARD_ERROR_OF_MEAN|0.84||0.11|TWO_SIDED||||||t-test, 2 sided|Descriptive analysis only||Single group change from baseline||||0.11
72526609|NCT02096471|144583724|SUPERIORITY|Single Group Study. Change in Pain from Baseline amongst those with a Tumor Response.|Mean Difference (Final Values)|2.1|STANDARD_ERROR_OF_MEAN|0.8||0.01|TWO_SIDED||||||t-test, 2 sided|Descriptive Analysis Only||Single Group Change from Baseline||||0.01
72526610|NCT02096471|144583724|SUPERIORITY|Single Group Study. Change in Pain from Baseline amongst those with a Tumor Response|Mean Difference (Final Values)|0.89|STANDARD_ERROR_OF_MEAN|0.66||0.18|TWO_SIDED||||||t-test, 2 sided|Descriptive Analysis Only||Single Group Change from Baseline||||0.18
72526611|NCT02096471|144583724|SUPERIORITY|Single Group Study. Change in Quality of Life (QOL) from Baseline amongst those with a Tumor Response|Mean Difference (Final Values)|-3.77|STANDARD_ERROR_OF_MEAN|3.6||0.3|TWO_SIDED||||||t-test, 2 sided|Descriptive Analysis Only||Single Group Change from Baseline||||0.30
72526612|NCT02096471|144583724|SUPERIORITY|Single Group Study Change in Quality of Life from Baseline amongst those with a Tumor Response|Mean Difference (Final Values)|-3.55|STANDARD_ERROR_OF_MEAN|6.87||0.61|TWO_SIDED||||||t-test, 2 sided|Descriptive Analysis Only||Single Group Change from Baseline||||0.61
72526613|NCT02096471|144583724|SUPERIORITY|Single Group Study Change in Baseline amongst those with a Tumor Response|Mean Difference (Final Values)|-13.06|STANDARD_ERROR_OF_MEAN|8.29||0.12|TWO_SIDED||||||t-test, 2 sided|Descriptive Analysis Only||Single Group Change from Baseline||||0.12
72526614|NCT02096471|144583724|SUPERIORITY|Single Group Study. Change in Quality of Life from Baseline amongst those with a Tumor Response.|Mean Difference (Final Values)|-12.98|STANDARD_ERROR_OF_MEAN|6.35||0.05|TWO_SIDED||||||t-test, 2 sided|Descriptive Analysis Only.||Single Group Change from Baseline||||0.05
72526615|NCT02096471|144583724|SUPERIORITY|Single Group Study. Change in Quality of Life from Baseline amongst those with a Tumor Response.|Mean Difference (Final Values)|6.66|STANDARD_ERROR_OF_MEAN|5.05||0.19|TWO_SIDED||||||t-test, 2 sided|Descriptive Analysis Only||Single Group Change from Baseline||||0.19
72526616|NCT02096471|144583724|SUPERIORITY|Single Group Study. Change in Quality of Life from Baseline amongst those with a Tumor Response.|Mean Difference (Final Values)|-2.34|STANDARD_ERROR_OF_MEAN|6.46||0.72|TWO_SIDED||||||t-test, 2 sided|Descriptive Analysis Only||Single Group Change from Baseline||||0.72
72526617|NCT02096471|144583724|SUPERIORITY|Single Group Study. Change in Quality of Life from Baseline amongst those with a Tumor Response.|Mean Difference (Final Values)|-6.24|STANDARD_ERROR_OF_MEAN|6.74||0.36|TWO_SIDED||||||t-test, 2 sided|Descriptive Analysis Only||Single Group Change from Baseline||||0.36
72526618|NCT02096471|144583724|SUPERIORITY|Single Group Study. Change in Quality of Life from Baseline amongst those with a Tumor Response.|Mean Difference (Final Values)|-0.17|STANDARD_ERROR_OF_MEAN|6.37||0.98|TWO_SIDED||||||t-test, 2 sided|Descriptive Analysis Only||Single Group Change from Baseline||||0.98
72526619|NCT02096471|144583724|SUPERIORITY|Single Group Study. change in Quality of Life from Baseline amongst those with a Tumor Response.|Mean Difference (Final Values)|0.68|STANDARD_ERROR_OF_MEAN|7.99||0.93|TWO_SIDED||||||t-test, 2 sided|Descriptive Analysis Only||Single Group Change from Baseline||||0.93
72526620|NCT02096471|144583724|SUPERIORITY|Single Group Study. Change in Quality of Life from Baseline amongst those with a Tumor Response.|Mean Difference (Final Values)|-10.97|STANDARD_ERROR_OF_MEAN|8.16||0.19|TWO_SIDED||||||t-test, 2 sided|Descriptive Analysis Only||Single Group Change from Baseline||||0.19
72526621|NCT02096471|144583724|SUPERIORITY|Single Group Study. Change in Quality of Life from Baseline amongst those with a Tumor Response.|Mean Difference (Final Values)|-3.74|STANDARD_ERROR_OF_MEAN|6.58||0.57|TWO_SIDED||||||t-test, 2 sided|Descriptive Analysis Only||Single Group Change from Baseline||||0.57
72526622|NCT02096471|144583724|SUPERIORITY|Single Group Study. Change in Quality of Life from Baseline amongst those with a Tumor Response.|Mean Difference (Final Values)|-4.21|STANDARD_ERROR_OF_MEAN|5.51||0.45|TWO_SIDED||||||t-test, 2 sided|Descriptive Analysis Only||Single Group Change from Baseline||||0.45
72526623|NCT02096471|144583724|SUPERIORITY|Single Group Study. Change in Quality of Life from Baseline amongst those with a Tumor Response.|Mean Difference (Final Values)|-6.27|STANDARD_ERROR_OF_MEAN|5.72||0.28|TWO_SIDED||||||t-test, 2 sided|Descriptive Analysis Only||Single Group Change from Baseline||||0.28
72526624|NCT02096471|144583724|SUPERIORITY|Single Group Study. Change in Quality of Life from Baseline amongst those with a Tumor Response.|Mean Difference (Final Values)|-0.71|STANDARD_ERROR_OF_MEAN|8.52||0.93|TWO_SIDED||||||t-test, 2 sided|Descriptive Analysis Only||Single Group Change from Baseline||||0.93
72526625|NCT02096471|144583724|SUPERIORITY|Single Group Study. Change in Quality of Life from Baseline amongst those with a Tumor Response.|Mean Difference (Final Values)|-1.07|STANDARD_ERROR_OF_MEAN|7.53||0.89|TWO_SIDED||||||t-test, 2 sided|Descriptive Analysis Only||Single Group Change from Baseline||||0.89
72526626|NCT02449915|144583727|OTHER|||||||0.52|||||||Wilcoxon (Mann-Whitney)|||||||0.52
72526627|NCT01855919|144583748|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.46||||0.0026|TWO_SIDED|95.0|-0.77|-0.16|||Mixed Models Analysis|||||-0.16|-0.77|0.0026
72526628|NCT01855919|144583749|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.29||||0.0026|TWO_SIDED|95.0|-0.48|-0.1|||Mixed Models Analysis|||||-0.10|-0.48|0.0026
72526629|NCT01855919|144583750|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.64||||0.0439|TWO_SIDED|95.0|-1.25|-0.02|||ANCOVA|||||-0.02|-1.25|0.0439
72526630|NCT01855919|144583751|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.3||||0.101|TWO_SIDED|95.0|-0.66|0.06||p-value is for worst pain|Mixed Models Analysis|||||0.06|-0.66|0.1010
72526631|NCT01855919|144583751|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5||||0.0009|TWO_SIDED|95.0|-0.79|-0.21||p-value is for least pain|Mixed Models Analysis|||||-0.21|-0.79|0.0009
72526632|NCT01855919|144583751|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4||||0.023|TWO_SIDED|95.0|-0.74|-0.05||p-value is for Pain Right Now|Mixed Models Analysis|||||-0.05|-0.74|0.0230
72526633|NCT01855919|144583751|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.31||||0.0874|TWO_SIDED|95.0|-0.66|0.05||p-value is for General Activity|Mixed Models Analysis|||||0.05|-0.66|0.0874
72526634|NCT01855919|144583751|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.32||||0.0436|TWO_SIDED|95.0|-0.63|-0.01||p-value is for Mood|Mixed Models Analysis|||||-0.01|-0.63|0.0436
72526635|NCT01855919|144583751|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.14||||0.3902|TWO_SIDED|95.0|-0.45|0.18||p-value is for Walking Ability|Mixed Models Analysis|||||0.18|-0.45|0.3902
72526636|NCT01855919|144583751|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.991|TWO_SIDED|95.0|-0.33|0.33||p-value is for Normal Work|Mixed Models Analysis|||||0.33|-0.33|0.9910
72526637|NCT01855919|144583751|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.04||||0.7848|TWO_SIDED|95.0|-0.3|0.23||p-value is for Relationship People|Mixed Models Analysis|||||0.23|-0.30|0.7848
72526638|NCT01855919|144583751|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01||||0.9424|TWO_SIDED|95.0|-0.32|0.3||p-value is for Sleep|Mixed Models Analysis|||||0.30|-0.32|0.9424
72526639|NCT01855919|144583751|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.04||||0.7932|TWO_SIDED|95.0|-0.35|0.27||p-value is for Enjoyment of Life|Mixed Models Analysis|||||0.27|-0.35|0.7932
72526640|NCT01855919|144583751|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.12||||0.3761|TWO_SIDED|95.0|-0.4|0.15||p-value is for Average of 7 Items|Mixed Models Analysis|||||0.15|-0.40|0.3761
72526641|NCT01855919|144583752|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.42||||0.0049|TWO_SIDED|95.0|-0.71|-0.13||p-value is for Average Pain|Mixed Models Analysis|||||-0.13|-0.71|0.0049
72526642|NCT01855919|144583752|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.35||||0.0442|TWO_SIDED|95.0|-0.69|-0.01||p-value is for Worst pain|Mixed Models Analysis|||||-0.01|-0.69|0.0442
72526643|NCT01855919|144583753|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.31||||0.0003|TWO_SIDED|95.0|1.13|1.53||p-value is for ≥30%|Mantel Haenszel|||||1.53|1.13|0.0003
72526644|NCT01855919|144583753|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.43||||0.0003|TWO_SIDED|95.0|1.18|1.75||p-value is for ≥50%|Mantel Haenszel|||||1.75|1.18|0.0003
72526645|NCT01855919|144583754|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.33||||0.0012|TWO_SIDED|95.0|1.12|1.58|||Mantel Haenszel|||||1.58|1.12|0.0012
72526646|NCT01855919|144583755|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.28||||0.0019|TWO_SIDED|95.0|-0.46|-0.1|||Mixed Models Analysis|||||-0.10|-0.46|0.0019
72526647|NCT01855919|144583756|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.35||||0.3012|TWO_SIDED|95.0|-1.03|0.32|||ANCOVA|||||0.32|-1.03|0.3012
72526648|NCT01855919|144583757|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.27||||0.2581|TWO_SIDED|95.0|-0.93|3.47||p-value for Physical Functioning|ANCOVA|||||3.47|-0.93|0.2581
72526649|NCT01855919|144583757|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.58||||0.7208|TWO_SIDED|95.0|-2.62|3.79||p-value for Role (Physical)|ANCOVA|||||3.79|-2.62|0.7208
72526650|NCT01855919|144583757|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.55||||0.2487|TWO_SIDED|95.0|-1.09|4.19||p-value for Bodily Pain|ANCOVA|||||4.19|-1.09|0.2487
72526651|NCT01855919|144583757|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.94||||0.0151|TWO_SIDED|95.0|0.57|5.31||p-value for General Health|ANCOVA|||||5.31|0.57|0.0151
72526652|NCT01855919|144583757|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.16||||0.4|TWO_SIDED|95.0|-1.54|3.85||p-value for Vitality|ANCOVA|||||3.85|-1.54|0.4000
72526653|NCT01855919|144583757|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.63||||0.2529|TWO_SIDED|95.0|-1.17|4.43||p-value for Social Functioning|ANCOVA|||||4.43|-1.17|0.2529
72526654|NCT01855919|144583757|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4||||0.8042|TWO_SIDED|95.0|-3.55|2.75||p-value for Role(Emotional)|ANCOVA|||||2.75|-3.55|0.8042
72526655|NCT01855919|144583757|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.21||||0.0058|TWO_SIDED|95.0|0.94|5.48||p-value is for Mental Health|ANCOVA|||||5.48|0.94|0.0058
72526656|NCT01855919|144583758|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01||||0.5237|TWO_SIDED|95.0|-0.02|0.03|||ANCOVA|||||0.03|-0.02|0.5237
72526657|NCT01855919|144583759|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02||||0.046|TWO_SIDED|95.0|-0.05|0.0||p-value for Work time missed|ANCOVA|||||0.00|-0.05|0.0460
72526658|NCT01855919|144583759|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.04||||0.0753|TWO_SIDED|95.0|-0.08|0.0||p-value for Impairment at work|ANCOVA|||||0.00|-0.08|0.0753
72526659|NCT01855919|144583759|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.04||||0.0795|TWO_SIDED|95.0|-0.08|0.0||p-value for Work productivity loss|ANCOVA|||||0.00|-0.08|0.0795
72526660|NCT01855919|144583759|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.03||||0.1466|TWO_SIDED|95.0|-0.06|0.01||p-value for Work activity impairment|ANCOVA|||||0.01|-0.06|0.1466
72526661|NCT03455530|144583767|SUPERIORITY||Mean Difference (Final Values)|0.73|||||TWO_SIDED|95.0|0.45|1.19|||Mixed Models Analysis||Ratio based on the mean difference from the log scale.|||1.19|0.45|
72526662|NCT03455530|144583767|SUPERIORITY||Mean Difference (Final Values)|1.34|||||TWO_SIDED|95.0|0.55|3.24|||Mixed Models Analysis||Ratio based on the mean difference from the log scale.|||3.24|0.55|
72526663|NCT00740116|144583779|SUPERIORITY|||||||0.03||||||Statistical significance threshold was p \< 0.05|Wilcoxon (Mann-Whitney)|Mann-Whitney U-test, one-sided test||||||0.03
72526664|NCT00740116|144583780|SUPERIORITY|||||||0.07||||||Statistical significance threshold was p \< 0.05|Wilcoxon (Mann-Whitney)|Mann-Whitney U-test, one-sided test||||||0.07
72526665|NCT00740116|144583781|SUPERIORITY||Odds Ratio (OR)|0.44||||0.46|ONE_SIDED|95.0||0.97||Statistical significance threshold was p \< 0.05|Wilcoxon (Mann-Whitney)|Mann-Whitney U-test, one-sided test||||0.97||0.46
72526666|NCT00740116|144583782|SUPERIORITY|||||||0.46||||||p\< 0.05 for statistical significance|Wilcoxon (Mann-Whitney)|||||||0.46
72526667|NCT00740116|144583783|SUPERIORITY||Odds Ratio (OR)|0.36||||0.22|TWO_SIDED|95.0|0.05|2.72||Statistical significance threshold p-value \< 0.05|Fisher Exact|||||2.72|0.05|0.22
72526668|NCT00121485|144583785|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|200 patients (137 HMII and 67 XVE) provides 80% power (alpha= 0.05 (one-sided)) using a Blackwelder like analysis and a non-inferiority margin of 10%. The protocol specifies that once non-inferiority is proven, the data will be analyzed for superiority using closed testing methods.|Mean Difference (Final Values)|35.7||||2.5e-07|TWO_SIDED|95.0|24.5|46.9||Two (2) interim analysis were pre-specified in the protocol. The type I error rate was preserved at 5% by use of the O'Brien-Fleming spending function.|Fisher Exact|||Primary endpoint is 2-yr survival free of stroke or re-operation to repair/replace the device. Patients are a success if composite endpoint achieved. Patients urgently transplanted due to device failure are failures. Patients electively transplanted after reversal of co-morbidity will be considered success if they achieve 2 years of survival from day of VAD implant and no stroke. HMII is a success if the proportion of HMII pts achieving the composite endpoint is equal to or better than HM XVE||46.9|24.5|0.00000025
72526669|NCT01111331|144583800|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability.|Geometric Mean ratio|100.89|STANDARD_DEVIATION|7.0|||TWO_SIDED|90.0|96.86|105.1|||ANOVA|Based on ANOVA with terms for subject and treatment|Standard deviation is actually the intra-individual geometric coefficient of variation (gCV)|Ratio calculated as empa plus warfarin divided by empa||105.10|96.86|
72526670|NCT01111331|144583801|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability.|Geometric Mean Ratio|100.64|STANDARD_DEVIATION|19.9||0.0021|TWO_SIDED|90.0|89.79|112.8||p-value for geometric mean ratio being outside interval 80% to 125%|ANOVA|Based on ANOVA with terms for subject and treatment|Standard deviation is actually the intra-individual gCV|Ratio calculated as empa plus warfarin divided by empa||112.80|89.79|0.0021
72526671|NCT01111331|144583802|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability.|Geometric Mean Ratio|98.49|STANDARD_DEVIATION|5.7|||TWO_SIDED|90.0|95.29|101.8|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment|Standard deviation is actually the geometric coefficient of variation (gCV)|Ratio calculated as empa plus warfarin divided by warfarin||101.80|95.29|
72526672|NCT01111331|144583803|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability.|Geometric Mean Ratio|97.89|STANDARD_DEVIATION|12.4||0.0001|TWO_SIDED|90.0|91.12|105.15|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment|Standard deviation is actually the geometric coefficient of variation (gCV)|Ratio calculated as empa plus warfarin divided by warfarin||105.15|91.12|0.0001
72526673|NCT01111331|144583804|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability.|Geometric Mean Ratio|95.88|STANDARD_DEVIATION|4.5|||TWO_SIDED|90.0|93.4|98.43|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment|Standard deviation is actually the intra-individual gCV|Ratio calculated as empa plus warfarin divided by warfarin||98.43|93.40|
72526674|NCT01111331|144583805|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability.|Geometric Mean Ratio|98.88|STANDARD_DEVIATION|12.7||0.0001|TWO_SIDED|90.0|91.84|106.47||p-value for geometric mean ratio being outside interval 80% to 125%|ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment|Standard deviation is actually the intra-individual gCV|Ratio calculated as empa plus warfarin divided by warfarin||106.47|91.84|0.0001
72526675|NCT01111331|144583813|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability.|Geometric Mean Ratio|98.9|STANDARD_DEVIATION|5.3|||TWO_SIDED|90.0|95.89|102.0|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment|Standard deviation is actually the geometric coefficient of variation (gCV)|Ratio calculated as empa plus warfarin divided by warfarin||102.00|95.89|
72526676|NCT01111331|144583820|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability.|Geometric Mean Ratio|96.09|STANDARD_DEVIATION|4.4|||TWO_SIDED|90.0|93.64|98.6|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment|Standard deviation is actually the intra-individual gCV|Ratio calculated as empa plus warfarin divided by warfarin||98.60|93.64|
72526677|NCT01111331|144583827|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability.|Geometric mean ratio|0.87|||||TWO_SIDED|95.0|0.73|1.04|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period, treatment and the baseline INR value||Difference calculated as empa plus warfarin minus warfarin||1.04|0.73|
72526678|NCT01111331|144583828|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability.|Geometric mean ratio|0.88|||||TWO_SIDED|95.0|0.79|0.98|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period, treatment and the baseline INR value||Difference calculated as empa plus warfarin minus warfarin||0.98|0.79|
72526679|NCT01111331|144583829|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability.|Geometric mean ratio|0.99|||||TWO_SIDED|95.0|0.67|1.48|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period, treatment and the baseline INR value||Difference calculated as empa plus warfarin minus warfarin||1.48|0.67|
72526680|NCT01111331|144583830|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability.|Geometric mean ratio|0.9|||||TWO_SIDED|95.0|0.79|1.02|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period, treatment and the baseline PT value||Difference calculated as empa plus warfarin minus warfarin||1.02|0.79|
72571345|NCT04709835|144671326|SUPERIORITY||Hazard Ratio (HR)|0.86|||||TWO_SIDED|80.0|0.44|1.7|||||Hazard ratio (80% CI) was estimated with a Cox proportional hazards model (unadjusted).|||1.70|0.44|
72571346|NCT04709835|144671326|SUPERIORITY||Hazard Ratio (HR)|1.06|||||TWO_SIDED|80.0|0.56|2.03|||||Hazard ratio (80% CI) was estimated with a Cox proportional hazards model (unadjusted).|||2.03|0.56|
72571347|NCT04709835|144671327|SUPERIORITY||Difference in Percentage of Positivity|5.0|||||TWO_SIDED|80.0|-0.16|10.16|||||Confidence interval estimated with the Farrington-Manning method.|Day 3||10.16|-0.16|
72571348|NCT04709835|144671327|SUPERIORITY||Difference in Percentage of Positivity|-1.9|||||TWO_SIDED|80.0|-9.2|5.41|||||Confidence interval estimated with the Farrington-Manning method.|Day 3||5.41|-9.20|
72571349|NCT04709835|144671327|SUPERIORITY||Difference in Percentage of Positivity|5.79|||||TWO_SIDED|80.0|-4.82|16.4|||||Confidence interval estimated with the Farrington-Manning method.|Day 5||16.40|-4.82|
72571350|NCT04709835|144671327|SUPERIORITY||Difference in Percentage of Positivity|-0.88|||||TWO_SIDED|80.0|-12.4|10.65|||||Confidence interval estimated with the Farrington-Manning method.|Day 5||10.65|-12.40|
72571351|NCT04709835|144671327|SUPERIORITY||Difference in Percentage of Positivity|2.39|||||TWO_SIDED|80.0|-10.64|15.42|||||Confidence interval estimated with the Farrington-Manning method.|Day 7||15.42|-10.64|
72526681|NCT01111331|144583831|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability.|Geometric mean ratio|1.12|||||TWO_SIDED|95.0|0.64|1.95|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period, treatment and the baseline PT value||Difference calculated as empa plus warfarin minus warfarin||1.95|0.64|
72526682|NCT01111331|144583832|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability.|Geometric mean ratio|0.91|||||TWO_SIDED|95.0|0.84|0.98|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period, treatment and the baseline PT value||Difference calculated as empa plus warfarin minus warfarin||0.98|0.84|
72526683|NCT01111331|144583833|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability.|Geometric mean ratio|0.97|||||TWO_SIDED|95.0|0.68|1.4|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period, treatment and the baseline PT value||Difference calculated as empa plus warfarin minus warfarin||1.40|0.68|
72526684|NCT01111331|144583834|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability.|Geometric mean ratio|0.85|||||TWO_SIDED|95.0|0.47|1.51|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period, treatment and the baseline PT value||Difference calculated as empa plus warfarin minus warfarin||1.51|0.47|
72526685|NCT03031327|144583838|SUPERIORITY||Mean Difference (Final Values)|2.9||||0.3474|TWO_SIDED|95.0|-3.3|9.1|||ANOVA|Analysis of variance for repeated measures||Dryness - Study eye - Day 15±2 The model included fixed effect terms for time point, baseline covariate (i.e. the day 1 - pre-dose value) and treatment. Time point was specified as a repeated measurement.||9.1|-3.3|0.3474
72526686|NCT03031327|144583838|SUPERIORITY||Mean Difference (Final Values)|-1.9||||0.1327|TWO_SIDED|95.0|-8.2|4.3|||ANOVA|||Analysis of variance on changes from baseline in ocular tolerability - Dryness - Study eye - Day 15±2||4.3|-8.2|0.1327
72526687|NCT03031327|144583838|SUPERIORITY||Mean Difference (Final Values)|-4.8||||0.1327|TWO_SIDED|95.0|-11.2|1.6|||ANOVA|||Analysis of variance on changes from baseline in ocular tolerability - Dryness - Study eye - Day 15±2||1.6|-11.2|0.1327
72526688|NCT03031327|144583838|SUPERIORITY||Mean Difference (Final Values)|3.8||||0.2237|TWO_SIDED|95.0|-2.5|10.0|||ANOVA|||Analysis of variance on changes from baseline in ocular tolerability - Foreign body sensation - Study eye - Day 15±2||10.0|-2.5|0.2237
72526689|NCT03031327|144583838|SUPERIORITY||Mean Difference (Final Values)|-2.1||||0.4905|TWO_SIDED|95.0|-8.4|4.1|||ANOVA|||Analysis of variance on changes from baseline in ocular tolerability - Foreign body sensation - Study eye - Day 15±2||4.1|-8.4|0.4905
72526690|NCT03031327|144583838|SUPERIORITY||Mean Difference (Final Values)|-5.9||||0.0687|TWO_SIDED|95.0|-12.3|0.5|||ANOVA|||Analysis of variance on changes from baseline in ocular tolerability - Foreign body sensation - Study eye - Day 15±2||0.5|-12.3|0.0687
72526691|NCT03031327|144583838|SUPERIORITY||Mean Difference (Final Values)|0.7||||0.7609|TWO_SIDED|95.0|-4.2|5.6|||ANOVA|||Analysis of variance on changes from baseline in ocular tolerability - Burning/Stinging - Study eye - Day 15±2||5.6|-4.2|0.7609
72526692|NCT03031327|144583838|SUPERIORITY||Mean Difference (Final Values)|-1.1||||0.6428|TWO_SIDED|95.0|-6.0|3.8|||ANOVA|||Analysis of variance on changes from baseline in ocular tolerability - Burning/Stinging - Study eye - Day 15±2||3.8|-6.0|0.6428
72526693|NCT03031327|144583838|SUPERIORITY||Mean Difference (Final Values)|-1.8||||0.4599|TWO_SIDED|95.0|-6.9|3.2|||ANOVA|||Analysis of variance on changes from baseline in ocular tolerability - Burning/Stinging - Study eye - Day 15±2||3.2|-6.9|0.4599
72526694|NCT03031327|144583838|SUPERIORITY||Mean Difference (Final Values)|3.0||||0.4217|TWO_SIDED|95.0|-4.6|10.5|||ANOVA|||Analysis of variance on changes from baseline in ocular tolerability - Itching - Study eye - Day 15±2||10.5|-4.6|0.4217
72526695|NCT03031327|144583838|SUPERIORITY||Mean Difference (Final Values)|0.503||||-2.5|TWO_SIDED|95.0|-10.0|5.0|||ANOVA|||Analysis of variance on changes from baseline in ocular tolerability - Itching - Study eye - Day 15±2||5.0|-10.0|-2.5
72526696|NCT03031327|144583838|SUPERIORITY||Mean Difference (Final Values)|-1.8||||0.4599|TWO_SIDED|95.0|-6.9|3.2|||ANOVA|||Analysis of variance on changes from baseline in ocular tolerability - Itching - Study eye - Day 15±2||3.2|-6.9|0.4599
72526697|NCT03031327|144583838|SUPERIORITY||Mean Difference (Final Values)|0.9||||0.6157|TWO_SIDED|95.0|-2.6|4.4|||ANOVA|||Analysis of variance on changes from baseline in ocular tolerability - Pain - Study eye - Day 15±2||4.4|-2.6|0.6157
72526698|NCT03031327|144583838|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.912|TWO_SIDED|95.0|-3.7|3.3|||ANOVA|||Analysis of variance on changes from baseline in ocular tolerability - Pain - Study eye - Day 15±2||3.3|-3.7|0.9120
72526699|NCT03031327|144583838|SUPERIORITY||Mean Difference (Final Values)|-1.1||||0.5463|TWO_SIDED|95.0|-4.6|2.5|||ANOVA|||Analysis of variance on changes from baseline in ocular tolerability - Pain - Study eye - Day 15±2||2.5|-4.6|0.5463
72526700|NCT03031327|144583838|SUPERIORITY||Mean Difference (Final Values)|-0.3||||0.9065|TWO_SIDED|95.0|-5.9|5.3|||ANOVA|||Analysis of variance on changes from baseline in ocular tolerability - Sticky Feeling - Study eye - Day 15±2||5.3|-5.9|0.9065
72526701|NCT03031327|144583838|SUPERIORITY||Mean Difference (Final Values)|-1.8||||0.5065|TWO_SIDED|95.0|-7.3|3.7|||ANOVA|||Analysis of variance on changes from baseline in ocular tolerability - Sticky Feeling - Study eye - Day 15±2||3.7|-7.3|0.5065
72526702|NCT03031327|144583838|SUPERIORITY||Mean Difference (Final Values)|-1.5||||0.5977|TWO_SIDED|95.0|-7.1|4.2|||ANOVA|||Analysis of variance on changes from baseline in ocular tolerability - Sticky Feeling - Study eye - Day 15±2||4.2|-7.1|0.5977
72526703|NCT03031327|144583838|SUPERIORITY||Mean Difference (Final Values)|-2.2||||0.2785|TWO_SIDED|95.0|-6.3|1.9|||ANOVA|||Analysis of variance on changes from baseline in ocular tolerability - Blurred Vision - Study eye - Day 15±2||1.9|-6.3|0.2785
72526704|NCT03031327|144583838|SUPERIORITY||Mean Difference (Final Values)|-0.6||||0.7454|TWO_SIDED|95.0|-4.6|3.3|||ANOVA|||Analysis of variance on changes from baseline in ocular tolerability - Blurred vision - Study eye - Day 15±2||3.3|-4.6|0.7454
72526705|NCT03031327|144583838|SUPERIORITY||Mean Difference (Final Values)|1.6||||0.4588|TWO_SIDED|95.0|-2.7|5.9|||ANOVA|||Analysis of variance on changes from baseline in ocular tolerability - Blurred vision - Study eye - Day 15±2||5.9|-2.7|0.4588
72526706|NCT03031327|144583838|SUPERIORITY||Mean Difference (Final Values)|4.3||||0.2812|TWO_SIDED|95.0|-3.7|12.3|||ANOVA|||Analysis of variance on changes from baseline in ocular tolerability - Photophobia - Study eye - Day 15±2||12.3|-3.7|0.2812
72526707|NCT03031327|144583838|SUPERIORITY||Mean Difference (Final Values)|1.6||||0.6811|TWO_SIDED|95.0|-6.5|9.8|||ANOVA|||Analysis of variance on changes from baseline in ocular tolerability - Photophobia - Study eye - Day 15±2||9.8|-6.5|0.6811
72407121|NCT02477020|144322865|SUPERIORITY_OR_OTHER||Least square mean difference|-1.31|STANDARD_ERROR_OF_MEAN|1.455||0.371|TWO_SIDED|95.0|-4.18|1.57||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. PANSS subscale score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction and Baseline PANSS subscale score-by-week interaction.|PANSS General Score, Change at Week 3||1.57|-4.18|0.371
72526708|NCT03031327|144583838|SUPERIORITY||Mean Difference (Final Values)|-2.6||||0.5169|TWO_SIDED|95.0|-10.8|5.6|||ANOVA|||Analysis of variance on changes from baseline in ocular tolerability - Photophobia - Study eye - Day 15±2||5.6|-10.8|0.5169
72526709|NCT03031327|144583838|SUPERIORITY||Mean Difference (Final Values)|0.9||||0.7874|TWO_SIDED|95.0|-5.9|7.8|||ANOVA|||Analysis of variance on changes from baseline in ocular tolerability - Dryness - Non Study eye - Day 15±2||7.8|-5.9|0.7874
72526710|NCT03031327|144583838|SUPERIORITY||Mean Difference (Final Values)|-0.7||||0.8299|TWO_SIDED|95.0|-7.6|6.1|||ANOVA|||Analysis of variance on changes from baseline in ocular tolerability - Dryness - Non Study eye - Day 15±2||6.1|-7.6|0.8299
72526711|NCT03031327|144583838|SUPERIORITY||Mean Difference (Final Values)|-1.6||||0.6386|TWO_SIDED|95.0|-8.7|5.4|||ANOVA|||Analysis of variance on changes from baseline in ocular tolerability - Dryness - Non Study eye - Day 15±2||5.4|-8.7|0.6386
72526712|NCT03031327|144583838|SUPERIORITY||Mean Difference (Final Values)|5.7||||0.0132|TWO_SIDED|95.0|1.3|10.2|||ANOVA|||Analysis of variance on changes from baseline in ocular tolerability - Foreign body sensation - Non Study eye - Day 15±2||10.2|1.3|0.0132
72526713|NCT03031327|144583838|SUPERIORITY||Mean Difference (Final Values)|-0.8||||0.7177|TWO_SIDED|95.0|-5.3|3.7|||ANOVA|||Analysis of variance on changes from baseline in ocular tolerability - Foreign body sensation - Non Study eye - Day 15±2||3.7|-5.3|0.7177
72526714|NCT03031327|144583838|SUPERIORITY||Mean Difference (Final Values)|-6.5||||0.0077|TWO_SIDED|95.0|-11.2|-1.9|||ANOVA|||Analysis of variance on changes from baseline in ocular tolerability - Foreign body sensation - Non Study eye - Day 15±2||-1.9|-11.2|0.0077
72526715|NCT03031327|144583838|SUPERIORITY||Mean Difference (Final Values)|5.3||||0.0301|TWO_SIDED|95.0|0.6|10.0|||ANOVA|||Analysis of variance on changes from baseline in ocular tolerability - Burning/Stinging - Non Study eye - Day 15±2||10.0|0.6|0.0301
72526716|NCT03031327|144583838|SUPERIORITY||Mean Difference (Final Values)|0.4||||0.8657|TWO_SIDED|95.0|-4.3|5.1|||ANOVA|||Analysis of variance on changes from baseline in ocular tolerability - Burning/Stinging - Non Study eye - Day 15±2||5.1|-4.3|0.8657
72526717|NCT03031327|144583838|SUPERIORITY||Mean Difference (Final Values)|-4.9||||0.044|TWO_SIDED|95.0|-9.7|-0.1|||ANOVA|||Analysis of variance on changes from baseline in ocular tolerability - Burning/Stinging - Non Study eye - Day 15±2||-0.1|-9.7|0.0440
72526718|NCT03031327|144583838|SUPERIORITY||Mean Difference (Final Values)|4.1||||0.1351|TWO_SIDED|95.0|-1.4|9.6|||ANOVA|||Analysis of variance on changes from baseline in ocular tolerability - Itching - Non Study eye - Day 15±2||9.6|-1.4|0.1351
72526719|NCT03031327|144583838|SUPERIORITY||Mean Difference (Final Values)|-0.4||||0.8821|TWO_SIDED|95.0|-6.0|5.2|||ANCOVA|||Analysis of variance on changes from baseline in ocular tolerability - Itching - Non Study eye - Day 15±2||5.2|-6.0|0.8821
72526720|NCT03031327|144583838|SUPERIORITY||Mean Difference (Final Values)|-4.5||||0.1208|TWO_SIDED|95.0|-10.3|1.3|||ANOVA|||Analysis of variance on changes from baseline in ocular tolerability - Itching - Non Study eye - Day 15±2||1.3|-10.3|0.1208
72526721|NCT03031327|144583838|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.944|TWO_SIDED|95.0|-3.3|3.5|||ANOVA|||Analysis of variance on changes from baseline in ocular tolerability - Pain - Non Study eye - Day 15±2||3.5|-3.3|0.9440
72526722|NCT03031327|144583838|SUPERIORITY||Mean Difference (Final Values)|1.1||||0.4903|TWO_SIDED|95.0|-2.2|4.5|||ANOVA|||Analysis of variance on changes from baseline in ocular tolerability - Pain - Non Study eye - Day 15±2||4.5|-2.2|0.4903
72526723|NCT03031327|144583838|SUPERIORITY||Mean Difference (Final Values)|1.0||||0.5364|TWO_SIDED|95.0|-2.3|4.3|||ANOVA|||Analysis of variance on changes from baseline in ocular tolerability - Pain - Non Study eye - Day 15±2||4.3|-2.3|0.5364
72526724|NCT03031327|144583838|SUPERIORITY||Mean Difference (Final Values)|1.4||||0.51|TWO_SIDED|95.0|-2.9|5.7|||ANOVA|||Analysis of variance on changes from baseline in ocular tolerability - Sticky feeling - Non Study eye - Day 15±2||5.7|-2.9|0.5100
72526725|NCT03031327|144583838|SUPERIORITY||Mean Difference (Final Values)|3.5||||0.1132|TWO_SIDED|95.0|-0.9|7.8|||ANOVA|||Analysis of variance on changes from baseline in ocular tolerability - Sticky feeling - Non Study eye - Day 15±2||7.8|-0.9|0.1132
72526726|NCT03031327|144583838|SUPERIORITY||Mean Difference (Final Values)|2.1||||0.3457|TWO_SIDED|95.0|-2.4|6.5|||ANOVA|||Analysis of variance on changes from baseline in ocular tolerability - Sticky feeling - Non Study eye - Day 15±2||6.5|-2.4|0.3457
72526727|NCT03031327|144583838|SUPERIORITY||Mean Difference (Final Values)|4.3||||0.0185|TWO_SIDED|95.0|0.8|7.9|||ANOVA|||Analysis of variance on changes from baseline in ocular tolerability - Blurred vision - Non Study eye - Day 15±2||7.9|0.8|0.0185
72526728|NCT03031327|144583838|SUPERIORITY||Mean Difference (Final Values)|3.6||||0.0408|TWO_SIDED|95.0|0.2|7.1|||ANOVA|||Analysis of variance on changes from baseline in ocular tolerability - Blurred vision - Non Study eye - Day 15±2||7.1|0.2|0.0408
72526729|NCT03031327|144583838|SUPERIORITY||Mean Difference (Final Values)|-0.7||||0.6992|TWO_SIDED|95.0|-4.4|3.0|||ANOVA|||Analysis of variance on changes from baseline in ocular tolerability - Blurred vision - Non Study eye - Day 15±2||3.0|-4.4|0.6992
72526730|NCT03031327|144583838|SUPERIORITY||Mean Difference (Final Values)|5.9||||0.0905|TWO_SIDED|95.0|-1.0|12.8|||ANOVA|||Analysis of variance on changes from baseline in ocular tolerability - Photophobia - Non Study eye - Day 15±2||12.8|-1.0|0.0905
72526731|NCT03031327|144583838|SUPERIORITY||Mean Difference (Final Values)|3.5||||0.3054|TWO_SIDED|95.0|-3.4|10.4|||ANOVA|||Analysis of variance on changes from baseline in ocular tolerability - Photophobia - Non Study eye - Day 15±2||10.4|-3.4|0.3054
72526732|NCT03031327|144583838|SUPERIORITY||Mean Difference (Final Values)|0.5024||||0.5024|TWO_SIDED|95.0|-9.6|4.8|||ANOVA|||Analysis of variance on changes from baseline in ocular tolerability - Photophobia - Non Study eye - Day 15±2||4.8|-9.6|0.5024
72526733|NCT03031327|144583840|SUPERIORITY||Mean Difference (Final Values)|0.4||||0.1226|TWO_SIDED|95.0|-0.1|0.8|||Student t-test pooled|Student t-test with pool method for estimating common variance on changes from baseline in ocular surface vital staining||Study eye - Day 15±2 pre-dose||0.8|-0.1|0.1226
72526734|NCT03031327|144583840|SUPERIORITY||Mean Difference (Final Values)|0.3||||0.2854|TWO_SIDED|95.0|-0.2|0.7|||Student t-test pooled|Student t-test with pool method for estimating common variance on changes from baseline in ocular surface vital staining||Study eye - Day 15±2 pre-dose||0.7|-0.2|0.2854
72526735|NCT03031327|144583840|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.6525|TWO_SIDED|95.0|-0.6|0.4|||Student t-test pooled|Student t-test pooled method for estimating common variance on changes from baseline in ocular surface vital staining -||Student t-test on changes from baseline in ocular surface vital staining - Study eye - Day 15±2 pre-dose||0.4|-0.6|0.6525
72526736|NCT03031327|144583840|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.8843|TWO_SIDED|95.0|-0.4|0.5|||Student t-test pooled|Student t-test pooled method for estimating common variance on changes from baseline in ocular surface vital staining -||Non Study eye - Day 15±2 pre-dose||0.5|-0.4|0.8843
72526737|NCT03031327|144583840|SUPERIORITY||Mean Difference (Final Values)|-0.3||||0.0806|TWO_SIDED|95.0|-0.6|0.0|||Student t-test pooled|Student t-test pooled method for estimating common variance on changes from baseline in ocular surface vital staining||Non Study eye - Day 15±2 pre-dose||0.0|-0.6|0.0806
72526738|NCT03031327|144583840|SUPERIORITY||Mean Difference (Final Values)|-0.3||||0.0628|TWO_SIDED|95.0|-0.7|0.0|||Student t-test pooled|Student t-test pooled method for estimating common variance on changes from baseline in ocular surface vital staining||Non Study eye - Day 15±2 pre-dose||0.0|-0.7|0.0628
72526739|NCT03031327|144583841|SUPERIORITY||Mean Difference (Final Values)|0.4||||0.2004|TWO_SIDED|95.0|-0.2|0.9|||Student t-test pooled|Pooled method for estimating common variance was used||Student t-test on changes from baseline in Schirmer-I test - Study eye - Day 15±2 pre-dose||0.9|-0.2|0.2004
72526740|NCT03031327|144583841|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.5413|TWO_SIDED|95.0|-0.3|0.6|||Student t-test pooled|Pooled method for estimating common variance was used||Student t-test on changes from baseline in Schirmer-I test - Study eye - Day 15±2 pre-dose||0.6|-0.3|0.5413
72526741|NCT03031327|144583841|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.4607|TWO_SIDED|95.0|-0.8|0.4|||Student t-test pooled|Pooled method for estimating common variance was used||Student t-test on changes from baseline in Schirmer-I test - Study eye - Day 15±2 pre-dose||0.4|-0.8|0.4607
72526742|NCT03031327|144583841|SUPERIORITY||Mean Difference (Final Values)|0.6||||0.1248|TWO_SIDED|95.0|-0.2|1.4|||Student t-test pooled|Pooled method for estimating common variance was used||Student t-test on changes from baseline in Schirmer-I test - Non Study eye - Day 15±2 pre-dose||1.4|-0.2|0.1248
72526743|NCT03031327|144583841|SUPERIORITY||Mean Difference (Final Values)|0.5||||0.0624|TWO_SIDED|95.0|0.0|1.1|||Student t-test pooled|Pooled method for estimating common variance was used||Student t-test on changes from baseline in Schirmer-I test - Non Study eye - Day 15±2 pre-dose||1.1|0.0|0.0624
72625313|NCT01098747|144780087|SUPERIORITY_OR_OTHER||Difference in proportion|-61.36|||<|0.001|TWO_SIDED|95.0|-75.21|-47.5||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||4 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-47.50|-75.21|<0.001
72625314|NCT01098747|144780087|SUPERIORITY_OR_OTHER||Difference in proportion|1.52||||0.668|TWO_SIDED|95.0|-5.47|8.52||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||4 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||8.52|-5.47|0.668
72526744|NCT03031327|144583841|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.7927|TWO_SIDED|95.0|-1.0|0.8|||Student t-test pooled|Pooled method for estimating common variance was used||Student t-test on changes from baseline in Schirmer-I test - Non Study eye - Day 15±2 pre-dose||0.8|-1.0|0.7927
72526745|NCT03031327|144583842|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.9717|TWO_SIDED|95.0|-0.6|0.7|||Student t-test pooled|Pooled method for estimating common variance was used||Student t-test on changes from baseline in TFBUT - Study eye - Day 15±2 pre-dose||0.7|-0.6|0.9717
72526746|NCT03031327|144583842|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.7386|TWO_SIDED|95.0|-0.6|0.9|||Student t-test pooled|Pooled method for estimating common variance was used||Study eye - Day 15±2 pre-dose||0.9|-0.6|0.7386
72526747|NCT03031327|144583842|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.7498|TWO_SIDED|95.0|-0.6|0.8|||Student t-test pooled|Pooled method for estimating common variance was used||Student t-test on changes from baseline in TFBUT - Study eye - Day 15±2 pre-dose||0.8|-0.6|0.7498
72526748|NCT03031327|144583842|SUPERIORITY||Mean Difference (Final Values)|-0.4||||0.3229|TWO_SIDED|95.0|-1.1|0.4|||Student t-test pooled|Pooled method for estimating common variance was used||Student t-test on changes from baseline in TFBUT - Non Study eye - Day 15±2 pre-dose||0.4|-1.1|0.3229
72625315|NCT01098747|144780087|SUPERIORITY_OR_OTHER||Difference in proportion|-60.31|||<|0.001|TWO_SIDED|95.0|-74.28|-46.34||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||5 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-46.34|-74.28|<0.001
72526749|NCT03031327|144583842|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.57|TWO_SIDED|95.0|-0.5|0.9|||Student t-test pooled|Pooled method for estimating common variance was used||Student t-test on changes from baseline in TFBUT - Non Study eye - Day 15±2 pre-dose||0.9|-0.5|0.5700
72526750|NCT03031327|144583842|SUPERIORITY||Mean Difference (Final Values)|0.6||||0.1197|TWO_SIDED|95.0|-0.2|1.3|||Student t-test pooled|Pooled method for estimating common variance was used||Student t-test on changes from baseline in TFBUT - Non Study eye - Day 15±2 pre-dose||1.3|-0.2|0.1197
72526751|NCT03031327|144583843|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.8787|TWO_SIDED|95.0|-0.6|0.6|||Student t-test pooled|||Student t-test on changes from baseline in BCDVA - Study eye - Day 15±2 pre-dose||0.6|-0.6|0.8787
72526752|NCT03031327|144583843|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.8159|TWO_SIDED|95.0|-0.5|0.7|||Student t-test pooled|||Student t-test on changes from baseline in BCDVA - Study eye - Day 15±2 pre-dose||0.7|-0.5|0.8159
72526753|NCT03031327|144583843|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.6525|TWO_SIDED|95.0|-0.4|0.6|||Student t-test pooled|||Student t-test on changes from baseline in BCDVA - Study eye - Day 15±2 pre-dose||0.6|-0.4|0.6525
72625316|NCT01098747|144780087|SUPERIORITY_OR_OTHER||Difference in proportion|1.1||||0.98|TWO_SIDED|95.0|-7.44|7.63||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||5 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||7.63|-7.44|0.980
72625317|NCT01098747|144780087|SUPERIORITY_OR_OTHER||Difference in proportion|-59.28|||<|0.001|TWO_SIDED|95.0|-73.05|-45.5||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||6 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-45.50|-73.05|<0.001
72625318|NCT01098747|144780087|SUPERIORITY_OR_OTHER||Difference in proportion|1.56||||0.711|TWO_SIDED|95.0|-6.68|9.81||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||6 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||9.81|-6.68|0.711
72625319|NCT01098747|144780087|SUPERIORITY_OR_OTHER||Difference in proportion|-56.84|||<|0.001|TWO_SIDED|95.0|-70.84|-42.85||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||7 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-42.85|-70.84|<0.001
72526754|NCT03031327|144583843|SUPERIORITY||Mean Difference (Final Values)|-0.3||||0.334|TWO_SIDED|95.0|-1.0|0.4|||Student t-test pooled|||Student t-test on changes from baseline in BCDVA - Non Study eye - Day 15±2 pre-dose||0.4|-1.0|0.3340
72526755|NCT03031327|144583843|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.9749|TWO_SIDED|95.0|-0.7|0.7|||Student t-test pooled|||Student t-test on changes from baseline in BCDVA - Non Study eye - Day 15±2 pre-dose||0.7|-0.7|0.9749
72526756|NCT03031327|144583843|SUPERIORITY||Mean Difference (Final Values)|0.3||||0.1984|TWO_SIDED|95.0|-0.2|0.9|||Student t-test pooled|||Student t-test on changes from baseline in BCDVA - Non Study eye - Day 15±2 pre-dose||0.9|-0.2|0.1984
72526757|NCT03031327|144583844|SUPERIORITY||Mean Difference (Final Values)|3.0||||0.6497|TWO_SIDED|95.0|-10.5|16.4|||Student t-test pooled|Pooled method for estimating common variance was used||Student t-test on changes from baseline in SANDE scores - Frequency of symptoms - Day 15±2 pre-dose||16.4|-10.5|0.6497
72526758|NCT03031327|144583844|SUPERIORITY||Mean Difference (Final Values)|-6.9||||0.1443|TWO_SIDED|95.0|-16.5|2.6|||Student t-test pooled|Pooled method for estimating common variance was used||Student t-test on changes from baseline in SANDE scores - Frequency of symptoms - Day 15±2 pre-dose||2.6|-16.5|0.1443
72526759|NCT03031327|144583844|SUPERIORITY||Mean Difference (Final Values)|-9.9||||0.0751|TWO_SIDED|95.0|-20.9|1.1|||Student t-test pooled|Pooled method for estimating common variance was used||Student t-test on changes from baseline in SANDE scores - Frequency of symptoms - Day 15±2 pre-dose||1.1|-20.9|0.0751
72526760|NCT03031327|144583844|SUPERIORITY||Mean Difference (Final Values)|3.8||||0.5015|TWO_SIDED|95.0|-7.9|15.5|||Student t-test pooled|Pooled method for estimating common variance was used||Student t-test on changes from baseline in SANDE scores - Severity of symptoms - Day 15±2 pre-dose||15.5|-7.9|0.5015
72526761|NCT03031327|144583844|SUPERIORITY||Mean Difference (Final Values)|-4.1||||0.3217|TWO_SIDED|95.0|-12.5|4.4|||Student t-test pooled|Pooled method for estimating common variance was used||Student t-test on changes from baseline in SANDE scores - Severity of symptoms - Day 15±2 pre-dose||4.4|-12.5|0.3217
72526762|NCT03031327|144583844|SUPERIORITY||Mean Difference (Final Values)|-7.9||||0.1026|TWO_SIDED|95.0|-17.5|1.8|||Student t-test pooled|Pooled method for estimating common variance was used||Student t-test on changes from baseline in SANDE scores - Severity of symptoms - Day 15±2 pre-dose||1.8|-17.5|0.1026
72526763|NCT03031327|144583845|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Eyelid - Meibomian Glands - Study eye - Day 15±2 pre-dose||||1.000
72526764|NCT03031327|144583845|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Eyelid - Meibomian Glands - Study eye - Day 15±2 pre-dose||||1.000
72526765|NCT03031327|144583845|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Eyelid - Meibomian Glands - Study eye - Day 15±2 pre-dose||||1.000
72526766|NCT03031327|144583845|SUPERIORITY|||||||0.4101|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Eyelid - Meibomian Glands - Non Study eye - Day 15±2 pre-dose||||0.4101
72526767|NCT03031327|144583845|SUPERIORITY|||||||0.4101|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Eyelid - Meibomian Glands - Non Study eye - Day 15±2 pre-dose||||0.4101
72526768|NCT03031327|144583845|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Eyelid - Meibomian Glands - Non Study eye - Day 15±2 pre-dose||||1.000
72526769|NCT03031327|144583845|SUPERIORITY|||||||0.4101|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Eyelid - Erythema - Study eye - Day 15±2 pre-dose||||0.4101
72526770|NCT03031327|144583845|SUPERIORITY|||||||0.4101|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Eyelid - Erythema - Study eye - Day 15±2 pre-dose||||0.4101
72526771|NCT03031327|144583845|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Eyelid - Erythema - Study eye - Day 15±2 pre-dose||||1.000
72526772|NCT03031327|144583845|SUPERIORITY|||||||0.4101|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Eyelid - Erythema - Non Study eye - Day 15±2 pre-dose||||0.4101
72526773|NCT03031327|144583845|SUPERIORITY|||||||0.4101|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Eyelid - Erythema - Non Study eye - Day 15±2 pre-dose||||0.4101
72526774|NCT03031327|144583845|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Eyelid - Erythema - Non Study eye - Day 15±2 pre-dose||||1.000
72625320|NCT01098747|144780087|SUPERIORITY_OR_OTHER||Difference in proportion|3.72||||0.445|TWO_SIDED|95.0|-5.94|13.38||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||7 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||13.38|-5.94|0.445
72407122|NCT02477020|144322865|SUPERIORITY_OR_OTHER||Least square mean difference|-0.37|STANDARD_ERROR_OF_MEAN|1.625||0.821|TWO_SIDED|95.0|-3.58|2.84||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. PANSS subscale score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction and Baseline PANSS subscale score-by-week interaction.|PANSS General Score, Change at Week 4||2.84|-3.58|0.821
72526775|NCT03031327|144583845|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Eyelid - Oedema - Study eye - Day 15±2 pre-dose||||1.000
72526776|NCT03031327|144583845|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Eyelid - Oedema - Study eye - Day 15±2 pre-dose||||1.000
72526777|NCT03031327|144583845|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Eyelid - Oedema - Study eye - Day 15±2 pre-dose||||1.000
72526778|NCT03031327|144583845|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Eyelid - Oedema - Non Study eye - Day 15±2 pre-dose||||1.000
72526779|NCT03031327|144583845|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Eyelid - Oedema - Non Study eye - Day 15±2 pre-dose||||1.000
72526780|NCT03031327|144583845|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Eyelid - Oedema - Non Study eye - Day 15±2 pre-dose||||1.000
72526781|NCT03031327|144583845|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Lashes - Study eye - Day 15±2 pre-dose||||1.000
72526782|NCT03031327|144583845|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Lashes - Study eye - Day 15±2 pre-dose||||1.000
72526783|NCT03031327|144583845|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Lashes - Study eye - Day 15±2 pre-dose||||1.000
72526784|NCT03031327|144583845|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Lashes - Non Study eye - Day 15±2 pre-dose||||1.000
72526785|NCT03031327|144583845|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Lashes - Non Study eye - Day 15±2 pre-dose||||1.000
72526786|NCT03031327|144583845|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Lashes - Non Study eye - Day 15±2 pre-dose||||1.000
72526787|NCT03031327|144583845|SUPERIORITY|||||||0.5267|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Conjunctiva - Erythema - Study eye - Day 15±2 pre-dose||||0.5267
72526788|NCT03031327|144583845|SUPERIORITY|||||||0.2633|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Conjunctiva - Erythema - Study eye - Day 15±2 pre-dose||||0.2633
72526789|NCT03031327|144583845|SUPERIORITY|||||||0.6552|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Conjunctiva - Erythema - Study eye - Day 15±2 pre-dose||||0.6552
72526790|NCT03031327|144583845|SUPERIORITY|||||||0.1262|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Conjunctiva - Erythema - Non Study eye - Day 15±2 pre-dose||||0.1262
72526791|NCT03031327|144583845|SUPERIORITY|||||||0.2094|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Conjunctiva - Erythema - Non Study eye - Day 15±2 pre-dose||||0.2094
72526792|NCT03031327|144583845|SUPERIORITY||Hodges Lehmann estimation|-1.0||||0.0377|TWO_SIDED|95.0|-1.0|0.0|||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Conjunctiva - Erythema - Non Study eye - Day 15±2 pre-dose||0.0|-1.0|0.0377
72526793|NCT03031327|144583845|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Conjunctiva - Oedema - Study eye - Day 15±2 pre-dose||||1.000
72526794|NCT03031327|144583845|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Conjunctiva - Oedema - Study eye - Day 15±2 pre-dose||||1.000
72526795|NCT03031327|144583845|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Conjunctiva - Oedema - Study eye - Day 15±2 pre-dose||||1.000
72526796|NCT03031327|144583845|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Conjunctiva - Oedema - Non Study eye - Day 15±2 pre-dose||||1.000
72526797|NCT03031327|144583845|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Conjunctiva - Oedema - Non Study eye - Day 15±2 pre-dose||||1.000
72526798|NCT03031327|144583845|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Conjunctiva - Oedema - Non Study eye - Day 15±2 pre-dose||||1.000
72526799|NCT03031327|144583845|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Lens - Study eye - Day 15±2 pre-dose||||1.000
72526800|NCT03031327|144583845|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Lens - Study eye - Day 15±2 pre-dose||||1.000
72526801|NCT03031327|144583845|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Lens - Study eye - Day 15±2 pre-dose||||1.000
72526802|NCT03031327|144583845|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Lens - Non Study eye - Day 15±2 pre-dose||||1.000
72526803|NCT03031327|144583845|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Lens - Non Study eye - Day 15±2 pre-dose||||1.000
72526804|NCT03031327|144583845|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Lens - Non Study eye - Day 15±2 pre-dose||||1.000
72526805|NCT03031327|144583845|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Iris - Study eye - Day 15±2 pre-dose||||1.000
72526806|NCT03031327|144583845|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Iris - Study eye - Day 15±2 pre-dose||||1.000
72526807|NCT03031327|144583845|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Iris - Study eye - Day 15±2 pre-dose||||1.000
72526808|NCT03031327|144583845|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Iris - Non Study eye - Day 15±2 pre-dose||||1.000
72526809|NCT03031327|144583845|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Iris - Non Study eye - Day 15±2 pre-dose||||1.000
72526810|NCT03031327|144583845|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Iris - Non Study eye - Day 15±2 pre-dose||||1.000
72526811|NCT03031327|144583845|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Anterior chamber inflammation - Study eye - Day 15±2 pre-dose||||1.000
72526812|NCT03031327|144583845|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Anterior chamber inflammation - Study eye - Day 15±2 pre-dose||||1.000
72526813|NCT03031327|144583845|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Anterior chamber inflammation - Study eye - Day 15±2 pre-dose||||1.000
72526814|NCT03031327|144583845|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Anterior chamber inflammation - Non Study eye - Day 15±2 pre-dose||||1.000
72526815|NCT03031327|144583845|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Anterior chamber inflammation - Non Study eye - Day 15±2 pre-dose||||1.000
72526816|NCT03031327|144583845|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Anterior chamber inflammation - Non Study eye - Day 15±2 pre-dose||||1.000
72526817|NCT03031327|144583845|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Cornea transparency - Study eye - Day 15±2 pre-dose||||1.000
72526818|NCT03031327|144583845|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Cornea transparency - Study eye - Day 15±2 pre-dose||||1.000
72526819|NCT03031327|144583845|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Cornea transparency - Study eye - Day 15±2 pre-dose||||1.000
72526820|NCT03031327|144583845|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Cornea transparency - Non Study eye - Day 15±2 pre-dose||||1.000
72526821|NCT03031327|144583845|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Cornea transparency - Non Study eye - Day 15±2 pre-dose||||1.000
72526822|NCT03031327|144583845|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Cornea transparency - Non Study eye - Day 15±2 pre-dose||||1.000
72526823|NCT03031327|144583845|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Cornea neovascularization - Study eye - Day 15±2 pre-dose||||1.000
72526824|NCT03031327|144583845|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Cornea neovascularization - Study eye - Day 15±2 pre-dose||||1.000
72526825|NCT03031327|144583845|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Cornea neovascularization - Study eye - Day 15±2 pre-dose||||1.000
72526826|NCT03031327|144583845|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Cornea neovascularization - Non Study eye - Day 15±2 pre-dose||||1.000
72526827|NCT03031327|144583845|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Cornea neovascularization - Non Study eye - Day 15±2 pre-dose||||1.000
72526828|NCT03031327|144583845|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Cornea neovascularization - Non Study eye - Day 15±2 pre-dose||||1.000
72526829|NCT03031327|144583846|SUPERIORITY||Mean Difference (Final Values)|0.5||||0.5842|TWO_SIDED|95.0|-1.5|2.6|||Student t-test pooled|Pooled method for estimating common variance was used||Student t-test on changes from baseline in IOP - Study eye - Day 15±2 pre-dose||2.6|-1.5|0.5842
72526830|NCT03031327|144583846|SUPERIORITY||Mean Difference (Final Values)|-0.6||||0.4606|TWO_SIDED|95.0|-2.2|1.0|||Student t-test pooled|Pooled method for estimating common variance was used||Student t-test on changes from baseline in IOP - Study eye - Day 15±2 pre-dose||1.0|-2.2|0.4606
72526831|NCT03031327|144583846|SUPERIORITY||Mean Difference (Final Values)|-1.1||||0.2319|TWO_SIDED|95.0|-3.0|0.8|||Student t-test pooled|Pooled method for estimating common variance was used||Student t-test on changes from baseline in IOP - Study eye - Day 15±2 pre-dose||0.8|-3.0|0.2319
72526832|NCT03031327|144583846|SUPERIORITY||Mean Difference (Final Values)|-0.5||||0.6018|TWO_SIDED|95.0|-2.3|1.4|||Student t-test pooled|Pooled method for estimating common variance was used||Student t-test on changes from baseline in IOP - Non Study eye - Day 15±2 pre-dose||1.4|-2.3|0.6018
72407123|NCT02477020|144322865|SUPERIORITY_OR_OTHER||Least square mean difference|-1.61|STANDARD_ERROR_OF_MEAN|1.621||0.323|TWO_SIDED|95.0|-4.81|1.6||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. PANSS subscale score as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction and Baseline PANSS subscale score-by-week interaction.|PANSS General Score, Change at Week 5||1.60|-4.81|0.323
72407124|NCT02477020|144322865|SUPERIORITY_OR_OTHER||Least square mean difference|-2.44|STANDARD_ERROR_OF_MEAN|1.732||0.161|TWO_SIDED|95.0|-5.87|0.98||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. PANSS subscale score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction and Baseline PANSS subscale score-by-week interaction.|PANSS General Score, Change at Week 6||0.98|-5.87|0.161
72526833|NCT03031327|144583846|SUPERIORITY||Mean Difference (Final Values)|-0.6||||0.4857|TWO_SIDED|95.0|-2.2|1.1|||Student t-test pooled|Pooled method for estimating common variance was used||Student t-test on changes from baseline in IOP - Non Study eye - Day 15±2 pre-dose||1.1|-2.2|0.4857
72526834|NCT03031327|144583846|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.9015|TWO_SIDED|95.0|-2.0|1.8|||Student t-test pooled|Pooled method for estimating common variance was used||Student t-test on changes from baseline in IOP - Non Study eye - Day 15±2 pre-dose||1.8|-2.0|0.9015
72526835|NCT03031327|144583847|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.3574|TWO_SIDED|95.0|-0.1|0.3|||Student t-test pooled|Pooled method for estimating common variance was used||Student t-test on changes from baseline in corneal sensitivity - Study eye - Day 15±2 pre-dose||0.3|-0.1|0.3574
72526836|NCT03031327|144583847|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.3574|TWO_SIDED|95.0|-0.1|0.3|||Student t-test pooled|Pooled method for estimating common variance was used||Student t-test on changes from baseline in corneal sensitivity - Study eye - Day 15±2 pre-dose||0.3|-0.1|0.3574
72526837|NCT03031327|144583847|SUPERIORITY||Mean Difference (Final Values)|0.0||||0|TWO_SIDED|95.0|0.0|0.0||P-value is NA due to the measured values of corneal sensitivity equal to zero.|Student t-test pooled|Pooled method for estimating common variance was used||Student t-test on changes from baseline in corneal sensitivity - Study eye - Day 15±2 pre-dose||0.0|0.0|00
72526838|NCT03031327|144583847|SUPERIORITY||Mean Difference (Final Values)|0.0||||0|TWO_SIDED|95.0|0.0|0.0||P-value is NA due to the measured values of corneal sensitivity equal to zero.|Student t-test pooled|Pooled method for estimating common variance was used||Student t-test on changes from baseline in corneal sensitivity - Non Study eye - Day 15±2 pre-dose||0.0|0.0|00
72526839|NCT03031327|144583847|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.1|TWO_SIDED|95.0|-0.1|0.3|||Student t-test pooled|Pooled method for estimating common variance was used||Student t-test on changes from baseline in corneal sensitivity - Non Study eye - Day 15±2 pre-dose||0.3|-0.1|0.1
72407125|NCT02477020|144322866|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.664||||0.017|TWO_SIDED|95.0|1.263|10.624|||Regression, Logistic||TAK-063 versus Placebo. The p-values were obtained using a logistic regression model adjusting for treatment and the Baseline PANSS total score.|Week 1||10.624|1.263|0.017
72526840|NCT03031327|144583847|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.1|TWO_SIDED|95.0|-0.1|0.3|||Student t-test pooled|Pooled method for estimating common variance was used||Student t-test on changes from baseline in corneal sensitivity - Non Study eye - Day 15±2 pre-dose||0.3|-0.1|0.1
72526841|NCT04806165|144583873|SUPERIORITY|To improve the quality of the imputations, gender, age, and race were included as auxiliary variables. We generated ten imputed datasets with the predictive mean matching method and pooled coefficients, degrees of freedom, and standard errors with Rubin's (1987) rules. As a sensitivity analysis, we also ran the same models using full information maximum likelihood to handle missing data. The model was estimated using a logit link and did not incorporate an intercept.|Regression (Beta) Coefficient|-0.26|STANDARD_ERROR_OF_MEAN|0.26||0.309|TWO_SIDED|||||We defined sufficiently large main effects as those with p values ≤ .05 or with 95% confidence intervals that do not include 0. We interpreted absolute ß values below 0.2 as small, between 0.2 and 0.5 as medium, and greater than 0.5 as large.|Discrete Time Survival Analysis|The model did not incorporate an intercept to allow for estimation of treatment receipt likelihood among participants yet to report treatment.||This analysis explores the effect of the motivational interviewing (MI) component on rates of treatment receipt over the entire study period. Results will help determine the proportional increase in odds of treatment seeking corresponding to receiving each chatbot component. Discrete time survival analysis was employed and models were fit with treatment seeking regressed on follow-up time (2-week, 6-week, or 14-week) and each chatbot component.||||.309
72526842|NCT04806165|144583873|SUPERIORITY|To improve the quality of the imputations, gender, age, and race were included as auxiliary variables. We generated ten imputed datasets with the predictive mean matching method and pooled coefficients, degrees of freedom, and standard errors with Rubin's (1987) rules. As a sensitivity analysis, we also ran the same models using full information maximum likelihood to handle missing data. The model was estimated using a logit link and did not incorporate an intercept.|Regression (Beta) Coefficient|0.34|STANDARD_ERROR_OF_MEAN|0.26||0.19|TWO_SIDED|||||We defined sufficiently large main effects as those with p values ≤ .05 or with 95% confidence intervals that do not include 0. We interpreted absolute ß values below 0.2 as small, between 0.2 and 0.5 as medium, and greater than 0.5 as large.|Discrete Time Survival Analysis|The model did not incorporate an intercept to allow for estimation of treatment receipt likelihood among participants yet to report treatment.||This analysis explores the effect of the personalized recommendation (PR) component on rates of treatment receipt over the entire study period. Results will help determine the proportional increase in odds of treatment seeking corresponding to receiving each chatbot component. Discrete time survival analysis was employed and models were fit with treatment seeking regressed on follow-up time (2-week, 6-week, or 14-week) and each chatbot component.||||.190
72571352|NCT04709835|144671327|SUPERIORITY||Difference in Percentage of Positivity|-0.26|||||TWO_SIDED|80.0|-13.39|12.88|||||Confidence interval estimated with the Farrington-Manning method.|Day 7||12.88|-13.39|
72407126|NCT02477020|144322866|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.782||||0.009|TWO_SIDED|95.0|1.287|6.014|||Regression, Logistic||TAK-063 versus Placebo. The p-values were obtained using a logistic regression model adjusting for treatment and the Baseline PANSS total score.|Week 2||6.014|1.287|0.009
72526843|NCT04806165|144583873|SUPERIORITY|To improve the quality of the imputations, gender, age, and race were included as auxiliary variables. We generated ten imputed datasets with the predictive mean matching method and pooled coefficients, degrees of freedom, and standard errors with Rubin's (1987) rules. As a sensitivity analysis, we also ran the same models using full information maximum likelihood to handle missing data. The model was estimated using a logit link and did not incorporate an intercept.|Regression (Beta) Coefficient|-0.1|STANDARD_ERROR_OF_MEAN|0.26||0.69|TWO_SIDED|||||We defined sufficiently large main effects as those with p values ≤ .05 or with 95% confidence intervals that do not include 0. We interpreted absolute ß values below 0.2 as small, between 0.2 and 0.5 as medium, and greater than 0.5 as large.|Discrete Time Survival Analysis|The model did not incorporate an intercept to allow for estimation of treatment receipt likelihood among participants yet to report treatment.||This analysis explores the effect of the psychoeducation (PE) component on rates of treatment receipt over the entire study period. Results will help determine the proportional increase in odds of treatment seeking corresponding to receiving each chatbot component. Discrete time survival analysis was employed and models were fit with treatment seeking regressed on follow-up time (2-week, 6-week, or 14-week) and each chatbot component.||||.690
72526844|NCT04806165|144583873|SUPERIORITY|To improve the quality of the imputations, gender, age, and race were included as auxiliary variables. We generated ten imputed datasets with the predictive mean matching method and pooled coefficients, degrees of freedom, and standard errors with Rubin's (1987) rules. As a sensitivity analysis, we also ran the same models using full information maximum likelihood to handle missing data. The model was estimated using a logit link and did not incorporate an intercept.|Regression (Beta) Coefficient|0.54|STANDARD_ERROR_OF_MEAN|0.26||0.038|TWO_SIDED|||||We defined sufficiently large main effects as those with p values ≤ .05 or with 95% confidence intervals that do not include 0. We interpreted absolute ß values below 0.2 as small, between 0.2 and 0.5 as medium, and greater than 0.5 as large.|Discrete Time Survival Analysis|The model did not incorporate an intercept to allow for estimation of treatment receipt likelihood among participants yet to report treatment.||This analysis explores the effect of the repeated administration (RA) component on rates of treatment receipt over the entire study period. Results will help determine the proportional increase in odds of treatment seeking corresponding to receiving each chatbot component. Discrete time survival analysis was employed and models were fit with treatment seeking regressed on follow-up time (2-week, 6-week, or 14-week) and each chatbot component.||||0.038
72526845|NCT04806165|144583873|SUPERIORITY|To improve the quality of the imputations, gender, age, and race were included as auxiliary variables. We generated ten imputed datasets with the predictive mean matching method and pooled coefficients, degrees of freedom, and standard errors with Rubin's (1987) rules. As a sensitivity analysis, we also ran the same models using full information maximum likelihood to handle missing data. The model was estimated using a logit link and did not incorporate an intercept.|Regression (Beta) Coefficient|0.06|STANDARD_ERROR_OF_MEAN|0.16||0.735|TWO_SIDED|||||We defined sufficiently large main effects as those with p values ≤ .05 or with 95% confidence intervals that do not include 0. We interpreted absolute ß values below 0.2 as small, between 0.2 and 0.5 as medium, and greater than 0.5 as large.|Discrete Time Survival Analysis|The model did not incorporate an intercept to allow for estimation of treatment receipt likelihood among participants yet to report treatment.||This analysis provides results on the 2 week time point post Intervention and contributes to understanding of the effect of time since chatbot engagement on treatment receipt, regardless of the combination of the four chatbot components participants were assigned (ie., component turned off or on). Discrete time survival analysis was employed and models were fit with treatment seeking regressed on follow-up time (2-week, 6-week, or 14-week) and each chatbot component.||||.735
72526846|NCT04806165|144583873|SUPERIORITY|To improve the quality of the imputations, gender, age, and race were included as auxiliary variables. We generated ten imputed datasets with the predictive mean matching method and pooled coefficients, degrees of freedom, and standard errors with Rubin's (1987) rules. As a sensitivity analysis, we also ran the same models using full information maximum likelihood to handle missing data. The model was estimated using a logit link and did not incorporate an intercept.|Regression (Beta) Coefficient|-0.91|STANDARD_ERROR_OF_MEAN|0.27||0.001|TWO_SIDED|||||We defined sufficiently large main effects as those with p values ≤ .05 or with 95% confidence intervals that do not include 0. We interpreted absolute ß values below 0.2 as small, between 0.2 and 0.5 as medium, and greater than 0.5 as large.|Discrete Time Survival Analysis|The model did not incorporate an intercept to allow for estimation of treatment receipt likelihood among participants yet to report treatment.||This analysis provides results on the 6 week time point post Intervention and contributes to understanding of the effect of time since chatbot engagement on treatment receipt, regardless of the combination of the four chatbot components participants were assigned (ie., component turned off or on). Discrete time survival analysis was employed and models were fit with treatment seeking regressed on follow-up time (2-week, 6-week, or 14-week) and each chatbot component.||||.001
72526847|NCT04806165|144583873|SUPERIORITY|To improve the quality of the imputations, gender, age, and race were included as auxiliary variables. We generated ten imputed datasets with the predictive mean matching method and pooled coefficients, degrees of freedom, and standard errors with Rubin's (1987) rules. As a sensitivity analysis, we also ran the same models using full information maximum likelihood to handle missing data. The model was estimated using a logit link and did not incorporate an intercept.|Regression (Beta) Coefficient|-0.73|STANDARD_ERROR_OF_MEAN|0.3||0.014|TWO_SIDED|||||We defined sufficiently large main effects as those with p values ≤ .05 or with 95% confidence intervals that do not include 0. We interpreted absolute ß values below 0.2 as small, between 0.2 and 0.5 as medium, and greater than 0.5 as large.|Discrete Time Survival Analysis|The model did not incorporate an intercept to allow for estimation of treatment receipt likelihood among participants yet to report treatment.||This analysis provides results on the 14 week time point post Intervention and contributes to understanding of the effect of time since chatbot engagement on treatment receipt, regardless of the combination of the four chatbot components participants were assigned (ie., component turned off or on). Discrete time survival analysis was employed and models were fit with treatment seeking regressed on follow-up time (2-week, 6-week, or 14-week) and each chatbot component.||||.014
72571353|NCT04709835|144671339|SUPERIORITY||Difference in Adjusted Means|-0.1|STANDARD_ERROR_OF_MEAN|0.294||0.7351|TWO_SIDED|80.0|-0.48|0.28|||ANCOVA||A difference in adjusted means of \<0 favors RO7496998 (AT-527).|Day 3||0.28|-0.48|0.7351
72407127|NCT02477020|144322866|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.818||||0.108|TWO_SIDED|95.0|0.877|3.771|||Regression, Logistic||TAK-063 versus Placebo. The p-values were obtained using a logistic regression model adjusting for treatment and the Baseline PANSS total score.|Week 3||3.771|0.877|0.108
72526848|NCT04806165|144583874|SUPERIORITY|Gender, age, and race were included as auxiliary variables to improve imputation quality. We generated ten imputed datasets with the predictive mean matching method and pooled coefficients, degrees of freedom, and standard errors with Rubin's (1987) rules. For sensitivity analysis, models were run again using full information maximum likelihood to handle missing data.|Regression (Beta) Coefficient|0.53||||0.25|TWO_SIDED|||||"We interpreted absolute ß values below 0.2 as small, between 0.2 and 0.5 as medium, and greater than 0.5 as large.~We defined sufficiently large main effects as those with p values ≤ .05 or with 95% confidence intervals that do not include 0."|Linear Mixed Effects Model|||Analyses were conducted to determine the effects of each of the four chatbot components on secondary outcomes. This analysis in particular explores the effects of the motivational interviewing component (MI) on participant willingness to seek psychotherapy for concerns their disordered weight and shape behaviors and thoughts since engagement with the intervention. Linear mixed effects models incorporated a random intercept to accommodate the correlation of repeated measures within participants.||||0.25
72526849|NCT04806165|144583874|SUPERIORITY|To improve the quality of the imputations, gender, age, and race were included as auxiliary variables. We generated ten imputed datasets with the predictive mean matching method and pooled coefficients, degrees of freedom, and standard errors with Rubin's (1987) rules. As a sensitivity analysis, we also ran the same models using full information maximum likelihood to handle missing data.|Regression (Beta) Coefficient|-0.36||||0.44|TWO_SIDED|||||"We interpreted absolute ß values below 0.2 as small, between 0.2 and 0.5 as medium, and greater than 0.5 as large.~We defined sufficiently large main effects as those with p values ≤ .05 or with 95% confidence intervals that do not include 0."|Linear Mixed Effects Model|The linear mixed effects models incorporated a random intercept to accommodate the correlation of repeated measures within participants.||Analyses were conducted to determine the effects of each of the four chatbot components on willingness to seek psychotherapy. This analysis in particular explores the effects of the psychoeducation component (PE) on participant willingness to seek psychotherapy for concerns related to their eating, weight, and/or shape concerns since engagement with the intervention.||||0.44
72526850|NCT04806165|144583874|SUPERIORITY|To improve the quality of the imputations, gender, age, and race were included as auxiliary variables. We generated ten imputed datasets with the predictive mean matching method and pooled coefficients, degrees of freedom, and standard errors with Rubin's (1987) rules. As a sensitivity analysis, we also ran the same models using full information maximum likelihood to handle missing data.|Regression (Beta) Coefficient|-0.25||||0.44|TWO_SIDED|||||"We interpreted absolute ß values below 0.2 as small, between 0.2 and 0.5 as medium, and greater than 0.5 as large.~We defined sufficiently large main effects as those with p values ≤ .05 or with 95% confidence intervals that do not include 0."|Linear Mixed Effects Model|The linear mixed effects models incorporated a random intercept to accommodate the correlation of repeated measures within participants.||Analyses were conducted to determine the effects of each of the four chatbot components on willingness to seek psychotherapy. This analysis in particular explores the effects of the personalized recommendation component (PR) on participant willingness to seek psychotherapy for concerns related to their eating, weight, and/or shape concerns since engagement with the intervention.||||0.44
72526851|NCT04806165|144583874|SUPERIORITY|To improve the quality of the imputations, gender, age, and race were included as auxiliary variables. We generated ten imputed datasets with the predictive mean matching method and pooled coefficients, degrees of freedom, and standard errors with Rubin's (1987) rules. As a sensitivity analysis, we also ran the same models using full information maximum likelihood to handle missing data.|Regression (Beta) Coefficient|0.29||||0.53|TWO_SIDED|||||"We interpreted absolute ß values below 0.2 as small, between 0.2 and 0.5 as medium, and greater than 0.5 as large.~We defined sufficiently large main effects as those with p values ≤ .05 or with 95% confidence intervals that do not include 0."|Linear Mixed Effects Model|The linear mixed effects models incorporated a random intercept to accommodate the correlation of repeated measures within participants.||Analyses were conducted to determine the effects of each of the four chatbot components on willingness to seek psychotherapy. This analysis in particular explores the effects of the repeated administration component (RA) on participant willingness to seek psychotherapy for concerns related to their eating, weight, and/or shape concerns since engagement with the intervention.||||0.53
72526852|NCT04806165|144583874|SUPERIORITY|To improve the quality of the imputations, gender, age, and race were included as auxiliary variables. We generated ten imputed datasets with the predictive mean matching method and pooled coefficients, degrees of freedom, and standard errors with Rubin's (1987) rules. As a sensitivity analysis, we also ran the same models using full information maximum likelihood to handle missing data.|Regression (Beta) Coefficient|-0.53||||0.07|TWO_SIDED|||||"We interpreted absolute ß values below 0.2 as small, between 0.2 and 0.5 as medium, and greater than 0.5 as large.~We defined sufficiently large main effects as those with p values ≤ .05 or with 95% confidence intervals that do not include 0."|Linear Mixed Effects Model|The linear mixed effects models incorporated a random intercept to accommodate the correlation of repeated measures within participants.||This analysis provides results on the 2 week time point post Intervention and contributes to understanding of the effect of time since chatbot engagement on willingness to seek psychotherapy, regardless of the combination of the four chatbot components participants were assigned (ie., component turned off or on).||||0.07
72571354|NCT04709835|144671339|SUPERIORITY||Difference in Adjusted Means|-0.1|STANDARD_ERROR_OF_MEAN|0.31||0.7524|TWO_SIDED|80.0|-0.5|0.3|||ANCOVA||A difference in adjusted means of \<0 favors RO7496998 (AT-527).|Day 5||0.30|-0.50|0.7524
72571355|NCT04709835|144671339|SUPERIORITY||Difference in Adjusted Means|-0.08|STANDARD_ERROR_OF_MEAN|0.314||0.8083|TWO_SIDED|80.0|-0.48|0.33|||ANCOVA||A difference in adjusted means of \<0 favors RO7496998 (AT-527).|Day 7||0.33|-0.48|0.8083
72571356|NCT04711902|144671356|OTHER|estimation and confidence interval|Marginal difference|39.91|||||TWO_SIDED|95.0|10.87|68.95|||Regression, Logistic|||||68.95|10.87|
72571357|NCT04711902|144671357|OTHER|estimation and confidence interval|Marginal difference|11.86|||||TWO_SIDED|95.0|-7.18|30.91|||Regression, Logistic|||||30.91|-7.18|
72571358|NCT04711902|144671358|OTHER|estimation and confidence interval|Mixed model repeated measures (MMRM)|-1.1|||||TWO_SIDED|95.0|-1.68|-0.52|||Mixed Models Analysis|||||-0.52|-1.68|
72407128|NCT02477020|144322866|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.222||||0.596|TWO_SIDED|95.0|0.583|2.561|||Regression, Logistic||TAK-063 versus Placebo. The p-values were obtained using a logistic regression model adjusting for treatment and the Baseline PANSS total score.|Week 4||2.561|0.583|0.596
72526853|NCT04806165|144583874|SUPERIORITY|To improve the quality of the imputations, gender, age, and race were included as auxiliary variables. We generated ten imputed datasets with the predictive mean matching method and pooled coefficients, degrees of freedom, and standard errors with Rubin's (1987) rules. As a sensitivity analysis, we also ran the same models using full information maximum likelihood to handle missing data.|Regression (Beta) Coefficient|-1.06||||0.01|TWO_SIDED|||||"We interpreted absolute ß values below 0.2 as small, between 0.2 and 0.5 as medium, and greater than 0.5 as large.~We defined sufficiently large main effects as those with p values ≤ .05 or with 95% confidence intervals that do not include 0."|Linear Mixed Effects Model|The linear mixed effects models incorporated a random intercept to accommodate the correlation of repeated measures within participants.||This analysis provides results on the 6 week time point post Intervention and contributes to understanding of the effect of time since chatbot engagement on willingness to seek psychotherapy, regardless of the combination of the four chatbot components participants were assigned (ie., component turned off or on).||||0.01
72526854|NCT04806165|144583874|SUPERIORITY|To improve the quality of the imputations, gender, age, and race were included as auxiliary variables. We generated ten imputed datasets with the predictive mean matching method and pooled coefficients, degrees of freedom, and standard errors with Rubin's (1987) rules. As a sensitivity analysis, we also ran the same models using full information maximum likelihood to handle missing data.|Regression (Beta) Coefficient|-0.85||||0.042|TWO_SIDED|||||"We interpreted absolute ß values below 0.2 as small, between 0.2 and 0.5 as medium, and greater than 0.5 as large.~We defined sufficiently large main effects as those with p values ≤ .05 or with 95% confidence intervals that do not include 0."|Linear Mixed Effects Model|The linear mixed effects models incorporated a random intercept to accommodate the correlation of repeated measures within participants.||This analysis provides results on the 14 week time point post Intervention and contributes to understanding of the effect of time since chatbot engagement on willingness to seek psychotherapy, regardless of the combination of the four chatbot components participants were assigned (ie., component turned off or on).||||0.042
72526855|NCT04806165|144583874|SUPERIORITY|To improve the quality of the imputations, gender, age, and race were included as auxiliary variables. We generated ten imputed datasets with the predictive mean matching method and pooled coefficients, degrees of freedom, and standard errors with Rubin's (1987) rules. As a sensitivity analysis, we also ran the same models using full information maximum likelihood to handle missing data.|Regression (Beta) Coefficient|-0.08||||0.89|TWO_SIDED|||||"We interpreted absolute ß values below 0.2 as small, between 0.2 and 0.5 as medium, and greater than 0.5 as large.~We defined sufficiently large main effects as those with p values ≤ .05 or with 95% confidence intervals that do not include 0."|Linear Mixed Effects Model|The linear mixed effects models incorporated a random intercept to accommodate the correlation of repeated measures within participants.||This analysis explores the interaction effects of 2-week time since engagement with the intervention and the motivational interviewing (MI) component on participant willingness to seek psychotherapy for concerns related to their eating, weight, and/or shape concerns. since engagement with the intervention.||||0.89
72526856|NCT04806165|144583874|SUPERIORITY|To improve the quality of the imputations, gender, age, and race were included as auxiliary variables. We generated ten imputed datasets with the predictive mean matching method and pooled coefficients, degrees of freedom, and standard errors with Rubin's (1987) rules. As a sensitivity analysis, we also ran the same models using full information maximum likelihood to handle missing data.|Regression (Beta) Coefficient|0.34||||0.69|TWO_SIDED|||||"We interpreted absolute ß values below 0.2 as small, between 0.2 and 0.5 as medium, and greater than 0.5 as large.~We defined sufficiently large main effects as those with p values ≤ .05 or with 95% confidence intervals that do not include 0."|Linear Mixed Effects Model|The linear mixed effects models incorporated a random intercept to accommodate the correlation of repeated measures within participants.||This analysis explores the interaction effects of 6-week time since engagement with the intervention and the motivational interviewing (MI) component on participant willingness to seek psychotherapy for concerns related to their eating, weight, and/or shape concerns. since engagement with the intervention.||||0.69
72526857|NCT04806165|144583874|SUPERIORITY|To improve the quality of the imputations, gender, age, and race were included as auxiliary variables. We generated ten imputed datasets with the predictive mean matching method and pooled coefficients, degrees of freedom, and standard errors with Rubin's (1987) rules. As a sensitivity analysis, we also ran the same models using full information maximum likelihood to handle missing data.|Regression (Beta) Coefficient|-0.69||||0.4|TWO_SIDED|||||"We interpreted absolute ß values below 0.2 as small, between 0.2 and 0.5 as medium, and greater than 0.5 as large.~We defined sufficiently large main effects as those with p values ≤ .05 or with 95% confidence intervals that do not include 0."|Linear Mixed Effects Model|The linear mixed effects models incorporated a random intercept to accommodate the correlation of repeated measures within participants.||This analysis explores the interaction effects of 14-week time since engagement with the intervention and the motivational interviewing (MI) component on participant willingness to seek psychotherapy for concerns related to their eating, weight, and/or shape concerns. since engagement with the intervention.||||0.40
72571359|NCT04711902|144671359|OTHER|estimation and confidence interval|Mixed model repeated measures (MMRM)|-1.65|||||TWO_SIDED|95.0|-2.35|-0.94|||Mixed Models Analysis|||||-0.94|-2.35|
72571360|NCT04711902|144671360|OTHER|estimation and confidence interval|Mixed model repeated scores (MMRM)|4.2|||||TWO_SIDED|95.0|0.94|7.46|||Mixed Models Analysis|||||7.46|0.94|
72407129|NCT02477020|144322866|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.542||||0.263|TWO_SIDED|95.0|0.722|3.292|||Regression, Logistic||TAK-063 versus Placebo. The p-values were obtained using a logistic regression model adjusting for treatment and the Baseline PANSS total score.|Week 5||3.292|0.722|0.263
72407130|NCT02477020|144322866|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.567||||0.253||95.0|0.725|3.388|||Regression, Logistic||TAK-063 versus Placebo. The p-values were obtained using a logistic regression model adjusting for treatment and the Baseline PANSS total score.|Week 6||3.388|0.725|0.253
72571361|NCT04711902|144671361|OTHER|estimation and confidence interval|Mixed model repeated measures (MMRM)|-0.4|||||TWO_SIDED|95.0|-0.58|-0.21|||Mixed Models Analysis|||||-0.21|-0.58|
72526858|NCT04806165|144583874|SUPERIORITY|To improve the quality of the imputations, gender, age, and race were included as auxiliary variables. We generated ten imputed datasets with the predictive mean matching method and pooled coefficients, degrees of freedom, and standard errors with Rubin's (1987) rules. As a sensitivity analysis, we also ran the same models using full information maximum likelihood to handle missing data.|Regression (Beta) Coefficient|0.35||||0.55|TWO_SIDED|||||"We interpreted absolute ß values below 0.2 as small, between 0.2 and 0.5 as medium, and greater than 0.5 as large.~We defined sufficiently large main effects as those with p values ≤ .05 or with 95% confidence intervals that do not include 0."|Linear Mixed Effects Model|The linear mixed effects models incorporated a random intercept to accommodate the correlation of repeated measures within participants.||This analysis explores the interaction effects of 2-week time since engagement with the intervention and the psychoeducation (PE) component on participant willingness to seek psychotherapy for concerns related to their eating, weight, and/or shape concerns. since engagement with the intervention.||||0.55
72407131|NCT02477020|144322867|SUPERIORITY_OR_OTHER||Least square mean difference|-0.05|STANDARD_ERROR_OF_MEAN|0.095||0.619|TWO_SIDED|95.0|-0.23|0.14||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. Baseline CGI-S score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction and Baseline CGI-S score-by-week interaction.|Change at Week 1||0.14|-0.23|0.619
72407132|NCT02477020|144322867|SUPERIORITY_OR_OTHER||Least square mean difference|-0.21|STANDARD_ERROR_OF_MEAN|0.136||0.116|TWO_SIDED|95.0|-0.48|0.05||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. Baseline CGI-S score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction and Baseline CGI-S score-by-week interaction.|Change at Week 2||0.05|-0.48|0.116
72407133|NCT02477020|144322867|SUPERIORITY_OR_OTHER||Least square mean difference|-0.44|STANDARD_ERROR_OF_MEAN|0.166||0.009|TWO_SIDED|95.0|-0.77|-0.11||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. Baseline CGI-S score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction and Baseline CGI-S score-by-week interaction.|Change at Week 3||-0.11|-0.77|0.009
72407134|NCT02477020|144322867|SUPERIORITY_OR_OTHER||Least square mean difference|-0.36|STANDARD_ERROR_OF_MEAN|0.18||0.049|TWO_SIDED|95.0|-0.72|0.0||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. Baseline CGI-S score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction and Baseline CGI-S score-by-week interaction.|Change at Week 4||0.00|-0.72|0.049
72407135|NCT02477020|144322867|SUPERIORITY_OR_OTHER||Least square mean difference|-0.47|STANDARD_ERROR_OF_MEAN|0.191||0.016|TWO_SIDED|95.0|-0.85|-0.09||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. Baseline CGI-S score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction and Baseline CGI-S score-by-week interaction.|Change at Week 5||-0.09|-0.85|0.016
72407136|NCT02477020|144322867|SUPERIORITY_OR_OTHER||Least square mean difference|-0.43|STANDARD_ERROR_OF_MEAN|0.202||0.035||95.0|-0.83|-0.03||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. Baseline CGI-S score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction and Baseline CGI-S score-by-week interaction.|Change at Week 6||-0.03|-0.83|0.035
72526859|NCT04806165|144583874|SUPERIORITY|To improve the quality of the imputations, gender, age, and race were included as auxiliary variables. We generated ten imputed datasets with the predictive mean matching method and pooled coefficients, degrees of freedom, and standard errors with Rubin's (1987) rules. As a sensitivity analysis, we also ran the same models using full information maximum likelihood to handle missing data.|Regression (Beta) Coefficient|0.88||||0.32|TWO_SIDED|||||"We interpreted absolute ß values below 0.2 as small, between 0.2 and 0.5 as medium, and greater than 0.5 as large.~We defined sufficiently large main effects as those with p values ≤ .05 or with 95% confidence intervals that do not include 0."|Linear Mixed Effects Model|The linear mixed effects models incorporated a random intercept to accommodate the correlation of repeated measures within participants.||This analysis explores the interaction effects of 6-week time since engagement with the intervention and the psychoeducation (PE) component on participant willingness to seek psychotherapy for concerns related to their eating, weight, and/or shape concerns. since engagement with the intervention.||||0.32
72571362|NCT03347422|144671392|SUPERIORITY||Odds Ratio (OR)|15.94|||<|0.001|TWO_SIDED|95.0|2.88|88.04||Threshold for significance was 0.05.|Cochran-Mantel-Haenszel||Stratified by baseline hemoglobin (\< median versus \>=median) and geographic region (Asia/Other, North America, and Europe).|A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measures were reported and continued when primary outcome measure was statistically significant at two-sided 0.05 level.||88.04|2.88|<0.001
72571363|NCT03347422|144671394|SUPERIORITY||LS mean difference|2.56|STANDARD_ERROR_OF_MEAN|0.408|<|0.001|TWO_SIDED|95.0|1.75|3.38||Threshold of significance at 0.05 level.|Mixed model for repeated measures|||A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measures were reported and continued when previous outcome measure was statistically significant at two-sided 0.05 level.||3.38|1.75|<0.001
72407137|NCT02477020|144322868|SUPERIORITY_OR_OTHER||Least square mean difference|-0.04|STANDARD_ERROR_OF_MEAN|0.128||0.746|TWO_SIDED|95.0|-0.29|0.21||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. Baseline CGI-S score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction and Baseline CGI-S score-by-week interaction.|Week 1||0.21|-0.29|0.746
72407138|NCT02477020|144322868|SUPERIORITY_OR_OTHER||Least mean square difference|-0.37|STANDARD_ERROR_OF_MEAN|0.173||0.034|TWO_SIDED|95.0|-0.72|-0.03||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. Baseline CGI-S score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction and Baseline CGI-S score-by-week interaction.|Week 2||-0.03|-0.72|0.034
72407139|NCT02477020|144322868|SUPERIORITY_OR_OTHER||Least square mean difference|-0.57|STANDARD_ERROR_OF_MEAN|0.203||0.006|TWO_SIDED|95.0|-0.97|-0.17||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. Baseline CGI-S score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction and Baseline CGI-S score-by-week interaction.|Week 3||-0.17|-0.97|0.006
72407140|NCT02477020|144322868|SUPERIORITY_OR_OTHER||Least square mean difference|-0.55|STANDARD_ERROR_OF_MEAN|0.22||0.013|TWO_SIDED|95.0|-0.99|-0.12||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. Baseline CGI-S score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction and Baseline CGI-S score-by-week interaction.|Week 4||-0.12|-0.99|0.013
72407141|NCT02477020|144322868|SUPERIORITY_OR_OTHER||Least mean square difference|-0.56|STANDARD_ERROR_OF_MEAN|0.238||0.02|TWO_SIDED|95.0|-1.03|-0.09||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. Baseline CGI-S score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction and Baseline CGI-S score-by-week interaction.|Week 5||-0.09|-1.03|0.020
72407142|NCT02477020|144322868|SUPERIORITY_OR_OTHER||Least square mean difference|-0.66|STANDARD_ERROR_OF_MEAN|0.244||0.007|TWO_SIDED|95.0|-1.15|-0.18||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. Baseline CGI-S score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction and Baseline CGI-S score-by-week interaction.|Week 6||-0.18|-1.15|0.007
72407143|NCT02477020|144322869|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.726||||0.077|TWO_SIDED|95.0|0.899|8.267||No multiplicity adjustment.|Regression, Logistic||TAK-063 versus Placebo. The p-values were obtained using a logistic regression model adjusting for treatment and the Baseline CGI-S score.|Week 1||8.267|0.899|0.077
72407144|NCT02477020|144322869|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.331||||0.036|TWO_SIDED|95.0|1.055|5.153||No multiplicity adjustment.|Regression, Logistic||TAK-063 versus Placebo. The p-values were obtained using a logistic regression model adjusting for treatment and the Baseline CGI-S score.|Week 2||5.153|1.055|0.036
72526860|NCT04806165|144583874|SUPERIORITY|To improve the quality of the imputations, gender, age, and race were included as auxiliary variables. We generated ten imputed datasets with the predictive mean matching method and pooled coefficients, degrees of freedom, and standard errors with Rubin's (1987) rules. As a sensitivity analysis, we also ran the same models using full information maximum likelihood to handle missing data.|Regression (Beta) Coefficient|-0.37||||0.63|TWO_SIDED|||||"We interpreted absolute ß values below 0.2 as small, between 0.2 and 0.5 as medium, and greater than 0.5 as large.~We defined sufficiently large main effects as those with p values ≤ .05 or with 95% confidence intervals that do not include 0."|Linear Mixed Effects Model|The linear mixed effects models incorporated a random intercept to accommodate the correlation of repeated measures within participants.||This analysis explores the interaction effects of 14-week time since engagement with the intervention and the psychoeducation (PE) component on participant willingness to seek psychotherapy for concerns related to their eating, weight, and/or shape concerns. since engagement with the intervention.||||0.63
72526861|NCT04806165|144583874|SUPERIORITY|To improve the quality of the imputations, gender, age, and race were included as auxiliary variables. We generated ten imputed datasets with the predictive mean matching method and pooled coefficients, degrees of freedom, and standard errors with Rubin's (1987) rules. As a sensitivity analysis, we also ran the same models using full information maximum likelihood to handle missing data.|Regression (Beta) Coefficient|0.08||||0.9|TWO_SIDED|||||"We interpreted absolute ß values below 0.2 as small, between 0.2 and 0.5 as medium, and greater than 0.5 as large.~We defined sufficiently large main effects as those with p values ≤ .05 or with 95% confidence intervals that do not include 0."|Linear Mixed Effects Model|The linear mixed effects models incorporated a random intercept to accommodate the correlation of repeated measures within participants.||This analysis explores the interaction effects of 2-week time since engagement with the intervention and the personalized recommendation (PR) component on participant willingness to seek psychotherapy for concerns related to their eating, weight, and/or shape concerns. since engagement with the intervention.||||0.90
72407145|NCT02477020|144322869|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.69||||0.015|TWO_SIDED|95.0|1.208|5.99||No multiplicity adjustment.|Regression, Logistic||TAK-063 versus Placebo. The p-values were obtained using a logistic regression model adjusting for treatment and the Baseline CGI-S score.|Week 3||5.990|1.208|0.015
72407146|NCT02477020|144322869|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.737||||0.158|TWO_SIDED|95.0|0.807|3.735||No multiplicity adjustment.|Regression, Logistic||TAK-063 versus Placebo. The p-values were obtained using a logistic regression model adjusting for treatment and the Baseline CGI-S score.|Week 4||3.735|0.807|0.158
72407147|NCT02477020|144322869|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.739||||0.164|TWO_SIDED|95.0|0.798|3.789||No multiplicity adjustment.|Regression, Logistic||TAK-063 versus Placebo. The p-values were obtained using a logistic regression model adjusting for treatment and the Baseline CGI-S score.|Week 5||3.789|0.798|0.164
72407148|NCT02477020|144322869|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.44||||0.003|TWO_SIDED|95.0|1.523|7.77||No multiplicity adjustment.|Regression, Logistic||TAK-063 versus Placebo. The p-values were obtained using a logistic regression model adjusting for treatment and the Baseline CGI-S score.|Week 6||7.770|1.523|0.003
72407149|NCT02477020|144322870|SUPERIORITY_OR_OTHER||Least square mean difference|1.8|STANDARD_ERROR_OF_MEAN|1.547||0.246|TWO_SIDED|95.0|-1.26|4.86||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. Baseline BACS total score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction and Baseline BACS total score-by-week interaction.|Change at Week 3||4.86|-1.26|0.246
72571364|NCT03347422|144671395|SUPERIORITY||LS mean difference|8.93|STANDARD_ERROR_OF_MEAN|2.45|<|0.001|TWO_SIDED|95.0|4.0|13.85||Threshold of significance at 0.05 level.|Mixed model for repeated measures|||A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measures were reported and continued when previous outcome measure was statistically significant at two-sided 0.05 level.||13.85|4.00|<0.001
72407150|NCT02477020|144322870|SUPERIORITY_OR_OTHER||Least square mean difference|2.2|STANDARD_ERROR_OF_MEAN|1.767||0.216|TWO_SIDED|95.0|-1.3|5.69||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|Least square mean difference||TAK-063 - Placebo. Baseline BACS total score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction and Baseline BACS total score-by-week interaction|Change at Week 6||5.69|-1.30|0.216
72407151|NCT02477020|144322871|SUPERIORITY_OR_OTHER||Least mean square difference|-0.38|STANDARD_ERROR_OF_MEAN|1.664||0.82|TWO_SIDED|95.0|-3.67|2.91||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. Baseline BNSS total score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction and Baseline BNSS total score-by-week interaction.|Change at Week 3||2.91|-3.67|0.820
72407152|NCT02477020|144322871|SUPERIORITY_OR_OTHER||Least square mean difference|-2.87|STANDARD_ERROR_OF_MEAN|2.05||0.163|TWO_SIDED|95.0|-6.93|1.18||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. Baseline BNSS total score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction and Baseline BACS total score-by-week interaction.|Change at Week 6||1.18|-6.93|0.163
72407153|NCT02477020|144322872|SUPERIORITY_OR_OTHER||Least square mean difference|2.69|STANDARD_ERROR_OF_MEAN|1.769||0.131|TWO_SIDED|95.0|-0.81|6.19||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. Baseline PSP score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction and Baseline PSP score-by-week interaction.|Change at Week 3||6.19|-0.81|0.131
72407154|NCT02477020|144322872|SUPERIORITY_OR_OTHER||Least square mean difference|2.62|STANDARD_ERROR_OF_MEAN|2.313||0.26|TWO_SIDED|95.0|-1.96|7.19||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. Baseline PSP score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction and Baseline PSP score-by-week interaction.|Change at Week 6||7.19|-1.96|0.260
72407155|NCT02477020|144322873|SUPERIORITY_OR_OTHER||Least square mean difference|0.06|STANDARD_ERROR_OF_MEAN|1.855||0.973|TWO_SIDED|95.0|-3.61|3.73||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. Baseline UPSA-B composite score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction and Baseline UPSA-B composite score-by-week interaction.|Change at Week 3||3.73|-3.61|0.973
72571365|NCT02633488|144671410|EQUIVALENCE|equivalence defined as less that 2 SD in FMD between 2 treatments|||||>|0.05||||||FMD % change exceeded the threshold of our statistical significance test, i.e. the null hypothesis that there was no effect of metformin remained tenable.|t-test, 2 sided|||||||>0.05
72407156|NCT02477020|144322873|SUPERIORITY_OR_OTHER||Least mean square difference|-0.54|STANDARD_ERROR_OF_MEAN|2.255||0.812|TWO_SIDED|95.0|-5.0|3.92||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. Baseline UPSA-B composite score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction and Baseline UPSA-B composite score-by-week interaction.|Change at Week 6||3.92|-5.00|0.812
72407157|NCT02099721|144322886|EQUIVALENCE|The equivalence margin is a hazard ratio significantly above 0.70.|Hazard Ratio (HR)|0.47|||||TWO_SIDED|95.0|0.38|0.57|||||The hazard ratio, estimated by a Cox proportional hazard model, has time to first treated VT/VF for 1.5 Prevention in the numerator, with Secondary Prevention in the denominator.|"H0: Hazard ratio of Implanted 1.5 patients (Group C) to implanted secondary patients (Group A) ≤ 0.70~HA: Hazard ratio of Implanted 1.5 patients (Group C) to implanted secondary patients (Group A) \> 0.70"||0.57|0.38|
72407158|NCT02099721|144322887|SUPERIORITY|A hazard ratio significantly below 1 indicates reduced mortality in the 1.5 implanted group.|Hazard Ratio (HR)|0.51|||<|0.0001|TWO_SIDED|95.0|0.4|0.66||The p-value is for the effect of treatment group on time to death, adjusting for the baseline covariates of age, gender, QRS duration, ischemic cardiomyopathy, LBBB, NYHA classification, diabetes, LVEF, syncope, NSVT and PVCs.|Wald chi-square||Multiple imputations were employed to account for missing baseline covariates.|The null hypothesis is that the hazard ratio of implanted to non-implanted 1.5 patients = 1. The alternative is that the ratio is not equal to 1.||0.66|0.40|< 0.0001
72407159|NCT03670810|144322892|SUPERIORITY||Odds Ratio (OR)|3.83|||<|0.001|TWO_SIDED|95.0|2.56|5.73|||Regression, Logistic|||||5.73|2.56|<0.001
72407160|NCT03670810|144322892|SUPERIORITY||Odds Ratio (OR)|4.56|||<|0.001|TWO_SIDED|95.0|3.07|6.77|||Regression, Logistic|||||6.77|3.07|<0.001
72407161|NCT03670810|144322893|SUPERIORITY||Odds Ratio (OR)|3.77|||<|0.001|TWO_SIDED|95.0|2.1|6.76|||Regression, Logistic|||||6.76|2.10|<.001
72571366|NCT00415194|144671412|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.87||||0.082|TWO_SIDED|95.0|0.75|1.02|||Stratified Log Rank|||||1.02|0.75|0.082
72407162|NCT03670810|144322893|SUPERIORITY||Odds Ratio (OR)|7.24|||<|0.001|TWO_SIDED|95.0|4.13|12.67|||Regression, Logistic|||||12.67|4.13|<.001
72407163|NCT03670810|144322894|SUPERIORITY||Odds Ratio (OR)|2.71|||<|0.001|TWO_SIDED|95.0|2.05|3.57|||Regression, Logistic|||||3.57|2.05|<0.001
72571367|NCT00415194|144671413|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.88||||0.166|TWO_SIDED|95.0|0.76|1.03|||Stratified Log Rank|||||1.03|0.76|0.166
72407164|NCT03670810|144322894|SUPERIORITY||Odds Ratio (OR)|2.68|||<|0.001|TWO_SIDED|95.0|2.04|3.53|||Regression, Logistic|||||3.53|2.04|<0.001
72407165|NCT03670810|144322895|SUPERIORITY||Odds Ratio (OR)|2.91|||<|0.001|TWO_SIDED|95.0|2.11|4.01|||Regression, Logistic|||||4.01|2.11|<0.001
72407166|NCT03670810|144322895|SUPERIORITY||Odds Ratio (OR)|3.5|||<|0.001|TWO_SIDED|95.0|2.53|4.85|||Regression, Logistic|||||4.85|2.53|<0.001
72407167|NCT03670810|144322896|SUPERIORITY||Odds Ratio (OR)|3.52|||<|0.001|TWO_SIDED|95.0|2.05|6.02|||Regression, Logistic|||||6.02|2.05|<0.001
72571368|NCT00415194|144671414|SUPERIORITY_OR_OTHER|||||||0.061||95.0|||||Unadjusted normal distribution|p-value is based on an unadjusted, normal distribution approximation for differences in rates.||||||0.061
72571369|NCT00415194|144671415|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.92||||0.811|TWO_SIDED|95.0|0.56|1.53|||Stratified Log Rank|||||1.53|0.56|0.811
72571370|NCT00415194|144671416|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.86||||0.2|TWO_SIDED|95.0|0.69|1.07|||Stratified Log Rank|||||1.07|0.69|0.20
72407168|NCT03670810|144322896|SUPERIORITY||Odds Ratio (OR)|4.67|||<|0.001|TWO_SIDED|95.0|2.77|7.88|||Regression, Logistic|||||7.88|2.77|<0.001
72407169|NCT03670810|144322897|SUPERIORITY||Odds Ratio (OR)|2.3||||0.004|TWO_SIDED|95.0|1.3|4.04|||Regression, Logistic|||||4.04|1.30|0.004
72407170|NCT03670810|144322897|SUPERIORITY||Odds Ratio (OR)|4.09|||<|0.001|TWO_SIDED|95.0|2.41|6.94|||Regression, Logistic|||||6.94|2.41|<0.001
72407171|NCT03670810|144322898|SUPERIORITY||Odds Ratio (OR)|3.29|||<|0.001|TWO_SIDED|95.0|1.8|6.02|||Regression, Logistic|||||6.02|1.80|<0.001
72407172|NCT03670810|144322898|SUPERIORITY||Odds Ratio (OR)|3.56|||<|0.001|TWO_SIDED|95.0|1.97|6.42|||Regression, Logistic|||||6.42|1.97|<0.001
72407173|NCT03670810|144322899|SUPERIORITY||Odds Ratio (OR)|2.22|||<|0.001|TWO_SIDED|95.0|1.48|3.33|||Regression, Logistic|||||3.33|1.48|<0.001
72407174|NCT03670810|144322899|SUPERIORITY||Odds Ratio (OR)|2.46|||<|0.001|TWO_SIDED|95.0|1.65|3.67|||Regression, Logistic|||||3.67|1.65|<0.001
72407175|NCT03670810|144322900|SUPERIORITY||Odds Ratio (OR)|2.73||||0.031|TWO_SIDED|95.0|1.1|6.78|||Regression, Logistic|||||6.78|1.10|0.031
72407176|NCT03670810|144322900|SUPERIORITY||Odds Ratio (OR)|5.64|||<|0.001|TWO_SIDED|95.0|2.4|13.25|||Regression, Logistic|||||13.25|2.40|<0.001
72407177|NCT03670810|144322901|SUPERIORITY||Odds Ratio (OR)|1.74|||<|0.001|TWO_SIDED|95.0|1.29|2.35|||Regression, Logistic|||||2.35|1.29|<0.001
72407178|NCT03670810|144322901|SUPERIORITY||Odds Ratio (OR)|1.63||||0.001|TWO_SIDED|95.0|1.21|2.2|||Regression, Logistic|||||2.20|1.21|0.001
72407179|NCT03670810|144322902|SUPERIORITY||Odds Ratio (OR)|0.46|||<|0.001|TWO_SIDED|95.0|0.33|0.65|||Regression, Logistic|||||0.65|0.33|<0.001
72407180|NCT03670810|144322902|SUPERIORITY||Odds Ratio (OR)|0.43|||<|0.001|TWO_SIDED|95.0|0.3|0.6|||Regression, Logistic|||||0.60|0.30|<0.001
72407181|NCT03670810|144322903|SUPERIORITY||Odds Ratio (OR)|2.77|||<|0.001|TWO_SIDED|95.0|1.79|4.28|||Regression, Logistic|||||4.28|1.79|<0.001
72526862|NCT04806165|144583874|SUPERIORITY|To improve the quality of the imputations, gender, age, and race were included as auxiliary variables. We generated ten imputed datasets with the predictive mean matching method and pooled coefficients, degrees of freedom, and standard errors with Rubin's (1987) rules. As a sensitivity analysis, we also ran the same models using full information maximum likelihood to handle missing data.|Regression (Beta) Coefficient|-0.95||||0.27|TWO_SIDED|||||"We interpreted absolute ß values below 0.2 as small, between 0.2 and 0.5 as medium, and greater than 0.5 as large.~We defined sufficiently large main effects as those with p values ≤ .05 or with 95% confidence intervals that do not include 0."|Linear Mixed Effects Model|The linear mixed effects models incorporated a random intercept to accommodate the correlation of repeated measures within participants.||This analysis explores the interaction effects of 6-week time since engagement with the intervention and the personalized recommendation (PR) component on participant willingness to seek psychotherapy for concerns related to their eating, weight, and/or shape concerns. since engagement with the intervention.||||0.27
72576763|NCT00261443|144680647|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.05||||0.522|TWO_SIDED|95.0|-0.22|0.11||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 12 Comparison||0.11|-0.22|0.522
72407182|NCT03670810|144322903|SUPERIORITY||Odds Ratio (OR)|3.37|||<|0.001|TWO_SIDED|95.0|2.2|5.15|||Regression, Logistic|||||5.15|2.20|<0.001
72407183|NCT03670810|144322905|SUPERIORITY||Odds Ratio (OR)|6.4||||0.086|TWO_SIDED|95.0|0.77|53.37|||Regression, Logistic|||Pain Freedom 30 Min. Postdose||53.37|0.77|0.086
72407184|NCT03670810|144322905|SUPERIORITY||Odds Ratio (OR)|7.24||||0.065|TWO_SIDED|95.0|0.89|59.08|||Regression, Logistic|||Pain Freedom 30 Min. Postdose||59.08|0.89|0.065
72407185|NCT03670810|144322905|SUPERIORITY||Odds Ratio (OR)|3.08||||0.004|TWO_SIDED|95.0|1.42|6.68|||Regression, Logistic|||Pain Free 1 Hour Postdose||6.68|1.42|0.004
72407186|NCT03670810|144322905|SUPERIORITY||Odds Ratio (OR)|7.04|||<|0.001|TWO_SIDED|95.0|3.43|14.44|||Regression, Logistic|||Pain Free 1 Hour Postdose||14.44|3.43|<0.001
72407187|NCT03670810|144322905|SUPERIORITY||Odds Ratio (OR)|1.41||||0.065|TWO_SIDED|95.0|0.98|2.03|||Regression, Logistic|||Pain Relief 30 Min Postdose 100 mg||2.03|0.98|0.065
72407188|NCT03670810|144322905|SUPERIORITY||Odds Ratio (OR)|1.77||||0.001|TWO_SIDED|95.0|1.25|2.52|||Regression, Logistic|||Pain Relief 30 Min. Postdose 200 mg||2.52|1.25|0.001
72407189|NCT03670810|144322905|SUPERIORITY||Odds Ratio (OR)|2.31|||<|0.001|TWO_SIDED|95.0|1.74|3.06|||Regression, Logistic|||Pain Relief 1 Hour Postdose 100 mg||3.06|1.74|<0.001
72407190|NCT03670810|144322905|SUPERIORITY||Odds Ratio (OR)|2.18|||<|0.001|TWO_SIDED|95.0|1.64|2.88|||Regression, Logistic|||Pain Relief 1 Hour Postdose 200 mg||2.88|1.64|<0.001
72407191|NCT03670810|144322905|SUPERIORITY||Odds Ratio (OR)|1.11||||0.651|TWO_SIDED|95.0|0.71|1.71|||Regression, Logistic|||Freedom from MBS 30 Min 100 mg||1.71|0.71|0.651
72407192|NCT03670810|144322905|SUPERIORITY||Odds Ratio (OR)|1.3||||0.22|TWO_SIDED|95.0|0.85|1.98|||Regression, Logistic|||Freedom from MBS 30 Min. 200 mg||1.98|0.85|0.220
72407193|NCT03670810|144322905|SUPERIORITY||Odds Ratio (OR)|1.1||||0.593|TWO_SIDED|95.0|0.78|1.54|||Regression, Logistic|||Freedom from MBS 1 Hour 100 mg||1.54|0.78|0.593
72407194|NCT03670810|144322905|SUPERIORITY||Odds Ratio (OR)|1.43||||0.03|TWO_SIDED|95.0|1.04|1.98|||Regression, Logistic|||Freedom from MBS 1 Hour 200 mg||1.98|1.04|0.030
72407195|NCT03670810|144322906|SUPERIORITY|||||||0.092|||||||ANCOVA|||||||0.092
72407196|NCT03670810|144322906|SUPERIORITY|||||||0.211|||||||ANCOVA|||||||0.211
72407197|NCT03670810|144322907|SUPERIORITY||Odds Ratio (OR)|2.85|||<|0.001|TWO_SIDED|95.0|2.01|4.05|||Regression, Logistic|||||4.05|2.01|<0.001
72407198|NCT03670810|144322907|SUPERIORITY||Odds Ratio (OR)|3.0|||<|0.001|TWO_SIDED|95.0|2.12|4.26|||Regression, Logistic|||||4.26|2.12|<0.001
72407199|NCT03670810|144322908|SUPERIORITY|||||||0.056|||||||ANOVA|||Social Functioning||||0.056
72407200|NCT03670810|144322908|SUPERIORITY|||||||0.267|||||||ANOVA|||Social Functioning||||0.267
72407201|NCT03670810|144322908|SUPERIORITY|||||||0.003|||||||ANOVA|||Migraine Symptoms 100 mg||||0.003
72407202|NCT03670810|144322908|SUPERIORITY|||||||0.002|||||||ANOVA|||Migraine Symptoms 200 mg||||0.002
72407203|NCT03670810|144322908|SUPERIORITY|||||||0.014|||||||ANOVA|||Feeling/Concerns 100 mg||||0.014
72407204|NCT03670810|144322908|SUPERIORITY|||||||0.018|||||||ANOVA|||Feelings/Concerns 200 mg||||0.018
72407205|NCT03670810|144322909|SUPERIORITY||Odds Ratio (OR)|1.25||||0.101|TWO_SIDED|95.0|0.96|1.62|||Regression, Logistic|||Recommend Treatment - Agree Strongly Agree||1.62|0.96|0.101
72407206|NCT03670810|144322909|SUPERIORITY||Odds Ratio (OR)|1.28||||0.063|TWO_SIDED|95.0|0.99|1.67|||Regression, Logistic|||Recommend Treatment Agree/Strongly Agree||1.67|0.99|0.063
72407207|NCT03670810|144322909|SUPERIORITY||Odds Ratio (OR)|0.89||||0.376|TWO_SIDED|95.0|0.68|1.16|||Regression, Logistic|||Willing to Take This Treatment Again - Agree/Strongly Agree||1.16|0.68|0.376
72407208|NCT03670810|144322909|SUPERIORITY||Odds Ratio (OR)|0.79||||0.082|TWO_SIDED|95.0|0.6|1.03|||Regression, Logistic|||Willing to Take This Treatment Again - Agree/Strongly Agree||1.03|0.60|0.082
72407209|NCT03670810|144322909|SUPERIORITY||Odds Ratio (OR)|1.25||||0.096|TWO_SIDED|95.0|0.96|1.62|||Regression, Logistic|||Extremely/Very Satisfied||1.62|0.96|0.096
72571371|NCT01297465|144671418|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.28|STANDARD_ERROR_OF_MEAN|0.947|||TWO_SIDED|95.0|-3.15|0.59|||ANOVA|ANOVA model adjusted for treatment and country|The primary efficacy variable was to be analyzed using an analysis of variance (ANOVA) model, adjusted for treatment and country.|The null hypothesis was that the difference between the mean number of oocytes is less than (-3) or greater than (+3) between the two treatment arm. The alternate hypothesis was that the difference is between (-3) and (+3). The study had 80% power to show that the group randomized to Pergoveris® has an absolute difference of no more than 3 oocytes retrieved in comparison to the group randomized to GONAL-f®/Pergoveris®||0.59|-3.15|
72571372|NCT02397408|144671452|OTHER||||||<|0.008|||||||Wilcoxon (Mann-Whitney)|||||||<.008
72625321|NCT01098747|144780087|SUPERIORITY_OR_OTHER||Difference in proportion|-52.79|||<|0.001|TWO_SIDED|95.0|-66.77|-38.81||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||8 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-38.81|-66.77|<0.001
72625322|NCT01098747|144780087|SUPERIORITY_OR_OTHER||Difference in proportion|6.05||||0.256|TWO_SIDED|95.0|-4.75|16.84||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||8 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||16.84|-4.75|0.256
72407210|NCT03670810|144322909|SUPERIORITY||Odds Ratio (OR)|1.38||||0.016|TWO_SIDED|95.0|1.06|1.8|||Regression, Logistic|||Extremely/Very Satisfied||1.80|1.06|0.016
72407211|NCT03670810|144322909|SUPERIORITY||Odds Ratio (OR)|1.12||||0.445|TWO_SIDED|95.0|0.84|1.49|||Regression, Logistic|||Prefer This Treatment||1.49|0.84|0.445
72407212|NCT03670810|144322909|SUPERIORITY||Odds Ratio (OR)|1.19||||0.243|TWO_SIDED|95.0|0.89|1.58|||Regression, Logistic|||||1.58|0.89|0.243
72407213|NCT03670810|144322910|SUPERIORITY|||||||0.142|||||||ANCOVA|||||||0.142
72625323|NCT01098747|144780088|SUPERIORITY_OR_OTHER||Difference in proportion|6.34||||0.078|TWO_SIDED|95.0|1.34|11.34||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||0.5 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||11.34|1.34|0.078
72407214|NCT03670810|144322911|SUPERIORITY||Odds Ratio (OR)|3.01||||0.004|TWO_SIDED|95.0|1.42|6.4|||Regression, Logistic|||||6.40|1.42|0.004
72407215|NCT03670810|144322911|SUPERIORITY||Odds Ratio (OR)|4.58|||<|0.001|TWO_SIDED|95.0|2.22|9.47|||Regression, Logistic|||||9.47|2.22|<0.001
72407216|NCT03670810|144322912|SUPERIORITY||Odds Ratio (OR)|2.51|||<|0.001|TWO_SIDED|95.0|1.74|3.62|||Regression, Logistic|||||3.62|1.74|<0.001
72407217|NCT03670810|144322912|SUPERIORITY||Odds Ratio (OR)|3.61|||<|0.001|TWO_SIDED|95.0|2.5|5.2|||Regression, Logistic|||||5.20|2.50|<0.001
72407218|NCT03670810|144322913|SUPERIORITY||Odds Ratio (OR)|1.01||||0.953|TWO_SIDED|95.0|0.75|1.36|||Regression, Logistic|||Nausea||1.36|0.75|0.953
72407219|NCT03670810|144322913|SUPERIORITY||Odds Ratio (OR)|1.05||||0.768|TWO_SIDED|95.0|0.78|1.41|||Regression, Logistic|||Nausea||1.41|0.78|0.768
72407220|NCT03670810|144322913|SUPERIORITY||Odds Ratio (OR)|0.53|||<|0.001|TWO_SIDED|95.0|0.39|0.71|||Regression, Logistic|||Phonophobia||0.71|0.39|<0.001
72407221|NCT03670810|144322913|SUPERIORITY||Odds Ratio (OR)|0.46|||<|0.001|TWO_SIDED|95.0|0.34|0.62|||Regression, Linear|||Phonophobia||0.62|0.34|<0.001
72407222|NCT03670810|144322913|SUPERIORITY||Odds Ratio (OR)|0.48|||<|0.001|TWO_SIDED|95.0|0.36|0.63|||Regression, Logistic|||Photophobia||0.63|0.36|<0.001
72407223|NCT03670810|144322913|SUPERIORITY||Median Difference (Net)|0.53|||<|0.001|TWO_SIDED|95.0|0.4|0.71|||Regression, Logistic|||Photophobia||0.71|0.40|<0.001
72407224|NCT03670810|144322913|SUPERIORITY||Odds Ratio (OR)|0.46||||0.129|TWO_SIDED|95.0|0.17|1.25|||Regression, Logistic|||Vomiting||1.25|0.17|0.129
72407225|NCT03670810|144322913|SUPERIORITY||Odds Ratio (OR)|1.12||||0.769|TWO_SIDED|95.0|0.52|2.43|||Regression, Logistic|||Vomiting||2.43|0.52|0.769
72407226|NCT03523117|144322915|SUPERIORITY||Mean Difference (Final Values)|0.3||||0.3108|TWO_SIDED||||||ANCOVA|||||||0.3108
72407227|NCT03523117|144322916|SUPERIORITY||Mean Difference (Final Values)|0.3||||0.0001|TWO_SIDED||||||ANCOVA|||||||0.0001
72407228|NCT03523117|144322917|SUPERIORITY||Mean Difference (Final Values)|15.64||||0.0001|TWO_SIDED||||||ANCOVA|||||||0.0001
72407229|NCT03523117|144322918|SUPERIORITY||Mean Difference (Final Values)|2.06||||0.0002|TWO_SIDED||||||Mixed Models Analysis|||||||0.0002
72407230|NCT02644967|144322919|OTHER|Estimation||||||0.0158||||||P-value of the overall response tested against the null rate of 11% based on 1-sided exact (Clopper-Pearson) test.|One-sided Clopper-Pearson test|||Testing the best overall confirmed response rate against the historical control rate of 0.11 (extracted from the literature review).||||0.0158
72407231|NCT02644967|144322920|OTHER|Estimation|Kaplan-Meier|5.06|||||TWO_SIDED|95.0|3.65|7.0|||||Kaplan-Meier estimate of median PFS in months.|||7.00|3.65|
72407232|NCT02644967|144322921|OTHER|Landmark analysis of overall survival at six (6) months.|Kaplan-Meier|87.5|||||TWO_SIDED|95.0|74.3|94.2|||||Kaplan-Meier estimate of percentage of participants surviving at six (6) months.|||94.2|74.3|
72407233|NCT02644967|144322922|OTHER|Landmark analysis of overall survival at twelve (12) months.|Kaplan-Meier|60.0|||||TWO_SIDED|95.0|44.7|72.4|||||Kaplan-Meier estimate of percentage of participants surviving at twelve (12) months.|||72.4|44.7|
72526863|NCT04806165|144583874|SUPERIORITY|To improve the quality of the imputations, gender, age, and race were included as auxiliary variables. We generated ten imputed datasets with the predictive mean matching method and pooled coefficients, degrees of freedom, and standard errors with Rubin's (1987) rules. As a sensitivity analysis, we also ran the same models using full information maximum likelihood to handle missing data.|Regression (Beta) Coefficient|-0.67||||0.42|TWO_SIDED|||||"We interpreted absolute ß values below 0.2 as small, between 0.2 and 0.5 as medium, and greater than 0.5 as large.~We defined sufficiently large main effects as those with p values ≤ .05 or with 95% confidence intervals that do not include 0."|Linear Mixed Effects Model|The linear mixed effects models incorporated a random intercept to accommodate the correlation of repeated measures within participants.||This analysis explores the interaction effects of 14-week time since engagement with the intervention and the personalized recommendation (PR) component on participant willingness to seek psychotherapy for concerns related to their eating, weight, and/or shape concerns. since engagement with the intervention.||||0.42
72526864|NCT04806165|144583874|SUPERIORITY|To improve the quality of the imputations, gender, age, and race were included as auxiliary variables. We generated ten imputed datasets with the predictive mean matching method and pooled coefficients, degrees of freedom, and standard errors with Rubin's (1987) rules. As a sensitivity analysis, we also ran the same models using full information maximum likelihood to handle missing data.|Regression (Beta) Coefficient|1.23||||0.04|TWO_SIDED|||||"We interpreted absolute ß values below 0.2 as small, between 0.2 and 0.5 as medium, and greater than 0.5 as large.~We defined sufficiently large main effects as those with p values ≤ .05 or with 95% confidence intervals that do not include 0."|Linear Mixed Effects Model|The linear mixed effects models incorporated a random intercept to accommodate the correlation of repeated measures within participants.||This analysis explores the interaction effects of 2-week time since engagement with the intervention and the repeated administration (RA) component on participant willingness to seek psychotherapy for concerns related to their eating, weight, and/or shape concerns. since engagement with the intervention.||||0.04
72526865|NCT04806165|144583874|SUPERIORITY|To improve the quality of the imputations, gender, age, and race were included as auxiliary variables. We generated ten imputed datasets with the predictive mean matching method and pooled coefficients, degrees of freedom, and standard errors with Rubin's (1987) rules. As a sensitivity analysis, we also ran the same models using full information maximum likelihood to handle missing data.|Regression (Beta) Coefficient|1.22||||0.16|TWO_SIDED|||||"We interpreted absolute ß values below 0.2 as small, between 0.2 and 0.5 as medium, and greater than 0.5 as large.~We defined sufficiently large main effects as those with p values ≤ .05 or with 95% confidence intervals that do not include 0."|Multilevel Models|The linear mixed effects models incorporated a random intercept to accommodate the correlation of repeated measures within participants.||This analysis explores the interaction effects of 6-week time since engagement with the intervention and the repeated administration (RA) component on participant willingness to seek psychotherapy for concerns related to their eating, weight, and/or shape concerns. since engagement with the intervention.||||0.16
72526866|NCT04806165|144583874|SUPERIORITY|To improve the quality of the imputations, gender, age, and race were included as auxiliary variables. We generated ten imputed datasets with the predictive mean matching method and pooled coefficients, degrees of freedom, and standard errors with Rubin's (1987) rules. As a sensitivity analysis, we also ran the same models using full information maximum likelihood to handle missing data.|Regression (Beta) Coefficient|0.01||||0.99|TWO_SIDED|||||"We interpreted absolute ß values below 0.2 as small, between 0.2 and 0.5 as medium, and greater than 0.5 as large.~We defined sufficiently large main effects as those with p values ≤ .05 or with 95% confidence intervals that do not include 0."|Linear Mixed Effects Model|The linear mixed effects models incorporated a random intercept to accommodate the correlation of repeated measures within participants.||This analysis explores the interaction effects of 14-week time since engagement with the intervention and the repeated administration (RA) component on participant willingness to seek psychotherapy for concerns related to their eating, weight, and/or shape concerns. since engagement with the intervention.||||0.99
72526867|NCT04806165|144583875|SUPERIORITY|To improve the quality of the imputations, gender, age, and race were included as auxiliary variables. We generated ten imputed datasets with the predictive mean matching method and pooled coefficients, degrees of freedom, and standard errors with Rubin's (1987) rules. As a sensitivity analysis, we also ran the same models using full information maximum likelihood to handle missing data.|Regression (Beta) Coefficient|-0.07|STANDARD_ERROR_OF_MEAN|0.02|<|0.001|TWO_SIDED|||||We computed both unstandardized (B) and standardized (ß) coefficients to indicate effect sizes. As suggested by Fey et al. (2023), we interpreted absolute ß values below 0.2 as small, between 0.2 and 0.5 as medium, and greater than 0.5 as large.|Linear Mixed Effects Model|The linear mixed effects models incorporated a random intercept to accommodate the correlation of repeated measures within participants.||This analysis explores the time effect of attitudinal changes over the 14 week course of the study, regardless of the combination of components participants were assigned (ie., component turned off or on). Results will help determine whether mean participant attitudes toward change for concerns related to their eating, weight, and/or shape concerns varied based on the time elapsed since engagement with the intervention (ie., do attitudinal changes post-inntervention endure over time?).||||<.001
72542572|NCT03877237|144614992|SUPERIORITY||Hodges-Lehmann median diff. vs placebo|4.23||||0.02164|TWO_SIDED|95.0|0.96|8.22||To account for multiplicity, a pre-specified testing strategy was followed to control the overall type I error rate.|Rank ANCOVA|Model includes baseline rank of outcome variable as a covariate, treatment group as a factor, and is stratified by T2DM status at randomization.||"For the primary efficacy endpoint KCCQ-TSS, the following hypothesis was tested using the significance level 0.04990~* H0: m(r(A)) = m(r(C)) versus~* H1: m(r(A)) ≠ m(r(C)) Where H0 and H1 are the null and alternative hypotheses, respectively, and m(r(A)) and m(r(C)) represent the median of the ranked changes in the primary efficacy endpoint, KCCQ-TSS, from baseline to week 16, among patients receiving dapagliflozin (Active) and placebo (Control) treatment, respectively."||8.22|0.96|0.02164
72571373|NCT01524679|144671488|SUPERIORITY|The Fisher Test with asymptotic test statistic provided by the analysis software was used.|||||<|0.0001||||||This was the only a priori defined primary endpoint. There was no adjustment for multiple comparisons.|Fisher Exact|There was no adjustment for other variables intended for the primary analysis. Confounding variables were analysed in subsequent analyses.||Nullhypothesis was the equality of response rates of the treatment group and the control group. Treatments were compared by a two-sided Fisher test on a level of significance of 0.05. The study was appropriately powered (80%) for this analysis.||||<0.0001
72571374|NCT01524679|144671489|SUPERIORITY||Mean Difference (Final Values)|0.7525||||0.0957|TWO_SIDED|95.0|0.5382|1.0521|||ANCOVA|||||1.0521|0.5382|0.0957
72571375|NCT01524679|144671490|SUPERIORITY||Mean Difference (Final Values)|0.4621||||0.0005|TWO_SIDED|95.0|0.4621|0.7106|||ANCOVA|||||0.7106|0.4621|0.0005
72571376|NCT00886288|144671546|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Chi-squared|||||||<0.0001
72571377|NCT01675661|144671566|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.0||||0.985|TWO_SIDED|95.0|0.63|1.59|||Regression, Logistic|OR=1.00||For the primary outcome measure, a repeated-measures logistic regression model was used to analyze the odds of a negative urine cannabinoid test as an indicator of abstinence across all 12 weeks of treatment. A generalized estimating equations (GEEs) were used to adjust for this correlation with multiple samples per participant. The model for the primary analysis included the main effect of treatment, main effect of time, site effects, effect of smoking tobacco, and timeXtreatment interaction.||1.59|0.63|0.985
72407234|NCT01502644|144322948|OTHER||Mean Difference (Net)|18.0||||0.01|TWO_SIDED|95.0|3.7|32.2|||Linear Mixed Modeling|Group, group×week, average baseline pain, and opioid use at baseline were entered as fixed effects using an autoregressive covariance structure.||||32.2|3.7|0.01
72407235|NCT02388997|144322966|SUPERIORITY|||||||0.59|||||||2-sample t-test with unequal variences|||||||0.59
72526868|NCT04806165|144583875|SUPERIORITY|To improve the quality of the imputations, gender, age, and race were included as auxiliary variables. We generated ten imputed datasets with the predictive mean matching method and pooled coefficients, degrees of freedom, and standard errors with Rubin's (1987) rules. As a sensitivity analysis, we also ran the same models using full information maximum likelihood to handle missing data.|Regression (Beta) Coefficient|-0.06|STANDARD_ERROR_OF_MEAN|0.03||0.026|TWO_SIDED|||||We computed both unstandardized (B) and standardized (ß) coefficients to indicate effect sizes. As suggested by Fey et al. (2023), we interpreted absolute ß values below 0.2 as small, between 0.2 and 0.5 as medium, and greater than 0.5 as large.|Linear Mixed Effects Model|The linear mixed effects models incorporated a random intercept to accommodate the correlation of repeated measures within participants.||Analyses were conducted to determine the interaction effects of time since intervention and each of the four chatbot components. This analysis explores the interaction effects of time and the motivational interviewing (MI) component on participant attitudes toward change for concerns related to their eating, weight, and/or shape concerns since engagement with the intervention.||||.026
72526869|NCT04806165|144583875|SUPERIORITY|To improve the quality of the imputations, gender, age, and race were included as auxiliary variables. We generated ten imputed datasets with the predictive mean matching method and pooled coefficients, degrees of freedom, and standard errors with Rubin's (1987) rules. As a sensitivity analysis, we also ran the same models using full information maximum likelihood to handle missing data.|Regression (Beta) Coefficient|0.02|STANDARD_ERROR_OF_MEAN|0.03||0.465|TWO_SIDED|||||We computed both unstandardized (B) and standardized (ß) coefficients to indicate effect sizes. As suggested by Fey et al. (2023), we interpreted absolute ß values below 0.2 as small, between 0.2 and 0.5 as medium, and greater than 0.5 as large.|Linear Mixed Effects Model|The linear mixed effects models incorporated a random intercept to accommodate the correlation of repeated measures within participants.||Analyses were conducted to determine the interaction effects of time since intervention and each of the four chatbot components. This analysis explores the interaction effects of time and the personalized recommendation (PR) component on participant attitudes toward change for concerns related to their eating, weight, and/or shape concerns since engagement with the intervention.||||.465
72542573|NCT03877237|144614993|SUPERIORITY||Hodges-Lehmann median diff. vs placebo|4.17||||0.05842|TWO_SIDED|95.0|0.03|8.33||KCCQ-PLS was tested at the alpha level of 0.04990 because KCCQ-TSS had a statistically significant p-value, in accordance with the pre-specified testing strategy.|Rank ANCOVA|Model includes baseline rank of outcome variable as a covariate, treatment group as a factor, and is stratified by T2DM status at randomization.||"For the primary efficacy endpoint KCCQ-PLS, the following hypothesis was tested at significant level of 0.04990~* H0: m(r(A)) = m(r(C)) versus~* H1: m(r(A)) ≠ m(r(C)) Where H0 and H1 are the null and alternative hypotheses, respectively, and m(r(A)) and m(r(C)) represent the median of the ranked changes in the primary efficacy endpoint, KCCQ-PLS, from baseline to week 16, among patients receiving dapagliflozin (Active) and placebo (Control) treatment, respectively."||8.33|0.03|0.05842
72571378|NCT02393248|144671579|SUPERIORITY|||||||0.2841|||||||ANOVA|1-factor ANOVA of log-transformed, dose-normalized data (factor = dose)||||||0.2841
72571379|NCT02393248|144671579|SUPERIORITY|||||||0.3042|||||||ANOVA|1-factor ANOVA of log-transformed, dose-normalized data (factor = dose)||||||0.3042
72571380|NCT02393248|144671579|SUPERIORITY|||||||0.1259|||||||ANOVA|1-factor ANOVA of log-transformed, dose-normalized data (factor = dose)||||||0.1259
72571381|NCT02393248|144671579|SUPERIORITY|||||||0.8214|||||||ANOVA|1-factor ANOVA of log-transformed, dose-normalized data (factor = dose)||||||0.8214
72571382|NCT02393248|144671579|SUPERIORITY|||||||0.4315|||||||ANOVA|1-factor ANOVA of log-transformed, dose-normalized data (factor = dose)||||||0.4315
72571383|NCT02393248|144671579|SUPERIORITY|||||||0.2595|||||||ANOVA|1-factor ANOVA of log-transformed, dose-normalized data (factor = dose)||||||0.2595
72571384|NCT02393248|144671583|SUPERIORITY|||||||0.8577|||||||ANOVA|1-factor ANOVA of log-transformed, dose-normalized data (factor = dose)||||||0.8577
72571385|NCT02393248|144671583|SUPERIORITY|||||||0.7238|||||||ANOVA|1-factor ANOVA of log-transformed, dose-normalized data (factor = dose)||||||0.7238
72571386|NCT02393248|144671583|SUPERIORITY|||||||0.5923|||||||ANOVA|1-factor ANOVA of log-transformed, dose-normalized data (factor = dose)||||||0.5923
72407236|NCT02388997|144322967|SUPERIORITY|||||||0.58|||||||2-sample t-test with unequal variances|||||||0.58
72407237|NCT02388997|144322968|SUPERIORITY|||||||0.87|||||||2-sample t-test with unequal variances|||||||0.87
72625324|NCT01098747|144780088|SUPERIORITY_OR_OTHER||Difference in proportion|2.74||||0.303|TWO_SIDED|95.0|-3.01|8.49||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||0.5 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||8.49|-3.01|0.303
72526870|NCT04806165|144583875|SUPERIORITY|To improve the quality of the imputations, gender, age, and race were included as auxiliary variables. We generated ten imputed datasets with the predictive mean matching method and pooled coefficients, degrees of freedom, and standard errors with Rubin's (1987) rules. As a sensitivity analysis, we also ran the same models using full information maximum likelihood to handle missing data.|Regression (Beta) Coefficient|-0.02|STANDARD_ERROR_OF_MEAN|0.03||0.536|TWO_SIDED|||||We computed both unstandardized (B) and standardized (ß) coefficients to indicate effect sizes. As suggested by Fey et al. (2023), we interpreted absolute ß values below 0.2 as small, between 0.2 and 0.5 as medium, and greater than 0.5 as large.|Linear Mixed Effects Model|The linear mixed effects models incorporated a random intercept to accommodate the correlation of repeated measures within participants.||Analyses were conducted to determine the interaction effects of time since intervention and each of the four chatbot components. This analysis explores the interaction effects of time and the psychoeducation (PE) component on participant attitudes toward change for concerns related to their eating, weight, and/or shape concerns since engagement with the intervention.||||.536
72526871|NCT04806165|144583875|SUPERIORITY|To improve the quality of the imputations, gender, age, and race were included as auxiliary variables. We generated ten imputed datasets with the predictive mean matching method and pooled coefficients, degrees of freedom, and standard errors with Rubin's (1987) rules. As a sensitivity analysis, we also ran the same models using full information maximum likelihood to handle missing data.|Regression (Beta) Coefficient|0.06|STANDARD_ERROR_OF_MEAN|0.03||0.049|TWO_SIDED|||||We computed both unstandardized (B) and standardized (ß) coefficients to indicate effect sizes. As suggested by Fey et al. (2023), we interpreted absolute ß values below 0.2 as small, between 0.2 and 0.5 as medium, and greater than 0.5 as large|Linear Mixed Effects Model|The linear mixed effects models incorporated a random intercept to accommodate the correlation of repeated measures within participants.||Analyses were conducted to determine the interaction effects of time since intervention and each of the four chatbot components. This analysis explores the interaction effects of time and the repeated administration (RA) component on participant attitudes toward change for concerns related to their eating, weight, and/or shape concerns since engagement with the intervention.||||.049
72526872|NCT01901809|144583877|SUPERIORITY||Mean Difference (Net)|11.4|STANDARD_ERROR_OF_MEAN|4.7||0.018|TWO_SIDED|95.0|2.0|20.8|||t-test, 2 sided|||||20.8|2.0|0.018
72526873|NCT01901809|144583878|SUPERIORITY||Mean Difference (Net)|-4.8|STANDARD_ERROR_OF_MEAN|4.8||0.33|TWO_SIDED|95.0|-14.4|4.9|||t-test, 2 sided|||||4.9|-14.4|0.33
72526874|NCT02776904|144583886|OTHER|||||||0.0003||||||Adjustment with Tukey-Kramer|ANOVA|3 DF||Repeated measures ANOVA compared pre-season scores to post-season, end of the school year and pre-season year 2 for Visual Memory||||0.0003
72526875|NCT02776904|144583886|OTHER|||||||0.0281||||||Adjusted for multiple comparisons using Tukey-Kramer|ANOVA|DF 3||Repeated measures ANOVA compared pre-season scores to post-season, end of the school year and pre-season year 2 for Verbal memory||||0.0281
72526876|NCT02776904|144583886|OTHER|||||||0.0035||||||Adjusted for multiple comparisons|ANOVA|DF 3||Repeated measures ANOVA compared pre-season scores to post-season, end of the school year and pre-season year 2 for Visual Motor composite||||0.0035
72526877|NCT02776904|144583887|OTHER|||||||0.2637||||||Adjusted for multiple comparisons using Tukey-Kramer|ANOVA|||Repeated measures ANOVA compared pre-season scores to post-season, end of the school year and pre-season year 2 for Reaction Time||||0.2637
72526878|NCT02776904|144583888|OTHER||||||<|0.001||||||Used Tukey's Adjustment|ANOVA|||Descriptive analysis, including means and standard deviations was used to summarize all participant data. Velocity was normalized to leg length. Normality was tested and assumed for all measured gait parameters for healthy athletes. A two-way repeated measure analyses of variance (ANOVA) was used to explore the impact of walk status and sex on gait velocity for healthy athletes. Adjusted using Tukey's post hoc method for the pairwise comparisons (0.05 threshold for significance)||||<0.001
72526879|NCT02776904|144583889|OTHER|Normality was tested and assumed for all measured gait parameters. A two-way repeated measure analyses of variance (ANOVA) was used to explore the impact of walk status and sex on gait parameters of step length. Adjusted using Tukey's post hoc method for the pairwise comparisons (0.05 threshold for significance).|||||<|0.0001|||||||ANOVA|Tukey's post hoc method for the pair wise comparisons between walk status and sex for step length.||||||< 0.0001
72526880|NCT02776904|144583890|OTHER|Normality was tested and assumed for all measured gait parameters. A two-way repeated measure analyses of variance (ANOVA) was used to explore the impact of walk status and sex on percent of gait cycle in DLS.|||||<|0.0001|||||||ANOVA|Tukey's post hoc method for the pairwise comparisons with p\<.05.||||||< 0.0001
72526881|NCT02776904|144583891|OTHER|Normality was tested and assumed for all measured gait parameters. A two-way repeated measure analyses of variance (ANOVA) was used to explore the impact of walk status and sex on percent of gait cycle in SLS.|||||<|0.0001|||||||ANOVA|Tukey's post hoc method for pairwise comparison between walk status and sex for %GC in SLS.||||||< 0.0001
72526882|NCT02776904|144583892|OTHER||||||>|0.05|||||||ANOVA|||||||>0.05
72526883|NCT02776904|144583893|OTHER||||||>|0.05|||||||ANOVA|||||||>0.05
72526884|NCT02776904|144583894|OTHER||||||>|0.05|||||||ANOVA|||||||>0.05
72526885|NCT04657003|144583896|SUPERIORITY||LSMean Mean Difference (Net)|-10.1|||<|0.001|TWO_SIDED|95.0|-11.5|-8.8|||Mixed Models Analysis|||||-8.8|-11.5|<0.001
72526886|NCT04657003|144583896|SUPERIORITY||LSMean Mean Difference (Net)|-12.4|||<|0.001|TWO_SIDED|95.0|-13.7|-11.0|||Mixed Models Analysis|||||-11.0|-13.7|<0.001
72526887|NCT04657003|144583897|SUPERIORITY||Odds Ratio (OR)|10.75|||<|0.001|TWO_SIDED|95.0|7.3|15.84|||Regression, Logistic|||||15.84|7.30|<0.001
72526888|NCT04657003|144583897|SUPERIORITY||Odds Ratio (OR)|15.28|||<|0.001|TWO_SIDED|95.0|10.08|23.14|||Regression, Logistic|||||23.14|10.08|<0.001
72407238|NCT02388997|144322969|SUPERIORITY|||||||0.55|||||||2-sample t-test with unequal variances|||||||0.55
72526889|NCT04657003|144583898|SUPERIORITY||Odds Ratio (OR)|20.94|||<|0.001|TWO_SIDED|95.0|13.06|33.58|||Regression, Logistic|||||33.58|13.06|<0.001
72526890|NCT04657003|144583898|SUPERIORITY||Odds Ratio (OR)|27.5|||<|0.001|TWO_SIDED|95.0|17.04|44.39|||Regression, Logistic|||||44.39|17.04|<0.001
72526891|NCT04657003|144583899|SUPERIORITY||Odds Ratio (OR)|28.38|||<|0.001|TWO_SIDED|95.0|13.81|58.31|||Regression, Logistic|||||58.31|13.81|<0.001
72526892|NCT04657003|144583899|SUPERIORITY||Odds Ratio (OR)|43.6|||<|0.001|TWO_SIDED|95.0|21.2|89.67|||Regression, Logistic|||||89.67|21.20|<0.001
72526893|NCT04657003|144583900|SUPERIORITY||Odds Ratio (OR)|28.54|||<|0.001|TWO_SIDED|95.0|9.73|83.73|||Regression, Logistic|||||83.73|9.73|<0.001
72526894|NCT04657003|144583900|SUPERIORITY||Odds Ratio (OR)|49.68|||<|0.001|TWO_SIDED|95.0|17.03|144.94|||Regression, Logistic|||||144.94|17.03|<0.001
72526895|NCT04657003|144583901|SUPERIORITY||LSMean Mean Difference (Net)|-10.3|||<|0.001|TWO_SIDED|95.0|-11.7|-8.8|||Mixed Models Analysis|||||-8.8|-11.7|<0.001
72526896|NCT04657003|144583901|SUPERIORITY||LSMean Mean Difference (Net)|-12.4|||<|0.001|TWO_SIDED|95.0|-13.8|-11.0|||Mixed Models Analysis|||||-11.0|-13.8|<0.001
72526897|NCT04657003|144583902|SUPERIORITY||LSMean Mean Difference (Net)|-3.7|||<|0.001|TWO_SIDED|95.0|-4.2|-3.2|||Mixed Models Analysis|||||-3.2|-4.2|<0.001
72526898|NCT04657003|144583902|SUPERIORITY||LSMean Mean Difference (Net)|-4.5|||<|0.001|TWO_SIDED|95.0|-5.0|-4.0|||Mixed Models Analysis|||||-4.0|-5.0|<0.001
72526899|NCT04657003|144583903|SUPERIORITY||LSMean Mean Difference (Net)|-1.97|||<|0.001|TWO_SIDED|95.0|-2.15|-1.8|||Mixed Models Analysis|||||-1.80|-2.15|<0.001
72526900|NCT04657003|144583903|SUPERIORITY||LSMean Mean Difference (Net)|-2.06|||<|0.001|TWO_SIDED|95.0|-2.24|-1.88|||Mixed Models Analysis|||||-1.88|-2.24|<0.001
72526901|NCT04657003|144583904|SUPERIORITY||Odds Ratio (OR)|28.01|||<|0.001|TWO_SIDED|95.0|17.21|45.59|||Regression, Logistic|||||45.59|17.21|<0.001
72526902|NCT04657003|144583904|SUPERIORITY||Odds Ratio (OR)|34.19|||<|0.001|TWO_SIDED|95.0|20.27|57.67|||Regression, Logistic|||||57.67|20.27|<0.001
72526903|NCT04657003|144583905|SUPERIORITY||Odds Ratio (OR)|42.11|||<|0.001|TWO_SIDED|95.0|25.61|69.26|||Regression, Logistic|||||69.26|25.61|<0.001
72526904|NCT04657003|144583905|SUPERIORITY||Odds Ratio (OR)|58.67|||<|0.001|TWO_SIDED|95.0|34.29|100.37|||Regression, Logistic|||||100.37|34.29|<0.001
72526905|NCT04657003|144583906|SUPERIORITY||Odds Ratio (OR)|42.55|||<|0.001|TWO_SIDED|95.0|20.46|88.5|||Regression, Logistic|||||88.50|20.46|<0.001
72526906|NCT04657003|144583906|SUPERIORITY||Odds Ratio (OR)|54.3|||<|0.001|TWO_SIDED|95.0|26.0|113.38|||Regression, Logistic|||||113.38|26.00|<0.001
72526907|NCT04657003|144583907|SUPERIORITY||LSMean Mean Difference (Net)|-46.79|||<|0.001|TWO_SIDED|95.0|-52.67|-40.91|||Mixed Models Analysis|||||-40.91|-52.67|<0.001
72526908|NCT04657003|144583907|SUPERIORITY||LSMean Mean Difference (Net)|-49.25|||<|0.001|TWO_SIDED|95.0|-55.18|-43.33|||Mixed Models Analysis|||||-43.33|-55.18|<0.001
72526909|NCT04657003|144583908|SUPERIORITY||LSMean Mean Difference (Net)|-7.8|||<|0.001|TWO_SIDED|95.0|-9.2|-6.4|||Mixed Models Analysis|||||-6.4|-9.2|<0.001
72526910|NCT04657003|144583908|SUPERIORITY||LSMean Mean Difference (Net)|-10.4|||<|0.001|TWO_SIDED|95.0|-11.8|-8.9|||Mixed Models Analysis|||||-8.9|-11.8|<0.001
72526911|NCT04657003|144583909|SUPERIORITY||Estimate Difference|-4.61|||<|0.001|TWO_SIDED|95.0|-7.11|-2.03|||Mixed Models Analysis|||||-2.03|-7.11|<0.001
72526912|NCT04657003|144583910|SUPERIORITY||Estimate Difference|-3.36||||0.112|TWO_SIDED|95.0|-7.36|0.81|||Mixed Models Analysis|||||0.81|-7.36|0.112
72526913|NCT04657003|144583911|SUPERIORITY||Estimate Difference|7.02|||<|0.001|TWO_SIDED|95.0|4.4|9.71|||Mixed Models Analysis|||||9.71|4.40|<0.001
72526914|NCT04657003|144583912|SUPERIORITY||Estimate Difference|-23.3|||<|0.001|TWO_SIDED|95.0|-27.5|-18.9|||Mixed Models Analysis|||||-18.9|-27.5|<0.001
72526915|NCT04657003|144583913|SUPERIORITY||Estimate Difference|-24.2|||<|0.001|TWO_SIDED|95.0|-28.6|-19.6|||Mixed Models Analysis|||||-19.6|-28.6|<0.001
72526916|NCT04657003|144583914|SUPERIORITY||Estimate Difference|-8.74|||<|0.001|TWO_SIDED|95.0|-12.04|-5.32|||Mixed Models Analysis|||||-5.32|-12.04|<0.001
72526917|NCT04657003|144583915|SUPERIORITY||Estimate Difference|-23.61|||<|0.001|TWO_SIDED|95.0|-28.62|-18.24|||Mixed Models Analysis|||||-18.24|-28.62|<0.001
72526918|NCT04657003|144583916|SUPERIORITY||LSMean Mean Difference (Net)|-6.2|||<|0.001|TWO_SIDED|95.0|-8.0|-4.4|||Mixed Models Analysis|||||-4.4|-8.0|<0.001
72526919|NCT04657003|144583917|SUPERIORITY||LSMean Mean Difference (Net)|-2.4|||<|0.001|TWO_SIDED|95.0|-3.5|-1.3|||Mixed Models Analysis|||||-1.3|-3.5|<0.001
72526920|NCT04657003|144583918|SUPERIORITY||Estimate Difference|-17.6|||<|0.001|TWO_SIDED|95.0|-25.5|-8.9|||Mixed Models Analysis|||||-8.9|-25.5|<0.001
72526921|NCT04657003|144583918|SUPERIORITY||Estimate Difference|-30.2|||<|0.001|TWO_SIDED|95.0|-37.0|-22.7|||Mixed Models Analysis|||||-22.7|-37.0|<0.001
72526922|NCT04657003|144583919|SUPERIORITY||LSMean Mean Difference (Net)|1.8||||0.001|TWO_SIDED|95.0|0.7|2.9|||ANCOVA|||||2.9|0.7|0.001
72526923|NCT04657003|144583919|SUPERIORITY||LSMean Mean Difference (Net)|2.3|||<|0.001|TWO_SIDED|95.0|1.1|3.4|||ANCOVA|||||3.4|1.1|<0.001
72526924|NCT04657003|144583920|SUPERIORITY||LSMean Difference (Net)|6.9|||<|0.001|TWO_SIDED|95.0|4.1|9.7|||ANCOVA|||||9.7|4.1|<0.001
72526925|NCT04657003|144583920|SUPERIORITY||LSMean Difference (Net)|7.8|||<|0.001|TWO_SIDED|95.0|5.0|10.7|||ANCOVA|||||10.7|5.0|<0.001
72526926|NCT01736176|144583922|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Mixed-effect Repeated Measures (MMRM)|MMRM model included the fixed effects of study site and visit, with baseline score as a covariate, and the baseline-by-visit interaction.||The primary null hypothesis was no change in least-square (LS) mean, calculated using a mixed-effect repeated measures model (MMRM), for NMSS total score from baseline to Week 12. The statistical test was two-sided and the null hypothesis was rejected at the significance level of α = 0.050.||||< 0.001
72526927|NCT01736176|144583926|SUPERIORITY_OR_OTHER_LEGACY|||||||0.004|||||||Mixed-effect Repeated Measures (MMRM)|MMRM model included the fixed effects of study site and visit, with baseline score as a covariate, and the baseline-by-visit interaction.||||||0.004
72526928|NCT02274311|144583994|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||"Measures of central tendency (mean) and variability (range and/or SD) were used to describe numeric variables. Paired Student's t test was used to verify the mean differences between dependent normally distributed variables. Wilcoxon sign test was performed to non-normally distributed dependent variables.~Asignificance level of 5%was adopted for all statistical tests (P \<.05)."||||< 0.05
72571387|NCT02393248|144671583|SUPERIORITY|||||||0.7634|||||||ANOVA|1-factor ANOVA of log-transformed, dose-normalized data (factor = dose)||||||0.7634
72526929|NCT02477800|144583997|SUPERIORITY||Difference from Placebo|0.11||||0.225|TWO_SIDED|95.0|-0.469|0.403|||MMRM Model|||Adjusted mean for each treatment group (Placebo, BIIB037 Low Dose, BIIB037 High Dose), difference with Placebo, 95% confidence interval and p-value at each time point were based on an MMRM model, with change from baseline in CDR-SB as dependent variable and with fixed effects of treatment group, categorical visit, treatment-by-visit interaction, baseline CDR-SB, baseline CDR-SB by visit interaction, baseline MMSE, AD symptomatic medication use at baseline, region, and laboratory ApoE status.||0.403|-0.469|0.2250
72526930|NCT02477800|144583997|SUPERIORITY||Difference from late start group|0.03||||0.833|TWO_SIDED|95.0|-0.262|0.326|||MMRM Model|||Adjusted mean for each treatment group (Placebo, BIIB037 Low Dose, BIIB037 High Dose), difference with Placebo, 95% confidence interval and p-value at each time point were based on an MMRM model, with change from baseline in CDR-SB as dependent variable and with fixed effects of treatment group, categorical visit, treatment-by-visit interaction, baseline CDR-SB, baseline CDR-SB by visit interaction, baseline MMSE, AD symptomatic medication use at baseline, region, and laboratory ApoE status.||0.326|-0.262|0.8330
72526931|NCT02477800|144583998|SUPERIORITY||Difference from Placebo|0.2||||0.4795|TWO_SIDED|95.0|-0.35|0.74|||MMRM Model|||Adjusted mean for each treatment group (Placebo, BIIB037 Low Dose, BIIB037 High Dose), difference from Placebo, 95% confidence interval and p-value at each time point were based on an MMRM model, with change from baseline in MMSE as dependent variable and with fixed effects of treatment group, categorical visit, treatment-by-visit interaction, baseline MMSE, baseline MMSE by visit interaction, AD symptomatic medication use at baseline, region, and laboratory ApoE status.||0.74|-0.35|0.4795
72526932|NCT02477800|144583998|SUPERIORITY||Difference from Placebo|-0.1||||0.8106|TWO_SIDED|95.0|-0.62|0.49|||MMRM Model|||Adjusted mean for each treatment group (Placebo, BIIB037 Low Dose, BIIB037 High Dose), difference from Placebo, 95% confidence interval and p-value at each time point were based on an MMRM model, with change from baseline in MMSE as dependent variable and with fixed effects of treatment group, categorical visit, treatment-by-visit interaction, baseline MMSE, baseline MMSE by visit interaction, AD symptomatic medication use at baseline, region, and laboratory ApoE status.||0.49|-0.62|0.8106
72526933|NCT02477800|144583999|SUPERIORITY||Difference from Placebo|-0.583||||0.2536|TWO_SIDED|95.0|-1.5835|0.4181|||MMRM Model|||Adjusted mean for each treatment group (Placebo,BIIB037 Low Dose,BIIB037 High Dose),difference with Placebo, 95% confidence interval and p-value at each time point were based on an MMRM model, with change from baseline in ADAS-Cog 13 as dependent variable and with fixed effects of treatment group,categorical visit,treatment-by-visit interaction,baseline ADAS-Cog 13,baseline ADAS-Cog 13 by visit interaction,baseline MMSE,AD symptomatic medication use at baseline,region,and laboratory ApoE status.||0.4181|-1.5835|0.2536
72526934|NCT02477800|144583999|SUPERIORITY||Difference from Placebo|-0.588||||0.2578|TWO_SIDED|95.0|-1.6067|0.4309|||MMRM Model|||Adjusted mean for each treatment group (Placebo,BIIB037 Low Dose,BIIB037 High Dose),difference with Placebo, 95% confidence interval and p-value at each time point were based on an MMRM model, with change from baseline in ADAS-Cog 13 as dependent variable and with fixed effects of treatment group,categorical visit,treatment-by-visit interaction,baseline ADAS-Cog 13,baseline ADAS-Cog 13 by visit interaction,baseline MMSE,AD symptomatic medication use at baseline,region,and laboratory ApoE status.||0.4309|-1.6067|0.2578
72526935|NCT02477800|144584000|SUPERIORITY||Difference from Placebo|0.7||||0.1225|TWO_SIDED|95.0|-0.19|1.64|||MMRM Model|||Adjusted mean for each group (Placebo, BIIB037 Low Dose, BIIB037 High Dose), difference with Placebo,95% confidence interval and p-value at each time point were based on an MMRM model, with change from baseline in ADCS-ADL-MCI as dependent variable and with fixed effects of treatment group,categorical visit,treatment-by-visit interaction, baseline ADCS-ADL-MCI, baseline ADCS-ADL-MCI by visit interaction, baseline MMSE AD symptomatic medication use at baseline,region, and laboratory ApoE status.||1.64|-0.19|0.1225
72526936|NCT02477800|144584000|SUPERIORITY||Difference from late start group|0.7||||0.1506|TWO_SIDED|95.0|-0.25|1.61|||MMRM Model|||Adjusted mean for each group (Placebo, BIIB037 Low Dose, BIIB037 High Dose), difference with Placebo,95% confidence interval and p-value at each time point were based on an MMRM model, with change from baseline in ADCS-ADL-MCI as dependent variable and with fixed effects of treatment group,categorical visit,treatment-by-visit interaction, baseline ADCS-ADL-MCI, baseline ADCS-ADL-MCI by visit interaction, baseline MMSE AD symptomatic medication use at baseline,region, and laboratory ApoE status.||1.61|-0.25|0.1506
72571388|NCT02393248|144671583|SUPERIORITY|||||||0.5749|||||||ANOVA|1-factor ANOVA of log-transformed, dose-normalized data (factor = dose)||||||0.5749
72571389|NCT02393248|144671583|SUPERIORITY|||||||0.6877|||||||ANOVA|1-factor ANOVA of log-transformed, dose-normalized data (factor = dose)||||||0.6877
72571390|NCT02393248|144671587|SUPERIORITY|||||||0.143|||||||ANOVA|crossover ANOVA of log-transformed data||||||0.143
72526937|NCT01948518|144584011|SUPERIORITY_OR_OTHER||||||=|0.3|TWO_SIDED||||||t-test, 2 sided|||Assuming 15% change in absolute value of DLCO representing a significant clinical difference and a standard deviation of 17.4% in normal nonsmoking individuals \[Miller A, Thornton JC, Warshaw R, et al. Am Rev Respir Dis. 1983;127 (suppl 3):270-277.\], 13 subjects needed to be studied to reject the null hypothesis when there is no significant difference between DLCO measurements before and after sildenafil, with power 0.8 and type I error probability 0.05 (SAS 9.2, SAS Institute Inc., Cary, NC)||||=0.30
72526938|NCT01948518|144584012|SUPERIORITY_OR_OTHER||||||=|0.63|||||||t-test, 2 sided|||The average 6 minute walk distance at baseline was 1195±407 feet. After oral administration of sildenafil, 6 minute walk distance was 1214±383 feet (p=0.63).||||=0.63
72526939|NCT00958191|144584018|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Sign test|||Change in HHS from pre-op to 1 year||||<0.0001
72571391|NCT02393248|144671588|SUPERIORITY|||||||0.0013|||||||ANOVA|crossover ANOVA of log-transformed data||||||0.0013
72571392|NCT02393248|144671589|SUPERIORITY|||||||0.319|||||||ANOVA|crossover ANOVA of log-transformed data||||||0.319
72571393|NCT02393248|144671590|SUPERIORITY|||||||0.128|||||||ANOVA|crossover ANOVA of log-transformed data||||||0.128
72571394|NCT02393248|144671591|SUPERIORITY|||||||0.305|||||||ANOVA|crossover ANOVA of log-transformed data||||||0.305
72571395|NCT02393248|144671592|SUPERIORITY|||||||0.305|||||||ANOVA|crossover ANOVA of log-transformed data||||||0.305
72407239|NCT02388997|144322970|SUPERIORITY|||||||0.6|||||||2-sample t-test with unequal variances|||||||0.6
72571396|NCT02393248|144671593|SUPERIORITY|||||||0.772|||||||ANOVA|crossover ANOVA of log-transformed data||||||0.772
72571397|NCT01971970|144671635|EQUIVALENCE|The number of genes with a 1.5 fold change (FDR value ≤ 0.05; paired t-test) from week 0 to week 8 were assessed for pediatric IBD or adult IBD patients.|||||<|0.05|||||||Paired t-test,FDR 1.5fold,FDRvalue≤ 0.05|||The number of genes with a 1.5 fold change (FDR value ≤ 0.05; paired t-test) from week 0 to week 8 were assessed for pediatric IBD or adult IBD patients.||||< 0.05
72571398|NCT01971970|144671636|OTHER|||||||0.2616||||||Kaplan-Meier curve comparing the percentage of children and adults on continued anti-TNF therapy over the course of study duration|gehan-breslow-wilcoxon test|||Kaplan-Meier curves were produced by dividing the population in the following groups i) paediatric versus adult patients.These groups were used to statistically compare the proportions of patients over time regarding continued anti-TNF therapy, reflecting maintenance of response at 12 and 18 months.||||0.2616
72571399|NCT01971970|144671637|OTHER|||||||0.0177||||||Kaplan-Meier curve comparing the percentage of children and adults with therapy intensification over the course of study duration|gehan-breslow-wilcoxon test|||Kaplan-Meier curves were produced by dividing the population in the following groups i) paediatric versus adult patients.These groups were used to statistically compare the proportions of patients over time regarding the escalation of anti-TNF therapy (dose increase above 5 mg/kg and/or interval shortening to less than 8 weeks)||||0.0177
72571400|NCT04561375|144671663|SUPERIORITY||Proportional odds ratio|0.37||||0.067|TWO_SIDED|95.0|0.13|1.07|||proportional odds logistic regression|In the analysis, 100 µg and 150 µg were merged as one level since too few cases used 150 µg.||||1.07|0.13|0.067
72571401|NCT04561375|144671664|SUPERIORITY||Mean Difference (Final Values)|10.0||||0.147|TWO_SIDED|97.5|-5.8|26.0|||Regression, Linear|||||26|-5.8|0.147
72571402|NCT04561375|144671665|SUPERIORITY||Mean Difference (Final Values)|8.4||||0.463|TWO_SIDED|97.5|-18.0|34.0|||Regression, Linear|||||34|-18|0.463
72571403|NCT04561375|144671666|SUPERIORITY||Median Difference (Final Values)|-13.0||||0.032|TWO_SIDED|95.0|-25.0|0.0|||Wilcoxon (Mann-Whitney)|||||0|-25|0.032
72571404|NCT00117325|144671691|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.335||||0.05|TWO_SIDED|95.0|-0.67|0.0|||ANCOVA|Analysis of covariance (ANCOVA) method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD Week 1-4 analysis.||0.00|-0.67|0.050
72571405|NCT00117325|144671692|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.393||||0.027|TWO_SIDED|95.0|-0.74|-0.05||Week 1-4|ANCOVA|ANCOVA method was used adjusting for baseline iTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD Week 1-4 analysis.||-0.05|-0.74|0.027
72571406|NCT00117325|144671693|SUPERIORITY_OR_OTHER|||||||0.184|||||||Regression, Logistic|logistic regression adjusting for age, gender, investigator, and treatment.||Placebo versus Fluticasone Furoate 110 mcg QD up to Week 4 analysis.|Effectiveness of study medication for relieving non-allergic rhinitis symptoms over the entire treatment period (Total response) was analyzed.|||0.184
72571407|NCT00117325|144671694|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.348||||0.051|TWO_SIDED|95.0|-0.7|0.0|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD Week 1-4 analysis.||0.00|-0.70|0.051
72571408|NCT00117325|144671695|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.304||||0.076|TWO_SIDED|95.0|-0.64|0.03|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD up to Week 4 analysis||0.03|-0.64|0.076
72571409|NCT00117325|144671696|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.51||||0.093|TWO_SIDED|95.0|-9.77|0.75|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD Week 1-4 analysis.||0.75|-9.77|0.093
72571410|NCT00117325|144671697|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-6.372||||0.023|TWO_SIDED|95.0|-11.8|-0.9|||ANCOVA|ANCOVA method was used adjusting for baseline iTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD Week 1-4 analysis.||-0.90|-11.8|0.023
72571411|NCT00117325|144671698|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.118||||0.061|TWO_SIDED|95.0|-0.24|0.01|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for Rhinorrhea||0.01|-0.24|0.061
72571412|NCT00117325|144671698|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.124||||0.061|TWO_SIDED|95.0|-0.25|0.01|||ANCOVA|||Placebo versus Fluticasone Furoate 110 mcg QD for Nasal Congestion||0.01|-0.25|0.061
72571413|NCT00117325|144671698|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.095||||0.138|TWO_SIDED|95.0|-0.22|0.03|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for post-nasal drip||0.03|-0.22|0.138
72571414|NCT00117325|144671699|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.113||||0.087|TWO_SIDED|95.0|-0.24|0.02|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for Rhinorrhea||0.02|-0.24|0.087
72571415|NCT00117325|144671699|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.164||||0.015|TWO_SIDED|95.0|-0.3|-0.03|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for nasal congestion||-0.03|-0.30|0.015
72571416|NCT00117325|144671699|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.112||||0.106|TWO_SIDED|95.0|-0.25|0.02|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for post-nasal drip||0.02|-0.25|0.106
72571417|NCT00117325|144671700|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.132||||0.048|TWO_SIDED|95.0|-0.26|0.0|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for rhinorrhea||-0.00|-0.26|0.048
72625325|NCT01098747|144780088|SUPERIORITY_OR_OTHER||Difference in proportion|27.24|||<|0.001|TWO_SIDED|95.0|18.14|36.34||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1 hour: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||36.34|18.14|<0.001
72526940|NCT00958191|144584018|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Sign test|||Change in HHS from pre-op to 3 years||||<0.0001
72526941|NCT00958191|144584018|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||Change in HHS from pre-op to 5 years||||<0.0001
72526942|NCT00958191|144584019|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Sign test|||Change in Harris Hip Pain Score from pre-op to 1 year||||<0.0001
72571418|NCT00117325|144671700|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.124||||0.076|TWO_SIDED|95.0|-0.26|0.01|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for Nasal congestion||0.01|-0.26|0.076
72407240|NCT02388997|144322972|SUPERIORITY|||||||0.037||||||The p value is based on the fold change (ratio) of the geometric means of the time (days) to peak symptoms among asthmatics in the omalizumab/placebo treatment groups.|2-sample t-test on the log scale|||||||0.037
72407241|NCT00207142|144322980|NON_INFERIORITY_OR_EQUIVALENCE|Efficacy at Week 48 on the Switch Arm was considered to be non-inferior to the Continuation Arm if the lower limit of the 95% Confidence Interval was greater than -15%.|Difference in proportions|2.9||||||95.0|-9.8|15.5|||Normal approximation|||The planned sample size of 178 randomized subjects (89 on each regimen) provides at least 80% power to demonstrate that the response rate on ATV is within a 15% margin of the response rate on ATV/RTV assuming: a 2-sided 95% confidence interval for the difference in response rate between treatment regimens (switch-continuation); a response rate of 85% in both the Continuation and Switch regimens; a margin of -15% for the difference in response rates between treatment regimens.||15.5|-9.8|
72526943|NCT00958191|144584019|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Sign test|||Change in Harris Hip Pain Score from pre-op to 3 years||||<0.0001
72526944|NCT00958191|144584019|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Sign test|||Change in Harris Hip Pain Score from pre-op to 5 years||||<0.0001
72571419|NCT00117325|144671700|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.093||||0.164|TWO_SIDED|95.0|-0.22|0.04|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg for post-nasal drip||0.04|-0.22|0.164
72407242|NCT00207142|144322981|SUPERIORITY_OR_OTHER||Difference in Proportions|5.0||||||95.0|-6.0|16.1|||Normal Approximation|||||16.1|-6.0|
72526945|NCT00958191|144584020|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Sign test|||Change in Harris Hip ROM score from pre-op to 1 year||||<0.0001
72526946|NCT00958191|144584020|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Sign test|||Change in Harris Hip ROM score from pre-op to 3 years||||<0.0001
72526947|NCT00958191|144584020|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Sign test|||Change in Harris Hip ROM score from pre-op to 5 years||||<0.0001
72526948|NCT00958191|144584021|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Sign test|||Change in SF-12 Phyiscal Component Score from preop to 1 year||||<0.0001
72407243|NCT00207142|144322982|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.97||||||95.0|0.5|1.88|||Cox Proportional Hazards Model|||Covariate in the model: treatment regimen.||1.88|0.50|
72526949|NCT00958191|144584021|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||Change in SF-12 Phyiscal Component Score from preop to 3 year||||<0.0001
72526950|NCT00958191|144584021|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Sign test|||Change in SF-12 Phyiscal Component Score from preop to 5 year||||<0.0001
72526951|NCT00958191|144584021|SUPERIORITY_OR_OTHER|||||||0.0242|||||||Sign test|||Change in SF-12 Mental Component Score from preop to 1 year||||0.0242
72526952|NCT00958191|144584021|SUPERIORITY_OR_OTHER|||||||0.0247|||||||Sign test|||Change in SF-12 Mental Component Score from preop to 3 year||||0.0247
72526953|NCT00958191|144584021|SUPERIORITY_OR_OTHER|||||||0.1372|||||||Sign test|||Change in SF-12 Mental Component Score from preop to 5 year||||0.1372
72526954|NCT00958191|144584022|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Sign test|||Change in LEAS Score from preop to 1 year||||<0.0001
72526955|NCT00958191|144584022|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Sign test|||Change in LEAS Score from preop to 3 year||||<0.0001
72526956|NCT00958191|144584022|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||Change in LEAS Score from preop to 5 year||||<0.0001
72526957|NCT00598806|144584102|SUPERIORITY||Odds Ratio (OR)|0.76||||0.1094|TWO_SIDED|95.0|0.55|1.06|||Cochran-Mantel-Haenszel|||||1.06|0.55|0.1094
72526958|NCT00598806|144584103|SUPERIORITY||Hazard Ratio (HR)|0.81||||0.1038|TWO_SIDED|95.0|0.63|1.04|||Log Rank|||||1.04|0.63|0.1038
72526959|NCT00170846|144584119|SUPERIORITY_OR_OTHER||Difference in LS means|1.1241||||0.6332|TWO_SIDED|95.0|-3.5077|5.7559|||ANCOVA|||||5.7559|-3.5077|0.6332
72526960|NCT00170846|144584119|SUPERIORITY_OR_OTHER||Difference in LS means|0.5933||||0.7943|TWO_SIDED|95.0|-3.8815|5.0682|||ANCOVA|||||5.0682|-3.8815|0.7943
72526961|NCT02607865|144584160|NON_INFERIORITY|This hypothesis was controlled for multiplicity. Results are based on the data from the in-trial observation period. The estimated treatment effect includes the effect of any rescue medication and any effect after premature trial product discontinuation (treatment policy estimand). A value of 0.3% (the non-inferiority margin) was added to imputed values at week 26 for the oral semaglutide treatment arm only.|Mean treatment difference|-0.5|||<|0.0001|TWO_SIDED|95.0|-0.6|-0.4||Unadjusted two-sided p-value for test of no difference from the non-inferiority margin (non-inferiority). The non-inferiority margin was 0.3%.|Pattern mixture model||Oral semaglutide 14 mg - Sitagliptin 100 mg|The analysis was based on a pattern mixture model using multiple imputation to handle missing week 26 data, assuming that data were missing at random within the groups used for imputation. The imputed data sets were analysed using an analysis of covariance (ANCOVA) model with treatment, strata, and region as categorical fixed effects and baseline HbA1c value as covariate for each of the 1000 imputed complete data sets, and pooled by Rubin's rule to draw inference.||-0.4|-0.6|< 0.0001
72542574|NCT03877237|144614994|SUPERIORITY||Hodges-Lehmann median diff. vs placebo|3.2||||0.68626|TWO_SIDED|95.0|-6.5|13.0||To account for multiplicity, a pre-specified testing strategy was followed to control the overall type I error rate.|Rank ANCOVA|Model includes baseline rank of outcome variable as a covariate, treatment group as a factor, and is stratified by T2DM status at randomization.||"For the primary efficacy endpoint 6MWD, the following hypothesis was tested using the significance level 0.00010:~H0: m(r(A)) = m(r(C)) versus H1: m(r(A)) ≠ m(r(C)) Where H0 and H1 are the null and alternative hypotheses, respectively, and m(r(A)) and m(r(C)) represent the median of the ranked changes in the primary efficacy endpoint, 6MWD, from baseline to week 16, among patients receiving dapagliflozin (Active) and placebo (Control) treatment, respectively."||13.0|-6.5|0.68626
72526962|NCT02607865|144584160|SUPERIORITY|This hypothesis was controlled for multiplicity. Results are based on the data from the in-trial observation period. The estimated treatment effect includes the effect of any rescue medication and any effect after premature trial product discontinuation (treatment policy estimand).|Mean treatment difference|-0.5|||<|0.0001|TWO_SIDED|95.0|-0.6|-0.4||Unadjusted two-sided p-value for test of no difference from 0 (superiority).|Pattern mixture model||Oral semaglutide 14 mg - Sitagliptin 100 mg|The analysis was based on a pattern mixture model using multiple imputation to handle missing week 26 data, assuming that data were missing at random within the groups used for imputation. The imputed data sets were analysed using an ANCOVA model with treatment, strata, and region as categorical fixed effects and baseline HbA1c value as covariate for each of the 1000 imputed complete data sets, and pooled by Rubin's rule to draw inference.||-0.4|-0.6|< 0.0001
72526963|NCT02607865|144584160|NON_INFERIORITY|This hypothesis was controlled for multiplicity. Results are based on the data from the in-trial observation period. The estimated treatment effect includes the effect of any rescue medication and any effect after premature trial product discontinuation (treatment policy estimand). A value of 0.3% (the non-inferiority margin) was added to imputed values at week 26 for the oral semaglutide treatment arm only.|Mean treatment difference|-0.2|||<|0.0001|TWO_SIDED|95.0|-0.4|-0.1||Unadjusted two-sided p-value for test of no difference from the non-inferiority margin (non-inferiority). The non-inferiority margin was 0.3%.|Pattern mixture model||Oral semaglutide 7 mg - Sitagliptin 100 mg|The analysis was based on a pattern mixture model using multiple imputation to handle missing week 26 data, assuming that data were missing at random within the groups used for imputation. The imputed data sets were analysed using an ANCOVA model with treatment, strata, and region as categorical fixed effects and baseline HbA1c value as covariate for each of the 1000 imputed complete data sets, and pooled by Rubin's rule to draw inference.||-0.1|-0.4|< 0.0001
72526964|NCT02607865|144584160|SUPERIORITY|This hypothesis was controlled for multiplicity. Results are based on the data from the in-trial observation period. The estimated treatment effect includes the effect of any rescue medication and any effect after premature trial product discontinuation (treatment policy estimand).|Mean treatment difference|-0.3|||<|0.0001|TWO_SIDED|95.0|-0.4|-0.1||Unadjusted two-sided p-value for test of no difference from 0 (superiority).|Pattern mixture model||Oral semaglutide 7 mg - Sitagliptin 100 mg|The analysis was based on a pattern mixture model using multiple imputation to handle missing week 26 data, assuming that data were missing at random within the groups used for imputation. The imputed data sets were analysed using an ANCOVA model with treatment, strata, and region as categorical fixed effects and baseline HbA1c value as covariate for each of the 1000 imputed complete data sets, and pooled by Rubin's rule to draw inference.||-0.1|-0.4|< 0.0001
72526965|NCT02607865|144584160|NON_INFERIORITY|This hypothesis was controlled for multiplicity. Results are based on the data from the in-trial observation period. The estimated treatment effect includes the effect of any rescue medication and any effect after premature trial product discontinuation (treatment policy estimand). A value of 0.3% (the non-inferiority margin) was added to imputed values at week 26 for the oral semaglutide treatment arm only.|Mean treatment difference|0.2|||=|0.0856|TWO_SIDED|95.0|0.1|0.3||Unadjusted two-sided p-value for test of no difference from the non-inferiority margin (non-inferiority). The non-inferiority margin was 0.3%.|Pattern mixture model||Oral semaglutide 3 mg - Sitagliptin 100 mg|The analysis was based on a pattern mixture model using multiple imputation to handle missing week 26 data, assuming that data were missing at random within the groups used for imputation. The imputed data sets were analysed using an ANCOVA model with treatment, strata, and region as categorical fixed effects and baseline HbA1c value as covariate for each of the 1000 imputed complete data sets, and pooled by Rubin's rule to draw inference.||0.3|0.1|= 0.0856
72526966|NCT02607865|144584160|SUPERIORITY|This hypothesis was not controlled for multiplicity, since the non-inferiority test of change in HbA1c for oral semaglutide 3 mg versus sitagliptin 100 mg could not be confirmed. Results are based on the data from the in-trial observation period. The estimated treatment effect includes the effect of any rescue medication and any effect after premature trial product discontinuation (treatment policy estimand).|Mean treatment difference|0.2|||=|0.008|TWO_SIDED|95.0|0.0|0.3||Unadjusted two-sided p-value for test of no difference from 0 (superiority).|Pattern mixture model||Oral semaglutide 3 mg - Sitagliptin 100 mg. If the mean treatment difference is non-negative, the superiority hypothesis of oral semaglutide 3 mg vs sitagliptin 100 mg will never be confirmed irrespective of the observed two-sided p-value.|The analysis was based on a pattern mixture model using multiple imputation to handle missing week 26 data, assuming that data were missing at random within the groups used for imputation. The imputed data sets were analysed using an ANCOVA model with treatment, strata, and region as categorical fixed effects and baseline HbA1c value as covariate for each of the 1000 imputed complete data sets, and pooled by Rubin's rule to draw inference.||0.3|0.0|= 0.0080
72526967|NCT02607865|144584160|NON_INFERIORITY|This hypothesis was not controlled for multiplicity. Results are based on the data from the on-treatment without rescue medication observation period. The estimated treatment effect excludes the effect of any rescue medication and any effect after premature trial product discontinuation (hypothetical estimand).|Mean treatment difference|-0.6|||<|0.0001|TWO_SIDED|95.0|-0.7|-0.5||Unadjusted two-sided p-value for test of no difference from the non-inferiority margin (non-inferiority). The non-inferiority margin was 0.3%.|MMRM||Oral semaglutide 14 mg - Sitagliptin 100 mg|The analysis was based on a mixed model for repeated measurements (MMRM) that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 26. The independent effects were treatment, strata and region as categorical fixed effects and the baseline HbA1c value as a covariate, all nested within visit, and an unstructured residual covariance matrix.||-0.5|-0.7|<0.0001
72571420|NCT00117325|144671701|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.096||||0.136|TWO_SIDED|95.0|-0.22|0.03|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for Rhinorrhea||0.03|-0.22|0.136
72571421|NCT00117325|144671701|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.111||||0.1||95.0|-0.24|0.02|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for nasal congestion||0.02|-0.24|0.100
72407244|NCT00207142|144322983|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.84||||||95.0|0.37|1.9|||Cox Proportional Hazards Model|||Covariate in the model: treatment regimen||1.90|0.37|
72407245|NCT00207142|144322984|SUPERIORITY_OR_OTHER||Difference in means at Week 48|7.0||||||95.0|-38.0|53.0|||Normal approximation|||||53|-38|
72407246|NCT01559311|144323004|SUPERIORITY_OR_OTHER|||||||0.1734|||||||Wilcoxon (Mann-Whitney)|||"* H01: μ LVEF, 1= μ LVEF, 2a vs H1a: μ LVEF, 1 \< μ LVEF, 2a~* Where μ LVEF, 1 is the mean of LVEF at month 12 in DDDR Gp.~* μ LVEF, 2a is the mean of LVEF at month 12 in CRT-P ON Gp,"||||0.1734
72407247|NCT01559311|144323004|SUPERIORITY_OR_OTHER|||||||0.1439|||||||Wilcoxon (Mann-Whitney)|||"* H03: μ LVEF, 1= μ LVEF, 2b vs H1a: μ LVEF, 1 \< μ LVEF, 2b~* Where μ LVEF, 1 is the mean of LVEF at month 12 in DDDR Gp.~* μ LVEF, 2b is the mean of LVEF at month 12 in the CRT-P OFF Gp"||||0.1439
72407248|NCT01559311|144323005|SUPERIORITY_OR_OTHER|||||||0.6276|||||||Wilcoxon (Mann-Whitney)|||"* H02: μ LVESV, 1 = μ LVESV, 2a vs H1b: μ LVESV, 1 \> μ LVESV, 2a~* Where, μLVESV, 1 is the mean of LVESV at month 12 in the DDDR Group,~* μLVESV, 2a is the mean of LVESV at month 12 in the CRT-P ON group"||||0.6276
72526968|NCT02607865|144584160|SUPERIORITY|This hypothesis was not controlled for multiplicity. Results are based on the data from the on-treatment without rescue medication observation period. The estimated treatment effect excludes the effect of any rescue medication and any effect after premature trial product discontinuation (hypothetical estimand).|Mean treatment difference|-0.6|||<|0.0001|TWO_SIDED|95.0|-0.7|-0.5||Unadjusted two-sided p-value for test of no difference from 0 (superiority).|MMRM||Oral semaglutide 14 mg - Sitagliptin 100 mg|The analysis was based on a MMRM that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 26. The independent effects were treatment, strata and region as categorical fixed effects and the baseline HbA1c value as a covariate, all nested within visit, and an unstructured residual covariance matrix.||-0.5|-0.7|<0.0001
72526969|NCT02607865|144584160|NON_INFERIORITY|This hypothesis was not controlled for multiplicity. Results are based on the data from the on-treatment without rescue medication observation period. The estimated treatment effect excludes the effect of any rescue medication and any effect after premature trial product discontinuation (hypothetical estimand).|Mean treatment difference|-0.3|||<|0.0001|TWO_SIDED|95.0|-0.4|-0.2||Unadjusted two-sided p-value for test of no difference from the non-inferiority margin (non-inferiority). The non-inferiority margin was 0.3%.|MMRM||Oral semaglutide 7 mg - Sitagliptin 100 mg|The analysis was based on a MMRM that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 26. The independent effects were treatment, strata and region as categorical fixed effects and the baseline HbA1c value as a covariate, all nested within visit, and an unstructured residual covariance matrix.||-0.2|-0.4|<0.0001
72526970|NCT02607865|144584160|SUPERIORITY|This hypothesis was not controlled for multiplicity. Results are based on the data from the on-treatment without rescue medication observation period. The estimated treatment effect excludes the effect of any rescue medication and any effect after premature trial product discontinuation (hypothetical estimand).|Mean treatment difference|-0.3|||<|0.0001|TWO_SIDED|95.0|-0.4|-0.2||Unadjusted two-sided p-value for test of no difference from 0 (superiority).|MMRM||Oral semaglutide 7 mg - Sitagliptin 100 mg|The analysis was based on a MMRM that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 26. The independent effects were treatment, strata and region as categorical fixed effects and the baseline HbA1c value as a covariate, all nested within visit, and an unstructured residual covariance matrix.||-0.2|-0.4|<0.0001
72526971|NCT02607865|144584160|NON_INFERIORITY|This hypothesis was not controlled for multiplicity. Results are based on the data from the on-treatment without rescue medication observation period. The estimated treatment effect excludes the effect of any rescue medication and any effect after premature trial product discontinuation (hypothetical estimand).|Mean treatment difference|0.2|||=|0.3851|TWO_SIDED|95.0|0.1|0.4||Unadjusted two-sided p-value for test of no difference from the non-inferiority margin (non-inferiority). The non-inferiority margin was 0.3%.|MMRM||Oral semaglutide 3 mg - Sitagliptin 100 mg|The analysis was based on a MMRM that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 26. The independent effects were treatment, strata and region as categorical fixed effects and the baseline HbA1c value as a covariate, all nested within visit, and an unstructured residual covariance matrix.||0.4|0.1|=0.3851
72542575|NCT03877237|144614995|SUPERIORITY||Hodges-Lehmann median diff. vs placebo|-0.16||||0.19748|TWO_SIDED|95.0|-0.55|0.22||Total time spent in LVPA was not tested for statistical significance and the p-value is considered nominal because the test for 6MWD was not statistically significant.|Rank ANCOVA|Model includes baseline rank of outcome variable as a covariate, treatment group as a factor, and is stratified by T2DM status at randomization.||"For the secondary efficacy endpoint, total time spent in LVPA, the testing hypothesis is~* H0: m(r(A)) = m(r(C)) versus~* H1: m(r(A)) ≠ m(r(C)) Where H0 and H1 are the null and alternative hypotheses, respectively, and m(r(A)) and m(r(C)) represent the median of the ranked changes in secondary efficacy endpoint, total time spent in LVPA, from baseline to End of study among patients receiving dapagliflozin (Active) and placebo (Control) treatment, respectively."||0.22|-0.55|0.19748
72571422|NCT00117325|144671701|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.111||||0.1|TWO_SIDED|95.0|-0.24|0.02|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for post-nasal drip||0.02|-0.24|0.100
72407249|NCT01559311|144323005|SUPERIORITY_OR_OTHER|||||||0.5871|||||||Wilcoxon (Mann-Whitney)|||"* H04: μ LVESV, 1 = μ LVESV, 2b vs H1b: μ LVESV, 1 \> μ LVESV, 2b~* Where, μLVESV, 1 is the mean of LVESV at month 12 in the DDDR Group,~* and μLVESV, 2b is the mean of LVESV at month 12 in CRT-P OFF group."||||0.5871
72407250|NCT00835497|144323006|NON_INFERIORITY_OR_EQUIVALENCE|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Test/Ref Ratio of LS Means x 100|86.5||||||90.0|81.8|91.6|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||91.6|81.8|
72407251|NCT00835497|144323007|NON_INFERIORITY_OR_EQUIVALENCE|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Test/Ref Ratio of LS Means x 100|97.0||||||90.0|94.2|99.9|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||99.9|94.2|
72407252|NCT00835497|144323008|NON_INFERIORITY_OR_EQUIVALENCE|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Test/Ref Ratio of LS Means x 100|97.0||||||90.0|94.2|99.8|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||99.8|94.2|
72571423|NCT00117325|144671702|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.45||||0.011|TWO_SIDED|95.0|-0.8|-0.1|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM iTNSS at Day 1||-0.10|-0.80|0.011
72571424|NCT00117325|144671702|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.325||||0.089|TWO_SIDED|95.0|-0.7|0.05|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM iTNSS at Day 2||0.05|-0.70|0.089
72526972|NCT02607865|144584160|OTHER|This hypothesis was not controlled for multiplicity. Results are based on the data from the on-treatment without rescue medication observation period. The estimated treatment effect excludes the effect of any rescue medication and any effect after premature trial product discontinuation (hypothetical estimand).|Mean treatment difference|0.2|||<|0.0001|TWO_SIDED|95.0|0.1|0.4||Unadjusted two-sided p-value for test of no difference from 0 (superiority).|MMRM||Oral semaglutide 3 mg - Sitagliptin 100 mg. If the mean treatment difference is non-negative, the superiority hypothesis of oral semaglutide 3 mg vs sitagliptin 100 mg will never be confirmed irrespective of the observed two-sided p-value.|The analysis was based on a MMRM that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 26. The independent effects were treatment, strata and region as categorical fixed effects and the baseline HbA1c value as a covariate, all nested within visit, and an unstructured residual covariance matrix.||0.4|0.1|<0.0001
72526973|NCT02607865|144584161|SUPERIORITY|This hypothesis was controlled for multiplicity. Results are based on the data from the in-trial observation period. The estimated treatment effect includes the effect of any rescue medication and any effect after premature trial product discontinuation (treatment policy estimand).|Mean treatment difference|-2.5|||<|0.0001|TWO_SIDED|95.0|-3.0|-2.0||Unadjusted two-sided p-value for test of no difference from 0 (superiority).|Pattern mixture model||Oral semaglutide 14 mg - Sitagliptin 100 mg|The analysis was based on a pattern mixture model using multiple imputation to handle missing week 26 data, assuming that data were missing at random within the groups used for imputation. The imputed data sets were analysed using an ANCOVA model with treatment, strata, and region as categorical fixed effects and baseline body weight value as covariate for each of the 1000 imputed complete data sets, and pooled by Rubin's rule to draw inference.||-2.0|-3.0|< 0.0001
72526974|NCT02607865|144584161|SUPERIORITY|This hypothesis was controlled for multiplicity. Results are based on the data from the in-trial observation period. The estimated treatment effect includes the effect of any rescue medication and any effect after premature trial product discontinuation (treatment policy estimand).|Mean treatment difference|-1.6|||<|0.0001|TWO_SIDED|95.0|-2.0|-1.1||Unadjusted two-sided p-value for test of no difference from 0 (superiority).|Pattern mixture model||Oral semaglutide 7 mg - Sitagliptin 100 mg|The analysis was based on a pattern mixture model using multiple imputation to handle missing week 26 data, assuming that data were missing at random within the groups used for imputation. The imputed data sets were analysed using an ANCOVA model with treatment, strata, and region as categorical fixed effects and baseline body weight value as covariate for each of the 1000 imputed complete data sets, and pooled by Rubin's rule to draw inference.||-1.1|-2.0|< 0.0001
72526975|NCT02607865|144584161|SUPERIORITY|This hypothesis was not controlled for multiplicity, since the non-inferiority test of change in HbA1c for oral semaglutide 3 mg versus sitagliptin 100 mg could not be confirmed. Results are based on the data from the in-trial observation period. The estimated treatment effect includes the effect of any rescue medication and any effect after premature trial product discontinuation (treatment policy estimand).|Mean treatment difference|-0.6|||=|0.0185|TWO_SIDED|95.0|-1.1|-0.1||Unadjusted two-sided p-value for test of no difference from 0 (superiority).|Pattern mixture model||Oral semaglutide 3 mg - Sitagliptin 100 mg|The analysis was based on a pattern mixture model using multiple imputation to handle missing week 26 data, assuming that data were missing at random within the groups used for imputation. The imputed data sets were analysed using an ANCOVA model with treatment, strata, and region as categorical fixed effects and baseline body weight value as covariate for each of the 1000 imputed complete data sets, and pooled by Rubin's rule to draw inference.||-0.1|-1.1|= 0.0185
72542576|NCT00382291|144615033|SUPERIORITY_OR_OTHER|||||||0.2106||95.0|||||Kruskal-Wallis|||Data were analyzed using two-sided Kruskal-Wallis test with level of significance = .05. Null hypothesis was that there were no group differences. The maximum CGI-SA obtained over course of study was the outcome measure.||||.2106
72542577|NCT00382291|144615034|SUPERIORITY_OR_OTHER|||||||0.8831|TWO_SIDED|95.0|||||ANCOVA|||Data were analyzed using ANCOVA modeling with two-sided testing and level of significance = .05. The dependent variable was last measured CY-BOCS score, the independent variable was randomized group assignment and the covariate was the CY-BOCS score at baseline. The null hypothesis was that there were no group differences.||||.8831
72571425|NCT00117325|144671702|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.393||||0.052|TWO_SIDED|95.0|-0.79|0.0|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM iTNSS at Day 3||0.00|-0.79|0.052
72571426|NCT00117325|144671702|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.262||||0.187|TWO_SIDED|95.0|-0.65|0.13|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM iTNSS at Day 4||0.13|-0.65|0.187
72571427|NCT00117325|144671702|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.298||||0.164|TWO_SIDED|95.0|-0.72|0.12|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM iTNSS at Day 5||0.12|-0.72|0.164
72571428|NCT00117325|144671702|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.573||||0.008|TWO_SIDED|95.0|-1.0|-0.15|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM iTNSS at Day 6||-0.15|-1.00|0.008
72526976|NCT02607865|144584161|SUPERIORITY|This hypothesis was not controlled for multiplicity. Results are based on the data from the on-treatment without rescue medication observation period. The estimated treatment effect excludes the effect of any rescue medication and any effect after premature trial product discontinuation (hypothetical estimand).|Mean treatment difference|-2.6|||<|0.0001|TWO_SIDED|95.0|-3.1|-2.1||Unadjusted two-sided p-value for test of no difference from 0 (superiority).|MMRM||Oral semaglutide 14 mg - Sitagliptin 100 mg|The analysis was based on a MMRM that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 26. The independent effects were treatment, strata and region as categorical fixed effects and the baseline body weight value as a covariate, all nested within visit, and an unstructured residual covariance matrix.||-2.1|-3.1|<0.0001
72526977|NCT02607865|144584161|SUPERIORITY|This hypothesis was not controlled for multiplicity. Results are based on the data from the on-treatment without rescue medication observation period. The estimated treatment effect excludes the effect of any rescue medication and any effect after premature trial product discontinuation (hypothetical estimand).|Mean treatment difference|-1.5|||<|0.0001|TWO_SIDED|95.0|-2.0|-1.1||Unadjusted two-sided p-value for test of no difference from 0 (superiority).|MMRM||Oral semaglutide 7 mg - Sitagliptin 100 mg|The analysis was based on a MMRM that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 26. The independent effects were treatment, strata and region as categorical fixed effects and the baseline body weight value as a covariate, all nested within visit, and an unstructured residual covariance matrix.||-1.1|-2.0|<0.0001
72526978|NCT02607865|144584161|SUPERIORITY|This hypothesis was not controlled for multiplicity. Results are based on the data from the on-treatment without rescue medication observation period. The estimated treatment effect excludes the effect of any rescue medication and any effect after premature trial product discontinuation (hypothetical estimand).|type Mean treatment difference|-0.5|||=|0.0257|TWO_SIDED|95.0|-1.0|-0.1||Unadjusted two-sided p-value for test of no difference from 0 (superiority).|MMRM||Oral semaglutide 3 mg - Sitagliptin 100 mg|The analysis was based on a MMRM that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 26. The independent effects were treatment, strata and region as categorical fixed effects and the baseline body weight value as a covariate, all nested within visit, and an unstructured residual covariance matrix.||-0.1|-1.0|=0.0257
72526979|NCT02607865|144584182|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|1.34|||=|0.0063|TWO_SIDED|95.0|1.09|1.65||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox||Oral semaglutide 3 mg / Sitagliptin 100 mg|Time to initiation of additional anti-diabetic medication was analysed using a Cox proportional hazards model with treatment, strata, and region as categorical fixed effects and baseline HbA1c as covariate. Withdrawal for any reason or lost to follow-up contributed to the analysis as events (initiation of additional anti-diabetic medication). Censoring time was one day before planned end of treatment.||1.65|1.09|=0.0063
72526980|NCT02607865|144584182|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|0.77|||=|0.0221|TWO_SIDED|95.0|0.61|0.96||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox||Oral semaglutide 7 mg / Sitagliptin 100 mg|Time to initiation of additional anti-diabetic medication was analysed using a Cox proportional hazards model with treatment, strata, and region as categorical fixed effects and baseline HbA1c as covariate. Withdrawal for any reason or lost to follow-up contributed to the analysis as events (initiation of additional anti-diabetic medication). Censoring time was one day before planned end of treatment.||0.96|0.61|=0.0221
72526981|NCT02607865|144584182|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|0.53|||<|0.0001|TWO_SIDED|95.0|0.41|0.68||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox||Oral semaglutide 14 mg / Sitagliptin 100 mg|Time to initiation of additional anti-diabetic medication was analysed using a Cox proportional hazards model with treatment, strata, and region as categorical fixed effects and baseline HbA1c as covariate. Withdrawal for any reason or lost to follow-up contributed to the analysis as events (initiation of additional anti-diabetic medication). Censoring time was one day before planned end of treatment.||0.68|0.41|<0.0001
72526982|NCT02607865|144584183|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|1.33|||=|0.016|TWO_SIDED|95.0|1.05|1.68||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox||Oral semaglutide 3 mg / Sitagliptin 100 mg|Time to initiation of rescue medication was analysed using a Cox proportional hazards model with treatment, strata, and region as categorical fixed effects and baseline HbA1c as covariate. Censoring time was one day before last day on trial product.||1.68|1.05|=0.0160
72526983|NCT02607865|144584183|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|0.66|||=|0.0022|TWO_SIDED|95.0|0.51|0.86||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox||Oral semaglutide 7 mg / Sitagliptin 100 mg|Time to initiation of rescue medication was analysed using a Cox proportional hazards model with treatment, strata, and region as categorical fixed effects and baseline HbA1c as covariate. Censoring time was one day before last day on trial product.||0.86|0.51|=0.0022
72526984|NCT02607865|144584183|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|0.31|||<|0.0001|TWO_SIDED|95.0|0.22|0.43||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox||Oral semaglutide 14 mg / Sitagliptin 100 mg|Time to initiation of rescue medication was analysed using a Cox proportional hazards model with treatment, strata, and region as categorical fixed effects and baseline HbA1c as covariate. Censoring time was one day before last day on trial product.||0.43|0.22|<0.0001
72526985|NCT01714336|144584219|SUPERIORITY_OR_OTHER|||||||0.75|TWO_SIDED||||||Regression, Logistic|||||||0.75
72542578|NCT01681771|144615052|SUPERIORITY|||||||0.21|||||||ANCOVA|ANCOVA analysis comparing PHQ-9 mean values at 9 weeks follow-up between the I-CBT and discussion group and adjusting for PHQ-9 values baseline||||||0.21
72542579|NCT03154333|144615053|OTHER||Risk Ratio (RR)|1.01||||0.9666|TWO_SIDED|95.0|0.63|1.62|||Cochran-Mantel-Haenszel|Log transformation normalized the Risk Ratio (RR) estimates; the Standard Error (SE) of the estimate was obtained from confidence limits for the RR.||||1.62|0.63|0.9666
72542580|NCT03154333|144615054|OTHER||Risk Ratio (RR)|1.53||||0.2861|TWO_SIDED|95.0|0.41|3.28|||Cochran-Mantel-Haenszel|Log transformation normalized the Risk Ratio (RR) estimates; the Standard Error (SE) of the estimate was obtained from confidence limits for the RR.||||3.28|0.41|0.2861
72571429|NCT00117325|144671702|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.376||||0.082|TWO_SIDED|95.0|-0.8|0.05|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM iTNSS at Day 7||0.05|-0.80|0.082
72571430|NCT00117325|144671702|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.231||||0.296|TWO_SIDED|95.0|-0.67|0.2|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM iTNSS at Day 8||0.20|-0.67|0.296
72571431|NCT00117325|144671702|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.191||||0.383|TWO_SIDED|95.0|-0.62|0.24|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM iTNSS at Day 9||0.24|-0.62|0.383
72571432|NCT00117325|144671702|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.464||||0.048|TWO_SIDED|95.0|-0.92|0.0|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM iTNSS at Day 10||-0.00|-0.92|0.048
72571433|NCT00117325|144671702|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.172||||0.469|TWO_SIDED|95.0|-0.64|0.29|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM iTNSS at Day 11||0.29|-0.64|0.469
72571434|NCT00117325|144671702|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.34||||0.151|TWO_SIDED|95.0|-0.8|0.12|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM iTNSS at Day 12||0.12|-0.80|0.151
72571435|NCT00117325|144671702|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.344||||0.145|TWO_SIDED|95.0|-0.81|0.12|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM iTNSS at Day 13||0.12|-0.81|0.145
72571436|NCT00117325|144671702|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.235||||0.297|TWO_SIDED|95.0|-0.68|0.21|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM iTNSS at Day 14||0.21|-0.68|0.297
72571437|NCT00117325|144671702|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.38||||0.094|TWO_SIDED|95.0|-0.82|0.07|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM iTNSS at Day 15||0.07|-0.82|0.094
72571438|NCT00117325|144671702|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.43||||0.064|TWO_SIDED|95.0|-0.89|0.03|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM iTNSS at Day 16||0.03|-0.89|0.064
72571439|NCT00117325|144671702|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.563||||0.019|TWO_SIDED|95.0|-1.03|-0.09|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM iTNSS at Day 17||-0.09|-1.03|0.019
72571440|NCT00117325|144671702|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.457||||0.044|TWO_SIDED|95.0|-0.9|-0.01|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM iTNSS at Day 18||-0.01|-0.90|0.044
72571441|NCT00117325|144671702|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.633||||0.007|TWO_SIDED|95.0|-1.09|-0.17|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM iTNSS at Day 19||-0.17|-1.09|0.007
72571442|NCT00117325|144671702|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.222||||0.348|TWO_SIDED|95.0|-0.69|0.24|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM iTNSS at Day 20||0.24|-0.69|0.348
72571443|NCT00117325|144671702|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.281||||0.243|TWO_SIDED|95.0|-0.76|0.19|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM iTNSS at Day 21||0.19|-0.76|0.243
72571444|NCT00117325|144671702|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.595||||0.014|TWO_SIDED|95.0|-1.07|-0.12|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM iTNSS at Day 22||-0.12|-1.07|0.014
72571445|NCT00117325|144671702|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.474||||0.055|TWO_SIDED|95.0|-0.96|0.01|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM iTNSS at Day 23||0.01|-0.96|0.055
72571446|NCT00117325|144671702|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.464||||0.062|TWO_SIDED|95.0|-0.95|0.02|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM iTNSS at Day 24||0.02|-0.95|0.062
72571447|NCT00117325|144671702|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.43||||0.079|TWO_SIDED|95.0|-0.91|0.05|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM iTNSS at Day 25||0.05|-0.91|0.079
72571448|NCT00117325|144671702|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.576||||0.019|TWO_SIDED|95.0|-1.06|-0.1|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM iTNSS at Day 26||-0.10|-1.06|0.019
72571449|NCT00117325|144671702|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.48||||0.056|TWO_SIDED|95.0|-0.97|0.01|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM iTNSS at Day 27||0.01|-0.97|0.056
72625326|NCT01098747|144780088|SUPERIORITY_OR_OTHER||Difference in proportion|6.66||||0.217|TWO_SIDED|95.0|-4.31|17.63||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1 hour: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||17.63|-4.31|0.217
72625327|NCT01098747|144780088|SUPERIORITY_OR_OTHER||Difference in proportion|41.16|||<|0.001|TWO_SIDED|95.0|31.2|51.12||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1.5 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||51.12|31.20|<0.001
72526986|NCT01756833|144584224|SUPERIORITY||Mean Difference (Final Values)|0.0|STANDARD_DEVIATION|0.035||0.71|TWO_SIDED|95.0|-0.07|0.07||Two prespecified interim analyses for efficacy performed when 1/3 \& 2/3 of primary outcome available, significance level, 1-sided, alpha=.0005. Final analysis 1-sided, alpha=.024. Futility analysis performed when \~2/3 primary outcome was available.|ANCOVA on normal scores|||"Null hypothesis: normal score of MTD at follow-up adjusted for baseline and gender in doxycycline assigned patients - normal score of MTD at follow-up adjusted for baseline and gender in placebo assigned patients = 0.~Sample size: The criterion (alpha) set for statistical significance was 1-sided .025; use of this level means that the inference from the test result will be the same as the inference from 2-sided testing at the .05 significance level."|For the primary analysis, diameters at baseline were ranked from smallest to largest (ranks 1-254). At the 2-year follow-up, ranks 1 through 225 were assigned to the diameters of surviving patients with no aneurysm repair (with missing values estimated by multiple imputation), ranks 226 through 247 were assigned to surviving patients who underwent aneurysm repair (in order of longest to shortest time from randomization to repair), and ranks 248 through 254 were assigned to patients who died (in order of longest to shortest time from randomization to death). Each rank was converted to a normal score corresponding to the value on the standard normal curve (z score) of its percentile among all 254 ranks. The primary analysis was based on linear regression of the change in normal scores from baseline to 2 years. Independent variables were baseline normal score, sex, and a dichotomous variable for the randomly assigned treatment group (0 for placebo, 1 for doxycycline).|0.07|-0.07|0.71
72526987|NCT01766401|144584232|SUPERIORITY||Least Squares Mean Difference|-1.5||||0.0438|TWO_SIDED|95.0|-2.96|-0.04|||MMRM|||||-0.04|-2.96|0.0438
72407253|NCT00835497|144323009|NON_INFERIORITY_OR_EQUIVALENCE|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Test/Ref Ratio of LS Means x 100|88.9||||||90.0|83.5|94.6|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||94.6|83.5|
72526988|NCT01766401|144584233|SUPERIORITY||Least Squares Mean Difference|-1.41||||0.0868|TWO_SIDED|95.0|-3.02|0.2|||MMRM|||||0.20|-3.02|0.0868
72526989|NCT01523613|144584234|SUPERIORITY|||||||0.262|||||||Fisher Exact|||||||0.262
72407254|NCT00835497|144323010|NON_INFERIORITY_OR_EQUIVALENCE|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Test/Ref Ratio of LS Means x 100|92.7||||||90.0|88.4|97.1|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||97.1|88.4|
72526990|NCT01523613|144584235|SUPERIORITY|||||||0.523|||||||Fisher Exact|||||||0.523
72526991|NCT01523613|144584236|SUPERIORITY|||||||0.1|||||||Fisher Exact|||||||0.100
72526992|NCT01700140|144584295|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Fisher Exact|||||||1.0000
72526993|NCT01700140|144584295|SUPERIORITY_OR_OTHER|||||||0.2284|||||||Fisher Exact|||||||0.2284
72526994|NCT01700140|144584295|SUPERIORITY_OR_OTHER|||||||0.2549|||||||Cochran-Armitage test|||||||0.2549
72526995|NCT01700140|144584296|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||||||1.0000
72526996|NCT01700140|144584296|SUPERIORITY_OR_OTHER|||||||0.1527|||||||Fisher Exact|||||||0.1527
72526997|NCT01700140|144584296|SUPERIORITY_OR_OTHER|||||||0.1864|||||||Cochran-Armitage test|||||||0.1864
72526998|NCT01700140|144584297|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.918||||0.8361|TWO_SIDED|95.0|0.266|3.172|||Generalized Wilcoxon test|||||3.172|0.266|0.8361
72526999|NCT01700140|144584297|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.423||||0.0724|TWO_SIDED|95.0|0.144|1.237|||Generalized Wilcoxon test|||||1.237|0.144|0.0724
72527000|NCT01700140|144584298|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.213||||0.6466|TWO_SIDED|95.0|0.616|2.388|||Generalized Wilcoxon test|||||2.388|0.616|0.6466
72527001|NCT01700140|144584298|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.828||||0.2701|TWO_SIDED|95.0|0.566|1.21|||Generalized Wilcoxon test|||||1.210|0.566|0.2701
72527002|NCT01700140|144584299|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Fisher Exact|||Statistical analysis for complete control rate after the first irradiation||||1.0000
72527003|NCT01700140|144584299|SUPERIORITY_OR_OTHER|||||||0.1051|TWO_SIDED||||||Fisher Exact|||Statistical analysis for complete control rate after the first irradiation||||0.1051
72527004|NCT01700140|144584299|SUPERIORITY_OR_OTHER|||||||0.4856|TWO_SIDED||||||Fisher Exact|||Statistical analysis for complete control rate after the second irradiation||||0.4856
72527005|NCT01700140|144584299|SUPERIORITY_OR_OTHER|||||||0.1047|TWO_SIDED||||||Fisher Exact|||Statistical analysis for complete control rate after the second irradiation||||0.1047
72527006|NCT01700140|144584299|SUPERIORITY_OR_OTHER|||||||0.1617|TWO_SIDED||||||Fisher Exact|||Statistical analysis for complete control rate after the third irradiation||||0.1617
72527007|NCT01700140|144584299|SUPERIORITY_OR_OTHER|||||||0.3099|TWO_SIDED||||||Fisher Exact|||Statistical analysis for complete control rate after the third irradiation||||0.3099
72527008|NCT01700140|144584300|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Fisher Exact|||Statistical analysis for complete response rate after the first irradiation||||1.0000
72527009|NCT01700140|144584300|SUPERIORITY_OR_OTHER|||||||0.1051|TWO_SIDED||||||Fisher Exact|||Statistical analysis for complete response rate after the first irradiation||||0.1051
72527010|NCT01700140|144584300|SUPERIORITY_OR_OTHER|||||||0.6761|TWO_SIDED||||||Fisher Exact|||Statistical analysis for complete response rate after the second irradiation||||0.6761
72527011|NCT01700140|144584300|SUPERIORITY_OR_OTHER|||||||0.3513|TWO_SIDED||||||Fisher Exact|||Statistical analysis for complete response rate after the second irradiation||||0.3513
72527012|NCT01700140|144584300|SUPERIORITY_OR_OTHER|||||||0.206|TWO_SIDED||||||Fisher Exact|||Statistical analysis for complete response rate after the third irradiation||||0.2060
72527013|NCT01700140|144584300|SUPERIORITY_OR_OTHER|||||||0.0511|TWO_SIDED||||||Fisher Exact|||Statistical analysis for complete response rate after the third irradiation||||0.0511
72527014|NCT02573012|144584304|SUPERIORITY||Least Square Means|0.613||||0.001|TWO_SIDED|95.0|0.346|0.879|||ANCOVA|||||0.879|0.346|0.001
72527015|NCT02573012|144584305|SUPERIORITY||Odds Ratio (OR)|0.5||||0.018|TWO_SIDED|95.0|0.285|0.889|||Regression, Logistic|||||0.889|0.285|0.018
72527016|NCT02573012|144584305|SUPERIORITY||Relative Risk|0.833||||0.021|TWO_SIDED|95.0|0.714|0.972|||Cochran-Mantel-Haenszel|||||0.972|0.714|0.021
72527017|NCT02573012|144584306|SUPERIORITY||Least Square Mean|2.342||||0.006|TWO_SIDED|95.0|0.661|4.023|||ANCOVA|||||4.023|0.661|0.006
72527018|NCT02573012|144584326|SUPERIORITY||Least Square Means|2.264||||0.009||95.0|0.574|3.953|||ANCOVA|||||3.953|0.574|0.009
72527019|NCT01610414|144584327|SUPERIORITY|Criterion: The lower limit (LL) of the 95% confidence interval (CI) for overall HZ vaccine efficacy was above 0%.|Vaccine efficacy|68.17|||<|0.0001|TWO_SIDED|95.0|55.56|77.53|||Poisson method|||Vaccine efficacy (VE) was evaluated in the prevention of Herpes Zoster (HZ) in autologous haematopoietic stem cell transplant (HCT) recipients 18 years of agee and older.||77.53|55.56|<0.0001
72527020|NCT02483611|144584354|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|149.0|STANDARD_DEVIATION|46.07||0.9651|TWO_SIDED|95.0|88.0|235.0|||ANOVA|||||235|88|0.9651
72527021|NCT02483611|144584354|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|145.3|STANDARD_DEVIATION|42.48||0.9651|TWO_SIDED|95.0|78.0|244.0|||ANOVA|||||244|78|0.9651
72527022|NCT02483611|144584354|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|147.8|STANDARD_DEVIATION|29.75||0.9651|TWO_SIDED|95.0|105.0|200.0|||ANOVA|||The sample size was calculated with a power of 80% to detect differences of 20% in the timing of clinical onset and the duration of NMB. The pharmacodynamic (latency, clinical duration, recovery rate and total duration) and hemodynamic variables (mean arterial pressure (MAP) and HR) were compared between the groups via analysis of variance (ANOVA) followed by the Tukey post-hoc test. The significance level was set at 5%.||200|105|0.9651
72527023|NCT02483611|144584355|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|82.68|||<|0.0001|TWO_SIDED|95.0|72.62|99.27|||Kruskal-Wallis|||||99.27|72.62|<0.0001
72527024|NCT02483611|144584355|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|86.33|||<|0.0001|TWO_SIDED|95.0|71.78|140.6|||Kruskal-Wallis|||||140.60|71.78|<0.0001
72407255|NCT00835497|144323011|NON_INFERIORITY_OR_EQUIVALENCE|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Test/Ref Ratio of LS Means x 100|93.0||||||90.0|88.8|97.5|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||97.5|88.8|
72527025|NCT02483611|144584355|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|64.8|||<|0.0001|TWO_SIDED|95.0|40.5|92.9|||Kruskal-Wallis|||||92.90|40.50|<0.0001
72527026|NCT02483611|144584356|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|20.08|STANDARD_DEVIATION|6.49||0.0015|TWO_SIDED|95.0|12.0|32.25|||ANOVA|||||32.25|12.00|0.0015
72527027|NCT02483611|144584356|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|20.26|STANDARD_DEVIATION|7.69||0.0015|TWO_SIDED|95.0|10.5|39.83|||ANOVA|||||39.83|10.50|0.0015
72527028|NCT02483611|144584356|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.53|STANDARD_DEVIATION|1.52||0.0015|TWO_SIDED|95.0|11.0|16.5|||ANOVA|||||16.50|11.00|0.0015
72527029|NCT02483611|144584357|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|27.97|STANDARD_DEVIATION|6.77||0.0003|TWO_SIDED|95.0|19.5|41.5|||ANOVA|||||41.50|19.50|0.0003
72527030|NCT02483611|144584357|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|33.81|STANDARD_DEVIATION|10.97||0.0003|TWO_SIDED|95.0|18.5|49.5|||ANOVA|||||49.50|18.50|0.0003
72527031|NCT02483611|144584357|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|21.51|STANDARD_DEVIATION|3.28||0.0003|TWO_SIDED|95.0|17.5|30.05|||ANOVA|||||30.05|17.50|0.0003
72527032|NCT02483611|144584358|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|113.2|STANDARD_DEVIATION|12.16|<|0.0001|TWO_SIDED|95.0|94.87|136.8|||ANOVA|||||136.80|94.87|<0.0001
72527033|NCT02483611|144584358|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|120.1|STANDARD_DEVIATION|18.2|<|0.0001|TWO_SIDED|95.0|95.82|163.3|||ANOVA|||||163.30|95.82|<0.0001
72527034|NCT02483611|144584358|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|88.19|STANDARD_DEVIATION|16.34|<|0.0001|TWO_SIDED|95.0|58.0|125.2|||ANOVA|||||125.20|58|<0.0001
72527035|NCT02483611|144584359|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|120.2|STANDARD_DEVIATION|10.88|<|0.0001|TWO_SIDED|95.0|106.3|140.2|||ANOVA|||||140.20|106.30|<0.0001
72527036|NCT02483611|144584359|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|126.7|STANDARD_DEVIATION|14.19|<|0.0001|TWO_SIDED|95.0|106.5|149.4|||ANOVA|||||149.40|106.50|<0.0001
72527037|NCT02483611|144584359|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|90.03|STANDARD_DEVIATION|12.78|<|0.0001|TWO_SIDED|95.0|71.75|116.4|||ANOVA|||||116.40|71.75|<0.0001
72527038|NCT02483611|144584360|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|94.63|STANDARD_DEVIATION|10.18||0.0527|TWO_SIDED|95.0|70.0|112.0|||ANOVA|||||112.00|70.00|0.0527
72527039|NCT02483611|144584360|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|88.75|STANDARD_DEVIATION|10.05||0.0527|TWO_SIDED|95.0|65.0|104.0|||ANOVA|||||104.00|65.00|0.0527
72527040|NCT02483611|144584360|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|100.1|STANDARD_DEVIATION|16.62||0.0527|TWO_SIDED|95.0|70.0|140.0|||ANOVA|||||140.00|70.00|0.0527
72527041|NCT02483611|144584361|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|87.63|STANDARD_DEVIATION|12.1||0.1996|TWO_SIDED|95.0|60.0|110.0|||ANOVA|||||110.00|60.00|0.1996
72527042|NCT02483611|144584361|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|84.69|STANDARD_DEVIATION|11.38||0.1996|TWO_SIDED|95.0|67.0|109.0|||ANOVA|||||109.00|67.00|0.1996
72527043|NCT02483611|144584361|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|92.47|STANDARD_DEVIATION|12.3||0.1996|TWO_SIDED|95.0|73.0|112.0|||ANOVA|||||112.00|73.00|0.1996
72527044|NCT02483611|144584362|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|75.88|STANDARD_DEVIATION|11.95||0.7145|TWO_SIDED|95.0|58.0|107.0|||ANOVA|||||107.00|58.00|0.7145
72527045|NCT02483611|144584362|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|73.88|STANDARD_DEVIATION|9.8||0.7145|TWO_SIDED|95.0|59.0|97.0|||ANOVA|||||97.00|59.00|0.7145
72527046|NCT02483611|144584362|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|76.73|STANDARD_DEVIATION|7.48||0.7145|TWO_SIDED|95.0|58.0|86.0|||ANOVA|||||86.00|58.00|0.7145
72527047|NCT02483611|144584363|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|69.0||||0.113|TWO_SIDED|95.0|57.0|96.0|||Kruskal-Wallis|||||96.00|57.00|0.1130
72527048|NCT02483611|144584363|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|63.0||||0.113|TWO_SIDED|95.0|55.0|84.0|||Kruskal-Wallis|||||84.00|55.00|0.1130
72527049|NCT02483611|144584363|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|74.0||||0.113|TWO_SIDED|95.0|59.0|83.0|||Kruskal-Wallis|||||83.00|59.00|0.1130
72527050|NCT02483611|144584364|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|62.5||||0.0731|TWO_SIDED|95.0|58.0|98.0|||Kruskal-Wallis|||||98.00|58.00|0.0731
72527051|NCT02483611|144584364|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|61.5||||0.0731|TWO_SIDED|95.0|55.0|74.0|||Kruskal-Wallis|||||74.00|55.00|0.0731
72527052|NCT02483611|144584364|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|67.0||||0.0731|TWO_SIDED|95.0|56.0|85.0|||Kruskal-Wallis|||||85.00|56.00|0.0731
72527053|NCT02483611|144584365|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|64.5||||0.1002|TWO_SIDED|95.0|60.0|85.0|||Kruskal-Wallis|||||85.00|60.00|0.1002
72527054|NCT02483611|144584365|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|64.0||||0.1002|TWO_SIDED|95.0|56.0|74.0|||Kruskal-Wallis|||||74.00|56.00|0.1002
72527055|NCT02483611|144584365|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|69.0||||0.1002|TWO_SIDED|95.0|60.0|90.0|||Kruskal-Wallis|||||90.00|60.00|0.1002
72527056|NCT02483611|144584366|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|79.94|STANDARD_DEVIATION|15.79||0.4338|TWO_SIDED|95.0|52.0|109.0|||ANOVA|||||109.00|52.00|0.4338
72527057|NCT02483611|144584366|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|77.25|STANDARD_DEVIATION|12.13||0.4338|TWO_SIDED|95.0|55.0|95.0|||ANOVA|||||95.00|55.00|0.4338
72527058|NCT02483611|144584366|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|73.67|STANDARD_DEVIATION|11.82||0.4338|TWO_SIDED|95.0|55.0|92.0|||ANOVA|||||92.00|55.00|0.4338
72527059|NCT02483611|144584367|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|74.69|STANDARD_DEVIATION|11.76||0.9167|TWO_SIDED|95.0|57.0|99.0|||ANOVA|||||99.00|57.00|0.9167
72527060|NCT02483611|144584367|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|73.69|STANDARD_DEVIATION|11.18||0.9167|TWO_SIDED|95.0|51.0|96.0|||ANOVA|||||96.00|51.00|0.9167
72527061|NCT02483611|144584367|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|75.4|STANDARD_DEVIATION|11.54||0.9167|TWO_SIDED|95.0|53.0|90.0|||ANOVA|||||90.00|53.00|0.9167
72527062|NCT02483611|144584368|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|72.94|STANDARD_DEVIATION|10.96||0.8067|TWO_SIDED|95.0|58.0|92.0|||ANOVA|||||92.00|58.00|0.8067
72527063|NCT02483611|144584368|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|74.19|STANDARD_DEVIATION|8.65||0.8067|TWO_SIDED|95.0|57.0|86.0|||ANOVA|||||86.00|57.00|0.8067
72527064|NCT02483611|144584368|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|75.4|STANDARD_DEVIATION|11.54||0.8067|TWO_SIDED|95.0|53.0|90.0|||ANOVA|||||90.00|53.00|0.8067
72527065|NCT02483611|144584369|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|71.94|STANDARD_DEVIATION|10.87||0.1015|TWO_SIDED|95.0|57.0|93.0|||ANOVA|||||93.00|57.00|0.1015
72527066|NCT02483611|144584369|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|72.25|STANDARD_DEVIATION|9.78||0.1015|TWO_SIDED|95.0|52.0|89.0|||ANOVA|||||89.00|52.00|0.1015
72527067|NCT02483611|144584369|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|65.07|STANDARD_DEVIATION|10.01||0.1015|TWO_SIDED|95.0|44.0|81.0|||ANOVA|||||81.00|44.00|0.1015
72527068|NCT02483611|144584370|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|67.56|STANDARD_DEVIATION|10.05||0.3423|TWO_SIDED|95.0|56.0|92.0|||ANOVA|||||92.00|56.00|0.3423
72527069|NCT02483611|144584370|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|69.31|STANDARD_DEVIATION|7.73||0.3423|TWO_SIDED|95.0|57.0|83.0|||ANOVA|||||83.00|57.00|0.3423
72527070|NCT02483611|144584370|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|64.27|STANDARD_DEVIATION|10.81||0.3423|TWO_SIDED|95.0|41.0|81.0|||ANOVA|||||81.00|41.00|0.3423
72527071|NCT02483611|144584371|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|66.5|STANDARD_DEVIATION|10.11||0.6817|TWO_SIDED|95.0|53.0|92.0|||ANOVA|||||92.00|53.00|0.6817
72527072|NCT02483611|144584371|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|68.19|STANDARD_DEVIATION|8.4||0.6817|TWO_SIDED|95.0|54.0|82.0|||ANOVA|||||82.00|54.00|0.6817
72527073|NCT02483611|144584371|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|65.13|STANDARD_DEVIATION|10.5||0.6817|TWO_SIDED|95.0|47.0|81.0|||ANOVA|||||81.00|47.00|0.6817
72527074|NCT02483611|144584372|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|66.0||||0.0937|TWO_SIDED|95.0|58.0|80.0|||Kruskal-Wallis|||||80.00|58.00|0.0937
72527075|NCT02483611|144584372|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|61.5||||0.0937|TWO_SIDED|95.0|56.0|90.0|||Kruskal-Wallis|||||90.00|56.00|0.0937
72527076|NCT02483611|144584372|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|69.0||||0.0937|TWO_SIDED|95.0|58.0|87.0|||Kruskal-Wallis|||||87.00|58.00|0.0937
72527077|NCT02483611|144584373|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|66.5||||0.1406|TWO_SIDED|95.0|60.0|88.0|||Kruskal-Wallis|||||88.00|60.00|0.1406
72527078|NCT02483611|144584373|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|63.5||||0.1406|TWO_SIDED|95.0|55.0|86.0|||Kruskal-Wallis|||||86.00|55.00|0.1406
72527079|NCT02483611|144584373|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|68.0||||0.1406|TWO_SIDED|95.0|55.0|84.0|||Kruskal-Wallis|||||84.00|55.00|0.1406
72527080|NCT02483611|144584374|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|69.25|STANDARD_DEVIATION|6.74||0.0504|TWO_SIDED|95.0|60.0|81.0|||ANOVA|||||81.00|60.00|0.0504
72527081|NCT02483611|144584374|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|63.0|STANDARD_DEVIATION|7.62||0.0504|TWO_SIDED|95.0|49.0|79.0|||ANOVA|||||79.00|49.00|0.0504
72527082|NCT02483611|144584374|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|69.0|STANDARD_DEVIATION|7.56||0.0504|TWO_SIDED|95.0|58.0|84.0|||ANOVA|||||84.00|58.00|0.0504
72527083|NCT02483611|144584375|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|68.0||||0.0205|TWO_SIDED|95.0|60.0|93.0|||Kruskal-Wallis|||||93.00|60.00|0.0205
72527084|NCT02483611|144584375|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|62.0||||0.0205|TWO_SIDED|95.0|54.0|72.0|||Kruskal-Wallis|||||72.00|54.00|0.0205
72527085|NCT02483611|144584375|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|66.0||||0.0205|TWO_SIDED|95.0|59.0|75.0|||Kruskal-Wallis|||||75.00|59.00|0.0205
72527086|NCT02483611|144584376|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|68.0||||0.3004|TWO_SIDED|95.0|58.0|86.0|||Kruskal-Wallis|||||86.00|58.00|0.3004
72527087|NCT02483611|144584376|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|66.0||||0.3004|TWO_SIDED|95.0|56.0|78.0|||Kruskal-Wallis|||||78.00|56.00|0.3004
72527088|NCT02483611|144584376|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|69.0||||0.3004|TWO_SIDED|95.0|62.0|81.0|||Kruskal-Wallis|||||81.00|62.00|0.3004
72527089|NCT02483611|144584377|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|64.0||||0.0178|TWO_SIDED|95.0|60.0|84.0|||Kruskal-Wallis|||||84.00|60.00|0.0178
72527090|NCT02483611|144584377|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|64.5||||0.0178|TWO_SIDED|95.0|51.0|75.0|||Kruskal-Wallis|||||75.00|51.00|0.0178
72527091|NCT02483611|144584377|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|72.0||||0.0178|TWO_SIDED|95.0|61.0|91.0|||Kruskal-Wallis|||||91.00|61.00|0.0178
72527092|NCT02483611|144584378|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|68.67|STANDARD_DEVIATION|8.51||0.8746|TWO_SIDED|95.0|51.0|99.0|||ANOVA|||||99.00|51.00|0.8746
72527093|NCT02483611|144584378|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|64.38|STANDARD_DEVIATION|6.96||0.8746|TWO_SIDED|95.0|56.0|82.0|||ANOVA|||||82.00|56.00|0.8746
72527094|NCT02483611|144584378|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|73.4|STANDARD_DEVIATION|7.94||0.8746|TWO_SIDED|95.0|54.0|80.0|||ANOVA|||||80.00|54.00|0.8746
72527095|NCT02483611|144584379|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|67.44|STANDARD_DEVIATION|10.95||0.4195|TWO_SIDED|95.0|47.0|92.0|||ANOVA|||||92.00|47.00|0.4195
72527096|NCT02483611|144584379|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|68.38|STANDARD_DEVIATION|9.28||0.4195|TWO_SIDED|95.0|53.0|80.0|||ANOVA|||||80.00|53.00|0.4195
72527097|NCT02483611|144584379|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|64.0|STANDARD_DEVIATION|8.23||0.4195|TWO_SIDED|95.0|52.0|80.0|||ANOVA|||||80.00|52.00|0.4195
72527098|NCT02483611|144584380|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|65.75|STANDARD_DEVIATION|11.52||0.5796|TWO_SIDED|95.0|47.0|93.0|||ANOVA|||||93.00|47.00|0.5796
72527099|NCT02483611|144584380|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|65.75|STANDARD_DEVIATION|10.19||0.5796|TWO_SIDED|95.0|48.0|79.0|||ANOVA|||||79.00|48.00|0.5796
72527100|NCT02483611|144584380|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|62.33|STANDARD_DEVIATION|9.26||0.5796|TWO_SIDED|95.0|50.0|79.0|||ANOVA|||||79.00|50.00|0.5796
72527101|NCT02483611|144584381|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|66.19|STANDARD_DEVIATION|12.82||0.5351|TWO_SIDED|95.0|45.0|92.0|||ANOVA|||||92.00|45.00|0.5351
72527102|NCT02483611|144584381|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|65.31|STANDARD_DEVIATION|10.87||0.5351|TWO_SIDED|95.0|47.0|82.0|||ANOVA|||||82.00|47.00|0.5351
72527103|NCT02483611|144584381|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|61.93|STANDARD_DEVIATION|9.0||0.5351|TWO_SIDED|95.0|51.0|79.0|||ANOVA|||||79.00|51.00|0.5351
72527104|NCT02483611|144584382|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|66.5||||0.4988|TWO_SIDED|95.0|42.0|92.0|||Kruskal-Wallis|||||92.00|42.00|0.4988
72527105|NCT02483611|144584382|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|63.0||||0.4988|TWO_SIDED|95.0|50.0|85.0|||Kruskal-Wallis|||||85.00|50.00|0.4988
72527106|NCT02483611|144584382|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|58.0||||0.4988|TWO_SIDED|95.0|51.0|80.0|||Kruskal-Wallis|||||80.00|51.00|0.4988
72527107|NCT02483611|144584383|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|66.0||||0.7723|TWO_SIDED|95.0|43.0|89.0|||Kruskal-Wallis|||||89.00|43.00|0.7723
72527108|NCT02483611|144584383|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|61.0||||0.7723|TWO_SIDED|95.0|51.0|82.0|||Kruskal-Wallis|||||82.00|51.00|0.7723
72527109|NCT02483611|144584383|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|61.0||||0.7723|TWO_SIDED|95.0|50.0|78.0|||Kruskal-Wallis|||||78.00|50.00|0.7723
72527110|NCT00286156|144584471|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED|||||Pairwise comparisons adjusted for multiple testing (Tukey)|ANOVA|||Null hypothesis: no difference between groups in iGFR||||<0.01
72527111|NCT05325333|144584477|SUPERIORITY|Word form recall accuracy (number of words correctly recalled) on Expanding and Standard retrieval schedules at 5 mins for children with DLD||||||0.567|||||||LSD test|||||||0.567
72527112|NCT05325333|144584477|SUPERIORITY|Word form recall accuracy (number of words correctly recalled) on Expanding and Standard retrieval schedules at 5 mins for children with TD||||||0.003|||||||LSD test|||||||0.003
72527113|NCT05325333|144584478|SUPERIORITY|Word form recall accuracy (number of words correctly recalled) on Expanding and Standard retrieval schedules at one week for children with DLD||||||0.187|||||||LSD test|||||||0.187
72527114|NCT05325333|144584478|SUPERIORITY|Word form recall accuracy (number of words correctly recalled) on Expanding and Standard retrieval schedules at one week for children with TD||||||0.256|||||||LSD test|||||||0.256
72527115|NCT05325333|144584479|SUPERIORITY|Word meaning recall accuracy (number of semantic associations correctly recalled) on Expanding and Standard Retrieval Schedules at 5 Mins for DLD||||||0.747|||||||LSD test|||||||0.747
72527116|NCT05325333|144584479|SUPERIORITY|Word meaning recall accuracy (number of semantic associations correctly recalled) on Expanding and Standard Retrieval Schedules at 5 Mins for TD||||||0.031|||||||LSD test|||||||0.031
72527117|NCT05325333|144584480|SUPERIORITY|Word meaning recall accuracy (number of semantic associations correctly recalled) on Expanding and Standard Retrieval Schedules at one week for DLD||||||0.061|||||||LSD test|||||||0.061
72527118|NCT05325333|144584480|SUPERIORITY|Word meaning recall accuracy (number of semantic associations correctly recalled) on Expanding and Standard Retrieval Schedules at one week for TD||||||0.747|||||||LSD test|||||||0.747
72527119|NCT05325333|144584481|SUPERIORITY|Word recognition (number of words accurately identified) on Expanding condition and Standard Retrieval Schedules for DLD||||||0.026|||||||LSD test|||||||0.026
72527120|NCT05325333|144584481|SUPERIORITY|Word recognition (number of words accurately identified) on Expanding condition and Standard Retrieval Schedules for TD||||||0.72|||||||LSD test|||||||0.720
72527121|NCT05325333|144584482|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||||||<.0001
72527122|NCT05325333|144584483|SUPERIORITY|||||||0.673|||||||t-test, 2 sided|||||||0.673
72527123|NCT00474539|144584571|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for immune response induced by NeisVac-C was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) greater than (\>) -10%.|Difference|-0.5||||||95.0|-3.3|2.0||||||For Meningococcal C the difference in percentages between the two groups (13vPnC - 7vPnC) at \>=1:8 titer was calculated||2.0|-3.3|
72527124|NCT00474539|144584574|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for or immune response induced by NeisVac-C was declared if the lower bound of the 2-sided, 95% CI for the GMT ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|0.86||||||95.0|0.69|1.08||||||For Meningococcal C the GMT ratio (13vPnC/7vPnC) was calculated||1.08|0.69|
72527125|NCT00474539|144584574|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for or immune response induced by NeisVac-C was declared if the lower bound of the 2-sided, 95% CI for the GMT ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|1.23||||||95.0|0.97|1.55||||||For Meningococcal C the GMT ratio (13vPnC/7vPnC) was calculated||1.55|0.97|
72527126|NCT00474539|144584575|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|-0.6||||||95.0|-3.5|2.0||||||For diphtheria the difference in percentage between the two groups (13vPnC - 7vPnC) at \>=0.10 IU/mL threshold was calculated||2.0|-3.5|
72527127|NCT00474539|144584575|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|0.0||||||95.0|-1.9|1.7||||||For diphtheria the difference in percentage between the two groups (13vPnC - 7vPnC) at \>=0.01 IU/mL threshold was calculated||1.7|-1.9|
72527128|NCT00474539|144584575|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|-0.2||||||95.0|-4.4|4.0||||||For tetanus the difference in percentage between the two groups (13vPnC - 7vPnC) at \>=0.10 IU/mL threshold was calculated||4.0|-4.4|
72527129|NCT00474539|144584575|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|0.0||||||95.0|-2.1|2.0||||||For tetanus the difference in percentage between the two groups (13vPnC - 7vPnC) at \>=0.01 IU/mL threshold was calculated||2.0|-2.1|
72527130|NCT00474539|144584575|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Ratio|0.0||||||95.0|-2.2|2.2||||||For diphtheria the difference in percentage between the two groups (13vPnC - 7vPnC) at \>=0.10 IU/mL threshold was calculated||2.2|-2.2|
72527131|NCT00474539|144584575|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Ratio|0.0||||||95.0|-2.2|2.2||||||For diphtheria the difference in percentage between the two groups (13vPnC - 7vPnC) at \>=0.01 IU/mL threshold was calculated||2.2|-2.2|
72527132|NCT00474539|144584575|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Ratio|0.0||||||95.0|-2.3|2.2||||||For tetanus the difference in percentage between the two groups (13vPnC - 7vPnC) at \>=0.10 IU/mL threshold was calculated||2.2|-2.3|
72527133|NCT00474539|144584575|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Ratio|0.0||||||95.0|-2.3|2.2||||||For tetanus the difference in percentage between the two groups (13vPnC - 7vPnC) at \>=0.01 IU/mL threshold was calculated||2.2|-2.3|
72527134|NCT00474539|144584576|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|0.86||||||95.0|0.72|1.03||||||For diphtheria toxoid the GMC ratio (13vPnC/7vPnC) was calculated||1.03|0.72|
72571450|NCT00117325|144671702|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.659||||0.018|TWO_SIDED|95.0|-1.2|-0.11|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM iTNSS at Day 28||-0.11|-1.20|0.018
72571451|NCT00117325|144671702|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.222||||0.194|TWO_SIDED|95.0|-0.56|0.1|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for rTNSS at Day 1||0.1|-0.56|0.194
72527135|NCT00474539|144584576|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|0.91||||||95.0|0.74|1.12||||||For tetanus the GMC ratio (13vPnC/7vPnC) was calculated||1.12|0.74|
72527136|NCT00474539|144584576|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|0.93||||||95.0|0.78|1.1||||||For diphtheria toxoid the GMC ratio (13vPnC/7vPnC) was calculated||1.10|0.78|
72527137|NCT00474539|144584576|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|1.0||||||95.0|0.81|1.24||||||For tetanus the GMC ratio (13vPnC/7vPnC) was calculated||1.24|0.81|
72527138|NCT00474539|144584579|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for immune response induced by NeisVac-C was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|0.6||||||95.0|-1.7|3.2||||||For Meningococcal C the difference in percentages between the two groups (13vPnC - 7vPnC) at ≥ 1:8 titer was calculated.||3.2|-1.7|
72527139|NCT02061540|144584581|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-14.841|STANDARD_ERROR_OF_MEAN|6.0373||0.0043|TWO_SIDED|95.0|-27.251|-2.432|||Wilcoxon's signed rank test|||Analysis was performed to compare baseline and endpoint data.||-2.432|-27.251|0.0043
72527140|NCT03442595|144584622|OTHER|test of difference in change of A1C between the two groups|||||<|0.001|||||||t-test, 2 sided|||The study was powered to detect a difference of 0.5% in the change in A1C with SD = 2 with 80\& at alopha = 0.;05 with a sample size of 128 in each group (paired t-test). The study reaches 100% power to detect this observed difference with an alpha level of 0.01.||||<0.001
72527141|NCT04107935|144584684|SUPERIORITY|||||||0.983||||||Propensity score matching was used to form pairs of intervention and control participants. Specifically, a greedy matching procedure with a matching caliper of 0.2 of the standard deviation of the logit of the propensity score was used.|Mixed Models Analysis|Since baseline characteristics achieved a good balance, those variables were not entered into the propensity score matched model.||||||0.9830
72527142|NCT04107935|144584685|SUPERIORITY|||||||0.8365||||||Adjusted for age, race, body mass index, and time|Mixed Models Analysis|||||||0.8365
72571452|NCT00117325|144671702|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.263||||0.134|TWO_SIDED|95.0|-0.61|0.08|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for rTNSS at Day 2||0.08|-0.61|0.134
72527143|NCT04107935|144584686|SUPERIORITY|||||||0.5727||||||Adjusted for age, race, body mass index, and time|Mixed Models Analysis|||||||0.5727
72527144|NCT04107935|144584687|SUPERIORITY|||||||0.9381||||||Adjusted for age, race, body mass index, and time|Mixed Models Analysis|||||||0.9381
72527145|NCT04107935|144584689|SUPERIORITY|||||||0.608||||||Adjusted for age, race, body mass index, and time|Mixed Models Analysis|||||||0.608
72527146|NCT01021553|144584690|SUPERIORITY_OR_OTHER||Geometric LS Mean Fold Difference|1.16||||0.4959|TWO_SIDED|95.0|0.75|1.79|||ANCOVA||Estimated value is Geometric LS Mean Fold Difference from Placebo.|||1.79|0.75|0.4959
72527147|NCT01021553|144584690|SUPERIORITY_OR_OTHER||Geometric LS Mean Fold Difference|1.11||||0.6161|TWO_SIDED|95.0|0.74|1.65|||ANCOVA||Estimated value is Geometric LS Mean Fold Difference from Placebo.|||1.65|0.74|0.6161
72527148|NCT01021553|144584690|SUPERIORITY_OR_OTHER||Geometric LS Mean Fold Difference|1.13||||0.4971|TWO_SIDED|95.0|0.79|1.61|||ANCOVA||Estimated value is Geometric LS Mean Fold Difference from Placebo.|||1.61|0.79|0.4971
72527149|NCT01021553|144584691|SUPERIORITY_OR_OTHER||Geometric LS Mean Fold Difference|1.03||||0.9037|TWO_SIDED|95.0|0.67|1.58|||ANCOVA||Estimated value is Geometric LS Mean Fold Difference from Placebo.|For Week 0 to 4||1.58|0.67|0.9037
72527150|NCT01021553|144584691|SUPERIORITY_OR_OTHER||Geometric LS Mean Fold Difference|1.0||||0.9939|TWO_SIDED|95.0|0.67|1.48|||ANCOVA||Estimated value is Geometric LS Mean Fold Difference from Placebo.|For Week 0 to 4||1.48|0.67|0.9939
72527151|NCT01021553|144584691|SUPERIORITY_OR_OTHER||Geometric LS Mean Fold Difference|1.01||||0.9541|TWO_SIDED|95.0|0.71|1.43|||ANCOVA||Estimated value is Geometric LS Mean Fold Difference from Placebo.|For Weeks 0-4||1.43|0.71|0.9541
72407256|NCT02346240|144323012|SUPERIORITY||Estimated difference in responder rate|61.6|||||TWO_SIDED|95.0|52.1|71.2|||Regression, Logistic|Estimated responder rate, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.|Estimate and 95 % CI for difference in proportion of responders for CZP 400 mg Q2W (RS) versus Placebo Q2W (RS).|The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||71.2|52.1|
72527152|NCT01021553|144584691|SUPERIORITY_OR_OTHER||Geometric LS Mean Fold Difference|1.33||||0.2798|TWO_SIDED|95.0|0.79|2.24|||ANCOVA||Estimated value is Geometric LS Mean Fold Difference from Placebo.|For Weeks 4-8||2.24|0.79|0.2798
72527153|NCT01021553|144584691|SUPERIORITY_OR_OTHER||Geometric LS Mean Fold Difference|1.09||||0.7255|TWO_SIDED|95.0|0.68|1.75|||ANCOVA||Estimated value is Geometric LS Mean Fold Difference from Placebo.|For Weeks 4-8||1.75|0.68|0.7255
72527154|NCT01021553|144584691|SUPERIORITY_OR_OTHER||Geometric LS Mean Fold Difference|1.18||||0.4347|TWO_SIDED|95.0|0.77|1.8|||ANCOVA||Estimated value is Geometric LS Mean Fold Difference from Placebo.|For Weeks 4-8||1.80|0.77|0.4347
72527155|NCT01021553|144584692|SUPERIORITY_OR_OTHER||Geometric LS Mean Fold Difference|1.14||||0.6583|TWO_SIDED|95.0|0.63|2.05|||ANCOVA||Estimated value is Geometric LS Mean Fold Difference from Placebo.|||2.05|0.63|0.6583
72527156|NCT01021553|144584692|SUPERIORITY_OR_OTHER||Geometric LS Mean Fold Difference|0.96||||0.879|TWO_SIDED|95.0|0.56|1.65|||ANCOVA||Estimated value is Geometric LS Mean Fold Difference from Placebo.|||1.65|0.56|0.8790
72527157|NCT01021553|144584692|SUPERIORITY_OR_OTHER||Geometric LS Mean Fold Difference|1.03||||0.8971|TWO_SIDED|95.0|0.64|1.67|||ANCOVA||Estimated value is Geometric LS Mean Fold Difference from Placebo.|||1.67|0.64|0.8971
72527158|NCT01021553|144584695|SUPERIORITY_OR_OTHER||Ratio of treatments|2.91|||||TWO_SIDED|90.0|2.43|3.48|||||For AUC (0-inf)|||3.48|2.43|
72527159|NCT01021553|144584695|SUPERIORITY_OR_OTHER||Ratio of treatments|2.98|||||TWO_SIDED|90.0|2.51|3.54||||||||3.54|2.51|
72527160|NCT01021553|144584696|SUPERIORITY_OR_OTHER||Ratio of treatments|3.63|||||TWO_SIDED|90.0|2.95|4.47||||||||4.47|2.95|
72571453|NCT00117325|144671702|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.31||||0.091|TWO_SIDED|95.0|-0.67|0.05|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for rTNSS at Day 3||0.05|-0.67|0.091
72527161|NCT00033293|144584705|OTHER||Chi-squared test statistic|8.125||||0.0044|TWO_SIDED|95.0||||No adjustments for multiple comparisons.|Chi-squared|A two-way test with a null hypothesis of no association, using SAS 9.4.||"The 5 categories of OMA ratings are: stance, gait, arm \& hand function, opsoclonus, \& mood/behavior. For each category, a patient's response will be based on a comparison of the baseline evaluation to the best of 3 time points: 2 months, 6 months \& 1 year. If a patient crosses over to the IVIG arm or switches to ACTH at any time, the patient will be considered a non-responder. The proportion of responders from the 2 treatment arms were compared using a chi-squared test."||||0.0044
72527162|NCT00033293|144584706|OTHER||Mean Difference (Net)|60.1979||||0.0919|ONE_SIDED||||||t-test, 1 sided|||The two samples from the respective treatment arms were compared using a one-sided t-test with a significance level of .05.||||0.0919
72527163|NCT00033293|144584707|OTHER|The two samples from the respective treatment arms were compared using a one-sided t-test with a significance level of .05.|Mean Difference (Net)|16.75||||0.2364|ONE_SIDED||||||t-test, 1 sided|||||||0.2364
72527164|NCT00935701|144584713|SUPERIORITY_OR_OTHER|||||||0.01|||||||Wilcoxon (Mann-Whitney)|||Mean change in score from pre to post on Restless-Impulsive subscale||||0.01
72527165|NCT00935701|144584713|SUPERIORITY_OR_OTHER|||||||0.09|||||||Wilcoxon (Mann-Whitney)|||Mean change in score from pre to post on Emotional Lability subscale||||0.09
72527166|NCT00935701|144584713|SUPERIORITY_OR_OTHER|||||||0.02|||||||Wilcoxon (Mann-Whitney)|||Mean change in score from pre to post on Global Index Total||||0.02
72527167|NCT00935701|144584713|SUPERIORITY_OR_OTHER|||||||0.01|||||||Wilcoxon (Mann-Whitney)|||Mean change in score from pre to post on DSM-IV Inattentive subscale||||0.01
72527168|NCT00935701|144584713|SUPERIORITY_OR_OTHER|||||||0.03|||||||Wilcoxon (Mann-Whitney)|||Mean change in score from pre to post on DSM-IV Hyperactive-Impulsive subscale||||0.03
72527169|NCT00935701|144584713|SUPERIORITY_OR_OTHER|||||||0.01|||||||Wilcoxon (Mann-Whitney)|||Mean change in score from pre to post on DSM-IV Total||||0.01
72527170|NCT00935701|144584714|SUPERIORITY_OR_OTHER|||||||0.08|||||||Wilcoxon (Mann-Whitney)|||Mean change in score from pre to post on Bedtime Resistance subscale||||0.08
72527171|NCT00935701|144584714|SUPERIORITY_OR_OTHER|||||||0.03|||||||Wilcoxon (Mann-Whitney)|||Mean change in score from pre to post on Sleep Onset Delay subscale||||0.03
72527172|NCT00935701|144584714|SUPERIORITY_OR_OTHER|||||||0.82|||||||Wilcoxon (Mann-Whitney)|||Mean change in score from pre to post on Sleep Duration subscale||||0.82
72527173|NCT00935701|144584714|SUPERIORITY_OR_OTHER|||||||0.58|||||||Wilcoxon (Mann-Whitney)|||Mean change in score from pre to post on Sleep Anxiety subscale||||0.58
72527174|NCT00935701|144584714|SUPERIORITY_OR_OTHER|||||||0.66|||||||Wilcoxon (Mann-Whitney)|||Mean change in score from pre to post on Night Wakings subscale||||0.66
72527175|NCT00935701|144584714|SUPERIORITY_OR_OTHER|||||||0.18|||||||Wilcoxon (Mann-Whitney)|||Mean change in score from pre to post on Parasomnias subscale||||0.18
72527176|NCT00935701|144584714|SUPERIORITY_OR_OTHER|||||||0.31|||||||Wilcoxon (Mann-Whitney)|||Mean change in score from pre to post on Daytime Sleepiness subscale||||0.31
72527177|NCT00935701|144584714|SUPERIORITY_OR_OTHER|||||||0.07|||||||Wilcoxon (Mann-Whitney)|||Mean change in score from pre to post on Total Disturbance||||0.07
72527178|NCT00935701|144584715|SUPERIORITY_OR_OTHER|||||||0.04|||||||Wilcoxon (Mann-Whitney)|||Mean change in score from pre to post on Child Domain Total||||0.04
72527179|NCT00935701|144584715|SUPERIORITY_OR_OTHER|||||||0.31|||||||Wilcoxon (Mann-Whitney)|||Mean change in score from pre to post on Parent Domain Total||||0.31
72527180|NCT00935701|144584715|SUPERIORITY_OR_OTHER|||||||0.07|||||||Wilcoxon (Mann-Whitney)|||Mean change in score from pre to post on Total Stress||||0.07
72527181|NCT04623255|144584716|SUPERIORITY|||||||0.16|||||||Chi-squared|||The primary analysis will involve a comparison of the binary outcome '50% reduction in at least two inflammation markers' between the PEX and Standard of Care (control) trial arms using a chi-squared test. The risk difference (and ratio) will be estimated with a 95% confidence interval.||||0.16
72527182|NCT04623255|144584717|SUPERIORITY|||||||0.606|TWO_SIDED|95.0|||||Chi-squared|||The primary analysis will involve a comparison of the binary outcome '50% reduction in inflammation marker CRP' between the PEX and Standard of Care (control) trial arms using a chi-squared test. The risk difference (and ratio) will be estimated with a 95% confidence interval.||||0.606
72571454|NCT00117325|144671702|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.278||||0.131|TWO_SIDED|95.0|-0.64|0.08|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for rTNSS at Day 4||0.08|-0.64|0.131
72527183|NCT04623255|144584718|SUPERIORITY|||||||0.245|||||||Chi-squared|||The primary analysis will involve a comparison of the binary outcome '50% reduction in inflammation marker D-Dimer' between the PEX and Standard of Care (control) trial arms using a chi-squared test. The risk difference (and ratio) will be estimated with a 95% confidence interval.||||0.245
72527184|NCT04623255|144584719|SUPERIORITY|||||||0.653|||||||Chi-squared|||The primary analysis will involve a comparison of the binary outcome '50% reduction in inflammation marker LDH' between the PEX and Standard of Care (control) trial arms using a chi-squared test. The risk difference (and ratio) will be estimated with a 95% confidence interval.||||0.653
72527185|NCT00998985|144584728|SUPERIORITY_OR_OTHER||Least Squares Mean (LSM) Difference|3.46|||||TWO_SIDED|90.0|2.89|4.03|||||LSM Difference (grazoprevir-placebo) and confidence intervals from ANOVA model with maximum log10 HCV reduction as response and a fixed effect for treatment.|It is hypothesized that one or more doses of Grazoprevir will reduce GT1 viral load by at least 3 log10||4.03|2.89|
72527186|NCT00998985|144584728|SUPERIORITY_OR_OTHER||LSM Difference|4.68|||||TWO_SIDED|90.0|4.11|5.25|||||LSM Difference (grazoprevir-placebo) and confidence intervals from ANOVA model with maximum log10 HCV reduction as response and a fixed effect for treatment.|It is hypothesized that one or more doses of Grazoprevir will reduce GT1 viral load by at least 3 log10||5.25|4.11|
72527187|NCT00998985|144584728|SUPERIORITY_OR_OTHER||LSM Difference|4.87|||||TWO_SIDED|90.0|4.3|5.44|||||LSM Difference (grazoprevir-placebo) and confidence intervals from ANOVA model with maximum log10 HCV reduction as response and a fixed effect for treatment.|It is hypothesized that one or more doses of Grazoprevir will reduce GT1 viral load by at least 3 log10||5.44|4.30|
72527188|NCT00998985|144584728|SUPERIORITY_OR_OTHER||LSM Difference|4.35|||||TWO_SIDED|90.0|3.78|4.92|||||LSM Difference (grazoprevir-placebo) and confidence intervals from ANOVA model with maximum log10 HCV reduction as response and a fixed effect for treatment.|It is hypothesized that one or more doses of Grazoprevir will reduce GT1 viral load by at least 3 log10||4.92|3.78|
72527189|NCT00998985|144584728|SUPERIORITY_OR_OTHER||LSM Difference|5.15|||||TWO_SIDED|90.0|4.58|5.72|||||LSM Difference (grazoprevir-placebo) and confidence intervals from ANOVA model with maximum log10 HCV reduction as response and a fixed effect for treatment.|It is hypothesized that one or more doses of Grazoprevir will reduce GT1 viral load by at least 3 log10||5.72|4.58|
72527190|NCT00998985|144584728|SUPERIORITY_OR_OTHER||LSM Difference|4.76|||||TWO_SIDED|90.0|4.19|5.33|||||LSM Difference (grazoprevir-placebo) and confidence intervals from ANOVA model with maximum log10 HCV reduction as response and a fixed effect for treatment.|It is hypothesized that one or more doses of Grazoprevir will reduce GT1 viral load by at least 3 log10||5.33|4.19|
72571455|NCT00117325|144671702|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.13||||0.483|TWO_SIDED|95.0|-0.49|0.23|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for rTNSS at Day 5||0.23|-0.49|0.483
72527191|NCT00998985|144584728|SUPERIORITY_OR_OTHER||LSM Difference|4.93|||||TWO_SIDED|90.0|4.36|5.5|||||LSM Difference (grazoprevir-placebo) and confidence intervals from ANOVA model with maximum log10 HCV reduction as response and a fixed effect for treatment.|It is hypothesized that one or more doses of Grazoprevir will reduce GT1 viral load by at least 3 log10||5.50|4.36|
72527192|NCT00998985|144584728|SUPERIORITY_OR_OTHER||LSM Difference|5.34|||||TWO_SIDED|90.0|4.93|5.74|||||LSM Difference (grazoprevir-placebo) and confidence intervals from ANOVA model with maximum log10 HCV reduction as response and a fixed effect for treatment.|It is hypothesized that one or more doses of Grazoprevir will reduce GT1 viral load by at least 3 log10||5.74|4.93|
72527193|NCT00998985|144584729|SUPERIORITY_OR_OTHER||LSM Difference|2.25|||||TWO_SIDED|90.0|1.7|2.81|||||LSM Difference (grazoprevir-placebo) and confidence intervals from ANOVA model with maximum log10 HCV reduction as response and a fixed effect for treatment.|It is hypothesized that one or more doses of Grazoprevir will reduce GT3 viral load by at least 2 log10||2.81|1.70|
72527194|NCT00998985|144584729|SUPERIORITY_OR_OTHER||LSM Difference|2.94|||||TWO_SIDED|90.0|2.38|3.49|||||LSM Difference (grazoprevir-placebo) and confidence intervals from ANOVA model with maximum log10 HCV reduction as response and a fixed effect for treatment.|It is hypothesized that one or more doses of Grazoprevir will reduce GT3 viral load by at least 2 log10||3.49|2.38|
72527195|NCT00998985|144584729|SUPERIORITY_OR_OTHER||LSM Difference|3.84|||||TWO_SIDED|90.0|3.29|4.4|||||LSM Difference (grazoprevir-placebo) and confidence intervals from ANOVA model with maximum log10 HCV reduction as response and a fixed effect for treatment.|It is hypothesized that one or more doses of Grazoprevir will reduce GT3 viral load by at least 2 log10||4.40|3.29|
72527196|NCT00998985|144584729|SUPERIORITY_OR_OTHER||LSM difference|4.98|||||TWO_SIDED|90.0|4.42|5.53|||||LSM Difference (grazoprevir-placebo) and confidence intervals from ANOVA model with maximum log10 HCV reduction as response and a fixed effect for treatment.|It is hypothesized that one or more doses of Grazoprevir will reduce GT3 viral load by at least 2 log10||5.53|4.42|
72527197|NCT00998985|144584729|SUPERIORITY_OR_OTHER||LSM difference|4.21|||||TWO_SIDED|90.0|3.6|4.81|||||LSM Difference (grazoprevir-placebo) and confidence intervals from ANOVA model with maximum log10 HCV reduction as response and a fixed effect for treatment.|It is hypothesized that one or more doses of Grazoprevir will reduce GT3 viral load by at least 2 log10||4.81|3.60|
72527198|NCT01040728|144584736|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.197|STANDARD_ERROR_OF_MEAN|0.017|<|0.0001||95.0|0.163|0.231|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 5 mcg qd minus Placebo|||0.231|0.163|<0.0001
72527199|NCT01040728|144584736|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.221|STANDARD_ERROR_OF_MEAN|0.018|<|0.0001||95.0|0.186|0.255|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 10 mcg qd minus Placebo|||0.255|0.186|<0.0001
72527200|NCT01040728|144584736|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.221|STANDARD_ERROR_OF_MEAN|0.017|<|0.0001||95.0|0.187|0.255|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Tio 18 mcg qd minus Placebo|||0.255|0.187|<0.0001
72527201|NCT01040728|144584737|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.153|STANDARD_ERROR_OF_MEAN|0.018|<|0.0001||95.0|0.117|0.188|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 5 mcg qd minus Placebo|||0.188|0.117|<0.0001
72527202|NCT01040728|144584737|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.17|STANDARD_ERROR_OF_MEAN|0.018|<|0.0001||95.0|0.134|0.205|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 10 mcg qd minus Placebo|||0.205|0.134|<0.0001
72527203|NCT01040728|144584737|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.164|STANDARD_ERROR_OF_MEAN|0.018|<|0.0001||95.0|0.128|0.199|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Tio 18 mcg qd minus Placebo|||0.199|0.128|<0.0001
72527204|NCT01040728|144584738|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.175|STANDARD_ERROR_OF_MEAN|0.017|<|0.0001||95.0|0.141|0.208|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 5 mcg qd minus Placebo|||0.208|0.141|<0.0001
72527205|NCT01040728|144584738|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.191|STANDARD_ERROR_OF_MEAN|0.017|<|0.0001||95.0|0.157|0.225|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 10 mcg qd minus Placebo|||0.225|0.157|<0.0001
72527206|NCT01040728|144584738|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.192|STANDARD_ERROR_OF_MEAN|0.017|<|0.0001||95.0|0.159|0.226|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Tio 18 mcg qd minus Placebo|||0.226|0.159|<0.0001
72527207|NCT01040728|144584739|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.214|STANDARD_ERROR_OF_MEAN|0.017|<|0.0001||95.0|0.181|0.248|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 5 mcg qd minus Placebo|||0.248|0.181|<0.0001
72527208|NCT01040728|144584739|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.238|STANDARD_ERROR_OF_MEAN|0.017|<|0.0001||95.0|0.205|0.272|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 10 mcg qd minus Placebo|||0.272|0.205|<0.0001
72527209|NCT01040728|144584739|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.152|STANDARD_ERROR_OF_MEAN|0.017|<|0.0001||95.0|0.119|0.185|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Tio 18 mcg qd minus Placebo|||0.185|0.119|<0.0001
72571456|NCT00117325|144671702|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.301||||0.137|TWO_SIDED|95.0|-0.7|0.1|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for rTNSS at Day 6||0.10|-0.70|0.137
72571457|NCT00117325|144671702|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.297||||0.142|TWO_SIDED|95.0|-0.69|0.1|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for rTNSS at Day 7||0.10|-0.69|0.142
72571458|NCT00117325|144671702|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.245||||0.22|TWO_SIDED|95.0|-0.64|0.15|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for rTNSS at Day 8||0.15|-0.64|0.220
72571459|NCT00117325|144671702|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.373||||0.081|TWO_SIDED|95.0|-0.79|0.05|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for rTNSS at Day 9||0.05|-0.79|0.081
72571460|NCT00117325|144671702|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.453||||0.034|TWO_SIDED|95.0|-0.87|-0.04|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for rTNSS at Day 10||-0.04|-0.87|0.034
72571461|NCT00117325|144671702|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.314||||0.15|TWO_SIDED|95.0|-0.74|0.11|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for rTNSS at Day 11||0.11|-0.74|0.150
72571462|NCT00117325|144671702|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.333||||0.111|TWO_SIDED|95.0|-0.74|0.08|||ANCOVA|||Placebo versus Fluticasone Furoate 110 mcg QD for rTNSS at Day 12||0.08|-0.74|0.111
72527210|NCT01040728|144584740|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.214|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.178|0.251|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 5 mcg qd minus Placebo|||0.251|0.178|<0.0001
72527211|NCT01040728|144584740|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.245|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.208|0.282|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 10 mcg qd minus Placebo|||0.282|0.208|<0.0001
72527212|NCT01040728|144584740|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.235|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.199|0.271|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Tio 18 mcg qd minus Placebo|||0.271|0.199|<0.0001
72527213|NCT01040728|144584741|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.237|STANDARD_ERROR_OF_MEAN|0.018|<|0.0001||95.0|0.201|0.273|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 5 mcg qd minus Placebo|||0.273|0.201|<0.0001
72527214|NCT01040728|144584741|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.266|STANDARD_ERROR_OF_MEAN|0.018|<|0.0001||95.0|0.23|0.302|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 10 mcg qd minus Placebo|||0.302|0.230|<0.0001
72527215|NCT01040728|144584741|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.175|STANDARD_ERROR_OF_MEAN|0.018|<|0.0001||95.0|0.138|0.211|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Tio 18 mcg qd minus Placebo|||0.211|0.138|<0.0001
72527216|NCT01040728|144584742|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.208|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.169|0.246|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 5 mcg qd minus Placebo|||0.246|0.169|<0.0001
72571463|NCT00117325|144671702|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.25||||0.261|TWO_SIDED|95.0|-0.69|0.19|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for rTNSS at Day 13||0.19|-0.69|0.261
72527217|NCT01040728|144584742|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.243|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001||95.0|0.205|0.282|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 10 mcg qd minus Placebo|||0.282|0.205|<0.0001
72527218|NCT01040728|144584742|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.244|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.205|0.282|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Tio 18 mcg qd minus Placebo|||0.282|0.205|<0.0001
72527219|NCT01040728|144584743|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.134|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.097|0.171|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 5 mcg qd minus Placebo|||0.171|0.097|<0.0001
72527220|NCT01040728|144584743|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.143|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.105|0.181|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 10 mcg qd minus Placebo|||0.181|0.105|<0.0001
72527221|NCT01040728|144584743|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.158|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.12|0.195|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Tio 18 mcg qd minus Placebo|||0.195|0.120|<0.0001
72527222|NCT01040728|144584744|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.33|STANDARD_ERROR_OF_MEAN|0.028|<|0.0001||95.0|0.276|0.384|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 5 mcg qd minus Placebo|||0.384|0.276|<0.0001
72527223|NCT01040728|144584744|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.326|STANDARD_ERROR_OF_MEAN|0.028|<|0.0001||95.0|0.272|0.381|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 10 mcg qd minus Placebo|||0.381|0.272|<0.0001
72527224|NCT01040728|144584744|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.37|STANDARD_ERROR_OF_MEAN|0.027|<|0.0001||95.0|0.316|0.424|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Tio 18 mcg qd minus Placebo|||0.424|0.316|<0.0001
72527225|NCT01040728|144584745|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.278|STANDARD_ERROR_OF_MEAN|0.033|<|0.0001||95.0|0.214|0.342|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 5 mcg qd minus Placebo|||0.342|0.214|<0.0001
72571464|NCT00117325|144671702|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.342||||0.123|TWO_SIDED|95.0|-0.78|0.09|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for rTNSS at Day 14||0.09|-0.78|0.123
72571465|NCT00117325|144671702|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.415||||0.056|TWO_SIDED|95.0|-0.84|0.01|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for rTNSS at Day 15||0.01|-0.84|0.056
72527226|NCT01040728|144584745|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.264|STANDARD_ERROR_OF_MEAN|0.033|<|0.0001||95.0|0.2|0.329|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 10 mcg qd minus Placebo|||0.329|0.200|<0.0001
72407257|NCT02346240|144323012|SUPERIORITY||Estimated difference in responder rate|56.2|||||TWO_SIDED|95.0|46.4|66.0|||Regression, Logistic|Estimated responder rate, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.|Estimate and 95 % CI for difference in proportion of responders for CZP 200 mg Q2W (RS) versus Placebo Q2W (RS).|The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||66.0|46.4|
72407258|NCT02346240|144323012|SUPERIORITY||Odds Ratio (OR)|37.988|||<|0.0001|TWO_SIDED|95.0|11.312|127.576||The p-value is evaluated at a 2-sided significance level for CZP 400 mg vs. PBO.|Regression, Logistic|Odds ratios, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.||The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||127.576|11.312|<0.0001
72407259|NCT02346240|144323012|SUPERIORITY||Odds Ratio (OR)|30.023|||<|0.0001|TWO_SIDED|95.0|8.971|100.481||The p-value is evaluated at a 2-sided significance level for CZP 200 mg vs. PBO.|Regression, Logistic|Odds ratios, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.||The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||100.481|8.971|<0.0001
72407260|NCT02346240|144323012|SUPERIORITY||Estimated difference in responder rate|13.4|||||TWO_SIDED|95.0|2.7|24.1|||Regression, Logistic|Estimated responder rate, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure|Estimate and 95 % CI for difference in proportion of responders for CZP 400 mg Q2W (RS) versus Etanercept Q2W (RS).|The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||24.1|2.7|
72527227|NCT01040728|144584745|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.302|STANDARD_ERROR_OF_MEAN|0.033|<|0.0001||95.0|0.238|0.366|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Tio 18 mcg qd minus Placebo|||0.366|0.238|<0.0001
72527228|NCT01040728|144584746|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.304|STANDARD_ERROR_OF_MEAN|0.03|<|0.0001||95.0|0.244|0.363|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 5 mcg qd minus Placebo|||0.363|0.244|<0.0001
72527229|NCT01040728|144584746|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.283|STANDARD_ERROR_OF_MEAN|0.031|<|0.0001||95.0|0.222|0.343|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 10 mcg qd minus Placebo|||0.343|0.222|<0.0001
72527230|NCT01040728|144584746|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.335|STANDARD_ERROR_OF_MEAN|0.03|<|0.0001||95.0|0.275|0.395|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Tio 18 mcg qd minus Placebo|||0.395|0.275|<0.0001
72527231|NCT01040728|144584747|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.37|STANDARD_ERROR_OF_MEAN|0.031|<|0.0001||95.0|0.309|0.43|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 5 mcg qd minus Placebo|||0.430|0.309|<0.0001
72527232|NCT01040728|144584747|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.366|STANDARD_ERROR_OF_MEAN|0.03|<|0.0001||95.0|0.306|0.426|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 10 mcg qd minus Placebo|||0.426|0.306|<0.0001
72527233|NCT01040728|144584747|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.262|STANDARD_ERROR_OF_MEAN|0.03|<|0.0001||95.0|0.202|0.322|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Tio 18 mcg qd minus Placebo|||0.322|0.202|<0.0001
72527234|NCT01040728|144584748|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.344|STANDARD_ERROR_OF_MEAN|0.029|<|0.0001||95.0|0.287|0.401|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 5 mcg qd minus Placebo|||0.401|0.287|<0.0001
72527235|NCT01040728|144584748|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.353|STANDARD_ERROR_OF_MEAN|0.029|<|0.0001||95.0|0.296|0.411|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 10 mcg qd minus Placebo|||0.411|0.296|<0.0001
72527236|NCT01040728|144584748|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.37|STANDARD_ERROR_OF_MEAN|0.029|<|0.0001||95.0|0.314|0.427|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Tio 18 mcg qd minus Placebo|||0.427|0.314|<0.0001
72527237|NCT01040728|144584749|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.334|STANDARD_ERROR_OF_MEAN|0.031|<|0.0001||95.0|0.272|0.396|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 5 mcg qd minus Placebo|||0.396|0.272|<0.0001
72527238|NCT01040728|144584749|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.346|STANDARD_ERROR_OF_MEAN|0.032|<|0.0001||95.0|0.283|0.408|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 10 mcg qd minus Placebo|||0.408|0.283|<0.0001
72527239|NCT01040728|144584749|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.378|STANDARD_ERROR_OF_MEAN|0.031|<|0.0001||95.0|0.316|0.44|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Tio 18 mcg qd minus Placebo|||0.440|0.316|<0.0001
72527240|NCT01040728|144584750|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.244|STANDARD_ERROR_OF_MEAN|0.033|<|0.0001||95.0|0.179|0.309|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 5 mcg qd minus Placebo|||0.309|0.179|<0.0001
72407261|NCT02346240|144323012|SUPERIORITY||Estimated difference in responder rate|8.0|||||TWO_SIDED|95.0|-2.9|18.9|||Regression, Logistic|Estimated responder rate, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure|Estimate and 95 % CI for difference in proportion of responders for CZP 200 mg Q2W (RS) versus Etanercept Q2W (RS).|The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||18.9|-2.9|
72407262|NCT02346240|144323012|SUPERIORITY||Odds Ratio (OR)|1.756|||=|0.0152|TWO_SIDED|95.0|1.114|2.768||The p-value is evaluated at a 2-sided significance level for CZP 400 mg vs. ETN.|Regression, Logistic|Odds ratios, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.||The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||2.768|1.114|=0.0152
72527241|NCT01040728|144584750|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.216|STANDARD_ERROR_OF_MEAN|0.033|<|0.0001||95.0|0.15|0.282|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 10 mcg qd minus Placebo|||0.282|0.150|<0.0001
72527242|NCT01040728|144584750|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.256|STANDARD_ERROR_OF_MEAN|0.033|<|0.0001||95.0|0.191|0.321|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Tio 18 mcg qd minus Placebo|||0.321|0.191|<0.0001
72527243|NCT02871570|144584803|OTHER||ratio|0.7789|||||TWO_SIDED|90.0|0.6514|0.9313|||||Moderate hepatic impairment group represents the numerator, and normal hepatic function group represents the denominator.|||0.9313|0.6514|
72527244|NCT02871570|144584804|OTHER||ratio|0.7776|||||TWO_SIDED|90.0|0.6493|0.9311|||||Moderate hepatic impairment group represents the numerator, and normal hepatic function group represents the denominator.|||0.9311|0.6493|
72527245|NCT02871570|144584805|OTHER||ratio|1.2844|||||TWO_SIDED|90.0|1.0732|1.5372|||||Moderate hepatic impairment group represents the numerator, and normal hepatic function group represents the denominator.|||1.5372|1.0732|
72527246|NCT02871570|144584806|OTHER||ratio|0.7945|||||TWO_SIDED|90.0|0.5955|1.0599|||||Moderate hepatic impairment group represents the numerator, and normal hepatic function group represents the denominator.|||1.0599|0.5955|
72527247|NCT02545049|144584845|SUPERIORITY||Hazard Ratio (HR)|0.87||||0.0264|TWO_SIDED|95.0|0.76|0.98||A hierarchical testing procedure was used for the primary and secondary efficacy endpoints with each variable being tested at the adjusted two-sided significance level of 0.04967388.|Log Rank|Stratified log rank test|A stratified Cox proportional hazards regression model was used to provide a point estimate of the hazard ratio and a corresponding two-sided 95% confidence interval.|||0.98|0.76|0.0264
72527248|NCT02545049|144584846|SUPERIORITY|If the treatment effect of the 40% renal composite endpoint was not significant, all other endpoints (i.e. all-cause hospitalization, all-cause mortality, change in UACR from baseline to Month 4, and 57% renal composite endpoint) would be tested in an exploratory manner.|Hazard Ratio (HR)|0.87||||0.0689|TWO_SIDED|95.0|0.76|1.01||A hierarchical testing procedure was used for the primary and secondary efficacy endpoints with each variable being tested at the adjusted two-sided significance level of 0.04967388.|Log Rank|Stratified log rank test|A stratified Cox proportional hazards regression model was used to provide a point estimate of the hazard ratio and a corresponding two-sided 95% confidence interval.|||1.01|0.76|0.0689
72527249|NCT02545049|144584847|SUPERIORITY|If the treatment effect of the 40% renal composite endpoint was not significant, all other endpoints (i.e. all-cause hospitalization, all-cause mortality, change in UACR from baseline to Month 4, and 57% renal composite endpoint) would be tested in an exploratory manner.|Hazard Ratio (HR)|0.97||||0.3558|TWO_SIDED|95.0|0.9|1.04||A hierarchical testing procedure was used for the primary and secondary efficacy endpoints with each variable being tested at the adjusted two-sided significance level of 0.04967388.|Log Rank|Stratified log rank test|A stratified Cox proportional hazards regression model was used to provide a point estimate of the hazard ratio and a corresponding two-sided 95% confidence interval.|||1.04|0.90|0.3558
72527250|NCT02545049|144584848|SUPERIORITY|If the treatment effect of the 40% renal composite endpoint was not significant, all other endpoints (i.e. all-cause hospitalization, all-cause mortality, change in UACR from baseline to Month 4, and 57% renal composite endpoint) would be tested in an exploratory manner.|Hazard Ratio (HR)|0.89||||0.1337|TWO_SIDED|95.0|0.77|1.04||A hierarchical testing procedure was used for the primary and secondary efficacy endpoints with each variable being tested at the adjusted two-sided significance level of 0.04967388.|Log Rank|Stratified log rank test|A stratified Cox proportional hazards regression model was used to provide a point estimate of the hazard ratio and a corresponding two-sided 95% confidence interval.|||1.04|0.77|0.1337
72527251|NCT02545049|144584849|SUPERIORITY|If the treatment effect of the 40% renal composite endpoint was not significant, all other endpoints (i.e. all-cause hospitalization, all-cause mortality, change in UACR from baseline to Month 4, and 57% renal composite endpoint) would be tested in an exploratory manner.|Ratio of least squares means|0.676|||<|0.0001|TWO_SIDED|95.0|0.65|0.704||P-value from F-test of equal means between the treatment groups. A hierarchical testing procedure was used for the primary and secondary efficacy endpoints with each variable being tested at the adjusted two-sided significance level of 0.04967388.|ANCOVA|||||0.704|0.650|<0.0001
72527252|NCT02545049|144584850|SUPERIORITY|If the treatment effect of the 40% renal composite endpoint was not significant, all other endpoints (i.e. all-cause hospitalization, all-cause mortality, change in UACR from baseline to Month 4, and 57% renal composite endpoint) would be tested in an exploratory manner.|Hazard Ratio (HR)|0.77||||0.0406|TWO_SIDED|95.0|0.6|0.99||A hierarchical testing procedure was used for the primary and secondary efficacy endpoints with each variable being tested at the adjusted two-sided significance level of 0.04967388.|Log Rank|Stratified log rank test|A stratified Cox proportional hazards regression model was used to provide a point estimate of the hazard ratio and a corresponding two-sided 95% confidence interval.|||0.99|0.60|0.0406
72527253|NCT01801189|144584851|SUPERIORITY|||||||0.1||||||Threshold for significance was P \<0.05.|t-test, 1 sided|||||||0.10
72527254|NCT01801189|144584851|SUPERIORITY|||||||0.23||||||Threshold for significance \<0.05|t-test, 1 sided|||POD 1||||.23
72527255|NCT01801189|144584851|SUPERIORITY|||||||0.31||||||Threshold for significance \<0.05|t-test, 1 sided|||POD 2||||.31
72527256|NCT03958149|144584868|SUPERIORITY||||||<|0.001|||||||Independent t-test|||||||<0.001
72527257|NCT03958149|144584869|SUPERIORITY||||||<|0.05|||||||Factorial Mixed ANOVA|||||||<0.05
72527258|NCT00211536|144584899|NON_INFERIORITY_OR_EQUIVALENCE|For the average A1C, the goal was to show non-inferiority of MIP compared to SC. The minimal clinically relevant increase in A1C (%) was set at 0.50%. The between-subjects standard deviation of A1C was assumed to be 1.0% based on previous studies.|Least square means|0.3|STANDARD_ERROR_OF_MEAN|0.2|<|0.05|ONE_SIDED|95.0||0.5|||Mixed Models Analysis|Repeated measures analysis of variance, adjusting for baseline A1C using SAS Proc Mixed to compare A1C trends over time between the treatment groups||Sample size calculations were performed on the primary endpoint: the average glycosylated hemoglobin (A1C). Sample size was estimated using a two-sample, one-sided t-test with a significance level of 0.05. The projected sample size of 50 subjects per treatment group provides 79% power to reject the null hypothesis in favor of the alternative hypothesis that the average A1C in both the MIP and SC groups are equivalent, assuming an effect size of 0.50% and a standard deviation of 1.0%.||0.5||<0.05
72527259|NCT00003389|144584904|SUPERIORITY_OR_OTHER_LEGACY|||||||0.32|TWO_SIDED||||||Log Rank|Stratified log rank test was performed.||||||0.32
72527260|NCT00003389|144584905|SUPERIORITY_OR_OTHER_LEGACY|||||||0.86|TWO_SIDED||||||Log Rank|Stratified log rank test was performed.||||||0.86
72527261|NCT00908050|144584907|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0394|||||||Chi-squared|||The averaged data calculated from three nights in each recording period for each subject will be submitted to statistical analysis. Descriptive and non-parametric statistics will be used for the secondary end-points.||||0.0394
72527262|NCT00935766|144584940|SUPERIORITY_OR_OTHER|||||||0.21|||||||Mixed Models Analysis|||||||0.21
72527263|NCT00935766|144584941|SUPERIORITY_OR_OTHER|||||||0.08|||||||Mixed Models Analysis|||||||0.08
72527264|NCT00935766|144584942|SUPERIORITY_OR_OTHER|||||||0.36|||||||Mixed Models Analysis|||||||0.36
72527265|NCT03347279|144584965|SUPERIORITY||Rate Ratio|0.44|||<|0.001|TWO_SIDED|95.0|0.37|0.53|||Negative Binomial|||||0.53|0.37|<0.001
72527266|NCT03347279|144584966|SUPERIORITY||Rate Ratio|0.59|||<|0.001|TWO_SIDED|95.0|0.46|0.75|||Negative Binomial|||||0.75|0.46|<0.001
72527267|NCT03347279|144584967|SUPERIORITY||Least Squares (LS) Mean Difference|0.13|||<|0.001|TWO_SIDED|95.0|0.08|0.18|||Mixed Models Analysis|||||0.18|0.08|<0.001
72527268|NCT03347279|144584968|SUPERIORITY||LS Means Difference|0.33|||<|0.001|TWO_SIDED|95.0|0.2|0.47|||Mixed Models Analysis|||||0.47|0.2|<0.001
72527269|NCT03347279|144584969|SUPERIORITY||LS Means Difference|-0.33|||<|0.001|TWO_SIDED|95.0|-0.46|-0.2|||Mixed Models Analysis|||||-0.2|-0.46|<0.001
72527270|NCT03347279|144584970|SUPERIORITY||LS Means Difference|-0.11||||0.004|TWO_SIDED|95.0|-0.19|-0.04|||Mixed Models Analysis|||||-0.04|-0.19|0.004
72527271|NCT02530281|144585009|OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
72527272|NCT02530281|144585010|OTHER||||||=|0.065|||||||ANCOVA|Ranked ANCOVA||||||=0.065
72527273|NCT02530281|144585011|OTHER||||||=|0.065|||||||ANCOVA|Ranked ANCOVA||||||=0.065
72527274|NCT02530281|144585012|OTHER||||||=|0.001|||||||ANCOVA|Ranked ANCOVA||||||=0.001
72527275|NCT02530281|144585013|OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
72527276|NCT02530281|144585014|OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
72527277|NCT02200510|144585068|EQUIVALENCE|Because this was a pilot study, the goal was to detect effects sizes for a larger R01 or R21.|Mean Difference (Final Values)|0.33||||0.575|TWO_SIDED||||||ANOVA|||||||0.575
72527278|NCT02200510|144585068|EQUIVALENCE|Because this was a pilot study, the goal was to detect effects sizes for a larger R01 or R21.|Mean Difference (Final Values)|0.138||||0.721|TWO_SIDED||||||ANOVA|||||||0.721
72527279|NCT00290355|144585069|OTHER||Hazard Ratio (HR)|0.74||||0.256|TWO_SIDED|95.0|0.44|1.24||Two-sided p value from Cox regression model adjusted for covariate(s) node/squam/stage to test the null hypothesis was: the distribution of time to recurrences was the same in each group (H0 = \[HR=1\]).|Regression, Cox|The p value by log rank test was 0.1995. Criterion for evaluation of the objective: one sided p-value \< 10%||Hazard ratio of GSK 249553 study product.||1.24|0.44|0.256
72527280|NCT03502941|144585099|SUPERIORITY||||||<|0.05||||||P value was calculated.|t-test, 2 sided|||||||<0.05
72527281|NCT03502941|144585100|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<0.05
72527282|NCT01072500|144585108|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.82||||0.03|TWO_SIDED|95.0|0.69|0.98|||Regression, Cox|To compare interventions, we used a likelihood ratio test from a Cox regression model, stratified by field center and sex.||||0.98|0.69|0.03
72527283|NCT01072500|144585109|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.72||||0.006|TWO_SIDED|95.0|0.57|0.91|||Regression, Cox|||||0.91|0.57|0.006
72527284|NCT03798366|144585110|SUPERIORITY||Least square (LS) mean difference|-0.5|STANDARD_ERROR_OF_MEAN|1.29||0.6757|TWO_SIDED|95.0|-3.1|2.0|||Mixed Models Analysis||A negative difference indicates a greater improvement in the GLPG1690 treatment group.|Results were estimated using a mixed-effect model repeated measure using treatment and visit as fixed effects, baseline mRSS score and country as covariates, treatment-visit as interaction terms, and participant as a random effect. The variance-covariance matrix used in the model was compound symmetric.||2.0|-3.1|0.6757
72527285|NCT03798366|144585111|SUPERIORITY||LS mean difference|-0.7|STANDARD_ERROR_OF_MEAN|1.31||0.6079|TWO_SIDED|95.0|-3.3|1.9|||Mixed Models Analysis||A negative difference indicates a greater improvement in the GLPG1690 treatment group.|Results were estimated using a mixed-effect model repeated measure using treatment and visit as fixed effects, baseline mRSS score and country as covariates, treatment-visit as interaction terms, and participant as a random effect. The variance-covariance matrix used in the model was compound symmetric.||1.9|-3.3|0.6079
72571466|NCT00117325|144671702|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.566||||0.011|TWO_SIDED|95.0|-1.0|-0.13|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for rTNSS at Day 16||-0.13|-1.00|0.011
72571467|NCT00117325|144671702|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.59||||0.009|TWO_SIDED|95.0|-1.03|-0.15|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for rTNSS at Day 17||-0.15|-1.03|0.009
72571468|NCT00117325|144671702|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.301||||0.175|TWO_SIDED|95.0|-0.74|0.13|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for rTNSS at Day 18||0.13|-0.74|0.175
72527286|NCT03798366|144585112|SUPERIORITY||LS mean difference|-2.1|STANDARD_ERROR_OF_MEAN|1.35||0.1298|TWO_SIDED|95.0|-4.8|0.6|||Mixed Models Analysis||A negative difference indicates a greater improvement in the GLPG1690 treatment group.|Results were estimated using a mixed-effect model repeated measure using treatment and visit as fixed effects, baseline mRSS score and country as covariates, treatment-visit as interaction terms, and participant as a random effect. The variance-covariance matrix used in the model was compound symmetric.||0.6|-4.8|0.1298
72527287|NCT03798366|144585113|SUPERIORITY||LS mean difference|-2.8|STANDARD_ERROR_OF_MEAN|1.36||0.0411|TWO_SIDED|95.0|-5.6|-0.1|||Mixed Models Analysis||A negative difference indicates a greater improvement in the GLPG1690 treatment group.|Results were estimated using a mixed-effect model repeated measure using treatment and visit as fixed effects, baseline mRSS score and country as covariates, treatment-visit as interaction terms, and participant as a random effect. The variance-covariance matrix used in the model was compound symmetric.||-0.1|-5.6|0.0411
72527288|NCT01642004|144585115|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.59||||0.0002|TWO_SIDED|96.85|0.43|0.81||Stratified by region (US/Canada, Rest Of World (ROW), Europe) and prior treatment regimen (Paclitaxel, Another agent) as entered in the Interactive Voice Response System (IVRS).|Log Rank||Stratified Cox proportional hazard model. HR = Nivolumab over Docetaxel|||0.81|0.43|0.0002
72527289|NCT01603628|144585188|SUPERIORITY||Least Squares (LS) Mean Difference|-0.26||||0.01|TWO_SIDED|95.0|-0.453|-0.063||MMRM including baseline MAS-B ankle score (knee extended) as a covariate and factors of age, treatment, visit, treatment-by-visit interaction, study center and previous botulinum toxin exposure where age is represented by stratification categories.|Mixed Model Repeated Measures|||||-0.063|-0.453|0.010
72527290|NCT01603628|144585188|SUPERIORITY||LS Mean Difference|-0.21||||0.033|TWO_SIDED|95.0|-0.405|-0.018||MMRM including baseline MAS-B ankle score (knee extended) as a covariate and factors of age, treatment, visit, treatment-by-visit interaction, study center and previous botulinum toxin exposure where age is represented by stratification categories.|Mixed Model Repeated Measures|||||-0.018|-0.405|0.033
72527291|NCT01603628|144585189|SUPERIORITY||LS Mean Difference|0.29||||0.023|TWO_SIDED|95.0|0.04|0.532||MMRM including baseline MAS-B ankle score (knee extended) as a covariate and factors of age, treatment, visit, treatment-by-visit interaction, study center and previous botulinum toxin exposure where age is represented by stratification categories.|Mixed Model Repeated Measures|||||0.532|0.040|0.023
72527292|NCT01603628|144585189|SUPERIORITY||LS Mean Difference|0.13||||0.299|TWO_SIDED|95.0|-0.115|0.374||MMRM including baseline MAS-B ankle score (knee extended) as a covariate and factors of age, treatment, visit, treatment-by-visit interaction, study center and previous botulinum toxin exposure where age is represented by stratification categories.|Mixed Model Repeated Measures|||||0.374|-0.115|0.299
72527293|NCT01603628|144585190|SUPERIORITY||LS Mean Difference|0.41||||0.005|TWO_SIDED|95.0|0.126|0.704||ANCOVA model including baseline MAS-B ankle score with knee extended as a covariate and factors of age group, treatment group, study center and previous botulinum toxin exposure where age group is represented by stratification categories.|ANCOVA|||Week 8, Active Goal||0.704|0.126|0.005
72527294|NCT01603628|144585190|SUPERIORITY||LS Mean Difference|0.29||||0.047|TWO_SIDED|95.0|0.004|0.573||ANCOVA model including baseline MAS-B ankle score with knee extended as a covariate and factors of age group, treatment group, study center and previous botulinum toxin exposure where age group is represented by stratification categories.|ANCOVA|||Week 8, Active Goal||0.573|0.004|0.047
72527295|NCT01603628|144585190|SUPERIORITY||LS Mean Difference|0.45||||0.004|TWO_SIDED|95.0|0.145|0.756||ANCOVA model including baseline MAS-B ankle score with knee extended as a covariate and factors of age group, treatment group, study center and previous botulinum toxin exposure where age group is represented by stratification categories.|ANCOVA|||Week 8, Passive Goal||0.756|0.145|0.004
72527296|NCT01603628|144585190|SUPERIORITY||LS Mean Difference|0.44||||0.004|TWO_SIDED|95.0|0.141|0.74||ANCOVA model including baseline MAS-B ankle score with knee extended as a covariate and factors of age group, treatment group, study center and previous botulinum toxin exposure where age group is represented by stratification categories.|ANCOVA|||Week 8, Passive Goal||0.740|0.141|0.004
72527297|NCT01603628|144585190|SUPERIORITY||LS Mean Difference|0.49||||0.001|TWO_SIDED|95.0|0.191|0.797||ANCOVA model including baseline MAS-B ankle score with knee extended as a covariate and factors of age group, treatment group, study center and previous botulinum toxin exposure where age group is represented by stratification categories.|ANCOVA|||Week 12, Active Goal||0.797|0.191|0.001
72527298|NCT01603628|144585190|SUPERIORITY||LS Mean Difference|0.22||||0.153|TWO_SIDED|95.0|-0.081|0.541||ANCOVA model including baseline MAS-B ankle score with knee extended as a covariate and factors of age group, treatment group, study center and previous botulinum toxin exposure where age group is represented by stratification categories.|ANCOVA|||Week 12, Active Goal||0.541|-0.081|0.153
72571469|NCT00117325|144671702|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.449||||0.039|TWO_SIDED|95.0|-0.87|-0.02|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for rTNSS at Day 19||-0.02|-0.87|0.039
72527299|NCT01603628|144585190|SUPERIORITY||LS Mean Difference|0.41||||0.01|TWO_SIDED|95.0|0.1|0.711||ANCOVA model including baseline MAS-B ankle score with knee extended as a covariate and factors of age group, treatment group, study center and previous botulinum toxin exposure where age group is represented by stratification categories.|ANCOVA|||Week 12, Passive Goal||0.711|0.100|0.010
72571470|NCT00117325|144671702|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.315||||0.152|TWO_SIDED|95.0|-0.75|0.12|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for rTNSS at Day 20||0.12|-0.75|0.152
72527300|NCT01603628|144585190|SUPERIORITY||LS Mean Difference|0.27||||0.078|TWO_SIDED|95.0|-0.031|0.571||ANCOVA model including baseline MAS-B ankle score with knee extended as a covariate and factors of age group, treatment group, study center and previous botulinum toxin exposure where age group is represented by stratification categories.|ANCOVA|||Week 12, Passive Goal||0.571|-0.031|0.078
72527301|NCT01603628|144585191|SUPERIORITY||LS Mean Difference|-1.99||||0.158|TWO_SIDED|95.0|-4.768|0.779||ANCOVA model including baseline MTS ankle score with knee extended as a covariate and factors of age group, treatment group, study center, and previous botulinum toxin exposure where age group is represented by stratification categories.|ANCOVA|||Change from Baseline to Week 2||0.779|-4.768|0.158
72527302|NCT01603628|144585191|SUPERIORITY||LS Mean Difference|-3.25||||0.02|TWO_SIDED|95.0|-5.974|-0.524||ANCOVA model including baseline MTS ankle score with knee extended as a covariate and factors of age group, treatment group, study center, and previous botulinum toxin exposure where age group is represented by stratification categories.|ANCOVA|||Change from Baseline to Week 2||-0.524|-5.974|0.020
72527303|NCT01603628|144585191|SUPERIORITY||LS Mean Difference|-1.42||||0.363|TWO_SIDED|95.0|-4.489|1.648||ANCOVA model including baseline MTS ankle score with knee extended as a covariate and factors of age group, treatment group, study center, and previous botulinum toxin exposure where age group is represented by stratification categories.|ANCOVA|||Change from Baseline to Week 4||1.648|-4.489|0.363
72527304|NCT01603628|144585191|SUPERIORITY||LS Mean Difference|-2.11||||0.171|TWO_SIDED|95.0|-5.127|0.914||ANCOVA model including baseline MTS ankle score with knee extended as a covariate and factors of age group, treatment group, study center, and previous botulinum toxin exposure where age group is represented by stratification categories.|ANCOVA|||Change from Baseline to Week 4||0.914|-5.127|0.171
72369359|NCT00806819|144248651|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.37||||0.0387|TWO_SIDED|95.0|1.02|1.85||Odds ratio and p-value are obtained from logistic regression model adjusted for baseline ECOG PS (0 vs 1)|Regression, Logistic||An odds ratio \>1 indicates a benefit to nintedanib|Analysis based on the central independent review||1.85|1.02|0.0387
72369360|NCT00806819|144248651|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.29||||0.1071|TWO_SIDED|95.0|0.95|1.75||Odds ratio and p-value are obtained from logistic regression model adjusted for baseline ECOG PS (0 vs 1)|Regression, Logistic||An odds ratio \>1 indicates a benefit to nintedanib|Analysis based on investigator's assessment||1.75|0.95|0.1071
72369361|NCT00806819|144248653|SUPERIORITY_OR_OTHER|||||||0.1558|TWO_SIDED|||||P-value generated from ANOVA model adjusted for baseline ECOG PS (0 vs. 1), tumour histology (adenocarcinoma vs. non-adenocarcinoma), brain metastases at baseline (yes vs no) and prior treatment with bevacizumab (yes vs no)|ANOVA|||Analysis based on the central independent review||||0.1558
72369362|NCT00806819|144248653|SUPERIORITY_OR_OTHER|||||||0.0565|TWO_SIDED|||||P-value generated from ANOVA model adjusted for baseline ECOG PS (0 vs. 1), tumour histology (adenocarcinoma vs. non-adenocarcinoma), brain metastases at baseline (yes vs no) and prior treatment with bevacizumab (yes vs no)|ANOVA|||Analysis based on the investigator's assessment||||0.0565
72369363|NCT00806819|144248654|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.93||||0.5068|TWO_SIDED|95.0|0.74|1.16|||Regression, Cox||HR below 1 favors nintedanib|HR, CI and p-value obtained from the proportional hazards model stratified by baseline ECOG PS (0 vs 1), tumour histology (adenocarcinoma vs. non-adenocarcinoma), brain metastases at baseline (yes vs no) and prior treatment with bevacizumab (yes vs no).||1.16|0.74|0.5068
72369364|NCT00806819|144248655|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.83||||0.1181|TWO_SIDED|95.0|0.66|1.05|||Regression, Cox||HR below 1 favors nintedanib|Analysis evaluating the time to deterioration of cough. HR, CI and p-value obtained from the prop. hazards model stratified by baseline ECOG PS (0 vs \>=1), tumour histology (adenocarcinoma vs. non-adenocarcinoma), brain metastases at baseline (yes vs no) and prior treatment with bevacizumab (yes vs no)||1.05|0.66|0.1181
72527305|NCT01603628|144585191|SUPERIORITY||LS Mean Difference|-3.33||||0.02|TWO_SIDED|95.0|-6.143|-0.525||ANCOVA model including baseline MTS ankle score with knee extended as a covariate and factors of age group, treatment group, study center, and previous botulinum toxin exposure where age group is represented by stratification categories.|ANCOVA|||Change from Baseline to Week 6||-0.525|-6.143|0.020
72527306|NCT01603628|144585191|SUPERIORITY||LS Mean Difference|-3.92||||0.006|TWO_SIDED|95.0|-6.688|-1.148||ANCOVA model including baseline MTS ankle score with knee extended as a covariate and factors of age group, treatment group, study center, and previous botulinum toxin exposure where age group is represented by stratification categories.|ANCOVA|||Change from Baseline to Week 6||-1.148|-6.688|0.006
72527307|NCT01603628|144585191|SUPERIORITY||LS Mean Difference|-2.07||||0.254|TWO_SIDED|95.0|-5.621|1.491||ANCOVA model including baseline MTS ankle score with knee extended as a covariate and factors of age group, treatment group, study center, and previous botulinum toxin exposure where age group is represented by stratification categories.|ANCOVA|||Change from Baseline to Week 8||1.491|-5.621|0.254
72527308|NCT01603628|144585191|SUPERIORITY||LS Mean Difference|-2.46||||0.165|TWO_SIDED|95.0|-5.935|1.014||ANCOVA model including baseline MTS ankle score with knee extended as a covariate and factors of age group, treatment group, study center, and previous botulinum toxin exposure where age group is represented by stratification categories.|ANCOVA|||Change from Baseline to Week 8||1.014|-5.935|0.165
72527309|NCT01603628|144585191|SUPERIORITY||LS Mean Difference|-2.61||||0.078|TWO_SIDED|95.0|-5.517|0.296||ANCOVA model including baseline MTS ankle score with knee extended as a covariate and factors of age group, treatment group, study center, and previous botulinum toxin exposure where age group is represented by stratification categories.|ANCOVA|||Change from Baseline to Week 12||0.296|-5.517|0.078
72527310|NCT01603628|144585191|SUPERIORITY||LS Mean Difference|-1.09||||0.451|TWO_SIDED|95.0|-3.944|1.758||ANCOVA model including baseline MTS ankle score with knee extended as a covariate and factors of age group, treatment group, study center, and previous botulinum toxin exposure where age group is represented by stratification categories.|ANCOVA|||Change from Baseline to Week 12||1.758|-3.944|0.451
72527311|NCT02120469|144585236|OTHER||||||||||||||||||Dose level B1 (eribulin 1.1 mg/m2 days 1 and 8 every 3 weeks with everolimus 5 mg daily) was defined as the highest dose with acceptable toxicity (RP2D).|||
72527312|NCT01369069|144585269|SUPERIORITY||Risk Ratio (RR)|0.97||||0.55|TWO_SIDED|95.0|0.87|1.08||The a priori threshold for statistical significance was 0.05.|Regression, Logistic||Adjusted for baseline NIHSS strata (3-7, 8-14, 15-22) and thrombolysis use (Yes/No; includes both IV and IA therapies). Multiple imputation was used for missing data.|It was hypothesized that intensive blood glucose control would be efficacious and safe in acute ischemic stroke patients compared to standard glucose control.||1.08|0.87|0.55
72527313|NCT01369069|144585270|SUPERIORITY||Risk Difference (RD)|2.58|||<|0.001|TWO_SIDED|95.0|1.29|3.87|||Fisher Exact||The data of the estimation parameter and the confidence intervals were presented as percentages.|||3.87|1.29|<0.001
72527314|NCT01369069|144585271|SUPERIORITY||Risk Difference (RD)|-1.07||||0.77|TWO_SIDED|95.0|-8.33|6.2|||Chi-squared||The data of the estimation parameter and the confidence intervals were presented as percentages.|||6.20|-8.33|0.77
72527315|NCT01369069|144585272|SUPERIORITY||Risk Difference (RD)|0.48||||0.88|TWO_SIDED|95.0|-5.79|6.75|||Chi-squared||The data of the estimation parameter and the confidence intervals were presented as percentages.|||6.75|-5.79|0.88
72527316|NCT01369069|144585273|SUPERIORITY||Median Difference (Final Values)|0.06||||0.74|TWO_SIDED|95.0|-0.13|0.25|||Wilcoxon (Mann-Whitney)|||||0.25|-0.13|0.74
72527317|NCT01369069|144585274|SUPERIORITY||Risk Ratio (RR)|0.82||||0.24|TWO_SIDED|95.0|0.58|1.15|||Chi-squared|||||1.15|0.58|0.24
72527318|NCT01846208|144585276|SUPERIORITY||Risk Difference (RD)|32.4||||0.009|TWO_SIDED|95.0|8.9|55.8|||Barnard's Exact Test|||% participants passed Year 2 SU OFC: Baked vs. Egg OIT-Randomized||55.8|8.9|0.009
72571471|NCT00117325|144671702|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.424||||0.063|TWO_SIDED|95.0|-0.87|0.02|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for rTNSS at Day 21||0.02|-0.87|0.063
72571472|NCT00117325|144671702|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.454||||0.044|TWO_SIDED|95.0|-0.9|-0.01|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for rTNSS at Day 22||-0.01|-0.90|0.044
72571473|NCT00117325|144671702|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.312||||0.179|TWO_SIDED|95.0|-0.77|0.14|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for rTNSS at Day 23||0.14|-0.77|0.179
72571474|NCT00117325|144671702|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.479||||0.034|TWO_SIDED|95.0|-0.92|-0.04|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for rTNSS at Day 24||-0.04|-0.92|0.034
72571475|NCT00117325|144671702|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.157||||0.505|TWO_SIDED|95.0|-0.62|0.31|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for rTNSS at Day 25||0.31|-0.62|0.505
72527319|NCT01846208|144585276|SUPERIORITY||Risk Difference (RD)|25.5||||0.031|TWO_SIDED|95.0|2.0|49.1|||Barnard's Exact Test|||% participants passed Year 2 SU OFC: Egg OIT-Randomized vs. Egg OIT-Assigned||49.1|2.0|0.031
72527320|NCT01846208|144585277|SUPERIORITY||Risk Difference (RD)|64.7|||<|0.0001|TWO_SIDED|95.0|43.9|85.6|||Barnard's Exact Test|||% participants desensitized to \>=4444 mg at Year 2 OFC: Baked vs. Egg OIT-Randomized||85.6|43.9|<0.0001
72527321|NCT01846208|144585277|SUPERIORITY||Risk Difference (RD)|17.7||||0.151|TWO_SIDED|95.0|-2.3|37.7|||Barnard's Exact Test|||% participants desensitized to \>=4444 mg at Year 2 OFC: Egg OIT-Randomized vs. Egg OIT-Assigned||37.7|-2.3|0.151
72527322|NCT01846208|144585277|SUPERIORITY||Risk Difference (RD)|44.3||||0.002|TWO_SIDED|95.0|19.4|69.2|||Barnard's Exact Test|||% participants desensitized to \>=4444 mg at Year 1 OFC: Baked vs. Egg OIT-Randomized||69.2|19.4|0.002
72407263|NCT02346240|144323012|SUPERIORITY||Odds Ratio (OR)|1.388|||=|0.1523|TWO_SIDED|95.0|0.886|2.175||The p-value is evaluated at a 2-sided significance level for CZP 200 mg vs. ETN|Regression, Logistic|Odds ratios, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.||The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||2.175|0.886|=0.1523
72407264|NCT02346240|144323013|SUPERIORITY||Estimated difference in responder rate|48.5|||||TWO_SIDED|95.0|39.33|57.63|||Regression, Logistic|Estimated responder rate, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.|Estimate and 95 % CI for difference in proportion of responders for CZP 400 mg Q2W (RS) versus Placebo Q2W (RS).|The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||57.63|39.33|
72527323|NCT01846208|144585277|SUPERIORITY||Risk Difference (RD)|17.5||||0.181|TWO_SIDED|95.0|-6.3|41.3|||Barnard's Exact Test|||% participants desensitized to \>=4444 mg at Year 1 OFC: Egg OIT-Randomized vs. Egg OIT-Assigned||41.3|-6.3|0.181
72527324|NCT01846208|144585279|SUPERIORITY||Risk Difference (RD)|-50.2||||0.003|TWO_SIDED|95.0|-78.4|-21.9|||Barnard's Exact Test|||% participants with unrestricted consumption of unbaked (concentrated) egg 3 years after randomization: Baked vs. Egg OIT-Randomized||-21.9|-78.4|0.003
72527325|NCT01846208|144585279|SUPERIORITY||Risk Difference (RD)|33.7||||0.023|TWO_SIDED|95.0|7.2|60.1|||Barnard's Exact Test|||% participants with unrestricted consumption of unbaked (concentrated) egg 3 years after randomization: Egg OIT-Randomized vs. Egg OIT-Assigned||60.1|7.2|0.023
72527326|NCT01424306|144585287|OTHER|||||||0.403||||||P value for the time x diet interaction reflects overall comparison of 3 dietary phases by RM-ANOVA|RM-ANOVA|||RM-ANOVA||||0.403
72527327|NCT01424306|144585288|OTHER|RM-ANOVA||||||0.933||||||P-diet: reflects an overall comparison of the 3 dietary phases by RM-ANOVA|RM-ANOVA|||||||0.933
72527328|NCT01424306|144585289|OTHER|RM-ANOVA||||||0.196||||||P-diet: reflects an overall comparison of the 3 dietary phases by RM-ANOVA|RM-ANOVA|||||||0.196
72527329|NCT01424306|144585290|OTHER|RM-ANOVA||||||0.88||||||Reflects an overall comparison of the 3 dietary phases by RM-ANOVA|RM-ANOVA|||||||0.880
72527330|NCT01424306|144585291|OTHER|RM-ANOVA|||||<|0.001||||||P-value reflects an overall comparison of the 3 dietary phases by RM-ANOVA|Repeated measures ANOVA|||||||<0.001
72527331|NCT01424306|144585292|OTHER|RM-ANOVA||||||0.366||||||P-value reflects an overall comparison of the 3 dietary phases by RM-ANOVA|RM-ANOVA|||||||0.366
72527332|NCT01424306|144585293|OTHER|RM-ANOVA||||||0.387||||||P-value reflects overall comparison of the 3 dietary phases by RM-ANOVA|RM-ANOVA|||||||0.387
72527333|NCT01424306|144585294|OTHER|RM-ANOVA||||||0.476||||||P-value reflects overall comparison of the 3 dietary phases by RM-ANOVA|RM-ANOVA|||||||0.476
72527334|NCT01424306|144585295|OTHER|RM-ANOVA||||||0.596||||||P-value reflects overall comparison of the 3 dietary phases by RM-ANOVA|RM-ANOVA|||||||0.596
72527335|NCT01424306|144585296|OTHER|RM-ANOVA||||||0.492||||||P-value reflects overall comparison of the 3 dietary phases by RM-ANOVA|RM-ANOVA|||||||0.492
72527336|NCT01424306|144585297|OTHER|RM-ANOVA||||||0.149||||||P-value reflects overall comparison of the 3 dietary phases by RM-ANOVA|RM-ANOVA|||||||0.149
72527337|NCT01424306|144585298|OTHER|RM-ANOVA||||||0.056||||||P-value reflects overall comparison of the 3 dietary phases by RM-ANOVA|RM-ANOVA|||||||0.056
72527338|NCT01424306|144585299|OTHER|RM-ANOVA||||||0.52||||||P-value reflects overall comparison of the 3 dietary phases by RM-ANOVA|RM-ANOVA|||||||0.520
72527339|NCT00369928|144585300|SUPERIORITY_OR_OTHER||Odds Ratio, log|0.88||||0.982|TWO_SIDED|80.0|0.56|1.38|||Cochran-Mantel-Haenszel|||||1.38|0.56|0.982
72527340|NCT00369928|144585300|SUPERIORITY_OR_OTHER||Odds Ratio, log|0.79||||0.666|TWO_SIDED|80.0|0.5|1.25|||Cochran-Mantel-Haenszel|||||1.25|0.50|0.666
72527341|NCT01809327|144585308|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-0.46|STANDARD_ERROR_OF_MEAN|0.099||0.001|TWO_SIDED|95.0|-0.657|-0.269|||Mixed Model for Repeated Measures (MMRM)|||||-0.269|-0.657|0.001
72527342|NCT01809327|144585308|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-0.48|STANDARD_ERROR_OF_MEAN|0.099||0.001|TWO_SIDED|95.0|-0.67|-0.28|||Mixed Model for Repeated Measures (MMRM)|||||-0.280|-0.670|0.001
72527343|NCT01809327|144585308|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.099||0.001|TWO_SIDED|95.0|-0.594|-0.207|||Mixed Model for Repeated Measures (MMRM)|||||-0.207|-0.594|0.001
72527344|NCT01809327|144585308|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-0.36|STANDARD_ERROR_OF_MEAN|0.099||0.001|TWO_SIDED|95.0|-0.557|-0.169|||Mixed Model for Repeated Measures (MMRM)|||||-0.169|-0.557|0.001
72527345|NCT01809327|144585308|NON_INFERIORITY_OR_EQUIVALENCE|P value corresponds to a comparison that canagliflozin is noninferior to Metformin XR by a margin of 0.35%.|Least-Squares Mean Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.1||0.001|TWO_SIDED|95.0|-0.258|0.133|||Mixed Model for Repeated Measures (MMRM)|||||0.133|-0.258|0.001
72527346|NCT01809327|144585308|NON_INFERIORITY_OR_EQUIVALENCE|P value corresponds to a comparison that canagliflozin is noninferior to Metformin XR by a margin of 0.35%.|Least-Squares Mean Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.099||0.001|TWO_SIDED|95.0|-0.307|0.082|||Mixed Model for Repeated Measures (MMRM)|||||0.082|-0.307|0.001
72527347|NCT01809327|144585309|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|0.4||0.016|TWO_SIDED|95.0|-1.6|-0.2|||Mixed Model for Repeated Measures (MMRM)|||||-0.2|-1.6|0.016
72527348|NCT01809327|144585309|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-1.8|STANDARD_ERROR_OF_MEAN|0.4||0.002|TWO_SIDED|95.0|-2.6|-1.1|||Mixed Model for Repeated Measures (MMRM)|||||-1.1|-2.6|0.002
72527349|NCT01809327|144585309|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-1.4|STANDARD_ERROR_OF_MEAN|0.4||0.001|TWO_SIDED|95.0|-2.1|-0.6|||Mixed Model for Repeated Measures (MMRM)|||||-0.6|-2.1|0.001
72527350|NCT01809327|144585309|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-2.1|STANDARD_ERROR_OF_MEAN|0.4||0.001|TWO_SIDED|95.0|-2.9|-1.4|||Mixed Model for Repeated Measures (MMRM)|||||-1.4|-2.9|0.001
72527351|NCT01809327|144585310|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.58||||0.027|TWO_SIDED|95.0|1.06|2.37|||Generalized Linear Mixed Model|||||2.37|1.06|0.027
72527352|NCT01809327|144585310|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.21||||0.016|TWO_SIDED|95.0|1.46|3.33|||Generalized Linear Mixed Model|||||3.33|1.46|0.016
72527353|NCT01809327|144585311|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-1.91|STANDARD_ERROR_OF_MEAN|0.882||0.06|TWO_SIDED|95.0|-3.641|-0.182|||Mixed Model for Repeated Measures (MMRM)|||||-0.182|-3.641|0.060
72407265|NCT02346240|144323013|SUPERIORITY||Estimated difference in responder rate|37.9|||||TWO_SIDED|95.0|28.88|46.96|||Regression, Logistic|Estimated responder rate, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.|Estimate and 95 % CI for difference in proportion of responders for CZP 200 mg Q2W (RS) versus Placebo Q2W (RS).|The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||46.96|28.88|
72527354|NCT01809327|144585311|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-1.31|STANDARD_ERROR_OF_MEAN|0.889||0.147|TWO_SIDED|95.0|-3.058|0.431|||Mixed Model for Repeated Measures (MMRM)|||||0.431|-3.058|0.147
72527355|NCT01809327|144585312|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|5.3|STANDARD_ERROR_OF_MEAN|2.1||0.147|TWO_SIDED|95.0|1.2|9.5|||ANCOVA|||||9.5|1.2|0.147
72527356|NCT01809327|144585312|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|4.3|STANDARD_ERROR_OF_MEAN|2.1||0.147|TWO_SIDED|95.0|0.2|8.5|||ANCOVA|||||8.5|0.2|0.147
72527357|NCT01809327|144585313|SUPERIORITY_OR_OTHER||Hodges-Lehman Estimate|-3.7||||0.608|TWO_SIDED|95.0|-11.1|3.4|||Wilcoxon (Mann-Whitney)|||||3.4|-11.1|0.608
72527358|NCT01809327|144585313|SUPERIORITY_OR_OTHER||Hodges-Lehman Estimate|1.3||||0.806|TWO_SIDED|95.0|-7.3|10.0|||Wilcoxon (Mann-Whitney)|||||10.0|-7.3|0.806
72527359|NCT02176005|144585330|OTHER||Contrast (B/A)|0.0093|||<|1e-06|TWO_SIDED|95.0|0.006|0.0144|||General linear model|||||0.0144|0.0060|<.000001
72527360|NCT02176005|144585331|OTHER||Contrast (B/A)|0.0096|||<|1e-06|TWO_SIDED|95.0|0.0061|0.0151|||General linear model|||||0.0151|0.0061|<.000001
72527361|NCT02176005|144585332|OTHER||Contrast (B/A)|0.9811||||0.806|TWO_SIDED|95.0|0.8608|1.1182|||General linear model|||||1.1182|0.8608|0.806
72527362|NCT02176005|144585333|OTHER||Contrast (B/A)|0.8785||||0.139|TWO_SIDED|95.0|0.76|1.0155|||General linear model|||||1.0155|0.7600|0.139
72527363|NCT02176005|144585334|OTHER||Contrast (B/A)|1.1763||||0.104|TWO_SIDED|95.0|0.9982|1.3861|||General linear model|||||1.3861|0.9982|0.104
72527364|NCT02176005|144585335|OTHER||Contrast (B/A)|0.9391||||0.519|TWO_SIDED|95.0|0.7969|1.1066|||General linear model|||||1.1066|0.7969|0.519
72571476|NCT00117325|144671702|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.317||||0.186|TWO_SIDED|95.0|-0.79|0.15|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for rTNSS at Day 26||0.15|-0.79|0.186
72571477|NCT00117325|144671702|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.283||||0.234|TWO_SIDED|95.0|-0.75|0.18|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for rTNSS at Day 27||0.18|-0.75|0.234
72527365|NCT02274766|144585340|SUPERIORITY||Least Squares Mean Difference|-14.4|STANDARD_ERROR_OF_MEAN|3.03|<|0.0001|TWO_SIDED|95.0|-20.4|-8.3|||Linear Mixed Model w/ Repeated Measures|Change from baseline is a dependent variable; the baseline value is a continuous covariate||32 subjects per treatment arm provided 90% power using a 2-sided test at 5% significance.||-8.3|-20.4|<0.0001
72527366|NCT02274766|144585341|SUPERIORITY||Least Squares Mean Difference|1.9|STANDARD_ERROR_OF_MEAN|0.775||0.0168|TWO_SIDED|95.0|0.35|3.45||Change from Baseline in ON time without troublesome dyskinesia.|Linear Mixed Model w/ Repeated Measures|||||3.45|0.35|0.0168
72527367|NCT02274766|144585341|SUPERIORITY||Least Squares Mean Difference|-1.13|STANDARD_ERROR_OF_MEAN|0.648||0.0853|TWO_SIDED|95.0|-2.42|0.16||Change from Baseline in ON time with troublesome dyskinesia.|Linear Mixed Model w/ Repeated Measures|||||0.16|-2.42|0.0853
72527368|NCT02274766|144585341|SUPERIORITY||Least Squares Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|0.461||0.0199|TWO_SIDED|95.0|-2.02|-0.18||Change from Baseline in OFF time.|Linear Mixed Model w/ Repeated Measures|||||-0.18|-2.02|0.0199
72527369|NCT03350724|144585361|SUPERIORITY|||||||0.039||||||Unadjusted p-value|Z-Test for Two Population Proportions|Unadjusted p-value||||||0.039
72527370|NCT03350724|144585362|SUPERIORITY|||||||0.037||||||Unadjusted p-value|Z-Test for Two Population Proportions|Unadjusted p-value||||||0.037
72527371|NCT03350724|144585363|SUPERIORITY|||||||0.032|||||||Z-Test for Two Population Proportions|||||||0.032
72527372|NCT03350724|144585364|SUPERIORITY|||||||0.171||||||Unadjusted p-value|Z-Test for Two Population Proportions|Unadjusted p-value||||||0.171
72527373|NCT03350724|144585365|SUPERIORITY|||||||0.484||||||Unadjusted p-value|Z-Test for Two Population Proportions|Unadjusted p-value||||||0.484
72527374|NCT03350724|144585366|SUPERIORITY|||||||0.368||||||Unadjusted p-value|Z-Test for Two Population Proportions|Unadjusted p-value||||||0.368
72527375|NCT03350724|144585367|SUPERIORITY|||||||0.308||||||Unadjusted p-value|Z-Test for Two Population Proportions|Unadjusted p-value||||||0.308
72527376|NCT03350724|144585368|SUPERIORITY|||||||0.999||||||Unadjusted p-value|Z-Test for Two Population Proportions|Unadjusted p-value||||||0.999
72527377|NCT03350724|144585369|SUPERIORITY|||||||0.015||||||Unadjusted p-value|Wilcoxon (Mann-Whitney)|Unadjusted p-value||||||0.015
72527378|NCT03350724|144585370|SUPERIORITY|||||||0.021||||||Unadjusted p-value|Wilcoxon (Mann-Whitney)|Unadjusted p-value||||||0.021
72527379|NCT03350724|144585371|SUPERIORITY|||||||0.035||||||Unadjusted p-value|Wilcoxon (Mann-Whitney)|Unadjusted p-value||||||0.035
72527380|NCT03350724|144585372|SUPERIORITY|||||||0.444||||||Unadjusted p-value|Wilcoxon (Mann-Whitney)|Unadjusted p-value||||||0.444
72527381|NCT03350724|144585373|SUPERIORITY|||||||0.765||||||Unadjusted p-value|Wilcoxon (Mann-Whitney)|Unadjusted p-value||||||0.765
72527382|NCT03350724|144585374|SUPERIORITY|||||||0.941||||||Unadjusted p-value|Wilcoxon (Mann-Whitney)|Unadjusted p-value||||||0.941
72527383|NCT03350724|144585375|SUPERIORITY|||||||0.421||||||Unadjusted p-value|Wilcoxon (Mann-Whitney)|Unadjusted p-value||||||0.421
72527384|NCT03350724|144585376|SUPERIORITY|||||||0.357||||||Unadjusted p-value|Wilcoxon (Mann-Whitney)|Unadjusted p-value||||||0.357
72527385|NCT03350724|144585377|SUPERIORITY|||||||0.22||||||Unadjusted p-value|Paired t-Test|Unadjusted p-value||||||0.22
72527386|NCT03350724|144585378|SUPERIORITY|||||||0.882||||||Unadjusted p-value|Paired t-Test|Unadjusted p-value||||||0.882
72527387|NCT03350724|144585379|SUPERIORITY|||||||0.64||||||Unadjusted p-value|Paired t-Test|Unadjusted p-value||||||0.64
72527388|NCT03350724|144585380|SUPERIORITY|||||||0.967||||||Unadjusted p-value|Paired t-Test|Unadjusted p-value||||||0.967
72571478|NCT00117325|144671702|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.645||||0.017|TWO_SIDED|95.0|-1.17|-0.12|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for rTNSS at Day 28||-0.12|-1.17|0.017
72527389|NCT03350724|144585381|SUPERIORITY|||||||0.375||||||Unadjusted p-value|Paired t-Test|Unadjusted p-value||||||0.375
72527390|NCT02759939|144585392|SUPERIORITY||Odds Ratio (OR)|1.23||||0.8|TWO_SIDED|||||Adjusted for multiple comparisons using the Scheffe method|See below|Random effects logistic regression with a random intercept for clinic and adjustment for participant characteristics that differed across trial arms||||||0.80
72527391|NCT02759939|144585392|SUPERIORITY||Odds Ratio (OR)|1.47||||0.32|TWO_SIDED|||||Adjusted for multiple comparisons using the Scheffe method|See below|Random effects logistic regression with a random intercept for clinic and adjustment for participant characteristics that differed across trial arms||||||0.32
72527392|NCT02759939|144585392|SUPERIORITY||Odds Ratio (OR)|0.95||||0.99|TWO_SIDED|||||Adjusted for multiple comparisons using the Scheffe method|See below|Random effects logistic regression with a random intercept for clinic and adjustment for participant characteristics that differed across trial arms||||||0.99
72527393|NCT02759939|144585392|SUPERIORITY||Odds Ratio (OR)|0.8||||0.72|TWO_SIDED|||||Adjusted for multiple comparisons using the Scheffe method|See below|Random effects logistic regression with a random intercept for clinic and adjustment for participant characteristics that differed across trial arms||||||0.72
72527394|NCT00535236|144585421|OTHER||||||<|0.001||||||Statistical criterion corresponds to the lower bound of the two-sided 90% confidence interval (CI) on the GMFR in the vaccine recipients being \>1.0|Single longitudinal regression model|Adjusted for prevaccination values||||||<0.001
72527395|NCT00535236|144585421|OTHER|||||||0.003||||||Statistical criterion corresponds to the lower bound of the two-sided 90% confidence interval (CI) on the GMFR in the vaccine recipients being \>1.0|Single longitudinal regression model|Adjusted for prevaccination values||||||0.003
72527396|NCT00535236|144585421|OTHER|||||||0.017||||||Statistical criterion corresponds to the lower bound of the two-sided 90% confidence interval (CI) on the GMFR in the vaccine recipients being \>1.0|Single longitudinal regression model|Adjusted for prevaccination values||||||0.017
72527397|NCT00535236|144585422|OTHER||||||<|0.001||||||Statistical criterion corresponds to the lower bound of the two-sided 90% confidence interval (CI) on the GMFR in the vaccine recipients being \>1.0|Single longitudinal regression model|Adjustied for prevaccination values||||||<0.001
72527398|NCT00535236|144585422|OTHER|||||||0.004||||||Statistical criterion corresponds to the lower bound of the two-sided 90% confidence interval (CI) on the geometric mean fold rise (GMFR) in the vaccine recipients being \>1.0|Single longitudinal regression model|Adjusted for prevaccination values||||||0.004
72527399|NCT00535236|144585422|OTHER|||||||0.026||||||Statistical criterion corresponds to the lower bound of the two-sided 90% confidence interval (CI) on the geometric mean fold rise (GMFR) in the vaccine recipients being \>1.0|Single longitudinal regression model|Adjusted for prevaccination values||||||0.026
72527400|NCT00535236|144585423|OTHER||Difference in Percentages|12.5|||||TWO_SIDED|95.0|-21.7|35.3|||||V212 minus placebo = Difference|||35.3|-21.7|
72527401|NCT00535236|144585423|OTHER||Difference in Percentages|10.0|||||TWO_SIDED|95.0|-15.1|42.9|||||V212 minus placebo = Difference|||42.9|-15.1|
72527402|NCT00535236|144585423|OTHER||Difference in Percentages|1.8|||||TWO_SIDED|95.0|-20.4|15.7|||||V212 minus placebo = Difference|||15.7|-20.4|
72527403|NCT00535236|144585423|OTHER||Difference in Percentages|14.4|||||TWO_SIDED|95.0|-6.5|27.6|||||V212 minus placebo = Difference|||27.6|-6.5|
72527404|NCT00535236|144585423|OTHER||Difference in Percentages|3.3|||||TWO_SIDED|95.0|-18.1|17.0|||||V212 minus placebo = Difference|||17.0|-18.1|
72527405|NCT00535236|144585424|OTHER||Difference in Percentages|0.0|||>|0.999|TWO_SIDED|95.0|-31.7|16.5|||Asymptotic method||V212 minus placebo = Difference|||16.5|-31.7|>0.999
72527406|NCT00535236|144585424|OTHER||Difference in Percentages|10.0||||0.302|TWO_SIDED|95.0|-18.8|23.2|||Asymptotic method||V212 minus placebo = Difference|||23.2|-18.8|0.302
72527407|NCT00535236|144585424|OTHER||Difference in Percentages|31.6||||0.009|TWO_SIDED|95.0|9.7|46.2|||Asymptotic method||V212 minus placebo = Difference|||46.2|9.7|0.009
72527408|NCT00535236|144585424|OTHER||Difference in Percentages|22.6||||0.041|TWO_SIDED|95.0|1.3|36.6|||Asymptotic method||V212 minus placebo = Difference|||36.6|1.3|0.041
72527409|NCT00535236|144585424|OTHER||Difference in Percentages|-11.7||||0.064|TWO_SIDED|95.0|-33.2|0.6|||Asymptotic method||V212 minus placebo = Difference|||0.6|-33.2|0.064
72527410|NCT00535236|144585425|OTHER||Difference in Percentages|-5.0||||0.556|TWO_SIDED|95.0|-36.3|9.5|||Asymptotic method||V212 minus placebo = Difference|||9.5|-36.3|0.556
72527411|NCT00535236|144585425|OTHER||Difference in Percentages|2.5||||0.617|TWO_SIDED|95.0|-25.8|13.0|||Asymptotic method||V212 minus placebo = Difference|||13.0|-25.8|0.617
72527412|NCT00535236|144585425|OTHER||Difference in Percentages|3.5||||0.411|TWO_SIDED|95.0|-13.7|12.0|||Asymptotic method||V212 minus placebo = Difference|||12.0|-13.7|0.411
72527413|NCT00535236|144585425|OTHER||Difference in Percentages|4.9||||0.328|TWO_SIDED|95.0|-12.3|13.6|||Asymptotic method||V212 minus placebo = Difference|||13.6|-12.3|0.328
72527414|NCT00535236|144585425|OTHER||Difference in Percentages|0.0|||>|0.999|TWO_SIDED|95.0|-19.2|10.0|||Asymptotic method||V212 minus placebo = Difference|||10.0|-19.2|>0.999
72527415|NCT00535236|144585426|OTHER||Difference in Percentages|10.5||||0.552|TWO_SIDED|95.0|-21.3|41.8|||Asymptotic method||V212 minus placebo = Difference|||41.8|-21.3|0.552
72527416|NCT00535236|144585426|OTHER||Difference in Percentages|6.7||||0.696|TWO_SIDED|95.0|-22.5|39.4|||Asymptotic method||V212 minus placebo = Difference|||39.4|-22.5|0.696
72527417|NCT00535236|144585426|OTHER||Difference in Percentages|7.5||||0.221|TWO_SIDED|95.0|-9.8|18.0|||Asymptotic method||V212 minus placebo = Difference|||18.0|-9.8|0.221
72527418|NCT00535236|144585426|OTHER||Difference in Percentages|6.8||||0.402|TWO_SIDED|95.0|-13.7|19.1|||Asymptotic method||V212 minus placebo = Difference|||19.1|-13.7|0.402
72527419|NCT00535236|144585426|OTHER||Difference in Percentages|3.8||||0.679|TWO_SIDED|95.0|-18.5|18.2|||Asymptotic method||V212 minus placebo = Difference|||18.2|-18.5|0.679
72527420|NCT00886587|144585437|SUPERIORITY_OR_OTHER||Estimated Mean Difference|0.04||||0.9416|TWO_SIDED|95.0|-1.09|1.17||The significance threshold level was 0.05 (two-sided).|Repeated measures ANCOVA|Treatment, visit number, and treatment-visit number interaction term as factors, with baseline score and age as covariates.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.17|-1.09|0.9416
72571479|NCT00117325|144671702|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.32||||0.095|TWO_SIDED|95.0|-0.7|0.06|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM rTNSS at Day 1||0.06|-0.70|0.095
72571480|NCT00117325|144671702|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.231||||0.236|TWO_SIDED|95.0|-0.61|0.15|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM rTNSS at Day 2||0.15|-0.61|0.236
72571481|NCT00117325|144671702|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.255||||0.205|TWO_SIDED|95.0|-0.65|0.14|||ANCOVA|||Placebo versus Fluticasone Furoate 110 mcg QD for AM rTNSS at Day 3||0.14|-0.65|0.205
72571482|NCT00117325|144671702|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.343||||0.084|TWO_SIDED|95.0|-0.73|0.05|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM rTNSS at Day 4||0.05|-0.73|0.084
72571483|NCT00117325|144671702|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.146||||0.475|TWO_SIDED|95.0|-0.55|0.26|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM rTNSS at Day 5||0.26|-0.55|0.475
72571484|NCT00117325|144671702|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.296||||0.178|TWO_SIDED|95.0|-0.73|0.14|||ANCOVA|||Placebo versus Fluticasone Furoate 110 mcg QD for AM rTNSS at Day 6||0.14|-0.73|0.178
72369113|NCT00478023|144248220|SUPERIORITY_OR_OTHER_LEGACY||Least square mean difference|51.4|||<|0.0001||95.0|36.1|66.7||Adjusted. The Hochberg procedure used for multiplicity comparisons.|ANCOVA||Only pain intensity assessments collected prior to the first dose of any additional analgesic medication considered. Afterwards LOCF used.|The null hypothesis is that all CG5503 IR dose groups are equal to the placebo group based on the mean sum of pain intensity difference at 48 hours (SPID48). The alternative hypothesis is that at least one CG5503 IR dose group is different from the placebo group based on the mean SPID48.||66.7|36.1|<0.0001
72407266|NCT02346240|144323013|SUPERIORITY||Odds Ratio (OR)|56.129|||<|0.0001|TWO_SIDED|95.0|7.787|404.555||The p-value is evaluated at a 2-sided significance level for CZP 400 mg vs. PBO|Regression, Logistic|Odds ratios, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.||The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||404.555|7.787|<0.0001
72527421|NCT00886587|144585438|SUPERIORITY_OR_OTHER||Estimated Mean Difference|0.35||||0.5431|TWO_SIDED|95.0|-0.78|1.48||The significance level threshold level was 0.05 (two-sided).|Repeated measures ANCOVA|Treatment, visit number, and treatment-visit number interaction term as factors, with baseline score and age as covariates.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.48|-0.78|0.5431
72527422|NCT00886587|144585439|SUPERIORITY_OR_OTHER||Estimated Mean Difference|-0.06||||0.788|TWO_SIDED|95.0|-0.47|0.36||The significance threshold level was 0.05 (two-sided).|ANCOVA|Treatment as a factor, baseline score as covariate.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.36|-0.47|0.788
72527423|NCT00886587|144585440|SUPERIORITY_OR_OTHER||Estimated Mean Difference|0.03||||0.9508|TWO_SIDED|95.0|-0.9|0.96||The significance threshold level was 0.05 (two-sided).|Repeated measures ANCOVA|Treatment, visit number, and treatment-visit number interaction term as factors, with baseline score and age as covariates.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.96|-0.90|0.9508
72527424|NCT03099304|144585444|SUPERIORITY||Odds Ratio (OR)|13.79||||0.0057|TWO_SIDED|95.0|1.73|640.85||The exact logistic regression model includes treatment and stratification factor (age ≤30 versus \>30).|exact logistic regression|||||640.85|1.73|0.0057
72527425|NCT03099304|144585444|SUPERIORITY||Odds Ratio (OR)|10.3||||0.0243|TWO_SIDED|95.0|1.24|487.28||The exact logistic regression model includes treatment and stratification factor (age ≤30 versus \>30).|exact logistic regression|||||487.28|1.24|0.0243
72527426|NCT03099304|144585444|SUPERIORITY||Odds Ratio (OR)|28.48|||<|0.0001|TWO_SIDED|95.0|3.74|1305.2||The exact logistic regression model includes treatment and stratification factor (age ≤30 versus \>30).|exact logistic regression|||||1305.2|3.74|<0.0001
72527427|NCT03099304|144585444|SUPERIORITY||Odds Ratio (OR)|24.66||||0.0001|TWO_SIDED|95.0|3.28|1121.4||The exact logistic regression model includes treatment and stratification factor (age ≤30 versus \>30).|exact logistic regression|||||1121.4|3.28|0.0001
72527428|NCT03099304|144585445|SUPERIORITY||Odds Ratio (OR)|1.03||||0.4936|TWO_SIDED|95.0|0.05||The upper limit of the confidence interval was not estimatable because there were too few participants with a response of clear or almost clear.|The exact logistic regression model includes treatment and stratification factor (age ≤30 versus \>30).|exact logistic regression||||||0.05|0.4936
72527429|NCT03099304|144585445|SUPERIORITY||Odds Ratio (OR)|4.16||||0.114|TWO_SIDED|95.0|0.62||The upper limit of the confidence interval was not estimatable because there were too few participants with a response of clear or almost clear.|The exact logistic regression model includes treatment and stratification factor (age ≤30 versus \>30).|exact logistic regression||||||0.62|0.1140
72527430|NCT03099304|144585445|SUPERIORITY||Odds Ratio (OR)|6.1||||0.0501|TWO_SIDED|95.0|1.0||The upper limit of the confidence interval was not estimatable because there were too few participants with a response of clear or almost clear.|The exact logistic regression model includes treatment and stratification factor (age ≤30 versus \>30).|exact logistic regression||||||1.00|0.0501
72527431|NCT03099304|144585445|SUPERIORITY||Odds Ratio (OR)|3.89||||0.1257|TWO_SIDED|95.0|0.58||The upper limit of the confidence interval was not estimatable because there were too few participants with a response of clear or almost clear.|The exact logistic regression model includes treatment and stratification factor (age ≤30 versus \>30).|exact logistic regression||||||0.58|0.1257
72527432|NCT03099304|144585446|SUPERIORITY||Odds Ratio (OR)|1.19||||0.9794|TWO_SIDED|95.0|0.33|4.33|||exact logistic regression|The exact logistic regression model includes treatment and stratification factor (age ≤30 versus \>30).||||4.33|0.33|0.9794
72527433|NCT03099304|144585446|SUPERIORITY||Odds Ratio (OR)|1.69||||0.4893|TWO_SIDED|95.0|0.51|5.86|||exact logistic regression|The exact logistic regression model includes treatment and stratification factor (age ≤30 versus \>30).||||5.86|0.51|0.4893
72527434|NCT03099304|144585453|SUPERIORITY||Least squares mean (LSM) difference|-0.44|STANDARD_ERROR_OF_MEAN|0.16||0.0056|TWO_SIDED|95.0|-0.75|-0.13|||Log Rank|Treatment comparisons were performed using the log-rank test stratified by randomization stratification factor.|LSM difference = treatment minus vehicle|||-0.13|-0.75|0.0056
72527435|NCT03099304|144585453|SUPERIORITY||LSM difference|-0.4|STANDARD_ERROR_OF_MEAN|0.15||0.0095|TWO_SIDED|95.0|-0.7|-0.1|||Log Rank|Treatment comparisons were performed using the log-rank test stratified by randomization stratification factor.|LSM difference = treatment minus vehicle|||-0.10|-0.70|0.0095
72527436|NCT03099304|144585453|SUPERIORITY||LSM difference|-0.68|STANDARD_ERROR_OF_MEAN|0.16|<|0.0001|TWO_SIDED|95.0|-0.99|-0.37|||Log Rank|Treatment comparisons were performed using the log-rank test stratified by randomization stratification factor.|LSM difference = treatment minus vehicle|||-0.37|-0.99|<0.0001
72527437|NCT03099304|144585453|SUPERIORITY||LSM difference|-0.51|STANDARD_ERROR_OF_MEAN|0.15||0.0011|TWO_SIDED|95.0|-0.8|-0.21|||Log Rank|Treatment comparisons were performed using the log-rank test stratified by randomization stratification factor.|LSM difference = treatment minus vehicle|||-0.21|-0.80|0.0011
72527438|NCT03099304|144585455|SUPERIORITY||LSM difference|-36.71|STANDARD_ERROR_OF_MEAN|10.34||0.0005|TWO_SIDED|95.0|-57.15|-16.27|||Log Rank|Treatment comparisons were performed using the log-rank test stratified by randomization stratification factor.|LSM difference = treatment minus vehicle|||-16.27|-57.15|0.0005
72527439|NCT03099304|144585455|SUPERIORITY||LM difference|-35.12|STANDARD_ERROR_OF_MEAN|10.01||0.0006|TWO_SIDED|95.0|-54.91|-15.33|||Log Rank|Treatment comparisons were performed using the log-rank test stratified by randomization stratification factor.|LSM difference = treatment minus vehicle|||-15.33|-54.91|0.0006
72527440|NCT03099304|144585455|SUPERIORITY||LSM difference|-46.02|STANDARD_ERROR_OF_MEAN|10.35|<|0.0001|TWO_SIDED|95.0|-66.47|-25.57|||Log Rank|Treatment comparisons were performed using the log-rank test stratified by randomization stratification factor.|LSM difference = treatment minus vehicle|||-25.57|-66.47|<0.0001
72527441|NCT03099304|144585455|SUPERIORITY||LSM difference|-43.8|STANDARD_ERROR_OF_MEAN|9.98|<|0.0001|TWO_SIDED|95.0|-63.52|-24.07|||Log Rank|Treatment comparisons were performed using the log-rank test stratified by randomization stratification factor.|LSM difference = treatment minus vehicle|||-24.07|-63.52|<0.0001
72527442|NCT03099304|144585462|SUPERIORITY||LSM difference|-2.84|STANDARD_ERROR_OF_MEAN|1.32||0.0326|TWO_SIDED|95.0|-5.44|-0.24|||Log Rank|Treatment comparisons were performed using the log-rank test stratified by randomization stratification factor.|LSM difference = treatment minus vehicle|||-0.24|-5.44|0.0326
72527443|NCT03099304|144585462|SUPERIORITY||LSM difference|-2.74|STANDARD_ERROR_OF_MEAN|1.28||0.0333|TWO_SIDED|95.0|-5.26|-0.22|||Log Rank|Treatment comparisons were performed using the log-rank test stratified by randomization stratification factor.|LSM difference = treatment minus vehicle|||-0.22|-5.26|0.0333
72527444|NCT03099304|144585462|SUPERIORITY||LSM difference|-5.08|STANDARD_ERROR_OF_MEAN|1.31||0.0002|TWO_SIDED|95.0|-7.68|-2.48|||Log Rank|Treatment comparisons were performed using the log-rank test stratified by randomization stratification factor.|LSM difference = treatment minus vehicle|||-2.48|-7.68|0.0002
72527445|NCT03099304|144585462|SUPERIORITY||LSM difference|-4.08|STANDARD_ERROR_OF_MEAN|1.27||0.0016|TWO_SIDED|95.0|-6.59|-1.57|||Log Rank|Treatment comparisons were performed using the log-rank test stratified by randomization stratification factor.|LSM difference = treatment minus vehicle|||-1.57|-6.59|0.0016
72527446|NCT03099304|144585464|SUPERIORITY||LSM difference|-23.53|STANDARD_ERROR_OF_MEAN|6.99||0.001|TWO_SIDED|95.0|-37.35|-9.71|||Log Rank|Treatment comparisons were performed using the log-rank test stratified by randomization stratification factor.|LSM difference = treatment minus vehicle|||-9.71|-37.35|0.0010
72527447|NCT03099304|144585464|SUPERIORITY||LSM difference|-18.47|STANDARD_ERROR_OF_MEAN|6.77||0.0072|TWO_SIDED|95.0|-31.86|-5.08|||Log Rank|Treatment comparisons were performed using the log-rank test stratified by randomization stratification factor.|LSM difference = treatment minus vehicle|||-5.08|-31.86|0.0072
72527448|NCT03099304|144585464|SUPERIORITY||LSM difference|-29.81|STANDARD_ERROR_OF_MEAN|6.98|<|0.0001|TWO_SIDED|95.0|-43.61|-16.0|||Log Rank|Treatment comparisons were performed using the log-rank test stratified by randomization stratification factor.|LSM difference = treatment minus vehicle|||-16.00|-43.61|<0.0001
72527449|NCT03099304|144585464|SUPERIORITY||LSM difference|-25.56|STANDARD_ERROR_OF_MEAN|6.75||0.0002|TWO_SIDED|95.0|-38.89|-12.22|||Log Rank|Treatment comparisons were performed using the log-rank test stratified by randomization stratification factor.|LSM difference = treatment minus vehicle|||-12.22|-38.89|0.0002
72527450|NCT03099304|144585476|SUPERIORITY||Odds Ratio (OR)|1.03||||0.4936|TWO_SIDED|95.0|0.05||The upper limit of the confidence interval was not estimatable because there were too few participants with a response of clear or almost clear.||exact logistic regression|The exact logistic regression model includes treatment and stratification factor (age ≤30 versus \>30).|||||0.05|0.4936
72527451|NCT03099304|144585476|SUPERIORITY||Odds Ratio (OR)|4.16||||0.114|TWO_SIDED|95.0|0.62||The upper limit of the confidence interval was not estimatable because there were too few participants with a response of clear or almost clear.||exact logistic regression|The exact logistic regression model includes treatment and stratification factor (age ≤30 versus \>30).|||||0.62|0.1140
72527452|NCT03099304|144585476|SUPERIORITY||Odds Ratio (OR)|6.1||||0.0501|TWO_SIDED|95.0|1.0||The upper limit of the confidence interval was not estimatable because there were too few participants with a response of clear or almost clear.||exact logistic regression|The exact logistic regression model includes treatment and stratification factor (age ≤30 versus \>30).|||||1.00|0.0501
72527453|NCT03099304|144585476|SUPERIORITY||Odds Ratio (OR)|3.89||||0.1257|TWO_SIDED|95.0|0.58||The upper limit of the confidence interval was not estimatable because there were too few participants with a response of clear or almost clear.||exact logistic regression|The exact logistic regression model includes treatment and stratification factor (age ≤30 versus \>30).|||||0.58|0.1257
72407267|NCT02346240|144323013|SUPERIORITY||Odds Ratio (OR)|36.566|||=|0.0004|TWO_SIDED|95.0|5.061|264.196||The p-value is evaluated at a 2-sided significance level for CZP 200 mg vs. PBO|Regression, Logistic|Odds ratios, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.||The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||264.196|5.061|=0.0004
72407268|NCT02346240|144323014|SUPERIORITY||Estimated difference in responder rate|33.8|||||TWO_SIDED|95.0|20.68|46.98|||Regression, Logistic|Estimated responder rate, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.|Estimate and 95 % CI for difference in proportion of responders for CZP 400 mg Q2W (RS) versus Placebo Q2W (RS).|The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||46.98|20.68|
72407269|NCT02346240|144323014|SUPERIORITY||Estimated difference in responder rate|31.0|||||TWO_SIDED|95.0|18.18|43.8|||Regression, Logistic|Estimated responder rate, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.|Estimate and 95 % CI for difference in proportion of responders for CZP 200 mg Q2W (RS) versus Placebo Q2W (RS).|The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||43.80|18.18|
72407270|NCT02346240|144323014|SUPERIORITY||Odds Ratio (OR)|39.949|||<|0.0001|TWO_SIDED|95.0|8.407|189.828||The p-value is evaluated at a 2-sided significance level for CZP 400 mg vs. PBO|Regression, Logistic|Odds ratios, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.||The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||189.828|8.407|<0.0001
72407271|NCT02346240|144323014|SUPERIORITY||Odds Ratio (OR)|35.084|||<|0.0001|TWO_SIDED|95.0|7.363|167.179||The p-value is evaluated at a 2-sided significance level for CZP 200 mg vs. PBO|Regression, Logistic|Odds ratios, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.||The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||167.179|7.363|<0.0001
72407272|NCT02346240|144323015|SUPERIORITY||Estimated difference in responder rate|70.9|||||TWO_SIDED|95.0|62.15|79.59|||Regression, Logistic|Estimated responder rate, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.|Estimate and 95 % CI for difference in proportion of responders for CZP 200 mg Q2W (RS) versus Placebo Q2W (RS).|The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||79.59|62.15|
72527454|NCT04957745|144585498|OTHER||||||<|0.01||||||"Null hypothesis is that there is no difference in Percentage of Total Viewing Time that Peripheral Target is Perceived across visual confusion conditions."|ANOVA|||"Effect of visual confusion conditions (binocular, unilateral monocular, and bilateral monocular visual confusions) on Percentage of Total Viewing Time Peripheral Target is Perceived is analyzed by repeated measure (within-subject) ANOVA. The test was performed with a significance level of 0.05."||||<0.01
72527455|NCT02130635|144585543|SUPERIORITY_OR_OTHER||Adjusted Median Ratio|0.9||||0.599|TWO_SIDED|95.0|0.39|2.07||Posterior Probability the True Treatment Ratio \<1 for Day 7|Bayesian repeated measures||Comparison of IL6 concentrations at Day 7. This is the baseline corrected ratio of 100ug/placebo for day 7.|||2.07|0.39|0.599
72527456|NCT02130635|144585543|SUPERIORITY_OR_OTHER||Adjusted Median Ratio|1.07||||0.442|TWO_SIDED|95.0|0.43|2.59||Posterior Probability the True Treatment Ratio \<1 for Day 14|Bayesian repeated measures||Comparison of IL6 concentrations at Day 14. This is the baseline corrected ratio of 100ug/placebo for day 14.|||2.59|0.43|0.442
72527457|NCT02130635|144585543|SUPERIORITY_OR_OTHER||Adjusted Median Ratio|0.68||||0.823|TWO_SIDED|95.0|0.3|1.57||Posterior Probability the True Treatment Ratio \<1 for Day 7|Bayesian repeated measures||Comparison of IL6 concentrations at Day 7. This is the baseline corrected ratio of 200ug/placebo for day 7.|||1.57|0.30|0.823
72527458|NCT02130635|144585543|SUPERIORITY_OR_OTHER||Adjusted Median Ratio|0.81||||0.69|TWO_SIDED|95.0|0.33|1.97||Posterior Probability the True Treatment Ratio \<1 for Day 14|Bayesian repeated measures||Comparison of IL6 concentrations at Day 14. This is the baseline corrected ratio of 200ug/placebo for day 14.|||1.97|0.33|0.690
72527459|NCT02130635|144585543|SUPERIORITY_OR_OTHER||Adjusted Median Ratio|0.75||||0.764|TWO_SIDED|95.0|0.33|1.71||Posterior Probability the True Treatment Ratio \<1 for Day 7|Bayesian repeated measures||Comparison of IL6 concentrations at Day 7. This is the baseline corrected ratio of 500ug/placebo for day 7.|||1.71|0.33|0.764
72527460|NCT02130635|144585543|SUPERIORITY_OR_OTHER||Adjusted Median Ratio|0.64||||0.841|TWO_SIDED|95.0|0.27|1.56||Posterior Probability the True Treatment Ratio \<1 for Day 14|Bayesian repeated measures||Comparison of IL6 concentrations at Day 14. This is the baseline corrected ratio of 500ug/placebo for day 14.|||1.56|0.27|0.841
72527461|NCT02130635|144585543|SUPERIORITY_OR_OTHER||Adjusted Median Ratio|0.81||||0.702|TWO_SIDED|95.0|0.35|1.81||Posterior Probability the True Treatment Ratio \<1 for Day 7|Bayesian repeated measures||Comparison of IL8 concentrations at Day 7.This is the baseline corrected ratio of 100ug/placebo for day 7.|||1.81|0.35|0.702
72527462|NCT02130635|144585543|SUPERIORITY_OR_OTHER||Adjusted Median Ratio|0.91||||0.578|TWO_SIDED|95.0|0.33|2.47||Posterior Probability the True Treatment Ratio \<1 for Day 14|Bayesian repeated measures||Comparison of IL8 concentrations at Day 14. This is the baseline corrected ratio of 100ug/placebo for day 14.|||2.47|0.33|0.578
72527463|NCT02130635|144585543|SUPERIORITY_OR_OTHER||Adjusted Median Ratio|0.71||||0.783|TWO_SIDED|95.0|0.29|1.7||Posterior Probability the True Treatment Ratio \<1 for Day 7|Bayesian repeated measures||Comparison of IL8 concentrations at Day 7. This is the baseline corrected ratio of 200ug/placebo for day 7.|||1.70|0.29|0.783
72527464|NCT02130635|144585543|SUPERIORITY_OR_OTHER||Adjusted Median Ratio|0.64||||0.797|TWO_SIDED|95.0|0.22|1.87||Posterior Probability the True Treatment Ratio \<1 for Day 14|Bayesian repeated measures||Comparison of IL8 concentrations at Day 14. This is the baseline corrected ratio of 200ug/placebo for day 14.|||1.87|0.22|0.797
72527465|NCT02130635|144585543|SUPERIORITY_OR_OTHER||Adjusted Median Ratio|0.58||||0.919|TWO_SIDED|95.0|0.27|1.26||Posterior Probability the True Treatment Ratio \<1 for Day 7|Bayesian repeated measures||Comparison of IL8 concentrations at Day 7. This is the baseline corrected ratio of 500ug/placebo for day 7.|||1.26|0.27|0.919
72527466|NCT02130635|144585543|SUPERIORITY_OR_OTHER||Adjusted Median Ratio|0.55||||0.892|TWO_SIDED|95.0|0.21|1.43||Posterior Probability the True Treatment Ratio \<1 for Day 14|Bayesian repeated measures||Comparison of IL8 concentrations at Day 14. This is the baseline corrected ratio of 500ug/placebo for day 14.|||1.43|0.21|0.892
72527467|NCT02130635|144585543|SUPERIORITY_OR_OTHER||Adjusted Median Ratio|0.47||||0.86|TWO_SIDED|95.0|0.11|1.93||Posterior Probability the True Treatment Ratio \<1 for Day 7|Bayesian repeated measures||Comparison of TNFalpha concentrations at Day 7. This is the baseline corrected ratio of 100ug/placebo for day 7.|||1.93|0.11|0.860
72527468|NCT02130635|144585543|SUPERIORITY_OR_OTHER||Adjusted Median Ratio|1.05||||0.463|TWO_SIDED|95.0|0.38|2.86||Posterior Probability the True Treatment Ratio \<1 for Day 14|Bayesian repeated measures||Comparison of TNFalpha concentrations at Day 14. This is the baseline corrected ratio of 100ug/placebo for day 14.|||2.86|0.38|0.463
72527469|NCT02130635|144585543|SUPERIORITY_OR_OTHER||Adjusted Median Ratio|0.35||||0.932|TWO_SIDED|95.0|0.09|1.42||Posterior Probability the True Treatment Ratio \<1 for Day 7|Bayesian repeated measures||Comparison of TNFalpha concentrations at Day 7. This is the baseline corrected ratio of 200ug/placebo for day 7.|||1.42|0.09|0.932
72527470|NCT02130635|144585543|SUPERIORITY_OR_OTHER||Adjusted Median Ratio|0.43||||0.952|TWO_SIDED|95.0|0.16|1.17||Posterior Probability the True Treatment Ratio \<1 for Day 14|Bayesian repeated measures||Comparison of TNFalpha concentrations at Day 14. This is the baseline corrected ratio of 200ug/placebo for day 14.|||1.17|0.16|0.952
72527471|NCT02130635|144585543|SUPERIORITY_OR_OTHER||Adjusted Median Ratio|0.46||||0.873|TWO_SIDED|95.0|0.12|1.81||Posterior Probability the True Treatment Ratio \<1 for Day 7|Bayesian repeated measures||Comparison of TNFalpha concentrations at Day 7. This is the baseline corrected ratio of 500ug/placebo for day 7.|||1.81|0.12|0.873
72527472|NCT02130635|144585543|SUPERIORITY_OR_OTHER||Adjusted Median Ratio|0.43||||0.953|TWO_SIDED|95.0|0.16|1.16||Posterior Probability the True Treatment Ratio \<1 for Day 14|Bayesian repeated measures||Comparison of TNFalpha concentrations at Day 14. This is the baseline corrected ratio of 500ug/placebo for day 14.|||1.16|0.16|0.953
72369114|NCT00478023|144248220|SUPERIORITY_OR_OTHER_LEGACY||Least square mean difference|46.9|||<|0.0001||95.0|31.4|62.4||No multiplicity adjustment.|ANCOVA|ANCOVA with treatment and centre as fixed effects and baseline pain as a covariate.|Only pain intensity assessments collected prior to the first dose of any additional analgesic medication considered. Afterwards LOCF used.|Null hypothesis of no treatment difference.||62.4|31.4|<0.0001
72527473|NCT02130635|144585543|SUPERIORITY_OR_OTHER||Adjusted Median Ratio9|1.26||||0.281|TWO_SIDED|95.0|0.56|2.82||Posterior Probability the True Treatment Ratio \<1 for Day 7|Bayesian repeated measures||Comparison of IL6 concentrations at Day 7. This is the baseline corrected ratio of 700ug/placebo for day 7.|||2.82|0.56|0.281
72527474|NCT02130635|144585543|SUPERIORITY_OR_OTHER||Adjusted Median Ratio|1.0||||0.5|TWO_SIDED|95.0|0.42|2.35||Posterior Probability the True Treatment Ratio \<1 for Day 14|Bayesian repeated measures||Comparison of IL6 concentrations at Day 14. This is the baseline corrected ratio of 700ug/placebo for day 14.|||2.35|0.42|0.500
72527475|NCT02130635|144585543|SUPERIORITY_OR_OTHER||Adjusted Median Ratio|0.76||||0.744|TWO_SIDED|95.0|0.32|1.77||Posterior Probability the True Treatment Ratio \<1 for Day 7|Bayesian repeated measures||Comparison of IL6 concentrations at Day 7. This is the baseline corrected ratio of 1000ug/placebo for day 7.|||1.77|0.32|0.744
72527476|NCT02130635|144585543|SUPERIORITY_OR_OTHER||Adjusted Median Ratio|1.21||||0.334|TWO_SIDED|95.0|0.49|3.04||Posterior Probability the True Treatment Ratio \<1 for Day 14|Bayesian repeated measures||Comparison of IL6 concentrations at Day 14. This is the baseline corrected ratio of 1000ug/placebo for day 14.|||3.04|0.49|0.334
72527477|NCT02130635|144585543|SUPERIORITY_OR_OTHER||Adjusted Median Ratio|0.81||||0.698|TWO_SIDED|95.0|0.35|1.85||Posterior Probability the True Treatment Ratio \<1 for Day 7|Bayesian repeated measures||Comparison of IL6 concentrations at Day 7. This is the baseline corrected ratio of 2000ug/placebo for day 7.|||1.85|0.35|0.698
72369115|NCT01209325|144248221|SUPERIORITY|||||||0.112||||||Two-sided p-value|Exact poisson test|||||||0.112
72527478|NCT02130635|144585543|SUPERIORITY_OR_OTHER||Adjusted Median Ratio|1.18||||0.353|TWO_SIDED|95.0|0.48|2.88||Posterior Probability the True Treatment Ratio \<1 for Day 14|Bayesian repeated measures||Comparison of IL6 concentrations at Day 14. This is the baseline corrected ratio of 2000ug/placebo for day 14.|||2.88|0.48|0.353
72527479|NCT02130635|144585543|SUPERIORITY_OR_OTHER||Adjusted Median Ratio9|1.01||||0.489|TWO_SIDED|95.0|0.45|2.26||Posterior Probability the True Treatment Ratio \<1 for Day 7|Bayesian repeated measures||Comparison of IL8 concentrations at Day 7. This is the baseline corrected ratio of 700ug/placebo for day 7.|||2.26|0.45|0.489
72527480|NCT02130635|144585543|SUPERIORITY_OR_OTHER||Adjusted Median Ratio|0.46||||0.94|TWO_SIDED|95.0|0.17|1.23||Posterior Probability the True Treatment Ratio \<1 for Day 14|Bayesian repeated measures||Comparison of IL8 concentrations at Day 14. This is the baseline corrected ratio of 700ug/placebo for day 14.|||1.23|0.17|0.940
72527481|NCT02130635|144585543|SUPERIORITY_OR_OTHER||Adjusted Median Ratio|1.01||||0.495|TWO_SIDED|95.0|0.42|2.4||Posterior Probability the True Treatment Ratio \<1 for Day 7|Bayesian repeated measures||Comparison of IL8 concentrations at Day 7. This is the baseline corrected ratio of 1000ug/placebo for day 7.|||2.40|0.42|0.495
72527482|NCT02130635|144585543|SUPERIORITY_OR_OTHER||Adjusted Median Ratio|0.82||||0.647|TWO_SIDED|95.0|0.28|2.37||Posterior Probability the True Treatment Ratio \<1 for Day 14|Bayesian repeated measures||Comparison of IL8 concentrations at Day 14. This is the baseline corrected ratio of 1000ug/placebo for day 14.|||2.37|0.28|0.647
72527483|NCT02130635|144585543|SUPERIORITY_OR_OTHER||Adjusted Median Ratio|0.87||||0.646|TWO_SIDED|95.0|0.4|1.86||Posterior Probability the True Treatment Ratio \<1 for Day 7|Bayesian repeated measures||Comparison of IL8 concentrations at Day 7. This is the baseline corrected ratio of 2000ug/placebo for day 7.|||1.86|0.40|0.646
72527484|NCT02130635|144585543|SUPERIORITY_OR_OTHER||Adjusted Median Ratio|0.74||||0.741|TWO_SIDED|95.0|0.29|1.9||Posterior Probability the True Treatment Ratio \<1 for Day 14|Bayesian repeated measures||Comparison of IL8 concentrations at Day 14. This is the baseline corrected ratio of 2000ug/placebo for day 14.|||1.90|0.29|0.741
72527485|NCT02130635|144585543|SUPERIORITY_OR_OTHER||Adjusted Median Ratio9|2.18||||0.109|TWO_SIDED|95.0|0.62|7.95||Posterior Probability the True Treatment Ratio \<1 for Day 7|Bayesian repeated measures||Comparison of TNFalpha concentrations at Day 7. This is the baseline corrected ratio of 700ug/placebo for day 7.|||7.95|0.62|0.109
72407273|NCT02346240|144323015|SUPERIORITY||Estimated difference in responder rate|64.4|||||TWO_SIDED|95.0|55.12|73.63|||Regression, Logistic|Estimated responder rate, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.|Estimate and 95 % CI for difference in proportion of responders for CZP 200 mg Q2W (RS) versus Placebo Q2W (RS).|The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||73.63|55.12|
72407274|NCT02346240|144323015|SUPERIORITY||Odds Ratio (OR)|76.277|||<|0.0001|TWO_SIDED|95.0|17.952|324.094||The p-value is evaluated at a 2-sided significance level for CZP 400 mg vs. PBO|Regression, Logistic|Odds ratios, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.||The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||324.094|17.952|<0.0001
72527486|NCT02130635|144585543|SUPERIORITY_OR_OTHER||Adjusted Median Ratio|1.37||||0.24|TWO_SIDED|95.0|0.55|3.45||Posterior Probability the True Treatment Ratio \<1 for Day 14|Bayesian repeated measures||Comparison of TNFalpha concentrations at Day 14. This is the baseline corrected ratio of 700ug/placebo for day 14.|||3.45|0.55|0.240
72527487|NCT02130635|144585543|SUPERIORITY_OR_OTHER||Adjusted Median Ratio|1.1||||0.447|TWO_SIDED|95.0|0.27|4.44||Posterior Probability the True Treatment Ratio \<1 for Day 7|Bayesian repeated measures||Comparison of TNFalpha concentrations at Day 7. This is the baseline corrected ratio of 1000ug/placebo for day 7.|||4.44|0.27|0.447
72527488|NCT02130635|144585543|SUPERIORITY_OR_OTHER||Adjusted Median Ratio|1.03||||0.472|TWO_SIDED|95.0|0.39|2.74||Posterior Probability the True Treatment Ratio \<1 for Day 14|Bayesian repeated measures||Comparison of TNFalpha concentrations at Day 14. This is the baseline corrected ratio of 1000ug/placebo for day 14.|||2.74|0.39|0.472
72527489|NCT02130635|144585543|SUPERIORITY_OR_OTHER||Adjusted Median Ratio|0.78||||0.698|TWO_SIDED|95.0|0.21|2.9||Posterior Probability the True Treatment Ratio \<1 for Day 7|Bayesian repeated measures||Comparison of TNFalpha concentrations at Day 7. This is the baseline corrected ratio of 2000ug/placebo for day 7.|||2.90|0.21|0.698
72527490|NCT02130635|144585543|SUPERIORITY_OR_OTHER||Adjusted Median Ratio|0.53||||0.911|TWO_SIDED|95.0|0.21|1.37||Posterior Probability the True Treatment Ratio \<1 for Day 14|Bayesian repeated measures||Comparison of TNFalpha concentrations at Day 14. This is the baseline corrected ratio of 2000ug/placebo for day 14.|||1.37|0.21|0.911
72527491|NCT02608892|144585566|SUPERIORITY|Use of pain management during newborn screening was described using frequency and proportion and expressed as an absolute difference in proportions with 95% confidence interval.|Absolute difference in proportions|-7.4|||||TWO_SIDED|95.0|-26.2|11.5||||||||11.5|-26.2|
72527492|NCT02590406|144585573|SUPERIORITY_OR_OTHER_LEGACY|||||||0.005|||||||ANOVA|||We calculated our sample size using data from EPO2: PV study (Couture: simultaneous submitted manuscript), where we found a difference in the FRC of 21% between reverse Trendelenburg with non-invasive positive pressure ventilation and beach chair position without positive pressure ventilation. Assuming there would be a difference of 21% in the apnea time, with a type I error of 5% and power of 80%, a total of 17 patients by group was needed.||||0.005
72527493|NCT02590406|144585574|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||||||<0.0001
72527494|NCT02590406|144585575|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0003|||||||ANOVA|||||||0.0003
72527495|NCT02590406|144585576|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9|||||||ANOVA|||||||0.9
72527496|NCT02590406|144585577|SUPERIORITY_OR_OTHER_LEGACY|||||||0.03|||||||ANOVA|||||||0.03
72527497|NCT00957723|144585585|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Sign test|||Change from pre-op to 1 year, 2 year and 5 year||||<0.0001
72527498|NCT00957723|144585586|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Sign test|||Change from pre-op to 1, 2, and 5 year||||<0.0001
72527499|NCT00957723|144585588|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Sign test|||SF36 Physical Component Score change from preop to 1 year||||<0.0001
72527500|NCT00957723|144585588|SUPERIORITY_OR_OTHER|||||||0.0002|||||||Sign test|||SF36 Mental Component Score change from preop to 1 year||||0.0002
72527501|NCT00957723|144585588|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||SF36 Physical Component Score change from preop to 2 years||||<0.0001
72527502|NCT00957723|144585588|SUPERIORITY_OR_OTHER|||||||0.0177|||||||Sign test|||SF36 Mental Component Score change from preop to 2 years||||0.0177
72527503|NCT00957723|144585588|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||SF36 Physical Component Score change from preop to 3 year||||<0.0001
72527504|NCT00957723|144585588|SUPERIORITY_OR_OTHER|||||||0.0393|||||||Sign test|||SF36 Mental Component Score change from preop to 3 year||||0.0393
72527505|NCT00957723|144585588|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||SF36 Physical Component Score change from preop to 4 year||||<0.0001
72527506|NCT00957723|144585588|SUPERIORITY_OR_OTHER|||||||0.4905|||||||t-test, 2 sided|||SF36 Mental Component Score change from preop to 4 year||||0.4905
72527507|NCT00957723|144585588|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||SF36 Physical Component Score change from preop to 5 year||||<0.0001
72527508|NCT00957723|144585588|SUPERIORITY_OR_OTHER|||||||0.0037|||||||Sign test|||SF36 Mental Component Score change from preop to 5 year||||0.0037
72527509|NCT00957723|144585590|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Sign test|||LEAS score change from preop to 1, 2, 3, 4, and 5 years||||<0.0001
72527510|NCT00281528|144585606|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4476||95.0||||Group comparison was performed between group 260 mg/m\^2 ABI-007 every 3 weeks and group 130 mg/m\^2 ABI-007 weekly, as based on amended protocol, no type I error adjustment for multiplicity; a priori threshold for statistical significance is 0.05.|Cochran-Mantel-Haenszel|Stratified by study site||||||0.4476
72527511|NCT04396106|144585619|OTHER|||||||0.721|||||||Cochran-Mantel-Haenszel|||||||0.721
72527512|NCT01628718|144585627|NON_INFERIORITY|The NI margin for CAPS-IV scores was established a priori, based on a calculation of a reliable difference from baseline to posttreatment CAPS-IV scores from a previous trial (10 points). If the 95% confidence interval (CI) around the estimate does not contain the NI margin, we can reject the null hypothesis and accept the alternative hypothesis. .|Mean Difference (Final Values)|0.33||||0.05|TWO_SIDED|95.0|-10.1|9.44||one-tailed|Regression, Linear||Mean difference is the difference in mean CAPS-IV change scores (pre-post) between AD and CPT-C.|Null hypothesis: AD is inferior to CPT Alternative hypothesis: AD is non-inferior to CPT-C||9.44|-10.10|.05
72407275|NCT02346240|144323015|SUPERIORITY||Odds Ratio (OR)|55.413|||<|0.0001|TWO_SIDED|95.0|13.135|233.782||The p-value is evaluated at a 2-sided significance level for CZP 200 mg vs. PBO|Regression, Logistic|Odds ratios, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.||The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||233.782|13.135|<0.0001
72527513|NCT02313506|144585628|SUPERIORITY||Mean Difference (Net)|-31.1||||0.02|TWO_SIDED|95.0|-56.6|-5.7||No adjustment was made for multiple comparisons because Type II error is a greater concern than Type I error in feasibility studies.|ANCOVA|||ANCOVA was performed to evaluate the effect of the group type on the outcome measures after adjusting for blocking and baseline (T0). We assessed 3 planned contrasts of changes in outcome measures over time. Contrast 1 compared T0-T1 between the 2 groups to determine if the intervention was superior to the control.||-5.7|-56.6|0.02
72527514|NCT02313506|144585628|SUPERIORITY||Mean Difference (Net)|4.6||||0.71|TWO_SIDED|95.0|-19.6|28.9|||ANCOVA|||ANCOVA was performed to evaluate the effect of the group type on the outcome measures after adjusting for blocking and baseline (T0). We assessed 3 planned contrasts of changes in outcome measures over time. Contrast 2 compared T0-T1 in the immediate group against T1-T2 in the delayed group.||28.9|-19.6|0.71
72527515|NCT02313506|144585628|SUPERIORITY||Mean Difference (Net)|-11.0||||0.29|TWO_SIDED|95.0|-31.1|9.1|||ANCOVA|||ANCOVA was performed to evaluate the effect of the group type on the outcome measures after adjusting for blocking and baseline (T0). We assessed 3 planned contrasts of changes in outcome measures over time. Contrast 3 compared T0-T1 in the immediate group against T0-T2 in the delayed group.||9.1|-31.1|0.29
72527516|NCT01202643|144585693|SUPERIORITY_OR_OTHER|||||||0.67|TWO_SIDED||||||ANCOVA|||||||0.67
72527517|NCT01202643|144585694|SUPERIORITY_OR_OTHER|||||||0.74|||||||Chi-squared, Corrected|||Study was closed due to insufficient recruitment||||0.74
72527518|NCT01711359|144585783|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Noninferiority is concluded if the lower bound of the 95% CI for the difference in response rate is \>-12%|Newcombe-Wilson method|14.8|||||TWO_SIDED|95.0|5.5|24.1|||||Estimation Parameter: Newcombe-Wilson method without continuity correction for difference in the response rate (Baricitinib minus Methotrexate).|||24.1|5.5|
72527519|NCT02698176|144585805|OTHER||Estimation of DLT Rate|0.25|||||TWO_SIDED|80.0|0.121|0.418|||||Point estimate and 2-sided 80% Bayesian credible interval for DLT rate estimated for the total number of participants from all 3 cohorts (CRPC+NMC+TNBC) that were evaluable for DLT analysis based on a non-informative prior distribution of Beta (1,1).|||0.418|0.121|
72527520|NCT02985684|144585847|OTHER|Acceptable performance: favorably exclude PG=0.88 with 95% confidence. Expected 6-month closure success proportion = 0.98. Acceptable performance margin = 0.10. PG = 0.98 - 0.10 = 0.88.|Binomial proportion|1.0|||<|0.0001|ONE_SIDED|95.0|0.974|||A priori 1-sided alpha = 0.05. If test rejects H0, then test primary outcome 2 (clinical success) at 1-sided alpha = 0.05; otherwise testing stops with failure to reject both primary outcome null hypotheses.|Binomial test (exact)||Exact 1-sided confidence interval lower bound from Clopper-Pearson method.|"Test null hypothesis of equal or lesser proportion with 6-month closure success compared to a performance goal (PG).~H0: P ≤ 0.88 vs H1: P \> 0.88, where P is the true proportion of subjects with 6-month closure success and 0.88 is the PG derived from clinical study outcomes for devices indicated for ASD closure.~N=103 subjects provide ≥95% power to exclude PG with 95% confidence if P=0.98 under H1."|||0.974|<0.0001
72527521|NCT02985684|144585848|OTHER|Acceptable performance: favorably exclude PG=0.76 with 95% confidence. Expected 6-month clinical success proportion = 0.88. Acceptable performance margin = 0.12. PG = 0.88 - 0.12 = 0.76.|Binomial proportion|0.9|||<|0.0001|ONE_SIDED|95.0|0.843|||A priori 1-sided alpha = 0.05. If test of primary outcome 1 rejects H0, then test at 1-sided alpha = 0.05; otherwise no testing of this primary outcome and failure to reject null hypothesis.|Binomial test (exact)||Exact 1-sided confidence interval lower bound from Clopper-Pearson method.|"Test null hypothesis of equal or lesser proportion with 6-month clinical success compared to a performance goal (PG).~H0: P ≤ 0.76 vs H1: P \> 0.76, where P is the true proportion of subjects with 6-month clinical success and 0.76 is the PG derived from clinical study outcomes for devices indicated for ASD closure.~N=112 subjects provide 95% power to exclude PG with 95% confidence if P=0.88 under H1."|||0.843|<0.0001
72527522|NCT01436357|144585862|SUPERIORITY||Hazard Ratio (HR)|1.529||||0.317|TWO_SIDED|95.0|0.661|3.535|||Regression, Cox|||||3.535|0.661|0.317
72527523|NCT01436357|144585863|SUPERIORITY||Risk Difference (RD)|0.08||||0.029|TWO_SIDED|95.0|-0.01|0.16|||Fisher Exact|||||0.16|-0.01|0.029
72527524|NCT01436357|144585864|SUPERIORITY||Risk Difference (RD)|0.1||||0.015|TWO_SIDED|95.0|0.01|0.2|||Fisher Exact|||||0.20|0.01|0.015
72527525|NCT01436357|144585865|SUPERIORITY||Risk Difference (RD)|0.0||||0|TWO_SIDED||||||Fisher Exact|||||||0.00
72527526|NCT01436357|144585867|SUPERIORITY||Risk Difference (RD)|0.01||||0.499|TWO_SIDED|95.0|-0.08|0.1|||Fisher Exact|||||0.10|-0.08|0.499
72527527|NCT05281094|144585888|SUPERIORITY||Vaccine Efficacy|12.98|||||TWO_SIDED|95.0|-52.51|50.35|||||. Vaccine efficacy is demonstrated if the lower limit of the 95.0% CI is above 0%.|VE is defined 100% \[1- (λV/λC)\], where λV and λC denote the hazard rates for the HIL-214 and placebo arms respectively, obtained via a stratified Cox proportional hazards model, using Efron's method for handling ties. The model includes a term for vaccine group and was stratified by country, whereby the United States, Dominican Republic, and Puerto Rico were considered one country. The 95% confidence interval as calculated by subtracting the confidence limits of hazard ratio from 1.||50.35|-52.51|
72527528|NCT05281094|144585889|SUPERIORITY||Vaccine Efficacy|17.02|||||TWO_SIDED|95.0|-24.52|44.7|||||Vaccine efficacy is demonstrated if the lower limit of the 95.0% CI is above 0%.|VE is defined 100% \[1- (λV/λC)\], where λV and λC denote the hazard rates for the HIL-214 and placebo arms respectively, obtained via a stratified Cox proportional hazards model, using Efron's method for handling ties. The model includes a term for vaccine group and was stratified by country, whereby the United States, Dominican Republic, and Puerto Rico were considered one country. The 95% confidence interval as calculated by subtracting the confidence limits of hazard ratio from 1||44.70|-24.52|
72542581|NCT00361257|144615055|SUPERIORITY_OR_OTHER||Slope|0.064|STANDARD_ERROR_OF_MEAN|0.164||0.651|TWO_SIDED|95.0|-0.258|0.386||The p-value was not adjusted for multiple comparisons.|Regression, Linear|The model was adjusted for stratification variables, the CNS penetration score, and the baseline NPZ-8 score.|The total number used for the statistical analysis was 107 (52 in the minocycline arm and 55 in the placebo arm).|The null hypothesis was that the 24-week change of NPZ-8 in the minocycline group was the same as the one in the placebo group.||0.386|-0.258|0.651
72542582|NCT00361257|144615056|SUPERIORITY_OR_OTHER||Slope|0.091|STANDARD_ERROR_OF_MEAN|0.116||0.434|TWO_SIDED|95.0|-0.14|0.323||The p-value was not adjusted for multiple comparisons.|Regression, Linear|The model was adjusted for stratification variables, the CNS penetration score, and the baseline GDS score.||The null hypothesis was that the 24-week changes in Global Deficit Score (GDS) between the minocycline and placebo groups are the same.||0.323|-0.140|0.434
72542583|NCT00361257|144615057|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.569|STANDARD_DEVIATION|0.469||0.337|TWO_SIDED|95.0|0.625|3.936||The p-value was not adjusted for multiple comparisons.|Regression, Cumulative Logistic|The model was adjusted for the stratification variables and the CNS penetration score.||The null hypothesis is that the 24 week changes of participants' clinical status in the minocycline group were the same as the ones in the placebo group based on ICGIS.||3.936|0.625|0.337
72542584|NCT00361257|144615058|SUPERIORITY_OR_OTHER||Slope|0.502|STANDARD_ERROR_OF_MEAN|0.428||0.243|TWO_SIDED|95.0|-0.349|1.354||The p-value was not adjusted for multiple comparisons.|Regression, Linear|The model was adjusted for the stratification variables, the CNS penetration score, and the baseline cognitive gross motor function domain score.||The null hypothesis is that the 24 week change in the cognitive gross motor function domain score in the minocycline group is the same as the one in the placebo group.||1.354|-0.349|0.243
72542585|NCT00361257|144615059|SUPERIORITY_OR_OTHER||Slope|0.293|STANDARD_ERROR_OF_MEAN|0.153||0.059|TWO_SIDED|95.0|-0.011|0.596||The p-value was not adjusted for multiple comparisons.|Regression, Linear|The model was adjusted for the stratification variables, the CNS penetration score, and the baseline fine motor function domain score.||The null hypothesis was that the 24 week change in fine motor function domain score in the minocycline group was the same as the one in the placebo group.||0.596|-0.011|0.059
72542586|NCT00361257|144615060|SUPERIORITY_OR_OTHER||Slope|-0.083|STANDARD_ERROR_OF_MEAN|0.147||0.572|TWO_SIDED|95.0|-0.375|0.209||The p-value was not adjusted for multiple comparisons.|Regression, Linear|The model was adjusted for stratified variables, the baseline CNS penetration score, and the baseline psychomotor function domain score.||The null hypothesis was that the 24 change of psychomotor function domain score in the minocycline group is the same as in the placebo group.||0.209|-0.375|0.572
72542587|NCT00361257|144615061|SUPERIORITY_OR_OTHER||Slope|-0.086|STANDARD_ERROR_OF_MEAN|0.182||0.637|TWO_SIDED|95.0|-0.449|0.276||The p-value was not adjusted for multiple comparisons.|Regression, Linear|The model was adjusted for the stratification variables, the CNS penetration score, and the baseline fine motor/nonverbal function domain score.||The null hypothesis was that the 24 week change of fine motor/nonverbal function domain score in the minocycline group was the same as in the placebo group.||0.276|-0.449|0.637
72542588|NCT00361257|144615062|SUPERIORITY_OR_OTHER||Slope|-0.074|STANDARD_ERROR_OF_MEAN|0.236||0.754|TWO_SIDED|95.0|-0.544|0.396||The p-value was not adjusted for multiple comparisons.|Regression, Linear|The model was adjusted for the stratification variables, the CNS penetration score, and the baseline information processing function domain score.||The null hypothesis was that the 24 week change of information processing function domain score in the minocycline group was the same as the one in the placebo group.||0.396|-0.544|0.754
72542589|NCT00361257|144615063|SUPERIORITY_OR_OTHER||Slope|0.145|STANDARD_ERROR_OF_MEAN|0.207||0.484|TWO_SIDED|95.0|-0.266|0.558||The p-value was not adjusted for multiple comparisons.|Regression, Linear|The model was adjusted for the stratification variables, the baseline CNS penetration score, and the baseline verbal memory domain score.||The null hypothesis was that the 24 week change of verbal memory domain score in the minocycline group was the same as the one in the placebo group.||0.558|-0.266|0.484
72542590|NCT00361257|144615064|SUPERIORITY_OR_OTHER||Slope|-0.126|STANDARD_ERROR_OF_MEAN|0.172||0.467|TWO_SIDED|95.0|-0.467|0.216||The p-value was not adjusted for multiple comparisons.|Regression, Linear|The model was adjusted for the stratification variables, the baseline CNS penetration score, and the baseline frontal systems function domain score.||The null hypothesis was that the 24 week change of frontal systems function domain score in the minocycline group was the same as the one in the placebo group.||0.216|-0.467|0.467
72542591|NCT00361257|144615065|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.476|STANDARD_DEVIATION|1.048||0.234|TWO_SIDED|95.0|0.575|10.668||The p-value was not adjusted for multiple comparisons.|Regression, Linear|The model was adjusted for the CNS penetration score. The stratification variables could not be included in the model since the model fit was poor.||"The null hypothesis was that the proportion of being better at 24 weeks in minocycline group was the same as in the placebo group."||10.668|0.575|0.234
72542592|NCT00361257|144615066|SUPERIORITY_OR_OTHER||Slope|19.09|STANDARD_ERROR_OF_MEAN|33.75||0.574|TWO_SIDED|95.0|-48.26|86.44||The p-value was not adjusted for multiple comparisons.|Regression, Linear|The model was adjusted for stratification variables, the baseline CNS score, and the baseline CD4 cell count.||The null hypothesis was that the 24 week change in CD4 cell counts in the minocycline group was the same as the one in the placebo group.||86.44|-48.26|0.574
72542593|NCT00361257|144615067|SUPERIORITY_OR_OTHER||Slope|40.43|STANDARD_ERROR_OF_MEAN|59.91||0.502|TWO_SIDED|95.0|-79.12|159.97||The p-value was not adjusted for multiple comparisons.|Regression, Linear|The model was adjusted for the stratification variables, the baseline CNS penetration score, and the baseline CD8 cell counts.||The null hypothesis was that the 24 week change in CD8 cell count in the minocycline group was the same as the one in the placebo group.||159.97|-79.12|0.502
72542594|NCT00361257|144615068|SUPERIORITY_OR_OTHER|||||||0.967||95.0|||||Log Rank|||The null hypothesis was that the time to Grade 2 or higher toxicity and/or signs and symptoms in the minocycline group was the same as the one in the placebo group.||||0.967
72527529|NCT05281094|144585890|SUPERIORITY||Vaccine Efficacy|13.91|||||TWO_SIDED|95.0|-34.7|44.98|||||Vaccine efficacy is demonstrated if the lower limit of the 95.0% CI is above 0%.|VE is defined 100% \[1- (λV/λC)\], where λV and λC denote the hazard rates for the HIL-214 and placebo arms respectively, obtained via a stratified Cox proportional hazards model, using Efron's method for handling ties. The model includes a term for vaccine group and was stratified by country, whereby the United States, Dominican Republic, and Puerto Rico were considered one country. The 95% confidence interval as calculated by subtracting the confidence limits of hazard ratio from 1.||44.98|-34.70|
72527530|NCT05281094|144585891|SUPERIORITY||Vaccine Efficacy|-6.37|||||TWO_SIDED|95.0|-45.04|22.0|||||Vaccine efficacy is demonstrated if the lower limit of the 95.0% CI is above 0%.|VE is defined 100% \[1- (λV/λC)\], where λV and λC denote the hazard rates for the HIL-214 and placebo arms respectively, obtained via a stratified Cox proportional hazards model, using Efron's method for handling ties. The model includes a term for vaccine group and was stratified by country, whereby the United States, Dominican Republic, and Puerto Rico were considered one country. The 95% confidence interval as calculated by subtracting the confidence limits of hazard ratio from 1.||22.00|-45.04|
72527531|NCT00631969|144585903|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.109|||<|0.0001||95.0|-8.562|-5.6561|||ANCOVA|||Power adjustment for 3 primary efficacy variables (3 variables have to be significant in favor of Vardenafil to conclude efficacy). Statistical analysis applies to the total population.||-5.6561|-8.562|< 0.0001
72527532|NCT00631969|144585904|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-29.027|||<|0.0001||95.0|-35.519|-22.534|||ANCOVA|||Statistical analysis applies to the total population.||-22.534|-35.519|< 0.0001
72527533|NCT00631969|144585905|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-38.193|||<|0.0001||95.0|-45.021|-31.366|||ANCOVA|||Statistical analysis applies to the total population.||-31.366|-45.021|< 0.0001
72527534|NCT00631969|144585906|SUPERIORITY_OR_OTHER||Cochran-Mantel-Haenszel|34.778|||<|0.0001||95.0|||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) adjusted for age group and pooled center.||Statistical analysis applies to the total population.||||<0.0001
72527535|NCT00631969|144585907|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.503|||<|0.0001||95.0|-22.424|-10.764|||ANCOVA|||Statistical analysis applies to the total population.||-10.764|-22.424|< 0.0001
72527536|NCT00631969|144585908|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-38.167|||<|0.0001||95.0|-45.261|-31.073|||ANCOVA|||Statistical analysis applies to the total population.||-31.073|-45.261|< 0.0001
72527537|NCT00631969|144585909|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-36.555|||<|0.0001||95.0|-43.645|-29.465|||ANCOVA|||Statistical analysis applies to the total population.||-29.465|-43.645|< 0.0001
72527538|NCT00631969|144585910|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-25.193|||<|0.0001||95.0|-31.562|-18.824|||ANCOVA|||Statistical analysis applies to the total population.||-18.824|-31.562|< 0.0001
72527539|NCT00631969|144585912|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-24.703|||<|0.0001||95.0|-30.067|-19.34|||ANCOVA|||Statistical analysis applies to the total population.||-19.340|-30.067|< 0.0001
72527540|NCT00631969|144585913|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-24.496|||<|0.0001||95.0|-34.865|-24.128|||ANCOVA|||Statistical analysis applies to the total population.||-24.128|-34.865|< 0.0001
72571485|NCT00117325|144671702|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.406||||0.071|TWO_SIDED|95.0|-0.85|0.04|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM rTNSS at Day 7||0.04|-0.85|0.071
72527541|NCT00631969|144585914|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-27.775|||<|0.0001||95.0|-33.155|-22.394|||ANCOVA|||Statistical analysis applies to the total population.||-22.394|-33.155|< 0.0001
72527542|NCT00631969|144585915|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-23.326|||<|0.0001||95.0|-29.062|-17.598|||ANCOVA|||Statistical analysis applies to the total population.||-17.598|-29.062|< 0.0001
72527543|NCT00631969|144585916|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-23.384|||<|0.0001||95.0|-28.594|-18.175|||ANCOVA|||Statistical analysis applies to the total population.||-18.175|-28.594|< 0.0001
72527544|NCT00631969|144585917|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-33.076|||<|0.0001||95.0|-38.745|-27.407|||ANCOVA|||Statistical analysis applies to the total population.||-27.407|-38.745|< 0.0001
72527545|NCT00631969|144585918|SUPERIORITY_OR_OTHER||Cochran-Mantel-Haenszel|74.449|||<|0.0001||95.0|||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) adjusted for pooled centers and age group.||Statistical analysis applies to the total population.||||<0.0001
72527546|NCT00631969|144585919|NON_INFERIORITY_OR_EQUIVALENCE|This is an exploratory analysis of Vardenafil exposure in ED patients of different age categories to assess the effect of age on the drug's pharmacokinetics.|Point estimate of ratio|117.42||||||90.0|79.59|173.23||||||Point estimate and 90% confidence interval of ratio (patients aged ≥ 65 years / patients aged \< 65 years) were calculated.||173.23|79.59|
72527547|NCT00631969|144585919|NON_INFERIORITY_OR_EQUIVALENCE|This is an exploratory analysis of Vardenafil exposure in ED patients of different age categories to assess the effect of age on the drug's pharmacokinetics.||||||0.7064||95.0|||||Regression, Linear|||A linear regression line is fitted to the logarithm of AUC. Test of the hypothesis of a zero slope using the two-sided t-test at α = 0.05.||||0.7064
72527548|NCT00631969|144585920|NON_INFERIORITY_OR_EQUIVALENCE|This is an exploratory analysis of Vardenafil exposure in ED patients of different age categories to assess the effect of age on the drug's pharmacokinetics.|Point estimate of ratio|133.07||||||90.0|87.46|202.46||||||Point estimate and 90% confidence interval of ratio (patients aged ≥ 65 years / patients aged \< 65 years) were calculated.||202.46|87.46|
72527549|NCT00631969|144585920|NON_INFERIORITY_OR_EQUIVALENCE|This is an exploratory analysis of Vardenafil exposure in ED patients of different age categories to assess the effect of age on the drug's pharmacokinetics.||||||0.8749||95.0|||||Regression, Linear|||A linear regression line is fitted to the logarithm of Cmax. Test of the hypothesis of a zero slope using the two-sided t-test at α=0.05.||||0.8749
72527550|NCT00631969|144585921|NON_INFERIORITY_OR_EQUIVALENCE|This is an exploratory analysis of metabolite M-1 exposure in ED patients of different age categories to assess the effect of age on the drug's pharmacokinetics.|Point estimate of ratio|125.28||||||90.0|73.65|213.11||||||Point estimate and 90% confidence interval of ratio (patients aged ≥ 65 years/ patients aged \< 65 years) were calculated.||213.11|73.65|
72527551|NCT00631969|144585921|NON_INFERIORITY_OR_EQUIVALENCE|This is an exploratory analysis of metabolite M-1 exposure in ED patients of different age categories to assess the effect of age on the drug's pharmacokinetics.||||||0.7375||95.0|||||Regression, Linear|||A linear regression line is fitted to the logarithm of AUC. Test of the hypothesis of a zero slope using the two-sided t-test at α=0.05.||||0.7375
72527552|NCT00631969|144585922|NON_INFERIORITY_OR_EQUIVALENCE|This is an exploratory analysis of metabolite M-1 exposure in ED patients of different age categories to assess the effect of age on the drug's pharmacokinetics.|Point estimate of ratio|123.84||||||90.0|80.12|191.42||||||Point estimate and 90% confidence interval of ratio (patients aged ≥ 65 years / patients aged \< 65 years) were calculated.||191.42|80.12|
72527553|NCT00631969|144585922|NON_INFERIORITY_OR_EQUIVALENCE|This is an exploratory analysis of metabolite M-1 exposure in ED patients of different age categories to assess the effect of age on the drug's pharmacokinetics.||||||0.394||95.0|||||Regression, Linear|||A linear regression line is fitted to the logarithm of Cmax. Test of the hypothesis of a zero slope using the two-sided t-test at α = 0.05.||||0.3940
72527554|NCT05315297|144585923|SUPERIORITY|||||||0.87|||||||Wilcoxon (Mann-Whitney)|||||||0.87
72527555|NCT05315297|144585924|SUPERIORITY|||||||0.13|||||||Wilcoxon (Mann-Whitney)|||||||0.13
72527556|NCT05315297|144585925|SUPERIORITY|||||||0.78|||||||Wilcoxon (Mann-Whitney)|||||||0.78
72527557|NCT05315297|144585926|SUPERIORITY|||||||0.59|||||||Wilcoxon (Mann-Whitney)|||||||0.59
72527558|NCT05315297|144585927|SUPERIORITY|||||||0.37|||||||Wilcoxon (Mann-Whitney)|||||||0.37
72527559|NCT05315297|144585928|SUPERIORITY|||||||0.19|||||||Wilcoxon (Mann-Whitney)|||||||0.19
72527560|NCT02043704|144585975|EQUIVALENCE|The null hypothesis is that there is no difference in the pain scores between the groups.||||||0.328||||||The p-value was not adjusted for multiple comparisons.|Wilcoxon (Mann-Whitney)|There were no adjustments.||The comparison was analyzed using the Mann-Whitney U test.||||0.328
72527561|NCT01432236|144586020|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.61||||0.0001|TWO_SIDED|95.0|-0.91|-0.31||Primary analysis was two-sided and performed at the 0.05 significance level.|Mixed Models Analysis|Satterthwaite's approximation was used to estimate denominator degrees of freedom.||Analysis was done using a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within-participant error as random factors.||-0.31|-0.91|0.0001
72527562|NCT01432236|144586022|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.6|||<|0.0001|TWO_SIDED|95.0|-9.33|-3.87||Analysis was conducted using a two-sided test with α=0.05. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.|Mixed Models Analysis|||Statistical analysis presented above is for the FIQ total score. Analysis was performed using a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within-participant error as random factors.||-3.87|-9.33|<0.0001
72527563|NCT01432236|144586022|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.42||||0.0078|TWO_SIDED|95.0|-0.74|-0.11||Analysis was conducted using a two-sided test with α=0.05. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.|Mixed Models Analysis|||Statistical analysis presented above is for parameter 'physical impairment'. Analysis was performed using a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within-participant error as random factors.||-0.11|-0.74|0.0078
72527564|NCT01432236|144586022|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.85||||0.0014|TWO_SIDED|95.0|-1.36|-0.33||Analysis was conducted using a two-sided test with α=0.05. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.|Mixed Models Analysis|||Statistical analysis presented above is for the parameter 'feel good'. Analysis was performed using a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within-participant error as random factors.||-0.33|-1.36|0.0014
72527565|NCT01432236|144586022|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.59||||0.005|TWO_SIDED|95.0|-1.01|-0.18||Analysis was conducted using a two-sided test with α=0.05. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.|Mixed Models Analysis|||Statistical analysis presented above for parameter 'work missed'. Analysis was performed using a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within-participant error as random factors.||-0.18|-1.01|0.0050
72527566|NCT01432236|144586022|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.75||||0.0002|TWO_SIDED|95.0|-1.14|-0.36||Analysis was conducted using a two-sided test with α=0.05. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.|Mixed Models Analysis|||Statistical analysis presented above is for the parameter 'do work'. Analysis was performed using a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within-participant error as random factors.||-0.36|-1.14|0.0002
72527567|NCT01432236|144586022|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.64||||0.0006|TWO_SIDED|95.0|-1.0|-0.28||Analysis was conducted using a two-sided test with α=0.05. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.|Mixed Models Analysis|||Statistical analysis presented above is for the parameter 'pain'. Analysis was performed using a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within-participant error as random factors.||-0.28|-1.00|0.0006
72571486|NCT00117325|144671702|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.111||||0.621|TWO_SIDED|95.0|-0.55|0.33|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM rTNSS at Day 8||0.33|-0.55|0.621
72571487|NCT00117325|144671702|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.206||||0.372|TWO_SIDED|95.0|-0.66|0.25|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM rTNSS at Day 9||0.25|-0.66|0.372
72571488|NCT00117325|144671702|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.452||||0.046|TWO_SIDED|95.0|-0.9|-0.01|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM rTNSS at Day 10||-0.01|-0.90|0.046
72571489|NCT00117325|144671702|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.302||||0.183|TWO_SIDED|95.0|-0.75|0.14|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM rTNSS at Day 11||0.14|-0.75|0.183
72571490|NCT00117325|144671702|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.226||||0.32|TWO_SIDED|95.0|-0.67|0.22|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM rTNSS at Day 12||0.22|-0.67|0.320
72571491|NCT00117325|144671702|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.188||||0.431|TWO_SIDED|95.0|-0.66|0.28|||ANCOVA|||Placebo versus Fluticasone Furoate 110 mcg QD for AM rTNSS at Day 13||0.28|-0.66|0.431
72571492|NCT00117325|144671702|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.299||||0.191|TWO_SIDED|95.0|-0.75|0.15|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM rTNSS at Day 14||0.15|-0.75|0.191
72571493|NCT00117325|144671702|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.475||||0.043|TWO_SIDED|95.0|-0.94|-0.02|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM rTNSS at Day 15||-0.02|-0.94|0.043
72571494|NCT00117325|144671702|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.619||||0.009|TWO_SIDED|95.0|-1.08|-0.16|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM rTNSS at Day 16||-0.16|-1.08|0.009
72571495|NCT00117325|144671702|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.495||||0.04|TWO_SIDED|95.0|-0.97|-0.02|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM rTNSS at Day 17||-0.02|-0.97|0.040
72571496|NCT00117325|144671702|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.262||||0.249|TWO_SIDED|95.0|-0.71|0.18|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM rTNSS at Day 18||0.18|-0.71|0.249
72571497|NCT00117325|144671702|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.536||||0.023|TWO_SIDED|95.0|-1.0|-0.07|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM rTNSS at Day 19||-0.07|-1.00|0.023
72571498|NCT00117325|144671702|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.24||||0.321|TWO_SIDED|95.0|-0.71|0.23|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM rTNSS at Day 20||0.23|-0.71|0.321
72571499|NCT00117325|144671702|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.568||||0.019|TWO_SIDED|95.0|-1.04|-0.09|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM rTNSS at Day 21||-0.09|-1.04|0.019
72571500|NCT00117325|144671702|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.419||||0.092|TWO_SIDED|95.0|-0.91|0.07|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM rTNSS at Day 22||0.07|-0.91|0.092
72571501|NCT00117325|144671702|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.206||||0.404|TWO_SIDED|95.0|-0.69|0.28|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM rTNSS at Day 23||0.28|-0.69|0.404
72571502|NCT00117325|144671702|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.546||||0.027|TWO_SIDED|95.0|-1.03|-0.06|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM rTNSS at Day 24||-0.06|-1.03|0.027
72571503|NCT00117325|144671702|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.227||||0.357|TWO_SIDED|95.0|-0.71|0.26|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM rTNSS at Day 25||0.26|-0.71|0.357
72571504|NCT00117325|144671702|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.403||||0.114|TWO_SIDED|95.0|-0.9|0.1|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM rTNSS at Day 26||0.10|-0.90|0.114
72571505|NCT00117325|144671702|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.307||||0.228|TWO_SIDED|95.0|-0.81|0.19|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM rTNSS at Day 27||0.19|-0.81|0.228
72571506|NCT00117325|144671702|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.725||||0.012|TWO_SIDED|95.0|-1.29|-0.16|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM rTNSS at Day 28||-0.16|-1.29|0.012
72571507|NCT00117325|144671702|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.093||||0.643|TWO_SIDED|95.0|-0.49|0.3|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for PM rTNSS at Day 1||0.30|-0.49|0.643
72571508|NCT00117325|144671702|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.279||||0.15|TWO_SIDED|95.0|-0.66|0.1|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for PM rTNSS at Day 2||0.10|-0.66|0.150
72571509|NCT00117325|144671702|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.291||||0.162|TWO_SIDED|95.0|-0.7|0.12|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for PM rTNSS at Day 3||0.12|-0.70|0.162
72571510|NCT00117325|144671702|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.244||||0.242|TWO_SIDED|95.0|-0.65|0.17|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for PM rTNSS at Day 4||0.17|-0.65|0.242
72571511|NCT00117325|144671702|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.223||||0.278|TWO_SIDED|95.0|-0.63|0.18|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for PM rTNSS at Day 5||0.18|-0.63|0.278
72571512|NCT00117325|144671702|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.282||||0.2|TWO_SIDED|95.0|-0.71|0.15|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for PM rTNSS at Day 6||0.15|-0.71|0.200
72571513|NCT00117325|144671702|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.164||||0.456|TWO_SIDED|95.0|-0.6|0.27|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for PM rTNSS at Day 7||0.27|-0.60|0.456
72571514|NCT00117325|144671702|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.385||||0.076|TWO_SIDED|95.0|-0.81|0.04|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for PM rTNSS at Day 8||0.04|-0.81|0.076
72407276|NCT02346240|144323016|SUPERIORITY||Estimated difference in responder rate|55.0|||||TWO_SIDED|95.0|45.59|64.35|||Regression, Logistic|Estimated responder rate, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.|Estimate and 95 % CI for difference in proportion of responders for CZP 400 mg Q2W (RS) versus Placebo Q2W (RS).|The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||64.35|45.59|
72571515|NCT00117325|144671702|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.396||||0.084|TWO_SIDED|95.0|-0.85|0.05|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for PM rTNSS at Day 9||0.05|-0.85|0.084
72571516|NCT00117325|144671702|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.481||||0.04|TWO_SIDED|95.0|-0.94|-0.02|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for PM rTNSS at Day 10||-0.02|-0.94|0.040
72571517|NCT00117325|144671702|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.405||||0.09|TWO_SIDED|95.0|-0.87|0.06|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for PM rTNSS at Day 11||0.06|-0.87|0.090
72571518|NCT00117325|144671702|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.432||||0.06|TWO_SIDED|95.0|-0.88|0.02|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for PM rTNSS at Day 12||0.02|-0.88|0.060
72571519|NCT00117325|144671702|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.277||||0.252|TWO_SIDED|95.0|-0.75|0.2|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for PM rTNSS at Day 13||0.20|-0.75|0.252
72571520|NCT00117325|144671702|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.3||||0.229|TWO_SIDED|95.0|-0.79|0.19|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for PM rTNSS at Day 14||0.19|-0.79|0.229
72571521|NCT00117325|144671702|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.373||||0.109|TWO_SIDED|95.0|-0.83|0.08|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for PM rTNSS at Day 15||0.08|-0.83|0.109
72571522|NCT00117325|144671702|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.484|||||TWO_SIDED|95.0|-0.96|-0.01|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for PM rTNSS at Day 16||-0.01|-0.96|
72571523|NCT00117325|144671702|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.7||||0.003|TWO_SIDED|95.0|-1.17|-0.23|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for PM rTNSS at Day 17||-0.23|-1.17|0.003
72571524|NCT00117325|144671702|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.326||||0.182|TWO_SIDED|95.0|-0.81|0.15|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for PM rTNSS at Day 18||0.15|-0.81|0.182
72571525|NCT00117325|144671702|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.299||||0.194|TWO_SIDED|95.0|-0.75|0.15|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for PM rTNSS at Day 19||0.15|-0.75|0.194
72571526|NCT00117325|144671702|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.348||||0.129|TWO_SIDED|95.0|-0.8|0.1|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for PM rTNSS at Day 20||0.10|-0.80|0.129
72407277|NCT02346240|144323016|SUPERIORITY||Estimated difference in responder rate|44.9|||||TWO_SIDED|95.0|35.39|54.49|||Regression, Logistic|Estimated responder rate, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.|Estimate and 95 % CI for difference in proportion of responders for CZP 200 mg Q2W (RS) versus Placebo Q2W (RS).|The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||54.49|35.39|
72407278|NCT02346240|144323016|SUPERIORITY||Odds Ratio (OR)|40.717|||<|0.0001|TWO_SIDED|95.0|9.741|170.198||The p-value is evaluated at a 2-sided significance level for CZP 400 mg vs. PBO|Regression, Logistic|Odds ratios, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.||The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||170.198|9.741|<0.0001
72407279|NCT02346240|144323016|SUPERIORITY||Odds Ratio (OR)|27.165|||<|0.0001|TWO_SIDED|95.0|6.504|113.453||The p-value is evaluated at a 2-sided significance level for CZP 200 mg vs. PBO|Regression, Logistic|Odds ratios, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure||The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||113.453|6.504|<0.0001
72527568|NCT01432236|144586022|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.44||||0.0315|TWO_SIDED|95.0|-0.85|-0.04||Analysis was conducted using a two-sided test with α=0.05. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.|Mixed Models Analysis|||Statistical analysis presented above is for the parameter 'fatigue'. Analysis was performed using a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within-participant error as random factors.||-0.04|-0.85|0.0315
72527569|NCT01432236|144586022|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.76||||0.0003|TWO_SIDED|95.0|-1.17|-0.35||Analysis was conducted using a two-sided test with α=0.05. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.|Mixed Models Analysis|||Statistical analysis presented above is for the parameter 'rested'. Analysis was performed using a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within-participant error as random factors.||-0.35|-1.17|0.0003
72527570|NCT01432236|144586022|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.71||||0.0007|TWO_SIDED|95.0|-1.11|-0.31||Analysis was conducted using a two-sided test with α=0.05. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.|Mixed Models Analysis|||Statistical analysis presented above is for the parameter 'stiffness'. Analysis was performed using a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within-participant error as random factors.||-0.31|-1.11|0.0007
72527571|NCT01432236|144586022|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.55||||0.0048|TWO_SIDED|95.0|-0.93|-0.17||Analysis was conducted using a two-sided test with α=0.05. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.|Mixed Models Analysis|||Statistical analysis presented above is for the parameter 'anxiety'. Analysis was performed using a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within-participant error as random factors.||-0.17|-0.93|0.0048
72527572|NCT01432236|144586022|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.92|||<|0.0001|TWO_SIDED|95.0|-1.32|-0.53||Analysis was conducted using a two-sided test with α=0.05. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.|Mixed Models Analysis|||Statistical analysis presented above is for the parameter 'depression'. Analysis was performed using a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within-participant error as random factors.||-0.53|-1.32|<0.0001
72527573|NCT01432236|144586023|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0637|TWO_SIDED|||||This analysis was conducted using a two-sided test with α=0.05. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.|Cochran-Mantel-Haenszel|||The PGIC variable was analyzed using Cochran Mantel-Haenszel (CMH) test with modified ridit transformation.||||0.0637
72527574|NCT01432236|144586024|SUPERIORITY_OR_OTHER_LEGACY|||||||0.116|TWO_SIDED|||||This analysis was conducted using a two-sided test with α=0.05. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.|Cochran-Mantel-Haenszel|||The PGIC variable was analyzed using CMH test with modified ridit transformation.||||0.1160
72527575|NCT01432236|144586025|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0007|TWO_SIDED|||||This secondary analyses was conducted using a two-sided test with α=0.05. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.|Regression, Logistic|||Statistical analysis presented above is for 30% responders. Analysis was conducted using a logistic regression model using sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors. Logit link transformation was used for the model.||||0.0007
72527576|NCT01432236|144586025|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0205|TWO_SIDED|||||This secondary analyses was conducted using a two-sided test with α=0.05. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.|Regression, Logistic|||Statistical analysis presented above is for 50% responders. Analysis was conducted using a logistic regression model using sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors. Logit link transformation was used for the model.||||0.0205
72527577|NCT01432236|144586026|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.57|||<|0.0001|TWO_SIDED|95.0|0.31|0.84||This was done using a two-sided test with α=0.05. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.|Mixed Models Analysis|||Analyzed using a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within-subject error as random factors.||0.84|0.31|<0.0001
72571527|NCT00117325|144671702|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.292||||0.232|TWO_SIDED|95.0|-0.77|0.19|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for PM rTNSS at Day 21||0.19|-0.77|0.232
72527578|NCT01432236|144586027|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-7.81||||0.0018|TWO_SIDED|95.0|-12.66|-2.96||This was done using a two-sided test with α=0.05. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.|Mixed Models Analysis|||Analyzed using a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within-participant error as random factors.||-2.96|-12.66|0.0018
72527579|NCT01432236|144586028|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.8||||0.0117|TWO_SIDED|95.0|-10.29|-1.31||This was done using a two-sided test with α=0.05. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.|Mixed Models Analysis|||Analyzed using a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within-participant error as random factors||-1.31|-10.29|0.0117
72527580|NCT01432236|144586029|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|8.35||||0.0511|TWO_SIDED|95.0|-0.04|16.74||This was done using a two-sided test with α=0.05. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.|Mixed Models Analysis|||Analyzed using a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within-participant error as random factors.||16.74|-0.04|0.0511
72527581|NCT01432236|144586030|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.13||||0.1139|TWO_SIDED|95.0|-0.29|0.03||This was done using a two-sided test with α=0.05. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.|Mixed Models Analysis|||Analyzed using a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within-participant error as random factors. Analyzed as a count variable using a generalized linear model assuming a Poisson distribution and utilizing a log link transformation.||0.03|-0.29|0.1139
72527582|NCT01432236|144586032|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.95|||<|0.0001|TWO_SIDED|95.0|-1.4|-0.5||Two-sided test with α=0.05 was used. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.|Mixed Models Analysis|||Analysis presented in the above table is for HADS-A (anxiety). Analyzed using a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within-participant error as random factors.||-0.50|-1.40|<0.0001
72527583|NCT01432236|144586032|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.88||||0.0005|TWO_SIDED|95.0|-1.37|-0.39||Two-sided test with α=0.05 was used. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.|Mixed Models Analysis|||Analysis presented in the above table is for HADS-D (depression). Analyzed using a linear mixed effects model including sequence, period, and treatment as fixed factors and subject within sequence and within-subject error as random factors.||-0.39|-1.37|0.0005
72527584|NCT01432236|144586034|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.02||||0.3854|TWO_SIDED|95.0|-0.02|0.06||Two-sided test with α=0.05 was used. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.|Mixed Models Analysis|||Analyzed using a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within-participant error as random factors.||0.06|-0.02|0.3854
72571528|NCT00117325|144671702|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.499||||0.042|TWO_SIDED|95.0|-0.98|-0.02|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for PM rTNSS at Day 22||-0.02|-0.98|0.042
72571529|NCT00117325|144671702|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.356||||0.15|TWO_SIDED|95.0|-0.84|0.13|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for PM rTNSS at Day 23||0.13|-0.84|0.150
72571530|NCT00117325|144671702|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.398||||0.09|TWO_SIDED|95.0|-0.86|0.06|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for PM rTNSS at Day 24||0.06|-0.86|0.090
72571531|NCT00117325|144671702|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.028||||0.909|TWO_SIDED|95.0|-0.52|0.46|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for PM rTNSS at Day 25||0.46|-0.52|0.909
72571532|NCT00117325|144671702|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.233||||0.354|TWO_SIDED|95.0|-0.73|0.26|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for PM rTNSS at Day 26||0.26|-0.73|0.354
72369116|NCT01209325|144248221|SUPERIORITY|||||||0.447||||||One-sided test|Exact Poisson calculation|||This study's Naive to HPV 6 group was compared to the per-protocol Merck 020 historical placebo group naive to HPV 6 (NCT00090285), 0.0 events per 100 person years (PY) versus 3.4 events per 100 PY, respectively.||||0.447
72369117|NCT01209325|144248222|SUPERIORITY|||||||0.224||||||Two-sided p-value.|Exact poisson test|||||||0.224
72369118|NCT01209325|144248222|SUPERIORITY|One-sided p-value.||||||0.361|||||||Exact Poisson calculation|||This study's Naive to HPV 11 group was compared to the per-protocol Merck 020 historical placebo group naive to HPV 11 (NCT00090285), 0.0 events per 100 person years (PY) versus 2.0 events per 100 PY, respectively.||||0.361
72369119|NCT01209325|144248223|SUPERIORITY|||||||0.079||||||Two-sided p-value.|Exact poisson test|||||||0.079
72369120|NCT01209325|144248223|SUPERIORITY|||||||0.35||||||One-sided p-value.|Exact Poisson calculation|||This study's Naive to HPV 16 group was compared to the per-protocol Merck 020 historical placebo group naive to HPV 16 (NCT00090285), 0.0 events per 100 person years (PY) versus 1.8 events per 100 PY, respectively.||||0.350
72369121|NCT01209325|144248224|SUPERIORITY|||||||0.162|||||||Exact poisson test|||||||0.162
72369122|NCT01209325|144248224|SUPERIORITY|||||||0.49||||||One-sided p-value|Exact Poisson calculation|||This study's Naive to HPV 18 group was compared to the Merck 020 per-protocol historical placebo group naive to HPV 18 (NCT00090285), 0.0 events per 100 person years (PY) versus 1.0 events per 100 PY, respectively.||||0.490
72369123|NCT01209325|144248225|SUPERIORITY|||||||0.671||||||Two-sided p-value is comparing naive and prior exposure groups for HPV 6.|Exact Poisson calculation|||||||0.671
72527585|NCT01432236|144586036|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.55||||0.0085|TWO_SIDED|95.0|0.14|0.97||Two-sided test with α=0.05 was used. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.|Mixed Models Analysis|||Analyzed using a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within-participant error as random factors.||0.97|0.14|0.0085
72527586|NCT04607291|144586071|OTHER|A logistic regression model was used to identify factors associated with screening.|||||||||||||||||"A logistic regression model was used to identify factors associated with screening. A stepwise selection procedure (alpha entry and alpha exit = 0.15) was used to determine what factors were included in the model. Overall performance is assessed using the AUC.~Factors included in the model: sex, stool test recommended by physician, know where to get stool test, fear of colonoscopy index score, ABR - afraid score, and knowledge that colonoscopy can reduce worry.~AUC: 0.71"|||
72571533|NCT00117325|144671702|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.29||||0.245|TWO_SIDED|95.0|-0.78|0.2|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for PM rTNSS at Day 27||0.20|-0.78|0.245
72369124|NCT01209325|144248225|SUPERIORITY|||||||0.312||||||One-sided p-value.|Exact Poisson calculation|||This study's Naive to HPV 6 group was compared to the per-protocol Merck 020 historical placebo group naive to HPV 6 (NCT00090285), 1.8 events per 100 person years (PY) versus 4.5 events per 100 PY, respectively.||||0.312
72369125|NCT01209325|144248226|SUPERIORITY||||||>|0.999||||||Two-sided p-value.|Exact Poisson calculation|||||||>0.999
72369126|NCT01209325|144248226|SUPERIORITY|||||||0.209||||||One-sided p-value.|Exact Poisson calculation|||This study's Naive to HPV 11 group was compared to the per-protocol Merck 020 historical placebo group naive to HPV 11 (NCT00090285), 0.0 events per 100 person years (PY) versus 1.7 events per 100 PY, respectively.||||0.209
72369127|NCT01209325|144248227|SUPERIORITY|||||||0.386||||||Two-sided p-value.|Exact Poisson calculation|||||||0.386
72369128|NCT01209325|144248227|SUPERIORITY|||||||0.305||||||One-sided test|Exact Poisson calculation|||This study's Naive to HPV 16 group was compared to the per-protocol Merck 020 historical placebo group naive to HPV 16 (NCT00090285), 2.9 events per 100 person years (PY) versus 4.9 events per 100 PY, respectively.||||0.305
72369129|NCT01209325|144248228|SUPERIORITY|||||||0.622||||||Two-sided p-value.|Exact Poisson calculation|||||||0.622
72369130|NCT01209325|144248228|SUPERIORITY|||||||0.15||||||One-sided p-value.|Exact Poisson calculation|||This study's Naive to HPV 18 group was compared to the per-protocol Merck 020 historical placebo group naive to HPV 18 (NCT00090285), 0.7 events per 100 person years (PY) versus 2.7 events per 100 PY, respectively.||||0.150
72369131|NCT01209325|144248229|SUPERIORITY|||||||0.064||||||Two-sided p-value.|Exact Poisson calculation|||||||0.064
72369132|NCT01209325|144248230|SUPERIORITY|||||||0.745||||||Two-sided test.|Exact Poisson calculation|||||||0.745
72369133|NCT01209325|144248231|SUPERIORITY|||||||0.014|||||||Exact Poisson calculation|||||||0.014
72369134|NCT01209325|144248232|SUPERIORITY|||||||0.166||||||Two-sided p-value.|Exact Poisson calculation|||||||0.166
72369135|NCT01209325|144248233|SUPERIORITY|||||||0.789||||||Two-sided p-value.|Exact Poisson calculation|||||||0.789
72369136|NCT01209325|144248234|SUPERIORITY|||||||0.809||||||Two-sided p-value.|0.809|||||||0.809
72369137|NCT01209325|144248235|SUPERIORITY|||||||0.422||||||Two-sided p-value.|Exact Poisson calculation|||||||0.422
72369138|NCT01209325|144248236|SUPERIORITY|||||||0.423||||||Two-sided p-value.|Exact Poisson calculation|||||||0.423
72369139|NCT05340478|144248261|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<.001
72369140|NCT00092443|144248270|SUPERIORITY_OR_OTHER||Efficacy = 1-Relative Risk|72.5|||<|0.001||95.0|50.6|85.6|||Exact Binomial Test||Efficacy = 1-RR, expressed as a percentage; the RR is the incidence in the vaccine group / the incidence in the placebo group.|||85.6|50.6|<0.001
72369141|NCT00092443|144248271|SUPERIORITY_OR_OTHER||Percent of Participants|56.7||||||95.0|44.0|66.8||||||||66.8|44.0|
72369142|NCT00092443|144248271|SUPERIORITY_OR_OTHER||Percent of Participants|2.7||||||95.0|0.3|9.5||||||||9.5|0.3|
72369143|NCT00092443|144248271|SUPERIORITY_OR_OTHER||Percent of Participants|14.5||||||95.0|6.9|25.8||||||||25.8|6.9|
72369144|NCT00092443|144248271|SUPERIORITY_OR_OTHER||Percent of Participants|0.0||||||95.0|0.0|5.1||||||||5.1|0.0|
72369145|NCT00092443|144248271|SUPERIORITY_OR_OTHER||Percent of Participants|9.0||||||95.0|3.4|18.5||||||||18.5|3.4|
72369146|NCT00092443|144248271|SUPERIORITY_OR_OTHER||Percent of Participants|0.0||||||95.0|0.0|4.8||||||||4.8|0.0|
72369147|NCT00092443|144248271|SUPERIORITY_OR_OTHER||Percent of Participants|39.7||||||95.0|27.6|52.8||||||||52.8|27.6|
72369148|NCT00092443|144248271|SUPERIORITY_OR_OTHER||Percent of Participants|1.4||||||95.0|0.0|7.7||||||||7.7|0.0|
72369149|NCT00092443|144248271|SUPERIORITY_OR_OTHER||Percent of Participants|24.6||||||95.0|14.5|37.3||||||||37.3|14.5|
72369150|NCT00092443|144248271|SUPERIORITY_OR_OTHER||Percent of Participants|2.9||||||95.0|0.4|10.1||||||||10.1|0.4|
72369151|NCT04717336|144248300|SUPERIORITY||Mean of Paired Differences|0.002||||0.98|TWO_SIDED|95.0|-0.22|0.23|||Paired T-Test|A paired t-test was applied across both periods because this is a cross-over study where each participant serves at their own control.||The aim of this analysis is to test whether there is a statistically significant difference in Pulse Wave Velocity when participants are on sodium chloride vs. placebo, regardless of period.||0.23|-0.22|0.98
72369152|NCT03523988|144248308|SUPERIORITY|||||||0.04||||||P-value for pain scores among the three comparison groups with jaw at rest.|ANOVA|||||||0.04
72369153|NCT03523988|144248308|SUPERIORITY|||||||0.63||||||P-value for pain scores among the three comparison groups while lightly biting.|ANOVA|||||||0.63
72369154|NCT03523988|144248308|SUPERIORITY|||||||0.41||||||P-value for pain scores among the three comparison groups while chewing paraffin wax.|ANOVA|||||||0.41
72369155|NCT03523988|144248309|SUPERIORITY|||||||0.65||||||P-value for pain scores among the three comparison groups with jaw at rest.|ANOVA|||||||0.65
72369156|NCT03523988|144248309|SUPERIORITY|||||||0.82||||||P-value for pain scores among the three comparison groups while lightly biting.|ANOVA|||||||0.82
72369157|NCT03523988|144248309|SUPERIORITY|||||||0.69||||||P-value for pain scores among the three comparison groups while chewing paraffin wax.|ANOVA|||||||0.69
72369158|NCT03523988|144248310|SUPERIORITY|||||||0.53||||||P-value for pain scores among the three comparison groups with jaw at rest.|ANOVA|||||||0.53
72407280|NCT02346240|144323017|SUPERIORITY||Estimated difference in responder rate|48.8|||||TWO_SIDED|95.0|34.22|63.41|||Regression, Logistic|Estimated responder rate, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.|Estimate and 95 % CI for difference in proportion of responders for CZP 400 mg Q2W (RS) versus Placebo Q2W (RS).|The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||63.41|34.22|
72407281|NCT02346240|144323017|SUPERIORITY||Estimated difference in responder rate|39.5|||||TWO_SIDED|95.0|25.58|53.38|||Regression, Logistic|Estimated responder rate, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.|Estimate and 95 % CI for difference in proportion of responders for CZP 200 mg Q2W (RS) versus Placebo Q2W (RS).|The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||53.38|25.58|
72407282|NCT02346240|144323017|SUPERIORITY||Odds Ratio (OR)|72.278|||<|0.0001|TWO_SIDED|95.0|14.65|356.602||The p-value is evaluated at a 2-sided significance level for CZP 400 mg vs. PBO|Regression, Logistic|Odds ratios, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.||The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||356.602|14.650|<0.0001
72527587|NCT04607291|144586072|OTHER|A logistic regression model was used to identify characteristics associated with high intent of getting a Fit test.||||||||||||||||Evaluating factors associated with high intent of getting a Fit test.|"A logistic regression model was used to identify factors associated with high intent of getting a fit test. A stepwise selection procedure (alpha entry and alpha exit = 0.15) was used to determine what factors were included in the model. Overall performance is assessed using the AUC.~Factors included in the model: sex, race, stool test or colonoscopy recommended by physician, know where to get stool test, CBPR score, and barriers to screening score.~AUC: 0.80"|||
72527588|NCT05466240|144586073|EQUIVALENCE|For each post-baseline collection time point, treatment difference and p-value comparing the mean change in viral load from baseline between treatment arms from an analysis of covariance model with covariate baseline viral load.|||||<|0.95|||||||ANCOVA|||||||<0.95
72527589|NCT01749930|144586091|NON_INFERIORITY|The 2 treatments were compared for each time point by visit. LS mean of each treatment group, the difference in the LS mean, and the 2-sided 95% CI for the difference were obtained. Noninferiority could be claimed if the upper limit of the CIs \<1.5 mmHg at all time points of each visit and \<1.00 mmHg for at least 5 out of the 9 time points. If noninferiority was determined, superiority at each time point could be claimed if the upper limit of the 95% CI\<0 mmHg at all time points of each visit.||||||0.216||||||The ANCOVA results for the comparison of LS means of mean IOP between treatment groups demonstrated noninferiority of BOL-303259-X to timolol. Superiority of BOL-303259-X to timolol was demonstrated at 8 of 9 time points (exception at 8 am Week 2).|ANCOVA|||||||0.216
72527590|NCT01749930|144586092|OTHER|||||||0.084|||||||Chi-squared|||||||0.084
72527591|NCT01749930|144586093|OTHER|||||||0.007|||||||Chi-squared|||||||0.007
72527592|NCT01749930|144586094|OTHER||||||||||||||||||No statistical analysis was performed on these proportions|||
72527593|NCT04735432|144586100|NON_INFERIORITY|This was a phase 3, multicenter, randomized, open-label, parallel-group, 12-week study to evaluate the noninferiority of the pharmacodynamic effect of efgartigimod PH20 SC 1000 mg compared with efgartigimod IV 10 mg/kg in patients with generalized myasthenia gravis.|LS mean difference|-4.2|STANDARD_ERROR_OF_MEAN|1.782|<|0.0001|TWO_SIDED|95.0|-7.73|-0.66|||ANCOVA|||The primary endpoint was analyzed using an ANCOVA model with treatment as a factor and total IgG levels at baseline as a covariate. The NI evaluation was based on a percent reduction from baseline in total IgG levels at day 29 (week 4) using an NI margin of 10%. Only the results for mITT analysis set are entered.||-0.66|-7.73|< 0.0001
72369159|NCT03523988|144248310|SUPERIORITY|||||||0.31||||||P-value for pain scores among the three comparison groups while lightly biting.|ANOVA|||||||0.31
72527594|NCT03474380|144586140|SUPERIORITY|A generalized linear mixed model (GLMM) with a negative binomial distribution and a log link was fit including a time-varying indicator for when iHI-FIVES program launched, fixed effects for time (indicator variables for each of the time periods) and site. The final model was adjusted for Veteran characteristics, including age, gender, race, marital status, service connection, rural status, and chronic disease burden concurrence score (Nosos).|rate ratio (RR)|0.58||||0.091|TWO_SIDED|95.0|0.31|1.09|||generalized linear mixed model (GLMM)||Rate ratio, rate of days not in the community in 6 month intervals in intervention versus usual care.|Days not at home in 6 month intervals.||1.09|0.31|0.091
72527595|NCT03474380|144586141|SUPERIORITY|A generalized linear mixed model (GLMM) was fit including a time-varying indicator for when iHI-FIVES program launched, fixed effects for time (indicator variables for each of the time periods), site, and indicator for the time point of the survey, and an indicator for the interaction of the time point of the survey with the time-varying indicator for treatment. The final model was adjusted for caregiver characteristics.|Mean Difference (Net)|0.0||||0.98|TWO_SIDED|95.0|-0.7|0.8|||Mixed Models Analysis||This is the estimated mean difference from baseline to 3 months between usual care and intervention.|||0.8|-0.7|0.98
72527596|NCT03474380|144586142|SUPERIORITY|A generalized linear mixed model (GLMM) was fit including a time-varying indicator for when iHI-FIVES program launched, fixed effects for time (indicator variables for each of the time periods), site, and indicator for the time point of the survey, and an indicator for the interaction of the time point of the survey with the time-varying indicator for treatment. The final model was adjusted for caregiver characteristics.|Mean Difference (Net)|0.4||||0.167|TWO_SIDED|95.0|-0.2|1.0|||Mixed Models Analysis||This is the estimated mean difference from baseline to 3 months between usual care and intervention.|||1.0|-0.2|0.167
72369160|NCT03523988|144248310|SUPERIORITY|||||||0.37||||||P-value for pain scores among the three comparison groups while chewing paraffin wax.|ANOVA|||||||0.37
72369161|NCT02840461|144248387|EQUIVALENCE|Therapeutic equivalence of the Test product to the Reference product based on the primary endpoint was evaluated in the PP population. If the confidence interval is within 80-125% for the primary endpoint, then the Test and Reference treatments are considered therapeutically equivalent.|Mean Difference (Net)|103.51|||||TWO_SIDED|90.0|97.95|110.0||||||||110.00|97.95|
72369162|NCT02840461|144248387|SUPERIORITY||Mean Difference (Net)|-9.83||||0.0027|TWO_SIDED|95.0|-16.24|-3.42|||ANOVA|||||-3.42|-16.24|0.0027
72527597|NCT03474380|144586143|SUPERIORITY|A generalized linear mixed model (GLMM) was fit including a time-varying indicator for when iHI-FIVES program launched, fixed effects for time (indicator variables for each of the time periods), site, and indicator for the time point of the survey, and an indicator for the interaction of the time point of the survey with the time-varying indicator for treatment. The final model was adjusted for caregiver characteristics.|Mean Difference (Net)|-0.5||||0.122|TWO_SIDED|95.0|-1.0|0.1|||Mixed Models Analysis||This is the estimated mean difference from baseline to 3 months between usual care and intervention.|||0.1|-1.0|0.122
72527598|NCT03288987|144586155|NON_INFERIORITY|Noninferiority was declared by comparing the 90% CI for the hazard ratio (HR) of the AryoGen Pharmed Bevacizumab to the reference product (Roche Bevacizumab) to the point-estimate margin and was based on the synthesis method.|Hazard Ratio (HR)|0.79||||0.47|TWO_SIDED|90.0|0.46|1.35|||Regression, Cox|Upper limit of CI is lower than the noninferiority margin (1.44).|The 90 % CI based on synthesis method is (0.45,1.38). In HR calculation, the AryoGen Pharmed Bevacizumab to Roche Bevacizumab was reported. (reference group was Roche Bevacizumab)|||1.35|0.46|0.47
72527599|NCT03288987|144586156|OTHER||Hazard Ratio (HR)|0.99||||0.99|TWO_SIDED|95.0|0.55|1.8|||Regression, Cox||In HR calculation, the AryoGen Pharmed Bevacizumab to Roche Bevacizumab was reported. (reference group was Roche Bevacizumab)|||1.80|0.55|0.99
72527600|NCT03288987|144586157|OTHER|||||||0.17|||||||Fisher's Exact Test|||||||0.17
72625328|NCT01098747|144780088|SUPERIORITY_OR_OTHER||Difference in proportion|8.86||||0.149|TWO_SIDED|95.0|-3.33|21.04||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1.5 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||21.04|-3.33|0.149
72625329|NCT01098747|144780088|SUPERIORITY_OR_OTHER||Difference in proportion|48.61|||<|0.001|TWO_SIDED|95.0|38.49|58.73||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||2 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||58.73|38.49|<0.001
72369163|NCT02840461|144248387|SUPERIORITY||Mean Difference (Net)|-9.83||||0.0028|TWO_SIDED|95.0|-16.25|-3.4|||ANOVA|||||-3.40|-16.25|0.0028
72369164|NCT02840461|144248388|EQUIVALENCE|If the 90% confidence interval (with Yates correction) for the difference between the proportion of patients in the Test and Reference groups considered to be a clinical success was contained within the pre-defined equivalence limits \[-20%, +20%\], the therapeutic equivalence of the Test to Reference product was considered supported.|Mean Difference (Net)|5.8|||||TWO_SIDED|90.0|-2.7|14.2||||||||14.2|-2.7|
72369165|NCT04672655|144248418|OTHER|||||||0.8875||||||The a priori threshold for statistical significance was \< 0.05.|linear mixed effects models|||A linear mixed effects model (LMM) was used to examine outcomes measured at 3, 6, and 12 months. An unstructured covariance matrix was specified to model within-subject correlations across repeated measurements. To address missing data, the LMM utilized a likelihood-based approach under the missing-at-random (MAR) assumption, which incorporates all available data, thereby minimizing bias from incomplete follow-up measurements.||||0.8875
72527601|NCT03288987|144586158|OTHER||Hazard Ratio (HR)|1.11||||0.59|TWO_SIDED|95.0|0.76|1.61|||Regression, Cox||In HR calculation, the AryoGen Pharmed Bevacizumab to Roche Bevacizumab was reported. (reference group was Roche Bevacizumab)|||1.61|0.76|0.59
72527602|NCT03288987|144586159|OTHER||||||>|0.05|||||||Fisher's Exact Test|||||||>0.05
72527603|NCT04652102|144586170|SUPERIORITY||Proportion|0.364|||||TWO_SIDED|95.826|0.299|0.433|||||Derived from an exact 2-sided 95.826% Pearson-Clopper confidence interval (CI) on proportion of cases coming from the CVnCoV group among all cases.|Proportion of cases coming from the CVnCoV group among all cases.||0.433|0.299|
72527604|NCT04652102|144586170|OTHER||Vaccine Efficacy|48.2||||0.016|TWO_SIDED|95.826|31.0|61.4||1-sided p-value from the exact binomial test on proportion of cases coming from the CVnCoV group among all cases (equivalent to a test on VE with H0: VE ≤30%). Statistically significant if lower than 0.02087.|Exact Binomial Test||2-sided 95.826% CI on VE, derived from the exact 2-sided 95.826% Pearson-Clopper CI on proportion of cases coming from the CVnCoV group among all cases.|Vaccine efficacy (VE) calculated as VE = 1 - p/(1-p) \*1/r where p represents the proportion of cases coming from the CVnCoV group among all cases and r represents the ratio of total follow-up time of subjects in the CVnCoV group over the total follow-up time of subjects in the placebo group.||61.4|31.0|0.01600
72527605|NCT04652102|144586182|SUPERIORITY||Proportion|0.245|||||TWO_SIDED|95.0|0.133|0.389|||||Derived from an exact 2-sided 95% Pearson-Clopper CI on proportion of cases coming from the CVnCoV group among all cases.|Proportion of cases coming from the CVnCoV group among all cases.||0.389|0.133|
72527606|NCT04652102|144586182|SUPERIORITY||Vaccine Efficacy|70.7|||||TWO_SIDED|95.0|42.5|86.1|||||2-sided 95% CI on VE, derived from the exact 2-sided 95% Pearson-Clopper CI on proportion of cases coming from the CVnCoV group among all cases.|VE calculated as VE = 1 - p/(1-p) \*1/r where p represents the proportion of cases coming from the CVnCoV group among all cases and r represents the ratio of total follow-up time of subjects in the CVnCoV group over the total follow-up time of subjects in the placebo group.||86.1|42.5|
72527607|NCT04652102|144586183|SUPERIORITY||Proportion|0.286|||||TWO_SIDED|95.0|0.084|0.581|||||Derived from an exact 2-sided 95% Pearson-Clopper CI on proportion of cases coming from the CVnCoV group among all cases.|Proportion of cases coming from the CVnCoV group among all cases.||0.581|0.084|
72527608|NCT04652102|144586183|SUPERIORITY||Vaccine Efficacy|63.8|||||TWO_SIDED|95.0|-25.5|91.7|||||2-sided 95% CI on VE, derived from the exact 2-sided 95% Pearson-Clopper CI on proportion of cases coming from the CVnCoV group among all cases.|VE calculated as VE = 1 - p/(1-p) \*1/r where p represents the proportion of cases coming from the CVnCoV group among all cases and r represents the ratio of total follow-up time of subjects in the CVnCoV group over the total follow-up time of subjects in the placebo group.||91.7|-25.5|
72527609|NCT04652102|144586184|SUPERIORITY||Proportion|0.341|||||TWO_SIDED|95.0|0.242|0.452|||||Derived from an exact 2-sided 95% Pearson-Clopper CI on proportion of cases coming from the CVnCoV group among all cases.|Proportion of cases coming from the CVnCoV group among all cases.||0.452|0.242|
72527610|NCT04652102|144586184|SUPERIORITY||Vaccine Efficacy|53.2|||||TWO_SIDED|95.0|25.4|71.2|||||2-sided 95% CI on VE, derived from the exact 2-sided 95% Pearson-Clopper CI on proportion of cases coming from the CVnCoV group among all cases.|VE calculated as VE = 1 - p/(1-p) \*1/r where p represents the proportion of cases coming from the CVnCoV group among all cases and r represents the ratio of total follow-up time of subjects in the CVnCoV group over the total follow-up time of subjects in the placebo group.||71.2|25.4|
72527611|NCT04652102|144586185|SUPERIORITY||Proportion|0.571|||||TWO_SIDED|95.0|0.34|0.782|||||Derived from an exact 2-sided 95% Pearson-Clopper CI on proportion of cases coming from the CVnCoV group among all cases.|Proportion of cases coming from the CVnCoV group among all cases.||0.782|0.340|
72527612|NCT04652102|144586185|SUPERIORITY||Vaccine Efficacy|-11.8|||||TWO_SIDED|95.0|-200.5|56.7|||||2-sided 95% CI on VE, derived from the exact 2-sided 95% Pearson-Clopper CI on proportion of cases coming from the CVnCoV group among all cases.|VE calculated as VE = 1 - p/(1-p) \*1/r where p represents the proportion of cases coming from the CVnCoV group among all cases and r represents the ratio of total follow-up time of subjects in the CVnCoV group over the total follow-up time of subjects in the placebo group.||56.7|-200.5|
72527613|NCT00696774|144586199|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.66||||0.005|TWO_SIDED|95.0|-1.12|-0.2|||Adjusted Repeated Measures Analysis|Model terms: baseline score \& CGI, age, sex, country, prev treatment, prev treatment discontinuation reason, response group, visit \& response-by-visit|Least Squares Mean Difference = Responders - Non-Responders.|||-0.20|-1.12|0.005
72527614|NCT00696774|144586201|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.85|||||TWO_SIDED|95.0|-7.34|-4.36|||Adjusted Repeated Measures Analysis|Model terms: baseline score \& CGI, age, sex, country, prev treatment, prev treatment discontinuation reason, response group, visit \& response-by-visit|Least Squares Mean Difference = Responders - Non-Responders.|||-4.36|-7.34|
72527615|NCT00696774|144586202|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.47|||||TWO_SIDED|95.0|-3.13|-1.81|||Adjusted Repeated Measures Analysis|Model terms: baseline score \& CGI, age, sex, country, prev treatment, prev treatment discontinuation reason, response group, visit \& response-by-visit|Least Squares Mean Difference = Responders - Non-Responders.|||-1.81|-3.13|
72527616|NCT00696774|144586203|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.29|||||TWO_SIDED|95.0|-4.1|-2.48|||Adjusted Repeated Measures Analysis|Model terms: baseline score \& CGI, age, sex, country, prev treatment, prev treatment discontinuation reason, response group, visit \& response-by-visit|Least Squares Mean Difference = Responders - Non-Responders.|||-2.48|-4.10|
72527617|NCT00696774|144586204|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.22|||||TWO_SIDED|95.0|-2.89|-1.54|||Adjusted Repeated Measures Analysis|Model terms: baseline score \& CGI, age, sex, country, prev treatment, prev treatment discontinuation reason, response group, visit \& response-by-visit|Least Squares Mean Difference = Responders - Non-Responders.|||-1.54|-2.89|
72527618|NCT00696774|144586205|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.88|||||TWO_SIDED|95.0|-2.45|-1.3|||Adjusted Repeated Measures Analysis|Model terms: baseline score \& CGI, age, sex, country, prev treatment, prev treatment discontinuation reason, response group, visit \& response-by-visit|Least Squares Mean Difference = Responders - Non-Responders.|||-1.30|-2.45|
72527619|NCT00696774|144586206|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.97|||||TWO_SIDED|95.0|-1.31|-0.63|||Adjusted Repeated Measures Analysis|Model terms: baseline score \& CGI, age, sex, country, prev treatment, prev treatment discontinuation reason, response group, visit \& response-by-visit|Least Squares Mean Difference = Responders - Non-Responders.|||-0.63|-1.31|
72527620|NCT00696774|144586207|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.42|||||TWO_SIDED|95.0|-6.04|-2.8|||Adjusted Repeated Measures Analysis|Model terms: baseline score \& CGI, age, sex, country, prev treatment, prev treatment discontinuation reason, response group, visit \& response-by-visit|Least Squares Mean Difference = Responders - Non-Responders.|||-2.80|-6.04|
72527621|NCT00696774|144586208|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.13|||||TWO_SIDED|95.0|-1.42|-0.84|||Adjusted Repeated Measures Analysis|Model terms: baseline score \& CGI, age, sex, country, prev treatment, prev treatment discontinuation reason, response group, visit \& response-by-visit|Least Squares Mean Difference = Responders - Non-Responders.|||-0.84|-1.42|
72527622|NCT00696774|144586209|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.42|||||TWO_SIDED|95.0|-1.08|-0.24|||Adjusted Repeated Measures Analysis|Model terms: baseline score \& CGI, age, sex, country, prev treatment, prev treatment discontinuation reason, response group, visit \& response-by-visit|Least Squares Mean Difference = Responders - Non-Responders.|||-0.24|-1.08|
72527623|NCT00696774|144586210|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.49|||||TWO_SIDED|95.0|-0.81|-0.18|||Adjusted Repeated Measures Analysis|Model terms: baseline score \& CGI, age, sex, country, prev treatment, prev treatment discontinuation reason, response group, visit \& response-by-visit|Least Squares Mean Difference = Responders - Non-Responders.|||-0.18|-0.81|
72527624|NCT00696774|144586211|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.81|||||TWO_SIDED|95.0|-0.99|2.6|||Adjusted Repeated Measures Analysis|Model terms: baseline score \& CGI, age, sex, country, prev treatment, prev treatment discontinuation reason, response group, visit \& response-by-visit|Least Squares Mean Difference = Responders - Non-Responders.|Week 4||2.60|-0.99|
72527625|NCT00696774|144586211|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.36|||||TWO_SIDED|95.0|-0.69|3.42|||Adjusted Repeated Measures Analysis|Model terms: baseline score \& CGI, age, sex, country, prev treatment, prev treatment discontinuation reason, response group, visit \& response-by-visit|Least Squares Mean Difference = Responders - Non-Responders.|Week 8||3.42|-0.69|
72527626|NCT00696774|144586212|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|15.05|||||TWO_SIDED|95.0|10.63|19.47|||Adjusted Repeated Measures Analysis|Model terms: baseline score \& CGI, age, sex, country, prev treatment, prev treatment discontinuation reason, response group, visit \& response-by-visit|Least Squares Mean Difference = Responders - Non-Responders.|Week 4||19.47|10.63|
72527627|NCT00696774|144586212|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.48|||||TWO_SIDED|95.0|4.72|16.24|||Adjusted Repeated Measures Analysis|Model terms: baseline score \& CGI, age, sex, country, prev treatment, prev treatment discontinuation reason, response group, visit \& response-by-visit|Least Squares Mean Difference = Responders - Non-Responders.|Week 8||16.24|4.72|
72527628|NCT00696774|144586213|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.88|||||TWO_SIDED|95.0|-7.75|-4.02|||Adjusted Repeated Measures Analysis|Model terms: baseline score \& CGI, age, sex, country, prev treatment, prev treatment discontinuation reason, response group, visit \& response-by-visit|Least Squares Mean Difference = Responders - Non-Responders.|Week 4||-4.02|-7.75|
72527629|NCT00696774|144586213|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.59|||||TWO_SIDED|95.0|-6.65|-2.54|||Adjusted Repeated Measures Analysis|Model terms: baseline score \& CGI, age, sex, country, prev treatment, prev treatment discontinuation reason, response group, visit \& response-by-visit|Least Squares Mean Difference = Responders - Non-Responders.|Week 8||-2.54|-6.65|
72527630|NCT03490734|144586224|SUPERIORITY|||||||0.52||||||Corrected for multiple comparisons by using the threshold free cluster enhancement, nonparametric thresholding algorithm in FMRIB Software Library (FSL), resulting in a family-wise error rate (FWE) corrected significance threshold of p-FWE\<0.05|ANCOVA|||Whole-brain analyses were used. No clusters of significant activation were detected.||||0.52
72527631|NCT03490734|144586225|SUPERIORITY|||||||0.016||||||Corrected for multiple comparisons by using the threshold free cluster enhancement (TFCE), nonparametric thresholding algorithm in FSL, resulting in a family-wise error rate corrected significance threshold of p-FWE \< 0.05|ANCOVA|||||||0.016
72527632|NCT02442765|144586244|SUPERIORITY||Least Squares Mean Difference|-4.0|||=|0.021|TWO_SIDED|95.0|-7.4|-0.6||MMRMs include fixed effects of treatment, visit, treatment-by-visit, BL, BL-by-visit, and in the Stage 1 model, BL NPI AA, risk assessment for falls, BL concomitant antipsychotic medication use. Unstructured variance-covariance was used.|mixed model repeated measures (MMRM)|||||-0.6|-7.4|=0.021
72527633|NCT02442765|144586244|SUPERIORITY||Least Squares Mean Difference|-0.6|||=|0.731|TWO_SIDED|95.0|-3.9|2.7||MMRMs include fixed effects of treatment, visit, treatment-by-visit, BL, BL-by-visit, and in the Stage 1 model, BL NPI AA, risk assessment for falls, BL concomitant antipsychotic medication use. Unstructured variance-covariance was used.|MMRM|||||2.7|-3.9|=0.731
72527634|NCT02442765|144586244|SUPERIORITY||Least Squares Mean Difference|-3.5|||=|0.157|TWO_SIDED|95.0|-8.4|1.4||MMRMs include fixed effects of treatment, visit, treatment-by-visit, BL, BL-by-visit, and in the Stage 1 model, BL NPI AA, risk assessment for falls, BL concomitant antipsychotic medication use. Unstructured variance-covariance was used.|MMRM|||||1.4|-8.4|=0.157
72527635|NCT02442765|144586244|SUPERIORITY||Least Squares Mean Difference|-3.6|||=|0.15|TWO_SIDED|95.0|-8.4|1.3||"MMRMs include fixed effects of treatment, visit, treatment-by-visit, BL, BL-by-visit, and in the Stage 1 model, BL NPI AA, risk assessment for falls, BL concomitant antipsychotic medication use.~Unstructured variance-covariance was used."|MMRM|||||1.3|-8.4|=0.150
72527636|NCT02442765|144586244|SUPERIORITY||MMRM weighted z-statistic|-2.65|||=|0.008|TWO_SIDED|||||"MMRMs include fixed effects of treatment, visit, treatment-by-visit, BL, BL-by-visit, and in the Stage 1 model, BL NPI AA, risk assessment for falls, BL concomitant antipsychotic medication use.~Unstructured variance-covariance was used."|MMRM|Sequential Parallel Comparison Design (SPCD) was used with weight = 0.6 for Stage 1 and 0.4 for Stage 2.||||||=0.008
72527637|NCT02442765|144586244|SUPERIORITY||MMRM weighted z-statistic|-1.26|||=|0.208|TWO_SIDED|||||MMRMs include fixed effects of treatment, visit, treatment-by-visit, BL, BL-by-visit, and in the Stage 1 model, BL NPI AA, risk assessment for falls, BL concomitant antipsychotic medication use. Unstructured variance-covariance was used.|MMRM|SPCD was used with weight = 0.6 for Stage 1 and 0.4 for Stage 2.||||||=0.208
72527638|NCT02442765|144586245|SUPERIORITY||Least Squares Mean Difference|-0.1||||0.331|TWO_SIDED|95.0|-0.4|0.1|||ANCOVA|||||0.1|-0.4|0.331
72527639|NCT02442765|144586245|SUPERIORITY||Least Squares Mean Difference|-0.1||||0.4|TWO_SIDED|95.0|-0.4|0.2|||ANCOVA|||||0.2|-0.4|0.400
72527640|NCT02442765|144586245|SUPERIORITY||Least Squares Mean Difference|-0.6||||0.014|TWO_SIDED|95.0|-1.1|-0.1|||ANCOVA|||||-0.1|-1.1|0.014
72527641|NCT02442765|144586245|SUPERIORITY||Least Squares Mean Difference|-0.4||||0.145|TWO_SIDED|95.0|-0.9|0.1|||ANCOVA|||||0.1|-0.9|0.145
72527642|NCT02442765|144586245|SUPERIORITY||SPCD OLS weighted z-statistic|-2.51||||0.012|TWO_SIDED||||||ANCOVA||OLS = ordinary least squares|||||0.012
72527643|NCT02442765|144586245|SUPERIORITY||SPCD OLS weighted z-statistic|-1.66||||0.097|TWO_SIDED||||||ANCOVA|||||||0.097
72527644|NCT02442765|144586246|SUPERIORITY||Least Squares Mean Difference|-0.5|||=|0.182|TWO_SIDED|95.0|-1.3|0.2||MMRMs include fixed effects of treatment, visit, treatment-by-visit, BL, BL-by-visit, and in the Stage 1 model, BL NPI AA, risk assessment for falls, BL concomitant antipsychotic medication use. Unstructured variance-covariance was used.|MMRM|SPCD was used with weight = 0.6 for Stage 1 and 0.4 for Stage 2.||||0.2|-1.3|=0.182
72527645|NCT02442765|144586246|SUPERIORITY||Least Squares Mean Difference|-0.3|||=|0.39|TWO_SIDED|95.0|-1.1|0.4||"MMRMs include fixed effects of treatment, visit, treatment-by-visit, BL, BL-by-visit, and in the Stage 1 model, BL NPI AA, risk assessment for falls, BL concomitant antipsychotic medication use.~Unstructured variance-covariance was used."|MMRM|||||0.4|-1.1|=0.390
72527646|NCT02442765|144586246|SUPERIORITY||Least Squares Mean Difference|0.5|||=|0.462|TWO_SIDED|95.0|-0.8|1.7||"MMRMs include fixed effects of treatment, visit, treatment-by-visit, BL, BL-by-visit, and in the Stage 1 model, BL NPI AA, risk assessment for falls, BL concomitant antipsychotic medication use.~Unstructured variance-covariance was used."|MMRM|||||1.7|-0.8|=0.462
72527647|NCT02442765|144586246|SUPERIORITY||Least Squares Mean Difference|0.4|||=|0.528|TWO_SIDED|95.0|-0.8|1.6||"MMRMs include fixed effects of treatment, visit, treatment-by-visit, BL, BL-by-visit, and in the Stage 1 model, BL NPI AA, risk assessment for falls, BL concomitant antipsychotic medication use.~Unstructured variance-covariance was used."|MMRM|||||1.6|-0.8|=0.528
72527648|NCT02442765|144586246|SUPERIORITY||MMRM weighted z-statistic|-0.39|||=|0.695|TWO_SIDED|||||"MMRMs include fixed effects of treatment, visit, treatment-by-visit, Baseline (BL), BL-by-visit, and in the Stage 1 model, BL NPI AA, risk assessment for falls, BL concomitant antipsychotic medication use.~Unstructured variance-covariance was used."|ANCOVA|||||||=0.695
72407283|NCT02346240|144323017|SUPERIORITY||Odds Ratio (OR)|49.527|||<|0.0001|TWO_SIDED|95.0|10.002|245.256||The p-value is evaluated at a 2-sided significance level for CZP 200 mg vs. PBO|Regression, Logistic|Odds ratios, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.||The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||245.256|10.002|<0.0001
72407284|NCT01573624|144323021|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.026||||0.264|TWO_SIDED|95.0|-0.019|0.071|||Mixed Models Analysis|||No pairwise comparisons between doses of FF + UMEC and FF alone were done unless overall F-test for treatment effect was statistically significant at 5% level. Multiplicity across these comparisons was controlled using a step-down closed testing procedure, whereby statistical comparison of the highest dose of FF + UMEC and FF alone was initially performed, and subsequent comparisons at lower doses continued in a step-down manner if preceding comparison was statistically significant at 5% level.||0.071|-0.019|0.264
72407285|NCT01573624|144323021|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.033||||0.165|TWO_SIDED|95.0|-0.013|0.079|||Mixed Models Analysis|||No pairwise comparisons between doses of FF + UMEC and FF alone were done unless overall F-test for treatment effect was statistically significant at 5% level. Multiplicity across these comparisons was controlled using a step-down closed testing procedure, whereby statistical comparison of the highest dose of FF + UMEC and FF alone was initially performed, and subsequent comparisons at lower doses continued in a step-down manner if preceding comparison was statistically significant at 5% level.||0.079|-0.013|0.165
72407286|NCT01573624|144323021|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.026||||0.271|TWO_SIDED|95.0|-0.02|0.071|||Mixed Models Analysis|||No pairwise comparisons between doses of FF + UMEC and FF alone were done unless overall F-test for treatment effect was statistically significant at 5% level. Multiplicity across these comparisons was controlled using a step-down closed testing procedure, whereby statistical comparison of the highest dose of FF + UMEC and FF alone was initially performed, and subsequent comparisons at lower doses continued in a step-down manner if preceding comparison was statistically significant at 5% level.||0.071|-0.020|0.271
72407287|NCT01573624|144323021|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.055||||0.018|TWO_SIDED|95.0|0.01|0.1|||Mixed Models Analysis|||No pairwise comparisons between doses of FF + UMEC and FF alone were done unless overall F-test for treatment effect was statistically significant at 5% level. Multiplicity across these comparisons was controlled using a step-down closed testing procedure, whereby statistical comparison of the highest dose of FF + UMEC and FF alone was initially performed, and subsequent comparisons at lower doses continued in a step-down manner if preceding comparison was statistically significant at 5% level.||0.100|0.010|0.018
72407288|NCT01573624|144323021|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.055||||0.018|TWO_SIDED|95.0|0.01|0.101|||Mixed Models Analysis|||No pairwise comparisons between doses of FF + UMEC and FF alone were done unless overall F-test for treatment effect was statistically significant at 5% level. Multiplicity across these comparisons was controlled using a step-down closed testing procedure, whereby statistical comparison of the highest dose of FF + UMEC and FF alone was initially performed, and subsequent comparisons at lower doses continued in a step-down manner if preceding comparison was statistically significant at 5% level.||0.101|0.010|0.018
72407289|NCT01573624|144323021|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.078|||<|0.001|TWO_SIDED|95.0|0.032|0.124|||Mixed Models Analysis|||||0.124|0.032|<0.001
72571534|NCT00117325|144671702|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.601||||0.038|TWO_SIDED|95.0|-1.17|-0.03|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for PM rTNSS at Day 28||-0.03|-1.17|0.038
72407290|NCT01573624|144323021|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.052||||0.023|TWO_SIDED|95.0|-0.097|-0.007|||Mixed Models Analysis|||No adjustments were made for comparisons between doses of FF + UMEC and FF + VI.||-0.007|-0.097|0.023
72527649|NCT02442765|144586246|SUPERIORITY||MMRM weighted z-statistic|-0.12|||=|0.904|TWO_SIDED|||||"MMRMs include fixed effects of treatment, visit, treatment-by-visit, Baseline (BL), BL-by-visit, and in the Stage 1 model, BL NPI AA, risk assessment for falls, BL concomitant antipsychotic medication use.~Unstructured variance-covariance was used."|ANCOVA|||||||=0.904
72527650|NCT02442765|144586247|SUPERIORITY||Least Squares Mean Difference|-1.2|||=|0.247|TWO_SIDED|95.0|-3.2|0.8||"MMRMs include fixed effects of treatment, visit, treatment-by-visit, BL, BL-by-visit, and in the Stage 1 model, BL NPI AA, risk assessment for falls, BL concomitant antipsychotic medication use.~Unstructured variance-covariance was used."|MMRM|||||0.8|-3.2|=0.247
72407291|NCT01573624|144323021|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.045||||0.051|TWO_SIDED|95.0|-0.091|0.0|||Mixed Models Analysis|||No adjustments were made for comparisons between doses of FF + UMEC and FF + VI.||0.000|-0.091|0.051
72407292|NCT01573624|144323021|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.053||||0.023|TWO_SIDED|95.0|-0.098|-0.007|||Mixed Models Analysis|||No adjustments were made for comparisons between doses of FF + UMEC and FF + VI.||-0.007|-0.098|0.023
72407293|NCT01573624|144323021|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.023||||0.306|TWO_SIDED|95.0|-0.068|0.021|||Mixed Models Analysis|||No adjustments were made for comparisons between doses of FF + UMEC and FF + VI.||0.021|-0.068|0.306
72571535|NCT00759187|144671703|SUPERIORITY_OR_OTHER||||||<|0.05||95.0||||Two way Anova general linear model (subject and treatment as factors)|ANOVA|||||||<0.05
72407294|NCT01573624|144323021|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.023||||0.33|TWO_SIDED|95.0|-0.068|0.023|||Mixed Models Analysis|||No adjustments were made for comparisons between doses of FF + UMEC and FF + VI.||0.023|-0.068|0.330
72571536|NCT00296231|144671704|SUPERIORITY_OR_OTHER|||||||0.011||95.0|||||t-test, 2 sided|||Paired Student's t-test was used to compare pre and post intervention pCO2 values.||||0.011
72571537|NCT01568320|144671730|SUPERIORITY_OR_OTHER_LEGACY||Freedom from Major adverse events (%)|71.6|||||TWO_SIDED|95.0|59.0|82.0|||||Clopper-Pearson (Exact) Method|||82|59|
72571538|NCT01568320|144671731|SUPERIORITY_OR_OTHER_LEGACY||Survival rate (%)|95.5|||||TWO_SIDED|95.0|87.0|99.0|||||Clopper-Pearson (Exact) Method|||99|87|
72625330|NCT01098747|144780088|SUPERIORITY_OR_OTHER||Difference in proportion|4.55||||0.477|TWO_SIDED|95.0|-8.03|17.13||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||2 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||17.13|-8.03|0.477
72625331|NCT01098747|144780088|SUPERIORITY_OR_OTHER||Difference in proportion|52.81|||<|0.001|TWO_SIDED|95.0|42.63|62.99||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||3 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||62.99|42.63|<0.001
72527651|NCT02442765|144586247|SUPERIORITY||Least Squares Mean Difference|-0.4|||=|0.721|TWO_SIDED|95.0|-2.3|1.6||"MMRMs include fixed effects of treatment, visit, treatment-by-visit, BL, BL-by-visit, and in the Stage 1 model, BL NPI AA, risk assessment for falls, BL concomitant antipsychotic medication use.~Unstructured variance-covariance was used."|MMRM|||||1.6|-2.3|=0.721
72527652|NCT02442765|144586247|SUPERIORITY||Least Squares Mean Difference|-1.2|||=|0.419|TWO_SIDED|95.0|-4.3|1.8||"MMRMs include fixed effects of treatment, visit, treatment-by-visit, BL, BL-by-visit, and in the Stage 1 model, BL NPI AA, risk assessment for falls, BL concomitant antipsychotic medication use.~Unstructured variance-covariance was used."|MMRM|||||1.8|-4.3|=0.419
72527653|NCT02442765|144586247|SUPERIORITY||Least Squares Mean Difference|0.9|||=|0.534|TWO_SIDED|95.0|-2.0|3.9||"MMRMs include fixed effects of treatment, visit, treatment-by-visit, BL, BL-by-visit, and in the Stage 1 model, BL NPI AA, risk assessment for falls, BL concomitant antipsychotic medication use.~Unstructured variance-covariance was used."|MMRM|||||3.9|-2.0|=0.534
72527654|NCT02442765|144586247|SUPERIORITY||MMRM weighted z-statistic|-1.4|||=|0.163|TWO_SIDED||||||ANCOVA|||||||=0.163
72527655|NCT02442765|144586247|SUPERIORITY||MMRM weighted z-statistic|0.19|||=|0.851|TWO_SIDED||||||ANCOVA|||||||=0.851
72527656|NCT02442765|144586248|SUPERIORITY||Least Squares Mean Difference|-0.6|||=|0.146|TWO_SIDED|95.0|-1.4|0.2||"MMRMs include fixed effects of treatment, visit, treatment-by-visit, BL, BL-by-visit, and in the Stage 1 model, BL NPI AA, risk assessment for falls, BL concomitant antipsychotic medication use.~Unstructured variance-covariance was used."|MMRM|||||0.2|-1.4|=0.146
72527657|NCT02442765|144586248|SUPERIORITY||Least Squares Mean Difference|0.3|||=|0.399|TWO_SIDED|95.0|-0.4|1.1||"MMRMs include fixed effects of treatment, visit, treatment-by-visit, BL, BL-by-visit, and in the Stage 1 model, BL NPI AA, risk assessment for falls, BL concomitant antipsychotic medication use.~Unstructured variance-covariance was used."|MMRM|||||1.1|-0.4|=0.399
72527658|NCT02442765|144586248|SUPERIORITY||Least Squares Mean Difference|0.7|||=|0.283|TWO_SIDED|95.0|-0.6|2.0||"MMRMs include fixed effects of treatment, visit, treatment-by-visit, BL, BL-by-visit, and in the Stage 1 model, BL NPI AA, risk assessment for falls, BL concomitant antipsychotic medication use.~Unstructured variance-covariance was used."|MMRM|||||2.0|-0.6|=0.283
72527659|NCT02442765|144586248|SUPERIORITY||Least Squares Mean Difference|1.2|||=|0.065|TWO_SIDED|95.0|-0.1|2.5||"MMRMs include fixed effects of treatment, visit, treatment-by-visit, BL, BL-by-visit, and in the Stage 1 model, BL NPI AA, risk assessment for falls, BL concomitant antipsychotic medication use.~Unstructured variance-covariance was used."|MMRM|||||2.5|-0.1|=0.065
72527660|NCT02442765|144586248|SUPERIORITY||MMRM weighted z-statistic|-0.22|||=|0.829|TWO_SIDED||||||ANCOVA|||||||=0.829
72527661|NCT02442765|144586248|SUPERIORITY||MMRM weighted z-statistic|1.94|||=|0.052|TWO_SIDED||||||ANCOVA|||||||=0.052
72527662|NCT02442765|144586249|SUPERIORITY||Least Squares Mean Difference|-0.7|||=|0.53|TWO_SIDED|95.0|-2.7|1.4|||ANCOVA|||||1.4|-2.7|=0.530
72527663|NCT02442765|144586249|SUPERIORITY||Least Squares Mean Difference|-1.0|||=|0.326|TWO_SIDED|95.0|-3.1|1.0|||ANCOVA|||||1.0|-3.1|=0.326
72527664|NCT02442765|144586249|SUPERIORITY||Least Squares Mean Difference|2.5|||=|0.135|TWO_SIDED|95.0|-0.8|5.9|||ANCOVA|||||5.9|-0.8|=0.135
72527665|NCT02442765|144586249|SUPERIORITY||Least Squares Mean Difference|0.2|||=|0.895|TWO_SIDED|95.0|-3.1|3.5|||ANCOVA|||||3.5|-3.1|=0.895
72527666|NCT02442765|144586249|SUPERIORITY||SPCD OLS weighted Z-statistic|0.67|||=|0.502|TWO_SIDED||||||ANCOVA|||||||=0.502
72527667|NCT02442765|144586249|SUPERIORITY||SPCD OLS weighted Z-statistic|-0.58|||=|0.564|TWO_SIDED||||||ANCOVA|||||||=0.564
72527668|NCT02442765|144586250|SUPERIORITY||Least Squares Mean Difference|-0.8|||=|0.061|TWO_SIDED|95.0|-1.6|0.0||"MMRMs include fixed effects of treatment, visit, treatment-by-visit, BL, BL-by-visit, and in the Stage 1 model, BL NPI AA, risk assessment for falls, BL concomitant antipsychotic medication use.~Unstructured variance-covariance was used."|MMRM|||||0.0|-1.6|=0.061
72527669|NCT02442765|144586250|SUPERIORITY||Least Squares Mean Difference|-0.3|||=|0.4|TWO_SIDED|95.0|-1.1|0.5||"MMRMs include fixed effects of treatment, visit, treatment-by-visit, BL, BL-by-visit, and in the Stage 1 model, BL NPI AA, risk assessment for falls, BL concomitant antipsychotic medication use.~Unstructured variance-covariance was used."|MMRM|||||0.5|-1.1|=0.400
72527670|NCT02442765|144586250|SUPERIORITY||Least Squares Mean Difference|-1.1|||=|0.115|TWO_SIDED|95.0|-2.4|0.3||"MMRMs include fixed effects of treatment, visit, treatment-by-visit, BL, BL-by-visit, and in the Stage 1 model, BL NPI AA, risk assessment for falls, BL concomitant antipsychotic medication use.~Unstructured variance-covariance was used."|MMRM|||||0.3|-2.4|=0.115
72527671|NCT02442765|144586250|SUPERIORITY||Least Squares Mean Difference|-0.8|||=|0.264|TWO_SIDED|95.0|-2.1|0.6||"MMRMs include fixed effects of treatment, visit, treatment-by-visit, BL, BL-by-visit, and in the Stage 1 model, BL NPI AA, risk assessment for falls, BL concomitant antipsychotic medication use.~Unstructured variance-covariance was used."|MMRM|||||0.6|-2.1|=0.264
72527672|NCT02442765|144586250|SUPERIORITY||MMRM weighted z-statistic|-2.44|||=|0.015|TWO_SIDED||||||ANCOVA|||||||=0.015
72527673|NCT02442765|144586250|SUPERIORITY||MMRM weighted z-statistic|-1.4|||=|0.163|TWO_SIDED||||||ANCOVA|||||||=0.163
72527674|NCT02442765|144586251|SUPERIORITY||Least Squares Mean Difference|-3.9|||=|0.05|TWO_SIDED|95.0|-7.8|0.0||"MMRMs include fixed effects of treatment, visit, treatment-by-visit, BL, BL-by-visit, and in the Stage 1 model, BL NPI AA, risk assessment for falls, BL concomitant antipsychotic medication use.~Unstructured variance-covariance was used."|MMRM|||||-0.0|-7.8|=0.050
72407295|NCT01573624|144323022|SUPERIORITY_OR_OTHER||Mean Difference (Net)|15.9|||<|0.001|TWO_SIDED|95.0|9.5|22.3|||Mixed Models Analysis|||No pairwise comparisons between doses of FF + UMEC and FF alone were done unless overall F-test for treatment effect was statistically significant at 5% level. Multiplicity across these comparisons was controlled using a step-down closed testing procedure, whereby statistical comparison of the highest dose of FF + UMEC and FF alone was initially performed, and subsequent comparisons at lower doses continued in a step-down manner if preceding comparison was statistically significant at 5% level.||22.3|9.5|<0.001
72407296|NCT01573624|144323022|SUPERIORITY_OR_OTHER||Mean Difference (Net)|17.4|||<|0.001|TWO_SIDED|95.0|10.9|23.9|||Mixed Models Analysis|||No pairwise comparisons between doses of FF + UMEC and FF alone were done unless overall F-test for treatment effect was statistically significant at 5% level. Multiplicity across these comparisons was controlled using a step-down closed testing procedure, whereby statistical comparison of the highest dose of FF + UMEC and FF alone was initially performed, and subsequent comparisons at lower doses continued in a step-down manner if preceding comparison was statistically significant at 5% level.||23.9|10.9|<0.001
72527675|NCT02442765|144586251|SUPERIORITY||Least Squares Mean Difference|-1.6|||=|0.412|TWO_SIDED|95.0|-5.4|2.2||"MMRMs include fixed effects of treatment, visit, treatment-by-visit, BL, BL-by-visit, and in the Stage 1 model, BL NPI AA, risk assessment for falls, BL concomitant antipsychotic medication use.~Unstructured variance-covariance was used."|MMRM|||||2.2|-5.4|=0.412
72527676|NCT02442765|144586251|SUPERIORITY||Least Squares Mean Difference|-1.0|||=|0.775|TWO_SIDED|95.0|-7.8|5.8||"MMRMs include fixed effects of treatment, visit, treatment-by-visit, BL, BL-by-visit, and in the Stage 1 model, BL NPI AA, risk assessment for falls, BL concomitant antipsychotic medication use.~Unstructured variance-covariance was used."|MMRM|||||5.8|-7.8|=0.775
72527677|NCT02442765|144586251|SUPERIORITY||Least Squares Mean Difference|3.3|||=|0.333|TWO_SIDED|95.0|-3.5|10.1||"MMRMs include fixed effects of treatment, visit, treatment-by-visit, BL, BL-by-visit, and in the Stage 1 model, BL NPI AA, risk assessment for falls, BL concomitant antipsychotic medication use.~Unstructured variance-covariance was used."|MMRM|||||10.1|-3.5|=0.333
72527678|NCT02442765|144586251|SUPERIORITY||MMRM weighted z-statistic|-1.5|||=|0.133|TWO_SIDED||||||ANCOVA|||||||=0.133
72527679|NCT02442765|144586251|SUPERIORITY||MMRM weighted z-statistic|0.22|||=|0.829|TWO_SIDED||||||ANCOVA|||||||=0.829
72527680|NCT02442765|144586252|SUPERIORITY||Least Squares Mean Difference|-0.2|||=|0.118|TWO_SIDED|95.0|-0.4|0.0|||ANCOVA|||||0.0|-0.4|=0.118
72527681|NCT02442765|144586252|SUPERIORITY||Least Squares Mean Difference|-0.1|||=|0.191|TWO_SIDED|95.0|-0.4|0.1|||ANCOVA|||||0.1|-0.4|=0.191
72527682|NCT02442765|144586252|SUPERIORITY||Least Squares Mean Difference|-0.2|||=|0.225|TWO_SIDED|95.0|-0.5|0.1|||ANCOVA|||||0.1|-0.5|=0.225
72527683|NCT02442765|144586252|SUPERIORITY||Least Squares Mean Difference|-0.2|||=|0.227|TWO_SIDED|95.0|-0.5|0.1|||ANCOVA|||||0.1|-0.5|=0.227
72527684|NCT02442765|144586252|SUPERIORITY||SPCD OLS weighted z-statistic|-1.97|||=|0.049|TWO_SIDED||||||ANCOVA|||||||=0.049
72625332|NCT01098747|144780088|SUPERIORITY_OR_OTHER||Difference in proportion|-2.14||||0.739|TWO_SIDED|95.0|-14.77|10.5||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||3 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||10.50|-14.77|0.739
72527685|NCT02442765|144586252|SUPERIORITY||SPCD OLS weighted z-statistic|-1.78|||=|0.075|TWO_SIDED||||||ANCOVA|||||||=0.075
72527686|NCT02442765|144586253|SUPERIORITY||Least Squares Mean Difference|-0.1|||=|0.364|TWO_SIDED|95.0|-0.4|0.1|||ANCOVA|||||0.1|-0.4|=0.364
72527687|NCT02442765|144586253|SUPERIORITY||Least Squares Mean Difference|-0.1|||=|0.427|TWO_SIDED|95.0|-0.4|0.2|||ANCOVA|||||0.2|-0.4|=0.427
72527688|NCT02442765|144586253|SUPERIORITY||Least Squares Mean Difference|-0.4|||=|0.098|TWO_SIDED|95.0|-0.9|0.1|||ANCOVA|||||0.1|-0.9|=0.098
72527689|NCT02442765|144586253|SUPERIORITY||Least Squares Mean Difference|-0.3|||=|0.168|TWO_SIDED|95.0|-0.8|0.1|||ANCOVA|||||0.1|-0.8|=0.168
72527690|NCT02442765|144586253|SUPERIORITY||SPCD OLS weighted z-statistic|-1.86|||=|0.063|TWO_SIDED||||||ANCOVA|||||||=0.063
72527691|NCT02442765|144586253|SUPERIORITY||SPCD OLS weighted z-statistic|-1.57|||=|0.115|TWO_SIDED||||||ANCOVA|||||||=0.115
72527692|NCT02442765|144586254|SUPERIORITY||Least Squares Mean Difference|-0.4|||=|0.014|TWO_SIDED|95.0|-0.6|-0.1|||ANCOVA|||||-0.1|-0.6|=0.014
72527693|NCT02442765|144586254|SUPERIORITY||Least Squares Mean Difference|-0.2|||=|0.111|TWO_SIDED|95.0|-0.5|0.1|||ANCOVA|||||0.1|-0.5|=0.111
72527694|NCT02442765|144586254|SUPERIORITY||Least Squares Mean Difference|-0.5|||=|0.062|TWO_SIDED|95.0|-1.1|0.0|||ANCOVA|||||0.0|-1.1|=0.062
72527695|NCT02442765|144586254|SUPERIORITY||Least Squares Mean Difference|-0.3|||=|0.305|TWO_SIDED|95.0|-0.8|0.3|||ANCOVA|||||0.3|-0.8|=0.305
72527696|NCT02442765|144586254|SUPERIORITY||SPCD OLS weighted z-statistic|-3.01|||=|0.003|TWO_SIDED||||||ANCOVA|||||||=0.003
72527697|NCT02442765|144586254|SUPERIORITY||SPCD OLS weighted z-statistic|-1.79|||=|0.073|TWO_SIDED||||||ANCOVA|||||||=0.073
72527698|NCT02442765|144586255|SUPERIORITY||Least Squares Mean Difference|0.1|||=|0.909|TWO_SIDED|95.0|-2.2|2.5|||ANCOVA|||||2.5|-2.2|=0.909
72625333|NCT01098747|144780088|SUPERIORITY_OR_OTHER||Difference in proportion|48.53|||<|0.001|TWO_SIDED|95.0|36.29|60.77||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||4 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||60.77|36.29|<0.001
72527699|NCT02442765|144586255|SUPERIORITY||Least Squares Mean Difference|1.4|||=|0.226|TWO_SIDED|95.0|-0.9|3.8|||ANCOVA|||||3.8|-0.9|=0.226
72527700|NCT02442765|144586255|SUPERIORITY||Least Squares Mean Difference|2.1|||=|0.405|TWO_SIDED|95.0|-2.9|7.1|||ANCOVA|||||7.1|-2.9|=0.405
72527701|NCT02442765|144586255|SUPERIORITY||Least Squares Mean Difference|-0.9|||=|0.714|TWO_SIDED|95.0|-5.8|4.0|||ANCOVA|||||4.0|-5.8|=0.714
72527702|NCT02442765|144586255|SUPERIORITY||SPCD OLS weighted z-statistic|0.75|||=|0.456|TWO_SIDED||||||ANCOVA|||||||=0.456
72527703|NCT02442765|144586255|SUPERIORITY||SPCD OLS weighted z-statistic|0.42|||=|0.678|TWO_SIDED||||||ANCOVA|||||||=0.678
72527704|NCT02442765|144586256|SUPERIORITY||Least Squares Mean Difference|-0.4|||=|0.278|TWO_SIDED|95.0|-1.1|0.3|||ANCOVA|||||0.3|-1.1|=0.278
72527705|NCT02442765|144586256|SUPERIORITY||Least Squares Mean Difference|-0.1|||=|0.817|TWO_SIDED|95.0|-0.8|0.6|||ANCOVA|||||0.6|-0.8|=0.817
72527706|NCT02442765|144586256|SUPERIORITY||Least Squares Mean Difference|-0.4|||=|0.5|TWO_SIDED|95.0|-1.4|0.7|||ANCOVA|||||0.7|-1.4|=0.500
72527707|NCT02442765|144586256|SUPERIORITY||Least Squares Mean Difference|0.1|||=|0.795|TWO_SIDED|95.0|-0.9|1.2|||ANCOVA|||||1.2|-0.9|=0.795
72527708|NCT02442765|144586256|SUPERIORITY||SPCD OLS weighted z-statistic|-1.25|||=|0.213|TWO_SIDED||||||ANCOVA|||||||=0.213
72527709|NCT02442765|144586256|SUPERIORITY||SPCD OLS weighted z-statistic|0.02|||=|0.985|TWO_SIDED||||||ANCOVA|||||||=0.985
72527710|NCT02442765|144586258|SUPERIORITY||Least Squares Mean Difference|-1.6|||=|0.018|TWO_SIDED|95.0|-2.9|-0.3|||ANCOVA|||||-0.3|-2.9|=0.018
72527711|NCT02442765|144586258|SUPERIORITY||Least Squares Mean Difference|0.0|||=|0.956|TWO_SIDED|95.0|-1.3|1.3|||ANCOVA|||||1.3|-1.3|=0.956
72527712|NCT02442765|144586258|SUPERIORITY||Least Squares Mean Difference|1.1|||=|0.451|TWO_SIDED|95.0|-1.8|4.0|||ANCOVA|||||4.0|-1.8|=0.451
72527713|NCT02442765|144586258|SUPERIORITY||Least Squares Mean Difference|0.9|||=|0.519|TWO_SIDED|95.0|-1.9|3.7|||ANCOVA|||||3.7|-1.9|=0.519
72527714|NCT02442765|144586258|SUPERIORITY||SPCD OLS weighted z-statistic|-0.72|||=|0.471|TWO_SIDED||||||ANCOVA|||||||=0.471
72527715|NCT02442765|144586258|SUPERIORITY||SPCD OLS weighted z-statistic|0.5|||=|0.618|TWO_SIDED||||||ANCOVA|||||||=0.618
72527716|NCT01200758|144586265|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferior Ctrough in SC formulation was demonstrated, if the lower bound of 90% confidence interval (CI) was above 0.8.|Geometric mean ratio|1.62|||||TWO_SIDED|90.0|1.36|1.94|||||Geometric mean ratio adjusted for tumor load at baseline.|||1.94|1.36|
72527717|NCT01200758|144586266|SUPERIORITY_OR_OTHER||Difference in response rates|-4.82||||0.2835|TWO_SIDED|95.0|-14.0|4.4|||Chi-squared||The 95% CI for the difference in response rates was estimated using the Hauck-Anderson method.|||4.4|-14.0|0.2835
72527718|NCT01200758|144586266|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.71|||||TWO_SIDED|95.0|0.38|1.33||||||||1.33|0.38|
72527719|NCT01200758|144586267|SUPERIORITY_OR_OTHER||Difference in response rates|7.66||||0.2047|TWO_SIDED|95.0|-5.0|20.3|||Chi-squared||The 95% CI for the difference in response rates was estimated using the Hauck-Anderson method.|||20.3|-5.0|0.2047
72527720|NCT01200758|144586267|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.97|||||TWO_SIDED|95.0|0.68|5.71||||||||5.71|0.68|
72527721|NCT01200758|144586268|SUPERIORITY_OR_OTHER||Difference in response rates|-0.49||||0.8911|TWO_SIDED|95.0|-7.7|6.8|||Chi-squared||The 95% CI for the difference in response rates was estimated using the Hauck-Anderson.|||6.8|-7.7|0.8911
72527722|NCT01200758|144586268|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.96|||||TWO_SIDED|95.0|0.56|1.65||||||||1.65|0.56|
72527723|NCT01200758|144586269|SUPERIORITY_OR_OTHER||Difference in CRR|17.86||||0.0335|TWO_SIDED|95.0|0.8|35.0|||Chi-squared||The 95% CI for the difference in response rates was estimated using the Hauck-Anderson method.|||35.0|0.8|0.0335
72527724|NCT01200758|144586269|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.25|||||TWO_SIDED|95.0|1.06|4.78||||||||4.78|1.06|
72527725|NCT01200758|144586270|SUPERIORITY_OR_OTHER||Difference in response rates|-6.58||||0.2331|TWO_SIDED|95.0|-17.8|4.6|||Chi-squared||The 95% CI for the difference in response rates was estimated using the Hauck-Anderson method.|||4.6|-17.8|0.2331
72527726|NCT01200758|144586270|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.74|||||TWO_SIDED|95.0|0.44|1.22||||||||1.22|0.44|
72527727|NCT01200758|144586271|SUPERIORITY_OR_OTHER||Difference in response rates|0.49||||0.9157|TWO_SIDED|95.0|-8.8|9.8|||Chi-squared||The 95% CI for the difference in response rates was estimated using the Hauck-Anderson method.|||9.8|-8.8|0.9157
72527728|NCT01200758|144586271|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.0|||||TWO_SIDED|95.0|0.66|1.51||||||||1.51|0.66|
72527729|NCT01200758|144586272|SUPERIORITY_OR_OTHER||Difference in response rates|-7.28||||0.1715|TWO_SIDED|95.0|-18.0|3.5|||Chi-squared||The 95% CI for the difference in response rates was estimated using the Hauck-Anderson method.|||3.5|-18.0|0.1715
72527730|NCT01200758|144586272|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.8|||||TWO_SIDED|95.0|0.52|1.22||||||||1.22|0.52|
72527731|NCT01200758|144586273|SUPERIORITY_OR_OTHER||Difference in response rates|-0.18||||0.9671|TWO_SIDED|95.0|-9.2|8.8|||Chi-squared||The 95% CI for the difference in response rates was estimated using the Hauck-Anderson method.|||8.8|-9.2|0.9671
72527732|NCT01200758|144586273|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.99|||||TWO_SIDED|95.0|0.6|1.64||||||||1.64|0.60|
72527733|NCT01200758|144586275|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.9||||0.5526|TWO_SIDED|95.0|0.64|1.26|||Wald test|||||1.26|0.64|0.5526
72527734|NCT01200758|144586277|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.98||||0.9115|TWO_SIDED|95.0|0.71|1.36|||Wald test|||||1.36|0.71|0.9115
72527735|NCT01200758|144586280|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.38|||||TWO_SIDED|90.0|1.24|1.53||||||The ratio of observed rituximab serum was determined as AUC SC/AUC IV during Cycle 7 of induction treatment.||1.53|1.24|
72527736|NCT01200758|144586281|SUPERIORITY_OR_OTHER||Geometric mean ratio|0.941|||||TWO_SIDED|95.0|0.872|1.015||||||||1.015|0.872|
72527737|NCT01795716|144586299|NON_INFERIORITY_OR_EQUIVALENCE|The 90%CIs of the test/reference ratios for AUC0-∞ and Cmax were determined. Log-transformed data were used in the analysis. Following international guidelines (including those of the SFDA), the test and reference for mutations were considered bioequivalent if the 90% CIs of the test/reference ratios of AUC was within range of 0.80 to 1.25 and Cmax was within 0.70 to 1.43.|||||<|0.05|TWO_SIDED||||||ANOVA|||The 90% confidence intervals of the test/reference ratios for AUC0-∞ and Cmax were determined. Log-transformed data were used in the analysis. Following international guidelines (including those of the SFDA), the test and reference for mutations were considered bioequivalent if the 90% CIs of the test/reference ratios of AUC was within range of 0.80 to 1.25 and Cmax was within 0.70 to 1.43.||||<0.05
72527738|NCT03525613|144586300|SUPERIORITY||LS Mean Difference|-0.4114||||0.0004|TWO_SIDED|95.0|-0.6397|-0.1831|||MMRM model|||Model included treatment + baseline GA lesion area (\<7.5 mm\^2 or ≥7.5 mm\^2) + analysis visit + presence of choroidal neovascularization (CNV) in the fellow eye (yes or no) + analysis visit × treatment + baseline GA lesion area × analysis visit.||-0.1831|-0.6397|0.0004
72527739|NCT03525613|144586300|SUPERIORITY||LS Mean Difference|-0.318||||0.0055|TWO_SIDED|95.0|-0.5423|-0.0937|||MMRM model|||Model included treatment + baseline GA lesion area (\<7.5 mm\^2 or ≥7.5 mm\^2) + analysis visit + presence of CNV in the fellow eye (yes or no) + analysis visit × treatment + baseline GA lesion area × analysis visit.||-0.0937|-0.5423|0.0055
72527740|NCT03525613|144586301|SUPERIORITY||LS Mean Difference|-0.9015|||<|0.0001|TWO_SIDED|95.0|-1.3026|-0.5004|||MMRM model|||Model included treatment + baseline GA lesion area (\<7.5 mm\^2 or ≥7.5 mm\^2) + analysis visit + baseline presence of CNV in the fellow eye (yes or no) + analysis visit × treatment + baseline GA lesion area (\<7.5 mm\^2 or ≥7.5 mm\^2) × analysis visit.||-0.5004|-1.3026|<0.0001
72527741|NCT03525613|144586301|SUPERIORITY||LS Mean Difference|-0.7426||||0.0002|TWO_SIDED|95.0|-1.1282|-0.357|||MMRM model|||Model included treatment + baseline GA lesion area (\<7.5 mm\^2 or ≥7.5 mm\^2) + analysis visit + baseline presence of CNV in the fellow eye (yes or no) + analysis visit × treatment + baseline GA lesion area (\<7.5 mm\^2 or ≥7.5 mm\^2) × analysis visit.||-0.3570|-1.1282|0.0002
72527742|NCT03525613|144586302|SUPERIORITY|Baseline GA lesion area x Time (continuous) + Baseline GA lesion area x Time Spline at Month 6 (continuous) + Baseline GA lesion area x Time Spline at Month 12 (continuous) + Baseline GA lesion area x Time Spline at Month 18 (continuous). A heterogeneous autoregressive covariance matrix was used to model within-subject errors.|Mean Difference|-0.2234||||0.0007|TWO_SIDED|95.0|-0.3522|-0.0946|||MMRM model|||Estimates for Baseline to Month 6: Model included Treatment + Baseline GA lesion area (\< 7.5 mm\^2 or \>= 7.5 mm\^2) + Time (continuous) + Time Spline at Month 6 (continuous) + Time Spline at Month 12 (continuous) + Time Spline at Month 18 (continuous) + Presence of CNV in the fellow eye (Yes or No) + Time (continuous) x Treatment + Time Spline at Month 6 (continuous) x Treatment + Time Spline at Month 12 (continuous) x Treatment + Time Spline at Month 18 (continuous) x Treatment +||-0.0946|-0.3522|0.0007
72527743|NCT03525613|144586302|SUPERIORITY|Baseline GA lesion area x Time (continuous) + Baseline GA lesion area x Time Spline at Month 6 (continuous) + Baseline GA lesion area x Time Spline at Month 12 (continuous) + Baseline GA lesion area x Time Spline at Month 18 (continuous). A heterogeneous autoregressive covariance matrix was used to model within-subject errors.|Mean Difference|-0.1618||||0.0116|TWO_SIDED|95.0|-0.2874|-0.0361|||MMRM model|||Estimates for Baseline to Month 6: Model included Treatment + Baseline GA lesion area (\< 7.5 mm\^2 or \>= 7.5 mm\^2) + Time (continuous) + Time Spline at Month 6 (continuous) + Time Spline at Month 12 (continuous) + Time Spline at Month 18 (continuous) + Presence of CNV in the fellow eye (Yes or No) + Time (continuous) x Treatment + Time Spline at Month 6 (continuous) x Treatment + Time Spline at Month 12 (continuous) x Treatment + Time Spline at Month 18 (continuous) x Treatment +||-0.0361|-0.2874|0.0116
72527744|NCT03525613|144586302|SUPERIORITY|Baseline GA lesion area x Time (continuous) + Baseline GA lesion area x Time Spline at Month 6 (continuous) + Baseline GA lesion area x Time Spline at Month 12 (continuous) + Baseline GA lesion area x Time Spline at Month 18 (continuous). A heterogeneous autoregressive covariance matrix was used to model within-subject errors.|Mean Difference|-0.1862||||0.0181|TWO_SIDED|95.0|-0.3406|-0.0318|||MMRM model|||Estimates for Month 6 to Month 12: Model included Treatment + Baseline GA lesion area (\< 7.5 mm\^2 or \>= 7.5 mm\^2) + Time (continuous) + Time Spline at Month 6 (continuous) + Time Spline at Month 12 (continuous) + Time Spline at Month 18 (continuous) + Presence of CNV in the fellow eye (Yes or No) + Time (continuous) x Treatment + Time Spline at Month 6 (continuous) x Treatment + Time Spline at Month 12 (continuous) x Treatment + Time Spline at Month 18 (continuous) x Treatment +||-0.0318|-0.3406|0.0181
72527745|NCT03525613|144586302|SUPERIORITY|Baseline GA lesion area x Time (continuous) + Baseline GA lesion area x Time Spline at Month 6 (continuous) + Baseline GA lesion area x Time Spline at Month 12 (continuous) + Baseline GA lesion area x Time Spline at Month 18 (continuous). A heterogeneous autoregressive covariance matrix was used to model within-subject errors.|Mean Difference|-0.1526||||0.0467|TWO_SIDED|95.0|-0.303|-0.0023|||MMRM model|||Estimates for Month 6 to Month 12: Model included Treatment + Baseline GA lesion area (\< 7.5 mm\^2 or \>= 7.5 mm\^2) + Time (continuous) + Time Spline at Month 6 (continuous) + Time Spline at Month 12 (continuous) + Time Spline at Month 18 (continuous) + Presence of CNV in the fellow eye (Yes or No) + Time (continuous) x Treatment + Time Spline at Month 6 (continuous) x Treatment + Time Spline at Month 12 (continuous) x Treatment + Time Spline at Month 18 (continuous) x Treatment +||-0.0023|-0.3030|0.0467
72527746|NCT03525613|144586302|SUPERIORITY|Baseline GA lesion area x Time (continuous) + Baseline GA lesion area x Time Spline at Month 6 (continuous) + Baseline GA lesion area x Time Spline at Month 12 (continuous) + Baseline GA lesion area x Time Spline at Month 18 (continuous). A heterogeneous autoregressive covariance matrix was used to model within-subject errors.|Mean Difference|-0.2265||||0.0019|TWO_SIDED|95.0|-0.3696|-0.0834|||MMRM model|||Estimates for Month 12 to Month 18: Model included Treatment + Baseline GA lesion area (\< 7.5 mm\^2 or \>= 7.5 mm\^2) + Time (continuous) + Time Spline at Month 6 (continuous) + Time Spline at Month 12 (continuous) + Time Spline at Month 18 (continuous) + Presence of CNV in the fellow eye (Yes or No) + Time (continuous) x Treatment + Time Spline at Month 6 (continuous) x Treatment + Time Spline at Month 12 (continuous) x Treatment + Time Spline at Month 18 (continuous) x Treatment +||-0.0834|-0.3696|0.0019
72527747|NCT03525613|144586302|SUPERIORITY|Baseline GA lesion area x Time (continuous) + Baseline GA lesion area x Time Spline at Month 6 (continuous) + Baseline GA lesion area x Time Spline at Month 12 (continuous) + Baseline GA lesion area x Time Spline at Month 18 (continuous). A heterogeneous autoregressive covariance matrix was used to model within-subject errors.|Mean Difference|-0.1586||||0.0288|TWO_SIDED|95.0|-0.3009|-0.0164|||MMRM model|||Estimates for Month 12 to Month 18: Model included Treatment + Baseline GA lesion area (\< 7.5 mm\^2 or \>= 7.5 mm\^2) + Time (continuous) + Time Spline at Month 6 (continuous) + Time Spline at Month 12 (continuous) + Time Spline at Month 18 (continuous) + Presence of CNV in the fellow eye (Yes or No) + Time (continuous) x Treatment + Time Spline at Month 6 (continuous) x Treatment + Time Spline at Month 12 (continuous) x Treatment + Time Spline at Month 18 (continuous) x Treatment +||-0.0164|-0.3009|0.0288
72625334|NCT01098747|144780088|SUPERIORITY_OR_OTHER||Difference in proportion|-6.8||||0.28|TWO_SIDED|95.0|-19.24|5.65||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||4 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||5.65|-19.24|0.280
72625335|NCT01098747|144780088|SUPERIORITY_OR_OTHER||Difference in proportion|48.53|||<|0.001|TWO_SIDED|95.0|36.29|60.77||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||5 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||60.77|36.29|<0.001
72571539|NCT01394952|144671732|SUPERIORITY|"Superiority was declared if the upper limit of the 2-sided 95.33% confidence interval (CI) of the hazard ratio was below 1.0 (after adjustment for the interim analysis).~Once superiority was achieved for the primary endpoint, multiplicity adjustments using the graphical approach were performed for secondary efficacy endpoints in order to control the overall Type I error rate at a 2-sided alpha level of 0.0467."|Hazard Ratio (HR)|0.88||||0.026|TWO_SIDED|95.33|0.79|0.99|||Regression, Cox|||Primary CV endpoint||0.99|0.79|0.026
72571540|NCT01394952|144671733|SUPERIORITY|Multiplicity adjustments using the graphical approach were performed for secondary efficacy endpoints in order to control the overall Type I error rate at a 2-sided alpha level of 0.0467.|Hazard Ratio (HR)|0.91||||0.211|TWO_SIDED|95.0|0.78|1.06|||Regression, Cox|||Death from CV causes||1.06|0.78|0.211
72571541|NCT01394952|144671733|SUPERIORITY|Multiplicity adjustments using the graphical approach were performed for secondary efficacy endpoints in order to control the overall Type I error rate at a 2-sided alpha level of 0.0467.|Hazard Ratio (HR)|0.96||||0.652|TWO_SIDED|95.0|0.79|1.16|||Regression, Cox|||Nonfatal MI||1.16|0.79|0.652
72407297|NCT01573624|144323022|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|18.6|||<|0.001|TWO_SIDED|95.0|12.1|25.1|||Mixed Models Analysis|||No pairwise comparisons between doses of FF + UMEC and FF alone were done unless overall F-test for treatment effect was statistically significant at 5% level. Multiplicity across these comparisons was controlled using a step-down closed testing procedure, whereby statistical comparison of the highest dose of FF + UMEC and FF alone was initially performed, and subsequent comparisons at lower doses continued in a step-down manner if preceding comparison was statistically significant at 5% level.||25.1|12.1|<0.001
72571542|NCT01394952|144671733|SUPERIORITY|Multiplicity adjustments using the graphical approach were performed for secondary efficacy endpoints in order to control the overall Type I error rate at a 2-sided alpha level of 0.0467.|Hazard Ratio (HR)|0.76||||0.017|TWO_SIDED|95.0|0.61|0.95|||Regression, Cox|||Nonfatal stroke||0.95|0.61|0.017
72571543|NCT01394952|144671734|SUPERIORITY|Multiplicity adjustments using the graphical approach were performed for secondary efficacy endpoints in order to control the overall Type I error rate at a 2-sided alpha level of 0.0467.|Hazard Ratio (HR)|0.9||||0.067|TWO_SIDED|95.0|0.8|1.01|||Regression, Cox|||Time to all cause mortality||1.01|0.80|0.067
72625336|NCT01098747|144780088|SUPERIORITY_OR_OTHER||Difference in proportion|-8.01||||0.202|TWO_SIDED|95.0|-20.44|4.41||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||5 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||4.41|-20.44|0.202
72571544|NCT01394952|144671735|SUPERIORITY|Multiplicity adjustments using the graphical approach were performed for secondary efficacy endpoints in order to control the overall Type I error rate at a 2-sided alpha level of 0.0467.|Hazard Ratio (HR)|0.86|||<|0.001|TWO_SIDED|95.0|0.79|0.93|||Regression, Cox|||microvascular endpoint||0.93|0.79|<0.001
72571545|NCT01394952|144671736|SUPERIORITY|Multiplicity adjustments using the graphical approach were performed for secondary efficacy endpoints in order to control the overall Type I error rate at a 2-sided alpha level of 0.0467.|Hazard Ratio (HR)|0.93||||0.456|TWO_SIDED|95.0|0.77|1.12|||Regression, Cox|||Heart failure requiring hospitalization or an urgent heart failure clinic visit||1.12|0.77|0.456
72571546|NCT01394952|144671737|SUPERIORITY|Multiplicity adjustments using the graphical approach were performed for secondary efficacy endpoints in order to control the overall Type I error rate at a 2-sided alpha level of 0.0467.|Hazard Ratio (HR)|1.14||||0.413|TWO_SIDED|95.0|0.84|1.54|||Regression, Cox|||Hospitalization for unstable angina||1.54|0.84|0.413
72571547|NCT02283983|144671738|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
72571548|NCT03276221|144671774|SUPERIORITY||Slope|-0.19|STANDARD_ERROR_OF_MEAN|0.15||0.215|TWO_SIDED|||||The p-value was adjusted for multiple comparisons by the Bonferroni correction across outcomes for the paired associates learning module. The a priori threshold for statistical significance was 0.025.|Mixed Models Analysis|Estimates were obtained using generalized estimating equations (GEE) with robust standard errors obtained by the sandwich estimator.|The estimate is the mean difference in the log probability of making an error for the abstinence group above and beyond the monitoring group (positive values indicate higher error commission for the abstinence group).|The mean difference in scale scores between the abstinence and monitoring groups was estimated via a binomial model with a dummy-coded contrast (0 for monitoring, 1 for abstinence). The model adjusted for change at weeks 2, 3, and 4 of the study, and for a subject's scale scores at baseline.||||0.215
72571549|NCT03276221|144671775|SUPERIORITY||Slope|0.1|STANDARD_ERROR_OF_MEAN|0.14||0.495|TWO_SIDED|||||The p-value was adjusted for multiple comparisons by the Bonferroni correction across outcomes for the paired associates learning module. The a priori threshold for statistical significance was 0.025.|Mixed Models Analysis|Estimates were obtained using generalized estimating equations (GEE) with robust standard errors obtained by the sandwich estimator.|The estimate is the mean difference in the log probability of picking the correct box for the abstinence group above and beyond the monitoring group (positive values indicate better memory performance for the abstinence group).|The mean difference in scale scores between the abstinence and monitoring groups was estimated via a binomial model with a dummy-coded contrast (0 for monitoring, 1 for abstinence). The model adjusted for change at weeks 2, 3, and 4 of the study, and for a subject's scale scores at baseline.||||0.495
72571550|NCT03276221|144671776|SUPERIORITY||Slope|0.28|STANDARD_ERROR_OF_MEAN|0.14||0.05|TWO_SIDED|||||The p-value was adjusted for multiple comparisons by the Bonferroni correction across outcomes for the spatial span module. The a priori threshold for statistical significance was 0.025.|Mixed Models Analysis|Estimates were obtained using generalized estimating equations (GEE) with robust standard errors obtained by the sandwich estimator.|The estimate is the mean difference in the log probability of reaching a longer span for the abstinence group above and beyond the monitoring group (positive values indicate higher span lengths for the abstinence group).|The mean difference in scale scores between the abstinence and monitoring groups was estimated via a binomial model with a dummy-coded contrast (0 for monitoring, 1 for abstinence). The model adjusted for change at weeks 2, 3, and 4 of the study, and for a subject's scale scores at baseline.||||0.050
72527748|NCT03525613|144586302|SUPERIORITY|Baseline GA lesion area x Time (continuous) + Baseline GA lesion area x Time Spline at Month 6 (continuous) + Baseline GA lesion area x Time Spline at Month 12 (continuous) + Baseline GA lesion area x Time Spline at Month 18 (continuous). A heterogeneous autoregressive covariance matrix was used to model within-subject errors.|Mean Difference|-0.2341||||0.008|TWO_SIDED|95.0|-0.4071|-0.0611|||MMRM model|||Estimates for Month 18 to Month 24: Model included Treatment + Baseline GA lesion area (\< 7.5 mm\^2 or \>= 7.5 mm\^2) + Time (continuous) + Time Spline at Month 6 (continuous) + Time Spline at Month 12 (continuous) + Time Spline at Month 18 (continuous) + Presence of CNV in the fellow eye (Yes or No) + Time (continuous) x Treatment + Time Spline at Month 6 (continuous) x Treatment + Time Spline at Month 12 (continuous) x Treatment + Time Spline at Month 18 (continuous) x Treatment +||-0.0611|-0.4071|0.0080
72527749|NCT03525613|144586302|SUPERIORITY|Baseline GA lesion area x Time (continuous) + Baseline GA lesion area x Time Spline at Month 6 (continuous) + Baseline GA lesion area x Time Spline at Month 12 (continuous) + Baseline GA lesion area x Time Spline at Month 18 (continuous). A heterogeneous autoregressive covariance matrix was used to model within-subject errors.|Mean Difference|-0.2459||||0.0007|TWO_SIDED|95.0|-0.3886|-0.1031|||MMRM model|||Estimates for Month 18 to Month 24: Model included Treatment + Baseline GA lesion area (\< 7.5 mm\^2 or \>= 7.5 mm\^2) + Time (continuous) + Time Spline at Month 6 (continuous) + Time Spline at Month 12 (continuous) + Time Spline at Month 18 (continuous) + Presence of CNV in the fellow eye (Yes or No) + Time (continuous) x Treatment + Time Spline at Month 6 (continuous) x Treatment + Time Spline at Month 12 (continuous) x Treatment + Time Spline at Month 18 (continuous) x Treatment +||-0.1031|-0.3886|0.0007
72527750|NCT03525613|144586302|SUPERIORITY|Baseline GA lesion area x Time (continuous) + Baseline GA lesion area x Time Spline at Month 6 (continuous) + Baseline GA lesion area x Time Spline at Month 12 (continuous) + Baseline GA lesion area x Time Spline at Month 18 (continuous). A heterogeneous autoregressive covariance matrix was used to model within-subject errors.|Mean Difference|-0.8702|||<|0.0001|TWO_SIDED|95.0|-1.274|-0.4664|||MMRM model|||Estimates for Baseline to Month 24: Model included Treatment + Baseline GA lesion area (\< 7.5 mm\^2 or \>= 7.5 mm\^2) + Time (continuous) + Time Spline at Month 6 (continuous) + Time Spline at Month 12 (continuous) + Time Spline at Month 18 (continuous) + Presence of CNV in the fellow eye (Yes or No) + Time (continuous) x Treatment + Time Spline at Month 6 (continuous) x Treatment + Time Spline at Month 12 (continuous) x Treatment + Time Spline at Month 18 (continuous) x Treatment +||-0.4664|-1.2740|<0.0001
72527751|NCT03525613|144586302|SUPERIORITY|Baseline GA lesion area x Time (continuous) + Baseline GA lesion area x Time Spline at Month 6 (continuous) + Baseline GA lesion area x Time Spline at Month 12 (continuous) + Baseline GA lesion area x Time Spline at Month 18 (continuous). A heterogeneous autoregressive covariance matrix was used to model within-subject errors.|Mean Difference|-0.7189||||0.0003|TWO_SIDED|95.0|-1.1039|-0.3339|||MMRM model|||Estimates for Baseline to Month 24: Model included Treatment + Baseline GA lesion area (\< 7.5 mm\^2 or \>= 7.5 mm\^2) + Time (continuous) + Time Spline at Month 6 (continuous) + Time Spline at Month 12 (continuous) + Time Spline at Month 18 (continuous) + Presence of CNV in the fellow eye (Yes or No) + Time (continuous) x Treatment + Time Spline at Month 6 (continuous) x Treatment + Time Spline at Month 12 (continuous) x Treatment + Time Spline at Month 18 (continuous) x Treatment +||-0.3339|-1.1039|0.0003
72527752|NCT02584660|144586316|SUPERIORITY||Mean difference|-1.202|||<|0.0001|TWO_SIDED|95.0|-1.73|-0.674|||t-test|||||-0.674|-1.730|<.0001
72527753|NCT00461552|144586322|SUPERIORITY|||||||0.84||||||Treatment time month interaction|Mixed Models Analysis|||||||0.84
72527754|NCT00461552|144586323|OTHER|||||||0.4||||||Treatment time month interaction|Mixed Models Analysis|||||||0.4
72527755|NCT00374452|144586324|OTHER||||||>|0.1|||||||Mixed Models Analysis|||We compared the mean percentages of events per clinician between study arms, using mixed model regression adjusting for medical center, clinic type (community-based clinic vs not), clinician discipline (MD vs non-MD), presence of pharmacist in the clinic, and mean age of clinician's panels of patients as fixed effects, and clinic as a random effect to account for clustering of clinicians within clinics.||||>0.1
72527756|NCT01401101|144586339|SUPERIORITY_OR_OTHER|||||||0.97|TWO_SIDED|95.0||||Jointly modeled outcomes at the 3 waves by time, condition, and timeXcondition, to allow for different effects at 6 and 12 mos; controlled for interview mode (phone vs. in-person); used random effects to account for correlations wi/in site \& patient.|Regression, Linear|||Intent-to-treat (ITT) analysis using the linear mixed-method model to estimate the difference between the PCM and TAU conditions||||0.97
72625337|NCT01098747|144780088|SUPERIORITY_OR_OTHER||Difference in proportion|48.53|||<|0.001|TWO_SIDED|95.0|36.29|60.77||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||6 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||60.77|36.29|<0.001
72527757|NCT01401101|144586340|SUPERIORITY_OR_OTHER|||||||0.54|TWO_SIDED|95.0|||||Regression, Linear|||Intent-to-treat (ITT) analysis using the linear mixed-method model to estimate the difference between the PCM and TAU conditions||||0.54
72527758|NCT01401101|144586341|SUPERIORITY_OR_OTHER|||||||0.33||||||Jointly modeled outcomes at the 3 waves by time, condition, and timeXcondition, to allow for different effects at 6 and 12 mos; controlled for interview mode (phone vs. in-person); using random effects to control for correlations w/in site \& patient.|Regression, Linear|||Intent-to-treat (ITT) analysis using the linear mixed-method model to estimate the difference between the PCM and TAU conditions||||0.33
72527759|NCT03198884|144586344|OTHER|The percent of patients with an RNA \<50 copies/mL at each time point was analyzed using McNemar's test following the guidelines of the Snapshot algorithm. Missing RNA data was considered a treatment failure. Change in mean serum creatinine from baseline was analyzed using Wilcoxon signed rank test.|||||<|0.05|||||||McNemar||||Change in mean CD4+ cell counts from baseline was analyzed using a paired t-test. All analyses used a p-value of less than or equal to 0.05 as significant. Statistical analyses were performed using R software, version 3.4.3.|||<0.05
72527760|NCT03198884|144586345|OTHER||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
72527761|NCT00537810|144586351|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6|||||||Chi-squared|df=3||Post-treatment||||0.60
72527762|NCT00537810|144586351|SUPERIORITY_OR_OTHER_LEGACY|||||||0.13|||||||Chi-squared|df=3||6 month follow up||||0.13
72527763|NCT00537810|144586351|SUPERIORITY_OR_OTHER_LEGACY|||||||0.29|||||||Chi-squared|df=3||12 month follow up||||0.29
72625338|NCT01098747|144780088|SUPERIORITY_OR_OTHER||Difference in proportion|-8.61||||0.17|TWO_SIDED|95.0|-21.02|3.8||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||6 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||3.80|-21.02|0.170
72527764|NCT03860181|144586368|EQUIVALENCE|The statistical significance's p-value was set at 0.05. For Surgeon 1's differences, they were calculated as patient POSAS score - surgeon POSAS score, with a negative difference signifying that the patients thought more highly of the scars than the physicians since lower POSAS scores are more favorable.||||||0.896|||||||Wilcoxon (Mann-Whitney)|Mann-Whitney U = 215||||||0.896
72527765|NCT03860181|144586368|EQUIVALENCE|The statistical significance's p-value was set at 0.05. For Surgeon 2's differences, they were calculated as patient POSAS score - surgeon POSAS score, with a negative difference signifying that the patients thought more highly of the scars than the physicians since lower POSAS scores are more favorable.||||||0.612|||||||Wilcoxon (Mann-Whitney)|Mann-Whitney U = 210||||||0.612
72527766|NCT01385098|144586380|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||< 0.001
72527767|NCT01385098|144586381|SUPERIORITY_OR_OTHER|||||||0.013||||||Change from preoperative to 12 weeks|Wilcoxon (Mann-Whitney)|||||||0.013
72527768|NCT01385098|144586381|SUPERIORITY_OR_OTHER|||||||0.01||||||Change from preoperative to 12 weeks|Wilcoxon (Mann-Whitney)|||||||0.010
72527769|NCT02253173|144586389|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
72527770|NCT02253173|144586389|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
72527771|NCT02253173|144586389|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
72527772|NCT02253173|144586390|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
72527773|NCT02253173|144586390|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
72527774|NCT02253173|144586390|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
72527775|NCT02253173|144586391|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
72527776|NCT02253173|144586391|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
72527777|NCT02253173|144586391|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
72527778|NCT02253173|144586392|SUPERIORITY_OR_OTHER|||||||0.0149|||||||Mixed Models Analysis|||||||0.0149
72527779|NCT02253173|144586392|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
72527780|NCT02253173|144586392|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
72527781|NCT02253173|144586393|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
72527782|NCT02253173|144586393|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
72527783|NCT02253173|144586393|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
72527784|NCT02253173|144586394|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
72527785|NCT02253173|144586394|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
72527786|NCT02253173|144586394|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
72527787|NCT02253173|144586395|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
72527788|NCT02253173|144586395|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
72527789|NCT02253173|144586395|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
72527790|NCT02253173|144586396|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
72527791|NCT02253173|144586396|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
72527792|NCT02253173|144586396|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
72527793|NCT02253173|144586397|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
72527794|NCT02253173|144586397|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
72527795|NCT02253173|144586397|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
72527796|NCT02253173|144586398|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
72527797|NCT02253173|144586398|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
72527798|NCT02253173|144586398|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
72527799|NCT02253173|144586399|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
72527800|NCT02253173|144586399|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
72527801|NCT02253173|144586399|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
72527802|NCT02253173|144586400|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
72527803|NCT02253173|144586400|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
72527804|NCT02253173|144586400|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
72527805|NCT02253173|144586401|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
72527806|NCT02253173|144586401|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
72527807|NCT02253173|144586401|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
72527808|NCT02253173|144586402|SUPERIORITY_OR_OTHER|||||||0.026|||||||Mixed Models Analysis|||||||0.0260
72527809|NCT02253173|144586402|SUPERIORITY_OR_OTHER|||||||0.0019|||||||Mixed Models Analysis|||||||0.0019
72527810|NCT02253173|144586402|SUPERIORITY_OR_OTHER|||||||0.0105|||||||Mixed Models Analysis|||||||0.0105
72527811|NCT02253173|144586403|SUPERIORITY_OR_OTHER|||||||0.0069|||||||Mixed Models Analysis|||||||0.0069
72527812|NCT02253173|144586403|SUPERIORITY_OR_OTHER|||||||0.0009|||||||Mixed Models Analysis|||||||0.0009
72527813|NCT02253173|144586403|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
72527814|NCT02253173|144586404|SUPERIORITY_OR_OTHER|||||||0.0003|||||||Mixed Models Analysis|||||||0.0003
72527815|NCT02253173|144586404|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
72527816|NCT02253173|144586404|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
72527817|NCT02253173|144586405|SUPERIORITY_OR_OTHER|||||||0.1269|||||||Mixed Models Analysis|||||||0.1269
72407298|NCT01573624|144323022|SUPERIORITY_OR_OTHER||Mean Difference (Net)|22.9|||<|0.001|TWO_SIDED|95.0|16.5|29.4|||Mixed Models Analysis|||No pairwise comparisons between doses of FF + UMEC and FF alone were done unless overall F-test for treatment effect was statistically significant at 5% level. Multiplicity across these comparisons was controlled using a step-down closed testing procedure, whereby statistical comparison of the highest dose of FF + UMEC and FF alone was initially performed, and subsequent comparisons at lower doses continued in a step-down manner if preceding comparison was statistically significant at 5% level.||29.4|16.5|<0.001
72407299|NCT01573624|144323022|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|22.0|||<|0.001|TWO_SIDED|95.0|15.5|28.4|||Mixed Models Analysis|||No pairwise comparisons between doses of FF + UMEC and FF alone were done unless overall F-test for treatment effect was statistically significant at 5% level. Multiplicity across these comparisons was controlled using a step-down closed testing procedure, whereby statistical comparison of the highest dose of FF + UMEC and FF alone was initially performed, and subsequent comparisons at lower doses continued in a step-down manner if preceding comparison was statistically significant at 5% level.||28.4|15.5|<0.001
72625339|NCT01098747|144780088|SUPERIORITY_OR_OTHER||Difference in proportion|48.53|||<|0.001|TWO_SIDED|95.0|36.29|60.77||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||7 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||60.77|36.29|<0.001
72407300|NCT01573624|144323022|SUPERIORITY_OR_OTHER||Mean Difference (Net)|27.0|||<|0.001|TWO_SIDED|95.0|20.6|33.5|||Mixed Models Analysis|||||33.5|20.6|<0.001
72407301|NCT01573624|144323022|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-11.2|||<|0.001|TWO_SIDED|95.0|-17.6|-4.7|||Mixed Models Analysis|||No adjustments were made for comparisons between doses of FF + UMEC and FF + VI.||-4.7|-17.6|<0.001
72527818|NCT02253173|144586405|SUPERIORITY_OR_OTHER|||||||0.0019|||||||Mixed Models Analysis|||||||0.0019
72527819|NCT02253173|144586405|SUPERIORITY_OR_OTHER|||||||0.0082|||||||Mixed Models Analysis|||||||0.0082
72527820|NCT02253173|144586406|SUPERIORITY_OR_OTHER|||||||0.0094|||||||Mixed Models Analysis|||||||0.0094
72527821|NCT02253173|144586406|SUPERIORITY_OR_OTHER|||||||0.0001|||||||Mixed Models Analysis|||||||0.0001
72527822|NCT02253173|144586406|SUPERIORITY_OR_OTHER|||||||0.0005|||||||Mixed Models Analysis|||||||0.0005
72527823|NCT02253173|144586407|SUPERIORITY_OR_OTHER|||||||0.0128|||||||Mixed Models Analysis|||||||0.0128
72527824|NCT02253173|144586407|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
72527825|NCT02253173|144586407|SUPERIORITY_OR_OTHER|||||||0.0008|||||||Mixed Models Analysis|||||||0.0008
72527826|NCT02253173|144586408|SUPERIORITY_OR_OTHER|||||||0.0014|||||||Mixed Models Analysis|||||||0.0014
72407302|NCT01573624|144323022|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-9.6||||0.004|TWO_SIDED|95.0|-16.1|-3.1|||Mixed Models Analysis|||No adjustments were made for comparisons between doses of FF + UMEC and FF + VI.||-3.1|-16.1|0.004
72407303|NCT01573624|144323022|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-8.4||||0.012|TWO_SIDED|95.0|-14.9|-1.9|||Mixed Models Analysis|||No adjustments were made for comparisons between doses of FF + UMEC and FF + VI.||-1.9|-14.9|0.012
72407304|NCT01573624|144323022|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.1||||0.209|TWO_SIDED|95.0|-10.6|2.3|||Mixed Models Analysis|||No adjustments were made for comparisons between doses of FF + UMEC and FF + VI.||2.3|-10.6|0.209
72407305|NCT01573624|144323022|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.1||||0.124|TWO_SIDED|95.0|-11.6|1.4|||Mixed Models Analysis|||No adjustments were made for comparisons between doses of FF + UMEC and FF + VI.||1.4|-11.6|0.124
72407306|NCT01573624|144323023|SUPERIORITY_OR_OTHER||Mean Difference (Net)|16.2|||<|0.001|TWO_SIDED|95.0|9.5|22.9|||Mixed Models Analysis|||No pairwise comparisons between doses of FF + UMEC and FF alone were done unless overall F-test for treatment effect was statistically significant at 5% level. Multiplicity across these comparisons was controlled using a step-down closed testing procedure, whereby statistical comparison of the highest dose of FF + UMEC and FF alone was initially performed, and subsequent comparisons at lower doses continued in a step-down manner if preceding comparison was statistically significant at 5% level.||22.9|9.5|<0.001
72527827|NCT02253173|144586408|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
72527828|NCT02253173|144586408|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
72527829|NCT02253173|144586409|SUPERIORITY_OR_OTHER|||||||0.9616|||||||Mixed Models Analysis|||||||0.9616
72527830|NCT02253173|144586409|SUPERIORITY_OR_OTHER|||||||0.2439|||||||Mixed Models Analysis|||||||0.2439
72527831|NCT02253173|144586409|SUPERIORITY_OR_OTHER|||||||0.6518|||||||Mixed Models Analysis|||||||0.6518
72527832|NCT02253173|144586410|SUPERIORITY_OR_OTHER|||||||0.7829|||||||Mixed Models Analysis|||||||0.7829
72527833|NCT02253173|144586410|SUPERIORITY_OR_OTHER|||||||0.2328|||||||Mixed Models Analysis|||||||0.2328
72527834|NCT02253173|144586410|SUPERIORITY_OR_OTHER|||||||0.4118|||||||Mixed Models Analysis|||||||0.4118
72527835|NCT02253173|144586411|SUPERIORITY_OR_OTHER|||||||0.0639|||||||Mixed Models Analysis|||||||0.0639
72527836|NCT02253173|144586411|SUPERIORITY_OR_OTHER|||||||0.0356|||||||Mixed Models Analysis|||||||0.0356
72527837|NCT02253173|144586411|SUPERIORITY_OR_OTHER|||||||0.0914|||||||Mixed Models Analysis|||||||0.0914
72527838|NCT02253173|144586412|SUPERIORITY_OR_OTHER|||||||0.0503|||||||Mixed Models Analysis|||||||0.0503
72527839|NCT02253173|144586412|SUPERIORITY_OR_OTHER|||||||0.0055|||||||Mixed Models Analysis|||||||0.0055
72527840|NCT02253173|144586412|SUPERIORITY_OR_OTHER|||||||0.0263|||||||Mixed Models Analysis|||||||0.0263
72527841|NCT02253173|144586413|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
72527842|NCT02253173|144586413|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
72527843|NCT02253173|144586413|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
72527844|NCT02253173|144586414|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
72527845|NCT02253173|144586414|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
72527846|NCT02253173|144586414|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
72527847|NCT02253173|144586415|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
72527848|NCT02253173|144586415|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
72571551|NCT03276221|144671777|SUPERIORITY||Slope|-0.07|STANDARD_ERROR_OF_MEAN|0.12||0.532|TWO_SIDED|||||The p-value was adjusted for multiple comparisons by the Bonferroni correction across outcomes for the spatial span module. The a priori threshold for statistical significance was 0.025.|Mixed Models Analysis|Estimates were obtained using generalized estimating equations (GEE) with robust standard errors obtained by the sandwich estimator.|The estimate is the mean difference in the log probability of reaching a longer span for the abstinence group above and beyond the monitoring group (positive values indicate higher span lengths for the abstinence group).|The mean difference in scale scores between the abstinence and monitoring groups was estimated via a binomial model with a dummy-coded contrast (0 for monitoring, 1 for abstinence). The model adjusted for change at weeks 2, 3, and 4 of the study, and for a subject's scale scores at baseline.||||0.532
72571552|NCT03276221|144671778|SUPERIORITY||Slope|0.09|STANDARD_ERROR_OF_MEAN|0.07||0.226|TWO_SIDED|||||The p-value was adjusted for multiple comparisons by the Bonferroni correction across outcomes for the verbal recognition memory module. The a priori threshold for statistical significance was 0.0125.|Mixed Models Analysis|Estimates were obtained using generalized estimating equations (GEE) with robust standard errors obtained by the sandwich estimator.|The estimate is the mean difference in the log probability of making a correct choice for the abstinence group above and beyond the monitoring group (positive values indicate higher memory performance for the abstinence group).|The mean difference in scale scores between the abstinence and monitoring groups was estimated via a binomial model with a dummy-coded contrast (0 for monitoring, 1 for abstinence). The model adjusted for change at weeks 2, 3, and 4 of the study, and for a subject's scale scores at baseline.||||0.226
72527849|NCT02253173|144586415|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
72571553|NCT03276221|144671779|SUPERIORITY||Slope|0.08|STANDARD_ERROR_OF_MEAN|0.09||0.369|TWO_SIDED|||||The p-value was adjusted for multiple comparisons by the Bonferroni correction across outcomes for the verbal recognition memory module. The a priori threshold for statistical significance was 0.0125.|Mixed Models Analysis|Estimates were obtained using generalized estimating equations (GEE) with robust standard errors obtained by the sandwich estimator.|The estimate is the mean difference in the log probability of making a correct choice for the abstinence group above and beyond the monitoring group (positive values indicate higher memory performance for the abstinence group).|The mean difference in scale scores between the abstinence and monitoring groups was estimated via a binomial model with a dummy-coded contrast (0 for monitoring, 1 for abstinence). The model adjusted for change at weeks 2, 3, and 4 of the study, and for a subject's scale scores at baseline.||||0.369
72527850|NCT02253173|144586416|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
72527851|NCT02253173|144586416|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
72527852|NCT02253173|144586416|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
72527853|NCT02253173|144586417|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
72527854|NCT02253173|144586417|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
72527855|NCT02253173|144586417|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
72527856|NCT02253173|144586418|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
72527857|NCT02253173|144586418|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
72527858|NCT02253173|144586418|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
72527859|NCT02253173|144586419|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
72527860|NCT02253173|144586419|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
72527861|NCT02253173|144586419|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
72527862|NCT02253173|144586420|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
72527863|NCT02253173|144586420|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
72527864|NCT02253173|144586420|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
72527865|NCT02253173|144586421|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
72527866|NCT02253173|144586421|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
72527867|NCT02253173|144586421|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
72527868|NCT02253173|144586422|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
72527869|NCT02253173|144586422|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
72576764|NCT00261443|144680647|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.13||||0.142|TWO_SIDED|95.0|-0.3|0.04||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 16 Comparison||0.04|-0.30|0.142
72576765|NCT00261443|144680647|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.16||||0.092|TWO_SIDED|95.0|-0.35|0.03||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 20 Comparison||0.03|-0.35|0.092
72576766|NCT00261443|144680647|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.2||||0.039|TWO_SIDED|95.0|-0.4|-0.01||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 24 Comparison||-0.01|-0.40|0.039
72527870|NCT02253173|144586422|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
72527871|NCT02253173|144586423|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
72407307|NCT01573624|144323023|SUPERIORITY_OR_OTHER||Mean Difference (Net)|17.2|||<|0.001|TWO_SIDED|95.0|10.5|24.0|||Mixed Models Analysis|||No pairwise comparisons between doses of FF + UMEC and FF alone were done unless overall F-test for treatment effect was statistically significant at 5% level. Multiplicity across these comparisons was controlled using a step-down closed testing procedure, whereby statistical comparison of the highest dose of FF + UMEC and FF alone was initially performed, and subsequent comparisons at lower doses continued in a step-down manner if preceding comparison was statistically significant at 5% level.||24.0|10.5|<0.001
72407308|NCT01573624|144323023|SUPERIORITY_OR_OTHER||Mean Difference (Net)|21.2|||<|0.001|TWO_SIDED|95.0|14.4|28.0|||Mixed Models Analysis|||No pairwise comparisons between doses of FF + UMEC and FF alone were done unless overall F-test for treatment effect was statistically significant at 5% level. Multiplicity across these comparisons was controlled using a step-down closed testing procedure, whereby statistical comparison of the highest dose of FF + UMEC and FF alone was initially performed, and subsequent comparisons at lower doses continued in a step-down manner if preceding comparison was statistically significant at 5% level.||28.0|14.4|<0.001
72407309|NCT01573624|144323023|SUPERIORITY_OR_OTHER||Mean Difference (Net)|28.8|||<|0.001|TWO_SIDED|95.0|22.1|35.5|||Mixed Models Analysis|||No pairwise comparisons between doses of FF + UMEC and FF alone were done unless overall F-test for treatment effect was statistically significant at 5% level. Multiplicity across these comparisons was controlled using a step-down closed testing procedure, whereby statistical comparison of the highest dose of FF + UMEC and FF alone was initially performed, and subsequent comparisons at lower doses continued in a step-down manner if preceding comparison was statistically significant at 5% level.||35.5|22.1|<0.001
72407310|NCT01573624|144323023|SUPERIORITY_OR_OTHER||Mean Difference (Net)|22.9|||<|0.001|TWO_SIDED|95.0|16.2|29.6|||Mixed Models Analysis|||No pairwise comparisons between doses of FF + UMEC and FF alone were done unless overall F-test for treatment effect was statistically significant at 5% level. Multiplicity across these comparisons was controlled using a step-down closed testing procedure, whereby statistical comparison of the highest dose of FF + UMEC and FF alone was initially performed, and subsequent comparisons at lower doses continued in a step-down manner if preceding comparison was statistically significant at 5% level.||29.6|16.2|<0.001
72527872|NCT02253173|144586423|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
72527873|NCT02253173|144586423|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
72527874|NCT02253173|144586424|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
72527875|NCT02253173|144586424|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
72527876|NCT02253173|144586424|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
72527877|NCT02253173|144586425|SUPERIORITY_OR_OTHER|||||||0.0004|||||||Mixed Models Analysis|||||||0.0004
72527878|NCT02253173|144586425|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
72527879|NCT02253173|144586425|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
72527880|NCT02253173|144586426|SUPERIORITY_OR_OTHER|||||||0.0001|||||||Mixed Models Analysis|||||||0.0001
72527881|NCT02253173|144586426|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
72527882|NCT02253173|144586426|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
72527883|NCT02253173|144586427|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
72527884|NCT02253173|144586427|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
72527885|NCT02253173|144586427|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
72527886|NCT02253173|144586428|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
72527887|NCT02253173|144586428|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
72527888|NCT02253173|144586428|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
72527889|NCT02253173|144586429|SUPERIORITY_OR_OTHER|||||||0.9075|||||||ANCOVA|||||||0.9075
72527890|NCT02253173|144586429|SUPERIORITY_OR_OTHER|||||||0.0492|||||||ANCOVA|||||||0.0492
72527891|NCT02253173|144586429|SUPERIORITY_OR_OTHER|||||||0.0019|||||||ANCOVA|||||||0.0019
72527892|NCT02253173|144586430|SUPERIORITY_OR_OTHER|||||||0.9719|||||||ANCOVA|||||||0.9719
72527893|NCT02253173|144586430|SUPERIORITY_OR_OTHER|||||||0.0614|||||||ANCOVA|||||||0.0614
72527894|NCT02253173|144586430|SUPERIORITY_OR_OTHER|||||||0.0085|||||||ANCOVA|||||||0.0085
72527895|NCT02253173|144586431|SUPERIORITY_OR_OTHER|||||||0.9999|||||||ANCOVA|||||||0.9999
72527896|NCT02253173|144586431|SUPERIORITY_OR_OTHER|||||||0.2855|||||||ANCOVA|||||||0.2855
72527897|NCT02253173|144586431|SUPERIORITY_OR_OTHER|||||||0.1189|||||||ANCOVA|||||||0.1189
72527898|NCT02253173|144586432|SUPERIORITY_OR_OTHER|||||||0.4162|||||||ANCOVA|||||||0.4162
72527899|NCT02253173|144586432|SUPERIORITY_OR_OTHER|||||||0.0013|||||||ANCOVA|||||||0.0013
72527900|NCT02253173|144586432|SUPERIORITY_OR_OTHER|||||||0.0003|||||||ANCOVA|||||||0.0003
72527901|NCT02253173|144586433|SUPERIORITY_OR_OTHER|||||||0.9929|||||||ANCOVA|||||||0.9929
72527902|NCT02253173|144586433|SUPERIORITY_OR_OTHER|||||||0.9634|||||||ANCOVA|||||||0.9634
72527903|NCT02253173|144586433|SUPERIORITY_OR_OTHER|||||||0.0898|||||||ANCOVA|||||||0.0898
72527904|NCT02253173|144586434|SUPERIORITY_OR_OTHER|||||||0.5146|||||||ANCOVA|||||||0.5146
72527905|NCT02253173|144586434|SUPERIORITY_OR_OTHER|||||||0.0099|||||||ANCOVA|||||||0.0099
72527906|NCT02253173|144586434|SUPERIORITY_OR_OTHER|||||||0.015|||||||ANCOVA|||||||0.0150
72527907|NCT02253173|144586435|SUPERIORITY_OR_OTHER|||||||0.9039|||||||ANCOVA|||||||0.9039
72527908|NCT02253173|144586435|SUPERIORITY_OR_OTHER|||||||0.3751|||||||ANCOVA|||||||0.3751
72527909|NCT02253173|144586435|SUPERIORITY_OR_OTHER|||||||0.0073|||||||ANCOVA|||||||0.0073
72542595|NCT00361257|144615070|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.071|STANDARD_ERROR_OF_MEAN|0.497||0.89|TWO_SIDED|95.0|0.405|2.837||The p-value was not adjusted for multiple comparisons.|Regression, Logistic|The model was adjusted for the stratification variables and the baseline CNS penetration score.||The null hypothesis was that the proportion of participants who got better at week 24 compared to baseline in the minocycline group was the same as the one in the placebo group.||2.837|0.405|0.890
72407311|NCT01573624|144323023|SUPERIORITY_OR_OTHER||Mean Difference (Net)|26.6|||<|0.001|TWO_SIDED|95.0|19.8|33.4|||Mixed Models Analysis|||||33.4|19.8|<0.001
72407312|NCT01573624|144323023|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-10.3||||0.003|TWO_SIDED|95.0|-17.2|-3.5|||Mixed Models Analysis|||No adjustments were made for comparisons between doses of FF + UMEC and FF + VI.||-3.5|-17.2|0.003
72527910|NCT00410514|144586437|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin was -3 mL/sec for Qmax. Mirabegron was considered non-inferior to placebo for Qmax if the lower limit of the 2-sided 95% confidence interval (CI) for the difference from placebo was greater than -3 mL/sec.|LS Mean Difference|0.4|||||TWO_SIDED|95.0|-0.63|1.42|||ANCOVA||Treatment groups were compared using ANCOVA with pooled center and treatment as factors and the baseline value as a covariate. Centers with less than 12 patients were pooled before the analysis.|The study was designed to show non-inferiority of mirabegron compared to placebo for both primary outcome measures. The comparison between mirabegron 50 mg and placebo was conducted first. If non-inferiority was demonstrated in this comparison, mirabegron 100 mg was compared to placebo. However, if the first comparison did not demonstrate non-inferiority, no further comparison was made. This procedure maintained the overall type I error of one-sided 2.5%.||1.42|-0.63|
72527911|NCT00410514|144586437|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin was -3 mL/sec for Qmax. Mirabegron was considered non-inferior to placebo for Qmax if the lower limit of the 2-sided 95% confidence interval (CI) for the difference from placebo was greater than -3 mL/sec.|LS Mean Difference|0.62|||||TWO_SIDED|95.0|-0.43|1.68|||ANCOVA||Treatment groups were compared using ANCOVA with pooled center and treatment as factors and the baseline value as a covariate. Centers with less than 12 patients were pooled before the analysis.|The study was designed to show non-inferiority of mirabegron compared to placebo for both primary outcome measures. The comparison between mirabegron 50 mg and placebo was conducted first. If non-inferiority was demonstrated in this comparison, mirabegron 100 mg was compared to placebo. However, if the first comparison did not demonstrate non-inferiority, no further comparison was made. This procedure maintained the overall type I error of one-sided 2.5%.||1.68|-0.43|
72527912|NCT00410514|144586439|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin was 15 cmH2O for PdetQmax. Mirabegron was considered non-inferior to placebo for PdetQmax if the lower limit of the 2-sided 95% confidence interval (CI) for the difference from placebo was less than 15 cmH2O.|LS Mean Difference|-5.94|||||TWO_SIDED|95.0|-13.98|2.09|||ANCOVA||Treatment groups were compared using ANCOVA with pooled center and treatment as factors and the baseline value as a covariate. Centers with less than 12 patients were pooled before the analysis.|The study was designed to show non-inferiority of mirabegron compared to placebo for both primary outcome measures. The comparison between mirabegron 50 mg and placebo was conducted first. If non-inferiority was demonstrated in this comparison, mirabegron 100 mg was compared to placebo. However, if the first comparison did not demonstrate non-inferiority, no further comparison was made. This procedure maintained the overall type I error of one-sided 2.5%.||2.09|-13.98|
72527913|NCT00410514|144586439|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin was 15 cmH2O for PdetQmax. Mirabegron was considered non-inferior to placebo for PdetQmax if the lower limit of the 2-sided 95% confidence interval (CI) for the difference from placebo was less than 15 cmH2O.|LS Mean Difference|-1.39|||||TWO_SIDED|95.0|-9.73|6.96|||ANCOVA||Treatment groups were compared using ANCOVA with pooled center and treatment as factors and the baseline value as a covariate. Centers with less than 12 patients were pooled before the analysis.|The study was designed to show non-inferiority of mirabegron compared to placebo for both primary outcome measures. The comparison between mirabegron 50 mg and placebo was conducted first. If non-inferiority was demonstrated in this comparison, mirabegron 100 mg was compared to placebo. However, if the first comparison did not demonstrate non-inferiority, no further comparison was made. This procedure maintained the overall type I error of one-sided 2.5%.||6.96|-9.73|
72527914|NCT00945945|144586458|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.34||||0.105|TWO_SIDED|95.0|-0.07|0.75||P-value for Change from Baseline to Endpoint (BOCF).|ANCOVA|Main Effect Model: Change = Treatment + Pooled Investigator + Baseline (Type III sums of squares).|Least Squares Mean Difference = DLX30-PLA minus PLA-DLX60.|||0.75|-0.07|0.105
72527915|NCT00626327|144586469|NON_INFERIORITY_OR_EQUIVALENCE|The immune response of MenACWY-CRM+MMRV group was considered non-inferior to that of MMRV group if the lower limit of the two-sided 95% CI of the difference in the percentage of subjects with seroconversion for measles was greater than -5%, at 6 weeks after MMRV vaccination.|Difference % (MenACWY-CRM+MMRV-MMRV)|-1.0|||||TWO_SIDED|95.0|-3.4|0.5||||||Non-inferiority of immune response to measles following one dose of MMRV administered concomitantly with MenACWY-CRM as compared to MMRV given alone.||0.5|-3.4|
72527916|NCT00626327|144586469|NON_INFERIORITY_OR_EQUIVALENCE|The immune response of MenACWY-CRM+MMRV group was considered non-inferior to that of MMRV group if the lower limit of the two-sided 95% CI of the difference in the percentage of subjects with seroconversion for mumps was greater than -5%, at 6 weeks after MMRV vaccination.|Difference % (MenACWY-CRM+MMRV - MMRV )|1.0|||||TWO_SIDED|95.0|-1.0|3.7||||||Non-inferiority of immune response to mumps following one dose of MMRV administered concomitantly with MenACWY-CRM as compared to MMRV administered alone.||3.7|-1|
72527917|NCT00626327|144586469|NON_INFERIORITY_OR_EQUIVALENCE|The immune response of MenACWY-CRM+MMRV group was considered non-inferior to that of MMRV group if the lower limit of the two-sided 95% CI of the difference in the percentage of subjects with seroconversion for rubella was greater than -5%, at 6 weeks after MMRV vaccination.|Difference% (MenACWY-CRM+MMRV-MMRV)|-2.0|||||TWO_SIDED|95.0|-4.5|0.8||||||Non-inferiority of immune response to rubella following one dose of MMRV administered concomitantly with MenACWY-CRM as compared to MMRV administered alone.||0.8|-4.5|
72625340|NCT01098747|144780088|SUPERIORITY_OR_OTHER||Difference in proportion|-9.23||||0.14|TWO_SIDED|95.0|-21.62|3.16||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||7 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||3.16|-21.62|0.140
72407313|NCT01573624|144323023|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-9.3||||0.007|TWO_SIDED|95.0|-16.2|-2.5|||Mixed Models Analysis|||No adjustments were made for comparisons between doses of FF + UMEC and FF + VI.||-2.5|-16.2|0.007
72407314|NCT01573624|144323023|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.4||||0.126|TWO_SIDED|95.0|-12.3|1.5|||Mixed Models Analysis|||No adjustments were made for comparisons between doses of FF + UMEC and FF + VI.||1.5|-12.3|0.126
72625341|NCT01098747|144780088|SUPERIORITY_OR_OTHER||Difference in proportion|48.53|||<|0.001|TWO_SIDED|95.0|36.29|60.77||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||8 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||60.77|36.29|<0.001
72527918|NCT00626327|144586469|NON_INFERIORITY_OR_EQUIVALENCE|The immune response of MenACWY-CRM+MMRV group was considered non-inferior to that of MMRV group if the lower limit of the two-sided 95% CI of the difference in the percentage of subjects with seroprotection for varicella was greater than -10%, at 6 weeks after MMRV vaccination.|Difference% (MenACWY-CRM+MMRV-MMRV)|-1.0|||||TWO_SIDED|95.0|-3.9|1.2||||||Non-inferiority of immune response to varicella following one dose of MMRV administered concomitantly with MenACWY-CRM as compared to MMRV administered alone.||1.2|-3.9|
72527919|NCT00626327|144586470|NON_INFERIORITY_OR_EQUIVALENCE|The immune response of MenACWY-CRM + MMRV group was considered non-inferior to that of MenACWY-CRM group if the lower limit of the two-sided 95% CI around the difference of the percentage of subjects with hSBA ≥1:8 at 6 weeks after the second dose of MenACWY-CRM given to 12 month old toddlers was greater than -10% for each serogroup.|Difference% (MenACWY-CRM+MMRV-MenACWY)|0.0|||||TWO_SIDED|95.0|-4.7|4.5||||||Non-inferiority of immune response of MenACWY-CRM against serogroup A when concomitantly administered with MMRV vaccine as compared to MenACWY-CRM vaccine given alone.||4.5|-4.7|
72527920|NCT00626327|144586470|NON_INFERIORITY_OR_EQUIVALENCE|The immune response of MenACWY-CRM + MMRV group was considered non-inferior to that of MenACWY-CRM group if the lower limit of the two-sided 95% CI around the difference of the percentage of subjects with hSBA ≥1:8 at 6 weeks after the second dose of MenACWY-CRM given to 12 month old toddlers was greater than -10% for each serogroup.|Difference% (MenACWY-CRM+MMRV-MenACWY)|0.0|||||TWO_SIDED|95.0|-1.8|1.9||||||Non-inferiority of immune response of MenACWY-CRM against serogroup C when concomitantly administered with MMRV vaccine as compared to MenACWY-CRM vaccine given alone.||1.9|-1.8|
72527921|NCT00626327|144586470|NON_INFERIORITY_OR_EQUIVALENCE|The immune response of MenACWY-CRM + MMRV group was considered non-inferior to that of MenACWY-CRM group if the lower limit of the two-sided 95% CI around the difference of the percentage of subjects with hSBA ≥1:8 at 6 weeks after the second dose of MenACWY-CRM given to 12 month old toddlers was greater than -10% for each serogroup.|Difference% (MenACWY-CRM+MMRV-MenACWY)|1.0|||||TWO_SIDED|95.0|-1.3|3.9||||||Non-inferiority of immune response of MenACWY-CRM against serogroup W-135 when concomitantly administered with MMRV vaccine as compared to MenACWY vaccine given alone.||3.9|-1.3|
72527922|NCT00626327|144586470|NON_INFERIORITY_OR_EQUIVALENCE|The immune response of MenACWY-CRM + MMRV group was considered non-inferior to that of MenACWY-CRM group if the lower limit of the two-sided 95% CI around the difference of the percentage of subjects with hSBA ≥1:8 at 6 weeks after the second dose of MenACWY-CRM given to 12 month old toddlers was greater than -10% for each serogroup.|Difference% (MenACWY-CRM+MMRV-MenACWY)|2.0|||||TWO_SIDED|95.0|-1.9|5.3||||||Non-inferiority of immune response of MenACWY-CRM against serogroup Y when concomitantly administered with MMRV vaccine as compared to MenACWY-CRM vaccine given alone.||5.3|-1.9|
72527923|NCT00626327|144586475|NON_INFERIORITY_OR_EQUIVALENCE|The immune response of MMRV+MenACWY group was considered non-inferior to that of MMRV group if the lower limit of the two-sided 95% CI of the difference in the percentages of subjects with seroconversion for varicella was greater than -10%.|Difference% (MenACWY-CRM+MMRV- MMRV)|-1.0|||||TWO_SIDED|95.0|-2.4|0.8||||||Non-inferiority of anti-varicella response following one dose of MMRV when administered concomitantly with MenACWY vaccine as compared to MMRV administered alone.||0.8|-2.4|
72527924|NCT01066819|144586500|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.596||||0.0045|TWO_SIDED|95.0|1.704|18.378|||Regression, Logistic|||The statistical analysis is presented for Ethnic origin (ASIAN vs WHITE/CAUCASIAN). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week \[Wk\] 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||18.378|1.704|0.0045
72527925|NCT01066819|144586500|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.989||||0.9755|TWO_SIDED|95.0|0.497|1.967|||Regression, Logistic|||The statistical analysis is presented for Ethnic origin (BLACK vs WHITE/CAUCASIAN). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.967|0.497|0.9755
72527926|NCT01066819|144586500|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.743||||0.4786|TWO_SIDED|95.0|0.327|1.688|||Regression, Logistic|||The statistical analysis is presented for Ethnic origin (HISPANIC vs WHITE/CAUCASIAN). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.688|0.327|0.4786
72527927|NCT01066819|144586500|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.38||||0.014|TWO_SIDED|95.0|1.405|20.597|||Regression, Logistic|||The statistical analysis is presented for Ethnic origin (OTHER vs WHITE/CAUCASIAN). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||20.597|1.405|0.0140
72625342|NCT01098747|144780088|SUPERIORITY_OR_OTHER||Difference in proportion|-9.23||||0.14|TWO_SIDED|95.0|-21.62|3.16||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||8 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||3.16|-21.62|0.140
72625343|NCT01098747|144780089|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.9|||<|0.001|TWO_SIDED|95.0|0.83|0.98||p-value was calculated using CMH test with modified ridit scores, controlling for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||Treatment difference (Ibuprofen sodium - placebo) and the associated CI were calculated based on the weighted Gamma statistic.||0.98|0.83|<0.001
72407315|NCT01573624|144323023|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.2||||0.523||95.0|-4.6|9.1|||Mixed Models Analysis|||No adjustments were made for comparisons between doses of FF + UMEC and FF + VI.||9.1|-4.6|0.523
72407316|NCT01573624|144323023|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.7||||0.29|TWO_SIDED|95.0|-10.5|3.1|||Mixed Models Analysis|||No adjustments were made for comparisons between doses of FF + UMEC and FF + VI.||3.1|-10.5|0.290
72407317|NCT01573624|144323024|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.2||||0.036|TWO_SIDED|95.0|-0.5|0.0|||Mixed Models Analysis|||No pairwise comparisons between doses of FF + UMEC and FF alone were done unless overall F-test for treatment effect was statistically significant at 5% level. Multiplicity across these comparisons was controlled using a step-down closed testing procedure, whereby statistical comparison of the highest dose of FF + UMEC and FF alone was initially performed, and subsequent comparisons at lower doses continued in a step-down manner if preceding comparison was statistically significant at 5% level.||0.0|-0.5|0.036
72527928|NCT01066819|144586500|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.078|||<|0.0001|TWO_SIDED|95.0|1.062|1.094|||Regression, Logistic|||The statistical analysis is presented for treatment duration after VR in weeks. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.094|1.062|<0.0001
72527929|NCT01066819|144586500|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.136||||0.0035|TWO_SIDED|95.0|1.819|20.701|||Regression, Logistic|||The statistical analysis is presented for Ethnic origin (ASIAN vs WHITE/CAUCASIAN). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||20.701|1.819|0.0035
72527930|NCT01066819|144586500|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.903||||0.7821|TWO_SIDED|95.0|0.439|1.857|||Regression, Logistic|||The statistical analysis is presented for Ethnic origin (BLACK vs WHITE/CAUCASIAN). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.857|0.439|0.7821
72527931|NCT01066819|144586500|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.74||||0.4846|TWO_SIDED|95.0|0.317|1.723|||Regression, Logistic|||The statistical analysis is presented for Ethnic origin (HISPANIC vs WHITE/CAUCASIAN). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.723|0.317|0.4846
72527932|NCT01066819|144586500|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.424||||0.017|TWO_SIDED|95.0|1.353|21.749|||Regression, Logistic|||The statistical analysis is presented for Ethnic origin (OTHER vs WHITE/CAUCASIAN). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||21.749|1.353|0.0170
72527933|NCT01066819|144586500|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.695||||0.0125|TWO_SIDED|95.0|0.523|0.925|||Regression, Logistic|||The statistical analysis is presented for HCV RNA at BL in log10(IU/mL). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.925|0.523|0.0125
72527934|NCT01066819|144586500|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.472||||0.0139|TWO_SIDED|95.0|1.288|9.357|||Regression, Logistic|||The statistical analysis is presented for average number of drinks per week (1 vs 0). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||9.357|1.288|0.0139
72527935|NCT01066819|144586500|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.179||||0.6327|TWO_SIDED|95.0|0.601|2.311|||Regression, Logistic|||The statistical analysis is presented for average number of drinks per week (\> 1 vs 0). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||2.311|0.601|0.6327
72527936|NCT01066819|144586500|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.061|||<|0.0001|TWO_SIDED|95.0|1.042|1.08|||Regression, Logistic|||The statistical analysis is presented for treatment duration after VR in weeks. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.080|1.042|<0.0001
72527937|NCT01066819|144586500|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.185||||0.0033|TWO_SIDED|95.0|1.058|1.326|||Regression, Logistic|||The statistical analysis is presented for Cumulative PEG-IFN alfa-2a dose per 1000 ug. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.326|1.058|0.0033
72571554|NCT03276221|144671780|SUPERIORITY||Slope|0.05|STANDARD_ERROR_OF_MEAN|0.11||0.647|TWO_SIDED|||||The p-value was adjusted for multiple comparisons by the Bonferroni correction across outcomes for the verbal recognition memory module. The a priori threshold for statistical significance was 0.0125.|Mixed Models Analysis|Estimates were obtained using generalized estimating equations (GEE) with robust standard errors obtained by the sandwich estimator.|The estimate is the mean difference in the log probability of making a correct choice for the abstinence group above and beyond the monitoring group (positive values indicate higher memory performance for the abstinence group).|The mean difference in scale scores between the abstinence and monitoring groups was estimated via a binomial model with a dummy-coded contrast (0 for monitoring, 1 for abstinence). The model adjusted for change at weeks 2, 3, and 4 of the study, and for a subject's scale scores at baseline.||||0.647
72625344|NCT01098747|144780089|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.04||||0.667|TWO_SIDED|95.0|-0.15|0.24||p-value was calculated using the PH model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Proportional hazards model|||HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model.||0.24|-0.15|0.667
72625345|NCT00189423|144780090|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.58||||0.019|TWO_SIDED|95.0|1.07|2.36|||Fisher Exact|||||2.36|1.07|0.019
72625346|NCT00189423|144780091|NON_INFERIORITY_OR_EQUIVALENCE|non-inferiority margin of 5%||||||0.0001|TWO_SIDED|95.0||||p value is for non-inferiority with a margin of 5% (exact binomial test)|Fisher Exact test, for non-inferiority|||||||0.0001
72407318|NCT01573624|144323024|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.2||||0.064|TWO_SIDED|95.0|-0.5|0.0|||Mixed Models Analysis|||No pairwise comparisons between doses of FF + UMEC and FF alone were done unless overall F-test for treatment effect was statistically significant at 5% level. Multiplicity across these comparisons was controlled using a step-down closed testing procedure, whereby statistical comparison of the highest dose of FF + UMEC and FF alone was initially performed, and subsequent comparisons at lower doses continued in a step-down manner if preceding comparison was statistically significant at 5% level.||0.0|-0.5|0.064
72527938|NCT01066819|144586500|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.227|||<|0.0001|TWO_SIDED|95.0|1.151|1.308|||Regression, Logistic|||The statistical analysis is presented for treatment duration after VR in weeks. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.308|1.151|<0.0001
72527939|NCT01066819|144586500|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.814||||0.0289|TWO_SIDED|95.0|0.676|0.979|||Regression, Logistic|||The statistical analysis is presented for cumulative ribavirin dose per 10000 mg, 1st 12 weeks. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.979|0.676|0.0289
72527940|NCT01066819|144586500|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.276|||<|0.0001|TWO_SIDED|95.0|1.177|1.383|||Regression, Logistic|||The statistical analysis is presented for treatment duration after VR in weeks. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.383|1.177|<0.0001
72527941|NCT01066819|144586500|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.894||||0.0099|TWO_SIDED|95.0|0.821|0.973|||Regression, Logistic|||The statistical analysis is presented for Cumulative ribavirin dose per 10000 mg. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.973|0.821|0.0099
72527942|NCT01066819|144586500|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.945||||0.0058|TWO_SIDED|95.0|1.213|3.12|||Regression, Logistic|||The statistical analysis is presented for age per 10 years. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||3.120|1.213|0.0058
72527943|NCT01066819|144586500|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.262|||<|0.0001|TWO_SIDED|95.0|1.154|1.38|||Regression, Logistic|||The statistical analysis is presented for treatment duration after VR in weeks. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.380|1.154|<0.0001
72527944|NCT01066819|144586500|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.945||||0.0058|TWO_SIDED|95.0|1.213|3.12|||Regression, Logistic|||The statistical analysis is presented for age per 10 years. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||3.120|1.213|0.0058
72527945|NCT01066819|144586500|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.262|||<|0.0001|TWO_SIDED|95.0|1.154|1.38|||Regression, Logistic|||The statistical analysis is presented for treatment duration after VR in weeks. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.380|1.154|<0.0001
72527946|NCT01066819|144586500|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.615||||0.0205|TWO_SIDED|95.0|1.219|10.721|||Regression, Logistic|||The statistical analysis is presented for Ethnic origin (ASIAN vs WHITE/CAUCASIAN). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||10.721|1.219|0.0205
72527947|NCT01066819|144586500|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.981||||0.9557|TWO_SIDED|95.0|0.506|1.903|||Regression, Logistic|||The statistical analysis is presented for Ethnic origin (BLACK vs WHITE/CAUCASIAN). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.903|0.506|0.9557
72527948|NCT01066819|144586500|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.599||||0.2|TWO_SIDED|95.0|0.273|1.312|||Regression, Logistic|||The statistical analysis is presented for Ethnic origin (HISPANIC vs WHITE/CAUCASIAN). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.312|0.273|0.2000
72625347|NCT00189423|144780091|SUPERIORITY_OR_OTHER|||||||0.681|TWO_SIDED|95.0|||||Fisher Exact|||||||0.681
72625348|NCT00189423|144780097|SUPERIORITY_OR_OTHER|||||||0.024|TWO_SIDED|95.0|||||Fisher Exact|||||||0.024
72407319|NCT01573624|144323024|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1||||0.335|TWO_SIDED|95.0|-0.3|0.1|||Mixed Models Analysis|||No pairwise comparisons between doses of FF + UMEC and FF alone were done unless overall F-test for treatment effect was statistically significant at 5% level. Multiplicity across these comparisons was controlled using a step-down closed testing procedure, whereby statistical comparison of the highest dose of FF + UMEC and FF alone was initially performed, and subsequent comparisons at lower doses continued in a step-down manner if preceding comparison was statistically significant at 5% level.||0.1|-0.3|0.335
72407320|NCT01573624|144323024|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3||||0.012|TWO_SIDED|95.0|-0.5|-0.1|||Mixed Models Analysis|||No pairwise comparisons between doses of FF + UMEC and FF alone were done unless overall F-test for treatment effect was statistically significant at 5% level. Multiplicity across these comparisons was controlled using a step-down closed testing procedure, whereby statistical comparison of the highest dose of FF + UMEC and FF alone was initially performed, and subsequent comparisons at lower doses continued in a step-down manner if preceding comparison was statistically significant at 5% level.||-0.1|-0.5|0.012
72407321|NCT01573624|144323024|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.3||||0.023|TWO_SIDED|95.0|-0.5|0.0|||Mixed Models Analysis|||No pairwise comparisons between doses of FF + UMEC and FF alone were done unless overall F-test for treatment effect was statistically significant at 5% level. Multiplicity across these comparisons was controlled using a step-down closed testing procedure, whereby statistical comparison of the highest dose of FF + UMEC and FF alone was initially performed, and subsequent comparisons at lower doses continued in a step-down manner if preceding comparison was statistically significant at 5% level.||0.0|-0.5|0.023
72407322|NCT01573624|144323024|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.4|||<|0.001|TWO_SIDED|95.0|-0.7|-0.2|||Mixed Models Analysis|||||-0.2|-0.7|<0.001
72407323|NCT01573624|144323024|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.2||||0.104|TWO_SIDED|95.0|0.0|0.4|||Mixed Models Analysis|||No adjustments were made for comparisons between doses of FF + UMEC and FF + VI.||0.4|0.0|0.104
72527949|NCT01066819|144586500|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.684||||0.0437|TWO_SIDED|95.0|1.037|13.083|||Regression, Logistic|||The statistical analysis is presented for (OTHER vs WHITE/CAUCASIAN). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||13.083|1.037|0.0437
72527950|NCT01066819|144586500|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|134.6|||<|0.0001|TWO_SIDED|95.0|17.956|1009.0|||Regression, Logistic|||The statistical analysis is presented for On-treatment response (RVR vs NO RVR/EVR). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1009.0|17.956|<0.0001
72527951|NCT01066819|144586500|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|77.905|||<|0.0001|TWO_SIDED|95.0|10.521|576.85|||Regression, Logistic|||The statistical analysis is presented for On-treatment response (cEVR vs NO RVR/EVR). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||576.85|10.521|<0.0001
72527952|NCT01066819|144586500|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|14.527||||0.0105|TWO_SIDED|95.0|1.872|112.73|||Regression, Logistic|||The statistical analysis is presented for On-treatment response (pEVR vs NO RVR/EVR). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||112.73|1.872|0.0105
72527953|NCT01066819|144586500|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.563||||0.0041|TWO_SIDED|95.0|1.152|2.12|||Regression, Logistic|||The statistical analysis is presented for age per 10 years. The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||2.120|1.152|0.0041
72407324|NCT01573624|144323024|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.2||||0.062|TWO_SIDED|95.0|0.0|0.5|||Mixed Models Analysis|||No adjustments were made for comparisons between doses of FF + UMEC and FF + VI.||0.5|0.0|0.062
72407325|NCT01573624|144323024|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.3||||0.006|TWO_SIDED|95.0|0.1|0.6|||Mixed Models Analysis|||No adjustments were made for comparisons between doses of FF + UMEC and FF + VI.||0.6|0.1|0.006
72527954|NCT01066819|144586500|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.557|||<|0.0001|TWO_SIDED|95.0|2.405|12.838|||Regression, Logistic|||The statistical analysis is presented for On-treatment response, combined (RVR vs NO RVR). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||12.838|2.405|<0.0001
72527955|NCT01066819|144586500|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.822||||0.0037|TWO_SIDED|95.0|1.216|2.732|||Regression, Logistic|||The statistical analysis is presented for age per 10 years. The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||2.732|1.216|0.0037
72625349|NCT03309202|144780186|OTHER||Mean Difference (Final Values)|130.47|||||TWO_SIDED|90.0|101.57|167.6|||ANOVA|The natural log transformed parameter was used.|Estimate mean difference was derived from ratio (%) of adjusted geometric means of Test and Reference.Cohort 2 (Mild Hepatic Impairment) was Test and Cohort 1 (Without Hepatic Impairment) was Reference.|||167.60|101.57|
72407326|NCT01573624|144323024|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.1||||0.217|TWO_SIDED|95.0|-0.1|0.4|||Mixed Models Analysis|||No adjustments were made for comparisons between doses of FF + UMEC and FF + VI.||0.4|-0.1|0.217
72407327|NCT01573624|144323024|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.2||||0.143|TWO_SIDED|95.0|-0.1|0.4|||Mixed Models Analysis|||No adjustments were made for comparisons between doses of FF + UMEC and FF + VI.||0.4|-0.1|0.143
72407328|NCT00554749|144323025|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.09|STANDARD_DEVIATION|0.43|<|0.001||95.0|1.69|2.49|||paired t-test|Paired t-test of SSQ at baseline vs at 6 months, degrees of freedom=6. Difference in SSQ is reported.||||2.49|1.69|<0.001
72407329|NCT03417141|144323027|SUPERIORITY|||||||0.014|||||||Wilcoxon (Mann-Whitney)|||Week 12||||0.014
72407330|NCT03417141|144323027|SUPERIORITY|||||||0.006|||||||Wilcoxon (Mann-Whitney)|||Week 24||||0.006
72407331|NCT03417141|144323028|SUPERIORITY|||||||0.093|||||||Wilcoxon (Mann-Whitney)|||||||0.093
72571555|NCT03276221|144671781|SUPERIORITY||Slope|-0.06|STANDARD_ERROR_OF_MEAN|0.09||0.511|TWO_SIDED|||||The p-value was adjusted for multiple comparisons by the Bonferroni correction across outcomes for the verbal recognition memory module. The a priori threshold for statistical significance was 0.0125.|Mixed Models Analysis|Estimates were obtained using generalized estimating equations (GEE) with robust standard errors obtained by the sandwich estimator.|The estimate is the mean difference in the log probability of making a correct choice for the abstinence group above and beyond the monitoring group (positive values indicate higher memory performance for the abstinence group).|The mean difference in scale scores between the abstinence and monitoring groups was estimated via a binomial model with a dummy-coded contrast (0 for monitoring, 1 for abstinence). The model adjusted for change at weeks 2, 3, and 4 of the study, and for a subject's scale scores at baseline.||||0.511
72571556|NCT03276221|144671782|SUPERIORITY||Slope|-0.12|STANDARD_ERROR_OF_MEAN|0.12||0.312|TWO_SIDED|||||The p-value was adjusted for multiple comparisons by the Bonferroni correction across outcomes for the multitasking test module. The a priori threshold for statistical significance was 0.0125.|Mixed Models Analysis|Estimates were obtained using generalized estimating equations (GEE) with robust standard errors obtained by the sandwich estimator.|The estimate is the mean difference in the log probability of making an error for the abstinence group above and beyond the monitoring group (positive values indicate higher error commission for the abstinence group).|The mean difference in scale scores between the abstinence and monitoring groups was estimated via a binomial model with a dummy-coded contrast (0 for monitoring, 1 for abstinence). The model adjusted for change at weeks 2, 3, and 4 of the study, and for a subject's scale scores at baseline.||||0.312
72625350|NCT03309202|144780186|OTHER||Mean Difference (Final Values)|117.49|||||TWO_SIDED|90.0|91.46|150.93|||ANOVA|The natural log transformed parameter was used.|Estimate mean difference was derived from ratio (%) of adjusted geometric means of Test and Reference.Cohort 3 (Moderate Hepatic Impairment) was Test and Cohort 1 (Without Hepatic Impairment) was Reference.|||150.93|91.46|
72407332|NCT03417141|144323029|SUPERIORITY|||||||0.57|||||||Wilcoxon (Mann-Whitney)|||||||0.57
72407333|NCT03417141|144323030|SUPERIORITY|||||||0.55|||||||Wilcoxon (Mann-Whitney)|||||||0.55
72527956|NCT01066819|144586500|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|11.342|||<|0.0001|TWO_SIDED|95.0|3.977|32.347|||Regression, Logistic|||The statistical analysis is presented for On-treatment response, combined (RVR vs NO RVR). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||32.347|3.977|<0.0001
72527957|NCT01066819|144586500|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.112|||<|0.0001|TWO_SIDED|95.0|1.068|1.158|||Regression, Logistic|||The statistical analysis is presented for treatment duration after VR in weeks. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2b.||1.158|1.068|<0.0001
72527958|NCT01066819|144586500|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.112|||<|0.0001|TWO_SIDED|95.0|1.068|1.158|||Regression, Logistic|||The statistical analysis is presented for treatment duration after VR in weeks. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2b.||1.158|1.068|<0.0001
72527959|NCT01066819|144586500|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.921||||0.0035|TWO_SIDED|95.0|1.686|14.362|||Regression, Logistic|||The statistical analysis is presented for On-treatment response, combined (RVR vs NO RVR). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2b.||14.362|1.686|0.0035
72527960|NCT01066819|144586517|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.441||||0.0162|TWO_SIDED|95.0|0.226|0.859|||Regression, Logistic|||The statistical analysis is presented for Sex (MALE vs FEMALE). The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.859|0.226|0.0162
72527961|NCT01066819|144586517|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.745||||0.0156|TWO_SIDED|95.0|1.111|2.741|||Regression, Logistic|||The statistical analysis is presented for HCV RNA at BL in log10(IU/mL). The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||2.741|1.111|0.0156
72576767|NCT00261443|144680647|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.21||||0.05|TWO_SIDED|95.0|-0.43|0.0||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 28 Comparison||0.00|-0.43|0.050
72407334|NCT03706690|144323037|SUPERIORITY||Hazard Ratio (HR)|0.75||||0.038|TWO_SIDED|95.0|0.578|0.986|||Log Rank|Analysis performed using stratified log-rank test, adjusting for the level of PD-L1 expression and prior therapy (cCRT vs sCRT).||The hazard ratio and confidence intervals (CIs) were calculated using a stratified Cox proportional hazards model, adjusting for the level of programmed death ligand 1 (PD-L1) expression (PD-L1 \<1% versus \[vs\] PD-L1 \>=1%) and prior therapy (concurrent \[c\]CRT vs sequential \[s\]CRT), with treatment as the only covariate and ties handled by Efron approach.||0.986|0.578|0.038
72407335|NCT03706690|144323038|SUPERIORITY||Hazard Ratio (HR)|0.87||||0.346|TWO_SIDED|95.0|0.656|1.166|||Log Rank|Analysis performed using stratified log-rank test, adjusting for level of PD-L1 expression and prior therapy (cCRT vs. sCRT).||For mITT set. The hazard ratio and CIs were calculated using a stratified Cox proportional hazards model, adjusting for the level of PD-L1 expression (PD-L1 \<1% vs PD-L1 \>=1%) and prior therapy (cCRT vs sCRT), with treatment as the only covariate and ties handled by Efron approach.||1.166|0.656|0.346
72625351|NCT03309202|144780186|OTHER||Mean Difference (Final Values)|130.55|||||TWO_SIDED|90.0|101.63|167.7|||ANOVA|The natural log transformed parameter was used.|Estimate mean difference was derived from ratio (%) of adjusted geometric means of Test and Reference.Cohort 4 (Severe Hepatic Impairment) was Test and Cohort 1 (Without Hepatic Impairment) was Reference.|||167.70|101.63|
72625352|NCT03309202|144780187|OTHER||Mean Difference (Final Values)|136.37|||||TWO_SIDED|90.0|94.63|196.53|||ANOVA|The natural log transformed parameter was used.|Estimate mean difference was derived from ratio (%) of adjusted geometric means of Test and Reference.Cohort 2 (Mild Hepatic Impairment) was Test and Cohort 1 (Without Hepatic Impairment) was Reference.|||196.53|94.63|
72407336|NCT03706690|144323038|SUPERIORITY||Hazard Ratio (HR)|0.87||||0.346|TWO_SIDED|95.0|0.663|1.162|||Log Rank|Analysis performed using stratified log-rank test, adjusting for level of PD-L1 expression and prior therapy (cCRT vs. sCRT).||For ITT set. The hazard ratio and CIs were calculated using a stratified Cox proportional hazards model, adjusting for the level of PD-L1 expression (PD-L1 \<1% vs PD-L1 \>=1%) and prior therapy (cCRT vs sCRT), with treatment as the only covariate and ties handled by Efron approach.||1.162|0.663|0.346
72527962|NCT01066819|144586517|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.372||||0.1075|TWO_SIDED|95.0|0.829|6.789|||Regression, Logistic|||The statistical analysis is presented for Alanine Aminotransferase (ALT) ratio at BL (\<=1 vs \> 3). The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||6.789|0.829|0.1075
72527963|NCT01066819|144586517|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.906||||0.8518|TWO_SIDED|95.0|0.321|2.559|||Regression, Logistic|||The statistical analysis is presented for ALT ratio at BL (\> 1 - 3 vs \> 3). The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||2.559|0.321|0.8518
72527964|NCT01066819|144586517|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.969||||0.0012|TWO_SIDED|95.0|0.951|0.988|||Regression, Logistic|||The statistical analysis is presented for treatment duration after VR in weeks. The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.988|0.951|0.0012
72527965|NCT01066819|144586517|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.441||||0.0162|TWO_SIDED|95.0|0.226|0.859|||Regression, Logistic|||The statistical analysis is presented for Sex (MALE vs FEMALE). The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.859|0.226|0.0162
72527966|NCT01066819|144586517|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.745||||0.0156|TWO_SIDED|95.0|1.111|2.741|||Regression, Logistic|||The statistical analysis is presented for HCV RNA at BL in log10(IU/mL). The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||2.741|1.111|0.0156
72527967|NCT01066819|144586517|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.372||||0.1075|TWO_SIDED|95.0|0.829|6.789|||Regression, Logistic|||The statistical analysis is presented for ALT ratio at BL (\<=1 vs \> 3). The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||6.789|0.829|0.1075
72527968|NCT01066819|144586517|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.906||||0.8518|TWO_SIDED|95.0|0.321|2.559|||Regression, Logistic|||The statistical analysis is presented for ALT ratio at BL (\> 1 - 3 vs \> 3). The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||2.559|0.321|0.8518
72527969|NCT01066819|144586517|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.969||||0.0012|TWO_SIDED|95.0|0.951|0.988|||Regression, Logistic|||The statistical analysis is presented for treatment duration after VR in weeks. The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.988|0.951|0.0012
72527970|NCT01066819|144586517|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.848||||0.0017|TWO_SIDED|95.0|0.765|0.94|||Regression, Logistic|||The statistical analysis is presented for treatment duration after VR in weeks. The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.940|0.765|0.0017
72527971|NCT01066819|144586517|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.848||||0.0017|TWO_SIDED|95.0|0.765|0.94|||Regression, Logistic|||The statistical analysis is presented for treatment duration after VR in weeks. The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.940|0.765|0.0017
72527972|NCT01066819|144586517|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.401||||0.0071|TWO_SIDED|95.0|0.206|0.78|||Regression, Logistic|||The statistical analysis is presented for Sex (MALE vs FEMALE). The logistic regression analysis for relapse was performed for association between treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.780|0.206|0.0071
72527973|NCT01066819|144586517|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.016||||0.0006|TWO_SIDED|95.0|0.001|0.169|||Regression, Logistic|||The statistical analysis is presented for On-treatment response (RVR vs NO RVR/EVR). The logistic regression analysis for relapse was performed for association between treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.169|0.001|0.0006
72625353|NCT03309202|144780187|OTHER||Mean Difference (Final Values)|124.23|||||TWO_SIDED|90.0|86.2|179.03|||ANOVA|The natural log transformed parameter was used.|Estimate mean difference was derived from ratio (%) of adjusted geometric means of Test and Reference.Cohort 3 (Moderate Hepatic Impairment) was Test and Cohort 1 (Without Hepatic Impairment) was Reference.|||179.03|86.20|
72625354|NCT03309202|144780187|OTHER||Mean Difference (Final Values)|118.65|||||TWO_SIDED|90.0|82.33|170.99|||ANOVA|The natural log transformed parameter was used.|Estimate mean difference was derived from ratio (%) of adjusted geometric means of Test and Reference.Cohort 4 (Severe Hepatic Impairment) was Test and Cohort 1 (Without Hepatic Impairment) was Reference.|||170.99|82.33|
72625355|NCT03309202|144780188|OTHER||Mean Difference (Final Values)|124.7309|||||TWO_SIDED|90.0|82.5275|188.5165|||ANOVA|The natural log transformed parameter was used.|Estimate mean difference was derived from ratio (%) of adjusted geometric means of Test and Reference.Cohort 2 (Mild Hepatic Impairment) was Test and Cohort 1 (Without Hepatic Impairment) was Reference.|||188.5165|82.5275|
72527974|NCT01066819|144586517|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.076||||0.0255|TWO_SIDED|95.0|0.008|0.729|||Regression, Logistic|||The statistical analysis is presented for On-treatment response (cEVR vs NO RVR/EVR). The logistic regression analysis for relapse was performed for association between treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.729|0.008|0.0255
72527975|NCT01066819|144586517|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.184||||0.1501|TWO_SIDED|95.0|0.018|1.845|||Regression, Logistic|||The statistical analysis is presented for On-treatment response (pEVR vs NO RVR/EVR). The logistic regression analysis for relapse was performed for association between treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.845|0.018|0.1501
72527976|NCT01066819|144586517|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|27.25|||<|0.0001|TWO_SIDED|95.0|6.729|110.35|||Regression, Logistic|||The statistical analysis is presented for On-treatment response (cEVR vs RVR). The logistic regression analysis for relapse was performed for association between treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||110.35|6.729|<0.0001
72527977|NCT00805194|144586525|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.79||||0.0019|TWO_SIDED|95.0|0.68|0.92|||Regression, Cox||Hazard Ratio (HR) below 1 favors nintedanib|HR, Confidence Interval (CI) and p-value obtained from the proportional hazards model stratified by baseline ECOG PS (0 vs 1), tumour histology (squamous vs non-squamous), brain metastases at baseline (yes vs no) and prior treatment with bevacizumab (yes vs no)||0.92|0.68|0.0019
72527978|NCT00805194|144586526|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.75||||0.0073|TWO_SIDED|95.0|0.6|0.92||HR, CI and p-value obtained from the prop. hazards model stratified by baseline ECOG PS (0 vs 1 - one pat. had 2), brain metastases at baseline (yes vs no) and prior treatment with bevacizumab (yes vs no)|Regression, Cox||"The overall alpha level followed a Lan-DeMets spending function with O'Brien-Fleming shape parameter to preserve an overall 2-sided alpha level of 0.05.~HR below 1 favors nintedanib"|"Hierarchical testing was tested in a fixed sequence of statistical hypotheses in (1) patients with adenocarcinoma and \<9 months since start of first-line therapy, (2) patients with adenocarcinoma, and (3) all patients. Each hypothesis could be only tested at the pre-specified alpha level if the previous null hypothesis in the testing sequence had been rejected.~Overall survival for patients with adenocarcinoma and \<9 months since start of first line therapy."||0.92|0.60|0.0073
72527979|NCT00805194|144586526|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.83||||0.0359|TWO_SIDED|95.0|0.7|0.99||HR, CI and p-value obtained from the prop. hazards model stratified by baseline ECOG PS (0 vs 1 - one pat. had 2), brain metastases at baseline (yes vs no) and prior treatment with bevacizumab (yes vs no)|Regression, Cox||"The overall alpha level followed a Lan-DeMets spending function with O'Brien-Fleming shape parameter to preserve an overall 2-sided alpha level of 0.05.~HR below 1 favors nintedanib"|"Hierarchical testing was tested in a fixed sequence of statistical hypotheses in (1) patients with adenocarcinoma and \<9 months since start of first-line therapy, (2) patients with adenocarcinoma, and (3) all patients. Each hypothesis could be only tested at the pre-specified alpha level if the previous null hypothesis in the testing sequence had been rejected.~Overall survival for patients with adenocarcinoma."||0.99|0.70|0.0359
72527980|NCT00805194|144586526|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.94||||0.272|TWO_SIDED|95.0|0.83|1.05||HR, CI and p-value obtained from the prop. hazards model stratified by baseline ECOG PS (0 vs 1 - one pat. had 2), tumour histology (squamous vs non-squamous), brain metastases at baseline (yes vs no) and prior treatment with bevacizumab (yes vs no)|Regression, Cox||The overall alpha level followed a Lan-DeMets spending function with O'Brien-Fleming shape parameter to preserve an overall 2-sided alpha level of 0.05. HR below 1 favors nintedanib|"Hierarchical testing was tested in a fixed sequence of statistical hypotheses in (1) patients with adenocarcinoma and \<9 months since start of first-line therapy, (2) patients with adenocarcinoma, and (3) all patients. Each hypothesis could be only tested at the pre-specified alpha level if the previous null hypothesis in the testing sequence had been rejected.~Overall survival for all patients."||1.05|0.83|0.2720
72527981|NCT00805194|144586527|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.85||||0.007|TWO_SIDED|95.0|0.75|0.96||HR, CI and p-value obtained from the proportional hazards model stratified by baseline ECOG PS (0 vs 1), tumour histology (squamous vs non-squamous), brain metastases at baseline (yes vs no) and prior treatment with bevacizumab (yes vs no)|Regression, Cox||HR below 1 favors nintedanib|||0.96|0.75|0.0070
72527982|NCT00805194|144586528|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.82||||0.0012|TWO_SIDED|95.0|0.73|0.93||HR, CI and p-value obtained from the proportional hazards model stratified by baseline ECOG PS (0 vs 1), tumour histology (squamous vs non-squamous), brain metastases at baseline (yes vs no) and prior treatment with bevacizumab (yes vs no)|Regression, Cox||HR below 1 favors nintedanib|||0.93|0.73|0.0012
72527983|NCT00805194|144586529|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.34||||0.3067|TWO_SIDED|95.0|0.76|2.39||Odds ratio and p-value are obtained from logistic regression model adjusted for baseline ECOG PS (0 vs 1)|Regression, Logistic||An odds ratio \>1 indicates a benefit to nintedanib|Analysis based on the central independent review||2.39|0.76|0.3067
72527984|NCT00805194|144586529|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.41||||0.0761|TWO_SIDED|95.0|0.96|2.08||Odds ratio and p-value are obtained from logistic regression model adjusted for baseline ECOG PS (0 vs 1)|Regression, Logistic||An odds ratio \>1 indicates a benefit to nintedanib|Analysis based on the investigator's assessment||2.08|0.96|0.0761
72407337|NCT03706690|144323039|SUPERIORITY||Hazard Ratio (HR)|0.74||||0.026|TWO_SIDED|95.0|0.575|0.966|||Log Rank|Analysis performed using stratified log-rank test, adjusting for the level of PD-L1 expression and prior therapy (cCRT vs sCRT).||The hazard ratio and CIs were calculated using a stratified Cox proportional hazards model, adjusting for the level of PD-L1 expression (PD-L1 \<1% vs PD-L1\>=1%) and prior therapy (cCRT vs sCRT), with treatment as the only covariate and ties handled by Efron approach.||0.966|0.575|0.026
72527985|NCT00805194|144586532|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.68|||<|0.0001|TWO_SIDED|95.0|1.35|2.09||Odds ratio and p-value are obtained from logistic regression model adjusted for baseline ECOG PS (0 vs 1)|Regression, Logistic||An odds ratio \>1 indicates a benefit to nintedanib|Analysis based on the central independent review||2.09|1.35|<0.0001
72527986|NCT00805194|144586532|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.64|||<|0.0001|TWO_SIDED|95.0|1.31|2.05||Odds ratio and p-value are obtained from logistic regression model adjusted for baseline ECOG PS (0 vs 1)|Regression, Logistic||An odds ratio \>1 indicates a benefit to nintedanib|Analysis based on investigator's assessment||2.05|1.31|<0.0001
72527987|NCT00805194|144586534|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-value generated from ANOVA model adjusted for baseline ECOG PS (0 vs. 1), tumour histology (squamous vs non-squamous), brain metastases at baseline (yes vs no) and prior treatment with bevacizumab (yes vs no)|ANOVA|||Analysis based on the central independent review||||<0.0001
72527988|NCT00805194|144586534|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-value generated from ANOVA model adjusted for baseline ECOG PS (0 vs. 1), tumour histology (squamous vs non-squamous), brain metastases at baseline (yes vs no) and prior treatment with bevacizumab (yes vs no)|ANOVA|||Analysis based on the investigator's assessment||||<0.0001
72527989|NCT00805194|144586535|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.03||||0.7282|TWO_SIDED|95.0|0.87|1.21||HR, CI and p-value obtained from the prop. hazards model stratified by baseline ECOG PS (0 vs 1 - one pat.had 2), tumour histology (squamous vs non-squamous), brain metastases at baseline (yes vs no) and prior treatment with bevacizumab (yes vs no)|Regression, Cox||HR below 1 favors nintedanib|||1.21|0.87|0.7282
72527990|NCT00805194|144586536|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.9||||0.1858|TWO_SIDED|95.0|0.77|1.05||HR, CI and p-value obtained from the prop. hazards model stratified by baseline ECOG PS (0 vs \>=1), tumour histology (squamous vs non-squamous), brain metastases at baseline (yes vs no) and prior treatment with bevacizumab (yes vs no)|Regression, Cox||HR below 1 favors nintedanib|Analysis evaluating the time to deterioration of cough||1.05|0.77|0.1858
72625356|NCT03309202|144780188|OTHER||Mean Difference (Final Values)|147.0778|||||TWO_SIDED|90.0|97.3132|222.2911|||ANOVA|The natural log transformed parameter was used.|Estimate mean difference was derived from ratio (%) of adjusted geometric means of Test and Reference.Cohort 3 (Moderate Hepatic Impairment) was Test and Cohort 1 (Without Hepatic Impairment) was Reference.|||222.2911|97.3132|
72407338|NCT03706690|144323041|SUPERIORITY||Odds Ratio (OR)|1.51||||0.128|TWO_SIDED|95.0|0.891|2.607|||Regression, Logistic|||For mITT set. The comparison was performed using a logistic regression model, with treatment as a covariate and adjusting for the level of PD-L1 expression (PD-L1 \<1% vs. PD-L1 \>=1%) and prior therapy (cCRT vs. sCRT), with 95% CI calculated by profile likelihood.||2.607|0.891|0.128
72527991|NCT00805194|144586536|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.05||||0.5203|TWO_SIDED|95.0|0.91|1.2||HR, CI and p-value obtained from the prop. hazards model stratified by baseline ECOG PS (0 vs \>=1), tumour histology (squamous vs non-squamous), brain metastases at baseline (yes vs no) and prior treatment with bevacizumab (yes vs no)|Regression, Cox||HR below 1 favors nintedanib|Analysis evaluating the time to deterioration of dyspnoea||1.20|0.91|0.5203
72527992|NCT00805194|144586536|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.95||||0.4373|TWO_SIDED|95.0|0.82|1.09||HR, CI and p-value obtained from the prop. hazards model stratified by baseline ECOG PS (0 vs \>= 1), tumour histology (squamous vs non-squamous), brain metastases at baseline (yes vs no) and prior treatment with bevacizumab (yes vs no)|Regression, Cox||HR below 1 favors nintedanib|Analysis evaluating the time to deterioration of pain||1.09|0.82|0.4373
72527993|NCT02275052|144586548|SUPERIORITY_OR_OTHER||Least squares mean difference|3.31||||0.79|TWO_SIDED|95.0|-21.12|27.74||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least squares mean change difference=UMEC/VI 62.5/25 µg minus Placebo.|||27.74|-21.12|0.790
72527994|NCT02275052|144586549|SUPERIORITY_OR_OTHER||Least squares mean difference|0.206|||<|0.001|TWO_SIDED|95.0|0.167|0.246|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM)|Least squares mean change difference=UMEC/VI 62.5/25 µg minus Placebo.|||0.246|0.167|<0.001
72527995|NCT02275052|144586550|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.346|||<|0.001|TWO_SIDED|95.0|-0.487|-0.204|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM)|Least squares mean change difference=UMEC/VI 62.5/25 µg minus Placebo.|||-0.204|-0.487|<0.001
72527996|NCT02275052|144586551|SUPERIORITY_OR_OTHER||Least squares mean difference|0.259|||<|0.001|TWO_SIDED|95.0|0.194|0.324|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM)|Least squares mean change difference=UMEC/VI 62.5/25 µg minus Placebo.|||0.324|0.194|<0.001
72527997|NCT01143116|144586552|OTHER|||||||0.625|||||||Wilcoxon (Mann-Whitney)|||||||0.6250
72527998|NCT01143116|144586552|OTHER|||||||0.75|||||||Wilcoxon (Mann-Whitney)|||||||0.7500
72527999|NCT01143116|144586553|OTHER|||||||0.875|||||||Wilcoxon (Mann-Whitney)|||||||0.8750
72528000|NCT01143116|144586553|OTHER|||||||0.625|||||||Wilcoxon (Mann-Whitney)|||||||0.6250
72528001|NCT01143116|144586554|OTHER|||||||0.0254|||||||Wilcoxon (Mann-Whitney)|||||||0.0254
72528002|NCT01143116|144586554|OTHER|||||||0.0039|||||||Wilcoxon (Mann-Whitney)|||||||0.0039
72528003|NCT01143116|144586555|OTHER|||||||1|||||||Wilcoxon (Mann-Whitney)|||||||1.0
72528004|NCT01143116|144586555|OTHER|||||||1|||||||Wilcoxon (Mann-Whitney)|||||||1.0000
72528005|NCT01143116|144586556|OTHER|||||||1|||||||Wilcoxon (Mann-Whitney)|||||||1.0
72528006|NCT01143116|144586556|OTHER|||||||1|||||||Wilcoxon (Mann-Whitney)|||||||1.0000
72528007|NCT01143116|144586557|OTHER|||||||1|||||||Wilcoxon (Mann-Whitney)|||||||1.0000
72528008|NCT01143116|144586558|OTHER|||||||1|||||||Wilcoxon (Mann-Whitney)|||||||1.0000
72528009|NCT01143116|144586559|OTHER|||||||0.0313|||||||Wilcoxon (Mann-Whitney)|||||||0.0313
72528010|NCT01143116|144586559|OTHER|||||||0.0078|||||||Wilcoxon (Mann-Whitney)|||||||0.0078
72528011|NCT01143116|144586560|OTHER|||||||0.7188|||||||Wilcoxon (Mann-Whitney)|||||||0.7188
72528012|NCT01143116|144586560|OTHER|||||||0.6406|||||||Wilcoxon (Mann-Whitney)|||||||0.6406
72528013|NCT01143116|144586561|OTHER|||||||0.4375|||||||Wilcoxon (Mann-Whitney)|||||||0.4375
72528014|NCT01143116|144586561|OTHER|||||||0.2969|||||||Wilcoxon (Mann-Whitney)|||||||0.2969
72528015|NCT01143116|144586562|OTHER|||||||0.5391|||||||Wilcoxon (Mann-Whitney)|||||||0.5391
72528016|NCT01143116|144586562|OTHER|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||||||0.0010
72528017|NCT01143116|144586563|OTHER|||||||0.4766|||||||Wilcoxon (Mann-Whitney)|||||||0.4766
72528018|NCT01143116|144586563|OTHER|||||||0.0068|||||||Wilcoxon (Mann-Whitney)|||||||0.0068
72571557|NCT03276221|144671783|SUPERIORITY||Slope|1.92|STANDARD_ERROR_OF_MEAN|9.27||0.836|TWO_SIDED|||||The p-value was adjusted for multiple comparisons by the Bonferroni correction across outcomes for the multitasking test module. The a priori threshold for statistical significance was 0.0125.|Mixed Models Analysis|Estimates were obtained using generalized estimating equations (GEE) with robust standard errors obtained by the sandwich estimator.|The estimate is the mean difference in the median response latency for the abstinence group above and beyond the monitoring group (positive values indicate higher slower responses for the abstinence group).|The mean difference in scale scores between the abstinence and monitoring groups was estimated via a binomial model with a dummy-coded contrast (0 for monitoring, 1 for abstinence). The model adjusted for change at weeks 2, 3, and 4 of the study, and for a subject's scale scores at baseline.||||0.836
72625357|NCT03309202|144780188|OTHER||Mean Difference (Final Values)|224.7373|||||TWO_SIDED|90.0|148.6962|339.6647|||ANOVA|The natural log transformed parameter was used.|Estimate mean difference was derived from ratio (%) of adjusted geometric means of Test and Reference.Cohort 4 (Severe Hepatic Impairment) was Test and Cohort 1 (Without Hepatic Impairment) was Reference.|||339.6647|148.6962|
72625358|NCT03309202|144780189|OTHER||Mean Difference (Final Values)|162.58|||||TWO_SIDED|90.0|103.12|256.32|||ANOVA|The natural log transformed parameter was used.|Estimate mean difference was derived from ratio (%) of adjusted geometric means of Test and Reference.Cohort 2 (Mild Hepatic Impairment) was Test and Cohort 1 (Without Hepatic Impairment) was Reference.|||256.32|103.12|
72625359|NCT03309202|144780189|OTHER||Mean Difference (Final Values)|172.74|||||TWO_SIDED|90.0|109.56|272.35|||ANOVA|The natural log transformed parameter was used.|Estimate mean difference was derived from ratio (%) of adjusted geometric means of Test and Reference.Cohort 3 (Moderate Hepatic Impairment) was Test and Cohort 1 (Without Hepatic Impairment) was Reference.|||272.35|109.56|
72407339|NCT03706690|144323041|SUPERIORITY||Odds Ratio (OR)|1.54||||0.105|TWO_SIDED|95.0|0.915|2.638|||Regression, Logistic|||For ITT set. The comparison was performed using a logistic regression model, with treatment as a covariate and adjusting for the level of PD-L1 expression (PD-L1 \<1% vs. PD-L1 \>=1%) and prior therapy (cCRT vs. sCRT), with 95% CI calculated by profile likelihood.||2.638|0.915|0.105
72528019|NCT01143116|144586564|OTHER|||||||0.0625|||||||Wilcoxon (Mann-Whitney)|||||||0.0625
72528020|NCT01143116|144586564|OTHER|||||||0.418|||||||Wilcoxon (Mann-Whitney)|||||||0.4180
72528021|NCT00808028|144586574|SUPERIORITY_OR_OTHER||||||>|0.9999|||||||Binomial Distribution|||Strain A05: Response rate was compared with whether greater than (\>) 50% of participants had fold rise \>=4 using right one-sided exact test based on binomial distribution and the corresponding p-values were calculated. p-value \< 0.025 was considered significant.||||>0.9999
72528022|NCT00808028|144586574|SUPERIORITY_OR_OTHER|||||||0.0007|||||||Binomial Distribution|||Strain A05: Response rate was compared with whether greater than (\>) 50% of participants had fold rise \>=4 using right one-sided exact test based on binomial distribution and the corresponding p-values were calculated. p-value \< 0.025 was considered significant.||||0.0007
72528023|NCT00808028|144586574|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Binomial Distribution|||Strain A05: Response rate was compared with whether greater than (\>) 50% of participants had fold rise \>=4 using right one-sided exact test based on binomial distribution and the corresponding p-values were calculated. p-value \< 0.025 was considered significant.||||<0.0001
72528024|NCT00808028|144586574|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Binomial Distribution|||Strain A05: Response rate was compared with whether greater than (\>) 50% of participants had fold rise \>=4 using right one-sided exact test based on binomial distribution and the corresponding p-values were calculated. p-value \< 0.025 was considered significant.||||<0.0001
72528025|NCT00808028|144586574|SUPERIORITY_OR_OTHER||||||>|0.9999|||||||Binomial Distribution|||Strain B02: Response rate was compared with whether greater than (\>) 50% of participants had fold rise \>=4 using right one-sided exact test based on binomial distribution and the corresponding p-values were calculated. p-value \< 0.025 was considered significant.||||>0.9999
72528026|NCT00808028|144586574|SUPERIORITY_OR_OTHER|||||||0.0392|||||||Binomial Distribution|||Strain B02: Response rate was compared with whether greater than (\>) 50% of participants had fold rise \>=4 using right one-sided exact test based on binomial distribution and the corresponding p-values were calculated. p-value \< 0.025 was considered significant.||||0.0392
72528027|NCT00808028|144586574|SUPERIORITY_OR_OTHER|||||||0.0225|||||||Binomial Distribution|||Strain B02: Response rate was compared with whether greater than (\>) 50% of participants had fold rise \>=4 using right one-sided exact test based on binomial distribution and the corresponding p-values were calculated. p-value \< 0.025 was considered significant.||||0.0225
72528028|NCT00808028|144586574|SUPERIORITY_OR_OTHER|||||||0.0244|||||||Binomial Distribution|||Strain B02: Response rate was compared with whether greater than (\>) 50% of participants had fold rise \>=4 using right one-sided exact test based on binomial distribution and the corresponding p-values were calculated. p-value \< 0.025 was considered significant.||||0.0244
72528029|NCT00808028|144586575|SUPERIORITY_OR_OTHER||||||>|0.9999|||||||Binomial Distribution|||Strain A05: Response rate was compared with whether greater than (\>) 50% of participants had fold rise \>=4 using right one-sided exact test based on binomial distribution and the corresponding p-values were calculated. p-value \< 0.025 was considered significant.||||>0.9999
72528030|NCT00808028|144586575|SUPERIORITY_OR_OTHER|||||||0.0004|||||||Binomial Distribution|||Strain A05: Response rate was compared with whether greater than (\>) 50% of participants had fold rise \>=4 using right one-sided exact test based on binomial distribution and the corresponding p-values were calculated. p-value \< 0.025 was considered significant.||||0.0004
72528031|NCT00808028|144586575|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Binomial Distribution|||Strain A05: Response rate was compared with whether greater than (\>) 50% of participants had fold rise \>=4 using right one-sided exact test based on binomial distribution and the corresponding p-values were calculated. p-value \< 0.025 was considered significant.||||<0.0001
72528032|NCT00808028|144586575|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Binomial Distribution|||Strain A05: Response rate was compared with whether greater than (\>) 50% of participants had fold rise \>=4 using right one-sided exact test based on binomial distribution and the corresponding p-values were calculated. p-value \< 0.025 was considered significant.||||<0.0001
72528033|NCT00808028|144586575|SUPERIORITY_OR_OTHER||||||>|0.9999|||||||Binomial Distribution|||Strain B02: Response rate was compared with whether greater than (\>) 50% of participants had fold rise \>=4 using right one-sided exact test based on binomial distribution and the corresponding p-values were calculated. p-value \< 0.025 was considered significant.||||>0.9999
72528034|NCT00808028|144586575|SUPERIORITY_OR_OTHER|||||||0.0036|||||||Binomial Distribution|||Strain B02: Response rate was compared with whether greater than (\>) 50% of participants had fold rise \>=4 using right one-sided exact test based on binomial distribution and the corresponding p-values were calculated. p-value \< 0.025 was considered significant.||||0.0036
72528035|NCT00808028|144586575|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Binomial Distribution|||Strain B02: Response rate was compared with whether greater than (\>) 50% of participants had fold rise \>=4 using right one-sided exact test based on binomial distribution and the corresponding p-values were calculated. p-value \< 0.025 was considered significant.||||<0.0001
72528036|NCT00808028|144586575|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Binomial Distribution|||Strain B02: Response rate was compared with whether greater than (\>) 50% of participants had fold rise \>=4 using right one-sided exact test based on binomial distribution and the corresponding p-values were calculated. p-value \< 0.025 was considered significant.||||<0.0001
72528037|NCT01797302|144586580|SUPERIORITY|||||||0.88||||||interaction term from model group\*time|Mixed Models Analysis|||||||0.88
72528038|NCT01797302|144586581|SUPERIORITY|||||||0.85||||||interaction term for group\*time|Mixed Models Analysis|||||||0.85
72528039|NCT01797302|144586582|SUPERIORITY|||||||0.61||||||interaction term group\*time from linear mixed model|Mixed Models Analysis|||||||0.61
72528040|NCT01797302|144586583|SUPERIORITY|||||||0.24||||||interaction term group\*time from linear mixed model|Mixed Models Analysis|||||||0.24
72528041|NCT01797302|144586584|SUPERIORITY|||||||0.0117||||||interaction term group\*time from linear mixed model|Mixed Models Analysis|||||||0.0117
72528042|NCT01797302|144586585|SUPERIORITY|||||||0.53||||||interaction term group\*time from linear mixed model|Mixed Models Analysis|||||||0.53
72528043|NCT01797302|144586586|SUPERIORITY|||||||0.0256||||||interaction term group\*time from linear mixed model|Mixed Models Analysis|||||||0.0256
72528044|NCT01797302|144586587|SUPERIORITY|||||||0.0945||||||interaction term group\*time from linear mixed model|Mixed Models Analysis|||||||0.0945
72528045|NCT01797302|144586588|SUPERIORITY|||||||0.12||||||interaction term group\*time from linear mixed model|Mixed Models Analysis|||||||0.12
72528046|NCT01797302|144586589|SUPERIORITY|||||||0.0094||||||interaction term group\*time from linear mixed model|Mixed Models Analysis|||||||0.0094
72528047|NCT00848172|144586659|SUPERIORITY_OR_OTHER||||||=|0.345||95.0|||||Mixed Models Analysis|||||||=0.345
72528048|NCT00848172|144586660|SUPERIORITY_OR_OTHER||||||=|0.031||95.0|||||Mixed Models Analysis|||||||=0.031
72528049|NCT00721136|144586664|OTHER|||||||||||||||||Continuous variables were expressed as mean ± standard deviation and analyzed using Student's t-test and Mann-Whitney U-test in cases of nonparametric distribution. Categorical variables were expressed as numbers or percentages and analyzed with two-tailed Fisher's exact test or χ2-test as appropriate. Data were analyzed on an intention-to-treat basis using STATA 10.1 (College Station, TX). A two-tailed alpha of 0.05 was considered statistically significant.|Continuous variables were expressed as mean ± standard deviation and analyzed using Student's t-test and Mann-Whitney U-test in cases of nonparametric distribution. Categorical variables were expressed as numbers or percentages and analyzed with two-tailed Fisher's exact test or χ2-test as appropriate. Data were analyzed on an intention-to-treat basis using STATA 10.1 (College Station, TX). A two-tailed alpha of 0.05 was considered statistically significant.|||
72528050|NCT01051856|144586729|SUPERIORITY_OR_OTHER_LEGACY|||||||0.35|TWO_SIDED||||||Chi-squared|||||||0.35
72528051|NCT02176226|144586732|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<.001
72528052|NCT02176226|144586733|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<.001
72528053|NCT03894501|144586755|SUPERIORITY|||||||0.048|||||||ANOVA|||||||.048
72528054|NCT03894501|144586756|SUPERIORITY|||||||0.037|||||||ANCOVA|||||||.037
72528055|NCT03894501|144586757|SUPERIORITY|||||||0.024|||||||ANCOVA|||||||.024
72528056|NCT03894501|144586758|SUPERIORITY|||||||0.005|||||||ANCOVA|||||||.005
72528057|NCT03894501|144586759|SUPERIORITY|||||||0.013|||||||ANOVA|||||||.013
72528058|NCT03894501|144586760|SUPERIORITY|||||||0.035|||||||ANOVA|||||||.035
72528059|NCT01412333|144586793|SUPERIORITY_OR_OTHER_LEGACY||Rate Ratio|0.532|||<|0.0001|TWO_SIDED|95.0|0.397|0.714|||Negative Binomial Model||Rate ratio was calculated as Ocrelizumab ARR/Interferon beta-1a 44 mcg SC ARR.|Adjusted by Geographical Region (US vs. Rest of World) and baseline EDSS (\<4.0 vs. \>=4.0).||0.714|0.397|< 0.0001
72528060|NCT01412333|144586794|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.63|||=|0.0169|TWO_SIDED|95.0|0.42|0.92|||Log Rank|||Time to onset of CDP at week 12||0.92|0.42|= 0.0169
72528061|NCT01412333|144586795|SUPERIORITY_OR_OTHER_LEGACY||Adjusted rate ratio|0.051|||<|0.0001||95.0|0.029|0.089|||Negative Binomial Model||Adjusted by baseline T1 Gd lesion (present or not), baseline EDSS (\<4.0 vs. \>=4.0) and geographical region (US vs. rest-of-world). Adjusted rate ratio was calculated as Ocrelizumab adjusted rate/Interferon beta-1a 44 mcg SC adjusted rate.|||0.089|0.029|< 0.0001
72528062|NCT01412333|144586796|SUPERIORITY_OR_OTHER_LEGACY||Adjusted rate ratio|0.171|||<|0.0001||95.0|0.13|0.225|||Negative Binomial Model||Adjusted by baseline T2 lesion count, baseline EDSS (\<4.0 vs. \>=4.0) and geographical region (US vs. rest-of-world). Adjusted rate ratio was calculated as Ocrelizumab adjusted rate/Interferon beta-1a 44 mcg SC adjusted rate.|||0.225|0.130|< 0.0001
72528063|NCT01412333|144586797|SUPERIORITY_OR_OTHER_LEGACY||Relative risk (stratified)|1.14|||=|0.4019|TWO_SIDED|95.0|0.84|1.56|||CMH Chi-Squared test (stratified)|Stratified by Geographical Region (US vs. Rest of World) and baseline EDSS (\<4.0 vs. \>=4.0).||||1.56|0.84|= 0.4019
72528064|NCT01412333|144586798|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.63|||=|0.037|TWO_SIDED|95.0|0.4|0.98|||Log Rank|||Time to onset of CDP at week 24||0.98|0.40|= 0.037
72528065|NCT01412333|144586799|SUPERIORITY_OR_OTHER_LEGACY||Adjusted rate ratio|0.357|||<|0.0001||95.0|0.272|0.47|||Negative Binomial Model||Adjusted by baseline T1-hypointense lesion count, baseline EDSS (\<4.0 vs. \>=4.0) and geographical region (US vs. rest-of-world). Adjusted rate ratio was calculated as Ocrelizumab adjusted rate/Interferon beta-1a 44 mcg SC adjusted rate.|||0.47|0.272|< 0.0001
72528066|NCT01412333|144586800|SUPERIORITY_OR_OTHER_LEGACY||Difference in Adjusted Means|0.107|STANDARD_ERROR_OF_MEAN|0.037|=|0.004|TWO_SIDED|95.0|0.034|0.18|||mixed-effect model of repeated measures|Estimates are from analysis based on mixed-effect model of repeated measures (MMRM) using unstructured covariance matrix.|Difference in adjusted means was calculated as Ocrelizumab adjusted mean at Week 96/ Interferon beta-1a 44 mcg SC adjusted mean at Week 96.|||0.180|0.034|= 0.004
72528067|NCT01412333|144586801|SUPERIORITY_OR_OTHER_LEGACY||Difference in Adjusted Means|0.112|STANDARD_ERROR_OF_MEAN|0.066|=|0.09|TWO_SIDED|95.0|-0.018|0.241|||mixed-effect model of repeated measures|Estimates are from analysis based on mixed-effect model of repeated measures (MMRM) using unstructured covariance matrix.|Difference in the rate of brain volume loss: 14.9%. Difference in adjusted means was calculated as Ocrelizumab adjusted mean at Week 96/ Interferon beta-1a 44 mcg SC adjusted mean at Week 96.|||0.241|-0.018|= 0.09
72528068|NCT01412333|144586802|SUPERIORITY_OR_OTHER_LEGACY||Difference in Adjusted Means|1.159|STANDARD_ERROR_OF_MEAN|0.564|=|0.0404|TWO_SIDED|95.0|0.051|2.268|||mixed-effect model of repeated measures|Estimates are from analysis based on mixed-effect model of repeated measures using unstructured covariance matrix.|Difference in adjusted means was calculated as Ocrelizumab adjusted mean at Week 96/ Interferon beta-1a 44 mcg SC adjusted mean at Week 96.|||2.268|0.051|= 0.0404
72528069|NCT01412333|144586803|SUPERIORITY_OR_OTHER_LEGACY||Relative risk (stratified)|1.81|||<|0.0001|TWO_SIDED|95.0|1.41|2.32|||CMH Chi-Squared test (stratified)|Analyzed using CMH test, stratified by Geographical Region (US vs. rest-of-world) and baseline EDSS (\<4.0 vs. \>=4.0).||||2.32|1.41|< 0.0001
72528070|NCT00750867|144586812|SUPERIORITY_OR_OTHER|||||||0.0128||||||The P-Value was obtained by comparing the UMSARS-I scores at final visit and at baseline.|ANOVA|||||||0.0128
72528071|NCT00750867|144586812|SUPERIORITY_OR_OTHER|||||||0.025||||||The P-Value was obtained by comparing the UMSARS-II scores at final visit and at baseline.|ANOVA|||||||0.025
72528072|NCT00779116|144586819|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0||||Statistical tests were performed atthe significance level of 5%, without multiplicity adjustment.|Mainland-Gart Test|The p-value was derived from Mainland-Gart Test applied to a 2 (treatment sequence) by 2 (preferred period) contingency table.||The Mainland-Gart test was applied to the preference rates in the subjects who showed a preference, to assess the difference in preference rates between RediTab and Zyrtec.||||<0.0001
72528073|NCT00266799|144586831|NON_INFERIORITY_OR_EQUIVALENCE|"Non-inferiority was tested using the upper limit of the 95% CI for the hazard ratio as quantitative estimate of the minimum effect of PLD relative to capecitabine. Margin for non-inferiority was set to 1.143, reflecting an acceptable difference in TTP of 0.75 months assuming an expected median TTP of up to 6 months with the comparator. If the estimate was below margin, PLD was to be considered non-inferior to capecitabine assuming sufficient sensitivity to detect the drug effects of~interest."|Hazard Ratio (HR)|1.08||||0.6686|TWO_SIDED|95.0|0.76|1.54|||Log Rank|||By Investigator Assessment of ITT Population||1.54|0.76|0.6686
72528074|NCT00266799|144586831|NON_INFERIORITY_OR_EQUIVALENCE|"Non-inferiority was tested using the upper limit of the 95% CI for the hazard ratio as quantitative estimate of the minimum effect of PLD relative to capecitabine. Margin for non-inferiority was set to 1.143, reflecting an acceptable difference in TTP of 0.75 months assuming an expected median TTP of up to 6 months with the comparator. If the estimate was below margin, PLD was to be considered non-inferior to capecitabine assuming sufficient sensitivity to detect the drug effects of~interest."|Hazard Ratio (HR)|1.15||||0.4472|TWO_SIDED|95.0|0.8|1.65|||Log Rank|||By RECIST Criteria of ITT Population||1.65|0.80|0.4472
72528075|NCT00266799|144586831|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.14||||0.5508|TWO_SIDED|95.0|0.74|1.77|||Log Rank|||By Investigator Assessment of TTP Population||1.77|0.74|0.5508
72528076|NCT00266799|144586831|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.21||||0.4088|TWO_SIDED|95.0|0.77|1.89|||Log Rank|||By RECIST Criteria of TTP Population||1.89|0.77|0.4088
72528077|NCT00266799|144586832|SUPERIORITY_OR_OTHER|||||||0.1726||95.0|||||Chi-squared|||By Investigator Assessment||||0.1726
72528078|NCT00266799|144586832|SUPERIORITY_OR_OTHER|||||||0.6541||95.0|||||Chi-squared|||By RECIST Criteria||||0.6541
72528079|NCT00266799|144586833|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.12||||0.5265|TWO_SIDED|95.0|0.79|1.58|||Log Rank|||||1.58|0.79|0.5265
72528080|NCT00266799|144586834|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.29||||0.0841||95.0|||||Log Rank|p-value also given for Hazard Ratio||||||0.0841
72528081|NCT00242710|144586843|SUPERIORITY_OR_OTHER||Least Squares (LS) Mean Difference|2.37|||<|0.001|TWO_SIDED|95.0|1.56|3.18|||ANCOVA|||An analysis of covariance (ANCOVA) model was used with treatment and center as main effects and baseline BMD and years since menopause as covariates.||3.18|1.56|<0.001
72528082|NCT00242710|144586843|SUPERIORITY_OR_OTHER||LS Mean Difference|2.36|||<|0.001|TWO_SIDED|95.0|1.56|3.17|||ANCOVA|||An ANCOVA model was used with treatment and center as main effects and baseline BMD and years since menopause as covariates.||3.17|1.56|<0.001
72528083|NCT00242710|144586843|SUPERIORITY_OR_OTHER||LS Mean Difference|3.78|||<|0.001|TWO_SIDED|95.0|2.81|4.76|||ANCOVA|||An ANCOVA model was used with treatment and center as main effects and baseline BMD and years since menopause as covariates.||4.76|2.81|<0.001
72528084|NCT00242710|144586845|SUPERIORITY_OR_OTHER||LS Mean Difference|1.61|||<|0.001|TWO_SIDED|95.0|0.97|2.24|||ANCOVA|||An ANCOVA model was used with treatment and center as main effects and baseline BMD and years since menopause as covariates.||2.24|0.97|<0.001
72528085|NCT00242710|144586845|SUPERIORITY_OR_OTHER||LS Mean Difference|1.82|||<|0.001|TWO_SIDED|95.0|1.19|2.46|||ANCOVA|||An ANCOVA model was used with treatment and center as main effects and baseline BMD and years since menopause as covariates.||2.46|1.19|<0.001
72528086|NCT00242710|144586845|SUPERIORITY_OR_OTHER||LS Mean Difference|2.46|||<|0.001|TWO_SIDED|95.0|1.69|3.23|||ANCOVA|||An ANCOVA model was used with treatment and center as main effects and baseline BMD and years since menopause as covariates.||3.23|1.69|<0.001
72528087|NCT00242710|144586846|SUPERIORITY_OR_OTHER||LS Mean Difference|0.66||||0.373|TWO_SIDED|95.0|-0.8|2.12|||ANCOVA|||Week 1-4: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.||2.12|-0.80|0.373
72528088|NCT00242710|144586846|SUPERIORITY_OR_OTHER||LS Mean Difference|0.35||||0.738|TWO_SIDED|95.0|-1.7|2.4|||ANCOVA|||Week 5-8: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.||2.40|-1.70|0.738
72528089|NCT00242710|144586846|SUPERIORITY_OR_OTHER||LS Mean Difference|0.65||||0.539|TWO_SIDED|95.0|-1.41|2.71|||ANCOVA|||Week 9-12: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.||2.71|-1.41|0.539
72528090|NCT00242710|144586846|SUPERIORITY_OR_OTHER||LS Mean Difference|1.09||||0.233|TWO_SIDED|95.0|-0.71|2.9|||ANCOVA|||Week 13-16: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.||2.90|-0.71|0.233
72528091|NCT00242710|144586846|SUPERIORITY_OR_OTHER||LS Mean Difference|0.5||||0.605|TWO_SIDED|95.0|-1.39|2.39|||ANCOVA|||Week 17-20: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.||2.39|-1.39|0.605
72528092|NCT00242710|144586846|SUPERIORITY_OR_OTHER||LS Mean Difference|1.23||||0.305|TWO_SIDED|95.0|-1.12|3.57|||ANCOVA|||Week 21-24: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.||3.57|-1.12|0.305
72528093|NCT00242710|144586846|SUPERIORITY_OR_OTHER||LS Mean Difference|1.22||||0.299|TWO_SIDED|95.0|-1.08|3.52|||ANCOVA|||Week 25-28: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.||3.52|-1.08|0.299
72528094|NCT00242710|144586846|SUPERIORITY_OR_OTHER||LS Mean Difference|1.62||||0.092|TWO_SIDED|95.0|-0.27|3.51|||ANCOVA|||Week 29-32: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.||3.51|-0.27|0.092
72528095|NCT00242710|144586846|SUPERIORITY_OR_OTHER||LS Mean Difference|1.55||||0.08|TWO_SIDED|95.0|-0.18|3.29|||ANCOVA|||Week 33-36: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.||3.29|-0.18|0.080
72528096|NCT00242710|144586846|SUPERIORITY_OR_OTHER||LS Mean Difference|1.04||||0.279|TWO_SIDED|95.0|-0.85|2.92|||ANCOVA|||Week 37-40: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.||2.92|-0.85|0.279
72528097|NCT00242710|144586846|SUPERIORITY_OR_OTHER||LS Mean Difference|1.13||||0.26|TWO_SIDED|95.0|-0.84|3.11|||ANCOVA|||Week 41-44: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.||3.11|-0.84|0.260
72528098|NCT00242710|144586846|SUPERIORITY_OR_OTHER||LS Mean Difference|0.51||||0.618|TWO_SIDED|95.0|-1.5|2.52|||ANCOVA|||Week 45-48: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.||2.52|-1.50|0.618
72528099|NCT00242710|144586846|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.41||||0.81|TWO_SIDED|95.0|-3.78|2.96|||ANCOVA|||Week 49-52: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.||2.96|-3.78|0.810
72528100|NCT00242710|144586846|SUPERIORITY_OR_OTHER||LS Mean Difference|0.34||||0.654|TWO_SIDED|95.0|-1.14|1.81|||ANCOVA|||Week 1-4: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.||1.81|-1.14|0.654
72528101|NCT00242710|144586846|SUPERIORITY_OR_OTHER||LS Mean Difference|0.22||||0.834|TWO_SIDED|95.0|-1.84|2.28|||ANCOVA|||Week 5-8: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.||2.28|-1.84|0.834
72528102|NCT00242710|144586846|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.34||||0.744|TWO_SIDED|95.0|-2.41|1.72|||ANCOVA|||Week 9-12: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.||1.72|-2.41|0.744
72528103|NCT00242710|144586846|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1||||0.909|TWO_SIDED|95.0|-1.7|1.91|||ANCOVA|||Week 13-16: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.||1.91|-1.70|0.909
72528104|NCT00242710|144586846|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.04||||0.963|TWO_SIDED|95.0|-1.94|1.85|||ANCOVA|||Week 17-20: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.||1.85|-1.94|0.963
72528105|NCT00242710|144586846|SUPERIORITY_OR_OTHER||LS Mean Difference|0.59||||0.625|TWO_SIDED|95.0|-1.77|2.94|||ANCOVA|||Week 21-24: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.||2.94|-1.77|0.625
72625360|NCT03309202|144780189|OTHER||Mean Difference (Final Values)|293.31|||||TWO_SIDED|90.0|186.04|462.44|||ANOVA|The natural log transformed parameter was used.|Estimate mean difference was derived from ratio (%) of adjusted geometric means of Test and Reference.Cohort 4 (Severe Hepatic Impairment) was Test and Cohort 1 (Without Hepatic Impairment) was Reference.|||462.44|186.04|
72625361|NCT03309202|144780190|OTHER||Mean Difference (Final Values)|169.84|||||TWO_SIDED|90.0|104.02|277.32|||ANOVA|The natural log transformed parameter was used.|Estimate mean difference was derived from ratio (%) of adjusted geometric means of Test and Reference.Cohort 2 (Mild Hepatic Impairment) was Test and Cohort 1 (Without Hepatic Impairment) was Reference.|||277.32|104.02|
72625362|NCT03309202|144780190|OTHER||Mean Difference (Final Values)|182.51|||||TWO_SIDED|90.0|111.78|298.02|||ANOVA|The natural log transformed parameter was used.|Estimate mean difference was derived from ratio (%) of adjusted geometric means of Test and Reference.Cohort 3 (Moderate Hepatic Impairment) was Test and Cohort 1 (Without Hepatic Impairment) was Reference.|||298.02|111.78|
72528106|NCT00242710|144586846|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.08||||0.947|TWO_SIDED|95.0|-2.39|2.23|||ANCOVA|||Week 25-28: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.||2.23|-2.39|0.947
72528107|NCT00242710|144586846|SUPERIORITY_OR_OTHER||LS Mean Difference|0.64||||0.505|TWO_SIDED|95.0|-1.25|2.53|||ANCOVA|||Week 29-32: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.||2.53|-1.25|0.505
72528108|NCT00242710|144586846|SUPERIORITY_OR_OTHER||LS Mean Difference|0.51||||0.564|TWO_SIDED|95.0|-1.23|2.25|||ANCOVA|||Week 33-36: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.||2.25|-1.23|0.564
72528109|NCT00242710|144586846|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.32||||0.739|TWO_SIDED|95.0|-2.21|1.57|||ANCOVA|||Week 37-40: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.||1.57|-2.21|0.739
72528110|NCT00242710|144586846|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3||||0.766|TWO_SIDED|95.0|-2.27|1.67|||ANCOVA|||Week 41-44: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.||1.67|-2.27|0.766
72528111|NCT00242710|144586846|SUPERIORITY_OR_OTHER||LS Mean Difference|0.09||||0.931|TWO_SIDED|95.0|-1.92|2.1|||ANCOVA|||Week 45-48: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.||2.10|-1.92|0.931
72625363|NCT03309202|144780190|OTHER||Mean Difference (Final Values)|266.29|||||TWO_SIDED|90.0|163.08|434.8|||ANOVA|The natural log transformed parameter was used.|Estimate mean difference was derived from ratio (%) of adjusted geometric means of Test and Reference.Cohort 4 (Severe Hepatic Impairment) was Test and Cohort 1 (Without Hepatic Impairment) was Reference.|||434.80|163.08|
72625364|NCT04734210|144780209|OTHER|Exploratory, descriptive analysis||||||0.2933||||||The difference in response rates between each of the SURF-200 formulations and vehicle was compared by Fisher's exact method.|Fisher Exact|The threshold for statistical significance is p=0.05.||Exploratory Phase 2 Study; approximately 120 subjects (approximately 40 subjects per each of the 3 treatment groups) were planned to be enrolled in the study. The sample size was based on medical judgment. No formal sample size calculation was performed, and the sample size was empirical. However, the sample size selected was considered sufficient to adequately characterize the general safety and efficacy profile of the study treatments.||||0.2933
72625365|NCT04734210|144780210|OTHER|Exploratory, descriptive analysis||||||0.1966||||||The difference in response rates between each of the SURF-200 formulations and vehicle was compared by Fisher's exact method.|Fisher Exact|The threshold for statistical significance is p=0.05.||Exploratory Phase 2 Study; approximately 120 subjects (approximately 40 subjects per each of the 3 treatment groups) were planned to be enrolled in the study. The sample size was based on medical judgment. No formal sample size calculation was performed, and the sample size was empirical. However, the sample size selected was considered sufficient to adequately characterize the general safety and efficacy profile of the study treatments.||||0.1966
72625366|NCT04734210|144780211|OTHER|Exploratory, descriptive analysis||||||0.0213||||||The difference in response rates between each of the SURF-200 formulations and vehicle was compared by Fisher's exact method.|Fisher Exact|The threshold for statistical significance is p=0.05.||Exploratory Phase 2 Study; approximately 120 subjects (approximately 40 subjects per each of the 3 treatment groups) were planned to be enrolled in the study. The sample size was based on medical judgment. No formal sample size calculation was performed, and the sample size was empirical. However, the sample size selected was considered sufficient to adequately characterize the general safety and efficacy profile of the study treatments.||||0.0213
72625367|NCT01690273|144780212|SUPERIORITY_OR_OTHER|||||||0.13|||||||Mixed Models Analysis|||||||0.13
72625368|NCT01690273|144780212|SUPERIORITY_OR_OTHER|||||||0.99|||||||Mixed Models Analysis|||||||0.99
72407340|NCT03706690|144323044|SUPERIORITY||Hazard Ratio (HR)|0.86||||0.275|TWO_SIDED|95.0|0.648|1.138|||Log Rank|The analysis was performed using the stratified log-rank test, adjusting for the level of PD-L1 expression and prior therapy (cCRT vs. sCRT).||For mITT set. The hazard ratio and CIs were calculated using a stratified Cox proportional hazards model, adjusting for the level of PD-L1 expression (PD-L1 \<1% vs. PD-L1 \>=1%) and prior therapy (cCRT vs. sCRT), with treatment as the only covariate and ties handled by Efron approach.||1.138|0.648|0.275
72528112|NCT00242710|144586846|SUPERIORITY_OR_OTHER||LS Mean Difference|0.19||||0.911|TWO_SIDED|95.0|-3.17|3.56|||ANCOVA|||Week 49-52: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.||3.56|-3.17|0.911
72528113|NCT00242710|144586846|SUPERIORITY_OR_OTHER||LS Mean Difference|2.61||||0.003|TWO_SIDED|95.0|0.92|4.3|||ANCOVA|||Week 1-4: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.||4.30|0.92|0.003
72528114|NCT00242710|144586846|SUPERIORITY_OR_OTHER||LS Mean Difference|4.18|||<|0.001|TWO_SIDED|95.0|1.79|6.58|||ANCOVA|||Week 5-8: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.||6.58|1.79|<0.001
72528115|NCT00242710|144586846|SUPERIORITY_OR_OTHER||LS Mean Difference|3.45||||0.005|TWO_SIDED|95.0|1.03|5.86|||ANCOVA|||Week 9-12: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.||5.86|1.03|0.005
72528116|NCT00242710|144586846|SUPERIORITY_OR_OTHER||LS Mean Difference|3.15||||0.004|TWO_SIDED|95.0|1.01|5.3|||ANCOVA|||Week 13-16: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.||5.30|1.01|0.004
72528117|NCT00242710|144586846|SUPERIORITY_OR_OTHER||LS Mean Difference|2.61||||0.023|TWO_SIDED|95.0|0.36|4.87|||ANCOVA|||Week 17-20: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.||4.87|0.36|0.023
72528118|NCT00242710|144586846|SUPERIORITY_OR_OTHER||LS Mean Difference|3.75||||0.008|TWO_SIDED|95.0|0.96|6.54|||ANCOVA|||Week 21-24: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.||6.54|0.96|0.008
72528119|NCT00242710|144586846|SUPERIORITY_OR_OTHER||LS Mean Difference|3.52||||0.012|TWO_SIDED|95.0|0.78|6.26|||ANCOVA|||Week 25-28: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.||6.26|0.78|0.012
72528120|NCT00242710|144586846|SUPERIORITY_OR_OTHER||LS Mean Difference|3.81|||<|0.001|TWO_SIDED|95.0|1.55|6.07|||ANCOVA|||Week 29-32: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.||6.07|1.55|<0.001
72528121|NCT00242710|144586846|SUPERIORITY_OR_OTHER||LS Mean Difference|3.75|||<|0.001|TWO_SIDED|95.0|1.68|5.83|||ANCOVA|||Week 33-36: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.||5.83|1.68|<0.001
72528122|NCT00242710|144586846|SUPERIORITY_OR_OTHER||LS Mean Difference|3.3||||0.004|TWO_SIDED|95.0|1.05|5.54|||ANCOVA|||Week 37-40: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.||5.54|1.05|0.004
72528123|NCT00242710|144586846|SUPERIORITY_OR_OTHER||LS Mean Difference|1.63||||0.175|TWO_SIDED|95.0|-0.73|3.99|||ANCOVA|||Week 41-44: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.||3.99|-0.73|0.175
72528124|NCT00242710|144586846|SUPERIORITY_OR_OTHER||LS Mean Difference|1.35||||0.27|TWO_SIDED|95.0|-1.05|3.75|||ANCOVA|||Week 45-48: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.||3.75|-1.05|0.270
72528125|NCT00242710|144586846|SUPERIORITY_OR_OTHER||LS Mean Difference|3.78||||0.077|TWO_SIDED|95.0|-0.41|7.97|||ANCOVA|||Week 49-52: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.||7.97|-0.41|0.077
72528126|NCT00242710|144586847|SUPERIORITY_OR_OTHER|||||||0.826|TWO_SIDED||||||Fisher Exact|||Week 1-4: The Fisher exact test was used for comparisons between groups.||||0.826
72528127|NCT00242710|144586847|SUPERIORITY_OR_OTHER|||||||0.534|TWO_SIDED||||||Fisher Exact|||Week 5-8: The Fisher exact test was used for comparisons between groups.||||0.534
72528128|NCT00242710|144586847|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Fisher Exact|||Week 9-12: The Fisher exact test was used for comparisons between groups.||||1.000
72528129|NCT00242710|144586847|SUPERIORITY_OR_OTHER|||||||0.516|TWO_SIDED||||||Fisher Exact|||Week 13-16: The Fisher exact test was used for comparisons between groups.||||0.516
72407341|NCT03706690|144323044|SUPERIORITY||Hazard Ratio (HR)|0.85||||0.241|TWO_SIDED|95.0|0.648|1.122|||Log Rank|The analysis was performed using the stratified log-rank test, adjusting for the level of PD-L1 expression and prior therapy (cCRT vs. sCRT).||For ITT set. The hazard ratio and CIs were calculated using a stratified Cox proportional hazards model, adjusting for the level of PD-L1 expression (PD-L1 \<1% vs. PD-L1 \>=1%) and prior therapy (cCRT vs. sCRT), with treatment as the only covariate and ties handled by Efron approach.||1.122|0.648|0.241
72528130|NCT00242710|144586847|SUPERIORITY_OR_OTHER|||||||0.446|TWO_SIDED||||||Fisher Exact|||Week 17-20: The Fisher exact test was used for comparisons between groups.||||0.446
72528131|NCT00242710|144586847|SUPERIORITY_OR_OTHER|||||||0.218|TWO_SIDED||||||Fisher Exact|||Week 21-24: The Fisher exact test was used for comparisons between groups.||||0.218
72528132|NCT00242710|144586847|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Fisher Exact|||Week 25-28: The Fisher exact test was used for comparisons between groups.||||1.000
72528133|NCT00242710|144586847|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Fisher Exact|||Week 29-32: The Fisher exact test was used for comparisons between groups.||||1.000
72528134|NCT00242710|144586847|SUPERIORITY_OR_OTHER|||||||0.733|TWO_SIDED||||||Fisher Exact|||Week 33-36: The Fisher exact test was used for comparisons between groups.||||0.733
72528135|NCT00242710|144586847|SUPERIORITY_OR_OTHER|||||||0.736|TWO_SIDED||||||Fisher Exact|||Week 37-40: The Fisher exact test was used for comparisons between groups.||||0.736
72528136|NCT00242710|144586847|SUPERIORITY_OR_OTHER|||||||0.449|TWO_SIDED||||||Fisher Exact|||Week 41-44: The Fisher exact test was used for comparisons between groups.||||0.449
72528137|NCT00242710|144586847|SUPERIORITY_OR_OTHER|||||||0.489|TWO_SIDED||||||Fisher Exact|||Week 45-48: The Fisher exact test was used for comparisons between groups.||||0.489
72528138|NCT00242710|144586847|SUPERIORITY_OR_OTHER|||||||0.163|TWO_SIDED||||||Fisher Exact|||Week 49-52: The Fisher exact test was used for comparisons between groups.||||0.163
72528139|NCT00242710|144586847|SUPERIORITY_OR_OTHER|||||||0.813|TWO_SIDED||||||Fisher Exact|||Week 1-4: The Fisher exact test was used for comparisons between groups.||||0.813
72528140|NCT00242710|144586847|SUPERIORITY_OR_OTHER|||||||0.777|TWO_SIDED||||||Fisher Exact|||Week 5-8: The Fisher exact test was used for comparisons between groups.||||0.777
72528141|NCT00242710|144586847|SUPERIORITY_OR_OTHER|||||||0.448|TWO_SIDED||||||Fisher Exact|||Week 9-12: The Fisher exact test was used for comparisons between groups.||||0.448
72528142|NCT00242710|144586847|SUPERIORITY_OR_OTHER|||||||0.507|TWO_SIDED||||||Fisher Exact|||Week 13-16: The Fisher exact test was used for comparisons between groups.||||0.507
72528143|NCT00242710|144586847|SUPERIORITY_OR_OTHER|||||||0.669|TWO_SIDED||||||Fisher Exact|||Week 17-20: The Fisher exact test was used for comparisons between groups.||||0.669
72528144|NCT00242710|144586847|SUPERIORITY_OR_OTHER|||||||0.281|TWO_SIDED||||||Fisher Exact|||Week 21-24: The Fisher exact test was used for comparisons between groups.||||0.281
72625369|NCT01690273|144780212|SUPERIORITY_OR_OTHER|||||||0.11|||||||Mixed Models Analysis|||||||0.11
72528145|NCT00242710|144586847|SUPERIORITY_OR_OTHER|||||||0.689|TWO_SIDED||||||Fisher Exact|||Week 25-28: The Fisher exact test was used for comparisons between groups.||||0.689
72528146|NCT00242710|144586847|SUPERIORITY_OR_OTHER|||||||0.437|TWO_SIDED||||||Fisher Exact|||Week 29-32: The Fisher exact test was used for comparisons between groups.||||0.437
72528147|NCT00242710|144586847|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Fisher Exact|||Week 33-36: The Fisher exact test was used for comparisons between groups.||||1.000
72528148|NCT00242710|144586847|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Fisher Exact|||Week 37-40: The Fisher exact test was used for comparisons between groups.||||1.000
72528149|NCT00242710|144586847|SUPERIORITY_OR_OTHER|||||||0.227|TWO_SIDED||||||Fisher Exact|||Week 41-44: The Fisher exact test was used for comparisons between groups.||||0.227
72528150|NCT00242710|144586847|SUPERIORITY_OR_OTHER|||||||0.758|TWO_SIDED||||||Fisher Exact|||Week 45-48: The Fisher exact test was used for comparisons between groups.||||0.758
72528151|NCT00242710|144586847|SUPERIORITY_OR_OTHER|||||||0.554|TWO_SIDED||||||Fisher Exact|||Week 49-52: The Fisher exact test was used for comparisons between groups.||||0.554
72528152|NCT00242710|144586847|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Fisher Exact|||Week 1-4: The Fisher exact test was used for comparisons between groups.||||<0.001
72528153|NCT00242710|144586847|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Fisher Exact|||Week 5-8: The Fisher exact test was used for comparisons between groups.||||<0.001
72528154|NCT00242710|144586847|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Fisher Exact|||Week 9-12: The Fisher exact test was used for comparisons between groups.||||<0.001
72528155|NCT00242710|144586847|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Fisher Exact|||Week 13-16: The Fisher exact test was used for comparisons between groups.||||<0.001
72528156|NCT00242710|144586847|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Fisher Exact|||Week 17-20: The Fisher exact test was used for comparisons between groups.||||<0.001
72528157|NCT00242710|144586847|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Fisher Exact|||Week 21-24: The Fisher exact test was used for comparisons between groups.||||<0.001
72528158|NCT00242710|144586847|SUPERIORITY_OR_OTHER|||||||0.008|TWO_SIDED||||||Fisher Exact|||Week 25-28: The Fisher exact test was used for comparisons between groups.||||0.008
72528159|NCT00242710|144586847|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Fisher Exact|||Week 29-32: The Fisher exact test was used for comparisons between groups.||||<0.001
72528160|NCT00242710|144586847|SUPERIORITY_OR_OTHER|||||||0.005|TWO_SIDED||||||Fisher Exact|||Week 33-36: The Fisher exact test was used for comparisons between groups.||||0.005
72528161|NCT00242710|144586847|SUPERIORITY_OR_OTHER|||||||0.008|TWO_SIDED||||||Fisher Exact|||Week 37-40: The Fisher exact test was used for comparisons between groups.||||0.008
72528162|NCT00242710|144586847|SUPERIORITY_OR_OTHER|||||||0.062|TWO_SIDED||||||Fisher Exact|||Week 41-44: The Fisher exact test was used for comparisons between groups.||||0.062
72528163|NCT00242710|144586847|SUPERIORITY_OR_OTHER|||||||0.007|TWO_SIDED||||||Fisher Exact|||Week 45-48: The Fisher exact test was used for comparisons between groups.||||0.007
72528164|NCT00242710|144586847|SUPERIORITY_OR_OTHER|||||||0.029|TWO_SIDED||||||Fisher Exact|||Week 49-52: The Fisher exact test was used for comparisons between groups.||||0.029
72625370|NCT01690273|144780212|SUPERIORITY_OR_OTHER|||||||0.9913|||||||Mixed Models Analysis|||||||0.9913
72625371|NCT01690273|144780212|SUPERIORITY_OR_OTHER|||||||0.0427|||||||Mixed Models Analysis|||||||0.0427
72625372|NCT01690273|144780212|SUPERIORITY_OR_OTHER|||||||0.1856|||||||Mixed Models Analysis|||||||0.1856
72625373|NCT01690273|144780213|SUPERIORITY_OR_OTHER|||||||0.04|||||||Mixed Models Analysis|||||||0.04
72571558|NCT03276221|144671784|SUPERIORITY||Slope|-0.5|STANDARD_ERROR_OF_MEAN|3.93||0.898|TWO_SIDED|||||The p-value was adjusted for multiple comparisons by the Bonferroni correction across outcomes for the multitasking test module. The a priori threshold for statistical significance was 0.0125.|Mixed Models Analysis|Estimates were obtained using generalized estimating equations (GEE) with robust standard errors obtained by the sandwich estimator.|The estimate is the mean difference in the median incongruency cost for the abstinence group above and beyond the monitoring group (positive values indicate higher costs for incongruent trials for the abstinence group).|The mean difference in scale scores between the abstinence and monitoring groups was estimated via a binomial model with a dummy-coded contrast (0 for monitoring, 1 for abstinence). The model adjusted for change at weeks 2, 3, and 4 of the study, and for a subject's scale scores at baseline.||||0.898
72528165|NCT00242710|144586849|SUPERIORITY_OR_OTHER||LS Mean Difference|3.25|||<|0.001|TWO_SIDED|95.0|1.92|4.58|||ANCOVA|||An ANCOVA model was used with treatment and center as main effects and baseline BMD and years since menopause as covariates.||4.58|1.92|<0.001
72528166|NCT00242710|144586849|SUPERIORITY_OR_OTHER||LS Mean Difference|3.14|||<|0.001|TWO_SIDED|95.0|1.83|4.46|||ANCOVA|||An ANCOVA model was used with treatment and center as main effects and baseline BMD and years since menopause as covariates.||4.46|1.83|<0.001
72528167|NCT00242710|144586849|SUPERIORITY_OR_OTHER||LS Mean Difference|4.68|||<|0.001|TWO_SIDED|95.0|3.13|6.23|||ANCOVA|||An ANCOVA model was used with treatment and center as main effects and baseline BMD and years since menopause as covariates.||6.23|3.13|<0.001
72528168|NCT00242710|144586850|SUPERIORITY_OR_OTHER||LS Mean Difference|1.83|||<|0.001|TWO_SIDED|95.0|0.8|2.87|||ANCOVA|||An ANCOVA model was used with treatment and center as main effects and baseline BMD and years since menopause as covariates.||2.87|0.80|<0.001
72528169|NCT00242710|144586850|SUPERIORITY_OR_OTHER||LS Mean Difference|1.94|||<|0.001|TWO_SIDED|95.0|0.92|2.97|||ANCOVA|||An ANCOVA model was used with treatment and center as main effects and baseline BMD and years since menopause as covariates.||2.97|0.92|<0.001
72528170|NCT00242710|144586850|SUPERIORITY_OR_OTHER||LS Mean Difference|2.38|||<|0.001|TWO_SIDED|95.0|1.17|3.59|||ANCOVA|||An ANCOVA model was used with treatment and center as main effects and baseline BMD and years since menopause as covariates.||3.59|1.17|<0.001
72528171|NCT00472043|144586890|SUPERIORITY||||||<|0.001||||||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||||||<0.001
72528172|NCT00852761|144586899|SUPERIORITY_OR_OTHER|||||||0.7298||95.0||||This is the result for the Day 3 analysis.|Chi-squared|||||||0.7298
72528173|NCT00852761|144586899|SUPERIORITY_OR_OTHER|||||||1||||||This is the result for the Day 8 analysis.|Chi-squared|||||||1.0000
72528174|NCT00852761|144586900|SUPERIORITY_OR_OTHER|||||||0.7298||95.0||||This is the result for the Day 3 analysis.|Chi-squared|||||||0.7298
72528175|NCT00852761|144586900|SUPERIORITY_OR_OTHER|||||||0.006||||||This is the result for the Day 8 analysis.|Chi-squared|||||||0.0060
72528176|NCT00852761|144586900|SUPERIORITY_OR_OTHER|||||||0.006||95.0||||This is the result for the Day 15 analysis.|Chi-squared|||||||0.0060
72528177|NCT00852761|144586901|SUPERIORITY_OR_OTHER|||||||0.0332||||||Data apply to Day 15.|Chi-squared|||||||0.0332
72528178|NCT00852761|144586903|SUPERIORITY_OR_OTHER|||||||0.3101||95.0||||This is the result for the Day 3 analysis.|Chi-squared|||||||0.3101
72528179|NCT00852761|144586903|SUPERIORITY_OR_OTHER|||||||0.7242||95.0||||This is the result for the Day 8 analysis.|Chi-squared|||||||0.7242
72528180|NCT00852761|144586903|SUPERIORITY_OR_OTHER|||||||0.0135||||||This is the p value for day 15|Chi-squared|||||||0.0135
72528181|NCT00852761|144586905|SUPERIORITY_OR_OTHER|||||||0.1449||||||P value at day 15.|Chi-squared|||||||0.1449
72576768|NCT00261443|144680647|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.19||||0.064|TWO_SIDED|95.0|-0.4|0.01||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 32 Comparison||0.01|-0.40|0.064
72625374|NCT01690273|144780213|SUPERIORITY_OR_OTHER|||||||0.0002|||||||Mixed Models Analysis|||||||0.0002
72528182|NCT00852761|144586905|SUPERIORITY_OR_OTHER|||||||0.1634||||||P value at day 3.|Chi-squared|||||||0.1634
72528183|NCT00852761|144586905|SUPERIORITY_OR_OTHER|||||||0.5454||||||P value at day 8.|Chi-squared|||||||0.5454
72528184|NCT00852761|144586906|SUPERIORITY_OR_OTHER|||||||0.6715||||||This is the p value for day 15.|Chi-squared|||||||0.6715
72528185|NCT00852761|144586906|SUPERIORITY_OR_OTHER|||||||0.7242||||||This is the p value for day 8.|Chi-squared|||||||0.7242
72528186|NCT00852761|144586906|SUPERIORITY_OR_OTHER|||||||0.6715||||||This is the p value for day 3.|Chi-squared|||||||0.6715
72528187|NCT00852761|144586907|SUPERIORITY_OR_OTHER|||||||0.4858||||||P value on day 8.|Chi-squared|||||||0.4858
72528188|NCT00852761|144586907|SUPERIORITY_OR_OTHER|||||||0.3001||||||P value on day 15.|Chi-squared|||||||0.3001
72528189|NCT00877890|144586921|NON_INFERIORITY_OR_EQUIVALENCE|The choice of a 0.4% noninferiority margin was resulted from the considerations of expected clinical benefit of BYETTA in this study based on clinical data evaluating exenatide once weekly and BYETTA, regulatory guidance, published literature, and statistical considerations.|Least Squares Mean Difference|-0.67|STANDARD_ERROR_OF_MEAN|0.138|<|0.0001|TWO_SIDED|95.0|-0.94|-0.39|||ANOVA|Analysis of variance (ANOVA) model includes treatment, baseline HbA1c stratum (\<9% or \>=9%), and concomitant SU use at screening as factors.||Superiority of exenatide once weekly to BYETTA if the upper limit of the 2-sided 95% CI for treatment difference (exenatide once weekly minus BYETTA) is \<0; noninferiority if this upper limit is \<0.4%. Power: Assuming 15% dropout rate with 206 subjects will complete the study. This sample size would provide 90% power for non-inferiority test with assumption of greater reduction (0.1%) in exenatide once weekly and a common standard deviation of 1.1%.||-0.39|-0.94|<.0001
72625375|NCT01690273|144780213|SUPERIORITY_OR_OTHER|||||||0.0002|||||||Mixed Models Analysis|||||||0.0002
72625376|NCT01690273|144780213|SUPERIORITY_OR_OTHER|||||||1|||||||Mixed Models Analysis|||||||1
72625377|NCT01690273|144780213|SUPERIORITY_OR_OTHER|||||||0.935|||||||Mixed Models Analysis|||||||0.935
72625378|NCT01690273|144780213|SUPERIORITY_OR_OTHER|||||||0.876|||||||Mixed Models Analysis|||||||0.876
72625379|NCT01690273|144780214|SUPERIORITY_OR_OTHER|||||||0.004|||||||Mixed Models Analysis|||||||0.004
72625380|NCT01690273|144780214|SUPERIORITY_OR_OTHER|||||||0.87|||||||Mixed Models Analysis|||||||0.87
72625381|NCT01690273|144780214|SUPERIORITY_OR_OTHER|||||||0.83|||||||Mixed Models Analysis|||||||0.83
72571559|NCT03276221|144671785|SUPERIORITY||Slope|16.54|STANDARD_ERROR_OF_MEAN|9.05||0.068|TWO_SIDED|||||The p-value was adjusted for multiple comparisons by the Bonferroni correction across outcomes for the multitasking test module. The a priori threshold for statistical significance was 0.0125.|Mixed Models Analysis|Estimates were obtained using generalized estimating equations (GEE) with robust standard errors obtained by the sandwich estimator.|The estimate is the mean difference in the multitasking cost for the abstinence group above and beyond the monitoring group (positive values indicate higher costs for multitasking trials for the abstinence group).|The mean difference in scale scores between the abstinence and monitoring groups was estimated via a binomial model with a dummy-coded contrast (0 for monitoring, 1 for abstinence). The model adjusted for change at weeks 2, 3, and 4 of the study, and for a subject's scale scores at baseline.||||0.068
72571560|NCT03276221|144671786|SUPERIORITY||Slope|0.15|STANDARD_ERROR_OF_MEAN|0.1||0.15|TWO_SIDED|||||The p-value was adjusted for multiple comparisons by the Bonferroni correction across outcomes for the one touch stockings of Cambridge module. The a priori threshold for statistical significance was 0.025.|Mixed Models Analysis|Estimates were obtained using generalized estimating equations (GEE) with robust standard errors obtained by the sandwich estimator.|The estimate is the mean difference in the log probability of making a correct response for the abstinence group above and beyond the monitoring group (positive values indicate higher accuracy for the abstinence group).|The mean difference in scale scores between the abstinence and monitoring groups was estimated via a binomial model with a dummy-coded contrast (0 for monitoring, 1 for abstinence). The model adjusted for change at weeks 2, 3, and 4 of the study, and for a subject's scale scores at baseline.||||0.150
72571561|NCT03276221|144671787|SUPERIORITY||Slope|179.11|STANDARD_ERROR_OF_MEAN|281.76||0.525|TWO_SIDED|||||The p-value was adjusted for multiple comparisons by the Bonferroni correction across outcomes for the one touch stockings of Cambridge module. The a priori threshold for statistical significance was 0.025.|Mixed Models Analysis|Estimates were obtained using generalized estimating equations (GEE) with robust standard errors obtained by the sandwich estimator.|The estimate is the mean difference in the log probability of making an error for the abstinence group above and beyond the monitoring group (positive values indicate higher error commission for the abstinence group).|The mean difference in scale scores between the abstinence and monitoring groups was estimated via a binomial model with a dummy-coded contrast (0 for monitoring, 1 for abstinence). The model adjusted for change at weeks 2, 3, and 4 of the study, and for a subject's scale scores at baseline.||||0.525
72571562|NCT03276221|144671788|SUPERIORITY||Slope|-10.86|STANDARD_ERROR_OF_MEAN|5.24||0.038|TWO_SIDED|||||The p-value was adjusted for multiple comparisons by the Bonferroni correction across outcomes for the stop signal task module. The a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|Estimates were obtained using generalized estimating equations (GEE) with robust standard errors obtained by the sandwich estimator.|The estimate is the mean difference in the inhibition latency for the abstinence group above and beyond the monitoring group (positive values indicate slower inhibition for the abstinence group).|The mean difference in scale scores between the abstinence and monitoring groups was estimated via a binomial model with a dummy-coded contrast (0 for monitoring, 1 for abstinence). The model adjusted for change at weeks 2, 3, and 4 of the study, and for a subject's scale scores at baseline.||||0.038
72625382|NCT01690273|144780214|SUPERIORITY_OR_OTHER|||||||0.989|||||||Mixed Models Analysis|||||||0.989
72528190|NCT00877890|144586922|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Multiplicity adjustment using Hochberg procedure for the 3 key secondary endpoints (i.e., percent to achieving HbA1c goal of \<7%, change in fasting glucose, and percent of achieving fasting plasma glucose goal of \<=126 mg/dL) was performed.|Cochran-Mantel-Haenszel|||Analysis: Percentages of subjects achieving HbA1c target value of \<7% at Week 24 were compared between treatments using a Cochran-Mantel-Haenszel (CMH) test, in which baseline HbA1c stratum (\<9% or \>=9%) and concomitant SU use at screening served as the stratification factors. Null hypothesis: no difference between treatments in percentage of subjects achieving HbA1c target. Power: based on the primary measurement.||||<.0001
72528191|NCT00877890|144586923|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Analysis: Percentages of subjects achieving HbA1c target values of \<=6.5% at Week 24 were compared between treatments using a CMH test, in which baseline HbA1c stratum (\<9% or \>=9%) and concomitant SU use at screening served as the stratification factors. Null hypothesis: no difference between treatments in percentage of subjects achieving HbA1c target. Power: based on the primary measurement.||||<.0001
72528192|NCT00877890|144586924|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-20.4|STANDARD_ERROR_OF_MEAN|5.57||0.0006|TWO_SIDED|95.0|-31.4|-9.5||Multiplicity adjustment using Hochberg procedure for the 3 key secondary endpoints (i.e., percent to achieving HbA1c goal of \<7%, change in fasting glucose, and percent of achieving fasting plasma glucose goal of \<=126 mg/dL) was performed.|ANCOVA|||Analysis: Change in fasting plasma glucose from baseline (Day 1) to Week 24 was analyzed by an ANCOVA model including treatment, baseline HbA1c stratum (\<9% or \>=9%), and concomitant SU use at screening as factors, and baseline value of the fasting plasma glucose as a covariate. Null hypothesis: no difference between treatments in change from baseline fasting plasma glucose. Power: based on the primary measurement.||-9.5|-31.4|0.0006
72571563|NCT03276221|144671789|SUPERIORITY||Slope|-0.1|STANDARD_ERROR_OF_MEAN|0.17||0.576|TWO_SIDED|||||The p-value was adjusted for multiple comparisons by the Bonferroni correction across outcomes for the spatial working memory module. The a priori threshold for statistical significance was 0.025.|Mixed Models Analysis|Estimates were obtained using generalized estimating equations (GEE) with robust standard errors obtained by the sandwich estimator.|The estimate is the mean difference in the log probability of making an error for the abstinence group above and beyond the monitoring group (positive values indicate higher error commission for the abstinence group).|The mean difference in scale scores between the abstinence and monitoring groups was estimated via a binomial model with a dummy-coded contrast (0 for monitoring, 1 for abstinence). The model adjusted for change at weeks 2, 3, and 4 of the study, and for a subject's scale scores at baseline.||||0.576
72625383|NCT01690273|144780214|SUPERIORITY_OR_OTHER|||||||0.022|||||||Mixed Models Analysis|||||||0.022
72625384|NCT01690273|144780214|SUPERIORITY_OR_OTHER|||||||0.119|||||||Mixed Models Analysis|||||||0.119
72625385|NCT01690273|144780215|SUPERIORITY_OR_OTHER|||||||0.09|||||||Mixed Models Analysis|||||||0.09
72625386|NCT01690273|144780215|SUPERIORITY_OR_OTHER|||||||0.99|||||||Mixed Models Analysis|||||||0.99
72625387|NCT01690273|144780215|SUPERIORITY_OR_OTHER|||||||0.94|||||||Mixed Models Analysis|||||||0.94
72528193|NCT00877890|144586925|SUPERIORITY_OR_OTHER|||||||0.0008|TWO_SIDED|||||Multiplicity adjustment using Hochberg procedure for the 3 key secondary endpoints (i.e., percent to achieving HbA1c goal of \<7%, change in fasting glucose, and percent of achieving fasting plasma glucose goal of \<=126 mg/dL) was performed.|Cochran-Mantel-Haenszel|||Analysis: Percentages of subjects achieving fasting plasma glucose target of \<=126 mg/dL at Week 24 were compared between treatments using a CMH test, in which baseline HbA1c stratum (\<9% or \>=9%) and concomitant SU use at screening served as the stratification factors. Null hypothesis: no difference between treatments in percentage of subjects achieving fasting plasma glucose target. Power: based on the primary measurement.||||0.0008
72528194|NCT00877890|144586926|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.95|STANDARD_ERROR_OF_MEAN|0.487||0.0514|TWO_SIDED|95.0|-1.91|0.01|||ANCOVA|||Analysis: Change in body weight from baseline (Day 1) to Week 24 was analyzed by an ANCOVA model including treatment, baseline HbA1c stratum (\<9% or \>=9%), and concomitant SU use at screening as factors, and baseline value of the body weight as a covariate. Null hypothesis: no difference between treatments in change from baseline body weight. Power: based on the primary measurement.||0.01|-1.91|0.0514
72528195|NCT00877890|144586927|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-1.8|STANDARD_ERROR_OF_MEAN|1.5||0.2367|TWO_SIDED|95.0|-4.7|1.2|||ANCOVA|||Analysis: Change in systolic blood pressure from baseline (Day 1) to Week 24 was analyzed by an ANCOVA model including treatment, baseline HbA1c stratum (\<9% or \>=9%), and concomitant SU use at screening as factors, and baseline value of the systolic blood pressure as a covariate. Null hypothesis: no difference between treatments in change from baseline systolic blood pressure. Power: based on the primary measurement.||1.2|-4.7|0.2367
72528196|NCT00877890|144586928|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|0.98||0.7717|TWO_SIDED|95.0|-1.7|2.2|||ANCOVA|||Analysis: Change in diastolic blood pressure from baseline (Day 1) to Week 24 was analyzed by an ANCOVA model including treatment, baseline HbA1c stratum (\<9% or \>=9%), and concomitant SU use at screening as factors, and baseline value of the diastolic blood pressure as a covariate. Null hypothesis: no difference between treatments in change from baseline diastolic blood pressure. Power: based on the primary measurement.||2.2|-1.7|0.7717
72528197|NCT00877890|144586929|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-16.0|STANDARD_ERROR_OF_MEAN|3.5|<|0.0001|TWO_SIDED|95.0|-22.9|-9.1|||ANCOVA|||Analysis: Change in total cholesterol from baseline (Day 1) to Week 24 was analyzed by an ANCOVA model including treatment, baseline HbA1c stratum (\<9% or \>=9%), and concomitant SU use at screening as factors, and baseline value of the total cholesterol as a covariate. Null hypothesis: no difference between treatments in change from baseline total cholesterol. Power: based on the primary measurement.||-9.1|-22.9|<.0001
72528198|NCT00877890|144586930|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|0.8||0.1251|TWO_SIDED|95.0|-2.8|0.3|||ANCOVA|||Analysis: Change in HDL from baseline (Day 1) to Week 24 was analyzed by an ANCOVA model including treatment, baseline HbA1c stratum (\<9% or \>=9%), and concomitant SU use at screening as factors, and baseline value of the HDL as a covariate. Null hypothesis: no difference between treatments in change from baseline HDL. Power: based on the primary measurement.||0.3|-2.8|0.1251
72528199|NCT00877890|144586931|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean Ratio|0.95|STANDARD_ERROR_OF_MEAN|0.043||0.2558|TWO_SIDED|95.0|0.87|1.04|||ANCOVA|||Analysis: Triglycerides data were logarithm-transformed and the change at Week 30 to baseline (Day 1) , expressed as the ratio, was analyzed by an ANCOVA model including treatment, baseline HbA1c stratum (\<9% or \>=9%), and concomitant SU use at screening as factors, and baseline value of the triglycerides as a covariate. Null hypothesis: no difference between treatments in change from baseline triglycerides. Power: based on the primary measurement.||1.04|0.87|0.2558
72528200|NCT00606021|144586942|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.76||||0.1815|TWO_SIDED|95.0|0.42|1.37||The significant level for the primary outcome measure of progression free survival during maintenance phase is one-sided 0.2.|Regression, Cox|Stratified Cox regression model is used for hazard ratio estimate. Stratification factor: response status prior to randomization.||||1.37|0.42|0.1815
72571564|NCT03276221|144671790|SUPERIORITY||Slope|-0.15|STANDARD_ERROR_OF_MEAN|0.15||0.296|TWO_SIDED|||||The p-value was adjusted for multiple comparisons by the Bonferroni correction across outcomes for the spatial working memory module. The a priori threshold for statistical significance was 0.025.|Mixed Models Analysis|Estimates were obtained using generalized estimating equations (GEE) with robust standard errors obtained by the sandwich estimator.|The estimate is the mean difference in the log probability of trials with strategic responding for the abstinence group above and beyond the monitoring group (positive values indicate higher rates of strategic responding for the abstinence group).|The mean difference in scale scores between the abstinence and monitoring groups was estimated via a binomial model with a dummy-coded contrast (0 for monitoring, 1 for abstinence). The model adjusted for change at weeks 2, 3, and 4 of the study, and for a subject's scale scores at baseline.||||0.296
72576769|NCT00261443|144680647|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.25||||0.017|TWO_SIDED|95.0|-0.46|-0.05||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 36 Comparison||-0.05|-0.46|0.017
72625388|NCT01690273|144780215|SUPERIORITY_OR_OTHER|||||||0.213|||||||Mixed Models Analysis|||||||0.213
72528201|NCT00606021|144586943|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.71||||0.1233|TWO_SIDED|95.0|0.4|1.26||The significant level for the secondary outcome measure of progression free survival during overall period is one-sided 0.2.|Regression, Cox|Stratified Cox regression model is used for hazard ratio estimate. Stratification factor: response status prior to randomization.||||1.26|0.40|0.1233
72528202|NCT00606021|144586944|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.13||||0.7239|TWO_SIDED|95.0|0.56|2.28||The significant level for the secondary outcome measure overall survival during maintenance period is two-sided 0.05.|Regression, Cox|Stratified Cox regression model is used for hazard ratio estimate. Stratification factor: response status prior to randomization.||||2.28|0.56|0.7239
72625389|NCT01690273|144780215|SUPERIORITY_OR_OTHER|||||||0.007|||||||Mixed Models Analysis|||||||0.007
72625390|NCT01690273|144780215|SUPERIORITY_OR_OTHER|||||||0.9|||||||Mixed Models Analysis|||||||0.900
72625391|NCT01690273|144780216|SUPERIORITY_OR_OTHER|||||||0.003|||||||Mixed Models Analysis|||||||0.003
72625392|NCT01690273|144780216|SUPERIORITY_OR_OTHER|||||||0.99|||||||Mixed Models Analysis|||||||0.99
72407342|NCT03706690|144323045|SUPERIORITY||Hazard Ratio (HR)|1.06||||0.769|TWO_SIDED|95.0|0.726|1.578|||Log Rank|The analysis was performed using the stratified log-rank test, adjusting for the level of PD-L1 expression and prior therapy (cCRT vs. sCRT).||For mITT set. The hazard ratio and CIs were calculated using a stratified Cox proportional hazards model, adjusting for the level of PD-L1 expression (PD-L1 \<1% vs. PD-L1 \>=1%) and prior therapy (cCRT vs. sCRT), with treatment as the only covariate and ties handled by Efron approach.||1.578|0.726|0.769
72407343|NCT03706690|144323045|SUPERIORITY||Hazard Ratio (HR)|1.05||||0.812|TWO_SIDED|95.0|0.726|1.539|||Log Rank|The analysis was performed using the stratified log-rank test, adjusting for the level of PD-L1 expression and prior therapy (cCRT vs. sCRT).||For ITT set. The hazard ratio and CIs were calculated using a stratified Cox proportional hazards model, adjusting for the level of PD-L1 expression (PD-L1 \<1% vs. PD-L1 \>=1%) and prior therapy (cCRT vs. sCRT), with treatment as the only covariate and ties handled by Efron approach.||1.539|0.726|0.812
72407344|NCT03467425|144323094|SUPERIORITY||Odds Ratio (OR)|1.31|||<|0.001|TWO_SIDED|95.0|1.13|1.51||Analysis was performed using logistic regression model with covariates of treatment group, Baseline CAT score, number of exacerbations in the prior year, actual prior medication use strata and country.|Regression, Logistic||Statistical comparison is presented for combined data of responders, non-responders and those with imputed CAT score at Week 24.|||1.51|1.13|<0.001
72407345|NCT03467425|144323095|SUPERIORITY||Mean Difference (Net)|0.05|STANDARD_ERROR_OF_MEAN|0.0121|<|0.001|TWO_SIDED|95.0|0.026|0.073|||ANCOVA||Analysis was performed using an ANCOVA with covariates of treatment group, Baseline FEV1, actual prior medication use strata, country and timing of spirometry.|||0.073|0.026|<0.001
72407346|NCT03467425|144323096|SUPERIORITY||Odds Ratio (OR)|1.99||||0.103|TWO_SIDED|95.0|0.87|4.53|||Regression, Logistic||Analysis was performed using logistic regression model with covariates of treatment group, actual prior medication use strata and country.|||4.53|0.87|0.103
72407347|NCT02318693|144323097|SUPERIORITY_OR_OTHER||LS Means Difference|-8.8||||0.245|TWO_SIDED|95.0|-23.8|6.2|||constrained longitudinal analysis model|Model included terms for treatment, time and time-by-treatment interaction with a constraint that mean baseline is the same for both treatment groups.||The comparison was conducted at the α=0.05 (2-sided) significance level.||6.2|-23.8|0.245
72528203|NCT00606021|144586945|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.18||||0.6376|TWO_SIDED|95.0|0.59|2.38||The significant level for the secondary outcome measure overall survival during overall period is two-sided 0.05.|Regression, Cox|Stratified Cox regression model is used for hazard ratio estimate. Stratification factor: response status prior to randomization.||||2.38|0.59|0.6376
72528204|NCT03049852|144586948|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
72528205|NCT03049852|144586950|SUPERIORITY||Mean Difference (Final Values)|0.27||||0.007|TWO_SIDED||||||ANOVA|||||||0.007
72625393|NCT01690273|144780216|SUPERIORITY_OR_OTHER|||||||0.69|||||||Mixed Models Analysis|||||||0.69
72407348|NCT02318693|144323098|SUPERIORITY_OR_OTHER||LS Means Difference|-5.9||||0.029|TWO_SIDED|95.0|-11.3|-0.6|||constrained longitudinal analysis model|Model included terms for treatment, time and time-by-treatment interaction with a constraint that mean baseline is the same for both treatment groups.||The comparison was conducted at the α=0.05 (2-sided) significance level.||-0.6|-11.3|0.029
72528206|NCT00498706|144586961|SUPERIORITY_OR_OTHER||t value|-2.95||||0.003||95.0|||||t-test, 2 sided|||||||0.003
72407349|NCT02318693|144323099|SUPERIORITY_OR_OTHER||LS Means Difference|-12.8||||0.041|TWO_SIDED|95.0|-25.1|-0.5|||constrained longitudinal analysis model|Model included terms for treatment, time and time-by-treatment interaction with a constraint that mean baseline is the same for both treatment groups.||Comparison: Change from Baseline in Maximum Incremental Postprandial Glucose Levels at Breakfast. The comparison was conducted at the α=0.05 (2-sided) significance level.||-0.5|-25.1|0.041
72407350|NCT02318693|144323099|SUPERIORITY_OR_OTHER||LS Means Difference|-14.3||||0.043|TWO_SIDED|95.0|-28.1|-0.5|||constrained longitudinal analysis model|Model included terms for treatment, time and time-by-treatment interaction with a constraint that mean baseline is the same for both treatment groups.||Comparison: Change from Baseline in Maximum Incremental Postprandial Glucose Levels at Lunch. The comparison was conducted at the α=0.05 (2-sided) significance level.||-0.5|-28.1|0.043
72528207|NCT00498706|144586962|SUPERIORITY_OR_OTHER||Chi-square|5.83||||0.02||95.0|||||Chi-squared|||||||0.02
72528208|NCT00498706|144586962|SUPERIORITY_OR_OTHER||Chi-square|7.75||||0.006||95.0|||||Chi-squared||Attrition before week 5 was significantly lower in T-CBT than in face-to-face CBT.|||||.006
72528209|NCT00498706|144586964|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority is established by showing that the true difference between 2 treatment arms is likely to be smaller than a prespecified noninferiority margin that separates clinically important from clinically negligible (acceptable) differences.|Mean Difference (Net)|-0.09|STANDARD_DEVIATION|1.26||0.89|TWO_SIDED|95.0|-1.35|1.17|||Mixed Models Analysis|||Longitudinal depression scores were modeled with repeated-measures linear regression models.Time was treated as a categorical variable to account for nonlinear effects of time, and an unstructured covariance matrix was assumed.||1.17|-1.35|0.89
72528210|NCT00498706|144586965|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority is established by showing that the true difference between 2 treatment arms is likely to be smaller than a prespecified noninferiority margin that separates clinically important from clinically negligible (acceptable) differences.|Mean Difference (Net)|1.07|STANDARD_DEVIATION|1.695||0.22|TWO_SIDED|95.0|-0.63|2.76|||Mixed Models Analysis|||Longitudinal depression scores were modeled with repeated-measures linear regression models.Time was treated as a categorical variable to account for nonlinear effects of time, and an unstructured covariance matrix was assumed.||2.76|-0.63|0.22
72625394|NCT01690273|144780216|SUPERIORITY_OR_OTHER|||||||0.874|||||||Mixed Models Analysis|||||||0.874
72625395|NCT01690273|144780216|SUPERIORITY_OR_OTHER|||||||0.057|||||||Mixed Models Analysis|||||||0.057
72625396|NCT01690273|144780216|SUPERIORITY_OR_OTHER|||||||0.526|||||||Mixed Models Analysis|||||||0.526
72625397|NCT01690273|144780217|SUPERIORITY_OR_OTHER|||||||0.853|||||||Mixed Models Analysis|||||||0.853
72625398|NCT01690273|144780217|SUPERIORITY_OR_OTHER|||||||0.016|||||||Mixed Models Analysis|||||||0.016
72625399|NCT01690273|144780217|SUPERIORITY_OR_OTHER|||||||0|||||||Mixed Models Analysis|||||||0.000
72625400|NCT01690273|144780217|SUPERIORITY_OR_OTHER|||||||0.889|||||||Mixed Models Analysis|||||||0.889
72625401|NCT01690273|144780217|SUPERIORITY_OR_OTHER|||||||0.098|||||||Mixed Models Analysis|||||||0.098
72625402|NCT01690273|144780217|SUPERIORITY_OR_OTHER|||||||0.645|||||||Mixed Models Analysis|||||||0.645
72571565|NCT03276221|144671791|SUPERIORITY||Slope|0.0|STANDARD_ERROR_OF_MEAN|0.01||0.65|TWO_SIDED|||||The p-value was adjusted for multiple comparisons by the Bonferroni correction across outcomes for the rapid visual information processing module. The a priori threshold for statistical significance was 0.025.|Mixed Models Analysis|Estimates were obtained using generalized estimating equations (GEE) with robust standard errors obtained by the sandwich estimator.|The estimate is the mean difference in the discriminability measure for the abstinence group above and beyond the monitoring group (positive values indicate higher discriminability rates for the abstinence group).|The mean difference in scale scores between the abstinence and monitoring groups was estimated via a binomial model with a dummy-coded contrast (0 for monitoring, 1 for abstinence). The model adjusted for change at weeks 2, 3, and 4 of the study, and for a subject's scale scores at baseline.||||0.650
72407351|NCT02318693|144323099|SUPERIORITY_OR_OTHER||LS Means Difference|5.1||||0.509|TWO_SIDED|95.0|-10.3|20.4|||constrained longitudinal analysis model|Model included terms for treatment, time and time-by-treatment interaction with a constraint that mean baseline is the same for both treatment groups.||Comparison: Change from Baseline in Maximum Incremental Postprandial Glucose Levels at Dinner. The comparison was conducted at the α=0.05 (2-sided) significance level.||20.4|-10.3|0.509
72407352|NCT02318693|144323100|SUPERIORITY_OR_OTHER||LS Means Difference|15.7||||0.02|TWO_SIDED|95.0|2.5|28.8|||constrained longitudinal analysis model|Model included terms for treatment, time and time-by-treatment interaction with a constraint that mean baseline is the same for both treatment groups.||The comparison was conducted at the α=0.05 (2-sided) significance level.||28.8|2.5|0.020
72407353|NCT02318693|144323101|SUPERIORITY_OR_OTHER||LS Means Difference|-1.1||||0.134|TWO_SIDED|95.0|-2.5|0.3|||constrained longitudinal analysis model|||Comparison: Change in Baseline in Percentage of Hypoglycemic Values \< 70 mg/dL. The comparison was conducted at the α=0.05 (2-sided) significance level.||0.3|-2.5|0.134
72528211|NCT01928186|144587016|OTHER|||||||0.51|||||||Fisher Exact|the mid-P adjustment to Fisher's exact test||Association between response assessed by Ki-67 protein staining (i.e. \< 10% positive cells in the surgical sample) and by the influx constant Ki decline (i.e. 30 % or larger decline between the baseline and post-therapy FLT PET) was analyzed using the mid-P adjustment to Fisher's exact test.||||0.51
72528212|NCT04540627|144587030|SUPERIORITY|||||||0.5802|||||||Wilcoxon (Mann-Whitney)|||||||0.5802
72528213|NCT04540627|144587031|SUPERIORITY|||||||0.4868|||||||Wilcoxon (Mann-Whitney)|||||||0.4868
72528214|NCT04540627|144587032|SUPERIORITY|||||||0.2681|||||||Wilcoxon (Mann-Whitney)|||||||0.2681
72528215|NCT04540627|144587033|SUPERIORITY|||||||0.2431|||||||Wilcoxon (Mann-Whitney)|||||||0.2431
72528216|NCT04540627|144587038|SUPERIORITY|||||||0.4868|||||||Wilcoxon (Mann-Whitney)|||||||0.4868
72528217|NCT04540627|144587040|SUPERIORITY|||||||0.0403|||||||Wilcoxon (Mann-Whitney)|||||||0.0403
72528218|NCT01265719|144587058|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.33|STANDARD_ERROR_OF_MEAN|0.2||0.1126|TWO_SIDED|95.0|-0.09|0.74|||ANCOVA||Change from baseline to last available observation in BCVA was analyzed using an ANCOVA model with fixed effect for treatment group with baseline BCVA value as covariate.|\<5 years||0.74|-0.09|0.1126
72528219|NCT01265719|144587058|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.03|STANDARD_ERROR_OF_MEAN|0.04||0.484|TWO_SIDED|95.0|-0.12|0.06|||ANCOVA||Change from baseline to last available observation in BCVA was analyzed using an ANCOVA model with fixed effect for treatment group with baseline BCVA value as covariate.|5 to \<18 years||0.06|-0.12|0.4840
72407354|NCT02318693|144323101|SUPERIORITY_OR_OTHER||LS Means Difference|-0.6||||0.226|TWO_SIDED|95.0|-1.5|0.4|||constrained longitudinal analysis model|||Comparison: Change in Baseline in Percentage of Hypoglycemic Values \< 60 mg/dL. The comparison was conducted at the α=0.05 (2-sided) significance level.||0.4|-1.5|0.226
72407355|NCT02318693|144323101|SUPERIORITY_OR_OTHER||LS Means Difference|0.0||||0.332|TWO_SIDED|95.0|-0.1|0.0|||constrained longitudinal analysis model|||Comparison: Change in Baseline in Percentage of Hypoglycemic Values \< 50 mg/dL. The comparison was conducted at the α=0.05 (2-sided) significance level.||0.0|-0.1|0.332
72528220|NCT01265719|144587060|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.04|STANDARD_ERROR_OF_MEAN|0.3||0.902|TWO_SIDED|95.0|-0.63|0.56|||ANCOVA||Change from baseline to last available observation in HCD was analyzed using an ANCOVA model with fixed effect for treatment group with baseline HCD value as covariate.|\<5 years||0.56|-0.63|0.9020
72528221|NCT01265719|144587060|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.03|STANDARD_ERROR_OF_MEAN|0.2||0.8826|TWO_SIDED|95.0|-0.37|0.43|||ANCOVA||Change from baseline to last available observation in HCD was analyzed using an ANCOVA model with fixed effect for treatment group with baseline HCD value as covariate.|5 to \<18 years||0.43|-0.37|0.8826
72528222|NCT01265719|144587061|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-1.62|STANDARD_ERROR_OF_MEAN|1.25||0.2003|TWO_SIDED|95.0|-4.13|0.89|||ANCOVA||Change from baseline to last available observation in IOP was analyzed using an ANCOVA model with fixed effect for treatment group with baseline IOP value as covariate.|\<5 years||0.89|-4.13|0.2003
72625403|NCT01690273|144780218|SUPERIORITY_OR_OTHER|||||||0.07|||||||Mixed Models Analysis|||||||0.07
72528223|NCT01265719|144587061|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.75||0.894|TWO_SIDED|95.0|-1.59|1.39|||ANCOVA||Change from baseline to last available observation in IOP was analyzed using an ANCOVA model with fixed effect for treatment group with baseline IOP value as covariate.|5 to \<18 years (IOP \<21mmHg at Baseline)||1.39|-1.59|0.8940
72528224|NCT01265719|144587061|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-6.66|STANDARD_ERROR_OF_MEAN|2.41||0.0184|TWO_SIDED|95.0|-11.95|-1.36|||ANCOVA|The results were interpreted with caution because of the very small sample size of non-PG treatment group (n=4).|Change from baseline to last available observation in IOP was analyzed using an ANCOVA model with fixed effect for treatment group with baseline IOP value as covariate.|5 to \<18 years (IOP ≥21mmHg at Baseline)||-1.36|-11.95|0.0184
72528225|NCT01265719|144587062|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|1.0|||>|0.999|TWO_SIDED|95.0|-13.97|15.9|||Fisher Exact|||||15.90|-13.97|>0.999
72528226|NCT01265719|144587063|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|-0.4|||>|0.999|TWO_SIDED|95.0|-15.32|14.55|||Fisher Exact|||||14.55|-15.32|>0.999
72528227|NCT01265719|144587064|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|1.2|||>|0.999|TWO_SIDED|95.0|-13.78|16.09|||Fisher Exact|||||16.09|-13.78|>0.999
72528228|NCT01265719|144587066|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|1.6||||0.6414|TWO_SIDED|95.0|-13.39|16.48|||Fisher Exact|||||16.48|-13.39|0.6414
72625404|NCT01690273|144780218|SUPERIORITY_OR_OTHER|||||||0.13|||||||Mixed Models Analysis|||||||0.13
72528229|NCT01265719|144587067|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.61|STANDARD_ERROR_OF_MEAN|0.52||0.2437|TWO_SIDED|95.0|-0.43|1.65|||ANCOVA||Change from baseline to last available observation in longest lash length (LLL) was analyzed using an ANCOVA model with fixed effect for treatment group with baseline LLL value as covariate.|\<5 years||1.65|-0.43|0.2437
72528230|NCT01265719|144587067|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.21|STANDARD_ERROR_OF_MEAN|0.32||0.5199|TWO_SIDED|95.0|-0.85|0.43|||ANCOVA||Change from baseline to last available observation in LLL was analyzed using an ANCOVA model with fixed effect for treatment group with baseline LLL value as covariate.|5 to \<18 years||0.43|-0.85|0.5199
72528231|NCT01265719|144587068|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-2.68|STANDARD_ERROR_OF_MEAN|15.54||0.8643|TWO_SIDED|95.0|-34.3|28.94|||ANCOVA||Change from baseline to last available observation in corneal thickness was analyzed using an ANCOVA model with fixed effect for treatment group with baseline corneal thickness value as covariate.|\<5 years||28.94|-34.30|0.8643
72528232|NCT01265719|144587068|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.87|STANDARD_ERROR_OF_MEAN|4.87||0.8591|TWO_SIDED|95.0|-10.54|8.8|||ANCOVA||Change from baseline to last available observation in corneal thickness was analyzed using an ANCOVA model with fixed effect for treatment group with baseline corneal thickness value as covariate.|5 to \<18 years||8.80|-10.54|0.8591
72528233|NCT01265719|144587069|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|4.5||||0.2413|TWO_SIDED|95.0|-10.49|19.36|||Fisher Exact|||||19.36|-10.49|0.2413
72528234|NCT01722552|144587115|EQUIVALENCE|The margin for non-equivalence was 25 percentage points.|Risk Ratio (RR)|1.59|||<|0.05|TWO_SIDED|95.0|1.21|2.1|||Chi-squared|||The primary analysis was by intent to treat (ITT). This included data for all randomized subjects, with post-intervention adherence measured by the last 30 days of available data; adherence over the entire 6-month intervention period was measured using all available post-intervention data. Our sample size was designed to detect a 25 percentage point difference in proportion achieving optimal adherence post-intervention.||2.1|1.21|<0.05
72528235|NCT00732199|144587122|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||T- test was conducted to compare the 2 groups.||||<0.05
72528236|NCT00732199|144587123|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|Compares control vs hypoxia trials vs recovery post-hypoxia||||||<0.05
72528237|NCT00732199|144587124|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
72625405|NCT01690273|144780218|SUPERIORITY_OR_OTHER|||||||0.97|||||||Mixed Models Analysis|||||||0.97
72625406|NCT01690273|144780218|SUPERIORITY_OR_OTHER|||||||1|||||||Mixed Models Analysis|||||||1
72625407|NCT01690273|144780218|SUPERIORITY_OR_OTHER|||||||0.338|||||||Mixed Models Analysis|||||||0.338
72528238|NCT00732199|144587125|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
72528239|NCT00147082|144587144|SUPERIORITY|||||||0.05||||||The threshold for significance was p\<0.05|Kruskal-Wallis|||p values were calculated||||0.05
72528240|NCT00147082|144587145|SUPERIORITY|||||||0.05||||||The p value (\<0.05) was the threshold for significance|Kruskal-Wallis|||p value was calculated||||0.05
72528241|NCT00147082|144587146|SUPERIORITY|||||||0.05||||||The p value (\<0.05) was the threshold for significance|Kruskal-Wallis|||The p value was calculated||||0.05
72528242|NCT02996981|144587147|SUPERIORITY|||||||0.299|||||||Chi-squared|df=1||||||0.299
72528243|NCT00256204|144587183|SUPERIORITY_OR_OTHER|||||||0.0133|||||||Repeated Measures Mixed Linear Model|||"Hypothesis #1: Slopes Superiority of 1mg Rasagiline over Placebo in the PC Phase Where slope is the model estimate of the change from baseline in total UPDRS per week.~In this analysis, all available post-baseline observations in the PC Phase of the trial are analyzed (ITT efficacy data analysis set, weeks 12, 24 and 36). The placebo groups for rasagiline 1mg (delayed-start) and 2mg (delayed-start)are combined to one placebo group."||||0.0133
72528244|NCT00256204|144587183|SUPERIORITY_OR_OTHER|||||||0.0001||95.0|||||Repeated Measures Mixed Linear Model|||"Hypothesis #1: Slopes Superiority of 2mg Rasagiline over Placebo in the PC Phase Where slope is the model estimate of the change from baseline in total UPDRS per week.~In this analysis, all available post-baseline observations in the PC Phase of the trial are analyzed (ITT efficacy data analysis set, weeks 12, 24 and 36). The placebo groups for rasagiline 1mg (delayed-start)and 2mg (delayed-start) are combined to one placebo group."||||0.0001
72528245|NCT00256204|144587183|SUPERIORITY_OR_OTHER|||||||0.025||95.0||||The analysis was performed on separate datasets and not on the combined dataset as was pre-specified to account for unexpected interactions of dose level by baseline UPDRS and of dose level by center .|Repeated Measures|||Hypothesis #2: Superiority of Early over Delayed Start at Week 72 In this analysis, observations of subjects entering the active phase with at least 24 weeks of treatment during the PC Phase and at least one available Total UPDRS measurement during the active-treatment phase from weeks 48, 54, 60, 66 or 72, are analyzed (ACTE data analysis set).||||0.0250
72528246|NCT00256204|144587183|SUPERIORITY_OR_OTHER|||||||0.6028||95.0||||The analysis was performed on separate datasets and not on the combined dataset as was pre-specified to account for unexpected interactions of dose level by baseline UPDRS and of dose level by center|Repeated Measures|||Hypothesis #2:Superiority of Early over Delayed Start at Week 72 In this analysis, observations of subjects entering the active phase with at least 24 weeks of treatment during the PC Phase and at least one available Total UPDRS measurement during the active-treatment phase from weeks 48, 54, 60, 66 or 72, are analyzed (ACTE data analysis set.)||||0.6028
72625408|NCT01690273|144780218|SUPERIORITY_OR_OTHER|||||||0.476|||||||Mixed Models Analysis|||||||0.476
72625409|NCT01690273|144780219|SUPERIORITY_OR_OTHER|||||||0.88|||||||Mixed Models Analysis|||||||0.88
72625410|NCT01690273|144780219|SUPERIORITY_OR_OTHER|||||||0.99|||||||Mixed Models Analysis|||||||0.99
72625411|NCT01690273|144780219|SUPERIORITY_OR_OTHER|||||||1|||||||Mixed Models Analysis|||||||1
72625412|NCT01690273|144780219|SUPERIORITY_OR_OTHER|||||||1|||||||Mixed Models Analysis|||||||1
72625413|NCT01690273|144780219|SUPERIORITY_OR_OTHER|||||||0.995|||||||Mixed Models Analysis|||||||0.995
72625414|NCT01690273|144780219|SUPERIORITY_OR_OTHER|||||||0.985|||||||Mixed Models Analysis|||||||0.985
72625415|NCT01690273|144780220|SUPERIORITY_OR_OTHER|||||||0.9|||||||Mixed Models Analysis|||||||0.9
72625416|NCT01690273|144780220|SUPERIORITY_OR_OTHER|||||||0.7|||||||Mixed Models Analysis|||||||0.7
72625417|NCT01690273|144780220|SUPERIORITY_OR_OTHER|||||||0.99|||||||Mixed Models Analysis|||||||0.99
72625418|NCT01690273|144780220|SUPERIORITY_OR_OTHER|||||||0.999|||||||Mixed Models Analysis|||||||0.999
72625419|NCT01690273|144780220|SUPERIORITY_OR_OTHER|||||||0.9|||||||Mixed Models Analysis|||||||0.900
72407356|NCT00025883|144323102|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Mixed Models Analysis|||A null hypothesis of interest is there is no significant change over three time points (baseline, 6 months, 12 months) in response to metreleptin within GLD group.||||<0.001
72407357|NCT00025883|144323102|SUPERIORITY_OR_OTHER|||||||0.004|||||||Mixed Models Analysis|||A null hypothesis of interest is there is no significant change over three time points (baseline, 6 months, 12 months) in response to metreleptin within PLD group.||||0.004
72407358|NCT00025883|144323103|SUPERIORITY_OR_OTHER|||||||0.05|||||||Mixed Models Analysis|||Triglycerides were log transformed for analysis due to non-normal distribution. Changes in triglycedies in response to metreleptin over three time points (baseline, 6 months, 12 months) are tested within GLD group.||||0.05
72407359|NCT00025883|144323103|SUPERIORITY_OR_OTHER|||||||0.02|||||||Mixed Models Analysis|||Triglycerides were log transformed for analysis due to non-normal distribution. Changes in triglycedies in response to metreleptin over three time points (baseline, 6 months, 12 months) are tested within PLD group.||||0.02
72407360|NCT03080961|144323104|OTHER||SADE percentage|0.0|||||TWO_SIDED|95.0|0.0|7.7||||||SADE rate after minimally 26 days of VIBLOK treatment will be assessed by calculating the upper limit of the 2-sided exact 95% Clopper-Pearson confidence interval which needs to be below 10%. With a sample size of 36, an exact two-sided 95.0% confidence interval for a single proportion would show that the SADE incidence is below 10% at an expected incidence of 0.1%.||7.7|0.0|
72407361|NCT03080961|144323105|SUPERIORITY|||||||0.248|||||||Wilcoxon (Mann-Whitney)|||Statistical analysis will evaluate the difference in detection rate between pre and post-VIBLOK swabs. For each person the number of swabs with shedding only pre-VIBLOK will be assessed, and then the number of swabs with shedding only post-VIBLOK will be subtracted. A number above 0 indicates a decreased detection rate after VIBLOK. With an 8% anticipated asymptomatic shedding rate, 80% power, 50 subjects taking samples for 28 days are needed to show a 50% reduction.||||0.248
72571566|NCT03276221|144671792|SUPERIORITY||Slope|-11.64|STANDARD_ERROR_OF_MEAN|9.55||0.223|TWO_SIDED|||||The p-value was adjusted for multiple comparisons by the Bonferroni correction across outcomes for the rapid visual information processing module. The a priori threshold for statistical significance was 0.025.|Mixed Models Analysis|Estimates were obtained using generalized estimating equations (GEE) with robust standard errors obtained by the sandwich estimator.|The estimate is the mean difference in the median response latency for the abstinence group above and beyond the monitoring group (positive values indicate slower responses for the abstinence group).|The mean difference in scale scores between the abstinence and monitoring groups was estimated via a binomial model with a dummy-coded contrast (0 for monitoring, 1 for abstinence). The model adjusted for change at weeks 2, 3, and 4 of the study, and for a subject's scale scores at baseline.||||0.223
72407362|NCT03080961|144323106|SUPERIORITY|||||||0.013|||||||Wilcoxon (Mann-Whitney)|||||||0.013
72407363|NCT02026115|144323112|SUPERIORITY|||||||0.43|||||||Mixed Models Analysis|||||||.43
72407364|NCT02026115|144323113|SUPERIORITY|||||||0.02||||||Experimental group performed worse than usual care.|Mixed Models Analysis|||||||.02
72407365|NCT02026115|144323114|SUPERIORITY|||||||0.32|||||||Regression, Linear|||||||.32
72407366|NCT02026115|144323115|SUPERIORITY|||||||0.36|||||||Regression, Logistic|||||||.36
72407367|NCT02026115|144323116|SUPERIORITY|||||||0.01|||||||Regression, Linear|||||||.01
72407368|NCT02026115|144323117|SUPERIORITY||||||<|0.01|||||||Mixed Models Analysis|||||||<0.01
72407369|NCT04084769|144323150|OTHER|95% Confidence Interval (CI) of the difference in percentage was calculated from the Wilson Score method without continuity correction.|Difference in percentage|1.65|||||TWO_SIDED|95.0|-3.58|6.95||||||Serogroup A||6.95|-3.58|
72407370|NCT04084769|144323150|OTHER|95% CI of the difference in percentage was calculated from the Wilson Score Method without continuity correction.|Difference in percentage|-1.74|||||TWO_SIDED|95.0|-5.5|1.6||||||Serogroup C||1.60|-5.50|
72407371|NCT04084769|144323150|OTHER|95% CI of the difference in percentage was calculated from the Wilson Score Method without continuity correction.|Difference in percentage|-1.15|||||TWO_SIDED|95.0|-4.09|1.14||||||Serogroup Y||1.14|-4.09|
72407372|NCT04084769|144323150|OTHER|95% CI of the difference in percentage was calculated from the Wilson Score Method without continuity correction.|Difference in percentage|-1.16|||||TWO_SIDED|95.0|-4.72|2.07||||||Serogroup W||2.07|-4.72|
72407373|NCT03390504|144323160|SUPERIORITY||Hazard Ratio (HR)|0.65|||=|0.0031|TWO_SIDED|95.0|0.48|0.86|||Log Rank|||||0.86|0.48|=0.0031
72407374|NCT03390504|144323160|SUPERIORITY||Hazard Ratio (HR)|1.16|||=|0.2121|TWO_SIDED|95.0|0.92|1.48|||Stratified log-rank test|||||1.48|0.92|=0.2121
72625420|NCT01690273|144780220|SUPERIORITY_OR_OTHER|||||||0.739|||||||Mixed Models Analysis|||||||0.739
72407375|NCT02665481|144323227|SUPERIORITY||Mean Difference (Final Values)|-0.04||||0.5|TWO_SIDED|95.0|-0.15|0.07|||Marginal Model|||Time x MBSR (Month 0 and Month 6)||0.07|-0.15|0.50
72407376|NCT02665481|144323227|SUPERIORITY||Mean Difference (Final Values)|0.08||||0.18|TWO_SIDED|95.0|-0.04|0.19|||Marginal Model|||Time x MBSR (Month 0 and Month 18)||0.19|-0.04|0.18
72407377|NCT02665481|144323227|SUPERIORITY||Mean Difference (Final Values)|0.07||||0.23|TWO_SIDED|95.0|-0.04|0.17|||Marginal Model|||Time x Exercise (Month 0 and Month 6)||0.17|-0.04|0.23
72407378|NCT02665481|144323227|SUPERIORITY||Mean Difference (Final Values)|-0.04||||0.47|TWO_SIDED|95.0|-0.15|0.07|||Marginal Model|||Time x Exercise (Month 0 and Month 18)||0.07|-0.15|0.47
72407379|NCT02665481|144323228|SUPERIORITY||Mean Difference (Final Values)|0.08||||0.12|TWO_SIDED|95.0|-0.02|0.19|||Marginal Model|||Time x MBSR (Month 0 and Month 6)||0.19|-0.02|0.12
72407380|NCT02665481|144323228|SUPERIORITY||Mean Difference (Final Values)|-0.04||||0.44|TWO_SIDED|95.0|-0.15|0.07|||Marginal Model|||Time x MBSR (Month 0 and Month 18)||0.07|-0.15|0.44
72407381|NCT02665481|144323228|SUPERIORITY||Mean Difference (Final Values)|0.07||||0.17|TWO_SIDED|95.0|-0.03|0.18|||Marginal Model|||Time x Exercise (Month 0 and Month 6)||0.18|-0.03|0.17
72407382|NCT02665481|144323228|SUPERIORITY||Mean Difference (Final Values)|-0.01||||0.93|TWO_SIDED|95.0|-0.12|0.11|||Marginal Model|||Time x Exercise (Month 0 and Month 18).||0.11|-0.12|0.93
72407383|NCT02665481|144323229|SUPERIORITY||Mean Difference (Final Values)|-3.46||||0.53|TWO_SIDED|95.0|-14.27|7.34|||Marginal Model|||Time x MBSR (Month 0 and Month 6)||7.34|-14.27|0.53
72407384|NCT02665481|144323229|SUPERIORITY||Mean Difference (Final Values)|-20.16||||0.004|TWO_SIDED|95.0|-33.88|-6.44|||Marginal Model|||Time x MBSR (Month 0 and Month 18).||-6.44|-33.88|0.004
72407385|NCT02665481|144323229|SUPERIORITY||Mean Difference (Final Values)|3.04||||0.58|TWO_SIDED|95.0|-7.76|13.85|||Marginal Model|||Time x Exercise (Month 0 and Month 6)||13.85|-7.76|0.58
72407386|NCT02665481|144323229|SUPERIORITY||Mean Difference (Final Values)|-6.26||||0.37|TWO_SIDED|95.0|-19.98|7.46|||Marginal Model|||Time x Exercise (Month 0 and Month 18).||7.46|-19.98|0.37
72407387|NCT02665481|144323230|SUPERIORITY||Mean Difference (Final Values)|22.71||||0.33|TWO_SIDED|95.0|-22.95|68.36|||Marginal Model|||Time x MBSR (Month 0 and Month 6)||68.36|-22.95|0.33
72407388|NCT02665481|144323230|SUPERIORITY||Mean Difference (Final Values)|25.35||||0.31|TWO_SIDED|95.0|-23.18|73.88|||Marginal Model|||Time x MBSR (Month 0 and Month 18)||73.88|-23.18|0.31
72528247|NCT00256204|144587183|NON_INFERIORITY_OR_EQUIVALENCE|Non-Inf Test for difference in slopes between treatment groups. One sided 95% CI calculated for difference between slopes of the 1mg early-start group and the 1mg delayed-start group. The inferiority null hypothesis of the early-start group slope over delayed-start group slope is rejected, if the upper limit of one sided 95% CI for difference in slopes does not cross non-inferiority margin of 0.15 UPDRS points per week.|Slope|0.0||||||90.0|-0.036|0.036||||||"Hypothesis #3: Slopes Non-Inferiority of Early Start over Delayed Start in the Active Phase.~Where slope is the model estimate of the change from baseline in total UPDRS per week. In this analysis, observations of all subjects entering the active phase with at least 24 weeks of treatment during the PC Phase and at least one available Total UPDRS measurement during the active treatment phase from weeks 48, 54, 60, 66 or 72, are analyzed (ACTE data analysis set)."||0.036|-0.036|
72528248|NCT00256204|144587183|NON_INFERIORITY_OR_EQUIVALENCE|Non-Inf Test for difference in slopes between treatment groups. One sided 95% CI calculated for difference between slopes of the 2mg early-start group and the 2mg delayed-start group. The inferiority null hypothesis of the early-start group slope over delayed-start group slope is rejected, if the upper limit of one sided 95% CI for difference in slopes does not cross non-inferiority margin of 0.15 UPDRS points per week.|Slope|0.029||||||90.0|-0.005|0.062||||||"Hypothesis #3: Slopes Non-Inferiority of Early Start over Delayed Start in the Active Phase.~Where slope is the model estimate of the change from baseline in total UPDRS per week. In this analysis, observations of all subjects entering the active phase with at least 24 weeks of treatment during the PC Phase and at least one available Total UPDRS measurement during the active treatment phase from weeks 48, 54, 60, 66 or 72, are analyzed (ACTE data analysis set)."||0.062|-0.005|
72542596|NCT00361257|144615071|SUPERIORITY_OR_OTHER||Slope|-0.405|STANDARD_ERROR_OF_MEAN|0.391||0.304|TWO_SIDED|95.0|-1.182|0.373||The p-value was not adjusted for multiple comparisons.|Regression, Linear|The model was adjusted for the stratification variables, the baseline CNS penetration score, and the baseline medication management score.||The null hypothesis was that the 24 change of medication management test score in the minocycline group was the same as the one in the placebo group.||0.373|-1.182|0.304
72542597|NCT00361257|144615076|SUPERIORITY_OR_OTHER||Slope|-0.097|STANDARD_ERROR_OF_MEAN|0.146||0.506|TWO_SIDED|95.0|-0.388|0.193||The p-value was not adjusted for multiple comparisons.|Regression, Linear|The model was adjusted for the stratification variables, the baseline CNS penetration score, and the baseline alternate psychomotor function score.||The null hypothesis was that the 24 week change in alternate psychomotor function score in the minocycline group was the same as the one in the placebo group.||0.193|-0.388|0.506
72542598|NCT00361257|144615077|SUPERIORITY_OR_OTHER||Slope|0.146|STANDARD_ERROR_OF_MEAN|0.207||0.484|TWO_SIDED|95.0|-0.266|0.558||The p-value was not adjusted for multiple comparisons.|Regression, Linear|The model was adjusted for stratification variables, baseline CNS penetration score, and the baseline alternate verbal memory score.||The null hypothesis was that the 24 week change in the alternate verbal memory score in the minocycline group was the same as the one in the placebo group.||0.558|-0.266|0.484
72625421|NCT01690273|144780221|SUPERIORITY_OR_OTHER|||||||1|||||||Mixed Models Analysis|||||||1
72625422|NCT01690273|144780221|SUPERIORITY_OR_OTHER|||||||1|||||||Mixed Models Analysis|||||||1
72625423|NCT01690273|144780221|SUPERIORITY_OR_OTHER|||||||0.37|||||||Mixed Models Analysis|||||||0.37
72407389|NCT02665481|144323230|SUPERIORITY||Mean Difference (Final Values)|-17.18||||0.46|TWO_SIDED|95.0|-62.83|28.48|||Marginal Model|||Time x Exercise (Month 0 and Month 6).||28.48|-62.83|0.46
72407390|NCT02665481|144323230|SUPERIORITY||Mean Difference (Final Values)|21.11||||0.39|TWO_SIDED|95.0|-27.41|69.64|||Marginal Model|||Time x Exercise (Month 0 and Month 18).||69.64|-27.41|0.39
72407391|NCT02665481|144323231|SUPERIORITY||Mean Difference (Final Values)|-0.01||||0.37|TWO_SIDED|95.0|-0.02|0.01|||Marginal Model|||Time x MBSR (Month 0 and Month 6).||0.01|-0.02|0.37
72407392|NCT02665481|144323231|SUPERIORITY||Mean Difference (Final Values)|-0.01||||0.1|TWO_SIDED|95.0|-0.02|0.0|||Marginal Model|||Time x MBSR (Month 0 and Month 18).||0.00|-0.02|0.10
72407393|NCT02665481|144323231|SUPERIORITY||Mean Difference (Final Values)|0.01||||0.21|TWO_SIDED|95.0|-0.004|0.02|||Marginal Model|||Time x Exercise (Month 0 and Month 6).||0.02|-0.004|0.21
72407394|NCT02665481|144323231|SUPERIORITY||Mean Difference (Final Values)|-0.01||||0.09|TWO_SIDED|95.0|-0.02|0.0|||Marginal Model|||Time x Exercise (Month 0 and Month 18).||0.00|-0.02|0.09
72407395|NCT02665481|144323232|SUPERIORITY||Mean Difference (Final Values)|0.16||||0.57|TWO_SIDED|95.0|-0.38|0.69|||Marginal Model|||Time x MBSR (Month 0 and Month 6)||0.69|-0.38|0.57
72542599|NCT00361257|144615078|SUPERIORITY_OR_OTHER||Slope|0.055|STANDARD_ERROR_OF_MEAN|0.137||0.69|TWO_SIDED|95.0|-0.217|0.327||The p-value was not adjusted for multiple comparisons.|Regression, Linear|The model was adjusted for stratification variables, baseline CNS penetration score, and the baseline alternate frontal systems score.||The null hypothesis was the 24 week change of alternate frontal systems score in the minocycline group was the same as the one in the placebo group.||0.327|-0.217|0.690
72542600|NCT00660790|144615082|OTHER|||||||0.021|||||||Wilcoxon (Mann-Whitney)|||The paired student's t-test or the Wilcoxon signed-rank test was used to compare the measurements before and after multifactorial treatment, as appropriate, depending on the distribution of the data.||||0.021
72625424|NCT01690273|144780221|SUPERIORITY_OR_OTHER|||||||0.618|||||||Mixed Models Analysis|||||||0.618
72625425|NCT01690273|144780221|SUPERIORITY_OR_OTHER|||||||1|||||||Mixed Models Analysis|||||||1
72625426|NCT01690273|144780221|SUPERIORITY_OR_OTHER|||||||0.689|||||||Mixed Models Analysis|||||||0.689
72407396|NCT02665481|144323232|SUPERIORITY||Mean Difference (Final Values)|-0.01||||0.96|TWO_SIDED|95.0|-0.58|0.55|||Marginal Model|||Time x MBSR (Month 0 and Month 18).||0.55|-0.58|0.96
72407397|NCT02665481|144323232|SUPERIORITY||Mean Difference (Final Values)|-0.24||||0.37|TWO_SIDED|95.0|-0.78|0.29|||Marginal Model|||Time x Exercise (Month 0 and Month 6).||0.29|-0.78|0.37
72407398|NCT02665481|144323232|SUPERIORITY||Mean Difference (Final Values)|-0.003||||0.99|TWO_SIDED|95.0|-0.57|0.57|||Marginal Model|||Time x Exercise (Month 0 and Month 18).||0.57|-0.57|0.99
72407399|NCT02665481|144323233|SUPERIORITY||Mean Difference (Final Values)|0.93||||0.19|TWO_SIDED|95.0|-0.47|2.33|||Marginal Model|||Time x MBSR (Month 0 and Month 6).||2.33|-0.47|0.19
72571567|NCT02912650|144671798|SUPERIORITY_OR_OTHER||Least Squares (LS) Mean Difference|30.08|||<|0.001|TWO_SIDED|95.0|24.14|36.02|||ANCOVA|||Treatment difference and 95 percent (%) confidence interval (CI) were based on LS Mean from analysis of covariance (ANCOVA) with treatment, gender, baseline categorical pain severity rating (PSR) as classification variables and baseline numerical PSR used as a continuous covariate.||36.02|24.14|<0.001
72571568|NCT02912650|144671798|SUPERIORITY_OR_OTHER||LS Mean Difference|5.66||||0.008|TWO_SIDED|95.0|1.51|9.8|||ANCOVA|||Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||9.80|1.51|0.008
72571569|NCT02912650|144671798|SUPERIORITY_OR_OTHER||LS Mean Difference|14.76|||<|0.001|TWO_SIDED|95.0|10.55|18.97|||ANCOVA|||Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||18.97|10.55|<0.001
72571570|NCT02912650|144671798|SUPERIORITY_OR_OTHER||LS Mean Difference|24.42|||<|0.001|TWO_SIDED|95.0|18.5|30.35|||ANCOVA|||Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||30.35|18.50|<0.001
72571571|NCT02912650|144671798|SUPERIORITY_OR_OTHER||LS Mean Difference|15.32|||<|0.001|TWO_SIDED|95.0|9.35|21.29|||ANCOVA|||Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||21.29|9.35|<0.001
72571572|NCT02912650|144671798|SUPERIORITY_OR_OTHER||LS Mean Difference|9.1|||<|0.001|TWO_SIDED|95.0|4.9|13.31|||ANCOVA|||Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||13.31|4.90|<0.001
72625427|NCT01690273|144780222|SUPERIORITY_OR_OTHER|||||||0.8|||||||Mixed Models Analysis|||||||0.8
72625428|NCT01690273|144780222|SUPERIORITY_OR_OTHER|||||||0.97|||||||Mixed Models Analysis|||||||0.97
72407400|NCT02665481|144323233|SUPERIORITY||Mean Difference (Final Values)|1.29||||0.09|TWO_SIDED|95.0|-0.19|2.77|||Marginal Model|||Time x MBSR (Month 0 and Month 18).||2.77|-0.19|0.09
72407401|NCT02665481|144323233|SUPERIORITY||Mean Difference (Final Values)|-0.57||||0.42|TWO_SIDED|95.0|-1.97|0.83|||Marginal Model|||Time x Exercise (Month 0 and Month 6).||0.83|-1.97|0.42
72571573|NCT02912650|144671799|SUPERIORITY_OR_OTHER||LS Mean Difference|9.26|||<|0.001|TWO_SIDED|95.0|6.59|11.94|||ANCOVA|||Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||11.94|6.59|<0.001
72571574|NCT02912650|144671799|SUPERIORITY_OR_OTHER||LS Mean Difference|1.84||||0.053|TWO_SIDED|95.0|-0.03|3.71|||ANCOVA|||Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||3.71|-0.03|0.053
72571575|NCT02912650|144671799|SUPERIORITY_OR_OTHER||LS Mean Difference|5.59|||<|0.001|TWO_SIDED|95.0|3.69|7.49|||ANCOVA|||Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||7.49|3.69|<0.001
72571576|NCT02912650|144671799|SUPERIORITY_OR_OTHER||LS Mean Difference|7.42|||<|0.001|TWO_SIDED|95.0|4.75|10.09|||ANCOVA|||Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||10.09|4.75|<0.001
72571577|NCT02912650|144671799|SUPERIORITY_OR_OTHER||LS Mean Difference|3.67||||0.008|TWO_SIDED|95.0|0.98|6.36|||ANCOVA|||Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||6.36|0.98|0.008
72407402|NCT02665481|144323233|SUPERIORITY||Mean Difference (Final Values)|0.47||||0.54|TWO_SIDED|95.0|-1.01|1.94|||Marginal Model|||Time x Exercise (Month 0 and Month 18).||1.94|-1.01|0.54
72571578|NCT02912650|144671799|SUPERIORITY_OR_OTHER||LS Mean Difference|3.75|||<|0.001|TWO_SIDED|95.0|1.85|5.64|||ANCOVA|||Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||5.64|1.85|<0.001
72571579|NCT02912650|144671800|SUPERIORITY_OR_OTHER||LS Mean Difference|13.05|||<|0.001|TWO_SIDED|95.0|10.39|15.71|||ANOVA|||0-8 hours: Treatment difference and 95% CI were based on LS Mean from analysis of variance (ANOVA) with treatment, gender and baseline categorical PSR.||15.71|10.39|<0.001
72571580|NCT02912650|144671800|SUPERIORITY_OR_OTHER||LS Mean Difference|3.01||||0.002|TWO_SIDED|95.0|1.15|4.86|||ANOVA|||0 to 8 hours: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||4.86|1.15|0.002
72571581|NCT02912650|144671800|SUPERIORITY_OR_OTHER||LS Mean Difference|6.94|||<|0.001|TWO_SIDED|95.0|5.06|8.83|||ANOVA|||0 to 8 hours: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||8.83|5.06|<0.001
72571582|NCT02912650|144671800|SUPERIORITY_OR_OTHER||LS Mean Difference|10.05|||<|0.001|TWO_SIDED|95.0|7.39|12.7|||ANOVA|||0 to 8 hours: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||12.70|7.39|<0.001
72571583|NCT02912650|144671800|SUPERIORITY_OR_OTHER||LS Mean Difference|6.11|||<|0.001|TWO_SIDED|95.0|3.44|8.78|||ANOVA|||0 to 8 hours: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||8.78|3.44|<0.001
72625429|NCT01690273|144780222|SUPERIORITY_OR_OTHER|||||||0.99|||||||Mixed Models Analysis|||||||0.99
72625430|NCT01690273|144780222|SUPERIORITY_OR_OTHER|||||||0.999|||||||Mixed Models Analysis|||||||0.999
72625431|NCT01690273|144780222|SUPERIORITY_OR_OTHER|||||||0.929|||||||Mixed Models Analysis|||||||0.929
72625432|NCT01690273|144780222|SUPERIORITY_OR_OTHER|||||||0.98|||||||Mixed Models Analysis|||||||0.980
72625433|NCT01690273|144780223|SUPERIORITY_OR_OTHER|||||||1|||||||Mixed Models Analysis|||||||1
72625434|NCT01690273|144780223|SUPERIORITY_OR_OTHER|||||||0|||||||Mixed Models Analysis|||||||0.000
72407403|NCT02896127|144323293|SUPERIORITY||Odds Ratio (OR)|2.47|||<|0.0001|TWO_SIDED|95.0|1.65|3.69|||Regression, Logistic||||"PTFU=post-treatment follow-up (12 weeks after last study treatment)~95% confidence intervals are from a score method with continuity correction."|3.69|1.65|<.0001
72407404|NCT03354429|144323307|SUPERIORITY||Hazard Ratio (HR)|0.83||||0.015|TWO_SIDED|95.0|0.71|0.96||The hypothesis was tested at the 4.996% two-sided significance level to account for the planned interim analysis with the overall type I error preserved at 5%. A hierarchical test sequence was used to address the issue of multiple testing|Regression, Cox||Placebo is the reference group (denominator)|||0.96|0.71|0.015
72528249|NCT00256204|144587184|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.005|||<|0.0001||95.0|-3.857|-2.153|||ANCOVA|||The adjusted means of the changes in Total UPDRS from baseline to LOV in the placebo-controlled phase, observed in the 1 mg and 2 mg rasagiline early-start groups are compared (two contrasts) to the combined placebo group (1 mg and 2 mg rasagiline delayed-start groups), by applying an Analysis of Covariance model. The model includes treatment group, center and baseline Total UPDRS as covariates. For this analysis, both delayed start arms are pooled as a 'placebo arm'||-2.153|-3.857|<0.0001
72528250|NCT00256204|144587184|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.154|||<|0.0001||95.0|-4.004|-2.305|||ANCOVA|||"The adjusted means of the changes in Total UPDRS from baseline to LOV in the placebo-controlled phase, observed in the 1 mg and 2 mg rasagiline early-start groups are compared (two contrasts) to the combined placebo group (1 mg and 2 mg rasagiline delayed-start groups), by applying an Analysis of Covariance model. The model includes treatment group, center and baseline Total UPDRS as covariates.~For this analysis, both delayed start arms are pooled as a 'placebo arm'"||-2.305|-4.004|<0.0001
72528251|NCT03427528|144587185|OTHER|To assess paternal and maternal outcomes on the BDI-II we conducted a series of paired t-tests with Bonferroni correction for multiple comparisons. T-tests compared baseline scores on each outcome to 3-month follow-up scores, with separate t-tests conducted to examine changes between baseline and 6-month follow-up. We used a Cohen's d statistic to indicate effect sizes for our BDI-II.|||||<|0.05|||||||Paired T-test|||We used a single group longitudinal pre-post design to evaluate study outcomes||||<0.05
72528252|NCT03427528|144587186|OTHER|To assess paternal and maternal outcomes on the GAD-7, we conducted a series of paired t-tests with Bonferroni correction for multiple comparisons. T-tests compared baseline scores on each outcome to 3-month follow-up scores, with separate t-tests conducted to examine changes between baseline and 6-month follow-up. We used a Cohen's d statistic to indicate effect sizes for our outcomes.|||||>|0.05|||||||Paired T-test|||We used a single group longitudinal pre-post design to evaluate study outcomes||||>0.05
72528253|NCT03427528|144587187|OTHER|To assess paternal and maternal outcomes on the PSS-10, we conducted a series of paired t-tests with Bonferroni correction for multiple comparisons. T-tests compared baseline scores on each outcome to 3-month follow-up scores, with separate t-tests conducted to examine changes between baseline and 6-month follow-up. We used a Cohen's d statistic to indicate effect sizes for our PSS-10 outcomes.|||||<|0.05|||||||Paired T-test|||We used a single group longitudinal pre-post design to evaluate study outcomes||||<0.05
72528254|NCT03427528|144587187|OTHER|To assess paternal and maternal outcomes on the PSS-10 we conducted a series of paired t-tests with Bonferroni correction for multiple comparisons. T-tests compared baseline scores on each outcome to 3-month follow-up scores, with separate t-tests conducted to examine changes between baseline and 6-month follow-up. We used a Cohen's d statistic to indicate effect sizes for our PSS-10 outcomes.|||||<|0.05|||||||Paired T-test|||We used a single group longitudinal pre-post design to evaluate study outcomes||||<0.05
72528255|NCT03427528|144587188|OTHER||||||>|0.05|||||||t-test, 2 sided|||We used a single group longitudinal pre-post design to evaluate study outcomes||||>0.05
72528256|NCT00808132|144587192|SUPERIORITY_OR_OTHER||Least Squares (LS) Mean Difference|1.51|||<|0.001|TWO_SIDED|95.0|0.822|2.201|||ANCOVA|||Analysis of covariance (ANCOVA) model was used with treatment and region as main effects and baseline BMD and years since menopause as covariates.||2.201|0.822|<0.001
72528257|NCT00808132|144587192|SUPERIORITY_OR_OTHER||LS Mean Difference|1.87|||<|0.001|TWO_SIDED|95.0|1.209|2.533|||ANCOVA|||ANCOVA model was used with treatment and region as main effects and baseline BMD and years since menopause as covariates.||2.533|1.209|<0.001
72528258|NCT00808132|144587193|SUPERIORITY_OR_OTHER||LS Mean Difference|0.8||||0.017|TWO_SIDED|95.0|0.139|1.47|||ANCOVA|||ANCOVA model was used with treatment and region as main effects and baseline BMD and years since menopause as covariates.||1.470|0.139|0.017
72528259|NCT00808132|144587193|SUPERIORITY_OR_OTHER||LS Mean Difference|1.19|||<|0.001|TWO_SIDED|95.0|0.556|1.83|||ANCOVA|||ANCOVA model was used with treatment and region as main effects and baseline BMD and years since menopause as covariates.||1.830|0.556|<0.001
72407405|NCT03354429|144323308|SUPERIORITY||Hazard Ratio (HR)|0.79||||0.004|TWO_SIDED|95.0|0.68|0.93||The hypothesis was tested at the 4.996% two-sided significance level to account for the planned interim analysis with the overall type I error preserved at 5%. A hierarchical test sequence was used to address the issue of multiple testing|Regression, Cox||Placebo is the reference group (denominator)|||0.93|0.68|0.004
72528260|NCT00808132|144587194|SUPERIORITY_OR_OTHER||LS Mean Difference|1.32|||<|0.001|TWO_SIDED|95.0|0.901|1.742|||ANCOVA|||Month 6: ANCOVA model was used with treatment and region as main effects and baseline BMD and years since menopause as covariates.||1.742|0.901|<0.001
72528261|NCT00808132|144587194|SUPERIORITY_OR_OTHER||LS Mean Difference|1.21|||<|0.001|TWO_SIDED|95.0|0.756|1.671|||ANCOVA|||Month 12: ANCOVA model was used with treatment and region as main effects and baseline BMD and years since menopause as covariates.||1.671|0.756|<0.001
72528262|NCT00808132|144587194|SUPERIORITY_OR_OTHER||LS Mean Difference|1.56|||<|0.001|TWO_SIDED|95.0|1.152|1.962|||ANCOVA|||Month 6: ANCOVA model was used with treatment and region as main effects and baseline BMD and years since menopause as covariates.||1.962|1.152|<0.001
72528263|NCT00808132|144587194|SUPERIORITY_OR_OTHER||LS Mean Difference|1.6|||<|0.001|TWO_SIDED|95.0|1.164|2.044|||ANCOVA|||Month 12: ANCOVA model was used with treatment and region as main effects and baseline BMD and years since menopause as covariates.||2.044|1.164|<0.001
72528264|NCT00808132|144587195|SUPERIORITY_OR_OTHER|||||||0.138|TWO_SIDED||||||Fisher Exact|||||||0.138
72528265|NCT00808132|144587195|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Fisher Exact|||||||< 0.001
72528266|NCT00808132|144587195|SUPERIORITY_OR_OTHER|||||||0.765|TWO_SIDED||||||Fisher Exact|||||||0.765
72528267|NCT00808132|144587195|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Fisher Exact|||||||< 0.001
72528268|NCT00808132|144587195|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Fisher Exact|||||||< 0.001
72407406|NCT03354429|144323309|SUPERIORITY||Odds Ratio (OR)|0.98||||0.613|TWO_SIDED|95.0|0.89|1.07||The hypothesis was tested at the 4.996% two-sided significance level to account for the planned interim analysis with the overall type I error preserved at 5%. A hierarchical test sequence was used to address the issue of multiple testing|Regression, Logistic|NIHSS (National Institutes of Health Stroke Scale) score and history of stroke (yes/no) included as covariates|Placebo is the reference group (denominator)|||1.07|0.89|0.613
72571584|NCT02912650|144671800|SUPERIORITY_OR_OTHER||LS Mean Difference|3.94|||<|0.001|TWO_SIDED|95.0|2.06|5.81|||ANOVA|||0 to 8 hours: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||5.81|2.06|<0.001
72571585|NCT02912650|144671800|SUPERIORITY_OR_OTHER||LS Mean Difference|3.84|||<|0.001|TWO_SIDED|95.0|2.63|5.05|||ANOVA|||6 to 8 hours: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||5.05|2.63|<0.001
72571586|NCT02912650|144671800|SUPERIORITY_OR_OTHER||LS Mean Difference|1.07||||0.013|TWO_SIDED|95.0|0.23|1.92|||ANOVA|||6 to 8 hours: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.92|0.23|0.013
72571587|NCT02912650|144671800|SUPERIORITY_OR_OTHER||LS Mean Difference|2.69|||<|0.001|TWO_SIDED|95.0|1.83|3.55|||ANOVA|||6 to 8 hours: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||3.55|1.83|<0.001
72625435|NCT01690273|144780223|SUPERIORITY_OR_OTHER|||||||0.35|||||||Mixed Models Analysis|||||||0.350
72625436|NCT01690273|144780223|SUPERIORITY_OR_OTHER|||||||0.997|||||||Mixed Models Analysis|||||||0.997
72528269|NCT00808132|144587196|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.06||||0.832|TWO_SIDED|95.0|-0.632|0.509|||ANCOVA|||ANCOVA model was used with treatment and region as factors and baseline as a covariate.||0.509|-0.632|0.832
72528270|NCT00808132|144587196|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.13||||0.651|TWO_SIDED|95.0|-0.696|0.436|||ANCOVA|||ANCOVA model was used with treatment and region as factors and baseline as a covariate.||0.436|-0.696|0.651
72528271|NCT00808132|144587197|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Osteocalcin: Month 6, ANCOVA model was used with treatment and region as factors, and baseline as covariate.||||<0.001
72528272|NCT00808132|144587197|SUPERIORITY_OR_OTHER|||||||0.0074|TWO_SIDED||||||ANCOVA|||Osteocalcin: Month 6, ANCOVA model was used with treatment and region as factors, and baseline as covariate.||||0.0074
72528273|NCT00808132|144587197|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Osteocalcin: Month 12, ANCOVA model was used with treatment and region as factors, and baseline as covariate.||||<0.001
72528274|NCT00808132|144587197|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Osteocalcin: Month 12, ANCOVA model was used with treatment and region as factors, and baseline as covariate.||||<0.001
72571588|NCT02912650|144671800|SUPERIORITY_OR_OTHER||LS Mean Difference|2.77|||<|0.001|TWO_SIDED|95.0|1.56|3.98|||ANOVA|||6 to 8 hours: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||3.98|1.56|<0.001
72571589|NCT02912650|144671800|SUPERIORITY_OR_OTHER||LS Mean Difference|1.15||||0.064|TWO_SIDED|95.0|-0.07|2.37|||ANOVA|||6 to 8 hours: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||2.37|-0.07|0.064
72571590|NCT02912650|144671800|SUPERIORITY_OR_OTHER||LS Mean Difference|1.62|||<|0.001|TWO_SIDED|95.0|0.76|2.47|||ANOVA|||6 to 8 hours: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||2.47|0.76|<0.001
72571591|NCT02912650|144671801|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Gehan-Wilcoxon test|||p-value was calculated by using Gehan-Wilcoxon test, stratified by gender and baseline categorical PSR terms.||||<0.001
72571592|NCT02912650|144671801|SUPERIORITY_OR_OTHER|||||||0.069|||||||Gehan-Wilcoxon test|||p-value was calculated by using Gehan-Wilcoxon test, stratified by gender and baseline categorical PSR terms.||||0.069
72571593|NCT02912650|144671801|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Gehan-Wilcoxon test|||p-value was calculated by using Gehan-Wilcoxon test, stratified by gender and baseline categorical PSR terms.||||<0.001
72571594|NCT02912650|144671801|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Gehan-Wilcoxon test|||p-value was calculated by using Gehan-Wilcoxon test, stratified by gender and baseline categorical PSR terms.||||<0.001
72571595|NCT02912650|144671801|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Gehan-Wilcoxon test|||p-value was calculated by using Gehan-Wilcoxon test, stratified by gender and baseline categorical PSR terms.||||<0.001
72571596|NCT02912650|144671801|SUPERIORITY_OR_OTHER|||||||0.005|||||||Gehan-Wilcoxon test|||p-value was calculated by using Gehan-Wilcoxon test, stratified by gender and baseline categorical PSR terms.||||0.005
72571597|NCT02912650|144671802|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-45.27|||<|0.001|TWO_SIDED|95.0|-58.96|-31.58|||Cochran-Mantel-Haenszel|||At 8 hour: Treatment difference and its associated 95% CI were calculated based on Cochran-Mantel-Haenszel (CMH) adjusted proportions, controlling for baseline categorical PSR and gender using table scores.||-31.58|-58.96|<0.001
72571598|NCT02912650|144671802|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-8.88||||0.064|TWO_SIDED|95.0|-18.27|0.5|||Cochran-Mantel-Haenszel|||At 8 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions, controlling for baseline categorical PSR and gender using table scores.||0.50|-18.27|0.064
72571599|NCT02912650|144671802|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-26.98|||<|0.001|TWO_SIDED|95.0|-36.91|-17.05|||ANOVA|||At 8 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions, controlling for baseline categorical PSR and gender using table scores.||-17.05|-36.91|<0.001
72571600|NCT02912650|144671802|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-36.26|||<|0.001|TWO_SIDED|95.0|-50.45|-22.07|||Cochran-Mantel-Haenszel|||At 8 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions, controlling for baseline categorical PSR and gender using table scores.||-22.07|-50.45|<0.001
72625437|NCT01690273|144780223|SUPERIORITY_OR_OTHER|||||||0.97|||||||Mixed Models Analysis|||||||0.970
72625438|NCT01690273|144780223|SUPERIORITY_OR_OTHER|||||||0.999|||||||Mixed Models Analysis|||||||0.999
72625439|NCT01690273|144780224|SUPERIORITY_OR_OTHER|||||||0.997|||||||Mixed Models Analysis|||||||0.997
72625440|NCT01690273|144780224|SUPERIORITY_OR_OTHER|||||||0|||||||Mixed Models Analysis|||||||0.000
72625441|NCT01690273|144780224|SUPERIORITY_OR_OTHER|||||||0.503|||||||Mixed Models Analysis|||||||0.503
72625442|NCT01690273|144780224|SUPERIORITY_OR_OTHER|||||||0.814|||||||Mixed Models Analysis|||||||0.814
72407407|NCT03354429|144323310|OTHER||Hazard Ratio (HR)|3.99||||0.001|TWO_SIDED|95.0|1.74|9.14|||Regression, Cox||Placebo is the reference group (denominator)|||9.14|1.74|0.001
72407408|NCT03354429|144323311|OTHER||Hazard Ratio (HR)|3.66||||0.005|TWO_SIDED|95.0|1.48|9.02|||Regression, Cox||Placebo is the reference group (denominator)|||9.02|1.48|0.005
72407409|NCT03354429|144323312|OTHER||Hazard Ratio (HR)|3.27|||<|0.001|TWO_SIDED|95.0|1.67|6.43|||Regression, Cox||Placebo is the reference group (denominator)|||6.43|1.67|<0.001
72407410|NCT03354429|144323313|OTHER||Hazard Ratio (HR)|4.8|||<|0.001|TWO_SIDED|95.0|3.28|7.02|||Regression, Cox||Placebo is the reference group (denominator)|||7.02|3.28|<0.001
72407411|NCT02566759|144323374|SUPERIORITY_OR_OTHER_LEGACY||Slope|0.6662|||||TWO_SIDED|90.0|0.5969|0.7355||||||Dose proportionality was evaluated using the following power model: ln (PK Parameter) is equal to (=) a+b\*ln (dose), where a and b are the intercept and slope of the line, respectively. Dose proportionality was declared when the 90 percent (%) confidence interval (CI) of the slope lies entirely within the critical region (0.9483, 1.0517) for the dose range of 10 mg to 750 mg.||0.7355|0.5969|
72407412|NCT02566759|144323374|SUPERIORITY_OR_OTHER_LEGACY||Slope|0.7795|||||TWO_SIDED|90.0|0.6597|0.8993|||Power model|||Dose proportionality was evaluated using the following power model: ln (PK Parameter) = a+b\*ln (dose), where a and b were the intercept and slope of the line, respectively. Dose proportionality was declared when the 90% CI of the slope lies entirely within the critical region (0.9139, 1.0861) for the dose range of 30 mg to 400 mg.||0.8993|0.6597|
72407413|NCT02566759|144323374|SUPERIORITY_OR_OTHER_LEGACY||Least Square (LS) Mean Ratio|0.362|||||TWO_SIDED|90.0|0.3043|0.4301||||||The point estimate and CI were obtained by taking the antilog of the difference in the log transformed lease square (LS) Means.||0.4301|0.3043|
72625443|NCT01690273|144780224|SUPERIORITY_OR_OTHER|||||||0.643|||||||Mixed Models Analysis|||||||0.643
72528275|NCT00808132|144587197|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Osteocalcin: Month 6, ANCOVA model was used with treatment and region as factors, and baseline as covariate.||||<0.001
72528276|NCT00808132|144587197|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Osteocalcin: Month 6, ANCOVA model was used with treatment and region as factors, and baseline as covariate.||||<0.001
72528277|NCT00808132|144587197|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Osteocalcin: Month 12, ANCOVA model was used with treatment and region as factors, and baseline as covariate.||||<0.001
72407414|NCT02566759|144323374|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Ratio|1.799|||||TWO_SIDED|90.0|1.4625|2.2116||||||The point estimate and CI were obtained by taking the antilog of the difference in the log transformed LS Means.||2.2116|1.4625|
72407415|NCT02566759|144323377|SUPERIORITY_OR_OTHER_LEGACY||Slope|0.872|||||TWO_SIDED|90.0|0.8145|0.9296||||||Dose proportionality was evaluated using the following power model: ln (PK Parameter) = a+b\*ln (dose), where a and b are the intercept and slope of the line, respectively. Dose proportionality was declared when the 90 % CI of the slope lies entirely within the critical region (0.9483, 1.0517) for the dose range of 10 mg to 750 mg.||0.9296|0.8145|
72407416|NCT02566759|144323377|SUPERIORITY_OR_OTHER_LEGACY||Slope|0.9135|||||TWO_SIDED|90.0|0.8062|1.0209|||Power model|||Dose proportionality was evaluated using the following power model: ln (PK Parameter) = a+b\*ln (dose), where a and b were the intercept and slope of the line, respectively. Dose proportionality was declared when the 90% CI of the slope lies entirely within the critical region (0.9139, 1.0861) for the dose range of 30 mg to 400 mg.||1.0209|0.8062|
72407417|NCT02566759|144323377|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Ratio|0.5|||||TWO_SIDED|90.0|0.4324|0.5777||||||The point estimate and CI were obtained by taking the antilog of the difference in the log transformed LS Means.||0.5777|0.4324|
72407418|NCT02566759|144323377|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Ratio|2.563|||||TWO_SIDED|90.0|2.1|3.1275||||||The point estimate and CI were obtained by taking the antilog of the difference in the log transformed LS Means.||3.1275|2.1000|
72407419|NCT02566759|144323378|SUPERIORITY_OR_OTHER_LEGACY||Slope|0.8505|||<|0.001|TWO_SIDED|90.0|0.7925|0.9084|||Power model|||Dose proportionality was evaluated using the following power model: ln (PK Parameter) = a+b\*ln (dose), where a and b are the intercept and slope of the line, respectively. Dose proportionality was declared when the 90 % CI of the slope lies entirely within the critical region (0.9483, 1.0517) for the dose range of 10 mg to 750 mg.||0.9084|0.7925|<0.001
72407420|NCT02566759|144323378|SUPERIORITY_OR_OTHER_LEGACY||Slope|0.8415|||<|0.001|TWO_SIDED|90.0|0.7618|0.9212|||Power model|||Dose proportionality was evaluated using the following power model: ln (PK Parameter) = a+b\*ln (dose), where a and b were the intercept and slope of the line, respectively. Dose proportionality was declared when the 90% CI of the slope lies entirely within the critical region (0.9139, 1.0861) for the dose range of 30 mg to 400 mg.||0.9212|0.7618|<0.001
72407421|NCT02566759|144323378|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Ratio|0.543|||||TWO_SIDED|90.0|0.4797|0.6149||||||The point estimate and CI were obtained by taking the antilog of the difference in the log transformed LS Means.||0.6149|0.4797|
72407422|NCT02566759|144323378|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Ratio|2.336|||||TWO_SIDED|90.0|1.9592|2.7854||||||The point estimate and CI were obtained by taking the antilog of the difference in the log transformed LS Means.||2.7854|1.9592|
72528278|NCT00808132|144587197|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Osteocalcin: Month 12, ANCOVA model was used with treatment and region as factors, and baseline as covariate.||||<0.001
72528279|NCT00808132|144587197|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Osteocalcin: Month 6, ANCOVA model was used with treatment and region as factors, and baseline as covariate.||||<0.001
72528280|NCT00808132|144587197|SUPERIORITY_OR_OTHER|||||||0.0016|TWO_SIDED||||||ANCOVA|||Osteocalcin: Month 12, ANCOVA model was used with treatment and region as factors, and baseline as covariate.||||0.0016
72528281|NCT00808132|144587197|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Osteocalcin: Month 6, ANCOVA model was used with treatment and region as factors, and baseline as covariate.||||<0.001
72528282|NCT00808132|144587197|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Osteocalcin: Month 12, ANCOVA model was used with treatment and region as factors, and baseline as covariate.||||<0.001
72528283|NCT00808132|144587197|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||C-Telopeptide: Month 6, ANCOVA model was used with treatment and region as factors, and baseline as covariate.||||<0.001
72625444|NCT01690273|144780224|SUPERIORITY_OR_OTHER|||||||0.999|||||||Mixed Models Analysis|||||||0.999
72625445|NCT01690273|144780225|SUPERIORITY_OR_OTHER|||||||0.787|||||||Mixed Models Analysis|||||||0.787
72625446|NCT01690273|144780225|SUPERIORITY_OR_OTHER|||||||0.408|||||||Mixed Models Analysis|||||||0.408
72625447|NCT01690273|144780225|SUPERIORITY_OR_OTHER|||||||0.157|||||||Mixed Models Analysis|||||||0.157
72407423|NCT01126541|144323381|NON_INFERIORITY_OR_EQUIVALENCE|Primary objective to demonstrate noninferiority of retreatment with one 1000 mg rituximab infusion. Mean ±SD of the DAS28-CRP AUC at 24 months = 2218 ±967 (based on EDWARDS, REFLEX and DANCER study data). H0 (null hypothesis): Arm B - Arm A \>20%. H1: Arm B - Arm A ≤ 20%. Power = 80%; Larger difference clinically acceptable = 20% = 444; Significance level of 2.5% (one-sided).||||||0.465|||||||Wilcoxon (Mann-Whitney)|||Change from Day 1 to Week 24 (initial treatment)||||0.465
72528284|NCT00808132|144587197|SUPERIORITY_OR_OTHER|||||||0.1058|TWO_SIDED||||||ANCOVA|||C-Telopeptide: Month 6, ANCOVA model was used with treatment and region as factors, and baseline as covariate.||||0.1058
72528285|NCT00808132|144587197|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||C-Telopeptide: Month 12, ANCOVA model was used with treatment and region as factors, and baseline as covariate.||||<0.001
72528286|NCT00808132|144587197|SUPERIORITY_OR_OTHER|||||||0.0024|TWO_SIDED||||||ANCOVA|||C-Telopeptide: Month 12, ANCOVA model was used with treatment and region as factors, and baseline as covariate.||||0.0024
72528287|NCT00808132|144587197|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||C-Telopeptide: Month 6, ANCOVA model was used with treatment and region as factors, and baseline as covariate.||||<0.001
72407424|NCT01126541|144323381|NON_INFERIORITY_OR_EQUIVALENCE|Primary objective to demonstrate noninferiority of retreatment with one 1000 mg rituximab infusion. Mean ±SD of the DAS28-CRP AUC at 24 months = 2218 ±967 (based on EDWARDS, REFLEX and DANCER study data). H0 (null hypothesis): Arm B - Arm A \>20%. H1: Arm B - Arm A ≤ 20%. Power = 80%; Larger difference clinically acceptable = 20% = 444; Significance level of 2.5% (one-sided)||||||0.161|||||||Wilcoxon (Mann-Whitney)|||Arm A vs. Arm B: Change from 1st retreatment to 24 weeks after||||0.161
72528288|NCT00808132|144587197|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||C-Telopeptide: Month 6, ANCOVA model was used with treatment and region as factors, and baseline as covariate.||||<0.001
72528289|NCT00808132|144587197|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||C-Telopeptide: Month 12, ANCOVA model was used with treatment and region as factors, and baseline as covariate.||||<0.001
72528290|NCT00808132|144587197|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||C-Telopeptide: Month 12, ANCOVA model was used with treatment and region as factors, and baseline as covariate.||||<0.001
72528291|NCT00808132|144587197|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||C-Telopeptide: Month 6, ANCOVA model was used with treatment and region as factors, and baseline as covariate.||||<0.001
72528292|NCT00808132|144587197|SUPERIORITY_OR_OTHER|||||||0.0012|TWO_SIDED||||||ANCOVA|||C-Telopeptide: Month 12, ANCOVA model was used with treatment and region as factors, and baseline as covariate.||||0.0012
72528293|NCT00808132|144587197|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||C-Telopeptide: Month 6, ANCOVA model was used with treatment and region as factors, and baseline as covariate.||||<0.001
72528294|NCT00808132|144587197|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||C-Telopeptide: Month 12, ANCOVA model was used with treatment and region as factors, and baseline as covariate.||||<0.001
72528295|NCT00808132|144587197|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||P1NP: Month 6, ANCOVA model was used with treatment and region as factors, and baseline as covariate.||||<0.001
72528296|NCT00808132|144587197|SUPERIORITY_OR_OTHER|||||||0.0029|TWO_SIDED||||||ANCOVA|||P1NP: Month 6, ANCOVA model was used with treatment and region as factors, and baseline as covariate.||||0.0029
72528297|NCT00808132|144587197|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||P1NP: Month 12, ANCOVA model was used with treatment and region as factors, and baseline as covariate.||||<0.001
72528298|NCT00808132|144587197|SUPERIORITY_OR_OTHER|||||||0.0046|TWO_SIDED||||||ANCOVA|||P1NP: Month 12, ANCOVA model was used with treatment and region as factors, and baseline as covariate.||||0.0046
72528299|NCT00808132|144587197|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||P1NP: Month 6, ANCOVA model was used with treatment and region as factors, and baseline as covariate.||||<0.001
72528300|NCT00808132|144587197|SUPERIORITY_OR_OTHER|||||||0.0043|TWO_SIDED||||||ANCOVA|||P1NP: Month 6, ANCOVA model was used with treatment and region as factors, and baseline as covariate.||||0.0043
72528301|NCT00808132|144587197|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||P1NP: Month 12, ANCOVA model was used with treatment and region as factors, and baseline as covariate.||||<0.001
72528302|NCT00808132|144587197|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||P1NP: Month 12, ANCOVA model was used with treatment and region as factors, and baseline as covariate.||||<0.001
72528303|NCT00808132|144587197|SUPERIORITY_OR_OTHER|||||||0.0016|TWO_SIDED||||||ANCOVA|||P1NP: Month 6, ANCOVA model was used with treatment and region as factors, and baseline as covariate.||||0.0016
72528304|NCT00808132|144587197|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||P1NP: Month 12, ANCOVA model was used with treatment and region as factors, and baseline as covariate.||||<0.001
72528305|NCT00808132|144587197|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||P1NP: Month 6, ANCOVA model was used with treatment and region as factors, and baseline as covariate.||||<0.001
72528306|NCT00808132|144587197|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||P1NP: Month 12, ANCOVA model was used with treatment and region as factors, and baseline as covariate.||||<0.001
72528307|NCT00808132|144587199|SUPERIORITY_OR_OTHER|||||||0.546|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 1-4: Cochran-Mantel-Haenszel test was stratified by baseline value.||||0.546
72528308|NCT00808132|144587199|SUPERIORITY_OR_OTHER|||||||0.821|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 5-8: Cochran-Mantel-Haenszel test was stratified by baseline value.||||0.821
72528309|NCT00808132|144587199|SUPERIORITY_OR_OTHER|||||||0.698|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 9-12: Cochran-Mantel-Haenszel test was stratified by baseline value.||||0.698
72528310|NCT00808132|144587199|SUPERIORITY_OR_OTHER|||||||0.446|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 13-16: Cochran-Mantel-Haenszel test was stratified by baseline value.||||0.446
72528311|NCT00808132|144587199|SUPERIORITY_OR_OTHER|||||||0.892|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 17-20: Cochran-Mantel-Haenszel test was stratified by baseline value.||||0.892
72528312|NCT00808132|144587199|SUPERIORITY_OR_OTHER|||||||0.81|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 21-24: Cochran-Mantel-Haenszel test was stratified by baseline value.||||0.810
72528313|NCT00808132|144587199|SUPERIORITY_OR_OTHER|||||||0.473|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 25-28: Cochran-Mantel-Haenszel test was stratified by baseline value.||||0.473
72528314|NCT00808132|144587199|SUPERIORITY_OR_OTHER|||||||0.03|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 29-32: Cochran-Mantel-Haenszel test was stratified by baseline value.||||0.030
72625448|NCT01690273|144780225|SUPERIORITY_OR_OTHER|||||||0.835|||||||Mixed Models Analysis|||||||0.835
72407425|NCT01126541|144323381|NON_INFERIORITY_OR_EQUIVALENCE|Primary objective to demonstrate noninferiority of retreatment with one 1000 mg rituximab infusion. Mean ±SD of the DAS28-CRP AUC at 24 months = 2218 ±967 (based on EDWARDS, REFLEX and DANCER study data). H0 (null hypothesis): Arm B - Arm A \>20%. H1: Arm B - Arm A ≤ 20%. Power = 80%; Larger difference clinically acceptable = 20% = 444; Significance level of 2.5% (one-sided)||||||0.524|||||||Student t-test|||Arm A vs. Arm B: Change from 2nd retreatment to 24 weeks after||||0.524
72528315|NCT00808132|144587199|SUPERIORITY_OR_OTHER|||||||0.453|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 33-36: Cochran-Mantel-Haenszel test was stratified by baseline value.||||0.453
72528316|NCT00808132|144587199|SUPERIORITY_OR_OTHER|||||||0.391|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 37-40: Cochran-Mantel-Haenszel test was stratified by baseline value.||||0.391
72571601|NCT02912650|144671802|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-18.58||||0.01|TWO_SIDED|95.0|-32.64|-4.52|||Cochran-Mantel-Haenszel|||At 8 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions, controlling for baseline categorical PSR and gender using table scores.||-4.52|-32.64|0.010
72571602|NCT02912650|144671802|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-18.17|||<|0.001|TWO_SIDED|95.0|-28.44|-7.9|||Cochran-Mantel-Haenszel|||At 8 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions, controlling for baseline categorical PSR and gender using table scores.||-7.90|-28.44|<0.001
72625449|NCT01690273|144780225|SUPERIORITY_OR_OTHER|||||||0.256|||||||Mixed Models Analysis|||||||0.256
72625450|NCT01690273|144780225|SUPERIORITY_OR_OTHER|||||||0.935|||||||Mixed Models Analysis|||||||0.935
72625451|NCT01690273|144780226|SUPERIORITY_OR_OTHER|||||||0.978|||||||Mixed Models Analysis|||||||0.978
72528317|NCT00808132|144587199|SUPERIORITY_OR_OTHER|||||||0.407|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 41-44: Cochran-Mantel-Haenszel test was stratified by baseline value.||||0.407
72528318|NCT00808132|144587199|SUPERIORITY_OR_OTHER|||||||0.644|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 45-48: Cochran-Mantel-Haenszel test was stratified by baseline value.||||0.644
72528319|NCT00808132|144587199|SUPERIORITY_OR_OTHER|||||||0.666|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 49-52: Cochran-Mantel-Haenszel test was stratified by baseline value.||||0.666
72528320|NCT00808132|144587199|SUPERIORITY_OR_OTHER|||||||0.641|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 1-4: Cochran-Mantel-Haenszel test was stratified by baseline value.||||0.641
72528321|NCT00808132|144587199|SUPERIORITY_OR_OTHER|||||||0.361|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 5-8: Cochran-Mantel-Haenszel test was stratified by baseline value.||||0.361
72528322|NCT00808132|144587199|SUPERIORITY_OR_OTHER|||||||0.1|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 9-12: Cochran-Mantel-Haenszel test was stratified by baseline value.||||0.100
72528323|NCT00808132|144587199|SUPERIORITY_OR_OTHER|||||||0.142|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 13-16: Cochran-Mantel-Haenszel test was stratified by baseline value.||||0.142
72528324|NCT00808132|144587199|SUPERIORITY_OR_OTHER|||||||0.906|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 17-20: Cochran-Mantel-Haenszel test was stratified by baseline value.||||0.906
72528325|NCT00808132|144587199|SUPERIORITY_OR_OTHER|||||||0.798|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 21-24: Cochran-Mantel-Haenszel test was stratified by baseline value.||||0.798
72528326|NCT00808132|144587199|SUPERIORITY_OR_OTHER|||||||0.258|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 25-28: Cochran-Mantel-Haenszel test was stratified by baseline value.||||0.258
72528327|NCT00808132|144587199|SUPERIORITY_OR_OTHER|||||||0.058|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 29-32: Cochran-Mantel-Haenszel test was stratified by baseline value.||||0.058
72528328|NCT00808132|144587199|SUPERIORITY_OR_OTHER|||||||0.23|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 33-36: Cochran-Mantel-Haenszel test was stratified by baseline value.||||0.230
72528329|NCT00808132|144587199|SUPERIORITY_OR_OTHER|||||||0.36|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 37-40: Cochran-Mantel-Haenszel test was stratified by baseline value.||||0.360
72528330|NCT00808132|144587199|SUPERIORITY_OR_OTHER|||||||0.892|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 41-44: Cochran-Mantel-Haenszel test was stratified by baseline value.||||0.892
72528331|NCT00808132|144587199|SUPERIORITY_OR_OTHER|||||||0.912|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 45-48: Cochran-Mantel-Haenszel test was stratified by baseline value.||||0.912
72528332|NCT00808132|144587199|SUPERIORITY_OR_OTHER|||||||0.791|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 49-52: Cochran-Mantel-Haenszel test was stratified by baseline value.||||0.791
72528333|NCT00808132|144587200|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.93||||0.253|TWO_SIDED|95.0|-7.96|2.1|||ANCOVA|||Sleep disturbance: ANCOVA model was used with treatment and region as factors and baseline as a covariate.||2.10|-7.96|0.253
72528334|NCT00808132|144587200|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.84||||0.127|TWO_SIDED|95.0|-8.78|1.1|||ANCOVA|||Sleep disturbance: ANCOVA model was used with treatment and region as factors and baseline as a covariate.||1.10|-8.78|0.127
72528335|NCT00808132|144587200|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.15||||0.18|TWO_SIDED|95.0|-7.76|1.46|||ANCOVA|||Snoring: ANCOVA model was used with treatment and region as factors and baseline as a covariate.||1.46|-7.76|0.180
72528336|NCT00808132|144587200|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.67||||0.247|TWO_SIDED|95.0|-7.19|1.85|||ANOVA|||Snoring: ANCOVA model was used with treatment and region as factors and baseline as a covariate.||1.85|-7.19|0.247
72571603|NCT02912650|144671802|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-57.58|||<|0.001|TWO_SIDED|95.0|-70.44|-44.72|||Cochran-Mantel-Haenszel|||At 6 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions, controlling for baseline categorical PSR and gender using table scores.||-44.72|-70.44|<0.001
72625452|NCT01690273|144780226|SUPERIORITY_OR_OTHER|||||||0.169|||||||Mixed Models Analysis|||||||0.169
72625453|NCT01690273|144780226|SUPERIORITY_OR_OTHER|||||||0.002|||||||Mixed Models Analysis|||||||0.002
72625454|NCT01690273|144780226|SUPERIORITY_OR_OTHER|||||||0.993|||||||Mixed Models Analysis|||||||0.993
72625455|NCT01690273|144780226|SUPERIORITY_OR_OTHER|||||||0.105|||||||Mixed Models Analysis|||||||0.105
72625456|NCT01690273|144780226|SUPERIORITY_OR_OTHER|||||||0.335|||||||Mixed Models Analysis|||||||0.335
72625457|NCT01137890|144780274|SUPERIORITY||F-value for main effect of Coc dose|24.9|||<|0.01|TWO_SIDED|||||p-value was calculated as less than 0.01. Note: this is not an attempt to indicate a threshold|ANOVA||F-value for main effect of Cocaine dose on VAQ score|||||<0.01
72625458|NCT01137890|144780274|SUPERIORITY||F-value for main effect of Zon dose|0.34||||0.72|TWO_SIDED||||||ANOVA||F-value for main effect of Zonisamide dose on VAQ score|||||0.72
72407426|NCT01126541|144323382|NON_INFERIORITY_OR_EQUIVALENCE|Primary objective to demonstrate noninferiority of retreatment with one 1000 mg rituximab infusion. Mean plus or minus (±)SD of the DAS28-CRP AUC at 24 months = 2218 ±967 (based on EDWARDS, REFLEX and DANCER study data). H0 (null hypothesis): Arm B - Arm A \>20%. H1: Arm B - Arm A ≤ 20%. Power = 80%; Larger difference clinically acceptable = 20% = 444; Significance level of 2.5% (one-sided)|Adjusted difference|51.38|STANDARD_DEVIATION|92.0|||TWO_SIDED|95.0|-131.22|233.98|||||Covariate analysis with baseline DAS28-CRP value as covariate|||233.98|-131.22|
72407427|NCT01126541|144323402|SUPERIORITY_OR_OTHER|||||||0.389|||||||Wilcoxon (Mann-Whitney)|||Day 1 to Week 104||||0.389
72407428|NCT01126541|144323402|SUPERIORITY_OR_OTHER|||||||0.374|||||||Wilcoxon (Mann-Whitney)|||1st retreatment to Week 104||||0.374
72528337|NCT00808132|144587200|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.63||||0.726|TWO_SIDED|95.0|-4.15|2.9|||ANCOVA|||ASoB: ANCOVA model was used with treatment and region as factors and baseline as a covariate.||2.90|-4.15|0.726
72528338|NCT00808132|144587200|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.17||||0.218|TWO_SIDED|95.0|-5.63|1.29|||ANCOVA|||ASoB: ANCOVA model was used with treatment and region as factors and baseline as a covariate.||1.29|-5.63|0.218
72528339|NCT00808132|144587200|SUPERIORITY_OR_OTHER||LS Mean Difference|0.01||||0.996|TWO_SIDED|95.0|-3.85|3.87|||ANCOVA|||Somnolence: ANCOVA model was used with treatment and region as factors and baseline as a covariate.||3.87|-3.85|0.996
72528340|NCT00808132|144587200|SUPERIORITY_OR_OTHER||LS Mean DIfference|0.83||||0.665|TWO_SIDED|95.0|-2.94|4.6|||ANCOVA|||Somnolence: ANCOVA model was used with treatment and region as factors and baseline as a covariate.||4.60|-2.94|0.665
72528341|NCT00808132|144587200|SUPERIORITY_OR_OTHER||LS Mean Difference|2.76||||0.368|TWO_SIDED|95.0|-3.26|8.78|||ANOVA|||Sleep adequacy: Month 3, ANCOVA model was used with treatment and region as factors and baseline as a covariate.||8.78|-3.26|0.368
72528342|NCT00808132|144587200|SUPERIORITY_OR_OTHER||LS Mean Difference|2.84||||0.345|TWO_SIDED|95.0|-3.07|8.75|||ANCOVA|||Sleep adequacy: ANCOVA model was used with treatment and region as factors and baseline as a covariate.||8.75|-3.07|0.345
72528343|NCT00808132|144587200|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.35||||0.482|TWO_SIDED|95.0|-5.12|2.42|||ANCOVA|||Sleep problem index I: ANCOVA model was used with treatment and region as factors and baseline as a covariate.||2.42|-5.12|0.482
72528344|NCT00808132|144587200|SUPERIORITY_OR_OTHER||LS Mean DIfference|-2.15||||0.254|TWO_SIDED|95.0|-5.86|1.55|||ANCOVA|||Sleep problem index I: ANCOVA model was used with treatment and region as factors and baseline as a covariate.||1.55|-5.86|0.254
72528345|NCT00808132|144587200|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.97||||0.308|TWO_SIDED|95.0|-5.76|1.82|||ANCOVA|||Sleep problem index II: ANCOVA model was used with treatment and region as factors and baseline as a covariate.||1.82|-5.76|0.308
72528346|NCT00808132|144587200|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.48||||0.19|TWO_SIDED|95.0|-6.2|1.23|||ANCOVA|||Sleep problem index II: ANCOVA model was used with treatment and region as factors and baseline as a covariate.||1.23|-6.20|0.190
72625459|NCT01137890|144780274|SUPERIORITY||F-value for main effect of Coc x Zon|0.66||||0.63|TWO_SIDED||||||ANOVA||F-value for main effect of Cocaine x Zonisamide interaction on VAQ scores|||||0.63
72528347|NCT00808132|144587200|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.07||||0.55|TWO_SIDED|95.0|-0.32|0.17|||ANCOVA|||Sleep quantity: ANCOVA model was used with treatment and region as factors and baseline as a covariate.||0.17|-0.32|0.550
72528348|NCT00808132|144587200|SUPERIORITY_OR_OTHER||LS Mean Difference|0.09||||0.477|TWO_SIDED|95.0|-0.15|0.32|||ANCOVA|||Sleep quantity: ANCOVA model was used with treatment and region as factors and baseline as a covariate.||0.32|-0.15|0.477
72528349|NCT00808132|144587202|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANCOVA|||Vasomotor function: ANCOVA model was used with treatment and region as factors and baseline as a covariate.||||<0.001
72528350|NCT00808132|144587202|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANCOVA|||Vasomotor function: ANCOVA model was used with treatment and region as factors and baseline as a covariate.||||<0.001
72528351|NCT00808132|144587202|SUPERIORITY_OR_OTHER|||||||0.68|||||||ANCOVA|||Psychosocial function: ANCOVA model was used with treatment and region as factors and baseline as a covariate.||||0.680
72407429|NCT01126541|144323402|SUPERIORITY_OR_OTHER|||||||0.277|||||||Wilcoxon (Mann-Whitney)|||Weel 24 to Week 104||||0.277
72407430|NCT01126541|144323403|SUPERIORITY_OR_OTHER|||||||0.278|||||||Wilcoxon (Mann-Whitney)|||Total cortisone: Week 24 to Week 104||||0.278
72407431|NCT01126541|144323403|SUPERIORITY_OR_OTHER|||||||0.887|||||||Wilcoxon (Mann-Whitney)|||Oral cortisone: Week 24 to Week 104||||0.887
72407432|NCT01126541|144323403|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||IV cortisone: Week 24 to Week 104||||<0.001
72407433|NCT01513291|144323427|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.4||||0.33153|TWO_SIDED|95.0|-1.3|0.4|||Constrained Longitudinal Analysis (cLDA)||Risk difference is for MK-6096 - Placebo. The cLDA model included terms for treatment, time, treatment-by-time interaction, monthly migraine days during the Screening (Baseline) Period (≤8, \>8) as covariates|||0.4|-1.3|0.33153
72528352|NCT00808132|144587202|SUPERIORITY_OR_OTHER|||||||0.493|||||||ANCOVA|||Psychosocial function: ANCOVA model was used with treatment and region as factors and baseline as a covariate.||||0.493
72528353|NCT00808132|144587202|SUPERIORITY_OR_OTHER|||||||0.698|||||||ANCOVA|||Physical function: ANCOVA model was used with treatment and region as factors and baseline as a covariate.||||0.698
72528354|NCT00808132|144587202|SUPERIORITY_OR_OTHER|||||||0.055|||||||ANCOVA|||Physical function: ANCOVA model was used with treatment and region as factors and baseline as a covariate.||||0.055
72528355|NCT00808132|144587202|SUPERIORITY_OR_OTHER|||||||0.428|||||||ANCOVA|||Sexual function: ANCOVA model was used with treatment and region as factors and baseline as a covariate.||||0.428
72528356|NCT00808132|144587202|SUPERIORITY_OR_OTHER|||||||0.071|||||||ANCOVA|||Sexual function: ANCOVA model was used with treatment and region as factors and baseline as a covariate.||||0.071
72528357|NCT00808132|144587203|SUPERIORITY_OR_OTHER|||||||0.624|TWO_SIDED||||||Fisher Exact|||Week 1-4: The Fisher exact test was used for comparisons between groups.||||0.624
72528358|NCT00808132|144587203|SUPERIORITY_OR_OTHER|||||||0.868|TWO_SIDED||||||Fisher Exact|||Week 5-8: The Fisher exact test was used for comparisons between groups.||||0.868
72528359|NCT00808132|144587203|SUPERIORITY_OR_OTHER|||||||0.087|TWO_SIDED||||||Fisher Exact|||Week 9-12: The Fisher exact test was used for comparisons between groups.||||0.087
72528360|NCT00808132|144587203|SUPERIORITY_OR_OTHER|||||||0.425|TWO_SIDED||||||Fisher Exact|||Week 13-16: The Fisher exact test was used for comparisons between groups.||||0.425
72528361|NCT00808132|144587203|SUPERIORITY_OR_OTHER|||||||0.307|TWO_SIDED||||||Fisher Exact|||Week 17-20: The Fisher exact test was used for comparisons between groups.||||0.307
72528362|NCT00808132|144587203|SUPERIORITY_OR_OTHER|||||||0.689|TWO_SIDED||||||Fisher Exact|||Week 21-24: The Fisher exact test was used for comparisons between groups.||||0.689
72528363|NCT00808132|144587203|SUPERIORITY_OR_OTHER|||||||0.285|TWO_SIDED||||||Fisher Exact|||Week 25-28: The Fisher exact test was used for comparisons between groups.||||0.285
72528364|NCT00808132|144587203|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Fisher Exact|||Week 29-32: The Fisher exact test was used for comparisons between groups.||||1.000
72528365|NCT00808132|144587203|SUPERIORITY_OR_OTHER|||||||0.065|TWO_SIDED||||||Fisher Exact|||Week 33-36: The Fisher exact test was used for comparisons between groups.||||0.065
72528366|NCT00808132|144587203|SUPERIORITY_OR_OTHER|||||||0.014|TWO_SIDED||||||Fisher Exact|||Week 37-40: The Fisher exact test was used for comparisons between groups.||||0.014
72528367|NCT00808132|144587203|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Fisher Exact|||Week 41-44: The Fisher exact test was used for comparisons between groups.||||1.000
72528368|NCT00808132|144587203|SUPERIORITY_OR_OTHER|||||||0.226|TWO_SIDED||||||Fisher Exact|||Week 45-48: The Fisher exact test was used for comparisons between groups.||||0.226
72528369|NCT00808132|144587203|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Fisher Exact|||Week 49-52: The Fisher exact test was used for comparisons between groups.||||1.000
72528370|NCT00808132|144587203|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Fisher Exact|||Week 1-4: The Fisher exact test was used for comparisons between groups.||||< 0.001
72528371|NCT00808132|144587203|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Fisher Exact|||Week 5-8: The Fisher exact test was used for comparisons between groups.||||< 0.001
72528372|NCT00808132|144587203|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Fisher Exact|||Week 9-12: The Fisher exact test was used for comparisons between groups.||||< 0.001
72528373|NCT00808132|144587203|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Fisher Exact|||Week 13-16: The Fisher exact test was used for comparisons between groups.||||< 0.001
72528374|NCT00808132|144587203|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Fisher Exact|||Week 17-20: The Fisher exact test was used for comparisons between groups.||||< 0.001
72528375|NCT00808132|144587203|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Fisher Exact|||Week 21-24: The Fisher exact test was used for comparisons between groups.||||< 0.001
72528376|NCT00808132|144587203|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Fisher Exact|||Week 25-28: The Fisher exact test was used for comparisons between groups.||||< 0.001
72528377|NCT00808132|144587203|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Fisher Exact|||Week 29-32: The Fisher exact test was used for comparisons between groups.||||< 0.001
72528378|NCT00808132|144587203|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Fisher Exact|||Week 33-36: The Fisher exact test was used for comparisons between groups.||||< 0.001
72528379|NCT00808132|144587203|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Fisher Exact|||Week 37-40: The Fisher exact test was used for comparisons between groups.||||< 0.001
72528380|NCT00808132|144587203|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Fisher Exact|||Week 41-44: The Fisher exact test was used for comparisons between groups.||||< 0.001
72528381|NCT00808132|144587203|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Fisher Exact|||Week 45-48: The Fisher exact test was used for comparisons between groups.||||< 0.001
72528382|NCT00808132|144587203|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Fisher Exact|||Week 49-52: The Fisher exact test was used for comparisons between groups.||||< 0.001
72528383|NCT00808132|144587203|SUPERIORITY_OR_OTHER|||||||0.317|TWO_SIDED||||||Fisher Exact|||Week 1-4: The Fisher exact test was used for comparisons between groups.||||0.317
72528384|NCT00808132|144587203|SUPERIORITY_OR_OTHER|||||||0.531|TWO_SIDED||||||Fisher Exact|||Week 5-8: The Fisher exact test was used for comparisons between groups.||||0.531
72528385|NCT00808132|144587203|SUPERIORITY_OR_OTHER|||||||0.61|TWO_SIDED||||||Fisher Exact|||Week 9-12: The Fisher exact test was used for comparisons between groups.||||0.610
72528386|NCT00808132|144587203|SUPERIORITY_OR_OTHER|||||||0.848|TWO_SIDED||||||Fisher Exact|||Week 13-16: The Fisher exact test was used for comparisons between groups.||||0.848
72528387|NCT00808132|144587203|SUPERIORITY_OR_OTHER|||||||0.551|TWO_SIDED||||||Fisher Exact|||Week 17-20: The Fisher exact test was used for comparisons between groups.||||0.551
72528388|NCT00808132|144587203|SUPERIORITY_OR_OTHER|||||||0.3|TWO_SIDED||||||Fisher Exact|||Week 21-24: The Fisher exact test was used for comparisons between groups.||||0.300
72528389|NCT00808132|144587203|SUPERIORITY_OR_OTHER|||||||0.299|TWO_SIDED||||||Fisher Exact|||Week 25-28: The Fisher exact test was used for comparisons between groups.||||0.299
72528390|NCT00808132|144587203|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Fisher Exact|||Week 29-32: The Fisher exact test was used for comparisons between groups.||||1.000
72528391|NCT00808132|144587203|SUPERIORITY_OR_OTHER|||||||0.66|TWO_SIDED||||||Fisher Exact|||Week 33-36: The Fisher exact test was used for comparisons between groups.||||0.660
72528392|NCT00808132|144587203|SUPERIORITY_OR_OTHER|||||||0.199|TWO_SIDED||||||Fisher Exact|||Week 37-40: The Fisher exact test was used for comparisons between groups.||||0.199
72528393|NCT00808132|144587203|SUPERIORITY_OR_OTHER|||||||0.77|TWO_SIDED||||||Fisher Exact|||Week 41-44: The Fisher exact test was used for comparisons between groups.||||0.770
72528394|NCT00808132|144587203|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Fisher Exact|||Week 45-48: The Fisher exact test was used for comparisons between groups.||||1.000
72528395|NCT00808132|144587203|SUPERIORITY_OR_OTHER|||||||0.769|TWO_SIDED||||||Fisher Exact|||Week 49-52: The Fisher exact test was used for comparisons between groups.||||0.769
72528396|NCT00808132|144587203|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Fisher Exact|||Week 1-4: The Fisher exact test was used for comparisons between groups.||||< 0.001
72528397|NCT00808132|144587203|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Fisher Exact|||Week 5-8: The Fisher exact test was used for comparisons between groups.||||< 0.001
72528398|NCT00808132|144587203|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Fisher Exact|||Week 9-12: The Fisher exact test was used for comparisons between groups.||||< 0.001
72528399|NCT00808132|144587203|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Fisher Exact|||Week 13-16: The Fisher exact test was used for comparisons between groups.||||< 0.001
72528400|NCT00808132|144587203|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Fisher Exact|||Week 17-20: The Fisher exact test was used for comparisons between groups.||||< 0.001
72528401|NCT00808132|144587203|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Fisher Exact|||Week 21-24: The Fisher exact test was used for comparisons between groups.||||< 0.001
72528402|NCT00808132|144587203|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Fisher Exact|||Week 25-28: The Fisher exact test was used for comparisons between groups.||||< 0.001
72528403|NCT00808132|144587203|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Fisher Exact|||Week 29-32: The Fisher exact test was used for comparisons between groups.||||< 0.001
72528404|NCT00808132|144587203|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Fisher Exact|||Week 33-36: The Fisher exact test was used for comparisons between groups.||||< 0.001
72571604|NCT02912650|144671802|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-11.28||||0.004|TWO_SIDED|95.0|-18.99|-3.57|||Cochran-Mantel-Haenszel|||At 6 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions, controlling for baseline categorical PSR and gender using table scores.||-3.57|-18.99|0.004
72571605|NCT02912650|144671802|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-28.06|||<|0.001|TWO_SIDED|95.0|-36.77|-19.35|||Cochran-Mantel-Haenszel|||At 6 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions, controlling for baseline categorical PSR and gender using table scores.||-19.35|-36.77|<0.001
72571606|NCT02912650|144671802|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-46.01|||<|0.001|TWO_SIDED|95.0|-59.98|-32.04|||Cochran-Mantel-Haenszel|||At 6 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions, controlling for baseline categorical PSR and gender using table scores.||-32.04|-59.98|<0.001
72625460|NCT01137890|144780275|SUPERIORITY||F-value for main effect of Coc dose|9.91|||<|0.01|TWO_SIDED|||||p-value was calculated as less than 0.01. Note: this is not an attempt to indicate a threshold|ANOVA||F-value for main effect of Cocaine dose on Behavioral Choice measure|||||<0.01
72528405|NCT00808132|144587203|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Fisher Exact|||Week 37-40: The Fisher exact test was used for comparisons between groups.||||< 0.001
72625461|NCT01137890|144780275|SUPERIORITY||F-value for main effect of Zon dose|0.07||||0.93|TWO_SIDED||||||ANOVA||F-value for main effect of Zonisamide dose on Behavioral Choice measure|||||0.93
72407434|NCT01513291|144323428|SUPERIORITY_OR_OTHER||Risk Difference (RD)|9.3|||||TWO_SIDED|95.0|-3.4|21.6|||||Risk difference (MK-6096 - Placebo) was estimated based on the Miettinen \& Nurminen method|||21.6|-3.4|
72528406|NCT00808132|144587203|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Fisher Exact|||Week 41-44: The Fisher exact test was used for comparisons between groups.||||< 0.001
72528407|NCT00808132|144587203|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Fisher Exact|||Week 45-48: The Fisher exact test was used for comparisons between groups.||||< 0.001
72571607|NCT02912650|144671802|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-29.7|||<|0.001|TWO_SIDED|95.0|-43.65|-15.75|||Cochran-Mantel-Haenszel|||At 6 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions, controlling for baseline categorical PSR and gender using table scores.||-15.75|-43.65|<0.001
72571608|NCT02912650|144671802|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-16.94|||<|0.001|TWO_SIDED|95.0|-26.59|-7.29|||Cochran-Mantel-Haenszel|||At 6 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions, controlling for baseline categorical PSR and gender using table scores.||-7.29|-26.59|<0.001
72571609|NCT02912650|144671803|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Gehan-Wilcoxon test|||p-value was calculated by using Gehan-Wilcoxon test, stratified by gender and baseline categorical PSR terms.||||<0.001
72571610|NCT02912650|144671803|SUPERIORITY_OR_OTHER|||||||0.003|||||||Gehan-Wilcoxon test|||p-value was calculated by using Gehan-Wilcoxon test, stratified by gender and baseline categorical PSR terms.||||0.003
72407435|NCT01513291|144323429|SUPERIORITY_OR_OTHER||Risk Difference (RD)|2.3|||||TWO_SIDED|95.0|-4.0|8.9|||||Risk difference (MK-6096 - Placebo) was estimated based on the Miettinen \& Nurminen method|||8.9|-4.0|
72528408|NCT00808132|144587203|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Fisher Exact|||Week 49-52: The Fisher exact test was used for comparisons between groups.||||< 0.001
72528409|NCT03062605|144587206|OTHER|Inequality test||||||0.35||||||Significant at p \< 0.05|McNemar|||Strep Mutans, Baseline-12 Weeks||||0.35
72528410|NCT03062605|144587206|OTHER|Inequality test||||||0.29||||||Significant at p\<0.05|McNemar|||Strep Mutans, Baseline-12 Weeks||||0.29
72528411|NCT03062605|144587206|OTHER|Inequality test||||||0.09||||||Significant at p \< 0.05|McNemar|||Lactobacillus, Baseline-12 Weeks||||0.09
72528412|NCT03062605|144587206|OTHER|Inequality test||||||0.13||||||Significant at p \< 0.05|McNemar|||Lactobacillus, Baseline-12 Weeks||||0.13
72528413|NCT01009333|144587212|SUPERIORITY_OR_OTHER|||||||0.008||95.0|||||Mixed Models Analysis|||||||0.008
72528414|NCT01009333|144587213|SUPERIORITY_OR_OTHER|||||||0.589||95.0|||||Mixed Models Analysis|||||||0.589
72528415|NCT01009333|144587214|SUPERIORITY_OR_OTHER|||||||0.04||95.0|||||Mixed Models Analysis|||||||0.04
72571611|NCT02912650|144671803|SUPERIORITY_OR_OTHER|||||||0.031|||||||Gehan-Wilcoxon test|||p-value was calculated by using Gehan-Wilcoxon test, stratified by gender and baseline categorical PSR terms.||||0.031
72571612|NCT02912650|144671803|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Gehan-Wilcoxon test|||p-value was calculated by using Gehan-Wilcoxon test, stratified by gender and baseline categorical PSR terms.||||<0.001
72571613|NCT02912650|144671803|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Gehan-Wilcoxon test|||p-value was calculated by using Gehan-Wilcoxon test, stratified by gender and baseline categorical PSR terms.||||<0.001
72571614|NCT02912650|144671803|SUPERIORITY_OR_OTHER|||||||0.631|||||||Gehan-Wilcoxon test|||p-value was calculated by using Gehan-Wilcoxon test, stratified by gender and baseline categorical PSR terms.||||0.631
72571615|NCT02912650|144671804|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Gehan-Wilcoxon test|||p-value was calculated by using Gehan-Wilcoxon test, stratified by gender and baseline categorical PSR terms.||||<0.001
72571616|NCT02912650|144671804|SUPERIORITY_OR_OTHER|||||||0.088|||||||Gehan-Wilcoxon test|||p-value was calculated by using Gehan-Wilcoxon test, stratified by gender and baseline categorical PSR terms.||||0.088
72571617|NCT02912650|144671804|SUPERIORITY_OR_OTHER|||||||0.133|||||||Gehan-Wilcoxon test|||p-value was calculated by using Gehan-Wilcoxon test, stratified by gender and baseline categorical PSR terms.||||0.133
72625462|NCT01137890|144780275|SUPERIORITY||F-value for main effect of Coc x Zon|0.24||||0.92|TWO_SIDED||||||ANOVA||F-value for main effect of Cocaine dose x Zonisamide dose interaction on Behavioral Choice measure|||||0.92
72625463|NCT01137890|144780276|SUPERIORITY||t-value for main effect of Group|1.51||||0.16|TWO_SIDED|||||Group (Zonisamide vs Placebo)|t-test, 2 sided|||||||0.16
72528416|NCT01948791|144587215|NON_INFERIORITY_OR_EQUIVALENCE|If the upper limit of the 95% confidence interval of the mean difference between the baseline score and post-baseline score falls on the left of MeanP-MeanB+1.40, the post-baseline noninferiority to baseline can be concluded. If the upper limit of the 95% confidence interval of the mean difference between the baseline score and post-baseline score falls on the left of 0, superiority can be concluded.|||||<|0.001|||||||t-test, 1 sided|||The hypothesis to test the non-inferiority of post-baseline change in ADAS-Cog from baseline was: H0: μP - μB ≥ 1.40, Ha: μP - μB \< 1.40 where μP and μB are the ADAS-Cog score (actual) at 16 weeks of Rivastigmine treatment and the baseline ADAS-Cog score (actual), respectively.||||<0.001
72528417|NCT02074436|144587220|OTHER|||||||0.5|TWO_SIDED|0.001|||||Fisher Exact|||The results are from the first and only interim analysis focusing on the primary endpoint: proportion of patient with major bleeding (Grade 3 and 4) during the study. The interim analysis was performed after 11 patients in each arm were randomized and results were obtained. One-sided fisher's exact test was employed in the analysis. The null hypothesis is the probability of occurring major bleeding is the same for Arm A and Arm B||||0.5
72528418|NCT01955005|144587224|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Fisher Exact|||This was a 2x2 comparison using Fisher's exact due to low expected cell count. Fisher's exact p\<0.001||||<0.001
72528419|NCT01955005|144587225|SUPERIORITY_OR_OTHER||Z score|568.5||||0.73|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.73
72528420|NCT01955005|144587226|SUPERIORITY_OR_OTHER||Table Probability|0.0142||||0.02|TWO_SIDED||||||Fisher's Exact|||||||0.02
72528421|NCT02815982|144587253|SUPERIORITY||Mean Difference (Final Values)|-8.7|||<|0.05|TWO_SIDED|95.0|-14.6|-2.7|||t-test, 2 sided|||||-2.7|-14.6|<.05
72528422|NCT02815982|144587254|SUPERIORITY||Mean Difference (Final Values)|35.6|||<|0.001|TWO_SIDED|95.0|-559.0|630.2||p value was the actual signficance level|t-test, 2 sided|||We compared Post-intervention scores||630.2|-559.0|<.001
72528423|NCT02815982|144587255|SUPERIORITY||Mean Difference (Final Values)|0.47|||<|0.001|TWO_SIDED|95.0|-2.3|3.3||controlling for caregiver BMI at baseline and PCS BMI percentile at baseline|t-test, 2 sided|||We compared Post-intervention BMI||3.3|-2.3|<.001
72528424|NCT02815982|144587256|SUPERIORITY||Mean Difference (Final Values)|-0.12|||<|0.03|TWO_SIDED|95.0|-5.4|5.2||p \< .05 was the threshold|t-test, 2 sided|||We compared Post-intervention scores||5.2|-5.4|<.03
72528425|NCT02815982|144587257|SUPERIORITY||Mean Difference (Final Values)|3.5|||<|0.09|TWO_SIDED|95.0|-4.3|11.3||p \< .05 was threshold|t-test, 2 sided|||||11.3|-4.3|<.09
72528426|NCT02815982|144587258|SUPERIORITY||Mean Difference (Final Values)|-328.6|||<|0.08|TWO_SIDED|95.0|-2868.4|2211.2||p \< .05 threshold,|t-test, 2 sided|||We compared Post-intervention scores||2211.2|-2868.4|<.08
72528427|NCT02815982|144587259|SUPERIORITY||Mean Difference (Final Values)|0.06|||<|0.0001|TWO_SIDED|95.0|0.01|0.11||threshold set at p \< .05|t-test, 2 sided|||We compared Post-intervention scores||.11|.01|<.0001
72528428|NCT02815982|144587260|SUPERIORITY||Mean Difference (Final Values)|-2.85|||<|0.001|TWO_SIDED|95.0|-11.3|5.65||threshold set at p \< .05|t-test, 2 sided|||We compared Post-intervention scores||5.65|-11.3|<.001
72528429|NCT02815982|144587261|SUPERIORITY||Mean Difference (Final Values)|0.01|||<|0.001|TWO_SIDED|95.0|-0.04|0.06||threshold p \< .05|t-test, 2 sided|||We compared Post-intervention scores||.06|-.04|<.001
72625464|NCT01137890|144780276|SUPERIORITY|Day (Day 1-39)|t-value for main effect of Day|-3.2||||0.0015|TWO_SIDED||||||t-test, 2 sided|||||||0.0015
72528430|NCT02815982|144587262|SUPERIORITY||Mean Difference (Final Values)|-348.9|||<|0.12|TWO_SIDED|95.0|-2762.5|2064.8||p \< .05 was the threshold|t-test, 2 sided|||We compared Post-intervention scores||2064.8|-2762.5|<.12
72528431|NCT00352027|144587263|SUPERIORITY_OR_OTHER_LEGACY|||||||0.997|||||||Cox Model|||The association of age with EFS was compared. P values from Score test were computed for the statistical significance.||||0.9970
72528432|NCT00352027|144587266|SUPERIORITY_OR_OTHER_LEGACY|||||||0.997|||||||Cox Model|||||||0.9970
72528433|NCT00352027|144587298|SUPERIORITY_OR_OTHER_LEGACY|||||||0.265||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.265
72528434|NCT00352027|144587298|SUPERIORITY_OR_OTHER_LEGACY|||||||0.057||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.057
72625465|NCT01137890|144780276|SUPERIORITY|Group\*Day interaction|t value for Group x Day interaction|-1.63||||0.1|TWO_SIDED||||||t-test, 2 sided|||||||0.10
72528435|NCT00352027|144587298|SUPERIORITY_OR_OTHER_LEGACY|||||||0.079||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.079
72528436|NCT00352027|144587298|SUPERIORITY_OR_OTHER_LEGACY|||||||0.025||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.025
72528437|NCT00352027|144587298|SUPERIORITY_OR_OTHER_LEGACY|||||||0.68||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.680
72528438|NCT00352027|144587299|SUPERIORITY_OR_OTHER_LEGACY|||||||0.563||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.563
72528439|NCT00352027|144587299|SUPERIORITY_OR_OTHER_LEGACY|||||||0.563||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.563
72528440|NCT00352027|144587299|SUPERIORITY_OR_OTHER_LEGACY|||||||0.563||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.563
72528441|NCT00352027|144587299|SUPERIORITY_OR_OTHER_LEGACY|||||||0.184||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.184
72528442|NCT00352027|144587299|SUPERIORITY_OR_OTHER_LEGACY|||||||0.563||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.563
72528443|NCT00352027|144587300|SUPERIORITY_OR_OTHER_LEGACY|||||||0.319||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.319
72625466|NCT01137890|144780277|SUPERIORITY||F-value for main effect of Coc dose|21.1|||<|0.01|TWO_SIDED|||||p-value was calculated as less than 0.01. Note: this is not an attempt to indicate a threshold|ANOVA||F-value for main effect of Cocaine dose|||||<0.01
72625467|NCT01137890|144780277|SUPERIORITY||F-value for main effect of Zon dose|0.77||||0.48|TWO_SIDED||||||ANOVA||F-value for main effect of Zonisamide dose|||||0.48
72407436|NCT01513291|144323430|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.5||||0.24008|TWO_SIDED|95.0|-1.4|0.4|||Constrained Longitudinal Analysis (cLDA)||Risk difference is for MK-6096 - Placebo. The cLDA model included terms for treatment, time, treatment-by-time interaction, monthly migraine days during the Screening (Baseline) Period (≤8, \>8) as covariates|||0.4|-1.4|0.24008
72528444|NCT00352027|144587300|SUPERIORITY_OR_OTHER_LEGACY|||||||0.01||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.010
72528445|NCT00352027|144587300|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.002
72528446|NCT00352027|144587300|SUPERIORITY_OR_OTHER_LEGACY|||||||0.015||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.015
72528447|NCT00352027|144587300|SUPERIORITY_OR_OTHER_LEGACY|||||||0.588||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.588
72528448|NCT00352027|144587301|SUPERIORITY_OR_OTHER_LEGACY|||||||0.071||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.071
72528449|NCT00352027|144587301|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||<0.001
72528450|NCT00352027|144587301|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||<0.001
72528451|NCT00352027|144587301|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||<0.001
72528452|NCT00352027|144587301|SUPERIORITY_OR_OTHER_LEGACY|||||||0.707||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.707
72528453|NCT00352027|144587302|SUPERIORITY_OR_OTHER_LEGACY|||||||0.042||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.042
72528454|NCT00352027|144587302|SUPERIORITY_OR_OTHER_LEGACY|||||||0.025||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.025
72528455|NCT00352027|144587302|SUPERIORITY_OR_OTHER_LEGACY|||||||0.013||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.013
72571618|NCT02912650|144671804|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Gehan-Wilcoxon test|||p-value was calculated by using Gehan-Wilcoxon test, stratified by gender and baseline categorical PSR terms.||||<0.001
72528456|NCT00352027|144587302|SUPERIORITY_OR_OTHER_LEGACY|||||||0.027||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.027
72528457|NCT00352027|144587302|SUPERIORITY_OR_OTHER_LEGACY|||||||0.243||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.243
72528458|NCT00352027|144587303|SUPERIORITY_OR_OTHER_LEGACY|||||||0.546||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.546
72528459|NCT00352027|144587303|SUPERIORITY_OR_OTHER_LEGACY|||||||0.242||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.242
72571619|NCT02912650|144671804|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Gehan-Wilcoxon test|||p-value was calculated by using Gehan-Wilcoxon test, stratified by gender and baseline categorical PSR terms.||||<0.001
72528460|NCT00352027|144587303|SUPERIORITY_OR_OTHER_LEGACY|||||||0.372||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.372
72528461|NCT00352027|144587303|SUPERIORITY_OR_OTHER_LEGACY|||||||0.503||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.503
72528462|NCT00352027|144587303|SUPERIORITY_OR_OTHER_LEGACY|||||||0.372||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.372
72528463|NCT00352027|144587304|SUPERIORITY_OR_OTHER_LEGACY|||||||0.558||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.558
72528464|NCT00352027|144587304|SUPERIORITY_OR_OTHER_LEGACY|||||||0.039||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.039
72528465|NCT00352027|144587304|SUPERIORITY_OR_OTHER_LEGACY|||||||0.162||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.162
72528466|NCT00352027|144587304|SUPERIORITY_OR_OTHER_LEGACY|||||||0.162||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.162
72528467|NCT00352027|144587305|SUPERIORITY_OR_OTHER_LEGACY|||||||0.381||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.381
72528468|NCT00352027|144587305|SUPERIORITY_OR_OTHER_LEGACY|||||||0.006||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.006
72528469|NCT00352027|144587305|SUPERIORITY_OR_OTHER_LEGACY|||||||0.277||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.277
72528470|NCT00352027|144587305|SUPERIORITY_OR_OTHER_LEGACY|||||||0.134||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.134
72528471|NCT00352027|144587306|SUPERIORITY_OR_OTHER_LEGACY|||||||0.629||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.629
72571620|NCT02912650|144671804|SUPERIORITY_OR_OTHER|||||||0.887|||||||Gehan-Wilcoxon test|||p-value was calculated by using Gehan-Wilcoxon test, stratified by gender and baseline categorical PSR terms.||||0.887
72571621|NCT02912650|144671805|SUPERIORITY_OR_OTHER||LS Mean Difference|0.33|||<|0.001|TWO_SIDED|95.0|0.14|0.52|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.52|0.14|<0.001
72571622|NCT02912650|144671805|SUPERIORITY_OR_OTHER||LS Mean Difference|0.15||||0.034|TWO_SIDED|95.0|0.01|0.28|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.28|0.01|0.034
72528472|NCT00352027|144587306|SUPERIORITY_OR_OTHER_LEGACY|||||||0.629||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.629
72528473|NCT00352027|144587306|SUPERIORITY_OR_OTHER_LEGACY|||||||0.629||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.629
72528474|NCT00352027|144587306|SUPERIORITY_OR_OTHER_LEGACY|||||||0.858||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.858
72528475|NCT00352027|144587307|SUPERIORITY_OR_OTHER_LEGACY|||||||0.744||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.744
72528476|NCT00352027|144587307|SUPERIORITY_OR_OTHER_LEGACY|||||||0.075||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.075
72528477|NCT00352027|144587307|SUPERIORITY_OR_OTHER_LEGACY|||||||0.512||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.512
72528478|NCT00352027|144587307|SUPERIORITY_OR_OTHER_LEGACY|||||||0.088||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.088
72528479|NCT00352027|144587308|SUPERIORITY_OR_OTHER_LEGACY|||||||0.078||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.078
72528480|NCT00352027|144587308|SUPERIORITY_OR_OTHER_LEGACY|||||||0.041||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.041
72528481|NCT00352027|144587308|SUPERIORITY_OR_OTHER_LEGACY|||||||0.078||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.078
72528482|NCT00352027|144587308|SUPERIORITY_OR_OTHER_LEGACY|||||||0.078||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.078
72528483|NCT00352027|144587309|SUPERIORITY_OR_OTHER_LEGACY|||||||0.739||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.739
72528484|NCT00352027|144587309|SUPERIORITY_OR_OTHER_LEGACY|||||||0.739||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.739
72528485|NCT00352027|144587309|SUPERIORITY_OR_OTHER_LEGACY|||||||0.739||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.739
72407437|NCT01513291|144323431|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.2||||0.43093|TWO_SIDED|95.0|0.7|2.0|||Generalized linear mixed effects model||Odds ratio is for MK-6096 / Placebo. The generalized linear mixed effects model included terms for treatment, time, treatment-by-time interaction, monthly migraine days during the Screening (Baseline) Period 1 (≤8, \>8) as covariates.|||2.0|0.7|0.43093
72528486|NCT00352027|144587309|SUPERIORITY_OR_OTHER_LEGACY|||||||0.739||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.739
72528487|NCT00352027|144587310|SUPERIORITY_OR_OTHER_LEGACY|||||||0.933||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.933
72528488|NCT00352027|144587310|SUPERIORITY_OR_OTHER_LEGACY|||||||0.933||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.933
72528489|NCT00352027|144587310|SUPERIORITY_OR_OTHER_LEGACY|||||||0.051||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.051
72528490|NCT00352027|144587310|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0779||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.0779
72528491|NCT00352027|144587311|SUPERIORITY_OR_OTHER_LEGACY|||||||0.415||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.415
72528492|NCT00352027|144587311|SUPERIORITY_OR_OTHER_LEGACY|||||||0.005||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.005
72528493|NCT00352027|144587311|SUPERIORITY_OR_OTHER_LEGACY|||||||0.245||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.245
72528494|NCT00352027|144587311|SUPERIORITY_OR_OTHER_LEGACY|||||||0.005||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.005
72528495|NCT00352027|144587312|SUPERIORITY_OR_OTHER_LEGACY|||||||0.814||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.814
72528496|NCT00352027|144587312|SUPERIORITY_OR_OTHER_LEGACY|||||||0.553||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.553
72528497|NCT00352027|144587312|SUPERIORITY_OR_OTHER_LEGACY|||||||0.173||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.173
72528498|NCT00352027|144587312|SUPERIORITY_OR_OTHER_LEGACY|||||||0.122||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.122
72528499|NCT00352027|144587313|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Generalized Estimating Equations (GEE)|||||||<0.001
72528500|NCT00352027|144587314|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Generallized Estimating Equations (GEE)|||||||<0.001
72528501|NCT00352027|144587315|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Generallized Estimating Equations (GEE)|||||||<0.001
72528502|NCT00352027|144587316|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Generallized Estimating Equations (GEE)|||||||<0.001
72528503|NCT00352027|144587317|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Generallized Estimating Equations (GEE)|||||||<0.001
72528504|NCT00352027|144587318|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Generallized Estimating Equations (GEE)|||||||<0.001
72528505|NCT00352027|144587319|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Generalized Estimating Equations (GEE)|||||||<0.001
72528506|NCT00352027|144587320|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Generalized Estimating Equations (GEE)|||||||<0.001
72528507|NCT00352027|144587321|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Generalized Estimating Equations (GEE)|||||||<0.001
72528508|NCT00352027|144587322|SUPERIORITY_OR_OTHER_LEGACY|||||||0.005|||||||Generalized Estimating Equations (GEE)|||||||0.005
72528509|NCT00352027|144587323|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Generalized Estimating Equations (GEE)|||||||<0.001
72528510|NCT00352027|144587324|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Generalized Estimating Equations (GEE)|||||||<0.001
72528511|NCT00352027|144587325|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Generalized Estimating Equations (GEE)|||||||<0.001
72528512|NCT00352027|144587326|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Generalized Estimating Equations (GEE)|||||||<0.001
72528513|NCT00352027|144587327|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Generalized Estimating Equations (GEE)|||||||<0.001
72528514|NCT00352027|144587328|SUPERIORITY_OR_OTHER_LEGACY|||||||0.908|||||||Log Rank|||||||0.908
72528515|NCT00352027|144587329|SUPERIORITY_OR_OTHER_LEGACY|||||||0.178|||||||Log Rank|||||||0.178
72528516|NCT00352027|144587330|SUPERIORITY_OR_OTHER_LEGACY|||||||0.411|||||||Log Rank|||||||0.411
72528517|NCT00352027|144587332|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4318|||||||Cox Model|||||||0.4318
72528518|NCT00352027|144587333|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2199|||||||Cox Model|||||||0.2199
72528519|NCT00352027|144587334|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8946|||||||Cox Model|||||||0.8946
72528520|NCT00702949|144587339|SUPERIORITY_OR_OTHER|||||||0.007|TWO_SIDED||||||t-test, 2 sided|||Comparing the median numerical change from baseline on hot flash score for Pregabalin 150 Mg with the Placebo.||||0.007
72528521|NCT00702949|144587342|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED||||||t-test, 2 sided|||Comparing the median numerical change from baseline on hot flash score for Pregabalin 75 Mg with the Placebo.||||0.002
72528522|NCT00702949|144587343|SUPERIORITY_OR_OTHER|||||||0.009|TWO_SIDED||||||t-test, 2 sided|||Comparing the median percent change from baseline on hot flash score for Pregabalin 75 Mg with the Placebo.||||0.009
72528523|NCT00702949|144587345|SUPERIORITY_OR_OTHER|||||||0.007|TWO_SIDED||||||t-test, 2 sided|||Comparing the median percent change from baseline on hot flash score for Pregabalin 150 Mg with the Placebo.||||0.007
72528524|NCT04491591|144587350|SUPERIORITY|||||||0.801|||||||Kruskal-Wallis|||||||0.801
72528525|NCT04491591|144587351|SUPERIORITY|||||||0.1336|||||||Fisher Exact|||Reconstruction versus No reconstruction||||0.1336
72528526|NCT04491591|144587351|SUPERIORITY|Immediate reconstruction versus delayed reconstruction||||||0.5505|||||||Fisher Exact|||||||0.5505
72528527|NCT04491591|144587351|SUPERIORITY|||||||0.6178|||||||Fisher Exact|||Flap reconstruction versus Implant reconstruction||||0.6178
72528528|NCT04491591|144587352|SUPERIORITY|||||||0.2317|||||||Fisher Exact|||||||0.2317
72528529|NCT04491591|144587353|SUPERIORITY|||||||0.1052|||||||Fisher Exact|||||||0.1052
72528530|NCT04491591|144587354|OTHER||||||||||||||||||Within subjects pre/post comparison|||
72528531|NCT04491591|144587355|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|||||||<0.001
72528532|NCT04491591|144587357|OTHER||||||||||||||||||Descriptive analysis using mean and standard deviation|||
72528533|NCT04491591|144587358|SUPERIORITY|||||||0.0302|||||||Kruskal-Wallis|||||||0.0302
72528534|NCT04491591|144587359|SUPERIORITY|||||||0.135|||||||Fisher Exact|||Reconstruction versus No reconstruction||||0.135
72528535|NCT04491591|144587359|SUPERIORITY|||||||0.51|||||||Fisher Exact|||Immediate reconstruction versus delayed reconstruction||||0.510
72528536|NCT04491591|144587359|SUPERIORITY|||||||0.469|||||||Fisher Exact|||Flap reconstruction versus Implant reconstruction||||0.469
72528537|NCT04491591|144587360|SUPERIORITY|||||||0.308|||||||Fisher Exact|||||||0.308
72528538|NCT04491591|144587361|SUPERIORITY|||||||0.036|||||||Fisher Exact|||||||0.036
72528539|NCT00135694|144587362|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-13.0|||||TWO_SIDED|90.0|-35.0|10.0||||||||10|-35|
72528540|NCT00135694|144587368|SUPERIORITY_OR_OTHER|||||||0.0183|||||||ANCOVA|Adjusted for immunosuppression dose the subject was receiving at the time of randomization.||||||0.0183
72528541|NCT00135694|144587369|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|Adjusted for immunosuppression dose the subject was receiving at the time of randomization.||||||<0.0001
72528542|NCT02109939|144587426|SUPERIORITY||Mean Difference (Net)|-2.836|STANDARD_ERROR_OF_MEAN|1.758||0.107|TWO_SIDED|95.0|-6.285|0.613|||Mixed Models Analysis|Repeated Measures including week 4.||||0.613|-6.285|0.1070
72528543|NCT02109939|144587427|SUPERIORITY||Mean Difference (Net)|-2.207|STANDARD_ERROR_OF_MEAN|1.653||0.1822|TWO_SIDED|95.0|-5.45|1.036|||Mixed Models Analysis|MMRM with week 4 data.||||1.036|-5.450|0.1822
72528544|NCT02109939|144587428|SUPERIORITY||Odds Ratio (OR)|1.41||||0.0134|TWO_SIDED|95.0|1.07|1.86|||Generalized linear mixed model|The reported outcome measure is the estimated percentage from a generalized linear mixed model, not a simple count of subjects.||||1.86|1.07|0.0134
72528545|NCT02109939|144587431|SUPERIORITY||Odds Ratio (OR)|1.61||||0.0066|TWO_SIDED|95.0|1.14|2.27|||Generalized linear mixed model|The reported outcome measure is the estimated percentage from a generalized linear mixed model, not a simple count of subjects.||||2.27|1.14|0.0066
72528546|NCT02109939|144587434|SUPERIORITY||Odds Ratio (OR)|1.13||||0.2852|TWO_SIDED|95.0|0.9|1.43|||Generalized linear mixed model.|The reported outcome measure is the estimated percentage from a generalized linear mixed model, not a simple count of subjects.||||1.43|0.90|0.2852
72528547|NCT02109939|144587435|SUPERIORITY||Odds Ratio (OR)|1.43||||0.0023|TWO_SIDED|95.0|1.14|1.79|||Generalized linear mixed model|The reported outcome measure is the estimated percentage from a generalized linear mixed model, not a simple count of subjects.||||1.79|1.14|0.0023
72528548|NCT02109939|144587444|SUPERIORITY||Odds Ratio (OR)|1.43||||0.014|TWO_SIDED|95.0|1.07|1.89|||Generalized linear mixed model|The reported outcome measure is the estimated percentage from a generalized linear mixed model, not a simple count of subjects.||||1.89|1.07|0.0140
72528549|NCT02109939|144587445|SUPERIORITY||Odds Ratio (OR)|1.31||||0.0663|TWO_SIDED|95.0|0.98|1.76|||Generalized linear mixed model|The reported outcome measure is the estimated percentage from a generalized linear mixed model, not a simple count of subjects.||||1.76|0.98|0.0663
72528550|NCT01058356|144587456|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.84|STANDARD_ERROR_OF_MEAN|0.4|<|0.05|TWO_SIDED|95.0|0.17|4.15|||Regression, Logistic|||"Null hypothesis: The efficay of the probiotic Lactobacilli (Lacidofil cap®) for the prevention of AAD in adults is not different form the placebo group in multi-center, randomized, placebo-controlled, double-blind trial.~Power calculation:~The assumption of sample size calculation:~difference 18% (8% : 26%) α: 0.05, statistical power: 90%, two sided difference: 18% Compliance: 80%~\- Unadjusted sample size (N=200) 180 + 10(%) drop out = 180 + 180/ (1-0.1)2 = 222.2 Total 220 subjects"||4.15|0.17|<0.05
72528551|NCT01058356|144587457|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.85|STANDARD_ERROR_OF_MEAN|0.27|<|0.05|TWO_SIDED|95.0|0.18|1.55|||Regression, Logistic|||"Null hypothesis: The efficay of the probiotic Lactobacilli (Lacidofil cap®) for the prevention of AAD in adults is not different form the placebo group in multi-center, randomized, placebo-controlled, double-blind trial.~Power calculation:~The assumption of sample size calculation:~difference 18% (8% : 26%) α: 0.05, statistical power: 90%, two sided difference: 18% Compliance: 80%~\- Unadjusted sample size (N=200) 180 + 10(%) drop out = 180 + 180/ (1-0.1)2 = 222.2 Total 220 subjects"||1.55|0.18|<0.05
72528552|NCT02140762|144587490|SUPERIORITY_OR_OTHER||Vaccine Effectiveness|67.0|||<|0.0001|TWO_SIDED|95.0|65.0|69.0|||Generalized Linear Model||VE is based on the relative risk (RR). The Poisson Distribution and Log Link options were used in the generalized linear model to compute the log10 RR and the corresponding confidence interval. Fixed effects: treatment group, strain (and center).|H0 (Null Hypothesis): Vaccine Effectiveness (VE) ≤10%. If the lower limit of the 95% CI for VE is \> 10% the null hypothesis is to be rejected and effectiveness declared. The VE at 1 month after the 2nd injection for each strain is defined as \[1-(% of subjects without bactericidal activity at 1:4 dilution in MenABCWY group / % of subjects without bactericidal activity at 1:4 dilution in MenACWY group)\]x100. The combined VE across all strains will be computed by mean of a generalized linear model.||69|65|<0.0001
72528553|NCT02140762|144587490|OTHER|Vaccine effectiveness at one month after the second vaccination against each of the endemic US N.meningitidis serogroup B strains. Each individual strain data was analysed separately with treatment group as only independent variable in the model.|Vaccine Effectiveness|4.6|||||TWO_SIDED||||||Generalized Linear Model|||vaccine effectiveness\<10% For each strain, vaccine effectiveness (VE) of the MenABCWY compared to MenACWY was evaluated. For each strain, vaccine effectiveness (VE) of the MenABCWY compared to MenACWY was evaluated as VE= \[1- (% not killed/without bactericidal activity strains in ABCWY)/(% of not killed strains/without bactericidal activity strains in ACWY)\*100\].||||
72528554|NCT02140762|144587490|OTHER|Vaccine effectiveness at one month after the second vaccination against each of the endemic US N.meningitidis serogroup B strains. Each individual strain data was analysed separately with treatment group as only independent variable in the model.|Vaccine Effectiveness|12.7|||||TWO_SIDED||||||generalized linear model.|||Vaccine effectiveness \<30% For each strain, vaccine effectiveness (VE) of the MenABCWY compared to MenACWY was evaluated. For each strain, vaccine effectiveness (VE) of the MenABCWY compared to MenACWY was evaluated as VE= \[1- (% not killed/without bactericidal activity strains in ABCWY)/(% of not killed strains/without bactericidal activity strains in ACWY)\*100\].||||
72528555|NCT02140762|144587490|OTHER|Vaccine effectiveness at one month after the second vaccination against each of the endemic US N.meningitidis serogroup B strains. Each individual strain data was analysed separately with treatment group as only independent variable in the model.|Vaccine Effectiveness|18.2|||||TWO_SIDED|||||||||Vaccine effectiveness\<60% For each strain, vaccine effectiveness (VE) of the MenABCWY compared to MenACWY was evaluated. For each strain, vaccine effectiveness (VE) of the MenABCWY compared to MenACWY was evaluated as VE= \[1- (% not killed/without bactericidal activity strains in ABCWY)/(% of not killed strains/without bactericidal activity strains in ACWY)\*100\].||||
72528556|NCT02140762|144587490|OTHER|Vaccine effectiveness at one month after the second vaccination against each of the endemic US N.meningitidis serogroup B strains. Each individual strain data was analysed separately with treatment group as only independent variable in the model.|Vaccine Effectiveness|59.1|||||TWO_SIDED|||||||||Vaccine effectiveness \<100% For each strain, vaccine effectiveness (VE) of the MenABCWY compared to MenACWY was evaluated. For each strain, vaccine effectiveness (VE) of the MenABCWY compared to MenACWY was evaluated as VE= \[1- (% not killed/without bactericidal activity strains in ABCWY)/(% of not killed strains/without bactericidal activity strains in ACWY)\*100\].||||
72528557|NCT02140762|144587491|SUPERIORITY_OR_OTHER||Vaccine effectiveness|44.0|||<|0.0001|TWO_SIDED|95.0|41.0|47.0|||General Linear Model (GLM)||VE is based on the relative risk (RR). The POISSON DISTRIBUTION and LOG LINK options was used in the generalized linear model to compute the log10 RR and the corresponding confidence interval. Fixed effects: treatment group, strain (and center).|H0 (Null Hypothesis): Vaccine Effectiveness (VE) ≤10%. If the LL of the 95% CI for VE is \> 10% the null hypothesis is to be rejected and effectiveness declared. The VE at 4 months after the second injection for each strain is defined as \[1 - (% of subjects without bactericidal activity at 1:4 dilution in MenABCWY group / % of subjects without bactericidal activity at 1:4 dilution in MenACWY group)\] x 100.The combined VE across all strains will be computed by mean of a generalized linear model.||47|41|< 0.0001
72528558|NCT02140762|144587491|OTHER|Vaccine effectiveness at one month after the second vaccination against each of the endemic US N.meningitidis serogroup B strains. Each individual strain data was analysed separately with treatment group as only independent variable in the model.|Vaccine Effectiveness|9.1|||||TWO_SIDED|||||||||Vaccine effectiveness\<10% For each strain, vaccine effectiveness (VE) of the MenABCWY compared to MenACWY was evaluated. For each strain, vaccine effectiveness (VE) of the MenABCWY compared to MenACWY was evaluated as VE= \[1- (% not killed/without bactericidal activity at 1:4 dilution in MenABCWY group)/(% of not killed strains/without bactericidal activity in ACWY group)\*100\].||||
72571623|NCT02912650|144671805|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0||||0.963|TWO_SIDED|95.0|-0.13|0.14|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.14|-0.13|0.963
72571624|NCT02912650|144671805|SUPERIORITY_OR_OTHER||LS Mean Difference|0.18||||0.062|TWO_SIDED|95.0|-0.01|0.37|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.37|-0.01|0.062
72528559|NCT02140762|144587491|OTHER|Vaccine effectiveness at one month after the second vaccination against each of the endemic US N.meningitidis serogroup B strains. Each individual strain data was analysed separately with treatment group as only independent variable in the model.|Vaccine Effectiveness|22.7|||||TWO_SIDED|||||||||Vaccine effectiveness\<30% For each strain, vaccine effectiveness (VE) of the MenABCWY compared to MenACWY was evaluated. For each strain, vaccine effectiveness (VE) of the MenABCWY compared to MenACWY was evaluated as VE= \[1- (% not killed/without bactericidal activity at 1:4 dilution in MenABCWY group)/(% of not killed strains/without bactericidal activity in ACWY group)\*100\].||||
72528560|NCT02140762|144587491|OTHER|Vaccine effectiveness at one month after the second vaccination against each of the endemic US N.meningitidis serogroup B strains. Each individual strain data was analysed separately with treatment group as only independent variable in the model.|Vaccine Effectiveness|19.1|||||TWO_SIDED|||||||||Vaccine effectiveness\<60% For each strain, vaccine effectiveness (VE) of the MenABCWY compared to MenACWY was evaluated. For each strain, vaccine effectiveness (VE) of the MenABCWY compared to MenACWY was evaluated as VE= \[1- (% not killed/without bactericidal activity at 1:4 dilution in MenABCWY group)/(% of not killed strains/without bactericidal activity in ACWY group)\*100\].||||
72528561|NCT02140762|144587491|OTHER|Vaccine effectiveness at one month after the second vaccination against each of the endemic US N.meningitidis serogroup B strains. Each individual strain data was analysed separately with treatment group as only independent variable in the model.|Vaccine Effectiveness|38.2|||||TWO_SIDED|||||||||Vaccine effectiveness\<100% For each strain, vaccine effectiveness (VE) of the MenABCWY compared to MenACWY was evaluated. For each strain, vaccine effectiveness (VE) of the MenABCWY compared to MenACWY was evaluated as VE= \[1- (% not killed/without bactericidal activity at 1:4 dilution in MenABCWY group)/(% of not killed strains/without bactericidal activity in ACWY group)\*100\].||||
72528562|NCT02140762|144587492|SUPERIORITY_OR_OTHER||Vaccine Effectiveness|46.0|||<|0.0001|TWO_SIDED|95.0|43.0|49.0|||Generalized Linear Model||VE is based on the relative risk (RR).The Poisson Distribution and Log Link options were used in the generalized linear model to compute the log10 RR and the corresponding confidence interval. Fixed effects:treatment group, strain (and center).|H0 (Null Hypothesis): Vaccine Effectiveness (VE) ≤ 10%. If the lower limit of the 95% CI for VE is \>10% the null hypothesis is to be rejected and effectiveness declared. The VE at 1 month after the 2nd injection for each strain is defined as \[1-(% of subjects without bactericidal activity at 1:8 dilution in MenABCWY group / % of subjects without bactericidal activity at 1:8 dilution in MenACWY group)\]x100. The combined VE across all strains will be computed by mean of a generalized linear model.||49|43|<0.0001
72528563|NCT02140762|144587492|OTHER|Vaccine effectiveness at one month after the second vaccination against each of the endemic US N.meningitidis serogroup B strains. Each individual strain data was analysed separately with treatment group as only independent variable in the model.|Vaccine Effectiveness|25.5|||||TWO_SIDED|||||||||Vaccine effectiveness\<10% For each strain, vaccine effectiveness (VE) of the MenABCWY compared to MenACWY was evaluated. For each strain, vaccine effectiveness (VE) of the MenABCWY compared to MenACWY was evaluated as VE= \[1- (% not killed/without bactericidal activity at 1:8 dilution in MenABCWY group)/(% of not killed strains/without bactericidal activity in ACWY group)\*100\].||||
72528564|NCT02140762|144587492|OTHER|For each strain, vaccine effectiveness (VE) of the MenABCWY compared to MenACWY was evaluated. For each strain, vaccine effectiveness (VE) of the MenABCWY compared to MenACWY was evaluated as VE= \[1- (% not killed/without bactericidal activity at 1:8 dilution in MenABCWY group)/(% of not killed strains/without bactericidal activity in ACWY group)\*100\].|Vaccine Effectiveness|19.1|||||TWO_SIDED|||||||||Vaccine effectiveness\<30%||||
72528565|NCT02140762|144587492|OTHER|Vaccine effectiveness at one month after the second vaccination against each of the endemic US N.meningitidis serogroup B strains. Each individual strain data was analysed separately with treatment group as only independent variable in the model.|Vaccine Effectiveness|10.9|||||TWO_SIDED|||||||||Vaccine effectiveness\<60% For each strain, vaccine effectiveness (VE) of the MenABCWY compared to MenACWY was evaluated. For each strain, vaccine effectiveness (VE) of the MenABCWY compared to MenACWY was evaluated as VE= \[1- (% not killed/without bactericidal activity at 1:8 dilution in MenABCWY group)/(% of not killed strains/without bactericidal activity in ACWY group)\*100\].||||
72528566|NCT02140762|144587492|OTHER|Vaccine effectiveness at one month after the second vaccination against each of the endemic US N.meningitidis serogroup B strains. Each individual strain data was analysed separately with treatment group as only independent variable in the model.|Vaccine Effectiveness|40.9|||||TWO_SIDED|||||||||Vaccine effectiveness\<100% For each strain, vaccine effectiveness (VE) of the MenABCWY compared to MenACWY was evaluated. For each strain, vaccine effectiveness (VE) of the MenABCWY compared to MenACWY was evaluated as VE= \[1- (% not killed/without bactericidal activity at 1:8 dilution in MenABCWY group)/(% of not killed strains/without bactericidal activity in ACWY group)\*100\].||||
72528567|NCT02140762|144587493|SUPERIORITY_OR_OTHER||Vaccine Effectiveness|20.0|||<|0.0001|TWO_SIDED|95.0|16.0|23.0||VE is based on the relative risk (RR). The POISSON DISTRIBUTION and LOG LINK options was used in the generalized linear model to compute the log10 RR and the corresponding confidence interval. Fixed effects: treatment group, strain (and center).|Generalized Linear Model||VE is based on the relative risk (RR). The POISSON DISTRIBUTION and LOG LINK options was used in the generalized linear model to compute the log10 RR and the corresponding confidence interval. Fixed effects: treatment group, strain (and center).|H0 (Null Hypothesis): Vaccine Effectiveness (VE) ≤10%. If the lower limit of 95% CI for VE is \> 10% the null hypothesis is to be rejected and effectiveness declared. The VE at 4 months after the 2nd injection for each strain is defined as \[1 - (% of subjects without bactericidal activity at 1:8 dilution in MenABCWY group/% of subjects without bactericidal activity at 1:8 dilution in MenACWY group)\] x 100. The combined VE across all strains was computed by mean of a generalized linear model.||23|16|< 0.0001
72625468|NCT01137890|144780277|SUPERIORITY||F-value for the main effect of Zon x Coc|0.93||||0.46|TWO_SIDED||||||ANOVA||F-value for main effect of Zonisamide x Cocaine interaction on drug value (i.e., street value) measurement|||||0.46
72625469|NCT00583219|144780278|SUPERIORITY_OR_OTHER|||||||0.004|||||||Wilcoxon (Mann-Whitney)|||P value change from baseline at one month||||0.004
72625470|NCT00583219|144780278|SUPERIORITY_OR_OTHER|||||||0.81|||||||Wilcoxon (Mann-Whitney)|||P value change from baseline to 3 months||||0.81
72625471|NCT00583219|144780279|SUPERIORITY_OR_OTHER|||||||0.21|||||||Wilcoxon (Mann-Whitney)|||P value change from baseline to 1 month||||0.21
72625472|NCT00583219|144780279|SUPERIORITY_OR_OTHER|||||||0.43|||||||Wilcoxon (Mann-Whitney)|||P value change from baseline to 3 months||||0.43
72571625|NCT02912650|144671805|SUPERIORITY_OR_OTHER||LS Mean Difference|0.32||||0.001|TWO_SIDED|95.0|0.13|0.52|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.52|0.13|0.001
72571626|NCT02912650|144671805|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.14||||0.04|TWO_SIDED|95.0|-0.28|-0.01|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||-0.01|-0.28|0.040
72571627|NCT02912650|144671805|SUPERIORITY_OR_OTHER||LS Mean Difference|0.99|||<|0.001|TWO_SIDED|95.0|0.7|1.27|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.27|0.70|<0.001
72571628|NCT02912650|144671805|SUPERIORITY_OR_OTHER||LS Mean Difference|0.17||||0.095|TWO_SIDED|95.0|-0.03|0.37|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.37|-0.03|0.095
72571629|NCT02912650|144671805|SUPERIORITY_OR_OTHER||LS Mean Difference|0.09||||0.414|TWO_SIDED|95.0|-0.12|0.29|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.29|-0.12|0.414
72625473|NCT00583219|144780281|SUPERIORITY_OR_OTHER|||||||0.005|||||||Wilcoxon (Mann-Whitney)|||P value change from baseline||||0.005
72571630|NCT02912650|144671805|SUPERIORITY_OR_OTHER||LS Mean Difference|0.81|||<|0.001|TWO_SIDED|95.0|0.52|1.1|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.10|0.52|<0.001
72571631|NCT02912650|144671805|SUPERIORITY_OR_OTHER||LS Mean Difference|0.9|||<|0.001|TWO_SIDED|95.0|0.61|1.19|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.19|0.61|<0.001
72571632|NCT02912650|144671805|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.09||||0.406|TWO_SIDED|95.0|-0.29|0.12|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.12|-0.29|0.406
72571633|NCT02912650|144671805|SUPERIORITY_OR_OTHER||LS Mean Difference|1.75|||<|0.001|TWO_SIDED|95.0|1.4|2.09|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||2.09|1.40|<0.001
72571634|NCT02912650|144671805|SUPERIORITY_OR_OTHER||LS Mean Difference|0.34||||0.006|TWO_SIDED|95.0|0.1|0.58|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.58|0.10|0.006
72571635|NCT02912650|144671805|SUPERIORITY_OR_OTHER||LS Mean Difference|0.33||||0.009|TWO_SIDED|95.0|0.08|0.57|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.57|0.08|0.009
72571636|NCT02912650|144671805|SUPERIORITY_OR_OTHER||LS Mean Difference|1.41|||<|0.001|TWO_SIDED|95.0|1.07|1.75|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.75|1.07|<0.001
72571637|NCT02912650|144671805|SUPERIORITY_OR_OTHER||LS Mean Difference|1.42|||<|0.001|TWO_SIDED|95.0|1.08|1.77|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.77|1.08|<0.001
72571638|NCT02912650|144671805|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.01||||0.908|TWO_SIDED|95.0|-0.26|0.23|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.23|-0.26|0.908
72571639|NCT02912650|144671805|SUPERIORITY_OR_OTHER||LS Mean Difference|1.99|||<|0.001|TWO_SIDED|95.0|1.64|2.35|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||2.35|1.64|<0.001
72571640|NCT02912650|144671805|SUPERIORITY_OR_OTHER||LS Mean Difference|0.39||||0.002|TWO_SIDED|95.0|0.15|0.64|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.64|0.15|0.002
72625474|NCT00583219|144780282|SUPERIORITY_OR_OTHER|||||||0.22|||||||Wilcoxon (Mann-Whitney)|||P value change from baseline||||0.22
72625475|NCT00583219|144780283|SUPERIORITY_OR_OTHER|||||||0.24|||||||Wilcoxon (Mann-Whitney)|||P value change from baseline to 1 month||||0.24
72571641|NCT02912650|144671805|SUPERIORITY_OR_OTHER||LS Mean Difference|0.57|||<|0.001|TWO_SIDED|95.0|0.32|0.82|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.82|0.32|<0.001
72571642|NCT02912650|144671805|SUPERIORITY_OR_OTHER||LS Mean Difference|1.6|||<|0.001|TWO_SIDED|95.0|1.25|1.95|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.95|1.25|<0.001
72571643|NCT02912650|144671805|SUPERIORITY_OR_OTHER||LS Mean Difference|1.42|||<|0.001|TWO_SIDED|95.0|1.07|1.78|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.78|1.07|<0.001
72571644|NCT02912650|144671805|SUPERIORITY_OR_OTHER||LS Mean Difference|0.18||||0.157|TWO_SIDED|95.0|-0.07|0.43|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.43|-0.07|0.157
72571645|NCT02912650|144671805|SUPERIORITY_OR_OTHER||LS Mean Difference|2.1|||<|0.001|TWO_SIDED|95.0|1.73|2.48|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||2.48|1.73|<0.001
72625476|NCT00583219|144780283|SUPERIORITY_OR_OTHER|||||||0.14|||||||Wilcoxon (Mann-Whitney)|||P value change from baseline to 3 months||||0.14
72625477|NCT00583219|144780284|SUPERIORITY_OR_OTHER|||||||0.24|||||||Wilcoxon (Mann-Whitney)|||P value change from baseline to 1 month||||0.24
72625478|NCT00583219|144780284|SUPERIORITY_OR_OTHER|||||||0.033|||||||Wilcoxon (Mann-Whitney)|||P value change from baseline to 3 months||||0.033
72625479|NCT00583219|144780285|SUPERIORITY_OR_OTHER||||||>|0.99|||||||Exact binomial sign test|||P value change from baseline to 1 month||||>0.99
72625480|NCT00583219|144780285|SUPERIORITY_OR_OTHER|||||||0.25|||||||exact binomial sign test|||P value change from baseline to 3 months||||0.25
72625481|NCT00583219|144780287|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||P value change from baseline to one month||||<0.001
72625482|NCT00583219|144780288|SUPERIORITY_OR_OTHER|||||||0.004|||||||Wilcoxon (Mann-Whitney)|||P value change from baseline||||0.004
72528568|NCT02140762|144587493|OTHER|Vaccine effectiveness at one month after the second vaccination against each of the endemic US N.meningitidis serogroup B strains. Each individual strain data was analysed separately with treatment group as only independent variable in the model.|Vaccine Effectiveness|36.4|||||TWO_SIDED|||||||||Vaccine effectiveness\<10% For each strain, vaccine effectiveness (VE) of the MenABCWY compared to MenACWY was evaluated. For each strain, vaccine effectiveness (VE) of the MenABCWY compared to MenACWY was evaluated as VE= \[1- (% not killed/without bactericidal activity at 1:8 dilution in MenABCWY group)/(% of not killed strains/without bactericidal activity in ACWY group)\*100\].||||
72528569|NCT02140762|144587493|OTHER|Vaccine effectiveness at one month after the second vaccination against each of the endemic US N.meningitidis serogroup B strains. Each individual strain data was analysed separately with treatment group as only independent variable in the model.|Vaccine Effectiveness|15.5|||||TWO_SIDED|||||||||Vaccine effectiveness\<30% For each strain, vaccine effectiveness (VE) of the MenABCWY compared to MenACWY was evaluated. For each strain, vaccine effectiveness (VE) of the MenABCWY compared to MenACWY was evaluated as VE= \[1- (% not killed/without bactericidal activity at 1:8 dilution in MenABCWY group)/(% of not killed strains/without bactericidal activity in ACWY group)\*100\].||||
72528570|NCT02140762|144587493|OTHER|Vaccine effectiveness at one month after the second vaccination against each of the endemic US N.meningitidis serogroup B strains. Each individual strain data was analysed separately with treatment group as only independent variable in the model.|Vaccine Effectiveness|20.9|||||TWO_SIDED|||||||||Vaccine effectiveness\<60% For each strain, vaccine effectiveness (VE) of the MenABCWY compared to MenACWY was evaluated. For each strain, vaccine effectiveness (VE) of the MenABCWY compared to MenACWY was evaluated as VE= \[1- (% not killed/without bactericidal activity at 1:8 dilution in MenABCWY group)/(% of not killed strains/without bactericidal activity in ACWY group)\*100\].||||
72528571|NCT02140762|144587493|OTHER|Vaccine effectiveness at one month after the second vaccination against each of the endemic US N.meningitidis serogroup B strains. Each individual strain data was analysed separately with treatment group as only independent variable in the model.|Vaccine Effectiveness|11.8|||||TWO_SIDED|||||||||Vaccine effectiveness\<100% For each strain, vaccine effectiveness (VE) of the MenABCWY compared to MenACWY was evaluated. For each strain, vaccine effectiveness (VE) of the MenABCWY compared to MenACWY was evaluated as VE= \[1- (% not killed/without bactericidal activity at 1:8 dilution in MenABCWY group)/(% of not killed strains/without bactericidal activity in ACWY group)\*100\].||||
72528572|NCT00989664|144587530|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||McNemar|||||||<0.001
72528573|NCT02055976|144587578|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-49.838|STANDARD_ERROR_OF_MEAN|3.775|<|0.001|TWO_SIDED|95.0|-57.335|-42.34|||Mixed Models Analysis|One-sided p-value (adjusted for multiplicity) was derived from the MMRM model.||Adjusted mean difference and 2-sided 95% confidence interval were derived from the mixed-effect model for repeated measures (MMRM) model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-42.340|-57.335|<0.001
72528574|NCT02055976|144587578|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-66.754|STANDARD_ERROR_OF_MEAN|3.912|<|0.001|TWO_SIDED|95.0|-74.523|-58.986|||Mixed Models Analysis|One-sided p-value (adjusted for multiplicity) was derived from the MMRM model.||Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-58.986|-74.523|<0.001
72528575|NCT02055976|144587578|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-71.534|STANDARD_ERROR_OF_MEAN|3.903|<|0.001|TWO_SIDED|95.0|-79.284|-63.784|||Mixed Models Analysis|One-sided p-values (adjusted for multiplicity) was derived from the MMRM model.||Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-63.784|-79.284|<0.001
72528576|NCT02055976|144587578|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-47.531|STANDARD_ERROR_OF_MEAN|4.016|<|0.001|TWO_SIDED|95.0|-55.511|-39.551|||Mixed Models Analysis|One-sided p-values (adjusted for multiplicity) was derived from the MMRM model.||Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-39.551|-55.511|<0.001
72528577|NCT02055976|144587578|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-62.624|STANDARD_ERROR_OF_MEAN|3.993|<|0.001|TWO_SIDED|95.0|-70.557|-54.691|||Mixed Models Analysis|One-sided p-values (adjusted for multiplicity) was derived from the MMRM model.||Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-54.691|-70.557|<0.001
72528578|NCT02055976|144587578|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-64.268|STANDARD_ERROR_OF_MEAN|3.955|<|0.001|TWO_SIDED|95.0|-72.128|-56.409|||Mixed Models Analysis|One-sided p-values (adjusted for multiplicity) was derived from the MMRM model.||Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-56.409|-72.128|<0.001
72571646|NCT02912650|144671805|SUPERIORITY_OR_OTHER||LS Mean Difference|0.37||||0.005|TWO_SIDED|95.0|0.11|0.63|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.63|0.11|0.005
72571647|NCT02912650|144671805|SUPERIORITY_OR_OTHER||LS Mean Difference|0.79|||<|0.001|TWO_SIDED|95.0|0.52|1.05|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.05|0.52|<0.001
72571648|NCT02912650|144671805|SUPERIORITY_OR_OTHER||LS Mean Difference|1.73|||<|0.001|TWO_SIDED|95.0|1.36|2.1|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||2.10|1.36|<0.001
72571649|NCT02912650|144671805|SUPERIORITY_OR_OTHER||LS Mean Difference|1.31|||<|0.001|TWO_SIDED|95.0|0.94|1.69|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.69|0.94|<0.001
72571650|NCT02912650|144671805|SUPERIORITY_OR_OTHER||LS Mean Difference|0.42||||0.002|TWO_SIDED|95.0|0.15|0.68|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.68|0.15|0.002
72571651|NCT02912650|144671805|SUPERIORITY_OR_OTHER||LS Mean Difference|2.06|||<|0.001|TWO_SIDED|95.0|1.67|2.45|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||2.45|1.67|<0.001
72528579|NCT02055976|144587579|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-42.293|STANDARD_ERROR_OF_MEAN|3.587|<|0.001|TWO_SIDED|95.0|-49.417|-35.168|||Mixed Models Analysis|One-sided p-values (adjusted for multiplicity) was derived from the MMRM model.||Adjusted mean difference and 2-sided 95% confidence interval were derived from the mixed-effect model for repeated measures (MMRM) model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-35.168|-49.417|<0.001
72528580|NCT02055976|144587579|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-56.262|STANDARD_ERROR_OF_MEAN|3.696|<|0.001|TWO_SIDED|95.0|-63.603|-48.921|||Mixed Models Analysis|One-sided p-values (adjusted for multiplicity) was derived from the MMRM model.||Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-48.921|-63.603|<0.001
72528581|NCT02055976|144587579|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-61.384|STANDARD_ERROR_OF_MEAN|3.7|<|0.001|TWO_SIDED|95.0|-68.733|-54.035|||Mixed Models Analysis|One-sided p-values (adjusted for multiplicity) was derived from the MMRM model.||Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-54.035|-68.733|<0.001
72528582|NCT02055976|144587579|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-47.578|STANDARD_ERROR_OF_MEAN|4.273|<|0.001|TWO_SIDED|95.0|-56.067|-39.088|||Mixed Models Analysis|One-sided p-values (adjusted for multiplicity) was derived from the MMRM model.||Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-39.088|-56.067|<0.001
72528583|NCT02055976|144587579|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-63.346|STANDARD_ERROR_OF_MEAN|4.244|<|0.001|TWO_SIDED|95.0|-71.776|-54.915|||Mixed Models Analysis|One-sided p-values (adjusted for multiplicity) was derived from the MMRM model.||Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-54.915|-71.776|<0.001
72528584|NCT02055976|144587579|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-66.691|STANDARD_ERROR_OF_MEAN|4.226|<|0.001|TWO_SIDED|95.0|-75.088|-58.295|||Mixed Models Analysis|One-sided p-values (adjusted for multiplicity) was derived from the MMRM model.||Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-58.295|-75.088|<0.001
72528585|NCT02055976|144587581|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-67.254|STANDARD_ERROR_OF_MEAN|4.785|<|0.001|TWO_SIDED|95.0|-76.757|-57.752|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-57.752|-76.757|<0.001
72528586|NCT02055976|144587581|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-87.122|STANDARD_ERROR_OF_MEAN|4.959|<|0.001|TWO_SIDED|95.0|-96.969|-77.275|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-77.275|-96.969|<0.001
72528587|NCT02055976|144587581|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-93.327|STANDARD_ERROR_OF_MEAN|4.949|<|0.001|TWO_SIDED|95.0|-103.153|-83.501|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-83.501|-103.153|<0.001
72528588|NCT02055976|144587581|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-71.724|STANDARD_ERROR_OF_MEAN|6.243|<|0.001|TWO_SIDED|95.0|-84.128|-59.321|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-59.321|-84.128|<0.001
72528589|NCT02055976|144587581|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-96.206|STANDARD_ERROR_OF_MEAN|6.209|<|0.001|TWO_SIDED|95.0|-108.541|-83.872|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-83.872|-108.541|<0.001
72528590|NCT02055976|144587581|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-98.533|STANDARD_ERROR_OF_MEAN|6.145|<|0.001|TWO_SIDED|95.0|-110.743|-86.323|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-86.323|-110.743|<0.001
72528591|NCT02055976|144587581|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-56.225|STANDARD_ERROR_OF_MEAN|4.736|<|0.001|TWO_SIDED|95.0|-65.63|-46.819|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-46.819|-65.630|<0.001
72528592|NCT02055976|144587581|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-73.813|STANDARD_ERROR_OF_MEAN|4.881|<|0.001|TWO_SIDED|95.0|-83.507|-64.119|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-64.119|-83.507|<0.001
72542601|NCT03840811|144615084|OTHER|||||||0.23|||||||Sign test|||To assess whether the fitness of a given mutant is different than that of wild-type, the ratio of colony-forming units of the mutant strain was compared to those of the WT strain at the time of treatment and in the inoculum using a Wilcoxon Signed-Rank Test with a significance level of 0.025. CIs of participants in Mixed FA1090 + FA7537 group were compared to mean = 1.||||0.230
72625483|NCT00583219|144780289|SUPERIORITY_OR_OTHER|||||||0.003|||||||Wilcoxon (Mann-Whitney)|||P value change from baseline to 1 month||||0.003
72528593|NCT02055976|144587581|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-81.239|STANDARD_ERROR_OF_MEAN|4.885|<|0.001|TWO_SIDED|95.0|-90.939|-71.538|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-71.538|-90.939|<0.001
72528594|NCT02055976|144587581|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-72.573|STANDARD_ERROR_OF_MEAN|5.983|<|0.001|TWO_SIDED|95.0|-84.461|-60.684|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-60.684|-84.461|<0.001
72528595|NCT02055976|144587581|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-96.222|STANDARD_ERROR_OF_MEAN|5.948|<|0.001|TWO_SIDED|95.0|-108.039|-84.405|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-84.405|-108.039|<0.001
72528596|NCT02055976|144587581|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-102.184|STANDARD_ERROR_OF_MEAN|5.919|<|0.001|TWO_SIDED|95.0|-113.945|-90.424|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113:Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-90.424|-113.945|<0.001
72528597|NCT02055976|144587583|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-69.537|STANDARD_ERROR_OF_MEAN|5.721|<|0.001|TWO_SIDED|95.0|-80.9|-58.175|||Mixed Models Analysis|One-sided p-value (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-58.175|-80.900|<0.001
72528598|NCT02055976|144587583|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-86.446|STANDARD_ERROR_OF_MEAN|5.855|<|0.001|TWO_SIDED|95.0|-98.074|-74.818|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-74.818|-98.074|<0.001
72528599|NCT02055976|144587583|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-98.273|STANDARD_ERROR_OF_MEAN|5.898|<|0.001|TWO_SIDED|95.0|-109.983|-86.563|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-86.563|-109.983|<0.001
72528600|NCT02055976|144587583|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-71.435|STANDARD_ERROR_OF_MEAN|7.209|<|0.001|TWO_SIDED|95.0|-85.757|-57.112|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-57.112|-85.757|<0.001
72528601|NCT02055976|144587583|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-94.959|STANDARD_ERROR_OF_MEAN|7.236|<|0.001|TWO_SIDED|95.0|-109.333|-80.585|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-80.585|-109.333|<0.001
72528602|NCT02055976|144587583|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-98.519|STANDARD_ERROR_OF_MEAN|7.15|<|0.001|TWO_SIDED|95.0|-112.727|-84.311|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-84.311|-112.727|<0.001
72528603|NCT02055976|144587583|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-55.191|STANDARD_ERROR_OF_MEAN|5.741|<|0.001|TWO_SIDED|95.0|-66.592|-43.791|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-43.791|-66.592|<0.001
72528604|NCT02055976|144587583|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-72.211|STANDARD_ERROR_OF_MEAN|5.848|<|0.001|TWO_SIDED|95.0|-83.825|-60.597|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-60.597|-83.825|<0.001
72528605|NCT02055976|144587583|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-83.065|STANDARD_ERROR_OF_MEAN|5.913|<|0.001|TWO_SIDED|95.0|-94.807|-71.323|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-71.323|-94.807|<0.001
72625484|NCT00583219|144780289|SUPERIORITY_OR_OTHER|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||P value change from baseline to 3 months.||||0.001
72625485|NCT00583219|144780290|SUPERIORITY_OR_OTHER|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||P value change from baseline to one month||||0.001
72625486|NCT00583219|144780290|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||P value change from baseline to 3 months||||<0.001
72625487|NCT00583219|144780291|SUPERIORITY_OR_OTHER|||||||0.007|||||||Wilcoxon (Mann-Whitney)|||P value change from baseline to 1 month.||||0.007
72625488|NCT00583219|144780291|SUPERIORITY_OR_OTHER|||||||0.002|||||||Wilcoxon (Mann-Whitney)|||P value change from baseline to 3 months||||0.002
72528606|NCT02055976|144587583|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-73.879|STANDARD_ERROR_OF_MEAN|6.678|<|0.001|TWO_SIDED|95.0|-87.147|-60.612|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-60.612|-87.147|<0.001
72571652|NCT02912650|144671805|SUPERIORITY_OR_OTHER||LS Mean Difference|0.4||||0.004|TWO_SIDED|95.0|0.13|0.67|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.67|0.13|0.004
72571653|NCT02912650|144671805|SUPERIORITY_OR_OTHER||LS Mean Difference|1.09|||<|0.001|TWO_SIDED|95.0|0.82|1.37|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.37|0.82|<0.001
72528607|NCT02055976|144587583|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-95.428|STANDARD_ERROR_OF_MEAN|6.697||0.001|TWO_SIDED|95.0|-108.732|-82.124|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-82.124|-108.732|0.001
72528608|NCT02055976|144587583|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-104.859|STANDARD_ERROR_OF_MEAN|6.654|<|0.001|TWO_SIDED|95.0|-118.079|-91.639|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-91.639|-118.079|<0.001
72528609|NCT02055976|144587584|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-31.642|STANDARD_ERROR_OF_MEAN|2.717|<|0.001|TWO_SIDED|95.0|-37.039|-26.246|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-26.246|-37.039|<0.001
72528610|NCT02055976|144587584|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-39.88|STANDARD_ERROR_OF_MEAN|2.781|<|0.001|TWO_SIDED|95.0|-45.403|-34.358|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-34.358|-45.403|<0.001
72528611|NCT02055976|144587584|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-45.889|STANDARD_ERROR_OF_MEAN|2.8|<|0.001|TWO_SIDED|95.0|-51.45|-40.329|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-40.329|-51.450|<0.001
72528612|NCT02055976|144587584|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-30.137|STANDARD_ERROR_OF_MEAN|3.006|<|0.001|TWO_SIDED|95.0|-36.11|-24.164|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-24.164|-36.110|<0.001
72528613|NCT02055976|144587584|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-39.525|STANDARD_ERROR_OF_MEAN|3.018|<|0.001|TWO_SIDED|95.0|-45.52|-33.531|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-33.531|-45.520|<0.001
72528614|NCT02055976|144587584|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-41.372|STANDARD_ERROR_OF_MEAN|2.983|<|0.001|TWO_SIDED|95.0|-47.299|-35.445|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-35.445|-47.299|<0.001
72542602|NCT03840811|144615085|OTHER||Risk Difference (RD)|-0.14||||0.54|TWO_SIDED|95.0|-0.58|0.34||One-sided Fisher's Exact Test with alpha=0.025|Fisher Exact|||||0.34|-0.58|0.54
72542603|NCT01625845|144615091|SUPERIORITY_OR_OTHER|||||||0.474|TWO_SIDED|95.0|||||ANCOVA|||||||.474
72542604|NCT01625845|144615092|SUPERIORITY_OR_OTHER|||||||0.068|TWO_SIDED|95.0|||||ANCOVA|||||||.068
72542605|NCT01625845|144615093|SUPERIORITY_OR_OTHER|||||||0.296|TWO_SIDED|95.0|||||ANCOVA|||||||.296
72542606|NCT01625845|144615094|SUPERIORITY_OR_OTHER|||||||0.203|TWO_SIDED|95.0|||||ANCOVA|||||||.203
72542607|NCT01625845|144615095|SUPERIORITY_OR_OTHER|||||||0.906|TWO_SIDED||||||ANCOVA|||||||.906
72542608|NCT01625845|144615096|SUPERIORITY_OR_OTHER|||||||0.869|TWO_SIDED|95.0|||||ANCOVA|||||||.869
72542609|NCT01625845|144615097|SUPERIORITY_OR_OTHER|||||||0.026|TWO_SIDED|95.0|||||ANCOVA|||||||.026
72542610|NCT01078623|144615115|SUPERIORITY_OR_OTHER||Least squares mean difference|0.221|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001|TWO_SIDED|95.0|0.174|0.268|||Mixed Models Analysis|Treatment and period as fixed effects, subject as random effect, and baseline values at each period as a covariate||||0.268|0.174|<0.0001
72542611|NCT01078623|144615115|SUPERIORITY_OR_OTHER||Least squares mean difference|0.234|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001|TWO_SIDED|95.0|0.186|0.281|||Mixed Models Analysis|Treatment and period as fixed effects, subject as random effect, and baseline values at each period as a covariate||||0.281|0.186|<0.0001
72571654|NCT02912650|144671805|SUPERIORITY_OR_OTHER||LS Mean Difference|1.66|||<|0.001|TWO_SIDED|95.0|1.27|2.04|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||2.04|1.27|<0.001
72542612|NCT02186808|144615127|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
72571655|NCT02912650|144671805|SUPERIORITY_OR_OTHER||LS Mean Difference|0.97|||<|0.001|TWO_SIDED|95.0|0.58|1.36|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.36|0.58|<0.001
72528615|NCT02055976|144587584|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-25.374|STANDARD_ERROR_OF_MEAN|2.69|<|0.001|TWO_SIDED|95.0|-30.717|-20.032|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-20.032|-30.717|<0.001
72528616|NCT02055976|144587584|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-33.49|STANDARD_ERROR_OF_MEAN|2.741|<|0.001|TWO_SIDED|95.0|-38.934|-28.047|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-28.047|-38.934|<0.001
72528617|NCT02055976|144587584|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-38.76|STANDARD_ERROR_OF_MEAN|2.77|<|0.001|TWO_SIDED|95.0|-44.262|-33.258|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-33.258|-44.262|<0.001
72528618|NCT02055976|144587584|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-30.847|STANDARD_ERROR_OF_MEAN|2.879|<|0.001|TWO_SIDED|95.0|-36.568|-25.127|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-25.127|-36.568|<0.001
72528619|NCT02055976|144587584|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-40.019|STANDARD_ERROR_OF_MEAN|2.887|<|0.001|TWO_SIDED|95.0|-45.754|-34.285|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-34.285|-45.754|<0.001
72528620|NCT02055976|144587584|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-43.947|STANDARD_ERROR_OF_MEAN|2.869|<|0.001|TWO_SIDED|95.0|-49.647|-38.247|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113:Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-38.247|-49.647|<0.001
72528621|NCT02055976|144587586|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-41.118|STANDARD_ERROR_OF_MEAN|3.344|<|0.001|TWO_SIDED|95.0|-47.76|-34.476|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-34.476|-47.760|<0.001
72528622|NCT02055976|144587586|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-54.787|STANDARD_ERROR_OF_MEAN|3.402|<|0.001|TWO_SIDED|95.0|-61.543|-48.032|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-48.032|-61.543|<0.001
72528623|NCT02055976|144587586|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-60.549|STANDARD_ERROR_OF_MEAN|3.453|<|0.001|TWO_SIDED|95.0|-67.403|-53.694|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-53.694|-67.403|<0.001
72528624|NCT02055976|144587586|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-36.589|STANDARD_ERROR_OF_MEAN|3.73|<|0.001|TWO_SIDED|95.0|-43.999|-29.178|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-29.178|-43.999|<0.001
72528625|NCT02055976|144587586|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-54.683|STANDARD_ERROR_OF_MEAN|3.734|<|0.001|TWO_SIDED|95.0|-62.102|-47.265|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-47.265|-62.102|<0.001
72571656|NCT02912650|144671805|SUPERIORITY_OR_OTHER||LS Mean Difference|0.69|||<|0.001|TWO_SIDED|95.0|0.42|0.96|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.96|0.42|<0.001
72571657|NCT02912650|144671805|SUPERIORITY_OR_OTHER||LS Mean Difference|2.0|||<|0.001|TWO_SIDED|95.0|1.6|2.4|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||2.40|1.60|<0.001
72571658|NCT02912650|144671805|SUPERIORITY_OR_OTHER||LS Mean Difference|0.44||||0.002|TWO_SIDED|95.0|0.16|0.72|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.72|0.16|0.002
72571659|NCT02912650|144671805|SUPERIORITY_OR_OTHER||LS Mean Difference|1.16|||<|0.001|TWO_SIDED|95.0|0.88|1.44|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.44|0.88|<0.001
72571660|NCT02912650|144671805|SUPERIORITY_OR_OTHER||LS Mean Difference|1.56|||<|0.001|TWO_SIDED|95.0|1.16|1.96|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.96|1.16|<0.001
72369365|NCT00806819|144248655|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.93||||0.4264|TWO_SIDED|95.0|0.77|1.12|||Regression, Cox||HR below 1 favors nintedanib|Analysis evaluating the time to deterioration of dyspnoea. HR, CI and p-value obtained from the prop. hazards model stratified by baseline ECOG PS (0 vs \>=1), tumour histology (adenocarcinoma vs. non-adenocarcinoma), brain metastases at baseline (yes vs no) and prior treatment with bevacizumab (yes vs no).||1.12|0.77|0.4264
72528626|NCT02055976|144587586|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-56.517|STANDARD_ERROR_OF_MEAN|3.688|<|0.001|TWO_SIDED|95.0|-63.845|-49.189|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-49.189|-63.845|<0.001
72528627|NCT02055976|144587586|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-33.262|STANDARD_ERROR_OF_MEAN|3.196|<|0.001|TWO_SIDED|95.0|-39.608|-26.915|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-26.915|-39.608|<0.001
72528628|NCT02055976|144587586|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-45.956|STANDARD_ERROR_OF_MEAN|3.239|<|0.001|TWO_SIDED|95.0|-52.388|-39.523|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-39.523|-52.388|<0.001
72528629|NCT02055976|144587586|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-51.5|STANDARD_ERROR_OF_MEAN|3.305|<|0.001|TWO_SIDED|95.0|-58.063|-44.937|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-44.937|-58.063|<0.001
72528630|NCT02055976|144587586|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-40.474|STANDARD_ERROR_OF_MEAN|3.547|<|0.001|TWO_SIDED|95.0|-47.523|-33.426|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-33.426|-47.523|<0.001
72528631|NCT02055976|144587586|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-54.634|STANDARD_ERROR_OF_MEAN|3.549|<|0.001|TWO_SIDED|95.0|-61.685|-47.583|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-47.583|-61.685|<0.001
72528632|NCT02055976|144587586|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-59.608|STANDARD_ERROR_OF_MEAN|3.52|<|0.001|TWO_SIDED|95.0|-66.602|-52.614|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113:Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-52.614|-66.602|<0.001
72528633|NCT02055976|144587587|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-43.265|STANDARD_ERROR_OF_MEAN|3.566|<|0.001|TWO_SIDED|95.0|-50.347|-36.183|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-36.183|-50.347|<0.001
72528634|NCT02055976|144587587|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-57.962|STANDARD_ERROR_OF_MEAN|3.628|<|0.001|TWO_SIDED|95.0|-65.167|-50.758|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-50.758|-65.167|<0.001
72528635|NCT02055976|144587587|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-64.729|STANDARD_ERROR_OF_MEAN|3.682|<|0.001|TWO_SIDED|95.0|-72.039|-57.419|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-57.419|-72.039|<0.001
72571661|NCT02912650|144671805|SUPERIORITY_OR_OTHER||LS Mean Difference|0.84|||<|0.001|TWO_SIDED|95.0|0.44|1.24|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.24|0.44|<0.001
72528636|NCT02055976|144587587|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-36.428|STANDARD_ERROR_OF_MEAN|3.535|<|0.001|TWO_SIDED|95.0|-43.451|-29.405|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-29.405|-43.451|<0.001
72571662|NCT02912650|144671805|SUPERIORITY_OR_OTHER||LS Mean Difference|0.72|||<|0.001|TWO_SIDED|95.0|0.44|1.0|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.00|0.44|<0.001
72571663|NCT02912650|144671805|SUPERIORITY_OR_OTHER||LS Mean Difference|1.91|||<|0.001|TWO_SIDED|95.0|1.5|2.31|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||2.31|1.50|<0.001
72571664|NCT02912650|144671805|SUPERIORITY_OR_OTHER||LS Mean Difference|0.46||||0.001|TWO_SIDED|95.0|0.18|0.74|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.74|0.18|0.001
72571665|NCT02912650|144671805|SUPERIORITY_OR_OTHER||LS Mean Difference|1.14|||<|0.001|TWO_SIDED|95.0|0.85|1.43|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.43|0.85|<0.001
72571666|NCT02912650|144671805|SUPERIORITY_OR_OTHER||LS Mean Difference|1.45|||<|0.001|TWO_SIDED|95.0|1.04|1.85|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.85|1.04|<0.001
72571667|NCT02912650|144671805|SUPERIORITY_OR_OTHER||LS Mean Difference|0.77|||<|0.001|TWO_SIDED|95.0|0.36|1.17|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.17|0.36|<0.001
72407438|NCT01513291|144323432|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.0||||0.9737|TWO_SIDED|95.0|0.7|1.5|||Generalized linear mixed effects model||Odds ratio is for MK-6096 / Placebo. The generalized linear mixed effects model included terms for treatment, time, treatment-by-time interaction, monthly migraine days during the Treatment Period 1 (≤8, \>8) as covariates.|||1.5|0.7|0.97370
72528637|NCT02055976|144587587|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-53.296|STANDARD_ERROR_OF_MEAN|3.538|<|0.001|TWO_SIDED|95.0|-60.325|-46.267|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-46.267|-60.325|<0.001
72528638|NCT02055976|144587587|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-55.489|STANDARD_ERROR_OF_MEAN|3.496|<|0.001|TWO_SIDED|95.0|-62.436|-48.542|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-48.542|-62.436|<0.001
72528639|NCT02055976|144587587|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-35.288|STANDARD_ERROR_OF_MEAN|3.41|<|0.001|TWO_SIDED|95.0|-42.059|-28.516|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-28.516|-42.059|<0.001
72528640|NCT02055976|144587587|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-48.845|STANDARD_ERROR_OF_MEAN|3.456|<|0.001|TWO_SIDED|95.0|-55.709|-41.982|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-41.982|-55.709|<0.001
72528641|NCT02055976|144587587|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-55.114|STANDARD_ERROR_OF_MEAN|3.526|<|0.001|TWO_SIDED|95.0|-62.116|-48.112|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-48.112|-62.116|<0.001
72528642|NCT02055976|144587587|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-40.045|STANDARD_ERROR_OF_MEAN|3.56|<|0.001|TWO_SIDED|95.0|-47.118|-32.971|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-32.971|-47.118|<0.001
72528643|NCT02055976|144587587|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-53.81|STANDARD_ERROR_OF_MEAN|3.56|<|0.001|TWO_SIDED|95.0|-60.883|-46.737|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-46.737|-60.883|<0.001
72528644|NCT02055976|144587587|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-58.62|STANDARD_ERROR_OF_MEAN|3.533|<|0.001|TWO_SIDED|95.0|-65.64|-51.6|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113:Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-51.600|-65.640|<0.001
72528645|NCT02055976|144587589|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|8.896|STANDARD_ERROR_OF_MEAN|2.643|<|0.001|TWO_SIDED|95.0|3.646|14.145|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||14.145|3.646|<0.001
72571668|NCT02912650|144671805|SUPERIORITY_OR_OTHER||LS Mean Difference|0.68|||<|0.001|TWO_SIDED|95.0|0.39|0.97|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.97|0.39|<0.001
72571669|NCT02912650|144671805|SUPERIORITY_OR_OTHER||LS Mean Difference|1.55|||<|0.001|TWO_SIDED|95.0|1.13|1.98|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.98|1.13|<0.001
72407439|NCT03732638|144323433|SUPERIORITY||Mean Difference (Final Values)|-0.8||||0.0099|TWO_SIDED|95.0|-1.46|-0.2|||Mixed Models Analysis|||||-0.20|-1.46|0.0099
72528646|NCT02055976|144587589|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|15.429|STANDARD_ERROR_OF_MEAN|2.662|<|0.001|TWO_SIDED|95.0|10.141|20.717|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||20.717|10.141|<0.001
72571670|NCT02912650|144671805|SUPERIORITY_OR_OTHER||LS Mean Difference|0.36||||0.017|TWO_SIDED|95.0|0.06|0.65|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.65|0.06|0.017
72571671|NCT02912650|144671805|SUPERIORITY_OR_OTHER||LS Mean Difference|1.07|||<|0.001|TWO_SIDED|95.0|0.77|1.37|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.37|0.77|<0.001
72625489|NCT02090764|144780292|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|||||||Chi-squared|||The treatment comparison was done using only the outcomes of Clinical success and Clinical failure. The p value of the chi square test (without continuity correction) was provided. The analysis was performed to test the superiority of ozenoxacin versus placebo.||||0.001
72625490|NCT02384421|144780293|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
72625491|NCT02384421|144780294|SUPERIORITY|||||||0.0064|||||||t-test, 2 sided|||||||0.0064
72407440|NCT03732638|144323434|SUPERIORITY||Risk Difference (RD)|7.6||||0.0438|TWO_SIDED|95.0|0.2|14.9|||Cochran-Mantel-Haenszel|||||14.9|0.2|0.0438
72528647|NCT02055976|144587589|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|12.321|STANDARD_ERROR_OF_MEAN|2.7|<|0.001|TWO_SIDED|95.0|6.959|17.683|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||17.683|6.959|<0.001
72528648|NCT02055976|144587589|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|6.804|STANDARD_ERROR_OF_MEAN|3.041||0.014|TWO_SIDED|95.0|0.761|12.847|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||12.847|0.761|0.014
72528649|NCT02055976|144587589|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|10.565|STANDARD_ERROR_OF_MEAN|3.023|<|0.001|TWO_SIDED|95.0|4.556|16.573|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||16.573|4.556|<0.001
72528650|NCT02055976|144587589|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|12.895|STANDARD_ERROR_OF_MEAN|2.969|<|0.001|TWO_SIDED|95.0|6.993|18.796|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||18.796|6.993|<0.001
72528651|NCT02055976|144587589|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|8.644|STANDARD_ERROR_OF_MEAN|3.266||0.005|TWO_SIDED|95.0|2.157|15.13|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||15.130|2.157|0.005
72528652|NCT02055976|144587589|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|14.708|STANDARD_ERROR_OF_MEAN|3.272|<|0.001|TWO_SIDED|95.0|8.208|21.208|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||21.208|8.208|<0.001
72528653|NCT02055976|144587589|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|11.168|STANDARD_ERROR_OF_MEAN|3.317|<|0.001|TWO_SIDED|95.0|4.58|17.757|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||17.757|4.580|<0.001
72528654|NCT02055976|144587589|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|8.132|STANDARD_ERROR_OF_MEAN|2.609||0.001|TWO_SIDED|95.0|2.947|13.316|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||13.316|2.947|0.001
72528655|NCT02055976|144587589|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|10.23|STANDARD_ERROR_OF_MEAN|2.592|<|0.001|TWO_SIDED|95.0|5.079|15.381|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||15.381|5.079|<0.001
72528656|NCT02055976|144587589|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|5.767|STANDARD_ERROR_OF_MEAN|2.565||0.014|TWO_SIDED|95.0|0.67|10.864|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113:Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||10.864|0.670|0.014
72528657|NCT02055976|144587590|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|6.079|STANDARD_ERROR_OF_MEAN|1.905|<|0.001|TWO_SIDED|95.0|2.296|9.863|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||9.863|2.296|<0.001
72528658|NCT02055976|144587590|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|10.786|STANDARD_ERROR_OF_MEAN|1.918|<|0.001|TWO_SIDED|95.0|6.976|14.597|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||14.597|6.976|<0.001
72528659|NCT02055976|144587590|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|9.069|STANDARD_ERROR_OF_MEAN|1.945|<|0.001|TWO_SIDED|95.0|5.206|12.932|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||12.932|5.206|<0.001
72528660|NCT02055976|144587590|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|4.859|STANDARD_ERROR_OF_MEAN|2.173||0.014|TWO_SIDED|95.0|0.541|9.178|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||9.178|0.541|0.014
72571672|NCT02912650|144671805|SUPERIORITY_OR_OTHER||LS Mean Difference|1.2|||<|0.001|TWO_SIDED|95.0|0.78|1.62|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.62|0.78|<0.001
72407441|NCT03732638|144323435|SUPERIORITY||Mean Difference (Net)|-0.8||||0.0017|TWO_SIDED|95.0|-1.34|-0.31|||Mixed Models Analysis|||||-0.31|-1.34|0.0017
72407442|NCT03732638|144323436|SUPERIORITY||Mean Difference (Net)|-0.2||||0.3868|TWO_SIDED|95.0|-0.8|0.31||P-value ≥ 0.05; therefore, all secondary endpoints listed after this endpoint in the hierarchy were not tested.|Mixed Models Analysis|||||0.31|-0.80|0.3868
72407443|NCT01462357|144323459|NON_INFERIORITY|Non-inferiority with respect to seroconversion was shown if, one month after the last dose, for both anti-HPV-16 and anti-HPV-18 antibodies, the upper limit of the 95% confidence interval (CI) for the difference (Gardasil 2 dose Group minus Cervarix 2 dose Group) was below 5%.|Difference in SCR|0.0|||||TWO_SIDED|95.0|-1.16|1.15||||||Immune response to anti-HPV-16 in terms of seroconversion rates (SCR): To evaluate sequentially if the immunogenicity (as determined by ELISA) of Cervarix vaccine administered according to a 2-dose schedule at 0, 6 months is non-inferior to that of Gardasil vaccine administered according to a 2-dose schedule at 0, 6 months, 1 month after the last dose (Month 7), in initially seronegative subjects.||1.15|-1.16|
72407444|NCT01462357|144323459|NON_INFERIORITY|Non-inferiority with respect to seroconversion was shown if, one month after the last dose, for both anti-HPV-16 and anti-HPV-18 antibodies, the upper limit of the 95% confidence interval (CI) for the difference (Gardasil 2 dose Group minus Cervarix 2 dose Group) was below 5%.|Difference in SCR|0.0|||||TWO_SIDED|95.0|-1.15|1.14||||||Immune response to anti-HPV-18 in terms of SCR: To evaluate sequentially if the immunogenicity (as determined by ELISA) of Cervarix vaccine administered according to a 2-dose schedule at 0, 6 months is non-inferior to that of Gardasil vaccine administered according to a 2-dose schedule at 0, 6 months, 1 month after the last dose (Month 7), in initially seronegative subjects.||1.14|-1.15|
72407445|NCT01462357|144323460|NON_INFERIORITY|Non-inferiority with respect to GMT was shown if, one month after the last dose, for both anti-HPV-16 and anti-HPV-18 antibodies, the upper limit of the 95% CI for the GMT ratio (Gardasil 2 dose Group divided by Cervarix 2 dose Group) was below 2.|GMT ratio|0.61|||||TWO_SIDED|95.0|0.54|0.69|||ANOVA|||Immune response to anti-HPV-16 in terms of Geometric Mean Titers (GMT): To evaluate sequentially if the immunogenicity (as determined by ELISA) of Cervarix vaccine administered according to a 2-dose schedule at 0, 6 months is non-inferior to that of Gardasil vaccine administered according to a 2-dose schedule at 0, 6 months, 1 month after the last dose (Month 7), in initially seronegative subjects.||0.69|0.54|
72407446|NCT01462357|144323460|NON_INFERIORITY|Non-inferiority with respect to GMT was shown if, one month after the last dose, for both anti-HPV-16 and anti-HPV-18 antibodies, the upper limit of the 95% confidence interval (CI) for the GMT ratio (Gardasil 2 dose Group divided by Cervarix 2 dose Group) was below 2.|GMT ratio|0.23|||||TWO_SIDED|95.0|0.2|0.26|||ANOVA|||Immune response to anti-HPV-18 in terms of GMT: To evaluate sequentially if the immunogenicity (as determined by ELISA) of Cervarix vaccine administered according to a 2-dose schedule at 0, 6 months is non-inferior to that of Gardasil vaccine administered according to a 2-dose schedule at 0, 6 months, 1 month after the last dose (Month 7), in initially seronegative subjects.||0.26|0.20|
72407447|NCT01462357|144323461|SUPERIORITY|Superiority was shown if the lower limit of the 95% CI for the ratio of GMTs (Cervarix 2 dose Group divided by Gardasil 2 dose Group) was above 1 for anti-HPV-18 antibodies.|GMT ratio|4.52||||0.0001|TWO_SIDED|95.0|3.97|5.13|||ANOVA|||Anti-HPV-18 immune response: To evaluate sequentially if the immunogenicity (as determined by ELISA) of Cervarix vaccine administered according to a 2-dose schedule at 0, 6 months is superior to that of Gardasil vaccine administered according to a 2-dose schedule at 0, 6 months, in 9-14 year-old females, 1 month after the last dose (Month 7) regardless of serostatus.||5.13|3.97|0.0001
72528661|NCT02055976|144587590|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|7.331|STANDARD_ERROR_OF_MEAN|2.161|<|0.001|TWO_SIDED|95.0|3.037|11.624|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||11.624|3.037|<0.001
72528662|NCT02055976|144587590|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|9.075|STANDARD_ERROR_OF_MEAN|2.122|<|0.001|TWO_SIDED|95.0|4.856|13.293|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||13.293|4.856|<0.001
72407448|NCT01462357|144323461|SUPERIORITY|Superiority was shown if the lower limit of the 95% CI for the ratio of GMTs (Cervarix 2 dose Group divided by Gardasil 2 dose Group) was above 1 for anti-HPV-16 antibodies.|GMT ratio|1.69||||0.0001|TWO_SIDED|95.0|1.49|1.91|||ANOVA|||Anti-HPV-16 immune response: To evaluate sequentially if the immunogenicity (as determined by ELISA) of Cervarix vaccine administered according to a 2-dose schedule at 0, 6 months is superior to that of Gardasil vaccine administered according to a 2-dose schedule at 0, 6 months, in 9-14 year-old females, 1 month after the last dose (Month 7) regardless of serostatus.||1.91|1.49|0.0001
72528663|NCT02055976|144587590|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|5.936|STANDARD_ERROR_OF_MEAN|2.266||0.005|TWO_SIDED|95.0|1.435|10.437|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||10.437|1.435|0.005
72528664|NCT02055976|144587590|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|10.213|STANDARD_ERROR_OF_MEAN|2.271|<|0.001|TWO_SIDED|95.0|5.702|14.724|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||14.724|5.702|<0.001
72407449|NCT03385239|144323494|SUPERIORITY||Mean Difference in % CFB|-27.0||||0.0042|TWO_SIDED|95.0|-41.0|-10.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in least square mean (LSM) of log (Primary Analysis Time Point/Baseline) was estimated.|||-10|-41|0.0042
72528665|NCT02055976|144587590|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|8.056|STANDARD_ERROR_OF_MEAN|2.302|<|0.001|TWO_SIDED|95.0|3.484|12.629|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||12.629|3.484|<0.001
72407450|NCT03385239|144323494|SUPERIORITY||Mean Difference in % CFB|-58.0|||<|0.0001|TWO_SIDED|95.0|-66.0|-48.0|||ANCOVA||Mean difference in % CFB based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|||-48|-66|<0.0001
72528666|NCT02055976|144587590|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|5.846|STANDARD_ERROR_OF_MEAN|1.778|<|0.001|TWO_SIDED|95.0|2.312|9.38|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||9.380|2.312|<0.001
72528667|NCT02055976|144587590|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|6.91|STANDARD_ERROR_OF_MEAN|1.766|<|0.001|TWO_SIDED|95.0|3.4|10.421|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||10.421|3.400|<0.001
72528668|NCT02055976|144587590|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|4.168|STANDARD_ERROR_OF_MEAN|1.748||0.01|TWO_SIDED|95.0|0.693|7.642|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113:Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||7.642|0.693|0.010
72528669|NCT02055976|144587592|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.7208|STANDARD_ERROR_OF_MEAN|0.6289||0.127|TWO_SIDED|95.0|-0.5283|1.97|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||1.9700|-0.5283|0.127
72528670|NCT02055976|144587592|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|1.0574|STANDARD_ERROR_OF_MEAN|0.6461||0.053|TWO_SIDED|95.0|-0.2259|2.3406|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||2.3406|-0.2259|0.053
72528671|NCT02055976|144587592|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.2445|STANDARD_ERROR_OF_MEAN|0.6511||0.354|TWO_SIDED|95.0|-1.0486|1.5375|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||1.5375|-1.0486|0.354
72528672|NCT02055976|144587592|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.8055|STANDARD_ERROR_OF_MEAN|0.8615||0.176|TWO_SIDED|95.0|-0.9066|2.5177|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||2.5177|-0.9066|0.176
72528673|NCT02055976|144587592|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|2.0071|STANDARD_ERROR_OF_MEAN|0.8641||0.011|TWO_SIDED|95.0|0.2899|3.7242|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||3.7242|0.2899|0.011
72528674|NCT02055976|144587592|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|1.7116|STANDARD_ERROR_OF_MEAN|0.852||0.024|TWO_SIDED|95.0|0.0184|3.4049|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||3.4049|0.0184|0.024
72528675|NCT02055976|144587592|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.8585|STANDARD_ERROR_OF_MEAN|0.7844||0.138|TWO_SIDED|95.0|-0.6992|2.4163|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||2.4163|-0.6992|0.138
72528676|NCT02055976|144587592|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.8807|STANDARD_ERROR_OF_MEAN|0.799||0.137|TWO_SIDED|95.0|-0.7064|2.4678|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||2.4678|-0.7064|0.137
72571673|NCT02912650|144671805|SUPERIORITY_OR_OTHER||LS Mean Difference|0.48||||0.026|TWO_SIDED|95.0|0.06|0.91|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.91|0.06|0.026
72625492|NCT02384421|144780295|SUPERIORITY|||||||0.014|||||||t-test, 2 sided|||||||0.014
72625493|NCT02384421|144780296|SUPERIORITY|||||||0.25|||||||Wilcoxon Signed-Rank Test|||||||0.25
72407451|NCT03385239|144323494|SUPERIORITY||Mean Difference in % CFB|-63.0|||<|0.0001|TWO_SIDED|95.0|-70.0|-54.0|||ANCOVA||Mean difference in % CFB based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|||-54|-70|<0.0001
72407452|NCT03385239|144323494|SUPERIORITY||Mean Difference in % CFB|-62.0|||<|0.0001|TWO_SIDED|95.0|-69.0|-53.0|||ANCOVA||Mean difference in % CFB based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|||-53|-69|<0.0001
72407453|NCT03385239|144323496|SUPERIORITY||Mean Difference in % CFB|-30.0||||0.0123|TWO_SIDED|95.0|-47.0|-8.0|||ANCOVA||Mean difference in % CFB based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|ApoC III||-8|-47|0.0123
72528677|NCT02055976|144587592|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.2624|STANDARD_ERROR_OF_MEAN|0.8053||0.373|TWO_SIDED|95.0|-1.337|1.8618|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||1.8618|-1.3370|0.373
72528678|NCT02055976|144587592|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.3239|STANDARD_ERROR_OF_MEAN|0.7472||0.333|TWO_SIDED|95.0|-1.1611|1.8089|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||1.8089|-1.1611|0.333
72528679|NCT02055976|144587592|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|1.9322|STANDARD_ERROR_OF_MEAN|0.7488||0.006|TWO_SIDED|95.0|0.4441|3.4203|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||3.4203|0.4441|0.006
72528680|NCT02055976|144587592|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.834|STANDARD_ERROR_OF_MEAN|0.7442||0.133|TWO_SIDED|95.0|-0.6451|2.313|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113:Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||2.3130|-0.6451|0.133
72571674|NCT02912650|144671805|SUPERIORITY_OR_OTHER||LS Mean Difference|0.72|||<|0.001|TWO_SIDED|95.0|0.42|1.01|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.01|0.42|<0.001
72571675|NCT02912650|144671805|SUPERIORITY_OR_OTHER||LS Mean Difference|1.27|||<|0.001|TWO_SIDED|95.0|0.84|1.69|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.69|0.84|<0.001
72571676|NCT02912650|144671805|SUPERIORITY_OR_OTHER||LS Mean Difference|0.36||||0.017|TWO_SIDED|95.0|0.07|0.66|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.66|0.07|0.017
72571677|NCT02912650|144671805|SUPERIORITY_OR_OTHER||LS Mean Difference|0.9|||<|0.001|TWO_SIDED|95.0|0.6|1.2|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.20|0.60|<0.001
72571678|NCT02912650|144671805|SUPERIORITY_OR_OTHER||LS Mean Difference|0.9|||<|0.001|TWO_SIDED|95.0|0.48|1.33|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.33|0.48|<0.001
72571679|NCT02912650|144671805|SUPERIORITY_OR_OTHER||LS Mean Difference|0.37||||0.089|TWO_SIDED|95.0|-0.06|0.8|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.80|-0.06|0.089
72571680|NCT02912650|144671805|SUPERIORITY_OR_OTHER||LS Mean Difference|0.53|||<|0.001|TWO_SIDED|95.0|0.24|0.83|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.83|0.24|<0.001
72369166|NCT04672655|144248419|OTHER|||||||0.4811||||||The a priori threshold for statistical significance was \< 0.05.|linear mixed effects models|||A linear mixed effects model (LMM) was used to examine outcomes measured at 3, 6, and 12 months. An unstructured covariance matrix was specified to model within-subject correlations across repeated measurements. To address missing data, the LMM utilized a likelihood-based approach under the missing-at-random (MAR) assumption, which incorporates all available data, thereby minimizing bias from incomplete follow-up measurements.||||0.4811
72571681|NCT02912650|144671805|SUPERIORITY_OR_OTHER||LS Mean Difference|1.02|||<|0.001|TWO_SIDED|95.0|0.6|1.44|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.44|0.60|<0.001
72571682|NCT02912650|144671805|SUPERIORITY_OR_OTHER||LS Mean Difference|0.35||||0.018|TWO_SIDED|95.0|0.06|0.65|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.65|0.06|0.018
72571683|NCT02912650|144671805|SUPERIORITY_OR_OTHER||LS Mean Difference|0.72|||<|0.001|TWO_SIDED|95.0|0.42|1.02|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.02|0.42|<0.001
72571684|NCT02912650|144671805|SUPERIORITY_OR_OTHER||LS Mean Difference|0.67||||0.002|TWO_SIDED|95.0|0.25|1.09|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.09|0.25|0.002
72407454|NCT03385239|144323496|SUPERIORITY||Mean Difference in % CFB|-68.0|||<|0.0001|TWO_SIDED|95.0|-76.0|-58.0|||ANCOVA||Mean difference in % CFB based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|Apo-C III||-58|-76|<0.0001
72407455|NCT03385239|144323496|SUPERIORITY||Mean Difference in % CFB|-74.0|||<|0.0001|TWO_SIDED|95.0|-80.0|-65.0|||ANCOVA||Mean difference in % CFB based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|Apo-C III||-65|-80|<0.0001
72571685|NCT02912650|144671805|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3||||0.163|TWO_SIDED|95.0|-0.12|0.72|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.72|-0.12|0.163
72571686|NCT02912650|144671805|SUPERIORITY_OR_OTHER||LS Mean Difference|0.37||||0.016|TWO_SIDED|95.0|0.07|0.66|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.66|0.07|0.016
72571687|NCT02912650|144671805|SUPERIORITY_OR_OTHER||LS Mean Difference|0.68||||0.002|TWO_SIDED|95.0|0.26|1.1|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.10|0.26|0.002
72571688|NCT02912650|144671805|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1||||0.496|TWO_SIDED|95.0|-0.19|0.4|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.40|-0.19|0.496
72625494|NCT02384421|144780297|SUPERIORITY|||||||0.003|||||||t-test, 2 sided|||||||0.003
72528681|NCT02055976|144587593|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|2.0813|STANDARD_ERROR_OF_MEAN|2.0411||0.155|TWO_SIDED|95.0|-1.973|6.1356|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||6.1356|-1.9730|0.155
72528682|NCT02055976|144587593|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|3.2608|STANDARD_ERROR_OF_MEAN|2.0965||0.062|TWO_SIDED|95.0|-0.9035|7.425|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||7.4250|-0.9035|0.062
72528683|NCT02055976|144587593|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.8224|STANDARD_ERROR_OF_MEAN|2.1126||0.349|TWO_SIDED|95.0|-3.3733|5.0182|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||5.0182|-3.3733|0.349
72528684|NCT02055976|144587593|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|2.3254|STANDARD_ERROR_OF_MEAN|2.7702||0.202|TWO_SIDED|95.0|-3.1801|7.831|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||7.8310|-3.1801|0.202
72528685|NCT02055976|144587593|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|6.1048|STANDARD_ERROR_OF_MEAN|2.7784||0.015|TWO_SIDED|95.0|0.5833|11.6263|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||11.6263|0.5833|0.015
72528686|NCT02055976|144587593|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|5.2393|STANDARD_ERROR_OF_MEAN|2.7396||0.03|TWO_SIDED|95.0|-0.2058|10.6845|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||10.6845|-0.2058|0.030
72528687|NCT02055976|144587593|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|2.1827|STANDARD_ERROR_OF_MEAN|2.4251||0.185|TWO_SIDED|95.0|-2.6334|6.9988|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||6.9988|-2.6334|0.185
72528688|NCT02055976|144587593|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|2.1376|STANDARD_ERROR_OF_MEAN|2.4716||0.195|TWO_SIDED|95.0|-2.7718|7.0469|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||7.0469|-2.7718|0.195
72528689|NCT02055976|144587593|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.3113|STANDARD_ERROR_OF_MEAN|2.4909||0.45|TWO_SIDED|95.0|-4.6358|5.2584|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||5.2584|-4.6358|0.450
72528690|NCT02055976|144587593|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.6078|STANDARD_ERROR_OF_MEAN|2.3322||0.397|TWO_SIDED|95.0|-4.0274|5.2431|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||5.2431|-4.0274|0.397
72528691|NCT02055976|144587593|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|5.7096|STANDARD_ERROR_OF_MEAN|2.3367||0.008|TWO_SIDED|95.0|1.0659|10.3532|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||10.3532|1.0659|0.008
72528692|NCT02055976|144587593|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|2.4558|STANDARD_ERROR_OF_MEAN|2.323||0.147|TWO_SIDED|95.0|-2.1608|7.0724|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113:Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||7.0724|-2.1608|0.147
72528693|NCT02055976|144587595|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-4.9203|STANDARD_ERROR_OF_MEAN|1.3242|<|0.001|TWO_SIDED|95.0|-7.5504|-2.2901|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-2.2901|-7.5504|<0.001
72528694|NCT02055976|144587595|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-7.1983|STANDARD_ERROR_OF_MEAN|1.3462|<|0.001|TWO_SIDED|95.0|-9.8718|-4.5249|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-4.5249|-9.8718|<0.001
72625495|NCT02384421|144780298|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
72625496|NCT04752566|144780355|SUPERIORITY||Hazard Ratio (HR)|0.9||||0.8938|TWO_SIDED|95.0|0.45|1.97||Log Rank Test stratified by randomization strata.|Log Rank||Cox proportional hazard model stratified by randomization strata, with treatment group as the fixed effect. Firth's adjustment was applied if no event was observed in a treatment group.|||1.97|0.45|0.8938
72407456|NCT03385239|144323496|SUPERIORITY||Mean Difference in % CFB|-74.0|||<|0.0001|TWO_SIDED|95.0|-80.0|-66.0|||ANCOVA||Mean difference in % CFB based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|Apo-C III||-66|-80|<0.0001
72407457|NCT03385239|144323496|SUPERIORITY||Mean Difference in % CFB|-3.0||||0.568|TWO_SIDED|95.0|-11.0|7.0|||ANCOVA||Mean difference in % CFB based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|TC||7|-11|0.568
72528695|NCT02055976|144587595|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-7.3118|STANDARD_ERROR_OF_MEAN|1.3505|<|0.001|TWO_SIDED|95.0|-9.9935|-4.6301|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-4.6301|-9.9935|<0.001
72528696|NCT02055976|144587595|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-3.0629|STANDARD_ERROR_OF_MEAN|1.032||0.002|TWO_SIDED|95.0|-5.1132|-1.0125|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-1.0125|-5.1132|0.002
72407458|NCT03385239|144323496|SUPERIORITY||Mean Difference in % CFB|-12.0||||0.008|TWO_SIDED|95.0|-19.0|-3.0|||ANCOVA||Mean difference in % CFB based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|TC||-3|-19|0.008
72407459|NCT03385239|144323496|SUPERIORITY||Mean Difference in % CFB|-3.0||||0.4476|TWO_SIDED|95.0|-12.0|6.0|||ANCOVA||Mean difference in % CFB based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|TC||6|-12|0.4476
72407460|NCT03385239|144323496|SUPERIORITY||Mean Difference in % CFB|-8.0||||0.0606|TWO_SIDED|95.0|-16.0|0.0|||ANCOVA||Mean difference in % CFB based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|TC||0|-16|0.0606
72407461|NCT03385239|144323496|SUPERIORITY||Mean Difference in % CFB|7.0||||0.4509|TWO_SIDED|95.0|-10.0|26.0|||ANCOVA||Mean difference in % CFB based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|LDL-C||26|-10|0.4509
72528697|NCT02055976|144587595|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-3.6209|STANDARD_ERROR_OF_MEAN|1.0367|<|0.001|TWO_SIDED|95.0|-5.6804|-1.5614|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-1.5614|-5.6804|<0.001
72528698|NCT02055976|144587595|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-4.1778|STANDARD_ERROR_OF_MEAN|1.0269|<|0.001|TWO_SIDED|95.0|-6.2184|-2.1372|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-2.1372|-6.2184|<0.001
72528699|NCT02055976|144587595|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-3.2914|STANDARD_ERROR_OF_MEAN|1.2954||0.006|TWO_SIDED|95.0|-5.8649|-0.7178|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-0.7178|-5.8649|0.006
72528700|NCT02055976|144587595|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-6.3569|STANDARD_ERROR_OF_MEAN|1.3157|<|0.001|TWO_SIDED|95.0|-8.9706|-3.7432|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-3.7432|-8.9706|<0.001
72528701|NCT02055976|144587595|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-6.3962|STANDARD_ERROR_OF_MEAN|1.3233|<|0.001|TWO_SIDED|95.0|-9.0247|-3.7677|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-3.7677|-9.0247|<0.001
72528702|NCT02055976|144587595|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-3.9228|STANDARD_ERROR_OF_MEAN|0.9199|<|0.001|TWO_SIDED|95.0|-5.7506|-2.095|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-2.0950|-5.7506|<0.001
72528703|NCT02055976|144587595|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-4.7094|STANDARD_ERROR_OF_MEAN|0.9244|<|0.001|TWO_SIDED|95.0|-6.5459|-2.8729|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-2.8729|-6.5459|<0.001
72528704|NCT02055976|144587595|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-4.4374|STANDARD_ERROR_OF_MEAN|0.9187|<|0.001|TWO_SIDED|95.0|-6.263|-2.6118|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113:Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-2.6118|-6.2630|<0.001
72528705|NCT02055976|144587596|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-27.4492|STANDARD_ERROR_OF_MEAN|10.2401||0.004|TWO_SIDED|95.0|-47.7872|-7.1112|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-7.1112|-47.7872|0.004
72528706|NCT02055976|144587596|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-40.5908|STANDARD_ERROR_OF_MEAN|10.4568|<|0.001|TWO_SIDED|95.0|-61.3577|-19.824|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-19.8240|-61.3577|<0.001
72528707|NCT02055976|144587596|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-27.163|STANDARD_ERROR_OF_MEAN|10.5402||0.006|TWO_SIDED|95.0|-48.0927|-6.2332|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-6.2332|-48.0927|0.006
72407462|NCT03385239|144323496|SUPERIORITY||Mean Difference in % CFB|4.0||||0.6746|TWO_SIDED|95.0|-12.0|23.0|||ANCOVA||Mean difference in % CFB based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|LDL-C||23|-12|0.6746
72528708|NCT02055976|144587596|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-24.1677|STANDARD_ERROR_OF_MEAN|8.8755||0.004|TWO_SIDED|95.0|-41.8023|-6.5332|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-6.5332|-41.8023|0.004
72528709|NCT02055976|144587596|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-19.2255|STANDARD_ERROR_OF_MEAN|8.9203||0.017|TWO_SIDED|95.0|-36.9471|-1.5038|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-1.5038|-36.9471|0.017
72528710|NCT02055976|144587596|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-26.5155|STANDARD_ERROR_OF_MEAN|8.8387||0.002|TWO_SIDED|95.0|-44.0795|-8.9515|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-8.9515|-44.0795|0.002
72528711|NCT02055976|144587596|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-18.3898|STANDARD_ERROR_OF_MEAN|5.1768|<|0.001|TWO_SIDED|95.0|-28.6698|-8.1097|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-8.1097|-28.6698|<0.001
72528712|NCT02055976|144587596|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-36.7882|STANDARD_ERROR_OF_MEAN|5.264|<|0.001|TWO_SIDED|95.0|-47.2423|-26.3341|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-26.3341|-47.2423|<0.001
72528713|NCT02055976|144587596|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-36.8453|STANDARD_ERROR_OF_MEAN|5.3084|<|0.001|TWO_SIDED|95.0|-47.3864|-26.3041|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-26.3041|-47.3864|<0.001
72528714|NCT02055976|144587596|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-32.9411|STANDARD_ERROR_OF_MEAN|7.8656|<|0.001|TWO_SIDED|95.0|-48.5748|-17.3075|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-17.3075|-48.5748|<0.001
72528715|NCT02055976|144587596|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-31.3176|STANDARD_ERROR_OF_MEAN|7.9032|<|0.001|TWO_SIDED|95.0|-47.0238|-15.6114|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-15.6114|-47.0238|<0.001
72528716|NCT02055976|144587596|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-32.847|STANDARD_ERROR_OF_MEAN|7.8576|<|0.001|TWO_SIDED|95.0|-48.465|-17.2289|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113:Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-17.2289|-48.4650|<0.001
72528717|NCT02055976|144587598|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|7.663|STANDARD_ERROR_OF_MEAN|1.431|<|0.001|TWO_SIDED|95.0|4.82|10.506|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||10.506|4.820|<0.001
72571689|NCT02912650|144671805|SUPERIORITY_OR_OTHER||LS Mean Difference|0.46||||0.003|TWO_SIDED|95.0|0.16|0.76|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.76|0.16|0.003
72571690|NCT02912650|144671805|SUPERIORITY_OR_OTHER||LS Mean Difference|0.57||||0.008|TWO_SIDED|95.0|0.15|1.0|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.00|0.15|0.008
72571691|NCT02912650|144671805|SUPERIORITY_OR_OTHER||LS Mean Difference|0.22||||0.315|TWO_SIDED|95.0|-0.21|0.64|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.64|-0.21|0.315
72571692|NCT02912650|144671805|SUPERIORITY_OR_OTHER||LS Mean Difference|0.36||||0.019|TWO_SIDED|95.0|0.06|0.66|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.66|0.06|0.019
72571693|NCT02912650|144671805|SUPERIORITY_OR_OTHER||LS Mean Difference|0.45||||0.038|TWO_SIDED|95.0|0.02|0.87|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.87|0.02|0.038
72571694|NCT02912650|144671805|SUPERIORITY_OR_OTHER||LS Mean Difference|0.02||||0.918|TWO_SIDED|95.0|-0.28|0.31|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.31|-0.28|0.918
72528718|NCT02055976|144587598|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|9.29|STANDARD_ERROR_OF_MEAN|1.46|<|0.001|TWO_SIDED|95.0|6.389|12.19|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||12.190|6.389|<0.001
72625497|NCT04752566|144780356|SUPERIORITY||Odds Ratio (OR)|0.9||||0.8987|TWO_SIDED|95.0|0.27|3.17|||Regression, Logistic|||Week 8||3.17|0.27|0.8987
72528719|NCT02055976|144587598|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|7.255|STANDARD_ERROR_OF_MEAN|1.47|<|0.001|TWO_SIDED|95.0|4.336|10.175|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||10.175|4.336|<0.001
72528720|NCT02055976|144587598|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|2.228|STANDARD_ERROR_OF_MEAN|1.806||0.11|TWO_SIDED|95.0|-1.361|5.818|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||5.818|-1.361|0.110
72528721|NCT02055976|144587598|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|5.578|STANDARD_ERROR_OF_MEAN|1.815||0.001|TWO_SIDED|95.0|1.972|9.185|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||9.185|1.972|0.001
72528722|NCT02055976|144587598|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|4.712|STANDARD_ERROR_OF_MEAN|1.789||0.005|TWO_SIDED|95.0|1.156|8.268|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||8.268|1.156|0.005
72528723|NCT02055976|144587598|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|5.888|STANDARD_ERROR_OF_MEAN|2.035||0.002|TWO_SIDED|95.0|1.844|9.932|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||9.932|1.844|0.002
72528724|NCT02055976|144587598|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|9.251|STANDARD_ERROR_OF_MEAN|2.062|<|0.001|TWO_SIDED|95.0|5.153|13.349|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||13.349|5.153|<0.001
72528725|NCT02055976|144587598|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|5.264|STANDARD_ERROR_OF_MEAN|2.072||0.006|TWO_SIDED|95.0|1.147|9.38|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||9.380|1.147|0.006
72528726|NCT02055976|144587598|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|5.065|STANDARD_ERROR_OF_MEAN|1.843||0.004|TWO_SIDED|95.0|1.402|8.728|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||8.728|1.402|0.004
72528727|NCT02055976|144587598|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|5.096|STANDARD_ERROR_OF_MEAN|1.853||0.004|TWO_SIDED|95.0|1.413|8.78|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||8.780|1.413|0.004
72528728|NCT02055976|144587598|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|4.301|STANDARD_ERROR_OF_MEAN|1.832||0.011|TWO_SIDED|95.0|0.658|7.943|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113:Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||7.943|0.658|0.011
72528729|NCT02055976|144587599|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|13.389|STANDARD_ERROR_OF_MEAN|2.525|<|0.001|TWO_SIDED|95.0|8.373|18.405|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||18.405|8.373|<0.001
72528730|NCT02055976|144587599|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|16.546|STANDARD_ERROR_OF_MEAN|2.576|<|0.001|TWO_SIDED|95.0|11.43|21.663|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||21.663|11.430|<0.001
72571695|NCT02912650|144671805|SUPERIORITY_OR_OTHER||LS Mean Difference|0.25||||0.105|TWO_SIDED|95.0|-0.05|0.55|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.55|-0.05|0.105
72571696|NCT02912650|144671805|SUPERIORITY_OR_OTHER||LS Mean Difference|0.43||||0.045|TWO_SIDED|95.0|0.01|0.85|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.85|0.01|0.045
72571697|NCT02912650|144671805|SUPERIORITY_OR_OTHER||LS Mean Difference|0.2||||0.355|TWO_SIDED|95.0|-0.22|0.62|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.62|-0.22|0.355
72407463|NCT03385239|144323496|SUPERIORITY||Mean Difference in % CFB|29.0||||0.0032|TWO_SIDED|95.0|9.0|53.0|||ANCOVA||Mean difference in % CFB based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|LDL-C||53|9|0.0032
72407464|NCT03385239|144323496|SUPERIORITY||Mean Difference in % CFB|12.0||||0.1996|TWO_SIDED|95.0|-6.0|32.0|||ANCOVA||Mean difference in % CFB based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|LDL-C||32|-6|0.1996
72407465|NCT03385239|144323496|SUPERIORITY||Mean Difference in % CFB|12.0||||0.0373|TWO_SIDED|95.0|1.0|24.0|||ANCOVA||Mean difference in % CFB based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|HDL-C||24|1|0.0373
72528731|NCT02055976|144587599|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|13.288|STANDARD_ERROR_OF_MEAN|2.593|<|0.001|TWO_SIDED|95.0|8.137|18.438|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||18.438|8.137|<0.001
72528732|NCT02055976|144587599|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|4.112|STANDARD_ERROR_OF_MEAN|2.909||0.081|TWO_SIDED|95.0|-1.671|9.895|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||9.895|-1.671|0.081
72528733|NCT02055976|144587599|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|9.56|STANDARD_ERROR_OF_MEAN|2.927|<|0.001|TWO_SIDED|95.0|3.743|15.377|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||15.377|3.743|<0.001
72528734|NCT02055976|144587599|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|9.826|STANDARD_ERROR_OF_MEAN|2.878|<|0.001|TWO_SIDED|95.0|4.103|15.548|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||15.548|4.103|<0.001
72528735|NCT02055976|144587599|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|10.004|STANDARD_ERROR_OF_MEAN|3.326||0.002|TWO_SIDED|95.0|3.395|16.612|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||16.612|3.395|0.002
72528736|NCT02055976|144587599|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|16.252|STANDARD_ERROR_OF_MEAN|3.367|<|0.001|TWO_SIDED|95.0|9.56|22.943|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||22.943|9.560|<0.001
72528737|NCT02055976|144587599|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|9.571|STANDARD_ERROR_OF_MEAN|3.384||0.003|TWO_SIDED|95.0|2.847|16.295|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||16.295|2.847|0.003
72571698|NCT02912650|144671805|SUPERIORITY_OR_OTHER||LS Mean Difference|0.23||||0.127|TWO_SIDED|95.0|-0.07|0.53|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.53|-0.07|0.127
72571699|NCT02912650|144671805|SUPERIORITY_OR_OTHER||LS Mean Difference|0.29||||0.171|TWO_SIDED|95.0|-0.12|0.7|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.70|-0.12|0.171
72571700|NCT02912650|144671805|SUPERIORITY_OR_OTHER||LS Mean Difference|0.04||||0.79|TWO_SIDED|95.0|-0.25|0.33|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.33|-0.25|0.790
72625498|NCT04752566|144780356|SUPERIORITY||Odds Ratio (OR)|0.6||||0.4083|TWO_SIDED|95.0|0.18|2.02|||Regression, Logistic|||Week 24||2.02|0.18|0.4083
72625499|NCT04752566|144780357|SUPERIORITY||Odds Ratio (OR)|0.8||||0.6739|TWO_SIDED|95.0|0.24|2.54|||Regression, Logistic|||||2.54|0.24|0.6739
72625500|NCT02958865|144780365|SUPERIORITY||Mean Difference (Final Values)|-2.03|STANDARD_ERROR_OF_MEAN|0.69||0.0017|TWO_SIDED|90.0|-3.17|-0.89|||Constrained Longitudinal Data Analysis|||The null hypothesis was that the there was no difference between the distributions of the total Mayo score at Week 8 between the pooled placebo group and active arm. The treatment arm was declared efficacious if an upper limit of 2-sided 90% confidence interval for the treatment effect was below zero.||-0.89|-3.17|0.0017
72407466|NCT03385239|144323496|SUPERIORITY||Mean Difference in % CFB|34.0|||<|0.0001|TWO_SIDED|95.0|21.0|49.0|||ANCOVA||Mean difference in % CFB based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|HDL-C||49|21|<0.0001
72407467|NCT03385239|144323496|SUPERIORITY||Mean Difference in % CFB|42.0|||<|0.0001|TWO_SIDED|95.0|28.0|57.0|||ANCOVA||Mean difference in % CFB based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|HDL-C||57|28|<0.0001
72407468|NCT03385239|144323496|SUPERIORITY||Mean Difference in % CFB|30.0|||<|0.0001|TWO_SIDED|95.0|18.0|44.0|||ANCOVA||Mean difference in % CFB based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|HDL-C||44|18|<0.0001
72407469|NCT03385239|144323496|SUPERIORITY||Mean Difference in % CFB|-7.0||||0.2826|TWO_SIDED|95.0|-18.0|6.0|||ANCOVA||Mean difference in % CFB based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|Non-HDL-C||6|-18|0.2826
72407470|NCT03385239|144323496|SUPERIORITY||Mean Difference in % CFB|-24.0|||<|0.0001|TWO_SIDED|95.0|-34.0|-14.0|||ANCOVA||Mean difference in % CFB based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|Non-HDL-C||-14|-34|<0.0001
72407471|NCT03385239|144323496|SUPERIORITY||Mean Difference in % CFB|-15.0||||0.0118|TWO_SIDED|95.0|-26.0|-4.0|||ANCOVA||Mean difference in % CFB based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|Non-HDL-C||-4|-26|0.0118
72528738|NCT02055976|144587599|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|9.029|STANDARD_ERROR_OF_MEAN|2.858||0.001|TWO_SIDED|95.0|3.348|14.71|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||14.710|3.348|0.001
72528739|NCT02055976|144587599|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|8.543|STANDARD_ERROR_OF_MEAN|2.876||0.002|TWO_SIDED|95.0|2.827|14.26|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||14.260|2.827|0.002
72528740|NCT02055976|144587599|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|8.898|STANDARD_ERROR_OF_MEAN|2.84||0.001|TWO_SIDED|95.0|3.252|14.544|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113:Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||14.544|3.252|0.001
72528741|NCT02055976|144587601|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-7.462|STANDARD_ERROR_OF_MEAN|1.434|<|0.001|TWO_SIDED|95.0|-10.311|-4.614|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-4.614|-10.311|<0.001
72528742|NCT02055976|144587601|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-6.693|STANDARD_ERROR_OF_MEAN|1.469|<|0.001|TWO_SIDED|95.0|-9.61|-3.776|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-3.776|-9.610|<0.001
72528743|NCT02055976|144587601|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-8.755|STANDARD_ERROR_OF_MEAN|1.479|<|0.001|TWO_SIDED|95.0|-11.692|-5.817|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-5.817|-11.692|<0.001
72528744|NCT02055976|144587601|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.072|STANDARD_ERROR_OF_MEAN|1.773||0.484|TWO_SIDED|95.0|-3.596|3.451|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||3.451|-3.596|0.484
72528745|NCT02055976|144587601|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.701|STANDARD_ERROR_OF_MEAN|1.793||0.173|TWO_SIDED|95.0|-5.264|1.862|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||1.862|-5.264|0.173
72528746|NCT02055976|144587601|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.953|STANDARD_ERROR_OF_MEAN|1.761||0.135|TWO_SIDED|95.0|-5.452|1.546|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||1.546|-5.452|0.135
72528747|NCT02055976|144587601|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-4.447|STANDARD_ERROR_OF_MEAN|2.406||0.034|TWO_SIDED|95.0|-9.23|0.335|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||0.335|-9.230|0.034
72528748|NCT02055976|144587601|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-6.764|STANDARD_ERROR_OF_MEAN|2.442||0.003|TWO_SIDED|95.0|-11.617|-1.91|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-1.910|-11.617|0.003
72528749|NCT02055976|144587601|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-5.951|STANDARD_ERROR_OF_MEAN|2.458||0.009|TWO_SIDED|95.0|-10.836|-1.066|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-1.066|-10.836|0.009
72571701|NCT02912650|144671805|SUPERIORITY_OR_OTHER||LS Mean Difference|0.18||||0.235|TWO_SIDED|95.0|-0.12|0.47|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.47|-0.12|0.235
72571702|NCT02912650|144671805|SUPERIORITY_OR_OTHER||LS Mean Difference|0.25||||0.236|TWO_SIDED|95.0|-0.16|0.66|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.66|-0.16|0.236
72571703|NCT02912650|144671805|SUPERIORITY_OR_OTHER||LS Mean Difference|0.11||||0.599|TWO_SIDED|95.0|-0.3|0.53|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.53|-0.30|0.599
72571704|NCT02912650|144671805|SUPERIORITY_OR_OTHER||LS Mean Difference|0.14||||0.353|TWO_SIDED|95.0|-0.15|0.43|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.43|-0.15|0.353
72407472|NCT03385239|144323496|SUPERIORITY||Mean Difference in % CFB|-20.0||||0.0009|TWO_SIDED|95.0|-29.0|-9.0|||ANCOVA||Mean difference in % CFB based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|Non-HDL-C||-9|-29|0.0009
72407473|NCT03385239|144323496|SUPERIORITY||Mean Difference in % CFB|-21.0||||0.0086|TWO_SIDED|95.0|-34.0|-6.0|||ANCOVA||Mean difference in % CFB based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|VLDL-C||-6|-34|0.0086
72528750|NCT02055976|144587601|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-3.07|STANDARD_ERROR_OF_MEAN|1.915||0.056|TWO_SIDED|95.0|-6.876|0.736|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||0.736|-6.876|0.056
72528751|NCT02055976|144587601|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-2.557|STANDARD_ERROR_OF_MEAN|1.937||0.095|TWO_SIDED|95.0|-6.408|1.293|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||1.293|-6.408|0.095
72528752|NCT02055976|144587601|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-5.271|STANDARD_ERROR_OF_MEAN|1.913||0.004|TWO_SIDED|95.0|-9.074|-1.469|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113:Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-1.469|-9.074|0.004
72528753|NCT02055976|144587602|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-31.88|STANDARD_ERROR_OF_MEAN|7.071|<|0.001|TWO_SIDED|95.0|-45.925|-17.836|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-17.836|-45.925|<0.001
72528754|NCT02055976|144587602|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-29.187|STANDARD_ERROR_OF_MEAN|7.242|<|0.001|TWO_SIDED|95.0|-43.571|-14.803|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-14.803|-43.571|<0.001
72528755|NCT02055976|144587602|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-39.657|STANDARD_ERROR_OF_MEAN|7.29|<|0.001|TWO_SIDED|95.0|-54.136|-25.178|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-25.178|-54.136|<0.001
72528756|NCT02055976|144587602|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-4.681|STANDARD_ERROR_OF_MEAN|13.601||0.366|TWO_SIDED|95.0|-31.713|22.35|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||22.350|-31.713|0.366
72528757|NCT02055976|144587602|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|10.227|STANDARD_ERROR_OF_MEAN|13.586||0.773|TWO_SIDED|95.0|-16.774|37.228|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||37.228|-16.774|0.773
72528758|NCT02055976|144587602|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-2.646|STANDARD_ERROR_OF_MEAN|13.362||0.422|TWO_SIDED|95.0|-29.206|23.915|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||23.915|-29.206|0.422
72369167|NCT04672655|144248420|OTHER|||||||0.754||||||The a priori threshold for statistical significance was \< 0.05.|linear mixed effects models|||A linear mixed effects model (LMM) was used to examine outcomes measured at 3, 6, and 12 months. An unstructured covariance matrix was specified to model within-subject correlations across repeated measurements. To address missing data, the LMM utilized a likelihood-based approach under the missing-at-random (MAR) assumption, which incorporates all available data, thereby minimizing bias from incomplete follow-up measurements.||||0.754
72528759|NCT02055976|144587602|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-12.911|STANDARD_ERROR_OF_MEAN|10.309||0.107|TWO_SIDED|95.0|-33.411|7.589|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||7.589|-33.411|0.107
72571705|NCT02912650|144671805|SUPERIORITY_OR_OTHER||LS Mean Difference|0.22||||0.293|TWO_SIDED|95.0|-0.19|0.62|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.62|-0.19|0.293
72571706|NCT02912650|144671805|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0||||0.986|TWO_SIDED|95.0|-0.28|0.28|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.28|-0.28|0.986
72571707|NCT02912650|144671805|SUPERIORITY_OR_OTHER||LS Mean Difference|0.11||||0.459|TWO_SIDED|95.0|-0.18|0.39|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.39|-0.18|0.459
72571708|NCT02912650|144671805|SUPERIORITY_OR_OTHER||LS Mean Difference|0.22||||0.287|TWO_SIDED|95.0|-0.18|0.62|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.62|-0.18|0.287
72369168|NCT04672655|144248421|OTHER|||||||0.0406||||||The a priori threshold for statistical significance was \< 0.05.|linear mixed effects models|||A linear mixed effects model (LMM) was used to examine outcomes measured at 3, 6, and 12 months. An unstructured covariance matrix was specified to model within-subject correlations across repeated measurements. To address missing data, the LMM utilized a likelihood-based approach under the missing-at-random (MAR) assumption, which incorporates all available data, thereby minimizing bias from incomplete follow-up measurements.||||0.0406
72571709|NCT02912650|144671805|SUPERIORITY_OR_OTHER||LS Mean Difference|0.11||||0.6|TWO_SIDED|95.0|-0.3|0.51|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.51|-0.30|0.600
72571710|NCT02912650|144671805|SUPERIORITY_OR_OTHER||LS Mean Difference|0.11||||0.447|TWO_SIDED|95.0|-0.17|0.4|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.40|-0.17|0.447
72625501|NCT02958865|144780365|SUPERIORITY||Mean Difference (Final Values)|-3.88|STANDARD_ERROR_OF_MEAN|0.69|<|0.0001|TWO_SIDED|90.0|-5.01|-2.74|||Constrained Longitudinal Data Analysis|||The null hypothesis was that the there was no difference between the distributions of the total Mayo score at Week 8 between the pooled placebo group and active arm. The treatment arm was declared efficacious if an upper limit of 2-sided 90% confidence interval for the treatment effect was below zero.||-2.74|-5.01|< 0.0001
72625502|NCT02958865|144780365|SUPERIORITY||Mean Difference (Final Values)|-4.61|STANDARD_ERROR_OF_MEAN|0.7|<|0.0001|TWO_SIDED|90.0|-5.76|-3.46|||Constrained Longitudinal Data Analysis|||The null hypothesis was that the there was no difference between the distributions of the total Mayo score at Week 8 between the pooled placebo group and active arm. The treatment arm was declared efficacious if an upper limit of 2-sided 90% confidence interval for the treatment effect was below zero.||-3.46|-5.76|< 0.0001
72528760|NCT02055976|144587602|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-23.119|STANDARD_ERROR_OF_MEAN|10.461||0.015|TWO_SIDED|95.0|-43.923|-2.315|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-2.315|-43.923|0.015
72528761|NCT02055976|144587602|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-17.159|STANDARD_ERROR_OF_MEAN|10.535||0.054|TWO_SIDED|95.0|-38.108|3.789|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||3.789|-38.108|0.054
72528762|NCT02055976|144587602|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-24.416|STANDARD_ERROR_OF_MEAN|12.718||0.029|TWO_SIDED|95.0|-49.696|0.865|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||0.865|-49.696|0.029
72528763|NCT02055976|144587602|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-6.287|STANDARD_ERROR_OF_MEAN|12.705||0.311|TWO_SIDED|95.0|-31.541|18.968|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||18.968|-31.541|0.311
72528764|NCT02055976|144587602|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-32.443|STANDARD_ERROR_OF_MEAN|12.555||0.006|TWO_SIDED|95.0|-57.4|-7.485|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113:Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-7.485|-57.400|0.006
72528765|NCT02055976|144587604|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-35.967|STANDARD_ERROR_OF_MEAN|10.822|<|0.001|TWO_SIDED|95.0|-57.463|-14.472|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-14.472|-57.463|<0.001
72528766|NCT02055976|144587604|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-29.186|STANDARD_ERROR_OF_MEAN|11.044||0.005|TWO_SIDED|95.0|-51.123|-7.249|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-7.249|-51.123|0.005
72528767|NCT02055976|144587604|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-40.01|STANDARD_ERROR_OF_MEAN|11.16|<|0.001|TWO_SIDED|95.0|-62.175|-17.845|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-17.845|-62.175|<0.001
72528768|NCT02055976|144587604|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|3.17|STANDARD_ERROR_OF_MEAN|10.906||0.614|TWO_SIDED|95.0|-18.502|24.842|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||24.842|-18.502|0.614
72571711|NCT02912650|144671806|SUPERIORITY_OR_OTHER||LS Mean Difference|0.59||||0.001|TWO_SIDED|95.0|0.23|0.96|||ANCOVA|||0.25 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||0.96|0.23|0.001
72571712|NCT02912650|144671806|SUPERIORITY_OR_OTHER||LS Mean Difference|0.13||||0.297|TWO_SIDED|95.0|-0.12|0.39|||ANCOVA|||0.25 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||0.39|-0.12|0.297
72571713|NCT02912650|144671806|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1||||0.457|TWO_SIDED|95.0|-0.35|0.16|||ANCOVA|||0.25 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||0.16|-0.35|0.457
72571714|NCT02912650|144671806|SUPERIORITY_OR_OTHER||LS Mean Difference|0.46||||0.012|TWO_SIDED|95.0|0.1|0.82|||ANCOVA|||0.25 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||0.82|0.10|0.012
72407474|NCT03385239|144323496|SUPERIORITY||Mean Difference in % CFB|-53.0|||<|0.0001|TWO_SIDED|95.0|-60.0|-44.0|||ANCOVA||Mean difference in % CFB based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|VLDL-C||-44|-60|<0.0001
72528769|NCT02055976|144587604|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-8.563|STANDARD_ERROR_OF_MEAN|11.067||0.221|TWO_SIDED|95.0|-30.554|13.427|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||13.427|-30.554|0.221
72528770|NCT02055976|144587604|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-5.649|STANDARD_ERROR_OF_MEAN|10.933||0.303|TWO_SIDED|95.0|-27.376|16.079|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||16.079|-27.376|0.303
72528771|NCT02055976|144587604|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-22.003|STANDARD_ERROR_OF_MEAN|14.53||0.067|TWO_SIDED|95.0|-50.882|6.875|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||6.875|-50.882|0.067
72528772|NCT02055976|144587604|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-41.761|STANDARD_ERROR_OF_MEAN|14.676||0.003|TWO_SIDED|95.0|-70.934|-12.588|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-12.588|-70.934|0.003
72528773|NCT02055976|144587604|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-34.933|STANDARD_ERROR_OF_MEAN|14.832||0.01|TWO_SIDED|95.0|-64.41|-5.456|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-5.456|-64.410|0.010
72528774|NCT02055976|144587604|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-17.978|STANDARD_ERROR_OF_MEAN|11.725||0.064|TWO_SIDED|95.0|-41.282|5.326|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||5.326|-41.282|0.064
72528775|NCT02055976|144587604|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-5.654|STANDARD_ERROR_OF_MEAN|11.903||0.318|TWO_SIDED|95.0|-29.311|18.004|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||18.004|-29.311|0.318
72528776|NCT02055976|144587604|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-19.435|STANDARD_ERROR_OF_MEAN|11.807||0.052|TWO_SIDED|95.0|-42.902|4.032|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113:Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||4.032|-42.902|0.052
72528777|NCT02055976|144587605|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-25.974|STANDARD_ERROR_OF_MEAN|7.674|<|0.001|TWO_SIDED|95.0|-41.217|-10.731|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-10.731|-41.217|<0.001
72528778|NCT02055976|144587605|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-21.11|STANDARD_ERROR_OF_MEAN|7.831||0.004|TWO_SIDED|95.0|-36.665|-5.555|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-5.555|-36.665|0.004
72528779|NCT02055976|144587605|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-31.034|STANDARD_ERROR_OF_MEAN|7.917|<|0.001|TWO_SIDED|95.0|-46.758|-15.31|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-15.310|-46.758|<0.001
72528780|NCT02055976|144587605|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|8.034|STANDARD_ERROR_OF_MEAN|9.553||0.799|TWO_SIDED|95.0|-10.948|27.015|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||27.015|-10.948|0.799
72528781|NCT02055976|144587605|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-2.511|STANDARD_ERROR_OF_MEAN|9.682||0.398|TWO_SIDED|95.0|-21.748|16.727|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||16.727|-21.748|0.398
72407475|NCT03385239|144323496|SUPERIORITY||Mean Difference in % CFB|-58.0|||<|0.0001|TWO_SIDED|95.0|-64.0|-50.0|||ANCOVA||Mean difference in % CFB based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|VLDL-C||-50|-64|<0.0001
72407476|NCT03385239|144323496|SUPERIORITY||Mean Difference in % CFB|-60.0|||<|0.0001|TWO_SIDED|95.0|-66.0|-52.0|||ANCOVA||Mean difference in % CFB based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|VLDL-C||-52|-66|<0.0001
72528782|NCT02055976|144587605|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.369|STANDARD_ERROR_OF_MEAN|9.58||0.515|TWO_SIDED|95.0|-18.668|19.407|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||19.407|-18.668|0.515
72528783|NCT02055976|144587605|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-10.056|STANDARD_ERROR_OF_MEAN|8.801||0.128|TWO_SIDED|95.0|-27.549|7.437|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||7.437|-27.549|0.128
72528784|NCT02055976|144587605|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-24.352|STANDARD_ERROR_OF_MEAN|8.882||0.004|TWO_SIDED|95.0|-42.008|-6.695|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-6.695|-42.008|0.004
72528785|NCT02055976|144587605|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-14.994|STANDARD_ERROR_OF_MEAN|8.987||0.049|TWO_SIDED|95.0|-32.858|2.87|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||2.870|-32.858|0.049
72528786|NCT02055976|144587605|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-13.83|STANDARD_ERROR_OF_MEAN|9.326||0.071|TWO_SIDED|95.0|-32.368|4.709|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||4.709|-32.368|0.071
72528787|NCT02055976|144587605|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-3.378|STANDARD_ERROR_OF_MEAN|9.464||0.361|TWO_SIDED|95.0|-22.191|15.435|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||15.435|-22.191|0.361
72528788|NCT02055976|144587605|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-15.035|STANDARD_ERROR_OF_MEAN|9.389||0.056|TWO_SIDED|95.0|-33.698|3.629|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113:Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||3.629|-33.698|0.056
72528789|NCT02055976|144587607|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-76.189|STANDARD_ERROR_OF_MEAN|5.431|<|0.001|TWO_SIDED|95.0|-86.975|-65.403|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-65.403|-86.975|<0.001
72528790|NCT02055976|144587607|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-95.205|STANDARD_ERROR_OF_MEAN|5.556|<|0.001|TWO_SIDED|95.0|-106.238|-84.172|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-84.172|-106.238|<0.001
72625503|NCT02958865|144780365|SUPERIORITY||Mean Difference (Final Values)|-1.79|STANDARD_ERROR_OF_MEAN|0.68||0.0045|TWO_SIDED|90.0|-2.92|-0.67|||Constrained Longitudinal Data Analysis|||The null hypothesis was that the there is no difference between the distributions of the total Mayo score at Week 8 between the pooled placebo group and active arm. The treatment arm is declared efficacious if an upper limit of 2-sided 90% confidence interval for the treatment effect is below zero.||-0.67|-2.92|0.0045
72625504|NCT02958865|144780365|SUPERIORITY||Mean Difference (Final Values)|-2.28|STANDARD_ERROR_OF_MEAN|0.69||0.0005|TWO_SIDED|90.0|-3.41|-1.14|||Constrained Longitudinal Data Analysis|||The null hypothesis was that the there was no difference between the distributions of the total Mayo score at Week 8 between the pooled placebo group and active arm. The treatment arm was declared efficacious if an upper limit of 2-sided 90% confidence interval for the treatment effect was below zero.||-1.14|-3.41|0.0005
72625505|NCT02958865|144780365|SUPERIORITY||Mean Difference (Final Values)|-3.21|STANDARD_ERROR_OF_MEAN|0.69|<|0.0001|TWO_SIDED|90.0|-4.34|-2.08|||Constrained Longitudinal Data Analysis|||The null hypothesis was that the there was no difference between the distributions of the total Mayo score at Week 8 between the pooled placebo group and active arm. The treatment arm was declared efficacious if an upper limit of 2-sided 90% confidence interval for the treatment effect was below zero.||-2.08|-4.34|< 0.0001
72625506|NCT02958865|144780382|SUPERIORITY||Mean Difference (Final Values)|9.8||||0.0626|TWO_SIDED|90.0|-1.0|19.5|||Chan and Zhang method|||||19.5|-1.0|0.0626
72625507|NCT02958865|144780382|SUPERIORITY||Mean Difference (Final Values)|28.6||||0.0027|TWO_SIDED|90.0|13.9|41.0|||Chan and Zhang method|||||41.0|13.9|0.0027
72625508|NCT02958865|144780382|SUPERIORITY||Mean Difference (Final Values)|34.0||||0.001|TWO_SIDED|90.0|20.2|46.5|||Chan and Zhang Method|||||46.5|20.2|0.0010
72625509|NCT02958865|144780382|SUPERIORITY||Mean Difference (Final Values)|8.3||||0.0774|TWO_SIDED|90.0|-4.0|18.1|||Chan and Zhang method|||||18.1|-4.0|0.0774
72625510|NCT02958865|144780382|SUPERIORITY||Mean Difference (Final Values)|23.4||||0.0055|TWO_SIDED|90.0|8.2|35.8|||Chan and Zhang method|||||35.8|8.2|0.0055
72625511|NCT02958865|144780382|SUPERIORITY||Mean Difference (Final Values)|23.4||||0.0055|TWO_SIDED|90.0|8.2|35.8|||Chan and Zhang method|||||35.8|8.2|0.0055
72407477|NCT03385239|144323496|SUPERIORITY||Mean Difference in % CFB|2.0||||0.6801|TWO_SIDED|95.0|-7.0|13.0|||ANCOVA||Mean difference in % CFB based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|ApoB||13|-7|0.6801
72625512|NCT02958865|144780383|SUPERIORITY||Mean Difference (Final Values)|21.6||||0.0111|TWO_SIDED|90.0|5.6|33.2|||Chan and Zhang method|||||33.2|5.6|0.0111
72528791|NCT02055976|144587607|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-106.077|STANDARD_ERROR_OF_MEAN|5.622|<|0.001|TWO_SIDED|95.0|-117.239|-94.915|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-94.915|-117.239|<0.001
72528792|NCT02055976|144587607|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-71.234|STANDARD_ERROR_OF_MEAN|6.622|<|0.001|TWO_SIDED|95.0|-84.39|-58.077|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-58.077|-84.390|<0.001
72528793|NCT02055976|144587607|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-100.638|STANDARD_ERROR_OF_MEAN|6.609|<|0.001|TWO_SIDED|95.0|-113.768|-87.508|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-87.508|-113.768|<0.001
72528794|NCT02055976|144587607|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-103.386|STANDARD_ERROR_OF_MEAN|6.525|<|0.001|TWO_SIDED|95.0|-116.353|-90.42|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-90.420|-116.353|<0.001
72528795|NCT02055976|144587607|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-61.124|STANDARD_ERROR_OF_MEAN|5.382|<|0.001|TWO_SIDED|95.0|-71.813|-50.435|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-50.435|-71.813|<0.001
72528796|NCT02055976|144587607|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-81.837|STANDARD_ERROR_OF_MEAN|5.48|<|0.001|TWO_SIDED|95.0|-92.721|-70.954|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-70.954|-92.721|<0.001
72528797|NCT02055976|144587607|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-89.683|STANDARD_ERROR_OF_MEAN|5.567|<|0.001|TWO_SIDED|95.0|-100.74|-78.627|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-78.627|-100.740|<0.001
72528798|NCT02055976|144587607|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-76.747|STANDARD_ERROR_OF_MEAN|6.118|<|0.001|TWO_SIDED|95.0|-88.902|-64.593|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-64.593|-88.902|<0.001
72528799|NCT02055976|144587607|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-100.666|STANDARD_ERROR_OF_MEAN|6.098|<|0.001|TWO_SIDED|95.0|-112.781|-88.551|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-88.551|-112.781|<0.001
72528800|NCT02055976|144587607|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-109.49|STANDARD_ERROR_OF_MEAN|6.054|<|0.001|TWO_SIDED|95.0|-121.519|-97.462|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113:Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-97.462|-121.519|<0.001
72528801|NCT02055976|144587608|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-46.772|STANDARD_ERROR_OF_MEAN|3.473|<|0.001|TWO_SIDED|95.0|-53.671|-39.874|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-39.874|-53.671|<0.001
72528802|NCT02055976|144587608|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-59.2|STANDARD_ERROR_OF_MEAN|3.554|<|0.001|TWO_SIDED|95.0|-66.257|-52.143|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-52.143|-66.257|<0.001
72528803|NCT02055976|144587608|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-66.868|STANDARD_ERROR_OF_MEAN|3.595|<|0.001|TWO_SIDED|95.0|-74.007|-59.73|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-59.730|-74.007|<0.001
72625513|NCT02958865|144780383|SUPERIORITY||Mean Difference (Final Values)|34.7||||0.0006|TWO_SIDED|90.0|20.2|47.4|||Chan and Zhang method|||||47.4|20.2|0.0006
72625514|NCT02958865|144780383|SUPERIORITY||Mean Difference (Final Values)|42.0||||0.0001|TWO_SIDED|90.0|29.5|54.6|||Chan and Zhang Method|||||54.6|29.5|0.0001
72625515|NCT02958865|144780383|SUPERIORITY||Mean Difference (Final Values)|20.8||||0.0101|TWO_SIDED|90.0|5.6|33.0|||Chan and Zhang method|||||33.0|5.6|0.0101
72625516|NCT02958865|144780383|SUPERIORITY||Mean Difference (Final Values)|31.9||||0.0014|TWO_SIDED|90.0|17.0|44.8|||Chan and Zhang method|||||44.8|17.0|0.0014
72625517|NCT02958865|144780383|SUPERIORITY||Mean Difference (Final Values)|29.8||||0.0015|TWO_SIDED|90.0|17.0|42.6|||Chan and Zhang method|||||42.6|17.0|0.0015
72528804|NCT02055976|144587608|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-40.051|STANDARD_ERROR_OF_MEAN|3.595|<|0.001|TWO_SIDED|95.0|-47.195|-32.908|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-32.908|-47.195|<0.001
72407478|NCT03385239|144323496|SUPERIORITY||Mean Difference in % CFB|-16.0||||0.0007|TWO_SIDED|95.0|-24.0|-7.0|||ANCOVA||Mean difference in % CFB based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|ApoB||-7|-24|0.0007
72407479|NCT03385239|144323496|SUPERIORITY||Mean Difference in % CFB|-5.0||||0.3183|TWO_SIDED|95.0|-14.0|5.0|||ANCOVA||Mean difference in % CFB based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|ApoB||5|-14|0.3183
72407480|NCT03385239|144323496|SUPERIORITY||Mean Difference in % CFB|-10.0||||0.024|TWO_SIDED|95.0|-19.0|-1.0|||ANCOVA||Mean difference in % CFB based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|ApoB||-1|-19|0.024
72407481|NCT03385239|144323496|SUPERIORITY||Mean Difference in % CFB|5.0||||0.0936|TWO_SIDED|95.0|-1.0|11.0|||ANCOVA||Mean difference in % CFB based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|ApoA-I||11|-1|0.0936
72407482|NCT03385239|144323496|SUPERIORITY||Mean Difference in % CFB|14.0|||<|0.0001|TWO_SIDED|95.0|8.0|21.0|||ANCOVA||Mean difference in % CFB based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|ApoA-I||21|8|<0.0001
72407483|NCT03385239|144323496|SUPERIORITY||Mean Difference in % CFB|18.0|||<|0.0001|TWO_SIDED|95.0|11.0|25.0|||ANCOVA||Mean difference in % CFB based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|ApoA-I||25|11|<0.0001
72407484|NCT03385239|144323496|SUPERIORITY||Mean Difference in % CFB|14.0|||<|0.0001|TWO_SIDED|95.0|7.0|20.0|||ANCOVA||Mean difference in % CFB based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|ApoA-I||20|7|<0.0001
72407485|NCT03385239|144323497|SUPERIORITY||Odds Ratio (OR)|3.34||||0.2591|TWO_SIDED|95.0|0.41|27.2|||Regression, Logistic|||||27.20|0.41|0.2591
72407486|NCT03385239|144323497|SUPERIORITY||Odds Ratio (OR)|84.02|||<|0.0001|TWO_SIDED|95.0|9.54|740.02|||Regression, Logistic|||||740.02|9.54|<0.0001
72528805|NCT02055976|144587608|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-56.009|STANDARD_ERROR_OF_MEAN|3.587|<|0.001|TWO_SIDED|95.0|-63.135|-48.882|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-48.882|-63.135|<0.001
72528806|NCT02055976|144587608|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-57.576|STANDARD_ERROR_OF_MEAN|3.544|<|0.001|TWO_SIDED|95.0|-64.618|-50.533|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-50.533|-64.618|<0.001
72407487|NCT03385239|144323497|SUPERIORITY||Odds Ratio (OR)|322.79|||<|0.0001|TWO_SIDED|95.0|20.31|5130.99|||Regression, Logistic|||||5130.99|20.31|<0.0001
72407488|NCT03385239|144323497|SUPERIORITY||Odds Ratio (OR)|342.13|||<|0.0001|TWO_SIDED|95.0|23.72|4933.89|||Regression, Logistic|||||4933.89|23.72|<0.0001
72407489|NCT03385239|144323498|SUPERIORITY||Odds Ratio (OR)|1.25||||0.9119|TWO_SIDED|95.0|0.02|69.88|||Regression, Logistic|||||69.88|0.02|0.9119
72528807|NCT02055976|144587608|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-37.991|STANDARD_ERROR_OF_MEAN|3.389|<|0.001|TWO_SIDED|95.0|-44.721|-31.26|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-31.260|-44.721|<0.001
72528808|NCT02055976|144587608|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-50.856|STANDARD_ERROR_OF_MEAN|3.451|<|0.001|TWO_SIDED|95.0|-57.709|-44.002|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-44.002|-57.709|<0.001
72571715|NCT02912650|144671806|SUPERIORITY_OR_OTHER||LS Mean Difference|0.69|||<|0.001|TWO_SIDED|95.0|0.33|1.06|||ANCOVA|||0.25 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||1.06|0.33|<0.001
72407490|NCT03385239|144323498|SUPERIORITY||Odds Ratio (OR)|27.18||||0.0306|TWO_SIDED|95.0|1.36|542.48|||Regression, Logistic|||||542.48|1.36|0.0306
72407491|NCT03385239|144323498|SUPERIORITY||Odds Ratio (OR)|25.54||||0.0344|TWO_SIDED|95.0|1.27|514.2|||Regression, Logistic|||||514.20|1.27|0.0344
72407492|NCT03385239|144323498|SUPERIORITY||Odds Ratio (OR)|44.47||||0.0123|TWO_SIDED|95.0|2.28|866.49|||Regression, Logistic|||||866.49|2.28|0.0123
72407493|NCT01574703|144323502|SUPERIORITY_OR_OTHER|||||||0.37||||||P-value for the treatment effect from the Log-Rank test stratified by Cohort.|Log Rank|||Statistical analysis for overall treatment comparison.||||0.37
72407494|NCT01574703|144323503|SUPERIORITY_OR_OTHER|||||||0.53||||||P-value for the treatment effect from the Log-Rank test stratified by Cohort.|Log Rank|||Statistical analysis for overall treatment comparison.||||0.53
72407495|NCT01574703|144323504|SUPERIORITY_OR_OTHER|||||||0.34||||||P-value for the treatment effect from the Log-Rank test stratified by Cohort.|Log Rank|||Statistical analysis for overall treatment comparison.||||0.34
72407496|NCT01574703|144323505|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.49||||0.8375|TWO_SIDED|95.0|-5.22|4.23||P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.|Regression, Logistic|||Statistical analysis between Varenicline and Bupropion.||4.23|-5.22|0.8375
72407497|NCT01574703|144323505|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.07||||0.978|TWO_SIDED|95.0|-5.2|5.05||P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.|Regression, Logistic|||Statistical analysis between Varenicline and NRT patch.||5.05|-5.20|0.9780
72407498|NCT01574703|144323505|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-1.13||||0.6142|TWO_SIDED|95.0|-5.54|3.27||P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.|Regression, Logistic|||Statistical analysis between Varenicline and Placebo.||3.27|-5.54|0.6142
72407499|NCT01574703|144323505|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.42||||0.8602|TWO_SIDED|95.0|-4.28|5.13||P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.|Regression, Logistic|||Statistical analysis between Bupropion and NRT patch.||5.13|-4.28|0.8602
72407500|NCT01574703|144323505|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.64||||0.7217|TWO_SIDED|95.0|-4.15|2.88||P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.|Regression, Logistic|||Statistical analysis between Bupropion and Placebo.||2.88|-4.15|0.7217
72407501|NCT01574703|144323505|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-1.06||||0.6322|TWO_SIDED|95.0|-5.41|3.28||P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.|Regression, Logistic|||Statistical analysis between NRT patch and Placebo.||3.28|-5.41|0.6322
72407502|NCT01574703|144323506|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.07||||0.9687|TWO_SIDED|95.0|-3.48|3.34||P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.|Regression, Logistic|||Statistical analysis between Varenicline and Bupropion.||3.34|-3.48|0.9687
72407503|NCT01574703|144323506|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.56||||0.7905|TWO_SIDED|95.0|-3.58|4.7||P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.|Regression, Logistic|||Statistical analysis between Varenicline and NRT patch.||4.70|-3.58|0.7905
72528809|NCT02055976|144587608|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-56.354|STANDARD_ERROR_OF_MEAN|3.505|<|0.001|TWO_SIDED|95.0|-63.315|-49.393|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-49.393|-63.315|<0.001
72528810|NCT02055976|144587608|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-43.172|STANDARD_ERROR_OF_MEAN|3.647|<|0.001|TWO_SIDED|95.0|-50.417|-35.926|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-35.926|-50.417|<0.001
72528811|NCT02055976|144587608|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-56.698|STANDARD_ERROR_OF_MEAN|3.633|<|0.001|TWO_SIDED|95.0|-63.916|-49.48|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-49.480|-63.916|<0.001
72571716|NCT02912650|144671806|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.23||||0.076|TWO_SIDED|95.0|-0.49|0.02|||ANCOVA|||0.25 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||0.02|-0.49|0.076
72407504|NCT01574703|144323506|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.21||||0.8962|TWO_SIDED|95.0|-3.36|2.94||P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.|Regression, Logistic|||Statistical analysis between Varenicline and Placebo.||2.94|-3.36|0.8962
72407505|NCT01574703|144323506|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.63||||0.7767|TWO_SIDED|95.0|-3.72|4.98||P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.|Regression, Logistic|||Statistical analysis between Bupropion and NRT patch.||4.98|-3.72|0.7767
72528812|NCT02055976|144587608|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-61.305|STANDARD_ERROR_OF_MEAN|3.609|<|0.001|TWO_SIDED|95.0|-68.477|-54.134|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113:Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-54.134|-68.477|<0.001
72528813|NCT02055976|144587610|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.69928|STANDARD_ERROR_OF_MEAN|0.13216|<|0.001|TWO_SIDED|95.0|-1.96175|-1.43682|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-1.43682|-1.96175|<0.001
72528814|NCT02055976|144587610|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-2.07922|STANDARD_ERROR_OF_MEAN|0.13446|<|0.001|TWO_SIDED|95.0|-2.34622|-1.81223|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-1.81223|-2.34622|<0.001
72571717|NCT02912650|144671806|SUPERIORITY_OR_OTHER||LS Mean Difference|2.03|||<|0.001|TWO_SIDED|95.0|1.42|2.63|||ANCOVA|||0.5 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||2.63|1.42|<0.001
72571718|NCT02912650|144671806|SUPERIORITY_OR_OTHER||LS Mean Difference|0.51||||0.016|TWO_SIDED|95.0|0.1|0.93|||ANCOVA|||0.5 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||0.93|0.10|0.016
72407506|NCT01574703|144323506|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.14||||0.926|TWO_SIDED|95.0|-3.13|2.85||P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.|Regression, Logistic|||Statistical analysis between Bupropion and Placebo.||2.85|-3.13|0.9260
72407507|NCT01574703|144323506|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.77||||0.7113|TWO_SIDED|95.0|-4.85|3.31||P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.|Regression, Logistic|||Statistical analysis between NRT patch and Placebo.||3.31|-4.85|0.7113
72407508|NCT01574703|144323507|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.57||||0.8117|TWO_SIDED|95.0|-5.27|4.13||P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.|Regression, Logistic|||Statistical analysis between Varenicline and Bupropion.||4.13|-5.27|0.8117
72407509|NCT01574703|144323507|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.78||||0.7303|TWO_SIDED|95.0|-5.21|3.65||P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.|Regression, Logistic|||Statistical analysis between Varenicline and NRT patch.||3.65|-5.21|0.7303
72407510|NCT01574703|144323507|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-1.2||||0.5946|TWO_SIDED|95.0|-5.6|3.21||P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.|Regression, Logistic|||Statistical analysis between Varenicline and Placebo.||3.21|-5.60|0.5946
72528815|NCT02055976|144587610|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-2.23886|STANDARD_ERROR_OF_MEAN|0.13553|<|0.001|TWO_SIDED|95.0|-2.50795|-1.96978|||Mixed Models Analysis|||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-1.96978|-2.50795|<0.001
72528816|NCT02055976|144587610|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.43281|STANDARD_ERROR_OF_MEAN|0.16311|<|0.001|TWO_SIDED|95.0|-1.75689|-1.10872|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-1.10872|-1.75689|<0.001
72528817|NCT02055976|144587610|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-2.01501|STANDARD_ERROR_OF_MEAN|0.16217|<|0.001|TWO_SIDED|95.0|-2.33718|-1.69283|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-1.69283|-2.33718|<0.001
72528818|NCT02055976|144587610|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-2.11359|STANDARD_ERROR_OF_MEAN|0.16038|<|0.001|TWO_SIDED|95.0|-2.4323|-1.79489|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-1.79489|-2.43230|<0.001
72528819|NCT02055976|144587610|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.35298|STANDARD_ERROR_OF_MEAN|0.13609|<|0.001|TWO_SIDED|95.0|-1.62324|-1.08271|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-1.08271|-1.62324|<0.001
72528820|NCT02055976|144587610|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.79615|STANDARD_ERROR_OF_MEAN|0.1379|<|0.001|TWO_SIDED|95.0|-2.07001|-1.52229|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-1.52229|-2.07001|<0.001
72528821|NCT02055976|144587610|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.86921|STANDARD_ERROR_OF_MEAN|0.13927|<|0.001|TWO_SIDED|95.0|-2.14575|-1.59266|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-1.59266|-2.14575|<0.001
72528822|NCT02055976|144587610|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.57311|STANDARD_ERROR_OF_MEAN|0.14333|<|0.001|TWO_SIDED|95.0|-1.85788|-1.28834|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-1.28834|-1.85788|<0.001
72528823|NCT02055976|144587610|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-2.00256|STANDARD_ERROR_OF_MEAN|0.14228|<|0.001|TWO_SIDED|95.0|-2.28521|-1.7199|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-1.71990|-2.28521|<0.001
72528824|NCT02055976|144587610|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-2.20298|STANDARD_ERROR_OF_MEAN|0.14142|<|0.001|TWO_SIDED|95.0|-2.48399|-1.92197|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113:Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-1.92197|-2.48399|<0.001
72571719|NCT02912650|144671806|SUPERIORITY_OR_OTHER||LS Mean Difference|0.21||||0.33|TWO_SIDED|95.0|-0.21|0.64|||ANCOVA|||0.5 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||0.64|-0.21|0.330
72407511|NCT01574703|144323507|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.21||||0.92|TWO_SIDED|95.0|-4.27|3.85||P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.|Regression, Logistic|||Statistical analysis between Bupropion and NRT patch.||3.85|-4.27|0.9200
72407512|NCT01574703|144323507|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.62||||0.7236|TWO_SIDED|95.0|-4.09|2.84||P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.|Regression, Logistic|||Statistical analysis between Bupropion and Placebo.||2.84|-4.09|0.7236
72528825|NCT02055976|144587611|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-41.92915|STANDARD_ERROR_OF_MEAN|2.83037|<|0.001|TWO_SIDED|95.0|-47.55052|-36.30778|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-36.30778|-47.55052|<0.001
72528826|NCT02055976|144587611|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-51.08604|STANDARD_ERROR_OF_MEAN|2.88356|<|0.001|TWO_SIDED|95.0|-56.81235|-45.35973|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-45.35973|-56.81235|<0.001
72571720|NCT02912650|144671806|SUPERIORITY_OR_OTHER||LS Mean Difference|1.51|||<|0.001|TWO_SIDED|95.0|0.91|2.11|||ANCOVA|||0.5 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||2.11|0.91|<0.001
72625518|NCT02958865|144780384|SUPERIORITY||Mean Difference (Final Values)|17.2||||0.0788|TWO_SIDED|90.0|-3.4|34.4|||Chan and Zhang method|||||34.4|-3.4|0.0788
72407513|NCT01574703|144323507|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.42||||0.8201|TWO_SIDED|95.0|-4.01|3.17||P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.|Regression, Logistic|||Statistical analysis between NRT patch and Placebo.||3.17|-4.01|0.8201
72528827|NCT02055976|144587611|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-55.516|STANDARD_ERROR_OF_MEAN|2.91014|<|0.001|TWO_SIDED|95.0|-61.29424|-49.73777|||Mixed Models Analysis|||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-49.73777|-61.29424|<0.001
72528828|NCT02055976|144587611|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-33.30375|STANDARD_ERROR_OF_MEAN|3.07498|<|0.001|TWO_SIDED|95.0|-39.41376|-27.19373|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-27.19373|-39.41376|<0.001
72528829|NCT02055976|144587611|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-47.8521|STANDARD_ERROR_OF_MEAN|3.05746|<|0.001|TWO_SIDED|95.0|-53.92668|-41.77751|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-41.77751|-53.92668|<0.001
72625519|NCT02958865|144780384|SUPERIORITY||Mean Difference (Final Values)|45.4||||0.0002|TWO_SIDED|90.0|23.6|62.1|||Chan and Zhang method|||||62.1|23.6|0.0002
72528830|NCT02055976|144587611|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-48.65686|STANDARD_ERROR_OF_MEAN|3.02097|<|0.001|TWO_SIDED|95.0|-54.6606|-42.65313|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-42.65313|-54.66060|<0.001
72571721|NCT02912650|144671806|SUPERIORITY_OR_OTHER||LS Mean Difference|1.81|||<|0.001|TWO_SIDED|95.0|1.21|2.42|||ANCOVA|||0.5 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||2.42|1.21|<0.001
72571722|NCT02912650|144671806|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3||||0.163|TWO_SIDED|95.0|-0.73|0.12|||ANCOVA|||0.5 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||0.12|-0.73|0.163
72625520|NCT02958865|144780384|SUPERIORITY||Mean Difference (Final Values)|44.0||||0.0003|TWO_SIDED|90.0|23.5|60.5|||Chan and Zhang Method|||||60.5|23.5|0.0003
72625521|NCT02958865|144780384|SUPERIORITY||Mean Difference (Final Values)|17.7||||0.0773|TWO_SIDED|90.0|-4.0|35.1|||Chan and Zhang method|||||35.1|-4.0|0.0773
72625522|NCT02958865|144780384|SUPERIORITY||Mean Difference (Final Values)|29.2||||0.0136|TWO_SIDED|90.0|5.6|47.0|||Chan and Zhang method|||||47.0|5.6|0.0136
72625523|NCT02958865|144780384|SUPERIORITY||Mean Difference (Final Values)|37.7||||0.0015|TWO_SIDED|90.0|13.9|54.7|||Chan and Zhang method|||||54.7|13.9|0.0015
72407514|NCT01574703|144323508|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.21||||0.8932|TWO_SIDED|95.0|-3.22|2.81||P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.|Regression, Logistic|||Statistical analysis between Varenicline and Bupropion.||2.81|-3.22|0.8932
72625524|NCT02958865|144780385|SUPERIORITY||Mean Difference (Final Values)|3.9||||0.2259|TWO_SIDED|90.0|-6.5|11.8|||Chan and Zhang method|||||11.8|-6.5|0.2259
72625525|NCT02958865|144780385|SUPERIORITY||Mean Difference (Final Values)|8.2||||0.082|TWO_SIDED|90.0|-3.8|17.7|||Chan and Zhang method|||||17.7|-3.8|0.0820
72625526|NCT02958865|144780385|SUPERIORITY||Mean Difference (Final Values)|12.0||||0.0649|TWO_SIDED|90.0|-0.7|22.3|||Chan and Zhang Method|||||22.3|-0.7|0.0649
72625527|NCT02958865|144780385|SUPERIORITY||Mean Difference (Final Values)|2.1||||0.3777|TWO_SIDED|90.0|-8.6|9.7|||Chan and Zhang method|||||9.7|-8.6|0.3777
72571723|NCT02912650|144671806|SUPERIORITY_OR_OTHER||LS Mean Difference|3.91|||<|0.001|TWO_SIDED|95.0|3.18|4.65|||ANCOVA|||1 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||4.65|3.18|<0.001
72625528|NCT02958865|144780385|SUPERIORITY||Mean Difference (Final Values)|17.0||||0.0212|TWO_SIDED|90.0|2.9|28.6|||Chan and Zhang method|||||28.6|2.9|0.0212
72407515|NCT01574703|144323508|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.23||||0.8747|TWO_SIDED|95.0|-3.09|2.63||P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.|Regression, Logistic|||Statistical analysis between Varenicline and NRT patch.||2.63|-3.09|0.8747
72528831|NCT02055976|144587611|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-33.5292|STANDARD_ERROR_OF_MEAN|2.96599|<|0.001|TWO_SIDED|95.0|-39.42015|-27.63826|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-27.63826|-39.42015|<0.001
72528832|NCT02055976|144587611|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-43.8568|STANDARD_ERROR_OF_MEAN|3.00531|<|0.001|TWO_SIDED|95.0|-49.82617|-37.88744|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-37.88744|-49.82617|<0.001
72528833|NCT02055976|144587611|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-46.36865|STANDARD_ERROR_OF_MEAN|3.03981|<|0.001|TWO_SIDED|95.0|-52.40589|-40.33142|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-40.33142|-52.40589|<0.001
72528834|NCT02055976|144587611|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-38.06019|STANDARD_ERROR_OF_MEAN|3.1361|<|0.001|TWO_SIDED|95.0|-44.29176|-31.82863|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-31.82863|-44.29176|<0.001
72528835|NCT02055976|144587611|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-48.57807|STANDARD_ERROR_OF_MEAN|3.1135|<|0.001|TWO_SIDED|95.0|-54.76397|-42.39217|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-42.39217|-54.76397|<0.001
72528836|NCT02055976|144587611|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-51.87214|STANDARD_ERROR_OF_MEAN|3.09363|<|0.001|TWO_SIDED|95.0|-58.01968|-45.7246|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113:Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-45.72460|-58.01968|<0.001
72528837|NCT02055976|144587613|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.33157|STANDARD_ERROR_OF_MEAN|0.02639|<|0.001|TWO_SIDED|95.0|-0.38399|-0.27916|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-0.27916|-0.38399|<0.001
72528838|NCT02055976|144587613|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.44402|STANDARD_ERROR_OF_MEAN|0.02682|<|0.001|TWO_SIDED|95.0|-0.49727|-0.39077|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-0.39077|-0.49727|<0.001
72528839|NCT02055976|144587613|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.48314|STANDARD_ERROR_OF_MEAN|0.02698|<|0.001|TWO_SIDED|95.0|-0.53671|-0.42956|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-0.42956|-0.53671|<0.001
72528840|NCT02055976|144587613|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.30542|STANDARD_ERROR_OF_MEAN|0.0323|<|0.001|TWO_SIDED|95.0|-0.3696|-0.24124|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-0.24124|-0.36960|<0.001
72571724|NCT02912650|144671806|SUPERIORITY_OR_OTHER||LS Mean Difference|0.86||||0.001|TWO_SIDED|95.0|0.35|1.38|||ANCOVA|||1 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||1.38|0.35|0.001
72571725|NCT02912650|144671806|SUPERIORITY_OR_OTHER||LS Mean Difference|0.78||||0.003|TWO_SIDED|95.0|0.26|1.31|||ANCOVA|||1 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||1.31|0.26|0.003
72571726|NCT02912650|144671806|SUPERIORITY_OR_OTHER||LS Mean Difference|3.05|||<|0.001|TWO_SIDED|95.0|2.32|3.79|||ANCOVA|||1 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||3.79|2.32|<0.001
72625529|NCT02958865|144780385|SUPERIORITY||Mean Difference (Final Values)|8.5||||0.0742|TWO_SIDED|90.0|-4.2|18.4|||Chan and Zhang method|||||18.4|-4.2|0.0742
72625530|NCT02958865|144780386|SUPERIORITY||Mean Difference (Final Values)|7.8||||0.0872|TWO_SIDED|90.0|-3.4|17.1|||Chan and Zhang method|||||17.1|-3.4|0.0872
72407516|NCT01574703|144323508|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.6||||0.671|TWO_SIDED|95.0|-3.35|2.15||P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.|Regression, Logistic|||Statistical analysis between Varenicline and Placebo.||2.15|-3.35|0.6710
72407517|NCT01574703|144323508|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.02||||0.9886|TWO_SIDED|95.0|-3.32|3.27||P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.|Regression, Logistic|||Statistical analysis between Bupropion and NRT patch.||3.27|-3.32|0.9886
72407518|NCT01574703|144323508|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.39||||0.7631|TWO_SIDED|95.0|-2.92|2.14||P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.|Regression, Logistic|||Statistical analysis between Bupropion and Placebo.||2.14|-2.92|0.7631
72407519|NCT01574703|144323508|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.37||||0.8022|TWO_SIDED|95.0|-3.23|2.5||P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.|Regression, Logistic|||Statistical analysis between NRT patch and Placebo.||2.50|-3.23|0.8022
72407520|NCT01574703|144323509|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.91||||0.6441|TWO_SIDED|95.0|-4.78|2.96||P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.|Regression, Logistic|||Statistical analysis between Varenicline and Bupropion.||2.96|-4.78|0.6441
72407521|NCT01574703|144323509|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.69||||0.7327|TWO_SIDED|95.0|-4.63|3.26||P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.|Regression, Logistic|||Statistical analysis between Varenicline and NRT patch.||3.26|-4.63|0.7327
72407522|NCT01574703|144323509|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.99||||0.6109|TWO_SIDED|95.0|-4.8|2.82||P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.|Regression, Logistic|||Statistical analysis between Varenicline and Placebo.||2.82|-4.80|0.6109
72407523|NCT01574703|144323509|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.22||||0.8707|TWO_SIDED|95.0|-2.48|2.93||P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.|Regression, Logistic|||Statistical analysis between Bupropion and NRT patch.||2.93|-2.48|0.8707
72407524|NCT01574703|144323509|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.08||||0.9531|TWO_SIDED|95.0|-2.63|2.48||P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.|Regression, Logistic|||Statistical analysis between Bupropion and Placebo.||2.48|-2.63|0.9531
72407525|NCT01574703|144323509|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.3||||0.8262|TWO_SIDED|95.0|-2.99|2.39||P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.|Regression, Logistic|||Statistical analysis between NRT patch and Placebo.||2.39|-2.99|0.8262
72407526|NCT01574703|144323510|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.59||||0.6105|TWO_SIDED|95.0|-2.84|1.67||P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.|Regression, Logistic|||Statistical analysis between Varenicline and Bupropion.||1.67|-2.84|0.6105
72407527|NCT01574703|144323510|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.32||||0.7895|TWO_SIDED|95.0|-2.65|2.01||P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.|Regression, Logistic|||Statistical analysis between Varenicline and NRT patch.||2.01|-2.65|0.7895
72571727|NCT02912650|144671806|SUPERIORITY_OR_OTHER||LS Mean Difference|3.13|||<|0.001|TWO_SIDED|95.0|2.39|3.87|||ANCOVA|||1 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||3.87|2.39|<0.001
72407528|NCT01574703|144323510|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.48||||0.6804|TWO_SIDED|95.0|-2.75|1.8||P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.|Regression, Logistic|||Statistical analysis between Varenicline and Placebo.||1.80|-2.75|0.6804
72407529|NCT01574703|144323510|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.27||||0.8127|TWO_SIDED|95.0|-1.95|2.49||P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.|Regression, Logistic|||Statistical analysis between Bupropion and NRT patch.||2.49|-1.95|0.8127
72407530|NCT01574703|144323510|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.11||||0.9218|TWO_SIDED|95.0|-2.04|2.25||P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.|Regression, Logistic|||Statistical analysis between Bupropion and Placebo.||2.25|-2.04|0.9218
72407531|NCT01574703|144323510|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.16||||0.8841|TWO_SIDED|95.0|-2.32|2.0||P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.|Regression, Logistic|||Statistical analysis between NRT patch and Placebo.||2.00|-2.32|0.8841
72407532|NCT01387607|144323539|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.73|STANDARD_ERROR_OF_MEAN|0.1906||0.0001|TWO_SIDED|95.0|-1.1|-0.36||From a repeated measures analysis (MMRM) with treatment, pooled center, week, and treatment-by-week interaction as factors, and baseline value as covariate.|Mixed-effects model repeated measures|||||-0.36|-1.10|0.0001
72528841|NCT02055976|144587613|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.44143|STANDARD_ERROR_OF_MEAN|0.03183|<|0.001|TWO_SIDED|95.0|-0.50466|-0.37821|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-0.37821|-0.50466|<0.001
72528842|NCT02055976|144587613|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.46235|STANDARD_ERROR_OF_MEAN|0.03148|<|0.001|TWO_SIDED|95.0|-0.52491|-0.3998|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-0.39980|-0.52491|<0.001
72528843|NCT02055976|144587613|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.26949|STANDARD_ERROR_OF_MEAN|0.02615|<|0.001|TWO_SIDED|95.0|-0.32142|-0.21755|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-0.21755|-0.32142|<0.001
72528844|NCT02055976|144587613|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.37493|STANDARD_ERROR_OF_MEAN|0.02649|<|0.001|TWO_SIDED|95.0|-0.42754|-0.32231|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-0.32231|-0.42754|<0.001
72528845|NCT02055976|144587613|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.41199|STANDARD_ERROR_OF_MEAN|0.02676|<|0.001|TWO_SIDED|95.0|-0.46512|-0.35886|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-0.35886|-0.46512|<0.001
72528846|NCT02055976|144587613|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.31806|STANDARD_ERROR_OF_MEAN|0.02979|<|0.001|TWO_SIDED|95.0|-0.37723|-0.25888|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-0.25888|-0.37723|<0.001
72528847|NCT02055976|144587613|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.42583|STANDARD_ERROR_OF_MEAN|0.02932|<|0.001|TWO_SIDED|95.0|-0.48409|-0.36758|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-0.36758|-0.48409|<0.001
72528848|NCT02055976|144587613|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.45501|STANDARD_ERROR_OF_MEAN|0.02912|<|0.001|TWO_SIDED|95.0|-0.51287|-0.39715|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-0.39715|-0.51287|<0.001
72528849|NCT02055976|144587614|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-49.42411|STANDARD_ERROR_OF_MEAN|3.72907|<|0.001|TWO_SIDED|95.0|-56.83019|-42.01803|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-42.01803|-56.83019|<0.001
72528850|NCT02055976|144587614|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-66.63383|STANDARD_ERROR_OF_MEAN|3.7905|<|0.001|TWO_SIDED|95.0|-74.16086|-59.10681|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-59.10681|-74.16086|<0.001
72528851|NCT02055976|144587614|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-71.72901|STANDARD_ERROR_OF_MEAN|3.81541|<|0.001|TWO_SIDED|95.0|-79.30431|-64.15371|||Mixed Models Analysis|||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-64.15371|-79.30431|<0.001
72528852|NCT02055976|144587614|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-43.56596|STANDARD_ERROR_OF_MEAN|3.92236|<|0.001|TWO_SIDED|95.0|-51.35899|-35.77293|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-35.77293|-51.35899|<0.001
72528853|NCT02055976|144587614|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-62.34926|STANDARD_ERROR_OF_MEAN|3.86432|<|0.001|TWO_SIDED|95.0|-70.02607|-54.67245|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-54.67245|-70.02607|<0.001
72528854|NCT02055976|144587614|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-65.06617|STANDARD_ERROR_OF_MEAN|3.82052|<|0.001|TWO_SIDED|95.0|-72.65818|-57.47415|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-57.47415|-72.65818|<0.001
72571728|NCT02912650|144671806|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.08||||0.769|TWO_SIDED|95.0|-0.6|0.44|||ANCOVA|||1 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||0.44|-0.60|0.769
72528855|NCT02055976|144587614|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-40.52435|STANDARD_ERROR_OF_MEAN|3.66973|<|0.001|TWO_SIDED|95.0|-47.81299|-33.23571|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-33.23571|-47.81299|<0.001
72528856|NCT02055976|144587614|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-56.14495|STANDARD_ERROR_OF_MEAN|3.71641|<|0.001|TWO_SIDED|95.0|-63.52668|-48.76322|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-48.76322|-63.52668|<0.001
72528857|NCT02055976|144587614|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-61.5637|STANDARD_ERROR_OF_MEAN|3.7569|<|0.001|TWO_SIDED|95.0|-69.0251|-54.1023|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-54.10230|-69.02510|<0.001
72528858|NCT02055976|144587614|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-46.34109|STANDARD_ERROR_OF_MEAN|4.16385|<|0.001|TWO_SIDED|95.0|-54.61427|-38.06792|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-38.06792|-54.61427|<0.001
72528859|NCT02055976|144587614|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-61.3789|STANDARD_ERROR_OF_MEAN|4.09957|<|0.001|TWO_SIDED|95.0|-69.52338|-53.23443|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-53.23443|-69.52338|<0.001
72528860|NCT02055976|144587614|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-64.67274|STANDARD_ERROR_OF_MEAN|4.06866|<|0.001|TWO_SIDED|95.0|-72.75728|-56.5882|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-56.58820|-72.75728|<0.001
72528861|NCT00394654|144587657|SUPERIORITY_OR_OTHER|||||||0.168|||||||Univariate 2-sample t-test|||||||0.168
72528862|NCT00394654|144587658|SUPERIORITY_OR_OTHER|||||||0.254|||||||Univariate 2-sample t-test|||||||0.254
72528863|NCT00394654|144587659|SUPERIORITY_OR_OTHER|||||||0.677|||||||Univariate 2-sample t-test|||||||0.677
72528864|NCT00394654|144587660|SUPERIORITY_OR_OTHER|||||||0.318|||||||Univariate 2-sample t-test|||||||0.318
72528865|NCT00394654|144587661|SUPERIORITY_OR_OTHER|||||||0.798|||||||Univariate 2-sample t-test|||||||0.798
72528866|NCT00394654|144587662|SUPERIORITY_OR_OTHER|||||||0.766|||||||Univariate 2-sample t-test|||||||0.766
72528867|NCT03756285|144587692|SUPERIORITY||Least Square Means Ratio|0.25|||<|0.001|TWO_SIDED|95.0|0.12|0.52|||Mixed Models Analysis|Covariates: atrial fibrillation status at randomization, baseline value, treatment, visit, and treatment\*visit.||||0.52|0.12|<0.001
72528868|NCT03756285|144587693|SUPERIORITY||Least Square Means Ratio|0.97||||0.568|ONE_SIDED|95.0|0.74||||ANCOVA|Covariates: atrial fibrillation status at randomization, baseline value, treatment|||||0.74|0.568
72528869|NCT03756285|144587694|SUPERIORITY||Mean Difference (Final Values)|21.8||||0.407|TWO_SIDED|95.0|-30.5|74.1|||Mixed Models Analysis|Covariates: atrial fibrillation status at randomization, baseline value, treatment, visit, and treatment\*visit.||||74.1|-30.5|0.407
72528870|NCT01021293|144587698|NON_INFERIORITY|Non-inferiority of Poliorix™ vaccine as compared to OPV vaccine in terms of the immune response to poliovirus type 1 one month after the third vaccine dose. Non-inferiority in terms of immunogenicity to poliovirus antigens was demonstrated if the upper limit of the 95% confidence interval (CI) on the group difference \[Control Group minus Poliorix Group\] in the percentage of seroprotected subjects|Difference in seroprotection rate|0.0|||||TWO_SIDED|95.0|-1.28|1.24||||||Non-inferiority of Poliorix™ as compared to OPV||1.24|-1.28|
72528871|NCT01021293|144587698|NON_INFERIORITY|Non-inferiority of Poliorix™ vaccine as compared to OPV vaccine in terms of the immune response to poliovirus type 2 one month after the third vaccine dose. Non-inferiority in terms of immunogenicity to poliovirus antigens was demonstrated if the upper limit of the 95% confidence interval (CI) on the group difference \[Control Group minus Poliorix Group\] in the percentage of seroprotected subjects|Difference in seroprotection rate|0.0|||||TWO_SIDED|95.0|-1.28|1.24||||||Non-inferiority of Poliorix™ as compared to OPV||1.24|-1.28|
72528872|NCT01021293|144587698|NON_INFERIORITY|Non-inferiority of Poliorix™ vaccine as compared to OPV vaccine in terms of the immune response to poliovirus type 3 one month after the third vaccine dose. Non-inferiority in terms of immunogenicity to poliovirus antigens was demonstrated if the upper limit of the 95% confidence interval (CI) on the group difference \[Control Group minus Poliorix Group\] in the percentage of seroprotected subjects|Difference in seroprotection rate|-1.69|||||TWO_SIDED|95.0|-3.9|-0.44||||||Non-inferiority of Poliorix™ as compared to OPV||-0.44|-3.9|
72528873|NCT01005966|144587738|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-3.01||||0.2117|TWO_SIDED|95.0|-7.75|1.73||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|Analysis of variance (ANOVA) based on a mixed model with the factors subject, treatment and period was used.|Statistical tests were 2-sided with a significance level of 0.05.|Null hypothesis considered population means for NaF toothpaste and AmF toothpaste to be equal with respect to enamel remineralization potential.||1.73|-7.75|0.2117
72571729|NCT02912650|144671806|SUPERIORITY_OR_OTHER||LS Mean Difference|4.65|||<|0.001|TWO_SIDED|95.0|3.88|5.42|||ANCOVA|||1.5 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||5.42|3.88|<0.001
72571730|NCT02912650|144671806|SUPERIORITY_OR_OTHER||LS Mean Difference|0.86||||0.002|TWO_SIDED|95.0|0.32|1.4|||ANCOVA|||1.5 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||1.40|0.32|0.002
72407533|NCT01387607|144323540|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.4376||||0.1397|TWO_SIDED|95.0|0.8732|2.3667||Based on the combined categories from Cochran-Mantel-Haenszel test adjusted for pooled center.|Cochran-Mantel-Haenszel||Overall odds ratio was calculated based on Mentel-Haenszel method as pregabalin versus placebo.|Statistical analysis performed for PGIC endpoint re-categorized into much/very much improved and other.||2.3667|0.8732|0.1397
72407534|NCT01387607|144323540|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.4626||||0.151|TWO_SIDED|95.0|0.8596|2.4886||Based on the combined categories from Cochran-Mantel-Haenszel test adjusted for pooled center.|Cochran-Mantel-Haenszel||Overall odds ratio was calculated based on Mentel-Haenszel method as pregabalin versus placebo.|Statistical analysis performed for PGIC endpoint re-categorized into any improvement (participants who were very much improved or much improved or minimally improved) and other.||2.4886|0.8596|0.1510
72407535|NCT01387607|144323541|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.99|STANDARD_ERROR_OF_MEAN|1.6804||0.0762|TWO_SIDED|95.0|-6.3|0.32||From the analysis of covariate (ANCOVA) with treatment and pooled center as factors, and baseline value as covariate.|ANCOVA|||||0.32|-6.30|0.0762
72528874|NCT01005966|144587739|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|8.96||||0.0002|TWO_SIDED|95.0|4.27|13.66||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA based on a mixed model with factors subject, treatment and period was used.|Statistical tests were 2-sided with a significance level of 0.05.|Null hypothesis considered population means for the NaF toothpaste (1426ppmF) and NaF toothpaste (675ppmF) to be equal with respect to enamel remineralization potential.||13.66|4.27|0.0002
72528875|NCT01005966|144587739|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|4.57||||0.0557||95.0|-0.11|9.24||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA based on a mixed model with factors subject, treatment and period was used.|Statistical tests were 2-sided with a significance level of 0.05.|Null hypothesis considered population means for the NaF toothpaste (1426ppmF) and Na MFP/NaF toothpaste (1450ppmF) to be equal with respect to enamel remineralization potential.||9.24|-0.11|0.0557
72528876|NCT01005966|144587739|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|23.55|||<|0.0001|TWO_SIDED|95.0|18.86|28.24||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA based on a mixed model with factors subject, treatment and period was used.|Statistical tests were 2-sided with a significance level of 0.05.|Null hypothesis considered population means for the NaF toothpaste (1426ppmF) and Placebo toothpaste (0ppmF) to be equal with respect to enamel remineralization potential.||28.24|18.86|<0.0001
72528877|NCT01005966|144587739|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|4.4||||0.0625|TWO_SIDED|95.0|-0.23|9.03||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA based on a mixed model with factors subject, treatment and period was used.|Statistical tests were 2-sided with a significance level of 0.05.|Null hypothesis considered population means for the Na MFP/NaF toothpaste (1450ppmF) and NaF toothpaste (675ppmF) to be equal with respect to enamel remineralization potential.||9.03|-0.23|0.0625
72625531|NCT02958865|144780386|SUPERIORITY||Mean Difference (Final Values)|16.3||||0.0254|TWO_SIDED|90.0|3.0|27.5|||Chan and Zhang method|||||27.5|3.0|0.0254
72625532|NCT02958865|144780386|SUPERIORITY||Mean Difference (Final Values)|26.0||||0.0034|TWO_SIDED|90.0|11.0|38.1|||Chan and Zhang Method|||||38.1|11.0|0.0034
72407536|NCT01387607|144323542|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.8924||||0.0044|TWO_SIDED|95.0|1.2007|2.9827||From Cochran-Mantel-Haenszel test comparing pregabalin to placebo adjusted for pooled center.|Cochran-Mantel-Haenszel||Overall odds ratio was calculated based on Mantel-Haenszel method as pregabalin versus placebo.|||2.9827|1.2007|0.0044
72407537|NCT01387607|144323543|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.9683||||0.0189|TWO_SIDED|95.0|1.1151|3.4742||From Cochran-Mantel-Haenszel test comparing pregabalin to placebo adjusted for pooled center.|Cochran-Mantel-Haenszel||Overall odds ratio was calculated based on Mantel-Haenszel method as pregabalin versus placebo.|||3.4742|1.1151|0.0189
72407538|NCT01387607|144323544|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.427|STANDARD_ERROR_OF_MEAN|2.0152||0.09|TWO_SIDED|95.0|-7.39|0.54||From the analysis of covariance (ANCOVA) with treatment and pooled center as factors and baseline value as covariate.|ANCOVA|||||0.54|-7.39|0.0900
72407539|NCT01387607|144323545|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.527|STANDARD_ERROR_OF_MEAN|2.1858||0.2485|TWO_SIDED|95.0|-1.77|6.83||From the analysis of covariance (ANCOVA) with treatment and pooled center as factors and baseline value as covariate.|ANCOVA|||Statistical analysis for snoring.||6.83|-1.77|0.2485
72407540|NCT01387607|144323545|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.355|STANDARD_ERROR_OF_MEAN|2.265||0.2993|TWO_SIDED|95.0|-6.81|2.1||From the analysis of covariance (ANCOVA) with treatment and pooled center as factors and baseline value as covariate.|ANCOVA|||Statistical analysis for awaken short of breath.||2.10|-6.81|0.2993
72528878|NCT01005966|144587739|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|18.99|||<|0.0001|TWO_SIDED|95.0|14.36|23.61||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA based on a mixed model with factors subject, treatment and period was used.|Statistical tests were 2-sided with a significance level of 0.05.|Null hypothesis considered population means for the Na MFP/NaF toothpaste (1450ppmF) and Placebo toothpaste (0ppmF) to be equal with respect to enamel remineralization potential.||23.61|14.36|<0.0001
72528879|NCT01005966|144587739|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|14.59|||<|0.0001|TWO_SIDED|95.0|9.95|19.23||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA based on a mixed model with factors subject, treatment and period was used.|Statistical tests were 2-sided with a significance level of 0.05.|Null hypothesis considered population means for the NaF toothpaste (675ppmF) and Placebo toothpaste (0ppmF) to be equal with respect to enamel remineralization potential.||19.23|9.95|<0.0001
72528880|NCT01005966|144587739|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|7.58||||0.0017|TWO_SIDED|95.0|2.88|12.27||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA based on a mixed model with factors subject, treatment and period was used.|Statistical tests were 2-sided with a significance level of 0.05.|Null hypothesis considered population means for the AmF toothpaste (1400ppmF) and Na MFP/NaF toothpaste (1450ppmF) to be equal with respect to enamel remineralization potential.||12.27|2.88|0.0017
72625533|NCT02958865|144780386|SUPERIORITY||Mean Difference (Final Values)|6.3||||0.1565|TWO_SIDED|90.0|-4.5|15.4|||Chan and Zhang method|||||15.4|-4.5|0.1565
72625534|NCT02958865|144780386|SUPERIORITY||Mean Difference (Final Values)|14.9||||0.0288|TWO_SIDED|90.0|1.7|26.2|||Chan and Zhang method|||||26.2|1.7|0.0288
72528881|NCT01005966|144587739|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|11.97|||<|0.0001|TWO_SIDED|95.0|7.31|16.64||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA based on a mixed model with factors subject, treatment and period was used.|Statistical tests were 2-sided with a significance level of 0.05.|Null hypothesis considered population means for AmF toothpaste (1400ppmF) and NaF toothpaste (675ppmF) to be equal with respect to enamel remineralization potential.||16.64|7.31|<0.0001
72528882|NCT01005966|144587739|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|26.56|||<|0.0001|TWO_SIDED|95.0|21.88|31.24||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA based on a mixed model with factors subject, treatment and period was used.|Statistical tests were 2-sided with a significance level of 0.05.|Null hypothesis considered population means for AmF toothpaste (1400ppmF) and placebo toothpaste (0ppmF) to be equal with respect to enamel remineralization potential.||31.24|21.88|<0.0001
72528883|NCT01005966|144587740|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|37.24||||0.7912|TWO_SIDED|95.0|-239.62|314.09||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA based on a mixed model with factors subject, treatment and period was used.|Statistical tests were 2-sided with a significance level of 0.05.|Null hypothesis considered population means for the NaF toothpaste (1426ppmF) and AmF toothpaste (1400ppmF) to be equal with respect to enamel fluoride uptake potential.||314.09|-239.62|0.7912
72528884|NCT01005966|144587740|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|532.61||||0.0002|TWO_SIDED|95.0|259.06|806.16||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA based on a mixed model with factors subject, treatment and period was used.|Statistical tests were 2-sided with a significance level of 0.05.|Null hypothesis considered population means for the NaF toothpaste (1426ppmF) and Na MFP/NaF toothpaste (1450ppmF) to be equal with respect to enamel fluoride uptake potential.||806.16|259.06|0.0002
72528885|NCT01005966|144587740|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|692.91|||<|0.0001|TWO_SIDED|95.0|418.73|967.09||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA based on a mixed model with factors subject, treatment and period was used.|Statistical tests were 2-sided with a significance level of 0.05|Null hypothesis considered population means for the NaF toothpaste (1426ppmF) and NaF toothpaste (675ppmF) to be equal with respect to enamel fluoride uptake potential.||967.09|418.73|<0.0001
72528886|NCT01005966|144587740|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|1879.4|||<|0.0001|TWO_SIDED|95.0|1605.75|2153.04||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA based on a mixed model with factors subject, treatment and period was used.|Statistical tests were 2-sided with a significance level of 0.05.|Null hypothesis considered population means for the NaF toothpaste (1426ppmF) and Placebo toothpaste (0ppmF) to be equal with respect to enamel fluoride uptake potential.||2153.04|1605.75|<0.0001
72528887|NCT01005966|144587740|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|495.38||||0.0005|TWO_SIDED|95.0|221.09|769.66||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA based on a mixed model with factors subject, treatment and period was used.|Statistical tests were 2-sided with a significance level of 0.05.|Null hypothesis considered population means for AmF toothpaste (1400ppmF) and Na MFP/ NaF toothpaste (1450ppmF) and to be equal with respect to enamel fluoride uptake potential.||769.66|221.09|0.0005
72528888|NCT01005966|144587740|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|655.67|||<|0.0001|TWO_SIDED|95.0|382.41|928.93||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA based on a mixed model with factors subject, treatment and period was used.|Statistical tests were 2-sided with a significance level of 0.05.|Null hypothesis considered population means for AmF toothpaste (1400ppmF) and NaF toothpaste (675ppmF) to be equal with respect to enamel fluoride uptake potential.||928.93|382.41|<0.0001
72528889|NCT01005966|144587740|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|1842.16|||<|0.0001|TWO_SIDED|95.0|1568.73|2115.6||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA based on a mixed model with factors subject, treatment and period was used.|Statistical tests were 2-sided with a significance level of 0.05.|Null hypothesis considered population means for AmF toothpaste (1400ppmF) and placebo toothpaste (0ppmF) to be equal with respect to enamel fluoride uptake potential.||2115.60|1568.73|<0.0001
72528890|NCT01005966|144587740|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|160.3||||0.2448|TWO_SIDED|95.0|-110.58|431.18||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA based on a mixed model with factors subject, treatment and period was used.|Statistical tests were 2-sided with a significance level of 0.05.|Null hypothesis considered population means for the Na MFP/NaF toothpaste (1450ppmF) and NaF toothpaste (675ppmF) to be equal with respect to enamel fluoride uptake potential.||431.18|-110.58|0.2448
72528891|NCT01005966|144587740|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|1346.79|||<|0.0001|TWO_SIDED|95.0|1076.46|1617.11||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA based on a mixed model with factors subject, treatment and period was used.|Statistical tests were 2-sided with a significance level of 0.05.|Null hypothesis considered population means for the Na MFP/NaF toothpaste (1450ppmF) and Placebo toothpaste (0ppmF) to be equal with respect to enamel fluoride uptake potential.||1617.11|1076.46|<0.0001
72528892|NCT01005966|144587740|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|1186.49|||<|0.0001|TWO_SIDED|95.0|915.38|1457.6||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA based on a mixed model with factors subject, treatment and period was used.|Statistical tests were 2-sided with a significance level of 0.05.|Null hypothesis considered population means for the NaF toothpaste (675ppmF) and Placebo toothpaste (0ppmF) to be equal with respect to enamel fluoride uptake potential.||1457.60|915.38|<0.0001
72528893|NCT01451203|144587741|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehmann point estimate of shift|0.0|||<|0.001|TWO_SIDED|95.0|0.0|0.0||The ANCOVA on the ranks with treatment as factors and Baseline rank as covariate was used.|ANCOVA|||The mTSS was analyzed using LINEAR for the imputation of missing data at Week 52.The primary Week 52 analysis assessed whether treatment up to Week 52 with the CZP group was superior to the placebo group in mTSS at Week 52. The 2-sided null and alternative hypotheses were: H0: πC = πM Ha: πC ≠ πM where πC represented subjects in the CZP group at Week 52 and πM represented subjects in the placebo group at Week 52.||0.00|0.00|<0.001
72625535|NCT02958865|144780386|SUPERIORITY||Mean Difference (Final Values)|14.9||||0.0288|TWO_SIDED|90.0|1.7|26.2|||Chan and Zhang method|||||26.2|1.7|0.0288
72407541|NCT01387607|144323545|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|9.03|STANDARD_ERROR_OF_MEAN|2.4485||0.0003|TWO_SIDED|95.0|4.21|13.85||From the analysis of covariance (ANCOVA) with treatment and pooled center as factors and baseline value as covariate.|ANCOVA|||Statistical analysis for sleep adequacy.||13.85|4.21|0.0003
72528894|NCT01451203|144587742|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehman point estimate of shift|0.0||||0.003|TWO_SIDED|95.0|0.0|0.0|||ANCOVA|The ANCOVA on the ranks with treatment as factors and Baseline rank as covariate was used.||The mTSS was analyzed using LINEAR for the imputation of missing data at Week 24.||0.00|0.00|0.003
72528895|NCT01451203|144587743|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Fisher Exact|||||||<0.001
72528896|NCT01451203|144587744|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Fisher Exact|||||||<0.001
72528897|NCT01451203|144587745|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002|TWO_SIDED||||||Fisher Exact|||||||0.002
72528898|NCT03521089|144587762|SUPERIORITY|||||||0.0039|||||||ANCOVA|||||||0.0039
72528899|NCT03521089|144587762|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||||||1.00
72528900|NCT03521089|144587762|SUPERIORITY|||||||0.0156|||||||Wilcoxon (Mann-Whitney)|||||||0.0156
72528901|NCT03521089|144587763|SUPERIORITY|||||||0.9674|||||||ANCOVA|||||||0.9674
72528902|NCT03521089|144587763|SUPERIORITY|||||||0.0938|||||||Wilcoxon (Mann-Whitney)|||||||0.0938
72528903|NCT03521089|144587763|SUPERIORITY|||||||0.25|||||||Wilcoxon (Mann-Whitney)|||||||0.2500
72528904|NCT03521089|144587764|SUPERIORITY|||||||0.0067|||||||ANCOVA|||||||0.0067
72528905|NCT03521089|144587764|SUPERIORITY|||||||0.0313|||||||Wilcoxon (Mann-Whitney)|||||||0.0313
72625536|NCT02958865|144780387|SUPERIORITY||Mean Difference (Final Values)|3.9||||0.2259|TWO_SIDED|90.0|-6.5|11.8|||Chan and Zhang method|||||11.8|-6.5|0.2259
72528906|NCT03521089|144587764|SUPERIORITY|||||||0.75|||||||Wilcoxon (Mann-Whitney)|||||||0.7500
72528907|NCT03521089|144587765|SUPERIORITY|||||||0.3069|||||||ANCOVA|||||||0.3069
72625537|NCT02958865|144780387|SUPERIORITY||Mean Difference (Final Values)|8.2||||0.082|TWO_SIDED|90.0|-3.8|17.7|||Chan and Zhang method|||||17.7|-3.8|0.0820
72528908|NCT03521089|144587765|SUPERIORITY|||||||0.1875|||||||Wilcoxon (Mann-Whitney)|||||||0.1875
72528909|NCT03521089|144587765|SUPERIORITY|||||||0.7188|||||||Wilcoxon (Mann-Whitney)|||||||0.7188
72625538|NCT02958865|144780387|SUPERIORITY||Mean Difference (Final Values)|12.0||||0.0649|TWO_SIDED|90.0|-0.7|22.3|||Chan and Zhang Method|||||22.3|-0.7|0.0649
72407542|NCT01387607|144323546|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.286|STANDARD_ERROR_OF_MEAN|0.1114||0.0106|TWO_SIDED|95.0|0.07|0.51||From the analysis of covariance (ANCOVA) with treatment and pooled center as factors and baseline value as covariate.|ANCOVA|||Statistical analysis for quantity of sleep.||0.51|0.07|0.0106
72528910|NCT03521089|144587766|SUPERIORITY|||||||0.2609|||||||ANCOVA|||||||0.2609
72528911|NCT03521089|144587766|SUPERIORITY|||||||0.0313|||||||Wilcoxon (Mann-Whitney)|||||||0.0313
72528912|NCT03521089|144587766|SUPERIORITY|||||||0.0156|||||||Wilcoxon (Mann-Whitney)|||||||0.0156
72528913|NCT03521089|144587767|SUPERIORITY|||||||0.6951|||||||ANCOVA|||||||0.6951
72528914|NCT03521089|144587767|SUPERIORITY|||||||0.0938|||||||Wilcoxon (Mann-Whitney)|||||||0.0938
72528915|NCT03521089|144587767|SUPERIORITY|||||||0.0938|||||||Wilcoxon (Mann-Whitney)|||||||0.0938
72528916|NCT03521089|144587768|SUPERIORITY|||||||0.3592|||||||ANCOVA|||||||0.3592
72528917|NCT03521089|144587768|SUPERIORITY|||||||0.0625|||||||Wilcoxon (Mann-Whitney)|||||||0.0625
72528918|NCT03521089|144587768|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||||||1.0000
72528919|NCT05064449|144587789|OTHER||Geometric Mean Ratio (%)|116.59|||||TWO_SIDED|90.0|91.3|148.9|||||GMR (%) was calculated as 100\*(Soticlestat + Itraconazole / Soticlestat Alone).|Linear mixed-effects model was used for analysis, using fixed-effect (treatment), random-effect (participants). The point estimates and the 90 percent (%) confidence intervals (CIs) for the geometric mean ratio (GMR) of Cmax for soticlestat with versus without itraconazole were calculated by exponentiation of the point estimates of the differences between treatments and the corresponding 90% CIs from the analyses on the ln-transformed Cmax.||148.90|91.30|
72528920|NCT05064449|144587790|OTHER||Geometric Mean Ratio (%)|107.31|||||TWO_SIDED|90.0|88.02|130.83|||||GMR (%) was calculated as 100\*(Soticlestat + Mefenamic Acid / Soticlestat Alone).|Linear mixed-effects model was used for analysis, using fixed-effect (treatment), random-effect (participants). The point estimates and the 90% CIs for the GMR of Cmax for soticlestat with versus without mefenamic acid were calculated by exponentiation of the point estimates of the differences between treatments and the corresponding 90% CIs from the analyses on the ln-transformed Cmax.||130.83|88.02|
72528921|NCT05064449|144587791|OTHER||Geometric Mean Ratio (%)|123.96|||||TWO_SIDED|90.0|106.21|144.68|||||GMR (%) was calculated as 100\*(Soticlestat + Itraconazole / Soticlestat Alone).|Linear mixed-effects model was used for analysis, using fixed-effect (treatment), random-effect (participants). The point estimates and the 90% CIs for the GMR of AUC∞ for soticlestat with versus without itraconazole were calculated by exponentiation of the point estimates of the differences between treatments and the corresponding 90% CIs from the analyses on the ln-transformed AUC∞.||144.68|106.21|
72528922|NCT05064449|144587792|OTHER||Geometric Mean Ratio (%)|100.57|||||TWO_SIDED|90.0|86.17|117.38|||||GMR (%) was calculated as 100\*(Soticlestat + Mefenamic Acid / Soticlestat Alone).|Linear mixed-effects model was used for analysis, using fixed-effect (treatment), random-effect (participants). The point estimates and the 90% CIs for the GMR of AUC∞ for soticlestat with versus without mefenamic acid were calculated by exponentiation of the point estimates of the differences between treatments and the corresponding 90% CIs from the analyses on the ln-transformed AUC∞.||117.38|86.17|
72528923|NCT05064449|144587793|OTHER||Geometric Mean Ratio (%)|121.97|||||TWO_SIDED|90.0|103.47|143.79|||||GMR (%) was calculated as 100\*(Soticlestat + Itraconazole / Soticlestat Alone).|Linear mixed-effects model was used for analysis, using fixed-effect (treatment), random-effect (participants). The point estimates and the 90% CIs for the GMR of AUClast for soticlestat with versus without itraconazole were calculated by exponentiation of the point estimates of the differences between treatments and the corresponding 90% CIs from the analyses on the ln-transformed AUClast.||143.79|103.47|
72625539|NCT02958865|144780387|SUPERIORITY||Mean Difference (Final Values)|0.0||||1|TWO_SIDED|90.0|-11.3|6.1|||Chan and Zhang method|||||6.1|-11.3|1.0000
72625540|NCT02958865|144780387|SUPERIORITY||Mean Difference (Final Values)|14.9||||0.0288|TWO_SIDED|90.0|1.7|26.2|||Chan and Zhang method|||||26.2|1.7|0.0288
72625541|NCT02958865|144780387|SUPERIORITY||Mean Difference (Final Values)|6.4||||0.1593|TWO_SIDED|90.0|-4.4|15.7|||Chan and Zhang method|||||15.7|-4.4|0.1593
72407543|NCT01387607|144323546|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.194|STANDARD_ERROR_OF_MEAN|1.6428||0.0112|TWO_SIDED|95.0|0.96|7.43||From the analysis of covariance (ANCOVA) with treatment and pooled center as factors and baseline value as covariate.|ANCOVA|||Statistical analysis for somnolence||7.43|0.96|0.0112
72407544|NCT01387607|144323547|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.059|STANDARD_ERROR_OF_MEAN|1.6438||0.0637|TWO_SIDED|95.0|-6.29|0.18||From the analysis of covariance (ANCOVA) with treatment and pooled center as factors and baseline value as covariate.|ANCOVA|||||0.18|-6.29|0.0637
72407545|NCT01387607|144323548|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.12||||0.6767|TWO_SIDED|95.0|0.67|1.87||Logistic regression model includes treatment and pooled center as factors and baseline value as covariate.|Regression, Logistic|||||1.87|0.67|0.6767
72407546|NCT01387607|144323549|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.882|STANDARD_ERROR_OF_MEAN|0.1932|<|0.0001|TWO_SIDED|95.0|-1.26|-0.5||From a repeated measures analysis (MMRM) with treatment, pooled center, week, and treatment-by-week interaction as factors, and baseline value as covariate.|Mixed-effects model repeated measures|||||-0.50|-1.26|<0.0001
72528924|NCT05064449|144587794|OTHER||Geometric Mean Ratio (%)|107.38|||||TWO_SIDED|90.0|91.68|125.77|||||GMR (%) was calculated as 100\*(Soticlestat + Mefenamic Acid / Soticlestat Alone).|Linear mixed-effects model was used for analysis, using fixed-effect (treatment), random-effect (participants). The point estimates and the 90% CIs for the GMR of AUClast for soticlestat with versus without mefenamic acid were calculated by exponentiation of the point estimates of the differences between treatments and the corresponding 90% CIs from the analyses on the ln-transformed AUClast.||125.77|91.68|
72625542|NCT02329587|144780425|OTHER||Between-group effect size (Hedge's g)|0.138|||||TWO_SIDED|||||||||||||
72407547|NCT01387607|144323550|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-17.172|STANDARD_ERROR_OF_MEAN|7.7785||0.0273|TWO_SIDED|95.0|-32.42|-1.92||From a repeated measures analysis (MMRM) with treatment, pooled center, week, and treatment-by-week interaction as factors, and baseline value as covariate.|Mixed-effects model repeated measures|||||-1.92|-32.42|0.0273
72407548|NCT01387607|144323551|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.016|STANDARD_ERROR_OF_MEAN|0.0677||0.8082|TWO_SIDED|95.0|-0.12|0.15||From a repeated measures analysis (MMRM) with treatment, pooled center, week, and treatment-by-week interaction as factors, and baseline value as covariate.|Mixed-effects model repeated measures|||||0.15|-0.12|0.8082
72407549|NCT01387607|144323552|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.655|STANDARD_ERROR_OF_MEAN|0.1223|<|0.0001|TWO_SIDED|95.0|-0.89|-0.41||From a repeated measures analysis (MMRM) with treatment, pooled center, week, and treatment-by-week interaction as factors, and baseline value as covariate.|Mixed-effects model repeated measures|||||-0.41|-0.89|<0.0001
72407550|NCT01387607|144323553|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|7.396|STANDARD_ERROR_OF_MEAN|7.7309||0.3388|TWO_SIDED|95.0|-7.76|22.55||From a repeated measures analysis (MMRM) with treatment, pooled center, week, and treatment-by-week interaction as factors, and baseline value as covariate.|Mixed-effects model repeated measures|||||22.55|-7.76|0.3388
72407551|NCT01387607|144323554|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.765|STANDARD_ERROR_OF_MEAN|0.2115||0.0003|TWO_SIDED|95.0|0.35|1.18||From a repeated measures analysis (MMRM) with treatment, pooled center, week, and treatment-by-week interaction as factors, and baseline value as covariate.|Mixed-effects model repeated measures|||||1.18|0.35|0.0003
72407552|NCT01387607|144323555|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.84|STANDARD_ERROR_OF_MEAN|0.8414||0.3186|TWO_SIDED|95.0|-2.5|0.82||From the analysis of covariate (ANCOVA) with treatment and pooled center as factors, and baseline value as covariate.|ANCOVA|||||0.82|-2.50|0.3186
72407553|NCT01387607|144323556|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.38|STANDARD_ERROR_OF_MEAN|1.0404||0.7149|TWO_SIDED|95.0|-1.67|2.43||From the analysis of covariate (ANCOVA) with treatment and pooled center as factors, and baseline value as covariate.|ANCOVA|||||2.43|-1.67|0.7149
72407554|NCT01387607|144323557|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.785|STANDARD_ERROR_OF_MEAN|0.673||0.2442|TWO_SIDED|95.0|-0.54|2.11||From the analysis of covariate (ANCOVA) with treatment and pooled center as factors, and baseline value as covariate.|ANCOVA|||||2.11|-0.54|0.2442
72407555|NCT01387607|144323558|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.616|STANDARD_ERROR_OF_MEAN|2.4019||0.1332|TWO_SIDED|95.0|-8.34|1.11||From the analysis of covariate (ANCOVA) with treatment and pooled center as factors, and baseline value as covariate.|ANCOVA|||||1.11|-8.34|0.1332
72407556|NCT01387607|144323559|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.378|STANDARD_ERROR_OF_MEAN|0.3595||0.2934||95.0|-1.09|0.33||From the analysis of covariate (ANCOVA) with treatment and pooled center as factors, and baseline value as covariate.|ANCOVA|||||0.33|-1.09|0.2934
72407557|NCT01387607|144323560|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.83|STANDARD_ERROR_OF_MEAN|0.3621||0.0226|TWO_SIDED|95.0|-1.54|-0.12||From the analysis of covariate (ANCOVA) with treatment and pooled center as factors, and baseline value as covariate.|ANCOVA|||||-0.12|-1.54|0.0226
72407558|NCT02908529|144323563|SUPERIORITY||Median Difference (Final Values)|-15.9|||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<0.001
72407559|NCT03337724|144323565|SUPERIORITY||Stratified Hazard Ratio|1.02||||0.9237|TWO_SIDED|95.0|0.71|1.45|||Log Rank||Stratification variables were: prior adjuvant/neoadjuvant chemotherapy (yes vs. no), region, tumor PIK3CA/AKT1/PTEN alteration status (PIK3CA/AKT1-activating mutations vs. PTEN alterations with no PIK3CA/AKT1-activating mutations).|||1.45|0.71|0.9237
72528925|NCT05064449|144587795|OTHER||Median Difference (Final Values)|0.003|||=|0.2305|TWO_SIDED|90.0|-0.001|0.126|||Wilcoxon Signed Rank Test||Difference was calculated as (Soticlestat + Itraconazole) - Soticlestat Alone. The difference of medians (treatment effect) and the corresponding 90% CI was estimated using the Hodges-Lehmann method and Walsh Averages.|||0.126|-0.001|=0.2305
72528926|NCT05064449|144587796|OTHER||Median Difference (Final Values)|-0.096|||=|0.583|TWO_SIDED|90.0|-0.128|0.018|||Wilcoxon Signed Rank Test||Difference was calculated as (Soticlestat + Mefenamic Acid) - Soticlestat Alone. The difference of medians (treatment effect) and the corresponding 90% was estimated using the Hodges-Lehmann method and Walsh Averages.|||0.018|-0.128|=0.5830
72625543|NCT02329587|144780426|OTHER||Between-group effect size (Hedge's g)|-0.214|||||TWO_SIDED|||||||||||||
72625544|NCT02329587|144780427|OTHER||Between-groups effect size (Hedge's g)|-0.007|||||TWO_SIDED|||||||||||||
72625545|NCT02329587|144780428|OTHER||Between-group effect size (Hedge's g)|-0.151|||||TWO_SIDED|||||||||||||
72625546|NCT02329587|144780429|OTHER||Between-groups effect size (Hedge's g)|0.704|||||TWO_SIDED|||||||||||||
72528927|NCT00125138|144587818|SUPERIORITY_OR_OTHER||Difference of LS Mean|0.1||||0.5177|TWO_SIDED|95.0|-6.3|6.6||One-sided pairwise p-value comparing each active treatment to placebo.|ANCOVA|One-way ANCOVA: Treatment, country, and baseline anti-psychotic medication status (recent or distant) as factors; baseline measurement as a covariate||The null hypothesis for each endpoint is that each melperone dose has the same mean as placebo; the alternative hypothesis is that at least one dose is more efficacious than placebo. Only subjects with both a baseline and Day 43 (end of Maintenance Phase) value are included.||6.6|-6.3|0.5177
72528928|NCT00125138|144587818|SUPERIORITY_OR_OTHER||Difference of LS mean|-2.9||||0.1519|TWO_SIDED|95.0|-8.5|2.7||One-sided pairwise p-value comparing each active treatment to placebo.|ANCOVA|One-way ANCOVA: Treatment, country, and baseline anti-psychotic medication status (recent or distant) as factors; baseline measurement as a covariate.||The null hypothesis for each endpoint is that each melperone dose has the same mean as placebo; the alternative hypothesis hypothesis is that at least one dose is more efficacious than placebo. Only subjects with both a baseline and Day 43 (end of Maintenance Phase) value are included.||2.7|-8.5|0.1519
72528929|NCT00125138|144587818|SUPERIORITY_OR_OTHER||Difference of LS mean|0.3||||0.5406|TWO_SIDED|95.0|-5.2|5.8||One-sided pairwise p-value comparing each active treatment to placebo.|ANCOVA|One-way ANCOVA: Treatment, country, and baseline anti-psychotic medication status (recent or distant) as factors; baseline measurement as a covariate.||The null hypothesis for each endpoint is that each melperone dose has the same mean as placebo; the alternative hypothesis is that at least one dose is more efficacious than placebo. Only subjects with both a baseline and Day 43 (end of Maintenance Phase) value are included.||5.8|-5.2|0.5406
72528930|NCT00125138|144587819|SUPERIORITY_OR_OTHER|||||||0.9212||95.0||||Overall p-value using a one-way ANCOVA.|ANCOVA|One-way ANCOVA: Treatment, country, and baseline anti-psychotic medication status (recent or distant) as factors; baseline measurement as a covariate.||Only subjects with both a baseline and a post-baseline value are included.||||0.9212
72528931|NCT00041119|144587820|SUPERIORITY|If the 5-year DFS for 4 cycles is 84.7% then a decrease of 23% in hazard rate for 6 cycles corresponds to an increase in 5-year DFS to 88%. Assuming a 2-sided significance level of 0.05, there is 90.9% power to detect such an increase at the final analysis conducted 6.4 years after study activation.|Hazard Ratio (HR)|1.03|||||TWO_SIDED|95.0|0.84|1.28||||||The null hypothesis is that the hazards of both 6 and 4 cycle regimens are equal. The alternative hypothesis is a hazard ratio of 0.77, corresponding to a decrease of 23% in hazard due to longer duration of chemotherapy.||1.28|0.84|
72528932|NCT00041119|144587821|EQUIVALENCE|For T to be considered equivalent to the standard CA, a confidence interval of the hazard ratio of T to CA should be wholly to the left of 1.3, corresponding to a 30% increase in hazard rate. If the 5-year DFS for CA is 88% then an increase of 30% in hazard rate for T corresponds to 5-year DFS of 84.7%. The null hypothesis is that the hazard ratio of T to CA exceeds 1.3. The alternative hypothesis is that the two hazard rates are equivalent.|Hazard Ratio (HR)|1.26|||||ONE_SIDED|95.0||1.48||||||||1.48||
72528933|NCT00041119|144587822|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were designed to detect effects in the marginal distributions of the two study factors, agent and length, and assume no interaction between the two factors. Calculations also assume exponential DFS and a total of 4556 treated patients accrued over 29 months and followed for four years after accrual termination for a total study time of 6.4 years. We assume the 5-year DFS of CA therapy is 88% and 84.7% for T. These assumptions are based upon results of SWOG 8897.|Hazard Ratio (HR)|1.27|||||ONE_SIDED|95.0||1.56||||||||1.56||
72528934|NCT00041119|144587826|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were designed to detect effects in the marginal distributions of the two study factors, agent and length, and assume no interaction between the two factors. Calculations also assume exponential DFS and a total of 4556 treated patients accrued over 29 months and followed for four years after accrual termination for a total study time of 6.4 years.|Hazard Ratio (HR)|1.12|||||TWO_SIDED|95.0|0.84|1.49||||||||1.49|.84|
72528935|NCT01258738|144587833|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.64||||0.0062|TWO_SIDED|95.0|5.36|27.92||P-value \<0.05 was required to declare statistical significance.|Cochran-Mantel-Haenszel|||"The null hypothesis was that the efficacy of etanercept was not different from placebo as measured by the proportion of subjects achieving an ASAS 40 response after 12 weeks of treatment. The alternative hypothesis was that the efficacy of etanercept was different from placebo.~The primary endpoint was tested at 2-sided alpha = 0.05 significance level. Comparative analysis was carried out for Week 12 data only."||27.92|5.36|0.0062
72528936|NCT01258738|144587834|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.46||||0.0059|TWO_SIDED|95.0|3.69|19.24|||Cochran-Mantel-Haenszel|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2||19.24|3.69|0.0059
72528937|NCT01258738|144587834|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.19||||0.3786|TWO_SIDED|95.0|-4.98|15.35|||Cochran-Mantel-Haenszel|||"Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made.~Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4"||15.35|-4.98|0.3786
72528938|NCT01258738|144587834|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.83||||0.0304|TWO_SIDED|95.0|1.79|23.87|||Cochran-Mantel-Haenszel|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8||23.87|1.79|0.0304
72625547|NCT02329587|144780430|OTHER||Odds Ratio (OR)|1.125|||||TWO_SIDED|||||||||||||
72625548|NCT01728246|144780431|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
72625549|NCT01728246|144780432|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
72625550|NCT01728246|144780434|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
72625551|NCT01983111|144780437|NON_INFERIORITY_OR_EQUIVALENCE|In the PP set, for a non-inferiority test of the reduction in the pain intensity score from Visit 1 (Baseline) to Week 6 of treatment, the lower limit of the 97.5% onesided confidence interval was compared to a clinical non-inferiority margin, -1.5.|Mean Difference (Final Values)|-0.43|STANDARD_DEVIATION|1.79||0.2658|TWO_SIDED|97.5|-6.0|3.0|||t-test, 2 sided|||In the Per protocol set||3|-6|0.2658
72571731|NCT02912650|144671806|SUPERIORITY_OR_OTHER||LS Mean Difference|1.38|||<|0.001|TWO_SIDED|95.0|0.83|1.93|||ANCOVA|||1.5 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||1.93|0.83|<0.001
72571732|NCT02912650|144671806|SUPERIORITY_OR_OTHER||LS Mean Difference|3.79|||<|0.001|TWO_SIDED|95.0|3.02|4.56|||ANCOVA|||1.5 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||4.56|3.02|<0.001
72528939|NCT01258738|144587834|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|18.52||||0.0023|TWO_SIDED|95.0|7.29|29.75|||Cochran-Mantel-Haenszel|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12||29.75|7.29|0.0023
72528940|NCT01258738|144587835|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.44||||0.0189|TWO_SIDED|95.0|3.2|25.68|||Cochran-Mantel-Haenszel|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2||25.68|3.20|0.0189
72528941|NCT01258738|144587835|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.29||||0.0983|TWO_SIDED|95.0|-2.17|22.75|||Cochran-Mantel-Haenszel|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4||22.75|-2.17|0.0983
72528942|NCT01258738|144587835|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.61||||0.0867|TWO_SIDED|95.0|-2.63|23.84|||Cochran-Mantel-Haenszel|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8||23.84|-2.63|0.0867
72528943|NCT01258738|144587835|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.27||||0.0195|TWO_SIDED|95.0|3.1|29.43|||Cochran-Mantel-Haenszel|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12||29.43|3.10|0.0195
72528944|NCT01258738|144587836|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|22.63|||<|0.0001|TWO_SIDED|95.0|11.85|33.41|||Cochran-Mantel-Haenszel|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12||33.41|11.85|<0.0001
72528945|NCT01258738|144587836|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.83||||0.0021|TWO_SIDED|95.0|5.09|20.57|||Cochran-Mantel-Haenszel|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2||20.57|5.09|0.0021
72528946|NCT01258738|144587836|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.89||||0.002|TWO_SIDED|95.0|5.18|24.6|||Cochran-Mantel-Haenszel|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4||24.60|5.18|0.0020
72528947|NCT01258738|144587836|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|21.79|||<|0.0001|TWO_SIDED|95.0|10.92|32.67|||Cochran-Mantel-Haenszel|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8||32.67|10.92|<0.0001
72528948|NCT01258738|144587837|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||All within group comparisons to baseline were \<0.001, from paired t-test. For open-label period results include unadjusted mean changes and standard errors, no covariate adjustments were applied.||||<0.001
72528949|NCT01258738|144587837|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.54|||<|0.001|TWO_SIDED|95.0|-0.74|-0.34|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2||-0.34|-0.74|<0.001
72528950|NCT01258738|144587837|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.61|||<|0.001|TWO_SIDED|95.0|-0.81|-0.41|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4||-0.41|-0.81|<0.001
72528951|NCT01258738|144587837|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.61|||<|0.001|TWO_SIDED|95.0|-0.85|-0.37|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8||-0.37|-0.85|<0.001
72571733|NCT02912650|144671806|SUPERIORITY_OR_OTHER||LS Mean Difference|3.27|||<|0.001|TWO_SIDED|95.0|2.49|4.04|||ANCOVA|||1.5 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||4.04|2.49|<0.001
72571734|NCT02912650|144671806|SUPERIORITY_OR_OTHER||LS Mean Difference|0.52||||0.062|TWO_SIDED|95.0|-0.03|1.06|||ANCOVA|||1.5 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||1.06|-0.03|0.062
72571735|NCT02912650|144671806|SUPERIORITY_OR_OTHER||LS Mean Difference|4.83|||<|0.001|TWO_SIDED|95.0|4.01|5.64|||ANCOVA|||2 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||5.64|4.01|<0.001
72571736|NCT02912650|144671806|SUPERIORITY_OR_OTHER||LS Mean Difference|0.76||||0.009|TWO_SIDED|95.0|0.19|1.33|||ANCOVA|||2 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||1.33|0.19|0.009
72571737|NCT02912650|144671806|SUPERIORITY_OR_OTHER||LS Mean Difference|1.75|||<|0.001|TWO_SIDED|95.0|1.17|2.33|||ANCOVA|||2 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||2.33|1.17|<0.001
72528952|NCT01258738|144587838|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.84||||0.0209|TWO_SIDED|95.0|2.58|23.09|||Cochran-Mantel-Haenszel|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12||23.09|2.58|0.0209
72571738|NCT02912650|144671806|SUPERIORITY_OR_OTHER||LS Mean Difference|4.06|||<|0.001|TWO_SIDED|95.0|3.25|4.88|||ANCOVA|||2 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||4.88|3.25|<0.001
72571739|NCT02912650|144671806|SUPERIORITY_OR_OTHER||LS Mean Difference|3.08|||<|0.001|TWO_SIDED|95.0|2.26|3.9|||ANCOVA|||2 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||3.90|2.26|<0.001
72528953|NCT01258738|144587838|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.65||||0.0179|TWO_SIDED|95.0|1.82|15.48|||Cochran-Mantel-Haenszel|||"Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only.~Week 2"||15.48|1.82|0.0179
72528954|NCT01258738|144587838|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.81||||0.0611|TWO_SIDED|95.0|-0.03|13.65|||Cochran-Mantel-Haenszel|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4||13.65|-0.03|0.0611
72528955|NCT01258738|144587838|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.73||||0.0141|TWO_SIDED|95.0|3.14|22.32|||Cochran-Mantel-Haenszel|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8||22.32|3.14|0.0141
72528956|NCT01258738|144587838|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||All within group comparisons to baseline were \<0.001, from paired t-test. For open-label period results include unadjusted mean changes and standard errors, no covariate adjustments were applied.||||<0.001
72625552|NCT01968980|144780503|SUPERIORITY_OR_OTHER||Least square (LS) mean difference|-54.5|STANDARD_ERROR_OF_MEAN|2.54|<|0.001|TWO_SIDED|95.0|-59.5|-49.5|||Mixed Model Repeated Measures (MMRM)|||LS-mean difference,associated 95 percent (%) confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region.||-49.5|-59.5|<0.001
72625553|NCT01968980|144780504|SUPERIORITY_OR_OTHER||LS mean difference|-37.6|STANDARD_ERROR_OF_MEAN|1.77|<|0.001|TWO_SIDED|95.0|-41.1|-34.1|||MMRM|||LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region.||-34.1|-41.1|<0.001
72369169|NCT04672655|144248422|OTHER|||||||0.9032||||||The a priori threshold for statistical significance was \< 0.05.|linear mixed effects models|||A linear mixed effects model (LMM) was used to examine outcomes measured at 3, 6, and 12 months. An unstructured covariance matrix was specified to model within-subject correlations across repeated measurements. To address missing data, the LMM utilized a likelihood-based approach under the missing-at-random (MAR) assumption, which incorporates all available data, thereby minimizing bias from incomplete follow-up measurements.||||0.9032
72528957|NCT01258738|144587839|SUPERIORITY_OR_OTHER|||||||0.0022|TWO_SIDED||||||Log Rank|||"Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made.~Comparative analysis was carried out for Week 12 data only."||||0.0022
72407560|NCT03337724|144323566|SUPERIORITY||Stratified Hazard Ratio|1.0||||0.9965|TWO_SIDED|95.0|0.71|1.4|||Log Rank||Stratification variables were: prior adjuvant/neoadjuvant chemotherapy (yes vs. no), region, prior therapy with a PI3K or mTOR inhibitor (yes vs. no).|||1.40|0.71|0.9965
72528958|NCT01258738|144587840|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||All within group comparisons to baseline were \<0.001, from paired t-test. For open-label period results include unadjusted mean changes and standard errors, no covariate adjustments were applied.||||<0.001
72571740|NCT02912650|144671806|SUPERIORITY_OR_OTHER||LS Mean Difference|0.98|||<|0.001|TWO_SIDED|95.0|0.41|1.56|||ANCOVA|||2 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||1.56|0.41|<0.001
72571741|NCT02912650|144671806|SUPERIORITY_OR_OTHER||LS Mean Difference|4.67|||<|0.001|TWO_SIDED|95.0|3.82|5.52|||ANCOVA|||3 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||5.52|3.82|<0.001
72571742|NCT02912650|144671806|SUPERIORITY_OR_OTHER||LS Mean Difference|0.78||||0.01|TWO_SIDED|95.0|0.19|1.38|||ANCOVA|||3 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||1.38|0.19|0.010
72571743|NCT02912650|144671806|SUPERIORITY_OR_OTHER||LS Mean Difference|2.41|||<|0.001|TWO_SIDED|95.0|1.81|3.01|||ANCOVA|||3 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||3.01|1.81|<0.001
72571744|NCT02912650|144671806|SUPERIORITY_OR_OTHER||LS Mean Difference|3.89|||<|0.001|TWO_SIDED|95.0|3.04|4.74|||ANCOVA|||3 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||4.74|3.04|<0.001
72571745|NCT02912650|144671806|SUPERIORITY_OR_OTHER||LS Mean Difference|2.26|||<|0.001|TWO_SIDED|95.0|1.4|3.11|||ANCOVA|||3 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||3.11|1.40|<0.001
72625554|NCT01968980|144780505|SUPERIORITY_OR_OTHER||LS mean difference|-51.0|STANDARD_ERROR_OF_MEAN|2.36|<|0.001|TWO_SIDED|95.0|-55.7|-46.4|||MMRM|||LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region.||-46.4|-55.7|<0.001
72528959|NCT01258738|144587840|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7||||0.0156|TWO_SIDED|95.0|-1.26|-0.13|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12||-0.13|-1.26|0.0156
72528960|NCT01258738|144587840|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6||||0.0111|TWO_SIDED|95.0|-1.06|-0.14|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2||-0.14|-1.06|0.0111
72528961|NCT01258738|144587840|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.42||||0.0936|TWO_SIDED|95.0|-0.91|0.07|||Cochran-Mantel-Haenszel|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4||0.07|-0.91|0.0936
72528962|NCT01258738|144587840|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.29||||0.2678|TWO_SIDED|95.0|-0.81|0.23|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8||0.23|-0.81|0.2678
72528963|NCT01258738|144587841|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||All within group comparisons to baseline were \<0.001, from paired t-test. For open-label period results included unadjusted mean changes and standard errors, no covariate adjustments were applied.||||<0.001
72528964|NCT01258738|144587841|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8||||0.0102|TWO_SIDED|95.0|-1.4|-0.19|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12||-0.19|-1.40|0.0102
72528965|NCT01258738|144587841|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.92||||0.0007|TWO_SIDED|95.0|-1.44|-0.39|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2||-0.39|-1.44|0.0007
72528966|NCT01258738|144587841|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.79||||0.0057|TWO_SIDED|95.0|-1.35|-0.23|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4||-0.23|-1.35|0.0057
72528967|NCT01258738|144587841|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.83||||0.0077|TWO_SIDED|95.0|-1.44|-0.22|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8||-0.22|-1.44|0.0077
72528968|NCT01258738|144587842|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||All within group comparisons to baseline were \<0.001, from paired t-test. For open-label period results include unadjusted mean changes and standard errors, no covariate adjustments were applied.||||<0.001
72528969|NCT01258738|144587842|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.93||||0.0091|TWO_SIDED|95.0|-1.62|-0.23|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12||-0.23|-1.62|0.0091
72528970|NCT01258738|144587842|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.79||||0.0097|TWO_SIDED|95.0|-1.38|-0.19|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2||-0.19|-1.38|0.0097
72528971|NCT01258738|144587842|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.82||||0.0101|TWO_SIDED|95.0|-1.45|-0.2|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4||-0.20|-1.45|0.0101
72528972|NCT01258738|144587842|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.97||||0.0031|TWO_SIDED|95.0|-1.61|-0.33|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8||-0.33|-1.61|0.0031
72528973|NCT01258738|144587843|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||All within group comparisons to baseline were \<0.001, from paired t-test. For open-label period results include unadjusted mean changes and standard errors, no covariate adjustments were applied.||||<0.001
72528974|NCT01258738|144587843|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.87||||0.0064|TWO_SIDED|95.0|-1.49|-0.25|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12||-0.25|-1.49|0.0064
72528975|NCT01258738|144587843|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.57||||0.0407|TWO_SIDED|95.0|-1.12|-0.02|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2||-0.02|-1.12|0.0407
72625555|NCT01968980|144780506|SUPERIORITY_OR_OTHER||LS mean difference|-48.0|STANDARD_ERROR_OF_MEAN|2.44|<|0.001|TWO_SIDED|95.0|-52.8|-43.2|||MMRM|||LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region.||-43.2|-52.8|<0.001
72528976|NCT01258738|144587843|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.64||||0.0349|TWO_SIDED|95.0|-1.24|-0.05|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4||-0.05|-1.24|0.0349
72528977|NCT01258738|144587843|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.01||||0.0021|TWO_SIDED|95.0|-1.65|-0.37|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8||-0.37|-1.65|0.0021
72407561|NCT03337724|144323574|SUPERIORITY||Stratified Hazard Ratio|1.08|||||TWO_SIDED|95.0|0.73|1.58|||||Stratification was done prior adjuvant/neoadjuvant chemotherapy (yes vs. no), region, tumor PIK3CA/AKT1/PTEN alteration status (PIK3CA/AKT1-activating mutations vs. PTEN alterations with no PIK3CA/AKT1-activating mutations).|||1.58|0.73|
72407562|NCT03337724|144323574|SUPERIORITY||Stratified Hazard Ratio|0.94|||||TWO_SIDED|95.0|0.65|1.37|||||Stratification variables were: prior adjuvant/neoadjuvant chemotherapy (yes vs. no), region, prior therapy with a PI3K or mTOR inhibitor (yes vs. no).|||1.37|0.65|
72407563|NCT03337724|144323577|SUPERIORITY||Hazard Ratio (HR)|1.36||||0.2162|TWO_SIDED|95.0|0.83|2.22|||Log Rank||Stratification variables were: prior adjuvant/neoadjuvant chemotherapy (yes vs. no), region, prior therapy with a PI3K or mTOR inhibitor (yes vs. no).||Stratified Analysis|2.22|0.83|0.2162
72407564|NCT05569954|144323593|OTHER|Estimated difference in percent and 95% confidence intervals (CI) were based on the Miettinen \& Nurminen method.|Difference in Percent|-1.6|||||TWO_SIDED|95.0|-4.0|0.7|||||V116 minus PPSV23|Injection site erythema: estimated difference in percent||0.7|-4.0|
72407565|NCT05569954|144323593|OTHER|Estimated difference in percent and 95% confidence intervals (CI) were based on the Miettinen \& Nurminen method.|Difference in Percent|3.7|||||TWO_SIDED|95.0|-1.2|8.7|||||V116 minus PPSV23|Injection site pain: estimated difference in percent||8.7|-1.2|
72407566|NCT05569954|144323593|OTHER|Estimated difference in percent and 95% confidence intervals (CI) were based on the Miettinen \& Nurminen method.|Difference in Percent|0.6|||||TWO_SIDED|95.0|-1.6|2.7|||||V116 minus PPSV23|Injection site swelling: estimated difference in percent||2.7|-1.6|
72528978|NCT01258738|144587844|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||All within group comparisons to baseline were \<0.001, from paired t-test. For open-label period results include unadjusted mean changes and standard errors, no covariate adjustments were applied.||||<0.001
72528979|NCT01258738|144587844|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.57||||0.0164|TWO_SIDED|95.0|-1.04|-0.11|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12||-0.11|-1.04|0.0164
72528980|NCT01258738|144587844|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.54||||0.0095|TWO_SIDED|95.0|-0.95|-0.13|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2||-0.13|-0.95|0.0095
72528981|NCT01258738|144587844|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.55||||0.0127|TWO_SIDED|95.0|-0.99|-0.12|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4||-0.12|-0.99|0.0127
72528982|NCT01258738|144587844|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.55||||0.0166|TWO_SIDED|95.0|-0.99|-0.1|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8||-0.10|-0.99|0.0166
72528983|NCT01258738|144587845|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||All within group comparisons to baseline were \<0.001, from paired t-test. For open-label period results include unadjusted mean changes and standard errors, no covariate adjustments were applied.||||<0.001
72528984|NCT01258738|144587845|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.78||||0.0029|TWO_SIDED|95.0|-1.28|-0.27|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2||-0.27|-1.28|0.0029
72528985|NCT01258738|144587845|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.67||||0.0147|TWO_SIDED|95.0|-1.21|-0.13|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4||-0.13|-1.21|0.0147
72407567|NCT05569954|144323594|OTHER|Estimated difference in percent and 95% confidence intervals (CI) were based on the Miettinen \& Nurminen method.|Difference in Percent|0.9|||||TWO_SIDED|95.0|-2.9|4.6|||||V116 minus PPSV23|Fatigue: estimated difference in percent||4.6|-2.9|
72528986|NCT01258738|144587845|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.75||||0.0056|TWO_SIDED|95.0|-1.28|-0.22|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8||-0.22|-1.28|0.0056
72528987|NCT01258738|144587845|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.95||||0.001|TWO_SIDED|95.0|-1.52|-0.39|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12||-0.39|-1.52|0.0010
72528988|NCT01258738|144587846|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||All within group comparisons to baseline were \<0.001, from paired t-test. For open-label period results include unadjusted mean changes and standard errors, no covariate adjustments were applied.||||<0.001
72407568|NCT05569954|144323594|OTHER|Estimated difference in percent and 95% confidence intervals (CI) were based on the Miettinen \& Nurminen method.|Difference in Percent|1.7||||||95.0|-1.8|5.1|||||V116 minus PPSV23|Headache: estimated difference in percent||5.1|-1.8|
72407569|NCT05569954|144323594|OTHER|Estimated difference in percent and 95% confidence intervals (CI) were based on the Miettinen \& Nurminen method.|Difference in Percent|-0.7||||||95.0|-3.1|1.7|||||V116 minus PPSV23|Myalgia: estimated difference in percent||1.7|-3.1|
72407570|NCT05569954|144323594|OTHER|Estimated difference in percent and 95% confidence intervals (CI) were based on the Miettinen \& Nurminen method.|Difference in Percent|-0.3||||||95.0|-1.5|0.9|||||V116 minus PPSV23|Pyrexia: estimated difference in percent||0.9|-1.5|
72407571|NCT05569954|144323595|OTHER|Estimated difference in percent and 95% confidence intervals (CI) were based on the Miettinen \& Nurminen method.|Difference in Percent|0.0||||||95.0|-0.5|0.5|||||V116 minus PPSV23|Vaccine-Related Serious Adverse Events||0.5|-0.5|
72407572|NCT05569954|144323596|NON_INFERIORITY|A conclusion of non-inferiority is based on the lower bound of the 95% CI for the estimated GMT ratio (V116/PPSV23) being \>0.5 (one-sided p-value \<0.025).|GMT Ratio|1.09|||<|0.001|TWO_SIDED|95.0|0.96|1.23||1-sided|cLDA model||V116/PPSV23|Serotype 3: V116/PPSV23 GMT Ratio||1.23|0.96|<0.001
72571746|NCT02912650|144671806|SUPERIORITY_OR_OTHER||LS Mean Difference|1.63|||<|0.001|TWO_SIDED|95.0|1.02|2.23|||ANCOVA|||3 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||2.23|1.02|<0.001
72625556|NCT01968980|144780507|SUPERIORITY_OR_OTHER||LS mean difference|-28.6|STANDARD_ERROR_OF_MEAN|2.73|<|0.001|TWO_SIDED|95.0|-33.9|-23.2|||MMRM|||LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region.||-23.2|-33.9|<0.001
72528989|NCT01258738|144587846|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.65||||0.0173|TWO_SIDED|95.0|-1.19|-0.12|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2||-0.12|-1.19|0.0173
72528990|NCT01258738|144587846|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4||||0.1618|TWO_SIDED|95.0|-0.97|0.16|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4||0.16|-0.97|0.1618
72528991|NCT01258738|144587846|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.69||||0.0153|TWO_SIDED|95.0|-1.25|-0.13|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8||-0.13|-1.25|0.0153
72528992|NCT01258738|144587846|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.49||||0.0866|TWO_SIDED|95.0|-1.05|0.07|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12||0.07|-1.05|0.0866
72528993|NCT01258738|144587847|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||All within group comparisons to baseline were \<0.001, from paired t-test. For open-label period results include unadjusted mean changes and standard errors, no covariate adjustments were applied.||||<0.001
72528994|NCT01258738|144587847|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.41||||0.1413|TWO_SIDED|95.0|-0.95|0.14|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2||0.14|-0.95|0.1413
72528995|NCT01258738|144587847|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6||||0.0284|TWO_SIDED|95.0|-1.14|-0.06|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4||-0.06|-1.14|0.0284
72528996|NCT01258738|144587847|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.52||||0.0659|TWO_SIDED|95.0|-1.07|0.03|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8||0.03|-1.07|0.0659
72528997|NCT01258738|144587847|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.72||||0.0098|TWO_SIDED|95.0|-1.26|-0.18|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12||-0.18|-1.26|0.0098
72528998|NCT01258738|144587848|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||All within group comparisons to baseline were \<0.001, from paired t-test. For open-label period results include unadjusted mean changes and standard errors, no covariate adjustments were applied.||||<0.001
72528999|NCT01258738|144587848|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.75||||0.0037|TWO_SIDED|95.0|-1.26|-0.25|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2||-0.25|-1.26|0.0037
72529000|NCT01258738|144587848|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8||||0.0044|TWO_SIDED|95.0|-1.35|-0.25|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4||-0.25|-1.35|0.0044
72529001|NCT01258738|144587848|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.71||||0.0104|TWO_SIDED|95.0|-1.26|-0.17|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8||-0.17|-1.26|0.0104
72529002|NCT01258738|144587848|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.78||||0.006|TWO_SIDED|95.0|-1.33|-0.22|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12||-0.22|-1.33|0.0060
72529003|NCT01258738|144587849|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||All within group comparisons to baseline were \<0.001, from paired t-test. For open-label period results include unadjusted mean changes and standard errors, no covariate adjustments were applied.||||<0.001
72529004|NCT01258738|144587849|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3||||0.2268|TWO_SIDED|95.0|-0.8|0.19|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2||0.19|-0.80|0.2268
72571747|NCT02912650|144671806|SUPERIORITY_OR_OTHER||LS Mean Difference|4.53|||<|0.001|TWO_SIDED|95.0|3.65|5.4|||ANCOVA|||4 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||5.40|3.65|<0.001
72571748|NCT02912650|144671806|SUPERIORITY_OR_OTHER||LS Mean Difference|0.82||||0.009|TWO_SIDED|95.0|0.21|1.43|||ANCOVA|||4 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||1.43|0.21|0.009
72529005|NCT01258738|144587849|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.42||||0.1145|TWO_SIDED|95.0|-0.93|0.1|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4||0.10|-0.93|0.1145
72529006|NCT01258738|144587849|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5||||0.0512|TWO_SIDED|95.0|-1.0|0.0|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8||0.00|-1.00|0.0512
72529007|NCT01258738|144587849|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.51||||0.0509|TWO_SIDED|95.0|-1.02|0.0|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12||0.00|-1.02|0.0509
72529008|NCT01258738|144587850|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||All within group comparisons to baseline were \<0.001, from paired t-test. For open-label period results include unadjusted mean changes and standard errors, no covariate adjustments were applied.||||<0.001
72529009|NCT01258738|144587850|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.29||||0.243|TWO_SIDED|95.0|-0.79|0.2|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2||0.20|-0.79|0.2430
72529010|NCT01258738|144587850|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.56||||0.0384|TWO_SIDED|95.0|-1.09|-0.03|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4||-0.03|-1.09|0.0384
72529011|NCT01258738|144587850|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.48||||0.0797|TWO_SIDED|95.0|-1.03|0.06|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8||0.06|-1.03|0.0797
72529012|NCT01258738|144587850|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.35||||0.2186|TWO_SIDED|95.0|-0.9|0.21|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12||0.21|-0.90|0.2186
72529013|NCT01258738|144587851|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||All within group comparisons to baseline were \<0.001, from paired t-test. For open-label period results include unadjusted mean changes and standard errors, no covariate adjustments were applied.||||<0.001
72407573|NCT05569954|144323596|NON_INFERIORITY|A conclusion of non-inferiority is based on the lower bound of the 95% CI for the estimated GMT ratio (V116/PPSV23) being \>0.5 (one-sided p-value \<0.025).|GMT Ratio|1.47|||<|0.001|TWO_SIDED|95.0|1.29|1.68||1-sided|cLDA model||V116/PPSV23|Serotype 7F: V116/PPSV23 GMT Ratio||1.68|1.29|<0.001
72529014|NCT01258738|144587851|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.41||||0.141|TWO_SIDED|95.0|-0.96|0.14|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2||0.14|-0.96|0.1410
72529015|NCT01258738|144587851|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.33||||0.2299|TWO_SIDED|95.0|-0.88|0.21|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4||0.21|-0.88|0.2299
72529016|NCT01258738|144587851|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.29||||0.3221|TWO_SIDED|95.0|-0.87|0.29|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8||0.29|-0.87|0.3221
72529017|NCT01258738|144587851|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4||||0.1891|TWO_SIDED|95.0|-0.99|0.2|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12||0.20|-0.99|0.1891
72529018|NCT01258738|144587852|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||All within group comparisons to baseline were \<0.001, from paired t-test. For open-label period results include unadjusted mean changes and standard errors, no covariate adjustments were applied.||||<0.001
72529019|NCT01258738|144587852|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4||||0.108|TWO_SIDED|95.0|-0.9|0.09|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2||0.09|-0.90|0.1080
72529020|NCT01258738|144587852|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.54||||0.0389|TWO_SIDED|95.0|-1.06|-0.03|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4||-0.03|-1.06|0.0389
72529021|NCT01258738|144587852|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.44||||0.1181|TWO_SIDED|95.0|-0.98|0.11|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8||0.11|-0.98|0.1181
72529022|NCT01258738|144587852|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.36||||0.2271|TWO_SIDED|95.0|-0.94|0.22|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12||0.22|-0.94|0.2271
72529023|NCT01258738|144587853|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||All within group comparisons to baseline were \<0.001, from paired t-test. For open-label period results include unadjusted mean changes and standard errors, no covariate adjustments were applied.||||<0.001
72529024|NCT01258738|144587853|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.75||||0.0044|TWO_SIDED|95.0|-1.27|-0.24|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2||-0.24|-1.27|0.0044
72529025|NCT01258738|144587853|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.55||||0.0455|TWO_SIDED|95.0|-1.09|-0.01|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4||-0.01|-1.09|0.0455
72529026|NCT01258738|144587853|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.37||||0.175|TWO_SIDED|95.0|-0.91|0.17|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8||0.17|-0.91|0.1750
72529027|NCT01258738|144587853|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.58||||0.0379|TWO_SIDED|95.0|-1.12|-0.03|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12||-0.03|-1.12|0.0379
72529028|NCT01258738|144587854|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||All within group comparisons to baseline were \<0.001, from paired t-test. For open-label period results include unadjusted mean changes and standard errors, no covariate adjustments were applied.||||<0.001
72529029|NCT01258738|144587854|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.46||||0.0826|TWO_SIDED|95.0|-0.98|0.06|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2||0.06|-0.98|0.0826
72529030|NCT01258738|144587854|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4||||0.1538|TWO_SIDED|95.0|-0.96|0.15|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4||0.15|-0.96|0.1538
72529031|NCT01258738|144587854|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5||||0.0728|TWO_SIDED|95.0|-1.04|0.05|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8||0.05|-1.04|0.0728
72529032|NCT01258738|144587854|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.45||||0.0975|TWO_SIDED|95.0|-0.99|0.08|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12||0.08|-0.99|0.0975
72529033|NCT01258738|144587855|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||All within group comparisons to baseline were \<0.001, from paired t-test. For open-label period results include unadjusted mean changes and standard errors, no covariate adjustments were applied.||||<0.001
72529034|NCT01258738|144587855|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.65||||0.0186|TWO_SIDED|95.0|-1.18|-0.11|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12||-0.11|-1.18|0.0186
72529035|NCT01258738|144587855|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.57||||0.0106|TWO_SIDED|95.0|-1.01|-0.13|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2||-0.13|-1.01|0.0106
72529036|NCT01258738|144587855|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.66||||0.0048|TWO_SIDED|95.0|-1.11|-0.2|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4||-0.20|-1.11|0.0048
72529037|NCT01258738|144587855|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.81||||0.0016|TWO_SIDED|95.0|-1.31|-0.31|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8||-0.31|-1.31|0.0016
72529038|NCT01258738|144587856|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||All within group comparisons to baseline were \<0.001, from paired t-test. For open-label period results include unadjusted mean changes and standard errors, no covariate adjustments were applied.||||<0.001
72529039|NCT01258738|144587856|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8||||0.0058|TWO_SIDED|95.0|-1.37|-0.24|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2||-0.24|-1.37|0.0058
72529040|NCT01258738|144587856|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.83||||0.0064|TWO_SIDED|95.0|-1.42|-0.24|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4||-0.24|-1.42|0.0064
72529041|NCT01258738|144587856|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.23||||0.0002|TWO_SIDED|95.0|-1.85|-0.6|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8||-0.60|-1.85|0.0002
72529042|NCT01258738|144587856|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.83||||0.0134|TWO_SIDED|95.0|-1.49|-0.17|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12||-0.17|-1.49|0.0134
72529043|NCT01258738|144587857|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||All within group comparisons to baseline were \<0.001, from paired t-test. For open-label period results include unadjusted mean changes and standard errors, no covariate adjustments were applied.||||<0.001
72529044|NCT01258738|144587857|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.57||||0.0316|TWO_SIDED|95.0|-1.09|-0.05|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2||-0.05|-1.09|0.0316
72529045|NCT01258738|144587857|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.45||||0.0973|TWO_SIDED|95.0|-0.99|0.08|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4||0.08|-0.99|0.0973
72529046|NCT01258738|144587857|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.68||||0.0216|TWO_SIDED|95.0|-1.27|-0.1|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8||-0.10|-1.27|0.0216
72529047|NCT01258738|144587857|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.39||||0.2425|TWO_SIDED|95.0|-1.03|0.26|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12||0.26|-1.03|0.2425
72529048|NCT01258738|144587858|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||All within group comparisons to baseline were \<0.001, from paired t-test. For open-label period results include unadjusted mean changes and standard errors, no covariate adjustments were applied.||||<0.001
72529049|NCT01258738|144587858|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.33||||0.2688|TWO_SIDED|95.0|-0.92|0.26|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2||0.26|-0.92|0.2688
72529050|NCT01258738|144587858|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.54||||0.0866|TWO_SIDED|95.0|-1.17|0.08|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4||0.08|-1.17|0.0866
72529051|NCT01258738|144587858|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.71||||0.0277|TWO_SIDED|95.0|-1.34|-0.08|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8||-0.08|-1.34|0.0277
72529052|NCT01258738|144587858|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.39||||0.239|TWO_SIDED|95.0|-1.04|0.26|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12||0.26|-1.04|0.2390
72529053|NCT01258738|144587859|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||All within group comparisons to baseline were \<0.001, from paired t-test. For open-label period results include unadjusted mean changes and standard errors, no covariate adjustments were applied.||||<0.001
72529054|NCT01258738|144587859|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.46||||0.0928|TWO_SIDED|95.0|-1.0|0.08|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2||0.08|-1.00|0.0928
72571749|NCT02912650|144671806|SUPERIORITY_OR_OTHER||LS Mean Difference|2.42|||<|0.001|TWO_SIDED|95.0|1.79|3.04|||ANCOVA|||4 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||3.04|1.79|<0.001
72529055|NCT01258738|144587859|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.71||||0.0139|TWO_SIDED|95.0|-1.27|-0.15|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4||-0.15|-1.27|0.0139
72529056|NCT01258738|144587859|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.94||||0.0017|TWO_SIDED|95.0|-1.53|-0.36|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8||-0.36|-1.53|0.0017
72529057|NCT01258738|144587859|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.02||||0.0008|TWO_SIDED|95.0|-1.61|-0.43|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12||-0.43|-1.61|0.0008
72529058|NCT01258738|144587860|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||All within group comparisons to baseline were \<0.001, from paired t-test. For open-label period results include unadjusted mean changes and standard errors, no covariate adjustments were applied.||||<0.001
72529059|NCT01258738|144587860|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.23||||0.4559|TWO_SIDED|95.0|-0.84|0.38|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2||0.38|-0.84|0.4559
72529060|NCT01258738|144587860|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.66||||0.0345|TWO_SIDED|95.0|-1.28|-0.05|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4||-0.05|-1.28|0.0345
72529061|NCT01258738|144587860|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.68||||0.034|TWO_SIDED|95.0|-1.3|-0.05|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8||-0.05|-1.30|0.0340
72529062|NCT01258738|144587860|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6||||0.0634|TWO_SIDED|95.0|-1.24|0.03|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12||0.03|-1.24|0.0634
72529063|NCT01258738|144587861|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||All within group comparisons to baseline were \<0.001, from paired t-test. For open-label period results include unadjusted mean changes and standard errors, no covariate adjustments were applied.||||<0.001
72571750|NCT02912650|144671806|SUPERIORITY_OR_OTHER||LS Mean Difference|3.71|||<|0.001|TWO_SIDED|95.0|2.83|4.58|||ANCOVA|||4 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||4.58|2.83|<0.001
72571751|NCT02912650|144671806|SUPERIORITY_OR_OTHER||LS Mean Difference|2.11|||<|0.001|TWO_SIDED|95.0|1.23|2.99|||ANCOVA|||4 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||2.99|1.23|<0.001
72407574|NCT05569954|144323596|NON_INFERIORITY|A conclusion of non-inferiority is based on the lower bound of the 95% CI for the estimated GMT ratio (V116/PPSV23) being \>0.5 (one-sided p-value \<0.025).|GMT Ratio|1.17|||<|0.001|TWO_SIDED|95.0|1.04|1.32||1-sided|cLDA model||V116/PPSV23|Serotype 8: V116/PPSV23 GMT Ratio||1.32|1.04|<0.001
72407575|NCT05569954|144323596|NON_INFERIORITY|A conclusion of non-inferiority is based on the lower bound of the 95% CI for the estimated GMT ratio (V116/PPSV23) being \>0.5 (one-sided p-value \<0.025).|GMT Ratio|1.12|||<|0.001||95.0|1.0|1.26||1-sided|cLDA model||V116/PPSV23|Serotype 9N: V116/PPSV23 GMT Ratio||1.26|1.00|<0.001
72407576|NCT05569954|144323596|NON_INFERIORITY|A conclusion of non-inferiority is based on the lower bound of the 95% CI for the estimated GMT ratio (V116/PPSV23) being \>0.5 (one-sided p-value \<0.025).|GMT Ratio|1.55|||<|0.001|TWO_SIDED|95.0|1.37|1.77|||cLDA model||V116/PPSV23|Serotype 10A: V116/PPSV23 GMT Ratio||1.77|1.37|<0.001
72529064|NCT01258738|144587861|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0||||0.0007|TWO_SIDED|95.0|-1.56|-0.43|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2||-0.43|-1.56|0.0007
72529065|NCT01258738|144587861|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.81||||0.0073|TWO_SIDED|95.0|-1.39|-0.22|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4||-0.22|-1.39|0.0073
72529066|NCT01258738|144587861|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.85||||0.0094|TWO_SIDED|95.0|-1.48|-0.21|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8||-0.21|-1.48|0.0094
72529067|NCT01258738|144587861|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.87||||0.012|TWO_SIDED|95.0|-1.54|-0.19|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12||-0.19|-1.54|0.0120
72529068|NCT01258738|144587862|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|19.96||||0.0029|TWO_SIDED|95.0|7.54|32.37|||Cochran-Mantel-Haenszel|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12||32.37|7.54|0.0029
72529069|NCT01258738|144587862|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.59||||0.01|TWO_SIDED|95.0|3.18|19.99|||Cochran-Mantel-Haenszel|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2||19.99|3.18|0.0100
72529070|NCT01258738|144587862|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.75||||0.012|TWO_SIDED|95.0|3.62|23.89|||Cochran-Mantel-Haenszel|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4||23.89|3.62|0.0120
72529071|NCT01258738|144587862|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|15.12||||0.0213|TWO_SIDED|95.0|3.04|27.2|||Cochran-Mantel-Haenszel|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8||27.20|3.04|0.0213
72529072|NCT01258738|144587863|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.88||||0.2755|TWO_SIDED|95.0|-5.15|20.92|||Cochran-Mantel-Haenszel|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12||20.92|-5.15|0.2755
72407577|NCT05569954|144323596|NON_INFERIORITY|A conclusion of non-inferiority is based on the lower bound of the 95% CI for the estimated GMT ratio (V116/PPSV23) being \>0.5 (one-sided p-value \<0.025).|GMT Ratio|2.05|||<|0.001||95.0|1.82|2.31|||cLDA model||V116/PPSV23|Serotype 11A: V116/PPSV23 GMT Ratio||2.31|1.82|<0.001
72529073|NCT01258738|144587863|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.57||||0.195|TWO_SIDED|95.0|-4.39|21.54|||Cochran-Mantel-Haenszel|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2||21.54|-4.39|0.1950
72529074|NCT01258738|144587863|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.99||||0.0278|TWO_SIDED|95.0|0.72|27.26|||Cochran-Mantel-Haenszel|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4||27.26|0.72|0.0278
72529075|NCT01258738|144587863|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|15.29||||0.0174|TWO_SIDED|95.0|2.28|28.3|||Cochran-Mantel-Haenszel|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8||28.30|2.28|0.0174
72529076|NCT01258738|144587864|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||All within group comparisons to baseline were \<0.001, from paired t-test. For open-label period results include unadjusted mean changes and standard errors, no covariate adjustments were applied.||||<0.001
72529077|NCT01258738|144587864|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.54||||0.0201|TWO_SIDED|95.0|-0.99|-0.09|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 4 and 12 data only. Week 4||-0.09|-0.99|0.0201
72529078|NCT01258738|144587864|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5||||0.0558|TWO_SIDED|95.0|-1.02|0.01|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 4 and 12 data only. Week 12||0.01|-1.02|0.0558
72529079|NCT01258738|144587865|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||All within group comparisons to baseline were \<0.001, from paired t-test, after Week 24. For label period results include unadjusted mean changes and standard errors, no covariate adjustments were applied.||||<0.001
72407578|NCT05569954|144323596|NON_INFERIORITY|A conclusion of non-inferiority is based on the lower bound of the 95% CI for the estimated GMT ratio (V116/PPSV23) being \>0.5 (one-sided p-value \<0.025).|GMT Ratio|1.63|||<|0.001|TWO_SIDED|95.0|1.4|1.9|||cLDA model||V116/PPSV23|Serotype 12F: V116/PPSV23 GMT Ratio||1.90|1.40|<0.001
72529080|NCT01258738|144587865|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.05||||0.6741|TWO_SIDED|95.0|-0.18|0.28|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2||0.28|-0.18|0.6741
72529081|NCT01258738|144587865|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.3896|TWO_SIDED|95.0|-0.33|0.13|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4||0.13|-0.33|0.3896
72529082|NCT01258738|144587865|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.04||||0.7468|TWO_SIDED|95.0|-0.22|0.31|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8||0.31|-0.22|0.7468
72529083|NCT01258738|144587865|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.06||||0.6871|TWO_SIDED|95.0|-0.35|0.23|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12||0.23|-0.35|0.6871
72529084|NCT01258738|144587866|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||All within group comparisons to baseline were \<0.001, from paired t-test, after Week 24. For label period results include unadjusted mean changes and standard errors, no covariate adjustments were applied.||||<0.001
72529085|NCT01258738|144587866|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.37||||0.4332|TWO_SIDED|95.0|-0.57|1.32|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2||1.32|-0.57|0.4332
72529086|NCT01258738|144587866|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.9947|TWO_SIDED|95.0|-0.98|0.98|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4||0.98|-0.98|0.9947
72529087|NCT01258738|144587866|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.74||||0.1558|TWO_SIDED|95.0|-0.28|1.75|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8||1.75|-0.28|0.1558
72529088|NCT01258738|144587866|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.21||||0.0488|TWO_SIDED|95.0|0.03|2.39|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12||2.39|0.03|0.0488
72529089|NCT01258738|144587867|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||All within group comparisons to baseline were \<0.001, from paired t-test, after Week 24. For label period results include unadjusted mean changes and standard errors, no covariate adjustments were applied.||||<0.001
72529090|NCT01258738|144587867|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.37||||0.7645|TWO_SIDED|95.0|-2.06|2.8|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2||2.80|-2.06|0.7645
72529091|NCT01258738|144587867|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.03||||0.4178|TWO_SIDED|95.0|-1.48|3.55|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4||3.55|-1.48|0.4178
72625557|NCT01968980|144780508|SUPERIORITY_OR_OTHER||LS mean difference|7.0|STANDARD_ERROR_OF_MEAN|1.47|<|0.001|TWO_SIDED|95.0|4.1|9.9|||MMRM|||LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region.||9.9|4.1|<0.001
72529092|NCT01258738|144587867|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.06||||0.443|TWO_SIDED|95.0|-1.67|3.79|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8||3.79|-1.67|0.4430
72529093|NCT01258738|144587867|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.39||||0.1095|TWO_SIDED|95.0|-0.54|5.31|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12||5.31|-0.54|0.1095
72529094|NCT01258738|144587868|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||All within group comparisons to baseline were \<0.001, from paired t-test, after Week 24. For label period results include unadjusted mean changes and standard errors, no covariate adjustments were applied.||||<0.001
72529095|NCT01258738|144587868|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01||||0.9504|TWO_SIDED|95.0|-0.46|0.49|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2||0.49|-0.46|0.9504
72529096|NCT01258738|144587868|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.18||||0.4971|TWO_SIDED|95.0|-0.7|0.34|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4||0.34|-0.70|0.4971
72529097|NCT01258738|144587868|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.03||||0.8999|TWO_SIDED|95.0|-0.47|0.54|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8||0.54|-0.47|0.8999
72529098|NCT01258738|144587868|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01||||0.9712|TWO_SIDED|95.0|-0.6|0.62|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12||0.62|-0.60|0.9712
72529099|NCT01258738|144587869|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||All within group comparisons to baseline were \<0.001, from paired t-test, after Week 24. For label period results include unadjusted mean changes and standard errors, no covariate adjustments were applied.||||<0.001
72529100|NCT01258738|144587869|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.89||||0.4556|TWO_SIDED|95.0|-1.46|3.24|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2||3.24|-1.46|0.4556
72529101|NCT01258738|144587869|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.85||||0.0543|TWO_SIDED|95.0|-0.05|5.75|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4||5.75|-0.05|0.0543
72529102|NCT01258738|144587869|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.26||||0.1754|TWO_SIDED|95.0|-1.02|5.53|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8||5.53|-1.02|0.1754
72529103|NCT01258738|144587869|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.45||||0.3985|TWO_SIDED|95.0|-1.93|4.82|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12||4.82|-1.93|0.3985
72529104|NCT01258738|144587870|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||All within group comparisons to baseline were \<0.001, from paired t-test, after Week 24. For label period results include unadjusted mean changes and standard errors, no covariate adjustments were applied.||||<0.001
72529105|NCT01258738|144587870|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.22||||0.2823|TWO_SIDED|95.0|-0.18|0.62|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2||0.62|-0.18|0.2823
72529106|NCT01258738|144587870|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.17||||0.4029|TWO_SIDED|95.0|-0.23|0.58|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4||0.58|-0.23|0.4029
72529107|NCT01258738|144587870|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.13||||0.511|TWO_SIDED|95.0|-0.25|0.51|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8||0.51|-0.25|0.5110
72571752|NCT02912650|144671806|SUPERIORITY_OR_OTHER||LS Mean Difference|1.6|||<|0.001|TWO_SIDED|95.0|0.97|2.22|||ANCOVA|||4 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||2.22|0.97|<0.001
72407579|NCT05569954|144323596|NON_INFERIORITY|A conclusion of non-inferiority is based on the lower bound of the 95% CI for the estimated GMT ratio (V116/PPSV23) being \>0.5 (one-sided p-value \<0.025).|GMT Ratio|2.02|||<|0.001|TWO_SIDED|95.0|1.77|2.31|||cLDA model||V116/PPSV23|Serotype 17F: V116/PPSV23GMT Ratio||2.31|1.77|<0.001
72529108|NCT01258738|144587870|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.12||||0.5844|TWO_SIDED|95.0|-0.32|0.56|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12||0.56|-0.32|0.5844
72529109|NCT01258738|144587871|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||Most within group comparisons to baseline were \<0.001, from paired t-test. For open-label period results include unadjusted mean changes and standard errors, no covariate adjustments were applied.||||<0.001
72529110|NCT01258738|144587871|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.53||||0.0129|TWO_SIDED|95.0|-0.95|-0.11|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2||-0.11|-0.95|0.0129
72529111|NCT01258738|144587871|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.13||||0.6003|TWO_SIDED|95.0|-0.61|0.35|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4||0.35|-0.61|0.6003
72529112|NCT01258738|144587871|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.41||||0.0911|TWO_SIDED|95.0|-0.89|0.07|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8||0.07|-0.89|0.0911
72529113|NCT01258738|144587871|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.25||||0.3144|TWO_SIDED|95.0|-0.73|0.24|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12||0.24|-0.73|0.3144
72571753|NCT02912650|144671806|SUPERIORITY_OR_OTHER||LS Mean Difference|4.27|||<|0.001|TWO_SIDED|95.0|3.37|5.17|||ANCOVA|||5 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||5.17|3.37|<0.001
72529114|NCT01258738|144587872|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||Most within group comparisons to baseline were \<0.001, from paired t-test. For open-label period results include unadjusted mean changes and standard errors, no covariate adjustments were applied.||||<0.001
72571754|NCT02912650|144671806|SUPERIORITY_OR_OTHER||LS Mean Difference|0.81||||0.012|TWO_SIDED|95.0|0.18|1.44|||ANCOVA|||5 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||1.44|0.18|0.012
72407580|NCT05569954|144323596|NON_INFERIORITY|A conclusion of non-inferiority is based on the lower bound of the 95% CI for the estimated GMT ratio (V116/PPSV23) being \>0.5 (one-sided p-value \<0.025).|GMT Ratio|1.42|||<|0.001|TWO_SIDED|95.0|1.26|1.6|||cLDA model||V116/PPSV23|Serotype 19A: V116/PPSV23 GMT Ratio||1.60|1.26|<0.001
72407581|NCT05569954|144323596|NON_INFERIORITY|A conclusion of non-inferiority is based on the lower bound of the 95% CI for the estimated GMT ratio (V116/PPSV23) being \>0.5 (one-sided p-value \<0.025).|GMT Ratio|1.66|||<|0.001|TWO_SIDED|95.0|1.46|1.88|||cLDA model||V116/PPSV23|Serotype 20A: V116/PPSV23 GMT Ratio||1.88|1.46|<0.001
72407582|NCT05569954|144323596|NON_INFERIORITY|A conclusion of non-inferiority is based on the lower bound of the 95% CI for the estimated GMT ratio (V116/PPSV23) being \>0.5 (one-sided p-value \<0.025).|GMT Ratio|1.53|||<|0.001|TWO_SIDED|95.0|1.34|1.75|||cLDA model||V116/PPSV23|Serotype 22F: V116/PPSV23 GMT Ratio||1.75|1.34|<0.001
72407583|NCT05569954|144323596|NON_INFERIORITY|A conclusion of non-inferiority is based on the lower bound of the 95% CI for the estimated GMT ratio (V116/PPSV23) being \>0.5 (one-sided p-value \<0.025).|GMT Ratio|0.89|||<|0.001|TWO_SIDED|95.0|0.76|1.04|||cLDA model||V116/PPSV23|Serotype 33F: V116/PPSV23 GMT Ratio||1.04|0.76|<0.001
72529115|NCT01258738|144587872|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.09||||0.6476|TWO_SIDED|95.0|-0.46|0.29|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12, data only. Week 2||0.29|-0.46|0.6476
72571755|NCT02912650|144671806|SUPERIORITY_OR_OTHER||LS Mean Difference|2.36|||<|0.001|TWO_SIDED|95.0|1.72|3.0|||ANCOVA|||5 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||3.00|1.72|<0.001
72571756|NCT02912650|144671806|SUPERIORITY_OR_OTHER||LS Mean Difference|3.47|||<|0.001|TWO_SIDED|95.0|2.57|4.36|||ANCOVA|||5 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||4.36|2.57|<0.001
72407584|NCT05569954|144323596|SUPERIORITY|A conclusion of superiority is based on the lower bound of the 95% CI for the estimated GMT ratio (V116/PPSV23) being \>2.0 (one-sided p-value \<0.025).|GMT Ratio|3.31|||<|0.001|TWO_SIDED|95.0|2.84|3.87||1-sided|cLDA model||V116/PPSV23|Serotype 6A: V116/PPSV23 GMT Ratio||3.87|2.84|<0.001
72407585|NCT05569954|144323596|SUPERIORITY|A conclusion of superiority is based on the lower bound of the 95% CI for the estimated GMT ratio (V116/PPSV23) being \>2.0 (one-sided p-value \<0.025).|GMT Ratio|4.61|||<|0.001|TWO_SIDED|95.0|3.99|5.33||1-sided|cLDA model||V116/PPSV23|Serotype 15A: V116/PPSV23 GMT Ratio||5.33|3.99|<0.001
72407586|NCT05569954|144323596|SUPERIORITY|A conclusion of superiority is based on the lower bound of the 95% CI for the estimated GMT ratio (V116/PPSV23) being \>2.0 (one-sided p-value \<0.025).|GMT Ratio|2.92|||<|0.001||95.0|2.5|3.42||1-sided|cLDA model||V116/PPSV23|Serotype 15C: V116/PPSV23 GMT Ratio||3.42|2.50|<0.001
72407587|NCT05569954|144323596|SUPERIORITY|A conclusion of superiority is based on the lower bound of the 95% CI for the estimated GMT ratio (V116/PPSV23) being \>2.0 (one-sided p-value \<0.025).|GMT Ratio|4.5|||<|0.001|TWO_SIDED|95.0|3.99|5.09||1-sided|cLDA model||V116/PPSV23|Serotype 16F: V116/PPSV23 GMT Ratio||5.09|3.99|<0.001
72529116|NCT01258738|144587872|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01||||0.9777|TWO_SIDED|95.0|-0.4|0.39|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12, data only. Week 4||0.39|-0.40|0.9777
72407588|NCT05569954|144323596|SUPERIORITY|A conclusion of superiority is based on the lower bound of the 95% CI for the estimated GMT ratio (V116/PPSV23) being \>2.0 (one-sided p-value \<0.025).|GMT Ratio|5.74|||<|0.001|TWO_SIDED|95.0|4.81|6.85||1-sided|cLDA model||V116/PPSV23|Serotype 23A: V116/PPSV23 GMT Ratio||6.85|4.81|<0.001
72407589|NCT05569954|144323596|SUPERIORITY|A conclusion of superiority is based on the lower bound of the 95% CI for the estimated GMT ratio (V116/PPSV23) being \>2.0 (one-sided p-value \<0.025).|GMT Ratio|16.42|||<|0.001|TWO_SIDED|95.0|13.46|20.03||1-sided|cLDA model||V116/PPSV23|Serotype 23B: V116/PPSV23 GMT Ratio||20.03|13.46|<0.001
72407590|NCT05569954|144323596|SUPERIORITY|A conclusion of superiority is based on the lower bound of the 95% CI for the estimated GMT ratio (V116/PPSV23) being \>2.0 (one-sided p-value \<0.025).|GMT Ratio|3.39|||<|0.001||95.0|2.97|3.87||1-sided|cLDA model||V116/PPSV23|Serotype 24F: V116/PPSV23 GMT Ratio||3.87|2.97|<0.001
72407591|NCT05569954|144323596|SUPERIORITY|A conclusion of superiority is based on the lower bound of the 95% CI for the estimated GMT ratio (V116/PPSV23) being \>2.0 (one-sided p-value \<0.025).|GMT Ratio|11.89|||<|0.001|TWO_SIDED|95.0|10.16|13.91||1-sided|cLDA model||V116/PPSV23|Serotype 31: V116/PPSV23 GMT Ratio||13.91|10.16|<0.001
72529117|NCT01258738|144587872|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.18||||0.4453|TWO_SIDED|95.0|-0.28|0.65|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12, data only. Week 8||0.65|-0.28|0.4453
72571757|NCT02912650|144671806|SUPERIORITY_OR_OTHER||LS Mean Difference|1.91|||<|0.001|TWO_SIDED|95.0|1.0|2.82|||ANCOVA|||5 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||2.82|1.00|<0.001
72571758|NCT02912650|144671806|SUPERIORITY_OR_OTHER||LS Mean Difference|1.55|||<|0.001|TWO_SIDED|95.0|0.92|2.19|||ANCOVA|||5 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||2.19|0.92|<0.001
72571759|NCT02912650|144671806|SUPERIORITY_OR_OTHER||LS Mean Difference|3.68|||<|0.001|TWO_SIDED|95.0|2.76|4.6|||ANCOVA|||6 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||4.60|2.76|<0.001
72571760|NCT02912650|144671806|SUPERIORITY_OR_OTHER||LS Mean Difference|0.63||||0.055|TWO_SIDED|95.0|-0.01|1.27|||ANCOVA|||6 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||1.27|-0.01|0.055
72529118|NCT01258738|144587872|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.13||||0.5782|TWO_SIDED|95.0|-0.33|0.6|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12, data only. Week 12||0.60|-0.33|0.5782
72571761|NCT02912650|144671806|SUPERIORITY_OR_OTHER||LS Mean Difference|2.19|||<|0.001|TWO_SIDED|95.0|1.54|2.84|||ANCOVA|||6 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||2.84|1.54|<0.001
72529119|NCT01258738|144587873|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.96||||0.0414|TWO_SIDED|95.0|-1.88|-0.04|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 12 data only.||-0.04|-1.88|0.0414
72529120|NCT01258738|144587874|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||Within group comparisons to baseline were \<0.001, from paired t-test.||||<0.001
72529121|NCT01258738|144587874|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.93|||<|0.001|TWO_SIDED|95.0|-4.16|-1.7|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 12 data only.||-1.70|-4.16|<0.001
72529122|NCT01258738|144587875|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||Within group comparisons to baseline were \<0.001, from paired t-test.||||<0.001
72529123|NCT01258738|144587875|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.96||||0.0414|TWO_SIDED|95.0|-1.88|-0.04|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 12 data only.||-0.04|-1.88|0.0414
72529124|NCT01258738|144587876|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4||||0.0132|TWO_SIDED|95.0|-0.72|-0.08|||ANCOVA|||"Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made.~Comparative analysis was carried out for Week 12 data only."||-0.08|-0.72|0.0132
72625558|NCT01968980|144780509|SUPERIORITY_OR_OTHER||LS mean difference|-52.1|STANDARD_ERROR_OF_MEAN|3.1|||TWO_SIDED|95.0|-58.2|-46.0||||||Week 24: LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region.||-46.0|-58.2|
72369366|NCT00806819|144248655|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.01||||0.8929|TWO_SIDED|95.0|0.84|1.23|||Regression, Cox||HR below 1 favors nintedanib|Analysis evaluating the time to deterioration of pain. HR, CI and p-value obtained from the prop. hazards model stratified by baseline ECOG PS (0 vs \>= 1), tumour histology (adenocarcinoma vs. non-adenocarcinoma), brain metastases at baseline (yes vs no) and prior treatment with bevacizumab (yes vs no).||1.23|0.84|0.8929
72529125|NCT01258738|144587877|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||Within group comparisons to baseline were \<0.001, from paired t-test.||||<0.001
72529126|NCT01258738|144587877|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.19||||0.2438|TWO_SIDED|95.0|-0.52|0.13|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2||0.13|-0.52|0.2438
72529127|NCT01258738|144587877|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.17||||0.1958|TWO_SIDED|95.0|-0.42|0.09|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4||0.09|-0.42|0.1958
72529128|NCT01258738|144587877|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.19||||0.1624|TWO_SIDED|95.0|-0.46|0.08|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8||0.08|-0.46|0.1624
72529129|NCT01258738|144587877|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.31||||0.0091|TWO_SIDED|95.0|-0.54|-0.08|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12||-0.08|-0.54|0.0091
72529130|NCT01258738|144587878|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||Within group comparisons to baseline were \<0.001, from paired t-test.||||<0.001
72529131|NCT01258738|144587878|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.62||||0.0836|TWO_SIDED|95.0|-1.32|0.08|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2||0.08|-1.32|0.0836
72529132|NCT01258738|144587878|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.24||||0.5402|TWO_SIDED|95.0|-1.02|0.54|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4||0.54|-1.02|0.5402
72529133|NCT01258738|144587878|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.09||||0.8167|TWO_SIDED|95.0|-0.69|0.87|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8||0.87|-0.69|0.8167
72571762|NCT02912650|144671806|SUPERIORITY_OR_OTHER||LS Mean Difference|3.05|||<|0.001|TWO_SIDED|95.0|2.14|3.97|||ANCOVA|||6 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||3.97|2.14|<0.001
72571763|NCT02912650|144671806|SUPERIORITY_OR_OTHER||LS Mean Difference|1.49||||0.002|TWO_SIDED|95.0|0.57|2.42|||ANCOVA|||6 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||2.42|0.57|0.002
72571764|NCT02912650|144671806|SUPERIORITY_OR_OTHER||LS Mean Difference|1.56|||<|0.001|TWO_SIDED|95.0|0.91|2.21|||ANCOVA|||6 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||2.21|0.91|<0.001
72529134|NCT01258738|144587878|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01||||0.9891|TWO_SIDED|95.0|-0.72|0.73|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12||0.73|-0.72|0.9891
72529135|NCT01258738|144587879|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||All within group comparisons to baseline were \<0.001, from paired t-test.||||<0.001
72529136|NCT01258738|144587879|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02||||0.6148|TWO_SIDED|95.0|-0.08|0.05|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2||0.05|-0.08|0.6148
72529137|NCT01258738|144587879|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.04||||0.2547|TWO_SIDED|95.0|-0.11|0.03|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4||0.03|-0.11|0.2547
72529138|NCT01258738|144587879|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.04||||0.1208|TWO_SIDED|95.0|-0.08|0.01|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8||0.01|-0.08|0.1208
72529139|NCT01258738|144587879|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.02||||0.8291|TWO_SIDED|95.0|-0.13|0.17|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12||0.17|-0.13|0.8291
72529140|NCT01258738|144587880|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||All within group comparisons to baseline were \<0.001, from paired t-test.||||<0.001
72529141|NCT01258738|144587880|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.21||||0.3536|TWO_SIDED|95.0|-0.64|0.23|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2||0.23|-0.64|0.3536
72529142|NCT01258738|144587880|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.46||||0.0769|TWO_SIDED|95.0|-0.97|0.05|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4||0.05|-0.97|0.0769
72529143|NCT01258738|144587880|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.19||||0.4698|TWO_SIDED|95.0|-0.7|0.33|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8||0.33|-0.70|0.4698
72625559|NCT01968980|144780509|SUPERIORITY_OR_OTHER||LS mean difference|-48.0|STANDARD_ERROR_OF_MEAN|2.87|||TWO_SIDED|95.0|-53.6|-42.3||||||Week 52: LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region.||-42.3|-53.6|
72529144|NCT01258738|144587880|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.65||||0.0167|TWO_SIDED|95.0|-1.19|-0.12|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12||-0.12|-1.19|0.0167
72369367|NCT04901715|144248690|OTHER|||||||0.002|||||||ANOVA|||||||0.002
72369368|NCT04901715|144248690|OTHER|||||||0.054|||||||ANOVA|||||||0.054
72369369|NCT04901715|144248690|OTHER|||||||0.27|||||||ANOVA|||||||0.27
72529145|NCT01258738|144587881|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||Most within group comparisons to baseline were \<0.001, from paired t-test. For open-label period results include unadjusted mean changes and standard errors, no covariate adjustments were applied.||||<0.001
72529146|NCT01258738|144587881|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.02|||<|0.0001|TWO_SIDED|95.0|-4.39|-1.66|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2||-1.66|-4.39|<0.0001
72529147|NCT01258738|144587881|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.86||||0.0008|TWO_SIDED|95.0|-6.09|-1.62|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4||-1.62|-6.09|0.0008
72529148|NCT01258738|144587881|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.04||||0.0143|TWO_SIDED|95.0|-5.47|-0.61|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8||-0.61|-5.47|0.0143
72529149|NCT01258738|144587881|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.12||||0.0038|TWO_SIDED|95.0|-5.23|-1.02|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12||-1.02|-5.23|0.0038
72529150|NCT01258738|144587882|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||All within group comparisons to baseline were \<0.001, from paired t-test||||<0.001
72529151|NCT01258738|144587882|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.71|||<|0.0001|TWO_SIDED|95.0|-10.85|-4.58|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2||-4.58|-10.85|<0.0001
72529152|NCT01258738|144587882|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.12|||<|0.0001|TWO_SIDED|95.0|-9.16|-3.09|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4||-3.09|-9.16|<0.0001
72369370|NCT04901715|144248691|OTHER|||||||0.014|||||||ANOVA|||||||0.014
72369371|NCT04901715|144248691|OTHER|||||||0.066|||||||ANOVA|||||||0.066
72529153|NCT01258738|144587882|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.78||||0.0009|TWO_SIDED|95.0|-9.15|-2.41|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8||-2.41|-9.15|0.0009
72529154|NCT01258738|144587882|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.03|||<|0.0001|TWO_SIDED|95.0|-10.34|-3.73|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12||-3.73|-10.34|<0.0001
72529155|NCT01258738|144587883|SUPERIORITY_OR_OTHER|||||||0.037|||||||t-test, 2 sided|||With the exception of change from Baseline in the placebo group at Week 12, within group comparisons to baseline for all other treatment groups and time points were \<0.001, from paired t-test.||||0.0370
72529156|NCT01258738|144587883|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01||||0.9965|TWO_SIDED|95.0|-4.39|4.37|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 4, 8, 12 data only. Week 4||4.37|-4.39|0.9965
72529157|NCT01258738|144587883|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.61||||0.197|TWO_SIDED|95.0|-1.89|9.1|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 4, 8, 12 data only. Week 8||9.10|-1.89|0.1970
72529158|NCT01258738|144587883|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.07||||0.0394|TWO_SIDED|95.0|0.3|11.84|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 4, 8, 12 data only. Week 12||11.84|0.30|0.0394
72529159|NCT01258738|144587884|SUPERIORITY_OR_OTHER||||||<|0.01|||||||t-test, 2 sided|||Within group comparisons to baseline were \<0.01 at Week 12 and \<0.001 thereafter, from paired t-test.||||<0.01
72571765|NCT02912650|144671806|SUPERIORITY_OR_OTHER||LS Mean Difference|3.1|||<|0.001|TWO_SIDED|95.0|2.17|4.03|||ANCOVA|||7 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||4.03|2.17|<0.001
72571766|NCT02912650|144671806|SUPERIORITY_OR_OTHER||LS Mean Difference|0.65||||0.049|TWO_SIDED|95.0|0.0|1.3|||ANCOVA|||7 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||1.30|0.00|0.049
72529160|NCT01258738|144587884|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.05||||0.1341|TWO_SIDED|95.0|-0.02|0.21|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 4, 8, 12 data only. Week 4||0.21|-0.02|0.1341
72529161|NCT01258738|144587884|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.07||||0.0447|TWO_SIDED|95.0|0.0|0.14|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 4, 8, 12 data only. Week 8||0.14|0.00|0.0447
72529162|NCT01258738|144587884|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.06||||0.1345|TWO_SIDED|95.0|-0.02|0.13|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 4, 8, 12 data only. Week 12||0.13|-0.02|0.1345
72529163|NCT01258738|144587885|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||Within group comparisons to baseline were \<0.001, from paired t-test.||||<0.001
72529164|NCT01258738|144587885|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.31||||0.1035|TWO_SIDED|95.0|-0.27|2.9|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 4, 12 data only. Week 4||2.90|-0.27|0.1035
72529165|NCT01258738|144587885|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.38||||0.0134|TWO_SIDED|95.0|0.5|4.26|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 4, 12 data only. Week 12||4.26|0.50|0.0134
72529166|NCT01258738|144587886|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||Within group comparisons to baseline were \<0.05, from paired t-test.||||<0.05
72529167|NCT01258738|144587886|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.18||||0.252|TWO_SIDED|95.0|-0.84|3.19|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 4, 12 data only. Week 4||3.19|-0.84|0.2520
72571767|NCT02912650|144671806|SUPERIORITY_OR_OTHER||LS Mean Difference|1.93|||<|0.001|TWO_SIDED|95.0|1.27|2.59|||ANCOVA|||7 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||2.59|1.27|<0.001
72571768|NCT02912650|144671806|SUPERIORITY_OR_OTHER||LS Mean Difference|2.44|||<|0.001|TWO_SIDED|95.0|1.52|3.37|||ANCOVA|||7 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||3.37|1.52|<0.001
72571769|NCT02912650|144671806|SUPERIORITY_OR_OTHER||LS Mean Difference|1.17||||0.015|TWO_SIDED|95.0|0.23|2.1|||ANCOVA|||7 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||2.10|0.23|0.015
72571770|NCT02912650|144671806|SUPERIORITY_OR_OTHER||LS Mean Difference|1.28|||<|0.001|TWO_SIDED|95.0|0.62|1.94|||ANCOVA|||7 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||1.94|0.62|<0.001
72369372|NCT04901715|144248691|OTHER|||||||0.58|||||||ANOVA|||||||0.58
72369373|NCT03843541|144248700|SUPERIORITY||Mean Difference (Net)|-0.24|STANDARD_DEVIATION|0.763|<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||For the superiority comparisons of NAC vs. placebo, the Bonferroni correction was used.||||<0.001
72529168|NCT01258738|144587886|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.85||||0.4981|TWO_SIDED|95.0|-1.63|3.34|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 4, 12 data only. Week 12||3.34|-1.63|0.4981
72529169|NCT01258738|144587887|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||Within group comparisons to baseline were \<0.001, from paired t-test.||||<0.001
72529170|NCT01258738|144587887|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.24||||0.4621|TWO_SIDED|95.0|-0.9|0.41|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 4, 12 data only. Week 4||0.41|-0.90|0.4621
72529171|NCT01258738|144587887|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.39||||0.3842|TWO_SIDED|95.0|-1.28|0.5|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 4, 12 data only. Week 12||0.50|-1.28|0.3842
72529172|NCT01258738|144587888|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||Within group comparisons to baseline were \<0.001, from paired t-test.||||<0.001
72529173|NCT01258738|144587888|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.17||||0.6357|TWO_SIDED|95.0|-0.52|0.86|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 4, 12 data only. Week 4||0.86|-0.52|0.6357
72529174|NCT01258738|144587888|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.52||||0.2439|TWO_SIDED|95.0|-1.39|0.36|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 4, 12 data only. Week 12||0.36|-1.39|0.2439
72529175|NCT01258738|144587889|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||Within group comparisons to baseline were \<0.001, from paired t-test.||||<0.001
72529176|NCT01258738|144587889|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.52||||0.3286|TWO_SIDED|95.0|-1.55|0.52|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Descriptive analysis was carried out for Week 12 data only.||0.52|-1.55|0.3286
72571771|NCT02912650|144671806|SUPERIORITY_OR_OTHER||LS Mean Difference|2.48|||<|0.001|TWO_SIDED|95.0|1.56|3.4|||ANCOVA|||8 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||3.40|1.56|<0.001
72571772|NCT02912650|144671806|SUPERIORITY_OR_OTHER||LS Mean Difference|0.56||||0.087|TWO_SIDED|95.0|-0.08|1.2|||ANCOVA|||8 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||1.20|-0.08|0.087
72529177|NCT01258738|144587890|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||Within group comparisons to baseline were \<0.001, from paired t-test.||||<0.001
72529178|NCT01258738|144587890|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.78||||0.1829|TWO_SIDED|95.0|-1.93|0.37|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 12 data only.||0.37|-1.93|0.1829
72529179|NCT01258738|144587891|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||Within group comparisons to baseline were \<0.05, from paired t-test.||||<0.05
72529180|NCT01258738|144587891|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.37||||0.5226|TWO_SIDED|95.0|-4.95|9.68|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2||9.68|-4.95|0.5226
72529181|NCT01258738|144587891|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.62||||0.6232|TWO_SIDED|95.0|-4.9|8.14|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4||8.14|-4.90|0.6232
72529182|NCT01258738|144587891|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.52||||0.3877|TWO_SIDED|95.0|-4.53|11.57|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8||11.57|-4.53|0.3877
72529183|NCT01258738|144587891|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.74||||0.2402|TWO_SIDED|95.0|-3.22|12.69|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12||12.69|-3.22|0.2402
72529184|NCT01258738|144587892|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||Within group comparisons to baseline were \<0.001 at Week 16 and thereafter, from paired t-test.||||<0.001
72571773|NCT02912650|144671806|SUPERIORITY_OR_OTHER||LS Mean Difference|1.47|||<|0.001|TWO_SIDED|95.0|0.82|2.12|||ANCOVA|||8 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||2.12|0.82|<0.001
72571774|NCT02912650|144671806|SUPERIORITY_OR_OTHER||LS Mean Difference|1.92|||<|0.001|TWO_SIDED|95.0|1.0|2.84|||ANCOVA|||8 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||2.84|1.00|<0.001
72571775|NCT02912650|144671806|SUPERIORITY_OR_OTHER||LS Mean Difference|1.01||||0.032|TWO_SIDED|95.0|0.09|1.94|||ANCOVA|||8 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||1.94|0.09|0.032
72571776|NCT02912650|144671806|SUPERIORITY_OR_OTHER||LS Mean Difference|0.91||||0.006|TWO_SIDED|95.0|0.26|1.56|||ANCOVA|||8 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||1.56|0.26|0.006
72407592|NCT05569954|144323596|SUPERIORITY|A conclusion of superiority is based on the lower bound of the 95% CI for the estimated GMT ratio (V116/PPSV23) being \>2.0 (one-sided p-value \<0.025).|GMT Ratio|6.17|||<|0.001|TWO_SIDED|95.0|5.54|6.87||1-sided|cLDA model||V116/PPSV23|Serotype 35B: V116/PPSV23 GMT Ratio||6.87|5.54|<0.001
72407593|NCT05569954|144323597|SUPERIORITY|A conclusion of superiority is based on the lower bound of the 95% CI for the difference \[V116 - PPSV23\] between the percentages of participants with a ≥4-fold rise from baseline to 30 days postvaccination being \>10 percentage points (1-sided p-value \<0.025).|Percent Difference|26.0|||<|0.001|TWO_SIDED|95.0|20.9|31.0||1-sided|Stratified Miettinen & Nurminen method||V116 minus PPSV23|Serotype 6A: V116-PPSV23 Percentage Difference||31.0|20.9|<0.001
72407594|NCT05569954|144323597|SUPERIORITY|A conclusion of superiority is based on the lower bound of the 95% CI for the difference \[V116 - PPSV23\] between the percentages of participants with a ≥4-fold rise from baseline to 30 days postvaccination being \>10 percentage points (1-sided p-value \<0.025).|Percent Difference|39.4|||<|0.001|TWO_SIDED|95.0|33.6|44.8||1-sided|Stratified Miettinen & Nurminen method||V116 minus PPSV23|Serotype 15A: V116-PPSV23 Percentage Difference||44.8|33.6|<0.001
72529185|NCT01258738|144587892|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.19||||0.0193|TWO_SIDED|95.0|-16.85|-1.52|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2||-1.52|-16.85|0.0193
72529186|NCT01258738|144587892|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.08||||0.173|TWO_SIDED|95.0|-12.41|2.26|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4||2.26|-12.41|0.1730
72625560|NCT01968980|144780510|SUPERIORITY_OR_OTHER||LS Mean Difference|-35.8|STANDARD_ERROR_OF_MEAN|2.12|||TWO_SIDED|95.0|-40.0|-31.6||||||Week 24: LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region.||-31.6|-40.0|
72625561|NCT01968980|144780510|SUPERIORITY_OR_OTHER||LS Mean Difference|-31.8|STANDARD_ERROR_OF_MEAN|2.02|||TWO_SIDED|95.0|-35.8|-27.8||||||Week 52: LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region.||-27.8|-35.8|
72407595|NCT05569954|144323597|SUPERIORITY|A conclusion of superiority is based on the lower bound of the 95% CI for the difference \[V116 - PPSV23\] between the percentages of participants with a ≥4-fold rise from baseline to 30 days postvaccination being \>10 percentage points (1-sided p-value \<0.025).|Percent Difference|11.7||||0.214|TWO_SIDED|95.0|7.5|15.9||1-sided|Stratified Miettinen & Nurminen method||V116 minus PPSV23|Serotype 15C: V116-PPSV23 Percentage Difference||15.9|7.5|0.214
72407596|NCT05569954|144323597|SUPERIORITY|A conclusion of superiority is based on the lower bound of the 95% CI for the difference \[V116 - PPSV23\] between the percentages of participants with a ≥4-fold rise from baseline to 30 days postvaccination being \>10 percentage points (1-sided p-value \<0.025).|Percent Difference|42.9|||<|0.001|TWO_SIDED|95.0|37.8|47.8||1-sided|Stratified Miettinen & Nurminen method||V116 minus PPSV23|Serotype 16F: V116-PPSV23 Percentage Difference||47.8|37.8|<0.001
72407597|NCT05569954|144323597|SUPERIORITY|A conclusion of superiority is based on the lower bound of the 95% CI for the difference \[V116 - PPSV23\] between the percentages of participants with a ≥4-fold rise from baseline to 30 days postvaccination being \>10 percentage points (1-sided p-value \<0.025).|Percent Difference|35.9|||<|0.001||95.0|29.6|41.8||1-sided|Stratified Miettinen & Nurminen method||V16 minus PPSV23|Serotype 23A: V116-PPSV23 Percentage Difference||41.8|29.6|<0.001
72529187|NCT01258738|144587892|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.26||||0.1224|TWO_SIDED|95.0|-14.23|1.71|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8||1.71|-14.23|0.1224
72407598|NCT05569954|144323597|SUPERIORITY|A conclusion of superiority is based on the lower bound of the 95% CI for the difference \[V116 - PPSV23\] between the percentages of participants with a ≥4-fold rise from baseline to 30 days postvaccination being \>10 percentage points (1-sided p-value \<0.025).|Percent Difference|42.4|||<|0.001|TWO_SIDED|95.0|37.6|47.0||1-sided|Stratified Miettinen & Nurminen method||V116 minus PPSV23|Serotype 23B: V116-PPSV23 Percentage Difference||47.0|37.6|<0.001
72529188|NCT01258738|144587892|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.14||||0.0461|TWO_SIDED|95.0|-18.11|-0.16|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12||-0.16|-18.11|0.0461
72529189|NCT01258738|144587893|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||Within group comparisons to baseline were \<0.001, from paired t-test.||||<0.001
72529190|NCT01258738|144587893|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.97||||0.0372|TWO_SIDED|95.0|-11.58|-0.36|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2||-0.36|-11.58|0.0372
72529191|NCT01258738|144587893|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.1||||0.2126|TWO_SIDED|95.0|-7.98|1.79|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4||1.79|-7.98|0.2126
72529192|NCT01258738|144587893|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.66||||0.033|TWO_SIDED|95.0|-12.79|-0.54|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8||-0.54|-12.79|0.0330
72625562|NCT01968980|144780511|SUPERIORITY_OR_OTHER||LS Mean Difference|-48.5|STANDARD_ERROR_OF_MEAN|2.86|||TWO_SIDED|95.0|-54.1|-42.8||||||Week 24: LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region.||-42.8|-54.1|
72407599|NCT05569954|144323597|SUPERIORITY|A conclusion of superiority is based on the lower bound of the 95% CI for the difference \[V116 - PPSV23\] between the percentages of participants with a ≥4-fold rise from baseline to 30 days postvaccination being \>10 percentage points (1-sided p-value \<0.025).|Percent Difference|35.9|||<|0.001||95.0|30.6|41.0||1-sided|Stratified Miettinen & Nurminen method||V116 minus PPSV23|Serotype 24F: V116-PPSV23 Percentage Difference||41.0|30.6|<0.001
72407600|NCT05569954|144323597|SUPERIORITY|A conclusion of superiority is based on the lower bound of the 95% CI for the difference \[V116 - PPSV23\] between the percentages of participants with a ≥4-fold rise from baseline to 30 days postvaccination being \>10 percentage points (1-sided p-value \<0.025).|Percent Difference|56.2|||<|0.001|TWO_SIDED|95.0|51.5|60.5||1-sided|Stratified Miettinen & Nurminen method||V116 minus PPSV23|Serotype 31: V116-PPSV23 Percentage Difference||60.5|51.5|<0.001
72407601|NCT05569954|144323597|SUPERIORITY|A conclusion of superiority is based on the lower bound of the 95% CI for the difference \[V116 - PPSV23\] between the percentages of participants with a ≥4-fold rise from baseline to 30 days postvaccination being \>10 percentage points (1-sided p-value \<0.025).|Percent Difference|58.7|||<|0.001||95.0|54.6|62.7||1-sided|Stratified Miettinen & Nurminen method||V116 minus PPSV23|Serotype 35B: V116-PPSV23 Percentage Difference||62.7|54.6|<0.001
72407602|NCT05569954|144323598|OTHER|"A conclusion of acceptability is based on the lower bound of the 95% CI of the percentages of participants with a~≥4 fold rise from baseline to 30 days postvaccination being \>50 percentage points (1-sided p-value \<0.025)."||||||0.093||||||1-sided|Clopper-Pearson method|||Serotype 6C||||0.093
72407603|NCT05569954|144323598|OTHER|"A conclusion of acceptability is based on the lower bound of the 95% CI of the percentages of participants with a~≥4 fold rise from baseline to 30 days postvaccination being \>50 percentage points (1-sided p-value \<0.025)."|||||<|0.001||||||1-sided|Clopper-Pearson method|||Serotype 15B||||<0.001
72529193|NCT01258738|144587893|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.85||||0.0397|TWO_SIDED|95.0|-13.38|-0.33|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12||-0.33|-13.38|0.0397
72529194|NCT01258738|144587894|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||Within group comparisons to baseline were \<0.001 at Week 16 and at Week 32 and thereafter, from paired t test.||||<0.001
72571777|NCT02912650|144671806|SUPERIORITY_OR_OTHER||LS Mean Difference|1.75|||<|0.001|TWO_SIDED|95.0|0.85|2.66|||ANCOVA|||9 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||2.66|0.85|<0.001
72407604|NCT05569954|144323600|OTHER|GMCs, GMC ratio, and 95% CI are estimated from a cLDA model.|GMC Ratio|1.14|||||TWO_SIDED|95.0|1.04|1.25|||||V116/PPSV23|Serotype 3: V116/PPSV23 GMC Ratio||1.25|1.04|
72407605|NCT05569954|144323600|OTHER|GMCs, GMC ratio, and 95% CI are estimated from a cLDA model.|GMC Ratio|1.86|||||TWO_SIDED|95.0|1.65|2.1|||||V116/PPSV23|Serotype 7F: V116/PPSV23 GMC Ratio||2.10|1.65|
72407606|NCT05569954|144323600|OTHER|GMCs, GMC ratio, and 95% CI are estimated from a cLDA model.|GMC Ratio|1.17|||||TWO_SIDED|95.0|1.04|1.31|||||V116/PPSV23|Serotype 8: V116/PPSV23 GMC Ratio||1.31|1.04|
72407607|NCT05569954|144323600|OTHER|GMCs, GMC ratio, and 95% CI are estimated from a cLDA model.|GMC Ratio|1.55|||||TWO_SIDED|95.0|1.37|1.76|||||V116/PPSV23|Serotype 9N: V116/PPSV23 GMC Ratio||1.76|1.37|
72407608|NCT05569954|144323600|OTHER|GMCs, GMC ratio, and 95% CI are estimated from a cLDA model.|GMC Ratio|2.03|||||TWO_SIDED|95.0|1.79|2.31|||||V116/PPSV23|Serotype 10A: V116/PPSV23 GMC Ratio||2.31|1.79|
72407609|NCT05569954|144323600|OTHER|GMCs, GMC ratio, and 95% CI are estimated from a cLDA model.|GMC Ratio|2.2|||||TWO_SIDED|95.0|1.97|2.46|||||V116/PPSV23|Serotype 11A: V116/PPSV23 GMC Ratio||2.46|1.97|
72407610|NCT05569954|144323600|OTHER|GMCs, GMC ratio, and 95% CI are estimated from a cLDA model.|GMC Ratio|1.99|||||TWO_SIDED|95.0|1.72|2.3|||||V116/PPSV23|Serotype 12F: V116/PPSV23 GMC Ratio||2.30|1.72|
72407611|NCT05569954|144323600|OTHER|GMCs, GMC ratio, and 95% CI are estimated from a cLDA model.|GMC Ratio|2.39|||||TWO_SIDED|95.0|2.12|2.7|||||V116/PPSV23|Serotype 17F: V116/PPSV23 GMC Ratio||2.70|2.12|
72407612|NCT05569954|144323600|OTHER|GMCs, GMC ratio, and 95% CI are estimated from a cLDA model.|GMC Ratio|1.49|||||TWO_SIDED|95.0|1.32|1.67||||||Serotype 19A: V116/PPSV23 GMC Ratio|V116/PPSV23|1.67|1.32|
72407613|NCT05569954|144323600|OTHER|GMCs, GMC ratio, and 95% CI are estimated from a cLDA model.|GMC Ratio|1.86|||||TWO_SIDED|95.0|1.65|2.1|||||V116/PPSV23|Serotype 20A: V116/PPSV23 GMC Ratio||2.10|1.65|
72407614|NCT05569954|144323600|OTHER|GMCs, GMC ratio, and 95% CI are estimated from a cLDA model.|GMC Ratio|1.77|||||TWO_SIDED|95.0|1.55|2.02|||||V116/PPSV23|Serotype 22F: V116/PPSV23 GMC Ratio||2.02|1.55|
72407615|NCT05569954|144323600|OTHER|GMCs, GMC ratio, and 95% CI are estimated from a cLDA model.|GMC Ratio|1.22|||||TWO_SIDED|95.0|1.08|1.37|||||V116/PPSV23|Serotype 33F: V116/PPSV23 GMC Ratio||1.37|1.08|
72407616|NCT05569954|144323600|OTHER|GMCs, GMC ratio, and 95% CI are estimated from a cLDA model.|GMC Ratio|3.78|||||TWO_SIDED|95.0|3.29|4.35|||||V116/PPSV23|Serotype 6A: V116/PPSV23 GMC Ratio||4.35|3.29|
72407617|NCT05569954|144323600|OTHER|GMCs, GMC ratio, and 95% CI are estimated from a cLDA model.|GMC Ratio|8.92|||||TWO_SIDED|95.0|7.89|10.09|||||V116/PPSV23|Serotype 15A: V116/PPSV23 GMC Ratio||10.09|7.89|
72407618|NCT05569954|144323600|OTHER|GMCs, GMC ratio, and 95% CI are estimated from a cLDA model.|GMC Ratio|3.43|||||TWO_SIDED|95.0|3.01|3.92|||||V116/PPSV23|Serotype 15C: V116/PPSV23 GMC Ratio||3.92|3.01|
72529195|NCT01258738|144587894|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.29||||0.0382|TWO_SIDED|95.0|-16.12|-0.46|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2||-0.46|-16.12|0.0382
72571778|NCT02912650|144671806|SUPERIORITY_OR_OTHER||LS Mean Difference|0.14||||0.669|TWO_SIDED|95.0|-0.49|0.77|||ANCOVA|||9 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||0.77|-0.49|0.669
72571779|NCT02912650|144671806|SUPERIORITY_OR_OTHER||LS Mean Difference|0.89||||0.007|TWO_SIDED|95.0|0.24|1.53|||ANCOVA|||9 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||1.53|0.24|0.007
72407619|NCT05569954|144323600|OTHER|GMCs, GMC ratio, and 95% CI are estimated from a cLDA model.|GMC Ratio|9.84|||||TWO_SIDED|95.0|8.83|10.97|||||V116/PPSV23|Serotype 16F: V116/PPSV23 GMC Ratio||10.97|8.83|
72407620|NCT05569954|144323600|OTHER|GMCs, GMC ratio, and 95% CI are estimated from a cLDA model.|GMC Ratio|7.59|||||TWO_SIDED|95.0|6.68|8.61|||||V116/PPSV23|Serotype 23A: V116/PPSV23 GMC Ratio||8.61|6.68|
72407621|NCT05569954|144323600|OTHER|GMCs, GMC ratio, and 95% CI are estimated from a cLDA model.|GMC Ratio|4.79|||||TWO_SIDED|95.0|4.26|5.38|||||V116/PPSV23|Serotype 23B: V116/PPSV23 GMC Ratio||5.38|4.26|
72407622|NCT05569954|144323600|OTHER|GMCs, GMC ratio, and 95% CI are estimated from a cLDA model.|GMC Ratio|21.19||||||95.0|18.98|23.65|||||V116/PPSV23|Serotype 24F: V116/PPSV23 GMC Ratio||23.65|18.98|
72407623|NCT05569954|144323600|OTHER|GMCs, GMC ratio, and 95% CI are estimated from a cLDA model.|GMC Ratio|8.69|||||TWO_SIDED|95.0|7.82|9.65|||||V116/PPSV23|Serotype 31: V116/PPSV23 GMC Ratio||9.65|7.82|
72407624|NCT05569954|144323600|OTHER|GMCs, GMC ratio, and 95% CI are estimated from a cLDA model.|GMC Ratio|15.53|||||TWO_SIDED|95.0|14.13|17.07|||||V116/PPSV23|Serotype 35B: V116/PPSV23 GMC Ratio||17.07|14.13|
72407625|NCT01660412|144323604|OTHER||Mean Difference (Final Values)|1.42|STANDARD_DEVIATION|2.17|<|0.0001|TWO_SIDED|95.0|0.85|2.0|||t-test, 2 sided|||||2.00|0.85|<0.0001
72407626|NCT02239536|144323605|OTHER|||||||0.05|||||||Chi-squared|||||||0.05
72407627|NCT02239536|144323606|OTHER|||||||0.05|||||||Chi-squared|||||||0.05
72407628|NCT02239536|144323606|OTHER|||||||0.001|||||||Chi-squared|||||||0.001
72529196|NCT01258738|144587894|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.25||||0.1648|TWO_SIDED|95.0|-12.69|2.19|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4||2.19|-12.69|0.1648
72529197|NCT01258738|144587894|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.98||||0.1476|TWO_SIDED|95.0|-14.11|2.15|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8||2.15|-14.11|0.1476
72529198|NCT01258738|144587894|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.68||||0.0687|TWO_SIDED|95.0|-18.03|0.68|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12||0.68|-18.03|0.0687
72529199|NCT01258738|144587895|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||All within group comparisons to baseline were \<0.001, from paired t-test.||||<0.001
72529200|NCT01258738|144587895|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.44||||0.2578|TWO_SIDED|95.0|-1.21|0.33|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 4, 12 data only. Week 4||0.33|-1.21|0.2578
72529201|NCT01258738|144587895|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.35||||0.4334|TWO_SIDED|95.0|-1.21|0.52|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 4, 12 data only. Week 12||0.52|-1.21|0.4334
72529202|NCT01258738|144587896|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||All within group comparisons to baseline were \<0.001, from paired t-test.||||<0.001
72529203|NCT01258738|144587896|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.5||||0.3554|TWO_SIDED|95.0|-4.7|1.7|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 4, 12 data only. Week 4||1.70|-4.70|0.3554
72529204|NCT01258738|144587896|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.91||||0.335|TWO_SIDED|95.0|-5.82|1.99|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 4, 12 data only. Week 12||1.99|-5.82|0.3350
72529205|NCT01258738|144587897|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.41||||14.41|TWO_SIDED|95.0|0.04|28.78|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Descriptive analysis was carried out for Week 12 data only.||28.78|0.04|14.41
72529206|NCT01258738|144587898|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.03||||0.1285|TWO_SIDED|95.0|-2.51|24.56|||Cochran-Mantel-Haenszel|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Descriptive analysis was carried out for Week 12 data only.||24.56|-2.51|0.1285
72529207|NCT00568399|144587901|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.2|STANDARD_DEVIATION|0.987||0.001|TWO_SIDED|95.0||||Coronary calcium score after treatment compared to baseline|Wilcoxon (Mann-Whitney)|||This was a pilot study without a control group. There were no power calculations (see manuscript).||||0.001
72529208|NCT00783263|144587926|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-15.25|||<|0.001|TWO_SIDED|95.0|-19.89|-10.6|||Longitudinal Data Analysis (LDA)|Longitudinal Data Analysis was based on a constrained LDA model with terms for treatment, time, stratum and the interaction of time by treatment.||||-10.60|-19.89|<0.001
72529209|NCT00783263|144587927|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-12.31|||<|0.001|TWO_SIDED|95.0|-18.95|-5.67|||Longitudinal Data Analysis (LDA)|Longitudinal Data Analysis was based on a constrained LDA model with terms for treatment, time and the interaction of time by treatment.||||-5.67|-18.95|<0.001
72529210|NCT00783263|144587927|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-17.46|||<|0.001|TWO_SIDED|95.0|-23.92|-10.99|||Longitudinal Data Analysis (LDA)|Longitudinal Data Analysis was based on a constrained LDA model with terms for treatment, time and the interaction of time by treatment.||||-10.99|-23.92|<0.001
72529211|NCT00783263|144587928|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|4.5|||<|0.001|TWO_SIDED|95.0|2.9|6.9|||Logistic Regression|Logistic Regression included terms for treatment, stratum and baseline LDL-C category (3 levels: \<100, 100-\<130, ≥130 mg/dL).||||6.9|2.9|<0.001
72529212|NCT00783263|144587929|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|3.1|||<|0.001|TWO_SIDED|95.0|1.7|5.8|||Logistic Regression|Logistic Regression included terms for treatment and baseline LDL-C category (3 levels: \<100, 100-\<130, \>=130 mg/dL).||||5.8|1.7|<0.001
72529213|NCT00783263|144587929|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|6.5|||<|0.001|TWO_SIDED|95.0|3.4|12.3|||Logistic Regression|Logistic Regression included terms for treatment and baseline LDL-C category (3 levels: \<100, 100-\<130, \>=130 mg/dL).||||12.3|3.4|<0.001
72529214|NCT00783263|144587930|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|8.0|||<|0.001|TWO_SIDED|95.0|4.6|14.0|||Logistic Regression|||||14.0|4.6|<0.001
72529215|NCT00783263|144587931|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|5.1|||<|0.001|TWO_SIDED|95.0|2.2|11.8|||Logistic Regression|||Stratum I||11.8|2.2|<0.001
72529216|NCT00783263|144587931|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|11.4|||<|0.001|TWO_SIDED|95.0|5.2|24.8|||Logistic Regression|||Stratum II||24.8|5.2|<0.001
72529217|NCT00783263|144587932|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-8.65|||<|0.001|TWO_SIDED|95.0|-11.59|-5.71|||Longitudinal Data Analysis|||Total Cholesterol (mg/dL)||-5.71|-11.59|<0.001
72529218|NCT00783263|144587932|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.1||||0.306|TWO_SIDED|95.0|-9.04|2.84|||Longitudinal Data Analysis|||Triglycerides (mg/dL)||2.84|-9.04|0.306
72529219|NCT00783263|144587932|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.15||||0.111|TWO_SIDED|95.0|-4.79|0.49|||Longitudinal Data Analysis|||High-Density Lipoprotein Cholesterol||0.49|-4.79|0.111
72529220|NCT00783263|144587932|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-11.98|||<|0.001|TWO_SIDED|95.0|-16.1|-7.86|||Longitudinal Data Analysis|||Non High-Density Liproprotein Cholesterol||-7.86|-16.10|<0.001
72529221|NCT00783263|144587932|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-13.25|||<|0.001|TWO_SIDED|95.0|-18.36|-8.13|||Longitudinal Data Analysis|||LDL Cholesterol/HDL Cholesterol||-8.13|-18.36|<0.001
72571780|NCT02912650|144671806|SUPERIORITY_OR_OTHER||LS Mean Difference|1.61|||<|0.001|TWO_SIDED|95.0|0.71|2.52|||ANCOVA|||9 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||2.52|0.71|<0.001
72529222|NCT00783263|144587932|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.45||||0.002|TWO_SIDED|95.0|-10.53|-2.36|||Longitudinal Data Analysis|||Total Cholesterol/HDL Cholesterol||-2.36|-10.53|0.002
72529223|NCT00783263|144587932|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-9.52||||0.001|TWO_SIDED|95.0|-15.3|-3.75|||Longitudinal Data Analysis|||Non-HDL Cholestrol/HDL Cholesterol||-3.75|-15.30|0.001
72529224|NCT00783263|144587932|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-9.41|||<|0.001|TWO_SIDED|95.0|-12.74|-6.08|||Longitudinal Data Analysis|||Apolipoprotein B (Apo B)||-6.08|-12.74|<0.001
72529225|NCT00783263|144587932|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.82||||0.102|TWO_SIDED|95.0|-3.99|0.36|||Longitudinal Data Analysis|||Apolipoprotein A-I (Apo A-I)||0.36|-3.99|0.102
72529226|NCT00783263|144587932|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-7.54|||<|0.001|TWO_SIDED|95.0|-11.25|-3.83|||Longitudinal Data Analysis|||Apolipoprotein B/Apo A-I||-3.83|-11.25|<0.001
72529227|NCT00783263|144587932|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.08||||0.861|TWO_SIDED|95.0|-13.13|10.97|||Longitudinal Data Analysis|||hs-C-Reactive Protein||10.97|-13.13|0.861
72529228|NCT00405756|144587933|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.395|||<|0.001|TWO_SIDED|95.0|0.278|0.56||The p-value is based on unstratified log rank test of Kaplan-Meier curve differences between the treatment groups.|Log Rank|||||0.560|0.278|<0.001
72529229|NCT00405756|144587933|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.494|||<|0.001|TWO_SIDED|95.0|0.347|0.702||The p-value is based on unstratified log rank test of Kaplan-Meier curve differences between the treatment groups.|Log Rank|||||0.702|0.347|<0.001
72529230|NCT00405756|144587933|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.796||||0.134|TWO_SIDED|95.0|0.589|1.075||The p-value is based on unstratified log rank test of Kaplan-Meier curve differences between the treatment groups.|Log Rank|||||1.075|0.589|0.134
72529231|NCT00405756|144587934|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.34|||<|0.001|TWO_SIDED|95.0|0.214|0.541|||Log Rank|P-value is based on unstratified log rank test of Kaplan-Meier curve differences between the treatment groups.||||0.541|0.214|<0.001
72529232|NCT00405756|144587936|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.337|||<|0.001|TWO_SIDED|95.0|0.231|0.493||The p-value is based on unstratified log rank test of Kaplan-Meier curve differences between the treatment groups.|Log Rank|||||0.493|0.231|<0.001
72529233|NCT00405756|144587936|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.414|||<|0.001|TWO_SIDED|95.0|0.284|0.603||The p-value is based on unstratified log rank test of Kaplan-Meier curve differences between the treatment groups.|Log Rank|||||0.603|0.284|<0.001
72571781|NCT02912650|144671806|SUPERIORITY_OR_OTHER||LS Mean Difference|0.86||||0.063|TWO_SIDED|95.0|-0.05|1.78|||ANCOVA|||9 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||1.78|-0.05|0.063
72529234|NCT00405756|144587936|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.826||||0.223|TWO_SIDED|95.0|0.606|1.125||The p-value is based on unstratified log rank test of Kaplan-Meier curve differences between the treatment groups.|Log Rank|||||1.125|0.606|0.223
72529235|NCT00405756|144587937|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value calculation excludes the category - Response not evaluable (NE)|Wilcoxon (Mann-Whitney)|||||||<0.001
72529236|NCT00405756|144587937|SUPERIORITY_OR_OTHER|||||||0.009||95.0||||P-value calculation excludes the category - Response not evaluable (NE)|Wilcoxon (Mann-Whitney)|||||||0.009
72529237|NCT00405756|144587937|SUPERIORITY_OR_OTHER|||||||0.003||95.0||||P-value calculation excludes the category - Response not evaluable (NE)|Wilcoxon (Mann-Whitney)|||||||0.003
72529238|NCT00405756|144587937|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.34|||<|0.001|TWO_SIDED|95.0|2.04|5.47|||Fisher Exact|||Based on dichotomized response: 1) CR or PR 2) SD or PD or NE||5.47|2.04|<0.001
72529239|NCT00405756|144587937|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.58||||0.096|TWO_SIDED|95.0|0.95|2.62|||Fisher Exact|||Based on dichotomized response: 1) CR or PR 2) SD or PD or NE||2.62|0.95|0.096
72571782|NCT02912650|144671806|SUPERIORITY_OR_OTHER||LS Mean Difference|0.75||||0.022|TWO_SIDED|95.0|0.11|1.39|||ANCOVA|||9 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||1.39|0.11|0.022
72407629|NCT01034397|144323673|SUPERIORITY_OR_OTHER|||||||1||||||Wrist region: Tocilizumab versus placebo; Since one-sided t-test was used all effects in the opposite direction of what was predicted have a p-value=1.|t-test, 1 sided|||||||1.00
72407630|NCT01034397|144323673|SUPERIORITY_OR_OTHER|||||||0.026||||||2nd and 5th MCP joints: Tocilizumab versus placebo|t-test, 1 sided|||||||0.026
72407631|NCT01034397|144323673|SUPERIORITY_OR_OTHER|||||||1||||||Total synovitis score: Tocilizumab versus placebo; Since one-sided t-test was used all effects in the opposite direction of what was predicted have a p-value=1.|t-test, 1 sided|||||||1.00
72407632|NCT01034397|144323674|SUPERIORITY_OR_OTHER|||||||0.421||||||Percentage Change in OMERACT RAMRIS global score; Tocilizumab versus placebo.|t-test, 1 sided|||||||0.421
72407633|NCT01034397|144323675|SUPERIORITY_OR_OTHER|||||||0.434||||||Absolute change in OMERACT RAMRIS global score; Placebo versus Tocilizumab|t-test, 1 sided|||||||0.434
72407634|NCT01034397|144323678|SUPERIORITY_OR_OTHER|||||||1||||||Change in Wrist region; Tocilizumab versus placebo. Since one-sided t-test was used all effects in the opposite direction of what was predicted have a p-value=1.|t-test, 1 sided|||||||1.00
72529240|NCT00405756|144587937|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.12||||0.002|TWO_SIDED|95.0|1.33|3.37|||Fisher Exact|||Based on dichotomized response: 1) CR or PR 2) SD or PD or NE||3.37|1.33|0.002
72529241|NCT00405756|144587939|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.348|||<|0.001|TWO_SIDED|95.0|0.228|0.531||The p-value is based on unstratified log rank test of Kaplan Meier curve differences between the treatment groups.|Log Rank|||||0.531|0.228|<0.001
72625563|NCT01968980|144780511|SUPERIORITY_OR_OTHER||LS Mean Difference|-42.2|STANDARD_ERROR_OF_MEAN|2.71|||TWO_SIDED|95.0|-47.5|-36.9||||||Week 52: LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region.||-36.9|-47.5|
72407635|NCT01034397|144323678|SUPERIORITY_OR_OTHER|||||||0.065||||||Change in 2nd to 5th MCP; Tocilizumab versus placebo.|t-test, 1 sided|||||||0.065
72407636|NCT01034397|144323678|SUPERIORITY_OR_OTHER|||||||1||||||Change in Total synovitis; Tocilizumab versus placebo. Since one-sided t-test was used all effects in the opposite direction of what was predicted have a p-value=1.|t-test, 1 sided|||||||1.00
72407637|NCT01034397|144323680|SUPERIORITY_OR_OTHER|||||||1||||||Absolute Change in Bone erosion; Tocilizumab versus placebo. Since one-sided t-test was used all effects in the opposite direction of what was predicted have a p-value=1.|t-test, 1 sided|||||||1.00
72407638|NCT01034397|144323681|SUPERIORITY_OR_OTHER|||||||1||||||Percentage Change in Bone erosion; Tocilizumab versus placebo. Since one-sided t-test was used all effects in the opposite direction of what was predicted have a p-value=1.|t-test, 1 sided|||||||1.00
72407639|NCT01034397|144323684|SUPERIORITY_OR_OTHER|||||||0.266||||||Percentage Change in Bone oedema; Tocilizumab versus placebo.|t-test, 1 sided|||||||0.266
72407640|NCT01034397|144323685|SUPERIORITY_OR_OTHER|||||||0.337||||||Absolute Change in Bone edema; Tocilizumab versus placebo.|t-test, 1 sided|||||||0.337
72407641|NCT01034397|144323688|SUPERIORITY_OR_OTHER|||||||0.114||||||Percentage change in DCE-MRI EER (global); Placebo versus Tocilizumab|t-test, 1 sided|||||||0.114
72407642|NCT01034397|144323689|SUPERIORITY_OR_OTHER|||||||0.239||||||Absolute Change in DCE-MRI EER; Tocilizumab versus placebo.|t-test, 1 sided|||||||0.239
72407643|NCT01034397|144323692|SUPERIORITY_OR_OTHER|||||||0.271||||||Percentage change in DCE-MRI EER (MCP); Placebo versus Tocilizumab|t-test, 1 sided|||||||0.271
72407644|NCT01034397|144323693|SUPERIORITY_OR_OTHER|||||||0.37||||||Absolute change in DCE-MRI EER (MCP); Placebo versus Tocilizumab|t-test, 1 sided|||||||0.370
72407645|NCT01034397|144323696|SUPERIORITY_OR_OTHER|||||||1||||||Percentage and absolute change in DCE-MRI EER (wrist); Placebo versus Tocilizumab|t-test, 1 sided|||||||1.00
72407646|NCT01034397|144323701|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 1 sided|||||||<0.001
72407647|NCT01034397|144323704|SUPERIORITY_OR_OTHER|||||||0.067|||||||t-test, 1 sided|||||||0.067
72407648|NCT01034397|144323706|SUPERIORITY_OR_OTHER|||||||0.001|||||||t-test, 1 sided|||||||0.001
72529242|NCT00405756|144587939|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.419|||<|0.001|TWO_SIDED|95.0|0.281|0.623||The p-value is based on unstratified log rank test of Kaplan Meier curve differences between the treatment groups.|Log Rank|||||0.623|0.281|<0.001
72529243|NCT00405756|144587939|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.825||||0.302|TWO_SIDED|95.0|0.571|1.191||The p-value is based on unstratified log rank test of Kaplan Meier curve differences between the treatment groups.|Log Rank|||||1.191|0.571|0.302
72407649|NCT01034397|144323708|SUPERIORITY_OR_OTHER|||||||0.002|||||||t-test, 1 sided|||||||0.002
72407650|NCT01034397|144323710|SUPERIORITY_OR_OTHER||||||<|0.001||||||Change from Baseline to Week 12|Friedman's T test|||||||<0.001
72407651|NCT01034397|144323710|SUPERIORITY_OR_OTHER|||||||0.5||||||Change from Baseline to Week 12|Friedman's T test|||||||0.500
72407652|NCT01034397|144323711|SUPERIORITY_OR_OTHER|||||||0.007|||||||t-test, 1 sided|||||||0.007
72407653|NCT01034397|144323714|SUPERIORITY_OR_OTHER|||||||0.001|||||||t-test, 1 sided|||||||0.001
72407654|NCT01034397|144323716|SUPERIORITY_OR_OTHER|||||||0.002|||||||t-test, 1 sided|||||||0.002
72407655|NCT01034397|144323718|SUPERIORITY_OR_OTHER|||||||0.118|||||||t-test, 1 sided|||||||0.118
72407656|NCT01034397|144323720|SUPERIORITY_OR_OTHER|||||||1|||||||t-test, 1 sided|||||||1.00
72407657|NCT01034397|144323722|SUPERIORITY_OR_OTHER|||||||0.437|||||||t-test, 1 sided|||||||0.437
72407658|NCT01034397|144323723|SUPERIORITY_OR_OTHER|||||||1|||||||t-test, 1 sided|||||||1.00
72407659|NCT01034397|144323726|SUPERIORITY_OR_OTHER|||||||0.19|||||||t-test, 1 sided|||||||0.190
72407660|NCT01034397|144323728|SUPERIORITY_OR_OTHER|||||||0.051|||||||t-test, 1 sided|||||||0.051
72407661|NCT01018264|144323730|SUPERIORITY_OR_OTHER_LEGACY||Effect size|0.2||||0.53|TWO_SIDED||||||ANCOVA|Adjusted for baseline value|This represents the effect size between solifenacin and placebo.|||||0.53
72407662|NCT01018264|144323731|SUPERIORITY_OR_OTHER_LEGACY||Effect size|0.53||||0.01|TWO_SIDED||||||ANCOVA|||||||0.01
72529244|NCT00405756|144587940|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.404|||<|0.001|TWO_SIDED|95.0|0.296|0.553||The p-value is based on unstratified log rank test of Kaplan Meier curve differences between the treatment groups.|Log Rank|||||0.553|0.296|<0.001
72407663|NCT01018264|144323732|SUPERIORITY_OR_OTHER_LEGACY||Effect size|0.35||||0.22|TWO_SIDED||||||ANCOVA|||||||0.22
72407664|NCT01018264|144323733|SUPERIORITY_OR_OTHER_LEGACY||Effect size|0.27||||0.47|TWO_SIDED||||||ANCOVA|||||||0.47
72407665|NCT01018264|144323734|SUPERIORITY_OR_OTHER_LEGACY||Effect size|0.11||||0.94|TWO_SIDED||||||ANCOVA|||||||0.94
72529245|NCT00405756|144587940|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.499|||<|0.001|TWO_SIDED|95.0|0.363|0.688||The p-value is based on unstratified log rank test of Kaplan Meier curve differences between the treatment groups.|Log Rank|||||0.688|0.363|<0.001
72529246|NCT00405756|144587940|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.827||||0.169|TWO_SIDED|95.0|0.63|1.085||The p-value is based on unstratified log rank test of Kaplan Meier curve differences between the treatment groups.|Log Rank|||||1.085|0.630|0.169
72529247|NCT01038635|144587961|SUPERIORITY_OR_OTHER||Maximal tolerated dose|75.0|||||TWO_SIDED||||||||Maximal tolerated dose not reached as no dose limiting toxicity documented. MTD considered to be last dose level.|||||
72529248|NCT03018340|144587976|SUPERIORITY||Difference in weighted MMRM LSMs|-1.7|STANDARD_ERROR_OF_MEAN|0.85||0.039|TWO_SIDED|95.0|-3.4|-0.1|||Mixed Models Analysis|||This is the primary statistical comparison for Stage 1 and Stage 2 combined.||-0.1|-3.4|0.0390
72529249|NCT03018340|144587976|SUPERIORITY||Difference in MMRM LSMs|-4.0|STANDARD_ERROR_OF_MEAN|1.09||0.0003|TWO_SIDED|95.0|-6.1|-1.9|||Mixed Models Analysis|||||-1.9|-6.1|0.0003
72529250|NCT03018340|144587976|SUPERIORITY||Difference in MMRM LSMs|0.5|STANDARD_ERROR_OF_MEAN|1.3||0.694|TWO_SIDED|95.0|-2.1|3.1|||Mixed Models Analysis|||||3.1|-2.1|0.6940
72529251|NCT00203294|144588040|SUPERIORITY_OR_OTHER||||||<|0.01||95.0||||Separate models were fit to the change scores for headache pain, nausea and vomiting, photophobia, phonophobia, and neck pain.|Fisher Exact|||Fisher's exact test was used to compare nominal variables between groups. The Wilcoxon rank-sum test was used to compare interval and ordinal variables between groups.||||<0.01
72529252|NCT00203294|144588040|SUPERIORITY_OR_OTHER||||||<|0.01||95.0|||||Fisher Exact|Wilcoxon rank-sum test was used to compare interval and ordinal variables between groups.||Fisher's exact test was used to compare nominal variables between groups.||||<0.01
72529253|NCT00082628|144588044|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Nonparametric ANCOVA Model|||||||<0.001
72529254|NCT01566981|144588049|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.6925|STANDARD_DEVIATION|1.4708||0.005|TWO_SIDED|95.0|0.2221|1.1629|||t-test, 2 sided|without adjustments, df=39||"Null hypothesis was that Information and Communication Technology (ICT) supported diabetes care could have significant impact on reduction of baseline glycated hemoglobin (EHbA1c) after 1 year follow-up.~The sample in intervention group was normally distributed, so observed power (two-tailed hypothesis) was 0.45, for Cohen's d= 0.6 and alpha level =0.05"||1.1629|0.2221|0.005
72529255|NCT03481634|144588059|NON_INFERIORITY|Non-inferiority (4-letter margin)|LS mean difference|-1.3|STANDARD_ERROR_OF_MEAN|0.81|<|0.001|TWO_SIDED|95.0|-2.9|0.3||1-sided p-value|ANOVA|||||0.3|-2.9|<0.001
72529256|NCT03481634|144588059|NON_INFERIORITY|Non-inferiority (4-letter margin)|LS mean difference|-3.3|STANDARD_ERROR_OF_MEAN|0.94||0.227|TWO_SIDED|95.0|-5.1|-1.4||1-sided p-value|ANOVA|||||-1.4|-5.1|0.227
72529257|NCT03481634|144588060|NON_INFERIORITY|Non-inferiority (4-letter margin)|Mean Difference (Net)|-1.5|STANDARD_ERROR_OF_MEAN|0.75|<|0.001|TWO_SIDED|95.0|-3.0|0.0||(1-sided)|ANOVA|||||-0.0|-3.0|<0.001
72407666|NCT03915548|144323755|OTHER|Group by time interaction (difference in trajectory)||||||0.54||||||Adjusted|Mixed Models Analysis|multiple-degree-of-freedom test|||F(3,747)=0.88|||.54
72407667|NCT03915548|144323756|OTHER|Group by time interaction (difference in trajectory)||||||0.09||||||Adjusted|Mixed Models Analysis|multiple-degree-of-freedom test|||F(3,746.4)=2.64|||.09
72407668|NCT03915548|144323757|OTHER|Group by time interaction (difference in trajectory)||||||0.55||||||Adjusted|Mixed Models Analysis|Poisson model with log link; multiple-degree-of-freedom test|||F(3,717)=0.7|||.55
72407669|NCT03915548|144323758|OTHER|Group by time interaction (difference in trajectory)||||||0.99||||||Adjusted|Mixed Models Analysis|multiple-degree-of-freedom test|||F(3,394.7)=0.18|||.99
72407670|NCT03915548|144323759|OTHER|Group by time interaction (difference in trajectory)||||||0.99||||||Overall score adjusted P = 0.99 Physical subscale adjusted P = 0.99 Social subscale adjusted P = 0.99 Emotional subscale adjusted P = 0.99 Functional subscale adjusted P = 0.99|Mixed Models Analysis|multiple-degree-of-freedom test|||"Group by time interaction:~Overall score: F(3,731.3)=0.03 Physical subscale: F(3,744.5)=0.23 Social subscale: F(3,740.6)=0.32 Emotional subscale: F(3,743)=0.46 Functional subscale: F(3,746.1)=0.3"|||0.99
72407671|NCT03915548|144323760|OTHER|Group by time interaction (difference in trajectory)||||||0.99||||||Active coping adjusted P = 0.99 Planning adjusted P = 0.21 Positive reframing adjusted P = 0.99|Mixed Models Analysis|multiple-degrees-of-freedom test|||Active planning: F(3,746)=0.8 Planning: F(3,744.8)=2.93 Positive reframing = F(3,742)=0.21|||0.99
72407672|NCT03915548|144323761|OTHER|Group by time interaction (difference in trajectory)||||||0.02|||||||Mixed Models Analysis|multiple-degrees-of-freedom test|||Disengagement: F(3,741.2)=5.09 Reengagement: F(3,745.7)=0.81|||0.02
72529258|NCT03481634|144588060|NON_INFERIORITY|Non-inferiority (4-letter margin)|Mean Difference (Net)|-3.5|STANDARD_ERROR_OF_MEAN|0.9|||TWO_SIDED|95.0|-5.2|-1.7||(1-sided)|ANOVA|||||-1.7|-5.2|
72529259|NCT03481634|144588064|OTHER|Descriptive|LS mean difference|-3.8|STANDARD_ERROR_OF_MEAN|1.09|||TWO_SIDED|95.0|-6.0|-1.7|||ANOVA|||||-1.7|-6.0|
72529260|NCT03481634|144588064|OTHER|Descriptive|LS mean difference|-2.0|STANDARD_ERROR_OF_MEAN|1.03|||TWO_SIDED|95.0|-4.0|0.1|||ANOVA|||||0.1|-4.0|
72529261|NCT03481634|144588067|OTHER|Descriptive|LS mean difference|-0.7|STANDARD_ERROR_OF_MEAN|8.68|||TWO_SIDED|95.0|-17.7|16.4|||ANOVA|||Week 4||16.4|-17.7|
72529262|NCT03481634|144588067|OTHER|Descriptive|LS mean difference|-2.1|STANDARD_ERROR_OF_MEAN|8.41|||TWO_SIDED|95.0|-18.7|14.4|||ANOVA|||Week 4||14.4|-18.7|
72529263|NCT03481634|144588067|OTHER|Descriptive|LS mean difference|12.2|STANDARD_ERROR_OF_MEAN|8.87|||TWO_SIDED|95.0|-5.2|29.7|||ANOVA|||Week 6||29.7|-5.2|
72529264|NCT03481634|144588067|OTHER|Descriptive|LS mean difference|2.4|STANDARD_ERROR_OF_MEAN|8.38|||TWO_SIDED|95.0|-14.0|18.9|||ANOVA|||Week 6||18.9|-14.0|
72529265|NCT03481634|144588067|OTHER|Descriptive|LS mean difference|1.0|STANDARD_ERROR_OF_MEAN|8.61|||TWO_SIDED|95.0|-16.0|17.9|||ANOVA|||Week 8||17.9|-16.0|
72529266|NCT03481634|144588067|OTHER|Descriptive|LS mean difference|-3.4|STANDARD_ERROR_OF_MEAN|8.28|||TWO_SIDED|95.0|-19.6|12.9|||ANOVA|||Week 8||12.9|-19.6|
72407673|NCT03915548|144323762|OTHER|Group by time interaction (difference in trajectory)||||||0.99||||||Anxiety adjusted P = 0.99 Depression adjusted P = 0.99|Mixed Models Analysis|multiple-degrees-of-freedom test|||Anxiety: F(3,737.5)=0.17 Depression: F(3,733.6)=0.85|||0.99
72529267|NCT03481634|144588067|OTHER|Descriptive|LS mean difference|6.4|STANDARD_ERROR_OF_MEAN|8.73|||TWO_SIDED|95.0|-10.7|23.6|||ANOVA|||Week 12||23.6|-10.7|
72529268|NCT03481634|144588067|OTHER|Descriptive|LS mean difference|2.8|STANDARD_ERROR_OF_MEAN|8.85|||TWO_SIDED|95.0|-14.6|20.2|||ANOVA|||Week 12||20.2|-14.6|
72529269|NCT03481634|144588067|OTHER|Descriptive|LS mean difference|1.0|STANDARD_ERROR_OF_MEAN|8.5|||TWO_SIDED|95.0|-15.7|17.8|||ANOVA|||Week 16||17.8|-15.7|
72529270|NCT03481634|144588067|OTHER|Descriptive|LS mean difference|-3.4|STANDARD_ERROR_OF_MEAN|8.29|||TWO_SIDED|95.0|-19.7|12.9|||ANOVA|||Week 16||12.9|-19.7|
72529271|NCT03481634|144588067|OTHER|Descriptive|LS mean difference|8.9|STANDARD_ERROR_OF_MEAN|8.92|||TWO_SIDED|95.0|-8.6|26.5|||ANOVA|||Week 18||26.5|-8.6|
72529272|NCT03481634|144588067|OTHER|Descriptive|LS mean difference|2.6|STANDARD_ERROR_OF_MEAN|8.47|||TWO_SIDED|95.0|-14.1|19.2|||ANOVA|||Week 18||19.2|-14.1|
72529273|NCT03481634|144588067|OTHER|Descriptive|LS mean difference|-3.4|STANDARD_ERROR_OF_MEAN|8.55|||TWO_SIDED|95.0|-20.2|13.4|||ANOVA|||Week 20||13.4|-20.2|
72529274|NCT03481634|144588067|OTHER|Descriptive|LS mean difference|-5.8|STANDARD_ERROR_OF_MEAN|8.12|||TWO_SIDED|95.0|-21.7|10.2|||ANOVA|||Week 20||10.2|-21.7|
72529275|NCT03481634|144588067|OTHER|Descriptive|LS mean difference|-13.9|STANDARD_ERROR_OF_MEAN|9.06|||TWO_SIDED|95.0|-31.7|3.9|||ANOVA|||Week 24||3.9|-31.7|
72571783|NCT02912650|144671806|SUPERIORITY_OR_OTHER||LS Mean Difference|1.22||||0.008|TWO_SIDED|95.0|0.32|2.12|||ANCOVA|||10 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||2.12|0.32|0.008
72529276|NCT03481634|144588067|OTHER|Descriptive|LS mean difference|-17.8|STANDARD_ERROR_OF_MEAN|8.95|||TWO_SIDED|95.0|-35.4|-0.2|||ANOVA|||Week 24||-0.2|-35.4|
72529277|NCT03481634|144588067|OTHER|Descriptive|LS mean difference|-8.7|STANDARD_ERROR_OF_MEAN|8.26|||TWO_SIDED|95.0|-25.0|7.5|||ANOVA|||Week 28||7.5|-25.0|
72407674|NCT03915548|144323763|SUPERIORITY||Cohen's d|0.26||||0.09|TWO_SIDED|95.0|-0.01|0.54||Importance subscale: Adjusted P = .09 Performance subscale: Adjusted P = \<.001 Satisfaction subscale: Adjusted P = \<.001|Mixed Models Analysis|multiple-degrees-of-freedom test|Importance subscale: Cohen's d = 0.26 (-.01, 0.54) Performance subscale: Cohen's d = 0.60 (0.32, 0.87) Satisfaction subscale: Cohen's d = 0.76 (0.48, 1.02)|||0.54|-.01|.09
72407675|NCT03217136|144323764|OTHER|The Miettinen \& Nurminen method was used.|Difference in Percentage|18.1|||||TWO_SIDED|95.0|-2.6|41.1||||||Difference in Percentage (C/T+MTZ minus MERO)||41.1|-2.6|
72529278|NCT03481634|144588067|OTHER|Descriptive|LS mean difference|-8.7|STANDARD_ERROR_OF_MEAN|8.49|||TWO_SIDED|95.0|-25.4|8.0|||ANOVA|||Week 28||8.0|-25.4|
72529279|NCT03481634|144588067|OTHER|Descriptive|LS mean difference|-3.2|STANDARD_ERROR_OF_MEAN|9.49|||TWO_SIDED|95.0|-21.8|15.5|||ANOVA|||Week 32||15.5|-21.8|
72529280|NCT03481634|144588067|OTHER|Descriptive|LS mean difference|-11.7|STANDARD_ERROR_OF_MEAN|9.02|||TWO_SIDED|95.0|-29.5|6.0|||ANOVA|||Week 32||6.0|-29.5|
72529281|NCT03481634|144588067|OTHER|Descriptive|LS mean difference|36.3|STANDARD_ERROR_OF_MEAN|11.01|||TWO_SIDED|95.0|14.6|57.9|||ANOVA|||Week 36||57.9|14.6|
72529282|NCT03481634|144588067|OTHER|Descriptive|LS mean difference|20.4|STANDARD_ERROR_OF_MEAN|9.97|||TWO_SIDED|95.0|0.7|40.0|||ANOVA|||Week 36||40.0|0.7|
72529283|NCT03481634|144588067|OTHER|Descriptive|LS mean difference|-6.1|STANDARD_ERROR_OF_MEAN|9.19|||TWO_SIDED|95.0|-24.2|11.9|||ANOVA|||Week 40||11.9|-24.2|
72529284|NCT03481634|144588067|OTHER|Descriptive|LS mean difference|-6.5|STANDARD_ERROR_OF_MEAN|9.5|||TWO_SIDED|95.0|-25.2|12.2|||ANOVA|||Week 40||12.2|-25.2|
72529285|NCT03481634|144588067|OTHER|Descriptive|LS mean difference|7.9|STANDARD_ERROR_OF_MEAN|9.33|||TWO_SIDED|95.0|-10.4|26.3|||ANOVA|||Week 44||26.3|-10.4|
72529286|NCT03481634|144588067|OTHER|Descriptive|LS mean difference|1.1|STANDARD_ERROR_OF_MEAN|8.78|||TWO_SIDED|95.0|-16.2|18.3|||ANOVA|||Week 44||18.3|-16.2|
72529287|NCT03481634|144588067|OTHER|Descriptive|LS mean difference|13.6|STANDARD_ERROR_OF_MEAN|9.84|||TWO_SIDED|95.0|-5.8|32.9|||ANOVA|||Week 48||32.9|-5.8|
72529288|NCT03481634|144588067|OTHER|Descriptive|LS mean difference|4.7|STANDARD_ERROR_OF_MEAN|9.26|||TWO_SIDED|95.0|-13.5|23.0|||ANOVA|||Week 48||23.0|-13.5|
72529289|NCT03481634|144588067|OTHER|Descriptive|LS mean difference|4.3|STANDARD_ERROR_OF_MEAN|9.52|||TWO_SIDED|95.0|-14.5|23.0|||ANOVA|||Week 52||23.0|-14.5|
72529290|NCT03481634|144588067|OTHER|Descriptive|LS mean difference|-5.1|STANDARD_ERROR_OF_MEAN|8.78|||TWO_SIDED|95.0|-22.3|12.2|||ANOVA|||Week 52||12.2|-22.3|
72529291|NCT03481634|144588068|OTHER|Descriptive|LS mean difference|1.7|STANDARD_ERROR_OF_MEAN|9.3|||TWO_SIDED|95.0|-16.6|20.0|||ANOVA|||||20.0|-16.6|
72529292|NCT03481634|144588068|OTHER|Descriptive|LS mean difference|-3.5|STANDARD_ERROR_OF_MEAN|8.79|||TWO_SIDED|95.0|-20.7|13.8|||ANOVA|||||13.8|-20.7|
72529293|NCT03481634|144588075|OTHER|Descriptive; Week 28|Difference - %|1.6|||||TWO_SIDED|95.0|-5.3|8.4|||Bootstrap method|||||8.4|-5.3|
72529294|NCT03481634|144588075|OTHER|Descriptive; Week 28|Difference - %|4.1|||||TWO_SIDED|95.0|-2.1|10.3|||Bootstrap method|||||10.3|-2.1|
72529295|NCT03481634|144588075|OTHER|Descriptive; Week 52|Difference - %|5.8|||||TWO_SIDED|95.0|-1.2|12.4|||Bootstrap method|||||12.4|-1.2|
72571784|NCT02912650|144671806|SUPERIORITY_OR_OTHER||LS Mean Difference|0.05||||0.876|TWO_SIDED|95.0|-0.58|0.68|||ANCOVA|||10 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||0.68|-0.58|0.876
72571785|NCT02912650|144671806|SUPERIORITY_OR_OTHER||LS Mean Difference|0.49||||0.134|TWO_SIDED|95.0|-0.15|1.13|||ANCOVA|||10 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||1.13|-0.15|0.134
72571786|NCT02912650|144671806|SUPERIORITY_OR_OTHER||LS Mean Difference|1.17||||0.011|TWO_SIDED|95.0|0.27|2.07|||ANCOVA|||10 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||2.07|0.27|0.011
72369374|NCT03843541|144248701|SUPERIORITY||Mean Difference (Net)|-0.29|STANDARD_DEVIATION|0.783||0.002|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||For the superiority comparisons of NAC vs. placebo, the Bonferroni correction was used.||||0.002
72529296|NCT03481634|144588075|OTHER|Descriptive; Week 52|Difference - %|6.7|||||TWO_SIDED|95.0|0.6|12.9|||Bootstrap method|||||12.9|0.6|
72529297|NCT03481634|144588075|OTHER|Descriptive: Week 76|Difference - %|2.8|||||TWO_SIDED|95.0|-3.9|9.4|||Bootstrap method|||||9.4|-3.9|
72529298|NCT03481634|144588075|OTHER|Descriptive: Week 76|Difference - %|0.7|||||TWO_SIDED|95.0|-5.7|7.0|||Bootstrap method|||||7.0|-5.7|
72529299|NCT03481634|144588075|OTHER|Descriptive: Week 100|Difference - %|1.7|||||TWO_SIDED|95.0|-5.0|8.1|||Bootstrap method|||||8.1|-5.0|
72529300|NCT03481634|144588075|OTHER|Descriptive: Week 100|Difference - %|2.2|||||TWO_SIDED|95.0|-4.0|8.4|||Bootstrap method|||||8.4|-4.0|
72529301|NCT03481634|144588077|OTHER|Descriptive; Week 28|Difference - %|-0.3|||||TWO_SIDED|95.0|-6.4|5.8|||Bootstrap method|||||5.8|-6.4|
72529302|NCT03481634|144588077|OTHER|Descriptive; Week 28|Difference - %|4.6|||||TWO_SIDED|95.0|-1.3|11.0|||Bootstrap method|||||11.0|-1.3|
72529303|NCT03481634|144588077|OTHER|Descriptive; Week 52|Difference - %|-4.2|||||TWO_SIDED|95.0|-10.2|2.2|||Bootstrap method|||||2.2|-10.2|
72529304|NCT03481634|144588077|OTHER|Descriptive; Week 52|Difference - %|3.9|||||TWO_SIDED|95.0|-2.2|10.5|||Bootstrap method|||||10.5|-2.2|
72529305|NCT03481634|144588077|OTHER|Descriptive; Week 72|Difference - %|-9.2|||||TWO_SIDED|95.0|-15.5|-2.8|||Bootstrap method|||||-2.8|-15.5|
72571787|NCT02912650|144671806|SUPERIORITY_OR_OTHER||LS Mean Difference|0.73||||0.112|TWO_SIDED|95.0|-0.17|1.64|||ANCOVA|||10 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||1.64|-0.17|0.112
72529306|NCT03481634|144588077|OTHER|Descriptive; Week 72|Difference - %|-2.3|||||TWO_SIDED|95.0|-8.4|4.4|||Bootstrap method|||||4.4|-8.4|
72529307|NCT03481634|144588077|OTHER|Descriptive; Week 100|Difference - %|-7.7|||||TWO_SIDED|95.0|-14.0|-1.6|||Bootstrap method|||||-1.6|-14.0|
72529308|NCT03481634|144588077|OTHER|Descriptive; Week 100|Difference - %|0.4|||||TWO_SIDED|95.0|-5.7|6.8|||Bootstrap method|||||6.8|-5.7|
72529309|NCT00792922|144588152|SUPERIORITY|Predicted prevalence was estimated in each community using the baseline observed prevalence, treatment arm \& parameters estimated from square root transformed model.For each arm estimated prevalences were averaged.Difference in adjusted mean prevalence for enhanced arm and standard arm was calculated.For confidence intervals for adjusted difference,steps 1 to 4 for 1000 bootstrap samples were repeated.Median of adjusted mean differences, corresponding 2.5 % \& 97.5 % percentiles were reported.|Mean Difference (Final Values)|1.4||||0.22|TWO_SIDED|95.0|-1.0|3.8|||Regression, Linear|||"This is analysis done in Tanzania:~Only the main effect of coverage was analyzed.We hypothesized that increasing the coverage of MDA to greater than 90 % as monitored in children would result in more rapid decline in infection and trachoma compared to usual coverage.Here we are looking at the prevalence of infection."||3.8|-1|0.22
72529310|NCT00792922|144588152|SUPERIORITY|For each community using the baseline observed prevalence, treatment arm and parameters estimated from square root transformed model we estimated predicted prevalence.For each arm we average estimated prevalences.The difference in the adjusted mean prevalence for enhanced arm and standard arm was then calculated.In order to derive the confidence intervals for the adjusted difference, we repeated Steps 1 to 4 for 1000 bootstrap samples.The median of the adjusted mean differences were reported.|Mean Difference (Final Values)|2.6||||0.73|TWO_SIDED|95.0|-0.3|5.3|||Ordinary least squares linear regression|||"This is the analysis done in Tanzania:~Only the main effect of coverage was analyzed.We hypothesized that increasing the coverage of MDA to greater than 90 % as monitored in children would result in more rapid decline in infection and trachoma compared to usual coverage.~Here we are looking at the prevalence of trachoma"||5.3|-0.3|0.73
72529311|NCT00792922|144588152|SUPERIORITY||Median Difference (Final Values)|-4.6||||0.2|TWO_SIDED|95.0|-11.1|1.9|||Regression, Linear|||"This is the statistical analysis for Niger:~We hypothesized that increasing the coverage of MDA to greater than 90 % as monitored in children would result in more rapid decline in infection and trachoma compared to usual coverage.Here we are looking at the prevalence of infection."||1.9|-11.1|0.20
72529312|NCT00792922|144588152|SUPERIORITY||Mean Difference (Final Values)|2.4||||0.6|TWO_SIDED|95.0|-7.7|12.5|||Regression, Linear|||"This is the statistical analysis for Niger:~We hypothesized that increasing the coverage of MDA to greater than 90 % as monitored in children would result in more rapid decline in infection and trachoma compared to usual coverage.Here we are looking at the prevalence of trachoma."||12.5|-7.7|0.60
72529313|NCT00247962|144588154|SUPERIORITY_OR_OTHER||Risk Difference (RD)|22.99|||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
72529314|NCT00247962|144588155|SUPERIORITY_OR_OTHER|||||||0.719|||||||ANCOVA|||baseline||||0.719
72529315|NCT00247962|144588155|SUPERIORITY_OR_OTHER|||||||0.01||95.0|||||ANCOVA|||week 16||||0.010
72571788|NCT02912650|144671806|SUPERIORITY_OR_OTHER||LS Mean Difference|0.44||||0.179|TWO_SIDED|95.0|-0.2|1.08|||ANCOVA|||10 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||1.08|-0.20|0.179
72571789|NCT02912650|144671806|SUPERIORITY_OR_OTHER||LS Mean Difference|0.97||||0.032|TWO_SIDED|95.0|0.09|1.85|||ANCOVA|||11 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||1.85|0.09|0.032
72369375|NCT03843541|144248702|SUPERIORITY|||||||0.239|||||||Stratified Mann-Whitney U Statistic|||||||0.239
72369376|NCT03843541|144248703|SUPERIORITY|||||||0.037|||||||Stratified Mann-Whitney U Statistic|||For the superiority comparisons of NAC vs. placebo, the Bonferroni correction was used.||||0.037
72369377|NCT03843541|144248704|SUPERIORITY|||||||0.093|||||||Stratified Mann Whitney U Statistic|||||||0.093
72369378|NCT03843541|144248704|SUPERIORITY|||||||0.118|||||||Stratified Mann Whitney U Statistic|||||||0.118
72369379|NCT03843541|144248705|SUPERIORITY|||||||0.022|||||||Stratified Mann Whitney U Statistic|||||||0.022
72369380|NCT03843541|144248705|SUPERIORITY|||||||0.11|||||||Stratified Mann Whitney U Statistic|||||||0.110
72369381|NCT03843541|144248706|SUPERIORITY|||||||0.022|||||||Stratified Mann Whitney U Statistic|||||||0.022
72369382|NCT03843541|144248706|SUPERIORITY|||||||0.402|||||||Stratified Mann Whitney U Statistic|||||||0.402
72529316|NCT01469637|144588162|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|If the 90% Confidence Intervals of the geometric mean ratio are wholly contained within the interval (0.80, 1.25), then the hypothesis of a drug interaction will be rejected.|Geometric Mean ratio|1.15|||||TWO_SIDED|90.0|1.12|1.18|||ANOVA|||||1.18|1.12|
72529317|NCT01469637|144588163|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|If the 90% Confidence Intervals of the geometric mean ratio are wholly contained within the interval (0.80, 1.25), then the hypothesis of a drug interaction will be rejected.|Geometric Mean Ratio|1.12|||||TWO_SIDED|90.0|1.09|1.15|||ANOVA|||||1.15|1.09|
72529318|NCT00598585|144588164|SUPERIORITY|unpaired test, the threshold for statistical significance was p= 0.05|||||<|0.05|||||||t-test, 2 sided|||||||< 0.05
72529319|NCT02607735|144588181|SUPERIORITY|The SVR12 rate for the SOF/VEL/VOX group was compared to the performance goal of 85% using a 2-sided exact 1-sample binomial test at the 0.05 significance level.|||||<|0.001|||||||2-sided exact 1-sample binomial test|||||||<0.001
72529320|NCT04111185|144588192|OTHER||||||>|0.05|||||||t-test, 2 sided|||||||>0.05
72529321|NCT02394028|144588201|SUPERIORITY||Difference in rate|1.1||||0.8508|TWO_SIDED|95.0|-10.85|12.56||The multiplicity adjusted p-values are presented.|Cochran-Mantel-Haenszel||Difference in remission rates is adjusted using CMH weights and the 95% CIs use the Newcombes method.|||12.56|-10.85|0.8508
72529322|NCT02394028|144588201|SUPERIORITY||Difference in rate|3.8||||0.5235|TWO_SIDED|95.0|-8.3|15.27||The multiplicity adjusted p-values are presented.|Cochran-Mantel-Haenszel||Difference in remission rates is adjusted using CMH weights and the 95% CIs use the Newcombes method.|||15.27|-8.30|0.5235
72529323|NCT02394028|144588203|SUPERIORITY||Difference in rate|4.9||||0.7908|TWO_SIDED|95.0|-6.26|16.11||The multiplicity adjusted p-values are presented.|Cochran-Mantel-Haenszel||Difference in response rates is adjusted using CMH weights and the 95% CIs use the Newcombes method.|||16.11|-6.26|0.7908
72369383|NCT03843541|144248707|NON_INFERIORITY|Non-inferiority was declared if the one-sided confidence interval was within the interval.|Probability scale treatment difference|0.5||||0.002|TWO_SIDED|97.5|0.43|1.0|||Modified Mann-Whitney U Statistic||The point estimates of treatment differences in probability scale together with associated one-side confidence interval (97.5% or 98.75%) were computed according to Hochberg if both superiority contrasts were found statistically significant.|||1.00|0.43|0.002
72529324|NCT02394028|144588203|SUPERIORITY||Difference in rate|5.8||||0.317|TWO_SIDED|95.0|-5.43|17.05||The multiplicity adjusted p-values are presented.|Cochran-Mantel-Haenszel||Difference in response rates is adjusted using CMH weights and the 95% CIs use the Newcombes method.|||17.05|-5.43|0.3170
72529325|NCT02394028|144588204|SUPERIORITY||Difference in rate|11.3||||0.0088|TWO_SIDED|95.0|2.7|19.65||The multiplicity adjusted p-values are presented.|Cochran-Mantel-Haenszel||Difference in response rates is adjusted using CMH weights and the 95% CIs use the Newcombes method.|||19.65|2.70|0.0088
72529326|NCT02394028|144588205|SUPERIORITY||Difference in rate|11.5||||0.0026|TWO_SIDED|95.0|4.11|18.83||The multiplicity adjusted p-values are presented.|Cochran-Mantel-Haenszel||Difference in response rates is adjusted using CMH weights and the 95% CIs use the Newcombes method.|||18.83|4.11|0.0026
72529327|NCT02394028|144588207|SUPERIORITY||Difference in rate|3.1||||1|TWO_SIDED|95.0|-8.02|13.45||The multiplicity adjusted p-values are presented.|Cochran-Mantel-Haenszel||Difference in remission rates are adjusted using CMH weights and the 95% CIs use the Newcombes method.|||13.45|-8.02|1
72529328|NCT02394028|144588207|SUPERIORITY||Difference in rate|2.3||||0.7908|TWO_SIDED|95.0|-8.78|12.56||The multiplicity adjusted p-values are presented.|Cochran-Mantel-Haenszel||Difference in remission rates are adjusted using CMH weights and the 95% CIs use the Newcombes method.|||12.56|-8.78|0.7908
72529329|NCT02394028|144588209|SUPERIORITY||Difference in rate|1.6||||1|TWO_SIDED|95.0|-6.51|9.73||The multiplicity adjusted p-values are presented.|Cochran-Mantel-Haenszel||Difference in remission rates are adjusted using CMH weights and the 95% CIs use the Newcombes method.|||9.73|-6.51|1
72529330|NCT02394028|144588209|SUPERIORITY||Difference in rate|6.5||||0.5235|TWO_SIDED|95.0|-2.24|15.16||The multiplicity adjusted p-values are presented.|Cochran-Mantel-Haenszel||Difference in remission rates are adjusted using CMH weights and the 95% CIs use the Newcombes method.|||15.16|-2.24|0.5235
72625564|NCT01968980|144780512|SUPERIORITY_OR_OTHER||LS Mean Difference|-46.8|STANDARD_ERROR_OF_MEAN|2.67|||TWO_SIDED|95.0|-52.1|-41.6||||||Week 24: LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region.||-41.6|-52.1|
72625565|NCT01968980|144780512|SUPERIORITY_OR_OTHER||LS Mean Difference|-40.5|STANDARD_ERROR_OF_MEAN|2.53|||TWO_SIDED|95.0|-45.5|-35.5||||||Week 52: LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region.||-35.5|-45.5|
72529331|NCT02394028|144588210|SUPERIORITY||Difference in LSM|-0.5||||0.311|TWO_SIDED|90.0|-1.4|0.3|||MMRM|||Bowel Domain Score||0.3|-1.4|0.3110
72529332|NCT02394028|144588211|SUPERIORITY||Difference in LSM|0.2||||1|TWO_SIDED|95.0|-0.5|0.9||The multiplicity adjusted p-values are presented.|MMRM|||Functional Domain Scale||0.9|-0.5|1
72529333|NCT02394028|144588211|SUPERIORITY||Difference in LSM|0.0||||1|TWO_SIDED|95.0|-0.7|0.7||The multiplicity adjusted p-values are presented.|MMRM|||Functional Domain Score||0.7|-0.7|1
72529334|NCT02394028|144588211|SUPERIORITY||Difference in LSM|0.1||||1|TWO_SIDED|95.0|-0.8|0.9||The multiplicity adjusted p-values are presented.|MMRM|||Bowel Domain Score||0.9|-0.8|1
72529335|NCT02394028|144588211|SUPERIORITY||Difference in LSM|-0.3||||1|TWO_SIDED|95.0|-1.1|0.5||The multiplicity adjusted p-values are presented.|MMRM|||Bowel Domain Score||0.5|-1.1|1
72529336|NCT02394028|144588212|SUPERIORITY||Difference in rate|17.3||||0.0677|TWO_SIDED|95.0|3.52|30.27||The multiplicity adjusted p-values are presented.|Cochran-Mantel-Haenszel||Difference in remission rates is adjusted using CMH weights and the 95% CIs use the Newcombes method.|||30.27|3.52|0.0677
72529337|NCT02394028|144588213|SUPERIORITY||Difference in rates|18.6||||0.048|TWO_SIDED|95.0|11.07|25.96||The multiplicity adjusted p-values are presented.|Cochran-Mantel-Haenszel||Difference in remission rates is adjusted using CMH weights and the 95% CIs use the Newcombes method.|||25.96|11.07|0.0480
72529338|NCT02394028|144588214|SUPERIORITY||Difference in rates|13.5||||0.121|TWO_SIDED|95.0|-2.9|29.94|||Cochran-Mantel-Haenszel||Difference in response rates is adjusted using CMH weights and the 95% CIs use the Newcombes method.|||29.94|-2.90|0.1210
72625566|NCT01968980|144780513|SUPERIORITY_OR_OTHER||LS Mean Difference|-35.1|STANDARD_ERROR_OF_MEAN|12.58|||TWO_SIDED|95.0|-59.8|-10.3||||||Week 24: LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region.||-10.3|-59.8|
72529339|NCT02394028|144588215|SUPERIORITY||Difference in rates|6.2||||0.048|TWO_SIDED|95.0|0.54|11.93||The multiplicity adjusted p-values are presented.|Cochran-Mantel-Haenszel||Difference in remission rates is adjusted using CMH weights and the 95% CIs use the Newcombes method.|||11.93|0.54|0.0480
72529340|NCT02394028|144588216|SUPERIORITY||Difference in rates|11.2||||0.0677|TWO_SIDED|95.0|3.04|19.24||The multiplicity adjusted p-values are presented.|Cochran-Mantel-Haenszel||Difference in response rates is adjusted using CMH weights and the 95% CIs use the Newcombes method.|||19.24|3.04|0.0677
72529341|NCT02394028|144588217|SUPERIORITY||Difference in rates|16.2||||0.0035|TWO_SIDED|95.0|8.96|23.31||Nominal p-value, no adjustment for multiplicity performed.|Cochran-Mantel-Haenszel||Difference in remission rates is adjusted using CMH weights and the 95% CIs use the Newcombes method.|||23.31|8.96|0.0035
72529342|NCT02394028|144588218|SUPERIORITY||Difference in LSM|-0.3||||0.4009|TWO_SIDED|95.0|-0.9|0.4||The multiplicity adjusted p-values are presented.|MMRM|||Functional Symptoms Domain||0.4|-0.9|0.4009
72529343|NCT02394028|144588218|SUPERIORITY||Difference in LSM|-0.3||||0.4009|TWO_SIDED|95.0|-1.0|0.4||The multiplicity adjusted p-values are presented.|MMRM|||Bowel Symptoms Domain||0.4|-1.0|0.4009
72529344|NCT00742391|144588228|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Cochran-Mantel-Haenszel|||||||<0.0001
72529345|NCT00742391|144588229|SUPERIORITY_OR_OTHER|||||||0.0001||95.0|||||Cochran-Mantel-Haenszel|||||||0.0001
72529346|NCT01981096|144588232|SUPERIORITY|||||||0.011||||||The a priori threshold was alpha = .05.|ANCOVA|Adjusted for age and baseline pain levels||This analysis represents the between group comparisons (i.e., FIT Teens vs. CBT) from baseline assessment to the 3-month follow-up, the primary endpoint of the trial.||||.011
72529347|NCT01981096|144588233|SUPERIORITY|||||||0.055||||||The a priori threshold was alpha = .05.|ANCOVA|Adjusted for age and baseline pain levels||This analysis represents the between group comparisons (i.e., FIT Teens vs. CBT) from baseline assessment to the 3-month follow-up, the primary endpoint of the trial.||||.055
72529348|NCT01225211|144588238|SUPERIORITY_OR_OTHER||LS Mean difference|-2.679||||0.267|TWO_SIDED|95.0|-7.484|2.125|||ANCOVA|||||2.125|-7.484|0.267
72529349|NCT01225211|144588238|SUPERIORITY_OR_OTHER||LS Mean difference|-9.676|||<|0.001|TWO_SIDED|95.0|-14.801|-4.551|||ANCOVA|||||-4.551|-14.801|<0.001
72529350|NCT01225211|144588239|SUPERIORITY_OR_OTHER||LS Mean difference|-1.306||||0.68|TWO_SIDED|95.0|-7.565|4.953|||ANCOVA|||||4.953|-7.565|0.680
72529351|NCT01225211|144588239|SUPERIORITY_OR_OTHER||LS Mean difference|-2.67||||0.409|TWO_SIDED|95.0|-9.053|3.712|||ANCOVA|||||3.712|-9.053|0.409
72529352|NCT01225211|144588239|SUPERIORITY_OR_OTHER||LS Mean difference|-4.526||||0.161|TWO_SIDED|95.0|-10.888|1.835|||ANCOVA|||||1.835|-10.888|0.161
72625567|NCT01968980|144780513|SUPERIORITY_OR_OTHER||LS Mean Difference|-15.3|STANDARD_ERROR_OF_MEAN|5.58|||TWO_SIDED|95.0|-26.3|-4.4||||||Week 52: LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region.||-4.4|-26.3|
72529353|NCT01225211|144588239|SUPERIORITY_OR_OTHER||LS Mean difference|-2.867||||0.396|TWO_SIDED|95.0|-9.543|3.81|||ANCOVA|||||3.810|-9.543|0.396
72529354|NCT01225211|144588239|SUPERIORITY_OR_OTHER||LS Mean difference|-3.78||||0.365|TWO_SIDED|95.0|-12.028|4.467|||ANCOVA|||||4.467|-12.028|0.365
72529355|NCT01225211|144588240|SUPERIORITY_OR_OTHER||LS Mean difference|0.6||||0.5978|TWO_SIDED|95.0|-1.66|2.86|||Mixed Model Repeated Measure (MMRM)|||||2.86|-1.66|0.5978
72529356|NCT02355665|144588262|SUPERIORITY||Estimated Success Rate Ratio|2.0||||0.021|TWO_SIDED|95.0|1.1|3.66||The significance threshold level was 0.05 (two-sided).|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by study site and number of cigarettes smoked per day at baseline (\<20 per day vs ≥20 per day).|Estimated Success Rate Ratio = Nicotine/Placebo|The null hypothesis was no difference in continuous smoking abstinence rates between treatments. The alternative hypothesis was a difference in continuous smoking abstinence rates between treatments.||3.66|1.10|0.021
72529357|NCT02355665|144588263|SUPERIORITY||Estimated Success Rate Ratio|3.04||||0.004|TWO_SIDED|95.0|1.39|6.68||The significance threshold level was 0.05 (two-sided).|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by study site and number of cigarettes smoked per day at baseline (\<20 per day vs ≥20 per day).|Estimated Success Rate Ratio = Nicotine/Placebo|The null hypothesis was no difference in continuous smoking abstinence rates between treatments. The alternative hypothesis was a difference in continuous smoking abstinence rates between treatments.||6.68|1.39|0.004
72529358|NCT02355665|144588264|SUPERIORITY||Estimated Success Rate Ratio|2.87||||0.011|TWO_SIDED|95.0|1.23|6.71||The significance threshold level was 0.05 (two-sided).|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by study site and number of cigarettes smoked per day at baseline (\<20 per day vs ≥20 per day).|Estimated Success Rate Ratio = Nicotine/Placebo|The null hypothesis was no difference in continuous smoking abstinence rates between treatments. The alternative hypothesis was a difference in continuous smoking abstinence rates between treatments.||6.71|1.23|0.011
72529359|NCT02355665|144588265|SUPERIORITY||Estimated Success Rate Ratio|1.66||||0.04|TWO_SIDED|95.0|1.02|2.71||The significance threshold level was 0.05 (two-sided).|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by study site and number of cigarettes smoked per day at baseline (\<20 per day vs ≥20 per day).|Estimated Success Rate Ratio = Nicotine/Placebo|The null hypothesis was no difference in continuous smoking abstinence rates between treatments. The alternative hypothesis was a difference in continuous smoking abstinence rates between treatments.||2.71|1.02|0.040
72529360|NCT02355665|144588266|SUPERIORITY||Estimated Success Rate Ratio|2.09||||0.023|TWO_SIDED|95.0|1.09|3.98||The significance threshold level was 0.05 (two-sided).|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by study site and number of cigarettes smoked per day at baseline (\<20 per day vs ≥20 per day).|Estimated Success Rate Ratio = Nicotine/Placebo|The null hypothesis was no difference in continuous smoking abstinence rates between treatments. The alternative hypothesis was a difference in continuous smoking abstinence rates between treatments.||3.98|1.09|0.023
72407676|NCT03217136|144323765|OTHER|The Miettinen \& Nurminen method was used.|Difference in Percentage|2.9|||||TWO_SIDED|95.0|-12.9|9.9||||||Difference in Percentage (C/T+MTZ minus MERO)||9.9|-12.9|
72529361|NCT02355665|144588267|SUPERIORITY||Estimated Success Rate Ratio|2.91||||0.006|TWO_SIDED|95.0|1.32|6.42||The significance threshold level was 0.05 (two-sided).|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by study site and number of cigarettes smoked per day at baseline (\<20 per day vs ≥20 per day).|Estimated Success Rate Ratio = Nicotine/Placebo|The null hypothesis was no difference in continuous smoking abstinence rates between treatments. The alternative hypothesis was a difference in continuous smoking abstinence rates between treatments.||6.42|1.32|0.006
72529362|NCT02355665|144588268|SUPERIORITY||Estimated Success Rate Ratio|2.66||||0.013|TWO_SIDED|95.0|1.2|5.92||The significance threshold level was 0.05 (two-sided).|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by study site and number of cigarettes smoked per day at baseline (\<20 per day vs ≥20 per day).|Estimated Success Rate Ratio = Nicotine/Placebo|The null hypothesis was no difference in continuous smoking abstinence rates between treatments. The alternative hypothesis was a difference in continuous smoking abstinence rates between treatments.||5.92|1.20|0.013
72529363|NCT02355665|144588269|SUPERIORITY||Estimated Mean Difference|-0.02||||0.847|TWO_SIDED|95.0|-0.64|0.6||The significance threshold level was 0.05 (two-sided).|Wilcoxon (Mann-Whitney)||Estimated Mean Difference = Nicotine - Placebo|The null hypothesis was no difference in distribution of the ratings of desire/urge to smoke between treatments. The alternative hypothesis was a difference in distribution of the ratings of desire/urge to smoke between treatments.||0.60|-0.64|0.847
72529364|NCT02355665|144588270|SUPERIORITY||Estimated Mean Difference|-0.1||||0.861|TWO_SIDED|95.0|-0.62|0.42||The significance threshold level was 0.05 (two-sided).|Wilcoxon (Mann-Whitney)||Estimated Mean Difference = Nicotine - Placebo|The null hypothesis was no difference in distribution of the ratings of desire/urge to smoke between treatments. The alternative hypothesis was a difference in distribution of the ratings of desire/urge to smoke between treatments.||0.42|-0.62|0.861
72529365|NCT02355665|144588271|SUPERIORITY||Estimated Mean Difference|-0.19||||0.266|TWO_SIDED|95.0|-0.61|0.24||The significance threshold level was 0.05 (two-sided).|Wilcoxon (Mann-Whitney)||Estimated Mean Difference = Nicotine - Placebo|The null hypothesis was no difference in distribution of the ratings of desire/urge to smoke between treatments. The alternative hypothesis was a difference in distribution of the ratings of desire/urge to smoke between treatments.||0.24|-0.61|0.266
72529366|NCT02355665|144588272|SUPERIORITY||Estimated Mean Difference|0.09||||0.487|TWO_SIDED|95.0|-0.38|0.55||The significance threshold level was 0.05 (two-sided).|Wilcoxon (Mann-Whitney)||Estimated Mean Difference = Nicotine - Placebo|The null hypothesis was no difference in distribution of the ratings of desire/urge to smoke between treatments. The alternative hypothesis was a difference in distribution of the ratings of desire/urge to smoke between treatments.||0.55|-0.38|0.487
72529367|NCT02355665|144588273|SUPERIORITY||Estimated Mean Difference|-0.11||||0.433|TWO_SIDED|95.0|-0.65|0.43||The significance threshold level was 0.05 (two-sided).|Wilcoxon (Mann-Whitney)||Estimated Mean Difference = Nicotine - Placebo|The null hypothesis was no difference in distribution of the ratings of irritability/frustration/anger between treatments. The alternative hypothesis was a difference in distribution of the ratings of irritability/frustration/anger between treatments.||0.43|-0.65|0.433
72529368|NCT02355665|144588274|SUPERIORITY||Estimated Mean Difference|-0.58||||0.022|TWO_SIDED|95.0|-1.15|-0.01||The significance threshold level was 0.05 (two-sided).|Wilcoxon (Mann-Whitney)||Estimated Mean Difference = Nicotine - Placebo|The null hypothesis was no difference in distribution of the ratings of irritability/frustration/anger between treatments. The alternative hypothesis was a difference in distribution of the ratings of irritability/frustration/anger between treatments.||-0.01|-1.15|0.022
72529369|NCT02355665|144588275|SUPERIORITY||Estimated Mean Difference|0.0||||0.665|TWO_SIDED|95.0|-0.5|0.49||The significance threshold level was 0.05 (two-sided).|Wilcoxon (Mann-Whitney)||Estimated Mean Difference = Nicotine - Placebo|The null hypothesis was no difference in distribution of the ratings of irritability/frustration/anger between treatments. The alternative hypothesis was a difference in distribution of the ratings of irritability/frustration/anger between treatments.||0.49|-0.50|0.665
72529370|NCT02355665|144588276|SUPERIORITY||Estimated Mean Difference|-0.1||||0.3|TWO_SIDED|95.0|-0.51|0.31||The significance threshold level was 0.05 (two-sided).|Wilcoxon (Mann-Whitney)||Estimated Mean Difference = Nicotine - Placebo|The null hypothesis was no difference in distribution of the ratings of irritability/frustration/anger between treatments. The alternative hypothesis was a difference in distribution of the ratings of irritability/frustration/anger between treatments.||0.31|-0.51|0.300
72529371|NCT02355665|144588277|SUPERIORITY||Estimated Mean Difference|-0.17||||0.754|TWO_SIDED|95.0|-0.78|0.43||The significance threshold level was 0.05 (two-sided).|Wilcoxon (Mann-Whitney)||Estimated Mean Difference = Nicotine - Placebo|The null hypothesis was no difference in distribution of the ratings of restlessness between treatments. The alternative hypothesis was a difference in distribution of the ratings of restlessness between treatments.||0.43|-0.78|0.754
72529372|NCT02355665|144588278|SUPERIORITY||Estimated Mean Difference|-0.41||||0.116|TWO_SIDED|95.0|-0.89|0.08||The significance threshold level was 0.05 (two-sided).|Wilcoxon (Mann-Whitney)||Estimated Mean Difference = Nicotine - Placebo|The null hypothesis was no difference in distribution of the ratings of restlessness between treatments. The alternative hypothesis was a difference in distribution of the ratings of restlessness between treatments.||0.08|-0.89|0.116
72529373|NCT02355665|144588279|SUPERIORITY||Estimated Mean Difference|-0.14||||0.392|TWO_SIDED|95.0|-0.47|0.2||The significance threshold level was 0.05 (two-sided).|Wilcoxon (Mann-Whitney)||Estimated Mean Difference = Nicotine - Placebo|The null hypothesis was no difference in distribution of the ratings of restlessness between treatments. The alternative hypothesis was a difference in distribution of the ratings of restlessness between treatments.||0.20|-0.47|0.392
72571790|NCT02912650|144671806|SUPERIORITY_OR_OTHER||LS Mean Difference|0.06||||0.85|TWO_SIDED|95.0|-0.56|0.67|||ANCOVA|||11 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||0.67|-0.56|0.850
72407677|NCT03217136|144323766|OTHER|The difference in percentage was based on the Miettinen \& Nurminen method stratified by age group with Cochran-Mantel-Haenszel (CMH) weights. If there was a zero count in any class of the stratum, the groups with the lower count were pooled with its near age group stratum in the model.|Difference in Percentage|-14.3|||||TWO_SIDED|95.0|-26.67|4.93||||||Difference in Percentage (C/T+MTZ minus MERO)||4.93|-26.67|
72625568|NCT01968980|144780514|SUPERIORITY_OR_OTHER||LS Mean Difference|5.9|STANDARD_ERROR_OF_MEAN|1.42|||TWO_SIDED|95.0|3.1|8.7||||||Week 24: LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region.||8.7|3.1|
72407678|NCT03217136|144323767|OTHER|The difference in percentage was based on the Miettinen \& Nurminen method stratified by age group with Cochran-Mantel-Haenszel (CMH) weights. If there was a zero count in any class of the stratum, the groups with the lower count were pooled with its near age group stratum in the model.|Difference in Percentage|-19.1|||||TWO_SIDED|95.0|-30.18|-2.89||||||Difference in Percentage (C/T+MTZ minus MERO)||-2.89|-30.18|
72407679|NCT03217136|144323768|OTHER|The difference in percentage was based on the Miettinen \& Nurminen method stratified by age group with Cochran-Mantel-Haenszel (CMH) weights. If there was a zero count in any class of the stratum, the groups with the lower count were pooled with its near age group stratum in the model.|Difference in Percentage|-11.2|||||TWO_SIDED|95.0|-23.66|9.61||||||Difference in Percentage (C/T+MTZ minus MERO)||9.61|-23.66|
72529374|NCT02355665|144588280|SUPERIORITY||Estimated Mean Difference|-0.23||||0.179|TWO_SIDED|95.0|-0.59|0.13||The significance threshold level was 0.05 (two-sided).|Wilcoxon (Mann-Whitney)||Estimated Mean Difference = Nicotine - Placebo|The null hypothesis was no difference in distribution of the ratings of restlessness between treatments. The alternative hypothesis was a difference in distribution of the ratings of restlessness between treatments.||0.13|-0.59|0.179
72407680|NCT03217136|144323769|OTHER|The difference in percentage was based on the Miettinen \& Nurminen method stratified by age group with Cochran-Mantel-Haenszel (CMH) weights. If there was a zero count in any class of the stratum, the groups with the lower count were pooled with its near age group stratum in the model.|Difference in Percentage|-16.3|||||TWO_SIDED|95.0|-27.59|1.39||||||Difference in Percentage (C/T+MTZ minus MERO)||1.39|-27.59|
72407681|NCT03192150|144323770|SUPERIORITY|Statistical hypotheses testing for the primary efficacy endpoint was two-sided and performed using a significance (alpha) level of 0.05.|||||<|0.0001||||||P-values were from a Chi-Square test (with continuity correction) of differences between treatments in the proportion of participants with ACC Grade 0 who did not receive rescue medication versus all other grades combined.|Chi-squared, Corrected|A Fisher's exact test was used if 1 or more of the cells had an expected frequency of ≤ 5.||||||< 0.0001
72529375|NCT02355665|144588281|SUPERIORITY||Estimated Mean Difference|0.01||||0.925|TWO_SIDED|95.0|-0.44|0.47||The significance threshold level was 0.05 (two-sided).|Wilcoxon (Mann-Whitney)||Estimated Mean Difference = Nicotine - Placebo|The null hypothesis was no difference in distribution of the ratings of difficulty concentrating between treatments. The alternative hypothesis was a difference in distribution of the ratings of difficulty concentrating between treatments.||0.47|-0.44|0.925
72529376|NCT02355665|144588282|SUPERIORITY||Estimated Mean Difference|-0.21||||0.325|TWO_SIDED|95.0|-0.66|0.24||The significance threshold level was 0.05 (two-sided).|Wilcoxon (Mann-Whitney)||Estimated Mean Difference = Nicotine - Placebo|The null hypothesis was no difference in distribution of the ratings of difficulty concentrating between treatments. The alternative hypothesis was a difference in distribution of the ratings of difficulty concentrating between treatments.||0.24|-0.66|0.325
72529377|NCT02355665|144588283|SUPERIORITY||Estimated Mean Difference|0.13||||0.891|TWO_SIDED|95.0|-0.24|0.51||The significance threshold level was 0.05 (two-sided).|Wilcoxon (Mann-Whitney)||Estimated Mean Difference = Nicotine - Placebo|The null hypothesis was no difference in distribution of the ratings of difficulty concentrating between treatments. The alternative hypothesis was a difference in distribution of the ratings of difficulty concentrating between treatments.||0.51|-0.24|0.891
72529378|NCT02355665|144588284|SUPERIORITY||Estimated Mean Difference|-0.11||||0.721|TWO_SIDED|95.0|-0.48|0.25||The significance threshold level was 0.05 (two-sided).|Wilcoxon (Mann-Whitney)||Estimated Mean Difference = Nicotine - Placebo|The null hypothesis was no difference in distribution of the ratings of difficulty concentrating between treatments. The alternative hypothesis was a difference in distribution of the ratings of difficulty concentrating between treatments.||0.25|-0.48|0.721
72529379|NCT02355665|144588285|SUPERIORITY||Estimated Mean Difference|-0.03||||0.608|TWO_SIDED|95.0|-0.54|0.49||The significance threshold level was 0.05 (two-sided).|Wilcoxon (Mann-Whitney)||Estimated Mean Difference = Nicotine - Placebo|The null hypothesis was no difference in distribution of the ratings of anxiety between treatments. The alternative hypothesis was a difference in distribution of the ratings of anxiety between treatments.||0.49|-0.54|0.608
72529380|NCT02355665|144588286|SUPERIORITY||Estimated Mean Difference|-0.63||||0.014|TWO_SIDED|95.0|-1.16|-0.09||The significance threshold level was 0.05 (two-sided).|Wilcoxon (Mann-Whitney)||Estimated Mean Difference = Nicotine - Placebo|The null hypothesis was no difference in distribution of the ratings of anxiety between treatments. The alternative hypothesis was a difference in distribution of the ratings of anxiety between treatments.||-0.09|-1.16|0.014
72529381|NCT02355665|144588287|SUPERIORITY||Estimated Mean Difference|0.04||||0.9|TWO_SIDED|95.0|-0.3|0.38||The significance threshold level was 0.05 (two-sided).|Wilcoxon (Mann-Whitney)||Estimated Mean Difference = Nicotine - Placebo|The null hypothesis was no difference in distribution of the ratings of anxiety between treatments. The alternative hypothesis was a difference in distribution of the ratings of anxiety between treatments.||0.38|-0.30|0.900
72529382|NCT02355665|144588288|SUPERIORITY||Estimated Mean Difference|-0.06||||0.731|TWO_SIDED|95.0|-0.44|0.31||The significance threshold level was 0.05 (two-sided).|Wilcoxon (Mann-Whitney)||Estimated Mean Difference = Nicotine - Placebo|The null hypothesis was no difference in distribution of the ratings of anxiety between treatments. The alternative hypothesis was a difference in distribution of the ratings of anxiety between treatments.||0.31|-0.44|0.731
72529383|NCT02355665|144588289|SUPERIORITY||Estimated Mean Difference|0.04||||0.635|TWO_SIDED|95.0|-0.28|0.36||The significance threshold level was 0.05 (two-sided).|Wilcoxon (Mann-Whitney)||Estimated Mean Difference = Nicotine - Placebo|The null hypothesis was no difference in distribution of the ratings of dysphoric or depressed mood between treatments. The alternative hypothesis was a difference in distribution of the ratings of dysphoric or depressed mood between treatments.||0.36|-0.28|0.635
72529384|NCT02355665|144588290|SUPERIORITY||Estimated Mean Difference|-0.05||||0.273|TWO_SIDED|95.0|-0.42|0.32||The significance threshold level was 0.05 (two-sided).|Wilcoxon (Mann-Whitney)||Estimated Mean Difference = Nicotine - Placebo|The null hypothesis was no difference in distribution of the ratings of dysphoric or depressed mood between treatments. The alternative hypothesis was a difference in distribution of the ratings of dysphoric or depressed mood between treatments.||0.32|-0.42|0.273
72571791|NCT02912650|144671806|SUPERIORITY_OR_OTHER||LS Mean Difference|0.32||||0.311|TWO_SIDED|95.0|-0.3|0.95|||ANCOVA|||11 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||0.95|-0.30|0.311
72571792|NCT02912650|144671806|SUPERIORITY_OR_OTHER||LS Mean Difference|0.91||||0.043|TWO_SIDED|95.0|0.03|1.79|||ANCOVA|||11 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||1.79|0.03|0.043
72571793|NCT02912650|144671806|SUPERIORITY_OR_OTHER||LS Mean Difference|0.64||||0.154||95.0|-0.24|1.53|||ANCOVA|||11 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||1.53|-0.24|0.154
72571794|NCT02912650|144671806|SUPERIORITY_OR_OTHER||LS Mean Difference|0.26||||0.408|TWO_SIDED|95.0|-0.36|0.89|||ANCOVA|||11 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||0.89|-0.36|0.408
72625569|NCT01968980|144780514|SUPERIORITY_OR_OTHER||LS Mean Difference|2.9|STANDARD_ERROR_OF_MEAN|1.53|||TWO_SIDED|95.0|-0.1|5.9||||||Week 52: LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region.||5.9|-0.1|
72625570|NCT01968980|144780515|SUPERIORITY_OR_OTHER||LS Mean Difference|-17.0|STANDARD_ERROR_OF_MEAN|4.22|||TWO_SIDED|95.0|-25.3|-8.7||||||Week 12: LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region.||-8.7|-25.3|
72529385|NCT02355665|144588291|SUPERIORITY||Estimated Mean Difference|-0.06||||0.879|TWO_SIDED|95.0|-0.4|0.28||The significance threshold level was 0.05 (two-sided).|Wilcoxon (Mann-Whitney)||Estimated Mean Difference = Nicotine - Placebo|The null hypothesis was no difference in distribution of the ratings of dysphoric or depressed mood between treatments. The alternative hypothesis was a difference in distribution of the ratings of dysphoric or depressed mood between treatments.||0.28|-0.40|0.879
72571795|NCT02912650|144671806|SUPERIORITY_OR_OTHER||LS Mean Difference|0.81||||0.065|TWO_SIDED|95.0|-0.05|1.68|||ANCOVA|||12 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||1.68|-0.05|0.065
72529386|NCT02355665|144588292|SUPERIORITY||Estimated Mean Difference|0.02||||0.823|TWO_SIDED|95.0|-0.28|0.32||The significance threshold level was 0.05 (two-sided).|Wilcoxon (Mann-Whitney)||Estimated Mean Difference = Nicotine - Placebo|The null hypothesis was no difference in distribution of the ratings of dysphoric or depressed mood between treatments. The alternative hypothesis was a difference in distribution of the ratings of dysphoric or depressed mood between treatments.||0.32|-0.28|0.823
72571796|NCT02912650|144671806|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.05||||0.862|TWO_SIDED|95.0|-0.66|0.55|||ANCOVA|||12 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||0.55|-0.66|0.862
72571797|NCT02912650|144671806|SUPERIORITY_OR_OTHER||LS Mean Difference|0.29||||0.352|TWO_SIDED|95.0|-0.32|0.9|||ANCOVA|||12 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||0.90|-0.32|0.352
72571798|NCT02912650|144671806|SUPERIORITY_OR_OTHER||LS Mean Difference|0.87||||0.049|TWO_SIDED|95.0|0.0|1.73|||ANCOVA|||12 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||1.73|0.00|0.049
72571799|NCT02912650|144671806|SUPERIORITY_OR_OTHER||LS Mean Difference|0.52||||0.239|TWO_SIDED|95.0|-0.35|1.39|||ANCOVA|||12 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||1.39|-0.35|0.239
72571800|NCT02912650|144671806|SUPERIORITY_OR_OTHER||LS Mean Difference|0.34||||0.27|TWO_SIDED|95.0|-0.27|0.96|||ANCOVA|||12 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||0.96|-0.27|0.270
72571801|NCT02912650|144671807|SUPERIORITY_OR_OTHER||LS Mean Difference|0.15||||0.031|TWO_SIDED|95.0|0.01|0.28|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.28|0.01|0.031
72571802|NCT02912650|144671807|SUPERIORITY_OR_OTHER||LS Mean Difference|0.03||||0.527|TWO_SIDED|95.0|-0.06|0.12|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.12|-0.06|0.527
72571803|NCT02912650|144671807|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.04||||0.386|TWO_SIDED|95.0|-0.14|0.05|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.05|-0.14|0.386
72571804|NCT02912650|144671807|SUPERIORITY_OR_OTHER||LS Mean Difference|0.12||||0.084|TWO_SIDED|95.0|-0.02|0.25|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.25|-0.02|0.084
72625571|NCT01968980|144780515|SUPERIORITY_OR_OTHER||LS Mean Difference|-17.4|STANDARD_ERROR_OF_MEAN|4.9|||TWO_SIDED|95.0|-27.0|-7.8||||||Week 24: LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region.||-7.8|-27.0|
72625572|NCT01968980|144780515|SUPERIORITY_OR_OTHER||LS Mean Difference|-9.5|STANDARD_ERROR_OF_MEAN|5.04|||TWO_SIDED|95.0|-19.4|0.4||||||Week 52: LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region.||0.4|-19.4|
72571805|NCT02912650|144671807|SUPERIORITY_OR_OTHER||LS Mean Difference|0.19||||0.006|TWO_SIDED|95.0|0.06|0.32|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.32|0.06|0.006
72571806|NCT02912650|144671807|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.07||||0.135|TWO_SIDED|95.0|-0.17|0.02|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.02|-0.17|0.135
72571807|NCT02912650|144671807|SUPERIORITY_OR_OTHER||LS Mean Difference|0.54|||<|0.001|TWO_SIDED|95.0|0.34|0.73|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.73|0.34|<0.001
72571808|NCT02912650|144671807|SUPERIORITY_OR_OTHER||LS Mean Difference|0.13||||0.062|TWO_SIDED|95.0|-0.01|0.27|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.27|-0.01|0.062
72571809|NCT02912650|144671807|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0||||0.977|TWO_SIDED|95.0|-0.14|0.14|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.14|-0.14|0.977
72625573|NCT01968980|144780516|SUPERIORITY_OR_OTHER||LS Mean Difference|5.3|STANDARD_ERROR_OF_MEAN|1.25|||TWO_SIDED|95.0|2.9|7.8||||||Week 12: LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region.||7.8|2.9|
72571810|NCT02912650|144671807|SUPERIORITY_OR_OTHER||LS Mean Difference|0.41|||<|0.001|TWO_SIDED|95.0|0.21|0.6|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.60|0.21|<0.001
72625574|NCT01968980|144780516|SUPERIORITY_OR_OTHER||LS Mean Difference|4.6|STANDARD_ERROR_OF_MEAN|1.1|||TWO_SIDED|95.0|2.5|6.8||||||Week 24: LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region.||6.8|2.5|
72625575|NCT01968980|144780516|SUPERIORITY_OR_OTHER||LS Mean Difference|3.0|STANDARD_ERROR_OF_MEAN|1.22|||TWO_SIDED|95.0|0.5|5.4||||||Week 52: LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region.||5.4|0.5|
72571811|NCT02912650|144671807|SUPERIORITY_OR_OTHER||LS Mean Difference|0.53|||<|0.001|TWO_SIDED|95.0|0.34|0.73|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.73|0.34|<0.001
72571812|NCT02912650|144671807|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.13||||0.069|TWO_SIDED|95.0|-0.27|0.01|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.01|-0.27|0.069
72571813|NCT02912650|144671807|SUPERIORITY_OR_OTHER||LS Mean Difference|1.14|||<|0.001|TWO_SIDED|95.0|0.9|1.38|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.38|0.90|<0.001
72571814|NCT02912650|144671807|SUPERIORITY_OR_OTHER||LS Mean Difference|0.29|||<|0.001|TWO_SIDED|95.0|0.12|0.46|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.46|0.12|<0.001
72571815|NCT02912650|144671807|SUPERIORITY_OR_OTHER||LS Mean Difference|0.22||||0.011|TWO_SIDED|95.0|0.05|0.39|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.39|0.05|0.011
72571816|NCT02912650|144671807|SUPERIORITY_OR_OTHER||LS Mean Difference|0.85|||<|0.001|TWO_SIDED|95.0|0.61|1.09|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.09|0.61|< 0.001
72571817|NCT02912650|144671807|SUPERIORITY_OR_OTHER||LS Mean Difference|0.92|||<|0.001|TWO_SIDED|95.0|0.67|1.16|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.16|0.67|<0.001
72571818|NCT02912650|144671807|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.07||||0.427|TWO_SIDED|95.0|-0.24|0.1|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.10|-0.24|0.427
72571819|NCT02912650|144671807|SUPERIORITY_OR_OTHER||LS Mean Difference|1.36|||<|0.001|TWO_SIDED|95.0|1.11|1.6|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.60|1.11|<0.001
72571820|NCT02912650|144671807|SUPERIORITY_OR_OTHER||LS Mean Difference|0.27||||0.002|TWO_SIDED|95.0|0.1|0.44|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.44|0.10|0.002
72571821|NCT02912650|144671807|SUPERIORITY_OR_OTHER||LS Mean Difference|0.41|||<|0.001|TWO_SIDED|95.0|0.23|0.58|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.58|0.23|<0.001
72571822|NCT02912650|144671807|SUPERIORITY_OR_OTHER||LS Mean Difference|1.09|||<|0.001|TWO_SIDED|95.0|0.84|1.33|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.33|0.84|<0.001
72571823|NCT02912650|144671807|SUPERIORITY_OR_OTHER||LS Mean Difference|0.95|||<|0.001|TWO_SIDED|95.0|0.7|1.2|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.20|0.70|<0.001
72571824|NCT02912650|144671807|SUPERIORITY_OR_OTHER||LS Mean Difference|0.14||||0.123|TWO_SIDED|95.0|-0.04|0.31|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.31|-0.04|0.123
72571825|NCT02912650|144671807|SUPERIORITY_OR_OTHER||LS Mean Difference|1.4|||<|0.001|TWO_SIDED|95.0|1.14|1.67|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.67|1.14|<0.001
72571826|NCT02912650|144671807|SUPERIORITY_OR_OTHER||LS Mean Difference|0.24||||0.012|TWO_SIDED|95.0|0.05|0.42|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.42|0.05|0.012
72529387|NCT02355665|144588293|SUPERIORITY||Estimated Mean Difference|0.0||||0.804|TWO_SIDED|95.0|-0.4|0.4||The significance threshold level was 0.05 (two-sided).|Wilcoxon (Mann-Whitney)||Estimated Mean Difference = Nicotine - Placebo|The null hypothesis was no difference in distribution of the ratings of insomnia between treatments. The alternative hypothesis was a difference in distribution of the ratings of insomnia between treatments.||0.40|-0.40|0.804
72529388|NCT02355665|144588294|SUPERIORITY||Estimated Mean Difference|0.13||||0.438|TWO_SIDED|95.0|-0.3|0.57||The significance threshold level was 0.05 (two-sided).|Wilcoxon (Mann-Whitney)||Estimated Mean Difference = Nicotine - Placebo|The null hypothesis was no difference in distribution of the ratings of insomnia between treatments. The alternative hypothesis was a difference in distribution of the ratings of insomnia between treatments.||0.57|-0.30|0.438
72529389|NCT02355665|144588295|SUPERIORITY||Estimated Mean Difference|-0.08||||0.517|TWO_SIDED|95.0|-0.44|0.28||The significance threshold level was 0.05 (two-sided).|Wilcoxon (Mann-Whitney)||Estimated Mean Difference = Nicotine - Placebo|The null hypothesis was no difference in distribution of the ratings of insomnia between treatments. The alternative hypothesis was a difference in distribution of the ratings of insomnia between treatments.||0.28|-0.44|0.517
72529390|NCT02355665|144588296|SUPERIORITY||Estimated Mean Difference|-0.42||||0.027|TWO_SIDED|95.0|-0.77|-0.06||The significance threshold level was 0.05 (two-sided).|Wilcoxon (Mann-Whitney)||Estimated Mean Difference = Nicotine - Placebo|The null hypothesis was no difference in distribution of the ratings of insomnia between treatments. The alternative hypothesis was a difference in distribution of the ratings of insomnia between treatments.||-0.06|-0.77|0.027
72529391|NCT02355665|144588297|SUPERIORITY||Estimated Mean Difference|-0.3||||0.105|TWO_SIDED|95.0|-0.93|0.33||The significance threshold level was 0.05 (two-sided).|Wilcoxon (Mann-Whitney)||Estimated Mean Difference = Nicotine - Placebo|The null hypothesis was no difference in distribution of the ratings of increased appetite between treatments. The alternative hypothesis was a difference in distribution of the ratings of increased appetite between treatments.||0.33|-0.93|0.105
72529392|NCT02355665|144588298|SUPERIORITY||Estimated Mean Difference|-0.04||||0.604|TWO_SIDED|95.0|-0.6|0.51||The significance threshold level was 0.05 (two-sided).|Wilcoxon (Mann-Whitney)||Estimated Mean Difference = Nicotine - Placebo|The null hypothesis was no difference in distribution of the ratings of increased appetite between treatments. The alternative hypothesis was a difference in distribution of the ratings of increased appetite between treatments.||0.51|-0.60|0.604
72529393|NCT02355665|144588299|SUPERIORITY||Estimated Mean Difference|-0.35||||0.194|TWO_SIDED|95.0|-0.93|0.24||The significance threshold level was 0.05 (two-sided).|Wilcoxon (Mann-Whitney)||Estimated Mean Difference = Nicotine - Placebo|The null hypothesis was no difference in distribution of the ratings of increased appetite between treatments. The alternative hypothesis was a difference in distribution of the ratings of increased appetite between treatments.||0.24|-0.93|0.194
72529394|NCT02355665|144588300|SUPERIORITY||Estimated Mean Difference|-0.11||||0.502|TWO_SIDED|95.0|-0.62|0.4||The significance threshold level was 0.05 (two-sided).|Wilcoxon (Mann-Whitney)||Estimated Mean Difference = Nicotine - Placebo|The null hypothesis was no difference in distribution of the ratings of increased appetite between treatments. The alternative hypothesis was a difference in distribution of the ratings of increased appetite between treatments.||0.40|-0.62|0.502
72529395|NCT02355665|144588301|SUPERIORITY||Estimated Mean Difference|-0.56||||0.483|TWO_SIDED|95.0|-2.84|1.73||The significance threshold level was 0.05 (two-sided).|Wilcoxon (Mann-Whitney)||Estimated Mean Difference = Nicotine - Placebo|The null hypothesis was no difference in distribution of aggregated withdrawal scores between treatments. The alternative hypothesis was a difference in distribution of aggregated withdrawal scores between treatments.||1.73|-2.84|0.483
72529396|NCT02355665|144588302|SUPERIORITY||Estimated Mean Difference|-1.79||||0.102|TWO_SIDED|95.0|-4.24|0.67||The significance threshold level was 0.05 (two-sided).|Wilcoxon (Mann-Whitney)||Estimated Mean Difference = Nicotine - Placebo|The null hypothesis was no difference in distribution of aggregated withdrawal scores between treatments. The alternative hypothesis was a difference in distribution of aggregated withdrawal scores between treatments.||0.67|-4.24|0.102
72529397|NCT02355665|144588303|SUPERIORITY||Estimated Mean Difference|-0.45||||0.532|TWO_SIDED|95.0|-2.27|1.38||The significance threshold level was 0.05 (two-sided).|Wilcoxon (Mann-Whitney)||Estimated Mean Difference = Nicotine - Placebo|The null hypothesis was no difference in distribution of aggregated withdrawal scores between treatments. The alternative hypothesis was a difference in distribution of aggregated withdrawal scores between treatments.||1.38|-2.27|0.532
72529398|NCT02355665|144588304|SUPERIORITY||Estimated Mean Difference|-1.01||||0.354|TWO_SIDED|95.0|-2.93|0.91||The significance threshold level was 0.05 (two-sided).|Wilcoxon (Mann-Whitney)||Estimated Mean Difference = Nicotine - Placebo|The null hypothesis was no difference in distribution of aggregated withdrawal scores between treatments. The alternative hypothesis was a difference in distribution of aggregated withdrawal scores between treatments.||0.91|-2.93|0.354
72529399|NCT02355665|144588473|SUPERIORITY||Least Squares Mean Difference|0.99|STANDARD_ERROR_OF_MEAN|1.679||0.558|TWO_SIDED|95.0|-2.42|4.41||The significance threshold level was 0.05 (two-sided).|ANCOVA|Treatment, baseline smoking category, study site, and baseline weight were factors.|Least Squares Mean Difference = Nicotine - Placebo|The null hypothesis was no difference in mean change from baseline in body weight between treatments. The alternative hypothesis was a difference in mean change from baseline in body weight between treatments.||4.41|-2.42|0.558
72529400|NCT02355665|144588474|SUPERIORITY||Least Squares Mean Difference|3.04|STANDARD_ERROR_OF_MEAN|3.409||0.383|TWO_SIDED|95.0|-4.03|10.11||The significance threshold level was 0.05 (two-sided).|ANCOVA|Treatment, baseline smoking category, study site, and baseline weight were factors.|Least Squares Mean Difference = Nicotine - Placebo|The null hypothesis was no difference in mean change from baseline in body weight between treatments. The alternative hypothesis was a difference in mean change from baseline in body weight between treatments.||10.11|-4.03|0.383
72529401|NCT02355665|144588475|SUPERIORITY||Least Squares Mean Difference|7.13|STANDARD_ERROR_OF_MEAN|4.573||0.138|TWO_SIDED|95.0|-2.56|16.83||The significance threshold level was 0.05 (two-sided).|ANCOVA|Treatment, baseline smoking category, study site, and baseline weight were factors.|Least Squares Mean Difference = Nicotine - Placebo|The null hypothesis was no difference in mean change from baseline in body weight between treatments. The alternative hypothesis was a difference in mean change from baseline in body weight between treatments.||16.83|-2.56|0.138
72625576|NCT01968980|144780517|SUPERIORITY_OR_OTHER||LS Mean Difference|0.7|STANDARD_ERROR_OF_MEAN|1.5|||TWO_SIDED|95.0|-2.3|3.6||||||Week 12: LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region.||3.6|-2.3|
72529402|NCT01084096|144588513|SUPERIORITY|Trial powered to detect a 30% reduction in 28-d NM among \<5th %tile for birth weight infants. We used an intention-to-treat approach, with a model-based adaptation of the permutation test. We fitted an individual-level linear model with 28-d NM by site and randomization strata, nested within site, and computed the residual for each individual and mean cluster-level residuals. Next, we used an ANOVA model to test for trt differences between mean residuals for intervention and control clusters.|Risk Ratio (RR)|0.96||||0.65|TWO_SIDED|95.0|0.87|1.06|||t-test, 2 sided|Cluster-level with 62 degrees of freedom \[101 clusters-37 strata-2 treatment groups\].|Calculated from generalized linear models accounting for the cluster-level variance and adjusted for randomization strata. Each stratum corresponds to 2-4 clusters within the site with equal distribution to treatment and control arms.|||1.06|0.87|0.65
72529403|NCT01084096|144588514|SUPERIORITY||Risk Difference (RD)|0.3546|||<|0.0001|TWO_SIDED|95.0|0.3299|0.3792|||Cochran-Mantel-Haenszel|P-values were calculated from Cochran-Mantel-Haenszel test controlling for randomization strata.|Risk difference represents risk in the intervention clusters minus the risk in the control clusters.|The trial was powered to detect a 30% reduction in 28-day neonatal mortality among infants born at less than the 5th percentile of birth weight, based on previous research and an expected increase from 10% to 50% in the use of antenatal corticosteroids among women at risk of preterm birth in the intervention group.||0.3792|0.3299|<0.0001
72529404|NCT01084096|144588515|OTHER|Descriptive analysis.|Odds Ratio (OR)|1.45|||<|0.0001|TWO_SIDED|95.0|1.33|1.58||P-values were calculated from Cochran-Mantel-Haenszel test controlling for randomization strata.|Cochran-Mantel-Haenszel|||||1.58|1.33|<0.0001
72529405|NCT01084096|144588517|SUPERIORITY||Risk Ratio (RR)|1.12||||0.0127|TWO_SIDED|95.0|1.02|1.22||P-value calculated from a generalized linear model with generalized estimating equations to estimate parameters while controlling for cluster correlations. Model-generated p value was adjusted for randomization strata.|Generalized linear model with GEE||Relative risk calculated from a generalized linear model with generalized estimating equations to estimate parameters while controlling for cluster correlations. Model-generated measure of risk was adjusted for randomization strata.|||1.22|1.02|0.0127
72529406|NCT01084096|144588518|OTHER|Descriptive analysis.|Risk Ratio (RR)|1.11||||0.0181|TWO_SIDED|95.0|1.02|1.22||P-value calculated from a generalized linear model with generalized estimating equations to estimate parameters while controlling for cluster correlations. Model-generated p value was adjusted for randomization strata.|Generalized linear model with GEE||Relative risk calculated from a generalized linear model with generalized estimating equations to estimate parameters while controlling for cluster correlations. Model-generated measure of risk was adjusted for randomization strata.|||1.22|1.02|0.0181
72529407|NCT04450394|144588537|NON_INFERIORITY|The non-inferiority margin is 0.4%. Non-inferiority is achieved if the upper limit of the 90% Confidence Interval is below 0.4.|LS Mean Difference|0.06|||||TWO_SIDED|90.0|-0.11|0.24||||||||0.24|-0.11|
72529408|NCT00836342|144588541|SUPERIORITY_OR_OTHER|||||||0.31|||||||t-test, 2 sided|||Null hypothesis: There is no difference in mean carotenoid levels between subjects with a history of squamous cell carcinom and control subjects.||||0.31
72529409|NCT00836342|144588542|SUPERIORITY_OR_OTHER|||||||0.49|||||||t-test, 2 sided|||||||0.49
72529410|NCT00836342|144588543|SUPERIORITY_OR_OTHER|||||||0.09||95.0|||||t-test, 2 sided|||||||0.09
72529411|NCT02155660|144588545|SUPERIORITY||Rate ratio|0.85||||0.0638|TWO_SIDED|95.0|0.71|1.01|||Negative binomial|Model includes treatment group, EOS cohort, region, background therapy, number of exacerbations in the previous year.||||1.01|0.71|0.0638
72529412|NCT02155660|144588545|SUPERIORITY||Rate ratio|1.04||||0.6575|TWO_SIDED|95.0|0.88|1.23|||Negative binomial|Model includes treatment group, EOS cohort, region, background therapy, number of exacerbations in the previous year.||||1.23|0.88|0.6575
72529413|NCT02155660|144588545|SUPERIORITY||Rate ratio|0.93||||0.3988|TWO_SIDED|95.0|0.78|1.1|||Negative binomial|Model includes treatment group, EOS cohort, region, background therapy, number of exacerbations in the previous year.||||1.10|0.78|0.3988
72529414|NCT02155660|144588546|SUPERIORITY||Rate ratio|1.04||||0.7564|TWO_SIDED|95.0|0.82|1.32|||Negative binomial|Model includes treatment group, region, background therapy, number of exacerbations in the previous year.||||1.32|0.82|0.7564
72529415|NCT02155660|144588546|SUPERIORITY||Rate ratio|1.08||||0.5573|TWO_SIDED|95.0|0.84|1.37|||Negative binomial|Model includes treatment group, region, background therapy, number of exacerbations in the previous year.||||1.37|0.84|0.5573
72529416|NCT02155660|144588546|SUPERIORITY||Rate ratio|1.02||||0.8644|TWO_SIDED|95.0|0.8|1.3|||Negative binomial|Model includes treatment group, region, background therapy, number of exacerbations in the previous year.||||1.30|0.80|0.8644
72529417|NCT02155660|144588547|SUPERIORITY||Mean Difference (Final Values)|0.015||||0.5043|TWO_SIDED|95.0|-0.029|0.059|||Mixed Models Analysis|Model includes treatment group, baseline FEV1 value, EOS cohort, region, background therapy, visit, and treatment by visit interaction.||||0.059|-0.029|0.5043
72529418|NCT02155660|144588547|SUPERIORITY||Mean Difference (Final Values)|-0.007||||0.7691|TWO_SIDED|95.0|-0.051|0.037|||Mixed Models Analysis|Model includes treatment group, baseline FEV1 value, EOS cohort, region, background therapy, visit, and treatment by visit interaction.||||0.037|-0.051|0.7691
72529419|NCT02155660|144588547|SUPERIORITY||Mean Difference (Final Values)|0.02||||0.3767|TWO_SIDED|95.0|-0.024|0.064|||Mixed Models Analysis|Model includes treatment group, baseline FEV1 value, EOS cohort, region, background therapy, visit, and treatment by visit interaction.||||0.064|-0.024|0.3767
72529420|NCT02155660|144588548|SUPERIORITY||Mean Difference (Final Values)|-1.011||||0.3636|TWO_SIDED|95.0|-3.192|1.171|||Mixed Models Analysis|Model includes treatment group, baseline SGRQ score, EOS cohort, region, background therapy, visit, and treatment by visit interaction.||||1.171|-3.192|0.3636
72529421|NCT02155660|144588548|SUPERIORITY||Mean Difference (Final Values)|-1.388||||0.2106|TWO_SIDED|95.0|-3.562|0.786|||Mixed Models Analysis|Model includes treatment group, baseline SGRQ score, EOS cohort, region, background therapy, visit, and treatment by visit interaction.||||0.786|-3.562|0.2106
72529422|NCT02155660|144588548|SUPERIORITY||Mean Difference (Final Values)|-0.602||||0.5851|TWO_SIDED|95.0|-2.763|1.56|||Mixed Models Analysis|Model includes treatment group, baseline SGRQ score, EOS cohort, region, background therapy, visit, and treatment by visit interaction.||||1.560|-2.763|0.5851
72625577|NCT01968980|144780517|SUPERIORITY_OR_OTHER||LS Mean Difference|0.6|STANDARD_ERROR_OF_MEAN|1.31|||TWO_SIDED|95.0|-1.9|3.2||||||Week 24: LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region.||3.2|-1.9|
72625578|NCT01968980|144780517|SUPERIORITY_OR_OTHER||LS Mean Difference|0.8|STANDARD_ERROR_OF_MEAN|1.39|||TWO_SIDED|95.0|-1.9|3.6||||||Week 52: LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region.||3.6|-1.9|
72625579|NCT01968980|144780518|SUPERIORITY_OR_OTHER||LS Mean Difference|-17.0|STANDARD_ERROR_OF_MEAN|4.22|||TWO_SIDED|95.0|-25.3|-8.7||||||Week 12: LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region.||-8.7|-25.3|
72529423|NCT02155660|144588549|SUPERIORITY||Mean Difference (Final Values)|0.09||||0.8525|TWO_SIDED|95.0|-0.82|0.99|||Mixed Models Analysis|Model includes treatment group, baseline CAT total score, EOS cohort, region, background therapy, visit, and treatment by visit interaction.||||0.99|-0.82|0.8525
72529424|NCT02155660|144588549|SUPERIORITY||Mean Difference (Final Values)|-0.01||||0.987|TWO_SIDED|95.0|-0.91|0.89|||Mixed Models Analysis|Model includes treatment group, baseline CAT total score, EOS cohort, region, background therapy, visit, and treatment by visit interaction.||||0.89|-0.91|0.9870
72529425|NCT02155660|144588549|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.8204|TWO_SIDED|95.0|-1.0|0.79|||Mixed Models Analysis|Model includes treatment group, baseline CAT total score, EOS cohort, region, background therapy, visit, and treatment by visit interaction.||||0.79|-1.00|0.8204
72529426|NCT02155660|144588550|SUPERIORITY||Mean Difference (Final Values)|-0.4||||0.2636|TWO_SIDED|95.0|-1.102|0.301|||Mixed Models Analysis|Model includes treatment group, baseline total score, EOS cohort, region, background therapy, visit, and treatment by visit interaction.||||0.301|-1.102|0.2636
72529427|NCT02155660|144588550|SUPERIORITY||Mean Difference (Final Values)|-0.296||||0.4087|TWO_SIDED|95.0|-0.998|0.406|||Mixed Models Analysis|Model includes treatment group, baseline total score, EOS cohort, region, background therapy, visit, and treatment by visit interaction.||||0.406|-0.998|0.4087
72529428|NCT02155660|144588550|SUPERIORITY||Mean Difference (Final Values)|-0.425||||0.2336|TWO_SIDED|95.0|-1.125|0.275|||Mixed Models Analysis|Model includes treatment group, baseline total score, EOS cohort, region, background therapy, visit, and treatment by visit interaction.||||0.275|-1.125|0.2336
72529429|NCT02155660|144588551|SUPERIORITY||Mean Difference (Final Values)|-0.642||||0.0012|TWO_SIDED|95.0|-1.029|-0.254|||Mixed Models Analysis|Model includes treatment group, baseline rescue med. use, EOS cohort, region, background therapy, visit, and treatment by visit interaction.||||-0.254|-1.029|0.0012
72529430|NCT02155660|144588551|SUPERIORITY||Mean Difference (Final Values)|-0.34||||0.0852|TWO_SIDED|95.0|-0.727|0.047|||Mixed Models Analysis|Model includes treatment group, baseline rescue med. use, EOS cohort, region, background therapy, visit, and treatment by visit interaction.||||0.047|-0.727|0.0852
72625580|NCT01968980|144780518|SUPERIORITY_OR_OTHER||LS Mean Difference|-17.4|STANDARD_ERROR_OF_MEAN|4.9|||TWO_SIDED|95.0|-27.0|-7.8||||||Week 24: LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region.||-7.8|-27.0|
72625581|NCT01968980|144780518|SUPERIORITY_OR_OTHER||LS Mean Difference|-9.5|STANDARD_ERROR_OF_MEAN|5.04|||TWO_SIDED|95.0|-19.4|0.4||||||Week 52: LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region.||0.4|-19.4|
72529431|NCT02155660|144588551|SUPERIORITY||Mean Difference (Final Values)|-0.364||||0.065|TWO_SIDED|95.0|-0.75|0.023|||Mixed Models Analysis|Model includes treatment group, baseline rescue med. use, EOS cohort, region, background therapy, visit, and treatment by visit interaction.||||0.023|-0.750|0.0650
72529432|NCT02155660|144588552|SUPERIORITY||Mean Difference (Final Values)|-0.041||||0.0415|TWO_SIDED|95.0|-0.081|-0.002|||Mixed Models Analysis|Model includes treatment group, baseline prop. of nights awakens., EOS cohort, region, background therapy, visit, and treatment by visit interaction.||||-0.002|-0.081|0.0415
72529433|NCT02155660|144588552|SUPERIORITY||Mean Difference (Final Values)|-0.055||||0.0069|TWO_SIDED|95.0|-0.094|-0.015|||Mixed Models Analysis|Model includes treatment group, baseline prop. of nights awakens., EOS cohort, region, background therapy, visit, and treatment by visit interaction.||||-0.015|-0.094|0.0069
72529434|NCT02155660|144588552|SUPERIORITY||Mean Difference (Final Values)|-0.026||||0.2008|TWO_SIDED|95.0|-0.065|0.014|||Mixed Models Analysis|Model includes treatment group, baseline prop. of nights awakens., EOS cohort, region, background therapy, visit, and treatment by visit interaction.||||0.014|-0.065|0.2008
72529435|NCT02155660|144588556|SUPERIORITY||Rate ratio|0.98||||0.8158|TWO_SIDED|95.0|0.81|1.18|||Negative binomial|Model includes treatment group, EOS cohort, region, background therapy, number of exacerbations in the previous year.||||1.18|0.81|0.8158
72529436|NCT02155660|144588556|SUPERIORITY||Rate ratio|0.98||||0.8378|TWO_SIDED|95.0|0.82|1.18|||Negative binomial|Model includes treatment group, EOS cohort, region, background therapy, number of exacerbations in the previous year.||||1.18|0.82|0.8378
72529437|NCT02155660|144588556|SUPERIORITY||Rate ratio|0.92||||0.3759|TWO_SIDED|95.0|0.76|1.11|||Negative binomial|Model includes treatment group, EOS cohort, region, background therapy, number of exacerbations in the previous year.||||1.11|0.76|0.3759
72529438|NCT02155660|144588557|SUPERIORITY||Odds Ratio (OR)|1.02||||0.9141|TWO_SIDED|95.0|0.76|1.36|||Cochran-Mantel-Haenszel|CMH test controlling for EOS cohort, region, and background therapy.||Proportion of participants with \>=1 COPD exacerbation.||1.36|0.76|0.9141
72407682|NCT03192150|144323771|SUPERIORITY|Statistical hypotheses testing for the secondary efficacy endpoints were two-sided and performed using a significance (alpha) level of 0.05.|Odds Ratio (OR)|2.311||||0.0054|TWO_SIDED|95.0|1.311|4.074||P-values were from a Chi-Square test with continuity correction.|Chi-squared, Corrected|A Fisher's exact test was used if ≥ 1 of the cells had an expected frequency of ≤ 5.||Statistical analysis of proportion of participants who achieved a pain score of 0 on the VAS on Day 1||4.074|1.311|0.0054
72407683|NCT03192150|144323771|SUPERIORITY|Statistical hypotheses testing for the secondary efficacy endpoints were two-sided and performed using a significance (alpha) level of 0.05.|Odds Ratio (OR)|3.581|||<|0.0001|TWO_SIDED|95.0|1.967|6.519||P-values were from a Chi-Square test with continuity correction.|Chi-squared, Corrected|A Fisher's exact test was used if ≥ 1 of the cells had an expected frequency of ≤ 5.||Statistical analysis of proportion of participants who achieved a pain score of 0 on the VAS on Day 8||6.519|1.967|< 0.0001
72407684|NCT03192150|144323771|SUPERIORITY|Statistical hypotheses testing for the secondary efficacy endpoints were two-sided and performed using a significance (alpha) level of 0.05.|Odds Ratio (OR)|3.503|||<|0.0001|TWO_SIDED|95.0|1.909|6.426||P-values were from a Chi-Square test with continuity correction.|Chi-squared, Corrected|A Fisher's exact test was used if ≥ 1 of the cells had an expected frequency of ≤ 5.||Statistical analysis of proportion of participants who achieved a pain score of 0 on the VAS on Day 15||6.426|1.909|< 0.0001
72529439|NCT02155660|144588557|SUPERIORITY||Odds Ratio (OR)|1.39||||0.0323|TWO_SIDED|95.0|1.03|1.87|||Cochran-Mantel-Haenszel|CMH test controlling for EOS cohort, region, and background therapy.||Proportion of participants with \>=1 COPD exacerbation.||1.87|1.03|0.0323
72529440|NCT02155660|144588557|SUPERIORITY||Odds Ratio (OR)|1.1||||0.5109|TWO_SIDED|95.0|0.82|1.48|||Cochran-Mantel-Haenszel|CMH test controlling for EOS cohort, region, and background therapy.||Proportion of participants with \>=1 COPD exacerbation.||1.48|0.82|0.5109
72529441|NCT02155660|144588559|SUPERIORITY||Rate ratio|0.68||||0.0287|TWO_SIDED|95.0|0.49|0.96|||Negative binomial|Model includes treatment group, EOS cohort, region, background therapy, previous year exacerbations associated with hospitalization (Y/N).||||0.96|0.49|0.0287
72529442|NCT02155660|144588559|SUPERIORITY||Rate ratio|0.89||||0.4631|TWO_SIDED|95.0|0.65|1.22|||Negative binomial|Model includes treatment group, EOS cohort, region, background therapy, previous year exacerbations associated with hospitalization (Y/N).||||1.22|0.65|0.4631
72529443|NCT02155660|144588559|SUPERIORITY||Rate ratio|0.67||||0.0185|TWO_SIDED|95.0|0.48|0.94|||Negative binomial|Model includes treatment group, EOS cohort, region, background therapy, previous year exacerbations associated with hospitalization (Y/N).||||0.94|0.48|0.0185
72529444|NCT01192139|144588564|NON_INFERIORITY_OR_EQUIVALENCE|BE was concluded if the 90% CIs for the test-to-reference ratios of geometric means were entirely contained within 0.800 to 1.250 for both Cmax and AUC0-inf of saxagliptin|Ratio of Geometric Least Squares Means|1.039|||||TWO_SIDED|90.0|1.011|1.068|||||Ratio=Treatment B/Treatment A. Geometric least squares means values are presented in other statistical analysis entries.|If there was no difference between the bioavailabilities of saxagliptin from the FDC tablet versus saxagliptin from coadministration of a saxagliptin tablet and a metformin XR tablet under fed conditions, then 24 subjects would have provided 99% power to conclude bioequivalence (BE) with respect to Cmax and AUC0-inf. If there was a 5% difference, then 24 subjects would have provided 94% and 99% power to conclude BE with respect to Cmax and AUC0-inf, respectively.||1.068|1.011|
72529445|NCT01192139|144588564|NON_INFERIORITY_OR_EQUIVALENCE|Lack of food effect was concluded if the 90% CIs for the test-to-reference ratios of geometric means were entirely contained within (80%, 125%) for both Cmax and AUC(INF) of saxagliptin and metformin.|Ratio of Least Squares Means|1.078|||||TWO_SIDED|90.0|1.049|1.108|||||Ratio=Treatment B/Treatment C. Geometric least squares means values are presented in other statistical analysis entries.|||1.108|1.049|
72529446|NCT01192139|144588564|SUPERIORITY_OR_OTHER||Geometric least squares mean (ng*hr/mL)|104.65||||||95.0||||||||Geometric least squares means for treatment A||||
72529447|NCT01192139|144588564|SUPERIORITY_OR_OTHER||Geometric least squares mean (ng*hr/mL)|108.74||||||95.0||||||||Geometric least squares means for treatment B||||
72625582|NCT01968980|144780519|SUPERIORITY_OR_OTHER||LS Mean Difference|-78.8|STANDARD_ERROR_OF_MEAN|3.75|||TWO_SIDED|95.0|-86.2|-71.4||||||LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region.||-71.4|-86.2|
72407685|NCT03192150|144323771|SUPERIORITY|Statistical hypotheses testing for the secondary efficacy endpoints were two-sided and performed using a significance (alpha) level of 0.05.|Odds Ratio (OR)|3.659|||<|0.0001|TWO_SIDED|95.0|1.987|6.736||P-values were from a Chi-Square test with continuity correction.|Chi-squared, Corrected|A Fisher's exact test was used if ≥ 1 of the cells had an expected frequency of ≤ 5.||Statistical analysis of proportion of participants who achieved a pain score of 0 on the VAS on Day 18||6.736|1.987|< 0.0001
72625583|NCT01968980|144780520|SUPERIORITY_OR_OTHER||LS Mean Difference|-83.2|STANDARD_ERROR_OF_MEAN|4.15|||TWO_SIDED|95.0|-91.3|-75.0||||||LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region.||-75.0|-91.3|
72529448|NCT01192139|144588564|SUPERIORITY_OR_OTHER||Geometric least squares mean (ng*hr/mL)|100.84||||||95.0||||||||Geometric least squares mean for treatment C||||
72529449|NCT01192139|144588566|SUPERIORITY_OR_OTHER||Ratio of Geometric Least Squares Mean|1.039|||||TWO_SIDED|90.0|1.011|1.068|||||Ratio = Treatment B/Treatment A. Geometric least squares means values are presented in other statistical analysis entries.|||1.068|1.011|
72529450|NCT01192139|144588566|SUPERIORITY_OR_OTHER||Ratio of Geometric Least Squares Means|1.08|||||TWO_SIDED|90.0|1.051|1.11|||||Ratio=Treatment B/Treatment C. Geometric least squares means values are presented in other statistical analysis entries.|||1.110|1.051|
72529451|NCT01192139|144588566|SUPERIORITY_OR_OTHER||Geometric least squares mean (ng*hr/mL)|102.84||||||95.0||||||||Geometric least squares mean for treatment A||||
72529452|NCT01192139|144588566|SUPERIORITY_OR_OTHER||Geometric least squares mean (ng*hr/mL)|106.89||||||95.0||||||||Geometric least squares mean for treatment B||||
72529453|NCT01192139|144588566|SUPERIORITY_OR_OTHER||Geometric least squares mean (ng*hr/mL)|98.99||||||95.0||||||||Geometric least squares mean for treatment C||||
72625584|NCT01968980|144780521|SUPERIORITY_OR_OTHER||LS Mean Difference|-87.0|STANDARD_ERROR_OF_MEAN|4.25|||TWO_SIDED|95.0|-95.4|-78.7||||||LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region.||-78.7|-95.4|
72625585|NCT01968980|144780522|SUPERIORITY_OR_OTHER||LS Mean Difference|-53.8|STANDARD_ERROR_OF_MEAN|2.71|||TWO_SIDED|95.0|-59.2|-48.5||||||LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region.||-48.5|-59.2|
72407686|NCT03192150|144323771|SUPERIORITY|Statistical hypotheses testing for the secondary efficacy endpoints were two-sided and performed using a significance (alpha) level of 0.05.|Odds Ratio (OR)|2.952||||0.0008|TWO_SIDED|95.0|1.596|5.462||P-values were from a Chi-Square test with continuity correction.|Chi-squared, Corrected|A Fisher's exact test was used if ≥ 1 of the cells had an expected frequency of ≤ 5.||Statistical analysis of proportion of participants who achieved a pain score of 0 on the VAS on Day 29||5.462|1.596|0.0008
72407687|NCT01420302|144323782|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
72529454|NCT01192139|144588567|NON_INFERIORITY_OR_EQUIVALENCE|BE was concluded if the 90% CIs for the test-to-reference ratios of geometric means were entirely contained within 0.800 to 1.250 for both Cmax and AUC0-inf of saxagliptin.|Ratio of Geometric Least Squares Means|1.021|||||TWO_SIDED|90.0|0.94|1.109|||||Ratio=Treatment B/Treatment A. Geometric least squares means values are presented in other statistical analysis entries.|If there was no difference between the bioavailabilities of saxagliptin from the FDC tablet versus saxagliptin from coadministration of a saxagliptin tablet and a metformin XR tablet under fed conditions, then 24 subjects would have provided 99% power to conclude bioequivalence (BE) with respect to Cmax and AUC0-inf. If there was a 5% difference, then 24 subjects would have provided 94% and 99% power to conclude BE with respect to Cmax and AUC0-inf, respectively.||1.109|0.940|
72529455|NCT01192139|144588567|NON_INFERIORITY_OR_EQUIVALENCE|Lack of food effect was concluded if the fed to fasted ratios of geometric means were entirely contained within (80%, 125%) for both Cmax and AUC(INF) of saxagliptin.|Ratio of Geometric Least Squares Means|0.949|||||TWO_SIDED|90.0|0.873|1.031|||||Ratio = Treatment B/Treatment C. Geometric least squares means values are presented in other statistical analysis entries.|||1.031|0.873|
72529456|NCT01192139|144588567|SUPERIORITY_OR_OTHER||Geometric least squares mean (ng*hr/mL)|25.68||||||95.0||||||||Geometric least squares mean for treatment A||||
72529457|NCT01192139|144588567|SUPERIORITY_OR_OTHER||Geometric least squares mean (ng*hr/mL)|26.21||||||95.0||||||||Geometric least squares mean for treatment B||||
72529458|NCT01192139|144588567|SUPERIORITY_OR_OTHER||Geometric least squares mean (ng*hr/mL)|27.63||||||95.0||||||||Geometric least squares mean for treatment C||||
72529459|NCT01192139|144588576|NON_INFERIORITY_OR_EQUIVALENCE|BE concluded if the 90% CIs for the test-to-reference ratios of geometric means were entirely contained within (80%, 125%) for both Cmax and AUC(INF) of saxagliptin and metformin.|Ratio of Least Squares Geometric Means|0.915|||||TWO_SIDED|90.0|0.836|1.002|||||Ratio = Treatment B/Treatment A. Geometric least squares means values are presented in other statistical analysis entries.|If there was no difference between the bioavailabilities of metformin from the FDC tablet versus metformin from coadministration of a saxagliptin tablet and a metformin XR tablet under fed conditions, then 24 subjects would have provided 99% power to conclude BE with respect to Cmax and AUC0-inf. If there was a 5% difference, then 24 subjects would have provided 96% and 97% power to conclude BE with respect to Cmax and AUC0-inf, respectively.||1.002|0.836|
72529460|NCT01192139|144588576|NON_INFERIORITY_OR_EQUIVALENCE|lack of food effect concluded if the 90% CIs for the test-to-reference ratios of geometric means were entirely contained within (80%, 125%) for both Cmax and AUC(INF) of saxagliptin and metformin.|Ratio of Geometric LS Mean and 90% CI|1.01|||||TWO_SIDED|90.0|0.918|1.111|||||Ratio = Treatment B/Treatment C. Geometric least squares means values are presented in other statistical analysis entries.|||1.111|0.918|
72529461|NCT01192139|144588576|SUPERIORITY_OR_OTHER||Geometric least squares mean (ng*hr/mL)|5542.2||||||95.0||||||||Geometric least squares means for treatment A||||
72529462|NCT01192139|144588576|SUPERIORITY_OR_OTHER||Geometric least squares mean (ng*hr/mL)|5072.9||||||95.0||||||||Geometric least squares mean for treatment B||||
72529463|NCT01192139|144588576|SUPERIORITY_OR_OTHER||Geometric least squares mean (ng*hr/mL)|5023.3||||||95.0||||||||Geometric least squares mean for treatment C||||
72529464|NCT01192139|144588577|SUPERIORITY_OR_OTHER||Ratio of Geometric Least Squares Mean|0.92|||||TWO_SIDED|90.0|0.854|0.992|||||Ratio=Treatment B/Treatment A. Geometric least squares means values are presented in other statistical analysis entries.|||0.992|0.854|
72407688|NCT05446909|144323803|SUPERIORITY||||||>|0.05|||||||ANOVA|||||||>0.05
72529465|NCT01192139|144588577|SUPERIORITY_OR_OTHER||Ratio of Geometric Least Squares Means|1.025|||||TWO_SIDED|95.0|0.951|1.105|||||Ratio=Treatment B/Treatment C. Geometric least squares means values are presented in other statistical analysis entries.|||1.105|0.951|
72529466|NCT01192139|144588577|SUPERIORITY_OR_OTHER||Geometric least squares mean (ng*hr/mL)|5287.1||||||95.0||||||||Geometric least squares means for treatment A||||
72529467|NCT01192139|144588577|SUPERIORITY_OR_OTHER||Geometric least squares mean (ng*hr/mL)|4866.2||||||95.0||||||||Geometric least squares mean for treatment B||||
72529468|NCT01192139|144588577|SUPERIORITY_OR_OTHER||Geometric least squares mean (ng*hr/mL)|4746.8||||||95.0||||||||Geometric least squares means for treatment C||||
72529469|NCT01192139|144588578|NON_INFERIORITY_OR_EQUIVALENCE|BE was concluded if the 90% CIs for the test-to-reference ratios of geometric means were entirely contained within 0.800 to 1.250 for both Cmax and AUC0-inf of metformin.|Ratio of Geometric Least Squares Means|0.933|||||TWO_SIDED|95.0|0.865|1.007|||||Ratio = Treatment B/Treatment A. Geometric least squares means values are presented in other statistical analysis entries.|If there was no difference between the bioavailabilities of metformin from the FDC tablet versus metformin from coadministration of a metformin XR tablet under fed conditions, then 24 subjects would have provided 99% power to conclude BE with respect to Cmax and AUC0-inf. If there was a 5% difference, then 24 subjects would have provided 96% and 97% power to conclude BE with respect to Cmax and AUC0-inf, respectively.||1.007|0.865|
72529470|NCT01192139|144588578|NON_INFERIORITY_OR_EQUIVALENCE|Lack of food effect was concluded if the 90% CIs for the test-to-reference ratios of geometric means were entirely contained within (80%, 125%) for both Cmax and AUC(inf) of saxagliptin and metformin.|Ratio of Geometric Least Squares Means|0.898|||||TWO_SIDED|90.0|0.832|0.969|||||Ration = Treatment B/Treatment C. Geometric least squares means values are presented in other statistical analysis entries.|||0.969|0.832|
72529471|NCT01192139|144588578|SUPERIORITY_OR_OTHER||Geometric least squares mean (ng*hr/mL)|608.41||||||95.0||||||||Geometric least squares mean for treatment A||||
72529472|NCT01192139|144588578|SUPERIORITY_OR_OTHER||Geometric least squares mean (ng*hr/mL)|567.85||||||95.0||||||||Geometric least squares mean for treatment B||||
72529473|NCT01192139|144588578|SUPERIORITY_OR_OTHER||Geometric least squares mean (ng*hr/mL)|632.39||||||95.0||||||||Geometric least squares mean for treatment C||||
72529474|NCT03812224|144588584|SUPERIORITY||LS Mean Difference|-1.62|||<|0.001||95.0|-2.52|-0.73|||Generalized Linear Mixed Model|||The primary endpoint was analyzed using a generalized linear mixed model which includes treatment, visit, treatment-by-visit interaction, stratification factors of migraine type and prior migraine preventive treatment status, and baseline value as covariates and assumes a first-order auto regression covariance structure.||-0.73|-2.52|<0.001
72529475|NCT03812224|144588585|SUPERIORITY||Odds Ratio (OR)|2.33||||0.005|TWO_SIDED|95.0|1.29|4.23|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test, stratified by stratification factors of migraine type and prior migraine preventive treatment status.||||4.23|1.29|0.005
72529476|NCT03812224|144588586|SUPERIORITY||LS Mean Difference|-1.47|||<|0.001||95.0|-2.24|-0.71|||Generalized Linear Mixed Model|||Analysis utilizes a generalized linear mixed model which includes treatment, visit, treatment-by-visit interaction, stratification factors of migraine type (episodic migraine or chronic migraine) and prior migraine preventive treatment status (ever used or never used), and baseline value as covariates and assumes a first-order auto regression covariance structure.||-0.71|-2.24|<0.001
72529477|NCT02643420|144588643|NON_INFERIORITY|The margin of non-inferiority to be used in the study is 0.62 day. The non-inferiority of SPI-2012 to Pegfilgrastim was declared if the upper bound of 95% confidence interval (CI) of the difference in mean DSN between the treatment arms was \<0.62 days.|Mean Difference (Final Values)|-0.148|||<|0.0001|TWO_SIDED|95.0|-0.266|-0.031|||t-statistics|The p-values are based on the calculated t-statistics from the bootstrapped sample mean and standard deviation.||||-0.031|-0.266|<0.0001
72529478|NCT02643420|144588644|SUPERIORITY||Mean Difference (Final Values)|-0.25||||0.685|TWO_SIDED|95.0|-1.43|0.94|||Negative binomial regression|||||0.94|-1.43|0.685
72529479|NCT02643420|144588645|SUPERIORITY||Median Difference (Final Values)|1.2||||0.155|TWO_SIDED|95.0|0.93|1.56|||Asymptotic normality assumption|P-value was obtained based upon asymptotic normality assumption on the log10 transformed data.||||1.56|0.93|0.155
72529480|NCT02643420|144588646|SUPERIORITY||Percent Difference|1.1||||0.435|TWO_SIDED|95.0|-8.6|10.8|||Fisher Exact|||||10.8|-8.6|0.435
72529481|NCT02643420|144588647|NON_INFERIORITY|The margin of non-inferiority to be used in the study is 0.62 day. The non-inferiority of SPI-2012 to Pegfilgrastim was declared if the upper bound of 95% CI of the difference in mean DSN between the treatment arms was \<0.62 days.|Mean Difference (Final Values)|0.042|||<|0.0001|TWO_SIDED|95.0|-0.032|0.116|||t-statistics|||DSN in Cycle 2||0.116|-0.032|<0.0001
72407689|NCT05446909|144323804|SUPERIORITY||||||>|0.05|||||||ANOVA|||||||>0.05
72407690|NCT05446909|144323805|SUPERIORITY||||||>|0.05|||||||ANOVA|||||||>0.05
72407691|NCT05446909|144323806|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<0.05
72407692|NCT05446909|144323807|SUPERIORITY|||||||0.754|||||||ANOVA|||||||0.754
72529482|NCT02643420|144588647|NON_INFERIORITY|The margin of non-inferiority to be used in the study is 0.62 day. The non-inferiority of SPI-2012 to Pegfilgrastim was declared if the upper bound of 95% CI of the difference in mean DSN between the treatment arms was \<0.62 days.|Mean Difference (Final Values)|0.026|||<|0.0001|TWO_SIDED|95.0|-0.032|0.085|||t-statistics|||DSN in Cycle 3||0.085|-0.032|<0.0001
72571827|NCT02912650|144671807|SUPERIORITY_OR_OTHER||LS Mean Difference|0.56|||<|0.001|TWO_SIDED|95.0|0.38|0.75|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.75|0.38|<0.001
72571828|NCT02912650|144671807|SUPERIORITY_OR_OTHER||LS Mean Difference|1.17|||<|0.001|TWO_SIDED|95.0|0.9|1.43|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.43|0.90|<0.001
72571829|NCT02912650|144671807|SUPERIORITY_OR_OTHER||LS Mean Difference|0.84|||<|0.001|TWO_SIDED|95.0|0.57|1.11|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.11|0.57|<0.001
72571830|NCT02912650|144671807|SUPERIORITY_OR_OTHER||LS Mean Difference|0.33|||<|0.001|TWO_SIDED|95.0|0.14|0.51|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.51|0.14|<0.001
72571831|NCT02912650|144671807|SUPERIORITY_OR_OTHER||LS Mean Difference|1.38|||<|0.001|TWO_SIDED|95.0|1.11|1.65|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.65|1.11|<0.001
72571832|NCT02912650|144671807|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3||||0.002|TWO_SIDED|95.0|0.11|0.48|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.48|0.11|0.002
72571833|NCT02912650|144671807|SUPERIORITY_OR_OTHER||LS Mean Difference|0.76|||<|0.001|TWO_SIDED|95.0|0.56|0.95|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.95|0.56|<0.001
72571834|NCT02912650|144671807|SUPERIORITY_OR_OTHER||LS Mean Difference|1.09|||<|0.001|TWO_SIDED|95.0|0.82|1.36|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.36|0.82|<0.001
72571835|NCT02912650|144671807|SUPERIORITY_OR_OTHER||LS Mean Difference|0.63|||<|0.001|TWO_SIDED|95.0|0.35|0.9|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.90|0.35|<0.001
72407693|NCT05446909|144323808|SUPERIORITY|||||||0.985|||||||ANOVA|||||||0.985
72529483|NCT02643420|144588647|NON_INFERIORITY|The margin of non-inferiority to be used in the study is 0.62 day. The non-inferiority of SPI-2012 to Pegfilgrastim was declared if the upper bound of 95% CI of the difference in mean DSN between the treatment arms was \<0.62 days.|Mean Difference (Final Values)|0.027|||<|0.0001|TWO_SIDED|95.0|-0.036|0.089|||t-statistics|||DSN in Cycle 4||0.089|-0.036|<0.0001
72529484|NCT02643420|144588648|SUPERIORITY||Percent Difference|0.3||||1|TWO_SIDED|95.0|-9.5|10.0|||Fisher Exact|||||10.0|-9.5|1.000
72529485|NCT02643420|144588649|SUPERIORITY||Percent Difference|0.0||||1|TWO_SIDED|95.0|-9.7|9.8|||Fisher Exact|||FN in Cycle 2||9.8|-9.7|1.000
72529486|NCT02643420|144588649|SUPERIORITY||Percent Difference|1.6||||0.201|TWO_SIDED|95.0|-8.2|11.3|||Fisher Exact|||FN in Cycle 3||11.3|-8.2|0.201
72529487|NCT02643420|144588649|SUPERIORITY||Percent Difference|1.0||||0.232|TWO_SIDED|95.0|-8.7|10.8|||Fisher Exact|||FN in Cycle 4||10.8|-8.7|0.232
72529488|NCT04138758|144588668|OTHER||Hazard Ratio (HR)|0.76|||||TWO_SIDED|95.0|0.68|0.85|||||Hazard Ratio lower than 1 favors Tiotropium + Olodaterol.|Cox proportional hazard regression models were used to assess the effect of Tiotropium + Olodaterol combination versus the Long-acting beta agonist / inhaled corticosteroid therapy combination on the risk of a first COPD exacerbation.||0.85|0.68|
72529489|NCT04138758|144588669|OTHER||Hazard Ratio (HR)|0.74|||||TWO_SIDED|95.0|0.57|0.97|||||Hazard Ratio lower than 1 favors Tiotropium + Olodaterol.|Cox proportional hazard regression models were used to assess the effect of Tiotropium + Olodaterol combination versus the Long-acting beta agonist / inhaled corticosteroid therapy combination on the risk of first hospitalization for community-acquired pneumonia.||0.97|0.57|
72529490|NCT04138758|144588670|OTHER|Cox proportional hazard regression models were used to assess the effect of Tiotropium + Olodaterol combination versus the Long-acting beta agonist / inhaled corticosteroid therapy combination on the risk of escalation.|Hazard Ratio (HR)|0.23|||||TWO_SIDED|95.0|0.19|0.27|||||Hazard Ratio lower than 1 favors Tiotropium + Olodaterol.|||0.27|0.19|
72529491|NCT04138758|144588671|OTHER||Hazard Ratio (HR)|0.22|||||TWO_SIDED|95.0|0.19|0.26|||||Hazard Ratio lower than 1 favors Tiotropium + Olodaterol.|Cox proportional hazard regression models were used to assess the effect of Tiotropium + Olodaterol combination versus the Long-acting beta agonist / inhaled corticosteroid therapy combination on the risk of escalation.||0.26|0.19|
72529492|NCT04138758|144588672|OTHER||Hazard Ratio (HR)|0.46|||||TWO_SIDED|95.0|0.42|0.51|||||Hazard Ratio lower than 1 favors Tiotropium + Olodaterol.|Cox proportional hazard regression models were used to assess the effect of Tiotropium + Olodaterol combination versus the Long-acting beta agonist / inhaled corticosteroid therapy combination on the risk of any element of a composite outcome including exacerbation, hospitalization for pneumonia, or escalation.||0.51|0.42|
72529493|NCT04138758|144588673|OTHER||Hazard Ratio (HR)|0.45|||||TWO_SIDED|95.0|0.41|0.49|||||Hazard Ratio lower than 1 favors Tiotropium + Olodaterol.|Cox proportional hazard regression models were used to assess the effect of Tiotropium + Olodaterol combination versus the Long-acting beta agonist / inhaled corticosteroid therapy combination on the risk of any element of a composite outcome including exacerbation, hospitalization for pneumonia, or escalation.||0.49|0.41|
72529494|NCT00089505|144588728|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|3.69|||<|0.001|TWO_SIDED|95.0|1.79|7.61||P-value was not adjusted for multiple interim analyses, but any adjustment would be negligible because Peto-Haybittle spending function was used as a basis for calculating the repeated confidence intervals used in interim monitoring.|Regression, Cox|The model was stratified by screening CD4 strata (\<50 vs. \>=50 cells/mm\^3).|The HR is for NVP/NVP vs. NVP/LPV\_r.|||7.61|1.79|<0.001
72571836|NCT02912650|144671807|SUPERIORITY_OR_OTHER||LS Mean Difference|0.46|||<|0.001|TWO_SIDED|95.0|0.27|0.65|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.65|0.27|<0.001
72407694|NCT05446909|144323809|SUPERIORITY|||||||0.877|||||||ANOVA|||||||0.877
72529495|NCT00089505|144588729|NON_INFERIORITY_OR_EQUIVALENCE|NoNVP/NVP regimen will be considered equivalent to the NoNVP/LPV\_r regimen if the two-sided 95% confidence interval for the hazard ratio for virologi falure is entirely below 2.0; equivalence will be established if the same confidence interval is entirely within the range 0.5 to 2.0.|Hazard Ratio (HR)|0.85||||0.43|TWO_SIDED|95.0|0.56|1.29||P-value is for a test of superiority and was not adjusted for interim analyses, but any adjustment would be negligible because Peto-Haybittle spending function was used as a basis for calculating the repeated confidence intervals used.|Regression, Cox|The cox proportional hazard model was stratified by screening CD4 strata (\<50 vs. \>=50 cells/mm3).|The HR is for NoNVP/NVP vs. NoNVP/LPV\_r.|||1.29|0.56|0.43
72529496|NCT01117428|144588733|EQUIVALENCE|Differences between Parts E and F in terms of Best Overall Response evaluated from screening until disease progression.||||||0.6645||||||No adjustment, 5% significance level|Fisher Exact|||||||0.6645
72542613|NCT01042977|144615151|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.0489|<|0.0001|TWO_SIDED|95.0|-0.5|-0.3||Significant at alpha=0.025 (2-sided). A hierarchical closed testing procedure was used to control Type I error across the primary \& key secondary objectives|ANCOVA|with treatment group and stratum as effects and baseline value as covariate for each endpoint|with stratum = age-by-insulin use-by-time from most recent qualifying CV event|H0: mean(treat) minus mean(placebo) = 0 versus the alternative HA: mean(treat) minus mean(placebo) =/= 0||-0.30|-0.50|<0.0001
72571837|NCT02912650|144671807|SUPERIORITY_OR_OTHER||LS Mean Difference|1.34|||<|0.001|TWO_SIDED|95.0|1.06|1.61|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.61|1.06|<0.001
72571838|NCT02912650|144671807|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3||||0.003|TWO_SIDED|95.0|0.1|0.49|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.49|0.10|0.003
72571839|NCT02912650|144671807|SUPERIORITY_OR_OTHER||LS Mean Difference|0.78|||<|0.001|TWO_SIDED|95.0|0.58|0.98|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.98|0.58|<0.001
72571840|NCT02912650|144671807|SUPERIORITY_OR_OTHER||LS Mean Difference|1.04|||<|0.001|TWO_SIDED|95.0|0.76|1.32|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.32|0.76|<0.001
72529497|NCT03018028|144588736|SUPERIORITY|This hypothesis was not controlled for multiplicity. Results are based on the data from the on-treatment without rescue medication observation period. The estimated treatment effect excludes the effect of any rescue medication and any effect after premature trial product discontinuation (hypothetical estimand).|Treatment difference|-1.1|||<|0.0001|TWO_SIDED|95.0|-1.4|-0.8||Unadjusted two-sided p-value for test of no difference from 0.|Mixed model for repeated measurements||Oral semaglutide 3 mg - Placebo|The analysis was based on a mixed model for repeated measurements (MMRM) that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 26. The independent effects were treatment and stratification factor as categorical fixed effects and the baseline HbA1c value as a covariate, all nested within visit, and an unstructured residual covariance matrix.||-0.8|-1.4|<0.0001
72529498|NCT03018028|144588736|SUPERIORITY|This hypothesis was not controlled for multiplicity. Results are based on the data from the on-treatment without rescue medication observation period. The estimated treatment effect excludes the effect of any rescue medication and any effect after premature trial product discontinuation (hypothetical estimand).|Treatment difference|-1.5|||<|0.0001|TWO_SIDED|95.0|-1.7|-1.2||Unadjusted two-sided p-value for test of no difference from 0.|Mixed model for repeated measurements||Oral semaglutide 7 mg - Placebo|The analysis was based on a MMRM that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 26. The independent effects were treatment and stratification factor as categorical fixed effects and the baseline HbA1c value as a covariate, all nested within visit, and an unstructured residual covariance matrix.||-1.2|-1.7|<0.0001
72529499|NCT03018028|144588736|SUPERIORITY|This hypothesis was not controlled for multiplicity. Results are based on the data from the on-treatment without rescue medication observation period. The estimated treatment effect excludes the effect of any rescue medication and any effect after premature trial product discontinuation (hypothetical estimand).|Treatment difference|-1.7|||<|0.0001|TWO_SIDED|95.0|-2.0|-1.4||Unadjusted two-sided p-value for test of no difference from 0.|Mixed model for repeated measurements||Oral semaglutide 14 mg - Placebo|The analysis was based on a MMRM that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 26. The independent effects were treatment and stratification factor as categorical fixed effects and the baseline HbA1c value as a covariate, all nested within visit, and an unstructured residual covariance matrix.||-1.4|-2.0|<0.0001
72529500|NCT03018028|144588736|SUPERIORITY|This hypothesis was not controlled for multiplicity. Results are based on the data from the on-treatment without rescue medication observation period. The estimated treatment effect excludes the effect of any rescue medication and any effect after premature trial product discontinuation (hypothetical estimand).|Treatment difference|0.3||||0.0799|TWO_SIDED|95.0|0.0|0.6||Unadjusted two-sided p-value for test of no difference from 0.|Mixed model for repeated measurements||Oral semaglutide 3 mg - Liraglutide 0.9 mg|The analysis was based on a MMRM that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 26. The independent effects were treatment and stratification factor as categorical fixed effects and the baseline HbA1c value as a covariate, all nested within visit, and an unstructured residual covariance matrix.||0.6|-0.0|0.0799
72529501|NCT03018028|144588736|SUPERIORITY|This hypothesis was not controlled for multiplicity. Results are based on the data from the on-treatment without rescue medication observation period. The estimated treatment effect excludes the effect of any rescue medication and any effect after premature trial product discontinuation (hypothetical estimand).|Treatment difference|-0.1||||0.3942|TWO_SIDED|95.0|-0.4|0.2||Unadjusted two-sided p-value for test of no difference from 0.|Mixed model for repeated measurements||Oral semaglutide 7 mg - Liraglutide 0.9 mg|The analysis was based on a MMRM that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 26. The independent effects were treatment and stratification factor as categorical fixed effects and the baseline HbA1c value as a covariate, all nested within visit, and an unstructured residual covariance matrix.||0.2|-0.4|0.3942
72529502|NCT03018028|144588736|SUPERIORITY|This hypothesis was not controlled for multiplicity. Results are based on the data from the on-treatment without rescue medication observation period. The estimated treatment effect excludes the effect of any rescue medication and any effect after premature trial product discontinuation (hypothetical estimand).|Treatment difference|-0.3||||0.0272|TWO_SIDED|95.0|-0.6|0.0||Unadjusted two-sided p-value for test of no difference from 0.|Mixed model for repeated measurement||Oral semaglutide 14 mg - Liraglutide 0.9 mg|The analysis was based on a MMRM that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 26. The independent effects were treatment and stratification factor as categorical fixed effects and the baseline HbA1c value as a covariate, all nested within visit, and an unstructured residual covariance matrix.||-0.0|-0.6|0.0272
72542614|NCT01042977|144615152|SUPERIORITY_OR_OTHER||Risk Difference (RD)|7.0|||<|0.0001|TWO_SIDED|95.0|4.3|9.8||Significant at alpha=0.025 (2-sided). A hierarchical closed testing procedure was used to control Type I error across the primary \& key secondary objectives|Cochran-Mantel-Haenszel|with age-by-insulin use-by-time from most recent qualifying CV event as stratum||H0: proportion(treat) minus proportion(placebo) = 0 versus the alternative HA: proportion(treat) minus proportion(placebo) =/= 0||9.8|4.3|<0.0001
72625586|NCT01968980|144780523|SUPERIORITY_OR_OTHER||LS Mean Difference|-11.8|STANDARD_ERROR_OF_MEAN|1.47|||TWO_SIDED|95.0|-14.7|-8.9||||||LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region.||-8.9|-14.7|
72407695|NCT04875520|144323824|NON_INFERIORITY|Overall rate compared using GEE model includes any person affiliated with the school who tested positive at least once during the study period that the schools reported to us that were positive. This includes people in our testing program and not in our testing program.|Mean Difference (Final Values)|-0.01845||||0.25|TWO_SIDED|95.0|-0.04981|0.01292|||generalized estimating equations|||||0.01292|-0.04981|0.25
72407696|NCT05773287|144323846|SUPERIORITY|||||||0.509||||||The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|||||||0.509
72407697|NCT05773287|144323847|SUPERIORITY|||||||0.552||||||The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|||||||0.552
72407698|NCT00261716|144323868|SUPERIORITY_OR_OTHER|||||||0.33|||||||Chi-squared|1 degree of freedom||Intent to treat analysis||||.33
72407699|NCT00261716|144323869|SUPERIORITY_OR_OTHER|||||||0.75|||||||t-test, 2 sided|degrees of freedom=36||intent to treat analysis||||.75
72529503|NCT03018028|144588736|SUPERIORITY|This hypothesis was not controlled for multiplicity. Results are based on the data from the in-trial observation period. The estimated treatment effect includes the effect of any rescue medication and any effect after premature trial product discontinuation (treatment policy estimand).|Treatment difference|-0.8|||<|0.0001|TWO_SIDED|95.0|-1.1|-0.5||Unadjusted two-sided p-value for test of no difference from 0.|Pattern Mixture model||Oral semaglutide 3 mg - Placebo|The analysis was based on a pattern mixture model using multiple imputation to handle missing week 26 data, assuming that data were missing at random within the groups used for imputation. The imputed data sets were analysed using an analysis of covariance (ANCOVA) model with treatment and stratification factor as categorical fixed effects and baseline HbA1c as a covariate for each of the 1000 imputed complete data sets, and pooled by Rubin's rule to draw inference.||-0.5|-1.1|<0.0001
72529504|NCT03018028|144588736|SUPERIORITY|This hypothesis was not controlled for multiplicity. Results are based on the data from the in-trial observation period. The estimated treatment effect includes the effect of any rescue medication and any effect after premature trial product discontinuation (treatment policy estimand).|Treatment difference|-1.2|||<|0.0001|TWO_SIDED|95.0|-1.5|-0.9||Unadjusted two-sided p-value for test of no difference from 0.|Pattern Mixture model||Oral semaglutide 7 mg - Placebo|The analysis was based on a pattern mixture model using multiple imputation to handle missing week 26 data, assuming that data were missing at random within the groups used for imputation. The imputed data sets were analysed using an ANCOVA model with treatment and stratification factor as categorical fixed effects and baseline HbA1c as a covariate for each of the 1000 imputed complete data sets, and pooled by Rubin's rule to draw inference.||-0.9|-1.5|<0.0001
72529505|NCT03018028|144588736|SUPERIORITY|This hypothesis was not controlled for multiplicity. Results are based on the data from the in-trial observation period. The estimated treatment effect includes the effect of any rescue medication and any effect after premature trial product discontinuation (treatment policy estimand).|Treatment difference|-1.4|||<|0.0001|TWO_SIDED|95.0|-1.7|-1.1||Unadjusted two-sided p-value for test of no difference from 0.|Pattern Mixture model||Oral semaglutide 14 mg - Placebo|The analysis was based on a pattern mixture model using multiple imputation to handle missing week 26 data, assuming that data were missing at random within the groups used for imputation. The imputed data sets were analysed using an ANCOVA model with treatment and stratification factor as categorical fixed effects and baseline HbA1c as a covariate for each of the 1000 imputed complete data sets, and pooled by Rubin's rule to draw inference.||-1.1|-1.7|<0.0001
72529506|NCT03018028|144588736|SUPERIORITY|This hypothesis was not controlled for multiplicity. Results are based on the data from the in-trial observation period. The estimated treatment effect includes the effect of any rescue medication and any effect after premature trial product discontinuation (treatment policy estimand).|Treatment difference|0.2||||0.1958|TWO_SIDED|95.0|-0.1|0.5||Unadjusted two-sided p-value for test of no difference from 0.|Pattern Mixture model||Oral semaglutide 3 mg - Liraglutide 0.9 mg|The analysis was based on a pattern mixture model using multiple imputation to handle missing week 26 data, assuming that data were missing at random within the groups used for imputation. The imputed data sets were analysed using an ANCOVA model with treatment and stratification factor as categorical fixed effects and baseline HbA1c as a covariate for each of the 1000 imputed complete data sets, and pooled by Rubin's rule to draw inference.||0.5|-0.1|0.1958
72542615|NCT01042977|144615153|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.93|STANDARD_ERROR_OF_MEAN|0.1957|<|0.0001|TWO_SIDED|95.0|-2.31|-1.54||Significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure|ANCOVA|with treatment group and stratum as effects and baseline value as covariate|with stratum = age-by-insulin use-by-time from most recent qualifying CV event|H0: mean(treat) minus mean(placebo) = 0 versus the alternative HA: mean(treat) minus mean(placebo) =/= 0||-1.54|-2.31|<0.0001
72625587|NCT01968980|144780524|SUPERIORITY_OR_OTHER||LS Mean Difference|3.5|STANDARD_ERROR_OF_MEAN|0.75|||TWO_SIDED|95.0|2.0|4.9||||||LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region.||4.9|2.0|
72625588|NCT01968980|144780525|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.0|STANDARD_ERROR_OF_MEAN|0.12|||TWO_SIDED|95.0|-2.2|-1.8||||||Week 12: LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region.||-1.8|-2.2|
72407700|NCT00261716|144323870|SUPERIORITY_OR_OTHER|||||||0.41|||||||t-test, 2 sided|degrees of freedom=17||||||.41
72407701|NCT00261716|144323871|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Fisher Exact|Fishers exact= 1.0; one degree of freedom||intent to treat --all participants who obtained at least one job||||>.05
72407702|NCT00261716|144323871|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Fisher Exact|||||||>.05
72407703|NCT00261716|144323872|SUPERIORITY_OR_OTHER|||||||0.37|||||||Mixed Models Analysis|employment status effect- F(1,12)=..85||Intent to treat analysis||||.37
72407704|NCT00261716|144323872|SUPERIORITY_OR_OTHER|||||||0.16|||||||Mixed Models Analysis|time effect F(1,54)=.2.05||||||.16
72407705|NCT00261716|144323872|SUPERIORITY_OR_OTHER|||||||0.63|||||||Mixed Models Analysis|employment status X time effect F (1,54)=.. 24||||||.63
72407706|NCT00261716|144323873|SUPERIORITY_OR_OTHER|||||||0.62|||||||Mixed Models Analysis|employment status effect F(1,12)=.26||intent to treat analysis||||.62
72407707|NCT00261716|144323873|SUPERIORITY_OR_OTHER|||||||0.65|||||||Mixed Models Analysis|time effect F (1,58)=.21 ,.||||||.65
72407708|NCT00261716|144323873|SUPERIORITY_OR_OTHER|||||||0.81|||||||Mixed Models Analysis|employment status X time effect F(1,58)=.06||||||.81
72529507|NCT03018028|144588736|SUPERIORITY|This hypothesis was not controlled for multiplicity. Results are based on the data from the in-trial observation period. The estimated treatment effect includes the effect of any rescue medication and any effect after premature trial product discontinuation (treatment policy estimand).|Treatment difference|-0.2||||0.1868|TWO_SIDED|95.0|-0.5|0.1||Unadjusted two-sided p-value for test of no difference from 0.|Pattern Mixture model||Oral semaglutide 7 mg - Liraglutide 0.9 mg|The analysis was based on a pattern mixture model using multiple imputation to handle missing week 26 data, assuming that data were missing at random within the groups used for imputation. The imputed data sets were analysed using an ANCOVA model with treatment and stratification factor as categorical fixed effects and baseline HbA1c as a covariate for each of the 1000 imputed complete data sets, and pooled by Rubin's rule to draw inference.||0.1|-0.5|0.1868
72529508|NCT03018028|144588736|SUPERIORITY|This hypothesis was not controlled for multiplicity. Results are based on the data from the in-trial observation period. The estimated treatment effect includes the effect of any rescue medication and any effect after premature trial product discontinuation (treatment policy estimand).|Treatment difference|-0.4||||0.0077|TWO_SIDED|95.0|-0.7|-0.1||Unadjusted two-sided p-value for test of no difference from 0.|Pattern Mixture model||Oral semaglutide 14 mg - Liraglutide 0.9 mg|The analysis was based on a pattern mixture model using multiple imputation to handle missing week 26 data, assuming that data were missing at random within the groups used for imputation. The imputed data sets were analysed using an ANCOVA model with treatment and stratification factor as categorical fixed effects and baseline HbA1c as a covariate for each of the 1000 imputed complete data sets, and pooled by Rubin's rule to draw inference.||-0.1|-0.7|0.0077
72529509|NCT03018028|144588763|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|0.63||||0.2579|TWO_SIDED|95.0|0.29|1.4||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox||Oral semaglutide 3 mg / Placebo|Time to initiation of additional anti-diabetic medication was analysed using a Cox proportional hazards model with treatment and stratification factor as categorical fixed effects and baseline HbA1c as covariate. Withdrawal for any reason or lost to follow-up contributed to the analysis as events (initiation of additional anti-diabetic medication). Censoring time was one day before planned end of treatment.||1.40|0.29|0.2579
72529510|NCT03018028|144588763|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|0.25||||0.0052|TWO_SIDED|95.0|0.1|0.66||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox||Oral semaglutide 7 mg / Placebo|Time to initiation of additional anti-diabetic medication was analysed using a Cox proportional hazards model with treatment and stratification factor as categorical fixed effects and baseline HbA1c as covariate. Withdrawal for any reason or lost to follow-up contributed to the analysis as events (initiation of additional anti-diabetic medication). Censoring time was one day before planned end of treatment.||0.66|0.10|0.0052
72529511|NCT03018028|144588763|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|0.31||||0.0259|TWO_SIDED|95.0|0.11|0.87||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox||Oral semaglutide 14 mg / Placebo|Time to initiation of additional anti-diabetic medication was analysed using a Cox proportional hazards model with treatment and stratification factor as categorical fixed effects and baseline HbA1c as covariate. Withdrawal for any reason or lost to follow-up contributed to the analysis as events (initiation of additional anti-diabetic medication). Censoring time was one day before planned end of treatment.||0.87|0.11|0.0259
72529512|NCT03018028|144588763|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|2.7||||0.0674|TWO_SIDED|95.0|0.93|7.8||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox||Oral semaglutide 3 mg / Liraglutide 0.9 mg|Time to initiation of additional anti-diabetic medication was analysed using a Cox proportional hazards model with treatment and stratification factor as categorical fixed effects and baseline HbA1c as covariate. Withdrawal for any reason or lost to follow-up contributed to the analysis as events (initiation of additional anti-diabetic medication). Censoring time was one day before planned end of treatment.||7.80|0.93|0.0674
72529513|NCT03018028|144588763|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|1.07||||0.9087|TWO_SIDED|95.0|0.32|3.54||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox||Oral semaglutide 7 mg / Liraglutide 0.9 mg|Time to initiation of additional anti-diabetic medication was analysed using a Cox proportional hazards model with treatment and stratification factor as categorical fixed effects and baseline HbA1c as covariate. Withdrawal for any reason or lost to follow-up contributed to the analysis as events (initiation of additional anti-diabetic medication). Censoring time was one day before planned end of treatment.||3.54|0.32|0.9087
72571841|NCT02912650|144671807|SUPERIORITY_OR_OTHER||LS Mean Difference|0.56|||<|0.001|TWO_SIDED|95.0|0.28|0.84|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.84|0.28|<0.001
72571842|NCT02912650|144671807|SUPERIORITY_OR_OTHER||LS Mean Difference|0.48|||<|0.001|TWO_SIDED|95.0|0.29|0.68|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.68|0.29|<0.001
72571843|NCT02912650|144671807|SUPERIORITY_OR_OTHER||LS Mean Difference|1.28|||<|0.001|TWO_SIDED|95.0|1.0|1.57|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.57|1.00|<0.001
72369384|NCT03843541|144248708|NON_INFERIORITY|Non-inferiority was declared if the one-sided confidence interval was within the interval.|Probability scale treatment difference|0.5|||<|0.001|TWO_SIDED|98.75|0.45|1.0|||Modified Mann-Whitney U Statistic||"The point estimates of treatment differences in probability scale together with associated one-side confidence interval (97.5% or 98.75%) were computed according to Hochberg if both superiority contrasts were found statistically significant.~."|||1.00|0.45|<0.001
72369385|NCT03843541|144248709|SUPERIORITY|||||||0.356|||||||Modified Mann-Whitney U Statistic|||||||0.356
72369386|NCT03843541|144248709|SUPERIORITY|||||||0.007|||||||Modified Mann-Whitney U Statistic|||||||0.007
72369387|NCT03843541|144248710|SUPERIORITY|||||||0.38|||||||Modified Mann-Whitney U Statistic|||||||0.380
72369388|NCT03843541|144248710|SUPERIORITY|||||||0.018|||||||Modified Mann-Whitney U Statistic|||||||0.018
72369389|NCT03843541|144248711|SUPERIORITY|||||||0.366|||||||Modified Mann-Whitney U Statistic|||||||0.366
72369390|NCT03843541|144248711|SUPERIORITY|||||||0.027|||||||Modified Mann-Whitney U Statistic|||||||0.027
72369391|NCT03843541|144248712|SUPERIORITY|||||||0.052|||||||Modified Mann-Whitney U Statistic|||||||0.052
72369392|NCT03843541|144248712|SUPERIORITY|||||||0.058|||||||Modified Mann-Whitney U Statistic|||||||0.058
72529514|NCT03018028|144588763|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|1.33||||0.6498|TWO_SIDED|95.0|0.38|4.62||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox||Oral semaglutide 14 mg / Liraglutide 0.9 mg|Time to initiation of additional anti-diabetic medication was analysed using a Cox proportional hazards model with treatment and stratification factor as categorical fixed effects and baseline HbA1c as covariate. Withdrawal for any reason or lost to follow-up contributed to the analysis as events (initiation of additional anti-diabetic medication). Censoring time was one day before planned end of treatment.||4.62|0.38|0.6498
72529515|NCT03018028|144588764|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|0.34||||0.0219|TWO_SIDED|95.0|0.14|0.86||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox||Oral semaglutide 3 mg / Placebo|Time to initiation of rescue medication was analysed using a Cox proportional hazards model with treatment and stratification factor as categorical fixed effects and baseline HbA1c as covariate. Censoring time was one day before last day on trial product.||0.86|0.14|0.0219
72529516|NCT03018028|144588764|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|0.15||||0.0005|TWO_SIDED|95.0|0.05|0.44||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox||Oral semaglutide 7 mg / Placebo|Time to initiation of rescue medication was analysed using a Cox proportional hazards model with treatment and stratification factor as categorical fixed effects and baseline HbA1c as covariate. Censoring time was one day before last day on trial product.||0.44|0.05|0.0005
72529517|NCT03018028|144588764|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|0.23||||0.0098|TWO_SIDED|95.0|0.07|0.7||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox||Oral semaglutide 14 mg / Placebo|Time to initiation of rescue medication was analysed using a Cox proportional hazards model with treatment and stratification factor as categorical fixed effects and baseline HbA1c as covariate. Censoring time was one day before last day on trial product.||0.70|0.07|0.0098
72529518|NCT03018028|144588764|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|2.95||||0.1193|TWO_SIDED|95.0|0.76|11.46||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox||Oral Semaglutide 3 mg / Liraglutide 0.9 mg|Time to initiation of rescue medication was analysed using a Cox proportional hazards model with treatment and stratification factor as categorical fixed effects and baseline HbA1c as covariate. Censoring time was one day before last day on trial product.||11.46|0.76|0.1193
72529519|NCT03018028|144588764|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|1.31||||0.7147|TWO_SIDED|95.0|0.31|5.56||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox||Oral Semaglutide 7 mg / Liraglutide 0.9 mg|Time to initiation of rescue medication was analysed using a Cox proportional hazards model with treatment and stratification factor as categorical fixed effects and baseline HbA1c as covariate. Censoring time was one day before last day on trial product.||5.56|0.31|0.7147
72529520|NCT03018028|144588764|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|1.97||||0.3765|TWO_SIDED|95.0|0.44|8.85||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox||Oral Semaglutide 14 mg / Liraglutide 0.9 mg|Time to initiation of rescue medication was analysed using a Cox proportional hazards model with treatment and stratification factor as categorical fixed effects and baseline HbA1c as covariate. Censoring time was one day before last day on trial product.||8.85|0.44|0.3765
72529521|NCT02532998|144588786|SUPERIORITY_OR_OTHER||Treatment differences|-1.258|||||TWO_SIDED|90.0|-1.721|0.7945|||mixed linear model|Analyses done using mixed linear model involving fixed effect, random effect, and a covariate.||Statistical analysis of urinary sodium/potassium ratio between Treatment C and Treatment D.||0.7945|-1.721|
72529522|NCT02532998|144588801|SUPERIORITY_OR_OTHER||Treatment differences|3.409|||||TWO_SIDED|90.0|2.946|3.872|||mixed linear model|Analyses done using mixed linear model involving fixed effect, random effect, and a covariate.||Statistical analysis of urinary sodium/potassium ratio between Treatment A and Treatment B.||3.872|2.946|
72529523|NCT02519777|144588813|SUPERIORITY|||||||0.6|||||||t-test, 2 sided|||Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm B: DTG and placebo MVC in change in normalized composite neurocognitive test scores at Week 48 from baseline||||0.60
72529524|NCT02519777|144588813|SUPERIORITY|||||||0.33|||||||t-test, 2 sided|||Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm C: MVC and DTG in change in normalized composite neurocognitive test scores at Week 48 from baseline||||0.33
72529525|NCT02519777|144588813|SUPERIORITY|||||||0.61|||||||t-test, 2 sided|||Under the null hypothesis, it was assumed there was no difference between Arm B: DTG and placebo MVC and Arm C: MVC and DTG in change in normalized composite neurocognitive test scores at Week 48 from baseline||||0.61
72625589|NCT01968980|144780525|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.8|STANDARD_ERROR_OF_MEAN|0.13|||TWO_SIDED|95.0|-2.1|-1.6||||||Week 24: LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region.||-1.6|-2.1|
72529526|NCT02519777|144588815|SUPERIORITY|||||||0.61|||||||t-test, 2 sided|||Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm B: DTG and placebo MVC in change in normalized composite neurocognitive test scores at Week 24 from baseline||||0.61
72369393|NCT03843541|144248713|SUPERIORITY|||||||0.309|||||||Modified Mann-Whitney U Statistic|||||||0.309
72369394|NCT03843541|144248713|SUPERIORITY|||||||0.006|||||||Modified Mann-Whitney U Statistic|||||||0.006
72369395|NCT05307692|144248720|SUPERIORITY||Difference of Least Square (LS) Means|-1.5|STANDARD_ERROR_OF_MEAN|1.47||0.308|TWO_SIDED|80.0|-3.41|0.39|||Mixed model repeated measures|||||0.39|-3.41|0.308
72529527|NCT02519777|144588815|SUPERIORITY|||||||0.72|||||||t-test, 2 sided|||Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm B: DTG and placebo MVC in change in normalized composite neurocognitive test scores at Week 72 from baseline||||0.72
72625590|NCT01968980|144780525|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.6|STANDARD_ERROR_OF_MEAN|0.12|||TWO_SIDED|95.0|-1.8|-1.3||||||Week 52: LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region.||-1.3|-1.8|
72407709|NCT00261716|144323874|SUPERIORITY_OR_OTHER|||||||0.19|||||||Mixed Models Analysis|employment status effect F(1,12)=1.95,||Intent to treat analysis||||.19
72407710|NCT00261716|144323874|SUPERIORITY_OR_OTHER|||||||0.09|||||||Mixed Models Analysis|time effect (1.54)=2.99,||||||.09
72407711|NCT00261716|144323874|SUPERIORITY_OR_OTHER|||||||0.39|||||||Mixed Models Analysis|employment status X time effect (F(1,54)=.74||||||.39
72407712|NCT03969212|144323899|SUPERIORITY||Adjusted OR (BMX vs Placebo)|0.68|||=|0.013|TWO_SIDED|95.38|0.5|0.93|||GEE|||The odds ratio (OR) shown represents the odds of Baloxavir Marboxil (BMX) versus the odds of Placebo.||0.93|0.50|= 0.013
72407713|NCT03969212|144323900|SUPERIORITY||Adjusted OR (BMX vs Placebo)|0.75|||=|0.155|TWO_SIDED|95.38|0.5|1.12|||GEE model|||The OR shown represents the odds of BMX versus the odds of Placebo.||1.12|0.50|= 0.1550
72407714|NCT03969212|144323901|OTHER||Odds Ratio (BMX vs Placebo}]|0.76|||||TWO_SIDED|95.38|0.55|1.06||||||The OR shown represents the odds of BMX versus the odds of Placebo.||1.06|0.55|
72407715|NCT03969212|144323902|OTHER||Odds Ratio (BMX vs Placebo)|0.69|||||TWO_SIDED|95.38|0.46|1.04||||||The OR shown represents the odds of BMX versus the odds of Placebo.||1.04|0.46|
72529528|NCT02519777|144588815|SUPERIORITY|||||||0.79|||||||t-test, 2 sided|||Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm B: DTG and placebo MVC in change in normalized composite neurocognitive test scores at Week 96 from baseline||||0.79
72529529|NCT02519777|144588815|SUPERIORITY|||||||0.55|||||||t-test, 2 sided|||Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm C: MVC and DTG in change in normalized composite neurocognitive test scores at Week 24 from baseline||||0.55
72407716|NCT03969212|144323903|OTHER||Adjusted OR (BMX vs Placebo)|0.66|||||TWO_SIDED|95.38|0.48|0.91|||GEE model|||The OR shown represents the odds of BMX versus the odds of Placebo.||0.91|0.48|
72529530|NCT02519777|144588815|SUPERIORITY|||||||0.47|||||||t-test, 2 sided|||Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm C: MVC and DTG in change in normalized composite neurocognitive test scores at Week 72 from baseline||||0.47
72529531|NCT02519777|144588815|SUPERIORITY|||||||0.95|||||||t-test, 2 sided|||Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm C: MVC and DTG in change in normalized composite neurocognitive test scores at Week 96 from baseline||||0.95
72529532|NCT02519777|144588815|SUPERIORITY|||||||0.85|||||||t-test, 2 sided|||Under the null hypothesis, it was assumed there was no difference between Arm B: DTG and placebo MVC and Arm C: MVC and DTG in change in normalized composite neurocognitive test scores at Week 24 from baseline||||0.85
72625591|NCT01968980|144780526|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.02|||TWO_SIDED|95.0|-0.5|-0.4||||||Week 12: LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region.||-0.4|-0.5|
72407717|NCT03969212|144323904|OTHER||Adjusted OR (BMX vs Placebo)|0.73|||||TWO_SIDED|95.38|0.48|1.09|||Two-Sided P-value|||The OR shown represents the odds of BMX versus the odds of Placebo.||1.09|0.48|
72407718|NCT03969212|144323905|OTHER||Adjusted OR (BMX vs Placebo)|0.71|||||TWO_SIDED|95.38|0.53|0.94|||Two-Sided P-value|||The OR shown represents the odds of BMX versus the odds of Placebo.||0.94|0.53|
72407719|NCT03969212|144323906|OTHER||Odds Ratio (BMX vs Placebo)|0.79|||||TWO_SIDED|95.38|0.59|1.06||||||The OR shown represents the odds of BMX versus the odds of Placebo.||1.06|0.59|
72407720|NCT03969212|144323907|OTHER||Adjusted OR (BMX vs Placebo)|0.72|||||TWO_SIDED|95.38|0.49|1.07|||Two-Sided P-value|||The OR shown represents the odds of BMX versus the odds of Placebo.||1.07|0.49|
72407721|NCT03969212|144323908|OTHER||Odds Ratio (BMX vs Placebo)|0.71|||||TWO_SIDED|95.38|0.48|1.04||||||The OR shown represents the odds of BMX versus the odds of Placebo.||1.04|0.48|
72407722|NCT03773757|144323924|SUPERIORITY|Longitudinal measures of NPI-Q patient over 24 months were compared between the two groups using mixed effects model that included a group indicator variable, time since baseline, and an interaction between group and time as independent variables. Unstructured variance-covariance matrix was used to adjust for within-subject correlations over time. Predicted differences in mean scores between the two groups at each time point were estimated using the contrast procedures in the mixed model.||||||0.8719|||||||Mixed Models Analysis|||||||0.8719
72407723|NCT03773757|144323925|SUPERIORITY|Longitudinal measures of SM-EOLD over 24 months were compared between the two groups using mixed effects model that included a group indicator variable, time since baseline, and an interaction between group and time as independent variables. Unstructured variance-covariance matrix was used to adjust for within-subject correlations over time. Predicted differences in mean scores between the two groups at each time point were estimated using the contrast procedures in the mixed model.||||||0.8389|||||||Mixed Models Analysis|||||||0.8389
72529533|NCT02519777|144588815|SUPERIORITY|||||||0.67|||||||t-test, 2 sided|||Under the null hypothesis, it was assumed there was no difference between Arm B: DTG and placebo MVC and Arm C: MVC and DTG in change in normalized composite neurocognitive test scores at Week 72 from baseline||||0.67
72529534|NCT02519777|144588815|SUPERIORITY|||||||0.7|||||||t-test, 2 sided|||Under the null hypothesis, it was assumed there was no difference between Arm B: DTG and placebo MVC and Arm C: MVC and DTG in change in normalized composite neurocognitive test scores at Week 96 from baseline||||0.70
72529535|NCT02519777|144588816|SUPERIORITY|||||||0.99|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm B: DTG and placebo MVC in change in functional status scores at Week 24 from baseline||||0.99
72529536|NCT02519777|144588816|SUPERIORITY|||||||0.97|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm B: DTG and placebo MVC in change in functional status scores at Week 48 from baseline||||0.97
72529537|NCT02519777|144588816|SUPERIORITY|||||||0.79|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm B: DTG and placebo MVC in change in functional status scores at Week 72 from baseline||||0.79
72625592|NCT01968980|144780526|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.02|||TWO_SIDED|95.0|-0.4|-0.4||||||Week 24:LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region.||-0.4|-0.4|
72407724|NCT03773757|144323926|SUPERIORITY|Longitudinal measures of PHQ-8 over 24 months were compared between the two groups using mixed effects model that included a group indicator variable, time since baseline, and an interaction between group and time as independent variables. Unstructured variance-covariance matrix was used to adjust for within-subject correlations over time. Predicted differences in mean scores between the two groups at each time point were estimated using the contrast procedures in the mixed model.||||||0.3431|||||||Mixed Models Analysis|||||||0.3431
72529538|NCT02519777|144588816|SUPERIORITY|||||||0.99|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm B: DTG and placebo MVC in change in functional status scores at Week 96 from baseline||||0.99
72529539|NCT02519777|144588816|SUPERIORITY|||||||0.74|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm C: MVC and DTG in change in functional status scores at Week 24 from baseline||||0.74
72529540|NCT02519777|144588816|SUPERIORITY|||||||0.69|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm C: MVC and DTG in change in functional status scores at Week 48 from baseline||||0.69
72529541|NCT02519777|144588816|SUPERIORITY|||||||0.44|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm C: MVC and DTG in change in functional status scores at Week 72 from baseline||||0.44
72529542|NCT02519777|144588816|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm C: MVC and DTG in change in functional status scores at Week 96 from baseline||||1.00
72529543|NCT02519777|144588816|SUPERIORITY|||||||0.83|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm B: DTG and placebo MVC and Arm C: MVC and DTG in change in functional status scores at Week 24 from baseline||||0.83
72529544|NCT02519777|144588816|SUPERIORITY|||||||0.8|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm B: DTG and placebo MVC and Arm C: MVC and DTG in change in functional status scores at Week 48 from baseline||||0.80
72529545|NCT02519777|144588816|SUPERIORITY|||||||0.86|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm B: DTG and placebo MVC and Arm C: MVC and DTG in change in functional status scores at Week 72 from baseline||||0.86
72529546|NCT02519777|144588816|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm B: DTG and placebo MVC and Arm C: MVC and DTG in change in functional status scores at Week 96 from baseline||||1.00
72529547|NCT02519777|144588817|SUPERIORITY||Difference in Percentage of Participants|3.32|||||TWO_SIDED|95.0|-2.78|9.42||||||Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm B: DTG and placebo MVC in number of participants with HIV-1 RNA ≥ 50 copies/mL at Week 24||9.42|-2.78|
72529548|NCT02519777|144588817|SUPERIORITY||Difference in Percentage of Participants|5.17|||||TWO_SIDED|95.0|-0.53|10.87||||||Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm B: DTG and placebo MVC in number of participants with HIV-1 RNA ≥ 50 copies/mL at Week 48||10.87|-0.53|
72529549|NCT02519777|144588817|SUPERIORITY||Difference in Percentage of Participants|-8.21|||||TWO_SIDED|95.0|-16.56|0.13||||||Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm B: DTG and placebo MVC in number of participants with HIV-1 RNA ≥ 50 copies/mL at Week 96||0.13|-16.56|
72529550|NCT02519777|144588817|SUPERIORITY||Difference in Percentage of Participants|3.17|||||TWO_SIDED|95.0|-3.07|9.42||||||Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm C: MVC and DTG in number of participants with HIV-1 RNA ≥ 50 copies/mL at Week 24||9.42|-3.07|
72529551|NCT02519777|144588817|SUPERIORITY||Difference in Percentage of Participants|3.48|||||TWO_SIDED|95.0|-3.11|10.06||||||Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm C: MVC and DTG in number of participants with HIV-1 RNA ≥ 50 copies/mL at Week 48||10.06|-3.11|
72369396|NCT05307692|144248721|SUPERIORITY||Difference of Least Square (LS) Means|-1.5|STANDARD_ERROR_OF_MEAN|1.42||0.282|TWO_SIDED|80.0|-3.33|0.29|||Mixed model repeated measures|||||0.29|-3.33|0.282
72369397|NCT02003924|144248726|SUPERIORITY||Hazard Ratio (HR)|0.292|||<|0.0001|TWO_SIDED|95.0|0.241|0.352||P-value was based on stratified log-rank test by prostate-specific antigen (PSA) doubling time (\< 6 months, \>= 6 months) and prior or concurrent use of a bone targeting agent (yes, no). Threshold for significance at 0.05 level.|Log Rank||HR was based on a Cox regression model (with treatment as the only covariate) stratified by factors defined above, and was relative to placebo with \< 1 favoring Enzalutamide.|||0.352|0.241|<0.0001
72529552|NCT02519777|144588817|SUPERIORITY||Difference in Percentage of Participants|-1.85|||||TWO_SIDED|95.0|-7.89|4.19||||||Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm C: MVC and DTG in number of participants with HIV-1 RNA ≥ 50 copies/mL at Week 96||4.19|-7.89|
72529553|NCT02519777|144588817|SUPERIORITY||Difference in Percentage of Participants|-0.15|||||TWO_SIDED|95.0|-4.53|4.23||||||Under the null hypothesis, it was assumed there was no difference between Arm B: DTG and placebo MVC and Arm C: MVC and DTG in number of participants with HIV-1 RNA ≥ 50 copies/mL at Week 24||4.23|-4.53|
72529554|NCT02519777|144588817|SUPERIORITY||Difference in Percentage of Participants|-1.69|||||TWO_SIDED|95.0|-4.99|1.6||||||Under the null hypothesis, it was assumed there was no difference between Arm B: DTG and placebo MVC and Arm C: MVC and DTG in number of participants with HIV-1 RNA ≥ 50 copies/mL at Week 48||1.60|-4.99|
72571844|NCT02912650|144671807|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3||||0.003|TWO_SIDED|95.0|0.1|0.5|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.50|0.10|0.003
72529555|NCT02519777|144588817|SUPERIORITY||Difference in Percentage of Participants|6.36|||||TWO_SIDED|95.0|-2.7|15.42||||||Under the null hypothesis, it was assumed there was no difference between Arm B: DTG and placebo MVC and Arm C: MVC and DTG in number of participants with HIV-1 RNA ≥ 50 copies/mL at Week 96||15.42|-2.70|
72529556|NCT02519777|144588819|SUPERIORITY|||||||0.67|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm B: DTG and placebo MVC in change in CD4+ T-cell count at Week 24 from baseline||||0.67
72529557|NCT02519777|144588819|SUPERIORITY|||||||0.78|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm B: DTG and placebo MVC in change in CD4+ T-cell count at Week 48 from baseline||||0.78
72529558|NCT02519777|144588819|SUPERIORITY|||||||0.94|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm B: DTG and placebo MVC in change in CD4+ T-cell count at Week 96 from baseline||||0.94
72529559|NCT02519777|144588819|SUPERIORITY|||||||0.42|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm C: MVC and DTG in change in CD4+ T-cell count at Week 24 from baseline||||0.42
72529560|NCT02519777|144588819|SUPERIORITY|||||||0.07|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm C: MVC and DTG in change in CD4+ T-cell count at Week 48 from baseline||||0.07
72529561|NCT02519777|144588819|SUPERIORITY|||||||0.37|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm C: MVC and DTG in change in CD4+ T-cell count at Week 96 from baseline||||0.37
72407725|NCT03773757|144323927|SUPERIORITY|Longitudinal measures of NPI-Q caregiver distress over 24 months were compared between the two groups using mixed effects model including a group indicator variable, time since baseline, and an interaction between group and time as independent variables. Unstructured variance-covariance matrix was used to adjust for within-subject correlations over time. Predicted differences in mean scores between the two groups at each time point were estimated using the contrast procedures in the mixed model.||||||0.6612|||||||Mixed Models Analysis|||||||0.6612
72529562|NCT02519777|144588819|SUPERIORITY|||||||0.08|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm B: DTG and placebo MVC and Arm C: MVC and DTG in change in CD4+ T-cell count at Week 24 from baseline||||0.08
72529563|NCT02519777|144588819|SUPERIORITY|||||||0.33|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm B: DTG and placebo MVC and Arm C: MVC and DTG in change in CD4+ T-cell count at Week 48 from baseline||||0.33
72529564|NCT02519777|144588819|SUPERIORITY|||||||0.56|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm B: DTG and placebo MVC and Arm C: MVC and DTG in change in CD4+ T-cell count at Week 96 from baseline||||0.56
72625593|NCT01968980|144780526|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.02|||TWO_SIDED|95.0|-0.4|-0.3||||||Week 52: LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region.||-0.3|-0.4|
72529565|NCT02519777|144588821|SUPERIORITY|||||||0.63|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm B: DTG and placebo MVC in change in CD8+ T-cell count at Week 24 from baseline||||0.63
72529566|NCT02519777|144588821|SUPERIORITY|||||||0.38|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm B: DTG and placebo MVC in change in CD8+ T-cell count at Week 48 from baseline||||0.38
72529567|NCT02519777|144588821|SUPERIORITY|||||||0.95|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm B: DTG and placebo MVC in change in CD8+ T-cell count at Week 96 from baseline||||0.95
72529568|NCT02519777|144588821|SUPERIORITY|||||||0.27|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm C: MVC and DTG in change in CD8+ T-cell count at Week 24 from baseline||||0.27
72407726|NCT03773757|144323928|SUPERIORITY|A zero-inflated Poisson (ZIP) model was used to compare the mean numbers of hospitalization/ED events between the two groups. The ZIP model consists of a combination of a standard Poisson distribution for count data and a binary logistic regression model to account for additional zero events exceeding what would be expected from an underlying Poisson distribution.||||||0.0007|||||||Zero-Inflated Poisson Regression Model|||||||0.0007
72529569|NCT02519777|144588821|SUPERIORITY|||||||0.23|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm C: MVC and DTG in change in CD8+ T-cell count at Week 48 from baseline||||0.23
72529570|NCT02519777|144588821|SUPERIORITY|||||||0.09|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm C: MVC and DTG in change in CD8+ T-cell count at Week 96 from baseline||||0.09
72529571|NCT02519777|144588821|SUPERIORITY|||||||0.03|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm B: DTG and placebo MVC and Arm C: MVC and DTG in change in CD8+ T-cell count at Week 24 from baseline||||0.03
72529572|NCT02519777|144588821|SUPERIORITY|||||||0.02|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm B: DTG and placebo MVC and Arm C: MVC and DTG in change in CD8+ T-cell count at Week 48 from baseline||||0.02
72529573|NCT02519777|144588821|SUPERIORITY|||||||0.09|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm B: DTG and placebo MVC and Arm C: MVC and DTG in change in CD8+ T-cell count at Week 96 from baseline||||0.09
72529574|NCT02519777|144588822|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm B: DTG and placebo MVC in change in Log10 sCD14 in plasma at Week 48 from baseline||||1.00
72625594|NCT01968980|144780527|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|51.8|||||TWO_SIDED|95.0|25.24|106.1||||||Week 12: Odds ratio, associated 95% confidence interval and p-value from a Logistic Regression Model with fixed effects for treatment group,baseline value and geographical region was used for analysis.||106.10|25.24|
72407727|NCT01147653|144323929|SUPERIORITY||Mean Difference (Final Values)|0.6||||0.72|TWO_SIDED|95.0|-2.6|3.7|||t-test, 2 sided|||H0: The true mean 1-year change in GMFM-66 is the same on Autologous Umbilical Cord Blood and Placebo||3.7|-2.6|0.72
72407728|NCT01147653|144323930|SUPERIORITY|||||||0.39|||||||Wilcoxon (Mann-Whitney)|||||||0.39
72407729|NCT01147653|144323931|SUPERIORITY|||||||0.473|||||||Wilcoxon (Mann-Whitney)|||H0: The 12-month Behavior change score is identically distributed in patients assigned Autologous UCB Reinfusion First and Placebo First.||||0.473
72407730|NCT01147653|144323931|SUPERIORITY|||||||0.377|||||||Wilcoxon (Mann-Whitney)|||H0: The 12-month Bodily Pain/Discomfort change score is identically distributed in patients assigned Autologous UCB Reinfusion First and Placebo First.||||0.377
72407731|NCT01147653|144323931|SUPERIORITY|||||||0.844|||||||Wilcoxon (Mann-Whitney)|||H0: The 12-month Family Cohesion change score is identically distributed in patients assigned Autologous UCB Reinfusion First and Placebo First.||||0.844
72407732|NCT01147653|144323931|SUPERIORITY|||||||0.322|||||||Wilcoxon (Mann-Whitney)|||H0: The 12-month General Behavior change score is identically distributed in patients assigned Autologous UCB Reinfusion First and Placebo First.||||0.322
72407733|NCT01147653|144323931|SUPERIORITY|||||||0.927|||||||Wilcoxon (Mann-Whitney)|||H0: The 12-month General Health Perceptions change score is identically distributed in patients assigned Autologous UCB Reinfusion First and Placebo First.||||0.927
72407734|NCT01147653|144323931|SUPERIORITY|||||||0.199|||||||Wilcoxon (Mann-Whitney)|||H0: The 12-month Global Behavior change score is identically distributed in patients assigned Autologous UCB Reinfusion First and Placebo First.||||0.199
72529575|NCT02519777|144588822|SUPERIORITY|||||||0.95|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm C: MVC and DTG in change in Log10 sCD14 in plasma at Week 48 from baseline||||0.95
72529576|NCT02519777|144588822|SUPERIORITY|||||||0.96|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm B: DTG and placebo MVC and Arm C: MVC and DTG in change in Log10 sCD14 in plasma at Week 48 from baseline||||0.96
72529577|NCT02519777|144588823|SUPERIORITY|||||||0.52|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm B: DTG and placebo MVC in change in Log10 MIP-1 Beta in plasma at Week 48 from baseline||||0.52
72529578|NCT02519777|144588823|SUPERIORITY||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm C: MVC and DTG in change in Log10 MIP-1 Beta in plasma at Week 48 from baseline||||<0.01
72407735|NCT01147653|144323931|SUPERIORITY|||||||0.294|||||||Wilcoxon (Mann-Whitney)|||H0: The 12-month Growth and Development change score is identically distributed in patients assigned Autologous UCB Reinfusion First and Placebo First.||||0.294
72529579|NCT02519777|144588823|SUPERIORITY||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm B: DTG and placebo MVC and Arm C: MVC and DTG in change in Log10 MIP-1 Beta in plasma at Week 48 from baseline||||<0.01
72407736|NCT01147653|144323931|SUPERIORITY|||||||0.726|||||||Wilcoxon (Mann-Whitney)|||H0: The 12-month Overall Health change score is identically distributed in patients assigned Autologous UCB Reinfusion First and Placebo First.||||0.726
72407737|NCT01147653|144323931|SUPERIORITY|||||||0.315|||||||Wilcoxon (Mann-Whitney)|||H0: The 12-month Parental Impact-Emotional change score is identically distributed in patients assigned Autologous UCB Reinfusion First and Placebo First.||||0.315
72407738|NCT01147653|144323931|SUPERIORITY|||||||0.396|||||||Wilcoxon (Mann-Whitney)|||H0: The 12-month Parental Impact-Time change score is identically distributed in patients assigned Autologous UCB Reinfusion First and Placebo First.||||0.396
72407739|NCT01147653|144323931|SUPERIORITY|||||||0.381|||||||Wilcoxon (Mann-Whitney)|||H0: The 12-month Physical Abilities change score is identically distributed in patients assigned Autologous UCB Reinfusion First and Placebo First.||||0.381
72407740|NCT01147653|144323931|SUPERIORITY|||||||0.869|||||||Wilcoxon (Mann-Whitney)|||H0: The 12-month Temperament and Moods change score is identically distributed in patients assigned Autologous UCB Reinfusion First and Placebo First.||||0.869
72407741|NCT01147653|144323932|SUPERIORITY|||||||0.055|||||||Wilcoxon (Mann-Whitney)|||H0: The 12 month Access to Services change score is identically distributed in patients assigned Autologous Cord Blood Reinfusion First and Placebo First.||||0.055
72407742|NCT01147653|144323932|SUPERIORITY|||||||0.121|||||||Wilcoxon (Mann-Whitney)|||H0: The 12-month 2 Emotional Well Being and Self Esteem change score is identically distributed in patients assigned Autologous UCB Reinfusion First and Placebo First.||||0.121
72407743|NCT01147653|144323932|SUPERIORITY|||||||0.647|||||||Wilcoxon (Mann-Whitney)|||H0: The 12-month 2 Family Health change score is identically distributed in patients assigned Autologous UCB Reinfusion First and Placebo First.||||0.647
72407744|NCT01147653|144323932|SUPERIORITY|||||||0.17|||||||Wilcoxon (Mann-Whitney)|||H0: The 12-month Functioning change score is identically distributed in patients assigned Autologous UCB Reinfusion First and Placebo First.||||0.170
72407745|NCT01147653|144323932|SUPERIORITY|||||||0.41|||||||Wilcoxon (Mann-Whitney)|||H0: The 12-month Pain and Impact of Disability change score is identically distributed in patients assigned Autologous UCB Reinfusion First and Placebo First.||||0.410
72529580|NCT02519777|144588824|SUPERIORITY|||||||0.91|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm B: DTG and placebo MVC in change in Log10 sTNFr-II in plasma at Week 48 from baseline||||0.91
72529581|NCT02519777|144588824|SUPERIORITY|||||||0.86|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm C: MVC and DTG in change in Log10 sTNFr-II in plasma at Week 48 from baseline||||0.86
72529582|NCT02519777|144588824|SUPERIORITY|||||||0.94|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm B: DTG and placebo MVC and Arm C: MVC and DTG in change in Log10 sTNFr-II in plasma at Week 48 from baseline||||0.94
72529583|NCT02519777|144588825|SUPERIORITY|||||||0.7|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm B: DTG and placebo MVC in change in Log10 VCAM in plasma at Week 48 from baseline||||0.70
72529584|NCT02519777|144588825|SUPERIORITY|||||||0.28|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm C: MVC and DTG in change in Log10 VCAM in plasma at Week 48 from baseline||||0.28
72407746|NCT01147653|144323932|SUPERIORITY|||||||0.2|||||||Wilcoxon (Mann-Whitney)|||H0: The 12-month Participation and Physical Health change score is identically distributed in patients assigned Autologous UCB Reinfusion First and Placebo First.||||0.200
72407747|NCT01147653|144323932|SUPERIORITY|||||||0.225|||||||Wilcoxon (Mann-Whitney)|||H0: The 12-month Social wellbeing and acceptance change score is identically distributed in patients assigned Autologous UCB Reinfusion First and Placebo First.||||0.225
72407748|NCT01147653|144323935|SUPERIORITY|||||||0.29|||||||t-test, 2 sided|||||||0.290
72407749|NCT01147653|144323938|SUPERIORITY|||||||0.697|||||||t-test, 2 sided|||||||0.697
72407750|NCT01147653|144323939|SUPERIORITY|||||||0.912|||||||t-test, 2 sided|||||||0.912
72407751|NCT01147653|144323940|SUPERIORITY|||||||0.544|||||||t-test, 2 sided|||||||0.544
72407752|NCT01147653|144323941|SUPERIORITY|||||||0.76|||||||Wilcoxon (Mann-Whitney)|||||||0.76
72529585|NCT02519777|144588825|SUPERIORITY|||||||0.85|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm B: DTG and placebo MVC and Arm C: MVC and DTG in change in Log10 VCAM in plasma at Week 48 from baseline||||0.85
72529586|NCT02519777|144588826|SUPERIORITY|||||||0.99|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm B: DTG and placebo MVC in change in Log10 MIP-1 Beta in CSF at Week 48 from baseline||||0.99
72529587|NCT02519777|144588826|SUPERIORITY|||||||0.26|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm C: MVC and DTG in change in Log10 MIP-1 Beta in CSF at Week 48 from baseline||||0.26
72625595|NCT01968980|144780527|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|66.9|||||TWO_SIDED|95.0|30.32|147.43||||||Week 24: Odds ratio, associated 95% confidence interval and p-value from a Logistic Regression Model with fixed effects for treatment group,baseline value and geographical region was used for analysis.||147.43|30.32|
72407753|NCT01147653|144323942|SUPERIORITY|||||||0.76|||||||t-test, 2 sided|||||||0.76
72529588|NCT02519777|144588826|SUPERIORITY|||||||0.2|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm B: DTG and placebo MVC and Arm C: MVC and DTG in change in Log10 MIP-1 Beta in CSF at Week 48 from baseline||||0.20
72529589|NCT02519777|144588827|SUPERIORITY|||||||0.59|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm B: DTG and placebo MVC in change in Log10 IP-10 in CSF at Week 48 from baseline||||0.59
72529590|NCT02519777|144588827|SUPERIORITY|||||||0.39|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm C: MVC and DTG in change in Log10 IP-10 in CSF at Week 48 from baseline||||0.39
72529591|NCT02519777|144588827|SUPERIORITY|||||||0.8|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm B: DTG and placebo MVC and Arm C: MVC and DTG in change in Log10 IP-10 in CSF at Week 48 from baseline||||0.80
72407754|NCT01147653|144323943|SUPERIORITY|||||||0.176|||||||Wilcoxon (Mann-Whitney)|||||||0.176
72407755|NCT01147653|144323944|SUPERIORITY|||||||0.099|||||||t-test, 2 sided|||||||0.099
72407756|NCT01147653|144323945|SUPERIORITY|||||||0.131|||||||Wilcoxon (Mann-Whitney)|||||||0.131
72407757|NCT01147653|144323946|SUPERIORITY|||||||0.478|||||||t-test, 2 sided|||||||0.478
72407758|NCT01147653|144323947|SUPERIORITY|||||||0.029|||||||Wilcoxon (Mann-Whitney)|||||||0.029
72407759|NCT01147653|144323948|SUPERIORITY|||||||0.31|||||||t-test, 2 sided|||||||0.310
72407760|NCT01147653|144323950|SUPERIORITY|||||||0.233|||||||Wilcoxon (Mann-Whitney)|||H0: The population distribution of Modified Ashworth Scale scores is the same at 1-year post-infusion with autologous cord blood and placebo.||||0.233
72407761|NCT01147653|144323954|SUPERIORITY|||||||0.762|||||||Wilcoxon (Mann-Whitney)|||||||0.762
72407762|NCT01147653|144323955|SUPERIORITY|||||||0.05|||||||Wilcoxon (Mann-Whitney)|||H0: The population distribution of the 1-year GMFM-66 change score is the same for patients infused with Low and High doses of autologous umbilical cord blood.||||0.05
72407763|NCT01147653|144323955|SUPERIORITY|||||||0.15|||||||Wilcoxon (Mann-Whitney)|||H0: The population distribution of the 1-year GMFM-66 change score is the same for patients infused with High doses of autologous umbilical cord blood and Placebo.||||0.15
72407764|NCT01147653|144323955|SUPERIORITY|||||||0.21|||||||Wilcoxon (Mann-Whitney)|||H0: The population distribution of the 1-year GMFM-66 change score is the same for patients infused with Low doses of autologous umbilical cord blood and placebo.||||0.21
72407765|NCT01147653|144323956|SUPERIORITY||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||H0: The population distribution of differences between observed and expected GMFM-66 change scores at 1-year post-infusion is the same for patients receiving Low and High doses of autologous umbilical cord blood.||||<0.01
72407766|NCT01147653|144323957|SUPERIORITY|H0: The population distribution of the Peabody Gross Motor Quotient change score 1 year post-infusion with autologous umbilical cord blood is the same in patients receiving a Low infused dose and a High infused dose.||||||0.03|||||||Wilcoxon (Mann-Whitney)|||||||0.03
72407767|NCT01147653|144323958|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.04|TWO_SIDED|95.0|0.01|0.38|||Wilcoxon (Mann-Whitney)|||H0: The true mean 1-year change in normalized whole brain connectivity is the same in patients infused with Low and High doses of autologous umbilical cord blood.||0.38|0.01|0.04
72407768|NCT00280566|144323959|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0104|||||||Log Rank|alpha = 0.05 level of significance||Equality of Survival Curves across the treatment groups.||||0.0104
72625596|NCT01968980|144780527|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|22.8|||||TWO_SIDED|95.0|11.85|44.01||||||Week 52: Odds ratio, associated 95% confidence interval and p-value from a Logistic Regression Model with fixed effects for treatment group,baseline value and geographical region was used for analysis.||44.01|11.85|
72407769|NCT00280566|144323960|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0047|||||||Log Rank|No adjustment made for multiple comparisons||alpha = 0.05 level of significance||||0.0047
72407770|NCT00280566|144323961|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0205||||||No adjustment made for multiple comparisons|Log Rank|||alpha = 0.05 level of significance||||0.0205
72407771|NCT00280566|144323962|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.85|STANDARD_ERROR_OF_MEAN|0.55||0.1247|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 1: Difference in Change during Period 2 MMRM ANCOVA: center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.||||0.1247
72407772|NCT00280566|144323962|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.62||0.7515|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance|Mean Difference (Final Values) = Least Squares Mean|Week 2 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.||||0.7515
72625597|NCT01968980|144780528|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|200.8|||||TWO_SIDED|95.0|47.16|854.6||||||Week 12: Odds ratio, associated 95% confidence interval and p-value from a Logistic Regression Model with fixed effects for treatment group,baseline value and geographical region was used for analysis.||854.60|47.16|
72529592|NCT02519777|144588828|SUPERIORITY|||||||0.9|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm B: DTG and placebo MVC in change in Log10 Neopterin in CSF at Week 48 from baseline||||0.90
72529593|NCT02519777|144588828|SUPERIORITY|||||||0.14|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm C: MVC and DTG in change in Log10 Neopterin in CSF at Week 48 from baseline||||0.14
72529594|NCT02519777|144588828|SUPERIORITY|||||||0.49|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm B: DTG and placebo MVC and Arm C: MVC and DTG in change in Log10 Neopterin in CSF at Week 48 from baseline||||0.49
72529595|NCT02519777|144588829|SUPERIORITY|||||||0.52|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm B: DTG and placebo MVC in change in Log10 NFL in CSF at Week 48 from baseline||||0.52
72529596|NCT02519777|144588829|SUPERIORITY|||||||0.99|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm C: MVC and DTG in change in Log10 NFL in CSF at Week 48 from baseline||||0.99
72529597|NCT02519777|144588829|SUPERIORITY|||||||0.54|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm B: DTG and placebo MVC and Arm C: MVC and DTG in change in Log10 NFL in CSF at Week 48 from baseline||||0.54
72529598|NCT02364999|144588851|EQUIVALENCE|Calculated based on 2-sided Miettinen and Nurminen method without strata for risk difference for confirmed response. EU equivalence margins (95% CI in -13% to 13%).|Risk Difference (RD)|0.6531|||||TWO_SIDED|95.0|-6.608|7.9082|||||PF-06439535 vs Bevacizumab-EU|||7.9082|-6.6080|
72529599|NCT02364999|144588851|EQUIVALENCE|Calculated based on 2-sided Miettinen and Nurminen method without strata for risk ratio for confirmed response. US equivalence margins (90% CI in 0.73 to 1.37).|Risk Ratio (RR)|1.0146|||||TWO_SIDED|90.0|0.8856|1.1625|||||PF-06439535 vs Bevacizumab-EU|||1.1625|0.8856|
72529600|NCT02364999|144588851|EQUIVALENCE|Calculated based on 2-sided Miettinen and Nurminen method without strata for risk ratio for confirmed response. Japan equivalence margins (95% CI in 0.729 to 1.371).|Risk Ratio (RR)|1.0146|||||TWO_SIDED|95.0|0.8628|1.1933|||||PF-06439535 vs Bevacizumab-EU|||1.1933|0.8628|
72529601|NCT02364999|144588854|OTHER|Hazard ratio of PF-06439535 versus Bevacizumab-EU; a hazard ratio =1 indicated no difference in progressive disease(PD)/death between 2 reporting groups; \>1 indicated an increase in PD/death in PF-06439535; \<1 indicated an increase in PD/death in bevacizumab-EU.|Hazard Ratio (HR)|0.8||||0.1077|TWO_SIDED|95.0|0.608|1.051|||Log Rank|Stratified by smoking, sex and region.||||1.051|0.608|0.1077
72529602|NCT02364999|144588855|OTHER|Hazard ratio of PF-06439535 versus Bevacizumab-EU; a hazard ratio =1 indicated no difference in progressive disease(PD)/death between 2 reporting groups; \>1 indicated an increase in PD/death in PF-06439535; \<1 indicated an increase in PD/death in bevacizumab-EU.|Hazard Ratio (HR)|0.931||||0.4492||95.0|0.777|1.116|||Log Rank|Stratified by smoking, sex and region.||||1.116|0.777|0.4492
72625598|NCT01968980|144780528|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|228.0|||||TWO_SIDED|95.0|51.95|1000.39||||||Week 24: Odds ratio, associated 95% confidence interval and p-value from a Logistic Regression Model with fixed effects for treatment group,baseline value and geographical region was used for analysis.||1000.39|51.95|
72407773|NCT00280566|144323962|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.63|STANDARD_ERROR_OF_MEAN|0.62||0.3074|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance|Mean Difference (Final Values) = Least Squares Mean|Week 4 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.||||0.3074
72407774|NCT00280566|144323962|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.25|STANDARD_ERROR_OF_MEAN|0.71||0.0758|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 8 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.||||0.0758
72407775|NCT00280566|144323962|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.98|STANDARD_ERROR_OF_MEAN|0.82||0.0162|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 12 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.||||0.0162
72407776|NCT00280566|144323962|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.01|STANDARD_ERROR_OF_MEAN|0.83||0.0003|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance|Mean Difference (Final Values) = Least Squares Mean|Week 16 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.||||0.0003
72529603|NCT02364999|144588856|OTHER|Hazard ratio of PF-06439535 versus Bevacizumab-EU; a hazard ratio =1 indicated no difference in progressive disease(PD)/death between 2 reporting groups; \>1 indicated an increase in PD/death in PF-06439535; \<1 indicated an increase in PD/death in bevacizumab-EU.|Hazard Ratio (HR)|0.918||||0.4726|TWO_SIDED|95.0|0.729|1.157|||Log Rank|Stratified by smoking, sex and region.||||1.157|0.729|0.4726
72529604|NCT01234337|144588860|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.973|||=|0.405618|TWO_SIDED|95.0|0.779|1.217||One-sided p-value from log rank test (stratified per randomization as in interactive voice response system \[IVRS\]).|Log Rank|||PFS was compared using a stratified log-rank test with a one-sided alpha of 0.005, stratified by region, hormone receptor status, number of previous chemotherapies for metastatic disease. The hazard ratio (sorafenib + capecitabine / placebo + capecitabine) and its 95 percent (%) CIs were calculated using the Cox model, stratified by the above factors. A Hazard ratio of less than (\<) 1 indicates superiority of Sorafenib + Capecitabine over Placebo + Capecitabine.||1.217|0.779|=0.405618
72529605|NCT01234337|144588861|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.195|||=|0.930088|TWO_SIDED|95.0|0.943|1.513||One-sided p-value from log rank test (stratified per randomization as in IVRS). OS was compared using a stratified log-rank test, stratified by region, hormone receptor status, number of previous chemotherapies for metastatic disease.|Log Rank||The hazard ratio (sorafenib + capecitabine / placebo + capecitabine) and its 95% CIs were calculated using the Cox model, stratified by randomization factors.|At the time of PFS final analysis, it was OS interim analysis (IA) with 285 total death events. According to protocol specified O'Brien-Fleming type alpha spending function and 285 death events at IA, the prespecified alpha for this analysis was 0.0075 (one-sided). A Hazard ratio \< 1 indicates superiority of Sorafenib+Capecitabine over Placebo+Capecitabine.||1.513|0.943|=0.930088
72529606|NCT01234337|144588862|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.91|||=|0.2105|TWO_SIDED|95.0|0.723|1.146||One-sided p-value from log rank test (stratified per randomization as in IVRS).|Log Rank||The hazard ratio (sorafenib + capecitabine / placebo + capecitabine) and its 95% CIs were calculated using the Cox model, stratified by the above factors.|TTP was compared using a stratified log-rank test with a one-sided alpha of 0.025, stratified by region, hormone receptor status, number of previous chemotherapies for metastatic disease. A Hazard ratio \<1 indicates superiority of Sorafenib+Capecitabine over Placebo+Capecitabine.||1.146|0.723|=0.2105
72529607|NCT01234337|144588863|SUPERIORITY_OR_OTHER||Percent Difference|1.93|||=|0.257412|TWO_SIDED|95.0|-3.9|7.77||One-sided p-value from Cochran Mantel-Haenszel test (stratified per randomization as in IVRS)|Cochran-Mantel-Haenszel|||ORR and 95% CI based on Cochran Mantel-Haenszel Test stratified by region, hormone receptor status, number of previous chemotherapies for metastatic disease. Difference = (Placebo + Capecitabine) - (Sorafenib + Capecitabine).||7.77|-3.9|=0.257412
72529608|NCT01234337|144588864|SUPERIORITY_OR_OTHER||Percent Difference|-2.34|||=|0.284674|TWO_SIDED|95.0|-10.4|5.72||One-sided p-value from Cochran-Mantel-Haenszel test (stratified per randomization as in IVRS).|Cochran-Mantel-Haenszel|||"DCR and 95% CI based on general association Cochran-Mantel-Haenszel statistic with one-sided alpha of 0.025 stratified by number of prior chemotherapies for metastatic disease, hormone receptor status, and region. Difference = Placebo + Capecitabine - Sorafenib + Capecitabine."||5.72|-10.4|=0.284674
72529609|NCT01234337|144588866|SUPERIORITY_OR_OTHER||LSM Difference|-0.441|||||TWO_SIDED|95.0|-0.967|0.086||||||Estimate of Difference (least squares mean \[LSM\] difference) = (Sorafenib + Capecitabine) - (Placebo + Capecitabine). The difference between the two treatment groups was evaluated with an analysis of covariance model using the baseline score and the same stratification factors as used for randomization (IVRS) as covariates.||0.086|-0.967|
72529610|NCT01234337|144588867|SUPERIORITY_OR_OTHER||LSM Difference|-0.025|||||TWO_SIDED|95.0|-0.053|0.002||||||Estimate of Difference (least squares mean \[LSM\] difference) = (Sorafenib + Capecitabine) - (Placebo + Capecitabine). The difference between the two treatment groups was evaluated with an analysis of covariance model using the baseline score and the same stratification factors as used for randomization (IVRS) as covariates.||0.002|-0.053|
72529611|NCT01234337|144588868|SUPERIORITY_OR_OTHER||LSM Difference|-1.696|||||TWO_SIDED|95.0|-3.619|0.227||||||Estimate of Difference (least squares mean \[LSM\] difference) = (Sorafenib + Capecitabine) - (Placebo + Capecitabine). The difference between the two treatment groups was evaluated with an analysis of covariance model using the baseline score and the same stratification factors as used for randomization (IVRS) as covariates.||0.227|-3.619|
72529612|NCT01234337|144588869|SUPERIORITY_OR_OTHER||Ratio of geometric least square means|1.14|||||TWO_SIDED|90.0|0.92|1.4||||||Statistical analysis for Cmax: 5-fluorouracil||1.40|0.92|
72529613|NCT01234337|144588869|SUPERIORITY_OR_OTHER||Ratio of geometric least square means|1.29|||||TWO_SIDED|90.0|1.07|1.56||||||Statistical analysis for Cmax: Capecitabine||1.56|1.07|
72529614|NCT01234337|144588870|SUPERIORITY_OR_OTHER||Ratio of geometric least square means|1.11|||||TWO_SIDED|90.0|0.95|1.3||||||Statistical analysis for AUC(0-tlast): 5-fluorouracil||1.30|0.95|
72529615|NCT01234337|144588870|SUPERIORITY_OR_OTHER||Ratio of geometric least square means|1.39|||||TWO_SIDED|90.0|1.22|1.58||||||Statistical analysis for AUC(0-tlast): Capecitabine||1.58|1.22|
72529616|NCT02430389|144588915|SUPERIORITY_OR_OTHER|||||||0.0575|TWO_SIDED||||||t-test, 2 sided|||||||.0575
72529617|NCT02430389|144588916|SUPERIORITY_OR_OTHER|||||||0.348|TWO_SIDED||||||t-test, 2 sided|||||||.348
72529618|NCT01241318|144588929|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|1.12|||||TWO_SIDED|95.0|0.88|1.44|||||The chlorhexidine arm is the numerator and dry cord care arm is the denominator in the relative risk calculation. Generalised estimating equation models were used to adjust for cluster randomized design.|||1.44|0.88|
72529619|NCT01241318|144588930|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|1.12|||||TWO_SIDED|95.0|0.86|1.47|||||Generalized estimating equation models adjusting for cluster-randomized design were used.|||1.47|0.86|
72529620|NCT01241318|144588931|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.73|||||TWO_SIDED|95.0|0.47|1.13|||||Generalized estimating equation models adjusting for cluster-randomized design were used.|||1.13|0.47|
72529621|NCT01032265|144588944|SUPERIORITY_OR_OTHER_LEGACY|||||||0.27||95.0|||||Mixed Models Analysis|||analysis between groups||||0.27
72529622|NCT01032265|144588945|SUPERIORITY_OR_OTHER_LEGACY|||||||0.52||95.0|||||Mixed Models Analysis|||analysis between groups||||0.52
72529623|NCT01032265|144588946|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3||95.0|||||Mixed Models Analysis|||analysis between groups||||0.30
72529624|NCT01032265|144588947|SUPERIORITY_OR_OTHER_LEGACY|||||||0.02||95.0|||||Wilcoxon (Mann-Whitney)|||analysis between groups||||0.02
72529625|NCT01032265|144588948|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||Wilcoxon (Mann-Whitney)|||analysis between groups||||<0.001
72571845|NCT02912650|144671807|SUPERIORITY_OR_OTHER||LS Mean Difference|0.71|||<|0.001|TWO_SIDED|95.0|0.51|0.91|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.91|0.51|<0.001
72571846|NCT02912650|144671807|SUPERIORITY_OR_OTHER||LS Mean Difference|0.98|||<|0.001|TWO_SIDED|95.0|0.7|1.27|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.27|0.70|<0.001
72571847|NCT02912650|144671807|SUPERIORITY_OR_OTHER||LS Mean Difference|0.58|||<|0.001|TWO_SIDED|95.0|0.29|0.86|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.86|0.29|<0.001
72571848|NCT02912650|144671807|SUPERIORITY_OR_OTHER||LS Mean Difference|0.41|||<|0.001|TWO_SIDED|95.0|0.21|0.61|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.61|0.21|<0.001
72571849|NCT02912650|144671807|SUPERIORITY_OR_OTHER||LS Mean Difference|1.1|||<|0.001|TWO_SIDED|95.0|0.81|1.38|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.38|0.81|<0.001
72571850|NCT02912650|144671807|SUPERIORITY_OR_OTHER||LS Mean Difference|0.25||||0.014|TWO_SIDED|95.0|0.05|0.45|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.45|0.05|0.014
72407777|NCT00280566|144323962|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.21|STANDARD_ERROR_OF_MEAN|0.98||0.0242|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 20 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.||||0.0242
72407778|NCT00280566|144323962|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.71|STANDARD_ERROR_OF_MEAN|0.71||0.0161|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 24 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.||||0.0161
72571851|NCT02912650|144671807|SUPERIORITY_OR_OTHER||LS Mean Difference|0.66|||<|0.001|TWO_SIDED|95.0|0.45|0.86|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.86|0.45|<0.001
72571852|NCT02912650|144671807|SUPERIORITY_OR_OTHER||LS Mean Difference|0.85|||<|0.001|TWO_SIDED|95.0|0.56|1.13|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.13|0.56|<0.001
72571853|NCT02912650|144671807|SUPERIORITY_OR_OTHER||LS Mean Difference|0.44||||0.003|TWO_SIDED|95.0|0.15|0.73|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.73|0.15|0.003
72571854|NCT02912650|144671807|SUPERIORITY_OR_OTHER||LS Mean Difference|0.41|||<|0.001|TWO_SIDED|95.0|0.21|0.61|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.61|0.21|<0.001
72571855|NCT02912650|144671807|SUPERIORITY_OR_OTHER||LS Mean Difference|0.91|||<|0.001|TWO_SIDED|95.0|0.62|1.2|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.20|0.62|<0.001
72571856|NCT02912650|144671807|SUPERIORITY_OR_OTHER||LS Mean Difference|0.21||||0.041|TWO_SIDED|95.0|0.01|0.42|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.42|0.01|0.041
72571857|NCT02912650|144671807|SUPERIORITY_OR_OTHER||LS Mean Difference|0.56|||<|0.001|TWO_SIDED|95.0|0.35|0.76|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.76|0.35|<0.001
72571858|NCT02912650|144671807|SUPERIORITY_OR_OTHER||LS Mean Difference|0.7|||<|0.001|TWO_SIDED|95.0|0.41|0.99|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.99|0.41|<0.001
72571859|NCT02912650|144671807|SUPERIORITY_OR_OTHER||LS Mean Difference|0.35||||0.018|TWO_SIDED|95.0|0.06|0.65|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.65|0.06|0.018
72571860|NCT02912650|144671807|SUPERIORITY_OR_OTHER||LS Mean Difference|0.34||||0.001|TWO_SIDED|95.0|0.14|0.55|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.55|0.14|0.001
72571861|NCT02912650|144671807|SUPERIORITY_OR_OTHER||LS Mean Difference|0.76|||<|0.001|TWO_SIDED|95.0|0.48|1.05|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.05|0.48|<0.001
72571862|NCT02912650|144671807|SUPERIORITY_OR_OTHER||LS Mean Difference|0.2||||0.045|TWO_SIDED|95.0|0.0|0.4|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.40|0.00|0.045
72571863|NCT02912650|144671807|SUPERIORITY_OR_OTHER||LS Mean Difference|0.44|||<|0.001|TWO_SIDED|95.0|0.24|0.64|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.64|0.24|<0.001
72571864|NCT02912650|144671807|SUPERIORITY_OR_OTHER||LS Mean Difference|0.56|||<|0.001|TWO_SIDED|95.0|0.28|0.84|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.84|0.28|< 0.001
72571865|NCT02912650|144671807|SUPERIORITY_OR_OTHER||LS Mean Difference|0.32||||0.027|TWO_SIDED|95.0|0.04|0.61|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.61|0.04|0.027
72571866|NCT02912650|144671807|SUPERIORITY_OR_OTHER||LS Mean Difference|0.24||||0.02|TWO_SIDED|95.0|0.04|0.44|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.44|0.04|0.020
72571867|NCT02912650|144671807|SUPERIORITY_OR_OTHER||LS Mean Difference|0.57|||<|0.001|TWO_SIDED|95.0|0.29|0.85|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.85|0.29|<0.001
72571868|NCT02912650|144671807|SUPERIORITY_OR_OTHER||LS Mean Difference|0.09||||0.374|TWO_SIDED|95.0|-0.11|0.28|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.28|-0.11|0.374
72529626|NCT01032265|144588949|SUPERIORITY_OR_OTHER_LEGACY|||||||0.23||95.0|||||negative binomial regression|||analysis between groups||||0.23
72529627|NCT01032265|144588950|SUPERIORITY_OR_OTHER_LEGACY|||||||0.01||95.0|||||Wilcoxon (Mann-Whitney)|||analysis between groups||||0.01
72529628|NCT02728804|144588962|SUPERIORITY||Hazard Ratio (HR)|0.93||||0.65|TWO_SIDED|95.0|0.66|1.29|||Regression, Cox|Covariate adjustment for insurance status, education, and sex.||||1.29|0.66|0.65
72529629|NCT02728804|144588963|SUPERIORITY||Hazard Ratio (HR)|1.06||||0.7|TWO_SIDED|95.0|0.79|1.43|||Regression, Cox|Covariate adjustment for insurance status, education, and sex.||||1.43|0.79|0.70
72529630|NCT02728804|144588964|SUPERIORITY||Hazard Ratio (HR)|0.98||||0.87|TWO_SIDED|95.0|0.73|1.31|||Regression, Cox|Covariate adjustment for insurance status, education, and sex.||||1.31|0.73|0.87
72529631|NCT02728804|144588965|SUPERIORITY||Hazard Ratio (HR)|0.66||||0.01|TWO_SIDED|95.0|0.48|0.92|||Regression, Cox|Covariate adjustment for insurance status, education, and sex.||||0.92|0.48|0.01
72529632|NCT02728804|144588966|SUPERIORITY||Hazard Ratio (HR)|1.33||||0.1|TWO_SIDED|95.0|0.95|1.87|||Regression, Cox|Covariate adjustment for insurance status, education, and sex.||||1.87|0.95|0.10
72529633|NCT02728804|144588966|SUPERIORITY||Hazard Ratio (HR)|1.92||||0.002|TWO_SIDED|95.0|1.28|2.89|||Regression, Cox|Covariate adjustment for insurance status, education, and sex.||||2.89|1.28|0.002
72529634|NCT02514889|144588985|SUPERIORITY||Mean Difference (Final Values)|-2.11|STANDARD_ERROR_OF_MEAN|2.05||0.3|TWO_SIDED|95.0|-6.12|1.91||a priori threshold is p = .017, so that experiment-wide critical alpha would be p = .05.|Mixed Models Analysis|Covariates: sex, age, ethnicity, marital status and educational attainment|Difference in differences interaction term is the product of assessment period (baseline, 6-months, 12-months) and experimental condition (MyPlate, Calorie Counting).|||1.91|-6.12|0.30
72407779|NCT00280566|144323963|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.24|STANDARD_ERROR_OF_MEAN|0.09||0.0088|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 1 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.||||0.0088
72529635|NCT02514889|144588986|EQUIVALENCE|p-value \>0.20 would be considered equivalent.|Mean Difference (Final Values)|2.59|STANDARD_ERROR_OF_MEAN|1.39||0.06|TWO_SIDED|95.0|-0.1342|5.3228|||Mixed Models Analysis|Covariates included age, sex, ethnicity, educational attainment and marital status||||5.3228|-0.1342|0.06
72529636|NCT02514889|144588987|SUPERIORITY||Mean Difference (Net)|-1.37|STANDARD_ERROR_OF_MEAN|2.55||0.504|TWO_SIDED|95.0|-6.37|3.63|||Mixed Models Analysis|Covariates included: age, sex, ethnicity, educational attainment and marital status|Difference in differences interaction term is the product of assessment period (baseline, 6-months, 12-months) and experimental condition (MyPlate, Calorie Counting).|||3.63|-6.37|0.504
72529637|NCT02514889|144588988|SUPERIORITY|Difference in differences|Mean Difference (Net)|-1.88|STANDARD_ERROR_OF_MEAN|2.35||0.3|TWO_SIDED|95.0|-6.47|2.74|||Mixed Models Analysis|Covariates included: age, sex, ethnicity, educational attainment, marital status|The difference in differences interaction term is the product of assessment period (baseline, 6-months, 12-months) and experimental condition (MyPlate, Calorie Counting)|||2.74|-6.47|0.30
72529638|NCT02514889|144588989|SUPERIORITY||Mean Difference (Net)|0.46|STANDARD_ERROR_OF_MEAN|0.99||0.64|TWO_SIDED|95.0|-1.47|2.39|||Mixed Models Analysis||The differences in difference interaction term consists of the product of assessment intervals (baseline, 6-months, 12-months) and experimental condition (MyPlate, Calorie Counting)|||2.39|-1.47|0.640
72529639|NCT02514889|144588990|EQUIVALENCE|For the comparison conditions to be equivalent, as predicted, the critical alpha was set at P \> 0.20.|Mean Difference (Net)|-0.04|STANDARD_ERROR_OF_MEAN|0.135||0.747|TWO_SIDED|95.0|-0.31|0.22|||Mixed Models Analysis|Covariates included: age, sex, ethnicity, educational attainment and marital status|The differences in difference interaction term consists of the product of assessment intervals (baseline, 6-months, 12-months) and experimental condition (MyPlate, Calorie Counting)|||0.22|-.31|0.747
72529640|NCT02514889|144588991|EQUIVALENCE|For the comparison conditions to be judged equivalent, as predicted, the critical p-value was set to P \>.20|Mean Difference (Net)|0.14|STANDARD_ERROR_OF_MEAN|0.51||0.776|TWO_SIDED|95.0|-0.85|1.14|||Mixed Models Analysis|Covariates included: age, sex, ethnicity, educational attainment and marital status|The differences in difference interaction term consists of the product of assessment intervals (baseline, 6-months, 12-months) and experimental condition (MyPlate, Calorie Counting)|||1.14|-0.85|0.776
72529641|NCT02475564|144588992|SUPERIORITY_OR_OTHER|||||||0.7|||||||Mann-Whitney test|||A sample size of at least 21 patients per arm would be necessary to have a 90% chance of detecting, as significant at the 1% level, a difference of 3 points in a scale of 10 points, between both groups as the primary outcome, after 42 days of treatment.||||0.7
72529642|NCT02475564|144588993|SUPERIORITY_OR_OTHER|||||||0.1|||||||Mann-Whitney test|||||||0.1
72529643|NCT02475564|144588994|SUPERIORITY_OR_OTHER|||||||0.8|||||||Mann-Whitney test|||||||0.8
72529644|NCT02705755|144589008|SUPERIORITY||Least Squares Mean Difference|-4.4||||0.0399|TWO_SIDED|95.0|-8.57|-0.23||P-values were reported without multiplicity adjustment.|Repeated-measures Mixed-effect Model|||Least squares mean differences were calculated based on a repeated-measures mixed-effect model with change from baseline at different time points as the dependent variable, the treatment group (TD-9855 or placebo), time point, baseline and the interaction between the treatment group and time point as fixed factors. A compound symmetry was used as the variance-covariance structure.||-0.23|-8.57|0.0399
72529645|NCT03479203|144589039|OTHER|T-Test followed by Bonferroni post-hoc analysis.|Mean Difference (Final Values)|1.96|STANDARD_DEVIATION|1.5||0.05|TWO_SIDED|95.0|1.0|6.0|||t-test, 2 sided|||"Blood assessed for C-reactive protein (CRP), soluble intercellular adhesion molecule (sICAM), the high mobility group box-1 (HMGB1), the NLRP3 inflammasome, and nitrates (NOx for nitric oxide) pre- and post-vaping. CRP, sICAM HMGB1 and NLRP3 is in ng/ml blood and NOx is in nanomol/ml. These numbers were weighted to obtain an inflammation index in blood. This index represents the fold increase over pre-vaping values."||6|1|0.05
72529646|NCT03419741|144589047|OTHER|We plan to enroll 20 participants within one year. Eleven participants were enrolled. 11/20 = 55% completed the number of enrollment.|%|11.0|||||TWO_SIDED||||||percentage|||||||
72529647|NCT01091116|144589090|SUPERIORITY_OR_OTHER|||||||0.5263||95.0|||||ANCOVA|||Tests of Fixed Effects for the primary efficacy variable including baseline treatment and visit (from Visit 3 to Visit 5) as covariates||||0.5263
72529648|NCT02194699|144589104|SUPERIORITY|The null hypothesis was that the exacerbation rate during the 52-week double-blind treatment period on tralokinumab was equal to the corresponding exacerbation rate on placebo.|Rate ratio|0.84||||0.4656|TWO_SIDED|95.0|0.53|1.34|||Negative binomial||Covariates in the model included treatment group, geographical region, age group, periostin group at baseline and number of exacerbations in the year before the study.|"Comparison of AAER (rate ratio): Biomarker positive population; Tralo 300 mg Q2W vs placebo.~A variable for the biomarker population (positive, negative) as well as a treatment-by-biomarker population interaction term was included in the analysis model."||1.34|0.53|0.4656
72529649|NCT02194699|144589104|SUPERIORITY|The null hypothesis was that the exacerbation rate during the 52-week double-blind treatment period on tralokinumab was equal to the corresponding exacerbation rate on placebo.|Rate ratio|1.13||||0.4126|TWO_SIDED|95.0|0.85|1.5|||Negative binomial||Covariates in the model included treatment group, geographical region, age group, periostin group at baseline and number of exacerbations in the year before the study.|"Comparison of AAER (rate ratio): Biomarker negative population; Tralo 300 mg Q2W vs placebo.~A variable for the biomarker population (positive, negative) as well as a treatment-by-biomarker population interaction term was included in the analysis model."||1.50|0.85|0.4126
72529650|NCT02194699|144589104|SUPERIORITY|The null hypothesis was that the exacerbation rate during the 52-week double-blind treatment period on tralokinumab was equal to the corresponding exacerbation rate on placebo.|Rate reduction|15.83||||0.4656|TWO_SIDED|95.0|-33.71|47.01|||Negative binominal||Covariates in the model included treatment group, geographical region, age group, periostin group at baseline and number of exacerbations in the year before the study.|"Comparison of AAER (rate reduction): Biomarker positive population; Tralo 300 mg Q2W vs placebo.~A variable for the biomarker population (positive, negative) as well as a treatment-by-biomarker population interaction term was included in the analysis model."||47.01|-33.71|0.4656
72529651|NCT02194699|144589104|SUPERIORITY|The null hypothesis was that the exacerbation rate during the 52-week double-blind treatment period on tralokinumab was equal to the corresponding exacerbation rate on placebo.|Rate ratio|1.03||||0.8027|TWO_SIDED|95.0|0.81|1.31|||Negative binomial||Covariates in the model included treatment group, geographical region, age group, periostin group at baseline and number of exacerbations in the year before the study.|Comparison of AAER (rate ratio): FAS population; Tralo 300 mg Q2W vs placebo.||1.31|0.81|0.8027
72529652|NCT02194699|144589104|SUPERIORITY|The null hypothesis was that the exacerbation rate during the 52-week double-blind treatment period on tralokinumab was equal to the corresponding exacerbation rate on placebo.|Rate reduction|-3.14||||0.8027|TWO_SIDED|95.0|-31.46|19.08|||Negative binominal||Covariates in the model included treatment group, geographical region, age group, periostin group at baseline and number of exacerbations in the year before the study.|Comparison of AAER (rate reduction): FAS population; Tralo 300 mg Q2W vs placebo.||19.08|-31.46|0.8027
72529653|NCT02194699|144589105|SUPERIORITY||Least square (LS) Mean difference|1.86||||0.6033|TWO_SIDED|95.0|-5.16|8.88|||Repeated measures analysis||Fixed categorical effects of treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as a fixed covariate.|"Comparison of % change from baseline in pre-dose/pre-BD FEV1 at Week 52: Biomarker positive population; Tralo 300 mg Q2W vs placebo.~Restricted maximum likelihood (REML) based repeated measures analysis on patients with a baseline pre-dose/pre-BD FEV1 assessment.~A variable for the biomarker population (positive, negative) as well as a treatment-by-biomarker population interaction term and a 3-way biomarker population-by-treatment-by-visit interaction term was included in the analysis model."||8.88|-5.16|0.6033
72529654|NCT02194699|144589105|SUPERIORITY||LS Mean difference|3.37||||0.1276|TWO_SIDED|95.0|-0.97|7.7|||Repeated measures analysis||Fixed categorical effects of treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as a fixed covariate.|"Comparison of % change from baseline in pre-dose/pre-BD FEV1 at Week 52: Biomarker negative population; Tralo 300 mg Q2W vs placebo.~REML based repeated measures analysis on patients with a baseline pre-dose/pre-BD FEV1 assessment.~A variable for the biomarker population (positive, negative) as well as a treatment-by-biomarker population interaction term and a 3-way biomarker population-by-treatment-by-visit interaction term was included in the analysis model."||7.70|-0.97|0.1276
72529655|NCT02194699|144589105|SUPERIORITY||LS Mean difference|2.95||||0.1164|TWO_SIDED|95.0|-0.73|6.62|||Repeated measures analysis||Fixed categorical effects of treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as a fixed covariate.|Comparison of % change from baseline in pre-dose/pre-BD FEV1 at Week 52: FAS population; Tralo 300 mg Q2W vs placebo. REML based repeated measures analysis on patients with a baseline pre-dose/pre-BD FEV1 assessment||6.62|-0.73|0.1164
72529656|NCT02194699|144589106|SUPERIORITY||LS Mean difference|-0.2||||0.1456|TWO_SIDED|95.0|-0.47|0.07|||Repeated measures analysis||Fixed categorical effects of baseline asthma symptom score, treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as a fixed covariate.|"Comparison of mean change from baseline in total asthma symptom score at Week 52: Biomarker positive population; Tralo 300 mg Q2W vs placebo.~REML based repeated measures analysis. A variable for the biomarker population (positive, negative) as well as a treatment-by-biomarker population interaction term and a 3-way biomarker population-by-treatment-by-visit interaction term was included in the analysis model."||0.07|-0.47|0.1456
72529657|NCT02194699|144589106|SUPERIORITY||LS Mean difference|0.04||||0.6548|TWO_SIDED|95.0|-0.13|0.2|||Repeated measures analysis||Fixed categorical effects of baseline asthma symptom score, treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as a fixed covariate.|"Comparison of mean change from baseline in total asthma symptom score at Week 52: Biomarker negative population; Tralo 300 mg Q2W vs placebo.~REML based repeated measures analysis. A variable for the biomarker population (positive, negative) as well as a treatment-by-biomarker population interaction term and a 3-way biomarker population-by-treatment-by-visit interaction term was included in the analysis model."||0.20|-0.13|0.6548
72571869|NCT02912650|144671807|SUPERIORITY_OR_OTHER||LS Mean Difference|0.34|||<|0.001|TWO_SIDED|95.0|0.14|0.54|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.54|0.14|<0.001
72407780|NCT00280566|144323963|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.11|STANDARD_ERROR_OF_MEAN|0.13||0.3677|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 2 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.||||0.3677
72407781|NCT00280566|144323963|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.18|STANDARD_ERROR_OF_MEAN|0.1||0.0734|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 4 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.||||0.0734
72529658|NCT02194699|144589106|SUPERIORITY||LS Mean difference|-0.04||||0.5763|TWO_SIDED|95.0|-0.18|0.1|||Repeated measures analysis||Fixed categorical effects of baseline asthma symptom score, treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as a fixed covariate.|Comparison of mean change from baseline in total asthma symptom score at Week 52: FAS population; Tralo 300 mg Q2W vs placebo. REML based repeated measures analysis.||0.10|-0.18|0.5763
72529659|NCT02194699|144589107|SUPERIORITY||LS Mean difference|0.27||||0.0874|TWO_SIDED|95.0|-0.04|0.57|||Repeated measures analysis||Fixed categorical effects of baseline AQLQ(S)+12 score, treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as a fixed covariate.|"Comparison of change in mean score from baseline for AQLQ(S)+12 at Week 52: Biomarker positive population; Tralo 300 mg Q2W vs placebo.~REML based repeated measures analysis. A variable for the biomarker population (positive, negative) as well as a treatment-by-biomarker population interaction term and a 3-way biomarker population-by-treatment-by-visit interaction term was included in the analysis model."||0.57|-0.04|0.0874
72529660|NCT02194699|144589107|SUPERIORITY||LS Mean difference|-0.01||||0.9083|TWO_SIDED|95.0|-0.2|0.17|||Repeated measures analysis||Fixed categorical effects of baseline AQLQ(S)+12 score, treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as a fixed covariate.|"Comparison of change in mean score from baseline for AQLQ(S)+12 at Week 52: Biomarker negative population; Tralo 300 mg Q2W vs placebo.~REML based repeated measures analysis. A variable for the biomarker population (positive, negative) as well as a treatment-by-biomarker population interaction term and a 3-way biomarker population-by-treatment-by-visit interaction term was included in the analysis model."||0.17|-0.20|0.9083
72529661|NCT02194699|144589107|SUPERIORITY||LS Mean difference|0.06||||0.4506|TWO_SIDED|95.0|-0.1|0.22|||Repeated measures analysis||Fixed categorical effects of baseline AQLQ(S)+12 score, treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as a fixed covariate.|Comparison of change in mean score from baseline for AQLQ(S)+12 at Week 52: FAS population; Tralo 300 mg Q2W vs placebo. REML based repeated measures analysis.||0.22|-0.10|0.4506
72529662|NCT02194699|144589108|SUPERIORITY||LS Mean difference|-0.27||||0.04|TWO_SIDED|95.0|-0.53|-0.01|||Repeated measures analysis||Fixed categorical effects of baseline ACQ-6 score, treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as a fixed covariate.|"Comparison of change in mean score from baseline for ACQ-6 at Week 52: Biomarker positive population; Tralo 300 mg Q2W vs placebo.~REML based repeated measures analysis. A variable for the biomarker population (positive, negative) as well as a treatment-by-biomarker population interaction term and a 3-way biomarker population-by-treatment-by-visit interaction term was included in the analysis model."||-0.01|-0.53|0.0400
72529663|NCT02194699|144589108|SUPERIORITY||LS Mean difference|0.0||||0.9735|TWO_SIDED|95.0|-0.16|0.16|||Repeated measures analysis||Fixed categorical effects of baseline ACQ-6 score, treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as a fixed covariate.|"Comparison of change in mean score from baseline for ACQ-6 at Week 52: Biomarker negative population; Tralo 300 mg Q2W vs placebo.~REML based repeated measures analysis. A variable for the biomarker population (positive, negative) as well as a treatment-by-biomarker population interaction term and a 3-way biomarker population-by-treatment-by-visit interaction term was included in the analysis model."||0.16|-0.16|0.9735
72529664|NCT02194699|144589108|SUPERIORITY||LS Mean difference|-0.08||||0.2432|TWO_SIDED|95.0|-0.21|0.05|||Repeated measures analysis||Fixed categorical effects of baseline ACQ-6 score, treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as a fixed covariate.|Comparison of change in mean score from baseline for ACQ-6 at Week 52: FAS population; Tralo 300 mg Q2W vs placebo. REML based repeated measures analysis.||0.05|-0.21|0.2432
72529665|NCT02194699|144589109|SUPERIORITY||Rate ratio|0.39||||0.0576|TWO_SIDED|95.0|0.15|1.03|||Negative binomial||Covariates in the model included treatment group, geographical region, age group, periostin group at baseline and number of exacerbations resulting in hospitalisation or ER treatment (yes/no) in the year before the study.|"Comparison of AAER associated with an ER/UC visit or hospitalisation: Biomarker positive population; Tralo 300 mg Q2W vs placebo.~A variable for the biomarker population (positive, negative) as well as a treatment-by-biomarker population interaction term was included in the analysis model."||1.03|0.15|0.0576
72407782|NCT00280566|144323963|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.11||0.9166|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 8 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.||||0.9166
72407783|NCT00280566|144323963|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.14|STANDARD_ERROR_OF_MEAN|0.13||0.2791|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 12 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.||||0.2791
72529666|NCT02194699|144589109|SUPERIORITY||Rate ratio|0.83||||0.5249|TWO_SIDED|95.0|0.46|1.48|||Negative binomial||Covariates in the model included treatment group, geographical region, age group, periostin group at baseline and number of exacerbations resulting in hospitalisation or ER treatment (yes/no) in the year before the study.|"Comparison of AAER associated with an ER/UC visit or hospitalisation: Biomarker negative population; Tralo 300 mg Q2W vs placebo.~A variable for the biomarker population (positive, negative) as well as a treatment-by-biomarker population interaction term was included in the analysis model."||1.48|0.46|0.5249
72529667|NCT02194699|144589109|SUPERIORITY||Rate ratio|0.67||||0.1155|TWO_SIDED|95.0|0.41|1.1|||Negative binomial||Covariates in the model included treatment group, geographical region, age group, periostin group at baseline and number of exacerbations resulting in hospitalisation or ER treatment (yes/no) in the year before the study.|Comparison of AAER associated with an ER/UC visit or hospitalisation: FAS population; Tralo 300 mg Q2W vs placebo.||1.10|0.41|0.1155
72529668|NCT02194699|144589111|SUPERIORITY||LS Mean difference|-0.95||||0.036|TWO_SIDED|95.0|-1.85|-0.06|||Repeated measures analysis||Fixed categorical effects of baseline rescue medication use, treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as a fixed covariate.|"Comparison of mean change from baseline in rescue medication use at Week 52: Biomarker positive population; Tralo 300 mg Q2W vs placebo.~REML based repeated measures analysis. A variable for the biomarker population (positive, negative) as well as a treatment-by-biomarker population interaction term and a 3-way biomarker population-by-treatment-by-visit interaction term was included in the analysis model."||-0.06|-1.85|0.0360
72529669|NCT02194699|144589111|SUPERIORITY||LS Mean difference|0.15||||0.5864|TWO_SIDED|95.0|-0.4|0.7|||Repeated measures analysis||Fixed categorical effects of baseline rescue medication use, treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as a fixed covariate.|"Comparison of mean change from baseline in rescue medication use at Week 52: Biomarker negative population; Tralo 300 mg Q2W vs placebo.~REML based repeated measures analysis. A variable for the biomarker population (positive, negative) as well as a treatment-by-biomarker population interaction term and a 3-way biomarker population-by-treatment-by-visit interaction term was included in the analysis model."||0.70|-0.40|0.5864
72529670|NCT02194699|144589111|SUPERIORITY||LS Mean difference|-0.17||||0.4689|TWO_SIDED|95.0|-0.63|0.29|||Repeated measures analysis||Fixed categorical effects of baseline rescue medication use, treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as a fixed covariate.|Comparison of mean change from baseline in rescue medication use at Week 52: FAS population; Tralo 300 mg Q2W vs placebo. REML based repeated measures analysis.||0.29|-0.63|0.4689
72529671|NCT02194699|144589112|SUPERIORITY||LS Mean difference|6.15||||0.5094|TWO_SIDED|95.0|-12.13|24.43|||Repeated measures analysis||Fixed categorical effects of baseline PEF (morning), treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as a fixed covariate.|"Comparison of mean change from baseline in morning PEF at Week 52: Biomarker positive population; Tralo 300 mg Q2W vs placebo.~REML based repeated measures analysis. A variable for the biomarker population (positive, negative) as well as a treatment-by-biomarker population interaction term and a 3-way biomarker population-by-treatment-by-visit interaction term was included in the analysis model."||24.43|-12.13|0.5094
72529672|NCT02194699|144589112|SUPERIORITY||LS Mean difference|3.02||||0.5984|TWO_SIDED|95.0|-8.22|14.26|||Repeated measures analysis||Fixed categorical effects of baseline PEF (morning), treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as a fixed covariate.|"Comparison of mean change from baseline in morning PEF at Week 52: Biomarker negative population; Tralo 300 mg Q2W vs placebo.~REML based repeated measures analysis. A variable for the biomarker population (positive, negative) as well as a treatment-by-biomarker population interaction term and a 3-way biomarker population-by-treatment-by-visit interaction term was included in the analysis model."||14.26|-8.22|0.5984
72529673|NCT02194699|144589112|SUPERIORITY||LS Mean difference|7.84||||0.3971|TWO_SIDED|95.0|-10.32|26.0|||Repeated measures analysis||Model included fixed categorical effects of baseline PEF (evening), treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as fixed covariate.|"Comparison of mean change from baseline in evening PEF at Week 52: Biomarker positive population; Tralo 300 mg Q2W vs placebo.~REML based repeated measures analysis. A variable for the biomarker population (positive, negative) as well as a treatment-by-biomarker population interaction term and a 3-way biomarker population-by-treatment-by-visit interaction term was included in the analysis model."||26.00|-10.32|0.3971
72571870|NCT02912650|144671807|SUPERIORITY_OR_OTHER||LS Mean Difference|0.48|||<|0.001|TWO_SIDED|95.0|0.2|0.76|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.76|0.20|<0.001
72571871|NCT02912650|144671807|SUPERIORITY_OR_OTHER||LS Mean Difference|0.23||||0.106|TWO_SIDED|95.0|-0.05|0.51|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.51|-0.05|0.106
72571872|NCT02912650|144671807|SUPERIORITY_OR_OTHER||LS Mean Difference|0.25||||0.013|TWO_SIDED|95.0|0.05|0.45|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.45|0.05|0.013
72571873|NCT02912650|144671807|SUPERIORITY_OR_OTHER||LS Mean Difference|0.39||||0.006|TWO_SIDED|95.0|0.11|0.67|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.67|0.11|0.006
72407784|NCT00280566|144323963|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.23|STANDARD_ERROR_OF_MEAN|0.16||0.146|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 16 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.||||0.1460
72529674|NCT02194699|144589112|SUPERIORITY||LS Mean difference|3.59||||0.531|TWO_SIDED|95.0|-7.65|14.83|||Repeated measures analysis||Model included fixed categorical effects of baseline PEF (evening), treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as fixed covariate.|"Comparison of mean change from baseline in evening PEF at Week 52: Biomarker negative population; Tralo 300 mg Q2W vs placebo.~REML based repeated measures analysis. A variable for the biomarker population (positive, negative) as well as a treatment-by-biomarker population interaction term and a 3-way biomarker population-by-treatment-by-visit interaction term was included in the analysis model."||14.83|-7.65|0.5310
72529675|NCT02194699|144589112|SUPERIORITY||LS Mean difference|3.46||||0.4764|TWO_SIDED|95.0|-6.06|12.97|||Repeated measures analysis||Model included fixed categorical effects of baseline PEF (morning), treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as fixed covariate.|Comparison of mean change from baseline in morning PEF at Week 52: FAS population; Tralo 300 mg Q2W vs placebo. REML based repeated measures analysis.||12.97|-6.06|0.4764
72529676|NCT02194699|144589112|SUPERIORITY||LS Mean difference|3.88||||0.4221|TWO_SIDED|95.0|-5.6|13.37|||Repeated measures analysis||Model included fixed categorical effects of baseline PEF (evening), treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as fixed covariate.|Comparison of mean change from baseline in evening PEF at Week 52: FAS population; Tralo 300 mg Q2W vs placebo. REML based repeated measures analysis.||13.37|-5.60|0.4221
72529677|NCT02194699|144589113|SUPERIORITY||LS Mean difference|-5.04||||0.1099|TWO_SIDED|95.0|-11.21|1.14|||Repeated measures analysis||Fixed categorical effects of baseline number (%) of awakenings, treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as a fixed covariate.|"Comparison of mean change from baseline in number (%) of awakenings at Week 52: Biomarker positive population; Tralo 300 mg Q2W vs placebo.~REML based repeated measures analysis. A variable for the biomarker population (positive, negative) as well as a treatment-by-biomarker population interaction term and a 3-way biomarker population-by-treatment-by-visit interaction term was included in the analysis model."||1.14|-11.21|0.1099
72529678|NCT02194699|144589113|SUPERIORITY||LS Mean difference|0.46||||0.8112|TWO_SIDED|95.0|-3.33|4.25|||Repeated measures analysis||Fixed categorical effects of baseline number (%) of awakenings, treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as a fixed covariate.|"Comparison of mean change from baseline in number (%) of awakenings at Week 52: Biomarker positive population; Tralo 300 mg Q2W vs placebo.~REML based repeated measures analysis. A variable for the biomarker population (positive, negative) as well as a treatment-by-biomarker population interaction term and a 3-way biomarker population-by-treatment-by-visit interaction term was included in the analysis model."||4.25|-3.33|0.8112
72529679|NCT02194699|144589113|SUPERIORITY||LS Mean difference|-1.19||||0.4645|TWO_SIDED|95.0|-4.4|2.01|||Repeated measures analysis||Fixed categorical effects of baseline number (%) of awakenings, treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as a fixed covariate.|Comparison of mean change from baseline in number (%) of awakenings at Week 52: FAS population; Tralo 300 mg Q2W vs placebo. REML based repeated measures analysis.||2.01|-4.40|0.4645
72529680|NCT02194699|144589114|SUPERIORITY||Odds Ratio (OR)|0.77||||0.344|TWO_SIDED|95.0|0.44|1.33|||Cochran-Mantel-Haenszel||The estimate of each odds ratio was obtained from a Cochran-Mantel-Haenszel test controlling for geographical region, age group and periostin group at baseline.|Comparison of number of patients with ≥ 1 asthma exacerbations up to Week 52: Biomarker positive population; Tralo 300 mg Q2W vs placebo.||1.33|0.44|0.3440
72529681|NCT02194699|144589114|SUPERIORITY||Odds Ratio (OR)|1.05||||0.7768|TWO_SIDED|95.0|0.75|1.46|||Cochran-Mantel-Haenszel||The estimate of each odds ratio was obtained from a Cochran-Mantel-Haenszel test controlling for geographical region, age group and periostin group at baseline.|Comparison of number of patients with ≥ 1 asthma exacerbations up to Week 52: Biomarker negative population; Tralo 300 mg Q2W vs placebo.||1.46|0.75|0.7768
72529682|NCT02194699|144589114|SUPERIORITY||Odds Ratio (OR)|0.91||||0.5276|TWO_SIDED|95.0|0.69|1.21|||Cochran-Mantel-Haenszel||The estimate of each odds ratio was obtained from a Cochran-Mantel-Haenszel test controlling for geographical region, age group and periostin group at baseline.|Comparison of number of patients with ≥ 1 asthma exacerbations up to Week 52: FAS population; Tralo 300 mg Q2W vs placebo.||1.21|0.69|0.5276
72625599|NCT01968980|144780528|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|259.9|||||TWO_SIDED|95.0|34.87|1937.06||||||Week 52: Odds ratio, associated 95% confidence interval and p-value from a Logistic Regression Model with fixed effects for treatment group,baseline value and geographical region was used for analysis.||1937.06|34.87|
72529683|NCT04853368|144589122|SUPERIORITY||LS Mean of Difference|2.6|STANDARD_ERROR_OF_MEAN|0.84||0.002|TWO_SIDED|90.0|1.22|4.04||One-sided p-value; p-value \<=0.05 indicates significance.|Mixed Models Analysis|Primary analysis of ppFEV1 using MMRM excludes data inconsistent with baseline in terms of the timing of bronchodilator or airway clearance regimen.||||4.04|1.22|0.002
72625600|NCT04537650|144780547|SUPERIORITY||Odds Ratio (OR)|21.0|||<|0.001|TWO_SIDED|95.0|1.8|243.24|||Chi-squared|||||243.24|1.8|<0.001
72625601|NCT04537650|144780548|SUPERIORITY||Odds Ratio (OR)|45.0|||<|0.001|TWO_SIDED|95.0|4.15|487.5|||Chi-squared|||||487.5|4.15|<0.001
72625602|NCT00879398|144780565|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Statistical significant level: 0.05|t-test, 2 sided|||||||<0.0001
72625603|NCT00879398|144780566|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Statistical significant level: 0.05|t-test, 2 sided|||||||<0.0001
72625604|NCT00879398|144780567|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Statistical significant level: 0.05|t-test, 2 sided|||||||<0.0001
72625605|NCT00879398|144780569|SUPERIORITY_OR_OTHER|||||||0.1319||95.0||||Statistical significant level: 0.05|Chi-squared|||Geriatric Status: \<65 years versus (vs) Geriatric Status: ≥65 years||||0.1319
72529684|NCT04853368|144589122|SUPERIORITY||LS Mean of Difference|1.3|STANDARD_ERROR_OF_MEAN|1.92||0.254|TWO_SIDED|90.0|-2.07|4.67||One-sided p-value; p-value \<=0.05 indicates significance.|Mixed Models Analysis|Primary analysis of ppFEV1 using MMRM excludes data inconsistent with baseline in terms of the timing of bronchodilator or airway clearance regimen.||||4.67|-2.07|0.254
72529685|NCT04853368|144589122|SUPERIORITY||LS Mean of Difference|0.9||||0.402|TWO_SIDED|90.0|-5.07|6.77||One-sided p-value; p-value \<=0.05 indicates significance.|Mixed Models Analysis|Primary analysis of ppFEV1 using MMRM excludes data inconsistent with baseline in terms of the timing of bronchodilator or airway clearance regimen.||||6.77|-5.07|0.402
72529686|NCT04853368|144589124|SUPERIORITY||LS Mean of Difference|5.5|STANDARD_ERROR_OF_MEAN|2.63||0.022|TWO_SIDED|90.0|1.07|9.92||One-sided p-value; p-value \<=0.05 indicates significance.|Mixed Models Analysis|The LS mean is estimated using the mixed-Effect model repeat measurement method.||||9.92|1.07|0.022
72529687|NCT04853368|144589124|SUPERIORITY||LS Mean of Difference|-14.1||||0.043|TWO_SIDED|90.0|-27.59|-0.62||One-sided p-value; p-value \<=0.05 indicates significance.|Mixed Models Analysis|The LS mean is estimated using the mixed-Effect model repeat measurement method.||||-0.62|-27.59|0.043
72529688|NCT04853368|144589125|SUPERIORITY||LS Mean of Difference|0.14|STANDARD_ERROR_OF_MEAN|0.047||0.003|TWO_SIDED|90.0|0.059|0.219||One-sided p-value; p-value \<=0.05 indicates significance.|Mixed Models Analysis|The LS mean is estimated using the mixed-Effect model repeat measurement method.||||0.219|0.059|0.003
72529689|NCT04853368|144589125|SUPERIORITY||LS Mean of Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.089||0.475|TWO_SIDED|90.0|-0.162|0.15||One-sided p-value; p-value \<=0.05 indicates significance.|Mixed Models Analysis|The LS mean is estimated using the mixed-Effect model repeat measurement method.||||0.150|-0.162|0.475
72529690|NCT04853368|144589125|SUPERIORITY||LS Mean of Difference|-0.06||||0.352|TWO_SIDED|90.0|-0.332|0.212||One-sided p-value; p-value \<=0.05 indicates significance.|Mixed Models Analysis|The LS mean is estimated using the mixed-Effect model repeat measurement method.||Cohort 2: Difference between Triple Therapy and Placebo||0.212|-0.332|0.352
72529691|NCT04853368|144589126|SUPERIORITY||LS Mean of Difference|0.089|STANDARD_ERROR_OF_MEAN|0.0403||0.017|TWO_SIDED|90.0|0.0209|0.1568||One-sided p-value; p-value \<=0.05 indicates significance.|Mixed Models Analysis|The LS mean is estimated using the mixed-Effect model repeat measurement method.||||0.1568|0.0209|0.017
72529692|NCT04853368|144589126|SUPERIORITY||LS Mean of Difference|0.103|STANDARD_ERROR_OF_MEAN|0.1033||0.169|TWO_SIDED|90.0|-0.1814|0.288||One-sided p-value; p-value \<=0.05 indicates significance.|Mixed Models Analysis|The LS mean is estimated using the mixed-Effect model repeat measurement method.||||0.2880|-0.1814|0.169
72571874|NCT02912650|144671807|SUPERIORITY_OR_OTHER||LS Mean Difference|0.03||||0.796|TWO_SIDED|95.0|-0.17|0.22|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.22|-0.17|0.796
72529693|NCT04853368|144589126|SUPERIORITY||Mean Difference (Final Values)|0.136||||0.23|TWO_SIDED|90.0|-0.1809|0.4527||One-sided p-value; p-value \<=0.05 indicates significance.|Mixed Models Analysis|The LS mean is estimated using the mixed-Effect model repeat measurement method.||||0.4527|-0.1809|0.230
72529694|NCT04853368|144589127|SUPERIORITY||LS Mean of Difference|4.4||||0.002|TWO_SIDED|90.0|2.04|6.78||One-sided p-value; p-value \<=0.05 indicates significance.|Mixed Models Analysis|||||6.78|2.04|0.002
72529695|NCT04853368|144589127|SUPERIORITY||LS Mean of Difference|1.3||||0.35|TWO_SIDED|90.0|-4.42|6.97||One-sided p-value; p-value \<=0.05 indicates significance.|Mixed Models Analysis|||||6.97|-4.42|0.350
72529696|NCT04853368|144589127|SUPERIORITY||LS Mean of Difference|1.3||||0.412|TWO_SIDED|90.0|-8.75|11.34||One-sided p-value; p-value \<=0.05 indicates significance.|Mixed Models Analysis|||||11.34|-8.75|0.412
72529697|NCT04853368|144589128|SUPERIORITY||LS Mean of Difference|4.36|||<|0.001|TWO_SIDED|90.0|2.19|6.524||One-sided p-value; p-value \<=0.05 indicates significance.|Mixed Models Analysis|||||6.524|2.190|<0.001
72529698|NCT04853368|144589128|SUPERIORITY||LS Mean of Difference|-0.59||||0.396|TWO_SIDED|90.0|-4.449|3.268||One-sided p-value; p-value \<=0.05 indicates significance.|Mixed Models Analysis|||||3.268|-4.449|0.396
72529699|NCT04853368|144589128|SUPERIORITY||LS Mean of Difference|-2.0||||0.305|TWO_SIDED|90.0|-8.724|4.732||One-sided p-value; p-value \<=0.05 indicates significance.|Mixed Models Analysis|||||4.732|-8.724|0.305
72529700|NCT04853368|144589129|SUPERIORITY||LS Mean of Difference|6.475||||0.018|TWO_SIDED|90.0|1.4443|11.5056||One-sided p-value; p-value \<=0.05 indicates significance.|Mixed Models Analysis|||||11.5056|1.4443|0.018
72529701|NCT04853368|144589129|SUPERIORITY||LS Mean of Difference|6.019||||0.214|TWO_SIDED|90.0|-7.1464|19.1844||One-sided p-value; p-value \<=0.05 indicates significance.|Mixed Models Analysis|||||19.1844|-7.1464|0.214
72571875|NCT02912650|144671807|SUPERIORITY_OR_OTHER||LS Mean Difference|0.16||||0.104|TWO_SIDED|95.0|-0.03|0.36|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.36|-0.03|0.104
72625606|NCT00879398|144780569|SUPERIORITY_OR_OTHER|||||||0.601||95.0||||Statistical significant level: 0.05|Chi-squared|||Comparison among Age Categories: \<50 years, 50 to 59 years, 60 to 69 years, 70 to 79 years, and ≥80 years.||||0.6010
72529702|NCT04853368|144589129|SUPERIORITY||LS Mean of Difference|7.29||||0.286|TWO_SIDED|90.0|-15.186|29.766||One-sided p-value; p-value \<=0.05 indicates significance.|Mixed Models Analysis|||||29.7660|-15.1860|0.286
72529703|NCT04853368|144589130|SUPERIORITY||LS Mean of Difference|5.6||||0.057|TWO_SIDED|90.0|-0.26|11.37||One-sided p-value; p-value \<=0.05 indicates significance.|Mixed Models Analysis|||||11.37|-0.26|0.057
72529704|NCT04853368|144589130|SUPERIORITY||LS Mean of Difference|8.6||||0.088|TWO_SIDED|90.0|-2.18|19.4||One-sided p-value; p-value \<=0.05 indicates significance.|Mixed Models Analysis|||||19.40|-2.18|0.088
72529705|NCT04853368|144589130|SUPERIORITY||LS Mean of Difference|11.2||||0.142|TWO_SIDED|90.0|-6.9|29.25||One-sided p-value; p-value \<=0.05 indicates significance.|Mixed Models Analysis|Note: The LS mean is estimated using the linear regression on the change in CFQ-R from baseline to day 29.||||29.25|-6.90|0.142
72571876|NCT02912650|144671807|SUPERIORITY_OR_OTHER||LS Mean Difference|0.37||||0.01|TWO_SIDED|95.0|0.09|0.65|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.65|0.09|0.010
72571877|NCT02912650|144671807|SUPERIORITY_OR_OTHER||LS Mean Difference|0.23||||0.114|TWO_SIDED|95.0|-0.05|0.51|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.51|-0.05|0.114
72625607|NCT00879398|144780569|SUPERIORITY_OR_OTHER|||||||0.0289||95.0||||Statistical significant level: 0.05|Chi-squared|||Male vs Female||||0.0289
72407785|NCT00280566|144323963|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.15||0.7301|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 20 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.||||0.7301
72407786|NCT00280566|144323963|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.03|STANDARD_ERROR_OF_MEAN|0.14||0.8162|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 24 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.||||0.8162
72407787|NCT00280566|144323964|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.48|STANDARD_ERROR_OF_MEAN|0.15||0.0013|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 1 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.||||0.0013
72529706|NCT04495166|144589136|SUPERIORITY|||||||0.757||||||Statistical tests were 2-sided and p values \<0.05 were considered statistically significant|t-test, 2 sided|To include participants that were not assessed in post-baseline assessments we used multiple imputation by chained equations with 100 imputations.||The sample size was calculated based on an effect size of 0.65 on depression, which is based on a previous meta-analysis (Sockol et al., 2011). Sample size calculation considered a difference in means between two independent groups, probability of type I error of 5%, statistical power of 80%, a two-tailed test, and a dropout rate of 15%.||||0.757
72529707|NCT04495166|144589137|SUPERIORITY|||||||0.91||||||Statistical tests were 2-sided and p values \<0.05 were considered statistically significant|t-test, 2 sided|To include participants that were not assessed in post-baseline assessments we used multiple imputation by chained equations with 100 imputations.||||||0.910
72529708|NCT04495166|144589139|SUPERIORITY|||||||0.442||||||Statistical tests were 2-sided and p values \<0.05 were considered statistically significant|t-test, 2 sided|To include participants that were not assessed in post-baseline assessments we used multiple imputation by chained equations with 100 imputations.||||||0.442
72529709|NCT04495166|144589140|SUPERIORITY|||||||0.223||||||Statistical tests were 2-sided and p values \<0.05 were considered statistically significant|t-test, 2 sided|To include participants that were not assessed in post-baseline assessments we used multiple imputation by chained equations with 100 imputations.||||||0.223
72529710|NCT04495166|144589141|SUPERIORITY|||||||0.54||||||Statistical tests were 2-sided and p values \<0.05 were considered statistically significant|t-test, 2 sided|To include participants that were not assessed in post-baseline assessments we used multiple imputation by chained equations with 100 imputations.||||||0.540
72529711|NCT04495166|144589142|SUPERIORITY|||||||0.901||||||Statistical tests were 2-sided and p values \<0.05 were considered statistically significant|t-test, 2 sided|To include participants that were not assessed in post-baseline assessments we used multiple imputation by chained equations with 100 imputations.||||||0.901
72529712|NCT04495166|144589143|SUPERIORITY|||||||0.748||||||Statistical tests were 2-sided and p values \<0.05 were considered statistically significant|t-test, 2 sided|To include participants that were not assessed in post-baseline assessments we used multiple imputation by chained equations with 100 imputations.||||||0.748
72571878|NCT02912650|144671807|SUPERIORITY_OR_OTHER||LS Mean Difference|0.14||||0.168|TWO_SIDED|95.0|-0.06|0.34|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.34|-0.06|0.168
72529713|NCT02127970|144589153|NON_INFERIORITY|The non-inferiority hypothesis test was to be a one-sided hypothesis test performed at the 2.5% level of significance. If the lower limit of the 95% CI for the difference in responder rates is greater than -10%, then the single-dose dalbavancin regimen was to be declared non-inferior to the two dose dalbavancin regimen.|Difference|-2.9|||||TWO_SIDED|95.0|-8.5|2.8|||||For the difference in clinical responder rates (single-dose group minus two dose group), the 95% CI was calculated using the Miettinen and Nurminen method without adjustment.|||2.8|-8.5|
72529714|NCT00542321|144589172|SUPERIORITY_OR_OTHER||difference between proportions|0.5||||1|TWO_SIDED|95.0|||||Fisher Exact|Chi-Square = 0.750, df = 1||Pearson Chi-Square Test for difference between groups||||1.00
72529715|NCT00542321|144589173|SUPERIORITY_OR_OTHER||Rank sums|52.0||||1|TWO_SIDED|95.0||||Alpha = .05|Wilcoxon (Mann-Whitney)|||There will be no difference in duration of mechanical ventilation between groups.||||1.0
72529716|NCT00542321|144589174|SUPERIORITY_OR_OTHER|||||||0.451||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.451
72529717|NCT00542321|144589175|SUPERIORITY_OR_OTHER||probability|0.43||||1||95.0|||||Fisher Exact|||||||1.0
72529718|NCT00542321|144589176|SUPERIORITY_OR_OTHER||Rank sums|56.0||||1|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||1.0
72571879|NCT02912650|144671807|SUPERIORITY_OR_OTHER||LS Mean Difference|0.32||||0.022|TWO_SIDED|95.0|0.05|0.59|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.59|0.05|0.022
72625608|NCT00879398|144780569|SUPERIORITY_OR_OTHER|||||||0.3078||95.0||||Statistical significant level: 0.05|Chi-squared|||Comparison among Weight Categories: \<50 kg, 50 to 60 kg, 60 to 70 kg, and ≥70 kg.||||0.3078
72529719|NCT03287089|144589181|SUPERIORITY||Odds Ratio (OR)|1.09||||0.84|TWO_SIDED|95.0|0.49|2.43|||Chi-squared|||||2.43|0.49|0.84
72529720|NCT03287089|144589182|SUPERIORITY|||||||0.44|||||||Chi-squared|||||||0.44
72529721|NCT03287089|144589183|SUPERIORITY|||||||0.68|||||||t-test, 1 sided|||||||0.68
72529722|NCT00661362|144589184|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.42|STANDARD_ERROR_OF_MEAN|0.067|<|0.0001|TWO_SIDED|95.0|-0.55|-0.29|||ANCOVA|||||-0.29|-0.55|<0.0001
72529723|NCT00661362|144589185|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.56|STANDARD_ERROR_OF_MEAN|0.149|<|0.0002|TWO_SIDED|95.0|-0.85|-0.26|||ANCOVA|||||-0.26|-0.85|<0.0002
72571880|NCT02912650|144671807|SUPERIORITY_OR_OTHER||LS Mean Difference|0.05||||0.62|TWO_SIDED|95.0|-0.14|0.24|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.24|-0.14|0.620
72625609|NCT00879398|144780569|SUPERIORITY_OR_OTHER|||||||0.9614||95.0||||Statistical significant level: 0.05|Chi-squared|||Comparison among Height Categories: \<160 cm, 160 to 170 cm, and ≥170 cm.||||0.9614
72625610|NCT00879398|144780569|SUPERIORITY_OR_OTHER|||||||0.0788||95.0||||Statistical significant level: 0.05|Fisher Exact|||Allergic History: Yes vs Allergic History: No||||0.0788
72407788|NCT00280566|144323964|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.27|STANDARD_ERROR_OF_MEAN|0.17||0.1167|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 2 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.||||0.1167
72529724|NCT00661362|144589186|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-10.1|STANDARD_ERROR_OF_MEAN|2.684|<|0.0002|TWO_SIDED|95.0|-15.37|-4.83|||ANCOVA|||||-4.83|-15.37|<0.0002
72529725|NCT00661362|144589187|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-155.0|STANDARD_ERROR_OF_MEAN|55.0||0.0052|TWO_SIDED|95.0|-264.0|-47.0|||ANCOVA|||||-47|-264|0.0052
72529726|NCT00661362|144589188|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2802.0|STANDARD_ERROR_OF_MEAN|989.8||0.0052|TWO_SIDED|95.0|-4753.0|-852.0|||ANCOVA|||||-852|-4753|0.0052
72529727|NCT00661362|144589189|SUPERIORITY_OR_OTHER||Mean Difference (Net)|16.1|||<|0.0001|TWO_SIDED|95.0|8.0|24.0|||ANCOVA|||||24.0|8.0|<0.0001
72529728|NCT04880642|144589200|SUPERIORITY|"The null hypothesis was that the there was no difference in survival up to Day 60 between the two groups and was to be rejected in favour of the alternative hypothesis i.e. a difference in survival up to Day 60 between the two groups excisted.~The overall 2-sided significance level of 5% was applied to the primary endpoint."|Hazard Ratio (HR)|0.98||||0.949|TWO_SIDED|95.0|0.4|2.36|||Log Rank|||||2.36|0.40|0.949
72529729|NCT04880642|144589201|SUPERIORITY||Hazard Ratio (HR)|1.18||||0.301|TWO_SIDED|95.0|0.91|1.52|||Log Rank|||||1.52|0.91|0.301
72529730|NCT04880642|144589202|SUPERIORITY||Median Difference (Final Values)|0.0||||0.425|TWO_SIDED|95.0|-1.0|1.0|||Wilcoxon (Mann-Whitney)|||||1|-1|0.425
72529731|NCT04880642|144589203|SUPERIORITY||Risk Difference (RD)|-1.7|STANDARD_ERROR_OF_MEAN|3.91||0.671|TWO_SIDED|95.0|-9.3|6.0|||Regression, Logistic|||||6.0|-9.3|0.671
72529732|NCT04880642|144589204|SUPERIORITY||Risk Difference (RD)|-0.4|STANDARD_ERROR_OF_MEAN|5.62||0.948|TWO_SIDED|95.0|-11.4|10.6|||Regression, Logistic|||||10.6|-11.4|0.948
72407789|NCT00280566|144323964|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.17||0.0188|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 4 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.||||0.0188
72529733|NCT00104299|144589205|NON_INFERIORITY_OR_EQUIVALENCE|non-inferiority margin of -20%|Difference between group success rates|10.6|||<|0.001||95.1|-3.2|24.3||P-value is adjusted for interim analysis using a Lan-DeMets alpha spending function with an O'Brien-Fleming boundary, allocating 0.003 alpha to the interim analysis and 0.049 alpha to the final analysis.|95.1% CI of difference|Calculate 95.1% CI around the difference in success rates between arms. Lower bound above non-inferiority margin of -20% indicates non-inferiority.||In calculating the sample size, we assumed that the percentage of patients in both treatment groups would achieve disease remission off prednisone by 6 months was 70%. We specified a non-inferiority margin of -20% on the difference in remission rates (rituximab rate minus cyclophosphamide rate) and a one-sided 0.025 level test. Assuming a 10% dropout rate, RAVE required 100 patients in each arm to have 83% power to conclude non-inferiority.||24.3|-3.2|<0.001
72529734|NCT00104299|144589206|SUPERIORITY_OR_OTHER|||||||0.927||||||P-value is from the Poisson regression model adjusting for clinical study site and ANCA type. The natural logarithm of participant-months is used as an offset in this model|Poisson regression model|||Participant-months are defined as duration in months from the first study drug dosing date to the last date of the participant in the protocol. The rate of selected AEs is defined as the total number of selected AEs divided by total participant-months, and indicates the number of events per participant per month on average. Participants are grouped according to their originally received treatment.||||0.927
72529735|NCT00104299|144589207|SUPERIORITY_OR_OTHER||95.1% Confidence Interval of Difference|10.6||||0.133|TWO_SIDED|95.1|-3.2|24.4|||Chi-squared|At 6 months, the confidence interval is 95.1%.||The p-value is from a chi-square test.||24.4|-3.2|0.133
72529736|NCT00104299|144589208|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.9||||0.761|TWO_SIDED|95.0|0.5|1.7||The log-rank test assesses the difference between the two treatment arms in the flaring pattern after complete remission|Log Rank|The log-rank test assesses the difference between the two treatment arms in the flaring pattern after complete remission||Participants are censored at the time of crossover, open label rituximab, or best medical judgement, if applicable. If a participant has no flare after complete remission prior to their Month 18 visit, the duration is censored at the date of the Month 18 Visit||1.7|0.5|0.761
72529737|NCT00104299|144589209|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.9||||0.861|TWO_SIDED|95.0|0.6|1.5|||Log Rank|The log-rank test assesses the difference between the two treatment arms in the flaring pattern after remission||Participants are censored at the time of crossover, open label rituximab, or best medical judgement, if applicable. If a participant has no flare after complete remission prior to their Month 18 visit, the duration is censored at the date of the Month 18 Visit||1.5|0.6|0.861
72529738|NCT00104299|144589210|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.0||||0.497|TWO_SIDED|95.0|0.7|1.3|||Log Rank|The log-rank test assesses the difference between the two treatment arms in the pattern of achieving remission|The hazard ratio and confidence interval are based on a Cox proportional hazard model comparing rituximab to the control group, adjusting for clinical study site, ANCA type, and glucocorticoid use prior to baseline.|||1.3|0.7|0.497
72529739|NCT00104299|144589211|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.3||||0.147|TWO_SIDED|95.0|0.9|1.8|||Log Rank|The log-rank test assesses the difference between the two treatment arms in the pattern of achieving complete remission|The hazard ratio and confidence interval are based on a Cox proportional hazard model comparing rituximab to the control group, adjusting for clinical study site, ANCA type, and glucocorticoid use prior to baseline.|||1.8|0.9|0.147
72625611|NCT00879398|144780569|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Statistical significant level: 0.05|Chi-squared|||Comparison among Duration of Disease: \<1 week, 1 to 8 weeks, 8 to 16 weeks, and ≥16 weeks.||||<0.0001
72625612|NCT00879398|144780569|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Statistical significant level: 0.05|Chi-squared|||Past OAB Treatment History: Yes vs Past OAB Treatment History: No||||<0.0001
72529740|NCT00104299|144589212|SUPERIORITY_OR_OTHER|||||||0.504||95.0|||||Chi-squared|||Proportions of subjects experiencing a serious adverse event through 18 months and prior to censoring for open-label, crossover, or best medical judgment according to originally assigned treatment arm were compared using a two-sided Chi-squared test.||||0.504
72529741|NCT00608426|144589249|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED||||||Regression, Logistic|||||||.02
72529742|NCT00608426|144589250|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||for the comparison of telephone counseling between the two groups|Mixed effects logistic regression|||||||<.001
72529743|NCT00608426|144589250|SUPERIORITY_OR_OTHER|||||||0.57|TWO_SIDED|||||for the comparison of in-person counseling between the two groups|Mixed effects logistic regression|||||||0.57
72529744|NCT00608426|144589250|SUPERIORITY_OR_OTHER|||||||0.15|TWO_SIDED|||||for the comparison of used medications between the two groups|Mixed effects logistic regression|||||||.15
72529745|NCT00608426|144589250|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||for the comparison of combination counseling and medication between the two groups|Mixed effects logistic regression|||||||<.001
72529746|NCT00608426|144589250|SUPERIORITY_OR_OTHER|||||||0.77|TWO_SIDED|||||for the comparison of attended VA smoking cessation clinic between the two groups|Mixed effects logistic regression|||||||.77
72529747|NCT00608426|144589250|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED|||||for the comparison of received VA smoking cessation medication between the two groups|Mixed effects logistic regression|||||||.002
72529748|NCT00608426|144589251|SUPERIORITY_OR_OTHER|||||||0.13|TWO_SIDED||||||Regression, Logistic|||||||0.13
72529749|NCT02630459|144589265|SUPERIORITY|To maintain a family-wise type I error at 0.05, the pairwise comparisons were tested in a sequential testing procedure in the order of erenumab 140 mg QM vs placebo, erenumab 70 mg QM vs placebo and erenumab 28 mg QM vs placebo. The lower dose group was tested only when the higher dose group was considered statistically significant.|LS Mean Difference|-1.89|||<|0.001|TWO_SIDED|95.0|-2.58|-1.2||P-values for pairwise comparisons were nominal and without multiplicity adjustment.|Generalized Linear Mixed Model|||The primary analysis utilized a generalized linear mixed model which included treatment, visit, treatment by visit interaction, stratification factor (prior/current treatment with migraine prophylactic medication status), and baseline value as covariates and assumed a first-order autoregressive covariance structure||-1.20|-2.58|<0.001
72529750|NCT02630459|144589265|SUPERIORITY|To maintain a family-wise type I error at 0.05, the pairwise comparisons were tested in a sequential testing procedure in the order of erenumab 140 mg QM vs placebo, erenumab 70 mg QM vs placebo and erenumab 28 mg QM vs placebo. The lower dose group was tested only when the higher dose group was considered statistically significant.|LS Mean Difference|-2.31|||<|0.001|TWO_SIDED|95.0|-3.0|-1.62||P-values for pairwise comparisons were nominal and without multiplicity adjustment.|Generalized Linear Mixed Model|||The primary analysis utilized a generalized linear mixed model which included treatment, visit, treatment by visit interaction, stratification factor (prior/current treatment with migraine prophylactic medication status), and baseline value as covariates and assumed a first-order autoregressive covariance structure||-1.62|-3.00|<0.001
72529751|NCT02630459|144589265|SUPERIORITY|To maintain a family-wise type I error at 0.05, the pairwise comparisons were tested in a sequential testing procedure in the order of erenumab 140 mg QM vs placebo, erenumab 70 mg QM vs placebo and erenumab 28 mg QM vs placebo. The lower dose group was tested only when the higher dose group was considered statistically significant.|LS Mean Difference|-1.25||||0.004|TWO_SIDED|95.0|-2.1|-0.41||P-values for pairwise comparisons were nominal and without multiplicity adjustment.|Generalized Linear Mixed Model|||The primary analysis utilized a generalized linear mixed model which included treatment, visit, treatment by visit interaction, stratification factor (prior/current treatment with migraine prophylactic medication status), and baseline value as covariates and assumed a first-order autoregressive covariance structure||-0.41|-2.10|0.004
72529752|NCT02630459|144589266|SUPERIORITY||Treatment Difference|0.0|||||TWO_SIDED|95.0|-13.3|13.8|||||The 95% CI for the difference was calculated using the Newcombe hybrid score method.|Week 4: Full Administration||13.8|-13.3|
72529753|NCT02630459|144589266|SUPERIORITY||Treatment Difference|0.0|||||TWO_SIDED|95.0|-13.8|13.3|||||The 95% CI for the difference was calculated using the Newcombe hybrid score method.|Week 4: Not Full Administration||13.3|-13.8|
72529754|NCT02630459|144589266|SUPERIORITY||Treatment Difference|0.0|||||TWO_SIDED|95.0|-13.8|13.3|||||The 95% CI for the difference was calculated using the Newcombe hybrid score method.|Week 4: Discontinued Investigational Product||13.3|-13.8|
72529755|NCT02630459|144589266|SUPERIORITY||Treatment Difference|0.0|||||TWO_SIDED|95.0|-13.3|13.8|||||The 95% CI for the difference was calculated using the Newcombe hybrid score method.|Week 8: Full Administration||13.8|-13.3|
72529756|NCT02630459|144589266|SUPERIORITY||Treatment Difference|0.0|||||TWO_SIDED|95.0|-13.8|13.3|||||The 95% CI for the difference was calculated using the Newcombe hybrid score method.|Week 8: Not Full Administration||13.3|-13.8|
72529757|NCT02630459|144589266|SUPERIORITY||Treatment Difference|0.0|||||TWO_SIDED|95.0|-13.8|13.3|||||The 95% CI for the difference was calculated using the Newcombe hybrid score method.|Week 8: Discontinued Investigational Product||13.3|-13.8|
72529758|NCT02630459|144589267|SUPERIORITY||Common Odds Ratio|4.73|||<|0.001|TWO_SIDED|95.0|2.24|9.99||P-values for pairwise comparisons were nominal and obtained from the CMH test using data including placebo and corresponding erenumab dose group only.|Cochran-Mantel-Haenszel|||The common odds ratios and p-values were obtained from a Cochran-Mantel-Haenszel (CMH) test, stratified by stratification factor prior/current treatment with migraine prophylactic medication status.||9.99|2.24|<0.001
72529759|NCT02630459|144589267|SUPERIORITY||Common Odds Ratio|5.6|||<|0.001|TWO_SIDED|95.0|2.6|12.06||P-values for pairwise comparisons were nominal and obtained from the CMH test using data including placebo and corresponding erenumab dose group only.|Cochran-Mantel-Haenszel|||The common odds ratios and p-values were obtained from a CMH test, stratified by stratification factor prior/current treatment with migraine prophylactic medication status.||12.06|2.60|<0.001
72529760|NCT02630459|144589267|SUPERIORITY||Common Odds Ratio|3.21||||0.009|TWO_SIDED|95.0|1.3|7.88||P-values for pairwise comparisons were nominal and obtained from the CMH test using data including placebo and corresponding erenumab dose group only.|Cochran-Mantel-Haenszel|||The common odds ratios and p-values were obtained from a CMH test, stratified by stratification factor prior/current treatment with migraine prophylactic medication status.||7.88|1.30|0.009
72571881|NCT02912650|144671807|SUPERIORITY_OR_OTHER||LS Mean Difference|0.14||||0.164|TWO_SIDED|95.0|-0.06|0.33|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.33|-0.06|0.164
72407790|NCT00280566|144323964|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.15|STANDARD_ERROR_OF_MEAN|0.16||0.3413|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 8 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.||||0.3413
72407791|NCT00280566|144323964|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.18|STANDARD_ERROR_OF_MEAN|0.16||0.276|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 12 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.||||0.2760
72407792|NCT00280566|144323964|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.51|STANDARD_ERROR_OF_MEAN|0.19||0.0085|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 16 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.||||0.0085
72407793|NCT00280566|144323964|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.27|STANDARD_ERROR_OF_MEAN|0.18||0.1317|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 20 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.||||0.1317
72407794|NCT00280566|144323964|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.25|STANDARD_ERROR_OF_MEAN|0.18||0.1666|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 24 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.||||0.1666
72407795|NCT00280566|144323965|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.29|STANDARD_ERROR_OF_MEAN|0.75||0.0023|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 1 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.||||0.0023
72407796|NCT00280566|144323965|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.34|STANDARD_ERROR_OF_MEAN|0.91||0.1412|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 2 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate||||0.1412
72407797|NCT00280566|144323965|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.49|STANDARD_ERROR_OF_MEAN|0.87||0.0861|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 4 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.||||0.0861
72407798|NCT00280566|144323965|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.43|STANDARD_ERROR_OF_MEAN|0.82||0.5992|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 8 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.||||0.5992
72407799|NCT00280566|144323965|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.41|STANDARD_ERROR_OF_MEAN|0.76||0.5873|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 12 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.||||0.5873
72529761|NCT02630459|144589268|SUPERIORITY|To maintain a family-wise type I error at 0.05, the pairwise comparisons were tested in a sequential testing procedure in the order of erenumab 140 mg QM vs placebo, erenumab 70 mg QM vs placebo and erenumab 28 mg QM vs placebo. The lower dose group was tested only when the higher dose group was considered statistically significant.|LS Mean Difference|-2.04|||<|0.001|TWO_SIDED|95.0|-2.63|-1.45||P-values for pairwise comparisons were nominal and without multiplicity adjustment.|Generalized Linear Mixed Model|||The primary analysis utilized a generalized linear mixed model which included treatment, visit, treatment by visit interaction, stratification factor (prior/current treatment with migraine prophylactic medication status), and baseline value as covariates and assumed a first-order autoregressive covariance structure||-1.45|-2.63|<0.001
72407800|NCT00280566|144323965|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.97|STANDARD_ERROR_OF_MEAN|0.78||0.2116|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 16 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.||||0.2116
72407801|NCT00280566|144323965|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.9|STANDARD_ERROR_OF_MEAN|0.68||0.1847|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 20 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.||||0.1847
72542616|NCT01042977|144615154|SUPERIORITY_OR_OTHER||Risk Difference (RD)|13.6|STANDARD_ERROR_OF_MEAN|2.149|<|0.0001|TWO_SIDED|95.0|9.4|17.8||Significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure|Regression, Logistic|Based on methodology of Zhang, Tsiatis \& Davidian and Davidian, Tsiatis, Zhang \& Lu, with adjustment for baseline total body weight and age stratum||H0: proportion(treat) minus proportion(placebo) = 0 versus the alternative HA: proportion(treat) minus proportion(placebo) =/= 0||17.8|9.4|<0.0001
72407802|NCT00280566|144323965|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.82||0.9972|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 24 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.||||0.9972
72407803|NCT00280566|144323966|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.49|STANDARD_ERROR_OF_MEAN|0.93||0.5954|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 4 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.||||0.5954
72407804|NCT00280566|144323966|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.89|STANDARD_ERROR_OF_MEAN|0.93||0.3414|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 8 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.||||0.3414
72407805|NCT00280566|144323966|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.04|STANDARD_ERROR_OF_MEAN|1.23||0.9745|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 12 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate||||0.9745
72407806|NCT00280566|144323966|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.85|STANDARD_ERROR_OF_MEAN|1.47||0.5627|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 16 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.||||0.5627
72407807|NCT00280566|144323966|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.36|STANDARD_ERROR_OF_MEAN|1.1||0.741|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 20 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.||||0.7410
72407808|NCT00280566|144323966|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.04|STANDARD_ERROR_OF_MEAN|0.88||0.9632|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 24 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.||||0.9632
72407809|NCT00280566|144323967|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.22||0.9538|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 4 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.||||0.9538
72407810|NCT00280566|144323967|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.25||0.8541|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 8 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.||||0.8541
72407811|NCT00280566|144323967|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.52|STANDARD_ERROR_OF_MEAN|0.32||0.1084|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 12 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.||||0.1084
72407812|NCT00280566|144323967|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.56|STANDARD_ERROR_OF_MEAN|0.27||0.038|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 16 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.||||0.0380
72407813|NCT00280566|144323967|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.39|STANDARD_ERROR_OF_MEAN|0.35||0.2649|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 20 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.||||0.2649
72407814|NCT00280566|144323967|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.32|STANDARD_ERROR_OF_MEAN|0.27||0.2394|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 24 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.||||0.2394
72407815|NCT00280566|144323968|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.07|STANDARD_ERROR_OF_MEAN|0.29||0.8117|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 4 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.||||0.8117
72407816|NCT00280566|144323968|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.51|STANDARD_ERROR_OF_MEAN|0.26||0.0443|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 8 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.||||0.0443
72407817|NCT00280566|144323968|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.29|STANDARD_ERROR_OF_MEAN|0.28||0.3039|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 12 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.||||0.3039
72407818|NCT00280566|144323968|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0|STANDARD_DEVIATION|0.46||0.9953|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 16 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.||||0.9953
72407819|NCT00280566|144323968|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.44|STANDARD_ERROR_OF_MEAN|0.32||0.1653|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 20 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.||||0.1653
72407820|NCT00280566|144323968|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.18|STANDARD_ERROR_OF_MEAN|0.32||0.5771|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 24 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.||||0.5771
72529762|NCT02630459|144589268|SUPERIORITY|To maintain a family-wise type I error at 0.05, the pairwise comparisons were tested in a sequential testing procedure in the order of erenumab 140 mg QM vs placebo, erenumab 70 mg QM vs placebo and erenumab 28 mg QM vs placebo. The lower dose group was tested only when the higher dose group was considered statistically significant.|LS Mean Difference|-2.07|||<|0.001|TWO_SIDED|95.0|-2.66|-1.49||P-values for pairwise comparisons were nominal and without multiplicity adjustment.|Generalized Linear Mixed Model|||The primary analysis utilized a generalized linear mixed model which included treatment, visit, treatment by visit interaction, stratification factor (prior/current treatment with migraine prophylactic medication status), and baseline value as covariates and assumed a first-order autoregressive covariance structure||-1.49|-2.66|<0.001
72529763|NCT02630459|144589268|SUPERIORITY|To maintain a family-wise type I error at 0.05, the pairwise comparisons were tested in a sequential testing procedure in the order of erenumab 140 mg QM vs placebo, erenumab 70 mg QM vs placebo and erenumab 28 mg QM vs placebo. The lower dose group was tested only when the higher dose group was considered statistically significant.|LS Mean Difference|-1.07||||0.004|TWO_SIDED|95.0|-1.8|-0.35||P-values for pairwise comparisons were nominal and without multiplicity adjustment.|Generalized Linear Mixed Model|||The primary analysis utilized a generalized linear mixed model which included treatment, visit, treatment by visit interaction, stratification factor (prior/current treatment with migraine prophylactic medication status), and baseline value as covariates and assumed a first-order autoregressive covariance structure||-0.35|-1.80|0.004
72529764|NCT01453439|144589277|SUPERIORITY||Slope|-0.4602|STANDARD_ERROR_OF_MEAN|0.1249|<|0.01|TWO_SIDED|||||Degrees of freedom=90.9|Mixed Models Analysis|Effect of interest: time by group interaction|The estimated value describes the mean slope difference of CBT compared to SPT.|"We compared the difference in the rate of change in BDD symptom severity over time (during treatment phase) between the randomized treatment groups (CBT vs. SPT) using a latent growth curve model that included terms for treatment group, time, site, and all their interactions, modeling intercepts and slopes as random effects per person.~Null hypothesis: The rate of change in BDD symptom severity in the CBT group will not be significantly different from the SPT group \[to be tested\]."||||<.01
72529765|NCT01453439|144589277|SUPERIORITY||Slope|-0.00984|STANDARD_ERROR_OF_MEAN|0.1038||0.62|TWO_SIDED|||||Degrees of freedom=74.7|Mixed Models Analysis|The effect of interest was the time by group interaction.|The estimated value describes the mean slope difference of CBT compared to SPT during follow-up (week 24 to week 50).|"We compared the difference in the rate of change in BDD symptom severity over time (during the follow-up phase) between the randomized treatment groups (CBT vs. SPT) using a latent growth curve model that included terms for treatment group, time, site, and all their interactions, modeling intercepts and slopes as random effects per person.~Null hypothesis: The rate of change in BDD symptom severity during follow-up will not differ significantly between CBT and SPT treatments \[to be tested\]."||||.62
72529766|NCT01453439|144589278|SUPERIORITY|||||||0.1||||||Degrees of freedom=93.2|Mixed Models Analysis|||"We compared the change in Patient Insight over time (During Treatment phase) by randomized treatment group (CBT vs. SPT) using a latent growth curve model that included terms for treatment group, time, site, and all their interactions, modeling intercepts and slopes as random effects per person.~Null hypothesis: The rate of improvement in insight in the CBT group will not be significantly different from the SPT group \[to be tested\]."||||.10
72625613|NCT00879398|144780569|SUPERIORITY_OR_OTHER|||||||0.1147||95.0||||Statistical significant level: 0.05|Chi-squared|||Medical History of Past Disease: Yes vs Medical History of Past Disease: No||||0.1147
72529767|NCT01453439|144589278|SUPERIORITY|||||||0.45||||||Degrees of freedom=74.5|Mixed Models Analysis|||"We compared the change in Patient Insight over time (during the follow-up phase), by randomized treatment group (CBT vs. SPT) using a latent growth curve model that included terms for treatment group, time, site, and all their interactions, modeling intercepts and slopes as random effects per person.~Null hypothesis: The rate of improvement in insight in the CBT group will not be significantly different from the SPT group during follow-up \[to be tested\]."||||.45
72625614|NCT00879398|144780569|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Statistical significant level: 0.05|Chi-squared|||Medical History of Present Disease: Yes vs Medical History of Present Disease: No||||<0.0001
72625615|NCT00879398|144780569|SUPERIORITY_OR_OTHER|||||||1||95.0||||Statistical significant level: 0.05|Fisher Exact|||Kidney Disorder: Yes vs Kidney Disorder: No||||1.0000
72625616|NCT00879398|144780569|SUPERIORITY_OR_OTHER|||||||1||95.0||||Statistical significant level: 0.05|Fisher Exact|||Liver Disorder: Yes vs Liver Disorder: No||||1.0000
72625617|NCT00879398|144780569|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Statistical significant level: 0.05|Chi-squared|||Comparison among Total Administration Period of Toviaz Subgroups: \<2 months, 2 to 4 months, and ≥4 months.||||<0.0001
72407821|NCT01109316|144323973|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin of 0.6 mmol/L was used.|Least Squares Mean Difference|0.48|||||TWO_SIDED|95.0|0.2|0.76|||||Least Squares Mean Difference = Insulin Lispro 6 Day minus Insulin Aspart 6 Day; adjusted for Treatment + Sequence + Period + Age stratum + Baseline HbA1c.|This was the primary gated analysis.||0.76|0.20|
72407822|NCT01109316|144323974|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin of 0.6 mmol/L was used.|Least Squares Mean Difference|0.22|||||TWO_SIDED|95.0|-0.07|0.52|||||Least Squares Mean Difference = Insulin Lispro 6 Day minus Insulin Aspart 6 Day; adjusted for Treatment + Sequence + Period + Age Stratum + Baseline HbA1c; where participant is treated as a random effect.|||0.52|-0.07|
72407823|NCT01109316|144323974|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin of 0.6 mmol/L was used.|Least Squares Mean Difference|0.25|||||TWO_SIDED|95.0|-0.05|0.56|||||Least Squares Mean Difference = Insulin Lispro 6 Day minus Insulin Aspart 6 Day; adjusted for Treatment + Sequence + Period + Age Stratum + Baseline HbA1c; where participant is treated as a random effect.|||0.56|-0.05|
72407824|NCT01109316|144323975|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.11|||||TWO_SIDED|95.0|-0.29|0.51|||||Least Squares Mean Difference of Daily Bolus Insulin = Insulin Lispro 6 Day minus Insulin Aspart 6 Day; adjusted for Treatment + Sequence + Period + Baseline Insulin Basal/Bolus/Total Dose + Age Stratum.|||0.51|-0.29|
72407825|NCT01109316|144323975|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.16|||||TWO_SIDED|95.0|-0.41|0.73|||||Least Squares Mean Difference of Daily Bolus Insulin = Insulin Lispro 6 Day minus Insulin Aspart 6 Day; adjusted for Treatment + Sequence + Period + Baseline Insulin Basal/Bolus/Total Dose + Age Stratum.|||0.73|-0.41|
72407826|NCT01109316|144323975|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.03|||||TWO_SIDED|95.0|-0.18|0.24|||||Least Squares Mean Difference of Daily Bolus Insulin = Insulin Lispro 6 Day minus Insulin Aspart 6 Day; adjusted for Treatment + Sequence + Period + Baseline Insulin Basal/Bolus/Total Dose + Age Stratum.|||0.24|-0.18|
72407827|NCT01109316|144323975|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.14|||||TWO_SIDED|95.0|-0.56|0.27|||||Least Squares Mean Difference of Daily Bolus Insulin = Insulin Lispro 6 Day minus Insulin Aspart 6 Day; adjusted for Treatment + Sequence + Period + Baseline Insulin Basal/Bolus/Total Dose + Age Stratum.|||0.27|-0.56|
72407828|NCT01109316|144323975|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.06|||||TWO_SIDED|95.0|-0.48|0.6|||||Least Squares Mean Difference of Daily Bolus Insulin = Insulin Lispro 6 Day minus Insulin Aspart 6 Day; adjusted for Treatment + Sequence + Period + Baseline Insulin Basal/Bolus/Total Dose + Age Stratum.|||0.60|-0.48|
72407829|NCT01109316|144323975|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.1|||||TWO_SIDED|95.0|-0.85|0.65|||||Least Squares Mean Difference of Daily Bolus Insulin = Insulin Lispro 6 Day minus Insulin Aspart 6 Day; adjusted for Treatment + Sequence + Period + Baseline Insulin Basal/Bolus/Total Dose + Age Stratum.|||0.65|-0.85|
72407830|NCT01109316|144323976|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.06|||||TWO_SIDED|95.0|-0.02|0.14|||||Least Squares Mean Difference = Insulin Lispro 6 Day minus Insulin Aspart 6 Day; adjusted for Treatment + Period + Sequence + Baseline HbA1c.|||0.14|-0.02|
72407831|NCT01109316|144323976|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.09|||||TWO_SIDED|95.0|0.01|0.18|||||Least Squares Mean Difference = Insulin Lispro 6 Day minus Insulin Aspart 6 Day; adjusted for Treatment + Period + Sequence + Baseline HbA1c.|||0.18|0.01|
72407832|NCT01109316|144323977|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.93|||||TWO_SIDED|95.0|0.5|1.75|||||Odds Ratio of HbA1c ≤6.5% for Insulin Lispro 6 Day versus Insulin Aspart 6 Day.|||1.75|0.50|
72407833|NCT01109316|144323977|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.69|||||TWO_SIDED|95.0|0.29|1.67|||||Odds Ratio of HbA1c ≤6.5% for Insulin Lispro 6 Day versus Insulin Lispro 2 Day.|||1.67|0.29|
72407834|NCT01109316|144323977|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.89|||||TWO_SIDED|95.0|0.56|1.41|||||Odds Ratio of HbA1c \<7% for Insulin Lispro 6 Day versus Insulin Aspart 6 Day.|||1.41|0.56|
72407835|NCT01109316|144323977|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.04|||||TWO_SIDED|95.0|0.66|1.64|||||Odds Ratio of HbA1c \<7% for Insulin Lispro 6 Day versus Insulin Lispro 2 Day.|||1.64|0.66|
72407836|NCT01109316|144323978|SUPERIORITY_OR_OTHER|||||||1||95.0||||P-value computed using Treatment comparison Gart's Test. Participants represented in both treatment groups and with non-missing incidence value in each treatment period are used for p-value calculation.|Gart's Test|||||||1.00
72407837|NCT01109316|144323979|SUPERIORITY_OR_OTHER|||||||0.164||95.0||||P-value computed using a negative binomial test including factors for treatment, period, and sequence.|Negative Binomial Test|||||||0.164
72407838|NCT01109316|144323979|SUPERIORITY_OR_OTHER|||||||0.185||95.0||||P-value computed using a negative binomial test including factors for treatment, period, and sequence.|Negative Binomial Test|||||||0.185
72407839|NCT01109316|144323980|SUPERIORITY_OR_OTHER|||||||0.736||95.0||||P-value for Premature Reservoir Change. P-value computed using Treatment comparison Gart's Test. Participants represented in both treatment groups and with non-missing incidence value in each treatment period are used for p-value calculation.|Gart's Test|||||||0.736
72407840|NCT01109316|144323980|SUPERIORITY_OR_OTHER|||||||0.006||95.0||||P-value for Premature Reservoir Change. P-value computed using Treatment comparison Gart's Test. Participants represented in both treatment groups and with non-missing incidence value in each treatment period are used for p-value calculation.|Gart's Test|||||||0.006
72407841|NCT01109316|144323980|SUPERIORITY_OR_OTHER|||||||1||95.0||||P-value for Premature Infusion Set Change. P-value computed using Treatment comparison Gart's Test. Participants represented in both treatment groups and with non-missing incidence value in each treatment period are used for p-value calculation.|Gart's Test|||||||1.00
72407842|NCT01109316|144323980|SUPERIORITY_OR_OTHER|||||||0.017||95.0||||P-value for Premature Infusion Set Change. P-value computed using Treatment comparison Gart's Test. Participants represented in both treatment groups and with non-missing incidence value in each treatment period are used for p-value calculation.|Gart's Test|||||||0.017
72407843|NCT01109316|144323981|SUPERIORITY_OR_OTHER|||||||0.471||95.0||||P-value for Premature Reservoir Change. P-value is computed using negative binomial test including factors for treatment, period and sequence.|Negative Binomial Test|||||||0.471
72407844|NCT01109316|144323981|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Premature Reservoir Change. P-value is computed using negative binomial test including factors for treatment, period and sequence.|Negative Binomial Test|||||||<0.001
72407845|NCT01109316|144323981|SUPERIORITY_OR_OTHER|||||||0.737||95.0||||P-value for Premature Infusion Set Change. P-value is computed using negative binomial test including factors for treatment, period and sequence.|Negative Binomial Test|||||||0.737
72529768|NCT01453439|144589279|SUPERIORITY|||||||0.05||||||Degrees of freedom=89.1|Mixed Models Analysis|||"We compared the change in depressive symptoms over time (During Treatment phase) by randomized treatment group (CBT vs. SPT) using a latent growth curve model that included terms for treatment group, time, site, and all their interactions, modeling intercepts and slopes as random effects per person.~Null hypothesis: The rate of improvement in depressive symptoms in the CBT group will not be significantly different from the SPT group \[to be tested\]."||||.05
72571882|NCT02912650|144671807|SUPERIORITY_OR_OTHER||LS Mean Difference|0.27||||0.052|TWO_SIDED|95.0|0.0|0.54|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.54|-0.00|0.052
72571883|NCT02912650|144671807|SUPERIORITY_OR_OTHER||LS Mean Difference|0.18||||0.196|TWO_SIDED|95.0|-0.09|0.45|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.45|-0.09|0.196
72571884|NCT02912650|144671807|SUPERIORITY_OR_OTHER||LS Mean Difference|0.09||||0.364|TWO_SIDED|95.0|-0.1|0.28|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.28|-0.10|0.364
72571885|NCT02912650|144671807|SUPERIORITY_OR_OTHER||LS Mean Difference|0.25||||0.071|TWO_SIDED|95.0|-0.02|0.52|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.52|-0.02|0.071
72625618|NCT00879398|144780569|SUPERIORITY_OR_OTHER|||||||0.0239||95.0||||Statistical significant level: 0.05|Fisher Exact|||Comparison among Daily Dose of Toviaz: 3 mg, 4 mg, \>4 mg to \<8 mg, and 8 mg.||||0.0239
72407846|NCT01109316|144323981|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Premature Infusion Set Change. P-value is computed using negative binomial test including factors for treatment, period and sequence.|Negative Binomial Test|||||||<0.001
72407847|NCT01109316|144323983|SUPERIORITY_OR_OTHER|||||||0.006||95.0||||P-value is computed using negative binomial test including factors for treatment, period and sequence.|Negative Binomial Test|||||||0.006
72407848|NCT01109316|144323983|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||P-value is computed using negative binomial test including factors for treatment, period and sequence.|Negative Binomial Test|||||||0.002
72407849|NCT01109316|144323984|SUPERIORITY_OR_OTHER|||||||0.06||95.0||||P-value computed using crossover model. Response = Treatment + Sequence + Period + Age stratum + Baseline Body Weight.|Crossover Model|||||||0.060
72407850|NCT01109316|144323984|SUPERIORITY_OR_OTHER|||||||0.486||95.0||||P-value computed using crossover model. Response = Treatment + Sequence + Period + Age stratum + Baseline Body Weight.|Crossover Model|||||||0.486
72407851|NCT01109316|144323985|SUPERIORITY_OR_OTHER|||||||0.056||95.0||||P-value is for Systolic Blood Pressure. P-value computed using crossover model. Response = Treatment + Sequence + Period + Age stratum + Baseline Systolic Blood Pressure.|Crossover Model|||||||0.056
72529769|NCT01453439|144589279|SUPERIORITY|||||||0.26||||||Degrees of freedom=63.7|Mixed Models Analysis|||"We compared the change in depressive symptoms over time (during the follow-up phase), by randomized treatment group (CBT vs. SPT) using a latent growth curve model that included terms for treatment group, time, site, and all their interactions, modeling intercepts and slopes as random effects per person.~Null hypothesis: The rate of change in depressive symptoms in the CBT group will not be significantly different from the SPT group during follow-up \[to be tested\]."||||.26
72571886|NCT02912650|144671807|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.02||||0.865||95.0|-0.2|0.17|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.17|-0.20|0.865
72571887|NCT02912650|144671807|SUPERIORITY_OR_OTHER||LS Mean Difference|0.11||||0.238|TWO_SIDED|95.0|-0.08|0.3|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.30|-0.08|0.238
72571888|NCT02912650|144671807|SUPERIORITY_OR_OTHER||LS Mean Difference|0.26||||0.054|TWO_SIDED|95.0|0.0|0.53|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.53|-0.00|0.054
72571889|NCT02912650|144671807|SUPERIORITY_OR_OTHER||LS Mean Difference|0.13||||0.335|TWO_SIDED|95.0|-0.14|0.4|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.40|-0.14|0.335
72571890|NCT02912650|144671807|SUPERIORITY_OR_OTHER||LS Mean Difference|0.13||||0.176|TWO_SIDED|95.0|-0.06|0.32|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.32|-0.06|0.176
72571891|NCT02912650|144671808|SUPERIORITY_OR_OTHER||LS Mean Difference|0.48||||0.002|TWO_SIDED|95.0|0.18|0.77|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.77|0.18|0.002
72571892|NCT02912650|144671808|SUPERIORITY_OR_OTHER||LS Mean Difference|0.18||||0.098|TWO_SIDED|95.0|-0.03|0.38|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.38|-0.03|0.098
72571893|NCT02912650|144671808|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.04||||0.719|TWO_SIDED|95.0|-0.25|0.17|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.17|-0.25|0.719
72571894|NCT02912650|144671808|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3||||0.048|TWO_SIDED|95.0|0.0|0.6|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.60|0.00|0.048
72571895|NCT02912650|144671808|SUPERIORITY_OR_OTHER||LS Mean Difference|0.51|||<|0.001|TWO_SIDED|95.0|0.21|0.81|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.81|0.21|<0.001
72571896|NCT02912650|144671808|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.21||||0.046|TWO_SIDED|95.0|-0.42|0.0|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||-0.00|-0.42|0.046
72571897|NCT02912650|144671808|SUPERIORITY_OR_OTHER||LS Mean Difference|1.52|||<|0.001|TWO_SIDED|95.0|1.05|1.99|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.99|1.05|<0.001
72625619|NCT00879398|144780569|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Statistical significant level: 0.05|Chi-squared|||Completion vs Discontinuation||||<0.0001
72625620|NCT00879398|144780569|SUPERIORITY_OR_OTHER|||||||0.5889||95.0||||Statistical significant level: 0.05|Fisher Exact|||Total Administration Period \<274 days vs Total Administration Period ≥ 274 days||||0.5889
72407852|NCT01109316|144323985|SUPERIORITY_OR_OTHER|||||||0.805||95.0||||P-value is for Systolic Blood Pressure. P-value computed using crossover model. Response = Treatment + Sequence + Period + Age stratum + Baseline Systolic Blood Pressure.|Crossover Model|||||||0.805
72407853|NCT01109316|144323985|SUPERIORITY_OR_OTHER|||||||0.02||95.0||||P-value is for Diastolic Blood Pressure. P-value computed using crossover model. Response = Treatment + Sequence + Period + Age stratum + Baseline Diastolic Blood Pressure.|Crossover Model|||||||0.020
72407854|NCT01109316|144323985|SUPERIORITY_OR_OTHER|||||||0.051||95.0||||P-value is for Diastolic Blood Pressure. P-value computed using crossover model. Response = Treatment + Sequence + Period + Age stratum + Baseline Diastolic Blood Pressure.|Crossover Model|||||||0.051
72407855|NCT01302392|144323993|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.975||||0.4172|TWO_SIDED|95.0|0.76|1.249||Based on 1-sided test.|Log Rank|Analysis was stratified by the number of previous therapies (3 vs 4 vs ≥ 5) and geographical region (Europe vs. non-Europe)||||1.249|0.760|0.4172
72407856|NCT01702233|144324011|NON_INFERIORITY_OR_EQUIVALENCE|All statistical analyses were of exploratory nature. A one-sided test of non-inferiority of Traumeel®S with respect to dexamethasone at level 0.025 was computed using an analysis of covariance (ANCOVA) model with treatment group as qualitative factor and the baseline value of the abduction rotation pain VAS for active external rotation as a covariate. The test decision was based on a one-sided 97.5% confidence interval . The non-inferiority margin was set to 13 mm on a 0-100 mm VAS scale.|Mean Difference (Final Values)|13.0|STANDARD_DEVIATION|13.0|<|0.05|ONE_SIDED|95.0||97.5|||ANCOVA|||||97.5||<0.05
72407857|NCT04646616|144324043|NON_INFERIORITY|This is a single-group, of outcome measured at baseline and at 3 months. We hypothesized there would be an improvement or sustainability of the protective behaviours.|Mean Difference (Net)|0.14|STANDARD_ERROR_OF_MEAN|0.13||0.28|TWO_SIDED|95.0|-0.12|0.39|||t-test, 2 sided|||This is a single-group study. Selected outcomes were measured at baseline (first interaction with the community popular opinion leader (POL) and 3 months after.||0.39|-0.12|0.28
72407858|NCT04646616|144324044|OTHER|Test of proportions|difference in proportion|-0.007|STANDARD_ERROR_OF_MEAN|0.04||0.85|TWO_SIDED|95.0|-0.08|0.07|||Test of proportions|||Two sample test of proportions, testing whether the proportion of participants who lack health access at baseline and 3 months is equal (null hypothesis)||0.07|-0.08|0.85
72529770|NCT01453439|144589280|SUPERIORITY|||||||0.04||||||Degrees of freedom=91.4|Mixed Models Analysis|||"We compared the change in Quality of life satisfaction over time (During treatment phase) by randomized treatment group (CBT vs. SPT) using a latent growth curve model that included terms for treatment group, time, site, and all their interactions, modeling intercepts and slopes as random effects per person.~Null hypothesis: The rate of change in Quality of life satisfaction severity in the CBT group will not be significantly different from the SPT group \[to be tested\]."||||.04
72529771|NCT01453439|144589280|SUPERIORITY|||||||0.82||||||Degrees of freedom=74.7|Mixed Models Analysis|||"We compared the change in the quality of life satisfaction over time (during the follow-up phase), by randomized treatment group (CBT vs. SPT) using a latent growth curve model that included terms for treatment group, time, site, and all their interactions, modeling intercepts and slopes as random effects per person.~Null hypothesis: The rate of change in the quality of life satisfaction in the CBT group will not be significantly different from the SPT group during follow-up \[to be tested\]."||||.82
72625621|NCT00879398|144780569|SUPERIORITY_OR_OTHER|||||||0.001||95.0||||Statistical significant level: 0.05|Chi-squared|||Concurrent Medication: Yes vs Concurrent Medication: No||||0.0010
72407859|NCT04646616|144324045|OTHER|Test of proportions.|difference in proportion|0.07|STANDARD_ERROR_OF_MEAN|0.58||0.19|TWO_SIDED|95.0|-0.04|0.19|||Test of proportions|||Test of proportions. Testing whether the proportion of participants who had a SAVAME factor at baseline and 3 months is equal (null hypothesis)||0.19|-0.04|0.19
72407860|NCT04646616|144324046|OTHER|Test of proportions.|difference in proportion|0.067|STANDARD_ERROR_OF_MEAN|0.06||0.23|TWO_SIDED|95.0|-0.04|0.18|||Test of proportions|||Test of proportions. Testing whether the proportion of participants who lack access to SAVAME related services at baseline and 3 months is equal (null hypothesis)||0.18|-0.04|0.23
72407861|NCT03049813|144324047|SUPERIORITY|||||||0.027||||||One-sided p value|Regression, Logistic|Adjusted for baseline year of study participation, problematic substance use, social cognition, community functioning, and negative symptoms - anergia||||||0.027
72407862|NCT03049813|144324047|SUPERIORITY|||||||0.0765||||||1-sided p-value|Chi-squared|||||||0.0765
72407863|NCT03049813|144324048|SUPERIORITY|||||||0.062||||||One-sided p value|Regression, Cox|Adjusting for baseline year of study participation, problematic substance use, social cognition, community functioning, and negative symptoms anergia||||||0.062
72407864|NCT03049813|144324049|SUPERIORITY|||||||0.006||||||Adjusting for baseline year of study participation, problematic substance use, social cognition, community functioning, negative symptoms - anergia|Regression, Linear|||||||0.006
72407865|NCT03049813|144324050|SUPERIORITY|||||||0.013||||||Mixed-effects linear regression models. Covariates include: baseline year, problematic substance use, social cognition, community functioning, and negative symptoms (anergia). One-sided p value.|Regression, Linear|||||||0.013
72407866|NCT03049813|144324051|SUPERIORITY|||||||0.019||||||Mixed-effects linear regression models. Covariates include: baseline year, problematic substance use, social cognition, community functioning, and negative symptoms (anergia). One sided p-value.|Regression, Linear|||||||0.019
72407867|NCT03049813|144324052|SUPERIORITY|||||||0.692||||||Mixed-effects linear regression models. Covariates include: baseline year, problematic substance use, social cognition, community functioning, and negative symptoms (anergia).|Regression, Linear|||For this analysis, only participants who completed both pre-test and posttest were included. If someone completed a pre-test SSPA, but not a posttest SSPA, they were not included in the analysis.||||0.692
72407868|NCT01813019|144324054|SUPERIORITY_OR_OTHER|||||||0.671|||||||Mixed Models Analysis|||||||0.671
72407869|NCT00094653|144324105|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.68||||0.0004|TWO_SIDED|95.0|0.55|0.85|||Stratified Log Rank||Cox model for Hazard ratios (HR) and log-rank test p-values were stratified by baseline M-stage at randomization (M0, M1a, M1b vs. M1c) and prior treatment with IL-2 (Yes vs. No).|||0.85|0.55|0.0004
72625622|NCT01380080|144780584|SUPERIORITY_OR_OTHER_LEGACY||Cumulative probability difference|-0.06||||0.97|TWO_SIDED|95.0|-3.05|2.94|||z-test|||Treatment comparison was made using the difference (arm B- arm A) in the Kaplan-Meier estimate for 24 week cumulative probability of death or unknown vital status with 95% confidence interval||2.94|-3.05|0.97
72571898|NCT02912650|144671808|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3||||0.069|TWO_SIDED|95.0|-0.02|0.63|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.63|-0.02|0.069
72571899|NCT02912650|144671808|SUPERIORITY_OR_OTHER||LS Mean Difference|0.09||||0.604|TWO_SIDED|95.0|-0.24|0.42|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.42|-0.24|0.604
72407870|NCT00094653|144324106|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.66||||0.0026|TWO_SIDED|95.0|0.51|0.87|||Stratified Log Rank||Cox model for Hazard ratios (HR) and log-rank test p-values were stratified by baseline M-stage at randomization (M0, M1a, M1b vs. M1c) and prior treatment with IL-2 (Yes vs. No).|||0.87|0.51|0.0026
72407871|NCT00094653|144324106|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.04||||0.7575|TWO_SIDED|95.0|0.83|1.3|||Stratified Log Rank||Cox model for Hazard ratios (HR) and log-rank test p-values were stratified by baseline M-stage at randomization (M0, M1a, M1b vs. M1c) and prior treatment with IL-2 (Yes vs. No).|||1.30|0.83|0.7575
72407872|NCT00094653|144324108|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.81|||||TWO_SIDED|95.0|0.66|1.0|||||Cox model for Hazard ratios (HR) were stratified by M-stage at randomization (M0, M1a, M1b vs. M1c) and prior treatment with IL-2 (Yes vs. No).|||1.00|0.66|
72529772|NCT01453439|144589281|SUPERIORITY||Mean Difference (Net)|0.7937|STANDARD_ERROR_OF_MEAN|0.3007||0.0095|TWO_SIDED|||||Effect of interest: Treatment main effect, two-sided alpha = 0.05 effect adjusted for site effects, time effects, and interactions|ANOVA|repeated measures 3-way ANOVA (treatment type, site, time (repeated)) Effect of interest: main effect of treatment: F(num df=1, den df=112) = 5.17|Least Squares Means difference|Null hypothesis: There is no significant different in the perceived credibility of CBT and SPT.||||0.0095
72529773|NCT01453439|144589285|SUPERIORITY|||||||0.3||||||Degrees of freedom=88.0|Mixed Models Analysis|||"We compared the change in social functioning over time (During Treatment phase) by randomized treatment group (CBT vs. SPT) using a latent growth curve model that included terms for treatment group, time, site, and all their interactions, modeling intercepts, and slopes as random effects per person.~Null hypothesis: The rate of improvement in social functioning in the CBT group will not be significantly different from the SPT group \[to be tested\]."||||.30
72571900|NCT02912650|144671808|SUPERIORITY_OR_OTHER||LS Mean Difference|1.22|||<|0.001|TWO_SIDED|95.0|0.75|1.69|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.69|0.75|<0.001
72625623|NCT00375713|144780603|NON_INFERIORITY_OR_EQUIVALENCE|The pre-set threshold for non inferiority is -10%.|Difference in proportion of responders|0.00069213||||||95.0|-0.0875|0.0888||||||The lower bound of the 95% two sided confidence interval for the difference (Levocetirizine - Cetirizine) in percentage of responders is compared to the pre-set threshold for non inferiority (-10% which is equal to -0.1 for the proportion of responders). Standard method for estimation of the difference in proportions incl. confidence interval using normal approximation is used.||0.0888|-0.0875|
72407873|NCT00094653|144324108|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.64|||||TWO_SIDED|95.0|0.5|0.83|||||Cox model for Hazard ratios (HR) were stratified by M-stage at randomization (M0, M1a, M1b vs. M1c) and prior treatment with IL-2 (Yes vs. No).|||0.83|0.50|
72407874|NCT00094653|144324108|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.25|||||TWO_SIDED|95.0|1.01|1.53|||||Cox model for Hazard ratios (HR) were stratified by M-stage at randomization (M0, M1a, M1b vs. M1c) and prior treatment with IL-2 (Yes vs. No).|||1.53|1.01|
72407875|NCT00094653|144324110|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.81|||||TWO_SIDED|95.0|0.66|1.0|||||Cox model for Hazard ratios (HR) were stratified by M-stage at randomization (M0, M1a, M1b vs. M1c) and prior treatment with IL-2 (Yes vs. No).|||1.00|0.66|
72407876|NCT00094653|144324110|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.64|||||TWO_SIDED|95.0|0.5|0.83|||||Cox model for Hazard ratios (HR) were stratified by M-stage at randomization (M0, M1a, M1b vs. M1c) and prior treatment with IL-2 (Yes vs. No).|||0.83|0.50|
72571901|NCT02912650|144671808|SUPERIORITY_OR_OTHER||LS Mean Difference|1.43|||<|0.001|TWO_SIDED|95.0|0.96|1.9|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.90|0.96|<0.001
72571902|NCT02912650|144671808|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.22||||0.2|TWO_SIDED|95.0|-0.54|0.11|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.11|-0.54|0.200
72571903|NCT02912650|144671808|SUPERIORITY_OR_OTHER||LS Mean Difference|2.89|||<|0.001|TWO_SIDED|95.0|2.32|3.46|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||3.46|2.32|<0.001
72571904|NCT02912650|144671808|SUPERIORITY_OR_OTHER||LS Mean Difference|0.63||||0.002|TWO_SIDED|95.0|0.23|1.03|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.03|0.23|0.002
72571905|NCT02912650|144671808|SUPERIORITY_OR_OTHER||LS Mean Difference|0.55||||0.008|TWO_SIDED|95.0|0.14|0.95|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.95|0.14|0.008
72407877|NCT00094653|144324110|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.25|||||TWO_SIDED|95.0|1.01|1.53|||||Cox model for Hazard ratios (HR) were stratified by M-stage at randomization (M0, M1a, M1b vs. M1c) and prior treatment with IL-2 (Yes vs. No).|||1.53|1.01|
72571906|NCT02912650|144671808|SUPERIORITY_OR_OTHER||LS Mean Difference|2.26|||<|0.001|TWO_SIDED|95.0|1.69|2.83|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||2.83|1.69|<0.001
72571907|NCT02912650|144671808|SUPERIORITY_OR_OTHER||LS Mean Difference|2.34|||<|0.001|TWO_SIDED|95.0|1.77|2.91|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||2.91|1.77|<0.001
72571908|NCT02912650|144671808|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.08||||0.685|TWO_SIDED|95.0|-0.49|0.32|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.32|-0.49|0.685
72571909|NCT02912650|144671808|SUPERIORITY_OR_OTHER||LS Mean Difference|3.35|||<|0.001|TWO_SIDED|95.0|2.77|3.93|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||3.93|2.77|<0.001
72571910|NCT02912650|144671808|SUPERIORITY_OR_OTHER||LS Mean Difference|0.66||||0.001|TWO_SIDED|95.0|0.26|1.07|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.07|0.26|0.001
72625624|NCT00375713|144780604|SUPERIORITY_OR_OTHER|||||||0.4369||95.0|||||ANCOVA|Pruritus score is adjusted on pruritus Baseline score.||The mean daily pruritus score at Day 14 visit or at study completion was analyzed using an analysis of covariance (ANCOVA) model, including pruritus severity score of the day before the randomization as a covariate and treatment group as a factor||||0.4369
72625625|NCT00375713|144780605|SUPERIORITY_OR_OTHER|||||||0.3549||95.0|||||ANCOVA|pruritus severity score at baseline has been used as a covariate.||The categorized duration of Pruritus at endpoint during the 14 day treatment period was analyzed using an analysis of covariance (ANCOVA) model, including pruritus severity score of the day before the randomization as a covariate and treatment group as a factor.||||0.3549
72369170|NCT00494676|144248423|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.2|||=|0.001|TWO_SIDED|95.0|1.8|21.0|||McNemar||The marginal odds ratio based on discordant pairs was computed.|The analysis used a McNemar test for data combined across both periods of the crossover. We estimated that 70% and 35% of participants would say yes to the real and sham prisms, respectively. For a 2-tailed test, the minimum sample size to detect a 35% difference in yes responses to real and sham prisms was 57 participants, assuming 30% overlap (30% said yes to both pairs of glasses), power of 90% and α of 1%. Assuming an attrition rate of 20%, we planned to enroll 68 participants.||21.0|1.8|= 0.001
72529774|NCT01453439|144589285|SUPERIORITY|||||||0.85||||||Degrees of freedom=74.5|Mixed Models Analysis|||"We compared the change in social functioning over time (during the follow-up phase), by randomized treatment group (CBT vs. SPT) using a latent growth curve model that included terms for treatment group, time, site, and all their interactions, modeling intercepts and slopes as random effects per person.~Null hypothesis: The rate of improvement in social functioning CBT group will not be significantly different from the SPT group during follow-up \[to be tested\]."||||.85
72529775|NCT01453439|144589286|SUPERIORITY||Mean Difference (Net)|1.5867|STANDARD_ERROR_OF_MEAN|0.6882||0.0235|TWO_SIDED|||||a priori significance level: 2-sided alpha = 0.05 effect adjusted for site effects, time effects, and interactions|ANOVA|repeated measures 3-way ANOVA (treatment type, site, time (repeated)) Effect of interest: main effect of treatment - F(num def=1,den df=79.9) = 15.55|Least Squares Means difference|Null hypothesis: There is no significant difference in treatment satisfaction between patients with BDD assigned to CBT vs. SPT.||||0.0235
72529776|NCT01453439|144589287|SUPERIORITY||Median Difference (Net)|9.439|STANDARD_ERROR_OF_MEAN|3.4259||0.0069|TWO_SIDED|||||a priori significance level: 2-sided alpha=0.05 effect adjusted for site effects, time effects, and interactions|ANOVA|repeated measures 3-way ANOVA (treatment group, site, time (repeated)) effect of interest: main effect of treatment: F(num df=1, den df=110) = 7.59|Least Squares Mean difference|Null hypotheses: There is no significant difference in patient expectancy of improvement between BDD patients assigned to CBT vs. SPT.||||0.0069
72529777|NCT04542525|144589332|SUPERIORITY||||||<|0.0001|||||||Exact Test of Binomial Proportion||||P-value is provided from exact test of binomial proportion (one-sided alpha = 2.5%) comparing PanOptix Toric Trifocal IOL Model TFNT20 with historical threshold 29.2 % (rate calculated for a non-toric IOL in Japanese study patients that would qualify for a T2 lens using the same toric calculator).|||<0.0001
72529778|NCT00545740|144589346|SUPERIORITY_OR_OTHER_LEGACY|||||||0.063||95.0|||||Cochran-Mantel-Haenszel|||||||0.063
72529779|NCT00545740|144589346|SUPERIORITY_OR_OTHER_LEGACY|||||||0.736||95.0|||||Cochran-Mantel-Haenszel|||||||0.736
72529780|NCT00545740|144589346|SUPERIORITY_OR_OTHER_LEGACY|||||||0.78||95.0|||||Cochran-Mantel-Haenszel|||||||0.780
72529781|NCT00545740|144589348|SUPERIORITY_OR_OTHER_LEGACY|||||||0.047||95.0|||||Cochran-Mantel-Haenszel|||||||0.047
72529782|NCT00545740|144589348|SUPERIORITY_OR_OTHER_LEGACY|||||||0.741||95.0|||||Cochran-Mantel-Haenszel|||||||0.741
72529783|NCT00545740|144589348|SUPERIORITY_OR_OTHER_LEGACY|||||||0.78||95.0|||||Cochran-Mantel-Haenszel|||||||0.780
72529784|NCT02625610|144589353|SUPERIORITY||Hazard Ratio (HR)|0.91||||0.1779|TWO_SIDED|95.0|0.74|1.11|||Log Rank|The treatment arms were compared using a stratified, 1-sided, log rank Test. The stratification factor was region (Asia versus non Asia).||||1.11|0.74|0.1779
72529785|NCT02625610|144589354|SUPERIORITY||Hazard Ratio (HR)|1.04|||||TWO_SIDED|95.0|0.85|1.28||||||||1.28|0.85|
72529786|NCT02625610|144589356|SUPERIORITY||Odds Ratio (OR)|0.91|||||TWO_SIDED|95.0|0.55|1.51||||||||1.51|0.55|
72529787|NCT03459794|144589366|OTHER|||||||||||||||||All measurements were compared to the same group at t=0, that is before the drug or placebo was administered. We compared the expression levels for each transcript, using the mean levels in each group, not at the individual participant level.|We analyzed the changes is level for each cytokine between the groups. P value was adjusted for multiple comparisons and significance determined using the Holm-Sidak method. The threshold value for statistical significance for the mean value between groups was set at p =\<0.05 for each cytokine measured. The number of cytokines that met this threshold is reported.|||
72529788|NCT03459794|144589367|OTHER|||||||||||||||||All measurements were compared to the same treated/control group at t=0, before the drug or placebo was administered. We compared the expression levels for each transcript, using the mean levels in each group, not at the individual participant level.|We compared the expression levels for each transcript, using the mean levels in each group, not at the individual participant level. The p-value for each transcript is adjusted for multiple comparisons across all 770 transcripts, using the Benjamini-Yekutieli method. The number reported is the number of transcripts where p=\<0.05.|||
72529789|NCT03459794|144589368|OTHER||||||<|0.05|||||||t-test, 1 sided|||||||<0.05
72529790|NCT02177942|144589370|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.03||||0.6931|TWO_SIDED|95.0|-0.2|0.13|||ANCOVA||Difference is test treatment minus control treatment such that a positive difference favours the test treatment.|||0.13|-0.20|0.6931
72529791|NCT01351415|144589379|SUPERIORITY_OR_OTHER||Stratified Hazard Ratio|0.84||||0.1044|TWO_SIDED|90.0|0.71|1.0|||Stratified Log-Rank test|||The stratification factors for Log-Rank test and Hazard Ratio (HR) are the type of planned 2nd-line SoC treatment, the number of cycles of bevacizumab maintenance treatment prior to first PD and smoking status.||1.00|0.71|0.1044
72529792|NCT01351415|144589380|SUPERIORITY_OR_OTHER||Stratified Hazard Ratio|0.83||||0.0573|TWO_SIDED|90.0|0.7|0.98|||Stratified Log-Rank test|||PFS 2: The stratification factors for Log-Rank test are the type of planned 2nd-line SoC treatment, the number of cycles of bevacizumab maintenance treatment prior to PD1 and the smoking status.||0.98|0.70|0.0573
72625626|NCT00375713|144780606|SUPERIORITY_OR_OTHER|||||||0.7518||95.0|||||Cochran-Mantel-Haenszel|stratified on the prurity severity score at the previous day of randomization.||||||0.7518
72529793|NCT01351415|144589380|SUPERIORITY_OR_OTHER||Stratified Hazard Ratio|0.63||||0.0045|TWO_SIDED|90.0|0.49|0.83|||Stratified Log-Rank test|||PFS 3: The stratification factors for Log-Rank test are the type of planned 2nd-line SoC treatment, the number of cycles of bevacizumab maintenance treatment prior to PD1 and the smoking status.||0.83|0.49|0.0045
72529794|NCT01351415|144589381|SUPERIORITY_OR_OTHER||Estimated difference in response rate|0.0237||||0.081|TWO_SIDED|90.0|-0.0156|0.063|||Stratified Cochran-Mantel-Haenszel test|||The stratification factors for Cochran-Mantel-Haenszel test are the type of planned 2nd-line SoC treatment, the number of cycles of Bevacizumab maintenance treatment prior to PD1 and the smoking status.||0.0630|-0.0156|0.0810
72529795|NCT01351415|144589382|SUPERIORITY_OR_OTHER||Estimated difference in Disease Control|0.0326||||0.0218|TWO_SIDED|90.0|-0.0288|0.094|||Stratified Cochran-Mantel-Haenszel test|||The stratification factors for Cochran-Mantel-Haenszel test are the type of planned 2nd-line SoC treatment, the number of cycles of Bevacizumab maintenance treatment prior to PD1 and the smoking status.||0.0940|-0.0288|0.0218
72529796|NCT01351415|144589383|SUPERIORITY_OR_OTHER||Stratified Hazard Ratio|0.29||||0.06|TWO_SIDED|90.0|0.09|0.9|||Stratified Log-Rank test|||The stratification factors for Log-Rank test are the type of planned 2nd-line SoC treatment, the number of cycles of Bevacizumab maintenance treatment prior to PD1 and the smoking status.||0.90|0.09|0.0600
72529797|NCT01351415|144589385|SUPERIORITY_OR_OTHER||Stratified Hazard Ratio|0.79||||0.0311|TWO_SIDED|90.0|0.65|0.95|||Stratified Log-Rank test|||TTP2: The stratification factors for Log-Rank test are the type of planned 2nd-line SoC treatment, the number of cycles of Bevacizumab maintenance treatment prior to PD1 and the smoking status.||0.95|0.65|0.0311
72529798|NCT01351415|144589385|SUPERIORITY_OR_OTHER||Stratified Hazard Ratio|0.69||||0.0326|TWO_SIDED|90.0|0.52|0.92|||Stratified Log-Rank test|||TTP3: The stratification factors for Log-Rank test are the type of planned 2nd-line SoC treatment, the number of cycles of Bevacizumab maintenance treatment prior to PD1 and the smoking status.||0.92|0.52|0.0326
72529799|NCT01646255|144589396|SUPERIORITY_OR_OTHER||Least Square Mean|-1.2|||=|0.0002|TWO_SIDED|95.0|-1.83|-0.57||Primary efficacy analyses was made with confirmatory 2-sided test with significance level 0.05.|ANCOVA|||"Estimate of treatment effect has been obtained from an analysis of covariance (ANCOVA) model to the change from Baseline value in absolute time spent off. The ANCOVA model contained treatment and (pooled) site as factors and Baseline off time as covariate. A last observation carried forward (LOCF) imputation approach was used for missing values (during both Titration and Maintenance Periods) for the primary efficacy analysis."||-0.57|-1.83|=0.0002
72529800|NCT02380703|144589420|SUPERIORITY||Hazard Ratio (HR)|1.34||||0.29|TWO_SIDED|95.0|0.78|2.32||For participants who dropped out, their time until study attrition was used as the exposure period; and they were carried forward as part of the overall incidence count.|Regression, Cox|||Sample-size calculations were performed, based on the ability to detect a small-to-moderate difference (Cohen's h = 0.4) in rate of aggression onset over a 1-year period between APT and EU-PC, assuming 80% power and a type I error rate of 5%. Given an anticipated rate of aggression onset over 1 year of 37% for EU-PC, an ES of h = 0.4 allows detection of aggression onset in APT as high as 19%. Given this effect size and up to 10% attrition, our goal was to include 220 total participants.||2.32|0.78|0.29
72529801|NCT02380703|144589420|EQUIVALENCE|Examination of whether the presence of aggression is equivalent between APT and EU-PC|Difference in frequencies|1.21||||0.27|TWO_SIDED|||||Association between presence of aggression and condition (APT vs EU-PC).|Chi-squared|X2(1) = 1.21||||||0.27
72529802|NCT02380703|144589421|SUPERIORITY||F-statistic|1.59||||0.19|TWO_SIDED|||||P value for interaction between treatment arm and time|Mixed Models Analysis||"Interaction between time and treatment arm:~Numerator df = 3, denominator df = 510"|"Differences between APT and EU-PC in change over time (baseline, and 3, 6 and 12 months) for our secondary outcomes were evaluated using individual linear growth curve models (SAS Proc Mixed, SAS Institute, Inc., Cary, NC) with an autoregressive covariance structure type.~The main interest was the interaction between group (APT vs EU-PC) and time."||||0.19
72529803|NCT02380703|144589422|SUPERIORITY||F-statistic|2.43||||0.06|TWO_SIDED|||||P value for interaction between treatment arm and time|Mixed Models Analysis||"Interaction between time and treatment arm:~Numerator df = 3, denominator df = 510"|"Differences between APT and EU-PC in change over time (baseline, and 3, 6 and 12 months) for our secondary outcomes were evaluated using individual linear growth curve models (SAS Proc Mixed, SAS Institute, Inc., Cary, NC) with an autoregressive covariance structure type.~The main interest was the interaction between group (APT vs EU-PC) and time."||||0.06
72529804|NCT02380703|144589423|SUPERIORITY||F-statistic|0.33||||0.8|TWO_SIDED|||||P value for interaction between treatment arm and time|Mixed Models Analysis||"Interaction between time and treatment arm:~Numerator df = 3, denominator df = 510"|"Differences between APT and EU-PC in change over time (baseline, and 3, 6 and 12 months) for our secondary outcomes were evaluated using individual linear growth curve models (SAS Proc Mixed, SAS Institute, Inc., Cary, NC) with an autoregressive covariance structure type.~The main interest was the interaction between group (APT vs EU-PC) and time."||||0.80
72529805|NCT02380703|144589424|SUPERIORITY||F-statistic|0.21||||0.89|TWO_SIDED|||||P value for interaction between treatment arm and time|Mixed Models Analysis||"Interaction between time and treatment arm:~Numerator df = 3, denominator df = 510"|"Differences between APT and EU-PC in change over time (baseline, and 3, 6 and 12 months) for our secondary outcomes were evaluated using individual linear growth curve models (SAS Proc Mixed, SAS Institute, Inc., Cary, NC) with an autoregressive covariance structure type.~The main interest was the interaction between group (APT vs EU-PC) and time."||||0.89
72529806|NCT02380703|144589425|SUPERIORITY||F-statistic|1.48||||0.22|TWO_SIDED|||||P value for interaction between treatment arm and time|Mixed Models Analysis||"Interaction between time and treatment arm:~Numerator df = 3, denominator df = 510"|"Differences between APT and EU-PC in change over time (baseline, and 3, 6 and 12 months) for our secondary outcomes were evaluated using individual linear growth curve models (SAS Proc Mixed, SAS Institute, Inc., Cary, NC) with an autoregressive covariance structure type.~The main interest was the interaction between group (APT vs EU-PC) and time."||||0.22
72529807|NCT02380703|144589426|SUPERIORITY||F-statistic|0.38||||0.77|TWO_SIDED|||||P value for interaction between treatment arm and time|Mixed Models Analysis||"Interaction between time and treatment arm:~Numerator df = 3, denominator df = 510"|"Differences between APT and EU-PC in change over time (baseline, and 3, 6 and 12 months) for our secondary outcomes were evaluated using individual linear growth curve models (SAS Proc Mixed, SAS Institute, Inc., Cary, NC) with an autoregressive covariance structure type.~The main interest was the interaction between group (APT vs EU-PC) and time."||||0.77
72529808|NCT02380703|144589427|SUPERIORITY||F-statistic|0.56||||0.64|TWO_SIDED|||||P value for interaction between treatment arm and time|Mixed Models Analysis||"Interaction between time and treatment arm:~Numerator df = 3, denominator df = 510"|"Differences between APT and EU-PC in change over time (baseline, and 3, 6 and 12 months) for our secondary outcomes were evaluated using individual linear growth curve models (SAS Proc Mixed, SAS Institute, Inc., Cary, NC) with an autoregressive covariance structure type.~The main interest was the interaction between group (APT vs EU-PC) and time."||||0.64
72529809|NCT02417935|144589447|NON_INFERIORITY|If the upper bound of the 95% CI does not exceed 0.51 (pre-defined non-inferiority margin), it will be concluded that duloxetine is not inferior to Pregabalin.|Mean Difference (Final Values)|0.072||||0.7|TWO_SIDED|95.0|-0.295|0.439|||Mixed Models Analysis|||||0.439|-0.295|0.700
72529810|NCT02417935|144589448|OTHER||Mean Difference (Final Values)|-0.2||||0.149|TWO_SIDED|95.0|-0.4|0.1|||Mixed Models Analysis|||||0.1|-0.4|0.149
72529811|NCT02417935|144589449|OTHER||Mean Difference (Final Values)|0.1||||0.535|TWO_SIDED|95.0|-0.3|0.6|||Mixed Models Analysis|||Worst Pain||0.6|-0.3|.535
72529812|NCT02417935|144589449|OTHER||Mean Difference (Final Values)|-0.1||||0.436|TWO_SIDED|95.0|-0.5|0.2|||Mixed Models Analysis|||Least Pain||0.2|-0.5|.436
72529813|NCT02417935|144589449|OTHER||Mean Difference (Final Values)|0.1||||0.534|TWO_SIDED|95.0|-0.2|0.5|||Mixed Models Analysis|||Average Pain||0.5|-0.2|.534
72571911|NCT02912650|144671808|SUPERIORITY_OR_OTHER||LS Mean Difference|0.98|||<|0.001|TWO_SIDED|95.0|0.57|1.39|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.39|0.57|<0.001
72571912|NCT02912650|144671808|SUPERIORITY_OR_OTHER||LS Mean Difference|2.69|||<|0.001|TWO_SIDED|95.0|2.11|3.27|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||3.27|2.11|<0.001
72529814|NCT02417935|144589449|OTHER||Mean Difference (Final Values)|0.0||||0.948|TWO_SIDED|95.0|-0.4|0.4|||Mixed Models Analysis|||Pain Right Now||0.4|-0.4|.948
72529815|NCT02417935|144589449|OTHER||Mean Difference (Final Values)|-0.2||||0.225|TWO_SIDED|95.0|-0.6|0.1|||Mixed Models Analysis|||General Activity||0.1|-0.6|.225
72529816|NCT02417935|144589449|OTHER||Mean Difference (Final Values)|-0.2||||0.276|TWO_SIDED|95.0|-0.6|0.2|||Mixed Models Analysis|||Mood||0.2|-0.6|.276
72529817|NCT02417935|144589449|OTHER||Mean Difference (Final Values)|-0.1||||0.507|TWO_SIDED|95.0|-0.4|0.2|||Mixed Models Analysis|||Walking Ability||0.2|-0.4|.507
72529818|NCT02417935|144589449|OTHER||Mean Difference (Final Values)|-0.2||||0.216|TWO_SIDED|95.0|-0.5|0.1|||Mixed Models Analysis|||Normal Work||0.1|-0.5|.216
72529819|NCT02417935|144589449|OTHER||Mean Difference (Final Values)|-0.2||||0.233|TWO_SIDED|95.0|-0.4|0.1|||Mixed Models Analysis|||Relations with other people||0.1|-0.4|.233
72529820|NCT02417935|144589449|OTHER||Mean Difference (Final Values)|0.0||||0.857|TWO_SIDED|95.0|-0.3|0.3|||Mixed Models Analysis|||Sleep||0.3|-0.3|.857
72529821|NCT02417935|144589449|OTHER||Mean Difference (Final Values)|-0.2||||0.133|TWO_SIDED|95.0|-0.5|0.1|||Mixed Models Analysis|||Enjoyment of life||0.1|-0.5|.133
72529822|NCT02417935|144589449|OTHER||Mean Difference (Final Values)|-0.16||||0.246|TWO_SIDED|95.0|-0.44|0.11|||Mixed Models Analysis|||Average Interference Score||0.11|-0.44|.246
72529823|NCT02417935|144589450|OTHER||Mean Difference (Final Values)|-0.7||||0.627|TWO_SIDED|95.0|-3.6|2.2|||ANCOVA|||Total Score||2.2|-3.6|.627
72529824|NCT02417935|144589450|OTHER||Mean Difference (Final Values)|-0.2||||0.355|TWO_SIDED|95.0|-0.6|0.2|||ANCOVA|||Burning Pain||0.2|-0.6|.355
72571913|NCT02912650|144671808|SUPERIORITY_OR_OTHER||LS Mean Difference|2.37|||<|0.001|TWO_SIDED|95.0|1.79|2.96|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||2.96|1.79|<0.001
72571914|NCT02912650|144671808|SUPERIORITY_OR_OTHER||LS Mean Difference|0.32||||0.132|TWO_SIDED|95.0|-0.1|0.73|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.73|-0.10|0.132
72571915|NCT02912650|144671808|SUPERIORITY_OR_OTHER||LS Mean Difference|3.5|||<|0.001|TWO_SIDED|95.0|2.88|4.13|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||4.13|2.88|<0.001
72529825|NCT02417935|144589450|OTHER||Mean Difference (Final Values)|0.1||||0.731|TWO_SIDED|95.0|-0.3|0.4|||ANCOVA|||Pressing Pain||0.4|-0.3|.731
72529826|NCT02417935|144589450|OTHER||Mean Difference (Final Values)|0.1||||0.721|TWO_SIDED|95.0|-0.3|0.4|||ANCOVA|||Paroxysmal Pain||0.4|-0.3|.721
72529827|NCT02417935|144589450|OTHER||Mean Difference (Final Values)|-0.2||||0.345|TWO_SIDED|95.0|-0.5|0.2|||ANCOVA|||Evoked Pain||0.2|-0.5|.345
72529828|NCT02417935|144589450|OTHER||Mean Difference (Final Values)|-0.1||||0.557|TWO_SIDED|95.0|-0.5|0.3|||ANCOVA|||Paresthesia/Dysesthesia||0.3|-0.5|.557
72529829|NCT02417935|144589451|OTHER||Mean Difference (Final Values)|-0.2||||0.106|TWO_SIDED|95.0|-0.4|0.0|||Mixed Models Analysis|||||0.0|-0.4|.106
72529830|NCT02417935|144589452|OTHER||Mean Difference (Final Values)|0.014||||0.361|TWO_SIDED|95.0|-0.0161|0.0441|||ANCOVA|||||0.0441|-0.0161|.361
72529831|NCT02417935|144589453|OTHER||Mean Difference (Final Values)|0.2||||0.701|TWO_SIDED|95.0|-0.8|1.1|||Mixed Models Analysis|||||1.1|-0.8|.701
72529832|NCT02417935|144589454|OTHER||Mean Difference (Final Values)|0.005||||0.976|TWO_SIDED|95.0|-0.355|0.366|||Mixed Models Analysis|||||0.366|-0.355|.976
72529833|NCT02417935|144589455|OTHER||Mean Difference (Final Values)|0.136||||0.503|TWO_SIDED|95.0|-0.264|0.537|||Mixed Models Analysis|||||0.537|-0.264|.503
72529834|NCT02417935|144589456|OTHER|||||||0.632||||||30% reduction|Fisher Exact|||||||.632
72529835|NCT02417935|144589456|OTHER|||||||0.907|||||||Fisher Exact|||50% Reduction||||.907
72571916|NCT02912650|144671808|SUPERIORITY_OR_OTHER||LS Mean Difference|0.61||||0.007|TWO_SIDED|95.0|0.17|1.05|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.05|0.17|0.007
72571917|NCT02912650|144671808|SUPERIORITY_OR_OTHER||LS Mean Difference|1.35|||<|0.001|TWO_SIDED|95.0|0.91|1.8|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.80|0.91|<0.001
72571918|NCT02912650|144671808|SUPERIORITY_OR_OTHER||LS Mean Difference|2.9|||<|0.001|TWO_SIDED|95.0|2.27|3.52|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||3.52|2.27|<0.001
72529836|NCT01899729|144589485|OTHER|Used mixed effects model||||||0.06|||||||Mixed Models Analysis|||||||0.06
72529837|NCT01454531|144589489|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Paired values|t-test, 2 sided|||The null hypothesis is no changes in IgE-blocking factor values from visit 1 (baseline) to visit 6 (end of treatment) versus the alternative hypothesis of change in IgE-blocking factor values||||<0.001
72529838|NCT01454531|144589490|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Paired samples|t-test, 2 sided|||The null hypothesis is no changes in Phleum specific IgG4 values from visit 1 (baseline) to visit 6 (end of treatment) versus the alternative hypothesis of change in Phleum specific IgG4 values||||<0.001
72529839|NCT01454531|144589491|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||Parallel Line Assay|||Parallel Line Assay is based on the construction of two dose-response regression lines obtained plotting the allergen concentration used to prick test the subjects against the wheal size obtained. ANOVA allows to check for regression, linearity and parallelism. A common slope and y-intercepts are calculated. The CTI is the exponentiation of the difference between y-intercepts divided by the common slope. (Finney D.J., Statistical Method in Biological Assay, 1978).||||<0.01
72529840|NCT02504424|144589498|OTHER||percent of breasts successfully exchange|100.0|||||ONE_SIDED|||||||||Treatment Success includes all breasts which were exchanged successfully in the Per Protocol Cohort, excluding non-device related failures. The Treatment Success Rate per breast is 100% (80/80). Note: Denominator = 80 (86 implanted breasts - 6 breasts). Failed exchange = 4 breasts (non-device related) \& Missing = 2 breasts (patient non-compliant w/study and withdrew consent after treatment).||||
72529841|NCT02504424|144589498|OTHER||% breasts successfully exchanged|100.0|||||ONE_SIDED|||||||||Sensitivity Analysis (Best / Worst Case): Treatment Success by subject for the Per Protocol cohort includes all failures (excluding non-device related failures). The best case analysis considers success if the subject has at least one breast successfully reconstructed, and the worst case analysis considers it a failure if at least one breast has failed. The treatment success by subject is 100% for both best and worst case analysis.||||
72529842|NCT02504424|144589499|OTHER||% breasts successfully exchanged|95.2|||||ONE_SIDED|||||||||Secondary analysis is repeated including all breasts in the PP cohort (including non-device related failures). The Treatment Success Rate by breast, based on the Per Protocol cohort, including all cause failures, is 95.2% (80/84). One subject (2 breasts) are not included in analysis as subject withdrew from the study prior to exchange of her expanders.||||
72529843|NCT00890396|144589500|SUPERIORITY|||||||0.67|||||||Fisher Exact|||The primary analysis compared the frequency of worsening spleen function (from normal to decreased or absent, or from decreased to absent).||||0.67
72529844|NCT00890396|144589501|SUPERIORITY||||||>|0.99|||||||Fisher Exact|||The primary analysis compared the frequency of worsening spleen function (from normal to decreased or absent, or from decreased to absent).||||>0.99
72529845|NCT00890396|144589502|SUPERIORITY|||||||0.61|||||||Kruskal-Wallis|||Kruskal-Wallis test was used to test if there were a statistically significant difference between the two treatment groups.||||0.61
72529846|NCT00890396|144589503|SUPERIORITY|||||||0.78|||||||Kruskal-Wallis|||Kruskal-Wallis test was used to test if there were a statistically significant difference between the two treatment groups.||||0.78
72529847|NCT00890396|144589504|SUPERIORITY|||||||0.8|||||||Kruskal-Wallis|||Kruskal-Wallis test was used to test if there were a statistically significant difference between the two treatment groups.||||0.80
72529848|NCT00890396|144589505|SUPERIORITY|||||||0.11|||||||Kruskal-Wallis|||Kruskal-Wallis test was used to test if there were a statistically significant difference between the two treatment groups.||||0.11
72529849|NCT00890396|144589506|SUPERIORITY|||||||0.85|||||||Kruskal-Wallis|||Kruskal-Wallis test was used to test if there were a statistically significant difference between the two treatment groups.||||0.85
72529850|NCT00890396|144589507|SUPERIORITY|||||||0.95|||||||Kruskal-Wallis|||Kruskal-Wallis test was used to test if there were a statistically significant difference between the two treatment groups.||||0.95
72529851|NCT00890396|144589508|SUPERIORITY|||||||0.4|||||||Kruskal-Wallis|||Kruskal-Wallis test was used to test if there were a statistically significant difference between the two treatment groups.||||0.40
72529852|NCT00890396|144589509|SUPERIORITY|||||||0.11|||||||Kruskal-Wallis|||Kruskal-Wallis test was used to test if there were a statistically significant difference between the two treatment groups.||||0.11
72529853|NCT00440232|144589510|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.969||||0.172|TWO_SIDED|95.0|0.74|5.235|||Chi-squared|||||5.235|0.74|0.172
72529854|NCT00440232|144589511|SUPERIORITY_OR_OTHER||log rank chi square|1.247||||0.264||95.0|||||Log Rank|df=1||||||0.264
72529855|NCT00362297|144589513|SUPERIORITY_OR_OTHER_LEGACY||Incident Risk Ratio|0.79||||0.052||95.0|0.63|1.0|||Regression, Poisson|Adjusted for period effects.||Comparison of genital HSV shedding rate on high dose acyclovir to standard dose valacyclovir. Powered with 80% chance of detecting 50% reduction in genital shedding rate on high dose acyclovir compared to standard dose valacyclovir.||1.00|0.63|0.052
72529856|NCT01259388|144589526|SUPERIORITY_OR_OTHER_LEGACY|||||||0.346|||||||t-test, 2 sided|||||||0.346
72529857|NCT01259388|144589528|SUPERIORITY_OR_OTHER_LEGACY|||||||0.013|||||||Wilcoxon (Mann-Whitney)|||||||0.013
72407878|NCT00094653|144324112|SUPERIORITY_OR_OTHER|||||||0.0433||95.0||||P-values were computed using CMH test stratified by baseline M-stage at randomization (M0, M1a, M1b vs. M1c) and prior IL-2 treatment (Yes vs. No).|Cochran-Mantel-Haenszel|||||||0.0433
72529858|NCT02743494|144589529|SUPERIORITY||Hazard Ratio (HR)|0.69||||0.0003|TWO_SIDED|96.4|0.56|0.86|||Stratified log-rank test||Stratified Cox proportional hazard model. Hazard Ratio is Nivolumab over Placebo.|||0.86|0.56|0.0003
72529859|NCT01078389|144589542|SUPERIORITY_OR_OTHER|||||||0.472|||||||Ranked Analysis of Covariance (ANCOVA)|Baseline modified Sharp/van der Heijde Erosion Score as a covariate.||Change from Baseline at Month 24||||0.472
72529860|NCT01078389|144589543|SUPERIORITY_OR_OTHER|||||||0.548|||||||Ranked ANCOVA|Baseline modified Sharp/van der Heijde Total Score from full hands and feet as a covariate.||Change from Baseline at Month 24||||0.548
72529861|NCT01078389|144589544|SUPERIORITY_OR_OTHER|||||||0.389|||||||Ranked ANCOVA|Baseline modified Sharp/van der Heijde Erosion Score from full hands and feet as a covariate.||Change from Baseline at Month 24||||0.389
72529862|NCT01078389|144589545|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Ranked ANCOVA|Baseline RAMRIS Synovitis Score as a covariate.||Synovitis: Change from Baseline at Month 24||||<0.001
72529863|NCT01078389|144589545|SUPERIORITY_OR_OTHER|||||||0.634|||||||Ranked ANCOVA|Baseline RAMRIS Erosion(Distal+Proximal) Score as a covariate.||Erosion(Distal+Proximal): Change from Baseline at Month 24||||0.634
72529864|NCT01078389|144589545|SUPERIORITY_OR_OTHER|||||||0.307|||||||Ranked ANCOVA|Baseline RAMRIS Edema(Distal+Proximal) Score as a covariate.||Edema(Distal+Proximal): Change from Baseline at Month 24||||0.307
72529865|NCT01078389|144589546|SUPERIORITY_OR_OTHER|||||||0.122|||||||Ranked ANCOVA|Baseline modified Sharp/van der Heijde Total Score as a covariate.||Change from Baseline at Month 24||||0.122
72529866|NCT02551874|144589547|NON_INFERIORITY|Noninferiority was defined by upper bound of 95% CI \<0.3%|Mean Difference (Final Values)|-0.13|STANDARD_ERROR_OF_MEAN|0.085||0.118|TWO_SIDED|95.0|-0.3|0.03||Superiority|Mixed Models Analysis|Adjusted for treatment, baseline HbA1c, randomization stratification factor, visit, treatment-by-visit, and baseline HbA1c-by-visit.||||0.03|-0.30|0.118
72529867|NCT02551874|144589548|SUPERIORITY||Mean Difference (Final Values)|-3.64|STANDARD_ERROR_OF_MEAN|0.282|<|0.001|TWO_SIDED|95.0|-4.2|-3.09|||Mixed Models Analysis|Adjusted for treatment, baseline body weight, randomization stratification factor, visit, treatment-by-visit, and baseline body weight-by-visit.||||-3.09|-4.20|<0.001
72529868|NCT02551874|144589549|SUPERIORITY||Odds Ratio (OR)|0.4|||<|0.001|TWO_SIDED|95.0|0.3|0.62|||Regression, Logistic|Adjusted for baseline HbA1c and randomization stratification factor (background medication of metformin with or without SU).||||0.62|0.30|<0.001
72529869|NCT02551874|144589550|SUPERIORITY||Odds Ratio (OR)|1.8||||0.008|TWO_SIDED|95.0|1.16|2.67|||Regression, Logistic|||||2.67|1.16|0.008
72529870|NCT02551874|144589551|NON_INFERIORITY|Noninferiority was defined by lower bound of 95% CI \>-10%.|Adjusted Percent Difference|-0.4|||||TWO_SIDED|95.0|-7.42|6.54||||||||6.54|-7.42|
72529871|NCT02551874|144589552|NON_INFERIORITY|Noninferiority was defined by upper bound of 95% CI \<12 mg/dL.|Mean Difference (Final Values)|-19.99|STANDARD_ERROR_OF_MEAN|3.55|<|0.0001|TWO_SIDED|95.0|-26.98|-13.0|||Mixed Models Analysis|Adjusted for treatment, baseline measurement, randomization stratification factor, visit, treatment-by-visit, and baseline-by-visit.||||-13.00|-26.98|<0.0001
72529872|NCT03938857|144589574|OTHER||Slope|-0.1088295|STANDARD_ERROR_OF_MEAN|0.4728041||0.814|TWO_SIDED|95.0|-1.035508|0.8178494|||Mixed Models Analysis||Estimated value represents interaction between treatment and days.|Placebo group compared to combined Dexmedetomidine groups.||0.8178494|-1.035508|0.814
72529873|NCT02577107|144589602|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|20.314|STANDARD_ERROR_OF_MEAN|4.1613|||TWO_SIDED|95.0|9.618|31.011||||||||31.011|9.618|
72529874|NCT02988115|144589620|SUPERIORITY||Least squares means difference|-21.41|STANDARD_ERROR_OF_MEAN|1.897|<|0.001|TWO_SIDED|95.0|-25.132|-17.697|||ANCOVA||bempedoic acid (BA) therapy minus placebo|||-17.697|-25.132|<0.001
72529875|NCT02988115|144589621|SUPERIORITY||Least squares means difference|-18.91|STANDARD_ERROR_OF_MEAN|2.063|<|0.001|TWO_SIDED|95.0|-22.951|-14.865|||ANCOVA||BA therapy minus placebo|||-14.865|-22.951|<0.001
72529876|NCT02988115|144589622|SUPERIORITY||Least squares means difference|-17.94|STANDARD_ERROR_OF_MEAN|1.597|<|0.001|TWO_SIDED|95.0|-21.07|-14.811|||ANCOVA||BA therapy minus placebo|non-HDL-C||-14.811|-21.070|<0.001
72529877|NCT02988115|144589622|SUPERIORITY||Least squares means difference|-14.76|STANDARD_ERROR_OF_MEAN|1.287|<|0.001|TWO_SIDED|95.0|-17.283|-12.239|||ANCOVA||BA therapy minus placebo|TC||-12.239|-17.283|<0.001
72529878|NCT02988115|144589622|SUPERIORITY||Least squares means difference|-14.96|STANDARD_ERROR_OF_MEAN|1.581|<|0.001|TWO_SIDED|95.0|-18.062|-11.866|||ANCOVA||BA therapy minus placebo|apoB||-11.866|-18.062|<0.001
72529879|NCT02988115|144589623|SUPERIORITY||Median treatment difference|-24.29|STANDARD_ERROR_OF_MEAN|-24.3|<|0.001|TWO_SIDED|95.0|-35.888|-12.712|||Wilcoxon rank sum test||BA therapy minus placebo|||-12.712|-35.888|<0.001
72529880|NCT01014442|144589639|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|1.305||||0.2649|TWO_SIDED|95.0|-0.83|4.25|||Wilcoxon rank sum test|||Cmax of MPA at Day 4. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||4.2500|-0.8300|0.2649
72529881|NCT01014442|144589639|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|11.405||||0.3113|TWO_SIDED|95.0|-10.2|42.78|||Wilcoxon rank sum test|||Cmax of MPAG at Day 4. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||42.7800|-10.2000|0.3113
72529882|NCT01014442|144589639|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-0.305||||0.2953|TWO_SIDED|95.0|-0.81|0.19|||Wilcoxon rank sum test|||Cmax of AcMPAG at Day 4. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.1900|-0.8100|0.2953
72529883|NCT01014442|144589640|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-1.29||||0.1308|TWO_SIDED|95.0|-2.99|0.41|||Wilcoxon rank sum test|||Cmax of MPA at Day 8. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.4100|-2.9900|0.1308
72529884|NCT01014442|144589640|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-10.845||||0.4886|TWO_SIDED|95.0|-31.5|20.79|||Wilcoxon rank sum test|||Cmax of MPAG at Day 8. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||20.7900|-31.5000|0.4886
72529885|NCT01014442|144589640|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-0.2||||0.2218|TWO_SIDED|95.0|-0.6|0.19|||Wilcoxon rank sum test|||Cmax of AcMPAG at Day 8. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.1900|-0.6000|0.2218
72529886|NCT01014442|144589641|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-1.87||||0.0886|TWO_SIDED|95.0|-3.79|0.28|||Wilcoxon rank sum test|||Cmax of MPA at Day 20. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.2800|-3.7900|0.0886
72529887|NCT01014442|144589641|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-30.76||||0.022|TWO_SIDED|95.0|-54.97|-6.36|||Wilcoxon rank sum test|||Cmax of MPAG at Day 20. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||-6.3600|-54.9700|0.0220
72529888|NCT01014442|144589641|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-0.56||||0.0008|TWO_SIDED|95.0|-1.02|-0.27|||Wilcoxon rank sum test|||Cmax of AcMPAG at Day 20. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||-0.2700|-1.0200|0.0008
72529889|NCT01014442|144589642|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|3.945||||0.0318|TWO_SIDED|95.0|0.25|8.23|||Wilcoxon rank sum test|||Cmax of MPA at Day 90. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||8.2300|0.2500|0.0318
72529890|NCT01014442|144589642|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-7.59||||0.7144|TWO_SIDED|95.0|-51.19|30.7|||Wilcoxon rank sum test|||Cmax of MPAG at Day 90. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||30.7000|-51.1900|0.7144
72529891|NCT01014442|144589642|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|0.27||||0.393|TWO_SIDED|95.0|-0.31|0.88|||Wilcoxon rank sum test|||Cmax of AcMPA at Day 90. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.8800|-0.3100|0.3930
72529892|NCT01014442|144589643|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|17.08||||0.3002|TWO_SIDED|95.0|-16.5|74.32|||Wilcoxon rank sum test|||Cmax of Free MPA at Day 4. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||74.3200|-16.5000|0.3002
72369171|NCT00494676|144248424|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.6|STANDARD_DEVIATION|2.6|=|0.09|TWO_SIDED|95.0|-0.1|1.3|||t-test, 2 sided|||Mobility improvement scores were normally distributed. A paired t-test was used to conduct a within-subjects comparison of the crossover differences in mobility scores between real and sham prism glasses. An alpha level of 5% was used to indicate statistical significance for secondary analyses||1.3|-0.1|= 0.09
72369172|NCT00494676|144248425|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.9|STANDARD_DEVIATION|2.7|=|0.002|TWO_SIDED|95.0|0.7|3.0|||t-test, 2 sided|||||3.0|0.7|= 0.002
72529893|NCT01014442|144589644|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-25.24||||0.0334|TWO_SIDED|95.0|-53.25|-2.29|||Wilcoxon rank sum test|||Cmax of Free MPA at Day 8. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||-2.2900|-53.2500|0.0334
72529894|NCT01014442|144589645|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-23.805||||0.1151|TWO_SIDED|95.0|-52.27|5.97|||Wilcoxon rank sum test|||Cmax of Free MPA at Day 20. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||5.9700|-52.2700|0.1151
72529895|NCT01014442|144589646|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-15.63||||0.5974|TWO_SIDED|95.0|-63.88|30.56|||Wilcoxon rank sum test|||Cmax of Free MPA at Day 90. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||30.5600|-63.8800|0.5974
72529896|NCT01014442|144589647|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|0.0005||||0.5466|TWO_SIDED|95.0|-0.00103|0.00259|||Wilcoxon rank sum test|||Dose-Normalized Cmax of MPA at Day 4. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.00259|-0.00103|0.5466
72529897|NCT01014442|144589647|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|0.00728||||0.3223|TWO_SIDED|95.0|-0.00707|0.03161|||Wilcoxon rank sum test|||Dose-Normalized Cmax of MPAG at Day 4. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.03161|-0.00707|0.3223
72529898|NCT01014442|144589647|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-0.00026||||0.2108|TWO_SIDED|95.0|-0.0007|0.00012|||Wilcoxon rank sum test|||Dose-Normalized Cmax of AcMPAG at Day 4. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.00012|-0.00070|0.2108
72529899|NCT01014442|144589647|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|0.0000112||||0.4334|TWO_SIDED|95.0|-0.000014|0.0000462|||Wilcoxon rank sum test|||Dose-Normalized Cmax of Free MPA at Day 4. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called a Hodges-Lehmann estimator.||0.0000462|-0.0000140|0.4334
72529900|NCT01014442|144589648|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-0.00081||||0.1511|TWO_SIDED|95.0|-0.00216|0.0003|||Wilcoxon rank sum test|||Dose-Normalized Cmax of MPA at Day 8. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.00030|-0.00216|0.1511
72529901|NCT01014442|144589648|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-0.00695||||0.4131|TWO_SIDED|95.0|-0.0205|0.01103|||Wilcoxon rank sum test|||Dose-Normalized Cmax of MPAG at Day 8. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.01103|-0.02050|0.4131
72529902|NCT01014442|144589648|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-0.00017||||0.2677|TWO_SIDED|95.0|-0.00046|0.00013|||Wilcoxon rank sum test|||Dose-Normalized Cmax of AcMPAG at Day 8. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.00013|-0.00046|0.2677
72529903|NCT01014442|144589648|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-0.0000185||||0.0173|TWO_SIDED|95.0|-0.0000394|-0.000005|||Wilcoxon rank sum test|||Dose-Normalized Cmax of Free MPA at Day 8. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||-0.0000050|-0.0000394|0.0173
72529904|NCT01014442|144589649|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-0.00063||||0.3784|TWO_SIDED|95.0|-0.0023|0.00084|||Wilcoxon rank sum test|||Dose-Normalized Cmax of MPA at Day 20. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.00084|-0.00230|0.3784
72529905|NCT01014442|144589649|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-0.01602||||0.0942|TWO_SIDED|95.0|-0.03229|0.00297|||Wilcoxon rank sum test|||Dose-Normalized Cmax of MPAG at Day 20. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.00297|-0.03229|0.0942
72529906|NCT01014442|144589649|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-0.00037||||0.0032|TWO_SIDED|95.0|-0.00062|-0.00015|||Wilcoxon rank sum test|||Dose-Normalized Cmax of AcMPAG at Day 20. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||-0.00015|-0.00062|0.0032
72529907|NCT01014442|144589649|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-0.0000126||||0.176|TWO_SIDED|95.0|-0.0000328|-0.0000091|||Wilcoxon rank sum test|||Dose-Normalized Cmax of Free MPA at Day 20. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||-0.0000091|-0.0000328|0.1760
72529908|NCT01014442|144589650|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|0.0043||||0.0509|TWO_SIDED|95.0|-0.00027|0.00833|||Wilcoxon rank sum test|||Dose-Normalized Cmax of MPA at Day 90. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.00833|-0.00027|0.0509
72529909|NCT01014442|144589650|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-0.00567||||0.8262|TWO_SIDED|95.0|-0.03414|0.02671|||Wilcoxon rank sum test|||Dose-Normalized Cmax of MPAG at Day 90. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.02671|-0.03414|0.8262
72529910|NCT01014442|144589650|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|0.00023||||0.4345|TWO_SIDED|95.0|-0.0003|0.0007|||Wilcoxon rank sum test|||Dose-Normalized Cmax of AcMPAG at Day 90. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.00070|-0.00030|0.4345
72529911|NCT01014442|144589650|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-0.00001||||0.6472|TWO_SIDED|95.0|-0.0000586|0.0000364|||Wilcoxon rank sum test|||Dose-Normalized Cmax of Free MPA at Day 90. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.0000364|-0.0000586|0.6472
72529912|NCT01014442|144589651|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-0.0333||||0.5745|TWO_SIDED|95.0|-1.95|0.5|||Wilcoxon rank sum test|||Tmax of MPA at Day 4. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.5000|-1.9500|0.5745
72529913|NCT01014442|144589651|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-1.8||||0.2003|TWO_SIDED|95.0|-2.3333|0.0833|||Wilcoxon rank sum test|||Tmax of MPAG at Day 4. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.0833|-2.3333|0.2003
72529914|NCT01014442|144589651|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-0.5||||0.0929|TWO_SIDED|95.0|-2.0833|0.0|||Wilcoxon rank sum test|||Tmax of AcMPA at Day 4. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.0000|-2.0833|0.0929
72529915|NCT01014442|144589651|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|0.0||||0.0823|TWO_SIDED|95.0|0.0|0.0667|||Wilcoxon rank sum test|||Tmax of Free MPA at Day 4. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.0667|0.0000|0.0823
72529916|NCT01014442|144589652|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|0.0417||||0.8106|TWO_SIDED|95.0|-0.5|1.7333|||Wilcoxon rank sum test|||Tmax of MPA at Day 8. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||1.7333|-0.5000|0.8106
72529917|NCT01014442|144589652|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|0.0||||1|TWO_SIDED|95.0|-0.1667|0.1667|||Wilcoxon rank sum test|||Tmax of MPAG at Day 8. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.1667|-0.1667|1.0000
72529918|NCT01014442|144589652|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|0.0667||||0.6311|TWO_SIDED|95.0|-0.3333|1.4667|||Wilcoxon rank sum test|||Tmax of AcMPAG at Day 8. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||1.4667|-0.3333|0.6311
72369173|NCT00494676|144248426|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5|STANDARD_DEVIATION|2.1|=|0.21|TWO_SIDED|95.0|-1.2|0.3|||t-test, 2 sided|||||0.3|-1.2|= 0.21
72529919|NCT01014442|144589652|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|0.0||||0.433|TWO_SIDED|95.0|-0.1667|0.0167|||Wilcoxon rank sum test|||Tmax of Free MPA at Day 8. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.0167|-0.1667|0.4330
72407879|NCT00094653|144324112|SUPERIORITY_OR_OTHER|||||||0.0012||95.0||||P-values were computed using CMH test stratified by baseline M-stage at randomization (M0, M1a, M1b vs. M1c) and prior IL-2 treatment (Yes vs. No).|Cochran-Mantel-Haenszel|||||||0.0012
72407880|NCT00094653|144324112|SUPERIORITY_OR_OTHER|||||||0.0402||95.0||||P-values were computed using CMH test stratified by baseline M-stage at randomization (M0, M1a, M1b vs. M1c) and prior IL-2 treatment (Yes vs. No).|Cochran-Mantel-Haenszel|||||||0.0402
72529920|NCT01014442|144589653|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|0.0||||1|TWO_SIDED|95.0|-1.1667|0.5833|||Wilcoxon rank sum test|||Tmax of MPA at Day 20. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.5833|-1.1667|1.0000
72529921|NCT01014442|144589653|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-0.0833||||0.4947|TWO_SIDED|95.0|-2.0|0.0833|||Wilcoxon rank sum test|||Tmax of MPAG at Day 20. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.0833|-2.0000|0.4947
72529922|NCT01014442|144589653|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-0.1667||||0.4425|TWO_SIDED|95.0|-1.9667|0.2|||Wilcoxon rank sum test|||Tmax of AcMPAG at Day 20. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.2000|-1.9667|0.4425
72529923|NCT01014442|144589653|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|0.0||||0.972|TWO_SIDED|95.0|-0.05|0.0333|||Wilcoxon rank sum test|||Tmax of Free MPA at Day 20. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.0333|-0.0500|0.9720
72529924|NCT01014442|144589654|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-0.0333||||0.8834|TWO_SIDED|95.0|-1.1667|0.7|||Wilcoxon rank sum test|||Tmax of MPA at Day 90. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.7000|-1.1667|0.8834
72529925|NCT01014442|144589654|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-1.8333||||0.0386|TWO_SIDED|95.0|-2.2|0.0|||Wilcoxon rank sum test|||Tmax of MPAG at Day 90. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.0000|-2.2000|0.0386
72529926|NCT01014442|144589654|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-0.525||||0.0558|TWO_SIDED|95.0|-2.6167|0.0|||Wilcoxon rank sum test|||Tmax of AcMPAG at Day 90. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.0000|-2.6167|0.0558
72529927|NCT01014442|144589654|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-0.15||||0.0082|TWO_SIDED|95.0|-0.2333|-0.0667|||Wilcoxon rank sum test|||Tmax of Free MPA at Day 90. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||-0.0667|-0.2333|0.0082
72529928|NCT01014442|144589655|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|0.13||||0.5224|TWO_SIDED|95.0|-0.26|0.5|||Wilcoxon rank sum test|||Cmin of MPA at Day 4. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.5000|-0.2600|0.5224
72529929|NCT01014442|144589655|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|11.16||||0.2088|TWO_SIDED|95.0|-5.29|30.29|||Wilcoxon rank sum test|||Cmin of MPAG at Day 4. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||30.2900|-5.2900|0.2088
72529930|NCT01014442|144589655|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-0.165||||0.1794|TWO_SIDED|95.0|-0.45|0.08|||Wilcoxon rank sum test|||Cmin of AcMPAG at Day 4. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.0800|-0.4500|0.1794
72529931|NCT01014442|144589656|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-0.125||||0.4027|TWO_SIDED|95.0|-0.38|0.19|||Wilcoxon rank sum test|||Cmin of MPA at Day 8. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.1900|-0.3800|0.4027
72625627|NCT04604431|144780615|SUPERIORITY||Odds Ratio (OR)|14.1|||<|0.001|TWO_SIDED|95.0|6.9|29.1|||Mixed Models Analysis|||Odds ratios will be computed to describe the odds of adherence for the iREACH intervention compared to the control intervention for low-risk infants.||29.1|6.9|<0.001
72625628|NCT04604431|144780615|SUPERIORITY||Odds Ratio (OR)|3.1||||0.034|TWO_SIDED|95.0|1.1|8.8|||Mixed Models Analysis|||Odds ratios will be computed to describe the odds of adherence for the iREACH intervention compared to the control intervention for high-risk infants.||8.8|1.1|0.034
72625629|NCT04603560|144780620|SUPERIORITY||Odds Ratio (OR)|0.95|||||TWO_SIDED|95.0|0.54|1.66|||||The odds ratio represents Social Norming vs Control.|Generalized estimating equation adjusting for clustering of patients within providers as well as provider panel size||1.66|0.54|
72407881|NCT00094653|144324115|SUPERIORITY_OR_OTHER|||||||0.0179||95.0||||P-values were computed using CMH test stratified by baseline M-stage at randomization (M0, M1a, M1b vs. M1c) and prior IL-2 treatment (Yes vs. No).|Cochran-Mantel-Haenszel|||||||0.0179
72625630|NCT04603560|144780620|SUPERIORITY||Odds Ratio (OR)|1.28|||||TWO_SIDED|95.0|0.72|2.29|||||The odds ratio represents Pharmacist E-Detailing vs Control.|Generalized estimating equation adjusting for clustering of patients within providers as well as provider panel size||2.29|0.72|
72529932|NCT01014442|144589656|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-16.09||||0.0875|TWO_SIDED|95.0|-29.35|6.39|||Wilcoxon rank sum test|||Cmin of MPAG at Day 8. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||6.3900|-29.3500|0.0875
72529933|NCT01014442|144589656|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-0.2||||0.0112|TWO_SIDED|95.0|-0.35|-0.05|||Wilcoxon rank sum test|||Cmin of AcMPAG at Day 8. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||-0.0500|-0.3500|0.0112
72529934|NCT01014442|144589657|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-0.215||||0.0818|TWO_SIDED|95.0|-0.56|0.05|||Wilcoxon rank sum test|||Cmin of MPA at Day 20. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.0500|-0.5600|0.0818
72529935|NCT01014442|144589657|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-14.03||||0.0945|TWO_SIDED|95.0|-26.9|2.94|||Wilcoxon rank sum test|||Cmin of MPAG at Day 20. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||2.9400|-26.9000|0.0945
72571919|NCT02912650|144671808|SUPERIORITY_OR_OTHER||LS Mean Difference|2.15|||<|0.001|TWO_SIDED|95.0|1.52|2.79|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||2.79|1.52|<0.001
72571920|NCT02912650|144671808|SUPERIORITY_OR_OTHER||LS Mean Difference|0.74||||0.001|TWO_SIDED|95.0|0.3|1.19|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.19|0.30|0.001
72571921|NCT02912650|144671808|SUPERIORITY_OR_OTHER||LS Mean Difference|3.44|||<|0.001|TWO_SIDED|95.0|2.79|4.09|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||4.09|2.79|<0.001
72529936|NCT01014442|144589657|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-0.19||||0.0081|TWO_SIDED|95.0|-0.41|-0.04|||Wilcoxon rank sum test|||Cmin of AcMPAG at Day 20. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||-0.0400|-0.4100|0.0081
72529937|NCT01014442|144589658|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-0.36||||0.3289|TWO_SIDED|95.0|-1.14|0.28|||Wilcoxon rank sum test|||Cmin of MPA at Day 90. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.2800|-1.1400|0.3289
72529938|NCT01014442|144589658|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-20.3||||0.1243|TWO_SIDED|95.0|-49.39|4.71|||Wilcoxon rank sum test|||Cmin of MPAG at Day 90. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||4.7100|-49.3900|0.1243
72529939|NCT01014442|144589658|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-0.03||||0.8704|TWO_SIDED|95.0|-0.28|0.23|||Wilcoxon rank sum test|||Cmin of AcMPAG at Day 90. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.2300|-0.2800|0.8704
72571922|NCT02912650|144671808|SUPERIORITY_OR_OTHER||LS Mean Difference|0.7||||0.003|TWO_SIDED|95.0|0.24|1.15|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.15|0.24|0.003
72571923|NCT02912650|144671808|SUPERIORITY_OR_OTHER||LS Mean Difference|1.85|||<|0.001|TWO_SIDED|95.0|1.39|2.31|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||2.31|1.39|<0.001
72571924|NCT02912650|144671808|SUPERIORITY_OR_OTHER||LS Mean Difference|2.74|||<|0.001|TWO_SIDED|95.0|2.1|3.39|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||3.39|2.10|<0.001
72571925|NCT02912650|144671808|SUPERIORITY_OR_OTHER||LS Mean Difference|1.59|||<|0.001|TWO_SIDED|95.0|0.94|2.24|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||2.24|0.94|< 0.001
72571926|NCT02912650|144671808|SUPERIORITY_OR_OTHER||LS Mean Difference|1.15|||<|0.001|TWO_SIDED|95.0|0.69|1.61|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.61|0.69|<0.001
72571927|NCT02912650|144671808|SUPERIORITY_OR_OTHER||LS Mean Difference|3.33|||<|0.001|TWO_SIDED|95.0|2.67|4.0|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||4.00|2.67|<0.001
72571928|NCT02912650|144671808|SUPERIORITY_OR_OTHER||LS Mean Difference|0.74||||0.002|TWO_SIDED|95.0|0.27|1.2|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.20|0.27|0.002
72571929|NCT02912650|144671808|SUPERIORITY_OR_OTHER||LS Mean Difference|1.94|||<|0.001|TWO_SIDED|95.0|1.47|2.41|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||2.41|1.47|<0.001
72571930|NCT02912650|144671808|SUPERIORITY_OR_OTHER||LS Mean Difference|2.6|||<|0.001|TWO_SIDED|95.0|1.93|3.26|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||3.26|1.93|<0.001
72571931|NCT02912650|144671808|SUPERIORITY_OR_OTHER||LS Mean Difference|1.4|||<|0.001|TWO_SIDED|95.0|0.73|2.07|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||2.07|0.73|<0.001
72571932|NCT02912650|144671808|SUPERIORITY_OR_OTHER||LS Mean Difference|1.2|||<|0.001|TWO_SIDED|95.0|0.73|1.67|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.67|0.73|<0.001
72407882|NCT00094653|144324115|SUPERIORITY_OR_OTHER|||||||0.0002||95.0||||P-values were computed using CMH test stratified by baseline M-stage at randomization (M0, M1a, M1b vs. M1c) and prior IL-2 treatment (Yes vs. No).|Cochran-Mantel-Haenszel|||||||0.0002
72529940|NCT01014442|144589659|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|5.22||||0.4043|TWO_SIDED|95.0|-5.01|24.49|||Wilcoxon rank sum test|||Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||24.4900|-5.0100|0.4043
72529941|NCT01014442|144589660|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-0.44||||0.893|TWO_SIDED|95.0|-6.07|8.01|||Wilcoxon rank sum test|||Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||8.0100|-6.0700|0.8930
72529942|NCT01014442|144589661|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-4.935||||0.0819|TWO_SIDED|95.0|-14.31|1.11|||Wilcoxon rank sum test|||Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||1.1100|-14.3100|0.0819
72529943|NCT01014442|144589662|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-8.205||||0.0414|TWO_SIDED|95.0|-19.27|-0.07|||Wilcoxon rank sum test|||Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||-0.0700|-19.2700|0.0414
72529944|NCT01014442|144589663|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|69.7186||||0.1552|TWO_SIDED|95.0|-23.4659|162.9545|||Wilcoxon rank sum test|||Vz of MPA at Day 4. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||162.9545|-23.4659|0.1552
72529945|NCT01014442|144589663|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-0.7836||||0.6057|TWO_SIDED|95.0|-3.2675|2.5529|||Wilcoxon rank sum test|||Vz of MPAG at Day 4. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||2.5529|-3.2675|0.6057
72529946|NCT01014442|144589663|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|299.1021||||0.0188|TWO_SIDED|95.0|79.5869|695.1789|||Wilcoxon rank sum test|||Vz of AcMPAG at Day 4. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||695.1789|79.5869|0.0188
72407883|NCT00094653|144324115|SUPERIORITY_OR_OTHER|||||||0.0429||95.0||||P-values were computed using CMH test stratified by baseline M-stage at randomization (M0, M1a, M1b vs. M1c) and prior IL-2 treatment (Yes vs. No).|Cochran-Mantel-Haenszel|||||||0.0429
72529947|NCT01014442|144589664|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|88.959||||0.0659|TWO_SIDED|95.0|-5.7876|209.0183|||Wilcoxon rank sum test|||Vz of MPA at Day 8. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||209.0183|-5.7876|0.0659
72529948|NCT01014442|144589664|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-0.4456||||0.7842|TWO_SIDED|95.0|-3.1366|2.292|||Wilcoxon rank sum test|||Vz of MPAG at Day 8. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||2.2920|-3.1366|0.7842
72529949|NCT01014442|144589664|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|121.3737||||0.4072|TWO_SIDED|95.0|-233.6483|560.0069|||Wilcoxon rank sum test|||Vz of AcMPAG at Day 8. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||560.0069|-233.6483|0.4072
72529950|NCT01014442|144589665|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|207.9933||||0.004|TWO_SIDED|95.0|71.2442|355.1739|||Wilcoxon rank sum test|||Vz of MPA at Day 20. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||355.1739|71.2442|0.0040
72529951|NCT01014442|144589665|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|2.6186||||0.0689|TWO_SIDED|95.0|-0.1999|6.7766|||Wilcoxon rank sum test|||Vz of MPAG at Day 20. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||6.7766|-0.1999|0.0689
72571933|NCT02912650|144671808|SUPERIORITY_OR_OTHER||LS Mean Difference|3.19|||<|0.001|TWO_SIDED|95.0|2.51|3.87|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||3.87|2.51|<0.001
72407884|NCT00094653|144324117|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.0||||0.2805|TWO_SIDED|95.0|-2.5|8.6|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Global quality of life change from baseline||8.6|-2.5|0.2805
72407885|NCT00094653|144324117|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.6||||0.63|TWO_SIDED|95.0|-5.0|8.2|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Global quality of life change from baseline||8.2|-5.0|0.6300
72571934|NCT02912650|144671808|SUPERIORITY_OR_OTHER||LS Mean Difference|0.76||||0.002|TWO_SIDED|95.0|0.29|1.23|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.23|0.29|0.002
72571935|NCT02912650|144671808|SUPERIORITY_OR_OTHER||LS Mean Difference|1.85|||<|0.001|TWO_SIDED|95.0|1.37|2.33|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||2.33|1.37|< 0.001
72407886|NCT00094653|144324117|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.4||||0.6026|TWO_SIDED|95.0|-3.9|6.8|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Global quality of life change from baseline||6.8|-3.9|0.6026
72407887|NCT00094653|144324117|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.9||||0.1219|TWO_SIDED|95.0|-1.1|8.9|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Physical change from baseline||8.9|-1.1|0.1219
72407888|NCT00094653|144324117|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.0||||0.0978|TWO_SIDED|95.0|-0.9|11.0|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Physical change from baseline||11.0|-0.9|0.0978
72407889|NCT00094653|144324117|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.1||||0.659|TWO_SIDED|95.0|-6.0|3.8|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Physical change from baseline||3.8|-6.0|0.6590
72407890|NCT00094653|144324117|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.3||||0.248|TWO_SIDED|95.0|-3.0|11.7|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Role change, change from baseline||11.7|-3.0|0.2480
72407891|NCT00094653|144324117|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.2||||0.4742|TWO_SIDED|95.0|-5.6|12.0|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Role change, change from baseline||12.0|-5.6|0.4742
72407892|NCT00094653|144324117|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.1||||0.7597|TWO_SIDED|95.0|-6.1|8.3|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Role change, change from baseline||8.3|-6.1|0.7597
72407893|NCT00094653|144324117|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3||||0.9119|TWO_SIDED|95.0|-4.7|5.2|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Cognitive change from baseline||5.2|-4.7|0.9119
72407894|NCT00094653|144324117|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9||||0.7616|TWO_SIDED|95.0|-6.9|5.0|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Cognitive change from baseline||5.0|-6.9|0.7616
72407895|NCT00094653|144324117|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.2||||0.6266|TWO_SIDED|95.0|-3.6|6.0|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Cognitive change from baseline||6.0|-3.6|0.6266
72407896|NCT00094653|144324117|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.9984|TWO_SIDED|95.0|-4.8|4.8|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Emotional change from baseline||4.8|-4.8|0.9984
72407897|NCT00094653|144324117|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.0||||0.4873|TWO_SIDED|95.0|-7.8|3.7|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Emotional change from baseline||3.7|-7.8|0.4873
72529952|NCT01014442|144589665|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|635.7812||||0.0306|TWO_SIDED|95.0|49.4696|2793.7642|||Wilcoxon rank sum test|||Vz of AcMPAG at Day 20. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||2793.7642|49.4696|0.0306
72407898|NCT00094653|144324117|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.0||||0.3938|TWO_SIDED|95.0|-2.7|6.7|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Emotional change from baseline||6.7|-2.7|0.3938
72407899|NCT00094653|144324117|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.4||||0.6695|TWO_SIDED|95.0|-8.1|5.2|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Social change from baseline||5.2|-8.1|0.6695
72529953|NCT01014442|144589666|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|4.7477||||0.9029|TWO_SIDED|95.0|-73.5212|59.8304|||Wilcoxon rank sum test|||Vz of MPA at Day 90. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||59.8304|-73.5212|0.9029
72529954|NCT01014442|144589666|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|0.0077||||0.9692|TWO_SIDED|95.0|-3.6739|3.9521|||Wilcoxon rank sum test|||Vz of MPAG at Day 90. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||3.9521|-3.6739|0.9692
72529955|NCT01014442|144589666|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-149.7962||||0.3744|TWO_SIDED|95.0|-644.4526|311.9735|||Wilcoxon rank sum test|||Vz of AcMPAG at Day 90. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||311.9735|-644.4526|0.3744
72529956|NCT01014442|144589667|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|7.8422||||0.1362|TWO_SIDED|95.0|-3.911|18.4444|||Wilcoxon rank sum test|||CL of MPA at Day 4. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||18.4444|-3.9110|0.1362
72529957|NCT01014442|144589667|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-0.1609||||0.4325|TWO_SIDED|95.0|-0.5693|0.271|||Wilcoxon rank sum test|||CL of MPAG at Day 4. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.2710|-0.5693|0.4325
72571936|NCT02912650|144671808|SUPERIORITY_OR_OTHER||LS Mean Difference|2.43|||<|0.001|TWO_SIDED|95.0|1.75|3.11|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||3.11|1.75|<0.001
72529958|NCT01014442|144589667|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|47.2686||||0.0316|TWO_SIDED|95.0|4.197|112.7806|||Wilcoxon rank sum test|||CL of AcMPAG at Day 4. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||112.7806|4.1970|0.0316
72529959|NCT01014442|144589668|SUPERIORITY_OR_OTHER||Hodges-Lehmann estmator|19.0536||||0.0572|TWO_SIDED|95.0|-0.425|35.3852|||Wilcoxon rank sum test|||CL of MPA at Day 8. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||35.3852|-0.4250|0.0572
72529960|NCT01014442|144589668|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|0.3541||||0.3198|TWO_SIDED|95.0|-0.2524|1.1097|||Wilcoxon rank sum test|||CL of MPAG at Day 8. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||1.1097|-0.2524|0.3198
72625631|NCT04603560|144780620|SUPERIORITY||Odds Ratio (OR)|1.38|||||TWO_SIDED|95.0|0.74|2.56|||||The odds ratio represents Pharmacist e-detailing vs Social Norming.|Generalized estimating equation adjusting for clustering of patients within providers as well as provider panel size.||2.56|0.74|
72529961|NCT01014442|144589668|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|54.0322||||0.0845|TWO_SIDED|95.0|-6.7706|160.3469|||Wilcoxon rank sum test|||CL of AcMPAG at Day 8. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||160.3469|-6.7706|0.0845
72529962|NCT01014442|144589669|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|25.0037||||0.0048|TWO_SIDED|95.0|8.2373|43.5102|||Wilcoxon rank sum test|||CL of MPA at Day 20. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||43.5102|8.2373|0.0048
72529963|NCT01014442|144589669|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|0.4297||||0.0277|TWO_SIDED|95.0|0.034|0.9925|||Wilcoxon rank sum test|||CL of MPAG at Day 20. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.9925|0.0340|0.0277
72529964|NCT01014442|144589669|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|318.5455||||0.0002|TWO_SIDED|95.0|154.1902|526.1716|||Wilcoxon rank sum test|||CL of AcMPAG at Day 20. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||526.1716|154.1902|0.0002
72529965|NCT01014442|144589670|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-0.579||||0.9417|TWO_SIDED|95.0|-14.5052|11.6346|||Wilcoxon rank sum test|||CL of MPA at Day 90. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||11.6346|-14.5052|0.9417
72529966|NCT01014442|144589670|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|0.1817||||0.2941|TWO_SIDED|95.0|-0.1954|0.6246|||Wilcoxon rank sum test|||CL of MPAG at Day 90. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.6246|-0.1954|0.2941
72529967|NCT01014442|144589670|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-4.9076||||0.817|TWO_SIDED|95.0|-84.8234|109.9321|||Wilcoxon rank sum test|||CL of AcMPAG at Day 90. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||109.9321|-84.8234|0.8170
72571937|NCT02912650|144671808|SUPERIORITY_OR_OTHER||LS Mean Difference|1.34|||<|0.001|TWO_SIDED|95.0|0.66|2.03|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||2.03|0.66|<0.001
72571938|NCT02912650|144671808|SUPERIORITY_OR_OTHER||LS Mean Difference|1.09|||<|0.001|TWO_SIDED|95.0|0.61|1.56|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.56|0.61|<0.001
72571939|NCT02912650|144671808|SUPERIORITY_OR_OTHER||LS Mean Difference|2.65|||<|0.001|TWO_SIDED|95.0|1.95|3.35|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||3.35|1.95|<0.001
72625632|NCT00643279|144780621|SUPERIORITY|Survival estimate at 6-months|6-month survival rate|91.5|||||ONE_SIDED|95.0|88.7||||||||||88.7|
72625633|NCT00643279|144780622|SUPERIORITY|Survival estimate at 6-months|6-month survival rate|100.0|||||ONE_SIDED|95.0|98.9||||||||||98.9|
72529968|NCT01014442|144589671|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-2.4102||||0.2798|TWO_SIDED|95.0|-8.5642|3.0044|||Wilcoxon rank sum test|||AUC0-12 of MPA at Day 4. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||3.0044|-8.5642|0.2798
72529969|NCT01014442|144589671|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|72.7203||||0.4063|TWO_SIDED|95.0|-107.1596|393.5295|||Wilcoxon rank sum test|||AUC0-12 of MPAG at Day 4. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||393.5295|-107.1596|0.4063
72625634|NCT05715827|144780630|OTHER|The study used descriptive statistics and 95% confidence intervals to summarize data. The sample size of 40 patients (20 per surgery type) was based on prior studies with 3% device malfunction and 0.9% failure-related conversion rates. The primary endpoint was the completion rate, defined as ≥95% without conversion due to system issues or major complications within 24 hours. The Full Analysis Set included all subjects who started the procedure. No interim analyses were planned.|Completion rate|97.5|||||TWO_SIDED|95.0|86.8|99.9||The study used descriptive statistics and confidence intervals, not hypothesis testing with p-values. The main goal was to confirm the completion rate met or exceeded 95% and present a 95% confidence interval||The main goal was to confirm the completion rate met or exceeded 95% with a 95% confidence interval.|Estimated Value of 97.5% is an overall completion rate|The study aimed to confirm the Medtronic Hugo™ RAS System's performance for prostatectomy or cholecystectomy, targeting a 95% completion rate (no conversion due to system issues or major complications within 24 hours). The Full Analysis Set (FAS) included all subjects starting the procedure. Descriptive statistics and 95% confidence intervals were used to assess primary and secondary endpoints, confirming safety and effectiveness.|Descriptive Analysis was used|99.9|86.8|
72369174|NCT02904954|144248437|SUPERIORITY||Risk Difference (RD)|46.6||||0.0001|TWO_SIDED|95.0|26.7|66.6||Testing at alpha = 0.05.|Fisher Exact|||Fisher's exact test performed to compare the MPR proportion between the two treatment arms. Null hypothesis is that there is no difference in the MPR proportion between the two arms.||66.6|26.7|0.0001
72529970|NCT01014442|144589671|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-3.6042||||0.0441|TWO_SIDED|95.0|-8.1854|-0.1887|||Wilcoxon rank sum test|||AUC0-12 of AcMPAG at Day 4. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||-0.1887|-8.1854|0.0441
72529971|NCT01014442|144589672|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-5.8077||||0.051|TWO_SIDED|95.0|-11.7302|0.0033|||Wilcoxon rank sum test|||AUC0-12 of MPA at Day 8. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.0033|-11.7302|0.0510
72369175|NCT02904954|144248438|SUPERIORITY|||||||0.89|||||||Log Rank|||Kaplan-Meier survival analysis comparing the two arms.||||0.89
72369176|NCT02904954|144248439|SUPERIORITY||Risk Difference (RD)|43.4||||0.0001|TWO_SIDED|95.0|24.4|62.3||Testing at alpha = 0.05.|Fisher Exact|||Fisher's exact test performed to compare the objective clinical response proportion between the two treatment arms. Null hypothesis is that there is no difference in the objective clinical response proportion between the two arms. Objective clinical response proportion is defined as the proportion of patients in each arm who have complete response or partial response.||62.3|24.4|0.0001
72369177|NCT01317277|144248448|SUPERIORITY|||||||0.68||||||In between-group analyses, overall MEMS adherence was defined as % of doses taken.|Wilcoxon (Mann-Whitney)|Non-parametric methods.||Randomization strategy for target 75 participants of 2:1 \[iTAB(n=50):CTRL(n=25)\], resulting in 80% power to detect effect size of .71 for difference of adherence rates between groups (Wilcoxon-Mann-Whitney critical t=1.99, df=69.6). Final # analyzed: iTAB (n=43) \& CTRL (n=23).||||0.68
72369178|NCT01317277|144248449|SUPERIORITY|||||||0.95||||||MEMS adherence based on dose timing was examined for between-group differences.|Wilcoxon (Mann-Whitney)|Non-parametric methods||Randomization strategy for target 75 participants of 2:1 \[iTAB(n=50):CTRL(n=25)\], resulting in 80% power to detect effect size of .71 for difference of adherence rates between groups (Wilcoxon-Mann-Whitney critical t=1.99, df=69.6). Final # analyzed: iTAB (n=43) \& CTRL (n=23).||||0.95
72369179|NCT01317277|144248450|SUPERIORITY|||||||0.05||||||Z = -1.97|Wilcoxon (Mann-Whitney)|Non-parametric methods; P-Value is calculated.||Text-reported METH use days||||0.05
72369180|NCT00912795|144248458|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|2.0|||||TWO_SIDED|95.0|0.62|6.3||||||||6.3|0.62|
72369181|NCT00912795|144248459|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.3|||||TWO_SIDED|95.0|0.5|3.2||||||||3.2|0.50|
72369182|NCT00912795|144248460|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|2.5|||||TWO_SIDED|95.0|0.81|7.5||||||||7.5|0.81|
72369183|NCT00912795|144248461|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|2.0|||||TWO_SIDED|95.0|0.62|6.3||||||||6.3|.62|
72369184|NCT01301027|144248501|SUPERIORITY_OR_OTHER|||||||0.047|||||||t-test, 2 sided|||||||0.047
72369185|NCT01301027|144248502|SUPERIORITY_OR_OTHER|||||||0.059|||||||t-test, 2 sided|||||||0.059
72369186|NCT01301027|144248503|SUPERIORITY_OR_OTHER|||||||0.508|||||||t-test, 2 sided|||||||0.508
72369187|NCT01301027|144248504|SUPERIORITY_OR_OTHER|||||||0.984|||||||t-test, 2 sided|||||||0.984
72369188|NCT02023697|144248506|OTHER||Hazard Ratio (HR)|1.057||||0.7047|TWO_SIDED|80.0|0.878|1.272|||Log Rank||Arm B / Arm (A+C)|||1.272|0.878|0.7047
72369189|NCT02023697|144248508|OTHER||Hazard Ratio (HR)|1.26||||0.3134|TWO_SIDED|80.0|0.939|1.69|||Log Rank||Arm C /Arm A|||1.690|0.939|0.3134
72369190|NCT02023697|144248512|OTHER||Hazard Ratio (HR)|1.075||||0.6205|TWO_SIDED|80.0|0.892|1.297|||Log Rank||Arm B/Arm (A+C)|||1.297|0.892|0.6205
72369191|NCT02023697|144248514|OTHER||Hazard Ratio (HR)|0.999||||0.9958|TWO_SIDED|80.0|0.744|1.341|||Log Rank||Arm C/Arm A|||1.341|0.744|0.9958
72369192|NCT02023697|144248518|OTHER||Hazard Ratio (HR)|1.068||||0.7461|TWO_SIDED|80.0|0.823|1.385|||Log Rank||Arm B/Arm (A+C)|||1.385|0.823|0.7461
72407900|NCT00094653|144324117|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.4||||0.4041|TWO_SIDED|95.0|-11.3|4.6|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Social change from baseline||4.6|-11.3|0.4041
72407901|NCT00094653|144324117|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.9||||0.5538|TWO_SIDED|95.0|-4.5|8.3|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Social change from baseline||8.3|-4.5|0.5538
72407902|NCT00094653|144324117|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.9||||0.2259|TWO_SIDED|95.0|-10.3|2.4|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Fatigue change from baseline||2.4|-10.3|0.2259
72407903|NCT00094653|144324117|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.0||||0.6168|TWO_SIDED|95.0|-9.6|5.7|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Fatigue change from baseline||5.7|-9.6|0.6168
72407904|NCT00094653|144324117|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.0||||0.5329|TWO_SIDED|95.0|-8.2|4.3|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Fatigue change from baseline||4.3|-8.2|0.5329
72407905|NCT00094653|144324117|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2||||0.9397|TWO_SIDED|95.0|-4.7|5.0|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Nausea and Vomiting change from baseline||5.0|-4.7|0.9397
72407906|NCT00094653|144324117|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.3||||0.6716|TWO_SIDED|95.0|-7.1|4.6|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Nausea and Vomiting change from baseline||4.6|-7.1|0.6716
72407907|NCT00094653|144324117|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.4||||0.5497|TWO_SIDED|95.0|-3.3|6.2|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Nausea and Vomiting change from baseline||6.2|-3.3|0.5497
72407908|NCT00094653|144324117|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.3||||0.0625|TWO_SIDED|95.0|-12.8|0.3|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Pain change from baseline||0.3|-12.8|0.0625
72407909|NCT00094653|144324117|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.0||||0.3214|TWO_SIDED|95.0|-11.9|3.9|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Pain change from baseline||3.9|-11.9|0.3214
72407910|NCT00094653|144324117|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.3||||0.4898|TWO_SIDED|95.0|-8.7|4.2|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Pain change from baseline||4.2|-8.7|0.4898
72407911|NCT00094653|144324117|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.6||||0.0761|TWO_SIDED|95.0|-11.8|0.6|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Dyspnea change from baseline||0.6|-11.8|0.0761
72529972|NCT01014442|144589672|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-171.159||||0.2733|TWO_SIDED|95.0|-361.4437|171.9652|||Wilcoxon rank sum test|||AUC0-12 of MPAG at Day 8. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||171.9652|-361.4437|0.2733
72407912|NCT00094653|144324117|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.8||||0.3187|TWO_SIDED|95.0|-11.2|3.7|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Dyspnea change from baseline||3.7|-11.2|0.3187
72407913|NCT00094653|144324117|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.8||||0.5548|TWO_SIDED|95.0|-7.9|4.2|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Dyspnea change from baseline||4.2|-7.9|0.5548
72529973|NCT01014442|144589672|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-1.9621||||0.0718|TWO_SIDED|95.0|-4.8456|0.2067|||Wilcoxon rank sum test|||AUC0-12 of AcMPAG at Day 8. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.2067|-4.8456|0.0718
72529974|NCT01014442|144589673|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-8.6964||||0.0002|TWO_SIDED|95.0|-13.7713|-4.6498|||Wilcoxon rank sum test|||AUC0-12 of MPA at Day 20. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||-4.6498|-13.7713|0.0002
72529975|NCT01014442|144589673|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-268.9537||||0.0058|TWO_SIDED|95.0|-506.7782|-77.397|||Wilcoxon rank sum test|||AUC0-12 of MPAG at Day 20. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||-77.3970|-506.7782|0.0058
72529976|NCT01014442|144589673|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-4.828|||<|0.0001|TWO_SIDED|95.0|-7.1455|-2.6133|||Wilcoxon rank sum test|||AUC0-12 of AcMPAG at Day 20. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||-2.6133|-7.1455|<0.0001
72529977|NCT01014442|144589674|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|1.7477||||0.7144|TWO_SIDED|95.0|-12.101|14.6563|||Wilcoxon rank sum test|||AUC0-12 of MPA at Day 90. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||14.6563|-12.1010|0.7144
72529978|NCT01014442|144589674|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-156.3255||||0.3413|TWO_SIDED|95.0|-526.0765|195.8348|||Wilcoxon rank sum test|||AUC0-12 of MPAG at Day 90. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||195.8348|-526.0765|0.3413
72529979|NCT01014442|144589674|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|0.888||||0.6251|TWO_SIDED|95.0|-3.0288|4.2273|||Wilcoxon rank sum test|||AUC0-12 of AcMPAG at Day 90. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||4.2273|-3.0288|0.6251
72529980|NCT01014442|144589675|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|24.315||||0.2342|TWO_SIDED|95.0|-16.0292|79.365|||Wilcoxon rank sum test|||Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||79.3650|-16.0292|0.2342
72407914|NCT00094653|144324117|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.5||||0.245|TWO_SIDED|95.0|-12.1|3.1|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Sleep disturbance change from baseline||3.1|-12.1|0.2450
72407915|NCT00094653|144324117|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9||||0.8464|TWO_SIDED|95.0|-10.0|8.2|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Sleep disturbance change from baseline||8.2|-10.0|0.8464
72529981|NCT01014442|144589676|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-13.5592||||0.1964|TWO_SIDED|95.0|-37.395|5.4825|||Wilcoxon rank sum test|||Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||5.4825|-37.3950|0.1964
72529982|NCT01014442|144589677|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-22.7878||||0.0672|TWO_SIDED|95.0|-44.8217|3.7573|||Wilcoxon rank sum test|||Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||3.7573|-44.8217|0.0672
72529983|NCT01014442|144589678|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-21.4737||||0.2453|TWO_SIDED|95.0|-64.1567|8.5708|||Wilcoxon rank sum test|||Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||8.5708|-64.1567|0.2453
72529984|NCT01014442|144589679|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-0.00237||||0.1362|TWO_SIDED|95.0|-0.00734|0.00106|||Wilcoxon rank sum test|||Dose-Normalized AUC0-12 of MPA at Day 4. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.00106|-0.00734|0.1362
72529985|NCT01014442|144589679|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|0.04797||||0.4325|TWO_SIDED|95.0|-0.08467|0.26322|||Wilcoxon rank sum test|||Dose-Normalized AUC0-12 MPAG at Day 4. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.26322|-0.08467|0.4325
72529986|NCT01014442|144589679|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-0.00311||||0.0316|TWO_SIDED|95.0|-0.00645|-0.00029|||Wilcoxon rank sum test|||Dose-Normalized AUC0-12 of AcMPAG at Day 4. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||-0.00029|-0.00645|0.0316
72529987|NCT01014442|144589679|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|0.0000158||||0.3269|TWO_SIDED|95.0|-0.0000134|0.0000552|||Wilcoxon rank sum test|||Dose-Normalized AUC0-12 of Free MPA at Day 4. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.0000552|-0.0000134|0.3269
72571940|NCT02912650|144671808|SUPERIORITY_OR_OTHER||LS Mean Difference|0.61||||0.015|TWO_SIDED|95.0|0.12|1.09|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.09|0.12|0.015
72571941|NCT02912650|144671808|SUPERIORITY_OR_OTHER||LS Mean Difference|1.73|||<|0.001|TWO_SIDED|95.0|1.24|2.22|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||2.22|1.24|<0.001
72571942|NCT02912650|144671808|SUPERIORITY_OR_OTHER||LS Mean Difference|2.05|||<|0.001|TWO_SIDED|95.0|1.35|2.74|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||2.74|1.35|<0.001
72529988|NCT01014442|144589680|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-0.00383||||0.0572|TWO_SIDED|95.0|-0.00761|0.0001|||Wilcoxon rank sum test|||Dose-Normalized AUC0-12 of MPA at Day 8. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.00010|-0.00761|0.0572
72529989|NCT01014442|144589680|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-0.09626||||0.3198|TWO_SIDED|95.0|-0.25269|0.11464|||Wilcoxon rank sum test|||Dose-Normalized AUC0-12 of MPAG at Day 8. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.11464|-0.25269|0.3198
72529990|NCT01014442|144589680|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-0.00131||||0.0845|TWO_SIDED|95.0|-0.00352|0.00013|||Wilcoxon rank sum test|||Dose-Normalized AUC0-12 of AcMPAG at Day 8. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.00013|-0.00352|0.0845
72529991|NCT01014442|144589680|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-0.00001||||0.1769|TWO_SIDED|95.0|-0.000025|0.0000043|||Wilcoxon rank sum test|||Dose-Normalized AUC0-12 of Free MPA at Day 8. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.0000043|-0.0000250|0.1769
72529992|NCT01014442|144589681|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-0.0049||||0.0048|TWO_SIDED|95.0|-0.00876|-0.00148|||Wilcoxon rank sum test|||Dose-Normalized AUC0-12 of MPA at Day 20. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||-0.00148|-0.00876|0.0048
72529993|NCT01014442|144589681|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-0.14764||||0.0277|TWO_SIDED|95.0|-0.31026|-0.01067|||Wilcoxon rank sum test|||Dose-Normalized AUC0-12 of MPAG at Day 20. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||-0.01067|-0.31026|0.0277
72529994|NCT01014442|144589681|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-0.0035||||0.0002|TWO_SIDED|95.0|-0.00476|0.00168|||Wilcoxon rank sum test|||Dose-Normalized AUC0-12 of AcMPAG at Day 20. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.00168|-0.00476|0.0002
72529995|NCT01014442|144589681|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-0.0000138||||0.1661|TWO_SIDED|95.0|-0.0000295|0.0000047|||Wilcoxon rank sum test|||Dose-Normalized AUC0-12 of Free MPA at Day 20. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.0000047|-0.0000295|0.1661
72529996|NCT01014442|144589682|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|0.00054||||0.9417|TWO_SIDED|95.0|-0.01037|0.01042|||Wilcoxon rank sum test|||Dose-Normalized AUC0-12 of MPA at Day 90. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.01042|-0.01037|0.9417
72529997|NCT01014442|144589682|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-0.1461||||0.2941|TWO_SIDED|95.0|-0.39951|0.12988|||Wilcoxon rank sum test|||Dose-Normalized AUC0-12 of MPAG at Day 90. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.12988|-0.39951|0.2941
72571943|NCT02912650|144671808|SUPERIORITY_OR_OTHER||LS Mean Difference|0.92||||0.01|TWO_SIDED|95.0|0.22|1.62|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.62|0.22|0.010
72571944|NCT02912650|144671808|SUPERIORITY_OR_OTHER||LS Mean Difference|1.12|||<|0.001|TWO_SIDED|95.0|0.63|1.61|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.61|0.63|<0.001
72571945|NCT02912650|144671808|SUPERIORITY_OR_OTHER||LS Mean Difference|2.18|||<|0.001|TWO_SIDED|95.0|1.47|2.88|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||2.88|1.47|<0.001
72571946|NCT02912650|144671808|SUPERIORITY_OR_OTHER||LS Mean Difference|0.57||||0.022|TWO_SIDED|95.0|0.08|1.06|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.06|0.08|0.022
72571947|NCT02912650|144671808|SUPERIORITY_OR_OTHER||LS Mean Difference|1.45|||<|0.001|TWO_SIDED|95.0|0.95|1.95|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.95|0.95|<0.001
72369193|NCT02023697|144248520|OTHER||Hazard Ratio (HR)|1.549||||0.155|TWO_SIDED|80.0|1.041|2.306|||Log Rank||Arm C/Arm A|||2.306|1.041|0.1550
72369194|NCT02023697|144248524|OTHER||Hazard Ratio (HR)|0.969||||0.8284|TWO_SIDED|80.0|0.805|1.167|||Log Rank||Arm B/Arm (A+C)|||1.167|0.805|0.8284
72369195|NCT02023697|144248526|OTHER||Hazard Ratio (HR)|1.059||||0.7896|TWO_SIDED|80.0|0.804|1.396|||Log Rank||Arm C/Arm A|||1.396|0.804|0.7896
72369196|NCT02023697|144248530|OTHER||Hazard Ratio (HR)|0.986||||0.9274|TWO_SIDED|80.0|0.803|1.21|||Log Rank||Arm B/Arm (A+C)|||1.210|0.803|0.9274
72369197|NCT02023697|144248532|OTHER||Hazard Ratio (HR)|1.134||||0.5754|TWO_SIDED|80.0|0.85|1.514|||Log Rank||Arm C/Arm A|||1.514|0.850|0.5754
72369198|NCT02023697|144248538|OTHER||Hazard Ratio (HR)|0.898||||0.6214|TWO_SIDED|80.0|0.678|1.188|||Log Rank||Arm B/Arm (A+C)|||1.188|0.678|0.6214
72369199|NCT02023697|144248540|OTHER||Hazard Ratio (HR)|0.863||||0.7214|TWO_SIDED|80.0|0.505|1.475|||Log Rank||Arm C/Arm A|||1.475|0.505|0.7214
72369200|NCT01009619|144248549|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Chi-squared, Corrected|||The frequency or rate of specific events (i.e. acute rejection, cytomegalovirus (CMV) and non-CMV infections) was calculated by determining the number of events per year of study time for each subject, correcting for CMV-mismatch status.||||<0.05
72369201|NCT01009619|144248550|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Chi-squared, Corrected|||The frequency or rate of specific events (i.e. acute rejection, cytomegalovirus (CMV) and non-CMV infections) was calculated by determining the number of events per year of study time for each subject, correcting for CMV-mismatch status.||||<0.05
72529998|NCT01014442|144589682|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|0.00033||||0.817|TWO_SIDED|95.0|-0.00361|0.00421|||Wilcoxon rank sum test|||Dose-Normalized AUC0-12 of AcMPAG at Day 90. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.00421|-0.00361|0.8170
72529999|NCT01014442|144589682|SUPERIORITY_OR_OTHER||Hodge-Lehmann estimator|-0.0000239||||0.1927|TWO_SIDED|95.0|-0.0000594|0.0000154|||Wilcoxon rank sum test|||Dose-Normalized AUC0-12 of Free MPA at Day 90. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.0000154|-0.0000594|0.1927
72530000|NCT01014442|144589683|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|0.1616||||0.0821|TWO_SIDED|95.0|-0.0121|0.4188|||Wilcoxon rank sum test|||Free Fraction of Free MPA at Day 4. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.4188|-0.0121|0.0821
72530001|NCT01014442|144589684|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|0.0427||||0.3628|TWO_SIDED|95.0|-0.0455|0.1221|||Wilcoxon rank sum test|||Free Fraction of Free MPA at Day 8. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.1221|-0.0455|0.3628
72530002|NCT01014442|144589685|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|0.001||||0.9873|TWO_SIDED|95.0|-0.1152|0.1173|||Wilcoxon rank sum test|||Free Fraction of Free MPA at Day 20. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.1173|-0.1152|0.9873
72530003|NCT01014442|144589686|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-0.0857||||0.2178|TWO_SIDED|95.0|-0.187|0.0265|||Wilcoxon rank sum test|||Free Fraction of Free MPA at Day 90. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.0265|-0.1870|0.2178
72530004|NCT01014442|144589692|SUPERIORITY_OR_OTHER||Difference in rates|-1.8||||1|TWO_SIDED|95.0|-24.9|22.1|||Fisher Exact|||||22.1|-24.9|1.0000
72530005|NCT00724594|144589705|OTHER|||||||0.9||||||not significant|t-test, 2 sided|||Term infant cohort : NAC vs control H0= there will be no difference in resistive index in Middle Cerebral Artery after N-acetylcysteine or saline in the term cohort.||||0.9
72530006|NCT00724594|144589705|OTHER|||||||0.9|||||||t-test, 2 sided|||Preterm infant cohort: NAC vs control H0= there will be no difference in resisitive index in MCA after N-acetylcysteine or saline in preterm cohort||||0.9
72530007|NCT00724594|144589706|OTHER|||||||0.9||||||not significant|t-test, 2 sided|||Maternal cohort: NAC versus control l H0= PT will not be different in mothers after NAC or saline||||0.9
72530008|NCT00724594|144589706|OTHER|||||||0.9|||||||t-test, 2 sided|||Infant cohort: NAC versus control H0= prothrombin time will not be different in the infants after NAC or saline||||0.9
72530009|NCT00724594|144589707|OTHER|||||||0.072|||||||t-test, 2 sided|||correcting for gestational age at birth||||0.072
72530010|NCT00724594|144589708|OTHER|||||||0.014|||||||t-test, 2 sided|||||||0.014
72530011|NCT03123549|144589761|SUPERIORITY|||||||0.017|||||||t-test, 1 sided|||||||0.017
72530012|NCT03742271|144589812|SUPERIORITY|Superiority was concluded in the lower limit of the 95% confidence interval was above 0.50.|Proportion|0.974|||||TWO_SIDED|95.0|0.925|0.995|||Binomial Exact Test|||This study was powered to test the hypothesis that at least 50% will have an acceptable lens fitting.||0.995|0.925|
72530013|NCT01624974|144589819|SUPERIORITY||Difference in Least Squares (LS) Means|0.047||||0.282|TWO_SIDED|95.0|-0.039|0.134|||LDA model|The LDA model assumes that repeated measurements follow a multivariate normal distribution.||||0.134|-0.039|0.282
72530014|NCT01468844|144589845|OTHER|The mean difference between the minocycline and placebo arms in change in BCVA in the study eye at Month 12 compared to baseline is reported.|Mean Difference (Net)|15.3|||||TWO_SIDED||||||||Difference = Minocycline - Placebo|||||
72530015|NCT01468844|144589846|OTHER|The difference between the minocycline and placebo treatment arms in number of participants improving ≥ 1 logOCT scale step in the study eye at Month 12 compared to baseline is reported.|Difference in Number of Participants|0.0|||||TWO_SIDED||||||||Difference = Minocycline - Placebo|||||
72530016|NCT01468844|144589847|OTHER|The difference between the minocycline and placebo treatment arms in number of participants improving ≥ 1 logOCT scale step in the study eye at Month 24 compared to baseline is reported|Difference in Number of Participants|0.0|||||TWO_SIDED||||||||Difference = Minocycline - Placebo|||||
72530017|NCT01468844|144589848|OTHER|The mean difference between the minocycline and placebo treatment arms in number of bevacizumab injections received from baseline to Month 12 is reported.|Mean Difference (Net)|-5.0|STANDARD_DEVIATION|2.3|||TWO_SIDED||||||||Difference = Minocycline - Placebo|||||
72530018|NCT01468844|144589849|OTHER|The mean difference between the minocycline and placebo treatment arms in number of bevacizumab injections received from baseline to Month 24 is reported.|Mean Difference (Net)|-8.2|STANDARD_DEVIATION|4.4|||TWO_SIDED||||||||Difference = Minocycline - Placebo|||||
72530019|NCT01468844|144589850|OTHER|The mean difference between the minocycline and placebo groups in the change in macular sensitivity in the study eye at Month 3 compared to baseline is reported.|Mean Difference (Net)|-2.5|STANDARD_DEVIATION|1.3|||TWO_SIDED||||||||Difference = Minocycline - Placebo|||||
72530020|NCT01468844|144589851|OTHER|The mean difference between the minocycline and placebo groups in the change in macular sensitivity in the study eye at Month 6 compared to baseline is reported.|Mean Difference (Net)|-0.8|STANDARD_DEVIATION|3.5|||TWO_SIDED||||||||Difference = Minocycline - Placebo|||||
72530021|NCT01468844|144589852|OTHER|The mean difference between the minocycline and placebo groups in the change in macular sensitivity in the study eye at Month 12 compared to baseline is reported.|Mean Difference (Net)|-3.0|STANDARD_DEVIATION|3.2|||TWO_SIDED||||||||Difference = Minocycline - Placebo|||||
72530022|NCT01468844|144589853|OTHER|The mean difference between the minocycline and placebo groups in the change in macular sensitivity in the study eye at Month 18 compared to baseline is reported.|Mean Difference (Net)|-5.4|STANDARD_DEVIATION|2.8|||TWO_SIDED||||||||Difference = Minocycline - Placebo|||||
72530023|NCT01468844|144589854|OTHER|The mean difference between the minocycline and placebo groups in the change in macular sensitivity in the study eye at Month 24 compared to baseline is reported.|Mean Difference (Net)|-5.4|STANDARD_DEVIATION|3.8|||TWO_SIDED||||||||Difference = Minocycline - Placebo|||||
72530024|NCT01468844|144589855|OTHER|The mean difference between the minocycline and placebo arms in change in BCVA in the study eye at Month 24 compared to baseline is reported.|Mean Difference (Net)|30.0|||||TWO_SIDED||||||||Difference = Minocycline - Placebo|||||
72530025|NCT01468844|144589856|OTHER|The mean difference between the minocycline and placebo treatment arms in change in retinal thickness as measured by OCT in the study eye at Month 6 compared to baseline is reported.|Mean Difference (Net)|39.3|STANDARD_DEVIATION|113.3|||TWO_SIDED||||||||Difference = Minocycline - Placebo|||||
72530026|NCT01468844|144589857|OTHER|The mean difference between the minocycline and placebo treatment arms in change in retinal thickness as measured by OCT in the study eye at Month 12 compared to baseline is reported.|Mean Difference (Net)|313.2|STANDARD_DEVIATION|267.3|||TWO_SIDED||||||||Difference = Minocycline - Placebo|||||
72530027|NCT01468844|144589858|OTHER|The mean difference between the minocycline and placebo treatment arms in change in retinal thickness as measured by OCT in the study eye at Month 18 compared to baseline is reported.|Mean Difference (Net)|428.5|STANDARD_DEVIATION|146.2|||TWO_SIDED||||||||Difference = Minocycline - Placebo|||||
72530028|NCT01468844|144589859|OTHER|The mean difference between the minocycline and placebo treatment arms in change in retinal thickness as measured by OCT in the study eye at Month 24 compared to baseline is reported.|Mean Difference (Net)|119.0|STANDARD_DEVIATION|66.6|||TWO_SIDED||||||||Difference = Minocycline - Placebo|||||
72530029|NCT01468844|144589860|OTHER|The difference between the minocycline and treatment arms in the number of participants experiencing a decrease in fluid leakage at Month 12 compared to baseline is reported.|Difference in Number of Participants|1.0|||||TWO_SIDED||||||||Difference = Minocycline - Placebo|||||
72530030|NCT01468844|144589860|OTHER|The difference between the minocycline and treatment arms in the number of participants experiencing an increase in fluid leakage at Month 12 compared to baseline is reported.|Difference in Number of Participants|-1.0|||||TWO_SIDED||||||||Difference = Minocycline - Placebo|||||
72530031|NCT01468844|144589860|OTHER|The difference between the minocycline and treatment arms in the number of participants experiencing no change in fluid leakage at Month 12 compared to baseline is reported.|Difference in Number of Participants|0.0|||||TWO_SIDED||||||||Difference = Minocycline - Placebo|||||
72571948|NCT02912650|144671808|SUPERIORITY_OR_OTHER||LS Mean Difference|1.6|||<|0.001|TWO_SIDED|95.0|0.9|2.3|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||2.30|0.90|<0.001
72571949|NCT02912650|144671808|SUPERIORITY_OR_OTHER||LS Mean Difference|0.72||||0.045|TWO_SIDED|95.0|0.02|1.43|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.43|0.02|0.045
72571950|NCT02912650|144671808|SUPERIORITY_OR_OTHER||LS Mean Difference|0.88|||<|0.001|TWO_SIDED|95.0|0.38|1.38|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.38|0.38|<0.001
72530032|NCT01468844|144589861|OTHER|The difference between the minocycline and treatment arms in the number of participants experiencing a decrease in fluid leakage at Month 24 compared to baseline is reported.|Difference in Number of Participants|1.0|||||TWO_SIDED||||||||Difference = Minocycline - Placebo|||||
72530033|NCT01468844|144589861|OTHER|The difference between the minocycline and treatment arms in the number of participants experiencing an increase in fluid leakage at Month 24 compared to baseline is reported.|Difference in Number of Participants|0.0|||||TWO_SIDED||||||||Difference = Minocycline - Placebo|||||
72530034|NCT01468844|144589861|OTHER|The difference between the minocycline and treatment arms in the number of participants experiencing no change in fluid leakage at Month 24 compared to baseline is reported.|Difference in Number of Participants|0.0|||||TWO_SIDED||||||||Difference = Minocycline - Placebo|||||
72530035|NCT01408862|144589867|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.04|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||"Results will be expressed as mean + SD from independent experiments. Statistical significance between means were determined by Wilcoxon-paired test. Variable will be log-transformed if they were not normally distributed. . We used the CSS/ Statistica program package, StatSoft V 6.0.~This analysis applies to both GLP1R and GIPR categories"||||0.04
72530036|NCT01408862|144589868|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.2|||||||ANOVA|||Results will be expressed as mean + SD from independent experiments. Statistical significance between means were determined by two-way ANOVA with repeated measures on one factor, for variables measured in several consecutive times. Variable will be log-transformed if they were not normally distributed. Wilcoxon test for paired samples was used. The Statistica program package (StatSoft V 6.0) were used to perform these analyses, which applied to both GLP1R and GIPR agonist effect categories.||||0.20
72530037|NCT01813149|144589875|SUPERIORITY|||||||0.009|||||||t-test, 2 sided|df=20 t-statistic = 2.90||A t-test to see if expression of α1-AR differs between phenylephrine responders and non-responders||||0.009
72530038|NCT01882439|144589889|SUPERIORITY_OR_OTHER||Risk Difference (RD)|25.95|STANDARD_ERROR_OF_MEAN|5.73|<|0.0001|TWO_SIDED|95.0|14.72|37.19|||Large sample approximation|Missing response (MR) = non-response (NR)||||37.19|14.72|<0.0001
72571951|NCT02912650|144671808|SUPERIORITY_OR_OTHER||LS Mean Difference|1.78|||<|0.001|TWO_SIDED|95.0|1.09|2.47|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||2.47|1.09|<0.001
72407916|NCT00094653|144324117|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.6||||0.3351|TWO_SIDED|95.0|-10.9|3.7|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Sleep Disturbance change from baseline||3.7|-10.9|0.3351
72625635|NCT05715827|144780631|OTHER|Descriptive statistics will be used, presenting frequency, percentage, and 95% confidence intervals for each secondary endpoint: overall complication rate, major complication rate, readmission rate, reoperation rate, and Device Deficiencies (DD) rate through 30 days post-surgery. Secondary endpoints will be assessed overall and by surgery type (prostatectomy and cholecystectomy).|Overall Complication Rate|20.0|||||TWO_SIDED|95.0|9.1|35.6||Descriptive statistics and estimated rates were used. P-values were not calculated for secondary endpoints.||||The secondary objective is to assess the short-term safety outcome of the Medtronic Hugo™ RAS System when used for prostatectomy or cholecystectomy. Overall complication rate through 30-day post-surgery: A proportion of subjects with any postoperative complication within 30-days post-surgery using the investigational device||35.6|9.1|
72625636|NCT05715827|144780632|OTHER|Descriptive statistics will be used, presenting frequency, percentage, and 95% confidence intervals for each secondary endpoint: overall complication rate, major complication rate, readmission rate, reoperation rate, and Device Deficiencies (DD) rate through 30 days post-surgery. Secondary endpoints will be assessed overall and by surgery type (prostatectomy and cholecystectomy).|Major complication rate|5.0|||||TWO_SIDED|95.0|0.6|16.9||Descriptive statistics and estimated rates were used. P-values were not calculated for secondary endpoints.||||The secondary objective is to assess the short-term safety outcome of the Medtronic Hugo™ RAS System when used for prostatectomy or cholecystectomy. Overall complication rate through 30-day post-surgery: A proportion of subjects with any postoperative complication within 30-days post-surgery using the investigational device||16.9|0.6|
72407917|NCT00094653|144324117|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.8||||0.6291|TWO_SIDED|95.0|-9.1|5.5|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Appetite loss change from baseline||5.5|-9.1|0.6291
72407918|NCT00094653|144324117|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.3||||0.7675|TWO_SIDED|95.0|-7.4|10.1|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Appetite Loss change from baseline||10.1|-7.4|0.7675
72407919|NCT00094653|144324117|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.1||||0.3911|TWO_SIDED|95.0|-10.2|4.0|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Appetite Loss change from baseline||4.0|-10.2|0.3911
72530039|NCT01882439|144589889|SUPERIORITY_OR_OTHER||Risk Difference (RD)|23.31|STANDARD_ERROR_OF_MEAN|5.71|<|0.0001|TWO_SIDED|95.0|12.1|34.51|||Large sample approximation|MR=NR||||34.51|12.10|<0.0001
72530040|NCT01882439|144589890|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.2529|STANDARD_ERROR_OF_MEAN|0.06422|<|0.0001|TWO_SIDED|95.0|-0.3792|-0.1266|||Mixed Models Analysis|No imputation||||-0.1266|-0.3792|<0.0001
72407920|NCT00094653|144324117|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.5||||0.0431|TWO_SIDED|95.0|-12.9|-0.2|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Constipation change from baseline||-0.2|-12.9|0.0431
72530041|NCT01882439|144589890|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.215|STANDARD_ERROR_OF_MEAN|0.06453||0.0009|TWO_SIDED|95.0|-0.3419|-0.0881|||Mixed Models Analysis|No imputation||||-0.0881|-0.3419|0.0009
72530042|NCT03125902|144589928|SUPERIORITY||Hazard Ratio (HR)|0.82||||0.2032|TWO_SIDED|95.0|0.6|1.12|||Log Rank|||Stratified Analysis||1.12|0.60|0.2032
72530043|NCT03125902|144589928|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.2601|TWO_SIDED|95.0|0.62|1.14|||Log Rank|||Unstratified Analysis||1.14|0.62|0.2601
72530044|NCT03125902|144589929|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.86||||0.1343|TWO_SIDED|95.0|0.7|1.05|||Log Rank|||||1.05|0.70|0.1343
72530045|NCT03125902|144589929|SUPERIORITY||Hazard Ratio (HR)|0.86||||0.1285|TWO_SIDED|95.0|0.7|1.05|||Log Rank|||Unstratified Analysis||1.05|0.70|0.1285
72530046|NCT03125902|144589930|SUPERIORITY||Hazard Ratio (HR)|1.11||||0.5798|TWO_SIDED|95.0|0.76|1.64|||Log Rank|||Stratified Analysis||1.64|0.76|0.5798
72530047|NCT03125902|144589930|SUPERIORITY||Hazard Ratio (HR)|1.18||||0.4035|TWO_SIDED|95.0|0.8|1.72|||Log Rank|||Unstratified Analysis||1.72|0.80|0.4035
72530048|NCT03125902|144589931|SUPERIORITY||Hazard Ratio (HR)|1.12||||0.3425|TWO_SIDED|95.0|0.88|1.43|||Log Rank|||Stratified analysis||1.43|0.88|0.3425
72530049|NCT03125902|144589931|SUPERIORITY||Hazard Ratio (HR)|1.16||||0.2166|TWO_SIDED|95.0|0.92|1.48|||Log Rank|||Unstratified Analysis||1.48|0.92|0.2166
72530050|NCT03125902|144589933|OTHER|Stratified analysis|Hazard Ratio (HR)|0.94||||0.6465|TWO_SIDED|95.0|0.71|1.24|||Log Rank|||||1.24|0.71|0.6465
72530051|NCT03125902|144589935|OTHER||Odds Ratio (OR)|1.44||||0.1526|TWO_SIDED|95.0|0.87|2.37|||Cochran-Mantel-Haenszel|||||2.37|0.87|0.1526
72530052|NCT03125902|144589936|OTHER||Odds Ratio (OR)|1.4||||0.1834|TWO_SIDED|95.0|0.85|2.31|||Cochran-Mantel-Haenszel|||||2.31|0.85|0.1834
72530053|NCT03125902|144589937|OTHER||Odds Ratio (OR)|1.42||||0.0513|TWO_SIDED|95.0|1.0|2.02|||Cochran-Mantel-Haenszel|||||2.02|1.00|0.0513
72530054|NCT03125902|144589938|OTHER||Odds Ratio (OR)|1.3||||0.1226|TWO_SIDED|95.0|0.93|1.81|||Cochran-Mantel-Haenszel|||||1.81|0.93|0.1226
72530055|NCT03125902|144589939|OTHER|Unstratified Analysis|Hazard Ratio (HR)|0.74||||0.0641|TWO_SIDED|95.0|0.54|1.02|||Log Rank|||||1.02|0.54|0.0641
72625637|NCT05715827|144780633|OTHER|Descriptive statistics will be used, presenting frequency, percentage, and 95% confidence intervals for each secondary endpoint: overall complication rate, major complication rate, readmission rate, reoperation rate, and Device Deficiencies (DD) rate through 30 days post-surgery. Secondary endpoints will be assessed overall and by surgery type (prostatectomy and cholecystectomy).|Readmission rate|10.0|||||TWO_SIDED|95.0|2.8|23.7||Descriptive statistics and estimated rates were used. P-values were not calculated for secondary endpoints.||||The secondary objective is to assess the short-term safety outcome of the Medtronic Hugo™ RAS System when used for prostatectomy or cholecystectomy. Overall complication rate through 30-day post-surgery: A proportion of subjects with any postoperative complication within 30-days post-surgery using the investigational device||23.7|2.8|
72407921|NCT00094653|144324117|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.9||||0.0101|TWO_SIDED|95.0|-17.4|-2.4|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Constipation change from baseline||-2.4|-17.4|0.0101
72407922|NCT00094653|144324117|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.4||||0.2796|TWO_SIDED|95.0|-2.8|9.5|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Constipation change from baseline||9.5|-2.8|0.2796
72530056|NCT03125902|144589949|SUPERIORITY||Hazard Ratio (HR)|0.62||||0.01227|TWO_SIDED|95.0|0.42|0.9|||Log Rank|||Unstratified Analysis||0.90|0.42|0.01227
72530057|NCT01997333|144589950|SUPERIORITY|||||||0.761|||||||Log Rank|Stratified log rank test.||||||0.761
72530058|NCT01997333|144589951|SUPERIORITY|||||||0.264|||||||Cochran-Mantel-Haenszel|Adjusted for stratification factors.||||||0.264
72530059|NCT01997333|144589953|SUPERIORITY|||||||0.726|||||||Log Rank|Stratified log rank.||||||0.726
72530060|NCT02269709|144589956|OTHER|Changes in mean liver shear wave speed (SWS) between time points were assessed using a mixed-effect model with post hoc Tukey correction.|||||<|0.0001|||||||Mixed Models Analysis|||Comparison of Baseline and Follow-up #1||||<0.0001
72530061|NCT02269709|144589956|OTHER|Changes in mean liver shear wave speed (SWS) between time points were assessed using a mixed-effect model with post hoc Tukey correction.|||||<|0.0001|||||||Mixed Models Analysis|||Comparison of Baseline vs. Follow up #2||||<0.0001
72530062|NCT02269709|144589956|OTHER|Changes in mean liver shear wave speed (SWS) between time points were assessed using a mixed-effect model with post hoc Tukey correction.|||||<|0.0001|||||||Mixed Models Analysis|||Comparison of Baseline vs. Follow-up #3||||<0.0001
72530063|NCT02269709|144589957|OTHER|Mean IVC pressures from different time points were compared using the Wilcoxon signed-rank test.|||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
72530064|NCT04411472|144589961|SUPERIORITY||Odds Ratio (OR)|1.18||||0.8025|TWO_SIDED|95.0|0.805|1.732|||One-sided p-value|||||1.732|0.805|0.8025
72530065|NCT04411472|144589962|SUPERIORITY||Odds Ratio (OR)|0.54||||0.1824|TWO_SIDED|95.0|0.139|2.131|||One-sided p-value|||||2.131|0.139|0.1824
72530066|NCT04411472|144589963|SUPERIORITY||Odds Ratio (OR)|0.02||||0.008|TWO_SIDED|95.0|0.001|0.405|||One-sided p-value|||||0.405|0.001|0.0080
72530067|NCT04411472|144589964|SUPERIORITY||Odds Ratio (OR)|0.94||||0.3894|TWO_SIDED|95.0|0.606|1.454|||One-sided p-value|||||1.454|0.606|0.3894
72530068|NCT04411472|144589965|SUPERIORITY||Odds Ratio (OR)|0.47||||0.1237|TWO_SIDED|95.0|0.128|1.697|||One-sided p-value|||||1.697|0.128|0.1237
72530069|NCT04411472|144589967|SUPERIORITY||z-score statistic difference proportions|-7.9||||0.019|TWO_SIDED|95.0|-15.4|-0.4||one-sided p-value based on the z-score statistic for the difference in proportions|one-sided p-value|||||-0.4|-15.4|0.019
72530070|NCT04411472|144589968|SUPERIORITY|||||||0.546|||||||One-sided p-value from re-randomization|||Days alive and free of organ support through to Day 28||||0.5460
72530071|NCT04411472|144589968|SUPERIORITY|||||||0.677|||||||One-sided p-value from re-randomization|||Number of days free of MV||||0.6770
72530072|NCT04411472|144589968|SUPERIORITY|||||||0.993|||||||One-sided p-value from re-randomization|||Number of days free of RRT||||0.9930
72530073|NCT04411472|144589968|SUPERIORITY|||||||0.779|||||||One-sided p-value from re-randomization|||Number of days free of vasopressors and inotropes||||0.7790
72530074|NCT04411472|144589969|SUPERIORITY|||||||0.051|||||||One-sided p-value from re-randomization|||Days alive and free of organ support through Day 28||||0.0510
72530075|NCT04411472|144589969|SUPERIORITY|||||||0.013|||||||One-sided p-value from re-randomization|||Number of days free of MV||||0.0130
72530076|NCT04411472|144589969|SUPERIORITY|||||||0.025|||||||One-sided p-value from re-randomization|||Number of days free of RRT||||0.0250
72530077|NCT04411472|144589969|SUPERIORITY|||||||0.073|||||||One-sided p-value from re-randomization|||Number of days free of vasopressors and inotropes||||0.0730
72530078|NCT04411472|144589970|SUPERIORITY|||||||1|||||||One-sided p-value from re-randomization|||Days alive and free of organ support through Day 28||||1.0000
72530079|NCT04411472|144589970|SUPERIORITY|||||||0.979|||||||One-sided p-value from re-randomization|||Number of days free of MV||||0.9790
72530080|NCT04411472|144589970|SUPERIORITY|||||||0.675|||||||One-sided p-value from re-randomization|||Number of days free of RRT||||0.6750
72625638|NCT05715827|144780634|OTHER|Descriptive statistics will be used, presenting frequency, percentage, and 95% confidence intervals for each secondary endpoint: overall complication rate, major complication rate, readmission rate, reoperation rate, and Device Deficiencies (DD) rate through 30 days post-surgery. Secondary endpoints will be assessed overall and by surgery type (prostatectomy and cholecystectomy).|Reoperation rate|0.0|||||TWO_SIDED|||||Descriptive statistics and estimated rates were used. P-values were not calculated for secondary endpoints.||||The secondary objective is to assess the short-term safety outcome of the Medtronic Hugo™ RAS System when used for prostatectomy or cholecystectomy. Overall complication rate through 30-day post-surgery: A proportion of subjects with any postoperative complication within 30-days post-surgery using the investigational device||||
72530081|NCT04411472|144589970|SUPERIORITY|||||||0.031|||||||One-sided p-value from re-randomization|||Number of days free of vasopressors and inotropes||||0.0310
72530082|NCT04411472|144589971|SUPERIORITY|||||||0.545|||||||One-sided p-value from re-randomization|||||||0.5450
72530083|NCT04411472|144589972|SUPERIORITY|||||||0.081|||||||One-sided p-value from re-randomization|||||||0.0810
72530084|NCT04411472|144589973|SUPERIORITY|||||||0.979|||||||One-sided p-value from re-randomization|||||||0.9790
72530085|NCT04411472|144589974|SUPERIORITY||Hazard Ratio (HR)|1.08||||0.6916|TWO_SIDED|95.0|0.806|1.437|||One-sided p-value|||||1.437|0.806|0.6916
72530086|NCT04411472|144589975|SUPERIORITY||Hazard Ratio (HR)|0.47||||0.0628|TWO_SIDED|95.0|0.18|1.234|||One-sided p-value|||||1.234|0.180|0.0628
72530087|NCT04411472|144589976|SUPERIORITY||Hazard Ratio (HR)|0.01|||<|0.0001|TWO_SIDED|95.0|0.001|0.054|||One-sided p-value|||||0.054|0.001|<0.0001
72530088|NCT00819052|144589986|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority of nevirapine XR to nevirapine IR was established if the lower bound of the confidence interval was greater than -12%|Cochran's statistic|1.0||||||95.0|-4.3|6.2|||Cochran's statistic||Weighted treatment difference and corresponding variance were calculated based on Cochran's statistic.|||6.2|-4.3|
72530089|NCT00819052|144589999|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.64||||0.7587||95.0|-34.34|25.05|||ANCOVA|Means adjusted for background ARV (Antiretroviral) stratum||||25.05|-34.34|0.7587
72530090|NCT01277666|144590035|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.5||||0.546|TWO_SIDED|95.0|-6.1|11.0|||Mantel Haenszel|||comparison of Placebo and GSK1605786A 500 mg once daily||11.0|-6.1|0.546
72530091|NCT01277666|144590035|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.1||||0.648|TWO_SIDED|95.0|-6.5|10.7|||Mantel Haenszel|||comparison of Placebo and GSK1605786A 500 mg twice daily||10.7|-6.5|0.648
72530092|NCT01277666|144590036|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.0||||0.592|TWO_SIDED|95.0|-8.8|4.8|||Mantel Haenszel|||||4.8|-8.8|0.592
72530093|NCT01277666|144590036|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.4||||0.475|TWO_SIDED|95.0|-9.2|4.4|||Mantel Haenszel|||||4.4|-9.2|0.475
72530094|NCT01277666|144590037|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.0||||0.415|TWO_SIDED|95.0|-4.4|10.3|||Mantel Haenszel|||||10.3|-4.4|0.415
72530095|NCT01277666|144590037|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.5||||0.354|TWO_SIDED|95.0|-3.9|10.9|||Mantel Haenszel|||||10.9|-3.9|0.354
72530096|NCT01277666|144590038|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.985|TWO_SIDED|95.0|-5.2|5.2|||Mantel Haenszel|||||5.2|-5.2|0.985
72530097|NCT01277666|144590038|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0||||0.709|TWO_SIDED|95.0|-6.1|4.1|||Mantel Haenszel|||||4.1|-6.1|0.709
72530098|NCT01277666|144590039|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.0||||0.633|TWO_SIDED|95.0|-6.5|10.4|||Mantel Haenszel|||||10.4|-6.5|0.633
72530099|NCT01277666|144590039|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.6||||0.889|TWO_SIDED|95.0|-7.8|9.0|||Mantel Haenszel|||||9.0|-7.8|0.889
72530100|NCT01277666|144590040|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.0||||0.541|TWO_SIDED|95.0|-8.1|4.2|||Mantel Haenszel|||||4.2|-8.1|0.541
72530101|NCT01277666|144590040|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.4||||0.43|TWO_SIDED|95.0|-8.5|3.7|||Mantel Haenszel|||||3.7|-8.5|0.430
72530102|NCT01277666|144590041|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.13|STANDARD_ERROR_OF_MEAN|2.426||0.642|TWO_SIDED|95.0|-5.89|3.64||P-values were obtained from an analysis of covariance model with baseline score as the covariate.|ANCOVA|||Week 8||3.64|-5.89|0.642
72530103|NCT01277666|144590041|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.34|STANDARD_ERROR_OF_MEAN|2.652||0.898|TWO_SIDED|95.0|-5.55|4.87||P-values were obtained from an analysis of covariance model with baseline score as the covariate.|ANCOVA|||Week 12||4.87|-5.55|0.898
72530104|NCT01277666|144590041|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.37|STANDARD_ERROR_OF_MEAN|2.467||0.173|TWO_SIDED|95.0|-1.48|8.21||P-values were obtained from an analysis of covariance model with baseline score as the covariate.|ANCOVA|||Week 8||8.21|-1.48|0.173
72530105|NCT01277666|144590041|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.85|STANDARD_ERROR_OF_MEAN|2.697||0.493|TWO_SIDED|95.0|-3.45|7.15||P-values were obtained from an analysis of covariance model with baseline score as the covariate.|ANCOVA|||Week 12||7.15|-3.45|0.493
72530106|NCT00982111|144590059|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.01||||0.9561|TWO_SIDED|95.0|0.84|1.21|||Log Rank|||||1.21|0.84|0.9561
72530107|NCT00982111|144590060|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.96||||0.6647|TWO_SIDED|95.0|0.8|1.16|||Log Rank|||||1.16|0.80|0.6647
72530108|NCT00982111|144590061|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.96||||0.7945|TWO_SIDED|95.0|0.68|1.34|||Cochran-Mantel-Haenszel|||||1.34|0.68|0.7945
72530109|NCT00982111|144590062|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.18||||0.0459|TWO_SIDED|95.0|1.0|1.39|||Log Rank|||||1.39|1.00|0.0459
72530110|NCT03512028|144590069|SUPERIORITY||Mean Difference (Net)|3.2||||0.002|TWO_SIDED|||||Interaction effect of group x time from pre- to post- intervention|ANOVA||Estimated difference between slopes|Mixed model ANOVA with group (RLIC, Sham) and time (pre-, post-, and follow-up ). The main analysis of interest is the group x time interaction from pre- to post-.||||0.002
72530111|NCT03512028|144590069|SUPERIORITY|||||||0.001||||||Main effect of time|ANOVA|||||||0.001
72530112|NCT03512028|144590069|SUPERIORITY|||||||0.844||||||Main effect of group|ANOVA|||||||0.844
72530113|NCT01906489|144590093|SUPERIORITY||Odds Ratio (OR)|11.4739|||=|0.0001|TWO_SIDED|95.0|3.3505|39.2931|||Fisher Exact|||||39.2931|3.3505|=0.0001
72530114|NCT01906489|144590094|OTHER||||||<|0.0001|TWO_SIDED||||||Fisher Exact|||||||<0.0001
72530115|NCT01906489|144590095|OTHER||||||<|0.0001|||||||Fisher Exact|||||||<0.0001
72530116|NCT01906489|144590097|OTHER||||||=|0.0953|TWO_SIDED||||||Fisher Exact|||||||=0.0953
72530117|NCT01906489|144590098|OTHER||||||=|0.1238|TWO_SIDED||||||Fisher Exact|||||||=0.1238
72530118|NCT01906489|144590099|OTHER||||||<|0.0001|TWO_SIDED||||||Fisher Exact|||||||<0.0001
72530119|NCT01906489|144590100|OTHER||||||=|0.0019|||||||t-test, 2 sided|||Week 2||||=0.0019
72530120|NCT01906489|144590100|OTHER||||||<|0.0001|||||||t-test, 2 sided|||Week 4||||<0.0001
72530121|NCT01906489|144590100|OTHER||||||<|0.0001|||||||t-test, 2 sided|||Week 6||||<0.0001
72530122|NCT01906489|144590100|OTHER||||||<|0.0001|||||||t-test, 2 sided|||Week 8||||<0.0001
72530123|NCT01906489|144590100|OTHER||||||<|0.0001|||||||t-test, 2 sided|||Week 12||||<0.0001
72530124|NCT01906489|144590100|OTHER||||||<|0.0001|||||||t-test, 2 sided|||Week 16||||<0.0001
72530125|NCT01906489|144590100|OTHER||||||<|0.0001|||||||t-test, 2 sided|||Week 19||||<0.0001
72530126|NCT01906489|144590100|OTHER||||||<|0.0001|||||||t-test, 2 sided|||Week 20||||<0.0001
72530127|NCT01906489|144590102|OTHER||||||<|0.0001|||||||t-test, 2 sided|||Week 2||||<0.0001
72530128|NCT01906489|144590102|OTHER||||||<|0.0001|||||||t-test, 2 sided|||Week 4||||<0.0001
72530129|NCT01906489|144590102|OTHER||||||<|0.0001|||||||t-test, 2 sided|||Week 6||||<0.0001
72530130|NCT01906489|144590102|OTHER||||||<|0.0001|||||||t-test, 2 sided|||Week 8||||<0.0001
72530131|NCT01906489|144590102|OTHER||||||<|0.0001|||||||t-test, 2 sided|||Week 12||||<0.0001
72530132|NCT01906489|144590102|OTHER||||||<|0.0001|||||||t-test, 2 sided|||Week 16||||<0.0001
72530133|NCT01906489|144590102|OTHER||||||<|0.0001|||||||t-test, 2 sided|||Week 19||||<0.0001
72530134|NCT01906489|144590102|OTHER||||||<|0.0001|||||||t-test, 2 sided|||Week 20||||<0.0001
72530135|NCT01906489|144590104|OTHER||||||=|0.0031|||||||t-test, 2 sided|||Week 2||||=0.0031
72530136|NCT01906489|144590104|OTHER||||||<|0.0001|||||||t-test, 2 sided|||Week 4||||<0.0001
72530137|NCT01906489|144590104|OTHER||||||<|0.0001|||||||t-test, 2 sided|||Week 6||||<0.0001
72530138|NCT01906489|144590104|OTHER||||||<|0.0001|||||||t-test, 2 sided|||Week 8||||<0.0001
72530139|NCT01906489|144590104|OTHER||||||<|0.0001|||||||t-test, 2 sided|||Week 12||||<0.0001
72530140|NCT01906489|144590104|OTHER||||||<|0.0001|||||||t-test, 2 sided|||Week 16||||<0.0001
72530141|NCT01906489|144590104|OTHER||||||<|0.0001|||||||t-test, 2 sided|||Week 19||||<0.0001
72530142|NCT01906489|144590104|OTHER||||||<|0.0001|||||||t-test, 2 sided|||Week 20||||<0.0001
72530143|NCT01906489|144590106|OTHER||||||<|0.0001|||||||t-test, 2 sided|||Week 2||||<0.0001
72530144|NCT01906489|144590106|OTHER||||||=|0.0133|||||||t-test, 2 sided|||Week 4||||=0.0133
72530145|NCT01906489|144590106|OTHER||||||=|0.3053|||||||t-test, 2 sided|||Week 6||||=0.3053
72530146|NCT01906489|144590106|OTHER||||||=|0.1918|||||||t-test, 2 sided|||Week 8||||=0.1918
72530147|NCT01906489|144590106|OTHER||||||=|0.209|||||||t-test, 2 sided|||Week 12||||=0.2090
72530148|NCT01906489|144590106|OTHER||||||=|0.6184|||||||t-test, 2 sided|||Week 16||||=0.6184
72530149|NCT01906489|144590106|OTHER||||||=|0.3604|||||||t-test, 2 sided|||Week 19||||=0.3604
72530150|NCT01906489|144590106|OTHER||||||=|0.4056|||||||t-test, 2 sided|||Week 20||||=0.4056
72530151|NCT01906489|144590112|OTHER||Hazard Ratio (HR)|4.1451|||=|0.0017|TWO_SIDED|95.0|1.5752|10.908|||Log Rank|||||10.9080|1.5752|=0.0017
72530152|NCT02028182|144590147|OTHER||Kappa statistic-Concordance 0.4 mg/cm2|75.0|||||TWO_SIDED|95.0|60.4|94.0||||||||94.0|60.4|
72530153|NCT02028182|144590147|OTHER||Kappa statistic: Concordance 0.20 mg/cm2|65.0|||||TWO_SIDED|95.0|55.6|90.4||||||||90.4|55.6|
72530154|NCT02028182|144590147|OTHER||Kappa statistic: Concordance0.10 mg/cm2|60.0|||||TWO_SIDED|95.0|53.3|88.4||||||||88.4|53.3|
72530155|NCT01519648|144590150|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.872|STANDARD_ERROR_OF_MEAN|0.237||0.007|TWO_SIDED|95.0|1.178|2.977|||Chi-squared|||||2.977|1.178|0.007
72530156|NCT04524663|144590158|SUPERIORITY||Median Difference (Net)|0.59||||0.89|TWO_SIDED|95.0|-8.14|9.32|||Regression, Linear|||||9.32|-8.14|0.89
72530157|NCT04524663|144590159|SUPERIORITY||Median Difference (Net)|18.9||||0.02|TWO_SIDED|95.0|2.98|34.83|||Regression, Linear|||||34.83|2.98|0.02
72530158|NCT04524663|144590160|SUPERIORITY||Hazard Ratio (HR)|1.69||||0.24|TWO_SIDED|95.0|0.7|4.1|||Cox proportional hazards model|||||4.10|0.70|0.24
72530159|NCT04524663|144590161|SUPERIORITY|||||||0.49|||||||Fisher Exact|||||||0.49
72530160|NCT04524663|144590162|SUPERIORITY||Hazard Ratio (HR)|0.65||||0.24|TWO_SIDED|95.0|0.32|1.33|||Cox proportional hazards model|||||1.33|0.32|0.24
72530161|NCT00337935|144590165|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.6|STANDARD_ERROR_OF_MEAN|0.2||0.0062|TWO_SIDED|95.0|0.2|0.9||a priori theshold for statistical significance was p=0.05|ANCOVA|Baseline Hemoglobin was used as a covariate.||||0.9|0.2|.0062
72530162|NCT00337935|144590166|SUPERIORITY_OR_OTHER||||||<|0.001||||||A priori threshold for statistical significance p=0.05|Chi-squared|||||||<0.001
72530163|NCT00337935|144590167|SUPERIORITY_OR_OTHER||||||<|0.0001||||||A priori threshold for statistical significance p=0.05|Log Rank|||||||<0.0001
72530164|NCT02361307|144590186|SUPERIORITY|||||||0.05|||||||ANCOVA|||||||0.05
72530165|NCT00711009|144590187|NON_INFERIORITY_OR_EQUIVALENCE|The exact 95% confidence interval for the difference in response rates (LPV/r + RAL minus LPV/r + FTC/TDF) was used to assess non-inferiority. The LPV/r+RAL arm was considered non-inferior to the LPV/r+FTC/TDF arm because the lower limit of the confidence interval was \>/= -20%. Because the LPV/r+RAL arm was considered non-inferior based on the 20% margin, the results were assessed on a more rigorous 12% margin (-12%), as prespecified.|Diff. in Percentage of Subj. Responding|-1.6||||0.85|TWO_SIDED|95.0|-12.0|8.8|||exact binomial method|||The null hypothesis was that the response rate for the LPV/r + RAL arm was more than 20% lower than the response rate for the LPV/r + FTC/TDF arm. The planned sample size of 100 participants per treatment group provided 90% power to conclude that the LPV/r + RAL arm was non-inferior to the control arm, based on a non-inferiority margin of -20% (with a type I error rate of 0.05).||8.8|-12.0|0.850
72530166|NCT01682876|144590276|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was demonstrated for 2 to 5 years of age group if the lower limit of the 2-sided 97.5% confidence interval (CI) for the difference in seroresponse rate between the 2-dose vaccination schedule and the 1-dose vaccination schedule (2-dose schedule minus the 1-dose schedule) was greater than -10% for MenA|Vaccine Group Differences at Day 86|19.0|||||TWO_SIDED|97.5|10.0|28.9|||MN method|||Non-inferiority of seroresponse of two vaccinations vs.one vaccination for age cohort (2 to 5 years of age) for MenA||28.9|10|
72407923|NCT00094653|144324117|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.3||||0.194|TWO_SIDED|95.0|-2.2|10.8|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Diarrhea change from baseline||10.8|-2.2|0.1940
72530167|NCT01682876|144590276|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was demonstrated for 2 to 5 years of age group if the lower limit of the 2-sided 97.5% confidence interval (CI) for the difference in seroresponse rate between the 2-dose vaccination schedule and the 1-dose vaccination schedule (2-dose schedule minus the 1-dose schedule) was greater than -10% for MenC|Vaccine Group Differences at Day 86|27.0|||||TWO_SIDED|97.5|16.9|37.7|||MN method|||Non-inferiority of seroresponse of two vaccinations vs. one vaccination for age cohort (2 to 5 years of age) for MenC||37.7|16.9|
72530168|NCT01682876|144590276|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was demonstrated for 2 to 5 years of age group if the lower limit of the 2-sided 97.5% confidence interval (CI) for the difference in seroresponse rate between the 2-dose vaccination schedule and the 1-dose vaccination schedule (2-dose schedule minus the 1-dose schedule) was greater than -10% for MenW|Vaccine Group Differences at Day 86|14.0|||||TWO_SIDED|97.5|1.4|26.7|||MN method|||Non-inferiority of seroresponse of two vaccinations vs. one vaccination for age cohort (2 to 5 years of age) for MenW||26.7|1.4|
72530169|NCT01682876|144590276|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was demonstrated for 2 to 5 years of age group if the lower limit of the 2-sided 97.5% confidence interval (CI) for the difference in seroresponse rate between the 2-dose vaccination schedule and the 1-dose vaccination schedule (2-dose schedule minus the 1-dose schedule) was greater than -10% for Men Y|Vaccine Group differences at Day 86|27.0|||||TWO_SIDED|97.5|15.6|37.6|||MN method|||Non-inferiority of seroresponse of two vaccinations vs. one vaccination for age cohort (2 to 5 years of age) for MenY||37.6|15.6|
72530170|NCT01682876|144590276|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was demonstrated for 6 to 10 years of age group if the lower limit of the 2-sided 97.5% confidence interval (CI) for the difference in seroresponse rate between the 2-dose vaccination schedule and the 1-dose vaccination schedule (2-dose schedule minus the 1-dose schedule) was greater than -10% for MenA|Vaccines Group Differences at Day 86|11.0|||||TWO_SIDED|97.5|1.7|21.3|||MN method|||Non-inferiority of seroresponse of two vaccinations vs. one vaccination for age cohort (6 to 10 years of age) for MenA||21.3|1.7|
72530171|NCT01682876|144590276|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was demonstrated for 6 to 10 years of age group if the lower limit of the 2-sided 97.5% confidence interval (CI) for the difference in seroresponse rate between the 2-dose vaccination schedule and the 1-dose vaccination schedule (2-dose schedule minus the 1-dose schedule) was greater than -10% for MenC|Vaccines Group differences at Day 86|19.0|||||TWO_SIDED|97.5|9.9|29.2|||MN method|||Non-inferiority of seroresponse of two vaccinations vs. one vaccination for age cohort (6 to 10 years of age) for MenC||29.2|9.9|
72530172|NCT01682876|144590276|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was demonstrated for 6 to 10 years of age group if the lower limit of the 2-sided 97.5% confidence interval (CI) for the difference in seroresponse rate between the 2-dose vaccination schedule and the 1-dose vaccination schedule (2-dose schedule minus the 1-dose schedule) was greater than -10% for MenW|Vaccines Group Differences at Day 86|4.0|||||TWO_SIDED|97.5|-8.6|17.4|||MN method|||Non-inferiority of seroresponse of two vaccinations vs. one vaccination for age cohort (6 to 10 years of age) for MenW||17.4|-8.6|
72530173|NCT01682876|144590276|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was demonstrated for 6 to 10 years of age group if the lower limit of the 2-sided 97.5% confidence interval (CI) for the difference in seroresponse rate between the 2-dose vaccination schedule and the 1-dose vaccination schedule (2-dose schedule minus the 1-dose schedule) was greater than -10% for MenY|Vaccines Group Differences at Day 86|29.0|||||TWO_SIDED|97.5|18.4|40.0|||MN method|||Non-inferiority of seroresponse for two vaccinations vs. one vaccination for age cohort (6 to 10 years of age) for MenY||40|18.4|
72407924|NCT00094653|144324117|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.9||||0.0821|TWO_SIDED|95.0|-0.9|14.8|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Diarrhea change from baseline||14.8|-0.9|0.0821
72530174|NCT01682876|144590277|SUPERIORITY_OR_OTHER||Vaccine Group Differences at Day 86|18.0|||||TWO_SIDED|98.75|9.1|28.0|||MN method|||Superiority for age cohort (2 through 5 years of age) for MenA was demonstrated if the lower limit of the 2-sided (1-2α) % CI for seroresponse increase between the 2-dose vaccination schedule and the 1-dose vaccination schedule was above 10% for MenA||28|9.1|
72530175|NCT01682876|144590277|SUPERIORITY_OR_OTHER||Vaccine Group Differences at Day 86|28.0||||||98.75|17.1|38.7|||MN method|||Superiority for age cohort (2 through 5 years of age) for MenC was demonstrated if the lower limit of the 2-sided (1-2α) % CI for seroresponse increase between the 2-dose vaccination schedule and the 1-dose vaccination schedule was above 10% for MenC||38.7|17.1|
72530176|NCT01682876|144590277|SUPERIORITY_OR_OTHER||Vaccine Group differences at Day 86|14.0|||||TWO_SIDED|98.75|1.0|27.1|||MN method|||Superiority for age cohort (2 through 5 years of age) for MenW was demonstrated if the lower limit of the 2-sided (1-2α) % CI for seroresponse increase between the 2-dose vaccination schedule and the 1-dose vaccination schedule was above 10% for MenW||27.1|1|
72530177|NCT01682876|144590277|SUPERIORITY_OR_OTHER||Vaccine groups Differences at Day 86|28.0|||||TWO_SIDED|98.75|16.2|39.3|||MN method|||Superiority for age cohort (2 through 5 years of age) for MenY was demonstrated if the lower limit of the 2-sided (1-2α) % CI for seroresponse increase between the 2-dose vaccination schedule and the 1-dose vaccination schedule was above 10% for MenY||39.3|16.2|
72530178|NCT01682876|144590277|SUPERIORITY_OR_OTHER||Vaccine groups differences at Day 86|11.0|||||TWO_SIDED|98.75|1.0|21.2|||MN method|||Superiority for age cohort (6 through 10 years of age) for MenA was demonstrated if the lower limit of the 2-sided (1-2α) % CI for seroresponse increase between the 2-dose vaccination schedule and the 1-dose vaccination schedule was above 10% for MenA||21.2|1|
72530179|NCT01682876|144590277|SUPERIORITY_OR_OTHER||Vaccine Group differences at Day 86|18.0|||||TWO_SIDED|97.5|9.5|27.1|||MN method|||Superiority for age cohort (6 through 10 years of age) for MenC was demonstrated if the lower limit of the 2-sided (1-2α) % CI for seroresponse increase between the 2-dose vaccination schedule and the 1-dose vaccination schedule was above 10% for MenC||27.1|9.5|
72571952|NCT02912650|144671808|SUPERIORITY_OR_OTHER||LS Mean Difference|0.56||||0.024|TWO_SIDED|95.0|0.07|1.04|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.04|0.07|0.024
72530180|NCT01682876|144590277|SUPERIORITY_OR_OTHER||Vaccine Group Differences at Day 86|5.0|||||TWO_SIDED|98.75|-8.4|18.8|||MN method|||Superiority for age cohort (6 through 10 years of age) for MenW was demonstrated if the lower limit of the 2-sided (1-2α) % CI for seroresponse increase between the 2-dose vaccination schedule and the 1-dose vaccination schedule was above 10% for MenW||18.8|-8.4|
72530181|NCT01682876|144590277|SUPERIORITY_OR_OTHER||Vaccine group Differences at Day 86|29.0|||||TWO_SIDED|98.75|17.0|39.6|||MN method|||Superiority for age cohort (6 through 10 years of age) for MenY was demonstrated if the lower limit of the 2-sided (1-2α) % CI for seroresponse increase between the 2-dose vaccination schedule and the 1-dose vaccination schedule was above 10% for MenY||39.6|17|
72530182|NCT01682876|144590282|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|2.3|||||TWO_SIDED|95.0|1.17|4.53||||||The safety of two vaccine groups was compared by calculating risk ratio of the proportions of subjects who experienced erythema in the two doses versus in the one dose of MenACWY-CRM||4.53|1.17|
72530183|NCT01682876|144590282|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|2.75|||||TWO_SIDED|95.0|1.18|6.36||||||The safety of two vaccine groups was compared by calculating risk ratio of the proportions of subjects who experienced induration in the two doses versus in the one dose of MenACWY-CRM||6.36|1.18|
72530184|NCT01682876|144590282|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.07|||||TWO_SIDED|95.0|0.85|1.34||||||The safety of two vaccine groups was compared by calculating risk ratio of the proportions of subjects who experienced tenderness in the two doses versus in the one dose of MenACWY-CRM||1.34|0.85|
72530185|NCT01682876|144590282|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.88|||||TWO_SIDED|95.0|0.54|1.42||||||The safety of two vaccine groups was compared by calculating risk ratio of the proportions of subjects who experienced change in eating habits in the two doses versus in the one dose of MenACWY-CRM||1.42|0.54|
72530186|NCT01682876|144590282|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.08|||||TWO_SIDED|95.0|0.76|1.52||||||The safety of two vaccine groups was compared by calculating risk ratio of the proportions of subjects who experienced sleepiness in the two doses versus in the one dose of MenACWY-CRM||1.52|0.76|
72530187|NCT01682876|144590282|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.03|||||TWO_SIDED|95.0|0.74|1.43||||||The safety of two vaccine groups was compared by calculating risk ratio of the proportions of subjects who experienced irritability in the two doses versus in the one dose of MenACWY-CRM||1.43|0.74|
72530188|NCT01682876|144590282|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.75|||||TWO_SIDED|95.0|0.33|1.74||||||The safety of two vaccine groups was compared by calculating risk ratio of the proportions of subjects who experienced fever (≥38 °C) in the two doses versus in the one dose of MenACWY-CRM||1.74|0.33|
72530189|NCT01682876|144590283|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.43|||||TWO_SIDED|95.0|0.77|2.65||||||The safety of two vaccine groups was compared by calculating risk ratio of the proportions of subjects who experienced erythema in the two doses versus in the one dose of MenACWY-CRM||2.65|0.77|
72530190|NCT01682876|144590283|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.49|||||TWO_SIDED|95.0|0.81|2.74||||||The safety of two vaccine groups was compared by calculating risk ratio of the proportions of subjects who experienced induration in the two doses versus in the one dose of MenACWY-CRM||2.74|0.81|
72530191|NCT01682876|144590283|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.27|||||TWO_SIDED|95.0|1.04|1.55||||||The safety of two vaccine groups was compared by calculating risk ratio of the proportions of subjects who experienced pain in the two doses versus in the one dose of MenACWY-CRM||1.55|1.04|
72530192|NCT01682876|144590283|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.81|||||TWO_SIDED|95.0|0.98|3.33||||||The safety of two vaccine groups was compared by calculating risk ratio of the proportions of subjects who experienced loss of appetite in the two doses versus in the one dose of MenACWY-CRM||3.33|0.98|
72530193|NCT01682876|144590283|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.29|||||TWO_SIDED|95.0|0.77|2.17||||||The safety of two vaccine groups was compared by calculating risk ratio of the proportions of subjects who experienced nausea in the two doses versus in the one dose of MenACWY-CRM||2.17|0.77|
72530194|NCT01682876|144590283|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.65|||||TWO_SIDED|95.0|1.06|2.57||||||The safety of two vaccine groups was compared by calculating risk ratio of the proportions of subjects who experienced fatigue in the two doses versus in the one dose of MenACWY-CRM||2.57|1.06|
72530195|NCT01682876|144590283|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.37|||||TWO_SIDED|95.0|0.99|1.89||||||The safety of two vaccine groups was compared by calculating risk ratio of the proportions of subjects who experienced myalgia in the two doses versus in the one dose of MenACWY-CRM||1.89|0.99|
72530196|NCT01682876|144590283|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|2.07|||||TWO_SIDED|95.0|0.97|4.42||||||The safety of two vaccine groups was compared by calculating risk ratio of the proportions of subjects who experienced arthralgia in the two doses versus in the one dose of MenACWY-CRM||4.42|0.97|
72530197|NCT01682876|144590283|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.83|||||TWO_SIDED|95.0|1.22|2.74||||||The safety of two vaccine groups was compared by calculating risk ratio of the proportions of subjects who experienced headache in the two doses versus in the one dose of MenACWY-CRM||2.74|1.22|
72530198|NCT01682876|144590283|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.14|||||TWO_SIDED|95.0|0.48|2.68||||||The safety of two vaccine groups was compared by calculating risk ratio of the proportions of subjects who experienced fever (≥38 °C) in the two doses versus in the one dose of MenACWY-CRM||2.68|0.48|
72530199|NCT03852901|144590286|OTHER||Mean Difference (Final Values)|40.717|STANDARD_ERROR_OF_MEAN|4.866|<|0.001|TWO_SIDED|95.0|31.166|50.268||Type III of fixed effects. Num df = 1; Den df = 902.758; F = 70.003; Sig. \< 0.001 (threshold for statistical significance p \< 0.05)|Mixed Models Analysis|Random effect: ID; Repeated measures: Visit \& Timepoint; Fixed effects: Visit, Timepoint, Sex, Visit\*Sex||No a-priori power calculation was performed due to the exploratory nature of the study.||50.268|31.166|<0.001
72530200|NCT03852901|144590287|OTHER||Mean Difference (Final Values)|-0.637|STANDARD_ERROR_OF_MEAN|1.051||0.545|TWO_SIDED|95.0|-2.699|1.426||Type III of fixed effects. Num df = 1; Den df = 884.229; F = .367; Sig = .545 (threshold for statistical significance p \< 0.05)|Mixed Models Analysis|Random effect: ID; Repeated measures: Visit \& Timepoint; Fixed effects: Visit, Timepoint, Sex, Visit\*Sex||No a-priori power calculation was performed due to the exploratory nature of the study.||1.426|-2.699|0.545
72571953|NCT02912650|144671808|SUPERIORITY_OR_OTHER||LS Mean Difference|1.16|||<|0.001|TWO_SIDED|95.0|0.67|1.65|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.65|0.67|<0.001
72530201|NCT03852901|144590288|OTHER||Mean Difference (Final Values)|0.027|STANDARD_ERROR_OF_MEAN|0.009||0.003|TWO_SIDED|95.0|0.009|0.044||Type III of fixed effects. Num df = 1; Den df = 880.629; F = 8.782; Sig. = 0.003 (threshold for statistical significance p \< 0.05)|Mixed Models Analysis|Random effect: ID; Repeated measures: Visit \& Timepoint; Fixed effects: Visit, Timepoint, Sex, Visit\*Sex||No a-priori power calculation was performed due to the exploratory nature of the study.||.044|.009|0.003
72530202|NCT03852901|144590289|OTHER||Mean Difference (Final Values)|-2.647|STANDARD_ERROR_OF_MEAN|1.329||0.047|TWO_SIDED|95.0|-5.255|-0.04||Type III of fixed effects. Num df = 1; Den df = 880.870; F = 3.970; Sig. = 0.047 (threshold for statistical significance p \< 0.05)|Mixed Models Analysis|Random effect: ID; Repeated measures: Visit \& Timepoint; Fixed effects: Visit, Timepoint, Sex, Visit\*Sex||No a-priori power calculation was performed due to the exploratory nature of the study.||-0.040|-5.255|0.047
72530203|NCT03852901|144590290|OTHER||Mean Difference (Final Values)|-5.573|STANDARD_ERROR_OF_MEAN|1.853||0.003|TWO_SIDED|95.0|-9.21|-1.937||Type III of fixed effects. Num df = 1; Den df = 902.181; F = 9.049; Sig. = 0.003 (threshold for statistical significance p \< 0.05)|Mixed Models Analysis|Random effect: ID; Repeated measures: Visit \& Timepoint; Fixed effects: repeated-measures. Visit, Timepoint, Sex, Visit\*Sex||No a-priori power calculation was performed due to the exploratory nature of the study.||-1.937|-9.210|0.003
72530204|NCT03852901|144590291|OTHER|||||||0.5849||||||Type III of fixed effects. Num df: 2; Den df = 33; F = 0.5451; Sig. = 0.5849 (threshold for statistical significance p \< 0.05)|Mixed Models Analysis|Random effect: ID; Repeated measures: Visit; Fixed effects: Visit, Sex, Age, fCSF||No a-priori power calculation was performed due to the exploratory nature of the study.||||0.5849
72530205|NCT03852901|144590292|OTHER|||||||0.0142||||||Type III of fixed effects. Num df = 2; Den df = 35; F = 4.8191; Sig. = 0.0142 (threshold for statistical significance p \< 0.05)|Mixed Models Analysis|Random effect: ID; Repeated measures: Visit; Fixed effects: Visit, Sex, Age, fCSF||No a-priori power calculation was performed due to the exploratory nature of the study.||||0.0142
72530206|NCT03852901|144590293|OTHER|||||||0.024||||||Type III of fixed effects. Num df: 2; Den df = 34; F = 4.1501; Sig. = 0.0244 (threshold for statistical significance p \< 0.05)|Mixed Models Analysis|Random effects: ID; Repeated measures: Visit; Fixed effects: Visit, Sex, Age and fCSF||No a-priori power calculation was performed due to the exploratory nature of the study.||||0.024
72530207|NCT02534324|144590295|SUPERIORITY_OR_OTHER|||||||0.49|TWO_SIDED||||||Chi-squared|||||||0.49
72530208|NCT02534324|144590296|SUPERIORITY_OR_OTHER|||||||0.15|TWO_SIDED||||||t-test, 2 sided|||||||0.15
72530209|NCT01138995|144590297|SUPERIORITY_OR_OTHER|||||||0.75|TWO_SIDED||||||Fisher's combination test|Between group difference for entire sample||||||0.75
72530210|NCT01138995|144590298|SUPERIORITY_OR_OTHER||||||<|0.022|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<0.022
72530211|NCT01138995|144590299|SUPERIORITY_OR_OTHER||||||<|0.001|ONE_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<0.001
72530212|NCT04259749|144590311|OTHER||Odds Ratio (OR)|1.4|||||TWO_SIDED|95.0|0.58|3.4|||||Adjusted for age, education, lifetime use of tobacco products.|||3.40|0.58|
72530213|NCT04259749|144590311|OTHER||Odds Ratio (OR)|2.28|||||TWO_SIDED|95.0|0.92|5.63|||||Adjusted for age, education, and lifetime use of tobacco products|||5.63|0.92|
72530214|NCT04259749|144590312|OTHER||Odds Ratio (OR)|1.58|||||TWO_SIDED|95.0|0.61|4.07|||||Adjusted for age, education, and lifetime use of tobacco products|||4.07|0.61|
72530215|NCT04259749|144590312|OTHER||Odds Ratio (OR)|3.45|||||TWO_SIDED|95.0|1.32|9.02|||||Adjusted for age, education, and lifetime use of tobacco products|||9.02|1.32|
72530216|NCT04259749|144590313|OTHER||Odds Ratio (OR)|1.48|||||TWO_SIDED|95.0|0.59|3.68|||||Adjusted for age, education, and lifetime use of tobacco|||3.68|.59|
72530217|NCT04259749|144590313|OTHER||Odds Ratio (OR)|2.6|||||TWO_SIDED|95.0|1.05|6.42|||||Adjusted for age, education, and lifetime use of tobacco products.|||6.42|1.05|
72530218|NCT04259749|144590314|OTHER||Odds Ratio (OR)|1.08|||||TWO_SIDED|95.0|0.47|2.49|||||Adjusted for age, education, and lifetime use of tobacco|||2.49|.47|
72530219|NCT04259749|144590314|OTHER||Odds Ratio (OR)|1.43|||||TWO_SIDED|95.0|0.62|3.31|||||Adjusted for age, education, and lifetime use of tobacco products|||3.31|.62|
72530220|NCT04259749|144590315|OTHER||Odds Ratio (OR)|1.73|||||TWO_SIDED|95.0|0.72|4.14|||||Adjusted for age, education, and lifetime use of tobacco products|||4.14|.72|
72530221|NCT04259749|144590315|OTHER||Odds Ratio (OR)|2.03|||||TWO_SIDED|95.0|0.83|4.95|||||Adjusted for age, education, and lifetime use of tobacco products.|||4.95|.83|
72530222|NCT04259749|144590316|OTHER||Odds Ratio (OR)|1.13|||||TWO_SIDED|95.0|0.4|3.18|||||Adjusted for age, education, and lifetime tobacco use|||3.18|.40|
72530223|NCT04259749|144590316|OTHER||Odds Ratio (OR)|2.04|||||TWO_SIDED|95.0|0.73|5.71|||||Adjusted for age, education, and lifetime tobacco use|||5.71|.73|
72530224|NCT04259749|144590317|OTHER||Odds Ratio (OR)|1.77|||||TWO_SIDED|95.0|0.66|4.75|||||Adjusted for age, education, and lifetime tobacco use|||4.75|.66|
72530225|NCT04259749|144590317|OTHER||Odds Ratio (OR)|3.06|||||TWO_SIDED|95.0|1.13|8.29|||||Adjusted for age, education, and lifetime use of tobacco|||8.29|1.13|
72530226|NCT04259749|144590318|OTHER||Odds Ratio (OR)|1.38|||||TWO_SIDED|95.0|0.51|3.7|||||Adjusted for age, education, and lifetime tobacco use|||3.70|.51|
72530227|NCT04259749|144590318|OTHER||Odds Ratio (OR)|2.32|||||TWO_SIDED|95.0|0.85|6.31|||||Adjusted for age, education, and lifetime tobacco use|||6.31|.85|
72530228|NCT04259749|144590319|OTHER||Odds Ratio (OR)|1.11|||||TWO_SIDED|95.0|0.29|4.26|||||Adjusted for age, education, and lifetime tobacco use|||4.26|.29|
72530229|NCT04259749|144590319|OTHER||Odds Ratio (OR)|2.0|||||TWO_SIDED|95.0|0.57|7.06|||||Adjusted for age, education, and lifetime tobacco use|||7.06|.57|
72530230|NCT04259749|144590320|OTHER||Odds Ratio (OR)|1.04|||||TWO_SIDED|95.0|0.33|3.31|||||Adjusted for age, education, and lifetime tobacco use|||3.31|.33|
72530231|NCT04259749|144590320|OTHER||Odds Ratio (OR)|2.43|||||TWO_SIDED|0.95|0.83|7.13|||||Adjusted for age, education, and lifetime tobacco use|||7.13|.83|
72530232|NCT04259749|144590321|OTHER||Odds Ratio (OR)|1.73|||||TWO_SIDED|95.0|0.72|4.14|||||Adjusted for age, education, and lifetime tobacco use|||4.14|.72|
72628217|NCT00492557|144784517|NON_INFERIORITY_OR_EQUIVALENCE|The criterion upon which to declare non-inferiority was if the lower limit of the 2-sided 95%CI for the GMT ratios, (13vPnC+TIV relative to 13vPnC administered 1 month after TIV+placebo) was greater than 0.5 (2-fold criterion).|GMT Ratio|0.7|||||TWO_SIDED|95.0|0.47|0.95|||||2-sided 95% CIs for the GMT ratio were calculated by back transformations of the 95% CIs based on the Student t distribution for the mean difference of the logarithmically transformed assay results.|Serotype 4. The primary null hypothesis was: the log of the GMT in the group receiving 13vPnC + TIV minus the log of the GMT in the group receiving 13vPnC alone (1 month after TIV) \<= -0.693.||0.95|0.47|
72530233|NCT04259749|144590321|OTHER||Odds Ratio (OR)|2.03|||||TWO_SIDED|95.0|0.83|4.95|||||Adjusted for age, education, and lifetime tobacco use|||4.95|.83|
72530234|NCT00303602|144590322|SUPERIORITY_OR_OTHER|||||||0.428||95.0||||P-value for Week 2 Change from Baseline. There was no adjustment for multiple comparisons.|Mixed Models Analysis|||||||0.428
72530235|NCT00303602|144590322|SUPERIORITY_OR_OTHER|||||||0.859||95.0||||P-value for Week 4 Change from Baseline. There was no adjustment for multiple comparisons.|Mixed Models Analysis|||||||0.859
72530236|NCT00303602|144590322|SUPERIORITY_OR_OTHER|||||||0.885||95.0||||P-value for Week 8 Change from Baseline. There was no adjustment for multiple comparisons.|Mixed Models Analysis|||||||0.885
72530237|NCT00303602|144590322|SUPERIORITY_OR_OTHER|||||||0.784||95.0||||P-value for Week 12 Change from Baseline. There was no adjustment for multiple comparisons.|Mixed Models Analysis|||||||0.784
72530238|NCT00303602|144590322|SUPERIORITY_OR_OTHER|||||||0.465||95.0||||P-value for Week 16 Change from Baseline. There was no adjustment for multiple comparisons|Mixed Models Analysis|||||||0.465
72530239|NCT00303602|144590323|SUPERIORITY_OR_OTHER||Least Square Mean Change Difference|-0.19||||0.442||95.0|-0.67|0.3|||ANCOVA||Change = Endpoint minus baseline|||0.30|-0.67|0.442
72530240|NCT00303602|144590324|SUPERIORITY_OR_OTHER||Least Square Mean Change Difference|-0.32||||0.328||95.0|-0.95|0.32|||ANCOVA||Change = Endpoint minus baseline|||0.32|-0.95|0.328
72530241|NCT00303602|144590325|SUPERIORITY_OR_OTHER|||||||0.385||95.0|||||Mixed Models Analysis|||||||0.385
72530242|NCT00303602|144590326|SUPERIORITY_OR_OTHER||Least Square Mean Change Difference|0.1||||0.914||95.0|-1.65|1.84|||ANCOVA||Change = endpoint minus baseline|||1.84|-1.65|0.914
72530243|NCT00303602|144590327|SUPERIORITY_OR_OTHER|||||||0.325||95.0||||Up to Week 16 p-value|Fisher Exact|||||||0.325
72530244|NCT00303602|144590329|SUPERIORITY_OR_OTHER|||||||0.344||95.0|||||Mixed Models Analysis|||||||0.344
72530245|NCT00303602|144590330|SUPERIORITY_OR_OTHER|||||||0.708||95.0||||Systolic Blood Pressure Change to Endpoint p-value|Rank-Sum Test|||||||0.708
72530246|NCT00303602|144590330|SUPERIORITY_OR_OTHER|||||||0.453||95.0||||Diastolic Blood Pressure Change to Endpoint p-value|Rank-Sum Test|||||||0.453
72530247|NCT00303602|144590331|SUPERIORITY_OR_OTHER|||||||0.187||95.0||||Total Cholesterol Change to Endpoint p-value|Cochran-Mantel-Haenszel|Ranks of change from baseline were regressed on ranks of baseline value of assay. Treatments compared using residuals of this regression in CMH test.||||||0.187
72530248|NCT00303602|144590331|SUPERIORITY_OR_OTHER|||||||0.163||95.0||||High-Density Lipoprotein Cholesterol Change to Endpoint p-value|Cochran-Mantel-Haenszel|Ranks of change from baseline were regressed on ranks of baseline value of assay. Treatments compared using residuals of this regression in CMH test.||||||0.163
72530249|NCT00303602|144590331|SUPERIORITY_OR_OTHER|||||||0.323||95.0||||Low-Density Lipoprotein Cholesterol Change to Endpoint p-value|Cochran-Mantel-Haenszel|Ranks of change from baseline were regressed on ranks of baseline value of assay. Treatments compared using residuals of this regression in CMH test.||||||0.323
72530250|NCT00303602|144590331|SUPERIORITY_OR_OTHER|||||||0.581||95.0||||Triglycerides Change to Endpoint p-value|Cochran-Mantel-Haenszel|Ranks of change from baseline were regressed on ranks of baseline value of assay. Treatments compared using residuals of this regression in CMH test.||||||0.581
72530251|NCT00303602|144590332|SUPERIORITY_OR_OTHER|||||||0.227||95.0|||||Cochran-Mantel-Haenszel|Ranks of change from baseline were regressed on ranks of baseline value of assay. Treatments compared using residuals of this regression in CMH test.||||||0.227
72530252|NCT00303602|144590333|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||Cochran-Mantel-Haenszel|Ranks of change from baseline were regressed on ranks of baseline value of assay. Treatments compared using residuals of this regression in CMH test.||||||0.020
72530253|NCT00303602|144590334|SUPERIORITY_OR_OTHER|||||||0.834||95.0|||||Cochran-Mantel-Haenszel|Ranks of change from baseline were regressed on ranks of baseline value of assay. Treatments compared using residuals of this regression in CMH test.||||||0.834
72530254|NCT00303602|144590335|SUPERIORITY_OR_OTHER|||||||0.022||95.0|||||Cochran-Mantel-Haenszel|Ranks of change from baseline were regressed on ranks of baseline value of assay. Treatments compared using residuals on this regression in CMH test.||||||0.022
72530255|NCT00303602|144590336|SUPERIORITY_OR_OTHER|||||||0.515||95.0||||Endpoint Metabolic Syndrome p-value|Fisher Exact|||||||0.515
72530256|NCT00303602|144590337|SUPERIORITY_OR_OTHER|||||||0.118||95.0|||||Mixed Models Analysis|||||||0.118
72530257|NCT00303602|144590338|SUPERIORITY_OR_OTHER|||||||0.161||95.0|||||Mixed Models Analysis|||||||0.161
72530258|NCT00303602|144590339|SUPERIORITY_OR_OTHER|||||||0.229||95.0|||||Mixed Models Analysis|||||||0.229
72530259|NCT01491802|144590369|SUPERIORITY|||||||0.09|||||||t-test, 2 sided|||A paired t-test using a 2-sided test of significance was used to compare values after LAMA versus LABA/LAMA treatment.||||0.090
72530260|NCT01491802|144590370|SUPERIORITY|||||||0.68|||||||t-test, 2 sided|||A paired t-test using a 2-sided test of significance was used to compare values after LAMA versus LABA/LAMA treatment.||||0.680
72530261|NCT01491802|144590371|SUPERIORITY|||||||0.197|||||||t-test, 2 sided|||A paired t-test using a 2-sided test of significance was used to compare values after LAMA versus LABA/LAMA treatment.||||0.197
72530262|NCT01491802|144590372|SUPERIORITY|||||||0.006|||||||t-test, 2 sided|||A paired t-test using a 2-sided test of significance was used to compare values after LAMA versus LABA/LAMA treatment.||||0.006
72530263|NCT01491802|144590373|SUPERIORITY|||||||0.044|||||||t-test, 2 sided|||A paired t-test using a 2-sided test of significance was used to compare values after LAMA versus LABA/LAMA treatment.||||0.044
72530264|NCT01491802|144590374|SUPERIORITY|||||||0.573|||||||t-test, 2 sided|||A paired t-test using a 2-sided test of significance was used to compare values after LAMA versus LABA/LAMA treatment.||||0.573
72530265|NCT01491802|144590375|SUPERIORITY|||||||0.96|||||||t-test, 2 sided|||A paired t-test using a 2-sided test of significance was used to compare values after LAMA versus LABA/LAMA treatment.||||0.960
72407925|NCT00094653|144324117|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.6||||0.4169|TWO_SIDED|95.0|-9.0|3.8|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Diarrhea change from baseline||3.8|-9.0|0.4169
72530266|NCT01491802|144590376|SUPERIORITY|||||||0.944|||||||t-test, 2 sided|||A paired t-test using a 2-sided test of significance was used to compare values after LAMA versus LABA/LAMA treatment.||||0.944
72530267|NCT01491802|144590377|SUPERIORITY|||||||0.028|||||||t-test, 2 sided|||A paired t-test using a 2-sided test of significance was used to compare values after LAMA versus LABA/LAMA treatment.||||0.028
72530268|NCT03993314|144590379|SUPERIORITY|||||||0.757||||||Two-sided p-value|Farrington-Manning (Score) test|||Exact Farrington-Manning (Score) test of the null hypothesis that there is no difference between the proportion of patients achieving a level of numbness of T6 or higher between the two groups.||||0.757
72530269|NCT03993314|144590380|SUPERIORITY|||||||0.186||||||Two-sided p-value|Wilcoxon (Mann-Whitney)|Test performed was an exact test; no continuity correction was used.||Exact Wilcoxon test of the null hypothesis that there is no difference between the median level of numbness between the two groups.||||0.186
72530270|NCT03993314|144590381|SUPERIORITY|||||||0.132||||||Two-sided p-value|Farrington-Manning (Score) test|||Exact Farrington-Manning (Score) test of the null hypothesis that there is no difference between the proportion of patients requiring epidural activation between the two groups.||||0.132
72530271|NCT03993314|144590382|SUPERIORITY|||||||0.833||||||Two-sided p-value|Farrington-Manning (Score) test|||Exact Farrington-Manning (Score) test of the null hypothesis that there is no difference between the proportion of patients requiring supplemental IV sedation or general anesthesia between the two groups.||||0.833
72530272|NCT03993314|144590383|SUPERIORITY|||||||0.004||||||Two-sided p-value|Wilcoxon (Mann-Whitney)|Test performed was an exact test; no continuity correction was used.||Exact Wilcoxon test of the null hypothesis that there is no difference between the median modified Bromage score between the two groups.||||0.004
72407926|NCT00094653|144324117|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.7||||0.5717|TWO_SIDED|95.0|-7.5|4.2|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Financial Impact change from baseline||4.2|-7.5|0.5717
72530273|NCT03993314|144590384|SUPERIORITY|||||||0.674||||||Two-sided p-value|Wilcoxon (Mann-Whitney)|Test performed was an exact test; no continuity correction was used.||Exact Wilcoxon test of the null hypothesis that there is no difference between the median modified Bromage score between the two groups.||||0.674
72530274|NCT03993314|144590385|SUPERIORITY|||||||0.196|||||||Log Rank|||Log-rank test of the null hypothesis that there is no difference in the time to discharge from the Post Anesthesia Care Unit (PACU) between the two groups.||||0.196
72530275|NCT03287960|144590539|OTHER|Two-sided confidence interval obtained using Clopper-Pearson method and one-sided p-value obtained from exact binomial test, testing that at least 5% of participants in the population of interest will achieve 10% weight loss.||||||0.0001|||||||Clopper-Pearson method|||||||0.0001
72530276|NCT03287960|144590540|OTHER|Two-sided confidence interval (CI) obtained using Clopper-Pearson method and one-sided p-value obtained from exact binomial test, testing that at least 5% of patients in the population of interest would achieve 10% weight loss.|||||<|0.0001|||||||Clopper-Pearson method|||||||<0.0001
72530277|NCT03287960|144590541|OTHER|Model based summary statistics from longitudinal mixed analysis of variance (ANOVA) model with fixed effect for visit, baseline body weight and random effect for participant, one sided p-value from model.|Least Squares Mean|-12.37|||<|0.0001|TWO_SIDED|90.0|-15.08|-9.66|||ANOVA|Longitudinal mixed ANOVA||||-9.66|-15.08|<.0001
72530278|NCT03287960|144590542|OTHER|Model based summary statistics from longitudinal mixed analysis of variance model with fixed effect for week, baseline daily hunger score and random effect for participant, one sided p-value from model.|Least Squares Mean|-42.69|||<|0.0001|TWO_SIDED|90.0|-56.35|-29.02|||ANOVA|Longitudinal mixed analysis of variance (ANOVA) model||||-29.02|-56.35|<.0001
72530279|NCT03287960|144590543|OTHER|Two-sided CI obtained using Clopper-Pearson method and one-sided p-value obtained from exact binomial test, testing that ≥5 % of participants in the population of interest would achieve ≥25 % improvement in daily hunger score.|||||<|0.0001|||||||Clopper-Pearson method|||||||<.0001
72530280|NCT03287960|144590544|OTHER|Model based summary statistics from longitudinal mixed analysis of variance model with fixed effect for visit, baseline waist circumference and random effect for participant, one sided p-value from model.|Least Squares Mean|-8.9||||0.0031|TWO_SIDED|90.0|-14.1|-3.61|||ANOVA|Longitudinal mixed ANOVA||||-3.61|-14.10|0.0031
72530281|NCT03287960|144590547|OTHER|Model based summary statistics from longitudinal mixed analysis of variance model with fixed effect for week, baseline BMI and random effect for participant, one sided p-value from model.|Least Squares Mean|-14.0|||<|0.0001|TWO_SIDED|90.0|-16.8|-11.2|||ANOVA|Longitudinal mixed ANOVA model||||-11.20|-16.80|<.0001
72530282|NCT02600715|144590558|EQUIVALENCE|Test for differences in continuous variables.||||||0.94||||||Two-sided alpha of 0.05 was used to determine statistical significance.|Kruskal-Wallis|||||||0.94
72530283|NCT00612573|144590568|SUPERIORITY_OR_OTHER||Mean Change from Baseline|-0.75|STANDARD_DEVIATION|0.85||0.779|TWO_SIDED|95.0|-14.8|10.3|||Cochran-Mantel-Haenszel|Stratified by Investigational Site||||10.3|-14.8|0.779
72530284|NCT00612573|144590568|SUPERIORITY_OR_OTHER||Mean Change from Baseline|-0.69|STANDARD_DEVIATION|0.9||0.983|TWO_SIDED|95.0|-13.7|11.7|||Cochran-Mantel-Haenszel|Stratified by Investigational Site||||11.7|-13.7|0.983
72530285|NCT00612573|144590568|SUPERIORITY_OR_OTHER||Mean Change from Baseline|-0.92|STANDARD_DEVIATION|0.97||0.087|TWO_SIDED|95.0|-1.5|27.3|||Cochran-Mantel-Haenszel|Stratified by Investigational Site||||27.3|-1.5|0.087
72530286|NCT00612573|144590569|SUPERIORITY_OR_OTHER|||||||0.807||95.0|||||Cochran-Mantel-Haenszel|Stratified by Investigational Site||||||0.807
72530287|NCT00612573|144590569|SUPERIORITY_OR_OTHER|||||||0.075||95.0|||||Cochran-Mantel-Haenszel|Stratified by Investigational Site||||||0.075
72530288|NCT00612573|144590569|SUPERIORITY_OR_OTHER|||||||0.039||95.0|||||Cochran-Mantel-Haenszel|Stratified by Investigational Site||||||0.039
72530289|NCT00612573|144590570|SUPERIORITY_OR_OTHER|||||||0.212||95.0|||||Cochran-Mantel-Haenszel|Stratified by Investigational Site||||||0.212
72530290|NCT00612573|144590570|SUPERIORITY_OR_OTHER|||||||0.505||95.0|||||Cochran-Mantel-Haenszel|Stratified by Investigational Site||||||0.505
72625639|NCT05715827|144780635|OTHER|Descriptive statistics will be used, presenting frequency, percentage, and 95% confidence intervals for each secondary endpoint: overall complication rate, major complication rate, readmission rate, reoperation rate, and Device Deficiencies (DD) rate through 30 days post-surgery. Secondary endpoints will be assessed overall and by surgery type (prostatectomy and cholecystectomy).|Device deficiency rate|32.5|||||TWO_SIDED|95.0|18.6|49.1||Descriptive statistics and estimated rates were used. P-values were not calculated for secondary endpoints.||||The secondary objective is to assess the short-term safety outcome of the Medtronic Hugo™ RAS System when used for prostatectomy or cholecystectomy. Overall complication rate through 30-day post-surgery: A proportion of subjects with any postoperative complication within 30-days post-surgery using the investigational device||49.1|18.6|
72530291|NCT00612573|144590570|SUPERIORITY_OR_OTHER|||||||0.399||95.0|||||Cochran-Mantel-Haenszel|Stratified by Investigational Site||||||0.399
72530292|NCT00612573|144590571|SUPERIORITY_OR_OTHER|||||||0.276||95.0|||||Cochran-Mantel-Haenszel|Stratified by Investigational Site||||||0.276
72530293|NCT00612573|144590571|SUPERIORITY_OR_OTHER|||||||0.231||95.0|||||Cochran-Mantel-Haenszel|Stratified by Investigational Site||||||0.231
72530294|NCT00612573|144590571|SUPERIORITY_OR_OTHER|||||||0.081||95.0|||||Cochran-Mantel-Haenszel|Stratified by Investigational Site||||||0.081
72530295|NCT01425268|144590582|NON_INFERIORITY|Assuming that the success rate for both expanders was 95%, at least 92 breasts implanted with a AeroForm Tissue Expander and 46 breasts implanted with a saline expander were needed to be 80% confident (i.e., have a statistical power of 80%) that the lower bound of the one-sided 95% Confidence Interval for the difference in the Success rates (πTreatment - πControl) was greater than or equal to -10%.|margin of non-inferiority|-7.3|||||ONE_SIDED|95.0|-7.3241||||||The Treatment Success Rate per breast is 96.1% (149/155) for AeroForm and 98.8% (82/83) for saline.The difference (AeroForm - saline) is -2.7% with a lower confidence limit of -7.3%, meeting the non-inferiority margin of \> -10%.|The study was powered to show that the Treatment Success rate for the AeroForm System (πTreatment) was not worse than the rate for the saline expander (πControl) by more than 10% (-0.10 \< πTreatment - πControl).|||-7.3241|
72530296|NCT01425268|144590583|SUPERIORITY||||||<|0.0001|||||||Kaplan-Meier Log Rank test|Subjects not completing tissue expansion are censored in the analysis||||||<0.0001
72625640|NCT03021486|144780676|OTHER|||||||0.71|||||||Wilcoxon Rank Sum Test|||||||0.71
72530297|NCT02516605|144590585|OTHER||adjusted fold change from baseline|0.86||||0.293|TWO_SIDED|90.0|0.68|1.09|||ANCOVA|||||1.09|0.68|0.293
72530298|NCT02516605|144590585|OTHER||adjusted fold change from baseline|0.47|||<|0.001|TWO_SIDED|90.0|0.37|0.6|||ANCOVA|||||0.60|0.37|<0.001
72530299|NCT02516605|144590585|OTHER||adjusted fold change from baseline|0.32|||<|0.001|TWO_SIDED|90.0|0.26|0.4|||ANCOVA|||||0.40|0.26|<.001
72530300|NCT02516605|144590585|OTHER||adjusted fold change from baseline|0.36|||<|0.001|TWO_SIDED|90.0|0.27|0.47|||ANCOVA|||||0.47|0.27|<.001
72530301|NCT02516605|144590595|OTHER||Median difference from baseline|1.0||||0.898|TWO_SIDED|90.0|-7.0|6.0|||Wilcoxon rank-sum test|Day 28||||6.0|-7.0|0.898
72530302|NCT02516605|144590595|OTHER||Median difference from baseline|2.0||||0.593|TWO_SIDED|90.0|-4.0|10.0|||Wilcoxon rank-sum test|Day 56||||10.0|-4.0|0.593
72530303|NCT02516605|144590595|OTHER||Median difference from baseline|-3.0||||0.509|TWO_SIDED|90.0|-11.0|4.0|||Wilcoxon rank-sum test|Day 84||||4.0|-11.0|0.509
72530304|NCT02516605|144590595|OTHER||Median difference from baseline|1.5||||0.591|TWO_SIDED|90.0|-5.0|7.0|||Wilcoxon rank-sum test|Day 28||||7.0|-5.0|0.591
72530305|NCT02516605|144590595|OTHER||Median difference from baseline|-2.0||||0.702|TWO_SIDED|90.0|-12.0|4.0|||Wilcoxon rank-sum test|Day 56||||4.0|-12.0|0.702
72530306|NCT02516605|144590595|OTHER||Median difference from baseline|-1.0||||0.838|TWO_SIDED|90.0|-10.0|8.0|||Wilcoxon rank-sum test|Day 84||||8.0|-10.0|0.838
72530307|NCT02516605|144590595|OTHER||Median difference from baseline|4.0||||0.297|TWO_SIDED|90.0|-3.0|8.0|||Wilcoxon rank-sum test|Day 28||||8.0|-3.0|0.297
72530308|NCT02516605|144590595|OTHER||Median difference from baseline|-6.0||||0.236|TWO_SIDED|90.0|-14.0|1.0|||Wilcoxon rank-sum test|Day 56||||1.0|-14.0|0.236
72530309|NCT02516605|144590595|OTHER||Median difference from baseline|-6.5||||0.192|TWO_SIDED|90.0|-15.0|1.0|||Wilcoxon rank-sum test|Day 84||||1.0|-15.0|0.192
72530310|NCT02516605|144590595|OTHER||Median difference from baseline|2.0||||0.605|TWO_SIDED|90.0|-2.0|9.0|||Wilcoxon rank-sum test|Day 28||||9.0|-2.0|0.605
72530311|NCT02516605|144590595|OTHER||Median difference from baseline|-11.0||||0.037|TWO_SIDED|90.0|-21.0|-1.0|||Wilcoxon rank-sum test|Day 56||||-1.0|-21.0|0.037
72530312|NCT02516605|144590595|OTHER||Median difference from baseline|-3.5||||0.397|TWO_SIDED|90.0|-11.0|3.0|||Wilcoxon rank-sum test|Day 84||||3.0|-11.0|0.397
72530313|NCT02516605|144590596|OTHER||Median difference from baseline|1.0||||0.342|TWO_SIDED|90.0|-1.0|2.0|||Wilcoxon rank-sum test|Day 28||||2.0|-1.0|0.342
72530314|NCT02516605|144590596|OTHER||Median difference from baseline|0.0||||0.699|TWO_SIDED|90.0|-1.0|2.0|||Wilcoxon rank-sum test|Day 56||||2.0|-1.0|0.699
72530315|NCT02516605|144590596|OTHER||Median difference from baseline|-1.0||||0.377|TWO_SIDED|90.0|-3.0|0.0|||Wilcoxon rank-sum test|Day 84||||0.0|-3.0|0.377
72530316|NCT02516605|144590596|OTHER||Median difference from baseline|1.0||||0.132|TWO_SIDED|90.0|0.0|2.0|||Wilcoxon rank-sum test|Day 28||||2.0|0.0|0.132
72530317|NCT02516605|144590596|OTHER||Median difference from baseline|1.0||||0.292|TWO_SIDED|90.0|0.0|2.0|||Wilcoxon rank-sum test|Day 56||||2.0|0.0|0.292
72530318|NCT02516605|144590596|OTHER||Median difference from baseline|0.0||||0.979|TWO_SIDED|90.0|-2.0|1.0|||Wilcoxon rank-sum test|Day 84||||1.0|-2.0|0.979
72530319|NCT02516605|144590596|OTHER||Median difference from baseline|2.0||||0.102|TWO_SIDED|90.0|0.0|4.0|||Wilcoxon rank-sum test|Day 28||||4.0|0.0|0.102
72530320|NCT02516605|144590596|OTHER||Median difference from baseline|0.0||||0.717|TWO_SIDED|90.0|-1.0|2.0|||Wilcoxon rank-sum test|Day 56||||2.0|-1.0|0.717
72530321|NCT02516605|144590596|OTHER||Median difference|0.0||||1|TWO_SIDED|90.0|-2.0|1.0|||Wilcoxon rank-sum test|Day 84||||1.0|-2.0|1.000
72530322|NCT02516605|144590596|OTHER||Median difference from baseline|2.0||||0.142|TWO_SIDED|90.0|0.0|5.0|||Wilcoxon rank-sum test|Day 28||||5.0|0.0|0.142
72530323|NCT02516605|144590596|OTHER||Median difference from baseline|0.0||||0.975|TWO_SIDED|90.0|-1.0|1.0|||Wilcoxon rank-sum test|Day 56||||1.0|-1.0|0.975
72530324|NCT02516605|144590596|OTHER||Median difference from baseline|0.0||||0.602|TWO_SIDED|90.0|-2.0|1.0|||Wilcoxon rank-sum test|Day 84||||1.0|-2.0|0.602
72530325|NCT02516605|144590597|OTHER||Mean difference from baseline|-2.78|STANDARD_ERROR_OF_MEAN|8.436||0.743|TWO_SIDED|90.0|-16.91|11.34|||ANCOVA|Day 7||||11.34|-16.91|0.743
72571954|NCT02912650|144671808|SUPERIORITY_OR_OTHER||LS Mean Difference|1.23|||<|0.001|TWO_SIDED|95.0|0.54|1.92|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.92|0.54|<0.001
72571955|NCT02912650|144671808|SUPERIORITY_OR_OTHER||LS Mean Difference|0.62||||0.079|TWO_SIDED|95.0|-0.07|1.32|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.32|-0.07|0.079
72571956|NCT02912650|144671808|SUPERIORITY_OR_OTHER||LS Mean Difference|0.6||||0.015|TWO_SIDED|95.0|0.12|1.09|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.09|0.12|0.015
72625641|NCT03021486|144780678|OTHER|||||||0.86|||||||Wilcoxon Rank Sum Test|||||||0.86
72530326|NCT02516605|144590597|OTHER||Median difference from baseline|-14.07|STANDARD_ERROR_OF_MEAN|8.229||0.093|TWO_SIDED|90.0|-27.85|-0.28|||ANCOVA|Day 14||||-0.28|-27.85|0.093
72530327|NCT02516605|144590597|OTHER||Median difference from baseline|7.78|STANDARD_ERROR_OF_MEAN|8.71||0.376|TWO_SIDED|90.0|-6.81|22.38|||ANCOVA|Day 21||||22.38|-6.81|0.376
72530328|NCT02516605|144590597|OTHER||Median difference from baseline|7.03|STANDARD_ERROR_OF_MEAN|9.187||0.448|TWO_SIDED|90.0|-8.36|22.43|||ANCOVA|Day 28||||22.43|-8.36|0.448
72571957|NCT02912650|144671808|SUPERIORITY_OR_OTHER||LS Mean Difference|1.25|||<|0.001|TWO_SIDED|95.0|0.56|1.94|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.94|0.56|<0.001
72571958|NCT02912650|144671808|SUPERIORITY_OR_OTHER||LS Mean Difference|0.19||||0.438|TWO_SIDED|95.0|-0.29|0.67|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.67|-0.29|0.438
72571959|NCT02912650|144671808|SUPERIORITY_OR_OTHER||LS Mean Difference|0.8||||0.001|TWO_SIDED|95.0|0.31|1.29|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.29|0.31|0.001
72571960|NCT02912650|144671808|SUPERIORITY_OR_OTHER||LS Mean Difference|1.06||||0.003|TWO_SIDED|95.0|0.37|1.75|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.75|0.37|0.003
72530329|NCT02516605|144590597|OTHER||Median difference from baseline|-15.25|STANDARD_ERROR_OF_MEAN|7.192||0.039|TWO_SIDED|90.0|-27.3|-3.19|||ANCOVA|Day 56||||-3.19|-27.30|0.039
72530330|NCT02516605|144590597|OTHER||Median difference from baseline|-16.93|STANDARD_ERROR_OF_MEAN|8.592||0.054|TWO_SIDED|90.0|-31.31|-2.54|||ANCOVA|Day 84||||-2.54|-31.31|0.054
72530331|NCT02516605|144590597|OTHER||Median difference from baseline|11.34|STANDARD_ERROR_OF_MEAN|8.434||0.185|TWO_SIDED|90.0|-2.78|25.46|||ANCOVA|Day 7||||25.46|-2.78|0.185
72530332|NCT02516605|144590597|OTHER||Median difference from baseline|7.74|STANDARD_ERROR_OF_MEAN|8.226||0.351|TWO_SIDED|90.0|-6.05|21.52|||ANCOVA|Day 14||||21.52|-6.05|0.351
72571961|NCT02912650|144671808|SUPERIORITY_OR_OTHER||LS Mean Difference|0.45||||0.204|TWO_SIDED|95.0|-0.25|1.14|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.14|-0.25|0.204
72571962|NCT02912650|144671808|SUPERIORITY_OR_OTHER||LS Mean Difference|0.61||||0.014|TWO_SIDED|95.0|0.12|1.1|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.10|0.12|0.014
72625642|NCT03021486|144780679|OTHER|||||||0.12|||||||Two-tailed Fisher's exact test|||||||0.12
72530333|NCT02516605|144590597|OTHER||Median difference from baseline|16.79|STANDARD_ERROR_OF_MEAN|8.707||0.059|TWO_SIDED|90.0|2.2|31.38|||ANCOVA|day 21||||31.38|2.20|0.059
72530334|NCT02516605|144590597|OTHER||Median difference from baseline|14.05|STANDARD_ERROR_OF_MEAN|9.184||0.132|TWO_SIDED|90.0|-1.35|29.44|||ANCOVA|Day 28||||29.44|-1.35|0.132
72530335|NCT02516605|144590597|OTHER||Median difference from baseline|-1.75|STANDARD_ERROR_OF_MEAN|7.19||0.809|TWO_SIDED|90.0|-13.8|10.31|||ANCOVA|Day 56||||10.31|-13.80|0.809
72530336|NCT02516605|144590597|OTHER||Median difference from baseline|-10.9|STANDARD_ERROR_OF_MEAN|8.59||0.21|TWO_SIDED|90.0|-25.29|3.48|||ANCOVA|Day 84||||3.48|-25.29|0.210
72530337|NCT02516605|144590597|OTHER||Median difference from baseline|13.92|STANDARD_ERROR_OF_MEAN|7.963||0.086||90.0|0.58|27.25|||ANCOVA|day 7||||27.25|0.58|0.086
72530338|NCT02516605|144590597|OTHER||Median difference from baseline|0.48|STANDARD_ERROR_OF_MEAN|7.787||0.951|TWO_SIDED|90.0|-12.57|13.53|||ANCOVA|Day 14||||13.53|-12.57|0.951
72530339|NCT02516605|144590597|OTHER||Median difference from baseline|5.02|STANDARD_ERROR_OF_MEAN|8.244||0.545|TWO_SIDED|90.0|-8.79|18.83|||ANCOVA|day 21||||18.83|-8.79|0.545
72530340|NCT02516605|144590597|OTHER||Median difference from baseline|0.19|STANDARD_ERROR_OF_MEAN|8.697||0.982|TWO_SIDED|90.0|-14.38|14.77|||ANCOVA|Day 28||||14.77|-14.38|0.982
72571963|NCT02912650|144671808|SUPERIORITY_OR_OTHER||LS Mean Difference|0.84||||0.018|TWO_SIDED|95.0|0.15|1.53|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.53|0.15|0.018
72571964|NCT02912650|144671808|SUPERIORITY_OR_OTHER||LS Mean Difference|0.04||||0.867|TWO_SIDED|95.0|-0.44|0.52|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.52|-0.44|0.867
72571965|NCT02912650|144671808|SUPERIORITY_OR_OTHER||LS Mean Difference|0.41||||0.099|TWO_SIDED|95.0|-0.08|0.9|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.90|-0.08|0.099
72571966|NCT02912650|144671808|SUPERIORITY_OR_OTHER||LS Mean Difference|0.8||||0.024|TWO_SIDED|95.0|0.11|1.49|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.49|0.11|0.024
72571967|NCT02912650|144671808|SUPERIORITY_OR_OTHER||LS Mean Difference|0.43||||0.228|TWO_SIDED|95.0|-0.27|1.12|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.12|-0.27|0.228
72571968|NCT02912650|144671808|SUPERIORITY_OR_OTHER||LS Mean Difference|0.37||||0.136|TWO_SIDED|95.0|-0.12|0.86|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.86|-0.12|0.136
72625643|NCT03021486|144780680|OTHER|||||||0.007|||||||Two-tailed Fisher's exact test|||||||0.007
72625644|NCT03021486|144780681|OTHER|||||||0.83|||||||Two-tailed Fisher's exact test|||Perceived Comfort level as assessed by caregiver||||0.83
72625645|NCT03021486|144780681|OTHER|||||||0.82|||||||Two-tailed Fisher's exact test|||Perceived agitation level as assessed by caregiver||||0.82
72407927|NCT00094653|144324117|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.4||||0.6949|TWO_SIDED|95.0|-5.6|8.4|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Financial Impact change from baseline||8.4|-5.6|0.6949
72407928|NCT00094653|144324117|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.1||||0.2849|TWO_SIDED|95.0|-8.8|2.6|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Financial Impact change from baseline||2.6|-8.8|0.2849
72407929|NCT00330551|144324176|SUPERIORITY||t-test|0.77|||=|0.05|TWO_SIDED|95.0|0.483|1.058|||t-test, 2 sided||||t(80)=5.3, p\<.001|1.058|0.483|=.05
72407930|NCT00330551|144324177|SUPERIORITY||Risk Difference (RD)|11.1|||=|0.001|TWO_SIDED||||||Chi-squared|||||||=.001
72407931|NCT00330551|144324178|SUPERIORITY||||||=|0.83|||||||Chi-squared|||||||=.83
72407932|NCT00330551|144324179|SUPERIORITY||||||=|0.2|||||||ANOVA|||A priori hypothesis was that long-acting injectible risperidone would lead to greater duration of work/school attendance than oral risperidone.||||=.20
72407933|NCT00330551|144324180|SUPERIORITY|||||||0.71|||||||ANOVA|||||||.71
72407934|NCT00330551|144324181|SUPERIORITY||||||=|0.57|||||||ANOVA|||||||=.57
72407935|NCT00330551|144324183|SUPERIORITY||||||<|0.16|||||||ANOVA|||||||<.16
72407936|NCT00330551|144324184|SUPERIORITY||||||=|0.41|||||||ANOVA|||||||=.41
72407937|NCT03120013|144324194|SUPERIORITY||||||<|0.001|||||||ANCOVA|||||||<0.001
72407938|NCT03120013|144324195|SUPERIORITY||||||<|0.001|||||||ANCOVA|||||||<0.001
72407939|NCT03120013|144324196|SUPERIORITY||||||<|0.001|||||||ANCOVA|||||||<0.001
72407940|NCT03120013|144324197|SUPERIORITY||||||<|0.001|||||||ANCOVA|||||||<0.001
72407941|NCT03120013|144324198|SUPERIORITY||||||<|0.001|||||||ANCOVA|||||||<0.001
72407942|NCT03120013|144324199|SUPERIORITY||||||=|0.006|||||||ANCOVA|||||||=0.006
72407943|NCT03120013|144324200|SUPERIORITY||||||<|0.001|||||||ANCOVA|||||||<0.001
72407944|NCT03120013|144324201|SUPERIORITY||||||=|0.043|||||||ANCOVA|||||||=0.043
72407945|NCT01339390|144324246|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3941|STANDARD_ERROR_OF_MEAN|0.5759||0.4937|TWO_SIDED|95.0|-0.7347|1.5229||calculated after fitting the data to a repeated measures mixed model to control for repeated subject and random site and group effects|t-test, 2 sided|accounted for repeated measures and random effects|The difference is expressed as the Move (arm 2) group minus the Move Out (arm 1) group|This is the analysis at 12 months, comparing the change in weight from 12 months to baseline in our Move Out (arm 1) vs Move (arm 2) groups||1.5229|-.7347|0.4937
72407946|NCT01339390|144324246|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.5893|STANDARD_ERROR_OF_MEAN|0.5759||0.3062|TWO_SIDED|95.0|-0.5395|1.7181||calculated after fitting the data to a repeated measures mixed model to control for repeated subject and random site and group effects|t-test, 2 sided|accounted for repeated measures and random effects|The difference is expressed as the Move (arm 2) group minus the Move Out (arm 1) group|This is the analysis at 24 months, comparing the change in weight from 24 months to baseline in our Move Out (arm 1) vs Move (arm 2) groups||1.7181|-0.5395|0.3062
72407947|NCT04847674|144324247|OTHER||LS mean difference|-0.027||||0.7914|TWO_SIDED|95.0|-0.2276|0.174|||Mixed Models Analysis|||Analysis was performed using an MMRM with treatment group, week, randomization factors, and treatment group by week interaction as fixed effects, and baseline FEV1 as a covariate.||0.1740|-0.2276|0.7914
72407948|NCT04847674|144324247|OTHER||LS mean difference|-0.011||||0.9115|TWO_SIDED|95.0|-0.2126|0.19|||Mixed Models Analysis|||Analysis was performed using an MMRM with treatment group, week, randomization factors, and treatment group by week interaction as fixed effects, and baseline FEV1 as a covariate.||0.1900|-0.2126|0.9115
72407949|NCT04847674|144324249|OTHER||LS mean difference|0.026||||0.6001|TWO_SIDED|95.0|-0.0733|0.1261|||Mixed Models Analysis||Change from baseline in FEV1 over 12 weeks: TEV-53275 Dose A versus Placebo|Analysis was performed using an MMRM with treatment group, week, randomization factors, and treatment group by week interaction as fixed effects, and baseline FEV1 as a covariate.||0.1261|-0.0733|0.6001
72407950|NCT04847674|144324249|OTHER||LS mean difference|0.027||||0.5922|TWO_SIDED|95.0|-0.0732|0.1276|||Mixed Models Analysis||Change from baseline in FEV1 over 12 weeks: TEV-53275 Dose B versus Placebo|Analysis was performed using an MMRM with treatment group, week, randomization factors, and treatment group by week interaction as fixed effects, and baseline FEV1 as a covariate.||0.1276|-0.0732|0.5922
72407951|NCT04847674|144324249|OTHER||LS mean difference|0.027||||0.6017|TWO_SIDED|95.0|-0.0744|0.1277|||Mixed Models Analysis||Change from baseline in FEV1 over 16 weeks: TEV-53275 Dose A versus Placebo|Analysis was performed using an MMRM with treatment group, week, randomization factors, and treatment group by week interaction as fixed effects, and baseline FEV1 as a covariate.||0.1277|-0.0744|0.6017
72407952|NCT04847674|144324249|OTHER||LS mean difference|0.022||||0.6664|TWO_SIDED|95.0|-0.0796|0.1239|||Mixed Models Analysis||Change from baseline in FEV1 over 16 weeks: TEV-53275 Dose B versus Placebo|Analysis was performed using an MMRM with treatment group, week, randomization factors, and treatment group by week interaction as fixed effects, and baseline FEV1 as a covariate.||0.1239|-0.0796|0.6664
72407953|NCT04847674|144324250|OTHER||Hodges-Lehmann (HL) estimator|0.4||||0.7261|TWO_SIDED|95.0|-2.33|3.31|||Wilcoxon (Mann-Whitney)||Change from baseline in weekly average of rescue medication use over 12 weeks: TEV-53275 Dose A versus Placebo|Analysis was performed using Wilcoxon rank-sum test stratified on randomization stratification factors.||3.31|-2.33|0.7261
72407954|NCT04847674|144324250|OTHER||HL estimator|-0.5||||0.765|TWO_SIDED|95.0|-3.56|3.32|||Wilcoxon (Mann-Whitney)||Change from baseline in weekly average of rescue medication use over 12 weeks: TEV-53275 Dose B versus Placebo|Analysis was performed using Wilcoxon rank-sum test stratified on randomization stratification factors.||3.32|-3.56|0.7650
72407955|NCT04847674|144324250|OTHER||HL estimator|0.2||||0.7942|TWO_SIDED|95.0|-2.44|3.04|||Wilcoxon (Mann-Whitney)||Change from baseline in weekly average of rescue medication use over 16 weeks: TEV-53275 Dose A versus Placebo|Analysis was performed using Wilcoxon rank-sum test stratified on randomization stratification factors.||3.04|-2.44|0.7942
72407956|NCT04847674|144324250|OTHER||HL estimator|-0.8||||0.6147|TWO_SIDED|95.0|-3.81|2.55|||Wilcoxon (Mann-Whitney)||Change from baseline in weekly average of rescue medication use over 16 weeks: TEV-53275 Dose B versus Placebo|Analysis was performed using Wilcoxon rank-sum test stratified on randomization stratification factors.||2.55|-3.81|0.6147
72571969|NCT02912650|144671808|SUPERIORITY_OR_OTHER||LS Mean Difference|0.6||||0.078|TWO_SIDED|95.0|-0.07|1.28|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.28|-0.07|0.078
72407957|NCT04847674|144324252|OTHER||LS mean difference|-0.083||||0.4394|TWO_SIDED|95.0|-0.2971|0.1301|||Mixed Models Analysis|||Analysis was performed using an MMRM with treatment group, week, randomization factors, and treatment group by week interaction as fixed effects, and baseline FEV1 as a covariate.||0.1301|-0.2971|0.4394
72530341|NCT02516605|144590597|OTHER||Median difference from baseline|-13.82|STANDARD_ERROR_OF_MEAN|6.797||0.047|TWO_SIDED|90.0|-25.21|-2.43|||ANCOVA|day 56||||-2.43|-25.21|0.047
72530342|NCT02516605|144590597|OTHER||Median difference from baseline|-18.23|STANDARD_ERROR_OF_MEAN|8.11||0.029|TWO_SIDED|90.0|-31.81|-4.64|||ANCOVA|Day 84||||-4.64|-31.81|0.029
72571970|NCT02912650|144671808|SUPERIORITY_OR_OTHER||LS Mean Difference|0.09||||0.716|TWO_SIDED|95.0|-0.38|0.56|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.56|-0.38|0.716
72571971|NCT02912650|144671808|SUPERIORITY_OR_OTHER||LS Mean Difference|0.31||||0.197|TWO_SIDED|95.0|-0.16|0.79|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.79|-0.16|0.197
72625646|NCT03021486|144780682|OTHER|||||||0.82|||||||Two-tailed Fisher's exact test|||Perceived Comfort level as assessed by nurse||||0.82
72407958|NCT04847674|144324252|OTHER||LS mean difference|-0.089||||0.4051|TWO_SIDED|95.0|-0.302|0.1231|||Mixed Models Analysis|||Analysis was performed using an MMRM with treatment group, week, randomization factors, and treatment group by week interaction as fixed effects, and baseline FEV1 as a covariate.||0.1231|-0.3020|0.4051
72407959|NCT04847674|144324255|OTHER||LS mean difference|0.093||||0.3485|TWO_SIDED|95.0|-0.1031|0.2893|||Mixed Models Analysis||Change from baseline in FEF25-75 over 12 weeks: TEV-53275 Dose A versus Placebo|Analysis was performed using an MMRM with treatment group, week, randomization factors, and treatment group by week interaction as fixed effects, and baseline FEF25-75 as a covariate.||0.2893|-0.1031|0.3485
72571972|NCT02912650|144671808|SUPERIORITY_OR_OTHER||LS Mean Difference|0.52||||0.131|TWO_SIDED|95.0|-0.15|1.19|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.19|-0.15|0.131
72571973|NCT02912650|144671808|SUPERIORITY_OR_OTHER||LS Mean Difference|0.29||||0.399|TWO_SIDED|95.0|-0.39|0.97|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.97|-0.39|0.399
72407960|NCT04847674|144324255|OTHER||LS mean difference|0.033||||0.7432|TWO_SIDED|95.0|-0.1644|0.2296|||Mixed Models Analysis||Change from baseline in FEF25-75 over 12 weeks: TEV-53275 Dose B versus Placebo|Analysis was performed using an MMRM with treatment group, week, randomization factors, and treatment group by week interaction as fixed effects, and baseline FEF25-75 as a covariate.||0.2296|-0.1644|0.7432
72571974|NCT02912650|144671808|SUPERIORITY_OR_OTHER||LS Mean Difference|0.23||||0.349|TWO_SIDED|95.0|-0.25|0.7|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.70|-0.25|0.349
72571975|NCT02912650|144671808|SUPERIORITY_OR_OTHER||LS Mean Difference|0.46||||0.169|TWO_SIDED|95.0|-0.2|1.12|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.12|-0.20|0.169
72625647|NCT03021486|144780682|OTHER|||||||0.91|||||||Two-tailed Fisher's exact test|||Perceived agitation level as assessed by nurse||||0.91
72625648|NCT03021486|144780683|OTHER|||||||0.12|||||||Wilcoxon Rank Sum Test|||Nursing assessment, disorientation to time - frequency||||0.12
72530343|NCT02516605|144590597|OTHER||Median difference from baseline|26.7|STANDARD_ERROR_OF_MEAN|8.799||0.004|TWO_SIDED|90.0|11.97|41.44|||ANCOVA|Day 7||||41.44|11.97|0.004
72530344|NCT02516605|144590597|OTHER||Median difference from baseline|8.17|STANDARD_ERROR_OF_MEAN|9.032||0.37|TWO_SIDED|90.0|-6.96|23.29|||ANCOVA|Day 14||||23.29|-6.96|0.370
72530345|NCT02516605|144590597|OTHER||Median difference from baseline|5.9|STANDARD_ERROR_OF_MEAN|10.014||0.558|TWO_SIDED|90.0|-10.86|22.66|||ANCOVA|Day 21||||22.66|-10.86|0.558
72530346|NCT02516605|144590597|OTHER||Median difference from baseline|8.91|STANDARD_ERROR_OF_MEAN|10.911||0.418|TWO_SIDED|90.0|-9.34|27.15|||ANCOVA|Day 28||||27.15|-9.34|0.418
72530347|NCT02516605|144590597|OTHER||Median difference from baseline|-11.08|STANDARD_ERROR_OF_MEAN|7.69||0.156|TWO_SIDED|90.0|-23.95|1.8|||ANCOVA|Day 56||||1.80|-23.95|0.156
72530348|NCT02516605|144590597|OTHER||Median difference from baseline|-16.93|STANDARD_ERROR_OF_MEAN|8.961||0.064|TWO_SIDED|90.0|-31.94|-1.92|||ANCOVA|Day 84||||-1.92|-31.94|0.064
72571976|NCT02912650|144671808|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.02||||0.937|TWO_SIDED|95.0|-0.48|0.44|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.44|-0.48|0.937
72571977|NCT02912650|144671808|SUPERIORITY_OR_OTHER||LS Mean Difference|0.22||||0.351|TWO_SIDED|95.0|-0.25|0.69|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.69|-0.25|0.351
72571978|NCT02912650|144671808|SUPERIORITY_OR_OTHER||LS Mean Difference|0.48||||0.151|TWO_SIDED|95.0|-0.18|1.14|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.14|-0.18|0.151
72571979|NCT02912650|144671808|SUPERIORITY_OR_OTHER||LS Mean Difference|0.24||||0.476|TWO_SIDED|95.0|-0.42|0.9|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.90|-0.42|0.476
72571980|NCT02912650|144671808|SUPERIORITY_OR_OTHER||LS Mean Difference|0.24||||0.31|TWO_SIDED|95.0|-0.22|0.71|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.71|-0.22|0.310
72625649|NCT03021486|144780683|OTHER|||||||0.07|||||||Wilcoxon Rank Sum Test|||Nursing assessment, disorientation to place - frequency||||0.07
72625650|NCT03021486|144780683|OTHER|||||||0.051|||||||Wilcoxon Rank Sum Test|||Nursing assessment, visual hallucination - frequency||||0.051
72625651|NCT03021486|144780683|OTHER|||||||0.048|||||||Wilcoxon Rank Sum Test|||Nursing assessment, tactile hallucination - frequency||||0.048
72625652|NCT03021486|144780683|OTHER|||||||0.15|||||||Wilcoxon Rank Sum Test|||Nursing assessment, auditory hallucination - frequency||||0.15
72625653|NCT03021486|144780683|OTHER|||||||0.1|||||||Wilcoxon Rank Sum Test|||Nursing assessment, delusional thoughts - frequency||||0.10
72407961|NCT04847674|144324255|OTHER||LS mean difference|0.087||||0.4014|TWO_SIDED|95.0|-0.118|0.292|||Mixed Models Analysis||Change from baseline in FEF25-75 over 16 weeks: TEV-53275 Dose A versus Placebo|Analysis was performed using an MMRM with treatment group, week, randomization factors, and treatment group by week interaction as fixed effects, and baseline FEF25-75 as a covariate.||0.2920|-0.1180|0.4014
72530349|NCT02839330|144590598|EQUIVALENCE|Equivalence margin: The 2-sided 95% confidence interval (CI) of all the 3 pairwise comparisons of GMTs to fall between the predefined equivalence ranges of 0.667 and 1.5|GMT ratio|1.01|||||TWO_SIDED|95.0|0.9|1.13||||||aH5N1c Lot #1 vs. aH5N1c Lot #2||1.13|0.90|
72530350|NCT02839330|144590598|EQUIVALENCE|Equivalence margin: The 2-sided 95% CIs of all the 3 pairwise comparisons of GMTs to fall between the predefined equivalence ranges of 0.667 and 1.5|GMT ratio|0.96|||||TWO_SIDED|95.0|0.86|1.08||||||aH5N1c Lot #2 vs. aH5N1c Lot #3||1.08|0.86|
72530351|NCT02839330|144590598|EQUIVALENCE|Equivalence margin: The 2-sided 95% CIs of all the 3 pairwise comparisons of GMTs to fall between the predefined equivalence ranges of 0.667 and 1.5|GMT ratio|0.97|||||TWO_SIDED|95.0|0.87|1.09||||||aH5N1c Lot #1 vs. aH5N1c Lot #3||1.09|0.87|
72530352|NCT02467504|144590610|OTHER|||||||0.53|||||||Chi-squared|||||||0.530
72530353|NCT02467504|144590611|OTHER|||||||0.315|||||||Chi-squared|||||||0.315
72530354|NCT02467504|144590612|OTHER|||||||0.018|||||||Mixed Models Analysis|||||||0.018
72625654|NCT03021486|144780683|OTHER|||||||0.15|||||||Wilcoxon Rank Sum Test|||Nursing assessment, psychomotor agitation- frequency||||0.15
72407962|NCT04847674|144324255|OTHER||LS mean difference|0.01||||0.9259|TWO_SIDED|95.0|-0.196|0.2153|||Mixed Models Analysis||Change from baseline in FEF25-75 over 16 weeks: TEV-53275 Dose B versus Placebo|Analysis was performed using an MMRM with treatment group, week, randomization factors, and treatment group by week interaction as fixed effects, and baseline FEF25-75 as a covariate.||0.2153|-0.1960|0.9259
72530355|NCT02467504|144590613|OTHER|||||||0.015|||||||Mixed Models Analysis|||||||0.015
72530356|NCT02467504|144590614|OTHER|Chi||||||0.474|||||||Chi-squared|||||||0.474
72530357|NCT02467504|144590615|OTHER|description of Treg cells in CD4+ T cells||||||0.665|||||||Mixed Models Analysis|||||||0.665
72530358|NCT02467504|144590616|OTHER|||||||0.616|||||||Chi-squared|||||||0.616
72530359|NCT02467504|144590617|OTHER|||||||0.616|||||||Chi-squared|||||||0.616
72530360|NCT02467504|144590618|OTHER|||||||0.2|||||||Chi-squared|||||||0.200
72530361|NCT02467504|144590619|OTHER|||||||0.373|||||||Chi-squared|||||||0.373
72530362|NCT02467504|144590620|OTHER|||||||0.565|||||||Chi-squared|||||||0.565
72530363|NCT02467504|144590621|OTHER|||||||0.221|||||||Wilcoxon (Mann-Whitney)|||||||0.221
72530364|NCT02467504|144590622|OTHER|||||||0.085|||||||Wilcoxon (Mann-Whitney)|||||||0.085
72530365|NCT02467504|144590623|OTHER|||||||0.74|||||||Wilcoxon (Mann-Whitney)|||||||0.740
72530366|NCT02467504|144590624|OTHER|||||||0.881|||||||Mixed Models Analysis|||||||0.881
72530367|NCT02467504|144590625|OTHER|||||||0.422|||||||Mixed Models Analysis|||||||0.422
72530368|NCT02467504|144590626|OTHER|||||||0.055|||||||Wilcoxon (Mann-Whitney)|||||||0.055
72530369|NCT02467504|144590627|OTHER|||||||0.039|||||||Wilcoxon (Mann-Whitney)|||||||0.039
72530370|NCT02467504|144590628|OTHER|||||||0.156|||||||Wilcoxon (Mann-Whitney)|||||||0.156
72530371|NCT04047472|144590633|NON_INFERIORITY|Non-inferiority of brolucizumab to aflibercept with respect to change from baseline in BCVA, considering a margin of 4 letters.|LS mean difference|-1.1|STANDARD_ERROR_OF_MEAN|1.16||0.006|TWO_SIDED|90.0|-3.0|0.9|||ANOVA|||||0.9|-3.0|0.006
72530372|NCT04047472|144590634|NON_INFERIORITY|Non-inferiority of brolucizumab to aflibercept with respect to change from baseline in BCVA, considering a margin of 4 letters.|LS mean difference|-1.4|STANDARD_ERROR_OF_MEAN|1.11||0.009|TWO_SIDED|90.0|-3.2|0.5|||ANOVA|||||0.5|-3.2|0.009
72530373|NCT04269629|144590693|OTHER|All patients participating in this study belong to one of the following two groups for analysis: the group with antihypertensive treatment (β-blockers or ACEI) and the group without such treatment. The primary outcome was analyzed using logistic linear mixed models with a random intercept. This model type takes into account the clustered structure of the data, i.e., observations clustered in the different participating centers.||||||0.25||||||The level of significance was set at 0.05.|Mixed Models Analysis|Missing at random was assumed, and multiple imputations were conducted with 50 imputations taking into account the cluster design.||It was assumed that 24% of the patients would be on β-blockers and/or ACE inhibitors (ACEI). A χ2 test with a two-sided 5% significance level has an 80% power to detect the difference between the group without antihypertensive medication with 6% SR during VIT and the group on β-blockers and/or ACEI with 12.3% SR during VIT (OR = 2.2) when the sample sizes are 631 and 200, respectively. A drop-out rate of 37% was assumed which resulted in a required number of 1,319 patients.||||0.25
72530374|NCT04269629|144590694|OTHER|All patients participating in this study belong to one of the following two groups for analysis: the group with antihypertensive treatment (β-blockers or ACE inhibitors) and the group without such treatment. The secondary outcomes was analyzed using logistic linear mixed models with a random intercept. This model type takes into account the clustered structure of the data, i.e., observations clustered in the different participating centers.||||||0.29||||||The level of significance was set at 0.05.|Mixed Models Analysis|Missing at random was assumed, and multiple imputations were conducted with 50 imputations taking into account the cluster design.||||||0.29
72530375|NCT04269629|144590695|OTHER|All patients participating in this study belong to one of the following two groups for analysis: the group with antihypertensive treatment (β-blockers or ACE inhibitor) and the group without such treatment. The secondary outcomes were analyzed using logistic linear mixed models with a random intercept. This model type takes into account the clustered structure of the data, i.e., observations clustered in the different participating centers.||||||0.04||||||The level of significance was set at 0.05. Correlation of the prevalence of cardiovascular diseases and/or hypertension with the risk for more severe systemic sting reactions (p=0.04).|Mixed Models Analysis|Missing at random was assumed, and multiple imputations were conducted with 50 imputations taking into account the cluster design.||Analysis for correlation of the prevalence of cardiovascular diseases and/or hypertension with the risk for more severe systemic sting reactions.||||0.04
72571981|NCT02912650|144671809|SUPERIORITY_OR_OTHER||LS Mean Difference|7.35|||<|0.001|TWO_SIDED|95.0|6.09|8.61|||ANCOVA|||0 to 2 hours: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||8.61|6.09|<0.001
72530376|NCT04269629|144590696|OTHER|All patients participating in this study belong to one of the following two groups for analysis: the group with antihypertensive treatment (β-blockers or ACE inhibitors) and the group without such treatment. The secondary outcomes was analyzed using logistic linear mixed models with a random intercept. This model type takes into account the clustered structure of the data, i.e., observations clustered in the different participating centers.|||||<|0.001||||||The level of significance was set at 0.05.|Mixed Models Analysis|Missing at random was assumed, and multiple imputations were conducted with 50 imputations taking into account the cluster design.||||||<0.001
72530377|NCT04269629|144590697|OTHER|All patients participating in this study belong to one of the following two groups for analysis: the group with antihypertensive treatment (β-blockers or ACE inhibitors) and the group without such treatment. The secondary outcomes was analyzed using logistic linear mixed models with a random intercept. This model type takes into account the clustered structure of the data, i.e., observations clustered in the different participating centers.||||||0.99||||||The level of significance was set at 0.05.|Mixed Models Analysis|Missing at random was assumed, and multiple imputations were conducted with 50 imputations taking into account the cluster design.||Analysis for sIgE levels - bee venom.||||0.99
72530378|NCT04269629|144590697|OTHER|All patients participating in this study belong to one of the following two groups for analysis: the group with antihypertensive treatment (β-blockers or ACE inhibitors) and the group without such treatment. The secondary outcomes was analyzed using logistic linear mixed models with a random intercept. This model type takes into account the clustered structure of the data, i.e., observations clustered in the different participating centers.||||||0.15||||||The level of significance was set at 0.05.|Mixed Models Analysis|Missing at random was assumed, and multiple imputations were conducted with 50 imputations taking into account the cluster design.||Analysis for sIgE levels - vespid venom.||||0.15
72530379|NCT04269629|144590698|OTHER|All patients participating in this study belong to one of the following two groups for analysis: the group with antihypertensive treatment (β-blockers or ACE inhibitors) and the group without such treatment. The secondary outcomes was analyzed using logistic linear mixed models with a random intercept. This model type takes into account the clustered structure of the data, i.e., observations clustered in the different participating centers.||||||0.16||||||The level of significance was set at 0.05.|Mixed Models Analysis|Missing at random was assumed, and multiple imputations were conducted with 50 imputations taking into account the cluster design.||||||0.16
72530380|NCT04269629|144590699|OTHER|All patients participating in this study belong to one of the following two groups for analysis: the group with antihypertensive treatment (β-blockers or ACE inhibitors) and the group without such treatment. The secondary outcomes was analyzed using logistic linear mixed models with a random intercept. This model type takes into account the clustered structure of the data, i.e., observations clustered in the different participating centers.||||||0.5||||||The level of significance was set at 0.05.|Mixed Models Analysis|Missing at random was assumed, and multiple imputations were conducted with 50 imputations taking into account the cluster design.||||||0.50
72571982|NCT02912650|144671809|SUPERIORITY_OR_OTHER||LS Mean Difference|1.41||||0.002|TWO_SIDED|95.0|0.53|2.28|||ANCOVA|||0 to 2 hours: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||2.28|0.53|0.002
72571983|NCT02912650|144671809|SUPERIORITY_OR_OTHER||LS Mean Difference|1.98|||<|0.001|TWO_SIDED|95.0|1.09|2.88|||ANCOVA|||0 to 2 hours: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||2.88|1.09|<0.001
72625655|NCT03021486|144780683|OTHER|||||||0.98|||||||Wilcoxon Rank Sum Test|||Nursing assessment, disorientation to time - distress||||0.98
72571984|NCT02912650|144671809|SUPERIORITY_OR_OTHER||LS Mean Difference|5.94|||<|0.001|TWO_SIDED|95.0|4.69|7.2|||ANCOVA|||0 to 2 hours: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||7.20|4.69|<0.001
72625656|NCT03021486|144780683|OTHER|||||||0.93|||||||Wilcoxon Rank Sum Test|||Nursing assessment, disorientation to place - distress||||0.93
72625657|NCT03021486|144780683|OTHER|||||||0.08|||||||Wilcoxon Rank Sum Test|||Nursing assessment, visual hallucination - distress||||0.08
72625658|NCT03021486|144780683|OTHER|||||||0.28|||||||Wilcoxon Rank Sum Test|||Nursing assessment, tactile hallucination - distress||||0.28
72530381|NCT04269629|144590700|OTHER|||||||0.72||||||The level of significance was set at 0.05.|Fisher Exact|||||||0.72
72530382|NCT04269629|144590701|OTHER|All patients participating in this study belong to one of the following two groups for analysis: the group with antihypertensive treatment (β-blockers or ACE inhibitor) and the group without such treatment. The secondary outcomes were analyzed using logistic linear mixed models with a random intercept. This model type takes into account the clustered structure of the data, i.e., observations clustered in the different participating centers.||||||0.11||||||The level of significance was set at 0.05.|Mixed Models Analysis|Missing at random was assumed, and multiple imputations were conducted with 50 imputations taking into account the cluster design.||Analysis for correlation of the prevalence of cardiovascular diseases and/or hypertension with the risk for more frequent SR under VIT.||||0.11
72530383|NCT01535638|144590702|SUPERIORITY_OR_OTHER||Ratio (%)|123.4|STANDARD_DEVIATION|17.1|||TWO_SIDED|90.0|108.0|141.1|||||The estimate of the relative bioavailability (%) is adjusted for the period effects in the ANOVA. The standard deviation is actually the gCV. CIs are based on the residual error from ANOVA, considering only the data from the 2 compared treatments.|Relative bioavailability comparison of Deleobuvir Trial Formulation II (reference) and Deleobuvir Final Formulation (test) in pairwise comparison. (reference : test)||141.1|108.0|
72530384|NCT01535638|144590702|SUPERIORITY_OR_OTHER||Ratio (%)|109.8|STANDARD_DEVIATION|28.8|||TWO_SIDED|90.0|88.6|136.1|||||The estimate of the relative bioavailability (%) is adjusted for the period effects in the ANOVA. The standard deviation is actually the gCV. CIs are based on the residual error from ANOVA, considering only the data from the 2 compared treatments.|relative bioavailability comparison of Deleobuvir Final Formulation modified (test) and Deleobuvir Final Formulation (reference) in pairwise comparison. (reference : test)||136.1|88.6|
72625659|NCT03021486|144780683|OTHER|||||||0.83|||||||Wilcoxon Rank Sum Test|||Nursing assessment, auditory hallucination - distress||||0.83
72625660|NCT03021486|144780683|OTHER|||||||0.22|||||||Wilcoxon Rank Sum Test|||Nursing assessment, delusional thoughts - distress||||0.22
72407963|NCT04847674|144324257|OTHER||LS mean difference|0.0||||0.9829|TWO_SIDED|95.0|-0.43|0.42|||Mixed Models Analysis||Change from baseline in ACQ-6 at Week 12: TEV-53275 Dose A versus Placebo|Analysis was performed using an MMRM with treatment group, week, randomization factors, and treatment group by week interaction as fixed effects, and baseline ACQ-6 as a covariate.||0.42|-0.43|0.9829
72407964|NCT04847674|144324257|OTHER||LS mean difference|0.1||||0.6302|TWO_SIDED|95.0|-0.32|0.52|||Mixed Models Analysis||Change from baseline in ACQ-6 at Week 12: TEV-53275 Dose B versus Placebo|Analysis was performed using an MMRM with treatment group, week, randomization factors, and treatment group by week interaction as fixed effects, and baseline ACQ-6 as a covariate.||0.52|-0.32|0.6302
72530385|NCT01535638|144590703|SUPERIORITY_OR_OTHER||Ratio (%)|122.5|STANDARD_DEVIATION|16.1|||TWO_SIDED|90.0|107.9|139.1|||||The estimate of the relative bioavailability (%) is adjusted for the period effects in the ANOVA. The standard deviation is actually the gCV. CIs are based on the residual error from ANOVA, considering only the data from the 2 compared treatments.|relative bioavailability comparison of Deleobuvir Final Formulation (test) and Deleobuvir Trial Formulation II (reference) in pairwise comparison. (test : reference)||139.1|107.9|
72530386|NCT01535638|144590703|SUPERIORITY_OR_OTHER||Ratio (%)|107.6|STANDARD_DEVIATION|35.0|||TWO_SIDED|90.0|83.1|139.4|||||The estimate of the relative bioavailability (%) is adjusted for the period effects in the ANOVA. The standard deviation is actually the gCV. CIs are based on the residual error from ANOVA, considering only the data from the 2 compared treatments.|relative bioavailability comparison of Deleobuvir Final Formulation modified (test) and Deleobuvir Final Formulation (reference) in pairwise comparison. (test : reference)||139.4|83.1|
72530387|NCT03702166|144590710|SUPERIORITY|||||||0.01|||||||t-test, 1 sided|Multiple t-tests with Bonferroni corrections for multiple comparisons||||||0.01
72530388|NCT03702166|144590712|SUPERIORITY|||||||0.038|||||||t-test, 1 sided|Multiple t-tests, with Bonferroni corrections for multiple comparisons,||||||0.038
72530389|NCT03702166|144590714|SUPERIORITY|||||||0.031||||||Multiple t-tests, with Bonferroni corrections for multiple comparisons|t-test, 1 sided|||||||0.031
72530390|NCT01657903|144590716|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|41.15|||<|0.0001|TWO_SIDED|95.0|34.42|47.89||No adjustments made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment, study period, and subject (random effect).|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered population means for the treatments in comparison to be equal with respect to %RER. Statistical tests were 2-sided with a significance level of 0.05.||47.89|34.42|<0.0001
72625661|NCT03021486|144780683|OTHER|||||||0.75|||||||Wilcoxon Rank Sum Test|||Nursing assessment, psychomotor agitation - distress||||0.75
72407965|NCT04847674|144324257|OTHER||LS mean difference|-0.1||||0.6707|TWO_SIDED|95.0|-0.54|0.35|||Mixed Models Analysis||Change from baseline in ACQ-6 at Week 16: TEV-53275 Dose A versus Placebo|Analysis was performed using an MMRM with treatment group, week, randomization factors, and treatment group by week interaction as fixed effects, and baseline ACQ-6 as a covariate.||0.35|-0.54|0.6707
72407966|NCT04847674|144324257|OTHER||LS mean difference|0.0||||0.994|TWO_SIDED|95.0|-0.44|0.43|||Mixed Models Analysis||Change from baseline in ACQ-6 at Week 16: TEV-53275 Dose B versus Placebo|Analysis was performed using an MMRM with treatment group, week, randomization factors, and treatment group by week interaction as fixed effects, and baseline ACQ-6 as a covariate.||0.43|-0.44|0.9940
72530391|NCT01657903|144590716|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|41.28|||<|0.0001|TWO_SIDED|95.0|34.51|48.06||No adjustments made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment, study period, and subject (random effect).|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered population means for the treatments in comparison to be equal with respect to %RER. Statistical tests were 2-sided with a significance level of 0.05.||48.06|34.51|<0.0001
72530392|NCT01657903|144590716|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|40.83|||<|0.0001|TWO_SIDED|95.0|34.06|47.61||No adjustments made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment, study period, and subject (random effect).|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered population means for the treatments in comparison to be equal with respect to %RER. Statistical tests were 2-sided with a significance level of 0.05.||47.61|34.06|<0.0001
72530393|NCT01657903|144590717|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|9.36|||<|0.0001|TWO_SIDED|95.0|6.01|12.72||No adjustments made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment, study period, and subject (random effect).|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered population means for the treatments in comparison to be equal with respect to %SMH recovery. Statistical tests were 2-sided with a significance level of 0.05.||12.72|6.01|<0.0001
72530394|NCT01657903|144590717|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|9.45|||<|0.0001|TWO_SIDED|95.0|6.07|12.82||No adjustments made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment, study period, and subject (random effect).|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered population means for the treatments in comparison to be equal with respect to %SMH recovery. Statistical tests were 2-sided with a significance level of 0.05.||12.82|6.07|<0.0001
72530395|NCT01657903|144590717|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|11.66|||<|0.0001|TWO_SIDED|95.0|8.28|15.03||No adjustments made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment, study period, and subject (random effect).|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered population means for the treatments in comparison to be equal with respect to %SMH recovery. Statistical tests were 2-sided with a significance level of 0.05.||15.03|8.28|<0.0001
72530396|NCT02155725|144590800|SUPERIORITY||Odds Ratio (OR)|0.9889||||0.9563|TWO_SIDED|95.0|0.6633|1.4744|||Regression, Logistic|||||1.4744|0.6633|0.9563
72530397|NCT02155725|144590801|SUPERIORITY||Odds Ratio (OR)|1.0064||||0.9786|TWO_SIDED|95.0|0.6321|1.6022|||Regression, Logistic|||Failure on individual component of the primary endpoint defined as administration of 2 units of RBCs.||1.6022|0.6321|0.9786
72530398|NCT02155725|144590802|SUPERIORITY||Odds Ratio (OR)|1.0169||||0.9474|TWO_SIDED|95.0|0.6177|1.6741|||Regression, Logistic|||Failure on individual component of the primary endpoint defined as a loss of at least 4 g/dL of Hb.||1.6741|0.6177|0.9474
72530399|NCT00842829|144590803|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the upper limit of the 90% CI was \<8%.|Mean Difference (Net)|-6.3|||||ONE_SIDED|95.0||1.4|||||The upper bound of the 2-sided 90% confidence interval is equivalent to the upper bound of the 1-sided 95% confidence interval.|Treatment comparison difference (100 mcg - 200 mcg)||1.4||
72530400|NCT03091920|144590841|OTHER|No statistical testing was performed.|LS Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|6.4|||TWO_SIDED|95.0|-14.2|12.4|||||LS mean difference and associated 95% confidence interval (CI) is from an analysis of covariance (ANCOVA) model with treatment as fixed effect and baseline as covariate. Standard Error of the Mean=Standard Error of the LS Mean Difference.|Day 1 postdose AM 1 hour||12.4|-14.2|
72530401|NCT03091920|144590841|OTHER|No statistical testing was performed.|Least squares mean difference|0.6|STANDARD_ERROR_OF_MEAN|6.0|||TWO_SIDED|95.0|-11.8|12.9|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1 postdose AM 1 hour||12.9|-11.8|
72530402|NCT03091920|144590841|OTHER|No statistical testing was performed.|Least squares mean difference|-13.9|STANDARD_ERROR_OF_MEAN|8.1|||TWO_SIDED|95.0|-30.6|2.8|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1 postdose AM 4 hour||2.8|-30.6|
72530403|NCT03091920|144590841|OTHER|No statistical testing was performed.|Least squares mean difference|-15.5|STANDARD_ERROR_OF_MEAN|7.5|||TWO_SIDED|95.0|-31.0|0.0|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1 postdose AM 4 hour||0|-31.0|
72530404|NCT03091920|144590841|OTHER|No statistical testing was performed.|Least squares mean difference|-9.9|STANDARD_ERROR_OF_MEAN|6.7|||TWO_SIDED|95.0|-23.8|3.9|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1 postdose AM 8 hour||3.9|-23.8|
72530405|NCT03091920|144590841|OTHER|No statistical testing was performed.|Least squares mean difference|-3.1|STANDARD_ERROR_OF_MEAN|6.2|||TWO_SIDED|95.0|-16.0|9.7|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1 postdose AM 8 hour||9.7|-16.0|
72530406|NCT03091920|144590841|OTHER|No statistical testing was performed.|Least squares mean difference|-8.8|STANDARD_ERROR_OF_MEAN|8.4|||TWO_SIDED|95.0|-26.2|8.6|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1 predose PM||8.6|-26.2|
72530407|NCT03091920|144590841|OTHER|No statistical testing was performed.|Least squares mean difference|-3.6|STANDARD_ERROR_OF_MEAN|7.8|||TWO_SIDED|95.0|-19.7|12.6|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1 predose PM||12.6|-19.7|
72530408|NCT03091920|144590841|OTHER|No statistical testing was performed.|Least squares mean difference|-3.3|STANDARD_ERROR_OF_MEAN|7.5|||TWO_SIDED|95.0|-18.7|12.2||||||Day 1 postdose PM 1 hour||12.2|-18.7|
72530409|NCT03091920|144590841|OTHER|No statistical testing was performed.|Least squares mean difference|-4.4|STANDARD_ERROR_OF_MEAN|6.9|||TWO_SIDED|95.0|-18.7|9.9|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1 postdose PM||9.9|-18.7|
72530410|NCT03091920|144590841|OTHER|No statistical testing was performed.|Least squares mean difference|-8.5|STANDARD_ERROR_OF_MEAN|4.7|||TWO_SIDED|95.0|-18.2|1.3|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 2 predose AM||1.3|-18.2|
72530411|NCT03091920|144590841|OTHER|No statistical testing was performed.|Least squares mean difference|-5.7|STANDARD_ERROR_OF_MEAN|4.4|||TWO_SIDED|95.0|-14.8|3.3|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 2 predose AM||3.3|-14.8|
72530412|NCT03091920|144590841|OTHER|No statistical testing was performed.|Least squares mean difference|-15.4|STANDARD_ERROR_OF_MEAN|6.1|||TWO_SIDED|95.0|-28.1|-2.8|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 2 postdose AM 1 hour||-2.8|-28.1|
72530413|NCT03091920|144590841|OTHER|No statistical testing was performed.|Least squares mean difference|-9.4|STANDARD_ERROR_OF_MEAN|5.7|||TWO_SIDED|95.0|-21.1|2.3|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 2 postdose AM 1 hour||2.3|-21.1|
72530414|NCT03091920|144590841|OTHER|No statistical testing was performed.|Least squares mean difference|-8.8|STANDARD_ERROR_OF_MEAN|8.1|||TWO_SIDED|95.0|-25.6|7.9|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 2 postdose AM 4 hour||7.9|-25.6|
72530415|NCT03091920|144590841|OTHER|No statistical testing was performed.|Least squares mean difference|-11.2|STANDARD_ERROR_OF_MEAN|7.5|||TWO_SIDED|95.0|-26.7|4.4|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 2 postdose AM 4 hour||4.4|-26.7|
72530416|NCT03091920|144590841|OTHER|No statistical testing was performed.|Least squares mean difference|-11.7|STANDARD_ERROR_OF_MEAN|5.9|||TWO_SIDED|95.0|-24.0|0.6|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 2 predose PM||0.6|-24.0|
72530417|NCT03091920|144590841|OTHER|No statistical testing was performed.|Least squares mean difference|-7.0|STANDARD_ERROR_OF_MEAN|5.5|||TWO_SIDED|95.0|-18.4|4.4|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 2 predose PM||4.4|-18.4|
72530418|NCT03091920|144590841|OTHER|No statistical testing was performed.|Least squares mean difference|1.6|STANDARD_ERROR_OF_MEAN|7.1|||TWO_SIDED|95.0|-13.0|16.2|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 2 postdose PM 1 hour||16.2|-13.0|
72530419|NCT03091920|144590841|OTHER|No statistical testing was performed.|Least squares mean difference|0.7|STANDARD_ERROR_OF_MEAN|6.5|||TWO_SIDED|95.0|-12.9|14.2|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 2 postdose PM 1 hour||14.2|-12.9|
72625662|NCT03021486|144780684|OTHER|||||||0.09|||||||Wilcoxon Rank Sum Test|||||||0.09
72625663|NCT03021486|144780685|OTHER|||||||0.02|||||||Wilcoxon Rank Sum Test|||Mean change in pain.||||0.02
72625664|NCT03021486|144780685|OTHER|||||||0.1|||||||Wilcoxon Rank Sum Test|||Mean change in Fatigue.||||0.10
72625665|NCT03021486|144780685|OTHER|||||||0.02|||||||Wilcoxon Rank Sum Test|||Mean change in Nausea.||||0.02
72625666|NCT03021486|144780685|OTHER|||||||0.97|||||||Wilcoxon Rank Sum Test|||Mean change in Depression.||||0.97
72625667|NCT03021486|144780685|OTHER|||||||0.03|||||||Wilcoxon Rank Sum Test|||Mean change in Anxiety.||||0.03
72530420|NCT03091920|144590841|OTHER|No statistical testing was performed.|Least squares mean difference|-4.7|STANDARD_ERROR_OF_MEAN|5.7|||TWO_SIDED|95.0|-16.4|7.1|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 2 postdose PM 4 hour||7.1|-16.4|
72530421|NCT03091920|144590841|OTHER|No statistical testing was performed.|Least squares mean difference|-3.0|STANDARD_ERROR_OF_MEAN|5.2|||TWO_SIDED|95.0|-13.9|7.9|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 2 postdose PM 4 hour||7.9|-13.9|
72530422|NCT03091920|144590841|OTHER|No statistical testing was performed.|Least squares mean difference|-4.7|STANDARD_ERROR_OF_MEAN|5.3|||TWO_SIDED|95.0|-15.8|6.4|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 3 predose AM||6.4|-15.8|
72530423|NCT03091920|144590841|OTHER|No statistical testing was performed.|Least squares mean difference|-5.8|STANDARD_ERROR_OF_MEAN|5.0|||TWO_SIDED|95.0|-16.0|4.5|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 3 predose AM||4.5|-16.0|
72625668|NCT03021486|144780685|OTHER|||||||0.68|||||||Wilcoxon Rank Sum Test|||Mean change in Drowsiness.||||0.68
72625669|NCT03021486|144780685|OTHER|||||||0.8|||||||Wilcoxon Rank Sum Test|||Mean change in Appetite.||||0.80
72625670|NCT03021486|144780685|OTHER|||||||0.45|||||||Wilcoxon Rank Sum Test|||Mean change in Feeling of well being.||||0.45
72625671|NCT03021486|144780685|OTHER|||||||0.16|||||||Wilcoxon Rank Sum Test|||Mean change in Shortness of breath.||||0.16
72625672|NCT03021486|144780685|OTHER|||||||0.12|||||||Wilcoxon Rank Sum Test|||Mean change in Sleep.||||0.12
72625673|NCT04887831|144780688|OTHER||Adjusted percentage difference|-0.101|STANDARD_ERROR_OF_MEAN|0.1052||0.34|TWO_SIDED|95.0|-0.308|0.105||The 2-sided p-value was calculated using stratified CMH method to account for the presence of visceral metastasis (yes/no) and initial chemotherapy type (cisplatin/carboplatin) as the stratification factors.|Cochran-Mantel-Haenszel|||||0.105|-0.308|0.340
72625674|NCT04887831|144780689|OTHER||Adjusted percentage difference|-0.008|STANDARD_ERROR_OF_MEAN|0.1078||0.938|TWO_SIDED|95.0|-0.22|0.203||The 2-sided p-value was calculated using stratified CMH method to account for the presence of visceral metastasis (yes/no) and initial chemotherapy type (cisplatin/carboplatin) as the stratification factors.|Cochran-Mantel-Haenszel|||||0.203|-0.220|0.938
72625675|NCT05093621|144780745|SUPERIORITY|||||||1|||||||t-test, 2 sided|||Mortality at 1 year||||1.000
72625676|NCT05093621|144780746|SUPERIORITY|||||||0.729|||||||t-test, 2 sided|||||||0.729
72625677|NCT05093621|144780747|SUPERIORITY|||||||0.65|||||||t-test, 2 sided|||||||0.650
72625678|NCT05093621|144780748|SUPERIORITY|||||||0.873|||||||t-test, 2 sided|||||||0.873
72530424|NCT03091920|144590841|OTHER|No statistical testing was performed.|Least squares mean difference|-0.2|STANDARD_ERROR_OF_MEAN|6.4|||TWO_SIDED|95.0|-13.6|13.1|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 3 postdose PM 4 hour||13.1|-13.6|
72530425|NCT03091920|144590841|OTHER|No statistical testing was performed.|Least squares mean difference|-2.8|STANDARD_ERROR_OF_MEAN|6.0|||TWO_SIDED|95.0|-15.2|9.6|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 3 postdose PM 4 hour||9.6|-15.2|
72530426|NCT03091920|144590841|OTHER|No statistical testing was performed.|Least squares mean difference|-6.2|STANDARD_ERROR_OF_MEAN|4.4|||TWO_SIDED|95.0|-15.5|3.0|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 4 predose AM||3.0|-15.5|
72530427|NCT03091920|144590841|OTHER|No statistical testing was performed.|Least squares mean difference|-8.1|STANDARD_ERROR_OF_MEAN|4.1|||TWO_SIDED|95.0|-16.6|0.5|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 4 predose AM||0.5|-16.6|
72530428|NCT03091920|144590841|OTHER|No statistical testing was performed.|Least squares mean difference|-1.7|STANDARD_ERROR_OF_MEAN|4.9|||TWO_SIDED|95.0|-11.8|8.4|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 5 predose AM||8.4|-11.8|
72530429|NCT03091920|144590841|OTHER|No statistical testing was performed.|Least squares mean difference|-10.0|STANDARD_ERROR_OF_MEAN|4.5|||TWO_SIDED|95.0|-19.4|-0.7|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 5 predose AM||-0.7|-19.4|
72530430|NCT03091920|144590841|OTHER|No statistical testing was performed.|Least squares mean difference|-6.7|STANDARD_ERROR_OF_MEAN|5.5|||TWO_SIDED|95.0|-18.1|4.7|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 6 predose AM||4.7|-18.1|
72530431|NCT03091920|144590841|OTHER|No statistical testing was performed.|Least squares mean difference|-4.3|STANDARD_ERROR_OF_MEAN|5.1|||TWO_SIDED|95.0|-14.8|6.3|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 6 predose AM||6.3|-14.8|
72625679|NCT01198587|144780854|SUPERIORITY|||||||0.88|||||||Log Rank|||||||0.88
72625680|NCT01198587|144780854|SUPERIORITY|||||||0.19|||||||Log Rank|||||||0.19
72625681|NCT02008617|144780897|SUPERIORITY_OR_OTHER|||||||0.18|||||||Wilcoxon (Mann-Whitney)|||||||0.18
72625682|NCT02008617|144780898|SUPERIORITY_OR_OTHER|||||||0.86|||||||Wilcoxon (Mann-Whitney)|||At Rest||||0.86
72625683|NCT02008617|144780898|SUPERIORITY_OR_OTHER|||||||0.89|||||||Wilcoxon (Mann-Whitney)|||Plantar Flexion||||0.89
72625684|NCT02008617|144780899|SUPERIORITY_OR_OTHER|||||||0.78|||||||Wilcoxon (Mann-Whitney)|||||||0.78
72625685|NCT02008617|144780900|SUPERIORITY_OR_OTHER|||||||0.82|||||||Wilcoxon (Mann-Whitney)|||||||0.82
72530432|NCT03091920|144590841|OTHER|No statistical testing was performed.|Least squares mean difference|1.0|STANDARD_ERROR_OF_MEAN|6.3|||TWO_SIDED|95.0|-12.2|14.1|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7 predose AM||14.1|-12.2|
72530433|NCT03091920|144590841|OTHER|No statistical testing was performed.|Least squares mean difference|-3.8|STANDARD_ERROR_OF_MEAN|5.9|||TWO_SIDED|95.0|-16.0|8.4|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7 predose AM||8.4|-16.0|
72530434|NCT03091920|144590841|OTHER|No statistical testing was performed.|Least squares mean difference|-3.0|STANDARD_ERROR_OF_MEAN|5.8|||TWO_SIDED|95.0|-15.1|9.1|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7 postdose AM 1 hour||9.1|-15.1|
72530435|NCT03091920|144590841|OTHER|No statistical testing was performed.|Least squares mean difference|-6.4|STANDARD_ERROR_OF_MEAN|5.4|||TWO_SIDED|95.0|-17.6|4.8|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7 postdose AM 1 hour||4.8|-17.6|
72530436|NCT03091920|144590841|OTHER|No statistical testing was performed.|Least squares mean difference|-9.5|STANDARD_ERROR_OF_MEAN|6.4|||TWO_SIDED|95.0|-22.7|3.7|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7 postdose AM 4 hour||3.7|-22.7|
72530437|NCT03091920|144590841|OTHER|No statistical testing was performed.|Least squares mean difference|-17.2|STANDARD_ERROR_OF_MEAN|5.9|||TWO_SIDED|95.0|-29.5|-5.0|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7 postdose AM 4 hour||-5.0|-29.5|
72530438|NCT03091920|144590841|OTHER|No statistical testing was performed.|Least squares mean difference|-11.7|STANDARD_ERROR_OF_MEAN|6.2|||TWO_SIDED|95.0|-24.4|1.1|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 8 predose AM||1.1|-24.4|
72530439|NCT03091920|144590841|OTHER|No statistical testing was performed.|Least squares mean difference|-8.3|STANDARD_ERROR_OF_MEAN|5.7|||TWO_SIDED|95.0|-20.2|3.5|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 8 predose AM||3.5|-20.2|
72530440|NCT03091920|144590841|OTHER|No statistical testing was performed.|Least squares mean difference|-13.4|STANDARD_ERROR_OF_MEAN|7.1|||TWO_SIDED|95.0|-28.1|1.4|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 8 postdose AM 1 hour||1.4|-28.1|
72530441|NCT03091920|144590841|OTHER|No statistical testing was performed.|Least squares mean difference|-10.3|STANDARD_ERROR_OF_MEAN|6.6|||TWO_SIDED|95.0|-24.0|3.3|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 8 postdose AM 1 hour||3.3|-24.0|
72530442|NCT03091920|144590841|OTHER|No statistical testing was performed.|Least squares mean difference|-10.1|STANDARD_ERROR_OF_MEAN|8.2|||TWO_SIDED|95.0|-27.0|6.9|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 8 postdose AM 4 hour||6.9|-27.0|
72530443|NCT03091920|144590841|OTHER|No statistical testing was performed.|Least squares mean difference|-4.6|STANDARD_ERROR_OF_MEAN|7.6|||TWO_SIDED|95.0|-20.4|11.1|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 8 postdose AM 4 hour||11.1|-20.4|
72625686|NCT00619866|144780993|SUPERIORITY||LS Mean Difference|-0.31|STANDARD_ERROR_OF_MEAN|0.25||0.2311|TWO_SIDED|95.0|-0.81|0.2|||Repeated Measures Analysis of Covariance||Difference = Elagolix - Placebo|Change from baseline in in monthly mean values of the NRS for overall endometriosis-associated pelvic pain was analyzed by a repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for subject, and the baseline-by-time interaction, and the baseline value as a covariate.||0.20|-0.81|0.2311
72530444|NCT03091920|144590841|OTHER|No statistical testing was performed.|Least squares mean difference|-4.2|STANDARD_ERROR_OF_MEAN|7.3|||TWO_SIDED|95.0|-19.5|11.0|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 8 predose PM||11.0|-19.5|
72530445|NCT03091920|144590841|OTHER|No statistical testing was performed.|Least squares mean difference|-1.3|STANDARD_ERROR_OF_MEAN|6.8|||TWO_SIDED|95.0|-15.4|12.8|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 8 predose PM||12.8|-15.4|
72530446|NCT03091920|144590841|OTHER|No statistical testing was performed.|Least squares mean difference|-12.7|STANDARD_ERROR_OF_MEAN|5.0|||TWO_SIDED|95.0|-23.0|-2.5|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 9 predose AM||-2.5|-23.0|
72530447|NCT03091920|144590841|OTHER|No statistical testing was performed.|Least squares mean difference|-5.2|STANDARD_ERROR_OF_MEAN|4.6|||TWO_SIDED|95.0|-14.7|4.3|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 9 predose AM||4.3|-14.7|
72530448|NCT03091920|144590841|OTHER|No statistical testing was performed.|Least squares mean difference|-8.0|STANDARD_ERROR_OF_MEAN|5.3|||TWO_SIDED|95.0|-19.0|2.9|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 10 predose AM||2.9|-19.0|
72530449|NCT03091920|144590841|OTHER|No statistical testing was performed.|Least squares mean difference|-3.8|STANDARD_ERROR_OF_MEAN|4.9|||TWO_SIDED|95.0|-14.0|6.3|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 10 predose||6.3|-14.0|
72530450|NCT03091920|144590841|OTHER|No statistical testing was performed.|Least squares mean difference|-16.1|STANDARD_ERROR_OF_MEAN|7.2|||TWO_SIDED|95.0|-31.0|-1.2|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 11 predose AM||-1.2|-31.0|
72530451|NCT03091920|144590841|OTHER|No statistical testing was performed.|Least squares mean difference|-8.3|STANDARD_ERROR_OF_MEAN|6.7|||TWO_SIDED|95.0|-22.1|5.6|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 11 predose AM||5.6|-22.1|
72530452|NCT03091920|144590841|OTHER|No statistical testing was performed.|Least squares mean difference|-3.4|STANDARD_ERROR_OF_MEAN|5.4|||TWO_SIDED|95.0|-14.6|7.9|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 12 predose AM||7.9|-14.6|
72530453|NCT03091920|144590841|OTHER|No statistical testing was performed.|Least squares mean difference|-5.5|STANDARD_ERROR_OF_MEAN|5.0|||TWO_SIDED|95.0|-15.9|4.9|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 12 predose AM||4.9|-15.9|
72530454|NCT03091920|144590841|OTHER|No statistical testing was performed.|Least squares mean difference|-11.9|STANDARD_ERROR_OF_MEAN|4.9|||TWO_SIDED|95.0|-22.1|-1.7|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 13 predose AM||-1.7|-22.1|
72530455|NCT03091920|144590841|OTHER|No statistical testing was performed.|Least squares mean difference|-6.5|STANDARD_ERROR_OF_MEAN|4.6|||TWO_SIDED|95.0|-16.0|2.9|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 13 predose AM||2.9|-16.0|
72530456|NCT03091920|144590841|OTHER|No statistical testing was performed.|Least squares mean difference|-14.3|STANDARD_ERROR_OF_MEAN|5.4|||TWO_SIDED|95.0|-25.4|-3.2|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 13 postdose AM 1 hour||-3.2|-25.4|
72530457|NCT03091920|144590841|OTHER|No statistical testing was performed.|Least squares mean difference|-11.8|STANDARD_ERROR_OF_MEAN|5.0|||TWO_SIDED|95.0|-22.1|-1.5|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 13 postdose AM 1 hour||-1.5|-22.1|
72530458|NCT03091920|144590841|OTHER|No statistical testing was performed.|Least squares mean difference|-11.7|STANDARD_ERROR_OF_MEAN|8.4|||TWO_SIDED|95.0|-29.0|5.6|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 13 postdose AM 4 hour||5.6|-29.0|
72530459|NCT03091920|144590841|OTHER|No statistical testing was performed.|Least squares mean difference|-9.8|STANDARD_ERROR_OF_MEAN|7.7|||TWO_SIDED|95.0|-25.9|6.2|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 13 postdose AM 4 hour||6.2|-25.9|
72530460|NCT03091920|144590841|OTHER|No statistical testing was performed.|Least squares mean difference|-11.3|STANDARD_ERROR_OF_MEAN|5.4|||TWO_SIDED|95.0|-22.4|-0.1|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 13 postdose PM||-0.1|-22.4|
72530461|NCT03091920|144590841|OTHER|No statistical testing was performed.|Least squares mean difference|-9.9|STANDARD_ERROR_OF_MEAN|5.0|||TWO_SIDED|95.0|-20.2|0.4|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 13 predose PM||0.4|-20.2|
72530462|NCT03091920|144590841|OTHER|No statistical testing was performed.|Least squares mean difference|-5.8|STANDARD_ERROR_OF_MEAN|7.8|||TWO_SIDED|95.0|-22.0|10.5|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14 predose AM||10.5|-22.0|
72530463|NCT03091920|144590841|OTHER|No statistical testing was performed.|Least squares mean difference|-6.1|STANDARD_ERROR_OF_MEAN|7.3|||TWO_SIDED|95.0|-21.1|9.0|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14 predose AM||9.0|-21.1|
72530464|NCT03091920|144590841|OTHER|No statistical testing was performed.|Least squares mean difference|-8.1|STANDARD_ERROR_OF_MEAN|6.6|||TWO_SIDED|95.0|-21.7|5.6|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 15 / Discharge||5.6|-21.7|
72530465|NCT03091920|144590841|OTHER|No statistical testing was performed.|Least squares mean difference|-5.0|STANDARD_ERROR_OF_MEAN|6.1|||TWO_SIDED|95.0|-17.7|7.6|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 15 / Discharge||7.6|-17.7|
72530466|NCT03091920|144590841|OTHER|No statistical testing was performed.|Least squares mean difference|4.8|STANDARD_ERROR_OF_MEAN|5.7|||TWO_SIDED|95.0|-7.0|16.7|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 21 / Follow-up||16.7|-7.0|
72530467|NCT03091920|144590841|OTHER|No statistical testing was performed.|Least squares mean difference|5.2|STANDARD_ERROR_OF_MEAN|5.3|||TWO_SIDED|95.0|-5.8|16.2|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 21 / Follow-up||16.2|-5.8|
72530468|NCT03091920|144590841|OTHER|No statistical testing was performed.|Least squares mean difference|5.5|STANDARD_ERROR_OF_MEAN|8.3|||TWO_SIDED|95.0|-11.7|22.6|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 42 / End of Trial||22.6|-11.7|
72530469|NCT03091920|144590841|OTHER|No statistical testing was performed.|Least squares mean difference|-4.5|STANDARD_ERROR_OF_MEAN|7.7|||TWO_SIDED|95.0|-20.4|11.4|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 42 / End of Trial||11.4|-20.4|
72530470|NCT03091920|144590842|OTHER|No statistical testing was performed.|Least squares mean difference|-2.6|STANDARD_ERROR_OF_MEAN|3.1|||TWO_SIDED|95.0|-8.9|3.8|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, post-dose AM 1 hour||3.8|-8.9|
72530471|NCT03091920|144590842|OTHER|No statistical testing was performed.|Least squares mean difference|-2.0|STANDARD_ERROR_OF_MEAN|3.1|||TWO_SIDED|95.0|-8.4|4.5|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, post-dose AM 1 hour||4.5|-8.4|
72530472|NCT03091920|144590842|OTHER|No statistical testing was performed.|Least squares mean difference|-2.9|STANDARD_ERROR_OF_MEAN|3.1|||TWO_SIDED|95.0|-9.2|3.4|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, post-dose AM 4 hour||3.4|-9.2|
72530473|NCT03091920|144590842|OTHER|No statistical testing was performed.|Least squares mean difference|-7.1|STANDARD_ERROR_OF_MEAN|3.1|||TWO_SIDED|95.0|-13.5|-0.6|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, post-dose AM 4 hour||-0.6|-13.5|
72530474|NCT03091920|144590842|OTHER|No statistical testing was performed.|Least squares mean difference|-5.5|STANDARD_ERROR_OF_MEAN|2.9|||TWO_SIDED|95.0|-11.5|0.6|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, post-dose AM 8 hour||0.6|-11.5|
72530475|NCT03091920|144590842|OTHER|No statistical testing was performed.|Least squares mean difference|-4.6|STANDARD_ERROR_OF_MEAN|3.0|||TWO_SIDED|95.0|-10.8|1.5|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, post-dose AM 8 hour||1.5|-10.8|
72530476|NCT03091920|144590842|OTHER|No statistical testing was performed.|Least squares mean difference|-3.6|STANDARD_ERROR_OF_MEAN|2.8|||TWO_SIDED|95.0|-9.4|2.2|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, pre-dose PM||2.2|-9.4|
72530477|NCT03091920|144590842|OTHER|No statistical testing was performed.|Least squares mean difference|-2.1|STANDARD_ERROR_OF_MEAN|2.8|||TWO_SIDED|95.0|-8.0|3.7|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, pre-dose PM||3.7|-8.0|
72530478|NCT03091920|144590842|OTHER|No statistical testing was performed.|Least squares mean difference|-5.0|STANDARD_ERROR_OF_MEAN|4.3|||TWO_SIDED|95.0|-13.8|3.9|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, post-dose PM 1 hour||3.9|-13.8|
72530479|NCT03091920|144590842|OTHER|No statistical testing was performed.|Least squares mean difference|-2.7|STANDARD_ERROR_OF_MEAN|4.3|||TWO_SIDED|95.0|-11.7|6.2|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, post-dose PM 1 hour||6.2|-11.7|
72530480|NCT03091920|144590842|OTHER|No statistical testing was performed.|Least squares mean difference|-4.4|STANDARD_ERROR_OF_MEAN|2.5|||TWO_SIDED|95.0|-9.7|0.9|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 2, pre-dose AM||0.9|-9.7|
72530481|NCT03091920|144590842|OTHER|No statistical testing was performed.|Least squares mean difference|-3.1|STANDARD_ERROR_OF_MEAN|2.6|||TWO_SIDED|95.0|-8.5|2.2|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 2, pre-dose AM||2.2|-8.5|
72530482|NCT03091920|144590842|OTHER|No statistical testing was performed.|Least squares mean difference|-6.7|STANDARD_ERROR_OF_MEAN|3.1|||TWO_SIDED|95.0|-13.1|-0.3|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 2, post-dose AM 1 hour||-0.3|-13.1|
72530483|NCT03091920|144590842|OTHER|No statistical testing was performed.|Least squares mean difference|-5.3|STANDARD_ERROR_OF_MEAN|3.1|||TWO_SIDED|95.0|-11.8|1.2|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 2, post-dose AM 1 hour||1.2|-11.8|
72530484|NCT03091920|144590842|OTHER|No statistical testing was performed.|Least squares mean difference|-5.4|STANDARD_ERROR_OF_MEAN|4.3|||TWO_SIDED|95.0|-14.2|3.5|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 2, post-dose AM 4 hour||3.5|-14.2|
72530485|NCT03091920|144590842|OTHER|No statistical testing was performed.|Least squares mean difference|-8.5|STANDARD_ERROR_OF_MEAN|4.3|||TWO_SIDED|95.0|-17.5|0.5|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 2, post-dose AM 4 hour||0.5|-17.5|
72530486|NCT03091920|144590842|OTHER|No statistical testing was performed.|Least squares mean difference|-5.7|STANDARD_ERROR_OF_MEAN|2.9|||TWO_SIDED|95.0|-11.6|0.2|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 2, pre-dose PM||0.2|-11.6|
72530487|NCT03091920|144590842|OTHER|No statistical testing was performed.|Least squares mean difference|-4.6|STANDARD_ERROR_OF_MEAN|2.9|||TWO_SIDED|95.0|-10.6|1.5|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 2, pre-dose PM||1.5|-10.6|
72530488|NCT03091920|144590842|OTHER|No statistical testing was performed.|Least squares mean difference|-0.5|STANDARD_ERROR_OF_MEAN|3.3|||TWO_SIDED|95.0|-7.4|6.4|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 2, post-dose PM 1 hour||6.4|-7.4|
72530489|NCT03091920|144590842|OTHER|No statistical testing was performed.|Least squares mean difference|-2.3|STANDARD_ERROR_OF_MEAN|3.4|||TWO_SIDED|95.0|-9.3|4.7|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 2, post-dose PM 1 hour||4.7|-9.3|
72530490|NCT03091920|144590842|OTHER|No statistical testing was performed.|Least squares mean difference|-2.4|STANDARD_ERROR_OF_MEAN|3.4|||TWO_SIDED|95.0|-9.4|4.6|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 2, post-dose PM 4 hour||4.6|-9.4|
72530491|NCT03091920|144590842|OTHER|No statistical testing was performed.|Least squares mean difference|-1.5|STANDARD_ERROR_OF_MEAN|3.4|||TWO_SIDED|95.0|-8.7|5.6|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 2, post-dose PM 4 hour||5.6|-8.7|
72530492|NCT03091920|144590842|OTHER|No statistical testing was performed.|Least squares mean difference|0.2|STANDARD_ERROR_OF_MEAN|3.1|||TWO_SIDED|95.0|-6.2|6.7|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 3, pre-dose AM||6.7|-6.2|
72530493|NCT03091920|144590842|OTHER|No statistical testing was performed.|Least squares mean difference|0.3|STANDARD_ERROR_OF_MEAN|3.1|||TWO_SIDED|95.0|-6.2|6.8|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 3, pre-dose AM||6.8|-6.2|
72530494|NCT03091920|144590842|OTHER|No statistical testing was performed.|Least squares mean difference|1.5|STANDARD_ERROR_OF_MEAN|3.8|||TWO_SIDED|95.0|-6.4|9.4|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 3, post-dose PM 4 hour||9.4|-6.4|
72530495|NCT03091920|144590842|OTHER|No statistical testing was performed.|Least squares mean difference|-1.3|STANDARD_ERROR_OF_MEAN|3.9|||TWO_SIDED|95.0|-9.3|6.8|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 3, post-dose PM 4 hour||6.8|-9.3|
72530496|NCT03091920|144590842|OTHER|No statistical testing was performed.|Least squares mean difference|-4.3|STANDARD_ERROR_OF_MEAN|2.8|||TWO_SIDED|95.0|-10.0|1.4|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 4, pre-dose AM||1.4|-10.0|
72530497|NCT03091920|144590842|OTHER|No statistical testing was performed.|Least squares mean difference|-4.5|STANDARD_ERROR_OF_MEAN|2.8|||TWO_SIDED|95.0|-10.3|1.3|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 4, pre-dose AM||1.3|-10.3|
72530498|NCT03091920|144590842|OTHER|No statistical testing was performed.|Least squares mean difference|-2.4|STANDARD_ERROR_OF_MEAN|2.8|||TWO_SIDED|95.0|-8.2|3.3|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 5, pre-dose AM||3.3|-8.2|
72530499|NCT03091920|144590842|OTHER|No statistical testing was performed.|Least squares mean difference|-7.1|STANDARD_ERROR_OF_MEAN|2.8|||TWO_SIDED|95.0|-13.0|-1.3|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 5, pre-dose AM||-1.3|-13.0|
72530500|NCT03091920|144590842|OTHER|No statistical testing was performed.|Least squares mean difference|-2.8|STANDARD_ERROR_OF_MEAN|2.4|||TWO_SIDED|95.0|-7.7|2.2|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 6, pre-dose AM||2.2|-7.7|
72530501|NCT03091920|144590842|OTHER|No statistical testing was performed.|Least squares mean difference|-4.7|STANDARD_ERROR_OF_MEAN|2.4|||TWO_SIDED|95.0|-9.7|0.3|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 6, pre-dose AM||0.3|-9.7|
72571985|NCT02912650|144671809|SUPERIORITY_OR_OTHER||LS Mean Difference|5.37|||<|0.001|TWO_SIDED|95.0|4.1|6.63|||ANCOVA|||0 to 2 hours: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||6.63|4.10|<0.001
72530502|NCT03091920|144590842|OTHER|No statistical testing was performed.|Least squares mean difference|-4.1|STANDARD_ERROR_OF_MEAN|3.6|||TWO_SIDED|95.0|-11.6|3.5|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, pre-dose AM||3.5|-11.6|
72571986|NCT02912650|144671809|SUPERIORITY_OR_OTHER||LS Mean Difference|0.58||||0.203|TWO_SIDED|95.0|-0.31|1.47|||ANCOVA|||0 to 2 hours: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||1.47|-0.31|0.203
72530503|NCT03091920|144590842|OTHER|No statistical testing was performed.|Least squares mean difference|-4.3|STANDARD_ERROR_OF_MEAN|3.7|||TWO_SIDED|95.0|-12.0|3.3|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, pre-dose AM||3.3|-12.0|
72530504|NCT03091920|144590842|OTHER|No statistical testing was performed.|Least squares mean difference|-4.3|STANDARD_ERROR_OF_MEAN|3.0|||TWO_SIDED|95.0|-10.6|1.9|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, post-dose AM 1 hour||1.9|-10.6|
72530505|NCT03091920|144590842|OTHER|No statistical testing was performed.|Least squares mean difference|-5.7|STANDARD_ERROR_OF_MEAN|3.1|||TWO_SIDED|95.0|-12.0|0.7|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, post-dose AM 1 hour||0.7|-12.0|
72530506|NCT03091920|144590842|OTHER|No statistical testing was performed.|Least squares mean difference|1.0|STANDARD_ERROR_OF_MEAN|4.5|||TWO_SIDED|95.0|-8.3|10.3|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, post-dose AM 4 hour||10.3|-8.3|
72530507|NCT03091920|144590842|OTHER|No statistical testing was performed.|Least squares mean difference|0.2|STANDARD_ERROR_OF_MEAN|4.5|||TWO_SIDED|95.0|-9.2|9.7|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, post-dose AM 4 hour||9.7|-9.2|
72530508|NCT03091920|144590842|OTHER|No statistical testing was performed.|Least squares mean difference|-4.6|STANDARD_ERROR_OF_MEAN|3.3|||TWO_SIDED|95.0|-11.5|2.3|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 8, pre-dose AM||2.3|-11.5|
72530509|NCT03091920|144590842|OTHER|No statistical testing was performed.|Least squares mean difference|-2.9|STANDARD_ERROR_OF_MEAN|3.4|||TWO_SIDED|95.0|-9.9|4.2|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 8, pre-dose AM||4.2|-9.9|
72530510|NCT03091920|144590842|OTHER|No statistical testing was performed.|Least squares mean difference|-9.3|STANDARD_ERROR_OF_MEAN|3.0|||TWO_SIDED|95.0|-15.5|-3.0|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 8, post-dose AM 1 hour||-3.0|-15.5|
72530511|NCT03091920|144590842|OTHER|No statistical testing was performed.|Least squares mean difference|-8.3|STANDARD_ERROR_OF_MEAN|3.1|||TWO_SIDED|95.0|-14.6|-1.9|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 8, post-dose AM 1 hour||-1.9|-14.6|
72530512|NCT03091920|144590842|OTHER|No statistical testing was performed.|Least squares mean difference|-5.3|STANDARD_ERROR_OF_MEAN|3.5|||TWO_SIDED|95.0|-12.6|2.0|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 8, post-dose AM 4 hour||2.0|-12.6|
72571987|NCT02912650|144671809|SUPERIORITY_OR_OTHER||LS Mean Difference|24.5|||<|0.001|TWO_SIDED|95.0|20.1|28.9|||ANCOVA|||0 to 6 hours: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||28.90|20.10|<0.001
72530513|NCT03091920|144590842|OTHER|No statistical testing was performed.|Least squares mean difference|-1.3|STANDARD_ERROR_OF_MEAN|3.6|||TWO_SIDED|95.0|-8.7|6.1|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 8, post-dose AM 4 hour||6.1|-8.7|
72530514|NCT03091920|144590842|OTHER|No statistical testing was performed.|Least squares mean difference|-0.7|STANDARD_ERROR_OF_MEAN|3.6|||TWO_SIDED|95.0|-8.2|6.7|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 8, pre-dose PM||6.7|-8.2|
72530515|NCT03091920|144590842|OTHER|No statistical testing was performed.|Least squares mean difference|0.3|STANDARD_ERROR_OF_MEAN|3.7|||TWO_SIDED|95.0|-7.3|7.9|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 8, pre-dose PM||7.9|-7.3|
72530516|NCT03091920|144590842|OTHER|No statistical testing was performed.|Least squares mean difference|-4.9|STANDARD_ERROR_OF_MEAN|2.6|||TWO_SIDED|95.0|-10.3|0.6|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 9, pre-dose AM||0.6|-10.3|
72530517|NCT03091920|144590842|OTHER|No statistical testing was performed.|Least squares mean difference|-2.2|STANDARD_ERROR_OF_MEAN|2.7|||TWO_SIDED|95.0|-7.7|3.4|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 9, pre-dose AM||3.4|-7.7|
72530518|NCT03091920|144590842|OTHER|No statistical testing was performed.|Least squares mean difference|-3.9|STANDARD_ERROR_OF_MEAN|3.0|||TWO_SIDED|95.0|-10.0|2.3|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 10, pre-dose||2.3|-10.0|
72530519|NCT03091920|144590842|OTHER|No statistical testing was performed.|Least squares mean difference|-5.1|STANDARD_ERROR_OF_MEAN|3.0|||TWO_SIDED|95.0|-11.4|1.2|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 10, pre-dose AM||1.2|-11.4|
72530520|NCT03091920|144590842|OTHER|No statistical testing was performed.|Least squares mean difference|-8.7|STANDARD_ERROR_OF_MEAN|3.2|||TWO_SIDED|95.0|-15.2|-2.2|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 11, pre-dose AM||-2.2|-15.2|
72530521|NCT03091920|144590842|OTHER|No statistical testing was performed.|Least squares mean difference|-5.3|STANDARD_ERROR_OF_MEAN|3.2|||TWO_SIDED|95.0|-12.0|1.3|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 11, pre-dose AM||1.3|-12.0|
72530522|NCT03091920|144590842|OTHER|No statistical testing was performed.|Least squares mean difference|-2.4|STANDARD_ERROR_OF_MEAN|2.5|||TWO_SIDED|95.0|-7.6|2.8|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 12, pre-dose AM||2.8|-7.6|
72530523|NCT03091920|144590842|OTHER|No statistical testing was performed.|Least squares mean difference|-4.5|STANDARD_ERROR_OF_MEAN|2.5|||TWO_SIDED|95.0|-9.7|0.8|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 12, pre-dose AM||0.8|-9.7|
72530524|NCT03091920|144590842|OTHER|No statistical testing was performed.|Least squares mean difference|-4.9|STANDARD_ERROR_OF_MEAN|2.8|||TWO_SIDED|95.0|-10.7|0.8|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 13, pre-dose AM||0.8|-10.7|
72530525|NCT03091920|144590842|OTHER|No statistical testing was performed.|Least squares mean difference|-4.6|STANDARD_ERROR_OF_MEAN|2.8|||TWO_SIDED|95.0|-10.4|1.3|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 13, pre-dose AM||1.3|-10.4|
72530526|NCT03091920|144590842|OTHER|No statistical testing was performed.|Least squares mean difference|-9.0|STANDARD_ERROR_OF_MEAN|2.7|||TWO_SIDED|95.0|-14.6|-3.4|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 13, post-dose AM 1 hour||-3.4|-14.6|
72530527|NCT03091920|144590842|OTHER|No statistical testing was performed.|Least squares mean difference|-8.5|STANDARD_ERROR_OF_MEAN|2.7|||TWO_SIDED|95.0|-14.2|-2.8|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 13, post-dose AM 1 hour||-2.8|-14.2|
72530528|NCT03091920|144590842|OTHER|No statistical testing was performed.|Least squares mean difference|-6.2|STANDARD_ERROR_OF_MEAN|3.7|||TWO_SIDED|95.0|-13.8|1.5|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 13, post-dose AM 4 hour||1.5|-13.8|
72530529|NCT03091920|144590842|OTHER|No statistical testing was performed.|Least squares mean difference|-6.5|STANDARD_ERROR_OF_MEAN|3.7|||TWO_SIDED|95.0|-14.3|1.2|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 13, post-dose AM 4 hour||1.2|-14.3|
72530530|NCT03091920|144590842|OTHER|No statistical testing was performed.|Least squares mean difference|-8.0|STANDARD_ERROR_OF_MEAN|3.4|||TWO_SIDED|95.0|-15.0|-1.0|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 13, pre-dose PM||-1.0|-15.0|
72530531|NCT03091920|144590842|OTHER|No statistical testing was performed.|Least squares mean difference|-7.1|STANDARD_ERROR_OF_MEAN|3.4|||TWO_SIDED|95.0|-14.2|0.0|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 13, pre-dose PM||0|-14.2|
72530532|NCT03091920|144590842|OTHER|No statistical testing was performed.|Least squares mean difference|-1.7|STANDARD_ERROR_OF_MEAN|3.9|||TWO_SIDED|95.0|-9.8|6.4|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14, pre-dose AM||6.4|-9.8|
72530533|NCT03091920|144590842|OTHER|No statistical testing was performed.|Least squares mean difference|0.3|STANDARD_ERROR_OF_MEAN|4.0|||TWO_SIDED|95.0|-8.0|8.5|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14, pre-dose AM||8.5|-8.0|
72530534|NCT03091920|144590842|OTHER|No statistical testing was performed.|Least squares mean difference|-2.6|STANDARD_ERROR_OF_MEAN|3.1|||TWO_SIDED|95.0|-9.0|3.7|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 15, Discharge||3.7|-9.0|
72625687|NCT00619866|144780993|SUPERIORITY||LS Mean Difference|-0.36|STANDARD_ERROR_OF_MEAN|0.25||0.1521|TWO_SIDED|95.0|-0.86|0.14|||Repeated Measures Analysis of Covariance||Difference = Elagolix - Placebo|Change from baseline in in monthly mean values of the NRS for overall endometriosis-associated pelvic pain was analyzed by a repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for subject, and the baseline-by-time interaction, and the baseline value as a covariate.||0.14|-0.86|0.1521
72625688|NCT00619866|144780994|SUPERIORITY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.24||0.2041|TWO_SIDED|95.0|-0.77|0.17|||Repeated Measures ANCOVA||Difference = Elagolix - Placebo|Analysis at week 4. Change from baseline in in monthly mean values of the NRS for overall endometriosis-associated pelvic pain was analyzed by a repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for subject, and the baseline-by-time interaction, and the baseline value as a covariate.||0.17|-0.77|0.2041
72530535|NCT03091920|144590842|OTHER|No statistical testing was performed.|Least squares mean difference|-0.7|STANDARD_ERROR_OF_MEAN|3.1|||TWO_SIDED|95.0|-7.1|5.8|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 15, Discharge||5.8|-7.1|
72530536|NCT03091920|144590842|OTHER|No statistical testing was performed.|Least squares mean difference|-0.8|STANDARD_ERROR_OF_MEAN|2.3|||TWO_SIDED|95.0|-5.5|3.9|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 21, Follow-up||3.9|-5.5|
72530537|NCT03091920|144590842|OTHER|No statistical testing was performed.|Least squares mean difference|0.2|STANDARD_ERROR_OF_MEAN|2.3|||TWO_SIDED|95.0|-4.6|4.9|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 21, Follow-up||4.9|-4.6|
72530538|NCT03091920|144590842|OTHER|No statistical testing was performed.|Least squares mean difference|2.1|STANDARD_ERROR_OF_MEAN|4.2|||TWO_SIDED|95.0|-6.5|10.7|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 42, End of trial||10.7|-6.5|
72530539|NCT03091920|144590842|OTHER|No statistical testing was performed.|Least squares mean difference|0.8|STANDARD_ERROR_OF_MEAN|4.2|||TWO_SIDED|95.0|-7.9|9.6|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 42, End of trial||9.6|-7.9|
72530540|NCT03091920|144590843|OTHER|No statistical testing was performed.|Least squares mean difference|6.2|STANDARD_ERROR_OF_MEAN|5.1|||TWO_SIDED|95.0|-4.4|16.8|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, post-dose AM 1 hour||16.8|-4.4|
72530541|NCT03091920|144590843|OTHER|No statistical testing was performed.|Least squares mean difference|9.1|STANDARD_ERROR_OF_MEAN|5.1|||TWO_SIDED|95.0|-1.5|19.8|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, post-dose AM 1 hour||19.8|-1.5|
72530542|NCT03091920|144590843|OTHER|No statistical testing was performed.|Least squares mean difference|0.0|STANDARD_ERROR_OF_MEAN|4.3|||TWO_SIDED|95.0|-9.0|9.0|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, post-dose AM 4 hour||9.0|-9.0|
72530543|NCT03091920|144590843|OTHER|No statistical testing was performed.|Least squares mean difference|4.4|STANDARD_ERROR_OF_MEAN|4.3|||TWO_SIDED|95.0|-4.6|13.4|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, post-dose AM 4 hour||13.4|-4.6|
72530544|NCT03091920|144590843|OTHER|No statistical testing was performed.|Least squares mean difference|-0.2|STANDARD_ERROR_OF_MEAN|3.5|||TWO_SIDED|95.0|-7.5|7.1|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, post-dose AM 8 hour||7.1|-7.5|
72530545|NCT03091920|144590843|OTHER|No statistical testing was performed.|Least squares mean difference|1.6|STANDARD_ERROR_OF_MEAN|3.5|||TWO_SIDED|95.0|-5.7|8.9|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, post-dose AM 8 hour||8.9|-5.7|
72530546|NCT03091920|144590843|OTHER|No statistical testing was performed.|Least squares mean difference|5.1|STANDARD_ERROR_OF_MEAN|3.4|||TWO_SIDED|95.0|-2.0|12.1|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, pre-dose PM||12.1|-2.0|
72530547|NCT03091920|144590843|OTHER|No statistical testing was performed.|Least squares mean difference|5.2|STANDARD_ERROR_OF_MEAN|3.4|||TWO_SIDED|95.0|-1.8|12.3|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, pre-dose PM||12.3|-1.8|
72530548|NCT03091920|144590843|OTHER|No statistical testing was performed.|Least squares mean difference|2.3|STANDARD_ERROR_OF_MEAN|3.5|||TWO_SIDED|95.0|-5.1|9.6|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, post-dose PM 1 hour||9.6|-5.1|
72407967|NCT04847674|144324258|OTHER||LS mean difference|-0.7||||0.4683|TWO_SIDED|95.0|-2.71|1.26|||Mixed Models Analysis||Change from baseline in ACT at Week 12: TEV-53275 Dose A versus Placebo|Analysis was performed using an MMRM with treatment group, week, randomization factors, and treatment group by week interaction as fixed effects, and baseline ACT as a covariate.||1.26|-2.71|0.4683
72407968|NCT04847674|144324258|OTHER||LS mean difference|-1.2||||0.2239|TWO_SIDED|95.0|-3.16|0.75|||Mixed Models Analysis||Change from baseline in ACT at Week 12: TEV-53275 Dose B versus Placebo|Analysis was performed using an MMRM with treatment group, week, randomization factors, and treatment group by week interaction as fixed effects, and baseline ACT as a covariate.||0.75|-3.16|0.2239
72530549|NCT03091920|144590843|OTHER|No statistical testing was performed.|Least squares mean difference|1.3|STANDARD_ERROR_OF_MEAN|3.5|||TWO_SIDED|95.0|-6.0|8.7|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, post-dose PM 1 hour||8.7|-6.0|
72571988|NCT02912650|144671809|SUPERIORITY_OR_OTHER||LS Mean Difference|4.44||||0.005|TWO_SIDED|95.0|1.37|7.52|||ANCOVA|||0 to 6 hours: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||7.52|1.37|0.005
72571989|NCT02912650|144671809|SUPERIORITY_OR_OTHER||LS Mean Difference|11.36|||<|0.001|TWO_SIDED|95.0|8.23|14.48|||ANCOVA|||0 to 6 hours: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||14.48|8.23|<0.001
72407969|NCT04847674|144324258|OTHER||LS mean difference|-0.6||||0.5389|TWO_SIDED|95.0|-2.51|1.32|||Mixed Models Analysis||Change from baseline in ACT at Week 16: TEV-53275 Dose A versus Placebo|Analysis was performed using an MMRM with treatment group, week, randomization factors, and treatment group by week interaction as fixed effects, and baseline ACT as a covariate.||1.32|-2.51|0.5389
72530550|NCT03091920|144590843|OTHER|No statistical testing was performed.|Least squares mean difference|1.0|STANDARD_ERROR_OF_MEAN|2.9|||TWO_SIDED|95.0|-5.0|6.9|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 2, pre-dose AM||6.9|-5.0|
72530551|NCT03091920|144590843|OTHER|No statistical testing was performed.|Least squares mean difference|0.7|STANDARD_ERROR_OF_MEAN|2.9|||TWO_SIDED|95.0|-5.3|6.6|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 2, pre-dose AM||6.6|-5.3|
72530552|NCT03091920|144590843|OTHER|No statistical testing was performed.|Least squares mean difference|2.5|STANDARD_ERROR_OF_MEAN|5.1|||TWO_SIDED|95.0|-8.1|13.2|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 2, post-dose AM 1 hour||13.2|-8.1|
72530553|NCT03091920|144590843|OTHER|No statistical testing was performed.|Least squares mean difference|4.3|STANDARD_ERROR_OF_MEAN|5.1|||TWO_SIDED|95.0|-6.3|15.0|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 2, post-dose AM 1 hour||15.0|-6.3|
72530554|NCT03091920|144590843|OTHER|No statistical testing was performed.|Least squares mean difference|3.3|STANDARD_ERROR_OF_MEAN|3.8|||TWO_SIDED|95.0|-4.6|11.2|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 2, post-dose AM 4 hour||11.2|-4.6|
72530555|NCT03091920|144590843|OTHER|No statistical testing was performed.|Least squares mean difference|7.0|STANDARD_ERROR_OF_MEAN|3.8|||TWO_SIDED|95.0|-1.0|14.9|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 2, post-dose AM 4 hour||14.9|-1.0|
72530556|NCT03091920|144590843|OTHER|No statistical testing was performed.|Least squares mean difference|-1.3|STANDARD_ERROR_OF_MEAN|3.5|||TWO_SIDED|95.0|-8.5|5.9|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 2, pre-dose PM||5.9|-8.5|
72625689|NCT00619866|144780994|SUPERIORITY||LS Mean Difference|-0.23|STANDARD_ERROR_OF_MEAN|0.24||0.3375|TWO_SIDED|95.0|-0.69|0.24|||Repeated Measures ANCOVA||Difference = Elagolix - Placebo|Analysis at week 4. Change from baseline in in monthly mean values of the NRS for overall endometriosis-associated pelvic pain was analyzed by a repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for subject, and the baseline-by-time interaction, and the baseline value as a covariate.||0.24|-0.69|0.3375
72530557|NCT03091920|144590843|OTHER|No statistical testing was performed.|Least squares mean difference|-1.3|STANDARD_ERROR_OF_MEAN|3.5|||TWO_SIDED|95.0|-8.5|5.9|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 2, pre-dose PM||5.9|-8.5|
72530558|NCT03091920|144590843|OTHER|No statistical testing was performed.|Least squares mean difference|0.1|STANDARD_ERROR_OF_MEAN|4.5|||TWO_SIDED|95.0|-9.2|9.5|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 2, post-dose PM 1 hour||9.5|-9.2|
72571990|NCT02912650|144671809|SUPERIORITY_OR_OTHER||LS Mean Difference|20.06|||<|0.001|TWO_SIDED|95.0|15.66|24.45|||ANCOVA|||0 to 6 hours: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||24.45|15.66|<0.001
72530559|NCT03091920|144590843|OTHER|No statistical testing was performed.|Least squares mean difference|-0.2|STANDARD_ERROR_OF_MEAN|4.5|||TWO_SIDED|95.0|-9.5|9.2|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 2, post-dose PM 1 hour||9.2|-9.5|
72571991|NCT02912650|144671809|SUPERIORITY_OR_OTHER||LS Mean Difference|13.14|||<|0.001|TWO_SIDED|95.0|8.71|17.57|||ANCOVA|||0 to 6 hours: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||17.57|8.71|<0.001
72571992|NCT02912650|144671809|SUPERIORITY_OR_OTHER||LS Mean Difference|6.92|||<|0.001|TWO_SIDED|95.0|3.8|10.04|||ANCOVA|||0 to 6 hours: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||10.04|3.80|<0.001
72530560|NCT03091920|144590843|OTHER|No statistical testing was performed.|Least squares mean difference|1.2|STANDARD_ERROR_OF_MEAN|3.0|||TWO_SIDED|95.0|-5.1|7.4|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 2, post-dose PM 4 hour||7.4|-5.1|
72571993|NCT02912650|144671809|SUPERIORITY_OR_OTHER||LS Mean Difference|34.83|||<|0.001|TWO_SIDED|95.0|26.09|43.57|||ANCOVA|||0 to 12 hours: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||43.57|26.09|<0.001
72571994|NCT02912650|144671809|SUPERIORITY_OR_OTHER||LS Mean Difference|5.85||||0.06|TWO_SIDED|95.0|-0.25|11.95|||ANCOVA|||0 to 12 hours: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||11.95|-0.25|0.060
72530561|NCT03091920|144590843|OTHER|No statistical testing was performed.|Least squares mean difference|2.9|STANDARD_ERROR_OF_MEAN|3.0|||TWO_SIDED|95.0|-3.4|9.2|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 2, post-dose PM 4 hour||9.2|-3.4|
72530562|NCT03091920|144590843|OTHER|No statistical testing was performed.|Least squares mean difference|-1.4|STANDARD_ERROR_OF_MEAN|3.0|||TWO_SIDED|95.0|-7.5|4.8|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 3, pre-dose AM||4.8|-7.5|
72530563|NCT03091920|144590843|OTHER|No statistical testing was performed.|Least squares mean difference|-0.4|STANDARD_ERROR_OF_MEAN|3.0|||TWO_SIDED|95.0|-6.5|5.8|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 3, pre-dose AM||5.8|-6.5|
72530564|NCT03091920|144590843|OTHER|No statistical testing was performed.|Least squares mean difference|-2.3|STANDARD_ERROR_OF_MEAN|3.7|||TWO_SIDED|95.0|-9.9|5.3|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 3, post-dose PM 4 hour||5.3|-9.9|
72530565|NCT03091920|144590843|OTHER|No statistical testing was performed.|Least squares mean difference|2.2|STANDARD_ERROR_OF_MEAN|3.7|||TWO_SIDED|95.0|-5.4|9.8|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 3, post-dose PM 4 hour||9.8|-5.4|
72530566|NCT03091920|144590843|OTHER|No statistical testing was performed.|Least squares mean difference|7.0|STANDARD_ERROR_OF_MEAN|3.3|||TWO_SIDED|95.0|0.2|13.7|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 4, pre-dose AM||13.7|0.2|
72530567|NCT03091920|144590843|OTHER|No statistical testing was performed.|Least squares mean difference|5.0|STANDARD_ERROR_OF_MEAN|3.3|||TWO_SIDED|95.0|-1.7|11.8|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 4, pre-dose AM||11.8|-1.7|
72530568|NCT03091920|144590843|OTHER|No statistical testing was performed.|Least squares mean difference|2.9|STANDARD_ERROR_OF_MEAN|2.9|||TWO_SIDED|95.0|-3.1|9.0|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 5, pre-dose AM||9.0|-3.1|
72530569|NCT03091920|144590843|OTHER|No statistical testing was performed.|Least squares mean difference|2.6|STANDARD_ERROR_OF_MEAN|2.9|||TWO_SIDED|95.0|-3.4|8.7|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 5, pre-dose AM||8.7|-3.4|
72530570|NCT03091920|144590843|OTHER|No statistical testing was performed.|Least squares mean difference|2.3|STANDARD_ERROR_OF_MEAN|3.7|||TWO_SIDED|95.0|-5.4|10.0|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 6, pre-dose AM||10.0|-5.4|
72530571|NCT03091920|144590843|OTHER|No statistical testing was performed.|Least squares mean difference|-0.7|STANDARD_ERROR_OF_MEAN|3.7|||TWO_SIDED|95.0|-8.4|7.0|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 6, pre-dose AM||7.0|-8.4|
72530572|NCT03091920|144590843|OTHER|No statistical testing was performed.|Least squares mean difference|5.1|STANDARD_ERROR_OF_MEAN|3.2|||TWO_SIDED|95.0|-1.6|11.8|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, pre-dose AM||11.8|-1.6|
72530573|NCT03091920|144590843|OTHER|No statistical testing was performed.|Least squares mean difference|5.0|STANDARD_ERROR_OF_MEAN|3.2|||TWO_SIDED|95.0|-1.7|11.7|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, pre-dose AM||11.7|-1.7|
72530574|NCT03091920|144590843|OTHER|No statistical testing was performed.|Least squares mean difference|9.3|STANDARD_ERROR_OF_MEAN|5.2|||TWO_SIDED|95.0|-1.6|20.2|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, post-dose AM 1 hour||20.2|-1.6|
72530575|NCT03091920|144590843|OTHER|No statistical testing was performed.|Least squares mean difference|13.0|STANDARD_ERROR_OF_MEAN|5.3|||TWO_SIDED|95.0|2.1|23.9|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, post-dose AM 1 hour||23.9|2.1|
72530576|NCT03091920|144590843|OTHER|No statistical testing was performed.|Least squares mean difference|7.1|STANDARD_ERROR_OF_MEAN|3.3|||TWO_SIDED|95.0|0.2|13.9|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, post-dose AM 4 hour||13.9|0.2|
72530577|NCT03091920|144590843|OTHER|No statistical testing was performed.|Least squares mean difference|11.5|STANDARD_ERROR_OF_MEAN|3.3|||TWO_SIDED|95.0|4.6|18.3|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, post-dose AM 4 hour||18.3|4.6|
72530578|NCT03091920|144590843|OTHER|No statistical testing was performed.|Least squares mean difference|1.9|STANDARD_ERROR_OF_MEAN|3.2|||TWO_SIDED|95.0|-4.8|8.6|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 8, pre-dose AM||8.6|-4.8|
72530579|NCT03091920|144590843|OTHER|No statistical testing was performed.|Least squares mean difference|4.1|STANDARD_ERROR_OF_MEAN|3.2|||TWO_SIDED|95.0|-2.6|10.8|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 8, pre-dose||10.8|-2.6|
72530580|NCT03091920|144590843|OTHER|No statistical testing was performed.|Least squares mean difference|9.7|STANDARD_ERROR_OF_MEAN|4.7|||TWO_SIDED|95.0|-0.1|19.6|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 8, post-dose AM 1 hour||19.6|-0.1|
72530581|NCT03091920|144590843|OTHER|No statistical testing was performed.|Least squares mean difference|9.6|STANDARD_ERROR_OF_MEAN|4.7|||TWO_SIDED|95.0|-0.3|19.4|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 8, post-dose AM 1 hour||19.4|-0.3|
72530582|NCT03091920|144590843|OTHER|No statistical testing was performed.|Least squares mean difference|7.8|STANDARD_ERROR_OF_MEAN|3.7|||TWO_SIDED|95.0|0.0|15.5|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 8, post-dose AM 4 hour||15.5|0|
72530583|NCT03091920|144590843|OTHER|No statistical testing was performed.|Least squares mean difference|8.3|STANDARD_ERROR_OF_MEAN|3.7|||TWO_SIDED|95.0|0.6|16.1|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 8, post-dose AM 4 hour||16.1|0.6|
72530584|NCT03091920|144590843|OTHER|No statistical testing was performed.|Least squares mean difference|3.3|STANDARD_ERROR_OF_MEAN|4.0|||TWO_SIDED|95.0|-5.1|11.7|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 8, pre-dose PM||11.7|-5.1|
72530585|NCT03091920|144590843|OTHER|No statistical testing was performed.|Least squares mean difference|3.0|STANDARD_ERROR_OF_MEAN|4.0|||TWO_SIDED|95.0|-5.4|11.3|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 8, pre-dose PM||11.3|-5.4|
72530586|NCT03091920|144590843|OTHER|No statistical testing was performed.|Least squares mean difference|1.5|STANDARD_ERROR_OF_MEAN|3.7|||TWO_SIDED|95.0|-6.1|9.1|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 9, pre-dose AM||9.1|-6.1|
72530587|NCT03091920|144590843|OTHER|No statistical testing was performed.|Least squares mean difference|2.3|STANDARD_ERROR_OF_MEAN|3.7|||TWO_SIDED|95.0|-5.3|9.9|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 9, pre-dose AM||9.9|-5.3|
72530588|NCT03091920|144590843|OTHER|No statistical testing was performed.|Least squares mean difference|4.3|STANDARD_ERROR_OF_MEAN|4.0|||TWO_SIDED|95.0|-4.0|12.6|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 10, pre-dose||12.6|-4.0|
72530589|NCT03091920|144590843|OTHER|No statistical testing was performed.|Least squares mean difference|5.1|STANDARD_ERROR_OF_MEAN|4.0|||TWO_SIDED|95.0|-3.2|13.4|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 10, pre-dose AM||13.4|-3.2|
72530590|NCT03091920|144590843|OTHER|No statistical testing was performed.|Least squares mean difference|-1.5|STANDARD_ERROR_OF_MEAN|4.6|||TWO_SIDED|95.0|-11.0|8.0|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 11, pre-dose AM||8.0|-11.0|
72530591|NCT03091920|144590843|OTHER|No statistical testing was performed.|Least squares mean difference|-0.9|STANDARD_ERROR_OF_MEAN|4.6|||TWO_SIDED|95.0|-10.3|8.6|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 11, pre-dose AM||8.6|-10.3|
72530592|NCT03091920|144590843|OTHER|No statistical testing was performed.|Least squares mean difference|2.9|STANDARD_ERROR_OF_MEAN|5.1|||TWO_SIDED|95.0|-7.7|13.4|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 12, pre-dose AM||13.4|-7.7|
72530593|NCT03091920|144590843|OTHER|No statistical testing was performed.|Least squares mean difference|1.2|STANDARD_ERROR_OF_MEAN|5.1|||TWO_SIDED|95.0|-9.4|11.8|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 12, pre-dose AM||11.8|-9.4|
72530594|NCT03091920|144590843|OTHER|No statistical testing was performed.|Least squares mean difference|1.0|STANDARD_ERROR_OF_MEAN|4.5|||TWO_SIDED|95.0|-8.4|10.3|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 13, pre-dose AM||10.3|-8.4|
72530595|NCT03091920|144590843|OTHER|No statistical testing was performed.|Least squares mean difference|0.1|STANDARD_ERROR_OF_MEAN|4.5|||TWO_SIDED|95.0|-9.3|9.4|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 13, pre-dose AM||9.4|-9.3|
72530596|NCT03091920|144590843|OTHER|No statistical testing was performed.|Least squares mean difference|7.0|STANDARD_ERROR_OF_MEAN|4.0|||TWO_SIDED|95.0|-1.3|15.3|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 13, post-dose AM 1 hour||15.3|-1.3|
72530597|NCT03091920|144590843|OTHER|No statistical testing was performed.|Least squares mean difference|9.9|STANDARD_ERROR_OF_MEAN|4.0|||TWO_SIDED|95.0|1.6|18.2|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 13, post-dose AM 1 hour||18.2|1.6|
72530598|NCT03091920|144590843|OTHER|No statistical testing was performed.|Least squares mean difference|5.6|STANDARD_ERROR_OF_MEAN|3.2|||TWO_SIDED|95.0|-1.0|12.3|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 13, post-dose AM 4 hour||12.3|-1.0|
72530599|NCT03091920|144590843|OTHER|No statistical testing was performed.|Least squares mean difference|7.2|STANDARD_ERROR_OF_MEAN|3.2|||TWO_SIDED|95.0|0.5|13.9|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 13, post-dose AM 4 hour||13.9|0.5|
72530600|NCT03091920|144590843|OTHER|No statistical testing was performed.|Least squares mean difference|-0.5|STANDARD_ERROR_OF_MEAN|3.8|||TWO_SIDED|95.0|-8.4|7.4|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 13, pre-dose PM||7.4|-8.4|
72530601|NCT03091920|144590843|OTHER|No statistical testing was performed.|Least squares mean difference|1.9|STANDARD_ERROR_OF_MEAN|3.8|||TWO_SIDED|95.0|-6.0|9.9|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 13, pre-dose PM||9.9|-6.0|
72530602|NCT03091920|144590843|OTHER|No statistical testing was performed.|Least squares mean difference|3.9|STANDARD_ERROR_OF_MEAN|3.8|||TWO_SIDED|95.0|-4.0|11.8|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14, pre-dose AM||11.8|-4.0|
72530603|NCT03091920|144590843|OTHER|No statistical testing was performed.|Least squares mean difference|3.3|STANDARD_ERROR_OF_MEAN|3.8|||TWO_SIDED|95.0|-4.6|11.2|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14, pre-dose AM||11.2|-4.6|
72530604|NCT03091920|144590843|OTHER|No statistical testing was performed.|Least squares mean difference|-0.3|STANDARD_ERROR_OF_MEAN|3.7|||TWO_SIDED|95.0|-8.0|7.3|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 15, Discharge||7.3|-8.0|
72530605|NCT03091920|144590843|OTHER|No statistical testing was performed.|Least squares mean difference|0.5|STANDARD_ERROR_OF_MEAN|3.7|||TWO_SIDED|95.0|-7.2|8.1|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 15, Discharge||8.1|-7.2|
72530606|NCT03091920|144590843|OTHER|No statistical testing was performed.|Least squares mean difference|-0.7|STANDARD_ERROR_OF_MEAN|5.2|||TWO_SIDED|95.0|-11.5|10.2|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 21, Follow-up||10.2|-11.5|
72530607|NCT03091920|144590843|OTHER|No statistical testing was performed.|Least squares mean difference|6.7|STANDARD_ERROR_OF_MEAN|5.2|||TWO_SIDED|95.0|-4.1|17.5|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 21, Follow-up||17.5|-4.1|
72530608|NCT03091920|144590843|OTHER|No statistical testing was performed.|Least squares mean difference|0.3|STANDARD_ERROR_OF_MEAN|4.5|||TWO_SIDED|95.0|-9.1|9.6|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 42, End of trial||9.6|-9.1|
72530609|NCT03091920|144590843|OTHER|No statistical testing was performed.|Least squares mean difference|0.8|STANDARD_ERROR_OF_MEAN|4.5|||TWO_SIDED|95.0|-8.5|10.2|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 42, End of trial||10.2|-8.5|
72530610|NCT03091920|144590848|OTHER|No statistical testing was performed.|Least squares mean difference|-3.32|STANDARD_ERROR_OF_MEAN|3.07|||TWO_SIDED|95.0|-9.68|3.04|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. Standard Error of the Mean=Standard Error of the LS Mean Difference.|Day 1||3.04|-9.68|
72530611|NCT03091920|144590848|OTHER|No statistical testing was performed.|Least squares mean difference|-2.55|STANDARD_ERROR_OF_MEAN|2.99|||TWO_SIDED|95.0|-8.76|3.66|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. Standard Error of the Mean=Standard Error of the LS Mean Difference.|Day 1||3.66|-8.76|
72530612|NCT03091920|144590848|OTHER|No statistical testing was performed.|Least squares mean difference|-2.93|STANDARD_ERROR_OF_MEAN|2.74|||TWO_SIDED|95.0|-8.62|2.75|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. Standard Error of the Mean=Standard Error of the LS Mean Difference.|Day 1||2.75|-8.62|
72571995|NCT02912650|144671809|SUPERIORITY_OR_OTHER||LS Mean Difference|16.75|||<|0.001|TWO_SIDED|95.0|10.54|22.95|||ANCOVA|||0 to 12 hours: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||22.95|10.54|<0.001
72407970|NCT04847674|144324258|OTHER||LS mean difference|-0.9||||0.3564|TWO_SIDED|95.0|-2.75|1.0|||Mixed Models Analysis||Change from baseline in ACT at Week 16: TEV-53275 Dose B versus Placebo|Analysis was performed using an MMRM with treatment group, week, randomization factors, and treatment group by week interaction as fixed effects, and baseline ACT as a covariate.||1.00|-2.75|0.3564
72407971|NCT04847674|144324259|OTHER||LS mean difference|-0.2||||0.4436|TWO_SIDED|95.0|-0.62|0.27|||Mixed Models Analysis||Change from baseline in AQLQT at Week 12: TEV-53275 Dose A versus Placebo|Analysis was performed using an MMRM with treatment group, week, randomization factors, and treatment group by week interaction as fixed effects, and baseline AQLQ as a covariate.||0.27|-0.62|0.4436
72530613|NCT03091920|144590848|OTHER|No statistical testing was performed.|Least squares mean difference|-3.23|STANDARD_ERROR_OF_MEAN|3.44|||TWO_SIDED|95.0|-10.37|3.92|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. Standard Error of the Mean=Standard Error of the LS Mean Difference.|Day 7||3.92|-10.37|
72530614|NCT03091920|144590848|OTHER|No statistical testing was performed.|Least squares mean difference|0.52|STANDARD_ERROR_OF_MEAN|3.36|||TWO_SIDED|95.0|-6.46|7.49|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. Standard Error of the Mean=Standard Error of the LS Mean Difference.|Day 7||7.49|-6.46|
72530615|NCT03091920|144590848|OTHER|No statistical testing was performed.|Least squares mean difference|-1.36|STANDARD_ERROR_OF_MEAN|3.08|||TWO_SIDED|95.0|-7.74|5.03|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. Standard Error of the Mean=Standard Error of the LS Mean Difference.|Day 7||5.03|-7.74|
72530616|NCT03091920|144590848|OTHER|No statistical testing was performed.|Least squares mean difference|-2.71|STANDARD_ERROR_OF_MEAN|4.21|||TWO_SIDED|95.0|-11.46|6.04|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. Standard Error of the Mean=Standard Error of the LS Mean Difference.|Day 14||6.04|-11.46|
72530617|NCT03091920|144590848|OTHER|No statistical testing was performed.|Least squares mean difference|-1.87|STANDARD_ERROR_OF_MEAN|3.95|||TWO_SIDED|95.0|-10.09|6.35|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. Standard Error of the Mean=Standard Error of the LS Mean Difference.|Day 14||6.35|-10.09|
72530618|NCT03091920|144590848|OTHER|No statistical testing was performed.|Least squares mean difference|-2.29|STANDARD_ERROR_OF_MEAN|3.67|||TWO_SIDED|95.0|-9.93|5.35|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. Standard Error of the Mean=Standard Error of the LS Mean Difference.|Day 14||5.35|-9.93|
72530619|NCT03091920|144590849|OTHER|No statistical testing was performed.|Least squares mean difference|-7.06|STANDARD_ERROR_OF_MEAN|3.6|||TWO_SIDED|95.0|-14.52|0.4|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1||0.40|-14.52|
72571996|NCT02912650|144671809|SUPERIORITY_OR_OTHER||LS Mean Difference|28.98|||<|0.001|TWO_SIDED|95.0|20.26|37.71|||ANCOVA|||0 to 12 hours: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||37.71|20.26|<0.001
72571997|NCT02912650|144671809|SUPERIORITY_OR_OTHER||LS Mean Difference|18.08|||<|0.001||95.0|9.29|26.88|||ANCOVA|||0 to 12 hours: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||26.88|9.29|<0.001
72530620|NCT03091920|144590849|OTHER|No statistical testing was performed.|Least squares mean difference|-4.19|STANDARD_ERROR_OF_MEAN|3.54|||TWO_SIDED|95.0|-11.52|3.14|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1||3.14|-11.52|
72530621|NCT03091920|144590849|OTHER|No statistical testing was performed.|Least squares mean difference|-3.82|STANDARD_ERROR_OF_MEAN|3.69|||TWO_SIDED|95.0|-11.47|3.83|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7||3.83|-11.47|
72530622|NCT03091920|144590849|OTHER|No statistical testing was performed.|Least squares mean difference|1.42|STANDARD_ERROR_OF_MEAN|3.63|||TWO_SIDED|95.0|-6.1|8.94|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7||8.94|-6.10|
72530623|NCT03091920|144590849|OTHER|No statistical testing was performed.|Least squares mean difference|-6.44|STANDARD_ERROR_OF_MEAN|4.77|||TWO_SIDED|95.0|-16.36|3.47|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14||3.47|-16.36|
72530624|NCT03091920|144590849|OTHER|No statistical testing was performed.|Least squares mean difference|-1.03|STANDARD_ERROR_OF_MEAN|4.52|||TWO_SIDED|95.0|-10.44|8.38|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14||8.38|-10.44|
72530625|NCT03091920|144590850|OTHER|No statistical testing was performed.|Least squares mean difference|-0.22|STANDARD_ERROR_OF_MEAN|3.26|||TWO_SIDED|95.0|-6.97|6.54|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1||6.54|-6.97|
72530626|NCT03091920|144590850|OTHER|No statistical testing was performed.|Least squares mean difference|-1.6|STANDARD_ERROR_OF_MEAN|3.2|||TWO_SIDED|95.0|-8.24|5.03|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1||5.03|-8.24|
72530627|NCT03091920|144590850|OTHER|No statistical testing was performed.|Least squares mean difference|-3.12|STANDARD_ERROR_OF_MEAN|3.74|||TWO_SIDED|95.0|-10.88|4.65|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7||4.65|-10.88|
72530628|NCT03091920|144590850|OTHER|No statistical testing was performed.|Least squares mean difference|-0.82|STANDARD_ERROR_OF_MEAN|3.68|||TWO_SIDED|95.0|-8.45|6.8|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7||6.80|-8.45|
72530629|NCT03091920|144590850|OTHER|No statistical testing was performed.|Least squares mean difference|0.87|STANDARD_ERROR_OF_MEAN|4.19|||TWO_SIDED|95.0|-7.84|9.58|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14||9.58|-7.84|
72530630|NCT03091920|144590850|OTHER|No statistical testing was performed.|Least squares mean difference|-2.98|STANDARD_ERROR_OF_MEAN|3.96|||TWO_SIDED|95.0|-11.23|5.26|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14||5.26|-11.23|
72530631|NCT03091920|144590851|OTHER|No statistical testing was performed.|Least squares mean difference|-5.55|STANDARD_ERROR_OF_MEAN|3.84|||TWO_SIDED|95.0|-13.51|2.41|||||Least squares mean difference and associated 95% CI are from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, 0-4 hours||2.41|-13.51|
72530632|NCT03091920|144590851|OTHER|No statistical testing was performed.|Least squares mean difference|-2.47|STANDARD_ERROR_OF_MEAN|3.83|||TWO_SIDED|95.0|-10.41|5.47|||||Least squares mean difference and associated 95% CI are from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, 0-4 hours||5.47|-10.41|
72530633|NCT03091920|144590851|OTHER|No statistical testing was performed.|Least squares mean difference|-8.05|STANDARD_ERROR_OF_MEAN|4.49|||TWO_SIDED|95.0|-17.36|1.25|||||Least squares mean difference and associated 95% CI are from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, 4-8 hours||1.25|-17.36|
72530634|NCT03091920|144590851|OTHER|No statistical testing was performed.|Least squares mean difference|-8.28|STANDARD_ERROR_OF_MEAN|4.41|||TWO_SIDED|95.0|-17.42|0.87|||||Least squares mean difference and associated 95% CI are from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, 4-8 hours||0.87|-17.42|
72530635|NCT03091920|144590851|OTHER|No statistical testing was performed.|Least squares mean difference|-9.34|STANDARD_ERROR_OF_MEAN|4.86|||TWO_SIDED|95.0|-19.43|0.74|||||Least squares mean difference and associated 95% CI are from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, 8-12 hours||0.74|-19.43|
72530636|NCT03091920|144590851|OTHER|No statistical testing was performed.|Least squares mean difference|-3.05|STANDARD_ERROR_OF_MEAN|4.77|||TWO_SIDED|95.0|-12.95|6.84|||||Least squares mean difference and associated 95% CI are from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, 8-12 hours||6.84|-12.95|
72530637|NCT03091920|144590851|OTHER|No statistical testing was performed.|Least squares mean difference|3.36|STANDARD_ERROR_OF_MEAN|3.91|||TWO_SIDED|95.0|-4.74|11.47|||||Least squares mean difference and associated 95% CI are from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, 12-16 hours||11.47|-4.74|
72530638|NCT03091920|144590851|OTHER|No statistical testing was performed.|Least squares mean difference|2.82|STANDARD_ERROR_OF_MEAN|3.82|||TWO_SIDED|95.0|-5.1|10.75|||||Least squares mean difference and associated 95% CI are from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, 12-16 hours||10.75|-5.10|
72530639|NCT03091920|144590851|OTHER|No statistical testing was performed.|Least squares mean difference|-4.43|STANDARD_ERROR_OF_MEAN|5.21|||TWO_SIDED|95.0|-15.23|6.37|||||Least squares mean difference and associated 95% CI are from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, 16-20 hours||6.37|-15.23|
72530640|NCT03091920|144590851|OTHER|No statistical testing was performed.|Least squares mean difference|-4.85|STANDARD_ERROR_OF_MEAN|5.21|||TWO_SIDED|95.0|-15.65|5.94|||||Least squares mean difference and associated 95% CI are from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, 16-20 hours||5.94|-15.65|
72530641|NCT03091920|144590851|OTHER|No statistical testing was performed.|Least squares mean difference|-0.81|STANDARD_ERROR_OF_MEAN|4.0|||TWO_SIDED|95.0|-9.1|7.47|||||Least squares mean difference and associated 95% CI are from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, 20-24 hours||7.47|-9.10|
72530642|NCT03091920|144590851|OTHER|No statistical testing was performed.|Least squares mean difference|-2.63|STANDARD_ERROR_OF_MEAN|3.76|||TWO_SIDED|95.0|-10.42|5.16|||||Least squares mean difference and associated 95% CI are from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, 20-24 hours||5.16|-10.42|
72530643|NCT03091920|144590851|OTHER|No statistical testing was performed.|Least squares mean difference|-5.54|STANDARD_ERROR_OF_MEAN|3.98|||TWO_SIDED|95.0|-13.8|2.72|||||Least squares mean difference and associated 95% CI are from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, 0-4 hours||2.72|-13.80|
72530644|NCT03091920|144590851|OTHER|No statistical testing was performed.|Least squares mean difference|-0.01|STANDARD_ERROR_OF_MEAN|3.97|||TWO_SIDED|95.0|-8.25|8.23|||||Least squares mean difference and associated 95% CI are from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, 0-4 hours||8.23|-8.25|
72530645|NCT03091920|144590851|OTHER|No statistical testing was performed.|Least squares mean difference|-2.89|STANDARD_ERROR_OF_MEAN|4.4|||TWO_SIDED|95.0|-12.01|6.23|||||Least squares mean difference and associated 95% CI are from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, 4-8 hours||6.23|-12.01|
72530646|NCT03091920|144590851|OTHER|No statistical testing was performed.|Least squares mean difference|2.17|STANDARD_ERROR_OF_MEAN|4.32|||TWO_SIDED|95.0|-6.78|11.13|||||Least squares mean difference and associated 95% CI are from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, 4-8 hours||11.13|-6.78|
72530647|NCT03091920|144590851|OTHER|No statistical testing was performed.|Least squares mean difference|-4.23|STANDARD_ERROR_OF_MEAN|4.68|||TWO_SIDED|95.0|-13.93|5.47|||||Least squares mean difference and associated 95% CI are from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, 8-12 hours||5.47|-13.93|
72530648|NCT03091920|144590851|OTHER|No statistical testing was performed.|Least squares mean difference|1.37|STANDARD_ERROR_OF_MEAN|4.59|||TWO_SIDED|95.0|-8.14|10.88|||||Least squares mean difference and associated 95% CI are from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, 8-12 hours||10.88|-8.14|
72530649|NCT03091920|144590851|OTHER|No statistical testing was performed.|Least squares mean difference|-0.57|STANDARD_ERROR_OF_MEAN|4.7|||TWO_SIDED|95.0|-10.32|9.18|||||Least squares mean difference and associated 95% CI are from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, 12-16 hours||9.18|-10.32|
72530650|NCT03091920|144590851|OTHER|No statistical testing was performed.|Least squares mean difference|2.49|STANDARD_ERROR_OF_MEAN|4.6|||TWO_SIDED|95.0|-7.04|12.02|||||Least squares mean difference and associated 95% CI are from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, 12-16 hours||12.02|-7.04|
72530651|NCT03091920|144590851|OTHER|No statistical testing was performed.|Least squares mean difference|-7.89|STANDARD_ERROR_OF_MEAN|5.03|||TWO_SIDED|95.0|-18.33|2.55|||||Least squares mean difference and associated 95% CI are from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, 16-20 hours||2.55|-18.33|
72530652|NCT03091920|144590851|OTHER|No statistical testing was performed.|Least squares mean difference|-6.49|STANDARD_ERROR_OF_MEAN|5.03|||TWO_SIDED|95.0|-16.92|3.95|||||Least squares mean difference and associated 95% CI are from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, 16-20 hours||3.95|-16.92|
72625690|NCT00619866|144780994|SUPERIORITY||LS Mean Difference|-0.52|STANDARD_ERROR_OF_MEAN|0.25||0.0354|TWO_SIDED|95.0|-1.01|-0.04|||Repeated Measures ANCOVA||Difference = Elagolix - Placebo|Analysis at week 8. Change from baseline in in monthly mean values of the NRS for overall endometriosis-associated pelvic pain was analyzed by a repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for subject, and the baseline-by-time interaction, and the baseline value as a covariate.||-0.04|-1.01|0.0354
72530653|NCT03091920|144590851|OTHER|No statistical testing was performed.|Least squares mean difference|-3.84|STANDARD_ERROR_OF_MEAN|4.91|||TWO_SIDED|95.0|-14.03|6.35|||||Least squares mean difference and associated 95% CI are from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, 20-24 hours||6.35|-14.03|
72530654|NCT03091920|144590851|OTHER|No statistical testing was performed.|Least squares mean difference|0.78|STANDARD_ERROR_OF_MEAN|4.62|||TWO_SIDED|95.0|-8.8|10.35|||||Least squares mean difference and associated 95% CI are from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, 20-24 hours||10.35|-8.80|
72530655|NCT03091920|144590851|OTHER|No statistical testing was performed.|Least squares mean difference|-7.13|STANDARD_ERROR_OF_MEAN|5.12|||TWO_SIDED|95.0|-17.79|3.53|||||Least squares mean difference and associated 95% CI are from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14, 0-4 hours||3.53|-17.79|
72530656|NCT03091920|144590851|OTHER|No statistical testing was performed.|Least squares mean difference|1.66|STANDARD_ERROR_OF_MEAN|4.93|||TWO_SIDED|95.0|-8.59|11.91|||||Least squares mean difference and associated 95% CI are from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14, 0-4 hours||11.91|-8.59|
72530657|NCT03091920|144590851|OTHER|No statistical testing was performed.|Least squares mean difference|-6.31|STANDARD_ERROR_OF_MEAN|4.74|||TWO_SIDED|95.0|-16.17|3.55|||||Least squares mean difference and associated 95% CI are from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14, 4-8 hours||3.55|-16.17|
72530658|NCT03091920|144590851|OTHER|No statistical testing was performed.|Least squares mean difference|-1.17|STANDARD_ERROR_OF_MEAN|4.54|||TWO_SIDED|95.0|-10.6|8.27|||||Least squares mean difference and associated 95% CI are from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14, 4-8 hours||8.27|-10.60|
72625691|NCT00619866|144780994|SUPERIORITY||LS Mean Difference|-0.23|STANDARD_ERROR_OF_MEAN|0.25||0.3618|TWO_SIDED|95.0|-0.71|0.26|||Repeated Measures ANCOVA||Difference = Elagolix - Placebo|Analysis at week 8. Change from baseline in in monthly mean values of the NRS for overall endometriosis-associated pelvic pain was analyzed by a repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for subject, and the baseline-by-time interaction, and the baseline value as a covariate.||0.26|-0.71|0.3618
72530659|NCT03091920|144590851|OTHER|No statistical testing was performed.|Least squares mean difference|-7.01|STANDARD_ERROR_OF_MEAN|5.83|||TWO_SIDED|95.0|-19.13|5.11|||||Least squares mean difference and associated 95% CI are from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14, 8-12 hours||5.11|-19.13|
72530660|NCT03091920|144590851|OTHER|No statistical testing was performed.|Least squares mean difference|-4.11|STANDARD_ERROR_OF_MEAN|5.5|||TWO_SIDED|95.0|-15.55|7.34|||||Least squares mean difference and associated 95% CI are from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14, 8-12 hours||7.34|-15.55|
72530661|NCT03091920|144590851|OTHER|No statistical testing was performed.|Least squares mean difference|1.77|STANDARD_ERROR_OF_MEAN|5.48|||TWO_SIDED|95.0|-9.63|13.17|||||Least squares mean difference and associated 95% CI are from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14, 12-16 hours||13.17|-9.63|
72530662|NCT03091920|144590851|OTHER|No statistical testing was performed.|Least squares mean difference|-3.47|STANDARD_ERROR_OF_MEAN|5.18|||TWO_SIDED|95.0|-14.25|7.31|||||Least squares mean difference and associated 95% CI are from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14, 12-16 hours||7.31|-14.25|
72530663|NCT03091920|144590851|OTHER|No statistical testing was performed.|Least squares mean difference|-1.73|STANDARD_ERROR_OF_MEAN|4.57|||TWO_SIDED|95.0|-11.24|7.77|||||Least squares mean difference and associated 95% CI are from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14, 16-20 hours||7.77|-11.24|
72530664|NCT03091920|144590851|OTHER|No statistical testing was performed.|Least squares mean difference|-5.55|STANDARD_ERROR_OF_MEAN|4.46|||TWO_SIDED|95.0|-14.83|3.73|||||Least squares mean difference and associated 95% CI are from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14, 16-20 hours||3.73|-14.83|
72530665|NCT03091920|144590851|OTHER|No statistical testing was performed.|Least squares mean difference|1.98|STANDARD_ERROR_OF_MEAN|5.21|||TWO_SIDED|95.0|-8.85|12.81|||||Least squares mean difference and associated 95% CI are from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14, 20-24 hours||12.81|-8.85|
72530666|NCT03091920|144590851|OTHER|No statistical testing was performed.|Least squares mean difference|1.07|STANDARD_ERROR_OF_MEAN|4.69|||TWO_SIDED|95.0|-8.68|10.82|||||Least squares mean difference and associated 95% CI are from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14, 20-24 hours||10.82|-8.68|
72571998|NCT02912650|144671809|SUPERIORITY_OR_OTHER||LS Mean Difference|10.9|||<|0.001|TWO_SIDED|95.0|4.7|17.1|||ANCOVA|||0 to 12 hours: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||17.10|4.70|<0.001
72571999|NCT02912650|144671810|SUPERIORITY_OR_OTHER||LS Mean Difference|2.12|||<|0.001|TWO_SIDED|95.0|1.72|2.51|||ANOVA|||0-2 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||2.51|1.72|<0.001
72572000|NCT02912650|144671810|SUPERIORITY_OR_OTHER||LS Mean Difference|0.44||||0.002|TWO_SIDED|95.0|0.16|0.71|||ANOVA|||0-2 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.71|0.16|0.002
72625692|NCT00619866|144780995|SUPERIORITY||LS Mean Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.46||0.799|TWO_SIDED|95.0|-1.01|0.78|||Repeated Measures ANCOVA||Difference = Elagolix - Placebo|Analysis at week 4. Change from baseline in in monthly peak values of the NRS for overall endometriosis-associated pelvic pain was analyzed by a repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for subject, and the baseline-by-time interaction, and the baseline value as a covariate.||0.78|-1.01|0.7990
72530667|NCT03091920|144590852|OTHER|No statistical testing was performed.|Least squares mean difference|-2.12|STANDARD_ERROR_OF_MEAN|2.06|||TWO_SIDED|95.0|-6.38|2.15|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1||2.15|-6.38|
72572001|NCT02912650|144671810|SUPERIORITY_OR_OTHER||LS Mean Difference|0.58|||<|0.001|TWO_SIDED|95.0|0.3|0.86|||ANOVA|||0-2 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.86|0.30|<0.001
72572002|NCT02912650|144671810|SUPERIORITY_OR_OTHER||LS Mean Difference|1.68|||<|0.001|TWO_SIDED|95.0|1.29|2.08|||ANOVA|||0-2 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||2.08|1.29|<0.001
72572003|NCT02912650|144671810|SUPERIORITY_OR_OTHER||LS Mean Difference|1.53|||<|0.001|TWO_SIDED|95.0|1.14|1.93|||ANOVA|||0-2 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.93|1.14|<0.001
72572004|NCT02912650|144671810|SUPERIORITY_OR_OTHER||LS Mean Difference|0.15||||0.303|TWO_SIDED|95.0|-0.13|0.43|||ANOVA|||0-2 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.43|-0.13|0.303
72572005|NCT02912650|144671810|SUPERIORITY_OR_OTHER||LS Mean Difference|7.22|||<|0.001|TWO_SIDED|95.0|5.86|8.58|||ANOVA|||0-6 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||8.58|5.86|<0.001
72572006|NCT02912650|144671810|SUPERIORITY_OR_OTHER||LS Mean Difference|1.58||||0.001|TWO_SIDED|95.0|0.63|2.53|||ANOVA|||0-6 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||2.53|0.63|0.001
72572007|NCT02912650|144671810|SUPERIORITY_OR_OTHER||LS Mean Difference|3.48|||<|0.001|TWO_SIDED|95.0|2.52|4.45|||ANOVA|||0-6 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||4.45|2.52|<0.001
72572008|NCT02912650|144671810|SUPERIORITY_OR_OTHER||LS Mean Difference|5.64|||<|0.001|TWO_SIDED|95.0|4.28|6.99|||ANOVA|||0-6 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||6.99|4.28|<0.001
72572009|NCT02912650|144671810|SUPERIORITY_OR_OTHER||LS Mean Difference|3.73|||<|0.001|TWO_SIDED|95.0|2.37|5.1|||ANOVA|||0-6 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||5.10|2.37|<0.001
72625693|NCT00619866|144780995|SUPERIORITY||LS Mean Difference|-0.31|STANDARD_ERROR_OF_MEAN|0.46||0.5042|TWO_SIDED|95.0|-1.21|0.59|||Repeated Measures ANCOVA||Difference = Elagolix - Placebo|Analysis at week 4. Change from baseline in in monthly peak values of the NRS for overall endometriosis-associated pelvic pain was analyzed by a repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for subject, and the baseline-by-time interaction, and the baseline value as a covariate.||0.59|-1.21|0.5042
72530668|NCT03091920|144590852|OTHER|No statistical testing was performed.|Least squares mean difference|-2.39|STANDARD_ERROR_OF_MEAN|2.02|||TWO_SIDED|95.0|-6.59|1.8|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1||1.80|-6.59|
72530669|NCT03091920|144590852|OTHER|No statistical testing was performed.|Least squares mean difference|-2.26|STANDARD_ERROR_OF_MEAN|1.86|||TWO_SIDED|95.0|-6.11|1.6|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. Standard Error of the Mean=Standard Error of the LS Mean Difference.|Day 1||1.60|-6.11|
72530670|NCT03091920|144590852|OTHER|No statistical testing was performed.|Least squares mean difference|-3.39|STANDARD_ERROR_OF_MEAN|2.34|||TWO_SIDED|95.0|-8.25|1.47|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7||1.47|-8.25|
72530671|NCT03091920|144590852|OTHER|No statistical testing was performed.|Least squares mean difference|-1.61|STANDARD_ERROR_OF_MEAN|2.31|||TWO_SIDED|95.0|-6.4|3.18|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7||3.18|-6.40|
72530672|NCT03091920|144590852|OTHER|No statistical testing was performed.|Least squares mean difference|-2.5|STANDARD_ERROR_OF_MEAN|2.12|||TWO_SIDED|95.0|-6.9|1.9|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. Standard Error of the Mean=Standard Error of the LS Mean Difference.|Day 7||1.90|-6.90|
72530673|NCT03091920|144590852|OTHER|No statistical testing was performed.|Least squares mean difference|-4.96|STANDARD_ERROR_OF_MEAN|3.01|||TWO_SIDED|95.0|-11.22|1.31|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14||1.31|-11.22|
72530674|NCT03091920|144590852|OTHER|No statistical testing was performed.|Least squares mean difference|-4.5|STANDARD_ERROR_OF_MEAN|2.84|||TWO_SIDED|95.0|-10.41|1.4|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14||1.40|-10.41|
72530675|NCT03091920|144590852|OTHER|No statistical testing was performed.|Least squares mean difference|-4.73|STANDARD_ERROR_OF_MEAN|2.67|||TWO_SIDED|95.0|-10.27|0.81|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. Standard Error of the Mean=Standard Error of the LS Mean Difference.|Day 14||0.81|-10.27|
72530676|NCT03091920|144590853|OTHER|No statistical testing was performed.|Least squares mean difference|-4.87|STANDARD_ERROR_OF_MEAN|2.86|||TWO_SIDED|95.0|-10.8|1.06|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1||1.06|-10.80|
72530677|NCT03091920|144590853|OTHER|No statistical testing was performed.|Least squares mean difference|-5.02|STANDARD_ERROR_OF_MEAN|2.82|||TWO_SIDED|95.0|-10.87|0.83|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1||0.83|-10.87|
72530678|NCT03091920|144590853|OTHER|No statistical testing was performed.|Least squares mean difference|-4.23|STANDARD_ERROR_OF_MEAN|2.57|||TWO_SIDED|95.0|-9.55|1.1|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7||1.10|-9.55|
72407972|NCT04847674|144324259|OTHER||LS mean difference|-0.1||||0.597|TWO_SIDED|95.0|-0.56|0.32|||Mixed Models Analysis||Change from baseline in AQLQT at Week 12: TEV-53275 Dose B versus Placebo|Analysis was performed using an MMRM with treatment group, week, randomization factors, and treatment group by week interaction as fixed effects, and baseline AQLQ as a covariate.||0.32|-0.56|0.5970
72530679|NCT03091920|144590853|OTHER|No statistical testing was performed.|Least squares mean difference|-2.15|STANDARD_ERROR_OF_MEAN|2.53|||TWO_SIDED|95.0|-7.4|3.11|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7||3.11|-7.40|
72530680|NCT03091920|144590853|OTHER|No statistical testing was performed.|Least squares mean difference|-8.74|STANDARD_ERROR_OF_MEAN|3.31|||TWO_SIDED|95.0|-15.64|-1.85|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14||-1.85|-15.64|
72530681|NCT03091920|144590853|OTHER|No statistical testing was performed.|Least squares mean difference|-5.34|STANDARD_ERROR_OF_MEAN|3.12|||TWO_SIDED|95.0|-11.84|1.15|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14||1.15|-11.84|
72530682|NCT03091920|144590854|OTHER|No statistical testing was performed.|Least squares mean difference|-0.45|STANDARD_ERROR_OF_MEAN|2.13|||TWO_SIDED|95.0|-4.86|3.96|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1||3.96|-4.86|
72530683|NCT03091920|144590854|OTHER|No statistical testing was performed.|Least squares mean difference|-0.71|STANDARD_ERROR_OF_MEAN|2.1|||TWO_SIDED|95.0|-5.07|3.65|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1||3.65|-5.07|
72530684|NCT03091920|144590854|OTHER|No statistical testing was performed.|Least squares mean difference|-3.32|STANDARD_ERROR_OF_MEAN|2.64|||TWO_SIDED|95.0|-8.79|2.14|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7||2.14|-8.79|
72530685|NCT03091920|144590854|OTHER|No statistical testing was performed.|Least squares mean difference|-1.74|STANDARD_ERROR_OF_MEAN|2.61|||TWO_SIDED|95.0|-7.14|3.67|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7||3.67|-7.14|
72572010|NCT02912650|144671810|SUPERIORITY_OR_OTHER||LS Mean Difference|1.9|||<|0.001|TWO_SIDED|95.0|0.95|2.86|||ANOVA|||0-6 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||2.86|0.95|<0.001
72530686|NCT03091920|144590854|OTHER|No statistical testing was performed.|Least squares mean difference|-1.88|STANDARD_ERROR_OF_MEAN|3.22|||TWO_SIDED|95.0|-8.58|4.83|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14||4.83|-8.58|
72530687|NCT03091920|144590854|OTHER|No statistical testing was performed.|Least squares mean difference|-4.3|STANDARD_ERROR_OF_MEAN|3.08|||TWO_SIDED|95.0|-10.69|2.1|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14||2.10|-10.69|
72530688|NCT03091920|144590855|OTHER|No statistical testing was performed.|Least squares mean difference|-4.45|STANDARD_ERROR_OF_MEAN|3.31|||TWO_SIDED|95.0|-11.3|2.41|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, 0-4 hours||2.41|-11.30|
72530689|NCT03091920|144590855|OTHER|No statistical testing was performed.|Least squares mean difference|-5.17|STANDARD_ERROR_OF_MEAN|3.34|||TWO_SIDED|95.0|-12.1|1.75|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, 0-4 hours||1.75|-12.10|
72530690|NCT03091920|144590855|OTHER|No statistical testing was performed.|Least squares mean difference|-5.23|STANDARD_ERROR_OF_MEAN|3.69|||TWO_SIDED|95.0|-12.87|2.42|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, 4-8 hours||2.42|-12.87|
72530691|NCT03091920|144590855|OTHER|No statistical testing was performed.|Least squares mean difference|-8.22|STANDARD_ERROR_OF_MEAN|3.58|||TWO_SIDED|95.0|-15.64|-0.79|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, 4-8 hours||-0.79|-15.64|
72530692|NCT03091920|144590855|OTHER|No statistical testing was performed.|Least squares mean difference|-6.72|STANDARD_ERROR_OF_MEAN|3.65|||TWO_SIDED|95.0|-14.29|0.86|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, 8-12 hours||0.86|-14.29|
72530693|NCT03091920|144590855|OTHER|No statistical testing was performed.|Least squares mean difference|-3.14|STANDARD_ERROR_OF_MEAN|3.63|||TWO_SIDED|95.0|-10.66|4.38|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, 8-12 hours||4.38|-10.66|
72530694|NCT03091920|144590855|OTHER|No statistical testing was performed.|Least squares mean difference|0.37|STANDARD_ERROR_OF_MEAN|2.45|||TWO_SIDED|95.0|-4.71|5.45|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, 12-16 hours||5.45|-4.71|
72530695|NCT03091920|144590855|OTHER|No statistical testing was performed.|Least squares mean difference|-0.02|STANDARD_ERROR_OF_MEAN|2.37|||TWO_SIDED|95.0|-4.94|4.91|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, 12-16||4.91|-4.94|
72530696|NCT03091920|144590855|OTHER|No statistical testing was performed.|Least squares mean difference|-2.33|STANDARD_ERROR_OF_MEAN|3.73|||TWO_SIDED|95.0|-10.07|5.41|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, 16-20 hours||5.41|-10.07|
72530697|NCT03091920|144590855|OTHER|No statistical testing was performed.|Least squares mean difference|-2.45|STANDARD_ERROR_OF_MEAN|3.77|||TWO_SIDED|95.0|-10.26|5.37|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, 16-20 hours||5.37|-10.26|
72530698|NCT03091920|144590855|OTHER|No statistical testing was performed.|Least squares mean difference|-0.75|STANDARD_ERROR_OF_MEAN|2.83|||TWO_SIDED|95.0|-6.62|5.13|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, 20-24 hours||5.13|-6.62|
72530699|NCT03091920|144590855|OTHER|No statistical testing was performed.|Least squares mean difference|-1.13|STANDARD_ERROR_OF_MEAN|2.75|||TWO_SIDED|95.0|-6.83|4.58|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, 20-24 hours||4.58|-6.83|
72530700|NCT03091920|144590855|OTHER|No statistical testing was performed.|Least squares mean difference|-5.13|STANDARD_ERROR_OF_MEAN|2.7|||TWO_SIDED|95.0|-10.72|0.47|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, 0-4 hours||0.47|-10.72|
72530701|NCT03091920|144590855|OTHER|No statistical testing was performed.|Least squares mean difference|-3.64|STANDARD_ERROR_OF_MEAN|2.72|||TWO_SIDED|95.0|-9.29|2.01|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, 0-4 hours||2.01|-9.29|
72530702|NCT03091920|144590855|OTHER|No statistical testing was performed.|Least squares mean difference|-3.92|STANDARD_ERROR_OF_MEAN|3.52|||TWO_SIDED|95.0|-11.22|3.38|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, 4-8 hours||3.38|-11.22|
72530703|NCT03091920|144590855|OTHER|No statistical testing was performed.|Least squares mean difference|-2.46|STANDARD_ERROR_OF_MEAN|3.42|||TWO_SIDED|95.0|-9.54|4.63|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, 4-8 hours||4.63|-9.54|
72530704|NCT03091920|144590855|OTHER|No statistical testing was performed.|Least squares mean difference|-4.75|STANDARD_ERROR_OF_MEAN|2.96|||TWO_SIDED|95.0|-10.9|1.39|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, 8-12 hours||1.39|-10.90|
72530705|NCT03091920|144590855|OTHER|No statistical testing was performed.|Least squares mean difference|-1.25|STANDARD_ERROR_OF_MEAN|2.94|||TWO_SIDED|95.0|-7.35|4.85|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, 8-12 hours||4.85|-7.35|
72530706|NCT03091920|144590855|OTHER|No statistical testing was performed.|Least squares mean difference|-2.11|STANDARD_ERROR_OF_MEAN|3.11|||TWO_SIDED|95.0|-8.57|4.35|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, 12-16 hours||4.35|-8.57|
72530707|NCT03091920|144590855|OTHER|No statistical testing was performed.|Least squares mean difference|0.05|STANDARD_ERROR_OF_MEAN|3.02|||TWO_SIDED|95.0|-6.21|6.31|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, 12-16 hours||6.31|-6.21|
72530708|NCT03091920|144590855|OTHER|No statistical testing was performed.|Least squares mean difference|-6.66|STANDARD_ERROR_OF_MEAN|3.65|||TWO_SIDED|95.0|-14.22|0.9|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, 16-20 hours||0.90|-14.22|
72530709|NCT03091920|144590855|OTHER|No statistical testing was performed.|Least squares mean difference|-6.38|STANDARD_ERROR_OF_MEAN|3.68|||TWO_SIDED|95.0|-14.01|1.25|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, 16-20 hours||1.25|-14.01|
72530710|NCT03091920|144590855|OTHER|No statistical testing was performed.|Least squares mean difference|-2.29|STANDARD_ERROR_OF_MEAN|3.38|||TWO_SIDED|95.0|-9.3|4.71|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, 20-24 hours||4.71|-9.30|
72530711|NCT03091920|144590855|OTHER|No statistical testing was performed.|Least squares mean difference|-0.17|STANDARD_ERROR_OF_MEAN|3.28|||TWO_SIDED|95.0|-6.97|6.64|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, 20-24 hours||6.64|-6.97|
72530712|NCT03091920|144590855|OTHER|No statistical testing was performed.|Least squares mean difference|-7.74|STANDARD_ERROR_OF_MEAN|3.51|||TWO_SIDED|95.0|-15.03|-0.44|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14, 0-4 hours||-0.44|-15.03|
72530713|NCT03091920|144590855|OTHER|No statistical testing was performed.|Least squares mean difference|-3.86|STANDARD_ERROR_OF_MEAN|3.37|||TWO_SIDED|95.0|-10.88|3.16|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14, 0-4 hours||3.16|-10.88|
72530714|NCT03091920|144590855|OTHER|No statistical testing was performed.|Least squares mean difference|-9.53|STANDARD_ERROR_OF_MEAN|3.16|||TWO_SIDED|95.0|-16.1|-2.95|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14, 4-8||-2.95|-16.10|
72530715|NCT03091920|144590855|OTHER|No statistical testing was performed.|Least squares mean difference|-5.66|STANDARD_ERROR_OF_MEAN|2.96|||TWO_SIDED|95.0|-11.82|0.5|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14, 4-8 hours||0.50|-11.82|
72530716|NCT03091920|144590855|OTHER|No statistical testing was performed.|Least squares mean difference|-8.62|STANDARD_ERROR_OF_MEAN|4.4|||TWO_SIDED|95.0|-17.77|0.54|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14, 8-12 hours||0.54|-17.77|
72530717|NCT03091920|144590855|OTHER|No statistical testing was performed.|Least squares mean difference|-6.05|STANDARD_ERROR_OF_MEAN|4.2|||TWO_SIDED|95.0|-14.79|2.69|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14, 8-12 hours||2.69|-14.79|
72530718|NCT03091920|144590855|OTHER|No statistical testing was performed.|Least squares mean difference|-1.36|STANDARD_ERROR_OF_MEAN|4.4|||TWO_SIDED|95.0|-10.51|7.79|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14, 12-16 hours||7.79|-10.51|
72530719|NCT03091920|144590855|OTHER|No statistical testing was performed.|Least squares mean difference|-4.95|STANDARD_ERROR_OF_MEAN|4.11|||TWO_SIDED|95.0|-13.5|3.6|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14, 12-16 hours||3.60|-13.50|
72572011|NCT02912650|144671810|SUPERIORITY_OR_OTHER||LS Mean Difference|8.89|||<|0.001|TWO_SIDED|95.0|7.08|10.71|||ANOVA|||0-8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||10.71|7.08|<0.001
72407973|NCT04847674|144324259|OTHER||LS mean difference|-0.2||||0.3769|TWO_SIDED|95.0|-0.68|0.26|||Mixed Models Analysis||Change from baseline in AQLQT at Week 16: TEV-53275 Dose A versus Placebo|Analysis was performed using an MMRM with treatment group, week, randomization factors, and treatment group by week interaction as fixed effects, and baseline AQLQ as a covariate.||0.26|-0.68|0.3769
72407974|NCT04847674|144324259|OTHER||LS mean difference|-0.2||||0.4595|TWO_SIDED|95.0|-0.64|0.29|||Mixed Models Analysis||Change from baseline in AQLQT at Week 16: TEV-53275 Dose B versus Placebo|Analysis was performed using an MMRM with treatment group, week, randomization factors, and treatment group by week interaction as fixed effects, and baseline AQLQ as a covariate.||0.29|-0.64|0.4595
72530720|NCT03091920|144590855|OTHER|No statistical testing was performed.|Least squares mean difference|-3.43|STANDARD_ERROR_OF_MEAN|3.55|||TWO_SIDED|95.0|-10.81|3.96|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14, 16-20 hours||3.96|-10.81|
72530721|NCT03091920|144590855|OTHER|No statistical testing was performed.|Least squares mean difference|-5.38|STANDARD_ERROR_OF_MEAN|3.49|||TWO_SIDED|95.0|-12.64|1.89|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14, 16-20 hours||1.89|-12.64|
72530722|NCT03091920|144590855|OTHER|No statistical testing was performed.|Least squares mean difference|-0.08|STANDARD_ERROR_OF_MEAN|3.59|||TWO_SIDED|95.0|-7.55|7.39|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14, 20-24 hours||7.39|-7.55|
72530723|NCT03091920|144590855|OTHER|No statistical testing was performed.|Least squares mean difference|-1.89|STANDARD_ERROR_OF_MEAN|3.37|||TWO_SIDED|95.0|-8.89|5.12|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14, 20-24 hours||5.12|-8.89|
72572012|NCT02912650|144671810|SUPERIORITY_OR_OTHER||LS Mean Difference|2.0||||0.002|TWO_SIDED|95.0|0.73|3.26|||ANOVA|||0-8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||3.26|0.73|0.002
72572013|NCT02912650|144671810|SUPERIORITY_OR_OTHER||LS Mean Difference|4.48|||<|0.001|TWO_SIDED|95.0|3.2|5.77|||ANOVA|||0-8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||5.77|3.20|<0.001
72530724|NCT03091920|144590856|OTHER|No statistical testing was performed.|Least squares mean difference|-0.79|STANDARD_ERROR_OF_MEAN|1.63|||TWO_SIDED|95.0|-4.17|2.59|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1||2.59|-4.17|
72530725|NCT03091920|144590856|OTHER|No statistical testing was performed.|Least squares mean difference|-1.09|STANDARD_ERROR_OF_MEAN|1.63|||TWO_SIDED|95.0|-4.47|2.29|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1||2.29|-4.47|
72572014|NCT02912650|144671810|SUPERIORITY_OR_OTHER||LS Mean Difference|6.9|||<|0.001|TWO_SIDED|95.0|5.08|8.71|||ANOVA|||0-8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||8.71|5.08|<0.001
72530726|NCT03091920|144590856|OTHER|No statistical testing was performed.|Least squares mean difference|-0.94|STANDARD_ERROR_OF_MEAN|1.48|||TWO_SIDED|95.0|-4.02|2.14|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. Standard Error of the Mean=Standard Error of the LS Mean Difference.|Day 1||2.14|-4.02|
72530727|NCT03091920|144590856|OTHER|No statistical testing was performed.|Least squares mean difference|-2.67|STANDARD_ERROR_OF_MEAN|1.89|||TWO_SIDED|95.0|-6.6|1.26|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7||1.26|-6.60|
72530728|NCT03091920|144590856|OTHER|No statistical testing was performed.|Least squares mean difference|-1.84|STANDARD_ERROR_OF_MEAN|1.9|||TWO_SIDED|95.0|-5.77|2.1|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7||2.10|-5.77|
72530729|NCT03091920|144590856|OTHER|No statistical testing was performed.|Least squares mean difference|-2.25|STANDARD_ERROR_OF_MEAN|1.72|||TWO_SIDED|95.0|-5.83|1.32|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. Standard Error of the Mean=Standard Error of the LS Mean Difference.|Day 7||1.32|-5.83|
72530730|NCT03091920|144590856|OTHER|No statistical testing was performed.|Least squares mean difference|-3.97|STANDARD_ERROR_OF_MEAN|2.66|||TWO_SIDED|95.0|-9.5|1.56|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14||1.56|-9.50|
72530731|NCT03091920|144590856|OTHER|No statistical testing was performed.|Least squares mean difference|-4.17|STANDARD_ERROR_OF_MEAN|2.57|||TWO_SIDED|95.0|-9.52|1.18|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14||1.18|-9.52|
72530732|NCT03091920|144590856|OTHER|No statistical testing was performed.|Least squares mean difference|-4.07|STANDARD_ERROR_OF_MEAN|2.38|||TWO_SIDED|95.0|-9.01|0.87|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. Standard Error of the Mean=Standard Error of the LS Mean Difference.|Day 14||0.87|-9.01|
72530733|NCT03091920|144590857|OTHER|No statistical testing was performed.|Least squares mean difference|-3.4|STANDARD_ERROR_OF_MEAN|2.22|||TWO_SIDED|95.0|-8.01|1.21|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1||1.21|-8.01|
72530734|NCT03091920|144590857|OTHER|No statistical testing was performed.|Least squares mean difference|-3.6|STANDARD_ERROR_OF_MEAN|2.23|||TWO_SIDED|95.0|-8.21|1.02|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1||1.02|-8.21|
72530735|NCT03091920|144590857|OTHER|No statistical testing was performed.|Least squares mean difference|-3.3|STANDARD_ERROR_OF_MEAN|2.04|||TWO_SIDED|95.0|-7.53|0.92|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7||0.92|-7.53|
72530736|NCT03091920|144590857|OTHER|No statistical testing was performed.|Least squares mean difference|-2.01|STANDARD_ERROR_OF_MEAN|2.04|||TWO_SIDED|95.0|-6.24|2.23|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7||2.23|-6.24|
72572015|NCT02912650|144671810|SUPERIORITY_OR_OTHER||LS Mean Difference|4.41|||<|0.001|TWO_SIDED|95.0|2.58|6.24|||ANOVA|||0-8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||6.24|2.58|<0.001
72530737|NCT03091920|144590857|OTHER|No statistical testing was performed.|Least squares mean difference|-7.29|STANDARD_ERROR_OF_MEAN|2.65|||TWO_SIDED|95.0|-12.8|-1.79|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14||-1.79|-12.80|
72530738|NCT03091920|144590857|OTHER|No statistical testing was performed.|Least squares mean difference|-5.1|STANDARD_ERROR_OF_MEAN|2.56|||TWO_SIDED|95.0|-10.43|0.23|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14||0.23|-10.43|
72530739|NCT03091920|144590858|OTHER|No statistical testing was performed.|Least squares mean difference|0.99|STANDARD_ERROR_OF_MEAN|1.91|||TWO_SIDED|95.0|-2.97|4.95|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1||4.95|-2.97|
72530740|NCT03091920|144590858|OTHER|No statistical testing was performed.|Least squares mean difference|0.55|STANDARD_ERROR_OF_MEAN|1.91|||TWO_SIDED|95.0|-3.41|4.52|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1||4.52|-3.41|
72530741|NCT03091920|144590858|OTHER|No statistical testing was performed.|Least squares mean difference|-2.54|STANDARD_ERROR_OF_MEAN|2.46|||TWO_SIDED|95.0|-7.63|2.56|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7||2.56|-7.63|
72530742|NCT03091920|144590858|OTHER|No statistical testing was performed.|Least squares mean difference|-2.26|STANDARD_ERROR_OF_MEAN|2.46|||TWO_SIDED|95.0|-7.36|2.85|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7||2.85|-7.36|
72530743|NCT03091920|144590858|OTHER|No statistical testing was performed.|Least squares mean difference|-1.03|STANDARD_ERROR_OF_MEAN|3.13|||TWO_SIDED|95.0|-7.55|5.49|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14||5.49|-7.55|
72572016|NCT02912650|144671810|SUPERIORITY_OR_OTHER||LS Mean Difference|2.49|||<|0.001|TWO_SIDED|95.0|1.21|3.77|||ANOVA|||0-8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||3.77|1.21|<0.001
72572017|NCT02912650|144671810|SUPERIORITY_OR_OTHER||LS Mean Difference|10.42|||<|0.001|TWO_SIDED|95.0|7.76|13.08|||ANOVA|||0-12 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||13.08|7.76|<0.001
72572018|NCT02912650|144671810|SUPERIORITY_OR_OTHER||LS Mean Difference|2.14||||0.024|TWO_SIDED|95.0|0.28|4.0|||ANOVA|||0-12 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||4.00|0.28|0.024
72572019|NCT02912650|144671810|SUPERIORITY_OR_OTHER||LS Mean Difference|5.24|||<|0.001|TWO_SIDED|95.0|3.35|7.12|||ANOVA|||0-12 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||7.12|3.35|<0.001
72530744|NCT03091920|144590858|OTHER|No statistical testing was performed.|Least squares mean difference|-3.68|STANDARD_ERROR_OF_MEAN|3.04|||TWO_SIDED|95.0|-10.0|2.65|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14||2.65|-10.00|
72530745|NCT03091920|144590859|OTHER|No statistical testing was performed.|Least squares mean difference|-2.58|STANDARD_ERROR_OF_MEAN|2.49|||TWO_SIDED|95.0|-7.76|2.59|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, 0-4 hours||2.59|-7.76|
72530746|NCT03091920|144590859|OTHER|No statistical testing was performed.|Least squares mean difference|-4.06|STANDARD_ERROR_OF_MEAN|2.53|||TWO_SIDED|95.0|-9.32|1.19|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, 0-4 hours||1.19|-9.32|
72530747|NCT03091920|144590859|OTHER|No statistical testing was performed.|Least squares mean difference|-3.86|STANDARD_ERROR_OF_MEAN|2.73|||TWO_SIDED|95.0|-9.51|1.8|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, 4-8 hours||1.80|-9.51|
72530748|NCT03091920|144590859|OTHER|No statistical testing was performed.|Least squares mean difference|-4.73|STANDARD_ERROR_OF_MEAN|2.73|||TWO_SIDED|95.0|-10.4|0.93|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, 4-8 hours||0.93|-10.40|
72530749|NCT03091920|144590859|OTHER|No statistical testing was performed.|Least squares mean difference|-5.1|STANDARD_ERROR_OF_MEAN|3.36|||TWO_SIDED|95.0|-12.06|1.86|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, 8-12 hours||1.86|-12.06|
72530750|NCT03091920|144590859|OTHER|No statistical testing was performed.|Least squares mean difference|-2.96|STANDARD_ERROR_OF_MEAN|3.33|||TWO_SIDED|95.0|-9.87|3.96|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, 8-12 hours||3.96|-9.87|
72530751|NCT03091920|144590859|OTHER|No statistical testing was performed.|Least squares mean difference|0.87|STANDARD_ERROR_OF_MEAN|2.69|||TWO_SIDED|95.0|-4.7|6.45|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, 12-16 hours||6.45|-4.70|
72530752|NCT03091920|144590859|OTHER|No statistical testing was performed.|Least squares mean difference|0.55|STANDARD_ERROR_OF_MEAN|2.63|||TWO_SIDED|95.0|-4.9|6.01|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, 12-16 hours||6.01|-4.90|
72530753|NCT03091920|144590859|OTHER|No statistical testing was performed.|Least squares mean difference|-0.56|STANDARD_ERROR_OF_MEAN|3.21|||TWO_SIDED|95.0|-7.22|6.1|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, 16-20 hours||6.10|-7.22|
72530754|NCT03091920|144590859|OTHER|No statistical testing was performed.|Least squares mean difference|-0.47|STANDARD_ERROR_OF_MEAN|3.28|||TWO_SIDED|95.0|-7.27|6.34|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, 16-20 hours||6.34|-7.27|
72530755|NCT03091920|144590859|OTHER|No statistical testing was performed.|Least squares mean difference|1.72|STANDARD_ERROR_OF_MEAN|2.4|||TWO_SIDED|95.0|-3.26|6.69|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, 20-24 hours||6.69|-3.26|
72530756|NCT03091920|144590859|OTHER|No statistical testing was performed.|Least squares mean difference|0.25|STANDARD_ERROR_OF_MEAN|2.38|||TWO_SIDED|95.0|-4.69|5.2|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, 20-24 hours||5.20|-4.69|
72530757|NCT03091920|144590859|OTHER|No statistical testing was performed.|Least squares mean difference|-4.43|STANDARD_ERROR_OF_MEAN|1.96|||TWO_SIDED|95.0|-8.5|-0.36|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, 0-4 hours||-0.36|-8.50|
72530758|NCT03091920|144590859|OTHER|No statistical testing was performed.|Least squares mean difference|-4.17|STANDARD_ERROR_OF_MEAN|1.99|||TWO_SIDED|95.0|-8.3|-0.03|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, 0-4 hours||-0.03|-8.30|
72530759|NCT03091920|144590859|OTHER|No statistical testing was performed.|Least squares mean difference|-3.39|STANDARD_ERROR_OF_MEAN|3.1|||TWO_SIDED|95.0|-9.82|3.04|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, 4-8 hours||3.04|-9.82|
72530760|NCT03091920|144590859|OTHER|No statistical testing was performed.|Least squares mean difference|-1.06|STANDARD_ERROR_OF_MEAN|3.11|||TWO_SIDED|95.0|-7.51|5.38|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, 4-8 hours||5.38|-7.51|
72530761|NCT03091920|144590859|OTHER|No statistical testing was performed.|Least squares mean difference|-2.82|STANDARD_ERROR_OF_MEAN|2.56|||TWO_SIDED|95.0|-8.12|2.48|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, 8-12 hours||2.48|-8.12|
72530762|NCT03091920|144590859|OTHER|No statistical testing was performed.|Least squares mean difference|-1.36|STANDARD_ERROR_OF_MEAN|2.54|||TWO_SIDED|95.0|-6.63|3.91|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, 8-12 hours||3.91|-6.63|
72530763|NCT03091920|144590859|OTHER|No statistical testing was performed.|Least squares mean difference|-1.19|STANDARD_ERROR_OF_MEAN|2.97|||TWO_SIDED|95.0|-7.35|4.97|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, 12-16 hours||4.97|-7.35|
72530764|NCT03091920|144590859|OTHER|No statistical testing was performed.|Least squares mean difference|-1.26|STANDARD_ERROR_OF_MEAN|2.91|||TWO_SIDED|95.0|-7.3|4.77|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, 12-16 hours||4.77|-7.30|
72530765|NCT03091920|144590859|OTHER|No statistical testing was performed.|Least squares mean difference|-5.86|STANDARD_ERROR_OF_MEAN|3.29|||TWO_SIDED|95.0|-12.68|0.95|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, 16-20 hours||0.95|-12.68|
72530766|NCT03091920|144590859|OTHER|No statistical testing was performed.|Least squares mean difference|-6.2|STANDARD_ERROR_OF_MEAN|3.36|||TWO_SIDED|95.0|-13.16|0.76|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, 16-20 hours||0.76|-13.16|
72530767|NCT03091920|144590859|OTHER|No statistical testing was performed.|Least squares mean difference|-1.61|STANDARD_ERROR_OF_MEAN|3.02|||TWO_SIDED|95.0|-7.87|4.65|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, 20-24 hours||4.65|-7.87|
72530768|NCT03091920|144590859|OTHER|No statistical testing was performed.|Least squares mean difference|-0.63|STANDARD_ERROR_OF_MEAN|3.0|||TWO_SIDED|95.0|-6.85|5.59|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, 20-24 hours||5.59|-6.85|
72530769|NCT03091920|144590859|OTHER|No statistical testing was performed.|Least squares mean difference|-6.91|STANDARD_ERROR_OF_MEAN|2.8|||TWO_SIDED|95.0|-12.74|-1.08|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14, 0-4 hours||-1.08|-12.74|
72530770|NCT03091920|144590859|OTHER|No statistical testing was performed.|Least squares mean difference|-4.04|STANDARD_ERROR_OF_MEAN|2.74|||TWO_SIDED|95.0|-9.73|1.66|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14, 0-4 hours||1.66|-9.73|
72530771|NCT03091920|144590859|OTHER|No statistical testing was performed.|Least squares mean difference|-8.25|STANDARD_ERROR_OF_MEAN|2.57|||TWO_SIDED|95.0|-13.59|-2.91|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14, 4-8 hours||-2.91|-13.59|
72530772|NCT03091920|144590859|OTHER|No statistical testing was performed.|Least squares mean difference|-5.56|STANDARD_ERROR_OF_MEAN|2.5|||TWO_SIDED|95.0|-10.76|-0.35|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14, 4-8 hours||-0.35|-10.76|
72530773|NCT03091920|144590859|OTHER|No statistical testing was performed.|Least squares mean difference|-7.07|STANDARD_ERROR_OF_MEAN|3.91|||TWO_SIDED|95.0|-15.2|1.05|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14, 8-12 hours||1.05|-15.20|
72530774|NCT03091920|144590859|OTHER|No statistical testing was performed.|Least squares mean difference|-5.85|STANDARD_ERROR_OF_MEAN|3.77|||TWO_SIDED|95.0|-13.68|1.98|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14, 8-12 hours||1.98|-13.68|
72530775|NCT03091920|144590859|OTHER|No statistical testing was performed.|Least squares mean difference|-1.4|STANDARD_ERROR_OF_MEAN|4.2|||TWO_SIDED|95.0|-10.14|7.33|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14, 12-16 hours||7.33|-10.14|
72530776|NCT03091920|144590859|OTHER|No statistical testing was performed.|Least squares mean difference|-5.16|STANDARD_ERROR_OF_MEAN|3.99|||TWO_SIDED|95.0|-13.46|3.14|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14, 12-16 hours||3.14|-13.46|
72530777|NCT03091920|144590859|OTHER|No statistical testing was performed.|Least squares mean difference|-2.37|STANDARD_ERROR_OF_MEAN|3.74|||TWO_SIDED|95.0|-10.14|5.4|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14, 16-20 hours||5.40|-10.14|
72572020|NCT02912650|144671810|SUPERIORITY_OR_OTHER||LS Mean Difference|8.28|||<|0.001|TWO_SIDED|95.0|5.62|10.93|||ANOVA|||0-12 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||10.93|5.62|<0.001
72625694|NCT00619866|144780995|SUPERIORITY||LS Mean Difference|-0.69|STANDARD_ERROR_OF_MEAN|0.48||0.1459|TWO_SIDED|95.0|-1.63|0.24|||Repeated Measures ANCOVA||Difference = Elagolix - Placebo|Analysis at week 8. Change from baseline in in monthly peak values of the NRS for overall endometriosis-associated pelvic pain was analyzed by a repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for subject, and the baseline-by-time interaction, and the baseline value as a covariate.||0.24|-1.63|0.1459
72530778|NCT03091920|144590859|OTHER|No statistical testing was performed.|Least squares mean difference|-4.51|STANDARD_ERROR_OF_MEAN|3.72|||TWO_SIDED|95.0|-12.25|3.23|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14, 16-20 hours||3.23|-12.25|
72530779|NCT03091920|144590859|OTHER|No statistical testing was performed.|Least squares mean difference|-0.44|STANDARD_ERROR_OF_MEAN|3.44|||TWO_SIDED|95.0|-7.6|6.72|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14, 20-24 hours||6.72|-7.60|
72572021|NCT02912650|144671810|SUPERIORITY_OR_OTHER||LS Mean Difference|5.18|||<|0.001|TWO_SIDED|95.0|2.51|7.86|||ANOVA|||0-12 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||7.86|2.51|<0.001
72572022|NCT02912650|144671810|SUPERIORITY_OR_OTHER||LS Mean Difference|3.1||||0.001|TWO_SIDED|95.0|1.22|4.97|||ANOVA|||0-12 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||4.97|1.22|0.001
72530780|NCT03091920|144590859|OTHER|No statistical testing was performed.|Least squares mean difference|-1.98|STANDARD_ERROR_OF_MEAN|3.32|||TWO_SIDED|95.0|-8.88|4.92|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14, 20-24 hours||4.92|-8.88|
72530781|NCT03091920|144590860|OTHER|No statistical testing was performed.|Least squares mean difference|3.19|STANDARD_ERROR_OF_MEAN|1.59|||TWO_SIDED|95.0|-0.1|6.48|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1||6.48|-0.10|
72572023|NCT02912650|144671810|SUPERIORITY_OR_OTHER||LS Mean Difference|2.77|||<|0.001|TWO_SIDED|95.0|1.95|3.59|||ANOVA|||6-8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||3.59|1.95|<0.001
72572024|NCT02912650|144671810|SUPERIORITY_OR_OTHER||LS Mean Difference|0.66||||0.023|TWO_SIDED|95.0|0.09|1.24|||ANOVA|||6-8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.24|0.09|0.023
72530782|NCT03091920|144590860|OTHER|No statistical testing was performed.|Least squares mean difference|3.53|STANDARD_ERROR_OF_MEAN|1.58|||TWO_SIDED|95.0|0.25|6.82|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1||6.82|0.25|
72530783|NCT03091920|144590860|OTHER|No statistical testing was performed.|Least squares mean difference|3.36|STANDARD_ERROR_OF_MEAN|1.43|||TWO_SIDED|95.0|0.4|6.32|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. Standard Error of the Mean=Standard Error of the LS Mean Difference.|Day 1||6.32|0.40|
72530784|NCT03091920|144590860|OTHER|No statistical testing was performed.|Least squares mean difference|4.59|STANDARD_ERROR_OF_MEAN|1.76|||TWO_SIDED|95.0|0.95|8.23|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7||8.23|0.95|
72530785|NCT03091920|144590860|OTHER|No statistical testing was performed.|Least squares mean difference|4.49|STANDARD_ERROR_OF_MEAN|1.75|||TWO_SIDED|95.0|0.86|8.12|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7||8.12|0.86|
72530786|NCT03091920|144590860|OTHER|No statistical testing was performed.|Least squares mean difference|4.54|STANDARD_ERROR_OF_MEAN|1.58|||TWO_SIDED|95.0|1.27|7.81|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. Standard Error of the Mean=Standard Error of the LS Mean Difference.|Day 7||7.81|1.27|
72530787|NCT03091920|144590860|OTHER|No statistical testing was performed.|Least squares mean difference|2.58|STANDARD_ERROR_OF_MEAN|1.94|||TWO_SIDED|95.0|-1.45|6.61|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14||6.61|-1.45|
72530788|NCT03091920|144590860|OTHER|No statistical testing was performed.|Least squares mean difference|3.17|STANDARD_ERROR_OF_MEAN|1.9|||TWO_SIDED|95.0|-0.78|7.11|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14||7.11|-0.78|
72530789|NCT03091920|144590860|OTHER|No statistical testing was performed.|Least squares mean difference|2.87|STANDARD_ERROR_OF_MEAN|1.72|||TWO_SIDED|95.0|-0.71|6.45|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. Standard Error of the Mean=Standard Error of the LS Mean Difference.|Day 14||6.45|-0.71|
72530790|NCT03091920|144590861|OTHER|No statistical testing was performed.|Least squares mean difference|2.17|STANDARD_ERROR_OF_MEAN|2.32|||TWO_SIDED|95.0|-2.65|6.99|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1||6.99|-2.65|
72530791|NCT03091920|144590861|OTHER|No statistical testing was performed.|Least squares mean difference|4.09|STANDARD_ERROR_OF_MEAN|2.33|||TWO_SIDED|95.0|-0.73|8.91|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1||8.91|-0.73|
72530792|NCT03091920|144590861|OTHER|No statistical testing was performed.|Least squares mean difference|4.56|STANDARD_ERROR_OF_MEAN|1.91|||TWO_SIDED|95.0|0.6|8.51|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7||8.51|0.60|
72530793|NCT03091920|144590861|OTHER|No statistical testing was performed.|Least squares mean difference|4.02|STANDARD_ERROR_OF_MEAN|1.91|||TWO_SIDED|95.0|0.07|7.98|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7||7.98|0.07|
72530794|NCT03091920|144590861|OTHER|No statistical testing was performed.|Least squares mean difference|3.12|STANDARD_ERROR_OF_MEAN|2.05|||TWO_SIDED|95.0|-1.15|7.39|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14||7.39|-1.15|
72530795|NCT03091920|144590861|OTHER|No statistical testing was performed.|Least squares mean difference|3.74|STANDARD_ERROR_OF_MEAN|2.01|||TWO_SIDED|95.0|-0.44|7.92|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14||7.92|-0.44|
72530796|NCT03091920|144590862|OTHER|No statistical testing was performed.|Least squares mean difference|4.3|STANDARD_ERROR_OF_MEAN|1.54|||TWO_SIDED|95.0|1.1|7.49|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1||7.49|1.10|
72572025|NCT02912650|144671810|SUPERIORITY_OR_OTHER||LS Mean Difference|1.66|||<|0.001|TWO_SIDED|95.0|1.07|2.24|||ANOVA|||6-8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||2.24|1.07|<0.001
72572026|NCT02912650|144671810|SUPERIORITY_OR_OTHER||LS Mean Difference|2.11|||<|0.001|TWO_SIDED|95.0|1.29|2.92|||ANOVA|||6-8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||2.92|1.29|<0.001
72625695|NCT00619866|144780995|SUPERIORITY||LS Mean Difference|-1.16|STANDARD_ERROR_OF_MEAN|0.48||0.0163|TWO_SIDED|95.0|-2.1|-0.21|||Repeated Measures ANCOVA||Difference = Elagolix - Placebo|Analysis at week 8. Change from baseline in in monthly peak values of the NRS for overall endometriosis-associated pelvic pain was analyzed by a repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for subject, and the baseline-by-time interaction, and the baseline value as a covariate.||-0.21|-2.10|0.0163
72625696|NCT00619866|144780995|SUPERIORITY||LS Mean Difference|-1.15|STANDARD_ERROR_OF_MEAN|0.5||0.0207|TWO_SIDED|95.0|-2.13|-0.18|||Repeated Measures ANCOVA||Difference = Elagolix - Placebo|Analysis at week 12. Change from baseline in in monthly peak values of the NRS for overall endometriosis-associated pelvic pain was analyzed by a repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for subject, and the baseline-by-time interaction, and the baseline value as a covariate.||-0.18|-2.13|0.0207
72572027|NCT02912650|144671810|SUPERIORITY_OR_OTHER||LS Mean Difference|1.11||||0.008|TWO_SIDED|95.0|0.29|1.94|||ANOVA|||6-8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.94|0.29|0.008
72530797|NCT03091920|144590862|OTHER|No statistical testing was performed.|Least squares mean difference|2.94|STANDARD_ERROR_OF_MEAN|1.53|||TWO_SIDED|95.0|-0.23|6.1|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1||6.10|-0.23|
72530798|NCT03091920|144590862|OTHER|No statistical testing was performed.|Least squares mean difference|4.8|STANDARD_ERROR_OF_MEAN|2.07|||TWO_SIDED|95.0|0.5|9.11|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7||9.11|0.50|
72530799|NCT03091920|144590862|OTHER|No statistical testing was performed.|Least squares mean difference|5.1|STANDARD_ERROR_OF_MEAN|2.05|||TWO_SIDED|95.0|0.84|9.36|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7||9.36|0.84|
72530800|NCT03091920|144590862|OTHER|No statistical testing was performed.|Least squares mean difference|1.89|STANDARD_ERROR_OF_MEAN|2.32|||TWO_SIDED|95.0|-2.93|6.7|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14||6.70|-2.93|
72530801|NCT03091920|144590862|OTHER|No statistical testing was performed.|Least squares mean difference|2.55|STANDARD_ERROR_OF_MEAN|2.26|||TWO_SIDED|95.0|-2.15|7.25|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14||7.25|-2.15|
72530802|NCT03091920|144590863|OTHER|No statistical testing was performed.|Least squares mean difference|6.81|STANDARD_ERROR_OF_MEAN|2.61|||TWO_SIDED|95.0|1.4|12.22|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, 0-4 hours||12.22|1.40|
72530803|NCT03091920|144590863|OTHER|No statistical testing was performed.|Least squares mean difference|6.55|STANDARD_ERROR_OF_MEAN|2.62|||TWO_SIDED|95.0|1.12|11.99|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, 0-4 hours||11.99|1.12|
72530804|NCT03091920|144590863|OTHER|No statistical testing was performed.|Least squares mean difference|-0.95|STANDARD_ERROR_OF_MEAN|3.49|||TWO_SIDED|95.0|-8.18|6.28|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, 4-8 hours||6.28|-8.18|
72530805|NCT03091920|144590863|OTHER|No statistical testing was performed.|Least squares mean difference|1.85|STANDARD_ERROR_OF_MEAN|3.49|||TWO_SIDED|95.0|-5.39|9.09|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, 4-8 hours||9.09|-5.39|
72530806|NCT03091920|144590863|OTHER|No statistical testing was performed.|Least squares mean difference|-0.38|STANDARD_ERROR_OF_MEAN|2.7|||TWO_SIDED|95.0|-5.98|5.23|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, 8-12 hours||5.23|-5.98|
72530807|NCT03091920|144590863|OTHER|No statistical testing was performed.|Least squares mean difference|3.1|STANDARD_ERROR_OF_MEAN|2.7|||TWO_SIDED|95.0|-2.5|8.7|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, 8-12 hours||8.70|-2.50|
72530808|NCT03091920|144590863|OTHER|No statistical testing was performed.|Least squares mean difference|6.46|STANDARD_ERROR_OF_MEAN|2.14|||TWO_SIDED|95.0|2.02|10.89|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, 12-16 hours||10.89|2.02|
72530809|NCT03091920|144590863|OTHER|No statistical testing was performed.|Least squares mean difference|5.57|STANDARD_ERROR_OF_MEAN|2.11|||TWO_SIDED|95.0|1.19|9.95|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, 12-16 hours||9.95|1.19|
72530810|NCT03091920|144590863|OTHER|No statistical testing was performed.|Least squares mean difference|3.63|STANDARD_ERROR_OF_MEAN|1.59|||TWO_SIDED|95.0|0.34|6.91|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, 16-20 hours||6.91|0.34|
72530811|NCT03091920|144590863|OTHER|No statistical testing was performed.|Least squares mean difference|2.41|STANDARD_ERROR_OF_MEAN|1.57|||TWO_SIDED|95.0|-0.84|5.66|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, 16-20 hours||5.66|-0.84|
72530812|NCT03091920|144590863|OTHER|No statistical testing was performed.|Least squares mean difference|1.74|STANDARD_ERROR_OF_MEAN|2.23|||TWO_SIDED|95.0|-2.89|6.36|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, 20-24 hours||6.36|-2.89|
72530813|NCT03091920|144590863|OTHER|No statistical testing was performed.|Least squares mean difference|0.33|STANDARD_ERROR_OF_MEAN|2.25|||TWO_SIDED|95.0|-4.33|4.99|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, 20-24 hours||4.99|-4.33|
72530814|NCT03091920|144590863|OTHER|No statistical testing was performed.|Least squares mean difference|4.36|STANDARD_ERROR_OF_MEAN|2.66|||TWO_SIDED|95.0|-1.17|9.88|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, 0-4 hours||9.88|-1.17|
72530815|NCT03091920|144590863|OTHER|No statistical testing was performed.|Least squares mean difference|5.41|STANDARD_ERROR_OF_MEAN|2.68|||TWO_SIDED|95.0|-0.14|10.96|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, 0-4 hours||10.96|-0.14|
72530816|NCT03091920|144590863|OTHER|No statistical testing was performed.|Least squares mean difference|4.88|STANDARD_ERROR_OF_MEAN|2.18|||TWO_SIDED|95.0|0.36|9.4|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, 4-8 hours||9.40|0.36|
72530817|NCT03091920|144590863|OTHER|No statistical testing was performed.|Least squares mean difference|4.3|STANDARD_ERROR_OF_MEAN|2.18|||TWO_SIDED|95.0|-0.22|8.83|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, 4-8 hours||8.83|-0.22|
72530818|NCT03091920|144590863|OTHER|No statistical testing was performed.|Least squares mean difference|4.04|STANDARD_ERROR_OF_MEAN|2.26|||TWO_SIDED|95.0|-0.65|8.72|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, 8-12 hours||8.72|-0.65|
72530819|NCT03091920|144590863|OTHER|No statistical testing was performed.|Least squares mean difference|2.26|STANDARD_ERROR_OF_MEAN|2.26|||TWO_SIDED|95.0|-2.42|6.94|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, 8-12 hours||6.94|-2.42|
72530820|NCT03091920|144590863|OTHER|No statistical testing was performed.|Least squares mean difference|6.9|STANDARD_ERROR_OF_MEAN|2.41|||TWO_SIDED|95.0|1.91|11.89|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, 12-16 hours||11.89|1.91|
72530821|NCT03091920|144590863|OTHER|No statistical testing was performed.|Least squares mean difference|6.15|STANDARD_ERROR_OF_MEAN|2.38|||TWO_SIDED|95.0|1.22|11.08|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, 12-16 hours||11.08|1.22|
72530822|NCT03091920|144590863|OTHER|No statistical testing was performed.|Least squares mean difference|4.99|STANDARD_ERROR_OF_MEAN|2.38|||TWO_SIDED|95.0|0.05|9.93|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, 16-20 hours||9.93|0.05|
72530823|NCT03091920|144590863|OTHER|No statistical testing was performed.|Least squares mean difference|5.34|STANDARD_ERROR_OF_MEAN|2.36|||TWO_SIDED|95.0|0.45|10.22|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, 16-20 hours||10.22|0.45|
72530824|NCT03091920|144590863|OTHER|No statistical testing was performed.|Least squares mean difference|1.67|STANDARD_ERROR_OF_MEAN|2.33|||TWO_SIDED|95.0|-3.17|6.52|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, 20-24 hours||6.52|-3.17|
72530825|NCT03091920|144590863|OTHER|No statistical testing was performed.|Least squares mean difference|4.03|STANDARD_ERROR_OF_MEAN|2.36|||TWO_SIDED|95.0|-0.86|8.92|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, 20-24 hours||8.92|-0.86|
72530826|NCT03091920|144590863|OTHER|No statistical testing was performed.|Least squares mean difference|4.05|STANDARD_ERROR_OF_MEAN|2.51|||TWO_SIDED|95.0|-1.18|9.27|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14, 0-4 hours||9.27|-1.18|
72530827|NCT03091920|144590863|OTHER|No statistical testing was performed.|Least squares mean difference|3.76|STANDARD_ERROR_OF_MEAN|2.47|||TWO_SIDED|95.0|-1.38|8.9|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14, 0-4 hours||8.90|-1.38|
72530828|NCT03091920|144590863|OTHER|No statistical testing was performed.|Least squares mean difference|5.18|STANDARD_ERROR_OF_MEAN|3.31|||TWO_SIDED|95.0|-1.7|12.06|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14, 4-8 hours||12.06|-1.70|
72407975|NCT02702401|144324300|SUPERIORITY||Hazard Ratio (HR)|0.775||||0.0186|TWO_SIDED|95.0|0.609|0.987|||Log Rank|One-sided p-value stratified by geographic region, macrovascular invasion and alfa-fetoprotein level.|Cox regression model with Efron's method (treatment as covariate) stratified by geographic region, macrovascular invasion and alfa-fetoprotein level|||0.987|0.609|0.0186
72530829|NCT03091920|144590863|OTHER|No statistical testing was performed.|Least squares mean difference|5.61|STANDARD_ERROR_OF_MEAN|3.25|||TWO_SIDED|95.0|-1.14|12.37|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14, 4-8 hours||12.37|-1.14|
72530830|NCT03091920|144590863|OTHER|No statistical testing was performed.|Least squares mean difference|-0.21|STANDARD_ERROR_OF_MEAN|2.47|||TWO_SIDED|95.0|-5.35|4.92|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14, 8-12 hours||4.92|-5.35|
72530831|NCT03091920|144590863|OTHER|No statistical testing was performed.|Least squares mean difference|1.61|STANDARD_ERROR_OF_MEAN|2.42|||TWO_SIDED|95.0|-3.42|6.65|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14, 8-12 hours||6.65|-3.42|
72530832|NCT03091920|144590863|OTHER|No statistical testing was performed.|Least squares mean difference|5.08|STANDARD_ERROR_OF_MEAN|3.02|||TWO_SIDED|95.0|-1.19|11.36|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14, 12-16 hours||11.36|-1.19|
72530833|NCT03091920|144590863|OTHER|No statistical testing was performed.|Least squares mean difference|5.3|STANDARD_ERROR_OF_MEAN|2.94|||TWO_SIDED|95.0|-0.83|11.42|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14, 12-16 hours||11.42|-0.83|
72530834|NCT03091920|144590863|OTHER|No statistical testing was performed.|Least squares mean difference|1.3|STANDARD_ERROR_OF_MEAN|2.56|||TWO_SIDED|95.0|-4.02|6.63|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14, 16-20 hours||6.63|-4.02|
72530835|NCT03091920|144590863|OTHER|No statistical testing was performed.|Least squares mean difference|2.93|STANDARD_ERROR_OF_MEAN|2.5|||TWO_SIDED|95.0|-2.26|8.12|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14, 16-20 hours||8.12|-2.26|
72530836|NCT03091920|144590863|OTHER|No statistical testing was performed.|Least squares mean difference|-1.34|STANDARD_ERROR_OF_MEAN|2.98|||TWO_SIDED|95.0|-7.52|4.85|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14, 20-24 hours||4.85|-7.52|
72530837|NCT03091920|144590863|OTHER|No statistical testing was performed.|Least squares mean difference|-1.14|STANDARD_ERROR_OF_MEAN|2.94|||TWO_SIDED|95.0|-7.25|4.98|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14, 20-24 hours||4.98|-7.25|
72530838|NCT03091920|144590864|OTHER|No statistical testing was performed.|Least squares mean difference|-0.288|STANDARD_ERROR_OF_MEAN|0.274|||TWO_SIDED|95.0|-0.857|0.282|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. Standard Error of the Mean=Standard Error of the LS Mean Difference.|||0.282|-0.857|
72530839|NCT03091920|144590864|OTHER|No statistical testing was performed.|Least squares mean difference|-0.105|STANDARD_ERROR_OF_MEAN|0.29|||TWO_SIDED|95.0|-0.708|0.498|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. Standard Error of the Mean=Standard Error of the LS Mean Difference.|||0.498|-0.708|
72530840|NCT03091920|144590864|OTHER|No statistical testing was performed.|Least squares mean difference|-0.196|STANDARD_ERROR_OF_MEAN|0.255|||TWO_SIDED|95.0|-0.727|0.335|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. Standard Error of the Mean=Standard Error of the LS Mean Difference.|||0.335|-0.727|
72530841|NCT03091920|144590869|OTHER|No statistical testing was performed.|Least squares mean difference|-23.188|STANDARD_ERROR_OF_MEAN|27.97|||TWO_SIDED|95.0|-84.13|37.753|||||Least Squares mean difference and associated 95% confidence interval (CI) is from an analysis of covariance (ANCOVA) model with treatment as fixed effect and baseline as covariate. Standard Error of the Mean=Standard Error of the LS Mean Difference.|Day 8||37.753|-84.130|
72530842|NCT03091920|144590869|OTHER|No statistical testing was performed.|Least squares mean difference|-14.033|STANDARD_ERROR_OF_MEAN|26.092|||TWO_SIDED|95.0|-70.883|42.817|||||Least Squares mean difference and associated 95% confidence interval (CI) is from an analysis of covariance (ANCOVA) model with treatment as fixed effect and baseline as covariate. Standard Error of the Mean=Standard Error of the LS Mean Difference.|Day 8||42.817|-70.883|
72530843|NCT03091920|144590869|OTHER|No statistical testing was performed.|Least squares mean difference|-18.611|STANDARD_ERROR_OF_MEAN|24.138|||TWO_SIDED|95.0|-71.204|33.982|||||Least Squares mean difference and associated 95% confidence interval (CI) is from an analysis of covariance (ANCOVA) model with treatment as fixed effect and baseline as covariate. Standard Error of the Mean=Standard Error of the LS Mean Difference.|Day 8||33.982|-71.204|
72530844|NCT03091920|144590869|OTHER|No statistical testing was performed.|Least squares mean difference|-25.389|STANDARD_ERROR_OF_MEAN|16.885|||TWO_SIDED|95.0|-62.551|11.774|||||Least Squares mean difference and associated 95% confidence interval (CI) is from an analysis of covariance (ANCOVA) model with treatment as fixed effect and baseline as covariate. Standard Error of the Mean=Standard Error of the LS Mean Difference.|Day 15||11.774|-62.551|
72530845|NCT03091920|144590869|OTHER|No statistical testing was performed.|Least squares mean difference|-21.176|STANDARD_ERROR_OF_MEAN|16.221|||TWO_SIDED|95.0|-56.879|14.527|||||Least Squares mean difference and associated 95% confidence interval (CI) is from an analysis of covariance (ANCOVA) model with treatment as fixed effect and baseline as covariate. Standard Error of the Mean=Standard Error of the LS Mean Difference.|Day 15||14.527|-56.879|
72530846|NCT03091920|144590869|OTHER|No statistical testing was performed.|Least squares mean difference|-23.282|STANDARD_ERROR_OF_MEAN|14.691|||TWO_SIDED|95.0|-55.618|9.053|||||Least Squares mean difference and associated 95% confidence interval (CI) is from an analysis of covariance (ANCOVA) model with treatment as fixed effect and baseline as covariate. Standard Error of the Mean=Standard Error of the LS Mean Difference.|Day 15||9.053|-55.618|
72530847|NCT00453349|144590889|NON_INFERIORITY_OR_EQUIVALENCE|"The non-inferiority margin was set to 15% in the protocol. Sample size was estimated using the method as described in Farrington-Manning (STATISTICS IN MEDICINE, Vol. 9; Farrington CP, Manning G: Test statistics and sample size formulae for comparative binomial trials with null hypothesis of non-zero risk difference..., pg.1447-1454 \[1990\]). Estimation was performed to achieve 90% power, based on the equivalence delta of 15%, and a clinical success rate of 87% in the per protocol population"|Mean Difference (Final Values)|-3.2||||||95.0|-10.7|4.9|||||Mean difference denotes the difference of clinical cure rates in percent between the two treatment groups. A positive value indicates an advantage for the treatment group of moxifloxacin, a negative value an advantage for the comparator group.|Calculated were 95% confidence intervals for the difference in success rates between treatment groups (moxifloxacin minus comparator). Method as described in Koch et al. ('Categorical Data Analysis' in Statistical methodology in the pharmaceutical sciences / edited by D. A. Berry, p. 415 ff., Marcel Dekker, 1990)||4.9|-10.7|
72530848|NCT00453349|144590890|NON_INFERIORITY_OR_EQUIVALENCE|Sample size estimation was based on the primary efficacy variables.|Mean Difference (Final Values)|-1.9||||||95.0|-9.9|6.0|||||Mean difference denotes the difference of clinical cure rates in percent between the two treatment groups. A positive value indicates an advantage for the treatment group of moxifloxacin, a negative value an advantage for the comparator group.|Calculated were 95% confidence intervals for the difference in success rates between treatment groups (moxifloxacin minus comparator). Method as described in Koch et al. ('Categorical Data Analysis' in Statistical methodology in the pharmaceutical sciences / edited by D. A. Berry, p. 415 ff., Marcel Dekker, 1990)||6.0|-9.9|
72530849|NCT00453349|144590891|NON_INFERIORITY_OR_EQUIVALENCE|Sample size estimation was based on the primary efficacy variables.|Mean Difference (Final Values)|-3.2||||||95.0|-7.4|0.8|||||Mean difference denotes the difference of clinical improvement rates in percent between the two treatment groups. A positive value indicates an advantage for the treatment group of moxifloxacin, a negative value an advantage for the comparator group.|Calculated were 95% confidence intervals for the difference in success rates between treatment groups (moxifloxacin minus comparator). Method as described in Koch et al. ('Categorical Data Analysis' in Statistical methodology in the pharmaceutical sciences / edited by D. A. Berry, p. 415 ff., Marcel Dekker, 1990)||0.8|-7.4|
72530850|NCT00453349|144590892|NON_INFERIORITY_OR_EQUIVALENCE|Sample size estimation was based on the primary efficacy variables.|Mean Difference (Final Values)|-0.1||||||95.0|-8.1|7.5|||||Mean difference denotes the difference of clinical improvement rates in percent between the two treatment groups. A positive value indicates an advantage for the treatment group of moxifloxacin, a negative value an advantage for the comparator group.|Calculated were 95% confidence intervals for the difference in success rates between treatment groups (moxifloxacin minus comparator). Method as described in Koch et al. ('Categorical Data Analysis' in Statistical methodology in the pharmaceutical sciences / edited by D. A. Berry, p. 415 ff., Marcel Dekker, 1990)||7.5|-8.1|
72530851|NCT00453349|144590893|NON_INFERIORITY_OR_EQUIVALENCE|Sample size estimation was based on the primary efficacy variables.|Mean Difference (Final Values)|5.4||||||95.0|-12.7|20.3|||||Mean difference denotes the difference of eradication rates in percent between the two treatment groups. A positive value indicates an advantage for the treatment group of moxifloxacin, a negative value an advantage for the comparator group.|Calculated were 95% confidence intervals for the difference in success rates between treatment groups (moxifloxacin minus comparator). Method as described in Koch et al. ('Categorical Data Analysis' in Statistical methodology in the pharmaceutical sciences / edited by D. A. Berry, p. 415 ff., Marcel Dekker, 1990)||20.3|-12.7|
72572028|NCT02912650|144671810|SUPERIORITY_OR_OTHER||LS Mean Difference|0.99|||<|0.001|TWO_SIDED|95.0|0.41|1.57|||ANOVA|||6-8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.57|0.41|<0.001
72530852|NCT00453349|144590894|NON_INFERIORITY_OR_EQUIVALENCE|Sample size estimation was based on the primary efficacy variables.|Mean Difference (Final Values)|4.3||||||95.0|-19.4|17.6|||||Mean difference denotes the difference of eradication rates in percent between the two treatment groups. A positive value indicates an advantage for the treatment group of moxifloxacin, a negative value an advantage for the comparator group.|Calculated were 95% confidence intervals for the difference in success rates between treatment groups (moxifloxacin minus comparator). Method as described in Koch et al. ('Categorical Data Analysis' in Statistical methodology in the pharmaceutical sciences / edited by D. A. Berry, p. 415 ff., Marcel Dekker, 1990)||17.6|-19.4|
72530853|NCT00453349|144590895|NON_INFERIORITY_OR_EQUIVALENCE|Sample size estimation was based on the primary efficacy variables.|Mean Difference (Final Values)|-2.5||||||95.0|-8.6|4.9|||||Mean difference denotes the difference of clinical cure rates in percent between the two treatment groups. A positive value indicates an advantage for the treatment group of moxifloxacin, a negative value an advantage for the comparator group.|Calculated were 95% confidence intervals for the difference in success rates between treatment groups (moxifloxacin minus comparator). Method as described in Koch et al. ('Categorical Data Analysis' in Statistical methodology in the pharmaceutical sciences / edited by D. A. Berry, p. 415 ff., Marcel Dekker, 1990)||4.9|-8.6|
72530854|NCT00453349|144590896|NON_INFERIORITY_OR_EQUIVALENCE|Sample size estimation was based on the primary efficacy variables.|Mean Difference (Final Values)|-0.1||||||95.0|-8.1|7.5|||||Mean difference denotes the difference of clinical cure rates in percent between the two treatment groups. A positive value indicates an advantage for the treatment group of moxifloxacin, a negative value an advantage for the comparator group.|Calculated were 95% confidence intervals for the difference in success rates between treatment groups (moxifloxacin minus comparator). Method as described in Koch et al. ('Categorical Data Analysis' in Statistical methodology in the pharmaceutical sciences / edited by D. A. Berry, p. 415 ff., Marcel Dekker, 1990)||7.5|-8.1|
72530855|NCT00453349|144590897|NON_INFERIORITY_OR_EQUIVALENCE|Sample size estimation was based on the primary efficacy variables.|Mean Difference (Final Values)|-7.9||||||95.0|-24.9|15.9|||||Mean difference denotes the difference of eradication rates in percent between the two treatment groups. A positive value indicates an advantage for the treatment group of moxifloxacin, a negative value an advantage for the comparator group.|Calculated were 95% confidence intervals for the difference in success rates between treatment groups (moxifloxacin minus comparator). Method as described in Koch et al. ('Categorical Data Analysis' in Statistical methodology in the pharmaceutical sciences / edited by D. A. Berry, p. 415 ff., Marcel Dekker, 1990)||15.9|-24.9|
72530856|NCT00453349|144590898|NON_INFERIORITY_OR_EQUIVALENCE|Sample size estimation was based on the primary efficacy variables.|Mean Difference (Final Values)|3.7||||||95.0|-30.5|11.9|||||Mean difference denotes the difference of eradication rates in percent between the two treatment groups. A positive value indicates an advantage for the treatment group of moxifloxacin, a negative value an advantage for the comparator group.|Calculated were 95% confidence intervals for the difference in success rates between treatment groups (moxifloxacin minus comparator). Method as described in Koch et al. ('Categorical Data Analysis' in Statistical methodology in the pharmaceutical sciences / edited by D. A. Berry, p. 415 ff., Marcel Dekker, 1990)||11.9|-30.5|
72625697|NCT00619866|144780995|SUPERIORITY||LS Mean Difference|-1.44|STANDARD_ERROR_OF_MEAN|0.5||0.0038|TWO_SIDED|95.0|-2.42|-0.47|||Repeated Measures ANCOVA||Difference = Elagolix - Placebo|Analysis at week 12. Change from baseline in in monthly peak values of the NRS for overall endometriosis-associated pelvic pain was analyzed by a repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for subject, and the baseline-by-time interaction, and the baseline value as a covariate.||-0.47|-2.42|0.0038
72625698|NCT00619866|144780996|SUPERIORITY||LS Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.07||0.5744|TWO_SIDED|95.0|-0.18|0.1|||Repeated Measures ANCOVA||Difference = Elagolix - Placebo|Analysis at week 4. Change from baseline in non-menstrual pelvic pain score was analyzed by a repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for subject, and the baseline-by-time interaction, and the baseline value as a covariate.||0.10|-0.18|0.5744
72530857|NCT00784225|144590946|SUPERIORITY||Cox Proportional Hazard|0.75||||0.52|TWO_SIDED|95.0|0.32|1.79|||Regression, Cox|||Statistical analysis for number of participants with visually significant AMD in SEE sites during pill-taking for selenium||1.79|0.32|0.52
72530858|NCT00784225|144590946|SUPERIORITY||Cox Proportional Hazard|0.75||||0.51|TWO_SIDED|95.0|0.31|1.77|||Regression, Cox|||Statistical analysis for number of participants with visually significant AMD in SEE sites during pill-taking for vitamin E||1.77|0.31|0.51
72530859|NCT00784225|144590947|SUPERIORITY||Cox Proportional Hazard|0.91||||0.37|TWO_SIDED|95.0|0.75|1.11|||Regression, Cox|||||1.11|0.75|0.37
72530860|NCT00784225|144590947|SUPERIORITY||Cox Proportional Hazard|1.02||||0.81|TWO_SIDED|95.0|0.84|1.25|||Regression, Cox|||||1.25|0.84|0.81
72530861|NCT00784225|144590948|SUPERIORITY||Cox Proportional Hazard|2.5||||0.12|TWO_SIDED|95.0|0.79|7.98|||Regression, Cox|||Statistical analysis for number of participants with advanced AMD in SEE sites during pill-taking for selenium||7.98|0.79|0.12
72530862|NCT00784225|144590948|SUPERIORITY||Cox Proportional Hazard|0.99||||0.98|TWO_SIDED|95.0|0.35|2.82|||Regression, Cox|||Statistical analysis for number of participants with advanced AMD in SEE sites during pill-taking for vitamin E||2.82|0.35|0.98
72530863|NCT00784225|144590949|SUPERIORITY||Cox Proportional Hazard|0.84||||0.19|TWO_SIDED|95.0|0.64|1.09|||Regression, Cox|||||1.09|0.64|0.19
72530864|NCT00784225|144590949|SUPERIORITY||Cox Proportional Hazard|1.08||||0.58|TWO_SIDED|95.0|0.83|1.41|||Regression, Cox|||||1.41|0.83|0.58
72542617|NCT01042977|144615155|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.71|STANDARD_ERROR_OF_MEAN|0.7977||0.0007|TWO_SIDED|95.0|-4.28|-1.15||Significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure|ANCOVA|with treatment group and stratum as effects and baseline value as covariate|with stratum = age-by-insulin use-by-time from most recent qualifying CV event|H0: mean(treat) minus mean(placebo) = 0 versus the alternative HA: mean(treat) minus mean(placebo) =/= 0||-1.15|-4.28|0.0007
72530865|NCT00313716|144590950|SUPERIORITY_OR_OTHER|||||||0.01||||||"H0: Proportion of participants expected to have a favorable GOS outcome in the Epo2 group - in Placebo group is \>= 0.2.~H1: Proportion in Epo2 group - in Placebo group \< 0.2"|Futility analysis|||The primary analysis plan was a futility trial of the Epo 2 regimen arm. We hypothesized that 30% of subjects in the placebo group would have a favorable outcome at six months and there would be no interaction between the Epo and the transfusion threshold groups. Using a one-sided alpha of 0.15, a sample size of 62 subjects in the Epo 2 regimen group and 100 subjects in the placebo group provided 91% power to test the futility hypothesis.||||.01
72530866|NCT00313716|144590950|SUPERIORITY_OR_OTHER|||||||0.13||||||"H0: Proportion of participants expected to have a favorable GOS outcome in the Epo1 group - in Placebo group is \>= 0.2.~H1: Proportion in Epo1 group - in Placebo group \< 0.2"|Futility analysis|||The primary analysis plan was a futility trial of the Epo 1 regimen arm. We hypothesized that 30% of subjects in the placebo group would have a favorable outcome at six months and there would be no interaction between the Epo and the transfusion threshold groups.||||0.13
72530867|NCT00313716|144590950|SUPERIORITY_OR_OTHER|||||||0.34|||||||2-sample test of proportions|||We hypothesized that 40% of the patients in the TT7 group would have a favorable GOS score and that there would be no interaction between the Epo and TT groups. Assuming a 2-sided test with an alpha level of 0.05, we estimated that a sample size of 200 patients would provide 80% power to detect a 20% absolute increase in the GOS score for the TT10 group.||||.34
72530868|NCT00313716|144590951|SUPERIORITY_OR_OTHER|||||||0.06|||||||Wilcoxon (Mann-Whitney)|||||||.06
72530869|NCT00313716|144590952|SUPERIORITY_OR_OTHER|||||||0.25|||||||Log Rank|||||||.25
72530870|NCT00313716|144590952|SUPERIORITY_OR_OTHER|||||||0.75|||||||Log Rank|||||||.75
72530871|NCT00313716|144590952|SUPERIORITY_OR_OTHER|||||||0.72|||||||Log Rank|||||||.72
72530872|NCT00313716|144590953|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.79||||0.08|TWO_SIDED|95.0|0.93|3.45|||Regression, Cox|||||3.45|.93|.08
72530873|NCT00313716|144590954|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.08||||0.26|TWO_SIDED|95.0|-0.22|0.05|||2-sample test - equality of proportions|||||.05|-.22|.26
72530874|NCT01249404|144590964|SUPERIORITY_OR_OTHER_LEGACY||Least squares (LS) mean difference|-0.1|||=|0.2859|TWO_SIDED|95.0|-0.3|0.1|||ANCOVA||LS Means for each treatment group and treatment comparisons as well as the p-values are obtained from an ANCOVA on the change from baseline with treatment, baseline MAS score, BTX treatment status at baseline and centre as covariates.|The least squares mean change from baseline to Week 4 for MAS in the Dysport® 1000 U and Placebo groups were compared using 2 contrast analyses within a single mixed effect analysis of covariance (ANCOVA) model, controlling for the baseline values, the randomisation stratification factor (BTX treatment status at baseline) and the centre, all as fixed effects.||0.1|-0.3|=0.2859
72530875|NCT01249404|144590964|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.3|||=|0.0091|TWO_SIDED|95.0|-0.5|-0.1|||ANCOVA||LS Means for each treatment group and treatment comparisons as well as the p-values are obtained from an ANCOVA on the change from baseline with treatment, baseline MAS score, BTX treatment status at baseline and centre as covariates.|The least squares mean change from baseline to Week 4 for MAS in the Dysport® 1500 U and Placebo groups were compared using 2 contrast analyses within a single mixed effect ANCOVA model, controlling for the baseline values, the randomisation stratification factor (BTX treatment status at baseline) and the centre, all as fixed effects.||-0.1|-0.5|=0.0091
72625699|NCT00619866|144780996|SUPERIORITY||LS Mean Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.07||0.728|TWO_SIDED|95.0|-0.17|0.12|||Repeated measures ANCOVA||Difference = Elagolix - Placebo|Analysis at week 4. Change from baseline in non-menstrual pelvic pain score was analyzed by a repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for subject, and the baseline-by-time interaction, and the baseline value as a covariate.||0.12|-0.17|0.7280
72530876|NCT01249404|144590965|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.3|||=|0.064|TWO_SIDED|95.0|0.0|0.5|||ANCOVA||LS means for each treatment group and treatment comparisons as well as the p-values are obtained from an ANCOVA on visit results with treatment, BTX treatment status at baseline and centre as covariates.|The mean PGA at Week 4 in the Dysport® 1000 U and Placebo groups were compared using 2 contrast analyses within a single mixed effect ANCOVA model, controlling for the baseline values, the randomisation stratification factor (BTX treatment status at baseline) and the centre, all as fixed effects.||0.5|-0.0|=0.0640
72530877|NCT01249404|144590965|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.3|||=|0.0665|TWO_SIDED|95.0|0.0|0.5|||ANCOVA||LS means for each treatment group and treatment comparisons as well as the p-values are obtained from an ANCOVA on visit results with treatment, BTX treatment status at baseline and centre as covariates.|The mean PGA at Week 4 in the Dysport® 1500 U and Placebo groups were compared using 2 contrast analyses within a single mixed effect ANCOVA model, controlling for the baseline values, the randomisation stratification factor (BTX treatment status at baseline) and the centre, all as fixed effects.||0.5|-0.0|=0.0665
72530878|NCT01249404|144590965|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.2||||0.0466|TWO_SIDED||||||ANCOVA on rank PGA scores||LS means for each treatment group and treatment comparisons and the p-values are obtained from an analysis of variance on visit results based on ranked values with treatment, BTX treatment status at baseline and centre as explanatory variables.|The LS mean rank values were back transformed to the original scale to give ranked PGA scores in an attempt to better normalise the data and restore power.||||0.0466
72530879|NCT01249404|144590965|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.2||||0.0406|TWO_SIDED||||||ANCOVA on rank PGA scores||LS means for each treatment group and treatment comparisons and the p-values are obtained from an analysis of variance on visit results based on ranked values with treatment, BTX treatment status at baseline and centre as explanatory variables.|The LS mean rank values were back transformed to the original scale to give ranked PGA scores in an attempt to better normalise the data and restore power.||||0.0406
72530880|NCT01249404|144590966|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.01|||=|0.7247|TWO_SIDED|95.0|-0.02|0.03|||ANCOVA||LS Means for each treatment group and treatment comparisons as well as the p-values are obtained from an ANCOVA on the change from baseline with treatment, baseline MAS score, BTX treatment status at baseline and centre as covariates.|The least squares mean change from baseline to Week 4 for barefoot comfortable walking speed in the Dysport® 1000 U and Placebo groups were compared using 2 contrast analyses within a single mixed effect analysis of covariance (ANCOVA) model, controlling for the baseline values, the randomisation stratification factor (BTX treatment status at baseline) and the centre, all as fixed effects.||0.03|-0.02|=0.7247
72530881|NCT01249404|144590966|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.01|||=|0.7266|TWO_SIDED|95.0|-0.03|0.02|||ANCOVA||LS Means for each treatment group and treatment comparisons as well as the p-values are obtained from an ANCOVA on the change from baseline with treatment, baseline MAS score, BTX treatment status at baseline and centre as covariates.|The least squares mean change from baseline to Week 4 for barefoot comfortable walking speed in the Dysport® 1500 U and Placebo groups were compared using 2 contrast analyses within a single mixed effect ANCOVA model, controlling for the baseline values, the randomisation stratification factor (BTX treatment status at baseline) and the centre, all as fixed effects.||0.02|-0.03|=0.7266
72530882|NCT02615158|144590988|EQUIVALENCE|If the 95% confidence interval of the difference in the change over time does not include 0, it means that there is a significant difference in the change over time between the two groups.|Slope|0.07|STANDARD_ERROR_OF_MEAN|0.12||0.555|TWO_SIDED|95.0|-0.17|0.31||The alpha for statistical significance is set at 0.05.|Mixed Models Analysis||This is to compare change in maternal lifestyle group to child safety group.|H0: There are no differences between the maternal lifestyle and child safety groups in the change in BMI z-score over time. Mixed models included the interaction between time and intervention, accounting for clustering of the repeated measures within each individual.||0.31|-0.17|0.555
72530883|NCT02615158|144590988|EQUIVALENCE|95% CI|Slope|0.16|STANDARD_ERROR_OF_MEAN|0.12||0.2|TWO_SIDED|95.0|-0.08|0.39||Two-side test|Mixed Models Analysis||This is to compare the Responsive Parenting to the safety intervention group.|||0.39|-0.08|0.200
72572029|NCT02912650|144671811|SUPERIORITY_OR_OTHER||LS Mean Difference|3.25|||<|0.001|TWO_SIDED|95.0|2.68|3.82|||ANOVA|||0 to 2 hours: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||3.82|2.68|<0.001
72572030|NCT02912650|144671811|SUPERIORITY_OR_OTHER||LS Mean Difference|0.63||||0.002|TWO_SIDED|95.0|0.23|1.03|||ANOVA|||0-2 hour:Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.03|0.23|0.002
72572031|NCT02912650|144671811|SUPERIORITY_OR_OTHER||LS Mean Difference|0.86|||<|0.001|TWO_SIDED|95.0|0.46|1.27|||ANOVA|||0-2 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.27|0.46|<0.001
72625700|NCT00619866|144780996|SUPERIORITY||LS Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.07||0.0195|TWO_SIDED|95.0|-0.32|-0.03|||Repeated Measures ANCOVA||Difference = Elagolix - Placebo|Analysis at week 8. Change from baseline in non-menstrual pelvic pain score was analyzed by a repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for subject, and the baseline-by-time interaction, and the baseline value as a covariate.||-0.03|-0.32|0.0195
72625701|NCT00619866|144780996|SUPERIORITY||LS Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.08||0.5589|TWO_SIDED|95.0|-0.19|0.1|||Repeated Measures ANCOVA||Difference = Elagolix - Placebo|Analysis at week 8. Change from baseline in non-menstrual pelvic pain score was analyzed by a repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for subject, and the baseline-by-time interaction, and the baseline value as a covariate.||0.10|-0.19|0.5589
72625702|NCT00619866|144780996|SUPERIORITY||LS Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.08||0.5558|TWO_SIDED|95.0|-0.2|0.11|||Repeated Measures ANCOVA||Difference = Elagolix - Placebo|Analysis at week 12. Change from baseline in non-menstrual pelvic pain score was analyzed by a repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for subject, and the baseline-by-time interaction, and the baseline value as a covariate.||0.11|-0.20|0.5558
72625703|NCT00619866|144780996|SUPERIORITY||LS Mean Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.08||0.7121|TWO_SIDED|95.0|-0.18|0.12|||Repeated Measures ANCOVA||Difference = Elagolix - Placebo|Analysis at week 12. Change from baseline in non-menstrual pelvic pain score was analyzed by a repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for subject, and the baseline-by-time interaction, and the baseline value as a covariate.||0.12|-0.18|0.7121
72625704|NCT00619866|144780997|SUPERIORITY||LS Mean Difference|-0.28|STANDARD_ERROR_OF_MEAN|0.13||0.0286|TWO_SIDED|95.0|-0.54|-0.03|||Repeated Measures ANCOVA||Difference = Elagolix - Placebo|Analysis at week 4. Change from baseline in dysmenorrhea score was analyzed by a repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for subject, and the baseline-by-time interaction, and the baseline value as a covariate.||-0.03|-0.54|0.0286
72572032|NCT02912650|144671811|SUPERIORITY_OR_OTHER||LS Mean Difference|2.62|||<|0.001|TWO_SIDED|95.0|2.05|3.19|||ANOVA|||0-2 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||3.19|2.05|<0.001
72572033|NCT02912650|144671811|SUPERIORITY_OR_OTHER||LS Mean Difference|2.39|||<|0.001|TWO_SIDED|95.0|1.81|2.96|||ANOVA|||0-2 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||2.96|1.81|<0.001
72572034|NCT02912650|144671811|SUPERIORITY_OR_OTHER||LS Mean Difference|0.23||||0.258|TWO_SIDED|95.0|-0.17|0.64|||ANOVA|||0-2 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.64|-0.17|0.258
72572035|NCT02912650|144671811|SUPERIORITY_OR_OTHER||LS Mean Difference|10.77|||<|0.001|TWO_SIDED|95.0|8.79|12.74|||ANOVA|||0 to 6 hours: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||12.74|8.79|<0.001
72572036|NCT02912650|144671811|SUPERIORITY_OR_OTHER||LS Mean Difference|2.29||||0.001|TWO_SIDED|95.0|0.91|3.67|||ANOVA|||0 to 6 hours: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||3.67|0.91|0.001
72572037|NCT02912650|144671811|SUPERIORITY_OR_OTHER||LS Mean Difference|5.33|||<|0.001|TWO_SIDED|95.0|3.93|6.73|||ANOVA|||0 to 6 hours: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||6.73|3.93|<0.001
72572038|NCT02912650|144671811|SUPERIORITY_OR_OTHER||LS Mean Difference|8.48|||<|0.001|TWO_SIDED|95.0|6.51|10.44|||ANOVA|||0 to 6 hours: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||10.44|6.51|<0.001
72625705|NCT00619866|144780997|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.13||0.121|TWO_SIDED|95.0|-0.45|0.05|||Repeated Measures ANCOVA||Difference = Elagolix - Placebo|Analysis at week 4. Change from baseline in dysmenorrhea score was analyzed by a repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for subject, and the baseline-by-time interaction, and the baseline value as a covariate.||0.05|-0.45|0.1210
72625706|NCT00619866|144780997|SUPERIORITY||LS Mean Difference|-0.42|STANDARD_ERROR_OF_MEAN|0.14||0.0024|TWO_SIDED|95.0|-0.68|-0.15|||Repeated Measures ANCOVA||Difference = Elagolix - Placebo|Analysis at week 8. Change from baseline in dysmenorrhea score was analyzed by a repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for subject, and the baseline-by-time interaction, and the baseline value as a covariate.||-0.15|-0.68|0.0024
72625707|NCT00619866|144780997|SUPERIORITY||LS Mean Difference|-0.49|STANDARD_ERROR_OF_MEAN|0.14||0.0003|TWO_SIDED|95.0|-0.76|-0.22|||Repeated Measures ANCOVA||Difference = Elagolix - Placebo|Analysis at week 8. Change from baseline in dysmenorrhea score was analyzed by a repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for subject, and the baseline-by-time interaction, and the baseline value as a covariate.||-0.22|-0.76|0.0003
72625708|NCT00619866|144780997|SUPERIORITY||LS Mean Difference|-0.44|STANDARD_ERROR_OF_MEAN|0.14||0.0021|TWO_SIDED|95.0|-0.72|-0.16|||Repeated Measures ANCOVA||Difference = Elagolix - Placebo|Analysis at week 12. Change from baseline in dysmenorrhea score was analyzed by a repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for subject, and the baseline-by-time interaction, and the baseline value as a covariate.||-0.16|-0.72|0.0021
72530884|NCT02615158|144590989|EQUIVALENCE|95% confidence interval (CI) was estimated. If the 95% CI does not include 0, it means there is significant difference in the change over time between the two groups.|Slope|-0.11|STANDARD_ERROR_OF_MEAN|0.32||0.739|TWO_SIDED|95.0|-0.74|0.52||The alpha for statistical significance is set at 0.05|Mixed Models Analysis||This is to compare maternal lifestyle to child safety group.|H0: There is no difference between maternal lifestyle and child safety groups in the change of BMI over time.||0.52|-0.74|0.739
72530885|NCT02615158|144590989|EQUIVALENCE|The 95% CI was estimated. If it does not include 0, it means that there is a statistically significant difference in the change over time between the two groups.|Slope|-0.04|STANDARD_ERROR_OF_MEAN|0.32||0.904|TWO_SIDED|95.0|-0.66|0.59||The alpha for statistical significance was set at 0.05.|Mixed Models Analysis||This is to compare the responsive parenting group to the child safety group.|H0: There are no differences in the change over time between responsive parenting and child safety groups.||0.59|-0.66|0.904
72625709|NCT00619866|144780997|SUPERIORITY||LS Mean Difference|-0.52|STANDARD_ERROR_OF_MEAN|0.14||0.0003|TWO_SIDED|95.0|-0.8|-0.24|||Repeated Measures ANCOVA||Difference = Elagolix - Placebo|Analysis at week 12. Change from baseline in dysmenorrhea score was analyzed by a repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for subject, and the baseline-by-time interaction, and the baseline value as a covariate.||-0.24|-0.80|0.0003
72625710|NCT00619866|144780998|SUPERIORITY||LS Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.09||0.0603|TWO_SIDED|95.0|-0.34|0.01|||Repeated Measures ANCOVA||Difference = Elagolix - Placebo|Analysis at week 4. Change from baseline in total of non-menstrual pelvic pain and dysmenorrhea scores was analyzed by a repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for subject, and the baseline-by-time interaction, and the baseline value as a covariate.||0.01|-0.34|0.0603
72625711|NCT00619866|144780998|SUPERIORITY||LS Mean Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.09||0.1855|TWO_SIDED|95.0|-0.29|0.06|||Repeated Measures ANCOVA||Difference = Elagolix - Placebo|Analysis at week 4. Change from baseline in total of non-menstrual pelvic pain and dysmenorrhea scores was analyzed by a repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for subject, and the baseline-by-time interaction, and the baseline value as a covariate.||0.06|-0.29|0.1855
72625712|NCT00619866|144780998|SUPERIORITY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.09||0.0012|TWO_SIDED|95.0|-0.48|-0.12|||Repeated Measures ANCOVA||Difference = Elagolix - Placebo|Analysis at week 8. Change from baseline in total of non-menstrual pelvic pain and dysmenorrhea scores was analyzed by a repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for subject, and the baseline-by-time interaction, and the baseline value as a covariate.||-0.12|-0.48|0.0012
72407976|NCT02702401|144324301|SUPERIORITY||Hazard Ratio (HR)|0.781||||0.0238|TWO_SIDED|95.0|0.611|0.998|||Log Rank|One-sided p-value stratified by geographic region, macrovascular invasion and alfa-fetoprotein level.|Cox regression model with Efron's method (treatment as covariate) stratified by geographic region, macrovascular invasion and alfa-fetoprotein level|||0.998|0.611|0.0238
72407977|NCT02702401|144324302|OTHER||Difference in Percent|13.8|||||TWO_SIDED|95.0|7.7|19.5|||||Miettinen \& Nurminen method stratified by geographic region, macrovascular invasion and alfa-fetoprotein level|||19.5|7.7|
72530886|NCT02615158|144590990|EQUIVALENCE|The 95% confidence interval (CI) for the difference in the change over time was estimated. If it does not include 0, it indicates significant difference in the change over time.|Slope|3.31|STANDARD_ERROR_OF_MEAN|2.4||0.168|TWO_SIDED|95.0|-1.4|8.02||Alpha is set at 0.05.|Mixed Models Analysis|||H0 is that there is no difference between maternal lifestyle and child safety groups in the change of HEI 2015 score over time.||8.02|-1.4|0.168
72530887|NCT02615158|144590990|EQUIVALENCE|95% CI was estimated. If it does not include 0, it indicates that there is a significant difference in the change between the two groups.|Slope|0.82|STANDARD_ERROR_OF_MEAN|2.39||0.733|TWO_SIDED|95.0|-3.88|5.52|||Mixed Models Analysis||This is to compare the responsive feeding group to child safety group.|H0 is that there is no difference between the responsive parenting and child safety groups in the change of HEI score over time||5.52|-3.88|0.733
72530888|NCT02615158|144590991|EQUIVALENCE|The 95% CI was estimated. If it does not include 0, it indicates that there is significant difference in the change over time between the two groups.|Slope|3.3|STANDARD_ERROR_OF_MEAN|2.49||0.186|TWO_SIDED|95.0|-1.6|8.2||Alpha is set at 0.05.|Mixed Models Analysis||This is to compare the maternal lifestyle group to the child safety group.|Null hypothesis is that there are no differences between the two groups regarding the change of HEI 2015 score over time.||8.2|-1.6|0.186
72530889|NCT02615158|144590991|EQUIVALENCE|95% CI for the difference in change over time was estimated. If it does not include 0, it indicates that there is significant difference between the two groups.|Slope|-0.03|STANDARD_ERROR_OF_MEAN|2.51||0.99|TWO_SIDED|95.0|-4.97|4.91||Alpha is set to 0.05.|Mixed Models Analysis||This is to compare the responsive parenting group to child safety group.|H0 is there is no difference in the change of maternal HEI score over time between the two groups.||4.91|-4.97|0.990
72530890|NCT02615158|144590992|EQUIVALENCE|A 95% CI was estimated. If it does not include 0, it indicates significant difference in change over time between the two groups.|Slope|23.67|STANDARD_ERROR_OF_MEAN|11.03||0.034|TWO_SIDED|95.0|1.88|45.46||Alpha is set at 0.05.|Mixed Models Analysis||This is for maternal lifestyle group compared to safety control group.|Null hypothesis is there were no differences in the change over time for toddler MVPA across the two groups.||45.46|1.88|0.034
72530891|NCT02615158|144590992|EQUIVALENCE|H0 is that there is no difference between the change of MVPA over time between the two groups.|Slope|13.52|STANDARD_ERROR_OF_MEAN|10.89||0.216|TWO_SIDED|95.0|-7.98|35.03|||Mixed Models Analysis||This is to compare the responsive parenting group to child safety group.|||35.03|-7.98|0.216
72530892|NCT02615158|144590993|EQUIVALENCE|The 95% CI for the difference in the change between the two groups was estimated. If it does not include 0, it indicates that there is a significant difference by group in the change.|Slope|10.97|STANDARD_ERROR_OF_MEAN|4.82||0.024|TWO_SIDED|95.0|1.46|20.48|||Mixed Models Analysis||This is to compare the maternal lifestyle group to the child safety group.|H0 is that there is no difference in the change of maternal MVPA over time between the two groups.||20.48|1.46|0.024
72530893|NCT02615158|144590993|EQUIVALENCE|The 95% CI was estimated. If it does not include 0, it indicates that there is a significant difference by group in the difference.|Slope|0.98|STANDARD_ERROR_OF_MEAN|4.94||0.804|TWO_SIDED|95.0|-8.76|10.72|||Mixed Models Analysis||This is to compare responsive parenting group to child safety group.|H0 is that there is no significant difference in the change of maternal MVPA between the two groups.||10.72|-8.76|0.804
72530894|NCT02615158|144590994|EQUIVALENCE|The 95% CI was estimated. If it does not include 0, it indicates that there is a significant difference by group in the difference.|Slope|-0.36|STANDARD_ERROR_OF_MEAN|0.21||0.056|TWO_SIDED|95.0|-0.78|0.06||Alpha is set at 0.05 for statistical significance.|Mixed Models Analysis||This is to compare maternal lifestyle group to the child safety group.|The 95% CI was estimated. If it does not include 0, it indicates that there is a significant difference by group in the difference.||0.06|-0.78|0.056
72530895|NCT02615158|144590994|EQUIVALENCE|Alpha is set at 0.05 to indicate statistical significance.|Slope|0.03|STANDARD_ERROR_OF_MEAN|0.21||0.896|TWO_SIDED|95.0|-0.39|0.45|||Mixed Models Analysis||This is to compare responsive parenting group to child safety group.|The 95% CI was estimated. If it does not include 0, it indicates that there is a significant difference by group in the difference.||0.45|-0.39|0.896
72530896|NCT02257970|144590996|EQUIVALENCE|The likelihood of rejecting the null hypothesis (equivalence between the two groups) was defined as P\<0.05|||||<|0.0001|||||||t-test, 2 sided|paired t-test||For the analysis, the 4-month post-minus-pre change in this score for ketoprofen was compared.||||<0.0001
72530897|NCT02257970|144590997|EQUIVALENCE|Pre-to-post comparison: the likelihood of rejecting the null hypothesis (equivalence between the two groups) was defined as P\<0.05|||||=|0.6|||||||t-test, 2 sided|Paired t-test||||||=0.6
72530898|NCT02257970|144590997|EQUIVALENCE|Pre-to-Post comparison: The likelihood of rejecting the null hypothesis (equivalence between the two groups) was defined as P\<0.05|||||=|0.01|||||||t-test, 2 sided|paired t-test||||||=0.01
72530899|NCT00883896|144591014|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|-5.9||||0.558|TWO_SIDED|95.0|-25.0|13.3|||Cochran-Mantel-Haenszel|||P-value was assessed from 2-sided Cochran-Mantel-Haenszel (CMH) test stratified by anti-tumor necrosis factor (anti-TNF) prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.||13.3|-25.0|0.558
72530900|NCT00883896|144591014|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|-11.4||||0.251|TWO_SIDED|95.0|-30.1|7.3|||Cochran-Mantel-Haenszel|||P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.||7.3|-30.1|0.251
72407978|NCT02702401|144324304|OTHER||Hazard Ratio (HR)|0.688||||0.0011|TWO_SIDED|95.0|0.54|0.877||One-sided p-value stratified by geographic region, macrovascular invasion and alfa-fetoprotein level.|Log Rank||Cox regression model with Efron's method (treatment as covariate) stratified by geographic region, macrovascular invasion and alfa-fetoprotein level|||0.877|0.540|0.0011
72530901|NCT00883896|144591014|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|-3.7||||0.707|TWO_SIDED|95.0|-21.7|14.4|||Cochran-Mantel-Haenszel|||P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.||14.4|-21.7|0.707
72530902|NCT00883896|144591015|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|-0.1||||0.991|TWO_SIDED|95.0|-14.8|14.7|||Cochran-Mantel-Haenszel|||Week 2: P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.||14.7|-14.8|0.991
72530903|NCT00883896|144591015|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|-4.8||||0.518|TWO_SIDED|95.0|-18.4|8.8|||Cochran-Mantel-Haenszel|||Week 2: P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.||8.8|-18.4|0.518
72530904|NCT00883896|144591015|SUPERIORITY_OR_OTHER_LEGACY||Perecent Difference|0.781||||0.63|TWO_SIDED|95.0|-16.9|9.8|||Cochran-Mantel-Haenszel|||Week 2: P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.||9.8|-16.9|0.630
72407979|NCT04292730|144324321|SUPERIORITY||Odds Ratio (OR)|1.65||||0.0174|TWO_SIDED|95.0|1.092|2.483||P-value was calculated using proportional odds model with treatment as the independent variable.|Proportional odds model|||Primary analysis||2.483|1.092|0.0174
72530905|NCT00883896|144591015|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|9.4||||0.295|TWO_SIDED|95.0|-8.3|27.0|||Cochran-Mantel-Haenszel|||Week 4: P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.||27.0|-8.3|0.295
72530906|NCT00883896|144591015|SUPERIORITY_OR_OTHER_LEGACY||Perecent Difference|-3.4||||0.686|TWO_SIDED|95.0|-19.3|12.5|||Cochran-Mantel-Haenszel|||Week 4: P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.||12.5|-19.3|0.686
72530907|NCT00883896|144591015|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|2.5||||0.772|TWO_SIDED|95.0|-13.2|18.2|||Cochran-Mantel-Haenszel|||Week 4: P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.||18.2|-13.2|0.772
72530908|NCT00883896|144591015|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|12.8||||0.201|TWO_SIDED|95.0|-6.5|32.0|||Cochran-Mantel-Haenszel|||Week 6: P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.||32.0|-6.5|0.201
72530909|NCT00883896|144591015|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|-10.4||||0.256|TWO_SIDED|95.0|-27.3|6.5|||Cochran-Mantel-Haenszel|||Week 6: P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.||6.5|-27.3|0.256
72530910|NCT00883896|144591015|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|6.1||||0.519|TWO_SIDED|95.0|-11.4|23.5|||Cochran-Mantel-Haenszel|||Week 6: P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.||23.5|-11.4|0.519
72530911|NCT00883896|144591015|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|16.7||||0.094|TWO_SIDED|95.0|-1.9|35.2|||Cochran-Mantel-Haenszel|||Week 8: P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.||35.2|-1.9|0.094
72530912|NCT00883896|144591015|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|2.8||||0.76|TWO_SIDED|95.0|-14.4|20.1|||Cochran-Mantel-Haenszel|||Week 8: P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.||20.1|-14.4|0.760
72530913|NCT00883896|144591015|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|0.6||||0.95|TWO_SIDED|95.0|-16.8|18.0|||Cochran-Mantel-Haenszel|||Week 8: P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.||18.0|-16.8|0.950
72530914|NCT00883896|144591015|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|13.6||||0.185|TWO_SIDED|95.0|-5.9|33.0|||Cochran-Mantel-Haenszel|||Week 10: P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.||33.0|-5.9|0.185
72530915|NCT00883896|144591015|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|0.2||||0.982|TWO_SIDED|95.0|-18.8|19.3|||Cochran-Mantel-Haenszel|||Week 10: P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.||19.3|-18.8|0.982
72530916|NCT00883896|144591015|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|-11.6||||0.223|TWO_SIDED|95.0|-29.0|5.8|||Cochran-Mantel-Haenszel|||Week 10: P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.||5.8|-29.0|0.223
72530917|NCT00883896|144591016|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|-0.5||||0.885|TWO_SIDED|95.0|-6.8|5.8|||Cochran-Mantel-Haenszel|||Week 2: P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.||5.8|-6.8|0.885
72530918|NCT00883896|144591016|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|6.1||||0.18|TWO_SIDED|95.0|-3.4|15.6|||Cochran-Mantel-Haenszel|||Week 2: P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.||15.6|-3.4|0.180
72530919|NCT00883896|144591016|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|-2.7||||0.277|TWO_SIDED|95.0|-6.5|1.1|||Cochran-Mantel-Haenszel|||Week 2: P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.||1.1|-6.5|0.277
72530920|NCT00883896|144591016|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|1.7||||0.74|TWO_SIDED|95.0|-7.9|11.3|||Cochran-Mantel-Haenszel|||Week 4: P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.||11.3|-7.9|0.740
72530921|NCT00883896|144591016|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|0.4||||0.934|TWO_SIDED|95.0|-9.3|10.1|||Cochran-Mantel-Haenszel|||Week 4: P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.||10.1|-9.3|0.934
72407980|NCT04292730|144324321|SUPERIORITY||Odds Ratio (OR)|1.31||||0.1826|TWO_SIDED|95.0|0.88|1.952||P-value was calculated using proportional odds model with treatment as the independent variable.|Proportional odds model|||Primary analysis||1.952|0.880|0.1826
72530922|NCT00883896|144591016|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|-0.6||||0.876|TWO_SIDED|95.0|-7.7|6.4|||Cochran-Mantel-Haenszel|||Week 4: P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.||6.4|-7.7|0.876
72530923|NCT00883896|144591016|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|-1.1||||0.842|TWO_SIDED|95.0|-11.4|9.2|||Cochran-Mantel-Haenszel|||Week 6: P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.||9.2|-11.4|0.842
72530924|NCT00883896|144591016|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|4.1||||0.509|TWO_SIDED|95.0|-8.1|16.3|||Cochran-Mantel-Haenszel|||Week 6: P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.||16.3|-8.1|0.509
72530925|NCT00883896|144591016|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|4.0||||0.504|TWO_SIDED|95.0|-7.0|15.0|||Cochran-Mantel-Haenszel|||Week 6: P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.||15.0|-7.0|0.504
72530926|NCT00883896|144591016|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|5.4||||0.373|TWO_SIDED|95.0|-6.3|17.0|||Cochran-Mantel-Haenszel|||Week 8: P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.||17.0|-6.3|0.373
72572039|NCT02912650|144671811|SUPERIORITY_OR_OTHER||LS Mean Difference|5.44|||<|0.001|TWO_SIDED|95.0|3.46|7.42|||ANOVA|||0 to 6 hours: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||7.42|3.46|<0.001
72407981|NCT04292730|144324321|SUPERIORITY||Odds Ratio (OR)|1.65||||0.0168|TWO_SIDED|95.0|1.095|2.497||P-value was calculated using proportional odds model with treatment as the independent variable and baseline clinical status as a nominal covariate.|Proportional odds model|||Secondary analysis||2.497|1.095|0.0168
72407982|NCT04292730|144324321|SUPERIORITY||Odds Ratio (OR)|1.29||||0.2186|TWO_SIDED|95.0|0.862|1.917||P-value was calculated using proportional odds model with treatment as the independent variable and baseline clinical status as a nominal covariate.|Proportional odds model|||Secondary analysis||1.917|0.862|0.2186
72530927|NCT00883896|144591016|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|-3.4||||0.499|TWO_SIDED|95.0|-12.0|5.2|||Cochran-Mantel-Haenszel|||Week 8: P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.||5.2|-12.0|0.499
72530928|NCT00883896|144591016|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|7.0||||0.244|TWO_SIDED|95.0|-4.2|18.3|||Cochran-Mantel-Haenszel|||Week 8: P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.||18.3|-4.2|0.244
72530929|NCT00883896|144591016|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|-0.2||||0.979|TWO_SIDED|95.0|-15.0|14.6|||Cochran-Mantel-Haenszel|||Week 10: P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.||14.6|-15.0|0.979
72530930|NCT00883896|144591016|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|-9.8||||0.166|TWO_SIDED|95.0|-21.8|2.2|||Cochran-Mantel-Haenszel|||Week 10: P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.||2.2|-21.8|0.166
72530931|NCT00883896|144591016|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|0.5||||0.947|TWO_SIDED|95.0|-13.2|14.2|||Cochran-Mantel-Haenszel|||Week 10: P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.||14.2|-13.2|0.947
72572040|NCT02912650|144671811|SUPERIORITY_OR_OTHER||LS Mean Difference|3.04|||<|0.001|TWO_SIDED|95.0|1.65|4.43|||ANOVA|||0 to 6 hours: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||4.43|1.65|<0.001
72572041|NCT02912650|144671811|SUPERIORITY_OR_OTHER||LS Mean Difference|14.68|||<|0.001|TWO_SIDED|95.0|10.74|18.62|||ANOVA|||0 to 12 hours: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||18.62|10.74|<0.001
72625713|NCT00619866|144780998|SUPERIORITY||LS Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.09||0.1002|TWO_SIDED|95.0|-0.33|0.03|||Repeated Measures ANCOVA||Difference = Elagolix - Placebo|Analysis at week 8. Change from baseline in total of non-menstrual pelvic pain and dysmenorrhea scores was analyzed by a repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for subject, and the baseline-by-time interaction, and the baseline value as a covariate.||0.03|-0.33|0.1002
72530932|NCT00883896|144591016|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|8.3||||0.286|TWO_SIDED|95.0|-7.1|23.8|||Cochran-Mantel-Haenszel|||Week 12: P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.||23.8|-7.1|0.286
72530933|NCT00883896|144591016|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|-1.6||||0.822|TWO_SIDED|95.0|-15.0|11.8|||Cochran-Mantel-Haenszel|||Week 12: P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.||11.8|-15.0|0.822
72530934|NCT00883896|144591016|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|-0.1||||0.986|TWO_SIDED|95.0|-12.3|12.1|||Cochran-Mantel-Haenszel|||Week 12: P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.||12.1|-12.3|0.986
72407983|NCT04292730|144324322|SUPERIORITY||Difference in the Percentages|4.8||||0.3633|TWO_SIDED|95.0|-5.2|14.7||P-value was calculated from the Fisher exact test to compare each RDV group and the SOC group.|Fisher Exact|||||14.7|-5.2|0.3633
72530935|NCT00883896|144591017|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|2.5||||0.205|TWO_SIDED|95.0|-2.3|7.4|||Cochran-Mantel-Haenszel|||Week 2: P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.||7.4|-2.3|0.205
72530936|NCT00883896|144591017|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|2.5||||0.188|TWO_SIDED|95.0|-2.3|7.3|||Cochran-Mantel-Haenszel|||Week 2:P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.||7.3|-2.3|0.188
72530937|NCT00883896|144591017|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|0.0|||||TWO_SIDED|95.0|0.0|0.0||||||Week 2: Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.||0.0|0.0|
72530938|NCT00883896|144591017|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|1.1||||0.699|TWO_SIDED|95.0|-4.5|6.6|||Cochran-Mantel-Haenszel|||Week 4:P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.||6.6|-4.5|0.699
72572042|NCT02912650|144671811|SUPERIORITY_OR_OTHER||LS Mean Difference|3.16||||0.024|TWO_SIDED|95.0|0.41|5.91|||ANOVA|||0 to 12 hours: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||5.91|0.41|0.024
72572043|NCT02912650|144671811|SUPERIORITY_OR_OTHER||LS Mean Difference|7.94|||<|0.001|TWO_SIDED|95.0|5.15|10.73|||ANOVA|||0 to 12 hours: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||10.73|5.15|<0.001
72572044|NCT02912650|144671811|SUPERIORITY_OR_OTHER||LS Mean Difference|11.52|||<|0.001|TWO_SIDED|95.0|7.59|15.45|||ANOVA|||0 to 12 hours: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||15.45|7.59|<0.001
72572045|NCT02912650|144671811|SUPERIORITY_OR_OTHER||LS Mean Difference|6.75|||<|0.001||95.0|2.79|10.71|||ANOVA|||0 to 12 hours: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||10.71|2.79|<0.001
72572046|NCT02912650|144671811|SUPERIORITY_OR_OTHER||LS Mean Difference|4.78|||<|0.001|TWO_SIDED|95.0|2.0|7.56|||ANOVA|||0 to 12 hours: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||7.56|2.0|<0.001
72572047|NCT02912650|144671812|SUPERIORITY_OR_OTHER||LS Mean Difference|5.37|||<|0.001|TWO_SIDED|95.0|4.42|6.32|||ANOVA|||0-2 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||6.32|4.42|<0.001
72572048|NCT02912650|144671812|SUPERIORITY_OR_OTHER||LS Mean Difference|1.07||||0.002|TWO_SIDED|95.0|0.4|1.74|||ANOVA|||0-2 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.74|0.40|0.002
72572049|NCT02912650|144671812|SUPERIORITY_OR_OTHER||LS Mean Difference|1.45|||<|0.001|TWO_SIDED|95.0|0.77|2.13|||ANOVA|||0-2 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||2.13|0.77|<0.001
72572050|NCT02912650|144671812|SUPERIORITY_OR_OTHER||LS Mean Difference|4.3|||<|0.001|TWO_SIDED|95.0|3.35|5.25|||ANOVA|||0-2 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||5.25|3.35|<0.001
72572051|NCT02912650|144671812|SUPERIORITY_OR_OTHER||LS Mean Difference|3.92|||<|0.001|TWO_SIDED|95.0|2.96|4.88|||ANOVA|||0-2 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||4.88|2.96|<0.001
72572052|NCT02912650|144671812|SUPERIORITY_OR_OTHER||LS Mean Difference|0.38||||0.268|TWO_SIDED|95.0|-0.29|1.05|||ANOVA|||0-2 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.05|-0.29|0.268
72572053|NCT02912650|144671812|SUPERIORITY_OR_OTHER||LS Mean Difference|17.99|||<|0.001|TWO_SIDED|95.0|14.69|21.28|||ANOVA|||0-6 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||21.28|14.69|<0.001
72572054|NCT02912650|144671812|SUPERIORITY_OR_OTHER||LS Mean Difference|3.87|||<|0.001|TWO_SIDED|95.0|1.57|6.17|||ANOVA|||0-6 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||6.17|1.57|<0.001
72572055|NCT02912650|144671812|SUPERIORITY_OR_OTHER||LS Mean Difference|8.81|||<|0.001|TWO_SIDED|95.0|6.48|11.15|||ANOVA|||0-6 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||11.15|6.48|<0.001
72572056|NCT02912650|144671812|SUPERIORITY_OR_OTHER||LS Mean Difference|14.12|||<|0.001|TWO_SIDED|95.0|10.83|17.4|||ANOVA|||0-6 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||17.40|10.83|<0.001
72530939|NCT00883896|144591017|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|5.4||||0.155|TWO_SIDED|95.0|-3.0|13.8|||Cochran-Mantel-Haenszel|||Week 4:P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.||13.8|-3.0|0.155
72530940|NCT00883896|144591017|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|-1.0||||0.546|TWO_SIDED|95.0|-2.9|0.9|||Cochran-Mantel-Haenszel|||Week 4:P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.||0.9|-2.9|0.546
72530941|NCT00883896|144591017|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|2.5||||0.205|TWO_SIDED|95.0|-2.3|7.4|||Cochran-Mantel-Haenszel|||Week 6:P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.||7.4|-2.3|0.205
72530942|NCT00883896|144591017|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|2.2||||0.269|TWO_SIDED|95.0|-1.8|6.1|||Cochran-Mantel-Haenszel|||Week 6:P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.||6.1|-1.8|0.269
72530943|NCT00883896|144591017|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|2.0||||0.723|TWO_SIDED|95.0|-1.6|5.6|||Cochran-Mantel-Haenszel|||Week 6: P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.||5.6|-1.6|0.723
72530944|NCT00883896|144591017|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|2.5||||0.205|TWO_SIDED|95.0|-2.3|7.4|||Cochran-Mantel-Haenszel|||Week 8: P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.||7.4|-2.3|0.205
72530945|NCT00883896|144591017|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|0.0|||||TWO_SIDED|95.0|0.0|0.0||||||Week 8: Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the cochran method.||0.0|0.0|
72572057|NCT02912650|144671812|SUPERIORITY_OR_OTHER||LS Mean Difference|9.17|||<|0.001|TWO_SIDED|95.0|5.86|12.48|||ANOVA|||0-6 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||12.48|5.86|<0.001
72572058|NCT02912650|144671812|SUPERIORITY_OR_OTHER||LS Mean Difference|4.94|||<|0.001|TWO_SIDED|95.0|2.62|7.27|||ANOVA|||0-6 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||7.27|2.62|<0.001
72572059|NCT02912650|144671812|SUPERIORITY_OR_OTHER||LS Mean Difference|21.94|||<|0.001|TWO_SIDED|95.0|17.52|26.37|||ANOVA|||0-8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||26.37|17.52|<0.001
72572060|NCT02912650|144671812|SUPERIORITY_OR_OTHER||LS Mean Difference|5.0||||0.002|TWO_SIDED|95.0|1.91|8.09|||ANOVA|||0-8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||8.09|1.91|0.002
72625714|NCT00619866|144780998|SUPERIORITY||LS Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.09||0.0568|TWO_SIDED|95.0|-0.36|0.01|||Repeated Measures ANCOVA||Difference = Elagolix - Placebo|Analysis at week 12. Change from baseline in total of non-menstrual pelvic pain and dysmenorrhea scores was analyzed by a repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for subject, and the baseline-by-time interaction, and the baseline value as a covariate.||0.01|-0.36|0.0568
72572061|NCT02912650|144671812|SUPERIORITY_OR_OTHER||LS Mean Difference|11.43|||<|0.001|TWO_SIDED|95.0|8.29|14.56|||ANOVA|||0-8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||14.56|8.29|<0.001
72572062|NCT02912650|144671812|SUPERIORITY_OR_OTHER||LS Mean Difference|16.94|||<|0.001|TWO_SIDED|95.0|12.53|21.36|||ANOVA|||0-8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||21.36|12.53|<0.001
72572063|NCT02912650|144671812|SUPERIORITY_OR_OTHER||LS Mean Difference|10.52|||<|0.001|TWO_SIDED|95.0|6.07|14.97|||ANOVA|||0-8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||14.97|6.07|<0.001
72407984|NCT04292730|144324322|SUPERIORITY||Difference in the Percentages|12.0||||0.0201|TWO_SIDED|95.0|1.6|21.8||P-value was calculated from the Fisher exact test to compare each RDV group and the SOC group.|Fisher Exact|||||21.8|1.6|0.0201
72572064|NCT02912650|144671812|SUPERIORITY_OR_OTHER||LS Mean Difference|6.43|||<|0.001|TWO_SIDED|95.0|3.3|9.55|||ANOVA|||0-8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||9.55|3.30|<0.001
72572065|NCT02912650|144671812|SUPERIORITY_OR_OTHER||LS Mean Difference|25.1|||<|0.001|TWO_SIDED|95.0|18.57|31.63|||ANOVA|||0-12 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||31.63|18.57|<0.001
72572066|NCT02912650|144671812|SUPERIORITY_OR_OTHER||LS Mean Difference|5.3||||0.023|TWO_SIDED|95.0|0.74|9.86|||ANOVA|||0-12 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||9.86|0.74|0.023
72572067|NCT02912650|144671812|SUPERIORITY_OR_OTHER||LS Mean Difference|13.17|||<|0.001|TWO_SIDED|95.0|8.55|17.8|||ANOVA|||0-12 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||17.80|8.55|<0.001
72572068|NCT02912650|144671812|SUPERIORITY_OR_OTHER||LS Mean Difference|19.8|||<|0.001|TWO_SIDED|95.0|13.28|26.31|||ANOVA|||0-12 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||26.31|13.28|<0.001
72572069|NCT02912650|144671812|SUPERIORITY_OR_OTHER||LS Mean Difference|11.93|||<|0.001|TWO_SIDED|95.0|5.36|18.49|||ANOVA|||0-12 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||18.49|5.36|<0.001
72530946|NCT00883896|144591017|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|4.0||||0.125|TWO_SIDED|95.0|-1.3|9.4|||Cochran-Mantel-Haenszel|||Week 8:P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.||9.4|-1.3|0.125
72530947|NCT00883896|144591017|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|5.0||||0.071|TWO_SIDED|95.0|-1.7|11.8|||Cochran-Mantel-Haenszel|||Week 10:P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.||11.8|-1.7|0.071
72530948|NCT00883896|144591017|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|2.0||||0.317|TWO_SIDED|95.0|-1.2|5.1|||Cochran-Mantel-Haenszel|||Week 10:P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.||5.1|-1.2|0.317
72530949|NCT00883896|144591017|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|2.0||||0.28|TWO_SIDED|95.0|-1.6|5.6|||Cochran-Mantel-Haenszel|||Week 10:P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.||5.6|-1.6|0.280
72530950|NCT00883896|144591017|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|0.6||||0.892|TWO_SIDED|95.0|-7.6|8.8|||Cochran-Mantel-Haenszel|||Week 12:P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.||8.8|-7.6|0.892
72530951|NCT00883896|144591017|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|-0.5||||0.903|TWO_SIDED|95.0|-8.3|7.2|||Cochran-Mantel-Haenszel|||Week 12:P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.||7.2|-8.3|0.903
72530952|NCT00883896|144591017|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|-1.7||||0.625|TWO_SIDED|95.0|-7.2|3.8|||Cochran-Mantel-Haenszel|||Week 12:P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.||3.8|-7.2|0.625
72530953|NCT00883896|144591029|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9|||||||Cochran-Mantel-Haenszel|||Week 2: P-value was assessed from 2-sided stratified CMH row mean test by anti-TNF prior use and geographic region of the site.||||0.900
72530954|NCT00883896|144591029|SUPERIORITY_OR_OTHER_LEGACY|||||||0.522|||||||Cochran-Mantel-Haenszel|||Week 2: P-value was assessed from 2-sided stratified CMH row mean test by anti-TNF prior use and geographic region of the site.||||0.522
72530955|NCT00883896|144591029|SUPERIORITY_OR_OTHER_LEGACY|||||||0.147|||||||Cochran-Mantel-Haenszel|||Week 2: P-value was assessed from 2-sided stratified CMH row mean test by anti-TNF prior use and geographic region of the site.||||0.147
72530956|NCT00883896|144591029|SUPERIORITY_OR_OTHER_LEGACY|||||||0.534|||||||Cochran-Mantel-Haenszel|||Week 2: P-value was assessed from 2-sided stratified CMH row mean test by anti-TNF prior use and geographic region of the site.||||0.534
72530957|NCT00883896|144591029|SUPERIORITY_OR_OTHER_LEGACY|||||||0.206|||||||Cochran-Mantel-Haenszel|||Week 2: P-value was assessed from 2-sided stratified CMH row mean test by anti-TNF prior use and geographic region of the site.||||0.206
72530958|NCT00883896|144591029|SUPERIORITY_OR_OTHER_LEGACY|||||||0.07|||||||Cochran-Mantel-Haenszel|||Week 2: P-value was assessed from 2-sided stratified CMH row mean test by anti-TNF prior use and geographic region of the site.||||0.070
72530959|NCT00883896|144591029|SUPERIORITY_OR_OTHER_LEGACY|||||||0.936|||||||Cochran-Mantel-Haenszel|||Week 4: P-value was assessed from 2-sided stratified CMH row mean test by anti-TNF prior use and geographic region of the site.||||0.936
72530960|NCT00883896|144591029|SUPERIORITY_OR_OTHER_LEGACY|||||||0.625|||||||Cochran-Mantel-Haenszel|||Week 4: P-value was assessed from 2-sided stratified CMH row mean test by anti-TNF prior use and geographic region of the site.||||0.625
72572070|NCT02912650|144671812|SUPERIORITY_OR_OTHER||LS Mean Difference|7.87|||<|0.001|TWO_SIDED|95.0|3.27|12.48|||ANOVA|||0-12 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||12.48|3.27|<0.001
72530961|NCT00883896|144591029|SUPERIORITY_OR_OTHER_LEGACY|||||||0.586|||||||Cochran-Mantel-Haenszel|||Week 4: P-value was assessed from 2-sided stratified CMH row mean test by anti-TNF prior use and geographic region of the site.||||0.586
72530962|NCT00883896|144591029|SUPERIORITY_OR_OTHER_LEGACY|||||||0.685|||||||Cochran-Mantel-Haenszel|||Week 4: P-value was assessed from 2-sided stratified CMH row mean test by anti-TNF prior use and geographic region of the site.||||0.685
72530963|NCT00883896|144591029|SUPERIORITY_OR_OTHER_LEGACY|||||||0.34|||||||Cochran-Mantel-Haenszel|||Week 4: P-value was assessed from 2-sided stratified CMH row mean test by anti-TNF prior use and geographic region of the site.||||0.340
72572071|NCT02912650|144671812|SUPERIORITY_OR_OTHER||LS Mean Difference|6.61|||<|0.001|TWO_SIDED|95.0|4.61|8.62|||ANOVA|||6-8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||8.62|4.61|<0.001
72530964|NCT00883896|144591029|SUPERIORITY_OR_OTHER_LEGACY|||||||0.212|||||||Cochran-Mantel-Haenszel|||Week 4: P-value was assessed from 2-sided stratified CMH row mean test by anti-TNF prior use and geographic region of the site.||||0.212
72530965|NCT00883896|144591029|SUPERIORITY_OR_OTHER_LEGACY|||||||0.455|||||||Cochran-Mantel-Haenszel|||Week 6: P-value was assessed from 2-sided stratified CMH row mean test by anti-TNF prior use and geographic region of the site.||||0.455
72530966|NCT00883896|144591029|SUPERIORITY_OR_OTHER_LEGACY|||||||0.145|||||||Cochran-Mantel-Haenszel|||Week 6: P-value was assessed from 2-sided stratified CMH row mean test by anti-TNF prior use and geographic region of the site.||||0.145
72572072|NCT02912650|144671812|SUPERIORITY_OR_OTHER||LS Mean Difference|1.74||||0.015|TWO_SIDED|95.0|0.34|3.14|||ANOVA|||6-8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||3.14|0.34|0.015
72625715|NCT00619866|144780998|SUPERIORITY||LS Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.09||0.119|TWO_SIDED|95.0|-0.33|0.04|||Repeated Measures ANCOVA||Difference = Elagolix - Placebo|Analysis at week 12. Change from baseline in total of non-menstrual pelvic pain and dysmenorrhea scores was analyzed by a repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for subject, and the baseline-by-time interaction, and the baseline value as a covariate.||0.04|-0.33|0.1190
72625716|NCT01474109|144781025|SUPERIORITY_OR_OTHER||NB-2 estimate of new DUs per patient|1.103||||0.706|TWO_SIDED|95.0|0.663|1.834|||negative binomial-2 regression (NB-2)||The estimated value corresponds to the treatment effect i.e. the ratio between the estimated number of new DUs in Macitentan 3 mg and in Placebo|||1.834|0.663|0.706
72530967|NCT00883896|144591029|SUPERIORITY_OR_OTHER_LEGACY|||||||0.66|||||||Cochran-Mantel-Haenszel|||Week 6: P-value was assessed from 2-sided stratified CMH row mean test by anti-TNF prior use and geographic region of the site.||||0.660
72530968|NCT00883896|144591029|SUPERIORITY_OR_OTHER_LEGACY|||||||0.05|||||||Cochran-Mantel-Haenszel|||Week 6: P-value was assessed from 2-sided stratified CMH row mean test by anti-TNF prior use and geographic region of the site.||||0.050
72530969|NCT00883896|144591029|SUPERIORITY_OR_OTHER_LEGACY|||||||0.428|||||||Cochran-Mantel-Haenszel|||Week 6: P-value was assessed from 2-sided stratified CMH row mean test by anti-TNF prior use and geographic region of the site.||||0.428
72530970|NCT00883896|144591029|SUPERIORITY_OR_OTHER_LEGACY|||||||0.16|||||||Cochran-Mantel-Haenszel|||Week 6: P-value was assessed from 2-sided stratified CMH row mean test by anti-TNF prior use and geographic region of the site.||||0.160
72530971|NCT00883896|144591029|SUPERIORITY_OR_OTHER_LEGACY|||||||0.757|||||||Cochran-Mantel-Haenszel|||Week 8: P-value was assessed from 2-sided stratified CMH row mean test by anti-TNF prior use and geographic region of the site.||||0.757
72530972|NCT00883896|144591029|SUPERIORITY_OR_OTHER_LEGACY|||||||0.408|||||||Cochran-Mantel-Haenszel|||Week 8: P-value was assessed from 2-sided stratified CMH row mean test by anti-TNF prior use and geographic region of the site.||||0.408
72530973|NCT00883896|144591029|SUPERIORITY_OR_OTHER_LEGACY|||||||0.983|||||||Cochran-Mantel-Haenszel|||Week 8: P-value was assessed from 2-sided stratified CMH row mean test by anti-TNF prior use and geographic region of the site.||||0.983
72530974|NCT00883896|144591029|SUPERIORITY_OR_OTHER_LEGACY|||||||0.374|||||||Cochran-Mantel-Haenszel|||Week 8: P-value was assessed from 2-sided stratified CMH row mean test by anti-TNF prior use and geographic region of the site.||||0.374
72530975|NCT00883896|144591029|SUPERIORITY_OR_OTHER_LEGACY|||||||0.992|||||||Cochran-Mantel-Haenszel|||Week 8: P-value was assessed from 2-sided stratified CMH row mean test by anti-TNF prior use and geographic region of the site.||||0.992
72530976|NCT00883896|144591029|SUPERIORITY_OR_OTHER_LEGACY|||||||0.422|||||||Cochran-Mantel-Haenszel|||Week 8: P-value was assessed from 2-sided stratified CMH row mean test by anti-TNF prior use and geographic region of the site.||||0.422
72530977|NCT00883896|144591029|SUPERIORITY_OR_OTHER_LEGACY|||||||0.743|||||||Cochran-Mantel-Haenszel|||Week 10: P-value was assessed from 2-sided stratified CMH row mean test by anti-TNF prior use and geographic region of the site.||||0.743
72530978|NCT00883896|144591029|SUPERIORITY_OR_OTHER_LEGACY|||||||0.188|||||||Cochran-Mantel-Haenszel|||Week 10: P-value was assessed from 2-sided stratified CMH row mean test by anti-TNF prior use and geographic region of the site.||||0.188
72530979|NCT00883896|144591029|SUPERIORITY_OR_OTHER_LEGACY|||||||0.385|||||||Cochran-Mantel-Haenszel|||Week 10: P-value was assessed from 2-sided stratified CMH row mean test by anti-TNF prior use and geographic region of the site.||||0.385
72530980|NCT00883896|144591029|SUPERIORITY_OR_OTHER_LEGACY|||||||0.148|||||||Cochran-Mantel-Haenszel|||Week 10: P-value was assessed from 2-sided stratified CMH row mean test by anti-TNF prior use and geographic region of the site.||||0.148
72530981|NCT00883896|144591029|SUPERIORITY_OR_OTHER_LEGACY|||||||0.304|||||||Cochran-Mantel-Haenszel|||Week 10: P-value was assessed from 2-sided stratified CMH row mean test by anti-TNF prior use and geographic region of the site.||||0.304
72530982|NCT00883896|144591029|SUPERIORITY_OR_OTHER_LEGACY|||||||0.552|||||||Cochran-Mantel-Haenszel|||Week 10: P-value was assessed from 2-sided stratified CMH row mean test by anti-TNF prior use and geographic region of the site.||||0.552
72530983|NCT00883896|144591029|SUPERIORITY_OR_OTHER_LEGACY|||||||0.494|||||||Cochran-Mantel-Haenszel|||Week 12: P-value was assessed from 2-sided stratified CMH row mean test by anti-TNF prior use and geographic region of the site.||||0.494
72530984|NCT00883896|144591029|SUPERIORITY_OR_OTHER_LEGACY|||||||0.421|||||||Cochran-Mantel-Haenszel|||Week 12: P-value was assessed from 2-sided stratified CMH row mean test by anti-TNF prior use and geographic region of the site.||||0.421
72530985|NCT00883896|144591029|SUPERIORITY_OR_OTHER_LEGACY|||||||0.418|||||||Cochran-Mantel-Haenszel|||Week 12: P-value was assessed from 2-sided stratified CMH row mean test by anti-TNF prior use and geographic region of the site.||||0.418
72530986|NCT00883896|144591029|SUPERIORITY_OR_OTHER_LEGACY|||||||0.235|||||||Cochran-Mantel-Haenszel|||Week 12: P-value was assessed from 2-sided stratified CMH row mean test by anti-TNF prior use and geographic region of the site.||||0.235
72530987|NCT00883896|144591029|SUPERIORITY_OR_OTHER_LEGACY|||||||0.268|||||||Cochran-Mantel-Haenszel|||Week 12: P-value was assessed from 2-sided stratified CMH row mean test by anti-TNF prior use and geographic region of the site.||||0.268
72530988|NCT00883896|144591029|SUPERIORITY_OR_OTHER_LEGACY|||||||0.957|||||||Cochran-Mantel-Haenszel|||Week 12: P-value was assessed from 2-sided stratified CMH row mean test by anti-TNF prior use and geographic region of the site.||||0.957
72530989|NCT01856920|144591049|EQUIVALENCE|Alpha= 0.05||||||0.376|||||||Rank-Sum|||||||0.3760
72530990|NCT00174460|144591065|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.991|STANDARD_ERROR_OF_MEAN|0.1067|<|0.001|TWO_SIDED|95.0|0.773|1.21|||ANCOVA|Results from analysis of covariance method (ANCOVA) adjusted for baseline height SDS and target height SDS; Last observation carried forward (LOCF).||Treatment difference||1.210|0.773|<0.001
72530991|NCT00174460|144591066|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.415|STANDARD_ERROR_OF_MEAN|0.395|<|0.001|TWO_SIDED|95.0|3.605|5.225|||ANCOVA|Results from ANCOVA adjusted for baseline growth velocity, target height SDS, sex, and age; LOCF.||Treatment difference Month 12||5.225|3.605|<0.001
72530992|NCT00174460|144591066|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.884|STANDARD_ERROR_OF_MEAN|0.5327||0.108|TWO_SIDED|95.0|-1.977|0.208|||ANCOVA|Results from ANCOVA adjusted for baseline growth velocity, target height SDS, sex, and age; LOCF.||Treatment difference Month 24||0.208|-1.977|0.108
72530993|NCT00174460|144591067|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.074|STANDARD_ERROR_OF_MEAN|0.7089||0.141|TWO_SIDED|95.0|-2.524|0.376|||ANCOVA|Results from ANCOVA adjusted for baseline growth velocity SDS and target height SDS; LOCF.||Treatment difference||0.376|-2.524|0.141
72530994|NCT00174460|144591068|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.54|STANDARD_ERROR_OF_MEAN|0.3661|<|0.001|TWO_SIDED|95.0|3.789|5.291|||ANCOVA|Results from ANCOVA adjusted for baseline height, target height SDS, sex, and age; LOCF.||Treatment difference Month 12||5.291|3.789|<0.001
72530995|NCT00174460|144591068|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.064|STANDARD_ERROR_OF_MEAN|0.9822|<|0.001|TWO_SIDED|95.0|2.049|6.08|||ANCOVA|Results from ANCOVA adjusted for baseline height, target height SDS, sex, and age; LOCF.||Treatment difference Month 24||6.080|2.049|<0.001
72530996|NCT00174460|144591069|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.719|STANDARD_ERROR_OF_MEAN|0.1606|<|0.001|TWO_SIDED|95.0|0.39|1.047|||ANCOVA|Results from ANCOVA adjusted for baseline height SDS and target height SDS; LOCF.||Treatment difference Month 24||1.047|0.390|<0.001
72530997|NCT00174460|144591070|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.7|STANDARD_ERROR_OF_MEAN|0.497|<|0.001|TWO_SIDED|95.0|-3.73|-1.68|||ANCOVA|Results from ANCOVA adjusted for baseline skinfold thickness, target height SDS, age, and sex; LOCF.||Treatment difference Month 12||-1.68|-3.73|<0.001
72530998|NCT00174460|144591070|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.48|STANDARD_ERROR_OF_MEAN|0.758||0.537|TWO_SIDED|95.0|-2.04|1.09|||ANCOVA|Results from ANCOVA adjusted for baseline skinfold thickness, target height SDS, age, and sex; LOCF.||Treatment difference Month 24||1.09|-2.04|0.537
72530999|NCT00174460|144591071|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.37|STANDARD_ERROR_OF_MEAN|0.405||0.364|TWO_SIDED|95.0|-1.21|0.46|||ANCOVA|Results from ANCOVA adjusted for baseline skinfold thickness, target height SDS, sex, and age; LOCF.||Treatment difference Month 12||0.46|-1.21|0.364
72531000|NCT00174460|144591071|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.23|STANDARD_ERROR_OF_MEAN|0.345||0.506|TWO_SIDED|95.0|-0.94|0.48|||ANCOVA|Results from ANCOVA adjusted for baseline skinfold thickness, target height SDS, sex, and age; LOCF.||Treatment difference Month 24||0.48|-0.94|0.506
72531001|NCT00174460|144591072|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.06|STANDARD_ERROR_OF_MEAN|1.188||0.959|TWO_SIDED|95.0|-2.42|2.54|||ANCOVA|Results from ANCOVA adjusted for baseline skinfold thickness, target height SDS, sex, and age; LOCF.||Treatment difference Month 12||2.54|-2.42|0.959
72531002|NCT00174460|144591072|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.11|STANDARD_ERROR_OF_MEAN|1.065||0.919|TWO_SIDED|95.0|-2.11|2.32|||ANCOVA|Results from ANCOVA adjusted for baseline skinfold thickness, target height SDS, sex, and age; LOCF.||Treatment difference Month 24||2.32|-2.11|0.919
72531003|NCT00174460|144591073|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.892|STANDARD_ERROR_OF_MEAN|0.8161||0.336|TWO_SIDED|95.0|-3.158|1.374|||ANCOVA|Results from ANCOVA adjusted for baseline volumetric cortical bone mineral density SDS and target height SDS; LOCF.||Treatment difference Month 12||1.374|-3.158|0.336
72531004|NCT00174460|144591073|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.717|STANDARD_ERROR_OF_MEAN|0.6027||0.3|TWO_SIDED|95.0|-0.956|2.391|||ANCOVA|Results from ANCOVA adjusted for baseline volumetric cortical bone mineral density SDS and target height SDS; LOCF.||Treatment difference Month 24||2.391|-0.956|0.300
72531005|NCT00174460|144591074|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.615|STANDARD_ERROR_OF_MEAN|0.6591|<|0.001|TWO_SIDED|95.0|4.266|6.963|||ANCOVA|Results from ANCOVA adjusted for baseline growth velocity SDS and target height SDS; LOCF.||Treatment difference||6.963|4.266|<0.001
72625717|NCT01474109|144781025|SUPERIORITY_OR_OTHER||NB-2 estimate of new DUs per patient|1.268||||0.36|TWO_SIDED|95.0|0.763|2.106|||negative binomial-2 regression (NB-2)||The estimated value corresponds to the treatment effect i.e. the ratio between the estimated number of new DUs in Macitentan 10 mg and in Placebo|||2.106|0.763|0.360
72625718|NCT01474109|144781026|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.875||||0.667|TWO_SIDED|95.0|0.477|1.606|||Chi-squared|||||1.606|0.477|0.6670
72531006|NCT00174460|144591075|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.482|STANDARD_ERROR_OF_MEAN|0.9666||0.653|TWO_SIDED|95.0|-3.558|2.595|||ANCOVA|Results from ANCOVA adjusted for baseline cortical cross-sectional area SDS and target height SDS; LOCF.||Treatment difference Month 12||2.595|-3.558|0.653
72531007|NCT00174460|144591075|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.205|STANDARD_ERROR_OF_MEAN|0.8991||0.251|TWO_SIDED|95.0|-3.701|1.292|||ANCOVA|Results from ANCOVA adjusted for baseline cortical cross-sectional area SDS and target height SDS; LOCF.||Treatment difference Month 24||1.292|-3.701|0.251
72531008|NCT00174460|144591076|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.135|STANDARD_ERROR_OF_MEAN|1.1499||0.914|TWO_SIDED|95.0|-3.524|3.795|||ANCOVA|Results from ANCOVA adjusted for baseline total cross-sectional area SDS and target height SDS; LOCF.||Treatment difference Month 12||3.795|-3.524|0.914
72531009|NCT00174460|144591076|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.292|STANDARD_ERROR_OF_MEAN|0.4432||0.547|TWO_SIDED|95.0|-0.939|1.522|||ANCOVA|Results from ANCOVA adjusted for baseline total cross-sectional area SDS and target height SDS; LOCF.||Treatment difference Month 24||1.522|-0.939|0.547
72531010|NCT00174460|144591077|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.31|STANDARD_ERROR_OF_MEAN|0.4542||0.007|TWO_SIDED|95.0|1.049|3.572|||ANCOVA|Results from ANCOVA adjusted for baseline muscle cross-sectional area SDS and target height SDS; LOCF.||Treatment difference Month 12||3.572|1.049|0.007
72531011|NCT00174460|144591077|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.626|STANDARD_ERROR_OF_MEAN|0.6536||0.068|TWO_SIDED|95.0|-0.189|3.44|||ANCOVA|Results from ANCOVA adjusted for baseline muscle cross-sectional area SDS and target height SDS; LOCF.||Treatment difference Month 24||3.440|-0.189|0.068
72531012|NCT00174460|144591080|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.56|STANDARD_ERROR_OF_MEAN|0.5061||0.331|TWO_SIDED|95.0|-0.846|1.965|||ANCOVA|Results from ANCOVA adjusted for baseline strength-strain index SDS and target height SDS; LOCF.||Treatment difference Month 12||1.965|-0.846|0.331
72531013|NCT00174460|144591080|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.114|STANDARD_ERROR_OF_MEAN|0.4703||0.82|TWO_SIDED|95.0|-1.192|1.42|||ANCOVA|Results from ANCOVA adjusted for baseline strength-strain index SDS and target height SDS; LOCF.||Treatment difference Month 24||1.420|-1.192|0.820
72625719|NCT01474109|144781026|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.832||||0.5518|TWO_SIDED|95.0|0.454|1.524|||Chi-squared|||||1.524|0.454|0.5518
72625720|NCT01474109|144781027|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.696||||0.3625|TWO_SIDED|95.0|0.319|1.518|||Chi-squared|||||1.518|0.319|0.3625
72572073|NCT02912650|144671812|SUPERIORITY_OR_OTHER||LS Mean Difference|4.34|||<|0.001|TWO_SIDED|95.0|2.92|5.76|||ANOVA|||6-8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||5.76|2.92|<0.001
72572074|NCT02912650|144671812|SUPERIORITY_OR_OTHER||LS Mean Difference|4.87|||<|0.001|TWO_SIDED|95.0|2.87|6.88|||ANOVA|||6-8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||6.88|2.87|<0.001
72572075|NCT02912650|144671812|SUPERIORITY_OR_OTHER||LS Mean Difference|2.27||||0.028|TWO_SIDED|95.0|0.25|4.28|||ANOVA|||6-8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||4.28|0.25|0.028
72625721|NCT01474109|144781027|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.03||||0.9362|TWO_SIDED|95.0|0.498|2.133|||Chi-squared|||||2.133|0.498|0.9362
72531014|NCT00174460|144591081|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.09|STANDARD_ERROR_OF_MEAN|0.42||0.844|TWO_SIDED|95.0|-0.88|1.05|||ANCOVA|Results from ANCOVA adjusted for baseline hand grip strength SDS and target height SDS; LOCF.||Treatment difference Month 12||1.05|-0.88|0.844
72625722|NCT01474109|144781028|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0||||0.863|TWO_SIDED|95.0|-0.1|0.2|||ANCOVA|||||0.2|-0.1|0.863
72531015|NCT00174460|144591081|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.22|STANDARD_ERROR_OF_MEAN|0.329||0.519|TWO_SIDED|95.0|-0.52|0.96|||ANCOVA|Results from ANCOVA adjusted for baseline hand grip strength SDS and target height SDS; LOCF.||Treatment difference Month 24||0.96|-0.52|0.519
72531016|NCT00174460|144591084|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.998|STANDARD_ERROR_OF_MEAN|0.1095|<|0.001|TWO_SIDED|95.0|0.778|1.219|||Mixed models analysis|Results from repeated measures mixed models analysis adjusted for baseline height SDS, visit, visit\*treatment and target height SDS.||Treatment difference Month 12||1.219|0.778|<0.001
72572076|NCT02912650|144671812|SUPERIORITY_OR_OTHER||LS Mean Difference|2.61|||<|0.001|TWO_SIDED|95.0|1.19|4.02|||ANOVA|||6-8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||4.02|1.19|<0.001
72572077|NCT02912650|144671813|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-36.56|||<|0.001|TWO_SIDED|95.0|-49.41|-23.71|||Cochran-Mantel-Haenszel|||1.5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||-23.71|-49.41|<0.001
72625723|NCT01474109|144781028|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0||||0.649|TWO_SIDED|95.0|-0.2|0.1|||ANCOVA|||||0.1|-0.2|0.649
72625724|NCT01474109|144781029|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1||||0.456|TWO_SIDED|95.0|-0.2|0.1|||ANCOVA|||||0.1|-0.2|0.456
72531017|NCT00174460|144591084|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.688|STANDARD_ERROR_OF_MEAN|0.1519|<|0.001|TWO_SIDED|95.0|0.382|0.994|||Mixed models analysis|Results from repeated measures mixed models analysis adjusted for baseline height SDS, visit, visit\*treatment and target height SDS.||Treatment difference Month 24||0.994|0.382|<0.001
72531018|NCT00174460|144591086|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.585|STANDARD_ERROR_OF_MEAN|0.3859|<|0.001|TWO_SIDED|95.0|3.806|5.363|||Mixed models analysis|Results from repeated measure mixed models analysis adjusted for baseline height, sex, age, visit, visit\*treatment and target height SDS.||Treatment difference Month 12||5.363|3.806|<0.001
72572078|NCT02912650|144671813|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-3.95||||0.086|TWO_SIDED|95.0|-8.45|0.56|||Cochran-Mantel-Haenszel|||1.5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||0.56|-8.45|0.086
72572079|NCT02912650|144671813|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-3.71||||0.112|TWO_SIDED|95.0|-8.28|0.86|||Cochran-Mantel-Haenszel|||1.5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||0.86|-8.28|0.112
72572080|NCT02912650|144671813|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-32.52|||<|0.001|TWO_SIDED|95.0|-45.86|-19.17|||Cochran-Mantel-Haenszel|||1.5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||-19.17|-45.86|<0.001
72572081|NCT02912650|144671813|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-32.88|||<|0.001|TWO_SIDED|95.0|-46.22|-19.55|||Cochran-Mantel-Haenszel|||1.5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||-19.55|-46.22|<0.001
72572082|NCT02912650|144671813|SUPERIORITY_OR_OTHER||CMH adjusted proportions|0.11||||0.968|TWO_SIDED|95.0|-5.2|5.42|||Cochran-Mantel-Haenszel|||1.5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||5.42|-5.20|0.968
72572083|NCT02912650|144671813|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-47.88|||<|0.001|TWO_SIDED|95.0|-61.18|-34.58|||Cochran-Mantel-Haenszel|||2 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||-34.58|-61.18|<0.001
72625725|NCT01474109|144781029|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1||||0.44|TWO_SIDED|95.0|-0.2|0.1|||ANCOVA|||||0.1|-0.2|0.440
72625726|NCT01474109|144781030|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1||||0.464|TWO_SIDED|95.0|-0.3|0.1|||ANCOVA|||||0.1|-0.3|0.464
72625727|NCT01474109|144781030|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1||||0.342|TWO_SIDED|95.0|-0.3|0.1|||ANCOVA|||||0.1|-0.3|0.342
72625728|NCT02589938|144781031|SUPERIORITY|Repeated measures analysis of covariance (RMANCOVA) models were constructed to assess differences in each outcome adjusting for baseline outcome value, group, time, and group by time interaction assuming an unstructured covariance. The primary objective was assessed using a linear contrast of group effect at 4 weeks||||||0.0167|||||||ANCOVA|||The primary endpoint was to determine whether true acupuncture (TA) was more effective than sham acupuncture (SA) or standard oral hygiene (SOH) at treating xerostomia as assessed by the xerostomia questionnaire (XQ) at Week 4. The study was powered to detect a difference of 10 points with an assumed standard deviation (SD)=16 between each pair of groups on XQ.This assumed a t-test with a two-sided significance level of 0·0133 and 84% power with 20% dropout.||||0.0167
72625729|NCT02521285|144781034|SUPERIORITY|||||||0.343|||||||t-test, 2 sided|||||||0.343
72531019|NCT00174460|144591086|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.563|STANDARD_ERROR_OF_MEAN|0.708|<|0.001|TWO_SIDED|95.0|2.134|4.992|||Mixed models analysis|Results from repeated measure mixed models analysis adjusted for baseline height, sex, age, visit, visit\*treatment and target height SDS.||Treatment difference Month 24||4.992|2.134|<0.001
72531020|NCT04051320|144591097|SUPERIORITY||F statistic|2.164||||0.16|TWO_SIDED||||||repeated measures ANOVA|||||||0.160
72531021|NCT04051320|144591098|SUPERIORITY||F statistic|1.74||||0.1922|TWO_SIDED||||||ANOVA|||||||0.1922
72531022|NCT04051320|144591099|SUPERIORITY||F statistic|0.837||||0.368|TWO_SIDED||||||ANOVA|||||||0.368
72531023|NCT04051320|144591100|SUPERIORITY||F statistic|0.23||||0.881|TWO_SIDED||||||ANOVA|||||||0.881
72531024|NCT04051320|144591101|SUPERIORITY||F statistic|16.541||||0.000723|TWO_SIDED||||||ANOVA|||||||0.000723
72531025|NCT04051320|144591102|SUPERIORITY||F statistic|0.072||||0.791|TWO_SIDED||||||ANOVA|||||||0.791
72531026|NCT04051320|144591103|SUPERIORITY||F statistic|4.952||||0.0372|TWO_SIDED||||||ANOVA|||||||0.0372
72531027|NCT04051320|144591104|SUPERIORITY||F statistic|3.258||||0.0861|TWO_SIDED||||||ANOVA|||||||0.0861
72531028|NCT04051320|144591105|SUPERIORITY||F statistic|2.37||||0.139|TWO_SIDED||||||ANOVA|||||||0.139
72531029|NCT04051320|144591106|SUPERIORITY||F statistic|1.484||||0.237|TWO_SIDED||||||ANOVA|||||||0.237
72531030|NCT04051320|144591107|SUPERIORITY||F statistic|0.013||||0.91|TWO_SIDED||||||ANOVA|||||||0.910
72531031|NCT04051320|144591108|SUPERIORITY||F statistic|4.609||||0.0449|TWO_SIDED||||||ANOVA|||||||0.0449
72625730|NCT02521285|144781034|SUPERIORITY|||||||0.149|||||||t-test, 2 sided|||||||0.149
72531032|NCT04051320|144591109|SUPERIORITY|||||||0.322|||||||Pearson's Correlation Coefficient|||||||0.322
72531033|NCT04051320|144591109|SUPERIORITY|||||||0.772|||||||Pearson's Correlation Coefficient|||||||0.772
72531034|NCT04051320|144591110|SUPERIORITY||Pearson's r|-0.568314||||0.068|TWO_SIDED||||||Pearson correlation|||||||0.068
72531035|NCT04051320|144591110|SUPERIORITY||Pearson's r|-0.082904||||0.8759289|TWO_SIDED||||||Pearson correlation|||||||0.8759289
72531036|NCT04051320|144591111|SUPERIORITY||Pearson's r|-0.1275539||||0.70859639|TWO_SIDED||||||Pearson correlation|||||||0.70859639
72531037|NCT04051320|144591111|SUPERIORITY||Pearson's r|0.49225646||||0.2617744|TWO_SIDED||||||Pearson correlation|||||||0.2617744
72531038|NCT04051320|144591112|SUPERIORITY|||||||0.568|||||||Pearson's Correlation Coefficient|||||||0.568
72531039|NCT04051320|144591112|SUPERIORITY|||||||0.944|||||||Pearson's Correlation Coefficient|||||||0.944
72531040|NCT04051320|144591113|SUPERIORITY|||||||0.103|||||||Pearson's Correlation Coefficient|||||||0.103
72531041|NCT01632345|144591114|SUPERIORITY_OR_OTHER||Difference (Doravirine - Efavirenz)|6.7|||||TWO_SIDED|95.0|-9.0|22.4|||||A negative value would be considered as favoring doravirine over efavirenz.|||22.4|-9.0|
72531042|NCT01632345|144591114|SUPERIORITY_OR_OTHER||Difference (Doravirine - Efavirenz)|9.7|||||TWO_SIDED|95.0|-4.6|24.9|||||A negative value would be considered as favoring doravirine over efavirenz.|||24.9|-4.6|
72531043|NCT01632345|144591114|SUPERIORITY_OR_OTHER||Difference (Doravirine - Efavirenz)|-11.9|||||TWO_SIDED|95.0|-27.9|6.3|||||A negative value would be considered as favoring doravirine over efavirenz.|||6.3|-27.9|
72531044|NCT01632345|144591114|SUPERIORITY_OR_OTHER||Difference (Doravirine - Efavirenz)|2.0|||||TWO_SIDED|95.0|-14.5|18.4|||||A negative value would be considered as favoring doravirine over efavirenz.|||18.4|-14.5|
72531045|NCT01632345|144591115|SUPERIORITY_OR_OTHER||Difference (Doravirine - Efavirenz)|-2.3|||||TWO_SIDED|95.0|-13.7|8.8|||||A negative value would be considered as favoring doravirine over efavirenz.|||8.8|-13.7|
72531046|NCT01632345|144591115|SUPERIORITY_OR_OTHER||Difference (Doravirine - Efavirenz)|2.2|||||TWO_SIDED|95.0|-9.9|14.7|||||A negative value would be considered as favoring doravirine over efavirenz.|||14.7|-9.9|
72531047|NCT01632345|144591115|SUPERIORITY_OR_OTHER||Difference (Doravirine - Efavirenz)|-2.4|||||TWO_SIDED|95.0|-13.8|8.2|||||A negative value would be considered as favoring doravirine over efavirenz.|||8.2|-13.8|
72531048|NCT01632345|144591115|SUPERIORITY_OR_OTHER||Difference (Doravirine - Efavirenz)|-4.8|||||TWO_SIDED|95.0|-15.9|4.1|||||A negative value would be considered as favoring doravirine over efavirenz.|||4.1|-15.9|
72531049|NCT01632345|144591116|SUPERIORITY_OR_OTHER||Difference|-10.2|||||TWO_SIDED|95.0|-20.9|0.5|||||A negative value would be considered as favoring doravirine over efavirenz.|||0.5|-20.9|
72531050|NCT01632345|144591117|SUPERIORITY_OR_OTHER||Difference (Doravirine - Efavirenz)|-20.4||||0.002|TWO_SIDED|95.0|-32.4|-7.8||Superiority analysis|Miettinen and Nurminen method||A negative value would be considered as favoring doravirine over efavirenz.|||-7.8|-32.4|0.002
72531051|NCT01632345|144591118|SUPERIORITY_OR_OTHER||Difference (Doravirine - Efavirenz)|-20.4||||0.002|TWO_SIDED|95.0|-32.6|-7.5||Superiority analysis|Miettinen and Nurminen method||A negative value would be considered as favoring doravirine over efavirenz.|||-7.5|-32.6|0.002
72531052|NCT01632345|144591119|SUPERIORITY_OR_OTHER||Difference in % response|15.7|||||TWO_SIDED|95.0|-4.1|34.4|||||A positive value would be considered as favoring doravirine over efavirenz.|||34.4|-4.1|
72531053|NCT01632345|144591119|SUPERIORITY_OR_OTHER||Difference in % response|10.0|||||TWO_SIDED|95.0|-9.6|29.1|||||A positive value would be considered as favoring doravirine over efavirenz.|||29.1|-9.6|
72531054|NCT01632345|144591119|SUPERIORITY_OR_OTHER||Difference in % response|6.6|||||TWO_SIDED|95.0|-13.2|26.0|||||A positive value would be considered as favoring doravirine over efavirenz.|||26.0|-13.2|
72531055|NCT01632345|144591119|SUPERIORITY_OR_OTHER||Difference in % response|15.9|||||TWO_SIDED|95.0|-3.4|34.4|||||A positive value would be considered as favoring doravirine over efavirenz.|||34.4|-3.4|
72531056|NCT01632345|144591120|SUPERIORITY_OR_OTHER||Difference in % response|-0.5|||||TWO_SIDED|95.0|-13.2|11.2|||||A positive value would be considered as favoring doravirine over efavirenz.|||11.2|-13.2|
72531057|NCT01632345|144591121|SUPERIORITY_OR_OTHER||Difference in % response|-1.9|||||TWO_SIDED|95.0|-12.9|9.2|||||A positive value would be considered as favoring doravirine over efavirenz.|||9.2|-12.9|
72625731|NCT02521285|144781035|SUPERIORITY|||||||0.878|||||||t-test, 2 sided|||||||0.878
72625732|NCT02521285|144781036|SUPERIORITY|||||||0.382|||||||t-test, 2 sided|||||||0.382
72625733|NCT02521285|144781036|SUPERIORITY|||||||0.05|||||||t-test, 2 sided|||||||0.05
72625734|NCT02521285|144781037|SUPERIORITY|||||||0.53|||||||t-test, 2 sided|||||||0.53
72625735|NCT02521285|144781037|SUPERIORITY|||||||1|||||||t-test, 2 sided|||||||1
72625736|NCT02521285|144781038|SUPERIORITY|||||||0.234|||||||t-test, 2 sided|||||||0.234
72625737|NCT02521285|144781038|SUPERIORITY|||||||0.442|||||||t-test, 2 sided|||||||0.442
72531058|NCT01632345|144591122|SUPERIORITY_OR_OTHER||Difference in % response|-0.8|||||TWO_SIDED|95.0|-12.4|10.7|||||A positive value would be considered as favoring doravirine over efavirenz.|||10.7|-12.4|
72531059|NCT01632345|144591123|SUPERIORITY_OR_OTHER||Difference in % response|4.5|||||TWO_SIDED|95.0|-12.5|21.5|||||A positive value would be considered as favoring doravirine over efavirenz.|||21.5|-12.5|
72531060|NCT01632345|144591123|SUPERIORITY_OR_OTHER||Difference in % response|2.8|||||TWO_SIDED|95.0|-13.9|19.8|||||A positive value would be considered as favoring doravirine over efavirenz.|||19.8|-13.9|
72531061|NCT01632345|144591123|SUPERIORITY_OR_OTHER||Difference in % response|12.2|||||TWO_SIDED|95.0|-2.5|28.0|||||A positive value would be considered as favoring doravirine over efavirenz.|||28.0|-2.5|
72531062|NCT01632345|144591123|SUPERIORITY_OR_OTHER||Difference in % response|9.5|||||TWO_SIDED|95.0|-6.2|25.7|||||A positive value would be considered as favoring doravirine over efavirenz.|||25.7|-6.2|
72531063|NCT01632345|144591124|SUPERIORITY_OR_OTHER||Difference in % response|2.7||||||95.0|-6.1|11.7|||||A positive value would be considered as favoring doravirine over efavirenz.|||11.7|-6.1|
72531064|NCT01632345|144591125|SUPERIORITY_OR_OTHER||Difference in % response|0.1|||||TWO_SIDED|95.0|-9.7|9.9|||||A positive value would be considered as favoring doravirine over efavirenz.|||9.9|-9.7|
72531065|NCT01632345|144591126|SUPERIORITY_OR_OTHER||Difference in % response|3.9|||||TWO_SIDED|95.0|-7.3|15.0|||||A positive value would be considered as favoring doravirine over efavirenz.|||15.0|-7.3|
72531066|NCT01632345|144591127|SUPERIORITY_OR_OTHER||Difference in CD4 change|33.0|||||TWO_SIDED|95.0|-28.1|94.0|||||A positive value would be considered as favoring doravirine over efavirenz.|||94.0|-28.1|
72531067|NCT01632345|144591127|SUPERIORITY_OR_OTHER||Difference in CD4 change|-8.3|||||TWO_SIDED|95.0|-68.5|51.9|||||A positive value would be considered as favoring doravirine over efavirenz.|||51.9|-68.5|
72531068|NCT01632345|144591127|SUPERIORITY_OR_OTHER||Difference in CD4 change|12.5|||||TWO_SIDED|95.0|-44.6|69.5|||||A positive value would be considered as favoring doravirine over efavirenz.|||69.5|-44.6|
72531069|NCT01632345|144591127|SUPERIORITY_OR_OTHER||Difference in CD4 change|19.6|||||TWO_SIDED|95.0|-45.1|84.2|||||A positive value would be considered as favoring doravirine over efavirenz.|||84.2|-45.1|
72531070|NCT01632345|144591128|SUPERIORITY_OR_OTHER||Difference in CD4 change|6.3|||||TWO_SIDED|95.0|-38.2|50.8|||||A positive value would be considered as favoring doravirine over efavirenz.|||50.8|-38.2|
72531071|NCT01632345|144591129|SUPERIORITY_OR_OTHER||Difference in CD4 change|-2.6|||||TWO_SIDED|95.0|-46.5|41.3|||||A positive value would be considered as favoring doravirine over efavirenz.|||41.3|-46.5|
72531072|NCT01632345|144591130|SUPERIORITY_OR_OTHER||Difference in CD4 change|-4.4|||||TWO_SIDED|95.0|-64.0|55.1|||||A positive value would be considered as favoring doravirine over efavirenz.|||55.1|-64.0|
72531073|NCT01632345|144591131|SUPERIORITY_OR_OTHER||Difference|-2.8|||||TWO_SIDED|95.0|-11.7|6.0|||||A negative value would be considered as favoring doravirine over efavirenz.|||6.0|-11.7|
72531074|NCT01632345|144591132|SUPERIORITY_OR_OTHER||Difference|-6.5|||||TWO_SIDED|95.0|-14.1|0.3|||||A negative value would be considered as favoring doravirine over efavirenz.|||0.3|-14.1|
72531075|NCT03547960|144591133|SUPERIORITY|||||||0.639|||||||Chi-squared|||||||0.639
72531076|NCT03547960|144591133|SUPERIORITY|||||||0.283|||||||Wilcoxon (Mann-Whitney)|||||||0.283
72531077|NCT03547960|144591135|SUPERIORITY|||||||0.564|||||||Wilcoxon (Mann-Whitney)|||||||0.564
72531078|NCT03370133|144591147|SUPERIORITY||Odds Ratio (OR)|99.869|||<|0.001|TWO_SIDED|95.0|34.02|293.175||P-values for the comparison of treatment groups (BKZ 320 mg Q4W vs PBO) were based on the CMH test from the general association.|Cochran-Mantel-Haenszel|||Odds ratio was calculated using stratified CMH (Cochran-Mantel-Haenszel) test with region and prior biologic exposure as stratification variables.||293.175|34.020|<0.001
72531079|NCT03370133|144591147|SUPERIORITY||Odds Ratio (OR)|6.056|||<|0.001|TWO_SIDED|95.0|3.874|9.466||P-values for the comparison of treatment groups (BKZ 320 mg Q4W vs Ustekinumab) were based on the CMH test from the general association.|Cochran-Mantel-Haenszel|||Odds ratio was calculated using stratified CMH (Cochran-Mantel-Haenszel) test with region and prior biologic exposure as stratification variables.||9.466|3.874|<0.001
72531080|NCT03370133|144591148|SUPERIORITY||Odds Ratio (OR)|118.762|||<|0.001|TWO_SIDED|95.0|36.701|384.307||P-values for the comparison of treatment groups (BKZ 320 mg Q4W vs PBO) were based on the CMH test from the general association.|Cochran-Mantel-Haenszel|||Odds ratio was calculated using stratified CMH (Cochran-Mantel-Haenszel) test with region and prior biologic exposure as stratification variables.||384.307|36.701|<0.001
72531081|NCT03370133|144591148|SUPERIORITY||Odds Ratio (OR)|4.809|||<|0.001|TWO_SIDED|95.0|3.096|7.47||P-values for the comparison of treatment groups (BKZ 320 mg Q4W vs Ustekinumab) were based on the CMH test from the general association.|Cochran-Mantel-Haenszel|||Odds ratio was calculated using stratified CMH (Cochran-Mantel-Haenszel) test with region and prior biologic exposure as stratification variables.||7.470|3.096|<0.001
72531082|NCT03370133|144591149|SUPERIORITY||Odds Ratio (OR)|25.59|||<|0.001|TWO_SIDED|95.0|9.063|72.253||P-values for the comparison of treatment groups (BKZ 320 mg Q4W vs PBO) were based on the CMH test from the general association.|Cochran-Mantel-Haenszel|||Odds ratio was calculated using stratified CMH test with region and prior biologic exposure as stratification variables. Logit method was used where CMH test not possible due to very low response.||72.253|9.063|<0.001
72531083|NCT03370133|144591150|SUPERIORITY||Odds Ratio (OR)|25.471|||<|0.001|TWO_SIDED|95.0|9.02|71.925||P-values for the comparison of treatment groups (BKZ 320 mg Q4W vs PBO) were based on the CMH test from the general association.|Cochran-Mantel-Haenszel|||Odds ratio was calculated using stratified CMH test with region and prior biologic exposure as stratification variables. Logit method was used where CMH test not possible due to very low response.||71.925|9.020|<0.001
72531084|NCT03370133|144591151|SUPERIORITY||Odds Ratio (OR)|123.02|||<|0.001|TWO_SIDED|95.0|29.394|514.862||P-values for the comparison of treatment groups (BKZ 320 mg Q4W vs PBO) were based on the CMH test from the general association.|Cochran-Mantel-Haenszel|||Odds ratio was calculated using stratified CMH test with region and prior biologic exposure as stratification variables. Logit method was used where CMH test not possible due to very low response.||514.862|29.394|<0.001
72531085|NCT03370133|144591151|SUPERIORITY||Odds Ratio (OR)|18.202|||<|0.001|TWO_SIDED|95.0|10.998|30.123||P-values for the comparison of treatment groups (BKZ 320 mg Q4W vs Ustekinumab) were based on the CMH test from the general association.|Cochran-Mantel-Haenszel|||Odds ratio was calculated using stratified CMH test with region and prior biologic exposure as stratification variables.||30.123|10.998|<0.001
72531086|NCT03370133|144591152|SUPERIORITY||Odds Ratio (OR)|16.258|||<|0.001|TWO_SIDED|95.0|7.356|35.931||P-values for the comparison of treatment groups (BKZ 320 mg Q4W vs PBO) were based on the CMH test from the general association.|Cochran-Mantel-Haenszel|||Odds ratio was calculated using stratified CMH test with region and prior biologic exposure as stratification variables. Logit method was used where CMH test not possible due to very low response.||35.931|7.356|<0.001
72531087|NCT03370133|144591153|SUPERIORITY||Odds Ratio (OR)|22.279|||<|0.001|TWO_SIDED|95.0|9.795|50.674||P-values for the comparison of treatment groups (BKZ 320 mg Q4W vs PBO) were based on the CMH test from the general association.|Cochran-Mantel-Haenszel|||Odds ratio was calculated using stratified CMH test with region and prior biologic exposure as stratification variables. Logit method was used where CMH test not possible due to very low response.||50.674|9.795|<0.001
72531088|NCT03370133|144591154|SUPERIORITY||Odds Ratio (OR)|23.049|||<|0.001|TWO_SIDED|95.0|10.201|52.077||P-values for the comparison of treatment groups (BKZ 320 mg Q4W vs PBO) were based on the CMH test from the general association.|Cochran-Mantel-Haenszel|||Odds ratio was calculated using stratified CMH test with region and prior biologic exposure as stratification variables. Logit method was used where CMH test not possible due to very low response.||52.077|10.201|<0.001
72531089|NCT03370133|144591155|SUPERIORITY||Odds Ratio (OR)|37.696|||<|0.001|TWO_SIDED|95.0|16.92|83.987||P-values for the comparison of treatment groups (BKZ 320 mg Q4W vs PBO) were based on the CMH test from the general association.|Cochran-Mantel-Haenszel|||Odds ratio was calculated using stratified CMH test with region and prior biologic exposure as stratification variables. Logit method was used where CMH test not possible due to very low response.||83.987|16.920|<0.001
72531090|NCT03370133|144591156|SUPERIORITY||Odds Ratio (OR)|8.047|||<|0.001|TWO_SIDED|95.0|5.107|12.679||P-values for the comparison of treatment groups (BKZ 320 mg Q4W vs Ustekinumab) were based on the CMH test from the general association.|Cochran-Mantel-Haenszel|||Odds ratio was calculated using stratified CMH test with region and prior biologic exposure as stratification variables.||12.679|5.107|<0.001
72531091|NCT03370133|144591157|SUPERIORITY||Odds Ratio (OR)|3.795|||<|0.001|TWO_SIDED|95.0|2.442|5.899||P-values for the comparison of treatment groups (BKZ 320 mg Q4W vs Ustekinumab) were based on the CMH test from the general association.|Cochran-Mantel-Haenszel|||Odds ratio was calculated using stratified CMH test with region and prior biologic exposure as stratification variables.||5.899|2.442|<0.001
72531092|NCT03370133|144591158|SUPERIORITY||Odds Ratio (OR)|4.379|||<|0.001|TWO_SIDED|95.0|2.85|6.73||P-values for the comparison of treatment groups (BKZ 320 mg Q4W vs Ustekinumab) were based on the CMH test from the general association.|Cochran-Mantel-Haenszel|||Odds ratio was calculated using stratified CMH test with region and prior biologic exposure as stratification variables.||6.730|2.850|<0.001
72531093|NCT03370133|144591159|SUPERIORITY||Odds Ratio (OR)|2.412|||<|0.001|TWO_SIDED|95.0|1.573|3.699||P-values for the comparison of treatment groups (BKZ 320 mg Q4W vs Ustekinumab) were based on the CMH test from the general association.|Cochran-Mantel-Haenszel|||Odds ratio was calculated using stratified CMH test with region and prior biologic exposure as stratification variables.||3.699|1.573|<0.001
72531094|NCT03524664|144591166|SUPERIORITY|||||||0.523||||||The threshold for statistical significance was p = 0.05.|ANOVA|F(1,71) = 0.411, p =.523||Repeated measures ANOVA||||.523
72531095|NCT03524664|144591167|SUPERIORITY|||||||0.173||||||The threshold for statistical significance was p = 0.05.|ANOVA|F(1,71)=1.89, p=.173||Repeated measures ANOVA||||.173
72531096|NCT03524664|144591168|SUPERIORITY|||||||0.14||||||The threshold for statistical significance was p = 0.05.|ANOVA|F(1,71)=2.23, p=.140||Outcome data analyzed for those with complete data at both timepoints.||||.140
72531097|NCT03524664|144591169|SUPERIORITY|||||||0.845||||||The threshold for statistical significance was p = 0.05.|ANOVA|F(1,70)=.039, p=0.845||Outcome data analyzed for those with complete data at both timepoints.||||0.845
72531098|NCT03524664|144591170|SUPERIORITY|||||||0.147||||||The threshold for statistical significance was p = 0.05.|ANOVA|F(1,70)=2.147, p=.147||Outcome data analyzed for those with complete data at both timepoints.||||.147
72531099|NCT03524664|144591171|SUPERIORITY|||||||0.429||||||The threshold for statistical significance was p = 0.05.|ANOVA|F(1,70)=.633, p=.429||Outcome data analyzed for those with complete data at both timepoints.||||.429
72531100|NCT03524664|144591172|SUPERIORITY|||||||0.208||||||The threshold for statistical significance was p = 0.05.|ANOVA|F(1,70)=1.618, p=.208||Outcome data analyzed for those with complete data at both timepoints.||||.208
72531101|NCT03524664|144591173|SUPERIORITY|||||||0.3||||||The threshold for statistical significance was p = 0.05.|ANOVA|F(1,71)=1.09, p=.300||Outcome data analyzed for those with complete data at both timepoints.||||.300
72531102|NCT03524664|144591174|SUPERIORITY|||||||0.099||||||The threshold for statistical significance was p = 0.05.|ANOVA|F(1,71)=2.79, p=.099||Outcome data analyzed for those with complete data at both timepoints.||||.099
72531103|NCT03524664|144591175|SUPERIORITY|||||||0.105||||||The threshold for statistical significance was p = 0.05.|ANOVA|F(1,71)=2.70, p=.105||Outcome data analyzed for those with complete data at both timepoints.||||.105
72531104|NCT03524664|144591176|SUPERIORITY|||||||0.699||||||The threshold for statistical significance was p = 0.05.|ANOVA|F(1,71)=0.15, p=.699||Repeated measures ANOVA||||.699
72531105|NCT03524664|144591177|SUPERIORITY|||||||0.945||||||The threshold for statistical significance was p = 0.05.|ANOVA|F(1,71)=0.005, p=.945||Repeated measures ANOVA||||.945
72531106|NCT03524664|144591178|SUPERIORITY|||||||0.767||||||The threshold for statistical significance was p = 0.05.|ANOVA|F(1,71)=0.088, p=.767||Repeated measures ANOVA||||.767
72531107|NCT03524664|144591179|SUPERIORITY|||||||0.682||||||The threshold for statistical significance was p = 0.05.|ANOVA|F(1,71)=.0.17, p=.682||Repeated measures ANOVA||||.682
72531108|NCT03524664|144591180|SUPERIORITY|||||||0.96||||||The threshold for statistical significance was p = 0.05.|ANOVA|F(1,42)=0.003, p=.960||Repeated measures ANOVA||||.960
72531109|NCT03524664|144591181|SUPERIORITY|||||||0.643||||||The threshold for statistical significance was p = 0.05.|ANOVA|F(1,42)=0.218, p=.643||Repeated measures ANOVA||||.643
72531110|NCT03524664|144591182|SUPERIORITY|||||||0.118||||||The threshold for statistical significance was p = 0.05.|ANOVA|Time X Group F(2,90)=2.19, p.118||Repeated measures ANOVA||||.118
72531111|NCT03524664|144591183|SUPERIORITY|||||||0.8||||||The threshold for statistical significance was p = 0.05.|ANOVA|Time x Group F(2,90)=.223, p=.800||Repeated measures ANOVA||||.800
72531112|NCT03524664|144591184|SUPERIORITY|||||||0.863||||||The threshold for statistical significance was p = 0.05.|ANOVA|Group x Time F(2,92)=0.148, p=.863||Repeated measures ANOVA||||.863
72531113|NCT00684073|144591193|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.42||||0.13||95.0||||p-value adjusted for treatment only|ANCOVA||Difference between treatments (Suboxone minus Subutex)estimated by ANCOVA = 0.42.|||||0.130
72531114|NCT00620815|144591196|NON_INFERIORITY_OR_EQUIVALENCE|To show statistical equivalence was, confidence intervals (CIs) of all 3 pair wise ratios of the GMAs were inspected.|Group Mean Ratio|1.13|||||TWO_SIDED|96.67|1.02|1.25||P-values were not calculated for the equivalence tests due to lack of appropriate statistical software|ANOVA|||(On day 1) Null hypothesis representing non-equivalence was rejected if the two-sided (1-2α)\*100% CI on one GMA ratio is completely within the equivalence range \[0.5, 2.0\].||1.25|1.02|
72531115|NCT00620815|144591196|NON_INFERIORITY_OR_EQUIVALENCE|To show statistical equivalence was, confidence intervals (CIs) of all 3 pair wise ratios of the GMAs were inspected.|Geometric Mean Ratios|1.01|||||TWO_SIDED|96.67|0.91|1.12||P-values were not calculated for the equivalence tests due to lack of appropriate statistical software|ANOVA|||(On day 1) Null hypothesis representing non-equivalence was rejected if the two-sided (1-2α)\*100% CI on one GMA ratio is completely within the equivalence range \[0.5, 2.0\].||1.12|0.91|
72531116|NCT00620815|144591196|NON_INFERIORITY_OR_EQUIVALENCE|To show statistical equivalence was, confidence intervals (CIs) of all 3 pair wise ratios of the GMAs were inspected.|Geometric Mean Ratio|0.89|||||TWO_SIDED|96.67|0.8|0.99||P-values were not calculated for the equivalence tests due to lack of appropriate statistical software|ANOVA|||(On day 1)Null hypothesis representing non-equivalence was rejected if the two-sided (1-2α)\*100% CI on one GMA ratio is completely within the equivalence range \[0.5, 2.0\].||0.99|0.80|
72531117|NCT00620815|144591196|NON_INFERIORITY_OR_EQUIVALENCE|To show statistical equivalence was, confidence intervals (CIs) of all 3 pair wise ratios of the GMAs were inspected.|Geometric Mean Ratios|1.19|||||TWO_SIDED|96.67|0.74|1.93||P-values were not calculated for the equivalence tests due to lack of appropriate statistical software|ANOVA|||(On day 22) Null hypothesis representing non-equivalence was rejected if the two-sided (1-2α)\*100% CI on one GMA ratio is completely within the equivalence range \[0.5, 2.0\].||1.93|0.74|
72531118|NCT00620815|144591196|NON_INFERIORITY_OR_EQUIVALENCE|To show statistical equivalence was, confidence intervals (CIs) of all 3 pair wise ratios of the GMAs were inspected.|Geometric Mean Ratios|0.85|||||TWO_SIDED|96.67|0.52|1.38||P-values were not calculated for the equivalence tests due to lack of appropriate statistical software|ANOVA|||(On day 22) Null hypothesis representing non-equivalence was rejected if the two-sided (1-2α)\*100% CI on one GMA ratio is completely within the equivalence range \[0.5, 2.0\].||1.38|0.52|
72531119|NCT00620815|144591196|NON_INFERIORITY_OR_EQUIVALENCE|To show statistical equivalence was, confidence intervals (CIs) of all 3 pair wise ratios of the GMAs were inspected.|Geometric Mean Ratios|0.71|||||TWO_SIDED|96.67|0.44|1.15||P-values were not calculated for the equivalence tests due to lack of appropriate statistical software|ANOVA|||(On day 22) Null hypothesis representing non-equivalence was rejected if the two-sided (1-2α)\*100% CI on one GMA ratio is completely within the equivalence range \[0.5, 2.0\].||1.15|0.44|
72531120|NCT00620815|144591196|NON_INFERIORITY_OR_EQUIVALENCE|To show statistical equivalence was, confidence intervals (CIs) of all 3 pair wise ratios of the GMAs were inspected.|Geometric Mean Ratios|1.14|||||TWO_SIDED|96.67|1.01|1.3||P-values were not calculated for the equivalence tests due to lack of appropriate statistical software|ANOVA|||(On day 43) Null hypothesis representing non-equivalence was rejected if the two-sided (1-2α)\*100% CI on one GMA ratio is completely within the equivalence range \[0.5, 2.0\].||1.30|1.01|
72531121|NCT00620815|144591196|NON_INFERIORITY_OR_EQUIVALENCE|To show statistical equivalence was, confidence intervals (CIs) of all 3 pair wise ratios of the GMAs were inspected.|Geometric Mean Ratios|1.05|||||TWO_SIDED|96.67|0.93|1.19||P-values were not calculated for the equivalence tests due to lack of appropriate statistical software|ANOVA|||(On day 43) Null hypothesis representing non-equivalence was rejected if the two-sided (1-2α)\*100% CI on one GMA ratio is completely within the equivalence range \[0.5, 2.0\].||1.19|0.93|
72531122|NCT00620815|144591196|NON_INFERIORITY_OR_EQUIVALENCE|To show statistical equivalence was, confidence intervals (CIs) of all 3 pair wise ratios of the GMAs were inspected.|Geometric Mean Ratios|0.92|||||TWO_SIDED|96.67|0.81|1.04||P-values were not calculated for the equivalence tests due to lack of appropriate statistical software|ANOVA|||(On day 43) Null hypothesis representing non-equivalence was rejected if the two-sided (1-2α)\*100% CI on one GMA ratio is completely within the equivalence range \[0.5, 2.0\].||1.04|0.81|
72531123|NCT00877929|144591210|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.1||||0.0001||95.0|-7.9|-4.2|||ANCOVA|Included effects of treatment, week and treatment-by-week interaction with covariate of baseline blood pressure and baseline-week interaction.||||-4.2|-7.9|0.0001
72531124|NCT00877929|144591211|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.1||||0.0001||95.0|-8.9|-5.4|||ANCOVA|Included effects of treatment, week and treatment-by-week interaction with covariate of baseline blood pressure and baseline-week interaction.||||-5.4|-8.9|0.0001
72531125|NCT00877929|144591212|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.6||||0.0001||95.0|-8.3|-4.9|||ANCOVA|Included effects of treatment, week and treatment-by-week interaction with covariate of baseline blood pressure and baseline-week interaction.||||-4.9|-8.3|0.0001
72531126|NCT00877929|144591213|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.1||||0.0001||95.0|-7.9|-4.3|||ANCOVA|Included effects of treatment, week and treatment-by-week interaction with covariate of baseline blood pressure and baseline-week interaction.||||-4.3|-7.9|0.0001
72531127|NCT00877929|144591214|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.9||||0.0001||95.0|-6.6|-3.2|||ANCOVA|Included effects of treatment, week and treatment-by-week interaction with covariate of baseline blood pressure and baseline-week interaction.||||-3.2|-6.6|0.0001
72531128|NCT00689728|144591261|SUPERIORITY_OR_OTHER|||||||0.178||95.0|||||Fisher Exact|||||||0.178
72531129|NCT00689728|144591261|SUPERIORITY_OR_OTHER|||||||0.116||95.0|||||Fisher Exact|||||||0.116
72531130|NCT00689728|144591263|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.873||||0.062||95.0||||p-value represents change from baseline at 16 weeks for LY2127399 30 mg. vs. placebo in Physical Health Component scores.|ANCOVA|||||||0.062
72531131|NCT00689728|144591263|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.427||||0.052||95.0||||p-value represents change from baseline at 16 weeks for LY2127399 80 mg. vs. placebo in Physical Health Component scores.|ANCOVA|||||||0.052
72531132|NCT00689728|144591263|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.72||||0.655||95.0||||p-value represents change from baseline at 16 weeks for LY2127399 30 mg. vs. placebo in Mental Health Component scores.|ANCOVA|||||||0.655
72625738|NCT02521285|144781039|SUPERIORITY|||||||0.645|||||||t-test, 2 sided|||||||0.645
72531133|NCT00689728|144591263|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.264||||0.173||95.0||||p-value represents change from baseline at 16 weeks for LY2127399 80 mg. vs. placebo in Mental Health Component scores.|ANCOVA|||||||0.173
72531134|NCT00689728|144591264|SUPERIORITY_OR_OTHER|||||||0.281||95.0|||||Fisher Exact|||||||0.281
72531135|NCT00689728|144591264|SUPERIORITY_OR_OTHER|||||||0.218||95.0|||||Fisher Exact|||||||0.218
72531136|NCT00689728|144591265|SUPERIORITY_OR_OTHER|||||||0.5||95.0|||||Fisher Exact|||||||0.500
72531137|NCT00689728|144591265|SUPERIORITY_OR_OTHER|||||||0.444||95.0|||||Fisher Exact|||||||0.444
72531138|NCT00689728|144591266|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.5||||0.337||95.0|||||ANCOVA|||||||0.337
72531139|NCT00689728|144591266|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.6||||0.038||95.0|||||ANCOVA|||||||0.038
72531140|NCT00689728|144591267|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.7||||0.403||95.0|||||ANCOVA|||||||0.403
72531141|NCT00689728|144591267|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.3||||0.006||95.0|||||ANCOVA|||||||0.006
72531142|NCT00689728|144591268|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.2||||0.168||95.0|||||ANCOVA|||||||0.168
72531143|NCT00689728|144591268|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.3||||0.075||95.0|||||ANCOVA|||||||0.075
72531144|NCT00689728|144591269|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.3||||0.157||95.0|||||ANCOVA|||||||0.157
72531145|NCT00689728|144591269|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-25.6||||0.025||95.0|||||ANCOVA|||||||0.025
72531146|NCT00689728|144591270|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.4||||0.11||95.0|||||ANCOVA|||||||0.110
72531147|NCT00689728|144591270|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.1||||0.147||95.0|||||ANCOVA|||||||0.147
72531148|NCT00689728|144591271|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.172||||0.969||95.0|||||ANCOVA|||||||0.969
72531149|NCT00689728|144591271|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.28||||0.452||95.0|||||ANCOVA|||||||0.452
72531150|NCT00689728|144591272|SUPERIORITY_OR_OTHER|||||||0.554||95.0|||||ANCOVA|||||||0.554
72531151|NCT00689728|144591272|SUPERIORITY_OR_OTHER|||||||0.92||95.0|||||ANCOVA|||||||0.920
72531152|NCT00689728|144591273|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.912||||0.1||95.0|||||ANCOVA|||||||0.100
72531153|NCT00689728|144591273|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.322||||0.005||95.0|||||ANCOVA|||||||0.005
72531154|NCT00689728|144591274|SUPERIORITY_OR_OTHER|||||||0.022||95.0||||p-value represents comparison of LY2127399-30 mg dose versus placebo for the 3 levels of EULAR response (good response, moderate response, no response).|Fisher Exact|||||||0.022
72531155|NCT00689728|144591274|SUPERIORITY_OR_OTHER|||||||0.016||95.0||||p-value represents comparison of LY2127399-80 mg dose versus placebo for the 3 levels of EULAR response (good response, moderate response, no response).|Fisher Exact|||||||0.016
72531156|NCT00689728|144591275|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.6||||0.818||95.0|||||ANCOVA|||||||0.818
72531157|NCT00689728|144591275|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.7||||0.066||95.0|||||ANCOVA|||||||0.066
72531158|NCT00689728|144591276|SUPERIORITY_OR_OTHER|||||||0.01||95.0|||||ANCOVA|||||||0.010
72531159|NCT00689728|144591276|SUPERIORITY_OR_OTHER|||||||0.056||95.0|||||ANCOVA|||||||0.056
72531160|NCT00689728|144591277|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||ANCOVA|||||||0.001
72531161|NCT00689728|144591277|SUPERIORITY_OR_OTHER|||||||0.015||95.0|||||ANCOVA|||||||0.015
72531162|NCT00689728|144591278|SUPERIORITY_OR_OTHER|||||||0.146||95.0||||p-value is for Immunoglobulin G change at week 16 (LOCF)|ANCOVA|||||||0.146
72531163|NCT00689728|144591278|SUPERIORITY_OR_OTHER|||||||0.125||95.0||||p-value is for Immunoglobulin G change at week 16 (LOCF)|ANCOVA|||||||0.125
72531164|NCT00689728|144591278|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value is for Immunoglobulin M change at week 16 (LOCF)|ANCOVA|||||||<0.001
72531165|NCT00689728|144591278|SUPERIORITY_OR_OTHER|||||||0.005||95.0||||p-value is for Immunoglobulin M change at week 16 (LOCF)|ANCOVA|||||||0.005
72531166|NCT00689728|144591278|SUPERIORITY_OR_OTHER|||||||0.115||95.0||||p-value is for Immunoglobulin A change at week 16 (LOCF)|ANCOVA|||||||0.115
72531167|NCT00689728|144591278|SUPERIORITY_OR_OTHER|||||||0.019||95.0||||p-value is for Immunoglobulin A change at week 16 (LOCF)|ANCOVA|||||||0.019
72531168|NCT04047342|144591281|SUPERIORITY||Odds Ratio (OR)|0.97||||0.828|TWO_SIDED|95.0|0.72|1.3||We used an a priori threshold of p \< .05.|Regression, Logistic|||||1.30|0.72|.828
72531169|NCT00280059|144591314|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority margin for the proportion of seizure free participants set at 10%; non-inferiority declared if the lower bound of the 95% confidence interval (CI) of the difference in seizure-free proportion between pregabalin and lamotrigine was no more than 10% in favor of lamotrigine, but 0 was contained within the lower bound of the CI. Interpretation of superiority required lower bound of CI did not contain 0 in favor of pregabalin.|Mean Difference (Final Values)|-0.16|||||TWO_SIDED|95.0|-0.24|-0.09|||Gart and Nam: correction of skewness||95% confidence interval for the true difference in proportions, as well as a one-sided test at α=0.025; confidence interval adjusted for centers clustered within a geographical region, with upper and lower confidence limits.|Analysis of the binary response variable for 6 consecutive months seizure freedom analyzed by comparing the proportions of favorable responders between the two treatment groups after stratifying by clusters and correcting for skewness (Gart and Nam, 1990). Percentage can be obtained by multiplying proportion by 100.||-0.09|-0.24|
72531170|NCT00280059|144591315|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.74||||0.0034|TWO_SIDED|95.0|0.6|0.9||Nominal value for 2-sided test calculated using Cox proportional hazards model, adjusted for geographic regions.|Regression, Cox|||Risk ratio=hazard ratio estimated from the Cox proportional hazards model for assessing a treatment difference, risk ratio \> 1 is in favor of pregabalin. The 95% confidence interval is for the true risk ratio.||0.90|0.60|0.0034
72531171|NCT00280059|144591316|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|1.06||||0.8047|TWO_SIDED|95.0|0.65|1.74||Nominal value for 2-sided test calculated using Cox proportional hazards model adjusted for geographical cluster.|Cox proportional hazards model|||Risk ratio=hazard ratio estimated from the Cox proportional hazards model for assessing a treatment difference, risk ratio \< 1 is in favor of pregabalin. The 95% confidence interval is for the true risk ratio.||1.74|0.65|0.8047
72625739|NCT02521285|144781039|SUPERIORITY|||||||0.878|||||||t-test, 2 sided|||||||0.878
72625740|NCT02521285|144781047|SUPERIORITY|||||||0.755|||||||t-test, 2 sided|||||||0.755
72531172|NCT00280059|144591317|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|1.19||||0.2537|TWO_SIDED|95.0|0.88|1.6||Nominal value for 2-sided test calculated using Cox proportional hazards model adjusted for geographical cluster.|Cox proportional hazards model|||Risk ratio=hazard ratio estimated from the Cox proportional hazards model for assessing a treatment difference, risk ratio \< 1 is in favor of pregabalin. The 95% confidence interval is for the true risk ratio.||1.60|0.88|0.2537
72531173|NCT00280059|144591318|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|6.52||||0.0025|TWO_SIDED|95.0|1.93|22.04||Nominal value for 2-sided test calculated using Cox proportional hazards model adjusted for geographical cluster.|Cox proportional hazards model|||Risk ratio=hazard ratio estimated from the Cox proportional hazards model for assessing a treatment difference, risk ratio \< 1 is in favor of pregabalin. The 95% confidence interval is for the true risk ratio.||22.04|1.93|0.0025
72531174|NCT00280059|144591319|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|1.36||||0.0744|TWO_SIDED|95.0|0.97|1.91||Nominal value for 2-sided test calculated using Cox proportional hazards model adjusted for geographical cluster.|Cox proportional hazards model|||Risk ratio=hazard ratio estimated from the Cox proportional hazards model for assessing a treatment difference, risk ratio \< 1 is in favor of pregabalin. The 95% confidence interval is for the true risk ratio.||1.91|0.97|0.0744
72531175|NCT00280059|144591320|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|1.47||||0.0003|TWO_SIDED|95.0|1.19|1.8||Nominal value for 2-sided test calculated using Cox proportional hazards model adjusted for geographical cluster.|Cox proportional hazards model|||Risk ratio=hazard ratio estimated from the Cox proportional hazards model for assessing a treatment difference, risk ratio \< 1 is in favor of pregabalin. The 95% confidence interval is for the true risk ratio.||1.80|1.19|0.0003
72531176|NCT00280059|144591330|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.8||||0.0025|TWO_SIDED|95.0|0.3|1.4|||ANCOVA|||Anxiety; model includes treatment and geographical cluster as fixed effects and respective baseline scores as a continuous covariate.||1.4|0.3|0.0025
72531177|NCT00280059|144591330|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.6||||0.0186|TWO_SIDED|95.0|0.1|1.1|||ANCOVA|||Depression; model includes treatment and geographical cluster as fixed effects and respective baseline scores as a continuous covariate.||1.1|0.1|0.0186
72531178|NCT00280059|144591331|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.37||||0.0683|TWO_SIDED|95.0|0.98|1.93|||Regression, Logistic|||Week 8: dichotomized sleep assessment analyzed using a logistic regression model for repeated measures with fixed effects for treatment, geographical region, the average hours per night of sleep at baseline as a continuous covariate, time, and treatment-by-time interaction. The within subject covariance structure assumes an auto-regressive of order one covariance structure.||1.93|0.98|0.0683
72572084|NCT02912650|144671813|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-6.23||||0.023|TWO_SIDED|95.0|-11.61|-0.84|||Cochran-Mantel-Haenszel|||2 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||-0.84|-11.61|0.023
72531179|NCT00280059|144591331|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.14||||0.5096|TWO_SIDED|95.0|0.78|1.66|||Regression, Logistic|||Week 32: dichotomized sleep assessment analyzed using a logistic regression model for repeated measures with fixed effects for treatment, geographical region, the average hours per night of sleep at baseline as a continuous covariate, time, and treatment-by-time interaction. The within subject covariance structure assumes an auto-regressive of order one covariance structure.||1.66|0.78|0.5096
72531180|NCT00280059|144591331|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.09||||0.6804|TWO_SIDED|95.0|0.73|1.63|||Regression, Logistic|||Week 56 (termination): dichotomized sleep assessment analyzed using a logistic regression model for repeated measures with fixed effects for treatment, geographical region, the average hours per night of sleep at baseline as a continuous covariate, time, and treatment-by-time interaction. The within subject covariance structure assumes an auto-regressive of order one covariance structure.||1.63|0.73|0.6804
72531181|NCT00951912|144591363|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.7981|STANDARD_ERROR_OF_MEAN|2.422|<|0.05|TWO_SIDED|95.0|-6.6569|5.0607|||ANOVA|||"Null hypothesis: There are no difference in the difference of changes in plasma glucose.~Power calculation: The sample size of 55 subjects per group provided about 90% power to detect a significant change in the FG concentration of 8 mg/dL (7%) by using a general assumption of a 2-tailed a level of 0.05 and allowing for a 20% withdrawal rate."||5.0607|-6.6569|<0.05
72531182|NCT00951912|144591363|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.0842|STANDARD_ERROR_OF_MEAN|2.411|<|0.05|TWO_SIDED|95.0|-2.7486|8.9171|||ANOVA|||||8.9171|-2.7486|<0.05
72625741|NCT02521285|144781048|SUPERIORITY|||||||0.397|||||||t-test, 2 sided|||Difference between arms||||0.397
72531183|NCT00951912|144591363|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.8823|STANDARD_ERROR_OF_MEAN|2.399|<|0.05|TWO_SIDED|95.0|-1.9234|9.6881|||ANOVA|||||9.6881|-1.9234|<0.05
72531184|NCT00951912|144591364|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.7696|STANDARD_ERROR_OF_MEAN|4.2|<|0.05|TWO_SIDED|95.0|-11.9308|8.3916|||ANOVA|||||8.3916|-11.9308|<0.05
72531185|NCT00951912|144591364|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.6929|STANDARD_ERROR_OF_MEAN|4.1818|<|0.05|TWO_SIDED|95.0|-9.4232|10.8091|||ANOVA|||||10.8091|-9.4232|<0.05
72531186|NCT00951912|144591364|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.4626|STANDARD_ERROR_OF_MEAN|4.1624|<|0.05|TWO_SIDED|95.0|-7.6067|12.5318|||ANOVA|||||12.5318|-7.6067|<0.05
72531187|NCT00951912|144591365|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.01174|STANDARD_ERROR_OF_MEAN|1.45967|<|0.05|TWO_SIDED|95.0|-3.5428|3.5194|||ANOVA|||||3.5194|-3.5428|<0.05
72572085|NCT02912650|144671813|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-6.23||||0.026|TWO_SIDED|95.0|-11.73|-0.73|||Cochran-Mantel-Haenszel|||2 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||-0.73|-11.73|0.026
72572086|NCT02912650|144671813|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-41.51|||<|0.001|TWO_SIDED|95.0|-55.51|-27.52|||Cochran-Mantel-Haenszel|||2 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||-27.52|-55.51|<0.001
72625742|NCT02521285|144781048|SUPERIORITY|||||||0.983|||||||t-test, 2 sided|||Difference in arms.||||0.983
72625743|NCT02521285|144781049|SUPERIORITY|||||||0.065|||||||t-test, 2 sided|||||||0.065
72625744|NCT02521285|144781049|SUPERIORITY|||||||0.203|||||||t-test, 2 sided|||||||0.203
72625745|NCT02521285|144781050|SUPERIORITY|||||||0.755|||||||t-test, 2 sided|||||||0.755
72531188|NCT00951912|144591365|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.68659|STANDARD_ERROR_OF_MEAN|1.4532|<|0.05|TWO_SIDED|95.0|-6.202|0.8288|||ANOVA|||||0.8288|-6.2020|<0.05
72531189|NCT00951912|144591365|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.67485|STANDARD_ERROR_OF_MEAN|1.44646|<|0.05|TWO_SIDED|95.0|-6.174|0.8243|||ANOVA|||||0.8243|-6.174|<0.05
72531190|NCT00951912|144591366|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.9661|STANDARD_ERROR_OF_MEAN|3.14977|<|0.05|TWO_SIDED|95.0|-10.5857|4.6535|||ANOVA|||||4.6535|-10.5857|<0.05
72531191|NCT00951912|144591366|SUPERIORITY_OR_OTHER||Odds Ratio, log|-0.9972|STANDARD_ERROR_OF_MEAN|3.13581|<|0.05|TWO_SIDED|95.0|-8.583|6.5886|||ANOVA|||||6.5886|-8.5830|<0.05
72531192|NCT00951912|144591366|SUPERIORITY_OR_OTHER||Median Difference (Net)|1.9689|STANDARD_ERROR_OF_MEAN|3.12126|<|0.05|TWO_SIDED|95.0|-5.5817|9.5195|||ANOVA|||||9.5195|-5.5817|<0.05
72531193|NCT00951912|144591367|SUPERIORITY_OR_OTHER||Mean Rank|1.442|||<|0.05|||||||Kruskal-Wallis|||||||<0.05
72531194|NCT00951912|144591368|SUPERIORITY_OR_OTHER||Mean Ranks|1.895|||<|0.05|||||||Kruskal-Wallis|||||||<0.05
72531195|NCT00951912|144591369|SUPERIORITY_OR_OTHER||Mean Ranks|2.169|||<|0.05|||||||Kruskal-Wallis|||||||<0.05
72531196|NCT00951912|144591370|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.437|STANDARD_ERROR_OF_MEAN|4.9113|<|0.05|TWO_SIDED|95.0|-8.444|15.318|||ANOVA|||||15.318|-8.444|<0.05
72407985|NCT03851016|144324371|SUPERIORITY|||||||0.113|||||||Mancova|||"Null hypothesis is that there would be no difference in change of depressive symptoms between Life Story Book Intervention and Usual Care. A multivariate analysis of covariance (MANCOVA) models with the GDS-12R at baseline as the covariate, and the treatment group and study site as factors. The test was performed with a significance level of 0.05.~A sample size of 20 was needed to provide 90% power to detect a 5 point difference in depressive symptoms."||||.113
72407986|NCT03851016|144324372|SUPERIORITY|||||||0.123|||||||Mancova|||"Null hypothesis is that there would be no difference in change of Presence of Meaning (POM) between Life Story Book Intervention and Usual Care. A multivariate analysis of covariance (MANCOVA) models with the POM at baseline as the covariate, and the treatment group and study site as factors. The test was performed with a significance level of 0.05.~A sample size of 20 was needed to provide 90% power to detect a 5 point difference in POM."||||.123
72531197|NCT00951912|144591370|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.4809|STANDARD_ERROR_OF_MEAN|4.8896|<|0.05|TWO_SIDED|95.0|-8.3475|15.3092|||ANOVA|||||15.3092|-8.3475|<0.05
72531198|NCT00951912|144591370|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0439|STANDARD_ERROR_OF_MEAN|4.8669|<|0.05|TWO_SIDED|95.0|-11.7296|11.8174|||ANOVA|||||11.8174|-11.7296|<0.05
72531199|NCT00951912|144591371|SUPERIORITY_OR_OTHER||Mean ranks|1.031|||<|0.05|||||||Kruskal-Wallis|||||||<0.05
72531200|NCT00951912|144591372|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.8185|STANDARD_ERROR_OF_MEAN|3.2343|<|0.05|TWO_SIDED|95.0|-6.0057|9.6426|||ANOVA|||||9.6426|-6.0057|<0.05
72531201|NCT00951912|144591372|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.0276|STANDARD_ERROR_OF_MEAN|3.2199|<|0.05|TWO_SIDED|95.0|-6.7619|8.817|||ANOVA|||||8.8170|-6.7619|<0.05
72531202|NCT00951912|144591372|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.7909|STANDARD_ERROR_OF_MEAN|3.205|<|0.05|TWO_SIDED|95.0|-8.5442|6.9624|||ANOVA|||||6.9624|-8.5442|<0.05
72531203|NCT00951912|144591373|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.0122|STANDARD_ERROR_OF_MEAN|4.1686|<|0.05|TWO_SIDED|95.0|-8.0721|12.0964|||ANOVA|||||12.0964|-8.0721|<0.05
72531204|NCT00951912|144591373|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.7716|STANDARD_ERROR_OF_MEAN|4.1501|<|0.05|TWO_SIDED|95.0|-10.8111|9.2679|||ANOVA|||||9.2679|-10.8111|<0.05
72531205|NCT00951912|144591373|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.7837|STANDARD_ERROR_OF_MEAN|4.1309|<|0.05|TWO_SIDED|95.0|-12.7767|7.2092|||ANOVA|||||7.2092|-12.7767|<0.05
72531206|NCT00951912|144591374|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.4437|STANDARD_ERROR_OF_MEAN|0.1001|<|0.05|TWO_SIDED|95.0|-0.6416|-0.2458|||ANOVA|||||-0.2458|-0.6416|<0.05
72531207|NCT00951912|144591374|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1986|STANDARD_ERROR_OF_MEAN|0.09986|<|0.05|TWO_SIDED|95.0|-0.3956|-0.0016|||ANOVA|||||-0.0016|-0.3956|<0.05
72531208|NCT00951912|144591374|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.2451|STANDARD_ERROR_OF_MEAN|0.09648|<|0.05|TWO_SIDED|95.0|0.0544|0.4358|||ANOVA|||||0.4358|0.0544|<0.05
72531209|NCT00951912|144591375|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.6353|STANDARD_ERROR_OF_MEAN|0.1146|<|0.05|TWO_SIDED|95.0|-0.8617|-0.4089|||ANOVA|||||-0.4089|-0.8617|<0.05
72531210|NCT00951912|144591375|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0282|STANDARD_ERROR_OF_MEAN|0.1156||0.05|TWO_SIDED|95.0|-0.2003|0.2568|||ANOVA|||||0.2568|-0.2003|0.05
72531211|NCT00951912|144591375|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.6635|STANDARD_ERROR_OF_MEAN|0.1121|<|0.05|TWO_SIDED|95.0|0.4419|0.8851|||ANOVA|||||0.8851|0.4419|<0.05
72531212|NCT00951912|144591376|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1557|STANDARD_ERROR_OF_MEAN|0.119|<|0.05||95.0|-0.3911|0.0796|||ANOVA|||||0.0796|-0.3911|<0.05
72531213|NCT00951912|144591376|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.606|STANDARD_ERROR_OF_MEAN|0.119||0.05|TWO_SIDED|95.0|-0.8414|-0.3707|||ANOVA|||||-0.3707|-0.8414|0.05
72531214|NCT00951912|144591376|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.4503|STANDARD_ERROR_OF_MEAN|0.1163|<|0.05|TWO_SIDED|95.0|-0.6804|-0.2202|||ANOVA|||||-0.2202|-0.6804|<0.05
72531215|NCT00951912|144591377|SUPERIORITY_OR_OTHER||Mean Difference (Net)|102.4|STANDARD_ERROR_OF_MEAN|83.4|<|0.05|TWO_SIDED|95.0|-99.3|304.1|||ANOVA|||||304.1|-99.3|<0.05
72531216|NCT00951912|144591377|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.8|STANDARD_ERROR_OF_MEAN|82.6||0.05|TWO_SIDED|95.0|-203.7|196.1|||ANOVA|||||196.1|-203.7|0.05
72531217|NCT00951912|144591377|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-106.2|STANDARD_ERROR_OF_MEAN|82.2|<|0.05|TWO_SIDED|95.0|-305.1|92.8|||ANOVA|||||92.8|-305.1|<0.05
72531218|NCT02612194|144591455|OTHER|Estimation only.|Overall Response Rate|0.0|||||TWO_SIDED|95.0|0.0|0.369|||||Confidence interval estimated using the Clopper Pearson method.|||0.369|0.000|
72531219|NCT02612194|144591456|OTHER|Estimation only|Median|3.1|||||TWO_SIDED|95.0|0.2|6.1|||||The Kaplan Meier method was used to estimate the median OS (in months) for the population. The Greenwood method was used to estimate the confidence limits of the median overall survival.|||6.1|0.2|
72531220|NCT02612194|144591457|OTHER|Estimation only|Median|1.5|||||TWO_SIDED|95.0|0.2|1.8|||||The Kaplan Meier method was used to estimate the median PFS (in months) for the population. The Greenwood method was used to estimate the confidence limits of the median progression free survival.|||1.8|0.2|
72531221|NCT02539160|144591458|SUPERIORITY||Median Difference (Net)|6.4||||0.105|TWO_SIDED|95.0|-1.1|14.3|||t-test, 2 sided|||||14.3|-1.1|0.105
72625746|NCT02521285|144781050|SUPERIORITY|||||||0.343|||||||t-test, 2 sided|||||||0.343
72531222|NCT02539160|144591458|SUPERIORITY||Mean Difference (Final Values)|6.0||||0.112|TWO_SIDED|95.0|-1.5|13.7|||t-test, 2 sided|||||13.7|-1.5|0.112
72531223|NCT00149227|144591460|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.8|STANDARD_DEVIATION|2.0|<|0.05|TWO_SIDED|95.0|-0.975|0.975|||Cox's proportional hazard analysis|||"We estimated the number of enrolled patients to validate the hypothesis under the assumption that the valsartan add-on group achieves a 20% risk reduction compared with the conventional treatment group and gives 80% statistical power for detecting a clinical signiﬁcance with a two-tailed 5% statistical signiﬁcant level.~with a two-tailed 5% statistical signiﬁcant level."||0.975|-0.975|<0.05
72531224|NCT02312934|144591503|OTHER||||||=|0.41||||||All pairwise comparisons were Sidak corrected for multiple comparisons at the p \< 0.05 level.|Mixed Models Analysis|Degrees of freedom were corrected using Greenhouse-Geisser estimates of sphericity (ε = 0.72).||For the Primary Aim (Specific Aim 1), a mixed-models repeated measures ANOVA was used to assess the interaction of treatment group (nicotine, placebo) with time (Visit), using change from baseline PCI FACT-Cog score (Visit 3, Visit 4, and Visit 5) as the dependent measure.||||=0.41
72531225|NCT02312934|144591504|OTHER|||||||0.79||||||All pairwise comparisons were Sidak corrected for multiple comparisons at the p \< 0.05 level.|Mixed Models Analysis|Degrees of freedom were corrected using Greenhouse-Geisser estimates of sphericity (ε = 0.72).||For the Secondary Aim (Specific Aim 2), a mixed-models repeated measures ANOVA was used to assess the interaction of treatment group (nicotine, placebo) with time (Visit), using change from baseline CPT Scores (Visit 3, Visit 4, and Visit 5) as the dependent measure.||||0.79
72531226|NCT02978339|144591505|SUPERIORITY|||||||0.03|||||||t-test, 2 sided|||||||.03
72531227|NCT02978339|144591506|SUPERIORITY|||||||0.59|||||||t-test, 2 sided|||||||0.59
72531228|NCT02978339|144591507|SUPERIORITY|||||||0.91|||||||t-test, 2 sided|||||||0.91
72531229|NCT02978339|144591508|SUPERIORITY|||||||0.41|||||||t-test, 2 sided|||||||0.41
72531230|NCT02978339|144591509|SUPERIORITY|||||||0.15|||||||t-test, 2 sided|||||||.15
72625747|NCT02521285|144781051|SUPERIORITY|||||||0.281|||||||t-test, 2 sided|||||||0.281
72625748|NCT02521285|144781051|SUPERIORITY|||||||0.189|||||||t-test, 2 sided|||||||0.189
72625749|NCT02521285|144781052|SUPERIORITY|||||||0.083|||||||t-test, 2 sided|||||||0.083
72625750|NCT02521285|144781052|SUPERIORITY|||||||0.195|||||||t-test, 2 sided|||||||0.195
72531231|NCT02978339|144591510|SUPERIORITY|||||||0.06|||||||t-test, 2 sided|||||||.06
72531232|NCT02978339|144591511|SUPERIORITY|||||||0.93|||||||t-test, 2 sided|||||||.93
72531233|NCT00689299|144591515|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||ANOVA|||ANOVA with baseline score as covariate||||<0.05
72531234|NCT03395704|144591577|SUPERIORITY||||||<|0.0001|||||||General Linear Model|||||||< 0.0001
72531235|NCT00434876|144591583|SUPERIORITY_OR_OTHER|||||||0.49||95.0|||||Mixed Models Analysis|||||||0.49
72531236|NCT00434876|144591584|SUPERIORITY_OR_OTHER|||||||0.04||95.0|||||Mixed Models Analysis|||||||0.04
72531237|NCT00434876|144591585|SUPERIORITY_OR_OTHER|||||||0.57||95.0|||||Mixed Models Analysis|||||||0.57
72531238|NCT00434876|144591586|SUPERIORITY_OR_OTHER|||||||0.03||95.0|||||Mixed Models Analysis|||||||0.03
72531239|NCT00758394|144591587|SUPERIORITY_OR_OTHER||||||<|0.05||95.0||||Two way Anova general linear model (subject and treatment as factors). Multiple comparison completed to determine differences between groups.|ANOVA|||The null hypothesis states that there is no difference between groups.||||<0.05
72531240|NCT03539900|144591595|SUPERIORITY|Analyses used all available data. Analyses to compare treatments were all intent-to-treat.||||||0.44|||||||Mixed Models Analysis|Analyses were performed for all randomized participants. Models also considered weight status as a moderator or predictor.||||||.44
72531241|NCT03539900|144591596|SUPERIORITY|Analyses used all available data. Analyses to compare treatments were all intent-to-treat.||||||0.04|||||||Mixed Models Analysis|Analyses were performed for all randomized participants. Models also considered weight status as a predictor or moderator.||||||.04
72531242|NCT03539900|144591597|SUPERIORITY|||||||0.98|||||||ANOVA|Analyses used all available data without imputation.||||||.98
72531243|NCT03539900|144591598|SUPERIORITY|||||||0.44|||||||ANOVA|Analyses used all available data without imputation.||||||.44
72531244|NCT03539900|144591599|SUPERIORITY|||||||0.99|||||||ANOVA|Analyses used all available data without imputation.||||||.99
72531245|NCT03539900|144591600|SUPERIORITY|||||||0.4|||||||ANOVA|Analyses used all available data without imputation.||||||.40
72531246|NCT04823494|144591601|NON_INFERIORITY|For sample size in each sequence group is 16 (total N=32), a 2 X 2 crossover design will have 80% power to reject the null hypothesis that the SELF-FIT APHAB mean is inferior to the PRO-FIT APHAB mean. The non-inferiority difference margin is 8.4, the standard deviation of differences is 16.3, and p\<.025. The non-inferiority margin of 8.4 preserves half the 95% critical difference for the global APHAB score (16.8). The common standard deviation reported for the APHAB global score is 16.0.|Mean Difference (Final Values)|1.4|||<|0.025|TWO_SIDED|95.0|-1.59|4.73||There were two outcome measures, primary and secondary, considered. As a result, the a priori p value of .05 for statistical significance was adjusted for multiple comparisons to .025.|t-test, 1 sided|The mean differences and 95% CIs in APHAB global score between SELF-FIT and PRO-FIT were calculated using bias-corrected \& accelerated bootstrapping.|The mean difference and 95% CIs are for Self-Fit minus Pro-Fit aided scores. These values are the pooled data for all 37 participants, 19 receiving one sequence and 18 the other sequence.|"For the wear-time crossover field trial, the APHAB was measured following both the audiology best-practices hearing aid fitting (PRO-FIT) and the self-fitting method (SELF-FIT).~* Null hypothesis: Mean (APHAB SELF-FIT - APHAB PRO-FIT ) ≥ 8.4~* Alternative hypothesis: Mean (APHAB SELF-FIT - APHAB PRO-FIT) \< 8.4~The mean difference between the aided scores for the two fitting methods, Self-Fit minus Pro-Fit, represent the primary outcome measure. The expected difference = 0."||4.73|-1.59|<0.025
72625751|NCT02521285|144781053|SUPERIORITY|||||||0.755|||||||t-test, 2 sided|||||||0.755
72625752|NCT02521285|144781053|SUPERIORITY|||||||0.432|||||||t-test, 2 sided|||||||0.432
72625753|NCT02521285|144781054|SUPERIORITY|||||||0.463|||||||t-test, 2 sided|||||||0.463
72625754|NCT02521285|144781054|SUPERIORITY|||||||0.189|||||||t-test, 2 sided|||||||0.189
72625755|NCT02521285|144781055|SUPERIORITY|||||||0.105|||||||t-test, 2 sided|||||||0.105
72625756|NCT02521285|144781055|SUPERIORITY|||||||0.161|||||||t-test, 2 sided|||||||0.161
72625757|NCT02521285|144781058|SUPERIORITY|||||||0.518|||||||t-test, 2 sided|||||||0.518
72625758|NCT02521285|144781059|SUPERIORITY|||||||0.876|||||||t-test, 2 sided|||||||0.876
72625759|NCT02521285|144781059|SUPERIORITY|||||||0.505|||||||t-test, 2 sided|||||||0.505
72531247|NCT04823494|144591602|NON_INFERIORITY|For the QuickSIN, a clinically meaningful difference is 3 dB and half that difference resulted in a margin of 1.5 dB. This 1.5-dB margin was used for the QuickSIN for the non-inferiority analyses of the data from the field-trial component. The mean difference, QuickSIN Self-Fit minus QuickSIN Pro-Fit, should be less than 1.5 dB for the entire sample (N=37) to meet the non-inferiority criterion.|Mean Difference (Final Values)|0.58|||<|0.025|TWO_SIDED|95.0|-0.03|1.2||The a priori threshold value of 0.05 was Bonferroni-adjusted to 0.025 based on the use of two outcome measures, APHAB global (primary) and QuickSIN (secondary).|t-test, 1 sided|The mean differences in dB, SELF-FIT minus PRO-FIT, were calculated with 95% confidence intervals (bias-corrected, accelerated bootstrap) generated.|Mean differences in aided QuickSIN SNR in dB, Self-Fit minus Pro-Fit, were calculated for the entire group of 37 participants with about 1/2 receiving one of the two fit sequences (Pro-Fit then Self-Fit or Self-Fit then Pro-Fit).|"For the QuickSIN, aided performance after each wear period was compared between SELF-FIT and PRO-FIT.~* Null hypothesis: Mean (QuickSIN SELF-FIT - QuickSIPRO-FIT) ≥ 1.5 dB~* Alternative hypothesis: Mean (QuickSIN SELF-FIT - QuickSIN PRO-FIT) \< 1.5 dB~Power calculations were based on the primary outcome measured, the aided APHAB global score, (see information for that outcome measure). With the minimum required N of 32 based on the APHAB global score, the power for QuickSIN exceeded 80%."||1.20|-0.03|<0.025
72531248|NCT03691831|144591615|SUPERIORITY||Odds Ratio (OR)|4.8||||0.0001|TWO_SIDED|95.0|2.14|10.76||P-Value test comparing the Patients Cleared of All Baseline Warts in the Active (A-101 45%) and vehicle groups.|Mixed Models Analysis|||A summary of the wart clearance at Visit 10.||10.76|2.14|0.0001
72531249|NCT03691831|144591616|SUPERIORITY||Mean Difference (Final Values)|2.71||||0.0001|TWO_SIDED|95.0|1.61|4.56|||Mixed Models Analysis|||P-Value test comparing the Patients Cleared of All Baseline Warts in the Active (A-101 45%) and vehicle groups.||4.56|1.61|0.0001
72531250|NCT03691831|144591617|SUPERIORITY||Odds Ratio (OR)|15.44|||<|0.0001|TWO_SIDED|95.0|9.0|21.8|||Wilcoxon (Mann-Whitney)|||||21.8|9.0|<0.0001
72531251|NCT03691831|144591618|SUPERIORITY||Odds Ratio (OR)|5.2||||0.0006|TWO_SIDED|95.0|1.76|15.53|||Wilcoxon (Mann-Whitney)|||||15.53|1.76|0.0006
72531252|NCT03691831|144591619|SUPERIORITY||Hazard Ratio (HR)|3.33|||<|0.0001|TWO_SIDED||||||Log Rank|||||||<0.0001
72531253|NCT03922945|144591620|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||||||<0.0001
72531254|NCT03922945|144591621|SUPERIORITY||||||<|0.0017|||||||Cochran-Mantel-Haenszel|||||||<0.0017
72531255|NCT03922945|144591628|SUPERIORITY|||||||0.7465|||||||Mixed Models Analysis|||||||0.7465
72531256|NCT01347931|144591648|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.0|STANDARD_DEVIATION|7.0|<|0.05|TWO_SIDED|95.0|2.0|10.0|||t-test, 2 sided|||A sample size of 26 patient pairs was determined based on the assumption of a true treatment difference in mean ADL endurance time of 4 ± 7 minutes using a two-tailed, paired t test (α=0.05, power=0.80).||10|2|<0.05
72625760|NCT02521285|144781060|SUPERIORITY|||||||0.463|||||||t-test, 2 sided|||||||0.463
72625761|NCT02521285|144781060|SUPERIORITY|||||||0.094|||||||t-test, 2 sided|||||||0.094
72625762|NCT02521285|144781061|SUPERIORITY|||||||0.105|||||||t-test, 2 sided|||||||0.105
72531257|NCT01347931|144591649|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.0|STANDARD_DEVIATION|4.0|<|0.05|TWO_SIDED|95.0|1.0|7.0|||t-test, 2 sided|||Two-tailed t test||7|1|<0.05
72531258|NCT01020812|144591653|SUPERIORITY_OR_OTHER||proportion of participants|0.286|||||TWO_SIDED|95.0|0.031|0.636|||||The data was analyzed in a competing risk model with death as a competing risk. The proportion of 0.286 is the cumulative incidence function at 12 months.|The data was analyzed in a competitive risk model with the cumulative incidence function as the estimator. Death and other progression were competitive risks.||0.636|0.031|
72531259|NCT01020812|144591654|SUPERIORITY_OR_OTHER||probability|0.4|||||TWO_SIDED||||||||This is the overall survival probability at 18 months.|The data was analyzed using the Kaplan Meier estimator.||||
72531260|NCT02528643|144591657|SUPERIORITY||Hazard Ratio (HR)|1.146||||0.248|TWO_SIDED|95.0|0.774|1.696||One-sided p-value.|Log Rank||Calculated using a Cox proportional hazard model, stratified by geographic region and ECOG performance status. Hazard ratio \< 1 indicated a reduction in hazard rate in favor of enzalutamide group.|Stratified Analysis. The null hypothesis was stated as: OS distributions of the 2 arms are equivalent. The alternative hypothesis was stated as: OS is prolonged in enzalutamide arm. The null hypothesis was tested using a stratified one-sided log-rank test at the 0.10 level. Stratification factors were ECOG performance status and region from eCRF.||1.696|0.774|0.248
72531261|NCT02528643|144591657|SUPERIORITY||Hazard Ratio (HR)|1.142||||0.252|TWO_SIDED|95.0|0.773|1.688||One-sided p-value.|Log Rank||Calculated using a Cox proportional hazard model. Hazard ratio \< 1 indicated a reduction in hazard rate in favor of enzalutamide group.|Unstratified Analysis. The null hypothesis was stated as: OS distributions of the 2 arms are equivalent. The alternative hypothesis was stated as: OS is prolonged in enzalutamide arm. The null hypothesis was tested using a one-sided log-rank test at the 0.10 level.||1.688|0.773|0.252
72531262|NCT02528643|144591662|SUPERIORITY||Hazard Ratio (HR)|1.039||||0.396|TWO_SIDED|95.0|0.732|1.474||One-sided p-value.|Log Rank||Calculated using a Cox proportional hazard model, stratified by ECOG performance status and region. Hazard ratio \< 1 indicated a reduction in hazard rate in favor of enzalutamide group.|Stratified Analysis. The null hypothesis was stated as: PFS distributions of the 2 arms are equivalent. The alternative hypothesis was stated as: PFS is prolonged in enzalutamide arm. The null hypothesis was tested using a stratified one-sided log-rank test at the 0.10 level. Stratification factors were ECOG performance status and region from eCRF.||1.474|0.732|0.396
72625763|NCT02521285|144781061|SUPERIORITY|||||||0.13|||||||t-test, 2 sided|||||||0.13
72625764|NCT04251533|144781072|SUPERIORITY||Hazard Ratio (HR)|1.49|||||TWO_SIDED|95.0|0.92|2.41|||Regression, Cox|||||2.41|0.92|
72625765|NCT06378008|144781091|SUPERIORITY||Adjusted Mean Difference|-1.8|STANDARD_ERROR_OF_MEAN|0.092|<|0.0001|TWO_SIDED|95.0|-1.98|-1.62|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as test toothpaste minus reference toothpaste.|Change from Baseline at Day 56||-1.62|-1.98|<0.0001
72625766|NCT06378008|144781092|SUPERIORITY||Adjusted Mean Difference|52.87|STANDARD_ERROR_OF_MEAN|2.428|<|0.0001|TWO_SIDED|95.0|48.08|57.65|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as test toothpaste minus reference toothpaste.|Change from Baseline at Day 56||57.65|48.08|<0.0001
72625767|NCT06378008|144781093|SUPERIORITY||Adjusted Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.053||0.0005|TWO_SIDED|95.0|-0.29|-0.08|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as test toothpaste minus reference toothpaste.|Change from Baseline at Day 3||-0.08|-0.29|0.0005
72625768|NCT06378008|144781093|SUPERIORITY||Adjusted Mean Difference|-0.61|STANDARD_ERROR_OF_MEAN|0.063|<|0.0001|TWO_SIDED|95.0|-0.73|-0.49|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as test toothpaste minus reference toothpaste.|Change from Baseline at Day 7||-0.49|-0.73|<0.0001
72531263|NCT02528643|144591662|SUPERIORITY||Hazard Ratio (HR)|0.959||||0.586|TWO_SIDED|95.0|0.684|1.345||One-sided p-value.|Log Rank||Calculated using a Cox proportional hazard model. Hazard ratio \< 1 indicated a reduction in hazard rate in favor of enzalutamide group.|Unstratified Analysis. The null hypothesis was stated as: PFS distributions of the 2 arms are equivalent. The alternative hypothesis was stated as: PFS is prolonged in enzalutamide arm. The null hypothesis was tested using a one-sided log-rank test at the 0.10 level.||1.345|0.684|0.586
72531264|NCT04120116|144591663|SUPERIORITY||Odds Ratio (OR)|0.3||||0.068|TWO_SIDED|95.0|0.11|1.08||P value for statistical significance is \<0.05|Mixed Models Analysis|||||1.08|0.11|0.068
72531265|NCT04120116|144591665|SUPERIORITY||Least squares mean difference|1.25|STANDARD_ERROR_OF_MEAN|2.611||0.634|TWO_SIDED|95.0|-3.945|6.439||P value for statistical significance is \<0.05|Mixed Models Analysis|||||6.439|-3.945|0.634
72531266|NCT02087085|144591669|SUPERIORITY||Least Squares Mean Difference|-0.3589|STANDARD_ERROR_OF_MEAN|0.1804||0.047|TWO_SIDED|95.0|-0.7132|-0.0047||MMRM model included treatment group, study region, analysis visit and treatment-by-visit interaction as factors and baseline value and baseline value-by-analysis visit interaction as covariates.|MMRM|||||-0.0047|-0.7132|0.047
72531267|NCT02087085|144591670|SUPERIORITY||Least Squares Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|1.4||0.39|TWO_SIDED|95.0|-3.9|1.5||MMRM model included treatment group, study region, analysis visit and treatment-by-visit interaction as factors and baseline value and baseline value-by-analysis visit interaction as covariates.|MMRM|||||1.5|-3.9|0.390
72531268|NCT02087085|144591671|SUPERIORITY||Least Squares Mean Difference|-1.4|STANDARD_ERROR_OF_MEAN|1.4||0.301|TWO_SIDED|95.0|-4.2|1.3||MMRM model included treatment group, study region, analysis visit and treatment-by-visit interaction as factors and baseline value and baseline value-by-analysis visit interaction as covariates.|MMRM|||||1.3|-4.2|0.301
72531269|NCT01729559|144591706|NON_INFERIORITY_OR_EQUIVALENCE|A 10% noninferiority margin was selected based on a previous trial showing a difference in the incidence of DVT of 13% with the use of 30 mg of enoxaparin every 12 hours compared to 5,000 U of unfractionated heparin (UFH) every 12 hr. To achieve 90% power using an a priori margin of 10% with a one-sided alpha of 0.025, a total of 182 patients (91 in each arm) was required.|Risk Difference (RD)|6.5||||0.025|TWO_SIDED|95.0|-2.9|15.8||One-tailed test of the cumulative VTE incidence between treatment groups.|Chi-squared, Corrected||Unadjusted cumulative incidence values between the two treatment groups were subtracted to calculate the risk difference for VTE between groups. This difference was compared to the a priori 10% margin of difference using the 95% confidence interval.|Analysis was performed in a subset of patients who received at least one follow-up venous duplex ultrasound of the lower extremities.||15.8|-2.9|0.025
72531270|NCT01729559|144591706|NON_INFERIORITY_OR_EQUIVALENCE|A 10% noninferiority margin was selected based on these data showing a difference in the incidence of DVT of 13% with the use of 30 mg of enoxaparin every 12 hours compared to 5,000 U of UFH every 12 hours. To achieve 90% power using an a priori margin of 10% with a one-sided alpha of 0.025, a total of 182 patients (91 in each arm) was required. This analysis was performed in the entire sample.|Risk Difference (RD)|3.1||||0.025|TWO_SIDED|95.0|-1.6|7.7||One-tailed test of the cumulative VTE incidence between treatment groups.|Chi-squared, Corrected||Unadjusted cumulative incidence values between the two treatment groups were subtracted to calculate the risk difference for VTE between groups. This difference was compared to the a priori 10% margin of difference using the 95% confidence interval.|"Analysis was performed in the total sample of eligible patients and who received their assigned treatment (referred to as the randomized treated sample) ."||7.7|-1.6|0.025
72572087|NCT02912650|144671813|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-41.77|||<|0.001|TWO_SIDED|95.0|-55.65|-27.89|||Cochran-Mantel-Haenszel|||2 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||-27.89|-55.65|<0.001
72531271|NCT03764813|144591712|SUPERIORITY||||||<|0.0001|||||||Kruskal-Wallis|||Group comparison is carried out among HbF values grouped according to the transfusion regimen (only cord blood transfusions, only adult transfusions, both cord and adult transfusions).||||<0.0001
72531272|NCT03764813|144591713|SUPERIORITY||Median Difference (Final Values)|0.165|||<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<0.05
72531273|NCT03764813|144591714|SUPERIORITY||Median Difference (Final Values)|0.537|||<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<0.05
72531274|NCT03764813|144591715|SUPERIORITY||||||<|0.0001|||||||Kruskal-Wallis|||Group comparison is carried out among HbF values grouped according to the transfusion regimen (only cord blood transfusions, only adult transfusions, both cord and adult transfusions).||||<0.0001
72542618|NCT01042977|144615156|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.02|STANDARD_ERROR_OF_MEAN|0.7983||0.0002|TWO_SIDED|95.0|-4.59|-1.46||Significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure|ANCOVA|with treatment group and stratum as effects and baseline value as covariate|with stratum = age-by-insulin use-by-time from most recent qualifying CV event|H0: mean(treat) minus mean(placebo) = 0 versus the alternative HA: mean(treat) minus mean(placebo) =/= 0||-1.46|-4.59|0.0002
72572088|NCT02912650|144671813|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-0.16||||0.96|TWO_SIDED|95.0|-6.56|6.23|||Cochran-Mantel-Haenszel|||2 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||6.23|-6.56|0.960
72572089|NCT02912650|144671813|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-55.73|||<|0.001|TWO_SIDED|95.0|-68.81|-42.65|||Cochran-Mantel-Haenszel|||3 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||-42.65|-68.81|<0.001
72572090|NCT02912650|144671813|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-6.16||||0.055|TWO_SIDED|95.0|-12.46|0.13|||Cochran-Mantel-Haenszel|||3 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||0.13|-12.46|0.055
72625769|NCT06378008|144781093|SUPERIORITY||Adjusted Mean Difference|-1.23|STANDARD_ERROR_OF_MEAN|0.092|<|0.0001|TWO_SIDED|95.0|-1.41|-1.04|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as test toothpaste minus reference toothpaste.|Change from Baseline at Day 14||-1.04|-1.41|<0.0001
72625770|NCT06378008|144781093|SUPERIORITY||Adjusted Mean Difference|-1.56|STANDARD_ERROR_OF_MEAN|0.093|<|0.0001|TWO_SIDED|95.0|-1.74|-1.38|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as test toothpaste minus reference toothpaste.|Change from Baseline at Day 28||-1.38|-1.74|<0.0001
72625771|NCT06378008|144781094|SUPERIORITY||Adjusted Mean Difference|7.14|STANDARD_ERROR_OF_MEAN|0.706|<|0.0001|TWO_SIDED|95.0|5.75|8.53|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as test toothpaste minus reference toothpaste.|Change from Baseline at Day 3||8.53|5.75|<0.0001
72625772|NCT06378008|144781094|SUPERIORITY||Adjusted Mean Difference|14.4|STANDARD_ERROR_OF_MEAN|1.112|<|0.0001|TWO_SIDED|95.0|12.2|16.59|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as test toothpaste minus reference toothpaste.|Change from Baseline at Day 7||16.59|12.20|<0.0001
72625773|NCT06378008|144781094|SUPERIORITY||Adjusted Mean Difference|25.8|STANDARD_ERROR_OF_MEAN|1.59|<|0.0001|TWO_SIDED|95.0|22.67|28.93|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as test toothpaste minus reference toothpaste.|Change from Baseline at Day 14||28.93|22.67|<0.0001
72625774|NCT06378008|144781094|SUPERIORITY||Adjusted Mean Difference|40.99|STANDARD_ERROR_OF_MEAN|2.254|<|0.0001|TWO_SIDED|95.0|36.55|45.43|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as test toothpaste minus reference toothpaste.|Change from Baseline at Day 28||45.43|36.55|<0.0001
72407987|NCT03851016|144324373|SUPERIORITY|||||||0.91|||||||Mancova|||"The null hypothesis is that there would be no difference in change of Search for Meaning (SFM) between Life Story Book Intervention and Usual Care. A multivariate analysis of covariance (MANCOVA) models with the SFM at baseline as the covariate, and the treatment group and study site as factors. The test was performed with a significance level of 0.05.~A sample size of 20 was needed to provide 90% power to detect a 5 point difference in SFM."||||.910
72531275|NCT01716585|144591721|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Based on historical SVR rates for noncirrhotic HCV treatment-naive subjects administered telaprevir plus peginterferon (pegIFN)/RBV, the lower confidence bound (LCB) of the 95% confidence interval (CI) must have exceeded 70% to achieve noninferiority of the ABT-450/r/ABT-267 and ABT-333, plus RBV treatment group as compared with the historical rate for telaprevir plus pegIFN and RBV, and the LCB of the 95% CI must have exceeded 80% to achieve superiority.|Percentage of Participants with SVR12|96.4|||||TWO_SIDED|95.0|94.7|98.1|||||In order to control the Type I error rate at 0.05, a fixed-sequence testing procedure was used to proceed through the primary and first 3 secondary efficacy endpoints in the order numbered below.|With a sample size of 450 subjects and assuming that 92% of the subjects in Arm A will achieve SVR12, this study has greater than 90% power to demonstrate non-inferiority with a 2-sided 95% lower confidence bound greater than 70% and greater than 90% power to demonstrate superiority with a 2-sided 95% lower confidence bound greater than 80% (based on the normal approximation of a single binomial proportion). 95% CI calculated using the normal approximation to the binomial distribution.||98.1|94.7|
72531276|NCT01716585|144591722|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||In order to control the Type I error rate at 0.05, a fixed-sequence testing procedure will be used to proceed through the primary and first 3 secondary efficacy endpoints in the order numbered below.|Fisher Exact|||||||< 0.001
72531277|NCT01716585|144591723|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Based on historical SVR rates for noncirrhotic HCV treatment-naive subjects of the appropriate HCV genotype 1 subtype administered telaprevir plus pegIFN/RBV, the lower confidence bound (LCB) of the 95% confidence interval (CI) must have exceeded 75% to achieve superiority of the ABT-450/r/ABT-267 and ABT-333, plus RBV treatment group as compared with the historical rate for telaprevir plus pegIFN and RBV.|Percentage of Participants with SVR12|95.7|||||TWO_SIDED|95.0|93.4|97.9||In order to control the Type I error rate at 0.05, a fixed-sequence testing procedure will be used to proceed through the primary and first 3 secondary efficacy endpoints in the order numbered below.|||95% CI calculated using the normal approximation to the binomial distribution.|||97.9|93.4|
72625775|NCT06378008|144781095|SUPERIORITY||Adjusted Mean Difference|-0.21|STANDARD_ERROR_OF_MEAN|0.219||0.3489|TWO_SIDED|95.0|-0.64|0.23|||Mixed Model with Repeated Measures||Adjusted Mean Difference was calculated as Test Toothpaste minus Reference Toothpaste.|Q7 (How intense are the sensations?): Change from Baseline at Day 28||0.23|-0.64|0.3489
72625776|NCT06378008|144781095|SUPERIORITY||Adjusted Mean Difference|-0.46|STANDARD_ERROR_OF_MEAN|0.267||0.0876|TWO_SIDED|95.0|-0.98|0.07|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as Test Toothpaste minus Reference Toothpaste.|Q7 (How intense are the sensations?): Change from Baseline at Day 56||0.07|-0.98|0.0876
72625777|NCT06378008|144781095|SUPERIORITY||Adjusted Mean Difference|0.03|STANDARD_ERROR_OF_MEAN|0.252||0.9108|TWO_SIDED|95.0|-0.47|0.52|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as Test Toothpaste minus Reference Toothpaste.|Q8 (How bothered are you by any sensations?): Change from Baseline at Day 28||0.52|-0.47|0.9108
72625778|NCT06378008|144781095|SUPERIORITY||Adjusted Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.281||0.4854|TWO_SIDED|95.0|-0.75|0.36|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as Test Toothpaste minus Reference Toothpaste.|Q8 (How bothered are you by any sensations?): Change from Baseline at Day 56||0.36|-0.75|0.4854
72625779|NCT06378008|144781095|SUPERIORITY||Adjusted Mean Difference|0.06|STANDARD_ERROR_OF_MEAN|0.261||0.8309|TWO_SIDED|95.0|-0.46|0.57|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as Test Toothpaste minus Reference Toothpaste.|Q9 (How well can you tolerate sensations?): Change from Baseline at Day 28||0.57|-0.46|0.8309
72625780|NCT06378008|144781095|SUPERIORITY||Adjusted Mean Difference|-0.58|STANDARD_ERROR_OF_MEAN|0.297||0.05|TWO_SIDED|95.0|-1.17|0.0|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as Test Toothpaste minus Reference Toothpaste.|Q9 (How well can you tolerate sensations?): Change from Baseline at Day 56||-0.00|-1.17|0.0500
72407988|NCT03551210|144324396|NON_INFERIORITY|The non-inferiority bound was designated at the level of -15%|Difference in percentage|6.1|||||TWO_SIDED|95.0|-0.7|13.0||||||||13.0|-0.7|
72407989|NCT03551210|144324396|OTHER||Odds Ratio (OR)|1.45|||=|0.499|TWO_SIDED|95.0|0.49|4.29|||Regression, Logistic|||||4.29|0.49|=0.499
72531278|NCT01716585|144591724|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Based on historical SVR rates for noncirrhotic HCV treatment-naive subjects of the appropriate HCV genotype 1 subtype administered telaprevir plus pegIFN/RBV, the lower confidence bound (LCB) of the 95% confidence interval (CI) must have exceeded 84% to achieve superiority of the ABT-450/r/ABT-267 and ABT-333, plus RBV treatment group as compared with the historical rate for telaprevir plus pegIFN and RBV.|Percentage of Participants with SVR12|98.0|||||TWO_SIDED|95.0|95.8|100.0|||||95% CI calculated using the normal approximation to the binomial distribution.|||100.0|95.8|
72531279|NCT04646668|144591727|SUPERIORITY|Due to the pilot nature of the current study, formal power calculations were not conducted.||||||0.002|||||||ANOVA|||The null hypothesis is that there is no difference in nicotine delivery between cigarettes, e-cigarettes, and heat not burn after the standardized 10-puff bout. ANOVAs were conducted to detect differences between products for nicotine concentration at five minutes (immediately following 10-puff bout). The test was performed with a significance level of 0.05 (two-sided).||||0.002
72531280|NCT01707667|144591728|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.8||||0.012|TWO_SIDED|95.0|1.6|9.9|||Linear Mixed-Effect Models Analysis|||||9.9|1.6|0.012
72531281|NCT01707667|144591729|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|69051.4||||0.079|TWO_SIDED|95.0|-12004.5|150107.3|||Linear Mixed-Effect Models Analysis|||||150107.3|-12004.5|0.079
72531282|NCT01707667|144591730|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|9.2||||0.717|TWO_SIDED|95.0|-45.3|63.7|||Linear Mixed-Effect Models Analysis|||||63.7|-45.3|0.717
72531283|NCT01707667|144591731|SUPERIORITY_OR_OTHER_LEGACY|||||||0.295|TWO_SIDED||||||Log Rank|||||||0.295
72531284|NCT01707667|144591732|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.179||||0.18|TWO_SIDED|95.0|-0.465|0.107|||Linear Mixed-Effect Models Analysis|||||0.107|-0.465|0.180
72531285|NCT01707667|144591733|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|15.8||||0.225|TWO_SIDED|95.0|-12.6|44.3|||Linear Mixed-Effect Models Analysis|||||44.3|-12.6|0.225
72531286|NCT00851721|144591769|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0003||95.0|||||Two-sample, two-sided t-test|||H0: μ(on-demand) = μ(prophylaxis) Versus H1: μ(on-demand) ≠ μ(prophylaxis) (Where H0 implies no difference in mean bleeding episode rate between prophylaxis and on-demand treatment arms and H1 implies otherwise. This test was performed at a significance level of 5%, two-sided, two sample)||||0.0003
72531287|NCT00851721|144591771|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0008|||||||Two-sample, two-sided t-test|||Spontaneous Bleeds||||0.0008
72531288|NCT00851721|144591771|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0199|||||||Two-sample, two-sided t-test|||Traumatic Bleeds||||0.0199
72531289|NCT00851721|144591771|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0006|||||||Two-sample, two-sided t-test|||Joint Bleeds||||0.0006
72531290|NCT00851721|144591771|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0227|||||||Two-sample, two-sided t-test|||Non-Joint Bleeds||||0.0227
72531291|NCT00851721|144591771|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0013|||||||Two-sample, two-sided t-test|||Spontaneous Joint Bleeds||||0.0013
72531292|NCT00851721|144591771|SUPERIORITY_OR_OTHER_LEGACY|||||||0.003|||||||Two-sample, two-sided t-test|||Spontaneous Non-Joint Bleeds||||0.0030
72531293|NCT00851721|144591771|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0254|||||||Two-sample, two-sided t-test|||Traumatic Joint Bleeds||||0.0254
72531294|NCT00851721|144591771|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9322|||||||Two-sample, two-sided t-test|||Traumatic Non-Joint Bleeds||||0.9322
72531295|NCT00851721|144591773|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0271|||||||Two-sample, two-sided t-test|||||||0.0271
72531296|NCT00851721|144591780|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0067||95.0|||||Mann-Whitney tests (Wilcoxon-Rank Sum)|||||||0.0067
72531297|NCT03485976|144591846|OTHER||||||<|0.001||||||The threshold for statistical significance was p=0.05|t-test, 2 sided|||||||<0.001
72531298|NCT03485976|144591847|OTHER|||||||0.004||||||The threshold for significance was p=0.05|t-test, 2 sided|||||||0.004
72531299|NCT03485976|144591848|OTHER|||||||0.001||||||Threshold for significance was p=0.05|t-test, 2 sided|||||||0.001
72531300|NCT00529152|144591864|SUPERIORITY_OR_OTHER|||||||0.0005|||||||Regression, Linear|||Change in Serum Ferritin from baseline to week 24 was compared using regression analysis; null hypothesis was defined as no change in serum ferritin from baseline to week 24||||0.0005
72531301|NCT01680835|144591865|OTHER|Freedom from primary safety composite event at 36 months compared to a performance goal of 35%|Kaplan Meier|0.771|||<|0.001|ONE_SIDED|97.5|0.678||||Log Rank||||||0.678|<0.001
72531302|NCT01680835|144591866|OTHER|No hypothesis Testing for this endpoint.|Kaplan Meier|1.0|STANDARD_ERROR_OF_MEAN|0.0|||TWO_SIDED|||||||||Stent Fracture at 1 Year||||
72531303|NCT01680835|144591866|OTHER|No hypothesis testing was done for this endpoint.|Kaplan Meier|0.989|STANDARD_ERROR_OF_MEAN|0.01|||TWO_SIDED|||||||||Stent Fracture at 2 Years||||
72531304|NCT01680835|144591866|OTHER|No hypothesis testing was done for this endpoint|Kaplan Meier|0.965|STANDARD_ERROR_OF_MEAN|0.02|||TWO_SIDED|||||||||Stent Fracture at 3 Years||||
72531305|NCT01680835|144591867|OTHER|No hypothesis testing was done at this endpoint|Kaplan Meier|0.86|STANDARD_ERROR_OF_MEAN|0.034|||TWO_SIDED|||||||||Freedom from acute death, freedom from amputation and freedom from clinically-driven target lesion revascularization at 1 year||||
72531306|NCT01680835|144591867|OTHER|No hypothesis testing was done for this endpoint.|Kaplan Meier|0.782|STANDARD_ERROR_OF_MEAN|0.04|||TWO_SIDED|||||||||Freedom from acute death, freedom from amputation and freedom from clinically-driven target lesion revascularization at 2 years||||
72531307|NCT01680835|144591868|OTHER|No hypothesis testing was done for this endpoint.|Kaplan Meier|0.99|STANDARD_ERROR_OF_MEAN|0.01|||TWO_SIDED|||||||||Estimate from freedom from major amputation through 3 years.||||
72531308|NCT01680835|144591869|OTHER||Kaplan Meier|0.781|STANDARD_ERROR_OF_MEAN|0.04|||TWO_SIDED|||||||||Freedom from clinically-driven TLR through 3 Years||||
72531309|NCT01140646|144591907|SUPERIORITY_OR_OTHER|||||||0.0903||||||One sided t-test with 0.05 error rate was employed.|t-test, 1 sided|||To determine whether any reduction in hot flash score is beyond what is expected with a placebo (20-25%). Reference: Sloan JA, et al. Methodologic lessons learned from hot flash studies. J Clin Oncol. Dec 1 2001;19(23):4280-4290.||||0.0903
72531310|NCT01140646|144591907|SUPERIORITY_OR_OTHER|||||||0.1553||||||One sided t-test with 0.05 error rate was employed.|t-test, 1 sided|||To determine whether any reduction in hot flash frequency is beyond what is expected with a placebo (20-25%). Reference: Sloan JA, et al. Methodologic lessons learned from hot flash studies. J Clin Oncol. Dec 1 2001;19(23):4280-4290.||||0.1553
72572091|NCT02912650|144671813|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-11.7||||0.001|TWO_SIDED|95.0|-18.7|-4.7|||Cochran-Mantel-Haenszel|||3 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||-4.70|-18.70|0.001
72572092|NCT02912650|144671813|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-49.41|||<|0.001|TWO_SIDED|95.0|-63.21|-35.6|||Cochran-Mantel-Haenszel|||3 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||-35.60|-63.21|<0.001
72572093|NCT02912650|144671813|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-44.3|||<|0.001|TWO_SIDED|95.0|-58.04|-30.55|||Cochran-Mantel-Haenszel|||3 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||-30.55|-58.04|<0.001
72572094|NCT02912650|144671813|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-5.69||||0.151|TWO_SIDED|95.0|-13.46|2.08|||Cochran-Mantel-Haenszel|||3 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||2.08|-13.46|0.151
72572095|NCT02912650|144671813|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-56.94|||<|0.001|TWO_SIDED|95.0|-69.96|-43.91|||Cochran-Mantel-Haenszel|||4 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||-43.91|-69.96|<0.001
72572096|NCT02912650|144671813|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-9.0||||0.01|TWO_SIDED|95.0|-15.8|-2.19|||Cochran-Mantel-Haenszel|||4 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||-2.19|-15.80|0.010
72407990|NCT03551210|144324397|OTHER||Difference in percentage|4.3|||=|0.08|TWO_SIDED|95.0|-0.6|9.7|||Barnard's test|||Visit 2||9.7|-0.6|=0.08
72407991|NCT03551210|144324397|OTHER||Difference in percentage|3.7|||=|0.246|TWO_SIDED|95.0|-2.0|9.8|||Barnard's test|||Visit 3||9.8|-2.0|=0.246
72572097|NCT02912650|144671813|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-20.11|||<|0.001|TWO_SIDED|95.0|-27.97|-12.24|||Cochran-Mantel-Haenszel|||4 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||-12.24|-27.97|<0.001
72572098|NCT02912650|144671813|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-47.73|||<|0.001|TWO_SIDED|95.0|-61.64|-33.83|||Cochran-Mantel-Haenszel|||4 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||-33.83|-61.64|<0.001
72572099|NCT02912650|144671813|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-37.18|||<|0.001|TWO_SIDED|95.0|-50.96|-23.4|||Cochran-Mantel-Haenszel|||4 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||-23.40|-50.96|<0.001
72572100|NCT02912650|144671813|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-11.19||||0.013|TWO_SIDED|95.0|-20.02|-2.36|||Cochran-Mantel-Haenszel|||4 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||-2.36|-20.02|0.013
72572101|NCT02912650|144671813|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-58.14|||<|0.001|TWO_SIDED|95.0|-71.03|-45.26|||Cochran-Mantel-Haenszel|||5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||-45.26|-71.03|<0.001
72572102|NCT02912650|144671813|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-10.15||||0.005|TWO_SIDED|95.0|-17.24|-3.06|||Cochran-Mantel-Haenszel|||5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||-3.06|-17.24|0.005
72572103|NCT02912650|144671813|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-26.77|||<|0.001|TWO_SIDED|95.0|-35.1|-18.44|||Cochran-Mantel-Haenszel|||5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||-18.44|-35.10|<0.001
72572104|NCT02912650|144671813|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-47.74|||<|0.001|TWO_SIDED|95.0|-61.76|-33.72|||Cochran-Mantel-Haenszel|||5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||-33.72|-61.76|<0.001
72572105|NCT02912650|144671813|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-31.69|||<|0.001|TWO_SIDED|95.0|-45.61|-17.76|||Cochran-Mantel-Haenszel|||5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||-17.76|-45.61|<0.001
72572106|NCT02912650|144671813|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-16.76|||<|0.001|TWO_SIDED|95.0|-26.1|-7.42|||Cochran-Mantel-Haenszel|||5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||-7.42|-26.10|<0.001
72572107|NCT02912650|144671813|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-57.58|||<|0.001|TWO_SIDED|95.0|-70.44|-44.72|||Cochran-Mantel-Haenszel|||6 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||-44.72|-70.44|<0.001
72625781|NCT06378008|144781096|SUPERIORITY||Adjusted Mean Difference|-2.27|STANDARD_ERROR_OF_MEAN|3.859||0.5565|TWO_SIDED|95.0|-9.88|5.33|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as Test Toothpaste minus Reference Toothpaste.|Change from Baseline at Day 28||5.33|-9.88|0.5565
72407992|NCT03551210|144324398|OTHER||||||=|0.154|||||||Barnard test|||||||=0.154
72407993|NCT03551210|144324399|OTHER||||||=|0.14|||||||Log Rank|||||||=0.14
72572108|NCT02912650|144671813|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-11.28||||0.004|TWO_SIDED|95.0|-18.99|-3.57|||Cochran-Mantel-Haenszel|||6 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||-3.57|-18.99|0.004
72572109|NCT02912650|144671813|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-28.06|||<|0.001|TWO_SIDED|95.0|-36.77|-19.35|||Cochran-Mantel-Haenszel|||6 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||-19.35|-36.77|<0.001
72572110|NCT02912650|144671813|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-46.01|||<|0.001|TWO_SIDED|95.0|-59.98|-32.04|||Cochran-Mantel-Haenszel|||6 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||-32.04|-59.98|<0.001
72572111|NCT02912650|144671813|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-29.7|||<|0.001|TWO_SIDED|95.0|-43.65|-15.75|||Cochran-Mantel-Haenszel|||6 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||-15.75|-43.65|<0.001
72572112|NCT02912650|144671813|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-16.94|||<|0.001|TWO_SIDED|95.0|-26.59|-7.29|||Cochran-Mantel-Haenszel|||6 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||-7.29|-26.59|<0.001
72572113|NCT02912650|144671813|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-52.9|||<|0.001|TWO_SIDED|95.0|-66.06|-39.75|||Cochran-Mantel-Haenszel|||7 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||-39.75|-66.06|<0.001
72572114|NCT02912650|144671813|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-8.93||||0.042|TWO_SIDED|95.0|-17.53|-0.34|||Cochran-Mantel-Haenszel|||7 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||-0.34|-17.53|0.042
72625782|NCT06378008|144781096|SUPERIORITY||Adjusted Mean Difference|-5.96|STANDARD_ERROR_OF_MEAN|4.715||0.2078|TWO_SIDED|95.0|-15.25|3.34|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as Test Toothpaste minus Reference Toothpaste.|Change from Baseline at Day 56||3.34|-15.25|0.2078
72572115|NCT02912650|144671813|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-27.25|||<|0.001|TWO_SIDED|95.0|-36.65|-17.86|||Cochran-Mantel-Haenszel|||7 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||-17.86|-36.65|<0.001
72572116|NCT02912650|144671813|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-43.78|||<|0.001|TWO_SIDED|95.0|-57.83|-29.72|||Cochran-Mantel-Haenszel|||7 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||-29.72|-57.83|<0.001
72572117|NCT02912650|144671813|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-25.75|||<|0.001|TWO_SIDED|95.0|-39.93|-11.57|||Cochran-Mantel-Haenszel|||7 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||-11.57|-39.93|<0.001
72572118|NCT02912650|144671813|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-18.49|||<|0.001|TWO_SIDED|95.0|-28.39|-8.59|||Cochran-Mantel-Haenszel|||7 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||-8.59|-28.39|<0.001
72572119|NCT02912650|144671813|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-45.27|||<|0.001|TWO_SIDED|95.0|-58.96|-31.58|||Cochran-Mantel-Haenszel|||8 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||-31.58|-58.96|<0.001
72572120|NCT02912650|144671813|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-8.88||||0.064|TWO_SIDED|95.0|-18.27|0.5|||Cochran-Mantel-Haenszel|||8 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||0.50|-18.27|0.064
72572121|NCT02912650|144671813|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-26.98|||<|0.001|TWO_SIDED|95.0|-36.91|-17.05|||Cochran-Mantel-Haenszel|||8 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||-17.05|-36.91|<0.001
72572122|NCT02912650|144671813|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-36.26|||<|0.001|TWO_SIDED|95.0|-50.45|-22.07|||Cochran-Mantel-Haenszel|||8 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||-22.07|-50.45|<0.001
72572123|NCT02912650|144671813|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-18.58||||0.01|TWO_SIDED|95.0|-32.64|-4.52|||Cochran-Mantel-Haenszel|||8 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||-4.52|-32.64|0.010
72625783|NCT06378008|144781097|SUPERIORITY||Adjusted Mean Difference|-0.34|STANDARD_ERROR_OF_MEAN|0.588||0.5597|TWO_SIDED|95.0|-1.5|0.82|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as Test Toothpaste minus Reference Toothpaste.|Change from Baseline at Day 28||0.82|-1.50|0.5597
72625784|NCT06378008|144781097|SUPERIORITY||Adjusted Mean Difference|-0.52|STANDARD_ERROR_OF_MEAN|0.705||0.4627|TWO_SIDED|95.0|-1.91|0.87|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as Test Toothpaste minus Reference Toothpaste.|Change from Baseline at Day 56||0.87|-1.91|0.4627
72407994|NCT03551210|144324400|OTHER||||||=|0.26|||||||Barnard test|||||||=0.26
72531311|NCT03006276|144591912|SUPERIORITY||Odds Ratio (OR)|2.0|||<|0.001|TWO_SIDED|95.0|1.36|2.94|||Fisher Exact|||Last Observation Carried Forward (LOCF)||2.94|1.36|<0.001
72531312|NCT03006276|144591912|SUPERIORITY||Odds Ratio (OR)|1.97|||<|0.001|TWO_SIDED|95.0|1.34|2.89|||Fisher Exact|||||2.89|1.34|<0.001
72531313|NCT03006276|144591913|SUPERIORITY||Odds Ratio (OR)|1.68||||0.007|TWO_SIDED|95.0|1.17|2.43|||Fisher Exact|||last observation carried forward (LOCF)||2.43|1.17|0.007
72531314|NCT03006276|144591913|SUPERIORITY||Odds Ratio (OR)|1.69||||0.007|TWO_SIDED|95.0|1.16|2.44|||Fisher Exact|||observed cases (OC)||2.44|1.16|0.007
72531315|NCT03245372|144591929|SUPERIORITY|||||||0.114|||||||Wilcoxon (Mann-Whitney)|||||||0.114
72531316|NCT03245372|144591930|SUPERIORITY|||||||0.692|||||||Wilcoxon (Mann-Whitney)|||||||0.692
72531317|NCT03245372|144591931|SUPERIORITY|||||||0.082|||||||t-test, 2 sided|||||||0.082
72531318|NCT03245372|144591932|SUPERIORITY|||||||0.443|||||||Wilcoxon (Mann-Whitney)|||||||0.443
72625785|NCT06378008|144781098|SUPERIORITY||Adjusted Mean Difference|-1.64|STANDARD_ERROR_OF_MEAN|1.583||0.3|TWO_SIDED|95.0|-4.77|1.48|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as Test Toothpaste minus Reference Toothpaste.|Change from Baseline at Day 28||1.48|-4.77|0.3000
72531319|NCT03245372|144591933|SUPERIORITY|||||||0.668|||||||t-test, 2 sided|||||||0.668
72531320|NCT03245372|144591934|SUPERIORITY|||||||0.516|||||||Chi-squared|||||||0.516
72531321|NCT03245372|144591936|SUPERIORITY|||||||0.229|||||||Wilcoxon (Mann-Whitney)|||||||0.229
72531322|NCT03245372|144591937|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1
72531323|NCT00660829|144591940|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.5633|STANDARD_DEVIATION|0.3345|<|0.001||95.0|-2.22|-0.91|||ANCOVA|ANCOVA is being used due to a covariate being included in the model. The covariate is baseline TNSS score.||||-0.91|-2.22|<0.001
72531324|NCT00660829|144591941|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7444|STANDARD_ERROR_OF_MEAN|0.1677|<|0.001||95.0|-1.07|-0.42|||ANOVA|ANCOVA is being used due to a covariate being included in the model. The covariate is baseline TNSS score.||||-0.42|-1.07|<0.001
72531325|NCT00660829|144591942|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.4403|STANDARD_DEVIATION|0.3406|<|0.001||95.0|-2.11|-0.77|||ANCOVA|ANCOVA is being used due to a covariate being included in the model. The covariate is baseline TNSS score.||||-0.77|-2.11|<0.001
72531326|NCT00660829|144591943|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.2907|STANDARD_DEVIATION|0.3204|<|0.001||95.0|-1.92|0.66|||ANCOVA|ANCOVA is being used due to a covariate being included in the model. The covariate is baseline TNSS score.||Change in baseline||0.66|-1.92|<0.001
72407995|NCT03551210|144324401|OTHER||||||=|0.14||||||Visit 2 assessment|Barnard's test|||||||=0.14
72531327|NCT00660829|144591944|SUPERIORITY_OR_OTHER|||||||0.001|||||||ANCOVA|||Change from baseline||||0.001
72531328|NCT02127931|144591947|OTHER|||||||0.005|||||||Correlation|||ADHD-I||||0.005
72531329|NCT02127931|144591947|OTHER|||||||0.023|||||||Correlation|||ADHD-C||||0.023
72531330|NCT02127931|144591948|OTHER|||||||0.013|||||||Correlation|||||||0.013
72531331|NCT00679354|144591967|SUPERIORITY_OR_OTHER||Spearman's Correlation Coefficient|0.0||||1|TWO_SIDED||||||Spearman's Correlation|||||||1.000
72531332|NCT00679354|144591968|SUPERIORITY_OR_OTHER||Spearman's Correlation Coefficient|0.56||||0.057|TWO_SIDED||||||Spearman's Correlation|||||||0.057
72531333|NCT00679354|144591969|SUPERIORITY_OR_OTHER||Spearman's Correlation Coefficient|-0.22||||0.495|TWO_SIDED||||||Spearman's Correlation|||||||0.495
72531334|NCT00679354|144591970|SUPERIORITY_OR_OTHER||Spearman's Correlation Coefficient|-0.48||||0.114|TWO_SIDED||||||Spearman's Correlation|||||||0.114
72531335|NCT03947333|144591982|SUPERIORITY||Mean Difference (Final Values)|1.6||||0.221|TWO_SIDED||||||t-test, 1 sided|||||||0.221
72531336|NCT03947333|144591982|OTHER||fixed-effects estimate of intervention|0.846||||0.559|TWO_SIDED|95.0|-1.99|3.68|||Mixed Models Analysis|||Mixed effects model||3.68|-1.99|0.559
72531337|NCT03947333|144591983|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.532|TWO_SIDED||||||t-test, 1 sided|||||||0.532
72531338|NCT03947333|144591984|SUPERIORITY||Mean Difference (Final Values)|0.7||||0.086|TWO_SIDED||||||t-test, 1 sided|||Change at 3 months||||0.086
72531339|NCT03947333|144591984|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.562|TWO_SIDED||||||t-test, 1 sided|||Change at 6 months||||0.562
72531340|NCT03947333|144591984|OTHER||fixed-effects estimate of intervention|0.348||||0.451|TWO_SIDED|95.0|-0.557|1.254|||Mixed Models Analysis|||Mixed Effects Model||1.254|-0.557|0.451
72531341|NCT03947333|144591985|SUPERIORITY||Mean Difference (Final Values)|0.8||||0.27|TWO_SIDED||||||t-test, 1 sided|||Change at 3 months||||0.270
72531342|NCT03947333|144591985|SUPERIORITY||Mean Difference (Final Values)|0.7||||0.299|TWO_SIDED||||||t-test, 1 sided|||Change at 6 months||||0.299
72531343|NCT03947333|144591985|OTHER||fixed-effects estimate of intervention|0.1||||0.917|TWO_SIDED|95.0|-1.786|1.986|||Mixed Models Analysis|||Mixed effects model||1.986|-1.786|0.917
72531344|NCT03947333|144591986|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.093|TWO_SIDED||||||t-test, 1 sided|||Change at 3 months||||0.093
72531345|NCT03947333|144591986|SUPERIORITY||Mean Difference (Final Values)|0.4||||0.034|TWO_SIDED||||||t-test, 1 sided|||Change at 6 months||||0.034
72531346|NCT03947333|144591986|OTHER||fixed-effects estimate of intervention|0.242||||0.103|TWO_SIDED|95.0|-0.049|0.533|||Mixed Models Analysis|||Mixed Effects Model||0.533|-0.049|0.103
72531347|NCT03947333|144591987|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.116|TWO_SIDED||||||t-test, 1 sided|||Change at 3 months||||0.116
72531348|NCT03947333|144591987|SUPERIORITY||Mean Difference (Final Values)|0.4||||0.009|TWO_SIDED||||||t-test, 1 sided|||||||0.009
72531349|NCT03947333|144591987|OTHER||fixed-effects estimate of intervention|0.183||||0.178|TWO_SIDED|95.0|-0.084|0.451|||Mixed Models Analysis|||Mixed Effects Model||0.451|-0.084|0.178
72531350|NCT03947333|144591988|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.188|TWO_SIDED||||||t-test, 1 sided|||Change at 3 months||||0.188
72531351|NCT03947333|144591988|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.749|TWO_SIDED||||||t-test, 1 sided|||Change at 6 months||||0.749
72531352|NCT03947333|144591988|OTHER||fixed-effects estimate of intervention|0.031||||0.847|TWO_SIDED|95.0|-0.288|0.351|||Mixed Models Analysis|||Mixed Effects Model||0.351|-0.288|0.847
72531353|NCT03947333|144591989|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.182|TWO_SIDED||||||t-test, 1 sided|||Change at 3 months||||0.182
72531354|NCT03947333|144591989|SUPERIORITY||Mean Difference (Final Values)|0.3||||0.158|TWO_SIDED||||||t-test, 1 sided|||Change at 6 months||||0.158
72572124|NCT02912650|144671813|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-18.17|||<|0.001|TWO_SIDED|95.0|-28.44|-7.9|||Cochran-Mantel-Haenszel|||8 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||-7.90|-28.44|<0.001
72572125|NCT02912650|144671813|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-34.21|||<|0.001|TWO_SIDED|95.0|-48.21|-20.21|||Cochran-Mantel-Haenszel|||9 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||-20.21|-48.21|<0.001
72572126|NCT02912650|144671813|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-6.97||||0.179|TWO_SIDED|95.0|-17.12|3.19|||Cochran-Mantel-Haenszel|||9 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||3.19|-17.12|0.179
72572127|NCT02912650|144671813|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-20.7|||<|0.001|TWO_SIDED|95.0|-31.04|-10.35|||Cochran-Mantel-Haenszel|||9 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||-10.35|-31.04|<0.001
72572128|NCT02912650|144671813|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-27.2|||<|0.001|TWO_SIDED|95.0|-41.44|-12.96|||Cochran-Mantel-Haenszel|||9 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||-12.96|-41.44|<0.001
72625786|NCT06378008|144781098|SUPERIORITY||Adjusted Mean Difference|-2.53|STANDARD_ERROR_OF_MEAN|1.958||0.1974|TWO_SIDED|95.0|-6.39|1.33|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as Test Toothpaste minus Reference Toothpaste.|Change from Baseline at Day 56||1.33|-6.39|0.1974
72531355|NCT03947333|144591989|OTHER||fixed-effects estimate of intervention|0.107||||0.612|TWO_SIDED|95.0|-0.305|0.519|||Mixed Models Analysis|||Mixed Effects Model||0.519|-0.305|0.612
72625787|NCT06378008|144781099|SUPERIORITY||Adjusted Mean Difference|0.07|STANDARD_ERROR_OF_MEAN|0.679||0.9203|TWO_SIDED|95.0|-1.27|1.41|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as Test Toothpaste minus Reference Toothpaste.|Change from Baseline at Day 28||1.41|-1.27|0.9203
72625788|NCT06378008|144781099|SUPERIORITY||Adjusted Mean Difference|-0.83|STANDARD_ERROR_OF_MEAN|0.717||0.2489|TWO_SIDED|95.0|-2.24|0.58|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as Test Toothpaste minus Reference Toothpaste.|Change from Baseline at Day 56||0.58|-2.24|0.2489
72531356|NCT03947333|144591990|SUPERIORITY||Mean Difference (Final Values)|-0.5||||0.97|TWO_SIDED||||||t-test, 1 sided|||Change at 3 months||||0.970
72531357|NCT03947333|144591990|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.786|TWO_SIDED||||||t-test, 1 sided|||Change at 6 months||||0.786
72531358|NCT03947333|144591990|OTHER||fixed-effects estimate of intervention|-0.088||||0.67|TWO_SIDED|95.0|-0.493|0.317|||Mixed Models Analysis|||Mixed Effects Model||0.317|-0.493|0.670
72572129|NCT02912650|144671813|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-13.9||||0.051|TWO_SIDED|95.0|-27.84|0.04|||Cochran-Mantel-Haenszel|||9 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||0.04|-27.84|0.051
72572130|NCT02912650|144671813|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-13.76||||0.01|TWO_SIDED|95.0|-24.21|-3.31|||Cochran-Mantel-Haenszel|||9 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||-3.31|-24.21|0.010
72572131|NCT02912650|144671813|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-23.25||||0.001|TWO_SIDED|95.0|-37.31|-9.2|||Cochran-Mantel-Haenszel|||10 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||-9.20|-37.31|0.001
72572132|NCT02912650|144671813|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-2.22||||0.676|TWO_SIDED|95.0|-12.63|8.19|||Cochran-Mantel-Haenszel|||10 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||8.19|-12.63|0.676
72572133|NCT02912650|144671813|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-13.15||||0.013|TWO_SIDED|95.0|-23.57|-2.74|||Cochran-Mantel-Haenszel|||10 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||-2.74|-23.57|0.013
72572134|NCT02912650|144671813|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-20.94||||0.004|TWO_SIDED|95.0|-35.18|-6.69|||Cochran-Mantel-Haenszel|||10 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||-6.69|-35.18|0.004
72572135|NCT02912650|144671813|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-10.39||||0.14|TWO_SIDED|95.0|-24.19|3.4|||Cochran-Mantel-Haenszel|||10 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||3.40|-24.19|0.140
72572136|NCT02912650|144671813|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-11.06||||0.038|TWO_SIDED|95.0|-21.51|-0.61|||Cochran-Mantel-Haenszel|||10 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||-0.61|-21.51|0.038
72531359|NCT03947333|144591991|SUPERIORITY||Median Difference (Final Values)|0.0||||0.478|TWO_SIDED||||||t-test, 1 sided|||Change at 3 months||||0.478
72572137|NCT02912650|144671813|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-17.9||||0.013||95.0|-32.13|-3.79|||Cochran-Mantel-Haenszel|||11 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores||-3.79|-32.13|0.013
72625789|NCT06378008|144781100|SUPERIORITY||Adjusted Mean Difference|-0.21|STANDARD_ERROR_OF_MEAN|1.09||0.8496|TWO_SIDED|95.0|-2.36|1.94|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as Test Toothpaste minus Reference Toothpaste.|Change from Baseline at Day 28||1.94|-2.36|0.8496
72625790|NCT06378008|144781100|SUPERIORITY||Adjusted Mean Difference|-1.73|STANDARD_ERROR_OF_MEAN|1.226||0.1596|TWO_SIDED|95.0|-4.15|0.69|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as Test Toothpaste minus Reference Toothpaste.|Change from Baseline at Day 56||0.69|-4.15|0.1596
72531360|NCT03947333|144591991|SUPERIORITY||Mean Difference (Net)|-0.2||||0.666|TWO_SIDED||||||t-test, 1 sided|||Change at 6 months||||0.666
72531361|NCT03947333|144591991|OTHER||fixed-effects estimate of intervention|-0.15||||0.601|TWO_SIDED|95.0|-0.713|0.413|||Mixed Models Analysis|||Mixed Effects Model||0.413|-0.713|0.601
72531362|NCT03947333|144591992|SUPERIORITY||Mean Difference (Final Values)|0.06||||0.654|TWO_SIDED||||||t-test, 1 sided|||||||0.654
72531363|NCT03947333|144591993|SUPERIORITY||Mean Difference (Final Values)|-0.04||||0.485|TWO_SIDED||||||t-test, 1 sided|||||||0.485
72531364|NCT03947333|144591994|OTHER|||||||0.48|||||||McNemar|||||||0.480
72531365|NCT03947333|144591994|OTHER|||||||0.023|||||||McNemar|||||||0.023
72531366|NCT03947333|144591995|SUPERIORITY||Mean Difference (Final Values)|0.8||||0.542|TWO_SIDED||||||t-test, 1 sided|||||||0.542
72531367|NCT02898662|144592002|OTHER|The null hypothesis was that during the 52-week double-blind treatment period, the time to LOAC in the AZD1419 arm was equal to the corresponding time to LOAC in the placebo arm.|Hazard Ratio (HR)|1.05||||0.5722|TWO_SIDED|95.0|0.59|1.87||1-sided p-value|Regression, Cox||Hazard ratio \< 1 favours AZD1419 over placebo.|Comparison between groups for time to LOAC. Cox regression model analysis with age and gender included as covariates.||1.87|0.59|0.5722
72531368|NCT02898662|144592003|OTHER||Odds Ratio (OR)|1.86||||0.2006|TWO_SIDED|95.0|0.72|4.79||2-sided p-value|Generalized estimating equation analysis|||Comparison between groups for participants experiencing LOAC. Odds ratio was estimated using a generalized linear model based on a generalized estimating equation approach fitting treatment, visit and age and gender as covariates.||4.79|0.72|0.2006
72531369|NCT02898662|144592004|OTHER||LS Mean difference|-0.02||||0.8166|TWO_SIDED|95.0|-0.22|0.17||2-sided p-value|Repeated measures analysis|||Comparison between groups for ACQ-5 score. Repeated measures analysis.||0.17|-0.22|0.8166
72531370|NCT02898662|144592005|OTHER||LS Mean difference|-0.03||||0.8412|TWO_SIDED|95.0|-0.32|0.26||2-sided p-value|Repeated measures analysis|||Comparison between groups for asthma daily diary score. Repeated measures analysis.||0.26|-0.32|0.8412
72531371|NCT02898662|144592006|OTHER|The null hypothesis was that the time to moderate or severe exacerbation was not different between AZD1419 and placebo.|Hazard Ratio (HR)|0.8||||0.5477|TWO_SIDED|95.0|0.38|1.67||2-sided p-value|Regression, Cox||Hazard ratio \< 1 favours AZD1419 over placebo.|Comparison between groups for time to moderate or severe asthma exacerbation. Cox regression model analysis with age and gender included as covariates.||1.67|0.38|0.5477
72625791|NCT06378008|144781101|SUPERIORITY||Adjusted Mean Difference|0.04|STANDARD_ERROR_OF_MEAN|0.697||0.9577|TWO_SIDED|95.0|-1.34|1.41|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as Test Toothpaste minus Reference Toothpaste.|Change from Baseline at Day 28||1.41|-1.34|0.9577
72407996|NCT03551210|144324401|OTHER|||||||0.515||||||Visit 3 assessment|Barnard's test|||||||0.515
72407997|NCT03551210|144324401|OTHER|||||||0.515||||||Visit 4 assessment|Barnard's test|||||||0.515
72531372|NCT02898662|144592006|OTHER||Odds Ratio (OR)|0.88||||0.7294|TWO_SIDED|95.0|0.41|1.86||2-sided p-value|Generalized estimating equation analysis|||Comparison between groups for participants with moderate or severe asthma exacerbation. Odds ratio was estimated using a generalized linear model based on a generalized estimating equation approach fitting treatment and visit as covariates.||1.86|0.41|0.7294
72531373|NCT02898662|144592008|OTHER||LS Mean difference|0.06||||0.3764|TWO_SIDED|95.0|-0.08|0.2||2-sided p-value|Repeated measures analysis|||Comparison between groups for pre-BD FEV1. Repeated measures analysis.||0.20|-0.08|0.3764
72531374|NCT02898662|144592008|OTHER||LS Mean difference|-0.03||||0.7013|TWO_SIDED|95.0|-0.17|0.11||2-sided p-value|Repeated measures analysis|||Comparison between groups for post-BD FEV1. Repeated measures analysis.||0.11|-0.17|0.7013
72531375|NCT02898662|144592009|OTHER||LS Mean difference|-0.32||||0.9686|TWO_SIDED|95.0|-16.54|15.9||2-sided p-value|Repeated measures analysis|||Comparison between groups for PEF. Repeated measures analysis.||15.90|-16.54|0.9686
72531376|NCT02898662|144592010|OTHER||LS Mean difference|-2.02||||0.5403|TWO_SIDED|95.0|-8.55|4.52||2-sided p-value|Repeated measures analysis|||Comparison between groups for FeNO. Repeated measures analysis.||4.52|-8.55|0.5403
72531377|NCT03802331|144592011|OTHER|Relative bioavailability|Adjusted Geometric Mean Ratio T/R (%)|166.02|||||TWO_SIDED|90.0|143.17|192.53|||||The Adjusted Geometric Mean is adjusted by treatment. Geometric coefficient of variation (gCV) = 19.0.|This model included effects accounting for the following sources of variation: sequence, subjects within sequences, period, and treatment.||192.53|143.17|
72531378|NCT03802331|144592012|OTHER|Relative bioavailability|Ajusted Geometric Mean Ratio T/R (%)|235.5|||||TWO_SIDED|90.0|179.82|308.42|||||The Adjusted Geometric Mean is adjusted by treatment. Geometric coefficient of variation (gCV) = 35.4.|This model included effects accounting for the following sources of variation: sequence, subjects within sequences, period, and treatment.||308.42|179.82|
72531379|NCT03802331|144592013|OTHER|Relative bioavailability|Adjusted Geometric Mean Ratio T/R (%)|159.39|||||TWO_SIDED|90.0|140.11|181.34|||||The Adjusted Geometric Mean is adjusted by treatment. Geometric coefficient of variation (gCV) = 16.5.|This model included effects accounting for the following sources of variation: sequence, subjects within sequences, period, and treatment.||181.34|140.11|
72531380|NCT03432819|144592030|SUPERIORITY|Using an intent-to-treat approach, intervention efficacy was tested with a hierarchical linear repeated-measures regressions where responses came from either follow-up, and MEMS adherence from 5, 6, or 7 month measurements. Predictors were an indicator for study arm, baseline value, follow-up time-point, and covariates. Standard errors were adjusted for clustering at the individual-level (ultimate clustering methods). Covariates were socio-demographics associated with the outcome at p\>.05.|Mean Difference (Net)|9.24||||0.06|TWO_SIDED|95.0|-0.55|19.03|||Regression, Linear|||||19.03|-0.55|0.06
72531381|NCT03432819|144592031|SUPERIORITY|Using an intent-to-treat approach, intervention efficacy was tested with a hierarchical linear repeated-measures regressions where responses came from either follow-up, and MEMS adherence from 5, 6, or 7 month measurements. Predictors were an indicator for study arm, baseline value, follow-up time-point, and covariates. Standard errors were adjusted for clustering at the individual-level (ultimate clustering methods). Covariates were socio-demographics associated with the outcome at p\>.05.|Mean Difference (Final Values)|4.5||||0.02|TWO_SIDED|95.0|0.7|8.3|||Regression, Linear|||||8.30|0.70|0.02
72625792|NCT06378008|144781101|SUPERIORITY||Adjusted Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.748||0.8261|TWO_SIDED|95.0|-1.64|1.31|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as Test Toothpaste minus Reference Toothpaste.|Change from Baseline at Day 56||1.31|-1.64|0.8261
72531382|NCT03432819|144592032|SUPERIORITY|Using an intent-to-treat approach, intervention efficacy was tested with a hierarchical linear repeated-measures regressions where responses came from either follow-up, and MEMS adherence from 5, 6, or 7 month measurements. Predictors were an indicator for study arm, baseline value, follow-up time-point, and covariates. Standard errors were adjusted for clustering at the individual-level (ultimate clustering methods). Covariates were socio-demographics associated with the outcome at p\>.05.|Mean Difference (Final Values)|0.08||||0.39|TWO_SIDED|95.0|-0.1|0.26|||Regression, Linear|||||0.26|-0.10|0.39
72531383|NCT03432819|144592033|SUPERIORITY||Median Difference (Final Values)|-0.09||||0.54|TWO_SIDED|95.0|-0.37|0.2|||Regression, Linear|||Using an intent-to-treat approach, intervention efficacy was tested with a hierarchical linear repeated-measures regressions where responses came from either follow-up, and MEMS adherence from 5, 6, or 7 month measurements. Predictors were an indicator for study arm, baseline value, follow-up time-point, and covariates. Standard errors were adjusted for clustering at the individual-level (ultimate clustering methods). Covariates were socio-demographics associated with the outcome at p\>.05.||0.20|-0.37|0.54
72531384|NCT03432819|144592034|SUPERIORITY||Median Difference (Final Values)|-0.02||||0.81|TWO_SIDED|95.0|-0.18|0.14|||Regression, Linear|||Using an intent-to-treat approach, intervention efficacy was tested with a hierarchical linear repeated-measures regressions where responses came from either follow-up, and MEMS adherence from 5, 6, or 7 month measurements. Predictors were an indicator for study arm, baseline value, follow-up time-point, and covariates. Standard errors were adjusted for clustering at the individual-level (ultimate clustering methods). Covariates were socio-demographics associated with the outcome at p\>.05.||0.14|-0.18|0.81
72531385|NCT03432819|144592035|SUPERIORITY||Median Difference (Final Values)|-0.18||||0.06|TWO_SIDED|95.0|-0.37|0.01|||Regression, Linear|||Using an intent-to-treat approach, intervention efficacy was tested with a hierarchical linear repeated-measures regressions where responses came from either follow-up, and MEMS adherence from 5, 6, or 7 month measurements. Predictors were an indicator for study arm, baseline value, follow-up time-point, and covariates. Standard errors were adjusted for clustering at the individual-level (ultimate clustering methods). Covariates were socio-demographics associated with the outcome at p\>.05.||0.01|-0.37|0.06
72531386|NCT03432819|144592036|SUPERIORITY||Mean Difference (Final Values)|-0.33||||0.16|TWO_SIDED|95.0|-0.78|0.13|||Regression, Linear|||Using an intent-to-treat approach, intervention efficacy was tested with a hierarchical linear repeated-measures regressions where responses came from either follow-up, and MEMS adherence from 5, 6, or 7 month measurements. Predictors were an indicator for study arm, baseline value, follow-up time-point, and covariates. Standard errors were adjusted for clustering at the individual-level (ultimate clustering methods). Covariates were socio-demographics associated with the outcome at p\>.05.||0.13|-0.78|0.16
72531387|NCT03432819|144592037|SUPERIORITY||Mean Difference (Final Values)|-0.47||||0.02|TWO_SIDED|95.0|-0.84|-0.09|||Regression, Linear|||Using an intent-to-treat approach, intervention efficacy was tested with a hierarchical linear repeated-measures regressions where responses came from either follow-up, and MEMS adherence from 5, 6, or 7 month measurements. Predictors were an indicator for study arm, baseline value, follow-up time-point, and covariates. Standard errors were adjusted for clustering at the individual-level (ultimate clustering methods). Covariates were socio-demographics associated with the outcome at p\>.05.||-0.09|-0.84|0.02
72531388|NCT03432819|144592038|SUPERIORITY||Mean Difference (Final Values)|-0.08||||0.71|TWO_SIDED|95.0|-0.32|0.47|||Regression, Linear|||Using an intent-to-treat approach, intervention efficacy was tested with a hierarchical linear repeated-measures regressions where responses came from either follow-up, and MEMS adherence from 5, 6, or 7 month measurements. Predictors were an indicator for study arm, baseline value, follow-up time-point, and covariates. Standard errors were adjusted for clustering at the individual-level (ultimate clustering methods). Covariates were socio-demographics associated with the outcome at p\>.05.||0.47|-0.32|0.71
72531389|NCT03432819|144592039|SUPERIORITY||Mean Difference (Final Values)|-0.34||||0.1|TWO_SIDED|95.0|-0.73|0.06|||Regression, Linear|||Using an intent-to-treat approach, intervention efficacy was tested with a hierarchical linear repeated-measures regressions where responses came from either follow-up, and MEMS adherence from 5, 6, or 7 month measurements. Predictors were an indicator for study arm, baseline value, follow-up time-point, and covariates. Standard errors were adjusted for clustering at the individual-level (ultimate clustering methods). Covariates were socio-demographics associated with the outcome at p\>.05.||0.06|-0.73|0.10
72531390|NCT03223649|144592106|SUPERIORITY||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.035||0.005|TWO_SIDED|95.0|-0.17|-0.03||Unadjusted p-value|ANCOVA|Log-transformed value adjusted for: arcsine sqrt transformed % fat mass, pubertal stage (pre, early, or late), and basal analyte log transformed.||||-.03|-.17|0.005
72531391|NCT03223649|144592107|SUPERIORITY||Mean Difference (Final Values)|-0.011|STANDARD_ERROR_OF_MEAN|0.011||0.349|TWO_SIDED|95.0|-0.033|0.011||Unadjusted P-value|ANCOVA|Log-transformed value adjusted for: arcsine sqrt transformed % fat mass, pubertal stage (pre, early, or late), and basal analyte log transformed.||||0.011|-.033|0.349
72531392|NCT03223649|144592108|SUPERIORITY||Mean Difference (Final Values)|-0.043|STANDARD_ERROR_OF_MEAN|0.021||0.045|TWO_SIDED|95.0|-0.084|-0.002||Unadjusted p-value|ANCOVA|Log-transformed value adjusted for: arcsine sqrt transformed % fat mass, pubertal stage (pre, early, or late), and basal analyte log transformed.||||-.002|-.084|.045
72531393|NCT03223649|144592109|SUPERIORITY||Mean Difference (Final Values)|-0.019|STANDARD_ERROR_OF_MEAN|0.016||0.226|TWO_SIDED|95.0|-0.051|0.013||Unadjusted p-value|ANCOVA|Log-transformed value adjusted for: arcsine sqrt transformed % fat mass, pubertal stage (pre, early, or late), and basal analyte log transformed.||||0.013|-0.051|0.226
72531394|NCT03223649|144592110|SUPERIORITY||Mean Difference (Final Values)|-5.8|STANDARD_ERROR_OF_MEAN|0.545|<|0.001|TWO_SIDED|95.0|-6.884|-4.716|||t-test, 2 sided|||||-4.716|-6.884|<0.001
72531395|NCT03223649|144592111|SUPERIORITY||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.116||0.39|TWO_SIDED|95.0|-0.33|0.13|||t-test, 2 sided|||||0.130|-0.330|0.39
72531396|NCT03223649|144592112|SUPERIORITY||Mean Difference (Final Values)|0.021|STANDARD_ERROR_OF_MEAN|0.046||0.648|TWO_SIDED|95.0|-0.071|0.114|||ANCOVA|Dependent variable in Kcal log transformed, comparison adjusted for: age(y), lean mass(kg), fat mass(kg)||||0.114|-0.071|0.648
72531397|NCT03223649|144592113|SUPERIORITY||Mean Difference (Final Values)|0.834|STANDARD_ERROR_OF_MEAN|1.354||0.539|TWO_SIDED|95.0|-1.857|3.525|||ANCOVA|Adjusted for age (years)||||3.525|-1.857|0.539
72531398|NCT03223649|144592114|SUPERIORITY||Mean Difference (Final Values)|-1.06|STANDARD_ERROR_OF_MEAN|1.766||0.55|TWO_SIDED|95.0|-4.57|2.45|||ANCOVA|Adjusted for age (years)||||2.45|-4.57|0.550
72531399|NCT03223649|144592115|SUPERIORITY||Mean Difference (Final Values)|0.226|STANDARD_ERROR_OF_MEAN|0.681||0.741|TWO_SIDED|95.0|-1.127|1.579|||ANCOVA|Adjusted for age (years)||||1.579|-1.127|0.741
72531400|NCT04533204|144592116|SUPERIORITY||Mean Difference (Final Values)|18.47|||<|0.001|TWO_SIDED|95.0|12.28|24.67|||Mixed Models Analysis|||||24.67|12.28|<.001
72531401|NCT04533204|144592117|SUPERIORITY||Mean Difference (Final Values)|2.33||||0.004|TWO_SIDED|95.0|0.75|3.91||Performance on cued recall (error scores)|Mixed Models Analysis|||||3.91|.75|.004
72531402|NCT03982069|144592118|OTHER||||||<|0.001||||||All listed antigens|Chi-squared|||||||<0.001
72531403|NCT03982069|144592119|OTHER||||||<|0.001||||||All listed antigens|Chi-squared|||||||<0.001
72531404|NCT03982069|144592120|OTHER||||||<|0.001||||||Day 28 for all listed antigens|Chi-squared|||||||<0.001
72531405|NCT03982069|144592120|OTHER|||||||0.4||||||Day 0, A/H1N1-A/Brisbane|Chi-squared|||||||0.40
72531406|NCT03982069|144592120|OTHER|||||||0.36||||||Day 0 A/H1N1-A/Kansas egg grown virus|Chi-squared|||||||0.36
72531407|NCT03982069|144592120|OTHER|||||||0.08||||||Day 0 A/H1N1-A/Kansas cell grown virus|Chi-squared|||||||0.08
72531408|NCT03982069|144592120|OTHER|||||||0.91||||||Day 0 B/Victoria-B/Colorado|Chi-squared|||||||0.91
72531409|NCT03982069|144592120|OTHER|||||||0.31||||||Day 0 B/Yamagata-B/Phuket|Chi-squared|||||||0.31
72531410|NCT03982069|144592121|OTHER|||||||0.79||||||Day 0 A/H1N1-A/Brisbane|t-test, 2 sided|||||||0.79
72531411|NCT03982069|144592121|OTHER|||||||0.79||||||Day 0 A/H3N2-A/Kansas egg grown virus|t-test, 2 sided|||||||0.79
72625793|NCT06378008|144781102|SUPERIORITY||Adjusted Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.089||0.8895|TWO_SIDED|95.0|-0.19|0.16|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as Test Toothpaste minus Reference Toothpaste.|Change from Baseline at Day 28||0.16|-0.19|0.8895
72625794|NCT06378008|144781102|SUPERIORITY||Adjusted Mean Difference|0.02|STANDARD_ERROR_OF_MEAN|0.101||0.8083|TWO_SIDED|95.0|-0.17|0.22|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as Test Toothpaste minus Reference Toothpaste.|Change from Baseline at Day 56||0.22|-0.17|0.8083
72625795|NCT06378008|144781103|SUPERIORITY||Adjusted Mean Difference|0.12|STANDARD_ERROR_OF_MEAN|0.351||0.7362|TWO_SIDED|95.0|-0.57|0.81|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as Test Toothpaste minus Reference Toothpaste.|Change from Baseline at Day 28||0.81|-0.57|0.7362
72531412|NCT03982069|144592121|OTHER|||||||0.56||||||Day 0 A/H3N2-A/Kansas cell grown virus|t-test, 2 sided|||||||0.56
72531413|NCT03982069|144592121|OTHER|||||||0.95||||||Day 0 B/Victoria-B/Colorado|t-test, 2 sided|||||||0.95
72531414|NCT03982069|144592121|OTHER|||||||0.44||||||Day 0 B/Yamagata-B/Phuket|t-test, 2 sided|||||||0.44
72531415|NCT03982069|144592121|OTHER||||||<|0.001||||||Day 28 for all listed variables|t-test, 2 sided|||||||<0.001
72531416|NCT03982069|144592122|OTHER|||||||0.83|||||||Chi-squared|Day 0: A/H1N1-A/Hawaii66-egg based antigen||||||0.83
72531417|NCT03982069|144592122|OTHER|||||||0.79|||||||Chi-squared|Day 0: A/H1N1-A/Hawaii70-cell based antigen||||||0.79
72531418|NCT03982069|144592122|OTHER|||||||0.65|||||||Chi-squared|Day 0: A/H1N1-A/Delaware||||||0.65
72531419|NCT03982069|144592122|OTHER|||||||0.06|||||||Chi-squared|Day 0: A/H3N2-A/Hong Kong||||||0.06
72531420|NCT03982069|144592122|OTHER|||||||0.98|||||||Chi-squared|Day 0: B/Victoria-B/Washington||||||0.98
72531421|NCT03982069|144592122|OTHER|||||||0.24|||||||Chi-squared|Day 0: B/Yamagata-B/Phuket||||||0.24
72531422|NCT03982069|144592122|OTHER||||||<|0.01|||||||Chi-squared|Day 28: A/H1N1-A/Hawaii66-egg based antigen, A/H1N1-A/Hawaii70-cell based antigen, A/H1N1-A/Delaware, B/Victoria-B/Washington, B/Yamagata-B/Phuket||||||<0.01
72531423|NCT03982069|144592122|OTHER|||||||0.66|||||||Chi-squared|A/H3N2-A/Hong Kong||||||0.66
72531424|NCT03982069|144592123|OTHER|||||||0.22||||||Day 0: A/H1N1-A/Hawaii66 egg based antigen|t-test, 2 sided|||||||0.22
72531425|NCT03982069|144592123|OTHER|||||||0.25||||||Day 0: A/H1N1-A/Hawaii70 cell based antigen|t-test, 2 sided|||||||0.25
72531426|NCT03982069|144592123|OTHER|||||||0.13||||||Day 0: A/H1N1-A/Delaware|t-test, 2 sided|||||||0.13
72531427|NCT03982069|144592123|OTHER|||||||0.06||||||Day 0: A/H3N2-A/Hong Kong|t-test, 2 sided|||||||0.06
72531428|NCT03982069|144592123|OTHER|||||||0.78||||||Day 0: B/Victoria-B/Washington|t-test, 2 sided|||||||0.78
72531429|NCT03982069|144592123|OTHER|||||||0.36||||||Day 0: B/Yamagata-B/Phuket|t-test, 2 sided|||||||0.36
72531430|NCT03982069|144592123|OTHER||||||<|0.0001||||||Day 28: A/H1N1-A/Hawaii66 egg based antigen, A/H1N1-A/Hawaii70 cell based antigen, A/H1N1-A/Delaware, B/Victoria-B/Washington, B/Yamagata-B/Phuket|t-test, 2 sided|||||||<0.0001
72531431|NCT03982069|144592123|OTHER|||||||0.01||||||Day 28: A/H3N2-A/Hong Kong|t-test, 2 sided|||||||0.01
72531432|NCT03970330|144592132|SUPERIORITY||Mean Difference (Final Values)|1123.0||||0.2|TWO_SIDED|95.0|-755.0|3000.0|||t-test, 2 sided||Difference calculated as Naltrexone minus Placebo|||3000|-755|0.20
72531433|NCT03970330|144592133|SUPERIORITY||Mean Difference (Final Values)|28.9||||0.06|TWO_SIDED|95.0|-1.9|59.6|||Mixed Models Analysis|A single model was run with comparisons between naltrexone and placebo at each visit (not adjusted for multiple comparisons)|Difference calculated as Naltrexone minus Placebo|Comparison of treatment groups at BASELINE||59.6|-1.9|0.06
72531434|NCT03970330|144592133|SUPERIORITY||Mean Difference (Final Values)|10.4||||0.48|TWO_SIDED|95.0|-20.3|41.2|||Mixed Models Analysis|A single model was run with comparisons between naltrexone and placebo at each visit (not adjusted for multiple comparisons)|Difference calculated as Naltrexone minus Placebo|Comparison of treatment groups at WEEK 4||41.2|-20.3|0.48
72531435|NCT03970330|144592133|SUPERIORITY||Mean Difference (Final Values)|18.9||||0.21|TWO_SIDED|95.0|-11.8|49.6|||Mixed Models Analysis|A single model was run with comparisons between naltrexone and placebo at each visit (not adjusted for multiple comparisons)|Difference calculated as Naltrexone minus Placebo|Comparison of treatment groups at WEEK 8||49.6|-11.8|0.21
72531436|NCT03970330|144592133|SUPERIORITY||Mean Difference (Final Values)|15.5||||0.3|TWO_SIDED|95.0|-15.2|46.2|||Mixed Models Analysis|A single model was run with comparisons between naltrexone and placebo at each visit (not adjusted for multiple comparisons)|Difference calculated as Naltrexone minus Placebo|Comparison of treatment groups at WEEK 12||46.2|-15.2|0.30
72531437|NCT03970330|144592133|SUPERIORITY||Mean Difference (Final Values)|6.8||||0.65|TWO_SIDED|95.0|-24.0|37.5|||Mixed Models Analysis|A single model was run with comparisons between naltrexone and placebo at each visit (not adjusted for multiple comparisons)|Difference calculated as Naltrexone minus Placebo|Comparison of treatment groups at WEEK 16||37.5|-24.0|0.65
72531438|NCT03970330|144592134|SUPERIORITY|||||||0.07|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at WEEK 4||||0.07
72531439|NCT03970330|144592134|SUPERIORITY|||||||0.07|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at WEEK 8||||0.07
72531440|NCT03970330|144592134|SUPERIORITY|||||||0.06|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at WEEK 12||||0.06
72531441|NCT03970330|144592134|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at WEEK 16||||1.00
72531442|NCT03970330|144592135|SUPERIORITY|||||||0.29|||||||Wilcoxon (Mann-Whitney)|||Comparison of treament groups at WEEK 4||||0.29
72531443|NCT03970330|144592135|SUPERIORITY|||||||0.24|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at WEEK 8||||0.24
72531444|NCT03970330|144592135|SUPERIORITY|||||||0.2|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at WEEK 12||||0.20
72531445|NCT03970330|144592135|SUPERIORITY|||||||0.53|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at WEEK 16||||0.53
72531446|NCT03970330|144592136|SUPERIORITY|||||||0.37|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at WEEK 4||||0.37
72531447|NCT03970330|144592136|SUPERIORITY|||||||0.39|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at WEEK 8||||0.39
72531448|NCT03970330|144592136|SUPERIORITY|||||||0.37|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at WEEK 12||||0.37
72531449|NCT03970330|144592136|SUPERIORITY|||||||0.39|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at WEEK 16||||0.39
72531450|NCT03970330|144592137|SUPERIORITY||Mean Difference (Final Values)|4.3||||0.08|TWO_SIDED|95.0|-0.6|9.2|||t-test, 2 sided||Difference calculated as Naltrexone minus Placebo|||9.2|-0.6|0.08
72531451|NCT02242305|144592208|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.03||||0.809|TWO_SIDED|90.0|-0.33|0.27|||ANCOVA|Analysis of Covariance (ANCOVA) model including treatment and center as fixed effects and baseline pain intensity as a covariate was used.|Treatment differences were estimated by reference to the Least Squares (LS) mean differences within 3 days and the corresponding 90% CIs. The mean difference calculated as Hyoscine Butylbromide tablets 10 mg - Hyoscine Butylbromide capsules 10 mg.|||0.27|-0.33|0.809
72531452|NCT02242305|144592208|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.05||||0.809|TWO_SIDED|95.0|-0.39|0.33|||ANCOVA|Analysis of Covariance (ANCOVA) model including treatment and center as fixed effects and baseline pain intensity as a covariate was used.|Treatment differences were estimated by reference to the Least Squares (LS) mean differences within 1 day and the corresponding 90% CIs. The mean difference calculated as Hyoscine Butylbromide tablets 10 mg - Hyoscine Butylbromide capsules 10 mg.|||0.33|-0.39|0.809
72531453|NCT02242305|144592209|SUPERIORITY_OR_OTHER|||||||0.079|||||||ANCOVA|Analysis of Covariance (ANCOVA) model including treatment and center as fixed effects and baseline pain intensity as a covariate was used.||||||0.079
72531454|NCT02242305|144592214|SUPERIORITY_OR_OTHER|||||||0.531|||||||ANCOVA|Analysis of Covariance (ANCOVA) model including treatment and center as fixed effects and baseline score as covariates was used.||||||0.531
72531455|NCT03451630|144592215|SUPERIORITY|||||||0.0211||||||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 2.49 with degrees of freedom (6, 3152).||Overall Test of Group by Time Interaction||||0.0211
72531456|NCT03451630|144592215|SUPERIORITY||Mean Difference (Final Values)|2.69|STANDARD_ERROR_OF_MEAN|1.22||0.028|TWO_SIDED|95.0|0.29|5.09||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 4.83 with degrees of freedom (1, 3152).||Test for group difference in the change from baseline to 12-Months using linear contrast.||5.09|0.29|0.0280
72531457|NCT03451630|144592215|SUPERIORITY||Mean Difference (Final Values)|2.07|STANDARD_ERROR_OF_MEAN|1.23||0.0935|TWO_SIDED|95.0|-0.35|4.48||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 2.81 with degrees of freedom (1, 3152).||Test for group difference in the change from baseline to 12-Months using linear contrast.||4.48|-0.35|0.0935
72531458|NCT03451630|144592215|SUPERIORITY||Mean Difference (Final Values)|0.62|STANDARD_ERROR_OF_MEAN|1.05||0.5538|TWO_SIDED|95.0|-1.44|2.68||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 0.35 with degrees of freedom (1, 3152).||Test for group difference in the change from baseline to12-Months using linear contrast.||2.68|-1.44|0.5538
72531459|NCT03451630|144592216|SUPERIORITY|Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).||||||0.8505|||||||Mixed Models Analysis|F-statistics 0.44 with degrees of freedom (6, 3154).||Overall Test of the Group by Time Interaction||||0.8505
72531460|NCT03451630|144592216|SUPERIORITY||||||<|0.0001||||||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 16.97 with degrees of freedom (3, 3160).||Test for significant change over time when the treatment-by-time interaction effect is not significant.||||<0.0001
72531461|NCT03451630|144592216|SUPERIORITY|||||||0.8656||||||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 0.14 with degrees of freedom (2, 1229).||Test for significant change by treatment when the treatment-by-time interaction effect is not significant.||||0.8656
72625796|NCT06378008|144781103|SUPERIORITY||Adjusted Mean Difference|-0.23|STANDARD_ERROR_OF_MEAN|0.39||0.5568|TWO_SIDED|95.0|-1.0|0.54|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as Test Toothpaste minus Reference Toothpaste.|Change from Baseline at Day 56||0.54|-1.00|0.5568
72572138|NCT02912650|144671813|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-3.85||||0.467||95.0|-14.23|6.53|||Cochran-Mantel-Haenszel|||11 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||6.53|-14.23|0.467
72531462|NCT03451630|144592216|SUPERIORITY||Mean Difference (Final Values)|0.93|STANDARD_ERROR_OF_MEAN|1.29||0.474|TWO_SIDED|95.0|-1.61|3.46||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 0.51 with degrees of freedom (1, 3154)||Test for group difference in the change from baseline to 12-Months using the linear contrasts.||3.46|-1.61|0.4740
72572139|NCT02912650|144671813|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-10.38||||0.049||95.0|-20.73|-0.02|||Cochran-Mantel-Haenszel|||11 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||-0.02|-20.73|0.049
72572140|NCT02912650|144671813|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-14.1||||0.05||95.0|-28.22|0.02|||Cochran-Mantel-Haenszel|||11 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||0.02|-28.22|0.050
72572141|NCT02912650|144671813|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-7.99||||0.255||95.0|-21.73|5.76|||Cochran-Mantel-Haenszel|||11 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores||5.76|-21.73|0.255
72572142|NCT02912650|144671813|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-6.57||||0.212||95.0|-16.89|3.75|||Cochran-Mantel-Haenszel|||11 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||3.75|-16.89|0.212
72625797|NCT00210132|144781104|SUPERIORITY|||||||0.99|||||||Fisher Exact|||Comparison of proportions.||||0.99
72572143|NCT02912650|144671813|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-15.68||||0.027||95.0|-29.59|-1.77|||Cochran-Mantel-Haenszel|||12 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores||-1.77|-29.59|0.027
72572144|NCT02912650|144671813|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-4.39||||0.399|TWO_SIDED|95.0|-14.59|5.82|||Cochran-Mantel-Haenszel|||12 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||5.82|-14.59|0.399
72572145|NCT02912650|144671813|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-7.5||||0.152||95.0|-17.76|2.77|||Cochran-Mantel-Haenszel|||12 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||2.77|-17.76|0.152
72572146|NCT02912650|144671813|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-11.32||||0.106|TWO_SIDED|95.0|-25.05|2.4|||Cochran-Mantel-Haenszel|||12 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||2.40|-25.05|0.106
72572147|NCT02912650|144671813|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-8.59||||0.21||95.0|-22.0|4.83|||Cochran-Mantel-Haenszel|||12 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||4.83|-22.00|0.210
72572148|NCT02912650|144671813|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-3.13||||0.545||95.0|-13.26|7.0|||Cochran-Mantel-Haenszel|||12 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||7.00|-13.26|0.545
72572149|NCT02912650|144671814|SUPERIORITY_OR_OTHER||CMH adjusted proportions|20.74|||<|0.001|TWO_SIDED|95.0|10.54|30.94|||Cochran-Mantel-Haenszel|||0.25 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||30.94|10.54|<0.001
72572150|NCT02912650|144671814|SUPERIORITY_OR_OTHER||CMH adjusted proportions|4.52||||0.342|TWO_SIDED|95.0|-4.81|13.86|||Cochran-Mantel-Haenszel|||0.25 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||13.86|-4.81|0.342
72572151|NCT02912650|144671814|SUPERIORITY_OR_OTHER||CMH adjusted proportions|3.62||||0.459|TWO_SIDED|95.0|-5.98|13.22|||Cochran-Mantel-Haenszel|||0.25 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||13.22|-5.98|0.459
72572152|NCT02912650|144671814|SUPERIORITY_OR_OTHER||CMH adjusted proportions|16.2||||0.001|TWO_SIDED|95.0|6.24|26.17|||Cochran-Mantel-Haenszel|||0.25 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||26.17|6.24|0.001
72572153|NCT02912650|144671814|SUPERIORITY_OR_OTHER||CMH adjusted proportions|17.37|||<|0.001|TWO_SIDED|95.0|7.42|27.31|||Cochran-Mantel-Haenszel|||0.25 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||27.31|7.42|<0.001
72625798|NCT00210132|144781105|SUPERIORITY|||||||0.69|||||||Wilcoxon (Mann-Whitney)|||||||0.69
72625799|NCT01561469|144781106|SUPERIORITY_OR_OTHER|||||||0.009|TWO_SIDED||||||Regression, Logistic|||||||0.009
72625800|NCT01561469|144781107|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Chi-squared|||Analysis for superinfections category reported.||||1.00
72625801|NCT01561469|144781107|SUPERIORITY_OR_OTHER|||||||0.759|TWO_SIDED||||||Chi-squared|||Analysis for colonization category reported.||||0.759
72625802|NCT01561469|144781108|SUPERIORITY_OR_OTHER|||||||0.773|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.773
72531463|NCT03451630|144592216|SUPERIORITY||Mean Difference (Final Values)|0.66|STANDARD_ERROR_OF_MEAN|1.26||0.6017|TWO_SIDED|95.0|-1.81|3.13||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 0.27 with degrees of freedom (1, 3154).||Test for group difference in the change from baseline to 12-Months using the linear contrasts.||3.13|-1.81|0.6017
72531464|NCT03451630|144592216|SUPERIORITY||Mean Difference (Final Values)|0.27|STANDARD_ERROR_OF_MEAN|0.99||0.786|TWO_SIDED|95.0|-1.67|2.2||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 0.07 with degrees of freedom (1, 3154).||Test for group difference in the change from baseline to 12-Months using the linear contrasts.||2.20|-1.67|0.7860
72531465|NCT03451630|144592217|SUPERIORITY|||||||0.59||||||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Regression, Logistic|Chi-squared statistics 0.08 with degrees of freedom (2).||Overall Test of Marginal Group Differences||||0.59
72531466|NCT03451630|144592217|SUPERIORITY||Odds Ratio (OR)|1.26||||0.6692|TWO_SIDED|95.0|0.76|2.11||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Regression, Logistic|Chi-square statistics 0.8 with degrees of freedom (2).||Test for the Treatment Effect||2.11|0.76|0.6692
72531467|NCT03451630|144592217|SUPERIORITY||Odds Ratio (OR)|1.16||||0.6692|TWO_SIDED|95.0|0.7|1.93||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Regression, Logistic|Chi-square statistics 0.80 with degrees of freedom (2).||Test for the Treatment Effect||1.93|0.70|0.6692
72531468|NCT03451630|144592217|SUPERIORITY||Odds Ratio (OR)|1.09||||0.6692|TWO_SIDED|95.0|0.75|1.59||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Regression, Logistic|Chi-square statistics 0.8 with degrees of freedom (2).||Test for the Treatment Effect||1.59|0.75|0.6692
72531469|NCT03451630|144592218|SUPERIORITY|||||||0.58||||||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Regression, Logistic|Chi-squared statistics 0.08 with degrees of freedom (2).||Overall Test of Marginal Group Differences||||0.58
72531470|NCT03451630|144592218|SUPERIORITY||Odds Ratio (OR)|1.13||||0.7436|TWO_SIDED|95.0|0.43|3.02||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Regression, Logistic|Chi-squared statistics 0.59 with degrees of freedom (2).||Test for the treatment effect||3.02|0.43|0.7436
72531471|NCT03451630|144592218|SUPERIORITY||Odds Ratio (OR)|0.84||||0.7436|TWO_SIDED|95.0|0.31|2.25||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Regression, Logistic|Chi-squared statistics 0.59 with degrees of freedom (2).||Test for the treatment effect.||2.25|0.31|0.7436
72531472|NCT03451630|144592218|SUPERIORITY||Odds Ratio (OR)|1.36||||0.7436|TWO_SIDED|95.0|0.62|2.97|||Regression, Logistic|Chi-squared statistics 0.59 with degrees of freedom (2).||Test for the treatment effect.||2.97|0.62|0.7436
72625803|NCT01561469|144781109|SUPERIORITY_OR_OTHER|||||||0.823|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.823
72531473|NCT03451630|144592219|SUPERIORITY|||||||0.5558||||||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 0.82 with degrees of freedom (6, 3057)||Overall test of treatment-by-time interaction||||0.5558
72531474|NCT03451630|144592219|SUPERIORITY|||||||0.0002||||||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 6.74 with degrees of freedom (3, 3063).||Test for the change over time when the treatment-by-time interaction effect is not significant.||||0.0002
72531475|NCT03451630|144592219|SUPERIORITY|||||||0.7846||||||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 0.24 with degrees of freedom (2,1197).||Test for the change by treatment when the treatment-by-time interaction effect is not significant.||||0.7846
72625804|NCT01561469|144781110|SUPERIORITY_OR_OTHER|||||||0.276|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.276
72625805|NCT01561469|144781111|SUPERIORITY_OR_OTHER|||||||0.512|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.512
72625806|NCT03189719|144781123|SUPERIORITY||Hazard Ratio (HR)|0.57|||<|0.0001|TWO_SIDED|95.0|0.43|0.75|||Stratified Log-Rank|||OS in ESCC PD-L1 CPS ≥10 participants of the pembrolizumab + SOC arm was compared to OS in ESCC PD-L1 CPS ≥10 participants of the placebo + SOC arm based on a Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by geographic region (Asia versus Rest of the World) and ECOG performance status (0 versus 1).||0.75|0.43|<0.0001
72625807|NCT03189719|144781124|SUPERIORITY||Hazard Ratio (HR)|0.72||||0.0006|TWO_SIDED|95.0|0.6|0.88|||Stratified Log-Rank|||OS in ESCC participants of the pembrolizumab + SOC arm was compared to OS in ESCC participants of the placebo + SOC arm based on a Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by geographic region (Asia versus Rest of the World) and ECOG performance status (0 versus 1).||0.88|0.60|0.0006
72625808|NCT03189719|144781125|SUPERIORITY||Hazard Ratio (HR)|0.62|||<|0.0001|TWO_SIDED|95.0|0.49|0.78|||Stratified Log-Rank|||OS in PD-L1 CPS ≥10 participants of the pembrolizumab + SOC arm was compared to OS in PD-L1 CPS ≥10 participants of the placebo + SOC arm based on a Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by geographic region (Asia versus Rest of the World) and tumor histology (Adenocarcinoma versus Squamous Cell Carcinoma).||0.78|0.49|<0.0001
72531476|NCT03451630|144592219|SUPERIORITY||Mean Difference (Final Values)|-0.71|STANDARD_ERROR_OF_MEAN|0.61||0.2444|TWO_SIDED|95.0|-1.92|0.49||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-Statistics 1.36 with degrees of freedom (1, 3057).||Test for Group difference in the change from baseline to 12 months using the linear contrasts.||0.49|-1.92|0.2444
72531477|NCT03451630|144592219|SUPERIORITY||Mean Difference (Final Values)|-0.28|STANDARD_ERROR_OF_MEAN|0.61||0.648|TWO_SIDED|95.0|-1.48|0.92||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 0.21 with degrees of freedom (1, 3057).||Test for Group difference in the change from baseline to 12 months using the linear contrasts.||0.92|-1.48|0.6480
72531478|NCT03451630|144592219|SUPERIORITY||Mean Difference (Final Values)|-0.44|STANDARD_ERROR_OF_MEAN|0.46||0.3476|TWO_SIDED|95.0|-1.34|0.47||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 0.88 with degrees of freedom (1, 3057).||Test for Group difference in the change from baseline to 12 months using the linear contrasts.||0.47|-1.34|0.3476
72531479|NCT03451630|144592220|SUPERIORITY|||||||0.5199||||||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 0.86 with degrees of freedom (6, 3148)||Overall test of treatment-by-time||||0.5199
72531480|NCT03451630|144592220|SUPERIORITY|||||||0.0008||||||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 5.56 with degrees of freedom (3, 3154).||Test for the change over time when the treatment-by-time interaction effect is not significant.||||0.0008
72531481|NCT03451630|144592220|SUPERIORITY|||||||0.9897||||||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 0.01 with degrees of freedom (2,1229).||Test for the change by treatment when the treatment-by-time interaction effect is not significant.||||0.9897
72407998|NCT03238911|144324420|SUPERIORITY||Risk Difference (RD)|-67.0|||<|0.0001|TWO_SIDED|95.0|-77.4|-51.5|||Cochran-Mantel-Haenszel||Iron isomaltoside/ferric derisomaltose was compared to ferric carboxymaltose by estimation of the risk difference and the associated 95% CI, adjusting for strata (underlying disease and screening s-phosphate) using the Cochran-Mantel-Haenszel method.|"Power:~The power was set to 80%. Assuming incidences of 15% for iron isomaltoside/ferric derisomaltose and 40% for ferric carboxymaltose, 49 subjects in each treatment group were required to detect a difference between the treatment groups. The significance level was set to 5%."||-51.5|-77.4|<0.0001
72531482|NCT03451630|144592220|SUPERIORITY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.01||0.8749|TWO_SIDED|95.0|-0.03|0.03||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 0.02 with degrees of freedom (1, 3148).||Test for Group difference in the change from baseline to 12 months using the linear contrasts.||0.03|-0.03|0.8749
72531483|NCT03451630|144592220|SUPERIORITY||Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.01||0.2216|TWO_SIDED|95.0|-0.05|0.01||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 1.49 with degrees of freedom (1, 3148).||Test for Group difference in the change from baseline to 12 months using the linear contrasts.||0.01|-0.05|0.2216
72531484|NCT03451630|144592220|SUPERIORITY||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.01||0.0607|TWO_SIDED|95.0|0.0|0.04||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 3.52 with degrees of freedom (1, 3148).||Test for Group difference in the change from baseline to 12 months using the linear contrasts.||0.04|0.00|0.0607
72531485|NCT03451630|144592221|SUPERIORITY|||||||0.1884||||||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 1.46 with degrees of freedom (6, 3138)||Overall test of treatment-by-time||||0.1884
72407999|NCT03238911|144324421|SUPERIORITY|||||||0.8979|||||||Log Rank|||The time with hypophosphatemia from baseline to day 35 was estimated by a Kaplan-Meier plot. The treatment groups were compared by a log-rank test. Only subjects who had one or more s-phosphate value(s) \<2 mg/dL were included.||||0.8979
72625809|NCT03189719|144781126|SUPERIORITY||Hazard Ratio (HR)|0.73|||<|0.0001|TWO_SIDED|95.0|0.62|0.86|||Stratified Log-Rank|||OS in all participants of the pembrolizumab + SOC arm was compared to OS in all participants of the placebo + SOC arm based on a Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by geographic region (Asia versus Rest of the World), tumor histology (Adenocarcinoma versus Squamous Cell Carcinoma), and ECOG performance status (0 versus 1).||0.86|0.62|<0.0001
72625810|NCT03189719|144781127|SUPERIORITY||Hazard Ratio (HR)|0.65|||<|0.0001|TWO_SIDED|95.0|0.54|0.78|||Stratified Log-Rank|||PFS in ESCC participants of the pembrolizumab + SOC arm was compared to PFS in ESCC participants of the placebo + SOC arm based on a Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by geographic region (Asia versus Rest of the World) and ECOG performance status (0 versus 1).||0.78|0.54|<0.0001
72625811|NCT03189719|144781128|SUPERIORITY||Hazard Ratio (HR)|0.51|||<|0.0001|TWO_SIDED|95.0|0.41|0.65|||Stratified Log-Rank|||PFS in PD-L1 CPS ≥10 participants of the pembrolizumab + SOC arm was compared to PFS in PD-L1 CPS ≥10 participants of the placebo + SOC arm based on a Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by geographic region (Asia versus Rest of the World) and tumor histology (Adenocarcinoma versus Squamous Cell Carcinoma).||0.65|0.41|<0.0001
72625812|NCT03189719|144781129|SUPERIORITY||Hazard Ratio (HR)|0.65|||<|0.0001|TWO_SIDED|95.0|0.55|0.76|||Stratified Log-Rank|||PFS in all participants of the pembrolizumab + SOC arm was compared to PFS in all participants of the placebo + SOC arm based on a Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by geographic region (Asia versus Rest of the World), tumor histology (Adenocarcinoma versus Squamous Cell Carcinoma), and ECOG performance status (0 versus 1).||0.76|0.55|<0.0001
72625813|NCT03189719|144781130|SUPERIORITY||Difference in Percentage|15.8|||<|0.0001|TWO_SIDED|95.0|9.0|22.5|||One-sided p-value|||ORR in all participants of the pembrolizumab + SOC arm was compared to ORR in all participants of the placebo + SOC arm based on the Miettinen \& Nurminen method stratified by geographic region (Asia versus Rest of the World), tumor histology (Adenocarcinoma versus Squamous Cell Carcinoma), and ECOG performance status (0 versus 1).||22.5|9.0|<0.0001
72625814|NCT03189719|144781131|OTHER||Difference in Percentage|22.8|||<|0.0001|TWO_SIDED|95.0|11.6|33.4|||One-sided p-value|||ORR in ESCC PD-L1 CPS ≥10 participants of the pembrolizumab + SOC arm was compared to ORR in ESCC PD-L1 CPS ≥10 participants of the placebo + SOC arm based on the Miettinen \& Nurminen method stratified by geographic region (Asia versus Rest of the World) and ECOG performance status (0 versus 1).||33.4|11.6|<0.0001
72625815|NCT03189719|144781132|OTHER||Difference in Percentage|12.8||||0.0009|TWO_SIDED|95.0|4.7|20.7|||One-sided p-value|||ORR in ESCC participants of the pembrolizumab + SOC arm was compared to ORR in ESCC participants of the placebo + SOC arm based on the Miettinen \& Nurminen method stratified by geographic region (Asia versus Rest of the World) and ECOG performance status (0 versus 1).||20.7|4.7|0.0009
72625816|NCT03189719|144781133|OTHER||Difference in Percentage|24.0|||<|0.0001|TWO_SIDED|95.0|14.3|33.2|||One-sided p-value|||ORR in PD-L1 CPS ≥10 participants of the pembrolizumab + SOC arm was compared to ORR in PD-L1 CPS ≥10 participants of the placebo + SOC arm based on the Miettinen \& Nurminen method stratified by geographic region (Asia versus Rest of the World) and tumor histology (Adenocarcinoma versus Squamous Cell Carcinoma).||33.2|14.3|<0.0001
72625817|NCT03189719|144781140|OTHER||Difference in LS Means|-0.1||||0.953|TWO_SIDED|95.0|-3.4|3.2|||constrained Longitudinal Data Analysis|||Change from baseline to Week 18 in EORTC-QLQ-C30 GHS/QoL combined score was compared between treatment arms based on a constrained longitudinal data analysis (cLDA) model with the EORTC-QLQ-C30 GHS/QoL scores as the response variable with covariates for treatment by study visit interaction, and stratification factors including geographic region (Asia versus Rest of the World) and tumor histology (Adenocarcinoma versus Squamous Cell Carcinoma) and ECOG performance status (0 versus 1).||3.20|-3.40|0.9530
72625818|NCT03189719|144781141|OTHER||Difference in LS Means|-1.95||||0.5053|TWO_SIDED|95.0|-7.72|3.82|||constrained Longitudinal Data Analysis|||Change from baseline to Week 18 in EORTC-QLQ-C30 GHS/QoL combined score was compared between treatment arms based on a cLDA model with the EORTC-QLQ-C30 GHS/QoL scores as the response variable with covariates for treatment by study visit interaction, and stratification factors including geographic region (Asia versus Rest of the World) and ECOG performance status (0 versus 1).||3.82|-7.72|0.5053
72625819|NCT03189719|144781142|OTHER||Difference in LS Means|-0.06||||0.9742|TWO_SIDED|95.0|-3.93|3.81|||constrained Longitudinal Data Analysis|||Change from baseline to Week 18 in EORTC-QLQ-C30 GHS/QoL combined score was compared between treatment arms based on a cLDA model with the EORTC-QLQ-C30 GHS/QoL scores as the response variable with covariates for treatment by study visit interaction, and stratification factors including geographic region (Asia versus Rest of the World) and ECOG performance status (0 versus 1).||3.81|-3.93|0.9742
72625820|NCT03189719|144781143|OTHER||Difference in LS Means|-1.77||||0.481|TWO_SIDED|95.0|-6.71|3.17|||constrained Longitudinal Data Analysis|||Change from baseline to Week 18 in EORTC-QLQ-C30 GHS/QoL combined score was compared between treatment arms based on a cLDA model with the EORTC-QLQ-C30 GHS/QoL scores as the response variable with covariates for treatment by study visit interaction, and stratification factors including geographic region (Asia versus Rest of the World) and tumor histology (Adenocarcinoma versus Squamous Cell Carcinoma).||3.17|-6.71|0.4810
72572154|NCT02912650|144671814|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-0.91||||0.849|TWO_SIDED|95.0|-10.2|8.42|||Cochran-Mantel-Haenszel|||0.25 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||8.42|-10.2|0.849
72572155|NCT02912650|144671814|SUPERIORITY_OR_OTHER||CMH adjusted proportions|51.08|||<|0.001|TWO_SIDED|95.0|39.53|62.62|||Cochran-Mantel-Haenszel|||0.5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||62.62|39.53|<0.001
72572156|NCT02912650|144671814|SUPERIORITY_OR_OTHER||Cumulative Percentage of Participants wi|5.16||||0.318|TWO_SIDED|95.0|-4.97|15.3|||Cochran-Mantel-Haenszel|||0.5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||15.30|-4.97|0.318
72625821|NCT03189719|144781144|OTHER||Difference in LS Means|-5.54||||0.0436|TWO_SIDED|95.0|-10.93|-0.16|||constrained Longitudinal Data Analysis|||DYSPHAGIA: Change from baseline to Week 18 in EORTC QLQ-OES18 Dysphagia subscale was compared between treatment arms based on a cLDA model with EORTC QLQ-OES18 scores as the response variable with covariates for treatment by study visit interaction, and stratification factors including geographic region (Asia versus Rest of the World) and tumor histology (Adenocarcinoma versus Squamous Cell Carcinoma) and ECOG performance status (0 versus 1).||-0.16|-10.93|0.0436
72625822|NCT03189719|144781144|OTHER||Difference in LS Means|-2.94||||0.0487|TWO_SIDED|95.0|-5.86|-0.02|||constrained Longitudinal Data Analysis|||PAIN: Change from baseline to Week 18 in EORTC QLQ-OES18 Pain subscale was compared between treatment arms based on a cLDA model with EORTC QLQ-OES18 scores as the response variable with covariates for treatment by study visit interaction, and stratification factors including geographic region (Asia versus Rest of the World) and tumor histology (Adenocarcinoma versus Squamous Cell Carcinoma) and ECOG performance status (0 versus 1).||-0.02|-5.86|0.0487
72572157|NCT02912650|144671814|SUPERIORITY_OR_OTHER||CMH adjusted proportions|9.86||||0.062|TWO_SIDED|95.0|-0.49|20.21|||Cochran-Mantel-Haenszel|||0.5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||20.21|-0.49|0.062
72572158|NCT02912650|144671814|SUPERIORITY_OR_OTHER||CMH adjusted proportions|45.6|||<|0.001|TWO_SIDED|95.0|33.45|57.76|||Cochran-Mantel-Haenszel|||0.5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||57.76|33.45|<0.001
72625823|NCT03189719|144781144|OTHER||Difference in LS Means|-0.93||||0.5932|TWO_SIDED|95.0|-4.36|2.49|||constrained Longitudinal Data Analysis|||REFLUX: Change from baseline to Week 18 in EORTC QLQ-OES18 Reflux subscale was compared between treatment arms based on a cLDA model with EORTC QLQ-OES18 scores as the response variable with covariates for treatment by study visit interaction, and stratification factors including geographic region (Asia versus Rest of the World) and tumor histology (Adenocarcinoma versus Squamous Cell Carcinoma) and ECOG performance status (0 versus 1).||2.49|-4.36|0.5932
72625824|NCT03189719|144781145|OTHER||Difference in LS Means|-8.68||||0.0564|TWO_SIDED|95.0|-17.59|0.24|||constrained Longitudinal Data Analysis|||DYSPHAGIA: Change from baseline to Week 18 in EORTC QLQ-OES18 Dysphagia subscale was compared between treatment arms based on a cLDA model with EORTC QLQ-OES18 scores as the response variable with covariates for treatment by study visit interaction, and stratification factors including geographic region (Asia versus Rest of the World) and ECOG performance status (0 versus 1).||0.24|-17.59|0.0564
72625825|NCT03189719|144781145|OTHER||Difference in LS Means|-2.13||||0.3813|TWO_SIDED|95.0|-6.93|2.66|||constrained Longitudinal Data Analysis|||PAIN: Change from baseline to Week 18 in EORTC QLQ-OES18 Pain subscale was compared between treatment arms based on a cLDA model with EORTC QLQ-OES18 scores as the response variable with covariates for treatment by study visit interaction, and stratification factors including geographic region (Asia versus Rest of the World) and ECOG performance status (0 versus 1).||2.66|-6.93|0.3813
72625826|NCT03189719|144781145|OTHER||Difference in LS Means|-5.11||||0.0816|TWO_SIDED|95.0|-10.86|0.65|||constrained Longitudinal Data Analysis|||REFLUX: Change from baseline to Week 18 in EORTC QLQ-OES18 Reflux subscale was compared between treatment arms based on a cLDA model with EORTC QLQ-OES18 scores as the response variable with covariates for treatment by study visit interaction, and stratification factors including geographic region (Asia versus Rest of the World) and ECOG performance status (0 versus 1).||0.65|-10.86|0.0816
72625827|NCT03189719|144781146|OTHER||Difference in LS Means|-4.49||||0.1632|TWO_SIDED|95.0|-10.81|1.83|||constrained Longitudinal Data Analysis|||DYSPHAGIA: Change from baseline to Week 18 in EORTC QLQ-OES18 Dysphagia subscale was compared between treatment arms based on a cLDA model with EORTC QLQ-OES18 scores as the response variable with covariates for treatment by study visit interaction, and stratification factors including geographic region (Asia versus Rest of the World) and ECOG performance status (0 versus 1).||1.83|-10.81|0.1632
72625828|NCT03189719|144781146|OTHER||Difference in LS Means|-1.71||||0.3259|TWO_SIDED|95.0|-5.12|1.71|||constrained Longitudinal Data Analysis|||PAIN: Change from baseline to Week 18 in EORTC QLQ-OES18 Pain subscale was compared between treatment arms based on a cLDA model with EORTC QLQ-OES18 scores as the response variable with covariates for treatment by study visit interaction, and stratification factors including geographic region (Asia versus Rest of the World) and ECOG performance status (0 versus 1).||1.71|-5.12|0.3259
72572159|NCT02912650|144671814|SUPERIORITY_OR_OTHER||CMH adjusted proportions|41.07|||<|0.001|TWO_SIDED|95.0|28.76|53.38|||Cochran-Mantel-Haenszel|||0.5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||53.38|28.76|<0.001
72572160|NCT02912650|144671814|SUPERIORITY_OR_OTHER||CMH adjusted proportions|4.74||||0.374|TWO_SIDED|95.0|-5.7|15.17|||Cochran-Mantel-Haenszel|||0.5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||15.17|-5.70|0.374
72572161|NCT02912650|144671814|SUPERIORITY_OR_OTHER||CMH adjusted proportions|60.09|||<|0.001|TWO_SIDED|95.0|47.93|72.26|||Cochran-Mantel-Haenszel|||1 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||72.26|47.93|<0.001
72572162|NCT02912650|144671814|SUPERIORITY_OR_OTHER||CMH adjusted proportions|4.3||||0.323|TWO_SIDED|95.0|-4.22|12.81|||Cochran-Mantel-Haenszel|||1 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||12.81|-4.22|0.323
72572163|NCT02912650|144671814|SUPERIORITY_OR_OTHER||CMH adjusted proportions|9.86||||0.032|TWO_SIDED|95.0|0.86|18.86|||Cochran-Mantel-Haenszel|||1 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||18.86|0.86|0.032
72572164|NCT02912650|144671814|SUPERIORITY_OR_OTHER||CMH adjusted proportions|55.66|||<|0.001|TWO_SIDED|95.0|43.11|68.2|||Cochran-Mantel-Haenszel|||1 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||68.20|43.11|<0.001
72572165|NCT02912650|144671814|SUPERIORITY_OR_OTHER||CMH adjusted proportions|50.38|||<|0.001|TWO_SIDED|95.0|37.71|63.05|||Cochran-Mantel-Haenszel|||1 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||63.05|37.71|<0.001
72572166|NCT02912650|144671814|SUPERIORITY_OR_OTHER||CMH adjusted proportions|5.61||||0.232|TWO_SIDED|95.0|-3.58|14.8|||Cochran-Mantel-Haenszel|||1 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||14.80|-3.58|0.232
72572167|NCT02912650|144671814|SUPERIORITY_OR_OTHER||CMH adjusted proportions|59.92|||<|0.001|TWO_SIDED|95.0|47.39|72.46|||Cochran-Mantel-Haenszel|||1.5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||72.46|47.39|<0.001
72625829|NCT03189719|144781146|OTHER||Difference in LS Means|-1.5||||0.4598|TWO_SIDED|95.0|-5.47|2.48|||constrained Longitudinal Data Analysis|||REFLUX: Change from baseline to Week 18 in EORTC QLQ-OES18 Reflux subscale was compared between treatment arms based on a cLDA model with EORTC QLQ-OES18 scores as the response variable with covariates for treatment by study visit interaction, and stratification factors including geographic region (Asia versus Rest of the World) and ECOG performance status (0 versus 1).||2.48|-5.47|0.4598
72625830|NCT03189719|144781147|OTHER||Difference in LS Means|-8.2||||0.0317|TWO_SIDED|95.0|-15.67|-0.73|||constrained Longitudinal Data Analysis|||DYSPHAGIA: Change from baseline to Week 18 in EORTC QLQ-OES18 Dysphagia subscale was compared between treatment arms based on a cLDA model with EORTC QLQ-OES18 scores as the response variable with covariates for treatment by study visit interaction, and stratification factors including geographic region (Asia versus Rest of the World) and tumor histology (Adenocarcinoma versus Squamous Cell Carcinoma).||-0.73|-15.67|0.0317
72625831|NCT03189719|144781147|OTHER||Difference in LS Means|-3.57||||0.0945|TWO_SIDED|95.0|-7.77|0.62|||constrained Longitudinal Data Analysis|||PAIN: Change from baseline to Week 18 in EORTC QLQ-OES18 Pain subscale was compared between treatment arms based on a cLDA model with EORTC QLQ-OES18 scores as the response variable with covariates for treatment by study visit interaction, and stratification factors including geographic region (Asia versus Rest of the World) and tumor histology (Adenocarcinoma versus Squamous Cell Carcinoma).||0.62|-7.77|0.0945
72625832|NCT03189719|144781147|OTHER||Difference in LS Means|-4.76||||0.0555|TWO_SIDED|95.0|-9.64|0.11|||constrained Longitudinal Data Analysis|||REFLUX: Change from baseline to Week 18 in EORTC QLQ-OES18 Reflux subscale was compared between treatment arms based on a cLDA model with EORTC QLQ-OES18 scores as the response variable with covariates for treatment by study visit interaction, and stratification factors including geographic region (Asia versus Rest of the World) and tumor histology (Adenocarcinoma versus Squamous Cell Carcinoma).||0.11|-9.64|0.0555
72625833|NCT02769481|144781165|NON_INFERIORITY|A 95% CI was to be calculated to estimate the range of values in which the treatment difference was likely to lie. If the 95% CI fell below the specified non inferiority margin of 0.35%, the non inferiority of bexagliflozin treatment to glimepiride treatment would be demonstrated and the null hypothesis would be rejected.|Mean Difference (Final Values)|0.05|||||TWO_SIDED|95.0|-0.21|0.11|||||A lower value represents a better treatment effect.|The null hypothesis for the primary endpoint was that the change in HbA1c from baseline to week 60 in the bexagliflozin arm would be greater than change in the glimepiride arm by greater than 0.35%.||0.11|-0.21|
72572168|NCT02912650|144671814|SUPERIORITY_OR_OTHER||CMH adjusted proportions|5.51||||0.179|TWO_SIDED|95.0|-2.52|13.53|||Cochran-Mantel-Haenszel|||1.5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||13.53|-2.52|0.179
72572169|NCT02912650|144671814|SUPERIORITY_OR_OTHER||CMH adjusted proportions|13.37||||0.003|TWO_SIDED|95.0|4.65|22.1|||Cochran-Mantel-Haenszel|||1.5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||22.10|4.65|0.003
72572170|NCT02912650|144671814|SUPERIORITY_OR_OTHER||CMH adjusted proportions|54.32|||<|0.001|TWO_SIDED|95.0|41.36|67.29|||Cochran-Mantel-Haenszel|||1.5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||67.29|41.36|<0.001
72572171|NCT02912650|144671814|SUPERIORITY_OR_OTHER||CMH adjusted proportions|46.74|||<|0.001|TWO_SIDED|95.0|33.5|59.99|||Cochran-Mantel-Haenszel|||1.5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||59.99|33.50|<0.001
72572172|NCT02912650|144671814|SUPERIORITY_OR_OTHER||CMH adjusted proportions|7.91||||0.087|TWO_SIDED|95.0|-1.15|16.97|||Cochran-Mantel-Haenszel|||1.5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||16.97|-1.15|0.087
72572173|NCT02912650|144671814|SUPERIORITY_OR_OTHER||CMH adjusted proportions|60.51|||<|0.001|TWO_SIDED|95.0|47.99|73.03|||Cochran-Mantel-Haenszel|||2 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||73.03|47.99|<0.001
72572174|NCT02912650|144671814|SUPERIORITY_OR_OTHER||CMH adjusted proportions|6.08||||0.135|TWO_SIDED|95.0|-1.89|14.05|||Cochran-Mantel-Haenszel|||2 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||14.05|-1.89|0.135
72572175|NCT02912650|144671814|SUPERIORITY_OR_OTHER||CMH adjusted proportions|13.97||||0.002|TWO_SIDED|95.0|5.3|22.64|||Cochran-Mantel-Haenszel|||2 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||22.64|5.30|0.002
72531486|NCT03451630|144592221|SUPERIORITY|||||||0.009||||||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 3.87 with degrees of freedom (3, 3144).||Test for the change over time when the treatment-by-time interaction effect is not significant.||||0.0090
72531487|NCT03451630|144592221|SUPERIORITY|||||||0.217||||||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 1.53 with degrees of freedom (2, 1227).||Test for the change by treatment when the treatment-by-time interaction effect is not significant.||||0.2170
72531488|NCT03451630|144592221|SUPERIORITY||Mean Difference (Final Values)|0.11|STANDARD_ERROR_OF_MEAN|0.09||0.191|TWO_SIDED|95.0|-0.06|0.28||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 1.71 with degrees of freedom (1, 3138).||Test for Group difference in the change from baseline to 12 months using the linear contrasts.||0.28|-0.06|0.1910
72531489|NCT03451630|144592221|SUPERIORITY||Mean Difference (Final Values)|0.19|STANDARD_ERROR_OF_MEAN|0.08||0.0229|TWO_SIDED|95.0|0.03|0.35||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 5.18 with degrees of freedom (1, 3138).||Test for Group difference in the change from baseline to 12 months using the linear contrasts.||0.35|0.03|0.0229
72531490|NCT03451630|144592221|SUPERIORITY||Mean Difference (Final Values)|-0.08|STANDARD_ERROR_OF_MEAN|0.07||0.2547|TWO_SIDED|95.0|-0.21|0.06||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 1.30 with degrees of freedom (1, 3138).||Test for Group difference in the change from baseline to 12 months using the linear contrasts.||0.06|-0.21|0.2547
72531491|NCT03451630|144592222|SUPERIORITY|||||||0.0413||||||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 2.49 with degrees of freedom (4, 3164).||Overall test for the treatment-by-time interaction||||0.0413
72531492|NCT03451630|144592222|SUPERIORITY||Mean Difference (Final Values)|-0.12|STANDARD_ERROR_OF_MEAN|0.08||0.1433|TWO_SIDED|95.0|-0.28|0.04||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 2.14 with degrees of freedom (1, 3164).||Test for Group difference in the change from baseline to 12-Months using the linear contrasts.||0.04|-0.28|0.1433
72531493|NCT03451630|144592222|SUPERIORITY||Mean Difference (Final Values)|0.07|STANDARD_ERROR_OF_MEAN|0.08||0.4272|TWO_SIDED|95.0|-0.1|0.23||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 0.63 with degrees of freedom (1, 3164).||Test for Group difference in the change from baseline to 12-Months using the linear contrasts.||0.23|-0.10|0.4272
72531494|NCT03451630|144592222|SUPERIORITY||Mean Difference (Final Values)|-0.19|STANDARD_ERROR_OF_MEAN|0.06||0.0037|TWO_SIDED|95.0|-0.31|-0.06||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 8.45 with degrees of freedom (1, 3164).||Test for Group difference in the change from baseline to 12-Months using the linear contrasts.||-0.06|-0.31|0.0037
72531495|NCT03451630|144592223|SUPERIORITY|||||||0.8231||||||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 0.38 with degrees of freedom (4, 3164).||Overall test for the treatment-by-time interaction||||0.8231
72531496|NCT03451630|144592223|SUPERIORITY||||||<|0.0001||||||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 330.05 with degrees of freedom (2, 1948).||Test for the change over time when the treatment-by-time interaction effect is not significant.||||<0.0001
72531497|NCT03451630|144592223|SUPERIORITY|||||||0.6061||||||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 0.50 with degrees of freedom (2 , 1948).||Test for the change by treatment when the treatment-by-time interaction effect is not significant.||||0.6061
72531498|NCT03451630|144592223|SUPERIORITY||Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.05||0.7459|TWO_SIDED|95.0|-0.15|0.11||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 0.11 with degrees of freedom (1, 3164).||Test for Group difference in the change from baseline to 12-Months using the linear contrasts.||0.11|-0.15|0.7459
72572176|NCT02912650|144671814|SUPERIORITY_OR_OTHER||CMH adjusted proportions|54.32|||<|0.001|TWO_SIDED|95.0|41.36|67.29|||Cochran-Mantel-Haenszel|||2 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||67.29|41.36|<0.001
72531499|NCT03451630|144592223|SUPERIORITY||Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.05||0.3169|TWO_SIDED|95.0|-0.18|0.08||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 1.00 with degrees of freedom (1, 3164).||Test for Group difference in the change from baseline to 12-Months using the linear contrasts.||0.08|-0.18|0.3169
72531500|NCT03451630|144592223|SUPERIORITY||Mean Difference (Final Values)|0.04|STANDARD_ERROR_OF_MEAN|0.04||0.4098|TWO_SIDED|95.0|-0.07|0.14||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 0.68 with degrees of freedom (1, 3164).||Test for Group difference in the change from baseline to 12-Months using the linear contrasts.||0.14|-0.07|0.4098
72531501|NCT03451630|144592224|SUPERIORITY|||||||0.4732||||||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 0.88 with degrees of freedom (4, 1945).||Overall test for the treatment-by-time interaction||||0.4732
72531502|NCT03451630|144592224|SUPERIORITY||||||<|0.0001||||||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 319.14 with degrees of freedom (2, 1948).||Test for the change over time when the treatment-by-time interaction effect is not significant.||||<0.0001
72531503|NCT03451630|144592224|SUPERIORITY|||||||0.9628||||||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 0.04 with degrees of freedom (2, 1948).||Test for the change by treatment when the treatment-by-time interaction effect is not significant.||||0.9628
72531504|NCT03451630|144592224|SUPERIORITY||Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.07||0.8438|TWO_SIDED|95.0|-0.16|0.19||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 0.04 with degrees of freedom (1, 1945).||Test for Group difference in the change from baseline to 12-Months using the linear contrasts.||0.19|-0.16|0.8438
72531505|NCT03451630|144592224|SUPERIORITY||Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.07||0.7425|TWO_SIDED|95.0|-0.19|0.15||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 0.11 with degrees of freedom (1, 1945).||Test for Group difference in the change from baseline to 12-Months using the linear contrasts.||0.15|-0.19|0.7425
72531506|NCT03451630|144592224|SUPERIORITY||Mean Difference (Final Values)|0.04|STANDARD_ERROR_OF_MEAN|0.06||0.5044|TWO_SIDED|95.0|-0.1|0.17||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 0.45 with degrees of freedom (1, 1945).||Test for Group difference in the change from baseline to 12-Months using the linear contrasts.||0.17|-0.10|0.5044
72531507|NCT03451630|144592225|SUPERIORITY|||||||0.9804||||||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 0.11 with degrees of freedom (4, 3164).||Overall test for the treatment-by-time interaction||||0.9804
72531508|NCT03451630|144592225|SUPERIORITY||||||<|0.0001||||||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 21.80 with degrees of freedom (2, 3168).||Test for the change over time when the treatment-by-time interaction effect is not significant.||||<0.0001
72531509|NCT03451630|144592225|SUPERIORITY|||||||0.9764||||||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 0.02 with degrees of freedom (2, 1211).||Test for the change by treatment when the treatment-by-time interaction effect is not significant.||||0.9764
72531510|NCT03451630|144592225|SUPERIORITY||Odds Ratio (OR)|1.01||||0.9757|TWO_SIDED|95.0|0.63|1.6||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|T-test statistics 0.03.||Odds ratio of Treatment at 12-Months||1.60|0.63|0.9757
72531511|NCT03451630|144592225|SUPERIORITY||Odds Ratio (OR)|1.06||||0.7958|TWO_SIDED|95.0|0.67|1.68||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|T-test statistics 0.26.||Odds ratio of Treatment at 12-Months||1.68|0.67|0.7958
72531512|NCT03451630|144592225|SUPERIORITY||Odds Ratio (OR)|0.95||||0.7646|TWO_SIDED|95.0|0.67|1.34||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|T-statistics -0.30||Odds ratio of Treatment at 12-Months||1.34|0.67|0.7646
72572177|NCT02912650|144671814|SUPERIORITY_OR_OTHER||CMH adjusted proportions|46.74|||<|0.001|TWO_SIDED|95.0|33.5|59.99|||Cochran-Mantel-Haenszel|||2 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||59.99|33.50|<0.001
72531513|NCT03451630|144592226|SUPERIORITY|||||||0.9622||||||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 0.15 with degrees of freedom (4, 3164).||Overall test for the treatment-by-time interaction||||0.9622
72531514|NCT03451630|144592226|SUPERIORITY|||||||0.0377||||||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 3.28 with degrees of freedom (2, 3168).||Test for the change over time when the treatment-by-time interaction effect is not significant.||||0.0377
72531515|NCT03451630|144592226|SUPERIORITY|||||||0.83||||||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistic 0.19 with degrees of freedom (2, 1903).||Test for the change by treatment when the treatment-by-time interaction effect is not significant.||||0.8300
72531516|NCT03451630|144592226|SUPERIORITY||Odds Ratio (OR)|0.87||||0.7507|TWO_SIDED|95.0|0.38|2.0||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|T-statistics -0.32||Odds ratio of Treatment at 12-Months||2.00|0.38|0.7507
72531517|NCT03451630|144592226|SUPERIORITY||Odds Ratio (OR)|0.94||||0.8844|TWO_SIDED|95.0|0.42|2.13||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|T-statistics -0.15||Odds ratio of Treatment at 12-Months||2.13|0.42|0.8844
72531518|NCT03451630|144592226|SUPERIORITY||Odds Ratio (OR)|0.93||||0.8227|TWO_SIDED|95.0|0.49|1.77||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|T-statistics -0.22||Odds ratio of Treatment at 12-Months||1.77|0.49|0.8227
72531519|NCT03451630|144592227|OTHER|||||||1|||||||Fisher Exact|Fisher's exact test for the null hypothesis of no association between each event and treatment group.||Frequency and test of the marginal association between event rate and treatment for eligible participants' data at 12 months for MMA-1a||||1.00
72531520|NCT03451630|144592227|OTHER|||||||0.242|||||||Fisher Exact|Fisher's exact test for the null hypothesis of no association between each event and treatment group.||Frequency and test of the marginal association between event rate and treatment for eligible participants' data at 12 months for MMA-1b||||0.242
72531521|NCT03451630|144592228|OTHER|||||||0.1112|||||||Fisher Exact|Fisher's exact test for the null hypothesis of no association between each event and treatment group.||Test of the marginal association between event rate and treatment for eligible participants' data at 12 months for PCE-1||||0.1112
72531522|NCT03451630|144592228|OTHER|||||||0.4754|||||||Fisher Exact|Fisher's exact test for the null hypothesis of no association between each event and treatment group.||Test of the marginal association between event rate and treatment for eligible participants' data at 12 months for PCE-2||||0.4754
72531523|NCT03451630|144592229|SUPERIORITY||Odds Ratio (OR)|0.74||||0.9079|TWO_SIDED|95.0|0.13|4.28||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Regression, Logistic|Chi-squared statistics 0.19 with degrees of freedom (2).||Test for the treatment effect (without weight) using a Firth's penalized logistic regression model for rare events.||4.28|0.13|0.9079
72531524|NCT03451630|144592229|SUPERIORITY||Odds Ratio (OR)|0.68||||0.9079|TWO_SIDED|95.0|0.13|3.72||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Regression, Logistic|Chi-squared statistics 0.19 with degrees of freedom (2).||Test for the treatment effect (without weight) using a Firth's penalized logistic regression model for rare events.||3.72|0.13|0.9079
72572178|NCT02912650|144671814|SUPERIORITY_OR_OTHER||CMH adjusted proportions|7.91||||0.087|TWO_SIDED|95.0|-1.15|16.97|||Cochran-Mantel-Haenszel|||2 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||16.97|-1.15|0.087
72572179|NCT02912650|144671814|SUPERIORITY_OR_OTHER||CMH adjusted proportions|58.12|||<|0.001|TWO_SIDED|95.0|45.24|71.0|||Cochran-Mantel-Haenszel|||3 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||71.00|45.24|<0.001
72572180|NCT02912650|144671814|SUPERIORITY_OR_OTHER||CMH adjusted proportions|7.23||||0.071|TWO_SIDED|95.0|-0.63|15.1|||Cochran-Mantel-Haenszel|||3 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||15.10|-0.63|0.071
72572181|NCT02912650|144671814|SUPERIORITY_OR_OTHER||CMH adjusted proportions|15.12|||<|0.001|TWO_SIDED|95.0|6.55|23.69|||Cochran-Mantel-Haenszel|||3 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||23.69|6.55|<0.001
72572182|NCT02912650|144671814|SUPERIORITY_OR_OTHER||CMH adjusted proportions|50.74|||<|0.001|TWO_SIDED|95.0|37.39|64.09|||Cochran-Mantel-Haenszel|||3 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||64.09|37.39|<0.001
72572183|NCT02912650|144671814|SUPERIORITY_OR_OTHER||CMH adjusted proportions|43.16|||<|0.001|TWO_SIDED|95.0|29.56|56.75|||Cochran-Mantel-Haenszel|||3 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||56.75|29.56|<0.001
72531525|NCT03451630|144592229|SUPERIORITY||Odds Ratio (OR)|1.08||||0.9079|TWO_SIDED|95.0|0.34|3.45||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Regression, Logistic|Chi-squared statistics 0.19 with degrees of freedom (2).||Test for the treatment effect (without weight) using a Firth's penalized logistic regression model for rare events.||3.45|0.34|0.9079
72531526|NCT03451630|144592230|SUPERIORITY|||||||0.9912||||||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 0.07 with degrees of freedom (4, 335).||Test for the treatment-by-time interaction (without weight) for SPC-1.||||0.9912
72531527|NCT03451630|144592230|SUPERIORITY|||||||0.876||||||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 0.13 with degrees of freedom (2, 339).||Test for change over time for SPC-1||||0.8760
72531528|NCT03451630|144592230|SUPERIORITY|||||||0.678||||||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 0.39 with degrees of freedom (2, 276).||Test for change in treatment effect for SPC-1||||0.6780
72531529|NCT03451630|144592230|SUPERIORITY|||||||0.1761||||||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 1.59 with degrees of freedom (4, 284).||Test for the treatment-by-time interaction (without weight) for SPC-2||||0.1761
72531530|NCT03451630|144592230|SUPERIORITY|||||||0.3239||||||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 1.13 with degrees of freedom (2, 288).||Test for change over time for SPC-2||||0.3239
72531531|NCT03451630|144592230|SUPERIORITY|||||||0.7415||||||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 0.30 with degrees of freedom (2, 139).||Test for change in treatment effect for SPC-2||||0.7415
72531532|NCT03451630|144592231|SUPERIORITY|||||||0.9786||||||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 0.11 with degrees of freedom (4, 608).||Test for the treatment-by-time interaction (without weight) for SPD-1.||||0.9786
72531533|NCT03451630|144592231|SUPERIORITY|||||||0.4703||||||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 0.76 with degrees of freedom (2, 612).||Test for change over time for SPD-1||||0.4703
72531534|NCT03451630|144592231|SUPERIORITY|||||||0.877||||||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 0.13 with degrees of freedom (2, 332).||Test for change in treatment effect for SPD-1||||0.8770
72531535|NCT03451630|144592231|SUPERIORITY|||||||0.6198||||||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 0.66 with degrees of freedom (4, 469).||Test for the treatment-by-time interaction (without weight) for SPD-2||||0.6198
72531536|NCT03451630|144592231|SUPERIORITY|||||||0.6211||||||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 0.48 with degrees of freedom (2, 473).||Test for change over time for SPD-2||||0.6211
72531537|NCT03451630|144592231|SUPERIORITY|||||||0.1471||||||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 1.93 with degrees of freedom (2, 219).||Test for change in treatment effect for SPD-2.||||0.1471
72531538|NCT03451630|144592232|SUPERIORITY|||||||0.8247||||||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 0.38 with degrees of freedom (4, 280).||Test for the treatment-by-time interaction (without weight) for AMM-1||||0.8247
72531539|NCT03451630|144592232|SUPERIORITY|||||||0.6651||||||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 0.41 with degrees of freedom (2, 284).||Test for change over time for AMM-1||||0.6651
72531540|NCT03451630|144592232|SUPERIORITY|||||||0.3441||||||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 1.07 with degrees of freedom (2, 218).||Test for change in treatment effect for AMM-1||||0.3441
72572184|NCT02912650|144671814|SUPERIORITY_OR_OTHER||CMH adjusted proportions|7.91||||0.087|TWO_SIDED|95.0|-1.15|16.97|||Cochran-Mantel-Haenszel|||3 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||16.97|-1.15|0.087
72531541|NCT03451630|144592232|SUPERIORITY|||||||0.0847||||||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 2.07 with degrees of freedom (4, 280).||Test for the treatment-by-time interaction (without weight) for AMM-2||||0.0847
72531542|NCT03451630|144592232|SUPERIORITY|||||||0.9695||||||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 0.03 with degrees of freedom (2, 284).||Test for change over time for AMM-2||||0.9695
72531543|NCT03451630|144592232|SUPERIORITY|||||||0.9396||||||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 0.06 with degrees of freedom (2, 200).||Test for change in treatment effect for AMM-2||||0.9396
72531544|NCT03503617|144592233|SUPERIORITY|||||||0.03|||||||t-test, 2 sided|||||||0.03
72531545|NCT02452892|144592241|SUPERIORITY|To control for multiple comparisons in the primary endpoint analysis, a hierarchical approach was taken. First LFMS 60min. was compared to LFMS sham. If p\<0.05 for this comparison, then LFMS 20min. was formally compared to LFMS sham for statistical significance.||||||0.307||||||"P-value displayed for 60min.~Mixed Model Repeated Measures (MMRM) model."|Mixed Models Analysis|Week 1 baseline HAM-D6 total score, treatment,visit treatment\*visit age, \& gender included in model. Visit was the repeated measure within subjects.||Comparisons of 60 min LFMS vs. sham, LSMean diff with 95% Confidence Interval (CI) reported. Hypothesis 1: no difference between 60 min. LFMS and sham therapy in mean change from baseline (Day 1) to end of Tx Day 4 in HAM-D6 total score. If hypothesis is rejected at significance level of 0.05, then second hypothesis will be tested. Hypothesis 2:no difference between 20 min. LFMS \& sham therapy in mean change from baseline (Day 1) to the end of Tx. Day 4 in HAM-D6 total score.||||0.307
72572185|NCT02912650|144671814|SUPERIORITY_OR_OTHER||CMH adjusted proportions|58.12|||<|0.001|TWO_SIDED|95.0|45.24|71.0|||Cochran-Mantel-Haenszel|||4 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||71.00|45.24|<0.001
72531546|NCT02452892|144592241|SUPERIORITY|To control for multiple comparisons in the primary endpoint analysis, a hierarchical approach was taken. First LFMS 60min. was compared to LFMS sham. If p\<0.05 for this comparison, then LFMS 20min. was formally compared to LFMS sham for statistical significance.||||||0.859||||||P-value displayed for 20min. Mixed Model Repeated Measures (MMRM) model.|Mixed Models Analysis|Week 1 baseline HAM-D6 total score, treatment,visit treatment\*visit age, \& gender included in model. Visit was the repeated measure within subjects.||Comparisons of 20 min LFMS vs. sham, LSMean diff with 95% Confidence Interval (CI) reported. Hypothesis 1: no difference between 60 min. LFMS and sham therapy in mean change from baseline (Day 1) to end of Tx Day 4 in HAM-D6 total score. If hypothesis is rejected at significance level of 0.05, then second hypothesis will be tested. Hypothesis 2:no difference between 20 min. LFMS \& sham therapy in mean change from baseline (Day 1) to the end of Tx. Day 4 in HAM-D6 total score.||||0.859
72531547|NCT02452892|144592242|SUPERIORITY|||||||0.966||||||P-value is not adjusted for multiple comparisons. P-value was estimated from Mixed Model Repeated Measures (MMRM) model.|Mixed Models Analysis|Week 2 baseline HAM-D6 total score, treatment, visit, treatment\*visit, age, \& gender included in model. Visit was the repeated measure within subject.||||||0.966
72531548|NCT02452892|144592243|SUPERIORITY|The persistence rate calculated based on Week 1 treatment group: 20 minutes LFMS, 60 minutes LFMS and sham therapy.||||||0.294||||||For 60 min LFMS, P-value not adjusted for multiple comparisons. P-value estimated using LR model including Wk2 baseline HAM-D6 total score, treatment, age \& gender as covariates.|Regression, Logistic|Non-responder imputation (NRI) for missing data, where missing post-baseline results were considered non-response||||||0.294
72531549|NCT02452892|144592243|SUPERIORITY|The persistence rate calculated based on Week 1 treatment group: 20 minutes LFMS, 60 minutes LFMS and sham therapy.||||||0.232||||||For 20min. LFMS, P-value not adjusted for multiple comparisons. P-value estimated using Logistic Regression model including Wk2 baseline HAM-D6 total score, treatment, age \& gender as covariates.|Regression, Logistic|Non-responder imputation (NRI) for missing data, where missing post-baseline results were considered non-response||||||0.232
72531550|NCT02452892|144592244|SUPERIORITY|||||||0.0932||||||P-value is not adjusted for multiple comparisons.|ANCOVA|P-value was estimated using ANCOVA model with treatment, age, \& gender as factors and baseline negative MADRS score as a covariate.||Estimates for LS Means, confidence intervals, difference in LS means and p-value are from an ANCOVA model with treatment, age, sex as factors and baseline negative MADRS score as a covariate.||||0.0932
72531551|NCT02452892|144592244|SUPERIORITY|||||||0.7509||||||The p-value is not adjusted for multiple comparisons.|ANCOVA|P-value was estimated using ANCOVA model with treatment, age, \& gender as factors and baseline negative MADRS score as a covariate.||Estimates for LS Means, confidence intervals, difference in LS means and p-value are from an ANCOVA model with treatment, age, sex as factors and baseline negative MADRS score as a covariate.||||0.7509
72531552|NCT02452892|144592245|SUPERIORITY|Positive score is the sum of 10 items: 1,3,5,9,10,12,14,16,17,19.||||||0.2672||||||P-value not adjusted for multiple comparisons.|ANCOVA|P-value estimated using ANCOVA model with treatment,age,\& gender as factors \& baseline positive PANAS score as a covariate.||||||0.2672
72572186|NCT02912650|144671814|SUPERIORITY_OR_OTHER||CMH adjusted proportions|7.23||||0.071|TWO_SIDED|95.0|-0.63|15.1|||Cochran-Mantel-Haenszel|||4 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||15.10|-0.63|0.071
72572187|NCT02912650|144671814|SUPERIORITY_OR_OTHER||CMH adjusted proportions|15.12|||<|0.001|TWO_SIDED|95.0|6.55|23.69|||Cochran-Mantel-Haenszel|||4 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||23.69|6.55|<0.001
72572188|NCT02912650|144671814|SUPERIORITY_OR_OTHER||CMH adjusted proportions|50.74|||<|0.001|TWO_SIDED|95.0|37.39|64.09|||Cochran-Mantel-Haenszel|||4 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||64.09|37.39|<0.001
72572189|NCT02912650|144671814|SUPERIORITY_OR_OTHER||CMH adjusted proportions|43.16|||<|0.001|TWO_SIDED|95.0|29.56|56.75|||Cochran-Mantel-Haenszel|||4 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||56.75|29.56|<0.001
72572190|NCT02912650|144671814|SUPERIORITY_OR_OTHER||CMH adjusted proportions|7.91||||0.087|TWO_SIDED|95.0|-1.15|16.97|||Cochran-Mantel-Haenszel|||4 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||16.97|-1.15|0.087
72572191|NCT02912650|144671814|SUPERIORITY_OR_OTHER||CMH adjusted proportions|58.12|||<|0.001|TWO_SIDED|95.0|45.24|71.0|||Cochran-Mantel-Haenszel|||5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||71.00|45.24|<0.001
72572192|NCT02912650|144671814|SUPERIORITY_OR_OTHER||CMH adjusted proportions|7.23||||0.071|TWO_SIDED|95.0|-0.63|15.1|||Cochran-Mantel-Haenszel|||5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||15.10|-0.63|0.071
72625834|NCT02769481|144781166|SUPERIORITY||Difference of LS Means|-4.31|||<|0.0001|TWO_SIDED|95.0|-5.1|-3.52||P-value is based on one sided statistical tests using a 0.025 level of significance.|Mixed-effects repeated measures|Region, background treatment, baseline HbA1c, baseline eGFR, treatment, visit, treatment-by-visit and baseline weight as a fixed effect covariate.||||-3.52|-5.10|< 0.0001
72625835|NCT02769481|144781167|SUPERIORITY||Difference of LS Means|-6.53||||0.0008|TWO_SIDED|95.0|-10.56|-2.51||P-value is based on one sided statistical tests using a 0.025 level of significance.|Mixed-effects repeated measures|Region, background treatment, baseline HbA1c, baseline eGFR, treatment, visit, treatment-by-visit and baseline weight as a fixed effect covariate.||||-2.51|-10.56|0.0008
72531553|NCT02452892|144592245|SUPERIORITY|Positive score is the sum of 10 items: 1,3,5,9,10,12,14,16,17,19.||||||0.166||||||P-value not adjusted for multiple comparisons.|ANCOVA|P-value estimated using ANCOVA model with treatment,age,\& gender as factors \& baseline positive PANAS score as a covariate.||||||0.1660
72625836|NCT02769481|144781168|SUPERIORITY||Odds Ratio (OR)|0.12|||<|0.0001|TWO_SIDED|95.0|0.05|0.28||P-value is based on one sided statistical tests using a 0.025 level of significance.|Regression, Logistic|Region, baseline HbA1c, background treatment, eGFR at baseline, treatment as a fixed effect covariate.|Odds ratio is calculated as the odds ratio of bexagliflozin over glimepiride.|||0.28|0.05|< 0.0001
72625837|NCT02769481|144781169|SUPERIORITY|Superiority of bexagliflozin over glimepiride in HbA1c reduction from baseline to week 60 will be declared if the upper bound of 95% confidence interval is less than 0|Difference of LS Means|-0.05|||||TWO_SIDED|95.0|-0.21|0.11||||||||0.11|-0.21|
72408000|NCT03238911|144324422|SUPERIORITY||Risk Difference (RD)|-39.2|||<|0.0001|TWO_SIDED|95.0|-52.2|-23.3|||Cochran-Mantel-Haenszel|||Iron isomaltoside/ferric derisomaltose will be compared to ferric carboxymaltose by estimation of the risk difference and the associated 95 % CI, adjusting for strata (type of underlying disease (women with IDA due to gynaecological blood losses; yes/no) and screening s-phosphate level (\< or ≥ 3.5 mg/dL)) using the Cochran-Mantel-Haenszel method.||-23.3|-52.2|<0.0001
72531554|NCT02452892|144592246|SUPERIORITY|Negative score is sum of 10 items: 2,4,6,7,8,11,13,15,18,20.||||||0.0307||||||P-value not adjusted for multiple comparisons. All missing values including the 72 data points in Item#2 were considered as random missing data.|ANCOVA|P-value estimated using ANCOVA model with treatment, age, \& gender as factors \& baseline negative PANAS score as a covariate.||"Due to item #2 error, analyses were done in the following manner to check robustness:~* All missing values including these 72 data points in item #2 were considered as random missing data (values posted in outcome measures).~* The 72 data points were removed \& the negative score for affected subjects \& visits were not calculated.~* The 72 data points were imputed using worst value imputation algorithm (using score =5 as extremely) while other random missing values imputed by average."||||0.0307
72572193|NCT02912650|144671814|SUPERIORITY_OR_OTHER||CMH adjusted proportions|15.12|||<|0.001|TWO_SIDED|95.0|6.55|23.69|||Cochran-Mantel-Haenszel|||5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||23.69|6.55|<0.001
72572194|NCT02912650|144671814|SUPERIORITY_OR_OTHER||CMH adjusted proportions|50.74|||<|0.001|TWO_SIDED|95.0|37.39|64.09|||Cochran-Mantel-Haenszel|||5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||64.09|37.39|<0.001
72572195|NCT02912650|144671814|SUPERIORITY_OR_OTHER||CMH adjusted proportions|43.16|||<|0.001|TWO_SIDED|95.0|29.56|56.75|||Cochran-Mantel-Haenszel|||5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||56.75|29.56|<0.001
72572196|NCT02912650|144671814|SUPERIORITY_OR_OTHER||CMH adjusted proportions|7.91||||0.087|TWO_SIDED|95.0|-1.15|16.97|||Cochran-Mantel-Haenszel|||5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||16.97|-1.15|0.087
72572197|NCT02912650|144671814|SUPERIORITY_OR_OTHER||CMH adjusted proportions|58.12|||<|0.001|TWO_SIDED|95.0|45.24|71.0|||Cochran-Mantel-Haenszel|||6 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||71.00|45.24|<0.001
72572198|NCT02912650|144671814|SUPERIORITY_OR_OTHER||CMH adjusted proportions|7.23||||0.071|TWO_SIDED|95.0|-0.63|15.1|||Cochran-Mantel-Haenszel|||6 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||15.10|-0.63|0.071
72572199|NCT02912650|144671814|SUPERIORITY_OR_OTHER||CMH adjusted proportions|15.12|||<|0.001|TWO_SIDED|95.0|6.55|23.69|||Cochran-Mantel-Haenszel|||6 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||23.69|6.55|<0.001
72625838|NCT04795531|144781194|NON_INFERIORITY|Non-inferiority of insulin icodec was considered confirmed if the upper limit of the two-sided 95% confidence interval (CI) for mean treatment difference (insulin icodec minus insulin degludec) was strictly below 0.3%.|Treatment difference|-0.21|||<|0.0001|TWO_SIDED|95.0|-0.34|-0.08|||ANCOVA|||The response and change from baseline in response after 26 weeks are analysed using an analysis of covariance (ANCOVA) model with treatment, region and sulfonylureas (SU)/glinides use as fixed factors, and baseline response as covariate.||-0.08|-0.34|<0.0001
72625839|NCT04043286|144781204|SUPERIORITY||Mean Difference (Final Values)|0.48|STANDARD_ERROR_OF_MEAN|0.18||0.009|TWO_SIDED|95.0|0.1|0.85|||Wilcoxon (Mann-Whitney)|The Shapiro-Wilk test assessed data normality, and paired t-tests or Wilcoxon tests were applied based on normality results.||The null hypothesis was that there would be no significant difference in peri-implant bone levels between implants with definitive abutments delivered at the time of surgery, and those subjected to multiple abutment disconnections and reconnections. Power analysis was performed and showed that a sample size of 38 implants was needed to achieve 80% power to detect a difference between the null proportion of 0.500 at a significance level of 0.05.||0.85|0.10|0.009
72625840|NCT04043286|144781205|SUPERIORITY||Mean Difference (Final Values)|0.75|STANDARD_ERROR_OF_MEAN|0.23||0.049|TWO_SIDED|95.0|-0.0000168|1.25|||Wilcoxon (Mann-Whitney)|||"The null hypothesis was that there would be no significant difference in peri-implant bone levels between implants with definitive abutments delivered at the time of surgery, and those subjected to multiple abutment disconnections and reconnections. Power analysis was performed and showed that a sample size of 38 implants was needed to achieve 80% power to detect a difference between the null proportion of 0.500 at a significance level of 0.05.~Type of Statistical Test"||1.25|-0.0000168|0.049
72625841|NCT04043286|144781206|SUPERIORITY||Mean Difference (Final Values)|0.38|STANDARD_ERROR_OF_MEAN|0.15||0.053|TWO_SIDED|95.0|-0.0000522|0.75|||Wilcoxon (Mann-Whitney)|||"The null hypothesis was that there would be no significant difference in peri-implant bone levels between implants with definitive abutments delivered at the time of surgery, and those subjected to multiple abutment disconnections and reconnections. Power analysis was performed and showed that a sample size of 38 implants was needed to achieve 80% power to detect a difference between the null proportion of 0.500 at a significance level of 0.05.~Type of Statistical Test"||0.75|-0.0000522|0.053
72625842|NCT01323192|144781208|SUPERIORITY_OR_OTHER||Difference in least square means|-4.5|STANDARD_ERROR_OF_MEAN|1.1|<|0.0001|TWO_SIDED|95.0|-6.7|-2.4|||ANCOVA||LS mean of JNS001 minus LS mean of Placebo|||-2.4|-6.7|<0.0001
72625843|NCT01323192|144781209|SUPERIORITY_OR_OTHER||Difference in least square means|-6.9|STANDARD_ERROR_OF_MEAN|1.83||0.0002|||||||ANCOVA||LS mean of JNS001 minus LS mean of Placebo|||||0.0002
72531555|NCT02452892|144592246|SUPERIORITY|Negative score is sum of 10 items: 2,4,6,7,8,11,13,15,18,20.||||||0.3537||||||"P-value not adjusted for multiple comparisons. All missing values including the 72 data points in Item#2 were considered as random missing data.~."|ANCOVA|P-value estimated using ANCOVA model with treatment, age, \& gender as factors \& baseline negative PANAS score as a covariate.||"Due to item #2 error, analyses were done in the following manner to check robustness:~All missing values including these 72 data points in item #2 were considered as random missing data (values posted in outcome measures).~The 72 data points were removed \& the negative score for affected subjects \& visits were not calculated.~The 72 data points were imputed using worst value imputation algorithm (using score =5 as extremely) while other random missing values imputed by average."||||0.3537
72531556|NCT02452892|144592247|SUPERIORITY|Negative score is sum of 10 items: 2,4,6,7,8,11,13,15,18,20.||||||0.0848||||||P-value not adjusted for multiple comparisons. All missing values including the 72 data points in Item#2 were treated where incorrect Item #2 data was removed.|ANCOVA|P-value estimated using ANCOVA model with treatment, age, \& gender as factors \& baseline negative PANAS score as a covariate.||"Due to item #2 error, analyses were done in the following manner to check robustness:~All missing values including these 72 data points in item #2 were considered as random missing data (values posted in outcome measures).~The 72 data points were removed \& the negative score for affected subjects \& visits were not calculated.~The 72 data points were imputed using worst value imputation algorithm (using score =5 as extremely) while other random missing values imputed by average."||||0.0848
72531557|NCT02452892|144592247|SUPERIORITY|Negative score is sum of 10 items: 2,4,6,7,8,11,13,15,18,20.||||||0.593||||||P-value not adjusted for multiple comparisons. All missing values including the 72 data points in Item#2 were treated where Incorrect Item #2 data was removed.|ANCOVA|P-value estimated using ANCOVA model with treatment, age, \& gender as factors \& baseline negative PANAS score as a covariate.||"Due to item #2 error, analyses were done in the following manner to check robustness:~All missing values including these 72 data points in item #2 were considered as random missing data (values posted in outcome measures).~The 72 data points were removed \& the negative score for affected subjects \& visits were not calculated.~The 72 data points were imputed using worst value imputation algorithm (using score =5 as extremely) while other random missing values imputed by average."||||0.5930
72625844|NCT01323192|144781210|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|||||||<0.0001
72625845|NCT01323192|144781211|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||||||<0.0001
72625846|NCT01323192|144781212|SUPERIORITY_OR_OTHER||Difference in least square means|-6.9|STANDARD_ERROR_OF_MEAN|1.83||0.0003|||||||ANCOVA||LS mean of JNS001 minus LS mean of Placebo|||||0.0003
72625847|NCT01323192|144781213|SUPERIORITY_OR_OTHER|||||||0.4041|||||||ANCOVA|||||||0.4041
72542619|NCT01042977|144615157|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.44|STANDARD_ERROR_OF_MEAN|0.9746||0.0004|TWO_SIDED|95.0|-5.35|-1.53||Significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure|ANCOVA|with treatment group and stratum as effects and baseline value as covariate|with stratum = age-by-insulin use-by-time from most recent qualifying CV event|H0: mean(treat) minus mean(placebo) = 0 versus the alternative HA: mean(treat) minus mean(placebo) =/= 0||-1.53|-5.35|0.0004
72625848|NCT02964377|144781239|EQUIVALENCE|Difference in trough vs. peak values was evaluated using a paired t-test analysis.||||||0.0482|||||||t-test, 2 sided|||||||0.0482
72625849|NCT02964377|144781239|EQUIVALENCE|Difference in trough vs. peak values was evaluated using a paired t-test analysis.||||||0.0075|||||||t-test, 2 sided|||||||0.0075
72625850|NCT02964377|144781239|EQUIVALENCE|Difference in trough vs. peak values was evaluated using a paired t-test analysis.||||||0.0083|||||||t-test, 2 sided|||||||0.0083
72625851|NCT02964377|144781240|EQUIVALENCE|Difference in trough vs. peak values was evaluated using a paired t-test analysis.||||||0.0127|||||||t-test, 2 sided|||||||0.0127
72625852|NCT02964377|144781240|EQUIVALENCE|Difference in trough vs. peak values was evaluated using a paired t-test analysis.||||||0.0202|||||||t-test, 2 sided|||||||0.0202
72625853|NCT02964377|144781240|EQUIVALENCE|Difference in trough vs. peak values was evaluated using a paired t-test analysis.||||||0.0007|||||||t-test, 2 sided|||||||0.0007
72625854|NCT02964377|144781241|OTHER|Mixed Model Repeated Measures (MMRM) regression|||||<|0.0001|||||||Regression, Linear|||Baseline vs. Week 4 (Cohort 1)||||<0.0001
72625855|NCT02964377|144781241|OTHER|Mixed Model Repeated Measures (MMRM) regression|||||<|0.0001|||||||Regression, Linear|||Baseline vs. Week 4 (Cohort 2)||||<0.0001
72625856|NCT02964377|144781241|OTHER|Mixed Model Repeated Measures (MMRM) regression|||||<|0.0001|||||||Regression, Linear|||Baseline vs. Week 4 (Cohort 3)||||<0.0001
72625857|NCT02964377|144781241|OTHER|Mixed Model Repeated Measures (MMRM) regression|||||<|0.0001|||||||Regression, Linear|||Baseline vs. Week 8 (Cohort 1)||||<0.0001
72625858|NCT02964377|144781241|OTHER|Mixed Model Repeated Measures (MMRM) regression|||||<|0.0001|||||||Regression, Linear|||Baseline vs. Week 8 (Cohort 2)||||<0.0001
72625859|NCT02964377|144781241|OTHER|Mixed Model Repeated Measures (MMRM) regression|||||<|0.0001|||||||Regression, Linear|||Baseline vs. Week 8 (Cohort 3)||||<0.0001
72531558|NCT02452892|144592248|SUPERIORITY|Negative score is sum of 10 items: 2,4,6,7,8,11,13,15,18,20.||||||0.0307||||||P-value not adjusted for multiple comparisons. All missing values including the 72 data points in Item#2 were treated where incorrect Item #2 data was imputed using worst possible value.|ANCOVA|P-value estimated using ANCOVA model with treatment, age, \& gender as factors \& baseline negative PANAS score as a covariate.||"Due to item #2 error, analyses were done in the following manner to check robustness:~All missing values including these 72 data points in item #2 were considered as random missing data (values posted in outcome measures).~The 72 data points were removed \& the negative score for affected subjects \& visits were not calculated.~The 72 data points were imputed using worst value imputation algorithm (using score =5 as extremely) while other random missing values imputed by average."||||0.0307
72531559|NCT02452892|144592248|SUPERIORITY|Negative score is sum of 10 items: 2,4,6,7,8,11,13,15,18,20.||||||0.3907||||||P-value not adjusted for multiple comparisons. All missing values including the 72 data points in Item#2 were treated where incorrect Item #2 data was imputed using worst possible value.|ANCOVA|P-value estimated using ANCOVA model with treatment, age, \& gender as factors \& baseline negative PANAS score as a covariate.||"Due to item #2 error, analyses were done in the following manner to check robustness:~All missing values including these 72 data points in item #2 were considered as random missing data (values posted in outcome measures).~The 72 data points were removed \& the negative score for affected subjects \& visits were not calculated.~The 72 data points were imputed using worst value imputation algorithm (using score =5 as extremely) while other random missing values imputed by average."||||0.3907
72531560|NCT02041533|144592304|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.15||||0.2511|TWO_SIDED|95.0|0.91|1.45|||Log Rank|Log-rank test stratified by histology (squamous vs. non-squamous) as entered into the IVRS.|Stratified Cox proportional hazard model. Hazard ratio of nivolumab to investigator's choice chemotherapy.|||1.45|0.91|0.2511
72531561|NCT02041533|144592305|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.17|||||TWO_SIDED|95.0|0.95|1.43|||||Stratified Cox proportional hazard model. Hazard ratio of nivolumab to investigator's choice chemotherapy.|||1.43|0.95|
72531562|NCT02041533|144592306|SUPERIORITY||Hazard Ratio (HR)|0.97|||||TWO_SIDED|95.0|0.79|1.2|||||Stratified Cox proportional hazard model. Hazard ratio of nivolumab to investigator's choice chemotherapy.|||1.20|0.79|
72531563|NCT02041533|144592307|SUPERIORITY||Hazard Ratio (HR)|1.03|||||TWO_SIDED|95.0|0.86|1.24|||||Stratified Cox proportional hazard model. Hazard ratio of nivolumab to investigator's choice chemotherapy.|||1.24|0.86|
72531564|NCT02041533|144592308|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.7|||||TWO_SIDED|95.0|0.46|1.06|||||Stratified by histology (squamous vs.non-squamous) at randomization. Strata adjusted odds ratio (Nivolumab over investigator choice of chemotherapy) using Mantel-Haenszel method.|||1.06|0.46|
72531565|NCT02117024|144592310|SUPERIORITY|||||||0.0011|||||||Log Rank|||||||0.0011
72625860|NCT02964377|144781244|OTHER|Mixed Model Repeated Measures (MMRM) regression||||||0.002|||||||Regression, Linear|||Baseline vs. Week 4||||0.002
72625861|NCT02964377|144781244|OTHER|Mixed Model Repeated Measures (MMRM) regression|||||<|0.001|||||||Regression, Linear|||Baseline vs. Week 4||||<0.001
72625862|NCT02964377|144781244|OTHER|Mixed Model Repeated Measures (MMRM) regression|||||<|0.0001|||||||Regression, Linear|||Baseline vs. Week 4||||<0.0001
72625863|NCT02964377|144781244|OTHER|Mixed Model Repeated Measures (MMRM) regression|||||<|0.0001|||||||Regression, Linear|||Baseline vs. Week 8||||<0.0001
72625864|NCT02964377|144781244|OTHER|Mixed Model Repeated Measures (MMRM) regression|||||<|0.0001|||||||Regression, Linear|||Baseline vs. Week 8||||<0.0001
72625865|NCT02964377|144781244|OTHER|Mixed Model Repeated Measures (MMRM) regression|||||<|0.0001|||||||Regression, Linear|||Baseline vs. Week 8||||<0.0001
72625866|NCT02964377|144781245|OTHER|Mixed Model Repeated Measures (MMRM) regression|||||<|0.0001|||||||Regression, Linear|||Baseline vs. Week 4||||<0.0001
72625867|NCT02964377|144781245|OTHER|Mixed Model Repeated Measures (MMRM) regression|||||<|0.0001|||||||Regression, Linear|||Baseline vs. Week 4||||<0.0001
72625868|NCT02964377|144781245|OTHER|Mixed Model Repeated Measures (MMRM) regression|||||<|0.0001|||||||Regression, Linear|||Baseline vs. Week 4||||<0.0001
72625869|NCT02964377|144781245|OTHER|Mixed Model Repeated Measures (MMRM) regression|||||<|0.0001|||||||Regression, Linear|||Baseline vs. Week 8||||<0.0001
72625870|NCT02964377|144781245|OTHER|Mixed Model Repeated Measures (MMRM) regression|||||<|0.0001|||||||Regression, Linear|||Baseline vs. Week 8||||<0.0001
72625871|NCT02964377|144781245|OTHER|Mixed Model Repeated Measures (MMRM) regression|||||<|0.0001|||||||Regression, Linear|||Baseline vs. Week 8||||<0.0001
72625872|NCT02964377|144781246|OTHER|Mixed Model Repeated Measures (MMRM) regression|||||<|0.0001|||||||Regression, Linear|||Baseline vs. Week 4||||<0.0001
72625873|NCT02964377|144781246|OTHER|Mixed Model Repeated Measures (MMRM) regression|||||<|0.0001|||||||Regression, Linear|||Baseline vs. Week 4||||<0.0001
72625874|NCT02964377|144781246|OTHER|Mixed Model Repeated Measures (MMRM) regression|||||<|0.0001|||||||Regression, Linear|||Baseline vs. Week 4||||<0.0001
72625875|NCT02964377|144781246|OTHER|Mixed Model Repeated Measures (MMRM) regression|||||<|0.0001|||||||Regression, Linear|||Baseline vs. Week 8||||<0.0001
72625876|NCT02964377|144781246|OTHER|Mixed Model Repeated Measures (MMRM) regression|||||<|0.0001|||||||Regression, Linear|||Baseline vs. Week 8||||<0.0001
72625877|NCT02964377|144781246|OTHER|Mixed Model Repeated Measures (MMRM) regression|||||<|0.0001|||||||Regression, Linear|||Baseline vs. Week 8||||<0.0001
72531566|NCT02117024|144592310|OTHER||Hazard Ratio (HR)|1.0|||<|0.05|TWO_SIDED||||||Other|||With only 50% of enrollment complete prior to study termination by sponsor, insufficient sample size exists to fully complete efficacy analysis.||||<0.05
72531567|NCT02500706|144592352|NON_INFERIORITY|"Stepwise hierarchical testing procedure was applied for confirmatory endpoints:~Step 1: Primary analysis: HbA1c non-inferiority of mealtime faster aspart versus mealtime NovoRapid®/NovoLog®.~Non-inferiority of mealtime faster aspart was considered confirmed if the upper boundary of the two-sided 95% CI was below or equal to 0.4%"|Treatment difference|-0.02|||<|0.001|TWO_SIDED|95.0|-0.11|0.07||p-value from the 2-sided test for treatment difference evaluated at the 5% level|ANOVA model after multiple imputation|||The endpoint was analysed using an analysis of variance model after multiple imputation assuming treatment according to randomisation. The model includes treatment, region and bolus adjusting method at randomisation as factors, and baseline HbA1c as a covariate.||0.07|-0.11|<0.001
72531568|NCT02500706|144592352|NON_INFERIORITY|"Stepwise hierarchical testing procedure was applied for confirmatory endpoints:~Step 2: HbA1c non-inferiority of postmeal faster aspart versus mealtime NovoRapid®/NovoLog®.~Non-inferiority of postmeal faster aspart was considered confirmed if the upper boundary of the two-sided 95% CI was below or equal to 0.4%"|Treatment difference|0.1|||<|0.001|TWO_SIDED|95.0|0.004|0.19||p-value from the 2-sided test for treatment difference evaluated at the 5% level.|ANOVA model after multiple imputation|||The endpoint was analysed using an analysis of variance model after multiple imputation assuming treatment according to randomisation. The model includes treatment, region and bolus adjusting method at randomisation as factors, and baseline HbA1c as a covariate.||0.19|0.004|<0.001
72531569|NCT02500706|144592352|SUPERIORITY|"Stepwise hierarchical testing procedure was applied for confirmatory endpoints:~Step 4: HbA1c superiority of mealtime faster aspart versus mealtime NovoRapid®/NovoLog®.~Superiority was to be confirmed if the upper boundary of the two-sided 95% CI of the mean treatment difference (mealtime faster aspart minus mealtime NovoRapid®/NovoLog®) was below 0%-points."|Treatment difference|-0.02||||0.633|TWO_SIDED|95.0|-0.11|0.07||p-value from the 2-sided test for treatment difference evaluated at the 5% level|ANOVA model after multiple imputation|||The endpoint was analysed using an analysis of variance model after multiple imputation assuming treatment according to randomisation. The model includes treatment, region and bolus adjusting method at randomisation as factors, and baseline HbA1c as a covariate.||0.07|-0.11|0.633
72531570|NCT02500706|144592353|SUPERIORITY|"Stepwise hierarchical testing procedure was applied for confirmatory endpoints:~Step 3: 1-hour postprandial glucose (PPG) increments superiority of mealtime faster aspart versus mealtime NovoRapid®/NovoLog.~Superiority was confirmed if the upper boundary of the two-sided 95% CI of the mean treatment difference (mealtime faster aspart minus mealtime NovoRapid®/NovoLog®) was below 0."|Treatment difference|-0.9|||<|0.001|TWO_SIDED|95.0|-1.36|-0.45||p-value from the 2-sided test for treatment difference evaluated at the 5% level.|ANOVA|||Change from baseline in postprandial glucose increment (meal test) is analysed using an analysis of variance model. The model includes treatment, region and bolus adjusting method at randomisation as factors, and baseline postprandial glucose increment as a covariate.||-0.45|-1.36|<0.001
72531571|NCT02500706|144592354|SUPERIORITY|"Stepwise hierarchical testing procedure was applied for confirmatory endpoints:~Step 5: 1,5-anhydroglucitol superiority of mealtime faster aspart versus mealtime NovoRapid®/NovoLog®.~Superiority was to be confirmed if the lower boundary of the two-sided 95% CI of the mean treatment difference (mealtime faster aspart minus mealtime NovoRapid®/NovoLog®) was above 0."|Treatment difference|0.02||||0.924|TWO_SIDED|95.0|-0.31|0.34||p-values are from the 2-sided test for treatment difference evaluated at the 5% level.|ANOVA model after multiple imputation|||Change from baseline in 1,5-anhydroglucitol was analysed using an analysis of variance model after multiple imputation assuming treatment according to randomisation. The model includes treatment, region and bolus adjusting method at randomisation as factors, and baseline 1,5-anhydroglucitol as a covariate.||0.34|-0.31|0.924
72542620|NCT02008721|144615216|SUPERIORITY|||||||0.51|||||||Mixed Models Analysis|||"Power calculation: 80% power, 5% P-level, 50% effect size, i.e. an expected mean yearly UMSARS-ME increase of 3,9 under verum treatment compared to 7.8 ± 6.8 (mean ± standard deviation) under Placebo treatment.~We used a linear mixed-effects model to test the primary hypothesis-ie, to compare differences in the change in motor examination scores on UMSARS between baseline and week 52 between the study groups."||||0.51
72542621|NCT02008721|144615217|SUPERIORITY|||||||0.82|||||||Mixed Models Analysis|||"Power calculation: 80% power, 5% P-level, 50% effect size, i.e. an expected mean yearly UMSARS-ME increase of 3,9 under verum treatment compared to 7.8 ± 6.8 (mean ± standard deviation) under Placebo treatment.~We used a linear mixed-effects model to test the primary hypothesis-ie, to compare differences in the change in motor examination scores on UMSARS between baseline and week 52 between the study groups."||||0.82
72542622|NCT02008721|144615218|SUPERIORITY|||||||0.99|||||||Mixed Models Analysis|||"Power calculation: 80% power, 5% P-level, 50% effect size. We used a linear mixed-effects model to test the primary hypothesis-ie, to compare differences in the change in UMSARS total score between baseline and week 52 between the study groups.~We did a post-hoc power calculation based on the mean change in motor examination scores on UMSARS and SDs in the placebo group of the per-protocol study completer set to test the assumptions of our initial power calculation."||||0.99
72542623|NCT02008721|144615219|SUPERIORITY|||||||0.43|||||||Mixed Models Analysis|||"Power calculation: 80% power, 5% P-level, 50% effect size. We used a linear mixed-effects model to test the primary hypothesis-ie, to compare differences in the change in UMSARS total score between baseline and week 52 between the study groups.~We did a post-hoc power calculation based on the mean change in motor examination scores on UMSARS and SDs in the placebo group of the per-protocol study completer set to test the assumptions of our initial power calculation."||||0.43
72542624|NCT00373685|144615232|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0003|TWO_SIDED|||||Life Table Extension of Cochran-Mantel-Haenszel (CMH) Test|Life Table Extension of CMH Test|||||||0.0003
72625878|NCT02964377|144781247|OTHER|Mixed Model Repeated Measures (MMRM) regression||||||0.012|||||||Regression, Linear|||Baseline vs. Week 4||||0.012
72625879|NCT02964377|144781247|OTHER|Mixed Model Repeated Measures (MMRM) regression|||||<|0.0001|||||||Regression, Linear|||Baseline vs. Week 4||||<0.0001
72542625|NCT00373685|144615233|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0035|TWO_SIDED||||||Life Table Extension of CMH Test|||||||0.0035
72542626|NCT00373685|144615234|SUPERIORITY_OR_OTHER_LEGACY|||||||0.614|TWO_SIDED||||||Life Table Extension of CMH Test|||||||0.6140
72542627|NCT00373685|144615236|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED|||||P-value associated with Overall (LOCF)|ANCOVA|||||||<0.0001
72408001|NCT03238911|144324423|SUPERIORITY||Mean Difference (Final Values)|0.48|||<|0.0001|TWO_SIDED|95.0|0.31|0.65|||Mixed model for repeated measures|||"Day 1~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||0.65|0.31|<0.0001
72531572|NCT01497899|144592416|NON_INFERIORITY_OR_EQUIVALENCE|The null hypothesis was that the E/C/F/TAF group was at least 12% lower than the E/C/F/TDF group with respect to the percentage of participants achieving HIV-1 RNA \< 50 copies/mL at Week 24. The alternative hypothesis was that the E/C/F/TAF group was less than 12% lower than the E/C/F/TDF group.|Difference in percentages|-2.9||||0.58|TWO_SIDED|95.0|-13.5|7.7|||Cochran-Mantel-Haenszel|P-value comparing the percentages of virologic success was from the Cochran-Mantel-Haenszel (CMH) test stratified by baseline HIV-1 RNA stratum.|Difference in percentages of virologic success and its 95% confidence interval (CI) were calculated based on baseline HIV-1 RNA stratum-adjusted Mantel-Haenszel (MH) proportion.|||7.7|-13.5|0.58
72531573|NCT05047601|144592420|SUPERIORITY||Risk Ratio (RR)|0.702||||0.1722|TWO_SIDED|95.0|0.422|1.167|||Generalized estimating equation (GEE)|Model included the fixed effects of treatment, geographic regions and presence of risk factors. Compound symmetry variance-covariance structure.||||1.167|0.422|0.1722
72531574|NCT05047601|144592420|SUPERIORITY||Risk Ratio (RR)|0.645||||0.1163|TWO_SIDED|95.0|0.373|1.115|||GEE|Model included the fixed effects of treatment, geographic regions and presence of risk factors. Compound symmetry variance-covariance structure.||||1.115|0.373|0.1163
72531575|NCT05047601|144592422|SUPERIORITY||Risk Ratio (RR)|0.88||||0.6766|TWO_SIDED|95.0|0.484|1.602|||GEE|Model included the fixed effects of treatment, geographic regions. Compound symmetry variance-covariance structure.||||1.602|0.484|0.6766
72531576|NCT05047601|144592422|SUPERIORITY||Risk Ratio (RR)|0.809||||0.507|TWO_SIDED|95.0|0.433|1.512|||GEE|Model included the fixed effects of treatment, geographic regions. Compound symmetry variance-covariance structure.||||1.512|0.433|0.5070
72531577|NCT05047601|144592424|SUPERIORITY||Risk Ratio (RR)|0.672||||0.1869|TWO_SIDED|95.0|0.373|1.213|||GEE|Model included the fixed effects of treatment, geographic regions and presence of risk factors. Compound symmetry variance-covariance structure.||||1.213|0.373|0.1869
72531578|NCT05047601|144592424|SUPERIORITY||Risk Ratio (RR)|0.633||||0.1221|TWO_SIDED|95.0|0.355|1.13|||GEE|Model included the fixed effects of treatment, geographic regions and presence of risk factors. Compound symmetry variance-covariance structure.||||1.130|0.355|0.1221
72531579|NCT05047601|144592425|SUPERIORITY|||||||0.0368|||||||Log Rank|||||||0.0368
72531580|NCT05047601|144592425|SUPERIORITY|||||||0.0186|||||||Log Rank|||||||0.0186
72531581|NCT05047601|144592426|SUPERIORITY||Risk Ratio (RR)|0.75||||0.4126|TWO_SIDED|95.0|0.378|1.491|||GEE|Model included the fixed effects of treatment, geographic regions and presence of risk factors. Compound symmetry variance-covariance structure.||||1.491|0.378|0.4126
72531582|NCT05047601|144592426|SUPERIORITY||Risk Ratio (RR)|1.244||||0.4273|TWO_SIDED|95.0|0.725|2.135|||GEE|Model included the fixed effects of treatment, geographic regions and presence of risk factors. Compound symmetry variance-covariance structure.||||2.135|0.725|0.4273
72531583|NCT05047601|144592427|SUPERIORITY||Risk Ratio (RR)|0.726||||0.1333|TWO_SIDED|95.0|0.478|1.103|||GEE|Model included the fixed effects of treatment, geographic regions and presence of risk factors. Compound symmetry variance-covariance structure.||||1.103|0.478|0.1333
72531584|NCT05047601|144592427|SUPERIORITY||Risk Ratio (RR)|0.953||||0.8088|TWO_SIDED|95.0|0.645|1.408|||GEE|Model included the fixed effects of treatment, geographic regions and presence of risk factors. Compound symmetry variance-covariance structure.||||1.408|0.645|0.8088
72531585|NCT05047601|144592435|SUPERIORITY||LS Mean Ratio|0.969||||0.7991|TWO_SIDED|95.0|0.758|1.238|||Negative binomial regression model|||||1.238|0.758|0.7991
72531586|NCT05047601|144592435|SUPERIORITY||LS Mean Ratio|0.847||||0.1985|TWO_SIDED|95.0|0.657|1.091|||Negative binomial regression model|||||1.091|0.657|0.1985
72625880|NCT02964377|144781247|OTHER|Mixed Model Repeated Measures (MMRM) regression|||||<|0.0001|||||||Regression, Linear|||Baseline vs. Week 4||||<0.0001
72531587|NCT02347124|144592436|SUPERIORITY||Odds Ratio (OR)|1.29||||0.13|TWO_SIDED|95.0|0.93|1.78||Adjusted for baseline sex, age, cigarettes per day, depression history, motivation, self-efficacy, current use of a stop-smoking medication, state quitline, and dental insurance.|Regression, Logistic|||||1.78|0.93|0.13
72531588|NCT02347124|144592437|SUPERIORITY||Odds Ratio (OR)|1.03||||0.9|TWO_SIDED|95.0|0.69|1.53||Adjusted for baseline sex, age, depression history, motivation, self-efficacy, state quitline, and dental insurance.|Regression, Logistic|||||1.53|0.69|0.90
72531589|NCT02347124|144592438|SUPERIORITY||Odds Ratio (OR)|1.22||||0.21|TWO_SIDED|95.0|0.89|1.69||Model is adjusted for sex, age, cigarettes per day at baseline, depression, self-efficacy, motivation, self-reported use of a stop smoking medication at baseline, and stratification variables state quit line and dental insurance.|Regression, Logistic|||||1.69|0.89|0.21
72531590|NCT02347124|144592439|SUPERIORITY||Odds Ratio (OR)|1.42||||0.04|TWO_SIDED|95.0|1.01|2.0||Model is adjusted for sex, age, cigarettes per day at baseline, depression, self-efficacy, motivation, self-reported use of a stop smoking medication at baseline, and stratification variables state quit line and dental insurance.|Regression, Logistic|||||2.00|1.01|0.04
72531591|NCT02347124|144592440|SUPERIORITY||Odds Ratio (OR)|1.37||||0.09|TWO_SIDED|95.0|0.95|1.96||Model is adjusted for sex, age, cigarettes per day at baseline, depression, self-efficacy, motivation, self-reported use of a stop smoking medication at baseline, and stratification variables state quit line and dental insurance.|Regression, Logistic|||||1.96|0.95|0.09
72531592|NCT02347124|144592441|SUPERIORITY||Odds Ratio (OR)|-0.05||||0.85|TWO_SIDED|95.0|-0.57|0.47|||Regression, Linear|Adjusted for sex, age, state quit line, and baseline knowledge score.||||0.47|-0.57|0.85
72531593|NCT02347124|144592442|SUPERIORITY||Odds Ratio (OR)|0.41||||0.14|TWO_SIDED|95.0|-0.14|0.96|||Regression, Linear|Adjusted for sex, age, state quit line, and baseline knowledge score.||||0.96|-0.14|0.14
72531594|NCT02347124|144592443|SUPERIORITY||Odds Ratio (OR)|0.35||||0.002|TWO_SIDED|95.0|0.13|0.56|||Regression, Linear|Adjusted for sex, age, state quit line, and baseline self-efficacy score.||||0.56|0.13|.002
72531595|NCT02347124|144592444|SUPERIORITY||Odds Ratio (OR)|0.0||||0.97|TWO_SIDED|95.0|-0.22|0.23||Adjusted for sex, age, state quit line, and baseline self-efficacy score.|Regression, Linear|||||0.23|-0.22|0.97
72625881|NCT02964377|144781247|OTHER|Mixed Model Repeated Measures (MMRM) regression||||||0.01|||||||Regression, Linear|||Baseline vs. Week 8||||0.01
72531596|NCT02347124|144592445|SUPERIORITY||Odds Ratio (OR)|-0.1||||0.16|TWO_SIDED|95.0|-0.24|0.04|||Regression, Linear|Adjusted for sex, age, state quit line, use of stop-smoking medications, baseline motivation, and baseline cigarettes per day.||||0.04|-0.24|0.16
72531597|NCT02347124|144592446|SUPERIORITY||Odds Ratio (OR)|-0.02||||0.83|TWO_SIDED|95.0|-0.16|0.13|||Regression, Linear|Adjusted for sex, age, state quit line, use of a smoking cessation medication at baseline, baseline motivation score, and baseline cigarettes per day.||||0.13|-0.16|0.83
72531598|NCT02347124|144592447|SUPERIORITY||Odds Ratio (OR)|0.22||||0.02|TWO_SIDED|95.0|0.04|0.41|||Regression, Linear|adjusted for sex, age, state quit line, and baseline motivation score.||||0.41|0.04|0.02
72531599|NCT02347124|144592448|SUPERIORITY||Odds Ratio (OR)|0.02||||0.82|TWO_SIDED|95.0|-0.17|0.21|||Regression, Linear|||||0.21|-0.17|0.82
72531600|NCT02347124|144592449|SUPERIORITY||Odds Ratio (OR)|-0.02||||0.8|TWO_SIDED|95.0|-0.2|0.16|||Regression, Linear|Adjusted for sex, age, state quit line, baseline self-efficacy score, baseline cigarettes per day, and baseline use of stop smoking medications.||||0.16|-0.20|0.80
72531601|NCT02347124|144592450|SUPERIORITY||Odds Ratio (OR)|0.07||||0.45|TWO_SIDED|95.0|-0.11|0.26|||Regression, Linear|Adjusted for sex, age, state quit line, baseline self-efficacy score, baseline cigarettes per day, and baseline use of stop smoking medication.||||0.26|-0.11|0.45
72531602|NCT03137173|144592459|NON_INFERIORITY|Non-inferiority was assessed by the two-sided 95% confidence interval (CI) of the between-group difference (ceftobiprole minus vancomycin+aztreonam) using a 10% non-inferiority margin in the ITT population. Difference was computed using the Cochran-Mantel-Haenszel (CMH) weights method, adjusted for geographical region and actual type of ABSSSI.|Risk Difference (RD)|3.3|||||TWO_SIDED|95.0|-1.2|7.8||||||||7.8|-1.2|
72531603|NCT03137173|144592460|NON_INFERIORITY|Non-inferiority was assessed by the two-sided 95% CI of the between-group difference (ceftobiprole minus vancomycin+aztreonam) using a 10% non-inferiority margin in the ITT population. Difference was computed using the CMH weights method, adjusted for geographical region and actual type of ABSSSI.|Risk Difference (RD)|1.0|||||TWO_SIDED|95.0|-3.5|5.6||||||||5.6|-3.5|
72531604|NCT03137173|144592461|NON_INFERIORITY|Non-inferiority was assessed by the two-sided 95% CI of the between-group difference (ceftobiprole minus vancomycin plus aztreonam) using a 10% non-inferiority margin in the CE populations. Difference was computed using the CMH weights method, adjusted for geographical region and actual type of ABSSSI.|Risk Difference (RD)|2.7|||||TWO_SIDED|95.0|-0.3|5.6||||||||5.6|-0.3|
72531605|NCT01522391|144592482|OTHER||Ratio between geometric means|0.045||||0.012|TWO_SIDED|95.0|0.004|0.491|||Mixed Models Analysis|||||0.491|0.004|0.012
72625882|NCT02964377|144781247|OTHER|Mixed Model Repeated Measures (MMRM) regression|||||<|0.0001|||||||Regression, Linear|||Baseline vs. Week 8||||<0.0001
72531606|NCT01522391|144592483|OTHER||Ratio between geometric means|0.045||||0.012|TWO_SIDED|95.0|0.004|0.491|||Mixed Models Analysis|||||0.491|0.004|0.012
72531607|NCT01522391|144592484|OTHER||Ratio between geometric means|0.242||||0.242|TWO_SIDED|95.0|0.022|2.66|||Mixed Models Analysis|||Day 7||2.66|0.022|0.242
72531608|NCT01522391|144592484|OTHER||Ratio between geometric means|0.428||||0.482|TWO_SIDED|95.0|0.039|4.696|||Mixed Models Analysis|||Day 21||4.696|0.039|0.482
72531609|NCT01522391|144592485|OTHER||Ratio between geometric means|0.242||||0.242|TWO_SIDED|95.0|0.022|2.66|||Mixed Models Analysis|||Day 7||2.660|0.022|0.242
72531610|NCT01522391|144592485|OTHER||Ratio between geometric means|0.428||||0.482|TWO_SIDED|95.0|0.039|4.696|||Mixed Models Analysis|||Day 21||4.696|0.039|0.482
72531611|NCT01522391|144592486|OTHER||Ratio between geometric means|0.288||||0.395|TWO_SIDED|95.0|0.016|5.221|||Mixed Models Analysis|||Day 7||5.221|0.016|0.395
72531612|NCT01522391|144592486|OTHER||Ratio between geometric means|0.067||||0.067|TWO_SIDED|95.0|0.004|1.218|||Mixed Models Analysis|||Day 14||1.218|0.004|0.067
72531613|NCT01522391|144592486|OTHER||Ratio between geometric means|0.484||||0.62|TWO_SIDED|95.0|0.027|8.787|||Mixed Models Analysis|||Day 21||8.787|0.027|0.620
72531614|NCT01522391|144592487|OTHER||Ratio between geometric means|0.287||||0.403|TWO_SIDED|95.0|0.015|5.55|||Mixed Models Analysis|||Day 7||5.550|0.015|0.403
72531615|NCT01522391|144592487|OTHER||Ratio between geometric means|0.032||||0.021|TWO_SIDED|95.0|0.002|0.583|||Mixed Models Analysis|||Day 14||0.583|0.002|0.021
72531616|NCT01522391|144592487|OTHER||Ratio between geometric means|0.271||||0.368|TWO_SIDED|95.0|0.015|4.779|||Mixed Models Analysis|||Day 21||4.779|0.015|0.368
72531617|NCT01522391|144592488|OTHER||Ratio between geometric means|1.045||||0.97|TWO_SIDED|95.0|0.106|10.32|||Mixed Models Analysis|||Day 7||10.32|0.106|0.970
72531618|NCT01522391|144592488|OTHER||Ratio between geometric means|0.045||||0.009|TWO_SIDED|95.0|0.005|0.447|||Mixed Models Analysis|||Day 14||0.447|0.005|0.009
72531619|NCT01522391|144592488|OTHER||Ratio between geometric means|0.36||||0.377|TWO_SIDED|95.0|0.036|3.556|||Mixed Models Analysis|||Day 21||3.556|0.036|0.377
72531620|NCT01522391|144592489|OTHER||Ratio between geometric means|0.961||||0.974|TWO_SIDED|95.0|0.081|11.43|||Mixed Models Analysis|||Day 7||11.43|0.081|0.974
72531621|NCT01522391|144592489|OTHER||Ratio between geometric means|0.046||||0.013|TWO_SIDED|95.0|0.004|0.512|||Mixed Models Analysis|||Day 14||0.512|0.004|0.013
72531622|NCT01522391|144592489|OTHER||Ratio between geometric means|0.447||||0.504|TWO_SIDED|95.0|0.041|4.883|||Mixed Models Analysis|||Day 21||4.883|0.041|0.504
72531623|NCT01522391|144592490|OTHER||Ratio between geometric means|0.242||||0.242|TWO_SIDED|95.0|0.022|2.659|||Mixed Models Analysis|||Day 7||2.659|0.022|0.242
72531624|NCT01522391|144592490|OTHER||Ratio between geometric means|0.045||||0.012|TWO_SIDED|95.0|0.004|0.491|||Mixed Models Analysis|||Day 14||0.491|0.004|0.012
72531625|NCT01522391|144592490|OTHER||Ratio between geometric means|0.428||||0.483|TWO_SIDED|95.0|0.039|4.697|||Mixed Models Analysis|||Day 21||4.697|0.039|0.483
72531626|NCT01522391|144592491|OTHER||Ratio between geometric means|0.202||||0.197|TWO_SIDED|95.0|0.017|2.34|||Mixed Models Analysis|||Day 7||2.340|0.017|0.197
72531627|NCT01522391|144592491|OTHER||Ratio between geometric means|0.021||||0.002|TWO_SIDED|95.0|0.002|0.227|||Mixed Models Analysis|||Day 14||0.227|0.002|0.002
72531628|NCT01522391|144592491|OTHER||Ratio between geometric means|0.257||||0.257|TWO_SIDED|95.0|0.024|2.752|||Mixed Models Analysis|||Day 21||2.752|0.024|0.257
72531629|NCT01522391|144592492|OTHER||Least Square Mean Difference|20.38||||0.346|TWO_SIDED|95.0|-22.42|63.19|||Mixed Models Analysis|||Day 7||63.19|-22.42|0.346
72531630|NCT01522391|144592492|OTHER||Least Square Mean Difference|29.1||||0.18|TWO_SIDED|95.0|-13.71|71.9|||Mixed Models Analysis|||Day 14||71.90|-13.71|0.18
72531631|NCT01522391|144592492|OTHER||Least Square Mean Difference|-11.64||||0.59|TWO_SIDED|95.0|-54.44|31.16|||Mixed Models Analysis|||Day 21||31.16|-54.44|0.590
72531632|NCT01522391|144592493|OTHER||Least Square Mean Difference|5.95||||0.748|TWO_SIDED|95.0|-30.84|42.73|||Mixed Models Analysis|||Day 7||42.73|-30.84|0.748
72531633|NCT01522391|144592493|OTHER||Least Square Mean Difference|14.62||||0.437|TWO_SIDED|95.0|-22.65|51.88|||Mixed Models Analysis|||Day 14||51.88|-22.65|0.437
72531634|NCT01522391|144592493|OTHER||Least Square Mean Difference|-18.66||||0.322|TWO_SIDED|95.0|-55.92|18.61|||Mixed Models Analysis|||Day 21||18.61|-55.92|0.322
72531635|NCT01522391|144592494|OTHER||Least Square Mean Difference|8.04||||0.631|TWO_SIDED|95.0|-25.15|41.24|||Mixed Models Analysis|||Day 7||41.24|-25.15|0.631
72531636|NCT01522391|144592494|OTHER||Least Square Mean Difference|20.44||||0.224|TWO_SIDED|95.0|-12.75|53.63|||Mixed Models Analysis|||Day 14||53.63|-12.75|0.224
72531637|NCT01522391|144592494|OTHER||Least Square Mean Difference|-1.23||||0.941|TWO_SIDED|95.0|-34.42|31.96|||Mixed Models Analysis|||Day 21||31.96|-34.42|0.941
72531638|NCT01522391|144592495|OTHER||Least Square Means Difference|0.97||||0.954|TWO_SIDED|95.0|-32.93|34.87|||Mixed Models Analysis|||Day 7||34.87|-32.93|0.954
72531639|NCT01522391|144592495|OTHER||Least Square Mean Difference|15.72||||0.358|TWO_SIDED|95.0|-18.18|49.62|||Mixed Models Analysis|||Day 14||49.62|-18.18|0.358
72531640|NCT01522391|144592495|OTHER||least Square Mean Difference|-7.94||||0.642|TWO_SIDED|95.0|-41.82|25.94|||Mixed Models Analysis|||Day 21||25.94|-41.82|0.642
72531641|NCT01522391|144592496|OTHER|||||||0.701|||||||Cochran-Mantel-Haenszel|||Day 7||||0.701
72531642|NCT01522391|144592496|OTHER|||||||0.898|||||||Cochran-Mantel-Haenszel|||Day 14||||0.898
72531643|NCT01522391|144592496|OTHER|||||||0.271|||||||Cochran-Mantel-Haenszel|||Day 21||||0.271
72531644|NCT01522391|144592497|OTHER|||||||0.511|||||||Cochran-Mantel-Haenszel|||Day 7||||0.511
72531645|NCT01522391|144592497|OTHER|||||||0.777|||||||Cochran-Mantel-Haenszel|||Day 14||||0.777
72531646|NCT01522391|144592497|OTHER|||||||0.204|||||||Cochran-Mantel-Haenszel|||Day 21||||0.204
72531647|NCT01522391|144592498|OTHER|||||||0.489|||||||Cochran-Mantel-Haenszel|||Day 7||||0.489
72531648|NCT01522391|144592498|OTHER|||||||0.249|||||||Cochran-Mantel-Haenszel|||Day 14||||0.249
72531649|NCT01522391|144592498|OTHER|||||||0.098|||||||Cochran-Mantel-Haenszel|||Day 21||||0.098
72531650|NCT01522391|144592499|OTHER|||||||0.291|||||||Cochran-Mantel-Haenszel|||Day 7||||0.291
72531651|NCT01522391|144592499|OTHER|||||||0.113|||||||Cochran-Mantel-Haenszel|||Day 14||||0.113
72531652|NCT01522391|144592499|OTHER|||||||0.033|||||||Cochran-Mantel-Haenszel|||Day 21||||0.033
72531653|NCT01522391|144592500|OTHER|||||||0.825|||||||Cochran-Mantel-Haenszel|||Day 7||||0.825
72531654|NCT01522391|144592500|OTHER|||||||0.825|||||||Cochran-Mantel-Haenszel|||Day 14||||0.825
72531655|NCT01522391|144592500|OTHER|||||||0.208|||||||Cochran-Mantel-Haenszel|||||||0.208
72531656|NCT01522391|144592501|OTHER|||||||0.825|||||||Cochran-Mantel-Haenszel|||Day 7||||0.825
72531657|NCT01522391|144592501|OTHER|||||||0.82|||||||Cochran-Mantel-Haenszel|||Day 14||||0.820
72531658|NCT01522391|144592501|OTHER|||||||0.086|||||||Cochran-Mantel-Haenszel|||Day 21||||0.086
72531659|NCT01522391|144592502|OTHER|||||||0.378|||||||Cochran-Mantel-Haenszel|||Day 7||||0.378
72531660|NCT01522391|144592502|OTHER|||||||0.975|||||||Cochran-Mantel-Haenszel|||Day 14||||0.975
72531661|NCT01522391|144592502|OTHER|||||||0.962|||||||Cochran-Mantel-Haenszel|||Day 21||||0.962
72531662|NCT01522391|144592503|OTHER|||||||0.375|||||||Cochran-Mantel-Haenszel|||Day 7||||0.375
72531663|NCT01522391|144592503|OTHER|||||||0.946|||||||Cochran-Mantel-Haenszel|||Day 14||||0.946
72531664|NCT01522391|144592503|OTHER|||||||0.495|||||||Cochran-Mantel-Haenszel|||Day 21||||0.495
72531665|NCT01522391|144592506|OTHER|||||||0.477|||||||Wilcoxon (Mann-Whitney)|||Day 7 morning||||0.477
72531666|NCT01522391|144592506|OTHER|||||||0.651|||||||Wilcoxon (Mann-Whitney)|||Day 14 morning||||0.651
72531667|NCT01522391|144592506|OTHER|||||||0.34|||||||Wilcoxon (Mann-Whitney)|||Day 21 morning||||0.340
72531668|NCT01522391|144592507|OTHER|||||||0.3|||||||Wilcoxon (Mann-Whitney)|||Day 7 morning||||0.300
72531669|NCT01522391|144592507|OTHER|||||||0.705|||||||Wilcoxon (Mann-Whitney)|||Day 14||||0.705
72531670|NCT01522391|144592507|OTHER|||||||0.286|||||||Wilcoxon (Mann-Whitney)|||Day 21||||0.286
72531671|NCT02828982|144592520|SUPERIORITY|||||||0.585||||||Statistical significance was set a-priori at p\<0.05|t-test, 2 sided|||The null hypothesis was that there would be no difference in metabolic costs between the two groups||||0.585
72531672|NCT02828982|144592521|SUPERIORITY|||||||0.452||||||Statistical significance was set a-priori at p\<0.05|t-test, 2 sided|||The null hypothesis was that there were no differences in the number of steps taken outside of the home for the two prostheses.||||0.452
72531673|NCT02828982|144592522|OTHER|paired t-test of Physical component scores between the two conditions||||||0.48||||||a prior threshold for significance was 0.05|t-test, 2 sided|||||||0.480
72531674|NCT02828982|144592522|SUPERIORITY|||||||0.408||||||Statistical significance was set a-priori at p\<0.05|t-test, 2 sided|||Mental Component Score||||0.408
72531675|NCT02828982|144592523|SUPERIORITY|||||||0.058||||||Statistical significance was set a-priori at p\<0.05.|t-test, 2 sided|||Ambulation Score||||0.058
72531676|NCT02828982|144592523|OTHER|paired t-test between conditions||||||0.123||||||Statistical significance was set a-priori at p\<0.05.|t-test, 2 sided|||Appearance Score||||.123
72531677|NCT02828982|144592523|OTHER|paired t-test between conditions||||||0.052||||||Statistical significance was set a-priori at p\<0.05.|t-test, 2 sided|||Frustration Score||||.052
72531678|NCT02828982|144592523|OTHER|paired t-test between conditions||||||0.188||||||Statistical significance was set a-priori at p\<0.05.|t-test, 2 sided|||Perceived Response Score||||.188
72531679|NCT02828982|144592523|OTHER|paired t-test between conditions||||||0.336||||||Statistical significance was set a-priori at p\<0.05.|t-test, 2 sided|||Residual Limb Health Score||||.336
72531680|NCT02828982|144592523|OTHER|paired t-test between conditions||||||0.043||||||Statistical significance was set a-priori at p\<0.05.|t-test, 2 sided|||Social Burden Score||||.043
72531681|NCT02828982|144592523|OTHER|paired t-test between conditions||||||0.391||||||Statistical significance was set a-priori at p\<0.05.|t-test, 2 sided|||Sounds Score||||.391
72531682|NCT02828982|144592523|SUPERIORITY|paired t-test between conditions||||||0.799||||||Statistical significance was set a-priori at p\<0.05.|t-test, 2 sided|||Utility Score||||.799
72531683|NCT02828982|144592523|SUPERIORITY|||||||0.173||||||Statistical significance was set a-priori at p\<0.05.|t-test, 2 sided|||Well-Being||||.173
72625883|NCT02964377|144781247|OTHER|Mixed Model Repeated Measures (MMRM) regression|||||<|0.0001|||||||Regression, Linear|||Baseline vs. Week 8||||<0.0001
72531684|NCT02828982|144592524|OTHER|paired t-test between conditions||||||0.655||||||Statistical significance was set a-priori at p\<0.05.|t-test, 2 sided|||Intact Side Biceps Femoris||||0.655
72625884|NCT02964377|144781249|OTHER|Mixed Model Repeated Measures (MMRM) regression||||||0.01|||||||Regression, Linear|||Baseline vs. Week 4||||0.01
72625885|NCT02964377|144781249|OTHER|Mixed Model Repeated Measures (MMRM) regression||||||0.019|||||||Regression, Linear|||Baseline vs. Week 4||||0.019
72625886|NCT02964377|144781249|OTHER|Mixed Model Repeated Measures (MMRM) regression|||||<|0.001|||||||Regression, Linear|||Baseline vs. Week 8||||<0.001
72625887|NCT02964377|144781249|OTHER|Mixed Model Repeated Measures (MMRM) regression||||||0.05|||||||Regression, Linear|||Baseline vs. Week 8||||0.05
72625888|NCT02964377|144781250|OTHER|Mixed Model Repeated Measures (MMRM) regression||||||0.054||||||p-value for difference at Week 4|Regression, Linear|||Baseline vs. Week 8||||0.054
72625889|NCT02964377|144781250|OTHER|Mixed Model Repeated Measures (MMRM) regression||||||0.009|||||||Regression, Linear|||Baseline vs. Week 4||||0.009
72625890|NCT02964377|144781251|OTHER|Mixed Model Repeated Measures (MMRM) regression||||||0.025|||||||Regression, Linear|||Baseline vs. Week 8||||0.025
72625891|NCT02964377|144781251|OTHER|Mixed Model Repeated Measures (MMRM) regression||||||0.026|||||||Regression, Linear|||Baseline vs. Week 4||||0.026
72625892|NCT02964377|144781252|OTHER|Mixed Model Repeated Measures (MMRM) regression||||||0.006|||||||Regression, Linear|||Baseline vs. Week 4||||0.006
72625893|NCT02964377|144781252|OTHER|Mixed Model Repeated Measures (MMRM) regression||||||0.002|||||||Regression, Linear|||Baseline vs. Week 8||||0.002
72408002|NCT03238911|144324423|SUPERIORITY||Mean Difference (Final Values)|1.06|||<|0.0001|TWO_SIDED|95.0|0.85|1.27|||Mixed model for repeated measures|||"Day 7~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||1.27|0.85|<0.0001
72531685|NCT02828982|144592524|OTHER|paired t-test between conditions||||||0.281||||||Statistical significance was set a-priori at p\<0.05.|t-test, 2 sided|||Intact Side Rectus Femoris||||.281
72531686|NCT02828982|144592524|OTHER|paired t-test between conditions||||||0.844||||||Statistical significance was set a-priori at p\<0.05.|t-test, 2 sided|||Intact Side Soleus||||.844
72531687|NCT02828982|144592524|OTHER|paired t-test between conditions||||||0.11||||||Statistical significance was set a-priori at p\<0.05.|t-test, 2 sided|||Intact Side Tibialis Anterior||||.110
72531688|NCT02828982|144592524|OTHER|paired t-test between conditions||||||0.394||||||Statistical significance was set a-priori at p\<0.05.|t-test, 2 sided|||Residual Side Biceps Femoris||||.394
72531689|NCT02828982|144592524|SUPERIORITY|||||||0.141||||||Statistical significance was set a-priori at p\<0.05.|t-test, 2 sided|||Residual Side Rectus Femoris||||.141
72531690|NCT02828982|144592525|SUPERIORITY|||||||0.212||||||Statistical significance was set a-priori at p\<0.05|t-test, 2 sided|||||||0.212
72531691|NCT00195702|144592545|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||The 3 primary efficacy variables were considered in a hierarchical order, with the ACR20 response tested first. The ACR20 response rate at Week 24 was initially assessed using Pearson's chi-squared test at a significance level of 0.05. If significant, pairwise comparisons between each adalimumab dose group and the placebo group were performed.||||<0.001
72531692|NCT00195702|144592545|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||The 3 primary efficacy variables were considered in a hierarchical order, with the ACR20 response tested first. The ACR20 response rate at Week 24 was initially assessed using Pearson's chi-squared test at a significance level of 0.05. If significant, pairwise comparisons between each adalimumab dose group and the placebo group were performed.||||<0.001
72625894|NCT03674281|144781288|SUPERIORITY|||||||0.002|||||||t-test, 2 sided|||||||0.002
72625895|NCT03674281|144781288|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
72625896|NCT00710593|144781292|SUPERIORITY_OR_OTHER||% of participants who were responders|97.5||||0.1613|TWO_SIDED|95.0|86.8|99.9|||Fisher Exact|||Historical comparison group can be referenced in: Villa et al. Immunologic responses following administration of a vaccine targeting human papillomavirus Types 6, 11, 16, and 18; Vaccine 24 (2006):5571-5583. PMID 16753240.||99.9|86.8|0.1613
72625897|NCT00710593|144781293|SUPERIORITY_OR_OTHER||% of participants who were responders|96.8||||0.0534|TWO_SIDED|95.0|89.0|99.9|||Fisher Exact|||Historical comparison group can be referenced in: Villa et al. Immunologic responses following administration of a vaccine targeting human papillomavirus Types 6, 11, 16, and 18; Vaccine 24 (2006):5571-5583. PMID 16753240.||99.9|89.0|0.0534
72625898|NCT00710593|144781294|SUPERIORITY_OR_OTHER||% of participants who were responders|96.1||||0.0427|TWO_SIDED|95.0|86.5|99.5|||Fisher Exact|||Historical comparison group can be referenced in: Villa et al. Immunologic responses following administration of a vaccine targeting human papillomavirus Types 6, 11, 16, and 18; Vaccine 24 (2006):5571-5583. PMID 16753240.||99.5|86.5|0.0427
72625899|NCT00710593|144781295|SUPERIORITY_OR_OTHER||% of participants who were responders|92.5||||0.0006|TWO_SIDED|95.0|83.4|97.5|||Fisher Exact|||Historical comparison group can be referenced in: Villa et al. Immunologic responses following administration of a vaccine targeting human papillomavirus Types 6, 11, 16, and 18; Vaccine 24 (2006):5571-5583. PMID 16753240.||97.5|83.4|0.0006
72625900|NCT00710593|144781296|SUPERIORITY_OR_OTHER||% of participants with at least 1 event|49.3||||0.8305|TWO_SIDED|95.0||||The p-value is to test the proportions of subjects with at least one event among Group A during the study at Entry, Week 8 and Week 24 after vaccine was administered.|Chi-squared, Corrected|||||||0.8305
72625901|NCT00710593|144781296|SUPERIORITY_OR_OTHER||% of participants with at least 1 event|46.7||||0.8305|TWO_SIDED|||||The p-value is to test the proportions of subjects with at least one event among Group B during the study at Entry, Week 8 and Week 24 after vaccine was administered.|Chi-squared, Corrected|||||||0.8305
72625902|NCT00710593|144781304|SUPERIORITY_OR_OTHER||Overall aquisition rate|7.9||||1||95.0|||||Fisher Exact|P-value is from the Fisher's Exact test to compare the proportion of HPV positive between two study groups.||||||1.000
72625903|NCT00710593|144781305|SUPERIORITY_OR_OTHER||Overall aquisition rate|1.6||||1||95.0||||P-value is from the Fisher's Exact test to compare the proportion of HPV positive between two study groups.|Fisher Exact|||||||1.000
72625904|NCT00710593|144781306|SUPERIORITY_OR_OTHER||Overall aquisition rate|2.0||||1||95.0||||P-value is from the Fisher's Exact test to compare the proportion of HPV positive between two study groups.|Fisher Exact|||||||1.000
72625905|NCT00710593|144781307|SUPERIORITY_OR_OTHER||Overall aquisition rate|4.5||||1||95.0||||P-value is from the Fisher's Exact test to compare the proportion of HPV positive between two study groups.|Fisher Exact|||||||1.000
72625906|NCT00710593|144781308|SUPERIORITY_OR_OTHER||Overall aquisition rate|8.3||||1||95.0||||P-value is from the Fisher's Exact test to compare the proportion of HPV positive between two study groups.|Fisher Exact|||||||1.000
72625907|NCT00710593|144781309|SUPERIORITY_OR_OTHER||Overall aquistion rate|3.6||||1||95.0||||P-value is from the Fisher's Exact test to compare the proportion of HPV positive between two study groups.|Fisher Exact|||||||1.000
72625908|NCT00710593|144781310|SUPERIORITY_OR_OTHER||Overall aquisition rate|6.3||||1||95.0||||P-value is from the Fisher's Exact test to compare the proportion of HPV positive between two study groups.|Fisher Exact|||||||1.000
72625909|NCT00710593|144781311|SUPERIORITY_OR_OTHER||Overall aquisition rate|8.1||||1||95.0||||P-value is from the Fisher's Exact test to compare the proportion of HPV positive between two study groups.|Fisher Exact|||||||1.000
72625910|NCT00710593|144781312|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.04||||0.0004|TWO_SIDED|95.0|1.02|1.1|||Regression, Logistic|||||1.1|1.02|0.0004
72625911|NCT00710593|144781313|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.05||||0.0012|TWO_SIDED|95.0|1.0|1.1|||Regression, Logistic|||||1.1|1.0|0.0012
72531693|NCT00195702|144592546|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||An ANCOVA model with baseline erosion scores as the covariate was performed. An overall significance test at alpha =0.05 was done. Pairwise comparisons, each at alpha =0.05 (2-sided), were performed if the overall test was significant.|ANCOVA|||The 3 primary efficacy variables were considered in a hierarchical order, with the change in modified total Sharp x-ray score at Week 52 tested second. Normality was evaluated by applying the Shapiro-Wilk test procedure to the residuals from the parametric model. The final analysis was performed following a non-parametric approach, ranking the results prior to fitting the model.||||<0.001
72531694|NCT00195702|144592546|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||An ANCOVA model with baseline erosion scores as the covariate was performed. An overall significance test at alpha =0.05 was done. Pairwise comparisons, each at alpha =0.05 (2-sided), were performed if the overall test was significant.|ANCOVA|||The 3 primary efficacy variables were considered in a hierarchical order, with the change in modified total Sharp x-ray score at Week 52 tested second. Normality was evaluated by applying the Shapiro-Wilk test procedure to the residuals from the parametric model. The final analysis was performed following a non-parametric approach, ranking the results prior to fitting the model.||||<0.001
72531695|NCT00195702|144592547|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||||||<0.001
72531696|NCT00195702|144592547|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||||||<0.001
72531697|NCT00195702|144592548|SUPERIORITY_OR_OTHER||||||<|0.01||95.0|||||ANCOVA|||||||<0.01
72531698|NCT00195702|144592548|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||||||<0.001
72531699|NCT00195702|144592549|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||||||<0.001
72531700|NCT00195702|144592549|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||||||<0.001
72625912|NCT00710593|144781314|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||||||<0.0001
72625913|NCT01263119|144781337|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Means|1.07|||||TWO_SIDED|90.0|1.0|1.13|||Mixed Models Analysis|||||1.13|1.00|
72625914|NCT01263119|144781338|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Means|1.12|||||TWO_SIDED|90.0|1.07|1.16|||Mixed Models Analysis|||||1.16|1.07|
72625915|NCT01263119|144781339|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.9551|TWO_SIDED|90.0|-0.5|0.5|||Wilcoxon (Mann-Whitney)|||||0.50|-0.50|0.9551
72531701|NCT00195702|144592550|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Normality was evaluated by applying the Shapiro-Wilk test to residuals from the parametric model. The final analysis was performed using a parametric approach.|ANCOVA|||The 3 primary efficacy variables were considered in a hierarchical order, with the change from baseline in the HAQ at Week 52 tested last. The difference among all treatment groups was assessed using ANCOVA with the baseline value as the covariate. If this was significant (p\<=0.05), pairwise comparisons between each adalimumab dose group and placebo were evaluated using the same method.||||<0.001
72531702|NCT00195702|144592550|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Normality was evaluated by applying the Shapiro-Wilk test to residuals from the parametric model. The final analysis was performed using a parametric approach.|ANCOVA|||The 3 primary efficacy variables were considered in a hierarchical order, with the change from baseline in the HAQ at Week 52 tested last. The difference among all treatment groups was assessed using ANCOVA with the baseline value as the covariate. If this was significant (p\<=0.05), pairwise comparisons between each adalimumab dose group and placebo were evaluated using the same method.||||<0.001
72531703|NCT00195702|144592551|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||||||<0.001
72531704|NCT00195702|144592551|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||||||<0.001
72531705|NCT00195702|144592553|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||||||<0.001
72531706|NCT00195702|144592553|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||||||<0.001
72531707|NCT00195702|144592557|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||||||<0.001
72531708|NCT00195702|144592557|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||||||<0.001
72531709|NCT02058940|144592617|OTHER|||||||0.2|||||||Spearman's Correlation Coefficient|||||||0.2
72542628|NCT00373685|144615238|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED|||||P-value associated with Overall (LOCF)|ANCOVA|||||||<0.0001
72625916|NCT01263119|144781340|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Means|1.15|||||TWO_SIDED|90.0|1.1|1.2|||Mixed Models Analysis|||||1.20|1.10|
72625917|NCT01263119|144781341|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Means|1.13|||||TWO_SIDED|90.0|1.09|1.17|||Mixed Models Analysis|||||1.17|1.09|
72625918|NCT01263119|144781342|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.6094|TWO_SIDED|90.0|-0.5|0.02|||Wilcoxon (Mann-Whitney)|||||0.02|-0.50|0.6094
72625919|NCT01263119|144781343|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Means|1.04|||||TWO_SIDED|90.0|1.02|1.05|||Mixed Models Analysis|||Least Squares (LS) geometric mean was based on pharmacodynamic AUCINR of warfarin.||1.05|1.02|
72625920|NCT01263119|144781344|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Means|1.04|||||TWO_SIDED|90.0|1.01|1.08|||Mixed Models Analysis|||Least Squares (LS) geometric mean was based on pharmacodynamic INRmax of warfarin.||1.08|1.01|
72531710|NCT01519700|144592622|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority limit: -1 day Power: 90% Confidence level: 97.5% Randomization ratio: 1:1 (EP2006:Neupogen)|Mean Difference (Net)|0.04|||||ONE_SIDED|97.5|-0.26||||||The one-sided 97.5% Confidence Interval: \[-0.26, ∞).||||-0.26|
72531711|NCT01789476|144592639|SUPERIORITY_OR_OTHER||||||<|0.05||||||One-sided ANOVA with Treatment Group as a Main Effect|ANOVA|||||||<0.05
72572200|NCT02912650|144671814|SUPERIORITY_OR_OTHER||CMH adjusted proportions|50.74|||<|0.001|TWO_SIDED|95.0|37.39|64.09|||Cochran-Mantel-Haenszel|||6 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||64.09|37.39|<0.001
72572201|NCT02912650|144671814|SUPERIORITY_OR_OTHER||CMH adjusted proportions|43.16|||<|0.001|TWO_SIDED|95.0|29.56|56.75|||Cochran-Mantel-Haenszel|||6 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||56.75|29.56|<0.001
72572202|NCT02912650|144671814|SUPERIORITY_OR_OTHER||CMH adjusted proportions|7.91||||0.087|TWO_SIDED|95.0|-1.15|16.97|||Cochran-Mantel-Haenszel|||6 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||16.97|-1.15|0.087
72572203|NCT02912650|144671814|SUPERIORITY_OR_OTHER||CMH adjusted proportions|58.12|||<|0.001|TWO_SIDED|95.0|45.24|71.0|||Cochran-Mantel-Haenszel|||7 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||71.00|45.24|<0.001
72625921|NCT01664624|144781365|SUPERIORITY_OR_OTHER||LS Mean Difference|-5.1|STANDARD_ERROR_OF_MEAN|5.82||0.388|TWO_SIDED|95.0|-16.9|6.7||The comparison was evaluated at the 5% level of significance.|ANCOVA|ANCOVA model with treatment as fixed effect, and baseline Postprandial AUC (0-8) of active GLP-1 as a continuous covariate.||ANCOVA was used to test the null hypothesis that the change from Baseline in the postprandial AUC(0-8) of active GLP-1 is no difference between the roflumilast + alogliptin and alogliptin alone.||6.7|-16.9|0.388
72625922|NCT01664624|144781365|SUPERIORITY_OR_OTHER||LS Mean Difference|22.7|STANDARD_ERROR_OF_MEAN|5.7|<|0.001|TWO_SIDED|95.0|11.1|34.3||The comparison was evaluated at the 5% level of significance.|ANCOVA|ANCOVA model with treatment as fixed effect, and Baseline Postprandial AUC (0-8) of active GLP-1 as a continuous covariate.||ANCOVA was used to test the null hypothesis that the change from Baseline in the postprandial AUC(0-8) of active GLP-1 is no difference between the roflumilast + alogliptin and roflumilast alone.||34.3|11.1|<0.001
72531712|NCT01789476|144592640|SUPERIORITY_OR_OTHER||||||<|0.03||||||One-sided ANOVA with Treatment Group as a Main Effect|ANOVA|||||||<0.03
72531713|NCT01789476|144592641|SUPERIORITY_OR_OTHER||||||<|0.03||||||One-sided ANOVA with Treatment Group as a Main Effect|ANOVA|||||||<0.03
72572204|NCT02912650|144671814|SUPERIORITY_OR_OTHER||CMH adjusted proportions|7.23||||0.071|TWO_SIDED|95.0|-0.63|15.1|||Cochran-Mantel-Haenszel|||7 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||15.10|-0.63|0.071
72572205|NCT02912650|144671814|SUPERIORITY_OR_OTHER||CMH adjusted proportions|15.12|||<|0.001|TWO_SIDED|95.0|6.55|23.69|||Cochran-Mantel-Haenszel|||7 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||23.69|6.55|<0.001
72572206|NCT02912650|144671814|SUPERIORITY_OR_OTHER||CMH adjusted proportions|50.74|||<|0.001|TWO_SIDED|95.0|37.39|64.09|||Cochran-Mantel-Haenszel|||7 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||64.09|37.39|<0.001
72572207|NCT02912650|144671814|SUPERIORITY_OR_OTHER||CMH adjusted proportions|43.16|||<|0.001|TWO_SIDED|95.0|29.56|56.75|||Cochran-Mantel-Haenszel|||7 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||56.75|29.56|<0.001
72572208|NCT02912650|144671814|SUPERIORITY_OR_OTHER||CMH adjusted proportions|7.91||||0.087|TWO_SIDED|95.0|-1.15|16.97|||Cochran-Mantel-Haenszel|||7 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||16.97|-1.15|0.087
72572209|NCT02912650|144671814|SUPERIORITY_OR_OTHER||CMH adjusted proportions|58.12|||<|0.001|TWO_SIDED|95.0|45.24|71.0|||Cochran-Mantel-Haenszel|||8 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||71.00|45.24|<0.001
72531714|NCT00965458|144592642|SUPERIORITY_OR_OTHER|||||||0.065|TWO_SIDED|||||P-value is for testing treatment effect using an analysis of covariance with baseline ln(AUC+1) as a covariate and change in ln(AUC+1) from baseline as the outcome variable.|ANCOVA|||Primary imputation method used for missing Month 12 AUC. Measuring range for C-peptide is 0.05-30 ng/mL.||||0.065
72531715|NCT00965458|144592643|SUPERIORITY_OR_OTHER|||||||0.019|TWO_SIDED|||||P-value is for testing treatment effect using an analysis of covariance with baseline In(AUC+1) as a covariate and change in In(AUC+1) from baseline as the outcome|ANCOVA|||Primary imputation method used for missing Week 52 AUC. Measuring range for C-peptide is 0.05-30 ng/mL||||0.019
72531716|NCT00965458|144592643|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED|||||P-value is for testing treatment effect using an analysis of covariance with baseline In(AUC+1) as a covariate and change in In(AUC+1) from baseline as the outcome|ANCOVA|||Primary imputation method used for missing Week 104 AUC. Measuring range for C-peptide is 0.05-30 ng/mL||||0.002
72531717|NCT00965458|144592644|SUPERIORITY_OR_OTHER|||||||0.065|TWO_SIDED|||||P-value is for testing treatment effect using an analysis of covariance with baseline In(AUC+1) as a covariate and change in In(AUC+1) from baseline as the outcome|ANCOVA|||Primary imputation method used for missing Week 52 AUC. Measuring range for C-peptide is 0.05-30 ng/mL||||0.065
72531718|NCT00965458|144592644|SUPERIORITY_OR_OTHER|||||||0.015|TWO_SIDED|||||P-value is for testing treatment effect using an analysis of covariance with baseline In(AUC+1) as a covariate and change in In(AUC+1) from baseline as the outcome|ANCOVA|||Primary imputation method used for missing Week 104 AUC. Measuring range for C-peptide is 0.05-30 ng/mL||||0.015
72625923|NCT01664624|144781365|SUPERIORITY_OR_OTHER||LS Mean Difference|28.8|STANDARD_ERROR_OF_MEAN|5.76|<|0.001|TWO_SIDED|95.0|17.1|40.5||The comparison was evaluated at the 5% level of significance.|ANCOVA|ANCOVA model with treatment as fixed effect, and Baseline Postprandial AUC (0-8) of active GLP-1 as a continuous covariate.||ANCOVA was used to test the null hypothesis that the change from Baseline in the postprandial AUC(0-8) of active GLP-1 is no difference between the roflumilast + alogliptin and roflumilast alone.||40.5|17.1|<0.001
72625924|NCT00127439|144781371|NON_INFERIORITY_OR_EQUIVALENCE|The power analysis indicated that when the mean difference equals to 1.2 times of standard deviation, a two-sided t-test at 0.05 level will have 80% power; and for a mean difference of 1.4 times of standard deviation the power increases to 91%. To test the null hypothesis that correlation will be 0 at 0.5 level, a two-sided test based on Fisher's Z transformation will yield a power of 89% in detecting correlations of 0.6 or above with n=24 or above.||||||0.05|||||||t-test, 2 sided|||||||0.05
72625925|NCT00127439|144781371|SUPERIORITY_OR_OTHER|||||||0.05|||||||Wilcoxon rank sum test|||Pearson correlation of gait speed changes with directional difference of standardized kinematic scores (i.e. foot trajectory toe-off - degrees, foot trajectory toe-off - % cycle, foot trajectory initial contact - degrees, foot trajectory range - degrees, propulsive impulse N-s, minimum thigh angle - flexion degrees, minimum hip angle - extension degrees, trunk angle mid-stance)||||0.05
72625926|NCT00127439|144781372|NON_INFERIORITY_OR_EQUIVALENCE|Previously provided||||||0.05|||||||t-test, 2 sided|||||||0.05
72531719|NCT00965458|144592645|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED|||||P-value is for testing treatment effect using an analysis of covariance with baseline level as a covariate and change from baseline as the outcome variable|ANCOVA|||Week 52 mean insulin use comparison||||0.020
72531720|NCT00965458|144592645|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED|||||P-value is for testing treatment effect using an analysis of covariance with baseline level as a covariate and change from baseline as the outcome variable|ANCOVA|||Week 104 mean insulin use comparison||||0.002
72531721|NCT00965458|144592646|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||P-value is from a poisson regression comparing the person-year adjusted event rates between the two treatment groups|Regression, Logistic|||Hypoglycemic Events Occurring from Baseline to Week 52||||<0.001
72531722|NCT00965458|144592646|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||P-value is from a poisson regression comparing the person-year adjusted event rates between the two treatment groups|Regression, Logistic|||Hypoglycemic Events Occurring from Week 52 to Week 104||||<0.001
72531723|NCT00965458|144592647|SUPERIORITY_OR_OTHER|||||||0.746|TWO_SIDED|||||P-value is for testing treatment effect using an analysis of covariance with baseline level as a covariate and change from baseline as the outcome variable|ANCOVA|||Week 52 mean HbA1C comparison||||0.746
72531724|NCT00965458|144592647|SUPERIORITY_OR_OTHER|||||||0.942|TWO_SIDED|||||P-value is for testing treatment effect using an analysis of covariance with baseline level as a covariate and change from baseline as the outcome variable|ANCOVA|||Week 104 mean HbA1C comparison||||0.942
72531725|NCT00692198|144592668|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.94||||0.52|TWO_SIDED|95.0|0.79|1.12|||Log Rank|||||1.12|0.79|0.52
72531726|NCT00692198|144592669|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.9||||0.53|TWO_SIDED|95.0|0.64|1.25|||Log Rank||Hazard ratio, LTOT vs No LTOT|||1.25|0.64|0.53
72531727|NCT00692198|144592670|SUPERIORITY_OR_OTHER||Rate ratio|1.01||||0.81|TWO_SIDED|95.0|0.91|1.13|||Fisher Exact||Rate ratio, LTOT vs No LTOT|||1.13|0.91|0.81
72531728|NCT00692198|144592672|SUPERIORITY_OR_OTHER||Rate ratio|1.08||||0.12|TWO_SIDED|95.0|0.98|1.19|||Fisher Exact||Rate ratio, LTOT vs No LTOT|||1.19|0.98|0.12
72531729|NCT00692198|144592673|SUPERIORITY_OR_OTHER|||||||0.73|||||||t-test, 2 sided|||||||0.73
72531730|NCT00692198|144592674|SUPERIORITY_OR_OTHER|||||||0.21|||||||t-test, 2 sided|||||||0.21
72625927|NCT00127439|144781373|NON_INFERIORITY_OR_EQUIVALENCE|Provided previously||||||0.05|||||||t-test, 2 sided|||||||0.05
72625928|NCT00127439|144781374|NON_INFERIORITY_OR_EQUIVALENCE|Provided previously||||||0.05|||||||t-test, 2 sided|||||||0.05
72625929|NCT00127439|144781375|NON_INFERIORITY_OR_EQUIVALENCE|Previously provided||||||0.05|||||||t-test, 2 sided|||||||0.05
72625930|NCT00127439|144781376|NON_INFERIORITY_OR_EQUIVALENCE|Previously provided||||||0.05|||||||t-test, 2 sided|||||||0.05
72625931|NCT00127439|144781377|NON_INFERIORITY_OR_EQUIVALENCE|Previously provided||||||0.05|||||||t-test, 2 sided|||||||0.05
72625932|NCT00127439|144781378|NON_INFERIORITY_OR_EQUIVALENCE|Previously provided||||||0.05|||||||t-test, 2 sided|||||||0.05
72625933|NCT00127439|144781379|NON_INFERIORITY_OR_EQUIVALENCE|Previously provided||||||0.05|||||||t-test, 2 sided|||||||0.05
72531731|NCT00692198|144592675|SUPERIORITY_OR_OTHER|||||||0.71|||||||t-test, 2 sided|||||||0.71
72531732|NCT00692198|144592676|SUPERIORITY_OR_OTHER|||||||0.03|||||||t-test, 2 sided|||||||0.03
72531733|NCT00692198|144592677|SUPERIORITY_OR_OTHER|||||||0.28|||||||t-test, 2 sided|||||||0.28
72531734|NCT00692198|144592678|SUPERIORITY_OR_OTHER|||||||0.41|||||||t-test, 2 sided|||||||0.41
72531735|NCT00692198|144592679|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|2.09|||||TWO_SIDED|95.0|0.54|8.0|||||Relative risk, LTOT vs No LTOT|||8.00|0.54|
72531736|NCT00692198|144592680|SUPERIORITY_OR_OTHER|||||||0.37|||||||t-test, 2 sided|||||||0.37
72531737|NCT00692198|144592681|SUPERIORITY_OR_OTHER|||||||0.21|||||||t-test, 2 sided|||||||0.21
72531738|NCT03039686|144592685|SUPERIORITY||Mean Difference (Final Values)|-0.45|STANDARD_ERROR_OF_MEAN|0.87|||TWO_SIDED|95.0|-2.17|1.27|||||Based on the MMRM using an unstructured covariance matrix -change = Baseline + Age Interactive response system (IXRS) Stratum + Corticosteroid Regimen IXRS Stratum + Analysis Visit\*Treatment.|||1.27|-2.17|
72531739|NCT03039686|144592685|SUPERIORITY||Mean Difference (Final Values)|0.58|STANDARD_ERROR_OF_MEAN|0.85|||TWO_SIDED|95.0|-1.1|2.26|||||Based on the MMRM using an unstructured covariance matrix -change = Baseline + Age IXRS Stratum + Corticosteroid Regimen IXRS Stratum + Analysis Visit\*Treatment.|||2.26|-1.10|
72625934|NCT04067011|144781384|EQUIVALENCE|The equivalence testing was constructed using paired two one-sided t-tests (TOST) with natural log transformation of PK parameters. Results obtained from transformed analyses were back-transformed by exponentiation for presentation of the point estimates and 90% CIs for geometric mean ratio of AUC0-12h.|Ratio of AUC|0.9764|||||TWO_SIDED|90.0|0.8895|1.0718||||||Analysis of Geometric mean ratio of area under the curve from 0 to 12 hours (AUC0-12h) for ciprofloxacin on Days 8 and 35||1.0718|0.8895|
72625935|NCT04067011|144781384|EQUIVALENCE|The equivalence testing was constructed using paired two one-sided t-tests (TOST) with natural log transformation of PK parameters. Results obtained from transformed analyses were back-transformed by exponentiation for presentation of the point estimates and 90% CIs for geometric mean ratio of Cmax.|Ratio of Cmax|0.9706|||||TWO_SIDED|90.0|0.8693|1.0838||||||Analysis of Geometric mean ration of Cmax for ciprofloxacin on Days 8 and 35||1.0838|0.8693|
72408003|NCT03238911|144324423|SUPERIORITY||Mean Difference (Final Values)|1.03|||<|0.0001|TWO_SIDED|95.0|0.81|1.25|||Mixed model for repeated measures|||"Day 8~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||1.25|0.81|<0.0001
72531740|NCT03039686|144592687|SUPERIORITY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.1|||TWO_SIDED|95.0|-0.21|0.2|||||Based on the MMRM using an unstructured covariance matrix - change = Baseline + Age IXRS Stratum + Corticosteroid Regimen IXRS Stratum + Analysis Visit\*Treatment.|||0.20|-0.21|
72531741|NCT03039686|144592687|SUPERIORITY||Mean Difference (Final Values)|0.08|STANDARD_ERROR_OF_MEAN|0.1|||TWO_SIDED|95.0|-0.12|0.27|||||Based on the MMRM using an unstructured covariance matrix - change = Baseline + Age IXRS Stratum + Corticosteroid Regimen IXRS Stratum + Analysis Visit\*Treatment.|||0.27|-0.12|
72531742|NCT03039686|144592689|SUPERIORITY||Mean Difference (Final Values)|0.03|STANDARD_ERROR_OF_MEAN|0.02|||TWO_SIDED|95.0|0.0|0.06|||||Based on the MMRM using an unstructured covariance matrix - change = Baseline + Age IXRS Stratum + Corticosteroid Regimen IXRS Stratum + Analysis Visit\*Treatment.|||0.06|-0.00|
72531743|NCT03039686|144592689|SUPERIORITY||Mean Difference (Final Values)|0.03|STANDARD_ERROR_OF_MEAN|0.02|||TWO_SIDED|95.0|0.0|0.06|||||Based on the MMRM using an unstructured covariance matrix - change = Baseline + Age IXRS Stratum + Corticosteroid Regimen IXRS Stratum + Analysis Visit\*Treatment.|||0.06|-0.00|
72531744|NCT03039686|144592691|SUPERIORITY||Mean Difference (Final Values)|0.09|STANDARD_ERROR_OF_MEAN|0.09|||TWO_SIDED|95.0|-0.08|0.27|||||Based on the MMRM using an unstructured covariance matrix - change = Baseline + Age IXRS Stratum + Corticosteroid Regimen IXRS Stratum + Analysis Visit\*Treatment.|||0.27|-0.08|
72531745|NCT03039686|144592691|SUPERIORITY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.09|||TWO_SIDED|95.0|-0.17|0.18|||||Based on the MMRM using an unstructured covariance matrix - change = Baseline + Age IXRS Stratum + Corticosteroid Regimen IXRS Stratum + Analysis Visit\*Treatment.|||0.18|-0.17|
72531746|NCT03039686|144592693|SUPERIORITY||Mean Difference (Final Values)|-2.0|STANDARD_ERROR_OF_MEAN|2.41|||TWO_SIDED|95.0|-6.76|2.77|||||Based on the MMRM using an unstructured covariance matrix - change = Baseline + Age IXRS Stratum + Corticosteroid Regimen IXRS Stratum + Analysis Visit\*Treatment.|||2.77|-6.76|
72531747|NCT03039686|144592693|SUPERIORITY||Mean Difference (Final Values)|0.96|STANDARD_ERROR_OF_MEAN|2.36|||TWO_SIDED|95.0|-3.71|5.63|||||Based on the MMRM using an unstructured covariance matrix - change = Baseline + Age IXRS Stratum + Corticosteroid Regimen IXRS Stratum + Analysis Visit\*Treatment.|||5.63|-3.71|
72531748|NCT03039686|144592696|SUPERIORITY||Mean Difference (Final Values)|1.7|STANDARD_ERROR_OF_MEAN|11.5|||TWO_SIDED|95.0|-21.1|24.6|||||Based on the MMRM using an unstructured covariance matrix - change = Baseline + Age IXRS Stratum + Corticosteroid Regimen IXRS Stratum + Analysis Visit\*Treatment.|||24.6|-21.1|
72531749|NCT03039686|144592696|SUPERIORITY||Mean Difference (Final Values)|11.3|STANDARD_ERROR_OF_MEAN|11.3|||TWO_SIDED|95.0|-11.0|33.6|||||Based on the MMRM using an unstructured covariance matrix - change = Baseline + Age IXRS Stratum + Corticosteroid Regimen IXRS Stratum + Analysis Visit\*Treatment.|||33.6|-11.0|
72531750|NCT04250558|144592707|OTHER|||||||0.05|||||||Regression, Logistic|||Kinetic parameters were assessed by Mann-Whitney U test in MATLAB Statistics and Machine Learning Toolbox. Receiver operating characteristic (ROC) analysis based on logistic regression was utilized, with one surgical condition versus the other two states as the binary dependent variable, and each perfusion-related kinetic parameter of Imax, IS and BF as the independent variable. Power analysis was performed to evaluate the statistical validity, using G\*Power software||||0.05
72531751|NCT00772031|144592710|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.3|STANDARD_ERROR_OF_MEAN|0.97||0.77|TWO_SIDED|95.0|-1.8|2.4|||ANCOVA|covariate adjustments: study site, baseline mod-to-sev 28-day headache-rate, topiramate use, medication overuse, and anti-depressive medications use.|Topiramate plus placebo mean reduction minus topiramate plus propranolol reduction|The study was designed to enroll 250 subjects to provide at least 90% power to detect a 3-day difference and 87% power to detect a 2.5-day difference in 28-day moderate-to-severe headache rate reductions at six months, assuming a type I error rate of 0.05, a two-sided test, a 10% loss to follow-up and a standard deviation of within-person change in days with headache of six.||2.4|-1.8|0.77
72531752|NCT00772031|144592711|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.44|||||TWO_SIDED|95.0|0.75|2.78||||||||2.78|0.75|
72531753|NCT00772031|144592712|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.0||||||95.0|0.5|2.02||||||||2.02|0.50|
72531754|NCT00772031|144592714|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.28|STANDARD_DEVIATION|3.75||0.91||95.0|||||ANCOVA|||||||0.91
72531755|NCT00656136|144592718|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.077||||0.7428|TWO_SIDED|95.0|0.862|1.346||P-value is one-sided (afatinib vs placebo) log rank test stratified by gender and baseline ECOG score (0,1 vs 2)|Regression, Cox|Model stratified by gender and baseline ECOG score (0,1 vs 2)||Primary analysis was performed after 358 deaths were observed among randomized patients. The data cut-off date for the primary analysis was 08 July 2010.||1.346|0.862|0.7428
72531756|NCT00656136|144592718|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.976||||0.3955|TWO_SIDED|95.0|0.814|1.17||P-value is one-sided (afatinib vs placebo) log rank test stratified by gender and baseline ECOG score (0,1 vs 2)|Regression, Cox|Model stratified by gender and baseline ECOG score (0,1 vs 2)||Final analysis was performed after 526 deaths were observed among randomized patients. The data cut-off date for the final analysis was 04 October 2013.||1.170|0.814|0.3955
72531757|NCT00656136|144592719|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.381|||<|0.0001|TWO_SIDED|95.0|0.306|0.475||P-value is one-sided (afatinib vs placebo) log rank test stratified by gender and baseline ECOG score (0,1 vs 2)|Regression, Cox|Model stratified by gender and baseline ECOG score (0,1 vs 2)||||0.475|0.306|<0.0001
72542629|NCT00373685|144615239|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0023|TWO_SIDED|||||P-value associated with Overall (LOCF)|Cochran-Mantel-Haenszel|||||||0.0023
72625936|NCT04067011|144781385|EQUIVALENCE|The equivalence testing was constructed using paired two one-sided t-tests (TOST) with natural log transformation of PK parameters. Results obtained from transformed analyses were back-transformed by exponentiation for presentation of the point estimates and 90% CIs for geometric mean ratio of AUC0-12h.|Ratio of AUC|0.9173|||||TWO_SIDED|90.0|0.8187|1.0278||||||Analysis of Geometric mean ratio of Area under the curve from 0 to 12 hours (AUC0-12h) for doxycycline on Days 8 and 38||1.0278|0.8187|
72625937|NCT04067011|144781385|EQUIVALENCE|The equivalence testing was constructed using paired two one-sided t-tests (TOST) with natural log transformation of PK parameters. Results obtained from transformed analyses were back-transformed by exponentiation for presentation of the point estimates and 90% CIs for geometric mean ratio of Cmax.|Ratio of Cmax|0.8974|||||TWO_SIDED|90.0|0.7841|1.0271||||||Analysis of Geometric mean ration of Cmax for doxycycline on Days 8 and 38||1.0271|0.7841|
72625938|NCT04067011|144781386|NON_INFERIORITY|Non-inferiority margin is 0.5.|Ratio of GMT (Group 1/Group 3)|1.13|||||TWO_SIDED|95.0|0.78|1.64||||||||1.64|0.78|
72625939|NCT04067011|144781386|NON_INFERIORITY|Non-inferiority margin is 0.5.|Ratio of GMT (Group 2/Group 3)|1.14|||||TWO_SIDED|95.0|0.81|1.6||||||||1.6|0.81|
72625940|NCT05209386|144781387|OTHER||||||||||||||||||Permutation-based clustering analysis was used to identify channels that significantly encode change in acoustic dimensions. For each channel, a sliding-window encoding model was built comparing evoked responses (z-scored voltages) to Canonical Block stimuli across varying F0 with fixed VOT. This analysis identified the n = 17 channels and time windows where neural responses differed according to change in F0.|||
72625941|NCT05209386|144781388|OTHER||||||<|0.0001|||||||t-test, 2 sided|t(20.45) = -5.8||||||<0.0001
72625942|NCT05209386|144781389|OTHER||||||<|0.0001|||||||Mixed Models Analysis|For interaction term (effect of interest): t(1016) = -2.7|||Time-averaged neural responses across respective windows of significance were averaged for all stimuli with ambiguous VOT (Canonical and Reverse blocks) to provide trial-averaged responses. A single linear mixed-effects model was built with fixed effects of F0, condition/listening context (block), and their interaction, as well as a random effect (intercept only) of patient+channel. The effect of interest was the interaction term, indicating that neural responses to F0 varied according to listening context (block).|||<0.0001
72625943|NCT05209386|144781390|OTHER||||||<|0.0001|||||||Mixed Models Analysis|t(48) = -4.50||The null hypothesis is that there is no effect of change in listening context on behavioral responses of participants.||||<0.0001
72625944|NCT05209386|144781391|OTHER||||||||||||||||||Permutation-based clustering analysis was used to identify channels in non-regions of interest that significantly encode change in acoustic dimensions. For each channel, a sliding-window encoding model was built comparing evoked responses (z-scored voltages) to Canonical Block stimuli across varying F0 with fixed VOT. This analysis identified the n = 4 channels and time windows where neural responses differed according to change in F0.|||
72625945|NCT05209386|144781392|OTHER|||||||0.48|||||||Mixed Models Analysis|For interaction term (effect of interest): t(216) = -0.707|||Time-averaged neural responses across respective windows of significance were averaged for all stimuli with ambiguous VOT (Canonical and Reverse blocks) to provide trial-averaged responses. A single linear mixed-effects model was built with fixed effects of F0, condition/listening context (block), and their interaction, as well as a random effect (intercept only) of patient+channel. The effect of interest was the interaction term, indicating that neural responses to F0 varied according to listening context (block).|||0.480
72625946|NCT00432965|144781436|SUPERIORITY||Odds Ratio (OR)|1.89||||0.007|TWO_SIDED|95.0|1.19|3.02|||Fisher Exact|||Time Frame: Days 0-114||3.02|1.19|0.007
72625947|NCT03330847|144781453|SUPERIORITY||Hazard Ratio (HR)|1.02||||0.9403|TWO_SIDED|90.0|0.63|1.66|||Two-sided log-rank tests|Stratified for prior platinum-based therapy (no,yes) using Breslow's approach for handling of ties.|Proportional hazards models based on prior platinum-based therapy (no, yes). Hazard ratio \< 1 favours respective combination treatment related with a longer PFS than olaparib monotherapy. Here, favours olaparib monotherapy.|Patient Population BRCAm||1.66|0.63|0.9403
72625948|NCT03330847|144781453|SUPERIORITY||Hazard Ratio (HR)|1.01||||0.9282|TWO_SIDED|90.0|0.52|1.88|||Two-sided log-rank tests|Stratified for prior platinum-based therapy (no,yes) using Breslow's approach for handling of ties.|Proportional hazards models based on prior platinum-based therapy (no, yes). Hazard ratio \< 1 favours respective combination treatment related with a longer PFS than olaparib monotherapy. Here, favours olaparib monotherapy.|Patient Population BRCAm||1.88|0.52|0.9282
72625949|NCT03330847|144781453|SUPERIORITY||Hazard Ratio (HR)|0.54||||0.1274|TWO_SIDED|90.0|0.28|1.03|||Two-sided log-rank tests|Stratified for prior platinum-based therapy (no,yes) using Breslow's approach for handling of ties.|Proportional hazards models based on prior platinum-based therapy (no, yes). Hazard ratio \< 1 favours respective combination treatment related with a longer PFS than olaparib monotherapy. Here, favours olaparib + ceralasertib.|Patient Population Non BRCAm HRRm||1.03|0.28|0.1274
72625950|NCT03330847|144781453|SUPERIORITY||Hazard Ratio (HR)|0.56||||0.2956|TWO_SIDED|90.0|0.23|1.26|||Two-sided log-rank tests|Stratified for prior platinum-based therapy (no,yes) using Breslow's approach for handling of ties.|Proportional hazards models based on prior platinum-based therapy (no, yes). Hazard ratio \< 1 favours respective combination treatment related with a longer PFS than olaparib monotherapy. Here, favours olaparib + adavosertib.|Patient Population Non BRCAm HRRm||1.26|0.23|0.2956
72531758|NCT00656136|144592720|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|15.61||||0.0071|TWO_SIDED|95.0|2.1|115.0||P-value is derived from logistic regression model adjusted for stratification factors, gender and baseline ECOG score (0, 1 vs 2)|Regression, Logistic|Model stratified by gender and baseline ECOG score (0,1 vs 2)||||115|2.1|0.0071
72531759|NCT01101321|144592750|NON_INFERIORITY_OR_EQUIVALENCE|A mixed-model analysis of variance was used to compare (test vs reference) and the 90% confidence intervals were estimated for the ratios (test/reference)|Geometric Test/Ref Ratio x 100|100.0|||||TWO_SIDED|90.0|96.14|104.96|||ANOVA||Bioequivalence is established when 90% Confidence Interval falls within 80%-125%.|||104.96|96.14|
72531760|NCT01101321|144592751|NON_INFERIORITY_OR_EQUIVALENCE|A mixed-model analysis of variance was used to compare (test vs reference) and the 90% confidence intervals were estimated for the ratios (test/reference)|Geometric Test/Ref Ratio x 100|98.5|||||TWO_SIDED|90.0|95.44|101.73|||ANOVA||Bioequivalence is established when 90% Confidence Interval falls within 80%-125%.|||101.73|95.44|
72542630|NCT00373685|144615240|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1008|TWO_SIDED||||||Chi-squared|||Baseline||||0.1008
72542631|NCT00373685|144615240|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||Chi-squared|||Week 8||||<0.0001
72625951|NCT03330847|144781453|SUPERIORITY||Hazard Ratio (HR)|0.76||||0.2959|TWO_SIDED|90.0|0.5|1.14|||Two-sided log-rank tests|Stratified for prior platinum-based therapy (no,yes) using Breslow's approach for handling of ties.|Proportional hazards models based on prior platinum-based therapy (no, yes). Hazard ratio \< 1 favours respective combination treatment related with a longer PFS than olaparib monotherapy. Here, favours olaparib + ceralasertib.|Patient Population Non HRRm||1.14|0.50|0.2959
72531761|NCT01101321|144592752|NON_INFERIORITY_OR_EQUIVALENCE|A mixed-model analysis of variance was used to compare (test vs reference) and the 90% confidence intervals were estimated for the ratios (test/reference)|Geometric Test/Ref Ratio x 100|98.5|||||TWO_SIDED|90.0|95.42|101.7|||ANOVA||Bioequivalence is established when 90% Confidence Interval falls within 80%-125%.|||101.70|95.42|
72531762|NCT02681094|144592753|SUPERIORITY||LS mean difference|-0.4|||<|0.0001|TWO_SIDED|95.0|-0.55|-0.24|||Mixed Models Analysis|||||-0.24|-0.55|<0.0001
72531763|NCT02681094|144592753|SUPERIORITY||LS mean difference|-0.34|||<|0.0001|TWO_SIDED|95.0|-0.5|-0.19|||Mixed Models Analysis|||||-0.19|-0.50|<0.0001
72531764|NCT02681094|144592754|SUPERIORITY||Risk Difference (RD)|19.8|||<|0.0001|TWO_SIDED|95.0|12.7|26.9|||Method of Zhang, Tsiatis, and Davidian|||||26.9|12.7|<0.0001
72531765|NCT02681094|144592754|SUPERIORITY||Risk Difference (RD)|11.7||||0.0018|TWO_SIDED|95.0|4.4|19.1|||Method of Zhang, Tsiatis, and Davidian|||||19.1|4.4|0.0018
72531766|NCT02681094|144592755|SUPERIORITY||LS mean difference|-7.58||||0.0135|TWO_SIDED|95.0|-13.59|-1.57|||Mixed Models Analysis|||||-1.57|-13.59|0.0135
72531767|NCT02681094|144592755|SUPERIORITY||LS mean difference|-14.88|||<|0.0001|TWO_SIDED|95.0|-20.85|-8.91|||Mixed Models Analysis|||||-8.91|-20.85|<0.0001
72531768|NCT02681094|144592756|SUPERIORITY||LS mean difference|-1.6|||<|0.0001|TWO_SIDED|95.0|-2.11|-1.09|||Mixed Models Analysis|||||-1.09|-2.11|<0.0001
72531769|NCT01270139|144592757|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The sample size was not defined on the basis of an end-point hypothesis, therefore the present FIM study should be considered as hypothesis-generating.|||||<|0.05|TWO_SIDED|||||Overall comparison was assessed by applying the Friedman test, and pairwise comparisons between post-procedure and follow-up (nano vs ferro, nano vs stenting, and ferro vs stenting) were performed by ANOVA.|ANOVA|||Null hypothesis - Nano group is superior to Ferro group and stenting control||||<0.05
72531770|NCT01270139|144592758|OTHER|The Kolmogorov-Smirnov test was used to prove Gaussian distribution allowing for calculation of the mean and standard deviation. Non-Gaussian samples are described by median and range. Discriminant variables are evaluated with the two-sided Fisher's exact test. Differences between three groups were analyzed by means of a repeated-measures oneway ANOVA followed by a Fisher's post hoc test. We used the Cox proportional hazards ratios (HR) and 95% CI for the end points.|||||<|0.05||||||"A p value was calculated for each comparison separately, and indicated as for all comparisons. In case if p value was \>0.05, it was mentioned with a separated info. The threshold for statistical significance was a p value below 0.05."|Kaplan-Meier|||Null hypothesis is Nano group is superior to Ferro group and stenting control.||||<0.05
72625952|NCT03330847|144781453|SUPERIORITY||Hazard Ratio (HR)|0.48||||0.0193|TWO_SIDED|90.0|0.28|0.8|||Two-sided log-rank tests|Stratified for prior platinum-based therapy (no,yes) using Breslow's approach for handling of ties.|Proportional hazards models based on prior platinum-based therapy (no, yes). Hazard ratio \< 1 favours respective combination treatment related with a longer PFS than olaparib monotherapy. Here, favours olaparib + adavosertib.|Patient Population Non HRRm||0.80|0.28|0.0193
72531771|NCT01270139|144592759|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The sample size was not defined on the basis of an end-point hypothesis, therefore the present FIM study should be considered as hypothesis-generating.|||||<|0.05|TWO_SIDED|||||Overall comparison was assessed by applying the Friedman test, and pairwise comparisons between post-procedure and follow-up (nano vs ferro, nano vs stenting, and ferro vs stenting) were performed by ANOVA.|ANOVA|||Null hypothesis - Nano group is superior to Ferro group and stenting control||||<0.05
72531772|NCT01270139|144592760|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The sample size was not defined on the basis of an end-point hypothesis, therefore the present FIM study should be considered as hypothesis-generating.|||||<|0.05|TWO_SIDED||||||Kaplan-Meier|||Null hypothesis is Nano group is superior to Ferro group and stenting control||||<0.05
72531773|NCT01270139|144592761|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The sample size was not defined on the basis of an end-point hypothesis, therefore the present FIM study should be considered as hypothesis-generating.|||||<|0.05|ONE_SIDED||||||Chi-squared|||The null hypothesis is Nano group is superior to Ferro group and Stenting control||||<0.05
72531774|NCT01270139|144592762|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The sample size was not defined on the basis of an end-point hypothesis, therefore the present FIM study should be considered as hypothesis-generating.|||||<|0.05|ONE_SIDED||||||Chi-squared|||The null hypothesis is Nano group is superior to Ferro group and Stenting control||||<0.05
72531775|NCT01270139|144592763|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The sample size was not defined on the basis of an end-point hypothesis, therefore the present FIM study should be considered as hypothesis-generating.|||||<|0.05|TWO_SIDED|||||Overall comparison was assessed by applying the Friedman test, and pairwise comparisons between post-procedure and follow-up (nano vs ferro, nano vs stenting, and ferro vs stenting) were performed by ANOVA.|ANOVA|||The null hypothesis is Nano group is superior to Ferro group and stenting control||||<0.05
72531776|NCT01270139|144592764|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The sample size was not defined on the basis of an end-point hypothesis, therefore the present FIM study should be considered as hypothesis-generating.|||||<|0.05|TWO_SIDED|||||Overall comparison was assessed by applying the Friedman test, and pairwise comparisons between post-procedure and follow-up (nano vs ferro, nano vs stenting, and ferro vs stenting) were performed by ANOVA.|ANOVA|||The null hypothesis is Nanogroup is superior to Ferro group and stenting control||||<0.05
72531777|NCT01270139|144592765|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The sample size was not defined on the basis of an end-point hypothesis, therefore the present FIM study should be considered as hypothesis-generating.|||||<|0.05|TWO_SIDED||||||Chi-squared|||The null hypothesis is Nanogroup is superior to Ferro group and stenting control||||<0.05
72531778|NCT01270139|144592766|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The sample size was not defined on the basis of an end-point hypothesis, therefore the present FIM study should be considered as hypothesis-generating.|||||<|0.05|TWO_SIDED|||||Overall comparison was assessed by applying the Friedman test, and pairwise comparisons between post-procedure and follow-up (nano vs ferro, nano vs stenting, and ferro vs stenting) were performed by ANOVA.|ANOVA|||The null hypothesis is Nano group is superior to Ferro group and stenting control||||<0.05
72625953|NCT03330847|144781454|SUPERIORITY||Hazard Ratio (HR)|0.87||||0.6147|TWO_SIDED|90.0|0.53|1.39|||Two-sided log-rank tests|Stratified for prior platinum-based therapy (no,yes) using Breslow's approach for handling of ties.|Proportional hazards models based on prior platinum-based therapy (no, yes). Hazard ratio \< 1 favours respective combination treatment related with a longer PFS than olaparib monotherapy. Here, favours olaparib + ceralasertib.|Patient Population BRCAm||1.39|0.53|0.6147
72625954|NCT03330847|144781454|SUPERIORITY||Hazard Ratio (HR)|0.93||||0.7879|TWO_SIDED|90.0|0.48|1.68|||Two-sided log-rank tests|Stratified for prior platinum-based therapy (no,yes) using Breslow's approach for handling of ties.|Proportional hazards models based on prior platinum-based therapy (no, yes). Hazard ratio \< 1 favours respective combination treatment related with a longer PFS than olaparib monotherapy. Here, favours olaparib + adavosertib.|Patient Population BRCAm||1.68|0.48|0.7879
72625955|NCT03330847|144781454|SUPERIORITY||Hazard Ratio (HR)|0.71||||0.3695|TWO_SIDED|90.0|0.38|1.31|||Two-sided log-rank tests|Stratified for prior platinum-based therapy (no,yes) using Breslow's approach for handling of ties.|Proportional hazards models based on prior platinum-based therapy (no, yes). Hazard ratio \< 1 favours respective combination treatment related with a longer PFS than olaparib monotherapy. Here, favours olaparib + ceralasertib.|Patient Population Non BRCAm HRRm||1.31|0.38|0.3695
72625956|NCT03330847|144781454|SUPERIORITY||Hazard Ratio (HR)|0.71||||0.4586|TWO_SIDED|90.0|0.29|1.58|||Two-sided log-rank tests|Stratified for prior platinum-based therapy (no,yes) using Breslow's approach for handling of ties.|Proportional hazards models based on prior platinum-based therapy (no, yes). Hazard ratio \< 1 favours respective combination treatment related with a longer PFS than olaparib monotherapy. Here, favours olaparib + adavosertib.|Patient Population Non BRCAm HRRm||1.58|0.29|0.4586
72625957|NCT03330847|144781454|SUPERIORITY||Hazard Ratio (HR)|0.89||||0.7452|TWO_SIDED|90.0|0.61|1.31|||Two-sided log-rank tests|Stratified for prior platinum-based therapy (no,yes) using Breslow's approach for handling of ties.|Proportional hazards models based on prior platinum-based therapy (no, yes). Hazard ratio \< 1 favours respective combination treatment related with a longer PFS than olaparib monotherapy. Here, favours olaparib + ceralasertib.|Patient Population Non HRRm||1.31|0.61|0.7452
72531779|NCT01270139|144592767|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The sample size was not defined on the basis of an end-point hypothesis, therefore the present FIM study should be considered as hypothesis-generating.|||||<|0.05|TWO_SIDED|||||Overall comparison was assessed by applying the Friedman test, and pairwise comparisons between post-procedure and follow-up (nano vs ferro, nano vs stenting, and ferro vs stenting) were performed by ANOVA.|ANOVA|||The null hypothesis is Nano groups is superior to Ferro group and Stenting control||||<0.05
72531780|NCT01270139|144592768|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The sample size was not defined on the basis of an end-point hypothesis, therefore the present FIM study should be considered as hypothesis-generating.|||||<|0.05|TWO_SIDED|||||Overall comparison was assessed by applying the Friedman test, and pairwise comparisons between post-procedure and follow-up (nano vs ferro, nano vs stenting, and ferro vs stenting) were performed by ANOVA.|ANOVA|||The null hypothesis is Nano group is superior to Ferro group and Stenting control||||<0.05
72531781|NCT01270139|144592769|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The sample size was not defined on the basis of an end-point hypothesis, therefore the present FIM study should be considered as hypothesis-generating.|||||<|0.05|TWO_SIDED|||||Overall comparison was assessed by applying the Friedman test, and pairwise comparisons between post-procedure and follow-up (nano vs ferro, nano vs stenting, and ferro vs stenting) were performed by ANOVA.|ANOVA|||The null hypothesis is Nano groups is superior to Ferro group and Stenting control||||<0.05
72531782|NCT01270139|144592770|OTHER|The Kolmogorov-Smirnov test was used to prove Gaussian distribution allowing for calculation of the mean and standard deviation. Non-Gaussian samples are described by median and range. Discriminant variables are evaluated with the two-sided Fisher's exact test. Differences between three groups were analyzed by means of a repeated-measures oneway ANOVA followed by a Fisher's post hoc test. We used the Cox proportional hazards ratios (HR) and 95% CI for the end points.|||||<|0.05||||||"A p value was calculated for each comparison separately, and indicated as for all comparisons. In case if p value was \>0.05, it was mentioned with a separated info. The threshold for statistical significance was a p value below 0.05."|Kaplan-Meier|||Null hypothesis is Nano group is superior to Ferro group and stenting control.||||<0.05
72531783|NCT01270139|144592771|OTHER|The Kolmogorov-Smirnov test was used to prove Gaussian distribution allowing for calculation of the mean and standard deviation. Non-Gaussian samples are described by median and range. Discriminant variables are evaluated with the two-sided Fisher's exact test. Differences between three groups were analyzed by means of a repeated-measures oneway ANOVA followed by a Fisher's post hoc test. We used the Cox proportional hazards ratios (HR) and 95% CI for the end points.|||||<|0.05||||||"A p value was calculated for each comparison separately, and indicated as for all comparisons. In case if p value was \>0.05, it was mentioned with a separated info. The threshold for statistical significance was a p value below 0.05."|Kaplan-Meier|||Null hypothesis is Nano group is superior to Ferro group and stenting control.||||<0.05
72531784|NCT01270139|144592772|OTHER|The Kolmogorov-Smirnov test was used to prove Gaussian distribution allowing for calculation of the mean and standard deviation. Non-Gaussian samples are described by median and range. Discriminant variables are evaluated with the two-sided Fisher's exact test. Differences between three groups were analyzed by means of a repeated-measures oneway ANOVA followed by a Fisher's post hoc test. We used the Cox proportional hazards ratios (HR) and 95% CI for the end points.|||||<|0.05||||||"A p value was calculated for each comparison separately, and indicated as for all comparisons. In case if p value was \>0.05, it was mentioned with a separated info. The threshold for statistical significance was a p value below 0.05."|Kaplan-Meier|||Null hypothesis is Nano group is superior to Ferro group and stenting control.||||<0.05
72531785|NCT01270139|144592773|OTHER|The Kolmogorov-Smirnov test was used to prove Gaussian distribution allowing for calculation of the mean and standard deviation. Non-Gaussian samples are described by median and range. Discriminant variables are evaluated with the two-sided Fisher's exact test. Differences between three groups were analyzed by means of a repeated-measures oneway ANOVA followed by a Fisher's post hoc test. We used the Cox proportional hazards ratios (HR) and 95% CI for the end points.|||||<|0.05||||||"A p value was calculated for each comparison separately, and indicated as for all comparisons. In case if p value was \>0.05, it was mentioned with a separated info. The threshold for statistical significance was a p value below 0.05."|Kaplan-Meier|||Null hypothesis is Nano group is superior to Ferro group and stenting control.||||<0.05
72625958|NCT03330847|144781454|SUPERIORITY||Hazard Ratio (HR)|0.61||||0.1185|TWO_SIDED|90.0|0.37|1.0|||Two-sided log-rank tests|Stratified for prior platinum-based therapy (no,yes) using Breslow's approach for handling of ties.|Proportional hazards models based on prior platinum-based therapy (no, yes). Hazard ratio \< 1 favours respective combination treatment related with a longer PFS than olaparib monotherapy. Here, favours olaparib + adavosertib.|Patient Population Non HRRm||1.00|0.37|0.1185
72625959|NCT01355627|144781464|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.82|STANDARD_ERROR_OF_MEAN|0.23||0.485|||||||Regression, Logistic|Treatment and pooled centre as covariates.|\< 1 implies a smaller likelihood of a TachoSil treated patient to experience a CSF leak.|||||0.485
72625960|NCT02293551|144781472|SUPERIORITY_OR_OTHER_LEGACY||Geometric Ratio of Least Squares Mean|1.04||||0.2071|TWO_SIDED|90.0|0.988|1.1|||Log Rank|Log (PK) model included treatment, period, and sequence group as fixed effects and participant as a random effect.||||1.10|0.988|0.2071
72625961|NCT02293551|144781472|SUPERIORITY_OR_OTHER_LEGACY||Geometric Ratio of Least Square Means|1.11||||0.0005|TWO_SIDED|90.0|1.06|1.17|||Log Rank|Log (PK) model included treatment, period, and sequence group as fixed effects and participant as a random effect.||||1.17|1.06|0.0005
72625962|NCT02293551|144781472|SUPERIORITY_OR_OTHER_LEGACY||Geometric of Ratio Least Square Means|1.08||||0.0123|TWO_SIDED|90.0|1.03|1.13|||Log Rank|Log (PK) model included treatment, period, and sequence group as fixed effects and participant as a random effect.||||1.13|1.03|0.0123
72625963|NCT02293551|144781472|SUPERIORITY_OR_OTHER_LEGACY||Geometric Ratio of Least Square Means|1.07||||0.0331|TWO_SIDED|90.0|1.02|1.13|||Log Rank|Log (PK) model included treatment, period, and sequence group as fixed effects and participant as a random effect.||||1.13|1.02|0.0331
72625964|NCT02293551|144781472|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.11|||||TWO_SIDED|90.0|1.06|1.16|||||Dose proportionality and the degree of dose proportionality was assessed by fitting the power model versus dose. Estimated ratio of dose-normalized geometric means of PK parameters between the highest and lowest doses assessed dose proportionality.|||1.16|1.06|
72625965|NCT04532749|144781473|SUPERIORITY||Least square (LS) mean difference|-1.2|STANDARD_ERROR_OF_MEAN|1.43|=|0.411|TWO_SIDED|95.0|-4.0|1.64|||Mixed Model Repeated Measures (MMRM)|||||1.64|-4.00|=0.411
72625966|NCT04532749|144781474|SUPERIORITY||LS mean difference|-0.9|STANDARD_ERROR_OF_MEAN|1.27|=|0.473|TWO_SIDED|95.0|-3.41|1.59|||MMRM model|||In accordance with protocol predefined testing sequence, statistical significance of the primary endpoint was required before testing the first secondary endpoint (MADRS-WOSI) and thus, a formal statistical testing was not performed.||1.59|-3.41|=0.473
72531786|NCT01270139|144592774|OTHER|The Kolmogorov-Smirnov test was used to prove Gaussian distribution allowing for calculation of the mean and standard deviation. Non-Gaussian samples are described by median and range. Discriminant variables are evaluated with the two-sided Fisher's exact test. Differences between three groups were analyzed by means of a repeated-measures oneway ANOVA followed by a Fisher's post hoc test. We used the Cox proportional hazards ratios (HR) and 95% CI for the end points.|||||<|0.05||||||"A p value was calculated for each comparison separately, and indicated as for all comparisons. In case if p value was \>0.05, it was mentioned with a separated info. The threshold for statistical significance was a p value below 0.05."|t-test, 2 sided|||Null hypothesis is ex-vivo arm with exposure of nanoparticles is superior to saline control.||||<0.05
72625967|NCT04532749|144781475|SUPERIORITY||LS mean difference|-2.0|STANDARD_ERROR_OF_MEAN|1.45|=|0.167|TWO_SIDED|95.0|-4.87|0.85|||MMRM Model|||In accordance with protocol predefined testing sequence, statistical significance of the primary endpoint was required before testing the second secondary endpoint (PROMIS-SD; Short Form 8a) and thus, a formal statistical testing was not performed.||0.85|-4.87|=0.167
72625968|NCT01230411|144781483|SUPERIORITY||Odds Ratio (OR)|3.12||||0.078|TWO_SIDED|95.0|0.88|11.0|||Regression, Logistic|||||11.0|0.88|0.078
72625969|NCT04756531|144781498|OTHER|Natural log transformed AUClast for PF-07321332 was analyzed using a mixed effect model with sequence, period, and treatment included as fixed effects and subject nested within sequence as a random effect. PF-07321332 250 mg (Tablet), Fasted was the test treatment and PF-07321332 250 mg (Suspension), Fasted was the reference treatment.|Ratio of Adjusted Geometric Means|81.21|||||TWO_SIDED|90.0|69.21|95.28||||||||95.28|69.21|
72625970|NCT04756531|144781499|OTHER|Natural log transformed AUCinf for PF-07321332 was analyzed using a mixed effect model with sequence, period, and treatment included as fixed effects and subject nested within sequence as a random effect. PF-07321332 250 mg (Tablet), Fasted was the test treatment and PF-07321332 250 mg (Suspension), Fasted was the reference treatment.|Ratio of Adjusted Geometric Means|76.06|||||TWO_SIDED|90.0|60.14|96.2||||||||96.20|60.14|
72625971|NCT04756531|144781500|OTHER|Natural log transformed Cmax for PF-07321332 was analyzed using a mixed effect model with sequence, period, and treatment included as fixed effects and subject nested within sequence as a random effect. PF-07321332 250 mg (Tablet), Fasted was the test treatment and PF-07321332 250 mg (Suspension), Fasted was the reference treatment.|Ratio of Adjusted Geometric Means|56.38|||||TWO_SIDED|90.0|43.42|73.19||||||||73.19|43.42|
72531787|NCT00134563|144592790|SUPERIORITY_OR_OTHER||Relative risk reduction (%)|31.5||||0.0005||||||"Step down approach used to adjust for multiplicity:~* H1 tested first~* H2 tested only if the comparison H1 was statistically significant~A priori threshold for statistical significance for both comparisons ≤0.05"|Regression, Poisson||Relative risk reduction with Teriflunomide 14 mg compared to placebo|"Null hypothesis:~* H1: No difference between Teriflunomide 14 mg and placebo~* H2: No difference between Teriflunomide 7 mg and placebo~The study was sized to detect a 25% relative risk reduction with teriflunomide in the 2-year relapse rate at a significance level of 0.050 with a power ≥95% anticipating a potential 20% 2-year dropout rate."||||0.0005
72531788|NCT00134563|144592790|SUPERIORITY_OR_OTHER||Relative Risk Reduction (%)|31.2||||0.0002||||||"Step down approach used to adjust for multiplicity:~* H1 tested first~* H2 tested only if the comparison H1 was statistically significant~A priori threshold for statistical significance for both comparisons ≤0.05"|Regression, Poisson||Relative risk reduction with Teriflunomide 7 mg compared to placebo|||||0.0002
72542632|NCT00373685|144615240|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||Chi-squared|||Week 16||||<0.0001
72625972|NCT04756531|144781533|OTHER|Natural log transformed AUClast for PF-07321332 was analyzed using a mixed effect model with sequence, period, and treatment included as fixed effects and subject nested within sequence as a random effect. PF-07321332 250 mg (Tablet), Fed was the test treatment and PF-07321332 250 mg (Tablet), Fasted was the reference treatment.|Ratio of Adjusted Geometric Means|148.91|||||TWO_SIDED|90.0|126.92|174.72||||||||174.72|126.92|
72625973|NCT04756531|144781534|OTHER|Natural log transformed AUCinf for PF-07321332 was analyzed using a mixed effect model with sequence, period, and treatment included as fixed effects and subject nested within sequence as a random effect. PF-07321332 250 mg (Tablet), Fed was the test treatment and PF-07321332 250 mg (Tablet), Fasted was the reference treatment.|Ratio of Adjusted Geometric Means|146.8|||||TWO_SIDED|90.0|118.8|181.41||||||||181.41|118.80|
72625974|NCT04756531|144781535|OTHER|Natural log transformed Cmax for PF-07321332 was analyzed using a mixed effect model with sequence, period, and treatment included as fixed effects and subject nested within sequence as a random effect. PF-07321332 250 mg (Tablet), Fed was the test treatment and PF-07321332 250 mg (Tablet), Fasted was the reference treatment.|Ratio of Adjusted Geometric Means|244.84|||||TWO_SIDED|90.0|188.58|317.87||||||||317.87|188.58|
72625975|NCT04569084|144781559|SUPERIORITY|||||||0.777|||||||ANCOVA|||||||0.777
72625976|NCT04569084|144781560|SUPERIORITY|||||||0.169|||||||Mixed Model for Repeated Measures (MMRM)|||||||0.169
72531789|NCT00134563|144592791|SUPERIORITY_OR_OTHER||Hazard ratio reduction (%)|29.8||||0.0279||||||"Step down approach:~* H1 tested only if both comparisons on the primary outcome measure were statistically significant~* H2 tested only if the comparison H1 was statistically significant~A priori threshold for statistical significance ≤0.05"|Log Rank|Two-sided Log-rank test stratified by region of enrollment and baseline EDSS stratum|Relative risk reduction with Teriflunomide 14 mg compared to placebo (estimated from a Cox proportional hazard model with treatment arm, region of enrollment and baseline EDSS stratum as covariates)|"Null hypothesis:~* H1: No difference between Teriflunomide 14 mg and placebo~* H2: No difference between Teriflunomide 7 mg and placebo~The study was also sized to detect a 37% hazard rate reduction of an assumed disability progression hazard rate of 0.1783 in the placebo group and 0.1116 in the teriflunomide group by the end of 2 years with a power of 80% anticipating a potential 20% 2-year dropout rate."||||0.0279
72531790|NCT00134563|144592791|SUPERIORITY_OR_OTHER||Hazard ratio reduction (%)|23.7||||0.0835||||||"Step down approach:~* H1 tested only if both comparisons on the primary outcome measure were statistically significant~* H2 tested only if the comparison H1 was statistically significant~A priori threshold for statistical significance ≤0.05"|Log Rank|Two-sided Log-rank test stratified by region of enrollment and baseline EDSS stratum|Relative risk reduction with Teriflunomide 7 mg compared to placebo (estimated from a Cox proportional hazard model with treatment arm, region of enrollment and baseline EDSS stratum as covariates)|||||0.0835
72531791|NCT00134563|144592792|SUPERIORITY_OR_OTHER|||||||0.0003||95.0||||"A priori threshold for statistical significance ≤0.05~No adjustment for multiple comparisons"|t-test, 2 sided|2-sided t-test on baseline adjusted least-square means||Mixed-effect model with repeated measures \[MMRM\] on cubic root transformed total lesion volume data (treatment group, region of enrollment, baseline EDSS stratum, visit, treatment-by-visit interaction, baseline value (cubic root transformed) and baseline-by-visit interaction).||||0.0003
72531792|NCT00134563|144592792|SUPERIORITY_OR_OTHER|||||||0.0317||||||"A priori threshold for statistical significance ≤0.05~No adjustment for multiple comparisons"|t-test, 2 sided|2-sided t-test on baseline adjusted least-square means||Mixed-effect model with repeated measures \[MMRM\] on cubic root transformed total lesion volume data (treatment group, region of enrollment, baseline EDSS stratum, visit, treatment-by-visit interaction, baseline value (cubic root transformed) and baseline-by-visit interaction).||||0.0317
72531793|NCT00134563|144592795|SUPERIORITY_OR_OTHER|||||||0.8271||||||"A priori threshold for statistical significance ≤0.05~No adjustment for multiple comparisons"|t-test, 2 sided|2-sided t-test on baseline adjusted least-square means||||||0.8271
72531794|NCT00134563|144592795|SUPERIORITY_OR_OTHER|||||||0.3861||||||"A priori threshold for statistical significance ≤0.05~No adjustment for multiple comparisons"|t-test, 2 sided|2-sided t-test on baseline adjusted least-square means||||||0.3861
72625977|NCT01400412|144781568|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||Two-sided p-value without adjustment for multiple testing, interpreted at the 5% nominal level of significance|Wilcoxon (Mann-Whitney)|Stratified Wilcoxon rank sum test stratified by age (\<30 and \>=30 years)||The null hypothesis is that there is no difference between the two arms in the percent of total hip BMD change from baseline to week 48||||<0.001
72625978|NCT01444911|144781654|SUPERIORITY_OR_OTHER_LEGACY|||||||0.89|||||||ANOVA|||||||0.89
72625979|NCT00069641|144781662|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|18.96|STANDARD_ERROR_OF_MEAN|6.47||0.0049|TWO_SIDED|95.0|5.99|31.93|||ANCOVA|||p-value for treatment difference based on Analysis of covariance (ANCOVA) model containing treatment, region, baseline participant age, and baseline disease score.||31.93|5.99|0.0049
72625980|NCT03186638|144781665|SUPERIORITY|||||||0.7917|||||||ANCOVA|Adjusted for Baseline values||||||0.7917
72625981|NCT02369536|144781667|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05|||||||ANOVA|||Intention-to-treat-analysis. Differences between basal values in active and control groups and between T1 vsT0 changes in the two groups assessed by ANOVA and Fisher's exact test.||||<0.05
72625982|NCT02369536|144781670|SUPERIORITY||||||<|0.05|||||||ANOVA|||Intention-to-treat-analysis. Differences between basal values in active and control groups and between T1 vsT0 changes in the two groups assessed by ANOVA and Fisher's exact test.||||<0.05
72625983|NCT05067335|144781694|SUPERIORITY||Difference in LSM(Romosozumab - Placebo)|9.37|STANDARD_ERROR_OF_MEAN|0.524|<|0.001|TWO_SIDED|95.0|8.34|10.39|||ANCOVA|||The ANCOVA model was used and included treatment group, Baseline DXA BMD value, machine type (hologic or lunar) at Baseline, age strata group (stratification factor), region, and interaction of Baseline DXA BMD value and machine type at Baseline as independent variables.||10.39|8.34|<0.001
72625984|NCT05067335|144781697|SUPERIORITY||Difference in LSM(Romosozumab - Placebo)|2.86|STANDARD_ERROR_OF_MEAN|0.348|<|0.001|TWO_SIDED|95.0|2.18|3.54|||ANCOVA|||The ANCOVA model was used and included treatment group, Baseline DXA BMD value, machine type (hologic or lunar) at Baseline, age strata group (stratification factor), region, and interaction of Baseline DXA BMD value and machine type at Baseline as independent variables.||3.54|2.18|<0.001
72531795|NCT02452320|144592800|OTHER|||||||0.59|||||||t-test, 2 sided|||||||0.59
72531796|NCT03382639|144592803|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.66||0.426|TWO_SIDED|95.0|-1.4|1.2|||Mixed Models Analysis|||||1.2|-1.4|0.426
72531797|NCT03382639|144592803|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.66||0.725|TWO_SIDED|95.0|-1.5|1.1|||Mixed Models Analysis|||||1.1|-1.5|0.725
72531798|NCT03382639|144592803|SUPERIORITY||LS Mean Difference|0.6|STANDARD_ERROR_OF_MEAN|0.68||0.808|TWO_SIDED|95.0|-0.7|1.9|||Mixed Models Analysis|||||1.9|-0.7|0.808
72542633|NCT00373685|144615240|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0005|TWO_SIDED||||||Chi-squared|||Week 24 or ET||||0.0005
72531799|NCT01072175|144592850|NON_INFERIORITY_OR_EQUIVALENCE|Cmax of dabrafenib was log e transformed and analyzed by a linear mixed effect model with fixed effect for treatment (dabrafenib alone and combined with trametinib) and participant as a random effect. Geometric mean ratio (Day 15/Day 1) and 90% confidence interval were provided.|Geometric Mean Ratio|1.03|||||TWO_SIDED|90.0|0.79|1.34|||||Geometric mean ratio (Day 15 Cmax/Day 1 Cmax) and 90% confidence interval for dabrafenib were calculated.|||1.34|0.79|
72531800|NCT01072175|144592850|NON_INFERIORITY_OR_EQUIVALENCE|Cmax of GSK2285403 was log e transformed and analyzed by a linear mixed effect model with fixed effect for treatment (dabrafenib alone and combined with trametinib) and participant as a random effect. Geometric mean ratio (Day 15/Day 1) and 90% confidence interval were provided.|Geometric Mean Ratio|0.99|||||TWO_SIDED|90.0|0.78|1.25|||||Geometric mean ratio (Day 15 Cmax/Day 1 Cmax) and 90% confidence interval for GSK2285403 were calculated.|||1.25|0.78|
72531801|NCT01072175|144592850|NON_INFERIORITY_OR_EQUIVALENCE|Cmax of GSK2298683 was log e transformed and analyzed by a linear mixed effect model with fixed effect for treatment (dabrafenib alone and combined with trametinib) and participant as a random effect. Geometric mean ratio (Day 15/Day 1) and 90% confidence interval were provided.|Geometric Mean Ratio|1.03|||||TWO_SIDED|90.0|0.84|1.27|||||Geometric mean ratio (Day 15 Cmax/Day 1 Cmax) and 90% confidence interval for GSK2298683 were calculated.|||1.27|0.84|
72531802|NCT01072175|144592850|NON_INFERIORITY_OR_EQUIVALENCE|Cmax of GSK2167542 was log e transformed and analyzed by a linear mixed effect model with fixed effect for treatment (dabrafenib alone and combined with trametinib) and participant as a random effect. Geometric mean ratio (Day 15/Day 1) and 90% confidence interval were provided.|Geometric Mean Ratio|0.98|||||TWO_SIDED|90.0|0.66|1.45|||||Geometric mean ratio (Day 15 Cmax/Day 1 Cmax) and 90% confidence interval for GSK2167542 were calculated.|||1.45|0.66|
72531803|NCT01072175|144592851|NON_INFERIORITY_OR_EQUIVALENCE|AUC(0-t) of dabrafenib was log e transformed and analyzed by a linear mixed effect model with fixed effect for treatment (dabrafenib alone and combined with trametinib) and participant as a random effect. Geometric mean ratio (Day 15/Day 1) and 90% confidence interval were provided.|Geometric Mean Ratio|1.01|||||TWO_SIDED|90.0|0.85|1.19|||||Geometric mean ratio (Day 15 AUC(0-inf)/ Day 1 AUC(0-inf)) and 90% confidence interval for dabrafenib were calculated.|||1.19|0.85|
72531804|NCT01072175|144592851|NON_INFERIORITY_OR_EQUIVALENCE|AUC(0-inf) of dabrafenib was log e transformed and analyzed by a linear mixed effect model with fixed effect for treatment (dabrafenib alone and combined with trametinib) and participant as a random effect. Geometric mean ratio (Day 15/Day 1) and 90% confidence interval were provided.|Geometric Mean Ratio|0.94|||||TWO_SIDED|90.0|0.82|1.08|||||Geometric mean ratio (Day 15 AUC(0-inf)/ Day 1 AUC(0-inf)) and 90% confidence interval for dabrafenib were calculated.|||1.08|0.82|
72531805|NCT01072175|144592851|NON_INFERIORITY_OR_EQUIVALENCE|AUC(0-t) of GSK2285403 was log e transformed and analyzed by a linear mixed effect model with fixed effect for treatment (dabrafenib alone and combined with trametinib) and participant as a random effect. Geometric mean ratio (Day 15/Day 1) and 90% confidence interval were provided.|Geometric Mean Ratio|1.02|||||TWO_SIDED|90.0|0.84|1.25|||||Geometric mean ratio (Day 15 AUC(0-t)/ Day 1 AUC(0-t)) and 90% confidence interval for GSK2285403 were calculated.|||1.25|0.84|
72531806|NCT01072175|144592851|NON_INFERIORITY_OR_EQUIVALENCE|AUC(0-inf) of GSK2285403 was log e transformed and analyzed by a linear mixed effect model with fixed effect for treatment (dabrafenib alone and combined with trametinib) and participant as a random effect. Geometric mean ratio (Day 15/Day 1) and 90% confidence interval were provided.|Geometric Mean Ratio|0.92|||||TWO_SIDED|90.0|0.81|1.03|||||Geometric mean ratio (Day 15 AUC(0-inf)/ Day 1 AUC(0-inf)) and 90% confidence interval for GSK2285403 were calculated.|||1.03|0.81|
72531807|NCT01072175|144592851|NON_INFERIORITY_OR_EQUIVALENCE|AUC(0-t) of GSK2298683 was log e transformed and analyzed by a linear mixed effect model with fixed effect for treatment (dabrafenib alone and combined with trametinib) and participant as a random effect. Geometric mean ratio (Day 15/Day 1) and 90% confidence interval were provided.|Geometric Mean Ratio|1.02|||||TWO_SIDED|90.0|0.81|1.29|||||Geometric mean ratio (Day 15 AUC(0-t)/ Day 1 AUC(0-t)) and 90% confidence interval for GSK2298683 were calculated.|||1.29|0.81|
72572210|NCT02912650|144671814|SUPERIORITY_OR_OTHER||CMH adjusted proportions|7.23||||0.071|TWO_SIDED|95.0|-0.63|15.1|||Cochran-Mantel-Haenszel|||8 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||15.10|-0.63|0.071
72572211|NCT02912650|144671814|SUPERIORITY_OR_OTHER||CMH adjusted proportions|15.12|||<|0.001|TWO_SIDED|95.0|6.55|23.69|||Cochran-Mantel-Haenszel|||8 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||23.69|6.55|<0.001
72531808|NCT01072175|144592851|NON_INFERIORITY_OR_EQUIVALENCE|AUC(0-t) of GSK2167542 was log e transformed and analyzed by a linear mixed effect model with fixed effect for treatment (dabrafenib alone and combined with trametinib) and participant as a random effect. Geometric mean ratio (Day 15/Day 1) and 90% confidence interval were provided.|Geometric Mean Ratio|1.02|||||TWO_SIDED|90.0|0.76|1.37|||||Geometric mean ratio (Day 15 AUC(0-t)/ Day 1 AUC(0-t)) and 90% confidence interval for GSK2167542 were calculated.|||1.37|0.76|
72531809|NCT01072175|144592858|SUPERIORITY_OR_OTHER||Unconditional exact method|-4.0|||||TWO_SIDED|95.0|-23.1|15.9||||||Difference in response rate Arm2 - Arm1||15.9|-23.1|
72531810|NCT01072175|144592858|SUPERIORITY_OR_OTHER||Unconditional exact method|22.0|||||TWO_SIDED|95.0|2.5|40.7||||||Difference in response rate Arm3 - Arm1||40.7|2.5|
72572212|NCT02912650|144671814|SUPERIORITY_OR_OTHER||CMH adjusted proportions|50.74|||<|0.001||95.0|37.39|64.09|||Cochran-Mantel-Haenszel|||8 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||64.09|37.39|<0.001
72572213|NCT02912650|144671814|SUPERIORITY_OR_OTHER||CMH adjusted proportions|43.16|||<|0.001||95.0|29.56|56.75|||Cochran-Mantel-Haenszel|||8 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||56.75|29.56|< 0.001
72572214|NCT02912650|144671814|SUPERIORITY_OR_OTHER||CMH adjusted proportions|7.91||||0.087||95.0|-1.15|16.97|||Cochran-Mantel-Haenszel|||8 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||16.97|-1.15|0.087
72531811|NCT01072175|144592859|SUPERIORITY_OR_OTHER||Unconditional exact method|-6.0|||||TWO_SIDED|95.0|-24.9|14.1||||||Difference in response rate Arm2- Arm1||14.1|-24.9|
72531812|NCT01072175|144592859|SUPERIORITY_OR_OTHER||Unconditional exact method|15.0|||||TWO_SIDED|95.0|-4.9|33.7||||||Difference in response rate Arm3 - Arm1||33.7|-4.9|
72531813|NCT01072175|144592860|SUPERIORITY_OR_OTHER||Response rate|6.0|||||TWO_SIDED|95.0|5.1|26.8||||||||26.8|5.1|
72531814|NCT01072175|144592861|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.58||||0.0048|TWO_SIDED|95.0|0.38|0.87|||Log Rank||HRs were estimated using the Pike estimator.|||0.87|0.38|0.0048
72531815|NCT01072175|144592861|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.44|||<|0.0001|TWO_SIDED|95.0|0.29|0.68|||Log Rank||HRs were estimated using the Pike estimator.|||0.68|0.29|<0.0001
72531816|NCT01072175|144592863|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.73||||0.1667|TWO_SIDED|95.0|0.45|1.18|||Log Rank||HRs were estimated using the Pike estimator.|||1.18|0.45|0.1667
72531817|NCT01072175|144592863|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.54||||0.0119|TWO_SIDED|95.0|0.32|0.9|||Log Rank||HRs were estimated using the Pike estimator.|||0.90|0.32|0.0119
72531818|NCT01072175|144592871|NON_INFERIORITY_OR_EQUIVALENCE|Following loge tranformation, Cmax of dabrafenib after repeat doses from the pooled data in Part B and D were analyzed by a linear model with the following fixed effects as categorical variables: Capsule type (Gelatin or HPMC), BRAF dose (75 or 150 mg BID), Capsule type by BRAF dose interaction, Day (Day 15 or 21), MEK dose (0, 1, 1.5 or 2 mg QD). Geometric mean ratio (HPMC/Gelatin) and the corresponding 90% CI were provided for BRAF dose level 150 mg BID.|Geometric Mean Ratio|1.51|||||TWO_SIDED|90.0|1.1|2.08|||||Geometric mean ratio (HPMC/Gelatin) and the corresponding 90% CI were provided for BRAF dose level 150 mg BID.|||2.08|1.10|
72531819|NCT01072175|144592873|NON_INFERIORITY_OR_EQUIVALENCE|Following loge transformation, AUC(0-tau) of dabrafenib was analyzed by a linear mixed effect model with dosing chort and day as fixed effects and subject as random effect. Based on the model, geometric mean ratio (Day 21 Dabrafenib 150 mg BID+Trametinib 2 mg QD/Day 21 Dabrafenib 150 mg BID alone) and the corresponding 90% confidence interval were provided.|Geometric Mean Ratio|1.23|||||TWO_SIDED|90.0|0.89|1.69|||||Geometric mean ratio (Day 21 Dabrafenib 150 mg BID+Trametinib 2 mg QD/Day 21 Dabrafenib 150 mg BID alone) and the corresponding 90% confidence interval were provided.|||1.69|0.89|
72531820|NCT01072175|144592873|NON_INFERIORITY_OR_EQUIVALENCE|Following loge tranformation, AUC(0-tau) of dabrafenib after repeat doses from the pooled data in Part B and D were analyzed by a linear model with the following fixed effects as categorical variables: Capsule type (Gelatin or HPMC), BRAF dose (75 or 150 mg BID), Capsule type by BRAF dose interaction, Day (Day 15 or 21), MEK dose (0, 1, 1.5, 2 or 2 mg QD). Geometric mean ratio (HPMC/Gelatin) and the corresponding 90% CI were then provided for BRAF dose level 150 mg BID.|Geometric Mean Ratio|1.1|||||TWO_SIDED|90.0|0.84|1.44|||||Geometric mean ratio (HPMC/Gelatin) and the corresponding 90% CI were provided for BRAF dose level 150 mg BID.|||1.44|0.84|
72531821|NCT00218439|144592910|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||Mixed Models Analysis|||||||<0.001
72531822|NCT00218439|144592911|SUPERIORITY_OR_OTHER_LEGACY|||||||0.006|||||||Mixed Models Analysis|||||||0.006
72531823|NCT00218439|144592912|SUPERIORITY_OR_OTHER_LEGACY|||||||0.56|||||||Mixed Models Analysis|||||||0.56
72531824|NCT00218439|144592913|SUPERIORITY_OR_OTHER_LEGACY|||||||0.33|||||||Mixed Models Analysis|||||||0.33
72531825|NCT00218439|144592914|SUPERIORITY_OR_OTHER_LEGACY|||||||0.82|||||||Mixed Models Analysis|||||||0.82
72531826|NCT01474291|144592960|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.56||||0.023|TWO_SIDED|95.0|1.06|2.3|||Wald Chi-square|Wald Chi-square Test for Type 3 generalized estimating equation (GEE) Analysis.||"Influence of baseline factor Patient's Age (\>=65) upon physician's decision to initiate tocilizumab monotherapy (multivariate analysis)."||2.30|1.06|0.0230
72531827|NCT01474291|144592960|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.74|||<|0.0001|TWO_SIDED|95.0|3.92|8.43|||Wald Chi-square|Wald Chi-square Test for Type 3 GEE Analysis.||"Influence of baseline factor No methotrexate (MTX) sequences within the two last years upon physician's decision to initiate tocilizumab monotherapy (multivariate analysis)."||8.43|3.92|<0.0001
72531828|NCT01474291|144592960|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.03||||0.0212|TWO_SIDED|95.0|1.11|3.7|||Wald Chi-square|Wald Chi-square Test for Type 3 GEE Analysis.||"Influence of baseline factor Past history of severe infectious disease upon physician's decision to initiate tocilizumab monotherapy (multivariate analysis)."||3.70|1.11|0.0212
72531829|NCT01474291|144592960|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.22||||0.0076|TWO_SIDED|95.0|1.05|1.41|||Wald Chi-square|Wald Chi-square Test for Type 3 GEE Analysis.||"Influence of baseline factor Higher Disease Activity Score Based on 28-joint Count and Erythrocyte Sedimentation Rate (DAS28-ESR) (unit=1) on physician decision to initiate tocilizumab monotherapy; DAS28-ESR was calculated from the number of swollen joints and tender joints using 28-joint count, ESR (millimeters per hour \[mm/hour\]) and patient's global assessment of disease activity; scores range from 0 to 10; higher scores correspond to greater disease activity (multivariate analysis)."||1.41|1.05|0.0076
72531830|NCT00148109|144592985|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Fisher Exact|||Estimate a 4 month progression-free survival rate for each group.||||<0.05
72531831|NCT01098266|144592988|SUPERIORITY||Hazard Ratio (HR)|0.94||||0.58|TWO_SIDED|95.0|0.75|1.18||The log-rank test (unstratified) was used to compare the two treatment arms. In addition, a stratified version of the log-rank test was performed with the stratification factors used for randomization.|Log Rank|Cox regression analyses (unstratified and stratified) were performed to assess the influence of baseline covariates in an exploratory manner.||Study with one control per experimental patient, an accrual interval of 24 months, and an additional FU after the accrual interval of 12 months.If the true HR of experimental relative to control patients was 0.726, then 195 experimental patients and 195 control patients were required to be able to reject the null hypothesis that the experimental and control survival curves were equal with probability (power)0.80 Type I error probability associated with this test of this null hypothesis was 0.05||1.18|0.75|0.58
72531832|NCT01098266|144592989|SUPERIORITY||Hazard Ratio (HR)|0.95||||0.65|TWO_SIDED|95.0|0.78|1.17|||Log Rank|Cox regression analyses (unstratified and stratified) was performed to assess the influence of baseline covariates in an exploratory manner.||The log-rank test (unstratified and stratified) was used at an alpha level of 5% to test for differences in PFS between the two treatment arms. Kaplan-Meier curves and estimates were provided.||1.17|0.78|0.65
72542634|NCT00373685|144615240|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||Chi-squared|||Week 24/LOCF||||<0.0001
72542635|NCT00373685|144615241|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6562|TWO_SIDED||||||Chi-squared|||Baseline||||0.6562
72625985|NCT05067335|144781698|SUPERIORITY||Difference in LSM(Romosozumab - Placebo)|3.48|STANDARD_ERROR_OF_MEAN|0.458|<|0.001|TWO_SIDED|95.0|2.58|4.38|||ANCOVA|||The ANCOVA model was used and included treatment group, Baseline DXA BMD value, machine type (hologic or lunar) at Baseline, age strata group (stratification factor), region, and interaction of Baseline DXA BMD value and machine type at Baseline as independent variables.||4.38|2.58|<0.001
72531833|NCT01098266|144592990|SUPERIORITY||Odds Ratio (OR)|1.13||||0.62|TWO_SIDED|95.0|0.76|1.68|||Fisher Exact||Logistic regression analyses were performed to assess the influence of baseline covariates in an exploratory manner|Difference in DCR between the two treatment arms were tested using a chi-squared test with 95% confidence intervals calculated in each treatment arm.||1.68|0.76|0.62
72531834|NCT01098266|144592993|OTHER|Two-sided log-rank test was used to compare time to symptomatic progression between treatment arms. Median and 95% confidence limits for the time to symptomatic progression were estimated using Kaplan-Meier survival methodology. Estimates of the treatment effect were expressed as hazard ratio including 95% confidence intervals.|Hazard Ratio (HR)|0.92||||0.5806|TWO_SIDED|95.0|0.68|1.26|||Log Rank|||QoL assessment was performed by using a questionnaire according to LCSS, which consists of nine 100-mm visual analog scales, with scores reported from 0 to 100(the best score). The LCSS subscore is the average symptom burden index computed as the mean score for all 6 major symptoms. Symptomatic progression was defined as a worsening in the average symptom burden index by 25%.||1.26|0.68|0.5806
72531835|NCT01733758|144593011|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.55|||||TWO_SIDED|95.0|-1.72|-1.39|||ANCOVA|||||-1.39|-1.72|
72531836|NCT01733758|144593011|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.35|||||TWO_SIDED|95.0|-1.51|-1.18|||ANCOVA|||||-1.18|-1.51|
72531837|NCT01733758|144593011|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||The first test in a sequential testing procedure starting with albiglutide 50 mg versus placebo, and if significant at 0.05 level, followed by albiglutide 30 mg versus placebo.|t-test, 2 sided|The p-value is from a 2-sided t-test to test whether the difference of least squares (LS) means (albiglutide 50 mg - placebo) is equal to zero.||||||<0.0001
72531838|NCT01733758|144593011|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||The second test in a sequential testing procedure starting with albiglutide 50 mg versus placebo, and if significant at 0.05 level, followed by albiglutide 30 mg versus placebo.|t-test, 2 sided|The p-value is from a 2-sided t-test to test whether the difference of LS means (albiglutide 30 mg - placebo) is equal to zero.||||||<0.0001
72531839|NCT01111058|144593022|SUPERIORITY||Difference in survival proportions|0.0022||||0.9|TWO_SIDED|95.0|-0.33|0.33|||Comparison of Kaplan-Meier estimates|Used Greenwood standard errors||||0.33|-0.33|0.90
72531840|NCT01111058|144593022|SUPERIORITY|||||||0.54|||||||Log Rank|||||||0.54
72531841|NCT01111058|144593023|SUPERIORITY|||||||0.086|||||||Fisher Exact|||||||0.086
72531842|NCT02790476|144593033|SUPERIORITY||Mean Difference (Final Values)|-27.8|||<|0.05|TWO_SIDED|95.0|-38.2|-17.63||The threshold for statistical significance was p=0.05.|Mixed Models Analysis||This measure is a difference-in-difference, calculated by subtracting the pre- and post-intervention difference in mean MME in the letter (288.36-347.65 = -59.29) and control (318.60-350.09 = -31.49) arms, resulting in a difference of -27.80.|1-3 months post intervention||-17.63|-38.20|<0.05
72531843|NCT02790476|144593033|SUPERIORITY||Mean Difference (Final Values)|-12.42|||<|0.01|TWO_SIDED|95.0|-18.4|-6.55||The threshold for statistical significance was p=0.05.|Mixed Models Analysis||This measure is a difference-in-difference, calculated by subtracting the pre- and post-intervention difference in mean MME in the letter (167.83-347.65 = -179.83) and control (182.67-350.09 = -167.41) arms, resulting in a difference of -12.42.|||-6.55|-18.40|<0.01
72542636|NCT00373685|144615241|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||Chi-squared|||Week 8||||<0.0001
72542637|NCT00373685|144615241|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||Chi-squared|||Week 16||||<0.0001
72542638|NCT00373685|144615241|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0245|TWO_SIDED||||||Chi-squared|||Week 24 or ET||||0.0245
72542639|NCT00373685|144615241|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0074|TWO_SIDED||||||Chi-squared|||Week 24/LOCF||||0.0074
72542640|NCT00373685|144615242|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4074|TWO_SIDED||||||Chi-squared|||Baseline||||0.4074
72542641|NCT00373685|144615242|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||Chi-squared|||Week 8||||<0.0001
72542642|NCT00373685|144615242|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||Chi-squared|||Week 16||||<0.0001
72542643|NCT00373685|144615242|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0127|TWO_SIDED||||||Chi-squared|||Week 24 or ET||||0.0127
72542644|NCT00373685|144615242|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0019|TWO_SIDED||||||Chi-squared|||Week 24/LOCF||||0.0019
72542645|NCT00373685|144615243|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2699|TWO_SIDED||||||Chi-squared|||Baseline||||0.2699
72542646|NCT00373685|144615243|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||Chi-squared|||Week 8||||<0.0001
72542647|NCT00373685|144615243|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||Chi-squared|||Week 16||||<0.0001
72542648|NCT00373685|144615243|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0027|TWO_SIDED||||||Chi-squared|||Week 24 or ET||||0.0027
72542649|NCT00373685|144615243|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0001|TWO_SIDED||||||Chi-squared|||Week 24/LOCF||||0.0001
72542650|NCT01864525|144615271|SUPERIORITY|||||||0.0216||||||Statistical results for Magnitude of acoustic amplitude tremor. A priori significance threshold was set at P\<0.05 for each of the two hypothesis-driven acoustic variables.|Mixed Models Analysis|This statistical test did not use the baseline scores as a covariate when comparing post-test scores between placebo and octanoic acid conditions.||Separate measures for magnitude of amplitude tremor and magnitude of frequency tremor were analyzed as these variables can respond differently to treatment and may be differentially affected in essential voice tremor. Statistical modeling tested for post-treatment drug differences, with testing session as a repeated factor. Models were run with and without inclusion of baseline averages as a covariate per recommendations for cross-over treatment studies (Fleiss, Wallenstein \& Rosenfeld, 1985).||||0.0216
72531844|NCT02790476|144593034|SUPERIORITY||Mean Difference (Final Values)|-0.35||||0.224|TWO_SIDED|95.0|-0.92|0.22||The threshold for statistical significance was p=0.05.|Mixed Models Analysis||This measure is a difference-in-difference, calculated by subtracting the pre- and post-intervention difference in mean MME in the letter (3.45-3.74 = -0.29) and control (3.45-4.59= -0.64) arms, resulting in a difference of -0.35.|Change in mean number of =\> 50 MME prescriptions pre- to 1-3 months post-intervention||0.22|-0.92|0.224
72531845|NCT02790476|144593034|SUPERIORITY||Mean Difference (Final Values)|-0.7|||<|0.001|TWO_SIDED|95.0|-1.08|-0.33||The threshold for statistical significance was p=0.05.|Mixed Models Analysis||This measure is a difference-in-difference, calculated by subtracting the pre- and post-intervention difference in mean MME in the letter (3.00-3.74 = -0.74) and control (3.15-4.59= -1.44) arms, resulting in a difference of -0.70.|Change in mean number of =\> 50 MME prescriptions pre- to 4-12 months post-intervention||-0.33|-1.08|<0.001
72531846|NCT02790476|144593034|SUPERIORITY||Mean Difference (Final Values)|-0.21||||0.279|TWO_SIDED|95.0|-0.59|0.17||The threshold for statistical significance was p=0.05.|Mixed Models Analysis||This measure is a difference-in-difference, calculated by subtracting the pre- and post-intervention difference in mean MME in the letter (2.00-2.14 = -0.14) and control (2.20-2.55= -0.35) arms, resulting in a difference of -0.21.|Change in mean number of \> 90 MME prescriptions pre- to 1-3 months post-intervention||0.17|-0.59|0.279
72531847|NCT02790476|144593034|SUPERIORITY||Mean Difference (Final Values)|-0.38|||<|0.01|TWO_SIDED|95.0|-0.63|-0.12||The threshold for statistical significance was p=0.05.|Mixed Models Analysis||This measure is a difference-in-difference, calculated by subtracting the pre- and post-intervention difference in mean MME in the letter (1.71-2.14 = -0.43) and control (1.74-2.55= -0.81) arms, resulting in a difference of -0.38.|Change in mean number of \> 90 MME prescriptions pre- to 4-12 months post-intervention||-0.12|-0.63|<0.01
72531848|NCT02790476|144593035|SUPERIORITY||Mean Difference (Final Values)|-1.6|||<|0.05|TWO_SIDED|95.0|-3.2|-0.1||The threshold for statistical significance was p=0.05.|Mixed Models Analysis|Pre-intervention values were trimmed at 95% with bootstrapped means and confidence intervals.|This measure is a difference-in-difference, calculated by subtracting the pre- and post-intervention difference in mean DME in the letter (72.3-76 = -3.7) and control (82-82.9 = -0.9) arms, resulting in a difference of -1.6.|||-0.1|-3.2|<0.05
72531849|NCT02790476|144593037|SUPERIORITY||Mean Difference (Final Values)|0.03||||0.823|TWO_SIDED|95.0|-0.23|0.29||The threshold for statistical significance was p=0.05.|Mixed Models Analysis||This measure is a difference-in-difference, calculated by subtracting the pre- and post-intervention difference in mean MME in the letter (2.44-3.72 = -1.28) and control (2.26-3.51= -1.25) arms, resulting in a difference of 0.03.|Change in mean number of new patients pre- to 1-3 months post-intervention||0.29|-0.23|0.823
72531850|NCT02790476|144593037|SUPERIORITY||Mean Difference (Final Values)|-0.03||||0.692|TWO_SIDED|95.0|-0.2|0.14||The threshold for statistical significance is p=0.05.|Mixed Models Analysis||This measure is a difference-in-difference, calculated by subtracting the pre- and post-intervention difference in mean MME in the letter (2.08-3.72 = -1.64) and control (1.84-3.51= -1.67) arms, resulting in a difference of -0.03.|Change in mean number of new patients pre- to 4-12 months post-intervention||0.14|-0.20|0.692
72531851|NCT00538434|144593082|SUPERIORITY_OR_OTHER||Adjusted mean difference|-52.78|STANDARD_ERROR_OF_MEAN|11.4|<|0.0001|TWO_SIDED|95.0|-75.24|-30.32|||ANCOVA|adjustment for stratification factor and for variable at Baseline||||-30.32|-75.24|< 0.0001
72531852|NCT00538434|144593082|SUPERIORITY_OR_OTHER||Adjusted mean difference|-73.03|STANDARD_ERROR_OF_MEAN|11.29|<|0.0001|TWO_SIDED|95.0|-95.28|-50.78|||ANCOVA|adjustment for stratification factor and for variable at Baseline||||-50.78|-95.28|< 0.0001
72531853|NCT00538434|144593082|SUPERIORITY_OR_OTHER||Adjusted mean difference|-64.69|STANDARD_ERROR_OF_MEAN|11.28|<|0.0001|TWO_SIDED|95.0|-86.93|-42.45|||ANCOVA|adjustment for stratification factor and for variable at Baseline||||-42.45|-86.93|< 0.0001
72531854|NCT00538434|144593083|SUPERIORITY_OR_OTHER|||||||0.0313|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.0313
72531855|NCT00538434|144593083|SUPERIORITY_OR_OTHER|||||||0.5793|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.5793
72531856|NCT00538434|144593083|SUPERIORITY_OR_OTHER|||||||0.4905|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.4905
72531857|NCT00538434|144593084|SUPERIORITY_OR_OTHER|||||||0.0062|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.0062
72531858|NCT00538434|144593084|SUPERIORITY_OR_OTHER|||||||0.0943|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.0943
72408004|NCT03238911|144324423|SUPERIORITY||Mean Difference (Final Values)|1.35|||<|0.0001|TWO_SIDED|95.0|1.1|1.6|||Mixed model for repeated measures|||"Day 14~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||1.60|1.10|<0.0001
72531859|NCT00538434|144593084|SUPERIORITY_OR_OTHER|||||||0.2955|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.2955
72531860|NCT00538434|144593085|SUPERIORITY_OR_OTHER||Adjusted mean difference|-4.75|STANDARD_ERROR_OF_MEAN|6.48||0.4644|TWO_SIDED|95.0|-17.53|8.03||Analyzed using analysis of covariance with adjustment for stratification factor and for variable at baseline.|ANCOVA||Comparison of least square means provides the difference (of individual change scores) between each reslizumab dose group and placebo.|Physical Summary Score||8.03|-17.53|0.4644
72531861|NCT00538434|144593085|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.47|STANDARD_ERROR_OF_MEAN|6.44||0.8196|TWO_SIDED|95.0|-14.17|11.23||Analyzed using analysis of covariance with adjustment for stratification factor and for variable at baseline.|ANCOVA||Comparison of least square means provides the difference (of individual change scores) between each reslizumab dose group and placebo.|Physical Summary Score||11.23|-14.17|0.8196
72531862|NCT00538434|144593085|SUPERIORITY_OR_OTHER||Adjusted mean difference|1.36|STANDARD_ERROR_OF_MEAN|6.36||0.8306|TWO_SIDED|95.0|-11.19|13.91||Analyzed using analysis of covariance with adjustment for stratification factor and for variable at baseline.|ANCOVA||Comparison of least square means provides the difference (of individual change scores) between each reslizumab dose group and placebo.|Physical Summary Score||13.91|-11.19|0.8306
72572215|NCT02912650|144671814|SUPERIORITY_OR_OTHER||CMH adjusted proportions|58.12|||<|0.001||95.0|45.24|71.0|||Cochran-Mantel-Haenszel|||9 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores||71.00|45.24|< 0.001
72531863|NCT00538434|144593085|SUPERIORITY_OR_OTHER||Adjusted mean difference|-6.38|STANDARD_ERROR_OF_MEAN|4.37||0.1459|TWO_SIDED|95.0|-15.01|2.24||Analyzed using analysis of covariance with adjustment for stratification factor and for variable at baseline.|ANCOVA||Comparison of least square means provides the difference (of individual change scores) between each reslizumab dose group and placebo.|Psychosocial Summary Score||2.24|-15.01|0.1459
72625986|NCT00261833|144781702|SUPERIORITY_OR_OTHER||Difference in lung density(adjusted P15)|0.618||||0.029|TWO_SIDED|95.0|-0.024|1.261||A 1-sided P-value less than 0.025 and a positive estimate of the treatment difference Zemaira minus placebo (ie, the lower bound of the 95% confidence interval \[CI\] being greater than zero) will indicate superiority of Zemaira compared with Placebo.|95% confidence interval||A mixed model was used to estimate the 95% CI for the difference (Zemaira® - placebo) in annual lung density decline.|Analysis of the annual rate of change in lung density (TLC+FRC combined) was a linear mixed model with country, inspiration state, time since baseline treatment, and treatment-by-time interaction as fixed effects and participant and participant-by-time interaction as random coefficients at a 1-sided significance level of 0.025.||1.261|-0.024|0.029
72625987|NCT00261833|144781702|SUPERIORITY_OR_OTHER||Difference in lung density(adjusted P15)|0.74||||0.017|TWO_SIDED|95.0|0.059|1.42||A 1-sided P-value less than 0.025 and a positive estimate of the treatment difference Zemaira® minus placebo (ie, the lower bound of the 95% CI being greater than zero) will indicate superiority of Zemaira® compared with Placebo.|95% confidence interval||A mixed model was used to estimate the 95% CI for the difference (Zemaira® - placebo) in annual lung density decline.|Analysis of the annual rate of change in lung density (TLC) was a linear mixed model with country, time since baseline treatment, and treatment-by-time interaction as fixed effects and participant and participant-by-time interaction as random coefficients at a 1-sided significance level of 0.025.||1.420|0.059|0.017
72625988|NCT00261833|144781702|SUPERIORITY_OR_OTHER||Difference in lung density(adjusted P15)|0.478||||0.09|TWO_SIDED|95.0|-0.223|1.18||A 1-sided P-value less than 0.025 and a positive estimate of the treatment difference Zemaira® minus placebo (ie, the lower bound of the 95% CI being greater than zero) will indicate superiority of Zemaira® compared with Placebo.|95% confidence interval||A mixed model was used to estimate the 95% CI for the difference (Zemaira® - placebo) in annual lung density decline.|Analysis of the annual rate of change in lung density (FRC) was a linear mixed model with country, time since baseline treatment, and treatment-by-time interaction as fixed effects and participant and participant-by-time interaction as random coefficients at a 1-sided significance level of 0.025.||1.180|-0.223|0.090
72625989|NCT00261833|144781706|SUPERIORITY_OR_OTHER||Difference in lung density(adjusted P15)|1.04||||0.058|TWO_SIDED|95.0|-0.26|2.34||A 1-sided P-value less than 0.025 and a positive estimate of the treatment difference Zemaira® minus placebo (ie, the lower bound of the 95% CI being greater than zero) will indicate superiority of Zemaira® compared with Placebo.|95% confidence interval||A mixed model ANCOVA was used to estimate the 95% CI for the difference (Zemaira® - placebo) in the change in lung density.|Analysis of the change in lung density (TLC+FRC combined) from baseline to Month 24 was a mixed effects analysis of covariance (ANCOVA) model with country, treatment, and baseline lung density as fixed effects and inspiration state as a repeated random effect at a 1-sided significance level of 0.025.||2.34|-0.26|0.058
72531864|NCT00538434|144593085|SUPERIORITY_OR_OTHER||Adjusted mean difference|-3.41|STANDARD_ERROR_OF_MEAN|4.38||0.4375|TWO_SIDED|95.0|-12.05|5.23||Analyzed using analysis of covariance with adjustment for stratification factor and for variable at baseline.|ANCOVA||Comparison of least square means provides the difference (of individual change scores) between each reslizumab dose group and placebo.|Psychosocial Summary Score||5.23|-12.05|0.4375
72625990|NCT00261833|144781706|SUPERIORITY_OR_OTHER||Difference in lung density(adjusted P15)|1.32||||0.028|TWO_SIDED|95.0|-0.03|2.67||A 1-sided P-value less than 0.025 and a positive estimate of the treatment difference Zemaira® minus placebo (i.e., the lower bound of the 95% CI being greater than zero) will indicate superiority of Zemaira® compared with Placebo.|95% confidence interval||A mixed model ANCOVA was used to estimate the 95% CI for the difference (Zemaira® - placebo) in the change in lung density.|Analysis of the change in lung density (TLC) from baseline to Month 24 was a mixed effects ANCOVA model with country, treatment, and baseline lung density as fixed effects at a 1-sided significance level of 0.025.||2.67|-0.03|0.028
72531865|NCT00538434|144593085|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.43|STANDARD_ERROR_OF_MEAN|4.35||0.9217|TWO_SIDED|95.0|-9.0|8.15||Analyzed using analysis of covariance with adjustment for stratification factor and for variable at baseline.|ANCOVA||Comparison of least square means provides the difference (of individual change scores) between each reslizumab dose group and placebo.|Psychosocial Summary Score||8.15|-9.00|0.9217
72531866|NCT00538434|144593085|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.57|STANDARD_ERROR_OF_MEAN|7.82||0.8412|TWO_SIDED|95.0|-16.98|13.85||Analyzed using analysis of covariance with adjustment for stratification factor and for variable at baseline.|ANCOVA||Comparison of least square means provides the difference (of individual change scores) between each reslizumab dose group and placebo.|Global Health Score||13.85|-16.98|0.8412
72531867|NCT00538434|144593085|SUPERIORITY_OR_OTHER||Adjusted mean difference|-5.54|STANDARD_ERROR_OF_MEAN|7.81||0.4794|TWO_SIDED|95.0|-20.94|9.87||Analyzed using analysis of covariance with adjustment for stratification factor and for variable at baseline.|ANCOVA||Comparison of least square means provides the difference (of individual change scores) between each reslizumab dose group and placebo.|Global Health Score||9.87|-20.94|0.4794
72531868|NCT00538434|144593085|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.06|STANDARD_ERROR_OF_MEAN|7.66||0.8906|TWO_SIDED|95.0|-16.16|14.06||Analyzed using analysis of covariance with adjustment for stratification factor and for variable at baseline.|ANCOVA||Comparison of least square means provides the difference (of individual change scores) between each reslizumab dose group and placebo.|Global Health Score||14.06|-16.16|0.8906
72531869|NCT04594213|144593086|SUPERIORITY||||||<|0.0001|||||||Mantel Haenszel|||||||<0.0001
72531870|NCT04594213|144593087|SUPERIORITY||||||<|0.0001|||||||Mantel Haenszel|||||||<0.0001
72531871|NCT04594213|144593088|SUPERIORITY||||||<|0.0001|||||||Mantel Haenszel|||||||<0.0001
72531872|NCT04594213|144593089|SUPERIORITY||||||<|0.0001|||||||Mantel Haenszel|||||||<0.0001
72572216|NCT02912650|144671814|SUPERIORITY_OR_OTHER||CMH adjusted proportions|7.23||||0.071||95.0|-0.63|15.1|||Cochran-Mantel-Haenszel|||9 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||15.10|-0.63|0.071
72531873|NCT04594213|144593090|SUPERIORITY||||||<|0.0001|||||||Mantel Haenszel|||||||<0.0001
72531874|NCT04594213|144593091|SUPERIORITY||||||<|0.0001|||||||Mantel Haenszel|||||||<0.0001
72572217|NCT02912650|144671814|SUPERIORITY_OR_OTHER||CMH adjusted proportions|15.12|||<|0.001||95.0|6.55|23.69|||Cochran-Mantel-Haenszel|||9 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||23.69|6.55|< 0.001
72531875|NCT04594213|144593092|SUPERIORITY||||||<|0.0001|||||||Mantel Haenszel|||||||<0.0001
72531876|NCT04594213|144593093|SUPERIORITY||||||<|0.0001|||||||Mantel Haenszel|||||||<0.0001
72531877|NCT04594213|144593094|SUPERIORITY||||||<|0.0001|||||||Mantel Haenszel|||||||<0.0001
72531878|NCT04594213|144593095|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
72531879|NCT04594213|144593096|SUPERIORITY||||||<|0.0001|||||||Mantel Haenszel|||||||<0.0001
72531880|NCT04594213|144593096|SUPERIORITY||||||<|0.0001|||||||Mantel Haenszel|||||||<0.0001
72531881|NCT04594213|144593097|SUPERIORITY||||||<|0.0001|||||||Mantel Haenszel|||||||<0.0001
72531882|NCT04594213|144593097|SUPERIORITY||||||<|0.0001|||||||Mantel Haenszel|||||||<0.0001
72531883|NCT04594213|144593098|SUPERIORITY||||||<|0.0001|||||||Mantel Haenszel|||||||<0.0001
72531884|NCT04594213|144593099|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
72531885|NCT04594213|144593099|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
72531886|NCT03814499|144593106|OTHER||Coefficient|-2.3|||<|0.01|TWO_SIDED||||||Regression, Linear|||||||<0.01
72531887|NCT03814499|144593107|OTHER||Coefficient|-3.8|||<|0.01|TWO_SIDED||||||Regression, Linear|||||||<0.01
72572218|NCT02912650|144671814|SUPERIORITY_OR_OTHER||CMH adjusted proportions|50.74|||<|0.001|TWO_SIDED|95.0|37.39|64.09|||Cochran-Mantel-Haenszel|||9 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores||64.09|37.39|<0.001
72572219|NCT02912650|144671814|SUPERIORITY_OR_OTHER||CMH adjusted proportions|43.16|||<|0.001|TWO_SIDED|95.0|29.56|56.75|||Cochran-Mantel-Haenszel|||9 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||56.75|29.56|<0.001
72572220|NCT02912650|144671814|SUPERIORITY_OR_OTHER||CMH adjusted proportions|7.91||||0.087||95.0|-1.15|16.97|||Cochran-Mantel-Haenszel|||9 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores||16.97|-1.15|0.087
72531888|NCT03814499|144593108|OTHER||Coefficient|369.9||||0.3269|TWO_SIDED||||||Regression, Linear|||||||0.3269
72531889|NCT03814499|144593109|OTHER||Coefficient|365.4||||0.4265|TWO_SIDED||||||Regression, Linear|||||||0.4265
72531890|NCT03814499|144593110|OTHER||Coefficient|264.3||||0.4782|TWO_SIDED||||||Regression, Linear|||||||0.4782
72531891|NCT03814499|144593111|OTHER||Coefficient|730.2||||0.2716|TWO_SIDED||||||Regression, Linear|||||||0.2716
72531892|NCT03814499|144593112|OTHER||Coefficient|-0.6||||0.4178|TWO_SIDED||||||Regression, Linear|||||||0.4178
72531893|NCT03814499|144593113|OTHER||Coefficient|-1.5||||0.2677|TWO_SIDED||||||Regression, Linear|||||||0.2677
72531894|NCT03814499|144593114|OTHER||Coefficient|-467.0||||0.3364|TWO_SIDED||||||Regression, Linear|||||||0.3364
72531895|NCT03814499|144593115|OTHER||Coefficient|-908.0||||0.1124|TWO_SIDED||||||Regression, Linear|||||||0.1124
72531896|NCT03814499|144593116|OTHER||Coefficient|479.2||||0.2649|TWO_SIDED||||||Regression, Linear|||||||0.2649
72531897|NCT03814499|144593117|OTHER||Coefficient|1114.3||||0.216|TWO_SIDED||||||Regression, Linear|||||||0.216
72531898|NCT03814499|144593118|OTHER||Coefficient|0.1||||0.9032|TWO_SIDED||||||Regression, Linear|||||||0.9032
72531899|NCT03814499|144593119|OTHER||Coefficient|-0.4||||0.7889|TWO_SIDED||||||Regression, Linear|||||||0.7889
72531900|NCT03814499|144593120|OTHER||Coefficient|7.0||||0.0242|TWO_SIDED||||||Regression, Linear|||||||0.0242
72531901|NCT03814499|144593121|OTHER||Coefficient|1.5||||0.5092|TWO_SIDED||||||Regression, Linear|||||||0.5092
72531902|NCT03814499|144593122|OTHER||Coefficient|-47.1||||0.3634|TWO_SIDED||||||Regression, Linear|||||||0.3634
72531903|NCT03814499|144593123|OTHER||Coefficient|-204.7||||0.0677|TWO_SIDED||||||Regression, Linear|||||||0.0677
72531904|NCT03814499|144593124|OTHER||Coefficient|-235.8||||0.156|TWO_SIDED||||||Regression, Linear|||||||0.156
72531905|NCT03814499|144593125|OTHER||Coefficient|-102.0||||0.3148|TWO_SIDED||||||Regression, Linear|||||||0.3148
72531906|NCT03814499|144593126|OTHER||Coefficient|-0.1||||0.9349|TWO_SIDED||||||Regression, Linear|||||||0.9349
72531907|NCT03814499|144593127|OTHER||Coefficient|-0.6||||0.7196|TWO_SIDED||||||Regression, Linear|||||||0.7196
72531908|NCT03814499|144593128|OTHER||Coefficient|4.7||||0.0542|TWO_SIDED||||||Regression, Linear|||||||0.0542
72531909|NCT03814499|144593129|OTHER||Coefficient|2.6||||0.4224|TWO_SIDED||||||Regression, Linear|||||||0.4224
72531910|NCT03814499|144593130|OTHER||Coeffiient|-118.9||||0.1247|TWO_SIDED||||||Regression, Linear|||||||0.1247
72531911|NCT03814499|144593131|OTHER||Coefficient|-135.2||||0.1461|TWO_SIDED||||||Regression, Linear|||||||0.1461
72531912|NCT03814499|144593132|OTHER||Coefficient|-154.2||||0.0699|TWO_SIDED||||||Regression, Linear|||||||0.0699
72531913|NCT03814499|144593133|OTHER||Coefficient|-164.6||||0.0901|TWO_SIDED||||||Regression, Linear|||||||0.0901
72531914|NCT01589185|144593135|SUPERIORITY|||||||0.3962||||||\< 0.1 is considered borderline significant|Fisher Exact|||The number (%) of patients who died on or before end of study (EOS) was compared among all 5 groups. The mITT population was used.||||0.3962
72625991|NCT00261833|144781706|SUPERIORITY_OR_OTHER||Difference in lung density(adjusted P15)|0.89||||0.115|TWO_SIDED|95.0|-0.57|2.34||A 1-sided P-value less than 0.025 and a positive estimate of the treatment difference Zemaira® minus placebo (ie, the lower bound of the 95% CI being greater than zero) will indicate superiority of Zemaira® compared with Placebo.|95% confidence interval||A mixed model ANCOVA was used to estimate the 95% CI for the difference (Zemaira® - placebo) in the change in lung density.|Analysis of the change in lung density (FRC) from baseline to Month 24 was a mixed effects ANCOVA model with country, treatment, and baseline lung density as fixed effects as a repeated random effect at a 1-sided significance level of 0.025.||2.34|-0.57|0.115
72531915|NCT02046993|144593139|SUPERIORITY_OR_OTHER|||||||0.27|||||||Chi-squared|||comparison of the percentage of patients doing HBPM between intervention and control group at baseline||||0.27
72531916|NCT02046993|144593139|SUPERIORITY_OR_OTHER|||||||0.02|||||||McNemar|||Comparison of percentage of subjects doing HBPM at 3rd month from baseline within intervention group||||.020
72531917|NCT02046993|144593139|SUPERIORITY_OR_OTHER|||||||0.06|||||||McNemar|||comparison in percentage of patients doing Home BP monitoring at 6th month from baseline within intervention group||||.060
72531918|NCT02046993|144593139|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED||||||McNemar|||Change in the proportion of patients doing HBPM at 3 months from baseline within the control group||||.002
72531919|NCT02046993|144593139|SUPERIORITY_OR_OTHER|||||||0.009|TWO_SIDED||||||McNemar|||Change in proportion of patients doing HBPM at 6 months from baseline within control group||||.009
72531920|NCT02046993|144593140|SUPERIORITY_OR_OTHER|||||||0.813|||||||t-test, 2 sided|||Comparison of baseline mean clinic systolic BP mCSBP readings between control and intervention||||0.813
72531921|NCT02046993|144593140|SUPERIORITY_OR_OTHER|||||||0.865|||||||t-test, 2 sided|||Comparison of baseline mean clinic diastolic BP mCDBP readings between control and intervention||||0.865
72531922|NCT02046993|144593140|SUPERIORITY_OR_OTHER|||||||0.476|||||||t-test, 2 sided|||Comparison of difference of mean clinic systolic BP readings mCSBP between control and intervention at 3 months from baseline||||0.476
72531923|NCT02046993|144593140|SUPERIORITY_OR_OTHER|||||||0.14|||||||t-test, 2 sided|||Comparison of difference of mean clinic diastolic BP mCDBP readings between control and intervention at 3 months from baseline||||0.14
72531924|NCT02046993|144593140|SUPERIORITY_OR_OTHER|||||||0.495|||||||t-test, 2 sided|||Comparison of difference of mean clinic systolic BP readings mCSBP between control and intervention at 6 months from baseline||||0.495
72531925|NCT02046993|144593140|SUPERIORITY_OR_OTHER|||||||0.967|||||||t-test, 2 sided|||Comparison of difference in mean clinic diastolic BP readings mCDBP between control and intervention at 6 months from baseline||||0.967
72531926|NCT02046993|144593141|SUPERIORITY_OR_OTHER|||||||0.819|||||||t-test, 2 sided|||Comparison of baselline SEMCD between telemonitoring group and enhanced usual care||||0.819
72531927|NCT02046993|144593141|SUPERIORITY_OR_OTHER|||||||0.512|||||||t-test, 2 sided|||Comparison of SEMCD at 3 months between telemonitoring group and enhanced usual care||||0.512
72531928|NCT02046993|144593141|SUPERIORITY_OR_OTHER|||||||0.325|||||||t-test, 2 sided|||Comparison of SEMCD at 6 months between telemonitoring group and enhanced usual care group||||0.325
72531929|NCT02046993|144593142|SUPERIORITY_OR_OTHER|||||||0.532|||||||t-test, 2 sided|||comparison of baseline mHSBP in mmHg between Telemonitoring and Enhanced Usual Care groups||||0.532
72531930|NCT02046993|144593142|SUPERIORITY_OR_OTHER|||||||0.902|||||||t-test, 2 sided|||comparison of baseline mHDBP in mmHg between Telemonitoring and Enhanced Usual Care groups||||0.902
72531931|NCT02046993|144593143|SUPERIORITY_OR_OTHER|||||||0.138|||||||t-test, 2 sided|||comparison of mHSBP at 3 months between smartphone based telemonitoring group and control group on enhanced usual care||||0.138
72531932|NCT02046993|144593143|SUPERIORITY_OR_OTHER|||||||0.204|||||||t-test, 2 sided|||comparison of mHDBP in mmHg between Telemonitoring and Enhanced Usual Care groups at 3 months||||0.204
72531933|NCT02046993|144593144|SUPERIORITY_OR_OTHER|||||||0.199|||||||t-test, 2 sided|||comparison of mHSBP in mmHg between Telemonitoring groups and Enhanced Usual Care groups at 6 months||||0.199
72531934|NCT02046993|144593144|SUPERIORITY_OR_OTHER|||||||0.204|||||||t-test, 2 sided|||comparison of mHDBP in mmHg at 6 months between Telemonitoring and Enhanced Usual Care groups||||0.204
72531935|NCT00598442|144593146|NON_INFERIORITY_OR_EQUIVALENCE|A non-inferiority margin of -1.0 g/dL was used in the primary efficacy assessments. Non-inferiority was established if the lower limit of the two-sided 97.5% CI for the difference between the means of the primary endpoint (peginesatide minus control ESA) was ≥ -1.0 g/dL.|Least Squares Mean Difference|0.14|STANDARD_ERROR_OF_MEAN|0.101|||TWO_SIDED|97.5|-0.09|0.36|||ANOVA|The ANOVA cell means model was used to estimate primary efficacy endpoint within the specified cells formed by the combination of treatment and strata||The sample size for this study was determined based on a two-group evaluation of non-inferiority in means with a non-inferiority margin (Δ) of -1.0 g/dL (one-sided significance level of 0.0125, or, comparably, a two-sided significance level of 0.025). A sample size of 450 (150 per treatment group) provided power greater than 99% for the evaluation of non-inferiority, assuming an expected treatment difference of 0.0 g/dL and a pooled standard deviation of 1.5 g/dL.||0.36|-0.09|
72531936|NCT00598442|144593146|NON_INFERIORITY_OR_EQUIVALENCE|A non-inferiority margin of -1.0 g/dL was used in the primary efficacy assessments. Non-inferiority was established if the lower limit of the two-sided 97.5% CI for the difference between the means of the primary endpoint (peginesatide minus control ESA) was ≥ -1.0 g/dL.|Least Squares Mean Difference|0.31|STANDARD_ERROR_OF_MEAN|0.102|||TWO_SIDED|97.5|0.08|0.54|||ANOVA|The ANOVA cell means model was used to estimate primary efficacy endpoint within the specified cells formed by the combination of treatment and strata||The sample size for this study was determined based on a two-group evaluation of non-inferiority in means with a non-inferiority margin (Δ) of -1.0 g/dL (one-sided significance level of 0.0125, or, comparably, a two-sided significance level of 0.025). A sample size of 450 (150 per treatment group) provided power greater than 99% for the evaluation of non-inferiority, assuming an expected treatment difference of 0.0 g/dL and a pooled standard deviation of 1.5 g/dL.||0.54|0.08|
72531937|NCT00598442|144593147|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|2.28|||||TWO_SIDED|95.0|1.04|5.01|||Cochran-Mantel-Haenszel|||||5.01|1.04|
72531938|NCT00598442|144593147|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|2.1|||||TWO_SIDED|95.0|0.94|4.69|||Cochran-Mantel-Haenszel|||||4.69|0.94|
72531939|NCT00598442|144593148|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.96|||||TWO_SIDED|95.0|0.9|1.01|||Cochran-Mantel-Haenszel|||||1.01|0.90|
72625992|NCT00402987|144781724|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|11.7||||0.0003||95.0|5.5|17.9|||generalized linear model|p-value was calculated using Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||Null hypothesis: No difference in SPID2 (PI-VAS) at two hours between celecoxib 100 mg and placebo. Sample size was based on an expected effect size of 0.42 (from earlier studies), 80% power and an alpha of 0.05.||17.9|5.5|0.0003
72625993|NCT00402987|144781725|SUPERIORITY_OR_OTHER_LEGACY|||||||0.212||95.0||||"Analysis at 15 min~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.212
72625994|NCT00402987|144781725|SUPERIORITY_OR_OTHER_LEGACY|||||||0.056||95.0||||"Analysis at 30 min~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.056
72625995|NCT00402987|144781725|SUPERIORITY_OR_OTHER_LEGACY|||||||0.005||95.0||||"Analysis at 45 min~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.005
72625996|NCT00402987|144781725|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002||95.0||||"Analysis at 60 min~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.002
72625997|NCT00402987|144781725|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 75 min~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
72625998|NCT00402987|144781725|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 90 min~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
72625999|NCT00402987|144781725|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 1.75 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
72626000|NCT00402987|144781725|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 2 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
72626001|NCT00402987|144781725|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 3 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
72531940|NCT00598442|144593148|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.98|||||TWO_SIDED|95.0|0.93|1.04|||Cochran-Mantel-Haenszel|||||1.04|0.93|
72531941|NCT02735382|144593173|SUPERIORITY||Odds Ratio (OR)|4.663|||<|0.0001|TWO_SIDED|95.0|4.116|5.283|||Chi-squared, Corrected|||||5.283|4.116|<.0001
72531942|NCT02735382|144593174|SUPERIORITY||Odds Ratio (OR)|3.284|||<|0.0001|TWO_SIDED|95.0|2.672|4.035|||Chi-squared, Corrected|||||4.035|2.672|<.0001
72531943|NCT02735382|144593175|SUPERIORITY||Odds Ratio (OR)|0.885||||0.8438|TWO_SIDED|95.0|0.42|1.698|||Chi-squared, Corrected|||||1.698|0.420|.8438
72626002|NCT00402987|144781725|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 4 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
72626003|NCT00402987|144781725|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 5 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
72626004|NCT00402987|144781725|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 6 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
72626005|NCT00402987|144781726|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001||95.0||||"Analysis at 7 hours~Overall P-value"|Generalized Linear Model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.001
72626006|NCT00402987|144781726|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 8 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
72626007|NCT00402987|144781726|SUPERIORITY_OR_OTHER_LEGACY|||||||0.006||95.0||||"Analysis at 9 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.006
72626008|NCT00402987|144781726|SUPERIORITY_OR_OTHER_LEGACY|||||||0.007||95.0||||"Analysis at 10 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.007
72626009|NCT00402987|144781726|SUPERIORITY_OR_OTHER_LEGACY|||||||0.014||95.0||||"Analysis at 11 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.014
72626010|NCT00402987|144781726|SUPERIORITY_OR_OTHER_LEGACY|||||||0.012||95.0||||"Analysis at 12 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.012
72531944|NCT02735382|144593176|SUPERIORITY||Mean Difference (Final Values)|0.44|STANDARD_ERROR_OF_MEAN|0.161||0.007|TWO_SIDED|95.0|0.123|0.757|||t-test, 2 sided|df=292||A change score from baseline to 6-months was computed and served as the data to be analyzed in the t-test of group differences.||0.757|0.123|.007
72626011|NCT00402987|144781726|SUPERIORITY_OR_OTHER_LEGACY|||||||0.365||95.0||||"Analysis at 24 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.365
72626012|NCT00402987|144781727|SUPERIORITY_OR_OTHER_LEGACY|||||||0.18||95.0||||"Analysis at 15 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized Linear Model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.180
72626013|NCT00402987|144781727|SUPERIORITY_OR_OTHER_LEGACY|||||||0.069||95.0||||"Analysis at 30 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.069
72626014|NCT00402987|144781727|SUPERIORITY_OR_OTHER_LEGACY|||||||0.01||95.0||||"Analysis at 45 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.010
72369204|NCT00611026|144248554|SUPERIORITY_OR_OTHER|||||||0.0072|TWO_SIDED|||||Comparison fesoterodine vs tolterodine ER performed only if statistical significance favoring fesoterodine achieved for fesoterodine vs placebo to preserve overall alpha level at 5%; pairwise comparison also performed for tolterodine ER vs placebo.|Van Elteren's test|P-value based on Van Elteren's Test (a stratified Wilcoxon-Mann Whitney test) adjusted by baseline UUI quartile.||Treatment difference fesoterodine vs tolterodine ER at Week 12. Treatment effects estimated by Winsorized means (5% of the tails were censored, ie, replaced with the value at the 5th and 95th percentile, respectively).||||0.0072
72531945|NCT05489146|144593177|SUPERIORITY|||||||0.046|||||||Mixed Models Analysis|||||||0.046
72531946|NCT05489146|144593178|SUPERIORITY|||||||0.003|||||||Mixed Models Analysis|||||||0.003
72531947|NCT05489146|144593179|SUPERIORITY||||||>|0.05|||||||Mixed Models Analysis|||||||>0.05
72531948|NCT05489146|144593180|SUPERIORITY||||||>|0.05|||||||ANCOVA|||||||>0.05
72531949|NCT05489146|144593181|SUPERIORITY||||||>|0.05|||||||Mixed Models Analysis|||||||>0.05
72531950|NCT05489146|144593182|SUPERIORITY||||||>|0.05|||||||Mixed Models Analysis|||||||>0.05
72531951|NCT05489146|144593183|SUPERIORITY|||||||0.001|||||||Mixed Models Analysis|||||||0.001
72531952|NCT05489146|144593184|SUPERIORITY|||||||0.035|||||||Mixed Models Analysis|||||||0.035
72531953|NCT00078715|144593202|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-1.004|STANDARD_ERROR_OF_MEAN|1.141||0.527|TWO_SIDED|95.0|-4.26|2.251||The significance level reflects the direct comparison of drugs after factoring out baseline depression levels.|Mixed Models Analysis|A linear mixed model was used with factors for drug, time of evaluation, the drug by time interaction, and a baseline depression covariate.||The hypothesis was that yohimbine would provide lower levels of depression than placebo. Initial estimates of sample size assumed a minimum of 25 patients were required to detect differences in depression.||2.251|-4.260|.527
72531954|NCT00911508|144593213|SUPERIORITY||Cox Proportional Hazard|0.86|||||TWO_SIDED|95.0|0.65|1.15||||||||1.15|0.65|
72531955|NCT00911508|144593214|SUPERIORITY||Cox Proportional Hazard|0.85|||||TWO_SIDED|95.0|0.6|1.21||||||||1.21|0.60|
72531956|NCT00911508|144593215|SUPERIORITY||Cox Proportional Hazard|0.83|||||TWO_SIDED|95.0|0.74|0.93||||||||0.93|0.74|
72531957|NCT00911508|144593216|SUPERIORITY||Cox Proportional Hazard|0.88|||||TWO_SIDED|95.0|0.72|1.09||||||||1.09|0.72|
72531958|NCT00911508|144593217|SUPERIORITY||Cox Proportional Hazard|0.94|||||TWO_SIDED|95.0|0.53|1.68||||||||1.68|0.53|
72531959|NCT00911508|144593218|SUPERIORITY||Cox Proportional Hazard|0.87|||||TWO_SIDED|95.0|0.51|1.51||||||||1.51|0.51|
72531960|NCT00911508|144593219|SUPERIORITY||Cox Proportional Hazard|0.76|||||TWO_SIDED|95.0|0.33|1.72||||||||1.72|0.33|
72531961|NCT00911508|144593220|SUPERIORITY||Cox Proportional Hazard|1.13|||||TWO_SIDED|95.0|0.41|3.09||||||||3.09|0.41|
72531962|NCT00911508|144593221|SUPERIORITY||Cox Proportional Hazard|0.52|||||TWO_SIDED|95.0|0.45|0.6||||||||0.60|0.45|
72531963|NCT00911508|144593222|SUPERIORITY||Cox Proportional Hazard|0.86|||||TWO_SIDED|95.0|0.77|0.97||||||||0.97|0.77|
72531964|NCT00911508|144593223|SUPERIORITY||Mean Difference (Net)|5.3|||<|0.001|TWO_SIDED|95.0|3.7|6.9|||Mixed Models Analysis|||12 Month||6.9|3.7|<0.001
72531965|NCT00911508|144593223|SUPERIORITY||Mean Difference (Net)|3.4|||<|0.001|TWO_SIDED|95.0|2.1|4.8|||Mixed Models Analysis|||5 Years||4.8|2.1|<0.001
72531966|NCT00911508|144593224|SUPERIORITY||Mean Difference (Net)|-1.7||||0.001|TWO_SIDED|95.0|-2.3|-1.2|||Mixed Models Analysis|||12 Month||-1.2|-2.3|0.001
72531967|NCT00911508|144593224|SUPERIORITY||Mean Difference (Net)|-1.4||||0.001|TWO_SIDED|95.0|-1.9|-0.9|||Mixed Models Analysis|||5 Year||-0.9|-1.9|0.001
72531968|NCT00911508|144593225|SUPERIORITY||Mean Difference (Net)|-1.5|||<|0.001|TWO_SIDED|95.0|-2.0|-1.1|||Mixed Models Analysis|||12 Month||-1.1|-2.0|<0.001
72531969|NCT00911508|144593225|SUPERIORITY||Mean Difference (Net)|-1.0|||<|0.001|TWO_SIDED|95.0|-1.7|-0.4|||Mixed Models Analysis|||5 Year||-0.4|-1.7|<0.001
72531970|NCT01409382|144593229|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.4|STANDARD_DEVIATION|1.0|<|0.05|TWO_SIDED|95.0|1.5|7.6|||Chi-squared|||Take home babies||7.6|1.5|<0.05
72531971|NCT01336647|144593231|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The primary efficacy endpoint was responder rate calculated based on the percentage of subjects who were lice free at all follow-up visits (Days 1, 7 and 14). Because the number of responders and non-responders in the family size\>= 5 household members was less than five in at least one of the treatment arms, (Table 14.2.1.5), Fisher's Exact test was used to compare treatment arms, instead of the CMH test.|||||<|0.001|TWO_SIDED|95.0|||||Fisher Exact|The assessment of statistical significance will be done using Hochberg's modified Bonferroni test.||Null hypothesis; 80% power and 0.025 two-sided level of significance for each pairwise active vs. vehicle comparison||||<0.001
72531972|NCT02022566|144593249|OTHER||||||<|0.05|TWO_SIDED|95.0|||||ANOVA|||||||<0.05
72531973|NCT02022566|144593250|OTHER|Described elsewhere|Mean Difference (Final Values)|0.05|||<|0.05|TWO_SIDED|95.0|||||ANOVA|||||||<0.05
72531974|NCT00665366|144593262|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.04||||0.058|TWO_SIDED|95.0|-4.14|0.07|||ANCOVA|||||0.07|-4.14|0.058
72531975|NCT00665366|144593263|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.05||||0.669|TWO_SIDED|95.0|-0.16|0.25|||ANOVA/ANCOVA||Week 3|||0.25|-0.16|0.669
72531976|NCT00665366|144593263|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1||||0.436|TWO_SIDED|95.0|-0.36|0.16|||ANOVA/ANCOVA||Week 6|||0.16|-0.36|0.436
72531977|NCT00665366|144593263|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.28||||0.053|TWO_SIDED|95.0|-0.56|0.0|||ANOVA/ANCOVA||Week 9|||0.00|-0.56|0.053
72531978|NCT00665366|144593263|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3||||0.044|TWO_SIDED|95.0|-0.59|-0.01|||ANOVA/ANCOVA||Week 12|||-0.01|-0.59|0.044
72531979|NCT00665366|144593264|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.08||||0.24|TWO_SIDED|95.0|-0.22|0.06|||ANOVA/ANCOVA model||Week 3|||0.06|-0.22|0.240
72531980|NCT00665366|144593264|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.02||||0.843|TWO_SIDED|95.0|-0.15|0.19|||ANOVA/ANCOVA model||Week 6|||0.19|-0.15|0.843
72531981|NCT00665366|144593264|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.16||||0.117|TWO_SIDED|95.0|-0.04|0.35|||ANOVA/ANCOVA model||Week 9|||0.35|-0.04|0.117
72531982|NCT00665366|144593264|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.17||||0.109|TWO_SIDED|95.0|-0.04|0.38|||ANOVA/ANCOVA model|Week 12||||0.38|-0.04|0.109
72531983|NCT00665366|144593265|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.08||||0.567|TWO_SIDED|95.0|-0.37|0.2|||ANOVA/ANCOVA model|Week 12||||0.20|-0.37|0.567
72531984|NCT00665366|144593266|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.68||||0.566|TWO_SIDED|95.0|-1.66|3.03|||ANCOVA||Total score: Week 3|||3.03|-1.66|0.566
72626015|NCT00402987|144781727|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002||95.0||||"Analysis at 60 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.002
72626016|NCT00402987|144781727|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 75 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
72626017|NCT00402987|144781727|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 90 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
72626018|NCT00402987|144781727|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 1.75 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
72626019|NCT00402987|144781727|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 2 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
72626020|NCT00402987|144781727|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 3 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
72626021|NCT00402987|144781727|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 4 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
72626022|NCT00402987|144781727|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 5 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
72626023|NCT00402987|144781727|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 6 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
72626024|NCT00402987|144781727|SUPERIORITY_OR_OTHER_LEGACY|||||||0.096||95.0||||"Analysis at 15 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.096
72626025|NCT00402987|144781727|SUPERIORITY_OR_OTHER_LEGACY|||||||0.034||95.0||||"Analysis at 30 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.034
72626026|NCT00402987|144781727|SUPERIORITY_OR_OTHER_LEGACY|||||||0.022||95.0||||"Analysis at 45 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.022
72626027|NCT00402987|144781727|SUPERIORITY_OR_OTHER_LEGACY|||||||0.01||95.0||||"Analysis at 60 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.010
72626028|NCT00402987|144781727|SUPERIORITY_OR_OTHER_LEGACY|||||||0.005||95.0||||"Analysis at 75 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.005
72531985|NCT00665366|144593266|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.66||||0.221||95.0|-1.0|4.32|||ANCOVA||Total score: Week 6|||4.32|-1.00|0.221
72531986|NCT00665366|144593266|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.47||||0.315|TWO_SIDED|95.0|-1.4|4.35|||ANCOVA||Total score: Week 9|||4.35|-1.40|0.315
72531987|NCT00665366|144593266|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.88||||0.212|TWO_SIDED|95.0|-1.08|4.84|||ANCOVA||Total score: Week 12|||4.84|-1.08|0.212
72531988|NCT00665366|144593266|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.991|TWO_SIDED|95.0|-0.49|0.48|||ANCOVA||Autonomy score: Week 3|||0.48|-0.49|0.991
72531989|NCT00665366|144593266|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.34||||0.201|TWO_SIDED|95.0|-0.18|0.85|||ANCOVA||Autonomy score: Week 6|||0.85|-0.18|0.201
72531990|NCT00665366|144593266|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.37||||0.198|TWO_SIDED|95.0|-0.19|0.93|||ANCOVA||Autonomy score: Week 9|||0.93|-0.19|0.198
72531991|NCT00665366|144593266|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.39||||0.178|TWO_SIDED|95.0|-0.18|0.96|||ANCOVA||Autonomy score: Week 12|||0.96|-0.18|0.178
72531992|NCT00665366|144593266|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.34||||0.311|TWO_SIDED|95.0|-1.01|0.32|||ANCOVA||Occupational functioning score: Week 3|||0.32|-1.01|0.311
72531993|NCT00665366|144593266|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.17||||0.671|TWO_SIDED|95.0|-0.94|0.61|||ANCOVA||Occupational functioning score: Week 6|||0.61|-0.94|0.671
72531994|NCT00665366|144593266|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02||||0.968|TWO_SIDED|95.0|-0.83|0.79|||ANCOVA||Occupational functioning score: Week 9|||0.79|-0.83|0.968
72531995|NCT00665366|144593266|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.25||||0.546|TWO_SIDED|95.0|-0.56|1.07|||ANCOVA||Occupational functioning score: Week 12|||1.07|-0.56|0.546
72531996|NCT00665366|144593266|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.34||||0.284|TWO_SIDED|95.0|-0.28|0.96|||ANCOVA||Cognitive functioning score: Week 3|||0.96|-0.28|0.284
72531997|NCT00665366|144593266|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.66||||0.063|TWO_SIDED|95.0|-0.04|1.35|||ANCOVA||Cognitive functioning score: Week 6|||1.35|-0.04|0.063
72531998|NCT00665366|144593266|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.62||||0.09|TWO_SIDED|95.0|-0.1|1.34|||ANCOVA||Cognitive functioning score: Week 9|||1.34|-0.10|0.090
72531999|NCT00665366|144593266|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.68||||0.072|TWO_SIDED|95.0|-0.06|1.42|||ANCOVA||Cognitive functioning score: Week 12|||1.42|-0.06|0.072
72626029|NCT00402987|144781727|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002||95.0||||"Analysis at 90 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.002
72626030|NCT00402987|144781727|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001||95.0||||"Analysis at 1.75 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.001
72626031|NCT00402987|144781727|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 2 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
72626032|NCT00402987|144781727|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 3 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
72626033|NCT00402987|144781727|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 4 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
72626034|NCT00402987|144781727|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 5 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
72626035|NCT00402987|144781727|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 6 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
72408005|NCT03238911|144324423|SUPERIORITY||Mean Difference (Final Values)|1.03|||<|0.0001|TWO_SIDED|95.0|0.75|1.32|||Mixed model for repeated measures|||"Day 21~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||1.32|0.75|<0.0001
72532000|NCT00665366|144593266|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.24||||0.499|TWO_SIDED|95.0|-0.45|0.93|||ANCOVA||Interpersonal relationships score: Week 3|||0.93|-0.45|0.499
72532001|NCT00665366|144593266|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.29||||0.457|TWO_SIDED|95.0|-0.48|1.06|||ANCOVA||Interpersonal relationships score: Week 6|||1.06|-0.48|0.457
72532002|NCT00665366|144593266|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.27||||0.525||95.0|-0.56|1.1|||ANCOVA||Interpersonal relationships score: Week 9|||1.10|-0.56|0.525
72532003|NCT00665366|144593266|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.26||||0.544|TWO_SIDED|95.0|-0.58|1.09|||ANCOVA||Interpersonal relationships score: Week 12|||1.09|-0.58|0.544
72532004|NCT00665366|144593266|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.22||||0.149|TWO_SIDED|95.0|-0.08|0.52|||ANCOVA||Leisure time score: Week 3|||0.52|-0.08|0.149
72532005|NCT00665366|144593266|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.19||||0.264|TWO_SIDED|95.0|-0.15|0.54|||ANCOVA||Leisure time score: Week 6|||0.54|-0.15|0.264
72532006|NCT00665366|144593266|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.988|TWO_SIDED|95.0|-0.35|0.35|||ANCOVA||Leisure time score: Week 9|||0.35|-0.35|0.988
72532007|NCT00665366|144593266|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.08||||0.641|TWO_SIDED|95.0|-0.27|0.44|||ANCOVA||Leisure time score: Week 12|||0.44|-0.27|0.641
72532008|NCT00665366|144593266|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.29||||0.068|TWO_SIDED|95.0|-0.02|0.61|||ANCOVA||Financial issues score: Week 3|||0.61|-0.02|0.068
72532009|NCT00665366|144593266|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.4||||0.019|TWO_SIDED|95.0|0.07|0.74|||ANCOVA||Financial issues score: Week 6|||0.74|0.07|0.019
72532010|NCT00665366|144593266|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.26||||0.136|TWO_SIDED|95.0|-0.08|0.6|||ANCOVA||Financial issues score: Week 9|||0.60|-0.08|0.136
72532011|NCT00665366|144593266|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.23||||0.18||95.0|-0.11|0.57|||ANCOVA||Financial issues score: Week 12|||0.57|-0.11|0.18
72532012|NCT00665366|144593267|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.13||||0.466|TWO_SIDED|95.0|0.81|1.59|||Ration of response||Week 3|||1.59|0.81|0.466
72532013|NCT00665366|144593267|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.07||||0.54|TWO_SIDED|95.0|0.86|1.32|||Risk ratio||Week 6|||1.32|0.86|0.540
72626036|NCT00402987|144781727|SUPERIORITY_OR_OTHER_LEGACY|||||||0.741||95.0||||"Analysis at 15 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.741
72626037|NCT00402987|144781727|SUPERIORITY_OR_OTHER_LEGACY|||||||0.759||95.0||||"Analysis at 30 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.759
72532014|NCT00665366|144593267|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.17||||0.06|TWO_SIDED|95.0|0.99|1.38|||Risk ratio||Week 9|||1.38|0.99|0.060
72532015|NCT00665366|144593267|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.07||||0.289|TWO_SIDED|95.0|0.94|1.23|||Risk ratio|||||1.23|0.94|0.289
72626038|NCT00402987|144781727|SUPERIORITY_OR_OTHER_LEGACY|||||||0.775||95.0||||"Analysis at 45 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.775
72626039|NCT00402987|144781727|SUPERIORITY_OR_OTHER_LEGACY|||||||0.561||95.0||||"Analysis at 60 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.561
72626040|NCT00402987|144781727|SUPERIORITY_OR_OTHER_LEGACY|||||||0.419||95.0||||"Analysis at 75 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.419
72626041|NCT00402987|144781727|SUPERIORITY_OR_OTHER_LEGACY|||||||0.237||95.0||||"Analysis at 90 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.237
72626042|NCT00402987|144781727|SUPERIORITY_OR_OTHER_LEGACY|||||||0.146||95.0||||"Analysis at 1.75 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.146
72626043|NCT00402987|144781727|SUPERIORITY_OR_OTHER_LEGACY|||||||0.113||95.0||||"Analysis at 2 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.113
72626044|NCT00402987|144781727|SUPERIORITY_OR_OTHER_LEGACY|||||||0.086||95.0||||"Analyaia at 3 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.086
72626045|NCT00402987|144781727|SUPERIORITY_OR_OTHER_LEGACY|||||||0.111||95.0||||"Analysis at 4 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.111
72626046|NCT00402987|144781727|SUPERIORITY_OR_OTHER_LEGACY|||||||0.183||95.0||||"Analysis at 5 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.183
72626047|NCT00402987|144781727|SUPERIORITY_OR_OTHER_LEGACY|||||||0.259||95.0||||"Analysis at 6 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.259
72626048|NCT00402987|144781728|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 7 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
72626049|NCT00402987|144781728|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 8 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
72572221|NCT02912650|144671814|SUPERIORITY_OR_OTHER||CMH adjusted proportions|58.12|||<|0.001|TWO_SIDED|95.0|45.24|71.0|||Cochran-Mantel-Haenszel|||10 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||71.00|45.24|<0.001
72408006|NCT03238911|144324423|SUPERIORITY||Mean Difference (Final Values)|1.13|||<|0.0001|TWO_SIDED|95.0|0.86|1.39|||Mixed model for repeated measures|||"Day 35~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||1.39|0.86|<0.0001
72532016|NCT00665366|144593268|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.02||||0.909|TWO_SIDED|95.0|0.75|1.39|||Risk ratio (RR)||Week 3|||1.39|0.75|0.909
72532017|NCT00665366|144593268|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.06||||0.573|TWO_SIDED|95.0|0.86|1.3|||RR||Week 6|||1.30|0.86|0.573
72532018|NCT00665366|144593268|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.16||||0.08|TWO_SIDED|95.0|0.98|1.36|||RR||Week 9|||1.36|0.98|0.080
72532019|NCT00665366|144593268|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.1||||0.211|TWO_SIDED|95.0|0.95|1.27|||RR||Week 12|||1.27|0.95|0.211
72532020|NCT00665366|144593269|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.68|||||TWO_SIDED|95.0|0.07|1.29|||ANOVA/ANCOVA model||Week 6|||1.29|0.07|
72532021|NCT00665366|144593269|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.83||||0.031|TWO_SIDED|95.0|0.08|1.58|||ANOVA/ANCOVA model||Week 12|||1.58|0.08|0.031
72532022|NCT00665366|144593269|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.61||||0.104|TWO_SIDED|95.0|-0.13|1.34|||ANOVA/ANCOVA model||Week 12 (LOCF)|||1.34|-0.13|0.104
72532023|NCT00665366|144593270|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.06|||||TWO_SIDED|95.0|-0.21|0.32|||ANCOVA||Week 3|||0.32|-0.21|
72572222|NCT02912650|144671814|SUPERIORITY_OR_OTHER||CMH adjusted proportions|7.23||||0.071||95.0|-0.63|15.1|||Cochran-Mantel-Haenszel|||10 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||15.10|-0.63|0.071
72626050|NCT00402987|144781728|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 9 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
72626051|NCT00402987|144781728|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 10 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
72626052|NCT00402987|144781728|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 11 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
72626053|NCT00402987|144781728|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 12 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
72626054|NCT00402987|144781728|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 24 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
72626055|NCT00402987|144781728|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 7 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
72626056|NCT00402987|144781728|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 8 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
72626057|NCT00402987|144781728|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 9 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
72532024|NCT00665366|144593270|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.24|||||TWO_SIDED|95.0|-0.05|0.53|||ANCOVA||Week 6|||0.53|-0.05|
72626058|NCT00402987|144781728|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 10 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
72626059|NCT00402987|144781728|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 12 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
72626060|NCT00402987|144781728|SUPERIORITY_OR_OTHER_LEGACY|||||||0.017||95.0||||"Analysis at 24 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.017
72626061|NCT00402987|144781728|SUPERIORITY_OR_OTHER_LEGACY|||||||0.011||95.0||||"Analysis at 7 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.011
72532025|NCT00665366|144593270|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.21||||0.197|TWO_SIDED|95.0|-0.11|0.54|||ANCOVA||Week 12|||0.54|-0.11|0.197
72532026|NCT00665366|144593270|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.28||||0.111|TWO_SIDED|95.0|-0.07|0.63|||ANCOVA||Week 12 (LOCF)|||0.63|-0.07|0.111
72532027|NCT00665366|144593271|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01||||0.983|TWO_SIDED|95.0|-0.63|0.64|||ANOVA/ANCOVA model||Week 12 LOCF|||0.64|-0.63|0.983
72532028|NCT00665366|144593272|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.45|||||TWO_SIDED|95.0|0.57|3.71|||Risk Ratio|Weight gain||||3.71|0.57|
72532029|NCT00665366|144593273|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.582||95.0|||||ANCOVA|||||||0.582
72532030|NCT00994123|144593277|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.35||||0.008|TWO_SIDED|95.0|0.16|0.76|||Log Rank|||||0.76|0.16|0.008
72532031|NCT00994123|144593277|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.15||||0.059|TWO_SIDED|95.0|0.97|4.76|||Log Rank|||||4.76|0.97|0.059
72532032|NCT05111548|144593284|SUPERIORITY|||||||0.923|||||||ANOVA|||Mixed ANOVA (within-subjects factor=time; between-subjects factor=group)||||0.923
72532033|NCT05111548|144593285|SUPERIORITY|||||||0.11|||||||ANOVA|||Mixed ANOVA (within-subjects factor=time; between-subjects factor=group)||||0.110
72532034|NCT05111548|144593286|SUPERIORITY|||||||0.818|||||||ANOVA|||Mixed ANOVA (within-subjects factor=time; between-subjects factor=group)||||0.818
72532035|NCT05111548|144593287|SUPERIORITY|||||||0.13|||||||ANOVA|||Mixed ANOVA (within-subjects factor=time; between-subjects factor=group)||||0.130
72532036|NCT03330275|144593294|NON_INFERIORITY|A non-inferiority margin of -0.25 was used. Non-inferioirty was concluded if the lower limit of the 95% CI was above 0.25.|Mean Difference (Final Values)|0.069|STANDARD_ERROR_OF_MEAN|0.0574|||TWO_SIDED|95.0|-0.045|0.183|||Linear Mixed Model|Kenward and Roger Method was used for denominator degrees of freedom|Mean difference was calculated as Test - Control 1|It was calculated that a total of 24 participants was required to show that the Test lens is non-inferior to the control 1 lens with 80% power. Sample size for this study was based on night driving only.||0.183|-0.045|
72532037|NCT03330275|144593295|NON_INFERIORITY|A non-inferiority margin of 0.1 logMAR was used. Non-inferiority was concluded if the upper limit was below 0.1.|Mean Difference (Final Values)|-0.028|STANDARD_ERROR_OF_MEAN|0.0076|||TWO_SIDED|95.0|-0.043|-0.012|||Linear Mixed Model|Kenward and Roger Method was used for the degrees of freedom.|Mean difference was calculated as Test - Control 1|||-0.012|-0.043|
72532038|NCT03330275|144593296|EQUIVALENCE|Equivalence was concluded if 0 was contained in the 95% confidence interval.|Odds Ratio (OR)|3.162|||||TWO_SIDED|95.0|0.442|22.604|||Generalized Estimating Equation||Odds ratio was calculated as Test over Control 1|||22.604|0.442|
72532039|NCT03330275|144593297|EQUIVALENCE|Equivalence was concluded if 0 was contained in the 95% confidence interval.|Odds Ratio (OR)|0.98|||||TWO_SIDED|95.0|0.82|1.16|||Generalized Linear Mixed Model||Odds ratio was calculated as Test over Control1|||1.16|0.82|
72532040|NCT03330275|144593298|EQUIVALENCE|Equivalence was concluded if 0 was contained in the 95% confidence interval.|Mean Difference (Final Values)|17.8|STANDARD_ERROR_OF_MEAN|5.29|||TWO_SIDED|95.0|7.1|28.5|||Linear Mixed Model|Kenward and Roger Method was used for the denominator degrees of freedom.|Mean difference was calculated as Test - Control 1|||28.5|7.1|
72532041|NCT03330275|144593299|EQUIVALENCE|Equivalence was concluded if 0 was contained in the 95% confidence interval.|Odds Ratio (OR)|0.76|||||TWO_SIDED|95.0|0.33|1.74|||Generalized Linear Mixed Model||Odds Ratio was calculated as Test over Control 1|||1.74|0.33|
72532042|NCT03330275|144593300|EQUIVALENCE|Equivalence was concluded if 0 was contained in the 95% confidence interval.|Mean Difference (Final Values)|4.7|STANDARD_ERROR_OF_MEAN|7.93|||TWO_SIDED|95.0|-11.4|20.7|||Linear Mixed Model|Kenward and Roger Method was used for denominator Degrees of Freedom.|Mean difference was calculated as Test - Control 1|||20.7|-11.4|
72532043|NCT00151775|144593308|SUPERIORITY_OR_OTHER|||||||0.0008||95.0|||||Regression, Linear|||Non-weight adjusted dosage||||0.0008
72532044|NCT00151775|144593308|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Regression, Linear|||Weight adjusted dosage||||<0.0001
72532045|NCT00151775|144593308|SUPERIORITY_OR_OTHER|||||||0.0032||95.0|||||Regression, Linear|||Non-weight adjusted dosage||||0.0032
72532046|NCT00151775|144593308|SUPERIORITY_OR_OTHER|||||||0.0265||95.0|||||Regression, Linear|||Weight adjusted dosage||||0.0265
72532047|NCT00151775|144593308|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Regression, Linear|||Non-weight adjusted dosage||||<0.0001
72626062|NCT00402987|144781728|SUPERIORITY_OR_OTHER_LEGACY|||||||0.009||95.0||||"Analysis at 8 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.009
72626063|NCT00402987|144781728|SUPERIORITY_OR_OTHER_LEGACY|||||||0.008||95.0||||"Analysis at 9 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.008
72626064|NCT00402987|144781728|SUPERIORITY_OR_OTHER_LEGACY|||||||0.008||95.0||||"Analysis at 10 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.008
72626065|NCT00402987|144781728|SUPERIORITY_OR_OTHER_LEGACY|||||||0.008||95.0||||"Analysis at 11 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.008
72532048|NCT00151775|144593308|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Regression, Linear|||Weight adjusted dosage||||<0.0001
72532049|NCT00151775|144593309|SUPERIORITY_OR_OTHER||Slope|0.69||||0.0008||95.0|||||Regression, Linear|||A linear regression analysis of olmesartan dose (non-weight adjusted) on the change from baseline in seated systolic blood pressure was carried out. The null hypothesis of zero-slope was tested.||||0.0008
72532050|NCT00151775|144593309|SUPERIORITY_OR_OTHER||Slope|-0.057||||0.0026||95.0|||||Regression, Linear|||A linear regression analysis of olmesartan dose (non-weight adjusted) on the change from baseline in seated diastolic blood pressure was carried out. The null hypothesis of zero-slope was tested.||||0.0026
72532051|NCT00151775|144593309|SUPERIORITY_OR_OTHER||Slope|-0.85||||0.0032||95.0|||||Regression, Linear|||A linear regression analysis of olmesartan dose (non-weight adjusted) on the change from baseline in seated systolic blood pressure was carried out. The null hypothesis of zero-slope was tested.||||0.0032
72532052|NCT00151775|144593309|SUPERIORITY_OR_OTHER||Slope|-0.58||||0.0125||95.0|||||Regression, Linear|||A linear regression analysis of olmesartan dose (non-weight adjusted) on the change from baseline in seated diastolic blood pressure was carried out. The null hypothesis of zero-slope was tested.||||0.0125
72532053|NCT00151775|144593309|SUPERIORITY_OR_OTHER||Slope|-0.75|||<|0.0001||95.0|||||Regression, Linear|||A linear regression analysis of olmesartan dose (non-weight adjusted) on the change from baseline in seated systolic blood pressure was carried out. The null hypothesis of zero-slope was tested.||||<0.0001
72532054|NCT00151775|144593309|SUPERIORITY_OR_OTHER||Slope|-0.57|||<|0.0001||95.0|||||Regression, Linear|||A linear regression analysis of olmesartan dose (non-weight adjusted) on the change from baseline in seated diastolic blood pressure was carried out. The null hypothesis of zero-slope was tested.||||<0.0001
72532055|NCT00151775|144593309|SUPERIORITY_OR_OTHER||Slope|-8.97|||<|0.0001||95.0|||||Regression, Linear|||A linear regression analysis of olmesartan dose (weight adjusted) on the change from baseline in seated systolic blood pressure was carried out. The null hypothesis of zero-slope was tested.||||<0.0001
72532056|NCT00151775|144593309|SUPERIORITY_OR_OTHER||Slope|-8.15|||<|0.0001||95.0|||||Regression, Linear|||A linear regression analysis of olmesartan dose (weight adjusted) on the change from baseline in seated diastolic blood pressure was carried out. The null hypothesis of zero-slope was tested.||||<0.0001
72532057|NCT00151775|144593309|SUPERIORITY_OR_OTHER||Slope|-7.17||||0.0265||95.0|||||Regression, Linear|||A linear regression analysis of olmesartan dose (weight adjusted) on the change from baseline in seated systolic blood pressure was carried out. The null hypothesis of zero-slope was tested.||||0.0265
72532058|NCT00151775|144593309|SUPERIORITY_OR_OTHER||Slope|-6.85||||0.0084||95.0|||||Regression, Linear|||A linear regression analysis of olmesartan dose (weight adjusted) on the change from baseline in seated diastolic blood pressure was carried out. The null hypothesis of zero-slope was tested.||||0.0084
72532059|NCT00151775|144593309|SUPERIORITY_OR_OTHER||Slope|-8.36|||<|0.0001||95.0|||||Regression, Linear|||A linear regression analysis of olmesartan dose (weight adjusted) on the change from baseline in seated systolic blood pressure was carried out. The null hypothesis of zero-slope was tested.||||<0.0001
72532060|NCT00151775|144593309|SUPERIORITY_OR_OTHER||Slope|-7.71|||<|0.0001||95.0|||||Regression, Linear|||A linear regression analysis of olmesartan dose (weight adjusted) on the change from baseline in seated diastolic blood pressure was carried out. The null hypothesis of zero-slope was tested.||||<0.0001
72532061|NCT00151775|144593310|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.58||||0.0093|TWO_SIDED|95.0|-6.27|-0.89|||ANCOVA|The ANCOVA model used treatment and country as fixed effects and baseline as covariate.||Analysis of systolic blood pressure. Null hypothesis of no treatment difference was tested.||-0.89|-6.27|0.0093
72532062|NCT00151775|144593310|SUPERIORITY_OR_OTHER||LS Mean difference|-3.49||||0.0052|TWO_SIDED|95.0|-5.92|-1.05|||ANCOVA|The ANCOVA model used treatment and country as fixed effects and baseline as covariate.||Analysis for diastolic blood pressure. The null hypothesis of no treatment difference was tested.||-1.05|-5.92|0.0052
72532063|NCT00151775|144593310|SUPERIORITY_OR_OTHER||LS Mean difference|-2.57||||0.133|TWO_SIDED|95.0|-5.93|0.79|||ANCOVA|The ANCOVA model used treatment and country as fixed effects and baseline as covariate.||Analysis of systolic blood pressure. Null hypothesis of no treatment difference was tested.||0.79|-5.93|0.1330
72532064|NCT00151775|144593310|SUPERIORITY_OR_OTHER||LS Mean difference|-1.38||||0.3442|TWO_SIDED|95.0|-4.27|1.5|||ANCOVA|The ANCOVA model used treatment and country as fixed effects and baseline as covariate.||Analysis for diastolic blood pressure. The null hypothesis of no treatment difference was tested.||1.50|-4.27|0.3442
72532065|NCT00151775|144593310|SUPERIORITY_OR_OTHER||LS Mean difference|-3.16||||0.0029|TWO_SIDED|95.0|-5.24|-1.09|||ANCOVA|The ANCOVA model used treatment and country as fixed effects and baseline as covariate.||For seated systolic blood pressure the null hypothesis of no treatment difference was tested||-1.09|-5.24|0.0029
72532066|NCT00151775|144593310|SUPERIORITY_OR_OTHER||LS Mean difference|-2.8||||0.0032|TWO_SIDED|95.0|-4.65|-0.95|||ANCOVA|The ANCOVA model used treatment and country as fixed effects and baseline as covariate.||For seated diastolic blood pressure the null hypothesis of no treatment difference was tested.||-0.95|-4.65|0.0032
72532067|NCT00151775|144593311|SUPERIORITY_OR_OTHER||LS Mean difference|-2.82||||0.2113|TWO_SIDED|95.0|-7.29|1.65|||ANCOVA|The ANCOVA model used treatment and country as fixed effects and baseline as covariate.||For seated systolic blood pressure the null hypothesis of no treatment difference was tested.||1.65|-7.29|0.2113
72532068|NCT00151775|144593311|SUPERIORITY_OR_OTHER||LS Mean difference|-2.92||||0.1496|TWO_SIDED|95.0|-6.92|1.09|||ANCOVA|The ANCOVA model used treatment and country as fixed effects and baseline as covariate.||For seated diastolic blood pressure the null hypothesis of no treatment difference was tested.||1.09|-6.92|0.1496
72532069|NCT01008059|144593318|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<.05
72532070|NCT04516291|144593326|OTHER||Least Square (LS) Mean difference|-22.4|STANDARD_ERROR_OF_MEAN|4.93|<|0.001|TWO_SIDED|95.0|-32.1|-12.7|||Mixed Models Analysis|MMRM with baseline value, treatment, visit, interaction term of treatment by visit as fixed effects and unstructured covariance structure was used.||||-12.7|-32.1|<0.001
72532071|NCT04516291|144593326|OTHER||LS Mean difference|-22.0|STANDARD_ERROR_OF_MEAN|4.88|<|0.001|TWO_SIDED|95.0|-31.7|-12.4|||Mixed Models Analysis|MMRM with baseline value, treatment, visit, interaction term of treatment by visit as fixed effects and unstructured covariance structure was used.||||-12.4|-31.7|<0.001
72532072|NCT04516291|144593326|OTHER||LS Mean difference|-24.1|STANDARD_ERROR_OF_MEAN|5.05|<|0.001|TWO_SIDED|95.0|-34.1|-14.2|||Mixed Models Analysis|MMRM with baseline value, treatment, visit, interaction term of treatment by visit as fixed effects and unstructured covariance structure was used.||||-14.2|-34.1|<0.001
72626066|NCT00402987|144781728|SUPERIORITY_OR_OTHER_LEGACY|||||||0.008||95.0||||"Analysis at 12 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.008
72626067|NCT00402987|144781728|SUPERIORITY_OR_OTHER_LEGACY|||||||0.012||95.0||||"Analysis at 24 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.012
72626068|NCT00402987|144781728|SUPERIORITY_OR_OTHER_LEGACY|||||||0.904||95.0||||"Analysis at 7 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.904
72626069|NCT00402987|144781728|SUPERIORITY_OR_OTHER_LEGACY|||||||0.891||95.0||||"Analysis at 8 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.891
72626070|NCT00402987|144781728|SUPERIORITY_OR_OTHER_LEGACY|||||||0.929||95.0||||"Analysis at 9 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.929
72626071|NCT00402987|144781728|SUPERIORITY_OR_OTHER_LEGACY|||||||0.994||95.0||||"Analysis at 10 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.994
72532073|NCT04516291|144593326|OTHER||LS Mean difference|-27.7|STANDARD_ERROR_OF_MEAN|4.09|<|0.001|TWO_SIDED|95.0|-35.7|-19.6|||Mixed Models Analysis|MMRM with baseline value, treatment, visit, interaction term of treatment by visit as fixed effects and unstructured covariance structure was used.||||-19.6|-35.7|<0.001
72532074|NCT04516291|144593326|OTHER||LS Mean difference|-26.6|STANDARD_ERROR_OF_MEAN|3.98|<|0.001|TWO_SIDED|95.0|-34.5|-18.8|||Mixed Models Analysis|MMRM with baseline value, treatment, visit, interaction term of treatment by visit as fixed effects and unstructured covariance structure was used.||||-18.8|-34.5|<0.001
72532075|NCT04516291|144593326|OTHER||LS Mean difference|-24.7|STANDARD_ERROR_OF_MEAN|3.96|<|0.001|TWO_SIDED|95.0|-32.5|-16.9|||Mixed Models Analysis|MMRM with baseline value, treatment, visit, interaction term of treatment by visit as fixed effects and unstructured covariance structure was used.||||-16.9|-32.5|<0.001
72532076|NCT04516291|144593326|OTHER||LS Mean difference|-26.5|STANDARD_ERROR_OF_MEAN|4.51|<|0.001|TWO_SIDED|95.0|-35.4|-17.6|||Mixed Models Analysis|MMRM with baseline value, treatment, visit, interaction term of treatment by visit as fixed effects and unstructured covariance structure was used.||||-17.6|-35.4|<0.001
72532077|NCT04516291|144593328|OTHER||LS Mean difference|-44.0|STANDARD_ERROR_OF_MEAN|6.66|<|0.001|TWO_SIDED|95.0|-57.1|-30.8|||Mixed Models Analysis|MMRM with baseline value, treatment, visit, interaction term of treatment by visit as fixed effects and unstructured covariance structure was used.||TG||-30.8|-57.1|<0.001
72532078|NCT04516291|144593328|OTHER||LS Mean difference|-43.8|STANDARD_ERROR_OF_MEAN|6.64|<|0.001|TWO_SIDED|95.0|-56.9|-30.7|||Mixed Models Analysis|MMRM with baseline value, treatment, visit, interaction term of treatment by visit as fixed effects and unstructured covariance structure was used.||TG||-30.7|-56.9|<0.001
72532079|NCT04516291|144593328|OTHER||LS Mean difference|-41.3|STANDARD_ERROR_OF_MEAN|6.85|<|0.001|TWO_SIDED|95.0|-54.8|-27.8|||Mixed Models Analysis|MMRM with baseline value, treatment, visit, interaction term of treatment by visit as fixed effects and unstructured covariance structure was used.||TG||-27.8|-54.8|<0.001
72532080|NCT04516291|144593328|OTHER||LS Mean difference|-50.5|STANDARD_ERROR_OF_MEAN|5.54|<|0.001|TWO_SIDED|95.0|-61.4|-39.6|||Mixed Models Analysis|MMRM with baseline value, treatment, visit, interaction term of treatment by visit as fixed effects and unstructured covariance structure was used.||TG||-39.6|-61.4|<0.001
72532081|NCT04516291|144593328|OTHER||LS Mean difference|-45.9|STANDARD_ERROR_OF_MEAN|5.38|<|0.001|TWO_SIDED|95.0|-56.5|-35.2|||Mixed Models Analysis|MMRM with baseline value, treatment, visit, interaction term of treatment by visit as fixed effects and unstructured covariance structure was used.||TG||-35.2|-56.5|<0.001
72532082|NCT04516291|144593328|OTHER||LS Mean difference|-50.7|STANDARD_ERROR_OF_MEAN|5.35|<|0.001|TWO_SIDED|95.0|-61.2|-40.1|||Mixed Models Analysis|MMRM with baseline value, treatment, visit, interaction term of treatment by visit as fixed effects and unstructured covariance structure was used.||TG||-40.1|-61.2|<0.001
72626072|NCT00402987|144781728|SUPERIORITY_OR_OTHER_LEGACY|||||||0.933||95.0||||"Analysis at 11 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.933
72626073|NCT00402987|144781728|SUPERIORITY_OR_OTHER_LEGACY|||||||0.876||95.0||||"Analysis at 12 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.876
72626074|NCT00402987|144781728|SUPERIORITY_OR_OTHER_LEGACY|||||||0.622||95.0||||"Analysis at 24 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.622
72626075|NCT00402987|144781728|SUPERIORITY_OR_OTHER_LEGACY|||||||0.081||95.0||||"Analysis at 7 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.081
72626076|NCT00402987|144781728|SUPERIORITY_OR_OTHER_LEGACY|||||||0.117||95.0||||"Analysis at 8 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.117
72626077|NCT00402987|144781728|SUPERIORITY_OR_OTHER_LEGACY|||||||0.152||95.0||||"Analysis at 9 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.152
72626078|NCT00402987|144781728|SUPERIORITY_OR_OTHER_LEGACY|||||||0.171||95.0||||"Analysis at 10 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.171
72626079|NCT00402987|144781728|SUPERIORITY_OR_OTHER_LEGACY|||||||0.197||95.0||||"Analysis at 11 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.197
72532083|NCT04516291|144593328|OTHER||LS Mean difference|-56.8|STANDARD_ERROR_OF_MEAN|6.14|<|0.001|TWO_SIDED|95.0|-68.9|-44.7|||Mixed Models Analysis|MMRM with baseline value, treatment, visit, interaction term of treatment by visit as fixed effects and unstructured covariance structure was used.||TG||-44.7|-68.9|<0.001
72532084|NCT04516291|144593328|OTHER||LS Mean difference|-15.1|STANDARD_ERROR_OF_MEAN|4.36|<|0.001|TWO_SIDED|95.0|-23.7|-6.5|||Mixed Models Analysis|MMRM with baseline value, treatment, visit, interaction term of treatment by visit as fixed effects and unstructured covariance structure was used.||ApoB||-6.5|-23.7|<0.001
72532085|NCT04516291|144593328|OTHER||LS Mean difference|-10.6|STANDARD_ERROR_OF_MEAN|4.34||0.015|TWO_SIDED|95.0|-19.2|-2.1|||Mixed Models Analysis|MMRM with baseline value, treatment, visit, interaction term of treatment by visit as fixed effects and unstructured covariance structure was used.||ApoB||-2.1|-19.2|0.015
72532086|NCT04516291|144593328|OTHER||LS Mean difference|-11.5|STANDARD_ERROR_OF_MEAN|4.49||0.011|TWO_SIDED|95.0|-20.3|-2.7|||Mixed Models Analysis|MMRM with baseline value, treatment, visit, interaction term of treatment by visit as fixed effects and unstructured covariance structure was used.||ApoB||-2.7|-20.3|0.011
72572223|NCT02912650|144671814|SUPERIORITY_OR_OTHER||CMH adjusted proportions|15.12|||<|0.001|TWO_SIDED|95.0|6.55|23.69|||Cochran-Mantel-Haenszel|||10 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||23.69|6.55|<0.001
72572224|NCT02912650|144671814|SUPERIORITY_OR_OTHER||CMH adjusted proportions|50.74|||<|0.001|TWO_SIDED|95.0|37.39|64.09|||Cochran-Mantel-Haenszel|||10 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||64.09|37.39|<0.001
72572225|NCT02912650|144671814|SUPERIORITY_OR_OTHER||CMH adjusted proportions|43.16|||<|0.001||95.0|29.56|56.75|||Cochran-Mantel-Haenszel|||10 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||56.75|29.56|<0.001
72572226|NCT02912650|144671814|SUPERIORITY_OR_OTHER||CMH adjusted proportions|7.91||||0.087|TWO_SIDED|95.0|-1.15|16.97|||Cochran-Mantel-Haenszel|||10 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||16.97|-1.15|0.087
72626080|NCT00402987|144781728|SUPERIORITY_OR_OTHER_LEGACY|||||||0.244||95.0||||"Analysis at 12 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.244
72532087|NCT04516291|144593328|OTHER||LS Mean difference|-12.5|STANDARD_ERROR_OF_MEAN|3.64|<|0.001|TWO_SIDED|95.0|-19.7|-5.3|||Mixed Models Analysis|MMRM with baseline value, treatment, visit, interaction term of treatment by visit as fixed effects and unstructured covariance structure was used.||ApoB||-5.3|-19.7|<0.001
72532088|NCT04516291|144593328|OTHER||LS Mean difference|-12.6|STANDARD_ERROR_OF_MEAN|3.54|<|0.001|TWO_SIDED|95.0|-19.5|-5.6|||Mixed Models Analysis|MMRM with baseline value, treatment, visit, interaction term of treatment by visit as fixed effects and unstructured covariance structure was used.||ApoB||-5.6|-19.5|<0.001
72532089|NCT04516291|144593328|OTHER||LS Mean difference|-6.0|STANDARD_ERROR_OF_MEAN|3.56||0.095|TWO_SIDED|95.0|-13.0|1.0|||Mixed Models Analysis|MMRM with baseline value, treatment, visit, interaction term of treatment by visit as fixed effects and unstructured covariance structure was used.||ApoB||1.0|-13.0|0.095
72532090|NCT04516291|144593328|OTHER||LS Mean difference|-8.5|STANDARD_ERROR_OF_MEAN|4.01||0.036|TWO_SIDED|95.0|-16.4|-0.6|||Mixed Models Analysis|MMRM with baseline value, treatment, visit, interaction term of treatment by visit as fixed effects and unstructured covariance structure was used.||ApoB||-0.6|-16.4|0.036
72572227|NCT02912650|144671814|SUPERIORITY_OR_OTHER||CMH adjusted proportions|58.12|||<|0.001|TWO_SIDED|95.0|45.24|71.0|||Cochran-Mantel-Haenszel|||11 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||71.00|45.24|<0.001
72572228|NCT02912650|144671814|SUPERIORITY_OR_OTHER||CMH adjusted proportions|7.23||||0.071||95.0|-0.63|15.1|||Cochran-Mantel-Haenszel|||11 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||15.10|-0.63|0.071
72572229|NCT02912650|144671814|SUPERIORITY_OR_OTHER||CMH adjusted proportions|15.12|||<|0.001||95.0|6.55|23.69|||Cochran-Mantel-Haenszel|||11 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||23.69|6.55|<0.001
72572230|NCT02912650|144671814|SUPERIORITY_OR_OTHER||CMH adjusted proportions|50.74|||<|0.001||95.0|37.39|64.09|||Cochran-Mantel-Haenszel|||11 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||64.09|37.39|<0.001
72572231|NCT02912650|144671814|SUPERIORITY_OR_OTHER||CMH adjusted proportions|43.16|||<|0.001|TWO_SIDED|95.0|29.56|56.75|||Cochran-Mantel-Haenszel|||11 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||56.75|29.56|<0.001
72572232|NCT02912650|144671814|SUPERIORITY_OR_OTHER||CMH adjusted proportions|7.91||||0.087|TWO_SIDED|95.0|-1.15|16.97|||Cochran-Mantel-Haenszel|||11 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||16.97|-1.15|0.087
72572233|NCT02912650|144671814|SUPERIORITY_OR_OTHER||CMH adjusted proportions|58.12|||<|0.001|TWO_SIDED|95.0|45.24|71.0|||Cochran-Mantel-Haenszel|||12 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||71.00|45.24|<0.001
72626081|NCT00402987|144781728|SUPERIORITY_OR_OTHER_LEGACY|||||||0.708||95.0||||"Analysis at 24 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.708
72532091|NCT04516291|144593328|OTHER||LS Mean difference|-10.0|STANDARD_ERROR_OF_MEAN|6.55||0.129|TWO_SIDED|95.0|-22.9|2.9|||Mixed Models Analysis|MMRM with baseline value, treatment, visit, interaction term of treatment by visit as fixed effects and unstructured covariance structure was used.||LDL-C||2.9|-22.9|0.129
72532092|NCT04516291|144593328|OTHER||LS Mean difference|-7.9|STANDARD_ERROR_OF_MEAN|6.65||0.238|TWO_SIDED|95.0|-21.0|5.2|||Mixed Models Analysis|MMRM with baseline value, treatment, visit, interaction term of treatment by visit as fixed effects and unstructured covariance structure was used.||LDL-C||5.2|-21.0|0.238
72532093|NCT04516291|144593328|OTHER||LS Mean difference|-11.4|STANDARD_ERROR_OF_MEAN|6.73||0.09|TWO_SIDED|95.0|-24.7|1.8|||Mixed Models Analysis|MMRM with baseline value, treatment, visit, interaction term of treatment by visit as fixed effects and unstructured covariance structure was used.||LDL-C||1.8|-24.7|0.090
72532094|NCT04516291|144593328|OTHER||LS Mean difference|-16.0|STANDARD_ERROR_OF_MEAN|5.44||0.004|TWO_SIDED|95.0|-26.7|-5.3|||Mixed Models Analysis|MMRM with baseline value, treatment, visit, interaction term of treatment by visit as fixed effects and unstructured covariance structure was used.||LDL-C||-5.3|-26.7|0.004
72532095|NCT04516291|144593328|OTHER||LS Mean difference|-14.5|STANDARD_ERROR_OF_MEAN|5.38||0.008|TWO_SIDED|95.0|-25.1|-3.9|||Mixed Models Analysis|MMRM with baseline value, treatment, visit, interaction term of treatment by visit as fixed effects and unstructured covariance structure was used.||LDL-C||-3.9|-25.1|0.008
72532096|NCT04516291|144593328|OTHER||LS Mean difference|-7.9|STANDARD_ERROR_OF_MEAN|5.28||0.136|TWO_SIDED|95.0|-18.3|2.5|||Mixed Models Analysis|MMRM with baseline value, treatment, visit, interaction term of treatment by visit as fixed effects and unstructured covariance structure was used.||LDL-C||2.5|-18.3|0.136
72532097|NCT04516291|144593328|OTHER||LS Mean difference|-9.0|STANDARD_ERROR_OF_MEAN|6.01||0.138|TWO_SIDED|95.0|-20.8|2.9|||Mixed Models Analysis|MMRM with baseline value, treatment, visit, interaction term of treatment by visit as fixed effects and unstructured covariance structure was used.||LDL-C||2.9|-20.8|0.138
72532098|NCT04516291|144593330|OTHER||LS Mean difference|-69.9|STANDARD_ERROR_OF_MEAN|5.97|<|0.001|TWO_SIDED|95.0|-81.6|-58.1|||Mixed Models Analysis|MMRM with baseline value, treatment, visit, interaction term of treatment by visit as fixed effects and unstructured covariance structure was used.||||-58.1|-81.6|<0.001
72532099|NCT04516291|144593330|OTHER||LS Mean difference|-79.6|STANDARD_ERROR_OF_MEAN|6.03|<|0.001|TWO_SIDED|95.0|-91.5|-67.7|||Mixed Models Analysis|MMRM with baseline value, treatment, visit, interaction term of treatment by visit as fixed effects and unstructured covariance structure was used.||||-67.7|-91.5|<0.001
72532100|NCT04516291|144593330|OTHER||LS Mean difference|-77.1|STANDARD_ERROR_OF_MEAN|6.22|<|0.001|TWO_SIDED|95.0|-89.4|-64.9|||Mixed Models Analysis|MMRM with baseline value, treatment, visit, interaction term of treatment by visit as fixed effects and unstructured covariance structure was used.||||-64.9|-89.4|<0.001
72532101|NCT04516291|144593330|OTHER||LS Mean difference|-86.3|STANDARD_ERROR_OF_MEAN|5.04|<|0.001|TWO_SIDED|95.0|-96.2|-76.3|||Mixed Models Analysis|MMRM with baseline value, treatment, visit, interaction term of treatment by visit as fixed effects and unstructured covariance structure was used.||||-76.3|-96.2|<0.001
72532102|NCT04516291|144593330|OTHER||LS Mean difference|-80.4|STANDARD_ERROR_OF_MEAN|4.82|<|0.001|TWO_SIDED|95.0|-89.9|-70.9|||Mixed Models Analysis|MMRM with baseline value, treatment, visit, interaction term of treatment by visit as fixed effects and unstructured covariance structure was used.||||-70.9|-89.9|<0.001
72532103|NCT04516291|144593330|OTHER||LS Mean difference|-92.2|STANDARD_ERROR_OF_MEAN|4.92|<|0.001|TWO_SIDED|95.0|-101.9|-82.6|||Mixed Models Analysis|MMRM with baseline value, treatment, visit, interaction term of treatment by visit as fixed effects and unstructured covariance structure was used.||||-82.6|-101.9|<0.001
72532104|NCT04516291|144593330|OTHER||LS Mean difference|-95.2|STANDARD_ERROR_OF_MEAN|5.59|<|0.001|TWO_SIDED|95.0|-106.2|-84.2|||Mixed Models Analysis|MMRM with baseline value, treatment, visit, interaction term of treatment by visit as fixed effects and unstructured covariance structure was used.||||-84.2|-106.2|<0.001
72532105|NCT02322866|144593340|SUPERIORITY||Least Squares Mean Difference|-4.4|||<|0.0001|TWO_SIDED|95.0|-5.8|-2.9||Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.|ANCOVA||sarecycline - placebo|||-2.9|-5.8|< 0.0001
72532106|NCT02322866|144593341|SUPERIORITY||Treatment Rate Difference|7.3||||0.0038|TWO_SIDED|95.0|2.53|12.07||P-values were based on the test of general association between the response and treatment group using Cochran-Mantel-Haenszel test with pooled site as stratification factor.|Cochran-Mantel-Haenszel||sarecycline - placebo|||12.07|2.53|0.0038
72532107|NCT02322866|144593342|SUPERIORITY||Least Squares Mean Difference|-14.4|||<|0.0001|TWO_SIDED|95.0|-19.4|-9.5||Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.|ANCOVA||sarecycline - placebo|Percent Change from Baseline to Week 12||-9.5|-19.4|< 0.0001
72532108|NCT02322866|144593343|SUPERIORITY||Least Squares Mean Difference|-12.6|||<|0.0001|TWO_SIDED|95.0|-17.3|-7.9||Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.|ANCOVA||sarecycline - placebo|Percent Change from Baseline to Week 9||-7.9|-17.3|< 0.0001
72532109|NCT02322866|144593344|SUPERIORITY||Least Squares Mean Difference|-11.8|||<|0.0001|TWO_SIDED|95.0|-16.1|-7.5||Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.|ANCOVA||sarecycline - placebo|Percent Change from Baseline to Week 6||-7.5|-16.1|< 0.0001
72532110|NCT02322866|144593345|SUPERIORITY||Least Squares Mean Difference|-9.4|||<|0.0001|TWO_SIDED|95.0|-13.5|-5.3||Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.|ANCOVA||sarecycline - placebo|Percent Change from Baseline to Week 3||-5.3|-13.5|< 0.0001
72532111|NCT02322866|144593346|SUPERIORITY||Least Squares Mean Difference|-3.8|||<|0.0001|TWO_SIDED|95.0|-5.2|-2.5||Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.|ANCOVA||sarecycline - placebo|Change from Baseline to Week 9||-2.5|-5.2|< 0.0001
72532112|NCT02322866|144593347|SUPERIORITY||Least Squares Mean Difference|-3.7|||<|0.0001|TWO_SIDED|95.0|-5.0|-2.4||Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.|ANCOVA||sarecycline - placebo|Change from Baseline to Week 6||-2.4|-5.0|< 0.0001
72572234|NCT02912650|144671814|SUPERIORITY_OR_OTHER||CMH adjusted proportions|7.23||||0.071|TWO_SIDED|95.0|-0.63|15.1|||Cochran-Mantel-Haenszel|||12 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||15.10|-0.63|0.071
72572235|NCT02912650|144671814|SUPERIORITY_OR_OTHER||CMH adjusted proportions|15.12|||<|0.001|TWO_SIDED|95.0|6.55|23.69|||Cochran-Mantel-Haenszel|||12 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||23.69|6.55|<0.001
72572236|NCT02912650|144671814|SUPERIORITY_OR_OTHER||CMH adjusted proportions|50.74|||<|0.001|TWO_SIDED|95.0|37.39|64.09|||Cochran-Mantel-Haenszel|||12 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||64.09|37.39|<0.001
72572237|NCT02912650|144671814|SUPERIORITY_OR_OTHER||CMH adjusted proportions|43.16|||<|0.001|TWO_SIDED|95.0|29.56|56.75|||Cochran-Mantel-Haenszel|||12 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||56.75|29.56|<0.001
72572238|NCT02912650|144671814|SUPERIORITY_OR_OTHER||CMH adjusted proportions|7.91||||0.087|TWO_SIDED|95.0|-1.15|16.97|||Cochran-Mantel-Haenszel|||12 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||16.97|-1.15|0.087
72626082|NCT00402987|144781728|SUPERIORITY_OR_OTHER_LEGACY|||||||0.106||95.0||||"Analysis at 7 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.106
72626083|NCT00402987|144781728|SUPERIORITY_OR_OTHER_LEGACY|||||||0.14||95.0||||"Analysis at 8 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.140
72572239|NCT02912650|144671815|SUPERIORITY_OR_OTHER||CMH adjusted proportions|1.16||||0.156|TWO_SIDED|95.0|-0.44|2.75|||Cochran-Mantel-Haenszel|||0.25 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||2.75|-0.44|0.156
72572240|NCT02912650|144671815|SUPERIORITY_OR_OTHER||CMH adjusted proportions|1.16||||0.155|TWO_SIDED|95.0|-0.44|2.76|||Cochran-Mantel-Haenszel|||0.25 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||2.76|-0.44|0.155
72572241|NCT02912650|144671815|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-0.68||||0.605|TWO_SIDED|95.0|-3.27|1.9|||Cochran-Mantel-Haenszel|||0.25 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||1.90|-3.27|0.605
72572242|NCT02912650|144671815|SUPERIORITY_OR_OTHER||CMH adjusted proportions|1.84||||0.079|TWO_SIDED|95.0|-0.21|3.89|||Cochran-Mantel-Haenszel|||0.25 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||3.89|-0.21|0.079
72572243|NCT02912650|144671815|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-1.85||||0.078|TWO_SIDED|95.0|-3.9|0.21|||Cochran-Mantel-Haenszel|||0.25 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||0.21|-3.90|0.078
72572244|NCT02912650|144671815|SUPERIORITY_OR_OTHER||CMH adjusted proportions|21.47|||<|0.001|TWO_SIDED|95.0|15.33|27.62|||Cochran-Mantel-Haenszel|||0.5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||27.62|15.33|<0.001
72572245|NCT02912650|144671815|SUPERIORITY_OR_OTHER||Cumulative Percentage of Participants wi|7.79||||0.056|TWO_SIDED|95.0|-0.19|15.77|||Cochran-Mantel-Haenszel|||0.5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||15.77|-0.19|0.056
72572246|NCT02912650|144671815|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-0.37||||0.934|TWO_SIDED|95.0|-9.18|8.43|||Cochran-Mantel-Haenszel|||0.5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||8.43|-9.18|0.934
72572247|NCT02912650|144671815|SUPERIORITY_OR_OTHER||CMH adjusted proportions|13.67|||<|0.001|TWO_SIDED|95.0|8.58|18.77|||Cochran-Mantel-Haenszel|||0.5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||18.77|8.58|<0.001
72572248|NCT02912650|144671815|SUPERIORITY_OR_OTHER||CMH adjusted proportions|21.96|||<|0.001|TWO_SIDED|95.0|15.64|28.28|||Cochran-Mantel-Haenszel|||0.5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||28.28|15.64|<0.001
72626084|NCT00402987|144781728|SUPERIORITY_OR_OTHER_LEGACY|||||||0.188||95.0||||"Analysis at 9 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.188
72626085|NCT00402987|144781728|SUPERIORITY_OR_OTHER_LEGACY|||||||0.239||95.0||||"Analysis at 10 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.239
72626086|NCT00402987|144781728|SUPERIORITY_OR_OTHER_LEGACY|||||||0.297||95.0||||"Analysis at 11 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.297
72626087|NCT00402987|144781728|SUPERIORITY_OR_OTHER_LEGACY|||||||0.383||95.0||||"Analysis at 12 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.383
72626088|NCT00402987|144781728|SUPERIORITY_OR_OTHER_LEGACY|||||||0.919||95.0||||"Analysis at 24 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.919
72626089|NCT00402987|144781728|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 11 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
72626090|NCT00402987|144781729|SUPERIORITY_OR_OTHER_LEGACY|||||||0.537||95.0||||"Analysis at 15 min~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.537
72626091|NCT00402987|144781729|SUPERIORITY_OR_OTHER_LEGACY|||||||0.697||95.0||||"Analysis at 30 min~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.697
72626092|NCT00402987|144781729|SUPERIORITY_OR_OTHER_LEGACY|||||||0.203||95.0||||"Analysis at 45 min~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.203
72626093|NCT00402987|144781729|SUPERIORITY_OR_OTHER_LEGACY|||||||0.003||95.0||||"Analysis at 60 min~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.003
72626094|NCT00402987|144781729|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 75 min~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
72626095|NCT00402987|144781729|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 90 min~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
72532113|NCT02322866|144593348|SUPERIORITY||Least Squares Mean Difference|-2.9|||<|0.0001|TWO_SIDED|95.0|-4.1|-1.7||Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.|ANCOVA||sarecycline - placebo|Change from Baseline to Week 3||-1.7|-4.1|< 0.0001
72532114|NCT02181634|144593360|SUPERIORITY||Hazard Ratio (HR)|2.02||||0.099|TWO_SIDED|95.0|0.86|4.75|||Log Rank|||||4.75|0.86|0.099
72532115|NCT02181634|144593361|SUPERIORITY||Hazard Ratio (HR)|1.54||||0.34|TWO_SIDED|95.0|0.64|3.71|||Log Rank|||||3.71|0.64|0.34
72532116|NCT02145949|144593368|OTHER|||||||0.03|||||||ANCOVA|||||||.03
72532117|NCT02145949|144593369|OTHER|||||||0.01|||||||ANCOVA|||||||.01
72532118|NCT02145949|144593370|OTHER|||||||0.04|||||||ANCOVA|||||||.04
72626096|NCT00402987|144781729|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 1.75 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
72626097|NCT00402987|144781729|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 2 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
72626098|NCT00402987|144781729|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 3 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
72626099|NCT00402987|144781729|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 4 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
72626100|NCT00402987|144781729|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 5 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
72626101|NCT00402987|144781729|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 6 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
72626102|NCT00402987|144781730|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001||95.0||||"Analysis at 7 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.001
72626103|NCT00402987|144781730|SUPERIORITY_OR_OTHER_LEGACY|||||||0.005||95.0||||"Analysis at 8 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.005
72626104|NCT00402987|144781730|SUPERIORITY_OR_OTHER_LEGACY|||||||0.046||95.0||||"Analysis at 9 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.046
72626105|NCT00402987|144781730|SUPERIORITY_OR_OTHER_LEGACY|||||||0.046||95.0||||"Analysis at 10 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.046
72626106|NCT00402987|144781730|SUPERIORITY_OR_OTHER_LEGACY|||||||0.111||95.0||||"Analysis at 11 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.111
72626107|NCT00402987|144781730|SUPERIORITY_OR_OTHER_LEGACY|||||||0.226||95.0||||"Analysis at 12 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.226
72626108|NCT00402987|144781730|SUPERIORITY_OR_OTHER_LEGACY|||||||0.537||95.0||||"Analysis at 24 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.537
72532119|NCT02145949|144593371|OTHER|||||||0.01|||||||ANCOVA|||||||.01
72532120|NCT02145949|144593372|OTHER|||||||0.12|||||||ANCOVA|||||||.12
72532121|NCT02145949|144593373|OTHER|||||||0.03|||||||ANCOVA|||||||.03
72532122|NCT02145949|144593374|OTHER|||||||0.71|||||||ANCOVA|||||||.71
72626109|NCT00402987|144781731|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.64||||0.01||95.0|1.3|5.5||Treatment as a factor|Regression, Logistic|||||5.5|1.3|0.010
72626110|NCT00402987|144781731|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|3.07||||0.003||95.0|1.5|6.4||Treatment as a factor|Regression, Logistic|||||6.4|1.5|0.003
72626111|NCT00402987|144781731|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.16||||0.634||95.0|0.6|2.2||Treatment as a factor|Regression, Logistic|||||2.2|0.6|0.634
72626112|NCT00402987|144781732|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.63||||0.202||95.0|0.8|3.5||Treatment as a factor|Regression, Logistic|||||3.5|0.8|0.202
72626113|NCT00402987|144781732|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.18||||0.077||95.0|0.9|5.1||Treatment as a factor|Regression, Logistic|||||5.1|0.9|0.077
72626114|NCT00402987|144781732|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.95||||0.134||95.0|0.8|4.7||Treatment as a factor|Regression, Logistic|||||4.7|0.8|0.134
72626115|NCT00402987|144781732|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.84||||0.671||95.0|0.4|1.9||Treatment as a factor|Regression, Logistic|||||1.9|0.4|0.671
72532123|NCT02145949|144593375|OTHER|||||||0.76|||||||ANCOVA|||||||.76
72532124|NCT02145949|144593376|OTHER|||||||0.4|||||||ANCOVA|||||||.40
72532125|NCT02145949|144593377|OTHER|||||||0.97|||||||ANCOVA|||||||.97
72532126|NCT02145949|144593378|OTHER|||||||0.89|||||||ANCOVA|||||||.89
72532127|NCT02145949|144593379|OTHER|||||||0.48|||||||ANCOVA|||||||.48
72532128|NCT02145949|144593380|OTHER|||||||0.02|||||||ANCOVA|||||||.02
72532129|NCT02145949|144593381|OTHER|||||||0.29|||||||ANCOVA|||||||.29
72532130|NCT02145949|144593382|OTHER|||||||0.33|||||||ANCOVA|||||||.33
72532131|NCT02145949|144593383|OTHER|||||||0.3|||||||ANCOVA|||||||.30
72532132|NCT02145949|144593384|OTHER|||||||0.98|||||||ANCOVA|||||||.98
72532133|NCT02145949|144593385|OTHER|||||||0.18|||||||ANCOVA|||||||.18
72532134|NCT02145949|144593386|OTHER|||||||0.52|||||||ANCOVA|||||||.52
72532135|NCT02145949|144593387|OTHER|||||||0.81|||||||ANCOVA|||||||.81
72532136|NCT02843282|144593394|SUPERIORITY||Mean Difference (Net)|0.69||||0.04|TWO_SIDED||||||Regression, Linear|||||||0.040
72532137|NCT02843282|144593395|SUPERIORITY||Mean Difference (Net)|0.98||||0.004|TWO_SIDED||||||Regression, Linear|||||||0.004
72532138|NCT02843282|144593396|SUPERIORITY||Mean Difference (Net)|1.95|||<|0.001|TWO_SIDED||||||Regression, Linear|||||||<0.001
72532139|NCT02843282|144593397|SUPERIORITY||Mean Difference (Net)|0.52||||0.039|TWO_SIDED||||||Regression, Linear|||||||0.039
72532140|NCT02843282|144593398|SUPERIORITY||Mean Difference (Net)|0.42||||0.092|TWO_SIDED||||||Regression, Linear|||||||0.092
72532141|NCT02843282|144593399|SUPERIORITY||Mean Difference (Net)|6.58||||0.052|TWO_SIDED||||||Regression, Linear|||||||0.052
72532142|NCT02843282|144593400|SUPERIORITY||Mean Difference (Net)|0.52||||0.121|TWO_SIDED||||||Regression, Linear|||||||0.121
72532143|NCT02843282|144593401|SUPERIORITY||Mean Difference (Net)|1.23||||0.019|TWO_SIDED||||||Regression, Linear|||||||0.019
72532144|NCT02843282|144593402|SUPERIORITY||Mean Difference (Net)|0.37||||0.278|TWO_SIDED||||||Regression, Linear|||||||0.278
72626116|NCT00402987|144781732|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.75||||0.484||95.0|0.3|1.7||Treatment as a factor|Regression, Logistic|||||1.7|0.3|0.484
72626117|NCT00402987|144781732|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.12||||0.814||95.0|0.4|2.8||Treatment as a factor|Regression, Logistic|||||2.8|0.4|0.814
72626118|NCT00402987|144781733|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05||95.0||||p-value for distribution of time to perceptible pain relief|Log Rank|||For subjects who did not experience perceptible pain relief within 2 hours post-first dose, the time to perceptible pain relief was censored at 2 hours||||<0.05
72626119|NCT00402987|144781733|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05||95.0||||p-value for distribution of time to perceptible pain relief|Log Rank|||For subjects who did not experience perceptible pain relief within 2 hours post-first dose, the time to perceptible pain relief was censored at 2 hours||||<0.05
72626120|NCT00402987|144781733|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05||95.0||||p-value for distribution of time to perceptible pain relief|Log Rank|||For subjects who did not experience perceptible pain relief within 2 hours post-first dose, the time to perceptible pain relief was censored at 2 hours||||<0.05
72626121|NCT00402987|144781734|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05||95.0||||p-value for distribution of time to meaningful pain relief|Log Rank|||For subjects who did not experience meaningful pain relief within 2 hours post-first dose, the time to meaningful pain relief was censored at 2 hours.||||<0.05
72532145|NCT02843282|144593403|SUPERIORITY||Mean Difference (Net)|7.0||||0.095|TWO_SIDED||||||Regression, Linear|||||||0.095
72532146|NCT02843282|144593404|OTHER||Mean Difference (Net)|0.15|||<|0.01|TWO_SIDED||||||Whole brain voxel-wise correlation analy|||||||< 0.01
72532147|NCT02843282|144593405|SUPERIORITY||Mean Difference (Net)|1.22||||0.001|TWO_SIDED||||||Regression, Linear|||||||0.001
72532148|NCT02843282|144593406|SUPERIORITY||Mean Difference (Net)|1.33||||0.007|TWO_SIDED||||||Regression, Linear|||||||0.007
72532149|NCT04550234|144593407|OTHER||Geometric mean ratio|57.73|||||TWO_SIDED|90.0|47.07|70.81||||||"Statistical Comparison of Verinurad~Analysis of variance (ANOVA) of log transformed PK parameter with treatment, sequence, period as fixed effects and subject nested within sequence as random effect"||70.81|47.07|
72532150|NCT04550234|144593407|OTHER||Geometric mean ratio|145.55|||||TWO_SIDED|90.0|118.66|178.52||||||"Statistical Comparison of Verinurad~Analysis of variance (ANOVA) of log transformed PK parameter with treatment, sequence, period as fixed effects and subject nested within sequence as random effect"||178.52|118.66|
72532151|NCT04550234|144593407|OTHER||Geometric mean ratio|52.07|||||TWO_SIDED|90.0|42.46|63.87||||||"Statistical Comparison of Verinurad~Analysis of variance (ANOVA) of log transformed PK parameter with treatment, sequence, period as fixed effects and subject nested within sequence as random effect"||63.87|42.46|
72532152|NCT04550234|144593407|OTHER||Geometric mean ratio|101.16|||||TWO_SIDED|90.0|82.48|124.08||||||"Statistical Comparison of Verinurad~Analysis of variance (ANOVA) of log transformed PK parameter with treatment, sequence, period as fixed effects and subject nested within sequence as random effect"||124.08|82.48|
72626122|NCT00402987|144781734|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05||95.0||||p-value for distribution of time to meaningful pain relief|Log Rank|||For subjects who did not experience meaningful pain relief within 2 hours post-first dose, the time to meaningful pain relief was censored at 2 hours||||<0.05
72626123|NCT00402987|144781735|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05||95.0||||p-value for distribution of time to onset of analgesia|Log Rank|||For subjects who did not experience onset of analgesia within 2 hours post-first dose, the time to onset of analgesia was censored at 2 hours||||<0.05
72626124|NCT00402987|144781735|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05||95.0||||p-value for distribution of time to onset of analgesia|Log Rank|||For subjects who did not experience onset of analgesia within 2 hours post-first dose, the time to onset of analgesia was censored at 2 hours||||<0.05
72626125|NCT00402987|144781736|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||Overall test of Celecoxib 50mg/50mg versus Placebo that takes into account the ordered data (categories: excellent, good, fair, poor).|Mantel Haenszel|Test of row mean score differences based on modified ridits (standardizing the mid-rank)||||||<0.001
72626126|NCT00402987|144781736|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||Overall test of Celecoxib 100mg (pooled) versus Placebo that takes into account the ordered data (categories: excellent, good, fair, poor).|Mantel Haenszel|Test of row mean score differences based on modified ridits (standardizing the mid-rank)||||||<0.001
72369205|NCT00611026|144248555|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED||||||Van Elteren's Test|P-value based on Van Elteren's Test (a stratified Wilcoxon-Mann Whitney test) adjusted by baseline quartile of voided volume.||"Treatment difference fesoterodine vs placebo at Week 1. Treatment effects estimated by Winsorized means (5% of the tails were censored, ie, replaced with the value at the 5th and 95th percentile, respectively).~If normality assumptions were severely violated (proportion of non normal observations \> 5%) a non-parametric analysis was to be conducted using Van Elteren's test stratified by baseline quartile of the diary variable analyzed."||||0.0020
72532153|NCT04550234|144593407|OTHER||Geometric mean ratio|73.34|||||TWO_SIDED|90.0|61.81|87.03||||||"Statistical Comparison of Allopurinol~Analysis of variance (ANOVA) of log transformed PK parameter with treatment, sequence, period as fixed effects and subject nested within sequence as random effect"||87.03|61.81|
72532154|NCT04550234|144593407|OTHER||Geometric mean ratio|66.33|||||TWO_SIDED|90.0|55.9|78.72||||||"Statistical Comparison of Allopurinol~Analysis of variance (ANOVA) of log transformed PK parameter with treatment, sequence, period as fixed effects and subject nested within sequence as random effect"||78.72|55.90|
72532155|NCT04550234|144593407|OTHER||Geometric mean ratio|106.58|||||TWO_SIDED|90.0|89.81|126.47||||||"Statistical Comparison of Allopurinol~Analysis of variance (ANOVA) of log transformed PK parameter with treatment, sequence, period as fixed effects and subject nested within sequence as random effect"||126.47|89.81|
72532156|NCT04550234|144593407|OTHER||Geometric mean ratio|86.86|||||TWO_SIDED|90.0|83.15|90.74||||||"Statistical Comparison of Oxypurinol~Analysis of variance (ANOVA) of log transformed PK parameter with treatment, sequence, period as fixed effects and subject nested within sequence as random effect"||90.74|83.15|
72532157|NCT04550234|144593407|OTHER||Geometric mean ratio|92.3|||||TWO_SIDED|90.0|88.35|96.42||||||"Statistical Comparison of Oxypurinol~Analysis of variance (ANOVA) of log transformed PK parameter with treatment, sequence, period as fixed effects and subject nested within sequence as random effect"||96.42|88.35|
72532158|NCT04550234|144593407|OTHER||Geometric mean ratio|89.54|||||TWO_SIDED|90.0|85.71|93.54||||||"Statistical Comparison of Oxypurinol~Analysis of variance (ANOVA) of log transformed PK parameter with treatment, sequence, period as fixed effects and subject nested within sequence as random effect"||93.54|85.71|
72532159|NCT04550234|144593408|OTHER||Geometric mean ratio|102.49|||||TWO_SIDED|90.0|89.12|117.86||||||"Statistical Comparison of Verinurad~Analysis of variance (ANOVA) of log transformed PK parameter with treatment, sequence, period as fixed effects and subject nested within sequence as random effect"||117.86|89.12|
72532160|NCT04550234|144593408|OTHER||Geometric mean ratio|144.61|||||TWO_SIDED|90.0|125.75|166.31||||||"Statistical Comparison of Verinurad~Analysis of variance (ANOVA) of log transformed PK parameter with treatment, sequence, period as fixed effects and subject nested within sequence as random effect"||166.31|125.75|
72532161|NCT04550234|144593408|OTHER||Geometric mean ratio|76.72|||||TWO_SIDED|90.0|66.71|88.23||||||"Statistical Comparison of Verinurad~Analysis of variance (ANOVA) of log transformed PK parameter with treatment, sequence, period as fixed effects and subject nested within sequence as random effect"||88.23|66.71|
72532162|NCT04550234|144593408|OTHER||Geometric mean ratio|96.19|||||TWO_SIDED|90.0|83.64|110.62||||||"Statistical Comparison of Verinurad~Analysis of variance (ANOVA) of log transformed PK parameter with treatment, sequence, period as fixed effects and subject nested within sequence as random effect"||110.62|83.64|
72532163|NCT04550234|144593408|OTHER||Geometric mean ratio|89.41|||||TWO_SIDED|90.0|83.86|95.34||||||"Statistical Comparison of Allopurinol~Analysis of variance (ANOVA) of log transformed PK parameter with treatment, sequence, period as fixed effects and subject nested within sequence as random effect"||95.34|83.86|
72532164|NCT04550234|144593408|OTHER||Geometric mean ratio|94.16|||||TWO_SIDED|90.0|88.31|100.4||||||"Statistical Comparison of Allopurinol~Analysis of variance (ANOVA) of log transformed PK parameter with treatment, sequence, period as fixed effects and subject nested within sequence as random effect"||100.40|88.31|
72532165|NCT04550234|144593408|OTHER||Geometric mean ratio|91.7|||||TWO_SIDED|90.0|86.37|97.36||||||"Statistical Comparison of Allopurinol~Analysis of variance (ANOVA) of log transformed PK parameter with treatment, sequence, period as fixed effects and subject nested within sequence as random effect"||97.36|86.37|
72532166|NCT04550234|144593408|OTHER||Geometric mean ratio|91.23|||||TWO_SIDED|90.0|88.01|94.56||||||"Statistical Comparison of Oxypurinol~Analysis of variance (ANOVA) of log transformed PK parameter with treatment, sequence, period as fixed effects and subject nested within sequence as random effect"||94.56|88.01|
72532167|NCT04550234|144593408|OTHER||Geometric mean ratio|99.95|||||TWO_SIDED|90.0|96.43|103.61||||||"Statistical Comparison of Oxypurinol~Analysis of variance (ANOVA) of log transformed PK parameter with treatment, sequence, period as fixed effects and subject nested within sequence as random effect"||103.61|96.43|
72532168|NCT04550234|144593408|OTHER||Geometric mean ratio|90.13|||||TWO_SIDED|90.0|86.95|93.42||||||"Statistical Comparison of Oxypurinol~Analysis of variance (ANOVA) of log transformed PK parameter with treatment, sequence, period as fixed effects and subject nested within sequence as random effect"||93.42|86.95|
72626127|NCT00402987|144781736|SUPERIORITY_OR_OTHER_LEGACY|||||||0.889||95.0||||Overall test of Celecoxib 50mg/50mg versus Celecoxib 100mg (pooled) that takes into account the ordered data (categories: excellent, good, fair, poor).|Mantel Haenszel|Test of row mean score differences based on modified ridits (standardizing the mid-rank)||||||0.889
72626128|NCT00402987|144781737|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 12 hours~Overall test of Celecoxib 50mg/50mg versus Placebo that takes into account the ordered data (categories: excellent, good, fair, poor)."|Mantel Haenszel|Test of row mean score differences based on modified ridits (standardizing the mid-rank)||||||<0.001
72626129|NCT00402987|144781737|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002||95.0||||"Analysis at 12 hours~Overall test of Celecoxib 100mg/Placebo versus Placebo that takes into account the ordered data (categories: excellent, good, fair, poor)."|Mantel Haenszel|Test of row mean score differences based on modified ridits (standardizing the mid-rank)||||||0.002
72626130|NCT00402987|144781737|SUPERIORITY_OR_OTHER_LEGACY|||||||0.015||95.0||||Analysis at 12 hours Overall test of Celecoxib 100mg/50mg versus Placebo that takes into account the ordered data (categories: excellent, good, fair, poor).|Mantel Haenszel|Test of row mean score differences based on modified ridits (standardizing the mid-rank)||||||0.015
72626131|NCT00402987|144781737|SUPERIORITY_OR_OTHER_LEGACY|||||||0.411||95.0||||"Analysis at 12 hours~Overall test of Celecoxib 50mg/50mg versus Celecoxib 100mg/50mg that takes into account the ordered data (categories: excellent, good, fair, poor)."|Mantel Haenszel|Test of row mean score differences based on modified ridits (standardizing the mid-rank)||||||0.411
72626132|NCT00402987|144781737|SUPERIORITY_OR_OTHER_LEGACY|||||||0.93||95.0||||"Analysis at 12 hours~Overall test of Celecoxib 50mg/50mg versus Celecoxib 100mg/Placebo that takes into account the ordered data (categories: excellent, good, fair, poor)."|Mantel Haenszel|Test of row mean score differences based on modified ridits (standardizing the mid-rank)||||||0.930
72626133|NCT00402987|144781737|SUPERIORITY_OR_OTHER_LEGACY|||||||0.438||95.0||||"Analysis at 12 hours~Overall test of Celecoxib 100mg/Placebo versus Celecoxib 100mg/50mg that takes into account the ordered data (categories: excellent, good, fair, poor)."|Mantel Haenszel|Test of row mean score differences based on modified ridits (standardizing the mid-rank)||||||0.438
72626134|NCT00402987|144781737|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002||95.0||||"Analysis at 24 hours~Overall test of Celecoxib 50mg/50mg versus Placebo that takes into account the ordered data (categories: excellent, good, fair, poor)."|Mantel Haenszel|Test of row mean score differences based on modified ridits (standardizing the mid-rank)||||||0.002
72626135|NCT00402987|144781737|SUPERIORITY_OR_OTHER_LEGACY|||||||0.013||95.0||||"Analysis at 24 hours~Overall test of Celecoxib 100mg/Placebo versus Placebo that takes into account the ordered data (categories: excellent, good, fair, poor)."|Mantel Haenszel|Test of row mean score differences based on modified ridits (standardizing the mid-rank)||||||0.013
72626136|NCT00402987|144781737|SUPERIORITY_OR_OTHER_LEGACY|||||||0.015||95.0||||"Analysis at 24 hours~Overall test of Celecoxib 100mg/50mg versus Placebo that takes into account the ordered data (categories: excellent, good, fair, poor)."|Mantel Haenszel|Test of row mean score differences based on modified ridits (standardizing the mid-rank)||||||0.015
72626137|NCT00402987|144781737|SUPERIORITY_OR_OTHER_LEGACY|||||||0.748||95.0||||"Analysis at 24 hours~Overall test of Celecoxib 50mg/50mg versus Celecoxib 100mg/50mg that takes into account the ordered data (categories: excellent, good, fair, poor)."|Mantel Haenszel|Test of row mean score differences based on modified ridits (standardizing the mid-rank)||||||0.748
72532169|NCT04550234|144593409|OTHER||Geometric mean ratio|102.91|||||TWO_SIDED|90.0|89.04|118.93||||||"Statistical Comparison of Verinurad~Analysis of variance (ANOVA) of log transformed PK parameter with treatment, sequence, period as fixed effects and subject nested within sequence as random effect"||118.93|89.04|
72369206|NCT00611026|144248555|SUPERIORITY_OR_OTHER|||||||0.0519|TWO_SIDED||||||Van Elteren's Test|P-value based on Van Elteren's Test (a stratified Wilcoxon-Mann Whitney test) adjusted by baseline quartile of voided volume.||Treatment difference tolterodine ER vs placebo at Week 1. Treatment effects estimated by Winsorized means (5% of the tails were censored, ie, replaced with the value at the 5th and 95th percentile, respectively).||||0.0519
72532170|NCT04550234|144593409|OTHER||Geometric mean ratio|146.57|||||TWO_SIDED|90.0|126.82|169.4||||||"Statistical Comparison of Verinurad~Analysis of variance (ANOVA) of log transformed PK parameter with treatment, sequence, period as fixed effects and subject nested within sequence as random effect"||169.40|126.82|
72532171|NCT04550234|144593409|OTHER||Geometric mean ratio|76.72|||||TWO_SIDED|90.0|66.38|88.67||||||"Statistical Comparison of Verinurad~Analysis of variance (ANOVA) of log transformed PK parameter with treatment, sequence, period as fixed effects and subject nested within sequence as random effect"||88.67|66.38|
72532172|NCT04550234|144593409|OTHER||Geometric mean ratio|95.37|||||TWO_SIDED|90.0|82.52|110.23||||||"Statistical Comparison of Verinurad~Analysis of variance (ANOVA) of log transformed PK parameter with treatment, sequence, period as fixed effects and subject nested within sequence as random effect"||110.23|82.52|
72532173|NCT04550234|144593409|OTHER||Geometric mean ratio|82.6|||||TWO_SIDED|90.0|77.38|88.17||||||"Statistical Comparison of Allopurinol~Analysis of variance (ANOVA) of log transformed PK parameter with treatment, sequence, period as fixed effects and subject nested within sequence as random effect"||88.17|77.38|
72626138|NCT00402987|144781737|SUPERIORITY_OR_OTHER_LEGACY|||||||0.958||95.0||||"Analysis at 24 hours~Overall test of Celecoxib 50mg/50mg versus Celecoxib 100mg/Placebo that takes into account the ordered data (categories: excellent, good, fair, poor)."|Mantel Haenszel|Test of row mean score differences based on modified ridits (standardizing the mid-rank)||||||0.958
72626139|NCT00402987|144781737|SUPERIORITY_OR_OTHER_LEGACY|||||||0.747||95.0||||"Analysis at 24 hours~Overall test of Celecoxib 100mg/Placebo versus Celecoxib 100mg/50mg that takes into account the ordered data (categories: excellent, good, fair, poor)."|Mantel Haenszel|Test of row mean score differences based on modified ridits (standardizing the mid-rank)||||||0.747
72626140|NCT00402987|144781738|SUPERIORITY_OR_OTHER_LEGACY|||||||0.999||95.0||||"Analysis at 15 min~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.999
72626141|NCT00402987|144781738|SUPERIORITY_OR_OTHER_LEGACY|||||||0.609||95.0||||"Analysis at 30 min~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.609
72626142|NCT00402987|144781738|SUPERIORITY_OR_OTHER_LEGACY|||||||0.076||95.0||||"Analysis at 45 min~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.076
72626143|NCT00402987|144781738|SUPERIORITY_OR_OTHER_LEGACY|||||||0.008||95.0||||"Analysis at 60 min~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.008
72626144|NCT00402987|144781738|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 75 min~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
72572249|NCT02912650|144671815|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-8.21||||0.05|TWO_SIDED|95.0|-16.4|-0.01|||Cochran-Mantel-Haenszel|||0.5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||-0.01|-16.40|0.050
72572250|NCT02912650|144671815|SUPERIORITY_OR_OTHER||CMH adjusted proportions|55.89|||<|0.001|TWO_SIDED|95.0|47.05|64.73|||Cochran-Mantel-Haenszel|||1 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||64.73|47.05|<0.001
72572251|NCT02912650|144671815|SUPERIORITY_OR_OTHER||CMH adjusted proportions|12.99||||0.015|TWO_SIDED|95.0|2.5|23.49|||Cochran-Mantel-Haenszel|||1 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||23.49|2.50|0.015
72572252|NCT02912650|144671815|SUPERIORITY_OR_OTHER||CMH adjusted proportions|7.16||||0.188|TWO_SIDED|95.0|-3.51|17.82|||Cochran-Mantel-Haenszel|||1 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||17.82|-3.51|0.188
72572253|NCT02912650|144671815|SUPERIORITY_OR_OTHER||CMH adjusted proportions|42.61|||<|0.001|TWO_SIDED|95.0|33.85|51.38|||Cochran-Mantel-Haenszel|||1 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||51.38|33.85|<0.001
72626145|NCT00402987|144781738|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 90 min~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
72626146|NCT00402987|144781738|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 1.75 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
72572254|NCT02912650|144671815|SUPERIORITY_OR_OTHER||CMH adjusted proportions|48.58|||<|0.001|TWO_SIDED|95.0|39.63|57.54|||Cochran-Mantel-Haenszel|||1 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||57.54|39.63|<0.001
72572255|NCT02912650|144671815|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-5.98||||0.266|TWO_SIDED|95.0|-16.51|4.55|||Cochran-Mantel-Haenszel|||1 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||4.55|-16.51|0.266
72572256|NCT02912650|144671815|SUPERIORITY_OR_OTHER||CMH adjusted proportions|59.77|||<|0.001|TWO_SIDED|95.0|49.63|69.9|||Cochran-Mantel-Haenszel|||1.5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||69.90|49.63|<0.001
72572257|NCT02912650|144671815|SUPERIORITY_OR_OTHER||CMH adjusted proportions|8.62||||0.094|TWO_SIDED|95.0|-1.46|18.69|||Cochran-Mantel-Haenszel|||1.5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||18.69|-1.46|0.094
72626147|NCT00402987|144781738|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 2 hours~Overall P-value"|Generalized linear model|Continuous data were analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
72626148|NCT00402987|144781738|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 3 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
72572258|NCT02912650|144671815|SUPERIORITY_OR_OTHER||CMH adjusted proportions|10.43||||0.047|TWO_SIDED|95.0|0.15|20.72|||Cochran-Mantel-Haenszel|||1.5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||20.72|0.15|0.047
72572259|NCT02912650|144671815|SUPERIORITY_OR_OTHER||CMH adjusted proportions|50.95|||<|0.001|TWO_SIDED|95.0|40.5|61.4|||Cochran-Mantel-Haenszel|||1.5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||61.40|40.50|<0.001
72572260|NCT02912650|144671815|SUPERIORITY_OR_OTHER||CMH adjusted proportions|49.34|||<|0.001|TWO_SIDED|95.0|38.79|59.89|||Cochran-Mantel-Haenszel|||1.5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||59.89|38.79|<0.001
72572261|NCT02912650|144671815|SUPERIORITY_OR_OTHER||CMH adjusted proportions|1.79||||0.734|TWO_SIDED|95.0|-8.56|12.14|||Cochran-Mantel-Haenszel|||1.5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||12.14|-8.56|0.734
72572262|NCT02912650|144671815|SUPERIORITY_OR_OTHER||CMH adjusted proportions|58.46|||<|0.001|TWO_SIDED|95.0|46.88|70.03|||Cochran-Mantel-Haenszel|||2 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||70.03|46.88|<0.001
72572263|NCT02912650|144671815|SUPERIORITY_OR_OTHER||CMH adjusted proportions|7.01||||0.152|TWO_SIDED|95.0|-2.57|16.59|||Cochran-Mantel-Haenszel|||2 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||16.59|-2.57|0.152
72626149|NCT00402987|144781738|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 4 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
72626150|NCT00402987|144781738|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 5 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
72626151|NCT00402987|144781738|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001||95.0||||"Analysis at 6 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.001
72626152|NCT00402987|144781739|SUPERIORITY_OR_OTHER_LEGACY|||||||0.003||95.0||||"Analysis at 7 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.003
72572264|NCT02912650|144671815|SUPERIORITY_OR_OTHER||CMH adjusted proportions|9.0||||0.073|TWO_SIDED|95.0|-0.83|19.82|||Cochran-Mantel-Haenszel|||2 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||19.82|-0.83|0.073
72572265|NCT02912650|144671815|SUPERIORITY_OR_OTHER||CMH adjusted proportions|51.3|||<|0.001|TWO_SIDED|95.0|39.38|63.21|||Cochran-Mantel-Haenszel|||2 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||63.21|39.38|<0.001
72572266|NCT02912650|144671815|SUPERIORITY_OR_OTHER||CMH adjusted proportions|49.49|||<|0.001|TWO_SIDED|95.0|37.5|61.47|||Cochran-Mantel-Haenszel|||2 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||61.47|37.50|<0.001
72572267|NCT02912650|144671815|SUPERIORITY_OR_OTHER||CMH adjusted proportions|1.99||||0.694|TWO_SIDED|95.0|-7.91|11.89|||Cochran-Mantel-Haenszel|||2 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||11.89|-7.91|0.694
72626153|NCT00402987|144781739|SUPERIORITY_OR_OTHER_LEGACY|||||||0.009||95.0||||"Analysis at 8 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.009
72626154|NCT00402987|144781739|SUPERIORITY_OR_OTHER_LEGACY|||||||0.043||95.0||||"Analysis at 9 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.043
72572268|NCT02912650|144671815|SUPERIORITY_OR_OTHER||CMH adjusted proportions|60.61|||<|0.001|TWO_SIDED|95.0|48.37|72.84|||Cochran-Mantel-Haenszel|||3 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||72.84|48.37|<0.001
72572269|NCT02912650|144671815|SUPERIORITY_OR_OTHER||CMH adjusted proportions|6.58||||0.135|TWO_SIDED|95.0|-2.05|15.2|||Cochran-Mantel-Haenszel|||3 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||15.20|-2.05|0.135
72572270|NCT02912650|144671815|SUPERIORITY_OR_OTHER||CMH adjusted proportions|14.74||||0.002|TWO_SIDED|95.0|5.5|23.97|||Cochran-Mantel-Haenszel|||3 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||23.97|5.50|0.002
72572271|NCT02912650|144671815|SUPERIORITY_OR_OTHER||CMH adjusted proportions|53.82|||<|0.001|TWO_SIDED|95.0|41.31|66.32|||Cochran-Mantel-Haenszel|||3 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||66.32|41.31|<0.001
72572272|NCT02912650|144671815|SUPERIORITY_OR_OTHER||CMH adjusted proportions|45.93|||<|0.001|TWO_SIDED|95.0|33.21|58.66|||Cochran-Mantel-Haenszel|||3 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||58.66|33.21|<0.001
72572273|NCT02912650|144671815|SUPERIORITY_OR_OTHER||CMH adjusted proportions|8.18||||0.091|TWO_SIDED|95.0|-1.32|17.69|||Cochran-Mantel-Haenszel|||3 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||17.69|-1.32|0.091
72572274|NCT02912650|144671815|SUPERIORITY_OR_OTHER||CMH adjusted proportions|60.0|||<|0.001|TWO_SIDED|95.0|47.59|72.42|||Cochran-Mantel-Haenszel|||4 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||72.42|47.59|<0.001
72572275|NCT02912650|144671815|SUPERIORITY_OR_OTHER||CMH adjusted proportions|6.03||||0.159|TWO_SIDED|95.0|-2.36|14.43|||Cochran-Mantel-Haenszel|||4 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||14.43|-2.36|0.159
72626155|NCT00402987|144781739|SUPERIORITY_OR_OTHER_LEGACY|||||||0.032||95.0||||"Analysis at 10 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.032
72626156|NCT00402987|144781739|SUPERIORITY_OR_OTHER_LEGACY|||||||0.029||95.0||||"Analysis at 11 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.029
72626157|NCT00402987|144781739|SUPERIORITY_OR_OTHER_LEGACY|||||||0.066||95.0||||"Analysis at 12 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.066
72626158|NCT00402987|144781739|SUPERIORITY_OR_OTHER_LEGACY|||||||0.482||95.0||||"Analysis at 24 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.482
72626159|NCT00402987|144781740|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.3|||<|0.001||95.0|0.8|1.9||Pairwise comparison. No adjustment made for multiplicity.|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||1.9|0.8|<0.001
72626160|NCT00402987|144781740|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.9||||0.002||95.0|0.4|1.5||Pairwise comparison. No adjustment made for multiplicity.|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||1.5|0.4|0.002
72572276|NCT02912650|144671815|SUPERIORITY_OR_OTHER||CMH adjusted proportions|15.32|||<|0.001|TWO_SIDED|95.0|6.23|24.41|||Cochran-Mantel-Haenszel|||4 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||24.41|6.23|<0.001
72572277|NCT02912650|144671815|SUPERIORITY_OR_OTHER||CMH adjusted proportions|53.79|||<|0.001|TWO_SIDED|95.0|41.08|66.5|||Cochran-Mantel-Haenszel|||4 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||66.50|41.08|<0.001
72572278|NCT02912650|144671815|SUPERIORITY_OR_OTHER||CMH adjusted proportions|44.76|||<|0.001|TWO_SIDED|95.0|31.72|57.81|||Cochran-Mantel-Haenszel|||4 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||57.81|31.72|<0.001
72572279|NCT02912650|144671815|SUPERIORITY_OR_OTHER||CMH adjusted proportions|9.28||||0.052|TWO_SIDED|95.0|-0.08|18.64|||Cochran-Mantel-Haenszel|||4 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||18.64|-0.08|0.052
72572280|NCT02912650|144671815|SUPERIORITY_OR_OTHER||CMH adjusted proportions|57.57|||<|0.001|TWO_SIDED|95.0|44.75|70.39|||Cochran-Mantel-Haenszel|||5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||70.39|44.75|<0.001
72572281|NCT02912650|144671815|SUPERIORITY_OR_OTHER||CMH adjusted proportions|6.06||||0.147|TWO_SIDED|95.0|-2.13|14.25|||Cochran-Mantel-Haenszel|||5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||14.25|-2.13|0.147
72572282|NCT02912650|144671815|SUPERIORITY_OR_OTHER||CMH adjusted proportions|15.3|||<|0.001|TWO_SIDED|95.0|6.39|24.21|||Cochran-Mantel-Haenszel|||5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||24.21|6.39|<0.001
72572283|NCT02912650|144671815|SUPERIORITY_OR_OTHER||CMH adjusted proportions|51.32|||<|0.001|TWO_SIDED|95.0|38.16|64.48|||Cochran-Mantel-Haenszel|||5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||64.48|38.16|<0.001
72572284|NCT02912650|144671815|SUPERIORITY_OR_OTHER||CMH adjusted proportions|42.28|||<|0.001|TWO_SIDED|95.0|28.74|55.82|||Cochran-Mantel-Haenszel|||5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||55.82|28.74|<0.001
72572285|NCT02912650|144671815|SUPERIORITY_OR_OTHER||CMH adjusted proportions|9.27||||0.049|TWO_SIDED|95.0|0.04|18.49|||Cochran-Mantel-Haenszel|||5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||18.49|0.04|0.049
72572286|NCT02912650|144671815|SUPERIORITY_OR_OTHER||CMH adjusted proportions|58.71|||<|0.001|TWO_SIDED|95.0|45.93|71.49|||Cochran-Mantel-Haenszel|||6 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||71.49|45.93|<0.001
72572287|NCT02912650|144671815|SUPERIORITY_OR_OTHER||CMH adjusted proportions|6.64||||0.105|TWO_SIDED|95.0|-1.38|14.67|||Cochran-Mantel-Haenszel|||6 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||14.67|-1.38|0.105
72572288|NCT02912650|144671815|SUPERIORITY_OR_OTHER||CMH adjusted proportions|15.86|||<|0.001|TWO_SIDED|95.0|7.08|24.63|||Cochran-Mantel-Haenszel|||6 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||24.63|7.08|<0.001
72572289|NCT02912650|144671815|SUPERIORITY_OR_OTHER||CMH adjusted proportions|51.9|||<|0.001|TWO_SIDED|95.0|38.76|65.04|||Cochran-Mantel-Haenszel|||6 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||65.04|38.76|<0.001
72572290|NCT02912650|144671815|SUPERIORITY_OR_OTHER||CMH adjusted proportions|42.94|||<|0.001|TWO_SIDED|95.0|29.44|56.44|||Cochran-Mantel-Haenszel|||6 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||56.44|29.44|<0.001
72572291|NCT02912650|144671815|SUPERIORITY_OR_OTHER||CMH adjusted proportions|9.23||||0.048|TWO_SIDED|95.0|0.06|18.4|||Cochran-Mantel-Haenszel|||6 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||18.40|0.06|0.048
72572292|NCT02912650|144671815|SUPERIORITY_OR_OTHER||CMH adjusted proportions|58.71|||<|0.001|TWO_SIDED|95.0|45.93|71.49|||Cochran-Mantel-Haenszel|||7 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||71.49|45.93|<0.001
72572293|NCT02912650|144671815|SUPERIORITY_OR_OTHER||CMH adjusted proportions|6.64||||0.105|TWO_SIDED|95.0|-1.38|14.67|||Cochran-Mantel-Haenszel|||7 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||14.67|-1.38|0.105
72572294|NCT02912650|144671815|SUPERIORITY_OR_OTHER||CMH adjusted proportions|15.86|||<|0.001|TWO_SIDED|95.0|7.08|24.63|||Cochran-Mantel-Haenszel|||7 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||24.63|7.08|<0.001
72572295|NCT02912650|144671815|SUPERIORITY_OR_OTHER||CMH adjusted proportions|51.9|||<|0.001|TWO_SIDED|95.0|38.76|65.04|||Cochran-Mantel-Haenszel|||7 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||65.04|38.76|<0.001
72572296|NCT02912650|144671815|SUPERIORITY_OR_OTHER||CMH adjusted proportions|42.94|||<|0.001|TWO_SIDED|95.0|29.44|56.44|||Cochran-Mantel-Haenszel|||7 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||56.44|29.44|<0.001
72572297|NCT02912650|144671815|SUPERIORITY_OR_OTHER||CMH adjusted proportions|9.23||||0.048|TWO_SIDED|95.0|0.06|18.4|||Cochran-Mantel-Haenszel|||7 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||18.40|0.06|0.048
72572298|NCT02912650|144671815|SUPERIORITY_OR_OTHER||CMH adjusted proportions|58.71|||<|0.001||95.0|45.93|71.49|||Cochran-Mantel-Haenszel|||8 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores||71.49|45.93|<0.001
72572299|NCT02912650|144671815|SUPERIORITY_OR_OTHER||CMH adjusted proportions|6.64||||0.105|TWO_SIDED|95.0|-1.38|14.67|||Cochran-Mantel-Haenszel|||8 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores||14.67|-1.38|0.105
72572300|NCT02912650|144671815|SUPERIORITY_OR_OTHER||CMH adjusted proportions|15.23|||<|0.001|TWO_SIDED|95.0|6.48|23.97|||Cochran-Mantel-Haenszel|||8 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||23.97|6.48|<0.001
72572301|NCT02912650|144671815|SUPERIORITY_OR_OTHER||CMH adjusted proportions|51.9|||<|0.001||95.0|38.76|65.04|||Cochran-Mantel-Haenszel|||8 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||65.04|38.76|<0.001
72626161|NCT00402987|144781740|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.4||||0.186||95.0|-1.0|0.2||Pairwise comparison. No adjustment made for multiplicity.|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||0.2|-1.0|0.186
72572302|NCT02912650|144671815|SUPERIORITY_OR_OTHER||CMH adjusted proportions|43.61|||<|0.001|TWO_SIDED|95.0|30.15|57.07|||Cochran-Mantel-Haenszel|||8 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||57.07|30.15|<0.001
72572303|NCT02912650|144671815|SUPERIORITY_OR_OTHER||CMH adjusted proportions|8.61||||0.065|TWO_SIDED|95.0|-0.55|17.76|||Cochran-Mantel-Haenszel|||8 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||17.76|-0.55|0.065
72626162|NCT00402987|144781741|SUPERIORITY_OR_OTHER_LEGACY|||||||0.961||95.0||||"Analysis at 15 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.961
72572304|NCT02912650|144671815|SUPERIORITY_OR_OTHER||CMH adjusted proportions|58.71|||<|0.001||95.0|45.93|71.49|||Cochran-Mantel-Haenszel|||9 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||71.49|45.93|<0.001
72572305|NCT02912650|144671815|SUPERIORITY_OR_OTHER||CMH adjusted proportions|6.64||||0.105|TWO_SIDED|95.0|-1.38|14.67|||Cochran-Mantel-Haenszel|||9 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||14.67|-1.38|0.105
72626163|NCT00402987|144781741|SUPERIORITY_OR_OTHER_LEGACY|||||||0.985||95.0||||"Analysis at 15 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.985
72572306|NCT02912650|144671815|SUPERIORITY_OR_OTHER||CMH adjusted proportions|13.98||||0.002|TWO_SIDED|95.0|5.3|22.67|||Cochran-Mantel-Haenszel|||9 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||22.67|5.30|0.002
72572307|NCT02912650|144671815|SUPERIORITY_OR_OTHER||CMH adjusted proportions|51.9|||<|0.001|TWO_SIDED|95.0|38.76|65.04|||Cochran-Mantel-Haenszel|||9 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||65.04|38.76|<0.001
72572308|NCT02912650|144671815|SUPERIORITY_OR_OTHER||CMH adjusted proportions|44.89|||<|0.001||95.0|31.51|58.26|||Cochran-Mantel-Haenszel|||9 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||58.26|31.51|<0.001
72626164|NCT00402987|144781741|SUPERIORITY_OR_OTHER_LEGACY|||||||0.975||95.0||||"Analysis at 15 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.975
72626165|NCT00402987|144781741|SUPERIORITY_OR_OTHER_LEGACY|||||||0.532||95.0||||"Analysis at 30 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.532
72626166|NCT00402987|144781741|SUPERIORITY_OR_OTHER_LEGACY|||||||0.69||95.0||||"Analysis at 30 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.690
72626167|NCT00402987|144781741|SUPERIORITY_OR_OTHER_LEGACY|||||||0.82||95.0||||"Analysis at 30 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.820
72626168|NCT00402987|144781741|SUPERIORITY_OR_OTHER_LEGACY|||||||0.18||95.0||||"Analysis at 45 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.180
72532174|NCT04550234|144593409|OTHER||Geometric mean ratio|87.14|||||TWO_SIDED|90.0|81.63|93.01||||||"Statistical Comparison of Allopurinol~Analysis of variance (ANOVA) of log transformed PK parameter with treatment, sequence, period as fixed effects and subject nested within sequence as random effect"||93.01|81.63|
72532175|NCT04550234|144593409|OTHER||Geometric mean ratio|91.45|||||TWO_SIDED|90.0|85.67|97.61||||||"Statistical Comparison of Allopurinol~Analysis of variance (ANOVA) of log transformed PK parameter with treatment, sequence, period as fixed effects and subject nested within sequence as random effect"||97.61|85.67|
72532176|NCT04550234|144593409|OTHER||Geometric mean ratio|90.91|||||TWO_SIDED|90.0|87.98|93.94||||||"Statistical Comparison of Oxypurinol~Analysis of variance (ANOVA) of log transformed PK parameter with treatment, sequence, period as fixed effects and subject nested within sequence as random effect"||93.94|87.98|
72532177|NCT04550234|144593409|OTHER||Geometric mean ratio|99.37|||||TWO_SIDED|90.0|96.17|102.68||||||"Statistical Comparison of Oxypurinol~Analysis of variance (ANOVA) of log transformed PK parameter with treatment, sequence, period as fixed effects and subject nested within sequence as random effect"||102.68|96.17|
72532178|NCT04550234|144593409|OTHER||Geometric mean ratio|89.18|||||TWO_SIDED|90.0|86.3|92.15||||||"Statistical Comparison of Oxypurinol~Analysis of variance (ANOVA) of log transformed PK parameter with treatment, sequence, period as fixed effects and subject nested within sequence as random effect"||92.15|86.30|
72532179|NCT04550234|144593421|OTHER||Geometric mean ratio|108.25|||||TWO_SIDED|90.0|94.13|124.49||||||"Statistical Comparison of Verinurad~Analysis of variance (ANOVA) of log transformed PK parameter with treatment, sequence, period as fixed effects and subject nested within sequence as random effect"||124.49|94.13|
72532180|NCT04550234|144593421|OTHER||Geometric mean ratio|96.57|||||TWO_SIDED|90.0|90.96|102.53||||||"Statistical Comparison of Allopurinol~Analysis of variance (ANOVA) of log transformed PK parameter with treatment, sequence, period as fixed effects and subject nested within sequence as random effect"||102.53|90.96|
72532181|NCT04550234|144593421|OTHER||Geometric mean ratio|98.75|||||TWO_SIDED|90.0|95.27|102.36||||||"Statistical Comparison of Oxypurinol~Analysis of variance (ANOVA) of log transformed PK parameter with treatment, sequence, period as fixed effects and subject nested within sequence as random effect"||102.36|95.27|
72532182|NCT04550234|144593422|OTHER||Geometric mean ratio|109.27|||||TWO_SIDED|90.0|94.55|126.29||||||"Statistical Comparison of Verinurad~Analysis of variance (ANOVA) of log transformed PK parameter with treatment, sequence, period as fixed effects and subject nested within sequence as random effect"||126.29|94.55|
72532183|NCT04550234|144593422|OTHER||Geometric mean ratio|96.47|||||TWO_SIDED|90.0|90.38|102.97||||||"Statistical Comparison of Allopurinol~Analysis of variance (ANOVA) of log transformed PK parameter with treatment, sequence, period as fixed effects and subject nested within sequence as random effect"||102.97|90.38|
72532184|NCT04550234|144593422|OTHER||Geometric mean ratio|97.48|||||TWO_SIDED|90.0|94.34|100.73||||||"Statistical Comparison of Oxypurinol~Analysis of variance (ANOVA) of log transformed PK parameter with treatment, sequence, period as fixed effects and subject nested within sequence as random effect"||100.73|94.34|
72532185|NCT04550234|144593423|OTHER||Geometric mean ratio|131.28|||||TWO_SIDED|90.0|107.03|161.02||||||"Statistical Comparison of Verinurad~Analysis of variance (ANOVA) of log transformed PK parameter with treatment, sequence, period as fixed effects and subject nested within sequence as random effect"||161.02|107.03|
72532186|NCT04550234|144593423|OTHER||Geometric mean ratio|96.39|||||TWO_SIDED|90.0|81.23|114.39||||||"Statistical Comparison of Allopurinol~Analysis of variance (ANOVA) of log transformed PK parameter with treatment, sequence, period as fixed effects and subject nested within sequence as random effect"||114.39|81.23|
72532187|NCT04550234|144593423|OTHER||Geometric mean ratio|95.15|||||TWO_SIDED|90.0|91.08|99.4||||||"Statistical Comparison of Oxypurinol~Analysis of variance (ANOVA) of log transformed PK parameter with treatment, sequence, period as fixed effects and subject nested within sequence as random effect"||99.40|91.08|
72532188|NCT00224952|144593425|OTHER|||||||0.004|||||||Regression, Linear|||Least squares linear regression evaluating fractional analyte recovery (4-Methylthio-2-hydroxyiminostilbene) as a function of age||||0.004
72532189|NCT00224952|144593425|OTHER|||||||0.032|||||||Regression, Linear|||Least squares linear regression evaluating fractional analyte recovery (Log (4-Methylthio-2-hydroxyiminostilbene) as a function of age||||0.032
72532190|NCT00224952|144593425|OTHER|||||||0.018|||||||Regression, Linear|||Least squares linear regression evaluating fractional analyte recovery (Fractional Recovery (MTHIS)) as a function of age||||0.018
72532191|NCT00224952|144593425|OTHER|||||||0.033|||||||Regression, Linear|||Least squares linear regression evaluating fractional analyte recovery (Log (Fractional Recovery MTHIS)) as a function of age||||0.033
72532192|NCT00224952|144593425|OTHER|||||||0.0004|||||||Regression, Linear|||Least squares linear regression evaluating fractional analyte recovery (Log (5-N-acetylcysteine-3-ene VPA isomers)) as a function of age||||0.0004
72532193|NCT00224952|144593425|OTHER|||||||0.0003|||||||Regression, Linear|||Least squares linear regression evaluating fractional analyte recovery (Log (5-N-acetylcysteine-2-ene VPA) ) as a function of age||||0.0003
72532194|NCT00224952|144593425|OTHER||||||<|0.0001|||||||Regression, Linear|||Least squares linear regression evaluating fractional analyte recovery (Total N-acetylcysteine conjugates) as a function of age||||<0.0001
72532195|NCT00224952|144593425|OTHER|||||||0.522|||||||Regression, Linear|||Least squares linear regression evaluating fractional analyte recovery (Log (Fractional Recovery NAC-3-ene VPA isomers)) as a function of age||||0.522
72532196|NCT00224952|144593425|OTHER|||||||0.925|||||||Regression, Linear|||Least squares linear regression evaluating fractional analyte recovery (Log (Fractional Recovery NAC-2-ene VPA) ) as a function of age||||0.925
72532197|NCT00224952|144593425|OTHER|||||||0.469|||||||Regression, Linear|||Least squares linear regression evaluating fractional analyte recovery (Log (Fractional Recovery Total NAC conjugates) as a function of age||||0.469
72626169|NCT00402987|144781741|SUPERIORITY_OR_OTHER_LEGACY|||||||0.344||95.0||||"Analysis at 45 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.344
72626170|NCT00402987|144781741|SUPERIORITY_OR_OTHER_LEGACY|||||||0.693||95.0||||"Analysis at 45 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.693
72572309|NCT02912650|144671815|SUPERIORITY_OR_OTHER||CMH adjusted proportions|7.36||||0.113|TWO_SIDED|95.0|-1.73|16.45|||Cochran-Mantel-Haenszel|||9 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||16.45|-1.73|0.113
72572310|NCT02912650|144671815|SUPERIORITY_OR_OTHER||CMH adjusted proportions|56.94|||<|0.001|TWO_SIDED|95.0|43.95|69.94|||Cochran-Mantel-Haenszel|||10 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||69.94|43.95|<0.001
72572311|NCT02912650|144671815|SUPERIORITY_OR_OTHER||CMH adjusted proportions|6.07||||0.136|TWO_SIDED|95.0|-1.91|14.05|||Cochran-Mantel-Haenszel|||10 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||14.05|-1.91|0.136
72572312|NCT02912650|144671815|SUPERIORITY_OR_OTHER||CMH adjusted proportions|13.98||||0.002|TWO_SIDED|95.0|5.3|22.67|||Cochran-Mantel-Haenszel|||10 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||22.67|5.30|0.002
72572313|NCT02912650|144671815|SUPERIORITY_OR_OTHER||CMH adjusted proportions|50.74|||<|0.001|TWO_SIDED|95.0|37.39|64.09|||Cochran-Mantel-Haenszel|||10 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||64.09|37.39|<0.001
72572314|NCT02912650|144671815|SUPERIORITY_OR_OTHER||CMH adjusted proportions|43.16|||<|0.001|TWO_SIDED|95.0|29.56|56.75|||Cochran-Mantel-Haenszel|||10 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||56.75|29.56|<0.001
72572315|NCT02912650|144671815|SUPERIORITY_OR_OTHER||CMH adjusted proportions|7.91||||0.087|TWO_SIDED|95.0|-1.15|16.97|||Cochran-Mantel-Haenszel|||10 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||16.97|-1.15|0.087
72572316|NCT02912650|144671815|SUPERIORITY_OR_OTHER||CMH adjusted proportions|56.94|||<|0.001|TWO_SIDED|95.0|43.95|69.94|||Cochran-Mantel-Haenszel|||11 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||69.94|43.95|<0.001
72572317|NCT02912650|144671815|SUPERIORITY_OR_OTHER||CMH adjusted proportions|6.07||||0.136|TWO_SIDED|95.0|-1.91|14.05|||Cochran-Mantel-Haenszel|||11 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||14.05|-1.91|0.136
72572318|NCT02912650|144671815|SUPERIORITY_OR_OTHER||CMH adjusted proportions|13.98||||0.002|TWO_SIDED|95.0|5.3|22.67|||Cochran-Mantel-Haenszel|||11 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||22.67|5.30|0.002
72572319|NCT02912650|144671815|SUPERIORITY_OR_OTHER||CMH adjusted proportions|50.74|||<|0.001|TWO_SIDED|95.0|37.39|64.09|||Cochran-Mantel-Haenszel|||11 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||64.09|37.39|<0.001
72572320|NCT02912650|144671815|SUPERIORITY_OR_OTHER||CMH adjusted proportions|43.16|||<|0.001|TWO_SIDED|95.0|29.56|56.75|||Cochran-Mantel-Haenszel|||11 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||56.75|29.56|<0.001
72572321|NCT02912650|144671815|SUPERIORITY_OR_OTHER||CMH adjusted proportions|7.91||||0.087|TWO_SIDED|95.0|-1.15|16.97|||Cochran-Mantel-Haenszel|||11 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||16.97|-1.15|0.087
72626171|NCT00402987|144781741|SUPERIORITY_OR_OTHER_LEGACY|||||||0.039||95.0||||"Analysis at 60 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.039
72572322|NCT02912650|144671815|SUPERIORITY_OR_OTHER||CMH adjusted proportions|56.94|||<|0.001|TWO_SIDED|95.0|43.95|69.94|||Cochran-Mantel-Haenszel|||12 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||69.94|43.95|<0.001
72626172|NCT00402987|144781741|SUPERIORITY_OR_OTHER_LEGACY|||||||0.154||95.0||||"Analysis at 60 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.154
72626173|NCT00402987|144781741|SUPERIORITY_OR_OTHER_LEGACY|||||||0.521||95.0||||"Analysis at 60 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.521
72572323|NCT02912650|144671815|SUPERIORITY_OR_OTHER||CMH adjusted proportions|6.07||||0.136|TWO_SIDED|95.0|-1.91|14.05|||Cochran-Mantel-Haenszel|||12 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||14.05|-1.91|0.136
72572324|NCT02912650|144671815|SUPERIORITY_OR_OTHER||CMH adjusted proportions|13.98||||0.002|TWO_SIDED|95.0|5.3|22.67|||Cochran-Mantel-Haenszel|||12 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||22.67|5.30|0.002
72572325|NCT02912650|144671815|SUPERIORITY_OR_OTHER||CMH adjusted proportions|50.74|||<|0.001|TWO_SIDED|95.0|37.39|64.09|||Cochran-Mantel-Haenszel|||12 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||64.09|37.39|<0.001
72532198|NCT01928758|144593426|OTHER||Mean Difference (Final Values)|-175.7|||<|0.0001|TWO_SIDED|95.0|-218.3|-133.1||Complete case analysis|Regression, Linear|Model was adjusted for baseline cotinine after smoking usual nicotine content cigarettes for 2-weeks.|The direction of comparison is reduced nicotine content vs. usual nicotine content cigarette treatment group.|||-133.1|-218.3|<0.0001
72532199|NCT01928758|144593427|OTHER||Mean Difference (Final Values)|0.69||||0.16|TWO_SIDED|95.0|-0.28|1.65||Complete case analysis|Regression, Linear|Model was adjusted for baseline score after smoking usual nicotine content cigarettes for 2 weeks|The direction of comparison is reduced nicotine content vs. usual nicotine content cigarette treatment group|||1.65|-0.28|0.16
72532200|NCT01928758|144593428|OTHER||Mean Difference (Final Values)|0.38||||0.67|TWO_SIDED|95.0|-1.4|2.16||Complete case analysis|Regression, Linear|Model was adjusted for baseline score after smoking usual nicotine content cigarettes for 2 weeks|The direction of comparison is reduced nicotine content vs. usual nicotine content cigarette treatment group.|||2.16|-1.40|0.67
72532201|NCT01928758|144593429|OTHER||Mean Difference (Final Values)|-0.31||||0.65|TWO_SIDED|95.0|-1.68|1.05||Complete case analysis|Regression, Linear|Model was adjusted for baseline score after smoking usual nicotine content cigarettes for 2 weeks|The direction of comparison is reduced nicotine content vs. usual nicotine content cigarette treatment group|||1.05|-1.68|0.65
72532202|NCT00649220|144593437|SUPERIORITY_OR_OTHER|||||||0.22626||95.0|||||t-test, 2 sided|||Two-side, paired t-test on the null hypothesis that antipsychotics are reduced by 10% compared to baseline||||0.22626
72532203|NCT00649220|144593437|SUPERIORITY_OR_OTHER|||||||0.34192||95.0|||||Wilcoxon signed rank test|||Wilcoxon signed rank test on the null hypothesis that antipsychotics are reduced by 10% compared to baseline||||0.34192
72532204|NCT00368069|144593468|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.155||||0.038||95.0|0.009|0.301|||ANCOVA|Analysis of covariance (ANCOVA) on (log-) POS freq/week over Treatment period with Treatment, (log-) Baseline POS freq/week as covariate.||||0.301|0.009|0.038
72532205|NCT00368069|144593468|SUPERIORITY_OR_OTHER_LEGACY||Percent reduction over Placebo|14.4||||||95.0|0.9|26.0|||Transf. of ANCOVA results on log data|Percent Reduction of Keppra over PBO is calculated based on the ANCOVA on log data as 100\*(1-exp(LSmeans Keppra -LSMeans Placebo))||Treatment difference was assessed through the percent reduction in POS freq/week of Keppra over Placebo by back transformation of the results of the ANCOVA on log data||26.0|0.9|
72532206|NCT00368069|144593470|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.158||||0.034||95.0|0.012|0.305|||ANCOVA|ANCOVA on (log-) seizure frequency per week over Treatment period with Treatment, (log-) Baseline seizure frequency per week as covariate.||||0.305|0.012|0.034
72532207|NCT00368069|144593470|SUPERIORITY_OR_OTHER_LEGACY||Percent reduction over Placebo|14.7||||||95.0|1.2|26.3|||Transf. of ANCOVA results on log data|Percent Reduction of Keppra over Placebo is calculated based on the ANCOVA on log data as 100\*(1-exp(LSmeans Keppra -LSMeans Placebo))||Treatment difference was assessed through the percent reduction in POS frequency per week of Keppra over Placebo by back transformation of the results of the ANCOVA on log data||26.3|1.2|
72532208|NCT00368069|144593471|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.84||||0.07||95.0|0.95|3.55|||Regression, Logistic|Logistic regression analysis including Treatment as a factor.|Based on the number of evaluable patients. A patient is considered as evaluable for the response status if he has seizure information in at least one of the period (baseline or treatment period.|||3.55|0.95|0.070
72532209|NCT00368069|144593472|SUPERIORITY_OR_OTHER_LEGACY|||||||0.033||95.0|||||Mantel Haenszel|Subjects with missing data during the Treatment period were considered in the category \<-25%.||||||0.033
72532210|NCT00368069|144593473|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.205||||0.003||95.0|0.07|0.341|||ANCOVA|ANCOVA on (log-) Treatment POS frequency per week with Treatment and (log-) Baseline POS frequency per week as covariate||||0.341|0.070|0.003
72532211|NCT00368069|144593473|SUPERIORITY_OR_OTHER_LEGACY||Percent reduction over Placebo|18.6||||||95.0|6.7|28.9|||Transf. of ANCOVA results on log data|Percent Reduction of Keppra over Placebo is calculated based on the ANCOVA on log data as 100\*(1-exp(LSmeans Keppra -LSMeans Placebo))||Treatment difference was assessed through the percent reduction in POS frequency per week of Keppra over Placebo by back transformation of the results of the ANCOVA on log data||28.9|6.7|
72532212|NCT04680273|144593482|OTHER||Geometric mean ratio|0.573|STANDARD_DEVIATION|1.11|||||||||||The geometric coefficient of variation (%) for the AUC(0-72) geometric mean ratio was 10.4%. The standard deviation (SD) reported is a geometric SD.|The geometric mean ratio was calculated for the AUC(0-72) of GDC-9545 in plasma samples compared with the AUC(0-72) of total radioactivity in plasma samples.||||
72532213|NCT04680273|144593482|OTHER||Geometric mean ratio|0.752|STANDARD_DEVIATION|1.036|||||||||||The geometric coefficient of variation (%) for the AUC(0-72) geometric mean ratio was 3.5%. The standard deviation (SD) reported is a geometric SD.|The geometric mean ratio was calculated for the AUC(0-72) of total radioactivity (TR) in whole blood samples compared with the AUC(0-72) of TR in plasma samples.||||
72532214|NCT04680273|144593483|OTHER||Geometric mean ratio|0.625|STANDARD_DEVIATION|1.134|||||||||||The geometric coefficient of variation (%) for the AUC(0-t) geometric mean ratio was 12.7%. The standard deviation (SD) reported is a geometric SD.|The geometric mean ratio was calculated for the AUC(0-t) of GDC-9545 in plasma samples compared with the AUC(0-t) of total radioactivity in plasma samples.||||
72532215|NCT04680273|144593483|OTHER||Geometric mean ratio|0.79|STANDARD_DEVIATION|1.171|||||||||||The geometric coefficient of variation (%) for the AUC(0-t) geometric mean ratio was 15.9%. The standard deviation (SD) reported is a geometric SD.|The geometric mean ratio was calculated for the AUC(0-t) of total radioactivity (TR) in whole blood samples compared with the AUC(0-t) of TR in plasma samples.||||
72532216|NCT01430559|144593527|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.82|STANDARD_ERROR_OF_MEAN|0.19|<|0.0001|TWO_SIDED|95.0|-1.2|-0.43||P-value and 95% confidence interval for least squares mean difference were calculated from analysis of covariance (ANCOVA, repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.|ANCOVA|||||-0.43|-1.20|<0.0001
72532217|NCT01430559|144593528|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.37|STANDARD_ERROR_OF_MEAN|0.14||0.0103|TWO_SIDED|95.0|-0.65|-0.09||P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.|ANCOVA|||Pain subscale (Week 2)||-0.09|-0.65|0.0103
72626174|NCT00402987|144781741|SUPERIORITY_OR_OTHER_LEGACY|||||||0.006||95.0||||"Analysis at 75 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.006
72532218|NCT01430559|144593528|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.35|STANDARD_ERROR_OF_MEAN|0.16||0.0295|TWO_SIDED|95.0|-0.67|-0.04||P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.|ANCOVA|||Pain subscale (Week 4)||-0.04|-0.67|0.0295
72532219|NCT01430559|144593528|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.52|STANDARD_ERROR_OF_MEAN|0.18||0.0041|TWO_SIDED|95.0|-0.87|-0.17||P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.|ANCOVA|||Pain subscale (Week 8)||-0.17|-0.87|0.0041
72532220|NCT01430559|144593528|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.82|STANDARD_ERROR_OF_MEAN|0.19|<|0.0001|TWO_SIDED|95.0|-1.2|-0.43||P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.|ANCOVA|||Pain subscale (Week 12)||-0.43|-1.20|<0.0001
72532221|NCT01430559|144593528|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.33|STANDARD_ERROR_OF_MEAN|0.16||0.0369|TWO_SIDED|95.0|-0.64|-0.02||P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.|ANCOVA|||Stiffness subscale (Week 2)||-0.02|-0.64|0.0369
72532222|NCT01430559|144593528|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.18||0.2642|TWO_SIDED|95.0|-0.54|0.15||P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.|ANCOVA|||Stiffness subscale (Week 4)||0.15|-0.54|0.2642
72532223|NCT01430559|144593528|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.47|STANDARD_ERROR_OF_MEAN|0.19||0.014|TWO_SIDED|95.0|-0.84|-0.1||P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.|ANCOVA|||Stiffness subscale (Week 8)||-0.10|-0.84|0.0140
72532224|NCT01430559|144593528|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.67|STANDARD_ERROR_OF_MEAN|0.2||0.0009|TWO_SIDED|95.0|-1.06|-0.28||P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.|ANCOVA|||Stiffness subscale (Week 12)||-0.28|-1.06|0.0009
72532225|NCT01430559|144593528|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.44|STANDARD_ERROR_OF_MEAN|0.14||0.0017|TWO_SIDED|95.0|-0.72|-0.17||P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.|ANCOVA|||Physical function subscale (Week 2)||-0.17|-0.72|0.0017
72532226|NCT01430559|144593528|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.35|STANDARD_ERROR_OF_MEAN|0.16||0.0328|TWO_SIDED|95.0|-0.66|-0.03||P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.|ANCOVA|||Physical function subscale (Week 4)||-0.03|-0.66|0.0328
72532227|NCT01430559|144593528|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.51|STANDARD_ERROR_OF_MEAN|0.18||0.0043|TWO_SIDED|95.0|-0.86|-0.16||P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.|ANCOVA|||Physical function subscale (Week 8)||-0.16|-0.86|0.0043
72532228|NCT01430559|144593528|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.81|STANDARD_ERROR_OF_MEAN|0.19|<|0.0001|TWO_SIDED|95.0|-1.19|-0.43||P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.|ANCOVA|||Physical function subscale (Week 12)||-0.43|-1.19|<0.0001
72532229|NCT01430559|144593528|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.38|STANDARD_ERROR_OF_MEAN|0.13||0.0051|TWO_SIDED|95.0|-0.65|-0.12||P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.|ANCOVA|||Average score (Week 2)||-0.12|-0.65|0.0051
72532230|NCT01430559|144593528|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.16||0.0593|TWO_SIDED|95.0|-0.61|0.01||P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.|ANCOVA|||Average score (Week 4)||0.01|-0.61|0.0593
72532231|NCT01430559|144593528|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.17||0.0046|TWO_SIDED|95.0|-0.84|-0.16||P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.|ANCOVA|||Average score (Week 8)||-0.16|-0.84|0.0046
72532232|NCT01430559|144593528|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.76|STANDARD_ERROR_OF_MEAN|0.19|<|0.0001|TWO_SIDED|95.0|-1.14|-0.39||P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.|ANCOVA|||Average score (Week 12)||-0.39|-1.14|<0.0001
72626175|NCT00402987|144781741|SUPERIORITY_OR_OTHER_LEGACY|||||||0.07||95.0||||"Analysis at 75 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.070
72626176|NCT00402987|144781741|SUPERIORITY_OR_OTHER_LEGACY|||||||0.344||95.0||||"Analysis at 75 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.344
72532233|NCT01430559|144593529|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.62|STANDARD_ERROR_OF_MEAN|0.16||0.0002|TWO_SIDED|95.0|-0.94|-0.3||P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.|ANCOVA|||Walking on flat surface (Week 2)||-0.30|-0.94|0.0002
72532234|NCT01430559|144593529|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.57|STANDARD_ERROR_OF_MEAN|0.18||0.0015|TWO_SIDED|95.0|-0.92|-0.22||P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.|ANCOVA|||Walking on flat surface (Week 4)||-0.22|-0.92|0.0015
72532235|NCT01430559|144593529|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.19||0.0003|TWO_SIDED|95.0|-1.08|-0.32||P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.|ANCOVA|||Walking on flat surface (Week 8)||-0.32|-1.08|0.0003
72532236|NCT01430559|144593529|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.93|STANDARD_ERROR_OF_MEAN|0.21|<|0.0001|TWO_SIDED|95.0|-1.34|-0.51||P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.|ANCOVA|||Walking on flat surface (Week 12)||-0.51|-1.34|<0.0001
72532237|NCT01430559|144593529|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.35|STANDARD_ERROR_OF_MEAN|0.17||0.0363|TWO_SIDED|95.0|-0.67|-0.02||P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.|ANCOVA|||Going up or down stairs (Week 2)||-0.02|-0.67|0.0363
72532238|NCT01430559|144593529|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.39|STANDARD_ERROR_OF_MEAN|0.18||0.0311|TWO_SIDED|95.0|-0.75|-0.04||P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.|ANCOVA|||Going up or down stairs (Week 4)||-0.04|-0.75|0.0311
72532239|NCT01430559|144593529|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.55|STANDARD_ERROR_OF_MEAN|0.2||0.0057|TWO_SIDED|95.0|-0.94|-0.16||P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.|ANCOVA|||Going up or down stairs (Week 8)||-0.16|-0.94|0.0057
72532240|NCT01430559|144593529|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-1.08|STANDARD_ERROR_OF_MEAN|0.22|<|0.0001|TWO_SIDED|95.0|-1.52|-0.64||P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.|ANCOVA|||Going up or down stairs (Week 12)||-0.64|-1.52|<0.0001
72532241|NCT01430559|144593531|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.42||||0.2373|TWO_SIDED|95.0|0.79|2.55||P-value and 95% confidence interval for odds ratio were calculated from logistic regression model (including baseline value and treatment group as factors) for binary data for comparison of meloxicam group versus placebo.|Regression, Logistic|||\>=30% reduction (Week 2)||2.55|0.79|0.2373
72532242|NCT01430559|144593531|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.38||||0.2069|TWO_SIDED|95.0|0.84|2.26||P-value and 95% confidence interval for odds ratio were calculated from logistic regression model (including baseline value and treatment group as factors) for binary data for comparison of meloxicam group versus placebo.|Regression, Logistic|||\>=30% reduction (Week 4)||2.26|0.84|0.2069
72532243|NCT01430559|144593531|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.56||||0.068|TWO_SIDED|95.0|0.97|2.53||P-value and 95% confidence interval for odds ratio were calculated from logistic regression model (including baseline value and treatment group as factors) for binary data for comparison of meloxicam group versus placebo.|Regression, Logistic|||\>=30% reduction (Week 8)||2.53|0.97|0.0680
72532244|NCT01430559|144593531|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.41||||0.0005|TWO_SIDED|95.0|1.47|3.94||P-value and 95% confidence interval for odds ratio were calculated from logistic regression model (including baseline value and treatment group as factors) for binary data for comparison of meloxicam group versus placebo.|Regression, Logistic|||\>=30% reduction (Week 12)||3.94|1.47|0.0005
72532245|NCT01430559|144593531|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.94||||0.1736|TWO_SIDED|95.0|0.75|5.01||P-value and 95% confidence interval for odds ratio were calculated from logistic regression model (including baseline value and treatment group as factors) for binary data for comparison of meloxicam group versus placebo.|Regression, Logistic|||\>=50% reduction (Week 2)||5.01|0.75|0.1736
72532246|NCT01430559|144593531|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.72||||0.1496|TWO_SIDED|95.0|0.82|3.59||P-value and 95% confidence interval for odds ratio were calculated from logistic regression model (including baseline value and treatment group as factors) for binary data for comparison of meloxicam group versus placebo.|Regression, Logistic|||\>=50% reduction (Week 4)||3.59|0.82|0.1496
72572326|NCT02912650|144671815|SUPERIORITY_OR_OTHER||CMH adjusted proportions|43.16|||<|0.001|TWO_SIDED|95.0|29.56|56.75|||Cochran-Mantel-Haenszel|||12 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||56.75|29.56|<0.001
72572327|NCT02912650|144671815|SUPERIORITY_OR_OTHER||CMH adjusted proportions|7.91||||0.087|TWO_SIDED|95.0|-1.15|16.97|||Cochran-Mantel-Haenszel|||12 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||16.97|-1.15|0.087
72572328|NCT02912650|144671816|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||p-value was calculated from CMH test with modified ridit scores, controlling for baseline categorical PSR and gender.||||<0.001
72626177|NCT00402987|144781741|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001||95.0||||"Analysis at 90 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.001
72626178|NCT00402987|144781741|SUPERIORITY_OR_OTHER_LEGACY|||||||0.022||95.0||||"Analysis at 90 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.022
72626179|NCT00402987|144781741|SUPERIORITY_OR_OTHER_LEGACY|||||||0.249||95.0||||"Analysis at 90 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.249
72626180|NCT00402987|144781741|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 1.75 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
72626181|NCT00402987|144781741|SUPERIORITY_OR_OTHER_LEGACY|||||||0.006||95.0||||"Analysis at 1.75 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.006
72532247|NCT01430559|144593531|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.12||||0.0171|TWO_SIDED|95.0|1.14|3.93||P-value and 95% confidence interval for odds ratio were calculated from logistic regression model (including baseline value and treatment group as factors) for binary data for comparison of meloxicam group versus placebo.|Regression, Logistic|||\>=50% reduction (Week 8)||3.93|1.14|0.0171
72532248|NCT01430559|144593531|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.77||||0.0004|TWO_SIDED|95.0|1.57|4.89||P-value and 95% confidence interval for odds ratio were calculated from logistic regression model (including baseline value and treatment group as factors) for binary data for comparison of meloxicam group versus placebo.|Regression, Logistic|||\>=50% reduction (Week 12)||4.89|1.57|0.0004
72532249|NCT01430559|144593532|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.06||0.0027|TWO_SIDED|95.0|-0.31|-0.07||P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.|ANCOVA|||Week 2||-0.07|-0.31|0.0027
72532250|NCT01430559|144593532|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.07||0.0308|TWO_SIDED|95.0|-0.3|-0.01||P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.|ANCOVA|||Week 4||-0.01|-0.30|0.0308
72532251|NCT01430559|144593532|SUPERIORITY_OR_OTHER_LEGACY|P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.|Least Squares Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.06||0.006|TWO_SIDED|95.0|-0.31|-0.05|||ANCOVA|||Week 8||-0.05|-0.31|0.0060
72532252|NCT01430559|144593532|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.07||0.0076|TWO_SIDED|95.0|-0.34|-0.05||P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.|ANCOVA|||Week 12||-0.05|-0.34|0.0076
72532253|NCT01430559|144593533|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.13||||0.2843|TWO_SIDED|95.0|0.53|8.5||P-value and 95% confidence interval for odds ratio were calculated from logistic regression model (including baseline value and treatment group as factors) for binary data for comparison of meloxicam group versus placebo.|Regression, Logistic|||Week 2||8.50|0.53|0.2843
72532254|NCT01430559|144593533|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.05||||0.105|TWO_SIDED|95.0|0.86|4.87||P-value and 95% confidence interval for odds ratio were calculated from logistic regression model (including baseline value and treatment group as factors) for binary data for comparison of meloxicam group versus placebo.|Regression, Logistic|||Week 4||4.87|0.86|0.1050
72532255|NCT01430559|144593533|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.16||||0.7861|TWO_SIDED|95.0|0.4|3.32||P-value and 95% confidence interval for odds ratio were calculated from logistic regression model (including baseline value and treatment group as factors) for binary data for comparison of meloxicam group versus placebo.|Regression, Logistic|||Week 8||3.32|0.40|0.7861
72532256|NCT01430559|144593533|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.71||||0.1873|TWO_SIDED|95.0|0.77|3.78||P-value and 95% confidence interval for odds ratio were calculated from logistic regression model (including baseline value and treatment group as factors) for binary data for comparison of meloxicam group versus placebo.|Regression, Logistic|||Week 12||3.78|0.77|0.1873
72532257|NCT01430559|144593534|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|1.38|STANDARD_ERROR_OF_MEAN|1.55||0.3738|TWO_SIDED|95.0|-1.67|4.42||P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.|ANCOVA|||General health||4.42|-1.67|0.3738
72532258|NCT01430559|144593534|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|5.94|STANDARD_ERROR_OF_MEAN|1.96||0.0028|TWO_SIDED|95.0|2.07|9.8||P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.|ANCOVA|||Physical functioning||9.80|2.07|0.0028
72532259|NCT01430559|144593534|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|8.16|STANDARD_ERROR_OF_MEAN|2.14||0.0002|TWO_SIDED|95.0|3.95|12.38||P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.|ANCOVA|||Role physical||12.38|3.95|0.0002
72626182|NCT00402987|144781741|SUPERIORITY_OR_OTHER_LEGACY|||||||0.205||95.0||||"Analysis at 1.75 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.205
72626183|NCT00402987|144781741|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 2 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
72626184|NCT00402987|144781741|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002||95.0||||"Analysis at 2 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.002
72626185|NCT00402987|144781741|SUPERIORITY_OR_OTHER_LEGACY|||||||0.186||95.0||||"Analysis at 2 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.186
72626186|NCT00402987|144781741|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 3 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
72532260|NCT01430559|144593534|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|7.36|STANDARD_ERROR_OF_MEAN|1.66|<|0.0001|TWO_SIDED|95.0|4.1|10.63||P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.|ANCOVA|||Bodily pain||10.63|4.10|<0.0001
72532261|NCT01430559|144593534|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|2.05|STANDARD_ERROR_OF_MEAN|1.64||0.2124|TWO_SIDED|95.0|-1.18|5.27||P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.|ANCOVA|||Vitality||5.27|-1.18|0.2124
72532262|NCT01430559|144593534|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|5.96|STANDARD_ERROR_OF_MEAN|2.1||0.005|TWO_SIDED|95.0|1.82|10.1||P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.|ANCOVA|||Social functioning||10.10|1.82|0.0050
72532263|NCT01430559|144593534|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|5.87|STANDARD_ERROR_OF_MEAN|2.24||0.0093|TWO_SIDED|95.0|1.46|10.28||P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.|ANCOVA|||Role emotional||10.28|1.46|0.0093
72532264|NCT01430559|144593534|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|0.57|STANDARD_ERROR_OF_MEAN|1.64||0.7274|TWO_SIDED|95.0|-2.66|3.81||P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.|ANCOVA|||Mental health||3.81|-2.66|0.7274
72532265|NCT01430559|144593534|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|0.94|STANDARD_ERROR_OF_MEAN|0.88||0.2819|TWO_SIDED|95.0|-0.78|2.67||P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.|ANCOVA|||Mental component aggregate||2.67|-0.78|0.2819
72532266|NCT01430559|144593534|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|2.57|STANDARD_ERROR_OF_MEAN|0.66||0.0001|TWO_SIDED|95.0|1.27|3.86||P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.|ANCOVA|||Physical component aggregate||3.86|1.27|0.0001
72532267|NCT01430559|144593535|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.6||||0.0014|TWO_SIDED|95.0|1.45|4.66||P-value and 95% confidence interval for odds ratio were calculated from logistic regression model (including baseline value and treatment group as factors) for binary data for comparison of meloxicam group versus placebo.|Regression, Logistic|||Mobility||4.66|1.45|0.0014
72532268|NCT01430559|144593535|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.51||||0.108|TWO_SIDED|95.0|0.91|2.48||P-value and 95% confidence interval for odds ratio were calculated from logistic regression model (including baseline value and treatment group as factors) for binary data for comparison of meloxicam group versus placebo.|Regression, Logistic|||Self-care||2.48|0.91|0.1080
72532269|NCT01430559|144593535|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.06||||0.0119|TWO_SIDED|95.0|1.17|3.62||P-value and 95% confidence interval for odds ratio were calculated from logistic regression model (including baseline value and treatment group as factors) for binary data for comparison of meloxicam group versus placebo.|Regression, Logistic|||Usual activities||3.62|1.17|0.0119
72532270|NCT01430559|144593535|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.62||||0.0887|TWO_SIDED|95.0|0.93|2.83||P-value and 95% confidence interval for odds ratio were calculated from logistic regression model (including baseline value and treatment group as factors) for binary data for comparison of meloxicam group versus placebo.|Regression, Logistic|||Pain/discomfort||2.83|0.93|0.0887
72532271|NCT01430559|144593535|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.37||||0.2466|TWO_SIDED|95.0|0.8|2.33||P-value and 95% confidence interval for odds ratio were calculated from logistic regression model (including baseline value and treatment group as factors) for binary data for comparison of meloxicam group versus placebo.|Regression, Logistic|||Anxiety/depression||2.33|0.80|0.2466
72532272|NCT01430559|144593536|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.14||0.0367|TWO_SIDED|95.0|-0.58|-0.02||P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.|ANCOVA|||Week 2||-0.02|-0.58|0.0367
72532273|NCT01430559|144593536|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.32|STANDARD_ERROR_OF_MEAN|0.17||0.0652|TWO_SIDED|95.0|-0.65|0.02||P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.|ANCOVA|||Week 4||0.02|-0.65|0.0652
72532274|NCT01430559|144593536|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.44|STANDARD_ERROR_OF_MEAN|0.19||0.02|TWO_SIDED|95.0|-0.81|-0.07||P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.|ANCOVA|||Week 8||-0.07|-0.81|0.0200
72532275|NCT01430559|144593536|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.63|STANDARD_ERROR_OF_MEAN|0.2||0.0016|TWO_SIDED|95.0|-1.02|-0.24||P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.|ANCOVA|||Week 12||-0.24|-1.02|0.0016
72626187|NCT00402987|144781741|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 3 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
72626188|NCT00402987|144781741|SUPERIORITY_OR_OTHER_LEGACY|||||||0.179||95.0||||"Analysis at 3 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.179
72532276|NCT01177943|144593537|NON_INFERIORITY_OR_EQUIVALENCE|80-125% was used for bioequivalence (BE) criteria in terms of geometric means.|Ratio of Geometric LS Mean values|0.945|||||TWO_SIDED|90.0|0.858|1.04|||ANOVA|||||1.04|0.858|
72572329|NCT02912650|144671816|SUPERIORITY_OR_OTHER|||||||0.004|||||||Cochran-Mantel-Haenszel|||p-value was calculated from CMH test with modified ridit scores, controlling for baseline categorical PSR and gender.||||0.004
72572330|NCT02912650|144671816|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||p-value was calculated from CMH test with modified ridit scores, controlling for baseline categorical PSR and gender.||||<0.001
72572331|NCT02912650|144671816|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||p-value was calculated from CMH test with modified ridit scores, controlling for baseline categorical PSR and gender.||||<0.001
72572332|NCT02912650|144671816|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||p-value was calculated from CMH test with modified ridit scores, controlling for baseline categorical PSR and gender.||||<0.001
72572333|NCT02912650|144671816|SUPERIORITY_OR_OTHER|||||||0.003|||||||Cochran-Mantel-Haenszel|||p-value was calculated from CMH test with modified ridit scores, controlling for baseline categorical PSR and gender.||||0.003
72572334|NCT01104779|144671848|SUPERIORITY||Mean Difference (Final Values)|-6.8||||0.0029|TWO_SIDED|95.0|-11.3|-2.4|||ANCOVA||Cariprazine 3-6 mg/day vs Placebo|||-2.4|-11.3|0.0029
72572335|NCT01104779|144671848|SUPERIORITY||Mean Difference (Final Values)|-9.9|||<|0.0001|TWO_SIDED|95.0|-14.5|-5.3|||ANCOVA||Cariprazine 6-9 mg/day vs Placebo|||-5.3|-14.5|<0.0001
72532277|NCT01177943|144593538|NON_INFERIORITY_OR_EQUIVALENCE|80-125% was used for bioequivalence (BE) criteria in terms of the ratio of geometric means.|Ratio of AUC(0-tlast) values|1.03|||||TWO_SIDED|90.0|1.0|1.07|||ANOVA|||||1.07|1.00|
72532278|NCT00808665|144593539|SUPERIORITY|||||||0.36|||||||Wilcoxon (Mann-Whitney)|||||||0.36
72532279|NCT03319160|144593540|OTHER||Incidence per 100 patient-years|7.5|STANDARD_DEVIATION|2.74|||TWO_SIDED|95.0|6.3|8.7|||||"Poisson distribution assumed due to the infrequent nature of the events. Number of appropriate shock events: 19 (17 subjects had one appropriate shock event, one subject had two appropriate shock events).~Length of exposure: 253 patient-years."|||8.7|6.3|
72532280|NCT03319160|144593542|OTHER||Incidence per 100 patient-years|3.2|STANDARD_DEVIATION|1.78|||TWO_SIDED|95.0|1.9|4.4|||||||Poisson distribution assumed due to the infrequent nature of the events. Number of inappropriately shocked events: 8. Length of exposure: 253 patient-years.|4.4|1.9|
72572336|NCT01104779|144671849|SUPERIORITY||Mean Difference (Final Values)|-0.3||||0.0115|TWO_SIDED|95.0|-0.6|-0.1|||ANCOVA||Cariprazine 3-6 mg/day vs Placebo|||-0.1|-0.6|0.0115
72572337|NCT01104779|144671849|SUPERIORITY||Mean Difference (Final Values)|-0.5|||<|0.0001|TWO_SIDED|95.0|-0.8|-0.3|||ANCOVA||Cariprazine 6-9 mg/day vs Placebo|||-0.3|-0.8|<0.0001
72572338|NCT03982199|144671850|SUPERIORITY||Event Rate|80.0||||4e-05|TWO_SIDED|94.211|52.2|92.9|||Poisson regression|||Case Definition 1||92.9|52.2|0.00004
72572339|NCT03982199|144671850|SUPERIORITY||Event Rate|75.0||||1e-05|TWO_SIDED|94.211|50.1|88.5|||Poisson regression|||Case Definition 2||88.5|50.1|0.00001
72572340|NCT03982199|144671850|SUPERIORITY||Event Rate|69.8||||4e-05|TWO_SIDED|94.211|43.7|84.7|||Poisson regression|||Case Definition 3||84.7|43.7|0.00004
72532281|NCT02347345|144593559|OTHER|Descriptive pilot study. Not relevant.||||||0.07|||||||Kruskal-Wallis|||||||0.07
72532282|NCT00643851|144593567|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.86|STANDARD_ERROR_OF_MEAN|0.1243|<|0.0001|TWO_SIDED|95.0|-1.11|-0.62||Primary endpoint was tested at alpha=0.05; significance was claimed only if DAPA 5MG + MET was superior to both controls.|ANCOVA|||||-0.62|-1.11|<0.0001
72532283|NCT00643851|144593567|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|0.1245|<|0.0001|TWO_SIDED|95.0|-0.94|-0.45||Primary endpoint was tested at alpha=0.05; significance was claimed only if DAPA 5MG + MET is superior to both controls.|ANCOVA|||||-0.45|-0.94|<0.0001
72532284|NCT00643851|144593568|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-19.1|STANDARD_ERROR_OF_MEAN|3.883|<|0.0001|TWO_SIDED|95.0|-26.7|-11.4||Secondary endpoints were tested following a sequential testing procedure at alpha=0.05. Significance was claimed only if DAPA 5MG + MET is superior to both controls.|ANCOVA|||||-11.4|-26.7|<0.0001
72572341|NCT05011123|144671939|NON_INFERIORITY|The non-inferiority was demonstrated if the lower limit of the 2-sided 95% confidence interval (CI) was \>-5%|Difference in percentage of participants|-1.2|||||TWO_SIDED|95.0|-3.4|1.8|||||95% CI of the difference was calculated from the Wilson score method without continuity correction.|||1.8|-3.4|
72572342|NCT05011123|144671940|NON_INFERIORITY|The non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI was \>-5%|Difference in percentage of participants|-0.9|||||TWO_SIDED|95.0|-4.0|3.0|||||95% CI of the difference was calculated from the Wilson score method without continuity correction.|||3.0|-4.0|
72626189|NCT00402987|144781741|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 4 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
72626190|NCT00402987|144781741|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 4 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
72532285|NCT00643851|144593568|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-27.5|STANDARD_ERROR_OF_MEAN|3.897|<|0.0001|TWO_SIDED|95.0|-35.1|-19.8||Secondary endpoints were tested following a sequential testing procedure at alpha=0.05. Significance was claimed only if DAPA 5MG + MET is superior to both controls.|ANCOVA|||||-19.8|-35.1|<0.0001
72532286|NCT00643851|144593569|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|29.9|STANDARD_ERROR_OF_MEAN|4.633|<|0.0001|TWO_SIDED|95.0|20.8|39.0||Secondary endpoints were tested following a sequential testing procedure at alpha=0.05. Significance was claimed only if DAPA 5MG + MET is superior to both controls.|modified logistic regression|||||39.0|20.8|<0.0001
72572343|NCT04221789|144671952|OTHER|differences in proportions|Risk Ratio (RR)|1.12||||0.049|TWO_SIDED|95.0|1.02|1.2||Statistical significance threshold p \<0.05|Chi-squared|||Ho no difference in treatment success between groups. The study was originally powered to detect a 15% difference between groups||1.20|1.02|0.049
72572344|NCT04221789|144671953|OTHER|comparison of proportions and relative risk with 95% CI|Risk Ratio (RR)|0.7|||<|0.043|TWO_SIDED|95.0|0.5|0.97||statistical significance if p value \<0.05|Chi-squared||intervention / control|Ho No difference between arms. 80% power to detect a 10% difference||0.97|0.50|<0.043
72532287|NCT00643851|144593569|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|17.8|STANDARD_ERROR_OF_MEAN|4.947||0.0003|TWO_SIDED|95.0|8.1|27.4||Secondary endpoints were tested following a sequential testing procedure at alpha=0.05. Significance was claimed only if DAPA 5MG + MET is superior to both controls.|ANCOVA|||||27.4|8.1|0.0003
72532288|NCT00643851|144593570|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.34|STANDARD_ERROR_OF_MEAN|0.1938|<|0.0001|TWO_SIDED|95.0|-1.72|-0.96||Secondary endpoints were tested following a sequential testing procedure at alpha=0.05. Significance was claimed only if DAPA 5MG + MET is superior to both controls.|ANCOVA|||||-0.96|-1.72|<0.0001
72532289|NCT00643851|144593570|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.19|STANDARD_ERROR_OF_MEAN|0.1912|<|0.0001|TWO_SIDED|95.0|-1.57|-0.82||Secondary endpoints were tested following a sequential testing procedure at alpha=0.05. Significance was claimed only if DAPA 5MG + MET is superior to both controls.|ANCOVA|||||-0.82|-1.57|<0.0001
72532290|NCT00643851|144593571|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.3388||0.8769|TWO_SIDED|95.0|-0.72|0.61||Secondary endpoints were tested following a sequential testing procedure at alpha=0.05. Significance was claimed only if DAPA 5MG + MET is superior to both controls.|ANCOVA|||||0.61|-0.72|0.8769
72532291|NCT00643851|144593571|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.37|STANDARD_ERROR_OF_MEAN|0.3399|<|0.0001|TWO_SIDED|95.0|-2.04|-0.71||Secondary endpoints were tested following a sequential testing procedure at alpha=0.05. Significance was claimed only if DAPA 5MG + MET is superior to both controls.|ANCOVA|||||-0.71|-2.04|<0.0001
72532292|NCT00643851|144593572|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.16|STANDARD_ERROR_OF_MEAN|0.4191|||TWO_SIDED|95.0|-0.98|0.66||Secondary endpoints were tested following a sequential testing procedure at alpha=0.05. Significance was claimed only if DAPA 5MG + MET is superior to both controls.|ANCOVA|||||0.66|-0.98|
72532293|NCT00643851|144593572|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.57|STANDARD_ERROR_OF_MEAN|0.4201|||TWO_SIDED|95.0|-2.4|-0.74||Secondary endpoints were tested following a sequential testing procedure at alpha=0.05. Significance was claimed only if DAPA 5MG + MET is superior to both controls.|ANCOVA|||||-0.74|-2.40|
72532294|NCT04557189|144593577|SUPERIORITY||Adjusted Treatment Difference|0.241|||||TWO_SIDED|95.0|0.031|0.452|||||Adjusted treatment difference between TAK-951, ondansetron, associated confidence intervals: based on CMH method, adjusting for number of Apfel risk factors (3/4), or exact unconditional confidence limits for treatment difference if numerator is ≤5.|||0.452|0.031|
72532295|NCT04557189|144593578|SUPERIORITY||Adjusted Treatment Difference|0.175|||||TWO_SIDED|95.0|-0.044|0.394|||||||Adjusted treatment difference between TAK-951, ondansetron, associated confidence intervals: based on Cochran-Mantel-Haenszel (CMH) method, adjusting for number of Apfel risk factors (3/4), or exact unconditional confidence limits for treatment difference if numerator is ≤5.|0.394|-0.044|
72532296|NCT04557189|144593579|SUPERIORITY||Adjusted Treatment Difference|-0.094|||||TWO_SIDED|95.0|-0.253|0.059|||||Adjusted treatment difference between TAK-951, ondansetron, associated confidence intervals: based on CMH method, adjusting for number of Apfel risk factors (3/4), or exact unconditional confidence limits for treatment difference if numerator is ≤5.|||0.059|-0.253|
72532297|NCT04557189|144593580|SUPERIORITY||Adjusted Treatment Difference|-0.141|||||TWO_SIDED|95.0|-0.316|0.033|||||Adjusted treatment difference between TAK-951, ondansetron, associated confidence intervals: based on CMH method, adjusting for number of Apfel risk factors (3/4), or exact unconditional confidence limits for treatment difference if numerator is ≤5.|||0.033|-0.316|
72532298|NCT04557189|144593581|SUPERIORITY||Adjusted Treatment Difference|0.191|||||TWO_SIDED|95.0|-0.029|0.41|||||Adjusted treatment difference between TAK-951, ondansetron, associated confidence intervals: based on CMH method, adjusting for number of Apfel risk factors (3/4), or exact unconditional confidence limits for treatment difference if numerator is ≤5.|||0.410|-0.029|
72532299|NCT04557189|144593582|SUPERIORITY||Adjusted Treatment Difference|0.146|||||TWO_SIDED|95.0|-0.073|0.365|||||Adjusted treatment difference between TAK-951, ondansetron, associated confidence intervals: based on CMH method, adjusting for number of Apfel risk factors (3/4), or exact unconditional confidence limits for treatment difference if numerator is ≤5.|||0.365|-0.073|
72532300|NCT04557189|144593583|SUPERIORITY||Adjusted Treatment Difference|-0.234|||||TWO_SIDED|95.0|-0.448|-0.019|||||Adjusted treatment difference between TAK-951, ondansetron, associated confidence intervals: based on CMH method, adjusting for number of Apfel risk factors (3/4), or exact unconditional confidence limits for treatment difference if numerator is ≤5.|||-0.019|-0.448|
72532301|NCT04557189|144593584|SUPERIORITY||Hazard Ratio (HR)|0.393|||||TWO_SIDED|95.0|0.122|1.259|||||The hazard ratio is derived from a Cox proportional hazard model with treatment group and the number of Apfel risk factors (3 or 4) as independent variables.|||1.259|0.122|
72532302|NCT04557189|144593585|SUPERIORITY||Difference in LSM Estimates|0.188|||||TWO_SIDED|95.0|-0.402|0.777||||||30 Minutes Post Surgery|From MMRM analysis over all post-randomization timepoints, with the Peak VRS score as the outcome, treatment group, timepoint, number of Apfel risk factors and treatment-by-timepoint interaction as fixed effects and participant as random effect with unstructured covariance structure for observed data up to 24 hours post surgery.|0.777|-0.402|
72532303|NCT04557189|144593585|SUPERIORITY||Difference in LSM Estimates|0.401|||||TWO_SIDED|95.0|-0.258|1.059||||||1 Hour Post Surgery|From MMRM analysis over all post-randomization timepoints, with the Peak VRS score as the outcome, treatment group, timepoint, number of Apfel risk factors and treatment-by-timepoint interaction as fixed effects and participant as random effect with unstructured covariance structure for observed data up to 24 hours post surgery.|1.059|-0.258|
72532304|NCT04557189|144593585|SUPERIORITY||Difference in LSM Estimates|0.265|||||TWO_SIDED|95.0|0.0|0.786||||||2 Hours Post Surgery|From MMRM analysis over all post-randomization timepoints, with the Peak VRS score as the outcome, treatment group, timepoint, number of Apfel risk factors and treatment-by-timepoint interaction as fixed effects and participant as random effect with unstructured covariance structure for observed data up to 24 hours post surgery.|0.786|0|
72626191|NCT00402987|144781741|SUPERIORITY_OR_OTHER_LEGACY|||||||0.259||95.0||||"Analysis at 4 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.259
72626192|NCT00402987|144781741|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 5 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
72532305|NCT04557189|144593585|SUPERIORITY||Difference in LSM Estimates|0.097|||||TWO_SIDED|95.0|-0.093|0.286||||||6 Hours Post Surgery|From MMRM analysis over all post-randomization timepoints, with the Peak VRS score as the outcome, treatment group, timepoint, number of Apfel risk factors and treatment-by-timepoint interaction as fixed effects and participant as random effect with unstructured covariance structure for observed data up to 24 hours post surgery.|0.286|-0.093|
72532306|NCT04557189|144593585|SUPERIORITY||Difference in LSM Estimates|-0.203|||||TWO_SIDED|95.0|-0.575|0.17||||||24 Hours Post Surgery|From MMRM analysis over all post-randomization timepoints, with the Peak VRS score as the outcome, treatment group, timepoint, number of Apfel risk factors and treatment-by-timepoint interaction as fixed effects and participant as random effect with unstructured covariance structure for observed data up to 24 hours post surgery.|0.170|-0.575|
72532307|NCT04557189|144593586|SUPERIORITY||Adjusted Treatment Difference|0.146|||||TWO_SIDED|95.0|-0.073|0.365|||||Adjusted treatment difference between TAK-951, ondansetron, associated confidence intervals: based on CMH method, adjusting for number of Apfel risk factors (3/4), or exact unconditional confidence limits for treatment difference if numerator is ≤5.|||0.365|-0.073|
72532308|NCT01731600|144593605|OTHER||Incidence rate|0.0|||||ONE_SIDED|97.5||0.067|||||The incidence of inhibitory antibodies was calculated as number of patients with inhibitors during the main phase of the trial divided by number of patients in the main phase of the trial.|A one-sided, upper 97.5% confidence limit was provided based on an exact calculation in the binomial distribution.||0.067||
72532309|NCT00465894|144593622|SUPERIORITY|||||||0.45|||||||t-test, 2 sided|||||||.45
72532310|NCT01728454|144593811|SUPERIORITY|||||||0.036|||||||Wilcoxon Rank- Sum Test|||On-Drug Cycle 1||||0.0360
72532311|NCT01728454|144593811|SUPERIORITY|||||||0.1087|||||||Wilcoxon Rank- Sum Test|||On-Drug Cycle 1||||0.1087
72532312|NCT01728454|144593811|SUPERIORITY|||||||0.2263|||||||Wilcoxon Rank- Sum Test|||Off-Drug Cycle 1||||0.2263
72532313|NCT01728454|144593811|SUPERIORITY|||||||0.5375|||||||Wilcoxon Rank- Sum Test|||Off-Drug Cycle 1||||0.5375
72532314|NCT01728454|144593812|SUPERIORITY|||||||0.1017|||||||Wilcoxon Rank- Sum Test|||On-Drug Cycle 1||||0.1017
72532315|NCT01728454|144593812|SUPERIORITY|||||||0.1927|||||||Wilcoxon Rank- Sum Test|||On-Drug Cycle 1||||0.1927
72532316|NCT01728454|144593812|SUPERIORITY|||||||0.1017|||||||Wilcoxon Rank- Sum Test|||Off-Drug Cycle 1||||0.1017
72532317|NCT01728454|144593812|SUPERIORITY|||||||0.1927|||||||Wilcoxon Rank- Sum Test|||Off-Drug Cycle 1||||0.1927
72532318|NCT01728454|144593813|SUPERIORITY|||||||0.7508|||||||Wilcoxon Rank- Sum Test|||On-Drug Cycle 1||||0.7508
72532319|NCT01728454|144593813|SUPERIORITY|||||||0.5507|||||||Wilcoxon Rank- Sum Test|||On-Drug Cycle 1||||0.5507
72532320|NCT01728454|144593813|SUPERIORITY|||||||0.3993|||||||Wilcoxon Rank- Sum Test|||Off-Drug Cycle 1||||0.3993
72532321|NCT01728454|144593813|SUPERIORITY|||||||0.5821|||||||Wilcoxon Rank- Sum Test|||Off-Drug Cycle 1||||0.5821
72532322|NCT01728454|144593814|SUPERIORITY|||||||0.7507|||||||Wilcoxon Rank- Sum Test|||On-Drug Cycle||||0.7507
72532323|NCT01728454|144593814|SUPERIORITY|||||||0.8919|||||||Wilcoxon Rank- Sum Test|||On-Drug Cycle||||0.8919
72532324|NCT01728454|144593815|SUPERIORITY|||||||0.478|||||||Wilcoxon Rank- Sum Test|||On-Drug Cycle||||0.4780
72532325|NCT01728454|144593815|SUPERIORITY|||||||0.2354|||||||Wilcoxon Rank- Sum Test|||On-Drug Cycle||||0.2354
72532326|NCT01728454|144593816|SUPERIORITY|||||||0.114|||||||Wilcoxon Rank- Sum Test|||On-Drug Cycle||||0.1140
72532327|NCT01728454|144593816|SUPERIORITY|||||||0.1636|||||||Wilcoxon Rank- Sum Test|||On-Drug Cycle||||0.1636
72532328|NCT01728454|144593817|SUPERIORITY|||||||0.114|||||||Wilcoxon Rank- Sum Test|||On-Drug Cycle||||0.1140
72532329|NCT01728454|144593817|SUPERIORITY|||||||0.0733|||||||Wilcoxon Rank- Sum Test|||On-Drug Cycle||||0.0733
72532330|NCT01728454|144593818|SUPERIORITY|||||||0.1253|||||||Wilcoxon Rank- Sum Test|||On-Drug Cycle||||0.1253
72532331|NCT01728454|144593818|SUPERIORITY|||||||0.3442|||||||Wilcoxon Rank- Sum Test|||On-Drug Cycle||||0.3442
72532332|NCT01728454|144593819|SUPERIORITY|||||||0.0303|||||||Wilcoxon Rank- Sum Test|||On-Drug Cycle||||0.0303
72532333|NCT01728454|144593819|SUPERIORITY|||||||0.2864|||||||Wilcoxon Rank- Sum Test|||On-Drug Cycle||||0.2864
72532334|NCT01728454|144593820|SUPERIORITY|||||||0.4365|||||||Wilcoxon Rank- Sum Test|||PTS: LOCF Cycle 1||||0.4365
72532335|NCT01728454|144593820|SUPERIORITY|||||||0.1302|||||||Wilcoxon Rank- Sum Test|||PTS: LOCF Cycle 1||||0.1302
72532336|NCT01728454|144593820|SUPERIORITY|||||||0.3591|||||||Wilcoxon Rank- Sum Test|||PTS: ODI Cycle 1||||0.3591
72532337|NCT01728454|144593820|SUPERIORITY|||||||0.0872|||||||Wilcoxon Rank- Sum Test|||PTS: ODI Cycle 1||||0.0872
72532338|NCT01728454|144593820|SUPERIORITY|||||||0.4814|||||||Wilcoxon Rank- Sum Test|||IS: LOCF Cycle 1||||0.4814
72532339|NCT01728454|144593820|SUPERIORITY|||||||0.9162|||||||Wilcoxon Rank- Sum Test|||IS: LOCF Cycle 1||||0.9162
72532340|NCT01728454|144593820|SUPERIORITY|||||||0.6607|||||||Wilcoxon Rank- Sum Test|||IS: ODI Cycle 1||||0.6607
72532341|NCT01728454|144593820|SUPERIORITY|||||||0.9527|||||||Wilcoxon Rank- Sum Test|||IS: ODI Cycle 1||||0.9527
72532342|NCT01728454|144593821|SUPERIORITY|||||||0.2812|||||||Wilcoxon Rank- Sum Test|||LOCF Cycle 1||||0.2812
72532343|NCT01728454|144593821|SUPERIORITY|||||||0.5858|||||||Wilcoxon Rank- Sum Test|||LOCF Cycle 1||||0.5858
72532344|NCT01728454|144593821|SUPERIORITY|||||||0.4116|||||||Wilcoxon Rank- Sum Test|||ODI Cycle 1||||0.4116
72532345|NCT01728454|144593821|SUPERIORITY|||||||0.4252|||||||Wilcoxon Rank- Sum Test|||ODI Cycle 1||||0.4252
72532346|NCT01728454|144593822|SUPERIORITY|||||||0.6131|||||||Wilcoxon Rank- Sum Test|||SAP: On-Drug Cycle 1||||0.6131
72532347|NCT01728454|144593822|SUPERIORITY|||||||0.7881|||||||Wilcoxon Rank- Sum Test|||SAP: On-Drug Cycle 1||||0.7881
72532348|NCT01728454|144593822|SUPERIORITY|||||||0.9376|||||||Wilcoxon Rank- Sum Test|||SAP: Off-Drug Cycle 1||||0.9376
72532349|NCT01728454|144593822|SUPERIORITY|||||||0.6552|||||||Wilcoxon Rank- Sum Test|||SAP: Off-Drug Cycle 1||||0.6552
72532350|NCT01728454|144593822|SUPERIORITY|||||||0.7143|||||||Wilcoxon Rank- Sum Test|||EP: On-Drug Cycle 1||||0.7143
72532351|NCT01728454|144593822|SUPERIORITY|||||||0.2985|||||||Wilcoxon Rank- Sum Test|||EP: On-Drug Cycle 1||||0.2985
72532352|NCT01728454|144593822|SUPERIORITY|||||||0.3162|||||||Wilcoxon Rank- Sum Test|||EP: Off-Drug Cycle 1||||0.3162
72532353|NCT01728454|144593822|SUPERIORITY|||||||0.7503|||||||Wilcoxon Rank- Sum Test|||EP: Off-Drug Cycle 1||||0.7503
72532354|NCT01190839|144593823|SUPERIORITY_OR_OTHER|||||||0.097||||||p-value was based on the Cochran-Mantel-Haenszel chi-square test stratified by the number of risk factors for recurrence of active CD and baseline use of an immunomodulator.|Cochran-Mantel-Haenszel chi-square test|||||||0.097
72626193|NCT00402987|144781741|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 5 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
72626194|NCT00402987|144781741|SUPERIORITY_OR_OTHER_LEGACY|||||||0.393||95.0||||"Analysis at 5 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.393
72626195|NCT00402987|144781741|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 6 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
72626196|NCT00402987|144781741|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 6 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
72532355|NCT01190839|144593824|SUPERIORITY_OR_OTHER||||||<|0.001||||||p-value was based on the Cochran-Mantel-Haenszel chi-square test stratified by the number of risk factors for recurrence of active CD and baseline use of an immunomodulator.|Cochran-Mantel-Haenszel chi-square test|||||||<0.001
72532356|NCT01190839|144593825|SUPERIORITY_OR_OTHER|||||||0.098||||||p-value was based on the Cochran-Mantel-Haenszel chi-square test stratified by the number of risk factors for recurrence of active CD and baseline use of an immunomodulator.|Cochran-Mantel-Haenszel chi-square test|||||||0.098
72532357|NCT01362062|144593853|SUPERIORITY_OR_OTHER||||||=|0.001|TWO_SIDED||||||Paired t-test|||Statistical analysis for CFB at Visit 3.||||=0.001
72532358|NCT01362062|144593853|SUPERIORITY_OR_OTHER||||||=|0.001|TWO_SIDED||||||Paired t-test|||Statistical analysis for CFB at Visit 4.||||=0.001
72532359|NCT01362062|144593853|SUPERIORITY_OR_OTHER||||||=|0.001|TWO_SIDED||||||Paired t-test|||Statistical analysis for CFB at Visit 5.||||=0.001
72532360|NCT01362062|144593853|SUPERIORITY_OR_OTHER||||||=|0.001|TWO_SIDED||||||Paired t-test|||Statistical analysis for CFB at Visit 6.||||=0.001
72532361|NCT01362062|144593853|SUPERIORITY_OR_OTHER||||||=|0.001|TWO_SIDED||||||Paired t-test|||Statistical analysis for CFB at Visit 7.||||=0.001
72532362|NCT01362062|144593853|SUPERIORITY_OR_OTHER||||||=|0.001|TWO_SIDED||||||Paired t-test|||Statistical analysis for CFB at Visit 8.||||=0.001
72532363|NCT01362062|144593853|SUPERIORITY_OR_OTHER||||||=|0.001|TWO_SIDED||||||Paired t-test|||Statistical analysis for CFB at Visit 9.||||=0.001
72532364|NCT01362062|144593853|SUPERIORITY_OR_OTHER||||||=|0.001|TWO_SIDED||||||Paired t-test|||Statistical analysis for CFB at Visit 10.||||=0.001
72532365|NCT01362062|144593853|SUPERIORITY_OR_OTHER||||||=|0.001|TWO_SIDED||||||Paired t-test|||Statistical analysis for CFB at Visit 11.||||=0.001
72532366|NCT01362062|144593853|SUPERIORITY_OR_OTHER||||||=|0.001|TWO_SIDED||||||Paired t-test|||Statistical analysis for CFB at Visit 12.||||=0.001
72532367|NCT01362062|144593853|SUPERIORITY_OR_OTHER||||||=|0.001|TWO_SIDED||||||Paired t-test|||Statistical analysis for CFB at Visit 13.||||=0.001
72626197|NCT00402987|144781741|SUPERIORITY_OR_OTHER_LEGACY|||||||0.512||95.0||||"Analysis at 6 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.512
72626198|NCT00402987|144781742|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 7 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
72626199|NCT00402987|144781742|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 7 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
72626200|NCT00402987|144781742|SUPERIORITY_OR_OTHER_LEGACY|||||||0.026||95.0||||"Analysis at 7 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.026
72532368|NCT01362062|144593854|SUPERIORITY_OR_OTHER||||||=|0.003|TWO_SIDED||||||Paired t-test|||Statistical analysis for CFB at Visit 3.||||=0.003
72532369|NCT01362062|144593854|SUPERIORITY_OR_OTHER||||||=|0.005|TWO_SIDED||||||Paired t-test|||Statistical analysis for CFB at Visit 4.||||=0.005
72532370|NCT01362062|144593854|SUPERIORITY_OR_OTHER||||||=|0.002|TWO_SIDED||||||Paired t-test|||Statistical analysis for CFB at Visit 5.||||=0.002
72532371|NCT01362062|144593854|SUPERIORITY_OR_OTHER||||||=|0.014|TWO_SIDED||||||Paired t-test|||Statistical analysis for CFB at Visit 6.||||=0.014
72532372|NCT01362062|144593854|SUPERIORITY_OR_OTHER||||||=|0.001|TWO_SIDED||||||Paired t-test|||Statistical analysis for CFB at Visit 7.||||=0.001
72532373|NCT01362062|144593854|SUPERIORITY_OR_OTHER||||||=|0.008|TWO_SIDED||||||Paired t-test|||Statistical analysis for CFB at Visit 8.||||=0.008
72532374|NCT01362062|144593854|SUPERIORITY_OR_OTHER||||||=|0.014|TWO_SIDED||||||Paired t-test|||Statistical analysis for CFB at Visit 9.||||=0.014
72532375|NCT01362062|144593854|SUPERIORITY_OR_OTHER||||||=|0.009|TWO_SIDED||||||Paired t-test|||Statistical analysis for CFB at Visit 10.||||=0.009
72532376|NCT01362062|144593854|SUPERIORITY_OR_OTHER||||||=|0.001|TWO_SIDED||||||Paired t-test|||Statistical analysis for CFB at Visit 11.||||=0.001
72532377|NCT01362062|144593854|SUPERIORITY_OR_OTHER||||||=|0.001|TWO_SIDED||||||Paired t-test|||Statistical analysis for CFB at Visit 12.||||=0.001
72532378|NCT01362062|144593854|SUPERIORITY_OR_OTHER||||||=|0.001|TWO_SIDED||||||Paired t-test|||Statistical analysis for CFB at Visit 13.||||=0.001
72532379|NCT01362062|144593855|SUPERIORITY_OR_OTHER||||||=|0.002|TWO_SIDED||||||Wilcoxon sign rank test|||Statistical analysis for CFB at Visit 3.||||=0.002
72532380|NCT01362062|144593855|SUPERIORITY_OR_OTHER||||||=|0.001|TWO_SIDED||||||Wilcoxon sign rank test|||Statistical analysis for CFB at Visit 4.||||=0.001
72532381|NCT01362062|144593855|SUPERIORITY_OR_OTHER||||||=|0.002|TWO_SIDED||||||Wilcoxon sign rank test|||Statistical analysis for CFB at Visit 5.||||=0.002
72532382|NCT01362062|144593855|SUPERIORITY_OR_OTHER||||||=|0.001|TWO_SIDED||||||Wilcoxon sign rank test|||Statistical analysis for CFB at Visit 6.||||=0.001
72532383|NCT01362062|144593855|SUPERIORITY_OR_OTHER||||||=|0.001|TWO_SIDED||||||Wilcoxon sign rank test|||Statistical analysis for CFB at Visit 7.||||=0.001
72532384|NCT01362062|144593855|SUPERIORITY_OR_OTHER||||||=|0.001|TWO_SIDED||||||Wilcoxon sign rank test|||Statistical analysis for CFB at Visit 8.||||=0.001
72626201|NCT00402987|144781742|SUPERIORITY_OR_OTHER_LEGACY|||||||0.463||95.0||||"Analysis at 7 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.463
72626202|NCT00402987|144781742|SUPERIORITY_OR_OTHER_LEGACY|||||||0.131||95.0||||"Analysis at 7 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.131
72532385|NCT01362062|144593855|SUPERIORITY_OR_OTHER||||||=|0.001|TWO_SIDED||||||Wilcoxon sign rank test|||Statistical analysis for CFB at Visit 9.||||=0.001
72532386|NCT01362062|144593855|SUPERIORITY_OR_OTHER||||||=|0.001|TWO_SIDED||||||Wilcoxon sign rank test|||Statistical analysis for CFB at Visit 10.||||=0.001
72532387|NCT01362062|144593855|SUPERIORITY_OR_OTHER||||||=|0.001|TWO_SIDED||||||Wilcoxon sign rank test|||Statistical analysis for CFB at Visit 11.||||=0.001
72532388|NCT01362062|144593855|SUPERIORITY_OR_OTHER||||||=|0.001|TWO_SIDED||||||Wilcoxon sign rank test|||Statistical analysis for CFB at Visit 12.||||=0.001
72532389|NCT01362062|144593855|SUPERIORITY_OR_OTHER||||||=|0.001|TWO_SIDED||||||Wilcoxon sign rank test|||Statistical analysis for CFB at Visit 13.||||=0.001
72532390|NCT01362062|144593856|SUPERIORITY_OR_OTHER||||||=|0.001|TWO_SIDED||||||Wilcoxon sign rank test|||Statistical analysis for CFB at Visit 3.||||=0.001
72532391|NCT01362062|144593856|SUPERIORITY_OR_OTHER||||||=|0.001|TWO_SIDED||||||Wilcoxon sign rank test|||Statistical analysis for CFB at Visit 4.||||=0.001
72532392|NCT01362062|144593856|SUPERIORITY_OR_OTHER||||||=|0.001|TWO_SIDED||||||Wilcoxon sign rank test|||Statistical analysis for CFB at Visit 5.||||=0.001
72532393|NCT01362062|144593856|SUPERIORITY_OR_OTHER||||||=|0.001|TWO_SIDED||||||Wilcoxon sign rank test|||Statistical analysis for CFB at Visit 6.||||=0.001
72532394|NCT01362062|144593856|SUPERIORITY_OR_OTHER||||||=|0.001|TWO_SIDED||||||Wilcoxon sign rank test|||Statistical analysis for CFB at Visit 7.||||=0.001
72532395|NCT01362062|144593856|SUPERIORITY_OR_OTHER||||||=|0.001|TWO_SIDED||||||Wilcoxon sign rank test|||Statistical analysis for CFB at Visit 8.||||=0.001
72532396|NCT01362062|144593856|SUPERIORITY_OR_OTHER||||||=|0.001|TWO_SIDED||||||Wilcoxon sign rank test|||Statistical analysis for CFB at Visit 9.||||=0.001
72532397|NCT01362062|144593856|SUPERIORITY_OR_OTHER||||||=|0.001|TWO_SIDED||||||Wilcoxon sign rank test|||Statistical analysis for CFB at Visit 10.||||=0.001
72626203|NCT00402987|144781742|SUPERIORITY_OR_OTHER_LEGACY|||||||0.053||95.0||||"Analysis at 7 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.053
72626204|NCT00402987|144781742|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 8 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
72626205|NCT00402987|144781742|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 8 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
72532398|NCT01362062|144593856|SUPERIORITY_OR_OTHER||||||=|0.001|TWO_SIDED||||||Wilcoxon sign rank test|||Statistical analysis for CFB at Visit 11.||||=0.001
72532399|NCT01362062|144593856|SUPERIORITY_OR_OTHER||||||=|0.001|TWO_SIDED||||||Wilcoxon sign rank test|||Statistical analysis for CFB at Visit 12.||||=0.001
72532400|NCT01362062|144593856|SUPERIORITY_OR_OTHER||||||=|0.001|TWO_SIDED||||||Wilcoxon sign rank test|||Statistical analysis for CFB at Visit 13.||||=0.001
72532401|NCT01362062|144593857|SUPERIORITY_OR_OTHER||||||=|0.001|TWO_SIDED||||||Wilcoxon sign rank test|||Statistical analysis for CFB at Visit 3.||||=0.001
72532402|NCT01362062|144593857|SUPERIORITY_OR_OTHER||||||=|0.001|TWO_SIDED||||||Wilcoxon sign rank test|||Statistical analysis for CFB at Visit 4.||||=0.001
72532403|NCT01362062|144593857|SUPERIORITY_OR_OTHER||||||=|0.001|TWO_SIDED||||||Wilcoxon sign rank test|||Statistical analysis for CFB at Visit 5.||||=0.001
72532404|NCT01362062|144593857|SUPERIORITY_OR_OTHER||||||=|0.001|TWO_SIDED||||||Wilcoxon sign rank test|||Statistical analysis for CFB at Visit 6.||||=0.001
72532405|NCT01362062|144593857|SUPERIORITY_OR_OTHER||||||=|0.001|TWO_SIDED||||||Wilcoxon sign rank test|||Statistical analysis for CFB at Visit 7.||||=0.001
72532406|NCT01362062|144593857|SUPERIORITY_OR_OTHER||||||=|0.001|TWO_SIDED||||||Wilcoxon sign rank test|||Statistical analysis for CFB at Visit 8.||||=0.001
72532407|NCT01362062|144593857|SUPERIORITY_OR_OTHER||||||=|0.001|TWO_SIDED||||||Wilcoxon sign rank test|||Statistical analysis for CFB at Visit 9.||||=0.001
72532408|NCT01362062|144593857|SUPERIORITY_OR_OTHER||||||=|0.001|TWO_SIDED||||||Wilcoxon sign rank test|||Statistical analysis for CFB at Visit 10.||||=0.001
72532409|NCT01362062|144593857|SUPERIORITY_OR_OTHER||||||=|0.001|TWO_SIDED||||||Wilcoxon sign rank test|||Statistical analysis for CFB at Visit 11.||||=0.001
72532410|NCT01362062|144593857|SUPERIORITY_OR_OTHER||||||=|0.001|TWO_SIDED||||||Wilcoxon sign rank test|||Statistical analysis for CFB at Visit 12.||||=0.001
72532411|NCT01362062|144593857|SUPERIORITY_OR_OTHER||||||=|0.001|TWO_SIDED||||||Wilcoxon sign rank test|||Statistical analysis for CFB at Visit 13.||||=0.001
72532412|NCT01362062|144593858|SUPERIORITY_OR_OTHER||||||=|0.064|TWO_SIDED||||||Wilcoxon sign rank test|||Statistical analysis for CFB at Visit 3.||||=0.064
72532413|NCT01362062|144593858|SUPERIORITY_OR_OTHER||||||=|0.104|TWO_SIDED||||||Wilcoxon sign rank test|||Statistical analysis for CFB at Visit 4.||||=0.104
72532414|NCT01362062|144593858|SUPERIORITY_OR_OTHER||||||=|0.052|TWO_SIDED||||||Wilcoxon sign rank test|||Statistical analysis for CFB at Visit 5.||||=0.052
72532415|NCT01362062|144593858|SUPERIORITY_OR_OTHER||||||=|0.043|TWO_SIDED||||||Wilcoxon sign rank test|||Statistical analysis for CFB at Visit 6.||||=0.043
72532416|NCT01362062|144593858|SUPERIORITY_OR_OTHER||||||=|0.015|TWO_SIDED||||||Wilcoxon sign rank test|||Statistical analysis for CFB of Visit 7.||||=0.015
72532417|NCT01362062|144593858|SUPERIORITY_OR_OTHER||||||=|0.023|TWO_SIDED||||||Wilcoxon sign rank test|||Statistical analysis for CFB at Visit 8.||||=0.023
72532418|NCT01362062|144593858|SUPERIORITY_OR_OTHER||||||=|0.028|TWO_SIDED||||||Wilcoxon sign rank test|||Statistical analysis for CFB at Visit 9.||||=0.028
72532419|NCT01362062|144593858|SUPERIORITY_OR_OTHER||||||=|0.048|TWO_SIDED||||||Wilcoxon sign rank test|||Statistical analysis for CFB at Visit 10.||||=0.048
72532420|NCT01362062|144593858|SUPERIORITY_OR_OTHER||||||=|0.025|TWO_SIDED||||||Wilcoxon sign rank test|||Statistical analysis for CFB at Visit 11.||||=0.025
72532421|NCT01362062|144593858|SUPERIORITY_OR_OTHER||||||=|0.023|TWO_SIDED||||||Wilcoxon sign rank test|||Statistical analysis for CFB at Visit 12.||||=0.023
72532422|NCT01362062|144593858|SUPERIORITY_OR_OTHER||||||=|0.022|TWO_SIDED||||||Wilcoxon sign rank test|||Statistical analysis for CFB at Visit 13.||||=0.022
72532423|NCT00950755|144593866|SUPERIORITY_OR_OTHER||percentage of participants|76.0|||||TWO_SIDED|95.0|62.0|89.0|||||The estimated value represents the percentage of participants with response.|||89|62|
72532424|NCT00950755|144593867|SUPERIORITY_OR_OTHER||percentage of participants|54.0|||||TWO_SIDED|95.0|38.0|69.0|||||The estimated value represents the percentage of participants with confirmed response.|||69|38|
72532425|NCT00950755|144593868|SUPERIORITY_OR_OTHER||percentage of participants|34.0|||||TWO_SIDED|95.0|20.0|49.0|||||The estimated value represents the percentage of participants with confirmed CR.|||49|20|
72532426|NCT00950755|144593869|SUPERIORITY_OR_OTHER||percentage of participants|41.0|||||TWO_SIDED|95.0|26.0|57.0|||||The estimated value represents the percentage of participants with confirmed CR + CCR.|||57|26|
72532427|NCT00950755|144593870|SUPERIORITY_OR_OTHER||percentage of participants|10.0|||||TWO_SIDED|95.0|1.0|19.0|||||The estimated value represents the percentage of participants with confirmed PR.|||19|1|
72532428|NCT02549040|144593887|OTHER||Geometric mean ratio|0.96|||||TWO_SIDED|90.0|0.85|1.09||||||Comparison of Treatment B: MK-1439 150 mg tablet (40% drug loaded granule) vs. Treatment A: MK-1439 100 mg film coated tablet||1.09|0.85|
72532429|NCT02549040|144593887|OTHER||Geometric mean ratio|1.13|||||TWO_SIDED|90.0|1.02|1.26||||||Comparison of Treatment C: MK-1439 150 mg tablet (30% drug loaded granule) vs. Treatment A: MK-1439 100 mg film coated tablet||1.26|1.02|
72532430|NCT02549040|144593887|OTHER||Geometric mean ratio|0.99|||||TWO_SIDED|90.0|0.88|1.11||||||Comparison of Treatment D: MK-1439 150 mg tablet (50% drug loaded granule) vs. Treatment A: MK-1439 100 mg film coated tablet||1.11|0.88|
72532431|NCT02549040|144593887|OTHER||Geometric mean ratio|0.89|||||TWO_SIDED|90.0|0.8|0.99||||||Comparison of Treatment E: MK-1439 100 mg tablet (30% drug loaded granule) vs. Treatment A: MK-1439 100 mg film coated tablet||0.99|0.80|
72532432|NCT02549040|144593888|OTHER||Geometric mean ratio|0.88|||||TWO_SIDED|90.0|0.79|0.98||||||Comparison of Treatment B: MK-1439 150 mg tablet (40% drug loaded granule) vs. Treatment A: MK-1439 100 mg film coated tablet||0.98|0.79|
72532433|NCT02549040|144593888|OTHER||Geometric mean ratio|1.09|||||TWO_SIDED|90.0|0.98|1.21||||||Comparison of Treatment C: MK-1439 150 mg tablet (30% drug loaded granule) vs. Treatment A: MK-1439 100 mg film coated tablet||1.21|0.98|
72532434|NCT02549040|144593888|OTHER||Geometric mean ratio|0.9|||||TWO_SIDED|90.0|0.81|1.0||||||Comparison of Treatment D: MK-1439 150 mg tablet (50% drug loaded granule) vs. Treatment A: MK-1439 100 mg film coated tablet||1.00|0.81|
72532435|NCT02549040|144593888|OTHER||Geometric mean ratio|0.88|||||TWO_SIDED|90.0|0.79|0.97||||||Comparison of Treatment E: MK-1439 100 mg tablet (30% drug loaded granule) vs. Treatment A: MK-1439 100 mg film coated tablet||0.97|0.79|
72532436|NCT02549040|144593889|OTHER||Geometric mean ratio|0.7|||||TWO_SIDED|90.0|0.61|0.82||||||Comparison of Treatment B: MK-1439 150 mg tablet (40% drug loaded granule) vs. Treatment A: MK-1439 100 mg film coated tablet||0.82|0.61|
72532437|NCT02549040|144593889|OTHER||Geometric mean ratio|0.87|||||TWO_SIDED|90.0|0.75|1.01||||||Comparison of Treatment C: MK-1439 150 mg tablet (30% drug loaded granule) vs. Treatment A: MK-1439 100 mg film coated tablet||1.01|0.75|
72532438|NCT02549040|144593889|OTHER||Geometric mean ratio|0.7|||||TWO_SIDED|90.0|0.6|0.81||||||Comparison of Treatment D: MK-1439 150 mg tablet (50% drug loaded granule) vs. Treatment A: MK-1439 100 mg film coated tablet||0.81|0.60|
72532439|NCT02549040|144593889|OTHER||Geometric mean ratio|0.76|||||TWO_SIDED|90.0|0.66|0.86||||||Comparison of Treatment E: MK-1439 100 mg tablet (30% drug loaded granule) vs. Treatment A: MK-1439 100 mg film coated tablet||0.86|0.66|
72532440|NCT02549040|144593890|OTHER||Geometric mean ratio|0.82|||||TWO_SIDED|90.0|0.72|0.93||||||Comparison of Treatment B: MK-1439 150 mg tablet (40% drug loaded granule) vs. Treatment A: MK-1439 100 mg film coated tablet||0.93|0.72|
72532441|NCT02549040|144593890|OTHER||Geometric mean ratio|1.05|||||TWO_SIDED|90.0|0.94|1.18||||||Comparison of Treatment C: MK-1439 150 mg tablet (30% drug loaded granule) vs. Treatment A: MK-1439 100 mg film coated tablet||1.18|0.94|
72532442|NCT02549040|144593890|OTHER||Geometric mean ratio|0.85|||||TWO_SIDED|90.0|0.76|0.96||||||Comparison of Treatment D: MK-1439 150 mg tablet (50% drug loaded granule) vs. Treatment A: MK-1439 100 mg film coated tablet||0.96|0.76|
72532443|NCT02549040|144593890|OTHER||Geometric mean ratio|0.83|||||TWO_SIDED|90.0|0.74|0.94||||||Comparison of Treatment E: MK-1439 100 mg tablet (30% drug loaded granule) vs. Treatment A: MK-1439 100 mg film coated tablet||0.94|0.74|
72532444|NCT02549040|144593893|OTHER||Geometric mean ratio|0.84|||||TWO_SIDED|90.0|0.75|0.94||||||Comparison of Treatment B: MK-1439 150 mg tablet (40% drug loaded granule) vs. Treatment A: MK-1439 100 mg film coated tablet||0.94|0.75|
72532445|NCT02549040|144593893|OTHER||Geometric mean ratio|1.06|||||TWO_SIDED|90.0|0.95|1.18||||||Comparison of Treatment C: MK-1439 150 mg tablet (30% drug loaded granule) vs. Treatment A: MK-1439 100 mg film coated tablet||1.18|0.95|
72532446|NCT02549040|144593893|OTHER||Geometric mean ratio|0.85|||||TWO_SIDED|90.0|0.76|0.95||||||Comparison of Treatment D: MK-1439 150 mg tablet (50% drug loaded granule) vs. Treatment A: MK-1439 100 mg film coated tablet||0.95|0.76|
72532447|NCT02549040|144593893|OTHER||Geometric mean ratio|0.86|||||TWO_SIDED|90.0|0.77|0.96||||||Comparison of Treatment E: MK-1439 100 mg tablet (30% drug loaded granule) vs. Treatment A: MK-1439 100 mg film coated tablet||0.96|0.77|
72532448|NCT00329433|144593913|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0|||||Fisher Exact|||Published data show that the incidence of PF4/heparin EIA antibodies is approximately 40% (range, 20% to 60%) following cardiac surgery. We estimated that antibody formation would occur in approximately 20% of patients following thoracic surgery. Sixty patients in each group would provide 80% power to detect a decrease in the incidence of positive PF4/heparin EIA tests from 20% to 4% at an alpha level of \<0.05.||||<0.05
72532449|NCT00329433|144593914|SUPERIORITY||||||<|0.05|||||||Fisher Exact|||||||<0.05
72532450|NCT00329433|144593915|SUPERIORITY||||||<|0.05|||||||Fisher Exact|||||||<0.05
72532451|NCT01189201|144593916|NON_INFERIORITY_OR_EQUIVALENCE|Ratio calculated as empa plus linagliptin FDC A1 (fasted) divided by empa plus linagliptin individual tablets (fasted)|Geometric Mean Ratio|104.9|STANDARD_DEVIATION|7.2|||TWO_SIDED|90.0|102.07|107.8|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment|Standard deviation is actually the geometric coefficient of variation (gCV)|No formal testing, investigation of relative bioavailability||107.80|102.07|
72626206|NCT00402987|144781742|SUPERIORITY_OR_OTHER_LEGACY|||||||0.02||95.0||||"Analysis at 8 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.020
72626207|NCT00402987|144781742|SUPERIORITY_OR_OTHER_LEGACY|||||||0.484||95.0||||"Analysis at 8 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.484
72626208|NCT00402987|144781742|SUPERIORITY_OR_OTHER_LEGACY|||||||0.197||95.0||||"Analysis at 8 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.197
72626209|NCT00402987|144781742|SUPERIORITY_OR_OTHER_LEGACY|||||||0.086||95.0||||"Analysis at 8 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.086
72626210|NCT00402987|144781742|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 9 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
72626211|NCT00402987|144781742|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 9 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
72369207|NCT00611026|144248555|SUPERIORITY_OR_OTHER|||||||0.1503|TWO_SIDED||||||Van Elteren's Test|P-value based on Van Elteren's Test (a stratified Wilcoxon-Mann Whitney test) adjusted by baseline quartile of voided volume.||Treatment difference fesoterodine vs tolterodine ER at Week 1. Treatment effects estimated by Winsorized means (5% of the tails were censored, ie, replaced with the value at the 5th and 95th percentile, respectively).||||0.1503
72532452|NCT01189201|144593917|NON_INFERIORITY_OR_EQUIVALENCE|Ratio calculated as empa plus linagliptin FDC A1 (fasted) divided by empa plus linagliptin individual tablets (fasted)|Geometric Mean Ratio|104.91|STANDARD_DEVIATION|12.8|||TWO_SIDED|90.0|99.97|110.09|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment|Standard deviation is actually the gCV|No formal testing, investigation of relative bioavailability||110.09|99.97|
72532453|NCT01189201|144593918|NON_INFERIORITY_OR_EQUIVALENCE|Ratio calculated as empa plus linagliptin FDC A1 (fasted) divided by empa plus linagliptin individual tablets (fasted)|Geometric Mean Ratio|107.68|STANDARD_DEVIATION|15.3|||TWO_SIDED|90.0|101.7|114.02|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment|Standard deviation is actually the gCV|No formal testing, investigation of relative bioavailability||114.02|101.70|
72532454|NCT01189201|144593919|NON_INFERIORITY_OR_EQUIVALENCE|Ratio calculated as empa plus linagliptin FDC A1 (fasted) divided by empa plus linagliptin individual tablets (fasted)|Geometric Mean Ratio|109.68|STANDARD_DEVIATION|26.2|||TWO_SIDED|90.0|99.55|120.83|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment|Standard deviation is actually the gCV|No formal testing, investigation of relative bioavailability||120.83|99.55|
72532455|NCT01189201|144593922|NON_INFERIORITY_OR_EQUIVALENCE|Ratio calculated as empa plus linagliptin FDC A1 (fasted) divided by empa plus linagliptin individual tablets (fasted)|Geometric Mean Ratio|104.78|STANDARD_DEVIATION|7.1|||TWO_SIDED|90.0|102.02|107.61|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment|Standard deviation is actually the gCV|No formal testing, investigation of relative bioavailability||107.61|102.02|
72532456|NCT01189201|144593923|NON_INFERIORITY_OR_EQUIVALENCE|Ratio calculated as empa plus linagliptin FDC A1 (fasted) divided by empa plus linagliptin individual tablets (fasted)|Geometric Mean Ratio|104.64|STANDARD_DEVIATION|19.7|||TWO_SIDED|90.0|97.23|112.62|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment|Standard deviation is actually the gCV|No formal testing, investigation of relative bioavailability||112.62|97.23|
72532457|NCT01189201|144593924|NON_INFERIORITY_OR_EQUIVALENCE|Ratio calculated as empa plus linagliptin FDC A1 (fasted) divided by empa plus linagliptin FDC A1 (fed)|Geometric Mean Ratio|85.86|STANDARD_DEVIATION|9.3|||TWO_SIDED|90.0|81.33|90.64|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment|Standard deviation is actually the gCV|No formal testing, investigation of relative bioavailability||90.64|81.33|
72626212|NCT00402987|144781742|SUPERIORITY_OR_OTHER_LEGACY|||||||0.018||95.0||||"Analysis at 9 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.018
72626213|NCT00402987|144781742|SUPERIORITY_OR_OTHER_LEGACY|||||||0.561||95.0||||"Analysis at 9 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.561
72626214|NCT00402987|144781742|SUPERIORITY_OR_OTHER_LEGACY|||||||0.252||95.0||||"Analysis at 9 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.252
72626215|NCT00402987|144781742|SUPERIORITY_OR_OTHER_LEGACY|||||||0.136||95.0||||"Analysis at 9 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.136
72626216|NCT00402987|144781742|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 10 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
72626217|NCT00402987|144781742|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 10 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
72626218|NCT00402987|144781742|SUPERIORITY_OR_OTHER_LEGACY|||||||0.018||95.0||||"Analysis at 10 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.018
72626219|NCT00402987|144781742|SUPERIORITY_OR_OTHER_LEGACY|||||||0.653||95.0||||"Analysis at 10 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.653
72532458|NCT01189201|144593925|NON_INFERIORITY_OR_EQUIVALENCE|Ratio calculated as empa plus linagliptin FDC A1 (fasted) divided by empa plus linagliptin FDC A1 (fed)|Geometric Mean Ratio|61.41|STANDARD_DEVIATION|22.0|||TWO_SIDED|90.0|54.1|69.71|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment|Standard deviation is actually the gCV|No formal testing, investigation of relative bioavailability||69.71|54.10|
72532459|NCT01189201|144593926|NON_INFERIORITY_OR_EQUIVALENCE|Ratio calculated as empa plus linagliptin FDC A1 (fasted) divided by empa plus linagliptin FDC A1 (fed)|Geometric Mean Ratio|85.32|STANDARD_DEVIATION|9.4|||TWO_SIDED|90.0|80.77|90.14|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment|Standard deviation is actually the gCV|No formal testing, investigation of relative bioavailability||90.14|80.77|
72532460|NCT01189201|144593927|NON_INFERIORITY_OR_EQUIVALENCE|Ratio calculated as empa plus linagliptin FDC A1 (fasted) divided by empa plus linagliptin FDC A1 (fed)|Geometric Mean Ratio|93.18|STANDARD_DEVIATION|15.7|||TWO_SIDED|90.0|85.07|102.05|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment|Standard deviation is actually the gCV|No formal testing, investigation of relative bioavailability||102.05|85.07|
72532461|NCT01189201|144593928|NON_INFERIORITY_OR_EQUIVALENCE|Ratio calculated as empa plus linagliptin FDC A1 (fasted) divided by empa plus linagliptin FDC A1 (fed)|Geometric Mean Ratio|68.48|STANDARD_DEVIATION|27.2|||TWO_SIDED|90.0|58.59|80.03|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment|Standard deviation is actually the gCV|No formal testing, investigation of relative bioavailability||80.03|58.59|
72532462|NCT01189201|144593929|NON_INFERIORITY_OR_EQUIVALENCE|Ratio calculated as empa plus linagliptin FDC A1 (fasted) divided by empa plus linagliptin FDC A1 (fed)|Geometric Mean Ratio|90.95|STANDARD_DEVIATION|13.2|||TWO_SIDED|90.0|84.24|98.19|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment|Standard deviation is actually the gCV|No formal testing, investigation of relative bioavailability||98.19|84.24|
72532463|NCT01189201|144593930|NON_INFERIORITY_OR_EQUIVALENCE|Ratio calculated as empa plus linagliptin FDC A1 (fasted) divided by empa plus linagliptin FDC A3 (fasted)|Geometric Mean Ratio|95.64|STANDARD_DEVIATION|9.6|||TWO_SIDED|90.0|91.19|100.3|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment|Standard deviation is actually the gCV|No formal testing, investigation of relative bioavailability||100.30|91.19|
72532464|NCT01189201|144593931|NON_INFERIORITY_OR_EQUIVALENCE|Ratio calculated as empa plus linagliptin FDC A1 (fasted) divided by empa plus linagliptin FDC A3 (fasted)|Geometric Mean Ratio|98.04|STANDARD_DEVIATION|13.0|||TWO_SIDED|90.0|91.95|104.53|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment|Standard deviation is actually the gCV|No formal testing, investigation of relative bioavailability||104.53|91.95|
72532465|NCT01189201|144593932|NON_INFERIORITY_OR_EQUIVALENCE|Ratio calculated as empa plus linagliptin FDC A1 (fasted) divided by empa plus linagliptin FDC A3 (fasted)|Geometric Mean Ratio|95.69|STANDARD_DEVIATION|9.8|||TWO_SIDED|90.0|91.17|100.43|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment|Standard deviation is actually the gCV|No formal testing, investigation of relative bioavailability||100.43|91.17|
72532466|NCT01189201|144593933|NON_INFERIORITY_OR_EQUIVALENCE|Ratio calculated as empa plus linagliptin FDC A1 (fasted) divided by empa plus linagliptin FDC A3 (fasted)|Geometric Mean Ratio|92.98|STANDARD_DEVIATION|14.9|||TWO_SIDED|90.0|86.36|100.09|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment|Standard deviation is actually the gCV|No formal testing, investigation of relative bioavailability||100.09|86.36|
72532467|NCT01189201|144593934|NON_INFERIORITY_OR_EQUIVALENCE|Ratio calculated as empa plus linagliptin FDC A1 (fasted) divided by empa plus linagliptin FDC A3 (fasted)|Geometric Mean Ratio|103.71|STANDARD_DEVIATION|22.4|||TWO_SIDED|90.0|92.93|115.74|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment|Standard deviation is actually the gCV|No formal testing, investigation of relative bioavailability||115.74|92.93|
72532468|NCT01189201|144593935|NON_INFERIORITY_OR_EQUIVALENCE|Ratio calculated as empa plus linagliptin FDC A1 (fasted) divided by empa plus linagliptin FDC A3 (fasted)|Geometric Mean Ratio|96.36|STANDARD_DEVIATION|14.3|||TWO_SIDED|90.0|89.78|103.42|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment|Standard deviation is actually the gCV|No formal testing, investigation of relative bioavailability||103.42|89.78|
72532469|NCT04308668|144593943|SUPERIORITY||Mean Difference (Net)|-2.4||||0.35|TWO_SIDED|95.0|-7.0|2.2|||Fisher Exact||Values represent percentages. Experimental treatment arm compared with the placebo control arm.|||2.2|-7.0|0.35
72532470|NCT04308668|144593944|SUPERIORITY||Mean Difference (Net)|-0.27||||0.117|TWO_SIDED|95.0|-0.61|0.27|||Mixed Models Analysis|||||0.27|-0.61|0.117
72532471|NCT03808298|144593959|OTHER|Placebo-corrected change-from-baseline QTcF (ms) at Day 14 0.75 Hours Pre-dose|LS Mean|0.5|STANDARD_ERROR_OF_MEAN|1.47|||TWO_SIDED|90.0|-1.99|2.9||||||||2.90|-1.99|
72532472|NCT03808298|144593959|OTHER|Placebo-corrected change-from-baseline QTcF (ms) at Day 14 0.5 Hours Pre-dose|LS Mean|-0.2|STANDARD_ERROR_OF_MEAN|1.5|||TWO_SIDED|90.0|-2.73|2.24||||||||2.24|-2.73|
72532473|NCT03808298|144593959|OTHER|Placebo-corrected change-from-baseline QTcF (ms) at Day 14 0.25 Hours Pre-dose|LS Mean|0.3|STANDARD_ERROR_OF_MEAN|1.52|||TWO_SIDED|90.0|-2.25|2.79||||||||2.79|-2.25|
72532474|NCT03808298|144593959|OTHER|Placebo-corrected change-from-baseline QTcF (ms) at Day 14 0.5 Hours Post-dose|LS Mean|0.6|STANDARD_ERROR_OF_MEAN|1.52|||TWO_SIDED|90.0|-1.94|3.09||||||||3.09|-1.94|
72532475|NCT03808298|144593959|OTHER|Placebo-corrected change-from-baseline QTcF (ms) at Day 14 1 Hours Post-dose|LS Mean|-0.1|STANDARD_ERROR_OF_MEAN|1.5|||TWO_SIDED|90.0|-2.62|2.35||||||||2.35|-2.62|
72532476|NCT03808298|144593959|OTHER|Placebo-corrected change-from-baseline QTcF (ms) at Day 14 2.5 Hours Post-dose|LS Mean|1.6|STANDARD_ERROR_OF_MEAN|1.51|||TWO_SIDED|90.0|-0.88|4.11||||||||4.11|-0.88|
72532477|NCT03808298|144593959|OTHER|Placebo-corrected change-from-baseline QTcF (ms) at Day 14 4 Hours Post-dose|LS Mean|1.1|STANDARD_ERROR_OF_MEAN|1.66|||TWO_SIDED|90.0|-1.63|3.85||||||||3.85|-1.63|
72532478|NCT03808298|144593959|OTHER|Placebo-corrected change-from-baseline QTcF (ms) at Day 14 8 Hours Post-dose|LS Mean|-0.2|STANDARD_ERROR_OF_MEAN|1.79|||TWO_SIDED|90.0|-3.13|2.79||||||||2.79|-3.13|
72532479|NCT03808298|144593959|OTHER|Placebo-corrected change-from-baseline QTcF (ms) at Day 14 12 Hours Post-dose|LS Mean|0.9|STANDARD_ERROR_OF_MEAN|2.13|||TWO_SIDED|90.0|-2.6|4.47||||||||4.47|-2.60|
72532480|NCT03808298|144593959|OTHER|Placebo-corrected change-from-baseline QTcF (ms) at Day 14 24 Hours Post-dose|LS Mean|0.5|STANDARD_ERROR_OF_MEAN|1.52|||TWO_SIDED|90.0|-2.03|2.98||||||||2.98|-2.03|
72369208|NCT00611026|144248555|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Van Elteren's Test|P-value based on Van Elteren's Test (a stratified Wilcoxon-Mann Whitney test) adjusted by baseline quartile of voided volume.||Treatment difference fesoterodine vs placebo at Week 4. Treatment effects estimated by Winsorized means (5% of the tails were censored, ie, replaced with the value at the 5th and 95th percentile, respectively).||||<0.0001
72532481|NCT03808298|144593960|OTHER|Placebo-corrected change-from-baseline QTcF (ms) at Day 1 0.5 Hours Post-dose|LS Mean|1.2|STANDARD_ERROR_OF_MEAN|0.86|||TWO_SIDED|90.0|-0.19|2.64||||||||2.64|-0.19|
72532482|NCT03808298|144593960|OTHER|Placebo-corrected change-from-baseline QTcF (ms) at Day 1 1 Hours Post-dose|LS Mean|1.1|STANDARD_ERROR_OF_MEAN|0.74|||TWO_SIDED|90.0|-0.12|2.33||||||||2.33|-0.12|
72532483|NCT03808298|144593960|OTHER|Placebo-corrected change-from-baseline QTcF (ms) at Day 1 2.5 Hours Post-dose|LS Mean|2.0|STANDARD_ERROR_OF_MEAN|0.99|||TWO_SIDED|90.0|0.4|3.67||||||||3.67|0.40|
72532484|NCT03808298|144593960|OTHER|Placebo-corrected change-from-baseline QTcF (ms) at Day 1 4 Hours Post-dose|LS Mean|2.5|STANDARD_ERROR_OF_MEAN|1.18|||TWO_SIDED|90.0|0.6|4.49||||||||4.49|0.60|
72532485|NCT03808298|144593960|OTHER|Placebo-corrected change-from-baseline QTcF (ms) at Day 1 8 Hours Post-dose|LS Mean|2.5|STANDARD_ERROR_OF_MEAN|1.46|||TWO_SIDED|90.0|0.09|4.94||||||||4.94|0.09|
72532486|NCT03808298|144593960|OTHER|Placebo-corrected change-from-baseline QTcF (ms) at Day 1 12 Hours Post-dose|LS Mean|1.4|STANDARD_ERROR_OF_MEAN|1.84|||TWO_SIDED|90.0|-1.62|4.47||||||||4.47|-1.62|
72532487|NCT03808298|144593960|OTHER|Placebo-corrected change-from-baseline QTcF (ms) at Day 1 24 Hours Post-dose|LS Mean|1.6|STANDARD_ERROR_OF_MEAN|1.05|||TWO_SIDED|90.0|-0.1|3.39||||||||3.39|-0.10|
72532488|NCT03808298|144593961|OTHER|Placebo-corrected change-from-baseline QTcF (ms) at Day 1 0.5 Hours Post-dose|LS Mean|0.8|STANDARD_ERROR_OF_MEAN|0.85|||TWO_SIDED|90.0|-0.6|2.2||||||||2.20|-0.60|
72532489|NCT03808298|144593961|OTHER|Placebo-corrected change-from-baseline QTcF (ms) at Day 1 1 Hours Post-dose|LS Mean|1.3|STANDARD_ERROR_OF_MEAN|0.73|||TWO_SIDED|90.0|0.13|2.55||||||||2.55|0.13|
72532490|NCT03808298|144593961|OTHER|Placebo-corrected change-from-baseline QTcF (ms) at Day 1 2.5 Hours Post-dose|LS Mean|1.7|STANDARD_ERROR_OF_MEAN|0.98|||TWO_SIDED|90.0|0.04|3.27||||||||3.27|0.04|
72532491|NCT03808298|144593961|OTHER|Placebo-corrected change-from-baseline QTcF (ms) at Day 1 4 Hours Post-dose|LS Mean|1.3|STANDARD_ERROR_OF_MEAN|1.16|||TWO_SIDED|90.0|-0.64|3.2||||||||3.20|-0.64|
72532492|NCT03808298|144593961|OTHER|Placebo-corrected change-from-baseline QTcF (ms) at Day 1 8 Hours Post-dose|LS Mean|2.3|STANDARD_ERROR_OF_MEAN|1.45|||TWO_SIDED|90.0|-0.13|4.67||||||||4.67|-0.13|
72532493|NCT03808298|144593961|OTHER|Placebo-corrected change-from-baseline QTcF (ms) at Day 1 12 Hours Post-dose|LS Mean|0.7|STANDARD_ERROR_OF_MEAN|1.82|||TWO_SIDED|90.0|-2.31|3.7||||||||3.70|-2.31|
72532494|NCT03808298|144593961|OTHER|Placebo-corrected change-from-baseline QTcF (ms) at Day 1 24 Hours Post-dose|LS Mean|0.4|STANDARD_ERROR_OF_MEAN|1.04|||TWO_SIDED|90.0|-1.35|2.1||||||||2.10|-1.35|
72532495|NCT03808298|144593961|OTHER|Placebo-corrected change-from-baseline QTcF (ms) at Day 14 0.75 Hours Pre-dose|LS Mean|-0.5|STANDARD_ERROR_OF_MEAN|1.46|||TWO_SIDED|90.0|-2.94|1.89||||||||1.89|-2.94|
72532496|NCT03808298|144593961|OTHER|Placebo-corrected change-from-baseline QTcF (ms) at Day 14 0.5 Hours Pre-dose|LS Mean|-0.7|STANDARD_ERROR_OF_MEAN|1.48|||TWO_SIDED|90.0|-3.19|1.72||||||||1.72|-3.19|
72532497|NCT03808298|144593961|OTHER|Placebo-corrected change-from-baseline QTcF (ms) at Day 14 0.25 Hours Pre-dose|LS Mean|0.2|STANDARD_ERROR_OF_MEAN|1.51|||TWO_SIDED|90.0|-2.26|2.74||||||||2.74|-2.26|
72532498|NCT03808298|144593961|OTHER|Placebo-corrected change-from-baseline QTcF (ms) at Day 14 0.5 Hours Post-dose|LS Mean|0.5|STANDARD_ERROR_OF_MEAN|1.51|||TWO_SIDED|90.0|-2.02|2.96||||||||2.96|-2.02|
72532499|NCT03808298|144593961|EQUIVALENCE|Placebo-corrected change-from-baseline QTcF (ms) at Day 14 1 Hours Post-dose|LS Mean|0.1|STANDARD_ERROR_OF_MEAN|1.49|||TWO_SIDED|90.0|-2.39|2.54||||||||2.54|-2.39|
72532500|NCT03808298|144593961|OTHER|Placebo-corrected change-from-baseline QTcF (ms) at Day 14 2.5 Hours Post-dose|LS Mean|1.8|STANDARD_ERROR_OF_MEAN|1.5|||TWO_SIDED|90.0|-0.67|4.28||||||||4.28|-0.67|
72532501|NCT03808298|144593961|OTHER|Placebo-corrected change-from-baseline QTcF (ms) at Day 14 4 Hours Post-dose|LS Mean|0.6|STANDARD_ERROR_OF_MEAN|1.64|||TWO_SIDED|90.0|-2.11|3.31||||||||3.31|-2.11|
72532502|NCT03808298|144593961|OTHER|Placebo-corrected change-from-baseline QTcF (ms) at Day 14 8 Hours Post-dose|LS Mean|0.5|STANDARD_ERROR_OF_MEAN|1.76|||TWO_SIDED|90.0|-2.38|3.47||||||||3.47|-2.38|
72532503|NCT03808298|144593961|OTHER|Placebo-corrected change-from-baseline QTcF (ms) at Day 14 12 Hours Post-dose|LS Mean|0.6|STANDARD_ERROR_OF_MEAN|2.11|||TWO_SIDED|90.0|-2.85|4.14||||||||4.14|-2.85|
72532504|NCT03808298|144593961|OTHER|Placebo-corrected change-from-baseline QTcF (ms) at Day 14 24 Hours Post-dose|LS Mean|0.1|STANDARD_ERROR_OF_MEAN|1.5|||TWO_SIDED|90.0|-2.36|2.6||||||||2.60|-2.36|
72532505|NCT03808298|144593962|OTHER|Placebo-corrected change-from-baseline HR (bpm) at Day 1 0.5 Hours Post-dose|LS Mean|-0.2|STANDARD_ERROR_OF_MEAN|0.59|||TWO_SIDED|90.0|-1.2|0.73||||||||0.73|-1.20|
72532506|NCT03808298|144593962|OTHER|Placebo-corrected change-from-baseline HR (bpm) at Day 1 1 Hours Post-dose|LS Mean|-0.1|STANDARD_ERROR_OF_MEAN|0.62|||TWO_SIDED|90.0|-1.08|0.96||||||||0.96|-1.08|
72532507|NCT03808298|144593962|OTHER|Placebo-corrected change-from-baseline HR (bpm) at Day 1 2.5 Hours Post-dose|LS Mean|-0.5|STANDARD_ERROR_OF_MEAN|0.76|||TWO_SIDED|90.0|-1.73|0.78||||||||0.78|-1.73|
72532508|NCT03808298|144593962|OTHER|Placebo-corrected change-from-baseline HR (bpm) at Day 1 4 Hours Post-dose|LS Mean|-0.6|STANDARD_ERROR_OF_MEAN|0.75|||TWO_SIDED|90.0|-1.8|0.7||||||||0.70|-1.80|
72532509|NCT03808298|144593962|OTHER|Placebo-corrected change-from-baseline HR (bpm) at Day 1 8 Hours Post-dose|LS Mean|-0.7|STANDARD_ERROR_OF_MEAN|1.05|||TWO_SIDED|90.0|-2.42|1.05||||||||1.05|-2.42|
72532510|NCT03808298|144593962|OTHER|Placebo-corrected change-from-baseline HR (bpm) at Day 1 12 Hours Post-dose|LS Mean|-0.7|STANDARD_ERROR_OF_MEAN|1.18|||TWO_SIDED|90.0|-2.66|1.24||||||||1.24|-2.66|
72626220|NCT00402987|144781742|SUPERIORITY_OR_OTHER_LEGACY|||||||0.287||95.0||||"Analysis at 10 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.287
72626221|NCT00402987|144781742|SUPERIORITY_OR_OTHER_LEGACY|||||||0.191||95.0||||"Analysis at 10 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.191
72369209|NCT00611026|144248555|SUPERIORITY_OR_OTHER|||||||0.0002|TWO_SIDED||||||Van Elteren's Test|P-value based on Van Elteren's Test (a stratified Wilcoxon-Mann Whitney test) adjusted by baseline quartile of voided volume.||Treatment difference tolterodine ER vs placebo at Week 4. Treatment effects estimated by Winsorized means (5% of the tails were censored, ie, replaced with the value at the 5th and 95th percentile, respectively).||||0.0002
72532511|NCT03808298|144593962|OTHER|Placebo-corrected change-from-baseline HR (bpm) at Day 1 24 Hours Post-dose|LS Mean|-0.5|STANDARD_ERROR_OF_MEAN|0.83|||TWO_SIDED|90.0|-1.91|0.85||||||||0.85|-1.91|
72532512|NCT03808298|144593962|OTHER|Placebo-corrected change-from-baseline HR (bpm) at Day 14 0.75 Hours Pre-dose|LS Mean|-2.2|STANDARD_ERROR_OF_MEAN|1.03|||TWO_SIDED|90.0|-3.9|-0.48||||||||-0.48|-3.90|
72532513|NCT03808298|144593962|OTHER|Placebo-corrected change-from-baseline HR (bpm) at Day 14 0.5 Hours Pre-dose|LS Mean|-1.7|STANDARD_ERROR_OF_MEAN|1.03|||TWO_SIDED|90.0|-3.41|0.0||||||||0.00|-3.41|
72532514|NCT03808298|144593962|OTHER|Placebo-corrected change-from-baseline HR (bpm) at Day 14 0.25 Hours Pre-dose|LS Mean|-1.4|STANDARD_ERROR_OF_MEAN|1.08|||TWO_SIDED|90.0|-3.21|0.36||||||||0.36|-3.21|
72532515|NCT03808298|144593962|OTHER|Placebo-corrected change-from-baseline HR (bpm) at Day 14 0.5 Hours Pre-dose|LS Mean|-1.6|STANDARD_ERROR_OF_MEAN|0.98|||TWO_SIDED|90.0|-3.25|0.01||||||||0.01|-3.25|
72532516|NCT03808298|144593962|OTHER|Placebo-corrected change-from-baseline HR (bpm) at Day 14 1 Hours Post-dose|LS Mean|-1.7|STANDARD_ERROR_OF_MEAN|1.01|||TWO_SIDED|90.0|-3.36|-0.01||||||||-0.01|-3.36|
72532517|NCT03808298|144593962|OTHER|Placebo-corrected change-from-baseline HR (bpm) at Day 14 2.5 Hours Post-dose|LS Mean|-1.9|STANDARD_ERROR_OF_MEAN|1.09|||TWO_SIDED|90.0|-3.75|-0.14||||||||-0.14|-3.75|
72532518|NCT03808298|144593962|OTHER|Placebo-corrected change-from-baseline HR (bpm) at Day 14 4 Hours Post-dose|LS Mean|-1.4|STANDARD_ERROR_OF_MEAN|1.01|||TWO_SIDED|90.0|-3.06|0.29||||||||0.29|-3.06|
72532519|NCT03808298|144593962|OTHER|Placebo-corrected change-from-baseline HR (bpm) at Day 14 8 Hours Post-dose|LS Mean|-1.0|STANDARD_ERROR_OF_MEAN|1.24|||TWO_SIDED|90.0|-3.08|1.01||||||||1.01|-3.08|
72532520|NCT03808298|144593962|OTHER|Placebo-corrected change-from-baseline HR (bpm) at Day 14 12 Hours Post-dose|LS Mean|-1.1|STANDARD_ERROR_OF_MEAN|1.14|||TWO_SIDED|90.0|-3.03|0.76||||||||0.76|-3.03|
72532521|NCT03808298|144593962|OTHER|Placebo-corrected change-from-baseline HR (bpm) at Day 14 24 Hours Post-dose|LS Mean|-1.0|STANDARD_ERROR_OF_MEAN|1.13|||TWO_SIDED|90.0|-2.87|0.87||||||||0.87|-2.87|
72532522|NCT03808298|144593962|OTHER|Placebo-corrected change-from-baseline HR (bpm) at Day 1 0.5 Hours Post-dose|LS Mean|0.1|STANDARD_ERROR_OF_MEAN|0.59|||TWO_SIDED|90.0|-0.89|1.07||||||||1.07|-0.89|
72532523|NCT03808298|144593962|OTHER|Placebo-corrected change-from-baseline HR (bpm) at Day 1 1 Hours Post-dose|LS Mean|-0.2|STANDARD_ERROR_OF_MEAN|0.62|||TWO_SIDED|90.0|-1.21|0.86||||||||0.86|-1.21|
72532524|NCT03808298|144593962|OTHER|Placebo-corrected change-from-baseline HR (bpm) at Day 1 2.5 Hours Post-dose|LS Mean|-0.4|STANDARD_ERROR_OF_MEAN|0.77|||TWO_SIDED|90.0|-1.71|0.83||||||||0.83|-1.71|
72532525|NCT03808298|144593962|OTHER|Placebo-corrected change-from-baseline HR (bpm) at Day 1 4 Hours Post-dose|LS Mean|0.2|STANDARD_ERROR_OF_MEAN|0.76|||TWO_SIDED|90.0|-1.07|1.46||||||||1.46|-1.07|
72532526|NCT03808298|144593962|OTHER|Placebo-corrected change-from-baseline HR (bpm) at Day 1 8 Hours Post-dose|LS Mean|-0.8|STANDARD_ERROR_OF_MEAN|1.06|||TWO_SIDED|90.0|-2.5|1.0||||||||1.00|-2.50|
72532527|NCT03808298|144593962|OTHER|Placebo-corrected change-from-baseline HR (bpm) at Day 1 12 Hours Post-dose|LS Mean|-0.2|STANDARD_ERROR_OF_MEAN|1.19|||TWO_SIDED|90.0|-2.22|1.74||||||||1.74|-2.22|
72532528|NCT03808298|144593962|OTHER|Placebo-corrected change-from-baseline HR (bpm) at Day 1 24 Hours Post-dose|LS Mean|-2.2|STANDARD_ERROR_OF_MEAN|0.84|||TWO_SIDED|90.0|-3.63|-0.85||||||||-0.85|-3.63|
72532529|NCT03808298|144593962|OTHER|Placebo-corrected change-from-baseline HR (bpm) at Day 14 0.75 Hours Pre-dose|LS Mean|-0.7|STANDARD_ERROR_OF_MEAN|1.04|||TWO_SIDED|90.0|-2.42|1.03||||||||1.03|-2.42|
72532530|NCT03808298|144593962|OTHER|Placebo-corrected change-from-baseline Day 14 HR (bpm) at 0.5 Hours Pre-dose|LS Mean|-1.2|STANDARD_ERROR_OF_MEAN|1.04|||TWO_SIDED|90.0|-2.96|0.49||||||||0.49|-2.96|
72532531|NCT03808298|144593962|OTHER|Placebo-corrected change-from-baseline HR (bpm) at Day 14 0.25 Hours Pre-dose|LS Mean|-0.8|STANDARD_ERROR_OF_MEAN|1.09|||TWO_SIDED|90.0|-2.58|1.02||||||||1.02|-2.58|
72532532|NCT03808298|144593962|OTHER|Placebo-corrected change-from-baseline HR (bpm) at Day 14 0.5 Hours Post-dose|LS Mean|-0.7|STANDARD_ERROR_OF_MEAN|0.99|||TWO_SIDED|90.0|-2.34|0.95||||||||0.95|-2.34|
72532533|NCT03808298|144593962|OTHER|Placebo-corrected change-from-baseline HR (bpm) at Day 14 1 Hours Post-dose|LS Mean|-1.0|STANDARD_ERROR_OF_MEAN|1.02|||TWO_SIDED|90.0|-2.65|0.73||||||||0.73|-2.65|
72532534|NCT03808298|144593962|OTHER|Placebo-corrected change-from-baseline HR (bpm) at Day 14 2.5 Hours Post-dose|LS Mean|-1.3|STANDARD_ERROR_OF_MEAN|1.1|||TWO_SIDED|90.0|-3.11|0.53||||||||0.53|-3.11|
72532535|NCT03808298|144593962|OTHER|Placebo-corrected change-from-baseline HR (bpm) at Day 14 4 Hours Post-dose|LS Mean|-1.0|STANDARD_ERROR_OF_MEAN|1.02|||TWO_SIDED|90.0|-2.73|0.66||||||||0.66|-2.73|
72532536|NCT03808298|144593962|OTHER|Placebo-corrected change-from-baseline HR (bpm) at Day 14 8 Hours Post-dose|LS Mean|-0.7|STANDARD_ERROR_OF_MEAN|1.25|||TWO_SIDED|90.0|-2.77|1.37||||||||1.37|-2.77|
72532537|NCT03808298|144593962|OTHER|Placebo-corrected change-from-baseline HR (bpm) at Day 14 12 Hours Post-dose|LS Mean|-0.6|STANDARD_ERROR_OF_MEAN|1.15|||TWO_SIDED|90.0|-2.5|1.33||||||||1.33|-2.50|
72532538|NCT03808298|144593962|OTHER|Placebo-corrected change-from-baseline HR (bpm) at Day 14 24 Hours Post-dose|LS Mean|-1.7|STANDARD_ERROR_OF_MEAN|1.14|||TWO_SIDED|90.0|-3.57|0.2||||||||0.20|-3.57|
72626222|NCT00402987|144781742|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 11 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
72626223|NCT00402987|144781742|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 11 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
72572345|NCT04732221|144671954|SUPERIORITY||Treatment difference|-9.2||||0.068|TWO_SIDED|95.0|-21.3|2.9||A 1-sided p-value was obtained from fitting a Robust regression estimate based on a Huber-type M estimator including terms for treatment and WHO-FC (Class II and Class III/IV) at baseline|Robust Regression|Missing data at week 12 due to death were imputed using the worst observed value and other missingness were imputed using J2R method|Least Square Mean of the overall treatment difference with 95% confidence interval (CI) was reported|||2.9|-21.3|0.068
72532539|NCT03808298|144593963|OTHER|Placebo-corrected change-from-baseline PR (ms) at Day 1 0.5 Hours Post-dose|LS Mean|-1.2|STANDARD_ERROR_OF_MEAN|0.83|||TWO_SIDED|90.0|-2.56|0.17||||||||0.17|-2.56|
72572346|NCT04732221|144671954|SUPERIORITY||Treatment difference|-22.0|||<|0.001|TWO_SIDED|95.0|-33.7|-10.3||based on a Huber-type M estimator including terms for treatment and WHO-FC (Class II and Class III/IV) at baseline|Robust Regression|Missing data at week 12 due to death were imputed using the worst observed value and other missingness were imputed using J2R method|Least Square Mean of the overall treatment difference with 95% confidence interval (CI) was reported|||-10.3|-33.7|<0.001
72572347|NCT04732221|144671954|SUPERIORITY||Treatment difference|-19.9||||0.002|TWO_SIDED|95.0|-33.4|-6.4||A 1-sided p-value was obtained from fitting a Robust regression estimate based on a Huber-type M estimator including terms for treatment and WHO-FC (Class II and Class III/IV) at baseline|Robust Regression|Missing data at week 12 due to death were imputed using the worst observed value and other missingness were imputed using J2R method|Least Square Mean of the overall treatment difference with 95% confidence interval (CI) was reported|||-6.4|-33.4|0.002
72572348|NCT02906930|144671987|SUPERIORITY|This hypothesis was controlled for multiplicity. Results are based on the data from the in-trial observation period. The estimated treatment effect includes the effect of any additional anti-diabetic medication for all randomised subjects regardless of premature trial product discontinuation (treatment policy estimand).|Mean treatment difference|-1.1|||<|0.0001|TWO_SIDED|95.0|-1.3|-0.9||Unadjusted two-sided p-value for test of no difference from 0.|Pattern mixed model||Oral Semaglutide 14 mg - Placebo|The analysis was based on a pattern mixture model using multiple imputation to impute missing data for week 26, assuming that the missing data mechanism was missing at random within the groups used for the imputation. The imputed data sets were analysed using an analysis of covariance (ANCOVA) model with treatment and region as categorical fixed effects and baseline HbA1c value as covariate for each of the 1000 imputed complete data sets, and pooled by Rubin's rule to draw inference.||-0.9|-1.3|<0.0001
72572349|NCT02906930|144671987|SUPERIORITY|This hypothesis was controlled for multiplicity. Results are based on the data from the in-trial observation period. The estimated treatment effect includes the effect of any additional anti-diabetic medication for all randomised subjects regardless of premature trial product discontinuation (treatment policy estimand).|Mean treatment difference|-0.9|||<|0.0001|TWO_SIDED|95.0|-1.1|-0.6||Unadjusted two-sided p-value for test of no difference from 0.|Pattern mixed model||Oral Semaglutide 7 mg - Placebo|The analysis was based on a pattern mixture model using multiple imputation to impute missing data for week 26, assuming that the missing data mechanism was missing at random within the groups used for the imputation. The imputed data sets were analysed using an ANCOVA model with treatment and region as categorical fixed effects and baseline HbA1c value as covariate for each of the 1000 imputed complete data sets, and pooled by Rubin's rule to draw inference.||-0.6|-1.1|<0.0001
72572350|NCT02906930|144671987|SUPERIORITY|This hypothesis was controlled for multiplicity. Results are based on the data from the in-trial observation period. The estimated treatment effect includes the effect of any additional anti-diabetic medication for all randomised subjects regardless of premature trial product discontinuation (treatment policy estimand).|Mean treatment difference|-0.6|||<|0.0001|TWO_SIDED|95.0|-0.8|-0.4||Unadjusted two-sided p-value for test of no difference from 0.|Pattern mixed model||Oral Semaglutide 3 mg - Placebo|The analysis was based on a pattern mixture model using multiple imputation to impute missing data for week 26, assuming that the missing data mechanism was missing at random within the groups used for the imputation. The imputed data sets were analysed using an ANCOVA model with treatment and region as categorical fixed effects and baseline HbA1c value as covariate for each of the 1000 imputed complete data sets, and pooled by Rubin's rule to draw inference.||-0.4|-0.8|<0.0001
72572351|NCT02906930|144671987|SUPERIORITY|This hypothesis was not controlled for multiplicity. Results are based on the data from the on-treatment without rescue medication observation period. The estimated treatment effect excludes the effect of any rescue medication (hypothetical estimand).|Mean treatment difference|-0.7|||<|0.0001|TWO_SIDED|95.0|-0.9|-0.5||Unadjusted two-sided p-value for test of no difference from 0.|MMRM||Oral Semaglutide 3 mg - placebo|The analysis was based on a mixed model for repeated measurements (MMRM) that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 26. The independent effects were treatment and region as categorical fixed effects and the baseline HbA1c value as a covariate, all nested within visit, and an unstructured residual covariance matrix.||-0.5|-0.9|<0.0001
72572352|NCT02906930|144671987|SUPERIORITY|This hypothesis was not controlled for multiplicity. Results are based on the data from the on-treatment without rescue medication observation period. The estimated treatment effect excludes the effect of any rescue medication (hypothetical estimand).|Mean treatment difference|-1.2|||<|0.0001|TWO_SIDED|95.0|-1.5|-1.0||Unadjusted two-sided p-value for test of no difference from 0.|MMRM||Oral Semaglutide 7 mg - placebo|The analysis was based on a mixed model for repeated measurements (MMRM) that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 26. The independent effects were treatment and region as categorical fixed effects and the baseline HbA1c value as a covariate, all nested within visit, and an unstructured residual covariance matrix.||-1.0|-1.5|<0.0001
72532540|NCT03808298|144593963|OTHER|Placebo-corrected change-from-baseline PR (ms) at Day 1 1 Hours Post-dose|LS Mean|0.0|STANDARD_ERROR_OF_MEAN|0.96|||TWO_SIDED|90.0|-1.62|1.55||||||||1.55|-1.62|
72532541|NCT03808298|144593963|OTHER|Placebo-corrected change-from-baseline PR (ms) at Day 1 2.5 Hours Post-dose|LS Mean|0.4|STANDARD_ERROR_OF_MEAN|1.0|||TWO_SIDED|90.0|-1.22|2.09||||||||2.09|-1.22|
72532542|NCT03808298|144593963|OTHER|Placebo-corrected change-from-baseline PR (ms) at Day 1 4 Hours Post-dose|LS Mean|-0.4|STANDARD_ERROR_OF_MEAN|1.02|||TWO_SIDED|90.0|-2.04|1.33||||||||1.33|-2.04|
72532543|NCT03808298|144593963|OTHER|Placebo-corrected change-from-baseline PR (ms) at Day 1 8 Hours Post-dose|LS Mean|1.2|STANDARD_ERROR_OF_MEAN|1.31|||TWO_SIDED|90.0|-1.0|3.33||||||||3.33|-1.00|
72532544|NCT03808298|144593963|OTHER|Placebo-corrected change-from-baseline PR (ms) at Day 1 12 Hours Post-dose|LS Mean|0.3|STANDARD_ERROR_OF_MEAN|1.56|||TWO_SIDED|90.0|-2.3|2.88||||||||2.88|-2.30|
72532545|NCT03808298|144593963|OTHER|Placebo-corrected change-from-baseline PR (ms) at Day 1 24 Hours Post-dose|LS Mean|-1.1|STANDARD_ERROR_OF_MEAN|1.15|||TWO_SIDED|90.0|-3.0|0.81||||||||0.81|-3.00|
72532546|NCT03808298|144593963|OTHER|Placebo-corrected change-from-baseline PR (ms) at Day 14 0.75 Hours Pre-dose|LS Mean|0.6|STANDARD_ERROR_OF_MEAN|1.64|||TWO_SIDED|90.0|-2.08|3.35||||||||3.35|-2.08|
72532547|NCT03808298|144593963|OTHER|Placebo-corrected change-from-baseline PR (ms) at Day 14 0.5 Hours Pre-dose|LS Mean|0.3|STANDARD_ERROR_OF_MEAN|1.69|||TWO_SIDED|90.0|-2.48|3.12||||||||3.12|-2.48|
72532548|NCT03808298|144593963|OTHER|Placebo-corrected change-from-baseline PR (ms) at Day 14 0.25 Hours Pre-dose|LS Mean|0.3|STANDARD_ERROR_OF_MEAN|1.69|||TWO_SIDED|90.0|-2.55|3.06||||||||3.06|-2.55|
72532549|NCT03808298|144593963|OTHER|Placebo-corrected change-from-baseline PR (ms) at Day 14 0.5 Hours Post-dose|LS Mean|0.0|STANDARD_ERROR_OF_MEAN|1.9|||TWO_SIDED|90.0|-3.17|3.12||||||||3.12|-3.17|
72532550|NCT03808298|144593963|OTHER|Placebo-corrected change-from-baseline PR (ms) at Day 14 1 Hours Post-dose|LS Mean|0.5|STANDARD_ERROR_OF_MEAN|1.77|||TWO_SIDED|90.0|-2.47|3.37||||||||3.37|-2.47|
72532551|NCT03808298|144593963|OTHER|Placebo-corrected change-from-baseline PR (ms) at Day 14 2.5 Hours Post-dose|LS Mean|-0.5|STANDARD_ERROR_OF_MEAN|1.74|||TWO_SIDED|90.0|-3.42|2.34||||||||2.34|-3.42|
72532552|NCT03808298|144593963|OTHER|Placebo-corrected change-from-baseline PR (ms) at Day 14 4 Hours Post-dose|LS Mean|-0.7|STANDARD_ERROR_OF_MEAN|1.71|||TWO_SIDED|90.0|-3.54|2.12||||||||2.12|-3.54|
72532553|NCT03808298|144593963|OTHER|Placebo-corrected change-from-baseline PR (ms) at Day 14 8 Hours Post-dose|LS Mean|-0.7|STANDARD_ERROR_OF_MEAN|1.57|||TWO_SIDED|90.0|-3.31|1.88||||||||1.88|-3.31|
72532554|NCT03808298|144593963|OTHER|Placebo-corrected change-from-baseline PR (ms) at Day 14 12 Hours Post-dose|LS Mean|1.4|STANDARD_ERROR_OF_MEAN|1.6|||TWO_SIDED|90.0|-1.21|4.09||||||||4.09|-1.21|
72532555|NCT03808298|144593963|OTHER|Placebo-corrected change-from-baseline PR (ms) at Day 14 24 Hours Post-dose|LS Mean|-0.2|STANDARD_ERROR_OF_MEAN|1.63|||TWO_SIDED|90.0|-2.9|2.49||||||||2.49|-2.90|
72626224|NCT00402987|144781742|SUPERIORITY_OR_OTHER_LEGACY|||||||0.018||95.0||||"Analysis at 11 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.018
72532556|NCT03808298|144593963|OTHER|Placebo-corrected change-from-baseline PR (ms) at Day 1 0.5 Hours Post-dose|LS Mean|-0.6|STANDARD_ERROR_OF_MEAN|0.84|||TWO_SIDED|90.0|-2.0|0.77||||||||0.77|-2.00|
72532557|NCT03808298|144593963|OTHER|Placebo-corrected change-from-baseline PR (ms) at Day 1 1 Hours Post-dose|LS Mean|-0.1|STANDARD_ERROR_OF_MEAN|0.97|||TWO_SIDED|90.0|-1.71|1.5||||||||1.50|-1.71|
72532558|NCT03808298|144593963|OTHER|Placebo-corrected change-from-baseline PR (ms) at Day 1 2.5 Hours Post-dose|LS Mean|0.0|STANDARD_ERROR_OF_MEAN|1.02||||90.0|-1.64|1.73||||||||1.73|-1.64|
72532559|NCT03808298|144593963|OTHER|Placebo-corrected change-from-baseline PR (ms) at Day 1 4 Hours Post-dose|LS Mean|-0.7|STANDARD_ERROR_OF_MEAN|1.03|||TWO_SIDED|90.0|-2.39|1.02||||||||1.02|-2.39|
72532560|NCT03808298|144593963|OTHER|Placebo-corrected change-from-baseline PR (ms) at Day 1 8 Hours Post-dose|LS Mean|0.9|STANDARD_ERROR_OF_MEAN|1.33|||TWO_SIDED|90.0|-1.26|3.13||||||||3.13|-1.26|
72532561|NCT03808298|144593963|OTHER|Placebo-corrected change-from-baseline PR (ms) at Day 1 12 Hours Post-dose|LS Mean|-1.3|STANDARD_ERROR_OF_MEAN|1.59||||90.0|-3.92|1.35||||||||1.35|-3.92|
72532562|NCT03808298|144593963|OTHER|Placebo-corrected change-from-baseline PR (ms) at Day 1 24 Hours Post-dose|LS Mean|0.0|STANDARD_ERROR_OF_MEAN|1.16|||TWO_SIDED|90.0|-1.96|1.89||||||||1.89|-1.96|
72532563|NCT03808298|144593963|OTHER|Placebo-corrected change-from-baseline PR (ms) at Day 14 0.75 Hours Pre-dose|LS Mean|1.4|STANDARD_ERROR_OF_MEAN|1.65|||TWO_SIDED|90.0|-1.34|4.13||||||||4.13|-1.34|
72532564|NCT03808298|144593963|OTHER|Placebo-corrected change-from-baseline PR (ms) at Day 14 0.5 Hours Pre-dose|LS Mean|1.2|STANDARD_ERROR_OF_MEAN|1.71|||TWO_SIDED|90.0|-1.61|4.05||||||||4.05|-1.61|
72532565|NCT03808298|144593963|OTHER|Placebo-corrected change-from-baseline PR (ms) at Day 14 0.25 Hours Pre-dose|LS Mean|1.5|STANDARD_ERROR_OF_MEAN|1.71|||TWO_SIDED|90.0|-1.32|4.35||||||||4.35|-1.32|
72532566|NCT03808298|144593963|OTHER|Placebo-corrected change-from-baseline PR (ms) at Day 14 0.5 Hours Post-dose|LS Mean|-0.2|STANDARD_ERROR_OF_MEAN|1.92|||TWO_SIDED|90.0|-3.38|2.97||||||||2.97|-3.38|
72532567|NCT03808298|144593963|OTHER|Placebo-corrected change-from-baseline PR (ms) at Day 14 1 Hours Pre-dose|LS Mean|-0.5|STANDARD_ERROR_OF_MEAN|1.78||||90.0|-3.48|2.42||||||||2.42|-3.48|
72532568|NCT03808298|144593963|OTHER|Placebo-corrected change-from-baseline PR (ms) at Day 14 2.5 Hours Post-dose|LS Mean|1.1|STANDARD_ERROR_OF_MEAN|1.76|||TWO_SIDED|90.0|-1.81|4.02||||||||4.02|-1.81|
72532569|NCT03808298|144593963|OTHER|Placebo-corrected change-from-baseline PR (ms) at Day 14 4 Hours Post-dose|LS Mean|1.2|STANDARD_ERROR_OF_MEAN|1.72|||TWO_SIDED|90.0|-1.67|4.04||||||||4.04|-1.67|
72532570|NCT03808298|144593963|OTHER|Placebo-corrected change-from-baseline PR (ms) at Day 14 8 Hours Post-dose|LS Mean|0.7|STANDARD_ERROR_OF_MEAN|1.58|||TWO_SIDED|90.0|-1.95|3.29||||||||3.29|-1.95|
72532571|NCT03808298|144593963|OTHER|Placebo-corrected change-from-baseline PR (ms) at Day 14 12 Hours Post-dose|LS Mean|3.3|STANDARD_ERROR_OF_MEAN|1.62|||TWO_SIDED|90.0|0.6|5.96||||||||5.96|0.60|
72532572|NCT03808298|144593963|OTHER|Placebo-corrected change-from-baseline PR (ms) at Day 14 24 Hours Post-dose|LS Mean|2.0|STANDARD_ERROR_OF_MEAN|1.64|||TWO_SIDED|90.0|-0.72|4.72||||||||4.72|-0.72|
72532573|NCT03808298|144593964|OTHER|Placebo-corrected change-from-baseline QRS (ms) at Day 1 0.5 Hours Post-dose|LS Mean|-0.1|STANDARD_ERROR_OF_MEAN|0.11|||TWO_SIDED|90.0|-0.29|0.07||||||||0.07|-0.29|
72532574|NCT03808298|144593964|OTHER|Placebo-corrected change-from-baseline QRS (ms) at Day 1 1 Hours Post-dose|LS Mean|0.2|STANDARD_ERROR_OF_MEAN|0.11|||TWO_SIDED|90.0|-0.02|0.34||||||||0.34|-0.02|
72532575|NCT03808298|144593964|OTHER|Placebo-corrected change-from-baseline (ms) at QRS Day 1 2.5 Hours Post-dose|LS Mean|-0.1|STANDARD_ERROR_OF_MEAN|0.13|||TWO_SIDED|90.0|-0.3|0.12||||||||0.12|-0.30|
72532576|NCT03808298|144593964|OTHER|Placebo-corrected change-from-baseline QRS (ms) at Day 1 4 Hours Post-dose|LS Mean|0.0|STANDARD_ERROR_OF_MEAN|0.13|||TWO_SIDED|90.0|-0.26|0.18||||||||0.18|-0.26|
72532577|NCT03808298|144593964|OTHER|Placebo-corrected change-from-baseline QRS (ms) at Day 1 8 Hours Post-dose|LS Mean|-0.1|STANDARD_ERROR_OF_MEAN|0.29|||TWO_SIDED|90.0|-0.57|0.38||||||||0.38|-0.57|
72532578|NCT03808298|144593964|OTHER|Placebo-corrected change-from-baseline QRS (ms) at Day 1 12 Hours Post-dose|LS Mean|0.0|STANDARD_ERROR_OF_MEAN|0.37|||TWO_SIDED|90.0|-0.65|0.56||||||||0.56|-0.65|
72532579|NCT03808298|144593964|OTHER|Placebo-corrected change-from-baseline QRS (ms) at Day 1 24 Hours Post-dose|LS Mean|0.1|STANDARD_ERROR_OF_MEAN|0.15||||90.0|-0.11|0.4||||||||0.40|-0.11|
72532580|NCT03808298|144593964|OTHER|Placebo-corrected change-from-baseline QRS (ms) at Day 14 0.75 Hours Pre-dose|LS Mean|0.2|STANDARD_ERROR_OF_MEAN|0.33|||TWO_SIDED|90.0|-0.34|0.74||||||||0.74|-0.34|
72532581|NCT03808298|144593964|OTHER|Placebo-corrected change-from-baseline QRS (ms) at Day 14 0.5 Hours Pre-dose|LS Mean|0.4|STANDARD_ERROR_OF_MEAN|0.33|||TWO_SIDED|90.0|-0.17|0.91||||||||0.91|-0.17|
72532582|NCT03808298|144593964|OTHER|Placebo-corrected change-from-baseline QRS (ms) at Day 14 0.25 Hours Pre-dose|LS Mean|0.5|STANDARD_ERROR_OF_MEAN|0.33|||TWO_SIDED|90.0|-0.04|1.05||||||||1.05|-0.04|
72532583|NCT03808298|144593964|OTHER|Placebo-corrected change-from-baseline QRS (ms) at Day 14 0.5 Hours Post-dose|LS Mean|0.3|STANDARD_ERROR_OF_MEAN|0.33|||TWO_SIDED|90.0|-0.26|0.82||||||||0.82|-0.26|
72532584|NCT03808298|144593964|OTHER|Placebo-corrected change-from-baseline QRS (ms) at Day 14 1 Hours Post-dose|LS Mean|0.4|STANDARD_ERROR_OF_MEAN|32.0|||TWO_SIDED|90.0|-0.18|0.9||||||||0.90|-0.18|
72532585|NCT03808298|144593964|OTHER||LS Mean|0.5|STANDARD_ERROR_OF_MEAN|0.33|||TWO_SIDED|90.0|-0.08|1.0||||||Placebo-corrected change-from-baseline QRS (ms) at Day 14 2.5 Hours Post-dose||1.00|-0.08|
72532586|NCT03808298|144593964|OTHER|Placebo-corrected change-from-baseline QRS (ms) at Day 14 4 Hours Post-dose|LS Mean|0.4|STANDARD_ERROR_OF_MEAN|0.34|||TWO_SIDED|90.0|-0.19|0.94||||||||0.94|-0.19|
72532587|NCT03808298|144593964|OTHER|Placebo-corrected change-from-baseline QRS (ms) at Day 14 8 Hours Post-dose|LS Mean|0.4|STANDARD_ERROR_OF_MEAN|0.43|||TWO_SIDED|90.0|-0.33|1.1||||||||1.10|-0.33|
72532588|NCT03808298|144593964|OTHER|Placebo-corrected change-from-baseline QRS (ms) at Day 14 12 Hours Post-dose|LS Mean|0.3|STANDARD_ERROR_OF_MEAN|0.47|||TWO_SIDED|90.0|-0.5|1.06||||||||1.06|-0.50|
72532589|NCT03808298|144593964|OTHER|Placebo-corrected change-from-baseline QRS (ms) at Day 14 24 Hours Post-dose|LS Mean|0.5|STANDARD_ERROR_OF_MEAN|0.35|||TWO_SIDED|90.0|-0.06|1.11||||||||1.11|-0.06|
72532590|NCT03808298|144593964|OTHER|Placebo-corrected change-from-baseline QRS (ms) at Day 1 0.5 Hours Post-dose|LS Mean|-0.1|STANDARD_ERROR_OF_MEAN|0.11|||TWO_SIDED|90.0|-0.25|0.11||||||||0.11|-0.25|
72532591|NCT03808298|144593964|OTHER|Placebo-corrected change-from-baseline QRS (ms) at Day 1 1 Hours Post-dose|LS Mean|0.2|STANDARD_ERROR_OF_MEAN|0.11|||TWO_SIDED|90.0|0.0|0.36||||||||0.36|0.00|
72532592|NCT03808298|144593964|OTHER|Placebo-corrected change-from-baseline QRS (ms) at Day 1 2.5 Hours Post-dose|LS Mean|-0.1|STANDARD_ERROR_OF_MEAN|0.13|||TWO_SIDED|90.0|-0.34|0.09||||||||0.09|-0.34|
72532593|NCT03808298|144593964|OTHER|Placebo-corrected change-from-baseline QRS (ms) at Day 1 4 Hours Post-dose|LS Mean|0.1|STANDARD_ERROR_OF_MEAN|0.13|||TWO_SIDED|90.0|-0.1|0.34||||||||0.34|-0.10|
72532594|NCT03808298|144593964|OTHER|Placebo-corrected change-from-baseline QRS (ms) at Day 1 8 Hours Post-dose|LS Mean|0.1|STANDARD_ERROR_OF_MEAN|0.29|||TWO_SIDED|90.0|-0.4|0.57||||||||0.57|-0.40|
72532595|NCT03808298|144593964|OTHER|Placebo-corrected change-from-baseline QRS (ms) at Day 1 12 Hours Post-dose|LS Mean|0.3|STANDARD_ERROR_OF_MEAN|0.37|||TWO_SIDED|90.0|-0.31|0.93||||||||0.93|-0.31|
72626225|NCT00402987|144781742|SUPERIORITY_OR_OTHER_LEGACY|||||||0.741||95.0||||"Analysis at 11 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.741
72532596|NCT03808298|144593964|OTHER|Placebo-corrected change-from-baseline QRS (ms) at Day 1 24 Hours Post-dose|LS Mean|0.3|STANDARD_ERROR_OF_MEAN|0.16|||TWO_SIDED|90.0|0.07|0.58||||||||0.58|0.07|
72532597|NCT03808298|144593964|OTHER|Placebo-corrected change-from-baseline QRS (ms) at Day 14 0.75 Hours Pre-dose|LS Mean|0.4|STANDARD_ERROR_OF_MEAN|0.33|||TWO_SIDED|90.0|-0.19|0.9||||||||0.90|-0.19|
72532598|NCT03808298|144593964|OTHER|Placebo-corrected change-from-baseline QRS (ms) at Day 14 0.5 Hours Pre-dose|LS Mean|0.4|STANDARD_ERROR_OF_MEAN|0.33|||TWO_SIDED|90.0|-0.11|0.98||||||||0.98|-0.11|
72532599|NCT03808298|144593964|OTHER|Placebo-corrected change-from-baseline QRS (ms) at Day 14 0.25 Hours Pre-dose|LS Mean|0.5|STANDARD_ERROR_OF_MEAN|0.33|||TWO_SIDED|90.0|-0.06|1.05||||||||1.05|-0.06|
72532600|NCT03808298|144593964|OTHER|Placebo-corrected change-from-baseline QRS (ms) at Day 14 0.5 Hours Post-dose|LS Mean|0.3|STANDARD_ERROR_OF_MEAN|0.33|||TWO_SIDED|90.0|-0.27|0.82||||||||0.82|-0.27|
72532601|NCT03808298|144593964|OTHER|Placebo-corrected change-from-baseline QRS (ms) at Day 14 1 Hours Post-dose|LS Mean|0.4|STANDARD_ERROR_OF_MEAN|0.33|||TWO_SIDED|90.0|-0.14|0.94||||||||0.94|-0.14|
72532602|NCT03808298|144593964|OTHER|Placebo-corrected change-from-baseline QRS (ms) at Day 14 2.5 Hours Post-dose|LS Mean|0.3|STANDARD_ERROR_OF_MEAN|0.33|||TWO_SIDED|90.0|-0.24|0.86||||||||0.86|-0.24|
72532603|NCT03808298|144593964|OTHER|Placebo-corrected change-from-baseline QRS (ms) at Day 14 4 Hours Post-dose|LS Mean|0.6|STANDARD_ERROR_OF_MEAN|0.34|||TWO_SIDED|90.0|0.07|1.2||||||||1.20|0.07|
72532604|NCT03808298|144593964|OTHER|Placebo-corrected change-from-baseline QRS (ms) at Day 14 8 Hours Post-dose|LS Mean|0.6|STANDARD_ERROR_OF_MEAN|0.44|||TWO_SIDED|90.0|-0.1|1.35||||||||1.35|-0.10|
72532605|NCT03808298|144593964|OTHER|Placebo-corrected change-from-baseline QRS (ms) at Day 14 12 Hours Post-dose|LS Mean|0.3|STANDARD_ERROR_OF_MEAN|0.48|||TWO_SIDED|90.0|-0.5|1.07||||||||1.07|-0.50|
72532606|NCT03808298|144593964|OTHER|Placebo-corrected change-from-baseline QRS (ms) at Day 14 24 Hours Post-dose|LS Mean|0.5|STANDARD_ERROR_OF_MEAN|0.36|||TWO_SIDED|90.0|-0.14|1.04||||||||1.04|-0.14|
72532607|NCT03808298|144593986|OTHER|Placebo-corrected change-from-baseline QTcF (ms) at 0.5 Hours Post-dose|LS Mean|1.2|STANDARD_ERROR_OF_MEAN|1.71|||TWO_SIDED|90.0|-1.64|4.04||||||||4.04|-1.64|
72532608|NCT03808298|144593986|OTHER|Placebo-corrected change-from-baseline QTcF (ms) at 1 Hours Post-dose|LS Mean|5.4|STANDARD_ERROR_OF_MEAN|1.93|||TWO_SIDED|90.0|2.22|8.63||||||||8.63|2.22|
72532609|NCT03808298|144593986|OTHER|Placebo-corrected change-from-baseline QTcF (ms) at 2.5 Hours Post-dose|LS Mean|8.5|STANDARD_ERROR_OF_MEAN|1.64|||TWO_SIDED|90.0|5.81|11.28||||||||11.28|5.81|
72532610|NCT03808298|144593986|OTHER|Placebo-corrected change-from-baseline QTcF (ms) at 4 Hours Post-dose|LS Mean|8.6|STANDARD_ERROR_OF_MEAN|1.65|||TWO_SIDED|90.0|5.86|11.34||||||||11.34|5.86|
72532611|NCT03808298|144593986|OTHER|Placebo-corrected change-from-baseline QTcF (ms) at 8 Hours Post-dose|LS Mean|8.5|STANDARD_ERROR_OF_MEAN|1.86|||TWO_SIDED|90.0|5.43|11.61||||||||11.61|5.43|
72532612|NCT03808298|144593986|OTHER|Placebo-corrected change-from-baseline QTcF (ms) at 12 Hours Post-dose|LS Mean|6.9|STANDARD_ERROR_OF_MEAN|1.88|||TWO_SIDED|90.0|3.76|10.0||||||||10.00|3.76|
72532613|NCT03808298|144593986|OTHER|Placebo-corrected change-from-baseline QTcF (ms) at 24 Hours Post-dose|LS Mean|6.1|STANDARD_ERROR_OF_MEAN|1.52|||TWO_SIDED|90.0|3.58|8.62||||||||8.62|3.58|
72532614|NCT03159455|144593993|OTHER||Slope|2.2305|STANDARD_ERROR_OF_MEAN|0.2592|||TWO_SIDED|95.0|1.6955|2.7655|||||Dose proportionality was explored using the power model.The perfect dose proportionality would correspond to a slope β of 1. PK endpoints on the log-transformed scale.|This was non confirmatory testing (Single dose). Dose proportionality of tablets for AUC0-24 was analysed in Japanese subjects.|Standard error of mean is standard error of slope.|2.7655|1.6955|
72532615|NCT03159455|144593994|OTHER||Slope|1.9007|STANDARD_ERROR_OF_MEAN|0.2382|||TWO_SIDED|95.0|1.4102|2.3912|||||Dose proportionality was explored using the power model.The perfect dose proportionality would correspond to a slope β of 1. PK endpoints on the log-transformed scale.|This was non confirmatory testing (Single dose). Dose proportionality of tablets for Cmax was analysed in Japanese subjects.|Standard error of mean is standard error of slope.|2.3912|1.4102|
72532616|NCT03159455|144593995|OTHER||Slope|3.244|STANDARD_ERROR_OF_MEAN|0.1771|||TWO_SIDED|95.0|2.8793|3.6087|||||Dose proportionality was explored using the power model.The perfect dose proportionality would correspond to a slope β of 1. PK endpoints on the log-transformed scale.|This was non confirmatory testing on Day 28 (after multiple doses). Dose proportionality of tablets for AUC0-24,28 was analysed in Japanese subjects.|Standard error of mean is standard error of slope.|3.6087|2.8793|
72626226|NCT00402987|144781742|SUPERIORITY_OR_OTHER_LEGACY|||||||0.326||95.0||||"Analysis at 11 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.326
72626227|NCT00402987|144781742|SUPERIORITY_OR_OTHER_LEGACY|||||||0.256||95.0||||"Analysis at 11 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.256
72572353|NCT02906930|144671987|SUPERIORITY|This hypothesis was not controlled for multiplicity. Results are based on the data from the on-treatment without rescue medication observation period. The estimated treatment effect excludes the effect of any rescue medication (hypothetical estimand).|Mean treatment difference|-1.4|||<|0.0001|TWO_SIDED|95.0|-1.7|-1.2||Unadjusted two-sided p-value for test of no difference from 0.|MMRM||Oral Semaglutide 14 mg - placebo|The analysis was based on a mixed model for repeated measurements (MMRM) that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 26. The independent effects were treatment and region as categorical fixed effects and the baseline HbA1c value as a covariate, all nested within visit, and an unstructured residual covariance matrix.||-1.2|-1.7|<0.0001
72572354|NCT02906930|144671988|SUPERIORITY|This hypothesis was controlled for multiplicity. Results are based on the data from the in-trial observation period. The estimated treatment effect includes the effect of any additional anti-diabetic medication for all randomised subjects regardless of premature trial product discontinuation (treatment policy estimand).|Mean treatment difference|-2.3|||<|0.0001|TWO_SIDED|95.0|-3.1|-1.5||Unadjusted two-sided p-value for test of no difference from 0.|Pattern mixed model||Oral Semaglutide 14 mg - Placebo|The analysis was based on a pattern mixture model using multiple imputation to impute missing data for week 26, assuming that the missing data mechanism was missing at random within the groups used for the imputation. The imputed data sets were analysed using an ANCOVA model with treatment and region as categorical fixed effects and baseline body weight value as covariate for each of the 1000 imputed complete data sets, and pooled by Rubin's rule to draw inference.||-1.5|-3.1|<0.0001
72572355|NCT02906930|144671988|SUPERIORITY|This hypothesis was controlled for multiplicity. Results are based on the data from the in-trial observation period. The estimated treatment effect includes the effect of any additional anti-diabetic medication for all randomised subjects regardless of premature trial product discontinuation (treatment policy estimand).|Mean treatment difference|-0.9||||0.0866|TWO_SIDED|95.0|-1.9|0.1||Unadjusted two-sided p-value for test of no difference from 0.|Pattern mixed model||Oral Semaglutide 7 mg - Placebo|The analysis was based on a pattern mixture model using multiple imputation to impute missing data for week 26, assuming that the missing data mechanism was missing at random within the groups used for the imputation. The imputed data sets were analysed using an ANCOVA model with treatment and region as categorical fixed effects and baseline body weight value as covariate for each of the 1000 imputed complete data sets, and pooled by Rubin's rule to draw inference.||0.1|-1.9|0.0866
72576770|NCT00261443|144680647|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.22||||0.039|TWO_SIDED|95.0|-0.43|-0.01||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 40 Comparison||-0.01|-0.43|0.039
72626228|NCT00402987|144781742|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 12 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
72626229|NCT00402987|144781742|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001||95.0||||"Analysis at 12 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.001
72626230|NCT00402987|144781742|SUPERIORITY_OR_OTHER_LEGACY|||||||0.016||95.0||||"Analysis at 12 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.016
72532617|NCT03159455|144593996|OTHER||Slope|2.0711|STANDARD_ERROR_OF_MEAN|0.148|||TWO_SIDED|95.0|1.7663|2.376|||||Dose proportionality was explored using the power model.The perfect dose proportionality would correspond to a slope β of 1. PK endpoints on the log-transformed scale.|This was non confirmatory testing on Day 28 (after multiple doses). Dose proportionality of tablets for Cmax,28 was analysed in Japanese subjects.|Standard error of mean is standard error of slope.|2.3760|1.7663|
72532618|NCT05040295|144593998|EQUIVALENCE|The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.|Ratio of adjust geometric means|102.5|||||TWO_SIDED|90.0|94.21|111.51|||||Reference = Treatment A Test = Treatment B Ratio=Test/Reference|AUCinf was analyzed using a mixed effects model with sequence and treatment as fixed effects and participant within sequence as a random effect. Estimates of the adjusted mean differences (Test-Reference) and corresponding 90% confidence intervals (CIs) were obtained from the model.||111.51|94.21|
72626231|NCT00402987|144781742|SUPERIORITY_OR_OTHER_LEGACY|||||||0.808||95.0||||"Analysis at 12 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.808
72532619|NCT05040295|144593998|EQUIVALENCE|The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.|Ratio of adjust geometric means|106.65|||||TWO_SIDED|90.0|100.07|113.66|||||Reference = Treatment A Test = Treatment C Ratio=Test/Reference|AUCinf was analyzed using a mixed effects model with sequence and treatment as fixed effects and participant within sequence as a random effect. Estimates of the adjusted mean differences (Test-Reference) and corresponding 90% confidence intervals (CIs) were obtained from the model.||113.66|100.07|
72532620|NCT05040295|144593999|EQUIVALENCE|The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.|Ratio of adjust geometric means|101.12|||||TWO_SIDED|90.0|88.25|115.87|||||Reference = Treatment A Test = Treatment B Ratio=Test/Reference|Cmax was analyzed using a mixed effects model with sequence and treatment as fixed effects and participant within sequence as a random effect. Estimates of the adjusted mean differences (Test-Reference) and corresponding 90% confidence intervals (CIs) were obtained from the model.||115.87|88.25|
72532621|NCT05040295|144593999|EQUIVALENCE|The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.|Ratio of adjust geometric means|90.11|||||TWO_SIDED|90.0|78.49|103.44|||||Reference = Treatment A Test = Treatment C Ratio=Test/Reference|Cmax was analyzed using a mixed effects model with sequence and treatment as fixed effects and participant within sequence as a random effect. Estimates of the adjusted mean differences (Test-Reference) and corresponding 90% confidence intervals (CIs) were obtained from the model.||103.44|78.49|
72532622|NCT00953849|144594002|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|A Student's t test was performed to determine significance of differences between each of two groups.||||||<0.05
72532623|NCT00953849|144594003|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|A Student's t test was performed to determine significance of differences between each of two groups.||||||<0.05
72532624|NCT00953849|144594004|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|A Student's t test was performed to determine significance of differences between each of two groups.||||||<0.05
72532625|NCT00953849|144594005|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|A Student's t test was performed to determine significance of differences between each of two groups.||||||<0.05
72532626|NCT01801475|144594006|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Chi-squared|||The nonlinear mixed-effects modeling software program NONMEM (version VII; Icon Development Solutions, Ellicott City, MD) was used to estimate the pharmacokinetic parameters. The first-order conditional estimation (FOCE) with η-ε interaction was used for the estimation process. Volume and clearance in this model is computed as a mean of the study population (pregnant and non-pregnant women) with a log-normal distribution in the population.||||<0.05
72532627|NCT01801475|144594007|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Chi-squared|||The nonlinear mixed-effects modeling software program NONMEM (version VII; Icon Development Solutions, Ellicott City, MD) was used to estimate the pharmacokinetic parameters. The first-order conditional estimation (FOCE) with η-ε interaction was used for the estimation process. Volume and clearance in this model is computed as a mean of the study population (pregnant and non-pregnant women) with a log-normal distribution in the population.||||<0.05
72532628|NCT00421928|144594008|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|0.18|<|0.05||95.0|-1.04|-0.33|||ANCOVA|Analysis of covariance (ANCOVA) model was used with treatment and pooled analysis center as factors and baseline pain intensity score as a covariate.||The primary null hypothesis to be tested for the study was that the tapentadol ER group was not different from the placebo group for the primary endpoint. Assuming the mean treatment group difference of 0.7 with an SD of 2.7, 314 subjects per treatment group were estimated to provide 90% power to show that the tapentadol ER group was statistically different from placebo at an alpha level of 0.05. The total number of subjects to be randomly assigned to a treatment group for the study was 942.||-0.33|-1.04|<0.05
72532629|NCT00444028|144594020|OTHER|"The units on such analyses are generally those of slope (rise over run), with 1.000 being perfect. Although any positive slope might be considered clinically useful, a 90% CI within the criteria of 0.800-1.250 may be considered a delivery system which is as good as it gets."|Slope|0.909|||||TWO_SIDED|90.0|0.832|0.987||||||Dose proportionality by power analysis examines the linear regression of the log-AUC versus log-Dose on a by-patient basis across all doses administered. The slope and 90% confidence interval (CI) provide a clear, quantitative (best practices) assessment of the relationship of drug delivered to dose administered.||0.987|0.832|
72532630|NCT05056311|144594025|SUPERIORITY|||||||0.001||||||The a priori threshold for statistical significance was \<0.05.|t-test, 2 sided|||||||0.001
72532631|NCT05056311|144594026|SUPERIORITY|||||||0.001||||||The a priori threshold for statistical significance was \<0.05.|t-test, 2 sided|||||||0.001
72532632|NCT05056311|144594027|SUPERIORITY|||||||0.001||||||The a priori threshold for statistical significance was \<0.05.|t-test, 2 sided|||||||0.001
72532633|NCT05056311|144594029|SUPERIORITY|||||||0.0001||||||The a priori threshold for statistical significance was \<0.05.|t-test, 2 sided|||||||0.0001
72532634|NCT05056311|144594030|SUPERIORITY|||||||0.6374||||||The a priori threshold for statistical significance was \<0.05.|McNemar|||||||0.6374
72576771|NCT00261443|144680647|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.27||||0.015|TWO_SIDED|95.0|-0.48|-0.05||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 44 Comparison||-0.05|-0.48|0.015
72576772|NCT00261443|144680647|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.29||||0.009|TWO_SIDED|95.0|-0.5|-0.07||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 48 Comparison||-0.07|-0.50|0.009
72626232|NCT00402987|144781742|SUPERIORITY_OR_OTHER_LEGACY|||||||0.394||95.0||||"Analysis at 12 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.394
72532635|NCT03799198|144594035|SUPERIORITY||Treatment Difference|-3.5|STANDARD_ERROR_OF_MEAN|1.02|<|0.001|TWO_SIDED|95.0|-5.51|-1.5|||ANCOVA|||Analysis of in-trial data with missing observations for body weight at month 12 imputed from the WMP arm based on a jump to reference multiple (x=100) imputation approach. Percent change in body weight from baseline to month 12 was calculated for each study participant within the FAS and analyzed using an analysis of covariance model with randomized treatment as a factor and baseline body weight (kg) as a covariate.||-1.50|-5.51|<0.001
72532636|NCT00351611|144594081|NON_INFERIORITY|Non-inferiority was demonstrated if the upper CI bound was less than 0.10 (10%).|Difference in percentage of participants|-1.7094|||||TWO_SIDED|95.0|-9.1751|5.9784||||||A 2-sided 95 percent (%) confidence interval (CI) on the difference in percentage of participants, between pregabalin and placebo was constructed using unconditional exact methods.||5.9784|-9.1751|
72532637|NCT00351611|144594082|NON_INFERIORITY|Non-inferiority with respect to mean deviation was demonstrated if the lower bound of the CI is greater than -2.0 decibels.|Difference in LS mean|-0.125||||0.4414|TWO_SIDED|95.0|-0.443|0.194|||ANCOVA|||Analysis of covariance (ANCOVA) with treatment and center in the model and the baseline mean deviation as the covariate was used to construct a 2-sided 95% CI on the difference in least squares (LS) mean between pregabalin and placebo.||0.194|-0.443|0.4414
72532638|NCT00351611|144594083|OTHER||Difference in LS mean|-0.9||||0.1346|TWO_SIDED|95.0|-2.083|0.283|||ANCOVA|||ANCOVA with treatment and center in the model and the baseline visual acuity as the covariate was used to construct a 2-sided 95% confidence interval on the difference in LS mean between pregabalin and placebo.||0.283|-2.083|0.1346
72532639|NCT03301272|144594089|OTHER||Difference in differences|0.0||||0.5|TWO_SIDED|||||The threshold for statistical significance is 0.05|Regression, Linear|||||||0.5
72532640|NCT03457701|144594094|SUPERIORITY||Adjusted mean difference.|0.02||||0.9971|TWO_SIDED|95.0|-10.13|10.16|||Mixed Models Analysis||Analysis was based on a mixed effects model fitted with fixed effect terms for treatment, period, and iron isotope type and a random participant effect.|The null hypotheses is defined as the difference in fractional iron absorption between treatment arms (Daprodustat - rhEPO \[i.e., epoetin alfa or darbepoetin alfa\]) is equal to zero.||10.16|-10.13|0.9971
72532641|NCT01288911|144594154|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.44|||<|0.0001|TWO_SIDED|95.0|0.34|0.57|||Log Rank||Estimated by use of Cox proportional hazards model.|PFS based on ICR Enzalutamide Vs. Bicalutamide. The (unstratified) log-rank test with an overall significance level of 0.05 (two-sided) was used to compare the PFS of enzalutamide to bicalutamide. The (unstratified) Cox proportional hazards model was used to estimate the hazard ratio of enzalutamide to bicalutamide, calculate the corresponding two-sided 95% confidence intervals and test the hypothesis that the hazard ratio is equal to 1.||0.57|0.34|<0.0001
72532642|NCT01288911|144594155|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.42|||<|0.0001|TWO_SIDED|95.0|0.33|0.55|||Log Rank||Estimated by use of Cox proportional hazards model.|PFS on based investigator assessment Enzalutamide Vs. Bicalutamide.||0.55|0.33|<0.0001
72532643|NCT01288911|144594156|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||Wilcoxon rank sum test|||PSA Response Enzalutamide Vs. Bicalutamide.||||<0.0001
72532644|NCT01288911|144594157|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||Wilcoxon rank sum test|||Best PSA Response Enzalutamide Vs. Bicalutamide.||||<0.0001
72626233|NCT00402987|144781742|SUPERIORITY_OR_OTHER_LEGACY|||||||0.343||95.0||||"Analysis at 12 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.343
72532645|NCT01288911|144594158|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.28|||<|0.0001|TWO_SIDED|95.0|0.2|0.39|||Log Rank||Estimated by use of Cox proportional hazards model.|Time to PSA progression Enzalutamide Vs. Bicalutamide.||0.39|0.20|<0.0001
72369210|NCT00611026|144248555|SUPERIORITY_OR_OTHER|||||||0.013|TWO_SIDED||||||Van Elteren's|P-value based on Van Elteren's Test (a stratified Wilcoxon-Mann Whitney test) adjusted by baseline quartile of voided volume.||Treatment difference fesoterodine vs tolterodine ER at Week 4. Treatment effects estimated by Winsorized means (5% of the tails were censored, ie, replaced with the value at the 5th and 95th percentile, respectively).||||0.0130
72532646|NCT01288911|144594159|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|5.07|||<|0.0001|TWO_SIDED|95.0|3.18|8.09|||Log Rank||Estimated by use of Cox proportional hazards model.|Time to PSA Enzalutamide Vs. Bicalutamide.||8.09|3.18|<0.0001
72532647|NCT01288911|144594160|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|5.55|||<|0.0001|TWO_SIDED|95.0|3.96|7.79|||Log Rank||Estimated by use of Cox proportional hazards model.|Time to ≥ 30% PSA decline from baseline Enzalutamide Vs. Bicalutamide.||7.79|3.96|<0.0001
72532648|NCT01288911|144594161|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|7.01|||<|0.0001|TWO_SIDED|95.0|4.83|10.16|||Log Rank||Estimated by use of Cox proportional hazards model.|Time to ≥ 50% PSA decline from baseline Enzalutamide Vs. Bicalutamide.||10.16|4.83|<0.0001
72532649|NCT01288911|144594162|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|13.91|||<|0.0001|TWO_SIDED|95.0|7.23|26.79|||Log Rank||Estimated by use of Cox proportional hazards model.|Time to ≥ 90% PSA decline from baseline Enzalutamide Vs. Bicalutamide.||26.79|7.23|<0.0001
72532650|NCT01288911|144594163|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.51||||0.0002|TWO_SIDED|95.0|0.36|0.74|||Log Rank||Estimated by use of Cox proportional hazards model.|Radiographic PFS based on ICR Enzalutamide Vs. Bicalutamide.||0.74|0.36|0.0002
72532651|NCT02543918|144594176|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority of the ixekizumab arm to the control arm for the tetanus vaccine was established if the lower limit of the 90% CI excludes an absolute difference of 40% or more.|Mean Difference (Final Values)|1.4|||||TWO_SIDED|90.0|-16.6|19.2||||||Tetanus vaccine responders||19.2|-16.6|
72532652|NCT02543918|144594176|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority of the ixekizumab arm to the control arm for the pneumococcal vaccine was established if the lower limit of the 90% CI excludes an absolute difference of 40% or more.|Mean Difference (Final Values)|-0.8|||||TWO_SIDED|90.0|-12.9|11.0||||||Pneumococcal vaccine responders||11.0|-12.9|
72532653|NCT03026556|144594203|OTHER||Hazard Ratio (HR)|0.766||||0.0844|TWO_SIDED|95.0|0.566|1.037|||Regression, Cox|||Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).||1.037|0.566|0.0844
72576773|NCT00261443|144680647|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.28||||0.013|TWO_SIDED|95.0|-0.5|-0.06||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 52 Comparison||-0.06|-0.50|0.013
72626234|NCT00402987|144781742|SUPERIORITY_OR_OTHER_LEGACY|||||||0.005||95.0||||"Analysis at 24 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.005
72532654|NCT03026556|144594203|OTHER||Hazard Ratio (HR)|1.255||||0.4892|TWO_SIDED|95.0|0.659|2.39|||Regression, Cox|||Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).||2.390|0.659|0.4892
72532655|NCT03026556|144594204|OTHER||Hazard Ratio (HR)|0.82||||0.0182|TWO_SIDED|95.0|0.696|0.967|||Regression, Cox|||Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).||0.967|0.696|0.0182
72532656|NCT03026556|144594204|OTHER||Hazard Ratio (HR)|1.374||||0.0702|TWO_SIDED|95.0|0.974|1.939|||Regression, Cox|||Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).||1.939|0.974|0.0702
72532657|NCT03026556|144594205|OTHER||Hazard Ratio (HR)|0.923||||0.6307|TWO_SIDED|95.0|0.667|1.278|||Regression, Cox|||Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).||1.278|0.667|0.6307
72532658|NCT03026556|144594205|OTHER||Hazard Ratio (HR)|1.054||||0.8777|TWO_SIDED|95.0|0.54|2.055|||Regression, Cox|||Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).||2.055|0.540|0.8777
72532659|NCT03026556|144594206|OTHER||Hazard Ratio (HR)|0.223||||0.0023|TWO_SIDED|95.0|0.085|0.585|||Regression, Cox|||Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).||0.585|0.085|0.0023
72532660|NCT03026556|144594207|OTHER||Hazard Ratio (HR)|0.654||||0.0406|TWO_SIDED|95.0|0.435|0.982|||Regression, Cox|||Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).||0.982|0.435|0.0406
72532661|NCT03026556|144594207|OTHER||Hazard Ratio (HR)|1.11||||0.8124|TWO_SIDED|95.0|0.469|2.63|||Regression, Cox|||Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).||2.630|0.469|0.8124
72532662|NCT03026556|144594208|OTHER||Hazard Ratio (HR)|0.856||||0.0901|TWO_SIDED|95.0|0.716|1.025|||Regression, Cox|||Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).||1.025|0.716|0.0901
72532663|NCT03026556|144594208|OTHER||Hazard Ratio (HR)|1.431||||0.0616|TWO_SIDED|95.0|0.983|2.083|||Regression, Cox|||Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).||2.083|0.983|0.0616
72532664|NCT03026556|144594209|OTHER||Hazard Ratio (HR)|0.887||||0.2073|TWO_SIDED|95.0|0.736|1.069|||Regression, Cox|||Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).||1.069|0.736|0.2073
72532665|NCT03026556|144594209|OTHER||Hazard Ratio (HR)|1.504||||0.0417|TWO_SIDED|95.0|1.015|2.228|||Regression, Cox|||Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).||2.228|1.015|0.0417
72532666|NCT03026556|144594211|OTHER||Hazard Ratio (HR)|0.709||||0.2663|TWO_SIDED|95.0|0.387|1.299|||Regression, Cox|||Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).||1.299|0.387|0.2663
72532667|NCT03026556|144594211|OTHER||Hazard Ratio (HR)|0.864||||0.8112|TWO_SIDED|95.0|0.261|2.863|||Regression, Cox|||Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).||2.863|0.261|0.8112
72532668|NCT03026556|144594212|OTHER||Hazard Ratio (HR)|0.766||||0.1227|TWO_SIDED|95.0|0.546|1.075|||Regression, Cox|||Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).||1.075|0.546|0.1227
72532669|NCT03026556|144594212|OTHER||Hazard Ratio (HR)|1.138||||0.7115|TWO_SIDED|95.0|0.573|2.26|||Regression, Cox|||Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).||2.260|0.573|0.7115
72532670|NCT03026556|144594213|OTHER||Hazard Ratio (HR)|0.923||||0.4727|TWO_SIDED|95.0|0.741|1.149|||Regression, Cox|||Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).||1.149|0.741|0.4727
72532671|NCT03026556|144594213|OTHER||Hazard Ratio (HR)|1.721||||0.0275|TWO_SIDED|95.0|1.062|2.79|||Regression, Cox|||Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).||2.790|1.062|0.0275
72532672|NCT03026556|144594214|OTHER||Hazard Ratio (HR)|1.346||||0.2309|TWO_SIDED|95.0|0.828|2.189|||Regression, Cox|||Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).||2.189|0.828|0.2309
72576774|NCT00261443|144680648|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.348||||0.013|TWO_SIDED|95.0|0.146|0.829||Stratified Log-rank Test, controlling for type of mood stabilizer and type of index mood episode.|Stratified Log-rank Test||Cox proportional hazards model, with type of mood stabilizer and type of index mood episode as stratification factors, and treatment group as covariate.|||0.829|0.146|0.013
72532673|NCT03026556|144594214|OTHER||Hazard Ratio (HR)|1.557||||0.3333|TWO_SIDED|95.0|0.635|3.821|||Regression, Cox|||Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).||3.821|0.635|0.3333
72532674|NCT03026556|144594215|OTHER||Hazard Ratio (HR)|1.008||||0.9359|TWO_SIDED|95.0|0.829|1.226|||Regression, Cox|||Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).||1.226|0.829|0.9359
72626235|NCT00402987|144781742|SUPERIORITY_OR_OTHER_LEGACY|||||||0.029||95.0||||"Analysis at 24 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.029
72532675|NCT03026556|144594215|OTHER||Hazard Ratio (HR)|1.024||||0.8947|TWO_SIDED|95.0|0.716|1.465|||Regression, Cox|||Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).||1.465|0.716|0.8947
72532676|NCT01294319|144594216|SUPERIORITY|||||||0.4872|||||||Fisher Exact|||||||0.4872
72532677|NCT01294319|144594217|SUPERIORITY|||||||0.2786|||||||t-test, 2 sided|||||||0.2786
72532678|NCT02924129|144594218|NON_INFERIORITY|non-inferiority margin (δ) of 10%|||||<|0.001||||||Significance threshold (α) of 0.05|normal approximation to the binomial|||||||<0.001
72532679|NCT02924129|144594219|NON_INFERIORITY|non-inferiority margin (δ) of 10%|Mean Difference (Final Values)|9.0|||<|0.001|TWO_SIDED|95.0|-2.4|20.4||significance threshold (α) of 0.05|t-test, 2 sided|||||20.4|-2.4|<0.001
72532680|NCT02924129|144594220|NON_INFERIORITY|non-inferiority margin (δ) of 10%|Mean Difference (Final Values)|14.6|||<|0.001|TWO_SIDED|95.0|2.9|26.3||significance threshold (α) of 0.05|t-test, 2 sided|||||26.3|2.9|<0.001
72532681|NCT02924129|144594221|NON_INFERIORITY|non-inferiority margin (δ) of 10%||||||0.002||||||significance threshold (α) of 0.05|normal approximation to the binomial|||||||0.002
72532682|NCT02924129|144594222|NON_INFERIORITY|non-inferiority margin (δ) of 10%|||||<|0.001||||||significance threshold (α) of 0.05|normal approximation to the binomial|||||||<0.001
72626236|NCT00402987|144781742|SUPERIORITY_OR_OTHER_LEGACY|||||||0.023||95.0||||"Analysis at 24 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.023
72626237|NCT00402987|144781742|SUPERIORITY_OR_OTHER_LEGACY|||||||0.892||95.0||||"Analysis at 24 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.892
72532683|NCT02924129|144594223|NON_INFERIORITY|non-inferiority margin (δ) of 10%|||||<|0.001||||||significance threshold (α) of 0.05|normal approximation to the binomial|||||||<0.001
72532684|NCT02924129|144594224|NON_INFERIORITY|non-inferiority margin (δ) of 10%|Mean Difference (Final Values)|10.7|||<|0.001|TWO_SIDED|95.0|-1.8|23.3||significance threshold (α) of 0.05|t-test, 2 sided|||||23.3|-1.8|<0.001
72532685|NCT02924129|144594225|NON_INFERIORITY|non-inferiority margin (δ) of 10%|Mean Difference (Final Values)|15.4|||<|0.001|TWO_SIDED|95.0|2.5|28.3||significance threshold (α) of 0.05|t-test, 2 sided|||||28.3|2.5|<0.001
72532686|NCT02924129|144594226|NON_INFERIORITY|non-inferiority margin (δ) of 10%|||||<|0.001|||||||normal approximation to the binomial|||||||<0.001
72532687|NCT02924129|144594227|NON_INFERIORITY|non-inferiority margin (δ) of 10%|||||<|0.001||||||significance threshold (α) of 0.05|normal approximation to the binomial|||||||<0.001
72532688|NCT01000311|144594294|SUPERIORITY_OR_OTHER||Lower limit of 95% confidence interval|83.0|||||TWO_SIDED|95.0|83.0|93.0||||||The null hypothesis associated with the primary objective was that the immune response was considered sufficient if the lower limit of the two-sided 95% confidence intervals (CIs) for the percentage of subjects with hSBA titer ≥1:8, at one month after 4th dose was greater than 80% for the serogroup A.||93|83|
72532689|NCT01000311|144594294|SUPERIORITY_OR_OTHER||Lower limit of 95% confidence interval|90.0|||||TWO_SIDED|95.0|90.0|98.0||||||The null hypothesis associated with the primary objective was that the immune response was considered sufficient if the lower limit of the two-sided 95% CI for the percentage of subjects with hSBA titer ≥1:8, at one month after 4th dose was greater than 85% for the serogroup C.||98|90|
72532690|NCT01000311|144594294|SUPERIORITY_OR_OTHER||Lower limit of 95% confidence interval|93.0|||||TWO_SIDED|95.0|93.0|99.0||||||The null hypothesis associated with the primary objective was that the immune response was considered sufficient if the lower limit of the two-sided 95% CI for the percentage of subjects with hSBA titer ≥1:8, at one month after 4th dose was greater than 85% for the serogroup W.||99|93|
72532691|NCT01000311|144594294|SUPERIORITY_OR_OTHER||Lowe limit of 95% confidence interval|92.0|||||TWO_SIDED|95.0|92.0|99.0||||||The null hypothesis associated with the primary objective was that the immune response was considered sufficient if the lower limit of the two-sided 95% CI for the percentage of subjects with hSBA titer ≥1:8, at one month after 4th dose was greater than 85% for the serogroup Y.||99|92|
72532692|NCT01000311|144594298|NON_INFERIORITY_OR_EQUIVALENCE|The immune seroresponse to diphtheria toxin, when DTaP is given concomitantly with MenACWY-CRM, was considered non-inferior to that of DTaP given alone, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than or equal to -10%.|Group difference|0.0|||||TWO_SIDED|95.0|-2.9|2.6|||Miettinen and Nurminen|||To demonstrate the non-inferiority of seroresponse to diphtheria toxin, when DTaP vaccine is given with MenACWY-CRM compared with when DTaP vaccine is given alone||2.6|-2.9|
72532693|NCT01000311|144594298|NON_INFERIORITY_OR_EQUIVALENCE|The immune seroresponse to tetanus toxin, when DTaP is given concomitantly with MenACWY-CRM, was considered non-inferior to that of DTaP given alone, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than or equal to -10%.|Group difference|0.0|||||TWO_SIDED|95.0|-3.3|3.9|||Miettinen and Nurminen|||To demonstrate the non-inferiority of seroresponse to tetanus toxin, when DTaP vaccine is given with MenACWY-CRM compared with when DTaP vaccine is given alone||3.9|-3.3|
72626238|NCT00402987|144781742|SUPERIORITY_OR_OTHER_LEGACY|||||||0.952||95.0||||"Analysis at 24 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.952
72532694|NCT01000311|144594298|NON_INFERIORITY_OR_EQUIVALENCE|The immune seroresponse to pertussis toxin (PT), when DTaP is given concomitantly with MenACWY-CRM, was considered non-inferior to that of DTaP given alone, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than or equal to -10%.|Group difference|-4.0|||||TWO_SIDED|95.0|-12.1|4.3|||Miettinen and Nurminen|||To demonstrate the non-inferiority of seroresponse to pertussis toxin (PT), when DTaP vaccine is given, compared with MenACWY-CRM compared with when DTaP vaccine is given alone||4.3|-12.1|
72532695|NCT01000311|144594298|NON_INFERIORITY_OR_EQUIVALENCE|The immune seroresponse to pertussis (FHA antigen), when DTaP is given concomitantly with MenACWY-CRM, was considered non-inferior to that of DTaP given alone, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than or equal to -10%.|Group difference|4.0|||||TWO_SIDED|95.0|-5.1|13.6|||Miettinen and Nurminen|||To demonstrate the non-inferiority of seroresponse to pertussis FHA antigen, when DTaP vaccine is given with MenACWY-CRM compared with when DTaP vaccine is given alone||13.6|-5.1|
72532696|NCT01000311|144594298|NON_INFERIORITY_OR_EQUIVALENCE|The immune seroresponse to pertussis pertactin antigen, when DTaP vaccine is given concomitantly with MenACWY-CRM, was considered non-inferior to that of DTaP given alone, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than or equal to -10%.|Group difference|0.0|||||TWO_SIDED|95.0|-8.8|9.1|||Miettinen and Nurminen|||To demonstrate the non-inferiority of seroresponse to pertussis pertactin antigen, when DTaP vaccine is given with MenACWY-CRM compared with when DTaP is given alone.||9.1|-8.8|
72532697|NCT01000311|144594298|NON_INFERIORITY_OR_EQUIVALENCE|The immune seroresponse to pertussis FIM antigen, when DTaP is given concomitantly with MenACWY-CRM, was considered non-inferior to that of DTaP given alone, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than or equal to -10%.|Group difference|-2.0|||||TWO_SIDED|95.0|-10.6|6.8|||Miettinen and Nurminen|||To demonstrate the non-inferiority of seroresponse to pertussis FIM antigen, when DTaP vaccine is given with MenACWY-CRM compared with when DTaP vaccine is given alone||6.8|-10.6|
72532698|NCT01000311|144594298|NON_INFERIORITY_OR_EQUIVALENCE|The immune seroresponse to hepatitis B, when given concomitantly with MenACWY-CRM, was considered non-inferior to that of hepatitis B vaccine given alone, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than or equal to -10%.|Group difference|0.0|||||TWO_SIDED|95.0|-5.2|4.5|||Miettinen and Nurminen|||To demonstrate the non-inferiority of seroresponse to hepatitis B antigen, when hepatitis B vaccine is given with MenACWY-CRM compared with when hepatitis B vaccine is given alone.||4.5|-5.2|
72532699|NCT01000311|144594298|NON_INFERIORITY_OR_EQUIVALENCE|The immune seroresponse to Hib vaccine, when given concomitantly with MenACWY-CRM, was considered non-inferior to that of Hib vaccine given alone, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than or equal to -10%.|Group difference|5.0|||||TWO_SIDED|95.0|0.0|11.2|||Miettinen and Nurminen|||To demonstrate the non-inferiority of seroresponse to Hib antigen, when Hib vaccine is given with MenACWY-CRM compared with when Hib vaccine is given alone.||11.2|0|
72532700|NCT01000311|144594298|NON_INFERIORITY_OR_EQUIVALENCE|The immune seroresponse to polio antigen (Type 1), when IPV is given concomitantly with MenACWY-CRM, was considered non-inferior to that of IPV given alone, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than or equal to -5%.|Group difference|1.0|||||TWO_SIDED|95.0|-3.1|5.4|||Miettinen and Nurminen|||To demonstrate the non-inferiority of seroresponse to polio antigen (Type 1), when IPV routine is given with MenACWY-CRM, compared with when IPV is given alone||5.4|-3.1|
72532701|NCT01000311|144594298|NON_INFERIORITY_OR_EQUIVALENCE|The immune seroresponse to polio antigen (Type 2), when IPV is given concomitantly with MenACWY-CRM, was considered non-inferior to that of IPV given alone, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than or equal to -5%.|Group difference|1.0|||||TWO_SIDED|95.0|-1.4|3.0|||Miettinen and Nurminen|||To demonstrate the non-inferiority of seroresponse to polio antigen (Type 2), when IPV routine is given with MenACWY-CRM, compared with when IPV is given alone||3|-1.4|
72532702|NCT01000311|144594298|NON_INFERIORITY_OR_EQUIVALENCE|The immune seroresponse to polio antigen (Type 3), when IPV is given concomitantly with MenACWY-CRM, was considered non-inferior to that of IPV given alone, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than or equal to -5%.|Group difference|-1.0|||||TWO_SIDED|95.0|-3.3|1.7|||Miettinen and Nurminen|||To demonstrate the non-inferiority of seroresponse to polio antigen (Type 3), when IPV routine is given with MenACWY-CRM, compared with when IPV is given alone||1.7|-3.3|
72532703|NCT01000311|144594298|NON_INFERIORITY_OR_EQUIVALENCE|The immune seroresponse to pneumococcal PnC 4 antigen, when PCV is given concomitantly with MenACWY-CRM, was considered non-inferior to that of PCV given alone, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than or equal to -10%.|Group difference|1.0|||||TWO_SIDED|95.0|-1.9|4.6|||Miettinen and Nurminen|||To demonstrate the non-inferiority of seroresponse to pneumococcal PnC 4 antigen, when PCV is given with MenACWY-CRM, compared with when PCV is given alone||4.6|-1.9|
72532704|NCT01000311|144594298|NON_INFERIORITY_OR_EQUIVALENCE|The immune seroresponse to pneumococcal PnC 6B antigen, when PCV is given concomitantly with MenACWY-CRM, was considered non-inferior to that of PCV given alone, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than or equal to -10%.|Group difference|-4.0|||||TWO_SIDED|95.0|-10.3|3.2|||Miettinen and Nurminen|||To demonstrate the non-inferiority of seroresponse to pneumococcal PnC 6B antigen, when PCV is given with MenACWY-CRM, compared with when PCV is given alone||3.2|-10.3|
72532705|NCT01000311|144594298|NON_INFERIORITY_OR_EQUIVALENCE|The immune seroresponse to pneumococcal PnC 9V antigen, when PCV is given concomitantly with MenACWY-CRM, was considered non-inferior to that of PCV given alone, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than or equal to -10%.|Group difference|-3.0|||||TWO_SIDED|95.0|-8.7|2.3|||Miettinen and Nurminen|||To demonstrate the non-inferiority of seroresponse to pneumococcal PnC 9V antigen, when PCV is given with MenACWY-CRM, compared with when PCV is given alone||2.3|-8.7|
72532706|NCT01000311|144594298|NON_INFERIORITY_OR_EQUIVALENCE|The immune seroresponse to pneumococcal PnC 14 antigen, when PCV is given concomitantly with MenACWY-CRM, was considered non-inferior to that of PCV given alone, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than or equal to -10%.|Group difference|0.0|||||TWO_SIDED|95.0|-2.8|3.0|||Miettinen and Nurminen|||To demonstrate the non-inferiority of seroresponse to pneumococcal PnC 14 antigen, when PCV is given with MenACWY-CRM, compared with when PCV is given alone||3.0|-2.8|
72369211|NCT00611026|144248555|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Van Elteren's Test|P-value based on Van Elteren's Test (a stratified Wilcoxon-Mann Whitney test) adjusted by baseline quartile of voided volume.||Treatment difference fesoterodine vs placebo at Week 12. Treatment effects estimated by Winsorized means (5% of the tails were censored, ie, replaced with the value at the 5th and 95th percentile, respectively).||||<0.0001
72576775|NCT00261443|144680649|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.733||||0.384|TWO_SIDED|95.0|0.364|1.479||Stratified Log-rank Test P-value for Equality of Survival Curves|Stratified Log-rank Test||Cox proportional hazards model, with type of mood stabilizer and type of index mood episode as stratification factors, and treatment group as covariate.|||1.479|0.364|0.384
72532707|NCT01000311|144594298|NON_INFERIORITY_OR_EQUIVALENCE|The immune seroresponse to pneumococcal PnC 18C antigen, when PCV is given concomitantly with MenACWY-CRM, was considered non-inferior to that of PCV given alone, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than or equal to -10%.|Group difference|-3.0|||||TWO_SIDED|95.0|-7.3|1.6|||Miettinen and Nurminen|||To demonstrate the non-inferiority of seroresponse to pneumococcal PnC 18C antigen, when PCV is given with MenACWY-CRM, compared with when PCV is given alone||1.6|-7.3|
72532708|NCT01000311|144594298|NON_INFERIORITY_OR_EQUIVALENCE|The immune seroresponse to pneumococcal PnC 19F antigen, when PCV is given concomitantly with MenACWY-CRM, was considered non-inferior to that of PCV given alone, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than or equal to -10%.|Group difference|3.0|||||TWO_SIDED|95.0|1.3|7.1|||Miettinen and Nurminen|||To demonstrate the non-inferiority of seroresponse to pneumococcal PnC 19F antigen, when PCV is given with MenACWY-CRM, compared with when PCV is given alone||7.1|1.3|
72626239|NCT00402987|144781742|SUPERIORITY_OR_OTHER_LEGACY|||||||0.948||95.0||||"Analysis at 24 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.948
72626240|NCT00402987|144781743|SUPERIORITY_OR_OTHER_LEGACY|||||||0.775||95.0||||"Analysis at 15 min~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.775
72369212|NCT00611026|144248555|SUPERIORITY_OR_OTHER|||||||0.0021|TWO_SIDED||||||Van Elteren's Test|P-value based on Van Elteren's Test (a stratified Wilcoxon-Mann Whitney test) adjusted by baseline quartile of voided volume.||Treatment difference tolterodine ER vs placebo at Week 12. Treatment effects estimated by Winsorized means (5% of the tails were censored, ie, replaced with the value at the 5th and 95th percentile, respectively).||||0.0021
72532709|NCT01000311|144594298|NON_INFERIORITY_OR_EQUIVALENCE|The immune seroresponse to pneumococcal PnC 23F antigen, when PCV is given concomitantly with MenACWY-CRM, was considered non-inferior to that of PCV given alone, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than or equal to -10%.|Group difference|-5.0|||||TWO_SIDED|95.0|-11.4|0.5|||Miettinen and Nurminen|||To demonstrate the non-inferiority of seroresponse to pneumococcal PnC 23F antigen, when PCV is given with MenACWY-CRM, compared with when PCV is given alone||0.5|-11.4|
72532710|NCT01000311|144594299|NON_INFERIORITY_OR_EQUIVALENCE|The immune response measured as GMC of antibodies to pertussis toxin (PT), when DTaP is given concomitantly with MenACWY-CRM, was considered non-inferior to that of DTaP given alone, if the lower limit of the two-sided 95% CI for the ratio of GMCs (GMC of MenACWY-CRM + Routine Vaccines group divided by GMC of Routine Vaccines group) was greater than 0.67.|GMCs ratio|1.02|||||TWO_SIDED|95.0|0.81|1.28|||ANOVA|||To demonstrate the non-inferiority of GMC of antibodies to pertussis toxin (PT), when DTaP is given with MenACWY-CRM compared with when DTap is given alone||1.28|0.81|
72532711|NCT01000311|144594299|NON_INFERIORITY_OR_EQUIVALENCE|The immune response measured as GMC of antibodies to pertussis FHA antigen, when DTaP is given concomitantly with MenACWY-CRM, was considered non-inferior to that of DTaP given alone, if the lower limit of the two-sided 95% CI for the ratio of GMCs (GMC of MenACWY-CRM + Routine Vaccines group divided by GMC of Routine Vaccines group) was greater than 0.67.|GMCs ratio|1.04|||||TWO_SIDED|95.0|0.9|1.19|||ANOVA|||To demonstrate the non-inferiority of GMC of antibodies to pertussis FHA antigen, when DTaP is given with MenACWY-CRM compared with when DTaP is given alone||1.19|0.9|
72532712|NCT01000311|144594299|NON_INFERIORITY_OR_EQUIVALENCE|The immune response measured as GMC of antibodies to pertussis pertactin antigen, when DTaP is given concomitantly with MenACWY-CRM, was considered non-inferior to that of DTaP given alone, if the lower limit of the two-sided 95% CI for the ratio of GMCs (GMC of MenACWY-CRM + Routine Vaccines group divided by GMC of Routine Vaccines group) was greater than 0.67.|GMCs ratio|1.04|||||TWO_SIDED|95.0|0.84|1.28|||ANOVA|||To demonstrate the non-inferiority of GMC of antibodies to pertussis pertactin antigen, when DTaP is given with MenACWY-CRM compared with when DTaP is given alone||1.28|0.84|
72532713|NCT01000311|144594299|NON_INFERIORITY_OR_EQUIVALENCE|The immune response measured as GMC of antibodies to pertussis FIM antigen, when DTaP is given concomitantly with MenACWY-CRM, was considered non-inferior to that of DTaP given alone, if the lower limit of the two-sided 95% CI for the ratio of GMCs (GMC of MenACWY-CRM + Routine Vaccines group divided by GMC of Routine Vaccines group) was greater than 0.67.|GMCs ratio|1.09|||||TWO_SIDED|95.0|0.88|1.35|||ANOVA|||To demonstrate the non-inferiority of GMC of antibodies to pertussis FIM antigen, when DTaP is given with MenACWY-CRM compared with when DTaP is given alone||1.35|0.88|
72532714|NCT01000311|144594300|NON_INFERIORITY_OR_EQUIVALENCE|The immune response as GMC of antibodies to pneumococcal PnC 4 antigen, when PCV is given concomitantly with MenACWY-CRM, was considered non-inferior to that of PCV given alone, if the lower limit of the two-sided 95% CI for the ratio of GMCs (GMC of MenACWY-CRM + Prevnar group divided by GMC of Prevnar group) was greater than 0.50.|GMCs ratio|0.98|||||TWO_SIDED|95.0|0.8|1.19|||ANOVA|||To demonstrate the non-inferiority of GMC of antibodies to pneumococcal PnC 4 antigen when PCV is given with MenACWY-CRM compared with when PCV is given alone||1.19|0.8|
72532715|NCT01000311|144594300|NON_INFERIORITY_OR_EQUIVALENCE|The immune response as GMC of antibodies to pneumococcal PnC 6B antigen, when PCV is given concomitantly with MenACWY-CRM, was considered non-inferior to that of PCV given alone, if the lower limit of the two-sided 95% CI for the ratio of GMCs (GMC of MenACWY-CRM + Prevnar group divided by GMC of Prevnar group) was greater than 0.50.|GMCs ratio|0.76|||||TWO_SIDED|95.0|0.62|0.93|||ANOVA|||To demonstrate the non-inferiority of GMC of antibodies to pneumococcal PnC 6B antigen when PCV is given with MenACWY-CRM compared with when PCV is given alone||0.93|0.62|
72532716|NCT01000311|144594300|NON_INFERIORITY_OR_EQUIVALENCE|The immune response as GMC of antibodies to pneumococcal PnC 9V antigen, when PCV is given concomitantly with MenACWY-CRM, was considered non-inferior to that of PCV given alone, if the lower limit of the two-sided 95% CI for the ratio of GMCs (GMC of MenACWY-CRM + Prevnar group divided by GMC of Prevnar group) was greater than 0.50.|GMCs ratio|0.87|||||TWO_SIDED|95.0|0.72|1.06|||ANOVA|||To demonstrate the non-inferiority of GMC of antibodies to pneumococcal PnC 9V antigen when PCV is given with MenACWY-CRM compared with when PCV is given alone||1.06|0.72|
72626241|NCT00402987|144781743|SUPERIORITY_OR_OTHER_LEGACY|||||||0.094||95.0||||"Analysis at 30 min~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.094
72626242|NCT00402987|144781743|SUPERIORITY_OR_OTHER_LEGACY|||||||0.114||95.0||||"Analysis at 45 min~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.114
72532717|NCT01000311|144594300|NON_INFERIORITY_OR_EQUIVALENCE|The immune response as GMC of antibodies to pneumococcal PnC 14 antigen, when PCV is given concomitantly with MenACWY-CRM, was considered non-inferior to that of PCV given alone, if the lower limit of the two-sided 95% CI for the ratio of GMCs (GMC of MenACWY-CRM + Prevnar group divided by GMC of Prevnar group) was greater than 0.50.|GMCs ratio|1.04|||||TWO_SIDED|95.0|0.84|1.28|||ANOVA|||To demonstrate the non-inferiority of GMC of antibodies to pneumococcal PnC 14 antigen when PCV is given with MenACWY-CRM compared with when PCV is given alone||1.28|0.84|
72532718|NCT01000311|144594300|NON_INFERIORITY_OR_EQUIVALENCE|The immune response as GMC of antibodies to pneumococcal PnC 18C antigen, when PCV is given concomitantly with MenACWY-CRM, was considered non-inferior to that of PCV given alone, if the lower limit of the two-sided 95% CI for the ratio of GMCs (GMC of MenACWY-CRM + Prevnar group divided by GMC of Prevnar group) was greater than 0.50.|GMCs ratio|0.99|||||TWO_SIDED|95.0|0.82|1.2|||ANOVA|||To demonstrate the non-inferiority of GMC of antibodies to pneumococcal PnC 18C antigen when PCV is given with MenACWY-CRM compared with when PCV is given alone||1.2|0.82|
72532719|NCT01000311|144594300|NON_INFERIORITY_OR_EQUIVALENCE|The immune response as GMC of antibodies to pneumococcal PnC 19F antigen, when PCV is given concomitantly with MenACWY-CRM, was considered non-inferior to that of PCV given alone, if the lower limit of the two-sided 95% CI for the ratio of GMCs (GMC of MenACWY-CRM + Prevnar group divided by GMC of Prevnar group) was greater than 0.50.|GMCs ratio|0.89|||||TWO_SIDED|95.0|0.73|1.07|||ANOVA|||To demonstrate the non-inferiority of GMC of antibodies to pneumococcal PnC 19F antigen when PCV is given with MenACWY-CRM compared with when PCV is given alone||1.07|0.73|
72626243|NCT00402987|144781743|SUPERIORITY_OR_OTHER_LEGACY|||||||0.005||95.0||||"Analysis at 60 min~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.005
72532720|NCT01000311|144594300|NON_INFERIORITY_OR_EQUIVALENCE|The immune response as GMC of antibodies to pneumococcal PnC 23F antigen, when PCV is given concomitantly with MenACWY-CRM, was considered non-inferior to that of PCV given alone, if the lower limit of the two-sided 95% CI for the ratio of GMCs (GMC of MenACWY-CRM + Prevnar group divided by GMC of Prevnar group) was greater than 0.50.|GMCs ratio|0.84|||||TWO_SIDED|95.0|0.68|1.04|||ANOVA|||To demonstrate the non-inferiority of GMC of antibodies to pneumococcal PnC 23F antigen when PCV is given with MenACWY-CRM compared with when PCV is given alone||1.04|0.68|
72626244|NCT00402987|144781743|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 75 min~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
72532721|NCT02780869|144594306|NON_INFERIORITY|The primary endpoint was designed to establish comparable efficacy based upon a non-inferiority margin of 10% for the difference in the probability of TTH within 6 minutes comparing HEMOBLAST™ to G+T (HEMOBLAST™- G+T). Letting θ denote the true difference in the probability of hemostasis at 6 minutes between HEMOBLAST™ to G+T, the trial will test the null hypothesis H0: θ ≤ -0.10 vs. the alternative hypothesis HA : θ \> -0.10 using a one-sided level 0.025 test.|||||<|0.0001|||||||Cochran-Mantel-Haenszel|Stratified adjustments for surgery type were made using the Cochran-Mantel-Haenszel weighting.||||||<0.0001
72532722|NCT02780869|144594306|SUPERIORITY|||||||0.0001||||||Adjustment for mulitple comparisons were made when assessing secondary endpoints using a fixed sequence closed testing procedure to control the family-wise type I error rate at 0.05|Cochran-Mantel-Haenszel|||A secondary endpoint of superiority of HEMOBLAST relative to G+T for success at achieving hemostasis within 6 minutes was evaluated.||||0.0001
72532723|NCT02780869|144594307|SUPERIORITY||||||<|0.0001||||||Adjustment for mulitple comparisons were made when assessing secondary endpoints using a fixed sequence closed testing procedure to control the family-wise type I error rate at 0.05|Regression, Linear|||The difference in mean preparation time was tested using a linear regression model with stratified adjustment for surgery type.||||<0.0001
72532724|NCT02780869|144594308|NON_INFERIORITY|The difference in the probability of hemostasis within 3 minutes was tested using a logistic regression model with stratified adjustment for surgery type.|||||<|0.0001||||||Adjustment for multiple comparisons when assessing secondary endpoints was performed using a fixed sequence closed testing procedure to control the family-wise type I error rate at 0.05.|Regression, Logistic|||||||<0.0001
72532725|NCT02780869|144594308|SUPERIORITY|The difference in the probability of hemostasis within 3 minutes was tested using a logistic regression model with stratified adjustment for surgery type.||||||0.0001||||||Adjustment for multiple comparisons when assessing secondary endpoints was performed using a fixed sequence closed testing procedure to control the family-wise type I error rate at 0.05.|Regression, Logistic|||||||0.0001
72532726|NCT01377194|144594406|SUPERIORITY_OR_OTHER||Least squares mean difference|-3.303||||0.0027|TWO_SIDED|95.0|-5.457|-1.148|||mixed-model for repeated measures|||||-1.148|-5.457|0.0027
72532727|NCT01377194|144594406|SUPERIORITY_OR_OTHER||Least squares mean difference|-3.141||||0.0043|TWO_SIDED|95.0|-5.293|-0.988|||mixed-model for repeated measures|||||-0.988|-5.293|0.0043
72532728|NCT01377194|144594407|SUPERIORITY_OR_OTHER||Least squares mean difference|-1.827||||0.0459|TWO_SIDED|95.0|-3.62|-0.033|||Mixed Models Analysis|Mixed-effects model for repeated measures.||||-0.033|-3.620|0.0459
72626245|NCT00402987|144781743|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 90 min~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
72626246|NCT00402987|144781743|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 1.75 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
72626247|NCT00402987|144781743|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 2 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
72626248|NCT00402987|144781743|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 3 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
72626249|NCT00402987|144781743|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 4 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
72626250|NCT00402987|144781743|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 5 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
72626251|NCT00402987|144781743|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001||95.0||||"Analysis at 6 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.001
72626252|NCT00402987|144781744|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001||95.0||||"Analysis at 7 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.001
72626253|NCT00402987|144781744|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002||95.0||||"Analysis at 8 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.002
72626254|NCT00402987|144781744|SUPERIORITY_OR_OTHER_LEGACY|||||||0.007||95.0||||"Analysis at 9 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.007
72369213|NCT00611026|144248555|SUPERIORITY_OR_OTHER|||||||0.0525|TWO_SIDED||||||Van Elteren's Test|P-value based on Van Elteren's Test (a stratified Wilcoxon-Mann Whitney test) adjusted by baseline quartile of voided volume.||Treatment difference fesoterodine vs tolterodine ER at Week 12. Treatment effects estimated by Winsorized means (5% of the tails were censored, ie, replaced with the value at the 5th and 95th percentile, respectively).||||0.0525
72532729|NCT01377194|144594407|SUPERIORITY_OR_OTHER||Least squares mean difference|-2.72||||0.0028|TWO_SIDED|95.0|-4.494|-0.946|||Mixed Models Analysis|Mixed-effects model for repeated measures.||||-0.946|-4.494|0.0028
72532730|NCT00387621|144594408|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||t-test, 1 sided|With Bonferroni correction for multiple comparisons||||||<0.05
72532731|NCT00387621|144594409|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||rank-sum test|Rank-sum test was used due to non-normality of data with Bonferroni correction for multiple comparisons||||||<0.05
72532732|NCT02451137|144594418|SUPERIORITY||Odds Ratio (OR)|1.19||||0.0308|TWO_SIDED|95.4|1.01|1.39||Threshold for significance at 0.046 level.|Regression, Logistic|||A logistic regression model was used with treatment arm as a fixed effect and adjusted for: randomization strata of HbA1c target (\<8%,\<7%), sulfonylurea (SU) use (yes/no), glucagon like peptide1-receptor agonists (GLP-1 RA) use (yes/no) and baseline HbA1c (as continuous).||1.39|1.01|0.0308
72532733|NCT03747497|144594431|OTHER||Median Difference (Net)|-0.6|||||TWO_SIDED|95.0|-14.0|2.8||||||||2.8|-14.0|
72532734|NCT02545504|144594485|SUPERIORITY||Cox Proportional Hazard|0.93||||0.5625|TWO_SIDED|95.0|0.74|1.18||The significance level at final analysis is 0.046 (two-sided). Stratum with \< 6 participants or no informative event by combined treatment arms was pooled with the smallest adjacent stratum for stratified analyses.|Log Rank|p-value was stratified by Eastern Cooperative Oncology Group (ECOG) status, geographic region and primary tumor site.|Hazard ratio (HR) was stratified by ECOG status, geographic region and primary tumor site with treatment arm as the only covariate.|The primary and secondary endpoints were tested sequentially in the following gate-keeping order: the primary OS endpoint, then the secondary PFS endpoint, and finally the secondary ORR endpoint.||1.18|0.74|0.5625
72532735|NCT02545504|144594486|SUPERIORITY||Cox Proportional Hazard|0.84||||0.1031|TWO_SIDED|95.0|0.67|1.04||The significance level at final analysis was 0.032 (two-sided). Stratum with \< 6 participants or no informative event by combined treatment arms was pooled with the smallest adjacent stratum for stratified analyses.|Log Rank|p-value was stratified by ECOG status,geographic region and primary tumor site.|HR was stratified by ECOG status,geographic region;primary tumor site with treatment arm as a covariate.Stratum with \<6 participants or no informative event by combined treatment arms was pooled with smallest adjacent stratum for stratified analyses.|The primary and secondary endpoints were tested sequentially in the following gate-keeping order: the primary OS endpoint, then the secondary PFS endpoint, and finally the secondary ORR endpoint. PFS was tested only if OS was significant. The P-value is for display only.||1.04|0.67|0.1031
72532736|NCT02545504|144594487|SUPERIORITY||Odds Ratio (OR)|1.47||||0.0493|TWO_SIDED|95.0|1.0|2.15||The significance level at final analysis was 0.032 (two-sided). Stratum with \< 6 participants or no informative event by combined treatment arms was pooled with the smallest adjacent stratum for stratified analyses.|Cochran-Mantel-Haenszel|p-value was stratified by ECOG status, geographic region and primary tumor site.|OR was stratified by ECOG status, geographic region and primary tumor site. Stratum with \< 6 participants or no informative event by combined treatment arms was pooled with the smallest adjacent stratum for stratified analyses.|The primary and secondary endpoints were tested sequentially in the following gate-keeping order: the primary OS endpoint, then the secondary PFS endpoint, and finally the secondary ORR endpoint. ORR was tested only if OS and PFS were significant.The P-value is for display only.||2.15|1.00|0.0493
72532737|NCT02545504|144594487|SUPERIORITY||ORR Difference|9.4|||||TWO_SIDED|95.0|0.1|18.8|||||The 2-sided 95% confidence interval (CI) of difference for ORR between the treatment and placebo is calculated based on stratum-adjusted Cochran-Mantel-Haenszel proportion.|The primary and secondary endpoints were tested sequentially in the following gate-keeping order: the primary OS endpoint, then the secondary PFS endpoint, and finally the secondary ORR endpoint. ORR was tested only if OS and PFS were significant.||18.8|0.1|
72532738|NCT01266967|144594493|SUPERIORITY_OR_OTHER||percentage of participants|41.0|||<|0.0001|TWO_SIDED|95.0|29.3|52.6|||Exact Test||The estimated value represents the percentage of participants with OIR.|||52.6|29.3|<0.0001
72532739|NCT01266967|144594493|SUPERIORITY_OR_OTHER||percentage of participants|37.0|||<|0.0001|TWO_SIDED|95.0|25.3|49.8|||Exact Test||The estimated value represents the percentage of participants with OIR.|||49.8|25.3|<0.0001
72532740|NCT02713490|144594532|SUPERIORITY||LSMD|-26.884||||0.0381|TWO_SIDED|95.0|-56.608|2.841|||ANOVA|||||2.841|-56.608|0.0381
72626255|NCT00402987|144781744|SUPERIORITY_OR_OTHER_LEGACY|||||||0.015||95.0||||"Analysis at 10 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.015
72626256|NCT00402987|144781744|SUPERIORITY_OR_OTHER_LEGACY|||||||0.033||95.0||||"Analysis at 11 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.033
72626257|NCT00402987|144781744|SUPERIORITY_OR_OTHER_LEGACY|||||||0.036||95.0||||"Analysis at 12 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.036
72532741|NCT02713490|144594533|SUPERIORITY||LSM treatment ratio|0.203||||0.0029|TWO_SIDED|95.0|0.065|0.631|||ANOVA|||||0.631|0.065|0.0029
72532742|NCT02713490|144594534|SUPERIORITY||Treatment difference|0.098||||0.0088|TWO_SIDED|95.0|0.0284|0.1685|||Cochran-Mantel-Haenszel|||||0.1685|0.0284|0.0088
72532743|NCT02713490|144594535|SUPERIORITY|||||||0.023|||||||Log Rank|||Analysis applies to the overall distribution of time to first opioid rescue, estimated from Kaplan-Meier analysis.||||0.0230
72532744|NCT02713490|144594536|SUPERIORITY|||||||0.4285|||||||Kruskal-Wallis|||||||0.4285
72532745|NCT00346775|144594539|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2||||0.517|TWO_SIDED|95.0|-0.6|0.3|||ANCOVA|||||0.3|-0.6|0.517
72532746|NCT02138227|144594543|SUPERIORITY_OR_OTHER||||||<|0.01|||||||ANOVA|||||||<0.01
72532747|NCT02138227|144594544|SUPERIORITY_OR_OTHER||||||<|0.01|||||||ANOVA|F (2, 1574)||||||<0.01
72532748|NCT00960869|144594551|SUPERIORITY_OR_OTHER||proportions|2.7||||0.005|TWO_SIDED|95.0|1.1|5.5|||Cochran-Mantel-Haenszel|CMH test stratified by NSAID use=COX-2, other NSAID, or NSAID use=NO at randomization.|The proportion is from the PA32540 treatment group.|The primary efficacy endpoint was the proportion of subjects with gastric ulcers throughout 6 months of treatment. The primary endpoint was analyzed with the CMH test stratified by NSAID use (COX-2/Other NSAID/No) at randomization. A sample size of 250 subjects/treatment would provide 86% power to detect the difference of 8% between EC aspirin 325 mg (13%) and PA32540 (5%) with a 2-sided significance of 5%; and, provides adequate power to test the key secondary endpoints in sequential order.||5.5|1.1|0.005
72532749|NCT00960869|144594552|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|CMH test stratified by NSAID use=COX-2, other NSAID, or NSAID use=NO at randomization.||The cumulative proportion of subjects developing gastric ulcers and/or duodenal ulcers at 6 months was analyzed using the CMH test stratified by NSAID use=COX-2, other NSAID, or NSAID use=NO at randomization.||||<0.001
72532750|NCT00960869|144594553|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|CMH test stratified by NSAID use=COX-2, other NSAID, or NSAID use=NO at randomization.||The cumulative proportion of subjects with Treatment Success was analyzed using the CMH test stratified by NSAID use=COX-2, other NSAID, or NSAID use=NO at randomization.||||<0.001
72532751|NCT00960869|144594554|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|CMH test stratified by NSAID use=COX-2, other NSAID, or NSAID use=NO at randomization.||The cumulative proportion of subjects discontinuing from the study due to NSAID-associated upper GI adverse events was analyzed using the CMH test stratified by NSAID use=COX-2, other NSAID, or NSAID use=NO at randomization.||||<0.001
72532752|NCT00960869|144594555|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|CMH test stratified by NSAID use=COX-2, other NSAID, or NSAID use=NO and by baseline heartburn severity at randomization.||The proportion of subjects who had no heartburn at 6 months (regardless of the presence or absence of heartburn at baseline) was analyzed using the CMH test stratified by NSAID use=COX-2, other NSAID, or NSAID use=NO at randomization.||||<0.001
72532753|NCT01714726|144594558|SUPERIORITY||Risk Difference (RD)|22.5|||=|0.01|TWO_SIDED|90.0|8.3|36.8|||Regression, Logistic|||||36.8|8.3|=0.01
72532754|NCT02748096|144594591|OTHER||||||<|0.05||||||A p value of less than 0.05 was considered statistically significant for all the radiographic parameters .|t-test, 2 sided|This test applies to comparison between the two treatment arms and assesses all the radiographic parameters||The sample size was calculated from a previous study that used similar radiological assessments to compare OUKAs performed using conventional instrumentation and computer navigation. In this study, the standard deviation of the tibia varus/valgus angle for the control group was 3.6°. Assuming a minimum clinically important difference of 3°, the SMD would be 0.8. Hence with a power of 0.8 and significance level of 0.05, a total sample size of 44 patients (22 in each group) was required.||||<0.05
72532755|NCT02748096|144594592|OTHER||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
72532756|NCT02748096|144594593|OTHER||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
72532757|NCT01153971|144594608|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
72532758|NCT03410693|144594626|SUPERIORITY||ORR difference (R-C)|-2.1|||=|0.6991|TWO_SIDED|95.0|-14.0|9.9|||Fisher Exact|||||9.9|-14.0|=0.6991
72532759|NCT03410693|144594626|SUPERIORITY||ORR difference (R - C)|-4.5|||=|0.7944|TWO_SIDED|95.0|-18.9|9.9|||Fisher Exact|||||9.9|-18.9|=0.7944
72532760|NCT03410693|144594627|SUPERIORITY||DCR difference (R-C)|-5.1|||=|0.7962|TWO_SIDED|95.0|-19.9|9.7|||Fisher Exact|||||9.7|-19.9|=0.7962
72532761|NCT03410693|144594627|SUPERIORITY||DCR difference (R-C)|-10.3|||=|0.9109|TWO_SIDED|95.0|-27.5|6.9|||Fisher Exact|||||6.9|-27.5|=0.9109
72532762|NCT03410693|144594628|SUPERIORITY||Hazard Ratio (HR)|1.226|||=|0.8672|TWO_SIDED|95.0|0.853|1.762|||Log Rank|||||1.762|0.853|= 0.8672
72532763|NCT03410693|144594628|SUPERIORITY||Hazard Ratio (HR)|1.341||||0.9171|TWO_SIDED|95.0|0.88|2.043|||Log Rank|||||2.043|0.880|0.9171
72532764|NCT03628781|144594901|SUPERIORITY||Odds Ratio (OR)|0.384||||0.535|TWO_SIDED||||||Chi-squared|||||||.535
72532765|NCT03628781|144594902|SUPERIORITY||Slope|0.018|STANDARD_ERROR_OF_MEAN|0.081||0.829|TWO_SIDED||||||ANOVA|||||||.829
72532766|NCT03628781|144594903|SUPERIORITY||Slope|-0.105|STANDARD_ERROR_OF_MEAN|0.093||0.357|TWO_SIDED||||||ANOVA|||||||.357
72532767|NCT03628781|144594904|SUPERIORITY||Slope|-0.035|STANDARD_ERROR_OF_MEAN|0.126||0.782|TWO_SIDED||||||ANOVA|||||||.782
72532768|NCT01545375|144594915|SUPERIORITY|The objective was to demonstrate that VE induced by GSK2189242A vaccine (three doses in the first year of life and a booster dose in the second year of life)in preventing clinical AOM diagnosed and verified against AAP criteria was greater than 0%, as compared to the control group. One-sided p-value for the Wald-Test obtained from the general Cox proportional hazard model was calculated.|Vaccine Efficacy|3.81||||0.3016|TWO_SIDED|95.0|-11.35|16.9||The primary objective was met if the one-sided p-value calculated for the null hypothesis H0=\[clinical AOM VE ≤ 0%\] was lower than defined 1-sided alpha level: (17.8%).|Regression, Cox|||VE-AOM against AAP criteria: Occurrence of AOM during efficacy follow-up period was compared between groups to estimate Vaccine Efficacy (VE) and its 95% confidence interval using the Anderson \& Gill model (generalization of Cox proportional hazard model) taking into account for recurrent events \[Kelly, 2000\]. VE= (1 - hazard ratio) x 100 Censoring occurred at the time of the last scheduled or medically attended visit.||16.90|-11.35|0.3016
72532769|NCT02687815|144594940|SUPERIORITY||Hazard Ratio (HR)|1.13||||0.63|TWO_SIDED|95.0|0.69|1.85|||Regression, Cox|||||1.85|0.69|0.63
72532770|NCT02687815|144594941|SUPERIORITY||Hazard Ratio (HR)|1.32||||0.46|TWO_SIDED|95.0|0.63|2.75|||Regression, Cox|||||2.75|0.63|0.46
72532771|NCT02687815|144594942|SUPERIORITY||Odds Ratio (OR)|0.99||||0.99|TWO_SIDED|95.0|0.66|1.52|||Regression, Logistic|||||1.52|0.66|0.99
72532772|NCT02687815|144594943|SUPERIORITY||Mean Difference (Final Values)|4.4||||0.049|TWO_SIDED|95.0|0.001|8.8|||Regression, Linear|||||8.80|0.001|0.049
72532773|NCT06045026|144595013|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 4||||<0.0001
72532774|NCT06045026|144595013|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 8||||<0.0001
72532775|NCT06045026|144595013|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 12||||<0.0001
72532776|NCT06045026|144595013|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 16||||<0.0001
72532777|NCT06045026|144595013|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 20||||<0.0001
72532778|NCT06045026|144595013|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 24||||<0.0001
72532779|NCT06045026|144595014|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 4||||<0.0001
72532780|NCT06045026|144595014|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 8||||<0.0001
72532781|NCT06045026|144595014|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 12||||<0.0001
72532782|NCT06045026|144595014|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 16||||<0.0001
72532783|NCT06045026|144595014|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 20||||<0.0001
72532784|NCT06045026|144595014|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 24||||<0.0001
72532785|NCT06045026|144595015|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 4||||<0.0001
72532786|NCT06045026|144595015|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 8||||<0.0001
72532787|NCT06045026|144595015|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 12||||<0.0001
72532788|NCT06045026|144595015|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 16||||<0.0001
72532789|NCT06045026|144595015|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 20||||<0.0001
72532790|NCT06045026|144595015|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 24||||<0.0001
72532791|NCT06045026|144595016|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 4||||<0.0001
72532792|NCT06045026|144595016|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 8||||<0.0001
72532793|NCT06045026|144595016|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 12||||<0.0001
72532794|NCT06045026|144595016|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 16||||<0.0001
72532795|NCT06045026|144595016|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 20||||<0.0001
72532796|NCT06045026|144595016|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 24||||<0.0001
72532797|NCT06045026|144595017|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 4||||<0.0001
72532798|NCT06045026|144595017|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 8||||<0.0001
72532799|NCT06045026|144595017|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 12||||<0.0001
72532800|NCT06045026|144595017|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 16||||<0.0001
72532801|NCT06045026|144595017|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 20||||<0.0001
72532802|NCT06045026|144595017|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 24||||<0.0001
72532803|NCT06045026|144595018|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 4||||<0.0001
72532804|NCT06045026|144595018|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 8||||<0.0001
72532805|NCT06045026|144595018|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 12||||<0.0001
72532806|NCT06045026|144595018|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 16||||<0.0001
72532807|NCT06045026|144595018|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 20||||<0.0001
72532808|NCT06045026|144595018|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 24||||<0.0001
72532809|NCT06045026|144595019|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Q1 (How intense are the sensations?): Change from Baseline at Week 4||||<0.0001
72532810|NCT06045026|144595019|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Q1 (How intense are the sensations?): Change from Baseline at Week 8||||<0.0001
72532811|NCT06045026|144595019|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Q1 (How intense are the sensations?): Change from Baseline at Week 12||||<0.0001
72532812|NCT06045026|144595019|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Q1 (How intense are the sensations?): Change from Baseline at Week 16||||<0.0001
72532813|NCT06045026|144595019|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Q1 (How intense are the sensations?): Change from Baseline at Week 20||||<0.0001
72532814|NCT06045026|144595019|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Q1 (How intense are the sensations?): Change from Baseline at Week 24||||<0.0001
72532815|NCT06045026|144595019|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Q2 (How bothered are you by any sensations?): Change from Baseline at Week 4||||<0.0001
72532816|NCT06045026|144595019|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Q2 (How bothered are you by any sensations?): Change from Baseline at Week 8||||<0.0001
72532817|NCT06045026|144595019|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Q2 (How bothered are you by any sensations?): Change from Baseline at Week 12||||<0.0001
72626258|NCT00402987|144781744|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5||95.0||||"Analysis at 24 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.500
72532818|NCT06045026|144595019|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Q2 (How bothered are you by any sensations?): Change from Baseline at Week 16||||<0.0001
72532819|NCT06045026|144595019|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Q2 (How bothered are you by any sensations?): Change from Baseline at Week 20||||<0.0001
72532820|NCT06045026|144595019|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Q2 (How bothered are you by any sensations?): Change from Baseline at Week 24||||<0.0001
72532821|NCT06045026|144595019|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Q3 (How well can you tolerate sensations?): Change from Baseline at Week 4||||<0.0001
72532822|NCT06045026|144595019|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Q3 (How well can you tolerate sensations?): Change from Baseline at Week 8||||<0.0001
72532823|NCT06045026|144595019|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Q3 (How well can you tolerate sensations?): Change from Baseline at Week 12||||<0.0001
72532824|NCT06045026|144595019|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Q3 (How well can you tolerate sensations?): Change from Baseline at Week 16||||<0.0001
72532825|NCT06045026|144595019|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Q3 (How well can you tolerate sensations?): Change from Baseline at Week 20||||<0.0001
72532826|NCT06045026|144595019|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Q3 (How well can you tolerate sensations?): Change from Baseline at Week 24||||<0.0001
72532827|NCT06045026|144595020|SUPERIORITY|||||||0.01|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 4||||0.0100
72532828|NCT06045026|144595020|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 8||||<0.0001
72532829|NCT06045026|144595020|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 12||||<0.0001
72532830|NCT06045026|144595020|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 16||||<0.0001
72532831|NCT06045026|144595020|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 20||||<0.0001
72532832|NCT06045026|144595020|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 24||||<0.0001
72532833|NCT06045026|144595021|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 4||||<0.0001
72532834|NCT06045026|144595021|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 8||||<0.0001
72532835|NCT06045026|144595021|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 12||||<0.0001
72532836|NCT06045026|144595021|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 16||||<0.0001
72532837|NCT06045026|144595021|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 20||||<0.0001
72532838|NCT06045026|144595021|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 24||||<0.0001
72532839|NCT06045026|144595023|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 1||||<0.0001
72532840|NCT06045026|144595023|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 2||||<0.0001
72532841|NCT06045026|144595023|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 4||||<0.0001
72532842|NCT06045026|144595023|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 8||||<0.0001
72532843|NCT06045026|144595023|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 12||||<0.0001
72532844|NCT06045026|144595023|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 16||||<0.0001
72532845|NCT06045026|144595023|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 20||||<0.0001
72532846|NCT06045026|144595023|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 24||||<0.0001
72532847|NCT01399619|144595026|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||p-value corresponds to a two sided test against the historical rate of 40%.|normal approximation|||the SVR12 rate in total Faldaprevir group compared with the historical rate of 40%.||||<0.0001
72532848|NCT00399542|144595053|SUPERIORITY_OR_OTHER_LEGACY|||||||0.023||||||No adjustment|Cochran-Mantel-Haenszel|Stratified by pooled center, used to test the null hypothesis of equal rates between the 2 groups vs. the alternate hypothesis of non-equality||70.6% improvement in response with lubiprostone at 90% statistical power||||0.023
72532849|NCT00399542|144595054|SUPERIORITY_OR_OTHER_LEGACY|||||||0.391|||||||van Elteren nonparametric test|Adjusted for center||||||0.391
72532850|NCT00399542|144595055|SUPERIORITY_OR_OTHER_LEGACY|||||||0.151|||||||van Elteren nonparametric test|Adjusted for center||||||0.151
72532851|NCT00399542|144595056|SUPERIORITY_OR_OTHER_LEGACY|||||||0.163|||||||van Elteren nonparametric test|Adjusted for center||||||0.163
72532852|NCT00399542|144595057|SUPERIORITY_OR_OTHER_LEGACY|||||||0.185|||||||van Elteren nonparametric test|Adjusted for center||||||0.185
72532853|NCT00399542|144595058|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3|||||||Cochran-Mantel-Haenszel|||||||0.300
72532854|NCT00399542|144595059|SUPERIORITY_OR_OTHER_LEGACY|||||||0.303||||||Sequential closed testing procedures were employed|Cochran-Mantel-Haenszel|Stratified by pooled center, used to test the null hypothesis of equal rates between the 2 groups vs. the alternate hypothesis of non-equality||||||0.303
72532855|NCT00399542|144595060|SUPERIORITY_OR_OTHER_LEGACY|||||||0.047||||||Sequential closed testing procedures were employed|Cochran-Mantel-Haenszel|Stratified by pooled center, used to test the null hypothesis of equal rates between the 2 groups vs. the alternate hypothesis of non-equality||||||0.047
72532856|NCT00399542|144595061|SUPERIORITY_OR_OTHER_LEGACY|||||||0.008||||||Sequential closed testing procedures were employed|Cochran-Mantel-Haenszel|Stratified by pooled center, used to test the null hypothesis of equal rates between the 2 groups vs. the alternate hypothesis of non-equality||||||0.008
72532857|NCT00399542|144595062|SUPERIORITY_OR_OTHER_LEGACY|||||||0.663|||||||van Elteren nonparametric test|Adjusted for center||||||0.663
72532858|NCT00399542|144595063|SUPERIORITY_OR_OTHER_LEGACY|||||||0.224|||||||van Elteren nonparametric test|Adjusted for center||||||0.224
72408007|NCT03238911|144324424|SUPERIORITY||Mean Difference (Final Values)|15.55|||<|0.0001|TWO_SIDED|95.0|10.32|20.79|||Mixed model for repeated measures|||"Day 1~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||20.79|10.32|<0.0001
72532859|NCT00399542|144595064|SUPERIORITY_OR_OTHER_LEGACY|||||||0.271|||||||van Elteren nonparametric test|Adjusted for center||||||0.271
72532860|NCT00399542|144595065|SUPERIORITY_OR_OTHER_LEGACY|||||||0.945|||||||van Elteren nonparametric test|Adjusted for center||||||0.945
72532861|NCT00399542|144595066|SUPERIORITY_OR_OTHER_LEGACY|||||||0.352|||||||van Elteren nonparametric test|||||||0.352
72532862|NCT00399542|144595067|SUPERIORITY_OR_OTHER_LEGACY|||||||0.18|||||||van Elteren nonparametric test|Adjusted for center||||||0.180
72532863|NCT00399542|144595068|SUPERIORITY_OR_OTHER_LEGACY|||||||0.275|||||||van Elteren nonparametric test|Adjusted for center||||||0.275
72532864|NCT00399542|144595069|SUPERIORITY_OR_OTHER_LEGACY|||||||0.722|||||||van Elteren nonparametric test|Adjusted for center||||||0.722
72532865|NCT00399542|144595070|SUPERIORITY_OR_OTHER_LEGACY|||||||0.177|||||||van Elteren nonparametric test|Adjusted for center||||||0.177
72532866|NCT00399542|144595071|SUPERIORITY_OR_OTHER_LEGACY|||||||0.082|||||||van Elteren nonparametric test|Adjusted for center||||||0.082
72532867|NCT00399542|144595072|SUPERIORITY_OR_OTHER_LEGACY|||||||0.11|||||||van Elteren nonparametric test|Adjusted for center||||||0.110
72532868|NCT00399542|144595073|SUPERIORITY_OR_OTHER_LEGACY|||||||0.146|||||||van Elteren nonparametric test|Adjusted for center||||||0.146
72532869|NCT00399542|144595074|SUPERIORITY_OR_OTHER_LEGACY|||||||0.373|||||||van Elteren nonparametric test|Adjusted for center||||||0.373
72532870|NCT00399542|144595075|SUPERIORITY_OR_OTHER_LEGACY|||||||0.339|||||||van Elteren nonparametric test|Adjusted for center||||||0.339
72532871|NCT00399542|144595076|SUPERIORITY_OR_OTHER_LEGACY|||||||0.023|||||||Cochran-Mantel-Haenszel|||||||0.023
72532872|NCT00399542|144595077|SUPERIORITY_OR_OTHER_LEGACY|||||||0.073|||||||Cochran-Mantel-Haenszel|||||||0.073
72532873|NCT00399542|144595078|SUPERIORITY_OR_OTHER_LEGACY|||||||0.062|||||||ANCOVA|Adjusted for center||||||0.062
72532874|NCT00399542|144595079|SUPERIORITY_OR_OTHER_LEGACY|||||||0.06|||||||van Elteren nonparametric test|||||||0.060
72532875|NCT00399542|144595080|SUPERIORITY_OR_OTHER_LEGACY|||||||0.29|||||||van Elteren nonparametric test|||||||0.290
72532876|NCT00399542|144595081|SUPERIORITY_OR_OTHER_LEGACY|||||||0.495|||||||van Elteren nonparametric test|||||||0.495
72532877|NCT01830621|144595115|SUPERIORITY||Hazard Ratio (HR)|1.13||||0.337|TWO_SIDED|95.0|0.88|1.46|||Log Rank|||||1.46|0.88|0.337
72532878|NCT01830621|144595116|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.837|TWO_SIDED|95.0|0.76|1.26|||Log Rank|||||1.26|0.76|0.837
72532879|NCT01830621|144595117|SUPERIORITY||Odds Ratio (OR)|0.98||||0.955|TWO_SIDED|95.0|0.48|2.0|||Cochran-Mantel-Haenszel|||||2.00|0.48|0.955
72532880|NCT01830621|144595119|SUPERIORITY|||||||0.72|||||||Wilcoxon (Mann-Whitney)|||||||0.72
72532881|NCT00656669|144595143|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0001|||||||t-test, 2 sided|This is a paired t-test to compare baseline IFP to IFP after completion of sunitinib monotherapy||From Taghian et al., we used a mean IFP of 6.5 at baseline and a standard deviation of 6.1. We would like to detect a 50% reduction of IFP (to 3.25 mmHg) with sunitinib monotherapy, so the effect size would be 3.25/6.1=0.53. A two-sided paired t-test has 80% power to detect an effect size of .53 and level of significance .05 when the sample size is 30 patients.||||0.0001
72532882|NCT00656669|144595144|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7963||||||a priori threshold of \<0.05|t-test, 2 sided|This is a paired t-test to compare baseline IFP to IFP after completion of paxlitaxel+sunitinib treatment||||||0.7963
72532883|NCT03778021|144595147|SUPERIORITY||Mean Difference (Net)|0.22|STANDARD_ERROR_OF_MEAN|0.093||0.017|TWO_SIDED|95.0|0.04|0.41||"Estimated differential change in score between intervention and comparison group from repeated measures linear mixed model.~All the reported analyses conservatively specified covariance structure as general covariance (unstructured). alpha = 0.05."|Mixed Models Analysis|Repeated measures linear mixed model analysis. Student nested within school. Model fit time, intervention and time by intervention interaction.|Estimated differential change (intervention minus control) from repeated measures linear mixed model|"The unit of measure is score on a scale. The results show the least squares estimate of change in that score, from baseline to 8-month follow-up in each group from model.~Values from the 100 and 194 baseline respondents and from the 72 and 141 follow-up respondents of intervention and comparison groups respectively contributed to the repeated measures linear mixed model, where the units of analysis were participant-time. The nesting within schools was accounted for in the model."|"In the repeated measures linear mixed model, time was treated as a fixed effect. In the specification of the repeated measures linear mixed model, students were nested within schools.~All the reported analyses conservatively specified covariance structure as general covariance (unstructured)."|0.41|0.04|0.017
72532884|NCT03778021|144595148|SUPERIORITY||Mean Difference (Net)|1.41||||0.18|TWO_SIDED|95.0|-0.66|3.49||"Estimated differential change in score between intervention and comparison group from repeated measures linear mixed model.~All the reported analyses conservatively specified covariance structure as general covariance (unstructured). alpha = 0.05"|Mixed Models Analysis|Repeated measures linear mixed model analysis. Student nested within school. Model fit time, intervention and time by intervention interaction.|Estimated differential change from baseline to follow-up from model (intervention minus control)|"Results present estimated change in score from baseline to 8-month follow-up in each group from model.~Values from the 100 and 194 baseline respondents and from the 72 and 141 follow-up respondents of intervention and comparison groups respectively contributed to the repeated measures linear mixed model, where the units of analysis were participant-time. The nesting within schools was accounted for in the model."|In the repeated measures linear mixed model, time was treated as a fixed effect. In the specification of the repeated measures linear mixed model, students were nested within schools|3.49|-0.66|0.18
72572356|NCT02906930|144671988|SUPERIORITY|This hypothesis was controlled for multiplicity. Results are based on the data from the in-trial observation period. The estimated treatment effect includes the effect of any additional anti-diabetic medication for all randomised subjects regardless of premature trial product discontinuation (treatment policy estimand).|Mean treatment difference|-0.1||||0.8692|TWO_SIDED|95.0|-0.9|0.8||Unadjusted two-sided p-value for test of no difference from 0.|Pattern mixed model||Oral Semaglutide 3 mg - Placebo|The analysis was based on a pattern mixture model using multiple imputation to impute missing data for week 26, assuming that the missing data mechanism was missing at random within the groups used for the imputation. The imputed data sets were analysed using an ANCOVA model with treatment and region as categorical fixed effects and baseline body weight value as covariate for each of the 1000 imputed complete data sets, and pooled by Rubin's rule to draw inference.||0.8|-0.9|0.8692
72572357|NCT02906930|144671988|SUPERIORITY|This hypothesis was not controlled for multiplicity. Results are based on the data from the on-treatment without rescue medication observation period. The estimated treatment effect excludes the effect of any rescue medication (hypothetical estimand).|Mean treatment difference|-0.2||||0.7075|TWO_SIDED|95.0|-1.0|0.6|||MMRM||Oral Semaglutide 3 mg - Placebo|The analysis was based on a MMRM that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 26. The independent effects were treatment and region as categorical fixed effects and the baseline body weight value as a covariate, all nested within visit, and an unstructured residual covariance matrix.||0.6|-1.0|0.7075
72532885|NCT03778021|144595149|SUPERIORITY||Odds Ratio (OR)|1.29||||0.51|TWO_SIDED|95.0|0.6|2.81||"Repeated measures generalized linear mixed model with binomial distribution (variable was I know I can - yes versus no)."|Mixed Models Analysis|The odds of the odds ratio is reported as the intervention effect.|Odds ratio from estimated least squares from generalized mixed model with binomial distribution specified. Intervention odds of change compared to comparison group odds of change via odds ratio..|"Odds ratio of 8-month follow-up to baseline percent reporting  I know I can was estimated from repeated measures generalized linear mixed model with binomial distribution.~Values included from the 100 and 194 baseline respondents and from the 72 and 141 8-month follow-up respondents of intervention and comparison groups respectively. The person-timepoint is the unit of analysis."||2.81|0.60|0.51
72572358|NCT02906930|144671988|SUPERIORITY|This hypothesis was not controlled for multiplicity. Results are based on the data from the on-treatment without rescue medication observation period. The estimated treatment effect excludes the effect of any rescue medication (hypothetical estimand).|Mean treatment difference|-1.0||||0.0138|TWO_SIDED|95.0|-1.8|-0.2||Unadjusted two-sided p-value for test of no difference from 0.|MMRM||Oral Semaglutide 7 mg - Placebo|The analysis was based on a MMRM that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 26. The independent effects were treatment and region as categorical fixed effects and the baseline body weight value as a covariate, all nested within visit, and an unstructured residual covariance matrix.||-0.2|-1.8|0.0138
72576776|NCT00261443|144680651|SUPERIORITY_OR_OTHER_LEGACY||Difference|0.02||||0.955|TWO_SIDED|95.0|-0.73|0.77||Mean change from baseline: ANOVA model, controlling for treatment, mood stabilizer, index mood episode, and baseline value. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Baseline Comparison||0.77|-0.73|0.955
72532886|NCT01224171|144595155|SUPERIORITY_OR_OTHER||Risk Difference (RD)|3.0||||0.4332|TWO_SIDED|95.0|-4.5|10.5|||Cochran-Mantel-Haenszel||Risk Difference = adjusted (for stratification factors) percent vedolizumab - adjusted percent placebo|Clinical remission was tested using the Cochran-Mantel-Haenszel (CMH) chi-square test at a 5% significance level with stratification according to concomitant use of oral corticosteroids and concomitant use of immunomodulators (6-mercaptopurine \[6-MP\], azathioprine, or methotrexate) for the TNFα antagonist failure subpopulation.||10.5|-4.5|0.4332
72532887|NCT03737812|144595164|OTHER|a statistical test was not performed|Odds Ratio (OR)|2.23|||||TWO_SIDED|95.0|0.485|10.259||||||Analyzed using a logistic regression model with corresponding baseline value as a covariate and treatment as a main effect. Logistic regression model for EDSS+ includes baseline values for EDSS, Timed 25-Foot Walk, 9-Hole Peg Test-dominant, 9-Hole Peg Test-nondominant, and treatment as a main effect. Subjects with missing values were imputed as non-responders.||10.259|0.485|
72532888|NCT03737812|144595164|OTHER|a statistical test was not performed|Odds Ratio (OR)|3.859|||||TWO_SIDED|95.0|0.899|16.561||||||Analyzed using a logistic regression model with corresponding baseline value as a covariate and treatment as a main effect. Logistic regression model for EDSS+ includes baseline values for EDSS, Timed 25-Foot Walk, 9-Hole Peg Test-dominant, 9-Hole Peg Test-nondominant, and treatment as a main effect. Subjects with missing values were imputed as non-responders.||16.561|0.899|
72532889|NCT04140942|144595183|SUPERIORITY|||||||0.15|||||||Chi-squared|||6-Month Employment||||.15
72532890|NCT04140942|144595183|SUPERIORITY|||||||0.001|||||||Regression, Logistic|||6-Month Employment||||.001
72532891|NCT04140942|144595183|SUPERIORITY|||||||0.87|||||||Chi-squared|||12-Month Employment||||.87
72532892|NCT04140942|144595184|SUPERIORITY|||||||0.04|||||||ANCOVA|Repeated measures.||||||0.04
72532893|NCT04140942|144595185|SUPERIORITY|||||||0.056|||||||Chi-squared|||12-Month Recidivism Analysis||||.056
72532894|NCT04140942|144595185|SUPERIORITY|||||||0.18|||||||Chi-squared|||6-Month Recidivism Analysis||||.18
72532895|NCT00933543|144595222|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.43||||0.0703|TWO_SIDED|95.0|0.65|63.18||Priori threshold for statistical significance was 5%|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test stratified by center. No adjustment for multiple comparisons was done||H0: τ (Vehicle PDT) = τ (MAL PDT) versus HA: τ (Vehicle PDT) ≠ τ (MAL PDT)||63.18|0.65|0.0703
72532896|NCT00933543|144595224|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.92||||0.2969|TWO_SIDED|95.0|-11.35|3.5||Priori threshold for statistical significance was 5%|ANCOVA|ANCOVA model, including center and baseline lesion count as a covariates||H0: τ (Vehicle PDT) = τ (MAL PDT) versus HA: τ (Vehicle PDT) ≠ τ (MAL PDT)||3.50|-11.35|0.2969
72532897|NCT00933543|144595225|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.67||||0.8913|TWO_SIDED|95.0|-9.09|10.43||Priori threshold for statistical significance was 5%|ANCOVA|ANCOVA model, including center and baseline lesion count as a covariates||H0: τ (Vehicle PDT) = τ (MAL PDT) versus HA: τ (Vehicle PDT) ≠ τ (MAL PDT)||10.43|-9.09|0.8913
72532898|NCT04988035|144595248|SUPERIORITY||Odds Ratio (OR)|0.64||||0.09|TWO_SIDED|95.0|0.38|1.07|||Proportional odds model||Odds ratio greater than 1 favors Remdesivir plus Danicopan.|Includes all ordinal score categories. Odds ratio of a better clinical status score, confidence interval and p-value estimated from a proportional odds model adjusted for baseline steroid use and baseline ordinal score. Missing data imputed using multiple imputation (MI) for participants lost to follow-up before Day 8 while hospitalized, in hospice, long term acute care, or transferred to other hospital while those participants lost to follow-up after discharge to home are assigned a score of 2.||1.07|0.38|0.090
72532899|NCT04988035|144595249|SUPERIORITY||Odds Ratio (OR)|0.69||||0.358|TWO_SIDED|95.0|0.31|1.53|||Regression, Logistic|||Odds ratio, confidence interval, and p-value estimated from a logistic regression model adjusted for baseline dexamethasone use, baseline ordinal score, age, and baseline C-Reactive Protein (CRP).|Odds ratio greater than 1 favors Remdesivir plus Danicopan|1.53|0.31|0.358
72532900|NCT04988035|144595250|SUPERIORITY||Hazard Ratio (HR)|0.65||||0.014|TWO_SIDED|95.0|0.46|0.92|||Regression, Cox||HR greater than 1 favors Remdesivir plus Danicopan.|Hazard ratio, confidence interval, and p-value estimated from a Cox model adjusted for baseline steroid use and baseline ordinal score.||0.92|0.46|0.014
72532901|NCT04988035|144595251|SUPERIORITY||Odds Ratio (OR)|0.7||||0.177|TWO_SIDED|95.0|0.42|1.17|||Proportional odds model||Odds ratio above 1 favors Remdesivir plus Danicopan.|Includes all ordinal score categories. OR of a better clinical status score, confidence interval, and p-value estimated from a proportional odds model adjusted for baseline steroid use and baseline ordinal score. Missing data imputed using last observation carried forward for participants lost to follow-up before Day 15 while hospitalized, in hospice, long term acute care, or transferred to other hospital. Participants lost to follow-up before Day 15 after discharge are given a score of 2.||1.17|0.42|0.177
72532902|NCT04988035|144595252|SUPERIORITY||Odds Ratio (OR)|0.81||||0.427|TWO_SIDED|95.0|0.48|1.36|||Proportional odds model|||Includes all ordinal score categories. OR of a better clinical status score, confidence interval, and p-value estimated from a proportional odds model adjusted for baseline steroid use and baseline ordinal score. Missing data imputed using last observation carried forward for participants lost to follow-up before Day 29 while hospitalized, in hospice, long term acute care, or transferred to other hospital. Participants lost to follow-up before Day 29 after discharge are given a score of 2.|Odds ratio above 1 favors Remdesivir plus Danicopan.|1.36|0.48|0.427
72532903|NCT04988035|144595287|SUPERIORITY||Hazard Ratio (HR)|0.77||||0.109|TWO_SIDED|95.0|0.56|1.06|||Regression, Cox||HR greater than 1 favors Remdesivir plus Danicopan.|||1.06|0.56|0.109
72532904|NCT04988035|144595288|SUPERIORITY||Hazard Ratio (HR)|0.71||||0.036|TWO_SIDED|95.0|0.51|0.98|||Regression, Cox||||HR greater than 1 favors Remdesivir plus Danicopan.|0.98|0.51|0.036
72532905|NCT00612456|144595293|SUPERIORITY_OR_OTHER|Statistics has been presented for least square means using the LOCF dataset.|Mean Difference (Final Values)|5.83|STANDARD_ERROR_OF_MEAN|18.332||0.6241|TWO_SIDED|95.0|-31.05|42.71||If the estimates of change from baseline in CRLT were negative, then the one-sided p-values were the two-sided t-test of each treatment arm from this analysis divided by 2. If the estimates of change from baseline in CRLT were positive, then the one|ANCOVA|||Comparison between Baseline value and Day 29 value.||42.71|-31.05|0.6241
72532906|NCT00612456|144595293|SUPERIORITY_OR_OTHER|Statistics has been presented for least square means using the LOCF dataset.|Mean Difference (Final Values)|11.87|STANDARD_ERROR_OF_MEAN|19.081||0.7315|TWO_SIDED|95.0|-26.52|50.26||If the estimates of change from baseline in CRLT were negative, then the one-sided p-values were the two-sided t-test of each treatment arm from this analysis divided by 2. If the estimates of change from baseline in CRLT were positive, then the one|ANCOVA|||Comparison between Baseline value and Day 29 value.||50.26|-26.52|0.7315
72532907|NCT00612456|144595293|SUPERIORITY_OR_OTHER|Statistics has been presented for least square means using the OC dataset.|Mean Difference (Final Values)|5.76|STANDARD_ERROR_OF_MEAN|18.566||0.6212|TWO_SIDED|95.0|-31.65|43.18||If the estimates of change from baseline in CRLT were negative, then the one-sided p-values were the two-sided t-test of each treatment arm from this analysis divided by 2. If the estimates of change from baseline in CRLT were positive, then the one|ANCOVA|||Comparison between Baseline value and Day 29 value.||43.18|-31.65|0.6212
72532908|NCT00612456|144595293|SUPERIORITY_OR_OTHER|Statistics has been presented for least square means using the OC dataset.|Mean Difference (Final Values)|5.2|STANDARD_ERROR_OF_MEAN|20.662||0.5987|TWO_SIDED|95.0|-36.44|46.84||If the estimates of change from baseline in CRLT were negative, then the one-sided p-values were the two-sided t-test of each treatment arm from this analysis divided by 2. If the estimates of change from baseline in CRLT were positive, then the one|ANCOVA|||Comparison between Baseline value and Day 29 value.||46.84|-36.44|0.5987
72532909|NCT00612456|144595293|SUPERIORITY_OR_OTHER|Statistics has been presented for least square means.|Median Difference (Final Values)|-0.82|STANDARD_ERROR_OF_MEAN|18.114||0.482|TWO_SIDED|95.0|-37.28|35.64||If the estimates of change from baseline in CRLT were negative, then the one-sided p-values were the two-sided t-test of each treatment arm from this analysis divided by 2. If the estimates of change from baseline in CRLT were positive, then the one|ANCOVA|||LOCF Data excluding potential one outlier participant. Comparison between Baseline value and Day 29 value.||35.64|-37.28|0.4820
72532910|NCT00612456|144595293|SUPERIORITY_OR_OTHER|Statistics has been presented for least square means.|Mean Difference (Final Values)|19.9|STANDARD_ERROR_OF_MEAN|18.496||0.8562|TWO_SIDED|95.0|-17.33|57.13||If the estimates of change from baseline in CRLT were negative, then the one-sided p-values were the two-sided t-test of each treatment arm from this analysis divided by 2. If the estimates of change from baseline in CRLT were positive, then the one|ANCOVA|||LOCF Data excluding potential one outlier participant. Comparison between Baseline value and Day 29 value.||57.13|-17.33|0.8562
72532911|NCT00612456|144595293|SUPERIORITY_OR_OTHER|Statistics has been presented for least square means.|Mean Difference (Final Values)|-0.55|STANDARD_ERROR_OF_MEAN|18.3||0.488|TWO_SIDED|95.0|-37.46|36.35||If the estimates of change from baseline in CRLT were negative, then the one-sided p-values were the two-sided t-test of each treatment arm from this analysis divided by 2. If the estimates of change from baseline in CRLT were positive, then the one|ANCOVA|||OC Data excluding potential one outlier participant. Comparison between Baseline value and Day 29 value.||36.35|-37.46|0.4880
72626259|NCT00402987|144781745|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|16.2|||<|0.001||95.0|8.5|23.8||"Analysis at 2 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||23.8|8.5|<0.001
72532912|NCT00612456|144595293|SUPERIORITY_OR_OTHER|Statistics has been presented for least square means.|Mean Difference (Final Values)|13.97|STANDARD_ERROR_OF_MEAN|20.008||0.7556|TWO_SIDED|95.0|-26.38|54.32||If the estimates of change from baseline in CRLT were negative, then the one-sided p-values were the two-sided t-test of each treatment arm from this analysis divided by 2. If the estimates of change from baseline in CRLT were positive, then the one|ANCOVA|||OC Data excluding potential one outlier participant. Comparison between Baseline value and Day 29 value.||54.32|-26.38|0.7556
72532913|NCT00612456|144595300|SUPERIORITY_OR_OTHER|Statistics has been presented for least square means based on efficacy population.|Mean Difference (Final Values)|4.32|STANDARD_ERROR_OF_MEAN|1.29||0.0015|TWO_SIDED|95.0|1.74|6.91|||ANCOVA|||Comparison between Baseline value and Day 29 value.||6.91|1.74|0.0015
72532914|NCT00612456|144595300|SUPERIORITY_OR_OTHER|Statistics has been presented for least square means based on efficacy population.|Mean Difference (Final Values)|0.76|STANDARD_ERROR_OF_MEAN|1.403||0.5921|TWO_SIDED|95.0|-2.05|3.57|||ANCOVA|||Comparison between Baseline value and Day 29 value.||3.57|-2.05|0.5921
72532915|NCT00612456|144595300|SUPERIORITY_OR_OTHER|Statistics has been presented for least square means based on efficacy population.|Mean Difference (Final Values)|0.09|STANDARD_ERROR_OF_MEAN|1.988||0.9646|TWO_SIDED|95.0|-3.89|4.07|||ANCOVA|||Comparison between Baseline value and Day 29 value.||4.07|-3.89|0.9646
72532916|NCT00612456|144595300|SUPERIORITY_OR_OTHER|Statistics has been presented for least square means based on participants with a 'YES' for RCA NONE field from DARC FA form in study eye at screening.|Mean Difference (Final Values)|4.75||||0.0003|TWO_SIDED|95.0|2.32|7.19|||ANCOVA|||Comparison between Baseline value and Day 29 value.||7.19|2.32|0.0003
72532917|NCT00612456|144595300|SUPERIORITY_OR_OTHER|Statistics has been presented for least square means based on participants with a 'YES' for RCA NONE field from DARC FA form in study eye at screening.|Mean Difference (Final Values)|1.64|STANDARD_ERROR_OF_MEAN|1.326||0.2208|TWO_SIDED|95.0|-1.02|4.3|||ANCOVA|||Comparison between Baseline value and Day 29 value.||4.30|-1.02|0.2208
72532918|NCT00612456|144595300|SUPERIORITY_OR_OTHER|Statistics has been presented for least square means based on participants with a 'YES' for RCA NONE field from DARC FA form in study eye at screening.|Mean Difference (Final Values)|-0.04|STANDARD_ERROR_OF_MEAN|1.927||0.9847|TWO_SIDED|95.0|-3.9|3.83|||ANCOVA|||Comparison between Baseline value and Day 29 value.||3.83|-3.90|0.9847
72532919|NCT00612456|144595300|SUPERIORITY_OR_OTHER|Statistics has been presented for least square means based on participants with a 'YES' for eligible field from DARC FA form in study eye at screening.|Mean Difference (Final Values)|3.53|STANDARD_ERROR_OF_MEAN|1.376||0.0142|TWO_SIDED|95.0|0.75|6.31|||ANCOVA|||Comparison between Baseline value and Day 29 value.||6.31|0.75|0.0142
72532920|NCT00612456|144595300|SUPERIORITY_OR_OTHER|Statistics has been presented for least square means based on participants with a 'YES' for eligible field from DARC FA form in study eye at screening.|Mean Difference (Final Values)|0.85|STANDARD_ERROR_OF_MEAN|1.419||0.5547|TWO_SIDED|95.0|-2.02|3.71|||ANCOVA|||Comparison between Baseline value and Day 29 value.||3.71|-2.02|0.5547
72532921|NCT00612456|144595300|SUPERIORITY_OR_OTHER|Statistics has been presented for least square means based on participants with a 'YES' for eligible field from DARC FA form in study eye at screening.|Mean Difference (Final Values)|0.26|STANDARD_ERROR_OF_MEAN|2.287||0.9114|TWO_SIDED|95.0|-4.37|4.88|||ANCOVA|||Comparison between Baseline value and Day 29 value.||4.88|-4.37|0.9114
72532922|NCT00612456|144595303|SUPERIORITY_OR_OTHER|Statistics has been presented for least square means.|Mean Difference (Final Values)|0.76|STANDARD_ERROR_OF_MEAN|0.383||0.0534|TWO_SIDED|95.0|-0.01|1.53|||ANCOVA|||Comparison between Baseline value and Day 29 value for FA Leakage Area of measurement.||1.53|-0.01|0.0534
72532923|NCT00612456|144595303|SUPERIORITY_OR_OTHER|Statistics has been presented for least square means.|Mean Difference (Final Values)|0.82|STANDARD_ERROR_OF_MEAN|0.409||0.0508|TWO_SIDED|95.0|0.0|1.64|||ANCOVA|||Comparison between Baseline value and Day 29 value for FA Leakage Area of measurement.||1.64|-0.00|0.0508
72532924|NCT00612456|144595303|SUPERIORITY_OR_OTHER|Statistics has been presented for least square means.|Mean Difference (Final Values)|0.61||||0.3141|TWO_SIDED|95.0|-0.6|1.83|||ANCOVA|||Comparison between Baseline value and Day 29 value for FA Leakage Area of measurement.||1.83|-0.60|0.3141
72532925|NCT00612456|144595303|SUPERIORITY_OR_OTHER|Statistics has been presented for least square means.|Mean Difference (Final Values)|-0.21|STANDARD_ERROR_OF_MEAN|0.395||0.6018|TWO_SIDED|95.0|-1.04|0.62|||ANCOVA|||Comparison between Baseline value and Day 29 value for FA Blood Area of measurement.||0.62|-1.04|0.6018
72532926|NCT00612456|144595303|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.0|STANDARD_ERROR_OF_MEAN|0.476||0.0509|TWO_SIDED|95.0|0.0|2.0||Statistics has been presented for least square means.|ANCOVA|||Comparison between Baseline value and Day 29 value for FA Blood Area of measurement.||2.00|-0.00|0.0509
72532927|NCT00612456|144595303|SUPERIORITY_OR_OTHER|Statistics has been presented for least square means.|Mean Difference (Final Values)|0.49|STANDARD_ERROR_OF_MEAN|0.566||0.3976|TWO_SIDED|95.0|-0.7|1.68|||ANCOVA|||Comparison between Baseline value and Day 29 value for FA Blood Area of measurement.||1.68|-0.70|0.3976
72532928|NCT00612456|144595303|SUPERIORITY_OR_OTHER|Statistics has been presented for least square means.|Mean Difference (Final Values)|0.46|STANDARD_ERROR_OF_MEAN|0.385||0.241|TWO_SIDED|95.0|-0.32|1.23|||ANCOVA|||Comparison between Baseline value and Day 29 value for Total Lesion size||1.23|-0.32|0.2410
72532929|NCT00612456|144595303|SUPERIORITY_OR_OTHER|Statistics has been presented for least square means.|Mean Difference (Final Values)|1.27|STANDARD_ERROR_OF_MEAN|0.412||0.0032|TWO_SIDED|95.0|0.44|2.09|||ANCOVA|||Comparison between Baseline value and Day 29 value for Total Lesion size||2.09|0.44|0.0032
72532930|NCT00612456|144595303|SUPERIORITY_OR_OTHER|Statistics has been presented for least square means.|Mean Difference (Final Values)|0.58|STANDARD_ERROR_OF_MEAN|0.581||0.3185|TWO_SIDED|95.0|-0.58|1.75|||ANCOVA|||Comparison between Baseline value and Day 29 value for Total Lesion size||1.75|-0.58|0.3185
72532931|NCT00612456|144595303|SUPERIORITY_OR_OTHER|Statistics has been presented for least square means.|Mean Difference (Final Values)|0.62|STANDARD_ERROR_OF_MEAN|0.377||0.1074|TWO_SIDED|95.0|-0.14|1.37|||ANCOVA|||Comparison between Baseline value and Day 29 value for CNV Size||1.37|-0.14|0.1074
72532932|NCT00612456|144595303|SUPERIORITY_OR_OTHER|Statistics has been presented for least square means.|Mean Difference (Final Values)|0.85|STANDARD_ERROR_OF_MEAN|0.402||0.0403|TWO_SIDED|95.0|0.04|1.65|||ANCOVA|||Comparison between Baseline value and Day 29 value for CNV Size||1.65|0.04|0.0403
72532933|NCT00612456|144595303|SUPERIORITY_OR_OTHER|Statistics has been presented for least square means.|Mean Difference (Final Values)|0.69|STANDARD_ERROR_OF_MEAN|0.594||0.249|TWO_SIDED|95.0|-0.5|1.88|||ANCOVA|||Comparison between Baseline value and Day 29 value for CNV Size||1.88|-0.50|0.2490
72532934|NCT01258803|144595307|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.124|||<|0.001|TWO_SIDED|95.0|0.094|0.154|||ANCOVA|||"Pairwise Treatment Comparison of MF/F MDI with spacer and Placebo MDI combined with or without spacer.~Analysis was performed using an analysis of covariance (ANCOVA) model extracting the effects due to treatment, sequence, subject (random effect nested within sequence), period, age groups (5 to 7 years and 8 to 11 years) and Baseline FEV1 as a covariate."||0.154|0.094|<0.001
72532935|NCT01258803|144595308|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.102|||<|0.001|TWO_SIDED|95.0|0.073|0.131|||ANCOVA|||"Pairwise Treatment Comparison of MF/F MDI without spacer and Placebo MDI combined with or without spacer.~Analysis was performed using an ANCOVA model extracting the effects due to treatment, sequence, subject (random effect nested within sequence), period, age groups (5 to 7 years and 8 to 11 years) and Baseline FEV1 as a covariate."||0.131|0.073|<0.001
72532936|NCT01258803|144595309|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.022||||0.144|TWO_SIDED|95.0|-0.008|0.052|||ANCOVA|||"Pairwise Treatment Comparison of MF/F MDI with spacer and MF/F MDI without spacer.~Analysis was performed using an ANCOVA model extracting the effects due to treatment, sequence, subject (random effect nested within sequence), period, age groups (5 to 7 years and 8 to 11 years) and Baseline FEV1 as a covariate."||0.052|-0.008|0.144
72532937|NCT01258803|144595311|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.018||||0.229|TWO_SIDED|95.0|-0.012|0.048|||ANCOVA|||"Pairwise Treatment Comparison of MF/F MDI with spacer and F DPI.~Analysis was performed using an ANCOVA model extracting the effects due to treatment, sequence, subject (random effect nested within sequence), period, age groups (5 to 7 years and 8 to 11 years) and Baseline FEV1 as a covariate."||0.048|-0.012|0.229
72532938|NCT01258803|144595312|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.004||||0.79|TWO_SIDED|95.0|-0.033|0.025|||ANCOVA|||"Pairwise Treatment Comparison of MF/F MDI without spacer and F DPI.~Analysis was performed using an ANCOVA model extracting the effects due to treatment, sequence, subject (random effect nested within sequence), period, age groups (5 to 7 years and 8 to 11 years) and Baseline FEV1 as a covariate."||0.025|-0.033|0.790
72532939|NCT01258803|144595313|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.106|||<|0.001|TWO_SIDED|95.0|0.077|0.135|||ANCOVA|||"Pairwise Treatment Comparison of F DPI and Placebo MDI combined with or without spacer.~Analysis was performed using an ANCOVA model extracting the effects due to treatment, sequence, subject (random effect nested within sequence), period, age groups (5 to 7 years and 8 to 11 years) and Baseline FEV1 as a covariate."||0.135|0.077|<0.001
72532940|NCT00920582|144595315|SUPERIORITY||Odds Ratio (OR)|1.348||||0.609|TWO_SIDED|95.0|0.431|4.219|||Mantel Haenszel|||||4.219|0.431|0.609
72532941|NCT00920582|144595315|SUPERIORITY||Odds Ratio (OR)|1.356||||0.601|TWO_SIDED|95.0|0.453|4.23|||Mantel Haenszel|||||4.230|0.453|0.601
72532942|NCT00920582|144595315|SUPERIORITY||Odds Ratio (OR)|1.624||||0.4|TWO_SIDED|95.0|0.521|5.066|||Mantel Haenszel|||||5.066|0.521|0.400
72532943|NCT00920582|144595317|SUPERIORITY||Mean Difference (Final Values)|-0.028||||0.365|TWO_SIDED|95.0|-0.086|0.031|||ANCOVA|||||0.031|-0.086|0.365
72532944|NCT00920582|144595317|SUPERIORITY||Mean Difference (Final Values)|-0.007||||0.842|TWO_SIDED|95.0|-0.078|0.064|||ANCOVA|||||0.064|-0.078|0.842
72532945|NCT00920582|144595317|SUPERIORITY||Mean Difference (Final Values)|0.021||||0.565|TWO_SIDED|95.0|-0.089|0.171|||ANCOVA|||||0.171|-0.089|0.565
72532946|NCT00920582|144595322|SUPERIORITY||Odds Ratio (OR)|2.197||||0.142|TWO_SIDED|95.0|0.764|6.312|||Mantel Haenszel|||||6.312|0.764|0.142
72532947|NCT00920582|144595322|SUPERIORITY||Odds Ratio (OR)|1.487||||0.46|TWO_SIDED|95.0|0.517|4.278|||Mantel Haenszel|||||4.278|0.517|0.460
72532948|NCT00920582|144595322|SUPERIORITY||Odds Ratio (OR)|1.954||||0.199|TWO_SIDED|95.0|0.69|5.532|||Mantel Haenszel|||||5.532|0.690|0.199
72532949|NCT04652245|144595333|SUPERIORITY|||||||0.028|||||||ANCOVA|||||||0.028
72532950|NCT04652245|144595334|SUPERIORITY|||||||0.008|||||||ANCOVA|||||||0.008
72532951|NCT04419558|144595338|OTHER||LS Mean Difference|0.03|STANDARD_ERROR_OF_MEAN|0.077||0.6579|TWO_SIDED|95.0|-0.12|0.19|||Mixed Models Analysis|||||0.19|-0.12|0.6579
72532952|NCT05146999|144595350|SUPERIORITY||Treatment difference|83.8|||<|0.001|TWO_SIDED|95.0|72.81|94.87|||Cochran-Mantel-Haenszel|||||94.87|72.81|<0.001
72532953|NCT00796367|144595391|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.71|STANDARD_ERROR_OF_MEAN|0.673|<|0.0001|TWO_SIDED|95.0|7.39|10.03||Intersection-union method applied in a step-down testing approach|ANCOVA|||No formal calculation of sample size was conducted due to being an extension study of OB-303 (NCT00553787)||10.03|7.39|<0.0001
72532954|NCT00796367|144595391|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.52|STANDARD_ERROR_OF_MEAN|0.799|<|0.0001|TWO_SIDED|95.0|5.95|9.09||Intersection-union method applied in a step-down testing approach|ANCOVA|||No formal calculation of sample size was conducted due to being an extension study of OB-303 (NCT00553787)||9.09|5.95|<0.0001
72532955|NCT00796367|144595391|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.19|STANDARD_ERROR_OF_MEAN|0.76||0.1189|TWO_SIDED|95.0|-0.31|2.68||Intersection-union method applied in a step-down testing approach|ANCOVA|||No formal calculation of sample size was conducted due to being an extension study of OB-303 (NCT00553787)||2.68|-0.31|0.1189
72532956|NCT00796367|144595392|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|9.4|STANDARD_ERROR_OF_MEAN|1.97|<|0.0001|TWO_SIDED|95.0|6.24|14.16||Intersection-union method applied in a step-down testing approach|Regression, Logistic|||No formal calculation of sample size was conducted due to being an extension study of OB-303 (NCT00553787)||14.16|6.24|<0.0001
72532957|NCT00796367|144595392|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.99|STANDARD_ERROR_OF_MEAN|1.68|<|0.0001|TWO_SIDED|95.0|4.36|11.19||Intersection-union method applied in a step-down testing approach|Regression, Logistic|||No formal calculation of sample size was conducted due to being an extension study of OB-303 (NCT00553787)||11.19|4.36|<0.0001
72532958|NCT00796367|144595392|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.35|STANDARD_ERROR_OF_MEAN|0.32||0.2169|TWO_SIDED|95.0|0.84|2.15|||Regression, Logistic|||No formal calculation of sample size was conducted due to being an extension study of OB-303 (NCT00553787)||2.15|0.84|0.2169
72626260|NCT00402987|144781745|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|10.2||||0.009||95.0|2.6|17.9||"Analysis at 2 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||17.9|2.6|0.009
72532959|NCT05664672|144595393|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|24.2|||<|0.0001|TWO_SIDED|95.0|15.9|37.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||37.0|15.9|<.0001
72532960|NCT05664672|144595393|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|25.3|||<|0.0001|TWO_SIDED|95.0|17.1|37.3|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||37.3|17.1|<.0001
72532961|NCT05664672|144595393|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|22.4|||<|0.0001|TWO_SIDED|95.0|14.9|33.7|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||33.7|14.9|<.0001
72532962|NCT05664672|144595393|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|16.5|||<|0.0001|TWO_SIDED|95.0|10.8|25.3|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||25.3|10.8|<.0001
72532963|NCT05664672|144595393|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|147.0||||0.1148|TWO_SIDED|95.0|93.7|230.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||230|93.7|0.1148
72532964|NCT05664672|144595393|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|153.0||||0.044|TWO_SIDED|95.0|101.0|233.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||233|101|0.0440
72532965|NCT05664672|144595393|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|136.0||||0.2422|TWO_SIDED|95.0|87.8|210.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||210|87.8|0.2422
72532966|NCT05664672|144595394|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|49.9||||0.0994|TWO_SIDED|95.0|22.7|110.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||110|22.7|0.0994
72532967|NCT05664672|144595394|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|65.8||||0.4162|TWO_SIDED|95.0|32.0|135.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||135|32.0|0.4162
72532968|NCT05664672|144595394|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|101.0||||1|TWO_SIDED|95.0|47.5|215.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||215|47.5|1.0000
72532969|NCT05664672|144595394|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|2.23|||<|0.0001|TWO_SIDED|95.0|1.01|4.94|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||4.94|1.01|<.0001
72532970|NCT05664672|144595394|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|2230.0|||<|0.0001|TWO_SIDED|95.0|965.0|5160.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||5160|965|<.0001
72532971|NCT05664672|144595394|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|2940.0|||<|0.0001|TWO_SIDED|95.0|1350.0|6400.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||6400|1350|<.0001
72576777|NCT00261443|144680651|SUPERIORITY_OR_OTHER_LEGACY||Difference|0.06||||0.895|TWO_SIDED|95.0|-0.83|0.95||Mean change from baseline: ANOVA model, controlling for treatment, mood stabilizer, index mood episode, and baseline value. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 4 Comparison||0.95|-0.83|0.895
72532972|NCT05664672|144595394|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|4530.0|||<|0.0001|TWO_SIDED|95.0|2020.0|10200.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||10200|2020|<.0001
72532973|NCT05664672|144595395|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|5.69|||<|0.0001|TWO_SIDED|95.0|3.29|9.87|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||9.87|3.29|<.0001
72532974|NCT05664672|144595395|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|8.08|||<|0.0001|TWO_SIDED|95.0|4.88|13.4|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||13.4|4.88|<.0001
72532975|NCT05664672|144595395|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|6.58|||<|0.0001|TWO_SIDED|95.0|3.88|11.2|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||11.2|3.88|<.0001
72532976|NCT05664672|144595395|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|6.03|||<|0.0001|TWO_SIDED|95.0|3.46|10.5|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||10.5|3.46|<.0001
72532977|NCT05664672|144595395|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|94.4||||0.9972|TWO_SIDED|95.0|52.7|169.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||169|52.7|0.9972
72532978|NCT05664672|144595395|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|134.0||||0.4655|TWO_SIDED|95.0|77.9|230.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||230|77.9|0.4655
72572359|NCT02906930|144671988|SUPERIORITY|This hypothesis was not controlled for multiplicity. Results are based on the data from the on-treatment without rescue medication observation period. The estimated treatment effect excludes the effect of any rescue medication (hypothetical estimand).|Mean treatment difference|-2.6|||<|0.0001|TWO_SIDED|95.0|-3.4|-1.8||Unadjusted two-sided p-value for test of no difference from 0.|MMRM||Oral Semaglutide 14 mg - Placebo|The analysis was based on a MMRM that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 26. The independent effects were treatment and region as categorical fixed effects and the baseline body weight value as a covariate, all nested within visit, and an unstructured residual covariance matrix.||-1.8|-3.4|<0.0001
72572360|NCT02906930|144672011|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|0.45||||0.0043|TWO_SIDED|95.0|0.26|0.78||Unadjusted two-sided p-value for test of no difference from 1|Regression, Cox||Oral Semaglutide 3 mg / Placebo|Time to initiation of additional anti-diabetic medication was analysed using a Cox proportional hazards model with treatment and region as categorical fixed effects and baseline HbA1c as covariate. Withdrawal for any reason or lost to follow-up contributed to the analysis as events (initiation of additional anti-diabetic medication). Censoring time was one day before planned end of treatment.||0.78|0.26|0.0043
72572361|NCT02906930|144672011|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|0.33||||0.0002|TWO_SIDED|95.0|0.18|0.59||Unadjusted two-sided p-value for test of no difference from 1|Regression, Cox||Oral Semaglutide 7 mg / Placebo|Time to initiation of additional anti-diabetic medication was analysed using a Cox proportional hazards model with treatment and region as categorical fixed effects and baseline HbA1c as covariate. Withdrawal for any reason or lost to follow-up contributed to the analysis as events (initiation of additional anti-diabetic medication). Censoring time was one day before planned end of treatment.||0.59|0.18|0.0002
72572362|NCT02906930|144672011|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|0.33||||0.0002|TWO_SIDED|95.0|0.19|0.6||Unadjusted two-sided p-value for test of no difference from 1|Regression, Cox||Oral Semaglutide 14 mg / Placebo|Time to initiation of additional anti-diabetic medication was analysed using a Cox proportional hazards model with treatment and region as categorical fixed effects and baseline HbA1c as covariate. Withdrawal for any reason or lost to follow-up contributed to the analysis as events (initiation of additional anti-diabetic medication). Censoring time was one day before planned end of treatment.||0.60|0.19|0.0002
72572363|NCT02906930|144672012|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|0.48||||0.03|TWO_SIDED|95.0|0.25|0.93||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox||Oral Semaglutide 3 mg / Placebo|Time to initiation of rescue medication was analysed using a Cox proportional hazards model with treatment and region as categorical fixed effects and baseline HbA1c as covariate. Censoring time was one day before last day on trial product.||0.93|0.25|0.0300
72626261|NCT00402987|144781745|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.9||||0.127||95.0|-13.5|1.7||"Analysis at 2 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||1.7|-13.5|0.127
72532979|NCT05664672|144595395|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|109.0||||0.9851|TWO_SIDED|95.0|62.1|192.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||192|62.1|0.9851
72532980|NCT05664672|144595396|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|13.7|||<|0.0001|TWO_SIDED|95.0|9.72|19.2|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||19.2|9.72|<.0001
72532981|NCT05664672|144595396|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|16.6|||<|0.0001|TWO_SIDED|95.0|12.1|22.6|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||22.6|12.1|<.0001
72532982|NCT05664672|144595396|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|13.4|||<|0.0001|TWO_SIDED|95.0|9.68|18.6|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||18.6|9.68|<.0001
72532983|NCT05664672|144595396|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|15.7|||<|0.0001|TWO_SIDED|95.0|11.2|22.2|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||22.2|11.2|<.0001
72532984|NCT05664672|144595396|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|86.8||||0.7167|TWO_SIDED|95.0|60.6|124.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||124|60.6|0.7167
72532985|NCT05664672|144595396|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|105.0||||0.9864|TWO_SIDED|95.0|75.3|147.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||147|75.3|0.9864
72532986|NCT05664672|144595396|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|85.1||||0.5911|TWO_SIDED|95.0|60.1|120.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||120|60.1|0.5911
72532987|NCT05664672|144595397|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|29.6|||<|0.0001|TWO_SIDED|95.0|21.8|40.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||40.0|21.8|<.0001
72532988|NCT05664672|144595397|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|28.3|||<|0.0001|TWO_SIDED|95.0|21.5|37.4|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||37.4|21.5|<.0001
72532989|NCT05664672|144595397|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|33.1|||<|0.0001|TWO_SIDED|95.0|24.8|44.2|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||44.2|24.8|<.0001
72532990|NCT05664672|144595397|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|37.5|||<|0.0001|TWO_SIDED|95.0|27.7|50.9|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||50.9|27.7|<.0001
72532991|NCT05664672|144595397|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|78.8||||0.195|TWO_SIDED|95.0|57.3|108.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||108|57.3|0.1950
72532992|NCT05664672|144595397|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|75.5||||0.0699|TWO_SIDED|95.0|56.1|102.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||102|56.1|0.0699
72532993|NCT05664672|144595397|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|88.3||||0.7041|TWO_SIDED|95.0|64.7|120.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||120|64.7|0.7041
72532994|NCT05664672|144595398|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|13.3|||<|0.0001|TWO_SIDED|95.0|9.57|18.4|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||18.4|9.57|<.0001
72532995|NCT05664672|144595398|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|13.3|||<|0.0001|TWO_SIDED|95.0|9.84|17.9|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||17.9|9.84|<.0001
72532996|NCT05664672|144595398|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|13.6|||<|0.0001|TWO_SIDED|95.0|9.93|18.6|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||18.6|9.93|<.0001
72532997|NCT05664672|144595398|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|9.28|||<|0.0001|TWO_SIDED|95.0|6.67|12.9|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||12.9|6.67|<.0001
72532998|NCT05664672|144595398|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|143.0||||0.0404|TWO_SIDED|95.0|101.0|202.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||202|101|0.0404
72572364|NCT02906930|144672012|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|0.13||||0.0001|TWO_SIDED|95.0|0.04|0.36||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox||Oral Semaglutide 7 mg / Placebo|Time to initiation of rescue medication was analysed using a Cox proportional hazards model with treatment and region as categorical fixed effects and baseline HbA1c as covariate. Censoring time was one day before last day on trial product.||0.36|0.04|0.0001
72572365|NCT02906930|144672012|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|0.06||||0.0001|TWO_SIDED|95.0|0.01|0.26||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox||Oral Semaglutide 14 mg /Placebo|Time to initiation of rescue medication was analysed using a Cox proportional hazards model with treatment and region as categorical fixed effects and baseline HbA1c as covariate. Censoring time was one day before last day on trial product.||0.26|0.01|0.0001
72572366|NCT04796779|144672035|SUPERIORITY||||||<|0.001|||||||Direct likelihood model|The model was adjusted for the baseline value of the metric, age, prior CGM and pump use, and site as a random effect.||||||<0.001
72572367|NCT04796779|144672036|SUPERIORITY||||||<|0.001||||||To preserve the overall type I error for the multiple secondary outcomes, a hierarchical gatekeeping approach was used.|Robust regression using M-estimation|The model was adjusted for baseline value of the metric, age, prior CGM and pump use, and site as a fixed effect.||||||<0.001
72572368|NCT04796779|144672037|SUPERIORITY||||||<|0.001||||||To preserve the overall type I error for the multiple secondary outcomes, a hierarchical gatekeeping approach was used.|Direct likelihood model|The model was adjusted for the baseline value of the metric, age, prior CGM and pump use, and site as a random effect.||||||<0.001
72572369|NCT04796779|144672038|SUPERIORITY||||||<|0.001||||||To preserve the overall type I error for the multiple secondary outcomes, a hierarchical gatekeeping approach was used.|Direct likelihood model|The model was adjusted for the baseline value of the metric, age, prior CGM and pump use, and site as a random effect.||||||<0.001
72572370|NCT04796779|144672039|SUPERIORITY|||||||0.57||||||To preserve the overall type I error for the multiple secondary outcomes, a hierarchical gatekeeping approach was used.|Robust regression using M-estimation|The model was adjusted for the baseline value of the metric, age, prior CGM and pump use, and site as a fixed effect.||||||0.57
72572371|NCT00910091|144672114|SUPERIORITY_OR_OTHER|||||||0.1895|TWO_SIDED||||||Kaplan-Meier Analysis|||||||0.1895
72572372|NCT00910091|144672115|SUPERIORITY_OR_OTHER|||||||0.0203|TWO_SIDED||||||Kaplan-Meier Analysis|||||||0.0203
72572373|NCT00910091|144672117|SUPERIORITY_OR_OTHER|||||||0.698|TWO_SIDED||||||Kaplan-Meier Analysis|||||||0.6980
72572374|NCT00910091|144672118|SUPERIORITY_OR_OTHER|||||||0.3078|TWO_SIDED||||||Kaplan-Meier Analysis|||||||0.3078
72572375|NCT00910091|144672119|SUPERIORITY_OR_OTHER|||||||0.0484|TWO_SIDED||||||Kaplan-Meier Analysis|||||||0.0484
72572376|NCT01155024|144672159|NON_INFERIORITY_OR_EQUIVALENCE|10 participants required to detect one value change in rating for the SCS scale, with 80% power.|||||>|0.4||95.0||||Two-Sided|t-test, 2 sided|||Alpha level of 0.05||||>0.4
72572377|NCT00894738|144672203|SUPERIORITY_OR_OTHER|||||||0.49|TWO_SIDED|||||The p-value listed is for DEXA total percent fat and is not adjusted for multiple comparisons. The alpha level was set to 5%.|ANCOVA|||The null hypothesis is that mean DEXA total percent fat is similar between the two groups of interest. The primary statistical model consisted of treatment group as a 2-level factor (AP-Treated Vs Non-AP Treated) and DEXA total percent fat as a covariate. Carotid intima-media thickness (CIMT) was the dependent variable.||||0.49
72626262|NCT00402987|144781746|SUPERIORITY_OR_OTHER_LEGACY|||||||0.48||95.0||||"Analysis at 15 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.480
72532999|NCT05664672|144595398|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|143.0||||0.0243|TWO_SIDED|95.0|104.0|198.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||198|104|0.0243
72533000|NCT05664672|144595398|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|146.0||||0.0215|TWO_SIDED|95.0|105.0|205.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||205|105|0.0215
72533001|NCT05664672|144595399|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|5.37|||<|0.0001|TWO_SIDED|95.0|3.69|7.8|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||7.80|3.69|<.0001
72533002|NCT05664672|144595399|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|5.65|||<|0.0001|TWO_SIDED|95.0|4.01|7.96|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||7.96|4.01|<.0001
72533003|NCT05664672|144595399|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|5.61|||<|0.0001|TWO_SIDED|95.0|3.92|8.03|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||8.03|3.92|<.0001
72533004|NCT05664672|144595399|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|6.09|||<|0.0001|TWO_SIDED|95.0|4.17|8.89|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||8.89|4.17|<.0001
72533005|NCT05664672|144595399|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|88.1||||0.8335|TWO_SIDED|95.0|59.4|131.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||131|59.4|0.8335
72533006|NCT05664672|144595399|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|92.9||||0.9622|TWO_SIDED|95.0|64.2|134.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||134|64.2|0.9622
72533007|NCT05664672|144595399|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|92.1||||0.9531|TWO_SIDED|95.0|62.8|135.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||135|62.8|0.9531
72533008|NCT05664672|144595400|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|18.0|||<|0.0001|TWO_SIDED|95.0|14.4|22.3|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||22.3|14.4|<.0001
72533009|NCT05664672|144595400|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|18.0|||<|0.0001|TWO_SIDED|95.0|14.8|22.1|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||22.1|14.8|<.0001
72533010|NCT05664672|144595400|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|15.8|||<|0.0001|TWO_SIDED|95.0|12.8|19.4|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||19.4|12.8|<.0001
72533011|NCT05664672|144595400|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|18.2|||<|0.0001|TWO_SIDED|95.0|14.6|22.7|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||22.7|14.6|<.0001
72533012|NCT05664672|144595400|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|98.4||||0.9993|TWO_SIDED|95.0|78.2|124.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||124|78.2|0.9993
72533013|NCT05664672|144595400|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|98.9||||0.9998|TWO_SIDED|95.0|79.7|123.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||123|79.7|0.9998
72533014|NCT05664672|144595400|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|86.4||||0.3019|TWO_SIDED|95.0|69.1|108.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||108|69.1|0.3019
72533015|NCT05664672|144595401|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|18.3|||<|0.0001|TWO_SIDED|95.0|13.2|25.3|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||25.3|13.2|<.0001
72533016|NCT05664672|144595401|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|23.7|||<|0.0001|TWO_SIDED|95.0|17.6|31.9|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||31.9|17.6|<.0001
72533017|NCT05664672|144595401|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|19.3|||<|0.0001|TWO_SIDED|95.0|14.2|26.4|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||26.4|14.2|<.0001
72533018|NCT05664672|144595401|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|24.0|||<|0.0001|TWO_SIDED|95.0|17.3|33.3|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||33.3|17.3|<.0001
72533019|NCT05664672|144595401|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|76.1||||0.153|TWO_SIDED|95.0|54.0|107.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||107|54.0|0.1530
72533020|NCT05664672|144595401|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|98.6||||0.9999|TWO_SIDED|95.0|71.7|136.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||136|71.7|0.9999
72533021|NCT05664672|144595401|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|80.5||||0.3025|TWO_SIDED|95.0|57.8|112.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||112|57.8|0.3025
72533022|NCT05664672|144595402|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|22.7|||<|0.0001|TWO_SIDED|95.0|17.0|30.4|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||30.4|17.0|<.0001
72533023|NCT05664672|144595402|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|28.1|||<|0.0001|TWO_SIDED|95.0|21.6|36.6|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||36.6|21.6|<.0001
72533024|NCT05664672|144595402|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|27.5|||<|0.0001|TWO_SIDED|95.0|20.8|36.2|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||36.2|20.8|<.0001
72533025|NCT05664672|144595402|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|28.7|||<|0.0001|TWO_SIDED|95.0|21.4|38.4|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||38.4|21.4|<.0001
72533026|NCT05664672|144595402|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|79.4||||0.1843|TWO_SIDED|95.0|58.6|108.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||108|58.6|0.1843
72533027|NCT05664672|144595402|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|98.1||||0.9994|TWO_SIDED|95.0|73.9|130.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||130|73.9|0.9994
72533028|NCT05664672|144595402|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|95.9||||0.9891|TWO_SIDED|95.0|71.4|129.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||129|71.4|0.9891
72533029|NCT05664672|144595403|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|37.3|||<|0.0001|TWO_SIDED|95.0|30.4|45.7|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||45.7|30.4|<.0001
72533030|NCT05664672|144595403|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|44.0|||<|0.0001|TWO_SIDED|95.0|36.5|53.1|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||53.1|36.5|<.0001
72533031|NCT05664672|144595403|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|41.8|||<|0.0001|TWO_SIDED|95.0|34.4|50.9|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||50.9|34.4|<.0001
72533032|NCT05664672|144595403|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|42.9|||<|0.0001|TWO_SIDED|95.0|34.9|52.7|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||52.7|34.9|<.0001
72533033|NCT05664672|144595403|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|86.9||||0.3027|TWO_SIDED|95.0|70.0|108.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||108|70.0|0.3027
72533034|NCT05664672|144595403|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|103.0||||0.9926|TWO_SIDED|95.0|83.9|125.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||125|83.9|0.9926
72533035|NCT05664672|144595403|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|97.5||||0.9938|TWO_SIDED|95.0|79.1|120.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||120|79.1|0.9938
72533036|NCT05664672|144595404|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|46.3|||<|0.0001|TWO_SIDED|95.0|39.5|54.4|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||54.4|39.5|<.0001
72533037|NCT05664672|144595404|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|55.6|||<|0.0001|TWO_SIDED|95.0|48.0|64.4|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||64.4|48.0|<.0001
72533038|NCT05664672|144595404|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|52.7|||<|0.0001|TWO_SIDED|95.0|45.2|61.5|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||61.5|45.2|<.0001
72533039|NCT05664672|144595404|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|54.9|||<|0.0001|TWO_SIDED|95.0|46.7|64.5|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||64.5|46.7|<.0001
72533040|NCT05664672|144595404|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|84.4||||0.0504|TWO_SIDED|95.0|71.2|100.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||100|71.2|0.0504
72533041|NCT05664672|144595404|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|101.0||||0.9988|TWO_SIDED|95.0|86.4|119.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||119|86.4|0.9988
72533042|NCT05664672|144595404|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|96.0||||0.9238|TWO_SIDED|95.0|81.4|113.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||113|81.4|0.9238
72533043|NCT05664672|144595405|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|3.71|||<|0.0001|TWO_SIDED|95.0|1.88|7.31|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||7.31|1.88|<.0001
72533044|NCT05664672|144595405|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|4.25|||<|0.0001|TWO_SIDED|95.0|2.28|7.93|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||7.93|2.28|<.0001
72533045|NCT05664672|144595405|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|4.24|||<|0.0001|TWO_SIDED|95.0|2.2|8.14|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||8.14|2.20|<.0001
72533046|NCT05664672|144595405|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|6.4|||<|0.0001|TWO_SIDED|95.0|3.22|12.7|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||12.7|3.22|<.0001
72533047|NCT05664672|144595405|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|57.9||||0.184|TWO_SIDED|95.0|28.3|119.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||119|28.3|0.1840
72533048|NCT05664672|144595405|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|66.4||||0.3552|TWO_SIDED|95.0|34.0|130.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||130|34.0|0.3552
72533049|NCT05664672|144595405|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|66.2||||0.381|TWO_SIDED|95.0|33.0|133.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||133|33.0|0.3810
72533050|NCT05664672|144595406|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|16.8|||<|0.0001|TWO_SIDED|95.0|13.0|21.8|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||21.8|13.0|<.0001
72533051|NCT05664672|144595406|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|20.5|||<|0.0001|TWO_SIDED|95.0|16.2|25.9|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||25.9|16.2|<.0001
72533052|NCT05664672|144595406|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|18.2|||<|0.0001|TWO_SIDED|95.0|14.3|23.4|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||23.4|14.3|<.0001
72533053|NCT05664672|144595406|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|17.8|||<|0.0001|TWO_SIDED|95.0|13.7|23.1|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||23.1|13.7|<.0001
72533054|NCT05664672|144595406|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|94.5||||0.9589|TWO_SIDED|95.0|72.0|124.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||124|72.0|0.9589
72408008|NCT03238911|144324424|SUPERIORITY||Mean Difference (Final Values)|33.23|||<|0.0001|TWO_SIDED|95.0|26.62|39.84|||Mixed model for repeated measures|||"Day 7~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||39.84|26.62|<0.0001
72533055|NCT05664672|144595406|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|115.0||||0.4442|TWO_SIDED|95.0|89.3|148.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||148|89.3|0.4442
72533056|NCT05664672|144595406|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|103.0||||0.9975|TWO_SIDED|95.0|78.8|133.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||133|78.8|0.9975
72533057|NCT05664672|144595407|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|36.5|||<|0.0001|TWO_SIDED|95.0|23.9|55.6|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||55.6|23.9|<.0001
72533058|NCT05664672|144595407|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|39.9|||<|0.0001|TWO_SIDED|95.0|27.1|59.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||59.0|27.1|<.0001
72533059|NCT05664672|144595407|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|30.2|||<|0.0001|TWO_SIDED|95.0|20.1|45.5|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||45.5|20.1|<.0001
72533060|NCT05664672|144595407|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|48.9||||0.0002|TWO_SIDED|95.0|31.9|75.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||75.0|31.9|0.0002
72533061|NCT05664672|144595407|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|74.5||||0.2938|TWO_SIDED|95.0|47.6|117.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||117|47.6|0.2938
72533062|NCT05664672|144595407|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|81.6||||0.5552|TWO_SIDED|95.0|53.7|124.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||124|53.7|0.5552
72533063|NCT05664672|144595407|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|61.7||||0.0254|TWO_SIDED|95.0|39.9|95.5|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||95.5|39.9|0.0254
72533064|NCT05664672|144595408|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|52.1|||<|0.0001|TWO_SIDED|95.0|40.4|67.1|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||67.1|40.4|<.0001
72533065|NCT05664672|144595408|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|49.3|||<|0.0001|TWO_SIDED|95.0|39.0|62.2|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||62.2|39.0|<.0001
72533066|NCT05664672|144595408|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|40.8|||<|0.0001|TWO_SIDED|95.0|32.0|52.1|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||52.1|32.0|<.0001
72626263|NCT00402987|144781746|SUPERIORITY_OR_OTHER_LEGACY|||||||0.78||95.0||||"Analysis at 15 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.780
72533067|NCT05664672|144595408|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|45.9|||<|0.0001|TWO_SIDED|95.0|35.7|59.2|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||59.2|35.7|<.0001
72533068|NCT05664672|144595408|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|113.0||||0.5817|TWO_SIDED|95.0|86.8|148.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||148|86.8|0.5817
72533069|NCT05664672|144595408|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|107.0||||0.8852|TWO_SIDED|95.0|83.7|138.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||138|83.7|0.8852
72533070|NCT05664672|144595408|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|88.9||||0.607|TWO_SIDED|95.0|68.7|115.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||115|68.7|0.6070
72533071|NCT05664672|144595409|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|13.2|||<|0.0001|TWO_SIDED|95.0|5.44|32.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||32.0|5.44|<.0001
72533072|NCT05664672|144595409|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|23.8|||<|0.0001|TWO_SIDED|95.0|10.7|53.3|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||53.3|10.7|<.0001
72533073|NCT05664672|144595409|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|24.7||||0.0003|TWO_SIDED|95.0|10.6|57.4|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||57.4|10.6|0.0003
72533074|NCT05664672|144595409|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|22.3||||0.0002|TWO_SIDED|95.0|9.21|54.1|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||54.1|9.21|0.0002
72533075|NCT05664672|144595409|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|59.1||||0.428|TWO_SIDED|95.0|23.3|150.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||150|23.3|0.4280
72533076|NCT05664672|144595409|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|107.0||||0.999|TWO_SIDED|95.0|44.8|255.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||255|44.8|0.9990
72533077|NCT05664672|144595409|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|110.0||||0.9958|TWO_SIDED|95.0|44.9|272.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||272|44.9|0.9958
72533078|NCT05664672|144595410|SUPERIORITY||Ratio of geometric LS means|-50.8|||<|0.0001|TWO_SIDED|95.0|-77.7|-23.9|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric least squares means were calculated by transforming the natural-log LS means back to the linear scale. Est. para. is ratio of geometric LS means for natural-log (expressed as a percentage), natural-log transformed back to the linear scale.|||-23.9|-77.7|<.0001
72533079|NCT05664672|144595410|SUPERIORITY||Ratio of geometric LS means|-45.0|||<|0.0001|TWO_SIDED|95.0|-69.6|-20.3|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric least squares means were calculated by transforming the natural-log LS means back to the linear scale. Est. para. is ratio of geometric LS means for natural-log (expressed as a percentage), natural-log transformed back to the linear scale.|||-20.3|-69.6|<.0001
72533080|NCT05664672|144595410|SUPERIORITY||Ratio of geometric LS means|-42.3||||0.0003|TWO_SIDED|95.0|-68.2|-16.5|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric least squares means were calculated by transforming the natural-log LS means back to the linear scale. Est. para. is ratio of geometric LS means for natural-log (expressed as a percentage), natural-log transformed back to the linear scale.|||-16.5|-68.2|0.0003
72533081|NCT05664672|144595410|SUPERIORITY||Ratio of geometric LS means|-44.8||||0.0004|TWO_SIDED|95.0|-72.6|-17.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric least squares means were calculated by transforming the natural-log LS means back to the linear scale. Est. para. is ratio of geometric LS means for natural-log (expressed as a percentage), natural-log transformed back to the linear scale.|||-17.0|-72.6|0.0004
72533082|NCT05664672|144595410|SUPERIORITY||Ratio of geometric LS means|-6.05||||0.9551|TWO_SIDED|95.0|-35.2|23.1|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric least squares means were calculated by transforming the natural-log LS means back to the linear scale. Est. para. is ratio of geometric LS means for natural-log (expressed as a percentage), natural-log transformed back to the linear scale.|||23.1|-35.2|0.9551
72533083|NCT05664672|144595410|SUPERIORITY||Ratio of geometric LS means|-0.198||||1|TWO_SIDED|95.0|-27.3|26.9|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric least squares means were calculated by transforming the natural-log LS means back to the linear scale. Est. para. is ratio of geometric LS means for natural-log (expressed as a percentage), natural-log transformed back to the linear scale.|||26.9|-27.3|1.0000
72533084|NCT05664672|144595410|SUPERIORITY||Ratio of geometric LS means|2.48||||0.9981|TWO_SIDED|95.0|-25.6|30.6|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric least squares means were calculated by transforming the natural-log LS means back to the linear scale. Est. para. is ratio of geometric LS means for natural-log (expressed as a percentage), natural-log transformed back to the linear scale.|||30.6|-25.6|0.9981
72533085|NCT05664672|144595411|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|31.7|||<|0.0001|TWO_SIDED|95.0|18.7|53.9|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||53.9|18.7|<.0001
72533086|NCT05664672|144595411|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|28.5|||<|0.0001|TWO_SIDED|95.0|17.6|46.2|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||46.2|17.6|<.0001
72533087|NCT05664672|144595411|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|24.3|||<|0.0001|TWO_SIDED|95.0|14.7|40.2|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||40.2|14.7|<.0001
72533088|NCT05664672|144595411|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|28.1|||<|0.0001|TWO_SIDED|95.0|16.6|47.7|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||47.7|16.6|<.0001
72533089|NCT05664672|144595411|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|113.0||||0.9511|TWO_SIDED|95.0|64.7|197.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||197|64.7|0.9511
72533090|NCT05664672|144595411|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|101.0||||1|TWO_SIDED|95.0|60.4|170.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||170|60.4|1.0000
72533091|NCT05664672|144595411|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|86.5||||0.9003|TWO_SIDED|95.0|50.6|148.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||148|50.6|0.9003
72533092|NCT05664672|144595412|SUPERIORITY||Ratio of geometric LS means|46.4|||<|0.0001|TWO_SIDED|95.0|37.1|58.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric least squares means were calculated by transforming the natural-log LS means back to the linear scale. Est. para. is ratio of geometric LS means for natural-log (expressed as a percentage), natural-log transformed back to the linear scale.|||58.0|37.1|<.0001
72533093|NCT05664672|144595412|SUPERIORITY||Ratio of geometric LS means|43.1|||<|0.0001|TWO_SIDED|95.0|35.1|52.9|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric least squares means were calculated by transforming the natural-log LS means back to the linear scale. Est. para. is ratio of geometric LS means for natural-log (expressed as a percentage), natural-log transformed back to the linear scale.|||52.9|35.1|<.0001
72533094|NCT05664672|144595412|SUPERIORITY||Ratio of geometric LS means|44.1|||<|0.0001|TWO_SIDED|95.0|35.5|54.6|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric least squares means were calculated by transforming the natural-log LS means back to the linear scale. Est. para. is ratio of geometric LS means for natural-log (expressed as a percentage), natural-log transformed back to the linear scale.|||54.6|35.5|<.0001
72533095|NCT05664672|144595412|SUPERIORITY||Ratio of geometric LS means|39.1|||<|0.0001|TWO_SIDED|95.0|31.0|49.4|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric least squares means were calculated by transforming the natural-log LS means back to the linear scale. Est. para. is ratio of geometric LS means for natural-log (expressed as a percentage), natural-log transformed back to the linear scale.|||49.4|31.0|<.0001
72533096|NCT05664672|144595412|SUPERIORITY||Ratio of geometric LS means|119.0||||0.2351|TWO_SIDED|95.0|93.2|151.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric least squares means were calculated by transforming the natural-log LS means back to the linear scale. Est. para. is ratio of geometric LS means for natural-log (expressed as a percentage), natural-log transformed back to the linear scale.|||151|93.2|0.2351
72533097|NCT05664672|144595412|SUPERIORITY||Ratio of geometric LS means|110.0||||0.657|TWO_SIDED|95.0|87.7|138.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric least squares means were calculated by transforming the natural-log LS means back to the linear scale. Est. para. is ratio of geometric LS means for natural-log (expressed as a percentage), natural-log transformed back to the linear scale.|||138|87.7|0.6570
72533098|NCT05664672|144595412|SUPERIORITY||Ratio of geometric LS means|113.0||||0.5112|TWO_SIDED|95.0|89.1|142.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric least squares means were calculated by transforming the natural-log LS means back to the linear scale. Est. para. is ratio of geometric LS means for natural-log (expressed as a percentage), natural-log transformed back to the linear scale.|||142|89.1|0.5112
72533099|NCT01598831|144595423|SUPERIORITY||Risk Difference (RD)|-2.55||||0.318|TWO_SIDED|95.0|-3.68|8.77||The threshold for statistical significance was a two sided 5%|Cochran-Mantel-Haenszel|CMH test controlled for the stratification factor.|Rates by Arm are 26.8% for ART-123 and 29.4% for Placebo||In a post hoc sensitivity analysis for the primary outcome that accounted for pooled site as a random effect, the adjusted 28-day all-cause mortality rate was 24.8%in the rhsTM group vs 27.5%in the placebo group (P = .31).|8.77|-3.68|0.318
72533100|NCT02260791|144595503|EQUIVALENCE|-12% to +15% equivalence margin using 90% CI around the difference in ACR20 response rate|Mean Difference (Final Values)|-1.8|||||TWO_SIDED|90.0|-7.3|3.6||||||The difference and its 90% Confidence Interval (CI) for primary endpoint between FKB327 and Humira were estimated. If the 90% CI fell entirely between pre-specified equivalence margin (-12% to +15%), then FKB327 was considered equivalent to Humira.||3.6|-7.3|
72533101|NCT02260791|144595504|EQUIVALENCE|If the 2-sided 95% CI for the difference in DAS28-CRP at Week 24 between FKB327 and Humira fell entirely between -0.6 and +0.6 then FKB327 was considered equivalent to Humira.|Difference in least square mean|0.01|||||TWO_SIDED|95.0|-0.16|0.18||||||The secondary hypothesis involved equivalence of the difference between FKB327 and Humira in DAS28-CRP at Week 24. Based on the repeated measures analysis model, the difference and its 95% CI in the least-squares means (LSMs) for DAS28-CRP at Week 24 between FKB327 and Humira were estimated. If the 95% CI fell entirely between the pre-specified margin (+/- 0.6), then FKB327 was considered equivalent to Humira.||0.18|-0.16|
72533102|NCT04604015|144595533|OTHER||absolute difference|41.0|||<|0.001|TWO_SIDED|95.0|32.9|50.2|||McNemar|||The study was powered based on the results of a meta-analysis reporting the pooled NeuralBot (TCD) sensitivity for Right to Left Shunt detection, and the pooled TTE sensitivity for Right to Left Shunt detection.||50.2|32.9|<0.001
72533103|NCT01231620|144595534|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.73||||0.25|TWO_SIDED|95.0|-1.79|0.75|||Wilcoxon rank sum||IV Zanamivir 300 mg versus IV Zanamivir 600 mg|||0.75|-1.79|0.25
72533104|NCT01231620|144595534|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.48||||0.39|TWO_SIDED|95.0|-2.11|0.97|||Wilcoxon rank sum||Oral oseltamivir 75 mg versus IV Zanamivir 600 mg|||0.97|-2.11|0.39
72533105|NCT01231620|144595535|SUPERIORITY_OR_OTHER|||||||0.506|||||||Wei-Johnson method|||||||0.506
72533106|NCT01231620|144595535|SUPERIORITY_OR_OTHER|||||||0.41|||||||Wei-Johnson method|||||||0.41
72533107|NCT02486263|144595612|SUPERIORITY|||||||0.28||||||The threshold for statistical significance was \<0.05.|Chi-squared|||||||0.28
72533108|NCT02486263|144595613|SUPERIORITY||Odds Ratio (OR)|0.8||||0.99|TWO_SIDED|95.0|0.4|1.6||Used Bonferroni adjustment for multiple comparisons. Threshold for statistical significance was p\<0.05|Generalized Estimation Equation||Data presented as OR (95% CI) using Generalized Estimation Equation (GEE) model with Conventional as reference.|Generalized Estimation Equation (GEE) model was used for the comparison of differences between intervention groups from week 0 to week 5 for peristaltic response frequency.||1.6|0.4|0.99
72533109|NCT02486263|144595614|SUPERIORITY|Weight velocity in grams/day||||||0.64|||||||t-test, 2 sided|||||||0.64
72533110|NCT02486263|144595615|SUPERIORITY|||||||0.11|||||||Chi-squared|||||||0.11
72533111|NCT02486263|144595616|SUPERIORITY|||||||0.49||||||Threshold for statistical significance \<0.05|Chi-squared|||||||0.49
72533112|NCT02985541|144595617|OTHER||3-year probability of getting pregnant|0.68|||||TWO_SIDED|95.0|0.17|2.71||||||Cumulative failure rate (Kaplan-Meier) during Years 6-8||2.71|0.17|
72533113|NCT02558634|144595623|SUPERIORITY||Median Difference (Final Values)|1.25||||0.025|TWO_SIDED|95.0|0.75|1.75||The level of significance was set at p=0.025 to allow a Bonferroni correction for these two tests (i.e. p=0.050 divided by two).|Wilcoxon (Mann-Whitney)|||||1.75|0.75|0.025
72533114|NCT00798161|144595632|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.58|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001||95.0|-0.79|-0.36||hierarchical testing, no adjustment of p-values|ANCOVA|||Metformin 500mg vs. Linagliptin 2.5mg with Metformin 500mg||-0.36|-0.79|<0.0001
72533115|NCT00798161|144595632|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.51|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001||95.0|-0.73|-0.3||hierarchical testing, no adjustment of p-values|ANCOVA|||Metformin 1000mg vs. Linagliptin 2.5mg with Metformin 1000mg||-0.30|-0.73|<0.0001
72533116|NCT00798161|144595632|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.77|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001||95.0|-0.99|-0.55||hierarchical testing, no adjustment of p-values|ANCOVA|||Linagliptin 5mg vs. Linagliptin 2.5mg with Metformin 500mg||-0.55|-0.99|<0.0001
72533117|NCT00798161|144595632|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.14|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001||95.0|-1.36|-0.92||hierarchical testing, no adjustment of p-values|ANCOVA|||Linagliptin 5mg vs. Linagliptin 2.5mg with Metformin 1000mg||-0.92|-1.36|<0.0001
72626264|NCT00402987|144781746|SUPERIORITY_OR_OTHER_LEGACY|||||||0.667||95.0||||"Analysis at 15 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.667
72533118|NCT00798161|144595633|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.41|STANDARD_ERROR_OF_MEAN|0.08|<|0.0001||95.0|-0.56|-0.26|||ANCOVA|||Metformin 500mg vs. Linagliptin 2.5mg with Metformin 500mg||-0.26|-0.56|<0.0001
72533119|NCT00798161|144595633|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.38|STANDARD_ERROR_OF_MEAN|0.08|<|0.0001||95.0|-0.53|-0.23|||ANCOVA|||Metformin 1000mg vs. Linagliptin 2.5mg with Metformin 1000mg||-0.23|-0.53|<0.0001
72533120|NCT00798161|144595633|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|0.08|<|0.0001||95.0|-0.65|-0.35|||ANCOVA|||Linagliptin 5mg vs Linagliptin 2.5mg with metformin 500mg||-0.35|-0.65|<0.0001
72533121|NCT00798161|144595633|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.64|STANDARD_ERROR_OF_MEAN|0.08|<|0.0001||95.0|-0.79|-0.48|||ANCOVA|||Linagliptin 5mg vs. Linagliptin 2.5mg with Metformin 1000mg||-0.48|-0.79|<0.0001
72533122|NCT00798161|144595634|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.51|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001||95.0|-0.72|-0.31|||ANCOVA|||Metformin 500mg vs. Linagliptin 2.5mg with Metformin 500mg||-0.31|-0.72|<0.0001
72533123|NCT00798161|144595634|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.42|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001||95.0|-0.63|-0.22|||ANCOVA|||Metformin 1000mg vs. Linagliptin 2.5mg with Metformin 1000mg||-0.22|-0.63|<0.0001
72533124|NCT00798161|144595634|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.71|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001||95.0|-0.92|-0.51|||ANCOVA|||Linagliptin 5mg vs. Linagliptin 2.5mg with Metformin 500mg||-0.51|-0.92|<0.0001
72533125|NCT00798161|144595634|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.95|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001||95.0|-1.16|-0.75|||ANCOVA|||Linagliptin 5mg vs. Linagliptin 2.5mg with Metformin 1000mg||-0.75|-1.16|<0.0001
72533126|NCT00798161|144595635|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.51|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001||95.0|-0.73|-0.29|||ANCOVA|||Metformin 500mg vs. Linagliptin 2.5mg with Metformin 500mg||-0.29|-0.73|<0.0001
72626265|NCT00402987|144781746|SUPERIORITY_OR_OTHER_LEGACY|||||||0.153||95.0||||"Analysis at 30 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.153
72533127|NCT00798161|144595635|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.47|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001||95.0|-0.69|-0.26|||ANCOVA|||Metformin 1000mg vs. Linagliptin 2.5mg with Metformin 1000mg||-0.26|-0.69|<0.0001
72533128|NCT00798161|144595635|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.72|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001||95.0|-0.94|-0.49|||ANCOVA|||Linagliptin 5mg vs. Linagliptin 2.5mg with Metformin 500mg||-0.49|-0.94|<0.0001
72533129|NCT00798161|144595635|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.08|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001||95.0|-1.3|-0.86|||ANCOVA|||Linagliptin 5mg vs. Linagliptin 2.5mg with Metformin 1000mg||-0.86|-1.30|<0.0001
72533130|NCT00798161|144595636|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.4|STANDARD_ERROR_OF_MEAN|5.0||0.0005||95.0|-27.2|-7.6|||ANCOVA|||Metformin 500mg vs. Linagliptin 2.5mg with Metformin 500mg||-7.6|-27.2|0.0005
72533131|NCT00798161|144595636|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.2|STANDARD_ERROR_OF_MEAN|5.0||0.0006||95.0|-27.1|-7.3|||ANCOVA|||Metformin 1000mg vs. Linagliptin 2.5mg with Metformin 1000mg||-7.3|-27.1|0.0006
72533132|NCT00798161|144595636|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-24.6|STANDARD_ERROR_OF_MEAN|5.0|<|0.0001||95.0|-34.4|-14.8|||ANCOVA|||Linagliptin 5mg vs. Linagliptin 2.5mg with Metformin 500mg||-14.8|-34.4|<0.0001
72533133|NCT00798161|144595636|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-40.8|STANDARD_ERROR_OF_MEAN|5.0|<|0.0001||95.0|-50.6|-31.0|||ANCOVA|||Linagliptin 5mg vs. linagliptin 2.5mg with metformin 1000mg||-31.0|-50.6|<0.0001
72533134|NCT00798161|144595637|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.9|STANDARD_ERROR_OF_MEAN|4.1||0.0003||95.0|-22.9|-6.8|||ANCOVA|||Metformin 500mg vs. Linagliptin 2.5mg with Metformin 500mg||-6.8|-22.9|0.0003
72533135|NCT00798161|144595637|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.8|STANDARD_ERROR_OF_MEAN|4.1|<|0.0001||95.0|-24.9|-8.8|||ANCOVA|||Metformin 1000mg vs. Linagliptin 2.5mg with Metformin 1000mg||-8.8|-24.9|<0.0001
72533136|NCT00798161|144595637|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-21.5|STANDARD_ERROR_OF_MEAN|4.1|<|0.0001||95.0|-29.5|-13.4|||ANCOVA|||Linagliptin 5mg vs. Linagliptin 2.5mg with Metformin 500mg||-13.4|-29.5|<0.0001
72533137|NCT00798161|144595637|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-25.6|STANDARD_ERROR_OF_MEAN|4.1|<|0.0001||95.0|-33.6|-17.6|||ANCOVA|||Linagliptin 5mg vs. Linagliptin 2.5mg with Metformin 1000mg||-17.6|-33.6|<0.0001
72533138|NCT00798161|144595638|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.9|STANDARD_ERROR_OF_MEAN|4.5|<|0.0001||95.0|-26.7|-9.1|||ANCOVA|||Metformin 500mg vs. Linagliptin 2.5mg with Metformin 500mg||-9.1|-26.7|<0.0001
72533139|NCT00798161|144595638|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.8|STANDARD_ERROR_OF_MEAN|4.5||0.0002||95.0|-25.6|-7.9|||ANCOVA|||Metformin 1000mg vs. Linagliptin 2.5mg with Metformin 1000mg||-7.9|-25.6|0.0002
72533140|NCT00798161|144595638|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-27.9|STANDARD_ERROR_OF_MEAN|4.5|<|0.0001||95.0|-36.7|-19.1|||ANCOVA|||Linagliptin 5mg vs. Linagliptin 2.5mg with Metformin 500mg||-19.1|-36.7|<0.0001
72533141|NCT00798161|144595638|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-37.6|STANDARD_ERROR_OF_MEAN|4.5|<|0.0001||95.0|-46.4|-28.8|||ANCOVA|||Linagliptin 5mg vs. Linagliptin 2.5mg with Metformin 1000mg||-28.8|-46.4|<0.0001
72533142|NCT00798161|144595639|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.4|STANDARD_ERROR_OF_MEAN|4.7||0.0024||95.0|-23.7|-5.1|||ANCOVA|||Metformin 500mg vs. Linagliptin 2.5mg with Metformin 500mg||-5.1|-23.7|0.0024
72533143|NCT00798161|144595639|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-18.0|STANDARD_ERROR_OF_MEAN|4.8||0.0002||95.0|-27.4|-8.7|||ANCOVA|||Metformin 1000mg vs. Linagliptin 2.5mg with Metformin 1000mg||-8.7|-27.4|0.0002
72533144|NCT00798161|144595639|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-27.8|STANDARD_ERROR_OF_MEAN|4.7|<|0.0001||95.0|-37.1|-18.5|||ANCOVA|||Linagliptin 5mg vs. Linagliptin 2.5mg with Metformin 500mg||-18.5|-37.1|<0.0001
72533145|NCT00798161|144595639|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-41.5|STANDARD_ERROR_OF_MEAN|4.7|<|0.0001||95.0|-50.8|-32.2|||ANCOVA|||Linagliptin 5mg vs. Linagliptin 2.5mg with Metformin 1000mg||-32.2|-50.8|<0.0001
72533146|NCT00798161|144595640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-20.9|STANDARD_ERROR_OF_MEAN|4.8|<|0.0001||95.0|-30.4|-11.4|||ANCOVA|||Metformin 500mg vs. Linagliptin 2.5mg with Metformin 500mg||-11.4|-30.4|<0.0001
72533147|NCT00798161|144595640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.9|STANDARD_ERROR_OF_MEAN|4.9||0.0003||95.0|-27.4|-8.3|||ANCOVA|||Metformin 1000mg vs. Linagliptin 2.5mg with Metformin 1000mg||-8.3|-27.4|0.0003
72408009|NCT03238911|144324424|SUPERIORITY||Mean Difference (Final Values)|32.78|||<|0.0001|TWO_SIDED|95.0|25.71|39.84|||Mixed model for repeated measures|||"Day 8~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||39.84|25.71|<0.0001
72533148|NCT00798161|144595640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-25.4|STANDARD_ERROR_OF_MEAN|4.9|<|0.0001||95.0|-35.0|-15.9|||ANCOVA|||Linagliptin 5mg vs. Linagliptin 2.5mg with Metformin 500mg||-15.9|-35.0|<0.0001
72533149|NCT00798161|144595640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-39.0|STANDARD_ERROR_OF_MEAN|4.9|<|0.0001||95.0|-48.5|-29.4|||ANCOVA|||Linagliptin 5 mg vs. Linagliptin 2.5 mg with Metformin 1000 mg||-29.4|-48.5|<0.0001
72533150|NCT00798161|144595641|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.372||||0.0062||95.0|1.278|4.402|||Regression, Logistic|The odds-ratio is based on a logistic regression model including baseline HbA1c and previous antidiabetic medication.||Metformin 500mg vs. Linagliptin 2.5mg with Metformin 500mg||4.402|1.278|0.0062
72533151|NCT00798161|144595641|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.163|||<|0.0001||95.0|2.343|7.397|||Regression, Logistic|The odds-ratio is based on a logistic regression model including baseline HbA1c and previous antidiabetic medication.||Metformin 1000mg vs. Linagliptin 2.5mg with Metformin 1000mg||7.397|2.343|<0.0001
72408010|NCT03238911|144324424|SUPERIORITY||Mean Difference (Final Values)|42.11|||<|0.0001|TWO_SIDED|95.0|33.89|50.32|||Mixed model for repeated measures|||"Day 14~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||50.32|33.89|<0.0001
72533152|NCT00798161|144595641|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.854|||<|0.0001||95.0|2.363|9.973|||Regression, Logistic|The odds-ratio is based on a logistic regression model including baseline HbA1c and previous antidiabetic medication.||Linagliptin 5mg vs. Linagliptin 2.5mg with Metformin 500mg||9.973|2.363|<0.0001
72533153|NCT00798161|144595641|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|17.094|||<|0.0001||95.0|8.238|35.471|||Regression, Logistic|The odds-ratio is based on a logistic regression model including baseline HbA1c and previous antidiabetic medication.||Linagliptin 5mg vs. Linagliptin 2.5mg with Metformin 1000mg||35.471|8.238|<0.0001
72533154|NCT00798161|144595643|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.465||||0.0102||95.0|1.342|8.943|||Regression, Logistic|The odds-ratio is based on a logistic regression model including baseline HbA1c and previous antidiabetic medication.||Metformin 500mg vs. Linagliptin 2.5mg with Metformin 500mg||8.943|1.342|0.0102
72533155|NCT00798161|144595643|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.521||||0.0004||95.0|1.747|7.094|||Regression, Logistic|The odds-ratio is based on a logistic regression model including baseline HbA1c and previous antidiabetic medication.||Metformin 1000mg vs. Linagliptin 2.5mg with Metformin 1000mg||7.094|1.747|0.0004
72533156|NCT00798161|144595643|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.521||||0.0053||95.0|1.564|13.069|||Regression, Logistic|The odds-ratio is based on a logistic regression model including baseline HbA1c and previous antidiabetic medication.||Linagliptin 5mg vs. Linagliptin 2.5mg with Metformin 500mg||13.069|1.564|0.0053
72533157|NCT00798161|144595643|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|11.947|||<|0.0001||95.0|4.314|33.08|||Regression, Logistic|The odds-ratio is based on a logistic regression model including baseline HbA1c and previous antidiabetic medication.||Linagliptin 5mg vs. Linagliptin 2.5mg with Metformin 1000mg||33.080|4.314|<0.0001
72533158|NCT00798161|144595645|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.181|||<|0.0001||95.0|1.903|5.316|||Regression, Logistic|The odds-ratio is based on a logistic regression model including baseline HbA1c and previous antidiabetic medication.||Metformin 500mg vs. Linagliptin 2.5mg with Metformin 500mg||5.316|1.903|<0.0001
72533159|NCT00798161|144595645|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.382||||0.0027||95.0|1.352|4.196|||Regression, Logistic|The odds-ratio is based on a logistic regression model including baseline HbA1c and previous antidiabetic medication.||Metformin 1000mg vs. Linagliptin 2.5mg with Metformin 1000mg||4.196|1.352|0.0027
72533160|NCT00798161|144595645|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.622|||<|0.0001||95.0|2.153|6.093|||Regression, Logistic|The odds-ratio is based on a logistic regression model including baseline HbA1c and previous antidiabetic medication.||Linagliptin 5mg vs. Linagliptin 2.5mg with Metformin 500mg||6.093|2.153|<0.0001
72533161|NCT00798161|144595645|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.529|||<|0.0001||95.0|3.724|11.445|||Regression, Logistic|The odds-ratio is based on a logistic regression model including baseline HbA1c and previous antidiabetic medication.||Linagliptin 5mg vs. Linagliptin 2.5mg with Metformin 1000mg||11.445|3.724|<0.0001
72533162|NCT00798161|144595646|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.2|STANDARD_ERROR_OF_MEAN|22.7||0.8893||95.0|-48.5|42.2|||ANCOVA|||Metformin 500mg vs. Linagliptin 2.5mg with Metformin 500mg||42.2|-48.5|0.8893
72533163|NCT00798161|144595646|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-22.0|STANDARD_ERROR_OF_MEAN|22.1||0.3234||95.0|-66.2|22.2|||ANCOVA|||Metformin 1000mg vs. Linagliptin 2.5mg with Metformin 1000mg||22.2|-66.2|0.3234
72533164|NCT00798161|144595646|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-50.8|STANDARD_ERROR_OF_MEAN|23.8||0.0373||95.0|-98.5|-3.1|||ANCOVA|||Linagliptin 5mg vs. Linagliptin 2.5mg with Metformin 500mg||-3.1|-98.5|0.0373
72533165|NCT00798161|144595646|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-73.9|STANDARD_ERROR_OF_MEAN|22.7||0.0018||95.0|-119.3|-28.6|||ANCOVA|||Linagliptin 5mg vs. Linagliptin 2.5mg with Metformin 1000mg||-28.6|-119.3|0.0018
72533166|NCT00798161|144595649|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.326||||0.0445|TWO_SIDED|95.0|0.109|0.973|||Regression, Logistic|||||0.973|0.109|0.0445
72533167|NCT00798161|144595649|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.274||||0.0151|TWO_SIDED|95.0|0.096|0.779|||Regression, Logistic|||||0.779|0.096|0.0151
72626266|NCT00402987|144781746|SUPERIORITY_OR_OTHER_LEGACY|||||||0.479||95.0||||"Analysis at 30 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.479
72626267|NCT00402987|144781746|SUPERIORITY_OR_OTHER_LEGACY|||||||0.469||95.0||||"Analysis at 30 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.469
72626268|NCT00402987|144781746|SUPERIORITY_OR_OTHER_LEGACY|||||||0.062||95.0||||"Analysis at 45 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.062
72626269|NCT00402987|144781746|SUPERIORITY_OR_OTHER_LEGACY|||||||0.284||95.0||||"Analysis at 45 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.284
72533168|NCT00798161|144595649|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.42||||0.049|TWO_SIDED|95.0|0.177|0.996|||Regression, Logistic|||||0.996|0.177|0.0490
72533169|NCT00798161|144595649|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.598||||0.2617|TWO_SIDED|95.0|0.244|1.467|||Regression, Logistic|||||1.467|0.244|0.2617
72533170|NCT02918968|144595683|SUPERIORITY|The significance level was 0.05 (two-sided).|Hazard Ratio (HR)|0.42|||<|0.001|TWO_SIDED|95.0|0.29|0.61||P-value is based on a log-rank test stratified disease stages (M0/N0, M0/N1, or M1).|Log Rank||Hazard ratio and P-value calculated using unstratified Cox proportional hazards model with treatment and disease stages (M0/N0, M0/N1, or M1) as covariate.|||0.61|0.29|<0.001
72533171|NCT02918968|144595685|SUPERIORITY|The significance level was 0.05 (two-sided).|Risk Difference (RD)|37.8|||<|0.001|TWO_SIDED|95.0|25.2|50.4||P-value is based on Cochran-Mantel-Haenszel mean score test stratified disease stages (M0/N0, M0/N1, or M1).|Mantel Haenszel|Mantel Haenszel common risk difference|Difference of response rate.|\>=50% reduction||50.4|25.2|<0.001
72533172|NCT02918968|144595685|SUPERIORITY|The significance level was 0.05 (two-sided).|Risk Difference (RD)|38.4|||<|0.001|TWO_SIDED|95.0|26.3|50.4||P-value is based on Cochran-Mantel-Haenszel mean score test stratified disease stages (M0/N0, M0/N1, or M1).|Mantel Haenszel|Mantel Haenszel common risk difference|Difference of response rate|≥ 90% reduction||50.4|26.3|<0.001
72533173|NCT02918968|144595686|SUPERIORITY|The significance level was 0.05 (two-sided).|Risk Difference (RD)|40.7|||<|0.001|TWO_SIDED|95.0|28.3|53.1||P-value is based on Cochran-Mantel-Haenszel mean score test stratified disease stages (M0/N0, M0/N1, or M1).|Mantel Haenszel|Mantel Haenszel common risk difference|Difference of response rate.|≥ 50% reduction||53.1|28.3|<0.001
72533174|NCT02918968|144595686|SUPERIORITY|The significance level was 0.05 (two-sided).|Risk Difference (RD)|33.5|||<|0.001|TWO_SIDED|95.0|21.5|45.4||P-value is based on Cochran-Mantel-Haenszel mean score test stratified disease stages (M0/N0, M0/N1, or M1).|Mantel Haenszel|Mantel Haenszel common risk difference|Difference of response rate|≥90% reduction||45.4|21.5|<0.001
72533175|NCT02918968|144595687|SUPERIORITY|The significance level was 0.05 (two-sided).|||||<|0.001||||||P-value is based on a log-rank test stratified disease stages (M0/N0, M0/N1, or M1).|Log Rank|||||||<0.001
72533176|NCT02918968|144595688|SUPERIORITY|The significance level was 0.05 (two-sided).|||||<|0.001||||||P-value is based on a log-rank test stratified disease stages (M0/N0, M0/N1, or M1).|Log Rank|||||||<0.001
72533177|NCT02918968|144595690|SUPERIORITY|The significance level was 0.05 (two-sided).|Hazard Ratio (HR)|0.87||||0.669|TWO_SIDED|95.0|0.45|1.67||P-value is based on a log-rank test stratified disease stages (M0/N0, M0/N1, or M1)|Log Rank||Hazard ratio and P-value calculated using unstratified Cox proportional hazards model with treatment and disease stages (M0/N0, M0/N1, or M1) as covariate.|||1.67|0.45|0.669
72533178|NCT00727246|144595710|OTHER|||||||0.85|TWO_SIDED|95.0|||||ANOVA|A repeated measures ANOVA was completed to evaluate differences in cognitive composite scores between groups and CDP-Choline or placebo||A repeated measures ANOVA was completed to evaluate differences in cognitive composite scores of individuals with a history of TBI as compared to healthy controls 6 weeks after treatment with CDP Choline (1000 mg CDP-Choline 2 x per day for 6 weeks) as compared to those treated with placebo. A mean index score created as a composite cognitive performance across domains (higher t-score = higher cognition). Purpose was to serve as a measure of overall cognitive functioning for data analysis.||||.85
72533179|NCT00727246|144595711|OTHER|||||||0.329|TWO_SIDED|0.95|||||ANOVA|A repeated measures ANOVA was completed to evaluate differences in cognitive composite scores between groups and CDP-Choline or placebo||A repeated measure ANOVA was completed to evaluate potential differences in cognitive composite scores of individuals with a history of TBI as compared to healthy controls 6 weeks after treatment with CDP Choline (1000 mg CDP-Choline 2 x per day for 6 weeks) as compared to those treated with placebo.||||.329
72533180|NCT03781167|144595852|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 1 vs Baseline||||<0.001
72533181|NCT03781167|144595852|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 1 vs Baseline||||<0.001
72533182|NCT03781167|144595852|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 1 vs Baseline||||<0.001
72533183|NCT03781167|144595852|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 6 vs Baseline||||<0.001
72533184|NCT03781167|144595852|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 6 vs Baseline||||<0.001
72533185|NCT03781167|144595852|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 6 vs Baseline||||<0.001
72533186|NCT03781167|144595852|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 13 vs Baseline||||<0.001
72626270|NCT00402987|144781746|SUPERIORITY_OR_OTHER_LEGACY|||||||0.421||95.0||||"Analysis at 45 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.421
72626271|NCT00402987|144781746|SUPERIORITY_OR_OTHER_LEGACY|||||||0.022||95.0||||"Analysis at 60 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.022
72533187|NCT03781167|144595852|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 13 vs Baseline||||<0.001
72533188|NCT03781167|144595852|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 13 vs Baseline||||<0.001
72533189|NCT03781167|144595852|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 26 vs Baseline||||<0.001
72533190|NCT03781167|144595852|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 26 vs Baseline||||<0.001
72533191|NCT03781167|144595852|SUPERIORITY|Week 26 vs Baseline|||||<|0.001|||||||paired-sample t-test|||Week 26 vs Baseline||||<0.001
72533192|NCT03781167|144595852|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 39 vs Baseline||||<0.001
72533193|NCT03781167|144595852|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 39 vs Baseline||||<0.001
72533194|NCT03781167|144595852|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 39 vs Baseline||||<0.001
72533195|NCT03781167|144595852|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 52 vs Baseline||||<0.001
72533196|NCT03781167|144595852|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 52 vs Baseline||||<0.001
72533197|NCT03781167|144595852|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 52 vs Baseline||||<0.001
72533198|NCT03781167|144595853|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||>|0.999|||||||paired-sample t-test|||Week 1 vs Baseline||||>0.999
72533199|NCT03781167|144595853|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.5095|||||||paired-sample t-test|||Week 1 vs Baseline||||=0.5095
72533200|NCT03781167|144595853|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.6962|||||||paired-sample t-test|||Week 1 vs Baseline||||=0.6962
72533201|NCT03781167|144595853|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.0035|||||||paired-sample t-test|||Week 6 vs Baseline||||=0.0035
72533202|NCT03781167|144595853|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.0324|||||||paired-sample t-test|||Week 6 vs Baseline||||=0.0324
72533203|NCT03781167|144595853|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 6 vs Baseline||||<0.001
72533204|NCT03781167|144595853|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.0072|||||||paired-sample t-test|||Week 13 vs Baseline||||=0.0072
72533205|NCT03781167|144595853|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.0129|||||||paired-sample t-test|||Week 13 vs Baseline||||=0.0129
72533206|NCT03781167|144595853|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 13 vs Baseline||||<0.001
72533207|NCT03781167|144595853|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.0119|||||||paired-sample t-test|||Week 26 vs Baseline||||=0.0119
72533208|NCT03781167|144595853|SUPERIORITY||||||=|0.22||||||A paired-sample t-test was performed to test the change from Baseline.|paired-sample t-test|||Week 26 vs Baseline||||=0.2200
72533209|NCT03781167|144595853|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.0063|||||||paired-sample t-test|||Week 26 vs Baseline||||=0.0063
72533210|NCT03781167|144595853|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 39 vs Baseline||||<0.001
72533211|NCT03781167|144595853|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.4331|||||||paired-sample t-test|||Week 39 vs Baseline||||=0.4331
72533212|NCT03781167|144595853|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.0045|||||||paired-sample t-test|||Week 39 vs Baseline||||=0.0045
72533213|NCT03781167|144595853|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.0049|||||||Wilcoxon (Mann-Whitney)|||Week 52 vs Baseline||||=0.0049
72533214|NCT03781167|144595853|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.6312|||||||paired-sample t-test|||Week 52 vs Baseline||||=0.6312
72533215|NCT03781167|144595853|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.1892|||||||paired-sample t-test|||Week 52 vs Baseline||||=0.1892
72533216|NCT03781167|144595854|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 1 vs Baseline||||<0.001
72533217|NCT03781167|144595854|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 1 vs Baseline||||<0.001
72533218|NCT03781167|144595854|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 1 vs Baseline||||<0.001
72533219|NCT03781167|144595854|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 6 vs Baseline||||<0.001
72533220|NCT03781167|144595854|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 6 vs Baseline||||<0.001
72533221|NCT03781167|144595854|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 6 vs Baseline||||<0.001
72533222|NCT03781167|144595854|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 13 vs Baseline||||<0.001
72533223|NCT03781167|144595854|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 13 vs Baseline||||<0.001
72533224|NCT03781167|144595854|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 13 vs Baseline||||<0.001
72533225|NCT03781167|144595854|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 26 vs Baseline||||<0.001
72533226|NCT03781167|144595854|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 26 vs Baseline||||<0.001
72533227|NCT03781167|144595854|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 26 vs Baseline||||<0.001
72533228|NCT03781167|144595854|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 39 vs Baseline||||<0.001
72533229|NCT03781167|144595854|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 39 vs Baseline||||<0.001
72533230|NCT03781167|144595854|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 39 vs Baseline||||<0.001
72533231|NCT03781167|144595854|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 52 vs Baseline||||<0.001
72533232|NCT03781167|144595854|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 52 vs Baseline||||<0.001
72533233|NCT03781167|144595854|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 52 vs Baseline||||<0.001
72533234|NCT03781167|144595855|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Day 2 vs Baseline||||<0.001
72533235|NCT03781167|144595855|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Day 2 vs Baseline||||<0.001
72533236|NCT03781167|144595855|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Day 2 vs Baseline||||<0.001
72533237|NCT03781167|144595855|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 1 vs Baseline||||<0.001
72533238|NCT03781167|144595855|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 1 vs Baseline||||<0.001
72533239|NCT03781167|144595855|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 1 vs Baseline||||<0.001
72533240|NCT03781167|144595855|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 2 vs Baseline||||<0.001
72533241|NCT03781167|144595855|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 2 vs Baseline||||<0.001
72533242|NCT03781167|144595855|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 2 vs Baseline||||<0.001
72533243|NCT03781167|144595855|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 3 vs Baseline||||<0.001
72533244|NCT03781167|144595855|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 3 vs Baseline||||<0.001
72533245|NCT03781167|144595855|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 3 vs Baseline||||<0.001
72533246|NCT03781167|144595855|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.0042|||||||paired-sample t-test|||Week 4 vs Baseline||||=0.0042
72533247|NCT03781167|144595855|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 4 vs Baseline||||<0.001
72533248|NCT03781167|144595855|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 4 vs Baseline||||<0.001
72533249|NCT03781167|144595855|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.1135|||||||paired-sample t-test|||Week 6 vs Baseline||||=0.1135
72533250|NCT03781167|144595855|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.0029|||||||paired-sample t-test|||Week 6 vs Baseline||||=0.0029
72533251|NCT03781167|144595855|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.0026|||||||paired-sample t-test|||Week 6 vs Baseline||||=0.0026
72533252|NCT03781167|144595855|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.0034|||||||paired-sample t-test|||Week 13 vs Baseline||||=0.0034
72533253|NCT03781167|144595855|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.0103|||||||paired-sample t-test|||Week 13 vs Baseline||||=0.0103
72533254|NCT03781167|144595855|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 13 vs Baseline||||<0.001
72533255|NCT03781167|144595855|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.0493|||||||paired-sample t-test|||Week 26 vs Baseline||||=0.0493
72533256|NCT03781167|144595855|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.3003|||||||paired-sample t-test|||Week 26 vs Baseline||||=0.3003
72533257|NCT03781167|144595855|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.0354|||||||paired-sample t-test|||Week 26 vs Baseline||||=0.0354
72533258|NCT03781167|144595855|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.2553|||||||paired-sample t-test|||Week 39 vs Baseline||||=0.2553
72533259|NCT03781167|144595855|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.864|||||||paired-sample t-test|||Week 39 vs Baseline||||=0.8640
72533260|NCT03781167|144595855|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.4774|||||||paired-sample t-test|||Week 39 vs Baseline||||=0.4774
72533261|NCT03781167|144595855|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.3865|||||||paired-sample t-test|||Week 52 vs Baseline||||=0.3865
72533262|NCT03781167|144595855|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.||||||0.1186|||||||paired-sample t-test|||Week 52 vs Baseline||||0.1186
72533263|NCT03781167|144595855|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.083|||||||paired-sample t-test|||Week 52 vs Baseline||||=0.0830
72533264|NCT03781167|144595856|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Day 2 vs Baseline||||<0.001
72533265|NCT03781167|144595856|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.0041|||||||paired-sample t-test|||Day 2 vs Baseline||||=0.0041
72533266|NCT03781167|144595856|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Day 2 vs Baseline||||<0.001
72533267|NCT03781167|144595856|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 1 vs Baseline||||<0.001
72533268|NCT03781167|144595856|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 1 vs Baseline||||<0.001
72533269|NCT03781167|144595856|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 1 vs Baseline||||<0.001
72533270|NCT03781167|144595856|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 2 vs Baseline||||<0.001
72533271|NCT03781167|144595856|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 2 vs Baseline||||<0.001
72533272|NCT03781167|144595856|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 2 vs Baseline||||<0.001
72572378|NCT00894738|144672204|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||The p-value listed is for DEXA total percent fat and is not adjusted for multiple comparisons. The alpha level was set to 5%.|ANCOVA|||The statistical analysis consisted of treatment group as a 2-level factor variable and DEXA total percent fat as a covariate. An interaction term between treatment group and DEXA total percent fat was also generated. Hepatic triglyceride content was the dependent variable. DEXA total percent fat was found to be significant while treatment group and the interaction between treatment group and DEXA total percent fat were not significant.||||<0.0001
72572379|NCT03397771|144672213|OTHER||Odds Ratio (OR)|1.0||||0.963|TWO_SIDED||||||Regression, Logistic|||||||0.963
72572380|NCT03397771|144672214|NON_INFERIORITY|The analysis was conducted according to the nul hypothesis, assuming no difference between treatment arms||||||0.022|||||||ANCOVA|||||||0.022
72533273|NCT03781167|144595856|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 3 vs Baseline||||<0.001
72533274|NCT03781167|144595856|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 3 vs Baseline||||<0.001
72533275|NCT03781167|144595856|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 3 vs Baseline||||<0.001
72533276|NCT03781167|144595856|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 4 vs Baseline||||<0.001
72533277|NCT03781167|144595856|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 4 vs Baseline||||<0.001
72533278|NCT03781167|144595856|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 4 vs Baseline||||<0.001
72533279|NCT03781167|144595856|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 6 vs Baseline||||<0.001
72533280|NCT03781167|144595856|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 6 vs Baseline||||<0.001
72533281|NCT03781167|144595856|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 6 vs Baseline||||<0.001
72533282|NCT03781167|144595856|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 13 vs Baseline||||<0.001
72533283|NCT03781167|144595856|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 13 vs Baseline||||<0.001
72533284|NCT03781167|144595856|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 13 vs Baseline||||<0.001
72533285|NCT03781167|144595856|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 26 vs Baseline||||<0.001
72533286|NCT03781167|144595856|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 26 vs Baseline||||<0.001
72533287|NCT03781167|144595856|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 26 vs Baseline||||<0.001
72533288|NCT03781167|144595856|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 39 vs Baseline||||<0.001
72533289|NCT03781167|144595856|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 39 vs Baseline||||<0.001
72533290|NCT03781167|144595856|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 39 vs Baseline||||<0.001
72533291|NCT03781167|144595856|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.0091|||||||paired-sample t-test|||Week 52 vs Baseline||||=0.0091
72533292|NCT03781167|144595856|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 52 vs Baseline||||<0.001
72533293|NCT03781167|144595856|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 52 vs Baseline||||<0.001
72533294|NCT03781167|144595857|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.4447|||||||paired-sample t-test|||Day 2 vs Baseline||||=0.4447
72533295|NCT03781167|144595857|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.3567|||||||paired-sample t-test|||Day 2 vs Baseline||||=0.3567
72533296|NCT03781167|144595857|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.2315|||||||paired-sample t-test|||Day 2 vs Baseline||||=0.2315
72572381|NCT03801265|144672215|NON_INFERIORITY|The margin of non-inferiority is 0.5. The true difference between the means is assumed to be -0.2. The significance level (alpha) of the test is 0.05. The data are drawn from populations with standard deviations of 0.7 and 0.3 (PASS 15 Power Analysis and Sample Size Software (2017). NCSS, LLC. Kaysville, Utah, USA, ncss.com/software/pass).||||||0.77|||||||Wilcoxon (Mann-Whitney)|||||||.770
72533297|NCT03781167|144595857|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.0667|||||||paired-sample t-test|||Week 1 vs Baseline||||=0.0667
72533298|NCT03781167|144595857|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 1 vs Baseline||||<0.001
72533299|NCT03781167|144595857|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 1 vs Baseline||||<0.001
72533300|NCT03781167|144595857|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 2 vs Baseline||||<0.001
72533301|NCT03781167|144595857|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.2033|||||||paired-sample t-test|||Week 2 vs Baseline||||=0.2033
72533302|NCT03781167|144595857|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 2 vs Baseline||||<0.001
72533303|NCT03781167|144595857|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.0012|||||||paired-sample t-test|||Week 3 vs Baseline||||=0.0012
72533304|NCT03781167|144595857|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.0734|||||||paired-sample t-test|||Week 3 vs Baseline||||=0.0734
72572382|NCT03801265|144672216|NON_INFERIORITY|The margin of non-inferiority is 0.5. The true difference between the means is assumed to be -0.2. The significance level (alpha) of the test is 0.05. The data are drawn from populations with standard deviations of 0.7 and 0.3 (PASS 15 Power Analysis and Sample Size Software (2017). NCSS, LLC. Kaysville, Utah, USA, ncss.com/software/pass).||||||0.826|||||||Wilcoxon (Mann-Whitney)|||||||.826
72572383|NCT03801265|144672217|NON_INFERIORITY|The margin of non-inferiority is 0.5. The true difference between the means is assumed to be -0.2. The significance level (alpha) of the test is 0.05. The data are drawn from populations with standard deviations of 0.7 and 0.3 (PASS 15 Power Analysis and Sample Size Software (2017). NCSS, LLC. Kaysville, Utah, USA, ncss.com/software/pass).||||||0.859|||||||Wilcoxon (Mann-Whitney)|||||||.859
72533305|NCT03781167|144595857|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 3 vs Baseline||||<0.001
72533306|NCT03781167|144595857|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.0304|||||||paired-sample t-test|||Week 4 vs Baseline||||=0.0304
72533307|NCT03781167|144595857|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||>|0.999|||||||paired-sample t-test|||Week 4 vs Baseline||||>0.999
72533308|NCT03781167|144595857|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.0891|||||||paired-sample t-test|||Week 4 vs Baseline||||=0.0891
72533309|NCT03781167|144595857|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.0832|||||||paired-sample t-test|||Week 6 vs Baseline||||=0.0832
72533310|NCT03781167|144595857|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.4941|||||||paired-sample t-test|||Week 6 vs Baseline||||=0.4941
72533311|NCT03781167|144595857|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.2764|||||||paired-sample t-test|||Week 6 vs Baseline||||=0.2764
72533312|NCT03781167|144595857|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.3248|||||||paired-sample t-test|||Week 13 vs Baseline||||=0.3248
72533313|NCT03781167|144595857|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.2535|||||||paired-sample t-test|||Week 13 vs Baseline||||=0.2535
72533314|NCT03781167|144595857|OTHER|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.9274|||||||paired-sample t-test|||Week 13 vs Baseline||||=0.9274
72533315|NCT03781167|144595857|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.3297|||||||paired-sample t-test|||Week 26 vs Baseline||||=0.3297
72533316|NCT03781167|144595857|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.9722|||||||paired-sample t-test|||Week 26 vs Baseline||||=0.9722
72533317|NCT03781167|144595857|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.4403|||||||paired-sample t-test|||Week 26 vs Baseline||||=0.4403
72533318|NCT03781167|144595857|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.1946|||||||paired-sample t-test|||Week 39 vs Baseline||||=0.1946
72533319|NCT03781167|144595857|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.2077|||||||paired-sample t-test|||Week 39 vs Baseline||||=0.2077
72533320|NCT03781167|144595857|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.0692|||||||paired-sample t-test|||Week 39 vs Baseline||||=0.0692
72533321|NCT03781167|144595857|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.2276|||||||paired-sample t-test|||Week 52 vs Baseline||||=0.2276
72533322|NCT03781167|144595857|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.||||||0.3369|||||||paired-sample t-test|||Week 52 vs Baseline||||0.3369
72533323|NCT03781167|144595857|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.1218|||||||paired-sample t-test|||Week 52 vs Baseline||||=0.1218
72533324|NCT03781167|144595858|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Day 2 vs Baseline||||<0.001
72533325|NCT03781167|144595858|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.002|||||||paired-sample t-test|||Day 2 vs Baseline||||=0.0020
72533326|NCT03781167|144595858|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 1 vs Baseline||||<0.001
72533327|NCT03781167|144595858|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 1 vs Baseline||||<0.001
72533328|NCT03781167|144595858|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 1 vs Baseline||||<0.001
72533329|NCT03781167|144595858|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Day 2 vs Baseline||||<0.001
72533330|NCT03781167|144595858|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 2 vs Baseline||||<0.001
72626272|NCT00402987|144781746|SUPERIORITY_OR_OTHER_LEGACY|||||||0.171||95.0||||"Analysis at 60 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.171
72626273|NCT00402987|144781746|SUPERIORITY_OR_OTHER_LEGACY|||||||0.354||95.0||||"Analysis at 60 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.354
72626274|NCT00402987|144781746|SUPERIORITY_OR_OTHER_LEGACY|||||||0.005||95.0||||"Analysis at 75 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.005
72626275|NCT00402987|144781746|SUPERIORITY_OR_OTHER_LEGACY|||||||0.09||95.0||||"Analysis at 75 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.090
72626276|NCT00402987|144781746|SUPERIORITY_OR_OTHER_LEGACY|||||||0.262||95.0||||"Analysis at 75 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.262
72626277|NCT00402987|144781746|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001||95.0||||"Analysis at 90 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.001
72626278|NCT00402987|144781746|SUPERIORITY_OR_OTHER_LEGACY|||||||0.044||95.0||||"Analysis at 90 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.044
72626279|NCT00402987|144781746|SUPERIORITY_OR_OTHER_LEGACY|||||||0.194||95.0||||"Analysis at 90 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.194
72626280|NCT00402987|144781746|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 1.75 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
72626281|NCT00402987|144781746|SUPERIORITY_OR_OTHER_LEGACY|||||||0.02||95.0||||"Analysis at 1.75 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.020
72626282|NCT00402987|144781746|SUPERIORITY_OR_OTHER_LEGACY|||||||0.148||95.0||||"Analysis at 1.75 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.148
72533331|NCT03781167|144595858|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 2 vs Baseline||||<0.001
72533332|NCT03781167|144595858|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 2 vs Baseline||||<0.001
72533333|NCT03781167|144595858|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 3 vs Baseline||||<0.001
72626283|NCT00402987|144781746|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 2 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
72626284|NCT00402987|144781746|SUPERIORITY_OR_OTHER_LEGACY|||||||0.009||95.0||||"Analysis at 2 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.009
72626285|NCT00402987|144781746|SUPERIORITY_OR_OTHER_LEGACY|||||||0.127||95.0||||"Analysis at 2 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.127
72626286|NCT00402987|144781746|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 3 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
72533334|NCT03781167|144595858|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 3 vs Baseline||||<0.001
72533335|NCT03781167|144595858|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 3 vs Baseline||||<0.001
72533336|NCT03781167|144595858|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 4 vs Baseline||||<0.001
72533337|NCT03781167|144595858|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 4 vs Baseline||||<0.001
72533338|NCT03781167|144595858|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 4 vs Baseline||||<0.001
72533339|NCT03781167|144595858|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 6 vs Baseline||||<0.001
72626287|NCT00402987|144781746|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001||95.0||||"Analysis at 3 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.001
72626288|NCT00402987|144781746|SUPERIORITY_OR_OTHER_LEGACY|||||||0.122||95.0||||"Analysis at 3 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.122
72626289|NCT00402987|144781746|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 4 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
72626290|NCT00402987|144781746|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 4 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
72408011|NCT03238911|144324424|SUPERIORITY||Mean Difference (Final Values)|32.28|||<|0.0001|TWO_SIDED|95.0|23.09|41.48|||Mixed model for repeated measures|||"Day 21~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||41.48|23.09|<0.0001
72533340|NCT03781167|144595858|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 6 vs Baseline||||<0.001
72533341|NCT03781167|144595858|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 6 vs Baseline||||<0.001
72533342|NCT03781167|144595858|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 13 vs Baseline||||<0.001
72533343|NCT03781167|144595858|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 13 vs Baseline||||<0.001
72533344|NCT03781167|144595858|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 13 vs Baseline||||<0.001
72533345|NCT03781167|144595858|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 26 vs Baseline||||<0.001
72572384|NCT03801265|144672218|NON_INFERIORITY|The margin of non-inferiority is 0.5. The true difference between the means is assumed to be -0.2. The significance level (alpha) of the test is 0.05. The data are drawn from populations with standard deviations of 0.7 and 0.3 (PASS 15 Power Analysis and Sample Size Software (2017). NCSS, LLC. Kaysville, Utah, USA, ncss.com/software/pass).||||||0.904|||||||Wilcoxon (Mann-Whitney)|||||||.904
72572385|NCT03801265|144672219|NON_INFERIORITY|The margin of non-inferiority is 0.5. The true difference between the means is assumed to be -0.2. The significance level (alpha) of the test is 0.05. The data are drawn from populations with standard deviations of 0.7 and 0.3 (PASS 15 Power Analysis and Sample Size Software (2017). NCSS, LLC. Kaysville, Utah, USA, ncss.com/software/pass).||||||0.122|||||||Wilcoxon (Mann-Whitney)|||||||.122
72572386|NCT03801265|144672220|NON_INFERIORITY|The margin of non-inferiority is 0.5. The true difference between the means is assumed to be -0.2. The significance level (alpha) of the test is 0.05. The data are drawn from populations with standard deviations of 0.7 and 0.3 (PASS 15 Power Analysis and Sample Size Software (2017). NCSS, LLC. Kaysville, Utah, USA, ncss.com/software/pass).||||||0.379|||||||Wilcoxon (Mann-Whitney)|||||||.379
72572387|NCT03801265|144672221|NON_INFERIORITY|The margin of non-inferiority is 0.5. The true difference between the means is assumed to be -0.2. The significance level (alpha) of the test is 0.05. The data are drawn from populations with standard deviations of 0.7 and 0.3 (PASS 15 Power Analysis and Sample Size Software (2017). NCSS, LLC. Kaysville, Utah, USA, ncss.com/software/pass).||||||0.881|||||||Wilcoxon (Mann-Whitney)|||||||.881
72572388|NCT03801265|144672222|NON_INFERIORITY|The margin of non-inferiority is 0.5. The true difference between the means is assumed to be -0.2. The significance level (alpha) of the test is 0.05. The data are drawn from populations with standard deviations of 0.7 and 0.3 (PASS 15 Power Analysis and Sample Size Software (2017). NCSS, LLC. Kaysville, Utah, USA, ncss.com/software/pass).||||||0.818|||||||Wilcoxon (Mann-Whitney)|||||||.818
72572389|NCT03801265|144672223|NON_INFERIORITY|The margin of non-inferiority is 0.5. The true difference between the means is assumed to be -0.2. The significance level (alpha) of the test is 0.05. The data are drawn from populations with standard deviations of 0.7 and 0.3 (PASS 15 Power Analysis and Sample Size Software (2017). NCSS, LLC. Kaysville, Utah, USA, ncss.com/software/pass).||||||0.678|||||||Wilcoxon (Mann-Whitney)|||||||.678
72572390|NCT03801265|144672224|NON_INFERIORITY|The margin of non-inferiority is 0.5. The true difference between the means is assumed to be -0.2. The significance level (alpha) of the test is 0.05. The data are drawn from populations with standard deviations of 0.7 and 0.3 (PASS 15 Power Analysis and Sample Size Software (2017). NCSS, LLC. Kaysville, Utah, USA, ncss.com/software/pass).||||||0.002|||||||Wilcoxon (Mann-Whitney)|||||||.002
72572391|NCT03801265|144672225|NON_INFERIORITY|The margin of non-inferiority is 0.5. The true difference between the means is assumed to be -0.2. The significance level (alpha) of the test is 0.05. The data are drawn from populations with standard deviations of 0.7 and 0.3 (PASS 15 Power Analysis and Sample Size Software (2017). NCSS, LLC. Kaysville, Utah, USA, ncss.com/software/pass).||||||0.007|||||||Chi-squared|||||||.007
72572392|NCT03801265|144672226|NON_INFERIORITY|The margin of non-inferiority is 0.5. The true difference between the means is assumed to be -0.2. The significance level (alpha) of the test is 0.05. The data are drawn from populations with standard deviations of 0.7 and 0.3 (PASS 15 Power Analysis and Sample Size Software (2017). NCSS, LLC. Kaysville, Utah, USA, ncss.com/software/pass).||||||0.271|||||||Wilcoxon (Mann-Whitney)|||||||.271
72572393|NCT03801265|144672227|NON_INFERIORITY|The margin of non-inferiority is 0.5. The true difference between the means is assumed to be -0.2. The significance level (alpha) of the test is 0.05. The data are drawn from populations with standard deviations of 0.7 and 0.3 (PASS 15 Power Analysis and Sample Size Software (2017). NCSS, LLC. Kaysville, Utah, USA, ncss.com/software/pass).||||||0.81|||||||Wilcoxon (Mann-Whitney)|||||||.810
72572394|NCT03801265|144672228|NON_INFERIORITY|The margin of non-inferiority is 0.5. The true difference between the means is assumed to be -0.2. The significance level (alpha) of the test is 0.05. The data are drawn from populations with standard deviations of 0.7 and 0.3 (PASS 15 Power Analysis and Sample Size Software (2017). NCSS, LLC. Kaysville, Utah, USA, ncss.com/software/pass).||||||0.676|||||||Wilcoxon (Mann-Whitney)|||||||.676
72572395|NCT03801265|144672229|NON_INFERIORITY|The margin of non-inferiority is 0.5. The true difference between the means is assumed to be -0.2. The significance level (alpha) of the test is 0.05. The data are drawn from populations with standard deviations of 0.7 and 0.3 (PASS 15 Power Analysis and Sample Size Software (2017). NCSS, LLC. Kaysville, Utah, USA, ncss.com/software/pass).||||||0.908|||||||Wilcoxon (Mann-Whitney)|||||||.908
72533346|NCT03781167|144595858|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 26 vs Baseline||||<0.001
72572396|NCT03801265|144672230|NON_INFERIORITY|The margin of non-inferiority is 0.5. The true difference between the means is assumed to be -0.2. The significance level (alpha) of the test is 0.05. The data are drawn from populations with standard deviations of 0.7 and 0.3 (PASS 15 Power Analysis and Sample Size Software (2017). NCSS, LLC. Kaysville, Utah, USA, ncss.com/software/pass).||||||0.27|||||||Wilcoxon (Mann-Whitney)|||||||.270
72408012|NCT03238911|144324424|SUPERIORITY||Mean Difference (Final Values)|36.06|||<|0.0001|TWO_SIDED|95.0|27.33|44.78|||Mixed model for repeated measures|||"Day 35~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||44.78|27.33|<0.0001
72408013|NCT03238911|144324426|SUPERIORITY||Mean Difference (Final Values)|-105.74|||<|0.0001|TWO_SIDED|95.0|-131.04|-80.45|||Mixed model for repeated measures|||"Day 1~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||-80.45|-131.04|<0.0001
72408014|NCT03238911|144324426|SUPERIORITY||Mean Difference (Final Values)|-60.76|||<|0.0001|TWO_SIDED|95.0|-82.95|-38.58|||Mixed model for repeated measures|||"Day 7~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||-38.58|-82.95|<0.0001
72408015|NCT03238911|144324426|SUPERIORITY||Mean Difference (Final Values)|-293.23|||<|0.0001|TWO_SIDED|95.0|-368.15|-218.3|||Mixed model for repeated measures|||"Day 8~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||-218.30|-368.15|<0.0001
72408016|NCT03238911|144324426|SUPERIORITY||Mean Difference (Final Values)|-117.47|||<|0.0001|TWO_SIDED|95.0|-151.6|-83.33|||Mixed model for repeated measures|||"Day 14~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||-83.33|-151.60|<0.0001
72533347|NCT03781167|144595858|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 26 vs Baseline||||<0.001
72533348|NCT03781167|144595858|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 39 vs Baseline||||<0.001
72533349|NCT03781167|144595858|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 39 vs Baseline||||<0.001
72533350|NCT03781167|144595858|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 39 vs Baseline||||<0.001
72572397|NCT03801265|144672231|NON_INFERIORITY|The margin of non-inferiority is 0.5. The true difference between the means is assumed to be -0.2. The significance level (alpha) of the test is 0.05. The data are drawn from populations with standard deviations of 0.7 and 0.3 (PASS 15 Power Analysis and Sample Size Software (2017). NCSS, LLC. Kaysville, Utah, USA, ncss.com/software/pass).||||||0.015|||||||Wilcoxon (Mann-Whitney)|||||||.015
72572398|NCT03801265|144672232|NON_INFERIORITY|The margin of non-inferiority is 0.5. The true difference between the means is assumed to be -0.2. The significance level (alpha) of the test is 0.05. The data are drawn from populations with standard deviations of 0.7 and 0.3 (PASS 15 Power Analysis and Sample Size Software (2017). NCSS, LLC. Kaysville, Utah, USA, ncss.com/software/pass).||||||0.203|||||||Wilcoxon (Mann-Whitney)|||||||.203
72408017|NCT03238911|144324426|SUPERIORITY||Mean Difference (Final Values)|-71.21|||<|0.0001|TWO_SIDED|95.0|-101.8|-40.61|||Mixed model for repeated measures|||"Day 21~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||-40.61|-101.80|<0.0001
72533351|NCT03781167|144595858|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 52 vs Baseline||||<0.001
72533352|NCT03781167|144595858|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 52 vs Baseline||||<0.001
72533353|NCT03781167|144595858|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 52 vs Baseline||||<0.001
72533354|NCT03781167|144595859|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 6 vs Baseline||||<0.001
72533355|NCT03781167|144595859|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 6 vs Baseline||||<0.001
72533356|NCT03781167|144595859|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 6 vs Baseline||||<0.001
72533357|NCT03781167|144595859|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 13 vs Baseline||||<0.001
72533358|NCT03781167|144595859|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 13 vs Baseline||||<0.001
72533359|NCT03781167|144595859|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 13 vs Baseline||||<0.001
72533360|NCT03781167|144595859|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 26 vs Baseline||||<0.001
72533361|NCT03781167|144595859|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 26 vs Baseline||||<0.001
72533362|NCT03781167|144595859|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 26 vs Baseline||||<0.001
72408018|NCT03238911|144324426|SUPERIORITY||Mean Difference (Final Values)|-37.16|||<|0.0001|TWO_SIDED|95.0|-54.92|-19.39|||Mixed model for repeated measures|||"Day 35~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||-19.39|-54.92|<0.0001
72408019|NCT03238911|144324427|SUPERIORITY||Mean Difference (Final Values)|-99.1|||<|0.0001|TWO_SIDED|95.0|-136.42|-61.76|||Mixed model for repeated measures|||"Day 1~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||-61.76|-136.42|<0.0001
72408020|NCT03238911|144324427|SUPERIORITY||Mean Difference (Final Values)|-49.3|||<|0.0001|TWO_SIDED|95.0|-72.8|-25.9|||Mixed model for repeated measures|||"Day 7~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||-25.90|-72.80|<0.0001
72408021|NCT03238911|144324427|SUPERIORITY||Mean Difference (Final Values)|-191.3|||<|0.0001|TWO_SIDED|95.0|-242.47|-140.09|||Mixed model for repeated measures|||"Day 8~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||-140.09|-242.47|<0.0001
72408022|NCT03238911|144324427|SUPERIORITY||Mean Difference (Final Values)|-100.7|||<|0.0001|TWO_SIDED|95.0|-137.19|-64.2|||Mixed model for repeated measures|||"Day 14~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||-64.20|-137.19|<0.0001
72533363|NCT03781167|144595859|OTHER|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 39 vs Baseline||||<0.001
72533364|NCT03781167|144595859|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 39 vs Baseline||||<0.001
72533365|NCT03781167|144595859|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 39 vs Baseline||||<0.001
72533366|NCT03781167|144595859|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 52 vs Baseline||||<0.001
72533367|NCT03781167|144595859|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 52 vs Baseline||||<0.001
72626291|NCT00402987|144781746|SUPERIORITY_OR_OTHER_LEGACY|||||||0.164||95.0||||"Analysis at 4 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.164
72408023|NCT03238911|144324427|SUPERIORITY||Mean Difference (Final Values)|-48.4|||<|0.0001|TWO_SIDED|95.0|-71.78|-24.96|||Mixed model for repeated measures|||"Day 21~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||-24.96|-71.78|<0.0001
72533368|NCT03781167|144595859|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 52 vs Baseline||||<0.001
72533369|NCT03781167|144595860|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 6 vs Baseline||||<0.001
72533370|NCT03781167|144595860|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 6 vs Baseline||||<0.001
72533371|NCT03781167|144595860|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 6 vs Baseline||||<0.001
72533372|NCT03781167|144595860|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 13 vs Baseline||||<0.001
72533373|NCT03781167|144595860|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 13 vs Baseline||||<0.001
72533374|NCT03781167|144595860|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 13 vs Baseline||||<0.001
72533375|NCT03781167|144595860|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 26 vs Baseline||||<0.001
72533376|NCT03781167|144595860|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 26 vs Baseline||||<0.001
72533377|NCT03781167|144595860|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 26 vs Baseline||||<0.001
72533378|NCT03781167|144595860|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 39 vs Baseline||||<0.001
72533379|NCT03781167|144595860|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 39 vs Baseline||||<0.001
72533380|NCT03781167|144595860|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 39 vs Baseline||||<0.001
72533381|NCT03781167|144595860|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 52 vs Baseline||||<0.001
72533382|NCT03781167|144595860|OTHER|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 52 vs Baseline||||<0.001
72533383|NCT03781167|144595860|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 52 vs Baseline||||<0.001
72533384|NCT03781167|144595861|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.0035|||||||paired-sample t-test|||Week 6 vs Baseline||||=0.0035
72533385|NCT03781167|144595861|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 6 vs Baseline||||<0.001
72533386|NCT03781167|144595861|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 6 vs Baseline||||<0.001
72533387|NCT03781167|144595861|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.0098|||||||paired-sample t-test|||Week 13 vs Baseline||||=0.0098
72533388|NCT03781167|144595861|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 13 vs Baseline||||<0.001
72533389|NCT03781167|144595861|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 13 vs Baseline||||<0.001
72626292|NCT00402987|144781746|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||Analysis at 5 hours Pairwise comparison. No adjustment made for multiplicity.|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
72626293|NCT00402987|144781746|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 5 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
72626294|NCT00402987|144781746|SUPERIORITY_OR_OTHER_LEGACY|||||||0.244||95.0||||"Analysis at 5 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.244
72626295|NCT00402987|144781746|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 6 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
72626296|NCT00402987|144781746|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 6 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
72533390|NCT03781167|144595861|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 26 vs Baseline||||<0.001
72533391|NCT03781167|144595861|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 26 vs Baseline||||<0.001
72533392|NCT03781167|144595861|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 26 vs Baseline||||<0.001
72533393|NCT03781167|144595861|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 39 vs Baseline||||<0.001
72533394|NCT03781167|144595861|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 39 vs Baseline||||<0.001
72533395|NCT03781167|144595861|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 39 vs Baseline||||<0.001
72533396|NCT03781167|144595861|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.003|||||||paired-sample t-test|||Week 52 vs Baseline||||=0.0030
72533397|NCT03781167|144595861|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 52 vs Baseline||||<0.001
72533398|NCT03781167|144595861|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 52 vs Baseline||||<0.001
72533399|NCT00398476|144595891|OTHER|||||||0.003|||||||Cochran-Mantel-Haenszel|||Analysis for overall product preference||||0.003
72533400|NCT00398476|144595891|OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||Analysis for Scent/odor||||<0.001
72533401|NCT00398476|144595891|OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||Analysis for Immediate taste||||<0.001
72533402|NCT00398476|144595891|OTHER|||||||0.002|||||||Cochran-Mantel-Haenszel|||Analysis for After-taste||||0.002
72533403|NCT00398476|144595891|OTHER|||||||0.037|||||||Cochran-Mantel-Haenszel|||Analysis for Less drip down throat||||0.037
72533404|NCT00398476|144595891|OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||Analysis for Less run out nose||||<0.001
72533405|NCT00398476|144595891|OTHER|||||||0.408|||||||Cochran-Mantel-Haenszel|||Analysis for More soothing||||0.408
72533406|NCT00398476|144595891|OTHER|||||||0.07|||||||Cochran-Mantel-Haenszel|||Analysis for Less irritating||||0.070
72533407|NCT00398476|144595891|OTHER|||||||0.587|||||||Cochran-Mantel-Haenszel|||Analysis for Urge to sneeze||||0.587
72533408|NCT00398476|144595892|EQUIVALENCE|Assuming that 65% of participants indicate an overall preference for FF over FP, then a sample size of 125 participants will provide 93% power to show that difference in proportions (i.e., 65% favoring FF vs 35% favoring FP)|Median Difference (Final Values)|-2.0|||<|0.001||95.0|||||Cochran-Mantel-Haenszel|||Comparison of FF 110 µg and FP 200 µg for IAQ items||||<0.001
72533409|NCT00398476|144595892|EQUIVALENCE|Assuming that 65% of participants indicate an overall preference for FF over FP, then a sample size of 125 participants will provide 93% power to show that difference in proportions (i.e., 65% favoring FF vs 35% favoring FP)|Median Difference (Final Values)|-1.0|||<|0.001||95.0|||||Cochran-Mantel-Haenszel|||Comparison of FF 110 µg and FP 200 µg for DAQ items||||<0.001
72626297|NCT00402987|144781746|SUPERIORITY_OR_OTHER_LEGACY|||||||0.336||95.0||||"Analysis at 6 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.336
72626298|NCT00402987|144781747|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 7 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
72533410|NCT00398476|144595893|EQUIVALENCE|Assuming that 65% of participants indicate an overall preference for FF over FP, then a sample size of 125 participants will provide 93% power to show that difference in proportions (i.e., 65% favoring FF vs 35% favoring FP)|Median Difference (Net)|0.0||||0.255||95.0|||||Cochran-Mantel-Haenszel|||Comparison of FF 110 µg and FP 200 µg in IAQ||||0.255
72533411|NCT00398476|144595894|EQUIVALENCE|Assuming that 65% of participants indicate an overall preference for FF over FP, then a sample size of 125 participants will provide 93% power to show that difference in proportions (i.e., 65% favoring FF vs 35% favoring FP)|Median Difference (Net)|0.0||||0.056||95.0|||||Cochran-Mantel-Haenszel|||Comparison of FF 110 µg and FP 200 µg for all DAQ items||||0.056
72533412|NCT00398476|144595895|EQUIVALENCE|Assuming that 65% of participants indicate an overall preference for FF over FP, then a sample size of 125 participants will provide 93% power to show that difference in proportions (i.e., 65% favoring FF vs 35% favoring FP).|Median Difference (Net)|0.0||||0.845||95.0|||||Cochran-Mantel-Haenszel|||Comparison of FF 110 µg and FP 200 µg for IAQ Irtems||||0.845
72533413|NCT00398476|144595896|EQUIVALENCE|Assuming that 65% of participants indicate an overall preference for FF over FP, then a sample size of 125 participants will provide 93% power to show that difference in proportions (i.e., 65% favoring FF vs 35% favoring FP).|Median Difference (Net)|0.0||||0.871||95.0|||||Cochran-Mantel-Haenszel|||Comparison of FF 110 µg and FP 200 µg for DAQ Items||||0.871
72533414|NCT00398476|144595897|EQUIVALENCE|Assuming that 65% of participants indicate an overall preference for FF over FP, then a sample size of 125 participants will provide 93% power to show that difference in proportions (i.e., 65% favoring FF vs 35% favoring FP).|Median Difference (Net)|0.0|||<|0.001||95.0|||||Cochran-Mantel-Haenszel|||||||<0.001
72533415|NCT00398476|144595898|EQUIVALENCE|Assuming that 65% of participants indicate an overall preference for FF over FP, then a sample size of 125 participants will provide 93% power to show that difference in proportions (i.e., 65% favoring FF vs 35% favoring FP).|Median Difference (Net)|0.0||||0.592||95.0|||||Cochran-Mantel-Haenszel|||||||0.592
72533416|NCT00398476|144595899|EQUIVALENCE|Assuming that 65% of participants indicate an overall preference for FF over FP, then a sample size of 125 participants will provide 93% power to show that difference in proportions (i.e., 65% favoring FF vs 35% favoring FP)|Median Difference (Net)|0.0|||<|0.001||95.0|||||Cochran-Mantel-Haenszel|||||||<0.001
72533417|NCT00398476|144595900|EQUIVALENCE|Assuming that 65% of participants indicate an overall preference for FF over FP, then a sample size of 125 participants will provide 93% power to show that difference in proportions (i.e., 65% favoring FF vs 35% favoring FP).|Median Difference (Net)|0.0||||0.434||95.0|||||Cochran-Mantel-Haenszel|||||||0.434
72533418|NCT00398476|144595901|EQUIVALENCE|Assuming that 65% of participants indicate an overall preference for FF over FP, then a sample size of 125 participants will provide 93% power to show that difference in proportions (i.e., 65% favoring FF vs 35% favoring FP).|Median Difference (Net)|0.0||||0.797|||||||Cochran-Mantel-Haenszel|||This analysis is for IAQ||||0.797
72533419|NCT00398476|144595901|EQUIVALENCE|Assuming that 65% of participants indicate an overall preference for FF over FP, then a sample size of 125 participants will provide 93% power to show that difference in proportions (i.e., 65% favoring FF vs 35% favoring FP).|Median Difference (Net)|0.0||||0.296|||||||Cochran-Mantel-Haenszel|||This analysis is for DAQ||||0.296
72572399|NCT03801265|144672233|NON_INFERIORITY|The margin of non-inferiority is 0.5. The true difference between the means is assumed to be -0.2. The significance level (alpha) of the test is 0.05. The data are drawn from populations with standard deviations of 0.7 and 0.3 (PASS 15 Power Analysis and Sample Size Software (2017). NCSS, LLC. Kaysville, Utah, USA, ncss.com/software/pass).||||||0.672|||||||Wilcoxon (Mann-Whitney)|||||||.672
72572400|NCT04078126|144672234|OTHER||Mean Difference (Final Values)|-0.017|STANDARD_ERROR_OF_MEAN|0.0179||0.345|TWO_SIDED|95.0|-0.054|0.02|||ANCOVA|||||0.020|-0.054|0.3450
72533420|NCT00398476|144595902|EQUIVALENCE|Assuming that 65% of participants indicate an overall preference for FF over FP, then a sample size of 125 participants will provide 93% power to show that difference in proportions (i.e., 65% favoring FF vs 35% favoring FP).|Median Difference (Net)|0.0|||<|0.001|||||||Cochran-Mantel-Haenszel|||Comparison of FF 110 µg and FP 200 µg in IAQ||||<0.001
72533421|NCT00398476|144595902|EQUIVALENCE|Assuming that 65% of participants indicate an overall preference for FF over FP, then a sample size of 125 participants will provide 93% power to show that difference in proportions (i.e., 65% favoring FF vs 35% favoring FP).|Median Difference (Net)|0.0|||<|0.001|||||||Cochran-Mantel-Haenszel|||Comparison of FF 110 µg and FP 200 µg in DAQ||||<0.001
72533422|NCT00398476|144595903|EQUIVALENCE|Assuming that 65% of participants indicate an overall preference for FF over FP, then a sample size of 125 participants will provide 93% power to show that difference in proportions (i.e., 65% favoring FF vs 35% favoring FP).|Median Difference (Net)|0.0||||0.968|||||||Cochran-Mantel-Haenszel|||This analysis is for IAQ||||0.968
72533423|NCT00398476|144595903|EQUIVALENCE|Assuming that 65% of participants indicate an overall preference for FF over FP, then a sample size of 125 participants will provide 93% power to show that difference in proportions (i.e., 65% favoring FF vs 35% favoring FP).|Mean Difference (Net)|0.0||||0.797|||||||Cochran-Mantel-Haenszel|||This analysis is for DAQ||||0.797
72533424|NCT00398476|144595904|EQUIVALENCE|Assuming that 65% of participants indicate an overall preference for FF over FP, then a sample size of 125 participants will provide 93% power to show that difference in proportions (i.e., 65% favoring FF vs 35% favoring FP).|Median Difference (Net)|0.0||||0.221|||||||Cochran-Mantel-Haenszel|||||||0.221
72533425|NCT00398476|144595905|EQUIVALENCE|Assuming that 65% of participants indicate an overall preference for FF over FP, then a sample size of 125 participants will provide 93% power to show that difference in proportions (i.e., 65% favoring FF vs 35% favoring FP).|Median Difference (Net)|0.0||||0.205|||||||Cochran-Mantel-Haenszel|||||||0.205
72533426|NCT00398476|144595906|EQUIVALENCE|Assuming that 65% of participants indicate an overall preference for FF over FP, then a sample size of 125 participants will provide 93% power to show that difference in proportions (i.e., 65% favoring FF vs 35% favoring FP)|Median Difference (Net)|0.0||||0.108|||||||Cochran-Mantel-Haenszel|||||||0.108
72533427|NCT00398476|144595907|EQUIVALENCE|Assuming that 65% of participants indicate an overall preference for FF over FP, then a sample size of 125 participants will provide 93% power to show that difference in proportions (i.e., 65% favoring FF vs 35% favoring FP).|Median Difference (Net)|0.0||||0.694|||||||Cochran-Mantel-Haenszel|||||||0.694
72572401|NCT04078126|144672235|OTHER||Mean Difference (Final Values)|-0.017|STANDARD_ERROR_OF_MEAN|0.0183||0.3675|TWO_SIDED|95.0|-0.054|0.021|||ANCOVA|||||0.021|-0.054|0.3675
72533428|NCT00398476|144595908|EQUIVALENCE|Assuming that 65% of participants indicate an overall preference for FF over FP, then a sample size of 125 participants will provide 93% power to show that difference in proportions (i.e., 65% favoring FF vs 35% favoring FP).|Median Difference (Net)|0.0||||0.02|||||||Cochran-Mantel-Haenszel|||||||0.020
72533429|NCT04278846|144595968|SUPERIORITY|||||||0.87|||||||Kruskal-Wallis|||||||.87
72533430|NCT04278846|144595969|SUPERIORITY|||||||0.49|||||||Kruskal-Wallis|||||||.49
72572402|NCT04078126|144672236|OTHER||Mean Difference (Final Values)|-0.006|STANDARD_ERROR_OF_MEAN|0.0199||0.7563|TWO_SIDED|95.0|-0.047|0.034|||ANCOVA|||||0.034|-0.047|0.7563
72572403|NCT04078126|144672237|OTHER||Mean Difference (Final Values)|-0.032|STANDARD_ERROR_OF_MEAN|0.0521||0.5419|TWO_SIDED|95.0|-0.139|0.075|||ANCOVA|||||0.075|-0.139|0.5419
72572404|NCT04078126|144672238|OTHER||Mean Difference (Final Values)|-3.6|STANDARD_ERROR_OF_MEAN|2.334||0.1337|TWO_SIDED|95.0|-8.39|1.18|||ANCOVA|||||1.18|-8.39|0.1337
72572405|NCT04078126|144672239|OTHER||Mean Difference (Final Values)|-2.69|STANDARD_ERROR_OF_MEAN|1.269||0.0431|TWO_SIDED|95.0|-5.29|-0.09|||ANCOVA|||||-0.09|-5.29|0.0431
72572406|NCT04078126|144672240|OTHER||Mean Difference (Final Values)|-1.53|STANDARD_ERROR_OF_MEAN|1.667||0.3625|TWO_SIDED|95.0|-4.87|1.81|||ANCOVA|||||1.81|-4.87|0.3625
72572407|NCT04078126|144672241|OTHER||Mean Difference (Final Values)|0.043|STANDARD_ERROR_OF_MEAN|0.0198||0.0375|TWO_SIDED|95.0|0.003|0.084|||ANCOVA|||||0.084|0.003|0.0375
72626299|NCT00402987|144781747|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 7 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
72533431|NCT04278846|144595970|SUPERIORITY|||||||0.57|||||||Kruskal-Wallis|||||||.57
72533432|NCT04278846|144595971|SUPERIORITY|||||||0.3|||||||Kruskal-Wallis|||||||.3
72572408|NCT04078126|144672242|OTHER||Mean Difference (Final Values)|0.005|STANDARD_ERROR_OF_MEAN|0.0443||0.9089|TWO_SIDED|95.0|-0.086|0.096|||ANCOVA|||||0.096|-0.086|0.9089
72533433|NCT04278846|144595972|SUPERIORITY|||||||0.99|||||||Kruskal-Wallis|||||||.99
72533434|NCT04278846|144595973|SUPERIORITY|||||||0.33|||||||Kruskal-Wallis|||||||.33
72533435|NCT04278846|144595974|SUPERIORITY|||||||0.26|||||||Kruskal-Wallis|||||||.26
72533436|NCT04278846|144595975|SUPERIORITY|||||||0.79|||||||Kruskal-Wallis|||||||.79
72533437|NCT04278846|144595976|SUPERIORITY|||||||0.62|||||||Kruskal-Wallis|||||||.62
72572409|NCT02605993|144672251|OTHER||||||<|0.0001|TWO_SIDED|95.0||||Hypothesis testing was performed at the 0.05 level of significance. P-value tested whether the percent changes differed from 0 for the combined cohorts.|Mixed Model for Repeated Measures (MMRM)|||Statistical Analysis presented is of Cohorts 1 to 4 combined at Day 253. A sample size of 20 participants from the combined cohorts was required to provide approximately 95% power to detect a mean paired difference in LDH from Baseline of -40% at Day 253 for Cohorts 1 to 4, with an estimated standard deviation (SD) of 45%. This was based on a 2-sided paired t-test, with 5% type I error rate. To account for a possible 15% dropout rate, up to 26 participants were enrolled.||||<0.0001
72626300|NCT00402987|144781747|SUPERIORITY_OR_OTHER_LEGACY|||||||0.09||95.0||||"Analysis at 7 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.090
72626301|NCT00402987|144781747|SUPERIORITY_OR_OTHER_LEGACY|||||||0.518||95.0||||"Analysis at 7 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.518
72533438|NCT04278846|144595977|SUPERIORITY|||||||0.94|||||||Kruskal-Wallis|||||||.94
72533439|NCT04278846|144595978|SUPERIORITY|||||||0.95|||||||Kruskal-Wallis|||||||.95
72533440|NCT04278846|144595979|SUPERIORITY|||||||0.54|||||||Kruskal-Wallis|||||||.54
72533441|NCT04278846|144595980|SUPERIORITY|||||||0.95|||||||Kruskal-Wallis|||||||.95
72533442|NCT04278846|144595981|SUPERIORITY|||||||0.96|||||||Kruskal-Wallis|||||||.96
72533443|NCT04278846|144595983|SUPERIORITY|||||||0.088|||||||Kruskal-Wallis|||||||.088
72533444|NCT04278846|144595984|SUPERIORITY|||||||0.42|||||||Kruskal-Wallis|||||||.42
72533445|NCT04278846|144595985|SUPERIORITY|||||||0.88|||||||Kruskal-Wallis|||||||.88
72533446|NCT04278846|144595987|SUPERIORITY|||||||0.12|||||||Kruskal-Wallis|||||||.12
72533447|NCT04278846|144595988|SUPERIORITY|||||||0.96|||||||t-test, 2 sided|||||||.96
72533448|NCT04278846|144595989|SUPERIORITY|||||||0.76|||||||t-test, 2 sided|||||||.76
72533449|NCT04278846|144595990|SUPERIORITY|||||||0.88|||||||t-test, 2 sided|||||||.88
72533450|NCT04278846|144595991|SUPERIORITY|||||||0.37|||||||t-test, 2 sided|||||||.37
72533451|NCT01539512|144596000|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.18|||<|0.0001|TWO_SIDED|95.0|0.1|0.32|||Log Rank|P-value is from stratified log-rank test, adjusted for randomization stratification factors.||||0.32|0.10|< 0.0001
72533452|NCT01539512|144596003|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.28|||||TWO_SIDED|95.0|0.11|0.69||||||||0.69|0.11|
72533453|NCT01333501|144596035|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.86|STANDARD_ERROR_OF_MEAN|2.7||0.494|TWO_SIDED|95.0|-3.51|7.23|||ANCOVA|||||7.23|-3.51|0.4940
72572410|NCT02605993|144672251|OTHER||||||<|0.0001|TWO_SIDED|95.0||||Hypothesis testing was performed at the 0.05 level of significance. P-value tested whether the percent changes differed from 0.|MMRM|||Statistical Analysis presented is of Cohort 4 at Day 281. A sample size of 20 participants from the combined cohorts was required to provide approximately 95% power to detect a mean paired difference in LDH from Baseline of -40% at Day 281 for Cohort 4 only, with an estimated SD of 45%. This was based on a 2-sided paired t-test, with 5% type I error rate. To account for a possible 15% dropout rate, up to 26 participants were enrolled.||||<0.0001
72572411|NCT02605993|144672252|OTHER|||||||0.0214||||||Hypothesis testing was performed at the 0.05 level of significance. P-value tested whether the percent changes differed from 0 for the combined cohorts.|MMRM|||Statistical Analysis presented is of Cohorts 1 to 4 combined at Day 253.||||0.0214
72572412|NCT02605993|144672252|OTHER|||||||0.0313||||||Hypothesis testing was performed at the 0.05 level of significance. P-value tested whether the percent changes differed from 0.|MMRM|||Statistical Analysis presented is of Cohort 4 at Day 281.||||0.0313
72572413|NCT02605993|144672253|OTHER|||||||0.0625||||||Hypothesis testing was performed at the 0.05 level of significance. P-value tested whether the percent changes differed from 0 for the combined cohorts.|MMRM|||tatistical Analysis presented is of Cohorts 1 to 4 combined at Day 253.||||0.0625
72408024|NCT03238911|144324427|SUPERIORITY||Mean Difference (Final Values)|-15.0||||0.1411|TWO_SIDED|95.0|-35.04|5.06|||Mixed model for repeated measures|||"Day 35~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||5.06|-35.04|0.1411
72533454|NCT01333501|144596036|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.97|STANDARD_ERROR_OF_MEAN|3.03||0.5183|TWO_SIDED|95.0|-4.06|7.99|||ANCOVA|||||7.99|-4.06|0.5183
72533455|NCT01333501|144596037|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.6|STANDARD_ERROR_OF_MEAN|1.05||0.1334|TWO_SIDED|95.0|-3.69|0.5|||ANCOVA|||||0.50|-3.69|0.1334
72533456|NCT01333501|144596038|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.73|STANDARD_ERROR_OF_MEAN|2.29||0.4501|TWO_SIDED|95.0|-6.27|2.81|||ANCOVA|||||2.81|-6.27|0.4501
72533457|NCT01333501|144596039|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.46|STANDARD_ERROR_OF_MEAN|2.53||0.8561|TWO_SIDED|95.0|-4.57|5.49|||ANCOVA|||||5.49|-4.57|0.8561
72572414|NCT02605993|144672253|OTHER|MMRM||||||0.5||||||Hypothesis testing was performed at the 0.05 level of significance. P-value tested whether the percent changes differed from 0.|MMRM|||Hypothesis testing was performed at the 0.05 level of significance. P-value tested whether the percent changes differed from 0 for the combined cohorts.||||0.5000
72408025|NCT03238911|144324428|SUPERIORITY||Mean Difference (Final Values)|-0.24||||0.562|TWO_SIDED|95.0|-1.08|0.59|||Mixed model for repeated measures|||"Day 1~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||0.59|-1.08|0.5620
72533458|NCT01333501|144596040|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.37|STANDARD_ERROR_OF_MEAN|2.53||0.8858|TWO_SIDED|95.0|-4.67|5.4|||ANCOVA|||||5.40|-4.67|0.8858
72533459|NCT01333501|144596041|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.17|STANDARD_ERROR_OF_MEAN|0.47||0.7119|TWO_SIDED|95.0|-0.76|1.11|||ANCOVA|||||1.11|-0.76|0.7119
72533460|NCT01333501|144596042|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.03|STANDARD_ERROR_OF_MEAN|0.42||0.9496|TWO_SIDED|95.0|-0.86|0.81|||ANCOVA|||||0.81|-0.86|0.9496
72533461|NCT01333501|144596043|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.16|STANDARD_ERROR_OF_MEAN|1.18||0.8944|TWO_SIDED|95.0|-2.18|2.5|||ANCOVA|||||2.50|-2.18|0.8944
72533462|NCT01333501|144596044|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.25|STANDARD_ERROR_OF_MEAN|0.59||0.6757|TWO_SIDED|95.0|-1.42|0.92|||ANCOVA|||||0.92|-1.42|0.6757
72533463|NCT01333501|144596045|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.16|STANDARD_ERROR_OF_MEAN|2.34||0.3585|TWO_SIDED|95.0|-6.82|2.5|||ANCOVA|||||2.50|-6.82|0.3585
72533464|NCT01333501|144596046|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.24|STANDARD_ERROR_OF_MEAN|3.69||0.161|TWO_SIDED|95.0|-12.62|2.14|||ANCOVA|||||2.14|-12.62|0.1610
72533465|NCT00674440|144596056|OTHER||Sensitivity|93.0|||||TWO_SIDED|95.0|80.9|98.5||||||||98.5|80.9|
72533466|NCT00674440|144596056|OTHER||Specifity|88.5|||||TWO_SIDED|95.0|76.6|95.6||||||||95.6|76.6|
72533467|NCT01728194|144596092|OTHER||||||<|0.025|||||||Mixed Models Analysis|||||||< 0.025
72533468|NCT01728194|144596093|OTHER||||||<|0.025|||||||Mixed Models Analysis|||||||<0.025
72533469|NCT02129192|144596114|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was established by using the average bioequivalence method and by ensuring that the ratio of Cmax of the two treatments was within the pre-specified acceptance range (80%-125%)|Adjusted geometric mean ratio (%)|95.77|||||TWO_SIDED|90.0|88.89|103.17|||Mixed Models Analysis|"Model on logarithmic scale included subjects within sequence as random effect and sequence, period, and treatment as fixed effects."|Ratio calculated as T80/A5/H12.5 mg FDC divided by T80/H12.5 FDC + A5 mono.|Adjusted by-treatment means on the log-transformed scale for telmisartan 80 mg||103.17|88.89|
72533470|NCT02129192|144596114|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was established by using the average bioequivalence method and by ensuring that the ratio of Cmax of the two treatments was within the pre-specified acceptance range (80%-125%)|Adjusted geometric mean ratio (%)|101.4|||||TWO_SIDED|90.0|99.7|103.13|||Mixed Models Analysis|"Model on logarithmic scale included subjects within sequence as random effect and sequence, period, and treatment as fixed effects."|Ratio calculated as T80/A5/H12.5 mg FDC divided by T80/H12.5 FDC + A5 mono.|Adjusted by-treatment means on the log-transformed scale for amlodipine 5 mg||103.13|99.70|
72533471|NCT02129192|144596114|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was established by using the average bioequivalence method and by ensuring that the ratio of Cmax of the two treatments was within the pre-specified acceptance range (80%-125%)|Adjusted geometric mean ratio (%)|101.77|||||TWO_SIDED|90.0|98.46|105.19|||Mixed Models Analysis|"Model on logarithmic scale included subjects within sequence as random effect and sequence, period, and treatment as fixed effects."|Ratio calculated as T80/A5/H12.5 mg FDC divided by T80/H12.5 FDC + A5 mono.|Adjusted by-treatment means on the log-transformed scale for hydrochlorothiazide 12.5 mg||105.19|98.46|
72533472|NCT02129192|144596115|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio (%)|30.15||||1|TWO_SIDED|90.0|24.99|36.38|||ANOVA|"Model included subject as random effect and feeding condition as fixed effect."|Ratio calculated as T80/A5/H12.5 mg FDC Fed divided by T80/A5/H12.5 mg FDC Fasted.|Adjusted by-treatment geometric means for telmisartan 80 mg. No hypothesis was tested.||36.38|24.99|1.0000
72533473|NCT02129192|144596115|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio (%)|98.23|||<|0.0001|TWO_SIDED|90.0|94.63|101.97|||ANOVA|"Model included subject as random effect and feeding condition as fixed effect."|Ratio calculated as T80/A5/H12.5 mg FDC Fed divided by T80/A5/H12.5 mg FDC Fasted.|Adjusted by-treatment geometric means for amlodipine 5 mg. No hypothesis was tested.||101.97|94.63|<0.0001
72572415|NCT02605993|144672254|OTHER|||||||0.4871||||||Hypothesis testing was performed at the 0.05 level of significance. P-value tested whether the percent changes differed from 0 for the combined cohorts.|MMRM|||Statistical Analysis presented is of Cohorts 1 to 4 combined at Day 253.||||0.4871
72572416|NCT02605993|144672254|OTHER|||||||0.4688||||||Hypothesis testing was performed at the 0.05 level of significance. P-value tested whether the percent changes differed from 0.|MMRM|||Statistical Analysis presented is of Cohort 4 at Day 281.||||0.4688
72408026|NCT03238911|144324428|SUPERIORITY||Mean Difference (Final Values)|1.75||||0.0126|TWO_SIDED|95.0|0.38|3.12|||Mixed model for repeated measures|||"Day 7~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||3.12|0.38|0.0126
72408027|NCT03238911|144324428|SUPERIORITY||Mean Difference (Final Values)|0.42||||0.608|TWO_SIDED|95.0|-1.19|2.02|||Mixed model for repeated measures|||"Day 8~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||2.02|-1.19|0.6080
72408028|NCT03238911|144324428|SUPERIORITY||Mean Difference (Final Values)|2.09||||0.0379|TWO_SIDED|95.0|0.12|4.05|||Mixed model for repeated measures|||"Day 14~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||4.05|0.12|0.0379
72408029|NCT03238911|144324428|SUPERIORITY||Mean Difference (Final Values)|1.17||||0.2368|TWO_SIDED|95.0|-0.78|3.12|||Mixed model for repeated measures|||"Day 21~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||3.12|-0.78|0.2368
72533474|NCT02129192|144596115|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio (%)|79.69||||0.5422|TWO_SIDED|90.0|74.97|84.71|||ANOVA|"Model included subject as random effect and feeding condition as fixed effect."|Ratio calculated as T80/A5/H12.5 mg FDC Fed divided by T80/A5/H12.5 mg FDC Fasted.|Adjusted by-treatment geometric means for hydrochlorothiazide 12.5 mg. No hypothesis was tested.||84.71|74.97|0.5422
72533475|NCT02129192|144596116|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was established by using the average bioequivalence method and by ensuring that the ratio of AUC 0-tz of the two treatments was within the pre-specified acceptance range (80%-125%)|Adjusted geometric mean ratio (%)|99.21|||||TWO_SIDED|90.0|96.14|102.38|||Mixed Models Analysis|"Model on logarithmic scale included subjects within sequence as random effect and sequence, period, and treatment as fixed effects."|Ratio calculated as T80/A5/H12.5 mg FDC divided by T80/H12.5 FDC + A5 mono.|Adjusted by-treatment means on the log-transformed scale for telmisartan 80 mg||102.38|96.14|
72533476|NCT02129192|144596116|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was established by using the average bioequivalence method and by ensuring that the ratio of AUC 0-tz of the two treatments was within the pre-specified acceptance range (80%-125%)|Adjusted geometric mean ratio (%)|101.43||||||90.0|99.84|103.04|||Mixed Models Analysis|"Model on logarithmic scale included subjects within sequence as random effect and sequence, period, and treatment as fixed effects."|Ratio calculated as T80/A5/H12.5 mg FDC divided by T80/H12.5 FDC + A5 mono.|Adjusted by-treatment means on the log-transformed scale for amlodipine 5 mg||103.04|99.84|
72533477|NCT02129192|144596116|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was established by using the average bioequivalence method and by ensuring that the ratio of AUC 0-tz of the two treatments was within the pre-specified acceptance range (80%-125%)|Adjusted geometric mean ratio (%)|100.33|||||TWO_SIDED|90.0|98.29|102.4|||Mixed Models Analysis|"Model on logarithmic scale included subjects within sequence as random effect and sequence, period, and treatment as fixed effects."|Ratio calculated as T80/A5/H12.5 mg FDC divided by T80/H12.5 FDC + A5 mono.|Adjusted by-treatment means on the log-transformed scale for hydrochlorothiazide 12.5 mg||102.40|98.29|
72533478|NCT02129192|144596117|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio (%)|63.66||||1|TWO_SIDED|90.0|58.98|68.71|||ANOVA|"Model included subject as random effect and feeding condition as fixed effect."|Ratio calculated as T80/A5/H12.5 mg FDC Fed divided by T80/A5/H12.5 mg FDC Fasted.|Adjusted by-treatment geometric means for telmisartan 80 mg. No hypothesis was tested.||68.71|58.98|1.0000
72533479|NCT02129192|144596117|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio (%)|99.74|||<|0.0001|TWO_SIDED|90.0|97.08|102.48|||ANOVA|"Model included subject as random effect and feeding condition as fixed effect."|Ratio calculated as T80/A5/H12.5 mg FDC Fed divided by T80/A5/H12.5 mg FDC Fasted.|Adjusted by-treatment geometric means for amlodipine 5 mg. No hypothesis was tested.||102.48|97.08|<0.0001
72572417|NCT02605993|144672255|OTHER|||||||0.0023||||||Hypothesis testing was performed at the 0.05 level of significance. P-value tested whether the percent changes differed from 0 for the combined cohorts.|MMRM|||Statistical Analysis presented is of Cohorts 1 to 4 combined at Day 253.||||0.0023
72572418|NCT02605993|144672256|OTHER|||||||0.0029||||||Hypothesis testing was performed at the 0.05 level of significance. P-value tested whether the percent changes differed from 0 for the combined cohorts.|MMRM|||Statistical Analysis presented is of Cohorts 1 to 4 combined at Day 253.||||0.0029
72408030|NCT03238911|144324428|SUPERIORITY||Mean Difference (Final Values)|-0.22||||0.8287|TWO_SIDED|95.0|-2.18|1.75|||Mixed model for repeated measures|||"Day 35~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||1.75|-2.18|0.8287
72408031|NCT03238911|144324429|SUPERIORITY||Mean Difference (Final Values)|24.27|||<|0.0001|TWO_SIDED|95.0|18.81|29.73|||Mixed model for repeated measures|||"Day 1~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||29.73|18.81|<0.0001
72408032|NCT03238911|144324429|SUPERIORITY||Mean Difference (Final Values)|15.75|||<|0.0001|TWO_SIDED|95.0|8.83|22.67|||Mixed model for repeated measures|||"Day 7~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||22.67|8.83|<0.0001
72408033|NCT03238911|144324429|SUPERIORITY||Mean Difference (Final Values)|20.14|||<|0.0001|TWO_SIDED|95.0|12.07|28.22|||Mixed model for repeated measures|||"Day 8~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||28.22|12.07|<0.0001
72408034|NCT03238911|144324429|SUPERIORITY||Mean Difference (Final Values)|32.22|||<|0.0001|TWO_SIDED|95.0|25.49|38.96|||Mixed model for repeated measures|||"Day 14~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||38.96|25.49|<0.0001
72408035|NCT03238911|144324429|SUPERIORITY||Mean Difference (Final Values)|22.87|||<|0.0001|TWO_SIDED|95.0|14.79|30.95|||Mixed model for repeated measures|||"Day 21~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||30.95|14.79|<0.0001
72408036|NCT03238911|144324429|SUPERIORITY||Mean Difference (Final Values)|10.6||||0.0043|TWO_SIDED|95.0|3.39|17.82|||Mixed model for repeated measures|||"Day 35~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||17.82|3.39|0.0043
72408037|NCT03238911|144324430|SUPERIORITY||Mean Difference (Final Values)|-0.17||||0.0552|TWO_SIDED|95.0|-0.34|0.0|||Mixed model for repeated measures|||"Day 1~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||0.00|-0.34|0.0552
72533480|NCT02129192|144596117|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio (%)|89.66||||0.0001|TWO_SIDED|90.0|85.8|93.7|||ANOVA|"Model included subject as random effect and feeding condition as fixed effect."|Ratio calculated as T80/A5/H12.5 mg FDC Fed divided by T80/A5/H12.5 mg FDC Fasted.|Adjusted by-treatment geometric means for hydrochlorothiazide 12.5 mg. No hypothesis was tested.||93.70|85.80|0.0001
72533481|NCT02129192|144596118|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was established by using the average bioequivalence method and by ensuring that the ratio of AUC 0-inf of the two treatments was within the pre-specified acceptance range (80%-125%).|Adjusted geometric mean ratio (%)|99.62|||||TWO_SIDED|90.0|96.32|103.04|||Mixed Models Analysis|"Model on logarithmic scale included subjects within sequence as random effect and sequence, period, and treatment as fixed effects."|Ratio calculated as T80/A5/H12.5 mg FDC divided by T80/H12.5 FDC + A5 mono.|Adjusted by-treatment means on the log-transformed scale for telmisartan 80 mg||103.04|96.32|
72533482|NCT02129192|144596118|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was established by using the average bioequivalence method and by ensuring that the ratio of AUC 0-inf of the two treatments was within the pre-specified acceptance range (80%-125%).|Adjusted geometric mean ratio (%)|101.21|||||TWO_SIDED|90.0|99.59|102.87|||Mixed Models Analysis|"Model on logarithmic scale included subjects within sequence as random effect and sequence, period, and treatment as fixed effects."|Ratio calculated as T80/A5/H12.5 mg FDC divided by T80/H12.5 FDC + A5 mono.|Adjusted by-treatment means on the log-transformed scale for amlodipine 5 mg||102.87|99.59|
72408038|NCT03238911|144324430|SUPERIORITY||Mean Difference (Final Values)|-0.37||||0.0023|TWO_SIDED|95.0|-0.6|-0.13|||Mixed model for repeated measures|||"Day 7~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||-0.13|-0.60|0.0023
72533483|NCT02129192|144596118|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was established by using the average bioequivalence method and by ensuring that the ratio of AUC 0-inf of the two treatments was within the pre-specified acceptance range (80%-125%).|Adjusted geometric mean ratio (%)|100.15|||||TWO_SIDED|90.0|98.23|102.1|||Mixed Models Analysis|"Model on logarithmic scale included subjects within sequence as random effect and sequence, period, and treatment as fixed effects."|Ratio calculated as T80/A5/H12.5 mg FDC divided by T80/H12.5 FDC + A5 mono.|Adjusted by-treatment means on the log-transformed scale for hydrochlorothiazide 12.5 mg||102.10|98.23|
72533484|NCT02129192|144596119|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio (%)|64.4||||1|TWO_SIDED|90.0|59.59|69.59|||ANOVA|"Model included subject as random effect and feeding condition as fixed effect."|Ratio calculated as T80/A5/H12.5 mg FDC Fed divided by T80/A5/H12.5 mg FDC Fasted.|Adjusted by-treatment geometric means for telmisartan 80 mg. No hypothesis was tested.||69.59|59.59|1.0000
72533485|NCT02129192|144596119|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio (%)|99.45|||<|0.0001|TWO_SIDED|90.0|96.69|102.29|||ANOVA|"Model included subject as random effect and feeding condition as fixed effect."|Ratio calculated as T80/A5/H12.5 mg FDC Fed divided by T80/A5/H12.5 mg FDC Fasted.|Adjusted by-treatment geometric means for amlodipine 5 mg. No hypothesis was tested.||102.29|96.69|<0.0001
72533486|NCT02129192|144596119|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio (%)|89.82|||<|0.0001|TWO_SIDED|90.0|86.02|93.79|||ANOVA|"Model included subject as random effect and feeding condition as fixed effect."|Ratio calculated as T80/A5/H12.5 mg FDC Fed divided by T80/A5/H12.5 mg FDC Fasted.|Adjusted by-treatment geometric means for hydrochlorothiazide 12.5 mg. No hypothesis was tested.||93.79|86.02|<0.0001
72533487|NCT00976521|144596132|SUPERIORITY_OR_OTHER|||||||0.034||95.0|||||Wilcoxon (Mann-Whitney)|||The primary endpoint of infarct size at 30 days measured by cardiac MRI, was summarized using the median, IQR, minimum and maximum values, in each infusion group, comparing the pooled active infusion arm to the pooled control non-infusion arm with the Wilcoxon rank sum test in the ITT analysis set. Data was only analyzed in subjects completing the cardiac MRI study and for whom the imaging data was received and deemed analyzable by the core laboratory.||||0.034
72533488|NCT00976521|144596133|SUPERIORITY_OR_OTHER|||||||0.51||95.0|||||Wilcoxon (Mann-Whitney)|||The primary endpoint of infarct size at 30 days measured by cardiac MRI, was summarized using the median, IQR, minimum and maximum values, in each infusion group, comparing the pooled active infusion arm to the pooled control non-infusion arm with the Wilcoxon rank sum test in the ITT analysis set. Data was only analyzed in subjects completing the cardiac MRI study and for whom the imaging data was received and deemed analyzable by the core laboratory.||||0.51
72533489|NCT03039699|144596142|SUPERIORITY|||||||0.004|||||||t-test, 2 sided|||||||0.004
72533490|NCT03039699|144596143|SUPERIORITY|||||||0.0675||||||p-value adjusted for multiple comparisons using Holm method|Fisher Exact|||48 hours timepoint comparison||||0.0675
72533491|NCT03039699|144596143|SUPERIORITY|||||||0.0675||||||p-value adjusted for multiple comparisons using Holm method|Fisher Exact|||72 hours timepoint comparison||||0.0675
72533492|NCT03039699|144596143|SUPERIORITY|||||||0.5569||||||p-value adjusted for multiple comparisons using Holm method|Fisher Exact|||96 hours timepoint comparison||||0.5569
72533493|NCT03039699|144596144|SUPERIORITY|||||||0.0696||||||p-value adjusted for multiple comparisons using Holm method|Fisher Exact|||48 hours timepoint comparison||||0.0696
72533494|NCT03039699|144596144|SUPERIORITY|||||||0.0696||||||p-value adjusted for multiple comparisons using Holm method|Fisher Exact|||72 hours timepoint comparison||||0.0696
72533495|NCT03039699|144596144|SUPERIORITY|||||||0.1998||||||p-value adjusted for multiple comparisons using Holm method|Fisher Exact|||96 hours timepoint comparison||||0.1998
72533496|NCT03039699|144596145|SUPERIORITY|||||||0.0039|||||||Wilcoxon (Mann-Whitney)|||||||0.0039
72533497|NCT03039699|144596146|SUPERIORITY|||||||0.89||||||"The p-value associated with treatment\*visit interaction of total CDS score from 24 hours to 48 and 72 hours of treatment between Ergoferon and Placebo treatment groups. Model includes treatment, visit and treatment\*visit interaction."|Mixed Models Analysis|||||||0.89
72533498|NCT03039699|144596147|SUPERIORITY|||||||0.0044|||||||Wilcoxon (Mann-Whitney)|||||||0.0044
72533499|NCT03039699|144596148|SUPERIORITY|||||||0.5488||||||nonadjusted p-value|Fisher Exact|||Day 3 comparison||||0.5488
72533500|NCT03039699|144596148|SUPERIORITY|||||||0.814||||||nonadjusted p-value|Fisher Exact|||Day 4 comparison||||0.8140
72533501|NCT03039699|144596148|SUPERIORITY|||||||0.1248||||||nonadjusted p-value|Fisher Exact|||Day 6 comparison||||0.1248
72533502|NCT03039699|144596148|SUPERIORITY|||||||0.3889||||||nonadjusted p-value|Fisher Exact|||Day 10 comparison||||0.3889
72533503|NCT03039699|144596149|SUPERIORITY|||||||0.3593|||||||Fisher Exact|||||||0.3593
72533504|NCT00129220|144596150|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-5.62|||<|0.001|TWO_SIDED|95.0|-8.87|-2.37|||ANCOVA||Least Squares Mean Difference = Olanzapine minus Placebo.|||-2.37|-8.87|<0.001
72533505|NCT00129220|144596151|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.78||||0.774|TWO_SIDED|95.0|-6.15|4.59|||ANCOVA||Least Squares Mean Difference = Olazapine minus Haloperidol.|||4.59|-6.15|0.774
72533506|NCT00129220|144596152|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|21.0||||0.064|TWO_SIDED|95.0|1.6|40.4|||Cochran-Mantel-Haenszel||Least Squares Mean Difference = Olanzapine minus Haloperidol.|||40.4|1.6|0.064
72533507|NCT00129220|144596153|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.47||||0.171|TWO_SIDED|95.0|-1.15|0.21|||ANCOVA||Least Squares Mean Difference = Olanzapine minus Haloperidol.|||0.21|-1.15|0.171
72533508|NCT00129220|144596154|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.51||||0.006|TWO_SIDED|95.0|-0.87|-0.15||P-value for 3-Week Change.|ANCOVA||Least Squares Mean Difference = Olanzapine minus Placebo.|||-0.15|-0.87|0.006
72533509|NCT00129220|144596154|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.13||||0.722|TWO_SIDED|95.0|-0.82|0.57||P-value for 6-Week Change.|ANCOVA||Least Squares Mean Difference = Olanzapine minus Haloperidol.|||0.57|-0.82|0.722
72533510|NCT00129220|144596155|SUPERIORITY_OR_OTHER||Mean Difference (Net)|6.7||||0.333|TWO_SIDED|95.0|-6.7|20.1||P-value for 3-Week Response Rate.|Cochran-Mantel-Haenszel|||||20.1|-6.7|0.333
72533511|NCT00129220|144596155|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.3||||0.908|TWO_SIDED|95.0|-21.0|18.4||P-value for 6-Week Response Rate.|Cochran-Mantel-Haenszel|||||18.4|-21.0|0.908
72533512|NCT00129220|144596156|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|5.9||||0.384|TWO_SIDED|95.0|-7.3|19.2||P-value for 3-Week Remission Rate.|Cochran-Mantel-Haenszel||Least Squares Mean Difference = Olanzapine minus Placebo.|||19.2|-7.3|0.384
72533513|NCT00129220|144596156|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.3||||0.982|TWO_SIDED|95.0|-21.3|21.8||P-value is for 6-Week Remission Rate|Cochran-Mantel-Haenszel||Least Squares Mean Difference = Olanzapine minus Haloperidol.|||21.8|-21.3|0.982
72533514|NCT00129220|144596157|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.8||||0.698|TWO_SIDED|95.0|-3.2|4.9||P-value for 3-Week Symptomatic Depression Rate.|Cochran-Mantel-Haenszel|||||4.9|-3.2|0.698
72533515|NCT00129220|144596157|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-14.1||||0.014|TWO_SIDED|95.0|-31.7|3.4||P-value for 6-Week Symptomatic Depression Rate.|Cochran-Mantel-Haenszel|||||3.4|-31.7|0.014
72533516|NCT00129220|144596158|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-1.48||||0.019|TWO_SIDED|95.0|-2.71|-0.25||P-value for 3-Week Change.|ANCOVA||Least Squares Mean Difference = Olanzapine minus Placebo.|||-0.25|-2.71|0.019
72533517|NCT00129220|144596158|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.16||||0.855|TWO_SIDED|95.0|-1.95|1.62||P-value for 6-Week Change.|ANCOVA||Least Squares Mean Difference = Olanzapine minus Haloperidol.|||1.62|-1.95|0.855
72533518|NCT00129220|144596159|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.6||||0.136|TWO_SIDED|95.0|-14.9|5.7||P-value for 6-Week Syndromic Depression Rate.|Cochran-Mantel-Haenszel|||||5.7|-14.9|0.136
72533519|NCT00129220|144596160|SUPERIORITY_OR_OTHER|||||||0.003||95.0||||P-value for Maximum Change from Baseline.|Wilcoxon Rank Sum|||||||0.003
72533520|NCT01883362|144596161|SUPERIORITY||Hazard Ratio (HR)|0.46||||0.2655|TWO_SIDED|95.0|0.12|1.86|||Log Rank|||||1.86|0.12|0.2655
72533521|NCT01883362|144596162|SUPERIORITY||Hazard Ratio (HR)|0.6||||0.4297|TWO_SIDED|95.0|0.17|2.14|||Log Rank|||||2.14|0.17|0.4297
72533522|NCT01883362|144596163|SUPERIORITY||Hazard Ratio (HR)|0.55||||0.2424|TWO_SIDED|95.0|0.2|1.52|||Log Rank|||||1.52|0.20|0.2424
72533523|NCT01883362|144596164|SUPERIORITY||Hazard Ratio (HR)|0.6||||0.4297|TWO_SIDED|95.0|0.17|2.14|||Log Rank|||||2.14|0.17|0.4297
72533524|NCT01883362|144596165|SUPERIORITY||Hazard Ratio (HR)|0.58||||0.3418|TWO_SIDED|95.0|0.19|1.79|||Log Rank|||||1.79|0.19|0.3418
72533525|NCT01883362|144596166|SUPERIORITY||Hazard Ratio (HR)|0.5||||0.4169|TWO_SIDED|95.0|0.09|2.74|||Log Rank|||||2.74|0.09|0.4169
72533526|NCT01458535|144596196|SUPERIORITY_OR_OTHER|||||||0.157|||||||Cochran-Mantel-Haenszel|||||||0.157
72533527|NCT01458535|144596196|SUPERIORITY_OR_OTHER|||||||0.999|||||||Cochran-Mantel-Haenszel|||||||0.999
72533528|NCT01458535|144596196|SUPERIORITY_OR_OTHER|||||||0.045|||||||Cochran-Mantel-Haenszel|||||||0.045
72533529|NCT01238861|144596203|SUPERIORITY_OR_OTHER||Rate Ratio|1.09||||0.781|TWO_SIDED|80.0|0.74|1.59|||Poisson Regression Method||The p-value was calculated by Poisson regression with over-dispersion adjustment factor. The correction for potential over dispersion was made by Pearson chi-square.|||1.59|0.74|0.781
72533530|NCT01238861|144596203|SUPERIORITY_OR_OTHER||Rate Ratio|0.64||||0.173|TWO_SIDED|80.0|0.42|0.97|||Poisson Regression Method||The p-value was calculated by Poisson regression with over-dispersion adjustment factor. The correction for potential over dispersion was made by Pearson chi-square.|||0.97|0.42|0.173
72533531|NCT01238861|144596203|SUPERIORITY_OR_OTHER||Rate ratio|0.59||||0.096|TWO_SIDED|80.0|0.4|0.89|||Poisson Regression Method||The p-value was calculated by Poisson regression with over-dispersion adjustment factor. The correction for potential over dispersion was made by Pearson chi-square.|||0.89|0.40|0.096
72533532|NCT01238861|144596208|SUPERIORITY_OR_OTHER|||||||0.125|||||||ANCOVA|P-value was calculated by analysis of covariance (ANCOVA) with treatment, baseline inhaled steroid status and baseline observed value as covariates.||||||0.125
72533533|NCT01238861|144596208|SUPERIORITY_OR_OTHER|||||||0.074|||||||ANCOVA|P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.||||||0.074
72533534|NCT01238861|144596208|SUPERIORITY_OR_OTHER|||||||0.057|||||||ANCOVA|P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.||||||0.057
72533535|NCT01238861|144596208|SUPERIORITY_OR_OTHER|||||||0.01|||||||ANCOVA|P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.||||||0.010
72533536|NCT01238861|144596210|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.182||||0.131|TWO_SIDED|80.0|-0.336|-0.028|||ANCOVA|P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.||||-0.028|-0.336|0.131
72533537|NCT01238861|144596210|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.173||||0.126|TWO_SIDED|80.0|-0.317|-0.028|||ANCOVA|P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.||||-0.028|-0.317|0.126
72533538|NCT01238861|144596210|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.14||||0.097|TWO_SIDED|80.0|-0.247|-0.032|||ANCOVA|P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.||||-0.032|-0.247|0.097
72533539|NCT01238861|144596211|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.174||||0.642|TWO_SIDED|80.0|-0.654|0.306|||ANCOVA|P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.||Analysis reported for rescue medication use without prophylactic at Week 51-52.||0.306|-0.654|0.642
72533540|NCT01238861|144596211|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.111||||0.824|TWO_SIDED|80.0|-0.533|0.756|||ANCOVA|P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.||Analysis reported for rescue medication use without prophylactic at Week 51-52.||0.756|-0.533|0.824
72533541|NCT01238861|144596211|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.029||||0.91|TWO_SIDED|80.0|-0.297|0.355|||ANCOVA|P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.||Analysis reported for rescue medication use without prophylactic at Week 51-52.||0.355|-0.297|0.910
72533542|NCT01238861|144596211|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.004||||0.992|TWO_SIDED|80.0|-0.602|0.593|||ANCOVA|P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.||Analysis reported for rescue medication use with prophylactic at Week 51-52.||0.593|-0.602|0.992
72533543|NCT01238861|144596211|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.337||||0.624|TWO_SIDED|80.0|-0.548|1.222|||ANCOVA|P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.||Analysis reported for rescue medication use with prophylactic at Week 51-52.||1.222|-0.548|0.624
72533544|NCT01238861|144596211|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.15||||0.645|TWO_SIDED|80.0|-0.267|0.567|||ANCOVA|P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.||Analysis reported for rescue medication use with prophylactic at Week 51-52.||0.567|-0.267|0.645
72533545|NCT01238861|144596212|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.157||||0.014|TWO_SIDED|80.0|0.076|0.237|||ANCOVA|P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.||||0.237|0.076|0.014
72533546|NCT01238861|144596212|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.184||||0.004|TWO_SIDED|80.0|0.102|0.266|||ANCOVA|P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.||||0.266|0.102|0.004
72533547|NCT01238861|144596212|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.091||||0.026|TWO_SIDED|80.0|0.039|0.143|||ANCOVA|P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.||||0.143|0.039|0.026
72533548|NCT01238861|144596213|SUPERIORITY_OR_OTHER|||||||0.384|||||||ANCOVA|P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.||||||0.384
72533549|NCT01238861|144596213|SUPERIORITY_OR_OTHER|||||||0.092|||||||ANCOVA|P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.||||||0.092
72533550|NCT01238861|144596213|SUPERIORITY_OR_OTHER|||||||0.134|||||||ANCOVA|P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.||||||0.134
72533551|NCT01238861|144596213|SUPERIORITY_OR_OTHER|||||||0.129|||||||ANCOVA|P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.||||||0.129
72533552|NCT01238861|144596215|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.404||||0.069|TWO_SIDED|80.0|0.121|0.687|||ANCOVA|P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.||||0.687|0.121|0.069
72533553|NCT01238861|144596215|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.462||||0.049|TWO_SIDED|80.0|0.163|0.761|||ANCOVA|P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.||||0.761|0.163|0.049
72533554|NCT01238861|144596215|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.238||||0.168|TWO_SIDED|80.0|0.017|0.459|||ANCOVA|P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.||||0.459|0.017|0.168
72533555|NCT01238861|144596216|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02||||0.51|TWO_SIDED|80.0|-0.058|0.019|||ANCOVA|P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.||||0.019|-0.058|0.510
72533556|NCT01238861|144596216|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.041||||0.113|TWO_SIDED|80.0|0.008|0.074|||ANCOVA|P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.||||0.074|0.008|0.113
72533557|NCT01238861|144596216|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.011||||0.599|TWO_SIDED|80.0|-0.016|0.038|||ANCOVA|P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.||||0.038|-0.016|0.599
72533558|NCT01238861|144596217|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.373||||0.871|TWO_SIDED|80.0|-3.333|2.586|||ANCOVA|P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.||||2.586|-3.333|0.871
72533559|NCT01238861|144596217|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.857||||0.227|TWO_SIDED|80.0|-0.175|5.889|||ANCOVA|P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.||||5.889|-0.175|0.227
72533560|NCT01238861|144596217|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.139||||0.503|TWO_SIDED|80.0|-1.041|3.319|||ANCOVA|P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.||||3.319|-1.041|0.503
72533561|NCT01238861|144596218|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.907||||0.55|TWO_SIDED|80.0|-4.483|12.297|||ANCOVA|P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.||||12.297|-4.483|0.550
72533562|NCT01238861|144596218|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.659||||0.215|TWO_SIDED|80.0|-0.262|15.579|||ANCOVA|P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.||||15.579|-0.262|0.215
72533563|NCT01238861|144596218|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.54||||0.413|TWO_SIDED|80.0|-2.006|9.086|||ANCOVA|P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.||||9.086|-2.006|0.413
72533564|NCT01238861|144596219|SUPERIORITY_OR_OTHER|||||||0.896|||||||ANCOVA|P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.||||||0.896
72533565|NCT01238861|144596219|SUPERIORITY_OR_OTHER|||||||0.944|||||||ANCOVA|P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.||||||0.944
72533566|NCT01238861|144596219|SUPERIORITY_OR_OTHER|||||||0.667|||||||ANCOVA|P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.||||||0.667
72533567|NCT04602078|144596250|SUPERIORITY|||||||0.444|||||||Log Rank|||Comparisong between subgroups: patients with PD-L1 postive versus patients with PD-L1 negative||||0.444
72533568|NCT04602078|144596251|SUPERIORITY|||||||0.414|||||||Chi-squared|||Comparisong between subgroups: patients with PD-L1 postive versus patients with PD-L1 negative||||0.414
72533569|NCT02706327|144596253|OTHER||||||<|0.001||||||A post-hoc test was used with Bonferroni correction and adjusted p-value was 0.016.|Kruskal-Wallis|Effect sizes (Cohen's d) were calculated for significant differences.||Normality of the distribution was investigated by skewness-kurtosis, histogram graphics, normality tests and plots before the statistical tests were performed. Group comparisons were tested with One-way analysis of variance when normality was achieved and Kruskal Wallis test when not. A post-hoc test was used with Bonferroni correction.||||<0.001
72533570|NCT02706327|144596254|OTHER|||||||0.547|||||||Kruskal-Wallis|||Normality of the distribution was investigated by skewness-kurtosis, histogram graphics, normality tests and plots before the statistical tests were performed. Group comparisons were tested with One-way analysis of variance when normality was achieved and Kruskal Wallis test when not.||||0.547
72533571|NCT02706327|144596255|OTHER|||||||0.895|||||||Kruskal-Wallis|||Normality of the distribution was investigated by skewness-kurtosis, histogram graphics, normality tests and plots before the statistical tests were performed. Group comparisons were tested with One-way analysis of variance when normality was achieved and Kruskal Wallis test when not.||||0.895
72533572|NCT02706327|144596256|OTHER|||||||0.842|||||||Kruskal-Wallis|||Normality of the distribution was investigated by skewness-kurtosis, histogram graphics, normality tests and plots before the statistical tests were performed. Group comparisons were tested with One-way analysis of variance when normality was achieved and Kruskal Wallis test when not.||||0.842
72533573|NCT02706327|144596257|OTHER|||||||0.848|||||||Kruskal-Wallis|||Normality of the distribution was investigated by skewness-kurtosis, histogram graphics, normality tests and plots before the statistical tests were performed. Group comparisons were tested with One-way analysis of variance when normality was achieved and Kruskal Wallis test when not.||||0.848
72533574|NCT06104423|144596292|SUPERIORITY||Mean difference pre vs post treatment|-19.2|STANDARD_DEVIATION|8.62|<|0.001|TWO_SIDED|95.0|-26.0|-14.0|||paired t-test|||Primary endpoint, verified on the single cohort of patients who completed the monotherapy run-in period, is calculated as the mean difference in sitting systolic blood pressure between Visit 2 (Week 0, Baseline Visit of the combination therapy) and Visit 5 (Week 12, End of Study Visit). This is not a comparison of two different arms, but a comparison of two measurements taken from the same patient treated with combination therapy (single arm paired pre- vs. post-combination therapy comparison)||-14.0|-26.0|< 0.001
72626302|NCT00402987|144781747|SUPERIORITY_OR_OTHER_LEGACY|||||||0.038||95.0||||"Analysis at 7 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.038
72533575|NCT03417245|144596293|SUPERIORITY||ABR ratio|0.101|||<|0.0001|TWO_SIDED|95.0|0.064|0.159||P-value derived from NB regression model during EP, with treatment arm, number of bleeds in 6 months prior to study (\<=10, \>10) and hemophilia type (A vs B) as fixed effects. Significance threshold was at 0.05.|Negative binomial regression mode|||||0.159|0.064|<0.0001
72533576|NCT03417245|144596295|SUPERIORITY||ABR ratio|0.13|||<|0.0001|TWO_SIDED|95.0|0.09|0.188||P-value derived from NB regression model during TP, with treatment arm, number of bleeds in 6 months prior to study (\<=10, \>10) and hemophilia type (A vs B) as fixed effects. Significance threshold was at 0.05.|Negative binomial regression model|||||0.188|0.090|<0.0001
72533577|NCT03417245|144596297|SUPERIORITY||ABR ratio|0.083|||<|0.0001|TWO_SIDED|95.0|0.049|0.141||P-value derived from NB regression model during EP, with treatment arm, number of bleeds in 6 months prior to study (\<=10, \>10) and hemophilia type (A vs B) as fixed effects. Significance threshold was at 0.05.|Negative binomial regression model|||||0.141|0.049|<0.0001
72533578|NCT03417245|144596299|SUPERIORITY||ABR ratio|0.097|||<|0.0001|TWO_SIDED|95.0|0.059|0.161||P-value derived from NB regression model during EP, with treatment arm, number of bleeds in 6 months prior to study (\<=10, \>10) and hemophilia type (A vs B) as fixed effects. Significance threshold was at 0.05.|Negative binomial regression model|||||0.161|0.059|<0.0001
72533579|NCT03417245|144596301|SUPERIORITY||Least Square (LS) Mean difference|-19.75|||<|0.0001|TWO_SIDED|95.0|-27.0|-12.5||Analysis of Covariance (ANCOVA) model included treatment arm, number of bleeds in 6 months prior to study (\<=10,\>10) and hemophilia type (A vs B) as fixed effects, Baseline score as covariate. Significance threshold was at 0.05.|ANCOVA|||||-12.50|-27.00|<0.0001
72533580|NCT03417245|144596302|SUPERIORITY||LS Mean difference|-7.07|||=|0.0011|TWO_SIDED|95.0|-11.23|-2.9||ANCOVA model included treatment arm, number of bleeds in 6 months prior to study (\<=10,\>10) and hemophilia type (A vs B) as fixed effects, Baseline score as covariate. Significance threshold was at 0.05.|ANCOVA|||||-2.90|-11.23|=0.0011
72533581|NCT02067728|144596400|SUPERIORITY_OR_OTHER|||||||0.0029|TWO_SIDED||||||Chi-squared|||||||0.0029
72533582|NCT02067728|144596401|SUPERIORITY_OR_OTHER|||||||0.3875|TWO_SIDED||||||t-test, 2 sided|||||||0.3875
72533583|NCT02067728|144596402|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.26|STANDARD_DEVIATION|0.42|<|0.05|TWO_SIDED||||||t-test, 2 sided|||||||<0.05
72533584|NCT02067728|144596403|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Chi-squared|||||||>0.05
72533585|NCT02067728|144596404|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Chi-squared|||||||1.000
72533586|NCT02067728|144596405|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|3.3|||<|0.0001|TWO_SIDED|95.0|2.2|4.9|||Chi-squared|||||4.9|2.2|<0.0001
72533587|NCT02067728|144596406|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|2.9|||<|0.0001|TWO_SIDED|95.0|2.0|4.5|||Chi-squared|||||4.5|2.0|<0.0001
72533588|NCT02067728|144596409|SUPERIORITY_OR_OTHER|||||||0.4835|TWO_SIDED||||||t-test, 2 sided|||||||0.4835
72533589|NCT02067728|144596410|SUPERIORITY_OR_OTHER|||||||0.588|TWO_SIDED||||||t-test, 2 sided|||||||0.5880
72533590|NCT03602976|144596421|SUPERIORITY||Mean Difference (Final Values)|190.7||||0.059|TWO_SIDED||||||t-test, 2 sided|||For GGT||||0.059
72533591|NCT03602976|144596421|SUPERIORITY||Mean Difference (Final Values)|55.5||||0.23|TWO_SIDED||||||t-test, 2 sided|||For Alkaline Phosphatase||||0.23
72533592|NCT03602976|144596422|SUPERIORITY||Mean Difference (Final Values)|2.06||||0.36|TWO_SIDED||||||t-test, 2 sided|||||||0.36
72533593|NCT03602976|144596423|SUPERIORITY||Mean Difference (Final Values)|0.05||||0.73|TWO_SIDED||||||t-test, 2 sided|||||||0.73
72533594|NCT03602976|144596424|SUPERIORITY||Mean Difference (Final Values)|12.2||||0.094|TWO_SIDED||||||t-test, 2 sided|||||||0.094
72533595|NCT03602976|144596425|SUPERIORITY||Mean Difference (Final Values)|21.0||||0.11|TWO_SIDED||||||t-test, 2 sided|||||||0.11
72533596|NCT04837807|144596426|SUPERIORITY||Mean Difference (Final Values)|22.4|STANDARD_DEVIATION|12.8|<|0.05|TWO_SIDED||||||ANOVA|This was a cross-over study, so there is really 30 subjects per group that was analyzed.||"Each participant in the study was asked to complete the IDEEL work at their baseline, week 1 and week 2 visits. The IDEEL work is graded on a scale to 100 with higher numbers being deemed as better scores thus representing more comfort than previous weeks."||||<0.05
72533597|NCT04837807|144596428|SUPERIORITY|OSDI scores were obtained across all three visits, baseline, week 1 and week 2. Lower OSDI scores indicate better eye health.|Mean Difference (Final Values)|10.5|STANDARD_DEVIATION|7.3|<|0.05|TWO_SIDED||||||ANOVA|This was a cross-over study, so there is really 30 subjects per group that was analyzed.||||||<0.05
72533598|NCT00635362|144596457|SUPERIORITY_OR_OTHER_LEGACY|||||||0.35|TWO_SIDED||||||Fisher Exact|||||||0.35
72533599|NCT00635362|144596458|SUPERIORITY_OR_OTHER_LEGACY|||||||0.04|TWO_SIDED||||||Fisher Exact|||||||0.04
72533600|NCT00635362|144596459|SUPERIORITY_OR_OTHER_LEGACY|||||||1|TWO_SIDED|0.0|||||Fisher Exact|||||||1.000
72533601|NCT00635362|144596460|SUPERIORITY_OR_OTHER_LEGACY|||||||0.37|TWO_SIDED|0.0|||||Fisher Exact|||||||0.37
72533602|NCT00635362|144596461|SUPERIORITY_OR_OTHER_LEGACY|||||||1||0.0|||||Fisher Exact|||||||1.00
72533603|NCT04095039|144596462|SUPERIORITY|||||||0.077||||||p-value is based on a sample that is less than 10% of the planned sample size (planned n=4,000)|Finkelstein-Schoenfeld method|||Primary outcome is for the individually randomized cohort since DSMB had concerns about selection bias for the cluster-randomized population due to differences in baseline characteristics that leaned towards the arm objectives.||||0.077
72533604|NCT02309372|144596477|SUPERIORITY||Mean Difference (Net)|-0.76||||0.32|TWO_SIDED|95.0|-2.28|0.77|||t-test, 2 sided|||||0.77|-2.28|0.32
72533605|NCT01590810|144596489|SUPERIORITY_OR_OTHER||Least Squares (LS) Mean Difference|0.78|STANDARD_ERROR_OF_MEAN|1.15||0.503|TWO_SIDED|95.0|-1.59|3.15|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||3.15|-1.59|0.503
72533606|NCT01590810|144596489|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.2|STANDARD_ERROR_OF_MEAN|0.32|<|0.0001|TWO_SIDED|95.0|-2.86|-1.55|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-1.55|-2.86|<0.0001
72533607|NCT01590810|144596489|SUPERIORITY_OR_OTHER||LS Mean Difference|-8.23|STANDARD_ERROR_OF_MEAN|0.92|<|0.0001|TWO_SIDED|95.0|-10.13|-6.34|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-6.34|-10.13|<0.0001
72533608|NCT01590810|144596489|SUPERIORITY_OR_OTHER||LS Mean Difference|-6.84|STANDARD_ERROR_OF_MEAN|1.1|<|0.0001|TWO_SIDED|95.0|-9.1|-4.58|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-4.58|-9.10|<0.0001
72533609|NCT01590810|144596489|SUPERIORITY_OR_OTHER||LS Mean Difference|-10.41|STANDARD_ERROR_OF_MEAN|1.21|<|0.0001|TWO_SIDED|95.0|-12.89|-7.92|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-7.92|-12.89|<0.0001
72533610|NCT01590810|144596490|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.89|STANDARD_ERROR_OF_MEAN|1.4||0.052|TWO_SIDED|95.0|-5.79|0.02|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||0.02|-5.79|0.052
72533611|NCT01590810|144596490|SUPERIORITY_OR_OTHER||LS Mean Difference|-5.46|STANDARD_ERROR_OF_MEAN|1.95||0.01|TWO_SIDED|95.0|-9.49|-1.43|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-1.43|-9.49|0.010
72533612|NCT01590810|144596490|SUPERIORITY_OR_OTHER||LS Mean Difference|-9.49|STANDARD_ERROR_OF_MEAN|2.27|<|0.001|TWO_SIDED|95.0|-14.2|-4.79|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-4.79|-14.20|<0.001
72533613|NCT01590810|144596490|SUPERIORITY_OR_OTHER||LS Mean Difference|-12.02|STANDARD_ERROR_OF_MEAN|2.17|<|0.0001|TWO_SIDED|95.0|-16.51|-7.52|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-7.52|-16.51|<0.0001
72533614|NCT01590810|144596490|SUPERIORITY_OR_OTHER||LS Mean Difference|-9.73|STANDARD_ERROR_OF_MEAN|1.55|<|0.0001|TWO_SIDED|95.0|-12.93|-6.53|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-6.53|-12.93|<0.0001
72533615|NCT01590810|144596491|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.1|STANDARD_ERROR_OF_MEAN|5.61||0.48|TWO_SIDED|95.0|-16.44|8.25|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||8.25|-16.44|0.480
72533616|NCT01590810|144596491|SUPERIORITY_OR_OTHER||LS Mean Difference|-10.79|STANDARD_ERROR_OF_MEAN|5.72||0.086|TWO_SIDED|95.0|-23.37|1.79|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||1.79|-23.37|0.086
72533617|NCT01590810|144596491|SUPERIORITY_OR_OTHER||LS Mean Difference|-17.51|STANDARD_ERROR_OF_MEAN|5.15||0.006|TWO_SIDED|95.0|-28.85|-6.18|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-6.18|-28.85|0.006
72533618|NCT01590810|144596492|SUPERIORITY_OR_OTHER||LS Mean Difference|-13.21|STANDARD_ERROR_OF_MEAN|1.74|<|0.0001|TWO_SIDED|95.0|-16.84|-9.59|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-9.59|-16.84|<0.0001
72533619|NCT01590810|144596492|SUPERIORITY_OR_OTHER||LS Mean Difference|-10.2|STANDARD_ERROR_OF_MEAN|1.8|<|0.0001|TWO_SIDED|95.0|-13.94|-6.45|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-6.45|-13.94|<0.0001
72533620|NCT01590810|144596492|SUPERIORITY_OR_OTHER||LS Mean Difference|-12.82|STANDARD_ERROR_OF_MEAN|1.74|<|0.0001|TWO_SIDED|95.0|-16.45|-9.19|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-9.19|-16.45|<0.0001
72533621|NCT01590810|144596492|SUPERIORITY_OR_OTHER||LS Mean Difference|-12.84|STANDARD_ERROR_OF_MEAN|1.75|<|0.0001|TWO_SIDED|95.0|-16.49|-9.19|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-9.19|-16.49|<0.0001
72533622|NCT01590810|144596493|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.31|STANDARD_ERROR_OF_MEAN|1.18||0.061|TWO_SIDED|95.0|-4.73|0.11|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||0.11|-4.73|0.061
72533623|NCT01590810|144596493|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.23|STANDARD_ERROR_OF_MEAN|0.86||0.016|TWO_SIDED|95.0|-4.0|-0.45|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-0.45|-4.00|0.016
72533624|NCT01590810|144596493|SUPERIORITY_OR_OTHER||LS Mean Difference|-11.62|STANDARD_ERROR_OF_MEAN|1.36|<|0.0001|TWO_SIDED|95.0|-14.42|-8.82|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-8.82|-14.42|<0.0001
72533625|NCT01590810|144596493|SUPERIORITY_OR_OTHER||LS Mean Difference|-8.15|STANDARD_ERROR_OF_MEAN|1.55|<|0.0001|TWO_SIDED|95.0|-11.34|-4.96|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-4.96|-11.34|<0.0001
72533626|NCT01590810|144596493|SUPERIORITY_OR_OTHER||LS Mean Difference|-16.78|STANDARD_ERROR_OF_MEAN|1.96|<|0.0001|TWO_SIDED|95.0|-20.81|-12.75|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-12.75|-20.81|<0.0001
72533627|NCT01590810|144596494|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.95|STANDARD_ERROR_OF_MEAN|1.26||0.029|TWO_SIDED|95.0|-5.56|-0.34|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-0.34|-5.56|0.029
72533628|NCT01590810|144596494|SUPERIORITY_OR_OTHER||LS Mean Difference|-6.76|STANDARD_ERROR_OF_MEAN|2.19||0.005|TWO_SIDED|95.0|-11.29|-2.22|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-2.22|-11.29|0.005
72533629|NCT01590810|144596494|SUPERIORITY_OR_OTHER||LS Mean Difference|-13.48|STANDARD_ERROR_OF_MEAN|3.16|<|0.001|TWO_SIDED|95.0|-20.03|-6.93|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-6.93|-20.03|<0.001
72533630|NCT01590810|144596494|SUPERIORITY_OR_OTHER||LS Mean Difference|-18.33|STANDARD_ERROR_OF_MEAN|1.76|<|0.0001|TWO_SIDED|95.0|-21.98|-14.68|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-14.68|-21.98|<0.0001
72533631|NCT01590810|144596494|SUPERIORITY_OR_OTHER||LS Mean Difference|-16.24|STANDARD_ERROR_OF_MEAN|1.96|<|0.0001|TWO_SIDED|95.0|-20.29|-12.19|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-12.19|-20.29|<0.0001
72533632|NCT01590810|144596495|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.59|STANDARD_ERROR_OF_MEAN|2.51||0.539|TWO_SIDED|95.0|-7.12|3.93|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||3.93|-7.12|0.539
72533633|NCT01590810|144596495|SUPERIORITY_OR_OTHER||LS Mean Difference|-5.36|STANDARD_ERROR_OF_MEAN|3.12||0.113|TWO_SIDED|95.0|-12.23|1.5|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||1.50|-12.23|0.113
72533634|NCT01590810|144596495|SUPERIORITY_OR_OTHER||LS Mean Difference|-14.3|STANDARD_ERROR_OF_MEAN|2.45|<|0.001|TWO_SIDED|95.0|-19.69|-8.91|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-8.91|-19.69|<0.001
72533635|NCT01590810|144596496|SUPERIORITY_OR_OTHER||LS Mean Difference|-12.36|STANDARD_ERROR_OF_MEAN|1.56|<|0.0001|TWO_SIDED|95.0|-15.62|-9.11|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-9.11|-15.62|<0.0001
72533636|NCT01590810|144596496|SUPERIORITY_OR_OTHER||LS Mean Difference|-10.58|STANDARD_ERROR_OF_MEAN|1.51|<|0.0001|TWO_SIDED|95.0|-13.74|-7.42|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-7.42|-13.74|<0.0001
72533637|NCT01590810|144596496|SUPERIORITY_OR_OTHER||LS Mean Difference|-13.63|STANDARD_ERROR_OF_MEAN|1.2|<|0.0001|TWO_SIDED|95.0|-16.12|-11.13|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-11.13|-16.12|<0.0001
72533638|NCT01590810|144596496|SUPERIORITY_OR_OTHER||LS Mean Difference|-12.96|STANDARD_ERROR_OF_MEAN|1.38|<|0.0001|TWO_SIDED|95.0|-15.85|-10.08|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-10.08|-15.85|<0.0001
72626303|NCT00402987|144781747|SUPERIORITY_OR_OTHER_LEGACY|||||||0.019||95.0||||"Analysis at 7 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.019
72533639|NCT01590810|144596497|SUPERIORITY_OR_OTHER||LS Mean Difference|1.05|STANDARD_ERROR_OF_MEAN|0.75||0.175|TWO_SIDED|95.0|-0.5|2.6|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||2.60|-0.50|0.175
72572419|NCT02605993|144672256|OTHER|||||||0.125||||||Hypothesis testing was performed at the 0.05 level of significance. P-value tested whether the percent changes differed from 0.|MMRM|||Statistical Analysis presented is of Cohort 4 at Day 281.||||0.1250
72572420|NCT02603393|144672258|NON_INFERIORITY|Non-inferiority will be demonstrated if the 95% confidence interval of the treatment difference lies entirely to the right of (higher than) -50 mL.|Mean Difference (Final Values)|-0.026||||0.0404||95.0|-0.053|0.001||1 sided|Mixed Model for Repeated Measures Analys|||||0.001|-0.053|0.0404
72572421|NCT02603393|144672259|SUPERIORITY||Ratio of rates|1.08||||0.5802||95.0|0.83|1.4||2 sided|Generalized Linear Model Analysis|||||1.40|0.83|0.5802
72572422|NCT02603393|144672260|SUPERIORITY||Ratio of rates|1.08||||0.5651|TWO_SIDED|95.0|0.82|1.43||2-sided|Generalized Linear Model Analysis|||||1.43|0.82|0.5651
72572423|NCT02603393|144672261|SUPERIORITY||Ratio of rates|1.02||||0.9665|TWO_SIDED|95.0|0.44|2.34||2-sided|Generalized Linear Model Analysis|||||2.34|0.44|0.9665
72572424|NCT02603393|144672262|SUPERIORITY||Mean Difference (Final Values)|-0.026||||0.0573||95.0|-0.053|0.001||2-Sided|Mixed Model for Repeated Measures Analys|||||0.001|-0.053|0.0573
72572425|NCT02603393|144672263|SUPERIORITY||Mean Difference (Final Values)|1.8||||0.0022||95.0|0.7|3.0||2-Sided|Mixed Model for Repeated Measures Analys|||||3.0|0.7|0.0022
72572426|NCT02603393|144672264|SUPERIORITY||Mean Difference (Final Values)|1.4||||0.0221|TWO_SIDED|95.0|0.2|2.6||2-Sided|Mixed Model for Repeated measures Analys|||||2.6|0.2|0.0221
72572427|NCT02603393|144672265|SUPERIORITY||Mean Difference (Final Values)|-0.241||||0.1724||95.0|-0.587|0.105|||Mixed Model for Repeated Measures Analys|||||0.105|-0.587|0.1724
72626304|NCT00402987|144781747|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 8 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
72533640|NCT01590810|144596497|SUPERIORITY_OR_OTHER||LS Mean Difference|2.18|STANDARD_ERROR_OF_MEAN|1.18||0.076|TWO_SIDED|95.0|-0.25|4.61|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||4.61|-0.25|0.076
72533641|NCT01590810|144596497|SUPERIORITY_OR_OTHER||LS Mean Difference|2.18|STANDARD_ERROR_OF_MEAN|0.55||0.001|TWO_SIDED|95.0|1.04|3.32|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||3.32|1.04|0.001
72572428|NCT02603393|144672266|SUPERIORITY||Mean Difference (Final Values)|-0.288||||0.1055||95.0|-0.638|0.061||2-Sided|Mixed Model for Repated Measures Analysi|||||0.061|-0.638|0.1055
72572429|NCT02603393|144672267|SUPERIORITY||Mean Difference (Final Values)|0.177||||0.0641||95.0|-0.01|0.365||2-Sided|Linear Mixed Model Analysis|||||0.365|-0.010|0.0641
72572430|NCT02603393|144672268|SUPERIORITY||Mean Difference (Final Values)|0.018||||0.4107|TWO_SIDED|95.0|-0.025|0.061||2-Sided|Mixed Model for Repeated Measures Analys|||||0.061|-0.025|0.4107
72572431|NCT01783548|144672274|SUPERIORITY_OR_OTHER||LSM treatment difference from placebo|-0.66||||0.002|TWO_SIDED|95.0|-1.08|-0.24||a priori statistical significance is \<0.05.|mixed-model for repeated measures (MMRM)|The MMRM included covariate adjustment for baseline, day, treatment, and the treatment by day interaction.||Based on other studies, the standard deviation for the change from baseline over the first 6 weeks of treatment in the average of AM and PM rTNSS is assumed to be 2.0. Using this standard deviation, 450 subjects aged 6 to 11 years (300 on active treatment of BDP and 150 on placebo) provide approximately 90% power to detect a difference of 0.65 in rTNSS change from baseline between treatment groups with a two-sided alpha level of 0.05.||-0.24|-1.08|0.002
72572432|NCT01783548|144672275|SUPERIORITY_OR_OTHER||LSM treatment difference from placebo|-0.58||||0.004|TWO_SIDED|95.0|-0.99|-0.18||a priori statistical significance is \<0.05.|mixed-model for repeated measures (MMRM)|The MMRM included covariate adjustment for baseline, day, treatment, and the treatment by day interaction.||||-0.18|-0.99|0.004
72572433|NCT01783548|144672276|SUPERIORITY_OR_OTHER||LSM treatment difference from placebo|-0.62||||0.002|TWO_SIDED|95.0|-1.0|-0.23||a priori statistical significance is \<0.05.|mixed-model for repeated measures (MMRM)|The MMRM included covariate adjustment for baseline, day, treatment, and the treatment by day interaction.||||-0.23|-1.00|0.002
72572434|NCT01783548|144672277|SUPERIORITY_OR_OTHER||LSM treatment difference from placebo|-0.54||||0.004|TWO_SIDED|95.0|-0.91|-0.17||a priori statistical significance is \<0.05.|mixed-model for repeated measures (MMRM)|The MMRM included covariate adjustment for baseline, day, treatment, and the treatment by day interaction.||||-0.17|-0.91|0.004
72572435|NCT00988442|144672278|SUPERIORITY_OR_OTHER|||||||1||||||Two-sided 5% significance level.|Fisher Exact|||A Fisher's exact test was used to compare the proportion of participants with virologic suppression, defined as HIV-1 RNA less than 200 copies/mL at week 48 between the standard of care and standard of care + enhanced telephone support groups.||||1.000
72572436|NCT04380090|144672380|SUPERIORITY||Odds Ratio (OR)|1.37||||0.41|TWO_SIDED|95.0|0.65|2.86|||Regression, Logistic||OR for Propylene Glycol use (vs Docusate Sodium), adjusted for operative time and sex (female vs. male)|||2.86|0.65|0.41
72572437|NCT04380090|144672381|SUPERIORITY||Odds Ratio (OR)|0.79||||0.66|TWO_SIDED|95.0|0.28|2.24|||ordinal regression model||OR for Propylene Glycol use (vs Docusate Sodium), adjusted for operative time and sex (female vs. male)|||2.24|0.28|0.66
72626305|NCT00402987|144781747|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 8 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
72626306|NCT00402987|144781747|SUPERIORITY_OR_OTHER_LEGACY|||||||0.081||95.0||||"Analysis at 8 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.081
72533642|NCT01590810|144596497|SUPERIORITY_OR_OTHER||LS Mean Difference|5.64|STANDARD_ERROR_OF_MEAN|1.22|<|0.0001|TWO_SIDED|95.0|3.14|8.15|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||8.15|3.14|<0.0001
72533643|NCT01590810|144596497|SUPERIORITY_OR_OTHER||LS Mean Difference|2.15|STANDARD_ERROR_OF_MEAN|0.74||0.008|TWO_SIDED|95.0|0.63|3.67|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||3.67|0.63|0.008
72533644|NCT01590810|144596498|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.83|STANDARD_ERROR_OF_MEAN|1.39||0.557|TWO_SIDED|95.0|-3.7|2.05|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||2.05|-3.70|0.557
72533645|NCT01590810|144596498|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.48|STANDARD_ERROR_OF_MEAN|1.05||0.175|TWO_SIDED|95.0|-3.65|0.7|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||0.70|-3.65|0.175
72533646|NCT01590810|144596498|SUPERIORITY_OR_OTHER||LS Mean Difference|0.09|STANDARD_ERROR_OF_MEAN|1.52||0.951|TWO_SIDED|95.0|-3.04|3.23|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||3.23|-3.04|0.951
72533647|NCT01590810|144596498|SUPERIORITY_OR_OTHER||LS Mean Difference|2.61|STANDARD_ERROR_OF_MEAN|0.61|<|0.001|TWO_SIDED|95.0|1.34|3.88|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||3.88|1.34|<0.001
72533648|NCT01590810|144596498|SUPERIORITY_OR_OTHER||LS Mean Difference|4.62|STANDARD_ERROR_OF_MEAN|0.78|<|0.0001|TWO_SIDED|95.0|3.0|6.24|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||6.24|3.00|<0.0001
72533649|NCT01590810|144596499|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.45|STANDARD_ERROR_OF_MEAN|1.16||0.241|TWO_SIDED|95.0|-4.01|1.12|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||1.12|-4.01|0.241
72533650|NCT01590810|144596499|SUPERIORITY_OR_OTHER||LS Mean Difference|0.92|STANDARD_ERROR_OF_MEAN|2.07||0.664|TWO_SIDED|95.0|-3.63|5.48|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||5.48|-3.63|0.664
72533651|NCT01590810|144596499|SUPERIORITY_OR_OTHER||LS Mean Difference|3.65|STANDARD_ERROR_OF_MEAN|2.13||0.114|TWO_SIDED|95.0|-1.03|8.33|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||8.33|-1.03|0.114
72533652|NCT01590810|144596500|SUPERIORITY_OR_OTHER||LS Mean Difference|4.42|STANDARD_ERROR_OF_MEAN|4.98||0.385|TWO_SIDED|95.0|-5.96|14.81|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||14.81|-5.96|0.385
72533653|NCT01590810|144596500|SUPERIORITY_OR_OTHER||LS Mean Difference|4.58|STANDARD_ERROR_OF_MEAN|5.15||0.385|TWO_SIDED|95.0|-6.16|15.32|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||15.32|-6.16|0.385
72533654|NCT01590810|144596500|SUPERIORITY_OR_OTHER||LS Mean Difference|5.15|STANDARD_ERROR_OF_MEAN|4.6||0.276|TWO_SIDED|95.0|-4.44|14.74|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||14.74|-4.44|0.276
72533655|NCT01590810|144596500|SUPERIORITY_OR_OTHER||LS Mean Difference|9.5|STANDARD_ERROR_OF_MEAN|4.94||0.069|TWO_SIDED|95.0|-0.81|19.81|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||19.81|-0.81|0.069
72533656|NCT01590810|144596501|SUPERIORITY_OR_OTHER||LS Mean Difference|0.97|STANDARD_ERROR_OF_MEAN|1.09||0.383|TWO_SIDED|95.0|-1.28|3.22|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||3.22|-1.28|0.383
72533657|NCT01590810|144596501|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.75|STANDARD_ERROR_OF_MEAN|0.51||0.002|TWO_SIDED|95.0|-2.79|-0.7|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-0.70|-2.79|0.002
72533658|NCT01590810|144596501|SUPERIORITY_OR_OTHER||LS Mean Difference|-8.11|STANDARD_ERROR_OF_MEAN|0.96|<|0.0001|TWO_SIDED|95.0|-10.08|-6.14|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-6.14|-10.08|<0.0001
72533659|NCT01590810|144596501|SUPERIORITY_OR_OTHER||LS Mean Difference|-6.5|STANDARD_ERROR_OF_MEAN|1.58|<|0.001|TWO_SIDED|95.0|-9.74|-3.25|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-3.25|-9.74|<0.001
72533660|NCT01590810|144596501|SUPERIORITY_OR_OTHER||LS Mean Difference|-10.31|STANDARD_ERROR_OF_MEAN|1.23|<|0.0001|TWO_SIDED|95.0|-12.84|-7.78|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-7.78|-12.84|<0.0001
72533661|NCT01590810|144596502|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.07|STANDARD_ERROR_OF_MEAN|1.62||0.216|TWO_SIDED|95.0|-5.43|1.3|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||1.30|-5.43|0.216
72533662|NCT01590810|144596502|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.8|STANDARD_ERROR_OF_MEAN|2.27||0.046|TWO_SIDED|95.0|-9.51|-0.1|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-0.10|-9.51|0.046
72533663|NCT01590810|144596502|SUPERIORITY_OR_OTHER||LS Mean Difference|-8.93|STANDARD_ERROR_OF_MEAN|2.5||0.002|TWO_SIDED|95.0|-14.1|-3.76|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-3.76|-14.10|0.002
72533664|NCT01590810|144596502|SUPERIORITY_OR_OTHER||LS Mean Difference|-11.16|STANDARD_ERROR_OF_MEAN|2.65|<|0.001|TWO_SIDED|95.0|-16.64|-5.68|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-5.68|-16.64|<0.001
72533665|NCT01590810|144596502|SUPERIORITY_OR_OTHER||LS Mean Difference|-9.25|STANDARD_ERROR_OF_MEAN|1.67|<|0.0001|TWO_SIDED|95.0|-12.7|-5.8|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-5.80|-12.70|<0.0001
72533666|NCT01590810|144596503|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.27|STANDARD_ERROR_OF_MEAN|4.65||0.635|TWO_SIDED|95.0|-12.5|7.96|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||7.96|-12.50|0.635
72533667|NCT01590810|144596503|SUPERIORITY_OR_OTHER||LS Mean Difference|-8.18|STANDARD_ERROR_OF_MEAN|5.18||0.143|TWO_SIDED|95.0|-19.58|3.22|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||3.22|-19.58|0.143
72533668|NCT01590810|144596503|SUPERIORITY_OR_OTHER||LS Mean Difference|-15.51|STANDARD_ERROR_OF_MEAN|4.32||0.004|TWO_SIDED|95.0|-25.01|-6.01|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-6.01|-25.01|0.004
72533669|NCT01590810|144596504|SUPERIORITY_OR_OTHER||LS Mean Difference|-10.84|STANDARD_ERROR_OF_MEAN|1.42|<|0.0001|TWO_SIDED|95.0|-13.79|-7.89|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-7.89|-13.79|<0.0001
72533670|NCT01590810|144596504|SUPERIORITY_OR_OTHER||LS Mean Difference|-8.55|STANDARD_ERROR_OF_MEAN|1.26|<|0.0001|TWO_SIDED|95.0|-11.18|-5.91|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-5.91|-11.18|<0.0001
72533671|NCT01590810|144596504|SUPERIORITY_OR_OTHER||LS Mean Difference|-10.64|STANDARD_ERROR_OF_MEAN|1.34|<|0.0001|TWO_SIDED|95.0|-13.44|-7.84|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-7.84|-13.44|<0.0001
72533672|NCT01590810|144596504|SUPERIORITY_OR_OTHER||LS Mean Difference|-11.13|STANDARD_ERROR_OF_MEAN|1.36|<|0.0001|TWO_SIDED|95.0|-13.97|-8.29|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-8.29|-13.97|<0.0001
72533673|NCT01590810|144596505|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.73|STANDARD_ERROR_OF_MEAN|1.19||0.547|TWO_SIDED|95.0|-3.19|1.73|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||1.73|-3.19|0.547
72533674|NCT01590810|144596505|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.7|STANDARD_ERROR_OF_MEAN|0.53||0.004|TWO_SIDED|95.0|-2.79|-0.62|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-0.62|-2.79|0.004
72533675|NCT01590810|144596505|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.59|STANDARD_ERROR_OF_MEAN|0.8|<|0.0001|TWO_SIDED|95.0|-6.23|-2.94|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-2.94|-6.23|<0.0001
72533676|NCT01590810|144596505|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.37|STANDARD_ERROR_OF_MEAN|0.78|<|0.001|TWO_SIDED|95.0|-4.98|-1.76|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-1.76|-4.98|<0.001
72533677|NCT01590810|144596505|SUPERIORITY_OR_OTHER||LS Mean Difference|-5.92|STANDARD_ERROR_OF_MEAN|1.13|<|0.0001|TWO_SIDED|95.0|-8.24|-3.59|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-3.59|-8.24|<0.0001
72533678|NCT01590810|144596506|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.43|STANDARD_ERROR_OF_MEAN|1.33||0.017|TWO_SIDED|95.0|-6.19|-0.67|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-0.67|-6.19|0.017
72533679|NCT01590810|144596506|SUPERIORITY_OR_OTHER||LS Mean Difference|-5.64|STANDARD_ERROR_OF_MEAN|1.35|<|0.001|TWO_SIDED|95.0|-8.43|-2.84|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-2.84|-8.43|<0.001
72533680|NCT01590810|144596506|SUPERIORITY_OR_OTHER||LS Mean Difference|-5.99|STANDARD_ERROR_OF_MEAN|1.91||0.005|TWO_SIDED|95.0|-9.94|-2.04|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-2.04|-9.94|0.005
72533681|NCT01590810|144596506|SUPERIORITY_OR_OTHER||LS Mean Difference|-7.33|STANDARD_ERROR_OF_MEAN|1.73|<|0.001|TWO_SIDED|95.0|-10.9|-3.76|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-3.76|-10.90|<0.001
72533682|NCT01590810|144596506|SUPERIORITY_OR_OTHER||LS Mean Difference|-5.22|STANDARD_ERROR_OF_MEAN|1.22|<|0.001|TWO_SIDED|95.0|-7.76|-2.69|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-2.69|-7.76|<0.001
72533683|NCT01590810|144596507|SUPERIORITY_OR_OTHER||LS Mean Difference|-6.93|STANDARD_ERROR_OF_MEAN|6.52||0.311|TWO_SIDED|95.0|-21.27|7.42|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||7.42|-21.27|0.311
72533684|NCT01590810|144596507|SUPERIORITY_OR_OTHER||LS Mean Difference|-12.87|STANDARD_ERROR_OF_MEAN|6.62||0.078|TWO_SIDED|95.0|-27.44|1.69|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||1.69|-27.44|0.078
72533685|NCT01590810|144596507|SUPERIORITY_OR_OTHER||LS Mean Difference|-16.03|STANDARD_ERROR_OF_MEAN|6.29||0.027|TWO_SIDED|95.0|-29.87|-2.19|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-2.19|-29.87|0.027
72533686|NCT01590810|144596508|SUPERIORITY_OR_OTHER||LS Mean Difference|-9.77|STANDARD_ERROR_OF_MEAN|1.5|<|0.0001|TWO_SIDED|95.0|-12.9|-6.65|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-6.65|-12.90|<0.0001
72533687|NCT01590810|144596508|SUPERIORITY_OR_OTHER||LS Mean Difference|-7.19|STANDARD_ERROR_OF_MEAN|2.1||0.003|TWO_SIDED|95.0|-11.57|-2.81|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-2.81|-11.57|0.003
72533688|NCT01590810|144596508|SUPERIORITY_OR_OTHER||LS Mean Difference|-8.19|STANDARD_ERROR_OF_MEAN|2.02||0.001|TWO_SIDED|95.0|-12.4|-3.98|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-3.98|-12.40|0.001
72533689|NCT01590810|144596508|SUPERIORITY_OR_OTHER||LS Mean Difference|-7.47|STANDARD_ERROR_OF_MEAN|2.02||0.001|TWO_SIDED|95.0|-11.69|-3.25|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-3.25|-11.69|0.001
72533690|NCT01590810|144596509|SUPERIORITY_OR_OTHER||LS Mean Difference|0.31|STANDARD_ERROR_OF_MEAN|1.04||0.765|TWO_SIDED|95.0|-1.82|2.45|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||2.45|-1.82|0.765
72572438|NCT04380090|144672382|SUPERIORITY||Odds Ratio (OR)|1.28||||0.65|TWO_SIDED|95.0|0.45|3.63|||ordinal regression model||OR for Propylene Glycol use (vs Docusate Sodium), adjusted for operative time and sex (female vs. male)|||3.63|0.45|0.65
72533691|NCT01590810|144596509|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.34|STANDARD_ERROR_OF_MEAN|0.56||0.023|TWO_SIDED|95.0|-2.49|-0.2|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-0.20|-2.49|0.023
72533692|NCT01590810|144596509|SUPERIORITY_OR_OTHER||LS Mean Difference|-6.77|STANDARD_ERROR_OF_MEAN|1.17|<|0.0001|TWO_SIDED|95.0|-9.18|-4.36|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-4.36|-9.18|<0.0001
72533693|NCT01590810|144596509|SUPERIORITY_OR_OTHER||LS Mean Difference|-5.45|STANDARD_ERROR_OF_MEAN|1.95||0.01|TWO_SIDED|95.0|-9.46|-1.44|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-1.44|-9.46|0.010
72533694|NCT01590810|144596509|SUPERIORITY_OR_OTHER||LS Mean Difference|-8.61|STANDARD_ERROR_OF_MEAN|1.3|<|0.0001|TWO_SIDED|95.0|-11.28|-5.94|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-5.94|-11.28|<0.0001
72533695|NCT01590810|144596510|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.02|STANDARD_ERROR_OF_MEAN|1.39||0.16|TWO_SIDED|95.0|-4.89|0.86|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||0.86|-4.89|0.160
72533696|NCT01590810|144596510|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.32|STANDARD_ERROR_OF_MEAN|1.97||0.039|TWO_SIDED|95.0|-8.4|-0.24|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-0.24|-8.40|0.039
72533697|NCT01590810|144596510|SUPERIORITY_OR_OTHER||LS Mean Difference|-7.75|STANDARD_ERROR_OF_MEAN|2.34||0.003|TWO_SIDED|95.0|-12.58|-2.92|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-2.92|-12.58|0.003
72533698|NCT01590810|144596510|SUPERIORITY_OR_OTHER||LS Mean Difference|-9.79|STANDARD_ERROR_OF_MEAN|2.27|<|0.001|TWO_SIDED|95.0|-14.49|-5.09|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-5.09|-14.49|<0.001
72533699|NCT01590810|144596510|SUPERIORITY_OR_OTHER||LS Mean Difference|-8.31|STANDARD_ERROR_OF_MEAN|1.45|<|0.0001|TWO_SIDED|95.0|-11.3|-5.31|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-5.31|-11.30|<0.0001
72533700|NCT01590810|144596511|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.72|STANDARD_ERROR_OF_MEAN|4.0||0.675|TWO_SIDED|95.0|-10.54|7.09|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||7.09|-10.54|0.675
72533701|NCT01590810|144596511|SUPERIORITY_OR_OTHER||LS Mean Difference|-6.76|STANDARD_ERROR_OF_MEAN|4.64||0.174|TWO_SIDED|95.0|-16.98|3.46|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||3.46|-16.98|0.174
72572439|NCT04380090|144672383|EQUIVALENCE|Equivalence is defined as a p-value greater or equal to 0.05 (no difference between groups)||||||0.47|||||||Chi-squared|||||||0.47
72572440|NCT04380090|144672384|EQUIVALENCE|Equivalence is defined as a p-value greater or equal to 0.05 (no difference between groups)||||||0.99|||||||Fisher Exact|||||||0.99
72572441|NCT03055650|144672454|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|Statistical significance is set at α = 0.05.||Change from Baseline in Meibomian Gland Secretion Total Score at Week 1||||<0.0001
72572442|NCT03055650|144672454|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|Statistical significance is set at α = 0.05.||Change from Baseline in Meibomian Gland Secretion Total Score at Month 1||||<0.0001
72626307|NCT00402987|144781747|SUPERIORITY_OR_OTHER_LEGACY|||||||0.552||95.0||||"Analysis at 8 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.552
72408039|NCT03238911|144324430|SUPERIORITY||Mean Difference (Final Values)|-0.51||||0.0008|TWO_SIDED|95.0|-0.8|-0.21|||Mixed model for repeated measures|||"Day 8~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||-0.21|-0.80|0.0008
72408040|NCT03238911|144324430|SUPERIORITY||Mean Difference (Final Values)|-0.8|||<|0.0001|TWO_SIDED|95.0|-1.11|-0.49|||Mixed model for repeated measures|||"Day 14~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||-0.49|-1.11|<0.0001
72408041|NCT03238911|144324430|SUPERIORITY||Mean Difference (Final Values)|-0.64||||0.0006|TWO_SIDED|95.0|-1.01|-0.28|||Mixed model for repeated measures|||"Day 21~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||-0.28|-1.01|0.0006
72626308|NCT00402987|144781747|SUPERIORITY_OR_OTHER_LEGACY|||||||0.05||95.0||||"Analysis at 8 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.050
72533702|NCT01590810|144596511|SUPERIORITY_OR_OTHER||LS Mean Difference|-13.68|STANDARD_ERROR_OF_MEAN|4.03||0.006|TWO_SIDED|95.0|-22.55|-4.81|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-4.81|-22.55|0.006
72533703|NCT01590810|144596512|SUPERIORITY_OR_OTHER||LS Mean Difference|-9.12|STANDARD_ERROR_OF_MEAN|1.49|<|0.0001|TWO_SIDED|95.0|-12.22|-6.03|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-6.03|-12.22|<0.0001
72533704|NCT01590810|144596512|SUPERIORITY_OR_OTHER||LS Mean Difference|-6.86|STANDARD_ERROR_OF_MEAN|1.38|<|0.0001|TWO_SIDED|95.0|-9.73|-3.99|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-3.99|-9.73|<0.0001
72533705|NCT01590810|144596512|SUPERIORITY_OR_OTHER||LS Mean Difference|-8.57|STANDARD_ERROR_OF_MEAN|1.41|<|0.0001|TWO_SIDED|95.0|-11.51|-5.64|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-5.64|-11.51|<0.0001
72533706|NCT01590810|144596512|SUPERIORITY_OR_OTHER||LS Mean Difference|-9.52|STANDARD_ERROR_OF_MEAN|1.45|<|0.0001|TWO_SIDED|95.0|-12.55|-6.5|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-6.50|-12.55|<0.0001
72533707|NCT00412360|144596514|SUPERIORITY|||||||0.17||||||Testing was performed at a significance level of 0.05|Log Rank|||The null hypothesis is that there is no difference in overall survival at one year post-randomization between participants receiving single- and double-unit cord blood transplant. The targeted sample size of 110 participants per treatment group was sufficient to maintain a type I error rate of 5% and provide more than 86% power to detect an increase in overall survival from 57% among participants receiving a single unit graft to 77% for those receiving a double-unit graft.||||0.17
72533708|NCT00412360|144596515|SUPERIORITY|||||||0.11||||||Testing was performed at a significance level of 0.05|Log Rank|||The null hypothesis is that there is no difference in disease-free survival at one year post-randomization between participants receiving single- and double-unit cord blood transplant.||||0.11
72533709|NCT00412360|144596516|SUPERIORITY|||||||0.29||||||Testing was performed at a significance level of 0.05|Gray's test|||The null hypothesis is that there is no difference in the cumulative incidence of neutrophil engraftment between participants receiving single- and double-unit cord blood transplant.||||0.29
72533710|NCT00412360|144596516|SUPERIORITY|||||||0.04||||||Testing was performed at a significance level of 0.05|Gray's test|||The null hypothesis is that there is no difference in the cumulative incidence of platelet engraftment between participants receiving single- and double-unit cord blood transplant.||||0.04
72533711|NCT00412360|144596518|SUPERIORITY|||||||0.78||||||Testing was performed at a significance level of 0.05|Gray's test|||The null hypothesis is that there is no difference in the cumulative incidence of Grade II-IV acute GVHD between participants receiving single- and double-unit cord blood transplant.||||0.78
72533712|NCT00412360|144596518|SUPERIORITY|||||||0.02||||||Testing was performed at a significance level of 0.05|Gray's test|||The null hypothesis is that there is no difference in the cumulative incidence of Grade III-IV acute GVHD between participants receiving single- and double-unit cord blood transplant.||||0.02
72533713|NCT00412360|144596519|SUPERIORITY|||||||0.51||||||Testing was performed at a significance level of 0.05|Gray's test|||The null hypothesis is that there is no difference in the cumulative incidence of chronic GVHD between participants receiving single- and double-unit cord blood transplant.||||0.51
72533714|NCT00412360|144596519|SUPERIORITY|||||||0.05||||||Testing was performed at a significance level of 0.05|Gray's test|||The null hypothesis is that there is no difference in the cumulative incidence of extensive chronic GVHD between participants receiving single- and double-unit cord blood transplant.||||0.05
72533715|NCT00412360|144596521|SUPERIORITY|||||||0.12||||||Testing was performed at a significance level of 0.05|Gray's test|||The null hypothesis is that there is no difference in the cumulative incidence of relapse between participants receiving single- and double-unit cord blood transplant.||||0.12
72533716|NCT00412360|144596522|SUPERIORITY|||||||0.43||||||Testing was performed at a significance level of 0.05|Gray's test|||The null hypothesis is that there is no difference in the cumulative incidence of treatment-related mortality between participants receiving single- and double-unit cord blood transplant.||||0.43
72533717|NCT03655951|144596525|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing post-intervention scores onto baseline scores and the treatment variables.||||||0.2|||||||Regression, Linear|||||||.20
72533718|NCT03655951|144596526|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing post-intervention scores onto baseline scores and the treatment variables.||||||0.69|||||||Regression, Linear|||||||.69
72533719|NCT03655951|144596527|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing follow-up scores onto baseline scores and the treatment variables.||||||0.48|||||||Regression, Linear|||||||.48
72626309|NCT00402987|144781747|SUPERIORITY_OR_OTHER_LEGACY|||||||0.027||95.0||||"Analysis at 8 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.027
72533720|NCT03655951|144596528|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing follow-up scores onto baseline scores and the treatment variables.||||||0.36|||||||Regression, Linear|||||||.36
72533721|NCT03655951|144596529|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing post-intervention scores onto baseline scores and the treatment variables.||||||0.48|||||||Regression, Linear|||||||.48
72533722|NCT03655951|144596530|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing post-intervention scores onto baseline scores and the treatment variables.||||||0.41|||||||Regression, Linear|||||||.41
72533723|NCT03655951|144596531|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing post-intervention scores onto baseline scores and the treatment variables.||||||0.87|||||||Regression, Linear|||||||.87
72533724|NCT03655951|144596532|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing post-intervention scores onto baseline scores and the treatment variables.||||||0.8|||||||Regression, Linear|||||||.8
72533725|NCT03655951|144596533|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing post-intervention scores onto baseline scores and the treatment variables.||||||0.32|||||||Regression, Linear|||||||.32
72533726|NCT03655951|144596534|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing post-intervention scores onto baseline scores and the treatment variables.||||||0.03|||||||Regression, Linear|||||||.03
72533727|NCT03655951|144596535|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing post-intervention scores onto baseline scores and the treatment variables.||||||0.05|||||||Regression, Linear|||||||.05
72533728|NCT03655951|144596536|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing post-intervention scores onto baseline scores and the treatment variables.||||||0.04|||||||Regression, Linear|||||||.04
72533729|NCT03655951|144596537|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing post-intervention scores onto baseline scores and the treatment variables.||||||0.42|||||||Regression, Linear|||||||.42
72533730|NCT03655951|144596538|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing post-intervention scores onto baseline scores and the treatment variables.||||||0.11|||||||Regression, Linear|||||||.11
72533731|NCT03655951|144596539|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing post-intervention scores onto baseline scores and the treatment variables.||||||0.0003|||||||Regression, Linear|||||||.0003
72533732|NCT03655951|144596540|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing post-intervention scores onto baseline scores and the treatment variables.||||||0.97|||||||Regression, Linear|||||||.97
72533733|NCT03655951|144596541|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing post-intervention scores onto baseline scores and the treatment variables.||||||0.08|||||||Regression, Linear|||||||.08
72533734|NCT03655951|144596542|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing post-intervention scores onto baseline scores and the treatment variables.||||||0.7|||||||Regression, Linear|||||||.70
72533735|NCT03655951|144596543|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing post-intervention scores onto baseline scores and the treatment variables.||||||0.03|||||||Regression, Linear|||||||.03
72533736|NCT03655951|144596544|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing post-intervention scores onto baseline scores and the treatment variables.||||||0.29|||||||Regression, Linear|||||||.29
72533737|NCT03655951|144596545|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing post-intervention scores onto baseline scores and the treatment variables.||||||0.36|||||||Regression, Linear|||||||.36
72533738|NCT03655951|144596546|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing post-intervention scores onto baseline scores and the treatment variables.||||||0.61|||||||Regression, Linear|||||||.61
72533739|NCT03655951|144596547|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing post-intervention scores onto baseline scores and the treatment variables.||||||0.72|||||||Regression, Linear|||||||.72
72533740|NCT03655951|144596548|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing post-intervention scores onto baseline scores and the treatment variables.||||||0.05|||||||Regression, Linear|||||||.05
72533741|NCT03655951|144596549|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing post-intervention scores onto baseline scores and the treatment variables.||||||0.09|||||||Regression, Linear|||||||.09
72533742|NCT03655951|144596550|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing post-intervention scores onto baseline scores and the treatment variables.||||||0.69|||||||Regression, Linear|||||||.69
72533743|NCT03655951|144596551|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing post-intervention scores onto baseline scores and the treatment variables.||||||0.11|||||||Regression, Linear|||||||.11
72533744|NCT03655951|144596552|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing post-intervention scores onto baseline scores and the treatment variables.||||||0.27|||||||Regression, Linear|||||||.27
72533745|NCT03655951|144596553|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing post-intervention scores onto baseline scores and the treatment variables.||||||0.83|||||||Regression, Linear|||||||.83
72533746|NCT03655951|144596554|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing post-intervention scores onto baseline scores and the treatment variables.||||||0.0001|||||||Regression, Linear|||||||.0001
72533747|NCT03655951|144596555|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing post-intervention scores onto baseline scores and the treatment variables.||||||0.2|||||||Regression, Linear|||||||.20
72533748|NCT03655951|144596556|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing post-intervention scores onto baseline scores and the treatment variables.||||||0.09|||||||Regression, Linear|||||||.09
72533749|NCT03655951|144596557|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing post-intervention scores onto baseline scores and the treatment variables.||||||0.62|||||||Regression, Linear|||||||.62
72533750|NCT03655951|144596558|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing post-intervention scores onto baseline scores and the treatment variables.||||||0.29|||||||Regression, Linear|||||||.29
72533751|NCT03655951|144596559|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing post-intervention scores onto baseline scores and the treatment variables.||||||0.14|||||||Regression, Linear|||||||.14
72533752|NCT03655951|144596560|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing post-intervention scores onto baseline scores and the treatment variables.||||||0.008|||||||Regression, Linear|||||||.008
72533753|NCT03655951|144596561|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing post-intervention scores onto baseline scores and the treatment variables.||||||0.02|||||||Regression, Linear|||||||.02
72533754|NCT03655951|144596562|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing post-intervention scores onto baseline scores and the treatment variables.||||||0.03|||||||Regression, Linear|||||||.03
72533755|NCT03655951|144596563|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing post-intervention scores onto baseline scores and the treatment variables.||||||0.69|||||||Regression, Linear|||||||.69
72533756|NCT03655951|144596564|EQUIVALENCE|Binary outcomes were assessed with logistic regression.||||||0.4|||||||Regression, Logistic|||||||.4
72533757|NCT03655951|144596565|EQUIVALENCE|Binary outcomes were assessed with logistic regression.||||||0.02|||||||Regression, Logistic|||||||.02
72533758|NCT03655951|144596566|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing follow-up scores onto baseline scores and the treatment variables.||||||0.27|||||||Regression, Linear|||||||.27
72533759|NCT03655951|144596567|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing follow-up scores onto baseline scores and the treatment variables.||||||0.31|||||||Regression, Linear|||||||.31
72533760|NCT03655951|144596568|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing follow-up scores onto baseline scores and the treatment variables.||||||0.11|||||||Regression, Linear|||||||.11
72533761|NCT03655951|144596569|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing follow-up scores onto baseline scores and the treatment variables.||||||0.89|||||||Regression, Linear|||||||.89
72533762|NCT03655951|144596570|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing follow-up scores onto baseline scores and the treatment variables.||||||0.41|||||||Regression, Linear|||||||.41
72533763|NCT03655951|144596571|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing follow-up scores onto baseline scores and the treatment variables.||||||0.93|||||||Regression, Linear|||||||.93
72572443|NCT03055650|144672455|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|Statistical significance is set at α = 0.05.||Change From Baseline in Tear Break-Up Time (TBUT) at Week 1||||<0.0001
72572444|NCT03055650|144672455|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|Statistical significance is set at α = 0.05.||Change From Baseline in Tear Break-Up Time (TBUT) at Month 1||||<0.0001
72572445|NCT03055650|144672456|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|Statistical significance is set at α = 0.025.||Change From Baseline in Standard Patient Evaluation of Eye Dryness (SPEED) Total Score at Week 1||||<0.0001
72533764|NCT03655951|144596572|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing follow-up scores onto baseline scores and the treatment variables.||||||0.83|||||||Regression, Linear|||||||.83
72533765|NCT03655951|144596573|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing follow-up scores onto baseline scores and the treatment variables.||||||0.04|||||||Regression, Linear|||||||.04
72533766|NCT03655951|144596574|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing follow-up scores onto baseline scores and the treatment variables.||||||0.13|||||||Regression, Linear|||||||.13
72533767|NCT03655951|144596575|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing follow-up scores onto baseline scores and the treatment variables.||||||0.56|||||||Regression, Linear|||||||.56
72572446|NCT03055650|144672456|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|Statistical significance is set at α = 0.025.||Change From Baseline in Standard Patient Evaluation of Eye Dryness (SPEED) Total Score at Month 1||||<0.0001
72572447|NCT03055650|144672457|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|Statistical significance is set at α = 0.025.||||||<0.0001
72572448|NCT01791153|144672458|SUPERIORITY_OR_OTHER_LEGACY||Difference in Response Rates|42.0|||<|0.0001|TWO_SIDED|99.5|18.0|66.0|||Cochran-Mantel-Haenszel|||The treatment groups were compared using a Cochran-Mantel-Haenszel model adjusted for the stratification factor of starting prednisone dose (less than or equal to \[\</=\] 30 mg/day, greater than \[\>\] 30 mg/day).||66.00|18.00|<0.0001
72626310|NCT00402987|144781747|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 9 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
72626311|NCT00402987|144781747|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 9 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
72626312|NCT00402987|144781747|SUPERIORITY_OR_OTHER_LEGACY|||||||0.071||95.0||||"Analysis at 9 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.071
72533768|NCT03655951|144596576|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing follow-up scores onto baseline scores and the treatment variables.||||||0.96|||||||Regression, Linear|||||||.96
72533769|NCT03655951|144596577|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing follow-up scores onto baseline scores and the treatment variables.||||||0.35|||||||Regression, Linear|||||||.35
72533770|NCT03655951|144596578|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing follow-up scores onto baseline scores and the treatment variables.||||||0.24|||||||Regression, Linear|||||||.24
72533771|NCT03655951|144596579|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing follow-up scores onto baseline scores and the treatment variables.||||||0.2|||||||Regression, Linear|||||||.2
72626313|NCT00402987|144781747|SUPERIORITY_OR_OTHER_LEGACY|||||||0.609||95.0||||"Analysis at 9 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.609
72626314|NCT00402987|144781747|SUPERIORITY_OR_OTHER_LEGACY|||||||0.065||95.0||||"Analysis at 9 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.065
72626315|NCT00402987|144781747|SUPERIORITY_OR_OTHER_LEGACY|||||||0.042||95.0||||"Analysis at 9 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.042
72626316|NCT00402987|144781747|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 10 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
72533772|NCT03655951|144596580|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing follow-up scores onto baseline scores and the treatment variables.||||||0.18|||||||Regression, Linear|||||||.18
72572449|NCT01791153|144672458|SUPERIORITY_OR_OTHER_LEGACY||Difference in Response Rates|39.06|||<|0.0001|TWO_SIDED|99.5|12.46|65.66|||Cochran-Mantel-Haenszel|||The treatment groups were compared using a Cochran-Mantel-Haenszel model adjusted for the stratification factor of starting prednisone dose (\</=30 mg/day, \>30 mg/day).||65.66|12.46|< 0.0001
72572450|NCT01791153|144672459|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||The treatment groups were compared using a Cochran-Mantel-Haenszel model adjusted for the stratification factor of starting prednisone dose (\</=30 mg/day, \>30 mg/day).||||< 0.0001
72572451|NCT01791153|144672459|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The tocilizumab group was to be considered as non-inferior to the placebo group if the lower limit of the two-sided 99.5% confidence interval was \>/= -22.5%.|Difference in Response Rates|38.35|||||TWO_SIDED|99.5|17.89|58.81||||||The treatment groups were compared using a Cochran-Mantel-Haenszel model adjusted for the stratification factor of starting prednisone dose (\</=30 mg/day, \>30 mg/day).||58.81|17.89|
72572452|NCT01791153|144672459|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0002|||||||Cochran-Mantel-Haenszel|||The treatment groups were compared using a Cochran-Mantel-Haenszel model adjusted for the stratification factor of starting prednisone dose (\</=30 mg/day, \>30 mg/day).||||0.0002
72572453|NCT01791153|144672459|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The tocilizumab group was to be considered as non-inferior to the placebo group if the lower limit of the two-sided 99.5% confidence interval was \>/= -22.5%.|Difference in Response Rates|35.41|||||TWO_SIDED|99.5|10.41|60.41||||||The treatment groups were compared using a Cochran-Mantel-Haenszel model adjusted for the stratification factor of starting prednisone dose (\</=30 mg/day, \>30 mg/day).||60.41|10.41|
72408042|NCT03238911|144324430|SUPERIORITY||Mean Difference (Final Values)|-0.59||||0.0014|TWO_SIDED|95.0|-0.94|-0.23|||Mixed model for repeated measures|||"Day 35~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||-0.23|-0.94|0.0014
72408043|NCT03238911|144324431|SUPERIORITY||Mean Difference (Final Values)|-1.13||||0.7447|TWO_SIDED|95.0|-7.96|5.71|||Mixed model for repeated measures|||"Day 1~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||5.71|-7.96|0.7447
72533773|NCT03655951|144596581|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing follow-up scores onto baseline scores and the treatment variables.||||||0.67|||||||Regression, Linear|||To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing follow-up scores onto baseline scores and the treatment variables.||||.67
72533774|NCT03655951|144596582|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing follow-up scores onto baseline scores and the treatment variables.||||||0.57|||||||Regression, Linear|||||||.57
72533775|NCT03655951|144596583|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing follow-up scores onto baseline scores and the treatment variables.||||||0.65|||||||Regression, Linear|||||||.65
72533776|NCT03655951|144596584|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing follow-up scores onto baseline scores and the treatment variables.||||||0.84|||||||Regression, Linear|||||||.84
72533777|NCT03655951|144596585|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing follow-up scores onto baseline scores and the treatment variables.||||||0.02|||||||Regression, Linear|||||||.02
72533778|NCT03655951|144596586|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing follow-up scores onto baseline scores and the treatment variables.||||||0.65|||||||Regression, Linear|||||||.65
72533779|NCT03655951|144596587|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing follow-up scores onto baseline scores and the treatment variables.||||||0.09|||||||Regression, Linear|||||||.09
72533780|NCT03655951|144596588|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing follow-up scores onto baseline scores and the treatment variables.||||||0.95|||||||Regression, Linear|||||||.95
72533781|NCT03655951|144596589|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing follow-up scores onto baseline scores and the treatment variables.||||||0.47|||||||Regression, Linear|||||||.47
72533782|NCT03655951|144596590|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing follow-up scores onto baseline scores and the treatment variables.||||||0.003|||||||Regression, Linear|||||||.003
72533783|NCT03655951|144596591|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing follow-up scores onto baseline scores and the treatment variables.||||||0.77|||||||Regression, Linear|||||||.77
72533784|NCT03655951|144596592|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing follow-up scores onto baseline scores and the treatment variables.|||||<|0.001|||||||Regression, Linear|||||||<.001
72533785|NCT03655951|144596593|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing follow-up scores onto baseline scores and the treatment variables.||||||0.06|||||||Regression, Linear|||||||.06
72533786|NCT03655951|144596594|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing follow-up scores onto baseline scores and the treatment variables.||||||0.91|||||||Regression, Linear|||||||.91
72533787|NCT03655951|144596595|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing follow-up scores onto baseline scores and the treatment variables.||||||0.95|||||||Regression, Linear|||||||.95
72533788|NCT03655951|144596596|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing follow-up scores onto baseline scores and the treatment variables.||||||0.12|||||||Regression, Linear|||||||.12
72533789|NCT03655951|144596597|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing follow-up scores onto baseline scores and the treatment variables.||||||0.98|||||||Regression, Linear|||||||.98
72533790|NCT03655951|144596598|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing follow-up scores onto baseline scores and the treatment variables.||||||0.57|||||||Regression, Linear|||||||.57
72533791|NCT03655951|144596599|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing follow-up scores onto baseline scores and the treatment variables.||||||0.98|||||||Regression, Linear|||||||.98
72626317|NCT00402987|144781747|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 10 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
72572454|NCT01791153|144672460|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.23|||<|0.0001|TWO_SIDED|99.0|0.11|0.46|||Cox proportional hazards model|||The treatment groups were compared using a Cox proportional hazards model adjusted for the stratification factor of starting prednisone dose (\</=30 mg/day, \>30 mg/day).||0.46|0.11|<0.0001
72572455|NCT01791153|144672460|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.39||||0.0011|TWO_SIDED|99.0|0.18|0.82|||Cox proportional hazards model|||The treatment groups were compared using a Cox proportional hazards model adjusted for the stratification factor of starting prednisone dose (\</=30 mg/day, \>30 mg/day).||0.82|0.18|0.0011
72626318|NCT00402987|144781747|SUPERIORITY_OR_OTHER_LEGACY|||||||0.07||95.0||||"Analysis at 10 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.070
72533792|NCT03655951|144596600|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing follow-up scores onto baseline scores and the treatment variables.||||||0.07|||||||Regression, Linear|||||||.07
72533793|NCT03655951|144596601|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing follow-up scores onto baseline scores and the treatment variables.||||||0.02|||||||Regression, Linear|||||||.02
72533794|NCT03655951|144596602|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing follow-up scores onto baseline scores and the treatment variables.||||||0.15|||||||Regression, Linear|||||||.15
72533795|NCT01790633|144596677|SUPERIORITY_OR_OTHER||||||<|0.001||||||P-value adjustments for multiple comparisons were not necessary. Significance was determined using P \< 0.05|Chi-squared|||We approached our analysis as a pilot study with the aim of addressing feasibility. 70% of patients seen at the MDM clinic obtain a test result with standard serology. Assuming a 20% increase in infection awareness and type 1 error of 0.05, and power of at least 0.9, a minimum of 82 participants per group would be needed.||||<0.001
72533796|NCT01790633|144596678|SUPERIORITY_OR_OTHER|||||||0.7||||||P-value adjustments for multiple comparisons were not necessary. Significance was determined using P \< 0.05|Chi-squared|||||||0.7
72533797|NCT00157157|144596692|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|4.95||||||95.0|1.29|19.06||||||||19.06|1.29|
72533798|NCT00157157|144596693|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|4.18||||||95.0|1.18|14.82||||||||14.82|1.18|
72533799|NCT00157157|144596694|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|4.5||||||95.0|1.05|19.25||||||||19.25|1.05|
72533800|NCT02383966|144596733|OTHER||Hazard Ratio (HR)|0.566|||||TWO_SIDED|95.0|0.4|0.803||||||||0.803|0.400|
72533801|NCT02383966|144596734|OTHER||Hazard Ratio (HR)|0.568|||||TWO_SIDED|95.0|0.406|0.795||||||||0.795|0.406|
72572456|NCT01791153|144672460|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.28||||0.0001|TWO_SIDED|99.0|0.12|0.66|||Cox proportional hazards model|||The treatment groups were compared using a Cox proportional hazards model adjusted for the stratification factor of starting prednisone dose (\</=30 mg/day, \>30 mg/day).||0.66|0.12|0.0001
72572457|NCT01791153|144672460|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.48||||0.0316|TWO_SIDED|99.0|0.2|1.16|||Cox proportional hazards model|||The treatment groups were compared using a Cox proportional hazards model adjusted for the stratification factor of starting prednisone dose (\</=30 mg/day, \>30 mg/day).||1.16|0.20|0.0316
72572458|NCT01791153|144672461|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||Van Elteren's test|||The treatment groups were compared using a Van Elteren's test stratified by starting prednisone dose (\<=30 mg/day, \> 30 mg/day).||||<0.0001
72533802|NCT02383966|144596735|OTHER||Hazard Ratio (HR)|0.705|||||TWO_SIDED|95.0|0.502|0.991||||||||0.991|0.502|
72533803|NCT02383966|144596736|OTHER||Odds Ratio (OR)|2.76|||||TWO_SIDED|95.0|1.52|5.45||||||||5.45|1.52|
72533804|NCT02383966|144596737|OTHER||Odds Ratio (OR)|2.14|||||TWO_SIDED|95.0|1.15|3.95||||||||3.95|1.15|
72533805|NCT02163759|144596740|SUPERIORITY||Difference in Remission Rates|12.3||||0.0173|TWO_SIDED|95.0|1.59|20.6||The threshold for statistical significance was a p-value \<0.05.|Cochran-Mantel-Haenszel|Difference and 95% CI adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL) and MCS (≤9 or ≥10) at BL.|Difference in remission rates was calculated as the etrolizumab arm minus the placebo arm.|The null hypothesis (H0): the percentage of participants achieving remission at Week 10 was the same in both the placebo and etrolizumab arms. The alternative hypothesis (H1): the percentage of participants achieving remission at Week 10 was not the same in the placebo and etrolizumab arms.||20.60|1.59|0.0173
72533806|NCT02163759|144596741|SUPERIORITY||Difference in Remission Rates|-3.1||||0.5055|TWO_SIDED|95.0|-12.61|6.37||Nominal p-value; it has not been adjusted for multiplicity.|Cochran-Mantel-Haenszel|Difference and 95% CI adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL) and MCS (≤9 or ≥10) at BL.|Difference in remission rates was calculated as the etrolizumab arm minus the adalimumab arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. Please refer to the statistical analysis plan for details. This comparison was not considered a key secondary outcome measure and was not part of the multiple testing procedure for statistical significance.||6.37|-12.61|0.5055
72533807|NCT02163759|144596742|SUPERIORITY||Difference in Remission Rates|-5.0||||1|TWO_SIDED|95.0|-11.66|1.75||p-value has been adjusted for multiplicity.|Cochran-Mantel-Haenszel|Difference and 95% CI adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL) and MCS (≤9 or ≥10) at BL.|Difference in remission rates was calculated as the etrolizumab arm minus the adalimumab arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. This comparison was part of Family 3 of the testing procedure; please refer to the statistical analysis plan for details.||1.75|-11.66|1
72572459|NCT01791153|144672461|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||Van Elteren's test|||The treatment groups were compared using a Van Elteren's test stratified by starting prednisone dose (\<=30 mg/day, \> 30 mg/day).||||<0.0001
72572460|NCT01791153|144672461|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0003|||||||Van Elteren's test|||The treatment groups were compared using a Van Elteren's test stratified by starting prednisone dose (\<=30mg/day, \>30mg/day).||||0.0003
72572461|NCT01791153|144672461|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||Van Elteren's test|||The treatment groups were compared using a Van Elteren's test stratified by starting prednisone dose (\<=30 mg/day, \> 30 mg/day).||||<0.0001
72408044|NCT03238911|144324431|SUPERIORITY||Mean Difference (Final Values)|-9.7||||0.0363|TWO_SIDED|95.0|-18.78|-0.63|||Mixed model for repeated measures|||"Day 7~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||-0.63|-18.78|0.0363
72408045|NCT03238911|144324431|SUPERIORITY||Mean Difference (Final Values)|-0.49||||0.9242|TWO_SIDED|95.0|-10.56|9.59|||Mixed model for repeated measures|||"Day 8~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||9.59|-10.56|0.9242
72408046|NCT03238911|144324431|SUPERIORITY||Mean Difference (Final Values)|-11.17||||0.0602|TWO_SIDED|95.0|-22.84|0.49|||Mixed model for repeated measures|||"Day 14~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||0.49|-22.84|0.0602
72533808|NCT02163759|144596743|SUPERIORITY||Difference in Response Rates|6.9||||0.4434|TWO_SIDED|95.0|-7.03|20.62||p-value has been adjusted for multiplicity.|Cochran-Mantel-Haenszel|Difference and 95% CI adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL) and MCS (≤9 or ≥10) at BL.|Difference in response rates was calculated as the etrolizumab arm minus the placebo arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. This comparison was part of Family 1 of the testing procedure; please refer to the statistical analysis plan for details.||20.62|-7.03|0.4434
72533809|NCT02163759|144596743|SUPERIORITY||Difference in Response Rates|4.8||||0.4122|TWO_SIDED|95.0|-6.72|16.07||Nominal p-value; it has not been adjusted for multiplicity.|Cochran-Mantel-Haenszel|Difference and 95% CI adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL) and MCS (≤9 or ≥10) at BL.|Difference in response rates was calculated as the etrolizumab arm minus the adalimumab arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. Please refer to the statistical analysis plan for details. This comparison was not considered a key secondary outcome measure and was not part of the multiple testing procedure for statistical significance.||16.07|-6.72|0.4122
72533810|NCT02163759|144596744|SUPERIORITY||Difference in Response Rates|1.2||||1|TWO_SIDED|95.0|-6.98|9.26||p-value has been adjusted for multiplicity.|Cochran-Mantel-Haenszel|Difference and 95% CI adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL) and MCS (≤9 or ≥10) at BL.|Difference in response rates was calculated as the etrolizumab arm minus the adalimumab arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. This comparison was part of Family 3 of the testing procedure; please refer to the statistical analysis plan for details.||9.26|-6.98|1
72533811|NCT02163759|144596745|SUPERIORITY||Difference in Response Rates|17.9||||0.0173|TWO_SIDED|95.0|4.49|29.5||p-value has been adjusted for multiplicity.|Cochran-Mantel-Haenszel|Difference and 95% CI adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL) and MCS (≤9 or ≥10) at BL.|Difference in response rates was calculated as the etrolizumab arm minus the placebo arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. This comparison was part of Family 1 of the testing procedure; please refer to the statistical analysis plan for details.||29.50|4.49|0.0173
72533812|NCT02163759|144596745|SUPERIORITY||Difference in Response Rates|7.4||||0.1886|TWO_SIDED|95.0|-3.77|18.32||Nominal p-value; it has not been adjusted for multiplicity.|Cochran-Mantel-Haenszel|Difference and 95% CI adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL) and MCS (≤9 or ≥10) at BL.|Difference in response rates was calculated as the etrolizumab arm minus the adalimumab arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. Please refer to the statistical analysis plan for details. This comparison was not considered a key secondary outcome measure and was not part of the multiple testing procedure for statistical significance.||18.32|-3.77|0.1886
72533813|NCT02163759|144596746|SUPERIORITY||Difference in Response Rates|1.9||||1|TWO_SIDED|95.0|-6.04|9.88||p-value has been adjusted for multiplicity.|Cochran-Mantel-Haenszel|Difference and 95% CI adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL) and MCS (≤9 or ≥10) at BL.|Difference in response rates was calculated as the etrolizumab arm minus the adalimumab arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. This comparison was part of Family 3 of the testing procedure; please refer to the statistical analysis plan for details.||9.88|-6.04|1
72533814|NCT02163759|144596747|SUPERIORITY||Difference in Remission Rates|13.8||||0.1347|TWO_SIDED|95.0|2.97|22.15||p-value has been adjusted for multiplicity.|Cochran-Mantel-Haenszel|Difference and 95% CI adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL) and MCS (≤9 or ≥10) at BL.|Difference in remission rates was calculated as the etrolizumab arm minus the placebo arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. This comparison was part of Family 2 of the testing procedure; please refer to the statistical analysis plan for details.||22.15|2.97|0.1347
72626319|NCT00402987|144781747|SUPERIORITY_OR_OTHER_LEGACY|||||||0.689||95.0||||"Analysis at 10 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.689
72533815|NCT02163759|144596747|SUPERIORITY||Difference in Remission Rates|0.5||||0.9138|TWO_SIDED|95.0|-8.95|9.92||Nominal p-value; it has not been adjusted for multiplicity.|Cochran-Mantel-Haenszel|Difference and 95% CI adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL) and MCS (≤9 or ≥10) at BL.|Difference in remission rates was calculated as the etrolizumab arm minus the adalimumab arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. Please refer to the statistical analysis plan for details. This comparison was not considered a key secondary outcome measure and was not part of the multiple testing procedure for statistical significance.||9.92|-8.95|0.9138
72533816|NCT02163759|144596748|SUPERIORITY||Difference in Remission Rates|-3.5||||1|TWO_SIDED|95.0|-10.27|3.3||p-value has been adjusted for multiplicity.|Cochran-Mantel-Haenszel|Difference and 95% CI adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL) and MCS (≤9 or ≥10) at BL.|Difference in remission rates was calculated as the etrolizumab arm minus the adalimumab arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. This comparison was part of Family 5 of the testing procedure; please refer to the statistical analysis plan for details.||3.30|-10.27|1
72533817|NCT02163759|144596749|SUPERIORITY||Difference in Remission Rates|26.3||||0.0173|TWO_SIDED|95.0|12.1|37.86||p-value has been adjusted for multiplicity.|Cochran-Mantel-Haenszel|Difference and 95% CI adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL) and MCS (≤9 or ≥10) at BL.|Difference in remission rates was calculated as the etrolizumab arm minus the placebo arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. This comparison was part of Family 2 of the testing procedure; please refer to the statistical analysis plan for details.||37.86|12.10|0.0173
72533818|NCT02163759|144596749|SUPERIORITY||Difference in Remission Rates|13.2||||0.0313|TWO_SIDED|95.0|0.93|24.94||Nominal p-value; it has not been adjusted for multiplicity.|Cochran-Mantel-Haenszel|Difference and 95% CI adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL) and MCS (≤9 or ≥10) at BL.|Difference in remission rates was calculated as the etrolizumab arm minus the adalimumab arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. Please refer to the statistical analysis plan for details. This comparison was not considered a key secondary outcome measure and was not part of the multiple testing procedure for statistical significance.||24.94|0.93|0.0313
72533819|NCT02163759|144596750|SUPERIORITY||Difference in Remission Rates|-0.3||||1|TWO_SIDED|95.0|-9.13|8.45||p-value has been adjusted for multiplicity.|Cochran-Mantel-Haenszel|Difference and 95% CI adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL) and MCS (≤9 or ≥10) at BL.|Difference in remission rates was calculated as the etrolizumab arm minus the adalimumab arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. This comparison was part of Family 5 of the testing procedure; please refer to the statistical analysis plan for details.||8.45|-9.13|1
72533820|NCT02163759|144596751|SUPERIORITY|||||||0.4434||||||p-value has been adjusted for multiplicity.|Rank ANCOVA|Model adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL), MCS (≤9 or ≥10) at BL, and RB score at BL.||Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. This comparison was part of Family 2 of the testing procedure; please refer to the statistical analysis plan for details.||||0.4434
72533821|NCT02163759|144596751|SUPERIORITY|||||||0.3374||||||Nominal p-value; it has not been adjusted for multiplicity.|Rank ANCOVA|Model adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL), MCS (≤9 or ≥10) at BL, and RB score at BL.||Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. Please refer to the statistical analysis plan for details. This comparison was not considered a key secondary outcome measure and was not part of the multiple testing procedure for statistical significance.||||0.3374
72533822|NCT02163759|144596752|SUPERIORITY|||||||1||||||p-value has been adjusted for multiplicity.|Rank ANCOVA|Model adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL), MCS (≤9 or ≥10) at BL, and RB score at BL.||Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. This comparison was part of Family 5 of the testing procedure; please refer to the statistical analysis plan for details.||||1
72533823|NCT02163759|144596753|SUPERIORITY|||||||0.4434||||||p-value has been adjusted for multiplicity.|Rank ANCOVA|Model adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL), MCS (≤9 or ≥10) at BL, and SF score at BL.||Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. This comparison was part of Family 2 of the testing procedure; please refer to the statistical analysis plan for details.||||0.4434
72533824|NCT02163759|144596753|SUPERIORITY|||||||0.6367||||||Nominal p-value; it has not been adjusted for multiplicity.|Rank ANCOVA|Model adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL), MCS (≤9 or ≥10) at BL, and SF score at BL.||Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. Please refer to the statistical analysis plan for details. This comparison was not considered a key secondary outcome measure and was not part of the multiple testing procedure for statistical significance.||||0.6367
72626320|NCT00402987|144781747|SUPERIORITY_OR_OTHER_LEGACY|||||||0.075||95.0||||"Analysis at 10 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Continuous data were analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.075
72626321|NCT00402987|144781747|SUPERIORITY_OR_OTHER_LEGACY|||||||0.059||95.0||||"Analysis at 10 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.059
72408047|NCT03238911|144324431|SUPERIORITY||Mean Difference (Final Values)|-18.2||||0.0008|TWO_SIDED|95.0|-28.68|-7.73|||Mixed model for repeated measures|||"Day 21~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||-7.73|-28.68|0.0008
72408048|NCT03238911|144324431|SUPERIORITY||Mean Difference (Final Values)|-19.79||||0.0031|TWO_SIDED|95.0|-32.75|-6.83|||Mixed model for repeated measures|||"Day 35~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||-6.83|-32.75|0.0031
72408049|NCT03238911|144324432|SUPERIORITY||Mean Difference (Final Values)|0.037||||0.267|TWO_SIDED|95.0|-0.029|0.104|||Mixed model for repeated measures|||"Day 1~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||0.104|-0.029|0.2670
72408050|NCT03238911|144324432|SUPERIORITY||Mean Difference (Final Values)|0.085||||0.004|TWO_SIDED|95.0|0.028|0.142|||Mixed model for repeated measures|||"Day 7~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||0.142|0.028|0.0040
72408051|NCT03238911|144324432|SUPERIORITY||Mean Difference (Final Values)|0.064||||0.0472|TWO_SIDED|95.0|0.001|0.127|||Mixed model for repeated measures|||"Day 8~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||0.127|0.001|0.0472
72533825|NCT02163759|144596754|SUPERIORITY|||||||1||||||p-value has been adjusted for multiplicity.|Rank ANCOVA|Model adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL), MCS (≤9 or ≥10) at BL, and SF score at BL.||Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. This comparison was part of Family 5 of the testing procedure; please refer to the statistical analysis plan for details.||||1
72533826|NCT02163759|144596755|SUPERIORITY||Mean Difference (Net)|-0.7||||0.3708|TWO_SIDED|95.0|-2.4|0.9||Nominal p-value; it has not been adjusted for multiplicity.|Mixed Model for Repeated Measures|Model adjusted for treatment, visit, stratification factors, treatment-by-visit, baseline UC-PRO/SS domain, and baseline UC-PRO/SS domain-by-visit.|Mean difference was calculated as etrolizumab arm minus placebo arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. Please refer to the statistical analysis plan for details. This comparison was not considered a key secondary outcome measure and was not part of the multiple testing procedure for statistical significance.||0.9|-2.4|0.3708
72533827|NCT02163759|144596755|SUPERIORITY||Mean Difference (Net)|-0.5||||0.4477|TWO_SIDED|95.0|-1.8|0.8||Nominal p-value; it has not been adjusted for multiplicity.|Mixed Model for Repeated Measures|Model adjusted for treatment, visit, stratification factors, treatment-by-visit, baseline UC-PRO/SS domain, and baseline UC-PRO/SS domain-by-visit.|Mean difference was calculated as etrolizumab arm minus adalimumab arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. Please refer to the statistical analysis plan for details. This comparison was not considered a key secondary outcome measure and was not part of the multiple testing procedure for statistical significance.||0.8|-1.8|0.4477
72533828|NCT02163759|144596756|SUPERIORITY||Mean Difference (Net)|-1.0||||1|TWO_SIDED|95.0|-2.1|0.2||p-value has been adjusted for multiplicity.|Mixed Model for Repeated Measures|Model adjusted for treatment, visit, stratification factors, treatment-by-visit, baseline UC-PRO/SS domain, and baseline UC-PRO/SS domain-by-visit.|Mean difference was calculated as etrolizumab arm minus placebo arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. This comparison was part of Family 4 of the testing procedure; please refer to the statistical analysis plan for details.||0.2|-2.1|1
72533829|NCT02163759|144596756|SUPERIORITY||Mean Difference (Net)|-0.3||||1|TWO_SIDED|95.0|-1.2|0.7||p-value has been adjusted for multiplicity.|Mixed Model for Repeated Measures|Model adjusted for treatment, visit, stratification factors, treatment-by-visit, baseline UC-PRO/SS domain, and baseline UC-PRO/SS domain-by-visit.|Mean difference was calculated as etrolizumab arm minus adalimumab arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. This comparison was part of Family 6 of the testing procedure; please refer to the statistical analysis plan for details.||0.7|-1.2|1
72533830|NCT02163759|144596757|SUPERIORITY||Mean Difference (Net)|-0.2||||0.6356|TWO_SIDED|95.0|-0.9|0.5||Nominal p-value; it has not been adjusted for multiplicity.|Mixed Model for Repeated Measures|Model adjusted for treatment, visit, stratification factors, treatment-by-visit, baseline UC-PRO/SS domain, and baseline UC-PRO/SS domain-by-visit.|Mean difference was calculated as etrolizumab arm minus placebo arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. Please refer to the statistical analysis plan for details. This comparison was not considered a key secondary outcome measure and was not part of the multiple testing procedure for statistical significance.||0.5|-0.9|0.6356
72626322|NCT00402987|144781747|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 11 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
72626323|NCT00402987|144781747|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 11 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
72626324|NCT00402987|144781747|SUPERIORITY_OR_OTHER_LEGACY|||||||0.069||95.0||||"Analysis at 11 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.069
72626325|NCT00402987|144781747|SUPERIORITY_OR_OTHER_LEGACY|||||||0.762||95.0||||"Analysis at 11 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.762
72626326|NCT00402987|144781747|SUPERIORITY_OR_OTHER_LEGACY|||||||0.089||95.0||||"Analysis at 11 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.089
72626327|NCT00402987|144781747|SUPERIORITY_OR_OTHER_LEGACY|||||||0.083||95.0||||"Analysis at 11 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.083
72408052|NCT03238911|144324432|SUPERIORITY||Mean Difference (Final Values)|0.101||||0.005|TWO_SIDED|95.0|0.031|0.171|||Mixed model for repeated measures|||"Day 14~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||0.171|0.031|0.0050
72408053|NCT03238911|144324432|SUPERIORITY||Mean Difference (Final Values)|0.101||||0.0061|TWO_SIDED|95.0|0.029|0.172|||Mixed model for repeated measures|||"Day 21~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||0.172|0.029|0.0061
72533831|NCT02163759|144596757|SUPERIORITY||Mean Difference (Net)|-0.4||||0.1253|TWO_SIDED|95.0|-1.0|0.1||Nominal p-value; it has not been adjusted for multiplicity.|Mixed Model for Repeated Measures|Model adjusted for treatment, visit, stratification factors, treatment-by-visit, baseline UC-PRO/SS domain, and baseline UC-PRO/SS domain-by-visit.|Mean difference was calculated as etrolizumab arm minus adalimumab arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. Please refer to the statistical analysis plan for details. This comparison was not considered a key secondary outcome measure and was not part of the multiple testing procedure for statistical significance.||0.1|-1.0|0.1253
72533832|NCT02163759|144596758|SUPERIORITY||Mean Difference (Net)|-0.5||||1|TWO_SIDED|95.0|-1.0|0.0||p-value has been adjusted for multiplicity.|Mixed Model for Repeated Measures|Model adjusted for treatment, visit, stratification factors, treatment-by-visit, baseline UC-PRO/SS domain, and baseline UC-PRO/SS domain-by-visit.|Mean difference was calculated as etrolizumab arm minus placebo arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. This comparison was part of Family 4 of the testing procedure; please refer to the statistical analysis plan for details.||0.0|-1.0|1
72533833|NCT02163759|144596758|SUPERIORITY||Mean Difference (Net)|-0.3||||1|TWO_SIDED|95.0|-0.7|0.1||p-value has been adjusted for multiplicity.|Mixed Model for Repeated Measures|Model adjusted for treatment, visit, stratification factors, treatment-by-visit, baseline UC-PRO/SS domain, and baseline UC-PRO/SS domain-by-visit.|Mean difference was calculated as etrolizumab arm minus adalimumab arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. This comparison was part of Family 6 of the testing procedure; please refer to the statistical analysis plan for details.||0.1|-0.7|1
72533834|NCT02163759|144596759|SUPERIORITY||Difference in Remission Rates|10.9||||0.0364|TWO_SIDED|95.0|-0.08|19.48||Nominal p-value; it has not been adjusted for multiplicity.|Cochran-Mantel-Haenszel|Difference and 95% CI adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL) and MCS (≤9 or ≥10) at BL.|Difference in remission rates was calculated as the etrolizumab arm minus the placebo arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. Please refer to the statistical analysis plan for details. This comparison was not considered a key secondary outcome measure and was not part of the multiple testing procedure for statistical significance.||19.48|-0.08|0.0364
72533835|NCT02163759|144596759|SUPERIORITY||Difference in Remission Rates|-4.5||||0.3383|TWO_SIDED|95.0|-14.1|5.07||Nominal p-value; it has not been adjusted for multiplicity.|Cochran-Mantel-Haenszel|Difference and 95% CI adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL) and MCS (≤9 or ≥10) at BL.|Difference in remission rates was calculated as the etrolizumab arm minus the adalimumab arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. Please refer to the statistical analysis plan for details. This comparison was not considered a key secondary outcome measure and was not part of the multiple testing procedure for statistical significance.||5.07|-14.10|0.3383
72626328|NCT00402987|144781747|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 12 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
72626329|NCT00402987|144781747|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 12 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
72626330|NCT00402987|144781747|SUPERIORITY_OR_OTHER_LEGACY|||||||0.064||95.0||||"Analysis at 12 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.064
72408054|NCT03238911|144324432|SUPERIORITY||Mean Difference (Final Values)|0.055||||0.1282|TWO_SIDED|95.0|-0.016|0.126|||Mixed model for repeated measures|||"Day 35~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||0.126|-0.016|0.1282
72533836|NCT02163759|144596760|SUPERIORITY||Difference in Remission Rates|6.2||||0.09|TWO_SIDED|95.0|-3.33|12.3||Nominal p-value; it has not been adjusted for multiplicity.|Cochran-Mantel-Haenszel|Difference and 95% CI adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL) and MCS (≤9 or ≥10) at BL.|Difference in remission rates was calculated as the etrolizumab arm minus the placebo arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. Please refer to the statistical analysis plan for details. This comparison was not considered a key secondary outcome measure and was not part of the multiple testing procedure for statistical significance.||12.30|-3.33|0.0900
72572462|NCT01791153|144672462|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Square Means|0.61||||0.8067|TWO_SIDED|99.0|-5.86|7.07|||Repeated measures model|||MCS: Change at Week 52: Repeated measures model used for analysis included the following covariates and interactions: treatment, starting prednisone dose (\<=30mg/day, \>30mg/day), visit, treatment-by-visit interaction, starting dose-by-visit interaction, baseline score and baseline score-by-visit interaction.||7.07|-5.86|0.8067
72572463|NCT01791153|144672462|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Square Means|4.44||||0.0252|TWO_SIDED|99.0|-0.69|9.56|||Repeated measures model|||MCS: Change at Week 52: Repeated measures model used for analysis included the following covariates and interactions: treatment, starting prednisone dose (\<=30mg/day, \>30mg/day), visit, treatment-by-visit interaction, starting dose-by-visit interaction, baseline score and baseline score-by-visit interaction.||9.56|-0.69|0.0252
72572464|NCT01791153|144672462|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Square Means|-0.56||||0.8374|TWO_SIDED|99.0|-7.64|6.53|||Repeated measures model|||MCS: Change at Week 52: Repeated measures model used for analysis included the following covariates and interactions: treatment, starting prednisone dose (\<=30mg/day, \>30mg/day), visit, treatment-by-visit interaction, starting dose-by-visit interaction, baseline score and baseline score-by-visit interaction.||6.53|-7.64|0.8374
72626331|NCT00402987|144781747|SUPERIORITY_OR_OTHER_LEGACY|||||||0.841||95.0||||"Analysis at 12 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.841
72626332|NCT00402987|144781747|SUPERIORITY_OR_OTHER_LEGACY|||||||0.11||95.0||||"Analysis at 12 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.110
72626333|NCT00402987|144781747|SUPERIORITY_OR_OTHER_LEGACY|||||||0.119||95.0||||"Analysis at 12 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.119
72626334|NCT00402987|144781747|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001||95.0||||"Analysis at 24 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.001
72626335|NCT00402987|144781747|SUPERIORITY_OR_OTHER_LEGACY|||||||0.015||95.0||||"Analysis at 24 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.015
72626336|NCT00402987|144781747|SUPERIORITY_OR_OTHER_LEGACY|||||||0.087||95.0||||"Analysis at 24 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.087
72626337|NCT00402987|144781747|SUPERIORITY_OR_OTHER_LEGACY|||||||0.826||95.0||||"Analysis at 24 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.826
72626338|NCT00402987|144781747|SUPERIORITY_OR_OTHER_LEGACY|||||||0.345||95.0||||"Analysis at 24 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.345
72626339|NCT00402987|144781747|SUPERIORITY_OR_OTHER_LEGACY|||||||0.53||95.0||||"Analysis at 24 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.530
72626340|NCT00402987|144781748|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.73||||0.149||95.0|0.8|3.7|||Regression, Logistic|Treatment as a factor||||3.7|0.8|0.149
72626341|NCT00402987|144781748|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.95||||0.076||95.0|0.9|4.1|||Regression, Logistic|Treatment as a factor||||4.1|0.9|0.076
72626342|NCT00402987|144781748|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.12||||0.733||95.0|0.6|2.2|||Regression, Logistic|Treatment as a factor||||2.2|0.6|0.733
72626343|NCT00402987|144781749|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.33||||0.03||95.0|1.1|5.0|||Regression, Logistic|Treatment as a factor||||5.0|1.1|0.030
72626344|NCT00402987|144781749|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.33||||0.064||95.0|1.0|5.7|||Regression, Logistic|Treatment as a factor||||5.7|1.0|0.064
72626345|NCT00402987|144781749|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.83||||0.201||95.0|0.7|4.6|||Regression, Logistic|Treatment as a factor||||4.6|0.7|0.201
72626346|NCT00402987|144781749|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.27||||0.575||95.0|0.5|3.0|||Regression, Logistic|Treatment as a factor||||3.0|0.5|0.575
72626347|NCT00402987|144781749|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.0||||1||95.0|0.4|2.2|||Regression, Logistic|Treatment as a factor||||2.2|0.4|1.000
72626348|NCT00402987|144781749|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.27||||0.624||95.0|0.5|3.3|||Regression, Logistic|Treatment as a factor||||3.3|0.5|0.624
72626349|NCT00402987|144781750|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.28|||<|0.001||95.0|0.7|1.9||"Analysis at 2 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||1.9|0.7|<0.001
72626350|NCT00402987|144781750|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.88||||0.003||95.0|0.3|1.5||"Analysis at 2 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||1.5|0.3|0.003
72626351|NCT00402987|144781750|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.4||||0.177||95.0|-1.0|0.2||"Analysis at 2 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||0.2|-1.0|0.177
72626352|NCT00402987|144781750|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.25|||<|0.001||95.0|3.0|7.5||"Analysis at 6 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||7.5|3.0|<0.001
72408055|NCT03238911|144324434|SUPERIORITY||Mean Difference (Final Values)|-0.22||||0.4618|TWO_SIDED|95.0|-0.82|0.37|||Mixed model for repeated measures|||"Day 1~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||0.37|-0.82|0.4618
72533837|NCT02163759|144596760|SUPERIORITY||Difference in Remission Rates|-3.6||||0.3217|TWO_SIDED|95.0|-11.07|3.78||Nominal p-value; it has not been adjusted for multiplicity.|Cochran-Mantel-Haenszel|Difference and 95% CI adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL) and MCS (≤9 or ≥10) at BL.|Difference in remission rates was calculated as the etrolizumab arm minus the adalimumab arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. Please refer to the statistical analysis plan for details. This comparison was not considered a key secondary outcome measure and was not part of the multiple testing procedure for statistical significance.||3.78|-11.07|0.3217
72533838|NCT02163759|144596761|SUPERIORITY||Difference in Adjusted Means|1.3||||0.7919|TWO_SIDED|95.0|-8.3|10.8||Nominal p-value; it has not been adjusted for multiplicity.|ANCOVA|Model adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL), MCS (≤9 or ≥10) at BL, and IBDQ score at BL.|Mean difference was calculated as etrolizumab arm minus placebo arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. Please refer to the statistical analysis plan for details. This comparison was not considered a key secondary outcome measure and was not part of the multiple testing procedure for statistical significance.||10.8|-8.3|0.7919
72533839|NCT02163759|144596761|SUPERIORITY||Difference in Adjusted Means|-0.8||||0.8327|TWO_SIDED|95.0|-8.7|7.0||Nominal p-value; it has not been adjusted for multiplicity.|ANCOVA|Model adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL), MCS (≤9 or ≥10) at BL, and IBDQ score at BL.|Mean difference was calculated as etrolizumab arm minus adalimumab arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. Please refer to the statistical analysis plan for details. This comparison was not considered a key secondary outcome measure and was not part of the multiple testing procedure for statistical significance.||7.0|-8.7|0.8327
72533840|NCT02883400|144596767|SUPERIORITY||Mean Difference (Final Values)|5.0||||0.0001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.0001
72533841|NCT00333437|144596768|SUPERIORITY_OR_OTHER||Change from Baseline|0.1786|STANDARD_DEVIATION|0.1613||0.026|TWO_SIDED|95.0|0.0294|0.3277||Not adjusted|t-test, 2 sided|||H(0): post-pre FVC (liters) = 0||0.3277|0.0294|0.026
72533842|NCT00333437|144596769|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.0|STANDARD_DEVIATION|8.1035||0.3652|TWO_SIDED|95.0|-10.49|4.4945||significant p\<0.05|t-test, 2 sided|||H(0): Post-pre neutrophil count = 0||4.4945|-10.49|0.3652
72533843|NCT00333437|144596769|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.286|STANDARD_DEVIATION|16.358||0.3485|TWO_SIDED|95.0|-21.41|8.8426||significant p\<0.05|t-test, 2 sided|||H(0): post-pre eosinophil count = 0||8.8426|-21.41|0.3485
72533844|NCT00333437|144596771|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|264.26|STANDARD_DEVIATION|194.66||0.0115|TWO_SIDED|95.0|84.256|444.32||Significant p\<0.05|t-test, 2 sided|Not adjusted||H(0): post-pre walk distance = 0||444.32|84.256|0.0115
72533845|NCT00333437|144596772|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.8643|STANDARD_DEVIATION|1.5013||0.0167|TWO_SIDED|95.0|0.4758|3.2527||significant p\<0.05|t-test, 2 sided|||H(0): Post-pre DLCO = 0||3.2527|0.4758|0.0167
72533846|NCT03022526|144596832|SUPERIORITY|||||||0.7463|||||||t-test, 2 sided|||||||0.7463
72533847|NCT03022526|144596833|SUPERIORITY|||||||0.5764|||||||t-test, 2 sided|||||||0.5764
72533848|NCT03022526|144596834|SUPERIORITY|||||||0.7169|||||||t-test, 2 sided|||||||0.7169
72533849|NCT03022526|144596835|SUPERIORITY|||||||0.4226|||||||t-test, 2 sided|||||||0.4226
72626353|NCT00402987|144781750|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.54|||<|0.001||95.0|2.3|6.8||"Analysis at 6 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||6.8|2.3|<0.001
72533850|NCT03022526|144596836|SUPERIORITY|||||||0.6873|||||||t-test, 2 sided|||||||0.6873
72533851|NCT03022526|144596837|SUPERIORITY|||||||0.0452|||||||Chi-squared|||||||0.0452
72533852|NCT03022526|144596838|SUPERIORITY|||||||0.0899|||||||Chi-squared|||||||0.0899
72533853|NCT03022526|144596839|SUPERIORITY|||||||0.1265|||||||Chi-squared|||||||0.1265
72533854|NCT03022526|144596840|SUPERIORITY|||||||0.0328|||||||t-test, 2 sided|||||||0.0328
72533855|NCT03022526|144596841|SUPERIORITY|||||||0.6824|||||||t-test, 2 sided|||||||0.6824
72533856|NCT03022526|144596842|SUPERIORITY|||||||0.449|||||||t-test, 2 sided|||||||0.449
72533857|NCT03022526|144596843|SUPERIORITY|||||||0.5996|||||||t-test, 2 sided|||||||0.5996
72533858|NCT03022526|144596844|SUPERIORITY|||||||0.8009|||||||t-test, 2 sided|||||||0.8009
72533859|NCT03022526|144596845|SUPERIORITY|||||||0.5422|||||||t-test, 2 sided|||||||0.5422
72533860|NCT03022526|144596846|SUPERIORITY|||||||0.7374|||||||t-test, 2 sided|||||||0.7374
72408056|NCT03238911|144324434|SUPERIORITY||Mean Difference (Final Values)|-0.17||||0.366|TWO_SIDED|95.0|-0.54|0.2|||Mixed model for repeated measures|||"Day 7~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||0.20|-0.54|0.3660
72408057|NCT03238911|144324434|SUPERIORITY||Mean Difference (Final Values)|0.02||||0.858|TWO_SIDED|95.0|-0.25|0.3|||Mixed model for repeated measures|||"Day 8~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||0.30|-0.25|0.8580
72533861|NCT00451191|144596850|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05||95.0|||||Simon's optimal two-stage design|||Simon's optimal two-stage design was applied to determine whether there was sufficient activity at either of the two dose levels to warrant further investigation. Each patient was considered either a successful or failed response. The response rate or proportion of patients treated successfully was examined in two stages. At both stages, the two dose levels were compared to pre-determined critical cut-off values. Sample size was based on significance level α=0.05 and power 90%.||||<0.05
72533862|NCT01982942|144596880|SUPERIORITY|||||||0.04|||||||t-test, 2 sided|||The null hypothesis states that the BPF rates of change in the treatment and placebo groups are equal, which can be evaluated based on as assessment of parameter estimates from a linear mixed model (LMM).||||0.04
72533863|NCT03471507|144596886|OTHER|||||||0.46|||||||Regression, Linear|Adjusted for age and sex.||||||0.46
72533864|NCT00750061|144596895|SUPERIORITY_OR_OTHER|||||||0.343|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||change light touch score (wk6-d0)||||0.343
72533865|NCT00750061|144596895|SUPERIORITY_OR_OTHER|||||||0.69|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||change light touch score (m6-d0)||||0.69
72533866|NCT00750061|144596895|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||change pin-prick score (wk6-d0)||||1
72533867|NCT00750061|144596895|SUPERIORITY_OR_OTHER|||||||0.32|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||change pin-prick score (m6-d0)||||0.32
72533868|NCT00750061|144596895|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||change motor score (wk6-d0)||||1
72533869|NCT00750061|144596895|SUPERIORITY_OR_OTHER|||||||0.582|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||change motor score (m6-d0)||||0.582
72533870|NCT00750061|144596896|SUPERIORITY_OR_OTHER|||||||0.257|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||FIM change (Wk6 - D0)||||0.257
72572465|NCT01791153|144672462|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Square Means|3.27||||0.1468|TWO_SIDED|99.0|-2.59|9.14|||Repeated measures model|||MCS: Change at Week 52: Repeated measures model used for analysis included the following covariates and interactions: treatment, starting prednisone dose (\<=30mg/day, \>30mg/day), visit, treatment-by-visit interaction, starting dose-by-visit interaction, baseline score and baseline score-by-visit interaction.||9.14|-2.59|0.1468
72572466|NCT01791153|144672462|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Square Means|4.38||||0.057|TWO_SIDED|99.0|-1.58|10.34|||Repeated measures model|||PCS: Change at Week 52: Repeated measures model used for analysis included the following covariates and interactions: treatment, starting prednisone dose (\<=30mg/day, \>30mg/day), visit, treatment-by-visit interaction, starting dose-by-visit interaction, baseline score and baseline score-by-visit interaction.||10.34|-1.58|0.0570
72572467|NCT01791153|144672462|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Square Means|5.59||||0.0024|TWO_SIDED|99.0|0.86|10.32|||Repeated measures model|||PCS: Change at Week 52: Repeated measures model used for analysis included the following covariates and interactions: treatment, starting prednisone dose (\<=30mg/day, \>30mg/day), visit, treatment-by-visit interaction, starting dose-by-visit interaction, baseline score and baseline score-by-visit interaction.||10.32|0.86|0.0024
72626354|NCT00402987|144781750|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.72||||0.531||95.0|-3.0|1.5||"Analysis at 6 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||1.5|-3.0|0.531
72408058|NCT03238911|144324434|SUPERIORITY||Mean Difference (Final Values)|0.4||||0.0257|TWO_SIDED|95.0|0.05|0.74|||Mixed model for repeated measures|||"Day 14~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||0.74|0.05|0.0257
72533871|NCT00750061|144596896|SUPERIORITY_OR_OTHER|||||||0.168|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||FIM change (M6 - D0)||||0.168
72533872|NCT00750061|144596896|SUPERIORITY_OR_OTHER|||||||0.013|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||VAS change (Wk6 - D0)||||0.013
72533873|NCT00750061|144596896|SUPERIORITY_OR_OTHER|||||||0.137|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||VAS change (M6 - D0)||||0.137
72533874|NCT03246152|144596899|OTHER||||||>|0.05|||||||Pearson's correlation coefficient|||Correlation between change in BCVA and the pre treatment, post treatment, and change in vascular density following 3-6 injections was performed.||||>0.05
72533875|NCT01374516|144596924|SUPERIORITY_OR_OTHER_LEGACY||Vaccine Efficacy|60.8|||||TWO_SIDED|95.0|52.0|68.0||||||The statistical methodology was based on the use of the two-sided 95% confidence interval (CI) of the vaccine efficacy (expressed in %). The CI was calculated using the exact method conditional on the total number of cases in both groups (exact method by Breslow \& Day). The vaccine efficacy of the CYD dengue vaccine was considered significant if the lower bound of its 95% CI was greater than 25%.||68.0|52.0|
72533876|NCT01374516|144596925|SUPERIORITY_OR_OTHER_LEGACY||Vaccine Efficacy|64.7|||||TWO_SIDED|95.0|58.7|69.8||||||The statistical methodology was based on the use of the two-sided 95% CI of the vaccine efficacy (expressed in %) calculated using the exact method conditional on the total number of cases in both groups.||69.8|58.7|
72533877|NCT01374516|144596926|SUPERIORITY_OR_OTHER_LEGACY||Vaccine Efficacy|64.7|||||TWO_SIDED|95.0|58.7|69.9||||||The statistical methodology was based on the use of the two-sided 95% CI of the vaccine efficacy (expressed in %) calculated using the exact method conditional on the total number of cases in both groups.||69.9|58.7|
72533878|NCT01374516|144596927|SUPERIORITY_OR_OTHER_LEGACY||Vaccine Efficacy|61.9|||||TWO_SIDED|95.0|54.7|68.0||||||The statistical methodology was based on the use of the two-sided 95% CI of the vaccine efficacy (expressed in %) calculated using the exact method conditional on the total number of cases in both groups.||68.0|54.7|
72533879|NCT00234533|144596997|OTHER|An one-way Analysis of Covariance (ANOVA) was used to calculate the between patient variation and within patient variation and then the ICC and its confidence limitations.|ICC|0.9|||||TWO_SIDED|95.0|0.88|0.92|||||An ICC ≥ 0.8 was considered satisfactory and indicative that a single sample would be representative of the overall IGF-I status.|An Intra-class Correlation Coefficient (ICC) for the evening series (defined as 12:00 to 24:00) was determined for the overall ITT population to confirm whether only one measurement would be sufficient to accurately represent the IGF-I measurement over Weeks 21, 22 and 23. The ICC expresses the relative magnitude of the 2 components of the total variability, i.e. the biological variability and random error, in a series of measurements on different patients.||0.92|0.88|
72533880|NCT00234533|144596997|OTHER|An one-way ANOVA was used to calculate the between patient variation and within patient variation and then the ICC and its confidence limitations.|ICC|0.92|||||TWO_SIDED|95.0|0.9|0.93|||||An ICC ≥ 0.8 was considered satisfactory and indicative that a single sample would be representative of the overall IGF-I status.|An ICC for the morning series (defined as 06:00 to 12:00) was determined for the overall ITT population to confirm whether only one measurement would be sufficient to accurately represent the IGF-I measurement over Weeks 21, 22 and 23. The ICC expresses the relative magnitude of the 2 components of the total variability, i.e. the biological variability and random error, in a series of measurements on different patients.||0.93|0.90|
72533881|NCT00234533|144596998|OTHER||Fisher's F statistic (F) value|1.79|||||TWO_SIDED|||||||||Analysis of the weekly timing effect (Week 21 versus Week 22 versus Week 23) on the IGF-I value as measured by capillary blood spot method.|For the effect of the weekly timing on the IGF-I levels; F value = 1.79 and the significance probability value, PR\>F = 0.1678.|||
72533882|NCT00234533|144596998|OTHER||F value|1.06|||||TWO_SIDED|||||||||Analysis of the daily timing effect (morning versus evening) on the IGF-I value as measured by capillary blood spot method.|For the effect of the daily timing on the IGF-I levels; F value = 1.06 and the significance probability value, PR\>F = 0.3035|||
72533883|NCT00234533|144596999|OTHER||F value|83.97|||||TWO_SIDED|||||||||Analysis of the effect of the patient's sex (male versus female) on the IGF-I value as measured by capillary blood spot method.|For the effect of the patient's sex on the IGF-I levels; F value = 83.97 and the significance probability value, PR\>F = \<0.0001.|||
72533884|NCT00234533|144596999|OTHER||F value|68.35|||||TWO_SIDED|||||||||Analysis of the effect of the patient's pubertal status (pubertal versus prepubertal) on the IGF-I value as measured by capillary blood spot method.|For the effect of the patient's pubertal status on the IGF-I levels; F value = 68.35 and the significance probability value, PR\>F = \<0.0001.|||
72533885|NCT00234533|144597000|OTHER||F value|10.73|||||TWO_SIDED|||||||||Analysis of the disease condition (GHD versus TS) on the IGF-I value as measured by capillary blood spot method.|For the effect of the disease condition on the IGF-I levels; F value = 10.73 and the significance probability value, PR\>F = 0.0012.|||
72533886|NCT00234533|144597000|OTHER||F value|2.2|||||TWO_SIDED|||||||||Analysis of the country cluster on the IGF-I value as measured by capillary blood spot method.|For the effect of the country cluster on the IGF-I levels; F value = 2.20 and the significance probability value, PR\>F = 0.0701.|||
72533887|NCT00234533|144597001|OTHER||F value|3.65|||||TWO_SIDED|||||||||Analysis of the time of the year on the IGF-I value as measured by capillary blood spot method.|For the effect of the time of the year on the IGF-I levels; F value = 3.65 and the significance probability value, PR\>F = 0.0139.|||
72533888|NCT00234533|144597001|OTHER||F value|7.38|||||TWO_SIDED|||||||||Analysis of the effect of the calculated age at enrolment on the IGF-I value as measured by capillary blood spot method.|For the effect of the calculated age at enrolment on the IGF-I levels; F value = 7.38 and the significance probability value, PR\>F = 0.0073.|||
72533889|NCT00234533|144597001|OTHER||F value|3.86|||||TWO_SIDED|||||||||Analysis of the effect of the disease condition on the IGF-I value as measured by capillary blood spot method.|For the effect of the disease condition on the IGF-I levels; F value = 3.86 and the significance probability value, PR\>F = 0.0511|||
72533890|NCT00234533|144597002|OTHER||Mean difference|-164.79|STANDARD_ERROR_OF_MEAN|159.28|||TWO_SIDED|95.0|-483.35|-153.77||||||The Bland and Altman method was used to compare the results of each of the three simultaneous random capillary and serum measurements were compared. The difference between the capillary blood spot method and the serum IGF-I measurements is presented||-153.77|-483.35|
72533891|NCT01484691|144597013|SUPERIORITY||Mean Difference (Net)|3.04||||0.32|TWO_SIDED|||||This p value is adjusted for multiple comparisons using the false discovery rate (FDR) approach and a p value \<0.05 is taken for significance.|t-test, 2 sided|||mir1||||0.32
72533892|NCT01484691|144597013|SUPERIORITY||Mean Difference (Final Values)|1.91||||0.38|TWO_SIDED|||||This p value is adjusted for multiple comparisons using the false discovery rate (FDR) approach and a p value \<0.05 is taken for significance.|t-test, 2 sided|||mir107||||0.38
72533893|NCT01484691|144597013|SUPERIORITY||Mean Difference (Net)|0.47||||0.83|TWO_SIDED|||||This p value is adjusted for multiple comparisons using the false discovery rate (FDR) approach and a p value \<0.05 is taken for significance.|t-test, 2 sided|||mir128||||0.83
72533894|NCT01484691|144597013|SUPERIORITY||Mean Difference (Net)|1.27||||0.42|TWO_SIDED|||||This p value is adjusted for multiple comparisons using the false discovery rate (FDR) approach and a p value \<0.05 is taken for significance.|t-test, 2 sided|||mir141||||0.42
72533895|NCT01484691|144597013|SUPERIORITY||Mean Difference (Net)|2.55||||0.32|TWO_SIDED|||||This p value is adjusted for multiple comparisons using the false discovery rate (FDR) approach and a p value \<0.05 is taken for significance.|t-test, 2 sided|||mir148b||||0.32
72533896|NCT01484691|144597013|SUPERIORITY||Mean Difference (Net)|0.68||||0.83|TWO_SIDED|||||This p value is adjusted for multiple comparisons using the false discovery rate (FDR) approach and a p value \<0.05 is taken for significance.|t-test, 2 sided|||mir181b||||0.83
72533897|NCT01484691|144597013|SUPERIORITY||Mean Difference (Net)|1.94||||0.38|TWO_SIDED|||||This p value is adjusted for multiple comparisons using the false discovery rate (FDR) approach and a p value \<0.05 is taken for significance.|t-test, 2 sided|||mir185||||0.38
72533898|NCT01484691|144597013|SUPERIORITY||Mean Difference (Net)|2.77||||0.38|TWO_SIDED|||||This p value is adjusted for multiple comparisons using the false discovery rate (FDR) approach and a p value \<0.05 is taken for significance.|t-test, 2 sided|||mir194||||0.38
72626355|NCT00402987|144781751|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|9.07|||<|0.001||95.0|4.4|13.7||"Analysis at 12 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||13.7|4.4|<0.001
72626356|NCT00402987|144781751|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|10.46|||<|0.001||95.0|4.7|16.2||"Analysis at 12 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||16.2|4.7|<0.001
72626357|NCT00402987|144781751|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.96||||0.041||95.0|0.2|11.7||"Analysis at 12 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||11.7|0.2|0.041
72626358|NCT00402987|144781751|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.39||||0.633||95.0|-7.1|4.3||"Analysis at 12 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||4.3|-7.1|0.633
72626359|NCT00402987|144781751|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.11||||0.284||95.0|-2.6|8.8||"Analysis at 12 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||8.8|-2.6|0.284
72626360|NCT00402987|144781751|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.5||||0.18||95.0|-2.1|11.1||"Analysis at 12 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||11.1|-2.1|0.180
72626361|NCT00402987|144781751|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|13.57||||0.009||95.0|3.4|23.7||"Analysis at 24 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||23.7|3.4|0.009
72626362|NCT00402987|144781751|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|14.15||||0.026||95.0|1.7|26.6||"Analysis at 24 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||26.6|1.7|0.026
72626363|NCT00402987|144781751|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|9.39||||0.138||95.0|-3.0|21.8||"Analysis at 24 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||21.8|-3.0|0.138
72626364|NCT00402987|144781751|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.59||||0.926||95.0|-13.0|11.8||"Analysis at 24 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||11.8|-13.0|0.926
72626365|NCT00402987|144781751|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.18||||0.507||95.0|-8.2|16.6||"Analysis at 24 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||16.6|-8.2|0.507
72626366|NCT00402987|144781751|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.77||||0.513||95.0|-9.6|19.1||"Analysis at 24 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||19.1|-9.6|0.513
72626367|NCT00402987|144781752|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.93||||0.023||95.0|1.2|7.4|||Regression, Logistic|Treatment as a factor||||7.4|1.2|0.023
72626368|NCT00402987|144781752|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|3.13||||0.015||95.0|1.2|7.9|||Regression, Logistic|Treatment as a factor||||7.9|1.2|0.015
72533899|NCT01484691|144597013|SUPERIORITY||Mean Difference (Net)|3.38||||0.32|TWO_SIDED|||||This p value is adjusted for multiple comparisons using the false discovery rate (FDR) approach and a p value \<0.05 is taken for significance.|t-test, 2 sided|||mir19a||||0.32
72626369|NCT00402987|144781752|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.07||||0.854||95.0|0.5|2.2|||Regression, Logistic|Treatment as a factor||||2.2|0.5|0.854
72626370|NCT00402987|144781753|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|3.46||||0.013||95.0|1.3|9.2|||Regression, Logistic|Treatment as a factor||||9.2|1.3|0.013
72533900|NCT01484691|144597013|SUPERIORITY||Mean Difference (Net)|0.0||||0.99|TWO_SIDED|||||This p value is adjusted for multiple comparisons using the false discovery rate (FDR) approach and a p value \<0.05 is taken for significance.|t-test, 2 sided|||mir200a||||0.99
72533901|NCT01484691|144597013|SUPERIORITY||Mean Difference (Net)|1.92||||0.38|TWO_SIDED|||||This p value is adjusted for multiple comparisons using the false discovery rate (FDR) approach and a p value \<0.05 is taken for significance.|t-test, 2 sided|||mir22||||0.38
72626371|NCT00402987|144781753|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|5.03||||0.003||95.0|1.7|14.5|||Regression, Logistic|Treatment as a factor||||14.5|1.7|0.003
72533902|NCT01484691|144597013|SUPERIORITY||Mean Difference (Net)|1.57||||0.38|TWO_SIDED|||||This p value is adjusted for multiple comparisons using the false discovery rate (FDR) approach and a p value \<0.05 is taken for significance.|t-test, 2 sided|||mir223||||0.38
72533903|NCT01484691|144597013|SUPERIORITY||Mean Difference (Net)|0.52||||0.83|TWO_SIDED|||||This p value is adjusted for multiple comparisons using the false discovery rate (FDR) approach and a p value \<0.05 is taken for significance.|t-test, 2 sided|||mir23a||||0.83
72533904|NCT01484691|144597013|SUPERIORITY||Mean Difference (Net)|0.81||||0.83|TWO_SIDED|||||This p value is adjusted for multiple comparisons using the false discovery rate (FDR) approach and a p value \<0.05 is taken for significance.|t-test, 2 sided|||mir26a||||0.83
72626372|NCT00402987|144781753|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.99||||0.057||95.0|1.0|9.2|||Regression, Logistic|Treatment as a factor||||9.2|1.0|0.057
72626373|NCT00402987|144781753|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.16||||0.758||95.0|0.5|2.9|||Regression, Logistic|Treatment as a factor||||2.9|0.5|0.758
72626374|NCT00402987|144781753|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.69||||0.381||95.0|0.3|1.6|||Regression, Logistic|Treatment as a factor||||1.6|0.3|0.381
72626375|NCT00402987|144781753|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.68||||0.313||95.0|0.6|4.6|||Regression, Logistic|Treatment as a factor||||4.6|0.6|0.313
72572468|NCT01791153|144672462|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Square Means|3.04||||0.2218|TWO_SIDED|99.0|-3.43|9.51|||Repeated measures model|||PCS: Change at Week 52: Repeated measures model used for analysis included the following covariates and interactions: treatment, starting prednisone dose (\<=30mg/day, \>30mg/day), visit, treatment-by-visit interaction, starting dose-by-visit interaction, baseline score and baseline score-by-visit interaction.||9.51|-3.43|0.2218
72533905|NCT01484691|144597013|SUPERIORITY||Mean Difference (Net)|1.39||||0.38|TWO_SIDED|||||This p value is adjusted for multiple comparisons using the false discovery rate (FDR) approach and a p value \<0.05 is taken for significance.|t-test, 2 sided|||mir320b||||0.38
72533906|NCT01484691|144597013|SUPERIORITY||Mean Difference (Net)|-0.92||||0.38|TWO_SIDED|||||This p value is adjusted for multiple comparisons using the false discovery rate (FDR) approach and a p value \<0.05 is taken for significance.|t-test, 2 sided|||mir598||||0.38
72533907|NCT01484691|144597013|SUPERIORITY||Mean Difference (Net)|0.55||||0.83|TWO_SIDED|||||This p value is adjusted for multiple comparisons using the false discovery rate (FDR) approach and a p value \<0.05 is taken for significance.|t-test, 2 sided|||mir720||||0.83
72572469|NCT01791153|144672462|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Square Means|4.25||||0.0412|TWO_SIDED|99.0|-1.14|9.64|||Repeated measures model|||PCS: Change at Week 52: Repeated measures model used for analysis included the following covariates and interactions: treatment, starting prednisone dose (\<=30mg/day, \>30mg/day), visit, treatment-by-visit interaction, starting dose-by-visit interaction, baseline score and baseline score-by-visit interaction.||9.64|-1.14|0.0412
72533908|NCT01484691|144597013|SUPERIORITY||Mean Difference (Net)|-1.12||||0.3|TWO_SIDED||||||t-test, 2 sided|||mir1915||||0.30
72572470|NCT01791153|144672463|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Square Means|-15.6||||0.0312|TWO_SIDED|99.0|-34.3|3.1|||Repeated measures model|||Change at Week 52: Repeated measures model used for analysis included the following covariates and interactions: treatment, starting prednisone dose (\<=30mg/day, \>30mg/day), visit, treatment-by-visit interaction, starting dose-by-visit interaction, baseline score and baseline score-by-visit interaction.||3.1|-34.3|0.0312
72572471|NCT01791153|144672463|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Square Means|-11.8||||0.0476|TWO_SIDED|99.0|-27.2|3.6|||Repeated measures model|||Change at Week 52: Repeated measures model used for analysis included the following covariates and interactions: treatment, starting prednisone dose (\<=30mg/day, \>30mg/day), visit, treatment-by-visit interaction, starting dose-by-visit interaction, baseline score and baseline score-by-visit interaction.||3.6|-27.2|0.0476
72572472|NCT01791153|144672463|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Square Means|-21.9||||0.0059|TWO_SIDED|99.0|-42.4|-1.4|||Repeated measures model|||Change at Week 52: Repeated measures model used for analysis included the following covariates and interactions: treatment, starting prednisone dose (\<=30mg/day, \>30mg/day), visit, treatment-by-visit interaction, starting dose-by-visit interaction, baseline score and baseline score-by-visit interaction.||-1.4|-42.4|0.0059
72572473|NCT01791153|144672463|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Square Means|-18.2||||0.0081|TWO_SIDED|99.0|-35.8|-0.5|||Repeated measures model|||Change at Week 52: Repeated measures model used for analysis included the following covariates and interactions: treatment, starting prednisone dose (\<=30mg/day, \>30mg/day), visit, treatment-by-visit interaction, starting dose-by-visit interaction, baseline score and baseline score-by-visit interaction.||-0.5|-35.8|0.0081
72572474|NCT00975286|144672476|SUPERIORITY_OR_OTHER||[Least squares (LS) mean difference|-0.32|STANDARD_ERROR_OF_MEAN|0.074|<|0.0001|TWO_SIDED|95.0|-0.463|-0.171||Statistical testing: 2-sided at significance level=0.05. Analysis of covariance (ANCOVA) included treatment arms; randomization strata of Week -1 HbA1c (\<8.0,\>=8.0%) and TZD use (yes/no); country as fixed effects; baseline HbA1c as covariate.|ANCOVA|||To detect a difference of 0.5% (or 0.4%) in change from baseline to Week 24 in HbA1c between lixisenatide and placebo, 225 patients in each arm would provide a power of 98% (or 90%) assuming common standard deviation of 1.3% with a 2-sided test at 5% significance level.||-0.171|-0.463|<0.0001
72572475|NCT01674647|144672492|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.5|||||TWO_SIDED|95.0|0.15|1.73|||no statistical test performed||Crude estimate of the cumulative incidence for rivaroxaban (Xarelto, BAY59-7939): 0.51% (0.20% - 1.17%). Crude estimate of the cumulative incidence for Vitamin K antagonist (VKA): 1.02% (0.40% - 2.34%).|Descriptive comparison of crude estimates of the cumulative incidence and estimation of risk ratio, all with 95% confidence intervals||1.73|0.15|
72572476|NCT01674647|144672493|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.76|||||TWO_SIDED|95.0|0.21|2.67|||no test performed||Crude estimate of the cumulative incidence for rivaroxaban (Xarelto, BAY59-7939): 0.61% (0.26% - 1.27%). Crude estimate of the cumulative incidence for Vitamin K antagonist (VKA): 0.80% (0.27% - 2.00%).|Descriptive comparison of crude estimates of the cumulative incidence and estimation of risk ratio, all with 95% confidence intervals||2.67|0.21|
72572477|NCT01674647|144672494|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.34|||||TWO_SIDED|95.0|0.06|2.0|||no statistical test performed||Crude estimate of the cumulative incidence for rivaroxaban (Xarelto, BAY59-7939): 0.20% (0.04% - 0.71%). Crude estimate of the cumulative incidence for Vitamin K antagonist (VKA): 0.61% (0.17% - 1.72%).|Descriptive comparison of crude estimates of the cumulative incidence and estimation of risk ratio, all with 95% confidence intervals||2.00|0.06|
72626376|NCT00402987|144781754|SUPERIORITY_OR_OTHER_LEGACY||NNT at 6 hours|8.2||||||95.0|4.5|46.4||||||NNT is the inverse of the absolute risk reduction at 6 hours||46.4|4.5|
72626377|NCT00402987|144781754|SUPERIORITY_OR_OTHER_LEGACY||NNT at 6 hours|7.5||||||95.0|4.3|32.0||||||NNT is the inverse of the absolute risk reduction at 6 hours||32.0|4.3|
72533909|NCT01484691|144597013|SUPERIORITY||Mean Difference (Net)|-1.35||||0.38|TWO_SIDED|||||This p value is adjusted for multiple comparisons using the false discovery rate (FDR) approach and a p value \<0.05 is taken for significance.|t-test, 2 sided|||mir1978||||0.38
72533910|NCT01484691|144597014|SUPERIORITY||Mean Difference (Net)|4.53||||0.26|TWO_SIDED|||||This p value is adjusted for multiple comparisons using the false discovery rate (FDR) approach and a p value \<0.05 is taken for significance.|t-test, 2 sided|||mir1||||0.26
72533911|NCT01484691|144597014|SUPERIORITY||Mean Difference (Net)|4.52||||0.26|TWO_SIDED|||||This p value is adjusted for multiple comparisons using the false discovery rate (FDR) approach and a p value \<0.05 is taken for significance.|t-test, 2 sided|||mir107||||0.26
72626378|NCT00402987|144781755|SUPERIORITY_OR_OTHER_LEGACY||NNT at 12 hours|7.5||||||95.0|4.3|28.7||||||NNT is the inverse of the absolute risk reduction at 12 hours||28.7|4.3|
72533912|NCT01484691|144597014|SUPERIORITY||Mean Difference (Net)|3.57||||0.26|TWO_SIDED|||||This p value is adjusted for multiple comparisons using the false discovery rate (FDR) approach and a p value \<0.05 is taken for significance.|t-test, 2 sided|||mir128||||0.26
72533913|NCT01484691|144597014|SUPERIORITY||Mean Difference (Net)|-0.58||||0.87|TWO_SIDED|||||This p value is adjusted for multiple comparisons using the false discovery rate (FDR) approach and a p value \<0.05 is taken for significance.|t-test, 2 sided|||mir141||||0.87
72533914|NCT01484691|144597014|SUPERIORITY||Mean Difference (Net)|4.57||||0.29|TWO_SIDED|||||This p value is adjusted for multiple comparisons using the false discovery rate (FDR) approach and a p value \<0.05 is taken for significance.|t-test, 2 sided|||mir148b||||0.29
72533915|NCT01484691|144597014|SUPERIORITY||Mean Difference (Net)|1.56||||0.75|TWO_SIDED|||||This p value is adjusted for multiple comparisons using the false discovery rate (FDR) approach and a p value \<0.05 is taken for significance.|t-test, 2 sided|||mir181b||||0.75
72533916|NCT01484691|144597014|SUPERIORITY||Mean Difference (Net)|2.9||||0.36|TWO_SIDED|||||This p value is adjusted for multiple comparisons using the false discovery rate (FDR) approach and a p value \<0.05 is taken for significance.|t-test, 2 sided|||mir185||||0.36
72533917|NCT01484691|144597014|SUPERIORITY||Mean Difference (Net)|-0.36||||0.89|TWO_SIDED|||||This p value is adjusted for multiple comparisons using the false discovery rate (FDR) approach and a p value \<0.05 is taken for significance.|t-test, 2 sided|||mir194||||0.89
72533918|NCT01484691|144597014|SUPERIORITY||Mean Difference (Net)|2.48||||0.48|TWO_SIDED|||||This p value is adjusted for multiple comparisons using the false discovery rate (FDR) approach and a p value \<0.05 is taken for significance.|t-test, 2 sided|||mir19a||||0.48
72533919|NCT01484691|144597014|SUPERIORITY||Mean Difference (Net)|0.75||||0.87|TWO_SIDED|||||This p value is adjusted for multiple comparisons using the false discovery rate (FDR) approach and a p value \<0.05 is taken for significance.|t-test, 2 sided|||mir200a||||0.87
72533920|NCT01484691|144597014|SUPERIORITY||Mean Difference (Net)|2.78||||0.53|TWO_SIDED|||||This p value is adjusted for multiple comparisons using the false discovery rate (FDR) approach and a p value \<0.05 is taken for significance.|t-test, 2 sided|||mir22||||0.53
72533921|NCT01484691|144597014|SUPERIORITY||Mean Difference (Net)|1.91||||0.57|TWO_SIDED|||||This p value is adjusted for multiple comparisons using the false discovery rate (FDR) approach and a p value \<0.05 is taken for significance.|t-test, 2 sided|||mir223||||0.57
72533922|NCT01484691|144597014|SUPERIORITY||Mean Difference (Net)|4.27||||0.26|TWO_SIDED|||||This p value is adjusted for multiple comparisons using the false discovery rate (FDR) approach and a p value \<0.05 is taken for significance.|t-test, 2 sided|||mir23a||||0.26
72533923|NCT01484691|144597014|SUPERIORITY||Mean Difference (Net)|1.66||||0.75|TWO_SIDED|||||This p value is adjusted for multiple comparisons using the false discovery rate (FDR) approach and a p value \<0.05 is taken for significance.|t-test, 2 sided|||mir26a||||0.75
72533924|NCT01484691|144597014|SUPERIORITY||Mean Difference (Net)|-0.91||||0.89|TWO_SIDED|||||This p value is adjusted for multiple comparisons using the false discovery rate (FDR) approach and a p value \<0.05 is taken for significance.|t-test, 2 sided|||mir320b||||0.89
72533925|NCT01484691|144597014|SUPERIORITY||Mean Difference (Net)|3.32||||0.26|TWO_SIDED|||||This p value is adjusted for multiple comparisons using the false discovery rate (FDR) approach and a p value \<0.05 is taken for significance.|t-test, 2 sided|||mir598||||0.26
72533926|NCT01484691|144597014|SUPERIORITY||Mean Difference (Net)|-0.99||||0.87|TWO_SIDED|||||This p value is adjusted for multiple comparisons using the false discovery rate (FDR) approach and a p value \<0.05 is taken for significance.|t-test, 2 sided|||mir720||||0.87
72533927|NCT01484691|144597014|SUPERIORITY||Mean Difference (Net)|-0.75||||0.74|TWO_SIDED|||||This p value is adjusted for multiple comparisons using the false discovery rate (FDR) approach and a p value \<0.05 is taken for significance.|t-test, 2 sided|||mir1915||||0.74
72533928|NCT01484691|144597014|SUPERIORITY||Mean Difference (Net)|3.77||||0.36|TWO_SIDED|||||This p value is adjusted for multiple comparisons using the false discovery rate (FDR) approach and a p value \<0.05 is taken for significance.|t-test, 2 sided|||mir1978||||0.36
72533929|NCT01738672|144597040|OTHER|||||||0.16|||||||t-test, 2 sided|||||||0.16
72533930|NCT01738672|144597041|OTHER|||||||0.73|||||||t-test, 2 sided|||||||0.73
72533931|NCT01738672|144597042|OTHER|||||||0.56|||||||t-test, 2 sided|||||||0.56
72533932|NCT00736840|144597046|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Provided above|Sensitivity|0.74|STANDARD_ERROR_OF_MEAN|0.0363||0.0924|TWO_SIDED|95.0|0.6607|0.8809|||Exact binomial test|||The null hypothesis was sensitivity lower than 0.8. We assumed a sensitivity of 0.89 and required a power of 90% to test the hypothesis at a 5% level of significance, and calculated that 173 cirrhotic and 241 non-cirrhotic subjects were needed (for a one-sample binomial test of outcome versus constant).||0.8809|0.6607|0.0924
72533933|NCT00736840|144597047|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Sample size was calculated to enable the testing of both study hypotheses (together) with at least 80% power. Our best estimate of sensitivity of the HIS diagnosis in the population, was 0.9 and its specificity 0.79. Requiring a power of 90% for each of the hypotheses and a 5% level of significance, to test the null hypotheses 173 cirrhotic and 241 non-cirrhotic subjects were needed.Therefore a total of at least 414 subjects were required.|AUC ROC|0.785|STANDARD_ERROR_OF_MEAN|0.0485|<|0.0001|TWO_SIDED|95.0|0.737|0.834|||Regression, Logistic|||||0.834|0.737|<0.0001
72533934|NCT01314261|144597052|SUPERIORITY_OR_OTHER|||||||0.336|TWO_SIDED|||||No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.|Regression, Logistic|Treatment group, baseline HCV RNA level, HCV subgenotype (1a or 1b), and interleukin 28B genotype (CC or non-CC) were predictors.||Ten participants in an ABT-267 arm and nine participants in the placebo arm would provide 84% power using Fisher's exact test with two-sided significance level of 0.05 to detect a difference of approximately 70% between the two arms.||||0.336
72533935|NCT01314261|144597052|SUPERIORITY_OR_OTHER|||||||0.171|TWO_SIDED|||||No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.|Regression, Logistic|Treatment group, baseline HCV RNA level, HCV sub-genotype (1a or 1b), and interleukin 28B genotype (CC or non-CC) were predictors.||Ten participants in an ABT-267 arm and nine participants in the placebo arm would provide 84% power using Fisher's exact test with two-sided significance level of 0.05 to detect a difference of approximately 70% between the two arms.||||0.171
72626379|NCT00402987|144781755|SUPERIORITY_OR_OTHER_LEGACY||NNT at 12 hours|5.0||||||95.0|3.0|16.7||||||NNT is the inverse of the absolute risk reduction at 12 hours||16.7|3.0|
72408059|NCT03238911|144324434|SUPERIORITY||Mean Difference (Final Values)|0.48||||0.0016|TWO_SIDED|95.0|0.19|0.77|||Mixed model for repeated measures|||"Day 21~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||0.77|0.19|0.0016
72408060|NCT03238911|144324434|SUPERIORITY||Mean Difference (Final Values)|0.42||||0.0185|TWO_SIDED|95.0|0.07|0.76|||Mixed model for repeated measures|||"Day 35~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||0.76|0.07|0.0185
72533936|NCT01314261|144597052|SUPERIORITY_OR_OTHER|||||||0.03|TWO_SIDED|||||No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.|Regression, Logistic|Treatment group, baseline HCV RNA level, HCV sub-genotype (1a or 1b), and interleukin 28B genotype (CC or non-CC) were predictors.||Ten participants in an ABT-267 arm and nine participants in the placebo arm would provide 84% power using Fisher's exact test with two-sided significance level of 0.05 to detect a difference of approximately 70% between the two arms.||||0.030
72533937|NCT01314261|144597053|SUPERIORITY_OR_OTHER|||||||0.102|TWO_SIDED|||||No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.|Cochran-Mantel-Haenszel|Controlled for interleukin 28B genotype (CC or non-CC), HCV sub-genotype (1a or 1b), and baseline HCV RNA levels (≤ median or \> median).||||||0.102
72533938|NCT01314261|144597053|SUPERIORITY_OR_OTHER|||||||0.362|TWO_SIDED|||||No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.|Cochran-Mantel-Haenszel|Controlled for interleukin 28B genotype (CC or non-CC), HCV sub-genotype (1a or 1b), and baseline HCV RNA levels (≤ median or \> median).||||||0.362
72533939|NCT01314261|144597053|SUPERIORITY_OR_OTHER|||||||0.079|TWO_SIDED|||||No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.|Cochran-Mantel-Haenszel|Controlled for interleukin 28B genotype (CC or non-CC), HCV sub-genotype (1a or 1b), and baseline HCV RNA levels (≤ median or \> median).||||||0.079
72533940|NCT01314261|144597057|SUPERIORITY_OR_OTHER|||||||0.083|TWO_SIDED|||||No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.|Cochran-Mantel-Haenszel|Controlled for interleukin 28B genotype (CC or non-CC), HCV sub-genotype (1a or 1b), and baseline HCV RNA levels (≤ median or \> median).||||||0.083
72533941|NCT01314261|144597057|SUPERIORITY_OR_OTHER|||||||0.515|TWO_SIDED|||||No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.|Cochran-Mantel-Haenszel|Controlled for interleukin 28B genotype (CC or non-CC), HCV sub-genotype (1a or 1b), and baseline HCV RNA levels (≤ median or \> median).||||||0.515
72533942|NCT01314261|144597057|SUPERIORITY_OR_OTHER|||||||0.221|TWO_SIDED|||||No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.|Cochran-Mantel-Haenszel|Controlled for interleukin 28B genotype (CC or non-CC), HCV sub-genotype (1a or 1b), and baseline HCV RNA levels (≤ median or \> median).||||||0.221
72533943|NCT01314261|144597058|SUPERIORITY_OR_OTHER|||||||0.155|TWO_SIDED|||||No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.|Regression, Logistic|Treatment group, baseline HCV RNA level, HCV sub-genotype (1a or 1b), and interleukin 28B genotype (CC or non-CC) were predictors.||||||0.155
72533944|NCT01314261|144597058|SUPERIORITY_OR_OTHER|||||||0.214|TWO_SIDED|||||No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.|Regression, Logistic|Treatment group, baseline HCV RNA level, HCV sub-genotype (1a or 1b), and interleukin 28B genotype (CC or non-CC) were predictors.||||||0.214
72533945|NCT01314261|144597058|SUPERIORITY_OR_OTHER|||||||0.231|TWO_SIDED|||||No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.|Regression, Logistic|Treatment group, baseline HCV RNA level, HCV sub-genotype (1a or 1b), and interleukin 28B genotype (CC or non-CC) were predictors.||||||0.231
72626380|NCT00402987|144781756|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|3.77|||<|0.001||95.0|1.9|7.6||Analysis for 2 hours \>=35% gone|Regression, Logistic|Treatment as a factor||||7.6|1.9|<0.001
72533946|NCT01314261|144597059|SUPERIORITY_OR_OTHER|||||||0.127|TWO_SIDED|||||No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.|Regression, Logistic|Treatment group, baseline HCV RNA level, HCV sub-genotype (1a or 1b), and interleukin 28B genotype (CC or non-CC) were predictors.||||||0.127
72533947|NCT01314261|144597059|SUPERIORITY_OR_OTHER|||||||0.328|TWO_SIDED|||||No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.|Regression, Logistic|Treatment group, baseline HCV RNA level, HCV sub-genotype (1a or 1b), and interleukin 28B genotype (CC or non-CC) were predictors.||||||0.328
72533948|NCT01314261|144597059|SUPERIORITY_OR_OTHER|||||||0.166|TWO_SIDED|||||No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.|Regression, Logistic|Treatment group, baseline HCV RNA level, HCV sub-genotype (1a or 1b), and interleukin 28B genotype (CC or non-CC) were predictors.||||||0.166
72533949|NCT01314261|144597060|SUPERIORITY_OR_OTHER|||||||0.007|TWO_SIDED|||||No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.|Log Rank|||||||0.007
72533950|NCT01314261|144597060|SUPERIORITY_OR_OTHER|||||||0.029|TWO_SIDED|||||No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.|Log Rank|||||||0.029
72533951|NCT01314261|144597060|SUPERIORITY_OR_OTHER|||||||0.105|TWO_SIDED|||||No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.|Log Rank|||||||0.105
72626381|NCT00402987|144781756|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.72||||0.005||95.0|1.3|5.5||Analysis for 2 hours \>=35% gone|Regression, Logistic|Treatment as a factor||||5.5|1.3|0.005
72626382|NCT00402987|144781756|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.72||||0.286||95.0|0.4|1.3||Analysis for 2 hours \>=35% gone|Regression, Logistic|Treatment as a factor||||1.3|0.4|0.286
72626383|NCT00402987|144781756|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|3.37||||0.001||95.0|1.6|7.1||Analysis for 6 hours \>=35% gone|Regression, Logistic|Treatment as a factor||||7.1|1.6|0.001
72626384|NCT00402987|144781756|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|3.05||||0.004||95.0|1.4|6.5||Analysis for 6 hours \>=35% gone|Regression, Logistic|Treatment as a factor||||6.5|1.4|0.004
72626385|NCT00402987|144781756|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.9||||0.752||95.0|0.5|1.7||Analysis for 6 hours \>=35% gone|Regression, Logistic|Treatment as a factor||||1.7|0.5|0.752
72408061|NCT03238911|144324435|SUPERIORITY||Mean Difference (Final Values)|-14.84||||0.1922|TWO_SIDED|95.0|-37.26|7.57|||Mixed model for repeated measures|||"Day 1~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||7.57|-37.26|0.1922
72533952|NCT01314261|144597063|SUPERIORITY_OR_OTHER|||||||0.028|TWO_SIDED|||||No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.|Regression, Logistic|Treatment group, baseline HCV RNA level, HCV sub-genotype (1a or 1b), and interleukin 28B genotype (CC or non-CC) were predictors.||||||0.028
72533953|NCT01314261|144597063|SUPERIORITY_OR_OTHER|||||||0.051|TWO_SIDED|||||No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.|Regression, Logistic|Treatment group, baseline HCV RNA level, HCV sub-genotype (1a or 1b), and interleukin 28B genotype (CC or non-CC) were predictors.||||||0.051
72533954|NCT01314261|144597063|SUPERIORITY_OR_OTHER|||||||0.021|TWO_SIDED|||||No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.|Regression, Logistic|Treatment group, baseline HCV RNA level, HCV sub-genotype (1a or 1b), and interleukin 28B genotype (CC or non-CC) were predictors.||||||0.021
72533955|NCT00422227|144597075|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA|||||||<0.001
72533956|NCT00422227|144597076|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Fisher Exact|||ACR 20||||<0.001
72533957|NCT00422227|144597076|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Fisher Exact|||ACR 50||||<0.001
72533958|NCT00422227|144597076|SUPERIORITY_OR_OTHER|||||||0.009||95.0|||||Fisher Exact|||ACR 70||||0.009
72533959|NCT00422227|144597077|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Fisher Exact|||Low Disease (DAS28 \<3.2)||||<0.001
72533960|NCT00422227|144597077|SUPERIORITY_OR_OTHER|||||||0.069||95.0|||||Fisher Exact|||Remission (DAS28 \<2.6)||||0.069
72533961|NCT00422227|144597078|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||||||<0.001
72533962|NCT00422227|144597079|SUPERIORITY_OR_OTHER|||||||0.003||95.0|||||Fisher Exact|||||||0.003
72533963|NCT00422227|144597080|SUPERIORITY_OR_OTHER|||||||0.003||95.0|||||Fisher Exact|||≥0.6||||0.003
72533964|NCT00422227|144597080|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||Fisher Exact|||≥1.2||||0.001
72533965|NCT00422227|144597081|SUPERIORITY_OR_OTHER|||||||0.014||95.0|||||ANCOVA|||Painful Joints at Week 16||||0.014
72533966|NCT00422227|144597081|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Swollen Joints at Week 16||||<0.001
72533967|NCT00422227|144597082|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Physician Global Assessment Week 16||||<0.001
72533968|NCT00422227|144597082|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Subject Global Assessment Week 16||||<0.001
72533969|NCT00422227|144597083|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Week 16||||<0.001
72533970|NCT00422227|144597084|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||General Health Week 16||||<0.001
72533971|NCT00422227|144597084|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Pain Week 16||||<0.001
72533972|NCT00422227|144597084|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||ANCOVA|||Fatigue Week 16||||0.001
72533973|NCT01678794|144597085|SUPERIORITY|||||||0.26|||||||t-test, 2 sided|||||||0.26
72533974|NCT01678794|144597086|SUPERIORITY|||||||0.67|||||||t-test, 2 sided|||||||0.67
72533975|NCT02260804|144597102|EQUIVALENCE|The equivalence margin of ±17% was predefined.|Difference in proportion|1.8|||||TWO_SIDED|90.0|-6.43|10.2||||||||10.2|-6.43|
72533976|NCT01018680|144597116|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.91|||<|0.001||95.0||||A 0.05 level of significance was pre-specified for use in treatment group comparisons.|Mixed Models Analysis|In Mixed Models Analysis, degrees of freedom were estimated using the Kenward-Rogers approximation.||Using a 1:1 ratio of allocation to treatment, a 2-tailed 0.05 level of significance and 80% power, 253 participants per arm had been estimated to be adequate to assess an effect size of 0.25, based on a 2-sample Student's t-test. This derived estimate was increased slightly to 261 participants per arm to account for extremely early discontinuation that would have led to exclusion from the efficacy analysis in a small number of participants (approximately 3%).||||<0.001
72533977|NCT01018680|144597117|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.59|||<|0.001||95.0||||First gated secondary outcome measure. Gatekeeper strategy (Westfall and Krishen 2001) controlled experiment-wise type I error for 2 secondary outcomes with sequential comparisons of treatments until outcome failed to be significant (p\>0.05).|Mixed Models Analysis|In Mixed Models Analysis, degrees of freedom were estimated using the Kenward-Rogers approximation.||||||<0.001
72533978|NCT01018680|144597118|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.84|||<|0.001||95.0||||WOMAC Physical Disability Score p-value. Second gated secondary outcome measure. Gatekeeper strategy controlled experiment-wise type I error for 2 secondary outcomes with sequential treatment comparisons until outcome failed significance (p\>0.05).|Mixed Models Analysis|In Mixed Models Analysis, degrees of freedom were estimated using the Kenward-Rogers approximation.||||||<0.001
72533979|NCT01018680|144597118|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.28|||<|0.001||95.0||||This is the p-value for the WOMAC Pain Score. A 0.05 level of significance was pre-specified for use in treatment group comparisons.|Mixed Models Analysis|In Mixed Models Analysis, degrees of freedom were estimated using the Kenward-Rogers approximation.||||||<0.001
72533980|NCT01018680|144597118|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.42||||0.004||95.0||||This is the p-value for WOMAC Stiffness Score. A 0.05 level of significance was pre-specified for use in treatment group comparisons.|Mixed Models Analysis|In Mixed Models Analysis, degrees of freedom were estimated using the Kenward-Rogers approximation.||||||0.004
72626386|NCT00402987|144781756|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|4.57|||<|0.001||95.0|1.9|10.7||Analysis for 2 hours \>=50% gone|Regression, Logistic|Treatment as a factor||||10.7|1.9|<0.001
72408062|NCT03238911|144324435|SUPERIORITY||Mean Difference (Final Values)|-18.28||||0.5601|TWO_SIDED|95.0|-80.24|43.68|||Mixed model for repeated measures|||"Day 7~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||43.68|-80.24|0.5601
72533981|NCT01018680|144597119|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8|||<|0.001||95.0||||This is the p-value for Night Pain Intensity. A 0.05 level of significance was pre-specified for use in treatment group comparisons.|Mixed Models Analysis|In Mixed Models Analysis, degrees of freedom were estimated using the Kenward-Rogers approximation.||||||<0.001
72533982|NCT01018680|144597119|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.03|||<|0.001||95.0||||This is the p-value for Worst Pain Intensity. A 0.05 level of significance was pre-specified for use in treatment group comparisons.|Mixed Models Analysis|In Mixed Models Analysis, degrees of freedom were estimated using the Kenward-Rogers approximation.||||||<0.001
72533983|NCT01018680|144597120|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.08|||<|0.001||95.0||||This is the p-value for BPI-S for Worst Pain. A 0.05 level of significance was pre-specified for use in treatment group comparisons.|Mixed Models Analysis|In Mixed Models Analysis, degrees of freedom were estimated using the Kenward-Rogers approximation.||||||<0.001
72533984|NCT01018680|144597120|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7|||<|0.001||95.0||||This is the p-value for BPI-S for Least Pain. A 0.05 level of significance was pre-specified for use in treatment group comparisons.|Mixed Models Analysis|In Mixed Models Analysis, degrees of freedom were estimated using the Kenward-Rogers approximation.||||||<0.001
72533985|NCT01018680|144597120|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.95|||<|0.001||95.0||||This is the p-value for BPI-S for Average Pain. A 0.05 level of significance was pre-specified for use in treatment group comparisons.|Mixed Models Analysis|In Mixed Models Analysis, degrees of freedom were estimated using the Kenward-Rogers approximation.||||||<0.001
72533986|NCT01018680|144597120|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.71|||<|0.001||95.0||||This is the p-value for BPI-S for Pain Right Now. A 0.05 level of significance was pre-specified for use in treatment group comparisons.|Mixed Models Analysis|In Mixed Models Analysis, degrees of freedom were estimated using the Kenward-Rogers approximation.||||||<0.001
72533987|NCT01018680|144597120|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.97|||<|0.001||95.0||||This is the p-value for BPI-I for General Activity. A 0.05 level of significance was pre-specified for use in treatment group comparisons.|Mixed Models Analysis|In Mixed Models Analysis, degrees of freedom were estimated using the Kenward-Rogers approximation.||||||<0.001
72533988|NCT01018680|144597120|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.72|||<|0.001||95.0||||This is the p-value for BPI-I for Mood. A 0.05 level of significance was pre-specified for use in treatment group comparisons.|Mixed Models Analysis|In Mixed Models Analysis, degrees of freedom were estimated using the Kenward-Rogers approximation.||||||<0.001
72533989|NCT01018680|144597120|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.95|||<|0.001||95.0||||This is the p-value for BPI-I for Walking Ability. A 0.05 level of significance was pre-specified for use in treatment group comparisons.|Mixed Models Analysis|In Mixed Models Analysis, degrees of freedom were estimated using the Kenward-Rogers approximation.||||||<0.001
72533990|NCT01018680|144597120|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.85|||<|0.001||95.0||||This is the p-value for BPI-I for Normal Work. A 0.05 level of significance was pre-specified for use in treatment group comparisons.|Mixed Models Analysis|In Mixed Models Analysis, degrees of freedom were estimated using the Kenward-Rogers approximation.||||||<0.001
72572478|NCT01674647|144672495|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.5|||||TWO_SIDED|95.0|0.16|1.55|||no statistical test performed||Crude estimate of the cumulative incidence for rivaroxaban (Xarelto, BAY59-7939): 0.61% (0.27% - 1.29%). Crude estimate of the cumulative incidence for Vitamin K antagonist (VKA): 1.22% (0.53% - 2.51%).|Descriptive comparison of crude estimates of the cumulative incidence and estimation of risk ratio, all with 95% confidence intervals||1.55|0.16|
72572479|NCT01674647|144672500|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.01|||||TWO_SIDED|95.0|0.18|5.47|||no statistical test performed||Crude estimate of the cumulative incidence for rivaroxaban (Xarelto, BAY59-7939): 0.41% (0.14% - 1.02%). Crude estimate of the cumulative incidence for Vitamin K antagonist (VKA): 0.41% (0.07% - 1.41%).|Descriptive comparison of crude estimates of the cumulative incidence and estimation of risk ratio, all with 95% confidence intervals||5.47|0.18|
72533991|NCT01018680|144597120|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.69|||<|0.001||95.0||||This is the p-value for BPI-I for Relations with Others. A 0.05 level of significance was pre-specified for use in treatment group comparisons.|Mixed Models Analysis|In Mixed Models Analysis, degrees of freedom were estimated using the Kenward-Rogers approximation.||||||<0.001
72533992|NCT01018680|144597120|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.68|||<|0.001||95.0||||This is the p-value for BPI-I for Sleep. A 0.05 level of significance was pre-specified for use in treatment group comparisons.|Mixed Models Analysis|In Mixed Models Analysis, degrees of freedom were estimated using the Kenward-Rogers approximation.||||||<0.001
72533993|NCT01018680|144597120|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.77|||<|0.001||95.0||||This is the p-value for BPI-I for Enjoyment of Life. A 0.05 level of significance was pre-specified for use in treatment group comparisons.|Mixed Models Analysis|In Mixed Models Analysis, degrees of freedom were estimated using the Kenward-Rogers approximation.||||||<0.001
72626387|NCT00402987|144781756|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|3.68||||0.003||95.0|1.6|8.7||Analysis for 2 hours \>=50% gone|Regression, Logistic|Treatment as a factor||||8.7|1.6|0.003
72572480|NCT01674647|144672501|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.84|||||TWO_SIDED|95.0|0.2|3.49|||no statistical test performed||Crude estimate of the cumulative incidence for rivaroxaban (Xarelto, BAY59-7939): 0.51% (0.20% - 1.17%). Crude estimate of the cumulative incidence for Vitamin K antagonist (VKA): 0.61% (0.17% - 1.72%).|Descriptive comparison of crude estimates of the cumulative incidence and estimation of risk ratio, all with 95% confidence intervals||3.49|0.20|
72572481|NCT04156620|144672505|SUPERIORITY||Marginal difference|17.91|||<|0.0001|TWO_SIDED|95.0|10.12|25.71|||Regression, Logistic|||Week 16||25.71|10.12|<0.0001
72572482|NCT04156620|144672506|SUPERIORITY||Marginal difference|20.45|||<|0.0001|TWO_SIDED|95.0|14.45|26.44|||Regression, Logistic|||||26.44|14.45|<0.0001
72626388|NCT00402987|144781756|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.81||||0.511||95.0|0.4|1.5||Analysis for 2 hours \>=50% gone|Regression, Logistic|Treatment as a factor||||1.5|0.4|0.511
72626389|NCT00402987|144781756|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|3.05||||0.009||95.0|1.3|7.0||Analysis for 6 hours \>=50% gone|Regression, Logistic|Treatment as a factor||||7.0|1.3|0.009
72626390|NCT00402987|144781756|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.88||||0.014||95.0|1.2|6.7||Analysis for 6 hours \>=50% gone|Regression, Logistic|Treatment as a factor||||6.7|1.2|0.014
72626391|NCT00402987|144781756|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.94||||0.863||95.0|0.5|1.9||Analysis for 6 hours \>=50% gone|Regression, Logistic|Treatment as a factor||||1.9|0.5|0.863
72626392|NCT00402987|144781757|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.92||||0.004||95.0|1.4|6.1||12 hours \>=35% gone|Regression, Logistic|Treatment as a factor||||6.1|1.4|0.004
72626393|NCT00402987|144781757|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.37||||0.052||95.0|1.0|5.7||12 hours \>=35% gone|Regression, Logistic|Treatment as a factor||||5.7|1.0|0.052
72626394|NCT00402987|144781757|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.13||||0.095||95.0|0.9|5.1||12 hours \>=35% gone|Regression, Logistic|Treatment as a factor||||5.1|0.9|0.095
72533994|NCT01018680|144597120|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.84|||<|0.001||95.0||||This is the p-value for BPI-I for Mean Interference Score. A 0.05 level of significance was pre-specified for use in treatment group comparisons.|Mixed Models Analysis|In Mixed Models Analysis, degrees of freedom were estimated using the Kenward-Rogers approximation.||||||<0.001
72572483|NCT04156620|144672507|SUPERIORITY||LS mean change|-1.01|STANDARD_ERROR_OF_MEAN|0.189|<|0.0001|TWO_SIDED|95.0|-1.38|-0.64|||Mixed Models Analysis|||Week 16||-0.64|-1.38|<0.0001
72572484|NCT04156620|144672508|SUPERIORITY||Marginal difference|22.15|||<|0.0001|TWO_SIDED|95.0|14.36|29.95|||Regression, Logistic|||||29.95|14.36|<0.0001
72626395|NCT00402987|144781757|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.38||||0.431||95.0|0.6|3.0||12 hours \>=35% gone|Regression, Logistic|Treatment as a factor||||3.0|0.6|0.431
72533995|NCT01018680|144597121|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.35|||<|0.001||95.0||||A 0.05 level of significance was pre-specified for use in treatment group comparisons.|Mixed Models Analysis|In Mixed Models Analysis, degrees of freedom were estimated using the Kenward-Rogers approximation.||||||<0.001
72533996|NCT01018680|144597122|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.17|||<|0.001||95.0||||A 0.05 level of significance was pre-specified for use in treatment group comparisons.|Mixed Models Analysis|In Mixed Models Analysis, degrees of freedom were estimated using the Kenward-Rogers approximation.||||||<0.001
72533997|NCT01018680|144597123|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.83||||0.449||95.0||||This is the p-value for the BPOMS Total Score. A 0.05 level of significance was pre-specified for use in treatment group comparisons.|Mixed Models Analysis|In Mixed Models Analysis, degrees of freedom were estimated using the Kenward-Rogers approximation.||||||0.449
72533998|NCT01018680|144597123|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.28||||0.265||95.0||||This is the p-value for the BPOMS Tension-Anxiety Score. A 0.05 level of significance was pre-specified for use in treatment group comparisons.|Mixed Models Analysis|In Mixed Models Analysis, degrees of freedom were estimated using the Kenward-Rogers approximation.||||||0.265
72533999|NCT01018680|144597123|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.34||||0.18||95.0||||This is the p-value for the BPOMS Depression-Dejection Score. A 0.05 level of significance was pre-specified for use in treatment group comparisons.|Mixed Models Analysis|In Mixed Models Analysis, degrees of freedom were estimated using the Kenward-Rogers approximation.||||||0.180
72572485|NCT04156620|144672509|SUPERIORITY||LS mean change|-0.94|STANDARD_ERROR_OF_MEAN|0.194|<|0.0001|TWO_SIDED|95.0|-1.33|-0.56|||Mixed Models Analysis|||Week 16||-0.56|-1.33|<0.0001
72572486|NCT04156620|144672510|SUPERIORITY||LS mean change|3.01|STANDARD_ERROR_OF_MEAN|0.615|<|0.0001|TWO_SIDED|95.0|1.8|4.22|||Mixed Models Analysis|||Week 16||4.22|1.80|<0.0001
72572487|NCT04156620|144672511|SUPERIORITY||LS mean change|-1.77|STANDARD_ERROR_OF_MEAN|0.373|<|0.0001|TWO_SIDED|95.0|-2.51|-1.04|||Mixed Models Analysis|||Week 16||-1.04|-2.51|<0.0001
72572488|NCT04156620|144672512|SUPERIORITY||Relative LS mean change|0.44|||<|0.0001|TWO_SIDED|95.0|0.37|0.51|||Mixed Models Analysis|||Week 16||0.51|0.37|<0.0001
72626396|NCT00402987|144781757|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.23||||0.602||95.0|0.6|2.7||12 hours \>=35% gone|Regression, Logistic|Treatment as a factor||||2.7|0.6|0.602
72626397|NCT00402987|144781757|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.12||||0.814||95.0|0.4|2.8||12 hours \>=35% gone|Regression, Logistic|Treatment as a factor||||2.8|0.4|0.814
72626398|NCT00402987|144781757|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.88||||0.014||95.0|1.2|6.7||12 hours \>=50% gone|Regression, Logistic|Treatment as a factor||||6.7|1.2|0.014
72626399|NCT00402987|144781757|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|3.23||||0.016||95.0|1.2|8.4||12 hours \>=50% gone|Regression, Logistic|Treatment as a factor||||8.4|1.2|0.016
72626400|NCT00402987|144781757|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.54||||0.063||95.0|0.9|6.8||12 hours \>=50% gone|Regression, Logistic|Treatment as a factor||||6.8|0.9|0.063
72626401|NCT00402987|144781757|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.13||||0.775||95.0|0.5|2.7||12 hours \>=50% gone|Regression, Logistic|Treatment as a factor||||2.7|0.5|0.775
72626402|NCT00402987|144781757|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.89||||0.779||95.0|0.4|2.0||12 hours \>=50% gone|Regression, Logistic|Treatment as a factor||||2.0|0.4|0.779
72626403|NCT00402987|144781757|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.27||||0.624||95.0|0.5|3.3||12 hours \>=50% gone|Regression, Logistic|Treatment as a factor||||3.3|0.5|0.624
72626404|NCT00402987|144781758|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001||95.0||||Analysis for meaningful Relief at 2 hours|Regression, Logistic|Treatment as a factor||||||0.001
72572489|NCT04156620|144672513|SUPERIORITY||Marginal difference|23.41|||<|0.0001|TWO_SIDED|95.0|15.61|31.66|||Regression, Logistic|||||31.66|15.61|<0.0001
72572490|NCT04156620|144672514|SUPERIORITY||Marginal difference|12.58|||<|0.0001|TWO_SIDED|95.0|7.96|17.19|||Regression, Logistic|||Week 16||17.19|7.96|<0.0001
72572491|NCT04156620|144672515|SUPERIORITY||Marginal difference|10.56|||<|0.0001|TWO_SIDED|95.0|5.64|15.47|||Regression, Logistic|||||15.47|5.64|<0.0001
72572492|NCT04156620|144672516|SUPERIORITY||LS mean change|-0.66|STANDARD_ERROR_OF_MEAN|0.292||0.0234|TWO_SIDED|95.0|-1.24|-0.09|||Regression, Logistic|||||-0.09|-1.24|0.0234
72534000|NCT01018680|144597123|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.52||||0.041||95.0||||This is the p-value for the BPOMS Anger-Hostility Score. 0.05 level of significance was pre-specified for use in treatment group comparisons.|Mixed Models Analysis|In Mixed Models Analysis, degrees of freedom were estimated using the Kenward-Rogers approximation.||||||0.041
72534001|NCT01018680|144597123|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.37||||0.356||95.0||||This is the p-value for the BPOMS Vigor-Activity Score. A 0.05 level of significance was pre-specified for use in treatment group comparisons.|Mixed Models Analysis|In Mixed Models Analysis, degrees of freedom were estimated using the Kenward-Rogers approximation.||||||0.356
72572493|NCT01753336|144672519|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-8.0|STANDARD_DEVIATION|8.94|||TWO_SIDED|95.0|-9.79|-6.28||||||Cycle 1-Day 1 vs Cycle 1-Week 4. The mean difference in the TWSTRS total scores from treatment cycle baseline (Day 1) at the Week 4 visit for Treatment Cycle 1 is presented.||-6.28|-9.79|
72534002|NCT01018680|144597123|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.06||||0.862||95.0||||This is the p-value for the BPOMS Fatigue-Inertia Score. A 0.05 level of significance was pre-specified for use in treatment group comparisons.|Mixed Models Analysis|In Mixed Models Analysis, degrees of freedom were estimated using the Kenward-Rogers approximation.||||||0.862
72534003|NCT01018680|144597123|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.03||||0.883||95.0||||This is the p-value for the BPOMS Confusion-Bewilderment Score. A 0.05 level of significance was pre-specified for use in treatment group comparisons.|Mixed Models Analysis|In Mixed Models Analysis, degrees of freedom were estimated using the Kenward-Rogers approximation.||||||0.883
72572494|NCT01753336|144672519|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.0|STANDARD_DEVIATION|11.68|||TWO_SIDED|95.0|-7.36|-2.68||||||Cycle 1-Day 1 vs Cycle 1-Week 12. The mean difference in the TWSTRS total scores from treatment cycle baseline (Day 1) at the Week 12 visit for Treatment Cycle 1 is presented.||-2.68|-7.36|
72572495|NCT01753336|144672519|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.9|STANDARD_DEVIATION|7.29|||TWO_SIDED|95.0|-7.42|-4.47||||||Cycle 2-Day 1 vs Cycle 2-Week 4. The mean difference in the TWSTRS total scores from treatment cycle baseline (Day 1) at the Week 4 visit for Treatment Cycle 2 is presented.||-4.47|-7.42|
72572496|NCT01753336|144672519|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.8|STANDARD_DEVIATION|7.49|||TWO_SIDED|95.0|-3.37|-0.27||||||Cycle 2-Day 1 vs Cycle 2-Week 12. The mean difference in the TWSTRS total scores from treatment cycle baseline (Day 1) at the Week 12 visit for Treatment Cycle 2 is presented.||-0.27|-3.37|
72534004|NCT01018680|144597124|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.0||||0.083||95.0||||A 0.05 level of significance was pre-specified for use in treatment group comparisons.|Mixed Models Analysis|In Mixed Models Analysis, degrees of freedom were estimated using the Kenward-Rogers approximation.||||||0.083
72534005|NCT01018680|144597125|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||A 0.05 level of significance was pre-specified for use in treatment group comparisons.|Fisher Exact|||||||<0.001
72572497|NCT01753336|144672519|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.1|STANDARD_DEVIATION|9.03|||TWO_SIDED|95.0|-5.99|-2.2||||||Cycle 3-Day 1 vs Cycle 3-Week 4. The mean difference in the TWSTRS total scores from treatment cycle baseline (Day 1) at the Week 4 visit for Treatment Cycle 3 was determined.||-2.20|-5.99|
72572498|NCT01753336|144672519|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.1|STANDARD_DEVIATION|9.42|||TWO_SIDED|95.0|-3.11|0.81||||||Cycle 3-Day 1 vs Cycle 3-Week 12. The mean difference in the TWSTRS total scores from treatment cycle baseline (Day 1) at the Week 12 visit for Treatment Cycle 3 was determined.||0.81|-3.11|
72572499|NCT01753336|144672520|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-11.5|STANDARD_DEVIATION|9.74|||TWO_SIDED|95.0|-13.38|-9.56||||||Pretreatment baseline vs Cycle 1-Week 4. The mean difference in the TWSTRS total scores from baseline (pretreatment measurement before receiving Dysport® in Study 169 or for subjects who received placebo in Study 169, baseline was Day 1 of Cycle 1 of Study 170) at the Week 4 visit for Treatment Cycle 1 is presented.||-9.56|-13.38|
72572500|NCT01753336|144672520|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-8.9|STANDARD_DEVIATION|10.89|||TWO_SIDED|95.0|-11.08|-6.71||||||Pretreatment baseline vs Cycle 1-Week 12. The mean difference in the TWSTRS total scores from baseline (pretreatment measurement before receiving Dysport® in Study 169 or for subjects who received placebo in Study 169, baseline was Day 1 of Cycle 1 of Study 170) at the Week 12 visit for treatment Cycle 1 is presented.||-6.71|-11.08|
72572501|NCT01753336|144672520|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-14.4|STANDARD_DEVIATION|11.43|||TWO_SIDED|95.0|-16.74|-12.11||||||Pretreatment baseline vs Cycle 2-Week 4. The mean difference in the TWSTRS total scores from baseline (pretreatment measurement before receiving Dysport® in Study 169 or for subjects who received placebo in Study 169, baseline was Day 1 of Cycle 1 of Study 170) at the Week 4 visit for Treatment Cycle 2 is presented.||-12.11|-16.74|
72572502|NCT01753336|144672520|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-10.6|STANDARD_DEVIATION|11.33|||TWO_SIDED|95.0|-12.92|-8.22||||||Pretreatment baseline vs Cycle 2-Week 12. The mean difference in the TWSTRS total scores from baseline (pretreatment measurement before receiving Dysport® in Study 169 or for subjects who received placebo in Study 169, baseline was Day 1 of Cycle 1 of Study 170) at the Week 12 visit for Treatment Cycle 2 is presented.||-8.22|-12.92|
72572503|NCT01753336|144672520|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-14.6|STANDARD_DEVIATION|12.19|||TWO_SIDED|95.0|-17.18|-12.1||||||Pretreatment baseline vs Cycle 3-Week 4. The mean difference in the TWSTRS total scores from baseline (pretreatment measurement before receiving Dysport® in Study 169 or for subjects who received placebo in Study 169, baseline was Day 1 of Cycle 1 of Study 170) at the Week 4 visit for Treatment Cycle 3 is presented.||-12.10|-17.18|
72572504|NCT01753336|144672520|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-11.7|STANDARD_DEVIATION|11.17|||TWO_SIDED|95.0|-14.02|-9.39||||||Pretreatment baseline vs Cycle 3-Week 12. The mean difference in the TWSTRS total scores from baseline (pretreatment measurement before receiving Dysport® in Study 169 or for subjects who received placebo in Study 169, baseline was Day 1 of Cycle 1 of Study 170) at the Week 12 visit for Treatment Cycle 3 is presented.||-9.39|-14.02|
72572505|NCT01753336|144672522|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.5|STANDARD_DEVIATION|4.95|||TWO_SIDED|95.0|-4.46|-2.52||||||Cycle 1-Day 1 vs Cycle 1-Week 4. The mean difference in the TWSTRS severity subscale scores from treatment cycle baseline (Day 1) at the Week 4 visit for Treatment Cycle 1 was determined.||-2.52|-4.46|
72572506|NCT01753336|144672522|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.8|STANDARD_DEVIATION|5.24|||TWO_SIDED|95.0|-2.81|-0.7||||||Cycle 1-Day 1 vs Cycle 1-Week 12. The mean difference in the TWSTRS severity subscale scores from treatment cycle baseline (Day 1) at the Week 12 visit for Treatment Cycle 1 was determined.||-0.70|-2.81|
72534006|NCT01018680|144597126|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||This is the p-value for the 30% Response (LOCF) based on 24-Hour Average Pain Ratings. A 0.05 level of significance was pre-specified for use in treatment group comparisons.|Fisher Exact|||||||<0.001
72534007|NCT01018680|144597126|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||This is the p-value for the 50% Response (LOCF) based on 24-Hour Average Pain Ratings. A 0.05 level of significance was pre-specified for use in treatment group comparisons.|Fisher Exact|||||||<0.001
72534008|NCT01018680|144597127|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||This is the p-value for the 30% Response (LOCF) based on BPI Average Pain Ratings.|Fisher Exact|||||||<0.001
72534009|NCT01018680|144597127|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||This is the p-value for the 50% Response (LOCF) based on BPI Average Pain Ratings.|Fisher Exact|||||||<0.001
72534010|NCT01018680|144597128|SUPERIORITY_OR_OTHER|||||||0.012||95.0||||A 0.05 level of significance was pre-specified for use in treatment group comparisons.|Fisher Exact|||||||0.012
72534011|NCT01018680|144597129|SUPERIORITY_OR_OTHER|||||||0.724||95.0||||This is the p-value for PCS Weight Gain. A 0.05 level of significance was pre-specified for use in treatment group comparisons.|Fisher Exact|||||||0.724
72534012|NCT01018680|144597129|SUPERIORITY_OR_OTHER|||||||0.106||95.0||||This is the p-value for PCS Weight Loss. A 0.05 level of significance was pre-specified for use in treatment group comparisons.|Fisher Exact|||||||0.106
72534013|NCT01018680|144597130|SUPERIORITY_OR_OTHER|||||||0.031||95.0||||A 0.05 level of significance was pre-specified for use in treatment group comparisons.|Fisher Exact|||||||0.031
72534014|NCT01018680|144597131|SUPERIORITY_OR_OTHER|||||||0.063||95.0||||This is the p-value for Diastolic Hypertension. A 0.05 level of significance was pre-specified for use in treatment group comparisons.|Fisher Exact|||||||0.063
72534015|NCT01018680|144597131|SUPERIORITY_OR_OTHER|||||||0.018||95.0||||This is the p-value for Systolic Hypertension. A 0.05 level of significance was pre-specified for use in treatment group comparisons.|Fisher Exact|||||||0.018
72534016|NCT01018680|144597132|SUPERIORITY_OR_OTHER|||||||0.249||95.0||||A 0.05 level of significance was pre-specified for use in treatment group comparisons.|Fisher Exact|||||||0.249
72534017|NCT01018680|144597133|SUPERIORITY_OR_OTHER|||||||0.241||95.0||||This is the p-value for outpatient group visits. A 0.05 level of significance was pre-specified for use in treatment group comparisons.|Likelihood Ratio Chi-squared|||||||0.241
72534018|NCT01018680|144597133|SUPERIORITY_OR_OTHER|||||||0.087||95.0||||This is the p-value for outpatient individual visits. A 0.05 level of significance was pre-specified for use in treatment group comparisons.|Likelihood Ratio Chi-squared|||||||0.087
72534019|NCT01018680|144597133|SUPERIORITY_OR_OTHER|||||||0.414||95.0||||This is the p-value for emergency room visits for non-psychiatric illness. A 0.05 level of significance was pre-specified for use in treatment group comparisons.|Likelihood Ratio Chi-squared|||||||0.414
72534020|NCT01018680|144597133|SUPERIORITY_OR_OTHER|||||||0.332||95.0||||This is the p-value for outpatient visits to other physicians. A 0.05 level of significance was pre-specified for use in treatment group comparisons.|Likelihood Ratio Chi-squared|||||||0.332
72534021|NCT01018680|144597133|SUPERIORITY_OR_OTHER|||||||0.183||95.0||||This is the p-value for the average number of hours worked for pay per week. A 0.05 level of significance was pre-specified for use in treatment group comparisons.|Likelihood Ratio Chi-squared|||||||0.183
72534022|NCT01018680|144597133|SUPERIORITY_OR_OTHER|||||||0.666||95.0||||This is the p-value for how long the participant has had this job. A 0.05 level of significance was pre-specified for use in treatment group comparisons.|Likelihood Ratio Chi-squared|||||||0.666
72534023|NCT01018680|144597133|SUPERIORITY_OR_OTHER|||||||0.89||95.0||||This is the p-value for the average number of hours of volunteer work per week. A 0.05 level of significance was pre-specified for use in treatment group comparisons.|Likelihood Ratio Chi-squared|||||||0.890
72534024|NCT01018680|144597133|SUPERIORITY_OR_OTHER|||||||0.413||95.0||||This is the p-value for psychiatric visits. A 0.05 level of significance was pre-specified for use in treatment group comparisons.|Likelihood Ratio Chi-squared|||||||0.413
72534025|NCT02777554|144597143|EQUIVALENCE|Equivalent exposure of the QD formulation to the BID tablet was established if the 90% confidence intervals (CIs) of the geometric mean ratio for Day 7 AUC0-24 and Cmax were completely contained within the range of 80% to 125%.|Ratio (%) of Geometric Means|101.6|||||TWO_SIDED|90.0|95.1|108.5|||||Geometric mean ratio (Apremilast 75 mg XL QD / Apremilast 30 mg IR BID) from an ANOVA model, expressed as a percentage.|To assess the exposure between the extended release apremilast formulation, and Reference IR (30 mg reference IR BID) tablet following multiple oral doses, an analysis of variance (ANOVA) model, with sequence, period, and treatment as fixed effects, and subject nested within sequence as a random effect, was performed on the natural log-transformed Day 7 Cmax.||108.5|95.1|
72572507|NCT01753336|144672522|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.0|STANDARD_DEVIATION|3.77|||TWO_SIDED|95.0|-3.75|-2.23||||||Cycle 2-Day 1 vs Cycle 2-Week 4. The mean difference in the TWSTRS severity subscale scores from treatment cycle baseline (Day 1) at the Week 4 visit for Treatment Cycle 2 was determined.||-2.23|-3.75|
72408063|NCT03238911|144324435|SUPERIORITY||Mean Difference (Final Values)|-71.02||||0.0459|TWO_SIDED|95.0|-140.74|-1.3|||Mixed model for repeated measures|||"Day 8~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||-1.30|-140.74|0.0459
72408064|NCT03238911|144324435|SUPERIORITY||Mean Difference (Final Values)|-207.33|||<|0.0001|TWO_SIDED|95.0|-268.82|-145.84|||Mixed model for repeated measures|||"Day 14~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||-145.84|-268.82|<0.0001
72408065|NCT03238911|144324435|SUPERIORITY||Mean Difference (Final Values)|-78.6||||0.001|TWO_SIDED|95.0|-124.81|-32.39|||Mixed model for repeated measures|||"Day 21~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||-32.39|-124.81|0.0010
72408066|NCT03238911|144324435|SUPERIORITY||Mean Difference (Final Values)|-58.79||||0.0002|TWO_SIDED|95.0|-88.75|-28.82|||Mixed model for repeated measures|||"Day 35~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||-28.82|-88.75|0.0002
72408067|NCT03238911|144324436|SUPERIORITY||Mean Difference (Final Values)|40.82|||<|0.0001|TWO_SIDED|95.0|26.3|55.33|||Mixed model for repeated measures|||"Day 1~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||55.33|26.30|<0.0001
72408068|NCT03238911|144324436|SUPERIORITY||Mean Difference (Final Values)|6.61||||0.0089|TWO_SIDED|95.0|1.69|11.53|||Mixed model for repeated measures|||"Day 7~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||11.53|1.69|0.0089
72408069|NCT03238911|144324436|SUPERIORITY||Mean Difference (Final Values)|-43.48|||<|0.0001|TWO_SIDED|95.0|-54.92|-32.03|||Mixed model for repeated measures|||"Day 8~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||-32.03|-54.92|<0.0001
72534026|NCT02777554|144597144|EQUIVALENCE|Equivalent exposure of the QD formulation to the BID tablet was established if the 90% CIs of the geometric mean ratio for Day 7 AUC0-24 and Cmax were completely contained within the range of 80% to 125%.|Ratio (%) of Geometric Means|95.3|||||TWO_SIDED|90.0|88.9|102.2|||||Geometric mean ratio (Apremilast 75 mg XL QD / Apremilast 30 mg IR BID) from an ANOVA model, expressed as a percentage.|To assess the exposure between the extended release apremilast formulation, and Reference IR (30 mg reference IR BID) tablet following multiple oral doses, an ANOVA model, with sequence, period, and treatment as fixed effects, and subject nested within sequence as a random effect, was performed on the natural log-transformed Day 7 AUC0-24.||102.2|88.9|
72534027|NCT02777554|144597145|OTHER||Ratio (%) of Geometric Means|103.9|||||TWO_SIDED|90.0|93.6|115.4|||||Geometric mean ratio (Apremilast 75 mg XL / Apremilast 30 mg IR BID) from an ANOVA model, expressed as a percentage.|To estimate the exposure of apremilast following single dose administration of extended release (QD) relative to the Reference IR (BID) tablet under fasted conditions, an ANOVA model with treatment, sequence, and period as fixed effects, and subject nested within sequence as a random effect, was performed on the natural log-transformed Cmax of apremilast.||115.4|93.6|
72534028|NCT02777554|144597145|OTHER||Ratio (%) of Geometric Means|90.9|||||TWO_SIDED|90.0|81.6|101.3|||||Geometric mean ratio (Apremilast 75 mg XL (Fasted) / Apremilast 75 mg XL (Standard Meal)) from an ANOVA model, expressed as a percentage.|To estimate the effect of food on the PK of a single oral dose of extended release apremilast (QD), an ANOVA model with treatment, sequence, and period as fixed effects, and subject nested within sequence as a random effect, was performed on the natural log-transformed Cmax of apremilast.||101.3|81.6|
72534029|NCT02777554|144597145|OTHER||Ratio (%) of Geometric Means|115.0|||||TWO_SIDED|90.0|103.3|128.1|||||Geometric mean ratio (Apremilast 75 mg XL (High Fat) / Apremilast 75 mg XL (Standard Meal)) from an ANOVA model, expressed as a percentage.|To estimate the effect of food on the PK of a single oral dose of extended release apremilast (QD), an ANOVA model with treatment, sequence, and period as fixed effects, and subject nested within sequence as a random effect, was performed on the natural log-transformed Cmax of apremilast.||128.1|103.3|
72626405|NCT00402987|144781758|SUPERIORITY_OR_OTHER_LEGACY|||||||0.012||95.0||||Analysis for meaningful Relief at 2 hours|Regression, Logistic|Treatment as a factor||||||0.012
72408070|NCT03238911|144324436|SUPERIORITY||Mean Difference (Final Values)|-1.68||||0.373|TWO_SIDED|95.0|-5.41|2.04|||Mixed model for repeated measures|||"Day 14~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||2.04|-5.41|0.3730
72534030|NCT02777554|144597145|OTHER||Ratio (%) of Geometric Means|126.5|||||TWO_SIDED|90.0|113.7|140.8|||||Geometric mean ratio (Apremilast 75 mg XL (High Fat) / Apremilast 75 mg XL (Fasted)) from an ANOVA model, expressed as a percentage.|To estimate the effect of food on the PK of a single oral dose of extended release apremilast (QD), an ANOVA model with treatment, sequence, and period as fixed effects, and subject nested within sequence as a random effect, was performed on the natural log-transformed Cmax of apremilast.||140.8|113.7|
72572508|NCT01753336|144672522|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.5|STANDARD_DEVIATION|3.86|||TWO_SIDED|95.0|-1.33|0.27||||||Cycle 2-Day 1 vs Cycle 2-Week 12. The mean difference in the TWSTRS severity subscale scores from treatment cycle baseline (Day 1) at the Week 12 visit for Treatment Cycle 2 was determined.||0.27|-1.33|
72572509|NCT01753336|144672522|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.7|STANDARD_DEVIATION|4.32|||TWO_SIDED|95.0|-3.64|-1.83||||||Cycle 3-Day 1 vs Cycle 3-Week 4. The mean difference in the TWSTRS severity subscale scores from treatment cycle baseline (Day 1) at the Week 4 visit for Treatment Cycle 3 was determined.||-1.83|-3.64|
72572510|NCT01753336|144672522|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.0|STANDARD_DEVIATION|4.77|||TWO_SIDED|95.0|-2.0|-0.02||||||Cycle 3-Day 1 vs Cycle 3-Week 12. The mean difference in the TWSTRS severity subscale scores from treatment cycle baseline (Day 1) at the Week 12 visit for Treatment Cycle 3 was determined.||-0.02|-2.00|
72572511|NCT01753336|144672523|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.9|STANDARD_DEVIATION|3.86|||TWO_SIDED|95.0|-3.64|-2.12||||||Cycle 1-Day 1 vs Cycle 1-Week 4. The mean difference in the TWSTRS disability subscale scores from treatment cycle baseline (Day 1) at the Week 4 visit for Treatment Cycle 1 was determined.||-2.12|-3.64|
72572512|NCT01753336|144672523|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.8|STANDARD_DEVIATION|4.82|||TWO_SIDED|95.0|-2.79|-0.86||||||Cycle 1-Day 1 vs Cycle 1-Week 12.The mean difference in the TWSTRS disability subscale scores from treatment cycle baseline (Day 1) at the Week 12 visit for Treatment Cycle 1 was determined.||-0.86|-2.79|
72572513|NCT01753336|144672523|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.7|STANDARD_DEVIATION|3.47|||TWO_SIDED|95.0|-2.44|-1.04||||||Cycle 2-Day 1 vs Cycle 2-Week 4. The mean difference in the TWSTRS disability subscale scores from treatment cycle baseline (Day 1) at the Week 4 visit for Treatment Cycle 2 was determined.||-1.04|-2.44|
72572514|NCT01753336|144672523|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.8|STANDARD_DEVIATION|3.46|||TWO_SIDED|95.0|-1.55|-0.12||||||Cycle 2-Day 1 vs Cycle 2-Week 12. The mean difference in the TWSTRS disability subscale scores from treatment cycle baseline (Day 1) at the Week 12 visit for Treatment Cycle 2 was determined.||-0.12|-1.55|
72572515|NCT01753336|144672523|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.7|STANDARD_DEVIATION|3.75|||TWO_SIDED|95.0|-1.45|0.12||||||Cycle 3-Day 1 vs Cycle 3-Week 4. The mean difference in the TWSTRS disability subscale scores from treatment cycle baseline (Day 1) at the Week 4 visit for Treatment Cycle 3 was determined.||0.12|-1.45|
72572516|NCT01753336|144672523|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1|STANDARD_DEVIATION|3.73|||TWO_SIDED|95.0|-0.85|0.7||||||Cycle 3-Day 1 vs Cycle 3-Week 12.The mean difference in the TWSTRS disability subscale scores from treatment cycle baseline (Day 1) at the Week 12 visit for Treatment Cycle 3 was determined.||0.70|-0.85|
72572517|NCT01753336|144672524|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.7|STANDARD_DEVIATION|3.74|||TWO_SIDED|95.0|-2.39|-0.92||||||Cycle 1-Day 1 vs Cycle 1-Week 4. The mean difference in the TWSTRS pain subscale scores from treatment cycle baseline (Day 1) at the Week 4 visit for Treatment Cycle 1 was determined.||-0.92|-2.39|
72408071|NCT03238911|144324436|SUPERIORITY||Mean Difference (Final Values)|-1.63||||0.4778|TWO_SIDED|95.0|-6.15|2.9|||Mixed model for repeated measures|||"Day 21~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||2.90|-6.15|0.4778
72572518|NCT01753336|144672524|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.4|STANDARD_DEVIATION|3.88|||TWO_SIDED|95.0|-2.22|-0.66||||||Cycle 1-Day 1 vs Cycle 1-Week 12. The mean difference in the TWSTRS pain subscale scores from treatment cycle baseline (Day 1) at the Week 12 visit for Treatment Cycle 1 was determined.||-0.66|-2.22|
72572519|NCT01753336|144672524|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.2|STANDARD_DEVIATION|3.12|||TWO_SIDED|95.0|-1.84|-0.58||||||Cycle 2-Day 1 vs Cycle 2-Week 4.The mean difference in the TWSTRS pain subscale scores from treatment cycle baseline (Day 1) at the Week 4 visit for Treatment Cycle 2 was determined.||-0.58|-1.84|
72572520|NCT01753336|144672524|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.5|STANDARD_DEVIATION|3.04|||TWO_SIDED|95.0|-1.08|0.18||||||Cycle 2-Day 1 vs Cycle 2-Week 12. The mean difference in the TWSTRS pain subscale scores from treatment cycle baseline (Day 1) at the Week 12 visit for Treatment Cycle 2 was determined.||0.18|-1.08|
72572521|NCT01753336|144672524|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.7|STANDARD_DEVIATION|4.2|||TWO_SIDED|95.0|-1.57|0.19||||||Cycle 3-Day 1 vs Cycle 3-Week 4. The mean difference in the TWSTRS pain subscale scores from treatment cycle baseline (Day 1) at the Week 4 visit for Treatment Cycle 3 was determined.||0.19|-1.57|
72572522|NCT01753336|144672524|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1|STANDARD_DEVIATION|3.78|||TWO_SIDED|95.0|-0.85|0.73||||||Cycle 3-Day 1 vs Cycle 3-Week 12. The mean difference in the TWSTRS pain subscale scores from treatment cycle baseline (Day 1) at the Week 12 visit for Treatment Cycle 3 was determined.||0.73|-0.85|
72572523|NCT01629966|144672561|SUPERIORITY||Least Squares Mean Difference|-1.27||||0.083|TWO_SIDED|95.0|-2.71|0.17|||MMRM|||||0.17|-2.71|0.0830
72572524|NCT01629966|144672561|SUPERIORITY||Least Squares Mean Difference|-1.8||||0.0156|TWO_SIDED|95.0|-3.26|-0.34|||MMRM|||||-0.34|-3.26|0.0156
72572525|NCT01629966|144672562|SUPERIORITY||Least Squares Mean Difference|-1.37||||0.0536|TWO_SIDED|95.0|-2.75|0.02|||MMRM|||||0.02|-2.75|0.0536
72572526|NCT01629966|144672562|SUPERIORITY||Least Squares Mean Difference|-1.52||||0.0349|TWO_SIDED|95.0|-2.94|-0.11|||MMRM|||||-0.11|-2.94|0.0349
72572527|NCT03801382|144672578|EQUIVALENCE|Validity and test-retest reliability were explored|Mean Difference (Final Values)|0.05|||>|0.05|TWO_SIDED||||||t-test, 2 sided||||Validity and test-retest reliability were explored|||>.05
72626406|NCT00402987|144781758|SUPERIORITY_OR_OTHER_LEGACY|||||||0.453||95.0||||Analysis for meaningful Relief at 2 hours|Regression, Logistic|Treatment as a factor||||||0.453
72626407|NCT00402987|144781758|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||Analysis for meaningful Relief at 6 hours|Regression, Logistic|Treatment as a factor||||||<0.001
72534031|NCT02777554|144597146|OTHER||Ratio (%) of Geometric Means|92.9|||||TWO_SIDED|90.0|81.3|106.2|||||Geometric mean ratio (Apremilast 75 mg XL / Apremilast 30 mg IR BID) from an ANOVA model, expressed as a percentage.|To estimate the exposure of apremilast following single dose administration of extended release (QD) relative to the Reference IR (BID) tablet under fasted conditions, an ANOVA model with treatment, sequence, and period as fixed effects, and subject nested within sequence as a random effect, was performed on the natural log-transformed AUC0-t of apremilast.||106.2|81.3|
72534032|NCT02777554|144597146|OTHER||Ratio (%) of Geometric Means|86.0|||||TWO_SIDED|90.0|74.9|98.7|||||Geometric mean ratio (Apremilast 75 mg XL (Fasted) / Apremilast 75 mg XL (Standard Meal)) from an ANOVA model, expressed as a percentage.|To estimate the effect of food on the PK of a single oral dose of extended release apremilast (QD), an ANOVA model with treatment, sequence, and period as fixed effects, and subject nested within sequence as a random effect, was performed on the natural log-transformed AUC0-t of apremilast.||98.7|74.9|
72534033|NCT02777554|144597146|OTHER||Ratio (%) of Geometric Means|97.3|||||TWO_SIDED|90.0|84.9|111.6|||||Geometric mean ratio (Apremilast 75 mg XL (High Fat) / Apremilast 75 mg XL (Standard Meal)) from an ANOVA model, expressed as a percentage.|To estimate the effect of food on the PK of a single oral dose of extended release apremilast (QD), an ANOVA model with treatment, sequence, and period as fixed effects, and subject nested within sequence as a random effect, was performed on the natural log-transformed AUC0-t of apremilast.||111.6|84.9|
72534034|NCT02777554|144597146|OTHER||Ratio (%) of Geometric Means|113.2|||||TWO_SIDED|90.0|98.8|129.7|||||Geometric mean ratio (Apremilast 75 mg XL (High Fat) / Apremilast 75 mg XL (Fasted)) from an ANOVA model, expressed as a percentage.|To estimate the effect of food on the PK of a single oral dose of extended release apremilast (QD), an ANOVA model with treatment, sequence, and period as fixed effects, and subject nested within sequence as a random effect, was performed on the natural log-transformed AUC0-t of apremilast.||129.7|98.8|
72534035|NCT02777554|144597147|OTHER||Ratio (%) of Geometric Means|92.6|||||TWO_SIDED|90.0|81.1|105.9|||||Geometric mean ratio (Apremilast 75 mg XL / Apremilast 30 mg IR BID) from an ANOVA model, expressed as a percentage.|To estimate the exposure of apremilast following single dose administration of extended release (QD) relative to the Reference IR (BID) tablet under fasted conditions, an ANOVA model with treatment, sequence, and period as fixed effects, and subject nested within sequence as a random effect, was performed on the natural log-transformed AUC0-∞ of apremilast.||105.9|81.1|
72534036|NCT02777554|144597147|OTHER||Ratio (%) of Geometric Means|86.1|||||TWO_SIDED|90.0|75.0|98.8|||||Geometric mean ratio (Apremilast 75 mg XL (Fasted) / Apremilast 75 mg XL (Standard Meal)) from an ANOVA model, expressed as a percentage.|To estimate the effect of food on the PK of a single oral dose of extended release apremilast (QD), an ANOVA model with treatment, sequence, and period as fixed effects, and subject nested within sequence as a random effect, was performed on the natural log-transformed AUC0-∞ of apremilast.||98.8|75.0|
72534037|NCT02777554|144597147|OTHER||Ratio (%) of Geometric Means|97.5|||||TWO_SIDED|90.0|85.0|111.8|||||Geometric mean ratio (Apremilast 75 mg XL (High Fat) / Apremilast 75 mg XL (Standard Meal)) from an ANOVA model, expressed as a percentage.|To estimate the effect of food on the PK of a single oral dose of extended release apremilast (QD), an ANOVA model with treatment, sequence, and period as fixed effects, and subject nested within sequence as a random effect, was performed on the natural log-transformed AUC0-∞ of apremilast.||111.8|85.0|
72534038|NCT02777554|144597147|OTHER||Ratio (%) of Geometric Means|113.2|||||TWO_SIDED|90.0|98.8|129.7|||||Geometric mean ratio (Apremilast 75 mg XL (High Fat) / Apremilast 75 mg XL (Fasted)) from an ANOVA model, expressed as a percentage.|To estimate the effect of food on the PK of a single oral dose of extended release apremilast (QD), an ANOVA model with treatment, sequence, and period as fixed effects, and subject nested within sequence as a random effect, was performed on the natural log-transformed AUC0-∞ of apremilast.||129.7|98.8|
72534039|NCT00066573|144597177|SUPERIORITY|To detect a hazard ratio (HR) of 0.80 between exemestane and anastrozole (ie, an improvement in 5-year EFS from 87.5% to 89.9%, with a two-sided 5% level test and 80% power, 6,840 patients and 630 events were needed for final analysis.|Hazard Ratio (HR)|1.02||||0.85|TWO_SIDED|95.0|0.87|1.18|||Log Rank|||||1.18|0.87|0.85
72534040|NCT00066573|144597178|SUPERIORITY|No power calculation for secondary analysis|Hazard Ratio (HR)|0.93||||0.46|TWO_SIDED|95.0|0.77|1.13|||Log Rank|||||1.13|0.77|0.46
72534041|NCT02646566|144597202|SUPERIORITY|||||||0.003||||||One-sided p-value. After adjustment for multiplicity using Hommel's method. (Note: unadjusted p value = 0.003) A priori threshold for statistical significance = 0.025.|Chi-squared|||The primary efficacy analysis was a comparison of the incidence of the primary efficacy variable between the two groups that received APD421 and the group that received placebo, using Pearson's χ2 test. The threshold for determining statistical significance in the comparison of incidence of success between the active and placebo groups (the primary efficacy analysis) was a p-value of 2.5% one-sided.||||0.003
72534042|NCT02646566|144597202|SUPERIORITY|||||||0.109||||||One-sided p-value. After adjustment for multiplicity using Hommel's method. (Note: unadjusted p value = 0.109) A priori threshold for statistical significance = 0.025.|Chi-squared|||The primary efficacy analysis was a comparison of the incidence of the primary efficacy variable between the two groups that received APD421 and the group that received placebo, using Pearson's χ2 test. The threshold for determining statistical significance in the comparison of incidence of success between the active and placebo groups (the primary efficacy analysis) was a p-value of 2.5% one-sided.||||0.109
72534043|NCT02646566|144597203|SUPERIORITY||||||<|0.001||||||One-sided p-value. No adjustment for multiple comparisons. A priori threshold for statistical significance = 0.025.|Chi-squared|||||||<0.001
72534044|NCT02646566|144597203|SUPERIORITY|||||||0.059||||||One-sided p-value. No adjustment for multiple comparisons. A priori threshold for statistical significance = 0.025.|Chi-squared|||||||0.059
72534045|NCT02646566|144597204|SUPERIORITY||||||<|0.001||||||One-sided p-value. No adjustment for multiple comparisons. A priori threshold for statistical significance = 0.025.|Chi-squared|||||||<0.001
72534046|NCT02646566|144597204|SUPERIORITY|||||||0.053||||||One-sided p-value. No adjustment for multiple comparisons. A priori threshold for statistical significance = 0.025.|Chi-squared|||||||0.053
72626408|NCT00402987|144781758|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001||95.0||||Analysis for meaningful Relief at 6 hours|Regression, Logistic|Treatment as a factor||||||0.001
72534047|NCT02646566|144597205|SUPERIORITY||||||<|0.001||||||One-sided p-value. No adjustment for multiple comparisons. A priori threshold for statistical significance = 0.025.|Chi-squared|||||||<0.001
72408072|NCT03238911|144324436|SUPERIORITY||Mean Difference (Final Values)|-1.73||||0.3575|TWO_SIDED|95.0|-5.44|1.98|||Mixed model for repeated measures|||"Day 35~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||1.98|-5.44|0.3575
72534048|NCT02646566|144597205|SUPERIORITY|||||||0.021||||||One-sided p-value. No adjustment for multiple comparisons. A priori threshold for statistical significance = 0.025.|Chi-squared|||||||0.021
72572528|NCT04188301|144672587|SUPERIORITY||Odds Ratio (OR)|1.41||||0.192|TWO_SIDED|95.0|0.84|2.38||Participant level random effects were included in the model to adjust for multiple worms/person. Adjusted P values were model-adjusted for repeated measurements per person.|Regression, Logistic|Mixed-effects logistic regression model where study participant was included as a random effect to adjust for multiple worms per person.||IA vs IDA for living female O. volvulus worms in nodules after treatment.||2.38|0.84|0.192
72572529|NCT04188301|144672587|SUPERIORITY||Odds Ratio (OR)|1.45||||0.107|TWO_SIDED|95.0|0.92|2.29||Participant level random effects were included in the model to adjust for multiple worms/person. Adjusted P values were model-adjusted for repeated measurements per person.|Regression, Logistic|Mixed-effects logistic regression model where study participant was included as a random effect to adjust for multiple worms per person.||IA vs IDA3 for living female O. volvulus worms in nodules after treatment.||2.29|0.92|0.107
72572530|NCT04188301|144672587|SUPERIORITY|IA vs IDA treatment groups for living female O. volvulus worms in nodules after treatment.|Odds Ratio (OR)|1.44||||0.068|TWO_SIDED|95.0|0.97|2.15||Participant level random effects were included in the model to adjust for multiple worms/person. Adjusted P values were model-adjusted for repeated measurements per person.|Regression, Logistic|Mixed-effects logistic regression model where study participant was included as a random effect to adjust for multiple worms per person.||||2.15|0.97|0.068
72572531|NCT04188301|144672587|SUPERIORITY||Odds Ratio (OR)|1.03||||0.918|TWO_SIDED|95.0|0.59|1.79||Participant level random effects were included in the model to adjust for multiple worms/person. Adjusted P values were model-adjusted for repeated measurements per person.|Regression, Logistic|Mixed-effects logistic regression model where study participant was included as a random effect to adjust for multiple worms per person.||IDA vs IDA3 for living female O. volvulus worms in nodules after treatment.||1.79|0.59|0.918
72572532|NCT04188301|144672590|SUPERIORITY||Odds Ratio (OR)|1.41||||0.192|TWO_SIDED|95.0|0.84|2.38||Participant level random effects were included in the model to adjust for multiple worms/person. Adjusted P values were model-adjusted for repeated measurements per person.|Regression, Logistic|Mixed-effects logistic regression model where study participant was included as a random effect to adjust for multiple worms per person.||IA vs IDA for living female O. volvulus worms in nodules after treatment.||2.38|0.84|0.192
72572533|NCT04188301|144672590|SUPERIORITY||Odds Ratio (OR)|1.45||||0.107|TWO_SIDED|95.0|0.92|2.29||Participant level random effects were included in the model to adjust for multiple worms/person. Adjusted P values were model-adjusted for repeated measurements per person.|Regression, Logistic|Mixed-effects logistic regression model where study participant was included as a random effect to adjust for multiple worms per person.||IA vs IDA3 for living female O. volvulus worms in nodules after treatment.||2.29|0.92|0.107
72572534|NCT04188301|144672590|SUPERIORITY||Odds Ratio (OR)|1.44||||0.068|TWO_SIDED|95.0|0.97|2.15||Participant level random effects were included in the model to adjust for multiple worms/person. Adjusted P values were model-adjusted for repeated measurements per person.|Regression, Logistic|Mixed-effects logistic regression model where study participant was included as a random effect to adjust for multiple worms per person.||IA vs IDA groups for living female O. volvulus worms in nodules after treatment.||2.15|0.97|0.068
72572535|NCT04188301|144672590|SUPERIORITY||Odds Ratio (OR)|1.03||||0.918|TWO_SIDED|95.0|0.59|1.79||Participant level random effects were included in the model to adjust for multiple worms/person. Adjusted P values were model-adjusted for repeated measurements per person.|Regression, Logistic|Mixed-effects logistic regression model where study participant was included as a random effect to adjust for multiple worms per person.||IDA vs IDA3 for living female O. volvulus worms in nodules after treatment.||1.79|0.59|0.918
72572536|NCT04188301|144672593|SUPERIORITY||Odds Ratio (OR)|1.66||||0.134|TWO_SIDED|95.0|0.85|3.21||Adjusted p values were model-adjusted for repeated measurements per person. Participant level random effects were included in the model to adjust for multiple worms/person.|Regression, Logistic|Mixed-effects logistic regression model where study participant was included as a random effect to adjust for multiple worms per person.||IA vs IDA in fertile female O. volvulus worms in nodules after treatment.||3.21|0.85|0.134
72626409|NCT00402987|144781758|SUPERIORITY_OR_OTHER_LEGACY|||||||0.814||95.0||||Analysis for meaningful Relief at 6 hours|Regression, Logistic|Treatment as a factor||||||0.814
72534049|NCT02646566|144597206|SUPERIORITY||||||<|0.001|||||||Regression, Cox|||||||<0.001
72534050|NCT02646566|144597206|SUPERIORITY|||||||0.084|||||||Regression, Cox|||||||0.084
72626410|NCT00402987|144781758|SUPERIORITY_OR_OTHER_LEGACY|||||||0.024||95.0||||Analysis for Much Improvement at 2 hours|Regression, Logistic|Treatment as a factor||||||0.024
72626411|NCT00402987|144781758|SUPERIORITY_OR_OTHER_LEGACY|||||||0.022||95.0||||Analysis for Much Improvement at 2 hours|Regression, Logistic|Treatment as a factor||||||0.022
72626412|NCT00402987|144781758|SUPERIORITY_OR_OTHER_LEGACY|||||||0.966||95.0||||Analysis for Much Improvement at 2 hours|Regression, Logistic|Treatment as a factor||||||0.966
72534051|NCT02646566|144597207|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
72534052|NCT02646566|144597207|SUPERIORITY|||||||0.004|||||||Chi-squared|||||||0.004
72534053|NCT02646566|144597208|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
72534054|NCT02646566|144597208|SUPERIORITY|||||||0.179|||||||Chi-squared|||||||0.179
72534055|NCT02646566|144597209|SUPERIORITY|||||||0.009|||||||Chi-squared|||||||0.009
72534056|NCT02646566|144597209|SUPERIORITY|||||||0.315|||||||Chi-squared|||||||0.315
72534057|NCT02646566|144597210|SUPERIORITY|||||||0.065|||||||Chi-squared|||||||0.065
72534058|NCT02646566|144597210|SUPERIORITY|||||||0.52|||||||Chi-squared|||||||0.520
72534059|NCT02646566|144597211|SUPERIORITY|||||||0.008|||||||Wilcoxon (Mann-Whitney)|||||||0.008
72626413|NCT00402987|144781758|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001||95.0||||Analysis for Much Improvement at 6 hours|Regression, Logistic|Treatment as a factor||||||0.001
72626414|NCT00402987|144781758|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001||95.0||||Analysis for Much Improvement at 6 hours|Regression, Logistic|Treatment as a factor||||||0.001
72626415|NCT00402987|144781758|SUPERIORITY_OR_OTHER_LEGACY|||||||0.798||95.0||||Analysis for Much Improvement at 6 hours|Regression, Logistic|Treatment as a factor||||||0.798
72626416|NCT00402987|144781759|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||Analysis for Meaningful Relief|Regression, Logistic|Treatment as a factor||||||<0.001
72534060|NCT02646566|144597211|SUPERIORITY|||||||0.42|||||||Wilcoxon (Mann-Whitney)|||||||0.420
72626417|NCT00402987|144781759|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||Analysis for Meaningful Relief|Regression, Logistic|Treatment as a factor||||||<0.001
72534061|NCT02646566|144597212|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
72534062|NCT02646566|144597212|SUPERIORITY|||||||0.258|||||||Wilcoxon (Mann-Whitney)|||||||0.258
72534063|NCT02222246|144597213|NON_INFERIORITY|Change in pain scores from arrival to discharge||||||0.0311|||||||Mixed Models Analysis|Analysis for pain change was conducted using Hierarchical Linear Mixed Effects Model (HLM), adjusting for nested patient and site effects (N=126)||||||0.0311
72534064|NCT02222246|144597214|NON_INFERIORITY|Trajectory of pain across time (arrival to discharge)||||||0.0049||||||p-value for the protocol by time interaction|Mixed Models Analysis|||The trajectory of change in pain score was evaluated every 30 minutes over 120 hours (2 hours) rather than 6 hours because of expected missing data after 120 minutes due to discharge from the ED.||||0.0049
72626418|NCT00402987|144781759|SUPERIORITY_OR_OTHER_LEGACY|||||||0.008||95.0||||Analysis for Meaningful Relief|Regression, Logistic|Treatment as a factor||||||0.008
72534065|NCT02222246|144597214|NON_INFERIORITY|Emergency Department Arrival||||||0.9393|||||||t-test, 2 sided|||||||0.9393
72534066|NCT02222246|144597214|NON_INFERIORITY|Post-placement 30 minutes||||||0.7259|||||||t-test, 2 sided|||||||0.7259
72534067|NCT02222246|144597214|NON_INFERIORITY|Post-placement 60 minutes||||||0.53|||||||t-test, 2 sided|||||||0.5300
72534068|NCT02222246|144597214|NON_INFERIORITY|Post-placement 90 minutes||||||0.3678|||||||t-test, 2 sided|||||||0.3678
72534069|NCT02222246|144597214|NON_INFERIORITY|Post-placement 120 minutes||||||0.2457|||||||t-test, 2 sided|||||||0.2457
72534070|NCT02222246|144597214|NON_INFERIORITY|Emergency Department Discharge||||||0.0007|||||||t-test, 2 sided|||||||0.0007
72534071|NCT02222246|144597215|NON_INFERIORITY|Incidence of nausea during Emergency Department Visit - YES||||||0.0001|||||||Chi-squared|||||||0.0001
72534072|NCT02222246|144597216|NON_INFERIORITY|Incidence of vomiting (YES) during Emergency Department visit||||||0.6625|||||||Chi-squared|||||||0.6625
72534073|NCT02222246|144597217|NON_INFERIORITY|Decrease in systolic BP (\>= 20% of baseline)||||||0.4473|||||||Chi-squared|||||||0.4473
72534074|NCT02222246|144597218|NON_INFERIORITY|Decrease in diastolic blood pressure (\>= 20% baseline)||||||0.5372|||||||Chi-squared|||||||0.5372
72534075|NCT02222246|144597219|NON_INFERIORITY|Incidence of oxygen desaturation (\<95%) YES during Emergency Department visit||||||0.2891|||||||Chi-squared|||||||0.2891
72534076|NCT02222246|144597221|NON_INFERIORITY|Incidence of sedation during Emergency Department visit.||||||0.3915|||||||Chi-squared|||||||0.3915
72534077|NCT02222246|144597222|NON_INFERIORITY|Incidence of the need for supplemental oxygen during Emergency Department visit||||||0.0726|||||||Chi-squared|||||||0.0726
72534078|NCT02660489|144597225|SUPERIORITY|||||||0.78|||||||Wilcoxon (Mann-Whitney)|||||||0.78
72534079|NCT02660489|144597226|SUPERIORITY|||||||0.49|||||||t-test, 2 sided|||||||0.49
72534080|NCT02660489|144597227|SUPERIORITY|||||||0.5|||||||t-test, 2 sided|||||||0.50
72534081|NCT02660489|144597228|SUPERIORITY|||||||0.36|||||||t-test, 2 sided|||||||0.36
72534082|NCT02660489|144597229|SUPERIORITY|||||||0.12|||||||Wilcoxon (Mann-Whitney)|||||||0.12
72534083|NCT02660489|144597230|SUPERIORITY|||||||0.12|||||||Wilcoxon (Mann-Whitney)|||||||0.12
72534084|NCT02660489|144597231|SUPERIORITY|||||||0.75|||||||Wilcoxon (Mann-Whitney)|||||||0.75
72534085|NCT02660489|144597232|SUPERIORITY|||||||0.66|||||||Wilcoxon (Mann-Whitney)|||||||0.66
72534086|NCT00401726|144597261|SUPERIORITY_OR_OTHER||Risk Difference (RD)|5.25||||0.218|||||||Chi-squared|||||||0.218
72534087|NCT00401726|144597262|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.16||||0.76||95.0|-0.92|1.25|||ANCOVA|||||1.25|-0.92|0.76
72534088|NCT00401726|144597263|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.17||||0.148||95.0|-0.41|0.06|||ANCOVA|||||0.06|-0.41|0.148
72534089|NCT00401726|144597264|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.11||||0.829||95.0|-1.09|0.87|||ANCOVA|||||0.87|-1.09|0.829
72534090|NCT00401726|144597265|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.57||||0.728|||||||Chi-squared|||||||0.728
72534091|NCT00401726|144597266|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.25||||0.805||95.0|-2.24|1.74|||ANCOVA|||||1.74|-2.24|0.805
72534092|NCT00401726|144597267|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.0||||0.123||95.0|-2.27|0.27|||ANCOVA|||||0.27|-2.27|0.123
72534093|NCT00401726|144597268|SUPERIORITY_OR_OTHER|||||||0.961|||||||Cochran-Mantel-Haenszel|p-value based on comparison of mean score differences||CGI-I raw scores (range 1-7) analyzed by generalized Cochran-Mantel-Haenszel (CMH) test, stratified by study center using the ridit scoring option.||||0.961
72534094|NCT00830310|144597317|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Sign test|||The null hypothesis is that the median difference between 3 months and baseline equals zero.||||<0.001
72534095|NCT00830310|144597318|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||Sign test|||The null hypothesis is that the median difference between 3 months and baseline equals zero.||||0.002
72534096|NCT00830310|144597319|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||t-test, 2 sided|||The null hypothesis is that the mean difference between 3 months and baseline equals zero.||||0.001
72534097|NCT00830310|144597320|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||t-test, 2 sided|||The null hypothesis is that the mean difference between 3 months and baseline equals zero.||||0.001
72534098|NCT00830310|144597321|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||Sign test|||The null hypothesis is that the median difference between 3 months and baseline equals zero.||||0.001
72534099|NCT00830310|144597322|SUPERIORITY_OR_OTHER|||||||0.011||95.0|||||t-test, 2 sided|||The null hypothesis is that the mean difference between 3 months and baseline equals zero.||||0.011
72534100|NCT00830310|144597323|SUPERIORITY_OR_OTHER|||||||0.038||95.0|||||t-test, 2 sided|||The null hypothesis is that the mean difference between 3 months and baseline equals zero.||||0.038
72572537|NCT04188301|144672593|SUPERIORITY||Odds Ratio (OR)|2.23||||0.023|TWO_SIDED|95.0|1.12|4.44||Participant level random effects were included in the model to adjust for multiple worms/person. Adjusted P values were model-adjusted for repeated measurements per person.|Regression, Logistic|Mixed-effects logistic regression model where study participant was included as a random effect to adjust for multiple worms per person.||IA vs IDA3 for fertile female O. volvulus worms in nodules after treatment.||4.44|1.12|0.023
72534101|NCT00830310|144597324|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||Sign test|||The null hypothesis is that the median difference between 3 months and baseline equals zero.||||0.002
72534102|NCT00830310|144597325|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||The null hypothesis is that the mean difference between 3 months and baseline equals zero.||||<0.001
72534103|NCT01050998|144597326|SUPERIORITY_OR_OTHER||Percent difference|4.9||||0.578|TWO_SIDED|95.0|-11.5|22.0|||Fisher Exact||95 percent (%) unconditional exact confidence interval calculated using the method of Agresti and Min, 2001.|p-value was calculated using a two-tailed Fisher's exact test.||22.0|-11.5|0.578
72534104|NCT01050998|144597326|SUPERIORITY_OR_OTHER||Percent difference|30.7|||<|0.001|TWO_SIDED|95.0|13.4|46.3|||Fisher Exact||95% unconditional exact confidence interval calculated using the method of Agresti and Min, 2001.|p-value was calculated using a two-tailed Fisher's exact test.||46.3|13.4|<0.001
72572538|NCT04188301|144672593|SUPERIORITY||Odds Ratio (OR)|1.32||||0.43|TWO_SIDED|95.0|0.64|2.85||Participant level random effects were included in the model to adjust for multiple worms/person. Adjusted P values were model-adjusted for repeated measurements per person.|Regression, Logistic|Mixed-effects logistic regression model where study participant was included as a random effect to adjust for multiple worms per person.||IDA1 vs IDA3 for fertile female O. volvulus worms in nodules after treatment.||2.85|.64|0.430
72369214|NCT00611026|144248556|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.1||0.0161|TWO_SIDED|95.0|-0.5|-0.1|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.|"Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type:~standard error of the mean."|Treatment difference fesoterodine vs placebo at Week 1.||-0.1|-0.5|0.0161
72534105|NCT01050998|144597326|SUPERIORITY_OR_OTHER||Percent difference|15.3||||0.099|TWO_SIDED|95.0|-1.6|32.2|||Fisher Exact||95% unconditional exact confidence interval calculated using the method of Agresti and Min, 2001.|p-value was calculated using a two-tailed Fisher's exact test.||32.2|-1.6|0.099
72534106|NCT01050998|144597326|SUPERIORITY_OR_OTHER||Percent difference|35.5|||<|0.001|TWO_SIDED|95.0|17.8|50.6|||Fisher Exact||95% unconditional exact confidence interval calculated using the method of Agresti and Min, 2001.|p-value was calculated using a two-tailed Fisher's exact test.||50.6|17.8|<0.001
72534107|NCT01050998|144597327|SUPERIORITY_OR_OTHER||Percent difference|6.4||||0.543|TWO_SIDED|95.0|-11.9|25.4|||Fisher Exact||95% unconditional exact confidence interval calculated using the method of Agresti and Min, 2001.|European region: p-value was calculated using a two-tailed Fisher's exact test.||25.4|-11.9|0.543
72534108|NCT01050998|144597327|SUPERIORITY_OR_OTHER||Percent difference|26.3||||0.011|TWO_SIDED|95.0|7.2|43.6|||Fisher Exact||95% unconditional exact confidence interval calculated using the method of Agresti and Min, 2001.|European region: p-value was calculated using a two-tailed Fisher's exact test.||43.6|7.2|0.011
72534109|NCT01050998|144597327|SUPERIORITY_OR_OTHER||Percent difference|16.6||||0.108|TWO_SIDED|95.0|-2.5|35.5|||Fisher Exact||95% unconditional exact confidence interval calculated using the method of Agresti and Min, 2001.|European region: p-value was calculated using a two-tailed Fisher's exact test.||35.5|-2.5|0.108
72534110|NCT01050998|144597327|SUPERIORITY_OR_OTHER||Percent difference|32.0||||0.001|TWO_SIDED|95.0|12.5|49.0|||Fisher Exact||95% unconditional exact confidence interval calculated using the method of Agresti and Min, 2001.|European region: p-value was calculated using a two-tailed Fisher's exact test.||49.0|12.5|0.001
72534111|NCT01050998|144597327|SUPERIORITY_OR_OTHER||Percent difference|-1.3||||1|TWO_SIDED|95.0|-33.7|35.7|||Fisher Exact||95% unconditional exact confidence interval calculated using the method of Agresti and Min, 2001.|Japanese region: p-value was calculated using a two-tailed Fisher's exact test.||35.7|-33.7|1.000
72534112|NCT01050998|144597327|SUPERIORITY_OR_OTHER||Percent difference|51.5||||0.028|TWO_SIDED|95.0|8.2|77.0|||Fisher Exact||95% unconditional exact confidence interval calculated using the method of Agresti and Min, 2001.|Japanese region: p-value was calculated using a two-tailed Fisher's exact test.||77.0|8.2|0.028
72626419|NCT00402987|144781759|SUPERIORITY_OR_OTHER_LEGACY|||||||0.709||95.0||||Analysis for Meaningful Relief|Regression, Logistic|Treatment as a factor||||||0.709
72626420|NCT00402987|144781759|SUPERIORITY_OR_OTHER_LEGACY|||||||0.331||95.0||||Analysis for Meaningful Relief|Regression, Logistic|Treatment as a factor||||||0.331
72626421|NCT00402987|144781759|SUPERIORITY_OR_OTHER_LEGACY|||||||0.246||95.0||||Analysis for Meaningful Relief|Regression, Logistic|Treatment as a factor||||||0.246
72626422|NCT00402987|144781759|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001||95.0||||Analysis for Much Improvement|Regression, Logistic|Treatment as a factor||||||0.001
72626423|NCT00402987|144781759|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||Analysis for Much Improvement|Regression, Logistic|Treatment as a factor||||||<0.001
72369215|NCT00611026|144248556|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.1||0.0944|TWO_SIDED|95.0|-0.4|0.0|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.|"Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type:~standard error of the mean."|Treatment difference Tolterodine ER vs placebo at Week 1.||0.0|-0.4|0.0944
72534113|NCT01050998|144597327|SUPERIORITY_OR_OTHER||Percent difference|9.8||||0.661|TWO_SIDED|95.0|-24.3|46.9|||Fisher Exact||95% unconditional exact confidence interval calculated using the method of Agresti and Min, 2001.|Japanese region: p-value was calculated using a two-tailed Fisher's exact test.||46.9|-24.3|0.661
72534114|NCT01050998|144597328|SUPERIORITY_OR_OTHER||Percent difference|13.0||||0.152|TWO_SIDED|95.0|-4.2|30.3|||Fisher Exact||95% unconditional exact confidence interval calculated using the method of Agresti and Min, 2001.|p-value was calculated using a two-tailed Fisher's exact test.||30.3|-4.2|0.152
72534115|NCT01050998|144597328|SUPERIORITY_OR_OTHER||Percent difference|24.3||||0.008|TWO_SIDED|95.0|7.0|40.3|||Fisher Exact||95% unconditional exact confidence interval calculated using the method of Agresti and Min, 2001.|p-value was calculated using a two-tailed Fisher's exact test.||40.3|7.0|0.008
72534116|NCT01050998|144597328|SUPERIORITY_OR_OTHER||Percent difference|21.4||||0.02|TWO_SIDED|95.0|3.9|37.8|||Fisher Exact||95% unconditional exact confidence interval calculated using the method of Agresti and Min, 2001.|p-value was calculated using a two-tailed Fisher's exact test.||37.8|3.9|0.020
72534117|NCT01050998|144597328|SUPERIORITY_OR_OTHER||Percent difference|29.0||||0.002|TWO_SIDED|95.0|11.3|45.0|||Fisher Exact||95% unconditional exact confidence interval calculated using the method of Agresti and Min, 2001.|p-value was calculated using a two-tailed Fisher's exact test.||45.0|11.3|0.002
72534118|NCT01050998|144597329|SUPERIORITY_OR_OTHER||Percent difference|9.9||||0.328|TWO_SIDED|95.0|-9.3|29.4|||Fisher Exact||95% unconditional exact confidence interval calculated using the method of Agresti and Min, 2001.|European region: p-value was calculated using a two-tailed Fisher's exact test.||29.4|-9.3|0.328
72534119|NCT01050998|144597329|SUPERIORITY_OR_OTHER||Percent difference|17.2||||0.084|TWO_SIDED|95.0|-2.0|35.6|||Fisher Exact||95% unconditional exact confidence interval calculated using the method of Agresti and Min, 2001.|European region: p-value was calculated using a two-tailed Fisher's exact test.||35.6|-2.0|0.084
72534120|NCT01050998|144597329|SUPERIORITY_OR_OTHER||Percent difference|20.2||||0.049|TWO_SIDED|95.0|0.7|38.2|||Fisher Exact||95% unconditional exact confidence interval calculated using the method of Agresti and Min, 2001.|European region: p-value was calculated using a two-tailed Fisher's exact test.||38.2|0.7|0.049
72534121|NCT01050998|144597329|SUPERIORITY_OR_OTHER||Percent difference|22.8||||0.03|TWO_SIDED|95.0|3.2|40.7|||Fisher Exact||95% unconditional exact confidence interval calculated using the method of Agresti and Min, 2001.|European region: p-value was calculated using a two-tailed Fisher's exact test.||40.7|3.2|0.030
72534122|NCT01050998|144597329|SUPERIORITY_OR_OTHER||Percent difference|26.8||||0.188|TWO_SIDED|95.0|-9.3|60.7|||Fisher Exact||95% unconditional exact confidence interval calculated using the method of Agresti and Min, 2001.|Japanese region: p-value was calculated using a two-tailed Fisher's exact test.||60.7|-9.3|0.188
72534123|NCT01050998|144597329|SUPERIORITY_OR_OTHER||Percent difference|57.4||||0.01|TWO_SIDED|95.0|15.2|81.8|||Fisher Exact||95% unconditional exact confidence interval calculated using the method of Agresti and Min, 2001.|Japanese region: p-value was calculated using a two-tailed Fisher's exact test.||81.8|15.2|0.010
72534124|NCT01050998|144597350|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.31|STANDARD_ERROR_OF_MEAN|0.205||0.137|TWO_SIDED|95.0|-0.71|0.1|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including a treatment by visit interaction term. Differences \<0 favored mavrilimumab.|Analysis reported for change from baseline in DAS28 (CRP) at Day 85.||0.10|-0.71|0.137
72534125|NCT01050998|144597350|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.67|STANDARD_ERROR_OF_MEAN|0.202||0.001|TWO_SIDED|95.0|-1.07|-0.27|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including a treatment by visit interaction term. Differences \<0 favored mavrilimumab.|Analysis reported for change from baseline in DAS28 (CRP) at Day 85.||-0.27|-1.07|0.001
72534126|NCT01050998|144597350|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.35|STANDARD_ERROR_OF_MEAN|0.201||0.08|TWO_SIDED|95.0|-0.75|0.04|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including a treatment by visit interaction term. Differences \<0 favored mavrilimumab.|Analysis reported for change from baseline in DAS28 (CRP) at Day 85.||0.04|-0.75|0.080
72534127|NCT01050998|144597350|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.74|STANDARD_ERROR_OF_MEAN|0.204|<|0.001|TWO_SIDED|95.0|-1.14|-0.33|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including a treatment by visit interaction term. Differences \<0 favored mavrilimumab.|Analysis reported for change from baseline in DAS28 (CRP) at Day 85.||-0.33|-1.14|<0.001
72534128|NCT01050998|144597350|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.34|STANDARD_ERROR_OF_MEAN|0.212||0.107|TWO_SIDED|95.0|-0.76|0.08|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including a treatment by visit interaction term. Differences \<0 favored mavrilimumab.|Analysis reported for change from baseline in DAS28 (ESR) at Day 85.||0.08|-0.76|0.107
72534129|NCT01050998|144597350|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.76|STANDARD_ERROR_OF_MEAN|0.21|<|0.001|TWO_SIDED|95.0|-1.17|-0.35|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including a treatment by visit interaction term. Differences \<0 favored mavrilimumab.|Analysis reported for change from baseline in DAS28 (ESR) at Day 85.||-0.35|-1.17|<0.001
72534130|NCT01050998|144597350|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.42|STANDARD_ERROR_OF_MEAN|0.209||0.046|TWO_SIDED|95.0|-0.83|-0.01|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including a treatment by visit interaction term. Differences \<0 favored mavrilimumab.|Analysis reported for change from baseline in DAS28 (ESR) at Day 85.||-0.01|-0.83|0.046
72534131|NCT01050998|144597350|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.8|STANDARD_ERROR_OF_MEAN|0.212|<|0.001|TWO_SIDED|95.0|-1.22|-0.38|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including a treatment by visit interaction term. Differences \<0 favored mavrilimumab.|Analysis reported for change from baseline in DAS28 (ESR) at Day 85.||-0.38|-1.22|<0.001
72572539|NCT04188301|144672593|SUPERIORITY||Odds Ratio (OR)|1.91||||0.023|TWO_SIDED|95.0|1.09|3.34||Participant level random effects were included in the model to adjust for multiple worms/person. Adjusted P values were model-adjusted for repeated measurements per person.|Regression, Logistic|Mixed-effects logistic regression model where study participant was included as a random effect to adjust for multiple worms per person.||IA vs IDA treatment groups for fertile female O. volvulus worms in nodules after treatment.||3.34|1.09|0.023
72572540|NCT00006721|144672605|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.79||||0.11|TWO_SIDED|95.0|0.6|1.05|||Regression, Cox|adjusting for the stratification factor (serum beta-2 microglobulin level)|CHOP + Tositumomab versus CHOP + Rituximab|||1.05|0.6|0.11
72572541|NCT00006721|144672609|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.55||||0.08|TWO_SIDED|95.0|0.95|2.54|||Regression, Cox|adjusting for the stratification factor (serum beta-2 microglobulin level)|CHOP + Tositumomab versus CHOP + Rituximab|||2.54|0.95|0.08
72534132|NCT01050998|144597351|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.23||0.086|TWO_SIDED|95.0|-0.85|0.06|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including a treatment by visit interaction term. Differences \<0 favored mavrilimumab.|European region: Analysis reported for change from baseline in DAS28 (CRP) at Day 85.||0.06|-0.85|0.086
72534133|NCT01050998|144597351|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.55|STANDARD_ERROR_OF_MEAN|0.225||0.016|TWO_SIDED|95.0|-0.99|-0.1|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including a treatment by visit interaction term. Differences \<0 favored mavrilimumab.|European region: Analysis reported for change from baseline in DAS28 (CRP) at Day 85.||-0.10|-0.99|0.016
72534134|NCT01050998|144597351|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.43|STANDARD_ERROR_OF_MEAN|0.225||0.059|TWO_SIDED|95.0|-0.87|0.02|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including a treatment by visit interaction term. Differences \<0 favored mavrilimumab.|European region: Analysis reported for change from baseline in DAS28 (CRP) at Day 85.||0.02|-0.87|0.059
72534135|NCT01050998|144597351|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.7|STANDARD_ERROR_OF_MEAN|0.227||0.002|TWO_SIDED|95.0|-1.14|-0.25|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including a treatment by visit interaction term. Differences \<0 favored mavrilimumab.|European region: Analysis reported for change from baseline in DAS28 (CRP) at Day 85.||-0.25|-1.14|0.002
72534136|NCT01050998|144597351|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.39|STANDARD_ERROR_OF_MEAN|0.241||0.107|TWO_SIDED|95.0|-0.87|0.09|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including a treatment by visit interaction term. Differences \<0 favored mavrilimumab.|European region: Analysis reported for change from baseline in DAS28 (ESR) at Day 85.||0.09|-0.87|0.107
72534137|NCT01050998|144597351|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.64|STANDARD_ERROR_OF_MEAN|0.236||0.007|TWO_SIDED|95.0|-1.11|-0.18|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including a treatment by visit interaction term. Differences \<0 favored mavrilimumab.|European region: Analysis reported for change from baseline in DAS28 (ESR) at Day 85.||-0.18|-1.11|0.007
72534138|NCT01050998|144597351|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.41|STANDARD_ERROR_OF_MEAN|0.236||0.084|TWO_SIDED|95.0|-0.88|0.06|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including a treatment by visit interaction term. Differences \<0 favored mavrilimumab.|European region: Analysis reported for change from baseline in DAS28 (ESR) at Day 85.||0.06|-0.88|0.084
72534139|NCT01050998|144597351|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.73|STANDARD_ERROR_OF_MEAN|0.238||0.002|TWO_SIDED|95.0|-1.2|-0.26|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including a treatment by visit interaction term. Differences \<0 favored mavrilimumab.|European region: Analysis reported for change from baseline in DAS28 (ESR) at Day 85.||-0.26|-1.20|0.002
72534140|NCT01050998|144597351|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.12|STANDARD_ERROR_OF_MEAN|0.447||0.785|TWO_SIDED|95.0|-0.78|1.02|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including a treatment by visit interaction term. Differences \<0 favored mavrilimumab.|Japanese region: Analysis reported for change from baseline in DAS28 (CRP) at Day 85.||1.02|-0.78|0.785
72534141|NCT01050998|144597351|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.19|STANDARD_ERROR_OF_MEAN|0.465||0.014|TWO_SIDED|95.0|-2.13|-0.26|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including a treatment by visit interaction term. Differences \<0 favored mavrilimumab.|Japanese region: Analysis reported for change from baseline in DAS28 (CRP) at Day 85.||-0.26|-2.13|0.014
72534142|NCT01050998|144597351|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.04|STANDARD_ERROR_OF_MEAN|0.448||0.931|TWO_SIDED|95.0|-0.94|0.86|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including a treatment by visit interaction term. Differences \<0 favored mavrilimumab.|Japanese region: Analysis reported for change from baseline in DAS28 (CRP) at Day 85.||0.86|-0.94|0.931
72534143|NCT01050998|144597351|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.86|STANDARD_ERROR_OF_MEAN|0.465||0.07|TWO_SIDED|95.0|-1.8|0.07|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including a treatment by visit interaction term. Differences \<0 favored mavrilimumab.|Japanese region: Analysis reported for change from baseline in DAS28 (CRP) at Day 85.||0.07|-1.80|0.070
72626424|NCT00402987|144781759|SUPERIORITY_OR_OTHER_LEGACY|||||||0.219||95.0||||Analysis for Much Improvement|Regression, Logistic|Treatment as a factor||||||0.219
72626425|NCT00402987|144781759|SUPERIORITY_OR_OTHER_LEGACY|||||||0.095||95.0||||Analysis for Much Improvement|Regression, Logistic|Treatment as a factor||||||0.095
72626426|NCT00402987|144781759|SUPERIORITY_OR_OTHER_LEGACY|||||||0.463||95.0||||Analysis for Much Improvement|Regression, Logistic|Treatment as a factor||||||0.463
72626427|NCT00402987|144781759|SUPERIORITY_OR_OTHER_LEGACY|||||||0.038||95.0||||Analysis for Much Improvement|Regression, Logistic|Treatment as a factor||||||0.038
72626428|NCT00402987|144781760|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001||95.0|||||Regression, Logistic|Treatment as a factor||||||0.001
72626429|NCT00402987|144781760|SUPERIORITY_OR_OTHER_LEGACY|||||||0.008||95.0|||||Regression, Logistic|Treatment as a factor||||||0.008
72626430|NCT00402987|144781760|SUPERIORITY_OR_OTHER_LEGACY|||||||0.557||95.0|||||Regression, Logistic|Treatment as a factor||||||0.557
72626431|NCT00402987|144781761|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||Analysis at 12 hours|Regression, Logistic|Treatment as a factor||||||<0.001
72626432|NCT00402987|144781761|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002||95.0||||Analysis at 12 hours|Regression, Logistic|Treatment as a factor||||||0.002
72626433|NCT00402987|144781761|SUPERIORITY_OR_OTHER_LEGACY|||||||0.036||95.0||||Analysis at 12 hours|Regression, Logistic|Treatment as a factor||||||0.036
72534144|NCT01050998|144597351|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.08|STANDARD_ERROR_OF_MEAN|0.449||0.854|TWO_SIDED|95.0|-0.99|0.82|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including a treatment by visit interaction term. Differences \<0 favored mavrilimumab.|Japanese region: Analysis reported for change from baseline in DAS28 (ESR) at Day 85.||0.82|-0.99|0.854
72572542|NCT05091307|144672611|NON_INFERIORITY|The criterion for non-inferiority (NI) was the upper bound of the 2-sided 95% CI for the GMR was below 1.5.|Geometric Mean Ratio|1.28|||||TWO_SIDED|95.0|1.09|1.53|||ANOVA|||A/Victoria (H1N1): Based on analysis of variance (ANOVA) models, CIs around the difference (Group 2 \[control group\] minus Group 1 \[CoAd group\]) was calculated and back-transformed (by exponentiation: 2\^CI) to CIs around a geometric mean ratio (GMR: GMTControl/GMTCoAd).||1.53|1.09|
72572543|NCT05091307|144672611|NON_INFERIORITY|The criterion for NI was the upper bound of the 2-sided 95% CI for the GMR was below 1.5.|Geometric Mean Ratio|1.23|||||TWO_SIDED|95.0|1.05|1.45|||ANOVA|||A/Cambodia (H3N2): Based on analysis of variance (ANOVA) models, CIs around the difference (Group 2 \[control group\] minus Group 1 \[CoAd group\]) was calculated and back-transformed (by exponentiation: 2\^CI) to CIs around a geometric mean ratio (GMR: GMTControl/GMTCoAd).||1.45|1.05|
72572544|NCT05091307|144672611|NON_INFERIORITY|The criterion for NI was the upper bound of the 2-sided 95% CI for the GMR was below 1.5.|Geometric Mean Ratio|0.99|||||TWO_SIDED|95.0|0.84|1.19|||ANOVA|||B/Victoria (B/Victoria): Based on analysis of variance (ANOVA) models, CIs around the difference (Group 2 \[control group\] minus Group 1 \[CoAd group\]) was calculated and back-transformed (by exponentiation: 2\^CI) to CIs around a geometric mean ratio (GMR: GMTControl/GMTCoAd).||1.19|0.84|
72572545|NCT05091307|144672611|NON_INFERIORITY|The criterion for NI was the upper bound of the 2-sided 95% CI for the GMR was below 1.5.|Geometric Mean Ratio|1.03|||||TWO_SIDED|95.0|0.88|1.21|||ANOVA|||B/Phuket (B/Yamagata): Based on analysis of variance (ANOVA) models, CIs around the difference (Group 2 \[control group\] minus Group 1 \[CoAd group\]) was calculated and back-transformed (by exponentiation: 2\^CI) to CIs around a geometric mean ratio (GMR: GMTControl/GMTCoAd).||1.21|0.88|
72572546|NCT05091307|144672612|NON_INFERIORITY|The criterion for NI was the upper bound of the 2-sided 95% CI for the GMR was below 1.5.|Geometric Mean Ratio|1.11|||||TWO_SIDED|95.0|0.97|1.26|||ANOVA|||Based on analysis of variance (ANOVA) models, CIs around the difference (Group 2 \[control group\] minus Group 1 \[CoAd group\]) was calculated and back-transformed (by exponentiation: 2\^CI) to CIs around a geometric mean ratio (GMR: GMTControl/GMTCoAd).||1.26|0.97|
72572547|NCT02752906|144672670|NON_INFERIORITY|95% confidence interval (CI) of the difference was calculated from the Wilson Score Method without continuity correction. If the lower limit of the 2-sided 95% CI of the difference between the 2 percentage was \> -10%, the non- inferiority assumption was rejected.|Percentage Difference|5.0|||||TWO_SIDED|95.0|0.735|9.38||||||Serogroup A||9.38|0.735|
72572548|NCT02752906|144672670|NON_INFERIORITY|95% CI of the difference was calculated from the Wilson Score Method without continuity correction. If the lower limit of the 2-sided 95% CI of the difference between the 2 percentage was \> -10%, the non-inferiority assumption was rejected.|Percentage Difference|5.4|||||TWO_SIDED|95.0|2.16|8.76||||||Serogroup C||8.76|2.16|
72534145|NCT01050998|144597351|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.25|STANDARD_ERROR_OF_MEAN|0.468||0.011|TWO_SIDED|95.0|-2.19|-0.31|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including a treatment by visit interaction term. Differences \<0 favored mavrilimumab.|Japanese region: Analysis reported for change from baseline in DAS28 (ESR) at Day 85.||-0.31|-2.19|0.011
72534146|NCT01050998|144597351|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.448||0.271|TWO_SIDED|95.0|-1.4|0.4|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including a treatment by visit interaction term. Differences \<0 favored mavrilimumab.|Japanese region: Analysis reported for change from baseline in DAS28 (ESR) at Day 85.||0.40|-1.40|0.271
72534147|NCT01050998|144597351|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.03|STANDARD_ERROR_OF_MEAN|0.465||0.031|TWO_SIDED|95.0|-1.97|-0.1|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including a treatment by visit interaction term. Differences \<0 favored mavrilimumab.|Japanese region: Analysis reported for change from baseline in DAS28 (ESR) at Day 85.||-0.10|-1.97|0.031
72534148|NCT01050998|144597352|SUPERIORITY_OR_OTHER||Percent difference|7.0||||0.238|TWO_SIDED|95.0|-3.3|20.5|||Fisher Exact||95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|DAS28 (CRP): p-value was calculated using a two-tailed Fisher's exact test.||20.5|-3.3|0.238
72534149|NCT01050998|144597352|SUPERIORITY_OR_OTHER||Percent difference|14.8||||0.017|TWO_SIDED|95.0|2.8|29.7|||Fisher Exact||95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|DAS28 (CRP): p-value was calculated using a two-tailed Fisher's exact test.||29.7|2.8|0.017
72572549|NCT02752906|144672670|NON_INFERIORITY|95% CI of the difference was calculated from the Wilson Score Method without continuity correction. If the lower limit of the 2-sided 95% CI of the difference between the 2 percentage was \> -10%, the non-inferiority assumption was rejected.|Percentage Difference|1.8|||||TWO_SIDED|95.0|-0.907|4.55||||||Serogroup Y||4.55|-0.907|
72534150|NCT01050998|144597352|SUPERIORITY_OR_OTHER||Percent difference|11.1||||0.09|TWO_SIDED|95.0|0.0|25.4|||Fisher Exact||95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|DAS28 (CRP): p-value was calculated using a two-tailed Fisher's exact test.||25.4|0.0|0.090
72534151|NCT01050998|144597352|SUPERIORITY_OR_OTHER||Percent difference|15.8||||0.015|TWO_SIDED|95.0|2.9|31.0|||Fisher Exact||95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|DAS28 (CRP): p-value was calculated using a two-tailed Fisher's exact test.||31.0|2.9|0.015
72572550|NCT02752906|144672670|NON_INFERIORITY|95% CI of the difference was calculated from the Wilson Score Method without continuity correction. If the lower limit of the 2-sided 95% CI of the difference between the 2 percentage was \> -10%, the non-inferiority assumption was rejected.|Percentage Difference|7.4|||||TWO_SIDED|95.0|4.3|10.9||||||Serogroup W||10.9|4.30|
72572551|NCT00642694|144672717|SUPERIORITY|||||||0.05|||||||Mixed Models Analysis|||||||0.05
72572552|NCT03688282|144672726|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
72572553|NCT01659866|144672749|SUPERIORITY||||||<|0.05|||||||Fisher Exact|||||||<0.05
72534152|NCT01050998|144597352|SUPERIORITY_OR_OTHER||Percent difference|3.0||||0.412|TWO_SIDED|95.0|-4.2|14.0|||Fisher Exact||95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|DAS28 (ESR): p-value was calculated using a two-tailed Fisher's exact test.||14.0|-4.2|0.412
72534153|NCT01050998|144597352|SUPERIORITY_OR_OTHER||Percent difference|4.9||||0.237|TWO_SIDED|95.0|-2.9|16.4|||Fisher Exact||95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|DAS28 (ESR): p-value was calculated using a two-tailed Fisher's exact test.||16.4|-2.9|0.237
72534154|NCT01050998|144597352|SUPERIORITY_OR_OTHER||Percent difference|5.1||||0.231|TWO_SIDED|95.0|-2.8|16.8|||Fisher Exact||95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|DAS28 (ESR): p-value was calculated using a two-tailed Fisher's exact test.||16.8|-2.8|0.231
72534155|NCT01050998|144597352|SUPERIORITY_OR_OTHER||Percent difference|3.1||||0.406|TWO_SIDED|95.0|-4.1|14.4|||Fisher Exact||95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|DAS28 (ESR): p-value was calculated using a two-tailed Fisher's exact test.||14.4|-4.1|0.406
72534156|NCT01050998|144597353|SUPERIORITY_OR_OTHER||Percent difference|8.7||||0.182|TWO_SIDED|95.0|-2.7|24.4|||Fisher Exact||95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|European region (DAS28 \[CRP\]): p-value was calculated using a two-tailed Fisher's exact test.||24.4|-2.7|0.182
72534157|NCT01050998|144597353|SUPERIORITY_OR_OTHER||Percent difference|10.4||||0.11|TWO_SIDED|95.0|-1.2|25.5|||Fisher Exact||95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|European region (DAS28 \[CRP\]): p-value was calculated using a two-tailed Fisher's exact test.||25.5|-1.2|0.110
72534158|NCT01050998|144597353|SUPERIORITY_OR_OTHER||Percent difference|11.3||||0.104|TWO_SIDED|95.0|-0.6|26.9|||Fisher Exact||95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|European region (DAS28 \[CRP\]): p-value was calculated using a two-tailed Fisher's exact test.||26.9|-0.6|0.104
72534159|NCT01050998|144597353|SUPERIORITY_OR_OTHER||Percent difference|16.4||||0.016|TWO_SIDED|95.0|3.5|32.7|||Fisher Exact||95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|European region (DAS28 \[CRP\]): p-value was calculated using a two-tailed Fisher's exact test.||32.7|3.5|0.016
72534160|NCT01050998|144597353|SUPERIORITY_OR_OTHER||Percent difference|6.4||||0.115|TWO_SIDED|95.0|-1.0|19.3|||Fisher Exact||95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|European region (DAS28 \[ESR\]): p-value was calculated using a two-tailed Fisher's exact test.||19.3|-1.0|0.115
72534161|NCT01050998|144597353|SUPERIORITY_OR_OTHER||Percent difference|8.4||||0.052|TWO_SIDED|95.0|0.6|21.6|||Fisher Exact||95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|European region (DAS28 \[ESR\]): p-value was calculated using a two-tailed Fisher's exact test.||21.6|0.6|0.052
72534162|NCT01050998|144597353|SUPERIORITY_OR_OTHER||Percent difference|-0.7||||1|TWO_SIDED|95.0|-27.0|34.8|||Fisher Exact||95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|Japanese region (DAS28 \[CRP\]): p-value was calculated using a two-tailed Fisher's exact test.||34.8|-27.0|1.000
72534163|NCT01050998|144597353|SUPERIORITY_OR_OTHER||Percent difference|38.2||||0.059|TWO_SIDED|95.0|1.6|71.2|||Fisher Exact||95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|Japanese region (DAS28 \[CRP\]): p-value was calculated using a two-tailed Fisher's exact test.||71.2|1.6|0.059
72534164|NCT01050998|144597353|SUPERIORITY_OR_OTHER||Percent difference|10.5||||0.591|TWO_SIDED|95.0|-18.2|46.2|||Fisher Exact||95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|Japanese region (DAS28 \[CRP\]): p-value was calculated using a two-tailed Fisher's exact test.||46.2|-18.2|0.591
72534165|NCT01050998|144597353|SUPERIORITY_OR_OTHER||Percent difference|13.2||||0.57|TWO_SIDED|95.0|-16.6|51.4|||Fisher Exact||95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|Japanese region (DAS28 \[CRP\]): p-value was calculated using a two-tailed Fisher's exact test.||51.4|-16.6|0.570
72534166|NCT01050998|144597353|SUPERIORITY_OR_OTHER||Percent difference|-11.8||||0.529|TWO_SIDED|95.0|-35.0|22.7|||Fisher Exact||95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|Japanese region (DAS28 \[ESR\]): p-value was calculated using a two-tailed Fisher's exact test.||22.7|-35.0|0.529
72534167|NCT01050998|144597353|SUPERIORITY_OR_OTHER||Percent difference|-11.8||||1|TWO_SIDED|95.0|-37.5|22.6|||Fisher Exact||95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|Japanese region (DAS28 \[ESR\]): p-value was calculated using a two-tailed Fisher's exact test.||22.6|-37.5|1.000
72534168|NCT01050998|144597353|SUPERIORITY_OR_OTHER||Percent difference|-0.7||||1|TWO_SIDED|95.0|-27.0|34.8|||Fisher Exact||95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|Japanese region (DAS28 \[ESR\]): p-value was calculated using a two-tailed Fisher's exact test.||34.8|-27.0|1.000
72534169|NCT01050998|144597354|SUPERIORITY_OR_OTHER||Percent difference|||||0.604|||||||Log Rank|||Analysis reported for DAS28 (CRP) response.||||0.604
72534170|NCT01050998|144597354|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Log Rank|||Analysis reported for DAS28 (CRP) response.||||<0.001
72534171|NCT01050998|144597354|SUPERIORITY_OR_OTHER|||||||0.145|||||||Log Rank|||Analysis reported for DAS28 (CRP) response.||||0.145
72534172|NCT01050998|144597354|SUPERIORITY_OR_OTHER|||||||0.282|||||||Log Rank|||Analysis reported for DAS28 (ESR) response.||||0.282
72534173|NCT01050998|144597354|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Log Rank|||Analysis reported for DAS28 (ESR) response.||||<0.001
72534174|NCT01050998|144597354|SUPERIORITY_OR_OTHER|||||||0.047|||||||Log Rank|||Analysis reported for DAS28 (ESR) response.||||0.047
72534175|NCT01050998|144597355|SUPERIORITY_OR_OTHER||Percent difference|||||0.237|||||||Log Rank|||European region: Analysis reported for DAS28 (CRP) response.||||0.237
72534176|NCT01050998|144597355|SUPERIORITY_OR_OTHER|||||||0.005|||||||Log Rank|||European region: Analysis reported for DAS28 (CRP) response.||||0.005
72534177|NCT01050998|144597355|SUPERIORITY_OR_OTHER|||||||0.134|||||||Log Rank|||European region: Analysis reported for DAS28 (CRP) response.||||0.134
72534178|NCT01050998|144597355|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Log Rank|||European region: Analysis reported for DAS28 (CRP) response.||||<0.001
72534179|NCT01050998|144597355|SUPERIORITY_OR_OTHER|||||||0.265|||||||Log Rank|||Japanese region: Analysis reported for DAS28 (CRP) response.||||0.265
72534180|NCT01050998|144597355|SUPERIORITY_OR_OTHER|||||||0.013|||||||Log Rank|||Japanese region: Analysis reported for DAS28 (CRP) response.||||0.013
72534181|NCT01050998|144597355|SUPERIORITY_OR_OTHER|||||||0.952|||||||Log Rank|||Japanese region: Analysis reported for DAS28 (CRP) response.||||0.952
72572554|NCT01383135|144672754|SUPERIORITY_OR_OTHER_LEGACY|||||||0.034||||||GraphPad (GraphPad Software, San Diego, Calif) was used for the paired two-sample t test and was performed to compare SUVmax values. P \< .05 was considered to indicate a significant difference|t-test, 2 sided|||Comparison made between baseline tumor values and tumor values 6-weeks post-bevacizumab therapy||||.034
72572555|NCT04040322|144672760|SUPERIORITY||Least squares mean difference in change|-1.26||||0.421|TWO_SIDED|95.0|-4.34|1.82||Threshold for statistical significance was p \< 0.05|ANCOVA|||||1.82|-4.34|0.4210
72534182|NCT01050998|144597355|SUPERIORITY_OR_OTHER|||||||0.004|||||||Log Rank|||Japanese region: Analysis reported for DAS28 (CRP) response.||||0.004
72534183|NCT01050998|144597355|SUPERIORITY_OR_OTHER|||||||0.246|||||||Log Rank|||European region: Analysis reported for DAS28 (ESR) response.||||0.246
72534184|NCT01050998|144597355|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Log Rank|||European region: Analysis reported for DAS28 (ESR) response.||||<0.001
72534185|NCT01050998|144597355|SUPERIORITY_OR_OTHER|||||||0.126|||||||Log Rank|||European region: Analysis reported for DAS28 (ESR) response.||||0.126
72534186|NCT01050998|144597355|SUPERIORITY_OR_OTHER|||||||0.831|||||||Log Rank|||Japanese region: Analysis reported for DAS28 (ESR) response.||||0.831
72534187|NCT01050998|144597355|SUPERIORITY_OR_OTHER|||||||0.005|||||||Log Rank|||Japanese region: Analysis reported for DAS28 (ESR) response.||||0.005
72534188|NCT01050998|144597355|SUPERIORITY_OR_OTHER|||||||0.125|||||||Log Rank|||Japanese region: Analysis reported for DAS28 (ESR) response.||||0.125
72572556|NCT03056157|144672764|SUPERIORITY||Slope|-0.236||||0.03|TWO_SIDED|95.0|-3.34|-0.18|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for SDS scores, t(1519 )= -2.19, d = 0.15.||-0.18|-3.34|0.03
72572557|NCT03056157|144672764|SUPERIORITY||Slope|-8.97|||<|0.001|TWO_SIDED|95.0|-10.12|-6.11|||Mixed Models Analysis|||In a mixed model analysis of intent-to- treat data for SDS scores, t(160)= -15.74, d = 2.97.||-6.11|-10.12|<.001
72572558|NCT03056157|144672764|SUPERIORITY||Slope|-6.62|||<|0.001|TWO_SIDED|95.0|-8.35|-6.11|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for SDS scores, t(160) = -12.72, d = 1.86.||-6.11|-8.35|<0.001
72626434|NCT00402987|144781761|SUPERIORITY_OR_OTHER_LEGACY|||||||0.339||95.0||||Analysis at 12 hours|Regression, Logistic|Treatment as a factor||||||0.339
72626435|NCT00402987|144781761|SUPERIORITY_OR_OTHER_LEGACY|||||||1||95.0||||Analysis at 12 hours|Regression, Logistic|Treatment as a factor||||||1.000
72534189|NCT01050998|144597355|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Log Rank|||Japanese region: Analysis reported for DAS28 (ESR) response.||||<0.001
72626436|NCT00402987|144781761|SUPERIORITY_OR_OTHER_LEGACY|||||||0.401||95.0||||Analysis at 12 hours|Regression, Logistic|Treatment as a factor||||||0.401
72534190|NCT01050998|144597356|SUPERIORITY_OR_OTHER||Ratio of expected duration of response|1.15||||0.486|TWO_SIDED|95.0|0.78|1.69|||Exponential,Weibull and Log normal model||Ratio greater than (\>) 1 favored mavrilimumab.|Analysis reported for DAS28 (ESR) response.||1.69|0.78|0.486
72534191|NCT01050998|144597356|SUPERIORITY_OR_OTHER||Ratio of expected duration of response|1.54||||0.015|TWO_SIDED|95.0|1.09|2.18|||Exponential,Weibull and Log normal model||Ratio \>1 favored mavrilimumab.|Analysis reported for DAS28 (ESR) response.||2.18|1.09|0.015
72534192|NCT01050998|144597356|SUPERIORITY_OR_OTHER||Ratio of expected duration of response|1.65||||0.006|TWO_SIDED|95.0|1.15|2.36|||Exponential,Weibull and Log normal model||Ratio \>1 favored mavrilimumab.|Analysis reported for DAS28 (ESR) response.||2.36|1.15|0.006
72534193|NCT01050998|144597356|SUPERIORITY_OR_OTHER||Ratio of expected duration of response|2.09|||<|0.001|TWO_SIDED|95.0|1.49|2.93|||Exponential,Weibull and Log normal model||Ratio \>1 favored mavrilimumab.|Analysis reported for DAS28 (ESR) response.||2.93|1.49|<0.001
72534194|NCT01050998|144597356|SUPERIORITY_OR_OTHER||Ratio of expected duration of response|0.97||||0.906|TWO_SIDED|95.0|0.61|1.55|||Exponential,Weibull and Log normal model||Ratio \>1 favored mavrilimumab.|Analysis reported for DAS28 (CRP) response.||1.55|0.61|0.906
72534195|NCT01050998|144597356|SUPERIORITY_OR_OTHER||Ratio of expected duration of response|1.89|||<|0.001|TWO_SIDED|95.0|1.31|2.71|||Exponential,Weibull and Log normal model||Ratio \>1 favored mavrilimumab.|Analysis reported for DAS28 (CRP) response.||2.71|1.31|<0.001
72534196|NCT01050998|144597356|SUPERIORITY_OR_OTHER||Ratio of expected duration of response|1.26||||0.272|TWO_SIDED|95.0|0.83|1.91|||Exponential,Weibull and Log normal model||Ratio \>1 favored mavrilimumab.|Analysis reported for DAS28 (CRP) response.||1.91|0.83|0.272
72534197|NCT01050998|144597356|SUPERIORITY_OR_OTHER||Ratio of expected duration of response|1.91|||<|0.001|TWO_SIDED|95.0|1.34|2.72|||Exponential,Weibull and Log normal model||Ratio \>1 favored mavrilimumab.|Analysis reported for DAS28 (CRP) response.||2.72|1.34|<0.001
72534198|NCT01050998|144597357|SUPERIORITY_OR_OTHER||Percent difference|4.7||||0.589|TWO_SIDED|95.0|-12.1|22.0|||Fisher Exact||95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|ACR20: p-value was calculated using a two-tailed Fisher's exact test.||22.0|-12.1|0.589
72572559|NCT03056157|144672764|SUPERIORITY||Slope|-0.65||||0.49|TWO_SIDED|95.0|-2.13|0.86|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for SDS scores, t(1510) = -0.90, d = 0.05.||0.86|-2.13|0.49
72572560|NCT03056157|144672764|SUPERIORITY||Slope|1.1|||<|0.001|TWO_SIDED|95.0|0.06|2.17|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for SDS scores, t(1510) = 2.11, d = 0.11.||2.17|0.06|<0.001
72572561|NCT03056157|144672764|SUPERIORITY||Slope|1.75|||<|0.001|TWO_SIDED|95.0|0.75|2.81|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for SDS scores, t(1510) = 3.45, d = 0.18||2.81|0.75|<0.001
72572562|NCT03056157|144672765|SUPERIORITY||Odds Ratio (OR)|2.35||||0.03|TWO_SIDED|95.0|1.01|5.56|||Fisher Exact|||Odds ratio comparison of the proportions of participants who experienced probable recovery in SDS from baseline to post-treatment in AD-MIL versus PCT.||5.56|1.01|0.03
72572563|NCT03056157|144672765|SUPERIORITY||Odds Ratio (OR)|0.0||||0.01|TWO_SIDED|95.0|0.0|0.71|||Fisher Exact|||Odds ratio comparison of the proportion of participants who experienced improvement from baseline to post-treatment in SDS in AD-MIL versus PCT.||0.71|0|0.01
72572564|NCT03056157|144672765|SUPERIORITY||Odds Ratio (OR)|0.82||||0.69|TWO_SIDED|95.0|0.35|1.87|||Fisher Exact|||Odds ratio comparison of the proportion of participants who experienced no change in SDS from baseline to post-treatment in AD-MIL versus PCT.||1.87|0.35|.69
72572565|NCT03056157|144672765|SUPERIORITY||Odds Ratio (OR)|0.0||||0.5|TWO_SIDED|0.0|0.0|5.83|||Fisher Exact|||Odds ratio comparison of the proportion of participants who experienced deterioration in SDS from baseline to post-treatment in AD-MIL versus PCT.||5.83|0|0.50
72534199|NCT01050998|144597357|SUPERIORITY_OR_OTHER||Percent difference|20.2||||0.032||95.0|2.8|36.7|||Fisher Exact||95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|ACR20: p-value was calculated using a two-tailed Fisher's exact test.||36.7|2.8|0.032
72534200|NCT01050998|144597357|SUPERIORITY_OR_OTHER||Percent difference|0.5||||1|TWO_SIDED|95.0|-16.0|18.0|||Fisher Exact||95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|ACR20: p-value was calculated using a two-tailed Fisher's exact test.||18.0|-16.0|1.000
72534201|NCT01050998|144597357|SUPERIORITY_OR_OTHER||Percent difference|33.3|||<|0.001|TWO_SIDED|95.0|15.6|48.6|||Fisher Exact||95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|ACR20: p-value was calculated using a two-tailed Fisher's exact test.||48.6|15.6|<0.001
72534202|NCT01050998|144597357|SUPERIORITY_OR_OTHER||Percent difference|8.9||||0.212|TWO_SIDED|95.0|-3.5|23.6|||Fisher Exact||95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|ACR50: p-value was calculated using a two-tailed Fisher's exact test.||23.6|-3.5|0.212
72534203|NCT01050998|144597357|SUPERIORITY_OR_OTHER||Percent difference|18.7||||0.011|TWO_SIDED|95.0|4.8|34.0|||Fisher Exact||95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|ACR50: p-value was calculated using a two-tailed Fisher's exact test.||34.0|4.8|0.011
72534204|NCT01050998|144597357|SUPERIORITY_OR_OTHER||Percent difference|4.7||||0.446|TWO_SIDED|95.0|-7.0|19.1|||Fisher Exact||95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|ACR50: p-value was calculated using a two-tailed Fisher's exact test.||19.1|-7.0|0.446
72534205|NCT01050998|144597357|SUPERIORITY_OR_OTHER||Percent difference|22.1||||0.003|TWO_SIDED|95.0|7.6|37.8|||Fisher Exact||95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|ACR50: p-value was calculated using a two-tailed Fisher's exact test.||37.8|7.6|0.003
72534206|NCT01050998|144597357|SUPERIORITY_OR_OTHER||Percent difference|-1.3||||1|TWO_SIDED|95.0|-8.9|9.7|||Fisher Exact||95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|ACR70: p-value was calculated using a two-tailed Fisher's exact test.||9.7|-8.9|1.000
72534207|NCT01050998|144597357|SUPERIORITY_OR_OTHER||Percent difference|4.8||||0.317|TWO_SIDED|95.0|-4.1|17.5|||Fisher Exact||95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|ACR70: p-value was calculated using a two-tailed Fisher's exact test.||17.5|-4.1|0.317
72534208|NCT01050998|144597357|SUPERIORITY_OR_OTHER||Percent difference|0.8||||1|TWO_SIDED|95.0|-7.2|12.1|||Fisher Exact||95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|ACR70: p-value was calculated using a two-tailed Fisher's exact test.||12.1|-7.2|1.000
72534209|NCT01050998|144597357|SUPERIORITY_OR_OTHER||Percent difference|9.5||||0.106|TWO_SIDED|95.0|-0.5|23.5|||Fisher Exact||95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|ACR70: p-value was calculated using a two-tailed Fisher's exact test.||23.5|-0.5|0.106
72534210|NCT01050998|144597358|SUPERIORITY_OR_OTHER||Percent difference|1.0||||1|TWO_SIDED|95.0|-17.7|20.4|||Fisher Exact||95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|European region: ACR20 - p-value was calculated using a two-tailed Fisher's exact test.||20.4|-17.7|1.000
72534211|NCT01050998|144597358|SUPERIORITY_OR_OTHER||Percent difference|16.1||||0.12|TWO_SIDED|95.0|-3.1|34.4|||Fisher Exact|p-value was calculated using a two-tailed Fisher's exact test.|95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|European region: ACR20 - p-value was calculated using a two-tailed Fisher's exact test.||34.4|-3.1|0.120
72572566|NCT03056157|144672766|SUPERIORITY||Slope|-3.39||||0.35|TWO_SIDED|95.0|-10.57|3.79|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for B-IPF scores, t(326) = -0.93, d = 0.10.||3.79|-10.57|0.35
72534212|NCT01050998|144597358|SUPERIORITY_OR_OTHER||Percent difference|1.0||||1|TWO_SIDED|95.0|-17.7|20.4|||Fisher Exact|p-value was calculated using a two-tailed Fisher's exact test.|95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|European region: ACR20 - p-value was calculated using a two-tailed Fisher's exact test.||20.4|-17.7|1.000
72534213|NCT01050998|144597358|SUPERIORITY_OR_OTHER||Percent difference|29.2||||0.005|TWO_SIDED|95.0|9.7|46.1|||Fisher Exact|p-value was calculated using a two-tailed Fisher's exact test.|95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|European region: ACR20 - p-value was calculated using a two-tailed Fisher's exact test.||46.1|9.7|0.005
72534214|NCT01050998|144597358|SUPERIORITY_OR_OTHER||Percent difference|20.9||||0.382|TWO_SIDED|95.0|-16.4|55.9|||Fisher Exact|p-value was calculated using a two-tailed Fisher's exact test.|95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|Japanese region: ACR20 - p-value was calculated using a two-tailed Fisher's exact test.||55.9|-16.4|0.382
72534215|NCT01050998|144597358|SUPERIORITY_OR_OTHER||Percent difference|39.0||||0.087|TWO_SIDED|95.0|-2.7|69.6|||Fisher Exact|p-value was calculated using a two-tailed Fisher's exact test.|95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|Japanese region: ACR20 - p-value was calculated using a two-tailed Fisher's exact test.||69.6|-2.7|0.087
72534216|NCT01050998|144597358|SUPERIORITY_OR_OTHER||Percent difference|-1.3||||1|TWO_SIDED|95.0|-33.7|35.7|||Fisher Exact|p-value was calculated using a two-tailed Fisher's exact test.|95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|Japanese region: ACR20 - p-value was calculated using a two-tailed Fisher's exact test.||35.7|-33.7|1.000
72534217|NCT01050998|144597358|SUPERIORITY_OR_OTHER||Percent difference|51.5||||0.028|TWO_SIDED|95.0|8.2|77.0|||Fisher Exact|p-value was calculated using a two-tailed Fisher's exact test.|95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|Japanese region: ACR20 - p-value was calculated using a two-tailed Fisher's exact test.||77.0|8.2|0.028
72534218|NCT01050998|144597358|SUPERIORITY_OR_OTHER||Percent difference|11.1||||0.175|TWO_SIDED|95.0|-2.9|27.9|||Fisher Exact|p-value was calculated using a two-tailed Fisher's exact test.|95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|European region: ACR50 - p-value was calculated using a two-tailed Fisher's exact test.||27.9|-2.9|0.175
72572567|NCT03056157|144672766|SUPERIORITY||Slope|-8.64||||0.001|TWO_SIDED|95.0|-13.83|-3.44|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for BIPF scores, t(116) = -3.27, d = 0.61.||-3.44|-13.83|0.001
72572568|NCT03056157|144672766|SUPERIORITY||Slope|-5.25||||0.04|TWO_SIDED|95.0|-10.21|-0.29|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for B-IPF scores, t(116) = -2.08, d = 0.39.||-0.29|-10.21|0.04
72408073|NCT03238911|144324437|SUPERIORITY||Risk Difference (RD)|-11.9||||0.005|TWO_SIDED|95.0|-20.1|-3.6|||Cochran-Mantel-Haenszel|||The rate difference with 95% Newcombe confidence interval, adjusted for stratum using the Cochran-Mantel-Haenszel method, could not be estimated due to lack of events. Thus, the unadjusted treatment difference is presented together with 95% Wald-based confidence interval. The p-value is based on the Cochran-Mantel-Haenszel statistics.||-3.6|-20.1|0.0050
72408074|NCT06893809|144324438|SUPERIORITY||Median Difference (Net)|10.0|STANDARD_DEVIATION|5.0||0.05|TWO_SIDED|95.0|10.0|20.0|||Kruskal-Wallis|||Sixty male patients scheduled for TURP surgery were divided into three equal groups. The results were evaluated at a 95% confidence interval, with significance set at p \< 0.05. This was achieved using SPSS 15.0. Between-group comparisons were performed using One-way ANOVA, Kruskal-Wallis, Wilcoxon Signed Ranks, and Friedman tests. Within-group comparisons used Wilcoxon Signed Ranks tests, and Friedman tests were used for differences over time.||20|10|0.05
72408075|NCT06893809|144324438|SUPERIORITY||Mean Difference (Final Values)|0.0|STANDARD_DEVIATION|0.0|>|0.05|TWO_SIDED|95.0|0.0|0.0||No adjustment for multiple comparisons was applied. Non-parametric method used due to ordinal scale structure.|Kruskal-Wallis||Patient and surgeon satisfaction were compared across study arms.|The aim of this analysis is to compare the three groups in terms of patient and surgeon satisfaction using a superiority approach. The null hypothesis is that there is no difference in satisfaction scores between the groups. Statistical significance was set at p \< 0.05.||0|0|>0.05
72408076|NCT06893809|144324440|SUPERIORITY||Mean Difference (Final Values)|1.05||||0.05|TWO_SIDED|95.0|0.5|1.6|||Kruskal-Wallis|Non-parametric test used due to ordinal scale and non-normal distribution.|Sensory block levels compared across study arms using numerical dermatomal codes.|||1.6|0.5|0.05
72408077|NCT06893809|144324442|SUPERIORITY||Mean Difference (Final Values)|0.5|STANDARD_ERROR_OF_MEAN|0.22|<|0.05|TWO_SIDED|95.0|0.07|0.93|||Kruskal-Wallis||Dermatomal regression levels were compared across groups at 60 minutes.|||0.93|0.07|<0.05
72408078|NCT04524403|144324449|SUPERIORITY||Least Squares Mean Difference|0.24||||0.787|TWO_SIDED|95.0|-1.52|2.01|||Mixed Models Analysis|||||2.01|-1.52|0.7870
72534219|NCT01050998|144597358|SUPERIORITY_OR_OTHER||Percent difference|17.3||||0.026|TWO_SIDED|95.0|2.4|34.1|||Fisher Exact|p-value was calculated using a two-tailed Fisher's exact test.|95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|European region: ACR50 - p-value was calculated using a two-tailed Fisher's exact test.||34.1|2.4|0.026
72534220|NCT01050998|144597358|SUPERIORITY_OR_OTHER||Percent difference|8.5||||0.271|TWO_SIDED|95.0|-5.1|24.9|||Fisher Exact|p-value was calculated using a two-tailed Fisher's exact test.|95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|European region: ACR50 - p-value was calculated using a two-tailed Fisher's exact test.||24.9|-5.1|0.271
72572569|NCT03056157|144672766|SUPERIORITY||Slope|-5.17||||0.08|TWO_SIDED|95.0|-10.86|0.52|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for B-IPF scores, t(326) = -1.79, d = 0.20.||0.52|-10.86|0.08
72534221|NCT01050998|144597358|SUPERIORITY_OR_OTHER||Percent difference|18.8||||0.021|TWO_SIDED|95.0|3.4|36.0|||Fisher Exact|p-value was calculated using a two-tailed Fisher's exact test.|95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|European region: ACR50 - p-value was calculated using a two-tailed Fisher's exact test.||36.0|3.4|0.021
72534222|NCT01050998|144597358|SUPERIORITY_OR_OTHER||Percent difference|-0.7||||1|TWO_SIDED|95.0|-27.0|34.8|||Fisher Exact|p-value was calculated using a two-tailed Fisher's exact test.|95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|Japanese region: ACR50 - p-value was calculated using a two-tailed Fisher's exact test.||34.8|-27.0|1.000
72572570|NCT03056157|144672766|SUPERIORITY||Slope|-5.64||||0.007|TWO_SIDED|95.0|-9.72|-1.57|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for B-IPF scores, t(326) = -2.72, d = 0.30.||-1.57|-9.72|0.007
72408079|NCT04524403|144324449|SUPERIORITY||Least Squares Mean Difference|0.75||||0.4018|TWO_SIDED|95.0|-1.01|2.51|||Mixed Models Analysis|||||2.51|-1.01|0.4018
72408080|NCT04524403|144324450|SUPERIORITY||Least Squares Mean Difference|0.5||||0.5228|TWO_SIDED|95.0|-1.03|2.02|||Mixed Models Analysis|||||2.02|-1.03|0.5228
72408081|NCT04524403|144324451|SUPERIORITY||Odds Ratio (OR)|1.781||||0.2537|TWO_SIDED|95.0|0.661|4.802|||Regression, Logistic|||||4.802|0.661|0.2537
72408082|NCT04524403|144324451|SUPERIORITY||Odds Ratio (OR)|0.916||||0.874|TWO_SIDED|95.0|0.308|2.722|||Regression, Logistic|||||2.722|0.308|0.8740
72408083|NCT04524403|144324452|SUPERIORITY||Least Squares Mean Difference|0.0||||0.987|TWO_SIDED|95.0|-0.021|0.021|||Mixed Models Analysis|||||0.021|-0.021|0.9870
72408084|NCT04524403|144324452|SUPERIORITY||Least Squares Mean Difference|0.008||||0.4624|TWO_SIDED|95.0|-0.013|0.029|||Mixed Models Analysis|||||0.029|-0.013|0.4624
72408085|NCT00368940|144324456|SUPERIORITY||Cohen D at week 12|0.6||||0.005|TWO_SIDED|95.0|0.13|1.06|||Mixed Models Analysis|||||1.06|0.13|0.005
72408086|NCT00368940|144324457|SUPERIORITY||Cohen D at week 12|0.67||||0.001|TWO_SIDED|95.0|0.2|1.14|||Mixed Models Analysis|||||1.14|0.20|0.001
72408087|NCT00368940|144324458|SUPERIORITY|||||||0.0268|||||||Wilcoxon (Mann-Whitney)|||||||0.0268
72408088|NCT00368940|144324459|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
72408089|NCT01513317|144324502|SUPERIORITY_OR_OTHER||Difference in proportions|0.082||||0.271|TWO_SIDED|95.0|-0.03|0.2|||Cochran-Mantel-Haenszel||The estimated parameter is the difference in proportion of participants who had a reduction in RBC transfusion to treat the anemia of MDS.|||0.20|-0.03|0.271
72572571|NCT03056157|144672766|SUPERIORITY||Slope|-0.47||||0.82|TWO_SIDED|95.0|-4.44|3.5|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for B-IPF scores, t(326) = -0.23, d = 0.03.||3.50|-4.44|0.82
72572572|NCT03056157|144672767|SUPERIORITY||Slope|-0.6||||0.75|TWO_SIDED|95.0|-4.68|3.36|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for SDS scores for the COVID-19 cohort, t(373) = -0.32, d = 0.03.||3.36|-4.68|0.75
72572573|NCT03056157|144672767|SUPERIORITY||Slope|-9.12|||<|0.001|TWO_SIDED|95.0|-12.12|-6.12|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for SDS scores for the COVID-19 cohort, t(37) = -6.01, d = 1.97.||-6.12|-12.12|<0.001
72572574|NCT03056157|144672767|SUPERIORITY||Slope|-8.72|||<|0.001|TWO_SIDED|95.0|-11.16|-5.76|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for SDS scores for the COVID-19 cohort, t(37) = -6.11, d = 2.01.||-5.76|-11.16|<0.001
72572575|NCT03056157|144672767|SUPERIORITY||Slope|-2.28||||0.56|TWO_SIDED|95.0|-10.08|5.52|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for SDS scores for the COVID-19 cohort, t(373) = -0.59, d = 0.06.||5.52|-10.08|0.56
72534223|NCT01050998|144597358|SUPERIORITY_OR_OTHER||Percent difference|25.7||||0.283|TWO_SIDED|95.0|-8.8|63.2|||Fisher Exact|p-value was calculated using a two-tailed Fisher's exact test.|95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|Japanese region: ACR50 - p-value was calculated using a two-tailed Fisher's exact test.||63.2|-8.8|0.283
72534224|NCT01050998|144597358|SUPERIORITY_OR_OTHER||Percent difference|-11.8||||0.529|TWO_SIDED|95.0|-35.0|22.7|||Fisher Exact|p-value was calculated using a two-tailed Fisher's exact test.|95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|Japanese region: ACR50 - p-value was calculated using a two-tailed Fisher's exact test.||22.7|-35.0|0.529
72534225|NCT01050998|144597358|SUPERIORITY_OR_OTHER||Percent difference|38.2||||0.059|TWO_SIDED|95.0|1.6|71.2|||Fisher Exact|p-value was calculated using a two-tailed Fisher's exact test.|95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|Japanese region: ACR50 - p-value was calculated using a two-tailed Fisher's exact test.||71.2|1.6|0.059
72534226|NCT01050998|144597358|SUPERIORITY_OR_OTHER||Percent difference|1.1||||1|TWO_SIDED|95.0|-7.0|14.2|||Fisher Exact|p-value was calculated using a two-tailed Fisher's exact test.|95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|European region: ACR70 - p-value was calculated using a two-tailed Fisher's exact test.||14.2|-7.0|1.000
72534227|NCT01050998|144597358|SUPERIORITY_OR_OTHER||Percent difference|5.8||||0.242|TWO_SIDED|95.0|-3.7|19.4|||Fisher Exact|p-value was calculated using a two-tailed Fisher's exact test.|95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|European region: ACR70 - p-value was calculated using a two-tailed Fisher's exact test.||19.4|-3.7|0.242
72534228|NCT01050998|144597358|SUPERIORITY_OR_OTHER||Percent difference|3.7||||0.41|TWO_SIDED|95.0|-5.1|16.9|||Fisher Exact|p-value was calculated using a two-tailed Fisher's exact test.|95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|European region: ACR70 - p-value was calculated using a two-tailed Fisher's exact test.||16.9|-5.1|0.410
72534229|NCT01050998|144597358|SUPERIORITY_OR_OTHER||Percent difference|13.9||||0.03|TWO_SIDED|95.0|2.7|29.5|||Fisher Exact|p-value was calculated using a two-tailed Fisher's exact test.|95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|European region: ACR70 - p-value was calculated using a two-tailed Fisher's exact test.||29.5|2.7|0.030
72534230|NCT01050998|144597358|SUPERIORITY_OR_OTHER||Percent difference|-11.8||||0.529|TWO_SIDED|95.0|-35.0|22.7|||Fisher Exact|p-value was calculated using a two-tailed Fisher's exact test.|95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|Japanese region: ACR70 - p-value was calculated using a two-tailed Fisher's exact test.||22.7|-35.0|0.529
72534231|NCT01050998|144597358|SUPERIORITY_OR_OTHER||Percent difference|0.7||||1|TWO_SIDED|95.0|-26.7|39.5|||Fisher Exact|p-value was calculated using a two-tailed Fisher's exact test.|95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|Japanese region: ACR70 - p-value was calculated using a two-tailed Fisher's exact test.||39.5|-26.7|1.000
72534232|NCT01050998|144597358|SUPERIORITY_OR_OTHER||Percent difference|-11.8||||1|TWO_SIDED|95.0|-37.5|22.6|||Fisher Exact|p-value was calculated using a two-tailed Fisher's exact test.|95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|Japanese region: ACR70 - p-value was calculated using a two-tailed Fisher's exact test.||22.6|-37.5|1.000
72534233|NCT01050998|144597360|SUPERIORITY_OR_OTHER||Adjusted Mean difference|14.05|STANDARD_ERROR_OF_MEAN|7.162||0.051|TWO_SIDED|95.0|-0.05|28.15|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including a treatment by visit interaction term. Differences \<0 favored mavrilimumab.|||28.15|-0.05|0.051
72534234|NCT01050998|144597360|SUPERIORITY_OR_OTHER||Adjusted Mean difference|21.23|STANDARD_ERROR_OF_MEAN|7.028||0.003|TWO_SIDED|95.0|7.39|35.07|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including a treatment by visit interaction term. Differences \<0 favored mavrilimumab.|||35.07|7.39|0.003
72534235|NCT01050998|144597360|SUPERIORITY_OR_OTHER||Adjusted Mean difference|7.09|STANDARD_ERROR_OF_MEAN|7.136||0.322|TWO_SIDED|95.0|-6.96|21.14|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including a treatment by visit interaction term. Differences \<0 favored mavrilimumab.|||21.14|-6.96|0.322
72534236|NCT01050998|144597360|SUPERIORITY_OR_OTHER||Adjusted Mean difference|32.03|STANDARD_ERROR_OF_MEAN|7.085|<|0.001|TWO_SIDED|95.0|18.08|45.98|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including a treatment by visit interaction term. Differences \<0 favored mavrilimumab.|||45.98|18.08|<0.001
72626437|NCT00402987|144781761|SUPERIORITY_OR_OTHER_LEGACY|||||||0.003||95.0||||Analysis at 24 hours|Regression, Logistic|Treatment as a factor||||||0.003
72534237|NCT01050998|144597361|SUPERIORITY_OR_OTHER||Adjusted Mean difference|14.49|STANDARD_ERROR_OF_MEAN|7.981||0.071|TWO_SIDED|95.0|-1.24|30.22|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including a treatment by visit interaction term. Differences \<0 favored mavrilimumab.|Analysis reported for European region.||30.22|-1.24|0.071
72534238|NCT01050998|144597361|SUPERIORITY_OR_OTHER||Adjusted mean difference|19.43|STANDARD_ERROR_OF_MEAN|7.798||0.013|TWO_SIDED|95.0|4.06|34.8|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including a treatment by visit interaction term. Differences \<0 favored mavrilimumab.|Analysis reported for European region.||34.80|4.06|0.013
72534239|NCT01050998|144597361|SUPERIORITY_OR_OTHER||Adjusted mean difference|7.84|STANDARD_ERROR_OF_MEAN|7.873||0.32|TWO_SIDED|95.0|-7.68|23.36|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including a treatment by visit interaction term. Differences \<0 favored mavrilimumab.|Analysis reported for European region.||23.36|-7.68|0.320
72572576|NCT03056157|144672767|SUPERIORITY||Slope|4.2||||0.22|TWO_SIDED|95.0|-0.24|10.92|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for SDS scores for the COVID-19 cohort, t(373) = 1.25, d = 0.13.||10.92|-0.24|0.22
72572577|NCT03056157|144672767|SUPERIORITY||Slope|6.6||||0.002|TWO_SIDED|95.0|2.52|10.69|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for SDS scores for the COVID-19 cohort, t(373) = 3.18, d = 0.33.||10.69|2.52|0.002
72534240|NCT01050998|144597361|SUPERIORITY_OR_OTHER||Adjusted mean difference|31.37|STANDARD_ERROR_OF_MEAN|7.873|<|0.001|TWO_SIDED|95.0|15.85|46.89|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including a treatment by visit interaction term. Differences \<0 favored mavrilimumab.|Analysis reported for European region.||46.89|15.85|<0.001
72534241|NCT01050998|144597361|SUPERIORITY_OR_OTHER||Adjusted mean difference|12.11|STANDARD_ERROR_OF_MEAN|17.089||0.483|TWO_SIDED|95.0|-22.41|46.64|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including a treatment by visit interaction term. Differences \<0 favored mavrilimumab.|Analysis reported for Japanese region.||46.64|-22.41|0.483
72534242|NCT01050998|144597361|SUPERIORITY_OR_OTHER||Adjusted mean difference|31.24|STANDARD_ERROR_OF_MEAN|17.089||0.075|TWO_SIDED|95.0|-3.28|65.77|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including a treatment by visit interaction term. Differences \<0 favored mavrilimumab.|Analysis reported for Japanese region.||65.77|-3.28|0.075
72572578|NCT03056157|144672768|SUPERIORITY||Slope|0.48||||0.92|TWO_SIDED|95.0|-9.6|10.69|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for PCL-5 scores for the COVID-19 cohort, t(367) = 0.10, d = 0.01.||10.69|-9.60|0.92
72534243|NCT01050998|144597361|SUPERIORITY_OR_OTHER||Adjusted mean difference|4.22|STANDARD_ERROR_OF_MEAN|17.872||0.815|TWO_SIDED|95.0|-31.89|40.32|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including a treatment by visit interaction term. Differences \<0 favored mavrilimumab.|Analysis reported for Japanese region.||40.32|-31.89|0.815
72534244|NCT01050998|144597361|SUPERIORITY_OR_OTHER||Adjusted mean difference|36.11|STANDARD_ERROR_OF_MEAN|17.089||0.041|TWO_SIDED|95.0|1.58|70.63|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including a treatment by visit interaction term. Differences \<0 favored mavrilimumab.|Analysis reported for Japanese region.||70.63|1.58|0.041
72534245|NCT00370994|144597431|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||Comparisons were made between groups and within the group between baseline and different time points.|Repeated measures ANOVA.|||||||<0.001
72408090|NCT01513317|144324503|SUPERIORITY_OR_OTHER||Difference in LS means|0.07||||0.872|TWO_SIDED|95.0|-0.79|0.93|||ANCOVA||The estimated parameter is the difference in LS means of the change from baseline hemoglobin levels at Week 13.|||0.93|-0.79|0.872
72534246|NCT00370994|144597432|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001||95.0||||There were significant differences in Oswestry Disability Index between both groups|Repeated measures of ANOVA|||||||0.001
72572579|NCT03056157|144672768|SUPERIORITY||Slope|-16.08|||<|0.001|TWO_SIDED|95.0|-23.64|-8.52|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for PCL-5 scores for the COVID-19 cohort, t(37) = -4.23, d = 1.39.||-8.52|-23.64|<0.001
72626438|NCT00402987|144781761|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002||95.0||||Analysis at 24 hours|Regression, Logistic|Treatment as a factor||||||0.002
72626439|NCT00402987|144781761|SUPERIORITY_OR_OTHER_LEGACY|||||||0.223||95.0||||Analysis at 24 hours|Regression, Logistic|Treatment as a factor||||||0.223
72626440|NCT00402987|144781761|SUPERIORITY_OR_OTHER_LEGACY|||||||0.198||95.0||||Analysis at 24 hours|Regression, Logistic|Treatment as a factor||||||0.198
72626441|NCT00402987|144781761|SUPERIORITY_OR_OTHER_LEGACY|||||||0.604||95.0||||Analysis at 24 hours|Regression, Logistic|Treatment as a factor||||||0.604
72626442|NCT00402987|144781761|SUPERIORITY_OR_OTHER_LEGACY|||||||0.117||95.0||||Analysis at 24 hours|Regression, Logistic|Treatment as a factor||||||0.117
72626443|NCT00402987|144781764|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001||95.0|||||Regression, Logistic|Treatment as a factor||||||0.001
72626444|NCT00402987|144781764|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||Regression, Logistic|Treatment as a factor||||||<0.001
72626445|NCT00402987|144781764|SUPERIORITY_OR_OTHER_LEGACY|||||||0.025||95.0|||||Regression, Logistic|Treatment as a factor||||||0.025
72626446|NCT00402987|144781764|SUPERIORITY_OR_OTHER_LEGACY|||||||0.539||95.0|||||Regression, Logistic|Treatment as a factor||||||0.539
72626447|NCT00402987|144781764|SUPERIORITY_OR_OTHER_LEGACY|||||||0.329||95.0|||||Regression, Logistic|Treatment as a factor||||||0.329
72626448|NCT00402987|144781764|SUPERIORITY_OR_OTHER_LEGACY|||||||0.171||95.0|||||Regression, Logistic|Treatment as a factor||||||0.171
72626449|NCT00402987|144781765|SUPERIORITY_OR_OTHER_LEGACY|||||||0.007||95.0|||||Regression, Logistic|Treatment as a factor||||||0.007
72626450|NCT00402987|144781765|SUPERIORITY_OR_OTHER_LEGACY|||||||0.244||95.0|||||Regression, Logistic|Treatment as a factor||||||0.244
72626451|NCT00402987|144781765|SUPERIORITY_OR_OTHER_LEGACY|||||||0.096||95.0|||||Regression, Logistic|Treatment as a factor||||||0.096
72626452|NCT00402987|144781765|SUPERIORITY_OR_OTHER_LEGACY|||||||0.579||95.0|||||Regression, Logistic|Treatment as a factor||||||0.579
72626453|NCT00402987|144781765|SUPERIORITY_OR_OTHER_LEGACY|||||||0.277||95.0|||||Regression, Logistic|Treatment as a factor||||||0.277
72626454|NCT00402987|144781765|SUPERIORITY_OR_OTHER_LEGACY|||||||0.649||95.0|||||Regression, Logistic|Treatment as a factor||||||0.649
72626455|NCT00402987|144781766|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|15.4|||<|0.001||95.0|7.5|23.2||Analysis of Effectiveness|Generalized linear model|Treatment as a fixed effect||||23.2|7.5|<0.001
72626456|NCT00402987|144781766|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|14.4||||0.003||95.0|4.9|24.0||Analysis of Effectiveness|Generalized linear model|Treatment as a fixed effect||||24.0|4.9|0.003
72626457|NCT00402987|144781766|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|8.2||||0.096||95.0|-1.5|17.8||Analysis of Effectiveness|Generalized linear model|Treatment as a fixed effect||||17.8|-1.5|0.096
72626458|NCT00402987|144781766|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|7.2||||0.141||95.0|-2.4|16.8||Analysis of Effectiveness|Generalized linear model|Treatment as a fixed effect||||16.8|-2.4|0.141
72626459|NCT00402987|144781766|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.9||||0.849||95.0|-8.6|10.5||Analysis of Effectiveness|Generalized linear model|Treatment as a fixed effect||||10.5|-8.6|0.849
72626460|NCT00402987|144781766|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|6.3||||0.266||95.0|-4.8|17.4||Analysis of Effectiveness|Generalized linear model|Treatment as a fixed effect||||17.4|-4.8|0.266
72534247|NCT04246593|144597435|OTHER|We used generalized linear mixed model (GLMM) with random intercept to control for clustering within sites. In order to further explore the intervention effect, we fit GLMMs that adjust for (1) baseline dietary intake and (2) race and baseline income.|Mean Difference (Final Values)|-0.11|STANDARD_ERROR_OF_MEAN|0.52||0.84|TWO_SIDED|||||P-value calculated for the mean difference between the user and non-user groups.|GLMM|||||||0.84
72534248|NCT04246593|144597436|OTHER|We used generalized linear mixed model (GLMM) with random intercept to control for clustering within sites.|Median Difference (Net)|-0.59|STANDARD_ERROR_OF_MEAN|1.15||0.61|TWO_SIDED|||||P-value calculated for the mean difference between change in BMI for intervention and control groups.|GLMM|||||||0.61
72534249|NCT04246593|144597437|OTHER|We used generalized linear mixed model (GLMM) with random intercept to control for clustering within sites.|Mean Difference (Net)|-28.02|STANDARD_ERROR_OF_MEAN|43.31||0.53|TWO_SIDED|||||P-value calculated for the mean difference in change scores between the intervention and control groups.|GLMM|||||||0.53
72534250|NCT04246593|144597438|OTHER|We used generalized linear mixed model (GLMM) with random intercept to control for clustering within sites.|Mean Difference (Net)|-0.53|STANDARD_ERROR_OF_MEAN|1.65||0.75|TWO_SIDED|||||The p-value applies to the mean difference in mean self-efficacy change scores between the intervention and control groups.|GLMM|||||||0.75
72534251|NCT04246593|144597439|OTHER|We used generalized linear mixed model (GLMM) with random intercept to control for clustering within sites.|Mean Difference (Net)|-0.56|STANDARD_ERROR_OF_MEAN|1.13||0.63|TWO_SIDED|||||P-value applies to the mean difference in mean total barriers score change between the intervention and control groups.|GLMM|||||||0.63
72534252|NCT02369874|144597446|SUPERIORITY||Hazard Ratio (HR)|1.04||||0.7624|TWO_SIDED|95.0|0.85|1.26|||Log Rank|||||1.26|0.85|0.7624
72534253|NCT02369874|144597446|SUPERIORITY||Hazard Ratio (HR)|0.88||||0.1993|TWO_SIDED|95.0|0.72|1.08|||Log Rank|||||1.08|0.72|0.1993
72534254|NCT02369874|144597447|SUPERIORITY||Hazard Ratio (HR)|0.92||||0.459|TWO_SIDED|95.0|0.73|1.17|||Log Rank|||||1.17|0.73|0.4590
72534255|NCT02369874|144597447|SUPERIORITY||Hazard Ratio (HR)|1.08|||||TWO_SIDED|95.0|0.85|1.36||||||||1.36|0.85|
72534256|NCT02369874|144597448|SUPERIORITY||Hazard Ratio (HR)|0.93|||||TWO_SIDED|95.0|0.63|1.39||||||||1.39|0.63|
72534257|NCT02369874|144597449|SUPERIORITY||Hazard Ratio (HR)|1.09|||||TWO_SIDED|95.0|0.9|1.33||||||||1.33|0.90|
72534258|NCT02369874|144597449|SUPERIORITY||Hazard Ratio (HR)|1.02|||||TWO_SIDED|95.0|0.84|1.25||||||||1.25|0.84|
72534259|NCT02369874|144597450|SUPERIORITY||Odds Ratio (OR)|1.07|||||TWO_SIDED|95.0|0.67|1.7||||||||1.70|0.67|
72534260|NCT02369874|144597450|SUPERIORITY||Odds Ratio (OR)|1.05|||||TWO_SIDED|95.0|0.66|1.68||||||||1.68|0.66|
72534261|NCT02369874|144597452|SUPERIORITY||Odds Ratio (OR)|1.01|||||TWO_SIDED|95.0|0.67|1.52||||||6 Month analysis||1.52|0.67|
72534262|NCT02369874|144597452|SUPERIORITY||Odds Ratio (OR)|0.96|||||TWO_SIDED|95.0|0.64|1.46||||||6 Month analysis||1.46|0.64|
72534263|NCT02369874|144597452|SUPERIORITY||Odds Ratio (OR)|1.12|||||TWO_SIDED|95.0|0.72|1.75||||||12 Month analysis||1.75|0.72|
72534264|NCT02369874|144597452|SUPERIORITY||Odds Ratio (OR)|1.0|||||TWO_SIDED|95.0|0.63|1.57||||||12 Month analysis||1.57|0.63|
72534265|NCT02369874|144597455|SUPERIORITY||Hazard Ratio (HR)|0.96|||||TWO_SIDED|95.0|0.76|1.21||||||||1.21|0.76|
72534266|NCT02369874|144597456|SUPERIORITY||Odds Ratio (OR)|1.33|||||TWO_SIDED|95.0|0.74|2.39||||||||2.39|0.74|
72534267|NCT00634933|144597471|SUPERIORITY_OR_OTHER|||||||0.061|TWO_SIDED||||||Cochran-Mantel-Haenszel|||A 2-sided Cochran-Mantel-Haenszel test (CMH), stratified by prior anti-tumor necrosis factor (anti-TNF) use and geographic region, was used.||||0.061
72534268|NCT00634933|144597471|SUPERIORITY_OR_OTHER|||||||0.12|TWO_SIDED||||||Cochran-Mantel-Haenszel|||A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.120
72534269|NCT00634933|144597472|SUPERIORITY_OR_OTHER|||||||0.57|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 2: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.570
72534270|NCT00634933|144597472|SUPERIORITY_OR_OTHER|||||||0.2|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 2: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.200
72534271|NCT00634933|144597472|SUPERIORITY_OR_OTHER|||||||0.616|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 4: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.616
72534272|NCT00634933|144597472|SUPERIORITY_OR_OTHER|||||||0.671|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 4: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.671
72534273|NCT00634933|144597472|SUPERIORITY_OR_OTHER|||||||0.108|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 8: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.108
72534274|NCT00634933|144597472|SUPERIORITY_OR_OTHER|||||||0.174|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 8: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.174
72534275|NCT00634933|144597472|SUPERIORITY_OR_OTHER|||||||0.01|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 12: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.010
72534276|NCT00634933|144597472|SUPERIORITY_OR_OTHER|||||||0.029|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 12: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.029
72534277|NCT00634933|144597472|SUPERIORITY_OR_OTHER|||||||0.006|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 16: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.006
72534278|NCT00634933|144597472|SUPERIORITY_OR_OTHER|||||||0.021|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 16: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.021
72534279|NCT00634933|144597472|SUPERIORITY_OR_OTHER|||||||0.062|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 20: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.062
72534280|NCT00634933|144597472|SUPERIORITY_OR_OTHER|||||||0.049|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 20: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.049
72534281|NCT00634933|144597472|SUPERIORITY_OR_OTHER|||||||0.03|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 24: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.030
72534282|NCT00634933|144597472|SUPERIORITY_OR_OTHER|||||||0.005|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 24: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.005
72534283|NCT00634933|144597473|SUPERIORITY_OR_OTHER|||||||0.014|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 2: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.014
72408091|NCT01513317|144324504|SUPERIORITY_OR_OTHER||Difference in proportions|0.042||||0.494|TWO_SIDED|95.0|-0.06|0.15|||Cochran-Mantel-Haenszel||The estimated parameter is the difference in proportion of participants achieving hemoglobin improvement at Week 13.|||0.15|-0.06|0.494
72408092|NCT01513317|144324505|SUPERIORITY_OR_OTHER||Difference in proportions|0.002||||0.986|TWO_SIDED|95.0|-0.09|0.09|||Cochran-Mantel-Haenszel||The estimated parameter is the difference in proportion of participants who did not require a blood transfusion in the 8 weeks of treatment before unblinding at Week 13.|||0.09|-0.09|0.986
72534284|NCT00634933|144597473|SUPERIORITY_OR_OTHER|||||||0.025|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 2: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.025
72534285|NCT00634933|144597473|SUPERIORITY_OR_OTHER|||||||0.794|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 4: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.794
72534286|NCT00634933|144597473|SUPERIORITY_OR_OTHER|||||||0.966|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 4: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.966
72534287|NCT00634933|144597473|SUPERIORITY_OR_OTHER|||||||0.77|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 8: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.770
72534288|NCT00634933|144597473|SUPERIORITY_OR_OTHER|||||||0.456|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 8: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.456
72534289|NCT00634933|144597473|SUPERIORITY_OR_OTHER|||||||0.88|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 12: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.880
72534290|NCT00634933|144597473|SUPERIORITY_OR_OTHER|||||||0.814|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 12: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.814
72534291|NCT00634933|144597473|SUPERIORITY_OR_OTHER|||||||0.042|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 16: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.042
72534292|NCT00634933|144597473|SUPERIORITY_OR_OTHER|||||||0.035|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 16: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.035
72534293|NCT00634933|144597473|SUPERIORITY_OR_OTHER|||||||0.086|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 20: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.086
72534294|NCT00634933|144597473|SUPERIORITY_OR_OTHER|||||||0.082|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 20: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.082
72534295|NCT00634933|144597474|SUPERIORITY_OR_OTHER|||||||0.325|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 2: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.325
72572580|NCT03056157|144672768|SUPERIORITY||Slope|-16.56|||<|0.001|TWO_SIDED|95.0|-23.4|-9.72|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for PCL-5 scores for the COVID-19 cohort, t(37) = -4.77, d = 1.57.||-9.72|-23.40|<0.001
72534296|NCT00634933|144597474|SUPERIORITY_OR_OTHER|||||||0.338|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 2: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.338
72534297|NCT00634933|144597474|SUPERIORITY_OR_OTHER|||||||0.983|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 4: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.983
72534298|NCT00634933|144597474|SUPERIORITY_OR_OTHER|||||||0.296|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 4: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.296
72534299|NCT00634933|144597474|SUPERIORITY_OR_OTHER|||||||0.575|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 8: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.575
72534300|NCT00634933|144597474|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 8: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||1.000
72534301|NCT00634933|144597474|SUPERIORITY_OR_OTHER|||||||0.573|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 12: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.573
72534302|NCT00634933|144597474|SUPERIORITY_OR_OTHER|||||||0.563|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 12: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.563
72534303|NCT00634933|144597474|SUPERIORITY_OR_OTHER|||||||0.768|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 16: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.768
72534304|NCT00634933|144597474|SUPERIORITY_OR_OTHER|||||||0.977|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 16: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.977
72534305|NCT00634933|144597474|SUPERIORITY_OR_OTHER|||||||0.249|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 20: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.249
72534306|NCT00634933|144597474|SUPERIORITY_OR_OTHER|||||||0.268|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 20: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.268
72534307|NCT00634933|144597474|SUPERIORITY_OR_OTHER|||||||0.089|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 24: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.089
72534308|NCT00634933|144597474|SUPERIORITY_OR_OTHER|||||||0.079|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 24: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.079
72408093|NCT01513317|144324506|SUPERIORITY_OR_OTHER||Difference in LS means|1.96||||0.363|TWO_SIDED|95.0|-2.35|6.27|||ANCOVA||The estimated parameter is the difference in LS means for changes from baseline in bone marrow blasts at Week 13.|||6.27|-2.35|0.363
72408094|NCT01513317|144324507|SUPERIORITY_OR_OTHER||Difference in LS means|-1.69||||0.073|TWO_SIDED|95.0|-3.55|0.17|||ANCOVA||The estimated parameter is the difference in LS means of the number of RBC transfusions during the 8 weeks of treament before unblinding at Week 13.|||0.17|-3.55|0.073
72534309|NCT00634933|144597489|SUPERIORITY_OR_OTHER|||||||0.106|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 2: Good response- A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.106
72534310|NCT00634933|144597489|SUPERIORITY_OR_OTHER|||||||0.322|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 2: Good response- A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.322
72572581|NCT03056157|144672768|SUPERIORITY||Slope|-26.28||||0.002|TWO_SIDED|95.0|-42.6|-9.84|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for PCL-5 scores for the COVID-19 cohort, t(367) = -3.15, d = 0.33.||-9.84|-42.60|0.002
72534311|NCT00634933|144597489|SUPERIORITY_OR_OTHER|||||||0.059|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 4 Good response- A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.059
72534312|NCT00634933|144597489|SUPERIORITY_OR_OTHER|||||||0.25|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 4: Good response- A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.250
72534313|NCT00634933|144597489|SUPERIORITY_OR_OTHER|||||||0.255|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 8: Good response- A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.255
72626461|NCT00402987|144781766|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.3||||0.141||95.0|-5.4|0.8||Analysis of Side Effects|Generalized linear model|Treatment as a fixed effect||||0.8|-5.4|0.141
72626462|NCT00402987|144781766|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.9||||0.312||95.0|-5.7|1.8||Analysis of Side Effects|Generalized linear model|Treatment as a fixed effect||||1.8|-5.7|0.312
72534314|NCT00634933|144597489|SUPERIORITY_OR_OTHER|||||||0.105|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 8: Good response- A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.105
72534315|NCT00634933|144597489|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 12: Good response- A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.001
72534316|NCT00634933|144597489|SUPERIORITY_OR_OTHER|||||||0.019|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 12: Good response- A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.019
72534317|NCT00634933|144597489|SUPERIORITY_OR_OTHER|||||||0.011|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 16: Good response- A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.011
72534318|NCT00634933|144597489|SUPERIORITY_OR_OTHER|||||||0.113|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 16: Good response- A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.113
72534319|NCT00634933|144597489|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 20: Good response- A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.002
72534320|NCT00634933|144597489|SUPERIORITY_OR_OTHER|||||||0.006|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 20: Good response- A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.006
72626463|NCT00402987|144781766|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.7||||0.724||95.0|-4.5|3.1||Analysis of Side Effects|Generalized linear model|Treatment as a fixed effect||||3.1|-4.5|0.724
72534321|NCT00634933|144597489|SUPERIORITY_OR_OTHER|||||||0.034|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 24: Good response- A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.034
72534322|NCT00634933|144597489|SUPERIORITY_OR_OTHER|||||||0.003|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 24: Good response- A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.003
72534323|NCT01049360|144597490|SUPERIORITY_OR_OTHER||Least square mean difference|0.2|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001|TWO_SIDED|95.0|0.156|0.245||Treatment and period were fixed effects, subjects was random effect, and baseline values at each period were a covariate|Mixed Models Analysis|||||0.245|0.156|<0.0001
72534324|NCT01049360|144597490|SUPERIORITY_OR_OTHER||Least square mean difference|0.202|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001|TWO_SIDED|95.0|0.158|0.245|||Mixed Models Analysis|Treatment and period were fixed effects, subjects was random effect, and baseline values at each period were a covariate||||0.245|0.158|<0.0001
72534325|NCT01049360|144597491|SUPERIORITY_OR_OTHER||Least square mean difference|0.132|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.083|0.181|||Mixed Models Analysis|Treatment and period were fixed effects, subjects was random effect, and baseline values at each period were a covariate||||0.181|0.083|<0.0001
72534326|NCT01049360|144597491|SUPERIORITY_OR_OTHER||Least squares mean difference|0.137|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.088|0.185|||Mixed Models Analysis|Treatment and period were fixed effects, subjects was random effect, and baseline values at each period were a covariate||||0.185|0.088|<0.0001
72534327|NCT01049360|144597492|SUPERIORITY_OR_OTHER||Least squares mean difference|0.281|STANDARD_ERROR_OF_MEAN|0.026|<|0.0001|TWO_SIDED|95.0|0.23|0.333|||Mixed Models Analysis|Treatment and period were fixed effects, subjects was random effect, and baseline values at each period were a covariate||||0.333|0.230|<0.0001
72534328|NCT01049360|144597492|SUPERIORITY_OR_OTHER||Least squares mean difference|0.275|STANDARD_ERROR_OF_MEAN|0.026|<|0.0001|TWO_SIDED|95.0|0.224|0.325|||Mixed Models Analysis|Treatment and period were fixed effects, subjects was random effect, and baseline values at each period were a covariate||||0.325|0.224|<0.0001
72534329|NCT01694849|144597504|SUPERIORITY||Odds Ratio (OR)|1.092||||0.8539|TWO_SIDED|95.0|0.427|2.795||To deal with multiplicity of comparisons, a step-down approach was adopted to control the type I error to 0.05. The contrast GFT120 mg versus placebo was examined first. If not significant the GFT 80mg versus placebo contrast was not examined.|Regression, Logistic|Baseline NAS, Log transformed baseline aspartate aminotransferase and baseline plasminogen activator inhibitor 1 values|Standard error of the estimate|H\_01: OR\_80 less than or equal to 1 versus H\_11 : OR\_80 greater than 1 H\_02: OR\_120 less than or equal to 1 versus H\_12 : OR\_120 greater than 1||2.795|0.427|0.8539
72534330|NCT01694849|144597504|SUPERIORITY||Odds Ratio (OR)|0.897||||0.816|TWO_SIDED|95.0|0.361|2.232||To deal with multiplicity of comparisons, a step-down approach was adopted to control the type I error to 0.05. The contrast GFT120 mg versus placebo was examined first. If not significant the GFT 80mg versus placebo contrast was not examined.|Regression, Logistic|Baseline NAS, Log transformed baseline aspartate aminotransferase and baseline plasminogen activator inhibitor 1 values|Standard error of the estimate|H\_01: OR\_80 less than or equal to 1 versus H\_11 : OR\_80 greater than 1 H\_02: OR\_120 less than or equal to 1 versus H\_12 : OR\_120 greater than 1||2.232|0.361|0.8160
72626464|NCT00402987|144781766|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.6||||0.398||95.0|-5.4|2.1||Analysis of Side Effects|Generalized linear model|Treatment as a fixed effect||||2.1|-5.4|0.398
72626465|NCT00402987|144781766|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.4||||0.846||95.0|-4.1|3.4||Analysis of Side Effects|Generalized linear model|Treatment as a fixed effect||||3.4|-4.1|0.846
72626466|NCT00402987|144781766|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.3||||0.572||95.0|-5.6|3.1||Analysis of Side Effects|Generalized linear model|Treatment as a fixed effect||||3.1|-5.6|0.572
72534331|NCT01694849|144597505|SUPERIORITY||difference in least square mean change|-0.27||||0.225|TWO_SIDED|95.0|-0.75|0.2|||Mixed Models Analysis|Baseline Non-Alcoholic Fatty Liver Disease Activity Score|Standard error of the least squares mean|"H0: difference in least squares (LS) mean change from baseline equal to 0 H1: difference in LS mean change from baseline not equal to 0~Population with baseline Non-Alcoholic Fatty Liver Disease Activity Score greater than or equal to 4"||0.2|-0.75|0.225
72534332|NCT01694849|144597505|SUPERIORITY||Difference in least square mean change|-0.28||||0.254|TWO_SIDED|95.0|-0.76|0.2|||Mixed Models Analysis|Baseline Non-Alcoholic Fatty Liver Disease Activity Score|Standard error of the least squares mean|"H0: difference in least squares (LS) mean change from baseline equal to 0 H1: difference in LS mean change from baseline not equal to 0~Population with baseline Non-Alcoholic Fatty Liver Disease Activity Score greater than or equal to 4"||0.2|-0.76|0.254
72534333|NCT01694849|144597506|SUPERIORITY||Odds Ratio (OR)|1.073||||0.8586|TWO_SIDED|95.0|0.493|2.339|||Regression, Logistic|Baseline Non-Alcoholic Fatty Liver Disease Activity Score.|Standard error of the estimate|Population with baseline Non-Alcoholic Fatty Liver Disease Activity Score greater than or equal to 4||2.339|0.493|0.8586
72534334|NCT01694849|144597506|SUPERIORITY||Odds Ratio (OR)|1.601||||0.2265|TWO_SIDED|95.0|0.747|3.432|||Regression, Logistic|Baseline Non-Alcoholic Fatty Liver Disease Activity Score|Standard error of the estimate|Population with baseline Non-Alcoholic Fatty Liver Disease Activity Score greater than or equal to 4||3.432|0.747|0.2265
72534335|NCT01694849|144597507|SUPERIORITY||Odds Ratio (OR)|0.723||||0.5231|TWO_SIDED|95.0|0.267|1.958|||Regression, Logistic|Baseline value of the analyzed parameter|Standard error of the estimate|Population with baseline Non-Alcoholic Fatty Liver Disease Activity Score greater than or equal to 4||1.958|0.267|0.5231
72534336|NCT01694849|144597507|SUPERIORITY||Odds Ratio (OR)|1.102||||0.8459|TWO_SIDED|95.0|0.415|2.924|||Regression, Logistic|Baseline value of the analyzed parameter|Standard error of the estimate|Population with baseline Non-Alcoholic Fatty Liver Disease Activity Score greater than or equal to 4||2.924|0.415|0.8459
72534337|NCT01694849|144597508|SUPERIORITY||Odds Ratio (OR)|0.638||||0.5229|TWO_SIDED|95.0|0.161|2.529|||Regression, Logistic|Baseline value of the analyzed parameter|Standard error of the estimate|Population with baseline Non-Alcoholic Fatty Liver Disease Activity Score greater than or equal to 4||2.529|0.161|0.5229
72534338|NCT01694849|144597508|SUPERIORITY||Odds Ratio (OR)|1.433||||0.5646|TWO_SIDED|95.0|0.421|4.875|||Regression, Logistic|Baseline value of the analyzed parameter|Standard error of the estimate|Population with baseline Non-Alcoholic Fatty Liver Disease Activity Score greater than or equal to 4||4.875|.421|0.5646
72534339|NCT01694849|144597509|SUPERIORITY||Odds Ratio (OR)|0.382||||0.1983|TWO_SIDED|95.0|0.088|1.656|||Regression, Logistic|Baseline value of the analyzed parameter|Standard error of the estimate|Population with baseline Non-Alcoholic Fatty Liver Disease Activity Score greater than or equal to 4||1.656|0.088|0.1983
72534340|NCT01694849|144597509|SUPERIORITY||Odds Ratio (OR)|1.0||||1|TWO_SIDED|95.0|0.288|3.466|||Regression, Logistic|Baseline value of the analyzed parameter|Standard error of the estimate|Population with baseline Non-Alcoholic Fatty Liver Disease Activity Score greater than or equal to 4||3.466|0.288|1.0000
72534341|NCT01694849|144597510|SUPERIORITY||Odds Ratio (OR)|0.653||||0.3543|TWO_SIDED|95.0|0.265|1.609|||Regression, Logistic|Baseline value of the analyzed parameter|Standard error of the estimate|Population with baseline Non-Alcoholic Fatty Liver Disease Activity Score greater than or equal to 4||1.609|0.265|0.3543
72534342|NCT01694849|144597510|SUPERIORITY||Odds Ratio (OR)|1.27||||0.578|TWO_SIDED|95.0|0.547|2.953|||Regression, Logistic|Baseline value of the analyzed parameter|Standard error of the estimate|Population with baseline Non-Alcoholic Fatty Liver Disease Activity Score greater than or equal to 4||2.953|0.547|0.5780
72572582|NCT03056157|144672768|SUPERIORITY||Slope|-18.72||||0.01|TWO_SIDED|95.0|-32.4|-4.92|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for PCL-5 scores for the COVID-19 cohort, t(37) = -2.67, d = 0.28.||-4.92|-32.40|0.01
72572583|NCT03056157|144672768|SUPERIORITY||Slope|-5.25||||0.04|TWO_SIDED|95.0|-10.21|-0.29|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for B- IPF scores, the Pre-Post PCT Time slope was -5.25 \[95% CI = -10.21, -0.29\], p-value = 0.04, t(116) = -2.08, d = 0.39.||-0.29|-10.21|0.04
72534343|NCT01694849|144597511|SUPERIORITY||Difference in least square mean change|1.24||||0.711|TWO_SIDED|95.0|-5.33|7.81|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|Change in aspartate transaminase (U/L)||7.81|-5.33|0.711
72534344|NCT01694849|144597511|SUPERIORITY||Difference in least square mean change|-0.94||||0.78|TWO_SIDED|95.0|-7.58|5.7|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|Change in aspartate transaminase (U/L)||5.7|-7.58|0.78
72534345|NCT01694849|144597511|SUPERIORITY||Difference in least square mean change|-6.13||||0.221|TWO_SIDED|95.0|-15.97|3.71|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|Change in alanine aminotransferase (U/L)||3.71|-15.97|0.221
72534346|NCT01694849|144597511|SUPERIORITY||Difference in least square mean change|-9.45||||0.062|TWO_SIDED|95.0|-19.4|0.49|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|Change in alanine aminotransferase (U/L)||0.49|-19.4|0.062
72534347|NCT01694849|144597511|SUPERIORITY||Difference in least square mean change|-23.02|||<|0.001|TWO_SIDED|95.0|-27.16|-18.88|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|Change in Alkaline phosphatases (U/L)||-18.88|-27.16|<0.001
72534348|NCT01694849|144597511|SUPERIORITY||Difference in least square mean change|-23.85|||<|0.001|TWO_SIDED|95.0|-28.04|2.12|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|Change in Alkaline phosphatases (U/L)||2.12|-28.04|<0.001
72534349|NCT01694849|144597511|SUPERIORITY||Difference in least square mean change|-31.41|||<|0.001|TWO_SIDED|95.0|-43.78|-19.05|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|Change in Gamma-glutamyl transferase (U/L)||-19.05|-43.78|<0.001
72534350|NCT01694849|144597511|SUPERIORITY||Difference in least square mean change|-29.31|||<|0.001|TWO_SIDED|95.0|-41.84|-16.77|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|Change in Gamma-glutamyl transferase (U/L)||-16.77|-41.84|<0.001
72534351|NCT01694849|144597512|SUPERIORITY||Difference in least square mean change|0.14|||<|0.001|TWO_SIDED|95.0|0.06|0.21|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||0.21|0.06|<0.001
72534352|NCT01694849|144597512|SUPERIORITY||Difference in least square mean change|0.19|||<|0.001|TWO_SIDED|95.0|0.11|0.26|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||0.26|0.11|<0.001
72534353|NCT01694849|144597513|SUPERIORITY||Difference in least square mean change|141.78||||0.095|TWO_SIDED|95.0|-24.99|308.55|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||308.55|-24.99|0.095
72534354|NCT01694849|144597513|SUPERIORITY||Difference in least square mean change|-70.57||||0.412|TWO_SIDED|95.0|-239.85|98.71||Baseline parameter value and presence of diabetes as random factors|Mixed Models Analysis||Standard error of the least square mean|||98.71|-239.85|0.412
72534355|NCT01694849|144597514|SUPERIORITY||Difference in least square mean change|32.39||||0.592|TWO_SIDED|95.0|-86.63|151.42|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||151.42|-86.63|0.592
72534356|NCT01694849|144597514|SUPERIORITY||Difference in least square mean change|31.35||||0.61|TWO_SIDED|95.0|-89.42|152.12|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||152.12|-89.42|0.61
72534357|NCT01694849|144597515|SUPERIORITY||Difference in least square mean change|1.67||||0.459|TWO_SIDED|95.0|-2.77|6.11|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||6.11|-2.77|0.459
72534358|NCT01694849|144597515|SUPERIORITY||Difference in least square mean change|-0.67||||0.764|TWO_SIDED|95.0|-5.06|3.72|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||3.72|-5.06|0.764
72534359|NCT01694849|144597516|SUPERIORITY||Difference in least square mean change|-12.92||||0.466|TWO_SIDED|95.0|-47.79|21.95|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||21.95|-47.79|0.466
72534360|NCT01694849|144597516|SUPERIORITY||Difference in least square mean change|-5.82||||0.745|TWO_SIDED|95.0|-41.07|29.42|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||29.42|-41.07|0.745
72534361|NCT01694849|144597517|SUPERIORITY||Difference in least square mean change|-26.57||||0.018|TWO_SIDED|95.0|-48.59|-4.54|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|FG19||-4.54|-48.59|0.018
72534362|NCT01694849|144597517|SUPERIORITY||Difference in least square mean change|-40.39|||<|0.001|TWO_SIDED|95.0|-62.61|-18.17|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|FG19||-18.17|-62.61|<0.001
72534363|NCT01694849|144597517|SUPERIORITY||Difference in least square mean change|190.07||||0.101|TWO_SIDED|95.0|-37.38|417.52|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|FG21||417.52|-37.38|0.101
72534364|NCT01694849|144597517|SUPERIORITY||Difference in least square mean change|228.33||||0.052|TWO_SIDED|95.0|-2.16|458.82|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|FG21||458.82|-2.16|0.052
72534365|NCT01694849|144597518|SUPERIORITY||Difference in least square mean change|-0.14||||0.002|TWO_SIDED|95.0|-0.29|-0.01|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||-0.01|-0.29|0.002
72534366|NCT01694849|144597518|SUPERIORITY||Difference in least square mean change|-0.24|||<|0.001|TWO_SIDED|95.0|-0.34|-0.15|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||-0.15|-0.34|<0.001
72534367|NCT01694849|144597519|SUPERIORITY||Difference in least square mean change|-16.54||||0.203|TWO_SIDED|95.0|-42.07|8.98|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|Hyaluronic acid||8.98|-42.07|0.203
72408095|NCT01221441|144324534|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||Mixed Models Analysis|Denominator degrees of freedom were adjusted using the Kenward-Roger's method.||"The primary efficacy evaluation based on IKDC and the VAS were tested at week 52 evaluated 100 mm VAS with the following superiority hypothesis:~HO: μTG = μPC vs. HA: μTG ≠ μPC, where μTG and μPC are the mean change from baseline in IKDC or VAS scores at week 52 for patients in the TG-C and placebo control groups, respectively. If the null hypotheses for both the IKDC and the VAS are rejected, it the clinical effect of TG-C is concluded to be superior to that of the control."||||<0.01
72408096|NCT01221441|144324535|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||Mixed Models Analysis|Denominator degrees of freedom were adjusted using the Kenward-Roger's method.||"The primary efficacy evaluation based on IKDC and the VAS were tested at week 52 evaluated 100 mm VAS with the following superiority hypothesis:~HO: μTG = μPC vs. HA: μTG ≠ μPC, where μTG and μPC are the mean change from baseline in IKDC or VAS scores at week 52 for patients in the TG-C and placebo control groups, respectively. If the null hypotheses for both the IKDC and the VAS are rejected, it the clinical effect of TG-C is concluded to be superior to that of the control."||||<0.01
72408097|NCT01221441|144324536|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||Mixed Models Analysis|Denominator degrees of freedom were adjusted using the Kenward-Roger's method.||"The efficacy evaluation at week 104 evaluated KOOS with the following superiority hypothesis:~HO: μTG = μPC vs. HA: μTG ≠ μPC, where μTG and μPC are the mean change from baseline in KOOS scores at week 104 for patients in the TG-C and placebo control groups, respectively. If the null hypotheses for KOOS is rejected, it the clinical effect of TG-C is concluded to be superior to that of the control."||||<0.01
72408098|NCT01221441|144324537|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||Mixed Models Analysis|Denominator degrees of freedom were adjusted using the Kenward-Roger's method.||"The efficacy evaluation at week 104 evaluated Lysholm score with the following superiority hypothesis:~HO: μTG = μPC vs. HA: μTG ≠ μPC, where μTG and μPC are the mean change from baseline in KOOS scores at week 104 for patients in the TG-C and placebo control groups, respectively. If the null hypotheses for Lysholm score is rejected, it the clinical effect of TG-C is concluded to be superior to that of the control."||||<0.01
72408099|NCT00739336|144324556|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||Mixed Models Analysis|||Piecewise linear multilevel models with multiple observations nested within each participant were used. Random components (intercept, slope) were introduced into the model to account for dependence among measurements within a participant and assessed by nested model comparisons using the deviance statistic (difference in -2LL).||||<0.01
72408100|NCT00120042|144324581|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||Chi-squared|||We planned that up to 300 women would be recruited. This sample size would achieve 80% poer at a 5% significance level to detect a reduction from 40% placental retention rate with no specific therapy (Group 1) to 20% with Group 2 or 3. An interim analysis was planned after 240 women had been recruited.||||0.05
72408101|NCT00120042|144324582|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||t-test, 2 sided|||||||<0.05
72408102|NCT00436280|144324609|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.512|||||TWO_SIDED|95.0|0.217|1.206|||||Comparing GCB versus non-GCB|Comparing GCB versus non-GCB||1.206|0.217|
72534368|NCT01694849|144597519|SUPERIORITY||Difference in least square mean change|-6.79||||0.603|TWO_SIDED|95.0|-32.49|18.9|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||18.9|-32.49|0.603
72534369|NCT01694849|144597519|SUPERIORITY||Difference in least square mean change|-0.73||||0.235|TWO_SIDED|95.0|-1.95|0.48|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|PIIINP||0.48|-1.95|0.235
72408103|NCT00436280|144324610|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.878|||||TWO_SIDED|95.0|0.388|1.989|||||Comparing High Expression versus Low Expression|Comparing High Expression versus Low Expression||1.989|0.388|
72408104|NCT01049919|144324617|SUPERIORITY||Hazard Ratio (HR)|0.64||||0.224|TWO_SIDED|95.0|0.31|1.31|||Proportional Hazards Regression|||||1.31|0.31|0.224
72408105|NCT01049919|144324618|SUPERIORITY|||||||0.671||||||Treatment-by-week p-value is reported.|Repeated measures model|The statistical analysis model includes treatment group, week, treatment-by-week, and baseline pain measurement.||||||0.671
72408106|NCT01049919|144324619|SUPERIORITY|||||||0.714||||||Treatment-by-week p-value is reported.|Repeated measures model|The statistical analysis model includes treatment group, week, treatment-by-week, and baseline pain measurement.||||||0.714
72408107|NCT01049919|144324621|SUPERIORITY||Hazard Ratio (HR)|0.37||||0.018|TWO_SIDED|95.0|0.16|0.85|||Proportional Hazards Regression|||||0.85|0.16|0.018
72408108|NCT01663259|144324628|OTHER||||||||||||||||||Estimates of proportion event-free at 1 and 2 years calculated using Kaplan-Meier methods, and the 2-sided, 95% confidence intervals were calculated by the Greenwood method. All analyses were performed using SAS v9.4 software and R version 3.5.2.|||
72408109|NCT01663259|144324629|OTHER||||||||||||||||||Survival proportion estimates at 1 and 2 years were calculated using Kaplan-Meier methods, and the 2-sided, 95% confidence intervals calculated by the Greenwood method. All analyses were performed using SAS v9.4 software and R version 3.5.2.|||
72408110|NCT01663259|144324630|OTHER||||||||||||||||||Estimates of proportion LRP event-free at 1 and 2 years were calculated using Kaplan-Meier methods, and the 2-sided, 95% confidence intervals calculated by the Greenwood method. All analyses were performed using SAS v9.4 software and R version 3.5.2.|||
72408111|NCT01532687|144324641|SUPERIORITY|Log-log plots revealed crossing of the curves at late time points, indicating a possible interaction between treatment arms over time. We used the Gehan-Wilcoxon test, which weights early differences between groups, to test whether there is a difference between the treatment arms early in the study.||||||0.017|||||||Gehan-Wilcoxon|||Statistical results are for the full randomized population (n = 54). The study was originally designed with overall one-sided alpha of 5%, where a total of 73 patients (36 in the gemcitabine + placebo arm, and 37 in the gemcitabine + pazopanib arm) were required to achieve 80% power to detect a 2.5 month increase in median PFS (a hazard ratio of 0.55) between the two treatment arms. Study was closed early by the sponsor due to slow accrual and funds and thus was under powered.||||0.017
72408112|NCT01532687|144324641|OTHER|Log-log plots revealed crossing of the curves at late time points, indicating a possible interaction between treatment arms over time. We used the Gehan-Wilcoxon test, which weights early differences between groups, to test whether there is a difference between the treatment arms early in the study.||||||0.195|||||||Gehan-Wilcoxon|||Comparison between the two arms for the liposarcoma subgroup||||0.195
72572584|NCT03056157|144672769|SUPERIORITY||Slope|-6.38||||0.1|TWO_SIDED|95.0|-13.97|1.22|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for CAPS-5 scores for the COVID-19 cohort, t(49) = -1.69, d = 0.48.||1.22|-13.97|0.10
72572585|NCT03056157|144672769|SUPERIORITY||Slope|-13.29|||<|0.001|TWO_SIDED|95.0|-18.96|-7.62|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for CAPS-5 scores for the COVID-19 cohort, t(32) = -4.71, d = 1.67.||-7.62|-18.96|<0.001
72572586|NCT03056157|144672769|SUPERIORITY||Slope|-6.92||||0.001|TWO_SIDED|95.0|-11.96|-1.87|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for CAPS-5 scores for the COVID-19 cohort, t(32) = -2.75, d = 0.97.||-1.87|-11.96|0.001
72408113|NCT01532687|144324641|OTHER|Log-log plots revealed crossing of the curves at late time points, indicating a possible interaction between treatment arms over time. We used the Gehan-Wilcoxon test, which weights early differences between groups, to test whether there is a difference between the treatment arms early in the study.||||||0.079|||||||Gehan-Wilcoxon|||Statistical results are for the 'other' sarcoma subgroup (n = 38)||||0.079
72408114|NCT01532687|144324643|SUPERIORITY|Analysis was not powered for secondary endpoints. Given the study closed early due to slow enrollment, we do not anticipate detecting a statistical difference between the two groups||||||0.5||||||Yate's continuity correction was applied because of the number of subjects and successes (n = 4)|One-sided Proportions Test|||Statistical results are for the full randomized population (n = 54). The study tests whether gemcitabine plus pazopanib is superior to gemcitabine plus placebo (one-sided proportion test with Yate's continuity correction)||||0.5
72534370|NCT01694849|144597519|SUPERIORITY||Difference in least square mean change|-0.81||||0.193|TWO_SIDED|95.0|-2.04|0.41|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|PIIINP||0.41|-2.04|0.193
72572587|NCT03056157|144672769|SUPERIORITY||Slope|5.22||||0.34|TWO_SIDED|95.0|-5.6|16.05|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for CAPS-5 scores for the COVID-19 cohort, t(49) = 0.97, d = 0.28.||16.05|-5.60|0.34
72572588|NCT03056157|144672769|SUPERIORITY||Slope|5.93||||0.17|TWO_SIDED|95.0|-2.55|14.41|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for CAPS-5 scores for the COVID-19 cohort, t(49) = 1.40, d = 0.40.||14.41|-2.55|0.17
72626467|NCT00402987|144781766|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.8||||0.014||95.0|1.2|10.4||Analysis of Convenience|Generalized linear model|Treatment as a fixed effect||||10.4|1.2|0.014
72626468|NCT00402987|144781766|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.6||||0.573||95.0|-4.0|7.2||Analysis of Convenience|Generalized linear model|Treatment as a fixed effect||||7.2|-4.0|0.573
72408115|NCT01532687|144324643|SUPERIORITY|||||||0.3||||||Yate's continuity correction was applied because of small number of participants (n = 16) and successes (n = 2).|One-sided Proportion Test|||Statistical results are for the Liposarcoma group (n = 16). The study tests whether gemcitabine plus pazopanib is superior to gemcitabine plus placebo (one-sided proportion test with Yate's continuity correction). Analysis was not powered for the secondary endpoints. Given the study closed early due to slow enrollment we do not anticipate detecting a statistical difference between the groups.||||0.3
72534371|NCT01694849|144597519|SUPERIORITY||Difference in least square mean change|6.21||||0.348|TWO_SIDED|95.0|-6.81|19.22|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|TIMP-1||19.22|-6.81|0.348
72534372|NCT01694849|144597519|SUPERIORITY||Difference in least square mean change|-14.66||||0.029|TWO_SIDED|95.0|-27.81|1.51|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|TIMP-1||1.51|-27.81|0.029
72534373|NCT01694849|144597520|SUPERIORITY||Difference in least square mean change|-0.05|||<|0.001|TWO_SIDED|95.0|-0.07|-0.02|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||-0.02|-0.07|<0.001
72534374|NCT01694849|144597520|SUPERIORITY||Difference in least square mean change|-0.05|||<|0.001|TWO_SIDED|95.0|-0.08|-0.02|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||-0.02|-0.08|<0.001
72534375|NCT01694849|144597521|SUPERIORITY||Difference in least square mean change|-0.11|||<|0.001|TWO_SIDED|95.0|-0.15|-0.07|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||-0.07|-0.15|<0.001
72534376|NCT01694849|144597521|SUPERIORITY||Difference in least square mean change|-0.11|||<|0.001|TWO_SIDED|95.0|-0.15|-0.07|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||-0.07|-0.15|<0.001
72534377|NCT01694849|144597522|SUPERIORITY||Difference in least square mean change|0.06||||0.471|TWO_SIDED|95.0|-0.11|0.23|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||0.23|-0.11|0.471
72572589|NCT03056157|144672769|SUPERIORITY||Slope|0.7||||0.83|TWO_SIDED|95.0|-6.04|7.44|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for CAPS-5 scores for the COVID-19 cohort, t(49) = 0.21, d = 0.06.||7.44|-6.04|0.83
72572590|NCT03056157|144672770|SUPERIORITY||Slope|0.6||||0.76|TWO_SIDED|95.0|-3.12|4.2|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for PHQ-9 scores for the COVID-19 cohort, t(373) = 0.30, d = 0.03.||4.20|-3.12|0.76
72572591|NCT03056157|144672770|SUPERIORITY||Slope|-3.12||||0.002|TWO_SIDED|95.0|-6.96|-1.56|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for PHQ-9 scores for the COVID-19 cohort, t(37) = -3.14, d = 1.03.||-1.56|-6.96|0.002
72572592|NCT03056157|144672770|SUPERIORITY||Slope|-4.92|||<|0.001|TWO_SIDED|95.0|-7.32|-2.4|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for PHQ-9 scores for the COVID-19 cohort, t(37) = -3.88, d = 1.27.||-2.40|-7.32|<0.001
72572593|NCT03056157|144672770|SUPERIORITY||Slope|-4.8||||0.13|TWO_SIDED|95.0|-11.16|1.44|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for PHQ-9 scores for the COVID-19 cohort, t(373) = -1.50, d = 0.16.||1.44|-11.16|0.13
72572594|NCT03056157|144672770|SUPERIORITY||Slope|-2.4||||0.38|TWO_SIDED|95.0|-7.68|3.0|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for PHQ-9 scores for the COVID-19 cohort, t(373) = -0.87, d = 0.09.||3.00|-7.68|0.38
72572595|NCT03056157|144672770|SUPERIORITY||Slope|2.4||||0.26|TWO_SIDED|95.0|-0.96|5.88|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for PHQ-9 scores for the COVID-19 cohort, t(373) = 1.42, d = 0.15.||5.88|-0.96|0.26
72572596|NCT03056157|144672771|SUPERIORITY||Slope|-6.65|||<|0.001|TWO_SIDED|95.0|-10.23|-3.07|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for CAPS-5 scores, t(348) = -3.65, d = 0.39.||-3.07|-10.23|<0.001
72572597|NCT03056157|144672771|SUPERIORITY||Slope|-11.88|||<|0.001|TWO_SIDED|95.0|-14.43|-9.32|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for CAPS-5 scores, t(131) = -9.14, d = 1.60.||-9.32|-14.43|<0.001
72572598|NCT03056157|144672771|SUPERIORITY||Slope|-5.23|||<|0.001|TWO_SIDED|95.0|-7.74|-2.72|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for CAPS-5 scores, t(131) = -4.10, d = 0.72.||-2.72|-7.74|<0.001
72626469|NCT00402987|144781766|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.0||||0.482||95.0|-7.7|3.6||Analysis of Convenience|Generalized linear model|Treatment as a fixed effect||||3.6|-7.7|0.482
72626470|NCT00402987|144781766|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|7.8||||0.007||95.0|2.2|13.5||Analysis of Convenience|Generalized linear model|Treatment as a fixed effect||||13.5|2.2|0.007
72626471|NCT00402987|144781766|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.2||||0.143||95.0|-1.4|9.8||Analysis of Convenience|Generalized linear model|Treatment as a fixed effect||||9.8|-1.4|0.143
72534378|NCT01694849|144597522|SUPERIORITY||Difference in least square mean change|-0.25||||0.005|TWO_SIDED|95.0|-0.42|-0.08|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||-0.08|-0.42|0.005
72534379|NCT01694849|144597523|SUPERIORITY||Difference in least square mean change|-0.07||||0.457|TWO_SIDED|95.0|-0.27|0.12|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||0.12|-0.27|0.457
72534380|NCT01694849|144597523|SUPERIORITY||Difference in least square mean|-0.08||||0.428|TWO_SIDED|95.0|-0.28|0.12|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||0.12|-0.28|0.428
72534381|NCT01694849|144597524|SUPERIORITY||Difference in least square mean change|-9.22|||<|0.001|TWO_SIDED|95.0|-13.19|-5.24|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||-5.24|-13.19|<0.001
72534382|NCT01694849|144597524|SUPERIORITY||Difference in least square mean change|-9.08|||<|0.001|TWO_SIDED|95.0|-13.12|-5.04|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||-5.04|-13.12|<0.001
72534383|NCT01694849|144597525|SUPERIORITY||Difference in least square mean change|0.02||||0.531|TWO_SIDED|95.0|-0.05|0.09|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||0.09|-0.05|0.531
72534384|NCT01694849|144597525|SUPERIORITY||Difference in least square mean change|-0.02||||0.638|TWO_SIDED|95.0|-0.08|0.05|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||0.05|-0.08|0.638
72534385|NCT01694849|144597526|SUPERIORITY||Difference in least square mean change|-0.14||||0.831|TWO_SIDED|95.0|-1.39|1.12|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|Total bilirubin||1.12|-1.39|0.831
72534386|NCT01694849|144597526|SUPERIORITY||Difference in least square mean change|0.2||||0.754|TWO_SIDED|95.0|-1.07|1.47|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|Total bilirubin||1.47|-1.07|0.754
72534387|NCT01694849|144597526|SUPERIORITY||Difference in least square mean change|-0.03||||0.848|TWO_SIDED|95.0|-0.36|0.3|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|Conjugated Bilirubin||0.3|-0.36|0.848
72534388|NCT01694849|144597526|SUPERIORITY||Difference in least square mean change|0.11||||0.511|TWO_SIDED|95.0|-0.22|0.45|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|Conjugated Bilirubin||0.45|-0.22|0.511
72534389|NCT01694849|144597527|SUPERIORITY||Difference in least square mean change|-2.83||||0.075|TWO_SIDED|95.0|-5.95|0.29|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||0.29|-5.95|0.075
72534390|NCT01694849|144597527|SUPERIORITY||Difference in least square mean change|-1.11||||0.491|TWO_SIDED|95.0|-4.29|2.07|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||2.07|-4.29|0.491
72534391|NCT01694849|144597528|SUPERIORITY||Difference in least square mean change|-0.03||||0.393|TWO_SIDED|95.0|-0.1|0.04|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||0.04|-0.1|0.393
72534392|NCT01694849|144597528|SUPERIORITY||Difference in least square mean change|-0.04||||0.289|TWO_SIDED|95.0|-0.11|0.03|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||0.03|-0.11|0.289
72572599|NCT03056157|144672771|SUPERIORITY||Slope|1.36||||0.39|TWO_SIDED|95.0|-1.73|4.45|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for CAPS-5 scores, t(348) = 0.87, d = 0.09.||4.45|-1.73|0.39
72572600|NCT03056157|144672771|SUPERIORITY||Slope|0.08||||0.94|TWO_SIDED|95.0|-2.1|2.26|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for CAPS-5 scores, t(348) = 0.07, d = 0.001.||2.26|-2.10|0.94
72572601|NCT03056157|144672771|SUPERIORITY||Slope|-1.28||||0.25|TWO_SIDED|95.0|-3.48|0.91|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for CAPS-5 scores, t(348) = -1.15, d = 0.12.||0.91|-3.48|0.25
72572602|NCT03056157|144672772|SUPERIORITY||Odds Ratio (OR)|6.44||||0.01|TWO_SIDED|95.0|1.29|63.18|||Fisher Exact|||Odds ratio comparison of the proportions of participants who experienced probable recovery in CAPS-5 from baseline to post-treatment in AD-MIL versus PCT.||63.18|1.29|0.01
72572603|NCT03056157|144672772|SUPERIORITY||Odds Ratio (OR)|1.51||||0.4|TWO_SIDED|95.0|0.61|3.75|||Fisher Exact|||Odds ratio comparison of the proportions of participants who experienced improvement in CAPS-5 from baseline to post-treatment in AD-MIL versus PCT.||3.75|0.61|0.40
72626472|NCT00402987|144781766|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.6||||0.273||95.0|-2.9|10.2||Analysis of Convenience|Generalized linear model|Treatment as a fixed effect||||10.2|-2.9|0.273
72626473|NCT00402987|144781766|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|13.0||||0.003||95.0|4.4|21.6||Analysis of Global Satisfaction|Generalized linear model|Treatment as a fixed effect||||21.6|4.4|0.003
72626474|NCT00402987|144781766|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|11.7||||0.029||95.0|1.2|22.2||Analysis of Global Satisfaction|Generalized linear model|Treatment as a fixed effect||||22.2|1.2|0.029
72626475|NCT00402987|144781766|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|6.2||||0.251||95.0|-4.4|16.8||Analysis of Global Satisfaction|Generalized linear model|Treatment as a fixed effect||||16.8|-4.4|0.251
72626476|NCT00402987|144781766|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|6.8||||0.204||95.0|-3.7|17.4||Analysis of Global Satisfaction|Generalized linear model|Treatment as a fixed effect||||17.4|-3.7|0.204
72408116|NCT01532687|144324643|SUPERIORITY|||||||0.8||||||Yate's continuity correction was applied because of the small number of participants and successes (n = 2).|One-sided Proportion Test|||Statistical results are for the Other Sarcoma group (n = 38). The study tests whether gemcitabine plus pazopanib is superior to gemcitabine plus placebo (one-sided proportion test with Yate's continuity correction). Analysis was not powered for secondary endpoints. Given the study closed early due to slow enrollment, we do not anticipate detecting a statistical difference between the two groups.||||0.8
72626477|NCT00402987|144781766|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.3||||0.808||95.0|-9.2|11.8||Analysis of Global Satisfaction|Generalized linear model|Treatment as a fixed effect||||11.8|-9.2|0.808
72534393|NCT01694849|144597529|SUPERIORITY||Difference in least square mean change|-0.47|||<|0.001|TWO_SIDED|95.0|-0.73|-0.21|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|Triglycerides||-0.21|-0.73|<0.001
72534394|NCT01694849|144597529|SUPERIORITY||Difference in least square mean change|-0.55|||<|0.001|TWO_SIDED|95.0|-0.81|-0.29|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|Triglycerides||-0.29|-0.81|<0.001
72534395|NCT01694849|144597529|SUPERIORITY||Difference in least square mean change|-0.35||||0.001|TWO_SIDED|95.0|-0.56|-0.14|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|Cholesterol||-0.14|-0.56|0.001
72534396|NCT01694849|144597529|SUPERIORITY||Difference in least square mean change|-0.43|||<|0.001|TWO_SIDED|95.0|-0.64|-0.23|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|Cholesterol||-0.23|-0.64|<0.001
72534397|NCT01694849|144597529|SUPERIORITY||Difference in least square mean change|-0.46|||<|0.001|TWO_SIDED|95.0|-0.67|-0.24|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|Non-high Density Lipoproteins Cholesterol||-0.24|-0.67|<0.001
72534398|NCT01694849|144597529|SUPERIORITY||Difference in least square mean change|-0.54|||<|0.001|TWO_SIDED|95.0|-0.75|-0.32|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|Non-high Density Lipoproteins Cholesterol||-0.32|-0.75|<0.001
72534399|NCT01694849|144597529|SUPERIORITY||Difference in least square mean change|0.09||||0.005|TWO_SIDED|95.0|0.03|0.15|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|High Density Lipoproteins Cholesterol||0.15|0.03|0.005
72534400|NCT01694849|144597529|SUPERIORITY||Difference in least square mean change|0.11|||<|0.001|TWO_SIDED|95.0|0.05|0.17|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|High Density Lipoproteins Cholesterol||0.17|0.05|<0.001
72534401|NCT01694849|144597529|SUPERIORITY||Difference in least square mean change|-0.18|||<|0.001|TWO_SIDED|95.0|-0.26|-0.11|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|Very Low Density Lipoproteins Cholesterol||-0.11|-0.26|<0.001
72534402|NCT01694849|144597529|SUPERIORITY||Difference in least square mean change|-0.17|||<|0.001|TWO_SIDED|95.0|-0.25|-0.09|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|Very Low Density Lipoproteins Cholesterol||-0.09|-0.25|<0.001
72534403|NCT01694849|144597529|SUPERIORITY||Difference in least square mean change|-0.2||||0.031|TWO_SIDED|95.0|-0.38|-0.02|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|Low Density Lipoproteins Cholesterol||-0.02|-0.38|0.031
72534404|NCT01694849|144597529|SUPERIORITY||Difference in least square mean change|-0.24||||0.009|TWO_SIDED|95.0|-0.42|-0.06|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|Low Density Lipoproteins Cholesterol||-0.06|-0.42|0.009
72534405|NCT01694849|144597530|SUPERIORITY||Difference in least square mean change|5.73||||0.038|TWO_SIDED|95.0|0.31|11.14|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|Apo A1||11.14|0.31|0.038
72534406|NCT01694849|144597530|SUPERIORITY||Difference in least square mean change|7.07||||0.012|TWO_SIDED|95.0|1.59|12.55|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|Apo A1||12.55|1.59|0.012
72534407|NCT01694849|144597530|SUPERIORITY||Difference in least square mean change|-12.41|||<|0.001|TWO_SIDED|95.0|-17.56|-7.25|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|Apo B||-7.25|-17.56|<0.001
72534408|NCT01694849|144597530|SUPERIORITY||Difference in least square mean change|-9.61|||<|0.001|TWO_SIDED|95.0|-14.81|-4.41|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|Apo B||-4.41|-14.81|<0.001
72626478|NCT00402987|144781766|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.5||||0.371||95.0|-6.6|17.7||Analysis of Global Satisfaction|Generalized linear model|Treatment as a fixed effect||||17.7|-6.6|0.371
72626479|NCT00402987|144781767|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Based on life-table extension of Mantel-Haenszel method.~p-value for general association"|Mantel Haenszel|||||||<0.001
72626480|NCT00402987|144781767|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002||95.0||||"Based on life-table extension of Mantel-Haenszel method.~p-value for general association"|Mantel Haenszel|||||||0.002
72408117|NCT01532687|144324644|OTHER|Log-log plots revealed crossing of the curves at late time points, indicating a possible interaction between treatment arms over time. We used the Gehan-Wilcoxon test, which weights early differences between groups, to test whether there is a difference between the treatment arms early in the study.||||||0.481|||||||Gehan-Wilcoxon|||Overall survival estimated among all randomized participants (n = 54)||||0.481
72572604|NCT03056157|144672772|SUPERIORITY||Odds Ratio (OR)|0.78||||0.58|TWO_SIDED|95.0|0.36|1.7|||Fisher Exact|||Odds ratio comparison of the proportions of participants who experienced no change in CAPS-5 from baseline to post-treatment in AD-MIL versus PCT.||1.70|0.36|0.58
72572605|NCT03056157|144672772|SUPERIORITY||Odds Ratio (OR)|0.15||||0.06|TWO_SIDED|95.0|0.003|1.2|||Fisher Exact|||Odds ratio comparison of the proportions of participants who experienced deterioration in CAPS-5 from baseline to post-treatment in AD-MIL versus PCT.||1.20|0.003|0.06
72572606|NCT03056157|144672773|SUPERIORITY||Odds Ratio (OR)|0.49||||0.07|TWO_SIDED|95.0|0.22|1.06|||Fisher Exact|||Odds ratio comparison of the proportions of participants with a PTSD Diagnosis in CAPS-5 at post-treatment in AD-MIL versus PCT.||1.06|0.22|0.07
72572607|NCT03056157|144672773|SUPERIORITY||Odds Ratio (OR)|0.66||||0.33|TWO_SIDED|95.0|0.28|1.56|||Fisher Exact|||Odds ratio comparison of the proportions of participants with PTSD Diagnosis in CAPS-5 at 3MFU in AD-MIL versus PCT.||1.56|0.28|0.33
72572608|NCT03056157|144672773|SUPERIORITY||Odds Ratio (OR)|0.42||||0.05|TWO_SIDED|95.0|0.15|1.08|||Fisher Exact|||Odds ratio comparison of the proportions of participants with PTSD Diagnosis in CAPS-5 at 6MFU in AD-MIL versus PCT.||1.08|0.15|0.05
72408118|NCT01532687|144324644|OTHER|Log-log plots revealed crossing of the curves at late time points, indicating a possible interaction between treatment arms over time. We used the Gehan-Wilcoxon test, which weights early differences between groups, to test whether there is a difference between the treatment arms early in the study.||||||0.353|||||||Gehan-Wilcoxon|||Overall survival compared between the two arms for the liposarcoma subgroup (n = 16)||||0.353
72572609|NCT03056157|144672774|SUPERIORITY||Slope|-4.63||||0.003|TWO_SIDED|95.0|-7.16|-2.1|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for PCL-5 scores, t(1542) = -3.01, d = 0.13.||-2.10|-7.16|.003
72572610|NCT03056157|144672774|SUPERIORITY||Slope|-12.62|||<|0.001|TWO_SIDED|95.0|-14.43|-10.8|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for PCL-5 scores, t(161) = -11.50, d = 1.81.||-10.80|-14.43|<0.001
72572611|NCT03056157|144672774|SUPERIORITY||Slope|-7.89|||<|0.001|TWO_SIDED|95.0|-9.77|-6.2|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for PCL-5 scores, t(161) = -7.40, d = 1.16.||-6.20|-9.77|<0.001
72572612|NCT03056157|144672774|SUPERIORITY||Slope|-0.75||||0.65|TWO_SIDED|95.0|-4.01|2.52|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for PCL-5 scores, t(1542) = -0.45, d = 0.02.||2.52|-4.01|0.65
72572613|NCT03056157|144672774|SUPERIORITY||Slope|2.3||||0.05|TWO_SIDED|95.0|-0.03|4.63|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for PCL-5 scores, t(1542) = 1.94, d = 0.10.||4.63|-0.03|0.05
72572614|NCT03056157|144672774|SUPERIORITY||Slope|3.04||||0.001|TWO_SIDED|95.0|0.75|5.34|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for PCL-5 scores, t(1542) = 2.61, d = 0.13.||5.34|0.75|0.001
72572615|NCT03056157|144672775|SUPERIORITY||Odds Ratio (OR)|2.39||||0.04|TWO_SIDED|95.0|1.01|5.84|||Fisher Exact|||Odds ratio comparison of the proportions of participants experiencing probable recovery in PCL-5 at post-treatment in AD-MIL versus PCT.||5.84|1.01|0.04
72408119|NCT01532687|144324644|OTHER|Log-log plots revealed crossing of the curves at late time points, indicating a possible interaction between treatment arms over time. We used the Gehan-Wilcoxon test, which weights early differences between groups, to test whether there is a difference between the treatment arms early in the study.||||||0.408|||||||Gehan-Wilcoxon|||Overall survival comparison between the two treatment arms for the other sarcoma group (n = 38)||||0.408
72572616|NCT03056157|144672775|SUPERIORITY||Odds Ratio (OR)|0.7||||0.49|TWO_SIDED|95.0|0.25|1.95|||Fisher Exact|||Odds ratio comparison of the proportions of participants experiencing improvement in PCL-5 at post-treatment in AD-MIL versus PCT.||1.95|0.25|0.49
72572617|NCT03056157|144672775|SUPERIORITY||Odds Ratio (OR)|0.58||||0.18|TWO_SIDED|95.0|0.25|1.32|||Fisher Exact|||Odds ratio comparison of the proportions of participants experiencing no change in PCL-5 at post-treatment in AD-MIL versus PCT.||1.32|0.25|0.18
72572618|NCT03056157|144672776|SUPERIORITY||Slope|-0.99||||0.14|TWO_SIDED|95.0|-2.29|0.34|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for PHQ-9 scores, t(1550) = -1.46, d = 0.07||0.34|-2.29|0.14
72572619|NCT03056157|144672776|SUPERIORITY||Slope|-5.87|||<|0.001|TWO_SIDED|95.0|-6.8|-4.9|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for PHQ-9 scores, t(161) = -12.41, d = 1.96.||-4.90|-6.80|<0.001
72572620|NCT03056157|144672776|SUPERIORITY||Slope|-4.89|||<|0.001|TWO_SIDED|95.0|-5.82|-3.94|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for PHQ-9 scores, t(161) = -10.29, d = 1.62.||-3.94|-5.82|<0.001
72572621|NCT03056157|144672776|SUPERIORITY||Slope|0.02||||0.68|TWO_SIDED|95.0|-0.99|1.53|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for PHQ-9 scores, t(1550) = 0.42, d = 0.02.||1.53|-0.99|0.68
72572622|NCT03056157|144672776|SUPERIORITY||Slope|1.36||||0.003|TWO_SIDED|95.0|0.48|2.24|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for PHQ-9 scores, t(1550) = 3.02, d = 0.15.||2.24|0.48|0.003
72572623|NCT03056157|144672776|SUPERIORITY||Slope|1.09||||0.02|TWO_SIDED|95.0|0.19|1.99|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for PHQ-9 scores, t(1550) = 2.37, d = 0.12.||1.99|0.19|0.02
72572624|NCT03056157|144672777|SUPERIORITY||Slope|-0.2||||0.18|TWO_SIDED|95.0|-0.49|0.09|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for TRGI Justification scores, t(314) = -1.35, d = 0.15.||0.09|-0.49|0.18
72572625|NCT03056157|144672777|SUPERIORITY||Slope|-0.26||||0.02|TWO_SIDED|95.0|-0.47|-0.05|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for TRGI Justification scores, t(113) = -2.44, d = 0.46.||-0.05|-0.47|0.02
72572626|NCT03056157|144672777|SUPERIORITY||Slope|-0.06||||0.62|TWO_SIDED|95.0|-0.26|0.14|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for TRGI Justification scores, t(113) = -0.69, d = 0.12.||0.14|-0.26|0.62
72572627|NCT03056157|144672777|SUPERIORITY||Slope|0.16||||0.18|TWO_SIDED|95.0|-0.07|0.39|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for TRGI Justification scores, t(314) = 1.34, d = 0.15.||0.39|-0.07|0.18
72572628|NCT03056157|144672777|SUPERIORITY||Slope|0.13||||0.14|TWO_SIDED|95.0|-0.04|0.3|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for TRGI Justification scores, t(113) = 1.49, d = 0.28.||0.30|-0.04|0.14
72572629|NCT03056157|144672777|SUPERIORITY||Slope|-0.03||||0.71|TWO_SIDED|95.0|-0.19|0.13|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for TRGI Justification scores, t(113) = -0.38, d = 0.07.||0.13|-0.19|0.71
72534409|NCT01694849|144597530|SUPERIORITY||Difference in least square mean change|3.55|||<|0.001|TWO_SIDED|95.0|2.14|4.96|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|Apo AII||4.96|2.14|<0.001
72534410|NCT01694849|144597530|SUPERIORITY||Difference in least square mean change|6.1|||<|0.001|TWO_SIDED|95.0|4.67|7.53|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|Apo AII||7.53|4.67|<0.001
72534411|NCT01694849|144597530|SUPERIORITY||Difference in least square mean change|-2.27|||<|0.001|TWO_SIDED|95.0|-3.29|-1.25|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|Apo CIII||-1.25|-3.29|<0.001
72534412|NCT01694849|144597530|SUPERIORITY||Difference in least square mean change|-1.5||||0.004|TWO_SIDED|95.0|-2.52|-0.49|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|Apo CIII||-0.49|-2.52|0.004
72534413|NCT01694849|144597530|SUPERIORITY||Difference in least square mean change|-1.78|||<|0.001|TWO_SIDED|95.0|-2.63|-0.92|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|Apo CIII/B||-0.92|-2.63|<0.001
72534414|NCT01694849|144597530|SUPERIORITY||Difference in least square mean change|-1.15||||0.009|TWO_SIDED|95.0|-2.0|-0.29|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|Apo CIII/B||-0.29|-2|0.009
72534415|NCT01694849|144597530|SUPERIORITY||Difference in least square mean change|-0.46||||0.002|TWO_SIDED|95.0|-0.75|-0.17|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|Apo CIII/nonB||-0.17|-0.75|0.002
72534416|NCT01694849|144597530|SUPERIORITY||Difference in least square mean change|-0.39||||0.008|TWO_SIDED|95.0|-0.68|-0.1|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|Apo CIII/nonB||-0.1|-0.68|0.008
72572630|NCT03056157|144672778|SUPERIORITY||Slope|-0.47|||<|0.001|TWO_SIDED|95.0|-0.74|-0.2|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for TRGI Hindsight-Bias scores, t(314) = -3.41, d = 0.39.||-0.20|-0.74|<0.001
72572631|NCT03056157|144672778|SUPERIORITY||Slope|-0.64|||<|0.001|TWO_SIDED|95.0|-0.83|-0.44|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for TRGI Hindsight-Bias scores, t(113) = -6.41, d = 1.20.||-0.44|-0.83|<0.001
72572632|NCT03056157|144672778|SUPERIORITY||Slope|-0.17||||0.07|TWO_SIDED|95.0|-0.36|0.02|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for TRGI Hindsight-Bias scores, t(113) = -1.83, d = 0.34.||0.02|-0.36|0.07
72572633|NCT03056157|144672778|SUPERIORITY||Slope|0.35||||0.002|TWO_SIDED|95.0|0.13|0.57|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for TRGI Hindsight-Bias scores, t(314) = 3.13, d = 0.06.||0.57|0.13|0.002
72534417|NCT01694849|144597530|SUPERIORITY||Difference in least square mean change|-2.35||||0.069|TWO_SIDED|95.0|-4.89|0.19|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|Small dense Low Density Lipoproteins||0.19|-4.89|0.069
72534418|NCT01694849|144597530|SUPERIORITY||Difference in least square mean change|-3.39||||0.01|TWO_SIDED|95.0|-5.95|-0.84|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|Small dense Low Density Lipoproteins||-0.84|-5.95|0.01
72534419|NCT01694849|144597530|SUPERIORITY||Difference in least square mean change|0.84||||0.549|TWO_SIDED|95.0|-1.93|3.61|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|Lp(a)||3.61|-1.93|0.549
72534420|NCT01694849|144597530|SUPERIORITY||Difference in least square mean change|0.49||||0.728|TWO_SIDED|95.0|-2.28|3.26|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|Lp(a)||3.26|-2.28|0.728
72534421|NCT01694849|144597530|SUPERIORITY||Difference in least square mean change|-1.38|||<|0.001|TWO_SIDED|95.0|-2.14|-0.61|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|Apo E||-0.61|-2.14|<0.001
72534422|NCT01694849|144597530|SUPERIORITY||Difference in least square mean change|-1.12||||0.004|TWO_SIDED|95.0|-1.89|-0.36|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|Apo E||-0.36|-1.89|0.004
72534423|NCT01694849|144597530|SUPERIORITY||Difference in least square mean change|-1.18|||<|0.001|TWO_SIDED|95.0|-1.82|-0.53|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|Apo E/B||-0.53|-1.82|<0.001
72534424|NCT01694849|144597530|SUPERIORITY||Difference in least square mean change|-1.08||||0.001|TWO_SIDED|95.0|-1.72|-0.43|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|Apo E/B||-0.43|-1.72|0.001
72534425|NCT01694849|144597531|SUPERIORITY||Difference in least square mean change|-2.8||||0.066|TWO_SIDED|95.0|-5.79|0.18|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Least square mean changes from baseline|||0.18|-5.79|0.066
72534426|NCT01694849|144597531|SUPERIORITY||Difference in least square mean change|0.77||||0.615|TWO_SIDED|95.0|-2.24|3.77|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||3.77|-2.24|0.615
72572634|NCT03056157|144672778|SUPERIORITY||Slope|0.18||||0.03|TWO_SIDED|95.0|0.02|0.34|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for TRGI Hindsight-Bias scores, t(113) = 2.21, d = 0.42.||0.34|0.02|0.03
72572635|NCT03056157|144672778|SUPERIORITY||Slope|-0.17||||0.03|TWO_SIDED|95.0|-0.32|-0.02|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for TRGI Hindsight-Bias scores, t(113) = -2.22, d = 0.42.||-0.02|-0.32|0.03
72572636|NCT03056157|144672779|SUPERIORITY||Slope|0.32||||0.01|TWO_SIDED|95.0|0.06|0.57|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for TRGI Wrongdoing scores, t(314) = 2.46, d = 0.28.||0.57|0.06|0.01
72572637|NCT03056157|144672779|SUPERIORITY||Slope|0.001||||0.95|TWO_SIDED|95.0|-0.17|0.18|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for RGI Wrongdoing scores, t(113) = 0.06, d = 0.01.||0.18|-0.17|0.95
72572638|NCT03056157|144672779|SUPERIORITY||Slope|-0.31||||0.01|TWO_SIDED|95.0|-0.5|-0.13|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for RGI Wrongdoing scores, t(113) = -3.32, d = 0.62.||-0.13|-0.50|0.01
72534427|NCT01694849|144597532|SUPERIORITY||Difference in least square mean change|-17.4||||0.307|TWO_SIDED|95.0|-50.88|16.08|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||16.08|-50.88|0.307
72534428|NCT01694849|144597532|SUPERIORITY||Difference in least square mean change|-21.41||||0.213|TWO_SIDED|95.0|-55.17|12.34|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||12.34|-55.17|0.213
72534429|NCT01694849|144597533|SUPERIORITY||Difference in least square mean change|-0.23||||0.003|TWO_SIDED|95.0|-0.37|-0.08|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||-0.08|-0.37|0.003
72534430|NCT01694849|144597533|SUPERIORITY||Difference in least square mean change|-0.14||||0.068|TWO_SIDED|95.0|-0.29|0.01|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||0.01|-0.29|0.068
72534431|NCT01694849|144597534|SUPERIORITY||Difference in least square mean change|-0.8||||0.448|TWO_SIDED|95.0|-2.86|1.27|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||1.27|-2.86|0.448
72534432|NCT01694849|144597534|SUPERIORITY||Difference in least square mean change|-1.17||||0.267|TWO_SIDED|95.0|-3.25|0.9|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||0.9|-3.25|0.267
72572639|NCT03056157|144672779|SUPERIORITY||Slope|-0.21||||0.04|TWO_SIDED|95.0|-0.41|-0.01|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for TRGI Wrongdoing scores, t(314) = -2.02, d = 0.23.||-0.01|-0.41|0.04
72572640|NCT03056157|144672779|SUPERIORITY||Slope|-0.16||||0.03|TWO_SIDED|95.0|-0.3|-0.02|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for TRGI Wrongdoing scores, t(113) = -2.18, d = 0.03.||-0.02|-0.30|0.03
72534433|NCT01694849|144597535|SUPERIORITY||Difference in least square mean change|-0.05||||0.095|TWO_SIDED|95.0|-0.11|0.01|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||0.01|-0.11|0.095
72534434|NCT01694849|144597535|SUPERIORITY||Difference in least square mean change|-0.07||||0.022|TWO_SIDED|95.0|-0.13|-0.01|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||-0.01|-0.13|0.022
72534435|NCT01694849|144597536|SUPERIORITY||Difference in least square mean change|-0.46||||0.077|TWO_SIDED|95.0|-0.96|0.05|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||0.05|-0.96|0.077
72534436|NCT01694849|144597536|SUPERIORITY||Difference in least square mean change|-0.36||||0.172|TWO_SIDED|95.0|-0.87|0.16|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||0.16|-0.87|0.172
72572641|NCT03056157|144672779|SUPERIORITY||Slope|0.05||||0.48|TWO_SIDED|95.0|-0.09|0.2|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for RGI Wrongdoing scores, t(113) = 0.70, d = 0.13.||0.20|-0.09|0.48
72572642|NCT03056157|144672780|SUPERIORITY||Slope|0.7||||0.45|TWO_SIDED|95.0|-1.12|2.52|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for TRSI scores, t(317) = 0.76, d = 0.09.||2.52|-1.12|0.45
72572643|NCT03056157|144672780|SUPERIORITY||Slope|-1.2||||0.08|TWO_SIDED|95.0|-2.52|0.12|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for TRSI scores, t(113) = -1.79, d = 0.34.||0.12|-2.52|0.08
72626481|NCT00402987|144781767|SUPERIORITY_OR_OTHER_LEGACY|||||||0.235||95.0||||"Based on life-table extension of Mantel-Haenszel method.~p-value for general association"|Mantel Haenszel|||||||0.235
72534437|NCT01694849|144597537|SUPERIORITY||Difference in least square mean change|-0.04||||0.732|TWO_SIDED|95.0|-0.24|0.17|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||0.17|-0.24|0.732
72534438|NCT01694849|144597537|SUPERIORITY||Difference in least square mean change|-0.2||||0.062|TWO_SIDED|95.0|-0.4|0.01|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||0.01|-0.4|0.062
72534439|NCT01694849|144597538|SUPERIORITY||Difference in least square mean change|3.66||||0.4|TWO_SIDED|95.0|-4.89|12.2|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||12.2|-4.89|0.4
72534440|NCT01694849|144597538|SUPERIORITY||Difference in least square mean change|-16.22|||<|0.001|TWO_SIDED|95.0|-24.99|-7.44|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||-7.44|-24.99|<0.001
72534441|NCT01694849|144597539|SUPERIORITY||Difference in least square mean change|-0.36|||<|0.001|TWO_SIDED|95.0|-0.54|-0.17|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|Fibrinogen||-0.17|-0.54|<0.001
72534442|NCT01694849|144597539|SUPERIORITY||Difference in least square mean change|-0.27||||0.005|TWO_SIDED|95.0|-0.46|-0.08|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors||Fibrinogen|Standard error of the least square mean|-0.08|-0.46|0.005
72572644|NCT03056157|144672780|SUPERIORITY||Slope|-1.91||||0.003|TWO_SIDED|95.0|-3.15|-0.66|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for TRSI scores, t(113) = -3.00, d = 0.56.||-0.66|-3.15|0.003
72572645|NCT03056157|144672780|SUPERIORITY||standardized effect size of the slope|-0.29||||0.7|TWO_SIDED|95.0|-1.75|1.17|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for TRSI scores, t(317) = -0.39, d = 0.04.||1.17|-1.75|0.70
72572646|NCT03056157|144672780|SUPERIORITY||Slope|-0.59||||0.27|TWO_SIDED|95.0|-1.64|0.46|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for TRSI scores, t(317) = -1.11, d = 0.12.||0.46|-1.64|0.27
72572647|NCT03056157|144672780|SUPERIORITY||Slope|-0.29||||0.57|TWO_SIDED|95.0|-1.32|0.72|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for TRSI scores, t(317) = -0.57, d = 0.06.||0.72|-1.32|0.57
72572648|NCT03056157|144672781|SUPERIORITY||Slope|3.41||||0.02|TWO_SIDED|95.0|0.56|6.25|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for SOS-10 scores, t(326) = 2.35, d = 0.26.||6.25|0.56|0.02
72572649|NCT03056157|144672781|SUPERIORITY||Slope|6.84|||<|0.001|TWO_SIDED|95.0|4.78|8.9|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for SOS-10 scores, t(116) = -6.53, d = 1.21.||8.90|4.78|<0.001
72626482|NCT00402987|144781767|SUPERIORITY_OR_OTHER_LEGACY|||||||0.012||95.0||||"Based on life-table extension of Mantel-Haenszel method.~p-value for general association"|Mantel Haenszel|||||||0.012
72369216|NCT00611026|144248556|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.1||0.3613|TWO_SIDED|95.0|-0.3|0.1|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.|"Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type:~standard error of the mean."|Treatment difference fesoterodine vs Tolterodine ER at Week 1.||0.1|-0.3|0.3613
72534443|NCT01694849|144597539|SUPERIORITY||Difference in least square mean change|-0.25|||<|0.001|TWO_SIDED|95.0|-0.35|-0.15|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|Haptoglobin||-0.15|-0.35|<0.001
72534444|NCT01694849|144597539|SUPERIORITY||Difference in least square mean change|-0.27|||<|0.001|TWO_SIDED|95.0|-0.37|-0.17|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|Haptoglobin||-0.17|-0.37|<0.001
72534445|NCT01694849|144597540|SUPERIORITY||Difference in least square mean change|0.57||||0.742|TWO_SIDED|95.0|-2.9|4.06|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|Tumour Necrosis Factor alpha||4.06|-2.9|0.742
72534446|NCT01694849|144597540|SUPERIORITY||Difference in least square mean change|2.9||||0.107|TWO_SIDED|95.0|-0.63|6.43|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|Tumour Necrosis Factor alpha||6.43|-0.63|0.107
72534447|NCT01694849|144597540|SUPERIORITY||Difference in least square mean change|0.5||||0.362|TWO_SIDED|95.0|-0.58|1.59|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|Interleukine 6||1.59|-0.58|0.362
72534448|NCT01694849|144597540|SUPERIORITY||Difference in least square mean change|0.07||||0.894|TWO_SIDED|95.0|-1.03|1.18|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|Interleukine 6||1.18|-1.03|0.894
72534449|NCT01694849|144597541|SUPERIORITY||Difference in least square mean change|-0.76||||0.229|TWO_SIDED|95.0|-2.0|0.48|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||0.48|-2|0.229
72534450|NCT01694849|144597541|SUPERIORITY||Difference in least square mean change|-0.45||||0.463|TWO_SIDED|95.0|-1.67|0.76|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||0.76|-1.67|0.463
72534451|NCT01694849|144597542|SUPERIORITY||Difference in least square mean change|-0.21||||0.065|TWO_SIDED|95.0|-0.42|0.01|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||0.01|-0.42|0.065
72534452|NCT01694849|144597542|SUPERIORITY||Difference in least square mean change|-0.19||||0.098|TWO_SIDED|95.0|-0.41|0.03|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||0.03|-0.41|0.098
72534453|NCT01694849|144597543|SUPERIORITY||Difference in least square mean change|0.7||||0.553|TWO_SIDED|95.0|-1.61|3.01|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||3.01|-1.61|0.553
72534454|NCT01694849|144597543|SUPERIORITY||Difference in least square mean change|4.31|||<|0.001|TWO_SIDED|95.0|1.97|6.64|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||6.64|1.97|<0.001
72534455|NCT01694849|144597544|SUPERIORITY||Difference in least square mean change|0.04||||0.861|TWO_SIDED|95.0|-0.37|0.44|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||0.44|-0.37|0.861
72534456|NCT01694849|144597544|SUPERIORITY||Difference in least square mean change|-0.4||||0.052|TWO_SIDED|95.0|-0.81|0.0|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||0|-0.81|0.052
72534457|NCT01694849|144597545|SUPERIORITY||Difference in least square mean change|0.01||||0.473|TWO_SIDED|95.0|-0.01|0.02|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||0.02|-0.01|0.473
72534458|NCT01694849|144597545|SUPERIORITY||Difference in least square mean change|0.01||||0.124|TWO_SIDED|95.0|0.0|0.03|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||0.03|0|0.124
72534459|NCT01694849|144597546|SUPERIORITY||Difference in least square mean change|0.81|||<|0.001|TWO_SIDED|95.0|0.47|1.15|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||1.15|0.47|<0.001
72534460|NCT01694849|144597546|SUPERIORITY||Difference in least square mean change|0.85|||<|0.001|TWO_SIDED|95.0|0.5|1.19|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||1.19|0.5|<0.001
72534461|NCT01694849|144597547|SUPERIORITY||Difference in least square mean change|0.0||||0.842|TWO_SIDED|95.0|-0.04|0.04|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||0.04|-0.04|0.842
72534462|NCT01694849|144597547|SUPERIORITY||Difference in least square mean change|0.01||||0.589|TWO_SIDED|95.0|-0.03|0.05|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||0.05|-0.03|0.589
72534463|NCT01694849|144597548|SUPERIORITY||Difference in least square mean change|48.93||||0.325|TWO_SIDED|95.0|-8.73|146.6|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||146.6|-8.73|0.325
72534464|NCT01694849|144597548|SUPERIORITY||Difference in least square mean change|93.21||||0.066|TWO_SIDED|95.0|-6.06|192.49|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||192.49|-6.06|0.066
72534465|NCT01694849|144597549|SUPERIORITY||Difference in least square mean change|2.41|||<|0.001|TWO_SIDED|95.0|1.1|3.72|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||3.72|1.1|<0.001
72534466|NCT01694849|144597549|SUPERIORITY||Difference in least square mean change|1.59||||0.019|TWO_SIDED|95.0|0.26|2.91|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||2.91|0.26|0.019
72534467|NCT01694849|144597550|SUPERIORITY||Difference in least square mean change|0.0||||0.447|TWO_SIDED|95.0|0.0|0.0|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||0|0|0.447
72534468|NCT01694849|144597550|SUPERIORITY||Difference in least square mean change|0.0||||0.758|TWO_SIDED|95.0|0.0|0.0|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||0|0|0.758
72534469|NCT01694849|144597551|SUPERIORITY||Difference in least square mean change|-0.04||||0.942|TWO_SIDED|95.0|-1.12|1.04|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||1.04|-1.12|0.942
72534470|NCT01694849|144597551|SUPERIORITY||Difference in least square mean change|0.57||||0.304|TWO_SIDED|95.0|-0.52|1.66|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||1.66|-0.52|0.304
72534471|NCT00620191|144597573|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|3.7|STANDARD_DEVIATION|1.92||0.05|TWO_SIDED||||||t-test, 2 sided||The difference is the value for the metformin arm minus the value for the placebo arm.|||||0.05
72534472|NCT00620191|144597573|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|4.1|STANDARD_DEVIATION|1.36||0.05|TWO_SIDED||||||ANCOVA|adjusted for baseline ADAS-Cog value|The difference is the value for the metformin arm minus the value for the placebo arm.|||||0.05
72534473|NCT00620191|144597574|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.98|STANDARD_DEVIATION|1.01||0.06|TWO_SIDED||||||t-test, 2 sided||The difference is the value for the metformin arm minus the value for the placebo arm.|||||0.06
72534474|NCT00620191|144597574|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.9|STANDARD_DEVIATION|0.91||0.34|TWO_SIDED||||||ANCOVA|adjusted for baseline ADAS-Cog score.|The difference is the value for the metformin arm minus the value for the placebo arm.|||||0.34
72534475|NCT00620191|144597575|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.0|STANDARD_DEVIATION|2.14||0.36|TWO_SIDED||||||t-test, 2 sided||The difference is the value for the metformin arm minus the value for the placebo arm.|||||0.36
72534476|NCT00620191|144597576|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|5.09|STANDARD_DEVIATION|4.73||0.34|TWO_SIDED||||||t-test, 2 sided||The difference is the value for the metformin arm minus the value for the placebo arm.|||||0.34
72534477|NCT00145795|144597599|SUPERIORITY_OR_OTHER_LEGACY|||||||0.81||||||The significance level is 5%.|t-test, 2 sided|This is a two-sample t-test assuming equal variances.||Two-sample Student's t-test was used to examine the significance of the difference in mean absolute increase in CD4+ count at 3 months. Under the null hypothesis, CD4+ increase is similar for both treatment groups.||||0.81
72534478|NCT00145795|144597600|SUPERIORITY_OR_OTHER_LEGACY|||||||0.03||||||Significance level is 5%.|t-test, 2 sided|This is a two-sample t-test assuming equal variances.||Two-sample Student's t-test was used to examine the significance of the difference in mean absolute increase in CD4+ count at 6 months. Under the null hypothesis, CD4+ increase is similar for both treatment groups.||||0.03
72534479|NCT00145795|144597601|SUPERIORITY_OR_OTHER_LEGACY|||||||0.08||||||The significance level is 5%.|t-test, 2 sided|This is a two-sample t-test assuming equal variances.||Two-sample Student's t-test was used to assess the difference in mean percent apoptosis for the CD4+ memory cell population at 3 months. Under the null hypothesis, percent CD4+ memory cell apoptosis is similar for both treatment groups.||||0.08
72534480|NCT00145795|144597602|SUPERIORITY_OR_OTHER_LEGACY|||||||0.29||||||The significance level is 5%.|t-test, 2 sided|This is a two-sample t-test assuming equal variances.||Two-sample Student's t-test was used to assess the difference in mean percent apoptosis for the CD4+ naïve cell population at 3 months. Under the null hypothesis, percent CD4+ naïve cell apoptosis is similar for both treatment groups.||||0.29
72534481|NCT00145795|144597603|SUPERIORITY_OR_OTHER_LEGACY|||||||0.29||||||The significance level is 5%.|t-test, 2 sided|This is a two-sample t-test assuming equal variances.||Two-sample Student's t-test was used to assess the difference in mean percent apoptosis for the CD4+ memory cell population at 6 months. Under the null hypothesis, percent CD4+ memory cell apoptosis is similar for both treatment groups.||||0.29
72534482|NCT00145795|144597604|SUPERIORITY_OR_OTHER_LEGACY|||||||0.04||||||The significance level is 5%.|t-test, 2 sided|This is a two-sample t-test assuming equal variances.||Two-sample Student's t-test was used to assess the difference in mean percent apoptosis for the CD4+ naïve cell population at 6 months. Under the null hypothesis, percent CD4+ naïve cell apoptosis is similar for both treatment groups.||||0.04
72534483|NCT00145795|144597605|SUPERIORITY_OR_OTHER_LEGACY|||||||0.21||||||The significance level is 5%.|t-test, 2 sided|This is a two-sample t-test assuming equal variances.||Two-sample Student's t-test was used to assess the difference in mean percent apoptosis for the CD8+ cell population at 3 months. Under the null hypothesis, percent CD8+ cell apoptosis is similar for both treatment groups.||||0.21
72534484|NCT00145795|144597606|SUPERIORITY_OR_OTHER_LEGACY|||||||0.61||||||The significance level is 5%.|t-test, 2 sided|This is a two-sample t-test assuming equal variances.||Two-sample Student's t-test was used to assess the difference in mean percent apoptosis for the CD8+ cell population at 6 months. Under the null hypothesis, percent CD8+ cell apoptosis is similar for both treatment groups.||||0.61
72534485|NCT00570492|144597609|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.27|||||TWO_SIDED|95.0|-0.48|-0.06|||||An analysis of covariance (ANCOVA) was performed to estimate the mean treatment difference in growth velocity over the treatment period, adjusting for baseline growth velocity, age, gender, and country.|||-0.06|-0.48|
72534486|NCT05510297|144597664|SUPERIORITY||Median Difference (Net)|7.0||||0.007|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.007
72534487|NCT05510297|144597665|SUPERIORITY||Mean Difference (Final Values)|2653.16|STANDARD_DEVIATION|5110.86||0.074|TWO_SIDED|95.0|-297.76522|5604.07522||a priori threshold for statistical significance=0.05 for 2-sided t-test; no adjustments for multiple comparisons made; data were checked for normality using the Shapiro-Wilk test where p\>0.05 was interpreted as likely normal distribution.|t-test, 2 sided|||||5604.07522|-297.76522|0.074
72534488|NCT05510297|144597666|SUPERIORITY|a priori threshold for statistical significance=0.05 for 2-sided t-test; no adjustments for multiple comparisons made;|Mean Difference (Net)|4.44067|STANDARD_DEVIATION|41.59009||0.685|TWO_SIDED|95.0|-18.59116|27.47249|||t-test, 2 sided|||||27.47249|-18.59116|0.685
72534489|NCT05510297|144597667|SUPERIORITY||Mean Difference (Net)|-0.51267|STANDARD_DEVIATION|1.44656||0.191|TWO_SIDED|95.0|-1.31374|0.28841|||t-test, 2 sided|||||0.28841|-1.31374|0.191
72534490|NCT05510297|144597668|SUPERIORITY||Mean Difference (Net)|-0.45|STANDARD_DEVIATION|1.35026||0.218|TWO_SIDED|95.0|-1.19775|0.29775|||t-test, 2 sided|||||0.29775|-1.19775|0.218
72534491|NCT05510297|144597669|SUPERIORITY||Mean Difference (Net)|-0.924|STANDARD_DEVIATION|2.19396||0.125|TWO_SIDED|95.0|-2.13898|0.29098|||t-test, 2 sided|||||0.29098|-2.13898|0.125
72534492|NCT05510297|144597670|SUPERIORITY||Mean Difference (Net)|0.00133|STANDARD_DEVIATION|0.10148||0.96|TWO_SIDED|95.0|-0.05486|0.5753|||t-test, 2 sided|||||0.5753|-0.05486|0.960
72534493|NCT05510297|144597674|SUPERIORITY||Mean Difference (Net)|-0.622|STANDARD_DEVIATION|1.6553||0.168|TWO_SIDED|95.0|-1.53867|0.29467|||t-test, 2 sided|||||0.29467|-1.53867|0.168
72534494|NCT04409262|144597675|SUPERIORITY||Hazard Ratio (HR)|0.965||||0.7414|TWO_SIDED|95.0|0.78|1.19|||Log Rank|||||1.19|0.78|0.7414
72534495|NCT04409262|144597676|SUPERIORITY||Hazard Ratio (HR)|0.98||||0.8993|TWO_SIDED|95.0|0.72|1.34|||Log Rank|||||1.34|0.72|0.8993
72534496|NCT04409262|144597677|SUPERIORITY||Odds Ratio (OR)|1.05||||0.7648|TWO_SIDED|95.0|0.77|1.44|||Regression, Logistic|||||1.44|0.77|0.7648
72534497|NCT04409262|144597678|SUPERIORITY||Hazard Ratio (HR)|0.948||||0.7867|TWO_SIDED|95.0|0.65|1.39|||Log Rank|||||1.39|0.65|0.7867
72534498|NCT04409262|144597679|SUPERIORITY||Hazard Ratio (HR)|0.882||||0.4602|TWO_SIDED|95.0|0.63|1.23|||Log Rank|||||1.23|0.63|0.4602
72534499|NCT04409262|144597680|SUPERIORITY||Hazard Ratio (HR)|0.982||||0.8664|TWO_SIDED|95.0|0.8|1.21|||Log Rank|||||1.21|0.80|0.8664
72534500|NCT04409262|144597681|SUPERIORITY||Odds Ratio (OR)|1.01||||0.9569|TWO_SIDED|95.0|0.75|1.35|||Regression, Logistic|||||1.35|0.75|0.9569
72534501|NCT04409262|144597682|SUPERIORITY||Odds Ratio (OR)|1.09||||0.6331|TWO_SIDED|95.0|0.78|1.52|||Regression, Logistic|||||1.52|0.78|0.6331
72534502|NCT04409262|144597683|SUPERIORITY||Odds Ratio (OR)|0.99||||0.9622|TWO_SIDED|95.0|0.7|1.4|||Regression, Logistic|||||1.40|0.70|0.9622
72369217|NCT00611026|144248556|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001|TWO_SIDED|95.0|-0.9|-0.4|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.|"Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type:~standard error of the mean."|Treatment difference fesoterodine vs placebo at Week 4.||-0.4|-0.9|<0.0001
72534503|NCT04409262|144597684|SUPERIORITY||Odds Ratio (OR)|1.14||||0.485|TWO_SIDED|95.0|0.79|1.64|||Regression, Logistic|||||1.64|0.79|0.4850
72534504|NCT04409262|144597685|SUPERIORITY||Weighted % difference|-2.2||||0.5915|TWO_SIDED|95.0|-10.2|5.9|||Cochran-Mantel-Haenszel|||Day 28||5.9|-10.2|0.5915
72534505|NCT04409262|144597685|SUPERIORITY||Weighted % difference|-2.5||||0.5494|TWO_SIDED|95.0|-10.5|5.6|||Cochran-Mantel-Haenszel|||Day 60||5.6|-10.5|0.5494
72534506|NCT04409262|144597686|SUPERIORITY||Weighted % difference|-14.1||||0.259|TWO_SIDED|95.0|-37.4|9.2|||Cochran-Mantel-Haenszel|||Day 28||9.2|-37.4|0.2590
72534507|NCT04409262|144597686|SUPERIORITY||Weighted % difference|-14.6||||0.229|TWO_SIDED|95.0|-37.0|7.8|||Cochran-Mantel-Haenszel|||Day 60||7.8|-37.0|0.2290
72534508|NCT04409262|144597687|SUPERIORITY||Mean Difference (Final Values)|3.1125||||0.2434|TWO_SIDED|95.0|-2.16|8.38|||Regression, Linear|||||8.38|-2.16|0.2434
72534509|NCT04409262|144597688|SUPERIORITY||Weighted % difference|0.6||||0.8222|TWO_SIDED|95.0|-4.4|5.6|||Cochran-Mantel-Haenszel|||Day 14||5.6|-4.4|0.8222
72534510|NCT04409262|144597688|SUPERIORITY||Weighted % difference|-1.3||||0.6944|TWO_SIDED|95.0|-7.8|5.2|||Cochran-Mantel-Haenszel|||Day 28||5.2|-7.8|0.6944
72534511|NCT04409262|144597688|SUPERIORITY||Weighted % difference|-3.0||||0.3919|TWO_SIDED|95.0|-10.1|4.0|||Cochran-Mantel-Haenszel|||Day 60||4.0|-10.1|0.3919
72534512|NCT04409262|144597689|SUPERIORITY||Hazard Ratio (HR)|0.957||||0.6778|TWO_SIDED|95.0|0.78|1.18|||Log Rank|||||1.18|0.78|0.6778
72534513|NCT04409262|144597690|SUPERIORITY||Weighted % difference|-0.9||||0.7692|TWO_SIDED|95.0|-8.7|6.8|||Cochran-Mantel-Haenszel|||||6.8|-8.7|0.7692
72534514|NCT04409262|144597691|SUPERIORITY||Weighted % difference|-0.3||||0.9334|TWO_SIDED|95.0|-7.8|7.2|||Cochran-Mantel-Haenszel|||||7.2|-7.8|0.9334
72534515|NCT03289676|144597705|SUPERIORITY|||||||0.29|||||||Fisher Exact|||||||0.29
72534516|NCT03289676|144597707|OTHER||Odds Ratio, log|1.12||||0.029|TWO_SIDED|95.0|1.0|1.24|||Regression, Logistic|||||1.24|1.00|0.029
72534517|NCT02207413|144597731|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority criterion (for each of the 4 strains): UL of the 95% CI for the GMT ratio (D-QIV\_LP/ D-QIV\_IP) is ≤ 1.5.|Adjusted GMT Ratio|0.97|||||TWO_SIDED|95.0|0.85|1.11|||ANCOVA||The GMTs were used to calculate the Adjusted GMTs, which in turn were used to calculate the Adjusted GMT ratio with 95% confidence interval (Ancova model: adjustment for baseline titer - pooled variance).|The adjusted GMT of HI antibodies for H1N1 strain at post-vaccination of each vaccine, the GMT ratio of Influsplit Tetra\_LP/ Influsplit Tetra\_IP and the 2-sided 95% CI on each GMT ratio were computed after fitting an ANCOVA model on the logarithm10 transformation of the titers, including the vaccine group as fixed effect and the pre-vaccination antibody titer as covariate.||1.11|0.85|
72534518|NCT02207413|144597731|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority criterion (for each of the 4 strains): UL of the 95% CI for the GMT ratio (Influsplit Tetra\_LP/ Influsplit Tetra\_IP) is ≤ 1.5.|Adjusted GMT Ratio|1.05|||||TWO_SIDED|95.0|0.94|1.18|||ANCOVA||The GMTs were used to calculate the Adjusted GMTs, which in turn were used to calculate the Adjusted GMT ratio with 95% confidence interval (Ancova model: adjustment for baseline titer - pooled variance).|The adjusted GMT of HI antibodies for H3N2 strain at post-vaccination of each vaccine, the GMT ratio of Influsplit Tetra\_LP/Influsplit Tetra\_IP and the 2-sided 95% CI on each GMT ratio were computed after fitting an ANCOVA model on the logarithm10 transformation of the titers, including the vaccine group as fixed effect and the pre-vaccination antibody titer as covariate.||1.18|0.94|
72572650|NCT03056157|144672781|SUPERIORITY||Slope|3.43||||0.001|TWO_SIDED|95.0|1.47|5.4|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for SOS-10 scores, t(116) = 3.44, d = 0.64.||5.40|1.47|0.001
72572651|NCT03056157|144672781|SUPERIORITY||Slope|0.76||||0.51|TWO_SIDED|95.0|-1.5|3.03|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for SOS-10 scores, t(326) = 0.66, d = 0.07.||3.03|-1.50|0.51
72572652|NCT03056157|144672781|SUPERIORITY||Slope|-0.27||||0.75|TWO_SIDED|95.0|-1.89|1.35|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for SOS-10 scores, t(326) = -0.32, d = 0.04.||1.35|-1.89|0.75
72572653|NCT03056157|144672781|SUPERIORITY||Slope|-1.03||||0.2|TWO_SIDED|95.0|-2.61|0.55|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for SOS-10 scores, t(326) = -1.28, d = 0.14.||0.55|-2.61|0.20
72572654|NCT03056157|144672782|SUPERIORITY||Slope|0.26||||0.004|TWO_SIDED|95.0|0.08|0.43|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for SCS scores, t(319) = 2.93, d = 0.33.||0.43|0.08|0.004
72572655|NCT03056157|144672782|SUPERIORITY||Slope|0.35|||<|0.001|TWO_SIDED|95.0|0.23|0.48|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for SCS scores, t(114) = 5.56, d = 1.04.||0.48|0.23|<0.001
72408120|NCT03160703|144324645|SUPERIORITY||Mean Difference (Net)|-0.02||||0.2681|TWO_SIDED|95.0|-0.05|0.01||Statistical significance set at 5% level|ANCOVA|From ANCOVA with treatment and smoking status as factors and baseline pre-prophylaxis overall MLSI score as covariate.|Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.|||0.01|-0.05|0.2681
72408121|NCT03160703|144324645|SUPERIORITY||Mean Difference (Net)|-0.05||||0.0043|TWO_SIDED|95.0|-0.08|-0.02||Statistical significance set at 5% level|ANCOVA|From ANCOVA with treatment and smoking status as factors and baseline pre-prophylaxis overall MLSI score as covariate.|Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.|||-0.02|-0.08|0.0043
72534519|NCT02207413|144597731|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority criterion (for each of the 4 strains): UL of the 95% CI for the GMT ratio (Influsplit Tetra\_LP/ Influsplit Tetra\_IP) is ≤ 1.5|Adjusted GMT Ratio|1.03|||||TWO_SIDED|95.0|0.91|1.16|||ANCOVA||The GMTs were used to calculate the Adjusted GMTs, which in turn were used to calculate the Adjusted GMT ratio with 95% confidence interval (Ancova model: adjustment for baseline titer - pooled variance).|The adjusted GMT of HI antibodies for Yamagata strain at post-vaccination of each vaccine, the GMT ratio of Influsplit Tetra\_LP/Influsplit Tetra\_IP and the 2-sided 95% CI on each GMT ratio were computed after fitting an ANCOVA model on the logarithm10 transformation of the titers, including the vaccine group as fixed effect and the pre-vaccination antibody titer as covariate.||1.16|0.91|
72572656|NCT03056157|144672782|SUPERIORITY||Slope|0.1||||0.11|TWO_SIDED|95.0|-0.02|0.22|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for SCS scores, t(114) = 1.61, d = 0.30.||0.22|-0.02|0.11
72534520|NCT02207413|144597731|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority criterion (for each of the 4 strains): UL of the 95% CI for the GMT ratio (Influsplit Tetra\_LP/ Influsplit Tetra\_IP) is ≤ 1.5.|Adjusted GMT Ratio|1.04|||||TWO_SIDED|95.0|0.9|1.21|||ANCOVA||The GMTs were used to calculate the Adjusted GMTs, which in turn were used to calculate the Adjusted GMT ratio with 95% confidence interval (Ancova model: adjustment for baseline titer - pooled variance).|The adjusted GMT of HI antibodies for Victoria strain at post-vaccination of each vaccine, the GMT ratio of Influsplit Tetra\_LP/Influsplit Tetra\_IP and the 2-sided 95% CI on each GMT ratio were computed after fitting an ANCOVA model on the logarithm10 transformation of the titers, including the vaccine group as fixed effect and the pre-vaccination antibody titer as covariate.||1.21|0.90|
72572657|NCT03056157|144672782|SUPERIORITY||Slope|0.007||||0.92|TWO_SIDED|95.0|-0.13|0.15|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for SCS scores, t(319) = 0.10, d = 0.10.||0.15|-0.13|0.92
72626483|NCT00402987|144781767|SUPERIORITY_OR_OTHER_LEGACY|||||||0.438||95.0||||"Based on life-table extension of Mantel-Haenszel method.~p-value for general association"|Mantel Haenszel|||||||0.438
72572658|NCT03056157|144672782|SUPERIORITY||Slope|0.02||||0.75|TWO_SIDED|95.0|-0.08|0.12|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for SCS scores, t(319) = 0.31, d = 0.03.||0.12|-0.08|0.75
72572659|NCT03056157|144672782|SUPERIORITY||Slope|0.01||||0.86|TWO_SIDED|95.0|-0.09|0.11|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for SCS scores, t(319) = 0.18, d = 0.02.||0.11|-0.09|0.86
72572660|NCT03056157|144672783|SUPERIORITY||Slope|-2.56||||0.15|TWO_SIDED|95.0|-6.1|0.97|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for DAR scores, t(325) = -1.43, d = 0.16.||0.97|-6.10|0.15
72572661|NCT03056157|144672783|SUPERIORITY||Slope|-5.28|||<|0.001|TWO_SIDED|95.0|-7.83|-2.73|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for DAR scores, t(116) = -4.07, d = 0.76||-2.73|-7.83|<0.001
72572662|NCT03056157|144672783|SUPERIORITY||Slope|-2.71||||0.03|TWO_SIDED|95.0|-5.16|-0.28|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for DAR scores, t(116) = -2.19, d = 0.41.||-0.28|-5.16|0.03
72572663|NCT03056157|144672783|SUPERIORITY||Slope|-1.38||||0.33|TWO_SIDED|95.0|-4.17|1.42|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for DAR scores, t(325) = -0.97, d = 0.11.||1.42|-4.17|0.33
72572664|NCT03056157|144672783|SUPERIORITY||Slope|-1.54||||0.13|TWO_SIDED|95.0|-3.54|0.46|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for DAR scores, t(325) = -1.51, d = 0.17.||0.46|-3.54|0.13
72572665|NCT03056157|144672783|SUPERIORITY||Slope|-0.17||||0.87|TWO_SIDED|95.0|-2.12|1.79|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for DAR scores, t(325) = -0.17, d = 0.02.||1.79|-2.12|0.87
72572666|NCT03056157|144672784|SUPERIORITY||Slope|-0.37||||0.04|TWO_SIDED|95.0|-0.72|-0.01|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for CTS2 Psychological Aggression scores, t(319) = -2.03, d = 0.23.||-0.01|-0.72|0.04
72572667|NCT03056157|144672784|SUPERIORITY||Slope|-0.83|||<|0.001|TWO_SIDED|95.0|-1.09|-0.58|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for CTS2 Psychological Aggression scores, t(116)= -6.40, d = 1.19.||-0.58|-1.09|<0.001
72626484|NCT00402987|144781767|SUPERIORITY_OR_OTHER_LEGACY|||||||0.067||95.0||||"Based on life-table extension of Mantel-Haenszel method.~p-value for general association"|Mantel Haenszel|||||||0.067
72408122|NCT03160703|144324645|SUPERIORITY||Mean Difference (Net)|-0.08|||<|0.0001|TWO_SIDED|95.0|-0.12|-0.05||Statistical significance set at 5% level|ANCOVA|From ANCOVA with treatment and smoking status as factors and baseline pre-prophylaxis overall MLSI score as covariate.|Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.|||-0.05|-0.12|<.0001
72572668|NCT03056157|144672784|SUPERIORITY||Slope|-0.47||||0.002|TWO_SIDED|95.0|-0.71|-0.22|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for CTS2 Psychological Aggression scores, t(116) = -3.78, d = 0.70.||-0.22|-0.71|0.002
72572669|NCT03056157|144672784|SUPERIORITY||Slope|-0.08||||0.58|TWO_SIDED|95.0|-0.37|0.21|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for CTS2 Psychological Aggression scores, t(319) = -0.56, d = 0.06.||0.21|-0.37|0.58
72572670|NCT03056157|144672784|SUPERIORITY||Slope|-0.1||||0.34|TWO_SIDED|95.0|-0.31|0.11|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for CTS2 Psychological Aggression scores, t(319) = -0.96, d = 0.11.||0.11|-0.31|0.34
72572671|NCT03056157|144672784|SUPERIORITY||Slope|-0.02||||0.85|TWO_SIDED|95.0|-0.22|0.18|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for CTS2 Psychological Aggression scores, t(319) = -0.19, d = 0.02.||0.18|-0.22|0.85
72626485|NCT00402987|144781768|SUPERIORITY_OR_OTHER_LEGACY|||||||0.128||95.0||||"Based on life-table extension of Mantel-Haenszel method.~p-value for general association"|Mantel Haenszel|||||||0.128
72534521|NCT02207413|144597732|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority criterion (for each of the 4 strains): UL of the 95% CI for the GMT ratio (Influsplit Tetra\_LP/Influsplit Tetra\_IP) is ≤ 1.5.|Adjusted GMT ratio|1.07|||||TWO_SIDED|95.0|0.9|1.28|||ANCOVA|||The adjusted GMT of HI antibodies for H1N1 strain at post-vaccination of each vaccine, the GMT ratio of Influsplit Tetra\_LP/Influsplit Tetra\_IP and the 2-sided 95% CI on each GMT ratio were computed after fitting an ANCOVA model on the logarithm10 transformation of the titers, including the vaccine group as fixed effect and the pre-vaccination antibody titer as covariate.||1.28|0.90|
72534522|NCT02207413|144597732|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority criterion (for each of the 4 strains): UL of the 95% CI for the GMT ratio (Influsplit Tetra\_LP/Influsplit Tetra\_IP) is ≤ 1.5|Adjusted GMT Ratio|1.18|||||TWO_SIDED|95.0|1.0|1.39|||ANCOVA||The GMTs were used to calculate the Adjusted GMTs, which in turn were used to calculate the Adjusted GMT ratio with 95% confidence interval (Ancova model: adjustment for baseline titer - pooled variance).|The adjusted GMT of HI antibodies for H3N2 strain at post-vaccination of each vaccine, the GMT ratio of Influsplit Tetra\_LP/Influsplit Tetra\_IP and the 2-sided 95% CI on each GMT ratio were computed after fitting an ANCOVA model on the logarithm10 transformation of the titers, including the vaccine group as fixed effect and the pre-vaccination antibody titer as covariate.||1.39|1.00|
72534523|NCT02207413|144597732|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority criterion (for each of the 4 strains): UL of the 95% CI for the GMT ratio (Influsplit Tetra\_LP/Influsplit Tetra\_IP) is ≤ 1.5.|Adjusted GMT Ratio|1.07|||||TWO_SIDED|95.0|0.91|1.27|||ANCOVA|||The adjusted GMT of HI antibodies for Yamagata strain at post-vaccination of each vaccine, the GMT ratio of Influsplit Tetra\_LP/Influsplit Tetra\_IP and the 2-sided 95% CI on each GMT ratio were computed after fitting an ANCOVA model on the logarithm10 transformation of the titers, including the vaccine group as fixed effect and the pre-vaccination antibody titer as covariate.||1.27|0.91|
72534524|NCT02207413|144597732|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority criterion (for each of the 4 strains): UL of the 95% CI for the GMT ratio (Influsplit Tetra\_LP/Influsplit Tetra\_IP) is ≤ 1.5.|Adjusted GMT Ratio|1.17|||||TWO_SIDED|95.0|0.99|1.38|||ANCOVA||The GMTs were used to calculate the Adjusted GMTs, which in turn were used to calculate the Adjusted GMT ratio with 95% confidence interval (Ancova model: adjustment for baseline titer - pooled variance).|The adjusted GMT of HI antibodies for Victoria strain at post-vaccination of each vaccine, the GMT ratio of Influsplit Tetra\_LP/Influsplit Tetra\_IP and the 2-sided 95% CI on each GMT ratio were computed after fitting an ANCOVA model on the logarithm10 transformation of the titers, including the vaccine group as fixed effect and the pre-vaccination antibody titer as covariate||1.38|0.99|
72534525|NCT01241591|144597756|NON_INFERIORITY_OR_EQUIVALENCE|The a priori threshold for non-inferiority was -15% and a step-down approach was used to adjust for multiple comparisons. Non-inferiority of CP-690,550 5 mg to etanercept was concluded if the 95% lower confidence intervals (LCIs) of the difference for PGA and Psoriasis Area and Severity Index 75 (PASI75) responses at Week 12 were greater than -15%, and CP-690,550 10 mg was superior to placebo for PGA response and PASI75 at Week 12.|Mean Difference|-19.16|STANDARD_ERROR_OF_MEAN|3.77|||TWO_SIDED|95.0|-26.55|-11.76||||||Difference from Etanercept (Active-Etanercept)||-11.76|-26.55|
72534526|NCT01241591|144597756|SUPERIORITY_OR_OTHER||Mean Difference|32.16|STANDARD_ERROR_OF_MEAN|4.41|||TWO_SIDED|95.0|23.51|40.81||||||Difference from Placebo (Active-Placebo); the a priori threshold for superiority was 0 and a step-down approach was used to adjust for multiple comparisons. Superiority of CP-690,550 5 mg to placebo was concluded if the lower bounds of the 95% LCIs of the difference for PGA and PASI75 responses at Week 12 were greater than 0, and non-inferiority of CP-690,550 5 mg was concluded to be non-inferior to etanercept.||40.81|23.51|
72534527|NCT01241591|144597756|NON_INFERIORITY_OR_EQUIVALENCE|The a priori threshold for non-inferiority was -15% and a step-down approach was used to adjust for multiple comparisons. Non-inferiority of CP-690,550 10 mg to etanercept was concluded if the 95% LCIs of the difference for PGA and PASI75 responses at Week 12 were greater than -15%.|Mean Difference|1.91|STANDARD_ERROR_OF_MEAN|3.64|||TWO_SIDED|95.0|-5.22|9.05||||||Difference from Etanercept (Active-Etanercept)||9.05|-5.22|
72534528|NCT01241591|144597756|SUPERIORITY_OR_OTHER||Mean Difference|53.23|STANDARD_ERROR_OF_MEAN|4.3|||TWO_SIDED|95.0|44.81|61.65||||||Difference from Placebo (Active-Placebo); the a priori threshold for superiority was 0 and a step-down approach was used to adjust for multiple comparisons. Superiority of CP-690,550 10 mg to placebo was concluded if the 95% LCIs of the difference for PGA and PASI75 responses at Week 12 were greater than 0, and non-inferiority of CP-690,550 10 mg was concluded to be non-inferior to etanercept.||61.65|44.81|
72534529|NCT01241591|144597757|NON_INFERIORITY_OR_EQUIVALENCE|The a priori threshold for non-inferiority was -15% and a step-down approach was used to adjust for multiple comparisons. Non-inferiority of CP-690,550 5 mg to etanercept was concluded if the 95% LCIs of the difference for PGA and PASI75 responses at Week 12 were greater than -15%, and CP-690,550 10 mg was superior to placebo for PGA and PASI75 response at Week 12.|Mean Difference|-19.29|STANDARD_ERROR_OF_MEAN|3.81|||TWO_SIDED|95.0|-26.75|-11.83||||||Difference from Etanercept (Active-Etanercept)||-11.83|-26.75|
72534530|NCT01241591|144597757|SUPERIORITY_OR_OTHER||Mean Difference|33.91|STANDARD_ERROR_OF_MEAN|3.49|||TWO_SIDED|95.0|27.06|40.76||||||Difference from Placebo (Active-Placebo); the a priori threshold for superiority was 0 and a step-down approach was used to adjust for multiple comparisons. Superiority of CP-690,550 5 mg to placebo was concluded if the 95% LCIs of the difference for PGA and PASI75 responses at Week 12 were greater than 0, and non-inferiority of CP-690,550 5 mg was concluded to be non-inferior to etanercept.||40.76|27.06|
72534531|NCT01241591|144597757|NON_INFERIORITY_OR_EQUIVALENCE|The a priori threshold for non-inferiority was -15% and a step-down approach was used to adjust for multiple comparisons. Non-inferiority of CP-690,550 10 mg to etanercept was concluded if the 95% LCIs of the difference for PGA and PASI75 responses at Week 12 were greater than -15%.|Mean Difference|4.83|STANDARD_ERROR_OF_MEAN|3.77|||TWO_SIDED|95.0|-2.57|12.23||||||Difference from Etanercept (Active-Etanercept)||12.23|-2.57|
72534532|NCT01241591|144597757|SUPERIORITY_OR_OTHER||Mean Difference|58.03|STANDARD_ERROR_OF_MEAN|3.46|||TWO_SIDED|95.0|51.25|64.81||||||Difference from Placebo (Active-Placebo); the a priori threshold for superiority was 0 and a step-down approach was used to adjust for multiple comparisons. Superiority of CP-690,550 10 mg to placebo was concluded if the 95% LCIs of the difference for PGA and PASI75 responses at Week 12 were greater than 0, and non-inferiority of CP-690,550 10 mg was concluded to be non-inferior to etanercept.||64.81|51.25|
72626486|NCT00402987|144781768|SUPERIORITY_OR_OTHER_LEGACY|||||||0.123||95.0||||"Based on life-table extension of Mantel-Haenszel method.~p-value for general association"|Mantel Haenszel|||||||0.123
72408123|NCT03160703|144324645|SUPERIORITY||Mean Difference (Final Values)|-0.11|||<|0.0001|TWO_SIDED|95.0|-0.15|-0.08||Statistical significance set at 5% level|ANCOVA|From ANCOVA with treatment and smoking status as factors and baseline pre-prophylaxis overall MLSI score as covariate.|Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.|||-0.08|-0.15|<.0001
72534533|NCT01945034|144597802|SUPERIORITY_OR_OTHER||LS Mean Difference|23.0||||0.19|TWO_SIDED|95.0|-11.49|57.56||p-value \<=0.05 for treatment effects|ANOVA|||The analysis of variance (ANOVA) model was used which contains treatment, baseline categorical pain severity rating, pooled site blocks, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||57.56|-11.49|0.190
72534534|NCT01945034|144597802|SUPERIORITY_OR_OTHER||LS Mean Difference|7.8||||0.633|TWO_SIDED|95.0|-24.2|39.7||p-value \<=0.05 for treatment effects|ANOVA|||The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site blocks, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||39.70|-24.20|0.633
72534535|NCT01945034|144597802|SUPERIORITY_OR_OTHER||LS Mean Difference|-15.3||||0.436|TWO_SIDED|95.0|-53.87|23.3||p-value \<=0.05 for treatment effects|ANOVA|||The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site blocks, and baseline pain intensity on weight bearing terms.||23.30|-53.87|0.436
72534536|NCT01945034|144597803|SUPERIORITY_OR_OTHER||Least Squares (LS) Mean Difference|4.8||||0.426|TWO_SIDED|95.0|-6.98|16.49||p-value \<=0.05 for treatment effects|ANOVA|||The ANOVA model was used which contains treatment, baseline categorical pain severity rating (BLPSR), pooled site blocks, and baseline pain intensity on weight bearing (BLPIWB) terms. 95% CI not includes 0 for treatment effect. Upper limit of 95% CI\< 0 for Ibuprofen treatment significantly better than combined Placebo. Comparison: tested at the 0.05 level of significance (2-sided). A comparison was eligible for being declared significant only if preceding comparison was significant.||16.49|-6.98|0.426
72534537|NCT01945034|144597803|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.0||||0.85|TWO_SIDED|95.0|-11.9|9.82||p-value \<=0.05 for treatment effects|ANOVA|||The ANOVA model was used which contains treatment, BLPSR, pooled site blocks, and BLPIWB terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo. Comparison: tested at the 0.05 level of significance (2-sided). A comparison was eligible for being declared significant only if preceding comparison was significant.||9.82|-11.90|0.850
72534538|NCT01945034|144597803|SUPERIORITY_OR_OTHER||LS Mean Difference|-5.8||||0.385|TWO_SIDED|95.0|-18.91|7.32||p-value \<=0.05 for treatment effects|ANOVA|||The ANOVA model was used which contains treatment, BLPSR, pooled site blocks, and BLPIWB terms. A comparison was eligible for being declared significant only if preceding comparison was significant.||7.32|-18.91|0.385
72534539|NCT01945034|144597804|SUPERIORITY_OR_OTHER||LS Mean Difference|10.0||||0.072|TWO_SIDED|95.0|-0.92|20.91||p-value \<=0.05 for treatment effects|ANOVA|||The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site blocks, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||20.91|-0.92|0.072
72534540|NCT01945034|144597804|SUPERIORITY_OR_OTHER||LS Mean Difference|-5.3||||0.296|TWO_SIDED|95.0|-15.4|4.7||p-value \<=0.05 for treatment effects|ANOVA|||The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site blocks, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||4.70|-15.40|0.296
72534541|NCT01945034|144597804|SUPERIORITY_OR_OTHER||LS Mean Difference|-15.3||||0.014|TWO_SIDED|95.0|-27.53|-3.16||p-value \<=0.05 for treatment effects|ANOVA|||The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site blocks, and baseline pain intensity at rest terms.||-3.16|-27.53|0.014
72534542|NCT01945034|144597805|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1||||0.305|TWO_SIDED|95.0|-0.1|0.3||p-value \<=0.05 for treatment effects|ANOVA|||Day 3: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline participant global assessment terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo||0.30|-0.10|0.305
72534543|NCT01945034|144597805|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1||||0.261|TWO_SIDED|95.0|-0.08|0.29||p-value \<=0.05 for treatment effects|ANOVA|||Day 3: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline participant global assessment terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.29|-0.08|0.261
72534544|NCT01945034|144597805|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0||||0.996|TWO_SIDED|95.0|-0.22|0.22||p-value \<=0.05 for treatment effects|ANOVA|||Day 3: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline participant global assessment terms.||0.22|-0.22|0.996
72534545|NCT01945034|144597805|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1||||0.21|TWO_SIDED|95.0|-0.08|0.36||p-value \<=0.05 for treatment effects|ANOVA|||Day 10: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline participant global assessment terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.36|-0.08|0.210
72534546|NCT01945034|144597805|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1||||0.556|TWO_SIDED|95.0|-0.14|0.27||p-value \<=0.05 for treatment effects|ANOVA|||Day 10: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline participant global assessment terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.27|-0.14|0.556
72534547|NCT01945034|144597805|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1||||0.534|TWO_SIDED|95.0|-0.33|0.17||p-value \<=0.05 for treatment effects|ANOVA|||Day 10: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline participant global assessment terms.||0.17|-0.33|0.534
72534548|NCT01945034|144597806|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1||||0.354|TWO_SIDED|95.0|-0.27|0.1||p-value \<=0.05 for treatment effects|ANOVA|||Day 3: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline physician global assessment terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.10|-0.27|0.354
72408124|NCT03160703|144324645|SUPERIORITY||Mean Difference (Final Values)|0.03||||0.0779|TWO_SIDED|95.0|0.0|0.06||Statistical significance set at 5% level|ANCOVA|From ANCOVA with treatment and smoking status as factors and baseline pre-prophylaxis overall MLSI score as covariate.|Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.|||0.06|-0.00|0.0779
72408125|NCT03160703|144324645|SUPERIORITY||Mean Difference (Final Values)|0.07||||0.0001|TWO_SIDED|95.0|0.03|0.1||Statistical significance set at 5% level|ANCOVA|From ANCOVA with treatment and smoking status as factors and baseline pre-prophylaxis overall MLSI score as covariate.|Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.|||0.10|0.03|0.0001
72408126|NCT00047463|144324669|SUPERIORITY_OR_OTHER|||||||0.26|||||||Wilcoxon (Mann-Whitney)|||The null hypothesis was that the groups would be similar in tolerance. This was a pilot study so we did not do a power calculation.||||0.26
72408127|NCT04589559|144324679|OTHER|Paired-samples t-test|Mean change score|-1.5||||0.152|TWO_SIDED|95.0|-3.67|0.67|||t-test, 2 sided|Paired-samples t-test|A negative value of the estimation parameter of mean change score indicates a reduction in cardiac-related interoceptive fear.|||0.67|-3.67|0.152
72408128|NCT04589559|144324680|OTHER|Paired-samples t-test|Mean change score|-6.2||||0.031|TWO_SIDED|95.0|-11.71|-0.69|||t-test, 2 sided|Paired-samples t-test|A negative value of the estimation parameter of mean change score indicates a reduction in trait anxiety.|||-0.69|-11.71|0.031
72408129|NCT04589559|144324681|OTHER|Paired-samples t-test|Mean change score|-1.9||||0.323|TWO_SIDED|95.0|-6.01|2.21|||t-test, 2 sided|Paired-samples t-test|A negative value of the estimation parameter of mean change score indicates a reduction in negative affect.|||2.21|-6.01|0.323
72534549|NCT01945034|144597806|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1||||0.237|TWO_SIDED|95.0|-0.28|0.07||p-value \<=0.05 for treatment effects|ANOVA|||Day 3: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.07|-0.28|0.237
72534550|NCT01945034|144597806|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0||||0.871|TWO_SIDED|95.0|-0.23|0.19||p-value \<=0.05 for treatment effects|ANOVA|||Day 3: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline physician global assessment terms.||0.19|-0.23|0.871
72534551|NCT01945034|144597806|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2||||0.05|TWO_SIDED|95.0|-0.43|0.0||p-value \<=0.05 for treatment effects|ANOVA|||Day 10: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline physician global assessment terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||-0.00|-0.43|0.050
72572672|NCT03056157|144672785|SUPERIORITY|We log-transformed CTS2 scores because they were heavily positively skewed in conjunction with zero-inflation.|Slope|-0.23||||0.07|TWO_SIDED|95.0|-0.48|0.02|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for CTS2 Physical Assault scores, t(319)= -1.82, d = 0.20.||0.02|-0.48|0.07
72572673|NCT03056157|144672785|SUPERIORITY||Slope|-0.13||||0.17|TWO_SIDED|95.0|-0.31|-0.05|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for CTS2 Physical Assault scores, t(116) = -1.39, d = 0.16.||-0.05|-0.31|0.17
72572674|NCT03056157|144672785|SUPERIORITY||Slope|0.1||||0.24|TWO_SIDED|95.0|-0.07|0.27|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for CTS2 Physical Assault scores, t(116) = 1.18, d = 0.13.||0.27|-0.07|0.24
72408130|NCT04589559|144324682|OTHER|Paired-samples t-test|Mean change in the measure|0.58||||0.112|TWO_SIDED|95.0|-0.16|1.33|||t-test, 2 sided|Paired-samples t-test|A positive value of the estimation parameter of mean change in the measure indicates an increase in heart rate variability.|||1.33|-0.16|0.112
72408131|NCT01448850|144324695|SUPERIORITY_OR_OTHER||Rate ratio|0.92||||0.645|TWO_SIDED|90.0|0.68|1.25||Data was analyzed using Poisson regression with Pearson correction, adjusting for treatment, background therapy and history of previous exacerbations.|Poisson regression|||||1.25|0.68|0.645
72408132|NCT02214147|144324716|OTHER|The effect of hepatic impairment on alisertib PK. Combined analysis of moderate and severe hepatic impairment in reference to normal hepatic function.|Least Squares Geometric Mean Ratio|1.42|||||TWO_SIDED|90.0|1.12|1.8|||||Least Squares Geometric Means Ratio= Moderate + Severe Hepatic Impairment/Normal Hepatic Function|||1.80|1.12|
72408133|NCT02214147|144324717|OTHER|The effect of hepatic impairment on alisertib PK. Combined analysis of moderate and severe hepatic impairment in reference to normal hepatic function.|Least Squares Geometric Mean Ratio|3.21|||||TWO_SIDED|90.0|2.33|4.43|||||Least Squares Geometric Mean Ratio=Moderate + Severe Hepatic Impairment/Normal Hepatic Function|||4.43|2.33|
72408134|NCT02214147|144324718|OTHER|The effect of hepatic impairment on alisertib PK. Combined analysis of moderate and severe hepatic impairment in reference to normal hepatic function.|Least Squares Geometric Mean Ratio|2.54|||||TWO_SIDED|90.0|1.84|3.53|||||Least Squares Geometric Mean Ratio=Moderate + Severe Hepatic Impairment/Normal Hepatic Function|||3.53|1.84|
72534552|NCT01945034|144597806|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0||||0.64|TWO_SIDED|95.0|-0.25|0.15||p-value \<=0.05 for treatment effects|ANOVA|||Day 10: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline physician global assessment terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.15|-0.25|0.640
72534553|NCT01945034|144597806|SUPERIORITY_OR_OTHER||LS Mean Difference|0.2||||0.18|TWO_SIDED|95.0|-0.08|0.41||p-value \<=0.05 for treatment effects|ANOVA|||Day 10: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline physician global assessment terms.||0.41|-0.08|0.180
72572675|NCT03056157|144672785|SUPERIORITY||Slope|0.11||||0.71|TWO_SIDED|95.0|-0.23|0.15|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for CTS2 Physical Assault scores, t(319) = -0.37, d = 0.04.||0.15|-0.23|0.71
72572676|NCT03056157|144672785|SUPERIORITY||Slope|-0.07||||0.32|TWO_SIDED|95.0|-0.21|0.07|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for CTS2 Physical Assault scores, t(319) = -1.00, d = 0.11.||0.07|-0.21|0.32
72572677|NCT03056157|144672785|SUPERIORITY||Slope|-0.04||||0.61|TWO_SIDED|95.0|-0.17|0.1|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for CTS2 Physical Assault scores, t(319) = -0.51, d = 0.06.||0.10|-0.17|0.61
72572678|NCT03056157|144672786|SUPERIORITY||Slope|-0.07||||0.74|TWO_SIDED|95.0|-0.5|0.36|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for DSI-SS scores, t(318) = -0.33, d = 0.04||0.36|-0.50|0.74
72572679|NCT03056157|144672786|SUPERIORITY||Slope|-0.12||||0.44|TWO_SIDED|95.0|-0.43|0.19|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for DSI-SS scores, t(114) = -0.77, d = 0.14.||0.19|-0.43|0.44
72572680|NCT03056157|144672786|SUPERIORITY||Slope|-0.06||||0.74|TWO_SIDED|95.0|-0.35|0.24|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for DSI-SS scores, t(114) = -0.34, d = 0.06.||0.24|-0.35|0.74
72408135|NCT05421078|144324734|SUPERIORITY||Least Squares (LS) Means|-25.84|STANDARD_ERROR_OF_MEAN|5.387|<|0.0001|TWO_SIDED|95.0|-36.53|-15.14||p value is calculated|Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-15.14|-36.53|<.0001
72534554|NCT01945034|144597807|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1||||0.771|TWO_SIDED|95.0|-0.38|0.51|||ANOVA|||At Rest 1 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.51|-0.38|0.771
72534555|NCT01945034|144597807|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.5||||0.022|TWO_SIDED|95.0|-0.88|-0.07|||ANOVA|p-value \<=0.05 for treatment effects||At Rest 1 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||-0.07|-0.88|0.022
72534556|NCT01945034|144597807|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.5||||0.032|TWO_SIDED|95.0|-1.03|-0.05|||ANOVA|p-value \<=0.05 for treatment effects||At Rest 1 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.||-0.05|-1.03|0.032
72534557|NCT01945034|144597807|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1||||0.72|TWO_SIDED|95.0|-0.38|0.55|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing 1 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.55|-0.38|0.720
72534558|NCT01945034|144597807|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3||||0.194|TWO_SIDED|95.0|-0.71|0.15|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing 1 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.15|-0.71|0.194
72534559|NCT01945034|144597807|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4||||0.163|TWO_SIDED|95.0|-0.89|0.15|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing 1 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.||0.15|-0.89|0.163
72534560|NCT01945034|144597807|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1||||0.644|TWO_SIDED|95.0|-0.4|0.64|||ANOVA|p-value \<=0.05 for treatment effects||At Rest 2 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.64|-0.40|0.644
72534561|NCT01945034|144597807|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4||||0.129|TWO_SIDED|95.0|-0.85|0.11|||ANOVA|p-value \<=0.05 for treatment effects||At Rest 2 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.11|-0.85|0.129
72534562|NCT01945034|144597807|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.5||||0.096|TWO_SIDED|95.0|-1.07|0.09|||ANOVA|p-value \<=0.05 for treatment effects||At Rest 2 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.||0.09|-1.07|0.096
72572681|NCT03056157|144672786|SUPERIORITY||Slope|-0.1||||0.57|TWO_SIDED|95.0|-0.45|0.25|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for DSI-SS scores, t(114) = -0.57, d = 0.11.||0.25|-0.45|0.57
72626487|NCT00402987|144781768|SUPERIORITY_OR_OTHER_LEGACY|||||||0.266||95.0||||"Based on life-table extension of Mantel-Haenszel method.~p-value for general association"|Mantel Haenszel|||||||0.266
72626488|NCT00402987|144781768|SUPERIORITY_OR_OTHER_LEGACY|||||||0.849||95.0||||"Based on life-table extension of Mantel-Haenszel method.~p-value for general association"|Mantel Haenszel|||||||0.849
72626489|NCT00402987|144781768|SUPERIORITY_OR_OTHER_LEGACY|||||||0.828||95.0||||"Based on life-table extension of Mantel-Haenszel method.~p-value for general association"|Mantel Haenszel|||||||0.828
72408136|NCT05421078|144324734|SUPERIORITY||Least Squares (LS) Means|-33.34|STANDARD_ERROR_OF_MEAN|5.378|<|0.0001|TWO_SIDED|95.0|-44.01|-22.66||p value is calculated|Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-22.66|-44.01|<.0001
72408137|NCT05421078|144324734|SUPERIORITY||Least Squares (LS) Means|-36.12|STANDARD_ERROR_OF_MEAN|5.323|<|0.0001|TWO_SIDED|95.0|-46.68|-25.55||p value is calculated|Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-25.55|-46.68|<.0001
72572682|NCT03056157|144672786|SUPERIORITY||Slope|-0.03||||0.82|TWO_SIDED|95.0|-0.28|0.22|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for DSI-SS scores, t(114) = -0.23, d = 0.04.||0.22|-0.28|0.82
72572683|NCT03056157|144672786|SUPERIORITY||Slope|0.07||||0.57|TWO_SIDED|95.0|-0.17|0.31|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for DSI-SS scores, t(114) = 0.58, d = 0.11.||0.31|-0.17|0.57
72572684|NCT03056157|144672787|SUPERIORITY||Slope|-1.1||||0.16|TWO_SIDED|95.0|-2.63|0.43|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for QDS scores, t(316) = -1.42, d = 0.16.||0.43|-2.63|0.16
72572685|NCT03056157|144672787|SUPERIORITY||Slope|-0.76||||0.18|TWO_SIDED|95.0|-1.87|0.35|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for QDS scores, t(114)= -1.35, d = 0.25.||0.35|-1.87|0.18
72572686|NCT03056157|144672787|SUPERIORITY||Slope|0.34||||0.53|TWO_SIDED|95.0|-0.71|1.39|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for QDS scores, t(114) = 0.63, d = 0.12.||1.39|-0.71|0.53
72626490|NCT00402987|144781768|SUPERIORITY_OR_OTHER_LEGACY|||||||0.741||95.0||||"Based on life-table extension of Mantel-Haenszel method.~p-value for general association"|Mantel Haenszel|||||||0.741
72626491|NCT05528770|144781769|SUPERIORITY||Mean Difference (Final Values)|2.23|STANDARD_DEVIATION|8.98||0.4291|TWO_SIDED|95.0|-3.8|8.3|||t-test, 2 sided|||||8.3|-3.8|0.4291
72408138|NCT05421078|144324735|SUPERIORITY||Least Squares (LS) Means|-25.84|STANDARD_ERROR_OF_MEAN|5.387|<|0.0001|TWO_SIDED|95.0|-36.53|-15.14|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||p value is calculated||-15.14|-36.53|<.0001
72408139|NCT05421078|144324735|SUPERIORITY||Least Squares (LS) Means|-33.34|STANDARD_ERROR_OF_MEAN|5.378|<|0.0001|TWO_SIDED|95.0|-44.01|-22.66||p value is calculated|Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-22.66|-44.01|<.0001
72534563|NCT01945034|144597807|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0||||0.905|TWO_SIDED|95.0|-0.5|0.57|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing 2 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.57|-0.50|0.905
72534564|NCT01945034|144597807|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3||||0.279|TWO_SIDED|95.0|-0.77|0.22|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing 2 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.22|-0.77|0.279
72534565|NCT01945034|144597807|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3||||0.315|TWO_SIDED|95.0|-0.9|0.29|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing 2 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.||0.29|-0.90|0.315
72534566|NCT01945034|144597807|SUPERIORITY_OR_OTHER||LS Mean Difference|0.4||||0.203|TWO_SIDED|95.0|-0.19|0.91|||ANOVA|p-value \<=0.05 for treatment effects||At Rest 3 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.91|-0.19|0.203
72534567|NCT01945034|144597807|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3||||0.207|TWO_SIDED|95.0|-0.83|0.18|||ANOVA|p-value \<=0.05 for treatment effects||At Rest 3 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.18|-0.83|0.207
72534568|NCT01945034|144597807|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.7||||0.03|TWO_SIDED|95.0|-1.3|-0.07|||ANOVA|p-value \<=0.05 for treatment effects||At Rest 3 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.||-0.07|-1.30|0.030
72534569|NCT01945034|144597807|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3||||0.372|TWO_SIDED|95.0|-0.32|0.84|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing 3 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.84|-0.32|0.372
72572687|NCT03056157|144672787|SUPERIORITY||Slope|-0.6||||0.37|TWO_SIDED|95.0|-1.93|0.73|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for QDS scores, t(316) = -0.89, d = 0.12.||0.73|-1.93|.37
72408140|NCT05421078|144324735|SUPERIORITY||Least Squares (LS) Means|-36.12|STANDARD_ERROR_OF_MEAN|5.323|<|0.0001|TWO_SIDED|95.0|-46.68|-25.55||p value is calculated|Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-25.55|-46.68|<.0001
72534570|NCT01945034|144597807|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2||||0.532|TWO_SIDED|95.0|-0.7|0.36|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing 3 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.36|-0.70|0.532
72534571|NCT01945034|144597807|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4||||0.189|TWO_SIDED|95.0|-1.08|0.21|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing 3 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.||0.21|-1.08|0.189
72534572|NCT01945034|144597807|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3||||0.264|TWO_SIDED|95.0|-0.24|0.87|||ANOVA|p-value \<=0.05 for treatment effects||At Rest 4 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.87|-0.24|0.264
72534573|NCT01945034|144597807|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3||||0.26|TWO_SIDED|95.0|-0.81|0.22|||ANOVA|p-value \<=0.05 for treatment effects||At Rest 4 hour Day 1:The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.22|-0.81|0.260
72572688|NCT03056157|144672787|SUPERIORITY||Slope|-0.04||||0.94|TWO_SIDED|95.0|-1.0|0.92|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for QDS scores, t(114) = -0.08, d = 0.02.||0.92|-1.00|0.94
72572689|NCT03056157|144672787|SUPERIORITY||Slope|0.57||||0.23|TWO_SIDED|95.0|-0.35|1.48|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for QDS scores, t(114) = 1.21, d = 0.23.||1.48|-0.35|0.23
72572690|NCT03056157|144672788|SUPERIORITY||Slope|3.98||||0.01|TWO_SIDED|95.0|0.83|7.13|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for SCS scores, t(316) = 2.49, d = 0.28.||7.13|0.83|0.01
72572691|NCT03056157|144672788|SUPERIORITY||Slope|4.84|||<|0.001|TWO_SIDED|95.0|2.55|7.13|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for SCS scores, t(114) = 4.16, d = 0.78.||7.13|2.55|<0.001
72408141|NCT05421078|144324736|SUPERIORITY||Least Squares (LS) Means|-25.84|STANDARD_ERROR_OF_MEAN|5.387|<|0.0001|TWO_SIDED|95.0|-36.53|-15.14||p value is calculated|Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-15.14|-36.53|<.0001
72408142|NCT05421078|144324736|SUPERIORITY||Least Squares (LS) Means|-33.34|STANDARD_ERROR_OF_MEAN|5.378|<|0.0001|TWO_SIDED|95.0|-44.01|-22.66||p value is calculated|Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-22.66|-44.01|<.0001
72572692|NCT03056157|144672788|SUPERIORITY||Slope|0.85||||0.44|TWO_SIDED|95.0|-1.31|3.02|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for SCS scores, t(114) = 0.78, d = 0.15.||3.02|-1.31|0.44
72572693|NCT03056157|144672788|SUPERIORITY||Slope|0.21||||0.88|TWO_SIDED|95.0|-2.32|2.75|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for SCS scores, t(316) = 0.17, d = 0.02.||2.75|-2.32|0.88
72572694|NCT03056157|144672788|SUPERIORITY||Slope|0.55||||0.55|TWO_SIDED|95.0|-1.27|2.37|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for SCS scores, t(316) = 0.60, d = 0.07.||2.37|-1.27|0.55
72626492|NCT00862940|144781860|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.04|STANDARD_ERROR_OF_MEAN|1.3||0.9754|TWO_SIDED|95.0|-2.6|2.52|||Mixed Models Analysis|||Linear mixed model relating direct change in brain volume (BBSI) to time and its interaction with treatment group. This model additionally includes a time-by-AChEI group interaction as a fixed effect.||2.52|-2.60|0.9754
72408143|NCT05421078|144324736|SUPERIORITY||Least Squares (LS) Means|-36.12|STANDARD_ERROR_OF_MEAN|5.323|<|0.0001|TWO_SIDED|95.0|-46.68|-25.55||p value is calculated|Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-25.55|-46.68|<.0001
72534574|NCT01945034|144597807|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.6||||0.054|TWO_SIDED|95.0|-1.23|0.01|||ANOVA|p-value \<=0.05 for treatment effects||At Rest 4 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.||0.01|-1.23|0.054
72534575|NCT01945034|144597807|SUPERIORITY_OR_OTHER||LS Mean Difference|0.2||||0.456|TWO_SIDED|95.0|-0.37|0.81|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing 4 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.81|-0.37|0.456
72534576|NCT01945034|144597807|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1||||0.639|TWO_SIDED|95.0|-0.42|0.68|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing 4 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.68|-0.42|0.639
72534577|NCT01945034|144597807|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1||||0.78|TWO_SIDED|95.0|-0.75|0.57|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing 4 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.||0.57|-0.75|0.780
72534578|NCT01945034|144597807|SUPERIORITY_OR_OTHER||LS Mean Difference|0.5||||0.071|TWO_SIDED|95.0|-0.04|1.07|||ANOVA|p-value \<=0.05 for treatment effects||At Rest 5 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||1.07|-0.04|0.071
72534579|NCT01945034|144597807|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2||||0.468|TWO_SIDED|95.0|-0.7|0.32|||ANOVA|p-value \<=0.05 for treatment effects||At Rest 5 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.32|-0.70|0.468
72626493|NCT00862940|144781861|SUPERIORITY_OR_OTHER||Adjusted mean difference|-3.5|STANDARD_ERROR_OF_MEAN|17.52||0.842|TWO_SIDED|95.0|-38.04|31.04|||MMRM|||Mixed model repeated measurements (MMRM) with unstructured covariance including time, time-by-treatment, visit, pre-treatment HCV, and AChEI group.||31.04|-38.04|0.842
72534580|NCT01945034|144597807|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.7||||0.027|TWO_SIDED|95.0|-1.33|-0.08|||ANOVA|p-value \<=0.05 for treatment effects||At Rest 5 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.||-0.08|-1.33|0.027
72534581|NCT01945034|144597807|SUPERIORITY_OR_OTHER||LS Mean Difference|0.5||||0.107|TWO_SIDED|95.0|-0.11|1.09|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing 5 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||1.09|-0.11|0.107
72534582|NCT01945034|144597807|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0||||0.947|TWO_SIDED|95.0|-0.57|0.53|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing 5 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.53|-0.57|0.947
72534583|NCT01945034|144597807|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.5||||0.134|TWO_SIDED|95.0|-1.18|0.16|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing 5 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.||0.16|-1.18|0.134
72626494|NCT00862940|144781862|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.68|STANDARD_ERROR_OF_MEAN|0.79||0.034|TWO_SIDED|95.0|0.13|3.23||The p-value represents the difference from placebo for COWAT at Week 52 (MMRM).|MMRM|||||3.23|0.13|0.034
72572695|NCT03056157|144672788|SUPERIORITY||Slope|0.38||||0.7|TWO_SIDED|95.0|-1.42|2.1|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for SCS scores, t(316) = 0.38, d = 0.04.||2.10|-1.42|0.70
72572696|NCT03056157|144672789|SUPERIORITY||Slope|-0.04||||0.8|TWO_SIDED|95.0|-0.32|0.25|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for SCBSC scores, t(318) = -0.25, d = 0.03.||0.25|-0.32|0.80
72572697|NCT03056157|144672789|SUPERIORITY||Slope|0.04||||0.57|TWO_SIDED|95.0|-0.09|0.16|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for SCBSC scores, t(115) = 0.57, d = 0.11.||0.16|-0.09|0.57
72626495|NCT00862940|144781863|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.24|STANDARD_ERROR_OF_MEAN|0.46||0.602|TWO_SIDED|95.0|-0.67|1.15||The p-value represents the difference from placebo for MMSE at Week 52 (MMRM).|MMRM|||||1.15|-0.67|0.602
72626496|NCT00253422|144781910|SUPERIORITY||Hazard Ratio (HR)|1.03||||0.76|TWO_SIDED|95.0|0.86|1.24|||Log Rank|||||1.24|0.86|0.76
72626497|NCT00253422|144781910|SUPERIORITY||Hazard Ratio (HR)|1.0||||1|TWO_SIDED|95.0|0.83|1.2|||Log Rank|||||1.20|0.83|1.00
72626498|NCT00253422|144781911|SUPERIORITY|||||||0.99|||||||Chi-squared|||||||0.99
72626499|NCT00253422|144781911|SUPERIORITY|||||||0.12|||||||Chi-squared|||||||0.12
72626500|NCT00253422|144781913|SUPERIORITY|||||||0.33|||||||Chi-squared|||||||0.33
72626501|NCT00253422|144781913|SUPERIORITY|||||||0.94|||||||Chi-squared|||||||0.94
72626502|NCT00253422|144781915|SUPERIORITY||Hazard Ratio (HR)|1.01||||0.95|TWO_SIDED|95.0|0.84|1.21|||Log Rank||HR less than 1 favour Faslodex + Arimidex|||1.21|0.84|0.95
72626503|NCT00253422|144781915|SUPERIORITY||Hazard Ratio (HR)|1.04||||0.66|TWO_SIDED|95.0|0.87|1.25|||Log Rank||HR less than 1 favours Faslodex + placebo|||1.25|0.87|0.66
72408144|NCT05421078|144324737|SUPERIORITY||Least Squares (LS) Means|-27.2|STANDARD_ERROR_OF_MEAN|5.626|<|0.0001|TWO_SIDED|95.0|-38.37|-16.04||p value is calculated|ANCOVA|||||-16.04|-38.37|<.0001
72408145|NCT05421078|144324737|SUPERIORITY||Least Squares (LS) Means|-31.23|STANDARD_ERROR_OF_MEAN|5.609|<|0.0001|TWO_SIDED|95.0|-42.36|-20.1||p value is calculated|ANCOVA|||||-20.10|-42.36|<.0001
72408146|NCT05421078|144324737|SUPERIORITY||Least Squares (LS) Means|-36.81|STANDARD_ERROR_OF_MEAN|5.55|<|0.0001|TWO_SIDED|95.0|-47.83|-25.8||p value is calculated|ANCOVA|||||-25.80|-47.83|<.0001
72534584|NCT01945034|144597807|SUPERIORITY_OR_OTHER||LS Mean Difference|0.7||||0.017|TWO_SIDED|95.0|0.12|1.23|||ANOVA|p-value \<=0.05 for treatment effects||At Rest 6 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||1.23|0.12|0.017
72534585|NCT01945034|144597807|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1||||0.715|TWO_SIDED|95.0|-0.6|0.41|||ANOVA|p-value \<=0.05 for treatment effects||At Rest 6 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.41|-0.60|0.715
72534586|NCT01945034|144597807|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.8||||0.015|TWO_SIDED|95.0|-1.39|-0.15|||ANOVA|p-value \<=0.05 for treatment effects||At Rest 6 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.||-0.15|-1.39|0.015
72534587|NCT01945034|144597807|SUPERIORITY_OR_OTHER||LS Mean Difference|0.7||||0.027|TWO_SIDED|95.0|0.07|1.23|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing 6 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||1.23|0.07|0.027
72534588|NCT01945034|144597807|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1||||0.66|TWO_SIDED|95.0|-0.42|0.65|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing 6 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.65|-0.42|0.660
72534589|NCT01945034|144597807|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.5||||0.107|TWO_SIDED|95.0|-1.18|0.11|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing 6 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.||0.11|-1.18|0.107
72534590|NCT01945034|144597807|SUPERIORITY_OR_OTHER||LS Mean Difference|0.6||||0.02|TWO_SIDED|95.0|0.1|1.13|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 1(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||1.13|0.10|0.020
72534591|NCT01945034|144597807|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1||||0.749|TWO_SIDED|95.0|-0.55|0.4|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 1(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.40|-0.55|0.749
72626504|NCT00253422|144781916|SUPERIORITY||Hazard Ratio (HR)|0.99||||0.91|TWO_SIDED|95.0|0.82|1.19|||Log Rank||HR less than 1 favours Faslodex + Arimidex|||1.19|0.82|0.91
72626505|NCT00253422|144781916|SUPERIORITY||Hazard Ratio (HR)|1.1||||0.31|TWO_SIDED|95.0|0.91|1.32|||Log Rank||HR less than 1 favours Faslodex + Placebo|||1.32|0.91|0.31
72626506|NCT04533646|144781920|OTHER||Mean Difference (Net)|1.1|||<|0.01|TWO_SIDED||||||Means testing||||comparison of means test was performed|||<0.01
72626507|NCT00285779|144781928|SUPERIORITY_OR_OTHER|||||||0.0978|TWO_SIDED||||||Fisher Exact|||||||0.0978
72626508|NCT00285779|144781929|OTHER||||||>|0.9999|||||||Fisher Exact|||||||>0.9999
72626509|NCT00285779|144781930|OTHER|||||||0.031|||||||Wilcoxon Paired|||Week 12 versus baseline||||0.031
72626510|NCT00285779|144781930|OTHER|||||||0.34|||||||Wilcoxon Paired|||Week 12 versus baseline||||0.34
72626511|NCT00285779|144781930|OTHER|||||||0.13|||||||Wilcoxon Paired|||Week 24 versus baseline||||0.13
72626512|NCT00285779|144781930|OTHER|||||||0.22|||||||Wilcoxon Paired|||Week 24 versus baseline||||0.22
72626513|NCT00285779|144781931|OTHER||||||>|0.9999|||||||Wilcoxon Paired|||Week 12 versus baseline||||>0.9999
72626514|NCT00285779|144781931|OTHER||||||>|0.9999|||||||Wilcoxon Paired|||Week 24 versus baseline||||>0.9999
72626515|NCT00285779|144781932|OTHER|||||||0.25|||||||Wilcoxon Paired|||Week 12 versus baseline||||0.25
72626516|NCT00285779|144781932|OTHER||||||>|0.9999|||||||Wilcoxon Paired|||Week 12 versus baseline||||>0.9999
72408147|NCT05421078|144324738|SUPERIORITY||Least Squares (LS) Means|-27.2|STANDARD_ERROR_OF_MEAN|5.626|<|0.0001|TWO_SIDED|95.0|-38.37|-16.04||p value is calculated|ANCOVA|||||-16.04|-38.37|<.0001
72408148|NCT05421078|144324738|SUPERIORITY||Least Squares (LS) Means|-31.23|STANDARD_ERROR_OF_MEAN|5.609|<|0.0001|TWO_SIDED|95.0|-42.36|-20.1||p value is calculated|ANCOVA|||||-20.10|-42.36|<.0001
72408149|NCT05421078|144324738|SUPERIORITY||Least Squares (LS) Means|-36.81|STANDARD_ERROR_OF_MEAN|5.55|<|0.0001|TWO_SIDED|95.0|-47.83|-25.8||p value is calculated|ANCOVA|||||-25.80|-47.83|<.0001
72408150|NCT05421078|144324739|SUPERIORITY||Least Squares (LS) Means|-27.2|STANDARD_ERROR_OF_MEAN|5.626|<|0.0001|TWO_SIDED|95.0|-38.37|-16.04||p value is calculated|ANCOVA|||||-16.04|-38.37|<.0001
72408151|NCT05421078|144324739|SUPERIORITY||Least Squares (LS) Means|-31.23|STANDARD_ERROR_OF_MEAN|5.609|<|0.0001|TWO_SIDED|95.0|-42.36|-20.1||p value is calculated|ANCOVA|||||-20.10|-42.36|<.0001
72408152|NCT05421078|144324739|SUPERIORITY||Least Squares (LS) Means|-36.81|STANDARD_ERROR_OF_MEAN|5.55|<|0.0001|TWO_SIDED|95.0|-47.83|-25.8||p value is calculated|ANCOVA|||||-25.80|-47.83|<.0001
72534592|NCT01945034|144597807|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.7||||0.019|TWO_SIDED|95.0|-1.27|-0.12|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 1(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.||-0.12|-1.27|0.019
72534593|NCT01945034|144597807|SUPERIORITY_OR_OTHER||LS Mean Difference|0.4||||0.163|TWO_SIDED|95.0|-0.16|0.96|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 1(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.96|-0.16|0.163
72534594|NCT01945034|144597807|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1||||0.727|TWO_SIDED|95.0|-0.43|0.61|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 1(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.61|-0.43|0.727
72534595|NCT01945034|144597807|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3||||0.336|TWO_SIDED|95.0|-0.94|0.32|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 1(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.||0.32|-0.94|0.336
72534596|NCT01945034|144597807|SUPERIORITY_OR_OTHER||LS Mean Difference|0.4||||0.174|TWO_SIDED|95.0|-0.16|0.87|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 2(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.87|-0.16|0.174
72534597|NCT01945034|144597807|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3||||0.277|TWO_SIDED|95.0|-0.73|0.21|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 2(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.21|-0.73|0.277
72534598|NCT01945034|144597807|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.6||||0.035|TWO_SIDED|95.0|-1.19|-0.04|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 2(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.||-0.04|-1.19|0.035
72534599|NCT01945034|144597807|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1||||0.858|TWO_SIDED|95.0|-0.5|0.6|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 2(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.60|-0.50|0.858
72534600|NCT01945034|144597807|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1||||0.724|TWO_SIDED|95.0|-0.6|0.42|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 2(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.42|-0.60|0.724
72572698|NCT03056157|144672789|SUPERIORITY||Slope|-0.01||||0.82|TWO_SIDED|95.0|-0.14|0.11|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for SCBSC scores, t(115) = -0.23, d = 0.04.||0.11|-0.14|0.82
72572699|NCT03056157|144672789|SUPERIORITY||Slope|0.05||||0.57|TWO_SIDED|95.0|-0.13|0.23|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for SCBSC scores, t(320) = 0.57, d = 0.06.||0.23|-0.13|0.57
72626517|NCT00285779|144781932|OTHER|||||||0.063|||||||Wilcoxon Paired|||Week 24 versus baseline||||0.063
72626518|NCT00285779|144781932|OTHER||||||>|0.9999|||||||Wilcoxon Paired|||Week 24 versus baseline||||>0.9999
72626519|NCT00285779|144781933|OTHER|||||||0.063|||||||Wilcoxon Paired|||Week 12 versus baseline||||0.063
72626520|NCT00285779|144781933|OTHER|||||||0.25|||||||Wilcoxon Paired|||Week 12 versus baseline||||0.25
72572700|NCT03056157|144672790|SUPERIORITY||Slope|3.91||||0.002|TWO_SIDED|95.0|1.48|6.35|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for VLQ scores, t(408) = 3.16, d = 0.32.||6.35|1.48|0.002
72572701|NCT03056157|144672790|SUPERIORITY||Slope|4.16|||<|0.001|TWO_SIDED|95.0|2.41|5.92|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for VLQ scores, t(121) = 4.66, d = 0.85.||5.92|2.41|<0.001
72572702|NCT03056157|144672790|SUPERIORITY||Slope|0.25||||0.78|TWO_SIDED|95.0|-1.44|1.94|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for VLQ scores, t(121) = 0.63, d = 0.11.||1.94|-1.44|0.78
72572703|NCT03056157|144672790|SUPERIORITY||Slope|-0.05||||0.73|TWO_SIDED|95.0|-0.34|0.24|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for VLQ scores, t(408) = -0.34, d = 0.01.||0.24|-0.34|0.73
72408153|NCT05421078|144324740|SUPERIORITY||Least Squares (LS) Means|-19.0|STANDARD_ERROR_OF_MEAN|3.439|<|0.0001|TWO_SIDED|95.0|-25.83|-12.18||p value is calculated|Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-12.18|-25.83|<.0001
72408154|NCT05421078|144324740|SUPERIORITY||Least Squares (LS) Means|-22.45|STANDARD_ERROR_OF_MEAN|3.441|<|0.0001|TWO_SIDED|95.0|-29.28|-15.62||p value is calculated|Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-15.62|-29.28|<.0001
72572704|NCT03056157|144672790|SUPERIORITY||Slope|0.06||||0.58|TWO_SIDED|95.0|-0.15|0.27|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for VLQ scores, t(408) = 0.56, d = 0.06.||0.27|-0.15|0.58
72572705|NCT03056157|144672790|SUPERIORITY||Slope|0.11||||0.28|TWO_SIDED|95.0|-0.1|0.31|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for VLQ scores, t(408) = 1.07, d = 0.11.||0.31|-0.10|0.28
72626521|NCT00285779|144781933|OTHER|||||||0.031|||||||Wilcoxon Paired|||Week 24 versus baseline||||0.031
72626522|NCT00285779|144781933|OTHER|||||||0.32|||||||Wilcoxon Paired|||Week 24 versus baseline||||0.32
72626523|NCT00285779|144781934|OTHER|||||||0.094|||||||Wilcoxon Paired|||Week 12 versus baseline||||0.094
72626524|NCT00285779|144781934|OTHER|||||||0.25|||||||Wilcoxon Paired|||Week 12 versus baseline||||0.25
72626525|NCT00285779|144781934|OTHER|||||||0.13|||||||Wilcoxon Paired|||Week 24 versus baseline||||0.13
72408155|NCT05421078|144324740|SUPERIORITY||Least Squares (LS) Means|-24.86|STANDARD_ERROR_OF_MEAN|3.406|<|0.0001|TWO_SIDED|95.0|-31.62|-18.1||p value is calculated|Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-18.10|-31.62|<.0001
72408156|NCT05421078|144324741|SUPERIORITY||Least Squares (LS) Means|-19.0|STANDARD_ERROR_OF_MEAN|3.439|<|0.0001|TWO_SIDED|95.0|-25.83|-12.18||p value is calculated|Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-12.18|-25.83|<.0001
72408157|NCT05421078|144324741|SUPERIORITY||Least Squares (LS) Means|-22.45|STANDARD_ERROR_OF_MEAN|3.441|<|0.0001|TWO_SIDED|95.0|-29.28|-15.62||p value is calculated|Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-15.62|-29.28|<.0001
72408158|NCT05421078|144324741|SUPERIORITY||Least Squares (LS) Means|-24.86|STANDARD_ERROR_OF_MEAN|3.406|<|0.0001|TWO_SIDED|95.0|-31.62|-18.1||p value is calculated|Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-18.10|-31.62|<.0001
72534601|NCT01945034|144597807|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1||||0.651|TWO_SIDED|95.0|-0.76|0.48|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 2(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.||0.48|-0.76|0.651
72534602|NCT01945034|144597807|SUPERIORITY_OR_OTHER||LS Mean Difference|0.5||||0.059|TWO_SIDED|95.0|-0.02|1.05|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 2 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||1.05|-0.02|0.059
72534603|NCT01945034|144597807|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1||||0.766|TWO_SIDED|95.0|-0.57|0.42|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 2 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.42|-0.57|0.766
72534604|NCT01945034|144597807|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.6||||0.053|TWO_SIDED|95.0|-1.19|0.01|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 2 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.||0.01|-1.19|0.053
72534605|NCT01945034|144597807|SUPERIORITY_OR_OTHER||LS Mean Difference|0.4||||0.212|TWO_SIDED|95.0|-0.21|0.92|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 2 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.92|-0.21|0.212
72534606|NCT01945034|144597807|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0||||0.911|TWO_SIDED|95.0|-0.49|0.55|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 2 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.55|-0.49|0.911
72534607|NCT01945034|144597807|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3||||0.305|TWO_SIDED|95.0|-0.96|0.3|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 2 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.||0.30|-0.96|0.305
72534608|NCT01945034|144597807|SUPERIORITY_OR_OTHER||LS Mean Difference|0.5||||0.075|TWO_SIDED|95.0|-0.05|1.02|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 2(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||1.02|-0.05|0.075
72534609|NCT01945034|144597807|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1||||0.684|TWO_SIDED|95.0|-0.39|0.6|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 2(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.60|-0.39|0.684
72534610|NCT01945034|144597807|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4||||0.208|TWO_SIDED|95.0|-0.98|0.21|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 2(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.||0.21|-0.98|0.208
72534611|NCT01945034|144597807|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3||||0.304|TWO_SIDED|95.0|-0.27|0.85|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 2(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.85|-0.27|0.304
72534612|NCT01945034|144597807|SUPERIORITY_OR_OTHER||LS Mean Difference|0.2||||0.356|TWO_SIDED|95.0|-0.27|0.76|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 2(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.76|-0.27|0.356
72626526|NCT00285779|144781934|OTHER|||||||0.13|||||||Wilcoxon Paired|||Week 24 versus baseline||||0.13
72626527|NCT00285779|144781935|OTHER|||||||0.63|||||||Wilcoxon Paired|||Week 12 versus baseline||||0.63
72626528|NCT00285779|144781935|OTHER|||||||0.38|||||||Wilcoxon Paired|||Week 12 versus baseline||||0.38
72408159|NCT05421078|144324742|SUPERIORITY||Least Squares (LS) Means|-19.0|STANDARD_ERROR_OF_MEAN|3.439|<|0.0001|TWO_SIDED|95.0|-25.83|-12.18||p value is calculated|Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-12.18|-25.83|<.0001
72408160|NCT05421078|144324742|SUPERIORITY||Least Squares (LS) Means|-22.45|STANDARD_ERROR_OF_MEAN|3.441|<|0.0001|TWO_SIDED|95.0|-29.28|-15.62||p value is calculated|Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-15.62|-29.28|<.0001
72408161|NCT05421078|144324742|SUPERIORITY||Least Squares (LS) Means|-24.86|STANDARD_ERROR_OF_MEAN|3.406|<|0.0001|TWO_SIDED|95.0|-31.62|-18.1||p value is calculated|Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-18.10|-31.62|<.0001
72408162|NCT05421078|144324743|SUPERIORITY||Least Squares (LS) Means|-23.94|STANDARD_ERROR_OF_MEAN|4.85|<|0.0001|TWO_SIDED|95.0|-33.56|-14.31||p value is calculated|Mixed Models Analysis|||||-14.31|-33.56|<.0001
72408163|NCT05421078|144324743|SUPERIORITY||Least Squares (LS) Means|-28.39|STANDARD_ERROR_OF_MEAN|4.849|<|0.0001|TWO_SIDED|95.0|-38.01|-18.76||p value is calculated|Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-18.76|-38.01|<.0001
72408164|NCT05421078|144324743|SUPERIORITY||Least Squares (LS) Means|-28.55|STANDARD_ERROR_OF_MEAN|4.801|<|0.0001|TWO_SIDED|95.0|-38.08|-19.03||p value is calculated|Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-19.03|-38.08|<.0001
72408165|NCT05421078|144324744|SUPERIORITY||Least Squares (LS) Means|-23.94|STANDARD_ERROR_OF_MEAN|4.85|<|0.0001|TWO_SIDED|95.0|-33.56|-14.31||p value is calculated|Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-14.31|-33.56|<.0001
72408166|NCT05421078|144324744|SUPERIORITY||Least Squares (LS) Means|-28.39|STANDARD_ERROR_OF_MEAN|4.849|<|0.0001|TWO_SIDED|95.0|-38.01|-18.76||p value is calculated|Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-18.76|-38.01|<.0001
72408167|NCT05421078|144324744|SUPERIORITY||Least Squares (LS) Means|-28.55|STANDARD_ERROR_OF_MEAN|4.801|<|0.0001|TWO_SIDED|95.0|-38.08|-19.03||p value is calculated|Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-19.03|-38.08|<.0001
72408168|NCT05421078|144324745|SUPERIORITY||Least Squares (LS) Means|-23.94|STANDARD_ERROR_OF_MEAN|4.85|<|0.0001|TWO_SIDED|95.0|-33.56|-14.31||p value is calculated|Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-14.31|-33.56|<.0001
72408169|NCT05421078|144324745|SUPERIORITY||Least Squares (LS) Means|-28.39|STANDARD_ERROR_OF_MEAN|4.849|<|0.0001|TWO_SIDED|95.0|-38.01|-18.76||p value is calculated|Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-18.76|-38.01|<.0001
72408170|NCT05421078|144324745|SUPERIORITY||Least Squares (LS) Means|-28.55|STANDARD_ERROR_OF_MEAN|4.801|<|0.0001|TWO_SIDED|95.0|-38.08|-19.03||p value is calculated|Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-19.03|-38.08|<.0001
72534613|NCT01945034|144597807|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0||||0.876|TWO_SIDED|95.0|-0.67|0.58|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 2(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.||0.58|-0.67|0.876
72534614|NCT01945034|144597807|SUPERIORITY_OR_OTHER||LS Mean Difference|0.6||||0.02|TWO_SIDED|95.0|0.1|1.15|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 3(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||1.15|0.10|0.020
72534615|NCT01945034|144597807|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0||||0.94|TWO_SIDED|95.0|-0.5|0.47|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 3(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.47|-0.50|0.940
72408171|NCT05421078|144324746|SUPERIORITY||Least Squares (LS) Means|133.11|STANDARD_ERROR_OF_MEAN|10.205|<|0.0001|TWO_SIDED|95.0|112.85|153.36||p value is calculated|Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||153.36|112.85|<.0001
72408172|NCT05421078|144324746|SUPERIORITY||Least Squares (LS) Means|147.41|STANDARD_ERROR_OF_MEAN|10.195|<|0.0001|TWO_SIDED|95.0|127.17|167.64||p value is calculated|Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||167.64|127.17|<.0001
72534616|NCT01945034|144597807|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.6||||0.032|TWO_SIDED|95.0|-1.23|-0.06|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 3(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.||-0.06|-1.23|0.032
72534617|NCT01945034|144597807|SUPERIORITY_OR_OTHER||LS Mean Difference|0.4||||0.206|TWO_SIDED|95.0|-0.21|0.95|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 3(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.95|-0.21|0.206
72534618|NCT01945034|144597807|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3||||0.31|TWO_SIDED|95.0|-0.26|0.81|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 3(AM):The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.81|-0.26|0.310
72534619|NCT01945034|144597807|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1||||0.771|TWO_SIDED|95.0|-0.74|0.55|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 3(AM):The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.||0.55|-0.74|0.771
72534620|NCT01945034|144597807|SUPERIORITY_OR_OTHER||LS Mean difference|0.7||||0.016|TWO_SIDED|95.0|0.13|1.24|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 3(AM + 2 hours): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||1.24|0.13|0.016
72534621|NCT01945034|144597807|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0||||0.905|TWO_SIDED|95.0|-0.48|0.54|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 3(AM + 2 hours): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.54|-0.48|0.905
72534622|NCT01945034|144597807|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.7||||0.039|TWO_SIDED|95.0|-1.28|-0.03|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 3(AM + 2 hours): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.||-0.03|-1.28|0.039
72626529|NCT00285779|144781935|OTHER|||||||0.38|||||||Wilcoxon Paired|||Week 24 versus baseline||||0.38
72534623|NCT01945034|144597807|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3||||0.276|TWO_SIDED|95.0|-0.27|0.93|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 3(AM + 2 hours): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.93|-0.27|0.276
72534624|NCT01945034|144597807|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3||||0.343|TWO_SIDED|95.0|-0.29|0.82|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 3(AM + 2 hours): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.82|-0.29|0.343
72534625|NCT01945034|144597807|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1||||0.849|TWO_SIDED|95.0|-0.73|0.6|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 3(AM + 2 hours): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.||0.60|-0.73|0.849
72534626|NCT01945034|144597807|SUPERIORITY_OR_OTHER||LS Mean Difference|0.7||||0.009|TWO_SIDED|95.0|0.19|1.29|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 3 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||1.29|0.19|0.009
72534627|NCT01945034|144597807|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1||||0.763|TWO_SIDED|95.0|-0.58|0.43|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 3 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.43|-0.58|0.763
72534628|NCT01945034|144597807|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.8||||0.01|TWO_SIDED|95.0|-1.43|-0.2|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 3 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.||-0.20|-1.43|0.010
72534629|NCT01945034|144597807|SUPERIORITY_OR_OTHER||LS Mean Difference|0.5||||0.105|TWO_SIDED|95.0|-0.1|1.09|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 3 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||1.09|-0.10|0.105
72534630|NCT01945034|144597807|SUPERIORITY_OR_OTHER||LS Mean Difference|0.2||||0.533|TWO_SIDED|95.0|-0.38|0.73|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 3 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.73|-0.38|0.533
72534631|NCT01945034|144597807|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3||||0.348|TWO_SIDED|95.0|-0.99|0.35|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 3 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.||0.35|-0.99|0.348
72534632|NCT01945034|144597807|SUPERIORITY_OR_OTHER||LS Mean Difference|0.7||||0.016|TWO_SIDED|95.0|0.13|1.23|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 3(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||1.23|0.13|0.016
72534633|NCT01945034|144597807|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2||||0.483|TWO_SIDED|95.0|-0.69|0.33|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 3(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.33|-0.69|0.483
72534634|NCT01945034|144597807|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.9||||0.006|TWO_SIDED|95.0|-1.47|-0.25|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 3(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.||-0.25|-1.47|0.006
72534635|NCT01945034|144597807|SUPERIORITY_OR_OTHER||LS Mean Difference|0.4||||0.177|TWO_SIDED|95.0|-0.19|1.0|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 3(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||1.00|-0.19|0.177
72534636|NCT01945034|144597807|SUPERIORITY_OR_OTHER||LS Mean Difference|0.2||||0.586|TWO_SIDED|95.0|-0.4|0.7|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 3(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.70|-0.40|0.586
72534637|NCT01945034|144597807|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3||||0.448|TWO_SIDED|95.0|-0.92|0.41|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 3(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.||0.41|-0.92|0.448
72576778|NCT00261443|144680651|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.69||||0.144|TWO_SIDED|95.0|-1.61|0.24||Mean change from baseline: ANOVA model, controlling for treatment, mood stabilizer, index mood episode, and baseline value. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 8 Comparison||0.24|-1.61|0.144
72534638|NCT01945034|144597807|SUPERIORITY_OR_OTHER||LS Mean Difference|0.6||||0.043|TWO_SIDED|95.0|0.02|1.09|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 4(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||1.09|0.02|0.043
72572706|NCT03560986|144672791|SUPERIORITY||Mean Difference (Net)|0.43|STANDARD_ERROR_OF_MEAN|0.372||0.2522|TWO_SIDED|95.0|-0.31|1.17||2-sided p-value for testing superiority of neridronic acid 400 mg compared to placebo.|Mixed Models Analysis|The degrees of freedom of the denominator are estimated using the Kenward-Roger approximation.|The primary endpoint estimate was the least squares mean differences of change from baseline in pain NRS (electronic diary) at Week 12 between neridronate and Placebo.|Mixed-effects model for repeated measures (MMRM) defined with baseline pain intensity as covariate, the factors geographic region, week, treatment and treatment-by-week as fixed effects, and an unstructured covariance matrix to model the covariance structure of the repeated measurements.||1.17|-0.31|0.2522
72408173|NCT05421078|144324746|SUPERIORITY||Least Squares (LS) Means|155.98|STANDARD_ERROR_OF_MEAN|10.1|<|0.0001|TWO_SIDED|95.0|135.93|176.02||p value is calculated|Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||176.02|135.93|<.0001
72408174|NCT05421078|144324747|SUPERIORITY||Least Squares (LS) Means|133.11|STANDARD_ERROR_OF_MEAN|10.205|<|0.0001|TWO_SIDED|95.0|112.85|153.36||p value is calculated|Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||153.36|112.85|<.0001
72534639|NCT01945034|144597807|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1||||0.688|TWO_SIDED|95.0|-0.59|0.39|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 4(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.39|-0.59|0.688
72534640|NCT01945034|144597807|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.7||||0.032|TWO_SIDED|95.0|-1.25|-0.06|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 4(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.||-0.06|-1.25|0.032
72534641|NCT01945034|144597807|SUPERIORITY_OR_OTHER||LS Mean Difference|0.4||||0.179|TWO_SIDED|95.0|-0.19|0.99|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 4(AM):The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.99|-0.19|0.179
72534642|NCT01945034|144597807|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1||||0.609|TWO_SIDED|95.0|-0.4|0.69|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 4(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.69|-0.40|0.609
72534643|NCT01945034|144597807|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3||||0.435|TWO_SIDED|95.0|-0.92|0.4|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 4(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.||0.40|-0.92|0.435
72572707|NCT00593736|144672805|SUPERIORITY_OR_OTHER|||||||0.646||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|Least Squares (LS) means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the analysis of covariance (ANCOVA) model.||||0.646
72572708|NCT00593736|144672805|SUPERIORITY_OR_OTHER|||||||0.084||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.084
72572709|NCT00593736|144672805|SUPERIORITY_OR_OTHER|||||||0.929||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.929
72572710|NCT00593736|144672806|SUPERIORITY_OR_OTHER|||||||0.854||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS Means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.854
72572711|NCT00593736|144672806|SUPERIORITY_OR_OTHER|||||||0.383||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS Means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.383
72572712|NCT00593736|144672806|SUPERIORITY_OR_OTHER|||||||0.883||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS Means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.883
72408175|NCT05421078|144324747|SUPERIORITY||Least Squares (LS) Means|147.41|STANDARD_ERROR_OF_MEAN|10.195|<|0.0001|TWO_SIDED|95.0|127.17|167.64||p value is calculated|Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||167.64|127.17|<.0001
72534644|NCT01945034|144597807|SUPERIORITY_OR_OTHER||LS Mean Difference|0.7||||0.023|TWO_SIDED|95.0|0.1|1.26|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 4 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||1.26|0.10|0.023
72572713|NCT00593736|144672807|SUPERIORITY_OR_OTHER|||||||0.365||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS Means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.365
72572714|NCT00593736|144672807|SUPERIORITY_OR_OTHER|||||||0.121||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.121
72572715|NCT00593736|144672807|SUPERIORITY_OR_OTHER|||||||0.269||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.269
72534645|NCT01945034|144597807|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0||||0.987|TWO_SIDED|95.0|-0.54|0.53|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 4 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.53|-0.54|0.987
72534646|NCT01945034|144597807|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.7||||0.04|TWO_SIDED|95.0|-1.33|-0.03|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 4 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.||-0.03|-1.33|0.040
72534647|NCT01945034|144597807|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3||||0.319|TWO_SIDED|95.0|-0.31|0.94|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 4 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.94|-0.31|0.319
72534648|NCT01945034|144597807|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1||||0.712|TWO_SIDED|95.0|-0.47|0.69|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 4 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.69|-0.47|0.712
72534649|NCT01945034|144597807|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2||||0.557|TWO_SIDED|95.0|-0.91|0.49|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 4 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.||0.49|-0.91|0.557
72534650|NCT01945034|144597807|SUPERIORITY_OR_OTHER||LS Mean Difference|0.7||||0.015|TWO_SIDED|95.0|0.14|1.28|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 4(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||1.28|0.14|0.015
72534651|NCT01945034|144597807|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3||||0.326|TWO_SIDED|95.0|-0.26|0.79|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 4(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.79|-0.26|0.326
72534652|NCT01945034|144597807|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4||||0.167|TWO_SIDED|95.0|-1.08|0.19|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 4(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.||0.19|-1.08|0.167
72534653|NCT01945034|144597807|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3||||0.35|TWO_SIDED|95.0|-0.33|0.93|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 4(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.93|-0.33|0.350
72534654|NCT01945034|144597807|SUPERIORITY_OR_OTHER||LS Mean Difference|0.4||||0.235|TWO_SIDED|95.0|-0.23|0.93|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 4(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.93|-0.23|0.235
72534655|NCT01945034|144597807|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1||||0.881|TWO_SIDED|95.0|-0.65|0.76|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 4(PM):The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.||0.76|-0.65|0.881
72534656|NCT01945034|144597807|SUPERIORITY_OR_OTHER||LS Mean Difference|0.6||||0.036|TWO_SIDED|95.0|0.04|1.16|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 5(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||1.16|0.04|0.036
72534657|NCT01945034|144597807|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1||||0.656|TWO_SIDED|95.0|-0.4|0.63|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 5(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.63|-0.40|0.656
72534658|NCT01945034|144597807|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.5||||0.13|TWO_SIDED|95.0|-1.11|0.14|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 5(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.||0.14|-1.11|0.130
72534659|NCT01945034|144597807|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3||||0.304|TWO_SIDED|95.0|-0.3|0.95|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 5(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.95|-0.30|0.304
72534660|NCT01945034|144597807|SUPERIORITY_OR_OTHER||LS Mean Difference|0.2||||0.491|TWO_SIDED|95.0|-0.37|0.78|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 5(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.||0.78|-0.37|0.491
72534661|NCT01945034|144597807|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1||||0.726|TWO_SIDED|95.0|-0.82|0.57|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 5(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.||0.57|-0.82|0.726
72572716|NCT00593736|144672808|SUPERIORITY_OR_OTHER|||||||0.92||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.920
72534662|NCT01945034|144597807|SUPERIORITY_OR_OTHER||LS Mean Difference|0.6||||0.029|TWO_SIDED|95.0|0.07|1.23|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 5 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||1.23|0.07|0.029
72534663|NCT01945034|144597807|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1||||0.585|TWO_SIDED|95.0|-0.39|0.68|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 5 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.68|-0.39|0.585
72534664|NCT01945034|144597807|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.5||||0.131|TWO_SIDED|95.0|-1.15|0.15|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 5 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.||0.15|-1.15|0.131
72534665|NCT01945034|144597807|SUPERIORITY_OR_OTHER||LS Mean Difference|0.4||||0.215|TWO_SIDED|95.0|-0.24|1.04|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 5 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||1.04|-0.24|0.215
72534666|NCT01945034|144597807|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3||||0.244|TWO_SIDED|95.0|-0.24|0.94|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 5 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.94|-0.24|0.244
72534667|NCT01945034|144597807|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1||||0.885|TWO_SIDED|95.0|-0.76|0.66|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 5 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.||0.66|-0.76|0.885
72534668|NCT01945034|144597807|SUPERIORITY_OR_OTHER||LS Mean Difference|0.5||||0.067|TWO_SIDED|95.0|-0.04|1.13|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 5(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||1.13|-0.04|0.067
72534669|NCT01945034|144597807|SUPERIORITY_OR_OTHER||LS Mean Difference|0.2||||0.5|TWO_SIDED|95.0|-0.35|0.73|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 5(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.73|-0.35|0.500
72534670|NCT01945034|144597807|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4||||0.276|TWO_SIDED|95.0|-1.02|0.29|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 5(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.||0.29|-1.02|0.276
72534671|NCT01945034|144597807|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3||||0.413|TWO_SIDED|95.0|-0.38|0.92|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 5(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.92|-0.38|0.413
72534672|NCT01945034|144597807|SUPERIORITY_OR_OTHER||LS Mean Difference|0.2||||0.448|TWO_SIDED|95.0|-0.37|0.83|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 5(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.83|-0.37|0.448
72534673|NCT01945034|144597807|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0||||0.917|TWO_SIDED|95.0|-0.76|0.69|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 5(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.||0.69|-0.76|0.917
72534674|NCT01945034|144597807|SUPERIORITY_OR_OTHER||LS Mean Difference|0.4||||0.132|TWO_SIDED|95.0|-0.13|1.03|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 6(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||1.03|-0.13|0.132
72534675|NCT01945034|144597807|SUPERIORITY_OR_OTHER||LS Mean Difference|0.2||||0.505|TWO_SIDED|95.0|-0.35|0.72|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 6(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.72|-0.35|0.505
72534676|NCT01945034|144597807|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3||||0.422|TWO_SIDED|95.0|-0.92|0.38|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 6(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.||0.38|-0.92|0.422
72534677|NCT01945034|144597807|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1||||0.747|TWO_SIDED|95.0|-0.54|0.76|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 6(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.76|-0.54|0.747
72572717|NCT00593736|144672808|SUPERIORITY_OR_OTHER|||||||0.382||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.382
72626530|NCT00285779|144781935|OTHER|||||||0.5|||||||Wilcoxon Paired|||Week 24 versus baseline||||0.50
72626531|NCT00285779|144781936|OTHER|||||||0.031|||||||Wilcoxon Paired|||Week 12 versus baseline||||0.031
72626532|NCT00285779|144781936|OTHER|||||||0.094|||||||Wilcoxon Paired|||Week 12 versus baseline||||0.094
72534678|NCT01945034|144597807|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3||||0.386|TWO_SIDED|95.0|-0.34|0.87|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 6(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.87|-0.34|0.386
72534679|NCT01945034|144597807|SUPERIORITY_OR_OTHER||LS Mean Difference|0.2||||0.668|TWO_SIDED|95.0|-0.57|0.89|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 6(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.||0.89|-0.57|0.668
72534680|NCT01945034|144597807|SUPERIORITY_OR_OTHER||LS Mean Difference|0.5||||0.099|TWO_SIDED|95.0|-0.09|1.08|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 6 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||1.08|-0.09|0.099
72534681|NCT01945034|144597807|SUPERIORITY_OR_OTHER||LS Mean Difference|0.2||||0.365|TWO_SIDED|95.0|-0.29|0.79|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 6 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.79|-0.29|0.365
72534682|NCT01945034|144597807|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2||||0.463|TWO_SIDED|95.0|-0.9|0.41|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 6 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.||0.41|-0.90|0.463
72534683|NCT01945034|144597807|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1||||0.845|TWO_SIDED|95.0|-0.6|0.73|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 6 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.73|-0.60|0.845
72534684|NCT01945034|144597807|SUPERIORITY_OR_OTHER||LS Mean Difference|0.4||||0.199|TWO_SIDED|95.0|-0.21|1.02|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 6 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||1.02|-0.21|0.199
72534685|NCT01945034|144597807|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3||||0.375|TWO_SIDED|95.0|-0.41|1.08|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 6 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.||1.08|-0.41|0.375
72572718|NCT00593736|144672808|SUPERIORITY_OR_OTHER|||||||0.439||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.439
72534686|NCT01945034|144597807|SUPERIORITY_OR_OTHER||LS Mean Difference|0.7||||0.028|TWO_SIDED|95.0|0.07|1.27|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 6(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||1.27|0.07|0.028
72534687|NCT01945034|144597807|SUPERIORITY_OR_OTHER||LS Mean Difference|0.4||||0.188|TWO_SIDED|95.0|-0.18|0.92|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 6(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.92|-0.18|0.188
72626533|NCT00285779|144781936|OTHER|||||||0.039|||||||Wilcoxon Paired|||Week 24 versus baseline||||0.039
72626534|NCT00285779|144781936|OTHER|||||||0.19|||||||Wilcoxon Paired|||Week 24 versus baseline||||0.19
72626535|NCT00285779|144781937|OTHER|||||||0.26|||||||Paired t test|||Week 12 versus baseline||||0.26
72626536|NCT00285779|144781937|OTHER|||||||0.55|||||||Paired t test|||Week 12 versus baseline||||0.55
72408176|NCT05421078|144324747|SUPERIORITY||Least Squares (LS) Means|155.98|STANDARD_ERROR_OF_MEAN|10.1|<|0.0001|TWO_SIDED|95.0|135.93|176.02||p value is calculated|Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||176.02|135.93|<.0001
72626537|NCT00285779|144781937|OTHER|||||||0.18|||||||Paired t test|||Week 24 versus baseline||||0.18
72626538|NCT00285779|144781937|OTHER|||||||0.13|||||||Paired t test|||Week 24 versus baseline||||0.13
72626539|NCT00285779|144781938|OTHER|||||||0.51|||||||Paired t test|||Week 12 versus baseline||||0.51
72626540|NCT00285779|144781938|OTHER|||||||0.47|||||||Paired t test|||Week 24 versus baseline||||0.47
72626541|NCT00285779|144781938|OTHER|||||||0.087|||||||Paired t test|||Week 24 versus baseline||||0.087
72626542|NCT00285779|144781938|OTHER|||||||0.86|||||||Paired t test|||Week 24 versus baseline||||0.86
72626543|NCT00285779|144781939|OTHER|||||||0.033|||||||Paired t test|||Week 12 versus baseline||||0.033
72626544|NCT00285779|144781939|OTHER|||||||0.069|||||||Paired t test|||Week 12 versus baseline||||0.069
72626545|NCT00285779|144781939|OTHER|||||||0.015|||||||Paired t test|||Week 24 versus baseline||||0.015
72626546|NCT00285779|144781939|OTHER|||||||0.026|||||||Paired t test|||Week 24 versus baseline||||0.026
72626547|NCT01576783|144781961|OTHER|The reported p-value is for the comparison of the change in Linoleic acid (18:2n-6) mol% between groups (DHA+AA vs. Placebo).|Mean Difference (Final Values)|-2.2|||<|0.001|TWO_SIDED|95.0|-3.4|0.9||Threshold for statistical significance (\<0.05)|Mixed Models Analysis|||The change in erythrocyte fatty acids and the change in dietary DHA and EPA (aside from the supplement) were examined by treatment group using mixed effects regression, again with a random-effect for within-family dependence.||0.9|-3.4|<0.001
72572719|NCT00593736|144672809|SUPERIORITY_OR_OTHER|||||||0.973||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.973
72572720|NCT00593736|144672809|SUPERIORITY_OR_OTHER|||||||0.117||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.117
72572721|NCT00593736|144672809|SUPERIORITY_OR_OTHER|||||||0.816||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.816
72572722|NCT00593736|144672810|SUPERIORITY_OR_OTHER|||||||0.661||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.661
72626548|NCT01576783|144781961|OTHER|The reported p-value is for the comparison of the change in Arachidonic acid (20:4n-6) mol% between groups (DHA+AA vs. Placebo).|Mean Difference (Final Values)|2.2|||<|0.001|TWO_SIDED|95.0|1.7|2.8||Threshold for statistical significance (\<0.05)|Mixed Models Analysis|||The change in erythrocyte fatty acids and the change in dietary DHA and EPA (aside from the supplement) were examined by treatment group using mixed effects regression, again with a random-effect for within-family dependence.||2.8|1.7|<0.001
72626549|NCT01576783|144781961|OTHER|The reported p-value is for the comparison of the change in Total n-6 mol% between groups (DHA+AA vs. Placebo).|Mean Difference (Final Values)|0.4||||0.61|TWO_SIDED|95.0|-1.0|1.7||Threshold for statistical significance (\<0.05)|Mixed Models Analysis|||The change in erythrocyte fatty acids and the change in dietary DHA and EPA (aside from the supplement) were examined by treatment group using mixed effects regression, again with a random-effect for within-family dependence.||1.7|-1.0|0.61
72408177|NCT05421078|144324748|SUPERIORITY||Least Squares (LS) Means|133.11|STANDARD_ERROR_OF_MEAN|10.205|<|0.0001|TWO_SIDED|95.0|112.85|153.36||p value is calculated|Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||153.36|112.85|<.0001
72408178|NCT05421078|144324748|SUPERIORITY||Least Squares (LS) Means|147.41|STANDARD_ERROR_OF_MEAN|10.195|<|0.0001|TWO_SIDED|95.0|127.17|167.64||p value is calculated|Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||167.64|127.17|<.0001
72408179|NCT05421078|144324748|SUPERIORITY||Least Squares (LS) Means|155.98|STANDARD_ERROR_OF_MEAN|10.1|<|0.0001|TWO_SIDED|95.0|135.93|176.02||p value is calculated|Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||176.02|135.93|<.0001
72408180|NCT00673452|144324792|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) Model: PGI-S = baseline PGI-S + treatment + pooled investigator + visit + treatment-by-visit + baseline-by-visit.||Patients treated with 60-120 mg duloxetine for 12 weeks compared with placebo will show greater improvement in symptoms as assessed by Patient's Global Impressions of Improvement (PGI-I). Sample size determined using 2-sided t-test with significance level of 0.05, and discontinuation rate of 5% without postbaseline data. With 261 patients per arm, study has approximately 85% power to detect treatment group difference of -0.4 points (standard deviation of 1.5) in PGI-I between treatment groups.||||<0.001
72408181|NCT00673452|144324793|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.75|||<|0.001|TWO_SIDED|95.0|-1.19|-0.31||P-value for Worst Pain Severity. P-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is 0.05.|ANCOVA|Model: BPI Score change from baseline to LOCF endpoint = BPI baseline + treatment + pooled investigator|Least Squares Mean Difference = Duloxetine minus Placebo.|||-0.31|-1.19|<0.001
72534688|NCT01945034|144597807|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3||||0.375|TWO_SIDED|95.0|-0.97|0.37|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 6(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.||0.37|-0.97|0.375
72534689|NCT01945034|144597807|SUPERIORITY_OR_OTHER||LS Mean Difference|0.2||||0.552|TWO_SIDED|95.0|-0.47|0.89|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 6(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.89|-0.47|0.552
72534690|NCT01945034|144597807|SUPERIORITY_OR_OTHER||LS Mean Difference|0.5||||0.126|TWO_SIDED|95.0|-0.14|1.12|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 6(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||1.12|-0.14|0.126
72534691|NCT01945034|144597807|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3||||0.46|TWO_SIDED|95.0|-0.47|1.05|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 6(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.||1.05|-0.47|0.460
72534692|NCT01945034|144597807|SUPERIORITY_OR_OTHER||LS Mean Difference|0.5||||0.095|TWO_SIDED|95.0|-0.09|1.09|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 7(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||1.09|-0.09|0.095
72626550|NCT01576783|144781961|OTHER|The reported p-value is for the comparison of the change in α-linolenic acid (18:3n-3) between groups (DHA+AA vs. Placebo).|Mean Difference (Final Values)|0.0||||0.4|TWO_SIDED|95.0|-0.1|0.1||Threshold for statistical significance (\<0.05)|Mixed Models Analysis|||The change in erythrocyte fatty acids and the change in dietary DHA and EPA (aside from the supplement) were examined by treatment group using mixed effects regression, again with a random-effect for within-family dependence.||0.1|-0.1|0.40
72626551|NCT01576783|144781961|OTHER|The reported p-value is for the comparison of the change in Eicosapentaenoic acid (20:5n-3) between groups (DHA+AA vs. Placebo).|Mean Difference (Final Values)|0.0||||0.12|TWO_SIDED|95.0|0.0|0.1||Threshold for statistical significance (\<0.05)|Mixed Models Analysis|||The change in erythrocyte fatty acids and the change in dietary DHA and EPA (aside from the supplement) were examined by treatment group using mixed effects regression, again with a random-effect for within-family dependence.||0.1|0.0|0.12
72408182|NCT00673452|144324793|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.61||||0.001|TWO_SIDED|95.0|-0.99|-0.24||P-value for Least Pain Severity. P-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is 0.05.|ANCOVA|Model: BPI Score change from baseline to LOCF endpoint = BPI baseline + treatment + pooled investigator|Least Squares Mean Difference = Duloxetine minus Placebo.|||-0.24|-0.99|0.001
72408183|NCT00673452|144324793|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.74|||<|0.001|TWO_SIDED|95.0|-1.13|-0.35||P-value for Average Pain Severity. P-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is 0.05.|ANCOVA|Model: BPI Score change from baseline to LOCF endpoint = BPI baseline + treatment + pooled investigator|Least Squares Mean Difference = Duloxetine minus Placebo.|||-0.35|-1.13|<0.001
72534693|NCT01945034|144597807|SUPERIORITY_OR_OTHER||LS Mean Difference|0.4||||0.146|TWO_SIDED|95.0|-0.14|0.94|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 7(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.94|-0.14|0.146
72534694|NCT01945034|144597807|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1||||0.769|TWO_SIDED|95.0|-0.75|0.56|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 7(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.||0.56|-0.75|0.769
72534695|NCT01945034|144597807|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3||||0.405|TWO_SIDED|95.0|-0.39|0.96|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 7(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.96|-0.39|0.405
72534696|NCT01945034|144597807|SUPERIORITY_OR_OTHER||LS Mean Difference|0.6||||0.073|TWO_SIDED|95.0|-0.05|1.2|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 7(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||1.20|-0.05|0.073
72534697|NCT01945034|144597807|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3||||0.458|TWO_SIDED|95.0|-0.47|1.04|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 7(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.||1.04|-0.47|0.458
72534698|NCT01945034|144597807|SUPERIORITY_OR_OTHER||LS Mean Difference|0.8||||0.009|TWO_SIDED|95.0|0.2|1.39|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 7 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||1.39|0.20|0.009
72534699|NCT01945034|144597807|SUPERIORITY_OR_OTHER||LS Mean Difference|0.4||||0.209|TWO_SIDED|95.0|-0.2|0.9|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 7 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.90|-0.20|0.209
72534700|NCT01945034|144597807|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4||||0.193|TWO_SIDED|95.0|-1.11|0.22|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 7 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.||0.22|-1.11|0.193
72534701|NCT01945034|144597807|SUPERIORITY_OR_OTHER||LS Mean Difference|0.5||||0.149|TWO_SIDED|95.0|-0.18|1.18|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 7 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||1.18|-0.18|0.149
72534702|NCT01945034|144597807|SUPERIORITY_OR_OTHER||LS Mean Difference|0.4||||0.186|TWO_SIDED|95.0|-0.21|1.06|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 7 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||1.06|-0.21|0.186
72534703|NCT01945034|144597807|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1||||0.845|TWO_SIDED|95.0|-0.84|0.69|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 7 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.||0.69|-0.84|0.845
72408184|NCT00673452|144324793|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.76|||<|0.001|TWO_SIDED|95.0|-1.2|-0.31||P-value for Pain Right Now Severity. P-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is 0.05.|ANCOVA|Model: BPI Score change from baseline to LOCF endpoint = BPI baseline + treatment + pooled investigator|Least Squares Mean Difference = Duloxetine minus Placebo.|||-0.31|-1.20|<0.001
72408185|NCT00673452|144324793|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.94|||<|0.001|TWO_SIDED|95.0|-1.39|-0.49||P-value for General Activity Interference. P-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is 0.05.|ANCOVA|Model: BPI Score change from baseline to LOCF endpoint = BPI baseline + treatment + pooled investigator|Least Squares Mean Difference = Duloxetine minus Placebo.|||-0.49|-1.39|<0.001
72408186|NCT00673452|144324793|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.95|||<|0.001|TWO_SIDED|95.0|-1.41|-0.49||P-value for Mood Interference. P-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is 0.05.|ANCOVA|Model: BPI Score change from baseline to LOCF endpoint = BPI baseline + treatment + pooled investigator|Least Squares Mean Difference = Duloxetine minus Placebo.|||-0.49|-1.41|<0.001
72408187|NCT00673452|144324793|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.8|||<|0.001|TWO_SIDED|95.0|-1.24|-0.36||P-value for Walking Ability Interference. P-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is 0.05.|ANCOVA|Model: BPI Score change from baseline to LOCF endpoint = BPI baseline + treatment + pooled investigator|Least Squares Mean Difference = Duloxetine minus Placebo.|||-0.36|-1.24|<0.001
72534704|NCT01945034|144597807|SUPERIORITY_OR_OTHER||LS Mean Difference|0.5||||0.067|TWO_SIDED|95.0|-0.04|1.14|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 7(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||1.14|-0.04|0.067
72534705|NCT01945034|144597807|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3||||0.242|TWO_SIDED|95.0|-0.22|0.87|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 7(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.87|-0.22|0.242
72534706|NCT01945034|144597807|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2||||0.498|TWO_SIDED|95.0|-0.88|0.43|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 7(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.||0.43|-0.88|0.498
72534707|NCT01945034|144597807|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3||||0.33|TWO_SIDED|95.0|-0.34|1.02|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 7(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||1.02|-0.34|0.330
72626552|NCT01576783|144781961|OTHER|The reported p-value is for the comparison of the change in Docosapentaenoic acid (22:5n-3) between groups (DHA+AA vs. Placebo).|Mean Difference (Final Values)|-0.1|||<|0.001|TWO_SIDED|95.0|-0.1|0.0||Threshold for statistical significance (\<0.05)|Mixed Models Analysis|||The change in erythrocyte fatty acids and the change in dietary DHA and EPA (aside from the supplement) were examined by treatment group using mixed effects regression, again with a random-effect for within-family dependence.||0.0|-0.1|<0.001
72408188|NCT00673452|144324793|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.76|||<|0.001|TWO_SIDED|95.0|-1.21|-0.32||P-value for Normal Work Interference. P-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is 0.05.|ANCOVA|Model: BPI Score change from baseline to LOCF endpoint = BPI baseline + treatment + pooled investigator|Least Squares Mean Difference = Duloxetine minus Placebo.|||-0.32|-1.21|<0.001
72408189|NCT00673452|144324793|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.95|||<|0.001|TWO_SIDED|95.0|-1.38|-0.52||P-value for Relations with Other People Interference. P-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is 0.05.|ANCOVA|Model: BPI Score change from baseline to LOCF endpoint = BPI baseline + treatment + pooled investigator|Least Squares Mean Difference = Duloxetine minus Placebo.|||-0.52|-1.38|<0.001
72534708|NCT01945034|144597807|SUPERIORITY_OR_OTHER||LS Mean Difference|0.5||||0.124|TWO_SIDED|95.0|-0.14|1.13|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 7(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||1.13|-0.14|0.124
72534709|NCT01945034|144597807|SUPERIORITY_OR_OTHER||LS Mean Difference|0.2||||0.687|TWO_SIDED|95.0|-0.61|0.92|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 7(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.||0.92|-0.61|0.687
72534710|NCT01945034|144597808|SUPERIORITY_OR_OTHER||LS Mean Difference|2.0||||0.166|TWO_SIDED|95.0|-0.85|4.95|||ANOVA|p-value \<=0.05 for treatment effects||At Rest over 6 Hours on Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||4.95|-0.85|0.166
72408190|NCT00673452|144324793|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.87|||<|0.001|TWO_SIDED|95.0|-1.35|-0.39||P-value for Sleep Interference. P-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is 0.05.|ANCOVA|Model: BPI Score change from baseline to LOCF endpoint = BPI baseline + treatment + pooled investigator|Least Squares Mean Difference = Duloxetine minus Placebo.|||-0.39|-1.35|<0.001
72408191|NCT00673452|144324793|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-1.39|||<|0.001|TWO_SIDED|95.0|-1.92|-0.86||P-value for Enjoyment of Life Interference. P-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is 0.05.|ANCOVA|Model: BPI Score change from baseline to LOCF endpoint = BPI baseline + treatment + pooled investigator|Least Squares Mean Difference = Duloxetine minus Placebo.|||-0.86|-1.92|<0.001
72408192|NCT00673452|144324793|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.93|||<|0.001|TWO_SIDED|95.0|-1.33|-0.52||P-value for Average Interference. P-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is 0.05.|ANCOVA|Model: BPI Score change from baseline to LOCF endpoint = BPI baseline + treatment + pooled investigator|Least Squares Mean Difference = Duloxetine minus Placebo.|||-0.52|-1.33|<0.001
72408193|NCT00673452|144324794|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.83||||0.005|TWO_SIDED|95.0|-1.41|-0.25||P-value for General Fatigue. P-value is not adjusted for multiple comparisons. The a priori threshold for statistical significance is 0.05.|ANCOVA|Model: MFI subscale change from baseline at endpoint = MFI subscale baseline + treatment + pooled investigator.|Least Squares Mean Difference = Duloxetine minus Placebo.|||-0.25|-1.41|0.005
72408194|NCT00673452|144324794|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.72||||0.013|TWO_SIDED|95.0|-1.3|-0.15||P-value for Physical Fatigue. P-value is not adjusted for multiple comparisons. The a priori threshold for statistical significance is 0.05.|ANCOVA|Model: MFI subscale change from baseline at endpoint = MFI subscale baseline + treatment + pooled investigator.|Least Squares Mean Difference = Duloxetine minus Placebo.|||-0.15|-1.30|0.013
72408195|NCT00673452|144324794|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.92||||0.003|TWO_SIDED|95.0|-1.52|-0.32||P-value for Mental Fatigue. P-value is not adjusted for multiple comparisons. The a priori threshold for statistical significance is 0.05.|ANCOVA|Model: MFI subscale change from baseline at endpoint = MFI subscale baseline + treatment + pooled investigator.|Least Squares Mean Difference = Duloxetine minus Placebo.|||-0.32|-1.52|0.003
72534711|NCT01945034|144597808|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.7||||0.199|TWO_SIDED|95.0|-4.42|0.93|||ANOVA|p-value \<=0.05 for treatment effects||At Rest over 6 Hours on Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.93|-4.42|0.199
72534712|NCT01945034|144597808|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.8||||0.022|TWO_SIDED|95.0|-7.04|-0.56|||ANOVA|p-value \<=0.05 for treatment effects||At Rest over 6 Hours on Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.||-0.56|-7.04|0.022
72534713|NCT01945034|144597808|SUPERIORITY_OR_OTHER||LS Mean Difference|1.7||||0.26|TWO_SIDED|95.0|-1.3|4.79|||ANOVA|p-value \<=0.05 for treatment effects||Weight Bearing over 6 Hours on Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||4.79|-1.30|0.260
72534714|NCT01945034|144597808|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.5||||0.729|TWO_SIDED|95.0|-3.31|2.32|||ANOVA|p-value \<=0.05 for treatment effects||Weight Bearing over 6 Hours on Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||2.32|-3.31|0.729
72626553|NCT01576783|144781961|OTHER|The reported p-value is for the comparison of the change in Docosahexaenoic acid (22:6n-3) between groups (DHA+AA vs. Placebo).|Mean Difference (Final Values)|1.2|||<|0.001|TWO_SIDED|95.0|1.0|1.5||Threshold for statistical significance (\<0.05)|Mixed Models Analysis|||The change in erythrocyte fatty acids and the change in dietary DHA and EPA (aside from the supplement) were examined by treatment group using mixed effects regression, again with a random-effect for within-family dependence.||1.5|1.0|<0.001
72408196|NCT00673452|144324794|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.88||||0.005|TWO_SIDED|95.0|-1.49|-0.26||P-value for Reduced Activity. P-value is not adjusted for multiple comparisons. The a priori threshold for statistical significance is 0.05.|ANCOVA|Model: MFI subscale change from baseline at endpoint = MFI subscale baseline + treatment + pooled investigator.|Least Squares Mean Difference = Duloxetine minus Placebo.|||-0.26|-1.49|0.005
72408197|NCT00673452|144324794|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.94|||<|0.001|TWO_SIDED|95.0|-1.49|-0.38||P-value for Reduced Motivation. P-value is not adjusted for multiple comparisons. The a priori threshold for statistical significance is 0.05.|ANCOVA|Model: MFI subscale change from baseline at endpoint = MFI subscale baseline + treatment + pooled investigator.|Least Squares Mean Difference = Duloxetine minus Placebo.|||-0.38|-1.49|<0.001
72408198|NCT00673452|144324795|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-1.89||||0.007|TWO_SIDED|95.0|-3.25|-0.53||The p-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is 0.05.|ANCOVA|Model: BDI-II Total score change from baseline to endpoint = baseline BDI-II total score + treatment + pooled investigator.|Least Squares Mean Difference = Duloxetine minus Placebo.|||-0.53|-3.25|0.007
72534715|NCT01945034|144597808|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.2||||0.196|TWO_SIDED|95.0|-5.64|1.16|||ANOVA|||Weight Bearing over 6 Hours on Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.||1.16|-5.64|0.196
72408199|NCT00673452|144324796|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.34|||<|0.001|TWO_SIDED|95.0|-0.51|-0.16||The p-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is 0.05.|ANCOVA|Model: CGI-S score change from baseline at endpoint = CGI-S score baseline + treatment + pooled investigator.|Least Squares Mean Difference = Duloxetine minus Placebo.|||-0.16|-0.51|<0.001
72408200|NCT00673452|144324797|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.07||||0.907|TWO_SIDED|95.0|-1.13|1.27||The p-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is 0.05.|ANCOVA|Model: BAI total score change from baseline to endpoint = baseline BAI total + treatment + pooled investigator.|Least Squares Mean Difference = Duloxetine minus Placebo.|||1.27|-1.13|0.907
72408201|NCT00673452|144324798|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|5.22||||0.003|TWO_SIDED|95.0|1.76|8.67||P-value for Bodily Pain. The p-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is 0.05.|ANCOVA|Model: SF-36 subscale change from baseline at endpoint = SF-36 subscale at baseline + treatment + pooled investigator.|Least Squares Mean Difference = Duloxetine minus Placebo.|||8.67|1.76|0.003
72408202|NCT00673452|144324798|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|6.42|||<|0.001|TWO_SIDED|95.0|3.41|9.43||P-value for General Health. The p-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is 0.05.|ANCOVA|Model: SF-36 subscale change from baseline at endpoint = SF-36 subscale at baseline + treatment + pooled investigator.|Least Squares Mean Difference = Duloxetine minus Placebo.|||9.43|3.41|<0.001
72408203|NCT00673452|144324798|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|7.44|||<|0.001|TWO_SIDED|95.0|4.41|10.47||P-value for Mental Health. The p-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is 0.05.|ANCOVA|Model: SF-36 subscale change from baseline at endpoint = SF-36 subscale at baseline + treatment + pooled investigator.|Least Squares Mean Difference = Duloxetine minus Placebo.|||10.47|4.41|<0.001
72408204|NCT00673452|144324798|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|5.47||||0.002|TWO_SIDED|95.0|2.06|8.88||P-value for Physical Functioning. The p-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is 0.05.|ANCOVA|Model: SF-36 subscale change from baseline at endpoint = SF-36 subscale at baseline + treatment + pooled investigator.|Least Squares Mean Difference = Duloxetine minus Placebo.|||8.88|2.06|0.002
72534716|NCT01945034|144597808|SUPERIORITY_OR_OTHER||LS Mean Difference|24.9||||0.03|TWO_SIDED|95.0|2.49|47.28|||ANOVA|p-value \<=0.05 for treatment effects||At Rest over 2 Hours on Day 3: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||47.28|2.49|0.030
72534717|NCT01945034|144597808|SUPERIORITY_OR_OTHER||LS Mean Difference|-30.2||||0.018|TWO_SIDED|95.0|-55.24|-5.23|||ANOVA|p-value \<=0.05 for treatment effects||At Rest over 2 Hours on Day 3: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||-5.23|-55.24|0.018
72534718|NCT01945034|144597808|SUPERIORITY_OR_OTHER||LS Mean Difference|-5.3||||0.611|TWO_SIDED|95.0|-25.98|15.29|||ANOVA|p-value \<=0.05 for treatment effects||At Rest over 2 Hours on Day 3: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.||15.29|-25.98|0.611
72534719|NCT01945034|144597808|SUPERIORITY_OR_OTHER||LS Mean Difference|13.8||||0.251|TWO_SIDED|95.0|-9.8|37.36|||ANOVA|p-value \<=0.05 for treatment effects||Weight Bearing over 2 Hours on Day 3: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||37.36|-9.80|0.251
72534720|NCT01945034|144597808|SUPERIORITY_OR_OTHER||LS Mean Difference|4.4||||0.689|TWO_SIDED|95.0|-17.37|26.26|||ANOVA|p-value \<=0.05 for treatment effects||Weight Bearing over 2 Hours on Day 3: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||26.26|-17.37|0.689
72534721|NCT01945034|144597808|SUPERIORITY_OR_OTHER||LS Mean Difference|-9.3||||0.486|TWO_SIDED|95.0|-35.69|17.01|||ANOVA|p-value \<=0.05 for treatment effects||Weight Bearing over 2 Hours on Day 3: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.||17.01|-35.69|0.486
72534722|NCT01945034|144597809|SUPERIORITY_OR_OTHER||LS Mean Difference|38.5||||0.021|TWO_SIDED|95.0|5.9|71.18|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Over 3 Days: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||71.18|5.90|0.021
72534723|NCT01945034|144597809|SUPERIORITY_OR_OTHER||LS Mean Difference|-7.9||||0.603|TWO_SIDED|95.0|-38.02|22.12|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Over 3 Days: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||22.12|-38.02|0.603
72534724|NCT01945034|144597809|SUPERIORITY_OR_OTHER||LS Mean Difference|-46.5||||0.013|TWO_SIDED|95.0|-82.93|-10.05|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Over 3 Days: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.||-10.05|-82.93|0.013
72534725|NCT01945034|144597810|SUPERIORITY_OR_OTHER||LS Mean Difference|87.7||||0.021|TWO_SIDED|95.0|13.48|161.85|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Over 7 days: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||161.85|13.48|0.021
72534726|NCT01945034|144597810|SUPERIORITY_OR_OTHER||LS Mean Difference|11.8||||0.735|TWO_SIDED|95.0|-56.59|80.11|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Over 7 days: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||80.11|-56.59|0.735
72534727|NCT01945034|144597810|SUPERIORITY_OR_OTHER||LS Mean Difference|-75.9||||0.072|TWO_SIDED|95.0|-158.73|6.93|||ANOVA|||At Rest Over 7 days: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.||6.93|-158.73|0.072
72534728|NCT01945034|144597810|SUPERIORITY_OR_OTHER||LS Mean Difference|46.0||||0.261|TWO_SIDED|95.0|-34.43|126.52|||ANOVA|p-value \<=0.05 for treatment effects||Weight Bearing Over 7 Days: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||126.52|-34.43|0.261
72572723|NCT00593736|144672810|SUPERIORITY_OR_OTHER|||||||0.341||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.341
72408205|NCT00673452|144324798|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|9.78||||0.004|TWO_SIDED|95.0|3.11|16.45||P-value for Role-Emotional. The p-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is 0.05.|ANCOVA|Model: SF-36 subscale change from baseline at endpoint = SF-36 subscale at baseline + treatment + pooled investigator.|Least Squares Mean Difference = Duloxetine minus Placebo.|||16.45|3.11|0.004
72534729|NCT01945034|144597810|SUPERIORITY_OR_OTHER||LS Mean Difference|37.3||||0.325|TWO_SIDED|95.0|-37.13|111.8|||ANOVA|p-value \<=0.05 for treatment effects||Weight Bearing Over 7 Days: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||111.80|-37.13|0.325
72408206|NCT00673452|144324798|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|1.59||||0.632|TWO_SIDED|95.0|-4.93|8.11||P-value for Role-Physical. The p-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is 0.05.|ANCOVA|Model: SF-36 subscale change from baseline at endpoint = SF-36 subscale at baseline + treatment + pooled investigator.|Least Squares Mean Difference = Duloxetine minus Placebo.|||8.11|-4.93|0.632
72534730|NCT01945034|144597810|SUPERIORITY_OR_OTHER||LS Mean Difference|-8.7||||0.849|TWO_SIDED|95.0|-98.64|81.22|||ANOVA|p-value \<=0.05 for treatment effects||Weight Bearing Over 7 Days: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.||81.22|-98.64|0.849
72534731|NCT01945034|144597811|SUPERIORITY_OR_OTHER||LS Mean Difference|0.2||||0.042|TWO_SIDED|95.0|0.0|0.49|||ANOVA|p-value \<=0.05 for treatment effects||Day 3: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline participant assessment of Normal Function/Activity terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.49|0.0|0.042
72534732|NCT01945034|144597811|SUPERIORITY_OR_OTHER||LS Mean Difference|0.2||||0.114|TWO_SIDED|95.0|-0.04|0.4|||ANOVA|p-value \<=0.05 for treatment effects||Day 3: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline participant assessment of Normal Function/Activity terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.40|-0.04|0.114
72534733|NCT01945034|144597811|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1||||0.598|TWO_SIDED|95.0|-0.34|0.2|||ANOVA|p-value \<=0.05 for treatment effects||Day 3: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline participant assessment of Normal Function/Activity terms.||0.20|-0.34|0.598
72534734|NCT01945034|144597811|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0||||0.833|TWO_SIDED|95.0|-0.24|0.19|||ANOVA|p-value \<=0.05 for treatment effects||Day 10: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline participant assessment of Normal Function/Activity terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.19|-0.24|0.833
72534735|NCT01945034|144597811|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0||||0.853|TWO_SIDED|95.0|-0.18|0.22|||ANOVA|p-value \<=0.05 for treatment effects||Day 10: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline participant assessment of Normal Function/Activity terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.22|-0.18|0.853
72534736|NCT01945034|144597811|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0||||0.733|TWO_SIDED|95.0|-0.2|0.29|||ANOVA|p-value \<=0.05 for treatment effects||Day 10: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline participant assessment of Normal Function/Activity terms.||0.29|-0.20|0.733
72534737|NCT01945034|144597813|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.45||||0.016|TWO_SIDED|95.0|1.07|1.97|||Proportional Hazards Model|p-value \<=0.05 for treatment effects||Time to First Perceptible Relief: Hazard Ratio and corresponding 95% CI were calculated based on the Wald statistic from the Proportional Hazards (PH) model with treatment, BLPSR, and pooled site blocks.||1.97|1.07|0.016
72534738|NCT01945034|144597813|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.71||||0.022|TWO_SIDED|95.0|0.53|0.95|||Proportional Hazards Model|p-value \<=0.05 for treatment effects||Time to First Perceptible Relief: Hazard Ratio and corresponding 95% CI were calculated based on the Wald statistic from the PH model with treatment, BLPSR, and pooled site blocks.||0.95|0.53|0.022
72534739|NCT01945034|144597813|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.49|||<|0.001|TWO_SIDED|95.0|0.34|0.69|||Proportional Hazards Model|p-value \<=0.05 for treatment effects||Time to First Perceptible Relief: Hazard Ratio and corresponding 95% CI were calculated based on the Wald statistic from the PH model with treatment, BLPSR, and pooled site blocks.||0.69|0.34|< 0.001
72534740|NCT01945034|144597813|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.79|||<|0.001|TWO_SIDED|95.0|1.27|2.51|||Proportional Hazards Model|p-value \<=0.05 for treatment effects||Time to Meaningful Relief: Hazard Ratio and corresponding 95% CI were calculated based on the Wald statistic from the PH model with treatment, BLPSR, and pooled site blocks.||2.51|1.27|< 0.001
72534741|NCT01945034|144597813|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.6||||0.009|TWO_SIDED|95.0|0.41|0.88|||Proportional Hazards Model|p-value \<=0.05 for treatment effects||Time to Meaningful Relief: Hazard Ratio and corresponding 95% CI were calculated based on the Wald statistic from the PH model with treatment, BLPSR, and pooled site blocks.||0.88|0.41|0.009
72534742|NCT01945034|144597813|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.34|||<|0.001|TWO_SIDED|95.0|0.22|0.52|||Proportional Hazards Model|p-value \<=0.05 for treatment effects||Time to Meaningful Relief: Hazard Ratio and corresponding 95% CI were calculated based on the Wald statistic from the PH model with treatment, BLPSR, and pooled site blocks.||0.52|0.22|< 0.001
72534743|NCT01945034|144597815|SUPERIORITY_OR_OTHER|||||||0.479|||||||Cochran-Mantel-Haenszel|p-values from the Cochran-Mantel-Haenszel (CMH) test with modified ridit scores, controlling for BLPSR and site block.||||||0.479
72534744|NCT01945034|144597815|SUPERIORITY_OR_OTHER|||||||0.279|||||||Cochran-Mantel-Haenszel|p-values from the CMH test with modified ridit scores, controlling for BLPSR and site block.||||||0.279
72534745|NCT01945034|144597815|SUPERIORITY_OR_OTHER|||||||0.129|||||||Cochran-Mantel-Haenszel|p-values from the CMH test with modified ridit scores, controlling for BLPSR and site block.||||||0.129
72534746|NCT01798056|144597817|NON_INFERIORITY|Criteria used: The lower limit (LL) of the 95% confidence interval (CI) of the Geometric Mean (GM) ratio (GSK1437173A PreChemo group over Placebo PreChemo group) in anti-gE ELISA antibody concentrations is greater than 3.|Adjusted GMC ratio|23.2|||||TWO_SIDED|95.0|17.9|30.0||||Difference of means between vaccines and placebo were calculated together with 2-sided confidence intervals and back-transformed to the original units||The analysis evaluated the anti-gE humoral immune responses at Month 2, following a two-dose administration of the GSK1437173A vaccine, as compared to placebo in subjects with solid tumours receiving chemotherapy (PreChemo Groups only).||30|17.9|
72534747|NCT04621227|144597886|OTHER|The ratio and 90% confidence interval were expressed as percentages.|Adjusted Geometric Mean Ratio (%)|202.94|||||TWO_SIDED|90.0|167.14|246.41|||Mixed Models Analysis|||Comparison for AUClast (PF-06882961 120mg BID + rosuvastatin 10mg \[Period 4\] vs Rosuvastatin 10mg \[Period 1\])||246.41|167.14|
72534748|NCT04621227|144597886|OTHER|The ratio and 90% confidence interval were expressed as percentages.|Adjusted Geometric Mean Ratio (%)|283.73|||||TWO_SIDED|90.0|233.68|344.51|||Mixed Models Analysis|||Comparison for AUClast (PF-06882961 200mg BID + rosuvastatin 10mg \[Period 7\] vs Rosuvastatin 10mg \[Period 1\])||344.51|233.68|
72534749|NCT04621227|144597887|OTHER|The ratio and 90% confidence interval were expressed as percentages.|Adjusted Geometric Mean Ratio (%)|50.57|||||TWO_SIDED|90.0|42.27|60.5|||Mixed Models Analysis|||Comparison for AUClast (PF-06882961 120mg BID + midazolam 2mg \[Period 5\] vs Midazolam 2mg \[Period 2\])||60.50|42.27|
72534750|NCT04621227|144597887|OTHER|The ratio and 90% confidence interval were expressed as percentages.|Adjusted Geometric Mean Ratio (%)|50.56|||||TWO_SIDED|90.0|42.06|60.78|||Mixed Models Analysis|||Comparison for AUClast (PF-06882961 200mg BID + midazolam 2mg \[Period 8\] vs Midazolam 2mg \[Period 2\])||60.78|42.06|
72534751|NCT01342445|144597904|SUPERIORITY_OR_OTHER_LEGACY||Partial eta squared|0.34|||<|0.001||||||we adjusted p values to control for the false discovery rate using procedures described by Benjamini and Hochberg (1995). Thus, an alpha value of .021 was used as significance threshold.|ANOVA|"F(4, 84) = 10.9~This was a one-way ANOVA with repeated measures across dosage conditions (no drug baseline, placebo, 30-mg, 50-mg, 70-mg LDX)."||This was a within-subject crossover design with all participants going through a no-drug baseline followed by placebo and three dosages of LDX, with the latter four conditions in a randomly assigned, counterbalanced order. The comparison condition was the placebo condition.||||<0.001
72534752|NCT01342445|144597905|SUPERIORITY_OR_OTHER_LEGACY||partial eta squared|0.28|||<|0.001||||||we adjusted p values to control for the false discovery rate using procedures described by Benjamini and Hochberg (1995). Thus, an alpha value of .021 was used as significance threshold.|ANOVA|"F(4, 84) = 8.14~This was a one-way ANOVA with repeated measures across dosage conditions (no drug baseline, placebo, 30-mg, 50-mg, 70-mg LDX)."||This was a within-subject crossover design with all participants going through a no-drug baseline followed by placebo and three dosages of LDX, with the latter four conditions in a randomly assigned, counterbalanced order. The comparison condition was the placebo condition.||||<.001
72534753|NCT05299359|144597906|NON_INFERIORITY|If the lower limit of the 95% CI is \>= 0.67, then the immune response to a single heterologous booster vaccination of TAK-019 is considered to be non-inferior of that to the primary series of TAK-019.|LS Mean Difference|1.18|||||TWO_SIDED|95.0|0.95|1.47||||||GMT ratio was calculated GMT of TAK-019-3001 on Day 15 divided by GMT of TAK-019-1501 study on Day 36.||1.47|0.95|
72534754|NCT02652793|144597954|SUPERIORITY|Single-arm pilot study to assess BMD improvement after switching therapy. Null hypothesis: no change in lumbar spine BMD at Week 48. Sample size of 45 planned to detect a 2% increase with 90% power (α=0.025). Final analysis included 30 participants.|Mean Difference (Final Values)|0.01|STANDARD_DEVIATION|0.03||0.0239|TWO_SIDED|95.0|0.001|0.019||Statistical test applied to lumbar spine BMD only. P-value reflects within-group change from baseline to Week 48.|Regression, Linear|Per-protocol analysis; missing data excluded|Represents mean change in lumbar spine BMD from baseline to Week 48.|Single-arm study; no comparator group||0.019|0.001|0.0239
72534755|NCT02652793|144597954|SUPERIORITY|Single-arm pilot study to assess BMD improvement after switching therapy. Null hypothesis: no change in left hip BMD at Week 48. Sample size of 45 planned to detect a 2% increase with 90% power (α=0.025). Final analysis included 30 participants.|Mean Difference (Final Values)|0.013|STANDARD_DEVIATION|0.03||0.0046|TWO_SIDED|95.0|0.004|0.023||Left hip|Regression, Linear|Statistical test applied to left hip BMD only. P-value reflects within-group change from baseline to Week 48.|Represents mean change in left hip BMD from baseline to Week 48|Single-arm study; no comparator group||0.023|0.004|0.0046
72534756|NCT04579666|144597988|SUPERIORITY||Difference in LS Mean|-3.0||||0.7205|TWO_SIDED|95.0|-19.5|13.5|||ANCOVA|||Analysis of covariance (ANCOVA) was used to analyze the ranks of the CAFS score with treatment as a fixed effect, adjusted for baseline ALSFRS-R total score, time from symptom onset, baseline Log neurofilament light chain (NfL), and the randomization stratification factors (location of first muscle weakness and use of riluzole and edaravone).||13.5|-19.5|0.7205
72534757|NCT04579666|144597993|SUPERIORITY||Difference in LS Mean|-0.7||||0.6447|TWO_SIDED|95.0|-3.5|2.2|||MMRM|||The mixed-effect model for repeated measures (MMRM) included fixed categorical effects for treatment, week, and the week-by-treatment interaction, as well as the continuous, fixed covariate of the baseline value of the endpoint, and the week-by-baseline interaction, baseline log NfL, time from symptoms onset to the first dose of study drug, and randomization stratification factors location of first muscle weakness and use of riluzole and/or edaravone).||2.2|-3.5|0.6447
72572724|NCT00593736|144672810|SUPERIORITY_OR_OTHER|||||||0.853||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.853
72572725|NCT00593736|144672811|SUPERIORITY_OR_OTHER|||||||0.365||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.365
72572726|NCT00593736|144672811|SUPERIORITY_OR_OTHER|||||||0.121||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.121
72572727|NCT00593736|144672811|SUPERIORITY_OR_OTHER|||||||0.268||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.268
72572728|NCT00593736|144672812|SUPERIORITY_OR_OTHER|||||||0.9||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.900
72572729|NCT00593736|144672812|SUPERIORITY_OR_OTHER|||||||0.525||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.525
72572730|NCT00593736|144672812|SUPERIORITY_OR_OTHER|||||||0.418||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.418
72572731|NCT00593736|144672813|SUPERIORITY_OR_OTHER|||||||0.051||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.051
72572732|NCT00593736|144672813|SUPERIORITY_OR_OTHER|||||||0.926||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.926
72572733|NCT00593736|144672813|SUPERIORITY_OR_OTHER|||||||0.166||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.166
72572734|NCT00593736|144672814|SUPERIORITY_OR_OTHER|||||||0.511||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.511
72408207|NCT00673452|144324798|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|6.67|||<|0.001|TWO_SIDED|95.0|2.73|10.61||P-value for Social Functioning. The p-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is 0.05.|ANCOVA|Model: SF-36 subscale change from baseline at endpoint = SF-36 subscale at baseline + treatment + pooled investigator.|Least Squares Mean Difference = Duloxetine minus Placebo.|||10.61|2.73|<0.001
72572735|NCT00593736|144672814|SUPERIORITY_OR_OTHER|||||||0.082||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.082
72572736|NCT00593736|144672814|SUPERIORITY_OR_OTHER|||||||0.188||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.188
72572737|NCT00593736|144672815|SUPERIORITY_OR_OTHER|||||||0.691||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.691
72572738|NCT00593736|144672815|SUPERIORITY_OR_OTHER|||||||0.323||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.323
72572739|NCT00593736|144672815|SUPERIORITY_OR_OTHER|||||||0.324||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.324
72572740|NCT00593736|144672816|SUPERIORITY_OR_OTHER|||||||0.197||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.197
72572741|NCT00593736|144672816|SUPERIORITY_OR_OTHER|||||||0.871||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.871
72626554|NCT01576783|144781961|OTHER|The reported p-value is for the comparison of the change in Total n-3 between groups (DHA+AA vs. Placebo).|Mean Difference (Final Values)|1.2|||<|0.001|TWO_SIDED|95.0|0.9|1.4||Threshold for statistical significance (\<0.05)|Mixed Models Analysis|||The change in erythrocyte fatty acids and the change in dietary DHA and EPA (aside from the supplement) were examined by treatment group using mixed effects regression, again with a random-effect for within-family dependence.||1.4|0.9|<0.001
72572742|NCT00593736|144672816|SUPERIORITY_OR_OTHER|||||||0.737||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.737
72534758|NCT04579666|144597994|SUPERIORITY||Difference in LS Mean|-6.6||||0.0949|TWO_SIDED|95.0|-14.3|1.2|||MMRM|||The MMRM included fixed categorical effects for treatment, week, and the week-by-treatment interaction, as well as the continuous, fixed covariate of the baseline value of the endpoint, and the week-by-baseline interaction, baseline log NfL, time from symptoms onset to the first dose of study drug, and randomization stratification factors (location of first muscle weakness and use of riluzole and/or edaravone).||1.2|-14.3|0.0949
72534759|NCT04579666|144597995|SUPERIORITY||Difference in LS Mean|-0.19||||0.0935|TWO_SIDED|95.0|-0.42|0.03|||MMRM|||The MMRM included fixed categorical effects for treatment, week, and the week-by-treatment interaction, as well as the continuous, fixed covariate of the baseline value of the endpoint, and the week-by-baseline interaction, baseline log NfL, time from symptoms onset to the first dose of study drug, and randomization stratification factors (location of first muscle weakness and use of riluzole and/or edaravone).||0.03|-0.42|0.0935
72534760|NCT04579666|144597997|SUPERIORITY||Difference in LS Mean|6.5||||0.0069|TWO_SIDED|95.0|1.8|11.1|||MMRM|||The MMRM included fixed categorical effects for treatment, week, and the week-by-treatment interaction, as well as the continuous, fixed covariate of the baseline value of the endpoint, and the week-by-baseline interaction, baseline log NfL, time from symptoms onset to the first dose of study drug, and randomization stratification factors (location of first muscle weakness and use of riluzole and/or edaravone).||11.1|1.8|0.0069
72534761|NCT01151085|144598031|SUPERIORITY_OR_OTHER||||||=|0.03|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Gender. The null hypothesis is there is no difference between Male and Female  in the Frequency of Treatment Related Adverse Events."||||=0.030
72534762|NCT01151085|144598032|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Chi-squared|||"The risk factor tested was Severity of infections. The null hypothesis is there is no difference among mild, moderate and severe in the Frequency of Treatment Related Adverse Events."||||<0.001
72534763|NCT01151085|144598033|SUPERIORITY_OR_OTHER||||||=|0.017|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Past History. The null hypothesis is there is no difference between with and without Past History in the Frequency of Treatment Related Adverse Events."||||=0.017
72534764|NCT01151085|144598034|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Chi-squared|||Statistical Analysis for Risk Factors for the Proportion of Responders to Voriconazole treatment -Severity of infections.||||<0.001
72534765|NCT03413618|144598072|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||||||<0.0001
72534766|NCT03413618|144598073|SUPERIORITY|||||||0.049|||||||Log Rank|||||||0.049
72534767|NCT03413618|144598075|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||||||<0.0001
72534768|NCT03413618|144598076|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||||||<0.0001
72534769|NCT03413618|144598078|SUPERIORITY|||||||0.001|||||||Fisher Exact|||||||0.001
72534770|NCT03413618|144598079|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.000
72534771|NCT04196023|144598095|SUPERIORITY|||||||0.2||||||p-value was calculated using GLM. Statistical significance was determined using an alpha level of 0.05.|general linear model|adjusted for age, sex, education and baseline overall MoCA score||||||0.20
72572743|NCT00593736|144672817|SUPERIORITY_OR_OTHER|||||||0.972||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.972
72572744|NCT00593736|144672817|SUPERIORITY_OR_OTHER|||||||0.117||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.117
72572745|NCT00593736|144672817|SUPERIORITY_OR_OTHER|||||||0.811||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.811
72534772|NCT04196023|144598096|SUPERIORITY|||||||0.9||||||p-value was calculated using GLM model. Statistical significance was determined using an alpha level of 0.05.|general linear model|GLM model additionally adjusting for age, sex, education and baseline level.||||||0.90
72534773|NCT04196023|144598097|SUPERIORITY|||||||0.01||||||p-value was calculated using GLM model. Statistical significance was determined using an alpha level of 0.05.|general linear model|GLM model additionally adjusting for age, sex, education and baseline level.||||||0.01
72534774|NCT04196023|144598098|SUPERIORITY|||||||0.05||||||p-value was calculated using GLM model and false discovery rate (FDR)-adjustment. Statistical significance was determined using an alpha level of 0.05.|general linear model|GLM model additionally adjusting for age, sex, education and baseline level.||||||0.05
72534775|NCT04359758|144598108|SUPERIORITY|||||||0.14|||||||Chi-squared|||The study was powered assuming 10% genetic testing uptake UC compared to 35% in ST. assuming these uptake rates and a two-tailed alpha of 0.05, a sample size of n=50 per arm would yield greater than 80% power.||||0.14
72534776|NCT04359758|144598108|SUPERIORITY||Odds Ratio (OR)|2.57||||0.039|TWO_SIDED|95.0|1.05|6.29|||Regression, Logistic|||Because education and marital status have been associated with genetic testing participation in prior research, we conducted a follow-up analysis in which we adjusted for education and marital status.||6.29|1.05|0.039
72534777|NCT04359758|144598109|SUPERIORITY|||||||0.13|||||||t-test, 2 sided|101 degrees of freedom.||||||0.13
72534778|NCT04359758|144598110|SUPERIORITY|||||||0.78|||||||t-test, 2 sided|df=102||||||0.78
72534779|NCT04359758|144598111|SUPERIORITY|||||||0.97|||||||ANCOVA|df = 1, 101||Analysis of PROMIS anxiety||||0.97
72534780|NCT04359758|144598111|SUPERIORITY|||||||0.34|||||||ANCOVA|df = 1, 101||Analysis of PROMIS Depression||||0.34
72534781|NCT04753606|144598115|SUPERIORITY||Least Squares (LS) Means|-32.96|STANDARD_ERROR_OF_MEAN|4.943|<|0.0001|TWO_SIDED|95.0|-44.03|-21.9|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-21.90|-44.03|<.0001
72534782|NCT04753606|144598115|SUPERIORITY||Least Squares (LS) Means|-39.18|STANDARD_ERROR_OF_MEAN|4.927|<|0.0001|TWO_SIDED|95.0|-50.21|-28.15|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-28.15|-50.21|<.0001
72534783|NCT04753606|144598116|SUPERIORITY||Least Squares (LS) Means|-32.96|STANDARD_ERROR_OF_MEAN|4.943|<|0.0001|TWO_SIDED|95.0|-44.03|-21.9|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-21.90|-44.03|<.0001
72534784|NCT04753606|144598116|SUPERIORITY||Least Squares (LS) Means|-39.18|STANDARD_ERROR_OF_MEAN|4.927|<|0.0001|TWO_SIDED|95.0|-50.21|-28.15|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-28.15|-50.21|<.0001
72534785|NCT04753606|144598117|SUPERIORITY||Least Squares (LS) Means|-32.96|STANDARD_ERROR_OF_MEAN|4.943|<|0.0001|TWO_SIDED|95.0|-44.03|-21.9|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-21.90|-44.03|<.0001
72534786|NCT04753606|144598117|SUPERIORITY||Least Squares (LS) Means|-39.18|STANDARD_ERROR_OF_MEAN|4.927|<|0.0001|TWO_SIDED|95.0|-50.21|-28.15|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-28.15|-50.21|<.0001
72572746|NCT00593736|144672818|SUPERIORITY_OR_OTHER|||||||0.659||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.659
72572747|NCT00593736|144672818|SUPERIORITY_OR_OTHER|||||||0.337||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.337
72626555|NCT01576783|144781962|OTHER|The reported p-value is for the comparison of the change in n-6:n-3 ratio between groups (DHA+AA vs. Placebo).|Mean Difference (Final Values)|-4.6|||<|0.001|TWO_SIDED|95.0|-5.5|-3.7||Threshold for statistical significance (\<0.05)|Mixed Models Analysis|||The change in erythrocyte fatty acids and the change in dietary DHA and EPA (aside from the supplement) were examined by treatment group using mixed effects regression, again with a random-effect for within-family dependence.||-3.7|-5.5|<0.001
72534787|NCT04753606|144598118|SUPERIORITY||Least Squares (LS) Means|-28.94|STANDARD_ERROR_OF_MEAN|4.643|<|0.0001|TWO_SIDED|95.0|-38.14|-19.74|||ANCOVA|||||-19.74|-38.14|<.0001
72534788|NCT04753606|144598118|SUPERIORITY||Least Squares (LS) Means|-40.07|STANDARD_ERROR_OF_MEAN|4.591|<|0.0001|TWO_SIDED|95.0|-49.16|-30.97|||ANCOVA|||||-30.97|-49.16|<.0001
72534789|NCT04753606|144598119|SUPERIORITY||Least Squares (LS) Means|-28.94|STANDARD_ERROR_OF_MEAN|4.643|<|0.0001|TWO_SIDED|95.0|-38.14|-19.74|||ANCOVA|||||-19.74|-38.14|<.0001
72534790|NCT04753606|144598119|SUPERIORITY||Least Squares (LS) Means|-40.07|STANDARD_ERROR_OF_MEAN|4.591|<|0.0001|TWO_SIDED|95.0|-49.16|-30.97|||ANCOVA|||||-30.97|-49.16|<.0001
72534791|NCT04753606|144598120|SUPERIORITY||Least Squares (LS) Means|-28.94|STANDARD_ERROR_OF_MEAN|4.643|<|0.0001|TWO_SIDED|95.0|-38.14|-19.74|||ANCOVA|||||-19.74|-38.14|<.0001
72534792|NCT04753606|144598120|SUPERIORITY||Least Squares (LS) Means|-40.07|STANDARD_ERROR_OF_MEAN|4.591|<|0.0001|TWO_SIDED|95.0|-49.16|-30.97|||ANCOVA|||||-30.97|-49.16|<.0001
72534793|NCT04753606|144598121|SUPERIORITY||Least Squares (LS) Means|-18.26|STANDARD_ERROR_OF_MEAN|3.657|<|0.0001|TWO_SIDED|95.0|-25.51|-11.02|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-11.02|-25.51|<.0001
72534794|NCT04753606|144598121|SUPERIORITY||Least Squares (LS) Means|-23.99|STANDARD_ERROR_OF_MEAN|3.65|<|0.0001|TWO_SIDED|95.0|-31.22|-16.76|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-16.76|-31.22|<.0001
72534795|NCT04753606|144598122|SUPERIORITY||Least Squares (LS) Means|-18.26|STANDARD_ERROR_OF_MEAN|3.657|<|0.0001|TWO_SIDED|95.0|-25.51|-11.02|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-11.02|-25.51|<.0001
72572748|NCT00593736|144672818|SUPERIORITY_OR_OTHER|||||||0.853||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.853
72626556|NCT01576783|144781965|OTHER|The reported p-value is for the comparison of the change in Effortful Control Composite scores between groups (DHA+AA vs. Placebo).||||||0.13||||||Threshold for statistical significance (\<0.05)|Mixed Models Analysis|Analyses compared the change in scores between groups, using mixed effects regression that leveraged maximum likelihood to include missing data.||||||.13
72626557|NCT01576783|144781965|OTHER|The reported p-value is for the comparison of the change in Activity Level Composite scores between groups (DHA+AA vs. Placebo).||||||0.76||||||Threshold for statistical significance (\<0.05)|Mixed Models Analysis|||||||.76
72534796|NCT04753606|144598122|SUPERIORITY||Least Squares (LS) Means|-23.99|STANDARD_ERROR_OF_MEAN|3.65|<|0.0001|TWO_SIDED|95.0|-31.22|-16.76|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-16.76|-31.22|<.0001
72534797|NCT04753606|144598123|SUPERIORITY||Least Squares (LS) Means|-18.26|STANDARD_ERROR_OF_MEAN|3.657|<|0.0001|TWO_SIDED|95.0|-25.51|-11.02|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-11.02|-25.51|<.0001
72534798|NCT04753606|144598123|SUPERIORITY||Least Squares (LS) Means|-23.99|STANDARD_ERROR_OF_MEAN|3.65|<|0.0001|TWO_SIDED|95.0|-31.22|-16.76|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-16.76|-31.22|<.0001
72534799|NCT04753606|144598124|SUPERIORITY||Least Squares (LS) Means|-30.54|STANDARD_ERROR_OF_MEAN|4.503|<|0.0001|TWO_SIDED|95.0|-39.46|-21.62|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-21.62|-39.46|<.0001
72534800|NCT04753606|144598124|SUPERIORITY||Least Squares (LS) Means|-36.03|STANDARD_ERROR_OF_MEAN|4.488|<|0.0001|TWO_SIDED|95.0|-44.92|-27.14|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-27.14|-44.92|<.0001
72534801|NCT04753606|144598125|SUPERIORITY||Least Squares (LS) Means|-30.54|STANDARD_ERROR_OF_MEAN|4.503|<|0.0001|TWO_SIDED|95.0|-39.46|-21.62|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-21.62|-39.46|<.0001
72408208|NCT00673452|144324798|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|4.31||||0.015|TWO_SIDED|95.0|0.84|7.79||P-value for Vitality. The p-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is 0.05.|ANCOVA|Model: SF-36 subscale change from baseline at endpoint = SF-36 subscale at baseline + treatment + pooled investigator.|Least Squares Mean Difference = Duloxetine minus Placebo.|||7.79|0.84|0.015
72534802|NCT04753606|144598125|SUPERIORITY||Least Squares (LS) Means|-36.03|STANDARD_ERROR_OF_MEAN|4.488|<|0.0001|TWO_SIDED|95.0|-44.92|-27.14|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-27.14|-44.92|<.0001
72534803|NCT04753606|144598126|SUPERIORITY||Least Squares (LS) Means|-30.54|STANDARD_ERROR_OF_MEAN|4.503|<|0.0001|TWO_SIDED|95.0|-39.46|-21.62|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-21.62|-39.46|<.0001
72534804|NCT04753606|144598126|SUPERIORITY||Least Squares (LS) Means|-36.03|STANDARD_ERROR_OF_MEAN|4.488|<|0.0001|TWO_SIDED|95.0|-44.92|-27.14|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-27.14|-44.92|<.0001
72534805|NCT04753606|144598127|SUPERIORITY||Least Squares (LS) Means|129.27|STANDARD_ERROR_OF_MEAN|9.337|<|0.0001|TWO_SIDED|95.0|110.78|147.77|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||147.77|110.78|<.0001
72534806|NCT04753606|144598127|SUPERIORITY||Least Squares (LS) Means|164.33|STANDARD_ERROR_OF_MEAN|9.306|<|0.0001|TWO_SIDED|95.0|145.9|182.76|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||182.76|145.90|<.0001
72534807|NCT04753606|144598128|SUPERIORITY||Least Squares (LS) Means|129.27|STANDARD_ERROR_OF_MEAN|9.337|<|0.0001|TWO_SIDED|95.0|110.78|147.77|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||147.77|110.78|<.0001
72534808|NCT04753606|144598128|SUPERIORITY||Least Squares (LS) Means|164.33|STANDARD_ERROR_OF_MEAN|9.306|<|0.0001|TWO_SIDED|95.0|145.9|182.76|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||182.76|145.90|<.0001
72534809|NCT04753606|144598129|SUPERIORITY||Least Squares (LS) Means|129.27|STANDARD_ERROR_OF_MEAN|9.337|<|0.0001|TWO_SIDED|95.0|110.78|147.77|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||147.77|110.78|<.0001
72534810|NCT04753606|144598129|SUPERIORITY||Least Squares (LS) Means|164.33|STANDARD_ERROR_OF_MEAN|9.306|<|0.0001|TWO_SIDED|95.0|145.9|182.76|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||182.76|145.90|<.0001
72534811|NCT00489411|144598130|SUPERIORITY_OR_OTHER||Mean Difference|0.73||||0.003|TWO_SIDED|95.0|0.26|1.2|||Wilcoxon (Mann-Whitney)|||||1.20|0.26|0.003
72534812|NCT00489411|144598131|SUPERIORITY_OR_OTHER||Mean Difference|4.4|||||TWO_SIDED|95.0|0.93|7.88||||||||7.88|0.93|
72534813|NCT00489411|144598132|SUPERIORITY_OR_OTHER||Mean Difference|1.58||||0.03|TWO_SIDED|95.0|0.15|3.0|||Wilcoxon (Mann-Whitney)|||||3.00|0.15|0.03
72534814|NCT00489411|144598133|SUPERIORITY_OR_OTHER||Mean difference|1.01|||||TWO_SIDED|95.0|0.36|1.65||||||||1.65|0.36|
72534815|NCT03841331|144598136|SUPERIORITY||Treatment Effect|-1.4||||0.5861|TWO_SIDED|95.0|-13.9|11.1|||Cochran-Mantel-Haenszel||95% Wald confidence intervals for the treatment difference was used|At Week 10||11.1|-13.9|0.5861
72534816|NCT03841331|144598137|SUPERIORITY||Treatment Effect|-0.7||||0.5651|TWO_SIDED|95.0|-10.1|8.7|||Cochran-Mantel-Haenszel||95% Wald confidence intervals for the treatment difference was used.|At Week 2||8.7|-10.1|0.5651
72534817|NCT03841331|144598137|SUPERIORITY||Treatment Effect|-4.1||||0.7769|TWO_SIDED|95.0|-14.8|6.7|||Cochran-Mantel-Haenszel|||At Week 4|95% Wald confidence intervals for the treatment difference was used.|6.7|-14.8|0.7769
72534818|NCT03841331|144598137|SUPERIORITY||Treatment Effect|2.8||||0.3285|TWO_SIDED|95.0|-9.1|14.8|||Cochran-Mantel-Haenszel||95% Wald confidence intervals for the treatment difference was used.|At Week 6||14.8|-9.1|0.3285
72572749|NCT00593736|144672819|SUPERIORITY_OR_OTHER|||||||0.206||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.206
72572750|NCT00593736|144672819|SUPERIORITY_OR_OTHER|||||||0.495||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.495
72572751|NCT00593736|144672819|SUPERIORITY_OR_OTHER|||||||0.8||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.800
72408209|NCT00673452|144324798|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|1.14||||0.134|TWO_SIDED|95.0|-0.35|2.64||P-value for Physical Component Summary (PCS). The p-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is 0.05.|ANCOVA|Model: SF-36 subscale change from baseline at endpoint = SF-36 subscale at baseline + treatment + pooled investigator.|Least Squares Mean Difference = Duloxetine minus Placebo.|||2.64|-0.35|0.134
72534819|NCT03841331|144598137|SUPERIORITY||Treatment Effect|-2.3||||0.6525|TWO_SIDED|95.0|-14.4|9.8|||Cochran-Mantel-Haenszel||95% Wald confidence intervals for the treatment difference was used.|At Week 8||9.8|-14.4|0.6525
72534820|NCT03841331|144598138|SUPERIORITY||Treatment effect|0.0||||0.4952|TWO_SIDED|95.0|-5.6|5.7|||Cochran-Mantel-Haenszel||95% Wald confidence intervals for the treatment difference was used.|At Week 2||5.7|-5.6|0.4952
72534821|NCT03841331|144598138|SUPERIORITY||Treatment effect|5.2||||0.0891|TWO_SIDED|95.0|-2.3|12.7|||Cochran-Mantel-Haenszel||95% Wald confidence intervals for the treatment difference was used.|At Week 4||12.7|-2.3|0.0891
72534822|NCT03841331|144598138|SUPERIORITY||Treatment effect|-4.2||||0.8447|TWO_SIDED|95.0|-12.1|3.7|||Cochran-Mantel-Haenszel||95% Wald confidence intervals for the treatment difference was used.|At Week 6||3.7|-12.1|0.8447
72534823|NCT03841331|144598138|SUPERIORITY||Treatment effect|1.0||||0.4174|TWO_SIDED|95.0|-7.5|9.4|||Cochran-Mantel-Haenszel||95% Wald confidence intervals for the treatment difference was used.|At Week 8||9.4|-7.5|0.4174
72534824|NCT03841331|144598138|SUPERIORITY||Treatment effect|2.7||||0.2756|TWO_SIDED|95.0|-5.8|11.2|||Cochran-Mantel-Haenszel||95% Wald confidence intervals for the treatment difference was used.|At Week 10||11.2|-5.8|0.2756
72534825|NCT03841331|144598139|SUPERIORITY||Mean Difference (Final Values)|0.04||||0.4409|TWO_SIDED|95.0|-0.49|0.57|||ANOVA|||At Week 2||0.57|-0.49|0.4409
72534826|NCT03841331|144598139|SUPERIORITY||Mean Difference (Final Values)|-0.04||||0.5496|TWO_SIDED|95.0|-0.65|0.57||At week 4|ANOVA|||At Week 4||0.57|-0.65|0.5496
72534827|NCT03841331|144598139|SUPERIORITY||Mean Difference (Final Values)|-0.11||||0.6311|TWO_SIDED|95.0|-0.78|0.55|||ANOVA|||At Week 6||0.55|-0.78|0.6311
72534828|NCT03841331|144598139|SUPERIORITY||Mean Difference (Final Values)|0.4738||||0.02|TWO_SIDED|95.0|-0.65|0.69|||ANOVA|||At Week 8||0.69|-0.65|0.02
72534829|NCT03841331|144598139|SUPERIORITY||Mean Difference (Final Values)|0.09||||0.3948|TWO_SIDED|95.0|-0.6|0.78|||ANOVA|||At Week 10||0.78|-0.60|0.3948
72534830|NCT03841331|144598141|SUPERIORITY||Mean Difference (Final Values)|2.44||||0.244|TWO_SIDED|95.0|-4.98|9.87|||ANOVA|||At Week 2||9.87|-4.98|0.2440
72534831|NCT03841331|144598141|SUPERIORITY||Mean Difference (Final Values)|-1.27||||0.6349|TWO_SIDED|95.0|-9.2|6.65|||ANOVA|||At Week 4||6.65|-9.20|0.6349
72534832|NCT03841331|144598141|SUPERIORITY||Mean Difference (Final Values)|0.3407||||1.91|TWO_SIDED|95.0|-6.4|10.23|||ANOVA|||At Week 6||10.23|-6.40|1.91
72534833|NCT03841331|144598141|SUPERIORITY||Mean Difference (Final Values)|0.23||||0.496|TWO_SIDED|95.0|-8.52|8.97|||ANOVA|||At Week 10||8.97|-8.52|0.4960
72534834|NCT02743117|144598144|SUPERIORITY_OR_OTHER||Rate Difference|-1.3|||||TWO_SIDED|95.0|-8.1|1.3||||||||1.3|-8.1|
72534835|NCT02743117|144598145|SUPERIORITY_OR_OTHER||Rate Difference|-8.2|||||TWO_SIDED|95.0|-22.2|4.6||||||Up to Day 8||4.6|-22.2|
72534836|NCT02743117|144598145|SUPERIORITY_OR_OTHER||Rate Difference|-7.4|||||TWO_SIDED|95.0|-21.6|5.9||||||Up to Day 15||5.9|-21.6|
72534837|NCT01207219|144598149|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED|||||The p-value for statistical significance in these analyses was 0.01 adjusted for multiple comparisons .|Mixed Models Analysis|mixed-model analysis with a repeated-measures approach including an unstructured variance matrix||Data analysis was based on the Intention-to-Treatment (ITT) method. Differences between the three intervention groups over time (baseline and 12 weeks) were assessed with a Group x Time interaction term. A priori comparisons of the active intervention groups with the waitlist group were carried out with the same strategy if analyses including all the three groups meet the criterion of statistical significance (P\<0.01).||||<0.01
72534838|NCT00694070|144598154|NON_INFERIORITY_OR_EQUIVALENCE|"The null and alternative hypotheses for these tests will have the form:~Ho: Pr{Success} \< Po vs. Ha: Pr{Success} ≥ Po. Critical values for numbers of successes were computed to give approximately a 90% chance of rejecting Ho in favor of the alternative (non-inferiority) if the true probability of success is at least Po. For Po = 80%, with n=51, critical number is 38. With this critical value and sample size, the power to reject Ho is approximately 87.43%."||||||0.0421|||||||Exact binomial test|||||||0.0421
72534839|NCT00694070|144598155|NON_INFERIORITY_OR_EQUIVALENCE|"The null and alternative hypotheses for these tests will have the form:~Ho: Pr{Success} \< Po vs. Ha: Pr{Success} ≥ Po. Critical values for numbers of successes were computed to give approximately a 90% chance of rejecting Ho in favor of the alternative (non-inferiority) if the true probability of success is at least Po. For Po = 95%, with n=51, critical number is 47. With this critical value and sample size, the power to reject Ho is approximately 88.96%."||||||0.0309|||||||Exact binomial test|||||||0.0309
72408210|NCT00673452|144324798|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|3.83|||<|0.001|TWO_SIDED|95.0|2.05|5.6||P-value for Mental Component Summary (MCS). The p-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is 0.05.|ANCOVA|Model: SF-36 subscale change from baseline at endpoint = SF-36 subscale at baseline + treatment + pooled investigator.|Least Squares Mean Difference = Duloxetine minus Placebo.|||5.60|2.05|<0.001
72534840|NCT00694070|144598156|NON_INFERIORITY_OR_EQUIVALENCE|"The null and alternative hypotheses for these tests will have the form:~Ho: Pr{Success} \< Po vs. Ha: Pr{Success} ≥ Po. Critical values for numbers of successes were computed to give approximately a 90% chance of rejecting Ho in favor of the alternative (non-inferiority) if the true probability of success is at least Po. For Po = 90%, with n=51, critical number is 43. With this critical value and sample size, the power to reject Ho is approximately 93.57%."||||||0.0309|||||||Exact binomial test|||||||0.0309
72534841|NCT00766727|144598157|SUPERIORITY||Mean Difference (Final Values)|-31.88|STANDARD_DEVIATION|14.25|||TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||
72534842|NCT03948646|144598163|OTHER||Odds Ratio (OR)|2.0||||0.0029|TWO_SIDED|95.0|1.27|3.15|||Regression, Logistic|||||3.15|1.27|0.0029
72534843|NCT03948646|144598164|OTHER||Mean Difference (Net)|-21.77|STANDARD_ERROR_OF_MEAN|9.994||0.0296|TWO_SIDED|95.0|-41.37|-2.16|||ANCOVA|||||-2.16|-41.37|0.0296
72534844|NCT00908375|144598176|NON_INFERIORITY_OR_EQUIVALENCE|Sample size was determined based on the primary outcome variable, the VAS pain score at three weeks. Based on the results of the study of Siddall et al., group sample sizes of 19 and 19 achieve 82% power to detect a difference of 2.00 between the null hypothesis that both group means are 6.50 and the alternative hypothesis that the mean of pregabalin group is 4.50 with estimated group standard deviations of 2.10 and 2.10 and with a significance level of 0.05 using a two-sided two-sample t-test.|Median Difference (Final Values)|-2.0||||0.279|TWO_SIDED|99.0|-6.0|3.0||The criterion for rejection of the null hypothesis (P \< 0.05) was adjusted for multiple application of the test to the same data set using the Bonferroni correction.|Wilcoxon (Mann-Whitney)|||||3|-6|0.279
72534845|NCT00908375|144598177|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-1.0||||0.282|TWO_SIDED|99.0|-2.0|1.0||The criterion for rejection of the null hypothesis (P \< 0.05) was adjusted for multiple applications of the test to the same data using the Bonferroni correction.|Wilcoxon (Mann-Whitney)|||||1.0|-2.0|0.282
72534846|NCT00908375|144598178|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-16.0||||0.139|TWO_SIDED|99.0|-42.0|16.0||The criterion for rejection of the null hypothesis (P \< 0.05) was adjusted for multiple applications of the test to the same data using the Bonferroni correction.|Wilcoxon (Mann-Whitney)|||||16|-42|0.139
72534847|NCT01298323|144598193|SUPERIORITY_OR_OTHER_LEGACY||t-Statistic|1.29||||0.199|TWO_SIDED|95.0|-3.44|16.37||Statistical significance threshold at this analysis was 10%|t-test, 2 sided|||||16.37|-3.44|0.199
72534848|NCT00931515|144598221|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||||||1.0
72534849|NCT01375491|144598267|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05||95.0||||See published paper.|ANOVA|See published paper.||See published paper.||||<0.05
72534850|NCT00463385|144598302|SUPERIORITY_OR_OTHER_LEGACY|||||||0.092||95.0|||||Fisher Exact|||||||0.092
72534851|NCT00463385|144598302|SUPERIORITY_OR_OTHER_LEGACY|||||||0.048||95.0|||||Fisher Exact|||||||0.048
72408211|NCT00673452|144324799|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.96||||0.083|TWO_SIDED|95.0|-2.05|0.13||A priori threshold for statistical significance is 0.05.|ANCOVA|Model: MGH-CPFQ change from baseline at endpoint = MGH-CPFQ baseline + treatment + pooled investigator.|Least Squares Mean Difference = Duloxetine minus Placebo.|||0.13|-2.05|0.083
72408212|NCT00673452|144324800|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.75|||<|0.001|TWO_SIDED|95.0|-1.18|-0.32||P-value for Mood. P-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is 0.05.|ANCOVA|Model: Likert scale change from baseline at endpoint = Likert scale baseline + treatment + pooled investigator.|Least Squares Mean Difference = Duloxetine minus Placebo.|||-0.32|-1.18|<0.001
72408213|NCT00673452|144324800|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.64||||0.003|TWO_SIDED|95.0|-1.05|-0.22||P-value for Anxiety. P-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is 0.05.|ANCOVA|Model: Likert scale change from baseline at endpoint = Likert scale baseline + treatment + pooled investigator.|Least Squares Mean Difference = Duloxetine minus Placebo.|||-0.22|-1.05|0.003
72408214|NCT00673452|144324800|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.72||||0.003|TWO_SIDED|95.0|-1.19|-0.25||P-value for Pain. P-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is 0.05.|ANCOVA|Model: Likert scale change from baseline at endpoint = Likert scale baseline + treatment + pooled investigator.|Least Squares Mean Difference = Duloxetine minus Placebo.|||-0.25|-1.19|0.003
72408215|NCT00673452|144324800|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.49||||0.05|TWO_SIDED|95.0|-0.97|0.0||P-value for Sleep. P-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is 0.05.|ANCOVA|Model: Likert scale change from baseline at endpoint = Likert scale baseline + treatment + pooled investigator.|Least Squares Mean Difference = Duloxetine minus Placebo.|||-0.00|-0.97|0.050
72534852|NCT00463385|144598302|SUPERIORITY_OR_OTHER_LEGACY|||||||0.758||95.0|||||Fisher Exact|||||||0.758
72534853|NCT01969201|144598329|NON_INFERIORITY|The non-inferiority was evaluated by calculating the 95% CI for the differences in pregnancy rates between the two treatment groups. If the lower bound of the 95% CI of the difference between the two proportions was greater than -0.10 (i.e. 10%), then Fostimon was to be considered not inferior to the control treatment.|Mean Difference (Final Values)|-2.73||||0.49|TWO_SIDED|95.0|-9.88|4.42|||Fisher Exact|||||4.42|-9.88|0.49
72534854|NCT01969201|144598330|OTHER|||||||0.003|||||||Wilcoxon (Mann-Whitney)|||||||0.003
72534855|NCT01969201|144598331|OTHER|||||||0.02|||||||ANOVA|||||||0.02
72534856|NCT01969201|144598332|OTHER|||||||0.32|||||||ANOVA|||||||0.32
72408216|NCT00673452|144324800|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.87|||<|0.001|TWO_SIDED|95.0|-1.32|-0.43||P-value for Stiffness. P-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is 0.05.|ANCOVA|Model: Likert scale change from baseline at endpoint = Likert scale baseline + treatment + pooled investigator.|Least Squares Mean Difference = Duloxetine minus Placebo.|||-0.43|-1.32|<0.001
72408217|NCT00673452|144324801|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||A priori threshold for statistical significance is 0.05.|Fisher Exact|||||||0.002
72534857|NCT01969201|144598333|OTHER|||||||0.89|||||||ANOVA|||||||0.89
72534858|NCT01969201|144598334|OTHER|||||||0.5|||||||Fisher Exact|||||||0.5
72534859|NCT01969201|144598335|OTHER|||||||0.53|||||||Fisher Exact|||||||0.53
72534860|NCT01969201|144598336|OTHER|||||||0.07|||||||Fisher Exact|||||||0.07
72534861|NCT01422876|144598350|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.58|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001|TWO_SIDED|95.0|-0.75|-0.41|||ANCOVA|||Model for Week 24 includes baseline HbA1c (p\<0.0001) as linear covariate(s) and baseline eGFR (MDRD) (p=0.0038), geographical region (p\<0.0001), treatment (p\<0.0001) as fixed effect(s).||-0.41|-0.75|<0.0001
72534862|NCT01422876|144598350|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.5|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001|TWO_SIDED|95.0|-0.67|-0.32|||ANCOVA|||Model for Week 24 includes baseline HbA1c (p\<0.0001) as linear covariate(s) and baseline eGFR (MDRD) (p=0.0038), geographical region (p\<0.0001), treatment (p\<0.0001) as fixed effect(s).||-0.32|-0.67|<0.0001
72534863|NCT01422876|144598350|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.42|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001|TWO_SIDED|95.0|-0.59|-0.25|||ANCOVA|||Model for Week 24 includes baseline HbA1c (p\<0.0001) as linear covariate(s) and baseline eGFR (MDRD) (p=0.0038), geographical region (p\<0.0001), treatment (p\<0.0001) as fixed effect(s).||-0.25|-0.59|<0.0001
72534864|NCT01422876|144598350|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.39|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001|TWO_SIDED|95.0|-0.56|-0.21|||ANCOVA|||Model for Week 24 includes baseline HbA1c (p\<0.0001) as linear covariate(s) and baseline eGFR (MDRD) (p=0.0038), geographical region (p\<0.0001), treatment (p\<0.0001) as fixed effect(s).||-0.21|-0.56|<0.0001
72534865|NCT01422876|144598351|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-16.43|STANDARD_ERROR_OF_MEAN|3.54|<|0.0001|TWO_SIDED|95.0|-23.37|-9.48|||ANCOVA|||Model for Week 24 includes baseline fasting plasma glucose (p\<0.0001), baseline HbA1c (p=0.6082) as linear covariate(s) and baseline eGFR (MDRD) (p=0.3685), geographical region (p=0.0104), treatment (p\<0.0001) as fixed effect(s).||-9.48|-23.37|<0.0001
72534866|NCT01422876|144598351|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-22.2|STANDARD_ERROR_OF_MEAN|3.62|<|0.0001|TWO_SIDED|95.0|-29.3|-15.1|||ANCOVA|||Model for Week 24 includes baseline fasting plasma glucose (p\<0.0001), baseline HbA1c (p=0.6082) as linear covariate(s) and baseline eGFR (MDRD) (p=0.3685), geographical region (p=0.0104), treatment (p\<0.0001) as fixed effect(s).||-15.10|-29.30|<0.0001
72534867|NCT01422876|144598351|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-11.34|STANDARD_ERROR_OF_MEAN|3.55||0.0015|TWO_SIDED|95.0|-18.31|-4.37|||ANCOVA|||Model for Week 24 includes baseline fasting plasma glucose (p\<0.0001), baseline HbA1c (p=0.6082) as linear covariate(s) and baseline eGFR (MDRD) (p=0.3685), geographical region (p=0.0104), treatment (p\<0.0001) as fixed effect(s).||-4.37|-18.31|0.0015
72534868|NCT01422876|144598351|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-19.12|STANDARD_ERROR_OF_MEAN|3.61|<|0.0001|TWO_SIDED|95.0|-26.21|-12.03|||ANCOVA|||Model for Week 24 includes baseline fasting plasma glucose (p\<0.0001), baseline HbA1c (p=0.6082) as linear covariate(s) and baseline eGFR (MDRD) (p=0.3685), geographical region (p=0.0104), treatment (p\<0.0001) as fixed effect(s).||-12.03|-26.21|<0.0001
72534869|NCT01422876|144598352|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.31|STANDARD_ERROR_OF_MEAN|3.78||0.1605|TWO_SIDED|95.0|-12.74|2.11|||ANCOVA|||Model for Week 24 includes baseline fasting plasma glucose (p\<0.0001), baseline HbA1c (p=0.4591) as linear covariate(s) and baseline eGFR (MDRD) (p=0.7413), geographical region (p=0.1504), treatment (p\<0.0001) as fixed effect(s).||2.11|-12.74|0.1605
72572752|NCT00593736|144672820|SUPERIORITY_OR_OTHER|||||||0.194||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.194
72572753|NCT00593736|144672820|SUPERIORITY_OR_OTHER|||||||0.134||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.134
72572754|NCT00593736|144672820|SUPERIORITY_OR_OTHER|||||||0.13||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.130
72572755|NCT00593736|144672821|SUPERIORITY_OR_OTHER|||||||0.063||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.063
72572756|NCT00593736|144672821|SUPERIORITY_OR_OTHER|||||||0.156||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.156
72572757|NCT00593736|144672821|SUPERIORITY_OR_OTHER|||||||0.521||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.521
72572758|NCT00593736|144672822|SUPERIORITY_OR_OTHER|||||||0.675||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.675
72572759|NCT00593736|144672822|SUPERIORITY_OR_OTHER|||||||0.566||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.566
72572760|NCT00593736|144672822|SUPERIORITY_OR_OTHER|||||||0.205||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.205
72572761|NCT00593736|144672823|SUPERIORITY_OR_OTHER|||||||0.643||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.643
72572762|NCT00593736|144672823|SUPERIORITY_OR_OTHER|||||||0.032||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.032
72572763|NCT00593736|144672823|SUPERIORITY_OR_OTHER|||||||0.875||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.875
72572764|NCT00593736|144672824|SUPERIORITY_OR_OTHER|||||||0.286||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.286
72572765|NCT00593736|144672824|SUPERIORITY_OR_OTHER|||||||0.318||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.318
72572766|NCT00593736|144672824|SUPERIORITY_OR_OTHER|||||||0.483||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.483
72572767|NCT00593736|144672825|SUPERIORITY_OR_OTHER|||||||0.04||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.040
72572768|NCT00593736|144672825|SUPERIORITY_OR_OTHER|||||||0.61||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.610
72572769|NCT00593736|144672825|SUPERIORITY_OR_OTHER|||||||0.368||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.368
72572770|NCT00593736|144672826|SUPERIORITY_OR_OTHER|||||||0.352||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.352
72408218|NCT00673452|144324802|SUPERIORITY_OR_OTHER|||||||0.003||95.0||||A priori threshold for statistical significance is 0.05.|Fisher Exact|||||||0.003
72572771|NCT00593736|144672826|SUPERIORITY_OR_OTHER|||||||0.86||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.860
72572772|NCT00593736|144672826|SUPERIORITY_OR_OTHER|||||||0.297||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.297
72572773|NCT00593736|144672827|SUPERIORITY_OR_OTHER|||||||0.053||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.053
72572774|NCT00593736|144672827|SUPERIORITY_OR_OTHER|||||||0.837||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.837
72572775|NCT00593736|144672827|SUPERIORITY_OR_OTHER|||||||0.783||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.783
72572776|NCT00593736|144672828|SUPERIORITY_OR_OTHER|||||||0.566||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.566
72572777|NCT00593736|144672828|SUPERIORITY_OR_OTHER|||||||0.543||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.543
72572778|NCT00593736|144672828|SUPERIORITY_OR_OTHER|||||||0.847||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.847
72572779|NCT00593736|144672829|SUPERIORITY_OR_OTHER|||||||0.356||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.356
72572780|NCT00593736|144672829|SUPERIORITY_OR_OTHER|||||||0.964||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.964
72572781|NCT00593736|144672829|SUPERIORITY_OR_OTHER|||||||0.799||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.799
72572782|NCT00593736|144672830|SUPERIORITY_OR_OTHER|||||||0.698||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.698
72572783|NCT00593736|144672830|SUPERIORITY_OR_OTHER|||||||0.385||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.385
72572784|NCT00593736|144672830|SUPERIORITY_OR_OTHER|||||||0.641||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.641
72572785|NCT00593736|144672831|SUPERIORITY_OR_OTHER|||||||0.979||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.979
72572786|NCT00593736|144672831|SUPERIORITY_OR_OTHER|||||||0.194||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.194
72572787|NCT00593736|144672831|SUPERIORITY_OR_OTHER|||||||0.004||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.004
72572788|NCT00593736|144672832|SUPERIORITY_OR_OTHER|||||||0.975||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.975
72572789|NCT00593736|144672832|SUPERIORITY_OR_OTHER|||||||0.639||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.639
72572790|NCT00593736|144672832|SUPERIORITY_OR_OTHER|||||||0.109||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.109
72572791|NCT00593736|144672833|SUPERIORITY_OR_OTHER|||||||0.823||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.823
72572792|NCT00593736|144672833|SUPERIORITY_OR_OTHER|||||||0.004||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.004
72572793|NCT00593736|144672833|SUPERIORITY_OR_OTHER|||||||0.296||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.296
72572794|NCT00593736|144672834|SUPERIORITY_OR_OTHER|||||||0.092||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.092
72572795|NCT00593736|144672834|SUPERIORITY_OR_OTHER|||||||0.025||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.025
72572796|NCT00593736|144672834|SUPERIORITY_OR_OTHER|||||||0.732||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.732
72572797|NCT00593736|144672835|SUPERIORITY_OR_OTHER|||||||0.298||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.298
72408219|NCT00673452|144324803|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|1.82||||0.084|TWO_SIDED|95.0|-0.25|3.88||P-value for Systolic Blood Pressure (SBP). A priori threshold for statistical significance is 0.05.|ANCOVA|Model: Change = baseline + treatment + pooled investigator.|Least Squares Mean Difference = Duloxetine minus Placebo.|||3.88|-0.25|0.084
72408220|NCT00673452|144324803|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.52||||0.434|TWO_SIDED|95.0|-0.79|1.84||P-value for Diastolic Blood Pressure (DBP). A priori threshold for statistical significance is 0.05.|ANCOVA|Model: Change = baseline + treatment + pooled investigator.|Least Squares Mean Difference = Duloxetine minus Placebo.|||1.84|-0.79|0.434
72572798|NCT00593736|144672835|SUPERIORITY_OR_OTHER|||||||0.276||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.276
72572799|NCT00593736|144672835|SUPERIORITY_OR_OTHER|||||||0.43||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.430
72626558|NCT01576783|144781966|OTHER|The reported p-value is for the comparison of the change in Cognitive Composite scores between groups (DHA+AA vs. Placebo).||||||0.66||||||Threshold for statistical significance (\<0.05)|Mixed Models Analysis|Analyses compared the change in scores between groups, using mixed effects regression that leveraged maximum likelihood to include missing data.||A sample of 448 was planned to achieve \>80% power to detect a 4.2-point difference (0.27-standard deviation (SD)) in Bayley-III cognitive composite scores with 10% loss to follow-up.The investigational product manufacturer discontinued production once 377 were enrolled, thereby capping enrollment. That sample provided 80% power to detect a 0.29-SD difference in Bayley-III scores.||||.66
72626559|NCT01576783|144781966|OTHER|The reported p-value is for the comparison of the change in Language Composite scores between groups (DHA+AA vs. Placebo).||||||0.55||||||Threshold for statistical significance (\<0.05)|Mixed Models Analysis|Analyses compared the change in scores between groups, using mixed effects regression that leveraged maximum likelihood to include missing data.||A sample of 448 was planned to achieve \>80% power to detect a 4.2-point difference (0.27-standard deviation (SD)) in Bayley-III cognitive composite scores with 10% loss to follow-up.The investigational product manufacturer discontinued production once 377 were enrolled, thereby capping enrollment. That sample provided 80% power to detect a 0.29-SD difference in Bayley-III scores.||||.55
72408221|NCT00673452|144324804|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|1.96||||0.003|TWO_SIDED|95.0|0.67|3.26||A priori threshold for statistical significance is 0.05.|ANCOVA|Model: Change = baseline + treatment + pooled investigator.|Least Squares Mean Difference = Duloxetine minus Placebo.|||3.26|0.67|0.003
72408222|NCT00673452|144324805|SUPERIORITY_OR_OTHER|||||||1||95.0||||P-value for Suicidal Ideation. A priori threshold for statistical significance is 0.05.|Fisher Exact|||||||1.00
72572800|NCT00593736|144672836|SUPERIORITY_OR_OTHER|||||||0.349||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.349
72572801|NCT00593736|144672836|SUPERIORITY_OR_OTHER|||||||0.203||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.203
72408223|NCT00673452|144324806|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.83|||<|0.001|TWO_SIDED|95.0|-1.21|-0.45||A priori threshold for statistical significance is 0.05.|ANCOVA|Model: Change = baseline + treatment + pooled investigator.|Least Squares Mean Difference = Duloxetine minus Placebo.|||-0.45|-1.21|<0.001
72572802|NCT00593736|144672836|SUPERIORITY_OR_OTHER|||||||0.444||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.444
72572803|NCT00593736|144672837|SUPERIORITY_OR_OTHER|||||||0.581||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.581
72572804|NCT00593736|144672837|SUPERIORITY_OR_OTHER|||||||0.257||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.257
72572805|NCT00593736|144672837|SUPERIORITY_OR_OTHER|||||||0.688||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.688
72572806|NCT00593736|144672838|SUPERIORITY_OR_OTHER|||||||0.561||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.561
72572807|NCT00593736|144672838|SUPERIORITY_OR_OTHER|||||||0.595||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.595
72572808|NCT00593736|144672838|SUPERIORITY_OR_OTHER|||||||0.795||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.795
72628218|NCT00492557|144784517|NON_INFERIORITY_OR_EQUIVALENCE|The criterion upon which to declare non-inferiority was if the lower limit of the 2-sided 95%CI for the GMT ratios, (13vPnC+TIV relative to 13vPnC administered 1 month after TIV+placebo) was greater than 0.5 (2-fold criterion).|GMT Ratio|1.1|||||TWO_SIDED|95.0|0.77|1.6|||||2-sided 95% CIs for the GMT ratio were calculated by back transformations of the 95% CIs based on the Student t distribution for the mean difference of the logarithmically transformed assay results.|Serotype 5. The primary null hypothesis was: the log of the GMT in the group receiving 13vPnC + TIV minus the log of the GMT in the group receiving 13vPnC alone (1 month after TIV) \<= -0.693.||1.60|0.77|
72408224|NCT03254134|144324823|SUPERIORITY||Hazard Ratio (HR)|0.72|||||TWO_SIDED|95.0|0.534|0.97||||||There was no formal hypothesis testing.|The hazard ratio of stroke for the dabigatran group as compared to the warfarin group and its 95% CI were estimated from the propensity score matched group using a Cox regression model with treatment group as the dependent variable|0.970|0.534|
72572809|NCT00593736|144672839|SUPERIORITY_OR_OTHER|||||||0.655||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.655
72572810|NCT00593736|144672839|SUPERIORITY_OR_OTHER|||||||0.177||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.177
72572811|NCT00593736|144672839|SUPERIORITY_OR_OTHER|||||||0.044||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.044
72408225|NCT03254134|144324824|SUPERIORITY||Hazard Ratio (HR)|0.549|||||TWO_SIDED|95.0|0.303|0.994||||||There was no formal hypothesis testing.|The hazard ratio of systemic embolism for the dabigatran group as compared to the warfarin group and its 95% CI were estimated from the propensity score matched group using a Cox regression model with treatment group as the dependent variable|0.994|0.303|
72408226|NCT00378703|144324829|SUPERIORITY_OR_OTHER|||||||0.89|TWO_SIDED||||||Log Rank|||Progression-free survival was compared between Arm B (bevacizumab and temsirolimus) and Arm A (bevacizumab alone) using stratified log rank test, stratified on prior cytokine or vaccine therapy and risk category (low/intermediate/high risk)||||0.89
72572812|NCT00593736|144672840|SUPERIORITY_OR_OTHER|||||||0.475||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.475
72572813|NCT00593736|144672840|SUPERIORITY_OR_OTHER|||||||0.635||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.635
72572814|NCT00593736|144672840|SUPERIORITY_OR_OTHER|||||||0.782||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.782
72572815|NCT00593736|144672841|SUPERIORITY_OR_OTHER|||||||0.192||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.192
72534870|NCT01422876|144598352|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.82|STANDARD_ERROR_OF_MEAN|3.78||0.1246|TWO_SIDED|95.0|-13.25|1.61|||ANCOVA|||Model for Week 24 includes baseline fasting plasma glucose (p\<0.0001), baseline HbA1c (p=0.4591) as linear covariate(s) and baseline eGFR (MDRD) (p=0.7413), geographical region (p=0.1504), treatment (p\<0.0001) as fixed effect(s).||1.61|-13.25|0.1246
72572816|NCT00593736|144672841|SUPERIORITY_OR_OTHER|||||||0.618||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.618
72572817|NCT00593736|144672841|SUPERIORITY_OR_OTHER|||||||0.152||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.152
72572818|NCT00593736|144672842|SUPERIORITY_OR_OTHER|||||||0.379||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.379
72572819|NCT00593736|144672842|SUPERIORITY_OR_OTHER|||||||0.057||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.057
72572820|NCT00593736|144672842|SUPERIORITY_OR_OTHER|||||||0.808||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.808
72572821|NCT00593736|144672843|SUPERIORITY_OR_OTHER|||||||0.284||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.284
72534871|NCT01422876|144598352|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-23.63|STANDARD_ERROR_OF_MEAN|3.78|<|0.0001|TWO_SIDED|95.0|-31.06|-16.21|||ANCOVA|||Model for Week 24 includes baseline fasting plasma glucose (p\<0.0001), baseline HbA1c (p=0.4591) as linear covariate(s) and baseline eGFR (MDRD) (p=0.7413), geographical region (p=0.1504), treatment (p\<0.0001) as fixed effect(s).||-16.21|-31.06|<0.0001
72534872|NCT01422876|144598352|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-22.29|STANDARD_ERROR_OF_MEAN|3.77|<|0.0001|TWO_SIDED|95.0|-29.71|-14.88|||ANCOVA|||Model for Week 24 includes baseline fasting plasma glucose (p\<0.0001), baseline HbA1c (p=0.4591) as linear covariate(s) and baseline eGFR (MDRD) (p=0.7413), geographical region (p=0.1504), treatment (p\<0.0001) as fixed effect(s).||-14.88|-29.71|<0.0001
72572822|NCT00593736|144672843|SUPERIORITY_OR_OTHER|||||||0.344||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.344
72572823|NCT00593736|144672843|SUPERIORITY_OR_OTHER|||||||0.558||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.558
72572824|NCT00593736|144672844|SUPERIORITY_OR_OTHER|||||||0.867||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.867
72572825|NCT00593736|144672844|SUPERIORITY_OR_OTHER|||||||0.244||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.244
72408227|NCT00378703|144324829|SUPERIORITY_OR_OTHER|||||||0.54|TWO_SIDED||||||Log Rank|||Progression-free survival was compared between Arm C (bevacizumab and sorafenib) and Arm A (bevacizumab alone) using stratified log rank test, stratified on prior cytokine or vaccine therapy and risk category (low/intermediate/high risk).||||0.54
72572826|NCT00593736|144672844|SUPERIORITY_OR_OTHER|||||||0.62||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.620
72572827|NCT00593736|144672845|SUPERIORITY_OR_OTHER|||||||0.206||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.206
72572828|NCT00593736|144672845|SUPERIORITY_OR_OTHER|||||||0.559||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.559
72534873|NCT01422876|144598353|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.19|STANDARD_ERROR_OF_MEAN|0.43||0.6604|TWO_SIDED|95.0|-0.65|1.03||Not an alpha protected test.|ANCOVA|||Model for Week 24 includes baseline weight (p\<0.0001), baseline HbA1c (p=0.1610) as linear covariate(s) and baseline eGFR (MDRD) (p=0.3685), geographical region (p=0.0162), treatment (p\<0.0001) as fixed effect(s).||1.03|-0.65|0.6604
72572829|NCT00593736|144672845|SUPERIORITY_OR_OTHER|||||||0.074||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.074
72572830|NCT00593736|144672846|SUPERIORITY_OR_OTHER|||||||0.796||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.796
72572831|NCT00593736|144672846|SUPERIORITY_OR_OTHER|||||||0.546||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.546
72572832|NCT00593736|144672846|SUPERIORITY_OR_OTHER|||||||0.479||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.479
72572833|NCT00593736|144672847|SUPERIORITY_OR_OTHER|||||||0.766||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.766
72572834|NCT00593736|144672847|SUPERIORITY_OR_OTHER|||||||0.912||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.912
72626560|NCT01576783|144781966|OTHER|The reported p-value is for the comparison of the change in Motor Composite scores between groups (DHA+AA vs. Placebo).||||||0.88||||||Threshold for statistical significance (\<0.05)|Mixed Models Analysis|Analyses compared the change in scores between groups, using mixed effects regression that leveraged maximum likelihood to include missing data.||A sample of 448 was planned to achieve \>80% power to detect a 4.2-point difference (0.27-standard deviation (SD)) in Bayley-III cognitive composite scores with 10% loss to follow-up.The investigational product manufacturer discontinued production once 377 were enrolled, thereby capping enrollment. That sample provided 80% power to detect a 0.29-SD difference in Bayley-III scores.||||.88
72626561|NCT01576783|144781967|OTHER|The reported p-value is for the comparison of the change in Nocturnal Sleep Duration between groups (DHA+AA vs. Placebo).||||||0.11||||||Threshold for statistical significance (\<0.05).|Mixed Models Analysis|Analyses compared the change in scores between groups, using mixed effects regression that leveraged maximum likelihood to include missing data.||||||.11
72626562|NCT01576783|144781967|OTHER|The reported p-value is for the comparison of the change in daytime sleep duration between groups (DHA+AA vs. Placebo).||||||0.47||||||Threshold for statistical significance (\<0.05).|Mixed Models Analysis|Analyses compared the change in scores between groups, using mixed effects regression that leveraged maximum likelihood to include missing data.||||||0.47
72626563|NCT01576783|144781967|OTHER|The reported p-value is for the comparison of the change in total sleep duration between groups (DHA+AA vs. Placebo).||||||0.32||||||Threshold for statistical significance (\<0.05).|Mixed Models Analysis|Analyses compared the change in scores between groups, using mixed effects regression that leveraged maximum likelihood to include missing data.||||||0.32
72408228|NCT00378703|144324829|SUPERIORITY_OR_OTHER|||||||0.68|TWO_SIDED||||||Log Rank|||Progression-free survival was compared between Arm D (sorafenib and temsirolimus) and Arm A (bevacizumab alone) using stratified log rank test, stratified on prior cytokine or vaccine therapy and risk category (low/intermediate/high risk).||||0.68
72572835|NCT00593736|144672847|SUPERIORITY_OR_OTHER|||||||0.952||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.952
72572836|NCT00593736|144672848|SUPERIORITY_OR_OTHER|||||||0.722||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.722
72572837|NCT00593736|144672848|SUPERIORITY_OR_OTHER|||||||0.262||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.262
72626564|NCT01576783|144781968|OTHER|The reported p-value is for the comparison of the change in weight-for-age z scores between groups (DHA+AA vs. Placebo).||||||0.99||||||Threshold for statistical significance (\<0.05)|Mixed Models Analysis|Analyses compared the change in scores between groups, using mixed-effects regression that leveraged maximum likelihood to account for missing data.||||||0.99
72572838|NCT00593736|144672848|SUPERIORITY_OR_OTHER|||||||0.717||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.717
72572839|NCT00593736|144672849|SUPERIORITY_OR_OTHER|||||||0.498||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.498
72572840|NCT00593736|144672849|SUPERIORITY_OR_OTHER|||||||0.664||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.664
72534874|NCT01422876|144598353|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.3|STANDARD_ERROR_OF_MEAN|0.44|<|0.0001|TWO_SIDED|95.0|-3.15|-1.44|||ANCOVA|||Model for Week 24 includes baseline weight (p\<0.0001), baseline HbA1c (p=0.1610) as linear covariate(s) and baseline eGFR (MDRD) (p=0.3685), geographical region (p=0.0162), treatment (p\<0.0001) as fixed effect(s).||-1.44|-3.15|<0.0001
72534875|NCT01422876|144598353|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.07|STANDARD_ERROR_OF_MEAN|0.43||0.8757|TWO_SIDED|95.0|-0.91|0.77||Not an alpha protected test.|ANCOVA|||Model for Week 24 includes baseline weight (p\<0.0001), baseline HbA1c (p=0.1610) as linear covariate(s) and baseline eGFR (MDRD) (p=0.3685), geographical region (p=0.0162), treatment (p\<0.0001) as fixed effect(s).||0.77|-0.91|0.8757
72534876|NCT01422876|144598353|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.91|STANDARD_ERROR_OF_MEAN|0.44|<|0.0001|TWO_SIDED|95.0|-2.77|-1.05|||ANCOVA|||Model for Week 24 includes baseline weight (p\<0.0001), baseline HbA1c (p=0.1610) as linear covariate(s) and baseline eGFR (MDRD) (p=0.3685), geographical region (p=0.0162), treatment (p\<0.0001) as fixed effect(s).||-1.05|-2.77|<0.0001
72534877|NCT01422876|144598354|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.14|STANDARD_ERROR_OF_MEAN|0.1||0.1785|TWO_SIDED|95.0|-0.33|0.06|||ANCOVA|||Model for Week 24 includes baseline HbA1c (p\<0.0001) as linear covariate(s) and baseline eGFR (MDRD) (p=0.8627), geographical region (p=0.0008), treatment (p\<0.0001) as fixed effect(s).||0.06|-0.33|0.1785
72534878|NCT01422876|144598354|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.41|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001|TWO_SIDED|95.0|-0.61|-0.21|||ANCOVA|||Model for Week 24 includes baseline HbA1c (p\<0.0001) as linear covariate(s) and baseline eGFR (MDRD) (p=0.8627), geographical region (p=0.0008), treatment (p\<0.0001) as fixed effect(s).||-0.21|-0.61|<0.0001
72534879|NCT01422876|144598354|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.41|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001|TWO_SIDED|95.0|-0.61|-0.22|||Cochran-Mantel-Haenszel|||Model for Week 24 includes baseline HbA1c (p\<0.0001) as linear covariate(s) and baseline eGFR (MDRD) (p=0.8627), geographical region (p=0.0008), treatment (p\<0.0001) as fixed effect(s).||-0.22|-0.61|<0.0001
72534880|NCT01422876|144598354|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.57|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001|TWO_SIDED|95.0|-0.76|-0.37|||ANCOVA|||Model for Week 24 includes baseline HbA1c (p\<0.0001) as linear covariate(s) and baseline eGFR (MDRD) (p=0.8627), geographical region (p=0.0008), treatment (p\<0.0001) as fixed effect(s).||-0.37|-0.76|<0.0001
72534881|NCT01422876|144598355|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.13|STANDARD_ERROR_OF_MEAN|0.51||0.801|TWO_SIDED|95.0|-0.88|1.14||Not an alpha protected test.|ANCOVA|||Model for Week 24 includes baseline weight (p\<0.0001), baseline HbA1c (p=0.0023) as linear covariate(s) and baseline eGFR (MDRD) (p=0.0316), geographical region (p=0.0134), treatment (p=0.0031) as fixed effect(s).||1.14|-0.88|0.8010
72534882|NCT01422876|144598355|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.47|STANDARD_ERROR_OF_MEAN|0.51||0.3616|TWO_SIDED|95.0|-1.48|0.54||Not an alpha protected test.|ANCOVA|||Model for Week 24 includes baseline weight (p\<0.0001), baseline HbA1c (p=0.0023) as linear covariate(s) and baseline eGFR (MDRD) (p=0.0316), geographical region (p=0.0134), treatment (p=0.0031) as fixed effect(s).||0.54|-1.48|0.3616
72534883|NCT01422876|144598355|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.22|STANDARD_ERROR_OF_MEAN|0.51||0.0178|TWO_SIDED|95.0|-2.23|-0.21|||ANCOVA|||Model for Week 24 includes baseline weight (p\<0.0001), baseline HbA1c (p=0.0023) as linear covariate(s) and baseline eGFR (MDRD) (p=0.0316), geographical region (p=0.0134), treatment (p=0.0031) as fixed effect(s).||-0.21|-2.23|0.0178
72534884|NCT01422876|144598355|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.96|STANDARD_ERROR_OF_MEAN|0.51||0.0001|TWO_SIDED|95.0|-2.97|-0.95|||ANCOVA|||Model for Week 24 includes baseline weight (p\<0.0001), baseline HbA1c (p=0.0023) as linear covariate(s) and baseline eGFR (MDRD) (p=0.0316), geographical region (p=0.0134), treatment (p=0.0031) as fixed effect(s).||-0.95|-2.97|0.0001
72534885|NCT01422876|144598356|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.191|||<|0.0001|TWO_SIDED|95.0|2.319|7.573|||Regression, Logistic|||Logistic regression includes treatment, baseline eGFR (MDRD), geographical region and baseline HbA1c.||7.573|2.319|<0.0001
72534886|NCT01422876|144598356|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.5|||<|0.0001|TWO_SIDED|95.0|2.474|8.184|||Regression, Logistic|||Logistic regression includes treatment, baseline eGFR (MDRD), geographical region and baseline HbA1c.||8.184|2.474|<0.0001
72534887|NCT01422876|144598356|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.495|||<|0.0001|TWO_SIDED|95.0|1.92|6.363|||Regression, Logistic|||Logistic regression includes treatment, baseline eGFR (MDRD), geographical region and baseline HbA1c.||6.363|1.920|<0.0001
72534888|NCT01422876|144598356|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.795||||0.0005|TWO_SIDED|95.0|1.562|5.001|||Regression, Logistic|||Logistic regression includes treatment, baseline eGFR (MDRD), geographical region and baseline HbA1c.||5.001|1.562|0.0005
72534889|NCT01422876|144598357|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.893||||0.0224|TWO_SIDED|95.0|1.095|3.274|||Regression, Logistic|||Logistic regression includes treatment, baseline eGFR (MDRD), geographical region and baseline HbA1c.||3.274|1.095|0.0224
72534890|NCT01422876|144598357|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.961||||0.0001|TWO_SIDED|95.0|1.697|5.169|||Regression, Logistic|||Logistic regression includes treatment, baseline eGFR (MDRD), geographical region and baseline HbA1c.||5.169|1.697|0.0001
72534891|NCT01422876|144598357|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.065|||<|0.0001|TWO_SIDED|95.0|1.768|5.314|||Regression, Logistic|||Logistic regression includes treatment, baseline eGFR (MDRD), geographical region and baseline HbA1c.||5.314|1.768|<0.0001
72534892|NCT01422876|144598357|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.303|||<|0.0001|TWO_SIDED|95.0|2.462|7.522|||Regression, Logistic|||Logistic regression includes treatment, baseline eGFR (MDRD), geographical region and baseline HbA1c.||7.522|2.462|<0.0001
72534893|NCT01366846|144598388|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Chi-squared|||Comparison of the percentage of subjects with peanut allergy in the Continued Peanut Avoidance Group to that of the Peanut Avoidance After Peanut Consumption Group within the SPT-negative stratum.||||<0.001
72534894|NCT01366846|144598388|SUPERIORITY_OR_OTHER|||||||0.004|||||||Chi-squared|||Comparison of the percentage of subjects with peanut allergy in the Continued Peanut Avoidance Group to that of the Peanut Avoidance After Peanut Consumption Group within the SPT-positive stratum.||||0.004
72534895|NCT01366846|144598389|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Chi-squared|||Comparison of the percentage of participants with peanut allergy in the Continued Peanut Avoidance Group to that of the Peanut Consumption Group across both the SPT-negative and SPT-positive strata.||||<0.001
72534896|NCT01366846|144598390|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Chi-squared|||Comparison of the percentage of subjects with peanut allergy in the Continued Peanut Avoidance Group to that of the Peanut Avoidance After Peanut Consumption Group within the SPT-negative stratum.||||<0.001
72534897|NCT01366846|144598390|SUPERIORITY_OR_OTHER|||||||0.027|||||||Chi-squared|||Comparison of the percentage of subjects with peanut allergy in the Continued Peanut Avoidance Group to that of the Peanut Avoidance After Peanut Consumption Group within the SPT-positive stratum.||||0.027
72534898|NCT01366846|144598391|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Chi-squared|||Comparison of the percentage of subjects with peanut allergy in the Continued Peanut Avoidance Group to that of the Peanut Avoidance After Peanut Consumption Group across both the SPT-negative and SPT-positive strata.||||<0.001
72534899|NCT01366846|144598392|SUPERIORITY_OR_OTHER|||||||0.25|||||||Exact McNemar|||Comparison of the percentage of subjects with peanut allergy in the Peanut Avoidance After Peanut Consumption Group at month 60 to that of the Peanut Avoidance After Peanut Consumption Group at month 72 across both the SPT-negative and SPT-positive strata.||||0.250
72534900|NCT01366846|144598393|SUPERIORITY_OR_OTHER|||||||0.25|||||||Exact McNemar|||Comparison of the percentage of subjects with peanut allergy in the Peanut Avoidance After Peanut Consumption Group at month 60 to that of the Peanut Avoidance After Peanut Consumption Group at month 72 across both the SPT-negative and SPT-positive strata.||||0.250
72534901|NCT01283009|144598573|SUPERIORITY||Odds Ratio (OR)|0.9||||0.635|TWO_SIDED|95.0|0.58|1.4|||Mantel Haenszel|||||1.40|0.58|0.635
72534902|NCT04436497|144598574|SUPERIORITY||Disease Rate Ratio|1.08|STANDARD_DEVIATION|0.11|||TWO_SIDED|95.0|0.874|1.307||Posterior probability that the disease rate ratio (DRR) is less than 1 (i.e. zilucoplan slowed progression) was 0.2418. NOTE: p-value is not provided for Bayesian model.|Bayesian shared-parameter model|A Bayesian shared-parameter model of change in disease severity as measured by ALSFRS-R total score and mortality.|"DDR \<1 imply slowing of disease progression by zilucoplan relative to placebo. Note: reported Confidence Interval is actually a Bayesian credible interval."||The DRR parameter for active treatment represents the relative change to the rate of decline of ALSFRS-R and the rate of mortality of treated participant relative to a placebo participant. The estimated DRR can also be interpreted as the average rate of decline in function and mortality. The model includes covariates for baseline use of edaravone, baseline use of riluzole, months since onset of symptoms, and pre-baseline slope of ALSFRS-R, and random effects for regimen and participant-specific slopes.|1.307|0.874|
72534903|NCT04436497|144598576|SUPERIORITY||Mean Difference (Net)|-1.09|STANDARD_ERROR_OF_MEAN|1.819||0.5495|TWO_SIDED|95.0|-4.66|2.48|||Mixed Models Analysis|Covariates include baseline use of edaravone and riluzole, months since symptom onset, and pre-baseline ALSFRS-R slope.|Zilucoplan 24-week change from baseline relative to placebo 24-week change from baseline.|||2.48|-4.66|0.5495
72534904|NCT04436497|144598577|SUPERIORITY||Mean Difference (Net)|-1.04|STANDARD_ERROR_OF_MEAN|3.409||0.7602|TWO_SIDED|95.0|-7.73|5.65|||Mixed Models Analysis|Covariates include baseline use of edaravone and riluzole, months since symptom onset, and pre-baseline ALSFRS-R slope.|Zilucoplan 24-week change from baseline relative to placebo 24-week change from baseline.|||5.65|-7.73|0.7602
72534905|NCT04436497|144598578|SUPERIORITY|||||||0.6891|||||||Log Rank|||||||0.6891
72534906|NCT00505765|144598580|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.9|STANDARD_DEVIATION|1.5||0.21|TWO_SIDED||||||ANCOVA|||||||0.21
72534907|NCT00505765|144598580|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.2|STANDARD_DEVIATION|1.5||0.44|TWO_SIDED||||||ANCOVA|||||||0.44
72534908|NCT04640168|144598585|SUPERIORITY|||||||0.909|||||||Chi-squared|||||||0.909
72534909|NCT04640168|144598602|SUPERIORITY||Risk Difference (RD)|7.7|||||TWO_SIDED|95.0|1.8|13.4||||||||13.4|1.8|
72534910|NCT04640168|144598603|SUPERIORITY||Risk Difference (RD)|0.6|||||TWO_SIDED|95.0|-4.3|5.5||||||||5.5|-4.3|
72534911|NCT04640168|144598621|SUPERIORITY||Odds Ratio (OR)|1.01|||||TWO_SIDED|95.0|0.8|1.27||||||||1.27|0.80|
72534912|NCT04640168|144598622|SUPERIORITY||Risk Difference (RD)|-0.03|||||TWO_SIDED|95.0|-0.09|0.02||||||||0.02|-0.09|
72534913|NCT04640168|144598623|SUPERIORITY||Hazard Ratio (HR)|1.08|||||TWO_SIDED|95.0|0.94|1.23||||||||1.23|0.94|
72534914|NCT04640168|144598624|SUPERIORITY||Hazard Ratio (HR)|1.08|||||TWO_SIDED|95.0|0.94|1.23||||||||1.23|0.94|
72534915|NCT04640168|144598625|SUPERIORITY||Hazard Ratio (HR)|1.04|||||TWO_SIDED|95.0|0.91|1.19||||||||1.19|0.91|
72534916|NCT00276458|144598678|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-19.9|STANDARD_ERROR_OF_MEAN|2.7|<|0.001||95.0|-25.2|-14.5|||ANCOVA|Model terms: treatment and baseline LDL-C value|(Atorva + EZ minus Atorva)|||-14.5|-25.2|<0.001
72534917|NCT00276458|144598679|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.4|STANDARD_ERROR_OF_MEAN|2.1||0.273||95.0|-1.9|6.6|||ANCOVA|Model terms: treatment and baseline HDL-C value|(Atorva + EZ minus Atorva)|||6.6|-1.9|0.273
72534918|NCT00276458|144598680|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-16.4|STANDARD_ERROR_OF_MEAN|2.4|<|0.001||95.0|-21.2|-11.7|||ANCOVA|Model terms: treatment and baseline non-HDL-C value|(Atorva + EZ minus Atorva)|||-11.7|-21.2|<0.001
72534919|NCT00276458|144598681|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-12.2|STANDARD_ERROR_OF_MEAN|1.8|<|0.001||95.0|-15.8|-8.6|||ANCOVA|Model terms: treatment and baseline Total-C value|(Atorva + EZ minus Atorva)|||-8.6|-15.8|<0.001
72572841|NCT00593736|144672849|SUPERIORITY_OR_OTHER|||||||0.428||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.428
72572842|NCT00593736|144672850|SUPERIORITY_OR_OTHER|||||||0.519||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.519
72572843|NCT00593736|144672850|SUPERIORITY_OR_OTHER|||||||0.179||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.179
72572844|NCT00593736|144672850|SUPERIORITY_OR_OTHER|||||||0.935||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.935
72534920|NCT00276458|144598682|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-8.9||||0.159||95.0|-17.7|-0.4||ANCOVA using ranks based on normal scores (Tukey method) with model terms for treatment and baseline triglycerides value|Nonparametric ANCOVA|ANCOVA using ranks based on normal scores (Tukey method) with model terms for treatment and baseline triglycerides value.|"The median difference is based on the Hodges-Lehmann estimates of shift; The distribution-free 95% CI is based on Wilcoxon's rank sum test statistic.~(Atorva + EZ minus Atorva)"|||-0.4|-17.7|0.159
72534921|NCT00276458|144598683|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-13.7|STANDARD_ERROR_OF_MEAN|2.1|<|0.001||95.0|-17.8|-9.6|||ANCOVA|Model terms: treatment and baseline Apo B value|(Atorva + EZ minus Atorva)|||-9.6|-17.8|<0.001
72534922|NCT00276458|144598684|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|1.6||0.681||95.0|-3.9|2.6|||ANCOVA|Model terms: treatment and baseline Apo A-I value|(Atorva + EZ minus Atorva)|||2.6|-3.9|0.681
72534923|NCT00276458|144598685|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-13.1|STANDARD_ERROR_OF_MEAN|2.2|<|0.001||95.0|-17.5|-8.7|||ANCOVA|Model terms: treatment and baseline Total-C:HDL-C value|(Atorva + EZ minus Atorva)|||-8.7|-17.5|<0.001
72534924|NCT00276458|144598686|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-20.9|STANDARD_ERROR_OF_MEAN|2.8|<|0.001||95.0|-26.5|-15.3|||ANCOVA|Model terms: treatment and baseline LDL-C:HDL-C value|(Atorva + EZ minus Atorva)|||-15.3|-26.5|<0.001
72534925|NCT00276458|144598687|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-13.1|STANDARD_ERROR_OF_MEAN|2.4|<|0.001||95.0|-17.9|-8.3|||ANCOVA|Model terms: treatment and baseline Apo B:Apo A-I value|(Atorva + EZ minus Atorva)|||-8.3|-17.9|<0.001
72534926|NCT00276458|144598688|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-17.3|STANDARD_ERROR_OF_MEAN|3.0|<|0.001||95.0|-23.2|-11.4|||ANCOVA|Model terms: treatment and baseline non-HDL-C:HDL-C value|(Atorva + EZ minus Atorva)|||-11.4|-23.2|<0.001
72534927|NCT00276458|144598689|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.5||||0.841||95.0|-23.8|28.8|||Longitudinal Data Analysis (LDA)|LDA method of Liang and Zeger with model terms: treatment, time, and the interaction of time by treatment|"Data for analysis was transformed by the natural log and the difference in geometric mean % change from BL calculated based on the difference in the back-transformed least squares means.~(Atorva + EZ minus Atorva)"|||28.8|-23.8|0.841
72534928|NCT00276458|144598690|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-8.3||||0.839||95.0|-26.1|8.3|||Nonparametric ANCOVA|ANCOVA using ranks based on normal scores (Tukey method) with model terms for treatment and baseline CRP value|"The median difference is based on the Hodges-Lehmann estimates of shift; The distribution-free 95% CI is based on Wilcoxon's rank sum test statistic.~(Atorva + EZ minus Atorva)"|||8.3|-26.1|0.839
72534929|NCT00276458|144598691|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|8.6|||<|0.001||95.0|3.8|19.47|||Regression, Logistic|Model terms: treatment and baseline LDL-C value|Estimated ratio is the predictive odds of attaining LDL-C target on Atorva + EZ versus Atorva.|||19.47|3.80|<0.001
72534930|NCT00750373|144598692|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.1|||<|0.05|TWO_SIDED|95.0|||||Fisher Exact|||We estimated that a sample size of 74 patients would provide 80% power to detect a significant difference with respect to the primary end point at the 2-sided significance level of 0.05, assuming that the in-hospital event rate would be 23% in the conventional treatment group and 3% in the early surgery group.||||<0.05
72534931|NCT00480077|144598704|SUPERIORITY|The primary end point of the study, all-cause death or hospitalization for heart failure, was analyzed on a time-to-first-event basis with the log-rank test. The hazard ratio (HR) associated with allocation to the access arm relative to control was estimated with corresponding 95% confidence interval (CI) by fitting a Cox proportional hazards model containing the treatment group as a categorical factor.||||||0.063|||||||Log Rank|||||||0.063
72572845|NCT00593736|144672851|SUPERIORITY_OR_OTHER|||||||0.425||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.425
72572846|NCT00593736|144672851|SUPERIORITY_OR_OTHER|||||||0.406||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.406
72572847|NCT00593736|144672851|SUPERIORITY_OR_OTHER|||||||0.72||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.720
72572848|NCT00593736|144672852|SUPERIORITY_OR_OTHER|||||||0.294||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.294
72572849|NCT00593736|144672852|SUPERIORITY_OR_OTHER|||||||0.474||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.474
72572850|NCT00593736|144672852|SUPERIORITY_OR_OTHER|||||||0.999||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.999
72572851|NCT00593736|144672853|SUPERIORITY_OR_OTHER|||||||0.655||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.655
72572852|NCT00593736|144672853|SUPERIORITY_OR_OTHER|||||||0.331||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.331
72534932|NCT01683565|144598753|OTHER|Analyses compared the change in Pervasive Developmental Disorders Screening Test-II scores between groups, controlling for baseline scores, using mixed effects regression. This method leverages maximum likelihood to account for missing data. Treatment-by-time interaction terms were included as fixed effects and served as estimates of treatment effect. Group mean differences divided by the standard deviation were also calculated as effect sizes.||||||0.67||||||Threshold for statistical significance (\<0.05)|Mixed Models Analysis|||The sample size was determined based on the goal of confirming trial feasibility and estimating effect sizes for a full-scale trial, not for a definitive test of efficacy. The enrollment goal was 40, which would have provided an indication of an expected effect size for a larger full-scale trial (e.g., 53% power to detect a 2-point decrease (approximately 0.7-SD based on a prior study) in Pervasive Developmental Disorders Screening Test-II score). Funding limitations capped enrollment at 31.||||0.67
72572853|NCT00593736|144672853|SUPERIORITY_OR_OTHER|||||||0.362||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.362
72408229|NCT00378703|144324832|SUPERIORITY_OR_OTHER|||||||0.0076|TWO_SIDED|||||Each combination arm was compared with the bevacizumab alone arm. Since there were 3 pairwise comparisons, a Bonferroni--adjusted p-value of 0.017 was considered to be statistically significant.|Fisher Exact|||The response rate of each combination arm was compared to that of the bevacizumab alone arm.||||0.0076
72572854|NCT00593736|144672854|SUPERIORITY_OR_OTHER|||||||0.684||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.684
72572855|NCT00593736|144672854|SUPERIORITY_OR_OTHER|||||||0.399||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.399
72572856|NCT00593736|144672854|SUPERIORITY_OR_OTHER|||||||0.611||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.611
72572857|NCT00593736|144672855|SUPERIORITY_OR_OTHER|||||||0.157||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.157
72572858|NCT00593736|144672855|SUPERIORITY_OR_OTHER|||||||0.463||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.463
72572859|NCT00593736|144672855|SUPERIORITY_OR_OTHER|||||||0.774||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.774
72572860|NCT00593736|144672856|SUPERIORITY_OR_OTHER|||||||0.413||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.413
72572861|NCT00593736|144672856|SUPERIORITY_OR_OTHER|||||||0.093||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.093
72572862|NCT00593736|144672856|SUPERIORITY_OR_OTHER|||||||0.982||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.982
72572863|NCT00593736|144672857|SUPERIORITY_OR_OTHER|||||||0.441||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.441
72572864|NCT00593736|144672857|SUPERIORITY_OR_OTHER|||||||0.082||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.082
72572865|NCT00593736|144672857|SUPERIORITY_OR_OTHER|||||||0.549||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.549
72572866|NCT00593736|144672858|SUPERIORITY_OR_OTHER|||||||0.86||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.860
72572867|NCT00593736|144672858|SUPERIORITY_OR_OTHER|||||||0.997||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.997
72408230|NCT00378703|144324832|SUPERIORITY_OR_OTHER|||||||0.0085|TWO_SIDED|||||Each combination arm was compared with the bevacizumab alone arm. Since there were 3 pairwise comparisons, a Bonferroni--adjusted p-value of 0.017 was considered to be statistically significant.|Fisher Exact|||The response rate of each combination arm was compared to that of the bevacizumab alone arm.||||0.0085
72408231|NCT00378703|144324832|SUPERIORITY_OR_OTHER|||||||0.3006|TWO_SIDED|||||Each combination arm was compared with the bevacizumab alone arm. Since there were 3 pairwise comparisons, a Bonferroni--adjusted p-value of 0.017 was considered to be statistically significant.|Fisher Exact|||The response rate of each combination arm was compared to that of the bevacizumab alone arm.||||0.3006
72534933|NCT01683565|144598754|OTHER|Analyses compared the change in BITSEA outcome scores between groups, controlling for baseline scores, using mixed effects regression. This method leverages maximum likelihood to account for missing data. Treatment-by-time interaction terms were included as fixed effects and served as estimates of treatment effect; no participant characteristics were included as covariates in the models. Group mean differences divided by the standard deviation were also calculated as effect sizes.||||||0.22||||||Threshold for statistical significance (\<0.05).|Mixed Models Analysis|||The reported p-value is for the comparison of the change in Competence scores between groups (LCPUFA vs. Placebo).||||0.22
72534934|NCT01683565|144598754|OTHER|Analyses compared the change in the BITSEA outcome scores between groups, controlling for baseline scores, using mixed effects regression. This method leverages maximum likelihood to account for missing data. Treatment-by-time interaction terms were included as fixed effects and served as estimates of treatment effect; no participant characteristics were included as covariates in the models. Group mean differences divided by the standard deviation were also calculated as effect sizes||||||0.92||||||Threshold for statistical significance (\<0.05).|Mixed Models Analysis|||The reported p-value is for the comparison of the change in Problem scores between groups (LCPUFA vs. Placebo).||||0.92
72534935|NCT01683565|144598754|OTHER|Analyses compared the change in BITSEA outcome scores between groups, controlling for baseline scores, using mixed effects regression. This method leverages maximum likelihood to account for missing data. Treatment-by-time interaction terms were included as fixed effects and served as estimates of treatment effect; no participant characteristics were included as covariates in the models. Group mean differences divided by the standard deviation were also calculated as effect sizes.||||||0.88|||||||Mixed Models Analysis|||The reported p-value is for the comparison of the change in Dysregulation scores between groups (LCPUFA vs. Placebo).||||0.88
72534936|NCT01683565|144598754|OTHER|Analyses compared the change in BITSEA outcome scores between groups, controlling for baseline scores, using mixed effects regression. This method leverages maximum likelihood to account for missing data. Treatment-by-time interaction terms were included as fixed effects and served as estimates of treatment effect; no participant characteristics were included as covariates in the models. Group mean differences divided by the standard deviation were also calculated as effect sizes.||||||0.23|||||||Mixed Models Analysis|||The reported p-value is for the comparison of the change in Externalizing scores between groups (LCPUFA vs. Placebo).||||0.23
72534937|NCT01683565|144598754|OTHER|Analyses compared the change in BITSEA outcome scores between groups, controlling for baseline scores, using mixed effects regression. This method leverages maximum likelihood to account for missing data. Treatment-by-time interaction terms were included as fixed effects and served as estimates of treatment effect; no participant characteristics were included as covariates in the models. Group mean differences divided by the standard deviation were also calculated as effect sizes.||||||0.91|||||||Mixed Models Analysis|||The reported p-value is for the comparison of the change in Internalizing scores between groups (LCPUFA vs. Placebo).||||0.91
72534938|NCT01683565|144598754|OTHER|Analyses compared the change in BITSEA outcome scores between groups, controlling for baseline scores, using mixed effects regression. This method leverages maximum likelihood to account for missing data. Treatment-by-time interaction terms were included as fixed effects and served as estimates of treatment effect; no participant characteristics were included as covariates in the models. Group mean differences divided by the standard deviation were also calculated as effect sizes.||||||0.03|||||||Mixed Models Analysis|||The reported p-value is for the comparison of the change in Austism Spectrum Disorder scores between groups (LCPUFA vs. Placebo).||||0.03
72534939|NCT01683565|144598754|OTHER|Analyses compared the change in BITSEA outcome scores between groups, controlling for baseline scores, using mixed effects regression. This method leverages maximum likelihood to account for missing data. Treatment-by-time interaction terms were included as fixed effects and served as estimates of treatment effect; no participant characteristics were included as covariates in the models. Group mean differences divided by the standard deviation were also calculated as effect sizes.||||||0.07|||||||Mixed Models Analysis|||The reported p-value is for the comparison of the change in Red Flag scores between groups (LCPUFA vs. Placebo).||||0.07
72534940|NCT01683565|144598755|OTHER|Differences in mean changes in erythrocyte fatty acid composition were examined using t-tests.||||||0.31||||||P-values \<0.05 were considered statistically significant.|t-test, 2 sided|||The reported p-value is for the comparison of the change in erythrocyte fatty acid composition (10:0 nmol/mL) between groups (LCPUFA vs. Placebo).||||0.31
72534941|NCT01683565|144598755|OTHER|Differences in mean changes in erythrocyte fatty acid composition were examined using t-tests.||||||0.47||||||P-values \<0.05 were considered statistically significant.|t-test, 2 sided|||The reported p-value is for the comparison of the change in erythrocyte fatty acid composition (12:0 nmol/mL) between groups (LCPUFA vs. Placebo).||||0.47
72534942|NCT01683565|144598755|OTHER|Differences in mean changes in erythrocyte fatty acid composition were examined using t-tests.||||||0.38||||||P-values \<0.05 were considered statistically significant.|t-test, 2 sided|||The reported p-value is for the comparison of the change in erythrocyte fatty acid composition (14:0 nmol/mL) between groups (LCPUFA vs. Placebo).||||0.38
72534943|NCT01683565|144598755|OTHER|Differences in mean changes in erythrocyte fatty acid composition were examined using t-tests.||||||0.02||||||P-values \<0.05 were considered statistically significant.|t-test, 2 sided|||The reported p-value is for the comparison of the change in erythrocyte fatty acid composition (16:0 nmol/mL) between groups (LCPUFA vs. Placebo).||||0.02
72534944|NCT01683565|144598755|OTHER|Differences in mean changes in erythrocyte fatty acid composition were examined using t-tests.||||||0.16||||||P-values \<0.05 were considered statistically significant.|t-test, 2 sided|||The reported p-value is for the comparison of the change in erythrocyte fatty acid composition (16:1n-7 nmol/mL) between groups (LCPUFA vs. Placebo).||||0.16
72408232|NCT00247728|144324840|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Sample size is based on the paper 'Two-stage selection and testing design for comparative clinical trials', Thall, PF, Simon, R and Ellenberg, SS. Biometrika (1988),75,(2),303-310.||||||0.072||95.0|||||Chi-squared|||||||0.072
72572868|NCT00593736|144672858|SUPERIORITY_OR_OTHER|||||||0.834||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.834
72572869|NCT00593736|144672859|SUPERIORITY_OR_OTHER|||||||0.837||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.837
72572870|NCT00593736|144672859|SUPERIORITY_OR_OTHER|||||||0.321||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.321
72572871|NCT00593736|144672859|SUPERIORITY_OR_OTHER|||||||0.978||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.978
72572872|NCT00593736|144672860|SUPERIORITY_OR_OTHER|||||||0.513||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.513
72572873|NCT00593736|144672860|SUPERIORITY_OR_OTHER|||||||0.751||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.751
72572874|NCT00593736|144672860|SUPERIORITY_OR_OTHER|||||||0.242||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.242
72572875|NCT00593736|144672861|SUPERIORITY_OR_OTHER|||||||0.307||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.307
72626565|NCT01576783|144781968|OTHER|The reported p-value is for the comparison of the change in length-for-age z scores between groups (DHA+AA vs. Placebo).||||||0.27||||||Threshold for statistical significance (\<0.05)|Mixed Models Analysis|Analyses compared the change in scores between groups, using mixed-effects regression that leveraged maximum likelihood to account for missing data.||||||0.27
72408233|NCT00247728|144324840|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Sample size is based on the paper 'Two-stage selection and testing design for comparative clinical trials', Thall, PF, Simon, R and Ellenberg, SS. Biometrika (1988),75,(2),303-310.||||||0.298||95.0|||||Chi-squared|||||||0.298
72626566|NCT01576783|144781968|OTHER|The reported p-value is for the comparison of the change in head circumference-for-age z scores between groups (DHA+AA vs. Placebo).||||||0.39||||||Threshold for statistical significance (\<0.05)|Mixed Models Analysis|Analyses compared the change in scores between groups, using mixed-effects regression that leveraged maximum likelihood to account for missing data.||||||0.39
72626567|NCT01576783|144781968|OTHER|The reported p-value is for the comparison of the change in mid upper arm circumference-for-age z scores between groups (DHA+AA vs. Placebo).||||||0.25||||||Threshold for statistical significance (\<0.05)|Mixed Models Analysis|Analyses compared the change in scores between groups, using mixed-effects regression that leveraged maximum likelihood to account for missing data.||||||0.25
72408234|NCT00247728|144324841|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.59||||0.087||95.0|||||Mantel Haenszel|||||||0.087
72408235|NCT00247728|144324841|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.87||||0.653||95.0|||||Mantel Haenszel|||||||0.653
72572876|NCT00593736|144672861|SUPERIORITY_OR_OTHER|||||||0.765||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.765
72572877|NCT00593736|144672861|SUPERIORITY_OR_OTHER|||||||0.727||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.727
72572878|NCT00593736|144672862|SUPERIORITY_OR_OTHER|||||||0.902||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.902
72572879|NCT00593736|144672862|SUPERIORITY_OR_OTHER|||||||0.59||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.590
72572880|NCT00593736|144672862|SUPERIORITY_OR_OTHER|||||||0.29||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.290
72408236|NCT01868633|144324846|SUPERIORITY_OR_OTHER|||||||0.32|||||||Wilcoxon (Mann-Whitney)|||||||0.32
72408237|NCT02457325|144324851|SUPERIORITY_OR_OTHER_LEGACY|||||||0.192|||||||t-test, 2 sided|||||||0.192
72408238|NCT02457325|144324852|SUPERIORITY_OR_OTHER_LEGACY|||||||0.457|||||||t-test, 2 sided|||||||0.457
72408239|NCT02457325|144324853|SUPERIORITY_OR_OTHER_LEGACY|||||||0.158|||||||t-test, 2 sided|||||||0.158
72408240|NCT02457325|144324854|SUPERIORITY_OR_OTHER_LEGACY|||||||0.953|||||||t-test, 2 sided|||||||0.953
72408241|NCT02457325|144324855|SUPERIORITY_OR_OTHER_LEGACY|||||||0.693|||||||t-test, 2 sided|||||||0.693
72408242|NCT02457325|144324856|SUPERIORITY_OR_OTHER_LEGACY|||||||0.158|||||||t-test, 2 sided|||||||0.158
72408243|NCT02457325|144324857|SUPERIORITY_OR_OTHER_LEGACY|||||||0.192|||||||t-test, 2 sided|||||||0.192
72408244|NCT02457325|144324858|SUPERIORITY_OR_OTHER_LEGACY|||||||0.512|||||||t-test, 2 sided|||||||0.512
72534945|NCT01683565|144598755|OTHER|Differences in mean changes in erythrocyte fatty acid composition were examined using t-tests.||||||0.02||||||P-values \<0.05 were considered statistically significant.|t-test, 2 sided|||The reported p-value is for the comparison of the change in erythrocyte fatty acid composition (18:0 nmol/mL) between groups (LCPUFA vs. Placebo).||||0.02
72534946|NCT01683565|144598755|OTHER|Differences in mean changes in erythrocyte fatty acid composition were examined using t-tests.||||||0.02||||||P-values \<0.05 were considered statistically significant.|t-test, 2 sided|||The reported p-value is for the comparison of the change in erythrocyte fatty acid composition (18:1n-9 nmol/mL) between groups (LCPUFA vs. Placebo).||||0.02
72534947|NCT01683565|144598755|OTHER|Differences in mean changes in erythrocyte fatty acid composition were examined using t-tests.||||||0.21||||||P-values \<0.05 were considered statistically significant.|t-test, 2 sided|||The reported p-value is for the comparison of the change in erythrocyte fatty acid composition (18:2n-6 nmol/mL) between groups (LCPUFA vs. Placebo).||||0.21
72534948|NCT01683565|144598755|OTHER|Differences in mean changes in erythrocyte fatty acid composition were examined using t-tests.||||||0.34||||||P-values \<0.05 were considered statistically significant.|t-test, 2 sided|||The reported p-value is for the comparison of the change in erythrocyte fatty acid composition (18:3n-6 nmol/mL) between groups (LCPUFA vs. Placebo).||||0.34
72534949|NCT01683565|144598755|OTHER|Differences in mean changes in erythrocyte fatty acid composition were examined using t-tests.||||||0.24||||||P-values \<0.05 were considered statistically significant.|t-test, 2 sided|||The reported p-value is for the comparison of the change in erythrocyte fatty acid composition (18:3n-3 nmol/mL) between groups (LCPUFA vs. Placebo).||||0.24
72534950|NCT01683565|144598755|OTHER|Differences in mean changes in erythrocyte fatty acid composition were examined using t-tests.||||||0.5||||||P-values \<0.05 were considered statistically significant.|t-test, 2 sided|||The reported p-value is for the comparison of the change in erythrocyte fatty acid composition (18:4n-3 nmol/mL ) between groups (LCPUFA vs. Placebo).||||0.50
72534951|NCT01683565|144598755|OTHER|Differences in mean changes in erythrocyte fatty acid composition were examined using t-tests.||||||0.07||||||P-values \<0.05 were considered statistically significant.|t-test, 2 sided|||The reported p-value is for the comparison of the change in erythrocyte fatty acid composition (20:3n-6 nmol/mL) between groups (LCPUFA vs. Placebo).||||0.07
72534952|NCT01683565|144598755|OTHER|Differences in mean changes in erythrocyte fatty acid composition were examined using t-tests.||||||0.1||||||P-values \<0.05 were considered statistically significant.|t-test, 2 sided|||The reported p-value is for the comparison of the change in erythrocyte fatty acid composition (20:4n-6 nmol/mL) between groups (LCPUFA vs. Placebo).||||0.10
72534953|NCT01683565|144598755|OTHER|Differences in mean changes in erythrocyte fatty acid composition were examined using t-tests.||||||0.001||||||P-values \<0.05 were considered statistically significant.|t-test, 2 sided|||The reported p-value is for the comparison of the change in erythrocyte fatty acid composition (20:5n-3 nmol/mL) between groups (LCPUFA vs. Placebo).||||0.001
72626568|NCT01576783|144781968|OTHER|The reported p-value is for the comparison of the change in triceps skinfold-for-age z scores between groups (DHA+AA vs. Placebo).||||||0.85||||||Threshold for statistical significance (\<0.05)|Mixed Models Analysis|Analyses compared the change in scores between groups, using mixed-effects regression that leveraged maximum likelihood to account for missing data.||||||0.85
72626569|NCT01576783|144781968|OTHER|The reported p-value is for the comparison of the change in subscapular skinfold-for-age z scores between groups (DHA+AA vs. Placebo).||||||0.82||||||Threshold for statistical significance (\<0.05)|Mixed Models Analysis|Analyses compared the change in scores between groups, using mixed-effects regression that leveraged maximum likelihood to account for missing data.||||||0.82
72626570|NCT01576783|144781969|OTHER|The reported p-value is for the comparison of the scores between groups (DHA+AA vs. Placebo) at the end of the trial.||||||0.42||||||Threshold for statistical significance (\<0.05).|Mixed Models Analysis|Continuous scores at the end of the trial were compared using a linear mixed model.||||||0.42
72534954|NCT01683565|144598755|OTHER|Differences in mean changes in erythrocyte fatty acid composition were examined using t-tests.||||||0.71||||||P-values \<0.05 were considered statistically significant.|t-test, 2 sided|||The reported p-value is for the comparison of the change in erythrocyte fatty acid composition (22:5n-3 nmol/mL) between groups (LCPUFA vs. Placebo).||||0.71
72534955|NCT01683565|144598755|OTHER|Differences in mean changes in erythrocyte fatty acid composition were examined using t-tests.||||||0.001||||||P-values \<0.05 were considered statistically significant.|t-test, 2 sided|||The reported p-value is for the comparison of the change in erythrocyte fatty acid composition (22:6n-3 nmol/mL) between groups (LCPUFA vs. Placebo).||||0.001
72534956|NCT01683565|144598755|OTHER|Differences in mean changes in erythrocyte fatty acid composition were examined using t-tests.||||||0.1||||||P-values \<0.05 were considered statistically significant.|t-test, 2 sided|||The reported p-value is for the comparison of the change in erythrocyte fatty acid composition (Total Omega-6) between groups (LCPUFA vs. Placebo).||||0.10
72534957|NCT01683565|144598755|OTHER|Differences in mean changes in erythrocyte fatty acid composition were examined using t-tests.||||||0.1||||||P-values \<0.05 were considered statistically significant.|t-test, 2 sided|||The reported p-value is for the comparison of the change in erythrocyte fatty acid composition (total omega-3) between groups (LCPUFA vs. Placebo).||||0.10
72534958|NCT05261126|144598766|SUPERIORITY|One-sided p-value and difference in least squares means based on a cLDA model including terms for treatment, time, baseline statin intensity, baseline renal function, and the interaction of treatment by time.|Difference in Least Squares Means|-41.2|||<|0.001|TWO_SIDED|95.0|-47.8|-34.7|||cLDA||MK-0616 6 mg minus Placebo|||-34.7|-47.8|<0.001
72534959|NCT05261126|144598766|SUPERIORITY|One-sided p-value and difference in least squares means based on a cLDA model including terms for treatment, time, baseline statin intensity, baseline renal function, and the interaction of treatment by time.|Difference in Least Squares Means|-55.7|||<|0.001|TWO_SIDED|95.0|-62.3|-49.1|||cLDA||MK-0616 12 mg minus Placebo|||-49.1|-62.3|<0.001
72534960|NCT05261126|144598766|SUPERIORITY|One-sided p-value and difference in least squares means based on a cLDA model including terms for treatment, time, baseline statin intensity, baseline renal function, and the interaction of treatment by time.|Difference in Least Squares Means|-59.1|||<|0.001|TWO_SIDED|95.0|-65.7|-52.5|||cLDA||MK-0616 18 mg minus Placebo|||-52.5|-65.7|<0.001
72408245|NCT02457325|144324859|SUPERIORITY_OR_OTHER_LEGACY|||||||0.115|||||||t-test, 2 sided|||||||0.115
72408246|NCT02457325|144324860|SUPERIORITY_OR_OTHER_LEGACY|||||||0.73|||||||t-test, 2 sided|||||||0.730
72408247|NCT02457325|144324861|SUPERIORITY_OR_OTHER_LEGACY|||||||0.835|||||||t-test, 2 sided|||||||0.835
72408248|NCT02915744|144324878|OTHER||ESMO-MCBS (v1.0)|1.0|||||TWO_SIDED|||||||||||||
72408249|NCT00813358|144324880|NON_INFERIORITY|NI=7%|KM product-limit estimator|99.1|||||TWO_SIDED|95.0|97.4|100.0||||||||100|97.4|
72408250|NCT00991302|144324903|SUPERIORITY_OR_OTHER|||||||0.52|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|stratified by dosing complexity||"Treatment comparison was made using a Wilcoxon rank sum test stratified by dosing complexity.~The test was not stratified by region of enrollment due to dosing complexity and region of enrollment were almost identical: almost all (exception with two) participants in the US region were on QD and all participants in the Peru region were on BID or TID."||||0.52
72534961|NCT05261126|144598766|SUPERIORITY|One-sided p-value and difference in least squares means based on a cLDA model including terms for treatment, time, baseline statin intensity, baseline renal function, and the interaction of treatment by time.|Difference in Least Squares Means|-60.9|||<|0.001|TWO_SIDED|95.0|-67.6|-54.3|||cLDA||MK-0616 30 mg minus Placebo|||-54.3|-67.6|<0.001
72534962|NCT05261126|144598767|OTHER|Difference in percentage based on Miettinen \& Nurminen method.|Difference in Percentage|0.2|||||TWO_SIDED|95.0|-15.5|15.8|||||MK-0616 6 mg minus Placebo|||15.8|-15.5|
72534963|NCT05261126|144598767|OTHER|Difference in percentage based on Miettinen \& Nurminen method.|Difference in Percentage|-4.5|||||TWO_SIDED|95.0|-20.0|11.2|||||MK-0616 12 mg vs Placebo|||11.2|-20.0|
72534964|NCT05261126|144598767|OTHER|Difference in percentage based on Miettinen \& Nurminen method.|Difference in Percentage|-0.6|||||TWO_SIDED|95.0|-16.3|15.1|||||MK-0616 18 mg vs Placebo|||15.1|-16.3|
72534965|NCT05261126|144598767|OTHER|Difference in percentage based on Miettinen \& Nurminen method.|Difference in Percentage|-1.9|||||TWO_SIDED|95.0|-17.5|13.8|||||MK-0616 30 mg minus Placebo|||13.8|-17.5|
72534966|NCT05261126|144598769|SUPERIORITY|One-sided p-value and difference in least squares means based on a cLDA model including terms for treatment, time, baseline statin intensity, baseline renal function, and the interaction of treatment by time.|Difference in Least Squares Means|-32.8|||<|0.001|TWO_SIDED|95.0|-38.6|-26.9|||cLDA||MK-0616 6 mg minus Placebo|||-26.9|-38.6|<0.001
72534967|NCT05261126|144598769|SUPERIORITY|One-sided p-value and difference in least squares means based on a cLDA model including terms for treatment, time, baseline statin intensity, baseline renal function, and the interaction of treatment by time.|Difference in Least Squares Means|-45.8|||<|0.001|TWO_SIDED|95.0|-51.7|-39.9|||cLDA||MK-0616 12 mg minus Placebo|||-39.9|-51.7|<0.001
72534968|NCT05261126|144598769|SUPERIORITY|One-sided p-value and difference in least squares means based on a cLDA model including terms for treatment, time, baseline statin intensity, baseline renal function, and the interaction of treatment by time.|Difference in Least Squares Means|-48.7|||<|0.001|TWO_SIDED|95.0|-54.6|-42.8|||cLDA||MK-0616 18 mg minus Placebo|||-42.8|-54.6|<0.001
72534969|NCT05261126|144598769|SUPERIORITY|One-sided p-value and difference in least squares means based on a cLDA model including terms for treatment, time, baseline statin intensity, baseline renal function, and the interaction of treatment by time.|Difference in Least Square Means|-51.8|||<|0.001|TWO_SIDED|95.0|-57.7|-45.9|||cLDA||MK-0616 30 mg minus Placebo|||-45.9|-57.7|<0.001
72534970|NCT05261126|144598770|SUPERIORITY|One-sided p-value and difference in least squares means based on a cLDA model including terms for treatment, time, baseline statin intensity, baseline renal function, and the interaction of treatment by time.|Difference in Least Squares Means|-35.9|||<|0.001|TWO_SIDED|95.0|-42.4|-29.4|||cLDA||MK-0616 6 mg minus Placebo|||-29.4|-42.4|<0.001
72534971|NCT05261126|144598770|SUPERIORITY|One-sided p-value and difference in least squares means based on a cLDA model including terms for treatment, time, baseline statin intensity, baseline renal function, and the interaction of treatment by time.|Difference in Least Squares Means|-50.5|||<|0.001|TWO_SIDED|95.0|-57.0|-44.0|||cLDA||MK-0616 12 mg minus Placebo|||-44.0|-57.0|<0.001
72534972|NCT05261126|144598770|SUPERIORITY|One-sided p-value and difference in least squares means based on a cLDA model including terms for treatment, time, baseline statin intensity, baseline renal function, and the interaction of treatment by time.|Difference in Least Squares Means|-53.2|||<|0.001|TWO_SIDED|95.0|-59.7|-46.7|||cLDA||MK-0616 18 mg minus Placebo|||-46.7|-59.7|<0.001
72534973|NCT05261126|144598770|SUPERIORITY|One-sided p-value and difference in least squares means based on a cLDA model including terms for treatment, time, baseline statin intensity, baseline renal function, and the interaction of treatment by time.|Difference in Least Squares Means|-55.8|||<|0.001|TWO_SIDED|95.0|-62.3|-49.3|||cLDA||MK-0616 30 mg minus Placebo|||-49.3|-62.3|<0.001
72534974|NCT05261126|144598771|SUPERIORITY|One-sided p-value and difference in percentage based on Miettinen \& Nurminen method, with sample size weighting, stratified by background statin intensity.|Difference in Percentage|69.2|||<|0.001|TWO_SIDED|95.0|56.2|79.0|||Miettinen & Nurminen||MK-0616 6 mg minus Placebo|||79.0|56.2|<0.001
72534975|NCT05261126|144598771|SUPERIORITY|One-sided p-value and difference in percentage based on Miettinen \& Nurminen method, with sample size weighting, stratified by background statin intensity.|Difference in Percentage|75.2|||<|0.001|TWO_SIDED|95.0|62.9|84.0|||Miettinen & Nurminen method||MK-0616 12 mg minus Placebo|||84.0|62.9|<0.001
72534976|NCT05261126|144598771|SUPERIORITY|One-sided p-value and difference in percentage based on Miettinen \& Nurminen method, with sample size weighting, stratified by background statin intensity.|Difference in Percentage|79.2|||<|0.001|TWO_SIDED|95.0|67.1|87.1|||Miettinen & Nurminen method||MK-0616 18 mg minus Placebo|||87.1|67.1|<0.001
72534977|NCT05261126|144598771|SUPERIORITY|One-sided p-value and difference in percentage based on Miettinen \& Nurminen method, with sample size weighting, stratified by background statin intensity.|Difference in Percentage|79.5|||<|0.001|TWO_SIDED|95.0|67.9|87.4|||Miettinen & Nurminen method||MK-0616 30 mg minus Placebo|||87.4|67.9|<0.001
72534978|NCT03901274|144598772|SUPERIORITY||Slope|-0.16|STANDARD_ERROR_OF_MEAN|0.29|||TWO_SIDED|95.0|-0.74|0.42|||||Parameter estimated with full information maximum likelihood|Intent-to-treat on three month outcomes with intake (i.e. Pretest covariate)||0.42|-0.74|
72534979|NCT03901274|144598772|SUPERIORITY||Slope|-0.65|STANDARD_ERROR_OF_MEAN|0.28|||TWO_SIDED|95.0|-1.2|-0.09|||||Parameter estimated with full information maximum likelihood|Intent-to-treat on six month outcomes with intake (i.e. Pretest covariate)||-0.09|-1.20|
72534980|NCT00145119|144598808|SUPERIORITY_OR_OTHER_LEGACY||proportion (%)|8.0||||||||||||||||||
72408251|NCT01709318|144324911|NON_INFERIORITY|Based on a longitudinal data analysis (LDA) model with terms for treatment, cycle and the interaction cycle by treatment and stratum:starter/switcher followed by Miettinen and Nurminen's method. Non-inferiority criterion was met if the upper bound of the 95% CI of the difference is less than or equal to 10%.|Difference in Percent|8.3|||||TWO_SIDED|95.0|-4.3|26.5|||||95% CI adjusted for multiplicity (Dunnett)|||26.5|-4.3|
72408252|NCT01709318|144324911|NON_INFERIORITY|Based on a LDA model with terms for treatment, cycle and the interaction cycle by treatment and stratum:starter/switcher followed by Miettinen and Nurminen's method. Non-inferiority criterion was met if the upper bound of the 95% CI of the difference is less than or equal to 10%.|Difference in Percent|6.5|||||TWO_SIDED|95.0|-5.7|24.8|||||95% CI adjusted for multiplicity (Dunnett)|||24.8|-5.7|
72408253|NCT01709318|144324911|NON_INFERIORITY|Based on a LDA model with terms for treatment, cycle and the interaction cycle by treatment and stratum:starter/switcher followed by Miettinen and Nurminen's method. Non-inferiority criterion was met if the upper bound of the 95% CI of the difference is less than or equal to 10%.|Difference in Percent|12.3|||||TWO_SIDED|95.0|-1.7|33.1|||||95% CI adjusted for multiplicity (Dunnett)|||33.1|-1.7|
72408254|NCT01709318|144324911|NON_INFERIORITY|Based on a LDA model with terms for treatment, cycle and the interaction cycle by treatment and stratum:starter/switcher followed by Miettinen and Nurminen's method. Non-inferiority criterion was met if the upper bound of the 95% CI of the difference is less than or equal to 10%.|Difference in Percent|6.6|||||TWO_SIDED|95.0|-5.7|25.4|||||95% CI adjusted for multiplicity (Dunnett)|||25.4|-5.7|
72408255|NCT01709318|144324911|NON_INFERIORITY|Based on a LDA model with terms for treatment, cycle and the interaction cycle by treatment and stratum:starter/switcher followed by Miettinen and Nurminen's method. Non-inferiority criterion was met if the upper bound of the 95% CI of the difference is less than or equal to 10%.|Difference in Percent|9.3|||||TWO_SIDED|95.0|-3.5|27.4|||||95% CI adjusted for multiplicity (Dunnett)|||27.4|-3.5|
72408256|NCT01709318|144324911|NON_INFERIORITY|Based on a LDA model with terms for treatment, cycle and the interaction cycle by treatment and stratum:starter/switcher followed by Miettinen and Nurminen's method. Non-inferiority criterion was met if the upper bound of the 95% CI of the difference is less than or equal to 10%.|Difference in Percent|0.0|||||TWO_SIDED|95.0|-10.7|15.9|||||95% CI adjusted for multiplicity (Dunnett)|||15.9|-10.7|
72408257|NCT01709318|144324912|NON_INFERIORITY|Based on a LDA model with terms for treatment, cycle and the interaction cycle by treatment and stratum:starter/switcher followed by Miettinen and Nurminen's method. Non-inferiority criterion was met if the upper bound of the 95% CI of the difference is less than or equal to 10%.|Difference in Percent|3.2|||||TWO_SIDED|95.0|-3.6|16.4|||||95% CI adjusted for multiplicity (Dunnett)|||16.4|-3.6|
72534981|NCT03671746|144598825|SUPERIORITY||Median Difference (Final Values)|1.5|STANDARD_DEVIATION|1.5|=|0.275|TWO_SIDED||||||ANOVA|A Kenward-Roger adjustment was used to correct for negative bias in the standard errors and degrees of freedom calculations.||Sample size calculations were performed using Length of Stay (LOS) as this was the primary outcome. Using a significance level of 0.05 and assumed standard deviation of 1.5 days, a sample size of 42 patients/group (84 total) would yield 80% power to detect a difference of 0.928 days in average LOS between groups. Allowing for a dropout rate of up to 25%, recruitment was planned for 56 patients/group. Power calculations were performed using nQuery 8.5 (Statistical Solutions Ltd; Cork, Ireland).||||=0.275
72408258|NCT01709318|144324912|NON_INFERIORITY|Based on a LDA model with terms for treatment, cycle and the interaction cycle by treatment and stratum:starter/switcher followed by Miettinen and Nurminen's method. Non-inferiority criterion was met if the upper bound of the 95% CI of the difference is less than or equal to 10%.|Difference in Percent|0.0|||||TWO_SIDED|95.0|-6.2|11.0|||||95% CI adjusted for multiplicity (Dunnett)|||11.0|-6.2|
72534982|NCT03671746|144598826|SUPERIORITY||||||<|0.05|||||||Mixed Models Analysis|A Kenward-Roger adjustment was used to correct for negative bias in the standard errors and degrees of freedom calculations.||Sample size calculations were performed using LOS as this was the primary outcome. Using a significance level of 0.05 and an assumed standard deviation of 1.5 days, a sample size of 42 patients/group (84 total) would yield 80% power to detect a difference of 0.928 days in average LOS between groups. Allowing for a dropout rate of up to 25%, recruitment was originally planned for 56 patients/group. Power calculations were performed using nQuery 8.5 (Statistical Solutions Ltd; Cork, Ireland).||||<0.05
72408259|NCT01709318|144324912|NON_INFERIORITY|Based on a LDA model with terms for treatment, cycle and the interaction cycle by treatment and stratum:starter/switcher followed by Miettinen and Nurminen's method. Non-inferiority criterion was met if the upper bound of the 95% CI of the difference is less than or equal to 10%.|Difference in Percent|3.0|||||TWO_SIDED|95.0|-3.8|17.5|||||95% CI adjusted for multiplicity (Dunnett)|||17.5|-3.8|
72408260|NCT01709318|144324912|NON_INFERIORITY|Based on a LDA model with terms for treatment, cycle and the interaction cycle by treatment and stratum:starter/switcher followed by Miettinen and Nurminen's method. Non-inferiority criterion was met if the upper bound of the 95% CI of the difference is less than or equal to 10%.|Difference in Percent|4.7|||||TWO_SIDED|95.0|-2.5|18.9|||||95% CI adjusted for multiplicity (Dunnett)|||18.9|-2.5|
72534983|NCT03671746|144598827|SUPERIORITY||||||<|0.05|||||||Mixed Models Analysis|The VAS model was adjusted for baseline levels as a covariate, which differed significantly between groups.||Sample size calculations were performed regarding LOS as this was the primary outcome measure. Using a significance level of 0.05 and an assumed SD of 1.5 days, a sample size of 42 patients per group (84 total) would yield 80% power to detect a difference of 0.928 days in average LOS between groups. Allowing for a dropout rate of up to 25%, recruitment was originally planned for 56 patients per group. Power calculations were performed using nQuery 8.5 (Statistical Solutions Ltd; Cork, Ireland).||||<0.05
72542651|NCT01864525|144615271|SUPERIORITY|||||||0.0499||||||Statistical results for Magnitude of acoustic amplitude tremor. A priori significance threshold was set at P\<0.05 for each of the two hypothesis-driven acoustic variables.|Mixed Models Analysis|This statistical test used the baseline scores as a covariate when comparing post-test scores between placebo and octanoic acid conditions.||Separate measures for magnitude of amplitude tremor and magnitude of frequency tremor were analyzed as these variables can respond differently to treatment and may be differentially affected in essential voice tremor. Statistical modeling tested for post-treatment drug differences, with testing session as a repeated factor. Models were run with and without inclusion of baseline averages as a covariate per recommendations for cross-over treatment studies (Fleiss, Wallenstein \& Rosenfeld, 1985).||||0.0499
72572881|NCT00593736|144672863|SUPERIORITY_OR_OTHER|||||||0.685||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.685
72572882|NCT00593736|144672863|SUPERIORITY_OR_OTHER|||||||0.214||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.214
72572883|NCT00593736|144672863|SUPERIORITY_OR_OTHER|||||||0.055||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.055
72572884|NCT00593736|144672864|SUPERIORITY_OR_OTHER|||||||0.589||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.589
72408261|NCT01709318|144324912|NON_INFERIORITY|Based on a LDA model with terms for treatment, cycle and the interaction cycle by treatment and stratum:starter/switcher followed by Miettinen and Nurminen's method. Non-inferiority criterion was met if the upper bound of the 95% CI of the difference is less than or equal to 10%.|Difference in Percent|1.4|||||TWO_SIDED|95.0|-5.0|13.4|||||95% CI adjusted for multiplicity (Dunnett)|||13.4|-5.0|
72534984|NCT03671746|144598828|SUPERIORITY||||||=|0.564|||||||Mixed Models Analysis|A Kenward-Roger adjustment was used to correct for negative bias in the standard errors and degrees of freedom calculations.||Sample size calculations were performed regarding LOS as this was the primary outcome measure. Using a significance level of 0.05 and an assumed SD of 1.5 days, a sample size of 42 patients per group (84 total) would yield 80% power to detect a difference of 0.928 days in average LOS between groups. Allowing for a dropout rate of up to 25%, recruitment was originally planned for 56 patients per group. Power calculations were performed using nQuery 8.5 (Statistical Solutions Ltd; Cork, Ireland).|Group-level summary statistics were calculated for demographic and clinical variables, and differences between groups were evaluated using two-sample t-tests for quantitative measures and Fisher's exact tests for categorical measures, as appropriate. Time and group comparisons for each cytokine were made using linear mixed models, with and without adjusting for selected covariates. Patient demographic variables and clinical outcomes of interest were considered for inclusion as covariates in each model but were only retained if they significantly improved the model. Linear mixed models were log-transformed, double-log-transformed, or square-root-transformed to correct for right skewness, as appropriate. Likelihood ratio testing and Akaike information criterion were used to select appropriate covariance structures in each case. All analyses were completed in SAS 9.4 (SAS Institute Inc.; Cary, NC, USA).|||=0.564
72534985|NCT03671746|144598829|SUPERIORITY||||||=|0.118|||||||Mixed Models Analysis|A Kenward-Roger adjustment was used to correct for negative bias in the standard errors and degrees of freedom calculations.||Sample size calculations were performed regarding LOS as this was the primary outcome measure. Using a significance level of 0.05 and an assumed SD of 1.5 days, a sample size of 42 patients per group (84 total) would yield 80% power to detect a difference of 0.928 days in average LOS between groups. Allowing for a dropout rate of up to 25%, recruitment was originally planned for 56 patients per group. Power calculations were performed using nQuery 8.5 (Statistical Solutions Ltd; Cork, Ireland).|Group-level summary statistics were calculated for demographic and clinical variables, and differences between groups were evaluated using two-sample t-tests for quantitative measures and Fisher's exact tests for categorical measures, as appropriate. Time and group comparisons for each cytokine were made using linear mixed models, with and without adjusting for selected covariates. Patient demographic variables and clinical outcomes of interest were considered for inclusion as covariates in each model but were only retained if they significantly improved the model. Linear mixed models were log-transformed, double-log-transformed, or square-root-transformed to correct for right skewness, as appropriate. Likelihood ratio testing and Akaike information criterion were used to select appropriate covariance structures in each case. All analyses were completed in SAS 9.4 (SAS Institute Inc.; Cary, NC, USA).|||=0.118
72572885|NCT00593736|144672864|SUPERIORITY_OR_OTHER|||||||0.156||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.156
72572886|NCT00593736|144672864|SUPERIORITY_OR_OTHER|||||||0.041||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.041
72572887|NCT03493386|144672866|EQUIVALENCE|If the 90% CI of the ratio of geometric mean doesn't fall within a range of 0.80 to 1.25 i.e., null hypothesis is not rejected the bioequivalence is established if the point estimate falls within a range of 0.90 to 1.11|Ratio of geometric mean|1.02|||||TWO_SIDED|90.0|0.97|1.07|||||AUC (0-t)|||1.07|0.97|
72572888|NCT03493386|144672866|EQUIVALENCE|If the 90% CI of the ratio of geometric mean doesn't fall within a range of 0.80 to 1.25 i.e., null hypothesis is not rejected the bioequivalence is established if the point estimate falls within a range of 0.90 to 1.11|Ratio of geometric mean|1.02|||||TWO_SIDED|90.0|0.97|1.07|||||AUC(0-inf)|||1.07|0.97|
72572889|NCT03493386|144672867|EQUIVALENCE|If the 90% CI of the ratio of geometric mean doesn't fall within a range of 0.80 to 1.25 i.e., null hypothesis is not rejected the bioequivalence is established if the point estimate falls within a range of 0.90 to 1.11|Ratio of geometric mean|1.04|||||TWO_SIDED|90.0|0.97|1.12|||||Cmax|||1.12|0.97|
72572890|NCT03493386|144672874|EQUIVALENCE|If the 90% CI of the ratio of geometric mean doesn't fall within a range of 0.80 to 1.25 i.e., null hypothesis is not rejected the bioequivalence is established if the point estimate falls within a range of 0.90 to 1.11|Ratio of geometric mean|0.91|||||TWO_SIDED|90.0|0.82|1.01|||||AUC (0-t)|||1.01|0.82|
72408262|NCT01709318|144324912|NON_INFERIORITY|Based on a LDA model with terms for treatment, cycle and the interaction cycle by treatment and stratum:starter/switcher followed by Miettinen and Nurminen's method. Non-inferiority criterion was met if the upper bound of the 95% CI of the difference is less than or equal to 10%.|Difference in Percent|0.0|||||TWO_SIDED|95.0|-6.2|11.0|||||95% CI adjusted for multiplicity (Dunnett)|||11.0|-6.2|
72408263|NCT01709318|144324913|OTHER|Based on longitudinal data analysis (LDA) model: generalized linear mixed model with terms for stratum, ring group, cycle (and the interaction of cycle by ring group), and continuous response variable.|Difference of Least Squares (LS) Mean|-0.08||||0.096|||||||LDA|||||||0.096
72408264|NCT01709318|144324913|OTHER|Based on longitudinal data analysis model: generalized linear mixed model with terms for stratum, ring group, cycle (and the interaction of cycle by ring group), and continuous response variable.|Difference of LS Mean|-0.03||||0.993|||||||LDA|||||||0.993
72534986|NCT03671746|144598830|SUPERIORITY|||||||0.215|||||||Mixed Models Analysis|A Kenward-Roger adjustment was used to correct for negative bias in the standard errors and degrees of freedom calculations.||Sample size calculations were performed regarding LOS as this was the primary outcome measure. Using a significance level of 0.05 and an assumed SD of 1.5 days, a sample size of 42 patients per group (84 total) would yield 80% power to detect a difference of 0.928 days in average LOS between groups. Allowing for a dropout rate of up to 25%, recruitment was originally planned for 56 patients per group. Power calculations were performed using nQuery 8.5 (Statistical Solutions Ltd; Cork, Ireland).|Group-level summary statistics were calculated for demographic and clinical variables, and differences between groups were evaluated using two-sample t-tests for quantitative measures and Fisher's exact tests for categorical measures, as appropriate. Time and group comparisons for each cytokine were made using linear mixed models, with and without adjusting for selected covariates. Patient demographic variables and clinical outcomes of interest were considered for inclusion as covariates in each model but were only retained if they significantly improved the model. Linear mixed models were log-transformed, double-log-transformed, or square-root-transformed to correct for right skewness, as appropriate. Likelihood ratio testing and Akaike information criterion were used to select appropriate covariance structures in each case. All analyses were completed in SAS 9.4 (SAS Institute Inc.; Cary, NC, USA).|||0.215
72534987|NCT03671746|144598831|SUPERIORITY||||||=|0.043|||||||Mixed Models Analysis|A Kenward-Roger adjustment was used to correct for negative bias in the standard errors and degrees of freedom calculations||Sample size calculations were performed regarding LOS as this was the primary outcome measure. Using a significance level of 0.05 and an assumed SD of 1.5 days, a sample size of 42 patients per group (84 total) would yield 80% power to detect a difference of 0.928 days in average LOS between groups. Allowing for a dropout rate of up to 25%, recruitment was originally planned for 56 patients per group. Power calculations were performed using nQuery 8.5 (Statistical Solutions Ltd; Cork, Ireland).|Group-level summary statistics were calculated for demographic and clinical variables, and differences between groups were evaluated using two-sample t-tests for quantitative measures and Fisher's exact tests for categorical measures, as appropriate. Time and group comparisons for each cytokine were made using linear mixed models, with and without adjusting for selected covariates. Patient demographic variables and clinical outcomes of interest were considered for inclusion as covariates in each model but were only retained if they significantly improved the model. Linear mixed models were log-transformed, double-log-transformed, or square-root-transformed to correct for right skewness, as appropriate. Likelihood ratio testing and Akaike information criterion were used to select appropriate covariance structures in each case. All analyses were completed in SAS 9.4 (SAS Institute Inc.; Cary, NC, USA).|||=0.043
72534988|NCT03671746|144598832|SUPERIORITY||||||=|0.617|||||||Mixed Models Analysis|A Kenward-Roger adjustment was used to correct for negative bias in the standard errors and degrees of freedom calculations.||Sample size calculations were performed regarding LOS as this was the primary outcome measure. Using a significance level of 0.05 and an assumed SD of 1.5 days, a sample size of 42 patients per group (84 total) would yield 80% power to detect a difference of 0.928 days in average LOS between groups. Allowing for a dropout rate of up to 25%, recruitment was originally planned for 56 patients per group. Power calculations were performed using nQuery 8.5 (Statistical Solutions Ltd; Cork, Ireland).|Group-level summary statistics were calculated for demographic and clinical variables, and differences between groups were evaluated using two-sample t-tests for quantitative measures and Fisher's exact tests for categorical measures, as appropriate. Time and group comparisons for each cytokine were made using linear mixed models, with and without adjusting for selected covariates. Patient demographic variables and clinical outcomes of interest were considered for inclusion as covariates in each model but were only retained if they significantly improved the model. Linear mixed models were log-transformed, double-log-transformed, or square-root-transformed to correct for right skewness, as appropriate. Likelihood ratio testing and Akaike information criterion were used to select appropriate covariance structures in each case. All analyses were completed in SAS 9.4 (SAS Institute Inc.; Cary, NC, USA).|||=0.617
72542652|NCT01864525|144615271|SUPERIORITY|||||||0.0339||||||Statistical results for Magnitude of acoustic frequency tremor. A priori significance threshold was set at P\<0.05 for each of the two hypothesis-driven acoustic variables.|Mixed Models Analysis|This statistical test did not use the baseline scores as a covariate when comparing post-test scores between placebo and octanoic acid conditions.||Separate measures for magnitude of amplitude tremor and magnitude of frequency tremor were analyzed as these variables can respond differently to treatment and may be differentially affected in essential voice tremor. Statistical modeling tested for post-treatment drug differences, with testing session as a repeated factor. Models were run with and without inclusion of baseline averages as a covariate per recommendations for cross-over treatment studies (Fleiss, Wallenstein \& Rosenfeld, 1985).||||0.0339
72572891|NCT03493386|144672874|EQUIVALENCE|If the 90% CI of the ratio of geometric mean doesn't fall within a range of 0.80 to 1.25 i.e., null hypothesis is not rejected the bioequivalence is established if the point estimate falls within a range of 0.90 to 1.11|Ratio of geometric mean|0.91|||||TWO_SIDED|90.0|0.82|1.01|||||AUC (0-inf)|||1.01|0.82|
72572892|NCT03493386|144672875|EQUIVALENCE|If the 90% CI of the ratio of geometric mean doesn't fall within a range of 0.80 to 1.25 i.e., null hypothesis is not rejected the bioequivalence is established if the point estimate falls within a range of 0.90 to 1.11|Ratio of geomtric mean|0.89||||||90.0|0.73|1.08||||||||1.08|0.73|
72572893|NCT05084716|144672926|SUPERIORITY||Odds Ratio (OR)|5.03|||<|0.0001|TWO_SIDED|95.0|2.08|12.13|||Regression, Logistic|||||12.13|2.08|<.0001
72408265|NCT01709318|144324913|OTHER|Based on longitudinal data analysis model: generalized linear mixed model with terms for stratum, ring group, cycle (and the interaction of cycle by ring group), and continuous response variable.|Difference of LS Mean|-0.08||||0.124|||||||LDA|||||||0.124
72408266|NCT01709318|144324913|OTHER|Based on longitudinal data analysis model: generalized linear mixed model with terms for stratum, ring group, cycle (and the interaction of cycle by ring group), and continuous response variable.|Difference of LS Mean|-0.05||||0.845|||||||LDA|||||||0.845
72408267|NCT01709318|144324913|OTHER|Based on longitudinal data analysis model: generalized linear mixed model with terms for stratum, ring group, cycle (and the interaction of cycle by ring group), and continuous response variable.|Difference of LS Mean|-0.04||||0.976|||||||LDA|||||||0.976
72408268|NCT01709318|144324913|OTHER|Based on longitudinal data analysis model: generalized linear mixed model with terms for stratum, ring group, cycle (and the interaction of cycle by ring group), and continuous response variable.|Difference of LS Mean|-0.03||||0.995|||||||LDA|||||||0.995
72408269|NCT01709318|144324914|OTHER|Based on longitudinal data analysis (LDA) model: generalized linear mixed model with terms for stratum, ring group, cycle (and the interaction of cycle by ring group), and continuous response variable.|Difference of Least Squares (LS) Mean|-0.01||||1|||||||LDA|||||||1.000
72534989|NCT03671746|144598834|SUPERIORITY||||||<|0.05|||||||Mixed Models Analysis|A Kenward-Roger adjustment was used to correct for negative bias in the standard errors and degrees of freedom calculations.||Sample size calculations were performed regarding LOS as this was the primary outcome measure. Using a significance level of 0.05 and an assumed SD of 1.5 days, a sample size of 42 patients per group (84 total) would yield 80% power to detect a difference of 0.928 days in average LOS between groups. Allowing for a dropout rate of up to 25%, recruitment was originally planned for 56 patients per group. Power calculations were performed using nQuery 8.5 (Statistical Solutions Ltd; Cork, Ireland).|Group-level summary statistics were calculated for demographic and clinical variables, and differences between groups were evaluated using two-sample t-tests for quantitative measures and Fisher's exact tests for categorical measures, as appropriate. Time and group comparisons for each cytokine were made using linear mixed models, with and without adjusting for selected covariates. Patient demographic variables and clinical outcomes of interest were considered for inclusion as covariates in each model but were only retained if they significantly improved the model. Linear mixed models were log-transformed, double-log-transformed, or square-root-transformed to correct for right skewness, as appropriate. Likelihood ratio testing and Akaike information criterion were used to select appropriate covariance structures in each case. All analyses were completed in SAS 9.4 (SAS Institute Inc.; Cary, NC, USA).|||<0.05
72534990|NCT04410991|144598871|SUPERIORITY|A hierarchical testing procedure was used to control the overall type I error.|Relative risk|0.996||||0.9758|TWO_SIDED|95.0|0.754|1.315||Threshold for significance at 2-sided 0.05 level.|Chi-squared|||Analysis was performed using negative binomial model with number of adjudicated relapses onset between randomization date and EOS date as the response variable, treatment group, Gadolinium (Gd)-enhancing T1 lesions at baseline (presence, absence), expanded disability status scale (EDSS) strata (\<4, \>=4) and geographic region (United States \[US\], non-US) as covariates, and log transformed observation duration as the offset variable.||1.315|0.754|0.9758
72534991|NCT04410991|144598872|SUPERIORITY|A hierarchical testing procedure was used to control the overall type I error.|Hazard Ratio (HR)|0.582||||0.0114|TWO_SIDED|95.0|0.38|0.891||Derived from log-rank test with stratification of EDSS strata (\<4, \>=4), geographic region (US, non-US).|Log Rank|||Analysis was performed using Cox proportional-hazards model with robust variance estimation. Covariates were treatment group, Gd-enhancing T1 lesions at baseline (presence, absence), EDSS strata (\<4, \>=4), geographic region (US, non-US).||0.891|0.380|0.0114
72534992|NCT04410991|144598873|SUPERIORITY|A hierarchical testing procedure was used to control the overall type I error.|Hazard Ratio (HR)|0.641||||0.0181|TWO_SIDED|95.0|0.444|0.925||Derived from log-rank test with stratification of EDSS strata (\<4, \>=4), geographic region (US, non-US).|Log Rank|||Analysis was performed using Cox proportional-hazards model with robust variance estimation. Covariates were treatment group, Gd-enhancing T1 lesions at baseline (presence, absence), EDSS strata (\<4, \>=4), geographic region (US, non-US).||0.925|0.444|0.0181
72534993|NCT04410991|144598874|SUPERIORITY|A hierarchical testing procedure was used to control the overall type I error.|Relative risk|1.165||||0.2362|TWO_SIDED|95.0|0.905|1.502|||Chi-squared|||Analysis was performed using negative binomial model with the number of new and/or enlarging T2-hyperintense lesions between randomization date and EOS date as the response variable, treatment group, baseline T2-hyperintense lesion count, EDSS strata (\<4, \>=4) and geographic region (US, non-US) as covariates, and log transformed observation duration as the offset variable.||1.502|0.905|0.2362
72534994|NCT04410991|144598875|SUPERIORITY|A hierarchical testing procedure was used to control the overall type I error.|Relative risk|2.118|||<|0.0001|TWO_SIDED|95.0|1.502|2.987|||Chi-squared|||Analysis was performed using negative binomial model with the number of new Gd-enhancing T1-hyperintense lesions between randomization date and EOS date as the response variable, treatment group, Gd-enhancing T1 lesions at baseline (presence, absence), EDSS strata (\<4, \>=4) and geographic region (US, non-US) as covariates, and log transformed number of MRI scans as the offset variable.||2.987|1.502|<0.0001
72572894|NCT05084716|144672926|SUPERIORITY||Odds Ratio (OR)|7.6|||<|0.0001|TWO_SIDED|95.0|3.48|16.59|||Regression, Logistic|||||16.59|3.48|<.0001
72408270|NCT01709318|144324914|OTHER|Based on longitudinal data analysis model: generalized linear mixed model with terms for stratum, ring group, cycle (and the interaction of cycle by ring group), and continuous response variable.|Difference of LS Mean|0.19||||0.996|||||||LDA|||||||0.996
72408271|NCT01709318|144324914|OTHER|Based on longitudinal data analysis model: generalized linear mixed model with terms for stratum, ring group, cycle (and the interaction of cycle by ring group), and continuous response variable.|Difference of LS Mean|-0.06||||1|||||||LDA|||||||1.000
72408272|NCT01709318|144324914|OTHER|Based on longitudinal data analysis model: generalized linear mixed model with terms for stratum, ring group, cycle (and the interaction of cycle by ring group), and continuous response variable.|Difference of LS Mean|-0.04||||1|||||||LDA|||||||1.000
72534995|NCT04410991|144598876|SUPERIORITY|A hierarchical testing procedure was used to control the overall type I error.|Least square (LS) mean difference|-0.053||||0.31|TWO_SIDED|95.0|-0.156|0.05|||MMRM|||Covariates in the mixed-effect model with repeated measures (MMRM) were treatment group, EDSS strata (\<4, \>=4), geographic region (US, non-US), visit, treatment by visit interaction, baseline value, and baseline value-by-visit interaction.||0.050|-0.156|0.3100
72572895|NCT05084716|144672927|SUPERIORITY||Odds Ratio (OR)|12.88|||<|0.0001|TWO_SIDED|95.0|5.96|27.85|||Regression, Logistic|||||27.85|5.96|<.0001
72408273|NCT01709318|144324914|OTHER|Based on longitudinal data analysis model: generalized linear mixed model with terms for stratum, ring group, cycle (and the interaction of cycle by ring group), and continuous response variable.|Difference of LS Mean|0.09||||1|||||||LDA|||||||1.000
72572896|NCT05084716|144672927|SUPERIORITY||Odds Ratio (OR)|1.78||||0.001|TWO_SIDED|95.0|1.26|2.52|||Regression, Logistic|||||2.52|1.26|.001
72408274|NCT01709318|144324914|OTHER|Based on longitudinal data analysis model: generalized linear mixed model with terms for stratum, ring group, cycle (and the interaction of cycle by ring group), and continuous response variable.|Difference of LS Mean|-0.24||||0.998|||||||LDA|||||||0.998
72534996|NCT04410991|144598877|SUPERIORITY|A hierarchical testing procedure was used to control the overall type I error.|LS mean difference|-0.612||||0.5235|TWO_SIDED|95.0|-2.493|1.269|||MMRM|||Covariates in the MMRM were treatment group, EDSS strata (\<4, \>=4), geographic region (US, non-US), visit, treatment by visit interaction, baseline value, and baseline value-by-visit interaction.||1.269|-2.493|0.5235
72534997|NCT04410991|144598878|SUPERIORITY|A hierarchical testing procedure was used to control the overall type I error.|Hazard Ratio (HR)|1.652||||0.0079|TWO_SIDED|95.0|1.145|2.383||Derived from log-rank test with stratification of EDSS strata (\<4, \>=4), geographic region (US, non-US).|Log Rank|||Analysis was performed using Cox proportional-hazards model with robust variance estimation. Covariates were treatment group, Gd-enhancing T1 lesions at baseline (presence, absence), EDSS strata (\<4, \>=4), geographic region (US, non-US).||2.383|1.145|0.0079
72534998|NCT04410991|144598879|SUPERIORITY|A hierarchical testing procedure was used to control the overall type I error.|LS mean difference|0.044||||0.4266|TWO_SIDED|95.0|-0.065|0.153|||MMRM|||Covariates in the MMRM were treatment group, EDSS strata (\<4, \>=4), geographic region (US, non-US), visit, treatment by visit interaction, cube root transformed Month 6 brain volume, and cube root transformed Month 6 brain volume-by-visit interaction.||0.153|-0.065|0.4266
72534999|NCT05966129|144598919|SUPERIORITY||Mean Difference (Final Values)|2.8||||0.7957|TWO_SIDED|95.0|-18.3|23.8|||t-test, 2 sided||||Confidence Interval Width = 42.1|23.8|-18.3|0.7957
72535000|NCT05966129|144598920|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.8255|TWO_SIDED|95.0|-0.4|0.5|||t-test, 2 sided||||Confidence Interval Width = 0.9|0.5|-0.4|0.8255
72535001|NCT05966129|144598921|SUPERIORITY|||||||0.9054|||||||Wilcoxon (Mann-Whitney)|||||||0.9054
72535002|NCT05966129|144598922|SUPERIORITY||Mean Difference (Final Values)|-0.7||||0.248|TWO_SIDED|95.0|-1.9|0.5|||t-test, 2 sided||||Confidence Interval Width = 2.4|0.5|-1.9|0.248
72535003|NCT05966129|144598923|SUPERIORITY||Mean Difference (Final Values)|1.0||||0.6012|TWO_SIDED|95.0|-2.7|4.7|||t-test, 2 sided||||Confidence Interval Width = 7.4|4.7|-2.7|0.6012
72535004|NCT05966129|144598924|SUPERIORITY|||||||0.7528|||||||Chi-squared|||||||0.7528
72535005|NCT05966129|144598925|SUPERIORITY||||||<|0.0001|||||||Chi-squared|||||||<0.0001
72535006|NCT01740297|144599055|SUPERIORITY||Odds Ratio (OR)|2.9||||0.002|TWO_SIDED|95.0|1.5|5.5|||Chi-squared, Corrected||Obtained from the unstratified logistic regression model.|||5.5|1.5|0.002
72535007|NCT01740297|144599058|OTHER||Odds Ratio (OR)|1.9||||0.033|TWO_SIDED|95.0|1.1|3.4||P-value is descriptive|Chi-squared, Corrected||Obtained from the unstratified logistic regression model.|||3.4|1.1|0.033
72572897|NCT05084716|144672928|SUPERIORITY||Cohen's d for difference in proportions|1.28|||<|0.0001|TWO_SIDED|||||Odds Ratio is undefined and p-value from Fisher's Exact test is reported because 0% of PrEP users had ≥80% medication coverage pre-intervention.|Fisher Exact|||||||<.0001
72572898|NCT05084716|144672928|SUPERIORITY||Odds Ratio (OR)|0.24|||<|0.0001|TWO_SIDED|95.0|0.16|0.34|||Regression, Logistic|||||0.34|0.16|<.0001
72408275|NCT00600821|144324926|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.093||||0.639|TWO_SIDED|95.0|0.679|1.761||One-sided log-rank test at alpha = 0.20 significance level was used.|Log Rank|||Differences in PFS between treatment arms was analyzed by 1-sided log rank test, stratified by gender and prior adjuvant therapy.||1.761|0.679|0.639
72408276|NCT00600821|144324927|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.117||||0.699|TWO_SIDED|95.0|0.739|1.689||One-sided log-rank test at alpha = 0.20 significance level was used.|Log Rank|||Differences in OS between treatment arms was analyzed by 1-sided log rank test, stratified by gender and prior adjuvant therapy.||1.689|0.739|0.699
72535008|NCT01740297|144599059|OTHER||Odds Ratio (OR)|2.8||||0.007|TWO_SIDED|95.0|1.4|5.8||P-value is descriptive.|Chi-squared, Corrected||Obtained from the unstratified logistic regression model.|||5.8|1.4|0.007
72535009|NCT01740297|144599060|OTHER||Hazard Ratio (HR)|1.41||||0.228|TWO_SIDED|95.0|0.8|2.49||P-value is descriptive|Log Rank||Obtained from unstratified Cox Proportional Hazard Model.|||2.49|0.80|0.228
72535010|NCT01740297|144599062|OTHER||Hazard Ratio (HR)|0.83||||0.348|TWO_SIDED|95.0|0.56|1.23|||Log Rank||Obtained from unstratified Cox Proportional Hazard Model|||1.23|0.56|0.348
72535011|NCT01740297|144599063|OTHER|||||||0.696|||||||Chi-squared, Corrected|||||||0.696
72535012|NCT01740297|144599064|OTHER||Hazard Ratio (HR)|0.8||||0.474|TWO_SIDED|95.0|0.44|1.46|||Log Rank||Obtained from unstratified Cox Proportional Hazard Model|||1.46|0.44|0.474
72535013|NCT01740297|144599066|OTHER||Hazard Ratio (HR)|0.78||||0.14|TWO_SIDED|95.0|0.55|1.09|||Log Rank||Obtained from unstratified Cox Proportional Hazard Model|||1.09|0.55|0.14
72535014|NCT01740297|144599067|OTHER||Hazard Ratio (HR)|0.83||||0.37|TWO_SIDED|95.0|0.56|1.24|||Log Rank||Obtained from unstratified Cox Proportional Hazard Model|||1.24|0.56|0.37
72535015|NCT01966458|144599096|NON_INFERIORITY|A non-inferiority margin of 6% was pre-specified.|Risk Difference (RD)|2.6||||0.1444|TWO_SIDED|90.0|-5.5|10.7|||Farrington-Manning asymptotic test||Difference = HeartWare® VAS incidence rate - Control incidence rate Two-sided 90% exact binomial confident interval is used.|The primary endpoint is a non-inferiority test comparing HeartWare® VAS to Control.||10.7|-5.5|0.1444
72535016|NCT01966458|144599097|SUPERIORITY||Percent of Participants|19.2||||0.7363|TWO_SIDED|90.0|15.6|23.3|||Exact Binomial Test||Two-sided exact binomial confidence interval used|The first secondary endpoint is the percent of participants with stroke/TIA at 12 months on the originally implanted device. It will be compared to 17.7%, which is the lower bound of a pre-defined margin of superiority based on the Endurance clinical trial.||23.3|15.6|0.7363
72535017|NCT01966458|144599098|NON_INFERIORITY|The non-inferiority margin on the difference in success proportions is 15%.|Difference in Percentages|-9.2|||<|0.0001|TWO_SIDED|90.0|-17.2|-1.1|||Farrington-Manning asymptotic test||Difference = Control success rate - HeartWare® VAS success rate Two-sided 90% exact binomial confidence interval is used|||-1.1|-17.2|<0.0001
72535018|NCT01966458|144599098|SUPERIORITY|||||||0.0354|||||||Chi-squared|||||||0.0354
72535019|NCT02389621|144599099|SUPERIORITY||Difference|36.7|||<|0.0001|TWO_SIDED|95.0|24.9|48.5||Statistical tests were performed at a 2-sided significance level of 0.05.|Cochran-Mantel-Haenszel|Adjusted using the stratification factors of platelet count at randomization and the planned primary invasive procedure.||||48.5|24.9|<0.0001
72535020|NCT02389621|144599100|SUPERIORITY|A gatekeeping procedure was employed for sequentially testing the prespecified important secondary endpoints, identified as the most clinically relevant endpoints. If the primary endpoint was statistically significant, the secondary endpoints were tested at the 0.05 level (2-sided) in sequence.|Difference|34.8|||<|0.0001|TWO_SIDED|95.0|22.8|46.8|||Cochran-Mantel-Haenszel|Adjusted for the stratification factors of platelet count at randomization and the planned primary invasive procedure.||||46.8|22.8|<0.0001
72535021|NCT02389621|144599101|SUPERIORITY|A gatekeeping procedure was employed for sequentially testing the prespecified important secondary endpoints, identified as the most clinically relevant endpoints. If the primary endpoint was statistically significant, the secondary endpoints were tested at the 0.05 level (2-sided) in sequence.|Difference|52.5|||<|0.0001|TWO_SIDED|95.0|42.0|62.9|||Cochran-Mantel-Haenszel|Adjusted for the stratification factors of platelet count at randomization and the planned primary invasive procedure.||||62.9|42.0|<0.0001
72535022|NCT02389621|144599102|SUPERIORITY|A gatekeeping procedure was employed for sequentially testing the prespecified important secondary endpoints, identified as the most clinically relevant endpoints. If the primary endpoint was statistically significant, the secondary endpoints were tested at the 0.05 level (2-sided) in sequence.||||||0.0002|||||||van Elteren test|van Elteren test stratified by platelet transfusion during the study.||||||0.0002
72535023|NCT02389621|144599103|SUPERIORITY|A gatekeeping procedure was employed for sequentially testing the prespecified important secondary endpoints, identified as the most clinically relevant endpoints. If the primary endpoint was statistically significant, the secondary endpoints were tested at the 0.05 level (2-sided) in sequence.|||||<|0.0001|||||||Wilcoxon rank sum test|||||||<0.0001
72535024|NCT00620776|144599121|SUPERIORITY_OR_OTHER|||||||0.17|||||||Mixed Models Analysis|||Mixed model analysis (differential slopes over time) comparing the 26 patients who received combined treatment with at least one CBT session to the 35 patients randomized to venlafaxine XR alone (and received at least one dose) on HAM-A total scores. Only available scores were used (no imputation for missing data). Because the HAM-A demonstrated a relatively rapid improvement early in treatment and then a leveling off, a shifted log-transformation of time of assessment was implemented.||||.17
72535025|NCT00620776|144599122|SUPERIORITY_OR_OTHER|||||||0.54|||||||Mixed Models Analysis|||Analyses were conducted using mixed effects models that tested for differential slopes over time between the CBT plus venlafaxine XR and venlafaxine XR alone groups using only available scores (no imputation for missing data).||||.54
72535026|NCT00620776|144599123|SUPERIORITY_OR_OTHER|||||||0.86|||||||Mixed Models Analysis|||Analyses were conducted using mixed effects models that tested for differential slopes over time between the CBT plus venlafaxine XR and venlafaxine XR alone groups using only available scores (no imputation for missing data).||||.86
72535027|NCT00620776|144599124|SUPERIORITY_OR_OTHER|||||||0.051|||||||ANCOVA|||Data collected at week 24 were analyzed using analysis of covariance (ANCOVA) with the baseline score as the covariate.||||.051
72535028|NCT00620776|144599125|SUPERIORITY_OR_OTHER|||||||0.06|||||||ANCOVA|||Analyses were conducted using mixed effects models that tested for differential slopes over time between the CBT plus venlafaxine XR and venlafaxine XR alone groups using only available scores (no imputation for missing data).||||.06
72535029|NCT00620776|144599126|SUPERIORITY_OR_OTHER|||||||0.95|||||||Mixed Models Analysis|||Analyses were conducted using mixed effects models that tested for differential slopes over time between the CBT plus venlafaxine XR and venlafaxine XR alone groups using only available scores (no imputation for missing data).||||.95
72572899|NCT01974440|144672948|SUPERIORITY||Hazard Ratio (HR)|0.806||||0.0922|TWO_SIDED|95.0|0.626|1.037|||Log Rank|||||1.037|0.626|0.0922
72626571|NCT01576783|144781969|OTHER|The reported p-value is for the comparison of the scores between groups (DHA+AA vs. Placebo) at the end of the trial.||||||0.68||||||Threshold for statistical significance (\<0.05).|Mixed Models Analysis|Continuous scores at the end of the trial were compared using a linear mixed model.||||||0.68
72535030|NCT00620776|144599127|SUPERIORITY_OR_OTHER|||||||0.17|||||||ANCOVA|||Data collected at week 24 were analyzed using ANCOVA with the baseline score as the covariate.||||.17
72535031|NCT00620776|144599128|SUPERIORITY_OR_OTHER|||||||0.53|||||||ANCOVA|||Data collected at week 24 were analyzed using ANCOVA with the baseline score as the covariate.||||.53
72572900|NCT01974440|144672949|SUPERIORITY||Hazard Ratio (HR)|0.725||||0.4505|TWO_SIDED|95.0|0.312|1.682|||Log Rank|||||1.682|0.312|0.4505
72572901|NCT06354998|144672971|OTHER||Geometric Mean Ratio (GMR)|0.908|||||TWO_SIDED|95.0|0.662|1.245|||||GMR was a secondary endpoint.|GMR (mRNA-1273.815 versus licensed Spikevax) at Day 15 and its 95% CI was calculated based on the t-distribution for the mean difference of log-transformed antibody values and then back transformed to the original scale for presentation.||1.245|0.662|
72572902|NCT04795908|144672974|NON_INFERIORITY|looking for statistical significant differences between groups||||||0.1997|||||||ANOVA|||||||0.1997
72572903|NCT04795908|144672975|NON_INFERIORITY|looking for statistical significant differences between groups||||||0.076|||||||ANOVA|||||||0.076
72626572|NCT01576783|144781969|OTHER|The reported p-value is for the comparison of the scores between groups (DHA+AA vs. Placebo) at the end of the trial.||||||0.78||||||Threshold for statistical significance (\<0.05).|Mixed Models Analysis|Continuous scores at the end of the trial were compared using a linear mixed model.||||||0.78
72535032|NCT00620776|144599129|SUPERIORITY_OR_OTHER|||||||0.23|||||||ANCOVA|||Data collected at week 24 were analyzed with ANCOVA with baseline data as covariate.||||.23
72535033|NCT00620776|144599130|SUPERIORITY_OR_OTHER|||||||0.07|||||||ANCOVA|||Data collected at week 24 were analyzed with ANCOVA including baseline data as covariate.||||.07
72535034|NCT00620776|144599131|SUPERIORITY_OR_OTHER|||||||0.63|||||||Chi-squared|||||||.63
72535035|NCT00620776|144599132|SUPERIORITY_OR_OTHER|||||||0.52|||||||Chi-squared|||||||.52
72535036|NCT03992456|144599159|SUPERIORITY|||||||0.5126|||||||Un-Stratified Log-rank|||||||0.5126
72535037|NCT03992456|144599160|SUPERIORITY|||||||0.1512|||||||Un-Stratified Log-rank|||||||0.1512
72535038|NCT03992456|144599161|SUPERIORITY|||||||0.2506|||||||Chi-squared|||||||0.2506
72535039|NCT03992456|144599162|SUPERIORITY|||||||0.8865|||||||Chi-squared|||||||0.8865
72535040|NCT03992456|144599163|SUPERIORITY|||||||0.5455|||||||Fisher Exact|||||||0.5455
72535041|NCT04668066|144599259|OTHER||Least Square Mean Difference|5.6||||0.6343|TWO_SIDED|90.0|-21.4|32.6|||ANCOVA|||||32.6|-21.4|0.6343
72535042|NCT02276274|144599260|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.0164|||||TWO_SIDED|90.0|-0.0592|0.0264|||||Analysis of variance (ANOVA) was performed on log-transformed values of AUC (0-72) with regimen, treatment group (treatment sequence), and treatment period as fixed effects.|||0.0264|-0.0592|
72408277|NCT00600821|144324928|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.676||||0.9422|TWO_SIDED|95.0|0.412|1.107|||Cochran-Mantel-Haenszel|||P-value was calculated using 1-sided Cochran-Mantel-Haenszel test stratified by gender and prior adjuvant therapy. Risk ratio in comparison to the Bevacizumab group was calculated assuming all other factors as constant.||1.107|0.412|0.9422
72535043|NCT02276274|144599261|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.0164|||||TWO_SIDED|90.0|-0.0592|0.0264|||||ANOVA was performed on log-transformed values of AUC (0-tlqc) with regimen, treatment group (treatment sequence), and treatment period as fixed effects.|||0.0264|-0.0592|
72535044|NCT02276274|144599262|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|0.1182|||||TWO_SIDED|90.0|-0.0405|0.2769|||||ANOVA was performed on log-transformed values of Cmax with regimen, treatment group (treatment sequence), and treatment period as fixed effects.|||0.2769|-0.0405|
72535045|NCT02276274|144599264|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.0139|||||TWO_SIDED|90.0|-0.0598|0.032|||||ANOVA was performed on log-transformed values of AUC (0-inf) with regimen, treatment group (treatment sequence), and treatment period as fixed effects.|||0.0320|-0.0598|
72535046|NCT02276274|144599279|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.014|||||TWO_SIDED|90.0|-0.0918|0.0638|||||ANOVA was performed on log-transformed values of AUC (0-48) with regimen, treatment group (treatment sequence), and treatment period as fixed effects.|||0.0638|-0.0918|
72535047|NCT02276274|144599280|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.0164|||||TWO_SIDED|90.0|-0.0934|0.0605|||||ANOVA was performed on log-transformed values of AUC (0-tlqc) with regimen, treatment group (treatment sequence), and treatment period as fixed effects.|||0.0605|-0.0934|
72535048|NCT02276274|144599282|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.1518|||||TWO_SIDED|90.0|-0.2356|-0.068|||||ANOVA was performed on log-transformed values of Cmax with regimen, treatment group (treatment sequence), and treatment period as fixed effects.|||-0.0680|-0.2356|
72535049|NCT02276274|144599284|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.0179|||||TWO_SIDED|90.0|-0.095|0.0591|||||ANOVA was performed on log-transformed values of AUC (0-inf) with regimen, treatment group (treatment sequence), and treatment period as fixed effects.|||0.0591|-0.0950|
72535050|NCT01015118|144599390|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.84||||0.0239|TWO_SIDED|95.0|0.72|0.98|||Log Rank|Breslow method was used for handling ties.|If hazard ratio is below 1 then favours nintedanib.|Hazard ratio (HR), Confidence Interval (CI) and P-value obtained from a proportional-hazards model stratified by Macroscopic residual postoperative tumour (Yes vs. no), the International Federation of Gynecology and Obstetrics (FIGO) Stage (IIB-III vs. IV) and carboplatin level Area under curve 5 (AUC5) vs. Area under curve 6 (AUC6).||0.98|0.72|0.0239
72535051|NCT01015118|144599391|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.86||||0.0286|TWO_SIDED|95.0|0.75|0.98|||Log Rank|Breslow method was used for handling ties.|If hazard ratio is below 1 then favours nintedanib.|Hazard ratio (HR), Confidence Interval (CI) and P-value obtained from a proportional-hazards model stratified by Macroscopic residual postoperative tumour (Yes vs. no), the International Federation of Gynecology and Obstetrics (FIGO) Stage (IIB-III vs. IV) and carboplatin level (AUC5 vs. AUC6).||0.98|0.75|0.0286
72572904|NCT04795908|144672976|NON_INFERIORITY|looking for statistically significant differences between groups||||||0.6228|||||||ANOVA|||||||0.6228
72535052|NCT01015118|144599392|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.83||||0.0186|TWO_SIDED|95.0|0.72|0.97|||Log Rank|Breslow method was used for handling ties.|If hazard ratio is below 1 then favours nintedanib.|HR, CI and P-value obtained from a proportional-hazards model stratified by Macroscopic residual postoperative tumour (Yes vs. no), the International Federation of Gynecology and Obstetrics (FIGO) Stage (IIB-III vs. IV) and carboplatin level (AUC5 vs. AUC6).||0.97|0.72|0.0186
72535053|NCT01015118|144599393|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.85||||0.0256|TWO_SIDED|95.0|0.74|0.98|||Log Rank|Breslow method was used for handling ties.|If hazard ratio is below 1 then favours nintedanib.|HR, CI and P-value obtained from a proportional-hazards model stratified by Macroscopic residual postoperative tumour (Yes vs. no), the International Federation of Gynecology and Obstetrics (FIGO) Stage (IIB-III vs. IV) and carboplatin level (AUC5 vs. AUC6).||0.98|0.74|0.0256
72535054|NCT01015118|144599394|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.99||||0.8653|TWO_SIDED|95.0|0.83|1.17|||Log Rank|Breslow method was used for handling ties.|If hazard ratio is below 1 then favours nintedanib.|HR, CI and P-value obtained from a proportional-hazards model stratified by Macroscopic residual postoperative tumour (Yes vs. no), the International Federation of Gynecology and Obstetrics (FIGO) Stage (IIB-III vs. IV) and carboplatin level (AUC5 vs. AUC6).||1.17|0.83|0.8653
72535055|NCT01015118|144599395|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.88||||0.0749|TWO_SIDED|95.0|0.77|1.01|||Log Rank|Breslow method was used for handling ties.|If hazard ratio is below 1 then favours nintedanib.|HR, CI and P-value obtained from a proportional-hazards model stratified by Macroscopic residual postoperative tumour (Yes vs. no), the International Federation of Gynecology and Obstetrics (FIGO) Stage (IIB-III vs. IV) and carboplatin level (AUC5 vs. AUC6).||1.01|0.77|0.0749
72535056|NCT01015118|144599396|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.22||||0.349|TWO_SIDED|95.0|0.81|1.82|||Regression, Logistic||An odds ratio \>1 favours nintedanib.|Odds ratio and p-value are obtained from logistic regression model adjusting for, macroscopic residual postoperative tumour (yes vs. no), the International Federation of Gynecology and Obstetrics (FIGO) stage (IIB-III vs. IV) and carboplatin level (AUC5 vs. AUC6).||1.82|0.81|0.3490
72572905|NCT04795908|144672977|NON_INFERIORITY|looking for statistically significant differences between groups||||||0.8984|||||||ANOVA|||||||0.8984
72572906|NCT04795908|144672978|NON_INFERIORITY|looking for statistically significant differences between groups||||||0.8188|||||||ANOVA|||||||0.8188
72572907|NCT04795908|144672979|NON_INFERIORITY|Looking for statistically significant differences between groups||||||0.0288|||||||ANOVA|||||||0.0288
72572908|NCT04795908|144672980|NON_INFERIORITY|looking for statistically significant differences between groups||||||0.0524|||||||ANOVA|||||||0.0524
72572909|NCT02800213|144672990|SUPERIORITY|||||||0.28|||||||t-test, 2 sided|||||||0.280
72572910|NCT01948986|144672997|SUPERIORITY_OR_OTHER||Ratio (Heathy Normal/T2DM Normal)|103.07|||||TWO_SIDED|90.0|80.32|132.27|||||The model was an ANOVA model with renal function group as a fixed effect. The ratios (and 90% CIs) are expressed as percentages.|||132.27|80.32|
72572911|NCT01948986|144672997|SUPERIORITY_OR_OTHER||Ratio (Mild Renal Impair./Pooled Norm.)|156.34|||||TWO_SIDED|90.0|127.83|191.23|||||The model was an ANOVA model with renal function group as a fixed effect. The ratios (and 90% CIs) are expressed as percentages.|||191.23|127.83|
72535057|NCT01015118|144599397|SUPERIORITY_OR_OTHER||Mean Difference (Net)|5.29|STANDARD_ERROR_OF_MEAN|0.72|<|0.0001|TWO_SIDED|95.0|3.88|6.69|||Mixed effect growth curve model|Mixed-effects growth curve models (longitudinal models) with the average profile over time for each endpoint described by a piecewise linear model.|Mean difference presented is the Adjusted mean difference. Difference calculated as nintedanib minus placebo. High values represent a worse level of symptoms.|Adjusted for the stratification factors macroscopic residual postoperative tumour at baseline (yes vs. no), the International Federation of Gynecology and Obstetrics (FIGO) stage (IIB-III vs IV), and carboplatin level (AUC5 vs. AUC6).||6.69|3.88|<0.0001
72535058|NCT01015118|144599398|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.88|STANDARD_ERROR_OF_MEAN|0.75||0.0124|TWO_SIDED|95.0|-3.35|-0.41|||Mixed effect growth curve model|Mixed-effects growth curve models (longitudinal models) with the average profile over time for each endpoint described by a piecewise linear model.|Mean difference calculated is the Adjusted mean. High values represent a better level of functioning. Difference calculated as nintedanib minus placebo.|Adjusted for the stratification factors macroscopic residual postoperative tumour at baseline (yes vs. no), the International Federation of Gynecology and Obstetrics (FIGO) stage (IIB-III vs IV), and carboplatin level (AUC5 vs. AUC6).||-0.41|-3.35|0.0124
72535059|NCT03522506|144599399|SUPERIORITY|The effect of TAK-925 was evaluated with a linear mixed effects model appropriate for a 4-period crossover study. The least squares mean (LSM) sleep latency for each treatment and the associated standard error and 95% confidence interval (CI) was estimated from the model at each time, along with differences between active treatments and placebo, and associated standard errors, 95% CIs, and p-values.|Least square mean difference|20.06|||<|0.001|TWO_SIDED|95.0|13.35|26.77|||Linear mixed effect model|||||26.77|13.35|<0.001
72535060|NCT03522506|144599399|SUPERIORITY|The effect of TAK-925 was evaluated with a linear mixed effects model appropriate for a 4-period crossover study. The LSM sleep latency for each treatment and the associated standard error and 95% CI was estimated from the model at each time, along with differences between active treatments and placebo, and associated standard errors, 95% CIs, and p-values.|LSM difference|24.35|||<|0.001|TWO_SIDED|95.0|17.64|31.06|||Linear mixed effect model|||||31.06|17.64|<0.001
72535061|NCT03522506|144599399|SUPERIORITY|The effect of TAK-925 was evaluated with a linear mixed effects model appropriate for a 4-period crossover study. The LSM sleep latency for each treatment and the associated standard error and 95% CI was estimated from the model at each time, along with differences between active treatments and placebo, and associated standard errors, 95% CIs, and p-values.|LSM Difference|19.89|||<|0.001|TWO_SIDED|95.0|13.3|26.49|||Linear mixed effects model|||||26.49|13.30|<0.001
72535062|NCT03522506|144599409|SUPERIORITY|14 hours pre-infusion: A linear mixed effect models was performed for all observed KSS parameters at scheduled time points. The LSM sleepless scale for each treatment and the associated standard error and 95% CI was estimated from the model at each time point, along with the differences between active treatments and placebo, and associated standard errors, 95% CIs, and p-values.|LSM difference|-0.2||||0.664|TWO_SIDED|95.0|-1.13|0.73|||Linear mixed effect model|||||0.73|-1.13|0.664
72535063|NCT03522506|144599409|SUPERIORITY|14 hours pre-infusion: A linear mixed effect models was performed for all observed KSS parameters at scheduled time points. The LSM sleepless scale for each treatment and the associated standard error and 95% CI was estimated from the model at each time point, along with the differences between active treatments and placebo, and associated standard errors, 95% CIs, and p-values.|LSM difference|0.24||||0.605|TWO_SIDED|95.0|-0.69|1.17|||Linear mixed effect model|||||1.17|-0.69|0.605
72535064|NCT03522506|144599409|SUPERIORITY|14 hours pre-infusion: A linear mixed effect models was performed for all observed KSS parameters at scheduled time points. The LSM sleepless scale for each treatment and the associated standard error and 95% CI was estimated from the model at each time point, along with the differences between active treatments and placebo, and associated standard errors, 95% CIs, and p-values.|LSM difference|-0.26||||0.574|TWO_SIDED|95.0|-1.17|0.66|||Linear mixed effect model|||||0.66|-1.17|0.574
72535065|NCT03522506|144599409|SUPERIORITY|10 hours pre-infusion: A linear mixed effect models was performed for all observed KSS parameters at scheduled time points. The LSM sleepless scale for each treatment and the associated standard error and 95% CI was estimated from the model at each time point, along with the differences between active treatments and placebo, and associated standard errors, 95% CIs, and p-values.|LSM difference|0.29||||0.483|TWO_SIDED|95.0|-0.53|1.11|||Linear mixed effect model|||||1.11|-0.53|0.483
72535066|NCT03522506|144599409|SUPERIORITY|10 hours pre-infusion: A linear mixed effect models was performed for all observed KSS parameters at scheduled time points. The LSM sleepless scale for each treatment and the associated standard error and 95% CI was estimated from the model at each time point, along with the differences between active treatments and placebo, and associated standard errors, 95% CIs, and p-values.|LSM difference|0.01||||0.972|TWO_SIDED|95.0|-0.81|0.84|||Linear mixed effect model|||||0.84|-0.81|0.972
72572912|NCT01948986|144672997|SUPERIORITY_OR_OTHER||Ratio (Mod. Renal Impair./Pooled Norm.)|170.04|||||TWO_SIDED|90.0|139.02|207.98|||||The model was an ANOVA model with renal function group as a fixed effect. The ratios (and 90% CIs) are expressed as percentages.|||207.98|139.02|
72572913|NCT01948986|144672997|SUPERIORITY_OR_OTHER||Ratio (Severe Renal Impair./Pooled Norm.|155.26|||||TWO_SIDED|90.0|124.38|193.8|||||The model was an ANOVA model with renal function group as a fixed effect. The ratios (and 90% CIs) are expressed as percentages.|||193.80|124.38|
72535067|NCT03522506|144599409|SUPERIORITY|10 hours pre-infusion: A linear mixed effect models was performed for all observed KSS parameters at scheduled time points. The LSM sleepless scale for each treatment and the associated standard error and 95% CI was estimated from the model at each time point, along with the differences between active treatments and placebo, and associated standard errors, 95% CIs, and p-values.|LSM difference|-0.18||||0.654|TWO_SIDED|95.0|-0.99|0.63|||Linear mixed effect model|||||0.63|-0.99|0.654
72535068|NCT03522506|144599409|SUPERIORITY|6 hours pre-infusion: A linear mixed effect models was performed for all observed KSS parameters at scheduled time points. The LSM sleepless scale for each treatment and the associated standard error and 95% CI was estimated from the model at each time point, along with the differences between active treatments and placebo, and associated standard errors, 95% CIs, and p-values.|LSM difference|-0.01||||0.984|TWO_SIDED|95.0|-0.86|0.85|||Linear mixed effect model|||||0.85|-0.86|0.984
72535069|NCT03522506|144599409|SUPERIORITY|6 hours pre-infusion: A linear mixed effect models was performed for all observed KSS parameters at scheduled time points. The LSM sleepless scale for each treatment and the associated standard error and 95% CI was estimated from the model at each time point, along with the differences between active treatments and placebo, and associated standard errors, 95% CIs, and p-values.|LSM difference|-0.29||||0.508|TWO_SIDED|95.0|-1.14|0.57|||Linear mixed effect model|||||0.57|-1.14|0.508
72535070|NCT03522506|144599409|SUPERIORITY|6 hours pre-infusion: A linear mixed effect models was performed for all observed KSS parameters at scheduled time points. The LSM sleepless scale for each treatment and the associated standard error and 95% CI was estimated from the model at each time point, along with the differences between active treatments and placebo, and associated standard errors, 95% CIs, and p-values.|LSM difference|-0.22||||0.605|TWO_SIDED|95.0|-1.06|0.62|||Linear mixed effect model|||||0.62|-1.06|0.605
72535071|NCT03522506|144599409|SUPERIORITY|2 hours pre-infusion: A linear mixed effect models was performed for all observed KSS parameters at scheduled time points. The LSM sleepless scale for each treatment and the associated standard error and 95% CI was estimated from the model at each time point, along with the differences between active treatments and placebo, and associated standard errors, 95% CIs, and p-values.|LSM difference|0.11||||0.847|TWO_SIDED|95.0|-1.06|1.29|||Linear mixed effect model|||||1.29|-1.06|0.847
72535072|NCT03522506|144599409|SUPERIORITY|2 hours pre-infusion: A linear mixed effect models was performed for all observed KSS parameters at scheduled time points. The LSM sleepless scale for each treatment and the associated standard error and 95% CI was estimated from the model at each time point, along with the differences between active treatments and placebo, and associated standard errors, 95% CIs, and p-values.|LSM difference|-0.44||||0.455|TWO_SIDED|95.0|-1.61|0.73|||Linear mixed effect model|||||0.73|-1.61|0.455
72535073|NCT03522506|144599409|SUPERIORITY|2 hours pre-infusion: A linear mixed effect models was performed for all observed KSS parameters at scheduled time points. The LSM sleepless scale for each treatment and the associated standard error and 95% CI was estimated from the model at each time point, along with the differences between active treatments and placebo, and associated standard errors, 95% CIs, and p-values.|LSM difference|-0.58||||0.317|TWO_SIDED|95.0|-1.74|0.57|||Linear mixed effect model|||||0.57|-1.74|0.317
72535074|NCT03522506|144599409|SUPERIORITY|2.75 hours post-infusion start: A linear mixed effect models was performed for all observed KSS parameters at scheduled time points. The LSM sleepless scale for each treatment and the associated standard error and 95% CI was estimated from the model at each time point, along with the differences between active treatments and placebo, and associated standard errors, 95% CIs, and p-values.|LSM difference|-2.0||||0.001|TWO_SIDED|95.0|-3.18|-0.83|||Linear mixed effect model|||||-0.83|-3.18|0.001
72535075|NCT03522506|144599409|SUPERIORITY|2.75 hours post-infusion start: A linear mixed effect models was performed for all observed KSS parameters at scheduled time points. The LSM sleepless scale for each treatment and the associated standard error and 95% CI was estimated from the model at each time point, along with the differences between active treatments and placebo, and associated standard errors, 95% CIs, and p-values.|LSM difference|-3.61|||<|0.001|TWO_SIDED|95.0|-4.79|-2.44|||Linear mixed effect model|||||-2.44|-4.79|<0.001
72535076|NCT03522506|144599409|SUPERIORITY|2.75 hours post-infusion start: A linear mixed effect models was performed for all observed KSS parameters at scheduled time points. The LSM sleepless scale for each treatment and the associated standard error and 95% CI was estimated from the model at each time point, along with the differences between active treatments and placebo, and associated standard errors, 95% CIs, and p-values.|LSM difference|-3.16|||<|0.001|TWO_SIDED|95.0|-4.32|-2.01|||Linear mixed effect model|||||-2.01|-4.32|<0.001
72535077|NCT03522506|144599409|SUPERIORITY|4.75 hours post-infusion start: A linear mixed effect models was performed for all observed KSS parameters at scheduled time points. The LSM sleepless scale for each treatment and the associated standard error and 95% CI was estimated from the model at each time point, along with the differences between active treatments and placebo, and associated standard errors, 95% CIs, and p-values.|LSM difference|-1.69||||0.003|TWO_SIDED|95.0|-2.78|-0.6|||Linear mixed effect model|||||-0.60|-2.78|0.003
72535078|NCT03522506|144599409|SUPERIORITY|4.75 hours post-infusion start: A linear mixed effect models was performed for all observed KSS parameters at scheduled time points. The LSM sleepless scale for each treatment and the associated standard error and 95% CI was estimated from the model at each time point, along with the differences between active treatments and placebo, and associated standard errors, 95% CIs, and p-values.|LSM difference|-4.3|||<|0.001|TWO_SIDED|95.0|-5.39|-3.21|||Linear mixed effect model|||||-3.21|-5.39|<0.001
72535079|NCT03522506|144599409|SUPERIORITY|4.75 hours post-infusion start: A linear mixed effect models was performed for all observed KSS parameters at scheduled time points. The LSM sleepless scale for each treatment and the associated standard error and 95% CI was estimated from the model at each time point, along with the differences between active treatments and placebo, and associated standard errors, 95% CIs, and p-values.|LSM difference|-3.83|||<|0.001|TWO_SIDED|95.0|-4.91|-2.76|||Linear mixed effect model|||||-2.76|-4.91|<0.001
72535080|NCT03522506|144599409|SUPERIORITY|6.75 hours post-infusion start: A linear mixed effect models was performed for all observed KSS parameters at scheduled time points. The LSM sleepless scale for each treatment and the associated standard error and 95% CI was estimated from the model at each time point, along with the differences between active treatments and placebo, and associated standard errors, 95% CIs, and p-values.|LSM difference|-0.71||||0.13|TWO_SIDED|95.0|-1.63|0.21|||Linear mixed effect model|||||0.21|-1.63|0.130
72408278|NCT04304001|144324942|SUPERIORITY||||||<|0.05|||||||Chi-squared|||For each arm, the proportion of participants who receive colorectal cancer screening by 12 months was computed. The chi-square test was used to compare the two treatment arms for screening receipt. If the proportion of participants receiving colorectal cancer screening in the intervention arm is at least 15% higher than that in the control arm, the intervention was determined to be effective.||||<0.05
72535081|NCT03522506|144599409|SUPERIORITY|6.75 hours post-infusion start: A linear mixed effect models was performed for all observed KSS parameters at scheduled time points. The LSM sleepless scale for each treatment and the associated standard error and 95% CI was estimated from the model at each time point, along with the differences between active treatments and placebo, and associated standard errors, 95% CIs, and p-values.|LSM difference|-3.32|||<|0.001|TWO_SIDED|95.0|-4.24|-2.4|||Linear mixed effect model|||||-2.40|-4.24|<0.001
72535082|NCT03522506|144599409|SUPERIORITY|6.75 hours post-infusion start: A linear mixed effect models was performed for all observed KSS parameters at scheduled time points. The LSM sleepless scale for each treatment and the associated standard error and 95% CI was estimated from the model at each time point, along with the differences between active treatments and placebo, and associated standard errors, 95% CIs, and p-values.|LSM difference|-2.71|||<|0.001|TWO_SIDED|95.0|-3.62|-1.8|||Linear mixed effect model|||||-1.80|-3.62|<0.001
72535083|NCT03522506|144599409|SUPERIORITY|8.75 hours post-infusion start: A linear mixed effect models was performed for all observed KSS parameters at scheduled time points. The LSM sleepless scale for each treatment and the associated standard error and 95% CI was estimated from the model at each time point, along with the differences between active treatments and placebo, and associated standard errors, 95% CIs, and p-values.|LSM difference|-0.26||||0.577|TWO_SIDED|95.0|-1.2|0.68|||Linear mixed effect model|||||0.68|-1.20|0.577
72535084|NCT03522506|144599409|SUPERIORITY|8.75 hours post-infusion start: A linear mixed effect models was performed for all observed KSS parameters at scheduled time points. The LSM sleepless scale for each treatment and the associated standard error and 95% CI was estimated from the model at each time point, along with the differences between active treatments and placebo, and associated standard errors, 95% CIs, and p-values.|LSM difference|-2.26|||<|0.001|TWO_SIDED|95.0|-3.2|-1.32|||Linear mixed effect model|||||-1.32|-3.20|<0.001
72535085|NCT03522506|144599409|SUPERIORITY|8.75 hours post-infusion start: A linear mixed effect models was performed for all observed KSS parameters at scheduled time points. The LSM sleepless scale for each treatment and the associated standard error and 95% CI was estimated from the model at each time point, along with the differences between active treatments and placebo, and associated standard errors, 95% CIs, and p-values.|LSM difference|-1.65|||<|0.001|TWO_SIDED|95.0|-2.57|-0.72|||Linear mixed effect model|||||-0.72|-2.57|<0.001
72535086|NCT03522506|144599409|SUPERIORITY|1.75 hours post-infusion end: A linear mixed effect models was performed for all observed KSS parameters at scheduled time points. The LSM sleepless scale for each treatment and the associated standard error and 95% CI was estimated from the model at each time point, along with the differences between active treatments and placebo, and associated standard errors, 95% CIs, and p-values.|LSM difference|0.31||||0.475|TWO_SIDED|95.0|-0.55|1.16|||Linear mixed effect model|||||1.16|-0.55|0.475
72535087|NCT03522506|144599409|SUPERIORITY|1.75 hours post-infusion end: A linear mixed effect models was performed for all observed KSS parameters at scheduled time points. The LSM sleepless scale for each treatment and the associated standard error and 95% CI was estimated from the model at each time point, along with the differences between active treatments and placebo, and associated standard errors, 95% CIs, and p-values.|LSM difference|-0.14||||0.753|TWO_SIDED|95.0|-0.99|0.72|||Linear mixed effect model|||||0.72|-0.99|0.753
72572914|NCT01948986|144672998|SUPERIORITY_OR_OTHER||Ratio (Heathy Normal/T2DM Normal)|103.42|||||TWO_SIDED|90.0|80.66|132.61|||||The model was an ANOVA model with renal function group as a fixed effect. The ratios (and 90% CIs) are expressed as percentages.|||132.61|80.66|
72535088|NCT03522506|144599409|SUPERIORITY|1.75 hours post-infusion end: A linear mixed effect models was performed for all observed KSS parameters at scheduled time points. The LSM sleepless scale for each treatment and the associated standard error and 95% CI was estimated from the model at each time point, along with the differences between active treatments and placebo, and associated standard errors, 95% CIs, and p-values.|LSM difference|-0.99||||0.022|TWO_SIDED|95.0|-1.83|-0.15|||Linear mixed effect model|||||-0.15|-1.83|0.022
72535089|NCT03522506|144599410|SUPERIORITY|The effect of TAK-925 was evaluated with a linear mixed effects model appropriate for a 4-period crossover study. The LSM sleep latency for each treatment and the associated standard error and 95% CI was estimated from the model at each time, along with differences between active treatments and placebo, and associated standard errors, 95% CIs, and p-values.|LSM difference|22.94|||<|0.001|TWO_SIDED|95.0|16.58|29.3|||Linear mixed effect model|||||29.30|16.58|<0.001
72572915|NCT01948986|144672998|SUPERIORITY_OR_OTHER||Ratio (Mild Renal Impair./Pooled Norm.)|151.63|||||TWO_SIDED|90.0|124.05|185.34|||||The model was an ANOVA model with renal function group as a fixed effect. The ratios (and 90% CIs) are expressed as percentages.|||185.34|124.05|
72572916|NCT01948986|144672998|SUPERIORITY_OR_OTHER||Ratio (Mod. Renal Impair./Pooled Norm.)|168.11|||||TWO_SIDED|90.0|137.53|205.49|||||The model was an ANOVA model with renal function group as a fixed effect. The ratios (and 90% CIs) are expressed as percentages.|||205.49|137.53|
72572917|NCT01948986|144672998|SUPERIORITY_OR_OTHER||Ratio (Severe Renal Impair./Pooled Norm.|151.8|||||TWO_SIDED|90.0|121.69|189.36|||||The model was an ANOVA model with renal function group as a fixed effect. The ratios (and 90% CIs) are expressed as percentages.|||189.36|121.69|
72535090|NCT03522506|144599410|SUPERIORITY|The effect of TAK-925 was evaluated with a linear mixed effects model appropriate for a 4-period crossover study. The LSM sleep latency for each treatment and the associated standard error and 95% CI was estimated from the model at each time, along with differences between active treatments and placebo, and associated standard errors, 95% CIs, and p-values.|LSM difference|30.95|||<|0.001|TWO_SIDED|95.0|24.59|37.31|||Linear mixed effects model|||||37.31|24.59|<0.001
72535091|NCT03522506|144599410|SUPERIORITY|The effect of TAK-925 was evaluated with a linear mixed effects model appropriate for a 4-period crossover study. The LSM sleep latency for each treatment and the associated standard error and 95% CI was estimated from the model at each time, along with differences between active treatments and placebo, and associated standard errors, 95% CIs, and p-values.|LSM difference|26.5|||<|0.001|TWO_SIDED|95.0|20.24|32.75|||Linear mixed effect model|||||32.75|20.24|<0.001
72535092|NCT03522506|144599411|SUPERIORITY|The effect of TAK-925 was evaluated with a linear mixed effects model appropriate for a 4-period crossover study. The LSM sleep latency for each treatment and the associated standard error and 95% CI was estimated from the model at each time, along with differences between active treatments and placebo, and associated standard errors, 95% CIs, and p-values.|LSM difference|14.56|||<|0.001|TWO_SIDED|95.0|7.04|22.08|||Linear mixed effect model|||||22.08|7.04|<0.001
72535093|NCT03522506|144599411|SUPERIORITY|The effect of TAK-925 was evaluated with a linear mixed effects model appropriate for a 4-period crossover study. The LSM sleep latency for each treatment and the associated standard error and 95% CI was estimated from the model at each time, along with differences between active treatments and placebo, and associated standard errors, 95% CIs, and p-values.|LSM difference|32.21|||<|0.001|TWO_SIDED|95.0|24.68|39.73|||Linear mixed effect model|||||39.73|24.68|<0.001
72535094|NCT03522506|144599411|SUPERIORITY|The effect of TAK-925 was evaluated with a linear mixed effects model appropriate for a 4-period crossover study. The LSM sleep latency for each treatment and the associated standard error and 95% CI was estimated from the model at each time, along with differences between active treatments and placebo, and associated standard errors, 95% CIs, and p-values.|LSM difference|25.74|||<|0.001|TWO_SIDED|95.0|18.33|33.14|||Linear mixed effect model|||||33.14|18.33|<0.001
72535095|NCT03522506|144599412|SUPERIORITY|The effect of TAK-925 was evaluated with a linear mixed effects model appropriate for a 4-period crossover study. The LSM sleep latency for each treatment and the associated standard error and 95% CI was estimated from the model at each time, along with differences between active treatments and placebo, and associated standard errors, 95% CIs, and p-values.|LSM difference|9.6||||0.003|TWO_SIDED|95.0|3.35|15.85|||Linear mixed effect model|||||15.85|3.35|0.003
72535096|NCT03522506|144599412|SUPERIORITY|The effect of TAK-925 was evaluated with a linear mixed effects model appropriate for a 4-period crossover study. The LSM sleep latency for each treatment and the associated standard error and 95% CI was estimated from the model at each time, along with differences between active treatments and placebo, and associated standard errors, 95% CIs, and p-values.|LSM difference|33.33|||<|0.001|TWO_SIDED|95.0|27.08|39.58|||Linear mixed effect model|||||39.58|27.08|<0.001
72535097|NCT03522506|144599412|SUPERIORITY|The effect of TAK-925 was evaluated with a linear mixed effects model appropriate for a 4-period crossover study. The LSM sleep latency for each treatment and the associated standard error and 95% CI was estimated from the model at each time, along with differences between active treatments and placebo, and associated standard errors, 95% CIs, and p-values.|LSM difference|16.91|||<|0.001|TWO_SIDED|95.0|10.77|23.06|||Linear mixed effect model|||||23.06|10.77|<0.001
72535098|NCT03522506|144599413|SUPERIORITY|An analysis of variance (ANOVA) model was used to evaluate the 1 hour post the end of infusion MWT. The LSM sleep latency for each treatment and the associated standard error and 95% CI were estimated from the model, along with the differences between active treatments and placebo, and associated standard errors, 95% CIs, and p-values.|LSM difference|-2.16||||0.436|TWO_SIDED|95.0|-7.68|3.36|||ANOVA|||||3.36|-7.68|0.436
72535099|NCT03522506|144599413|SUPERIORITY|ANOVA model was used to evaluate the 1 hour post the end of infusion MWT. The LSM sleep latency for each treatment and the associated standard error and 95% CI were estimated from the model, along with the differences between active treatments and placebo, and associated standard errors, 95% CIs, and p-values.|LSM difference|-2.29||||0.409|TWO_SIDED|95.0|-7.81|3.23|||ANOVA|||||3.23|-7.81|0.409
72572918|NCT01948986|144673000|SUPERIORITY_OR_OTHER||Ratio (Heathy Normal/T2DM Normal)|101.57|||||TWO_SIDED|90.0|78.83|130.87|||||The model was an ANOVA model with renal function group as a fixed effect. The ratios (and 90% CIs) are expressed as percentages.|||130.87|78.83|
72626573|NCT01576783|144781969|OTHER|The reported p-value is for the comparison of the scores between groups (DHA+AA vs. Placebo) at the end of the trial.||||||0.32||||||Threshold for statistical significance (\<0.05).|Mixed Models Analysis|Continuous scores at the end of the trial were compared using a linear mixed model.||||||0.32
72535100|NCT03522506|144599413|SUPERIORITY|ANOVA model was used to evaluate the 1 hour post the end of infusion MWT. The LSM sleep latency for each treatment and the associated standard error and 95% CI were estimated from the model, along with the differences between active treatments and placebo, and associated standard errors, 95% CIs, and p-values.|LSM difference|16.77|||<|0.001|TWO_SIDED|95.0|11.37|22.18|||ANOVA|||||22.18|11.37|<0.001
72535101|NCT03480243|144599414|OTHER||Cmax Estimate Ratio|1.9|||||TWO_SIDED|90.0|1.59|2.27|||ANOVA|||The analysis of variance model included the fixed effects period (1, 2 or 3b) and participant as a random effect.||2.27|1.59|
72535102|NCT03480243|144599414|OTHER||Cmax Estimate Ratio|1.81|||||TWO_SIDED|90.0|1.51|2.16|||ANOVA|||The analysis of variance model included the fixed effects period (1, 2 or 3b) and participant as a random effect.||2.16|1.51|
72535103|NCT03480243|144599415|OTHER||AUC Estimate Ratio|1.8|||||TWO_SIDED|90.0|1.5|2.17|||ANOVA|||The analysis of variance model included the fixed effects period (1, 2 or 3b) and participant as a random effect.||2.17|1.50|
72535104|NCT03480243|144599415|OTHER||AUC Estimate Ratio|1.64|||||TWO_SIDED|90.0|1.36|1.97|||ANOVA|||The analysis of variance model included the fixed effects period (1, 2 or 3b) and participant as a random effect.||1.97|1.36|
72535105|NCT03480243|144599416|OTHER||Cmax,ss Estimate Ratio|2.13|||||TWO_SIDED|90.0|1.77|2.55|||ANOVA|||The analysis of variance model included the fixed effects period (1, 2 or 3b) and participant as a random effect.||2.55|1.77|
72535106|NCT03480243|144599416|OTHER||Cmax,ss Estimate Ratio|2.13|||||TWO_SIDED|90.0|1.78|2.56|||ANOVA|||The analysis of variance model included the fixed effects period (1, 2 or 3b) and participant as a random effect.||2.56|1.78|
72535107|NCT03480243|144599417|OTHER||AUCtau Estimate Ratio|2.48|||||TWO_SIDED|90.0|2.02|3.03|||ANOVA|||The analysis of variance model included the fixed effects period (1, 2 or 3b) and participant as a random effect.||3.03|2.02|
72572919|NCT01948986|144673000|SUPERIORITY_OR_OTHER||Ratio (Mild Renal Impair./Pooled Norm.)|143.74|||||TWO_SIDED|90.0|117.15|176.37|||||The model was an ANOVA model with renal function group as a fixed effect. The ratios (and 90% CIs) are expressed as percentages.|||176.37|117.15|
72572920|NCT01948986|144673000|SUPERIORITY_OR_OTHER||Ratio (Mod. Renal Impair./Pooled Norm.)|140.37|||||TWO_SIDED|90.0|114.4|172.23|||||The model was an ANOVA model with renal function group as a fixed effect. The ratios (and 90% CIs) are expressed as percentages.|||172.23|114.40|
72572921|NCT01948986|144673000|SUPERIORITY_OR_OTHER||Ratio (Severe Renal Impair./Pooled Norm.|90.18|||||TWO_SIDED|90.0|71.99|112.96|||||The model was an ANOVA model with renal function group as a fixed effect. The ratios (and 90% CIs) are expressed as percentages.|||112.96|71.99|
72408279|NCT04304001|144324943|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|||Bivariate analyses was conducted for the knowledge scale to compare differences between the intervention and control arms. Since knowledge was a continuous variable,the values between study arms were compared using two-sample independent t-tests.||||<0.05
72408280|NCT04304001|144324944|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|||Bivariate analyses was conducted for the self-efficacy scale to compare differences between the intervention and control arms. Since self-efficacy was a continuous variable, the values between study arms were compared using two-sample independent t-tests.||||<0.05
72408281|NCT02664038|144324945|SUPERIORITY||Mean Difference (Final Values)|-2.82|STANDARD_ERROR_OF_MEAN|2.68|<|0.05|TWO_SIDED|0.05|-8.23|2.588|||ANCOVA|covaried for days of heavy drinking over the 30 days prior to randomization.||||2.588|-8.23|<.05
72408282|NCT02664038|144324946|SUPERIORITY||Mean Difference (Final Values)|0.16|STANDARD_ERROR_OF_MEAN|1.66|<|0.05|TWO_SIDED|0.05|-3.26|3.61|||ANCOVA|Days of heavy drinking 30 days prior to randomization||||3.61|-3.26|<.05
72408283|NCT02664038|144324947|SUPERIORITY||Mean Difference (Final Values)|2.94|STANDARD_ERROR_OF_MEAN|1.49||0.77|TWO_SIDED|0.05|1.45|4.43|||Mixed Models Analysis|Repeated measure with Baseline, 13 weeks and 26 weeks||||4.43|1.45|.77
72408284|NCT02664038|144324948|SUPERIORITY||Mean Difference (Final Values)|1.44|STANDARD_ERROR_OF_MEAN|1.53|<|0.05|TWO_SIDED|95.0|-1.61|4.5|||Mixed Models Analysis|||||4.50|-1.61|<.05
72408285|NCT02664038|144324949|SUPERIORITY||Mean Difference (Final Values)|0.46|STANDARD_ERROR_OF_MEAN|0.43||0.05|TWO_SIDED|0.05|0.19|1.11|||t-test, 2 sided|||||1.11|.19|.05
72572922|NCT01948986|144673007|SUPERIORITY_OR_OTHER||Ratio (Heathy Normal/T2DM Normal)|80.39|||||TWO_SIDED|90.0|59.41|108.76|||||The model was an ANOVA model with renal function group as a fixed effect. The ratios (and 90% CIs) are expressed as percentages.|||108.76|59.41|
72572923|NCT01948986|144673007|SUPERIORITY_OR_OTHER||Ratio (Mild Renal Impair./Pooled Norm.)|53.46|||||TWO_SIDED|90.0|41.64|68.63|||||The model was an ANOVA model with renal function group as a fixed effect. The ratios (and 90% CIs) are expressed as percentages.|||68.63|41.64|
72408286|NCT04456699|144324966|SUPERIORITY||Hazard Ratio (HR)|1.41||||0.9774|TWO_SIDED|95.0|1.0|1.97|||Log Rank|One-sided p-value based on log-rank test stratified by prior FOLFOX/CAPOX + Bev induction response, number of induction cycles and mutation status.|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by prior FOLFOX/CAPOX + Bev induction response, number of induction cycles and mutation status.|||1.97|1.00|0.9774
72572924|NCT01948986|144673007|SUPERIORITY_OR_OTHER||Ratio (Mod. Renal Impair./Pooled Norm.)|43.45|||||TWO_SIDED|90.0|33.85|55.78|||||The model was an ANOVA model with renal function group as a fixed effect. The ratios (and 90% CIs) are expressed as percentages.|||55.78|33.85|
72408287|NCT04456699|144324966|SUPERIORITY||Hazard Ratio (HR)|1.75||||0.9993|TWO_SIDED|95.0|1.23|2.49|||Log Rank|One-sided p-value based on log-rank test stratified by prior FOLFOX/CAPOX + Bev induction response, number of induction cycles and mutation status.|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by prior FOLFOX/CAPOX + Bev induction response, number of induction cycles and mutation status.|||2.49|1.23|0.9993
72408288|NCT04456699|144324967|SUPERIORITY||Hazard Ratio (HR)|0.81||||0.1527|TWO_SIDED|95.0|0.54|1.21|||Log Rank|One-sided p-value based on log-rank test stratified by prior FOLFOX/CAPOX + Bev induction response, number of induction cycles and mutation status.|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by prior FOLFOX/CAPOX + Bev induction response, number of induction cycles and mutation status.|||1.21|0.54|0.1527
72408289|NCT04456699|144324967|SUPERIORITY||Hazard Ratio (HR)|0.87||||0.2491|TWO_SIDED|95.0|0.59|1.3|||Log Rank|One-sided p-value based on log-rank test stratified by prior FOLFOX/CAPOX + Bev induction response, number of induction cycles and mutation status.|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by prior FOLFOX/CAPOX + Bev induction response, number of induction cycles and mutation status.|||1.30|0.59|0.2491
72408290|NCT04456699|144324968|SUPERIORITY||Difference in Percentage|-0.2||||0.5272|TWO_SIDED|95.0|-7.0|6.5|||Miettinen and Nurminen|Based on stratified Miettinen \& Nurminen method. One-sided p-value for testing H0: difference in % = 0 versus H1: difference in % \> 0.|Based on Miettinen \& Nurminen method stratified by prior FOLFOX/CAPOX + Bev induction response, cycles and mutation status.|||6.5|-7.0|0.5272
72408291|NCT04456699|144324968|SUPERIORITY||Difference in Percentage|-3.2||||0.902|TWO_SIDED|95.0|-9.7|2.3|||Miettinen & Nurminen|Based on stratified Miettinen \& Nurminen method. One-sided p-value for testing H0: difference in % = 0 versus H1: difference in % \> 0.|Based on Miettinen \& Nurminen method stratified by prior FOLFOX/CAPOX + Bev induction response, cycles and mutation status.|||2.3|-9.7|0.9020
72408292|NCT02915029|144324979|SUPERIORITY|The primary hypothesis being tested was that the intervention will increase patient activation.|Mean Difference (Net)|8.7||||0.01|TWO_SIDED|95.0|1.9|15.5|||ANCOVA|Primary outcome was change in PAM total score, adjusted for baseline level. Adjusting for family clustering with generalized estimated equations.|This reflects the between-group difference for the within-person change scores in PAM total score adjusting for baseline values per person.|Group 1(usual care) is the comparison group, group 2 is the intervention group.|Applied generalized estimating equations (GEE) to account for within family (household) clustering.|15.5|1.9|0.01
72572925|NCT01948986|144673007|SUPERIORITY_OR_OTHER||Ratio (Severe Renal Impair./Pooled Norm.|29.02|||||TWO_SIDED|90.0|22.04|38.21|||||The model was an ANOVA model with renal function group as a fixed effect. The ratios (and 90% CIs) are expressed as percentages.|||38.21|22.04|
72572926|NCT01948986|144673024|SUPERIORITY_OR_OTHER||Ratio: Mild Ren. Impa./T2DM Norm. Renal|76.73|||||TWO_SIDED|95.0|48.58|121.19|||||Adjusted geometrics mean values were used. The model was an ANOVA model with renal function group as a fixed effect.|||121.19|48.58|
72572927|NCT01948986|144673024|SUPERIORITY_OR_OTHER||Ratio: Mod. Ren. Impa./T2DM Norm. Renal|86.52|||||TWO_SIDED|95.0|54.78|136.65|||||Adjusted geometrics mean values were used. The model was an ANOVA model with renal function group as a fixed effect.|||136.65|54.78|
72572928|NCT01948986|144673024|SUPERIORITY_OR_OTHER||Ratio: Sev. Ren. Impa./T2DM Norm. Renal|72.74|||||TWO_SIDED|95.0|44.63|118.58|||||Adjusted geometrics mean values were used. The model was an ANOVA model with renal function group as a fixed effect.|||118.58|44.63|
72572929|NCT01948986|144673026|SUPERIORITY_OR_OTHER||Ratio (Mild Renal Impair./T2DM Norm. Ren|49.75|||||TWO_SIDED|90.0|27.22|90.93|||||The model was an ANOVA model with renal function group as a fixed effect.|||90.93|27.22|
72535108|NCT03480243|144599417|OTHER||AUCtau Estimate Ratio|2.23|||||TWO_SIDED|90.0|1.82|2.73|||ANOVA|||The analysis of variance model included the fixed effects period (1, 2 or 3b) and participant as a random effect.||2.73|1.82|
72535109|NCT00761085|144599442|OTHER|No statistical comparisons||||||||||||||||"No statistical comparisons of methadone concentration in patients receiving methadone vs not receiving methadone (children or adults).~No statistical comparisons of methadone concentration in children vs adults"|No statistical comparisons|||
72535110|NCT00761085|144599443|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<0.05
72535111|NCT01522755|144599446|OTHER|t-test|||||<|0.05|||||||t-test, 2 sided|||||||<0.05
72535112|NCT01522755|144599447|OTHER|t-test|||||<|0.05|||||||t-test, 2 sided|||||||<0.05
72535113|NCT01522755|144599448|OTHER|t-test|||||<|0.05|||||||t-test, 2 sided|||||||<0.05
72535114|NCT03414658|144599449|SUPERIORITY||Hazard Ratio (HR)|0.53||||0.025|TWO_SIDED|80.0|0.35|0.81|||Log Rank|||||0.81|0.35|0.025
72535115|NCT03414658|144599449|SUPERIORITY||Hazard Ratio (HR)|1.14||||0.32|TWO_SIDED|80.0|0.8|1.64|||Log Rank|||||1.64|0.8|0.32
72535116|NCT02388906|144599453|SUPERIORITY||Hazard Ratio (HR)|0.71||||0.0003|TWO_SIDED|95.0|0.6|0.86|||Log Rank|Stratified log rank||||0.86|0.60|0.0003
72535117|NCT02388906|144599454|SUPERIORITY||Hazard Ratio (HR)|0.88|||||TWO_SIDED|95.03|0.69|1.11|||Log Rank||Stratified Cox proportional hazard model|||1.11|0.69|
72535118|NCT02388906|144599461|SUPERIORITY||Hazard Ratio (HR)|0.76|||||TWO_SIDED|95.0|0.63|0.9|||Log Rank|Stratified log rank||||0.90|0.63|
72535119|NCT04365387|144599462|OTHER||Cochran-Mantel-Haenszel|2.1|||||TWO_SIDED|90.0|-10.3|14.5|||||Risk Difference (90% CI) were estimated using weighted average of stratum-specific proportion using Cochran-Mantel-Haenszel (CMH).|||14.5|-10.3|
72535120|NCT04365387|144599463|OTHER||Cochran-Mantel-Haenszel|-4.6|||||TWO_SIDED|90.0|-14.9|5.7|||||Risk Difference (90% CI) were estimated using weighted average of stratum-specific proportion using CMH.|||5.7|-14.9|
72535121|NCT04365387|144599465|OTHER||Cochran-Mantel-Haenszel|1.4|||||TWO_SIDED|90.0|-3.2|5.9|||||Risk Difference (90% CI) were estimated using weighted average of stratum-specific proportion using CMH.|||5.9|-3.2|
72535122|NCT04365387|144599466|OTHER||Cochran-Mantel-Haenszel|13.3|||||TWO_SIDED|90.0|0.1|26.4|||||Risk Difference (90% CI) were estimated using weighted average of stratum-specific proportion using CMH for non-Imputed values|||26.4|0.1|
72535123|NCT04365387|144599467|OTHER||Cochran-Mantel-Haenszel|1.3|||||TWO_SIDED|90.0|-9.3|11.9|||||Risk Difference (90% CI) were estimated using weighted average of stratum-specific proportion using CMH.|||11.9|-9.3|
72535124|NCT05770401|144599469|SUPERIORITY||Mean Difference (Final Values)|3.24|STANDARD_ERROR_OF_MEAN|1.227||0.014|TWO_SIDED|95.0|0.72|5.76|||ANCOVA|||The null hypothesis was there would be no significant difference in LCQ total score change from baseline to one-week post-treatment between groups.||5.76|.72|.014
72535125|NCT05770401|144599470|SUPERIORITY||Mean Difference (Final Values)|-16.1|STANDARD_ERROR_OF_MEAN|8.804||0.056|TWO_SIDED|95.0|-32.7|0.46|||ANCOVA|||The null hypothesis was there would be no significant difference in Cough Severity VAS Scores from baseline to one-week post-treatment between groups.||0.46|-32.7|.056
72535126|NCT04957979|144599516|SUPERIORITY||Mean Difference (Net)|-1.6||||0.19|TWO_SIDED|95.0|-4.1|0.1||No adjustments for multiple comparisons. Two-sided alpha of 0.05 specified a-priori|Mixed Models Analysis|Adjusted for patient demographics, comorbidities, clinic characteristics, and includes random effect for clustering within clinic.|Negative value represents smaller change in Medical/Social clinics as compared to Medical/Nursing.|Null hypothesis: Average change in composite care quality outcome is not different between patients receiving care in Medical/Nursing Model clinics and those receiving care in Medical/Social Model clinics.||0.1|-4.1|0.19
72535127|NCT04957979|144599516|SUPERIORITY||Mean Difference (Net)|-3.3||||0.005|TWO_SIDED|95.0|-5.6|-1.0||No adjustments for multiple comparisons. Two-sided alpha of 0.05 specified a-priori|Mixed Models Analysis|Adjusted for patient demographics, comorbidities, clinic characteristics, and includes random effect for clustering within clinic.|Negative value represents smaller change in Medical/Social clinics as compared to Medical/Nursing.|Null hypothesis: Average change in composite care quality outcome is not different between patients receiving care in Medical/Nursing Model clinics and those receiving care in Medical/Social Model clinics.||-1.0|-5.6|0.005
72535128|NCT04957979|144599517|SUPERIORITY||Incidence Rate Ratio|1.28||||0.02|TWO_SIDED|95.0|1.04|1.58||No adjustments for multiple comparisons. Two-sided alpha of 0.05 specified a-priori|Mixed Models Analysis|Adjusted for patient demographics, comorbidities, clinic characteristics, and includes random effect for clustering within clinic.|Values \> 1.0 represents higher rates post-care coordination in Medical/Social clinics as compared to Medical/Nursing.|Generalized Linear Mixed Models with Poisson link function. Pre-care coordination measures were included as an independent variable when modeling post-measures to capture change related to care coordination initiation.||1.58|1.04|0.02
72535129|NCT04957979|144599517|SUPERIORITY||Incidence Rate Ratio|1.09||||0.45|TWO_SIDED|95.0|0.868|1.38||No adjustments for multiple comparisons. Two-sided alpha of 0.05 specified a-priori|Mixed Models Analysis|Adjusted for patient demographics, comorbidities, clinic characteristics, and includes random effect for clustering within clinic.|Values \> 1.0 represents higher rates post-care coordination in Medical/Social clinics as compared to Medical/Nursing.|Generalized Linear Mixed Models with Poisson link function. Pre-care coordination measures were included as an independent variable when modeling post-measures to capture change related to care coordination initiation.||1.38|0.868|0.45
72535130|NCT04957979|144599518|SUPERIORITY||Incidence Rate Ratio|1.35||||0.01|TWO_SIDED|95.0|1.08|1.69||No adjustments for multiple comparisons. Two-sided alpha of 0.05 specified a-priori|Mixed Models Analysis|Adjusted for patient demographics, comorbidities, clinic characteristics, and includes random effect for clustering within clinic.|Values \> 1.0 represents higher rates post-care coordination in Medical/Social clinics as compared to Medical/Nursing.|Generalized Linear Mixed Models with Poisson link function. Pre-care coordination measures were included as an independent variable when modeling post-measures to capture change related to care coordination initiation.||1.69|1.08|0.01
72572930|NCT01948986|144673026|SUPERIORITY_OR_OTHER||Ratio (Mod. Renal Impair./T2DM Norm. Ren|38.1|||||TWO_SIDED|90.0|20.85|69.64|||||The model was an ANOVA model with renal function group as a fixed effect.|||69.64|20.85|
72572931|NCT01948986|144673026|SUPERIORITY_OR_OTHER||Ratio (Sev. Renal Impair./T2DM Norm. Ren|13.95|||||TWO_SIDED|90.0|7.32|26.58|||||The model was an ANOVA model with renal function group as a fixed effect.|||26.58|7.32|
72572932|NCT00536263|144673027|SUPERIORITY_OR_OTHER||Pairwise rate difference|0.008||||0.86|TWO_SIDED|95.0|-0.063|0.079||P-values are unadjusted; Hochberg's adjustment for multiple comparisons was used to maintain the overall 0.05 significance level in test of superiority using the Cochran-Mantel-Haenszel test.|Cochran-Mantel-Haenszel|Stratified by genotype||"Null hypothesis: no difference in the proportion with HBeAg loss.~Based on the targeted sample size, there was 80% statistical power (2-sided 0.05 alpha) to detect a true 36% HBeAg loss rate in this treatment arm versus a true rate of 23% in the control arm."||0.079|-0.063|0.860
72576779|NCT00261443|144680651|SUPERIORITY_OR_OTHER_LEGACY||Difference|-1.1||||0.047|TWO_SIDED|95.0|-2.19|-0.01||Mean change from baseline: ANOVA model, controlling for treatment, mood stabilizer, index mood episode, and baseline value. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 12 Comparison||-0.01|-2.19|0.047
72535131|NCT04957979|144599518|SUPERIORITY||Incidence Rate Ratio|1.33||||0.08|TWO_SIDED|95.0|0.969|1.81||No adjustments for multiple comparisons. Two-sided alpha of 0.05 specified a-priori|Mixed Models Analysis|Adjusted for patient demographics, comorbidities, clinic characteristics, and includes random effect for clustering within clinic.|Values \> 1.0 represents higher rates post-care coordination in Medical/Social clinics as compared to Medical/Nursing.|Generalized Linear Mixed Models with Poisson link function. Pre-care coordination measures were included as an independent variable when modeling post-measures to capture change related to care coordination initiation.||1.81|0.969|0.08
72535132|NCT04957979|144599519|SUPERIORITY||Odds Ratio (OR)|0.64||||0.0001|TWO_SIDED|95.0|0.51|0.81||No adjustments for multiple comparisons. Two-sided alpha of 0.05 specified a-priori|Mixed Models Analysis|Adjusted for patient demographics, comorbidities, clinic characteristics, and includes random effect for clustering within clinic.|Values \> 1.0 represents higher likelihood of positive rating in Medical/Social clinics as compared to Medical/Nursing.|Generalized Linear Mixed Models with Binomial link function.||0.81|0.51|0.0001
72535133|NCT04957979|144599519|SUPERIORITY||Odds Ratio (OR)|1.2||||0.32|TWO_SIDED|95.0|0.84|1.72||No adjustments for multiple comparisons. Two-sided alpha of 0.05 specified a-priori|Mixed Models Analysis|Adjusted for patient demographics, comorbidities, clinic characteristics, and includes random effect for clustering within clinic.|Values \> 1.0 represents higher likelihood of positive rating in Medical/Social clinics as compared to Medical/Nursing.|Generalized Linear Mixed Models with Binomial link function.||1.72|0.84|0.32
72535134|NCT04957979|144599520|SUPERIORITY||Odds Ratio (OR)|0.85||||0.14|TWO_SIDED|95.0|0.69|1.05||No adjustments for multiple comparisons. Two-sided alpha of 0.05 specified a-priori|Mixed Models Analysis|Adjusted for patient demographics, comorbidities, clinic characteristics, and includes random effect for clustering within clinic.|Values \> 1.0 represents higher likelihood of positive rating in Medical/Social clinics as compared to Medical/Nursing.|Generalized Linear Mixed Models with Binomial link function.||1.05|0.69|0.14
72535135|NCT04957979|144599520|SUPERIORITY||Odds Ratio (OR)|0.74||||0.12|TWO_SIDED|95.0|0.51|1.08||No adjustments for multiple comparisons. Two-sided alpha of 0.05 specified a-priori|Mixed Models Analysis|Adjusted for patient demographics, comorbidities, clinic characteristics, and includes random effect for clustering within clinic.|Values \> 1.0 represents higher likelihood of positive rating in Medical/Social clinics as compared to Medical/Nursing.|Generalized Linear Mixed Models with Binomial link function.||1.08|0.51|0.12
72535136|NCT04957979|144599521|SUPERIORITY||Odds Ratio (OR)|1.086||||0.914|TWO_SIDED|95.0|0.243|4.861||No adjustments for multiple comparisons. Two-sided alpha of 0.05 specified a-priori|Mixed Models Analysis|Binomial link function. Estimation parameter is the interaction between Time (post vs pre) and Care Model (Medical/Social vs Medical Nursing).|Values \> 1.0 represents larger improvement pre to post-care coordination in likelihood of specific care quality outcome for patients in Medical/Social clinics as compared to those in Medical/Nursing.|||4.861|0.243|0.914
72535137|NCT04957979|144599521|SUPERIORITY||Odds Ratio (OR)|1.009||||0.987|TWO_SIDED|95.0|0.327|3.114||No adjustments for multiple comparisons. Two-sided alpha of 0.05 specified a-priori|Mixed Models Analysis|Binomial link function. Estimation parameter is the interaction between Time (post vs pre) and Care Model (Medical/Social vs Medical Nursing).|Values \> 1.0 represents larger improvement pre to post-care coordination in likelihood of specific care quality outcome for patients in Medical/Social clinics as compared to those in Medical/Nursing.|||3.114|0.327|0.987
72535138|NCT04957979|144599522|SUPERIORITY||Odds Ratio (OR)|1.257||||0.204|TWO_SIDED|95.0|0.883|1.79||No adjustments for multiple comparisons. Two-sided alpha of 0.05 specified a-priori|Mixed Models Analysis|Binomial link function. Estimation parameter is the interaction between Time (post vs pre) and Care Model (Medical/Social vs Medical Nursing).|Values \> 1.0 represents larger improvement pre to post-care coordination in likelihood of specific care quality outcome for patients in Medical/Social clinics as compared to those in Medical/Nursing.|||1.79|0.883|0.204
72535139|NCT04957979|144599522|SUPERIORITY||Odds Ratio (OR)|0.399||||0.04|TWO_SIDED|95.0|0.166|0.958|||Mixed Models Analysis|||||0.958|0.166|0.04
72535140|NCT04957979|144599523|SUPERIORITY||Odds Ratio (OR)|1.257||||0.302|TWO_SIDED|95.0|0.814|1.939||No adjustments for multiple comparisons. Two-sided alpha of 0.05 specified a-priori|Mixed Models Analysis|Binomial link function. Estimation parameter is the interaction between Time (post vs pre) and Care Model (Medical/Social vs Medical Nursing).|Values \> 1.0 represents larger improvement pre to post-care coordination in likelihood of specific care quality outcome for patients in Medical/Social clinics as compared to those in Medical/Nursing.|||1.939|0.814|0.302
72535141|NCT04957979|144599523|SUPERIORITY||Odds Ratio (OR)|0.84||||0.192|TWO_SIDED|95.0|0.647|1.092||No adjustments for multiple comparisons. Two-sided alpha of 0.05 specified a-priori|Mixed Models Analysis|Binomial link function. Estimation parameter is the interaction between Time (post vs pre) and Care Model (Medical/Social vs Medical Nursing).|Values \> 1.0 represents larger improvement pre to post-care coordination in likelihood of specific care quality outcome for patients in Medical/Social clinics as compared to those in Medical/Nursing.|||1.092|0.647|0.192
72626574|NCT01576783|144781969|OTHER|The reported p-value is for the comparison of the scores between groups (DHA+AA vs. Placebo) at the end of the trial.||||||0.97||||||Threshold for statistical significance (\<0.05).|Mixed Models Analysis|Continuous scores at the end of the trial were compared using a linear mixed model.||||||0.97
72626575|NCT01576783|144781969|OTHER|The reported p-value is for the comparison of the scores between groups (DHA+AA vs. Placebo) at the end of the trial.||||||0.62||||||Threshold for statistical significance (\<0.05).|Mixed Models Analysis|Continuous scores at the end of the trial were compared using a linear mixed model.||||||0.62
72626576|NCT01576783|144781969|OTHER|The reported p-value is for the comparison of the scores between groups (DHA+AA vs. Placebo) at the end of the trial.||||||0.69||||||Threshold for statistical significance (\<0.05).|Mixed Models Analysis|Continuous scores at the end of the trial were compared using a linear mixed model.||||||0.69
72408293|NCT00086580|144324999|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.61|||<|0.001|TWO_SIDED|95.0|0.467|0.795|||Regression, Cox|Cox proportional hazards model was stratified by Rai Stage Group||||0.795|0.467|<0.001
72535142|NCT04957979|144599524|SUPERIORITY||Odds Ratio (OR)|0.438||||0.318|TWO_SIDED|95.0|0.086|2.22||No adjustments for multiple comparisons. Two-sided alpha of 0.05 specified a-priori|Mixed Models Analysis|Binomial link function. Estimation parameter is the interaction between Time (post vs pre) and Care Model (Medical/Social vs Medical Nursing).|Values \> 1.0 represents larger improvement pre to post-care coordination in likelihood of specific care quality outcome for patients in Medical/Social clinics as compared to those in Medical/Nursing.|||2.22|0.086|0.318
72535143|NCT04957979|144599524|SUPERIORITY||Odds Ratio (OR)|1.793||||0.421|TWO_SIDED|95.0|0.433|7.426||No adjustments for multiple comparisons. Two-sided alpha of 0.05 specified a-priori|Mixed Models Analysis|Binomial link function. Estimation parameter is the interaction between Time (post vs pre) and Care Model (Medical/Social vs Medical Nursing).|Values \> 1.0 represents larger improvement pre to post-care coordination in likelihood of specific care quality outcome for patients in Medical/Social clinics as compared to those in Medical/Nursing.|||7.426|0.433|0.421
72535144|NCT04957979|144599525|SUPERIORITY||Odds Ratio (OR)|0.906||||0.632|TWO_SIDED|95.0|0.606|1.356||No adjustments for multiple comparisons. Two-sided alpha of 0.05 specified a-priori|Mixed Models Analysis|Binomial link function. Estimation parameter is the interaction between Time (post vs pre) and Care Model (Medical/Social vs Medical Nursing).|Values \> 1.0 represents larger improvement pre to post-care coordination in likelihood of specific care quality outcome for patients in Medical/Social clinics as compared to those in Medical/Nursing.|||1.356|0.606|0.632
72535145|NCT04957979|144599525|SUPERIORITY||Odds Ratio (OR)|0.845||||0.492|TWO_SIDED|95.0|0.523|1.366||No adjustments for multiple comparisons. Two-sided alpha of 0.05 specified a-priori|Mixed Models Analysis|Binomial link function. Estimation parameter is the interaction between Time (post vs pre) and Care Model (Medical/Social vs Medical Nursing).|Values \> 1.0 represents larger improvement pre to post-care coordination in likelihood of specific care quality outcome for patients in Medical/Social clinics as compared to those in Medical/Nursing.|||1.366|0.523|0.492
72535146|NCT04957979|144599526|SUPERIORITY||Odds Ratio (OR)|0.856||||0.405|TWO_SIDED|95.0|0.594|1.234||No adjustments for multiple comparisons. Two-sided alpha of 0.05 specified a-priori|Mixed Models Analysis|Binomial link function. Estimation parameter is the interaction between Time (post vs pre) and Care Model (Medical/Social vs Medical Nursing).|Values \> 1.0 represents larger improvement pre to post-care coordination in likelihood of specific care quality outcome for patients in Medical/Social clinics as compared to those in Medical/Nursing.|||1.234|0.594|0.405
72535147|NCT04957979|144599526|SUPERIORITY||Odds Ratio (OR)|0.559||||0.004|TWO_SIDED|95.0|0.374|0.834|||Mixed Models Analysis|||||0.834|0.374|0.004
72535148|NCT04957979|144599527|SUPERIORITY||Odds Ratio (OR)|0.151||||0.071|TWO_SIDED|95.0|0.02|1.173||No adjustments for multiple comparisons. Two-sided alpha of 0.05 specified a-priori|Mixed Models Analysis|Binomial link function. Estimation parameter is the interaction between Time (post vs pre) and Care Model (Medical/Social vs Medical Nursing).|Values \> 1.0 represents larger improvement pre to post-care coordination in likelihood of specific care quality outcome for patients in Medical/Social clinics as compared to those in Medical/Nursing.|||1.173|0.02|0.071
72535149|NCT04957979|144599527|SUPERIORITY||Mean Difference (Net)|0.023||||0.003|TWO_SIDED|95.0|0.002|0.268||No adjustments for multiple comparisons. Two-sided alpha of 0.05 specified a-priori|Mixed Models Analysis|Binomial link function. Estimation parameter is the interaction between Time (post vs pre) and Care Model (Medical/Social vs Medical Nursing).|Values \> 1.0 represents larger improvement pre to post-care coordination in likelihood of specific care quality outcome for patients in Medical/Social clinics as compared to those in Medical/Nursing.|||0.268|0.002|0.003
72535150|NCT04957979|144599528|SUPERIORITY||Odds Ratio (OR)|0.884||||0.557|TWO_SIDED|95.0|0.587|1.333||No adjustments for multiple comparisons. Two-sided alpha of 0.05 specified a-priori|Mixed Models Analysis|Binomial link function. Estimation parameter is the interaction between Time (post vs pre) and Care Model (Medical/Social vs Medical Nursing).|Values \> 1.0 represents larger improvement pre to post-care coordination in likelihood of specific care quality outcome for patients in Medical/Social clinics as compared to those in Medical/Nursing.|||1.333|0.587|0.557
72535151|NCT04957979|144599528|SUPERIORITY||Mean Difference (Net)|0.624||||0.069|TWO_SIDED|95.0|0.376|1.037||No adjustments for multiple comparisons. Two-sided alpha of 0.05 specified a-priori|Mixed Models Analysis|Binomial link function. Estimation parameter is the interaction between Time (post vs pre) and Care Model (Medical/Social vs Medical Nursing).|Values \> 1.0 represents larger improvement pre to post-care coordination in likelihood of specific care quality outcome for patients in Medical/Social clinics as compared to those in Medical/Nursing.|||1.037|0.376|0.069
72535152|NCT04957979|144599529|SUPERIORITY||Odds Ratio (OR)|0.539||||0.256|TWO_SIDED|95.0|0.185|1.565||No adjustments for multiple comparisons. Two-sided alpha of 0.05 specified a-priori|Mixed Models Analysis|Binomial link function. Estimation parameter is the interaction between Time (post vs pre) and Care Model (Medical/Social vs Medical Nursing).|Values \> 1.0 represents larger improvement pre to post-care coordination in likelihood of specific care quality outcome for patients in Medical/Social clinics as compared to those in Medical/Nursing.|||1.565|0.185|0.256
72535153|NCT04957979|144599529|SUPERIORITY||Odds Ratio (OR)|1.117||||0.866|TWO_SIDED|95.0|0.308|4.047||No adjustments for multiple comparisons. Two-sided alpha of 0.05 specified a-priori|Mixed Models Analysis|Binomial link function. Estimation parameter is the interaction between Time (post vs pre) and Care Model (Medical/Social vs Medical Nursing).|Values \> 1.0 represents larger improvement pre to post-care coordination in likelihood of specific care quality outcome for patients in Medical/Social clinics as compared to those in Medical/Nursing.|||4.047|0.308|0.866
72535154|NCT04957979|144599530|SUPERIORITY||Odds Ratio (OR)|0.797||||0.641|TWO_SIDED|95.0|0.307|2.069||No adjustments for multiple comparisons. Two-sided alpha of 0.05 specified a-priori|Mixed Models Analysis|Binomial link function. Estimation parameter is the interaction between Time (post vs pre) and Care Model (Medical/Social vs Medical Nursing).|Values \> 1.0 represents larger improvement pre to post-care coordination in likelihood of specific care quality outcome for patients in Medical/Social clinics as compared to those in Medical/Nursing.|||2.069|0.307|0.641
72535155|NCT04957979|144599530|SUPERIORITY||Odds Ratio (OR)|0.569||||0.32|TWO_SIDED|95.0|0.187|1.729||No adjustments for multiple comparisons. Two-sided alpha of 0.05 specified a-priori|Mixed Models Analysis|Binomial link function. Estimation parameter is the interaction between Time (post vs pre) and Care Model (Medical/Social vs Medical Nursing).|Values \> 1.0 represents larger improvement pre to post-care coordination in likelihood of specific care quality outcome for patients in Medical/Social clinics as compared to those in Medical/Nursing.|||1.729|0.187|0.32
72535156|NCT04957979|144599531|SUPERIORITY||Risk Difference (RD)|9.3|||<|0.001|TWO_SIDED|95.0|5.6|13.0||No adjustments for multiple comparisons. Two-sided alpha of 0.05 specified a-priori|Chi-squared||Positive values reflect higher percentage of responders in Medical/Nursing clinics as compared to Medical/Social.|||13|5.6|<.001
72535157|NCT04957979|144599531|SUPERIORITY||Risk Difference (RD)|11.0||||0.002|TWO_SIDED|95.0|4.2|18.0||No adjustments for multiple comparisons. Two-sided alpha of 0.05 specified a-priori|Chi-squared||Positive values reflect higher proportion of responders in Medical/Nursing clinics as compared to Medical/Social.|||18|4.2|0.002
72535158|NCT04957979|144599532|SUPERIORITY||Risk Difference (RD)|6.0||||0.023|TWO_SIDED|95.0|0.86|11.0||No adjustments for multiple comparisons. Two-sided alpha of 0.05 specified a-priori|Chi-squared||Positive values reflect higher percentage of responders in Medical/Nursing clinics as compared to Medical/Social.|||11.0|0.86|0.023
72535159|NCT04957979|144599532|SUPERIORITY||Risk Difference (RD)|-3.7||||0.5|TWO_SIDED|95.0|-14.0|7.0||No adjustments for multiple comparisons. Two-sided alpha of 0.05 specified a-priori|Chi-squared||Positive values reflect higher proportion of responders in Medical/Nursing clinics as compared to Medical/Social.|||7.0|-14.0|0.5
72535160|NCT04957979|144599533|SUPERIORITY||Mean Difference (Net)|0.13|||<|0.001|TWO_SIDED|95.0|0.06|0.19||No adjustments for multiple comparisons. Two-sided alpha of 0.05 specified a-priori|t-test, 2 sided||Positive values reflect higher/better scores of responders in Medical/Nursing clinics as compared to Medical/Social.|||0.19|0.06|<0.001
72535161|NCT04957979|144599533|SUPERIORITY||Mean Difference (Net)|0.19|||<|0.001|TWO_SIDED|95.0|0.06|0.32||No adjustments for multiple comparisons. Two-sided alpha of 0.05 specified a-priori|t-test, 2 sided||Positive values reflect higher/better scores of responders in Medical/Nursing clinics as compared to Medical/Social.|||0.32|0.06|<0.001
72535162|NCT04957979|144599534|SUPERIORITY||Mean Difference (Net)|-0.11|||<|0.001|TWO_SIDED|95.0|-0.16|-0.06|||t-test, 2 sided|No adjustments for multiple comparisons. Two-sided alpha of 0.05 specified a-priori|Negative values reflect lower/better scores of responders in Medical/Nursing clinics as compared to Medical/Social.|||-0.06|-0.16|<0.001
72535163|NCT04957979|144599534|SUPERIORITY||Mean Difference (Net)|-0.11||||0.006|TWO_SIDED|95.0|-0.2|-0.03|||t-test, 2 sided||Negative values reflect lower/better scores of responders in Medical/Nursing clinics as compared to Medical/Social.|||-0.03|-0.2|0.006
72535164|NCT04957979|144599535|SUPERIORITY||Risk Difference (RD)|-2.4||||0.059|TWO_SIDED|95.0|-4.9|0.0||No adjustments for multiple comparisons. Two-sided alpha of 0.05 specified a-priori|Chi-squared|||||0.00|-4.9|0.059
72535165|NCT04957979|144599535|SUPERIORITY||Risk Difference (RD)|-5.7||||0.014|TWO_SIDED|95.0|-10.0|-1.3||No adjustments for multiple comparisons. Two-sided alpha of 0.05 specified a-priori|Chi-squared||Positive values reflect higher percentage of responders in Medical/Nursing clinics as compared to Medical/Social.|||-1.3|-10.0|0.014
72535166|NCT04957979|144599536|SUPERIORITY||Risk Difference (RD)|11.0|||<|0.001|TWO_SIDED|95.0|6.8|15.0||No adjustments for multiple comparisons. Two-sided alpha of 0.05 specified a-priori|Chi-squared|||||15.0|6.8|<0.001
72535167|NCT04957979|144599536|SUPERIORITY||Risk Difference (RD)|12.0||||0.001|TWO_SIDED|95.0|4.7|20.0||No adjustments for multiple comparisons. Two-sided alpha of 0.05 specified a-priori|Chi-squared||Positive values reflect higher percentage of responders in Medical/Nursing clinics as compared to Medical/Social.|||20.0|4.7|0.001
72535168|NCT04957979|144599537|SUPERIORITY||Mean Difference (Net)|-7.6|||<|0.001|TWO_SIDED|95.0|-10.0|-5.0||No adjustments for multiple comparisons. Two-sided alpha of 0.05 specified a-priori|t-test, 2 sided||Negative values reflect lower/better scores of responders in Medical/Nursing clinics as compared to Medical/Social.|||-5|-10|<.001
72535169|NCT04957979|144599537|SUPERIORITY||Mean Difference (Net)|-6.0||||0.007|TWO_SIDED|95.0|-10.0|-2.0|||t-test, 2 sided||Negative values reflect lower/better scores of responders in Medical/Nursing clinics as compared to Medical/Social.|||-2|-10|0.007
72535170|NCT04957979|144599538|SUPERIORITY||Risk Difference (RD)|-2.5||||0.046|TWO_SIDED|95.0|-4.8|-0.14||No adjustments for multiple comparisons. Two-sided alpha of 0.05 specified a-priori|Chi-squared||Positive values reflect higher percentage of responders in Medical/Nursing clinics as compared to Medical/Social.|||-0.14|-4.8|0.046
72535171|NCT04957979|144599538|SUPERIORITY||Risk Difference (RD)|-4.5||||0.033|TWO_SIDED|95.0|-8.4|-0.52||No adjustments for multiple comparisons. Two-sided alpha of 0.05 specified a-priori|Chi-squared||Positive values reflect higher percentage of responders in Medical/Nursing clinics as compared to Medical/Social.|||-0.52|-8.4|0.033
72535172|NCT04957979|144599539|SUPERIORITY||Risk Difference (RD)|-10.0|||<|0.001|TWO_SIDED|95.0|-13.0|-6.8||No adjustments for multiple comparisons. Two-sided alpha of 0.05 specified a-priori|Chi-squared||Positive values reflect higher percentage of responders in Medical/Nursing clinics as compared to Medical/Social.|||-6.8|-13.0|<0.001
72535173|NCT04957979|144599539|SUPERIORITY||Risk Difference (RD)|-11.0|||<|0.001|TWO_SIDED|95.0|-17.0|-5.6||No adjustments for multiple comparisons. Two-sided alpha of 0.05 specified a-priori|Chi-squared||Positive values reflect higher percentage of responders in Medical/Nursing clinics as compared to Medical/Social.|||-5.6|-17.0|<0.001
72408294|NCT00086580|144325000|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.06||||0.178|TWO_SIDED|95.0|-0.03|0.15||P-value presented is adjusted for multiple tests using Hochberg procedure for 3 clinically important secondary endpoints: ORR, CR rates and OS.|Cochran-Mantel-Haenszel|CMH chi-square test for a difference in overall response rates between treatments stratified by Rai Stage Group.|Difference and confidence interval (CI) calculated using the recommended method by Altman et al.|Comparison of Overall Response.||0.15|-0.03|0.178
72535174|NCT04957979|144599540|SUPERIORITY||Risk Difference (RD)|-7.2|||<|0.001|TWO_SIDED|95.0|-10.0|-4.1||No adjustments for multiple comparisons. Two-sided alpha of 0.05 specified a-priori|Chi-squared||Positive values reflect higher percentage of responders in Medical/Nursing clinics as compared to Medical/Social.|||-4.1|-10.0|<0.001
72535175|NCT04957979|144599540|SUPERIORITY||Risk Difference (RD)|-8.2||||0.002|TWO_SIDED|95.0|-13.0|-3.2||No adjustments for multiple comparisons. Two-sided alpha of 0.05 specified a-priori|Chi-squared||Positive values reflect higher percentage of responders in Medical/Nursing clinics as compared to Medical/Social|||-3.2|-13.0|0.002
72535176|NCT04957979|144599541|SUPERIORITY||Risk Difference (RD)|-3.4||||0.002|TWO_SIDED|95.0|-5.5|-1.4||No adjustments for multiple comparisons. Two-sided alpha of 0.05 specified a-priori|Chi-squared||Positive values reflect higher percentage of responders in Medical/Nursing clinics as compared to Medical/Social.|||-1.4|-5.5|0.002
72535177|NCT04957979|144599541|SUPERIORITY||Risk Difference (RD)|-2.4||||0.3|TWO_SIDED|95.0|-6.1|1.4||No adjustments for multiple comparisons. Two-sided alpha of 0.05 specified a-priori|Chi-squared||Positive values reflect higher percentage of responders in Medical/Nursing clinics as compared to Medical/Social.|||1.4|-6.1|0.3
72535178|NCT02255422|144599542|SUPERIORITY||LS mean difference (net)|-0.015|STANDARD_ERROR_OF_MEAN|0.0446||0.7321|TWO_SIDED|95.0|-0.1051|0.0743||P-Value relates to difference in change in peak work from baseline relative to placebo for all doses pooled. Statistical significance was defined as p\<0.05|Mixed Models Analysis|Null hypothesis: wk 12 mean change from baseline (\[μ RTA 408\] - \[μ Placebo\]) in peak work = 0 w/kg. Positive change from baseline suggests improvement||Primary Objective: To evaluate the change in peak work during maximal exercise testing||0.0743|-0.1051|0.7321
72535179|NCT02255422|144599543|SUPERIORITY||LS mean difference (net)|-33.448|STANDARD_ERROR_OF_MEAN|11.6473||0.006|TWO_SIDED|95.0|-56.855|-10.042||P-value comparison is for difference in change in six minute walk distance from baseline within each dosage group relative to placebo. Statistical significance defined as p\<0.05.|Mixed Models Analysis|The change from baseline in 6MWT was analyzed using the same MMRM model used for the primary efficacy endpoint. Analysis visits 0, 4, 8 and 12 used.||Secondary Objective: To evaluate the change in 6-minute walk test (6MWT) distance at Week 4||-10.042|-56.855|0.0060
72535180|NCT02255422|144599543|SUPERIORITY||LS mean difference (net)|-3.963|STANDARD_ERROR_OF_MEAN|11.53||0.7325|TWO_SIDED|95.0|-27.133|19.207||Statistical significance was defined as p\<0.05. The p-value comparison is for the difference in change in 6MWD from baseline within each dosage group relative to placebo.|Mixed Models Analysis|The change from baseline in 6MWT was analyzed using the same MMRM model used for the primary efficacy endpoint. Analysis visits 0, 4, 8 and 12 used.||Secondary Objective: To evaluate the change in 6-minute walk test (6MWT) distance at Week 8||19.207|-27.133|0.7325
72535181|NCT02255422|144599543|SUPERIORITY||LS mean difference (net)|-18.594|STANDARD_ERROR_OF_MEAN|15.0004||0.221|TWO_SIDED|95.0|-48.739|11.55||Statistical significance was defined as p\<0.05. The p-value comparison is for the difference in change in 6MWD from baseline within each dosage group relative to placebo.|Mixed Models Analysis|The change from baseline in 6MWT was analyzed using the same MMRM model used for the primary efficacy endpoint. Analysis visits 0, 4, 8 and 12 used.||Secondary Objective: To evaluate the change in 6-minute walk test (6MWT) distance at Week 12||11.550|-48.739|0.2210
72535182|NCT04411641|144599544|SUPERIORITY|A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measures are reported and continued when previous outcome measure was statistically significant at 2-sided 0.05. Primary and first 6 secondary endpoints are included in this procedure.|Hazard Ratio (HR)|0.693||||0.0026|TWO_SIDED|95.0|0.546|0.88||Threshold for significance at 2-sided 0.05 level.|Regression, Cox|||Derived using Cox proportional-hazards model with robust variance estimation.Covariates were treatment group,age at screening (\>40,\<=40 years),geographic region (United States \[US\], non-US),baseline EDSS score \& baseline gadolinium (Gd)-enhancing T1 lesions (presence, absence).In this analysis, for participants who completed study with 3-month confirmation and continued to meet disability progression criteria throughout EOS, their 6-month CDP status was imputed via multiple imputation method.||0.880|0.546|0.0026
72535183|NCT04411641|144599545|SUPERIORITY|A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measures are reported and continued when previous outcome measure was statistically significant at 2-sided 0.05. Primary and first 6 secondary endpoints are included in this procedure.|Hazard Ratio (HR)|0.757||||0.0134|TWO_SIDED|95.0|0.607|0.944||Threshold for significance at 2-sided 0.05 level.|Regression, Cox|||Derived using Cox proportional-hazards model with robust variance estimation. Covariates were treatment group, age at screening (\>40, \<=40 years), geographic region (US, non-US), baseline EDSS score and baseline Gd-enhancing T1 lesions (presence, absence).||0.944|0.607|0.0134
72535184|NCT04411641|144599546|SUPERIORITY|A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measures are reported and continued when previous outcome measure was statistically significant at 2-sided 0.05. Primary and first 6 secondary endpoints are included in this procedure.|Relative Risk|0.622||||0.011|TWO_SIDED|95.0|0.432|0.897||Threshold for significance at 2-sided 0.05 level.|Chi-squared|||Derived using negative binomial model with the number of new and/or enlarging T2-hyperintense lesions between randomization date and EOS date as the response variable, treatment group, age at screening (\>40, \<=40 years), geographic region (US, non-US), baseline EDSS score, and baseline number of T2 lesions as covariates, and log transformed observation duration as the offset variable.||0.897|0.432|0.0110
72572933|NCT00536263|144673027|SUPERIORITY_OR_OTHER||Pairwise rate difference|0.139|||<|0.001|TWO_SIDED|95.0|0.061|0.217||P-values are unadjusted; Hochberg's adjustment for multiple comparisons was used to maintain the overall 0.05 significance level in test of superiority using the Cochran-Mantel-Haenszel test.|Cochran-Mantel-Haenszel|Stratified by genotype||"Null hypothesis: no difference in the proportion with HBeAg loss.~Based on the targeted sample size, there was 80% statistical power (2-sided 0.05 alpha) to detect a true 36% HBeAg loss rate in this treatment arm versus a true rate of 23% in the control arm."||0.217|0.061|<0.001
72535185|NCT04411641|144599547|SUPERIORITY|A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measures are reported and continued when previous outcome measure was statistically significant at 2-sided 0.05. Primary and first 6 secondary endpoints are included in this procedure.|Hazard Ratio (HR)|0.972||||0.8428|TWO_SIDED|95.0|0.735|1.286||Threshold for significance at 2-sided 0.05 level.|Regression, Cox|||Derived using Cox proportional-hazards model with robust variance estimation. Covariates were treatment group, age at screening (\>40, \<=40 years), geographic region (US, non-US), baseline EDSS score and baseline Gd-enhancing T1 lesions (presence, absence).||1.286|0.735|0.8428
72572934|NCT00536263|144673027|NON_INFERIORITY_OR_EQUIVALENCE|The noninferiority of PEG 1.5 mcg/kg\*24 weeks with respect to PEG 1.5 mcg/kg\*48 weeks was to be concluded if the lower bound of the one-sided 95% confidence interval of the difference of the rates (PEG 1.5 mcg/kg\*24 weeks minus PEG 1.5 mcg/kg\*48 weeks) was greater than the noninferiority margin of -10%.|Pairwise rate difference|-0.132|||||TWO_SIDED|90.0|-0.198|-0.065||||||||-0.065|-0.198|
72572935|NCT00536263|144673028|SUPERIORITY_OR_OTHER||Pairwise rate difference|-0.011||||0.7|TWO_SIDED|95.0|-0.074|0.052|||Cochran-Mantel-Haenszel|Stratified by genotype||||0.052|-0.074|0.700
72572936|NCT00536263|144673028|SUPERIORITY_OR_OTHER||Pairwise rate difference|0.054||||0.125|TWO_SIDED|95.0|-0.014|0.123|||Cochran-Mantel-Haenszel|Stratified by genotype||||0.123|-0.014|0.125
72572937|NCT00536263|144673028|SUPERIORITY_OR_OTHER||Pairwise rate difference|-0.065|||||TWO_SIDED|90.0|-0.122|-0.008||||||||-0.008|-0.122|
72572938|NCT00536263|144673029|SUPERIORITY_OR_OTHER||Pairwise rate difference|-0.016||||0.598|TWO_SIDED|95.0|-0.078|0.047|||Cochran-Mantel-Haenszel|Stratified by genotype||End of treatment||0.047|-0.078|0.598
72572939|NCT00536263|144673029|SUPERIORITY_OR_OTHER||Pairwise rate difference|0.041||||0.24|TWO_SIDED|95.0|-0.027|0.108|||Cochran-Mantel-Haenszel|Stratified by genotype||End of treatment||0.108|-0.027|0.24
72535186|NCT04411641|144599548|SUPERIORITY|A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measures are reported and continued when previous outcome measure was statistically significant at 2-sided 0.05. Primary and first 6 secondary endpoints are included in this procedure.|Hazard Ratio (HR)|0.767||||0.004|TWO_SIDED|95.0|0.64|0.919|||Regression, Cox|||Derived using Cox proportional-hazards model with robust variance estimation. Covariates were treatment group, age at screening (\>40, \<=40 years), geographic region (US, non-US), baseline EDSS score and baseline Gd-enhancing T1 lesions (presence, absence).||0.919|0.640|0.0040
72535187|NCT04411641|144599549|SUPERIORITY|A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measures are reported and continued when previous outcome measure was statistically significant at 2-sided 0.05. Primary and first 6 secondary endpoints are included in this procedure.|Hazard Ratio (HR)|1.882||||0.0206|TWO_SIDED|95.0|1.102|3.214|||Regression, Cox|||Derived using Cox proportional-hazards model with robust variance estimation. Covariates were treatment group, age at screening (\>40, \<=40 years), geographic region (US, non-US), baseline EDSS score and baseline Gd-enhancing T1 lesions (presence, absence).||3.214|1.102|0.0206
72572940|NCT00536263|144673029|SUPERIORITY_OR_OTHER||Pairwise rate difference|-0.056|||||TWO_SIDED|90.0|-0.112|-0.001||||||End of treatment||-0.001|-0.112|
72572941|NCT00536263|144673029|SUPERIORITY_OR_OTHER||Pairwise rate difference|-0.006||||0.83|TWO_SIDED|95.0|-0.075|0.063|||Cochran-Mantel-Haenszel|Stratified by genotype||24 weeks after EOT||0.063|-0.075|0.830
72572942|NCT00536263|144673029|SUPERIORITY_OR_OTHER||Pairwise rate difference|0.13||||0.001|TWO_SIDED|95.0|0.053|0.208|||Cochran-Mantel-Haenszel|Stratified by genotype||24 weeks after EOT||0.208|0.053|0.001
72572943|NCT00536263|144673029|SUPERIORITY_OR_OTHER||Pairwise rate difference|-0.136||||||90.0|-0.201|-0.071||||||24 weeks after EOT||-0.071|-0.201|
72572944|NCT00536263|144673030|SUPERIORITY_OR_OTHER||Pairwise rate difference|0.072||||0.076|TWO_SIDED|95.0|-0.007|0.151|||Cochran-Mantel-Haenszel|Stratified by genotype||End of treatment||0.151|-0.007|0.076
72572945|NCT00536263|144673030|SUPERIORITY_OR_OTHER||Pairwise rate difference|0.135||||0.001|TWO_SIDED|95.0|0.053|0.216|||Cochran-Mantel-Haenszel|Stratified by genotype||End of treatment||0.216|0.053|0.001
72572946|NCT00536263|144673030|SUPERIORITY_OR_OTHER||Pairwise rate difference|-0.063|||||TWO_SIDED|90.0|-0.135|0.009||||||End of treatment||0.009|-0.135|
72572947|NCT00536263|144673030|SUPERIORITY_OR_OTHER||Pairwise rate difference|0.017||||0.662|TWO_SIDED|95.0|-0.058|0.092|||Cochran-Mantel-Haenszel|Stratified by genotype||24 weeks after EOT||0.092|-0.058|0.662
72572948|NCT00536263|144673030|SUPERIORITY_OR_OTHER||Pairwise rate difference|0.139|||<|0.001|TWO_SIDED|95.0|0.059|0.22|||Cochran-Mantel-Haenszel|Stratified by genotype||24 weeks after EOT||0.220|0.059|<0.001
72572949|NCT00536263|144673030|SUPERIORITY_OR_OTHER||Pairwise rate difference|-0.122|||||TWO_SIDED|90.0|-0.191|-0.053||||||24 weeks after EOT||-0.053|-0.191|
72572950|NCT00536263|144673031|SUPERIORITY_OR_OTHER||Pairwise rate difference|0.019||||0.373|TWO_SIDED|95.0|-0.023|0.061|||Cochran-Mantel-Haenszel|Stratified by genotype||End of treatment||0.061|-0.023|0.373
72572951|NCT00536263|144673031|SUPERIORITY_OR_OTHER||Pairwise rate difference|0.049||||0.04|TWO_SIDED|95.0|0.003|0.096|||Cochran-Mantel-Haenszel|Stratified by genotype||End of treatment||0.096|0.003|0.040
72572952|NCT00536263|144673031|SUPERIORITY_OR_OTHER||Pairwise rate difference|-0.03|||||TWO_SIDED|90.0|-0.072|0.011||||||End of treatment||0.011|-0.072|
72408295|NCT00086580|144325000|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.08||||0.018|TWO_SIDED|95.0|0.02|0.15||P-value presented is adjusted for multiple tests using Hochberg procedure for 3 clinically important secondary endpoints: ORR, CR rates and OS.|Cochran-Mantel-Haenszel|CMH chi-square test for a difference in complete response rates between treatments stratified by Rai Stage Group.|Difference and confidence interval (CI) calculated using the recommended method by Altman et al.|Comparison of complete response (CR).||0.15|0.02|0.018
72408296|NCT00086580|144325001|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.648||||0.042|TWO_SIDED|95.0|0.449|0.937||P-value presented is adjusted for multiple tests using Hochberg procedure for 3 clinically important secondary endpoints: ORR, CR rates and OS.|Regression, Cox|Cox proportional hazards model stratified by Rai Stage Group||||0.937|0.449|0.042
72408297|NCT00086580|144325002|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.562|||<|0.001|TWO_SIDED|95.0|0.42|0.752|||Regression, Cox|Cox regression model stratified by Rai Stage Group.||||0.752|0.420|<0.001
72408298|NCT00086580|144325004|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.718||||0.021|TWO_SIDED|95.0|0.543|0.951|||Regression, Cox|Cox proportional hazards model stratified by Rai Stage Group.||||0.951|0.543|0.021
72408299|NCT00086580|144325012|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.75||||0.102|TWO_SIDED|95.0|0.531|1.059|||Regression, Cox|||||1.059|0.531|0.102
72408300|NCT00086580|144325013|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.443|||<|0.001|TWO_SIDED|95.0|0.292|0.671|||Regression, Cox|||||0.671|0.292|<0.001
72408301|NCT00086580|144325014|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.066||||0.819|TWO_SIDED|95.0|0.619|1.836|||Regression, Cox|Cox proportional hazards model||||1.836|0.619|0.819
72408302|NCT00086580|144325015|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.416|||<|0.001|TWO_SIDED|95.0|0.25|0.69|||Regression, Cox|Cox proportional hazards model||||0.690|0.250|<0.001
72408303|NCT00086580|144325018|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.04||||0.014|TWO_SIDED|95.0|0.01|0.08|||Cochran-Mantel-Haenszel|CMH chi-square test for a difference in response rates between treatments stratified by Rai Stage Group.||||0.08|0.01|0.014
72408304|NCT04452188|144325019|EQUIVALENCE|Prior studies suggest a 25-50% reduction in oxidative stress in normoxia relative to supra-physiologic oxygen. A 20% difference was considered clinically meaningful, and a sample size of 42 total participants was anticipated to achieve at least 80% power with a two-sided 5% significance level. However, an interim analysis recommended by the DSMB after enrollment of 29 patients revealed a significant difference in the primary outcome between the groups, and enrollment was thus stopped.|||||<|0.01||||||To provide a more conservative estimate of significance, the Hochberg sequential procedure was used for adjustment of multiple comparisons in the serum biomarker data including the primary outcome.|t-test, 2 sided|||Each participant's post-operative samples were normalized to their baseline sample and described as a fold-of-change from baseline.||||<0.01
72408305|NCT04452188|144325021|OTHER|||||||0.66|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon rank sum test was used to compare the post-operative length of stay between the two groups.||||0.66
72408306|NCT04452188|144325022|OTHER|||||||0.66|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon rank sum test was used to compare the days alive and out of ICU at 30 days since surgery between the two groups||||0.66
72408307|NCT04452188|144325023|OTHER|||||||1|||||||Fisher Exact|||||||1.00
72408308|NCT04452188|144325024|OTHER|||||||0.49|||||||Wilcoxon (Mann-Whitney)|||||||0.49
72408309|NCT04452188|144325025|OTHER||||||<|0.01||||||To provide a more conservative estimate of significance, the Hochberg sequential procedure was used for adjustment of multiple comparisons in the serum biomarker data including the primary outcome.|t-test, 2 sided|||||||<0.01
72408310|NCT04452188|144325026|OTHER||||||<|0.01||||||To provide a more conservative estimate of significance, the Hochberg sequential procedure was used for adjustment of multiple comparisons in the serum biomarker data including the primary outcome.|t-test, 2 sided|||||||<0.01
72408311|NCT04452188|144325027|OTHER||||||<|0.1||||||To provide a more conservative estimate of significance, the Hochberg sequential procedure was used for adjustment of multiple comparisons in the serum biomarker data including the primary outcome.|t-test, 2 sided|||||||<0.1
72408312|NCT02047110|144325029|SUPERIORITY_OR_OTHER||Risk Difference (RD)|7.5||||0.2652|TWO_SIDED|90.0|-12.1|26.6||The Suissa-Shuster unconditional exact test was used to test the difference in the proportion of patients achieving the primary endpoint, ASAS 40 response at Week 12, between treatment groups.|Suissa-Shuster unconditional exact test||"The confidence interval for the difference in proportion between the treatment groups was obtained by the Clopper-Pearson method. Difference calculated as risankizumab 18 mg minus Placebo."|To control the type I error rate, the primary endpoint was tested in a hierarchical fixed sequence approach. The proportion of patients achieving ASAS 40 response at Week 12 was pairwise compared in the following sequence: risankizumab 180 mg vs. placebo (1.) and risankizumab 90 mg vs. placebo (2.). The significance level was 5% (1-sided). The comparison risankizumab 18 mg vs. placebo was not included in the formal testing sequence; an exploratory p-value was provided.||26.6|-12.1|0.2652
72408313|NCT02047110|144325029|SUPERIORITY_OR_OTHER||Risk Difference (RD)|3.0||||0.4129|TWO_SIDED|90.0|-15.9|20.8||The Suissa-Shuster unconditional exact test was used to test the difference in the proportion of patients achieving the primary endpoint, ASAS 40 response at Week 12, between treatment groups.|Suissa-Shuster unconditional exact test||"The confidence interval for the difference in proportion between the treatment groups was obtained by the Clopper- Pearson method. Difference calculated as risankizumab 90 mg minus Placebo."|To control the type I error rate, the primary endpoint was tested in a hierarchical fixed sequence approach. The proportion of patients achieving ASAS 40 response at Week 12 was pairwise compared in the following sequence: risankizumab 180 mg vs. placebo (1.) and risankizumab 90 mg vs. placebo (2.). The significance level was 5% (1-sided). The comparison risankizumab 18 mg vs. placebo was not included in the formal testing sequence; an exploratory p-value was provided.||20.8|-15.9|0.4129
72535188|NCT04411641|144599550|SUPERIORITY|A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measures are reported and continued when previous outcome measure was statistically significant at 2-sided 0.05. Primary and first 6 secondary endpoints are included in this procedure.|LS Mean Difference|0.082||||0.1646|TWO_SIDED|95.0|-0.034|0.197|||Mixed model repeated measures (MMRM)|||Covariates in the mixed-effect model with repeated measures were treatment group, age at screening (\>40, \<=40 years), geographic region (US, non-US), visit, treatment-by-visit interaction, cube root transformed Month 6 brain volume, and cube root transformed Month 6 brain volume-by-visit interaction.||0.197|-0.034|0.1646
72535189|NCT03810417|144599561|SUPERIORITY||||||>|0.05|||||||Regression, Linear|||||||>0.05
72408314|NCT02047110|144325029|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-2.5||||0.4243|TWO_SIDED|90.0|-21.8|17.0||The Suissa-Shuster unconditional exact test was used to test the difference in the proportion of patients achieving the primary endpoint, ASAS 40 response at Week 12, between treatment groups|Suissa-Shuster unconditional exact test||"The confidence interval for the difference in proportion between the treatment groups was obtained by the Clopper- Pearson method. Difference calculated as risankizumab 180 mg minus Placebo."|To control the type I error rate, the primary endpoint was tested in a hierarchical fixed sequence approach. The proportion of patients achieving ASAS 40 response at Week 12 was pairwise compared in the following sequence: risankizumab 180 mg vs. placebo (1.) and risankizumab 90 mg vs. placebo (2.). The significance level was 5% (1-sided). The comparison risankizumab 18 mg vs. placebo was not included in the formal testing sequence; an exploratory p-value was provided.||17.0|-21.8|0.4243
72408315|NCT02047110|144325030|SUPERIORITY_OR_OTHER||Median estimate by Hodges-Lehmann method|-0.4||||0.0229|TWO_SIDED|90.0|-0.7|-0.1||One sided p-value from Wilcoxon rank-sum test|Wilcoxon rank-sum test||"The confidence interval for the difference in proportion between the treatment groups was obtained by the Moses method. Difference calculated as risankizumab 18 mg minus Placebo."|||-0.1|-0.7|0.0229
72408316|NCT02047110|144325030|SUPERIORITY_OR_OTHER||Median estimate by Hodges-Lehmann method|-0.3||||0.1038|TWO_SIDED|90.0|-0.6|0.1||One sided p-value from Wilcoxon rank-sum test|Wilcoxon rank-sum test||"The confidence interval for the difference in proportion between the treatment groups was obtained by the Moses method. Difference calculated as risankizumab 90 mg minus Placebo."|||0.1|-0.6|0.1038
72535190|NCT03810417|144599561|SUPERIORITY||||||<|0.05|||||||Regression, Logistic|||||||<0.05
72535191|NCT01195662|144599565|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.28|STANDARD_ERROR_OF_MEAN|1.1485||0.0002|TWO_SIDED|95.0|-6.54|-2.02||Endpoint was tested at alpha=0.05. Hierarchical closed testing procedure used.|Longitudinal repeated measures|Data from all weeks during the double-blind treatment period were included.||Longitudinal repeated measures analysis using 'direct likelihood', with fixed categorical effects of treatment, week, treatment-by-week interaction, and randomization strata, as well as continuous fixed covariates of baseline SBP value and baseline SBP value-by-week interaction. Unstructured matrix for within-subject error variance-covariance used. 80% power to detect a difference of 4 mmHg in mean change from baseline, 75% power to meet both co-primary endpoints with overall Type I error.||-2.02|-6.54|0.0002
72535192|NCT01195662|144599566|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.61|STANDARD_ERROR_OF_MEAN|0.0773|<|0.0001|TWO_SIDED|95.0|-0.76|-0.46|||Longitudinal repeated measures|Endpoint was tested at alpha=0.05. Hierarchical closed testing procedure was used.||A longitudinal repeated measures analysis used, with fixed categorical effects of treatment, week, treatment-by-week interaction, and randomization strata, continuous fixed covariates of baseline HbA1c value and baseline HbA1c value-by-week interaction. Only data up to Week 12 included. All data used in the model even if participants discontinued prior to Week 12. A heirarchical closed testing procedure (sequential) was used and testing performed since first primary endpoint was significant.||-0.46|-0.76|<0.0001
72535193|NCT01195662|144599567|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.45|STANDARD_ERROR_OF_MEAN|1.368||0.0012|TWO_SIDED|95.0|-7.14|-1.76||Endpoint tested following a sequential testing procedure at alpha=0.05.|ANCOVA|||ANCOVA model with treatment group as an effect and baseline value and randomization strata as a covariate was used. By applying sequential testing procedure, the testing was performed since the prior endpoint was significant.||-1.76|-7.14|0.0012
72535194|NCT01195662|144599568|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.97|STANDARD_ERROR_OF_MEAN|0.69||0.1619|TWO_SIDED|95.0|-2.32|0.39||Endpoint tested following a sequential testing procedure at alpha=0.05.|Longitudinal repeated measures|||Longitudinal repeated measures analysis using direct likelihood with fixed categorical effects of treatment, week, treatment-by week interaction, and randomization strata and continuous fixed covariates of baseline seated diastolic BP value and baseline seated diastolic BP value by week interaction.||0.39|-2.32|0.1619
72535195|NCT01195662|144599569|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.99|STANDARD_ERROR_OF_MEAN|0.8635|||TWO_SIDED|95.0|-3.68|-0.29|||ANCOVA|||ANCOVA model with treatment group as an effect and baseline value and randomization strata as a covariate. A hierarchical closed testing procedure was implemented to control the family-wise type I error rate related to the co-primary and secondary endpoints at the 2-sided 0.05 level. Statistical testing of this endpoint was not performed since the prior secondary endpoint was not statistically significant.||-0.29|-3.68|
72535196|NCT01195662|144599570|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.0858|||TWO_SIDED|95.0|-0.57|-0.23|||lLongitudinal repeated measures|||Longitudinal repeated measures analysis using direct likelihood with fixed categorical effects of treatment, week, treatment-by week interaction, and randomization strata and continuous fixed covariates of baseline serum uric acid value and baseline seated serum uric acid value by week interaction. By applying sequential testing procedure at alpha=0.05, no testing was performed since the prior secondary endpoint was not significant.||-0.23|-0.57|
72408317|NCT02047110|144325030|SUPERIORITY_OR_OTHER||Median estimate by Hodges-Lehmann method|-0.5||||0.0101|TWO_SIDED|90.0|-0.7|-0.1||One sided p-value from Wilcoxon rank-sum test|Wilcoxon rank-sum test||"The confidence interval for the difference in proportion between the treatment groups was obtained by the Moses method. Difference calculated as risankizumab 180 mg minus Placebo."|||-0.1|-0.7|0.0101
72535197|NCT01215968|144599576|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Mean|2.19|||||TWO_SIDED|90.0|1.83|2.62|||Mixed Linear effects model analyses|Ratio is the Geometric LS Means of Day 10 over Day 3.||||2.62|1.83|
72535198|NCT01215968|144599576|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Mean|1.94|||||TWO_SIDED|90.0|1.61|2.33|||Mixed Linear effects model analyses|Ratio is the Geometric LS Means of Day 17 over Day 3.||||2.33|1.61|
72535199|NCT01215968|144599576|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Mean|1.91|||||TWO_SIDED|90.0|1.59|2.29|||Mixed Linear effects model analyses|Ratio is the Geometric LS Means of Day 24 over Day 3.||||2.29|1.59|
72535200|NCT01215968|144599576|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Mean|1.84|||||TWO_SIDED|90.0|1.52|2.22|||Mixed Linear effects model analyses|Ratio is the Geometric LS Means of Day 31 over Day 3.||||2.22|1.52|
72535201|NCT05643573|144599586|SUPERIORITY||Cox Proportional Hazard|3.785|||<|0.0001|TWO_SIDED|95.0|2.457|5.833|||Log Rank|||Comparison of Asundexian 50 mg verus Apixaban||5.833|2.457|<.0001
72535202|NCT05643573|144599586|SUPERIORITY||Fine-Gray model|3.79|||<|0.0001|TWO_SIDED|95.0|2.46|5.839|||Gray's test|||Comparison of Asundexian 50 mg verus Apixaban||5.839|2.460|<.0001
72535203|NCT05643573|144599587|SUPERIORITY||Fine-Gray model|0.319|||<|0.0001|TWO_SIDED|95.0|0.185|0.552|||Log Rank|||Comparison of Asundexian 50 mg verus Apixaban||0.552|0.185|<.0001
72535204|NCT05643573|144599587|SUPERIORITY||Fine-Gray model|0.316|||<|0.0001|TWO_SIDED|95.0|0.182|0.547|||Gray's test|||Comparison of Asundexian 50 mg verus Apixaban||0.547|0.182|<.0001
72535205|NCT05643573|144599588|SUPERIORITY||Fine-Gray model|1.61||||0.0011|TWO_SIDED|95.0|1.207|2.149|||Log Rank|||Comparison of Asundexian 50 mg verus Apixaban||2.149|1.207|0.0011
72535206|NCT05643573|144599588|SUPERIORITY||Fine-Gray model|1.599||||0.0013|TWO_SIDED|95.0|1.197|2.134|||Gray's test|||Comparison of Asundexian 50 mg verus Apixaban||2.134|1.197|0.0013
72535207|NCT04089566|144599622|SUPERIORITY|The Analysis of Covariance (ANCOVA) model used rank score as response, treatment as fixed effect and disease duration at screening, baseline Hammersmith Infant Neurological Examination (HINE) Section 2 (HINE 2), baseline CHOP INTEND total score as covariates.|Least square (LS) mean difference|26.06|STANDARD_ERROR_OF_MEAN|4.141|<|0.0001|TWO_SIDED|95.0|17.941|34.172|||ANCOVA|||||34.172|17.941|< 0.0001
72535208|NCT04089566|144599645|SUPERIORITY||Difference of percentages|58.0|||<|0.0001|TWO_SIDED|95.0|39.46|71.81|||Fisher Exact||Exact unconditional confidence interval|||71.81|39.46|<0.0001
72408318|NCT02047110|144325031|SUPERIORITY_OR_OTHER||Risk Difference (RD)|15.0||||0.0238|TWO_SIDED|90.0|-4.6|33.8||The Suissa-Shuster unconditional exact test was used to test the difference in the proportion of patients achieving the endpoint at Week 12, between treatment groups.|Suissa-Shuster unconditional exact test||"The confidence interval for the difference in proportion between the treatment groups was obtained by the Clopper-Pearson method. Difference calculated as risankizumab 18 mg minus Placebo."|||33.8|-4.6|0.0238
72408319|NCT02047110|144325031|SUPERIORITY_OR_OTHER||Risk Difference (RD)|18.1||||0.012|TWO_SIDED|90.0|-0.8|35.3||The Suissa-Shuster unconditional exact test was used to test the difference in the proportion of patients achieving the endpoint at Week 12, between treatment groups.|Suissa-Shuster unconditional exact test||"The confidence interval for the difference in proportion between the treatment groups was obtained by the Clopper- Pearson method. Difference calculated as risankizumab 90 mg minus Placebo."|||35.3|-0.8|0.0120
72535209|NCT04089566|144599646|SUPERIORITY||LS mean difference|26.67|STANDARD_ERROR_OF_MEAN|4.009|<|0.0001|TWO_SIDED|95.0|18.812|34.526||ANCOVA model was used treatment as fixed effect and disease duration at screening, baseline HINE 2, baseline CHOP INTEND total score as covariates.|ANCOVA|||||34.526|18.812|<0.0001
72535210|NCT04089566|144599647|SUPERIORITY||LS geometric mean ratio|0.08|||<|0.0001||||||ANCOVA model was used with treatment as a fixed effect and adjusted for each participant disease duration at screening, baseline log plasma NF-L and baseline CHOP INTEND total score.|ANCOVA|||||||<0.0001
72535211|NCT04089566|144599648|SUPERIORITY||LS mean difference|1.0|STANDARD_ERROR_OF_MEAN|5.251|=|0.8484|TWO_SIDED|95.0|-9.29|11.299||ANCOVA model used rank score as response, treatment as fixed effect and disease duration at screening, baseline HINE 2, baseline CHOP INTEND total score as covariates.|ANCOVA|||||11.299|-9.29|=0.8484
72535212|NCT04089566|144599649|SUPERIORITY||LS mean difference|6.12|STANDARD_ERROR_OF_MEAN|4.497|=|0.1734|TWO_SIDED|95.0|-2.693|14.939||ANCOVA model used rank score as response, treatment as fixed effect and disease duration at screening, baseline HINE 2, baseline CHOP INTEND total score as covariates.|ANCOVA|||||14.939|-2.693|=0.1734
72535213|NCT04089566|144599650|SUPERIORITY||LS geometric mean ratio|0.51|||=|0.002|TWO_SIDED|95.0|0.33|0.78||ANCOVA model was used with treatment as a fixed effect and adjustment for each participant disease duration at screening, baseline log plasma NF-L and baseline CHOP INTEND total score.|ANCOVA|||||0.78|0.33|=0.002
72535214|NCT04089566|144599693|SUPERIORITY||LS geometric mean ratio|0.86|||=|0.3785|TWO_SIDED|95.0|0.62|1.2||ANCOVA model was used with treatment as a fixed effect and adjusted for each participant disease duration at screening, baseline log CSF NF-L and baseline CHOP INTEND total score.|ANCOVA|||||1.2|0.62|=0.3785
72535215|NCT00056472|144599712|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.28|||<|0.001||95.0|1.12|1.47|||Regression, Logistic|||Predicting remission rates of 40% in combination therapy and 20% in monotherapy subjects, 260 subjects randomized into the two treatment groups would provide \>80% power at a two-tailed alpha level of .05. Treatment efficacy was compared between groups based on intent-to-treat analyses for the longitudinal binary outcome of remission using mixed effects logistic regression with a random intercept that included treatment and time as fixed effects and a treatment by time interaction effect.||1.47|1.12|<.001
72535216|NCT00056472|144599713|SUPERIORITY_OR_OTHER|||||||0.02||95.0||||The p-value is for the overall mean CGI-S score compared to baseline.|Mixed Models Analysis|This was a longitudinal analysis of CGI-S scores compared to baseline.||Intent-to-treat changes in global improvement from week to week compared to baseline (CGI-S) over the course of the trial using longitudinal mixed effects linear regression models. The null hypothesis is that there is no difference in overall change in CGI-S.||||.02
72535217|NCT00056472|144599714|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The p-value is for the overall mean across all time points between each treatment group.|Mixed Models Analysis|||Intent-to-treat between group comparison using longitudinal mixed effects regression.||||<.001
72535218|NCT03677440|144599715|SUPERIORITY|||||||0.34|||||||ANOVA|||This involves a repeated-measures ANOVA testing a condition (i.e., treadmill walking exercise training vs. stretching-and-toning exercise training)-by-time (i.e., baseline, follow-up) interaction on Symbol Digit Modalities Test scores.||||.34
72535219|NCT03677440|144599716|SUPERIORITY|||||||0.01|||||||t-test, 1 sided|||||||.01
72535220|NCT03677440|144599717|SUPERIORITY|||||||0.02|||||||t-test, 1 sided|||||||.02
72535221|NCT03677440|144599718|SUPERIORITY|||||||0.63|||||||ANOVA|||||||.63
72535222|NCT03677440|144599719|SUPERIORITY||Partial eta-squared|0.067||||0.2|TWO_SIDED||||||ANOVA|||||||.20
72535223|NCT03677440|144599720|SUPERIORITY|||||||0.96|||||||ANOVA|||||||.96
72535224|NCT03677440|144599721|SUPERIORITY|||||||0.55|||||||ANOVA|||||||.55
72535225|NCT03677440|144599722|SUPERIORITY||Partial eta-squared|0.087||||0.14|TWO_SIDED||||||ANOVA|||||||.14
72535226|NCT03677440|144599723|SUPERIORITY|||||||0.69|||||||ANOVA|||||||.69
72535227|NCT03677440|144599724|SUPERIORITY||Partial eta-squared|0.048||||0.28|TWO_SIDED||||||ANOVA|||||||.28
72535228|NCT01875731|144599734|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.09||||0.01|TWO_SIDED|95.0|1.57|16.8|||Chi-squared|||||16.8|1.57|0.01
72535229|NCT01875731|144599735|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.7||||0.71|TWO_SIDED|95.0|0.1|4.09|||Chi-squared|||||4.09|0.1|0.71
72535230|NCT01441882|144599748|NON_INFERIORITY|A non-parametric two-sided Mann-Whitney test was run assuming non-Gaussian distributions. Two-tailed with 95% confidence intervals.||||||0.0106|TWO_SIDED|95.0|||||t-test, 2 sided|Threshold for statistical significance is 0.05.||Percent change from baseline in responders compared to non-responders (lymph node size).||||0.0106
72535231|NCT01441882|144599748|NON_INFERIORITY|A non-parametric two-sided Mann-Whitney test was run assuming non-Gaussian distributions. Two-tailed with 95% confidence intervals.||||||0.1986|TWO_SIDED|95.0|||||t-test, 2 sided|Threshold for statistical significance is 0.05.||Percent change from baseline in responders compared to non-responders (Absolute Lymphocyte Count (ALC)).||||0.19860
72535232|NCT01441882|144599748|NON_INFERIORITY|A non-parametric two-sided Mann-Whitney test was run assuming non-Gaussian distributions. Two-tailed with 95% confidence intervals.||||||0.5167|TWO_SIDED|95.0|||||t-test, 2 sided|Threshold for statistical significance is 0.05.||Percent change from baseline in responders compared to non-responders (spleen size).||||0.5167
72535233|NCT05981365|144599795|OTHER||Ratio of Geometric LS Means|1.2629|||||TWO_SIDED|90.0|1.1673|1.3663||||||Analysis was performed using linear mixed model, with treatment as fixed effect and participant as random effect.||1.3663|1.1673|
72535234|NCT05981365|144599795|OTHER||Ratio of Geometric LS Means|1.1845|||||TWO_SIDED|95.0|1.0758|1.3042||||||Analysis was performed using linear mixed model, with treatment as fixed effect and participant as random effect.||1.3042|1.0758|
72535235|NCT05981365|144599796|OTHER||Ratio of Geometric LS Means|1.1929|||||TWO_SIDED|90.0|1.0215|1.393||||||Analysis was performed using linear mixed model, with treatment as fixed effect and participant as random effect.||1.3930|1.0215|
72535236|NCT05981365|144599797|OTHER||Ratio of Geometric LS Means|1.1311|||||TWO_SIDED|90.0|1.0496|1.2189||||||Analysis was performed using linear mixed model, with treatment as fixed effect and participant as random effect.||1.2189|1.0496|
72535237|NCT05981365|144599798|OTHER||Ratio of Geometric LS Means|0.8228||||||90.0|0.6992|0.9683||||||Analysis was performed using linear mixed model, with treatment as fixed effect and participant as random effect.||0.9683|0.6992|
72535238|NCT05981365|144599799|OTHER||Ratio of Geometric LS Means|1.5738|||||TWO_SIDED|90.0|1.4523|1.7054||||||Analysis was performed using linear mixed model, with treatment as fixed effect and participant as random effect.||1.7054|1.4523|
72535239|NCT05981365|144599800|OTHER||Ratio of Geometric LS Means|1.1491|||||TWO_SIDED|90.0|1.0807|1.222||||||Analysis was performed using linear mixed model, with treatment as fixed effect and participant as random effect.||1.2220|1.0807|
72535240|NCT05981365|144599800|OTHER||Ratio of Geometric LS Means|0.9494|||||TWO_SIDED|90.0|0.8759|1.0291||||||Analysis was performed using linear mixed model, with treatment as fixed effect and participant as random effect.||1.0291|0.8759|
72535241|NCT05981365|144599801|OTHER||Ratio of Geometric LS Means|1.3316|||||TWO_SIDED|90.0|1.2558|1.4121||||||Analysis was performed using linear mixed model, with treatment as fixed effect and participant as random effect.||1.4121|1.2558|
72535242|NCT05981365|144599802|OTHER||Ratio of Geometric LS Means|1.1282|||||TWO_SIDED|90.0|1.07|1.1896||||||Analysis was performed using linear mixed model, with treatment as fixed effect and participant as random effect.||1.1896|1.0700|
72535243|NCT05981365|144599803|OTHER||Ratio of Geometric LS Means|0.8047|||||TWO_SIDED|90.0|0.7173|0.9027||||||Analysis was performed using linear mixed model, with treatment as fixed effect and participant as random effect.||0.9027|0.7173|
72535244|NCT05981365|144599804|OTHER||Ratio of Geometric LS Means|2.0611|||||TWO_SIDED|90.0|1.8789|2.2609||||||Analysis was performed using linear mixed model, with treatment as fixed effect and participant as random effect.||2.2609|1.8789|
72535245|NCT05981365|144599805|OTHER||Ratio of Geometric LS Means|1.1374|||||TWO_SIDED|90.0|1.0672|1.2122||||||Analysis was performed using linear mixed model, with treatment as fixed effect and participant as random effect.||1.2122|1.0672|
72535246|NCT05981365|144599805|OTHER||Ratio of Geometric LS Means|0.9371|||||TWO_SIDED|90.0|0.8643|1.0162||||||Analysis was performed using linear mixed model, with treatment as fixed effect and participant as random effect.||1.0162|0.8643|
72535247|NCT05981365|144599806|OTHER||Ratio of Geometric LS Means|1.2713|||||TWO_SIDED|90.0|1.1939|1.3538||||||Analysis was performed using linear mixed model, with treatment as fixed effect and participant as random effect.||1.3538|1.1939|
72535248|NCT05981365|144599807|OTHER||Ratio of Geometric LS Means|1.127|||||TWO_SIDED|90.0|1.0688|1.1883||||||Analysis was performed using linear mixed model, with treatment as fixed effect and participant as random effect.||1.1883|1.0688|
72535249|NCT05981365|144599808|OTHER||Ratio of Geometric LS Means|0.7973|||||TWO_SIDED|90.0|0.7039|0.9031||||||Analysis was performed using linear mixed model, with treatment as fixed effect and participant as random effect.||0.9031|0.7039|
72535250|NCT05981365|144599809|OTHER||Ratio of Geometric LS Means|2.026|||||TWO_SIDED|90.0|1.8496|2.2193||||||Analysis was performed using linear mixed model, with treatment as fixed effect and participant as random effect.||2.2193|1.8496|
72535251|NCT05981365|144599810|OTHER||Ratio of Geometric LS Means|0.7909|||||TWO_SIDED|90.0|0.716|0.8737||||||Analysis was performed using linear mixed model, with treatment as fixed effect and participant as random effect.||0.8737|0.7160|
72535252|NCT05981365|144599811|OTHER||Ratio of Geometric LS Means|1.0831|||||TWO_SIDED|90.0|0.9723|1.2065||||||Analysis was performed using linear mixed model, with treatment as fixed effect and participant as random effect.||1.2065|0.9723|
72535253|NCT05981365|144599812|OTHER||Ratio of Geometric LS Means|1.3138|||||TWO_SIDED|90.0|1.1871|1.4541||||||Analysis was performed using linear mixed model, with treatment as fixed effect and participant as random effect.||1.4541|1.1871|
72535254|NCT05981365|144599813|OTHER||Ratio of Geometric LS Means|0.7958|||||TWO_SIDED|90.0|0.742|0.8534||||||Analysis was performed using linear mixed model, with treatment as fixed effect and participant as random effect.||0.8534|0.7420|
72535255|NCT05981365|144599814|OTHER||Ratio of Geometric LS Means|1.0322|||||TWO_SIDED|90.0|0.9531|1.1179||||||Analysis was performed using linear mixed model, with treatment as fixed effect and participant as random effect.||1.1179|0.9531|
72535256|NCT05981365|144599815|OTHER||Ratio of Geometric LS Means|1.1975|||||TWO_SIDED|90.0|1.0972|1.3069||||||Analysis was performed using linear mixed model, with treatment as fixed effect and participant as random effect.||1.3069|1.0972|
72535257|NCT05981365|144599816|OTHER||Ratio of Geometric LS Means|0.8018|||||TWO_SIDED|90.0|0.7472|0.8604||||||Analysis was performed using linear mixed model, with treatment as fixed effect and participant as random effect.||0.8604|0.7472|
72535258|NCT05981365|144599817|OTHER||Ratio of Geometric LS Means|1.063|||||TWO_SIDED|90.0|0.9888|1.1427||||||Analysis was performed using linear mixed model, with treatment as fixed effect and participant as random effect.||1.1427|0.9888|
72535259|NCT05981365|144599818|OTHER||Ratio of Geometric LS Means|1.2197|||||TWO_SIDED|90.0|1.1114|1.3385||||||Analysis was performed using linear mixed model, with treatment as fixed effect and participant as random effect.||1.3385|1.1114|
72535260|NCT01005810|144599890|SUPERIORITY||Odds Ratio (OR)|2.35||||0.029|TWO_SIDED|95.0|1.05|5.24|||Regression, Logistic|||||5.24|1.05|0.029
72535261|NCT01453296|144599904|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.5|||||TWO_SIDED|95.0|-0.8|5.7|||||Day 1 maximum HR (0-2 hr). The estimated value represents the treatment difference: VI 25 µg minus placebo.|||5.7|-0.8|
72535262|NCT01453296|144599904|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.6|||||TWO_SIDED|95.0|-2.4|3.7|||||Day 14 maximum HR (0-2 hr). The estimated value represents the treatment difference: VI 25 µg minus placebo.|||3.7|-2.4|
72535263|NCT01453296|144599904|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.5|||||TWO_SIDED|95.0|-2.6|3.6|||||Day 14 maximum HR (0-8 hr). The estimated value represents the treatment difference: VI 25 µg minus placebo.|||3.6|-2.6|
72535264|NCT01453296|144599905|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.5|||||TWO_SIDED|95.0|-0.8|5.7|||||Day 1 weighted HR (0-2 hr). The estimated value represents the treatment difference: VI 25 µg minus placebo.|||5.7|-0.8|
72572953|NCT00536263|144673031|SUPERIORITY_OR_OTHER||Pairwise rate difference|0.001||||0.969|TWO_SIDED|95.0|-0.041|0.043|||Cochran-Mantel-Haenszel|Stratified by genotype||24 weeks after EOT||0.043|-0.041|0.969
72572954|NCT00536263|144673031|SUPERIORITY_OR_OTHER||Pairwise rate difference|0.045||||0.074|TWO_SIDED|95.0|-0.004|0.094|||Cochran-Mantel-Haenszel|Stratified by genotype||24 weeks after EOT||0.094|-0.004|0.074
72572955|NCT00536263|144673031|SUPERIORITY_OR_OTHER||Pairwise rate difference|-0.044|||||TWO_SIDED|90.0|-0.085|-0.003||||||24 weeks after EOT||-0.003|-0.085|
72572956|NCT00536263|144673032|SUPERIORITY_OR_OTHER||Pairwise rate difference|-0.004||||0.724|TWO_SIDED|95.0|-0.027|0.019|||Cochran-Mantel-Haenszel|Stratified by genotype||End of treatment||0.019|-0.027|0.724
72535265|NCT01453296|144599905|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.6|||||TWO_SIDED|95.0|-2.4|3.7|||||Day 14 weighted HR (0-2 hr). The estimated value represents the treatment difference: VI 25 µg minus placebo.|||3.7|-2.4|
72535266|NCT01453296|144599905|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.5|||||TWO_SIDED|95.0|-2.6|3.6|||||Day 14 weighted HR (0-8 hr). The estimated value represents the treatment difference: VI 25 µg minus placebo.|||3.6|-2.6|
72535267|NCT01453296|144599906|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.0|||||TWO_SIDED|95.0|-4.5|6.6|||||Day 1 maximum QTcF (0-2 hr). The estimated value represents the treatment difference: VI 25 µg minus placebo.|||6.6|-4.5|
72535268|NCT01453296|144599906|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.6|||||TWO_SIDED|95.0|-3.2|6.3|||||Day 14 maximum QTcF (0-2 hr). The estimated value represents the treatment difference: VI 25 µg minus placebo.|||6.3|-3.2|
72535269|NCT01453296|144599906|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.3|||||TWO_SIDED|95.0|-3.0|5.7|||||Day 14 maximum QTcF (0-8 hr). The estimated value represents the treatment difference: VI 25 µg minus placebo.|||5.7|-3.0|
72535270|NCT01453296|144599920|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.01|||||TWO_SIDED|95.0|-2.59|6.61|||||Day 1 weighted QTcF (0-2 hr). The estimated value represents the treatment difference: VI 25 µg minus placebo.|||6.61|-2.59|
72535271|NCT01453296|144599920|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.94|||||TWO_SIDED|95.0|-1.93|7.81|||||Day 14 weighted QTcF (0-2 hr). The estimated value represents the treatment difference: VI 25 µg minus placebo.|||7.81|-1.93|
72535272|NCT01453296|144599920|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.19|||||TWO_SIDED|95.0|-0.7|7.08|||||Day 14 weighted QTcF (0-8 hr). The estimated value represents the treatment difference: VI 25 µg minus placebo.|||7.08|-0.70|
72535273|NCT03557775|144599921|SUPERIORITY|||||||0.041||||||Result for time by group interaction (threshold for statistical significance set at 0.05).|ANOVA|||Null hypothesis: there will be no significant time by group interaction effect for this variable.||||0.041
72535274|NCT03557775|144599922|SUPERIORITY|||||||0.887||||||Result for time by group interaction. Statistical threshold set at 0.05.|ANOVA|||Null hypothesis: there will be no significant time by group interaction effect for this variable.||||0.887
72535275|NCT03557775|144599923|SUPERIORITY|||||||0.733||||||Result for time by group interaction effect. Threshold for statistical significance was set at 0.05.|ANOVA|||Null hypothesis: there will be no significant time by group interaction effect for this variable.||||0.733
72535276|NCT03557775|144599924|SUPERIORITY|||||||0.702||||||Result for time by group interaction effect. Threshold for statistical significance set at 0.05.|ANOVA|||Null hypothesis: there will be no significant time by group interaction effect for this variable.||||0.702
72535277|NCT03557775|144599925|SUPERIORITY|||||||0.198||||||Result for time by group interaction effect. Threshold for statistical significance set at 0.05.|ANOVA|||Null hypothesis: there will be no significant time by group interaction effect for this variable.||||0.198
72535278|NCT03557775|144599926|SUPERIORITY|||||||0.388||||||Result for time by group interaction effect. Threshold for statistical significance set at 0.05.|ANOVA|||Null hypothesis: there will be no significant time by group interaction effect for this variable.||||0.388
72572957|NCT00536263|144673032|SUPERIORITY_OR_OTHER||Pairwise rate difference|0.018||||0.243|TWO_SIDED|95.0|-0.012|0.048|||Cochran-Mantel-Haenszel|Stratified by genotype||End of treatment||0.048|-0.012|0.243
72572958|NCT00536263|144673032|SUPERIORITY_OR_OTHER||Pairwise rate difference|-0.022|||||TWO_SIDED|90.0|-0.046|0.002||||||End of treatment||0.002|-0.046|
72572959|NCT00536263|144673032|SUPERIORITY_OR_OTHER||Pairwise rate difference|-0.004||||0.724|TWO_SIDED|95.0|-0.027|0.019|||Cochran-Mantel-Haenszel|Stratified by genotype||24 weeks after EOT||0.019|-0.027|0.724
72572960|NCT00536263|144673032|SUPERIORITY_OR_OTHER||Pairwise rate difference|0.018||||0.232|TWO_SIDED|95.0|-0.012|0.048|||Cochran-Mantel-Haenszel|Stratified by genotype||24 weeks after EOT||0.048|-0.012|0.232
72572961|NCT00536263|144673032|SUPERIORITY_OR_OTHER||Pairwise rate difference|-0.022|||||TWO_SIDED|90.0|-0.046|0.002||||||24 weeks after EOT||0.002|-0.046|
72408320|NCT02047110|144325031|SUPERIORITY_OR_OTHER||Risk Difference (RD)|12.5||||0.0465|TWO_SIDED|90.0|-7.1|31.4||The Suissa-Shuster unconditional exact test was used to test the difference in the proportion of patients achieving the endpoint at Week 12, between treatment groups|Suissa-Shuster unconditional exact test||"The confidence interval for the difference in proportion between the treatment groups was obtained by the Clopper- Pearson method. Difference calculated as risankizumab 180 mg minus Placebo."|||31.4|-7.1|0.0465
72408321|NCT02047110|144325032|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.0|||||TWO_SIDED|90.0|-19.4|19.4|||||"The confidence interval for the difference in proportion between the treatment groups was obtained by the Clopper-Pearson method. Difference calculated as risankizumab 18 mg minus Placebo."|p-values are not presented as they were not meaningful; 3 treatment groups had only a single patient with partial remission.||19.4|-19.4|
72535279|NCT03557775|144599927|SUPERIORITY|||||||0.296||||||Result for time by group interaction effect. Threshold for statistical significance set at 0.05.|ANOVA|||Null hypothesis: there will be no significant time by group interaction effect for this variable.||||0.296
72535280|NCT03557775|144599928|SUPERIORITY|||||||0.04||||||Result for time by group interaction effect. Threshold for statistical significance set at 0.05.|ANOVA|||Null hypothesis: there will be no significant time by group interaction effect for this variable.||||0.040
72535281|NCT03557775|144599929|SUPERIORITY|||||||0.887||||||Result for time by group interaction effect. Threshold for statistical significance set at 0.05.|ANOVA|||Null hypothesis: there will be no significant time by group interaction effect for this variable.||||0.887
72535282|NCT03557775|144599930|SUPERIORITY|||||||0.663||||||Result for time by group interaction effect. Threshold for statistical significance was set 0.05.|ANOVA|||Null hypothesis: there will be no significant time by group interaction effect for this variable.||||0.663
72535283|NCT03557775|144599931|SUPERIORITY|||||||0.026||||||Result for time by group interaction effect. Threshold for statistical significance set at 0.05.|ANOVA|||Null hypothesis: there will be no significant time by group interaction effect for this variable.||||0.026
72535284|NCT03557775|144599932|SUPERIORITY|||||||0.721||||||Result for time by group interaction effect. Threshold for statistical significance set at 0.05.|ANOVA|||Null hypothesis: there will be no significant time by group interaction effect for this variable.||||0.721
72535285|NCT03557775|144599933|SUPERIORITY|||||||0.408||||||Result for time by group interaction effect. Threshold for statistical significance set at 0.05.|ANOVA|||Null hypothesis: there will be no significant time by group interaction effect for this variable.||||0.408
72535286|NCT03557775|144599934|SUPERIORITY|||||||0.638||||||Result for time by group interaction effect. Threshold for statistical significance set at 0.05.|ANOVA|||Null hypothesis: there will be no significant time by group interaction effect for this variable.||||0.638
72535287|NCT03557775|144599935|SUPERIORITY|||||||0.715||||||Result for time by group interaction effect. Threshold for statistical significance set at 0.05.|ANOVA|||Null hypothesis: there will be no significant time by group interaction effect for this variable.||||0.715
72535288|NCT03557775|144599936|SUPERIORITY|||||||0.708||||||Result for time by group interaction effect. Threshold for statistical significance set at 0.05.|ANOVA|||Null hypothesis: there will be no significant time by group interaction effect for this variable.||||0.708
72572962|NCT00536263|144673033|SUPERIORITY_OR_OTHER||Pairwise rate difference|0.056||||0.219|TWO_SIDED|95.0|-0.033|0.145|||Cochran-Mantel-Haenszel|Stratified by genotype||End of treatment||0.145|-0.033|0.219
72572963|NCT00536263|144673033|SUPERIORITY_OR_OTHER||Pairwise rate difference|0.126||||0.006|TWO_SIDED|95.0|0.037|0.216|||Cochran-Mantel-Haenszel|Stratified by genotype||End of treatment||0.216|0.037|0.006
72535289|NCT03557775|144599937|SUPERIORITY|||||||0.988||||||Result for time by group interaction effect. Threshold for statistical significance set at 0.05.|ANOVA|||Null hypothesis: there will be no significant time by group interaction effect for this variable.||||0.988
72535290|NCT03222570|144599968|SUPERIORITY||Estimated mean difference|-0.88||||0.76|TWO_SIDED|95.0|-6.56|4.7|||Regression, Linear||Mean difference estimated from fitting a linear regression model adjusting for baseline value of the measure.|||4.7|-6.56|0.76
72535291|NCT03222570|144599969|SUPERIORITY||Estimated mean difference|-2.52||||0.32|TWO_SIDED|95.0|-7.42|2.3|||Regression, Linear||Mean difference estimated from fitting a linear regression model adjusting for baseline value of the measure.|||2.3|-7.42|0.32
72535292|NCT05182840|144600001|OTHER||Mean Difference (Net)|-0.168||||0.0499|TWO_SIDED|95.0|-0.337|0.0|||MMRM||"Least Squares Mean of 3 mg BI 690517 - Least Squares Mean of Placebo to BI 690517."|The difference of adjusted means and 95 % confidence interval were estimated by restricted maximum likelihood-based mixed models for repeated measures ((REML)-based MMRM) which included the fixed effects of treatment at each visit, baseline (continuous) at each visit, and baseline, visit, treatment, background medication (empagliflozin or placebo matching empagliflozin) and randomisation stratum as main effects, as well as random effects of patient.||-0.000|-0.337|0.0499
72535293|NCT05182840|144600001|OTHER||Mean Difference (Net)|-0.486|||<|0.0001|TWO_SIDED|95.0|-0.66|-0.313|||MMRM||"Least Squares Mean of 10 mg BI 690517 - Least Squares Mean of Placebo to BI 690517."|The difference of adjusted means and 95 % confidence interval were estimated by restricted maximum likelihood-based mixed models for repeated measures ((REML)-based MMRM) which included the fixed effects of treatment at each visit, baseline (continuous) at each visit, and baseline, visit, treatment, background medication (empagliflozin or placebo matching empagliflozin) and randomisation stratum as main effects, as well as random effects of patient.||-0.313|-0.660|<.0001
72535294|NCT05182840|144600001|OTHER||Mean Difference (Net)|-0.421|||<|0.0001|TWO_SIDED|95.0|-0.596|-0.246|||MMRM||"Least Squares Mean of 20 mg BI 690517 - Least Squares Mean of Placebo to BI 690517."|The difference of adjusted means and 95 % confidence interval were estimated by restricted maximum likelihood-based mixed models for repeated measures ((REML)-based MMRM) which included the fixed effects of treatment at each visit, baseline (continuous) at each visit, and baseline, visit, treatment, background medication (empagliflozin or placebo matching empagliflozin) and randomisation stratum as main effects, as well as random effects of patient.||-0.246|-0.596|<.0001
72572964|NCT00536263|144673033|SUPERIORITY_OR_OTHER||Pairwise rate difference|-0.071|||||TWO_SIDED|90.0|-0.148|0.006||||||End of treatment||0.006|-0.148|
72572965|NCT00536263|144673033|SUPERIORITY_OR_OTHER||Pairwise rate difference|0.082||||0.067|TWO_SIDED|95.0|-0.004|0.168|||Cochran-Mantel-Haenszel|Stratified by genotype||24 weeks after EOT||0.168|-0.004|0.067
72572966|NCT00536263|144673033|SUPERIORITY_OR_OTHER||Pairwise rate difference|0.18|||<|0.001|TWO_SIDED|95.0|0.092|0.268|||Cochran-Mantel-Haenszel|Stratified by genotype||24 weeks after EOT||0.268|0.092|<0.001
72408322|NCT02047110|144325032|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.1|||||TWO_SIDED|90.0|-18.3|18.3|||||"The confidence interval for the difference in proportion between the treatment groups was obtained by the Clopper- Pearson method. Difference calculated as risankizumab 90 mg minus Placebo."|p-values are not presented as they were not meaningful; 3 treatment groups had only a single patient with partial remission.||18.3|-18.3|
72535295|NCT05182840|144600001|OTHER|Null hypothesis: The dose-response curve is flat across the 3 BI 690517 doses and the placebo.||||||0||||||P-value was rounded to four decimal places.|MCPMod Emax model fit|Emax model fit assumption: 80% of the maximum effect is achieved at 10 mg.||"A flat vs. non-flat dose-response relationship across the 3 doses of BI 690517 and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod).~MMRM estimates were used as input for the MCP-Mod. MMRM included the fixed effects of treatment at each visit, baseline (continuous) at each visit, and baseline, visit, treatment, background medication (empagliflozin or placebo matching empagliflozin) and randomisation stratum as main effects, as well as random effects of patient."||||0.0000
72535296|NCT05182840|144600001|OTHER|Null hypothesis: The dose-response curve is flat across the 3 BI 690517 doses and the placebo.||||||0||||||P-value was rounded to four decimal places.|MCPMod linear model fit|Linear model fit assumption: No assumption is needed.||"A flat vs. non-flat dose-response relationship across the 3 doses of BI 690517 and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod).~MMRM estimates were used as input for the MCP-Mod. MMRM included the fixed effects of treatment at each visit, baseline (continuous) at each visit, and baseline, visit, treatment, background medication (empagliflozin or placebo matching empagliflozin) and randomisation stratum as main effects, as well as random effects of patient."||||0.0000
72535297|NCT05182840|144600001|OTHER|Null hypothesis: The dose-response curve is flat across the 3 BI 690517 doses and the placebo.||||||0.0003|||||||MCPMod exponential model fit|Exponential model fit assumption: 15% of the maximum effect is achieved at 10 mg.||A flat vs. non-flat dose-response relationship across the 3 doses of BI 690517 and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod). MMRM estimates were used as input for the MCP-Mod. MMRM included the fixed effects of treatment at each visit, baseline (continuous) at each visit, and baseline, visit, treatment, background medication (empagliflozin or placebo matching empagliflozin) and randomisation stratum as main effects, as well as random effects of patient.||||0.0003
72535298|NCT05182840|144600002|OTHER||Median Difference (Net)|-15.5|||||TWO_SIDED|95.0|-28.6|0.0|||||"Median of 3 mg BI 690517 - Median of Placebo to BI 690517."|||-0.0|-28.6|
72535299|NCT05182840|144600002|OTHER||Median Difference (Net)|-38.5|||||TWO_SIDED|95.0|-48.3|-26.8|||||"Median of 10 mg BI 690517 - Median of Placebo to BI 690517."|||-26.8|-48.3|
72535300|NCT05182840|144600002|OTHER||Median Difference (Net)|-34.3|||||TWO_SIDED|95.0|-44.9|-21.8|||||"Median of 20 mg BI 690517 - Median of Placebo to BI 690517."|||-21.8|-44.9|
72535301|NCT05182840|144600003|OTHER||Mean Difference (Net)|-0.227||||0.0867|TWO_SIDED|95.0|-0.488|0.033|||MMRM||"Least Squares Mean of Treatment period: Placebo to empagliflozin 10 mg + 3 mg BI 690517 - Least Squares Mean of Treatment period: Placebo to empagliflozin 10 mg + Placebo to BI 690517."|The difference of adjusted means and 95 % confidence interval were estimated by restricted maximum likelihood-based mixed models for repeated measures ((REML)-based MMRM) which included the fixed effects of treatment at each visit, baseline (continuous) at each visit, and baseline, visit, treatment, background medication (empagliflozin or placebo matching empagliflozin) and randomisation stratum as main effects, as well as random effects of patient.||0.033|-0.488|0.0867
72535302|NCT05182840|144600003|OTHER||Mean Difference (Net)|-0.469||||0.0007|TWO_SIDED|95.0|-0.737|-0.201|||MMRM||"Least Squares Mean of Treatment period: Placebo to empagliflozin 10 mg + 10 mg BI 690517 - Least Squares Mean of Treatment period: Placebo to empagliflozin 10 mg + Placebo to BI 690517."|The difference of adjusted means and 95 % confidence interval were estimated by restricted maximum likelihood-based mixed models for repeated measures ((REML)-based MMRM) which included the fixed effects of treatment at each visit, baseline (continuous) at each visit, and baseline, visit, treatment, background medication (empagliflozin or placebo matching empagliflozin) and randomisation stratum as main effects, as well as random effects of patient.||-0.201|-0.737|0.0007
72535303|NCT05182840|144600003|OTHER||Mean Difference (Net)|-0.429||||0.0027|TWO_SIDED|95.0|-0.707|-0.151|||MMRM||"Least Squares Mean of Treatment period: Placebo to empagliflozin 10 mg + 20 mg BI 6905177 - Least Squares Mean of Treatment period: Placebo to empagliflozin 10 mg + Placebo to BI 690517."|The difference of adjusted means and 95 % confidence interval were estimated by restricted maximum likelihood-based mixed models for repeated measures ((REML)-based MMRM) which included the fixed effects of treatment at each visit, baseline (continuous) at each visit, and baseline, visit, treatment, background medication (empagliflozin or placebo matching empagliflozin) and randomisation stratum as main effects, as well as random effects of patient.||-0.151|-0.707|0.0027
72535304|NCT05182840|144600004|OTHER||Median Difference (Net)|-20.3|||||TWO_SIDED|95.0|-38.6|3.4|||||"Median of Treatment period: Placebo to empagliflozin 10 mg + 3 mg BI 690517 - median of Treatment period: Placebo to empagliflozin 10 mg + Placebo to BI 690517."|||3.4|-38.6|
72535305|NCT05182840|144600004|OTHER||Median Difference (Net)|-37.4|||||TWO_SIDED|95.0|-52.2|-18.2|||||"Median of Treatment period: Placebo to empagliflozin 10 mg + 10 mg BI 690517 - median of Treatment period: Placebo to empagliflozin 10 mg + Placebo to BI 690517"|||-18.2|-52.2|
72535306|NCT05182840|144600004|OTHER||Median Difference (Net)|-34.9|||||TWO_SIDED|95.0|-50.7|-14.0|||||"Median of Treatment period: Placebo to empagliflozin 10 mg + 20 mg BI 6905177 - median of Treatment period: Placebo to empagliflozin 10 mg + Placebo to BI 690517."|||-14.0|-50.7|
72535307|NCT05182840|144600005|OTHER||Mean Difference (Net)|-0.098||||0.3737|TWO_SIDED|95.0|-0.316|0.119|||MMRM||"Least Squares Mean of Treatment period: 10 mg empagliflozin + 3 mg BI 690517 - Least Squares Mean of Treatment period: 10 mg empagliflozin + Placebo to BI 690517."|The difference of adjusted means and 95 % confidence interval were estimated by restricted maximum likelihood-based mixed models for repeated measures ((REML)-based MMRM) which included the fixed effects of treatment at each visit, baseline (continuous) at each visit, and baseline, visit, treatment, background medication (empagliflozin or placebo matching empagliflozin) and randomisation stratum as main effects, as well as random effects of patient.||0.119|-0.316|0.3737
72572967|NCT00536263|144673033|SUPERIORITY_OR_OTHER||Pairwise rate difference|-0.098|||||TWO_SIDED|90.0|-0.174|-0.021||||||24 weeks after EOT||-0.021|-0.174|
72572968|NCT00536263|144673034|SUPERIORITY_OR_OTHER||Pairwise rate difference|0.001||||0.995|TWO_SIDED|95.0|-0.039|0.041|||Cochran-Mantel-Haenszel|Stratified by genotype||End of treatment||0.041|-0.039|0.995
72408323|NCT02047110|144325032|SUPERIORITY_OR_OTHER||Risk Difference (RD)|7.5|||||TWO_SIDED|90.0|-12.1|26.6|||||"The confidence interval for the difference in proportion between the treatment groups was obtained by the Clopper- Pearson method. Difference calculated as risankizumab 180 mg minus Placebo."|p-values are not presented as they were not meaningful; 3 treatment groups had only a single patient with partial remission.||26.6|-12.1|
72408324|NCT02047110|144325033|SUPERIORITY_OR_OTHER||Risk Difference (RD)|25.0||||0.0092|TWO_SIDED|90.0|5.5|43.1||The Suissa-Shuster unconditional exact test was used to test the difference in the proportion of patients achieving the endpoint at Week 12, between treatment groups.|Suissa-Shuster unconditional exact test||"The confidence interval for the difference in proportion between the treatment groups was obtained by the Clopper-Pearson method. Difference calculated as risankizumab 18 mg minus Placebo."|||43.1|5.5|0.0092
72535308|NCT05182840|144600005|OTHER||Mean Difference (Net)|-0.502|||<|0.0001|TWO_SIDED|95.0|-0.73|-0.275|||MMRM||"Least Squares Mean of Treatment period: 10 mg empagliflozin + 10 mg BI 690517 - Least Squares Mean of Treatment period: 10 mg empagliflozin + Placebo to BI 690517."|The difference of adjusted means and 95 % confidence interval were estimated by restricted maximum likelihood-based mixed models for repeated measures ((REML)-based MMRM) which included the fixed effects of treatment at each visit, baseline (continuous) at each visit, and baseline, visit, treatment, background medication (empagliflozin or placebo matching empagliflozin) and randomisation stratum as main effects, as well as random effects of patient.||-0.275|-0.730|<.0001
72535309|NCT05182840|144600005|OTHER||Mean Difference (Net)|-0.404||||0.0004|TWO_SIDED|95.0|-0.625|-0.184|||MMRM||"Least Squares Mean of Treatment period: 10 mg empagliflozin + 20 mg BI 690517 - Least Squares Mean of Treatment period: 10 mg empagliflozin + Placebo to BI 690517."|The difference of adjusted means and 95 % confidence interval were estimated by restricted maximum likelihood-based mixed models for repeated measures ((REML)-based MMRM) which included the fixed effects of treatment at each visit, baseline (continuous) at each visit, and baseline, visit, treatment, background medication (empagliflozin or placebo matching empagliflozin) and randomisation stratum as main effects, as well as random effects of patient.||-0.184|-0.625|0.0004
72535310|NCT05182840|144600006|OTHER||Median Difference (Net)|-9.4|||||TWO_SIDED|95.0|-27.1|12.7|||||"Median of Treatment period: 10 mg empagliflozin + 3 mg BI 690517 - median of Treatment period: 10 mg empagliflozin + Placebo to BI 690517."|||12.7|-27.1|
72535311|NCT05182840|144600006|OTHER||Median Difference (Net)|-39.5|||||TWO_SIDED|95.0|-51.8|-24.0|||||"Median of Treatment period: 10 mg empagliflozin + 10 mg BI 690517 - median of Treatment period: 10 mg empagliflozin + Placebo to BI 690517."|||-24.0|-51.8|
72535312|NCT05182840|144600006|OTHER||Median Difference (Net)|-33.2|||||TWO_SIDED|95.0|-46.5|-16.8|||||"Median of Treatment period: 10 mg empagliflozin + 20 mg BI 690517 - median of Treatment period: 10 mg empagliflozin + Placebo to BI 690517."|||-16.8|-46.5|
72572969|NCT00536263|144673034|SUPERIORITY_OR_OTHER||Pairwise rate difference|0.054||||0.031|TWO_SIDED|95.0|0.005|0.103|||Cochran-Mantel-Haenszel|Stratified by genotype||End of treatment||0.103|0.005|0.031
72572970|NCT00536263|144673034|SUPERIORITY_OR_OTHER||Pairwise rate difference|-0.053|||||TWO_SIDED|90.0|-0.094|-0.012||||||End of treatment||-0.012|-0.094|
72572971|NCT00536263|144673034|SUPERIORITY_OR_OTHER||Pairwise rate difference|0.024||||0.389|TWO_SIDED|95.0|-0.03|0.078|||Cochran-Mantel-Haenszel|Stratified by genotype||24 weeks after EOT||0.078|-0.030|0.389
72572972|NCT00536263|144673034|SUPERIORITY_OR_OTHER||Pairwise rate difference|0.121|||<|0.001|TWO_SIDED|95.0|0.058|0.184|||Cochran-Mantel-Haenszel|Stratified by genotype||24 weeks after EOT||0.184|0.058|<0.001
72572973|NCT00536263|144673034|SUPERIORITY_OR_OTHER||Pairwise rate difference|-0.097|||||TWO_SIDED|90.0|-0.152|-0.041||||||24 weeks after EOT||-0.041|-0.152|
72408325|NCT02047110|144325033|SUPERIORITY_OR_OTHER||Risk Difference (RD)|13.3||||0.1243|TWO_SIDED|90.0|-5.9|30.5||The Suissa-Shuster unconditional exact test was used to test the difference in the proportion of patients achieving the endpoint at Week 12, between treatment groups.|Suissa-Shuster unconditional exact test||"The confidence interval for the difference in proportion between the treatment groups was obtained by the Clopper- Pearson method. Difference calculated as risankizumab 90 mg minus Placebo."|||30.5|-5.9|0.1243
72572974|NCT00536263|144673035|SUPERIORITY_OR_OTHER||Pairwise rate difference|0.0||||0.991|TWO_SIDED|95.0|-0.012|0.012|||Cochran-Mantel-Haenszel|Stratified by genotype||End of treatment||0.012|-0.012|0.991
72535313|NCT05182840|144600007|OTHER||Odds Ratio (OR)|2.08||||0.0136|TWO_SIDED|95.0|1.16|3.72||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of 3 mg BI 690517 vs. Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||3.72|1.16|0.0136
72535314|NCT05182840|144600007|OTHER||Odds Ratio (OR)|7.02||||0|TWO_SIDED|95.0|3.94|12.49||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of 10 mg BI 690517 vs. Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||12.49|3.94|0.0000
72572975|NCT00536263|144673035|SUPERIORITY_OR_OTHER||Pairwise rate difference|0.013||||0.181|TWO_SIDED|95.0|-0.006|0.033|||Cochran-Mantel-Haenszel|Stratified by genotype||End of treatment||0.033|-0.006|0.181
72572976|NCT00536263|144673035|SUPERIORITY_OR_OTHER||Pairwise rate difference|-0.013|||||TWO_SIDED|90.0|-0.03|0.003||||||End of treatment||0.003|-0.030|
72572977|NCT00536263|144673035|SUPERIORITY_OR_OTHER||Pairwise rate difference|0.0||||0.971|TWO_SIDED|95.0|-0.012|0.012|||Cochran-Mantel-Haenszel|Stratified by genotype||24 weeks after EOT||0.012|-0.012|0.971
72572978|NCT00536263|144673035|SUPERIORITY_OR_OTHER||Pairwise rate difference|0.013||||0.179|TWO_SIDED|95.0|-0.006|0.033|||Cochran-Mantel-Haenszel|Stratified by genotype||24 weeks after EOT||0.033|-0.006|0.179
72572979|NCT00536263|144673035|SUPERIORITY_OR_OTHER||Pairwise rate difference|-0.013|||||TWO_SIDED|90.0|-0.03|0.003||||||24 weeks after EOT||0.003|-0.030|
72572980|NCT00536263|144673036|SUPERIORITY_OR_OTHER|||||||0.991|||||||Cochran-Mantel-Haenszel|"Stratified by genotype~Due to zero responses in the 2 arms, pairwise rate difference \& corresponding 95% confidence interval were not applicable."||End of treatment||||0.991
72572981|NCT00536263|144673036|SUPERIORITY_OR_OTHER||Pairwise rate difference|0.004||||0.322|TWO_SIDED|95.0|-0.004|0.013|||Cochran-Mantel-Haenszel|Stratified by genotype||End of treatment||0.013|-0.004|0.322
72408326|NCT02047110|144325033|SUPERIORITY_OR_OTHER||Risk Difference (RD)|12.5||||0.1198|TWO_SIDED|90.0|-7.1|31.4||The Suissa-Shuster unconditional exact test was used to test the difference in the proportion of patients achieving the endpoint at Week 12, between treatment groups|Suissa-Shuster unconditional exact test||"The confidence interval for the difference in proportion between the treatment groups was obtained by the Clopper- Pearson method. Difference calculated as risankizumab 180 mg minus Placebo."|||31.4|-7.1|0.1198
72408327|NCT02047110|144325034|SUPERIORITY_OR_OTHER||Median estimate by Hodges-Lehmann method|-0.4||||0.1241|TWO_SIDED|90.0|-1.0|0.2||One sided p-value from Wilcoxon rank-sum test|Wilcoxon rank-sum test||"The confidence interval for the difference in proportion between the treatment groups was obtained by the Moses method. Difference calculated as risankizumab 18 mg minus Placebo."|||0.2|-1.0|0.1241
72408328|NCT02047110|144325034|SUPERIORITY_OR_OTHER||Median estimate by Hodges-Lehmann method|0.3||||0.3033|TWO_SIDED|90.0|-0.5|1.0||One sided p-value from Wilcoxon rank-sum test|Wilcoxon rank-sum test||"The confidence interval for the difference in proportion between the treatment groups was obtained by the Moses method. Difference calculated as risankizumab 90 mg minus Placebo."|||1.0|-0.5|0.3033
72535315|NCT05182840|144600007|OTHER||Odds Ratio (OR)|5.48||||0|TWO_SIDED|95.0|3.09|9.71||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of 20 mg BI 690517 vs. Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||9.71|3.09|0.0000
72535316|NCT05182840|144600008|OTHER||Odds Ratio (OR)|2.15||||0.0111|TWO_SIDED|95.0|1.19|3.88||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of 3 mg BI 690517 vs. Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||3.88|1.19|0.0111
72535317|NCT05182840|144600008|OTHER||Odds Ratio (OR)|6.33||||0|TWO_SIDED|95.0|3.49|11.49||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of 10 mg BI 690517 vs. Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||11.49|3.49|0.0000
72535318|NCT05182840|144600008|OTHER||Odds Ratio (OR)|5.21||||0|TWO_SIDED|95.0|2.88|9.44||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of 20 mg BI 690517 vs. Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||9.44|2.88|0.0000
72535319|NCT05182840|144600009|OTHER||Odds Ratio (OR)|1.8||||0.0348|TWO_SIDED|95.0|1.04|3.09||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of 3 mg BI 690517 vs. Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||3.09|1.04|0.0348
72535320|NCT05182840|144600009|OTHER||Odds Ratio (OR)|4.12||||0|TWO_SIDED|95.0|2.4|7.08||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of 10 mg BI 690517 vs. Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||7.08|2.40|0.0000
72535321|NCT05182840|144600009|OTHER||Odds Ratio (OR)|5.02||||0|TWO_SIDED|95.0|2.91|8.67||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of 20 mg BI 690517 vs. Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||8.67|2.91|0.0000
72572982|NCT00536263|144673036|SUPERIORITY_OR_OTHER||Pairwise rate difference|-0.004|||||TWO_SIDED|90.0|-0.012|0.003||||||End of treatment||0.003|-0.012|
72572983|NCT00536263|144673036|SUPERIORITY_OR_OTHER|||||||0.991||95.0|||||Cochran-Mantel-Haenszel|"Stratified by genotype~Due to zero responses in the 2 arms, pairwise rate difference \& corresponding 95% confidence interval were not applicable."||24 weeks after EOT||||0.991
72572984|NCT00536263|144673036|SUPERIORITY_OR_OTHER||Pairwise rate difference|0.009||||0.157|TWO_SIDED|95.0|-0.003|0.021|||Cochran-Mantel-Haenszel|Stratified by genotype||24 weeks after EOT||0.021|-0.003|0.157
72572985|NCT00536263|144673036|SUPERIORITY_OR_OTHER||Pairwise rate difference|-0.009|||||TWO_SIDED|90.0|-0.019|0.001||||||24 weeks after EOT||0.001|-0.019|
72408329|NCT02047110|144325034|SUPERIORITY_OR_OTHER||Median estimate by Hodges-Lehmann method|-0.2||||0.3203|TWO_SIDED|90.0|-0.8|0.4||One sided p-value from Wilcoxon rank-sum test|Wilcoxon rank-sum test||"The confidence interval for the difference in proportion between the treatment groups was obtained by the Moses method. Difference calculated as risankizumab 180 mg minus Placebo."|||0.4|-0.8|0.3203
72572986|NCT00536263|144673037|SUPERIORITY_OR_OTHER|||||||0.014||95.0|||||t-test, 2 sided|comparison of post-treatment versus baseline values||||||0.014
72572987|NCT00536263|144673037|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|comparison of post-treatment versus baseline values||||||<0.001
72408330|NCT02047110|144325035|SUPERIORITY_OR_OTHER||Risk Difference (RD)|7.5||||0.2639|TWO_SIDED|90.0|-12.1|26.6||The Suissa-Shuster unconditional exact test was used to test the difference in the proportion of patients achieving the endpoint at Week 24, between treatment groups.|Suissa-Shuster unconditional exact test||"The confidence interval for the difference in proportion between the treatment groups was obtained by the Clopper-Pearson method. Difference calculated as risankizumab 18 mg minus Placebo."|||26.6|-12.1|0.2639
72626577|NCT01576783|144781970|OTHER|The reported p-value is for the comparison of the scores between groups (DHA+AA vs. Placebo) at the end of the trial.||||||0.22||||||Threshold for statistical significance (\<0.05).|Mixed Models Analysis|Continuous scores at the end of the trial were compared using a linear mixed model.||||||0.22
72626578|NCT01576783|144781971|OTHER|The reported p-value is for the comparison of the change in Nocturnal Sleep Duration between groups (DHA+AA vs. Placebo).||||||0.23||||||Threshold for statistical significance (\<0.05).|Mixed Models Analysis|||||||0.23
72626579|NCT01576783|144781971|OTHER|The reported p-value is for the comparison of the change in Daytime Sleep Duration between groups (DHA+AA vs. Placebo).||||||0.07||||||Threshold for statistical significance (\<0.05).|Mixed Models Analysis|||||||0.07
72535322|NCT05182840|144600010|OTHER||Odds Ratio (OR)|2.15||||0.0111|TWO_SIDED|95.0|1.19|3.88||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of 3 mg BI 690517 vs. Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||3.88|1.19|0.0111
72535323|NCT05182840|144600010|OTHER||Odds Ratio (OR)|6.33||||0|TWO_SIDED|95.0|3.49|11.49||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of 10 mg BI 690517 vs. Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||11.49|3.49|0.0000
72535324|NCT05182840|144600010|OTHER||Odds Ratio (OR)|5.21||||0|TWO_SIDED|95.0|2.88|9.44||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of 20 mg BI 690517 vs. Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||9.44|2.88|0.0000
72535325|NCT05182840|144600011|OTHER||Odds Ratio (OR)|2.44||||0.0419|TWO_SIDED|95.0|1.03|5.74||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of Treatment period: Placebo to empagliflozin 10 mg + 3 mg BI 690517 vs. Treatment period: Placebo to empagliflozin 10 mg + Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||5.74|1.03|0.0419
72535326|NCT05182840|144600011|OTHER||Odds Ratio (OR)|6.09||||0|TWO_SIDED|95.0|2.64|14.08||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of Treatment period: Placebo to empagliflozin 10 mg + 10 mg BI 690517 vs. Treatment period: Placebo to empagliflozin 10 mg + Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||14.08|2.64|0.0000
72572988|NCT00536263|144673037|SUPERIORITY_OR_OTHER|||||||0.01||95.0|||||t-test, 2 sided|comparison of post-treatment versus baseline values||||||0.010
72626580|NCT01576783|144781971|OTHER|The reported p-value is for the comparison of the change in Total Sleep Duration between groups (DHA+AA vs. Placebo).||||||0.06||||||Threshold for statistical significance (\<0.05).|Mixed Models Analysis|||||||0.06
72626581|NCT01576783|144781972|OTHER|The reported p-value is for the comparison of the scores between groups (DHA+AA vs. Placebo) at post-intervention follow-up (median of 8.3 months (IQR = 4.8) after trial completion and supplementation stopped).||||||0.51||||||Threshold for statistical significance (\<0.05).|Mixed Models Analysis|Continuous scores at the end of the trial were compared using a linear mixed model.||||||0.51
72572989|NCT00536263|144673037|SUPERIORITY_OR_OTHER||Pairwise rate difference|-0.2||||0.631|TWO_SIDED|95.0|-1.2|0.8|||ANCOVA|Treatment group and genotype were the fixed effects and baseline was the covariate.||||0.8|-1.2|0.631
72626582|NCT01576783|144781973|OTHER|The reported p-value is for the comparison of the scores between groups (DHA+AA vs. Placebo) at post-intervention follow-up (median of 8.3 months (IQR = 4.8) after trial completion and supplementation stopped).||||||0.09||||||Threshold for statistical significance (\<0.05).|Mixed Models Analysis|Linear mixed models compared continuous scores at follow-up between treatment groups. Model controlled for baseline scores.||||||0.09
72626583|NCT01576783|144781974|OTHER|The reported p-value is for the comparison of the scores between groups (DHA+AA vs. Placebo) at post-intervention follow-up (median of 8.3 months (IQR = 4.8) after trial completion and supplementation stopped).||||||0.29||||||Threshold for statistical significance (\<0.05).|Mixed Models Analysis|Linear mixed models compared continuous scores at follow-up between treatment groups. Model controlled for baseline scores.||||||0.29
72626584|NCT01576783|144781974|OTHER|The reported p-value is for the comparison of the scores between groups (DHA+AA vs. Placebo) at post-intervention follow-up (median of 8.3 months (IQR = 4.8) after trial completion and supplementation stopped).||||||0.11||||||Threshold for statistical significance (\<0.05).|Mixed Models Analysis|Linear mixed models compared continuous scores at follow-up between treatment groups. Model controlled for baseline scores.||||||0.11
72572990|NCT00536263|144673037|SUPERIORITY_OR_OTHER||Pairwise rate difference|-0.3||||0.617|TWO_SIDED|95.0|-1.4|0.8|||ANCOVA|Treatment group and genotype were the fixed effects and baseline was the covariate.||||0.8|-1.4|0.617
72572991|NCT00536263|144673037|SUPERIORITY_OR_OTHER||Pairwise rate difference|0.0|||||TWO_SIDED|95.0|-1.1|1.1||||||||1.1|-1.1|
72626585|NCT01576783|144781974|OTHER|The reported p-value is for the comparison of the scores between groups (DHA+AA vs. Placebo) at post-intervention follow-up (median of 8.3 months (IQR = 4.8) after trial completion and supplementation stopped).||||||0.23||||||Threshold for statistical significance (\<0.05).|Mixed Models Analysis|Linear mixed models compared continuous scores at follow-up between treatment groups.||||||0.23
72535327|NCT05182840|144600011|OTHER||Odds Ratio (OR)|6.13||||0|TWO_SIDED|95.0|2.64|14.25||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of Treatment period: Placebo to empagliflozin 10 mg + 20 mg BI 690517 vs. Treatment period: Placebo to empagliflozin 10 mg + Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||14.25|2.64|0.0000
72535328|NCT05182840|144600012|OTHER||Odds Ratio (OR)|2.88||||0.0195|TWO_SIDED|95.0|1.19|7.02||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of Treatment period: Placebo to empagliflozin 10 mg + 3 mg BI 690517 vs. Treatment period: Placebo to empagliflozin 10 mg + Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||7.02|1.19|0.0195
72535329|NCT05182840|144600012|OTHER||Odds Ratio (OR)|6.38||||0|TWO_SIDED|95.0|2.65|15.35||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of Treatment period: Placebo to empagliflozin 10 mg + 10 mg BI 690517 vs. Treatment period: Placebo to empagliflozin 10 mg + Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||15.35|2.65|0.0000
72535330|NCT05182840|144600012|OTHER||Odds Ratio (OR)|6.39||||0.0001|TWO_SIDED|95.0|2.6|15.67||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of Treatment period: Placebo to empagliflozin 10 mg + 20 mg BI 690517 vs. Treatment period: Placebo to empagliflozin 10 mg + Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||15.67|2.60|0.0001
72535331|NCT05182840|144600013|OTHER||Odds Ratio (OR)|2.03||||0.0767|TWO_SIDED|95.0|0.93|4.42||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of Treatment period: Placebo to empagliflozin 10 mg + 3 mg BI 690517 vs. Treatment period: Placebo to empagliflozin 10 mg + Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||4.42|0.93|0.0767
72408331|NCT02047110|144325035|SUPERIORITY_OR_OTHER||Risk Difference (RD)|8.1||||0.2691|TWO_SIDED|90.0|-10.9|25.7||The Suissa-Shuster unconditional exact test was used to test the difference in the proportion of patients achieving the endpoint at Week 24, between treatment groups.|Suissa-Shuster unconditional exact test||"The confidence interval for the difference in proportion between the treatment groups was obtained by the Clopper- Pearson method. Difference calculated as risankizumab 90 mg minus Placebo."|||25.7|-10.9|0.2691
72572992|NCT03118570|144673079|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.644||||||Analysis is based on a log transformed analysis of covariance (ANCOVA) model with change from baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||||||0.644
72572993|NCT03118570|144673079|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.485||||||Analysis is based on a log transformed ANCOVA model with change from baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||||||0.485
72572994|NCT03118570|144673079|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.404||||||Analysis is based on a log transformed ANCOVA model with change from baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||||||0.404
72572995|NCT03118570|144673080|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.006||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||||||0.006
72408332|NCT02047110|144325035|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-2.5||||0.4174|TWO_SIDED|90.0|-21.8|17.0||The Suissa-Shuster unconditional exact test was used to test the difference in the proportion of patients achieving the endpoint at Week 24, between treatment groups|Suissa-Shuster unconditional exact test||"The confidence interval for the difference in proportion between the treatment groups was obtained by the Clopper- Pearson method. Difference calculated as risankizumab 180 mg minus Placebo."|||17.0|-21.8|0.4174
72408333|NCT01959581|144325064|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||Repeated measures ANOVA||||<.05
72408334|NCT00079274|144325067|SUPERIORITY||Hazard Ratio (HR)|1.25||||0.15|TWO_SIDED|95.0|0.92|1.68|||Regression, Cox|HR and p-value reported from a multivariate Cox PH regression model, adjusted for number of nodes, histologic grade, and T stage.||||1.68|0.92|0.15
72408335|NCT00079274|144325068|SUPERIORITY||Hazard Ratio (HR)|1.27||||0.25|TWO_SIDED|95.0|0.85|1.92|||Regression, Cox|HR and p-value reported from a multivariate Cox PH regression model, adjusted for number of nodes, histologic grade, and T stage.||||1.92|0.85|0.25
72408336|NCT00079274|144325069|SUPERIORITY||||||<|0.001|||||||Chi-squared|two-sided chi-squared test||||||<0.001
72535332|NCT05182840|144600013|OTHER||Odds Ratio (OR)|4.11||||0.0003|TWO_SIDED|95.0|1.89|8.91||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of Treatment period: Placebo to empagliflozin 10 mg + 10 mg BI 690517 vs. Treatment period: Placebo to empagliflozin 10 mg + Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||8.91|1.89|0.0003
72535333|NCT05182840|144600013|OTHER||Odds Ratio (OR)|4.69||||0.0001|TWO_SIDED|95.0|2.15|10.24||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of Treatment period: Placebo to empagliflozin 10 mg + 20 mg BI 690517 vs. Treatment period: Placebo to empagliflozin 10 mg + Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||10.24|2.15|0.0001
72535334|NCT05182840|144600014|OTHER||Odds Ratio (OR)|2.88||||0.0195|TWO_SIDED|95.0|1.19|7.02||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of Treatment period: Placebo to empagliflozin 10 mg + 3 mg BI 690517 vs. Treatment period: Placebo to empagliflozin 10 mg + Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||7.02|1.19|0.0195
72535335|NCT05182840|144600014|OTHER||Odds Ratio (OR)|6.38||||0|TWO_SIDED|95.0|2.65|15.35||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of Treatment period: Placebo to empagliflozin 10 mg + 10 mg BI 690517 vs. Treatment period: Placebo to empagliflozin 10 mg + Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||15.35|2.65|0.0000
72408337|NCT00079274|144325070|SUPERIORITY||||||<|0.001|||||||Chi-squared|Two-sided chi-squared test||||||<0.001
72408338|NCT04542070|144325072|NON_INFERIORITY|Non-inferiority concluded if the upper limit of a two-sided 95% confidence interval for the difference in percentage of participants with HIV-1 RNA ≥ 50 c/mL at Month 12 (OLI and BIK)/Month 11 (D2I) between the two treatment arms (Q2M - BIK) is less than 4%.|Difference in percentage|0.9|||||TWO_SIDED|95.0|-0.5|2.2|||||Difference in percentage = percentage of Q2M - percentage of BIK|||2.2|-0.5|
72408339|NCT04542070|144325072|NON_INFERIORITY|Non-inferiority concluded if the upper limit of a two-sided 95% confidence interval for the difference in percentage of participants with HIV-1 RNA ≥ 50 c/mL at Month 12 (OLI and BIK)/Month 11 (D2I) between the two treatment arms (Q2M - BIK) is less than 4%.|Adjusted difference in percentage|0.9|||||TWO_SIDED|95.0|-0.5|2.2|||||Adjusted difference in percentage = percentage of Q2M - percentage of BIK. Based on cochran-mantel haenszel stratified analysis was adjusted for the baseline stratification factors gender at birth and baseline BMI.|||2.2|-0.5|
72408340|NCT04542070|144325073|NON_INFERIORITY|Non-inferiority concluded if the upper limit of a two-sided 95% confidence interval for the difference in percentage of participants with HIV-1 RNA ≥ 50 c/mL at Month 12 (OLI and BIK)/Month 11 (D2I) between the two treatment arms (Q2M - BIK) is less than 4%.|Difference in percentage|0.7|||||TWO_SIDED|95.0|-0.6|2.0|||||Difference in percentage = percentage of Q2M - percentage of BIK|||2.0|-0.6|
72408341|NCT04542070|144325073|NON_INFERIORITY|Non-inferiority concluded if the upper limit of a two-sided 95% confidence interval for the difference in percentage of participants with HIV-1 RNA ≥ 50 c/mL at Month 12 (OLI and BIK)/Month 11 (D2I) between the two treatment arms (Q2M - BIK) is less than 4%.|Adjusted difference in percentage|0.7|||||TWO_SIDED|95.0|-0.7|2.0|||||Adjusted difference in percentage = percentage of Q2M - percentage of BIK. Based on cochran-mantel haenszel stratified analysis was adjusted for the baseline stratification factors gender at birth and baseline BMI.|||2.0|-0.7|
72408342|NCT00550836|144325105|SUPERIORITY|||||||0.36|||||||Log Rank|||It was calculated that 39 participants randomized in a 1:1 fashion between the 2 arms would have 80% to detect a difference in median survival of 6 vs. 9.7 months for GE vs. PGE respectively with a minimum follow up of 6 months. Sample size was determined using a 1-sided log-rank test at alpha=0.20.||||0.36
72408343|NCT00550836|144325106|OTHER|||||||1|||||||Fisher Exact|||||||1.0
72535336|NCT05182840|144600014|OTHER||Odds Ratio (OR)|6.39||||0.0001|TWO_SIDED|95.0|2.6|15.67||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of Treatment period: Placebo to empagliflozin 10 mg + 20 mg BI 690517 vs. Treatment period: Placebo to empagliflozin 10 mg + Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||15.67|2.60|0.0001
72535337|NCT05182840|144600015|OTHER||Odds Ratio (OR)|1.82||||0.1398|TWO_SIDED|95.0|0.82|4.04||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of Treatment period: 10 mg empagliflozin + 3 mg BI 690517 vs. Treatment period: 10 mg empagliflozin + Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||4.04|0.82|0.1398
72535338|NCT05182840|144600015|OTHER||Odds Ratio (OR)|8.42||||0|TWO_SIDED|95.0|3.73|19.02||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of Treatment period: 10 mg empagliflozin + 10 mg BI 690517 vs. Treatment period: 10 mg empagliflozin + Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||19.02|3.73|0.0000
72535339|NCT05182840|144600015|OTHER|P-value was rounded to four decimal places.|Odds Ratio (OR)|4.98||||0.0001|TWO_SIDED|95.0|2.28|10.9|||Regression, Logistic||"Odds ratio of Treatment period: 10 mg empagliflozin + 20 mg BI 690517 vs. Treatment period: 10 mg empagliflozin + Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||10.90|2.28|0.0001
72535340|NCT05182840|144600016|OTHER||Odds Ratio (OR)|1.71||||0.1884|TWO_SIDED|95.0|0.77|3.79||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of Treatment period: 10 mg empagliflozin + 3 mg BI 690517 vs. Treatment period: 10 mg empagliflozin + Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||3.79|0.77|0.1884
72535341|NCT05182840|144600016|OTHER||Odds Ratio (OR)|6.8||||0|TWO_SIDED|95.0|2.94|15.72||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of Treatment period: 10 mg empagliflozin + 10 mg BI 690517 vs. Treatment period: 10 mg empagliflozin + Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||15.72|2.94|0.0000
72535342|NCT05182840|144600016|OTHER||Odds Ratio (OR)|4.46||||0.0003|TWO_SIDED|95.0|2.0|9.94||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of Treatment period: 10 mg empagliflozin + 20 mg BI 690517 vs. Treatment period: 10 mg empagliflozin + Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||9.94|2.00|0.0003
72572996|NCT03118570|144673080|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.19||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||||||0.190
72572997|NCT03118570|144673080|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.704||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||||||0.704
72572998|NCT03118570|144673081|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.011||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||||||0.011
72408344|NCT00550836|144325107|SUPERIORITY|||||||0.419|||||||Log Rank|||||||0.419
72408345|NCT00550836|144325108|OTHER|||||||0.36|||||||Log Rank|||||||0.36
72408346|NCT02144675|144325113|OTHER||||||<|0.05|||||||Regression, Cox|||||||<.05
72408347|NCT01458171|144325148|SUPERIORITY_OR_OTHER||Annualized Rate|0.0|||||ONE_SIDED|99.0||0.45||||||||0.450||
72408348|NCT01458171|144325148|SUPERIORITY_OR_OTHER||Annualized Rate|0.0|||||ONE_SIDED|99.0||0.523||||||||0.523||
72408349|NCT01696032|144325155|SUPERIORITY|||||||0.0654|||||||Log Rank|||||||0.0654
72535343|NCT05182840|144600017|OTHER||Odds Ratio (OR)|1.62||||0.214|TWO_SIDED|95.0|0.76|3.46||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of Treatment period: 10 mg empagliflozin + 3 mg BI 690517 vs. Treatment period: 10 mg empagliflozin + Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||3.46|0.76|0.2140
72535344|NCT05182840|144600017|OTHER||Odds Ratio (OR)|4.13||||0.0003|TWO_SIDED|95.0|1.93|8.85||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of Treatment period: 10 mg empagliflozin + 10 mg BI 690517 vs. Treatment period: 10 mg empagliflozin + Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||8.85|1.93|0.0003
72535345|NCT05182840|144600017|OTHER||Odds Ratio (OR)|5.43||||0|TWO_SIDED|95.0|2.52|11.71||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of Treatment period: 10 mg empagliflozin + 20 mg BI 690517 vs. Treatment period: 10 mg empagliflozin + Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||11.71|2.52|0.0000
72535346|NCT05182840|144600018|OTHER||Odds Ratio (OR)|1.71||||0.1884|TWO_SIDED|95.0|0.77|3.79||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of Treatment period: 10 mg empagliflozin + 3 mg BI 690517 vs. Treatment period: 10 mg empagliflozin + Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||3.79|0.77|0.1884
72535347|NCT05182840|144600018|OTHER||Odds Ratio (OR)|6.8||||0|TWO_SIDED|95.0|2.94|15.72||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of Treatment period: 10 mg empagliflozin + 10 mg BI 690517 vs. Treatment period: 10 mg empagliflozin + Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||15.72|2.94|0.0000
72535348|NCT05182840|144600018|OTHER||Odds Ratio (OR)|4.46||||0.0003|TWO_SIDED|95.0|2.0|9.94||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of Treatment period: 10 mg empagliflozin + 20 mg BI 690517 vs. Treatment period: 10 mg empagliflozin + Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||9.94|2.00|0.0003
72535349|NCT05182840|144600019|OTHER||Odds Ratio (OR)|2.18||||0.0024|TWO_SIDED|95.0|1.32|3.61||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of 3 mg BI 690517 vs. Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||3.61|1.32|0.0024
72535350|NCT05182840|144600019|OTHER||Odds Ratio (OR)|4.05||||0|TWO_SIDED|95.0|2.39|6.86||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of 10 mg BI 690517 vs. Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||6.86|2.39|0.0000
72535351|NCT05182840|144600019|OTHER||Odds Ratio (OR)|3.87||||0|TWO_SIDED|95.0|2.29|6.55||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of 20 mg BI 690517 vs. Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||6.55|2.29|0.0000
72535352|NCT05182840|144600020|OTHER||Odds Ratio (OR)|2.26||||0.0019|TWO_SIDED|95.0|1.35|3.77||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of 3 mg BI 690517 vs. Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||3.77|1.35|0.0019
72535353|NCT05182840|144600020|OTHER||Odds Ratio (OR)|3.81||||0|TWO_SIDED|95.0|2.2|6.59||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of 10 mg BI 690517 vs. Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||6.59|2.20|0.0000
72535354|NCT05182840|144600020|OTHER||Odds Ratio (OR)|3.67||||0|TWO_SIDED|95.0|2.12|6.35||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of 20 mg BI 690517 vs. Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||6.35|2.12|0.0000
72535355|NCT05182840|144600021|OTHER||Odds Ratio (OR)|1.67||||0.0418|TWO_SIDED|95.0|1.02|2.74||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of 3 mg BI 690517 vs. Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||2.74|1.02|0.0418
72535356|NCT05182840|144600021|OTHER||Odds Ratio (OR)|3.91||||0|TWO_SIDED|95.0|2.3|6.65||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of 10 mg BI 690517 vs. Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||6.65|2.30|0.0000
72535357|NCT05182840|144600021|OTHER||Odds Ratio (OR)|3.58||||0|TWO_SIDED|95.0|2.11|6.05||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of 20 mg BI 690517 vs. Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||6.05|2.11|0.0000
72535358|NCT05182840|144600022|OTHER||Odds Ratio (OR)|2.26||||0.0019|TWO_SIDED|95.0|1.35|3.77||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of 3 mg BI 690517 vs. Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||3.77|1.35|0.0019
72535359|NCT05182840|144600022|OTHER||Odds Ratio (OR)|3.81||||0|TWO_SIDED|95.0|2.2|6.59||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of 10 mg BI 690517 vs. Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||6.59|2.20|0.0000
72535360|NCT05182840|144600022|OTHER||Odds Ratio (OR)|3.67||||0|TWO_SIDED|95.0|2.12|6.35||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of 20 mg BI 690517 vs. Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||6.35|2.12|0.0000
72535361|NCT05182840|144600023|OTHER||Odds Ratio (OR)|2.2||||0.0285|TWO_SIDED|95.0|1.09|4.45||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of Treatment period: Placebo to empagliflozin 10 mg + 3 mg BI 690517 vs. Treatment period: Placebo to empagliflozin 10 mg + Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||4.45|1.09|0.0285
72535362|NCT05182840|144600023|OTHER||Odds Ratio (OR)|2.9||||0.0038|TWO_SIDED|95.0|1.41|5.96||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of Treatment period: Placebo to empagliflozin 10 mg + 10 mg BI 690517 vs. Treatment period: Placebo to empagliflozin 10 mg + Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||5.96|1.41|0.0038
72535363|NCT05182840|144600023|OTHER||Odds Ratio (OR)|4.15||||0.0002|TWO_SIDED|95.0|1.97|8.72||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of Treatment period: Placebo to empagliflozin 10 mg + 20 mg BI 690517 vs. Treatment period: Placebo to empagliflozin 10 mg + Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||8.72|1.97|0.0002
72535364|NCT05182840|144600024|OTHER||Odds Ratio (OR)|2.56||||0.0116|TWO_SIDED|95.0|1.23|5.31||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of Treatment period: Placebo to empagliflozin 10 mg + 3 mg BI 690517 vs. Treatment period: Placebo to empagliflozin 10 mg + Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||5.31|1.23|0.0116
72535365|NCT05182840|144600024|OTHER||Odds Ratio (OR)|3.08||||0.0032|TWO_SIDED|95.0|1.46|6.52||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of Treatment period: Placebo to empagliflozin 10 mg + 10 mg BI 690517 vs. Treatment period: Placebo to empagliflozin 10 mg + Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||6.52|1.46|0.0032
72572999|NCT03118570|144673081|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.047||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||||||0.047
72535366|NCT05182840|144600024|OTHER||Odds Ratio (OR)|4.07||||0.0004|TWO_SIDED|95.0|1.86|8.91||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of Treatment period: Placebo to empagliflozin 10 mg + 20 mg BI 690517 vs. Treatment period: Placebo to empagliflozin 10 mg + Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||8.91|1.86|0.0004
72535367|NCT05182840|144600025|OTHER||Odds Ratio (OR)|1.34||||0.4092|TWO_SIDED|95.0|0.67|2.69||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of Treatment period: Placebo to empagliflozin 10 mg + 3 mg BI 690517 vs. Treatment period: Placebo to empagliflozin 10 mg + Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||2.69|0.67|0.4092
72535368|NCT05182840|144600025|OTHER||Odds Ratio (OR)|3.66||||0.0005|TWO_SIDED|95.0|1.77|7.58||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of Treatment period: Placebo to empagliflozin 10 mg + 10 mg BI 690517 vs. Treatment period: Placebo to empagliflozin 10 mg + Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||7.58|1.77|0.0005
72535369|NCT05182840|144600025|OTHER||Odds Ratio (OR)|4.04||||0.0002|TWO_SIDED|95.0|1.92|8.49||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of Treatment period: Placebo to empagliflozin 10 mg + 20 mg BI 690517 vs. Treatment period: Placebo to empagliflozin 10 mg + Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||8.49|1.92|0.0002
72535370|NCT05182840|144600026|OTHER||Odds Ratio (OR)|2.16||||0.0348|TWO_SIDED|95.0|1.06|4.43||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of Treatment period: 10 mg empagliflozin + 3 mg BI 690517 vs. Treatment period: 10 mg empagliflozin + Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||4.43|1.06|0.0348
72535371|NCT05182840|144600026|OTHER||Odds Ratio (OR)|6.08||||0|TWO_SIDED|95.0|2.73|13.57||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of Treatment period: 10 mg empagliflozin + 10 mg BI 690517 vs. Treatment period: 10 mg empagliflozin + Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||13.57|2.73|0.0000
72535372|NCT05182840|144600026|OTHER||Odds Ratio (OR)|3.58||||0.0007|TWO_SIDED|95.0|1.71|7.52||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of Treatment period: 10 mg empagliflozin + 20 mg BI 690517 vs. Treatment period: 10 mg empagliflozin + Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||7.52|1.71|0.0007
72535373|NCT05182840|144600027|OTHER||Odds Ratio (OR)|2.01||||0.0578|TWO_SIDED|95.0|0.98|4.14||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of Treatment period: 10 mg empagliflozin + 3 mg BI 690517 vs. Treatment period: 10 mg empagliflozin + Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||4.14|0.98|0.0578
72535374|NCT05182840|144600027|OTHER||Odds Ratio (OR)|5.12||||0.0001|TWO_SIDED|95.0|2.23|11.78||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of Treatment period: 10 mg empagliflozin + 10 mg BI 690517 vs. Treatment period: 10 mg empagliflozin + Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||11.78|2.23|0.0001
72535375|NCT05182840|144600027|OTHER||Odds Ratio (OR)|3.32||||0.0022|TWO_SIDED|95.0|1.54|7.16||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of Treatment period: 10 mg empagliflozin + 20 mg BI 690517 vs. Treatment period: 10 mg empagliflozin + Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||7.16|1.54|0.0022
72573000|NCT03118570|144673081|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.756||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||||||0.756
72573001|NCT03118570|144673082|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.329||||||Analysis is based on a log transformed ANCOVA model with change from baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 6||||0.329
72573002|NCT03118570|144673082|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.953||||||Analysis is based on a log transformed ANCOVA model with change from baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 6||||0.953
72573003|NCT03118570|144673082|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.795||||||Analysis is based on a log transformed ANCOVA model with change from baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 6||||0.795
72573004|NCT03118570|144673082|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.644||||||Analysis is based on a log transformed ANCOVA model with change from baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 12||||0.644
72573005|NCT03118570|144673082|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.485||||||Analysis is based on a log transformed ANCOVA model with change from baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 12||||0.485
72573006|NCT03118570|144673082|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.404||||||Analysis is based on a log transformed ANCOVA model with change from baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 12||||0.404
72573007|NCT03118570|144673082|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.827||||||Analysis is based on a log transformed ANCOVA model with change from baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 18||||0.827
72573008|NCT03118570|144673082|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.459||||||Analysis is based on a log transformed ANCOVA model with change from baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 18||||0.459
72573009|NCT03118570|144673082|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.022||||||Analysis is based on a log transformed ANCOVA model with change from baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 18||||0.022
72573010|NCT03118570|144673082|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.821||||||Analysis is based on a log transformed ANCOVA model with change from baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 24||||0.821
72573011|NCT03118570|144673082|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.911||||||Analysis is based on a log transformed ANCOVA model with change from baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 24||||0.911
72573012|NCT03118570|144673082|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.152||||||Analysis is based on a log transformed ANCOVA model with change from baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 24||||0.152
72573013|NCT03118570|144673082|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.668||||||Analysis is based on a log transformed ANCOVA model with change from baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 6||||0.668
72573014|NCT03118570|144673082|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.109||||||Analysis is based on a log transformed ANCOVA model with change from baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 6||||0.109
72573015|NCT03118570|144673082|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.358||||||Analysis is based on a log transformed ANCOVA model with change from baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 6||||0.358
72573016|NCT03118570|144673082|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.742||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 12||||0.742
72573017|NCT03118570|144673082|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.567||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 12||||0.567
72573018|NCT03118570|144673082|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.43||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 12||||0.430
72573019|NCT03118570|144673082|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.634||||||Analysis is based on a log transformed ANCOVA model with change from baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 18||||0.634
72573020|NCT03118570|144673082|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.146||||||Analysis is based on a log transformed ANCOVA model with change from baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 18||||0.146
72408350|NCT01192152|144325173|NON_INFERIORITY_OR_EQUIVALENCE|BE was concluded if the 90% CIs for the test-to-reference ratios of geometric means were entirely contained within 0.800 to 1.250 for both Cmax and AUC0-inf of saxagliptin.|Ratio of geometric least squares means|1.045|||||TWO_SIDED|90.0|1.025|1.065|||||Ratio = Treatment B/Treatment A. Geometric least squares means values presented in other statistical analysis entries.|If there was no difference between the bioavailabilities of saxagliptin from the FDC tablet versus saxagliptin from coadministration of a 5-mg saxagliptin tablet plus two 500-mg metformin XR tablets under fed conditions, then 24 subjects would have provided 99% power to conclude bioequivalence (BE) with respect to Cmax and AUC0-inf. If there was a 5% difference, then 24 subjects would have provided 94% and 99% power to conclude BE with respect to Cmax and AUC0-inf.||1.065|1.025|
72408351|NCT01192152|144325173|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean (ng*hr/mL)|103.05||||||95.0||||||||Geometric least squares means for Treatment B||||
72408352|NCT01192152|144325173|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean (ng*hr/mL)|98.61||||||95.0||||||||Geometric least squares means for Treatment A||||
72408353|NCT01192152|144325174|SUPERIORITY_OR_OTHER||Ratio of geometric least squares means|1.035|||||TWO_SIDED|90.0|1.009|1.062|||||Ratio = Treatment B/Treatment A. Geometric least squares means values are presented in other statistical analysis entries.|||1.062|1.009|
72408354|NCT01192152|144325174|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean (ng*hr/mL)|101.16||||||95.0||||||||Geometric least squares means for Treatment B||||
72535376|NCT05182840|144600028|OTHER||Odds Ratio (OR)|2.17||||0.0342|TWO_SIDED|95.0|1.06|4.44||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of Treatment period: 10 mg empagliflozin + 3 mg BI 690517 vs. Treatment period: 10 mg empagliflozin + Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||4.44|1.06|0.0342
72535377|NCT05182840|144600028|OTHER||Odds Ratio (OR)|4.23||||0.0003|TWO_SIDED|95.0|1.93|9.24||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of Treatment period: 10 mg empagliflozin + 10 mg BI 690517 vs. Treatment period: 10 mg empagliflozin + Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||9.24|1.93|0.0003
72535378|NCT05182840|144600028|OTHER||Odds Ratio (OR)|3.19||||0.0023|TWO_SIDED|95.0|1.52|6.73||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of Treatment period: 10 mg empagliflozin + 20 mg BI 690517 vs. Treatment period: 10 mg empagliflozin + Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||6.73|1.52|0.0023
72535379|NCT05182840|144600029|OTHER||Odds Ratio (OR)|2.56||||0.0116|TWO_SIDED|95.0|1.23|5.31||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of Treatment period: Placebo to empagliflozin 10 mg + 3 mg BI 690517 vs. Treatment period: Placebo to empagliflozin 10 mg + Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||5.31|1.23|0.0116
72535380|NCT05182840|144600029|OTHER||Odds Ratio (OR)|3.08||||0.0032|TWO_SIDED|95.0|1.46|6.52||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of Treatment period: Placebo to empagliflozin 10 mg + 10 mg BI 690517 vs. Treatment period: Placebo to empagliflozin 10 mg + Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||6.52|1.46|0.0032
72408355|NCT01192152|144325174|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean (ng*hr/mL)|97.72||||||95.0||||||||Geometric least squares means for Treatment A||||
72408356|NCT01192152|144325176|NON_INFERIORITY_OR_EQUIVALENCE|BE was concluded if the 90% CIs for the test-to-reference ratios of geometric means were entirely contained within 0.800 to 1.250 for both Cmax and AUC0-inf of saxagliptin.|Ratio of geometric least squares mean|0.999|||||TWO_SIDED|90.0|0.948|1.053|||||Ratio = Treatment B/Treatment A. Geometric least squares means values are presented in other statistical analysis entries.|If there was no difference between the bioavailabilities of saxagliptin from the FDC tablet versus saxagliptin from coadministration of a 5-mg saxagliptin tablet plus two 500-mg metformin XR tablets under fed conditions, then 24 subjects would have provided 99% power to conclude bioequivalence (BE) with respect to Cmax and AUC0-inf. If there was a 5% difference, then 24 subjects would have provided 94% and 99% power to conclude BE with respect to Cmax and AUC0-inf.||1.053|0.948|
72408357|NCT01192152|144325176|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean (ng*hr/mL)|24.85||||||95.0||||||||Geometric least squares means for Treatment B||||
72408358|NCT01192152|144325176|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean (ng*hr/mL)|24.88||||||95.0||||||||Geometric least squares means for Treatment A||||
72408359|NCT01192152|144325193|NON_INFERIORITY_OR_EQUIVALENCE|BE was concluded if the 90% CIs for the test-to-reference ratios of geometric means were entirely contained within 0.800 to 1.250 for both Cmax and AUC0-inf of metformin.|ratio of geometric least squares means|0.894|||||TWO_SIDED|90.0|0.833|0.959|||||Ratio = Treatment B/Treatment A. Geometric least squares means values are presented in other statistical analysis entries.|If there was no difference between the bioavailabilities of metformin from the FDC tablet versus metformin from coadministration of a 5-mg saxagliptin tablet plus two 500-mg metformin XR tablets under fed conditions, then 24 subjects would have provided 99% power to conclude BE with respect to Cmax and AUC0-inf. If there was a 5% difference, then 24 subjects would have provided at least 99% power to conclude BE with respect to Cmax and AUC0-inf.||0.959|0.833|
72408360|NCT01192152|144325193|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean (ng*hr/mL)|8713.4||||||95.0||||||||Geometric least squares mean for Treatment B||||
72408361|NCT01192152|144325193|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean (ng*hr/mL)|9746.3||||||95.0||||||||Geometric least squares mean for Treatment A||||
72535381|NCT05182840|144600029|OTHER||Odds Ratio (OR)|4.07||||0.0004|TWO_SIDED|95.0|1.86|8.91||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of Treatment period: Placebo to empagliflozin 10 mg + 20 mg BI 690517 vs. Treatment period: Placebo to empagliflozin 10 mg + Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||8.91|1.86|0.0004
72535382|NCT05182840|144600030|OTHER||Odds Ratio (OR)|2.01||||0.0578|TWO_SIDED|95.0|0.98|4.14||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of Treatment period: 10 mg empagliflozin + 3 mg BI 690517 vs. Treatment period: 10 mg empagliflozin + Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||4.14|0.98|0.0578
72535383|NCT05182840|144600030|OTHER||Odds Ratio (OR)|5.12||||0.0001|TWO_SIDED|95.0|2.23|11.78||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of Treatment period: 10 mg empagliflozin + 10 mg BI 690517 vs. Treatment period: 10 mg empagliflozin + Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||11.78|2.23|0.0001
72535384|NCT05182840|144600030|OTHER||Odds Ratio (OR)|3.32||||0.0022|TWO_SIDED|95.0|1.54|7.16||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of Treatment period: 10 mg empagliflozin + 20 mg BI 690517 vs. Treatment period: 10 mg empagliflozin + Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||7.16|1.54|0.0022
72535385|NCT00863265|144600033|EQUIVALENCE||Mean Difference (Final Values)|289.0||||0.01|TWO_SIDED||||||ANOVA||The estimation parameter is the difference between the placebo group and the ezetimibe group.|Phytosterol Diet compared to Ezetimibe||||0.01
72535386|NCT00863265|144600033|EQUIVALENCE|The hypothesis is that groups are equal.|Mean Difference (Final Values)|457.0|||<|0.01|TWO_SIDED||||||ANOVA|||Placebo vs. Ezetimibe Plus Phytosterols||||<0.01
72535387|NCT00863265|144600033|EQUIVALENCE|The hypothesis is that groups are equal|Mean Difference (Final Values)|168.0|||<|0.01|TWO_SIDED||||||ANOVA|||Ezetimibe vs. Ezetimibe Plus Phytosterols||||<0.01
72535388|NCT00863265|144600034|EQUIVALENCE|Not applicable in this study.|Mean Difference (Final Values)|22.8|||<|0.01|TWO_SIDED|||||Adjusted for multiple comparisons.|ANOVA|||The hypothesis is that groups are equal||||<0.01
72535389|NCT00863265|144600034|EQUIVALENCE||Mean Difference (Final Values)|36.4|||<|0.01|TWO_SIDED|||||Adjusted for multiple comparisons.|ANOVA|||Placebo vs. Ezetimibe Plus Phytosterols||||<0.01
72535390|NCT00863265|144600034|EQUIVALENCE||Mean Difference (Final Values)|13.6|||<|0.01|TWO_SIDED|||||Adjusted for multiple comparisons.|ANOVA|||The hypothesis is that groups are equal.||||<0.01
72535391|NCT00863265|144600035|EQUIVALENCE||Mean Difference (Final Values)|21.0|||<|0.01|TWO_SIDED||||||ANOVA|||The hypothesis is that groups are equal.||||<0.01
72535392|NCT00863265|144600035|EQUIVALENCE||Mean Difference (Final Values)|28.0|||<|0.01|TWO_SIDED|||||Adjusted for multiple comparisons.|ANOVA|||The hypothesis is that all groups are equal||||<0.01
72408362|NCT01192152|144325194|SUPERIORITY_OR_OTHER||ratio of geometric least squares means|0.906|||||TWO_SIDED|90.0|0.848|0.968|||||Ratio = Treatment B/Treatment A. Geometric least squares means values are presented in other statistical analysis entries.|||0.968|0.848|
72408363|NCT01192152|144325194|SUPERIORITY_OR_OTHER||Geometric least squares mean (ng*hr/mL)|8377.8||||||95.0||||||||Geometric least squares means for Treatment B||||
72535393|NCT00863265|144600035|EQUIVALENCE||Mean Difference (Final Values)|7.0|||<|0.05|TWO_SIDED|||||Adjusted for multiple comparisons.|ANOVA|||The hypothesis is that groups are equal.||||<0.05
72535394|NCT02268214|144600036|SUPERIORITY||Mean Difference (Final Values)|-0.42|STANDARD_ERROR_OF_MEAN|0.0697|<|0.0001|TWO_SIDED|95.0|-0.56|-0.28|||RMM|Repeated Measures Model||||-0.28|-0.56|<0.0001
72573021|NCT03118570|144673082|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.521||||||Analysis is based on a log transformed ANCOVA model with change from baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 18||||0.521
72573022|NCT03118570|144673082|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.991||||||Analysis is based on a log transformed ANCOVA model with change from baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 24||||0.991
72626586|NCT01576783|144781974|OTHER|The reported p-value is for the comparison of the scores between groups (DHA+AA vs. Placebo) at post-intervention follow-up (median of 8.3 months (IQR = 4.8) after trial completion and supplementation stopped).||||||0.29||||||Threshold for statistical significance (\<0.05).|Mixed Models Analysis|Linear mixed models compared continuous scores at follow-up between treatment groups.||||||0.29
72626587|NCT01576783|144781974|OTHER|The reported p-value is for the comparison of the scores between groups (DHA+AA vs. Placebo) at post-intervention follow-up (median of 8.3 months (IQR = 4.8) after trial completion and supplementation stopped).||||||0.06||||||Threshold for statistical significance (\<0.05).|Mixed Models Analysis|Linear mixed models compared continuous scores at follow-up between treatment groups.||||||0.06
72626588|NCT01576783|144781974|OTHER|The reported p-value is for the comparison of the scores between groups (DHA+AA vs. Placebo) at post-intervention follow-up (median of 8.3 months (IQR = 4.8) after trial completion and supplementation stopped).||||||0.14||||||Threshold for statistical significance (\<0.05).|Mixed Models Analysis|Linear mixed models compared continuous scores at follow-up between treatment groups.||||||0.14
72626589|NCT01576783|144781974|OTHER|The reported p-value is for the comparison of the scores between groups (DHA+AA vs. Placebo) at post-intervention follow-up (median of 8.3 months (IQR = 4.8) after trial completion and supplementation stopped).||||||0.13||||||Threshold for statistical significance (\<0.05).|Mixed Models Analysis|Linear mixed models compared continuous scores at follow-up between treatment groups.||||||0.13
72535395|NCT02268214|144600036|SUPERIORITY||Median Difference (Final Values)|-0.45|STANDARD_ERROR_OF_MEAN|0.0696|<|0.0001|TWO_SIDED|95.0|-0.58|-0.31|||RMM|Repeated Measures Model||||-0.31|-0.58|<0.0001
72535396|NCT02268214|144600037|SUPERIORITY||Mean Difference (Final Values)|-8.8|STANDARD_ERROR_OF_MEAN|1.9555|<|0.0001|TWO_SIDED|95.0|-12.56|-4.88|||RMM|Repeated Measures Model||||-4.88|-12.56|<0.0001
72535397|NCT02268214|144600037|SUPERIORITY||Mean Difference (Final Values)|-13.17|STANDARD_ERROR_OF_MEAN|1.8643|<|0.0001|TWO_SIDED|95.0|-16.75|-9.43|||RMM|Repeated Measures Model||||-9.43|-16.75|<0.0001
72535398|NCT02268214|144600038|SUPERIORITY||Mean Difference (Final Values)|-3.05|STANDARD_ERROR_OF_MEAN|0.3251|<|0.0001|TWO_SIDED|95.0|-3.68|-2.41|||RMM|Repeated Measures Model||||-2.41|-3.68|<0.0001
72573023|NCT03118570|144673082|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.069||||||Analysis is based on a log transformed ANCOVA model with change from baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 24||||0.069
72626590|NCT01576783|144781974|OTHER|The reported p-value is for the comparison of the scores between groups (DHA+AA vs. Placebo) at post-intervention follow-up (median of 8.3 months (IQR = 4.8) after trial completion and supplementation stopped).||||||0.16||||||Threshold for statistical significance (\<0.05).|Mixed Models Analysis|Linear mixed models compared continuous scores at follow-up between treatment groups.||||||0.16
72626591|NCT01576783|144781975|OTHER|The reported p-value is for the comparison of the scores between groups (DHA+AA vs. Placebo) at post-intervention follow-up (median of 8.3 months (IQR = 4.8) after trial completion and supplementation stopped).||||||0.98|||||||Mixed Models Analysis|Linear mixed models compared continuous scores at follow-up between treatment groups.||||||0.98
72573024|NCT03118570|144673082|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.625||||||Analysis is based on a log transformed ANCOVA model with change from baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 24||||0.625
72369218|NCT00611026|144248556|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.1||0.0043|TWO_SIDED|95.0|-0.6|-0.1|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.|"Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type:~standard error of the mean."|Treatment difference Tolterodine ER vs placebo at Week 4.||-0.1|-0.6|0.0043
72573025|NCT03118570|144673083|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.615||||||Analysis is based on a log transformed ANCOVA model with change from baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 6||||0.615
72573026|NCT03118570|144673083|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.376||||||Analysis is based on a log transformed ANCOVA model with change from baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 12||||0.376
72408364|NCT01192152|144325194|SUPERIORITY_OR_OTHER||Geometric least squares mean (ng*hr/mL)|9246.8||||||95.0||||||||Geometric least squares mean for Treatment A||||
72535399|NCT02268214|144600038|SUPERIORITY||Mean Difference (Final Values)|-3.72|STANDARD_ERROR_OF_MEAN|0.3213|<|0.0001|TWO_SIDED|95.0|-4.34|-3.08|||RMM|Repeated Measures Model||||-3.08|-4.34|<0.0001
72535400|NCT02268214|144600039|SUPERIORITY||Mean Difference (Final Values)|-15.34|STANDARD_ERROR_OF_MEAN|2.4859|<|0.0001|TWO_SIDED|95.0|-20.22|-10.46|||RMM|Repeated Measures Model||||-10.46|-20.22|<0.0001
72535401|NCT02268214|144600039|SUPERIORITY||Mean Difference (Final Values)|-18.03|STANDARD_ERROR_OF_MEAN|2.505|<|0.0001|TWO_SIDED|95.0|-22.95|-13.11|||RMM|Repeated Measures Model||||-13.11|-22.95|<0.0001
72535402|NCT02268214|144600040|SUPERIORITY||Mean Difference (Final Values)|-17.3|STANDARD_ERROR_OF_MEAN|2.6273|<|0.0001|TWO_SIDED|95.0|-22.46|-12.14|||RMM|Repeated Measures Model||||-12.14|-22.46|<0.0001
72535403|NCT02268214|144600040|SUPERIORITY||Mean Difference (Final Values)|-18.93|STANDARD_ERROR_OF_MEAN|2.6482|<|0.0001|TWO_SIDED|95.0|-24.13|-13.73|||RMM|Repeated Measures Model||||-13.73|-24.13|<0.0001
72573027|NCT03118570|144673083|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.259||||||Analysis is based on a log transformed ANCOVA model with change from baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 6||||0.259
72535404|NCT02268214|144600041|SUPERIORITY||Mean Difference (Final Values)|9.11|STANDARD_ERROR_OF_MEAN|1.1611|<|0.0001|TWO_SIDED|95.0|6.83|11.39|||RMM|Repeated Measures Model||||11.39|6.83|<0.0001
72573028|NCT03118570|144673083|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.253||||||Analysis is based on a log transformed ANCOVA model with change from baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 12||||0.253
72573029|NCT03118570|144673084|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.064||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 6||||0.064
72573030|NCT03118570|144673084|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.019||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 6||||0.019
72573031|NCT03118570|144673084|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.845||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 6||||0.845
72573032|NCT03118570|144673084|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.006||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 12||||0.006
72573033|NCT03118570|144673084|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.19||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 12||||0.190
72573034|NCT03118570|144673084|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.704||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 12||||0.704
72626592|NCT01576783|144781975|OTHER|The reported p-value is for the comparison of the scores between groups (DHA+AA vs. Placebo) at post-intervention follow-up (median of 8.3 months (IQR = 4.8) after trial completion and supplementation stopped).||||||0.67||||||Threshold for statistical significance (\<0.05).|Mixed Models Analysis|Linear mixed models compared continuous scores at follow-up between treatment groups.||||||0.67
72535405|NCT02268214|144600041|SUPERIORITY||Mean Difference (Final Values)|10.65|STANDARD_ERROR_OF_MEAN|1.1689|<|0.0001|TWO_SIDED|95.0|8.35|12.94|||RMM|Repeated Measures Model||||12.94|8.35|<0.0001
72535406|NCT02268214|144600042|SUPERIORITY||Odds Ratio (OR)|3.09|STANDARD_ERROR_OF_MEAN|0.198|<|0.0001|TWO_SIDED|95.0|2.1|4.56|||Regression, Logistic|||||4.56|2.10|<0.0001
72535407|NCT02268214|144600042|SUPERIORITY||Odds Ratio (OR)|3.29|STANDARD_ERROR_OF_MEAN|0.1979|<|0.0001|TWO_SIDED|95.0|2.23|4.85|||Regression, Logistic|||||4.85|2.23|<0.0001
72535408|NCT04342390|144600043|SUPERIORITY|||||||0.363|||||||ANCOVA|||||||0.363
72573035|NCT03118570|144673084|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.002||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 18||||0.002
72573036|NCT03118570|144673084|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.021||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 18||||0.021
72573037|NCT03118570|144673084|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.504||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 18||||0.504
72535409|NCT04342390|144600044|SUPERIORITY|||||||0.633|||||||ANCOVA|||||||0.633
72573038|NCT03118570|144673084|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.462||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 24||||0.462
72573039|NCT03118570|144673084|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.134||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 24||||0.134
72535410|NCT04342390|144600045|SUPERIORITY|||||||0.433|||||||ANCOVA|||||||0.433
72535411|NCT04342390|144600046|SUPERIORITY|||||||0.822|||||||ANCOVA|||||||0.822
72535412|NCT04342390|144600047|SUPERIORITY|||||||0.554|||||||ANCOVA|||||||0.554
72535413|NCT04342390|144600048|SUPERIORITY|||||||0.186|||||||ANCOVA|||||||0.186
72535414|NCT04342390|144600049|SUPERIORITY|||||||0.921|||||||ANCOVA|||||||0.921
72535415|NCT00318357|144600070|SUPERIORITY|||||||0.007|||||||Regression, Cox|||Mortality is compared between the arms of the CARE-HF study, using Cox proportional hazards regression. Data from the original CARE-HF trial and the CARE-HF Long Term Follow-up trial were combined for the analysis.||||0.007
72535416|NCT03378921|144600073|SUPERIORITY|||||||0.183||||||The threshold for statistical significance was P = 0.05|Log Rank|||The sample size (n = 26) was calculated according to the estimation that the remission rate in the FMT group would be 80% and 25% in the placebo group during the follow-up of 1 year. This difference of 55% was considered to be clinically meaningful. The significance level was selected to be 1%, and the power was set to 90%.||||0.183
72535417|NCT01054443|144600126|OTHER||Cochran-Armitage Trend Test Statistic|0.173||||0.431|||||||Cochran-Armitage Trend Test|||The primary efficacy evaluation was to test if there was a linear relationship existing such that the higher the dose level, the larger the percentage of responders. The Cochran-Armitage trend test was employed by assigning the score 0, 0.5, 0.75, and 1 to placebo, lusutrombopag 0.5, 0.75, and 1.0 mg group, respectively, at the 0.025 level of significance (1-sided) to determine the test statistic for detecting a dose-response in the percentage of responders.||||0.431
72408365|NCT01192152|144325196|NON_INFERIORITY_OR_EQUIVALENCE|BE was concluded if the 90% CIs for the test-to-reference ratios of geometric means were entirely contained within 0.800 to 1.250 for both Cmax and AUC0-inf of metformin.|ratio of geometric least squares means|0.917|||||TWO_SIDED|90.0|0.859|0.98|||||Ratio = Treatment B/Treatment A. Geometric least squares means values are presented in other statistical analysis entries.|If there was no difference between the bioavailabilities of metformin from the FDC tablet versus metformin from coadministration of a 5-mg saxagliptin tablet plus two 500-mg metformin XR tablets under fed conditions, then 24 subjects would have provided 99% power to conclude BE with respect to Cmax and AUC0-inf. If there was a 5% difference, then 24 subjects would have provided at least 99% power to conclude BE with respect to Cmax and AUC0-inf.||0.980|0.859|
72408366|NCT01192152|144325196|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean (ng*hr/mL)|1055.9||||||95.0||||||||Geometric least squares means for Treatment B||||
72408367|NCT01192152|144325196|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean (ng*hr/mL)|1151.2||||||95.0||||||||Geometric least squares means for Treatment A||||
72408368|NCT02203591|144325209|SUPERIORITY||||||<|0.0001|||||||Chi-squared|||||||<0.0001
72535418|NCT01054443|144600127|OTHER||LS Mean Difference|25544.0|||||TWO_SIDED|95.0|6202.8|44885.3|||||The difference of least squares means (LSMeans) between each of the lusutrombopag treatment groups and placebo was estimated after adjusting for the Baseline platelet count using analysis of covariance (ANCOVA).|||44885.3|6202.8|
72535419|NCT01054443|144600127|OTHER||LS Mean Difference|11801.3|||||TWO_SIDED|95.0|-8809.3|32411.9|||||The difference of least squares means (LSMeans) between each of the lusutrombopag treatment groups and placebo was estimated after adjusting for the Baseline platelet count using analysis of covariance (ANCOVA).|||32411.9|-8809.3|
72535420|NCT01054443|144600127|OTHER||LS Mean Difference|756.6|||||TWO_SIDED|95.0|-18794.3|20307.5|||||The difference of least squares means (LSMeans) between each of the lusutrombopag treatment groups and placebo was estimated after adjusting for the Baseline platelet count using analysis of covariance (ANCOVA).|||20307.5|-18794.3|
72535421|NCT05405218|144600203|SUPERIORITY||Mean Difference (Net)|0.08||||0.46|TWO_SIDED|95.0|-0.13|0.29|||Mixed Models Analysis|||||0.29|-0.13|0.46
72535422|NCT05405218|144600204|SUPERIORITY||Mean Difference (Net)|0.01||||0.92|TWO_SIDED|95.0|-0.2|0.23|||Mixed Models Analysis|||||0.23|-0.2|0.92
72573040|NCT03118570|144673084|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.086||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 24||||0.086
72573041|NCT03118570|144673084|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.199||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 6||||0.199
72408369|NCT02203591|144325209|SUPERIORITY||||||<|0.0001|||||||Chi-squared|||||||<0.0001
72408370|NCT02203591|144325209|SUPERIORITY||||||<|0.0001|||||||Chi-squared|||||||<0.0001
72408371|NCT02203591|144325209|SUPERIORITY||||||<|0.0001|||||||Chi-squared|||||||<0.0001
72408372|NCT02203591|144325209|SUPERIORITY||||||<|0.0001|||||||Chi-squared|||||||<0.0001
72535423|NCT05405218|144600206|SUPERIORITY||Mean Difference (Net)|0.61||||0.09|TWO_SIDED|95.0|-0.08|1.3|||Mixed Models Analysis|||||1.3|-0.08|0.09
72535424|NCT05405218|144600207|SUPERIORITY||Mean Difference (Net)|0.0||||0.9|TWO_SIDED|95.0|-0.06|0.05|||Mixed Models Analysis|||||0.05|-0.06|0.9
72535425|NCT00157820|144600216|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.31||||0.0028|TWO_SIDED|95.0|0.14|0.67|||Wilcoxon (Mann-Whitney)||An additional primary analysis was pre-planned: the odds ratio of CSAE-score between DC and SC obtained from SAS GENMOD procedure with the length of follow-up as an 'offset'.|"The assumed effect of the DC treatment was a reduction from 30 to 15% in the proportion of patients who develop a CSAE, as well as a 15% reduction in the mean of CSAE (from 6 to 5.1). The estimated sample size was 200 (DC true) vs. 100 (SC true) patients followed for 8 months, with a two-sided alfa \< 0.05 and a power of 88.8%.~The sample size was set up to 360 patients (120 patients per arm), considering losses in follow-up."||0.67|0.14|0.0028
72573042|NCT03118570|144673084|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.219||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 8||||0.219
72408373|NCT02203591|144325209|SUPERIORITY||||||<|0.0001|||||||Chi-squared|||||||<0.0001
72408374|NCT02203591|144325209|OTHER|95% confidence interval generation|Mean value|81.1|||||TWO_SIDED|95.0|75.6|86.6||||||||86.6|75.6|
72408375|NCT02203591|144325209|OTHER|95% confidence interval generation|Mean value|81.7|||||TWO_SIDED|95.0|76.3|87.1||||||||87.1|76.3|
72408376|NCT02203591|144325209|OTHER|95% confidence interval generation|Mean value|83.2|||||TWO_SIDED|95.0|77.9|88.4||||||||88.4|77.9|
72408377|NCT02203591|144325209|OTHER|95% confidence interval generation|Mean value|38.9|||||TWO_SIDED|95.0|32.3|45.6||||||||45.6|32.3|
72408378|NCT02203591|144325209|OTHER|95% confidence interval generation|Mean value|46.9|||||TWO_SIDED|95.0|40.1|53.7||||||||53.7|40.1|
72408379|NCT02203591|144325209|OTHER|95% confidence interval generation|Mean value|53.0|||||TWO_SIDED|95.0|46.3|59.6||||||||59.6|46.3|
72408380|NCT02203591|144325210|NON_INFERIORITY|A non-inferior margin of 0.5 log10/cm\^2|Mean Difference (Final Values)|-0.34|STANDARD_ERROR_OF_MEAN|0.12|||TWO_SIDED|95.0|-0.57|-0.1|||||3M CHG/IPA C - Inguinal minus ChloraPrep - Inguinal|||-0.10|-0.57|
72535426|NCT00437294|144600245|SUPERIORITY_OR_OTHER_LEGACY|||||||0.237||||||The 1-sided significance level was 0.20.|Log Rank|||||||0.237
72535427|NCT00437294|144600250|SUPERIORITY_OR_OTHER_LEGACY|||||||1||||||1-sided significance level was 0.20.|Fisher Exact|||||||1.00
72535428|NCT00437294|144600251|SUPERIORITY_OR_OTHER_LEGACY|||||||0.812|||||||Log Rank|||||||0.812
72535429|NCT00437294|144600252|SUPERIORITY_OR_OTHER_LEGACY|||||||0.181|||||||Log Rank|||||||0.181
72535430|NCT02277665|144600254|SUPERIORITY|Chi-square|Odds Ratio (OR)|0.56|||=|0.33|TWO_SIDED|95.0|0.17|1.82|||Chi-squared|||||1.82|.17|= 0.33
72535431|NCT02277665|144600255|OTHER||Odds Ratio (OR)|0.32||||0.57|TWO_SIDED||||||Chi-squared|||||||0.57
72535432|NCT02277665|144600256|OTHER||Odds Ratio (OR)|0.45|||=|0.16|TWO_SIDED|95.0|0.15|1.35|||Chi-squared|||||1.35|0.15|= 0.16
72535433|NCT02277665|144600257|SUPERIORITY||Means Ratio|0.97||||0.87|TWO_SIDED|95.0|0.66|1.42|||Chi-squared|||||1.42|0.66|0.87
72535434|NCT02277665|144600258|SUPERIORITY|||||||0.46|||||||t-test, 2 sided|||||||0.46
72408381|NCT02203591|144325210|NON_INFERIORITY|A non-inferior margin of 0.5 log10/cm\^2|Mean Difference (Final Values)|-0.18|STANDARD_ERROR_OF_MEAN|0.11|||TWO_SIDED|97.5|-0.44|0.74|||||3M CHG/IPA CH - Inguinal minus ChloraPrep - Inguinal|Since there are two investigational products a Hochberg step-up procedure was used to adjust for multiplicity.||0.74|-0.44|
72408382|NCT02203591|144325211|OTHER|Calculate mean value|Mean value|2.83|STANDARD_DEVIATION|0.85|||TWO_SIDED|||||||||||||
72408383|NCT02203591|144325211|OTHER|Calculate mean value|Mean value|2.86|STANDARD_DEVIATION|0.9|||TWO_SIDED|||||||||||||
72408384|NCT02203591|144325211|OTHER|Calculate mean value|Mean value|2.83|STANDARD_DEVIATION|0.97|||TWO_SIDED|||||||||||||
72408385|NCT02203591|144325211|OTHER|Calculate mean value|Mean value|1.0|STANDARD_DEVIATION|0.97|||TWO_SIDED|||||||||||||
72535435|NCT02277665|144600259|SUPERIORITY|||||||0.04|||||||Chi-squared|||||||0.04
72535436|NCT03309072|144600260|OTHER|To compare the old and new faces' hit rate, we calculated the true positive rate (TPR: the proportion of positives that are correctly identified as such). A repeated measures ANOVA was conducted with the TPR for both old and new faces as within-subjects variable and group (active vs sham) as between-subjects variable.|Mean Difference (Net)|10.66|||<|0.049|TWO_SIDED||||||ANOVA||Difference between active tDCS and sham tDCS|||||<.049
72535437|NCT00124709|144600374|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0046||||0.7901|TWO_SIDED|95.0|-0.029|0.0381|||ANCOVA|Treatment, Center, gender, baseline age (months), baseline EASI score, and baseline TBSA as explanatory variables||"A disease-free day in Step 2 or less was defined as a diary day with variable No or almost no eczema?=yes and medication used variable=no except emollients, yellow label medication 2X day, or medication deviation of yellow label medication 1x day."||0.0381|-0.0290|0.7901
72535438|NCT01728376|144600388|SUPERIORITY_OR_OTHER||Difference (%)|-2.5|||||TWO_SIDED|95.0|-30.3|25.3|||||Daptomycin minus Comparator 95% Confidence Interval (CI) by Wilson score method|Difference in satisfactory response between treatment groups. Satisfactory response = cured + improved||25.3|-30.3|
72535439|NCT01728376|144600388|SUPERIORITY_OR_OTHER||Difference (%)|16.3|||||TWO_SIDED|95.0|-13.0|45.7|||||Daptomycin minus Comparator 95% CI by Wilson score method|Difference in satisfactory response between treatment groups. Satisfactory response = cured + improved||45.7|-13.0|
72535440|NCT01728376|144600388|SUPERIORITY_OR_OTHER||Difference (%)|25.7|||||TWO_SIDED|95.0|-21.0|72.4|||||Daptomycin minus Comparator 95% CI by Wilson score method|Difference in satisfactory response between treatment groups. Satisfactory response = cured + improved||72.4|-21.0|
72573043|NCT03118570|144673084|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.112||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 6||||0.112
72408386|NCT02203591|144325211|OTHER|Calculate mean value|Mean value|3.46|STANDARD_DEVIATION|1.31|||TWO_SIDED|||||||||||||
72408387|NCT02203591|144325211|OTHER|Calculate mean value|Mean value|3.49|STANDARD_DEVIATION|1.33|||TWO_SIDED|||||||||||||
72408388|NCT02203591|144325211|OTHER|Calculate mean value|Mean value|3.69|STANDARD_DEVIATION|1.29|||TWO_SIDED|||||||||||||
72408389|NCT02203591|144325211|OTHER|Calculate mean value|Mean value|1.23|STANDARD_DEVIATION|0.73|||TWO_SIDED|||||||||||||
72408390|NCT02203591|144325212|OTHER|Calculate mean value|Mean value|2.78|STANDARD_DEVIATION|0.94|||TWO_SIDED|||||||||||||
72535441|NCT01728376|144600389|SUPERIORITY_OR_OTHER||Difference (%)|5.0|||||TWO_SIDED|95.0|-29.8|39.8|||||Daptomycin minus Comparator 95% CI by Wilson score method|Difference in success response between treatment arms||39.8|-29.8|
72408391|NCT02203591|144325212|OTHER|Calculate mean value|Mean value|2.73|STANDARD_DEVIATION|1.0|||TWO_SIDED|||||||||||||
72408392|NCT02203591|144325212|OTHER|Calculate mean value|Mean value|2.75|STANDARD_DEVIATION|0.97|||TWO_SIDED|||||||||||||
72408393|NCT02203591|144325212|OTHER|Calculate mean value|Mean value|0.76|STANDARD_DEVIATION|0.81|||TWO_SIDED|||||||||||||
72408394|NCT02203591|144325212|OTHER|Calculate mean value|Mean value|2.84|STANDARD_DEVIATION|1.19|||TWO_SIDED|||||||||||||
72408395|NCT02203591|144325212|OTHER|Calculate mean value|Mean value|2.99|STANDARD_DEVIATION|1.12|||TWO_SIDED|||||||||||||
72408396|NCT02203591|144325212|OTHER|Calculate mean value|Mean value|3.17|STANDARD_DEVIATION|1.24|||TWO_SIDED|||||||||||||
72408397|NCT02203591|144325212|OTHER|Calculate mean value|Mean value|1.01|STANDARD_DEVIATION|0.67|||TWO_SIDED|||||||||||||
72408398|NCT02203591|144325213|OTHER|Calculate mean value|Mean value|0.8|STANDARD_DEVIATION|0.84|||TWO_SIDED|||||||||||||
72408399|NCT02203591|144325213|OTHER|Calculate mean value|Mean value|0.74|STANDARD_DEVIATION|0.79|||TWO_SIDED|||||||||||||
72408400|NCT02203591|144325213|OTHER|Calculate mean value|Mean value|0.81|STANDARD_DEVIATION|0.94|||TWO_SIDED|||||||||||||
72408401|NCT02203591|144325213|OTHER|Calculate mean value|Mean value|2.65|STANDARD_DEVIATION|0.89|||TWO_SIDED|||||||||||||
72408402|NCT02203591|144325213|OTHER|Calculate mean value|Mean value|2.76|STANDARD_DEVIATION|1.2|||TWO_SIDED|||||||||||||
72408403|NCT02203591|144325213|OTHER|Calculate mean value|Mean value|2.73|STANDARD_DEVIATION|1.22|||TWO_SIDED|||||||||||||
72408404|NCT02203591|144325213|OTHER|Calculate mean value|Mean value|2.58|STANDARD_DEVIATION|1.18|||TWO_SIDED|||||||||||||
72408405|NCT02203591|144325213|OTHER|Calculate mean value|Mean value|4.85|STANDARD_DEVIATION|0.75|||TWO_SIDED|||||||||||||
72408406|NCT02203591|144325214|OTHER|Calculate mean value|Mean value|0.85|STANDARD_DEVIATION|0.95|||TWO_SIDED|||||||||||||
72408407|NCT02203591|144325214|OTHER|Calculate mean value|Mean value|0.87|STANDARD_DEVIATION|0.98|||TWO_SIDED|||||||||||||
72408408|NCT02203591|144325214|OTHER|Calculate mean value|Mean value|0.89|STANDARD_DEVIATION|0.94|||TWO_SIDED|||||||||||||
72408409|NCT02203591|144325214|OTHER|Calculate mean value|Mean value|2.88|STANDARD_DEVIATION|0.7|||TWO_SIDED|||||||||||||
72535442|NCT01728376|144600389|SUPERIORITY_OR_OTHER||Difference (%)|37.9|||||TWO_SIDED|95.0|0.7|75.1|||||Daptomycin minus Comparator 95% CI by Wilson score method|Difference in success response between treatment arms||75.1|0.7|
72535443|NCT01728376|144600389|SUPERIORITY_OR_OTHER||Difference (%)|-10.0||||||95.0|-60.3|40.3|||||Daptomycin minus Comparator 95% CI by Wilson score method|Difference in success response between treatment arms||40.3|-60.3|
72535444|NCT01683331|144600396|SUPERIORITY||Odds Ratio (OR)|1.03||||0.87|TWO_SIDED|95.0|1.01|1.06|||Chi-squared|||||1.06|1.01|0.87
72535445|NCT01683331|144600397|SUPERIORITY||Odds Ratio (OR)|1.3||||0.92|TWO_SIDED|95.0|1.2|2.8|||Chi-squared|||||2.8|1.2|0.92
72535446|NCT03491800|144600402|SUPERIORITY||Mean Difference (Net)|7.5|STANDARD_ERROR_OF_MEAN|0.15||0.3|TWO_SIDED||||||t-test, 2 sided|||||||0.30
72408410|NCT02203591|144325214|OTHER|Calculate mean value|Mean value|3.39|STANDARD_DEVIATION|1.1|||TWO_SIDED|||||||||||||
72535447|NCT03491800|144600403|SUPERIORITY||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.43||0.9|TWO_SIDED||||||t-test, 2 sided|||||||0.90
72535448|NCT03491800|144600403|SUPERIORITY||Mean Difference (Final Values)|4.44|STANDARD_ERROR_OF_MEAN|0.26||0.3|TWO_SIDED||||||t-test, 2 sided|||||||0.30
72535449|NCT03491800|144600404|SUPERIORITY||Mean Difference (Final Values)|-3.03|STANDARD_ERROR_OF_MEAN|-0.28||0.4|TWO_SIDED||||||t-test, 2 sided|||||||0.40
72535450|NCT03491800|144600404|SUPERIORITY||Mean Difference (Final Values)|0.93|STANDARD_ERROR_OF_MEAN|0.22||0.85|TWO_SIDED||||||t-test, 2 sided|||||||0.85
72535451|NCT03491800|144600405|SUPERIORITY||Mean Difference (Final Values)|-5.05|STANDARD_ERROR_OF_MEAN|-0.25||0.21|TWO_SIDED||||||t-test, 2 sided|||||||0.21
72535452|NCT03491800|144600406|SUPERIORITY||Mean Difference (Final Values)|0.3|STANDARD_ERROR_OF_MEAN|0.23||0.95|TWO_SIDED||||||t-test, 2 sided|||||||0.95
72535453|NCT03491800|144600407|SUPERIORITY||Mean Difference (Final Values)|3.34|STANDARD_ERROR_OF_MEAN|-0.2||0.52|TWO_SIDED||||||t-test, 2 sided|||||||0.52
72535454|NCT03491800|144600408|SUPERIORITY||Mean Difference (Final Values)|-38.25|STANDARD_ERROR_OF_MEAN|-38.25||0.23|TWO_SIDED||||||t-test, 2 sided|||||||0.23
72535455|NCT03491800|144600408|SUPERIORITY||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|22.0||0.67|TWO_SIDED||||||t-test, 2 sided|||||||0.67
72408411|NCT02203591|144325214|OTHER|Calculate mean value|Mean value|3.21|STANDARD_DEVIATION|1.04|||TWO_SIDED|||||||||||||
72408412|NCT02203591|144325214|OTHER|Calculate mean value|Mean value|3.08|STANDARD_DEVIATION|1.14|||TWO_SIDED|||||||||||||
72535456|NCT03491800|144600408|SUPERIORITY||Mean Difference (Final Values)|-0.26|STANDARD_ERROR_OF_MEAN|9.62||0.054|TWO_SIDED||||||t-test, 2 sided|||||||0.054
72535457|NCT03491800|144600409|SUPERIORITY||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|5.4||0.6|TWO_SIDED||||||t-test, 2 sided|||||||0.60
72535458|NCT03491800|144600409|SUPERIORITY||Mean Difference (Final Values)|0.28|STANDARD_ERROR_OF_MEAN|3.29||0.4|TWO_SIDED||||||t-test, 2 sided|||||||0.40
72535459|NCT01256086|144600414|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Relative potency of Novolizer compared to Aerolizer. Equivalence was to be concluded if the CI for the relative potency was completely covered by the interval (0.67, 1.50) according to OIP Guideline.|Relative potency|1.13|||||TWO_SIDED|90.0|0.94|1.38|||||Fieller confidence interval for logarithm of relative potency|||1.38|0.94|
72408413|NCT02203591|144325214|OTHER|Calculate mean value|Mean value|5.08|STANDARD_DEVIATION|0.68|||TWO_SIDED|||||||||||||
72408414|NCT02203591|144325215|OTHER|Calculate mean value|Mean value|3.63|STANDARD_DEVIATION|0.46|||TWO_SIDED|||||||||||||
72408415|NCT02203591|144325215|OTHER|Calculate mean value|Mean value|3.61|STANDARD_DEVIATION|0.48|||TWO_SIDED|||||||||||||
72535460|NCT05604521|144600417|SUPERIORITY|||||||0.3944|||||||Fisher Exact|||Null hypothesis: There is no statistically significant difference between the vaccine and control groups in the proportion of participants experiencing any local solicited AEs after any vaccination.||||0.3944
72535461|NCT05604521|144600417|SUPERIORITY|||||||0.3717|||||||Fisher Exact|||Null hypothesis: There is no statistically significant difference between the vaccine and control groups in the proportion of participants experiencing any systemic solicited AEs after any vaccination.||||0.3717
72535462|NCT05604521|144600417|SUPERIORITY|||||||1|||||||Fisher Exact|||Null hypothesis: There is no statistically significant difference between the vaccine and control groups in the proportion of participants experiencing any related unsolicited AEs after any vaccination.||||1.0
72535463|NCT01491737|144600435|SUPERIORITY||Hazard Ratio (HR)|0.65||||0.007|TWO_SIDED|95.0|0.48|0.89||Test was performed at 2-sided alpha of 5%.|Log Rank|Stratified log-rank test based upon Kaplan-Meier including induction chemotherapy and prior adjuvant hormone therapy stratification factors.|Hazard ratio comparing Arm A vs. B from stratified Cox proportional hazards model including stratification factors.|Primary Analysis. Log Rank tested the following: Null Hypothesis (H0): the distribution of the PFS time was the same in Arms A \& B; The Alternative Hypothesis (H1): the distribution of the PFS time was different in Arms A \& B. A Cox proportional hazards model tested the HR. If the HR of investigational arm (Arm A) compared with control arm (Arm B) with respect to PFS was assumed to be constant over time (λ) then the null (H0) and alternative hypotheses (H1) were: H0: λ =1; H1: λ ≠1.||0.89|0.48|0.0070
72535464|NCT01491737|144600435|OTHER|Exploratory|Hazard Ratio (HR)|0.67||||0.0059|TWO_SIDED|95.0|0.5|0.89|||Log Rank|Stratified log-rank test based upon Kaplan-Meier including induction chemotherapy and prior adjuvant hormone therapy stratification factors.|Hazard ratio comparing Arm A vs. B from stratified Cox proportional hazards model including stratification factors.|Final Analysis||0.89|0.50|0.0059
72535465|NCT01491737|144600436|OTHER|Exploratory|Hazard Ratio (HR)|1.15||||0.585|TWO_SIDED|95.0|0.69|1.91|||Log Rank|Stratified log-rank test based upon Kaplan-Meier including induction chemotherapy and prior adjuvant hormone therapy stratification factors.|Hazard ratio comparing Arm A vs. B from stratified Cox proportional hazards model including stratification factors.|Primary Analysis. This study was not powered for overall survival (OS), so adequately powered statistical testing for this outcome measure was not possible.||1.91|0.69|0.5850
72535466|NCT01491737|144600436|OTHER|Exploratory|Hazard Ratio (HR)|1.05||||0.7833|TWO_SIDED|95.0|0.73|1.52|||Log Rank|Stratified log-rank test based upon Kaplan-Meier including induction chemotherapy and prior adjuvant hormone therapy stratification factors.|Hazard ratio comparing Arm A vs. B from stratified Cox proportional hazards model including stratification factors.|Final Analysis. This study was not powered for overall survival (OS), so adequately powered statistical testing for this outcome measure was not possible.||1.52|0.73|0.7833
72626593|NCT01576783|144781976|OTHER|The reported p-value is for the comparison of the scores between groups (DHA+AA vs. Placebo) at post-intervention follow-up (median of 8.3 months (IQR = 4.8) after trial completion and supplementation stopped).||||||0.047||||||Threshold for statistical significance (\<0.05).|Mixed Models Analysis|Linear mixed models compared continuous scores at follow-up between treatment groups.||||||0.047
72408416|NCT02203591|144325215|OTHER|Calculate mean value|Mean value|3.64|STANDARD_DEVIATION|0.49|||TWO_SIDED|||||||||||||
72408417|NCT02203591|144325215|OTHER|Calculate mean value|Mean value|3.64|STANDARD_DEVIATION|0.53|||TWO_SIDED|||||||||||||
72408418|NCT02203591|144325215|OTHER|Calculate mean value|Mean value|6.23|STANDARD_DEVIATION|0.6|||TWO_SIDED|||||||||||||
72535467|NCT01491737|144600437|SUPERIORITY||Difference in ORR|7.6||||0.2537|TWO_SIDED|95.0|-6.0|21.3||Test was performed at 2-sided alpha of 5%. There was no multiplicity adjustment.|Chi-squared|||ORR for Arm A vs Arm B||21.3|-6.0|0.2537
72535468|NCT01491737|144600438|SUPERIORITY||Difference in CBR|1.8||||0.7743|TWO_SIDED|95.0|-11.2|14.8||Test was performed at 2-sided alpha of 5%. There was no multiplicity adjustment.|Chi-squared|||CBR for Arm A vs. Arm B||14.8|-11.2|0.7743
72535469|NCT01491737|144600439|SUPERIORITY||Hazard Ratio (HR)|0.57||||0.0181|TWO_SIDED|95.0|0.36|0.91||Test was performed at 2-sided alpha of 5%.|Log Rank|Log-rank test from unstratified analysis based upon Kaplan-Meier approach. There was no multiplicity adjustment.|Hazard ratio from stratified Cox proportional hazards model including stratification factors of induction chemotherapy and prior adjuvant hormone therapy.|Primary Analysis. Log Rank tested the following: Null Hypothesis (H0): the distribution of the DOR time was the same in Arms A \& B; The Alternative Hypothesis (H1): the distribution of the DOR time was different in Arms A \& B. A Cox proportional hazards model tested the HR. If the HR of investigational arm (Arm A) compared with control arm (Arm B) with respect to DOR was assumed to be constant over time (λ) then the null (H0) and alternative hypotheses (H1) were: H0: λ =1; H1: λ ≠1.||0.91|0.36|0.0181
72535470|NCT01491737|144600439|OTHER|Exploratory|Hazard Ratio (HR)|0.62||||0.0205|TWO_SIDED|95.0|0.41|0.93|||Log Rank|Log-rank test from unstratified analysis based upon Kaplan-Meier approach. There was no multiplicity adjustment.|Hazard ratio from stratified Cox proportional hazards model including stratification factors of induction chemotherapy and prior adjuvant hormone therapy.|Final Analysis.||0.93|0.41|0.0205
72535471|NCT01491737|144600440|SUPERIORITY||Hazard Ratio (HR)|1.11||||0.5597|TWO_SIDED|95.0|0.78|1.57||Test was performed at 2-sided alpha of 5%.|Log Rank|The log-rank test from unstratified analysis was based upon Kaplan-Meier approach. There was no multiplicity adjustment.|Hazard ratio from stratified Cox proportional hazards model including the induction chemotherapy and prior adjuvant hormone therapy stratification factors.|Log Rank tested the following: Null Hypothesis (H0): the distribution of the TTR time was the same in Arms A \& B; The Alternative Hypothesis (H1): the distribution of the TTR time was different in Arms A \& B. A Cox proportional hazards model tested the HR. If the HR of investigational arm (Arm A) compared with control arm (Arm B) with respect to TTR was assumed to be constant over time (λ) then the null (H0) and alternative hypotheses (H1) were: H0: λ =1; H1: λ ≠1.||1.57|0.78|0.5597
72535472|NCT05279807|144600449|SUPERIORITY||Mean difference pre vs post treatment|-13.5|||<|0.001|TWO_SIDED|95.0|-14.5|-12.5|||Paired Samples T-Test|||Primary endpoint, verified on the single cohort of patients who completed the monotherapy run-in period, is calculated as the mean difference in sitting diastolic blood pressure between Visit 2 (Week 0, Baseline Visit of the combination therapy) and Visit 4 (Week 8, End of Study Visit). This is not a comparison of two different arms, but a comparison of two measurements taken from the same patient treated with combination therapy (single arm paired pre- vs. post-combination therapy comparison)||-12.5|-14.5|< 0.001
72535473|NCT00617175|144600485|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||Negative binomial regression|||||||<0.001
72408419|NCT02203591|144325215|OTHER|Calculate mean value|Mean value|6.22|STANDARD_DEVIATION|0.56|||TWO_SIDED|||||||||||||
72408420|NCT02203591|144325215|OTHER|Calculate mean value|Mean value|6.27|STANDARD_DEVIATION|0.62|||TWO_SIDED|||||||||||||
72535474|NCT02203305|144600487|SUPERIORITY||||||<|0.001||||||Percent correct converted to rationalized arcsine units (RAU) prior to analysis.|Mixed Models Analysis|Main effects: interval (p\<0.001) and condition (p\<0.001). Interaction: Interval and condition (p\<0.001).||Recorded 50-word consonant-nucleus-consonant (CNC) words were evaluated for the poorer hearing ear 1) unaided and 2) with the cochlear implant (CI) over the post-activation study period. A repeated-measures ANOVA evaluated the main effects of interval (1, 3, 6, 9, and 12 months post-activation), condition (unaided or with the CI), and their interaction. Percent correct converted to RAU.||||<0.001
72408421|NCT02203591|144325215|OTHER|Calculate mean value|Mean value|6.09|STANDARD_DEVIATION|0.63|||TWO_SIDED|||||||||||||
72408422|NCT01009099|144325273|SUPERIORITY_OR_OTHER|||||||0.63|TWO_SIDED||||||ANCOVA|Co-variates included in the analysis were time walked on the constant workrate test at baseline and adherence (sessions completed/expected).||The outcomes compared were time walked on the constant workrate treadmill test measured in minutes.||||0.63
72535475|NCT02203305|144600487|SUPERIORITY||||||<|0.001||||||Percent correct converted to rationalized arcsine units (RAU) prior to analysis.|Mixed Models Analysis|Main effects: interval (p\<0.001) and condition (p\<0.001). Interaction: interval and condition (p\<0.001).||Recorded 50-word CNC words were evaluated for the poorer hearing ear 1) unaided and 2) with the cochlear implant (CI) over the post-activation study period. A repeated-measures ANOVA evaluated the main effects of interval (1, 3, 6, 9, and 12 months post-activation), condition (unaided or with the CI), and their interaction. Percent correct converted to RAU.||||<0.001
72535476|NCT02203305|144600487|SUPERIORITY||||||<|0.001||||||Percent correct data were converted to rationalized arcsine units (RAU) prior to data analysis.|ANOVA|A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity.||Recorded 50-word CNC words were evaluated in an unaided condition for the poorer hearing ear pre-operatively and with the cochlear implant (CI) over the study period. A repeated-measures ANOVA evaluated the main effect of interval (before surgery, and 1, 3, 6, 9, and 12 months post-activation). Percent correct converted to RAU.||||<0.001
72626594|NCT01576783|144781977|OTHER|The reported p-value is for the comparison of the scores between groups (DHA+AA vs. Placebo) at post-intervention follow-up (median of 8.3 months (IQR = 4.8) after trial completion and supplementation stopped).||||||0.2||||||Threshold for statistical significance (\<0.05).|Mixed Models Analysis|Linear mixed models compared continuous scores at follow-up between treatment groups. Model controlled for baseline scores.||||||0.20
72408423|NCT02188485|144325274|SUPERIORITY||Mean Difference (Final Values)|-0.79|STANDARD_ERROR_OF_MEAN|0.72||0.278|TWO_SIDED||||||Mixed Models Analysis||This mean difference is not identical to the mean difference presented in the summary table because this mean difference was adjusted for random effects in the model.|Thwarted belonging (INQ-TB) at 10 week follow-up||||.278
72408424|NCT02188485|144325274|SUPERIORITY||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.38||0.591|TWO_SIDED||||||Mixed Models Analysis||This mean difference is not identical to the mean difference presented in the summary table because this mean difference was adjusted for random effects in the model.|Perceived burden (INQ-PB) at 10-week follow-up||||.591
72535477|NCT02203305|144600487|SUPERIORITY||||||<|0.001||||||Percent correct data were converted to rationalized arcsine units (RAU) prior to data analysis.|ANOVA|||Recorded 50-word CNC words were evaluated in an unaided condition for the poorer hearing ear pre-operatively and with the cochlear implant (CI) over the study period. A repeated-measures ANOVA evaluated the main effect of interval (before surgery, and 1, 3, 6, 9, and 12 months post-activation). Percent correct converted to RAU.||||<0.001
72535478|NCT02203305|144600487|SUPERIORITY||||||<|0.429||||||A logit transformation was applied to proportion correct data prior to analysis.|Mixed Models Analysis|Main effects: interval (p\<0.001) and group (p=0.429). Interaction: group and interval (p=0.387).||Comparison of word recognition between groups (UHL/SSD and AHL) over the post-activation intervals (1, 3, 6, 9, and 12 months).||||<0.429
72535479|NCT02203305|144600488|SUPERIORITY||||||<|0.019||||||The Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity.|Mixed Models Analysis|Main effects: interval (p=0.19) and condition (p\<0.001). Interaction: interval and condition (p\<0.019).||Soundfield localization of 200-ms speech-shaped noise, presented from 11 speakers at 60, 70, or 80 decibel (dB) sound pressure level (SPL) in a sound treated room. Overall root-mean-square (RMS) error is the difference between the sound source azimuth and the response azimuth and a lower score indicates more accurate localization of the sound source. A repeated-measures ANOVA evaluated the effects of interval, condition (unaided or with the cochlear implant), and their interaction.||||<0.019
72535480|NCT02203305|144600488|SUPERIORITY||||||<|0.012||||||A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity.|Mixed Models Analysis|Main effects: interval (p=0.012) and condition (p\<0.001). Interaction: interval and condition (p=0.004).||Soundfield localization of 200-ms speech-shaped noise, presented from 11 speakers at 60, 70, or 80 decibel (dB) sound pressure level (SPL) in a sound treated room. Overall root-mean-square (RMS) error is the difference between the sound source azimuth and the response azimuth and a lower score indicates more accurate localization of the sound source. A repeated-measures ANOVA evaluated the effects of interval, condition (unaided or with the cochlear implant), and their interaction.||||<0.012
72535481|NCT02203305|144600488|SUPERIORITY||||||<|0.001||||||A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity.|ANOVA|||Soundfield localization of 200-ms speech-shaped noise, presented from 11 speakers at 60, 70, or 80 decibel (dB) sound pressure level (SPL) in a sound treated room. Overall root-mean-square (RMS) error is the difference between the sound source azimuth and the response azimuth and a lower score indicates more accurate localization of the sound source. A repeated-measures ANOVA evaluated the effect of interval (pre-operatively, 1, 3, 6, 9, and 12 months post). Pre-op: unaided, Post: bilateral.||||<0.001
72535482|NCT02203305|144600488|SUPERIORITY||||||<|0.001||||||A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity.|ANOVA|||Soundfield localization of 200-ms speech-shaped noise, presented from 11 speakers at 60, 70, or 80 decibel (dB) sound pressure level (SPL) in a sound treated room. Overall root-mean-square (RMS) error is the difference between the sound source azimuth and the response azimuth and a lower score indicates more accurate localization of the sound source. A repeated-measures ANOVA evaluated the effects of interval (pre-operatively, 1, 3, 6, 9, and 12 months post). Pre-op: unaided, Post: bilateral.||||<0.001
72535483|NCT02203305|144600488|OTHER|correlation|bivariate pearson correlation|0.42|||=|0.033|TWO_SIDED||||||bivariate pearson correlation|||Association of age at implantation and sound source localization (RMS) at the 12-month interval with the cochlear implant, analyzed with a Bivariate Pearson correlation (one-tailed).||||=0.033
72535484|NCT02203305|144600488|SUPERIORITY||||||<|0.249||||||There were significant main effects of group (p\<0.001) and interval (p\<0.001). There was a non-significant interaction between group and interval (p=0.249).|Mixed Models Analysis|Main effects: group (p\<0.001) and interval (p\<0.001). Interaction: group and interval (p=0.249).||Comparison of sound source localization between groups (UHL/SSD and AHL) over the post-activation intervals (1, 3, 6, 9, and 12 months).||||<0.249
72535485|NCT02203305|144600489|SUPERIORITY||||||<|0.001||||||A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity.|ANOVA|||Responses on the Speech, Spatial, \& Qualities of hearing scale (SSQ) as measured with the total score were compared over the post-activation period (i.e., 1, 3, 6, 9, and 12 months).||||<0.001
72408425|NCT02188485|144325275|SUPERIORITY||Mean Difference (Final Values)|-0.34|STANDARD_ERROR_OF_MEAN|0.52||0.511|TWO_SIDED||||||Mixed Models Analysis||This mean difference is not identical to the mean difference presented in the summary table because this mean difference was adjusted for random effects in the model.|||||.511
72408426|NCT02188485|144325276|SUPERIORITY||Mean Difference (Final Values)|-2.47|STANDARD_ERROR_OF_MEAN|0.85||0.014|TWO_SIDED||||||Mixed Models Analysis||This mean difference is not identical to the mean difference presented in the summary table because this mean difference was adjusted for random effects in the model.|||||.014
72408427|NCT01556204|144325303|SUPERIORITY_OR_OTHER|||||||0.71||||||This p-value is from a single comparison between two arms for operative time.|t-test, 2 sided|||Variance estimates for this power analysis were taken from Nezhat C, et al, 2010. We determined that 37 subjects in each arm were needed to detect a difference of ≥ 32 minutes in operating time between conventional and robotic surgery for endometriosis with 80% power and a significance level of 0.05.||||0.71
72408428|NCT01556204|144325304|SUPERIORITY_OR_OTHER|||||||0.53||||||This applies to Row title: Baseline|Mixed Models Analysis|||Secondary analysis for pain at baseline for robotic vs conventional laparoscopy for endometriosis.||||0.53
72535486|NCT02203305|144600489|SUPERIORITY||||||=|0.056||||||A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity.|ANOVA|||Responses on the SSQ as measured with the total score were compared over the post-activation period (i.e., 1, 3, 6, 9, and 12 months).||||=0.056
72535487|NCT02203305|144600489|SUPERIORITY||||||<|0.448||||||A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity.|Mixed Models Analysis|Main effects: interval (p\<0.001) and subscale (p\<0.001). Interaction: interval and subscale (p=0.488).||Responses on the SSQ over the post-activation period (i.e., 1, 3, 6, 9, and 12 months). Subscales include: speech, spatial, and qualities of hearing. A repeated-measures ANOVA compared the main effects of interval and subscale and their interaction over time with the cochlear implant (1, 3, 6, 9, and 12 months post-activation).||||<0.448
72535488|NCT02203305|144600489|SUPERIORITY||||||<|0.299||||||A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity.|Mixed Models Analysis|Main effects: subscale (p\<0.001) and interval (p=0.072). Interaction: subscale and interval (p=0.299).||Responses on the SSQ over the post-activation period (i.e., 1, 3, 6, 9, and 12 months). Subscales include: speech, spatial, and qualities of hearing. A repeated-measures ANOVA compared the main effects of interval and subscale and their interaction over time with the cochlear implant (1, 3, 6, 9, and 12 months post-activation).||||<0.299
72535489|NCT02203305|144600489|SUPERIORITY||||||<|0.018||||||There were significant main effects of interval (p\<0.001) and pragmatic subscale (p\<0.001), and their interaction (p\<0.018).|Mixed Models Analysis|Main effects: interval (p\<0.001) and pragmatic subscale (p\<0.001). Interaction: interval and pragmatic subscale (p\<0.018).||Responses on the SSQ Speech pragmatic subscale over the post-activation period (i.e., 1, 3, 6, 9, and 12 months). A repeated-measures ANOVA compared the main effects of interval and pragmatic subscale and their interaction over time with the cochlear implant (1, 3, 6, 9, and 12 months post-activation).||||<0.018
72535490|NCT02203305|144600489|SUPERIORITY||||||<|0.767|||||||Mixed Models Analysis|Main effects: interval (p\<0.001) and pragmatic subscale (p=0.767). Interaction: interval and pragmatic subscale (p=0.542).||Responses on the SSQ Spatial pragmatic subscale over the post-activation period (i.e., 1, 3, 6, 9, and 12 months). A repeated-measures ANOVA compared the main effects of interval and pragmatic subscale and their interaction over time with the cochlear implant (1, 3, 6, 9, and 12 months post-activation).||||<0.767
72535491|NCT02203305|144600489|SUPERIORITY||||||<|0.242|||||||Mixed Models Analysis|Main effects: interval (p=0.003) and pragmatic subscale (p\<0.001). Interaction: interval and pragmatic subscale (p=0.242).||Responses on the SSQ Qualities of Hearing pragmatic subscale over the post-activation period (i.e., 1, 3, 6, 9, and 12 months). A repeated-measures ANOVA compared the main effects of interval and pragmatic subscale and their interaction over time with the cochlear implant (1, 3, 6, 9, and 12 months post-activation).||||<0.242
72535492|NCT02203305|144600489|OTHER|Bivariate pearson correlation||||||0.37|||||||bivariate pearson correlation|||Association of subjective benefit (Speech Subscale) at the preoperative interval and speech recognition with AzBio sentences when the target is from the front and the masker is towards the acoustic ear.||||0.370
72535493|NCT02203305|144600489|OTHER|bivariate pearson correlation|||||=|0.865||||||Percent correct data were converted to rationalized arcsine units (RAU) prior to data analysis.|bivariate pearson correlation|||Association of subjective benefit (Speech Subscale) at the preoperative interval and speech recognition with AzBio sentences when the target is from the front and the masker is towards the acoustic ear.||||=0.865
72535494|NCT02203305|144600489|OTHER|bivariate pearson correlation|bivariate pearson correlation|0.6|||=|0.005|TWO_SIDED|||||Percent correct data were converted to rationalized arcsine units (RAU) prior to data analysis.|bivariate pearson correlation|||Association of subjective benefit (Speech Subscale) at the 12-month interval and speech recognition with AzBio sentences when the target is from the front and the masker is towards the acoustic ear.||||=0.005
72535495|NCT02203305|144600489|OTHER|bivariate pearson correlation|bivariate pearson correlation|0.67|||=|0.006|TWO_SIDED|||||Percent correct data were converted to rationalized arcsine units (RAU) prior to data analysis.|bivariate pearson correlation|||Association of subjective benefit (Speech Subscale) at the 12-month interval and speech recognition with AzBio sentences when the target is from the front and the masker is towards the acoustic ear.||||=0.006
72535496|NCT02203305|144600489|OTHER|bivariate pearson correlation|bivariate pearson correlation|-0.33|||=|0.152|TWO_SIDED||||||bivariate pearson correlation|||Association of subjective benefit (Spatial Subscale) at the preoperative interval and sound source localization (RMS error).||||=0.152
72535497|NCT02203305|144600489|OTHER|bivariate pearson correlation|||||=|0.761|||||||bivariate pearson correlation|||Association of subjective benefit (Spatial Subscale) at the preoperative interval and sound source localization (RMS error).||||=0.761
72535498|NCT02203305|144600489|OTHER|bivariate pearson correlation|||||=|0.315|||||||bivariate pearson correlation|||Association of subjective benefit (Spatial Subscale) at the 12-month interval and sound source localization (RMS error).||||=0.315
72535499|NCT02203305|144600489|OTHER|bivariate pearson correlation|||||=|0.666|||||||bivariate pearson correlation|||Association of subjective benefit (Spatial Subscale) at the 12-month interval and sound source localization (RMS error).||||=0.666
72573044|NCT03118570|144673084|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.086||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 12||||0.086
72573045|NCT03118570|144673084|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.245||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 12||||0.245
72573046|NCT03118570|144673084|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.232||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 12||||0.232
72573047|NCT03118570|144673084|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.237||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 18||||0.237
72408429|NCT01556204|144325304|SUPERIORITY_OR_OTHER|||||||0.53||||||This applies to Row title: 6-weeks|Mixed Models Analysis|||Pain scores at 6 weeks comparison between robotic and laparoscopy.||||0.53
72535500|NCT02203305|144600489|SUPERIORITY||||||>|0.175|||||||Mixed Models Analysis|Main effects: cohort (p=0.912), interval (p=0.463), and subscale (p=0.483). Interactions: 2-way or 3-way (p\>0.175).||Comparison of subjective benefit between groups (UHL/SSD and AHL) on the speech, spatial, and qualities of hearing subscales during the post-activation intervals (1, 3, 6, 9, and 12 months).||||>0.175
72535501|NCT02203305|144600490|SUPERIORITY||||||<|0.161||||||"Significant effect of interval (p=0.046) and of condition (p\<0.001) and a non-significant interaction (p=0.161).~Percent correct data were converted to rationalized arcsine units (RAU) prior to data analysis."|Mixed Models Analysis|Main effects: interval (p=0.046) and condition (p\<0.001). Interaction: interval and condition (p=0.161).||Recorded AzBio sentences in a 10-talker masker were evaluated in 2 conditions: 1) unaided and 2) with the cochlear implant (CI) over the post-activation study period. A repeated-measures ANOVA evaluated the main effects of interval (1, 3, 6, 9, and 12 months post-activation), condition (unaided or with the CI), and their interaction.||||<0.161
72535502|NCT02203305|144600490|SUPERIORITY||||||>|0.107||||||"Significant effect of condition (p\<0.001) and the interaction (p\<0.001). Non-significant effect of interval (p=0.107).~Percent correct data were converted to rationalized arcsine units (RAU) prior to data analysis."|Mixed Models Analysis|Main effects: condition (p\<0.001) and interval p=0.107). Interaction of condition and interval (p\<0.001).||Recorded AzBio sentences in a 10-talker masker were evaluated in 2 conditions: 1) unaided and 2) with the cochlear implant (CI) over the post-activation study period. A repeated-measures ANOVA evaluated the main effects of interval (1, 3, 6, 9, and 12 months post-activation), condition (unaided or with the CI), and their interaction.||||>0.107
72535503|NCT02203305|144600490|SUPERIORITY||||||<|0.001||||||Percent correct data were converted to rationalized arcsine units (RAU) prior to data analysis.|ANOVA|||Recorded AzBio sentences in a 10-talker masker were evaluated in an unaided condition for the poorer hearing ear pre-operatively and with the cochlear implant (CI) over the study period. A repeated-measures ANOVA evaluated the main effect of interval (before surgery, and 1, 3, 6, 9, and 12 months post-activation). Percent correct converted to RAU.||||<0.001
72535504|NCT02203305|144600490|SUPERIORITY||||||<|0.001||||||Percent correct data were converted to rationalized arcsine units (RAU) prior to data analysis.|ANOVA|||Recorded AzBio sentences in a 10-talker masker were evaluated in an unaided condition for the poorer hearing ear pre-operatively and with the cochlear implant (CI) over the study period. A repeated-measures ANOVA evaluated the main effect of interval (before surgery, and 1, 3, 6, 9, and 12 months post-activation). Percent correct converted to RAU.||||<0.001
72535505|NCT02203305|144600490|OTHER|bivariate pearson correlation|||||=|0.58||||||Percent correct data were converted to rationalized arcsine units (RAU) prior to data analysis.|bivariate pearson correlation|||Association of age at implantation and speech recognition in noise at the 12-month interval with the cochlear implant, analyzed with a Bivariate Pearson correlation.||||=0.580
72535506|NCT02203305|144600490|SUPERIORITY||||||<|0.743||||||A logit transformation was applied to proportion correct data prior to analysis.|Mixed Models Analysis|Effects: SNR (p=0.026) \& masker condition (p\<0.001). Interactions: cohort \& condition (p\<0.001), interval \& condition (p=0.015). Others (p\>0.140).||Comparison of speech recognition between groups (UHL/SSD and AHL) for the three masker configurations (noise towards the better hearing ear, noise towards the poorer hearing ear, and noise from the front) and signal-to-noise ratio (SNR; 0, 5, or 10 dB SNR) over the post-activation intervals (1, 3, 6, 9, and 12 months).||||<0.743
72535507|NCT02203305|144600490|OTHER|pearson correlation|||||=|0.036||||||Percent correct converted to rationalized arcsine units (RAU) prior to analysis.|bivariate pearson correlation|||Association of word recognition and speech recognition in noise, analyzed with a Bivariate Pearson correlation. Scores were averaged between 3 and 12 months post-activation as an estimate of asymptotic performance.||||=0.036
72535508|NCT02203305|144600491|SUPERIORITY||||||<|0.183||||||A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity.|Mixed Models Analysis|Main effect: interval (p=0.183) and condition (p=0.012). Interaction: interval and condition (p=0.081).||Soundfield localization of 200-ms speech-shaped noise, presented from 11 speakers at 60, 70, or 80 decibel (dB) sound pressure level (SPL) in a sound treated room. Variable error is the average of the standard deviation of the responses for each source and a lower score reflects a more consistently accurate response. A repeated-measures ANOVA evaluated the effects of interval, condition (unaided or with the cochlear implant), and their interaction.||||<0.183
72535509|NCT02203305|144600491|SUPERIORITY||||||<|0.196||||||A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity.|Mixed Models Analysis|Main effect: interval (p=0.010) and condition (p=0.100). Interaction: interval and condition (p=0.196).||Soundfield localization of 200-ms speech-shaped noise, presented from 11 speakers at 60, 70, or 80 decibel (dB) sound pressure level (SPL) in a sound treated room. Variable error is the average of the standard deviation of the responses for each source and a lower score reflects a more consistently accurate response. A repeated-measures ANOVA evaluated the effects of interval, condition (unaided or with the cochlear implant), and their interaction.||||<0.196
72408430|NCT01556204|144325304|SUPERIORITY_OR_OTHER|||||||0.48||||||This applies to Row title: 6-months|Mixed Models Analysis|||Pain scores at 6 months for robotic vs laparoscopy.||||0.48
72408431|NCT04099524|144325328|SUPERIORITY|The analysis was based on evaluating whether active tDCS is superior than sham tDCS on outcomes.|Mean Difference (Final Values)|-0.18|||<|0.05|TWO_SIDED|||||multiple correction adjusted p\<0.05|Mixed Models Analysis|||p-value was calculated, and is not attempting to indicate the threshold for statistical significance.||||<0.05
72535510|NCT02203305|144600491|SUPERIORITY|||||||0.056||||||A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity.|ANOVA|||Soundfield localization of 200-ms speech-shaped noise, presented from 11 speakers at 60, 70, or 80 decibel (dB) sound pressure level (SPL) in a sound treated room. Variable error is the average of the standard deviation of the responses for each source and a lower score reflects a more consistently accurate response. A repeated-measures ANOVA evaluated the effect of interval (pre-operatively, 1, 3, 6, 9, and 12 months post). Pre-op: unaided, Post: bilateral.||||0.056
72573048|NCT03118570|144673084|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.088||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 18||||0.088
72408432|NCT04099524|144325328|SUPERIORITY||Mean Difference (Final Values)|0.2|||<|0.05|TWO_SIDED|||||multiple correction adjusted p\<0.05|Mixed Models Analysis|||||||<0.05
72535511|NCT02203305|144600491|SUPERIORITY||||||=|0.21||||||A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity.|ANOVA|||Soundfield localization of 200-ms speech-shaped noise, presented from 11 speakers at 60, 70, or 80 decibel (dB) sound pressure level (SPL) in a sound treated room. Variable error is the average of the standard deviation of the responses for each source and a lower score reflects a more consistently accurate response. A repeated-measures ANOVA evaluated the effects of interval (pre-operatively, 1, 3, 6, 9, and 12 months post). Pre-op: unaided, Post: bilateral.||||=0.210
72535512|NCT02203305|144600492|SUPERIORITY||||||<|0.071||||||A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity.|Mixed Models Analysis|Main effects: interval (p\<0.071) and condition (p\<0.001). Interaction: interval and condition (p\<0.051)||Soundfield localization of 200-ms speech-shaped noise, presented from 11 speakers at 60, 70, or 80 decibel (dB) sound pressure level (SPL) in a sound treated room. Constant error is a measure of side bias, and a lower score indicates less response bias to either side. A repeated-measures ANOVA evaluated the effects of interval, condition (unaided or with the cochlear implant), and their interaction.||||<0.071
72535513|NCT02203305|144600492|SUPERIORITY||||||<|0.109||||||A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity.|Mixed Models Analysis|Main effects: interval (p=0.109) and condition (p\<0.001). Interaction: interval and condition (p=0.052).||Soundfield localization of 200-ms speech-shaped noise, presented from 11 speakers at 60, 70, or 80 decibel (dB) sound pressure level (SPL) in a sound treated room. Constant error is a measure of side bias, and a lower score indicates less response bias to either side. A repeated-measures ANOVA evaluated the effects of interval, condition (unaided or with the cochlear implant), and their interaction.||||<0.109
72535514|NCT02203305|144600492|SUPERIORITY||||||<|0.001||||||A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity.|ANOVA|||Soundfield localization of 200-ms speech-shaped noise, presented from 11 speakers at 60, 70, or 80 decibel (dB) sound pressure level (SPL) in a sound treated room. Constant error is a measure of side bias, and a lower score indicates less response bias to either side. A repeated-measures ANOVA evaluated the effect of interval (pre-operatively, 1, 3, 6, 9, and 12 months post). Pre-op: unaided, Post: bilateral.||||<0.001
72535515|NCT02203305|144600492|SUPERIORITY||||||<|0.001||||||A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity.|ANOVA|||Soundfield localization of 200-ms speech-shaped noise, presented from 11 speakers at 60, 70, or 80 decibel (dB) sound pressure level (SPL) in a sound treated room. Constant error is a measure of side bias, and a lower score indicates less response bias to either side. A repeated-measures ANOVA evaluated the effects of interval (pre-operatively, 1, 3, 6, 9, and 12 months post). Pre-op: unaided, Post: bilateral.||||<0.001
72535516|NCT02203305|144600493|SUPERIORITY||||||<|0.024||||||A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity.|Mixed Models Analysis|Main effects: interval (p=0.018) and condition (p\<0.001). Interaction: interval and condition (p=0.024).||Soundfield localization of 200-ms speech-shaped noise, presented from 11 speakers at 60, 70, or 80 decibel (dB) sound pressure level (SPL) in a sound treated room. Adjusted constant error is a measure of reliability in the response taking side bias into account, and a lower score indicates a more reliable response. A repeated-measures ANOVA evaluated the effects of interval, condition (unaided or with the cochlear implant), and their interaction.||||<0.024
72535517|NCT02203305|144600493|SUPERIORITY||||||<|0.219|||||||Mixed Models Analysis|Main effects: interval (p=0.187) and condition (p\<0.001). Interaction: interval and condition (p=0.219).||Soundfield localization of 200-ms speech-shaped noise, presented from 11 speakers at 60, 70, or 80 decibel (dB) sound pressure level (SPL) in a sound treated room. Adjusted constant error is a measure of reliability in the response taking side bias into account, and a lower score indicates a more reliable response. A repeated-measures ANOVA evaluated the effects of interval, condition (unaided or with the cochlear implant), and their interaction.||||<0.219
72535518|NCT02203305|144600493|SUPERIORITY||||||<|0.001||||||A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity.|ANOVA|||Soundfield localization of 200-ms speech-shaped noise, presented from 11 speakers at 60, 70, or 80 decibel (dB) sound pressure level (SPL) in a sound treated room. Adjusted constant error is a measure of reliability in the response taking side bias into account, and a lower score indicates a more reliable response. A repeated-measures ANOVA evaluated the effect of interval (pre-operatively, 1, 3, 6, 9, and 12 months post). Pre-op: unaided, Post: bilateral.||||<0.001
72573049|NCT03118570|144673084|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.302||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 18||||0.302
72573050|NCT03118570|144673084|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.626||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 24||||0.626
72573051|NCT03118570|144673084|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.517||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 8||||0.517
72573052|NCT03118570|144673084|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.262||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 24||||0.262
72573053|NCT03118570|144673085|SUPERIORITY|Comparison is between the Visit and Baseline|||||<|0.001||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 6||||< 0.001
72408433|NCT04099524|144325329|SUPERIORITY|The analysis was based on evaluating whether active tDCS is superior than sham tDCS on outcomes.|chi-square|3.14|||<|0.05|TWO_SIDED||||||Chi-squared|||reported p-value was calculated, and is not attempting to indicate the threshold for statistical significance.||||<0.05
72408434|NCT04099524|144325330|SUPERIORITY|The analysis was based on evaluating whether active tDCS is superior than sham tDCS on outcomes.|Mean Difference (Final Values)|0.2|||<|0.05|TWO_SIDED|||||multiple correction adjusted p\<0.05|Mixed Models Analysis|||p-value was calculated, and is not attempting to indicate the threshold for statistical significance.||||<0.05
72408435|NCT04099524|144325331|SUPERIORITY|The analysis was based on evaluating whether active tDCS is superior than sham tDCS on outcomes.|Mean Difference (Final Values)|0.84|||<|0.05|TWO_SIDED||||||Mixed Models Analysis|||reported p-value was calculated, and is not attempting to indicate the threshold for statistical significance||||<0.05
72535519|NCT02203305|144600493|SUPERIORITY||||||<|0.001||||||A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity.|ANOVA|||Soundfield localization of 200-ms speech-shaped noise, presented from 11 speakers at 60, 70, or 80 decibel (dB) sound pressure level (SPL) in a sound treated room. Adjusted constant error is a measure of reliability in the response taking side bias into account, and a lower score indicates a more reliable response. A repeated-measures ANOVA evaluated the effects of interval (pre-operatively, 1, 3, 6, 9, and 12 months post). Pre-op: unaided, Post: bilateral.||||<0.001
72535520|NCT02203305|144600494|SUPERIORITY||||||=|0.011||||||A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity.|ANOVA|||Responses on the Abbreviated Profile of Hearing Aid Benefit (APHAB) as measured with the global score were compared over the post-activation period (i.e., 1, 3, 6, 9, and 12 months).||||=0.011
72535521|NCT02203305|144600494|SUPERIORITY||||||=|0.264||||||A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity.|ANOVA|||The Abbreviated Profile of Hearing Aid Benefit, participants rank their perceived difficulty on a scale of 1-99, with lower values indicate less perceived difficulty. The global score is calculated from the responses on the ease of communication, reverberation, and effectiveness in background noise subscales. Responses were compared to responses over the post-activation period (1, 3, 6, 9, and 12 months) with the cochlear implant using a repeated-measures ANOVA.||||=0.264
72535522|NCT02203305|144600494|SUPERIORITY||||||<|0.023||||||A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity.|Mixed Models Analysis|Main effects: interval (p=0.005) and subscales (p=0.001). Interaction: interval and subscales (p=0.023).||The Abbreviated Profile of Hearing Aid Benefit, participants rank their perceived difficulty on a scale of 1-99, with lower values indicate less perceived difficulty. Subscales include: ease of communication, reverberation, effectiveness in background noise, and reverberation. A repeated-measures ANOVA compared the main effects of interval and subscale and their interaction over time with the cochlear implant (1, 3, 6, 9, and 12 months post-activation).||||<0.023
72535523|NCT02203305|144600494|SUPERIORITY||||||<|0.643|||||||Mixed Models Analysis|Main effects: interval (p=0.643) and subscale (p=0.005). Interaction: interval and subscale (p=0.480).||The Abbreviated Profile of Hearing Aid Benefit, participants rank their perceived difficulty on a scale of 1-99, with lower values indicate less perceived difficulty. Subscales include: ease of communication, reverberation, effectiveness in background noise, and reverberation. A repeated-measures ANOVA compared the main effects of interval and subscale and their interaction over time with the cochlear implant (1, 3, 6, 9, and 12 months post-activation).||||<0.643
72573054|NCT03118570|144673085|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.004||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 12||||0.004
72573055|NCT03118570|144673085|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.08||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 6||||0.080
72408436|NCT00298038|144325333|SUPERIORITY|Analysis based on the overall comparison of time to the first breakthrough overt HE episode between rifaximin and placebo groups adjusting for analysis region, using the Cox proportional hazards model (Score test, \[that is, Log rank test stratified by analysis region\]) with a 2-sided test at a significance level of 0.05 under the proportional hazards assumption.|Hazard Ratio (HR)|0.421|||<|0.0001|TWO_SIDED|95.0|0.276|0.641|||Cox proportional hazards model|||||0.641|0.276|<0.0001
72408437|NCT04733157|144325339|OTHER||Risk Ratio (RR)|0.87|STANDARD_ERROR_OF_MEAN|0.1||0.33|TWO_SIDED|95.0|0.69|1.09||Threshold for statistical significance was 0.05|Chi-squared|||||1.09|0.69|0.33
72408438|NCT02517905|144325366|SUPERIORITY||LSMD|-2.7||||0.8661|TWO_SIDED|95.0|-33.5|28.2|||ANOVA|||||28.2|-33.5|0.8661
72535524|NCT02203305|144600494|OTHER|bivariate pearson correlation (one-tailed)|||||=|0.947||||||Percent correct data were converted to rationalized arcsine units (RAU) prior to data analysis.|bivariate pearson correlation|||Association of subjective benefit (Noise Subscale) at the preoperative interval and speech recognition with AzBio sentences when the target is from the front and the masker is towards the acoustic ear.||||=0.947
72535525|NCT02203305|144600494|SUPERIORITY||||||=|0.5||||||Percent correct data were converted to rationalized arcsine units (RAU) prior to data analysis.|bivariate pearson correlation|||Association of subjective benefit (Noise Subscale) at the preoperative interval and speech recognition with AzBio sentences when the target is from the front and the masker is towards the acoustic ear.||||=0.500
72573056|NCT03118570|144673085|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.031||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 12||||0.031
72408439|NCT02517905|144325367|SUPERIORITY||LSMD|-4.0||||0.578|TWO_SIDED|95.0|-18.2|10.2|||ANOVA|||||10.2|-18.2|0.5780
72573057|NCT03118570|144673086|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.06||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 6||||0.060
72408440|NCT02517905|144325368|SUPERIORITY||LSMD|5.9||||0.801|TWO_SIDED|95.0|-40.2|52.1|||ANOVA|||||52.1|-40.2|0.8010
72573058|NCT03118570|144673086|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.015||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 6||||0.015
72573059|NCT03118570|144673086|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.795||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 6||||0.795
72573060|NCT03118570|144673086|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.011||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 12||||0.011
72573061|NCT03118570|144673086|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.047||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 12||||0.047
72573062|NCT03118570|144673086|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.756||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 12||||0.756
72573063|NCT03118570|144673086|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.006||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 18||||0.006
72573064|NCT03118570|144673086|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.137||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 18||||0.137
72408441|NCT02742103|144325382|OTHER||Rate difference (CSL112 - placebo)|-0.124|||||TWO_SIDED|95.0|-0.296|-0.005|||Newcombe-Wilson|||||-0.005|-0.296|
72408442|NCT02742103|144325383|OTHER||Rate difference (CSL112 - placebo)|-0.103|||||TWO_SIDED|95.0|-0.277|0.025|||Newcombe-Wilson|||||0.025|-0.277|
72535526|NCT02203305|144600494|OTHER|bivariate pearson correlation|bivariate pearson correlation|-0.51|||=|0.023|TWO_SIDED|||||Percent correct data were converted to rationalized arcsine units (RAU) prior to data analysis.|bivariate pearson correlation|||Association of subjective benefit (Noise Subscale) at the 12-month interval and speech recognition with AzBio sentences when the target is from the front and the masker is towards the acoustic ear.||||=0.023
72535527|NCT02203305|144600494|OTHER|bivariate pearson correlation|bivariate pearson correlation|-0.55|||=|0.033|TWO_SIDED|||||Percent correct data were converted to rationalized arcsine units (RAU) prior to data analysis.|bivariate pearson correlation|||Association of subjective benefit (Noise Subscale) at the 12-month interval and speech recognition with AzBio sentences when the target is from the front and the masker is towards the acoustic ear.||||=0.033
72535528|NCT02203305|144600494|SUPERIORITY||||||>|0.208|||||||Mixed Models Analysis|Main effects: cohort (p=0.541), interval (p=0.446), and subscale (p=0.208). Interactions: 2-way or 3-way (p\>0.287).||Comparison of subjective benefit between groups (UHL/SSD and AHL) on the ease of communication, background noise, and reverberation subscales over the post-activation intervals (1, 3, 6, 9, and 12 months).||||>0.208
72535529|NCT02203305|144600495|SUPERIORITY||||||=|0.221||||||A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity.|ANOVA|||"The Tinnitus Handicap Inventory is a 25-item questionnaire. The subject answers yes (4 points), sometimes (2 points), or no (0 points) to each question. Responses are added to quantify tinnitus severity: none/slight (0-16), mild (18-36), moderate (38-56), severe (58-76), and catastrophic (78-100). Responses were compared over the post-activation time period (1, 3, 6, 9, and 12 months)."||||=0.221
72535530|NCT02203305|144600495|SUPERIORITY||||||=|0.538||||||A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity.|ANOVA|||"The Tinnitus Handicap Inventory is a 25-item questionnaire. The subject answers yes (4 points), sometimes (2 points), or no (0 points) to each question. Responses are added to quantify tinnitus severity: none/slight (0-16), mild (18-36), moderate (38-56), severe (58-76), and catastrophic (78-100). Responses were compared over the post-activation time period (1, 3, 6, 9, and 12 months)."||||=0.538
72535531|NCT02203305|144600495|SUPERIORITY||||||>|0.218||||||There were no significant main effects of cohort (p=0.265) or interval (p=0.430). There was no significant interaction between cohort and interval (p=0.218).|Mixed Models Analysis|Main effects: cohort (p=0.265) or interval (p=0.430). Interaction: cohort and interval (p=0.218).||Comparison of subjective benefit between groups (UHL/SSD and AHL) on the Tinnitus Handicap Inventory over the post-activation intervals (1, 3, 6, 9, and 12 months).||||>0.218
72573065|NCT03118570|144673086|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.639||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 18||||0.639
72573066|NCT03118570|144673086|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.325||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 24||||0.325
72573067|NCT03118570|144673086|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.108||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 24||||0.108
72408443|NCT02573324|144325419|SUPERIORITY||Cox Proportional Hazard|1.02||||0.633|TWO_SIDED|95.0|0.82|1.26||Weighted log-rank P-value: Stratified Fleming-Harrington (ρ = 0, γ = 0.2) test was used. Stratified by randomization stratification factors namely: MGMT methylation status, RPA class, region of the world and EGFRvIII mutation status.|Log Rank||Based on multivariate Cox proportional hazards model including treatment, MGMT methylation status, RPA class, region of the world, and EGFRvIII mutation status as covariates.|Terms abbreviated below: O6-methylguaninemethlytransferese (MGMT); Recursive Partitioning Analysis (RPA); EGFRde2-7 (EGFRvIII)||1.26|0.82|0.633
72535532|NCT02203305|144600496|SUPERIORITY||||||<|0.322||||||Percent correct data were converted to rationalized arcsine units (RAU) prior to data analysis.|Mixed Models Analysis|Main effect: interval (p=0.084) and condition (p=0.322). Interaction: interval and condition (p=0.125).||Recorded AzBio sentences in a 10-talker masker were evaluated in 2 conditions: 1) unaided and 2) with the cochlear implant (CI) over the post-activation study period. A repeated-measures ANOVA evaluated the main effects of interval (1, 3, 6, 9, and 12 months post-activation), condition (unaided or with the CI), and their interaction.||||<0.322
72535533|NCT02203305|144600496|SUPERIORITY||||||<|0.317||||||Percent correct data were converted to rationalized arcsine units (RAU) prior to data analysis.|Mixed Models Analysis|Main effects: interval (p=0.014) and condition (p=0.317). Interaction: interval and condition (p=0.118).||Recorded AzBio sentences in a 10-talker masker were evaluated in 2 conditions: 1) unaided and 2) with the cochlear implant (CI) over the post-activation study period. A repeated-measures ANOVA evaluated the main effects of interval (1, 3, 6, 9, and 12 months post-activation), condition (unaided or with the CI), and their interaction.||||<0.317
72535534|NCT02203305|144600496|SUPERIORITY||||||=|0.017||||||Percent correct data were converted to rationalized arcsine units (RAU) prior to data analysis.|ANOVA|||Recorded AzBio sentences in a 10-talker masker were evaluated in an unaided condition for the poorer hearing ear pre-operatively and with the cochlear implant (CI) over the study period. A repeated-measures ANOVA evaluated the main effect of interval (before surgery, and 1, 3, 6, 9, and 12 months post-activation). Percent correct converted to RAU.||||=0.017
72535535|NCT02203305|144600496|SUPERIORITY||||||=|0.292||||||Percent correct data were converted to rationalized arcsine units (RAU) prior to data analysis.|ANOVA|||Recorded AzBio sentences in a 10-talker masker were evaluated in an unaided condition for the poorer hearing ear pre-operatively and with the cochlear implant (CI) over the study period. A repeated-measures ANOVA evaluated the main effect of interval (before surgery, and 1, 3, 6, 9, and 12 months post-activation). Percent correct converted to RAU.||||=0.292
72535536|NCT02203305|144600496|OTHER|pearson correlation|||||>|0.185|||||||bivariate pearson correlation|||Association of word recognition and speech recognition in noise, analyzed with a Bivariate Pearson correlation. Scores were averaged between 3 and 12 months post-activation as an estimate of asymptotic performance.||||>0.185
72573068|NCT03118570|144673086|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.078||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 24||||0.078
72573069|NCT03118570|144673086|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.106||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 6||||0.106
72573070|NCT03118570|144673086|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.236||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 6||||0.236
72573071|NCT03118570|144673086|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.164||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 6||||0.164
72535537|NCT02203305|144600497|SUPERIORITY||||||<|0.581||||||Percent correct data were converted to rationalized arcsine units (RAU) prior to data analysis.|Mixed Models Analysis|Main effect: interval (p=0.039) and condition (p=0.007). Interaction: interval and condition (p=0.581).||Recorded AzBio sentences in a 10-talker masker were evaluated in 2 conditions: 1) unaided and 2) with the cochlear implant (CI) over the post-activation study period. A repeated-measures ANOVA evaluated the main effects of interval (1, 3, 6, 9, and 12 months post-activation), condition (unaided or with the CI), and their interaction.||||<0.581
72535538|NCT02203305|144600497|SUPERIORITY||||||<|0.817||||||Percent correct data were converted to rationalized arcsine units (RAU) prior to data analysis.|Mixed Models Analysis|Main effects: condition (p=0.005) and interval (p=0.528). Interaction: condition and interval (p=0.817).||Recorded AzBio sentences in a 10-talker masker were evaluated in 2 conditions: 1) unaided and 2) with the cochlear implant (CI) over the post-activation study period. A repeated-measures ANOVA evaluated the main effects of interval (1, 3, 6, 9, and 12 months post-activation), condition (unaided or with the CI), and their interaction.||||<0.817
72408444|NCT02573324|144325419|SUPERIORITY|||||||0.704||||||Log-rank P-value (1-sided): Stratified by randomization stratification factors namely: MGMT methylation status, RPA class, region of the world and EGFRvIII mutation status.|Log Rank|||||||0.704
72408445|NCT02573324|144325420|SUPERIORITY||Cox Proportional Hazard|0.97||||0.504|TWO_SIDED|95.0|0.76|1.24||Weighted log-rank P-value: Stratified Fleming-Harrington (ρ = 0, γ = 0.2) test was used. Stratified by randomization stratification factors namely: MGMT methylation status, RPA class, region of the world and EGFRvIII mutation status.|Log Rank||Based on multivariate Cox proportional hazards model including treatment, MGMT methylation status, RPA class, region of the world, and EGFRvIII mutation status as covariates.|||1.24|0.76|0.504
72408446|NCT02573324|144325420|SUPERIORITY|||||||0.599||||||Log-rank P-value (1-sided): Stratified by randomization stratification factors namely: MGMT methylation status, RPA class, region of the world and EGFRvIII mutation status.|Log Rank|||||||0.599
72535539|NCT02203305|144600497|SUPERIORITY||||||=|0.008||||||A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity.|ANOVA|||Recorded AzBio sentences in a 10-talker masker were evaluated in an unaided condition for the poorer hearing ear pre-operatively and with the cochlear implant (CI) over the study period. A repeated-measures ANOVA evaluated the main effect of interval (before surgery, and 1, 3, 6, 9, and 12 months post-activation). Percent correct converted to RAU.||||=0.008
72535540|NCT02203305|144600497|SUPERIORITY||||||=|0.009|||||||ANOVA|||Recorded AzBio sentences in a 10-talker masker were evaluated in an unaided condition for the poorer hearing ear pre-operatively and with the cochlear implant (CI) over the study period. A repeated-measures ANOVA evaluated the main effect of interval (before surgery, and 1, 3, 6, 9, and 12 months post-activation). Percent correct converted to RAU.||||=0.009
72535541|NCT02203305|144600497|OTHER|bivariate correlation|||||=|0.049||||||"Percent correct data were converted to rationalized arcsine units (RAU) prior to data analysis.~This correlation was no longer significant when controlling for the hearing threshold at 8000 Hz."|bivariate pearson correlation|||Association of age at implantation and performance at the 12-month interval with the cochlear implant, analyzed with a Bivariate Pearson correlation (one-tailed).||||=0.049
72535542|NCT02203305|144600497|OTHER|pearson correlation|||||>|0.185|||||||bivariate pearson correlation|||Association of word recognition and speech recognition in noise, analyzed with a Bivariate Pearson correlation. Scores were averaged between 3 and 12 months post-activation as an estimate of asymptotic performance.||||>0.185
72535543|NCT02203305|144600498|SUPERIORITY||||||<|0.44|||||||Mixed Models Analysis|Main effects: interval (p=0.070) and condition (p=0.440). Interaction: interval and condition (p=0.047).||Recorded BKB sentences in a 4-talker masker were evaluated in 2 conditions: 1) unaided and 2) with the cochlear implant (CI) over the post-activation study period. Results are reported in dB SNR, where a lower value indicates better performance. A repeated-measures ANOVA evaluated the main effects of interval (1, 3, 6, 9, and 12 months post-activation), condition (unaided or with the CI), and their interaction.||||<0.440
72535544|NCT02203305|144600498|SUPERIORITY||||||<|0.379|||||||Mixed Models Analysis|Main effects: condition (p\<0.001) and interval (p=0.250). Interaction: interval and condition (p=0.379).||Recorded BKB sentences in a 4-talker masker were evaluated in 2 conditions: 1) unaided and 2) with the cochlear implant (CI) over the post-activation study period. Results are reported in dB SNR, where a lower value indicates better performance. A repeated-measures ANOVA evaluated the main effects of interval (1, 3, 6, 9, and 12 months post-activation), condition (unaided or with the CI), and their interaction.||||<0.379
72535545|NCT02203305|144600498|SUPERIORITY||||||=|0.021|||||||ANOVA|||Recorded BKB sentences in a 4-talker masker were evaluated in an unaided condition for the poorer hearing ear pre-operatively and with the cochlear implant (CI) over the study period. A repeated-measures ANOVA evaluated the main effect of interval (before surgery, and 1, 3, 6, 9, and 12 months post-activation).||||=0.021
72535546|NCT02203305|144600498|SUPERIORITY||||||<|0.001|||||||ANOVA|||Recorded BKB sentences in a 4-talker masker were evaluated in an unaided condition for the poorer hearing ear pre-operatively and with the cochlear implant (CI) over the study period. A repeated-measures ANOVA evaluated the main effect of interval (before surgery, and 1, 3, 6, 9, and 12 months post-activation).||||<0.001
72573072|NCT03118570|144673086|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.031||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 12||||0.031
72573073|NCT03118570|144673086|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.224||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 12||||0.224
72408447|NCT02573324|144325421|SUPERIORITY||Cox Proportional Hazard|1.17||||0.773|TWO_SIDED|95.0|0.76|1.8||Weighted log-rank P-value: Stratified Fleming-Harrington (ρ = 0, γ = 0.2) test was used. Stratified by randomization stratification factors namely: MGMT methylation status, RPA class, region of the world and EGFRvIII mutation status.|Log Rank||Based on multivariate Cox proportional hazards model including treatment, MGMT methylation status, RPA class, region of the world, and EGFRvIII mutation status as covariates.|||1.80|0.76|0.773
72408448|NCT02573324|144325421|SUPERIORITY|||||||0.74||||||Log-rank P-value (1-sided): Stratified by randomization stratification factors namely: MGMT methylation status, RPA class, region of the world and EGFRvIII mutation status.|Log Rank|||||||0.740
72408449|NCT02573324|144325422|SUPERIORITY||Cox Proportional Hazard|0.95||||0.381|TWO_SIDED|95.0|0.71|1.27||Weighted log-rank P-value: Stratified Fleming-Harrington (ρ = 0, γ = 0.2) test was used. Stratified by randomization stratification factors namely: MGMT methylation status, RPA class, region of the world and EGFRvIII mutation status.|Log Rank||Based on multivariate Cox proportional hazards model including treatment, MGMT methylation status, RPA class, region of the world and EGFRvIII mutation status as covariates.|||1.27|0.71|0.381
72408450|NCT02573324|144325422|SUPERIORITY|||||||0.409||||||Log-rank P-value (1-sided): Stratified by randomization stratification factors namely: MGMT methylation status, RPA class, region of the world and EGFRvIII mutation status.|Log Rank|||||||0.409
72408451|NCT02573324|144325423|SUPERIORITY||Cox Proportional Hazard|0.84||||0.029|TWO_SIDED|95.0|0.7|1.01||Stratified log-rank test was used. Stratified by randomization stratification factors namely: MGMT methylation status, RPA class, region of the world and EGFRvIII mutation status.|Log Rank||Based on multivariate Cox proportional hazards model including treatment, MGMT methylation status, RPA class, region of the world and EGFRvIII mutation status as covariates.|||1.01|0.70|0.029
72408452|NCT02573324|144325424|SUPERIORITY||Cox Proportional Hazard|0.72||||0.002|TWO_SIDED|95.0|0.56|0.93||Stratified log-rank test was used. Stratified by randomization stratification factors namely: MGMT methylation status, RPA class, region of the world and EGFRvIII mutation status.|Log Rank||Based on multivariate Cox proportional hazards model including treatment, MGMT methylation status, RPA class, region of the world and EGFRvIII mutation status as covariates.|||0.93|0.56|0.002
72535547|NCT02203305|144600499|SUPERIORITY||||||<|0.639||||||A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity.|Mixed Models Analysis|Main effect: condition (p\<0.001) and interval (p=0.639). Interaction: interval and condition (p=0.280).||Recorded BKB sentences in a 4-talker masker were evaluated in 2 conditions: 1) unaided and 2) with the cochlear implant (CI) over the post-activation study period. Results are reported in dB SNR, where a lower value indicates better performance. A repeated-measures ANOVA evaluated the main effects of interval (1, 3, 6, 9, and 12 months post-activation), condition (unaided or with the CI), and their interaction.||||<0.639
72535548|NCT02203305|144600499|SUPERIORITY||||||<|0.637|||||||Mixed Models Analysis|Main effects: condition (p\<0.001) and interval (p=0.637). Interaction: interval and condition (p=0.450).||Recorded BKB sentences in a 4-talker masker were evaluated in 2 conditions: 1) unaided and 2) with the cochlear implant (CI) over the post-activation study period. Results are reported in dB SNR, where a lower value indicates better performance. A repeated-measures ANOVA evaluated the main effects of interval (1, 3, 6, 9, and 12 months post-activation), condition (unaided or with the CI), and their interaction.||||<0.637
72535549|NCT02203305|144600499|SUPERIORITY||||||<|0.001||||||A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity.|ANOVA|||Recorded BKB sentences in a 4-talker masker were evaluated in an unaided condition for the poorer hearing ear pre-operatively and with the cochlear implant (CI) over the study period. A repeated-measures ANOVA evaluated the main effect of interval (before surgery, and 1, 3, 6, 9, and 12 months post-activation).||||<0.001
72535550|NCT02203305|144600499|SUPERIORITY||||||=|0.002|||||||ANOVA|||Recorded BKB sentences in a 4-talker masker were evaluated in an unaided condition for the poorer hearing ear pre-operatively and with the cochlear implant (CI) over the study period. A repeated-measures ANOVA evaluated the main effect of interval (before surgery, and 1, 3, 6, 9, and 12 months post-activation).||||=0.002
72535551|NCT02203305|144600500|SUPERIORITY||||||<|0.671|||||||Mixed Models Analysis|Main effects: interval (p=0.020) and condition (p=0.406). Interaction: interval and condition (p=0.671).||Recorded BKB sentences in a 4-talker masker were evaluated in 2 conditions: 1) unaided and 2) with the cochlear implant (CI) over the post-activation study period. Results are reported in dB SNR, where a lower value indicates better performance. A repeated-measures ANOVA evaluated the main effects of interval (1, 3, 6, 9, and 12 months post-activation), condition (unaided or with the CI), and their interaction.||||<0.671
72535552|NCT02203305|144600500|SUPERIORITY||||||>|0.124|||||||Mixed Models Analysis|Main effects: interval (p=0.124) and condition (p=0.845). Interaction: interval and condition (p=0.960).||Recorded BKB sentences in a 4-talker masker were evaluated in 2 conditions: 1) unaided and 2) with the cochlear implant (CI) over the post-activation study period. Results are reported in dB SNR, where a lower value indicates better performance. A repeated-measures ANOVA evaluated the main effects of interval (1, 3, 6, 9, and 12 months post-activation), condition (unaided or with the CI), and their interaction.||||>0.124
72535553|NCT02203305|144600500|SUPERIORITY||||||=|0.025|||||||ANOVA|||Recorded BKB sentences in a 4-talker masker were evaluated in an unaided condition for the poorer hearing ear pre-operatively and with the cochlear implant (CI) over the study period. A repeated-measures ANOVA evaluated the main effect of interval (before surgery, and 1, 3, 6, 9, and 12 months post-activation).||||=0.025
72535554|NCT02203305|144600500|SUPERIORITY||||||=|0.442|||||||ANOVA|||Recorded BKB sentences in a 4-talker masker were evaluated in an unaided condition for the poorer hearing ear pre-operatively and with the cochlear implant (CI) over the study period. A repeated-measures ANOVA evaluated the main effect of interval (before surgery, and 1, 3, 6, 9, and 12 months post-activation).||||=0.442
72535555|NCT02203305|144600501|SUPERIORITY||||||<|0.001||||||Percent correct values were converted to rationalized arcsine units prior to analysis.|t-test, 2 sided|||Paired samples t-test comparing word recognition (percent correct for CNC words) with a hearing aid at the pre-operative interval and the cochlear implant at the 12-month interval for the affected ear (masking presented to the contralateral ear).||||<0.001
72408453|NCT02573324|144325425|SUPERIORITY||Cox Proportional Hazard|1.329||||0.994|TWO_SIDED|95.0|1.087|1.626||Stratified log-rank test was used. Stratified by randomization stratification factors namely: MGMT methylation status, RPA class, region of the world and EGFRvIII mutation status.|Log Rank||Based on multivariate Cox proportional hazards model including treatment, MGMT methylation status, RPA class, region of the world and EGFRvIII mutation status as covariates.|||1.626|1.087|0.994
72408454|NCT02573324|144325426|SUPERIORITY||Cox Proportional Hazard|1.185||||0.938|TWO_SIDED|95.0|0.972|1.446||Stratified log-rank test was used. Stratified by randomization stratification factors namely: MGMT methylation status, RPA class, region of the world and EGFRvIII mutation status.|Log Rank||Based on multivariate Cox proportional hazards model including treatment, MGMT methylation status, RPA class, region of the world and EGFRvIII mutation status as covariates.|||1.446|0.972|0.938
72408455|NCT02573324|144325427|SUPERIORITY||Cox Proportional Hazard|1.136||||0.814|TWO_SIDED|95.0|0.921|1.402||Stratified log-rank test was used. Stratified by randomization stratification factors namely: MGMT methylation status, RPA class, region of the world and EGFRvIII mutation status.|Log Rank||Based on multivariate Cox proportional hazards model including treatment, MGMT methylation status, RPA class, region of the world and EGFRvIII mutation status as covariates.|||1.402|0.921|0.814
72408456|NCT02096835|144325460|SUPERIORITY_OR_OTHER|||||||0.021|TWO_SIDED||||||Chi-squared|||||||0.021
72408457|NCT02096835|144325461|SUPERIORITY_OR_OTHER|||||||0.021|TWO_SIDED||||||Chi-squared|||||||0.021
72408458|NCT02096835|144325462|SUPERIORITY_OR_OTHER|||||||0.503|TWO_SIDED||||||Chi-squared|||||||0.503
72408459|NCT02096835|144325463|SUPERIORITY_OR_OTHER|||||||0.571|TWO_SIDED||||||Chi-squared|||||||0.571
72408460|NCT03892889|144325465|OTHER||||||<|0.0001|TWO_SIDED|||||Paired t-test was used based on the prospective phase efficacy sample when applicable.|paired t-test|||||||<0.0001
72408461|NCT00023673|144325499|SUPERIORITY|||||||0.62|||||||Wilcoxon (Mann-Whitney)|2-sided significance level = 0.05||Lung toxicity (\<Grade 3 vs. \>= Grade 3): Lung V20||||0.62
72535556|NCT02203305|144600501|SUPERIORITY||||||<|0.001||||||Percent correct data were converted to rationalized arcsine units (RAU) prior to data analysis.|t-test, 2 sided|||Paired samples t-test comparing word recognition (percent correct for CNC words) with a hearing aid at the pre-operative interval and the cochlear implant at the 12-month interval for the affected ear (masking presented to the contralateral ear).||||<0.001
72408462|NCT00023673|144325499|SUPERIORITY|||||||0.22|||||||Wilcoxon (Mann-Whitney)|2-sided significance level = 0.05||Esophagitis toxicity (\<Grade 2 vs. \>= Grade 2): Lung V20||||0.22
72535557|NCT02203305|144600502|SUPERIORITY||||||<|0.001||||||A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity.|ANOVA|||Participants listened with a bone conduction device preoperatively and with the cochlear implant at 1, 3, 6, 9, and 12 months post-activation. Overall root-mean-square (RMS) error is the difference between the sound source azimuth and the response azimuth and a lower score indicates more accurate localization of the sound source. Repeated-measures ANOVA compared performance over time.||||<0.001
72535558|NCT02203305|144600502|SUPERIORITY||||||<|0.001||||||A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity.|ANOVA|||Participants listening with a bone conduction device preoperatively and with the cochlear implant at 1, 3, 6, 9, and 12 months post-activation. Overall root-mean-square (RMS) error is the difference between the sound source azimuth and the response azimuth and a lower score indicates more accurate localization of the sound source. Repeated-measures ANOVA compared performance over time.||||<0.001
72573074|NCT03118570|144673086|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.291||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 12||||0.291
72408463|NCT00023673|144325500|SUPERIORITY|||||||0.3|||||||t-test, 2 sided|2-sided significance level = 0.05||Lung toxicity (\<Grade 3 vs. \>= Grade 3): Mean Lung Dose||||0.30
72408464|NCT00023673|144325500|SUPERIORITY|||||||0.17|||||||t-test, 2 sided|2-sided significance level = 0.05||Esophagitis toxicity (\<Grade 2 vs. \>= Grade 2): Mean Lung Dose||||0.17
72408465|NCT00023673|144325500|SUPERIORITY|||||||0.08|||||||t-test, 2 sided|2-sided significance level = 0.05||Esophagitis toxicity (\<Grade 2 vs. \>= Grade 2): Mean Esophageal Dose||||0.08
72408466|NCT02660359|144325527|SUPERIORITY|If both p-values for the 2 primary tests (the test of Dysport® 800 U vs. placebo and the test of Dysport® 600 U vs. placebo) were lower than 0.05, both were declared statistically significant. If 1 of the primary tests had a p-value greater than or equal to 0.05, then the other test was declared statistically significant if its p-value was lower than 0.025 and only the significant dose continued in the hierarchal testing strategy.|LS Mean Difference|-8.97||||0.0001|TWO_SIDED|95.0|-13.5|-4.44|||MMLM|||Treatment group, visit (Week 6), treatment-by-visit interaction, recorded stratification factors (aetiology of NDO \[SCI or MS\], prior intradetrusor \[Botulinum toxin \[BTX\]-naïve or BTX-non-naïve\]) and study baseline value (weekly number of UI episodes) as fixed effect variables, and subject as a random effect.||-4.44|-13.5|0.0001
72408467|NCT02660359|144325527|SUPERIORITY|If both p-values for the 2 primary tests (the test of Dysport® 800 U vs. placebo and the test of Dysport® 600 U vs. placebo) were lower than 0.05, both were declared statistically significant. If 1 of the primary tests had a p-value greater than or equal to 0.05, then the other test was declared statistically significant if its p-value was lower than 0.025 and only the significant dose continued in the hierarchal testing strategy.|LS Mean Difference|-9.76|||<|0.0001|TWO_SIDED|95.0|-14.41|-5.12|||MMLM|||Treatment group, visit (Week 6), treatment-by-visit interaction, recorded stratification factors (aetiology of NDO \[SCI or MS\], prior intradetrusor \[Botulinum toxin \[BTX\]-naïve or BTX-non-naïve\]) and study baseline value (weekly number of UI episodes) as fixed effect variables, and subject as a random effect.||-5.12|-14.41|<0.0001
72408468|NCT02660359|144325528|SUPERIORITY|This secondary endpoint was included in the hierarchical analysis and was tested for both doses at the 0.05 level using a hierarchical methodology.|Odds Ratio (OR)|45.55||||0.0002|TWO_SIDED|95.0|6.09|340.69|||Generalised linear mixed model (GLMM)|||Treatment group, recorded stratification factors, visit, treatment-by-visit interaction, study baseline- by-visit interaction and study baseline weekly number of UI episodes as fixed effect.||340.69|6.09|0.0002
72408469|NCT02660359|144325528|SUPERIORITY|This secondary endpoint was included in the hierarchical analysis and was tested for both doses at the 0.05 level using a hierarchical methodology.|Odds Ratio (OR)|31.69||||0.0009|TWO_SIDED|95.0|4.17|240.58|||GLMM|||Treatment group, recorded stratification factors, visit, treatment-by-visit interaction, study baseline-by-visit interaction and study baseline weekly number of UI episodes as fixed effect.||240.58|4.17|0.0009
72408470|NCT02660359|144325529|SUPERIORITY|Treatment group, recorded stratification factors, visit, treatment-by-visit interaction, study baseline-by-visit interaction and study baseline weekly number of UI episodes as fixed effect.|Odds Ratio (OR)|3.55||||0.0007|TWO_SIDED|95.0|1.72|7.34||This secondary endpoint was not included within the hierarchical testing procedure and was analysed for exploratory purposes only to compare each Dysport® dose to placebo at a 0.05 type one error rate.|GLMM|||Treatment comparison at ≥30% Improvement Level: Dysport® 600 U versus Placebo.||7.34|1.72|0.0007
72408471|NCT02660359|144325529|SUPERIORITY|Treatment group, recorded stratification factors, visit, treatment-by-visit interaction, study baseline-by-visit interaction and study baseline weekly number of UI episodes as fixed effect.|Odds Ratio (OR)|2.94||||0.0037|TWO_SIDED|95.0|1.43|6.07||This secondary endpoint was not included within the hierarchical testing procedure and was analysed for exploratory purposes only to compare each Dysport® dose to placebo at a 0.05 type one error rate.|GLMM|||Treatment comparison at ≥30% Improvement Level: Dysport® 800 U versus Placebo||6.07|1.43|0.0037
72408472|NCT02660359|144325529|SUPERIORITY|Treatment group, recorded stratification factors, visit, treatment-by-visit interaction, study baseline-by-visit interaction and study baseline weekly number of UI episodes as fixed effect.|Odds Ratio (OR)|3.98|||<|0.0001|TWO_SIDED|95.0|2.03|7.79||This secondary endpoint was not included within the hierarchical testing procedure and was analysed for exploratory purposes only to compare each Dysport® dose to placebo at a 0.05 type one error rate.|GLMM|||Treatment comparison at ≥50% Improvement level: Dysport® 600 U versus Placebo||7.79|2.03|<0.0001
72408473|NCT02660359|144325529|SUPERIORITY|Treatment group, recorded stratification factors, visit, treatment-by- visit interaction, study baseline-by-visit interaction and study baseline weekly number of UI episodes as fixed effect.|Odds Ratio (OR)|2.73||||0.0034|TWO_SIDED|95.0|1.4|5.33||This secondary endpoint was not included within the hierarchical testing procedure and was analysed for exploratory purposes only to compare each Dysport® dose to placebo at a 0.05 type one error rate.|GLMM|||Treatment comparison at ≥50% Improvement level: Dysport® 800 U versus Placebo||5.33|1.40|0.0034
72408474|NCT02660359|144325529|SUPERIORITY|Treatment group, recorded stratification factors, visit, treatment-by-visit interaction, study baseline-by-visit interaction and study baseline weekly number of UI episodes as fixed effect.|Odds Ratio (OR)|7.38|||<|0.0001|TWO_SIDED|95.0|3.5|15.58||This secondary endpoint was not included within the hierarchical testing procedure and was analysed for exploratory purposes only to compare each Dysport® dose to placebo at a 0.05 type one error rate.|GLMM|||Treatment comparison at ≥75% Improvement level: Dysport® 600 U versus Placebo||15.58|3.5|<0.0001
72408475|NCT02660359|144325529|SUPERIORITY|Treatment group, recorded stratification factors, visit, treatment-by-visit interaction, study baseline-by-visit interaction and study baseline weekly number of UI episodes as fixed effect.|Odds Ratio (OR)|5.28|||<|0.0001|TWO_SIDED|95.0|2.48|11.24||This secondary endpoint was not included within the hierarchical testing procedure and was analysed for exploratory purposes only to compare each Dysport® dose to placebo at a 0.05 type one error rate.|GLMM|||Treatment comparison at ≥75% Improvement level: Dysport® 800 U versus Placebo||11.24|2.48|<0.0001
72535559|NCT02203305|144600502|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||Compare localization performance with the cochlear implant to a bone-conduction device at the 12-month interval using a paired samples t-test.||||<0.001
72535560|NCT02203305|144600502|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||Compare localization performance with the cochlear implant to a bone-conduction device at the 12-month interval using a paired samples t-test.||||<0.001
72573075|NCT03118570|144673086|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.324||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 18||||0.324
72573076|NCT03118570|144673086|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.188||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 18||||0.188
72573077|NCT03118570|144673086|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.503||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 18||||0.503
72573078|NCT03118570|144673086|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.385||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 24||||0.385
72573079|NCT03118570|144673086|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.727||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 24||||0.727
72535561|NCT02203305|144600503|SUPERIORITY||||||<|0.001||||||A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity.|ANOVA|||The Abbreviated Profile of Hearing Aid Benefit, participants rank their perceived difficulty on a scale of 1-99, with lower values indicate less perceived difficulty. The global score is calculated from the responses on the ease of communication, reverberation, and effectiveness in background noise subscales. Responses at the preoperative interval (alternative treatments for unilateral hearing loss) were compared to responses over time with the cochlear implant using a repeated-measures ANOVA.||||<0.001
72573080|NCT03118570|144673086|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.338||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 24||||0.338
72573081|NCT03118570|144673087|SUPERIORITY|Comparison is between the Visit and Baseline|||||<|0.001||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 6||||< 0.001
72573082|NCT03118570|144673087|SUPERIORITY|Comparison is between the Visit and Baseline|||||<|0.001||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 12||||< 0.001
72573083|NCT03118570|144673087|SUPERIORITY|Comparison is between the Visit and Baseline|||||<|0.001||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 6||||< 0.001
72573084|NCT03118570|144673087|SUPERIORITY|Comparison is between the Visit and Baseline|||||<|0.001||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 12||||< 0.001
72408476|NCT02660359|144325531|SUPERIORITY|This secondary endpoint was not included within the hierarchical testing procedure and was analysed for exploratory purposes only to compare each Dysport® dose to placebo at a 0.05 type one error rate.|LS Mean Difference|96.14|||<|0.0001|TWO_SIDED|95.0|53.1|139.19|||MMRM|||Treatment group, visit (Week 6), treatment-by-visit interaction, recorded stratification factors (aetiology of NDO \[SCI or MS\], prior intradetrusor \[BTX-naïve or BTX-non-naïve\]) and study baseline value (total volume per void) as fixed effect variables, and subject as a random effect.||139.19|53.10|<0.0001
72408477|NCT02660359|144325531|SUPERIORITY|This secondary endpoint was not included within the hierarchical testing procedure and was analysed for exploratory purposes only to compare each Dysport® dose to placebo at a 0.05 type one error rate.|LS Mean Difference|90.78|||<|0.0001|TWO_SIDED|95.0|47.07|134.48|||MMRM|||Treatment group, visit (Week 6), treatment-by-visit interaction, recorded stratification factors (aetiology of NDO \[SCI or MS\], prior intradetrusor \[BTX-naïve or BTX-non-naïve\]) and study baseline value (total volume per void) as fixed effect variables, and subject as a random effect.||134.48|47.07|<0.0001
72408478|NCT02660359|144325532|SUPERIORITY|This secondary endpoint was not included within the hierarchical testing procedure and was analysed for exploratory purposes only to compare each Dysport® dose to placebo at a 0.05 type one error rate.|LS Mean Difference|175.0|||<|0.0001|TWO_SIDED|95.0|122.9|227.0|||ANCOVA|||Treatment group, recorded stratification factors (aetiology of NDO \[SCI or MS\], prior intradetrusor \[BTX- naïve or BTX-non-naïve\]) and baseline value of MCC as covariates.||227.0|122.90|<0.0001
72573085|NCT03118570|144673089|SUPERIORITY|Comparison is between the Visit and Baseline|||||<|0.001||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Lumbar||||< 0.001
72573086|NCT03118570|144673089|SUPERIORITY|Comparison is between the Visit and Baseline|||||<|0.001||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Lumbar||||< 0.001
72573087|NCT03118570|144673089|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.08||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Lumbar||||0.080
72535562|NCT02203305|144600503|SUPERIORITY||||||<|0.001||||||A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity.|ANOVA|||The Abbreviated Profile of Hearing Aid Benefit, participants rank their perceived difficulty on a scale of 1-99, with lower values indicate less perceived difficulty. The global score is calculated from the responses on the ease of communication, reverberation, and effectiveness in background noise subscales. Responses at the preoperative interval (alternative treatments for unilateral hearing loss) were compared to responses over time with the cochlear implant using a repeated-measures ANOVA.||||<0.001
72535563|NCT02203305|144600503|SUPERIORITY||||||<|0.001||||||A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity.|Mixed Models Analysis|Main effects: interval (p\<0.001) and subscales (p\<0.001). Interaction: interval and subscales (p\<0.001).||The Abbreviated Profile of Hearing Aid Benefit, participants rank their perceived difficulty on a scale of 1-99, with lower values indicate less perceived difficulty. Subscales include: ease of communication, reverberation, effectiveness in background noise, and reverberation. A repeated-measures ANOVA compared the main effects of interval and subscale and their interaction from the preoperative interval (alternative treatments) and over time with the cochlear implant.||||<0.001
72535564|NCT02203305|144600503|SUPERIORITY||||||<|0.01||||||A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity.|Mixed Models Analysis|Main effects: interval (p\<0.001) and subscales (p=0.010). Interaction: interval and subscales (p=0.001).||The Abbreviated Profile of Hearing Aid Benefit, participants rank their perceived difficulty on a scale of 1-99, with lower values indicate less perceived difficulty. Subscales include: ease of communication, reverberation, effectiveness in background noise, and reverberation. A repeated-measures ANOVA compared the main effects of interval and subscale and their interaction from the preoperative interval (alternative treatments) and over time with the cochlear implant.||||<0.010
72535565|NCT02203305|144600504|SUPERIORITY||||||<|0.001||||||A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity.|ANOVA|||"The Tinnitus Handicap Inventory is a 25-item questionnaire. The subject answers yes (4 points), sometimes (2 points), or no (0 points) to each question. Responses are added to quantify tinnitus severity: none/slight (0-16), mild (18-36), moderate (38-56), severe (58-76), and catastrophic (78-100). Responses were compared at the preoperative interval (alternative treatments) and over the post-activation time period (1, 3, 6, 9, and 12 months) with the cochlear implant."||||<0.001
72573088|NCT03118570|144673089|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.238||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Total body||||0.238
72573089|NCT03118570|144673089|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.238||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Total body||||0.238
72573090|NCT03118570|144673089|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.035||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Total body||||0.035
72573091|NCT03118570|144673089|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.687||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Femoral neck||||0.687
72573092|NCT03118570|144673089|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.107||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Femoral neck||||0.107
72573093|NCT03118570|144673089|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.128||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Femoral neck||||0.128
72535566|NCT02203305|144600504|SUPERIORITY||||||=|0.003||||||A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity.|ANOVA|||"The Tinnitus Handicap Inventory is a 25-item questionnaire. The subject answers yes (4 points), sometimes (2 points), or no (0 points) to each question. Responses are added to quantify tinnitus severity: none/slight (0-16), mild (18-36), moderate (38-56), severe (58-76), and catastrophic (78-100). Responses were compared at the preoperative interval (alternative treatments) and over the post-activation time period (1, 3, 6, 9, and 12 months) with the cochlear implant."||||=0.003
72535567|NCT02203305|144600505|SUPERIORITY||||||<|0.001||||||A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity.|ANOVA|||Responses on the SSQ as measured with the total score were compared at the preoperative interval (alternative treatments for SSD) and over the post-activation period (i.e., 1, 3, 6, 9, and 12 months).||||<0.001
72535568|NCT02203305|144600505|SUPERIORITY||||||<|0.001||||||A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity.|ANOVA|||Responses on the SSQ as measured with the total score were compared at the preoperative interval (alternative treatments for asymmetric hearing loss) and over the post-activation period (i.e., 1, 3, 6, 9, and 12 months).||||<0.001
72535569|NCT02203305|144600505|SUPERIORITY||||||<|0.001||||||"There were significant main effects of interval (p\<0.001) and subscale (p\<0.001) and interaction (p=0.001).~A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity."|Mixed Models Analysis|Main effects: interval (p\<0.001) and subscale (p\<0.001). Interaction: interval and subscale (p=0.001).||Responses on the SSQ as measured with the subscales (speech, spatial, \& qualities) were compared at the preoperative interval (alternative treatments for SSD) and over the post-activation period (i.e., 1, 3, 6, 9, and 12 months). A repeated-measures ANOVA assessed the main effects of interval and subscale, and their interaction.||||<0.001
72573094|NCT03118570|144673090|SUPERIORITY|Comparison is between the Visit and Baseline|||||<|0.001||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Lumbar||||< 0.001
72573095|NCT03118570|144673090|SUPERIORITY|Comparison is between the Visit and Baseline|||||<|0.001||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Lumbar||||< 0.001
72573096|NCT03118570|144673090|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.088||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Lumbar||||0.088
72626595|NCT01576783|144781978|OTHER|Results are the comparison of proportion of those with a developmental condition between groups (DHA+AA vs. Placebo) at post-intervention follow-up (median of 8.3 months (IQR = 4.8) after trial completion and supplementation stopped).|Odds Ratio (OR)|1.63|||||TWO_SIDED|95.0|0.8|3.32||||||||3.32|0.80|
72408479|NCT02660359|144325532|SUPERIORITY|This secondary endpoint was not included within the hierarchical testing procedure and was analysed for exploratory purposes only to compare each Dysport® dose to placebo at a 0.05 type one error rate.|LS Mean Difference|168.4|||<|0.0001|TWO_SIDED|95.0|113.6|223.1|||ANCOVA|||Treatment group, recorded stratification factors (aetiology of NDO \[SCI or MS\], prior intradetrusor \[BTX- naïve or BTX-non-naïve\]) and baseline value of MCC as covariates.||223.1|113.6|<0.0001
72535570|NCT02203305|144600505|SUPERIORITY||||||<|0.034||||||A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity.|Mixed Models Analysis|Main effects: interval (p\<0.001) and subscale (p\<0.001). Interaction: interval and subscale (p=0.034).||Responses on the SSQ as measured with the subscales (speech, spatial, \& qualities) were compared at the preoperative interval (alternative treatments for asymmetric hearing loss) and over the post-activation period (i.e., 1, 3, 6, 9, and 12 months). A repeated-measures ANOVA assessed the main effects of interval and subscale, and their interaction.||||<0.034
72573097|NCT03118570|144673090|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.184||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Total body||||0.184
72573098|NCT03118570|144673090|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.144||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Total body||||0.144
72573099|NCT03118570|144673090|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.028||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Total body||||0.028
72573100|NCT03118570|144673090|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.694||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Femoral neck||||0.694
72573101|NCT03118570|144673090|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.143||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Femoral neck||||0.143
72573102|NCT03118570|144673090|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.111||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Femoral neck||||0.111
72573103|NCT03118570|144673091|SUPERIORITY|Comparison is between the Visit and Baseline|||||<|0.001||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Lumbar||||< 0.001
72626596|NCT01576783|144781979|OTHER|Results are the comparison of proportion of those with a behavioral condition between groups (DHA+AA vs. Placebo) at post-intervention follow-up (median of 8.3 months (IQR = 4.8) after trial completion and supplementation stopped).|Odds Ratio (OR)|4.5|||||TWO_SIDED|95.0|0.52|39.15||||||||39.15|0.52|
72626597|NCT05395936|144782003|SUPERIORITY|||||||0.0001|||||||t-test, 2 sided|||||||0.0001
72626598|NCT02180828|144782018|NON_INFERIORITY_OR_EQUIVALENCE|Yes||||||0.925|||||||Chi-squared|||||||0.925
72535571|NCT02203305|144600505|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|Main effects: interval (p\<0.001) and pragmatic subscale (p\<0.001). Interaction: interval and pragmatic subscale (p\<0.001).||Responses on the SSQ Speech pragmatic subscale over the study period (i.e., preoperative, and 1, 3, 6, 9, and 12 months post-activation). A repeated-measures ANOVA compared the main effects of interval and pragmatic subscale and their interaction over time.||||<0.001
72535572|NCT02203305|144600505|SUPERIORITY||||||<|0.192|||||||Mixed Models Analysis|Main effect: interval (p\<0.001) and pragmatic subscale (p=0.192). Interaction: interval and pragmatic subscale (p=0.001).||Responses on the SSQ Spatial pragmatic subscale over the study period (i.e., preoperative, and 1, 3, 6, 9, and 12 months post-activation). A repeated-measures ANOVA compared the main effects of interval and pragmatic subscale and their interaction over time.||||<0.192
72535573|NCT02203305|144600505|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|Main effects: interval (p\<0.001) and pragmatic subscale (p\<0.001). Interaction: interval and pragmatic subscale (p\<0.001).||Responses on the SSQ Qualities of Hearing pragmatic subscale over the study period (i.e., preoperative, and 1, 3, 6, 9, and 12 months post-activation). A repeated-measures ANOVA compared the main effects of interval and pragmatic subscale and their interaction over time.||||<0.001
72535574|NCT02203305|144600505|SUPERIORITY||||||<|0.479|||||||Mixed Models Analysis|Main effects: interval (p\<0.001) and pragmatic subscale (p\<0.001). Interaction: interval and pragmatic subscale (p=0.479).||Responses on the SSQ Speech pragmatic subscale over the study period (i.e., preoperative, and 1, 3, 6, 9, and 12 months post-activation). A repeated-measures ANOVA compared the main effects of interval and pragmatic subscale and their interaction over time.||||<0.479
72535575|NCT02203305|144600505|SUPERIORITY||||||<|0.804|||||||Mixed Models Analysis|Main effect: interval (p\<0.001) and pragmatic subscale (p=0.804). Interaction: interval and pragmatic subscale (p=0.090).||Responses on the SSQ Spatial pragmatic subscale over the study period (i.e., preoperative, and 1, 3, 6, 9, and 12 months post-activation). A repeated-measures ANOVA compared the main effects of interval and pragmatic subscale and their interaction over time.||||<0.804
72535576|NCT02203305|144600505|SUPERIORITY||||||<|0.005|||||||Mixed Models Analysis|Main effects: interval (p\<0.001) and pragmatic subscale (p\<0.001). Interaction: interval and pragmatic subscale (p=0.005).||Responses on the SSQ Qualities of Hearing pragmatic subscale over the study period (i.e., preoperative, and 1, 3, 6, 9, and 12 months post-activation). A repeated-measures ANOVA compared the main effects of interval and pragmatic subscale and their interaction over time.||||<0.005
72535577|NCT02203305|144600506|SUPERIORITY||||||=|0.001|||||||t-test, 2 sided|||Recorded AzBio sentences in a 10-talker masker were evaluated in 2 conditions: 1) bone-conduction device at the preoperative interval and 2) with the cochlear implant (CI) at the 12-month post-activation period. A paired samples t-test compared the performance with the two devices. Percent correct data were converted to rationalized arcsine units (RAU) prior to data analysis.||||=0.001
72535578|NCT02203305|144600506|SUPERIORITY||||||=|0.034|||||||t-test, 2 sided|||Recorded AzBio sentences in a 10-talker masker were evaluated in 2 conditions: 1) bone-conduction device at the preoperative interval and 2) with the cochlear implant (CI) at the 12-month post-activation period. A paired samples t-test compared the performance with the two devices. Percent correct data were converted to rationalized arcsine units (RAU) prior to data analysis.||||=0.034
72535579|NCT02203305|144600507|SUPERIORITY||||||=|0.001|||||||t-test, 2 sided|||Recorded AzBio sentences in a 10-talker masker were evaluated in 2 conditions: 1) bone-conduction device at the preoperative interval and 2) with the cochlear implant (CI) at the 12-month post-activation period. A paired samples t-test compared the performance with the two devices. Percent correct data were converted to rationalized arcsine units (RAU) prior to data analysis.||||=0.001
72535580|NCT02203305|144600507|SUPERIORITY||||||=|0.037|||||||t-test, 2 sided|||Recorded AzBio sentences in a 10-talker masker were evaluated in 2 conditions: 1) bone-conduction device at the preoperative interval and 2) with the cochlear implant (CI) at the 12-month post-activation period. A paired samples t-test compared the performance with the two devices. Percent correct data were converted to rationalized arcsine units (RAU) prior to data analysis.||||=0.037
72535581|NCT02203305|144600508|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||Recorded AzBio sentences in a 10-talker masker were evaluated in 2 conditions: 1) bone-conduction device at the preoperative interval and 2) with the cochlear implant (CI) at the 12-month post-activation period. A paired samples t-test compared the performance with the two devices. Percent correct data were converted to rationalized arcsine units (RAU) prior to data analysis.||||<0.001
72573104|NCT03118570|144673091|SUPERIORITY|Comparison is between the Visit and Baseline|||||<|0.001||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Lumbar||||< 0.001
72535582|NCT02203305|144600508|SUPERIORITY||||||=|0.001|||||||t-test, 2 sided|||Recorded AzBio sentences in a 10-talker masker were evaluated in 2 conditions: 1) bone-conduction device at the preoperative interval and 2) with the cochlear implant (CI) at the 12-month post-activation period. A paired samples t-test compared the performance with the two devices. Percent correct data were converted to rationalized arcsine units (RAU) prior to data analysis.||||=0.001
72573105|NCT03118570|144673091|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.026||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Lumbar||||0.026
72535583|NCT02203305|144600509|SUPERIORITY||||||=|0.004|||||||t-test, 2 sided|||Recorded BKB sentences in a 4-talker masker were evaluated in 2 conditions: 1) with a bone-conduction device (preoperative interval) and 2) with the cochlear implant (CI) at the 12-month post-activation interval. Results are reported in dB SNR, where a lower value indicates better performance. A paired samples t-test compared the performance with the two devices.||||=0.004
72573106|NCT03118570|144673091|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.007||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Total body||||0.007
72626599|NCT02180828|144782019|NON_INFERIORITY_OR_EQUIVALENCE|Yes||||||0.298|||||||Chi-squared|||||||0.298
72626600|NCT02180828|144782020|NON_INFERIORITY_OR_EQUIVALENCE|90% power and a two-sided alpha level of 0.05||||||0.147|||||||Chi-squared|||||||0.147
72626601|NCT02180828|144782021|NON_INFERIORITY_OR_EQUIVALENCE|Yes||||||0.147|||||||Chi-squared|||||||0.147
72626602|NCT02180828|144782022|SUPERIORITY_OR_OTHER|||||||0.01|||||||Chi-squared|||||||0.010
72408480|NCT02660359|144325533|SUPERIORITY|This secondary endpoint was not included within the hierarchical testing procedure and was analysed for exploratory purposes only to compare each Dysport® dose to placebo at a 0.05 type one error rate.|LS Mean Difference|-32.9|||<|0.0001|TWO_SIDED|95.0|-41.5|-24.4|||ANCOVA|||Treatment group, recorded stratification factors (aetiology of NDO \[SCI or MS\], prior intradetrusor \[BTX- naïve or BTX-non-naïve\]) and baseline value of MDP as covariates.||-24.4|-41.5|<0.0001
72535584|NCT02203305|144600509|SUPERIORITY||||||=|0.004|||||||t-test, 2 sided|||Recorded BKB sentences in a 4-talker masker were evaluated in 2 conditions: 1) bone-conduction device at the preoperative interval and 2) with the cochlear implant (CI) at the 12-month post-activation period. A paired samples t-test compared the performance with the two devices. Results are reported in dB SNR, where a lower value indicates better performance.||||=0.004
72535585|NCT02203305|144600510|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||Recorded BKB sentences in a 4-talker masker were evaluated in 2 conditions: 1) bone-conduction device at the preoperative interval and 2) with the cochlear implant (CI) at the 12-month post-activation period. A paired samples t-test compared the performance with the two devices. Results are reported in dB SNR, where a lower value indicates better performance.||||<0.001
72535586|NCT02203305|144600510|SUPERIORITY||||||=|0.727|||||||t-test, 2 sided|||Recorded BKB sentences in a 4-talker masker were evaluated in 2 conditions: 1) bone-conduction device at the preoperative interval and 2) with the cochlear implant (CI) at the 12-month post-activation period. A paired samples t-test compared the performance with the two devices. Results are reported in dB SNR, where a lower value indicates better performance.||||=0.727
72535587|NCT02203305|144600511|SUPERIORITY||||||=|0.001|||||||t-test, 2 sided|||Recorded BKB sentences in a 4-talker masker were evaluated in 2 conditions: 1) bone-conduction device at the preoperative interval and 2) with the cochlear implant (CI) at the 12-month post-activation period. A paired samples t-test compared the performance with the two devices. Results are reported in dB SNR, where a lower value indicates better performance.||||=0.001
72535588|NCT02203305|144600511|SUPERIORITY||||||=|0.09|||||||t-test, 2 sided|||Recorded BKB sentences in a 4-talker masker were evaluated in 2 conditions: 1) bone-conduction device at the preoperative interval and 2) with the cochlear implant (CI) at the 12-month post-activation period. A paired samples t-test compared the performance with the two devices. Results are reported in dB SNR, where a lower value indicates better performance.||||=0.090
72626603|NCT02180828|144782023|SUPERIORITY_OR_OTHER|||||||0.002|||||||Chi-squared|||||||0.002
72626604|NCT02180828|144782024|SUPERIORITY_OR_OTHER|||||||0.658|||||||Chi-squared|||||||0.658
72408481|NCT02660359|144325533|SUPERIORITY|This secondary endpoint was not included within the hierarchical testing procedure and was analysed for exploratory purposes only to compare each Dysport® dose to placebo at a 0.05 type one error rate.|LS Mean Difference|-32.5|||<|0.0001|TWO_SIDED|95.0|-41.5|-23.4|||ANCOVA|||Treatment group, recorded stratification factors (aetiology of NDO \[SCI or MS\], prior intradetrusor \[BTX- naïve or BTX-non-naïve\]) and baseline value of MDP as covariates.||-23.4|-41.5|<0.0001
72408482|NCT02660359|144325534|SUPERIORITY|This secondary endpoint was not included within the hierarchical testing procedure and was analysed for exploratory purposes only to compare each Dysport® dose to placebo at a 0.05 type one error rate.|LS Mean Difference|152.8|||<|0.0001|TWO_SIDED|95.0|99.2|206.5|||ANCOVA|||Treatment group, recorded stratification factors (aetiology of NDO \[SCI or MS\], prior intradetrusor \[BTX- naïve or BTX-non-naïve\]) and baseline value of Vol@1stIDC as covariates.||206.5|99.2|<0.0001
72535589|NCT02203305|144600517|SUPERIORITY||||||<|0.923|||||||Mixed Models Analysis|Main effect: electrode (p\<0.001), target stimulus (p=0.923), and interval (p=0.226). Interaction: electrode and interval (p=0.496).||A linear mixed effects model compared the main effects of target stimulus (click, tone), electrode (1-5), and interval (1, 3, 6, and 12 months) on the normalized pitch match.||||<0.923
72535590|NCT02203305|144600517|OTHER||||||>|0.164|||||||bivariate pearson correlation|||Correlation between pitch perception (normalized mean pitch match) and word recognition with the CI alone.||||>0.164
72535591|NCT02203305|144600517|OTHER|bivariate pearson correlation|||||>|0.367|||||||bivariate pearson correlation|||Correlation between pitch perception (normalized mean pitch match) and speech recognition in noise (masker from the front, masker towards the better hearing ear, and masker towards the poorer hearing ear).||||>0.367
72535592|NCT02203305|144600517|OTHER|bivariate pearson correlation|||||>|0.349|||||||bivariate pearson correlation|||Correlation between pitch perception (normalized mean pitch match) and sound source localization (RMS error).||||>0.349
72535593|NCT02203305|144600518|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||"Comparison of the unaided threshold at 125 Hz at the preoperative and initial activation intervals for the 25 participants with unaided threshold of 80 dB HL or better at the preoperative interval.~The data from the SSD and AHL group were combined to review hearing preservation with long arrays. The inclusion criteria for the implanted ear were the same for the SSD and AHL groups and all subjects received the same 31.5 mm electrode array."||||<0.001
72573107|NCT03118570|144673091|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.004||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Total body||||0.004
72573108|NCT03118570|144673091|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.085||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Total body||||0.085
72573109|NCT03118570|144673091|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.04||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Femoral neck||||0.040
72626605|NCT02180828|144782025|SUPERIORITY_OR_OTHER|||||||0.123|||||||Chi-squared|||||||0.123
72626606|NCT02180828|144782026|SUPERIORITY_OR_OTHER|||||||0.274|||||||Chi-squared|||||||0.274
72626607|NCT01276704|144782027|SUPERIORITY|||||||0.72||||||a priori threshold for statistical significance: \< 0.05|Wilcoxon (Mann-Whitney)|||83% power to detect an absolute 2.5% reduction in Ki-67 for the treatment group compared with no reduction in the control group.||||0.72
72626608|NCT01276704|144782028|SUPERIORITY|||||||0.018||||||No adjustment for multiple comparisons. Standard threshold of P\<0.05|Wilcoxon (Mann-Whitney)|||||||0.018
72626609|NCT01276704|144782029|SUPERIORITY|||||||0.036||||||No adjustment for multiple comparisons. Standard threshold of P \< 0.05|Wilcoxon (Mann-Whitney)|||||||0.036
72535594|NCT02203305|144600518|SUPERIORITY||||||=|0.47|||||||ANOVA|generalized linear mixed-effects model||"Comparison of the unaided threshold at 125 Hz from the initial activation to the 12-month post-activation interval for the 9 participants with an unaided threshold of 95 dB HL or better at the initial activation interval.~The data from the SSD and AHL group were combined to review hearing preservation with long arrays. The inclusion criteria for the implanted ear were the same for the SSD and AHL groups and all subjects received the same 31.5 mm electrode array."||||=0.47
72535595|NCT02203305|144600519|SUPERIORITY||||||=|0.739|||||||t-test, 2 sided|||A paired samples t-test compared the performance with the bone-conduction device at the preoperative and 12-month intervals.||||=0.739
72535596|NCT02203305|144600519|SUPERIORITY||||||=|0.553|||||||t-test, 2 sided|||A paired samples t-test compared the performance with the bone-conduction device at the preoperative and 12-month intervals.||||=0.553
72535597|NCT02203305|144600520|SUPERIORITY||||||<|0.345||||||Percent correct data were converted to rationalized arcsine units (RAU) prior to data analysis.|ANOVA|Main effect: interval (p=0.027) and masker condition (p\<0.001). Interaction: interval and masker condition (p=0.345).||A repeated-measures ANOVA assessed the effects of interval (preoperative and 12-months) and masker condition (front, acoustic ear, or affected ear) on performance with the bone conduction device.||||<0.345
72535598|NCT02203305|144600520|SUPERIORITY||||||<|0.577||||||Percent correct data were converted to rationalized arcsine units (RAU) prior to data analysis.|ANOVA|Main effect: masker condition (p\<0.001) and interval (p=0.577). Interaction: interval and masker condition (p=0.055).||A repeated-measures ANOVA assessed the effects of interval (preoperative and 12-months) and masker condition (front, acoustic ear, or affected ear) on performance with the bone conduction device.||||<0.577
72535599|NCT02203305|144600521|SUPERIORITY||||||>|0.023|||||||Mixed Models Analysis|Main effect: coding strategy (p=0.023). Interaction: coding strategy and electrode (p=0.044). All other main effects and interactions were p\>0.160.||A linear mixed effect model assessed the main effects of stimulus, electrode, and coding strategy, and their interactions.||||>0.023
72535600|NCT02203305|144600521|SUPERIORITY||||||>|0.035|||||||t-test, 2 sided|Pitch perception for electrode 1 (p=0.035). All other comparisons were p\>0.318.||Paired samples t-tests evaluated whether pitch perception (mean normalized pitch) differed between coding strategy for each electrode.||||>0.035
72535601|NCT02203305|144600522|SUPERIORITY||||||>|0.084|||||||ANOVA|Main effects: condition (p=0.960) and interval (p=0.084). Interaction: condition and interval (p=0.433).||A repeated-measures ANOVA assessed the effects of condition (unaided, bone-conduction device) and interval (preoperative, 12-month) and their interaction on sound source localization.||||>0.084
72535602|NCT02203305|144600522|SUPERIORITY||||||>|0.434|||||||ANOVA|Main effect: condition (p=0.434) or interval (p=0.687). Interaction: condition and interval (p=0.678).||A repeated-measures ANOVA assessed the effects of condition (unaided, bone-conduction device) and interval (preoperative, 12-month) and their interaction on sound source localization.||||>0.434
72573110|NCT03118570|144673091|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.061||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Femoral neck||||0.061
72573111|NCT03118570|144673091|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.189||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Femoral neck||||0.189
72535603|NCT02203305|144600523|SUPERIORITY||||||<|0.935||||||Percent correct converted to rationalized arcsine units (RAU) prior to analysis.|ANOVA|Main effects: condition (p=0.018), interval (p=0.012), and masker (p\<0.001). Interactions: interval and masker (p\<0.001). Other interactions: p\>0.117.||A repeated-measures ANOVA assessed the effects of condition (unaided, bone-conduction device), interval (preoperative, 12-month), and masker condition and their 2-way and 3-way interactions on speech recognition in noise.||||<0.935
72573112|NCT03118570|144673092|SUPERIORITY|Comparison is between the Visit and Baseline|||||<|0.001||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Lumbar||||< 0.001
72573113|NCT03118570|144673092|SUPERIORITY|Comparison is between the Visit and Baseline|||||<|0.001||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Lumbar||||< 0.001
72573114|NCT03118570|144673092|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.035||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Lumbar||||0.035
72573115|NCT03118570|144673092|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.003||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Total body||||0.003
72535604|NCT02203305|144600523|SUPERIORITY||||||<|0.977||||||A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity.|ANOVA|Effects: interval (p=0.012) and masker (p\<0.001). Interactions: interval\&masker (p=0.020) \& condition, interval, \&masker (p=0.035). Others: (p\>0.131).||A repeated-measures ANOVA assessed the effects of condition (unaided, bone-conduction device), interval (preoperative, 12-month), and masker condition and their 2-way and 3-way interactions on speech recognition in noise.||||<0.977
72535605|NCT03586427|144600524|OTHER|Mixed model of repeated measures least square estimates of change compared to placebo|||||>|0.05||||||Comparison of each dose level change from baseline to placebo baseline yielded P values \>0.05|Mixed Models Analysis|||Each dose group was compared to placebo||||>0.05
72535606|NCT00423137|144600537|OTHER||Difference of least square means|-1.385|STANDARD_ERROR_OF_MEAN|2.181||0.5305|||||||ANCOVA|The adjusted least squares mean is estimated based on the ANCOVA model with treatment, centre, and baseline.||||||0.5305
72573116|NCT03118570|144673092|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.003||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Total body||||0.003
72535607|NCT00423137|144600538|OTHER||Difference of least square means|-0.049|STANDARD_ERROR_OF_MEAN|0.033||0.1498|||||||ANCOVA|The adjusted least squares mean is estimated based on the ANCOVA model with treatment, centre, and baseline.|Difference to Placebo \[Treatment-Placebo\]|||||0.1498
72535608|NCT00423137|144600541|OTHER||Difference of least square means|0.335|STANDARD_ERROR_OF_MEAN|0.434||0.4472|||||||ANCOVA|The adjusted least squares mean is estimated based on the ANCOVA model with treatment, centre, and baseline.|Difference to Placebo \[Treatment-Placebo\]|||||0.4472
72535609|NCT00423137|144600542|OTHER||Difference of least square means|-0.141|STANDARD_ERROR_OF_MEAN|0.342||0.6829|||||||ANCOVA|The adjusted least squares mean is estimated based on the ANCOVA model with treatment, centre, and baseline.|Difference to Placebo \[Treatment-Placebo\]|||||0.6829
72535610|NCT00423137|144600543|OTHER||Difference of least square means|0.571|STANDARD_ERROR_OF_MEAN|0.391||0.1565|||||||ANCOVA|The adjusted least squares mean is estimated based on the ANCOVA model with treatment, centre, and baseline.|Difference to Placebo \[Treatment-Placebo\]|||||0.1565
72535611|NCT00423137|144600544|OTHER||Difference of least square means|1.081|STANDARD_ERROR_OF_MEAN|1.185||0.3709|||||||ANCOVA|The adjusted least squares mean is estimated based on the ANCOVA model with treatment, centre, and baseline.|Difference to Placebo \[Treatment-Placebo\]|||||0.3709
72535612|NCT00423137|144600545|OTHER||Difference of least square means|-52.083|STANDARD_ERROR_OF_MEAN|16.48||0.0044|||||||ANCOVA|The adjusted least squares mean is estimated based on the one way ANOVA model with Treatment.|Difference to Placebo \[Treatment-Placebo\]|||||0.0044
72535613|NCT00423137|144600546|OTHER||Difference of least square means|-67.012|STANDARD_ERROR_OF_MEAN|21.29||0.0056|||||||ANCOVA|The adjusted least squares mean is estimated based on the one way ANOVA model with Treatment.|Difference to Placebo \[Treatment-Placebo\]|||||0.0056
72535614|NCT00423137|144600547|OTHER||Difference of least square means|-62.571|STANDARD_ERROR_OF_MEAN|18.42||0.0025|||||||ANCOVA|The adjusted least squares mean is estimated based on the one way ANOVA model with Treatment.|Difference to Placebo \[Treatment-Placebo\]|||||0.0025
72535615|NCT00423137|144600548|OTHER||Difference of least square means|-40.067|STANDARD_ERROR_OF_MEAN|18.8||0.0439|||||||ANCOVA|The adjusted least squares mean is estimated based on the one way ANOVA model with Treatment.|Difference to Placebo \[Treatment-Placebo\]|||||0.0439
72535616|NCT00423137|144600549|OTHER||Difference of least square means|-57.46|STANDARD_ERROR_OF_MEAN|21.3||0.0129|||||||ANCOVA|The adjusted least squares mean is estimated based on the one way ANOVA model with Treatment.|Difference to Placebo \[Treatment-Placebo\]|||||0.0129
72535617|NCT00423137|144600550|OTHER||Difference of least square means|-55.332|STANDARD_ERROR_OF_MEAN|17.11||0.0037|||||||ANCOVA|The adjusted least squares mean is estimated based on the one way ANOVA model with Treatment.|Difference to Placebo \[Treatment-Placebo\]|||||0.0037
72535618|NCT00423137|144600551|OTHER||Difference of least square means|0.0|STANDARD_ERROR_OF_MEAN|0.001||0.9076|||||||ANCOVA|The adjusted least squares mean is estimated based on the ANCOVA model with treatment, centre, and baseline.|Difference to Placebo \[Treatment-Placebo\]|||||0.9076
72535619|NCT00423137|144600552|OTHER||Difference of least square means|-13453.0|STANDARD_ERROR_OF_MEAN|16118.0||0.4121|||||||ANCOVA|The adjusted least squares mean is estimated based on the ANCOVA model with treatment, centre, and baseline.|Difference to Placebo \[Treatment-Placebo\]|||||0.4121
72535620|NCT00423137|144600553|OTHER||Difference of least square means|-78.619|STANDARD_ERROR_OF_MEAN|298.91||0.7948|||||||ANCOVA|The adjusted least squares mean is estimated based on the ANCOVA model with treatment, centre, and baseline.|Difference to Placebo \[Treatment-Placebo\]|||||0.7948
72535621|NCT00423137|144600554|OTHER||Difference of least square means|0.195|STANDARD_ERROR_OF_MEAN|0.101||0.064|||||||ANCOVA|The adjusted least squares mean is estimated based on the ANCOVA model with treatment, centre, and baseline.|Difference to Placebo \[Treatment-Placebo\]|||||0.0640
72535622|NCT00423137|144600555|OTHER||Difference of least square means|0.007|STANDARD_ERROR_OF_MEAN|0.004||0.0587|||||||ANCOVA|The adjusted least squares mean is estimated based on the ANCOVA model with treatment, centre, and baseline.|Difference to Placebo \[Treatment-Placebo\]|||||0.0587
72535623|NCT00593385|144600573|OTHER||Meta-Analysis|9.67||||0.005|ONE_SIDED|95.0||16.57||An exact one sided upper 95% confidence interval of the primary endpoint rate was calculated based on primary analysis population.|Exact test of the binomial distribution||To estimate primary endpoint rate, a meta-analysis was performed on data from 3 previous studies. The meta-analytical rate derived was 9.67%|The composite event rate to determine the performance metric of 16.57% was based on a meta-analysis performed on data from 3 previous studies(9.67%). A 6.9% margin was deemed acceptable at the time of study design. Rejection of the null hypothesis requires that the iCAST Covered Stent primary endpoint rate was significantly below 16.57%. Other assumptions for the analysis included a power of 80% and one-sided alpha error of 5%.||16.57||0.005
72535624|NCT01797458|144600608|SUPERIORITY_OR_OTHER_LEGACY|||||||0.02||||||Twenty-five teeth experienced at least one 'Minor' failure (reversible pulpitis, caries progression, and secondary caries): NRCT 9 (6.4%), CR 14 (10%), HT 2 (1.4%).|Kruskal-Wallis|||The null hypothesis was no difference at 2 yrs among any of the 3 arms for the primary outcome of success or minor failure.||||0.02
72535625|NCT00924313|144600623|SUPERIORITY||||||<|0.0001||||||The reported p-value is representative of the difference in levels of the histopathologic confirmed tumor and normal prostate tissue.|Spearman rank correlation|||||||<0.0001
72535626|NCT00924313|144600623|SUPERIORITY|||||||0.65||||||The reported p-value is representative of the BPH high uptake level.|Spearman rank correlation|||||||0.65
72535627|NCT00924313|144600626|SUPERIORITY|||||||0.55|||||||Spearman rank correlation|||||||0.55
72535628|NCT00924313|144600628|SUPERIORITY|||||||0.407|||||||Spearman rank correlation|||||||0.407
72535629|NCT00972309|144600742|OTHER|||||||0.003|||||||Wilcoxon (Mann-Whitney)|||||||0.003
72535630|NCT00948896|144600744|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Negative Binomial Regression|||Null Hypothesis: Within HIV-unexposed participants, there is no difference in the incidence of all grade 3-4 adverse events per PYAR between the control arm and the monthly DP arm.||||<0.0001
72535631|NCT00948896|144600744|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED|||||Monthly DP arm compared to No chemoprevention arm|Negative Binomial Regression|||Null Hypothesis: Within HIV-unexposed participants, there is no difference in the incidence of elevated temperature adverse events per PYAR between the control arm and the monthly DP arm.||||<0.01
72573117|NCT03118570|144673092|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.088||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Total body||||0.088
72573118|NCT03118570|144673092|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.016||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Femoral neck||||0.016
72573119|NCT03118570|144673092|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.068||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Femoral neck||||0.068
72573120|NCT03118570|144673092|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.16||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Femoral neck||||0.160
72626610|NCT03801525|144782035|SUPERIORITY||Hazard Ratio (HR)|0.778||||0.696|TWO_SIDED|95.0|0.219|2.755|||Log Rank|||||2.755|0.219|0.6960
72626611|NCT03801525|144782042|SUPERIORITY||Hazard Ratio (HR)|0.201||||0.1038|TWO_SIDED|95.0|0.023|1.721|||Log Rank|||||1.721|0.023|0.1038
72535632|NCT00948896|144600744|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED|||||Monthly DP arm compared to No chemoprevention arm|Negative Binomial Regression|||Null Hypothesis: Within HIV-unexposed participants, there is no difference in the incidence of anemia adverse events per PYAR between the control arm and the monthly DP arm.||||<0.01
72535633|NCT00948896|144600744|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|||||Monthly DP arm compared to No chemoprevention arm|Negative Binomial Regression|||Null Hypothesis: Within HIV-unexposed participants, there is no difference in the incidence of thrombocytopenia adverse events per PYAR between the control arm and the monthly DP arm.||||<0.05
72535634|NCT00948896|144600744|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|||||Monthly DP arm compared with no chemoprevention arm.|Negative Binomial Regression|||Null Hypothesis: Within HIV-exposed participants, there is no difference in the incidence of all grade 3-4 adverse events per PYAR between the control arm and the monthly DP arm.||||<0.05
72535635|NCT00948896|144600744|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|||||Monthly DP arm compared with no chemoprevention arm.|Negative Binomial Regression|||Null Hypothesis: Within HIV-exposed participants, there is no difference in the incidence of anemia adverse events per PYAR between the control arm and the monthly DP arm||||<0.05
72535636|NCT00948896|144600744|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|||||Monthly DP arm compared with the no chemoprevention arm.|Negative Binomial Regression|||Null Hypothesis: Within HIV-exposed participants, there is no difference in the incidence of elevated temperature adverse events per PYAR between the control arm and the monthly DP arm||||<0.05
72535637|NCT00948896|144600744|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED|||||Daily TS arm compare with the no chemoprevention arm.|Negative Binomial Regression|||Null Hypothesis: Within HIV-exposed participants, there is no difference in the incidence of anemia adverse events per PYAR between the control arm and the daily TS arm||||<0.01
72535638|NCT00948896|144600746|SUPERIORITY_OR_OTHER||Protective Efficacy (%)|7.0||||0.57|TWO_SIDED|95.0|-19.0|28.0|||Negative Binomial Regression||The no chemoprevention arm is the reference group.|The sample size was calculated to detect at least a 32% lower incidence of malaria in the DP arm compared to that in the TS arm. We assumed that the incidence of malaria would be 1.85 episodes per person-year with TS chemoprevention based on a prior cohort study in the same area, and thus we calculated that we would need to enroll 100 participants in each arm to detect our targeted protective efficacy with 80% power at 95% significance (two-sided), allowing for 10% loss to follow-up.||28|-19|0.57
72535639|NCT00948896|144600746|SUPERIORITY_OR_OTHER||Protective Efficacy (%)|28.0||||0.01|TWO_SIDED|95.0|7.0|44.0|||Negative Binomial Regression||The no chemoprevention arm is the reference arm.|The sample size was calculated to detect at least a 32% lower incidence of malaria in the DP arm compared to that in the TS arm. We assumed that the incidence of malaria would be 1.85 episodes per person-year with TS chemoprevention based on a prior cohort study in the same area, and thus we calculated that we would need to enroll 100 participants in each arm to detect our targeted protective efficacy with 80% power at 95% significance (two-sided), allowing for 10% loss to follow-up.||44|7|0.01
72535640|NCT00948896|144600746|SUPERIORITY_OR_OTHER||Protective Efficacy (%)|58.0|||<|0.001|TWO_SIDED|95.0|45.0|67.0|||Negative Binomial Regression||The no chemoprevention arm is the reference arm.|The sample size was calculated to detect at least a 32% lower incidence of malaria in the DP arm compared to that in the TS arm. We assumed that the incidence of malaria would be 1.85 episodes per person-year with TS chemoprevention based on a prior cohort study in the same area, and thus we calculated that we would need to enroll 100 participants in each arm to detect our targeted protective efficacy with 80% power at 95% significance (two-sided), allowing for 10% loss to follow-up.||67|45|<0.001
72535641|NCT00948896|144600747|SUPERIORITY_OR_OTHER||Protective Efficacy (%)|9.0||||0.065|TWO_SIDED|95.0|-35.0|38.0|||Negative Binomial Regression||The no chemoprevention arm is the reference arm.|We assumed that the incidence of malaria would be 1.85 episodes per person year with TS based on a prior cohort study in the same area, and thus, that we would need to enroll 50 participants in each arm to detect a reduction in the incidence of malaria in either the monthly SP or DP arms (two-sided significance level 0.05) compared with the daily TS arm of 48% or greater with 80% power at 95% significance (two-sided), allowing for 10% loss to follow-up.||38|-35|0.065
72573121|NCT03118570|144673093|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.065||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 6||||0.065
72573122|NCT03118570|144673093|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.405||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 6||||0.405
72573123|NCT03118570|144673093|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.966||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 6||||0.966
72573124|NCT03118570|144673093|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.003||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 12||||0.003
72573125|NCT03118570|144673093|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.229||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 12||||0.229
72573126|NCT03118570|144673093|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.807||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 12||||0.807
72573127|NCT03118570|144673093|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.042||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 18||||0.042
72573128|NCT03118570|144673093|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.283||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 18||||0.283
72535642|NCT00948896|144600747|SUPERIORITY_OR_OTHER||Protective Efficacy (%)|49.0||||0.001|TWO_SIDED|95.0|23.0|66.0||Adjusted for age at randomization and incidence of malaria prior to randomization.|Negative Binomial Regression||Adjusted for age at randomization and incidence of malaria prior to randomization. The no chemoprevention arm is the reference arm.|We assumed that the incidence of malaria would be 1.85 episodes per person year with TS based on a prior cohort study in the same area, and thus, that we would need to enroll 50 participants in each arm to detect a reduction in the incidence of malaria in either the monthly SP or DP arms (two-sided significance level 0.05) compared with the daily TS arm of 48% or greater with 80% power at 95% significance (two-sided), allowing for 10% loss to follow-up.||66|23|0.001
72573129|NCT03118570|144673093|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.536||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 18||||0.536
72573130|NCT03118570|144673093|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.765||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 24||||0.765
72573131|NCT03118570|144673093|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.247||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 24||||0.247
72535643|NCT00948896|144600747|SUPERIORITY_OR_OTHER||Protective Efficacy (%)|69.0|||<|0.001|TWO_SIDED|95.0|53.0|80.0||Adjusted for age at randomization and incidence of malaria prior to randomization.|Negative Binomial Regression||Adjusted for age at randomization and incidence of malaria prior to randomization. The no chemoprevention arm is the reference arm.|We assumed that the incidence of malaria would be 1.85 episodes per person year with TS based on a prior cohort study in the same area, and thus, that we would need to enroll 50 participants in each arm to detect a reduction in the incidence of malaria in either the monthly SP or DP arms (two-sided significance level 0.05) compared with the daily TS arm of 48% or greater with 80% power at 95% significance (two-sided), allowing for 10% loss to follow-up.||80|53|<0.001
72573132|NCT03118570|144673093|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.05||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 24||||0.050
72573133|NCT03118570|144673093|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.037||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 6||||0.037
72573134|NCT03118570|144673093|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.174||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 6||||0.174
72573135|NCT03118570|144673093|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.558||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 6||||0.558
72408483|NCT02660359|144325534|SUPERIORITY|This secondary endpoint was not included within the hierarchical testing procedure and was analysed for exploratory purposes only to compare each Dysport® dose to placebo at a 0.05 type one error rate.|LS Mean Difference|169.7|||<|0.0001|TWO_SIDED|95.0|111.7|227.6|||ANCOVA|||Treatment group, recorded stratification factors (aetiology of NDO \[SCI or MS\], prior intradetrusor \[BTX- naïve or BTX-non-naïve\]) and baseline value of Vol@1stIDC as covariates.||227.6|111.7|<0.0001
72535644|NCT05436067|144600830|OTHER||||||<|0.001||||||Difference in head angle pitch - left between the arms|paired t-test|||This statistical analysis tests the difference between the different arms (with and without app) using a paired t-test||||<0.001
72535645|NCT05436067|144600830|OTHER||||||<|0.001||||||Difference in head angle pitch - right between the arms|paired t-test|||This statistical analysis tests the difference between the different arms (with and without app) using a paired t-test||||<0.001
72535646|NCT05436067|144600830|OTHER|||||||0.042||||||Difference in head angle yaw - extension between the arms|paired t-test|||This statistical analysis tests the difference between the different arms (with and without app) using a paired t-test||||0.042
72535647|NCT05436067|144600830|OTHER|||||||0.111||||||Difference in head angle yaw - flexion between the arms|paired t-test|||This statistical analysis tests the difference between the different arms (with and without app) using a paired t-test||||0.111
72535648|NCT05436067|144600831|OTHER|||||||0.023||||||Difference in pitch range of motion between the arms|paired t-test|||This statistical analysis tests the difference between the different arms (with and without app) using a paired t-test||||0.023
72535649|NCT05436067|144600831|OTHER||||||<|0.001|||||||paired t-test|||This statistical analysis tests the difference between the different arms (with and without app) using a paired t-test||||<0.001
72535650|NCT05436067|144600832|OTHER|||||||0.057||||||Difference in pitch velocity between the arms|paired t-test|||This statistical analysis tests the difference between the different arms (with and without app) using a paired t-test||||0.057
72535651|NCT05436067|144600832|OTHER|||||||0.003||||||Difference in yaw velocity between the arms|paired t-test|||This statistical analysis tests the difference between the different arms (with and without app) using a paired t-test||||0.003
72535652|NCT05436067|144600833|OTHER|||||||0.035||||||Weight shift exercise - mediolateral range of motion|paired t-test|||||||0.035
72535653|NCT05436067|144600833|OTHER|||||||0.006||||||Weight shift balance exercise anteroposterior range of motion|paired t-test|||||||0.006
72535654|NCT05436067|144600833|OTHER|||||||0.024||||||Single leg balance range of motion|paired t-test|||||||0.024
72535655|NCT05436067|144600833|OTHER|||||||0.257||||||Single leg balance fluency|Shapiro Wilcoxon test|Data was not normally distributed.||||||0.257
72535656|NCT05689554|144600841|SUPERIORITY||Hazard Ratio (HR)|1.11||||0.11|TWO_SIDED|95.0|0.944|1.306|||Log Rank|||||1.306|.944|0.11
72535657|NCT05689554|144600842|SUPERIORITY||Risk Ratio (RR)|1.24||||0.183|TWO_SIDED|95.0|0.9|1.7|||Regression, modified Poisson|||||1.7|.9|0.183
72535658|NCT00563706|144600848|SUPERIORITY_OR_OTHER||Least Squares (LS) Mean Difference|-12.3||||0.043|TWO_SIDED|95.0|-24.24|-0.37|||Mixed Models Analysis|||Mixed effects model was used to assess the treatment effects with change in PANSS total score from baseline as response variable, treatment, visit, and treatment by visit as fixed factors and baseline value as a covariate.||-0.37|-24.24|0.043
72535659|NCT00563706|144600848|SUPERIORITY_OR_OTHER||LS Mean Difference|-6.77||||0.457|TWO_SIDED|95.0|-24.7|11.16|||Mixed Models Analysis|||Mixed effects model was used to assess the treatment effects with change in PANSS total score from baseline as response variable, treatment, visit, and treatment by visit as fixed factors and baseline value as a covariate.||11.16|-24.70|0.457
72535660|NCT00563706|144600848|SUPERIORITY_OR_OTHER||LS Mean Difference|-11.61||||0.067|TWO_SIDED|95.0|-24.03|0.81|||Mixed Models Analysis|||Mixed effects model was used to assess the treatment effects with change in PANSS total score from baseline as response variable, treatment, visit, and treatment by visit as fixed factors and baseline value as a covariate.||0.81|-24.03|0.067
72535661|NCT00563706|144600848|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.61||||0.567|TWO_SIDED|95.0|-16.02|8.8|||Mixed Models Analysis|||Mixed effects model was used to assess the treatment effects with change in PANSS total score from baseline as response variable, treatment, visit, and treatment by visit as fixed factors and baseline value as a covariate.||8.80|-16.02|0.567
72535662|NCT00563706|144600848|SUPERIORITY_OR_OTHER||LS Mean Difference|-10.9||||0.07|TWO_SIDED|95.0|-22.71|0.92|||Mixed Models Analysis|||Mixed effects model was used to assess the treatment effects with change in PANSS total score from baseline as response variable, treatment, visit, and treatment by visit as fixed factors and baseline value as a covariate.||0.92|-22.71|0.070
72535663|NCT00563706|144600848|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.18||||0.647|TWO_SIDED|95.0|-16.87|10.5|||Mixed Models Analysis|||Mixed effects model was used to assess the treatment effects with change in PANSS total score from baseline as response variable, treatment, visit, and treatment by visit as fixed factors and baseline value as a covariate.||10.50|-16.87|0.647
72535664|NCT00563706|144600848|SUPERIORITY_OR_OTHER||LS Mean Difference|-9.73||||0.075|TWO_SIDED|95.0|-20.46|1.0|||Mixed Models Analysis|||Mixed effects model was used to assess the treatment effects with change in PANSS total score from baseline as response variable, treatment, visit, and treatment by visit as fixed factors and baseline value as a covariate.||1.00|-20.46|0.075
72535665|NCT00563706|144600848|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.44||||0.765|TWO_SIDED|95.0|-10.92|8.04|||Mixed Models Analysis|||Mixed effects model was used to assess the treatment effects with change in PANSS total score from baseline as response variable, treatment, visit, and treatment by visit as fixed factors and baseline value as a covariate.||8.04|-10.92|0.765
72535666|NCT03965754|144600859|SUPERIORITY||Odds Ratio (OR)|5.96|||<|0.001|TWO_SIDED|95.0|4.0|9.18||We used an a priori threshold of p \< .05.|Regression, Logistic|||We conducted a logistic regression with the three email conditions as dummy variables with no email as the reference group (among employees who previously enrolled in the program).||9.18|4.00|<.001
72535667|NCT03965754|144600859|SUPERIORITY||Odds Ratio (OR)|5.02|||<|0.001|TWO_SIDED|95.0|3.36|7.76||We used an a priori threshold of p \< .05.|Regression, Logistic|||We conducted a logistic regression with the three email conditions as dummy variables with no email as the reference group (among employees who previously enrolled in the program).||7.76|3.36|<.001
72408484|NCT02660359|144325535|SUPERIORITY|This secondary endpoint was not included within the hierarchical testing procedure and was analysed for exploratory purposes only to compare each Dysport® dose to placebo at a 0.05 type one error rate.|Odds Ratio (OR)|31.1|||<|0.0001|TWO_SIDED|95.0|7.05|137.09|||GLMM|||Treatment group, recorded stratification factors, visit, treatment-by-visit interaction, study baseline-by-visit interaction and study baseline weekly number of UI episodes as fixed effect.||137.09|7.05|<0.0001
72408485|NCT02660359|144325535|SUPERIORITY|This secondary endpoint was not included within the hierarchical testing procedure and was analysed for exploratory purposes only to compare each Dysport® dose to placebo at a 0.05 type one error rate.|Odds Ratio (OR)|28.08|||<|0.0001|TWO_SIDED|95.0|6.24|126.25|||GLMM|||Treatment group, recorded stratification factors, visit, treatment-by-visit interaction, study baseline-by- visit interaction and study baseline weekly number of UI episodes as fixed effect.||126.25|6.24|<0.0001
72408486|NCT04622254|144325552|SUPERIORITY||||||<|0.0001|||||||Mantel Haenszel|||||||<0.0001
72408487|NCT04622254|144325553|SUPERIORITY||||||<|0.0001|||||||Mantel Haenszel|||||||<0.0001
72408488|NCT04622254|144325554|SUPERIORITY||||||<|0.0001|||||||Mantel Haenszel|||||||<0.0001
72535668|NCT03965754|144600859|SUPERIORITY||Odds Ratio (OR)|3.3|||<|0.001|TWO_SIDED|95.0|2.17|5.17||We used an a priori threshold of p \< .05.|Regression, Logistic|||We conducted a logistic regression with the three email conditions as dummy variables with no email as the reference group (among employees who previously enrolled in the program).||5.17|2.17|<.001
72535669|NCT03965754|144600859|SUPERIORITY||Odds Ratio (OR)|3.28||||0.038|TWO_SIDED|95.0|1.16|11.71||We used an a priori threshold of p \< .05.|Regression, Logistic|||We conducted a logistic regression with the three email conditions as dummy variables with no email as the reference group (among employees who never enrolled in the program).||11.71|1.16|.038
72535670|NCT03965754|144600859|SUPERIORITY||Odds Ratio (OR)|2.01||||0.256|TWO_SIDED|95.0|0.63|7.54||We used an a priori threshold of p \< .05.|Regression, Logistic|||We conducted a logistic regression with the three email conditions as dummy variables with no email as the reference group (among employees who never enrolled in the program).||7.54|0.63|.256
72535671|NCT03965754|144600859|SUPERIORITY||Odds Ratio (OR)|1.5||||0.531|TWO_SIDED|95.0|0.43|5.89||We used an a priori threshold of p \< .05.|Regression, Logistic|||We conducted a logistic regression with the three email conditions as dummy variables with no email as the reference group (among employees who never enrolled in the program).||5.89|0.43|.531
72535672|NCT03965754|144600859|SUPERIORITY||Odds Ratio (OR)|1.19||||0.202|TWO_SIDED|95.0|0.91|1.54||We used an a priori threshold of p \< .05.|Regression, Logistic|||We conducted a logistic regression with the two experimental conditions as dummy variables with the standard email as the reference group (among employees who previously enrolled in the program).||1.54|0.91|.202
72535673|NCT03965754|144600859|SUPERIORITY||Odds Ratio (OR)|0.66||||0.005|TWO_SIDED|95.0|0.49|0.88||We used an a priori threshold of p \< .05.|Regression, Logistic|||We conducted a logistic regression with the two experimental conditions as dummy variables with the standard email as the reference group (among employees who previously enrolled in the program).||0.88|0.49|.005
72535674|NCT03965754|144600859|SUPERIORITY||Odds Ratio (OR)|0.75||||0.276|TWO_SIDED|95.0|0.69|4.16||We used an a priori threshold of p \< .05.|Regression, Logistic|||We conducted a logistic regression with the two experimental conditions as dummy variables with the standard email as the reference group (among employees who never enrolled in the program).||4.16|0.69|.276
72573136|NCT03118570|144673093|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.02||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 12||||0.020
72535675|NCT03965754|144600859|SUPERIORITY||Odds Ratio (OR)|0.75||||0.592|TWO_SIDED|95.0|0.25|2.16||We used an a priori threshold of p \< .05.|Regression, Logistic|||We conducted a logistic regression with the two experimental conditions as dummy variables with the standard email as the reference group (among employees who never enrolled in the program).||2.16|0.25|.592
72535676|NCT03965754|144600860|SUPERIORITY|We conducted a logistic regression with the two experimental conditions as dummy variables with the standard email as the reference group (among employees who previously enrolled).|Odds Ratio (OR)|1.31||||0.02|TWO_SIDED|95.0|1.04|1.65||We used an a priori threshold of p \< .05.|Regression, Logistic|||||1.65|1.04|.020
72535677|NCT03965754|144600860|SUPERIORITY||Odds Ratio (OR)|0.58|||<|0.001|TWO_SIDED|95.0|0.44|0.75||We used an a priori threshold of p \< .05.|Regression, Logistic|||We conducted a logistic regression with the two experimental conditions as dummy variables with the standard email as the reference group (among employees who previously enrolled).||0.75|0.44|<.001
72535678|NCT03965754|144600860|SUPERIORITY||Odds Ratio (OR)|0.75||||0.359|TWO_SIDED|95.0|0.41|1.38||We used an a priori threshold of p \< .05.|Regression, Logistic|||We conducted a logistic regression with the two experimental conditions as dummy variables with the standard email as the reference group (among employees who never enrolled).||1.38|0.41|.359
72573137|NCT03118570|144673093|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.346||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 12||||0.346
72408489|NCT04622254|144325555|SUPERIORITY||||||<|0.0001|||||||Mantel Haenszel|||||||<0.0001
72408490|NCT04622254|144325556|SUPERIORITY||||||<|0.0001|||||||Mantel Haenszel|||||||<0.0001
72408491|NCT04622254|144325557|SUPERIORITY||||||<|0.0001|||||||Mantel Haenszel|||||||<0.0001
72408492|NCT04622254|144325558|SUPERIORITY||||||<|0.0001|||||||Mantel Haenszel|||||||<0.0001
72408493|NCT04622254|144325559|SUPERIORITY||||||<|0.0001|||||||Mantel Haenszel|||||||<0.0001
72408494|NCT04622254|144325560|SUPERIORITY||||||<|0.0001|||||||Mantel Haenszel|||||||<0.0001
72408495|NCT04622254|144325561|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
72408496|NCT04622254|144325562|SUPERIORITY||||||<|0.0001|||||||Mantel Haenszel|||||||<0.0001
72408497|NCT04622254|144325563|SUPERIORITY||||||<|0.0001|||||||Mantel Haenszel|||||||<0.0001
72408498|NCT04622254|144325564|SUPERIORITY||||||<|0.0001|||||||Mantel Haenszel|||||||<0.0001
72408499|NCT04622254|144325564|SUPERIORITY||||||<|0.0001|||||||Mantel Haenszel|||||||<0.0001
72408500|NCT04622254|144325565|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
72408501|NCT04622254|144325565|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
72408502|NCT02652624|144325568|NON_INFERIORITY|A sample size of 470 participants (\~235 participants per treatment group) would provide at least 87% power to detect a non-inferiority margin of 4% difference in the percentage of participants with HIV-1 RNA ≥ 50 copies/mL at Week 48 between the 2 treatment groups. This was based on the assumptions that both treatment groups have 2% of participants with HIV-1 RNA ≥ 50 copies/mL (based on Gilead Genvoya and Stribild studies) and that the significance level of the test is at a 1-sided 0.025 level.|Difference in percentages|0.0|||||TWO_SIDED|95.001|-2.9|2.9|||||The difference in percentages between treatment groups and their 95.001% confidence intervals (CI) were calculated based on an unconditional exact method using 2 inverted 1-sided tests.|The null hypothesis was that the percentage of participants with HIV-1 RNA ≥ 50 copies/mL at Week 48 in the B/F/TAF group was at least 4% higher than the rate in the SBR group; the alternative hypothesis was that the percentage of participants with HIV-1 RNA ≥ 50 copies/mL in the B/F/TAF group was less than 4% higher than that in the SBR group.||2.9|-2.9|
72408503|NCT02652624|144325568|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.00
72408504|NCT02652624|144325569|NON_INFERIORITY|The non-inferiority of B/F/TAF would be established if the lower bound of the 2-sided 95.001% CI of the difference between the treatment groups (B/F/TAF group - SBR group) in the percentage of participants with HIV-1 RNA \< 50 copies/mL is greater than -10%.|Difference in percentages|0.4|||||TWO_SIDED|95.001|-3.7|4.5|||||The difference in percentages between treatment groups and their 95.001% CIs were calculated based on an unconditional exact method using 2 inverted 1-sided tests.|||4.5|-3.7|
72408505|NCT02652624|144325569|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.00
72535679|NCT03965754|144600860|SUPERIORITY|We conducted a logistic regression with the two experimental conditions as dummy variables with the standard email as the reference group (among employees who never enrolled).|Odds Ratio (OR)|1.72||||0.035|TWO_SIDED|95.0|1.05|2.9|||Regression, Logistic|We used an a priori threshold of p \< .05.||||2.90|1.05|.035
72535680|NCT02983305|144600861|EQUIVALENCE|Mann-Whitney U test was used to test equivalence of this outcome measure for the two study arms at baseline.||||||0.0001||||||P \< .05 was considered a priori to be statistically significant.|Wilcoxon (Mann-Whitney)|||Test of equivalence of visual field area at baseline.||||.0001
72535681|NCT02983305|144600861|EQUIVALENCE|Mann-Whitney U test was used to test equivalence of this outcome measure for the two study arms under intervention conditions.||||||0.0001||||||P \< .05 was considered a priori to be statistically significant.|Wilcoxon (Mann-Whitney)|||Test of equivalence of visual field area under intervention conditions.||||0.0001
72535682|NCT02983305|144600861|EQUIVALENCE|Mann-Whitney U test was used to test non-equivalence of this outcome measure for the two study arms under intervention conditions.||||||0.003||||||P \< .05 was considered a priori to be statistically significant.|Wilcoxon (Mann-Whitney)|||Comparison between study arms of the change in the visual field area (average of both eyes) detected between baseline and intervention.||||.003
72535683|NCT02983305|144600862|EQUIVALENCE|Mann-Whitney U test was used to test equivalence of this outcome measure for the two study arms at baseline.||||||0.38||||||P \< .05 was considered a priori to be statistically significant.|Wilcoxon (Mann-Whitney)|||Test of equivalence of gait speed at baseline.||||0.38
72535684|NCT02983305|144600862|EQUIVALENCE|Mann-Whitney U test was used to test equivalence of this outcome measure for the two study arms under intervention conditions.||||||0.27||||||P \< .05 was considered a priori to be statistically significant.|Wilcoxon (Mann-Whitney)|||Test of equivalence of gait speed under intervention conditions.||||0.27
72535685|NCT02983305|144600862|EQUIVALENCE|Mann-Whitney U test was used to test non-equivalence of this outcome measure for the two study arms under intervention conditions.||||||0.79||||||P \< .05 was considered a priori to be statistically significant.|Wilcoxon (Mann-Whitney)|||Comparison between study arms of the change in the gait speed detected between baseline and intervention.||||0.79
72535686|NCT01646268|144600864|SUPERIORITY_OR_OTHER||LS Means|-4.82|STANDARD_ERROR_OF_MEAN|1.2|<|0.0001|TWO_SIDED|95.0|-7.18|-2.45|||ANCOVA||Value describes the difference value of the mean change from baseline between Rotigotine and Placebo groups. The Value for this outcome was -4.6.|The null hypothesis (H0) is that there is no difference in the change in the sum of the score from the ADL and motor examination in the UPDRS (Parts II+II) between the active treatment and the placebo groups (i.e., the change from Baseline in the sum of the score from the ADL and motor examination in the UPDRS (Parts II+III) is the same for both groups).||-2.45|-7.18|<0.0001
72535687|NCT00461591|144600874|SUPERIORITY||Odds Ratio (OR)|0.76||||0.1068|TWO_SIDED|95.0|0.54|1.06|||Cochran-Mantel-Haenszel|||||1.06|0.54|0.1068
72573138|NCT03118570|144673093|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.387||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 12||||0.387
72573139|NCT03118570|144673093|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.093||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 18||||0.093
72535688|NCT00461591|144600875|SUPERIORITY||Hazard Ratio (HR)|0.77||||0.0412|TWO_SIDED|95.0|0.59|0.99|||Log Rank|||||0.99|0.59|0.0412
72535689|NCT02325414|144600883|SUPERIORITY||Median Difference (Final Values)|10.61||||0.05|TWO_SIDED||||||Mixed Models Analysis||||One-year data analysis were carried out using linear mixed-effects models. Covariate adjustments for baseline value of the corresponding outcome and ambulatory status (measured by WISCI) were performed by fitting these variables as fixed factors. The repeated measures were addressed using participant identification as random intercepts in the model.|||0.05
72573140|NCT03118570|144673093|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.156||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 18||||0.156
72573141|NCT03118570|144673093|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.324||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 18||||0.324
72408506|NCT02652624|144325570|OTHER||Difference in least square means|3.0||||0.84|TWO_SIDED|95.0|-27.0|34.0|||ANOVA||Difference in least squares means and its 95% CI were from ANOVA model with treatment group as a fixed effect in the model.|||34|-27|0.84
72535690|NCT02544607|144600887|OTHER||||||<|0.01|TWO_SIDED|95.0|||||t-test, 2 sided|||||||<0.01
72535691|NCT02544607|144600888|OTHER|||||||0.048|TWO_SIDED|95.0|||||t-test, 2 sided|||||||0.048
72535692|NCT02544607|144600889|OTHER|||||||0.003|TWO_SIDED|95.0|||||t-test, 2 sided|||||||0.003
72535693|NCT02544607|144600890|OTHER|||||||0.0499|TWO_SIDED|95.0|||||t-test, 2 sided|||||||.0499
72535694|NCT02544607|144600891|OTHER|||||||0.038|TWO_SIDED|95.0|||||t-test, 2 sided|||||||0.038
72535695|NCT00347776|144600925|SUPERIORITY||Cox Proportional Hazard|0.67||||0.047|TWO_SIDED|95.0|0.45|0.98|||Log Rank|||"The log rank test was done to compare the survival rates between the tetracycline arm and the azithromycin arms combined.~The Cox proportional hazard model was used to evaluate risk factors and adjust for confounding in predicting recurrence."||0.98|0.45|.047
72535696|NCT00347776|144600926|SUPERIORITY|||||||0.19|||||||Log Rank|||"We tried to evaluate if treating the immediate family members of the subject with oral azithromycin along with the subject had added advantage in reducing the rate of recurrent trichiasis in comparison to treating the subject alone with oral azithromycin post surgery.~The log rank test was done to compare the survival rates between the two intervention arms.The comparison results were expressed in person-years."||||0.19
72535697|NCT00347776|144600927|SUPERIORITY||Odds Ratio (OR)|0.63|||||TWO_SIDED|95.0|0.36|1.1|||Regression, Logistic||Comparison group was the tetracycline group.|Surgery was considered a failure if there was trichiasis recurrence at 6 week follow-up.||1.10|0.36|
72535698|NCT00299546|144600929|SUPERIORITY_OR_OTHER||||||<|0.001||||||A positive test is concluded if there is a significant difference between combined golimumab and placebo groups and at least one of the pair-wise comparisons at 0.05 level.|Cochran-Mantel-Haenszel|Stratified by baseline Methotrexate (MTX)||Null hypothesis: No difference in ACR 20 response at Wk 14 comparing Group 1 vs. Combined Groups 2 and 3. A sample size of 140 patients per group provides a \>90% power assuming 50% of patients used Methotrexate (MTX) at baseline and 30% ACR 20 response in placebo and 40\~55% ACR 20 response in golimumab groups.||||<0.001
72573142|NCT03118570|144673093|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.92||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 24||||0.920
72573143|NCT03118570|144673093|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.04||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 24||||0.040
72535699|NCT00299546|144600929|SUPERIORITY_OR_OTHER|||||||0.001||||||Test was performed because Group 1: Placebo was significantly different from Combined Groups 2 \& 3.|Cochran-Mantel-Haenszel|Stratified by baseline MTX||Null Hypothesis: No difference in ACR 20 response at Wk 14 between Group 1: Placebo and Group 2: 50 mg.||||0.001
72535700|NCT00299546|144600929|SUPERIORITY_OR_OTHER||||||<|0.001||||||Test was performed because Group 1: Placebo was significantly different from Combined Groups 2 \& 3.|Cochran-Mantel-Haenszel|Stratified by baseline MTX.||Null Hypothesis: No difference in ACR 20 response at Wk 14 between Group 1: Placebo and Group 3 :100 mg.||||<0.001
72535701|NCT00299546|144600930|SUPERIORITY_OR_OTHER|||||||0.003|||||||Cochran-Mantel-Haenszel|Stratified by baseline Methotrexate (MTX).||||||0.003
72535702|NCT00299546|144600930|SUPERIORITY_OR_OTHER|||||||0.021||||||Test was performed because Group 1: Placebo was significantly different from Combined Groups 2 \& 3.|Cochran-Mantel-Haenszel|Stratified by baseline MTX.||||||0.021
72535703|NCT00299546|144600930|SUPERIORITY_OR_OTHER|||||||0.002||||||Test was performed because Group 1: Placebo was significantly different from Combined Groups 2 \& 3.|Cochran-Mantel-Haenszel|Stratified by baseline MTX.||||||0.002
72535704|NCT00299546|144600931|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|Stratified by baseline Methorexate (MTX).||||||<0.001
72535705|NCT00299546|144600931|SUPERIORITY_OR_OTHER||||||<|0.001||||||Test was performed because Group 1: Placebo was significantly different from Combined Groups 2 \& 3.|Cochran-Mantel-Haenszel|Stratified by baseline MTX.||||||<0.001
72535706|NCT00299546|144600931|SUPERIORITY_OR_OTHER||||||<|0.001||||||Test was performed because Group 1: Placebo was significantly different from Combined Groups 2 \& 3.|Cochran-Mantel-Haenszel|Stratified by baseline MTX.||||||<0.001
72535707|NCT00299546|144600932|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|Stratified by baseline Methotrexate (MTX).||||||<0.001
72535708|NCT00299546|144600932|SUPERIORITY_OR_OTHER|||||||0.002||||||Test was performed because Group 1: Placebo was significantly different from Combined Groups 2 \& 3.|Cochran-Mantel-Haenszel|Stratified by baseline MTX.||||||0.002
72535709|NCT00299546|144600932|SUPERIORITY_OR_OTHER||||||<|0.001||||||Test was performed because Group 1: Placebo was significantly different from Combined Groups 2 \& 3.|Cochran-Mantel-Haenszel|Stratified by baseline MTX.||||||<0.001
72573144|NCT03118570|144673093|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.643||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 24||||0.643
72408507|NCT01560624|144325577|SUPERIORITY||Hazard Ratio (HR)|0.74||||0.0275|TWO_SIDED|95.0|0.56|0.97|||Cox proportion-hazard model|||||0.97|0.56|0.0275
72408508|NCT01560624|144325577|SUPERIORITY|||||||0.0391|||||||Log Rank|||||||0.0391
72408509|NCT01560624|144325578|SUPERIORITY||Hodges Lehmann estimate location shift|7.0||||0.0913|TWO_SIDED|95.0|0.0|16.0|||ANCOVA|||||16.0|0|0.0913
72535710|NCT00299546|144600933|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA on van der Waerden normal scores.|Stratified by baseline Methotrexate (MTX).||||||<0.001
72535711|NCT00299546|144600933|SUPERIORITY_OR_OTHER||||||<|0.001||||||Test was performed because Group 1: Placebo was significantly different from Combined Groups 2 \& 3.|ANOVA on van der Waerden normal scores.|Stratified by baseline MTX.||||||<0.001
72535712|NCT00299546|144600933|SUPERIORITY_OR_OTHER||||||<|0.001||||||Test was performed because Group 1: Placebo was significantly different from Combined Groups 2 \& 3.|ANOVA on van der Waerden normal scores.|Stratified by baseline MTX.||||||<0.001
72535713|NCT00518531|144600965|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|10.5||||0.0259|TWO_SIDED|95.0|1.3|19.7||All statistical hypothesis tests were conducted at the 0.05 significance level. No adjustment was employed for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by center and prior osteoporotic fracture|Positive values for absolute risk reduction favor denosumab.|||19.7|1.3|0.0259
72408510|NCT01560624|144325579|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
72408511|NCT01560624|144325580|SUPERIORITY|||||||0.0028|||||||Fisher Exact|||||||0.0028
72408512|NCT01797536|144325581|SUPERIORITY_OR_OTHER||Geometric Mean Ratio (GMR)|0.61|||||TWO_SIDED|90.0|0.34|1.08|||||GMR= Mild Hepatic Insufficiency Geometric Mean (GM) divided by Healthy Control GM|Back-transformed least-squares mean and confidence interval from linear fixed effect model performed on natural log-transformed values||1.08|0.34|
72408513|NCT01797536|144325581|SUPERIORITY_OR_OTHER||GMR|0.72|||||TWO_SIDED|90.0|0.4|1.31|||||GMR = Moderate Hepatic Insufficiency GM divided by Healthy Control GM|Back-transformed least-squares mean and confidence interval from linear fixed effect model performed on natural log-transformed values||1.31|0.40|
72408514|NCT01797536|144325581|SUPERIORITY_OR_OTHER||GMR|0.88|||||TWO_SIDED|90.0|0.48|1.61|||||GMR = Severe Hepatic Insufficiency GM divided by Healthy Control GM|Back-transformed least-squares mean and confidence interval from linear fixed effect model performed on natural log-transformed values||1.61|0.48|
72408515|NCT01797536|144325582|SUPERIORITY_OR_OTHER||GMR|0.6|||||TWO_SIDED|90.0|0.34|1.05|||||GMR = Mild Hepatic Insufficiency GM divided by Healthy Control GM|Back-transformed least-squares mean and confidence interval from linear fixed effect model performed on natural log-transformed values||1.05|0.34|
72408516|NCT01797536|144325582|SUPERIORITY_OR_OTHER||GMR|0.64|||||TWO_SIDED|90.0|0.35|1.14|||||GMR = Moderate Hepatic Insufficiency GM divided by Healthy Control GM|Back-transformed least-squares mean and confidence interval from linear fixed effect model performed on natural log-transformed values||1.14|0.35|
72408517|NCT01797536|144325582|SUPERIORITY_OR_OTHER||GMR|0.63|||||TWO_SIDED|90.0|0.35|1.13|||||GMR = Severe Hepatic Insufficiency GM divided by Healthy Control GM|Back-transformed least-squares mean and confidence interval from linear fixed effect model performed on natural log-transformed values||1.13|0.35|
72408518|NCT01797536|144325583|SUPERIORITY_OR_OTHER||GMR|0.58|||||TWO_SIDED|90.0|0.32|1.05|||||GMR = Mild Hepatic Insufficiency GM divided by Healthy Control GM|Back-transformed least-squares mean and confidence interval from linear fixed effect model performed on natural log-transformed values||1.05|0.32|
72408519|NCT01797536|144325583|SUPERIORITY_OR_OTHER||GMR|0.64|||||TWO_SIDED|90.0|0.35|1.14|||||GMR = Moderate Hepatic Insufficiency GM divided by Healthy Control GM|Back-transformed least-squares mean and confidence interval from linear fixed effect model performed on natural log-transformed values||1.14|0.35|
72408520|NCT01797536|144325583|SUPERIORITY_OR_OTHER||GMR|0.58|||||TWO_SIDED|90.0|0.32|1.08|||||GMR = Severe Hepatic Insufficiency GM divided by Healthy Control GM|Back-transformed least-squares mean and confidence interval from linear fixed effect model performed on natural log-transformed values||1.08|0.32|
72408521|NCT01797536|144325584|SUPERIORITY_OR_OTHER||GMR|0.61|||||TWO_SIDED|90.0|0.34|1.08|||||GMR = Mild Hepatic Insufficiency GM divided by Healthy Control GM|Back-transformed least-squares mean and confidence interval from linear fixed effect model performed on natural log-transformed values||1.08|0.34|
72408522|NCT01797536|144325584|SUPERIORITY_OR_OTHER||GMR|0.69|||||TWO_SIDED|90.0|0.38|1.25|||||GMR = Moderate Hepatic Insufficiency GM divided by Healthy Control GM|Back-transformed least-squares mean and confidence interval from linear fixed effect model performed on natural log-transformed values||1.25|0.38|
72408523|NCT01797536|144325584|SUPERIORITY_OR_OTHER||GMR|0.78|||||TWO_SIDED|90.0|0.43|1.43|||||GMR = Severe Hepatic Insufficiency GM divided by Healthy Control GM|Back-transformed least-squares mean and confidence interval from linear fixed effect model performed on natural log-transformed values||1.43|0.43|
72408524|NCT03228680|144325596|NON_INFERIORITY|The pre-specified non-inferiority (NI) margin was -3.0 oocytes. The NI was evaluated based on the two-sided 95% CI from the ANOVA on 'number of oocytes retrieved' with treatment and AMH stratum as fixed factors.|Mean Difference (Final Values)|-1.2|||||TWO_SIDED|95.0|-2.3|-0.1|||||If the lower bound of 95% CI was well above pre-specified NI limit of -3.0 oocytes, then NI of FE 999049 to FOLLISTIM with respect to number of oocytes retrieved in women undergoing controlled ovarian stimulation would be demonstrated|Mean number of oocytes retrieved.||-0.1|-2.3|
72408525|NCT03228680|144325597|OTHER||Risk Difference (RD)|1.6|||||TWO_SIDED|95.0|-7.5|10.6|||||The difference (FE 999049-FOLLISTIM) in rates was estimated and a two-sided 95% Cl was constructed using the Mantel-Haenszel method to combine results across AMH strata.|Percentage of participants with at least one gestational sac 5-6 weeks after transfer.||10.6|-7.5|
72408526|NCT03228680|144325598|OTHER||Risk Difference (RD)|0.0|||||TWO_SIDED|95.0|-9.5|9.6|||||The difference (FE 999049-FOLLISTIM) in rates was estimated and a two-sided 95% Cl was constructed using the Mantel-Haenszel method to combine results across AMH strata.|Percentage of participants with positive beta-hCG.||9.6|-9.5|
72408527|NCT03228680|144325599|OTHER||Risk Difference (RD)|2.0|||||TWO_SIDED|95.0|-6.7|10.8|||||The difference (FE 999049-FOLLISTIM) in rates was estimated and a two-sided 95% Cl was constructed using the Mantel-Haenszel method to combine results across AMH strata.|Percentage of participants with vital pregnancy.||10.8|-6.7|
72408528|NCT03228680|144325600|OTHER||Risk Difference (RD)|1.9|||||TWO_SIDED|95.0|-8.9|12.8|||||The difference (FE 999049-FOLLISTIM) in rates was estimated and a two-sided 95% Cl was constructed using the Mantel-Haenszel method to combine results across AMH strata.|Percentage of implanted embryos 5-6 weeks after transfer.||12.8|-8.9|
72408529|NCT03228680|144325602|SUPERIORITY|||||||0.244||||||P-value was based on likelihood ratio chi-square test.|Regression, Logistic|The model included treatment and AMH stratum (\<15 pmol/L and ≥15 pmol/L) as fixed factors.||Proportion of participants with blastocyst transfer cancellation.||||0.244
72535714|NCT00518531|144600966|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|30.9|||<|0.0001|TWO_SIDED|95.0|20.6|41.3||All statistical hypothesis tests were conducted at the 0.05 significance level. No adjustment was employed for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by center and prior osteoporotic fracture|Positive values for absolute risk reduction favor denosumab.|||41.3|20.6|<0.0001
72408530|NCT03228680|144325603|SUPERIORITY|||||||0.254||||||P-value was based on likelihood ratio chi-square test.|Regression, Logistic|The model included treatment and AMH stratum (\<15 pmol/L and ≥15 pmol/L) as fixed factors.||Proportion of participants with \<4 oocytes retrieved (low response).||||0.254
72408531|NCT03228680|144325603|SUPERIORITY|||||||0.041||||||P-value was based on likelihood ratio test.|Regression, Logistic|The model included treatment and AMH stratum (\<15 pmol/L and ≥15 pmol/L) as fixed factors.||Proportion of participants with 4-7 oocytes retrieved (moderate response).||||0.041
72408532|NCT03228680|144325603|SUPERIORITY|||||||0.705||||||P-value was based on likelihood ratio test.|Regression, Logistic|The model included treatment and AMH stratum (\<15 pmol/L and ≥15 pmol/L) as fixed factors.||Proportion of participants with 8-14 oocytes retrieved (targeted response).||||0.705
72408533|NCT03228680|144325603|SUPERIORITY|||||||0.183||||||P-value was based on likelihood ratio test.|Regression, Logistic|The model included treatment and AMH stratum (\<15 pmol/L and ≥15 pmol/L) as fixed factors.||Proportion of participants with 15-19 oocytes retrieved (hyperresponse).||||0.183
72535715|NCT00518531|144600967|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|11.0||||0.0138|TWO_SIDED|95.0|2.2|19.7|||Cochran-Mantel-Haenszel|Stratified by center and prior osteoporotic fracture.|Positive values for absolute risk reduction favor denosumab.|||19.7|2.2|0.0138
72535716|NCT00518531|144600968|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|27.7|||<|0.0001|TWO_SIDED|95.0|17.6|37.7|||Cochran-Mantel-Haenszel|Stratified by center and prior osteoporotic fracture.|Positive values for absolute risk reduction favor denosumab.|||37.7|17.6|<0.0001
72535717|NCT00518531|144600969|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|9.8||||0.0291|TWO_SIDED|95.0|1.1|18.5|||Cochran-Mantel-Haenszel|Stratified by center and prior osteoporotic fracture.|Positive values for absolute risk reduction favor denosumab.|||18.5|1.1|0.0291
72535718|NCT00518531|144600970|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|27.4|||<|0.0001|TWO_SIDED|95.0|18.1|36.7|||Cochran-Mantel-Haenszel|Stratified by center and prior osteoporotic fracture.|Positive values for absolute risk reduction favor denosumab.|||36.7|18.1|<0.0001
72535719|NCT03681769|144600986|EQUIVALENCE|Non-equivalence determined by p\<.05.||||||0.83||||||No site X time interaction (F12,270 = 0.614, p = 0.830).|Mixed Models Analysis|||||||.83
72535720|NCT03681769|144600987|OTHER|||||||0.53|||||||t-test, 2 sided|||||||.53
72535721|NCT01817764|144600988|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.074|||<|0.001|TWO_SIDED|95.0|0.038|0.11|||ANCOVA|||||0.110|0.038|<0.001
72535722|NCT04888377|144600990|NON_INFERIORITY|The primary hypothesis of non-inferiority was tested by calculating the mean difference between treatment arms and its associated 90% confidence interval for the primary outcome. If the lower bound of the 90% confidence interval was greater than -4, then LDA was assumed to be non-inferior to placebo. If non-inferiority were assumed, a one-sided t-test would test the benefit of LDA compared to placebo. All models controlled for site as the original randomization stratification factor.|Mean Difference (Final Values)|-0.8||||0.25|TWO_SIDED|95.0|-2.2|0.6||For each outcome, the adjusted mean difference between treatment groups and the associated 95% confidence interval based on an ANCOVA model is presented.|ANCOVA||Mean difference is Aspirin-Placebo.|Assuming a non-inferiority margin of 4 points in the BSID-III cognitive score as clinically significant, and a true effect of LDA of not more than a 1 point decrease, a total sample size of 620 was determined to provide 80% power for a one-sided test for non-inferiority with a type I error of 5%. To test this secondary hypothesis, the sample size also provided over 90% power, at a two-sided type I error of 5%, to detect a difference of 4 points between LDA and placebo based on a two-sided test.||0.6|-2.2|0.25
72535723|NCT00526162|144601009|OTHER||percentage|0.0|||<|0.03|ONE_SIDED|97.0||||Using a confidence interval of 97%, the exact binomial upper confidence bound was 9.5% which is lower than the 10% set for the primary safety objective. Therefore, the actual p-value has not been calculated further.|One proportion binomial exact||The confidence interval was calculated based on 35 patients who completed 1-month follow-up at interim analysis.|||||<0.03
72408534|NCT03228680|144325603|SUPERIORITY|||||||0.03||||||P-value was based on likelihood ratio chi-square test.|Regression, Logistic|The model included treatment and AMH stratum (\<15 pmol/L and ≥15 pmol/L) as fixed factors.||Proportion of participants with \>= (more than equal to) 20 oocytes retrieved (severe hyperresponse).||||0.030
72535724|NCT04259905|144601109|SUPERIORITY||Cohen's d|0.85|||||TWO_SIDED|||||||||||||
72535725|NCT04259905|144601110|SUPERIORITY||Cohen's d|1.29|||||TWO_SIDED|||||||||||||
72535726|NCT04259905|144601111|SUPERIORITY||Cohen's d|1.06|||||TWO_SIDED|||||||||||||
72535727|NCT00762073|144601129|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.239||||0.5282|TWO_SIDED|||||p-values comparing each active treatment group to placebo were determined by a logistic regression analysis with treatment (all four groups) and age as main effects.|Regression, Logistic|||||||0.5282
72535728|NCT00762073|144601129|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|18.86||||0.0092|TWO_SIDED|||||p-values comparing each active treatment group to placebo were determined by a logistic regression analysis with treatment (all four groups) and age as main effects.|Regression, Logistic|||||||0.0092
72535729|NCT00762073|144601129|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|15.009||||0.0174|TWO_SIDED|||||p-values comparing each active treatment group to placebo were determined by a logistic regression analysis with treatment (all four groups) and age as main effects.|Regression, Logistic|||||||0.0174
72535730|NCT00762073|144601130|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1786|TWO_SIDED|||||p-values were determined by a logistic regression analysis with treatment (all four groups) and age group as main effects.|Regression, Logistic|||||||0.1786
72535731|NCT00762073|144601130|SUPERIORITY_OR_OTHER_LEGACY|||||||0.009|TWO_SIDED|||||p-values were determined by a logistic regression analysis with treatment (all four groups) and age group as main effects.|Regression, Logistic|||||||0.0090
72535732|NCT00762073|144601130|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0001|TWO_SIDED|||||p-values were determined by a logistic regression analysis with treatment (all four groups) and age group as main effects.|Regression, Logistic|||||||0.0001
72535733|NCT00762073|144601131|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4959|TWO_SIDED|||||p-values were determined by a logistic regression analysis with treatment (all four groups) and age group as main effects.|Regression, Logistic|||||||0.4959
72535734|NCT00762073|144601131|SUPERIORITY_OR_OTHER_LEGACY|||||||0.004|TWO_SIDED|||||p-values were determined by a logistic regression analysis with treatment (all four groups) and age group as main effects.|Regression, Logistic|||||||0.0040
72535735|NCT00762073|144601131|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED|||||p-values were determined by a logistic regression analysis with treatment (all four groups) and age group as main effects.|Regression, Logistic|||||||<0.0001
72535736|NCT00762073|144601132|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0108|TWO_SIDED|||||p-values comparing percent change from baseline for each active treatment group to placebo were determined by an ANCOVA model with treatment and age strata as main effects and baseline as a covariate.|ANCOVA|||||||0.0108
72535737|NCT00762073|144601132|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0208|TWO_SIDED|||||p-values comparing percent change from baseline for each active treatment group to placebo were determined by an ANCOVA model with treatment and age strata as main effects and baseline as a covariate.|ANCOVA|||||||0.0208
72535738|NCT00762073|144601132|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED|||||p-values comparing percent change from baseline for each active treatment group to placebo were determined by an ANCOVA model with treatment and age strata as main effects and baseline as a covariate.|ANCOVA|||||||<0.0001
72535739|NCT00762073|144601133|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1095|TWO_SIDED|||||p-values comparing each active treatment group to placebo were determined by an ANCOVA model with treatment and age strata as main effects and baseline as a covariate|ANCOVA|||||||0.1095
72535740|NCT00762073|144601133|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0264|TWO_SIDED|||||p-values comparing each active treatment group to placebo were determined by an ANCOVA model with treatment and age strata as main effects and baseline as a covariate|ANCOVA|||||||0.0264
72535741|NCT00762073|144601133|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|TWO_SIDED|||||p-values comparing each active treatment group to placebo were determined by an ANCOVA model with treatment and age strata as main effects and baseline as a covariate|ANCOVA|||||||0.0010
72408535|NCT03228680|144325604|SUPERIORITY|||||||0.893||||||P-value was based on likelihood ratio chi-square test.|Chi-squared|||Proportion of participants with extreme ovarian responses: AMH \< 15 pmol/L (\<4 oocytes retrieved)||||0.893
72408536|NCT03228680|144325604|SUPERIORITY|||||||0.002||||||P-value was based on likelihood ratio chi-square test.|Chi-squared|||Proportion of participants with extreme ovarian responses: AMH \>= 15 pmol/L (\>=15 oocytes retrieved)||||0.002
72408537|NCT03228680|144325604|SUPERIORITY|||||||0.021||||||P-value based on likelihood ratio chi-square test.|Chi-squared|||Proportion of participants with extreme ovarian responses: AMH \>= 15 pmol/L (\>=20 oocytes retrieved)||||0.021
72535742|NCT00762073|144601134|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3769|TWO_SIDED|||||p-values comparing each active treatment group to placebo were determined by a logistic regression analysis with treatment (all four groups) and age as main effects.|Regression, Logistic|||||||0.3769
72535743|NCT00762073|144601134|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9363|TWO_SIDED|||||p-values comparing each active treatment group to placebo were determined by a logistic regression analysis with treatment (all four groups) and age as main effects.|Regression, Logistic|||||||0.9363
72535744|NCT00762073|144601134|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1235|TWO_SIDED|||||p-values comparing each active treatment group to placebo were determined by a logistic regression analysis with treatment (all four groups) and age as main effects.|Regression, Logistic|||||||0.1235
72535745|NCT00762073|144601135|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3444|TWO_SIDED|||||p-values comparing each active treatment group to placebo were determined by a logistic regression analysis with treatment (all four groups) and age as main effects.|Regression, Logistic|||||||0.3444
72535746|NCT00762073|144601135|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9258|TWO_SIDED|||||p-values comparing each active treatment group to placebo were determined by a logistic regression analysis with treatment (all four groups) and age as main effects.|Regression, Logistic|||||||0.9258
72535747|NCT00762073|144601135|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3215|TWO_SIDED|||||p-values comparing each active treatment group to placebo were determined by a logistic regression analysis with treatment (all four groups) and age as main effects.|Regression, Logistic|||||||0.3215
72535748|NCT00762073|144601136|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6729|TWO_SIDED|||||p-values comparing percent change from Baseline for each active treatment group to placebo were determined by an ANCOVA model with treatment and age strata as main effects and baseline as a covariate.|ANCOVA|||||||0.6729
72535749|NCT00762073|144601136|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8894|TWO_SIDED|||||p-values comparing percent change from Baseline for each active treatment group to placebo were determined by an ANCOVA model with treatment and age strata as main effects and baseline as a covariate.|ANCOVA|||||||0.8894
72535750|NCT00762073|144601136|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1532|TWO_SIDED|||||p-values comparing percent change from Baseline for each active treatment group to placebo were determined by an ANCOVA model with treatment and age strata as main effects and baseline as a covariate.|ANCOVA|||||||0.1532
72535751|NCT00762073|144601137|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4197|TWO_SIDED|||||p-values comparing each active treatment group to placebo were determined by an ANCOVA model with treatment and age strata as main effects and baseline as a covariate.|ANCOVA|||||||0.4197
72535752|NCT00762073|144601137|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9787|TWO_SIDED|||||p-values comparing each active treatment group to placebo were determined by an ANCOVA model with treatment and age strata as main effects and baseline as a covariate.|ANCOVA|||||||0.9787
72535753|NCT00762073|144601137|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8987|TWO_SIDED|||||p-values comparing each active treatment group to placebo were determined by an ANCOVA model with treatment and age strata as main effects and baseline as a covariate.|ANCOVA|||||||0.8987
72535754|NCT00491322|144601145|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
72535755|NCT00602667|144601155|OTHER||Hazard Ratio (HR)|4.99|||||TWO_SIDED|95.0|1.17|21.23||||||The historical control included 10 medulloblastoma patients treated during 1998-2006 who would have been classified as intermediate risk according to SJYC07 criteria (section 13.1.3 of protocol).||21.23|1.17|
72408538|NCT03228680|144325606|SUPERIORITY|||||||0.017||||||P-value was based on likelihood ratio chi-square test.|Regression, Logistic|The model included treatment and AMH stratum (\<15 pmol/L and ≥15 pmol/L) as fixed factors.||Proportions of participants with early OHSS (any grade).||||0.017
72408539|NCT03228680|144325606|SUPERIORITY|||||||0.035||||||P-value was based on likelihood ratio chi-square test.|Regression, Logistic|The model included treatment and AMH stratum (\<15 pmol/L and ≥15 pmol/L) as fixed factors.||Proportion of participants with early OHSS (moderate/severe).||||0.035
72408540|NCT03228680|144325606|SUPERIORITY|||||||0.006||||||P-value was based on likelihood ratio chi-square test.|Regression, Logistic|The model included treatment and AMH stratum (\<15 pmol/L and ≥15 pmol/L) as fixed factors.||Proportion of participants with early OHSS (any grade) and/or preventive interventions.||||0.006
72408541|NCT03228680|144325606|SUPERIORITY|||||||0.009||||||P-value was based on likelihood ratio chi-square test.|Regression, Logistic|The model included treatment and AMH stratum (\<15 pmol/L and ≥15 pmol/L) as fixed factors.||Proportion of participants with early OHSS (moderate/severe) and/or preventive interventions.||||0.009
72408542|NCT03228680|144325607|SUPERIORITY|||||||0.968||||||P-value was based on likelihood ratio chi-square test.|Regression, Logistic|The model included treatment and AMH stratum (\<15 pmol/L and ≥15 pmol/L) as fixed factors.||Proportions of participants with late OHSS (any grade).||||0.968
72408543|NCT03228680|144325607|SUPERIORITY|||||||0.582||||||P-value was based on likelihood ratio chi-square test.|Regression, Logistic|The model included treatment and AMH stratum (\<15 pmol/L and ≥15 pmol/L) as fixed factors.||Proportions of participants with late OHSS (moderate/severe).||||0.582
72535756|NCT00602667|144601155|OTHER||Hazard Ratio (HR)|0.86|||||TWO_SIDED|95.0|0.4|1.84||||||The historical control included 14 medulloblastoma patients treated during 1998-2006 who would have been classified as high risk according to SJYC07 criteria (section 13.1.3 of protocol).||1.84|0.40|
72535757|NCT00602667|144601156|OTHER||Hazard Ratio (HR)|1.85|||||TWO_SIDED|95.0|0.42|8.22||||||The historical control included 10 medulloblastoma patients treated during 1998-2006 who would have been classified as intermediate risk according to SJYC07 criteria (section 13.1.3 of protocol).||8.22|0.42|
72535758|NCT00602667|144601156|OTHER||Hazard Ratio (HR)|0.75|||||TWO_SIDED|95.0|0.31|1.79||||||The historical control included 14 medulloblastoma patients treated during 1998-2006 who would have been classified as high risk according to SJYC07 criteria (section 13.1.3 of protocol).||1.79|0.31|
72535759|NCT04410978|144601244|SUPERIORITY|A hierarchical testing procedure was used to control the overall type I error.|Relative risk|1.061||||0.6691|TWO_SIDED|95.0|0.808|1.393||Threshold for significance at 2-sided 0.05 level.|Chi-squared|||Analysis was performed using negative binomial model with number of adjudicated relapses onset between randomization date and EOS date as the response variable, treatment group, Gadolinium (Gd)-enhancing T1 lesions at baseline (presence, absence), expanded disability status scale (EDSS) strata (\<4, \>=4) and geographic region (United States \[US\], non-US) as covariates, and log transformed observation duration as the offset variable.||1.393|0.808|0.6691
72535760|NCT04410978|144601245|SUPERIORITY|A hierarchical testing procedure was used to control the overall type I error.|Hazard Ratio (HR)|0.85||||0.4888|TWO_SIDED|95.0|0.565|1.278||Derived from log-rank test with stratification of EDSS strata (\<4, \>=4), geographic region (US, non-US).|Log Rank|||Analysis was performed using Cox proportional-hazards model with robust variance estimation. Covariates were treatment group, Gd-enhancing T1 lesions at baseline (presence, absence), EDSS strata (\<4, \>=4), geographic region (US, non-US).||1.278|0.565|0.4888
72408544|NCT03228680|144325608|SUPERIORITY|||||||0.198||||||2-sided|van Elteren test|P-value was based on van Elteren test adjusted for AMH strata.||The number of follicles on stimulation Day 6 was analyzed.||||0.198
72408545|NCT03228680|144325609|SUPERIORITY|||||||0.036||||||2-sided|van Elteren test|P-value was based on van Elteren test adjusted for AMH strata.||The number of follicles at end-of-stimulation was analyzed.||||0.036
72408546|NCT03228680|144325610|SUPERIORITY|||||||0.592||||||2-sided|van Elteren test|P-value was based on van Elteren test adjusted for AMH strata.||The average size of 3 largest follicles was analyzed.||||0.592
72535761|NCT04410978|144601246|SUPERIORITY|A hierarchical testing procedure was used to control the overall type I error.|Hazard Ratio (HR)|0.819||||0.2991|TWO_SIDED|95.0|0.582|1.151||Derived from log-rank test with stratification of EDSS strata (\<4, \>=4), geographic region (US, non-US).|Log Rank|||Analysis was performed using Cox proportional-hazards model with robust variance estimation. Covariates were treatment group, Gd-enhancing T1 lesions at baseline (presence, absence), EDSS strata (\<4, \>=4), geographic region (US, non-US).||1.151|0.582|0.2991
72535762|NCT04410978|144601247|SUPERIORITY|A hierarchical testing procedure was used to control the overall type I error.|Relative risk|1.084||||0.4575|TWO_SIDED|95.0|0.876|1.342|||Chi-squared|||Analysis was performed using negative binomial model with the number of new and/or enlarging T2-hyperintense lesions between randomization date and EOS date as the response variable, treatment group, baseline T2-hyperintense lesion count, EDSS strata (\<4, \>=4) and geographic region (US, non-US) as covariates, and log transformed observation duration as the offset variable.||1.342|0.876|0.4575
72573145|NCT03118570|144673094|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.285||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 6||||0.285
72535763|NCT04410978|144601248|SUPERIORITY|A hierarchical testing procedure was used to control the overall type I error.|Relative risk|1.86||||0.0001|TWO_SIDED|95.0|1.358|2.548|||Chi-squared|||Analysis was performed using negative binomial model with the number of new Gd-enhancing T1-hyperintense lesions between randomization date and EOS date as the response variable, treatment group, Gd-enhancing T1 lesions at baseline (presence, absence), EDSS strata (\<4, \>=4) and geographic region (US, non-US) as covariates, and log transformed number of MRI scans as the offset variable.||2.548|1.358|0.0001
72408547|NCT03228680|144325611|SUPERIORITY|||||||0.286||||||2-sided|van Elteren test|P-value was based on van Elteren test adjusted for AMH strata.||The average size of 3 largest follicles was analyzed.||||0.286
72408548|NCT03228680|144325612|SUPERIORITY|||||||0.395||||||2-sided|van Elteren test|P-value was based on van Elteren test adjusted for AMH strata.||The fertilization rate (number of oocytes with 2 pronuclei divided by the number of oocytes retrieved) was analyzed.||||0.395
72408549|NCT03228680|144325613|SUPERIORITY|||||||0.001||||||2-sided|van Elteren test|P-value was based on van Elteren test adjusted for AMH strata.||The number of embryos on Day 3 was analyzed.||||0.001
72408550|NCT03228680|144325613|SUPERIORITY|||||||0.004||||||2-sided|van Elteren test|P-value was based on van Elteren test adjusted for AMH strata.||The number of good-quality embryos on Day 3 was analyzed.||||0.004
72408551|NCT03228680|144325614|SUPERIORITY||||||<|0.001||||||2-sided|van Elteren test|P-value was based on van Elteren test adjusted for AMH strata.||The number of blastocysts on Day 5 was analyzed.||||<.001
72408552|NCT03228680|144325614|SUPERIORITY||||||<|0.001||||||2-sided|van Elteren test|P-value was based on van Elteren test adjusted for AMH strata.||The number of good-quality blastocysts on Day 5 was analyzed.||||<0.001
72535764|NCT04410978|144601249|SUPERIORITY|A hierarchical testing procedure was used to control the overall type I error.|Least square (LS) mean difference|0.035||||0.432|TWO_SIDED|95.0|-0.053|0.124|||MMRM|||Covariates in the mixed-effect model with repeated measures (MMRM) were treatment group, EDSS strata (\<4, \>=4), geographic region (US, non-US), visit, treatment by visit interaction, baseline value, and baseline value-by-visit interaction.||0.124|-0.053|0.4320
72535765|NCT04410978|144601250|SUPERIORITY|A hierarchical testing procedure was used to control the overall type I error.|LS mean difference|1.873||||0.0675|TWO_SIDED|95.0|-0.135|3.88|||MMRM|||Covariates in the MMRM were treatment group, EDSS strata (\<4, \>=4), geographic region (US, non-US), visit, treatment by visit interaction, baseline value, and baseline value-by-visit interaction.||3.880|-0.135|0.0675
72535766|NCT04410978|144601251|SUPERIORITY|A hierarchical testing procedure was used to control the overall type I error.|Hazard Ratio (HR)|0.831||||0.3594|TWO_SIDED|95.0|0.554|1.245||Derived from log-rank test with stratification of EDSS strata (\<4, \>=4), geographic region (US, non-US).|Log Rank|||Analysis was performed using Cox proportional-hazards model with robust variance estimation. Covariates were treatment group, Gd-enhancing T1 lesions at baseline (presence, absence), EDSS strata (\<4, \>=4), geographic region (US, non-US).||1.245|0.554|0.3594
72535767|NCT04410978|144601252|SUPERIORITY|A hierarchical testing procedure was used to control the overall type I error.|LS mean difference|0.196||||0.0002|TWO_SIDED|95.0|0.093|0.298|||MMRM|||Covariates in the MMRM were treatment group, EDSS strata (\<4, \>=4), geographic region (US, non-US), visit, treatment by visit interaction, cube root transformed Month 6 brain volume, and cube root transformed Month 6 brain volume-by-visit interaction.||0.298|0.093|0.0002
72408553|NCT03228680|144325615|SUPERIORITY||Mean ratio|1.03||||0.228|TWO_SIDED|95.0|0.98|1.09||The P-value corresponds to the two-sided F-test of treatment effect.|ANCOVA|The ANCOVA model included treatment and AMH stratum (\<15 pmol/L and ≥15 pmol/L) as fixed factors and log-baseline as covariate.|Mean ratio is equal to FE 999049/FOLLISTIM.|Circulating levels of FSH on stimulation Day 6.||1.09|0.98|0.228
72408554|NCT03228680|144325615|SUPERIORITY||Mean ratio|0.97||||0.777|TWO_SIDED|95.0|0.81|1.17||The P-value corresponds to the two-sided F-test of treatment effect.|ANCOVA|The ANCOVA model included treatment and AMH stratum (\<15 pmol/L and ≥15 pmol/L) as fixed factors and log-baseline as covariate.|Mean ratio is equal to FE 999049/FOLLISTIM.|Circulating levels of LH on stimulation Day 6.||1.17|0.81|0.777
72408555|NCT03228680|144325616|SUPERIORITY||Mean ratio|0.89|||<|0.001|TWO_SIDED|95.0|0.84|0.94||The P-value corresponds to the two-sided F-test of treatment effect.|ANCOVA|The ANCOVA model included treatment and AMH stratum (\<15 pmol/L and ≥15 pmol/L) as fixed factors and log-baseline as covariate.|Mean ratio is equal to FE 999049/FOLLISTIM.|Circulating levels of FSH at end-of-stimulation.||0.94|0.84|<0.001
72408556|NCT03228680|144325616|SUPERIORITY||Mean ratio|1.17||||0.057|TWO_SIDED|95.0|1.0|1.39||The P-value corresponds to the two-sided F-test of treatment effect.|ANCOVA|The ANCOVA model included treatment and AMH stratum (\<15 pmol/L and ≥15 pmol/L) as fixed factors and log-baseline as covariate.|Mean ratio is equal to FE 999049/FOLLISTIM.|Circulating levels of LH at end-of-stimulation.||1.39|1.00|0.057
72535768|NCT05153629|144601262|OTHER|||||||0.93||||||A p-value less than the a priori threshold of 0.05 is considered statistically significant.|t-test, 2 sided|||Analysis of back pain.||||0.93
72408557|NCT03228680|144325617|SUPERIORITY||Mean ratio|0.81||||0.002|TWO_SIDED|95.0|0.71|0.93||The P-value corresponds to the two-sided F-test of treatment effect.|ANCOVA|The ANCOVA model included treatment and AMH stratum (\<15 pmol/L and ≥15 pmol/L) as fixed factors and log-baseline as covariate.|Mean ratio is equal to FE 999049/FOLLISTIM.|Circulating levels of estradiol on stimulation Day 6.||0.93|0.71|0.002
72408558|NCT03228680|144325618|SUPERIORITY||Mean ratio|0.85||||0.003|TWO_SIDED|95.0|0.76|0.95||The P-value corresponds to the two-sided F-test of treatment effect.|ANCOVA|The ANCOVA model included treatment and AMH stratum (\<15 pmol/L and ≥15 pmol/L) as fixed factors and log-baseline as covariate.|Mean ratio is equal to FE 999049/FOLLISTIM.|Circulating levels of estradiol at end-of-stimulation.||0.95|0.76|0.003
72535769|NCT05153629|144601262|OTHER|||||||0.76||||||A p-value less than the a priori threshold of 0.05 is considered statistically significant.|t-test, 2 sided|||Analysis of abdominal/groin pain.||||0.76
72535770|NCT05153629|144601262|OTHER|||||||0.56||||||A p-value less than the a priori threshold of 0.05 is considered statistically significant.|t-test, 2 sided|||Analysis of pain frequency.||||0.56
72535771|NCT05153629|144601262|OTHER|||||||0.26||||||A p-value less than the a priori threshold of 0.05 is considered statistically significant.|t-test, 2 sided|||Analysis of nausea intensity.||||0.26
72535772|NCT05153629|144601263|OTHER|||||||0.55||||||A p-value less than the a priori threshold of 0.05 is considered statistically significant.|t-test, 2 sided|||Analysis of difference in back pain.||||0.55
72535773|NCT05153629|144601263|OTHER|||||||0.28||||||A p-value less than the a priori threshold of 0.05 is considered statistically significant.|t-test, 2 sided|||Analysis of difference in abdominal/groin pain.||||0.28
72535774|NCT05153629|144601263|OTHER|||||||0.39||||||A p-value less than the a priori threshold of 0.05 is considered statistically significant.|t-test, 2 sided|||Analysis of difference in pain frequency.||||0.39
72535775|NCT05153629|144601263|OTHER|||||||0.26||||||A p-value less than the a priori threshold of 0.05 is considered statistically significant.|t-test, 2 sided|||Analysis of difference in nausea intensity.||||0.26
72535776|NCT05153629|144601264|OTHER|||||||0.5||||||A p-value less than the a priori threshold of 0.05 is considered statistically significant.|t-test, 2 sided|||||||0.50
72408559|NCT03228680|144325619|SUPERIORITY||Mean ratio|1.02||||0.814|TWO_SIDED|95.0|0.89|1.16||The P-value corresponds to the two-sided F-test of treatment effect.|ANCOVA|The ANCOVA model included treatment and AMH stratum (\<15 pmol/L and ≥15 pmol/L) as fixed factors and log-baseline as covariate.|Mean ratio is equal to FE 999049/FOLLISTIM.|Circulating levels of progesterone on stimulation Day 6.||1.16|0.89|0.814
72408560|NCT03228680|144325620|SUPERIORITY||Mean ratio|0.78|||<|0.001|TWO_SIDED|95.0|0.68|0.88||The P-value corresponds to the two-sided F-test of treatment effect.|ANCOVA|The ANCOVA model included treatment and AMH stratum (\<15 pmol/L and ≥15 pmol/L) as fixed factors and log-baseline as covariate.|Mean ratio is equal to FE 999049/FOLLISTIM.|Circulating levels of progesterone levels at end-of-stimulation.||0.88|0.68|<0.001
72408561|NCT03228680|144325621|SUPERIORITY||Mean ratio|0.82|||<|0.001|TWO_SIDED|95.0|0.73|0.92||The P-value corresponds to the two-sided F-test of treatment effect.|ANCOVA|The ANCOVA model included treatment and AMH stratum (\<15 pmol/L and ≥15 pmol/L) as fixed factors and log-baseline as covariate.|Mean ratio is equal to FE 999049/FOLLISTIM.|Circulating levels of Inhibin A on stimulation Day 6.||0.92|0.73|<0.001
72408562|NCT03228680|144325622|SUPERIORITY||Mean ratio|0.8|||<|0.001|TWO_SIDED|95.0|0.72|0.88||The P-value corresponds to the two-sided F-test of treatment effect.|ANCOVA|The ANCOVA model included treatment and AMH stratum (\<15 pmol/L and ≥15 pmol/L) as fixed factors and log-baseline as covariate.|Mean ratio is equal to FE 999049/FOLLISTIM.|Circulating levels of Inhibin A at end-of-stimulation.||0.88|0.72|<0.001
72408563|NCT03228680|144325623|SUPERIORITY||Mean ratio|0.83|||<|0.001|TWO_SIDED|95.0|0.75|0.93||The P-value corresponds to the two-sided F-test of treatment effect.|ANCOVA|The ANCOVA model included treatment and AMH stratum (\<15 pmol/L and ≥15 pmol/L) as fixed factors and log-baseline as covariate.|Mean ratio is equal to FE 999049/FOLLISTIM.|Circulating levels of Inhibin B on stimulation Day 6.||0.93|0.75|<0.001
72535777|NCT05153629|144601265|OTHER|||||||0.5||||||A p-value less than the a priori threshold of 0.05 is considered statistically significant.|t-test, 2 sided|||||||0.50
72408564|NCT03228680|144325624|SUPERIORITY||Mean ratio|0.88||||0.027|TWO_SIDED|95.0|0.79|0.99||The P-value corresponds to the two-sided F-test of treatment effect.|ANCOVA|The ANCOVA model included treatment and AMH stratum (\<15 pmol/L and ≥15 pmol/L) as fixed factors and log-baseline as covariate.|Mean ratio is equal to FE 999049/FOLLISTIM.|Circulating levels of Inhibin B at end-of-stimulation.||0.99|0.79|0.027
72535778|NCT05153629|144601266|OTHER|||||||0.8||||||A p-value less than the a priori threshold of 0.05 is considered statistically significant.|t-test, 2 sided|||Analysis of overall USDT score.||||0.80
72535779|NCT05153629|144601266|OTHER|||||||0.72||||||A p-value less than the a priori threshold of 0.05 is considered statistically significant.|t-test, 2 sided|||Analysis of urinary symptoms.||||0.72
72535780|NCT05153629|144601266|OTHER|||||||0.45||||||A p-value less than the a priori threshold of 0.05 is considered statistically significant.|t-test, 2 sided|||Analysis of pain.||||0.45
72535781|NCT05153629|144601266|OTHER|||||||0.42||||||A p-value less than the a priori threshold of 0.05 is considered statistically significant.|t-test, 2 sided|||Analysis of daily life.||||0.42
72408565|NCT03228680|144325625|SUPERIORITY|||||||0.694||||||2-sided|van Elteren test|P-value was based on van Elteren test adjusted for AMH strata.||The number of stimulation days at end-of-stimulation.||||0.694
72408566|NCT03022617|144325654|SUPERIORITY||Mean Difference (Final Values)|21.5|STANDARD_DEVIATION|10.89||0.05|TWO_SIDED||||||t-test, 2 sided|||||||.05
72408567|NCT00515827|144325674|SUPERIORITY_OR_OTHER_LEGACY|||||||0.546||95.0||||P-value is 2-sided and is not adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|||||||0.546
72408568|NCT01833403|144325683|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
72408569|NCT01032135|144325689|OTHER|||||||0.11|||||||Chi-squared|||||||0.11
72408570|NCT01032135|144325690|OTHER|||||||0.02|||||||Chi-squared|||||||0.02
72535782|NCT05153629|144601266|OTHER|||||||0.36||||||A p-value less than the a priori threshold of 0.05 is considered statistically significant.|t-test, 2 sided|||Analysis of sexual life.||||0.36
72535783|NCT05153629|144601266|OTHER|||||||0.49||||||A p-value less than the a priori threshold of 0.05 is considered statistically significant.|t-test, 2 sided|||Analysis of medical care/analgesic use.||||0.49
72535784|NCT05153629|144601266|OTHER|||||||0.88||||||A p-value less than the a priori threshold of 0.05 is considered statistically significant.|t-test, 2 sided|||Analysis of overall quality of life.||||0.88
72535785|NCT03743571|144601271|OTHER|We needed a total sample size of at least N = 24 to reach 80% power to detect a moderately large effect (Cohen's f = 0.3) for 2x2 interactions to determine whether scores differed across time (baseline vs follow up) for the two tDCS groups (anodal/active vs sham), and whether scores differed between audience type (matched vs unmatched) for the two tDCS groups (anodal/active vs sham).||||||0.42||||||Unadjusted. A priori threshold was set at p \< .05, two-tailed|ANOVA|tDCS (anodal vs sham) x Time (baseline vs follow-up) interaction: F(1,24) = 0.67, p = 0.42||We used a null hypothesis significance testing approach in our analyses. For performance on Behavioral Approach Tests (BATs), we completed 2 x 2 x 2 mixed factorial ANOVAs to evaluate the impact of tDCS groups (between-subjects variable; anodal/active vs sham), time (within subjects variable; baseline vs follow-up), and audience type (ethnicity primary matched vs unmatched to the participants' own identity) on outcome measures.||||.42
72573146|NCT03118570|144673094|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.544||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 6||||0.544
72573147|NCT03118570|144673094|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.615||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 6||||0.615
72408571|NCT01032135|144325691|OTHER|||||||0.005|||||||Chi-squared|||||||0.005
72408572|NCT01032135|144325696|OTHER||Odds Ratio (OR)|0.4||||0.0007|TWO_SIDED|95.0|0.23|0.68|||Chi-squared|||The statistical analyses used data from all follow up assessments.||0.68|0.23|0.0007
72408573|NCT01032135|144325696|OTHER||Odds Ratio (OR)|0.54||||0.16|TWO_SIDED|95.0|0.23|1.27|||Chi-squared|||The statistical analyses used data from all follow up assessments.||1.27|0.23|0.16
72408574|NCT01032135|144325696|OTHER||Odds Ratio (OR)|1.12||||0.79|TWO_SIDED|95.0|0.48|2.6|||Chi-squared|||The statistical analyses used data from all follow up assessments.||2.60|0.48|0.79
72535786|NCT03743571|144601272|OTHER|We needed a total sample size of at least N = 24 to reach 80% power to detect a moderately large effect (Cohen's f = 0.3) for 2x2 interactions to determine whether scores differed across time (baseline vs follow up) for the two tDCS groups (anodal/active vs sham), and whether scores differed between audience type (matched vs unmatched) for the two tDCS groups (anodal/active vs sham).||||||0.88||||||Unadjusted. A priori threshold was set at p \< .05, two-tailed|ANOVA|tDCS (anodal vs sham) x Time (baseline vs follow-up) interaction: F(1,24) = 0.02, p = .88.||We used a null hypothesis significance testing approach in our analyses. For performance on Behavioral Approach Tests (BATs), we completed 2 x 2 x 2 mixed factorial ANOVAs to evaluate the impact of tDCS groups (between-subjects variable; anodal/active vs sham), time (within subjects variable; baseline vs follow-up), and audience type (ethnicity primary matched vs unmatched to the participants' own identity) on outcome measures.||||.88
72535787|NCT03743571|144601273|OTHER|We needed a total sample size of at least N = 24 to reach 80% power to detect a moderately large effect (Cohen's f = 0.3) for 2x2 interactions to determine whether scores differed across time (baseline vs follow up) for the two tDCS groups (anodal/active vs sham), and whether scores differed between audience type (matched vs unmatched) for the two tDCS groups (anodal/active vs sham).||||||0.17||||||Unadjusted. A priori threshold was set at p \< .05, two-tailed|ANOVA|tDCS (anodal vs sham) x Time (baseline vs follow-up) interaction: F(1,24) = 1.98, p = .17||We used a null hypothesis significance testing approach in our analyses. For performance on Behavioral Approach Tests (BATs), we completed 2 x 2 x 2 mixed factorial ANOVAs to evaluate the impact of tDCS groups (between-subjects variable; anodal/active vs sham), time (within subjects variable; baseline vs follow-up), and audience type (ethnicity primary matched vs unmatched to the participants' own identity) on outcome measures.||||.17
72535788|NCT03743571|144601274|OTHER|We needed a total sample size of at least N = 24 to reach 80% power to detect a moderately large effect (Cohen's f = 0.3) for 2x2 interactions to determine whether scores differed across time (baseline vs follow up) for the two tDCS groups (anodal/active vs sham), and whether scores differed between audience type (matched vs unmatched) for the two tDCS groups (anodal/active vs sham).||||||0.42||||||Unadjusted. A priori threshold was set at p \< .05, two-tailed|ANOVA|tDCS (anodal vs sham) x Time (baseline vs follow-up) interaction: F(1,24) = 0.67, p = 0.42.||We used a null hypothesis significance testing approach in our analyses. For performance on Behavioral Approach Tests (BATs), we completed 2 x 2 x 2 mixed factorial ANOVAs to evaluate the impact of tDCS groups (between-subjects variable; anodal/active vs sham), time (within subjects variable; baseline vs follow-up), and audience type (ethnicity primary matched vs unmatched to the participants' own identity) on outcome measures.||||.42
72535789|NCT03743571|144601275|OTHER|We needed a total sample size of at least N = 24 to reach 80% power to detect a moderately large effect (Cohen's f = 0.3) for 2x2 interactions to determine whether scores differed across time (baseline vs follow up) for the two tDCS groups (anodal/active vs sham), and whether scores differed between audience type (matched vs unmatched) for the two tDCS groups (anodal/active vs sham).||||||0.88||||||Unadjusted. A priori threshold was set at p \< .05, two-tailed|ANOVA|tDCS (anodal vs sham) x Time (baseline vs follow-up) interaction: F(1,24) = 0.02, p = .88.||We used a null hypothesis significance testing approach in our analyses. For performance on Behavioral Approach Tests (BATs), we completed 2 x 2 x 2 mixed factorial ANOVAs to evaluate the impact of tDCS groups (between-subjects variable; anodal/active vs sham), time (within subjects variable; baseline vs follow-up), and audience type (ethnicity primary matched vs unmatched to the participants' own identity) on outcome measures.||||.88
72535790|NCT03743571|144601276|OTHER|We needed a total sample size of at least N = 24 to reach 80% power to detect a moderately large effect (Cohen's f = 0.3) for 2x2 interactions to determine whether scores differed across time (baseline vs follow up) for the two tDCS groups (anodal/active vs sham), and whether scores differed between audience type (matched vs unmatched) for the two tDCS groups (anodal/active vs sham).||||||0.17||||||Unadjusted. A priori threshold was set at p \< .05, two-tailed|ANOVA|tDCS (anodal vs sham) x Time (baseline vs follow-up) interaction: F(1,24) = 1.98, p = .17.||We used a null hypothesis significance testing approach in our analyses. For performance on Behavioral Approach Tests (BATs), we completed 2 x 2 x 2 mixed factorial ANOVAs to evaluate the impact of tDCS groups (between-subjects variable; anodal/active vs sham), time (within subjects variable; baseline vs follow-up), and audience type (ethnicity primary matched vs unmatched to the participants' own identity) on outcome measures.||||.17
72535791|NCT03743571|144601277|OTHER|We needed a total sample size of at least N = 24 to reach 80% power to detect a moderately large effect (Cohen's f = 0.3) for 2x2 interactions to determine whether scores differed across time (baseline vs follow up) for the two tDCS groups (anodal/active vs sham).||||||0.67||||||Unadjusted. A priori threshold was set at p \< .05, two-tailed|ANOVA|tDCS (anodal vs sham) x Time (baseline vs follow-up) interaction: F(1,26) = 0.19, p = .67||We used a null hypothesis significance testing approach in our analyses. For performance on the questionnaires, we completed 2 x 2 mixed factorial ANOVAs to evaluate the impact of tDCS groups (between-subjects variable; anodal/active vs sham) and time (within subjects variable; baseline vs follow-up) on outcome measures.||||.67
72573148|NCT03118570|144673094|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.179||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 12||||0.179
72573149|NCT03118570|144673094|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.513||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 12||||0.513
72573150|NCT03118570|144673094|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.849||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 12||||0.849
72628219|NCT00492557|144784517|NON_INFERIORITY_OR_EQUIVALENCE|The criterion upon which to declare non-inferiority was if the lower limit of the 2-sided 95%CI for the GMT ratios, (13vPnC+TIV relative to 13vPnC administered 1 month after TIV+placebo) was greater than 0.5 (2-fold criterion).|GMT Ratio|0.8|||||TWO_SIDED|95.0|0.54|1.08|||||2-sided 95% CIs for the GMT ratio were calculated by back transformations of the 95% CIs based on the Student t distribution for the mean difference of the logarithmically transformed assay results.|Serotype 6A. The primary null hypothesis was: the log of the GMT in the group receiving 13vPnC + TIV minus the log of the GMT in the group receiving 13vPnC alone (1 month after TIV) \<= -0.693.||1.08|0.54|
72408575|NCT01032135|144325701|OTHER||Odds Ratio (OR)|-1.08||||0.009|TWO_SIDED|95.0|-1.87|-0.29|||Chi-squared|||The statistical analyses used data from all follow up assessments.||-0.29|-1.87|0.009
72535792|NCT03743571|144601278|OTHER|We needed a total sample size of at least N = 24 to reach 80% power to detect a moderately large effect (Cohen's f = 0.3) for 2x2 interactions to determine whether scores differed across time (baseline vs follow up) for the two tDCS groups (anodal/active vs sham).||||||0.96||||||Unadjusted. A priori threshold was set at p \< .05, two-tailed|ANOVA|tDCS (anodal vs sham) x Time (baseline vs follow-up) interaction: F(1,26) \< .01, p = .96||We used a null hypothesis significance testing approach in our analyses. For performance on the questionnaires, we completed 2 x 2 mixed factorial ANOVAs to evaluate the impact of tDCS groups (between-subjects variable; anodal/active vs sham) and time (within subjects variable; baseline vs follow-up) on outcome measures.||||.96
72535793|NCT03743571|144601279|OTHER|We needed a total sample size of at least N = 24 to reach 80% power to detect a moderately large effect (Cohen's f = 0.3) for 2x2 interactions to determine whether scores differed across time (baseline vs follow up) for the two tDCS groups (anodal/active vs sham),||||||0.43||||||Unadjusted. A priori threshold was set at p \< .05, two-tailed|ANOVA|tDCS (anodal vs sham) x Time (baseline vs follow-up) interaction: F(1,26) = 0.65, p = .43||We used a null hypothesis significance testing approach in our analyses. For performance on the questionnaires, we completed 2 x 2 mixed factorial ANOVAs to evaluate the impact of tDCS groups (between-subjects variable; anodal/active vs sham) and time (within subjects variable; baseline vs follow-up) on outcome measures.||||.43
72535794|NCT04115488|144601280|EQUIVALENCE|Data was analyzed using a negative binomial model with a logarithmic link function and fixed effects for the treatment group and stratification factors. Equivalence was tested based 95% confidence interval.|Exponentiated Difference|0.17|STANDARD_ERROR_OF_MEAN|0.397|||TWO_SIDED|95.0|-0.613|0.944|||||Difference calculated as Tysabri minus PB006.|||0.944|-0.613|
72535795|NCT03315780|144601353|SUPERIORITY||Mean Difference (Final Values)|-254.02|||<|0.0001|TWO_SIDED|95.0|-337.76|-170.28|||Mixed Models Analysis|||||-170.28|-337.76|< 0.0001
72535796|NCT03315780|144601356|SUPERIORITY||Mean Difference (Final Values)|27.46||||0.01|TWO_SIDED|95.0|8.05|46.87|||Mixed Models Analysis|||||46.87|8.05|0.0100
72535797|NCT03315780|144601357|SUPERIORITY||Mean Difference (Final Values)|3.72||||0.0263|TWO_SIDED|95.0|0.63|6.81|||Mixed Models Analysis|||||6.81|0.63|0.0263
72535798|NCT03315780|144601358|SUPERIORITY||Mean Difference (Final Values)|-9.36||||0.08|TWO_SIDED|95.0|-20.16|1.43|||Mixed Models Analysis|||||1.43|-20.16|0.0800
72535799|NCT03315780|144601359|SUPERIORITY||Mean Difference (Final Values)|-15.39||||0.7475|TWO_SIDED|95.0|-118.35|87.57|||Mixed Models Analysis|||||87.57|-118.35|0.7475
72535800|NCT01361308|144601361|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Week 4 frequency|Rank transformed ANCOVA|||||||<0.0001
72535801|NCT01361308|144601361|SUPERIORITY_OR_OTHER|||||||0.009||||||Week 12 frequency|Rank transformed ANCOVA|||||||0.0090
72535802|NCT01361308|144601362|SUPERIORITY_OR_OTHER|||||||0.001||||||Clinical meaningfulness at week 4|Logit model|||||||0.001
72535803|NCT01361308|144601362|SUPERIORITY_OR_OTHER|||||||0.055||||||Clinical meaningfulness at week 12|Logit model|||||||0.055
72535804|NCT01361308|144601378|SUPERIORITY_OR_OTHER|||||||0.0017||||||Week 4 severity|Rank transformed ANCOVA|||||||0.0017
72535805|NCT01361308|144601378|SUPERIORITY_OR_OTHER|||||||0.1658||||||Week 12 severity|Rank transformed ANCOVA|||||||0.1658
72535806|NCT03433482|144601394|NON_INFERIORITY|Non-inferiority is concluded if the lower limit of the two sided 95% confidence interval (CI) for the hSBA GMT ratio for serogroup A between the MenACWY liquid vaccine aged for approximately 24 months and the licensed MenACWY vaccine is \> 0.5.|GMT ratio|1.21|||||TWO_SIDED|95.0|0.94|1.57|||ANCOVA|Analysis of Covariance (ANCOVA) including pre-vaccination titer (Day 1) as a covariate and with vaccine group and country as factors.||To demonstrate non-inferiority of the MenACWY liquid vaccine aged for approximately 24 months to that of currently licensed MenACWY vaccine, as measured by the adjusted hSBA GMTs directed against N. meningitidis serogroup A at Day 29 after a single dose vaccination||1.57|0.94|
72535807|NCT03433482|144601394|NON_INFERIORITY|Non-inferiority is concluded if the lower limit of the two sided 95% CI for the hSBA GMT ratios for serogroup A between the MenACWY liquid vaccine aged for approximately 30 months and the licensed MenACWY vaccine is \> 0.5. Non-inferiority hypotheses testing will be conducted sequentially, starting from MenACWY liquid vaccine aged for approximately 24 months and subsequently with MenACWY liquid vaccine aged for approximately 30 months.|GMT ratio|1.11|||||TWO_SIDED|95.0|0.87|1.42|||ANCOVA|Analysis of Covariance (ANCOVA) including pre-vaccination titer (Day 1) as a covariate and with vaccine group and country as factors.||To demonstrate non-inferiority of the MenACWY liquid vaccine aged for approximately 30 months to that of currently licensed MenACWY vaccine, as measured by the adjusted hSBA GMTs directed against N. meningitidis serogroup A at Day 29 after a single dose vaccination.||1.42|0.87|
72535808|NCT03433482|144601395|OTHER||GMT ratio|0.84|||||TWO_SIDED|95.0|0.58|1.19|||ANCOVA|Analysis of Covariance (ANCOVA) including pre-vaccination titer (Day 1) as a covariate and with vaccine group and center (if applicable) as factors.||Between-groups ratio of adjusted hSBA GMTs and its 95% CI, between vaccine groups GSK3536820A ACWY\_Liq24 and ACWY\_1, at Day 29 against serogroup C||1.19|0.58|
72535809|NCT03433482|144601395|OTHER||GMT ratio|0.94|||||TWO_SIDED|95.0|0.72|1.24|||ANCOVA|Analysis of Covariance (ANCOVA) including pre-vaccination titer (Day 1) as a covariate and with vaccine group and center (if applicable) as factors.||Between-groups ratio of adjusted hSBA GMTs and its 95% CI, between vaccine groups GSK3536820A ACWY\_Liq24 and ACWY\_1, at Day 29 against serogroup W||1.24|0.72|
72535810|NCT03433482|144601395|OTHER||GMT ratio|1.09|||||TWO_SIDED|95.0|0.82|1.44|||ANCOVA|Analysis of Covariance (ANCOVA) including pre-vaccination titer (Day 1) as a covariate and with vaccine group and center (if applicable) as factors.||Between-groups ratio of adjusted hSBA GMTs and its 95% CI, between vaccine groups GSK3536820A ACWY\_Liq24 and ACWY\_1, at Day 29 against serogroup Y||1.44|0.82|
72573151|NCT03118570|144673094|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.037||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 18||||0.037
72573152|NCT03118570|144673094|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.88||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 18||||0.880
72573153|NCT03118570|144673094|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.153||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 18||||0.153
72573154|NCT03118570|144673094|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.073||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 24||||0.073
72573155|NCT03118570|144673094|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.007||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 24||||0.007
72573156|NCT03118570|144673094|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.791||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 24||||0.791
72573157|NCT03118570|144673094|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.01||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 6||||0.010
72573158|NCT03118570|144673094|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.553||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 6||||0.553
72573159|NCT03118570|144673094|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.652||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 6||||0.652
72573160|NCT03118570|144673094|SUPERIORITY|Comparison is between the Visit and Baseline|||||<|0.001||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 12||||< 0.001
72408576|NCT01032135|144325701|OTHER||Odds Ratio (OR)|-0.84||||0.23|TWO_SIDED|95.0|-2.2|0.52|||Chi-squared|||The statistical analyses used data from all follow up assessments.||0.52|-2.20|0.23
72573161|NCT03118570|144673094|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.482||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 12||||0.482
72573162|NCT03118570|144673094|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.685||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 12||||0.685
72573163|NCT03118570|144673094|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.002||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 18||||0.002
72573164|NCT03118570|144673094|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.672||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 18||||0.672
72573165|NCT03118570|144673094|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.377||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 18||||0.377
72573166|NCT03118570|144673094|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.015||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 24||||0.015
72573167|NCT03118570|144673094|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.086||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 24||||0.086
72573168|NCT03118570|144673094|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.712||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 24||||0.712
72573169|NCT03118570|144673096|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.045||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Lean, Month 6||||0.045
72573170|NCT03118570|144673096|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.101||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Lean, Month 6||||0.101
72573171|NCT03118570|144673096|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.482||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Lean, Month 6||||0.482
72573172|NCT03118570|144673096|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.011||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Lean, Month 12||||0.011
72573173|NCT03118570|144673096|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.508||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Lean, Month 12||||0.508
72573174|NCT03118570|144673096|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.563||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Lean, Month 12||||0.563
72573175|NCT03118570|144673096|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.917||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Fat, Month 6||||0.917
72573176|NCT03118570|144673096|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.789||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Fat, Month 6||||0.789
72573177|NCT03118570|144673096|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.262||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Fat, Month 6||||0.262
72408577|NCT01032135|144325701|OTHER||Odds Ratio (OR)|-0.34||||0.58|TWO_SIDED|95.0|-1.52|0.85|||Chi-squared|||The statistical analyses used data from all follow up assessments.||0.85|-1.52|0.58
72573178|NCT03118570|144673096|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.426||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Fat, Month 12||||0.426
72408578|NCT01032135|144325706|OTHER||Odds Ratio (OR)|0.33||||0.0001|TWO_SIDED|95.0|0.19|0.58|||Chi-squared|||The statistical analyses used data from all follow up assessments.||0.58|0.19|0.0001
72408579|NCT01032135|144325706|OTHER||Odds Ratio (OR)|0.67||||0.36|TWO_SIDED|95.0|0.29|1.54|||Chi-squared|||The statistical analyses used data from all follow up assessments.||1.54|0.29|0.36
72408580|NCT01032135|144325706|OTHER||Odds Ratio (OR)|1.43||||0.45|TWO_SIDED|95.0|0.58|3.54|||Chi-squared|||The statistical analyses used data from all follow up assessments.||3.54|0.58|0.45
72573179|NCT03118570|144673096|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.871||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Fat, Month 12||||0.871
72573180|NCT03118570|144673096|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.113||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Fat, Month 12||||0.113
72573181|NCT03118570|144673097|SUPERIORITY|Comparison is between the Visit and Baseline|||||<|0.001||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 1||||< 0.001
72573182|NCT03118570|144673097|SUPERIORITY|Comparison is between the Visit and Baseline|||||<|0.001||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 1||||< 0.001
72573183|NCT03118570|144673097|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.984||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 1||||0.984
72573184|NCT03118570|144673097|SUPERIORITY|Comparison is between the Visit and Baseline|||||<|0.001||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 3||||< 0.001
72573185|NCT03118570|144673097|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.05||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 3||||0.050
72573186|NCT03118570|144673097|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.857||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 3||||0.857
72573187|NCT03118570|144673097|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.001||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 6||||0.001
72573188|NCT03118570|144673097|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.079||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 6||||0.079
72535811|NCT03433482|144601395|OTHER||GMT ratio|1.14|||||TWO_SIDED|95.0|0.79|1.64|||ANCOVA|Analysis of Covariance (ANCOVA) including pre-vaccination titer (Day 1) as a covariate and with vaccine group and center (if applicable) as factors.||Between-groups ratio of adjusted hSBA GMTs and its 95% CI, between vaccine groups GSK3536820A ACWY\_Liq30 and ACWY\_2, at Day 29 against serogroup C||1.64|0.79|
72535812|NCT03433482|144601395|OTHER||GMT ratio|1.1|||||TWO_SIDED|95.0|0.84|1.45|||ANCOVA|Analysis of Covariance (ANCOVA) including pre-vaccination titer (Day 1) as a covariate and with vaccine group and center (if applicable) as factors.||Between-groups ratio of adjusted hSBA GMTs and its 95% CI, between vaccine groups GSK3536820A ACWY\_Liq30 and ACWY\_2, at Day 29 against serogroup W||1.45|0.84|
72535813|NCT03433482|144601395|OTHER||GMT ratio|0.96|||||TWO_SIDED|95.0|0.72|1.26|||ANCOVA|Analysis of Covariance (ANCOVA) including pre-vaccination titer (Day 1) as a covariate and with vaccine group and center (if applicable) as factors.||Between-groups ratio of adjusted hSBA GMTs and its 95% CI, between vaccine groups GSK3536820A ACWY\_Liq30 and ACWY\_2, at Day 29 against serogroup Y||1.26|0.72|
72535814|NCT03433482|144601397|OTHER||Difference in percentage of subjects|2.21|||||TWO_SIDED|95.0|-1.94|6.4|||Miettinen and Nurminen score method|||Between-group difference in percentage of subjects with a ≥ 4-fold rise in post-vaccination hSBA for N. meningitidis serogroup A at Day 29.||6.40|-1.94|
72535815|NCT03433482|144601397|OTHER||Difference in percentage of subjects|-2.12|||||TWO_SIDED|95.0|-8.94|4.72|||Miettinen and Nurminen score method|||Between-group difference in percentage of subjects with a ≥ 4-fold rise in post-vaccination hSBA for N. meningitidis serogroup C at Day 29.||4.72|-8.94|
72535816|NCT03433482|144601397|OTHER||Difference in percentage of subjects|-1.16|||||TWO_SIDED|95.0|-8.11|5.8|||Miettinen and Nurminen score method|||Between-group difference in percentage of subjects with a ≥ 4-fold rise in post-vaccination hSBA for N. meningitidis serogroup W at Day 29.||5.80|-8.11|
72535817|NCT03433482|144601397|OTHER||Difference in percentage of subjects|-1.57|||||TWO_SIDED|95.0|-7.88|4.74|||Miettinen and Nurminen score method|||Between-group difference in percentage of subjects with a ≥ 4-fold rise in post-vaccination hSBA for N. meningitidis serogroup Y at Day 29.||4.74|-7.88|
72535818|NCT03433482|144601397|OTHER||Difference in percentage of subjects|-0.12|||||TWO_SIDED|95.0|-4.29|4.07|||Miettinen and Nurminen score method|||Between-group difference in percentage of subjects with a ≥ 4-fold rise in post-vaccination hSBA for N. meningitidis serogroup A at Day 29.||4.07|-4.29|
72535819|NCT03433482|144601397|OTHER||Difference in percentage of subjects|2.85|||||TWO_SIDED|95.0|-3.63|9.3|||Miettinen and Nurminen score method|||Between-group difference in percentage of subjects with a ≥ 4-fold rise in post-vaccination hSBA for N. meningitidis serogroup C at Day 29.||9.30|-3.63|
72535820|NCT03433482|144601397|OTHER||Difference in percentage of subjects|4.01|||||TWO_SIDED|95.0|-2.89|10.88|||Miettinen and Nurminen score method|||Between-group difference in percentage of subjects with a ≥ 4-fold rise in post-vaccination hSBA for N. meningitidis serogroup W at Day 29.||10.88|-2.89|
72535821|NCT03433482|144601397|OTHER||Difference in percentage of subjects|-2.84|||||TWO_SIDED|95.0|-8.91|3.26|||Miettinen and Nurminen score method|||Between-group difference in percentage of subjects with a ≥ 4-fold rise in post-vaccination hSBA for N. meningitidis serogroup Y at Day 29.||3.26|-8.91|
72628220|NCT00492557|144784517|NON_INFERIORITY_OR_EQUIVALENCE|The criterion upon which to declare non-inferiority was if the lower limit of the 2-sided 95%CI for the GMT ratios, (13vPnC+TIV relative to 13vPnC administered 1 month after TIV+placebo) was greater than 0.5 (2-fold criterion).|GMT Ratio|0.8|||||TWO_SIDED|95.0|0.55|1.09|||||2-sided 95% CIs for the GMT ratio were calculated by back transformations of the 95% CIs based on the Student t distribution for the mean difference of the logarithmically transformed assay results.|Serotype 6B. The primary null hypothesis was: the log of the GMT in the group receiving 13vPnC + TIV minus the log of the GMT in the group receiving 13vPnC alone (1 month after TIV) \<= -0.693.||1.09|0.55|
72535822|NCT03433482|144601398|OTHER||Difference in percentage of subjects|1.79|||||TWO_SIDED|95.0|-2.69|6.32|||Miettinen and Nurminen score method|||Between-group difference in percentages of subjects with hSBA titer ≥8 for the N. meningitidis serogroup A on Day 1.||6.32|-2.69|
72535823|NCT03433482|144601398|OTHER||Difference in percentage of subjects|6.96|||||TWO_SIDED|95.0|0.01|13.84|||Miettinen and Nurminen score method|||Between-group difference in percentages of subjects with hSBA titer ≥8 for the N. meningitidis serogroup C on Day 1.||13.84|0.01|
72535824|NCT03433482|144601398|OTHER||Difference in percentage of subjects|3.13|||||TWO_SIDED|95.0|-3.33|9.58|||Miettinen and Nurminen score method|||Between-group difference in percentages of subjects with hSBA titer ≥8 for the N. meningitidis serogroup W on Day 1.||9.58|-3.33|
72535825|NCT03433482|144601398|OTHER||Difference in percentage of subjects|0.96|||||TWO_SIDED|95.0|-4.86|6.8|||Miettinen and Nurminen score method|||Between-group difference in percentages of subjects with hSBA titer ≥8 for the N. meningitidis serogroup Y on Day 1.||6.80|-4.86|
72535826|NCT03433482|144601398|OTHER||Difference in percentage of subjects|1.46|||||TWO_SIDED|95.0|-2.24|5.22|||Miettinen and Nurminen score method|||Between-group difference in percentages of subjects with hSBA titer ≥8 for the N. meningitidis serogroup A on Day 29.||5.22|-2.24|
72535827|NCT03433482|144601398|OTHER||Difference in percentage of subjects|-0.43|||||TWO_SIDED|95.0|-6.32|5.46|||Miettinen and Nurminen score method|||Between-group difference in percentages of subjects with hSBA titer ≥8 for the N. meningitidis serogroup C on Day 29.||5.46|-6.32|
72535828|NCT03433482|144601398|OTHER||Difference in percentage of subjects|-1.43|||||TWO_SIDED|95.0|-7.05|4.18|||Miettinen and Nurminen score method|||Between-group difference in percentages of subjects with hSBA titer ≥8 for the N. meningitidis serogroup W on Day 29.||4.18|-7.05|
72535829|NCT03433482|144601398|OTHER||Difference in percentage of subjects|2.04|||||TWO_SIDED|95.0|-2.81|6.9|||Miettinen and Nurminen score method|||Between-group difference in percentages of subjects with hSBA titer ≥8 for the N. meningitidis serogroup Y on Day 29.||6.90|-2.81|
72535830|NCT03433482|144601398|OTHER||Difference in percentage of subjects|1.5|||||TWO_SIDED|95.0|-3.32|6.33|||Miettinen and Nurminen score method|||Between-group difference in percentages of subjects with hSBA titer ≥8 for the N. meningitidis serogroup A on Day 1.||6.33|-3.32|
72535831|NCT03433482|144601398|OTHER||Difference in percentage of subjects|0.38|||||TWO_SIDED|95.0|-6.6|7.35|||Miettinen and Nurminen score method|||Between-group difference in percentages of subjects with hSBA titer ≥8 for the N. meningitidis serogroup C on Day 1.||7.35|-6.60|
72408581|NCT01032135|144325711|OTHER||Odds Ratio (OR)|-1.09||||0.003|TWO_SIDED|95.0|-1.8|-0.39|||Chi-squared|||The statistical analyses used data from all follow up assessments.||-0.39|-1.80|0.003
72408582|NCT01032135|144325711|OTHER||Odds Ratio (OR)|0.02||||0.1|TWO_SIDED|95.0|-1.1|1.14|||Chi-squared|||The statistical analyses used data from all follow up assessments.||1.14|-1.10|0.10
72408583|NCT01032135|144325715|OTHER||Odds Ratio (OR)|0.66||||0.13|TWO_SIDED|95.0|0.38|1.14|||Chi-squared|||The statistical analyses used data from all follow up assessments.||1.14|0.38|0.13
72408584|NCT01032135|144325715|OTHER||Odds Ratio (OR)|0.83||||0.71|TWO_SIDED|95.0|0.33|2.12|||Chi-squared|||The statistical analyses used data from all follow up assessments.||2.12|0.33|0.71
72408585|NCT01032135|144325715|OTHER||Odds Ratio (OR)|1.48||||0.36|TWO_SIDED|95.0|0.64|3.4|||Chi-squared|||The statistical analyses used data from all follow up assessments.||3.40|0.64|0.36
72408586|NCT01032135|144325718|OTHER||Odds Ratio (OR)|-0.13||||0.75|TWO_SIDED|95.0|-0.94|0.6|||Chi-squared|||The statistical analyses used data from all follow up assessments.||0.60|-0.94|0.75
72408587|NCT01032135|144325718|OTHER||Odds Ratio (OR)|-0.84||||0.16|TWO_SIDED|95.0|-1.98|0.3|||Chi-squared|||The statistical analyses used data from all follow up assessments.||0.30|-1.98|0.16
72408588|NCT01032135|144325718|OTHER||Odds Ratio (OR)|0.6||||0.42|TWO_SIDED|95.0|-0.85|2.04|||Chi-squared|||The statistical analyses used data from all follow up assessments.||2.04|-0.85|0.42
72408589|NCT02553746|144325725|SUPERIORITY|||||||0.748|||||||Chi-squared, Corrected|||||||0.748
72408590|NCT02553746|144325726|SUPERIORITY|||||||0.498|||||||Chi-squared, Corrected|||||||0.498
72535832|NCT03433482|144601398|OTHER||Difference in percentage of subjects|-1.26|||||TWO_SIDED|95.0|-7.75|5.23|||Miettinen and Nurminen score method|||Between-group difference in percentages of subjects with hSBA titer ≥8 for the N. meningitidis serogroup W on Day 1.||5.23|-7.75|
72408591|NCT02553746|144325727|SUPERIORITY|||||||0.171|||||||Wilcoxon (Mann-Whitney)|||||||0.171
72408592|NCT02553746|144325728|SUPERIORITY|||||||0.162|||||||Wilcoxon (Mann-Whitney)|||||||0.162
72408593|NCT02553746|144325729|SUPERIORITY|||||||0.104|||||||Chi-squared, Corrected|||||||0.104
72408594|NCT02553746|144325730|SUPERIORITY||||||<|0.005|||||||Wilcoxon (Mann-Whitney)|||||||<0.005
72408595|NCT01227512|144325737|SUPERIORITY_OR_OTHER|||||||0.9495||||||The alpha level was set at 0.05|Generalized Wilcoxon Test|Participants who used rescue therapy within first 7 days of treatment period were censored at time they started the rescue therapy.||||||0.9495
72535833|NCT03433482|144601398|OTHER||Difference in percentage of subjects|-0.85|||||TWO_SIDED|95.0|-6.69|4.98|||Miettinen and Nurminen score method|||Between-group difference in percentages of subjects with hSBA titer ≥8 for the N. meningitidis serogroup Y on Day 1.||4.98|-6.69|
72535834|NCT03433482|144601398|OTHER||Difference in percentage of subjects|-0.64|||||TWO_SIDED|95.0|-4.24|2.96|||Miettinen and Nurminen score method|||Between-group difference in percentages of subjects with hSBA titer ≥8 for the N. meningitidis serogroup A on Day 29.||2.96|-4.24|
72535835|NCT03433482|144601398|OTHER||Difference in percentage of subjects|1.32|||||TWO_SIDED|95.0|-3.99|6.64|||Miettinen and Nurminen score method|||Between-group difference in percentages of subjects with hSBA titer ≥8 for the N. meningitidis serogroup C on Day 29.||6.64|-3.99|
72535836|NCT03433482|144601398|OTHER||Difference in percentage of subjects|4.09|||||TWO_SIDED|95.0|-1.11|9.33|||Miettinen and Nurminen score method|||Between-group difference in percentages of subjects with hSBA titer ≥8 the N. meningitidis serogroup W on Day 29.||9.33|-1.11|
72535837|NCT03433482|144601398|OTHER||Difference in percentage of subjects|0.48|||||TWO_SIDED|95.0|-4.16|5.13|||Miettinen and Nurminen score method|||Between-group difference in percentages of subjects with hSBA titer ≥8 for the N. meningitidis serogroup Y on Day 29.||5.13|-4.16|
72535838|NCT03433482|144601399|OTHER||Difference in percentage of subjects|1.29|||||TWO_SIDED|95.0|-3.37|5.99|||Miettinen and Nurminen score method|||Between-group difference in percentages of subjects with hSBA titer ≥LLOQ for the N. meningitidis serogroup A at Day 1||5.99|-3.37|
72535839|NCT03433482|144601399|OTHER||Difference in percentage of subjects|7.23|||||TWO_SIDED|95.0|0.25|14.13|||Miettinen and Nurminen score method|||Between-group difference in percentages of subjects with hSBA titer ≥LLOQ for the N. meningitidis serogroup C at Day 1||14.13|0.25|
72535840|NCT03433482|144601399|OTHER||Difference in percentage of subjects|3.92|||||TWO_SIDED|95.0|-2.57|10.39|||Miettinen and Nurminen score method|||Between-group difference in percentages of subjects with hSBA titer ≥LLOQ for the N. meningitidis serogroup W at Day 1||10.39|-2.57|
72408596|NCT01227512|144325738|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3||||0.146||95.0|-0.7|0.11||alpha level was set at 0.05. p-value was derived from an ANCOVA model with treatment and clinical center as factors and baseline value as covariate.|ANCOVA|Includes factors of treatment, study center and covariate baseline.||||0.11|-0.70|0.1460
72408597|NCT01227512|144325739|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.19||||0.315||95.0|-0.57|0.19|||ANCOVA|P-value was derived from an ANCOVA model with treatment and clinical center as factors and baseline value as covariate.||P value corresponds to 24 hours post-dose.||0.19|-0.57|0.3150
72408598|NCT01227512|144325739|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.13||||0.5381||95.0|-0.57|0.3|||ANCOVA|P-value was derived from an ANCOVA model with treatment and clinical center as factors and baseline value as covariate.||P value corresponds to 72 hours post-dose.||0.30|-0.57|0.5381
72408599|NCT01227512|144325740|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.26||||0.2702||95.0|-0.73|0.21||P-value was derived from a Cochran-Mantel-Haenszel (CMH) row mean scores test.|Cochran-Mantel-Haenszel|||||0.21|-0.73|0.2702
72408600|NCT01227512|144325741|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.77||||0.0019||95.0|1.43|6.11||P-value was derived from an ANCOVA model with treatment and clinical center as factors and baseline value as covariate.|ANCOVA|||||6.11|1.43|0.0019
72408601|NCT01227512|144325742|SUPERIORITY_OR_OTHER|||||||0.5128||||||p-value was derived from Generalized Wilcoxon test stratified by treatment. Participants who received rescue therapy were censored at the time of receiving rescue therapy.|Generalized Wilcoxon Test|||||||0.5128
72408602|NCT01227512|144325743|SUPERIORITY_OR_OTHER||Relative Risk|1.1||||0.5795||95.0|0.79|1.52||P-value was derived using a CMH test stratified by hyponatremia symptoms severity.|Cochran-Mantel-Haenszel|||||1.52|0.79|0.5795
72408603|NCT01227512|144325744|SUPERIORITY_OR_OTHER||Relative Risk|0.33||||0.1568||95.0|0.07|1.65||p-value was derived using a CMH test stratified by hyponatremia symptoms severity.|Cochran-Mantel-Haenszel|||||1.65|0.07|0.1568
72573189|NCT03118570|144673097|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.912||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 6||||0.912
72573190|NCT03118570|144673097|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.054||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 9||||0.054
72573191|NCT03118570|144673097|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.95||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 9||||0.950
72573192|NCT03118570|144673097|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.555||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 9||||0.555
72573193|NCT03118570|144673097|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.221||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 12||||0.221
72573194|NCT03118570|144673097|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.393||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 12||||0.393
72573195|NCT03118570|144673097|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.385||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 12||||0.385
72573196|NCT03118570|144673098|SUPERIORITY|Comparison is between the Visit and Baseline|||||<|0.001||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 1||||< 0.001
72573197|NCT03118570|144673098|SUPERIORITY|Comparison is between the Visit and Baseline|||||<|0.001||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 1||||< 0.001
72573198|NCT03118570|144673098|SUPERIORITY|Comparison is between the Visit and Baseline|||||<|0.001||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 1||||< 0.001
72573199|NCT03118570|144673098|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.003||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 3||||0.003
72573200|NCT03118570|144673098|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.05||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 3||||0.050
72573201|NCT03118570|144673098|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.006||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 3||||0.006
72573202|NCT03118570|144673098|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.519||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 6||||0.519
72573203|NCT03118570|144673098|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.226||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 6||||0.226
72573204|NCT03118570|144673098|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.19||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 6||||0.190
72573205|NCT03118570|144673098|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.388||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 9||||0.388
72573206|NCT03118570|144673098|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.109||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 9||||0.109
72573207|NCT03118570|144673098|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.204||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 9||||0.204
72573208|NCT03118570|144673098|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.119||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 12||||0.119
72573209|NCT03118570|144673098|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.925||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 12||||0.925
72408604|NCT04035486|144325805|SUPERIORITY||Hazard Ratio (HR)|0.62|||<|0.0001|TWO_SIDED|95.0|0.49|0.79|||Log Rank||A hazard ratio of less than 1 favors the Osimertinib (AZD9291) + Chemo treatment arm.|The analysis was performed using a log rank test stratified by race (Chinese/Asian vs. Non-Chinese/Asian vs. Non-Asian), WHO performance status (0 vs. 1), and method used for tissue testing (central vs. local).||0.79|0.49|<0.0001
72535841|NCT03433482|144601399|OTHER||Difference in percentage of subjects|1.49|||||TWO_SIDED|95.0|-4.44|7.44|||Miettinen and Nurminen score method|||Between-group difference in percentages of subjects with hSBA titer ≥LLOQ for the N. meningitidis serogroup Y at Day 1||7.44|-4.44|
72535842|NCT03433482|144601399|OTHER||Difference in percentage of subjects|1.73|||||TWO_SIDED|95.0|-1.94|5.46|||Miettinen and Nurminen score method|||Between-group difference in percentages of subjects with hSBA titer ≥LLOQ for the N. meningitidis serogroup A at Day 29||5.46|-1.94|
72535843|NCT03433482|144601399|OTHER||Difference in percentage of subjects|-0.99|||||TWO_SIDED|95.0|-6.66|4.7|||Miettinen and Nurminen score method|||Between-group difference in percentages of subjects with hSBA titer ≥LLOQ for the N. meningitidis serogroup C at Day 29||4.70|-6.66|
72535844|NCT03433482|144601399|OTHER||Difference in percentage of subjects|-1.43|||||TWO_SIDED|95.0|-7.05|4.18|||Miettinen and Nurminen score method|||Between-group difference in percentages of subjects with hSBA titer ≥LLOQ for the N. meningitidis serogroup W at Day 29||4.18|-7.05|
72535845|NCT03433482|144601399|OTHER||Difference in percentage of subjects|2.06|||||TWO_SIDED|95.0|-2.67|6.8|||Miettinen and Nurminen score method|||Between-group difference in percentages of subjects with hSBA titer ≥LLOQ for the N. meningitidis serogroup Y at Day 29||6.80|-2.67|
72535846|NCT03433482|144601399|OTHER||Difference in percentage of subjects|1.75|||||TWO_SIDED|95.0|-3.32|6.83|||Miettinen and Nurminen score method|||Between-group difference in percentages of subjects with hSBA titer ≥LLOQ for the N. meningitidis serogroup A at Day 1||6.83|-3.32|
72535847|NCT03433482|144601399|OTHER||Difference in percentage of subjects|3.87|||||TWO_SIDED|95.0|-3.0|10.71|||Miettinen and Nurminen score method|||Between-group difference in percentages of subjects with hSBA titer ≥LLOQ for the N. meningitidis serogroup C at Day 1||10.71|-3.00|
72535848|NCT03433482|144601399|OTHER||Difference in percentage of subjects|-0.73|||||TWO_SIDED|95.0|-7.24|5.77|||Miettinen and Nurminen score method|||Between-group difference in percentages of subjects with hSBA titer ≥LLOQ for the N. meningitidis serogroup W at Day 1||5.77|-7.24|
72535849|NCT03433482|144601399|OTHER||Difference in percentage of subjects|-1.12|||||TWO_SIDED|95.0|-6.99|4.75|||Miettinen and Nurminen score method|||Between-group difference in percentages of subjects with hSBA titer ≥LLOQ for the N. meningitidis serogroup Y at Day 1||4.75|-6.99|
72535850|NCT03433482|144601399|OTHER||Difference in percentage of subjects|-0.64|||||TWO_SIDED|95.0|-4.24|2.96|||Miettinen and Nurminen score method|||Between-group difference in percentages of subjects with hSBA titer ≥LLOQ for the N. meningitidis serogroup A at Day 29||2.96|-4.24|
72535851|NCT03433482|144601399|OTHER||Difference in percentage of subjects|0.0|||||TWO_SIDED|95.0|-5.16|5.16|||Miettinen and Nurminen score method|||Between-group difference in percentages of subjects with hSBA titer ≥LLOQ for the N. meningitidis serogroup C at Day 29||5.16|-5.16|
72535852|NCT03433482|144601399|OTHER||Difference in percentage of subjects|4.09|||||TWO_SIDED|95.0|-1.11|9.33|||Miettinen and Nurminen score method|||Between-group difference in percentages of subjects with hSBA titer ≥LLOQ for the N. meningitidis serogroup W at Day 29||9.33|-1.11|
72535853|NCT03433482|144601399|OTHER||Difference in percentage of subjects|0.73|||||TWO_SIDED|95.0|-3.88|5.37|||Miettinen and Nurminen score method|||Between-group difference in percentages of subjects with hSBA titer ≥LLOQ for the N. meningitidis serogroup Y at Day 29||5.37|-3.88|
72535854|NCT00594568|144601417|SUPERIORITY_OR_OTHER|||||||0.134||95.0|||||Mixed Models Analysis|||||||0.134
72535855|NCT00594568|144601417|SUPERIORITY_OR_OTHER|||||||0.045||95.0|||||Mixed Models Analysis|||||||0.045
72535856|NCT00594568|144601417|SUPERIORITY_OR_OTHER|||||||0.61||95.0|||||Mixed Models Analysis|||||||0.610
72535857|NCT00594568|144601418|SUPERIORITY_OR_OTHER|||||||0.296||95.0|||||Mixed Models Analysis|||||||0.296
72535858|NCT00594568|144601418|SUPERIORITY_OR_OTHER|||||||0.172||95.0|||||Mixed Models Analysis|||||||0.172
72535859|NCT00594568|144601418|SUPERIORITY_OR_OTHER|||||||0.746||95.0|||||Mixed Models Analysis|||||||0.746
72535860|NCT00594568|144601419|SUPERIORITY_OR_OTHER|||||||0.166||95.0|||||Mixed Models Analysis|||||||0.166
72535861|NCT00594568|144601419|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Mixed Models Analysis|||||||<0.001
72535862|NCT00594568|144601419|SUPERIORITY_OR_OTHER|||||||0.014||95.0|||||Mixed Models Analysis|||||||0.014
72535863|NCT00594568|144601420|SUPERIORITY_OR_OTHER|||||||0.935||95.0|||||Mixed Models Analysis|||||||0.935
72535864|NCT00594568|144601420|SUPERIORITY_OR_OTHER|||||||0.068||95.0|||||Mixed Models Analysis|||||||0.068
72535865|NCT00594568|144601420|SUPERIORITY_OR_OTHER|||||||0.07||95.0|||||Mixed Models Analysis|||||||0.070
72535866|NCT00594568|144601421|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||ANCOVA|||||||0.002
72535867|NCT00594568|144601421|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||||||<0.001
72535868|NCT00594568|144601421|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||||||<0.001
72535869|NCT00594568|144601422|SUPERIORITY_OR_OTHER|||||||0.038||95.0|||||ANCOVA|||||||0.038
72535870|NCT00594568|144601422|SUPERIORITY_OR_OTHER|||||||0.147||95.0|||||ANCOVA|||||||0.147
72535871|NCT00594568|144601422|SUPERIORITY_OR_OTHER|||||||0.604||95.0|||||ANCOVA|||||||0.604
72535872|NCT00594568|144601423|SUPERIORITY_OR_OTHER|||||||0.143||95.0||||This is the p-value for the Left Hippocampal Volume|ANCOVA|||||||0.143
72535873|NCT00594568|144601423|SUPERIORITY_OR_OTHER|||||||0.464||95.0||||This is the p-value for the Left Hippocampal Volume|ANCOVA|||||||0.464
72535874|NCT00594568|144601423|SUPERIORITY_OR_OTHER|||||||0.025||95.0||||This is the p-value for the Left Hippocampal Volume|ANCOVA|||||||0.025
72535875|NCT00594568|144601423|SUPERIORITY_OR_OTHER|||||||0.347||95.0||||This is the p-value for the Right Hippocampal Volume|ANCOVA|||||||0.347
72535876|NCT00594568|144601423|SUPERIORITY_OR_OTHER|||||||0.82||95.0||||This is the p-value for the Right Hippocampal Volume|ANCOVA|||||||0.820
72535877|NCT00594568|144601423|SUPERIORITY_OR_OTHER|||||||0.243||95.0||||This is the p-value for the Right Hippocampal Volume|ANCOVA|||||||0.243
72535878|NCT00594568|144601424|SUPERIORITY_OR_OTHER|||||||0.784||95.0|||||ANCOVA|||||||0.784
72535879|NCT00594568|144601424|SUPERIORITY_OR_OTHER|||||||0.931||95.0|||||ANCOVA|||||||0.931
72535880|NCT00594568|144601424|SUPERIORITY_OR_OTHER|||||||0.718||95.0|||||ANCOVA|||||||0.718
72408605|NCT04035486|144325806|SUPERIORITY||Hazard Ratio (HR)|0.62||||0.0002|TWO_SIDED|95.0|0.48|0.8|||Log Rank||A hazard ratio of less than 1 favors the Osimertinib (AZD9291) + Chemo treatment arm.|The analysis was performed using a log rank test stratified by race (Chinese/Asian vs. Non-Chinese/Asian vs. Non-Asian), WHO performance status (0 vs. 1), and method used for tissue testing (central vs. local).||0.80|0.48|0.0002
72408606|NCT04035486|144325811|OTHER||Percentage of Participants|100.0|||||TWO_SIDED|95.0|88.43|100.0|||Clopper-Pearson|||A 95% CI was calculated on the percentage of participants with a Response or Stable Disease using the exact (Clopper-Pearson) method.||100.00|88.43|
72408607|NCT04035486|144325812|SUPERIORITY||Hazard Ratio (HR)|0.9||||0.5238|TWO_SIDED|95.0|0.65|1.24|||Log Rank||A hazard ratio of less than 1 favors the Osimertinib (AZD9291) + Chemo treatment arm.|The analysis was performed using a log rank test stratified by race (Chinese/Asian vs. Non-Chinese/Asian vs. Non-Asian), WHO performance status (0 vs. 1), and method used for tissue testing (central vs. local).|An adjusted CI of (0.54, 1.51) was computed at the 2-sided 99.84% level, considering a 2-sided significance level of 0.00158 for the overall survival interim analysis, based on the O'Brien and Fleming spending function, assuming 334 deaths for the final overall survival analysis.|1.24|0.65|0.5238
72408608|NCT04035486|144325814|SUPERIORITY||Odds Ratio (OR)|1.61||||0.0261|TWO_SIDED|95.0|1.06|2.44|||Regression, Logistic||And odds ratio of greater than 1 favors the Osimertinib (AZD9291) + Chemo treatment arm.|The analysis was performed using a logistic regression stratified by race (Chinese/Asian vs. Non-Chinese/Asian vs. Non-Asian), WHO performance status (0 vs. 1), and method used for tissue testing (central vs. local).||2.44|1.06|0.0261
72408609|NCT04035486|144325816|SUPERIORITY||Least Square Mean Difference|-3.36||||0.1067|TWO_SIDED|95.0|-7.44|0.72|||ANCOVA||A difference in least square means less than 0 favors the Osimertinib (AZD9291) + Chemo treatment arm.|The analysis was performed using analysis of covariance with baseline tumor size and time from baseline scan to randomization as covariates and with factors race (Chinese/Asian vs. Non-Chinese/Asian vs. Non-Asian), WHO performance status (0 vs. 1), and method used for tissue testing (central vs. local).||0.72|-7.44|0.1067
72408610|NCT04035486|144325817|SUPERIORITY||Odds Ratio (OR)|1.33||||0.4483|TWO_SIDED|95.0|0.63|2.81|||Regression, Logistic||An odds ratio greater than 1 favors the Osimertinib (AZD9291) + Chemo treatment arm.|The analysis was performed using a logistic regression stratified by race (Chinese/Asian vs. Non-Chinese/Asian vs. Non-Asian), WHO performance status (0 vs. 1), and method used for tissue testing (central vs. local).||2.81|0.63|0.4483
72408611|NCT04035486|144325818|SUPERIORITY||Hazard Ratio (HR)|0.7||||0.0132|TWO_SIDED|95.0|0.52|0.93|||Log Rank||A hazard ratio less than 1 favors the Osimertinib (AZD9291) + Chemo treatment arm.|The analysis was performed using a log rank test stratified by race (Chinese/Asian vs. Non-Chinese/Asian vs. Non-Asian), WHO performance status (0 vs. 1), and method used for tissue testing (central vs. local).||0.93|0.52|0.0132
72408612|NCT04035486|144325819|SUPERIORITY||Hazard Ratio (HR)|0.73||||0.0159|TWO_SIDED|95.0|0.56|0.94|||Log Rank||A hazard ratio less than 1 favors the Osimertinib (AZD9291) + Chemo treatment arm.|The analysis was performed using a log rank test stratified by race (Chinese/Asian vs. Non-Chinese/Asian vs. Non-Asian), WHO performance status (0 vs. 1), and method used for tissue testing (central vs. local).||0.94|0.56|0.0159
72408613|NCT04035486|144325820|SUPERIORITY||Hazard Ratio (HR)|0.69||||0.0157|TWO_SIDED|95.0|0.51|0.93|||Log Rank||A hazard ratio less than 1 favors the Osimertinib (AZD9291) + Chemo treatment arm.|The analysis was performed using a log rank test stratified by race (Chinese/Asian vs. Non-Chinese/Asian vs. Non-Asian), WHO performance status (0 vs. 1), and method used for tissue testing (central vs. local).||0.93|0.51|0.0157
72408614|NCT04035486|144325827|SUPERIORITY||Hazard Ratio (HR)|0.6|||||TWO_SIDED|95.0|0.44|0.83|||Cox proportional hazards model||A hazard ratio less than 1 favors the Osimertinib (AZD9291) + Chemo treatment arm.|Subgroup analysis was performed using a Cox proportional hazards model including treatment, subgroup and a treatment-by subgroup interaction term.||0.83|0.44|
72535881|NCT00594568|144601425|SUPERIORITY_OR_OTHER|||||||0.634||95.0|||||ANCOVA|||||||0.634
72408615|NCT04035486|144325828|SUPERIORITY||Hazard Ratio (HR)|0.63|||||TWO_SIDED|95.0|0.44|0.9|||||A hazard ratio less than 1 favors the Osimertinib (AZD9291) + Chemo treatment arm.|Subgroup analysis was performed using a Cox proportional hazards model including treatment, subgroup and a treatment-by subgroup interaction term.||0.90|0.44|
72408616|NCT00451282|144325855|SUPERIORITY_OR_OTHER|||||||0.69|||||||t-test, 2 sided|||||||.69
72408617|NCT00451282|144325856|SUPERIORITY_OR_OTHER|||||||0.89|||||||t-test, 2 sided|||||||.89
72408618|NCT00451282|144325857|SUPERIORITY_OR_OTHER|||||||0.69|||||||t-test, 2 sided|||||||.69
72408619|NCT00451282|144325858|SUPERIORITY_OR_OTHER|||||||0.18|||||||t-test, 2 sided|||||||.18
72408620|NCT01268644|144325869|SUPERIORITY|||||||0.14||||||P value comparing baseline to week 12|Mixed Models Analysis|||||||0.14
72535882|NCT00594568|144601425|SUPERIORITY_OR_OTHER|||||||0.901||95.0|||||ANCOVA|||||||0.901
72535883|NCT00594568|144601425|SUPERIORITY_OR_OTHER|||||||0.659||95.0|||||ANCOVA|||||||0.659
72408621|NCT01268644|144325870|SUPERIORITY|||||||0.01||||||P value comparing week 0 with week 12.|Mixed Models Analysis|||||||0.01
72408622|NCT01268644|144325871|SUPERIORITY|||||||0.009||||||P value comparing week 0 to week 12.|Mixed Models Analysis|||||||0.009
72408623|NCT01268644|144325872|SUPERIORITY|||||||0.75|||||||Mixed Models Analysis|||||||0.75
72535884|NCT00594568|144601428|SUPERIORITY_OR_OTHER|||||||0.062||95.0|||||Mixed Models Analysis|||||||0.062
72535885|NCT00594568|144601428|SUPERIORITY_OR_OTHER|||||||0.022||95.0|||||Mixed Models Analysis|||||||0.022
72535886|NCT00594568|144601428|SUPERIORITY_OR_OTHER|||||||0.669||95.0|||||Mixed Models Analysis|||||||0.669
72535887|NCT00594568|144601429|SUPERIORITY_OR_OTHER|||||||0.071||95.0|||||Mixed Models Analysis|||||||0.071
72535888|NCT00594568|144601429|SUPERIORITY_OR_OTHER|||||||0.018||95.0|||||Mixed Models Analysis|||||||0.018
72535889|NCT00594568|144601429|SUPERIORITY_OR_OTHER|||||||0.571||95.0|||||Mixed Models Analysis|||||||0.571
72535890|NCT00594568|144601430|SUPERIORITY_OR_OTHER|||||||0.518||95.0|||||Mixed Models Analysis|||||||0.518
72535891|NCT00594568|144601430|SUPERIORITY_OR_OTHER|||||||0.013||95.0|||||Mixed Models Analysis|||||||0.013
72535892|NCT00594568|144601430|SUPERIORITY_OR_OTHER|||||||0.072||95.0|||||Mixed Models Analysis|||||||0.072
72535893|NCT00594568|144601431|SUPERIORITY_OR_OTHER|||||||0.069||95.0|||||Mixed Models Analysis|||||||0.069
72628221|NCT00492557|144784517|NON_INFERIORITY_OR_EQUIVALENCE|The criterion upon which to declare non-inferiority was if the lower limit of the 2-sided 95%CI for the GMT ratios, (13vPnC+TIV relative to 13vPnC administered 1 month after TIV+placebo) was greater than 0.5 (2-fold criterion).|GMT Ratio|0.7|||||TWO_SIDED|95.0|0.47|1.12|||||2-sided 95% CIs for the GMT ratio were calculated by back transformations of the 95% CIs based on the Student t distribution for the mean difference of the logarithmically transformed assay results.|Serotype 7F. The primary null hypothesis was: the log of the GMT in the group receiving 13vPnC + TIV minus the log of the GMT in the group receiving 13vPnC alone (1 month after TIV) \<= -0.693.||1.12|0.47|
72408624|NCT01416194|144325873|SUPERIORITY||Hazard Ratio (HR)|0.4|||<|0.01|TWO_SIDED|95.0|0.3|0.7|||Regression, Logistic|||The hazard ratio from Cox proportional hazard regression models was used for comparison of event rates of the primary and secondary endpoints in each treatment group. Statistical two-sided tests was used with a significance level of 0.05.||0.7|0.3|<0.01
72408625|NCT01416194|144325873|SUPERIORITY||Hazard Ratio (HR)|1.0||||0.91|TWO_SIDED|95.0|0.4|2.2|||Regression, Logistic|||The hazard ratio from Cox proportional hazard regression models was used for comparison of event rates of the primary and secondary endpoints in each treatment group. Statistical two-sided tests was used with a significance level of 0.05.||2.2|0.4|0.91
72408626|NCT01416194|144325874|SUPERIORITY||Hazard Ratio (HR)|0.5|||<|0.01|TWO_SIDED|95.0|0.3|0.7|||Regression, Logistic|||The hazard ratio from Cox proportional hazard regression models was used for comparison of event rates of the primary and secondary endpoints in each treatment group. Statistical two-sided tests was used with a significance level of 0.05.||0.7|0.3|<0.01
72535894|NCT00594568|144601431|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||Mixed Models Analysis|||||||0.002
72535895|NCT00594568|144601431|SUPERIORITY_OR_OTHER|||||||0.198||95.0|||||Mixed Models Analysis|||||||0.198
72535896|NCT00594568|144601432|SUPERIORITY_OR_OTHER|||||||0.127||95.0|||||Mixed Models Analysis|||||||0.127
72535897|NCT00594568|144601432|SUPERIORITY_OR_OTHER|||||||0.016||95.0|||||Mixed Models Analysis|||||||0.016
72535898|NCT00594568|144601432|SUPERIORITY_OR_OTHER|||||||0.381||95.0|||||Mixed Models Analysis|||||||0.381
72535899|NCT00594568|144601433|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Mixed Models Analysis|||||||<0.001
72535900|NCT00594568|144601433|SUPERIORITY_OR_OTHER|||||||0.005||95.0|||||Mixed Models Analysis|||||||0.005
72535901|NCT00594568|144601433|SUPERIORITY_OR_OTHER|||||||0.141||95.0|||||Mixed Models Analysis|||||||0.141
72535902|NCT00594568|144601434|SUPERIORITY_OR_OTHER|||||||0.337||95.0|||||ANCOVA|||||||0.337
72535903|NCT00594568|144601434|SUPERIORITY_OR_OTHER|||||||0.018||95.0|||||ANCOVA|||||||0.018
72535904|NCT00594568|144601434|SUPERIORITY_OR_OTHER|||||||0.157||95.0|||||ANCOVA|||||||0.157
72535905|NCT00594568|144601435|SUPERIORITY_OR_OTHER|||||||0.186||95.0|||||Mixed Models Analysis|||||||0.186
72535906|NCT00594568|144601435|SUPERIORITY_OR_OTHER|||||||0.149||95.0|||||Mixed Models Analysis|||||||0.149
72535907|NCT00594568|144601435|SUPERIORITY_OR_OTHER|||||||0.889||95.0|||||Mixed Models Analysis|||||||0.889
72535908|NCT00594568|144601436|SUPERIORITY_OR_OTHER|||||||0.202||95.0|||||Mixed Models Analysis|||||||0.202
72535909|NCT00594568|144601436|SUPERIORITY_OR_OTHER|||||||0.075||95.0|||||Mixed Models Analysis|||||||0.075
72535910|NCT00594568|144601436|SUPERIORITY_OR_OTHER|||||||0.616||95.0|||||Mixed Models Analysis|||||||0.616
72535911|NCT04311411|144601444|SUPERIORITY||Median Difference (Final Values)|-534.11|||<|0.0001|TWO_SIDED|95.0|-668.2|-400.02|||ANCOVA|||||-400.02|-668.20|<.0001
72535912|NCT04311411|144601445|SUPERIORITY||Median Difference (Final Values)|0.0439||||0.5437|TWO_SIDED|95.0|-0.0994|0.1871|||Mixed Models Analysis|||Insula||0.1871|-0.0994|0.5437
72535913|NCT04311411|144601445|SUPERIORITY||Mean Difference (Final Values)|0.093||||0.1806|TWO_SIDED|95.0|-0.0441|0.2301|||Mixed Models Analysis|||Insula||0.2301|-0.0441|0.1806
72535914|NCT04311411|144601445|SUPERIORITY||Mean Difference (Final Values)|-0.0491||||0.472|TWO_SIDED|95.0|-0.1846|0.0863|||Mixed Models Analysis|||Insula||0.0863|-0.1846|0.4720
72535915|NCT04311411|144601445|SUPERIORITY||Mean Difference (Final Values)|-0.0011||||0.9842|TWO_SIDED|95.0|-0.1079|0.1058|||Mixed Models Analysis|||Medial frontal gyrus||0.1058|-0.1079|0.9842
72535916|NCT04311411|144601445|SUPERIORITY||Mean Difference (Final Values)|0.0077||||0.8822|TWO_SIDED|95.0|-0.0949|0.1102|||Mixed Models Analysis|||Medial frontal gyrus||0.1102|-0.0949|0.8822
72535917|NCT04311411|144601445|SUPERIORITY||Mean Difference (Final Values)|-0.0087||||0.8657|TWO_SIDED|95.0|-0.1111|0.0937|||Mixed Models Analysis|||Medial frontal gyrus||0.0937|-0.1111|0.8657
72535918|NCT04311411|144601445|SUPERIORITY||Mean Difference (Final Values)|0.0043||||0.9599|TWO_SIDED|95.0|-0.165|0.1736|||Mixed Models Analysis|||Superior temporal gyrus||0.1736|-0.1650|0.9599
72535919|NCT04311411|144601445|SUPERIORITY||Mean Difference (Final Values)|0.0489||||0.549|TWO_SIDED|95.0|-0.1129|0.2107|||Mixed Models Analysis|||Superior temporal gyrus||0.2107|-0.1129|0.5490
72535920|NCT04311411|144601445|SUPERIORITY||Mean Difference (Final Values)|-0.0446||||0.5854|TWO_SIDED|95.0|-0.2068|0.1176|||Mixed Models Analysis|||Superior temporal gyrus||0.1176|-0.2068|0.5854
72535921|NCT04311411|144601445|SUPERIORITY||Mean Difference (Final Values)|-0.0192||||0.7203|TWO_SIDED|95.0|-0.1259|0.0874|||Mixed Models Analysis|||Precentral gyrus||0.0874|-0.1259|0.7203
72535922|NCT04311411|144601445|SUPERIORITY||Mean Difference (Final Values)|0.0404||||0.433|TWO_SIDED|95.0|-0.0617|0.1425|||Mixed Models Analysis|||Precentral gyrus||0.1425|-0.0617|0.4330
72535923|NCT04311411|144601445|SUPERIORITY||Mean Difference (Final Values)|-0.0596||||0.2488|TWO_SIDED|95.0|-0.1619|0.0426|||Mixed Models Analysis|||Precentral gyrus||0.0426|-0.1619|0.2488
72535924|NCT04311411|144601445|SUPERIORITY||Mean Difference (Final Values)|-0.007||||0.8886|TWO_SIDED|95.0|-0.1059|0.0919|||Mixed Models Analysis|||Cingulate gyrus||0.0919|-0.1059|0.8886
72535925|NCT04311411|144601445|SUPERIORITY||Mean Difference (Final Values)|0.0684||||0.1563|TWO_SIDED|95.0|-0.0267|0.1635|||Mixed Models Analysis|||Cingulate gyrus||0.1635|-0.0267|0.1563
72535926|NCT04311411|144601445|SUPERIORITY||Mean Difference (Final Values)|-0.0754||||0.1182|TWO_SIDED|95.0|-0.1704|0.0196|||Mixed Models Analysis|||Cingulate gyrus||0.0196|-0.1704|0.1182
72535927|NCT04311411|144601446|SUPERIORITY||Mean Difference (Final Values)|20.57|||<|0.0001|TWO_SIDED|95.0|12.11|29.02|||Mixed Models Analysis|||Fasting (Pre-lunch)||29.02|12.11|<.0001
72573210|NCT03118570|144673098|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.204||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 12||||0.204
72408627|NCT01416194|144325874|SUPERIORITY||Hazard Ratio (HR)|1.1||||0.76|TWO_SIDED|95.0|0.5|2.4|||Regression, Logistic|||The hazard ratio from Cox proportional hazard regression models was used for comparison of event rates of the primary and secondary endpoints in each treatment group. Statistical two-sided tests was used with a significance level of 0.05.||2.4|0.5|0.76
72408628|NCT01416194|144325875|SUPERIORITY||Hazard Ratio (HR)|0.6||||0.01|TWO_SIDED|95.0|0.3|0.9|||Regression, Logistic|||The hazard ratio from Cox proportional hazard regression models was used for comparison of event rates of the primary and secondary endpoints in each treatment group. Statistical two-sided tests was used with a significance level of 0.05.||0.9|0.3|0.01
72408629|NCT01416194|144325875|SUPERIORITY||Hazard Ratio (HR)|0.7||||0.37|TWO_SIDED|95.0|0.4|1.5|||Regression, Logistic|||The hazard ratio from Cox proportional hazard regression models was used for comparison of event rates of the primary and secondary endpoints in each treatment group. Statistical two-sided tests was used with a significance level of 0.05.||1.5|0.4|0.37
72408630|NCT01416194|144325876|SUPERIORITY||Hazard Ratio (HR)|0.7||||0.1|TWO_SIDED|95.0|0.5|1.1|||Regression, Logistic|||The hazard ratio from Cox proportional hazard regression models was used for comparison of event rates of the primary and secondary endpoints in each treatment group. Statistical two-sided tests was used with a significance level of 0.05.||1.1|0.5|0.10
72408631|NCT01416194|144325876|SUPERIORITY||Hazard Ratio (HR)|0.7||||0.19|TWO_SIDED|95.0|0.4|1.2|||Regression, Logistic|||The hazard ratio from Cox proportional hazard regression models was used for comparison of event rates of the primary and secondary endpoints in each treatment group. Statistical two-sided tests was used with a significance level of 0.05.||1.2|0.4|0.19
72408632|NCT01416194|144325877|SUPERIORITY||Hazard Ratio (HR)|0.4|||<|0.01|TWO_SIDED|95.0|0.3|0.7|||Regression, Logistic|||The hazard ratio from Cox proportional hazard regression models was used for comparison of event rates of the primary and secondary endpoints in each treatment group. Statistical two-sided tests was used with a significance level of 0.05.||0.7|0.3|<0.01
72573211|NCT03118570|144673099|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.588||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 6||||0.588
72573212|NCT03118570|144673099|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.697||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 6||||0.697
72573213|NCT03118570|144673099|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.283||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 6||||0.283
72408633|NCT01416194|144325877|SUPERIORITY||Hazard Ratio (HR)|1.0||||0.9|TWO_SIDED|95.0|0.4|2.1|||Regression, Linear|||The hazard ratio from Cox proportional hazard regression models was used for comparison of event rates of the primary and secondary endpoints in each treatment group. Statistical two-sided tests was used with a significance level of 0.05.||2.1|0.4|0.90
72408634|NCT01416194|144325878|SUPERIORITY||Hazard Ratio (HR)|1.9|||<|0.01|TWO_SIDED|95.0|1.4|2.5|||Regression, Logistic|||The hazard ratio from Cox proportional hazard regression models was used for comparison of event rates of the primary and secondary endpoints in each treatment group. Statistical two-sided tests was used with a significance level of 0.05.||2.5|1.4|<0.01
72408635|NCT01416194|144325878|SUPERIORITY||Hazard Ratio (HR)|0.9||||0.74|TWO_SIDED|95.0|0.7|1.3|||Regression, Logistic|||The hazard ratio from Cox proportional hazard regression models was used for comparison of event rates of the primary and secondary endpoints in each treatment group. Statistical two-sided tests was used with a significance level of 0.05.||1.3|0.7|0.74
72573214|NCT03118570|144673099|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.354||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 12||||0.354
72408636|NCT01416194|144325879|SUPERIORITY||Hazard Ratio (HR)|0.4|||<|0.01|TWO_SIDED|95.0|0.3|0.6|||Regression, Logistic|||The hazard ratio from Cox proportional hazard regression models was used for comparison of event rates of the primary and secondary endpoints in each treatment group. Statistical two-sided tests was used with a significance level of 0.05.||0.6|0.3|<0.01
72408637|NCT01416194|144325879|SUPERIORITY||Hazard Ratio (HR)|0.6||||0.01|TWO_SIDED|95.0|0.4|0.9|||Regression, Logistic|||The hazard ratio from Cox proportional hazard regression models was used for comparison of event rates of the primary and secondary endpoints in each treatment group. Statistical two-sided tests was used with a significance level of 0.05.||0.9|0.4|0.01
72573215|NCT03118570|144673099|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.43||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 12||||0.430
72408638|NCT01416194|144325880|SUPERIORITY||Hazard Ratio (HR)|0.3|||<|0.01|TWO_SIDED|95.0|0.1|0.5|||Regression, Linear|||The hazard ratio from Cox proportional hazard regression models was used for comparison of event rates of the primary and secondary endpoints in each treatment group. Statistical two-sided tests was used with a significance level of 0.05.||0.5|0.1|<0.01
72573216|NCT03118570|144673099|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.091||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 12||||0.091
72408639|NCT01416194|144325880|SUPERIORITY||Hazard Ratio (HR)|0.4||||0.06|TWO_SIDED|95.0|0.2|1.1|||Regression, Linear|||The hazard ratio from Cox proportional hazard regression models was used for comparison of event rates of the primary and secondary endpoints in each treatment group. Statistical two-sided tests was used with a significance level of 0.05.||1.1|0.2|0.06
72535928|NCT04311411|144601446|SUPERIORITY||Mean Difference (Final Values)|6.63||||0.1097|TWO_SIDED|95.0|-1.53|14.79||Fasting|Mixed Models Analysis|||Fasting (Pre-lunch)||14.79|-1.53|0.1097
72535929|NCT04311411|144601446|SUPERIORITY||Mean Difference (Final Values)|13.94||||0.0015|TWO_SIDED|95.0|5.49|22.38|||Mixed Models Analysis|||Fasting (Pre-lunch)||22.38|5.49|0.0015
72535930|NCT04311411|144601446|SUPERIORITY||Mean Difference (Final Values)|2.25||||0.4469|TWO_SIDED|95.0|-3.6|8.09|||Mixed Models Analysis|||Postprandial (Post-lunch)||8.09|-3.60|0.4469
72535931|NCT04311411|144601446|SUPERIORITY||Mean Difference (Final Values)|0.64||||0.8227|TWO_SIDED|95.0|-5.02|6.31|||Mixed Models Analysis|||Postprandial (Post-lunch)||6.31|-5.02|0.8227
72535932|NCT04311411|144601446|SUPERIORITY||Mean Difference (Final Values)|1.61||||0.5861|TWO_SIDED|95.0|-4.23|7.45|||Mixed Models Analysis|||Postprandial (Post-lunch)||7.45|-4.23|0.5861
72535933|NCT03722849|144601482|OTHER||||||=|0.0028||||||No multiple comparisons as region of interest analysis defined a priori.|Wilcoxon (Mann-Whitney)|||Mann-Whitney U tests for non-parametric data||||=0.0028
72535934|NCT03722849|144601483|OTHER||||||=|0.007||||||No multiple comparisons as region of interest analysis defined a priori.|Wilcoxon (Mann-Whitney)|||Mann-Whitney U tests for non-parametric data||||=0.0070
72535935|NCT03722849|144601484|OTHER|Group comparisons (Cough versus healthy) for each measurement using repeated measures ANOVA.|||||=|0.0019|||||||ANOVA|with repeated measures||||||=0.0019
72535936|NCT03722849|144601486|OTHER|Group-wise comparisons using unpaired t-tests or one way ANOVA|||||<|0.0001|||||||ANOVA|||||||<0.0001
72535937|NCT05644756|144601487|OTHER|The primary analysis examined changes in measurement-based care (MBC) collection over time using ANOVA. The study was not designed as a superiority, non-inferiority, or equivalence trial.|||||>|0.01|||||||ANOVA|||||||>.01
72535938|NCT03985982|144601488|SUPERIORITY||||||<|0.001||||||This outcome measure is the first to be assessed in a hierarchical testing sequence using a one-sided alpha of 0.025.|Cochran-Mantel-Haenszel|||||||<0.001
72535939|NCT03985982|144601489|SUPERIORITY||||||<|0.001||||||The statistical significance is set to 0.025. This is the second test in a hierarchical testing sequence. Statistical significance will only be assessed if the previous test shows statistical significance at the 1-sided alpha level of 0.025.|Wilcoxon (Mann-Whitney)|||Test performed for Modified Skindex-16 (GL-QoL) Emotional domain - Change from Baseline at Week 4||||<0.001
72535940|NCT03985982|144601489|SUPERIORITY||||||<|0.001||||||The statistical significance is set to 0.025. This is the third test in a hierarchical testing sequence. Statistical significance will only be assessed if the previous two tests show statistical significance at the alpha level of 0.025.|Wilcoxon (Mann-Whitney)|||Test performed for Modified Skindex-16 (GL-QoL) Social Functioning domain - Change from Baseline at Week 4||||<0.001
72535941|NCT03985982|144601489|SUPERIORITY||||||<|0.001||||||The statistical significance is set to 0.025. This is the forth test in a hierarchical testing sequence. Statistical significance will only be assessed if the previous three tests show statistical significance at the 1-sided alpha level of 0.025.|Wilcoxon (Mann-Whitney)|||Test performed for Modified Skindex-16 (GL-QoL) Overall score - Change from Baseline at Week 4.||||<0.001
72535942|NCT03985982|144601489|SUPERIORITY||||||<|0.001||||||The statistical significance is set to 0.025. This is the fifth test in a hierarchical testing sequence. Statistical significance will only be assessed if the previous four tests show statistical significance at the 1-sided alpha level of 0.025.|Wilcoxon (Mann-Whitney)|||Test performed for FACE-Q Appraisal of Lines Between Eyebrows - Change from Baseline at Week 4||||<0.001
72535943|NCT03985982|144601489|SUPERIORITY||||||<|0.001||||||The statistical significance is set to 0.025. This is the sixth test in a hierarchical testing sequence. Statistical significance will only be assessed if the previous five tests show statistical significance at the 1-sided alpha level of 0.025.|Wilcoxon (Mann-Whitney)|||Test performed for FACE-Q Age Appraisal VAS score||||<0.001
72535944|NCT03478982|144601515|SUPERIORITY||Difference in percentage|23.3|||=|0.0392|TWO_SIDED|95.0|1.8|44.8|||Chi-squared|||||44.8|1.8|=0.0392
72535945|NCT03478982|144601515|SUPERIORITY||Difference in percentage|23.3|||=|0.0392|TWO_SIDED|95.0|1.8|44.8|||Chi-squared|||||44.8|1.8|=0.0392
72535946|NCT00659945|144601523|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Chi-squared|||The primary endpoint was the incidence of emesis at any time within the first 48 hours after surgery. Power analysis showed that a sample size of 69 patients per group was necessary to detect a significant decrease in the incidence of emesis from 33% in the placebo group to 15% in the aprepitant group using a Chi-square test with an alpha value of 0.05 and power of 80%.||||<0.05
72535947|NCT00943826|144601524|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.64|||<|0.0001|TWO_SIDED|95.0|0.55|0.74||Stratified by Region and Recursive partitioning analysis (RPA) Class|Log Rank||Stratified by Region and RPA Class.|||0.74|0.55|<0.0001
72535948|NCT00943826|144601525|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.88||||0.0987|TWO_SIDED|95.0|0.76|1.02|||Log Rank|Stratified by Region and RPA Class|Stratified by Region and RPA Class.|||1.02|0.76|0.0987
72535949|NCT00943826|144601526|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.61|||<|0.0001|TWO_SIDED|95.0|0.53|0.71||Stratified by Region and RPA Class.|Log Rank||Stratified by Region and RPA Class.|||0.71|0.53|<0.0001
72535950|NCT00326625|144601531|SUPERIORITY||Slope difference|-0.06|STANDARD_ERROR_OF_MEAN|0.083||0.4807|TWO_SIDED|95.0|-0.22|0.1|||ANCOVA||Glatiramer acetate vs. Placebo|Analysis compares the ALSFRS-R slopes of change from baseline between treatment groups. Analysis includes the following covariates: time from randomization, treatment group, time by treatment interaction, center, Riluzole use, age, site of ALS onset, time from ALS onset and baseline ALSFRS-R score.||0.10|-0.22|0.4807
72535951|NCT00326625|144601532|SUPERIORITY||Hazard Ratio (HR)|1.06||||0.8583|TWO_SIDED|95.0|0.56|2.005|||Regression, Cox||Glatiramer acetate vs. Placebo|Analysis covariates are center, riluzole use, site of ALS onset, time from ALS onset, baseline ALSFRS-R score, baseline slow vital capacity (VC) and baseline body mass index (BMI).||2.005|0.560|0.8583
72535952|NCT00517868|144601533|NON_INFERIORITY|A paired student t comparison was used to assess treatment differences as measured by 11 point numerical rating scale.|Mean Difference (Final Values)|-21.14||||0.0363|TWO_SIDED|95.0|-44.43|2.16|||t-test, 1 sided|||||2.16|-44.43|0.0363
72573217|NCT03118570|144673100|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.527||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 6||||0.527
72573218|NCT03118570|144673100|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.738||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 6||||0.738
72573219|NCT03118570|144673100|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.465||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 6||||0.465
72573220|NCT03118570|144673100|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.068||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 12||||0.068
72573221|NCT03118570|144673100|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.328||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 12||||0.328
72408640|NCT01416194|144325881|SUPERIORITY||Hazard Ratio (HR)|0.5|||<|0.01|TWO_SIDED|95.0|0.3|0.7|||Regression, Linear|||The hazard ratio from Cox proportional hazard regression models was used for comparison of event rates of the primary and secondary endpoints in each treatment group. Statistical two-sided tests was used with a significance level of 0.05.||0.7|0.3|<0.01
72408641|NCT01416194|144325881|SUPERIORITY||Hazard Ratio (HR)|0.8||||0.38|TWO_SIDED|95.0|0.5|1.4|||Regression, Linear|||The hazard ratio from Cox proportional hazard regression models was used for comparison of event rates of the primary and secondary endpoints in each treatment group. Statistical two-sided tests was used with a significance level of 0.05.||1.4|0.5|0.38
72535953|NCT02234427|144601545|SUPERIORITY_OR_OTHER||||||<|5e-06||||||Above noted p-value is adjusted for multiple comparisons. Analysis was performed using the TopHat/Cufflinks pipeline. The differential expression algorithm uses a beta distribution and the overdispersion with a negative binomial distribution.|negative binomial|||Null Hypothesis: There is no difference in gene expression before and after aspirin therapy||||<0.000005
72535954|NCT01265875|144601546|SUPERIORITY_OR_OTHER|||||||0.25|TWO_SIDED||||||t-test, 2 sided|||Change from baseline to day 4.||||.25
72535955|NCT01265875|144601546|SUPERIORITY_OR_OTHER|||||||0.19|TWO_SIDED||||||t-test, 2 sided|||Change from baseline to day 7.||||.19
72535956|NCT01265875|144601546|SUPERIORITY_OR_OTHER|||||||0.27|TWO_SIDED||||||t-test, 2 sided|||Change from baseline to Day 30.||||.27
72535957|NCT01265875|144601548|SUPERIORITY_OR_OTHER|||||||0.52|TWO_SIDED||||||t-test, 2 sided|||Change from baseline to Day 4.||||.52
72535958|NCT01265875|144601548|SUPERIORITY_OR_OTHER|||||||0.34|TWO_SIDED||||||t-test, 2 sided|||Change from baseline to Day 30.||||.34
72535959|NCT02279888|144601563|OTHER|the lower limit of the two-sided 95% confidence interval on the freedom from DSRC rate at 24 months is greater than 80%|Kaplan Meier|0.05|||<|0.0001|TWO_SIDED||||||t-test, 2 sided|||||||<0.0001
72535960|NCT02279888|144601565|OTHER||Hazard Ratio (HR)|0.43|||<|0.0001|TWO_SIDED|95.0|0.39|0.47|||Andersen-Gill||This analysis applies to Primary Outcome: HFH Rate|||0.47|0.39|<0.0001
72535961|NCT02279888|144601567|OTHER||Hazard Ratio (HR)|0.57|||<|0.0001|TWO_SIDED|95.0|0.52|0.62|||Andersen-Gill|||||0.62|0.52|<0.0001
72535962|NCT00650806|144601605|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|0.4||0.031|TWO_SIDED|95.0|-1.6|-0.1|||ANOVA|Cofactors were treatment, run-in weight loss stratum, and pooled center.||||-0.1|-1.6|0.031
72535963|NCT00650806|144601605|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-1.6|STANDARD_ERROR_OF_MEAN|0.4|<|0.001|TWO_SIDED|95.0|-2.4|-0.8|||ANOVA|Cofactors were treatment, run-in weight loss stratum, and pooled center.||||-0.8|-2.4|<0.001
72535964|NCT00650806|144601605|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-1.4|STANDARD_ERROR_OF_MEAN|0.4|<|0.001|TWO_SIDED|95.0|-2.1|-0.6|||ANOVA|Cofactors were treatment, run-in weight loss stratum, and pooled center.||||-0.6|-2.1|<0.001
72535965|NCT00650806|144601606|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.4||0.045|TWO_SIDED|95.0|-1.58|-0.02|||ANCOVA|Cofactors were treatment, run-in weight loss stratum, and pooled center. Baseline body weight was a covariate.||||-0.02|-1.58|0.045
72535966|NCT00650806|144601606|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-1.6|STANDARD_ERROR_OF_MEAN|0.41|<|0.001|TWO_SIDED|95.0|-2.4|-0.8|||ANCOVA|Cofactors were treatment, run-in weight loss stratum, and pooled center. Baseline body weight was a covariate.||||-0.80|-2.40|<0.001
72535967|NCT00650806|144601606|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-1.3|STANDARD_ERROR_OF_MEAN|0.4||0.001|TWO_SIDED|95.0|-2.07|-0.51|||ANCOVA|Cofactors were treatment, run-in weight loss stratum, and pooled center. Baseline body weight was a covariate.||||-0.51|-2.07|0.001
72535968|NCT00650806|144601607|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-0.31|STANDARD_ERROR_OF_MEAN|0.14||0.031|TWO_SIDED|95.0|-0.59|-0.03|||ANCOVA|Cofactors were treatment, run-in weight loss stratum, and pooled center. The corresponding baseline measurement was a covariate.||||-0.03|-0.59|0.031
72535969|NCT00650806|144601607|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.15|<|0.001|TWO_SIDED|95.0|-0.9|-0.32|||ANCOVA|Cofactors were treatment, run-in weight loss stratum, and pooled center. The corresponding baseline measurement was a covariate.||||-0.32|-0.90|<0.001
72573222|NCT03118570|144673100|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.277||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 12||||0.277
72535970|NCT00650806|144601607|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-0.48|STANDARD_ERROR_OF_MEAN|0.14|<|0.001|TWO_SIDED|95.0|-0.76|-0.2|||ANCOVA|Cofactors were treatment, run-in weight loss stratum, and pooled center. The corresponding baseline measurement was a covariate.||||-0.20|-0.76|<0.001
72535971|NCT00650806|144601608|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.7||||0.317||95.0|0.6|5.6||P-value controlled for run-in weight loss stratum and pooled center.|Cochran-Mantel-Haenszel||Odds ratio and Confidence Interval controlled for run-in weight loss stratum and pooled center.|||5.6|0.6|0.317
72535972|NCT00650806|144601608|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.9||||0.059|TWO_SIDED|95.0|0.9|11.1||P-value controlled for run-in weight loss stratum and pooled center.|Cochran-Mantel-Haenszel||Odds ratio and Confidence Interval controlled for run-in weight loss stratum and pooled center.|||11.1|0.9|0.059
72535973|NCT00650806|144601608|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.1||||0.027|TWO_SIDED|95.0|1.0|10.0||P-value controlled for run-in weight loss stratum and pooled center.|Cochran-Mantel-Haenszel||Odds ratio and Confidence Interval controlled for run-in weight loss stratum and pooled center.|||10.0|1.0|0.027
72535974|NCT00650806|144601609|SUPERIORITY_OR_OTHER|||||||0.117|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test controlled for run-in weight loss stratum and pooled center.||||||0.117
72535975|NCT00650806|144601609|SUPERIORITY_OR_OTHER|||||||0.225|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test controlled for run-in weight loss stratum and pooled center.||||||0.225
72535976|NCT00650806|144601609|SUPERIORITY_OR_OTHER|||||||0.317|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test controlled for run-in weight loss stratum and pooled center.||||||0.317
72408642|NCT01416194|144325883|SUPERIORITY||Hazard Ratio (HR)|1.2||||0.24|TWO_SIDED|95.0|0.9|1.5|||Regression, Linear|||The hazard ratio from Cox proportional hazard regression models was used for comparison of event rates of the primary and secondary endpoints in each treatment group. Statistical two-sided tests was used with a significance level of 0.05.||1.5|0.9|0.24
72535977|NCT00650806|144601610|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-0.26|STANDARD_ERROR_OF_MEAN|1.23||0.835|TWO_SIDED|95.0|-2.68|2.17|||ANCOVA|Cofactors were treatment, run-in weight loss stratum, and pooled center. The corresponding baseline measurement was a covariate.||||2.17|-2.68|0.835
72535978|NCT00650806|144601610|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-0.94|STANDARD_ERROR_OF_MEAN|1.29||0.466|TWO_SIDED|95.0|-3.47|1.59|||ANCOVA|Cofactors were treatment, run-in weight loss stratum, and pooled center. The corresponding baseline measurement was a covariate.||||1.59|-3.47|0.466
72535979|NCT00650806|144601610|SUPERIORITY_OR_OTHER||Least-Sqaures Mean Difference|-1.37|STANDARD_ERROR_OF_MEAN|1.25||0.273|TWO_SIDED|95.0|-3.87|1.09|||ANCOVA|Cofactors were treatment, run-in weight loss stratum, and pooled center. The corresponding baseline measurement was a covariate.||||1.09|-3.87|0.273
72535980|NCT00650806|144601611|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-1.63|STANDARD_ERROR_OF_MEAN|1.13||0.149|TWO_SIDED|95.0|-3.85|0.59|||ANCOVA|Cofactors were treatment, run-in weight loss stratum, and pooled center. The corresponding baseline measurement was a covariate.||||0.59|-3.85|0.149
72535981|NCT00650806|144601611|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-0.72|STANDARD_ERROR_OF_MEAN|1.18||0.541|TWO_SIDED|95.0|-3.05|1.6|||ANCOVA|Cofactors were treatment, run-in weight loss stratum, and pooled center. The corresponding baseline measurement was a covariate.||||1.6|-3.05|0.541
72535982|NCT00650806|144601611|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-1.78|STANDARD_ERROR_OF_MEAN|1.15||0.121|TWO_SIDED|95.0|-4.03|0.47|||ANCOVA|Cofactors were treatment, run-in weight loss stratum, and pooled center. The corresponding baseline measurement was a covariate.||||0.47|-4.03|0.121
72535983|NCT00650806|144601612|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|0.011|STANDARD_ERROR_OF_MEAN|0.0091||0.239|TWO_SIDED|95.0|-0.0071|0.0286|||ANCOVA|Cofactors were treatment, run-in weight loss stratum, and pooled center. The corresponding baseline measurement was a covariate.||||0.0286|-0.0071|0.239
72535984|NCT00650806|144601612|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|0.001|STANDARD_ERROR_OF_MEAN|0.0095||0.9|TWO_SIDED|95.0|-0.0174|0.0198|||ANCOVA|Cofactors were treatment, run-in weight loss stratum, and pooled center. The corresponding baseline measurement was a covariate.||||0.0198|-0.0174|0.900
72535985|NCT00650806|144601612|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|0.002|STANDARD_ERROR_OF_MEAN|0.0092||0.822|TWO_SIDED|95.0|-0.016|0.0202|||ANCOVA|Cofactors were treatment, run-in weight loss stratum, and pooled center. The corresponding baseline measurement was a covariate.||||0.0202|-0.0160|0.822
72535986|NCT04456998|144601613|SUPERIORITY||Mean Difference (Net)|-96.1||||0.031|TWO_SIDED|95.0|-183.5|-8.8|||ANCOVA||GB002 vs. Placebo|||-8.8|-183.5|0.0310
72535987|NCT04456998|144601614|SUPERIORITY||Mean Difference (Net)|6.5||||0.5972|TWO_SIDED|95.0|-17.9|30.9|||Mixed Models Analysis||GB002 vs. Placebo|||30.9|-17.9|0.5972
72535988|NCT00965562|144601634|SUPERIORITY_OR_OTHER|||||||0.15||95.0|||||Chi-squared|||||||0.15
72535989|NCT00965562|144601635|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||Chi-squared|||||||0.05
72535990|NCT00965562|144601636|SUPERIORITY_OR_OTHER|||||||0.06||95.0|||||Chi-squared|||||||0.06
72535991|NCT00965562|144601637|SUPERIORITY_OR_OTHER|||||||0.09||95.0|||||Chi-squared|||||||0.09
72535992|NCT00965562|144601638|SUPERIORITY_OR_OTHER|||||||0.005||95.0|||||Chi-squared|||||||0.005
72535993|NCT00965562|144601639|SUPERIORITY_OR_OTHER|||||||0.04||95.0|||||Chi-squared|||||||0.04
72535994|NCT00965562|144601640|SUPERIORITY_OR_OTHER||Slope|-2.63||||0.07|TWO_SIDED|95.0|-5.51|0.24|||Mixed Models Analysis||Slope represents average change in fluoxetine group IDS score as compared to placebo|||0.24|-5.51|0.07
72535995|NCT00965562|144601640|SUPERIORITY_OR_OTHER||Slope|-0.1||||0.94|TWO_SIDED|95.0|-2.85|2.65|||Mixed Models Analysis||Slope represents average change in calcium group IDS scores as compared to placebo|||2.65|-2.85|0.94
72535996|NCT00965562|144601640|SUPERIORITY_OR_OTHER||Cohen's d effect size|1.15||||0.07|TWO_SIDED||||||Mixed Models Analysis||Cohen's d effect sizes were calculated by subtracting the difference between changes in the fluoxetine group between visits 1 and 5 and changes in the placebo group between Visits 1 and 5, divided by the std dev in the placebo group at Visit 5|||||0.07
72535997|NCT00965562|144601640|SUPERIORITY_OR_OTHER||Cohen's d effect size|0.1||||0.94|TWO_SIDED||||||Mixed Models Analysis||Cohen's d effect sizes were calculated by subtracting the difference between changes in the calcium group between visits 1 and 5 and changes in the placebo group between Visits 1 and 5, divided by the std dev in the placebo group at Visit 5|||||0.94
72408643|NCT01416194|144325883|SUPERIORITY||Hazard Ratio (HR)|1.1||||0.59|TWO_SIDED|95.0|0.8|1.6|||Regression, Linear|||The hazard ratio from Cox proportional hazard regression models was used for comparison of event rates of the primary and secondary endpoints in each treatment group. Statistical two-sided tests was used with a significance level of 0.05.||1.6|0.8|0.59
72535998|NCT00965562|144601641|SUPERIORITY_OR_OTHER||Slope|-1.63||||0.1|TWO_SIDED|95.0|-3.6|0.34|||Mixed Models Analysis||Slope represents average change in fluoxetine group PMTS scores as compared to placebo|||0.34|-3.60|0.10
72535999|NCT00965562|144601641|SUPERIORITY_OR_OTHER||Slope|-0.81||||0.4|TWO_SIDED|95.0|-2.71|1.09|||Mixed Models Analysis||Slope represents average change in calcium group PMTS scores as compared to placebo|||1.09|-2.71|0.40
72536000|NCT00965562|144601641|SUPERIORITY_OR_OTHER||Cohen's d effect size|1.06||||0.1|TWO_SIDED||||||Mixed Models Analysis||Cohen's d effect sizes were calculated by subtracting the difference between changes in the fluoxetine group between visits 1 and 5 and changes in the placebo group between Visits 1 and 5, divided by the std dev in the placebo group at Visit 5|||||0.10
72536001|NCT00965562|144601641|SUPERIORITY_OR_OTHER||Cohen's d effect size|0.37||||0.4|TWO_SIDED||||||Mixed Models Analysis||Cohen's d effect sizes were calculated by subtracting the difference between changes in the calcium group between visits 1 and 5 and changes in the placebo group between Visits 1 and 5, divided by the std dev in the placebo group at Visit 5|||||0.40
72536002|NCT00965562|144601642|SUPERIORITY_OR_OTHER||Slope|-0.35||||0.07|TWO_SIDED|95.0|-0.73|0.03|||Mixed Models Analysis||Slope represents average change in fluoxetine group CGI-S scores as compared to placebo|||0.03|-0.73|0.07
72536003|NCT00965562|144601642|SUPERIORITY_OR_OTHER||Slope|-0.17||||0.36|TWO_SIDED|95.0|-0.54|0.2|||Mixed Models Analysis||Slope represents average change in calcium group CGI-S scores as compared to placebo|||0.20|-0.54|0.36
72536004|NCT00965562|144601642|SUPERIORITY_OR_OTHER||Cohen's d effect size|0.92||||0.07|TWO_SIDED||||||Mixed Models Analysis||Cohen's d effect sizes were calculated by subtracting the difference between changes in the fluoxetine group between visits 1 and 5 and changes in the placebo group between Visits 1 and 5, divided by the std dev in the placebo group at Visit 5|||||0.07
72536005|NCT00965562|144601642|SUPERIORITY_OR_OTHER||Cohen's d effect size|0.44||||0.36|TWO_SIDED||||||Mixed Models Analysis||Cohen's d effect sizes were calculated by subtracting the difference between changes in the calcium group between visits 1 and 5 and changes in the placebo group between Visits 1 and 5, divided by the std dev in the placebo group at Visit 5|||||0.36
72536006|NCT00965562|144601643|SUPERIORITY_OR_OTHER||Slope|-0.28||||0.02|TWO_SIDED|95.0|-0.53|-0.04|||Mixed Models Analysis||Slope represents average change in fluoxetine group DRSP scores as compared to placebo|||-0.04|-0.53|0.02
72408644|NCT01416194|144325884|SUPERIORITY||Hazard Ratio (HR)|0.8||||0.03|TWO_SIDED|95.0|0.6|1.0|||Regression, Logistic|||The hazard ratio from Cox proportional hazard regression models was used for comparison of event rates of the primary and secondary endpoints in each treatment group. Statistical two-sided tests was used with a significance level of 0.05.||1.0|0.6|0.03
72536007|NCT00965562|144601643|SUPERIORITY_OR_OTHER||Slope|0.06||||0.58|TWO_SIDED|95.0|-0.16|0.28|||Mixed Models Analysis||Slope represents average change in calcium group DRSP scores as compared to placebo|||0.28|-0.16|0.58
72536008|NCT00965562|144601643|SUPERIORITY_OR_OTHER||Cohen's d effect size|2.08||||0.02|TWO_SIDED||||||Mixed Models Analysis||Cohen's d effect sizes were calculated by subtracting the difference between changes in the fluoxetine group between visits 1 and 5 and changes in the placebo group between Visits 1 and 5, divided by the std dev in the placebo group at Visit 5|||||0.02
72536009|NCT00965562|144601643|SUPERIORITY_OR_OTHER||Cohen's d effect size|0.18||||0.58|TWO_SIDED||||||Mixed Models Analysis||Cohen's d effect sizes were calculated by subtracting the difference between changes in the calcium group between visits 1 and 5 and changes in the placebo group between Visits 1 and 5, divided by the std dev in the placebo group at Visit 5|||||0.58
72536010|NCT00965562|144601644|SUPERIORITY_OR_OTHER||Slope|-1.03||||0.04|TWO_SIDED|95.0|-1.7|-0.35|||Mixed Models Analysis||Slope represents average change in fluoxetine group CGI Improvement scores as compared to placebo|||-0.35|-1.70|0.04
72536011|NCT00965562|144601644|SUPERIORITY_OR_OTHER||Slope|-0.2||||0.54|TWO_SIDED|95.0|-0.86|0.46|||Mixed Models Analysis||Slope represents average change in calcium group CGI Improvement scores as compared to placebo|||0.46|-0.86|0.54
72536012|NCT00965562|144601644|SUPERIORITY_OR_OTHER||Cohen's d effect size|0.8||||0.04|TWO_SIDED||||||Mixed Models Analysis||Cohen's d effect sizes were calculated by subtracting the difference between changes in the fluoxetine group between visits 2 and 5 and changes in the placebo group between Visits 2 and 5, divided by the std dev in the placebo group at Visit 5|||||0.04
72536013|NCT00965562|144601644|SUPERIORITY_OR_OTHER||Cohen's d effect size|0.32||||0.54|TWO_SIDED||||||Mixed Models Analysis||Cohen's d effect sizes were calculated by subtracting the difference between changes in the calcium group between visits 2 and 5 and changes in the placebo group between Visits 2 and 5, divided by the std dev in the placebo group at Visit 5|||||0.54
72536014|NCT03179462|144601668|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<0.05
72536015|NCT04636437|144601669|SUPERIORITY||Mean Difference (Net)|1.36||||0.23|TWO_SIDED|97.5|-1.2|3.92||Bonferroni adjustment for 2 pairwise comparisons of DOR-containing arms versus continuation of INSTI. Two sided 2.5% alpha.|Regression, Linear||Mean difference and CI come from a linear regression model adjusting for entry weight, sex, and race (Black and not Black).|Null hypothesis: There is no difference between the two arms in percent change in body weight from entry to week 48.||3.92|-1.20|0.23
72536016|NCT04636437|144601669|SUPERIORITY||Mean Difference (Net)|-0.89||||0.41|TWO_SIDED|97.5|-3.34|1.57||Bonferroni adjustment for 2 pairwise comparisons of DOR-containing arms versus continuation of INSTI. Two sided 2.5% alpha.|Regression, Linear||Mean difference and CI come from a linear regression model adjusting for entry weight, sex, and race (Black and not Black).|Null hypothesis: There is no difference between the two arms in percent change in body weight from entry to week 48.||1.57|-3.34|0.41
72536017|NCT04636437|144601670|SUPERIORITY||Mean Difference (Net)|0.83||||0.31|TWO_SIDED|97.5|-0.99|2.64||Bonferroni adjustment for 2 pairwise comparisons of DOR-containing arms versus continuation of INSTI. Two sided 2.5% alpha.|Regression, Linear||Mean difference and CI come from a linear regression model adjusting for entry weight, sex, and race (Black and not Black).|Null hypothesis: There is no difference between the two arms in percent change in body weight from entry to week 24.||2.64|-0.99|0.31
72536018|NCT04636437|144601670|SUPERIORITY||Mean Difference (Net)|-1.99||||0.012|TWO_SIDED|97.5|-3.76|-0.21||Bonferroni adjustment for 2 pairwise comparisons of DOR-containing arms versus continuation of INSTI. Two sided 2.5% alpha.|Regression, Linear||Mean difference and CI come from a linear regression model adjusting for entry weight, sex, and race (Black and not Black).|Null hypothesis: There is no difference between the two arms in percent change in body weight from entry to week 24.||-0.21|-3.76|0.012
72536019|NCT04636437|144601671|SUPERIORITY||Mean Difference (Net)|1.72||||0.2|TWO_SIDED|97.5|-1.33|4.77||Bonferroni adjustment for 2 pairwise comparisons of DOR-containing arms versus continuation of INSTI. Two sided 2.5% alpha.|Regression, Linear||Mean difference and CI come from a linear regression model adjusting for entry waist circumference, sex, and race (Black and not Black).|Null hypothesis: There is no difference between the two arms in absolute change in waist circumference from entry to week 48.||4.77|-1.33|0.20
72536020|NCT04636437|144601671|SUPERIORITY||Mean Difference (Net)|-1.49||||0.25|TWO_SIDED|97.5|-4.43|1.44||Bonferroni adjustment for 2 pairwise comparisons of DOR-containing arms versus continuation of INSTI. Two sided 2.5% alpha.|Regression, Linear||Mean difference and CI come from a linear regression model adjusting for entry waist circumference, sex, and race (Black and not Black).|Null hypothesis: There is no difference between the two arms in absolute change in waist circumference from entry to week 48.||1.44|-4.43|0.25
72536021|NCT04636437|144601672|SUPERIORITY||Mean Difference (Net)|-0.16||||0.9|TWO_SIDED|97.5|-3.23|2.9||Bonferroni adjustment for 2 pairwise comparisons of DOR-containing arms versus continuation of INSTI. Two sided 2.5% alpha.|Regression, Linear||Mean difference and CI come from a linear regression model adjusting for entry waist circumference, sex, and race (Black and not Black).|Null hypothesis: There is no difference between the two arms in absolute change in waist circumference from entry to week 24.||2.90|-3.23|0.90
72536022|NCT04636437|144601672|SUPERIORITY||Mean Difference (Net)|-1.48||||0.26|TWO_SIDED|97.5|-4.47|1.51||Bonferroni adjustment for 2 pairwise comparisons of DOR-containing arms versus continuation of INSTI. Two sided 2.5% alpha.|Regression, Linear||Mean difference and CI come from a linear regression model adjusting for entry waist circumference, sex, and race (Black and not Black).|Null hypothesis: There is no difference between the two arms in absolute change in waist circumference from entry to week 24.||1.51|-4.47|0.26
72536023|NCT04636437|144601673|SUPERIORITY||Mean Difference (Net)|1.19||||0.91|TWO_SIDED|97.5|-22.2|24.59||Bonferroni adjustment for 2 pairwise comparisons of DOR-containing arms versus continuation of INSTI. Two sided 2.5% alpha.|Regression, Linear||Mean difference and CI come from a linear regression model adjusting for entry fasting triglycerides, sex, and race (Black and not Black).|Null hypothesis: There is no difference between the two arms in absolute change in fasting triglycerides from entry to week 48.||24.59|-22.2|0.91
72536024|NCT04636437|144601673|SUPERIORITY||Mean Difference (Net)|-7.1||||0.48|TWO_SIDED|97.5|-29.7|15.47||Bonferroni adjustment for 2 pairwise comparisons of DOR-containing arms versus continuation of INSTI. Two sided 2.5% alpha.|Regression, Linear||Mean difference and CI come from a linear regression model adjusting for entry fasting triglycerides, sex, and race (Black and not Black).|Null hypothesis: There is no difference between the two arms in absolute change in fasting triglycerides from entry to week 48.||15.47|-29.7|0.48
72536025|NCT04636437|144601674|SUPERIORITY||Mean Difference (Net)|-15.2||||0.3|TWO_SIDED|97.5|-48.6|18.2||Bonferroni adjustment for 2 pairwise comparisons of DOR-containing arms versus continuation of INSTI. Two sided 2.5% alpha.|Regression, Linear||Mean difference and CI come from a linear regression model adjusting for entry fasting triglycerides, sex, and race (Black and not Black).|Null hypothesis: There is no difference between the two arms in absolute change in fasting triglycerides from entry to week 24.||18.20|-48.6|0.30
72536026|NCT04636437|144601674|SUPERIORITY||Mean Difference (Net)|-18.5||||0.21|TWO_SIDED|97.5|-51.8|14.76||Bonferroni adjustment for 2 pairwise comparisons of DOR-containing arms versus continuation of INSTI. Two sided 2.5% alpha.|Regression, Linear||Mean difference and CI come from a linear regression model adjusting for entry fasting triglycerides, sex, and race (Black and not Black).|Null hypothesis: There is no difference between the two arms in absolute change in fasting triglycerides from entry to week 24.||14.76|-51.8|0.21
72408645|NCT01416194|144325884|SUPERIORITY||Hazard Ratio (HR)|0.8||||0.19|TWO_SIDED|95.0|0.6|1.1|||Regression, Linear|||The hazard ratio from Cox proportional hazard regression models was used for comparison of event rates of the primary and secondary endpoints in each treatment group. Statistical two-sided tests was used with a significance level of 0.05.||1.1|0.6|0.19
72536027|NCT04636437|144601675|SUPERIORITY||Mean Difference (Net)|-2.84||||0.58|TWO_SIDED|97.5|-14.4|8.72||Bonferroni adjustment for 2 pairwise comparisons of DOR-containing arms versus continuation of INSTI. Two sided 2.5% alpha.|Regression, Linear||Mean difference and CI come from a linear regression model adjusting for entry fasting LDL, sex, and race (Black and not Black).|Null hypothesis: There is no difference between the two arms in absolute change in fasting LDL from entry to week 48.||8.72|-14.4|0.58
72536028|NCT04636437|144601675|SUPERIORITY||Mean Difference (Net)|-6.88||||0.16|TWO_SIDED|97.5|-18.0|4.2||Bonferroni adjustment for 2 pairwise comparisons of DOR-containing arms versus continuation of INSTI. Two sided 2.5% alpha.|Regression, Linear||Mean difference and CI come from a linear regression model adjusting for entry fasting LDL, sex, and race (Black and not Black).|Null hypothesis: There is no difference between the two arms in absolute change in fasting LDL from entry to week 48.||4.20|-18.0|0.16
72573223|NCT03118570|144673101|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.092||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 6||||0.092
72536029|NCT04636437|144601676|SUPERIORITY||Mean Difference (Net)|-2.92||||0.47|TWO_SIDED|97.5|-12.1|6.27||Bonferroni adjustment for 2 pairwise comparisons of DOR-containing arms versus continuation of INSTI. Two sided 2.5% alpha.|Regression, Linear||Mean difference and CI come from a linear regression model adjusting for entry fasting LDL, sex, and race (Black and not Black).|Null hypothesis: There is no difference between the two arms in absolute change in fasting LDL from entry to week 24.||6.27|-12.1|0.47
72536030|NCT04636437|144601676|SUPERIORITY||Mean Difference (Net)|-15.1|||<|0.001|TWO_SIDED|97.5|-24.2|-5.91||Bonferroni adjustment for 2 pairwise comparisons of DOR-containing arms versus continuation of INSTI. Two sided 2.5% alpha.|Regression, Linear||Mean difference and CI come from a linear regression model adjusting for entry fasting LDL, sex, and race (Black and not Black).|Null hypothesis: There is no difference between the two arms in absolute change in fasting LDL from entry to week 24.||-5.91|-24.2|<0.001
72536031|NCT04636437|144601677|SUPERIORITY||Mean Difference (Net)|0.8||||0.79|TWO_SIDED|97.5|-6.17|7.77||Bonferroni adjustment for 2 pairwise comparisons of DOR-containing arms versus continuation of INSTI. Two sided 2.5% alpha.|Regression, Linear||Mean difference and CI come from a linear regression model adjusting for entry fasting HDL, sex, and race (Black and not Black).|Null hypothesis: There is no difference between the two arms in absolute change in fasting HDL from entry to week 48.||7.77|-6.17|0.79
72536032|NCT04636437|144601677|SUPERIORITY||Mean Difference (Net)|-5.46||||0.063|TWO_SIDED|97.5|-12.1|1.16||Bonferroni adjustment for 2 pairwise comparisons of DOR-containing arms versus continuation of INSTI. Two sided 2.5% alpha.|Regression, Linear||Mean difference and CI come from a linear regression model adjusting for entry fasting HDL, sex, and race (Black and not Black).|Null hypothesis: There is no difference between the two arms in absolute change in fasting HDL from entry to week 48.||1.16|-12.1|0.063
72536033|NCT04636437|144601678|SUPERIORITY||Mean Difference (Net)|-1.38||||0.27|TWO_SIDED|97.5|-4.21|1.45||Bonferroni adjustment for 2 pairwise comparisons of DOR-containing arms versus continuation of INSTI. Two sided 2.5% alpha.|Regression, Linear||Mean difference and CI come from a linear regression model adjusting for entry fasting HDL, sex, and race (Black and not Black).|Null hypothesis: There is no difference between the two arms in absolute change in fasting HDL from entry to week 24.||1.45|-4.21|0.27
72536034|NCT04636437|144601678|SUPERIORITY||Mean Difference (Net)|-5.45|||<|0.001|TWO_SIDED|97.5|-8.25|-2.66||Bonferroni adjustment for 2 pairwise comparisons of DOR-containing arms versus continuation of INSTI. Two sided 2.5% alpha.|Regression, Linear||Mean difference and CI come from a linear regression model adjusting for entry fasting HDL, sex, and race (Black and not Black).|Null hypothesis: There is no difference between the two arms in absolute change in fasting HDL from entry to week 24.||-2.66|-8.25|<0.001
72536035|NCT04636437|144601679|SUPERIORITY||Mean Difference (Net)|1.55||||0.77|TWO_SIDED|97.5|-10.3|13.44||Bonferroni adjustment for 2 pairwise comparisons of DOR-containing arms versus continuation of INSTI. Two sided 2.5% alpha.|Regression, Linear||Mean difference and CI come from a linear regression model adjusting for entry fasting glucose, sex, and race (Black and not Black).|Null hypothesis: There is no difference between the two arms in absolute change in fasting glucose from entry to week 48.||13.44|-10.3|0.77
72573224|NCT03118570|144673101|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.31||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 6||||0.310
72408646|NCT01416194|144325885|SUPERIORITY||Hazard Ratio (HR)|0.3|||<|0.01|TWO_SIDED|95.0|0.2|0.5|||Regression, Linear|||The hazard ratio from Cox proportional hazard regression models was used for comparison of event rates of the primary and secondary endpoints in each treatment group. Statistical two-sided tests was used with a significance level of 0.05.||0.5|0.2|<0.01
72408647|NCT01416194|144325885|SUPERIORITY||Hazard Ratio (HR)|0.6||||0.24|TWO_SIDED|95.0|0.3|1.3|||Regression, Linear|||The hazard ratio from Cox proportional hazard regression models was used for comparison of event rates of the primary and secondary endpoints in each treatment group. Statistical two-sided tests was used with a significance level of 0.05.||1.3|0.3|0.24
72536036|NCT04636437|144601679|SUPERIORITY||Mean Difference (Net)|-5.23||||0.3|TWO_SIDED|97.5|-16.7|6.2||Bonferroni adjustment for 2 pairwise comparisons of DOR-containing arms versus continuation of INSTI. Two sided 2.5% alpha.|Regression, Linear||Mean difference and CI come from a linear regression model adjusting for entry fasting glucose, sex, and race (Black and not Black).|Null hypothesis: There is no difference between the two arms in absolute change in fasting glucose from entry to week 48.||6.20|-16.7|0.30
72536037|NCT04636437|144601680|SUPERIORITY||Mean Difference (Net)|0.18||||0.96|TWO_SIDED|97.5|-8.78|9.15||Bonferroni adjustment for 2 pairwise comparisons of DOR-containing arms versus continuation of INSTI. Two sided 2.5% alpha.|Regression, Linear||Mean difference and CI come from a linear regression model adjusting for entry fasting glucose, sex, and race (Black and not Black).|Null hypothesis: There is no difference between the two arms in absolute change in fasting glucose from entry to week 24.||9.15|-8.78|0.96
72536038|NCT04636437|144601680|SUPERIORITY||Mean Difference (Net)|-6.32||||0.11|TWO_SIDED|97.5|-15.2|2.55||Bonferroni adjustment for 2 pairwise comparisons of DOR-containing arms versus continuation of INSTI. Two sided 2.5% alpha.|Regression, Linear||Mean difference and CI come from a linear regression model adjusting for entry fasting glucose, sex, and race (Black and not Black).|Null hypothesis: There is no difference between the two arms in absolute change in fasting glucose from entry to week 24.||2.55|-15.2|0.11
72536039|NCT04636437|144601681|SUPERIORITY||Mean Difference (Net)|8.07||||0.16|TWO_SIDED|97.5|-4.93|21.06||Bonferroni adjustment for 2 pairwise comparisons of DOR-containing arms versus continuation of INSTI. Two sided 2.5% alpha.|Regression, Linear||Mean difference and CI come from a linear regression model adjusting for entry fasting insulin, sex, and race (Black and not Black).|Null hypothesis: There is no difference between the two arms in absolute change in fasting insulin from entry to week 48.||21.06|-4.93|0.16
72573225|NCT03118570|144673101|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.304||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 6||||0.304
72573226|NCT03118570|144673101|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.155||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 12||||0.155
72536040|NCT04636437|144601681|SUPERIORITY||Mean Difference (Net)|8.89||||0.1|TWO_SIDED|97.5|-3.37|21.15||Bonferroni adjustment for 2 pairwise comparisons of DOR-containing arms versus continuation of INSTI. Two sided 2.5% alpha.|Regression, Linear||Mean difference and CI come from a linear regression model adjusting for entry fasting insulin, sex, and race (Black and not Black).|Null hypothesis: There is no difference between the two arms in absolute change in fasting insulin from entry to week 48.||21.15|-3.37|0.10
72536041|NCT04636437|144601682|SUPERIORITY||Mean Difference (Net)|4.28||||0.37|TWO_SIDED|97.5|-6.42|14.99||Bonferroni adjustment for 2 pairwise comparisons of DOR-containing arms versus continuation of INSTI. Two sided 2.5% alpha.|Regression, Linear||Mean difference and CI come from a linear regression model adjusting for entry fasting insulin, sex, and race (Black and not Black).|Null hypothesis: There is no difference between the two arms in absolute change in fasting insulin from entry to week 24.||14.99|-6.42|0.37
72536042|NCT04636437|144601682|SUPERIORITY||Mean Difference (Net)|0.37||||0.94|TWO_SIDED|97.5|-10.0|10.77||Bonferroni adjustment for 2 pairwise comparisons of DOR-containing arms versus continuation of INSTI. Two sided 2.5% alpha.|Regression, Linear||Mean difference and CI come from a linear regression model adjusting for entry fasting insulin, sex, and race (Black and not Black).|Null hypothesis: There is no difference between the two arms in absolute change in fasting insulin from entry to week 24.||10.77|-10.0|0.94
72536043|NCT04636437|144601683|SUPERIORITY||Mean Difference (Net)|2.77||||0.2|TWO_SIDED|97.5|-2.08|7.63||Bonferroni adjustment for 2 pairwise comparisons of DOR-containing arms versus continuation of INSTI. Two sided 2.5% alpha.|Regression, Linear||Mean difference and CI come from a linear regression model adjusting for entry HOMA-IR, sex, and race (Black and not Black).|Null hypothesis: There is no difference between the two arms in absolute change in HOMA-IR from entry to week 48.||7.63|-2.08|0.20
72536044|NCT04636437|144601683|SUPERIORITY||Mean Difference (Net)|2.21||||0.28|TWO_SIDED|97.5|-2.44|6.87||Bonferroni adjustment for 2 pairwise comparisons of DOR-containing arms versus continuation of INSTI. Two sided 2.5% alpha.|Regression, Linear||Mean difference and CI come from a linear regression model adjusting for entry HOMA-IR, sex, and race (Black and not Black).|Null hypothesis: There is no difference between the two arms in absolute change in HOMA-IR from entry to week 48.||6.87|-2.44|0.28
72536045|NCT04636437|144601684|SUPERIORITY||Mean Difference (Net)|1.79||||0.24|TWO_SIDED|97.5|-1.68|5.25||Bonferroni adjustment for 2 pairwise comparisons of DOR-containing arms versus continuation of INSTI. Two sided 2.5% alpha.|Regression, Linear||Mean difference and CI come from a linear regression model adjusting for entry HOMA-IR, sex, and race (Black and not Black).|Null hypothesis: There is no difference between the two arms in absolute change in HOMA-IR from entry to week 24.||5.25|-1.68|0.24
72536046|NCT04636437|144601684|SUPERIORITY||Mean Difference (Net)|-0.57||||0.7|TWO_SIDED|97.5|-3.91|2.78||Bonferroni adjustment for 2 pairwise comparisons of DOR-containing arms versus continuation of INSTI. Two sided 2.5% alpha.|Regression, Linear||Mean difference and CI come from a linear regression model adjusting for entry HOMA-IR, sex, and race (Black and not Black).|Null hypothesis: There is no difference between the two arms in absolute change in HOMA-IR from entry to week 24.||2.78|-3.91|0.70
72536047|NCT04636437|144601686|SUPERIORITY|||||||0.43||||||Bonferroni adjustment for 2 pairwise comparisons of DOR-containing arms versus continuation of INSTI. Two sided 2.5% alpha.|Fisher Exact|Fisher's Exact Mid P-Value||Null hypothesis: There is no difference between the two arms in occurrence of Grade ≥3 AEs from entry to week 48.||||0.43
72536048|NCT04636437|144601686|SUPERIORITY|||||||0.26||||||Bonferroni adjustment for 2 pairwise comparisons of DOR-containing arms versus continuation of INSTI. Two sided 2.5% alpha.|Fisher Exact|Fisher's Exact Mid P-Value||Null hypothesis: There is no difference between the two arms in occurrence of Grade ≥3 AEs from entry to week 48.||||0.26
72536049|NCT04636437|144601687|SUPERIORITY|||||||0.008||||||Bonferroni adjustment for 2 pairwise comparisons of DOR-containing arms versus continuation of INSTI. Two sided 2.5% alpha.|Fisher Exact|Fisher's Exact Mid P-Value||Null hypothesis: There is no difference between the two arms in occurrence of \>10% reduction in CrCl from entry to week 48.||||0.008
72536050|NCT04636437|144601687|SUPERIORITY|||||||0.068||||||Bonferroni adjustment for 2 pairwise comparisons of DOR-containing arms versus continuation of INSTI. Two sided 2.5% alpha.|Fisher Exact|Fisher's Exact Mid P-Value||Null hypothesis: There is no difference between the two arms in occurrence of \>10% reduction in CrCl from entry to week 48.||||0.068
72536051|NCT04636437|144601688|SUPERIORITY|||||||0.2||||||Bonferroni adjustment for 2 pairwise comparisons of DOR-containing arms versus continuation of INSTI. Two sided 2.5% alpha.|Fisher Exact|Fisher's Exact Mid P-Value||Null hypothesis: There is no difference between the two arms in occurrence of premature discontinuation of study treatment from entry to week 48.||||0.20
72536052|NCT04636437|144601688|SUPERIORITY|||||||0.56||||||Bonferroni adjustment for 2 pairwise comparisons of DOR-containing arms versus continuation of INSTI. Two sided 2.5% alpha.|Fisher Exact|Fisher's Exact Mid P-Value||Null hypothesis: There is no difference between the two arms in occurrence of premature discontinuation of study treatment from entry to week 48.||||0.56
72536053|NCT04636437|144601689|SUPERIORITY||Mean Difference (Net)|3.43||||0.13|TWO_SIDED|97.5|-1.62|8.47||Bonferroni adjustment for 2 pairwise comparisons of DOR-containing arms versus continuation of INSTI. Two sided 2.5% alpha.|Regression, Linear||Mean difference and CI come from a linear regression model adjusting for entry total fat, sex, and race (Black and not Black).|Null hypothesis: There is no difference between the two arms in percent change in total fat from entry to week 48.||8.47|-1.62|0.13
72536054|NCT04636437|144601689|SUPERIORITY||Mean Difference (Net)|-0.09||||0.97|TWO_SIDED|97.5|-4.89|4.72||Bonferroni adjustment for 2 pairwise comparisons of DOR-containing arms versus continuation of INSTI. Two sided 2.5% alpha.|Regression, Linear||Mean difference and CI come from a linear regression model adjusting for entry total fat, sex, and race (Black and not Black).|Null hypothesis: There is no difference between the two arms in percent change in total fat from entry to week 48.||4.72|-4.89|0.97
72536055|NCT04636437|144601690|SUPERIORITY||Mean Difference (Net)|0.31||||0.78|TWO_SIDED|97.5|-2.18|2.8||Bonferroni adjustment for 2 pairwise comparisons of DOR-containing arms versus continuation of INSTI. Two sided 2.5% alpha.|Regression, Linear||Mean difference and CI come from a linear regression model adjusting for entry lean mass, sex, and race (Black and not Black).|Null hypothesis: There is no difference between the two arms in percent change in lean mass from entry to week 48.||2.80|-2.18|0.78
72536056|NCT04636437|144601690|SUPERIORITY||Mean Difference (Net)|1.24||||0.23|TWO_SIDED|97.5|-1.11|3.59||Bonferroni adjustment for 2 pairwise comparisons of DOR-containing arms versus continuation of INSTI. Two sided 2.5% alpha.|Regression, Linear||Mean difference and CI come from a linear regression model adjusting for entry lean mass, sex, and race (Black and not Black).|Null hypothesis: There is no difference between the two arms in percent change in lean mass from entry to week 48.||3.59|-1.11|0.23
72536057|NCT04636437|144601691|SUPERIORITY||Mean Difference (Net)|3.71||||0.18|TWO_SIDED|97.5|-2.48|9.9||Bonferroni adjustment for 2 pairwise comparisons of DOR-containing arms versus continuation of INSTI. Two sided 2.5% alpha.|Regression, Linear||Mean difference and CI come from a linear regression model adjusting for entry trunk fat, sex, and race (Black and not Black).|Null hypothesis: There is no difference between the two arms in percent change in trunk fat from entry to week 48.||9.90|-2.48|0.18
72536058|NCT04636437|144601691|SUPERIORITY||Mean Difference (Net)|-1.35||||0.6|TWO_SIDED|97.5|-7.23|4.53||Bonferroni adjustment for 2 pairwise comparisons of DOR-containing arms versus continuation of INSTI. Two sided 2.5% alpha.|Regression, Linear||Mean difference and CI come from a linear regression model adjusting for entry trunk fat, sex, and race (Black and not Black).|Null hypothesis: There is no difference between the two arms in percent change in trunk fat from entry to week 48.||4.53|-7.23|0.60
72536059|NCT04636437|144601692|SUPERIORITY||Mean Difference (Net)|4.19||||0.094|TWO_SIDED|97.5|-1.45|9.83||Bonferroni adjustment for 2 pairwise comparisons of DOR-containing arms versus continuation of INSTI. Two sided 2.5% alpha.|Regression, Linear|||Null hypothesis: There is no difference between the two arms in percent change in limb fat from entry to week 48.|Mean difference and CI come from a linear regression model adjusting for entry limb fat, sex, and race (Black and not Black).|9.83|-1.45|0.094
72536060|NCT04636437|144601692|SUPERIORITY||Mean Difference (Net)|1.76||||0.46|TWO_SIDED|97.5|-3.59|7.11||Bonferroni adjustment for 2 pairwise comparisons of DOR-containing arms versus continuation of INSTI. Two sided 2.5% alpha.|Regression, Linear|||Null hypothesis: There is no difference between the two arms in percent change in limb fat from entry to week 48.|Mean difference and CI come from a linear regression model adjusting for entry limb fat, sex, and race (Black and not Black).|7.11|-3.59|0.46
72536061|NCT04636437|144601693|SUPERIORITY||Mean Difference (Net)|2.19||||0.26|TWO_SIDED|97.5|-2.19|6.56||Bonferroni adjustment for 2 pairwise comparisons of DOR-containing arms versus continuation of INSTI. Two sided 2.5% alpha.|Regression, Linear||Mean difference and CI come from a linear regression model adjusting for entry appendicular lean mass, sex, and race (Black and not Black).|Null hypothesis: There is no difference between the two arms in percent change in appendicular lean mass from entry to week 48.||6.56|-2.19|0.26
72536062|NCT04636437|144601693|SUPERIORITY||Mean Difference (Net)|3.15||||0.084|TWO_SIDED|97.5|-0.96|7.25||Bonferroni adjustment for 2 pairwise comparisons of DOR-containing arms versus continuation of INSTI. Two sided 2.5% alpha.|Regression, Linear||Mean difference and CI come from a linear regression model adjusting for entry appendicular lean mass, sex, and race (Black and not Black).|Null hypothesis: There is no difference between the two arms in percent change in appendicular lean mass from entry to week 48.||7.25|-0.96|0.084
72536063|NCT04636437|144601694|SUPERIORITY||Mean Difference (Net)|0.78||||0.19|TWO_SIDED|97.5|-0.57|2.13||Bonferroni adjustment for 2 pairwise comparisons of DOR-containing arms versus continuation of INSTI. Two sided 2.5% alpha.|Regression, Linear||Mean difference and CI come from a linear regression model adjusting for entry hip bone mineral density, sex, and race (Black and not Black).|Null hypothesis: There is no difference between the two arms in percent change in hip bone mineral density from entry to week 48.||2.13|-0.57|0.19
72536064|NCT04636437|144601694|SUPERIORITY||Mean Difference (Net)|-0.64||||0.27|TWO_SIDED|97.5|-1.93|0.66||Bonferroni adjustment for 2 pairwise comparisons of DOR-containing arms versus continuation of INSTI. Two sided 2.5% alpha.|Regression, Linear||Mean difference and CI come from a linear regression model adjusting for entry hip bone mineral density, sex, and race (Black and not Black).|Null hypothesis: There is no difference between the two arms in percent change in hip bone mineral density from entry to week 48.||0.66|-1.93|0.27
72536065|NCT04636437|144601695|SUPERIORITY||Mean Difference (Net)|0.5||||0.58|TWO_SIDED|97.5|-1.57|2.58||Bonferroni adjustment for 2 pairwise comparisons of DOR-containing arms versus continuation of INSTI. Two sided 2.5% alpha.|Regression, Linear||Mean difference and CI come from a linear regression model adjusting for entry lumbar spine bone mineral density, sex, and race (Black and not Black).|Null hypothesis: There is no difference between the two arms in percent change in lumbar spine bone mineral density from entry to week 48.||2.58|-1.57|0.58
72536066|NCT04636437|144601695|SUPERIORITY||Mean Difference (Net)|0.05||||0.95|TWO_SIDED|97.5|-1.93|2.03||Bonferroni adjustment for 2 pairwise comparisons of DOR-containing arms versus continuation of INSTI. Two sided 2.5% alpha.|Regression, Linear||Mean difference and CI come from a linear regression model adjusting for entry lumbar spine bone mineral density, sex, and race (Black and not Black).|Null hypothesis: There is no difference between the two arms in percent change in lumbar spine bone mineral density from entry to week 48.||2.03|-1.93|0.95
72536067|NCT01233284|144601698|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.138|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001||95.0|0.09|0.186|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R1.25 qd minus Placebo|||0.186|0.090|<0.0001
72536068|NCT01233284|144601698|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.128|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001||95.0|0.08|0.176|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R2.5 qd minus Placebo|||0.176|0.080|<0.0001
72536069|NCT01233284|144601698|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.188|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001||95.0|0.14|0.236|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R5 qd minus Placebo|||0.236|0.140|<0.0001
72536070|NCT01233284|144601699|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.125|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001||95.0|0.078|0.173|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R1.25 qd minus Placebo|||0.173|0.078|<0.0001
72536071|NCT01233284|144601699|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.132|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001||95.0|0.084|0.179|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R2.5 qd minus Placebo|||0.179|0.084|<0.0001
72408648|NCT01222494|144325886|SUPERIORITY|||||||0.01||||||The p-value refers to the treatment group term in the model. The a priori threshold for statistical significance in this planned primary test was p \< 0.05.|ANCOVA|||An ANCOVA was used to test for differences between groups at endpoint, controlling for baseline values.||||0.01
72626612|NCT02410772|144782207|NON_INFERIORITY|Non-inferiority was assessed using the upper bound of the two-sided 95% CI for the difference between the percentage of patients who are classified as having an unfavorable status on the control regimen (2HRZE/ 4 HR) and the investigational regimens, Regimen 2 (2HPZ/2HP) and Regimen 3 (2HPZM/2HPM). If the upper bound of the confidence interval is less than , then the non-inferiority of Arm 2 or Arm 3 to Arm 1 with a significance level of 0.05 is established (equivalent to one-sided α=0.025).|Risk Difference (RD)|1.0||||0.05|TWO_SIDED|95.0|-2.6|4.5||For a significance level of 0.05, the statistical test is equivalent to obtaining the two-sided 95% confidence interval for the difference of r\_b-r\_a.|Cochran-Mantel-Haenszel|||For primary efficacy endpoint, unfavorable outcomes for Arm1(control) vs Arm3(2PHZM/2PHM) will be considered first, if non-inferiority criteria are met, then Arm 1 vs Arm 2(2PHZE/2PH) will be compared. The proportion of participants with unfavorable outcome can be estimated as: if r\_a and r\_b are the proportions of unfavorable outcome for the two study arms (a=Arm1 and b = Arm2 or Arm3) and if δ is the non-inferiority margin (=6.6%), statistical hypothesis is H\_0:r\_b-r\_a≥δ vs.H\_1:r\_b-r\_a\<δ||4.5|-2.6|0.05
72408649|NCT01222494|144325887|SUPERIORITY|||||||0.04||||||The p-value refers to the treatment group term in the model. The a priori threshold for statistical significance in this planned primary test was p \< 0.05.|ANCOVA|||An ANCOVA was used to test for differences between groups at endpoint, controlling for baseline values.||||0.04
72626613|NCT02410772|144782207|NON_INFERIORITY|Non-inferiority was assessed using the upper bound of the two-sided 95% CI for the difference between the percentage of patients who are classified as having an unfavorable status on the control regimen (2HRZE/ 4 HR) and the investigational regimens, Regimen 2 (2HPZ/2HP) and Regimen 3 (2HPZM/2HPM). If the upper bound of the confidence interval is less than , then the non-inferiority of Arm 2 or Arm 3 to Arm 1 with a significance level of 0.05 is established (equivalent to one-sided α=0.025).|Risk Difference (RD)|3.0||||0.05|TWO_SIDED|95.0|-0.6|6.6|||Cochran-Mantel-Haenszel|For a significance level of 0.05, the statistical test is equivalent to obtaining the two-sided 95% confidence interval for the difference of r\_b-r\_a.||For primary efficacy endpoint, unfavorable outcomes for Arm1(control) vs Arm3(2PHZM/2PHM) will be considered first, if non-inferiority criteria are met, then Arm 1 vs Arm 2(2PHZE/2PH) will be compared. The proportion of participants with unfavorable outcome can be estimated as: if r\_a and r\_b are the proportions of unfavorable outcome for the two study arms (a=Arm1 and b = Arm2 or Arm3) and if δ is the non-inferiority margin (=6.6%), statistical hypothesis is H\_0:r\_b-r\_a≥δ vs.H\_1:r\_b-r\_a\<δ||6.6|-0.6|0.05
72626614|NCT02410772|144782208|NON_INFERIORITY|Non-inferiority was assessed using the upper bound of the two-sided 95% CI for the difference between the percentage of patients who are classified as having an unfavorable status on the control regimen (2HRZE/ 4 HR) and the investigational regimens, Regimen 2 (2HPZ/2HP) and Regimen 3 (2HPZM/2HPM). If the upper bound of the confidence interval is less than , then the non-inferiority of Arm 2 or Arm 3 to Arm 1 with a significance level of 0.05 is established (equivalent to one-sided α=0.025).|Risk Difference (RD)|2.0||||0.05|TWO_SIDED|95.0|-1.1|5.1||For a significance level of 0.05, the statistical test is equivalent to obtaining the two-sided 95% confidence interval for the difference of r\_b-r\_a|Cochran-Mantel-Haenszel|||For primary efficacy endpoint, unfavorable outcomes for Arm1(control) vs Arm3(2PHZM/2PHM) will be considered first, if non-inferiority criteria are met, then Arm 1 vs Arm 2(2PHZE/2PH) will be compared. The proportion of participants with unfavorable outcome can be estimated as: if r\_a and r\_b are the proportions of unfavorable outcome for the two study arms (a=Arm1 and b = Arm2 or Arm3) and if δ is the non-inferiority margin (=6.6%), statistical hypothesis is H\_0:r\_b-r\_a≥δ vs.H\_1:r\_b-r\_a\<δ||5.1|-1.1|0.05
72626615|NCT02410772|144782208|NON_INFERIORITY|Non-inferiority was assessed using the upper bound of the two-sided 95% CI for the difference between the percentage of patients who are classified as having an unfavorable status on the control regimen (2HRZE/ 4 HR) and the investigational regimens, Regimen 2 (2HPZ/2HP) and Regimen 3 (2HPZM/2HPM). If the upper bound of the confidence interval is less than , then the non-inferiority of Arm 2 or Arm 3 to Arm 1 with a significance level of 0.05 is established (equivalent to one-sided α=0.025).|Risk Difference (RD)|4.4||||0.05|TWO_SIDED|95.0|1.2|7.7||For a significance level of 0.05, the statistical test is equivalent to obtaining the two-sided 95% confidence interval for the difference of r\_b-r\_a|Cochran-Mantel-Haenszel|||For primary efficacy endpoint, unfavorable outcomes for Arm1(control) vs Arm3(2PHZM/2PHM) will be considered first, if non-inferiority criteria are met, then Arm 1 vs Arm 2(2PHZE/2PH) will be compared. The proportion of participants with unfavorable outcome can be estimated as: if r\_a and r\_b are the proportions of unfavorable outcome for the two study arms (a=Arm1 and b = Arm2 or Arm3) and if δ is the non-inferiority margin (=6.6%), statistical hypothesis is H\_0:r\_b-r\_a≥δ vs.H\_1:r\_b-r\_a\<δ||7.7|1.2|0.05
72626616|NCT02410772|144782209|NON_INFERIORITY|Non-inferiority was assessed using the upper bound of the two-sided 95% CI for the difference between the percentage of patients who are classified as having an unfavorable status on the control regimen (2HRZE/ 4 HR) and the investigational regimens, Regimen 2 (2HPZ/2HP) and Regimen 3 (2HPZM/2HPM). If the upper bound of the confidence interval is less than, then the non-inferiority of Arm 2 or Arm 3 to Arm 1 with a significance level of 0.05 is established (equivalent to one-sided α=0.025).|Risk Difference (RD)|-0.6||||0.05|TWO_SIDED|95.0|-4.3|3.2||For a significance level of 0.05, the statistical test is equivalent to obtaining the two-sided 95% confidence interval for the difference of r\_b-r\_a.|Cochran-Mantel-Haenszel|||For primary Safety endpoint, unfavorable outcomes for Arm1(control) vs Arm3(2PHZM/2PHM) will be considered first, if non-inferiority criteria are met, then Arm 1 vs Arm 2(2PHZE/2PH) will be compared. The proportion of participants with unfavorable outcome can be estimated as: if r\_a and r\_b are the proportions of unfavorable outcome for the two study arms (a=Arm1 and b = Arm2 or Arm3) and if δ is the non-inferiority margin (=6.6%), statistical hypothesis is H\_0:r\_b-r\_a≥δ vs.H\_1:r\_b-r\_a\<δ||3.2|-4.3|0.05
72408650|NCT01222494|144325888|SUPERIORITY|||||||0.7||||||The p-value refers to the treatment group term in the model. The a priori threshold for statistical significance in this planned primary test was p \< 0.05.|ANCOVA|||An ANCOVA was used to test for differences between groups at endpoint, controlling for baseline values.||||0.70
72408651|NCT01222494|144325889|SUPERIORITY|||||||0.003||||||The p-value refers to the treatment group term in the model. The a priori threshold for statistical significance in this planned primary test was p \< 0.05.|ANCOVA|||An ANCOVA was used to test for differences between groups at endpoint, controlling for baseline values.||||0.003
72408652|NCT02732847|144325920|OTHER|Chi square tests used to compared groups||||||0.924||||||A p-value of \< 0.05 was considered|Chi-squared|||||||0.924
72408653|NCT04574362|144325923|SUPERIORITY||Risk Difference (RD)|9.2|||<|0.0001|TWO_SIDED|95.0|5.4|13.0|||Cochran-Mantel-Haenszel||Risk difference and associated 95 percent (%) confidence interval (CI) were calculated from Mantel-Haenszel test, stratified by use of prophylactic medication and country. The risk difference was tested at a two-sided alpha level of 0.05.|||13.0|5.4|<0.0001
72408654|NCT04574362|144325924|SUPERIORITY||Risk Difference (RD)|14.8|||<|0.0001|TWO_SIDED|95.0|9.6|20.0|||Cochran-Mantel-Haenszel||Risk difference and associated 95% CI were calculated from Mantel-Haenszel test, stratified by use of prophylactic medication and country. The risk difference was tested at a two-sided alpha level of 0.05.|||20.0|9.6|<0.0001
72408655|NCT04574362|144325925|SUPERIORITY||Risk Difference (RD)|18.1|||<|0.0001|TWO_SIDED|95.0|13.0|23.3|||Cochran-Mantel-Haenszel|Within the family of key secondary endpoints, multiplicity was controlled using the Hochberg procedure.|Risk difference and associated 95% CI were calculated from Mantel-Haenszel test, stratified by use of prophylactic medication and country. The risk difference was tested at a two-sided alpha level of 0.05.|||23.3|13.0|<0.0001
72408656|NCT04574362|144325926|SUPERIORITY||Risk Difference (RD)|16.9|||<|0.0001|TWO_SIDED|95.0|11.4|22.3|||Cochran-Mantel-Haenszel|Within the family of key secondary endpoints, multiplicity was controlled using the Hochberg procedure.|Risk difference and associated 95% CI were calculated from Mantel-Haenszel test, stratified by use of prophylactic medication and country. The risk difference was tested at a two-sided alpha level of 0.05.|||22.3|11.4|<0.0001
72536072|NCT01233284|144601699|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.143|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001||95.0|0.096|0.191|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R5 qd minus Placebo|||0.191|0.096|<0.0001
72408657|NCT04574362|144325927|SUPERIORITY||Risk Difference (RD)|-11.5|||<|0.0001|TWO_SIDED|95.0|-15.0|-8.0|||Cochran-Mantel-Haenszel|Within the family of key secondary endpoints, multiplicity was controlled using the Hochberg procedure.|Risk difference and associated 95% CI were calculated from Mantel-Haenszel test, stratified by use of prophylactic medication and country. The risk difference was tested at a two-sided alpha level of 0.05.|||-8.0|-15.0|<0.0001
72408658|NCT04574362|144325928|SUPERIORITY||Risk Difference (RD)|7.7|||<|0.0001|TWO_SIDED|95.0|4.3|11.2|||Cochran-Mantel-Haenszel|Within the family of key secondary endpoints, multiplicity was controlled using the Hochberg procedure.|Risk differences and associated 95% CI were calculated from Mantel-Haenszel test, stratified by use of prophylactic medication and country. The risk difference was tested at a two-sided alpha level of 0.05.|||11.2|4.3|<0.0001
72408659|NCT04574362|144325929|SUPERIORITY||Risk difference|7.7|||<|0.0001|TWO_SIDED|95.0|4.4|11.0|||Cochran-Mantel-Haenszel|Within the family of key secondary endpoints, multiplicity was controlled using the Hochberg procedure.|Risk difference and associated 95% CI were calculated from Mantel-Haenszel test, stratified by use of prophylactic medication and country. The risk difference was tested at a two-sided alpha level of 0.05.|||11.0|4.4|<0.0001
72408660|NCT04574362|144325930|SUPERIORITY||Risk difference|-0.7||||0.2057|TWO_SIDED|95.0|-1.9|0.4||Nominal p-value|Cochran-Mantel-Haenszel||Risk difference and associated 95% CI were calculated from Mantel-Haenszel test, stratified by use of prophylactic medication and country. The risk difference was tested at a two-sided alpha level of 0.05.|15 minutes post-dose||0.4|-1.9|0.2057
72408661|NCT04574362|144325930|SUPERIORITY||Risk Difference (RD)|0.0||||0.9702|TWO_SIDED|95.0|-1.1|1.1||Nominal p-value|Cochran-Mantel-Haenszel||Risk difference and associated 95% CI were calculated from Mantel-Haenszel test, stratified by use of prophylactic medication and country. The risk difference was tested at a two-sided alpha level of 0.05.|30 minutes post-dose||1.1|-1.1|0.9702
72408662|NCT04574362|144325930|SUPERIORITY||Risk Difference (RD)|1.0||||0.2419|TWO_SIDED|95.0|-0.7|2.8||Nominal p-value|Cochran-Mantel-Haenszel||Risk difference and associated 95% CI were calculated from Mantel-Haenszel test, stratified by use of prophylactic medication and country. The risk difference was tested at a two-sided alpha level of 0.05.|45 minutes post-dose||2.8|-0.7|0.2419
72408663|NCT04574362|144325930|SUPERIORITY||Risk Difference (RD)|2.4||||0.0597|TWO_SIDED|95.0|-0.1|4.8||Nominal p-value|Cochran-Mantel-Haenszel||Risk difference and associated 95% CI were calculated from Mantel-Haenszel test, stratified by use of prophylactic medication and country. The risk difference was tested at a two-sided alpha level of 0.05.|60 minutes post-dose||4.8|-0.1|0.0597
72408664|NCT04574362|144325930|SUPERIORITY||Risk Difference (RD)|5.2||||0.0012|TWO_SIDED|95.0|2.1|8.4||Nominal p-value|Cochran-Mantel-Haenszel||Risk difference and associated 95% CI were calculated from Mantel-Haenszel test, stratified by use of prophylactic medication and country. The risk difference was tested at a two-sided alpha level of 0.05.|90 minutes post-dose||8.4|2.1|0.0012
72408665|NCT04574362|144325931|SUPERIORITY||Risk Difference (RD)|-0.7||||0.6809|TWO_SIDED|95.0|-3.9|2.5||Nominal p-value|Cochran-Mantel-Haenszel||Risk difference and associated 95% CI were calculated from Mantel-Haenszel test, stratified by use of prophylactic medication and country. The risk difference was tested at a two-sided alpha level of 0.05.|15 minutes post-dose||2.5|-3.9|0.6809
72536073|NCT01233284|144601700|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.129|STANDARD_ERROR_OF_MEAN|0.023|<|0.0001||95.0|0.083|0.175|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R1.25 qd minus Placebo|||0.175|0.083|<0.0001
72536074|NCT01233284|144601700|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.127|STANDARD_ERROR_OF_MEAN|0.023|<|0.0001||95.0|0.081|0.172|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R2.5 qd minus Placebo|||0.172|0.081|<0.0001
72536075|NCT01233284|144601700|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.178|STANDARD_ERROR_OF_MEAN|0.023|<|0.0001||95.0|0.132|0.224|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R5 qd minus Placebo|||0.224|0.132|<0.0001
72408666|NCT04574362|144325931|SUPERIORITY||Risk Difference (RD)|2.2||||0.2586|TWO_SIDED|95.0|-1.6|6.0||Nominal p-value|Cochran-Mantel-Haenszel||Risk difference and associated 95% CI were calculated from Mantel-Haenszel test, stratified by use of prophylactic medication and country. The risk difference was tested at a two-sided alpha level of 0.05.|30 minutes post-dose||6.0|-1.6|0.2586
72408667|NCT04574362|144325931|SUPERIORITY||Risk Difference (RD)|4.5||||0.0421|TWO_SIDED|95.0|0.2|8.8||Nominal p-value|Cochran-Mantel-Haenszel||Risk difference and associated 95% CI were calculated from Mantel-Haenszel test, stratified by use of prophylactic medication and country. The risk difference was tested at a two-sided alpha level of 0.05.|45 minutes post-dose||8.8|0.2|0.0421
72408668|NCT04574362|144325931|SUPERIORITY||Risk Difference (RD)|6.6||||0.0066|TWO_SIDED|95.0|1.8|11.3||Nominal p-value|Cochran-Mantel-Haenszel||Risk difference and associated 95% CI were calculated from Mantel-Haenszel test, stratified by use of prophylactic medication and country. The risk difference was tested at a two-sided alpha level of 0.05.|60 minutes post-dose||11.3|1.8|0.0066
72408669|NCT04574362|144325931|SUPERIORITY||Risk Difference (RD)|9.9||||0.0002|TWO_SIDED|95.0|4.8|14.9||Nominal p-value|Cochran-Mantel-Haenszel||Risk difference and associated 95% CI were calculated from Mantel-Haenszel test, stratified by use of prophylactic medication and country. The risk difference was tested at a two-sided alpha level of 0.05.|90 minutes post-dose||14.9|4.8|0.0002
72408670|NCT04574362|144325932|SUPERIORITY||Risk Difference (RD)|-10.4||||0.1148|TWO_SIDED|95.0|-23.5|2.8||Nominal p-value|Cochran-Mantel-Haenszel||Risk difference and associated 95% CI were calculated from Mantel-Haenszel test, stratified by use of prophylactic medication and country. The risk difference was tested at a two-sided alpha level of 0.05.|||2.8|-23.5|0.1148
72408671|NCT02002767|144325935|OTHER||Geometric Least Squares Mean(GLSM) Ratio|149.05|||||TWO_SIDED|90.0|116.62|190.49||||||A sample size of 8 evaluable participants in each renal function group (normal and severely impaired) will provide at least 80% power to reject the null hypothesis that participants with severe renal impairment have a minimum increase of 100% in AUC0-last, AUCinf, or Cmax of velpatasvir compared to participants with normal renal function.||190.49|116.62|
72408672|NCT02002767|144325936|OTHER||GLSM Ratio|149.9|||||TWO_SIDED|90.0|116.97|192.11||||||A sample size of 8 evaluable participants in each renal function group (normal and severely impaired) will provide at least 80% power to reject the null hypothesis that participants with severe renal impairment have a minimum increase of 100% in AUC0-last, AUCinf, or Cmax of velpatasvir compared to participants with normal renal function.||192.11|116.97|
72408673|NCT02002767|144325937|OTHER||GLSM Ratio|110.85|||||TWO_SIDED|90.0|90.76|135.38||||||A sample size of 8 evaluable participants in each renal function group (normal and severely impaired) will provide at least 80% power to reject the null hypothesis that participants with severe renal impairment have a minimum increase of 100% in AUC0-last, AUCinf, or Cmax of velpatasvir compared to participants with normal renal function.||135.38|90.76|
72408674|NCT00812929|144325941|SUPERIORITY||Mean Difference (Net)|1.29|STANDARD_ERROR_OF_MEAN|1.44|||TWO_SIDED|95.0|-1.56|4.13||||||||4.13|-1.56|
72408675|NCT00812929|144325941|SUPERIORITY||Mean Difference (Net)|0.53|STANDARD_ERROR_OF_MEAN|1.44|||TWO_SIDED|95.0|-2.32|3.37||||||||3.37|-2.32|
72408676|NCT00812929|144325941|SUPERIORITY||Mean Difference (Net)|0.33|STANDARD_ERROR_OF_MEAN|1.441|||TWO_SIDED|95.0|-2.52|3.18||||||||3.18|-2.52|
72408677|NCT00812929|144325941|SUPERIORITY||Mean Difference (Net)|2.53|STANDARD_ERROR_OF_MEAN|1.438|||TWO_SIDED|95.0|-0.31|5.37||||||||5.37|-0.31|
72408678|NCT00812929|144325942|SUPERIORITY||Mean Difference (Net)|2.52|STANDARD_ERROR_OF_MEAN|1.638|||TWO_SIDED|95.0|-0.72|5.75||||||2 Hours||5.75|-0.72|
72408679|NCT00812929|144325942|SUPERIORITY||Mean Difference (Net)|0.12|STANDARD_ERROR_OF_MEAN|1.247|||TWO_SIDED|95.0|-2.34|2.58||||||9.5 Hours||2.58|-2.34|
72408680|NCT00812929|144325942|SUPERIORITY||Mean Difference (Net)|2.6|STANDARD_ERROR_OF_MEAN|1.637|||TWO_SIDED|95.0|-0.64|5.84||||||2 Hours||5.84|-0.64|
72408681|NCT00812929|144325942|SUPERIORITY||Mean Difference (Net)|0.76|STANDARD_ERROR_OF_MEAN|1.247|||TWO_SIDED|95.0|-1.7|3.22||||||9.5 Hours||3.22|-1.70|
72536076|NCT01233284|144601701|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.079|STANDARD_ERROR_OF_MEAN|0.027||0.0034||95.0|0.026|0.132|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R1.25 qd minus Placebo|||0.132|0.026|0.0034
72536077|NCT01233284|144601701|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.071|STANDARD_ERROR_OF_MEAN|0.027||0.0087||95.0|0.018|0.124|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R2.5 qd minus Placebo|||0.124|0.018|0.0087
72408682|NCT00812929|144325942|SUPERIORITY||Mean Difference (Net)|2.79|STANDARD_ERROR_OF_MEAN|1.639|||TWO_SIDED|95.0|-0.45|6.03||||||2 Hours||6.03|-0.45|
72408683|NCT00812929|144325942|SUPERIORITY||Mean Difference (Net)|3.49|STANDARD_ERROR_OF_MEAN|1.248|||TWO_SIDED|95.0|1.02|5.95||||||9.5 Hours||5.95|1.02|
72536078|NCT01233284|144601701|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.137|STANDARD_ERROR_OF_MEAN|0.027|<|0.0001||95.0|0.085|0.19|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R5 qd minus Placebo|||0.190|0.085|<0.0001
72536079|NCT01233284|144601702|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.054|STANDARD_ERROR_OF_MEAN|0.03||0.0732||95.0|-0.005|0.113|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R1.25 qd minus Placebo|||0.113|-0.005|0.0732
72536080|NCT01233284|144601702|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.072|STANDARD_ERROR_OF_MEAN|0.03||0.0177||95.0|0.012|0.131|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R2.5 qd minus Placebo|||0.131|0.012|0.0177
72536081|NCT01233284|144601702|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.098|STANDARD_ERROR_OF_MEAN|0.03||0.0012||95.0|0.039|0.157|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R5 qd minus Placebo|||0.157|0.039|0.0012
72536082|NCT01233284|144601703|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.064|STANDARD_ERROR_OF_MEAN|0.026||0.0149||95.0|0.013|0.115|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R1.25 qd minus Placebo|||0.115|0.013|0.0149
72536083|NCT01233284|144601703|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.075|STANDARD_ERROR_OF_MEAN|0.026||0.0043||95.0|0.024|0.126|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R2.5 qd minus Placebo|||0.126|0.024|0.0043
72536084|NCT01233284|144601703|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.138|STANDARD_ERROR_OF_MEAN|0.026|<|0.0001||95.0|0.086|0.189|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R5 qd minus Placebo|||0.189|0.086|<0.0001
72408684|NCT00812929|144325942|SUPERIORITY||Mean Difference (Net)|6.3|STANDARD_ERROR_OF_MEAN|1.637|||TWO_SIDED|95.0|3.06|9.54||||||2 Hours||9.54|3.06|
72408685|NCT00812929|144325942|SUPERIORITY||Mean Difference (Net)|2.27|STANDARD_ERROR_OF_MEAN|1.245|||TWO_SIDED|95.0|-0.19|4.73||||||9.5 Hours||4.73|-0.19|
72408686|NCT00812929|144325943|SUPERIORITY||Mean Difference (Net)|0.94|STANDARD_ERROR_OF_MEAN|1.17|||TWO_SIDED|95.0|-1.37|3.25|||||Estimates and 95% confidence intervals for treatment difference between each active dose and placebo for each challenge time point were calculated.|2 Hours||3.25|-1.37|
72536085|NCT01233284|144601707|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|18.55|STANDARD_ERROR_OF_MEAN|3.737|<|0.0001||95.0|11.204|25.895|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R1.25 qd minus Placebo|||25.895|11.204|<0.0001
72536086|NCT01233284|144601707|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|17.895|STANDARD_ERROR_OF_MEAN|3.737|<|0.0001||95.0|10.55|25.24|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R2.5 qd minus Placebo|||25.240|10.550|<0.0001
72536087|NCT01233284|144601707|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|20.846|STANDARD_ERROR_OF_MEAN|3.739|<|0.0001||95.0|13.497|28.195|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R5 qd minus Placebo|||28.195|13.497|<0.0001
72536088|NCT01233284|144601708|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|21.251|STANDARD_ERROR_OF_MEAN|3.77|<|0.0001||95.0|13.84|28.662|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R1.25 qd minus Placebo|||28.662|13.840|<0.0001
72536089|NCT01233284|144601708|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.577|STANDARD_ERROR_OF_MEAN|3.77||0.0001||95.0|7.166|21.988|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R2.5 qd minus Placebo|||21.988|7.166|0.0001
72536090|NCT01233284|144601708|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|21.581|STANDARD_ERROR_OF_MEAN|3.773|<|0.0001||95.0|14.166|28.997|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R5 qd minus Placebo|||28.997|14.166|<0.0001
72536091|NCT01233284|144601709|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.114|STANDARD_ERROR_OF_MEAN|0.635||0.8574||95.0|-1.363|1.134|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R1.25 qd minus Placebo|||1.134|-1.363|0.8574
72536092|NCT01233284|144601709|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.54|STANDARD_ERROR_OF_MEAN|0.635||0.3954||95.0|-1.789|0.708|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R2.5 qd minus Placebo|||0.708|-1.789|0.3954
72536093|NCT01233284|144601709|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.077|STANDARD_ERROR_OF_MEAN|0.636||0.9034||95.0|-1.327|1.173|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R5 qd minus Placebo|||1.173|-1.327|0.9034
72536094|NCT01233284|144601710|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.233|STANDARD_ERROR_OF_MEAN|0.107||0.0296||95.0|-0.443|-0.023|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R1.25 qd minus Placebo|||-0.023|-0.443|0.0296
72536095|NCT01233284|144601710|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.214|STANDARD_ERROR_OF_MEAN|0.107||0.0454||95.0|-0.424|-0.004|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R2.5 qd minus Placebo|||-0.004|-0.424|0.0454
72536096|NCT01233284|144601710|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.201|STANDARD_ERROR_OF_MEAN|0.107||0.061||95.0|-0.41|0.009|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R5 qd minus Placebo|||0.009|-0.410|0.0610
72536097|NCT01233284|144601711|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.149|STANDARD_ERROR_OF_MEAN|0.063||0.0183||95.0|-0.273|-0.025|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R1.25 qd minus Placebo|||-0.025|-0.273|0.0183
72536098|NCT01233284|144601711|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.138|STANDARD_ERROR_OF_MEAN|0.063||0.0288||95.0|-0.262|-0.014|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R2.5 qd minus Placebo|||-0.014|-0.262|0.0288
72536099|NCT01233284|144601711|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.111|STANDARD_ERROR_OF_MEAN|0.063||0.0781||95.0|-0.235|0.013|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R5 qd minus Placebo|||0.013|-0.235|0.0781
72536100|NCT01233284|144601712|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.084|STANDARD_ERROR_OF_MEAN|0.055||0.1303||95.0|-0.193|0.025|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R1.25 qd minus Placebo|||0.025|-0.193|0.1303
72536101|NCT01233284|144601712|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.068|STANDARD_ERROR_OF_MEAN|0.055||0.2191||95.0|-0.177|0.041|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R2.5 qd minus Placebo|||0.041|-0.177|0.2191
72536102|NCT01233284|144601712|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.087|STANDARD_ERROR_OF_MEAN|0.056||0.1163||95.0|-0.196|0.022|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R5 qd minus Placebo|||0.022|-0.196|0.1163
72536103|NCT01233284|144601713|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.032||0.7501||95.0|-0.073|0.052|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R1.25 qd minus Placebo|||0.052|-0.073|0.7501
72408687|NCT00812929|144325943|SUPERIORITY||Mean Difference (Net)|0.07|STANDARD_ERROR_OF_MEAN|0.878|||TWO_SIDED|95.0|-1.66|1.8|||||Estimates and 95% confidence intervals for treatment difference between each active dose and placebo for each challenge time point were calculated.|9.5 Hours||1.80|-1.66|
72408688|NCT00812929|144325943|SUPERIORITY||Mean Difference (Net)|0.9|STANDARD_ERROR_OF_MEAN|0.873|||TWO_SIDED|95.0|-0.82|2.63|||||Estimates and 95% confidence intervals for treatment difference between each active dose and placebo for each challenge time point were calculated.|24 Hours||2.63|-0.82|
72408689|NCT00812929|144325943|SUPERIORITY||Mean Difference (Net)|1.12|STANDARD_ERROR_OF_MEAN|1.169|||TWO_SIDED|95.0|-1.19|3.43|||||Estimates and 95% confidence intervals for treatment difference between each active dose and placebo for each challenge time point were calculated.|2 Hours||3.43|-1.19|
72536104|NCT01233284|144601713|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.006|STANDARD_ERROR_OF_MEAN|0.032||0.8401||95.0|-0.069|0.056|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R2.5 qd minus Placebo|||0.056|-0.069|0.8401
72536105|NCT01233284|144601713|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.031|STANDARD_ERROR_OF_MEAN|0.032||0.3237||95.0|-0.094|0.031|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R5 qd minus Placebo|||0.031|-0.094|0.3237
72536106|NCT01233284|144601714|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.118|STANDARD_ERROR_OF_MEAN|0.079||0.1402|TWO_SIDED|95.0|-0.04|0.276||MMRM, adjusted for treatment, period, patient and study baseline.|Mixed Models Analysis||Tio R1.25 qd minus Placebo|Comparison vs. Placebo for AUC0-12h||0.276|-0.040|0.1402
72536107|NCT01233284|144601714|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.148|STANDARD_ERROR_OF_MEAN|0.079||0.0656|TWO_SIDED|95.0|-0.01|0.305|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R2.5 qd minus Placebo|Comparison vs. Placebo for AUC0-12h||0.305|-0.010|0.0656
72626617|NCT02410772|144782209|NON_INFERIORITY|Non-inferiority was assessed using the upper bound of the two-sided 95% CI for the difference between the percentage of patients who are classified as having an unfavorable status on the control regimen (2HRZE/ 4 HR) and the investigational regimens, Regimen 2 (2HPZ/2HP) and Regimen 3 (2HPZM/2HPM). If the upper bound of the confidence interval is less than, then the non-inferiority of Arm 2 or Arm 3 to Arm 1 with a significance level of 0.05 is established (equivalent to one-sided α=0.025).|Risk Difference (RD)|-5.1||||0.05|TWO_SIDED|95.0|-8.7|-1.5||For a significance level of 0.05, the statistical test is equivalent to obtaining the two-sided 95% confidence interval for the difference of r\_b-r\_a.|Cochran-Mantel-Haenszel|||For primary Safety endpoint, unfavorable outcomes for Arm1(control) vs Arm3(2PHZM/2PHM) will be considered first, if non-inferiority criteria are met, then Arm 1 vs Arm 2(2PHZE/2PH) will be compared. The proportion of participants with unfavorable outcome can be estimated as: if r\_a and r\_b are the proportions of unfavorable outcome for the two study arms (a=Arm1 and b = Arm2 or Arm3) and if δ is the non-inferiority margin (=6.6%), statistical hypothesis is H\_0:r\_b-r\_a≥δ vs.H\_1:r\_b-r\_a\<δ||-1.5|-8.7|0.05
72626618|NCT02410772|144782214|NON_INFERIORITY|Margin to define inferiority: 6.6% (δ = 0.066).|Risk Difference (RD)|1.09|||||TWO_SIDED|95.0|-2.45|4.63||||||||4.63|-2.45|
72536108|NCT01233284|144601714|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.142|STANDARD_ERROR_OF_MEAN|0.079||0.0766|TWO_SIDED|95.0|-0.015|0.299|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R5 qd minus Placebo|Comparison vs. Placebo for AUC0-12h||0.299|-0.015|0.0766
72536109|NCT01233284|144601714|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.081|STANDARD_ERROR_OF_MEAN|0.084||0.3371|TWO_SIDED|95.0|-0.086|0.249|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R1.25 qd minus Placebo|Comparison vs. Placebo for AUC12-24h||0.249|-0.086|0.3371
72536110|NCT01233284|144601714|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.136|STANDARD_ERROR_OF_MEAN|0.084||0.1097|TWO_SIDED|95.0|-0.031|0.303|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R2.5 qd minus Placebo|Comparison vs. Placebo for AUC12-24h||0.303|-0.031|0.1097
72536111|NCT01233284|144601714|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.196|STANDARD_ERROR_OF_MEAN|0.084||0.022|TWO_SIDED|95.0|0.029|0.363|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R5 qd minus Placebo|Comparison vs. Placebo for AUC12-24h||0.363|0.029|0.0220
72536112|NCT01233284|144601714|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.078||0.2062|TWO_SIDED|95.0|-0.056|0.256|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R1.25 qd minus Placebo|Comparison vs. Placebo for AUC0-24h||0.256|-0.056|0.2062
72536113|NCT01233284|144601714|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.142|STANDARD_ERROR_OF_MEAN|0.078||0.0731|TWO_SIDED|95.0|-0.014|0.297|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R2.5 qd minus Placebo|Comparison vs. Placebo for AUC0-24h||0.297|-0.014|0.0731
72536114|NCT01233284|144601714|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.169|STANDARD_ERROR_OF_MEAN|0.078||0.0333|TWO_SIDED|95.0|0.014|0.324|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R5 qd minus Placebo|Comparison vs. Placebo for AUC0-24h||0.324|0.014|0.0333
72536115|NCT01233284|144601715|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.116|STANDARD_ERROR_OF_MEAN|0.099||0.2451|TWO_SIDED|95.0|-0.081|0.312|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R1.25 qd minus Placebo|Comparison vs. Placebo for AUC0-12h||0.312|-0.081|0.2451
72626619|NCT02410772|144782214|NON_INFERIORITY|Margin to define inferiority: 6.6% (δ = 0.066).|Risk Difference (RD)|4.12|||||TWO_SIDED|95.0|0.45|7.79||||||||7.79|0.45|
72626620|NCT02410772|144782215|NON_INFERIORITY|Margin to define inferiority: 6.6% (δ = 0.066).|Risk Difference (RD)|1.05|||||TWO_SIDED|95.0|-2.01|4.11||||||||4.11|-2.01|
72626621|NCT02410772|144782215|NON_INFERIORITY|Margin to define inferiority: 6.6% (δ = 0.066)|Risk Difference (RD)|3.66|||||TWO_SIDED|95.0|0.42|6.9||||||||6.90|0.42|
72626622|NCT02410772|144782217|NON_INFERIORITY|Margin to define inferiority: 6.6% (δ = 0.066).|Risk Difference (RD)|3.0|||||TWO_SIDED|95.0|-0.6|6.6||||||||6.6|-0.6|
72626623|NCT02410772|144782217|NON_INFERIORITY|Margin to define inferiority: 6.6% (δ = 0.066).|Risk Difference (RD)|2.29|||||TWO_SIDED|95.0|-1.12|5.7||||||||5.70|-1.12|
72626624|NCT02410772|144782218|NON_INFERIORITY|Margin to define inferiority: 6.6% (δ = 0.066).|Risk Difference (RD)|5.9|||||TWO_SIDED|95.0|2.8|8.9||||||||8.9|2.8|
72626625|NCT02410772|144782218|NON_INFERIORITY|Margin to define inferiority: 6.6% (δ = 0.066).|Risk Difference (RD)|3.4|||||TWO_SIDED|95.0|0.5|6.3||||||||6.3|0.5|
72626626|NCT00560417|144782234|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority margin was prespecified at 0.4%|Mean Difference (Final Values)|0.22|||||TWO_SIDED|95.0|0.06|0.38|||ANCOVA|Variable = Treatment + Baseline + Baseline HbA1c Group + Baseline SU Group.||||0.38|0.06|
72626627|NCT00560417|144782235|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.24||||0.003|TWO_SIDED|95.0|0.08|0.39||p-value is for 24 weeks.|ANCOVA|Variable = Treatment + Baseline + Baseline HbA1c Group + Baseline SU Group||||0.39|0.08|0.003
72626628|NCT00560417|144782235|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.22||||0.008|TWO_SIDED|95.0|0.06|0.38||p-value is for Endpoint (LOCF)|ANCOVA|Variable = Treatment + Baseline + Baseline HbA1c Group + Baseline SU Group||||0.38|0.06|0.008
72573227|NCT03118570|144673101|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.392||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 12||||0.392
72573228|NCT03118570|144673101|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.464||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 12||||0.464
72573229|NCT03118570|144673102|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.15||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 6||||0.150
72573230|NCT03118570|144673102|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.468||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 6||||0.468
72573231|NCT03118570|144673102|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.8||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 6||||0.800
72573232|NCT03118570|144673102|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.563||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 12||||0.563
72573233|NCT03118570|144673102|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.839||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 12||||0.839
72573234|NCT03118570|144673102|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.186||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 12||||0.186
72573235|NCT03118570|144673103|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.278||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 6||||0.278
72573236|NCT03118570|144673103|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.292||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 6||||0.292
72573237|NCT03118570|144673103|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.115||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 6||||0.115
72573238|NCT03118570|144673103|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.356||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 12||||0.356
72573239|NCT03118570|144673103|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.205||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 12||||0.205
72573240|NCT03118570|144673103|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.078||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 12||||0.078
72573241|NCT03118570|144673104|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.037||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 6||||0.037
72573242|NCT03118570|144673104|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.342||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 6||||0.342
72573243|NCT03118570|144673104|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.515||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 6||||0.515
72573244|NCT03118570|144673104|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.786||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 12||||0.786
72573245|NCT03118570|144673104|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.212||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 12||||0.212
72573246|NCT03118570|144673104|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.655||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 12||||0.655
72573247|NCT04568031|144673122|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||< 0.001
72573248|NCT04568031|144673122|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||< 0.001
72573249|NCT04568031|144673127|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||< 0.001
72573250|NCT04568031|144673127|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||< 0.001
72573251|NCT04568031|144673130|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||< 0.001
72626629|NCT00560417|144782236|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.24||||0.003|TWO_SIDED|95.0|0.08|0.39||p-value is for 24 Weeks change.|ANCOVA|Variable = Treatment + Baseline + Baseline HbA1c Group + Baseline SU Group||||0.39|0.08|0.003
72573252|NCT04568031|144673130|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||< 0.001
72573253|NCT04682730|144673162|SUPERIORITY||Odds Ratio (OR)|0.8|STANDARD_ERROR_OF_MEAN|0.13||0.18|TWO_SIDED|95.0|0.58|1.11|||Mixed Models Analysis|||||1.11|0.58|0.18
72626630|NCT00560417|144782236|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.22||||0.008|TWO_SIDED|95.0|0.06|0.38||p-value is for Endpoint (LOCF) Change.|ANCOVA|||||0.38|0.06|0.008
72536116|NCT01233284|144601715|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.209|STANDARD_ERROR_OF_MEAN|0.099||0.0379|TWO_SIDED|95.0|0.012|0.405|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R2.5 qd minus Placebo|Comparison vs. Placebo for AUC0-12h||0.405|0.012|0.0379
72626631|NCT00560417|144782237|SUPERIORITY_OR_OTHER|||||||0.561||95.0||||p-value is for Week 12: HbA1c \<7.0%|Fisher Exact|||||||0.561
72626632|NCT00560417|144782237|SUPERIORITY_OR_OTHER|||||||0.511||95.0||||p-value is for Week 12: HbA1c \<=6.5%|Fisher Exact|||||||0.511
72408690|NCT00812929|144325943|SUPERIORITY||Mean Difference (Net)|1.22|STANDARD_ERROR_OF_MEAN|0.878|||TWO_SIDED|95.0|-0.51|2.95|||||Estimates and 95% confidence intervals for treatment difference between each active dose and placebo for each challenge time point were calculated.|9.5 Hours||2.95|-0.51|
72408691|NCT00812929|144325943|SUPERIORITY||Mean Difference (Net)|0.18|STANDARD_ERROR_OF_MEAN|0.873|||TWO_SIDED|95.0|-1.55|1.9|||||Estimates and 95% confidence intervals for treatment difference between each active dose and placebo for each challenge time point were calculated.|24 Hours||1.90|-1.55|
72573254|NCT04682730|144673164|OTHER|single intervention group across 16 clinics|mean total program costs in 2021 dollars|7845.0|STANDARD_DEVIATION|2.0|||TWO_SIDED|95.0|6378.0|9312.0|||||An opportunity cost approach was used. Costs estimated: Develop workbook- guideline, EHR data analyses, survey, evidence review- \& print; facilitator training/delivery/program tailoring; staff time; implemented strategies; dental sealant placements.|Mean Total Program costs per clinic for the KPNW Dental system.||9312|6378|
72573255|NCT04682730|144673168|OTHER|single intervention group across 16 clinics|mean total costs/per clinic per sealant|1321.0|STANDARD_DEVIATION|1245.0|||TWO_SIDED|95.0|845.0|3208.0|||||Total cost per sealant calculated as quotient of total intervention costs ($125,521) \& total sealants placed (95), is = to mean cost/sealant across each clinic ($7845/5.938).|Mean Total Program costs per sealant per clinic for the KPNW Dental system.||3208|845|
72626633|NCT00560417|144782237|SUPERIORITY_OR_OTHER|||||||0.012||95.0||||p-value is for Week 18: HbA1c \<7.0%|Fisher Exact|||||||0.012
72626634|NCT00560417|144782237|SUPERIORITY_OR_OTHER|||||||0.269||95.0||||p-value is for Week 18: HbA1c \<=6.5%|Fisher Exact|||||||0.269
72626635|NCT00560417|144782237|SUPERIORITY_OR_OTHER|||||||0.161||95.0||||p-value is for Week 24: HbA1c \<7.0%|Fisher Exact|||||||0.161
72626636|NCT00560417|144782237|SUPERIORITY_OR_OTHER|||||||0.071||95.0||||p-value is for Week 24: HbA1c \<=6.5%|Fisher Exact|||||||0.071
72626637|NCT00560417|144782237|SUPERIORITY_OR_OTHER|||||||0.177||95.0||||p-value is for Endpoint (LOCF): HbA1c \<7.0%|Fisher Exact|||||||0.177
72408692|NCT00812929|144325943|SUPERIORITY||Mean Difference (Net)|1.51|STANDARD_ERROR_OF_MEAN|1.171|||TWO_SIDED|95.0|-0.8|3.82|||||Estimates and 95% confidence intervals for treatment difference between each active dose and placebo for each challenge time point were calculated.|2 Hours||3.82|-0.80|
72536117|NCT01233284|144601715|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.167|STANDARD_ERROR_OF_MEAN|0.099||0.0957|TWO_SIDED|95.0|-0.03|0.363|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R5 qd minus Placebo|Comparison vs. Placebo for AUC0-12h||0.363|-0.030|0.0957
72536118|NCT01233284|144601715|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.067|STANDARD_ERROR_OF_MEAN|0.104||0.5207|TWO_SIDED|95.0|-0.139|0.273|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R1.25 qd minus Placebo|Comparison vs. Placebo for AUC12-24h||0.273|-0.139|0.5207
72573256|NCT04682730|144673170|OTHER|descriptive analysis|percentage|100.0|||||TWO_SIDED||||||||||89/89 treatment plans completed by the end of the period.|||
72573257|NCT00786994|144673188|SUPERIORITY_OR_OTHER|||||||0.6|TWO_SIDED||||||Mantel Haenszel|||A vs C/D||||0.60
72573258|NCT00786994|144673188|SUPERIORITY_OR_OTHER|||||||0.83|TWO_SIDED||||||Mantel Haenszel|||B vs. C/D||||0.83
72573259|NCT03564444|144673189|SUPERIORITY||Risk Difference (RD)|0.0|||||TWO_SIDED|95.0|-6.7|1.9||||||||1.9|-6.7|
72573260|NCT01540773|144673195|SUPERIORITY|||||||0.01|||||||t-test, 2 sided|||||||0.01
72573261|NCT01540773|144673196|SUPERIORITY|||||||0.04|||||||t-test, 2 sided|||||||0.04
72626638|NCT00560417|144782237|SUPERIORITY_OR_OTHER|||||||0.06||95.0||||p-value is for Endpoint (LOCF): HbA1c \<=6.5%|Fisher Exact|||||||0.060
72626639|NCT00560417|144782238|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.28||||0.179|TWO_SIDED|95.0|-1.97|10.53||p-value is for Endpoint Morning Pre-Meal.|ANCOVA|Variable = Treatment + Baseline + Baseline HbA1c Group + Baseline SU Group||||10.53|-1.97|0.179
72626640|NCT00560417|144782238|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.96|||<|0.001|TWO_SIDED|95.0|5.72|22.19||p-value is for Endpoint Morning Postprandial.|ANCOVA|Variable = Treatment + Baseline + Baseline HbA1c Group + Baseline SU Group||||22.19|5.72|<0.001
72626641|NCT00560417|144782238|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.8||||0.325|TWO_SIDED|95.0|-3.79|11.39||p-value is for Endpoint Midday Pre-Meal.|ANCOVA|Variable = Treatment + Baseline + Baseline HbA1c Group + Baseline SU Group||||11.39|-3.79|0.325
72626642|NCT00560417|144782238|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.73||||0.051|TWO_SIDED|95.0|-0.04|17.5||p-value is for Endpoint Midday Postprandial.|ANCOVA|Variable = Treatment + Baseline + Baseline HbA1c Group + Baseline SU Group||||17.50|-0.04|0.051
72408693|NCT00812929|144325943|SUPERIORITY||Mean Difference (Net)|3.3|STANDARD_ERROR_OF_MEAN|0.879|||TWO_SIDED|95.0|1.57|5.03|||||Estimates and 95% confidence intervals for treatment difference between each active dose and placebo for each challenge time point were calculated.|9.5 Hours||5.03|1.57|
72408694|NCT00812929|144325943|SUPERIORITY||Mean Difference (Net)|-0.1|STANDARD_ERROR_OF_MEAN|0.874|||TWO_SIDED|95.0|-1.83|1.62|||||Estimates and 95% confidence intervals for treatment difference between each active dose and placebo for each challenge time point were calculated.|24 Hours||1.62|-1.83|
72408695|NCT00812929|144325943|SUPERIORITY||Mean Difference (Net)|3.17|STANDARD_ERROR_OF_MEAN|1.169|||TWO_SIDED|95.0|0.86|5.48|||||Estimates and 95% confidence intervals for treatment difference between each active dose and placebo for each challenge time point were calculated.|2 Hours||5.48|0.86|
72408696|NCT00812929|144325943|SUPERIORITY||Mean Difference (Net)|2.11|STANDARD_ERROR_OF_MEAN|0.877|||TWO_SIDED|95.0|0.38|3.84|||||Estimates and 95% confidence intervals for treatment difference between each active dose and placebo for each challenge time point were calculated.|9.5 Hours||3.84|0.38|
72408697|NCT00812929|144325943|SUPERIORITY||Mean Difference (Net)|1.72|STANDARD_ERROR_OF_MEAN|0.872|||TWO_SIDED|95.0|0.0|3.44|||||Estimates and 95% confidence intervals for treatment difference between each active dose and placebo for each challenge time point were calculated.|24 Hours||3.44|-0.00|
72408698|NCT00812929|144325944|SUPERIORITY||Hazard Ratio (HR)|1.25|||||TWO_SIDED|95.0|0.71|2.21|||||Hazard ratio = ratio of likelihood of recovery at any time on active treatment vs placebo|2 Hours||2.21|0.71|
72408699|NCT00812929|144325944|SUPERIORITY||Hazard Ratio (HR)|1.1|||||TWO_SIDED|95.0|0.59|2.06|||||Hazard ratio = ratio of likelihood of recovery at any time on active treatment vs placebo|9.5 Hours||2.06|0.59|
72536119|NCT01233284|144601715|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.198|STANDARD_ERROR_OF_MEAN|0.104||0.0606|TWO_SIDED|95.0|-0.009|0.404|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R2.5 qd minus Placebo|Comparison vs. Placebo for AUC12-24h||0.404|-0.009|0.0606
72536120|NCT01233284|144601715|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.181|STANDARD_ERROR_OF_MEAN|0.104||0.0855|TWO_SIDED|95.0|-0.026|0.387|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R5 qd minus Placebo|Comparison vs. Placebo for AUC12-24h||0.387|-0.026|0.0855
72573262|NCT03753763|144673199|SUPERIORITY||Least square mean difference|0.1||||0.9697|TWO_SIDED|95.0|-6.3|6.5|||Mixed Models Analysis|A mixed-model repeated measures (MMRM) was used to analyze the change in anterior and lateral displacement from baseline||The model included treatment, week of visit, and treatment-by-visit interaction as fixed effects and baseline score as a covariate.||6.5|-6.3|0.9697
72408700|NCT00812929|144325944|SUPERIORITY||Hazard Ratio (HR)|1.78|||||TWO_SIDED|95.0|0.93|3.43|||||Hazard ratio = ratio of likelihood of recovery at any time on active treatment vs placebo|24 Hours||3.43|0.93|
72408701|NCT00812929|144325944|SUPERIORITY||Hazard Ratio (HR)|1.42|||||TWO_SIDED|95.0|0.81|2.48|||||Hazard ratio = ratio of likelihood of recovery at any time on active treatment vs placebo|2 Hours||2.48|0.81|
72408702|NCT00812929|144325944|SUPERIORITY||Hazard Ratio (HR)|1.93|||||TWO_SIDED|95.0|1.01|3.66|||||Hazard ratio = ratio of likelihood of recovery at any time on active treatment vs placebo|9.5 Hours||3.66|1.01|
72408703|NCT00812929|144325944|SUPERIORITY||Hazard Ratio (HR)|1.67|||||TWO_SIDED|95.0|0.86|3.25|||||Hazard ratio = ratio of likelihood of recovery at any time on active treatment vs placebo|24 Hours||3.25|0.86|
72408704|NCT00812929|144325944|SUPERIORITY||Hazard Ratio (HR)|2.09|||||TWO_SIDED|95.0|1.19|3.69|||||Hazard ratio = ratio of likelihood of recovery at any time on active treatment vs placebo|2 Hours||3.69|1.19|
72536121|NCT01233284|144601715|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.091|STANDARD_ERROR_OF_MEAN|0.099||0.3564|TWO_SIDED|95.0|-0.104|0.287|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R1.25 qd minus Placebo|Comparison vs. Placebo for AUC0-24h||0.287|-0.104|0.3564
72536122|NCT01233284|144601715|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.203|STANDARD_ERROR_OF_MEAN|0.099||0.0424|TWO_SIDED|95.0|0.007|0.399|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R2.5 qd minus Placebo|Comparison vs. Placebo for AUC0-24h||0.399|0.007|0.0424
72536123|NCT01233284|144601715|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.174|STANDARD_ERROR_OF_MEAN|0.099||0.0815|TWO_SIDED|95.0|-0.022|0.37|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R5 qd minus Placebo|Comparison vs. Placebo for AUC0-24h||0.370|-0.022|0.0815
72536124|NCT01821391|144601744|SUPERIORITY||||||=|0.2665|||||||Paired Student's t test|||||||=0.2665
72536125|NCT04880850|144601806|NON_INFERIORITY|Non-inferiority of insulin icodec was considered confirmed if the upper limit of the two-sided 95% confidence interval (CI) for mean treatment difference (insulin icodec minus insulin glargine) was strictly below 0.3%.|Treatment difference|0.02|||<|0.0001|TWO_SIDED|95.0|-0.11|0.15|||ANCOVA|||The response and change from baseline in response after 26 weeks were analysed using an analysis of covariance (ANCOVA) model with treatment, region and personal continuous glucose monitoring (CGM) device use as fixed factors, and baseline response as covariate.||0.15|-0.11|<0.0001
72536126|NCT03417102|144601817|SUPERIORITY||ABR ratio|0.092|||<|0.0001|TWO_SIDED|95.0|0.044|0.192||P-value derived from NB regression model, accounted for different follow-up times during EP, with treatment arm and randomization strata of number of bleeds in 6 months prior to study (\<=10,\>10) as fixed effects. Significance threshold was 0.05.|Negative binomial regression model|||||0.192|0.044|<0.0001
72536127|NCT03417102|144601819|SUPERIORITY||ABR ratio|0.108|||<|0.0001|TWO_SIDED|95.0|0.056|0.207||P-value derived from NB regression model, accounted for different follow-up times during TP, with treatment arm and randomization strata of number of bleeds in 6 months prior to study (\<=10,\>10) as fixed effects. Significance threshold was 0.05.|Negative binomial regression model|||||0.207|0.056|<0.0001
72408705|NCT00812929|144325944|SUPERIORITY||Hazard Ratio (HR)|5.49|||||TWO_SIDED|95.0|2.75|10.94|||||Hazard ratio = ratio of likelihood of recovery at any time on active treatment vs placebo|9.5 Hours||10.94|2.75|
72408706|NCT00812929|144325944|SUPERIORITY||Hazard Ratio (HR)|1.91|||||TWO_SIDED|95.0|1.0|3.64|||||Hazard ratio = ratio of likelihood of recovery at any time on active treatment vs placebo|24 Hours||3.64|1.00|
72536128|NCT03417102|144601821|SUPERIORITY||ABR ratio|0.056|||<|0.0001|TWO_SIDED|95.0|0.026|0.121||P-value derived from NB regression model, accounted for different follow-up times during EP, with treatment arm and randomization strata of number of bleeds in 6 months prior to study (\<=10,\>10) as fixed effects. Significance threshold was 0.05.|Negative binomial regression model|||||0.121|0.026|<0.0001
72408707|NCT00812929|144325944|SUPERIORITY||Hazard Ratio (HR)|3.6|||||TWO_SIDED|95.0|2.0|6.48|||||Hazard ratio = ratio of likelihood of recovery at any time on active treatment vs placebo|2 Hours||6.48|2.00|
72408708|NCT00812929|144325944|SUPERIORITY||Hazard Ratio (HR)|2.03|||||TWO_SIDED|95.0|1.07|3.87|||||Hazard ratio = ratio of likelihood of recovery at any time on active treatment vs placebo|9.5 Hours||3.87|1.07|
72408709|NCT00812929|144325944|SUPERIORITY||Hazard Ratio (HR)|6.07|||||TWO_SIDED|95.0|2.9|12.71|||||Hazard ratio = ratio of likelihood of recovery at any time on active treatment vs placebo|24 Hours||12.71|2.90|
72408710|NCT02832674|144326008|SUPERIORITY|||||||0.05|TWO_SIDED|90.0|||||Fisher Exact|||The primary endpoint was an evaluation of the proportion of subjects with ≥ 20 mm2 lift at Day 90.||||0.05
72408711|NCT02832674|144326009|OTHER|Binomial test of proportions||||||0.025|TWO_SIDED|95.0|||||Chi-squared||||The summary included number and percentage of subjects in each of the categories and the 2 sided Clopper-Pearson 95% CI. a binomial test of proportions tested the improvement at Day 90 and Day 180.|||0.025
72408712|NCT02832674|144326010|OTHER|||||||0.025|TWO_SIDED|95.0|||||Chi-squared|||Analysis of all effectiveness endpoints was conducted on the ITT population and on the PP population.|The summary included number and percentage of subjects in each of the categories and the 2 sided Clopper-Pearson 95% CI. a binomial test of proportions tested the improvement at Day 90 and Day 180.|||0.025
72408713|NCT02832674|144326011|OTHER|||||||0.025|TWO_SIDED|95.0|||||Chi-squared||||The summary included number and percentage of subjects in each of the categories and the 2 sided Clopper-Pearson 95% CI. a binomial test of proportions tested the improvement at Day 90 and Day 180.|||0.025
72408714|NCT02832674|144326012|OTHER|||||||0.025|TWO_SIDED|95.0|||||Chi-squared||||The summary included number and percentage of subjects in each of the categories and the 2 sided Clopper-Pearson 95% CI. a binomial test of proportions tested the improvement at Day 90 and Day 180.|||0.025
72408715|NCT02832674|144326013|OTHER|||||||0.025|TWO_SIDED|95.0|||||Chi-squared||||The summary included number and percentage of subjects in each of the categories and the 2 sided Clopper-Pearson 95% CI. a binomial test of proportions tested the improvement at Day 90 and Day 180.|||0.025
72408716|NCT00678691|144326016|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0||||all p-values come from one model analysis and are therefore included in free text as such|piecewise model|A piecewise statistical model results for between group differences: P=.390 (baseline through week 5), p=.775 (week 5 - week 8||Authors expected armodafinal to work better than placebo reducing BFI scale scores by 30%. A piecewise statistical model was used to compare baseline scores against those over through week 8. Piecewise results for between group differences for BFI Scores: P=.390 (baseline through week 5), p=.775 (week 5 - week 8).||||<0.05
72536129|NCT03417102|144601823|SUPERIORITY||ABR ratio|0.098|||<|0.0001|TWO_SIDED|95.0|0.046|0.21||P-value derived from NB regression model, accounted for different follow-up times during EP, with treatment arm and randomization strata of number of bleeds in 6 months prior to study (\<=10,\>10) as fixed effects. Significance threshold was 0.05.|Negative binomial regression model|||||0.210|0.046|<0.0001
72408717|NCT03161314|144326106|SUPERIORITY|||||||0.66|||||||t-test, 2 sided|||Baseline||||0.660
72408718|NCT03161314|144326106|SUPERIORITY|||||||0.734|||||||t-test, 2 sided|||2 weeks after the intervention||||0.734
72408719|NCT03161314|144326106|SUPERIORITY|||||||0.629|||||||t-test, 2 sided|||4 weeks after the intervention||||0.629
72408720|NCT03161314|144326106|SUPERIORITY|||||||0.752|||||||t-test, 2 sided|||1-month follow-up||||0.752
72408721|NCT03161314|144326106|SUPERIORITY|||||||0.512|||||||t-test, 2 sided|||2-month follow-up||||0.512
72408722|NCT03161314|144326106|SUPERIORITY||||||<|0.001|||||||ANOVA|||Within group comparison||||<0.001
72536130|NCT03417102|144601825|SUPERIORITY||Least Square (LS) Mean difference|-28.72|||<|0.0001|TWO_SIDED|95.0|-39.07|-18.37||Analysis of Covariance (ANCOVA) model included treatment arm and randomization strata of number of bleeds (\<=10, \> 10) as fixed effects, Baseline score as a covariate. Significance threshold was at 0.05.|ANCOVA|||||-18.37|-39.07|<0.0001
72408723|NCT03161314|144326106|SUPERIORITY||||||<|0.001|||||||ANOVA|||Within group comparison||||<0.001
72408724|NCT03161314|144326107|SUPERIORITY|||||||0.128|||||||t-test, 2 sided|||Baseline||||0.128
72408725|NCT03161314|144326107|SUPERIORITY|||||||0.889|||||||t-test, 2 sided|||2 weeks after the intervention||||0.889
72408726|NCT03161314|144326107|SUPERIORITY|||||||0.793|||||||t-test, 2 sided|||4 weeks after the intervention||||0.793
72408727|NCT03161314|144326107|SUPERIORITY|||||||0.602|||||||t-test, 2 sided|||1-month follow-up||||0.602
72408728|NCT03161314|144326107|SUPERIORITY|||||||0.574|||||||t-test, 2 sided|||2-month follow-up||||0.574
72408729|NCT03161314|144326107|SUPERIORITY||||||<|0.001|||||||ANOVA|||Within group comparison||||<0.001
72408730|NCT03161314|144326107|SUPERIORITY||||||<|0.001|||||||ANOVA|||Within group comparison||||<0.001
72408731|NCT03161314|144326108|SUPERIORITY|||||||0.374|||||||t-test, 2 sided|||Baseline||||0.374
72408732|NCT03161314|144326108|SUPERIORITY|||||||0.674|||||||t-test, 2 sided|||2 weeks after the intervention||||0.674
72408733|NCT03161314|144326108|SUPERIORITY|||||||0.781|||||||t-test, 2 sided|||4 weeks after the intervention||||0.781
72408734|NCT03161314|144326108|SUPERIORITY|||||||0.778|||||||t-test, 2 sided|||1-month follow-up||||0.778
72408735|NCT03161314|144326108|SUPERIORITY|||||||0.727|||||||t-test, 2 sided|||2-month follow-up||||0.727
72408736|NCT03161314|144326108|SUPERIORITY|||||||0.014|||||||ANOVA|||Within group comparison||||0.014
72408737|NCT03161314|144326108|SUPERIORITY|||||||0.002|||||||ANOVA|||Within group comparison||||0.002
72408738|NCT03161314|144326109|SUPERIORITY|||||||0.39|||||||t-test, 2 sided|||Baseline||||0.390
72408739|NCT03161314|144326109|SUPERIORITY|||||||0.77|||||||t-test, 2 sided|||2 weeks after the intervention||||0.770
72408740|NCT03161314|144326109|SUPERIORITY|||||||0.603|||||||t-test, 2 sided|||4 weeks after the intervention||||0.603
72408741|NCT03161314|144326109|SUPERIORITY|||||||0.922|||||||t-test, 2 sided|||1-month follow-up||||0.922
72408742|NCT03161314|144326109|SUPERIORITY|||||||0.56|||||||t-test, 2 sided|||2-month follow-up||||0.560
72408743|NCT03161314|144326109|SUPERIORITY|||||||0.181|||||||ANOVA|||Within group comparison||||0.181
72408744|NCT03161314|144326109|SUPERIORITY||||||<|0.001|||||||ANOVA|||Within group comparison||||<0.001
72408745|NCT03161314|144326110|SUPERIORITY|||||||0.334|||||||t-test, 2 sided|||Baseline||||0.334
72408746|NCT03161314|144326110|SUPERIORITY|||||||0.766|||||||t-test, 2 sided|||2 weeks after the intervention||||0.766
72408747|NCT03161314|144326110|SUPERIORITY|||||||0.598|||||||t-test, 2 sided|||4 weeks after the intervention||||0.598
72408748|NCT03161314|144326110|SUPERIORITY|||||||0.682|||||||t-test, 2 sided|||1-month follow-up||||0.682
72536131|NCT03417102|144601826|SUPERIORITY||LS Mean difference|-14.85|||<|0.0001|TWO_SIDED|95.0|-21.37|-8.33||ANCOVA model included treatment arm and randomization strata of number of bleeds (\<=10, \> 10) as fixed effects, Baseline score as a covariate. Significance threshold was at 0.05.|ANCOVA|||||-8.33|-21.37|<0.0001
72536132|NCT02062385|144601829|SUPERIORITY_OR_OTHER||1 - (Incidence V260 / Incidence Placebo)|69.3|||<|0.001|TWO_SIDED|95.0|54.5|79.7|||Clopper-Pearson|To calculate the confidence interval and associated p-value, an exact conditional method based on a Poisson distribution was used.||V260 will be considered efficacious if the lower bound of the two-sided confidence interval for efficacy is \>0% at the final analysis||79.7|54.5|<0.001
72536133|NCT00526227|144601837|OTHER|An exact one-sided 97% upper confidence bound or a p-value will be calculated based on the observed percentage of subjects with an USADE within the first month post-implant. This rate will be considered acceptable if the one-sided 97% upper confidence bound is less than 10% or, equivalently, if the p-value is less than 0.0304.|Percentage|7.7|||||ONE_SIDED|97.0|||||||The CI was calculated based on 44 patients at interim analysis: 0 USADE were reported within 1-month post implant, ie 0% of subjects experienced a USADE. The one-sided 97% exact binomial upper confidence bound was 7.7% which is lower than 10%.|"H 0 (null hypothesis): P ≥ 10%; H A (alternative hypothesis): P \< 10%, where P is the percentage of subjects experiencing a USADE through the 1-month post implant.~An upper limit of the confidence interval of the percentage subjects with USADE not greater than or equal to 10% at the 1-month follow-up visit provides a reasonably-sized clinical study with sufficient power to detect USADEs."||||
72536134|NCT06212544|144601842|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<0.05
72536135|NCT04074109|144601857|OTHER|This is a feasibility study which is not powered for efficacy. Therefore no formal statistical tests are used.||||||||||||This is a feasibility study which is not powered for efficacy. Therefore no formal statistical tests are used.|||||This is a feasibility study which is not powered for efficacy. Therefore no formal statistical tests are used.|||
72536136|NCT04074109|144601857|OTHER|||||||||||||||||This is a feasibility study which is not powered for efficacy. Therefore no formal statistical tests are used. We report percentages and frequencies to show feasibility|This is a feasibility study which is not powered for efficacy. Therefore no formal statistical tests are used.|||
72536137|NCT00706901|144601860|NON_INFERIORITY_OR_EQUIVALENCE|Zero-inflated Poisson model with random intercept to account for correlation between repeated measurements of the responses within subjects was conducted.|||||<|0.01|TWO_SIDED||||||Zero inflated Poisson model|||||||<0.01
72536138|NCT00706901|144601860|NON_INFERIORITY_OR_EQUIVALENCE|Zero-hurdle Poisson model with random intercept to account for correlation between repeated measurements of the responses within subjects was conducted.||||||0.02|TWO_SIDED||||||zero-hurdle Poisson model|||||||0.02
72536139|NCT00706901|144601861|NON_INFERIORITY_OR_EQUIVALENCE|A Zero-inflated Poisson model with random intercept to account for correlation between repeated measurements of the responses within subjects was conducted.|||||<|0.01|TWO_SIDED||||||Zero inflated Poisson model|||||||<0.01
72536140|NCT00706901|144601861|NON_INFERIORITY_OR_EQUIVALENCE|Zero-hurdle Poisson model with random intercept to account for correlation between repeated measurements of the responses within subjects was conducted.||||||0.0002|TWO_SIDED||||||Zero-hurdle Poisson model|||||||.0002
72536141|NCT00706901|144601862|NON_INFERIORITY_OR_EQUIVALENCE|To examine differences between GMI and TCC on SECs, a two-component Weibull mixture model for effectively dealing with zero-heavy continuous data was conducted.||||||0.04|TWO_SIDED||||||Weibull mixture model|||||||0.04
72536142|NCT00706901|144601862|NON_INFERIORITY_OR_EQUIVALENCE|A generalized linear mixed model with correlated errors to account for correlation between repeated measurements of the response within subjects was conducted.||||||0.47|TWO_SIDED||||||Mixed Models Analysis|||||||0.47
72536143|NCT00706901|144601863|NON_INFERIORITY_OR_EQUIVALENCE|Zero inflated Poisson model with random intercept to account for correlation between repeated measurement of the responses within subjects was conducted.|||||<|0.01|TWO_SIDED||||||Zero inflated Poisson model|||||||<0.01
72408749|NCT03161314|144326110|SUPERIORITY|||||||0.707|||||||t-test, 2 sided|||2-month follow-up||||0.707
72536144|NCT00706901|144601863|NON_INFERIORITY_OR_EQUIVALENCE|Zero-hurdle Poisson model with random intercept to account for correlation between repeated measurements of the responses within subjects was conducted.|||||<|0.0001|TWO_SIDED||||||Zero-hurdle Poisson model|||||||<.0001
72536145|NCT00706901|144601864|NON_INFERIORITY_OR_EQUIVALENCE|Zero inflated Poisson model with random intercept to account for correlation between repeated measurement of the responses within subjects was conducted.|||||<|0.0001|TWO_SIDED||||||Zero inflated Poisson model|||||||<.0001
72536146|NCT00706901|144601864|NON_INFERIORITY_OR_EQUIVALENCE|Zero-hurdle Poisson model with random intercept to account for correlation between repeated measurements of the responses within subjects was conducted.||||||0.02|TWO_SIDED||||||Zero-hurdle Poisson model|||||||0.02
72536147|NCT00706901|144601865|NON_INFERIORITY_OR_EQUIVALENCE|Zero inflated Poisson model with random intercept to account for correlation between repeated measurement of the responses within subjects was conducted.||||||0.17|TWO_SIDED||||||Zero inflated Poisson model|||||||0.17
72536148|NCT00706901|144601865|NON_INFERIORITY_OR_EQUIVALENCE|Zero-hurdle Poisson model with random intercept to account for correlation between repeated measurements of the responses within subjects was conducted.||||||0.67|TWO_SIDED||||||Zero-hurdle Poisson model|||||||0.67
72536149|NCT01656850|144601879|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.0001
72536150|NCT01656850|144601880|SUPERIORITY_OR_OTHER|||||||0.2786|TWO_SIDED||||||Mixed Models Analysis|||||||0.2786
72536151|NCT01656850|144601881|SUPERIORITY_OR_OTHER|||||||0.42|TWO_SIDED||||||Mixed Models Analysis|||||||0.420
72536152|NCT01656850|144601882|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.0001
72626643|NCT00560417|144782238|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.92||||0.003|TWO_SIDED|95.0|3.66|18.19||p-value is for Endpoint Evening Pre-Meal.|ANCOVA|Variable = Treatment + Baseline + Baseline HbA1c Group + Baseline SU Group||||18.19|3.66|0.003
72408750|NCT03161314|144326110|SUPERIORITY|||||||0.008|||||||ANOVA|||Within group comparison||||0.008
72408751|NCT03161314|144326110|SUPERIORITY|||||||0.002|||||||ANOVA|||Within group comparison||||0.002
72408752|NCT03161314|144326111|SUPERIORITY|||||||0.287|||||||t-test, 2 sided|||Baseline||||0.287
72536153|NCT01656850|144601883|SUPERIORITY_OR_OTHER|||||||0.2412|TWO_SIDED||||||Mixed Models Analysis|||||||0.2412
72408753|NCT03161314|144326111|SUPERIORITY|||||||0.861|||||||t-test, 2 sided|||2 weeks after the intervention||||0.861
72408754|NCT03161314|144326111|SUPERIORITY|||||||0.641|||||||t-test, 2 sided|||4 weeks after the intervention||||0.641
72408755|NCT03161314|144326111|SUPERIORITY|||||||0.864|||||||t-test, 2 sided|||1-month follow-up||||0.864
72408756|NCT03161314|144326111|SUPERIORITY|||||||0.888|||||||t-test, 2 sided|||2-month follow-up||||0.888
72408757|NCT03161314|144326111|SUPERIORITY|||||||0.262|||||||ANOVA|||Within group comparison||||0.262
72408758|NCT03161314|144326111|SUPERIORITY||||||<|0.001|||||||ANOVA|||Within group comparison||||<0.001
72408759|NCT02357576|144326131|OTHER|Percentage and frequencies were used to describe the incidence of PNAC in the two groups.||||||0.617|||||||Fisher Exact|||||||0.617
72408760|NCT02357576|144326132|OTHER|Percentage and frequencies were used to describe the incidence of severe PNAC.||||||0.45|||||||Fisher Exact|||||||0.450
72536154|NCT01656850|144601884|SUPERIORITY_OR_OTHER|||||||0.3837|TWO_SIDED||||||Mixed Models Analysis|||||||0.3837
72536155|NCT01656850|144601885|SUPERIORITY_OR_OTHER|||||||0.9784|TWO_SIDED||||||Mixed Models Analysis|||||||0.9784
72408761|NCT02357576|144326133|OTHER|The Kaplan Meier curve was used to evaluated the time to first PNAC event.||||||0.2716|||||||Log Rank|A log rank test was used to test the equality of the survival curve between the two groups.||||||0.2716
72408762|NCT00128180|144326150|SUPERIORITY_OR_OTHER|||||||0.18||95.0|||||Fisher Exact|||||||0.18
72408763|NCT03296163|144326164|EQUIVALENCE|"Equivalence analysis was based on the risk ratio (RR) (MB02/EU-approved Avastin) with an equivalence margin predefined \[0.73, 1.36\].~The ORR estimate was stratified using the Cochran-Mantel-Haenszel estimate of the RR and corresponding 2-sided 90% confidence interval (CI)."|Risk Ratio (RR)|0.91|||||TWO_SIDED|90.0|0.78|1.06|||||Direction of comparison is: For RR: MB02/EU-approved Avastin. 95% CI was also calculated: (0.758, 1.092)|||1.060|0.780|
72408764|NCT03296163|144326164|EQUIVALENCE|The ORR estimate was stratified using the Cochran-Mantel-Haenszel estimate of the risk difference (RD) (MB02-EU-approved Avastin) with an equivalence margin predefined \[-12%, 12%\] and corresponding 2-sided 95% CI.|Risk Difference (RD)|-4.02|||||TWO_SIDED|90.0|-10.51|2.47|||||Direction of comparison is: For RD: MB02 - EU-approved Avastin. 95% CI was also calculated: (-11.76, 3.71)|||2.47|-10.51|
72536156|NCT01656850|144601886|SUPERIORITY_OR_OTHER|||||||0.5868|TWO_SIDED||||||Mixed Models Analysis|||||||0.5868
72626644|NCT00560417|144782238|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.19||||0.002|TWO_SIDED|95.0|5.44|22.94||p-value is for Endpoint Evening Postprandial.|ANCOVA|Variable = Treatment + Baseline + Baseline HbA1c Group + Baseline SU Group||||22.94|5.44|0.002
72408765|NCT03296163|144326165|OTHER|Hazard ratio of MB02 versus EU-approved Avastin; a hazard ratio =1 indicated no difference in progressive disease(PD)/death between 2 reporting groups; \>1 indicated an increase in PD/death in MB02; \<1 indicated an increase in PD/death in EU-approved Avastin.|Hazard Ratio (HR)|1.187|||||TWO_SIDED|95.0|0.98|1.44||||||||1.44|0.98|
72408766|NCT03296163|144326166|OTHER||Hazard Ratio (HR)|1.108|||||TWO_SIDED|95.0|0.827|1.485||||||||1.485|0.827|
72408767|NCT00414050|144326175|NON_INFERIORITY_OR_EQUIVALENCE|Modified Process Hepatitis B vaccine-5µg (micrograms) declared non-inferior to RECOMBIVAX HB™ if the lower bound of the 95% Confidence Interval for the ratio of Geometric Mean Titers (Modified Process Vaccine 5 micrograms/RECOMBIVAX HB™) was \>= 0.67. The study had 98 percent power for this test, based on an assumption of true equality.|Ratio of geometric means|1.99|||||TWO_SIDED|95.0|1.69|2.35||||||Comparison of Induced (effected) Geometric Mean Titer for the Modified Hepatitis B Process Vaccine and RECOMBIVAX Hepatitis B vaccine.||2.35|1.69|
72408768|NCT03495908|144326179|NON_INFERIORITY|Non-inferiority margin is 0.4% HbA1c|Mean Difference (Net)|-0.2207||||0.007|TWO_SIDED|95.0|-0.6654|0.2241||Non-inferiority p-value based on the 0.4% non-inferiority margin|Mixed Models Analysis||RHI - RAI estimated treatment difference. Upper confidence interval 0.22 is less than the 0.4% non-inferiority margin.|RHI - RAI estimated treatment difference (ETD) in HbA1c. Per-protocol analysis is the pre-specified primary outcome.||0.2241|-0.6654|0.007
72408769|NCT03495908|144326180|SUPERIORITY|Comparison of Post-randomization prevalence of hypoglycemia based on 7-point glucose profiles.||||||0.82|||||||Fisher Exact|||Post-randomization prevalence of hypoglycemia based on 7-point glucose profiles.||||.82
72408770|NCT03495908|144326181|SUPERIORITY|Analysis of the 7-point profiles within the ITT population (n=136)|Risk Ratio (RR)|0.925||||0.861|TWO_SIDED|95.0|0.386|2.217||Results are from a Poisson regression model with repeated measures; generalized estimating equations (GEE) approach.|Regression, Poisson|Poisson regression model with repeated measures; generalized estimating equations (GEE) approach|The incidence rate ratio quantitates the risk of hypoglycemia in the RHI group (RR numerator) compared with the RAI group (RR numerator). Results from Poisson regression model with repeated measures; generalized estimating equations (GEE) approach.|Level 1 (≤70 mg/dL or (\<3.9 mmol/L)) and level 2 hypoglycemia (\<54 mg/dL (\<3.0 mmol/L)) events are analyzed. No level 3 events were reported for either group.||2.217|0.386|0.861
72408771|NCT03495908|144326182|SUPERIORITY||Mean Difference (Net)|-0.01073||||0.415|TWO_SIDED|95.0|-0.03674|0.01528|||Mixed Models Analysis||Between Group Comparison (RHI-RAI) Estimated Treatment Difference (ETD) mixed effects model analysis|RHI versus RAI for Insulin Intent-to-treat Population N=136 Mixed Model Estimates for Insulin TDD U/kg I||0.01528|-0.03674|0.415
72408772|NCT03495908|144326183|SUPERIORITY||Mean Difference (Net)|-1.0776||||0.32|TWO_SIDED|95.0|-3.2139|1.0587|||Mixed Models Analysis||Between Group Comparison (RHI-RAI) Estimated Treatment Difference (ETD) mixed effects model analysis|||1.0587|-3.2139|0.320
72408773|NCT03495908|144326184|SUPERIORITY||Mean Difference (Net)|-265.85|||<|0.0001|TWO_SIDED|95.0|-288.6|-243.11|||Mixed Models Analysis||Estimated Treatment Difference (RHI-RAI) from repeated measures mixed model least squares estimates|||-243.11|-288.60|<0.0001
72536157|NCT01656850|144601887|SUPERIORITY_OR_OTHER|||||||0.1101|TWO_SIDED||||||Mixed Models Analysis|||||||0.1101
72536158|NCT01656850|144601888|SUPERIORITY_OR_OTHER|||||||0.7823|TWO_SIDED||||||Mixed Models Analysis|||||||0.7823
72536159|NCT01656850|144601889|SUPERIORITY_OR_OTHER|||||||0.557|TWO_SIDED||||||Mixed Models Analysis|||||||0.5570
72536160|NCT01656850|144601890|SUPERIORITY_OR_OTHER|||||||0.6263|TWO_SIDED||||||Mixed Models Analysis|||||||0.6263
72536161|NCT01656850|144601891|SUPERIORITY_OR_OTHER|||||||0.8328|TWO_SIDED||||||Mixed Models Analysis|||||||0.8328
72536162|NCT01656850|144601892|SUPERIORITY_OR_OTHER|||||||0.7758|TWO_SIDED||||||Mixed Models Analysis|||||||0.7758
72536163|NCT01656850|144601893|SUPERIORITY_OR_OTHER|||||||0.0476|TWO_SIDED||||||Mixed Models Analysis|||||||0.0476
72536164|NCT01656850|144601894|SUPERIORITY_OR_OTHER|||||||0.1205|TWO_SIDED||||||Mixed Models Analysis|||||||0.1205
72408774|NCT03495908|144326185|NON_INFERIORITY|Change in A1C Non-inferiority Margin is 0.4%|Mean Difference (Net)|-0.1317||||0.02|TWO_SIDED|95.0|-0.5838|0.3205||p-value for non-inferiority|Mixed Models Analysis||Between Group Difference (RHI-RAI) mixed effects repeated measures model analysis.Upper confidence interval 0.32 is less than the 0.4% non-inferiority margin.|Intent-to-treat secondary outcome of HbA1c response for assessment of non-inferiority of RHI compared to RAI||0.3205|-0.5838|0.02
72408775|NCT03304379|144326188|SUPERIORITY||Least Square (LS) Mean Difference|-0.63|||=|0.0003|TWO_SIDED|95.0|-0.971|-0.286||Threshold for significance at 0.05 level.|MMRM|||Analyses were based on a multiple imputation approach using a Mixed-Effect Model With Repeated Measure (MMRM) model with baseline randomization strata, baseline, treatment, visit and treatment by-visit interaction.||-0.286|-0.971|= 0.0003
72408776|NCT03304379|144326188|SUPERIORITY||LS Mean Difference|-0.77|||>|0.0001|TWO_SIDED|95.0|-1.154|-0.383||Threshold for significance at 0.05 level.|MMRM|||"(mFAS)~Analyses were based on a multiple imputation approach using a MMRM model with baseline, randomization strata, baseline, treatment, visit and treatment by-visit interaction"||-0.383|-1.154|> 0.0001
72408777|NCT03304379|144326189|SUPERIORITY||LS Mean Difference|-0.64|||=|0.0003|TWO_SIDED|95.0|-0.981|-0.29||Threshold for significance at 0.05 level.|MMRM|||Analyses were based on a multiple imputation approach using a Mixed-Effect Model With Repeated Measure (MMRM) model with baseline randomization strata, baseline, treatment, visit and treatment by-visit interaction.||-0.290|-0.981|= 0.0003
72408778|NCT03304379|144326189|SUPERIORITY||LS Mean Difference|-0.82|||<|0.0001|TWO_SIDED|95.0|-1.198|-0.443||Threshold for significance at 0.05 level|MMRM|||"(mFAS)~Analyses were based on a multiple imputation approach using an Mixed-Effect Model With Repeated Measure (MMRM) model with baseline randomization strata, baseline, treatment, visit and treatment by-visit interaction."||-0.443|-1.198|<0.0001
72408779|NCT03304379|144326190|SUPERIORITY||Odds Ratio (OR)|1.581|||=|0.0013|TWO_SIDED|95.0|1.195|2.092||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level. Analyses are based on Cochran-Mantel-Haenszel model.||2.092|1.195|= 0.0013
72408780|NCT03304379|144326191|SUPERIORITY||LS Mean Difference|-0.14|||=|0.0365|TWO_SIDED|95.0|-0.28|-0.009||Threshold for significance at 0.05 level.|MMRM|||A hierarchical testing procedure was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level. Analyses are based on a multiple imputation approach using Mixed-Effect Model With Repeated Measure (MMRM) model.||-0.009|-0.28|= 0.0365
72536165|NCT01656850|144601895|SUPERIORITY_OR_OTHER|||||||0.1512|TWO_SIDED||||||Mixed Models Analysis|||||||0.1512
72536166|NCT01656850|144601896|SUPERIORITY_OR_OTHER|||||||0.7364|TWO_SIDED||||||Mixed Models Analysis|||||||0.7364
72536167|NCT01656850|144601897|SUPERIORITY_OR_OTHER|||||||0.1995|TWO_SIDED||||||Mixed Models Analysis|||||||0.1995
72408781|NCT01298063|144326207|NON_INFERIORITY_OR_EQUIVALENCE|Relative bioavailability|Geometric mean ratio|92.64|STANDARD_DEVIATION|33.6||0.1998|TWO_SIDED|90.0|67.96|126.27||P-value for ratio outside interval 80 - 125 percent|ANOVA|Adjusted (by treatment) geometric mean ratio|The standard deviation is actually the intra individual geometric coefficient of variation|||126.270|67.960|0.1998
72408782|NCT01298063|144326207|NON_INFERIORITY_OR_EQUIVALENCE|Relative bioavailability|Geometric mean ratio|94.88|STANDARD_DEVIATION|31.6||0.144|TWO_SIDED|90.0|72.278|124.549||P-value for ratio outside interval 80 - 125 percent|ANOVA|Adjusted (by treatment) geometric mean ratio|The standard deviation is actually the intra individual geometric coefficient of variation|||124.549|72.278|0.1440
72408783|NCT01298063|144326208|NON_INFERIORITY_OR_EQUIVALENCE|Relative bioavailability|Geometric mean ratio|109.47|STANDARD_DEVIATION|30.3||0.2002|TWO_SIDED|90.0|82.683|144.947||P-value for ratio outside interval 80 - 125 percent|ANOVA|Adjusted (by treatment) geometric mean ratio|The standard deviation is actually the intra individual geometric coefficient of variation|||144.947|82.683|0.2002
72408784|NCT01298063|144326208|NON_INFERIORITY_OR_EQUIVALENCE|Relative bioavailability|Geometric mean ratio|126.89|STANDARD_DEVIATION|42.8||0.5281|TWO_SIDED|90.0|86.028|187.159||P-value for ratio outside interval 80 - 125 percent|ANOVA|Adjusted (by treatment) geometric mean ratio|The standard deviation is actually the intra individual geometric coefficient of variation|||187.159|86.028|0.5281
72536168|NCT01656850|144601898|SUPERIORITY_OR_OTHER|||||||0.8528|TWO_SIDED||||||Mixed Models Analysis|||||||0.8528
72536169|NCT00296192|144601900|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.9|STANDARD_ERROR_OF_MEAN|2.91||||95.0|-2.9|8.7|||ANCOVA|||Analysis of covariance modeling change from baseline at 24 minutes post-dose in UPDRS Part III, controlling for treatment group and baseline value.||8.7|-2.9|
72536170|NCT00296192|144601900|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.1|STANDARD_ERROR_OF_MEAN|2.93||||95.0|-5.7|6.0|||ANCOVA|||Analysis of covariance modeling change from baseline at 24 minutes post-dose in UPDRS Part III, controlling for treatment group and baseline value.||6.0|-5.7|
72536171|NCT00296192|144601900|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.9|STANDARD_ERROR_OF_MEAN|2.86||||95.0|-2.8|8.6|||ANCOVA|||Analysis of covariance modeling change from baseline at 24 minutes post-dose in UPDRS Part III, controlling for treatment group and baseline value.||8.6|-2.8|
72536172|NCT00296192|144601900|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.4|STANDARD_ERROR_OF_MEAN|3.02||||95.0|-7.4|4.6|||ANCOVA|||Analysis of covariance modeling change from baseline at 24 minutes post-dose in UPDRS Part III, controlling for treatment group and baseline value.||4.6|-7.4|
72536173|NCT00296192|144601901|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-8.6|STANDARD_ERROR_OF_MEAN|8.58||||95.0|-25.7|8.5|||ANCOVA|||Analysis of covariance modeling change from baseline to 34 minutes post-dose in tapping rate, controlling for treatment group and baseline value.||8.5|-25.7|
72536174|NCT00296192|144601901|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-16.8|STANDARD_ERROR_OF_MEAN|8.63||||95.0|-34.0|0.4|||ANCOVA|||Analysis of covariance modeling change from baseline to 34 minutes post-dose in tapping rate, controlling for treatment group and baseline value.||0.4|-34.0|
72408785|NCT01298063|144326209|NON_INFERIORITY_OR_EQUIVALENCE|Relative bioavailability|Geometric mean ratio|90.61|STANDARD_DEVIATION|32.8||0.2309|TWO_SIDED|90.0|66.915|122.705||P-value for ratio outside interval 80 - 125 percent|ANOVA|Adjusted (by treatment) geometric mean ratio|The standard deviation is actually the intra individual geometric coefficient of variation|||122.705|66.915|0.2309
72408786|NCT01298063|144326209|NON_INFERIORITY_OR_EQUIVALENCE|Relative bioavailability|Geometric mean ratio|94.49|STANDARD_DEVIATION|32.4||0.1546|TWO_SIDED|90.0|71.563|124.764||P-value for ratio outside interval 80 - 125 percent|ANOVA|Adjusted (by treatment) geometric mean ratio|The standard deviation is actually the intra individual geometric coefficient of variation|||124.764|71.563|0.1546
72408787|NCT00780572|144326233|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.9396||||0.668|TWO_SIDED|95.0|0.7068|1.249|||Regression, Cox|||||1.2490|0.7068|0.6680
72408788|NCT00395044|144326234|SUPERIORITY_OR_OTHER|||||||0.029||95.0|||||Mixed Models Analysis|||||||.029
72408789|NCT01469065|144326241|SUPERIORITY_OR_OTHER||Test-to-Reference Ratio (%)|84.87|||||TWO_SIDED|90.0|78.16|92.15||||||Test-to-Reference ratio and 90% confidence interval (CI) were based on adjusted geometric mean. Natural log-transformed change from baseline in MDG (Day 14) was analyzed using ANCOVA with country and treatment as fixed effect and log-transformed baseline as covariate. Placebo is the reference; the active drug group is the test. Formal statistical inference was not performed thus p value was not reported.||92.15|78.16|
72408790|NCT01469065|144326241|SUPERIORITY_OR_OTHER||Test-to-Reference Ratio (%)|89.8|||||TWO_SIDED|90.0|82.69|97.53||||||Test-to-Reference ratio and 90% confidence interval (CI) were based on adjusted geometric mean. Natural log-transformed change from baseline in MDG (Day 14) was analyzed using ANCOVA with country and treatment as fixed effect and log-transformed baseline as covariate. Placebo is the reference; the active drug group is the test.||97.53|82.69|
72536175|NCT00296192|144601901|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.4|STANDARD_ERROR_OF_MEAN|8.45||||95.0|-18.2|15.4|||ANCOVA|||Analysis of covariance modeling change from baseline to 34 minutes post-dose in tapping rate, controlling for treatment group and baseline value.||15.4|-18.2|
72536176|NCT00296192|144601901|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.5|STANDARD_ERROR_OF_MEAN|8.9||||95.0|-23.3|12.2|||ANCOVA|||Analysis of covariance modeling change from baseline to 34 minutes post-dose in tapping rate, controlling for treatment group and baseline value.||12.2|-23.3|
72536177|NCT00296192|144601902|SUPERIORITY_OR_OTHER||Difference in proportions|-20.6||||||95.0|-53.3|12.1|||Confidence interval|||95% confidence interval in difference in success rate||12.1|-53.3|
72536178|NCT00296192|144601902|SUPERIORITY_OR_OTHER||Difference in proportions|4.4||||||95.0|-25.9|34.7|||95% confidence interval|||95% confidence interval in difference in success rate||34.7|-25.9|
72408791|NCT01469065|144326241|SUPERIORITY_OR_OTHER||Test-to-Reference Ratio (%)|87.15|||||TWO_SIDED|90.0|80.27|94.63||||||Test-to-Reference ratio and 90% confidence interval (CI) were based on adjusted geometric mean. Natural log-transformed change from baseline in MDG (Day 14) was analyzed using ANCOVA with country and treatment as fixed effect and log-transformed baseline as covariate. Placebo is the reference; the active drug group is the test.||94.63|80.27|
72408792|NCT01469065|144326241|SUPERIORITY_OR_OTHER||Test-to-Reference Ratio (%)|78.28|||||TWO_SIDED|90.0|72.06|85.03||||||Test-to-Reference ratio and 90% confidence interval (CI) were based on adjusted geometric mean. Natural log-transformed change from baseline in MDG (Day 14) was analyzed using ANCOVA with country and treatment as fixed effect and log-transformed baseline as covariate. Placebo is the reference; the active drug group is the test.||85.03|72.06|
72536179|NCT00296192|144601902|SUPERIORITY_OR_OTHER||Difference in proportions|0.0||||||95.0|-30.6|30.6|||95% confidence interval|||95% confidence interval in difference in success rate||30.6|-30.6|
72536180|NCT00296192|144601902|SUPERIORITY_OR_OTHER||Difference in proportions|4.4||||||95.0|-25.9|34.7|||95% confidence interval|||95% confidence interval in difference in success rate||34.7|-25.9|
72536181|NCT02060526|144601929|SUPERIORITY_OR_OTHER_LEGACY||Difference between proportions|0.286||||0.4615|TWO_SIDED|95.0|-0.297|0.745|||Fisher Exact|||95% exact unconditional confidence interval of the difference in proportion between each of the treatment groups and the untreated control group was considered for the parameter estimation.||0.745|-0.297|0.4615
72536182|NCT02060526|144601929|SUPERIORITY_OR_OTHER_LEGACY||Difference between proportions|0.143||||1|TWO_SIDED|95.0|-0.423|0.647|||Fisher Exact|||95% exact unconditional confidence interval of the difference in proportion between each of the treatment groups and the untreated control group was considered for the parameter estimation.||0.647|-0.423|1.0000
72626645|NCT00560417|144782238|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.03||||0.415|TWO_SIDED|95.0|-10.35|4.28||p-value is for Endpoint 0300 Hours.|ANCOVA|Variable = Treatment + Baseline + Baseline HbA1c Group + Baseline SU Group||||4.28|-10.35|0.415
72626646|NCT00560417|144782238|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.39||||0.015|TWO_SIDED|95.0|1.46|13.32||p-value is for Endpoint Daily Mean 7-Point Blood Glucose.|ANCOVA|Variable = Treatment + Baseline + Baseline HbA1c Group + Baseline SU Group||||13.32|1.46|0.015
72626647|NCT00560417|144782238|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.12||||0.021|TWO_SIDED|95.0|1.1|13.14||p-value is for Endpoint Daily Mean Pre-Meal.|ANCOVA|Variable = Treatment + Baseline + Baseline HbA1c Group + Baseline SU Group||||13.14|1.10|0.021
72626648|NCT00560417|144782238|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.97|||<|0.001|TWO_SIDED|95.0|5.01|18.93||p-value is for Endpoint Daily Mean Postprandial.|ANCOVA|Variable = Treatment + Baseline + Baseline HbA1c Group + Baseline SU Group||||18.93|5.01|<0.001
72626649|NCT00560417|144782239|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.27||||0.131|TWO_SIDED|95.0|-0.68|5.22||p-value is for Baseline.|ANOVA|Variable = Treatment + Baseline HbA1c Group + Baseline SU Group||||5.22|-0.68|0.131
72408793|NCT01469065|144326254|SUPERIORITY_OR_OTHER||Test-to-Reference Ratio (%)|82.69|||||TWO_SIDED|90.0|76.06|89.9||||||Test-to-Reference ratio and 90% confidence interval (CI) were based on adjusted geometric mean. Natural log-transformed change from baseline in MDG (Day 13) was analyzed using ANCOVA with country and treatment as fixed effect and log-transformed baseline as covariate. Placebo is the reference; the active drug group is the test.||89.90|76.06|
72408794|NCT01469065|144326254|SUPERIORITY_OR_OTHER||Test-to-Reference Ratio (%)|85.39|||||TWO_SIDED|90.0|78.6|92.77||||||Test-to-Reference ratio and 90% confidence interval (CI) were based on adjusted geometric mean. Natural log-transformed change from baseline in MDG (Day 13) was analyzed using ANCOVA with country and treatment as fixed effect and log-transformed baseline as covariate. Placebo is the reference; the active drug group is the test.||92.77|78.60|
72573263|NCT03753763|144673200|SUPERIORITY||least square mean difference|0.5||||0.7751|TWO_SIDED|95.0|-3.1|4.1||A mixed-model repeated measures (MMRM) was used to analyze the change in anterior and lateral displacement from baseline.|Mixed Models Analysis|||The model included treatment, week of visit, and treatment-by-visit interaction as fixed effects and baseline score as a covariate||4.1|-3.1|0.7751
72626650|NCT00560417|144782239|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.99|||<|0.001|TWO_SIDED|95.0|2.82|9.16||p-value is for Endpoint.|ANOVA|Variable = Treatment + Baseline HbA1c Group + Baseline SU Group||||9.16|2.82|<0.001
72626651|NCT00560417|144782240|SUPERIORITY_OR_OTHER|||||||0.826||95.0||||p-value is for all reported hypoglycemic events at endpoint.|Fisher Exact|||||||0.826
72626652|NCT00560417|144782240|SUPERIORITY_OR_OTHER|||||||0.394||95.0||||p-value is for all reported hypoglycemic events overall.|Fisher Exact|||||||0.394
72626653|NCT00560417|144782240|SUPERIORITY_OR_OTHER|||||||0.07||95.0||||p-value is for non-nocturnal hypoglycemic events at endpoint.|Fisher Exact|||||||0.070
72626654|NCT00560417|144782240|SUPERIORITY_OR_OTHER|||||||0.133||95.0||||p-value is for non-nocturnal hypoglycemic events overall.|Fisher Exact|||||||0.133
72626655|NCT00560417|144782240|SUPERIORITY_OR_OTHER|||||||0.013||95.0||||p-value is for nocturnal hypoglycemic events at endpoint.|Fisher Exact|||||||0.013
72626656|NCT00560417|144782240|SUPERIORITY_OR_OTHER|||||||0.061||95.0||||p-value is for nocturnal hypoglycemic events overall.|Fisher Exact|||||||0.061
72626657|NCT00560417|144782240|SUPERIORITY_OR_OTHER|||||||0.248||95.0||||p-value is for severe hypoglycemic events overall.|Fisher Exact|||||||0.248
72626658|NCT00560417|144782241|SUPERIORITY_OR_OTHER|||||||0.628||95.0||||p-value is for All reported episodes rate - Endpoint.|Negative Binomial regression model|Total hypoglycemia count=Treatment+Baseline HbA1c Group+Baseline SU Group with log of patient's total number of days of exposure as an offset variable||||||0.628
72626659|NCT00560417|144782241|SUPERIORITY_OR_OTHER|||||||0.57||95.0||||p-value is for All reported episodes rate - Overall.|Negative Binomial regression model|Total hypoglycemia count=Treatment+Baseline HbA1c Group+Baseline SU Group with log of patient's total number of days of exposure as an offset variable||||||0.570
72626660|NCT00560417|144782241|SUPERIORITY_OR_OTHER|||||||0.116||95.0||||p-value is for Non-Nocturnal reported episodes rate - Endpoint.|Negative Binomial regression model|Total hypoglycemia count=Treatment+Baseline HbA1c Group+Baseline SU Group with log of patient's total number of days of exposure as an offset variable||||||0.116
72626661|NCT00560417|144782241|SUPERIORITY_OR_OTHER|||||||0.044||95.0||||p-value is for Non-Nocturnal reported episodes rate - Overall.|Negative Binomial regression model|Total hypoglycemia count=Treatment+Baseline HbA1c Group+Baseline SU Group with log of patient's total number of days of exposure as an offset variable||||||0.044
72626662|NCT00560417|144782241|SUPERIORITY_OR_OTHER|||||||0.006||95.0||||p-value is for Nocturnal reported episodes rate - Endpoint.|Negative Binomial regression model|Total hypoglycemia count=Treatment+Baseline HbA1c Group+Baseline SU Group with log of patient's total number of days of exposure as an offset variable||||||0.006
72626663|NCT00560417|144782241|SUPERIORITY_OR_OTHER|||||||0.004||95.0||||p-value is for Nocturnal reported episodes rate - Overall.|Negative Binomial regression model|Total hypoglycemia count=Treatment+Baseline HbA1c Group+Baseline SU Group with log of patient's total number of days of exposure as an offset variable||||||0.004
72573264|NCT03753763|144673201|SUPERIORITY||least square mean difference|0.2||||0.9076|TWO_SIDED|95.0|-3.3|3.7|||Mixed Models Analysis|A mixed-model repeated measures (MMRM) was used to analyze the change in from baseline in UMSARS Part II||The model included treatment, week of visit, and treatment-by-visit interaction as fixed effects and baseline score as a covariate.||3.7|-3.3|0.9076
72573265|NCT03753763|144673202|SUPERIORITY||least square mean difference|-1.1||||0.5386|TWO_SIDED|95.0|-4.8|2.6|||Mixed Models Analysis|A mixed-model repeated measures (MMRM) was used to analyze the change in from baseline in UMSARS Part II.||The model included treatment, week of visit, and treatment-by-visit interaction as fixed effects and baseline score as a covariate.||2.6|-4.8|0.5386
72573266|NCT03753763|144673203|SUPERIORITY||Least square mean difference|6.0||||0.3364|TWO_SIDED|95.0|-6.5|18.6|||Mixed Models Analysis|A mixed-model repeated measures (MMRM) was used to analyze the change in from baseline in MSA-QoL scale.||The model included treatment, week of visit, and treatment-by-visit interaction as fixed effects and baseline score as a covariate.||18.6|-6.5|0.3364
72573267|NCT03753763|144673204|SUPERIORITY||Least square mean difference|0.2||||0.7574|TWO_SIDED|95.0|-1.1|1.5|||ANCOVA|||The ANCOVA included change from baseline as the response variable, treatment group as a factor, and baseline score as a covariate||1.5|-1.1|0.7574
72573268|NCT03753763|144673205|SUPERIORITY||Least square mean difference|0.8||||0.6393|TWO_SIDED|95.0|-2.5|4.0|||Mixed Models Analysis|A mixed-model repeated measures (MMRM) was used to analyze the change from baseline in UDRS.||The model included treatment, week of visit, and treatment-by-visit interaction as fixed effects and baseline score as a covariate.||4.0|-2.5|0.6393
72573269|NCT03433755|144673208|SUPERIORITY||Treatment difference|-70.73|STANDARD_ERROR_OF_MEAN|3.65|<|0.0001|TWO_SIDED|95.0|-77.98|-63.48||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit as covariates.|Treatment difference = Evolocumab Q2W - Placebo Q2W|||-63.48|-77.98|< 0.0001
72626664|NCT00560417|144782242|SUPERIORITY_OR_OTHER|||||||0.343||95.0||||p-value is for endpoint.|ANCOVA|Variable = Treatment + Baseline + Baseline HbA1c Group + Baseline SU Group (Type III sums of squares)||||||0.343
72626665|NCT00560417|144782243|SUPERIORITY_OR_OTHER|||||||0.417||95.0||||p-value is for the change in body weight at endpoint in the ILPS treatment group.|t-test, 2 sided|||||||0.417
72626666|NCT00560417|144782243|SUPERIORITY_OR_OTHER|||||||0.041||95.0||||p-value is for the change in body weight at endpoint in the glargine treatment group.|t-test, 2 sided|||||||0.041
72626667|NCT00560417|144782243|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.38||||0.343|TWO_SIDED|95.0|-1.15|0.4||p-value is for change in body weight at endpoint between ILPS and glargine treatment groups.|ANOVA|||||0.40|-1.15|0.343
72626668|NCT00560417|144782244|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA|Variable = Treatment + Baseline HbA1c Group+ Baseline SU Group||||||<0.001
72573270|NCT03433755|144673208|SUPERIORITY||Treatment difference|-69.74|STANDARD_ERROR_OF_MEAN|3.41|<|0.0001|TWO_SIDED|95.0|-76.51|-62.97||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit as covariates.|Treatment difference = Evolocumab QM - Placebo QM|||-62.97|-76.51|< 0.0001
72408795|NCT01469065|144326254|SUPERIORITY_OR_OTHER||Test-to-Reference Ratio (%)|85.37|||||TWO_SIDED|90.0|78.59|92.76||||||Test-to-Reference ratio and 90% confidence interval (CI) were based on adjusted geometric mean. Natural log-transformed change from baseline in MDG (Day 13) was analyzed using ANCOVA with country and treatment as fixed effect and log-transformed baseline as covariate. Placebo is the reference; the active drug group is the test.||92.76|78.59|
72408796|NCT01469065|144326254|SUPERIORITY_OR_OTHER||Test-to-Reference Ratio (%)|75.82|||||TWO_SIDED|90.0|69.78|82.39||||||Test-to-Reference ratio and 90% confidence interval (CI) were based on adjusted geometric mean. Natural log-transformed change from baseline in MDG (Day 13) was analyzed using ANCOVA with country and treatment as fixed effect and log-transformed baseline as covariate. Placebo is the reference; the active drug group is the test.||82.39|69.78|
72536183|NCT02354352|144601957|NON_INFERIORITY|Using a Type I error rate of 5%, we conducted a power calculation using a non-inferiority test on 12-month change in Ecc. If there is truly no difference in the 12-month Ecc change between the spironolactone and eplerenone groups, 46 patients (23 in each group) would result in at least 80% power to ensure that the lower limit of a one-sided 95% confidence interval for the true difference between the spironolactone and eplerenone groups to be above the non-inferiority limit of -1.75.||||||0.5867|||||||Wilcoxon (Mann-Whitney)|||||||0.5867
72536184|NCT04633434|144601958|EQUIVALENCE|Test of whether the pretest and posttest scores are significantly different from zero.|Mean Difference (Final Values)|0.23|STANDARD_ERROR_OF_MEAN|0.56||0.69|TWO_SIDED||||||t-test, 2 sided||Estimation parameter based on paired t-test.|||||.690
72536185|NCT04633434|144601959|EQUIVALENCE|Test of whether pretest to posttest score change is greater than zero.|Mean Difference (Final Values)|0.647|STANDARD_ERROR_OF_MEAN|0.308||0.052|TWO_SIDED||||||t-test, 2 sided|||||||.052
72573271|NCT03433755|144673209|SUPERIORITY||Treatment difference|-70.87|STANDARD_ERROR_OF_MEAN|4.33|<|0.0001|TWO_SIDED|95.0|-79.47|-62.27||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit as covariates.|Treatment difference = Evolocumab Q2W - Placebo Q2W|||-62.27|-79.47|< 0.0001
72573272|NCT03433755|144673209|SUPERIORITY||Treatment difference|-65.81|STANDARD_ERROR_OF_MEAN|4.11|<|0.0001|TWO_SIDED|95.0|-73.97|-57.66||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit as covariates.|Treatment difference = Evolocumab QM - Placebo QM|||-57.66|-73.97|< 0.0001
72573273|NCT03433755|144673210|SUPERIORITY||Treatment difference|-76.5|STANDARD_ERROR_OF_MEAN|5.1|<|0.0001|TWO_SIDED|95.0|-86.6|-66.4||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit as covariates.|Treatment difference = Evolocumab Q2W - Placebo Q2W|||-66.4|-86.6|< 0.0001
72536186|NCT04633434|144601960|EQUIVALENCE|Test of whether pretest to posttest change is significantly different from zero.|Mean Difference (Final Values)|0.647|STANDARD_ERROR_OF_MEAN|0.41||0.135|TWO_SIDED||||||t-test, 2 sided|||||||.135
72573274|NCT03433755|144673210|SUPERIORITY||Treatment difference|-77.2|STANDARD_ERROR_OF_MEAN|5.3|<|0.0001|TWO_SIDED|95.0|-87.7|-66.7||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit as covariates.|Treatment difference = Evolocumab QM - Placebo QM|||-66.7|-87.7|< 0.0001
72626669|NCT02164864|144782250|NON_INFERIORITY|All non-inferiority tests were based on a margin of 1.38.|Hazard Ratio (HR)|0.52|||<|0.0001|TWO_SIDED|95.0|0.42|0.63||P values for noninferiority were calculated at a one-sided alpha level of 0.025|Regression, Cox|The Cox proportional hazard model is stratified by age, non-elderly vs elderly \[\<70 or \>=70 in Japan and \<80 or \>=80 years old elsewhere\].|Hazard Ratio (HR) and Wald confidence intervals are derived from a Cox proportional-hazard model|A pre-defined hierarchical testing approach was used. This was the first step in hierarchy. The upper bound of the Wald confidence interval (CI) of the HR of Dabigatran Etexilate 110mg vs Warfarin (one-sided 97.5%) was compared with this noninferiority margin for the testing of non-inferiority.||0.63|0.42|<0.0001
72536187|NCT04633434|144601961|EQUIVALENCE|Test of whether pretest to posttest change is significantly different from zero.|Mean Difference (Final Values)|4.24|STANDARD_ERROR_OF_MEAN|7.14||0.026|TWO_SIDED||||||t-test, 2 sided|||||||.026
72536188|NCT04633434|144601962|EQUIVALENCE|Test of whether pretest to posttest change is significantly different from zero.|Mean Difference (Final Values)|0.48|STANDARD_ERROR_OF_MEAN|0.09|<|0.001|TWO_SIDED||||||t-test, 2 sided|||||||<.001
72536189|NCT04633434|144601963|EQUIVALENCE|Test of whether pretest to posttest change is significantly different from zero.|Mean Difference (Final Values)|-0.66|STANDARD_ERROR_OF_MEAN|0.13|<|0.001|TWO_SIDED||||||t-test, 2 sided|||||||<.001
72408797|NCT01469065|144326254|SUPERIORITY_OR_OTHER||Difference between Test and Reference|-35.84|||||TWO_SIDED|90.0|-52.89|-18.78||||||Treatment difference and 90% confidence interval (CI) were based on adjusted geometric mean.||-18.78|-52.89|
72536190|NCT04633434|144601964|EQUIVALENCE|Test of whether pretest to posttest change is significantly different from zero.|Mean Difference (Final Values)|-1.11|STANDARD_ERROR_OF_MEAN|0.54||0.057|TWO_SIDED||||||t-test, 2 sided|||||||.057
72536191|NCT04633434|144601965|EQUIVALENCE|Test of whether pretest to posttest change is significantly different from zero.|Mean Difference (Final Values)|-3.44|STANDARD_ERROR_OF_MEAN|1.89|<|0.001|TWO_SIDED||||||t-test, 2 sided|||||||<.001
72536192|NCT04633434|144601966|EQUIVALENCE|Test of whether pretest to posttest change is significantly different from zero.|Mean Difference (Final Values)|-0.09|STANDARD_ERROR_OF_MEAN|0.1||0.352|TWO_SIDED||||||t-test, 2 sided|||||||.352
72536193|NCT04633434|144601967|EQUIVALENCE|Test of whether pretest to posttest change is significantly different from zero.|Mean Difference (Final Values)|0.23|STANDARD_ERROR_OF_MEAN|0.13||0.104|TWO_SIDED||||||t-test, 2 sided|||||||.104
72536194|NCT04633434|144601970|EQUIVALENCE|Test of whether pretest to posttest change is significantly different from zero.|Mean Difference (Final Values)|-0.33|STANDARD_ERROR_OF_MEAN|0.19||0.106|TWO_SIDED||||||t-test, 2 sided|||||||.106
72536195|NCT04633434|144601971|EQUIVALENCE|Test of whether pretest to posttest change is significantly different from zero.|Mean Difference (Final Values)|-0.64|STANDARD_ERROR_OF_MEAN|0.19||0.005|TWO_SIDED||||||t-test, 2 sided|||||||.005
72536196|NCT04633434|144601972|EQUIVALENCE|Test of whether pretest to posttest change is significantly different from zero.|Mean Difference (Final Values)|3.52|STANDARD_ERROR_OF_MEAN|1.9||0.082|TWO_SIDED||||||t-test, 2 sided|||||||.082
72536197|NCT01828164|144601996|SUPERIORITY_OR_OTHER||Percent Change|29.0||||0.0164|TWO_SIDED||||||t-test, 1 sided||Percent change in tooth movement rate on the treatment side as compared to the control side.|||||0.0164
72536198|NCT01828164|144601997|SUPERIORITY_OR_OTHER||Percent change|220.8||||0.0423|TWO_SIDED||||||t-test, 1 sided||Percent change in root resorption rate on the control side as compared to the treatment side.|||||0.0423
72536199|NCT01828164|144601998|NON_INFERIORITY|1 point on the 10-point pain scale was used as the non-inferiority margin.|||||<|0.001|||||||Bootstrapped mean difference|This test bootstrapped the mean difference (Treatment Arm - Control Arm) less 1, the non-inferiority margin, 1000 times.||||||<0.001
72536200|NCT04983589|144602004|SUPERIORITY||Percentage Difference|27.3|||<|0.0001|TWO_SIDED|95.0|17.3|37.4||Analysis was done using chi-square test.|Chi-squared||The 95% confidence interval for the proportion differences was calculated using the normal approximation based on pooled variance without continuity correction.|||37.4|17.3|<0.0001
72536201|NCT04983589|144602005|SUPERIORITY||Percentage Difference|26.4|||<|0.0001|TWO_SIDED|95.0|16.8|36.0||Analysis was done using chi-square test.|Chi-squared||The 95% confidence interval for the proportion differences was calculated using the normal approximation based on pooled variance without continuity correction.|||36.0|16.8|<0.0001
72536202|NCT04983589|144602006|SUPERIORITY||Percentage Difference|34.7|||<|0.0001|TWO_SIDED|95.0|22.7|46.7||Analysis was done using chi-square test.|Chi-squared||The 95% confidence interval for the proportion differences was calculated based on the normal approximation using pooled variance without continuity correction.|||46.7|22.7|<0.0001
72536203|NCT04983589|144602007|SUPERIORITY||Percentage Difference|20.6||||0.001|TWO_SIDED|95.0|8.6|32.6||Analysis was done using chi-square test.|Chi-squared||The 95% confidence interval for the proportion differences was calculated using the normal approximation using pooled variance without continuity correction.|||32.6|8.6|0.001
72536204|NCT00761969|144602011|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Log Rank|||Survival, major-event-free survival and event-free survival of patients with PAD and control subjects was estimated by the Kaplan-Meier method and compared by the log-rank test. The numbers of non-fatal events and revascularization procedures (which could be more than one per person) were compared using the Poisson regression - the outcome being the number of events per person-year.||||<0.001
72536205|NCT01040624|144602013|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||Chi-squared|One-sided binomial test of univariate probability distributions||||||<0.0001
72536206|NCT00585468|144602016|SUPERIORITY_OR_OTHER|||||||0.0163|||||||t-test, 2 sided|||||||0.0163
72536207|NCT00585468|144602017|SUPERIORITY_OR_OTHER|||||||0.039|||||||t-test, 2 sided|||||||0.039
72536208|NCT00585468|144602019|SUPERIORITY_OR_OTHER|||||||0.146|||||||t-test, 2 sided|||||||0.146
72536209|NCT00585468|144602020|SUPERIORITY_OR_OTHER|||||||0.4937|||||||t-test, 2 sided|||||||0.4937
72536210|NCT00585468|144602021|SUPERIORITY_OR_OTHER|||||||0.9669|||||||t-test, 2 sided|||||||0.9669
72536211|NCT00585468|144602023|SUPERIORITY_OR_OTHER|||||||0.9607|||||||t-test, 2 sided|||||||0.9607
72536212|NCT01353586|144602025|SUPERIORITY_OR_OTHER||Proportion of events|71.6|||||TWO_SIDED|95.0|63.3|79.8|||||The above supplemental analysis is to estimate the rate of subjects without documented symptomatic AF at Day 240 using the Kaplan-Meier time-to-event analysis method to accommodate the censored information from the two withdrawn subjects.|||79.8|63.3|
72536213|NCT00978120|144602033|SUPERIORITY_OR_OTHER|||||||0.014|||||||Fisher Exact|||||||0.014
72536214|NCT00978120|144602034|SUPERIORITY_OR_OTHER|||||||0.05|||||||Fisher Exact|||||||0.05
72536215|NCT00978120|144602037|SUPERIORITY_OR_OTHER|||||||0.47|||||||Fisher Exact|||||||0.470
72536216|NCT00978120|144602038|SUPERIORITY_OR_OTHER|||||||0.12|||||||Fisher Exact|||||||0.120
72536217|NCT00978120|144602039|SUPERIORITY_OR_OTHER|||||||0.284|||||||Fisher Exact|||||||0.284
72573275|NCT03433755|144673211|SUPERIORITY||Treatment difference|-75.9|STANDARD_ERROR_OF_MEAN|5.6|<|0.0001|TWO_SIDED|95.0|-87.1|-64.7||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit as covariates.|Treatment difference = Evolocumab Q2W - Placebo Q2W|||-64.7|-87.1|< 0.0001
72536218|NCT00978120|144602040|SUPERIORITY_OR_OTHER|||||||0.004|||||||Fisher Exact|||||||0.004
72536219|NCT00978120|144602041|SUPERIORITY_OR_OTHER|||||||0.341|||||||Fisher Exact|||||||0.341
72536220|NCT00978120|144602042|SUPERIORITY_OR_OTHER|||||||0.02|||||||Fisher Exact|||||||0.020
72536221|NCT00978120|144602043|SUPERIORITY_OR_OTHER|||||||0.245|||||||Fisher Exact|||||||0.245
72536222|NCT00978120|144602044|SUPERIORITY_OR_OTHER|||||||0.173|||||||Fisher Exact|||||||0.173
72536223|NCT00978120|144602045|SUPERIORITY_OR_OTHER|||||||0.362|||||||Fisher Exact|||||||0.362
72536224|NCT00978120|144602046|SUPERIORITY_OR_OTHER|||||||0.006|||||||Fisher Exact|||||||0.006
72536225|NCT00978120|144602047|SUPERIORITY_OR_OTHER|||||||0.016|||||||Fisher Exact|||||||0.016
72536226|NCT00978120|144602048|SUPERIORITY_OR_OTHER|||||||0.032|||||||Fisher Exact|||||||0.032
72536227|NCT01068418|144602051|SUPERIORITY_OR_OTHER||||||<|0.05||||||Threshold for significance was P\<0.05.|Mixed Models Analysis|||A repeated measures regression analysis model was used to examine the effect of vitamin D3 therapy on the mean arterial pressure (mean of five measurements at each time point) before and during angiotensin II infusions, before and after vitamin D3 therapy.||||<0.05
72536228|NCT01068418|144602052|SUPERIORITY_OR_OTHER||||||<|0.01||||||threshold for significance was P\<0.05.|Mixed Models Analysis|||A repeated measures regression analysis model was used to examine the effect of vitamin D3 therapy on the renal plasma flow (mean of three measurements at each time point) before and during angiotensin II infusions, before and after vitamin D3 therapy.||||<0.01
72536229|NCT03155269|144602059|OTHER||Mean Difference (Final Values)|-0.0423||||0.1324|TWO_SIDED|97.5|-0.1057|0.0211||The setting of the two-sided significance level of 0.025 was used for the 2 co-primary endpoints to ensure that the overall significance level for the primary endpoint was less than or equal to 0.05.|ANCOVA|Analysis was performed using ANCOVA model with product group and strata as fixed effects, and the corresponding baseline value as covariate.|Difference is test product minus reference product such that a negative difference favors the test product.|||0.0211|-0.1057|0.1324
72536230|NCT03155269|144602060|OTHER||Mean Difference (Final Values)|0.229||||0.0469|TWO_SIDED|97.5|-0.03|0.489||The setting of the two-sided significance level of 0.025 was used for the 2 co-primary endpoints to ensure that the overall significance level for the primary endpoint was less than or equal to 0.05.|ANCOVA|Analysis was performed using ANCOVA model with product group and strata as fixed effects, and the corresponding baseline value as covariate.|Difference is test product minus reference product such that a negative difference favors the test product.|||0.489|-0.030|0.0469
72536231|NCT03056456|144602084|SUPERIORITY||Ratio of Geometric LS Means|1.0|||||TWO_SIDED|90.0|0.81|1.23||||||Day 1||1.23|0.810|
72536232|NCT03056456|144602084|SUPERIORITY||Ratio of Geometric LS Means|1.01|||||TWO_SIDED|90.0|0.817|1.25||||||Day 3||1.25|0.817|
72536233|NCT03056456|144602085|SUPERIORITY||Ratio of Geometric LS Means|1.03|||||TWO_SIDED|90.0|0.808|1.31||||||Day 1||1.31|0.808|
72536234|NCT03056456|144602085|SUPERIORITY|Day 3|Ratio of Geometric LS Means|1.04|||||TWO_SIDED|90.0|0.82|1.32||||||||1.32|0.820|
72536235|NCT03733301|144602088|SUPERIORITY||Odds Ratio (OR)|1.88||||0.082|TWO_SIDED|95.0|0.92|3.85|||Regression, Logistic|||||3.85|0.92|0.082
72536236|NCT03733301|144602088|SUPERIORITY||Odds Ratio (OR)|2.77||||0.004|TWO_SIDED|95.0|1.38|5.56|||Regression, Logistic|||||5.56|1.38|0.004
72573276|NCT03433755|144673211|SUPERIORITY||Treatment difference|-73.0|STANDARD_ERROR_OF_MEAN|5.6|<|0.0001|TWO_SIDED|95.0|-84.1|-61.8||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit as covariates.|Treatment difference = Evolocumab QM - Placebo QM|||-61.8|-84.1|< 0.0001
72408798|NCT01469065|144326255|SUPERIORITY_OR_OTHER||Test-to-Reference Ratio (%)|86.72|||||TWO_SIDED|90.0|81.13|92.7||||||Test-to-Reference ratio and 90% confidence interval (CI) were based on adjusted geometric mean. Natural log-transformed change from baseline in Glucose AUC(2-6) was analyzed using ANCOVA with country and treatment as fixed effect and log-transformed baseline as covariate. Placebo is the reference; the active drug group is the test.||92.70|81.13|
72408799|NCT01469065|144326255|SUPERIORITY_OR_OTHER||Test-to-Reference Ratio (%)|91.13|||||TWO_SIDED|90.0|85.24|97.44||||||Test-to-Reference ratio and 90% confidence interval (CI) were based on adjusted geometric mean. Natural log-transformed change from baseline in Glucose AUC(2-6) was analyzed using ANCOVA with country and treatment as fixed effect and log-transformed baseline as covariate. Placebo is the reference; the active drug group is the test.||97.44|85.24|
72408800|NCT01469065|144326255|SUPERIORITY_OR_OTHER||Test-to-Reference Ratio (%)|87.05|||||TWO_SIDED|90.0|81.44|93.04||||||Test-to-Reference ratio and 90% confidence interval (CI) were based on adjusted geometric mean. Natural log-transformed change from baseline in Glucose AUC(2-6) was analyzed using ANCOVA with country and treatment as fixed effect and log-transformed baseline as covariate. Placebo is the reference; the active drug group is the test.||93.04|81.44|
72408801|NCT01469065|144326255|SUPERIORITY_OR_OTHER||Test-to-Reference Ratio (%)|77.95|||||TWO_SIDED|90.0|72.91|83.34||||||Test-to-Reference ratio and 90% confidence interval (CI) were based on adjusted geometric mean. Natural log-transformed change from baseline in Glucose AUC(2-6) was analyzed using ANCOVA with country and treatment as fixed effect and log-transformed baseline as covariate. Placebo is the reference; the active drug group is the test.||83.34|72.91|
72536237|NCT03733301|144602089|SUPERIORITY||Odds Ratio (OR)|2.62||||0.002|TWO_SIDED|95.0|1.44|4.76|||Regression, Logistic|||||4.76|1.44|0.002
72573277|NCT03433755|144673212|SUPERIORITY||Treatment difference|-61.2|STANDARD_ERROR_OF_MEAN|3.44|<|0.0001|TWO_SIDED|95.0|-68.04|-54.37||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit as covariates.|Treatment difference = Evolocumab Q2W - Placebo Q2W|||-54.37|-68.04|< 0.0001
72573278|NCT03433755|144673212|SUPERIORITY||Treatment difference|-62.15|STANDARD_ERROR_OF_MEAN|2.94|<|0.0001|TWO_SIDED|95.0|-67.97|-56.32||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit as covariates.|Treatment difference = Evolocumab QM - Placebo QM|||-56.32|-67.97|< 0.0001
72573279|NCT03433755|144673213|SUPERIORITY||Treatment difference|-61.45|STANDARD_ERROR_OF_MEAN|3.93|<|0.0001|TWO_SIDED|95.0|-69.25|-53.65||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit as covariates.|Treatment difference = Evolocumab Q2W - Placebo Q2W|||-53.65|-69.25|< 0.0001
72573280|NCT03433755|144673213|SUPERIORITY||Treatment difference|-56.65|STANDARD_ERROR_OF_MEAN|3.54|<|0.0001|TWO_SIDED|95.0|-63.66|-49.63||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit as covariates.|Treatment difference = Evolocumab QM - Placebo QM|||-49.63|-63.66|< 0.0001
72573281|NCT03433755|144673214|SUPERIORITY||Treatment Difference|-56.26|STANDARD_ERROR_OF_MEAN|3.12|<|0.0001|TWO_SIDED|95.0|-62.44|-50.07||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit as covariates.|Treatment difference = Evolocumab Q2W - Placebo Q2W|||-50.07|-62.44|< 0.0001
72408802|NCT01469065|144326256|SUPERIORITY_OR_OTHER||Test-to-Reference Ratio (%) at Day 2|100.04|||||TWO_SIDED|90.0|92.7|107.96||||||Test-to-Reference ratio of log-transformed change from baseline and 90% confidence interval (CI) of log-transformed change from baseline at Day 2 were based on adjusted geometric mean. Natural log-transformed change from baseline in FPG was analyzed using mixed effects model with country, treatment as fixed effect and log-transformed baseline as covariate. Placebo is the reference; the active drug group is the test.||107.96|92.70|
72573282|NCT03433755|144673214|SUPERIORITY||Treatment Difference|-57.0|STANDARD_ERROR_OF_MEAN|2.7|<|0.0001|TWO_SIDED|95.0|-62.35|-51.65||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit as covariates.|Treatment difference = Evolocumab QM - Placebo QM|||-51.65|-62.35|< 0.0001
72408803|NCT01469065|144326256|SUPERIORITY_OR_OTHER||Test-to-Reference Ratio (%) at Day 2|99.44|||||TWO_SIDED|90.0|92.04|107.43||||||Test-to-Reference ratio of log-transformed change from baseline and 90% confidence interval (CI) of log-transformed change from baseline at Day 2 were based on adjusted geometric mean. Natural log-transformed change from baseline in FPG was analyzed using mixed effects model with country, treatment as fixed effect and log-transformed baseline as covariate. Placebo is the reference; the active drug group is the test.||107.43|92.04|
72536238|NCT03733301|144602089|SUPERIORITY||Odds Ratio (OR)|3.27|||<|0.001|TWO_SIDED|95.0|1.8|5.97|||Regression, Logistic|||||5.97|1.80|< 0.001
72536239|NCT03733301|144602090|SUPERIORITY||Odds Ratio (OR)|1.24||||0.574|TWO_SIDED|95.0|0.59|2.62|||Regression, Logistic|||||2.62|0.59|0.574
72536240|NCT03733301|144602090|SUPERIORITY||Odds Ratio (OR)|2.07||||0.045|TWO_SIDED|95.0|1.02|4.2|||Regression, Logistic|||||4.20|1.02|0.045
72536241|NCT03733301|144602091|SUPERIORITY||Mean Difference (Final Values)|-13.08|STANDARD_ERROR_OF_MEAN|5.256||0.013|TWO_SIDED|95.0|-23.42|-2.73|||Mixed Models Analysis|||||-2.73|-23.42|0.013
72536242|NCT03733301|144602091|SUPERIORITY||Mean Difference (Final Values)|-22.13|STANDARD_ERROR_OF_MEAN|5.259|<|0.001|TWO_SIDED|95.0|-32.48|-11.78|||Mixed Models Analysis|||||-11.78|-32.48|<0.001
72408804|NCT01469065|144326256|SUPERIORITY_OR_OTHER||Test-to-Reference Ratio (%) at Day 2|101.67|||||TWO_SIDED|90.0|94.1|109.84||||||Test-to-Reference ratio of log-transformed change from baseline and 90% confidence interval (CI) of log-transformed change from baseline at Day 2 were based on adjusted geometric mean. Natural log-transformed change from baseline in FPG was analyzed using mixed effects model with country, treatment as fixed effect and log-transformed baseline as covariate. Placebo is the reference; the active drug group is the test.||109.84|94.10|
72408805|NCT01469065|144326256|SUPERIORITY_OR_OTHER||Test-to-Reference Ratio (%) at Day 2|96.82|||||TWO_SIDED|90.0|89.69|104.52||||||Test-to-Reference ratio of log-transformed change from baseline and 90% confidence interval (CI) of log-transformed change from baseline at Day 2 were based on adjusted geometric mean. Natural log-transformed change from baseline in FPG was analyzed using mixed effects model with country, treatment as fixed effect and log-transformed baseline as covariate. Placebo is the reference; the active drug group is the test.||104.52|89.69|
72536243|NCT03733301|144602092|SUPERIORITY||Odds Ratio (OR)|1.53||||0.364|TWO_SIDED|95.0|0.61|3.81|||Regression, Logistic|||||3.81|0.61|0.364
72536244|NCT03733301|144602092|SUPERIORITY||Odds Ratio (OR)|2.7||||0.022|TWO_SIDED|95.0|1.15|6.34|||Regression, Logistic|||||6.34|1.15|0.022
72536245|NCT03733301|144602093|SUPERIORITY||Odds Ratio (OR)|2.88||||0.002|TWO_SIDED|95.0|1.48|5.61|||Regression, Logistic|||||5.61|1.48|0.002
72536246|NCT03733301|144602093|SUPERIORITY||Odds Ratio (OR)|3.84|||<|0.001|TWO_SIDED|95.0|1.98|7.46|||Regression, Logistic|||||7.46|1.98|<0.001
72536247|NCT03733301|144602094|SUPERIORITY||Mean Difference (Final Values)|-0.82|STANDARD_ERROR_OF_MEAN|0.209|<|0.001|TWO_SIDED|95.0|-1.23|-0.41|||Mixed Models Analysis|||||-0.41|-1.23|<0.001
72536248|NCT03733301|144602094|SUPERIORITY||Mean Difference (Final Values)|-0.92|STANDARD_ERROR_OF_MEAN|0.209|<|0.001|TWO_SIDED|95.0|-1.33|-0.51|||Mixed Models Analysis|||||-0.51|-1.33|<0.001
72536249|NCT03733301|144602095|SUPERIORITY||Mean Difference (Final Values)|-1.15|STANDARD_ERROR_OF_MEAN|0.319|<|0.001|TWO_SIDED|95.0|-1.78|-0.52|||Mixed Models Analysis|||||-0.52|-1.78|<0.001
72536250|NCT03733301|144602095|SUPERIORITY||Mean Difference (Final Values)|-1.66|STANDARD_ERROR_OF_MEAN|0.322|<|0.001|TWO_SIDED|95.0|-2.3|-1.3|||Mixed Models Analysis|||||-1.30|-2.30|<0.001
72536251|NCT03733301|144602096|SUPERIORITY||Odds Ratio (OR)|2.57|||<|0.001|TWO_SIDED|95.0|1.47|4.49|||Regression, Logistic|||||4.49|1.47|<0.001
72536252|NCT03733301|144602096|SUPERIORITY||Odds Ratio (OR)|3.56|||<|0.001|TWO_SIDED|95.0|2.0|6.32|||Regression, Logistic|||||6.32|2.00|<0.001
72536253|NCT03733301|144602097|SUPERIORITY||Odds Ratio (OR)|1.3||||0.715|TWO_SIDED|95.0|0.32|5.31|||Regression, Logistic|||||5.31|0.32|0.715
72536254|NCT03733301|144602097|SUPERIORITY||Odds Ratio (OR)|3.02||||0.083|TWO_SIDED|95.0|0.86|10.56|||Regression, Logistic|||||10.56|0.86|0.083
72536255|NCT03733301|144602098|SUPERIORITY||Mean Difference (Final Values)|-8.48|STANDARD_ERROR_OF_MEAN|2.663||0.002|TWO_SIDED|95.0|-13.72|-3.24|||Mixed Models Analysis|||||-3.24|-13.72|0.002
72536256|NCT03733301|144602098|SUPERIORITY||Mean Difference (Final Values)|-14.38|STANDARD_ERROR_OF_MEAN|2.662|<|0.001|TWO_SIDED|95.0|-19.62|-9.14|||Mixed Models Analysis|||||-9.14|-19.62|<0.001
72536257|NCT03733301|144602099|SUPERIORITY||Odds Ratio (OR)|3.21||||0.204|TWO_SIDED|95.0|0.53|19.37|||Regression, Logistic|||||19.37|0.53|0.204
72536258|NCT03733301|144602099|SUPERIORITY||Odds Ratio (OR)|6.99||||0.025|TWO_SIDED|95.0|1.27|38.53|||Regression, Logistic|||||38.53|1.27|0.025
72536259|NCT03733301|144602100|SUPERIORITY||Mean Difference (Final Values)|-8.97|STANDARD_ERROR_OF_MEAN|2.591|<|0.001|TWO_SIDED|95.0|-14.07|-3.87|||Mixed Models Analysis|||||-3.87|-14.07|<0.001
72536260|NCT03733301|144602100|SUPERIORITY||Mean Difference (Final Values)|-11.69|STANDARD_ERROR_OF_MEAN|2.584|<|0.001|TWO_SIDED|95.0|-16.78|-6.61|||Mixed Models Analysis|||||-6.61|-16.78|<0.001
72536261|NCT03733301|144602101|SUPERIORITY|||||||0.721|||||||Fisher Exact|||||||0.721
72536262|NCT03733301|144602101|SUPERIORITY||||||>|0.999|||||||Fisher Exact|||||||>0.999
72536263|NCT03733301|144602102|SUPERIORITY||Mean Difference (Final Values)|-65.16|STANDARD_ERROR_OF_MEAN|24.149||0.0073|TWO_SIDED|95.0|-112.87|-17.65|||ANOVA|||||-17.65|-112.87|0.0073
72536264|NCT03733301|144602102|SUPERIORITY||Mean Difference (Final Values)|-91.14|STANDARD_ERROR_OF_MEAN|24.038||0.0002|TWO_SIDED|95.0|-138.43|-43.85|||ANOVA|||||-43.85|-138.43|0.0002
72536265|NCT03733301|144602103|SUPERIORITY||Mean Difference (Final Values)|-16.44|STANDARD_ERROR_OF_MEAN|4.658|<|0.001|TWO_SIDED|95.0|-25.6|-7.27|||Mixed Models Analysis|||||-7.27|-25.60|< 0.001
72536266|NCT03733301|144602103|SUPERIORITY||Mean Difference (Final Values)|-24.22|STANDARD_ERROR_OF_MEAN|4.672|<|0.001|TWO_SIDED|95.0|-33.42|-15.03|||Mixed Models Analysis|||||-15.03|-33.42|< 0.001
72536267|NCT03733301|144602104|SUPERIORITY||Mean Difference (Final Values)|-2.9|STANDARD_ERROR_OF_MEAN|1.046||0.006|TWO_SIDED|95.0|-4.96|-0.84|||Mixed Models Analysis|||||-0.84|-4.96|0.006
72536268|NCT03733301|144602104|SUPERIORITY||Mean Difference (Final Values)|-5.23|STANDARD_ERROR_OF_MEAN|1.043|<|0.001|TWO_SIDED|95.0|-7.28|-3.18|||Mixed Models Analysis|||||-3.18|-7.28|< 0.001
72536269|NCT03733301|144602105|SUPERIORITY||Mean Difference (Final Values)|-0.37|STANDARD_ERROR_OF_MEAN|0.13||0.005|TWO_SIDED|95.0|-0.63|-0.12|||Mixed Models Analysis|||||-0.12|-0.63|0.005
72536270|NCT03733301|144602105|SUPERIORITY||Mean Difference (Final Values)|-0.49|STANDARD_ERROR_OF_MEAN|0.13|<|0.001|TWO_SIDED|95.0|-0.75|-0.24|||Mixed Models Analysis|||||-0.24|-0.75|< 0.001
72536271|NCT03733301|144602106|SUPERIORITY||Mean Difference (Final Values)|-0.74|STANDARD_ERROR_OF_MEAN|0.425||0.083|TWO_SIDED|95.0|-1.57|0.1|||Mixed Models Analysis|||HADS Depression||0.10|-1.57|0.083
72536272|NCT03733301|144602106|SUPERIORITY||Mean Difference (Final Values)|-1.02|STANDARD_ERROR_OF_MEAN|0.423||0.016|TWO_SIDED|95.0|-1.85|-0.19|||Mixed Models Analysis|||HADS Depression||-0.19|-1.85|0.016
72536273|NCT03733301|144602106|SUPERIORITY||Mean Difference (Final Values)|-0.81|STANDARD_ERROR_OF_MEAN|0.415||0.051|TWO_SIDED|95.0|-1.63|0.0|||Mixed Models Analysis|||HADS Anxiety||0.00|-1.63|0.051
72536274|NCT03733301|144602106|SUPERIORITY||Mean Difference (Final Values)|-0.91|STANDARD_ERROR_OF_MEAN|0.413||0.028|TWO_SIDED|95.0|-1.72|-0.1|||Mixed Models Analysis|||HADS Anxiety||-0.10|-1.72|0.028
72536275|NCT03733301|144602107|SUPERIORITY||Mean Difference (Final Values)|-1.92|STANDARD_ERROR_OF_MEAN|0.832||0.022|TWO_SIDED|95.0|-3.56|-0.28|||Mixed Models Analysis|||||-0.28|-3.56|0.022
72536276|NCT03733301|144602107|SUPERIORITY||Mean Difference (Final Values)|-3.31|STANDARD_ERROR_OF_MEAN|0.829|<|0.001|TWO_SIDED|95.0|-4.94|-1.68|||Mixed Models Analysis|||||-1.68|-4.94|< 0.001
72536277|NCT03733301|144602108|SUPERIORITY||Mean Difference (Final Values)|2.01|STANDARD_ERROR_OF_MEAN|2.569||0.435|TWO_SIDED|95.0|-3.06|7.08|||Mixed Models Analysis|||Absenteeism||7.08|-3.06|0.435
72536278|NCT03733301|144602108|SUPERIORITY||Mean Difference (Final Values)|0.97|STANDARD_ERROR_OF_MEAN|2.569||0.706|TWO_SIDED|95.0|-4.1|6.04|||Mixed Models Analysis|||Absenteeism||6.04|-4.10|0.706
72536279|NCT03733301|144602108|SUPERIORITY|Presenteeism|Mean Difference (Final Values)|-8.12|STANDARD_ERROR_OF_MEAN|4.384||0.066|TWO_SIDED|95.0|-16.78|0.54|||Mixed Models Analysis|||||0.54|-16.78|0.066
72536280|NCT03733301|144602108|SUPERIORITY||Mean Difference (Final Values)|-10.73|STANDARD_ERROR_OF_MEAN|4.336||0.014|TWO_SIDED|95.0|-19.3|-2.17|||Mixed Models Analysis|||Presenteeism||-2.17|-19.30|0.014
72536281|NCT03733301|144602108|SUPERIORITY|Work Productivity Loss|Mean Difference (Final Values)|-7.93|STANDARD_ERROR_OF_MEAN|4.511||0.081|TWO_SIDED|95.0|-16.84|0.99|||Mixed Models Analysis|||||0.99|-16.84|0.081
72536282|NCT03733301|144602108|SUPERIORITY||Mean Difference (Final Values)|-10.71|STANDARD_ERROR_OF_MEAN|4.473||0.018|TWO_SIDED|95.0|-19.55|1.88|||Mixed Models Analysis|||Work productivity Loss||1.88|-19.55|0.018
72536283|NCT03733301|144602108|SUPERIORITY||Mean Difference (Final Values)|-9.8|STANDARD_ERROR_OF_MEAN|3.511||0.006|TWO_SIDED|95.0|-16.71|-2.89|||Mixed Models Analysis|||Activity Impairment||-2.89|-16.71|0.006
72536284|NCT03733301|144602108|SUPERIORITY||Mean Difference (Final Values)|-10.5|STANDARD_ERROR_OF_MEAN|3.5||0.003|TWO_SIDED|95.0|-17.39|-3.61|||Mixed Models Analysis|||Activity Impairment||-3.61|-17.39|0.003
72536285|NCT03733301|144602109|SUPERIORITY||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.017||0.176|TWO_SIDED|95.0|-0.01|0.06|||Mixed Models Analysis|||Health State Index US||0.06|-0.01|0.176
72536286|NCT03733301|144602109|SUPERIORITY||Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.017||0.004|TWO_SIDED|95.0|0.02|0.09|||Mixed Models Analysis|||Health State Index US||0.09|0.02|0.004
72536287|NCT03733301|144602109|SUPERIORITY||Mean Difference (Final Values)|0.03|STANDARD_ERROR_OF_MEAN|0.024||0.176|TWO_SIDED|95.0|-0.01|0.08|||Mixed Models Analysis|||Health State Index UK||0.08|-0.01|0.176
72536288|NCT03733301|144602109|SUPERIORITY||Mean Difference (Final Values)|0.07|STANDARD_ERROR_OF_MEAN|0.024||0.003|TWO_SIDED|95.0|0.02|0.12|||Mixed Models Analysis|||Health State Index UK||0.12|0.02|0.003
72536289|NCT03733301|144602110|SUPERIORITY||Mean Difference (Final Values)|4.12|STANDARD_ERROR_OF_MEAN|2.593||0.113|TWO_SIDED|95.0|-0.98|9.23|||Mixed Models Analysis|||||9.23|-0.98|0.113
72536290|NCT03733301|144602110|SUPERIORITY||Mean Difference (Final Values)|6.06|STANDARD_ERROR_OF_MEAN|2.592||0.02|TWO_SIDED|95.0|0.96|11.16|||Mixed Models Analysis|||||11.16|0.96|0.020
72536291|NCT03733301|144602111|SUPERIORITY||Mean Difference (Final Values)|10.04|STANDARD_ERROR_OF_MEAN|4.36||0.022|TWO_SIDED|95.0|1.46|18.36|||ANCOVA|||||18.36|1.46|0.022
72536292|NCT03733301|144602111|SUPERIORITY||Mean Difference (Final Values)|17.33|STANDARD_ERROR_OF_MEAN|4.34|<|0.001|TWO_SIDED|95.0|8.79|25.88|||ANCOVA|||||25.88|8.79|< 0.001
72536293|NCT03733301|144602112|SUPERIORITY||Odds Ratio (OR)|3.83||||0.006|TWO_SIDED|95.0|1.46|10.03|||Regression, Logistic|||||10.03|1.46|0.006
72536294|NCT03733301|144602112|SUPERIORITY||Odds Ratio (OR)|4.58||||0.002|TWO_SIDED|95.0|1.77|11.87|||Regression, Logistic|||||11.87|1.77|0.002
72536295|NCT03707145|144602120|SUPERIORITY||Partial Eta Squared|0.058|||||TWO_SIDED|||||||||Partial Eta Squared was calculated based on ANOVA with Time (pre-post) as within subject factor and Empowerment (Professional led versus Patient Empowered) as between subject factor.||||
72536296|NCT03707145|144602121|SUPERIORITY||Partial Eta Squared|0.008|||||TWO_SIDED|||||||||Partial Eta Squared was calculated based on ANOVA with Time (pre-post) as within subject factor and Empowerment (Professional led versus Patient Empowered) as between subject factor.||||
72536297|NCT05014672|144602127|SUPERIORITY||Ratio of geometric LS mean vs placebo|0.86||||0.0206|TWO_SIDED|95.0|0.746|0.994|||Mixed Model Repeated Measures|||||0.994|0.746|0.0206
72536298|NCT05014672|144602127|SUPERIORITY||Ratio of geometric LS mean vs placebo|0.81||||0.0057|TWO_SIDED|95.0|0.703|0.939|||Mixed Model Repeated Measures|||||0.939|0.703|0.0057
72536299|NCT05014672|144602128|SUPERIORITY||LS mean difference vs placebo|-2.16||||0.2214|TWO_SIDED|95.0|-7.785|3.458|||Mixed Model Repeated Measures|||||3.458|-7.785|0.2214
72536300|NCT05014672|144602128|SUPERIORITY||LS mean difference vs placebo|0.63||||0.591|TWO_SIDED|95.0|-4.859|6.12|||Mixed Model Repeated Measures|||||6.120|-4.859|0.5910
72536301|NCT05014672|144602131|SUPERIORITY||LS mean difference vs placebo|0.42||||0.5675|TWO_SIDED|95.0|-4.454|5.285|||Mixed Model Repeated Measures|||||5.285|-4.454|0.5675
72536302|NCT05014672|144602131|SUPERIORITY||LS mean difference vs placebo|0.02||||0.5032|TWO_SIDED|95.0|-4.886|4.926|||Mixed Model Repeated Measures|||||4.926|-4.886|0.5032
72536303|NCT05014672|144602132|SUPERIORITY||Ratio of geometric LS mean vs placebo|0.85||||0.0491|TWO_SIDED|95.0|0.692|1.033|||Mixed Model Repeated Measures|||||1.033|0.692|0.0491
72536304|NCT05014672|144602132|SUPERIORITY||Ratio of geometric LS mean vs placebo|0.95||||0.3099|TWO_SIDED|95.0|0.783|1.158|||Mixed Model Repeated Measures|||||1.158|0.783|0.3099
72536305|NCT05014672|144602138|SUPERIORITY||Ratio of geometric LS mean vs placebo|0.84||||0.0039|TWO_SIDED|95.0|0.743|0.954|||Mixed Model Repeated Measures|||||0.954|0.743|0.0039
72536306|NCT05014672|144602139|SUPERIORITY||LS mean difference vs placebo|0.3905||||0.3905|TWO_SIDED|95.0|-5.496|4.153|||Mixed Model Repeated Measures|||||4.153|-5.496|0.3905
72536307|NCT05014672|144602140|SUPERIORITY||LS mean difference vs placebo|0.21||||0.5393|TWO_SIDED|95.0|-3.968|4.381|||Mixed Model Repeated Measures|||||4.381|-3.968|0.5393
72536308|NCT05014672|144602141|SUPERIORITY||Ratio of geometric LS mean vs placebo|0.9||||0.1079|TWO_SIDED|95.0|0.759|1.065|||Mixed Model Repeated Measures|||||1.065|0.759|0.1079
72408806|NCT01469065|144326256|SUPERIORITY_OR_OTHER||Test-to-Reference Ratio (%) at Day 3|95.85|||||TWO_SIDED|90.0|88.82|103.44||||||Test-to-Reference ratio of log-transformed change from baseline and 90% confidence interval (CI) of log-transformed change from baseline at Day 3 were based on adjusted geometric mean. Natural log-transformed change from baseline in FPG was analyzed using mixed effects model with country, treatment as fixed effect and log-transformed baseline as covariate. Placebo is the reference; the active drug group is the test.||103.44|88.82|
72408807|NCT01469065|144326256|SUPERIORITY_OR_OTHER||Test-to-Reference Ratio (%) at Day 3|98.71|||||TWO_SIDED|90.0|91.37|106.64||||||Test-to-Reference ratio of log-transformed change from baseline and 90% confidence interval (CI) of log-transformed change from baseline at Day 3 were based on adjusted geometric mean. Natural log-transformed change from baseline in FPG was analyzed using mixed effects model with country, treatment as fixed effect and log-transformed baseline as covariate. Placebo is the reference; the active drug group is the test.||106.64|91.37|
72408808|NCT01469065|144326256|SUPERIORITY_OR_OTHER||Test-to-Reference Ratio (%) at Day 3|99.72|||||TWO_SIDED|90.0|92.3|107.73||||||Test-to-Reference ratio of log-transformed change from baseline and 90% confidence interval (CI) of log-transformed change from baseline at Day 3 were based on adjusted geometric mean. Natural log-transformed change from baseline in FPG was analyzed using mixed effects model with country, treatment as fixed effect and log-transformed baseline as covariate. Placebo is the reference; the active drug group is the test.||107.73|92.30|
72408809|NCT01469065|144326256|SUPERIORITY_OR_OTHER||Test-to-Reference Ratio (%) at Day 3|94.49|||||TWO_SIDED|90.0|87.53|102.1||||||Test-to-Reference ratio of log-transformed change from baseline and 90% confidence interval (CI) of log-transformed change from baseline at Day 3 were based on adjusted geometric mean. Natural log-transformed change from baseline in FPG was analyzed using mixed effects model with country, treatment as fixed effect and log-transformed baseline as covariate. Placebo is the reference; the active drug group is the test.||102.10|87.53|
72408810|NCT01469065|144326256|SUPERIORITY_OR_OTHER||Test-to-Reference Ratio (%) at Day 6|93.43|||||TWO_SIDED|90.0|86.5|100.91||||||Test-to-Reference ratio of log-transformed change from baseline and 90% confidence interval (CI) of log-transformed change from baseline at Day 6 were based on adjusted geometric mean. Natural log-transformed change from baseline in FPG was analyzed using mixed effects model with country, treatment as fixed effect and log-transformed baseline as covariate. Placebo is the reference; the active drug group is the test.||100.91|86.50|
72536309|NCT03539952|144602201|NON_INFERIORITY|The primary efficacy analysis utilized the serum NCC values from all study visits that were analyzed using a restricted maximum likelihood based general linear model for correlated data. The correlation due to repeated measures was modeled by specifying the variance covariance matrix. Considering a comparison of means in both treatment arms (D-penicillamine minus TETA 4HCl) at the 1-sided 2.5% level of Type 1 error, a non-inferiority margin of 50 μg/L was used.|Mean Difference (Final Values)|-9.2|STANDARD_ERROR_OF_MEAN|7.49|||TWO_SIDED|||||||||The primary endpoint was the assessment of the non-inferiority of TETA 4HCl in relation to D-penicillamine. The non-inferiority assessment was made on the basis of the mean serum NCC level at Week 36.||||
72536310|NCT01977482|144602219|SUPERIORITY_OR_OTHER||E0 (g/dL)|-0.664|||||TWO_SIDED|95.0|-0.96|-0.387|||||Posterior median and 95% credibility intervals were estimated using Bayesian methods.|||-0.387|-0.960|
72573283|NCT03433755|144673215|SUPERIORITY||Treatment difference|-55.69|STANDARD_ERROR_OF_MEAN|3.67|<|0.0001|TWO_SIDED|95.0|-62.98|-48.41||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit as covariates.|Treatment difference = Evolocumab Q2W - Placebo Q2W|||-48.41|-62.98|< 0.0001
72408811|NCT01469065|144326256|SUPERIORITY_OR_OTHER||Test-to-Reference Ratio (%) at Day 6|92.71|||||TWO_SIDED|90.0|85.81|100.15||||||Test-to-Reference ratio of log-transformed change from baseline and 90% confidence interval (CI) of log-transformed change from baseline at Day 6 were based on adjusted geometric mean. Natural log-transformed change from baseline in FPG was analyzed using mixed effects model with country, treatment as fixed effect and log-transformed baseline as covariate. Placebo is the reference; the active drug group is the test.||100.15|85.81|
72408812|NCT01469065|144326256|SUPERIORITY_OR_OTHER||Test-to-Reference Ratio (%) at Day 6|94.08|||||TWO_SIDED|90.0|87.08|101.64||||||Test-to-Reference ratio of log-transformed change from baseline and 90% confidence interval (CI) of log-transformed change from baseline at Day 6 were based on adjusted geometric mean. Natural log-transformed change from baseline in FPG was analyzed using mixed effects model with country, treatment as fixed effect and log-transformed baseline as covariate. Placebo is the reference; the active drug group is the test.||101.64|87.08|
72408813|NCT01469065|144326256|SUPERIORITY_OR_OTHER||Test-to-Reference Ratio (%) at Day 6|87.74|||||TWO_SIDED|90.0|81.2|94.81||||||Test-to-Reference ratio of log-transformed change from baseline and 90% confidence interval (CI) of log-transformed change from baseline at Day 6 were based on adjusted geometric mean. Natural log-transformed change from baseline in FPG was analyzed using mixed effects model with country, treatment as fixed effect and log-transformed baseline as covariate. Placebo is the reference; the active drug group is the test.||94.81|81.20|
72536311|NCT01977482|144602219|SUPERIORITY_OR_OTHER||ED50 (milligrams[mg])|33.531|||||TWO_SIDED|95.0|15.566|48.948|||||Posterior median and 95% credibility intervals were estimated using Bayesian methods.|||48.948|15.566|
72536312|NCT01977482|144602219|SUPERIORITY_OR_OTHER||Emax (g/dL)|5.234||||||95.0|2.691|7.94|||||Posterior median and 95% credibility intervals were estimated using Bayesian methods.|||7.940|2.691|
72536313|NCT01977482|144602219|SUPERIORITY_OR_OTHER||Gamma|1.145|||||TWO_SIDED|95.0|0.748|1.738|||||Posterior median and 95% credibility intervals were estimated using Bayesian methods.|||1.738|0.748|
72536314|NCT01977482|144602219|SUPERIORITY_OR_OTHER||Var|1.012|||||TWO_SIDED|95.0|0.84|1.234|||||Posterior median and 95% credibility intervals were estimated using Bayesian methods.|||1.234|0.840|
72536315|NCT01977482|144602219|SUPERIORITY_OR_OTHER||Alpha|-0.206|||||TWO_SIDED|95.0|-0.397|-0.014|||||Posterior median and 95% credibility intervals were estimated using Bayesian methods.|||-0.014|-0.397|
72536316|NCT01977482|144602219|SUPERIORITY_OR_OTHER||Minimally Effective Dose (MED) (mg)|0.418|||||TWO_SIDED|95.0|0.0|2.342|||||Posterior median and 95% credibility intervals were estimated using Bayesian methods.|||2.342|0.000|
72536317|NCT01977482|144602219|SUPERIORITY_OR_OTHER||Dose that achieves a change of -0.25g/dL|2.423|||||TWO_SIDED|95.0|0.0|4.15|||||Posterior median and 95% credibility intervals were estimated using Bayesian methods.|||4.150|0.000|
72536318|NCT01977482|144602219|SUPERIORITY_OR_OTHER||Target Dose (TD) (mg)|4.406|||||TWO_SIDED|95.0|2.544|5.995|||||Posterior median and 95% credibility intervals were estimated using Bayesian methods.|||5.995|2.544|
72536319|NCT01977482|144602219|SUPERIORITY_OR_OTHER||Dose that achieves a change of 0.25 g/dL|6.43|||||TWO_SIDED|95.0|4.698|8.01|||||Posterior median and 95% credibility intervals were estimated using Bayesian methods.|||8.010|4.698|
72536320|NCT01977482|144602219|SUPERIORITY_OR_OTHER||Dose that achieves a change of 0.5 g/dL|8.542|||||TWO_SIDED|95.0|6.931|10.523|||||Posterior median and 95% credibility intervals were estimated using Bayesian methods.|||10.523|6.931|
72536321|NCT01977482|144602219|SUPERIORITY_OR_OTHER||Dose that achieves a change of 0.75 g/dL|10.8|||||TWO_SIDED|95.0|9.024|14.004|||||Posterior median and 95% credibility intervals were estimated using Bayesian methods.|||14.004|9.024|
72536322|NCT01977482|144602219|SUPERIORITY_OR_OTHER||Dose that achieves a change of 1 g/dL|13.248|||||TWO_SIDED|95.0|10.891|18.916|||||Posterior median and 95% credibility intervals were estimated using Bayesian methods.|||18.916|10.891|
72536323|NCT05554471|144602253|SUPERIORITY||||||<|0.001|||||||t-test, 1 sided|||Hypothesis: the time to ambulation for the subjects using the MYNX CONTROL™ Venous VCD was significantly less than for those where manual compression was used.||||<0.001
72536324|NCT05554471|144602254|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||Hypothesis: the time to hemostasis for the MYNX CONTROL™ Venous VCD device is at least 5 minutes less than manual compression.||||<0.001
72536325|NCT05554471|144602256|SUPERIORITY||||||<|0.001|||||||t-test, 1 sided|||Hypothesis: The time to discharge eligibility for the subjects using the MYNX CONTROL™ Venous VCD was significantly less than for those where manual compression was used||||<0.001
72536326|NCT00710840|144602280|SUPERIORITY_OR_OTHER|||||||0.07|TWO_SIDED|||||Difference in the change from Preop to 4 weeks Postop|t-test, 2 sided|||The primary outcome, difference in quadriceps torque between intervention (TKA Min) and Control TKA at 4 weeks, was tested using an analysis of covariance model. Confirmatory measures were evaluated at 4 and 12 weeks after surgery in the same way. Baseline characteristics of the treatment groups were compared using 2-sample t tests for continuous measures or a χ2 test for independent proportions for categorical measures. A 2-sided α level of .05 was designated for statistical significance.||||0.07
72536327|NCT00710840|144602281|SUPERIORITY_OR_OTHER|||||||0.92|TWO_SIDED|||||Difference in the change from Preop to 4 weeks Postop|t-test, 2 sided|||||||0.92
72536328|NCT00710840|144602282|SUPERIORITY_OR_OTHER|||||||0.48|TWO_SIDED|||||Difference in the change from Preop to 4 weeks Postop|t-test, 2 sided|||||||0.48
72536329|NCT00710840|144602283|SUPERIORITY_OR_OTHER|||||||0.41|TWO_SIDED|||||Difference in the change from Preop to 4 weeks Postop|t-test, 2 sided|||||||0.41
72536330|NCT01939834|144602292|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
72536331|NCT00795210|144602301|SUPERIORITY_OR_OTHER|||||||0.01||95.0|||||Kruskal-Wallis|||Kruskal-Wallis Test for overall difference between groups||||0.01
72536332|NCT00795210|144602302|SUPERIORITY_OR_OTHER|||||||0.42||95.0|||||ANOVA|||||||0.42
72536333|NCT03504839|144602304|SUPERIORITY||||||<|0.01|||||||ANOVA|||||||<0.01
72536334|NCT02074982|144602321|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.85|||<|0.0001|TWO_SIDED|95.0|2.01|4.02|||Regression, Logistic|||||4.02|2.01|<0.0001
72536335|NCT00566969|144602339|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|A hierarchical linear model was used to account for unequal variance and covariance structures across time.||||||0.1|||||||ANOVA|||||||.10
72536336|NCT00471237|144602341|SUPERIORITY||Mean Difference (Net)|0.29|STANDARD_ERROR_OF_MEAN|0.55||0.59|TWO_SIDED|95.0|-0.78|1.37|||ANOVA|Each dose of ronacaleret was deemed significantly different from placebo if the Hommel-adjusted p-value was \<0.044 at Month 12.||||1.37|-0.78|0.590
72536337|NCT00471237|144602341|SUPERIORITY||Mean Difference (Net)|1.36|STANDARD_ERROR_OF_MEAN|0.55||0.028|TWO_SIDED|95.0|0.28|2.44|||ANOVA|Each dose of ronacaleret was deemed significantly different from placebo if the Hommel-adjusted p-value was \<0.044 at Month 12||||2.44|0.28|0.028
72536338|NCT00471237|144602341|SUPERIORITY||Mean Difference (Net)|1.58|STANDARD_ERROR_OF_MEAN|0.54||0.011|TWO_SIDED|95.0|0.51|2.65|||ANOVA|Each dose of ronacaleret was deemed significantly different from placebo if the Hommel-adjusted p-value was \<0.044 at Month 12.||||2.65|0.51|0.011
72536339|NCT00471237|144602341|SUPERIORITY||Mean Difference (Net)|1.6|STANDARD_ERROR_OF_MEAN|0.55||0.012|TWO_SIDED|95.0|0.51|2.69|||ANOVA|Each dose of ronacaleret was deemed significantly different from placebo if the Hommel-adjusted p-value was \<0.044 at Month 12.||||2.69|0.51|0.012
72536340|NCT00471237|144602349|SUPERIORITY||Mean Difference (Net)|-0.45|STANDARD_ERROR_OF_MEAN|0.47||0.68|TWO_SIDED|95.0|-1.38|0.48|||ANOVA|Each dose of ronacaleret was deemed significantly different from placebo if the Hommel-adjusted p-value was \<0.006 at Month 6.||||0.48|-1.38|0.680
72408814|NCT01469065|144326256|SUPERIORITY_OR_OTHER||Test-to-Reference Ratio (%) at Day 10|96.91|||||TWO_SIDED|90.0|89.72|104.67||||||Test-to-Reference ratio of log-transformed change from baseline and 90% confidence interval (CI) of log-transformed change from baseline at Day 10 were based on adjusted geometric mean. Natural log-transformed change from baseline in FPG was analyzed using mixed effects model with country, treatment as fixed effect and log-transformed baseline as covariate. Placebo is the reference; the active drug group is the test.||104.67|89.72|
72408815|NCT01469065|144326256|SUPERIORITY_OR_OTHER||Test-to-Reference Ratio (%) at Day 10|96.05|||||TWO_SIDED|90.0|88.9|103.76||||||Test-to-Reference ratio of log-transformed change from baseline and 90% confidence interval (CI) of log-transformed change from baseline at Day 10 were based on adjusted geometric mean. Natural log-transformed change from baseline in FPG was analyzed using mixed effects model with country, treatment as fixed effect and log-transformed baseline as covariate. Placebo is the reference; the active drug group is the test.||103.76|88.90|
72408816|NCT01469065|144326256|SUPERIORITY_OR_OTHER||Test-to-Reference Ratio (%) at Day 10|99.63|||||TWO_SIDED|90.0|92.21|107.64||||||Test-to-Reference ratio of log-transformed change from baseline and 90% confidence interval (CI) of log-transformed change from baseline at Day 10 were based on adjusted geometric mean. Natural log-transformed change from baseline in FPG was analyzed using mixed effects model with country, treatment as fixed effect and log-transformed baseline as covariate. Placebo is the reference; the active drug group is the test.||107.64|92.21|
72408817|NCT01469065|144326256|SUPERIORITY_OR_OTHER||Test-to-Reference Ratio (%) at Day 10|94.5|||||TWO_SIDED|90.0|87.46|102.11||||||Test-to-Reference ratio of log-transformed change from baseline and 90% confidence interval (CI) of log-transformed change from baseline at Day 10 were based on adjusted geometric mean. Natural log-transformed change from baseline in FPG was analyzed using mixed effects model with country, treatment as fixed effect and log-transformed baseline as covariate. Placebo is the reference; the active drug group is the test.||102.11|87.46|
72408818|NCT01469065|144326256|SUPERIORITY_OR_OTHER||Test-to-Reference Ratio (%) at Day 14|86.75|||||TWO_SIDED|90.0|80.32|93.69||||||Test-to-Reference ratio of log-transformed change from baseline and 90% confidence interval (CI) of log-transformed change from baseline at Day 14 were based on adjusted geometric mean. Natural log-transformed change from baseline in FPG was analyzed using mixed effects model with country, treatment as fixed effect and log-transformed baseline as covariate. Placebo is the reference; the active drug group is the test.||93.69|80.32|
72408819|NCT01469065|144326256|SUPERIORITY_OR_OTHER||Test-to-Reference Ratio (%) at Day 14|87.87|||||TWO_SIDED|90.0|81.34|94.93||||||Test-to-Reference ratio of log-transformed change from baseline and 90% confidence interval (CI) of log-transformed change from baseline at Day 14 were based on adjusted geometric mean. Natural log-transformed change from baseline in FPG was analyzed using mixed effects model with country, treatment as fixed effect and log-transformed baseline as covariate. Placebo is the reference; the active drug group is the test.||94.93|81.34|
72408820|NCT01469065|144326256|SUPERIORITY_OR_OTHER||Test-to-Reference Ratio (%) at Day 14|91.35|||||TWO_SIDED|90.0|84.55|98.7||||||Test-to-Reference ratio of log-transformed change from baseline and 90% confidence interval (CI) of log-transformed change from baseline at Day 14 were based on adjusted geometric mean. Natural log-transformed change from baseline in FPG was analyzed using mixed effects model with country, treatment as fixed effect and log-transformed baseline as covariate. Placebo is the reference; the active drug group is the test.||98.70|84.55|
72536341|NCT00471237|144602349|SUPERIORITY||Mean Difference (Net)|0.95|STANDARD_ERROR_OF_MEAN|0.48||0.192|TWO_SIDED|95.0|0.01|1.89|||ANOVA|Each dose of ronacaleret was deemed significantly different from placebo if the Hommel-adjusted p-value was \<0.006 at Month 6.||||1.89|0.01|0.192
72408821|NCT01469065|144326256|SUPERIORITY_OR_OTHER||Test-to-Reference Ratio (%) at Day 14|88.6|||||TWO_SIDED|90.0|82.0|95.74||||||Test-to-Reference ratio of log-transformed change from baseline and 90% confidence interval (CI) of log-transformed change from baseline at Day 14 were based on adjusted geometric mean. Natural log-transformed change from baseline in FPG was analyzed using mixed effects model with country, treatment as fixed effect and log-transformed baseline as covariate. Placebo is the reference; the active drug group is the test.||95.74|82.00|
72408822|NCT01469065|144326256|SUPERIORITY_OR_OTHER||Test-to-Reference Ratio (%) at Day 15|90.45|||||TWO_SIDED|90.0|83.75|97.69||||||Test-to-Reference ratio of log-transformed change from baseline and 90% confidence interval (CI) of log-transformed change from baseline at Day 15 were based on adjusted geometric mean. Natural log-transformed change from baseline in FPG was analyzed using mixed effects model with country, treatment as fixed effect and log-transformed baseline as covariate. Placebo is the reference; the active drug group is the test.||97.69|83.75|
72536342|NCT00471237|144602349|SUPERIORITY||Mean Difference (Net)|-0.19|STANDARD_ERROR_OF_MEAN|0.47||0.68|TWO_SIDED|95.0|-1.12|0.73|||ANOVA|Each dose of ronacaleret was deemed significantly different from placebo if the Hommel-adjusted p-value was \<0.006 at Month 6.||||0.73|-1.12|0.680
72536343|NCT00471237|144602349|SUPERIORITY||Mean Difference (Net)|0.35|STANDARD_ERROR_OF_MEAN|0.48||0.68|TWO_SIDED|95.0|-0.59|1.29|||ANOVA|Each dose of ronacaleret was deemed significantly different from placebo if the Hommel-adjusted p-value was \<0.006 at Month 6.||||1.29|-0.59|0.680
72536344|NCT00471237|144602350|SUPERIORITY||Mean Difference (Net)|-0.68|STANDARD_ERROR_OF_MEAN|0.33||0.037|TWO_SIDED|95.0|-1.32|-0.04|||ANOVA|||Total Hip aBMD, Month 6||-0.04|-1.32|0.037
72536345|NCT00471237|144602350|SUPERIORITY||Mean Difference (Net)|-0.79|STANDARD_ERROR_OF_MEAN|0.33||0.017|TWO_SIDED|95.0|-1.43|-0.14|||ANOVA|||Total Hip aBMD, Month 6||-0.14|-1.43|0.017
72536346|NCT00471237|144602350|SUPERIORITY||Mean Difference (Net)|-1.28|STANDARD_ERROR_OF_MEAN|0.32||0|TWO_SIDED|95.0|-1.92|-0.64|||ANOVA|||Total Hip aBMD, Month 6||-0.64|-1.92|0.000
72536347|NCT00471237|144602350|SUPERIORITY||Mean Difference (Net)|-1.3|STANDARD_ERROR_OF_MEAN|0.33||0|TWO_SIDED|95.0|-1.95|-0.65|||ANOVA|||Total Hip aBMD, Month 6||-0.65|-1.95|0.000
72536348|NCT00471237|144602350|SUPERIORITY||Mean Difference (Net)|-0.89|STANDARD_ERROR_OF_MEAN|0.36||0.015|TWO_SIDED|95.0|-1.61|-0.17|||ANOVA|||Total Hip aBMD, Month 12||-0.17|-1.61|0.015
72536349|NCT00471237|144602350|SUPERIORITY||Mean Difference (Net)|-1.02|STANDARD_ERROR_OF_MEAN|0.37||0.006|TWO_SIDED|95.0|-1.74|-0.3|||ANOVA|||Total Hip aBMD, Month 12||-0.30|-1.74|0.006
72408823|NCT01469065|144326256|SUPERIORITY_OR_OTHER||Test-to-Reference Ratio (%) at Day 15|90.45|||||TWO_SIDED|90.0|84.03|98.08||||||Test-to-Reference ratio of log-transformed change from baseline and 90% confidence interval (CI) of log-transformed change from baseline at Day 15 were based on adjusted geometric mean. Natural log-transformed change from baseline in FPG was analyzed using mixed effects model with country, treatment as fixed effect and log-transformed baseline as covariate. Placebo is the reference; the active drug group is the test.||98.08|84.03|
72408824|NCT01469065|144326256|SUPERIORITY_OR_OTHER||Test-to-Reference Ratio (%) at Day 15|94.75|||||TWO_SIDED|90.0|87.69|102.34||||||Test-to-Reference ratio of log-transformed change from baseline and 90% confidence interval (CI) of log-transformed change from baseline at Day 15 were based on adjusted geometric mean. Natural log-transformed change from baseline in FPG was analyzed using mixed effects model with country, treatment as fixed effect and log-transformed baseline as covariate. Placebo is the reference; the active drug group is the test.||102.34|87.69|
72408825|NCT01469065|144326256|SUPERIORITY_OR_OTHER||Test-to-Reference Ratio (%) at Day 15|93.18|||||TWO_SIDED|90.0|86.17|100.77||||||Test-to-Reference ratio of log-transformed change from baseline and 90% confidence interval (CI) of log-transformed change from baseline at Day 15 were based on adjusted geometric mean. Natural log-transformed change from baseline in FPG was analyzed using mixed effects model with country, treatment as fixed effect and log-transformed baseline as covariate. Placebo is the reference; the active drug group is the test.||100.77|86.17|
72408826|NCT01469065|144326257|SUPERIORITY_OR_OTHER||Test-to-Reference Ratio (%)|112.83|||||TWO_SIDED|90.0|99.84|127.5||||||Test-to-Reference ratio and 90% confidence interval (CI) were based on adjusted geometric mean. Natural log-transformed change from baseline in Insulin AUC(2-6) (Day 14) was analyzed using ANCOVA with country and treatment as fixed effect and log-transformed baseline as covariate. Placebo is the reference; the active drug group is the test.||127.50|99.84|
72408827|NCT01469065|144326257|SUPERIORITY_OR_OTHER||Test-to-Reference Ratio (%)|102.11|||||TWO_SIDED|90.0|90.78|114.85||||||Test-to-Reference ratio and 90% confidence interval (CI) were based on adjusted geometric mean. Natural log-transformed change from baseline in Insulin AUC(2-6) (Day 14) was analyzed using ANCOVA with country and treatment as fixed effect and log-transformed baseline as covariate. Placebo is the reference; the active drug group is the test.||114.85|90.78|
72536350|NCT00471237|144602350|SUPERIORITY||Mean Difference (Net)|-1.33|STANDARD_ERROR_OF_MEAN|0.36||0|TWO_SIDED|95.0|-2.04|-0.63|||ANOVA|||Total Hip aBMD, Month 12||-0.63|-2.04|0.000
72536351|NCT00471237|144602350|SUPERIORITY||Median Difference (Net)|-1.57|STANDARD_ERROR_OF_MEAN|0.37||0|TWO_SIDED|95.0|-2.3|-0.84|||ANOVA|||Total Hip aBMD, Month 12||-0.84|-2.30|0.000
72536352|NCT03112720|144602365|OTHER||Odds Ratio (OR)|1.5|||<|0.01|TWO_SIDED||||||Chi-squared||||\< 0.01 study terminated because of covid and no meaningfull numbers participated|||<0.01
72536353|NCT02684370|144602369|OTHER||adjusted difference in percentage|70.3|||<|0.001|TWO_SIDED|95.0|64.0|76.7||Cochran-Mantel-Haenszel test adjusted for strata (baseline weight \[≤100 kg vs \>100 kg\] and prior exposure to tumor necrosis factor \[TNF\] antagonists \[0 vs ≥1\]). If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% CI for adjusted difference of 2 treatment groups, calculated by Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.|||76.7|64.0|<0.001
72408828|NCT01469065|144326257|SUPERIORITY_OR_OTHER||Test-to-Reference Ratio (%)|111.04|||||TWO_SIDED|90.0|98.5|125.18||||||Test-to-Reference ratio and 90% confidence interval (CI) were based on adjusted geometric mean. Natural log-transformed change from baseline in Insulin AUC(2-6) (Day 14) was analyzed using ANCOVA with country and treatment as fixed effect and log-transformed baseline as covariate. Placebo is the reference; the active drug group is the test.||125.18|98.50|
72536354|NCT02684370|144602370|OTHER||adjusted difference in percentage|79.9|||<|0.001|TWO_SIDED|95.0|73.5|86.3||Cochran-Mantel-Haenszel test adjusted for strata (baseline weight \[≤100 kg vs \>100 kg\] and prior exposure to TNF antagonists \[0 vs ≥1\]). If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% CI for adjusted difference of 2 treatment groups, calculated by Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.|||86.3|73.5|<0.001
72536355|NCT02684370|144602371|OTHER||adjusted difference in percentage|34.7|||<|0.001|TWO_SIDED|95.0|28.6|40.8||Cochran-Mantel-Haenszel test adjusted for strata (baseline weight \[≤100 kg vs \>100 kg\] and prior exposure to TNF antagonists \[0 vs ≥1\]). If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% CI for adjusted difference of 2 treatment groups, calculated by Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.|||40.8|28.6|<0.001
72536356|NCT02684370|144602372|OTHER||adjusted difference in percentage|35.5|||<|0.001|TWO_SIDED|95.0|30.0|41.0||Cochran-Mantel-Haenszel test adjusted for strata (baseline weight \[≤100 kg vs \>100 kg\] and prior exposure to TNF antagonists \[0 vs ≥1\]). If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% CI for adjusted difference of 2 treatment groups, calculated by Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.|||41.0|30.0|< 0.001
72536357|NCT02684370|144602373|OTHER||adjusted difference in percentage|57.9|||<|0.001|TWO_SIDED|95.0|50.4|65.3||Cochran-Mantel-Haenszel test adjusted for strata (baseline weight \[≤100 kg vs \>100 kg\] and prior exposure to TNF antagonists \[0 vs ≥1\]). If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% CI for adjusted difference of 2 treatment groups, calculated by Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.|||65.3|50.4|< 0.001
72536358|NCT02684370|144602374|OTHER||adjusted difference in percentage|27.1|||<|0.001|TWO_SIDED|95.0|21.2|32.9||Cochran-Mantel-Haenszel test adjusted for strata (baseline weight \[≤100 kg vs \>100 kg\] and prior exposure to TNF antagonists \[0 vs ≥1\]). If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% CI for adjusted difference of 2 treatment groups, calculated by Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.|||32.9|21.2|< 0.001
72536359|NCT02684370|144602375|OTHER||adjusted difference in percentage|33.5|||<|0.001|TWO_SIDED|95.0|22.7|44.3||Cochran-Mantel-Haenszel test adjusted for strata (baseline weight \[≤100 kg vs \>100 kg\] and prior exposure to TNF antagonists \[0 vs ≥1\]). If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% CI for adjusted difference of 2 treatment groups, calculated by Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.|||44.3|22.7|< 0.001
72536360|NCT02684370|144602376|OTHER||adjusted difference in percentage|25.1|||<|0.001|TWO_SIDED|95.0|15.2|35.0||Cochran-Mantel-Haenszel test adjusted for strata (baseline weight \[≤100 kg vs \>100 kg\] and prior exposure to TNF antagonists \[0 vs ≥1\]). If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% CI for adjusted difference of 2 treatment groups, calculated by Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.|||35.0|15.2|< 0.001
72536361|NCT02684370|144602377|OTHER||adjusted difference in percentage|23.8|||<|0.001|TWO_SIDED|95.0|15.5|32.1||Cochran-Mantel-Haenszel test adjusted for strata (baseline weight \[≤100 kg vs \>100 kg\] and prior exposure to TNF antagonists \[0 vs ≥1\]). If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% CI for adjusted difference of 2 treatment groups, calculated by Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.|||32.1|15.5|< 0.001
72536362|NCT02684370|144602378|OTHER||adjusted difference in percentage|22.9|||<|0.001|TWO_SIDED|95.0|14.3|31.6||Cochran-Mantel-Haenszel test adjusted for strata (baseline weight \[≤100 kg vs \>100 kg\] and prior exposure to TNF antagonists \[0 vs ≥1\]). If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% CI for adjusted difference of 2 treatment groups, calculated by Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.|||31.6|14.3|< 0.001
72536363|NCT02684370|144602379|OTHER||adjusted difference in percentage|38.3|||<|0.001|TWO_SIDED|95.0|27.9|48.6||Cochran-Mantel-Haenszel test adjusted for strata (baseline weight \[≤100 kg vs \>100 kg\] and prior exposure to TNF antagonists \[0 vs ≥1\]). If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% CI for adjusted difference of 2 treatment groups, calculated by Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.|P-value calculated according to the Cochran-Mantel-Haenszel test adjusted for baseline weight (≤100 kg vs \>100 kg) and prior exposure to TNF antagonists (0 vs ≥1).||48.6|27.9|< 0.001
72536364|NCT02684370|144602380|OTHER||adjusted difference in percentage|35.1|||<|0.001|TWO_SIDED|95.0|25.7|44.6||Cochran-Mantel-Haenszel test adjusted for strata (baseline weight \[≤100 kg vs \>100 kg\] and prior exposure to TNF\] antagonists \[0 vs ≥1\]). If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% CI for adjusted difference of 2 treatment groups, calculated by Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.|||44.6|25.7|< 0.001
72536365|NCT02684370|144602381|OTHER||adjusted difference in percentage|36.5|||<|0.001|TWO_SIDED|95.0|27.0|45.9||Cochran-Mantel-Haenszel test adjusted for strata (baseline weight \[≤100 kg vs \>100 kg\] and prior exposure to TNF\] antagonists \[0 vs ≥1\]). If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% CI for adjusted difference of 2 treatment groups, calculated by Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.|||45.9|27.0|< 0.001
72536366|NCT02684370|144602382|OTHER||adjusted difference in percentage|17.0|||<|0.001|TWO_SIDED|95.0|7.4|26.6||Cochran-Mantel-Haenszel test adjusted for strata (baseline weight \[≤100 kg vs \>100 kg\] and prior exposure to TNF antagonists \[0 vs ≥1\]). If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% CI for adjusted difference of 2 treatment groups, calculated by Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.|||26.6|7.4|< 0.001
72536367|NCT02684370|144602383|OTHER||adjusted difference in percentage|17.3|||<|0.001|TWO_SIDED|95.0|7.3|27.3||Cochran-Mantel-Haenszel test adjusted for strata (baseline weight \[≤100 kg vs \>100 kg\] and prior exposure to TNF\] antagonists \[0 vs ≥1\]). If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% CI for adjusted difference of 2 treatment groups, calculated by Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.|||27.3|7.3|< 0.001
72536368|NCT02684370|144602384|OTHER||adjusted difference in percentage|23.0|||<|0.001|TWO_SIDED|95.0|11.9|34.0||Cochran-Mantel-Haenszel test adjusted for strata (baseline weight \[≤100 kg vs \>100 kg\] and prior exposure to TNF\] antagonists \[0 vs ≥1\]). If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% CI for adjusted difference of 2 treatment groups, calculated by Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.|||34.0|11.9|< 0.001
72369219|NCT00611026|144248556|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.1||0.0186|TWO_SIDED|95.0|-0.5|0.0|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.|"Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type:~standard error of the mean."|Treatment difference fesoterodine vs Tolterodine ER at Week 4.||-0.0|-0.5|0.0186
72369220|NCT00611026|144248556|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001|TWO_SIDED|95.0|-0.9|-0.4|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.|"Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type:~standard error of the mean."|Treatment difference fesoterodine vs placebo at Week 12.||-0.4|-0.9|<0.0001
72536369|NCT02684370|144602385|OTHER||Mean Difference (Final Values)|-5.765|||<|0.001|TWO_SIDED|95.0|-6.496|-5.035|||van Elteren test|||P-value calculated by the van Elteren test stratified for baseline weight (≤100 kg vs \>100 kg) and prior exposure to TNF antagonists (0 vs ≥1).||-5.035|-6.496|<0.001
72536370|NCT04221373|144602386|OTHER|Mixed-effects model|||||<|0.01||||||Main effect of time|Mixed Models Analysis|F(1, 26) = 117.78||SCIM Total Score||||<0.01
72408829|NCT01469065|144326257|SUPERIORITY_OR_OTHER||Test-to-Reference Ratio (%)|96.73|||||TWO_SIDED|90.0|85.46|109.48||||||Test-to-Reference ratio and 90% confidence interval (CI) were based on adjusted geometric mean. Natural log-transformed change from baseline in Insulin AUC(2-6) (Day 14) was analyzed using ANCOVA with country and treatment as fixed effect and log-transformed baseline as covariate. Placebo is the reference; the active drug group is the test.||109.48|85.46|
72408830|NCT01469065|144326258|SUPERIORITY_OR_OTHER||Test-to-Reference Ratio (%)|107.13|||||TWO_SIDED|90.0|98.69|116.3||||||Test-to-Reference ratio and 90% confidence interval (CI) were based on adjusted geometric mean. Natural log-transformed change from baseline in C-peptide AUC(2-6) (Day 14) was analyzed using ANCOVA with country and treatment as fixed effect and log-transformed baseline as covariate. Placebo is the reference; the active drug group is the test.||116.30|98.69|
72408831|NCT01469065|144326258|SUPERIORITY_OR_OTHER||Test-to-Reference Ratio (%)|92.57|||||TWO_SIDED|90.0|85.26|100.5||||||Test-to-Reference ratio and 90% confidence interval (CI) were based on adjusted geometric mean. Natural log-transformed change from baseline in C-peptide AUC(2-6) (Day 14) was analyzed using ANCOVA with country and treatment as fixed effect and log-transformed baseline as covariate. Placebo is the reference; the active drug group is the test.||100.50|85.26|
72408832|NCT01469065|144326258|SUPERIORITY_OR_OTHER||Test-to-Reference Ratio (%)|96.07|||||TWO_SIDED|90.0|88.51|104.27||||||Test-to-Reference ratio and 90% confidence interval (CI) were based on adjusted geometric mean. Natural log-transformed change from baseline in C-peptide AUC(2-6) (Day 14) was analyzed using ANCOVA with country and treatment as fixed effect and log-transformed baseline as covariate. Placebo is the reference; the active drug group is the test.||104.27|88.51|
72536371|NCT04221373|144602386|OTHER|Mixed-effects model||||||0.03||||||treatment group by time interaction effects|Mixed Models Analysis|F(1,26) = 5.59||SCIM Total Score||||0.03
72536372|NCT04221373|144602386|OTHER|Mixed-effects model||||||0.01||||||treatment group by time interaction effects|Mixed Models Analysis|F(1,26) = 8.02||SCIM R \& S scores||||0.01
72536373|NCT04221373|144602386|OTHER|Mixed-effects model|||||<|0.01||||||Main effect of time|Mixed Models Analysis|F(1, 26) = 72.49||SCIM R \& S scores||||< 0.01
72536374|NCT04221373|144602387|OTHER|Mixed-effects model||||||0.02||||||Treatment group by time interaction effects|Mixed Models Analysis|F(1,26) = 5.82||LEMS||||0.02
72536375|NCT04221373|144602387|OTHER|Mixed-effects model|||||<|0.01||||||Main effect of time|Mixed Models Analysis|F(1, 26) = 33.29||LEMS||||<0.01
72536376|NCT04221373|144602387|OTHER|Mixed-effects model||||||0.04||||||Treatment group by time interaction effects|Mixed Models Analysis|F(1,26) = 4.58||UEMS||||0.04
72536377|NCT04221373|144602387|OTHER|Mixed-effects model|||||<|0.01||||||Main effect of time|Mixed Models Analysis|F(1, 26) = 15.34||UEMS||||<0.01
72536378|NCT04221373|144602387|OTHER|Mixed-effects model|||||<|0.01||||||Treatment group by time interaction effects|Mixed Models Analysis|F(1,26) = 8.06||TMS||||<0.01
72536379|NCT04221373|144602387|OTHER|TMS|||||<|0.01||||||Main effect of time|Mixed Models Analysis|F(1,26) = 38.91||||||<0.01
72536380|NCT04221373|144602387|OTHER|Mixed-effects model||||||0.02||||||Treatment group by time interaction effects|Mixed Models Analysis|F(1,21.7) = 6.23||TLTS||||0.02
72536381|NCT04221373|144602387|OTHER|Mixed-effects model||||||0.05||||||Main effect of time|Mixed Models Analysis|F(1 26)=4.14||TLTS||||0.05
72408833|NCT01469065|144326258|SUPERIORITY_OR_OTHER||Test-to-Reference Ratio (%)|91.7|||||TWO_SIDED|90.0|84.38|99.65||||||Test-to-Reference ratio and 90% confidence interval (CI) were based on adjusted geometric mean. Natural log-transformed change from baseline in C-peptide AUC(2-6) (Day 14) was analyzed using ANCOVA with country and treatment as fixed effect and log-transformed baseline as covariate. Placebo is the reference; the active drug group is the test.||99.65|84.38|
72408834|NCT00799617|144326281|SUPERIORITY||Mean Difference (Net)|0.58|||<|0.001|TWO_SIDED|95.0|0.38|0.78||The p value for the treatment effect was determined with the use of a linear mixed model with a random effect for participant.|Mixed Models Analysis|Adjustment for balancing factors: baseline testosterone, age, site, trial participation, use of antidepressants, use of PDE5 inhibitors||||0.78|0.38|<0.001
72536382|NCT04221373|144602388|OTHER|Mixed-effects model||||||0.485||||||Treatment group-by-time interaction effect|Mixed Models Analysis|F(1, 21) = 0.51||Average worst pain intensity||||0.485
72536383|NCT04221373|144602388|OTHER|Mixed-effects model||||||0||||||Main effect of time|Mixed Models Analysis|F(1, 21) = 26.71||Average worst pain intensity||||0.000
72536384|NCT04221373|144602388|OTHER|Mixed-effects model||||||0.832||||||Treatment group-by-time interaction effect|Mixed Models Analysis|F(1, 21) = 0.05||Worst pain interference with day-to-day activities||||0.832
72536385|NCT04221373|144602388|OTHER|Mixed-effects model||||||0.033||||||Main effect of time|Mixed Models Analysis|F(1, 21) = 5.21||Worst pain interference with day-to-day activities||||0.033
72536386|NCT04221373|144602388|OTHER|Mixed-effects model||||||0.692||||||Treatment group-by-time interaction effect|Mixed Models Analysis|F(1, 42) = 0.16||Worst pain interference with overall mood||||0.692
72536387|NCT04221373|144602388|OTHER|Mixed-effects model||||||0.005||||||Main effect of time|Mixed Models Analysis|F(1, 42) = 8.65||Worst pain interference with overall mood||||0.005
72536388|NCT04221373|144602388|OTHER|Mixed-effects model||||||0.946||||||Treatment group-by-time interaction effect|Mixed Models Analysis|F(1,21) = 0.01||Worst pain interfered with sleep||||0.946
72536389|NCT04221373|144602388|OTHER|Mixed-effects model||||||0.0002||||||Main effect of time|Mixed Models Analysis|F(1,21) = 11.94||Worst pain interference with sleep||||0.0002
72536390|NCT04221373|144602389|SUPERIORITY|||||||0.554|||||||Chi-squared|X\^2 (1, N = 23) = 0.35||Baseline||||0.554
72536391|NCT04221373|144602389|SUPERIORITY|||||||0.949|||||||Chi-squared|X\^2 (1, N = 23) = 0.004||discharge from acute inpatient rehabilitation (average 2-3 weeks)||||0.949
72573284|NCT03433755|144673215|SUPERIORITY||Treatment difference|-51.21|STANDARD_ERROR_OF_MEAN|3.45|<|0.0001|TWO_SIDED|95.0|-58.06|-44.37||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit as covariates.|Treatment difference = Evolocumab QM - Placebo QM|||-44.37|-58.06|< 0.0001
72573285|NCT03433755|144673216|SUPERIORITY||Treatment difference|-42.74|STANDARD_ERROR_OF_MEAN|2.68|<|0.0001|TWO_SIDED|95.0|-48.06|-37.41||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit as covariates.|Treatment difference = Evolocumab Q2W - Placebo Q2W|||-37.41|-48.06|< 0.0001
72408835|NCT00799617|144326282|SUPERIORITY||Odds Ratio (OR)|1.42||||0.2|TWO_SIDED|95.0|0.83|2.45||The P value for the treatment effect was determined with the use of a logistic mixed model with a random effect for participant for dichotomous outcomes and a linear mixed model with a random effect for participant for continuous outcomes.|Mixed Models Analysis|||The treatment effect for dichotomous outcomes is the odds ratio for achieving the outcome versus not achieving the outcome among men assigned to testosterone versus those assigned to placebo.||2.45|0.83|0.20
72408836|NCT00799617|144326283|SUPERIORITY||Odds Ratio (OR)|1.23||||0.3|TWO_SIDED|95.0|0.83|1.84||The p value for the treatment effect was determined with the use of a logistic mixed model with a random effect for participant for dichotomous outcomes and a linear mixed model with a random effect for participant for continuous outcomes.|Mixed Models Analysis|||||1.84|0.83|0.30
72408837|NCT00799617|144326284|SUPERIORITY||Mean Difference (Final Values)|41.0||||0.003|TWO_SIDED|95.0|14.0|67.0||Determined by a linear mixed model with all balancing factors and baseline outcome value as covariates and a random effect for participant.|Regression, Linear||Mean difference in change from baseline for participants assigned to testosterone v. placebo, with adjustment for balancing factors: baseline testosterone, age, site, trial participation, use of antidepressants, PDE5 inhibitors, baseline outcome.|||67|14|.003
72536392|NCT00627094|144602415|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.73||||0.0438|TWO_SIDED|95.0|1.02|2.96||In order to obtain 90% power to show superiority of Biatain Ibu compared to Biatain, a sample size of 60 pts per group (assuming a 15% drop-out rate) was found by simulating data from multi-nomial distributions over time.|Chi-squared|Result based on ITT population (evening). PP-analysis show a strong tendency (not significant) in favour of Biatain Ibu supporting the ITT-analysis||The null hypothesis to be tested was that the distributions of categorical responses were the same.||2.96|1.02|0.0438
72536393|NCT01354015|144602426|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.15|STANDARD_DEVIATION|0.79||0.2539|TWO_SIDED|95.0|||||ANOVA|||All statistical analysis used intent-to-treat methodology and all comparisons used a two-tailed test at the .05 level of significance. Continuous variables are reported as means and standard deviations. W||||0.2539
72626670|NCT02164864|144782250|NON_INFERIORITY|All non-inferiority tests were based on a margin of 1.38.|Hazard Ratio (HR)|0.72|||<|0.0001|TWO_SIDED|95.0|0.58|0.88||P-values for non-inferiority were calculated at a one-sided alpha level of 0.025|Regression, Cox|unstratified Cox proportional hazards model was used and elderly patients outside the USA were excluded|Hazard Ratio (HR) and Wald confidence intervals are derived from a Cox proportional-hazard model|A pre-defined hierarchical testing approach was used. This was the second step in hierarchy. The upper bound of the Wald confidence interval (CI) of the HR of Dabigatran Etexilate 150mg vs Warfarin (one-sided 97.5%) was compared with this noninferiority margin for the testing of non-inferiority||0.88|0.58|<.0001
72536394|NCT04637815|144602437|EQUIVALENCE|t-tests for continuous variables and chi-squared tests for categorical variables|||||||TWO_SIDED|0.0||||Statistical threshold of significance is .05.|t-test, 2 sided||||We also conducted difference in differences (DID) analysis by first constructing measures of difference between follow-up and baseline for each participant for each measure and then comparing the means of these difference measures for each arm.|||
72536395|NCT04637815|144602438|EQUIVALENCE|t-tests for continuous variables and chi-squared tests for categorical variables||||||||||||Statistical threshold of significance is .05.|t-test, 2 sided||||We also conducted difference in differences (DID) analysis by first constructing measures of difference between follow-up and baseline for each participant for each measure and then comparing the means of these difference measures for each arm.|||
72536396|NCT04637815|144602439|EQUIVALENCE|t-tests for continuous variables and chi-squared tests for categorical variables||||||||||||Statistical threshold of significance is .05.|t-test, 2 sided||||We also conducted difference in differences (DID) analysis by first constructing measures of difference between follow-up and baseline for each participant for each measure and then comparing the means of these difference measures for each arm.|||
72536397|NCT04637815|144602440|EQUIVALENCE|t-tests for continuous variables and chi-squared tests for categorical variables||||||||||||Statistical threshold of significance is .05.|t-test, 2 sided||||We also conducted difference in differences (DID) analysis by first constructing measures of difference between follow-up and baseline for each participant for each measure and then comparing the means of these difference measures for each arm.|||
72536398|NCT04637815|144602441|EQUIVALENCE|t-tests for continuous variables and chi-squared tests for categorical variables||||||||||||Statistical threshold of significance is .05.|t-test, 2 sided||||We also conducted difference in differences (DID) analysis by first constructing measures of difference between follow-up and baseline for each participant for each measure and then comparing the means of these difference measures for each arm.|||
72536399|NCT00337727|144602442|SUPERIORITY_OR_OTHER||||||<|0.01||95.0||||Superiority based on 2-sided level of significance of 0.05, based on a logistic regression model that included terms for treatment group, region and gender.|Regression, Logistic|||||||<0.01
72536400|NCT00337727|144602443|SUPERIORITY_OR_OTHER||||||<|0.01||95.0||||Superiority based on 2-sided level of significance of 0.05, based on a logistic regression model that included terms for treatment group, region and gender.|Regression, Logistic|||||||<0.01
72536401|NCT00577031|144602459|SUPERIORITY_OR_OTHER|||||||0.0076|||||||Signed-rank test|||Change from baseline to last visit||||0.0076
72536402|NCT06067191|144602460|OTHER||Difference in Least Square Mean|-312.28||||0.0009|TWO_SIDED|95.0|-489.17|-135.38|||ANCOVA||Analysis was performed using ANCOVA with treatment group as a fixed effect and baseline viral load as the covariate.|||-135.38|-489.17|0.0009
72536403|NCT06067191|144602461|OTHER||Difference in Least Square Mean|-1.45||||0.0047|TWO_SIDED|95.0|-2.43|-0.47|||ANCOVA||Analysis was performed using ANCOVA with treatment group as a fixed effect and baseline viral load as the covariate.|||-0.47|-2.43|0.0047
72536404|NCT06067191|144602462|OTHER||||||<|0.0001|||||||Log Rank|||||||<0.0001
72536405|NCT06067191|144602463|OTHER|||||||0.0051|||||||Log Rank|||||||0.0051
72536406|NCT06067191|144602464|OTHER|||||||0.0077|||||||Log Rank|||||||0.0077
72536407|NCT06067191|144602465|OTHER||Difference in Least Square Mean|-87.4||||0.0268|TWO_SIDED|95.0|-164.3|-10.49|||ANCOVA||Analysis was performed using ANCOVA with treatment group as a fixed effect and baseline viral load as the covariate.|||-10.49|-164.30|0.0268
72536408|NCT06067191|144602466|OTHER||Difference in Least Square Mean|-0.99||||0.0865|TWO_SIDED|95.0|-2.13|0.15|||ANCOVA||Analysis was performed using ANCOVA with treatment group as a fixed effect and baseline viral load as the covariate.|||0.15|-2.13|0.0865
72536409|NCT06067191|144602467|OTHER|||||||0.0008|||||||Log Rank|||||||0.0008
72536410|NCT06067191|144602468|OTHER|||||||0.8579|||||||Log Rank|||||||0.8579
72536411|NCT06067191|144602469|OTHER||Difference in Least Square Mean|-93.95||||0.0658|TWO_SIDED|95.0|-194.26|6.36|||ANCOVA||Analysis was performed using ANCOVA with treatment group as a fixed effect and baseline viral load as the covariate.|||6.36|-194.26|0.0658
72536412|NCT06067191|144602470|OTHER||Difference in Least Square Mean|-93.95||||0.0658|TWO_SIDED|95.0|-194.26|6.36|||ANCOVA||Analysis was performed using ANCOVA with treatment group as a fixed effect and baseline viral load as the covariate.|||6.36|-194.26|0.0658
72536413|NCT06067191|144602471|OTHER||Difference in Least Square Mean|-0.93||||0.203|TWO_SIDED|95.0|-2.38|0.52|||ANCOVA||Analysis was performed using ANCOVA with treatment group as a fixed effect and baseline viral load as the covariate.|||0.52|-2.38|0.2030
72536414|NCT00807040|144602501|OTHER|We tested this hypothesis in an intention-to-treat analysis using a two-tailed Wilcoxon rank-sum test, at a 0.05 alpha level. This analysis accommodated nonignorable missing LVESVI outcomes owing to the death of patients by assigning deceased patients the worst ranks in order on the basis of the time of death. We used multiple imputation for data that were missing for reasons other than death to calculate the 12-month LVESVI on the assumption that the data were missing at random.||||||0.18|||||||Wilcoxon (Mann-Whitney)|||The trial was designed with a power of 90% to detect a between-group difference of 15 ml per square meter in the LVESVI from baseline to 12 months. We assumed a baseline LVESVI of 100 ml per square meter, improvements of 20 ml per square meter in the repair group and 35 ml per square meter in the replacement group, and equal 1-year mortality of 10 to 20% in the two groups. The primary null hypothesis was that there would be no between-group difference in the LVESVI at 12 months.||||0.18
72536415|NCT00807040|144602502|OTHER|We used the log-rank test to compare rates of death from baseline to 2 years.|Hazard Ratio (HR)|0.79||||0.39|TWO_SIDED|95.0|0.46|1.35|||Log Rank|||||1.35|0.46|0.39
72536416|NCT03992261|144602523|OTHER|"Mean, median, SD, minimum/maximum determined for total amount of test article used by each subject in Safety, Evaluable, and PK populations HPA Axis Suppression: Proportion of subjects manifesting laboratory evidence of adrenal suppression at EOS were presented with 95% confidence intervals (CIs) for Evaluable and Safety populations. Descriptive statistics for daily dose of test article were tabulated separately for suppressed and non-suppressed subjects.~PK: Screening, Day 8, Day 15"||||||0.05|||||||ANOVA|||Outcome measure: extent of exposure, HPA axis suppression, and pharmacokinetic analysis.||||0.05
72573286|NCT03433755|144673216|SUPERIORITY||Treatment difference|-44.3|STANDARD_ERROR_OF_MEAN|2.38|<|0.0001|TWO_SIDED|95.0|-49.02|-39.58||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit as covariates.|Treatment difference = Evolocumab QM - Placebo QM|||-39.58|-49.02|< 0.0001
72536417|NCT00769132|144602524|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Two treatments are comparable if the geometric mean ratio is contained within the interval \[0.50-2.00\].|Geometric least-squares mean ratio|1.12||||||90.0|0.9|1.38||||||The endpoint is the urine levels of 11-dTxB2 on Day 7 following a 7 day course of daily dosing in the overall 24 hour collection interval. The point estimate and 90% confidence intervals (CIs) were calculated for the geometric mean ratio (GMR) \[Treatment A/B\] of the urine levels of 11-dTxB2 on Day 7.||1.38|0.9|
72536418|NCT00769132|144602524|SUPERIORITY_OR_OTHER_LEGACY||Geometric least-squares mean ratio|0.87||||||90.0|0.71|1.07||||||||1.07|0.71|
72536419|NCT00769132|144602524|SUPERIORITY_OR_OTHER_LEGACY||Geometric least-squares mean ratio|0.8||||||90.0|0.65|0.98||||||||0.98|0.65|
72536420|NCT00769132|144602524|SUPERIORITY_OR_OTHER_LEGACY||Geometric least-squares mean ratio|0.89||||||90.0|0.72|1.09||||||||1.09|0.72|
72536421|NCT00769132|144602524|SUPERIORITY_OR_OTHER_LEGACY||Geometric least-squares mean ratio|0.91||||||90.0|0.74|1.12||||||||1.12|0.74|
72536422|NCT00769132|144602524|SUPERIORITY_OR_OTHER_LEGACY||Geometric least-squares mean ratio|1.02||||||90.0|0.83|1.25||||||||1.25|0.83|
72536423|NCT00769132|144602525|SUPERIORITY_OR_OTHER_LEGACY||Geometric least-squares mean ratio|1.04||||||90.0|0.92|1.17||||||||1.17|0.92|
72573287|NCT03433755|144673217|SUPERIORITY||Treatment difference|-43.05|STANDARD_ERROR_OF_MEAN|3.05|<|0.0001|TWO_SIDED|95.0|-49.09|-37.0||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit as covariates.|Treatment difference = Evolocumab Q2W - Placebo Q2W|||-37.00|-49.09|< 0.0001
72536424|NCT00769132|144602525|SUPERIORITY_OR_OTHER_LEGACY||Geometric least-squares mean ratio|0.9||||||90.0|0.8|1.01||||||||1.01|0.8|
72536425|NCT00769132|144602525|SUPERIORITY_OR_OTHER_LEGACY||Geometric least-squares mean ratio|0.56||||||90.0|0.49|0.63||||||||0.63|0.49|
72536426|NCT00769132|144602525|SUPERIORITY_OR_OTHER_LEGACY||Geometric least-squares mean ratio|0.58||||||90.0|0.51|0.65||||||||0.65|0.51|
72536427|NCT00769132|144602525|SUPERIORITY_OR_OTHER_LEGACY||Geometric least-squares mean ratio|0.62||||||90.0|0.55|0.7||||||||0.7|0.55|
72536428|NCT00769132|144602525|SUPERIORITY_OR_OTHER_LEGACY||Geometric least-squares mean ratio|0.64||||||90.0|0.57|0.72||||||||0.72|0.57|
72536429|NCT00877799|144602528|SUPERIORITY_OR_OTHER|||||||0.057|||||||t-test, 2 sided|||||||0.057
72536430|NCT00877799|144602529|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
72536431|NCT00877799|144602530|SUPERIORITY_OR_OTHER||||||<|0.01|||||||t-test, 2 sided|||||||<0.01
72536432|NCT01833897|144602556|SUPERIORITY_OR_OTHER||||||<|0.001||||||F1,6.4=161.8,|linear mixed model|||||||<0.001
72536433|NCT01833897|144602557|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
72536434|NCT01833897|144602558|SUPERIORITY_OR_OTHER|||||||0.026|||||||ANOVA|||||||0.026
72536435|NCT01833897|144602559|SUPERIORITY_OR_OTHER|||||||0.011|||||||ANOVA|||||||0.011
72536436|NCT01833897|144602560|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
72536437|NCT00127192|144602577|SUPERIORITY_OR_OTHER||Least-squares Mean Difference|-3.6|||<|0.001||95.0|-4.3|-3.0||Multiplicity among pairwise comparisons of sitagliptin groups against placebo was adjusted by Bonferroni method in post-hoc manner.|Pairwise comparison based on ANCOVA|ANCOVA model with terms of treatment, prior antihyperglycemic medication status and baseline was used for pairwise comparison|ANCOVA model with terms of treatment, prior antihyperglycemic medication status and baseline was used to estimate difference of two groups and its 95% confidence interval|||-3.0|-4.3|<0.001
72536438|NCT00127192|144602577|SUPERIORITY_OR_OTHER||Least-squares Mean Difference|-3.2|||<|0.001||95.0|-3.9|-2.6||Multiplicity among pairwise comparisons of sitagliptin groups against placebo was adjusted by Bonferroni method in post-hoc manner.|Pairwise comparison based on ANCOVA|ANCOVA model with terms of treatment, prior antihyperglycemic medication status and baseline was used for pairwise comparison|ANCOVA model with terms of treatment, prior antihyperglycemic medication status and baseline was used to estimate difference of two groups and its 95% confidence interval|||-2.6|-3.9|<0.001
72536439|NCT00127192|144602577|SUPERIORITY_OR_OTHER||Least-squares Mean Difference|-3.3|||<|0.001||95.0|-3.9|-2.7||Multiplicity among pairwise comparisons of sitagliptin groups against placebo was adjusted by Bonferroni method in post-hoc manner.|Pairwise comparison based on ANCOVA|ANCOVA model with terms of treatment, prior antihyperglycemic medication status and baseline was used for pairwise comparison|ANCOVA model with terms of treatment, prior antihyperglycemic medication status and baseline was used to estimate difference of two groups and its 95% confidence interval|||-2.7|-3.9|<0.001
72536440|NCT00127192|144602577|SUPERIORITY_OR_OTHER||Least-squares Mean Difference|-2.6|||<|0.001||95.0|-3.2|-2.0||Multiplicity among pairwise comparisons of sitagliptin groups against placebo was adjusted by Bonferroni method in post-hoc manner.|Pairwise comparison based on ANCOVA|ANCOVA model with terms of treatment, prior antihyperglycemic medication status and baseline was used for pairwise comparison|ANCOVA model with terms of treatment, prior antihyperglycemic medication status and baseline was used to estimate difference of two groups and its 95% confidence interval|||-2.0|-3.2|<0.001
72536441|NCT00127192|144602578|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Tukeys linear trend test based on ANCOVA|Linear contrast including all groups was tested using ANCOVA model with terms of treatment, prior antihyperglycemic medication status and baseline||||||<0.001
72408838|NCT00799617|144326285|SUPERIORITY||Mean Difference (Final Values)|6.8|||<|0.001|TWO_SIDED|95.0|4.8|8.7||Treatment effect is the mean difference in the change from baseline between testosterone and placebo arms.The P-Value for the significance of the treatment effect was determined by multivariable linear regression adjusted for balancing factors.|Regression, Linear|||||8.7|4.8|<.001
72408839|NCT00799617|144326286|SUPERIORITY||Mean Difference (Net)|-0.07||||0.88|TWO_SIDED|95.0|-0.92|0.79||The estimated difference and P-value were determined by a linear mixed-model with a random effect for participants using outcomes at month 6 and month 12.|Mixed Models Analysis|||"A positive estimated difference indicates greater increases, smaller decreases, or both for the testosterone group compared with the placebo group.~The difference is the mean difference in the change from baseline to 6 months to 12 months in participants allocated to testosterone vs placebo adjusted for balancing factors."||0.79|-0.92|.88
72408840|NCT00799617|144326287|SUPERIORITY|Dichotomous hemoglobin response is an increase of 1g/dL or more from baseline.|Odds Ratio (OR)|31.5||||0.002|TWO_SIDED|95.0|3.7|277.8||The P-value for the significance of the treatment effect was determined by a logistic mixed model with a random intercept for participant.|Mixed Models Analysis|The statistical analysis was intent-to-treat by a logistic mixed effects model adjusted for balancing factors.||||277.8|3.7|.002
72408841|NCT00799617|144326288|SUPERIORITY||Mean Difference (Net)|2.93|||<|0.001|TWO_SIDED|95.0|2.13|3.74||The p value for the treatment effect was determined with the use of a linear mixed model with a random effect for participant.|Mixed Models Analysis|Adjustment for balancing factors: baseline testosterone, age, site, trial participation, use of antidepressants, use of PDE5 inhibitors||||3.74|2.13|<0.001
72408842|NCT00799617|144326289|SUPERIORITY||Median Difference (Net)|2.64|||<|0.001|TWO_SIDED|95.0|1.68|3.61||The p value for the treatment effect was determined with the use of a linear mixed model with a random effect for participant.|Mixed Models Analysis|Adjustment for balancing factors: baseline testosterone, age, site, trial participation, use of antidepressants, use of PDE5 inhibitors||||3.61|1.68|<0.001
72408843|NCT00799617|144326290|SUPERIORITY||Mean Difference (Final Values)|4.09||||0.28|TWO_SIDED|95.0|-3.0|11.18||The P value for the treatment effect was determined with the use of a logistic mixed model with a random effect for participant for dichotomous outcomes and a linear mixed model with a random effect for participant for continuous outcomes.|Mixed Models Analysis|||||11.18|-3.00|0.28
72408844|NCT00799617|144326291|SUPERIORITY||Odds Ratio (OR)|1.34||||0.15|TWO_SIDED|95.0|0.9|2.0||The P value for the treatment effect was determined with the use of a logistic mixed model with a random effect for participant for dichotomous outcomes and a linear mixed model with a random effect for participant for continuous outcomes.|Mixed Models Analysis|||||2.00|0.90|0.15
72536442|NCT00127192|144602578|SUPERIORITY_OR_OTHER||Least-squares Mean Difference|-1.04|||<|0.001||95.0|-1.21|-0.86||No multiplicity adjustment was done between trend test of primary analysis and pairwise comparisons, but the multiplicity among pairwise comparisons of sitagliptin groups against placebo was adjusted by Bonferroni method in post-hoc manner.|Pairwise comparison based on ANCOVA|ANCOVA model with terms of treatment, prior antihyperglycemic medication status and baseline was used for pairwise comparison|ANCOVA model with terms of treatment, prior antihyperglycemic medication status and baseline was used to estimate difference of two groups and its 95% confidence interval|||-0.86|-1.21|<0.001
72536443|NCT00127192|144602578|SUPERIORITY_OR_OTHER||Least-squares Mean Difference|-0.96|||<|0.001||95.0|-1.14|-0.79||No multiplicity adjustment was done between trend test of primary analysis and pairwise comparisons, the multiplicity among pairwise comparisons of sitagliptin groups against placebo was adjusted by Bonferroni method in post-hoc manner.|Pairwise comparison based on ANCOVA|ANCOVA model with terms of treatment, prior antihyperglycemic medication status and baseline was used for pairwise comparison|ANCOVA model with terms of treatment, prior antihyperglycemic medication status and baseline was used to estimate difference of two groups and its 95% confidence interval|||-0.79|-1.14|<0.001
72536444|NCT00127192|144602578|SUPERIORITY_OR_OTHER||Least-squares Mean Difference|-0.99|||<|0.001||95.0|-1.16|-0.82||No multiplicity adjustment was done between trend test of primary analysis and pairwise comparisons, the multiplicity among pairwise comparisons of sitagliptin groups against placebo was adjusted by Bonferroni method in post-hoc manner.|Pairwise comparison based on ANCOVA|ANCOVA model with terms of treatment, prior antihyperglycemic medication status and baseline was used for pairwise comparison|ANCOVA model with terms of treatment, prior antihyperglycemic medication status and baseline was used to estimate difference of two groups and its 95% confidence interval|||-0.82|-1.16|<0.001
72408845|NCT00799617|144326292|SUPERIORITY||Mean Difference (Net)|2.75||||0.03|TWO_SIDED|95.0|0.2|5.29||The P value for the treatment effect was determined with the use of a logistic mixed model with a random effect for participant for dichotomous outcomes and a linear mixed model with a random effect for participant for continuous outcomes.|Mixed Models Analysis|||||5.29|0.20|0.03
72408846|NCT00799617|144326293|SUPERIORITY||Mean Difference (Net)|1.21||||0.06|TWO_SIDED|95.0|-0.04|2.46||The p value for the treatment effect was determined with the use of a logistic mixed model with a random effect for participant for dichotomous outcomes and a linear mixed model with a random effect for participant for continuous outcomes.|Mixed Models Analysis|||||2.46|-0.04|0.06
72408847|NCT00799617|144326294|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.41||||0.03|TWO_SIDED|95.0|0.31|4.5||The p value for the treatment effect was determined with the use of a logistic mixed model with a random effect for participant for dichotomous outcomes and a linear mixed model with a random effect for participant for continuous outcomes.|Mixed Models Analysis|||||4.50|0.31|0.03
72408848|NCT00799617|144326295|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.47||||0.04|TWO_SIDED|95.0|0.02|0.92||The p value for the treatment effect was determined with the use of a logistic mixed model with a random effect for participant for dichotomous outcomes and a linear mixed model with a random effect for participant for continuous outcomes.|Mixed Models Analysis|||||0.92|0.02|0.04
72408849|NCT00799617|144326296|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.49|||<|0.001|TWO_SIDED|95.0|-0.79|-0.19||The p value for the treatment effect was determined with the use of a logistic mixed model with a random effect for participant for dichotomous outcomes and a linear mixed model with a random effect for participant for continuous outcomes.|Treatment Effect|||||-0.19|-0.79|<0.001
72626671|NCT02164864|144782250|SUPERIORITY||Hazard Ratio (HR)|0.52|||<|0.001|TWO_SIDED|95.0|0.42|0.63||Wald 2-sided p-value from (stratified) Cox proportional hazards model|Regression, Cox|The Cox proportional hazard model is stratified by age, non-elderly vs elderly \[\<70 or \>=70 in Japan and \<80 or \>=80 years old elsewhere\].|Hazard Ratio (HR) and Wald confidence intervals are derived from a Cox proportional-hazard model|A pre-defined hierarchical testing approach was used. This was the fourth step in hierarchy.||0.63|0.42|<0.001
72626672|NCT02164864|144782250|SUPERIORITY||Hazard Ratio (HR)|0.72||||0.002|TWO_SIDED|95.0|0.58|0.88||unstratified Cox proportional hazards model was used and elderly patients outside the USA were excluded|Regression, Cox|Wald 2-sided p-value from (unstratified) Cox proportional hazards model||A pre-defined hierarchical testing approach was used. This was the sixth step in hierarchy.|Hazard Ratio (HR) and Wald confidence intervals are derived from a Cox proportional-hazard model|0.88|0.58|0.0020
72626673|NCT02164864|144782251|OTHER||Hazard Ratio (HR)|0.99||||0.9862|TWO_SIDED|95.0|0.25|3.95||Wald 2-sided p-value from (stratified) Cox proportional hazards model|Regression, Cox|The Cox proportional hazard model is stratified by age, non-elderly vs elderly \[\<70 or \>=70 in Japan and \<80 or \>=80 years old elsewhere\].|Hazard Ratio (HR) and Wald confidence intervals are derived from a Cox proportional-hazard model|||3.95|0.25|0.9862
72626674|NCT02164864|144782251|OTHER|Wald 2-sided p-value from (unstratified) Cox proportional hazards model|Hazard Ratio (HR)|1.59||||0.5277|TWO_SIDED|95.0|0.38|6.64|||Regression, Cox|unstratified Cox proportional hazards model was used and elderly patients outside the USA were excluded from|Hazard Ratio (HR) and Wald confidence intervals are derived from a Cox proportional-hazard model|||6.64|0.38|0.5277
72408850|NCT00799617|144326297|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.72||||0.004|TWO_SIDED|95.0|-1.2|-0.23||The p value for the treatment effect was determined with the use of a logistic mixed model with a random effect for participant for dichotomous outcomes and a linear mixed model with a random effect for participant for continuous outcomes.|Treatment Effect|||||-0.23|-1.20|0.004
72536445|NCT00127192|144602578|SUPERIORITY_OR_OTHER||Least-squares Mean Difference|-0.69|||<|0.001||95.0|-0.85|-0.52||No multiplicity adjustment was done between trend test of primary analysis and pairwise comparisons, the multiplicity among pairwise comparisons of sitagliptin groups against placebo was adjusted by Bonferroni method in post-hoc manner.|Pairwise comparison based on ANCOVA|ANCOVA model with terms of treatment, prior antihyperglycemic medication status and baseline was used for pairwise comparison|ANCOVA model with terms of treatment, prior antihyperglycemic medication status and baseline was used to estimate difference of two groups and its 95% confidence interval|||-0.52|-0.85|<0.001
72626675|NCT02164864|144782252|OTHER||Hazard Ratio (HR)|1.06||||0.8853|TWO_SIDED|95.0|0.5|2.25||Wald 2-sided p-value from (stratified) Cox proportional hazards model|Regression, Cox|The Cox proportional hazard model is stratified by age, non-elderly vs elderly \[\<70 or \>=70 in Japan and \<80 or \>=80 years old elsewhere\].|Hazard Ratio (HR) and Wald confidence intervals are derived from a Cox proportional-hazard model|||2.25|0.50|0.8853
72626676|NCT02164864|144782252|OTHER||Hazard Ratio (HR)|0.49||||0.238|TWO_SIDED|95.0|0.15|1.61||Wald 2-sided p-value from (unstratified) Cox proportional hazards model|Regression, Cox|unstratified Cox proportional hazards model was used and elderly patients outside the USA were excluded from|Hazard Ratio (HR) and Wald confidence intervals are derived from a Cox proportional-hazard model|||1.61|0.15|0.2380
72626677|NCT02164864|144782253|OTHER||Hazard Ratio (HR)|1.17||||0.5252|TWO_SIDED|95.0|0.72|1.88||Wald 2-sided p-value from (stratified) Cox proportional hazards model|Regression, Cox|The Cox proportional hazard model is stratified by age, non-elderly vs elderly \[\<70 or \>=70 in Japan and \<80 or \>=80 years old elsewhere\].|Hazard Ratio (HR) and Wald confidence intervals are derived from a Cox proportional-hazard model|||1.88|0.72|0.5252
72626678|NCT02164864|144782253|OTHER||Hazard Ratio (HR)|0.84||||0.567|TWO_SIDED|95.0|0.47|1.51||Wald 2-sided p-value from (unstratified) Cox proportional hazards model|Regression, Cox|unstratified Cox proportional hazards model was used and elderly patients outside the USA were excluded from|Hazard Ratio (HR) and Wald confidence intervals are derived from a Cox proportional-hazard model|||1.51|0.47|0.5670
72626679|NCT02164864|144782254|OTHER||Hazard Ratio (HR)|1.12||||0.5579|TWO_SIDED|95.0|0.76|1.65||Wald 2-sided p-value from (stratified) Cox proportional hazards model|Regression, Cox|The Cox proportional hazard model is stratified by age, non-elderly vs elderly \[\<70 or \>=70 in Japan and \<80 or \>=80 years old elsewhere\].|Hazard Ratio (HR) and Wald confidence intervals are derived from a Cox proportional-hazard model|||1.65|0.76|0.5579
72626680|NCT02164864|144782254|OTHER||Hazard Ratio (HR)|0.83||||0.4414|TWO_SIDED|95.0|0.51|1.34||Wald 2-sided p-value from (unstratified) Cox proportional hazards model|Regression, Cox|unstratified Cox proportional hazards model was used and elderly patients outside the USA were excluded|Hazard Ratio (HR) and Wald confidence intervals are derived from a Cox proportional-hazard model|||1.34|0.51|0.4414
72626681|NCT02164864|144782255|OTHER|Wald 2-sided p-value from (stratified) Cox proportional hazards model|Hazard Ratio (HR)|1.51||||0.0861|TWO_SIDED|95.0|0.94|2.41|||Regression, Cox|The Cox proportional hazard model is stratified by age, non-elderly vs elderly \[\<70 or \>=70 in Japan and \<80 or \>=80 years old elsewhere\].|Hazard Ratio (HR) and Wald confidence intervals are derived from a Cox proportional-hazard model|||2.41|0.94|0.0861
72626682|NCT02164864|144782255|OTHER||Hazard Ratio (HR)|1.16||||0.6144|TWO_SIDED|95.0|0.66|2.04||Wald 2-sided p-value from (unstratified) Cox proportional hazards model|Regression, Cox|unstratified Cox proportional hazards model was used and elderly patients outside the USA were excluded from|Hazard Ratio (HR) and Wald confidence intervals are derived from a Cox proportional-hazard model|||2.04|0.66|0.6144
72408851|NCT00799617|144326298|SUPERIORITY||Mean Difference (Final Values)|47.0||||0.006|TWO_SIDED|95.0|13.0|80.0||Determined by linear mixed model with all balancing factors and baseline outcome value as covariates and a random effect for participant.|Regression, Linear||Mean difference in change from baseline for participants assigned to testosterone v. placebo, with adjustment for balancing factors: baseline testosterone, age, site, trial participation, use of antidepressants, PDE5 inhibitors, baseline outcome.|||80|13|.006
72408852|NCT00799617|144326299|SUPERIORITY||Mean Difference (Final Values)|-27.0||||0.31|TWO_SIDED|95.0|-80.0|26.0||Determined by a linear mixed model with all balancing factors and baseline outcome value as covariates and a random effect for participant.|Regression, Linear||Mean difference in change from baseline for participants assigned to testosterone v. placebo, with adjustment for balancing factors: baseline testosterone, age, site, trial participation, use of antidepressants, PDE5 inhibitors, baseline outcome.|||26|-80|.31
72408853|NCT00799617|144326300|SUPERIORITY||Mean Difference (Final Values)|2.9|||<|0.001|TWO_SIDED|95.0|2.1|3.7||"Treatment effect is the mean difference in the change from baseline between testosterone and placebo arms.~The P-Value for the significance of the treatment effect was determined by multivariable linear regression adjusted for balancing factors."|Regression, Linear|||||3.7|2.1|<.001
72408854|NCT00799617|144326301|SUPERIORITY||Mean Difference (Final Values)|4.2|||<|0.001|TWO_SIDED|95.0|3.2|5.3||"Treatment effect is the mean difference in the change from baseline between testosterone and placebo arms.~The P-Value for the significance of the treatment effect was determined by multivariable linear regression adjusted for balancing factors."|Regression, Linear|||||5.3|3.2|<.001
72408855|NCT00799617|144326302|SUPERIORITY||Median Difference (Final Values)|1.5|||<|0.001|TWO_SIDED|95.0|0.9|2.0||"Treatment effect is the mean difference in the change from baseline between testosterone and placebo arms.~The P-Value for the significance of the treatment effect was determined by multivariable linear regression adjusted for balancing factors."|Regression, Linear|||||2.0|0.9|<.001
72408856|NCT00799617|144326303|SUPERIORITY||Mean Difference (Final Values)|1.0|||<|0.001|TWO_SIDED|95.0|0.5|1.5||"Treatment effect is the mean difference in the change from baseline between testosterone and placebo arms.~The P-Value for the significance of the treatment effect was determined by multivariable linear regression adjusted for balancing factors."|Regression, Linear|||||1.5|0.5|<.001
72408857|NCT00799617|144326304|SUPERIORITY||Mean Difference (Final Values)|1.3|||<|0.001|TWO_SIDED|95.0|0.8|1.7|||Regression, Linear|||"Treatment effect is the mean difference in the change from baseline between testosterone and placebo arms.~The P-Value for the significance of the treatment effect was determined by multivariable linear regression adjusted for balancing factors."||1.7|0.8|<.001
72536446|NCT00127192|144602579|SUPERIORITY_OR_OTHER||Least-squares Mean Difference|-23.2|||<|0.001||95.0|-29.8|-16.6||Multiplicity among pairwise comparisons of sitagliptin groups against placebo was adjusted by Bonferroni method in post-hoc manner.|Pairwise comparison based on ANCOVA|ANCOVA model with terms of treatment, prior antihyperglycemic medication status and baseline was used for pairwise comparison|ANCOVA model with terms of treatment, prior antihyperglycemic medication status and baseline was used to estimate difference of two groups and its 95% confidence interval|||-16.6|-29.8|<0.001
72536447|NCT00127192|144602579|SUPERIORITY_OR_OTHER||Least-squares Mean Difference|-20.8|||<|0.001||95.0|-27.4|-14.3||Multiplicity among pairwise comparisons of sitagliptin groups against placebo was adjusted by Bonferroni method in post-hoc manner.|Pairwise comparison based on ANCOVA|ANCOVA model with terms of treatment, prior antihyperglycemic medication status and baseline was used for pairwise comparison|ANCOVA model with terms of treatment, prior antihyperglycemic medication status and baseline was used to estimate difference of two groups and its 95% confidence interval|||-14.3|-27.4|<0.001
72536448|NCT00127192|144602579|SUPERIORITY_OR_OTHER||Least-squares Mean Difference|-17.7|||<|0.001||95.0|-24.2|-11.2||Multiplicity among pairwise comparisons of sitagliptin groups against placebo was adjusted by Bonferroni method in post-hoc manner.|Pairwise comparison based on ANCOVA|ANCOVA model with terms of treatment, prior antihyperglycemic medication status and baseline was used for pairwise comparison|ANCOVA model with terms of treatment, prior antihyperglycemic medication status and baseline was used to estimate difference of two groups and its 95% confidence interval|||-11.2|-24.2|<0.001
72626683|NCT02164864|144782256|OTHER||Hazard Ratio (HR)|1.3||||0.4803|TWO_SIDED|95.0|0.63|2.67||Wald 2-sided p-value from (stratified) Cox proportional hazards model|Regression, Cox|The Cox proportional hazard model is stratified by age, non-elderly vs elderly \[\<70 or \>=70 in Japan and \<80 or \>=80 years old elsewhere\].|Hazard Ratio (HR) and Wald confidence intervals are derived from a Cox proportional-hazard model|||2.67|0.63|0.4803
72536449|NCT00127192|144602579|SUPERIORITY_OR_OTHER||Least-squares Mean Difference|-15.9|||<|0.001||95.0|-22.3|-9.6||Multiplicity among pairwise comparisons of sitagliptin groups against placebo was adjusted by Bonferroni method in post-hoc manner.|Pairwise comparison based on ANCOVA|ANCOVA model with terms of treatment, prior antihyperglycemic medication status and baseline was used for pairwise comparison|ANCOVA model with terms of treatment, prior antihyperglycemic medication status and baseline was used to estimate difference of two groups and its 95% confidence interval|||-9.6|-22.3|<0.001
72408858|NCT00799617|144326305|SUPERIORITY||Mean Difference (Final Values)|7.1|||<|0.001|TWO_SIDED|95.0|5.3|809.0||"Treatment effect is the mean difference in the change from baseline between testosterone and placebo arms.~The P-Value for the significance of the treatment effect was determined by multivariable linear regression adjusted for balancing factors."|Regression, Linear|||||809|5.3|<.001
72408859|NCT00799617|144326306|SUPERIORITY||Mean Difference (Final Values)|8.5|||<|0.001|TWO_SIDED|95.0|6.0|10.9||"Treatment effect is the mean difference in the change from baseline between testosterone and placebo arms.~The P-Value for the significance of the treatment effect was determined by multivariable linear regression adjusted for balancing factors."|Regression, Linear|||||10.9|6.0|<.001
72408860|NCT00799617|144326307|SUPERIORITY||Mean Difference (Final Values)|5.7|||<|0.001|TWO_SIDED|95.0|4.3|7.2||"Treatment effect is the mean difference in the change from baseline between testosterone and placebo arms.~The P-Value for the significance of the treatment effect was determined by multivariable linear regression adjusted for balancing factors."|Regression, Linear|||||7.2|4.3|<.001
72408861|NCT00799617|144326308|SUPERIORITY||Mean Difference (Final Values)|1.8|||<|0.001|TWO_SIDED|95.0|1.1|2.6||"Treatment effect is the mean difference in the change from baseline between testosterone and placebo arms.~The P-Value for the significance of the treatment effect was determined by multivariable linear regression adjusted for balancing factors."|Regression, Linear|||||2.6|1.1|<.001
72408862|NCT00799617|144326309|SUPERIORITY||Mean Difference (Final Values)|1.0||||0.005|TWO_SIDED|95.0|0.3|1.7||"Treatment effect is the mean difference in the change from baseline between testosterone and placebo arms.~The P-Value for the significance of the treatment effect was determined by multivariable linear regression adjusted for balancing factors."|Regression, Linear|||||1.7|0.3|.005
72536450|NCT00077766|144602608|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority with 90% power assuming that the true difference between the RO0503821 group and darbepoetin was not larger than 0.3 g/dL.|Mean Difference (Final Values)|0.18|STANDARD_ERROR_OF_MEAN|0.1162|<|0.0001|TWO_SIDED|95.0|-0.049|0.408||The p-value for the non-inferiority test was derived using ANCOVA.|ANCOVA, CI for difference between groups|Degrees of Freedom : 246|Difference between groups based on the adjusted means derived from the ANCOVA model.|RO0503821 group was compared to darbepoetin alfa group, using analysis of covariance (ANCOVA) with the independent variable as treatment group and Hb at baseline and geographical region as covariates. The test for non-inferiority was based on the lower limit of 2-sided 95% confidence interval (CI) for difference in adjusted mean between 2 groups. If this lower limit was \> or = to -0.75 g/dL, the RO0503821 group was regarded as clinically non-inferior to darbepoetin alfa group, with 90% power.||0.408|-0.049|< 0.0001
72536451|NCT02181075|144602617|SUPERIORITY|||||||0.024||||||Not adjusted for multiple comparisons. A priori threshold \< 0.05|t-test, 2 sided|95% confidence interval (CI)||A paired t-test was used for Part I (Arm 1) only. Analysis only applies to Part I (Arm 1) because only this study arm has matched Post-LTLD (i.e. post-drug alone) and Post-LTLD+FUS biopsy samples obtained from the same liver tumours before and after targeted drug delivery. In Part II of the study design in which drug delivery occurred completely non-invasively, no Post-LTLD tissue sample is obtained and only a single tumour biopsy is obtained following drug delivery (Post-LTLD+FUS).||||0.024
72536452|NCT04150107|144602623|OTHER|Treatment least squares means and change from baseline estimates will be derived using this linear model.|Least mean squares||||<|0.9223|||||||ANCOVA|||Information collected in the daily diaries or via the Continuous Glucose Monitor (CGM) on the final 10 days of treatment will be analyzed using a Repeated Measures Analysis of Covariance with subject as a random effect with each of the 10 days being a single measurement. When analyzing the exogenous insulin variables, the CGM parameters (mean 24 hour glucose value and 24 hour time within 70-180 mg/dL range) and the patient reported carbohydrate intake will be included as covariates.||||<0.9223
72536453|NCT04150107|144602624|OTHER|Treatment least squares means and change from baseline estimates will be derived using this linear model.|||||<|0.8871|||||||ANCOVA|||Information collected in the daily diaries or via the Continuous Glucose Monitor (CGM) on the final 10 days of treatment will be analyzed using a Repeated Measures Analysis of Covariance with subject as a random effect with each of the 10 days being a single measurement. When analyzing the exogenous insulin variables, the CGM parameters (mean 24 hour glucose value and 24 hour time within 70-180 mg/dL range) and the patient reported carbohydrate intake will be included as covariates.||||<0.8871
72573288|NCT03433755|144673217|SUPERIORITY||Treatment difference|-40.42|STANDARD_ERROR_OF_MEAN|2.8|<|0.0001|TWO_SIDED|95.0|-45.98|-34.87||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit as covariates.|Treatment difference = Evolocumab QM - Placebo QM|||-34.87|-45.98|< 0.0001
72573289|NCT03433755|144673218|SUPERIORITY||Treatment difference|87.2|||<|0.0001|TWO_SIDED|95.0|72.6|92.8||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on Cochran Mantel Haenszel (CMH) test adjusted by the stratification factor.|Treatment difference = Evolocumab Q2W - Placebo Q2W|||92.8|72.6|< 0.0001
72573290|NCT03433755|144673218|SUPERIORITY||Treatment difference|91.5|||<|0.0001|TWO_SIDED|95.0|76.9|96.1||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on CMH test adjusted by the stratification factor.|Treatment difference = Evolocumab QM - Placebo QM|||96.1|76.9|< 0.0001
72573291|NCT03433755|144673219|SUPERIORITY||Treatment difference|90.6|||<|0.0001|TWO_SIDED|95.0|76.6|95.6||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on CMH test adjusted by the stratification factor.|Treatment difference = Evolocumab Q2W - Placebo Q2W|||95.6|76.6|< 0.0001
72573292|NCT03433755|144673219|SUPERIORITY||Treatment difference|85.7|||<|0.0001|TWO_SIDED|95.0|68.2|91.9||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on CMH test adjusted by the stratification factor.|Treatment difference = Evolocumab QM - Placebo QM|||91.9|68.2|< 0.0001
72573293|NCT03433755|144673220|SUPERIORITY||Treatment difference|87.0|||<|0.0001|TWO_SIDED|95.0|73.3|93.0||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on CMH test adjusted by the stratification factor.|Treatment difference = Evolocumab Q2W - Placebo Q2W|||93.0|73.3|< 0.0001
72573294|NCT03433755|144673220|SUPERIORITY||Treatment difference|88.7|||<|0.0001|TWO_SIDED|95.0|73.5|94.0||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on CMH test adjusted by the stratification factor.|Treatment difference = Evolocumab QM - Placebo QM|||94.0|73.5|< 0.0001
72573295|NCT03433755|144673221|SUPERIORITY||Treatment difference|82.8|||<|0.0001|TWO_SIDED|95.0|67.8|90.1||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on CMH test adjusted by the stratification factor.|Treatment difference = Evolocumab Q2W - Placebo Q2W|||90.1|67.8|< 0.0001
72573296|NCT03433755|144673221|SUPERIORITY||Treatment difference|82.7|||<|0.0001|TWO_SIDED|95.0|64.8|89.7||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on CMH test adjusted by the stratification factor.|Treatment difference = Evolocumab QM - Placebo QM|||89.7|64.8|< 0.0001
72573297|NCT03433755|144673222|SUPERIORITY||Treatment difference|-48.45|STANDARD_ERROR_OF_MEAN|4.71|<|0.0001|TWO_SIDED|95.0|-57.78|-39.11||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit as covariates.|Treatment difference = Evolocumab Q2W - Placebo Q2W|||-39.11|-57.78|< 0.0001
72536454|NCT04150107|144602625|OTHER|Treatment least squares means and change from baseline estimates will be derived using this linear model.|||||<|0.9641|||||||ANCOVA|||Information collected in the daily diaries or via the Continuous Glucose Monitor (CGM) on the final 10 days of treatment will be analyzed using a Repeated Measures Analysis of Covariance with subject as a random effect with each of the 10 days being a single measurement. When analyzing the exogenous insulin variables, the CGM parameters (mean 24 hour glucose value and 24 hour time within 70-180 mg/dL range) and the patient reported carbohydrate intake will be included as covariates.||||<0.9641
72408863|NCT00799617|144326310|SUPERIORITY||Mean Difference (Final Values)|1.0|||<|0.001|TWO_SIDED|95.0|0.5|1.4||"Treatment effect is the mean difference in the change from baseline between testosterone and placebo arms.~The P-Value for the significance of the treatment effect was determined by multivariable linear regression adjusted for balancing factors."|Regression, Linear|||||1.4|0.5|<.001
72408864|NCT00799617|144326311|SUPERIORITY||Mean Difference (Final Values)|1.2||||0.01|TWO_SIDED|95.0|0.25|2.09||"Treatment effect is the mean difference in the change from baseline between testosterone and placebo arms.~The P-Value for the significance of the treatment effect was determined by multivariable linear regression adjusted for balancing factors."|Regression, Linear|||||2.09|0.25|.01
72408865|NCT00799617|144326312|SUPERIORITY||Mean Difference (Final Values)|0.07||||0.052|TWO_SIDED|95.0|-0.01|1.36||"Treatment effect is the mean difference in the change from baseline between testosterone and placebo arms.~The P-Value for the significance of the treatment effect was determined by multivariable linear regression adjusted for balancing factors."|Regression, Linear|||||1.36|-0.01|.052
72536455|NCT04150107|144602626|OTHER|Treatment least squares means and change from baseline estimates will be derived using this linear model.|||||<|0.7922|||||||ANCOVA|||Information collected in the daily diaries or via the Continuous Glucose Monitor (CGM) on the final 10 days of treatment will be analyzed using a Repeated Measures Analysis of Covariance with subject as a random effect with each of the 10 days being a single measurement. When analyzing the exogenous insulin variables, the CGM parameters (mean 24 hour glucose value and 24 hour time within 70-180 mg/dL range) and the patient reported carbohydrate intake will be included as covariates.||||<0.7922
72536456|NCT04150107|144602627|OTHER|Treatment least squares means and change from baseline estimates will be derived using this linear model.|||||<|0.9898|||||||ANCOVA|||Information collected in the daily diaries or via the Continuous Glucose Monitor (CGM) on the final 10 days of treatment will be analyzed using a Repeated Measures Analysis of Covariance with subject as a random effect with each of the 10 days being a single measurement. When analyzing the exogenous insulin variables, the CGM parameters (mean 24 hour glucose value and 24 hour time within 70-180 mg/dL range) and the patient reported carbohydrate intake will be included as covariates.||||<0.9898
72536457|NCT04150107|144602628|OTHER|Treatment least squares means and change from baseline estimates will be derived using this linear model.|||||<|0.5165|||||||ANCOVA|||Information collected in the daily diaries or via the Continuous Glucose Monitor (CGM) on the final 10 days of treatment will be analyzed using a Repeated Measures Analysis of Covariance with subject as a random effect with each of the 10 days being a single measurement. When analyzing the exogenous insulin variables, the CGM parameters (mean 24 hour glucose value and 24 hour time within 70-180 mg/dL range) and the patient reported carbohydrate intake will be included as covariates.||||<0.5165
72536458|NCT00798707|144602720|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.47||||0.452|TWO_SIDED|95.0|-0.75|1.69||A Hochberg step-up procedure was used to control for the multiplicity associated with multiple active dose arms.|ANCOVA|||An analysis of covariance (ANCOVA) model with treatment and as a factor and the baseline HAM-D17 total score as a covariate was used to compare each DVS SR dose to placebo. The comparison was performed at the 0.05 level overall.||1.69|-0.75|0.452
72536459|NCT00798707|144602720|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.5||||0.016|TWO_SIDED|95.0|0.28|2.72||A Hochberg step-up procedure was used to control for the multiplicity associated with multiple active dose arms.|ANCOVA|||An analysis of covariance (ANCOVA) model with treatment and as a factor and the baseline HAM-D17 total score as a covariate was used to compare each DVS SR dose to placebo. The comparison was performed at the 0.05 level overall.||2.72|0.28|0.016
72536460|NCT00798707|144602721|SUPERIORITY_OR_OTHER|||||||0.16|TWO_SIDED|||||In this case, multiplicity arising from testing key secondary hypotheses in both doses was controlled by a Hochberg step-up procedure. p-Value obtained for the alternative hypothesis of 'Row mean scores differences'.|Cochran-Mantel-Haenszel|||Each DVS SR dose was separately compared to placebo. To control the study-wise type I error rate across the primary and the key secondary endpoints, as well as across the 2 active dose arms, testing of the key secondary hypothesis occurred only when both active doses were superior to placebo on the primary endpoint.||||0.160
72536461|NCT00798707|144602721|SUPERIORITY_OR_OTHER|||||||0.028|TWO_SIDED|||||In this case, multiplicity arising from testing key secondary hypotheses in both doses was controlled by a Hochberg step-up procedure.p-Value obtained for the alternative hypothesis of 'Row mean scores differences'.|Cochran-Mantel-Haenszel|||Each DVS SR dose was separately compared to placebo. To control the study-wise type I error rate across the primary and the key secondary endpoints, as well as across the 2 active dose arms, testing of the key secondary hypothesis occurred only when both active doses were superior to placebo on the primary endpoint.||||0.028
72408866|NCT00799617|144326313|SUPERIORITY||Mean Difference (Final Values)|0.56||||0.27|TWO_SIDED|95.0|-0.45|1.58||"Treatment effect is the mean difference in the change from baseline between testosterone and placebo arms.~The P-Value for the significance of the treatment effect was determined by multivariable linear regression adjusted for balancing factors."|Regression, Linear|||||1.58|-0.45|0.27
72408867|NCT00799617|144326314|SUPERIORITY||Mean Difference (Final Values)|-0.28||||0.24|TWO_SIDED|95.0|-0.76|0.19||The estimated difference and P-value were determined by a linear mixed-model with a random effect for participants using outcomes at month 6 and month 12.|Mixed Models Analysis||The difference is the mean difference in the change from baseline to 6 months to 12 months in participants allocated to testosterone vs placebo adjusted for balancing factors.|A positive estimated difference indicates greater increases, smaller decreases, or both for the testosterone group compared with the placebo group.||0.19|-0.76|.24
72536462|NCT00798707|144602722|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.19||||0.066|TWO_SIDED|95.0|-0.01|0.39|||ANCOVA|||Analysis was conducted using ANCOVA on the change from baseline with treatment as a factor and corresponding baseline value as a covariate.||0.39|-0.01|0.066
72536463|NCT00798707|144602722|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.21||||0.038|TWO_SIDED|95.0|0.01|0.41|||ANCOVA|||Analysis was conducted using ANCOVA on the change from baseline with treatment as a factor and corresponding baseline value as a covariate.||0.41|0.01|0.038
72536464|NCT00798707|144602723|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.0||||0.242|TWO_SIDED|95.0|-0.68|2.68|||ANCOVA|||Analysis was conducted using ANCOVA on the change from baseline with treatment as a factor and corresponding baseline value as a covariate.||2.68|-0.68|0.242
72536465|NCT00798707|144602723|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.06||||0.016|TWO_SIDED|95.0|0.39|3.73|||ANCOVA|||Analysis was conducted using ANCOVA on the change from baseline with treatment as a factor and corresponding baseline value as a covariate.||3.73|0.39|0.016
72536466|NCT00798707|144602724|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.09||||0.802|TWO_SIDED|95.0|-0.62|0.8|||ANCOVA|||Analysis was conducted using ANCOVA on the change from baseline with treatment as a factor and corresponding baseline value as a covariate.||0.80|-0.62|0.802
72536467|NCT00798707|144602724|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.72||||0.048|TWO_SIDED|95.0|0.01|1.43|||ANCOVA|||Analysis was conducted using ANCOVA on the change from baseline with treatment as a factor and corresponding baseline value as a covariate.||1.43|0.01|0.048
72536468|NCT00798707|144602725|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.363||||0.1099|TWO_SIDED|95.0|0.93|1.99|||Regression, Logistic|||Analysis was conducted using a logistic regression model with treatment as a factor and baseline HAM-D17 score as a covariate.||1.99|0.93|0.1099
72536469|NCT00798707|144602725|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.591||||0.0154|TWO_SIDED|95.0|1.09|2.32|||Regression, Logistic|||Analysis was conducted using a logistic regression model with treatment as a factor and baseline HAM-D17 score as a covariate.||2.32|1.09|0.0154
72536470|NCT00798707|144602726|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.878||||0.5929|TWO_SIDED|95.0|0.54|1.41|||Regression, Logistic|||Analysis was conducted using a logistic regression model with treatment as a factor and baseline HAM-D17 score as a covariate.||1.41|0.54|0.5929
72536471|NCT00798707|144602726|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.474||||0.0852|TWO_SIDED|95.0|0.95|2.29|||Regression, Logistic|||Analysis was conducted using a logistic regression model with treatment as a factor and baseline HAM-D17 score as a covariate.||2.29|0.95|0.0852
72536472|NCT00798707|144602727|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.277||||0.2232|TWO_SIDED|95.0|0.86|1.89|||Regression, Logistic|||Analysis was conducted with a logistic regression model with treatment as a factor and baseline MADRS score as a covariate.||1.89|0.86|0.2232
72536473|NCT00798707|144602727|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.827||||0.0022|TWO_SIDED|95.0|1.24|2.69|||Regression, Logistic|||Analysis was conducted with a logistic regression model with treatment as a factor and baseline MADRS score as a covariate.||2.69|1.24|0.0022
72536474|NCT00798707|144602728|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.158||||0.4313|TWO_SIDED|95.0|0.8|1.67|||Regression, Logistic|||Analysis was conducted with a logistic regression model with treatment as a factor.||1.67|0.80|0.4313
72536475|NCT00798707|144602728|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.372||||0.0888|TWO_SIDED|95.0|0.95|1.97|||Regression, Logistic|||Analysis was conducted with a logistic regression model with treatment as a factor.||1.97|0.95|0.0888
72536476|NCT00798707|144602730|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.09||||0.073|TWO_SIDED|95.0|-0.1|2.29|||ANCOVA|||Analysis was conducted using ANCOVA on the change from baseline with treatment as a factor and corresponding baseline value as a covariate for total score.||2.29|-0.10|0.073
72536477|NCT00798707|144602730|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|1.06||||0.078|TWO_SIDED|95.0|-0.12|2.24|||ANCOVA|||Analysis was conducted using ANCOVA on the change from baseline with treatment as a factor and corresponding baseline value as a covariate for total score.||2.24|-0.12|0.078
72536478|NCT00798707|144602730|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3||||0.176|TWO_SIDED|95.0|-0.13|0.73|||ANCOVA|||Analysis was conducted using ANCOVA on the change from baseline with treatment as a factor and corresponding baseline value as a covariate for work/studies component score.||0.73|-0.13|0.176
72536479|NCT00798707|144602730|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.35||||0.109|TWO_SIDED|95.0|-0.08|0.77|||ANCOVA|||Analysis was conducted using ANCOVA on the change from baseline with treatment as a factor and corresponding baseline value as a covariate for work/studies component score.||0.77|-0.08|0.109
72536480|NCT00798707|144602730|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.41||||0.064|TWO_SIDED|95.0|-0.02|0.84|||ANCOVA|||Analysis was conducted using ANCOVA on the change from baseline with treatment as a factor and corresponding baseline value as a covariate for social life component score.||0.84|-0.02|0.064
72536481|NCT00798707|144602730|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.35||||0.104|TWO_SIDED|95.0|-0.07|0.78|||ANCOVA|||Analysis was conducted using ANCOVA on the change from baseline with treatment as a factor and corresponding baseline value as a covariate for social life component score.||0.78|-0.07|0.104
72536482|NCT00798707|144602730|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.29||||0.538|TWO_SIDED|95.0|-2.98|5.57|||ANCOVA|||Analysis was conducted using ANCOVA on the change from baseline with treatment as a factor and corresponding baseline value as a covariate for family life/home responsibilities component score.||5.57|-2.98|0.538
72536483|NCT00798707|144602730|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.43||||0.689|TWO_SIDED|95.0|-1.76|2.62|||ANCOVA|||Analysis was conducted using ANCOVA on the change from baseline with treatment as a factor and corresponding baseline value as a covariate for family life/home responsibilities component score||2.62|-1.76|0.689
72536484|NCT00798707|144602731|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.81||||0.066|TWO_SIDED|95.0|-1.67|0.05|||ANCOVA|||Analysis was conducted using ANCOVA on the change from baseline with treatment as a factor and corresponding baseline value as a covariate.||0.05|-1.67|0.066
72536485|NCT00798707|144602731|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.63||||0.15|TWO_SIDED|95.0|-1.48|0.23|||ANCOVA|||Analysis was conducted using ANCOVA on the change from baseline with treatment as a factor and corresponding baseline value as a covariate.||0.23|-1.48|0.150
72536486|NCT00798707|144602732|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.951||||0.8758|TWO_SIDED|95.0|0.51|1.78|||Regression, Logistic|||Analysis was conducted using a logistic regression model with treatment and gender as factors and baseline sexual dysfunction status as a covariate.||1.78|0.51|0.8758
72536487|NCT00798707|144602732|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.165||||0.6397|TWO_SIDED|95.0|0.61|2.21|||Regression, Logistic|||Analysis was conducted using a logistic regression model with treatment and gender as factors and baseline sexual dysfunction status as a covariate.||2.21|0.61|0.6397
72536488|NCT00798707|144602734|SUPERIORITY_OR_OTHER|||||||0.847|TWO_SIDED||||||t-test, 2 sided|||To address the multiplicity effect inherent in these comparisons, adjusted p-values based on the false discovery rate were used at Week 8 (or ET).||||0.847
72536489|NCT00798707|144602734|SUPERIORITY_OR_OTHER|||||||0.847|TWO_SIDED||||||t-test, 2 sided|||To address the multiplicity effect inherent in these comparisons, adjusted p-values based on the false discovery rate were used at Week 8 (or ET).||||0.847
72536490|NCT00798707|144602734|SUPERIORITY_OR_OTHER|||||||0.72|TWO_SIDED||||||t-test, 2 sided|||To address the multiplicity effect inherent in these comparisons, adjusted p-values based on the false discovery rate were used at Week 9 (or ET + 1 week).||||0.720
72536491|NCT00798707|144602734|SUPERIORITY_OR_OTHER|||||||0.72|TWO_SIDED||||||t-test, 2 sided|||To address the multiplicity effect inherent in these comparisons, adjusted p-values based on the false discovery rate were used at Week 9 (or ET + 1 week).||||0.720
72536492|NCT00798707|144602734|SUPERIORITY_OR_OTHER|||||||0.72|TWO_SIDED||||||t-test, 2 sided|||To address the multiplicity effect inherent in these comparisons, adjusted p-values based on the false discovery rate were used at Week 10 (or ET + 2 weeks).||||0.720
72536493|NCT00798707|144602734|SUPERIORITY_OR_OTHER|||||||0.72|TWO_SIDED||||||t-test, 2 sided|||To address the multiplicity effect inherent in these comparisons, adjusted p-values based on the false discovery rate were used at Week 10 (or ET + 2 weeks).||||0.720
72536494|NCT00929201|144602768|NON_INFERIORITY_OR_EQUIVALENCE|The FMI sitagliptin/metformin 50/500 mg FDC tablet and coadministration of corresponding doses of sitagliptin and metformin as individual tablets after consumption of a standard high-fat breakfast will be bioequivalent for metformin based on assessment of the AUC0-∞ for metformin \[i.e., the true metformin AUC0-∞GMR (sitagliptin/metformin 50/500 mg FDC tablet/co-administration of sitagliptin and metformin as individual tablets will be contained within (0.80, 1.25)\].|Least-Squares Mean Ratio|0.97||||||90.0|0.95|1.0||||||Least-Squares Mean Ratio calculated as Sitagliptin/Metformin 50/500 mg FDC tablet divided by Sitagliptin 50 mg and metformin 500 mg individual tablets||1.00|0.95|
72536495|NCT00929201|144602769|NON_INFERIORITY_OR_EQUIVALENCE|The FMI sitagliptin/metformin 50/500 mg FDC tablet and co-administration of corresponding doses of sitagliptin and metformin as individual tablets after consumption of a standard high-fat breakfast will be bioequivalent for metformin based on assessment of the Cmax for metformin \[i.e., the true metformin Cmax GMR (sitagliptin/metformin 50/500 mg FDC tablet/ co-administration of sitagliptin and metformin as individual tablets will be contained within (0.80, 1.25)\].|Least-Squares Mean Ratio|0.95||||||90.0|0.93|0.98||||||Least-Squares Mean Ratio calculated as Sitagliptin/Metformin 50/500 mg FDC tablet divided by Sitagliptin 50 mg and metformin 500 mg individual tablets||0.98|0.93|
72536496|NCT01299272|144602777|SUPERIORITY_OR_OTHER|||||||0.485|||||||Log Rank|||||||0.485
72408868|NCT00799617|144326315|SUPERIORITY||Mean Difference (Net)|-0.12||||0.89|TWO_SIDED|95.0|-1.89|1.65||The estimated difference and P-value were determined by a linear mixed-model with a random effect for participants using outcomes at month 6 and month 12.|Mixed Models Analysis||The difference is the mean difference in the change from baseline to 6 months to 12 months in participants allocated to testosterone vs placebo adjusted for balancing factors.|A positive estimated difference indicates greater increases, smaller decreases, or both for the testosterone group compared with the placebo group.||1.65|-1.89|.89
72536497|NCT00464308|144602806|NON_INFERIORITY_OR_EQUIVALENCE|A sample size of 450 subjects per arm will give a 90% power (with a one-sided 95% confidence interval and a minimal clinically important difference of 9%) to demonstrate non-inferiority of rabeprazole 20mg to esomeprazole 40mg with respect to the number of patients with complete resolution of heartburn with or without regurgitation at week 4|Proportion difference|-0.11|||<|0.05||95.0||||Adjustment for multiple comparisons was not made. The a priori threshold for statistical significance was p\<0.05. Tests were 2-sided except for the non-inferiority test which was 1-sided.|Non-inferiority||Assumed that the true resolution rates in the rab20 and eso40 groups would be 30% (0.3). Non inferiority was considered proven if the lower confidence interval of the one sided 95% CI of P(rab20)-P(e40) was above -9%|Primary endpoints were assessed using non-inferiority tests. See below.||||<0.05
72536498|NCT00464308|144602809|NON_INFERIORITY_OR_EQUIVALENCE|The sample size calculation was based upon the number of patients acheiveing complete resolution of HEARTBURN. A sample size of 450 subjects per arm will give a 90% power (with a one-sided 95% confidence interval and a minimal clinically important difference of 9%) to demonstrate non-inferiority of rabeprazole 20mg to esomeprazole 40mg with respect to the number of patients with complete resolution of heartburn with or without regurgitation at week 4|Proportion difference|-0.051|||<|0.05||95.0||||All statistical tests were interpreted at the 5% significance level (2-tailed).|non-inferiority||Non inferiority was considered proven if the lower confidence interval of the one sided 95% CI of P(rab20)-P(e40) was above -9%|Primary endpoints were assessed using non-inferiority tests. See below.||||<0.05
72536499|NCT00464308|144602810|NON_INFERIORITY_OR_EQUIVALENCE|The sample size calculation was based upon the number of patients acheiveing complete resolution of HEARTBURN. A sample size of 450 subjects per arm will give a 90% power (with a one-sided 95% confidence interval and a minimal clinically important difference of 9%) to demonstrate non-inferiority of rabeprazole 20mg to esomeprazole 40mg with respect to the number of patients with complete resolution of heartburn with or without regurgitation at week 4|Proportion difference|-0.053|||<|0.05||95.0||||Adjustment for multiple comparisons was not made. The a priori threshold for statistical significance was p\<0.05. Tests were 2-sided except for the non-inferiority test which was 1-sided.|non-inferiority||Non inferiority was considered proven if the lower confidence interval of the one sided 95% CI of P(rab20)-P(e40) was above -9%|Primary endpoints were assessed using non-inferiority tests. See below.||||<0.05
72573298|NCT03433755|144673222|SUPERIORITY||Treatment difference|-40.43|STANDARD_ERROR_OF_MEAN|4.13|<|0.0001|TWO_SIDED|95.0|-48.62|-32.24||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit as covariates.|Treatment difference = Evolocumab QM - Placebo QM|||-32.24|-48.62|< 0.0001
72573299|NCT03433755|144673223|SUPERIORITY||Treatment difference|-44.7|STANDARD_ERROR_OF_MEAN|5.07|<|0.0001|TWO_SIDED|95.0|-54.76|-34.65||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit as covariates.|Treatment difference = Evolocumab Q2W - Placebo Q2W|||-34.65|-54.76|< 0.0001
72408869|NCT00799617|144326316|SUPERIORITY||Mean Difference (Net)|-5.51||||0.14|TWO_SIDED|95.0|-12.91|1.88||The estimated difference and P-value were determined by a linear mixed-model with a random effect for participants using outcomes at month 6 and month 12.|Mixed Models Analysis||The difference is the mean difference in the change from baseline to 6 months to 12 months in participants allocated to testosterone vs placebo adjusted for balancing factors.|A positive estimated difference indicates greater increases, smaller decreases, or both for the testosterone group compared with the placebo group.||1.88|-12.91|.14
72408870|NCT00799617|144326317|SUPERIORITY||Mean Difference (Net)|0.83|||<|0.001|TWO_SIDED|95.0|0.48|1.39||The P-value for the significance of the treatment effect was determined by a linear mixed model for continuous outcomes with a random intercept for participant.|Mixed Models Analysis||Intent-to-treat analysis by a linear mixed effects model adjusted for balancing factors.|||1.39|0.48|<.001
72536500|NCT00464308|144602811|NON_INFERIORITY_OR_EQUIVALENCE|The sample size calculation was based upon the number of patients acheiveing complete resolution of HEARTBURN. A sample size of 450 subjects per arm will give a 90% power (with a one-sided 95% confidence interval and a minimal clinically important difference of 9%) to demonstrate non-inferiority of rabeprazole 20mg to esomeprazole 40mg with respect to the number of patients with complete resolution of heartburn with or without regurgitation at week 4|Proportion difference|-0.061|||<|0.05||95.0||||Adjustment for multiple comparisons was not made. The a priori threshold for statistical significance was p\<0.05. Tests were 2-sided except for the non-inferiority test which was 1-sided.|non-inferiority||Non inferiority was considered proven if the lower confidence interval of the one sided 95% CI of P(rab20)-P(e40) was above -9%|Primary endpoints were assessed using non-inferiority tests. See below.||||<0.05
72536501|NCT03533608|144602841|OTHER|Descriptive|Mean Difference (Final Values)|19.51|||||TWO_SIDED|||||||||||||
72536502|NCT03533608|144602842|OTHER|Descriptive|Mean Difference (Final Values)|4.04|||||TWO_SIDED|||||||||||||
72536503|NCT01900392|144602879|OTHER||||||>|0.1|||||||Regression, Linear|||||||>0.1
72626684|NCT02164864|144782256|OTHER||Hazard Ratio (HR)|1.09||||0.8537|TWO_SIDED|95.0|0.42|2.83||Wald 2-sided p-value from (unstratified) Cox proportional hazards model|Regression, Cox|unstratified Cox proportional hazards model was used and elderly patients outside the USA were excluded from|Hazard Ratio (HR) and Wald confidence intervals are derived from a Cox proportional-hazard model|||2.83|0.42|0.8537
72626685|NCT02164864|144782257|OTHER||Hazard Ratio (HR)|0.94||||0.9388|TWO_SIDED|95.0|0.19|4.66||Wald 2-sided p-value from (stratified) Cox proportional hazards model|Regression, Cox|The Cox proportional hazard model is stratified by age, non-elderly vs elderly \[\<70 or \>=70 in Japan and \<80 or \>=80 years old elsewhere\].|Hazard Ratio (HR) and Wald confidence intervals are derived from a Cox proportional-hazard model|||4.66|0.19|0.9388
72408871|NCT01848990|144326318|NON_INFERIORITY_OR_EQUIVALENCE|If the upper bound of the 95% CI for the treatment difference ≤0.40, it is concluded that Hylenex recombinant preadministration is noninferior to standard CSII.|least squares mean treatment difference|0.05||||0.4516|TWO_SIDED|95.0|-0.08|0.18|||ANOVA|Analysis of variance (ANOVA) with treatment (Hylenex, standard rapid-acting insulin CSII) as a fixed effect|Hylenex minus Standard CSII|Sample size calculated based on approximately 400 participants (Pt) being enrolled. No more than 10% dropout rate at 6 months allowed at least 270 Hylenex and 90 standard CSII Pt to reach primary metabolic endpoint evaluation. Assuming HbA1c standard deviation of 0.7% and population difference of 0% between treatments, Pt reaching primary efficacy endpoint would provide \>90% power to demonstrate HbA1c noninferiority at margin of 0.4% using confidence bound from 2-tailed 95% confidence interval.||0.18|-0.08|0.4516
72536504|NCT00826176|144602891|SUPERIORITY_OR_OTHER||upper limit of tolerance interval (min.)|6.4||||||95.0|||||||The tolerance interval (TI) refers to a fixed proportion (in this trial set to 95%) of the population with a stated confidence (in this trial, 95%). Efficacy was to be claimed in case the upper limit of TI was below the prespecified margin of 10 min.|||||
72536505|NCT00826176|144602891|SUPERIORITY_OR_OTHER||upper limit of tolerance interval (min.)|3.2||||||95.0|||||||The tolerance interval (TI) refers to a fixed proportion (in this trial set to 95%) of the population with a stated confidence (in this trial, 95%). Efficacy was to be claimed in case the upper limit of TI was below the prespecified margin of 10 min.|||||
72536506|NCT00826176|144602891|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence between the two subject populations was to be claimed in the event that the two-sided 95% confidence interval was entirely within the interval ranging from -60 to +60 seconds.|median difference (seconds)|49.0||||||95.0|30.0|72.0|||||The estimated median difference (Chinese minus Caucasian) in time to recovery of the T4/T1 ratio to 0.9.|||72|30|
72536507|NCT01687400|144602894|OTHER|||||||0.035|||||||Fisher Exact|||Statistical analysis #1 is for the genetic mutation TP53.||||0.035
72536508|NCT01687400|144602894|OTHER|||||||0.72|||||||Fisher Exact|||Statistical analysis #2 is for ASXL1 genetic mutation||||0.72
72536509|NCT01687400|144602894|OTHER|||||||0.28|||||||Fisher Exact|||Statistical analysis #3 is for SRSF2 genetic mutation||||0.28
72536510|NCT01687400|144602894|OTHER|||||||0.14|||||||Fisher Exact|||Statistical analysis #4 is for IDH2 genetic mutation||||0.14
72536511|NCT01687400|144602894|OTHER|||||||0.3|||||||Fisher Exact|||Statistical analysis #5 is for DNMT3A genetic mutation||||0.3
72536512|NCT01687400|144602894|OTHER|||||||0.183|||||||Fisher Exact|||Statistical analysis #6 is for SF3B1 genetic mutation||||0.183
72536513|NCT01687400|144602894|OTHER|||||||0.42|||||||Fisher Exact|||Statistical analysis #7 is for RUNX1 genetic mutation||||0.42
72536514|NCT01687400|144602894|OTHER|||||||0.36|||||||Fisher Exact|||Statistical analysis #8 is for TET2 genetic mutation||||0.36
72536515|NCT01687400|144602894|OTHER|||||||0.1|||||||Fisher Exact|||Statistical analysis #9 is for IDH1 genetic mutation||||0.1
72536516|NCT01687400|144602894|OTHER|||||||1|||||||Fisher Exact|||Statistical analysis #10 is for NPM1 genetic mutation||||1
72536517|NCT01687400|144602894|OTHER|||||||0.17|||||||Fisher Exact|||Statistical analysis #11 is for NRAS genetic mutation||||0.17
72536518|NCT01687400|144602894|OTHER|||||||1|||||||Fisher Exact|||-Statistical analysis #12 is for U2AF1 genetic mutation||||1
72536519|NCT01687400|144602894|OTHER|||||||0.6|||||||Fisher Exact|||Statistical analysis #13 is for MY05B genetic mutation||||0.6
72536520|NCT01687400|144602894|OTHER|||||||1|||||||Fisher Exact|||Statistical analysis #14 is for WT1 genetic mutation||||1
72536521|NCT01687400|144602895|SUPERIORITY||Overall Response Rate-for current study|0.744|||<|0.0001|TWO_SIDED|95.0|0.652|0.836|||Chi-squared|1-sample Chi-square test to compare the overall response rate (ORR) to historical control (with ORR=0.25)||-The historical control of a 5-day regimen (Cashen et al 2010 JCO = NCT00358644) showed 25% (14 out of 55 participants) in overall response rate||0.836|0.652|<0.0001
72536522|NCT01687400|144602895|SUPERIORITY||Complete response rate-for current study|0.64|||<|0.0001|TWO_SIDED|95.0|0.538|0.741|||Chi-squared|1-sample Chi-square test to compare the complete response rate to historical control (with CR=0.24)||-The historical control of a 5-day regimen (Cashen et al 2010 JCO = NCT00358644) showed 24% (13 out of 55 participants) in complete response rate.||0.741|0.538|<0.0001
72536523|NCT03731325|144602901|SUPERIORITY||Mean Difference (Net)|2.2|||<|0.01|TWO_SIDED||||||ANOVA||This mean difference represents the main effect of time from baseline to 15 weeks, regardless of group|Change in parent BMI from baseline at 8,11 to 15 weeks||||<0.01
72536524|NCT03731325|144602902|SUPERIORITY||Mean Difference (Net)|-10.5||||0.003|TWO_SIDED|||||main effect of time|ANOVA||This is the main effect of weight change at week 15, e.g. average weight change from baseline to week 15 in the entire sample of parents|repeated measures analysis of variance for time (0,8,11,15 weeks) for weight change (lbs)||||0.003
72536525|NCT03731325|144602903|SUPERIORITY||Mean Difference (Final Values)|-2.6||||0.06|TWO_SIDED||||||ANOVA||average difference in BMI percentile for entire sample|Repeated measures ANOVA for child BMI percentile at 0, 8, 11 and 15 weeks||||0.06
72536526|NCT03731325|144602904|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.07|TWO_SIDED||||||ANOVA||average change in delay discounting measure area under the curve for all participants (parents and children) in both groups from baseline to week 15|repeated measures ANOVA, reporting repeated measures effect only||||0.07
72536527|NCT03731325|144602905|SUPERIORITY||Mean Difference (Net)|-0.8||||0.64|TWO_SIDED||||||ANOVA||Difference between weight at baseline and week 15 in lbs for all children, regardless of group|||||0.64
72536528|NCT00297882|144602911|NON_INFERIORITY|Non-inferiority of AQ-AS compared to AL was assessed by constructing a one-sided, lower limit asymptotic 97.5% CI on the difference of polymerase chain reaction (PCR)-corrected cure rates of AQ-AS when compared to AL. Non-inferiority was declared if the lower limit of the CI was greater than -10% for AQ-AS.|||||>|0.05|TWO_SIDED|95.0|||||t-test, 2 sided|||Sample Size will be determined by N = {\[(Zα/2)/E\]\*2}pq where Where: n=sample size; Zα/2= Z value of a two-tailed test with 95% confidence level=1.96; p represents cure rate, q=1-p, which represents treatment failure rate of; E=precision of 5%||||>0.05
72536529|NCT00297882|144602912|NON_INFERIORITY|Non-inferiority of AQ-AS compared to AL was assessed by constructing a one-sided, lower limit asymptotic 97.5% CI on the difference of polymerase chain reaction (PCR)-corrected cure rates of AQ-AS when compared to AL. Non-inferiority was declared if the lower limit of the CI was greater than -10% for AQ-AS.|||||>|0.05|TWO_SIDED|95.0|||||t-test, 2 sided|||Sample Size will be determined by N = {\[(Zα/2)/E\]\*2}pq where Where: n=sample size; Zα/2= Z value of a two-tailed test with 95% confidence level=1.96; p represents cure rate, q=1-p, which represents treatment failure rate of; E=precision of 5%||||>0.05
72536530|NCT04242264|144602914|SUPERIORITY|A two-sided Chi-squared test with alpha=0.05 was used to test the null hypothesis that the vaccine efficacy is zero, which is equivalent to testing that the relative risk of shigellosis is one.|Vaccine efficacy|0.89|||<|0.001|TWO_SIDED|95.0|0.71|0.96|||Chi-squared||Vaccine efficacy was calculated as 1 - relative risk of shigellosis, where relative risk = probability of shigellosis in WRSs2 group / probability of shigellosis in placebo group. A Wilson (Score) CI was calculated for the vaccine efficacy estimate.|The null hypothesis is that the absolute vaccine efficacy (VE) of preventing shigellosis is zero. The alternative hypothesis is that the absolute VE is greater than zero.||0.96|0.71|<0.001
72626686|NCT02164864|144782257|OTHER||Hazard Ratio (HR)|0.3||||0.303|TWO_SIDED|95.0|0.03|2.93||Wald 2-sided p-value from (unstratified) Cox proportional hazards model|Regression, Cox|unstratified Cox proportional hazards model was used and elderly patients outside the USA were excluded from|Hazard Ratio (HR) and Wald confidence intervals are derived from a Cox proportional-hazard model|||2.93|0.03|0.3030
72408872|NCT01848990|144326319|NON_INFERIORITY_OR_EQUIVALENCE|If the upper bound of the 95% CI for the treatment difference ≤0.40, it is concluded that Hylenex recombinant preadministration is noninferior to standard CSII.|least squares mean treatment difference|0.14||||0.0711|TWO_SIDED|95.0|-0.01|0.28|||ANOVA|ANOVA with treatment (Hylenex, standard rapid-acting insulin CSII) as a fixed effect|Hylenex minus Standard CSII|Sample size calculated based on approximately 400 Pt being enrolled. No more than 10% dropout rate at 6 months allowed at least 270 Hylenex and 90 standard CSII Pt to reach primary metabolic endpoint evaluation. Assuming HbA1c standard deviation of 0.7% and population difference of 0% between treatments, Pt reaching primary efficacy endpoint would provide \>90% power to demonstrate HbA1c noninferiority at margin of 0.4% using confidence bound from 2-tailed 95% confidence interval.||0.28|-0.01|0.0711
72536531|NCT04242264|144602915|OTHER|Vaccine efficacy was calculated as 1 - relative risk of shigellosis, where relative risk = probability of shigellosis in WRSs2 group / probability of shigellosis in placebo group. A Wilson (Score) CI was calculated for the vaccine efficacy estimate, but no formal hypothesis test was performed.|Vaccine efficacy|0.77|||||TWO_SIDED|95.0|0.44|0.92||||||||0.92|0.44|
72536532|NCT04242264|144602915|OTHER|Vaccine efficacy was calculated as 1 - relative risk of shigellosis, where relative risk = probability of shigellosis in WRSs2 group / probability of shigellosis in placebo group. A Wilson (Score) CI was calculated for the vaccine efficacy estimate, but no formal hypothesis test was performed.|Vaccine efficacy|1.0|||||TWO_SIDED|95.0|0.78|1.0||||||||1.00|0.78|
72536533|NCT04242264|144602915|OTHER|Vaccine efficacy was calculated as 1 - relative risk of shigellosis, where relative risk = probability of shigellosis in WRSs2 group / probability of shigellosis in placebo group. A Wilson (Score) CI was calculated for the vaccine efficacy estimate, but no formal hypothesis test was performed.|Vaccine efficacy|1.0|||||TWO_SIDED|95.0|0.71|1.0||||||||1.00|0.71|
72536534|NCT00848965|144602951|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.38|STANDARD_ERROR_OF_MEAN|0.35|||TWO_SIDED|95.0|-2.08|-0.68|||||Treatment difference (FP minus placebo) is presented as the difference in the adjusted means for treatment versus placebo.|||-0.68|-2.08|
72536535|NCT00848965|144602951|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.55|STANDARD_ERROR_OF_MEAN|0.309|||TWO_SIDED|95.0|-2.16|-0.93|||||Treatment difference (FP minus placebo) is presented as the difference in the adjusted means for treatment versus placebo.|||-0.93|-2.16|
72536536|NCT00848965|144602951|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.72|STANDARD_ERROR_OF_MEAN|0.305|||TWO_SIDED|95.0|-2.33|-1.11|||||Treatment difference (FP minus placebo) is presented as the difference in the adjusted means for treatment versus placebo.|||-1.11|-2.33|
72536537|NCT00848965|144602951|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.9|STANDARD_ERROR_OF_MEAN|0.351|||TWO_SIDED|95.0|-2.6|-1.19|||||Treatment difference is presented as the difference in the adjusted means for treatment versus placebo.|||-1.19|-2.60|
72536538|NCT02329834|144602969|EQUIVALENCE|90% Confidence Interval 80\<ratio of AUC\<125. The FDA guided Bioequivalence limit of 80 to 125% for the ratio of the product averages has been adopted for use of an average BE criterion.|% diff Geometric Least Squared Mean|99.5|||||TWO_SIDED|90.0|94.77|104.75||||||||104.75|94.77|
72536539|NCT02329834|144602970|OTHER||% Diff Geometric Least Squared Mean|99.65|||||TWO_SIDED|90.0|94.79|104.75||||||||104.75|94.79|
72536540|NCT01976104|144602987|SUPERIORITY||Difference of proportion versus placebo|33.7|||=|0.0006|TWO_SIDED|95.0|15.8|51.6|||Cochran-Mantel-Haenszel|Stratified by the risk of bleeding associated with the scheduled procedure within each Baseline platelet count cohort.|Difference of proportion vs placebo = proportion of Responders for avatrombopag - proportion of Responders for placebo; 95% CI is calculated based on normal approximation.|The null hypothesis was that the proportion of participants not requiring a platelet transfusion or any rescue procedure for bleeding after randomization and up to 7 days following a scheduled procedure was the same between the 60 mg avatrombopag and matched placebo treatment groups.||51.6|15.8|=0.0006
72536541|NCT01976104|144602987|SUPERIORITY||Difference of proportion versus placebo|54.6|||<|0.0001|TWO_SIDED|95.0|36.5|72.7|||Cochran-Mantel-Haenszel|Stratified by the risk of bleeding associated with the scheduled procedure within each Baseline platelet count cohort|Difference of proportion vs placebo = proportion of Responders for avatrombopag - proportion of Responders for placebo; 95% CI is calculated based on normal approximation.|The null hypothesis was that the proportion of participants not requiring a platelet transfusion or any rescue procedure for bleeding after randomization and up to 7 days following a scheduled procedure was the same between the 60 mg avatrombopag and matched placebo treatment groups.||72.7|36.5|<0.0001
72536542|NCT01976104|144602988|SUPERIORITY||Difference of proportion versus placebo|60.2|||<|0.0001|TWO_SIDED|95.0|46.8|73.5|||Cochran-Mantel-Haenszel|Stratified by the risk of bleeding associated with the scheduled procedure within each Baseline platelet count cohort.|Difference of proportion vs placebo = proportion of responders for avatrombopag - proportion of responders for placebo; 95% CI is calculated based on normal approximation.|The null hypothesis was that the proportion of participants not requiring a platelet transfusion or any rescue procedure for bleeding after randomization and up to 7 days following a scheduled procedure was the same between the avatrombopag and placebo treatment groups.||73.5|46.8|<0.0001
72536543|NCT01976104|144602988|SUPERIORITY||Difference of proportion versus placebo|53.7|||<|0.0001|TWO_SIDED|95.0|35.8|71.6|||Cochran-Mantel-Haenszel|Stratified by the risk of bleeding associated with the scheduled procedure within each Baseline platelet count cohort.|Difference of proportion vs placebo = proportion of responders for avatrombopag - proportion of responders for placebo; 95% CI is calculated based on normal approximation.|The null hypothesis was that the proportion of participants not requiring a platelet transfusion or any rescue procedure for bleeding after randomization and up to 7 days following a scheduled procedure was the same between the avatrombopag and placebo treatment groups||71.6|35.8|<0.0001
72536544|NCT01976104|144602989|SUPERIORITY||Difference in change of platelet count|25.4|||<|0.0001|TWO_SIDED|95.0|19.5|32.0|||Wilcoxon Rank Sum Test|P-value was based on Wilcoxon Rank Sum Test for each avatrombopag treatment group versus placebo within each Baseline platelet count cohort.|Difference in change from Baseline of platelet count for avatrombopag versus placebo within each Baseline platelet count cohort was based on Hodges-Lehmann estimation; 95% CI was the asymptotic (Moses) CI|||32.0|19.5|<0.0001
72536545|NCT01976104|144602989|SUPERIORITY||Difference in change of platelet count|36.3|||<|0.0001|TWO_SIDED|95.0|25.5|45.5|||Wilcoxon Rank Sum Test|P-value was based on Wilcoxon Rank Sum Test for each avatrombopag treatment group versus placebo within each Baseline platelet count cohort.|Difference in change from baseline of platelet count for avatrombopag vs. placebo within each baseline platelet count cohort is based on Hodges-Lehmann estimation; 95% confidence interval is the asymptotic (Moses) CI.|||45.5|25.5|<0.0001
72536546|NCT01353209|144602997|SUPERIORITY|||||||0.4|||||||Mixed Models Analysis|Linear Mixed-Effects Model Adjusted for Sirolimus Use||||||0.4
72536547|NCT01353209|144602998|SUPERIORITY|||||||0.7|||||||Mixed Models Analysis|Linear Mixed-Effects Model Adjusted for Sirolimus Use||||||0.7
72536548|NCT01353209|144602999|SUPERIORITY|||||||0.8|||||||Regression, Linear|Linear Mixed-Effects Model Adjusted for Sirolimus Use||||||0.8
72573300|NCT03433755|144673223|SUPERIORITY||Treatment difference|-38.26|STANDARD_ERROR_OF_MEAN|5.88|<|0.0001|TWO_SIDED|95.0|-49.94|-26.59||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit as covariates.|Treatment difference = Evolocumab QM - Placebo QM|||-26.59|-49.94|< 0.0001
72536549|NCT01353209|144602999|SUPERIORITY|||||||0.8|||||||Regression, Linear|||||||.8
72536550|NCT01353209|144603000|SUPERIORITY|||||||0.015|||||||Mixed Models Analysis|Linear Mixed-Effects Model Adjusted for Sirolimus Use. P value was obtained for testing zero slope for log(VEGF-D).||||||0.015
72536551|NCT01335620|144603004|SUPERIORITY|||||||0.018|||||||Regression, Logistic|||Compare baseline to 24 weeks||||0.018
72536552|NCT02951182|144603006|SUPERIORITY||Least Squares (LS) Mean Difference|8.6||||0.0016|TWO_SIDED|95.0|3.5|13.8|||Mixed-effects Model for Repeated Measure|||||13.8|3.5|0.0016
72408873|NCT01848990|144326320|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|rate ratio|0.69||||0.0105|TWO_SIDED|||||SMBG \<56 mg/dL|negative binomial model||Hylenex/Standard CSII|||||0.0105
72536553|NCT02951182|144603006|SUPERIORITY||Least Squares (LS) Mean Difference|10.6||||0.0001|TWO_SIDED|95.0|5.5|15.8|||Mixed-effects Model for Repeated Measure|||||15.8|5.5|0.0001
72536554|NCT02951182|144603006|SUPERIORITY||Least Squares (LS) Mean Difference|12.0||||0.0001|TWO_SIDED|95.0|6.7|17.4|||Mixed-effects Model for Repeated Measure|||||17.4|6.7|0.0001
72536555|NCT02951182|144603007|SUPERIORITY||Least Squares (LS) Mean Difference|-22.3|||||TWO_SIDED|95.0|-32.1|-12.4||||||||-12.4|-32.1|
72536556|NCT02951182|144603007|SUPERIORITY||Least Squares (LS) Mean Difference|-34.7|||||TWO_SIDED|95.0|-44.7|-24.8||||||||-24.8|-44.7|
72536557|NCT02951182|144603007|SUPERIORITY||Least Squares (LS) Mean Difference|-33.4|||||TWO_SIDED|95.0|-48.5|-18.3||||||||-18.3|-48.5|
72573301|NCT03433755|144673224|SUPERIORITY||Treatment difference|-15.09|STANDARD_ERROR_OF_MEAN|4.71||0.008|TWO_SIDED|95.0|-24.44|-5.75||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit as covariates.|Treatment difference = Evolocumab Q2W - Placebo Q2W|||-5.75|-24.44|0.008
72408874|NCT01848990|144326320|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|rate ratio|0.79||||0.013|TWO_SIDED|||||SMBG \<=70 mg/dL|negative binomial model||Hylenex/Standard CSII|||||0.0130
72573302|NCT03433755|144673224|SUPERIORITY||Treatment difference|-19.67|STANDARD_ERROR_OF_MEAN|4.35|<|0.0001|TWO_SIDED|95.0|-28.3|-11.05||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit as covariates.|Treatment difference = Evolocumab QM - Placebo QM|||-11.05|-28.30|< 0.0001
72408875|NCT01848990|144326320|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|rate ratio|0.78||||0.0511|TWO_SIDED|||||Nocturnal HEs|negative binomial model||Hylenex/Standard CSII|||||0.0511
72408876|NCT01848990|144326320|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|rate ratio|0.34||||0.1176|TWO_SIDED|||||Severe HEs|negative binomial model||Hylenex/Standard CSII|||||0.1176
72408877|NCT01848990|144326321|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|rate ratio|0.81||||0.0456|TWO_SIDED|||||SMBG \<56 mg/dL|negative binomial model||Hylenex/Standard CSII|||||0.0456
72536558|NCT02951182|144603008|SUPERIORITY||Least Squares (LS) Mean Difference|14.8|||||TWO_SIDED|95.0|5.3|24.2||||||||24.2|5.3|
72536559|NCT02951182|144603008|SUPERIORITY||Least Squares (LS) Mean Difference|19.1|||||TWO_SIDED|95.0|9.7|28.6||||||||28.6|9.7|
72536560|NCT02951182|144603008|SUPERIORITY||Least Squares (LS) Mean Difference|20.0|||||TWO_SIDED|95.0|10.8|29.1||||||||29.1|10.8|
72536561|NCT02951182|144603009|SUPERIORITY||Least Squares (LS) Mean Difference|16.1|||||TWO_SIDED|95.0|5.4|26.8||||||||26.8|5.4|
72536562|NCT02951182|144603009|SUPERIORITY||Least Squares (LS) Mean Difference|18.5|||||TWO_SIDED|95.0|7.9|29.1||||||||29.1|7.9|
72573303|NCT03433755|144673225|SUPERIORITY||Treatment difference|-17.56|STANDARD_ERROR_OF_MEAN|5.98||0.008|TWO_SIDED|95.0|-29.42|-5.69||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit as covariates.|Treatment difference = Evolocumab Q2W - Placebo Q2W|||-5.69|-29.42|0.008
72408878|NCT01848990|144326321|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|rate ratio|0.92||||0.2322|TWO_SIDED|||||SMBG \<=70 mg/dL|negative binomial model||Hylenex/Standard CSII|||||0.2322
72408879|NCT01848990|144326321|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|rate ratio|0.87||||0.1365|TWO_SIDED|||||Nocturnal HEs|negative binomial model||Hylenex/Standard CSII|||||0.1365
72408880|NCT01848990|144326321|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|rate ratio|1.07||||0.8909|TWO_SIDED|||||Severe HEs|negative binomial model||Hylenex/Standard CSII|||||0.8909
72408881|NCT01848990|144326322|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|rate ratio|0.98||||0.7292|TWO_SIDED|||||SMBG \>240 mg/dL|negative binomial model||Hylenex/Standard CSII|||||0.7292
72408882|NCT01848990|144326322|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|rate ratio|0.95||||0.5895|TWO_SIDED|||||SMBG \>300 mg/dL|negative binomial model||Hylenex/Standard CSII|||||0.5895
72408883|NCT01848990|144326323|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|rate ratio|1.04||||0.5414|TWO_SIDED|||||SMBG \>240 mg/dL|negative binomial model||Hylenex/Standard CSII|||||0.5414
72408884|NCT01848990|144326323|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|rate ratio|1.03||||0.711|TWO_SIDED|||||SMBG \>300 mg/dL|negative binomial model||Hylenex/Standard CSII|||||0.7110
72408885|NCT01848990|144326324|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|-3.4||||0.5394|TWO_SIDED|95.0|-14.2|7.5||Breakfast|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII|||7.5|-14.2|0.5394
72408886|NCT01848990|144326324|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|4.3||||0.4151|TWO_SIDED|95.0|-6.1|14.8||Lunch|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII|||14.8|-6.1|0.4151
72408887|NCT01848990|144326324|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|0.0||||0.993|TWO_SIDED|95.0|-9.5|9.6||Dinner|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII|||9.6|-9.5|0.9930
72408888|NCT01848990|144326324|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|0.2||||0.941|TWO_SIDED|95.0|-6.4|6.9||Overall|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII|||6.9|-6.4|0.9410
72408889|NCT01848990|144326325|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|-4.8||||0.3239|TWO_SIDED|95.0|-14.3|4.7||Breakfast|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII|||4.7|-14.3|0.3239
72408890|NCT01848990|144326325|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|1.4||||0.754|TWO_SIDED|95.0|-7.4|10.2||Lunch|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII|||10.2|-7.4|0.7540
72536563|NCT02951182|144603009|SUPERIORITY||Least Squares (LS) Mean Difference|20.2|||||TWO_SIDED|95.0|11.9|28.4||||||||28.4|11.9|
72536564|NCT03237325|144603110|SUPERIORITY|||||||0.1798|||||||Log Rank|||||||0.1798
72536565|NCT00561600|144603112|NON_INFERIORITY_OR_EQUIVALENCE|non inferiority of proportion successful with 8% non inferiority margin at 24 months|percentage difference|0.139||||0.872|ONE_SIDED|95.0||0.225|||Chi-squared||The upper confidence limit was a priori determined to be a secondary endpoint|A non-inferiority test of the proportion successful for each treatment group will be the primary test of efficacy in this investigation. The null hypothesis is Ho: Xc-Xt ≥ 0.08 and the alternative hypothesis is HA:Xc-Xt \< 0.08 Sample size of 126 per group was needed assuming 93% success rates, this was increased to 150 per group to account for attrition.||.225||0.872
72536566|NCT00561600|144603113|SUPERIORITY_OR_OTHER|||||||0.167||95.0|||||t-test, 2 sided|Satterthwaite||||||0.167
72536567|NCT00561600|144603116|SUPERIORITY_OR_OTHER|||||||0.457|||||||Wilcoxon (Mann-Whitney)|||||||0.457
72536568|NCT00561600|144603117|SUPERIORITY_OR_OTHER|||||||0.762|||||||Wilcoxon (Mann-Whitney)|||||||0.762
72536569|NCT00561600|144603118|SUPERIORITY_OR_OTHER|||||||0.869|||||||Wilcoxon (Mann-Whitney)|||||||0.869
72536570|NCT00561600|144603119|SUPERIORITY_OR_OTHER|||||||0.799|||||||Wilcoxon (Mann-Whitney)|||||||0.799
72536571|NCT00561600|144603120|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||HO: Pinnacle=ASR-XL. The alternative hypothesis is HA: Pinnacle≠ASR-XL. Serum cobalt ions were expected to be lower in the ASR-XL group||||<0.001
72536572|NCT00561600|144603121|SUPERIORITY_OR_OTHER|||||||0.032|||||||Wilcoxon (Mann-Whitney)|||HO: Pinnacle=ASR-XL. The alternative hypothesis is HA: Pinnacle≠ASR-XL. Serum chromium ions were expected to be lower in the ASR-XL group||||0.032
72408891|NCT01848990|144326325|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|-1.1||||0.7904|TWO_SIDED|95.0|-9.5|7.2||Dinner|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII|||7.2|-9.5|0.7904
72408892|NCT01848990|144326325|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|-2.6||||0.4016|TWO_SIDED|95.0|-8.5|3.4||Overall|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII|||3.4|-8.5|0.4016
72408893|NCT01848990|144326326|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|-1.4||||0.526|TWO_SIDED|95.0|-5.6|2.9|||ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII|||2.9|-5.6|0.5260
72408894|NCT01848990|144326327|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|0.5||||0.8049|TWO_SIDED|95.0|-3.7|4.7|||ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII|||4.7|-3.7|0.8049
72408895|NCT01848990|144326328|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%||||||0.8955||||||HbA1c \<7.0%|Chi-squared|||||||0.8955
72408896|NCT01848990|144326328|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%||||||0.8926||||||HbA1c ≤6.5%|Chi-squared|||||||0.8926
72536573|NCT00561600|144603122|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||HO: Pinnacle=ASR-XL. The alternative hypothesis is HA: Pinnacle≠ASR-XL. Erythrocyte cobalt ions were expected to be lower in the ASR-XL group||||<0.001
72536574|NCT00561600|144603123|SUPERIORITY_OR_OTHER|||||||0.882|||||||Wilcoxon (Mann-Whitney)|||HO: Pinnacle=ASR-XL. The alternative hypothesis is HA: Pinnacle≠ASR-XL. Erythrocyte chromium ions were expected to be lower in the ASR-XL group||||0.882
72408897|NCT01848990|144326329|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|0.13||||0.7735|TWO_SIDED|95.0|-0.76|1.03|||ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII|||1.03|-0.76|0.7735
72408898|NCT01848990|144326330|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|-1.1||||0.4948|TWO_SIDED|95.0|-4.1|2.0||Daily bolus dose|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII|||2.0|-4.1|0.4948
72408899|NCT01848990|144326330|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|2.3||||0.1099|TWO_SIDED|95.0|-0.5|5.2||Daily basal dose|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII|||5.2|-0.5|0.1099
72408900|NCT01848990|144326330|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|1.4||||0.583|TWO_SIDED|95.0|-3.7|6.6||Daily total dose|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII|||6.6|-3.7|0.5830
72408901|NCT01848990|144326331|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|0.1||||0.8778|TWO_SIDED|95.0|-1.0|1.1|||ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII|||1.1|-1.0|0.8778
72408902|NCT01848990|144326332|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|-2.1||||0.3233|TWO_SIDED|95.0|-6.3|2.1|||ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII|||2.1|-6.3|0.3233
72408903|NCT01848990|144326334|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|1.0||||0.7708|TWO_SIDED|95.0|-5.8|7.8||Average glucose|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII|||7.8|-5.8|0.7708
72408904|NCT01848990|144326334|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|1.8||||0.6058|TWO_SIDED|95.0|-5.0|8.6||Median glucose|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII|||8.6|-5.0|0.6058
72408905|NCT01848990|144326334|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|-0.7||||0.6571|TWO_SIDED|95.0|-4.0|2.5||Average daily standard deviation|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII|||2.5|-4.0|0.6571
72408906|NCT01848990|144326335|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|-2.2||||0.6252|TWO_SIDED|95.0|-11.3|6.9||Time per day \<56 mg/dL|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII|||6.9|-11.3|0.6252
72408907|NCT01848990|144326335|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|-5.5||||0.5929|TWO_SIDED|95.0|-25.9|14.9||Time per day ≤70 mg/dL|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII|||14.9|-25.9|0.5929
72408908|NCT01848990|144326335|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|6.9||||0.5207|TWO_SIDED|95.0|-14.4|28.3||Time per day \>70 mg/dL|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII|||28.3|-14.4|0.5207
72408909|NCT01848990|144326335|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|-23.3||||0.4754|TWO_SIDED|95.0|-87.8|41.2||Time per day \<140 mg/dL|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII|||41.2|-87.8|0.4754
72408910|NCT01848990|144326335|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|23.9||||0.4644|TWO_SIDED|95.0|-40.7|88.6||Time per day ≥140 mg/dL|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII|||88.6|-40.7|0.4644
72536575|NCT00561600|144603124|SUPERIORITY_OR_OTHER|||||||0.005|||||||Wilcoxon (Mann-Whitney)|||HO: Pinnacle=ASR-XL. The alternative hypothesis is HA: Pinnacle≠ASR-XL. Serum cobalt ions were expected to be lower in the ASR-XL group||||0.005
72408911|NCT01848990|144326335|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|2.8||||0.9232|TWO_SIDED|95.0|-54.2|59.8||Time per day outside of 71 to 180 mg/dL|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII|||59.8|-54.2|0.9232
72408912|NCT01848990|144326335|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|18.4||||0.5151|TWO_SIDED|95.0|-37.5|74.4||Time per day outside of 71 to 139 mg/dL|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII|||74.4|-37.5|0.5151
72536576|NCT00561600|144603125|SUPERIORITY_OR_OTHER|||||||0.237|||||||Wilcoxon (Mann-Whitney)|||HO: Pinnacle=ASR-XL. The alternative hypothesis is HA: Pinnacle≠ASR-XL. Serum chromium ions were expected to be lower in the ASR-XL group||||0.237
72536577|NCT00561600|144603126|SUPERIORITY_OR_OTHER|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||HO: Pinnacle=ASR-XL. The alternative hypothesis is HA: Pinnacle≠ASR-XL. Erythrocyte cobalt ions were expected to be lower in the ASR-XL group||||0.001
72536578|NCT00561600|144603127|SUPERIORITY_OR_OTHER|||||||0.121|||||||Wilcoxon (Mann-Whitney)|||HO: Pinnacle=ASR-XL. The alternative hypothesis is HA: Pinnacle≠ASR-XL. Erythrocyte chromium ions were expected to be lower in the ASR-XL group||||0.121
72536579|NCT00561600|144603128|SUPERIORITY_OR_OTHER|||||||0.012|||||||Wilcoxon (Mann-Whitney)|||HO: Pinnacle=ASR-XL. The alternative hypothesis is HA: Pinnacle≠ASR-XL. Serum Cobalt ions were expected to be lower in the ASR-XL group||||0.012
72536580|NCT00561600|144603129|SUPERIORITY_OR_OTHER|||||||0.103|||||||Wilcoxon (Mann-Whitney)|||HO: Pinnacle=ASR-XL. The alternative hypothesis is HA: Pinnacle≠ASR-XL. Serum chromium ions were expected to be lower in the ASR-XL group||||0.103
72536581|NCT00561600|144603130|SUPERIORITY_OR_OTHER|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||HO: Pinnacle=ASR-XL. The alternative hypothesis is HA: Pinnacle≠ASR-XL. Erythrocyte cobalt ions were expected to be lower in the ASR-XL group||||0.001
72536582|NCT00561600|144603131|SUPERIORITY_OR_OTHER|||||||0.3|||||||Wilcoxon (Mann-Whitney)|||HO: Pinnacle=ASR-XL. The alternative hypothesis is HA: Pinnacle≠ASR-XL. Erythrocyte chromium ions were expected to be lower in the ASR-XL group||||0.300
72573304|NCT03433755|144673225|SUPERIORITY||Treatment difference|-12.35|STANDARD_ERROR_OF_MEAN|5.38|<|0.0001|TWO_SIDED|95.0|-23.04|-1.67||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit as covariates.|Treatment difference = Evolocumab QM - Placebo QM|||-1.67|-23.04|< 0.0001
72573305|NCT03433755|144673226|SUPERIORITY||Treatment difference|8.44|STANDARD_ERROR_OF_MEAN|2.56||0.008|TWO_SIDED|95.0|3.35|13.52||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit as covariates.|Treatment difference = Evolocumab Q2W - Placebo Q2W|||13.52|3.35|0.008
72573306|NCT03433755|144673226|SUPERIORITY||Treatment difference|6.8|STANDARD_ERROR_OF_MEAN|2.37||0.017|TWO_SIDED|95.0|2.1|11.5||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit as covariates.|Treatment difference = Evolocumab QM - Placebo QM|||11.50|2.10|0.017
72573307|NCT03433755|144673227|SUPERIORITY||Treatment difference|7.94|STANDARD_ERROR_OF_MEAN|2.91||0.008|TWO_SIDED|95.0|2.18|13.71||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit as covariates.|Treatment difference = Evolocumab Q2W - Placebo Q2W|||13.71|2.18|0.008
72573308|NCT03433755|144673227|SUPERIORITY||Treatment difference|6.17|STANDARD_ERROR_OF_MEAN|0.036||0.017|TWO_SIDED|95.0|0.42|11.92||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit as covariates.|Treatment difference = Evolocumab QM - Placebo QM|||11.92|0.42|0.017
72408913|NCT01848990|144326336|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|-33.5||||0.4216|TWO_SIDED|95.0|-115.9|48.9||Area per day \<56 mg/dL|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII|||48.9|-115.9|0.4216
72408914|NCT01848990|144326336|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|-84.7||||0.5697|TWO_SIDED|95.0|-379.2|209.8||Area per day ≤70 mg/dL|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII|||209.8|-379.2|0.5697
72408915|NCT01848990|144326336|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|342.9||||0.9241|TWO_SIDED|95.0|-6772.3|7458.2||Area per day ≥140 mg/dL|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII|||7458.2|-6772.3|0.9241
72408916|NCT01848990|144326336|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|2.8||||0.9232|TWO_SIDED|95.0|-54.2|59.8||Area per day outside of 71 to 180 mg/dL|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII|||59.8|-54.2|0.9232
72408917|NCT01848990|144326336|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|Mean Difference (Final Values)|258.2||||0.9423|TWO_SIDED|95.0|-6792.2|7308.7||Area per day outside of 71 to 139 mg/dL|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Least squares mean treatment difference (Hylenex minus Standard CSII)|||7308.7|-6792.2|0.9423
72536583|NCT00561600|144603132|SUPERIORITY_OR_OTHER|||||||0.079|||||||Wilcoxon (Mann-Whitney)|||HO: Pinnacle=ASR-XL. The alternative hypothesis is HA: Pinnacle≠ASR-XL. Serum cobalt ions were expected to be lower in the ASR-XL group||||0.079
72536584|NCT00561600|144603133|SUPERIORITY_OR_OTHER|||||||0.766|||||||Wilcoxon (Mann-Whitney)|||HO: Pinnacle=ASR-XL. The alternative hypothesis is HA: Pinnacle≠ASR-XL. Serum chromium ions were expected to be lower in the ASR-XL group||||0.766
72536585|NCT00561600|144603134|SUPERIORITY_OR_OTHER|||||||0.018|||||||Wilcoxon (Mann-Whitney)|||HO: Pinnacle=ASR-XL. The alternative hypothesis is HA: Pinnacle≠ASR-XL. Erythrocyte cobalt ions were expected to be lower in the ASR-XL group||||0.018
72536586|NCT00561600|144603135|SUPERIORITY_OR_OTHER|||||||0.689|||||||Wilcoxon (Mann-Whitney)|||HO: Pinnacle=ASR-XL. The alternative hypothesis is HA: Pinnacle≠ASR-XL. Erythrocyte chromium ions were expected to be lower in the ASR-XL group||||0.689
72369221|NCT00611026|144248556|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.1||0.0407|TWO_SIDED|95.0|-0.6|0.0|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.|"Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type:~standard error of the mean."|Treatment difference Tolterodine ER vs placebo at Week 12.||-0.0|-0.6|0.0407
72369222|NCT00611026|144248556|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.1||0.0016|TWO_SIDED|95.0|-0.6|-0.1|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.|"Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type:~standard error of the mean."|Treatment difference fesoterodine vs Tolterodine ER at Week 12.||-0.1|-0.6|0.0016
72536587|NCT00561600|144603136|SUPERIORITY_OR_OTHER|||||||0.048|||||||Wilcoxon (Mann-Whitney)|||HO: Pinnacle=ASR-XL. The alternative hypothesis is HA: Pinnacle≠ASR-XL. Serum cobalt ions were expected to be lower in the ASR-XL group||||0.048
72536588|NCT00561600|144603137|SUPERIORITY_OR_OTHER|||||||0.782|||||||Wilcoxon (Mann-Whitney)|||HO: Pinnacle=ASR-XL. The alternative hypothesis is HA: Pinnacle≠ASR-XL. Serum chromium ions were expected to be lower in the ASR-XL group||||0.782
72536589|NCT00561600|144603138|SUPERIORITY_OR_OTHER|||||||0.061|||||||Wilcoxon (Mann-Whitney)|||HO: Pinnacle=ASR-XL. The alternative hypothesis is HA: Pinnacle≠ASR-XL. Erythrocyte cobalt ions were expected to be lower in the ASR-XL group||||0.061
72536590|NCT00561600|144603139|SUPERIORITY_OR_OTHER|||||||0.957|||||||Wilcoxon (Mann-Whitney)|||HO: Pinnacle=ASR-XL. The alternative hypothesis is HA: Pinnacle≠ASR-XL. Erythrocyte chromium ions were expected to be lower in the ASR-XL group||||0.957
72536591|NCT02181673|144603152|SUPERIORITY_OR_OTHER||Percent Difference|53.4|||<|0.001|TWO_SIDED|95.0|45.8|60.9|||Cochran-Mantel-Haenszel|||||60.90|45.80|<0.001
72536592|NCT04764669|144603164|SUPERIORITY|Primary comparisons were: DLB without amyloid copathology versus DLB with amyloid copathology|Least squares mean difference|-20.022|||||TWO_SIDED|95.0|-77.635|37.591||||||||37.591|-77.635|
72536593|NCT04764669|144603164|SUPERIORITY|Primary comparisons were: PDD without amyloid copathology versus PDD with amyloid copathology.|Least squares mean difference|-175.65|||||TWO_SIDED|95.0|-287.407|-63.893||||||||-63.893|-287.407|
72369223|NCT00611026|144248557|SUPERIORITY_OR_OTHER|||||||0.0217|TWO_SIDED|||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with country and treatment as factors, and ranked baseline value as a covariate.||Treatment difference fesoterodine vs placebo at Week 1.||||0.0217
72536594|NCT04776135|144603172|OTHER|AUC0-t was log-transformed and analyzed by analysis of variance using administration groups, the administration route, study periods, and subjects as factors. Estimates of the mean values on the log scale, the mean difference between administration routes on the log scale, and 90% CIs for the difference were back transformed to present mean ratios and their 90% CIs for administration via NGT to oral administration.|Ratio (NGT/oral)|0.987|||||TWO_SIDED|90.0|0.936|1.041|||ANOVA|||For AUC0-t, MT-1186 orally Versus MT-1186 via NGT||1.041|0.936|
72536595|NCT04776135|144603172|OTHER|AUC0-inf was log-transformed and analyzed by analysis of variance using administration groups, the administration route, study periods, and subjects as factors. Estimates of the mean values on the log scale, the mean difference between administration routes on the log scale, and 90% CIs for the difference were back transformed to present mean ratios and their 90% CIs for administration via NGT to oral administration.|Ratio (NGT/oral)|0.981|||||TWO_SIDED|90.0|0.931|1.033|||ANOVA|||For AUC0-inf, MT-1186 orally Versus MT-1186 via NGT||1.033|0.931|
72536596|NCT04776135|144603173|OTHER|Cmax was log-transformed and analyzed by analysis of variance using administration groups, the administration route, study periods, and subjects as factors. Estimates of the mean values on the log scale, the mean difference between administration routes on the log scale, and 90% CIs for the difference were back transformed to present mean ratios and their 90% CIs for administration via NGT to oral administration.|Ratio (NGT/oral)|1.052|||||TWO_SIDED|90.0|0.903|1.227|||ANOVA|||MT-1186 orally Versus MT-1186 via NGT||1.227|0.903|
72536597|NCT00379821|144603212|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.0413|STANDARD_ERROR_OF_MEAN|0.1746||0.8097|TWO_SIDED|95.0|0.7497|1.4463||The a priori threshold for statistical significance is 0.05/3.|Poisson regression|No adjustments|The denominator for the risk ratio is the CQ Monotherapy arm.|Number of clinical malaria episodes per PYAR was compared using Poisson regression assuming null hypothesis that the number of malaria episodes are the same in both groups.||1.4463|0.7497|0.8097
72536598|NCT00379821|144603212|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.1623|STANDARD_ERROR_OF_MEAN|0.1973||0.3767|TWO_SIDED|95.0|0.8333|1.6211||The a priori threshold for statistical significance is 0.05/3.|Poisson regression|No adjustments.|The denominator for the risk ratio is the CQ Monotherapy arm.|Number of clinical malaria episodes per PYAR was compared using Poisson regression assuming null hypothesis that the number of malaria episodes are the same in both groups.||1.6211|0.8333|0.3767
72573309|NCT03433755|144673228|SUPERIORITY||Treatment difference|-22.96|STANDARD_ERROR_OF_MEAN|4.44||0.0002|TWO_SIDED|95.0|-33.12|-12.81||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit as covariates.|Treatment difference = Evolocumab Q2W - Placebo Q2W|||-12.81|-33.12|0.0002
72573310|NCT03433755|144673228|SUPERIORITY||Treatment difference|-27.81|STANDARD_ERROR_OF_MEAN|4.44|<|0.0001|TWO_SIDED|95.0|-36.6|-19.02||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit as covariates.|Treatment difference = Evolocumab QM - Placebo QM|||-19.02|-36.60|< 0.0001
72573311|NCT03433755|144673229|SUPERIORITY||Treatment difference|-21.78|STANDARD_ERROR_OF_MEAN|6.32||0.0002|TWO_SIDED|95.0|-34.31|-9.25||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit as covariates.|Treatment difference = Evolocumab Q2W - Placebo Q2W|||-9.25|-34.31|0.0002
72408918|NCT01848990|144326337|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|-0.2||||0.5246|TWO_SIDED|95.0|-0.7|0.4||Leisure activities|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII|||0.4|-0.7|0.5246
72536599|NCT00379821|144603212|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.0707|STANDARD_ERROR_OF_MEAN|0.1795||0.6277|TWO_SIDED|95.0|0.7708|1.4872||The a priori threshold for statistical significance is 0.05/3.|Poisson regression|No adjustments.|The denominator for the risk ratio is the CQ Monotherapy arm.|Number of clinical malaria episodes per PYAR was compared using Poisson regression assuming null hypothesis that the number of malaria episodes are the same in both groups.||1.4872|0.7708|0.6277
72536600|NCT00379821|144603246|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.96|STANDARD_ERROR_OF_MEAN|0.17||0.79|TWO_SIDED|95.0|0.68|1.34||Not adjusted, 0.05|Regression, Cox|There are no adjustments.|The reference category is those who did not travel.|||1.34|0.68|0.79
72536601|NCT04502862|144603255|OTHER||Least square mean difference|-0.07|STANDARD_ERROR_OF_MEAN|0.107||0.512|TWO_SIDED|95.0|-0.28|0.14||A hierarchical testing procedure was used to control type I error and handle primary and first 2 secondary endpoints (reported sequentially) analyses at a 2-sided significance level of 0.05.|MMRM|||The MMRM model included study intervention, age, body mass index (BMI), region (Eastern Europe, rest of world \[ROW\]), inhaled corticosteroids \[ICS\] dose level at baseline (ICS dose level medium, ICS dose level high), visit (up to Week 12), study intervention-by-visit interaction, baseline asthma control questionnaire (ACQ-5), baseline sleep disturbance score and baseline-by-visit interaction as covariates.||0.14|-0.28|0.512
72536602|NCT04502862|144603256|OTHER||Least square mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.11||0.967|TWO_SIDED|95.0|-0.21|0.22||A hierarchical testing procedure was used to control type I error and handle primary and first 2 secondary endpoints (reported sequentially) analyses at a 2-sided significance level of 0.05.|MMRM|||The MMRM model included study intervention, age, BMI, region (Eastern Europe, ROW), ICS dose level at baseline (ICS dose level medium, ICS dose level high), visit (up to Week 12), study intervention-by-visit interaction, baseline ACQ-5, baseline number of nocturnal awakenings and baseline-by-visit interaction as covariates.||0.22|-0.21|0.967
72536603|NCT04502862|144603257|OTHER||Least square mean difference|-0.7|STANDARD_ERROR_OF_MEAN|0.865||0.422|TWO_SIDED|95.0|-2.4|1.01||A hierarchical testing procedure was used to control type I error and handle primary and first 2 secondary endpoints (reported sequentially) analyses at a 2-sided significance level of 0.05|MMRM|||The MMRM model included study intervention, age, BMI, region (Eastern Europe, ROW), ICS dose level at baseline (ICS dose level medium, ICS dose level high), visit (up to Week 12), study intervention-by-visit interaction, baseline ACQ-5, baseline PROMIS total score and baseline-by-visit interaction as covariates.||1.01|-2.40|0.422
72536604|NCT02087865|144603286|SUPERIORITY||Mean Difference (Final Values)|-8.25|STANDARD_ERROR_OF_MEAN|7.59||0.273|TWO_SIDED|95.0|-23.12|6.63|||ANCOVA|||We are reporting the difference in mean between the Donepezil HCL and Placebo groups.||6.63|-23.12|0.273
72536605|NCT02087865|144603287|SUPERIORITY||Mean Difference (Final Values)|-13.41|STANDARD_ERROR_OF_MEAN|3.92||0.001|TWO_SIDED|95.0|-21.09|-5.73|||ANCOVA|||We are reporting the difference in mean between the Donepezil HCL and Placebo groups.||-5.73|-21.09|0.001
72536606|NCT02087865|144603288|SUPERIORITY||Median Difference (Final Values)|-8.6|STANDARD_ERROR_OF_MEAN|5.48||0.115|TWO_SIDED|95.0|-19.33|2.14|||ANCOVA|||We are reporting the difference in mean between the Donepezil HCL and Placebo groups.||2.14|-19.33|0.115
72536607|NCT02087865|144603289|SUPERIORITY||Mean Difference (Final Values)|0.15|STANDARD_ERROR_OF_MEAN|2.09||0.941|TWO_SIDED|95.0|-3.94|4.25|||ANCOVA|||We are reporting the difference in mean between the Donepezil HCL and Placebo groups.||4.25|-3.94|0.941
72536608|NCT02087865|144603290|SUPERIORITY||Mean Difference (Final Values)|46.33|STANDARD_ERROR_OF_MEAN|15.4||0.003|TWO_SIDED|95.0|16.14|76.53|||ANCOVA|||We are reporting the difference in mean between the Donepezil HCL and Placebo groups.||76.53|16.14|0.003
72536609|NCT02087865|144603291|SUPERIORITY||Mean Difference (Final Values)|61.36|STANDARD_ERROR_OF_MEAN|13.32|<|0.001|TWO_SIDED|95.0|35.25|87.46|||ANCOVA|||We are reporting the difference in mean between the Donepezil HCL and Placebo groups.||87.46|35.25|<0.001
72536610|NCT02087865|144603292|SUPERIORITY||Mean Difference (Final Values)|-3.35|STANDARD_ERROR_OF_MEAN|1.18||0.005|TWO_SIDED|95.0|-5.65|-1.04|||ANCOVA|||We are reporting the difference in mean between the Donepezil HCL and Placebo groups.||-1.04|-5.65|0.005
72536611|NCT02087865|144603293|SUPERIORITY||Mean Difference (Final Values)|-4.3|STANDARD_ERROR_OF_MEAN|1.67||0.011|TWO_SIDED|95.0|-7.58|-1.02|||ANCOVA|||We are reporting the difference in mean between the Donepezil HCL and Placebo groups.||-1.02|-7.58|0.011
72536612|NCT00741026|144603294|SUPERIORITY_OR_OTHER|||||||0.0203|||||||Wilcoxon Signed-rank|||||||0.0203
72536613|NCT00741026|144603295|SUPERIORITY_OR_OTHER|||||||0.0105|||||||Wilcoxon Sign-rank|||||||0.0105
72536614|NCT00741026|144603296|SUPERIORITY_OR_OTHER|||||||0.0166|||||||Wilcoxon Sign-rank|||||||0.0166
72536615|NCT00741026|144603297|SUPERIORITY_OR_OTHER|||||||0.0184|||||||Wilcoxon Sign-rank|||||||0.0184
72536616|NCT00741026|144603298|SUPERIORITY_OR_OTHER|||||||0.017|||||||Wilcoxon Sign-rank|||||||0.0170
72536617|NCT01392469|144603319|SUPERIORITY||Ratio (Test/Reference)|1.17|||||TWO_SIDED|90.0|1.03|1.33||||||||1.33|1.03|
72536618|NCT01392469|144603319|SUPERIORITY||Ratio (Test/Reference)|1.4|||||TWO_SIDED|90.0|1.23|1.59||||||||1.59|1.23|
72536619|NCT01392469|144603320|SUPERIORITY||Ratio (Test/Reference)|1.36|||||TWO_SIDED|90.0|1.14|1.62||||||||1.62|1.14|
72536620|NCT01392469|144603320|SUPERIORITY||Ratio (Test/Reference)|1.7|||||TWO_SIDED|90.0|1.43|2.03||||||||2.03|1.43|
72536621|NCT01392469|144603321|SUPERIORITY||Ratio (Test/Reference)|1.0|||||TWO_SIDED|90.0|0.82|1.21||||||||1.21|0.82|
72536622|NCT01392469|144603321|SUPERIORITY||Ratio (Test/Reference)|1.07|||||TWO_SIDED|90.0|0.88|1.31||||||||1.31|0.88|
72536623|NCT01392469|144603322|SUPERIORITY||Ratio (Test/Reference)|1.28|||||TWO_SIDED|90.0|1.03|1.61||||||||1.61|1.03|
72536624|NCT01392469|144603322|SUPERIORITY||Ratio (Test/Reference)|1.56|||||TWO_SIDED|90.0|1.24|1.95||||||||1.95|1.24|
72536625|NCT02712359|144603357|NON_INFERIORITY|The lower limit of the 2-sided 95% confidence interval (CI) for the difference (Havrix 1 dose\_Year 8 Group minus Havrix 2 doses\_Year 8 Group) of percentage of subjects with anti-HAV antibody concentrations ≥ 15 mIU/mL was to be greater than or equal to the pre-defined clinical non-inferiority limit of -10%.|Difference in seropositivity rate|-23.33|||<|0.0001|TWO_SIDED|95.0|-28.78|-18.29|||Fisher Exact|||Difference in seropositivity rates for anti-HAV antibody: To demonstrate that 1-dose schedule of Havrix (Havrix 1 dose\_Year 8 Group) was non-inferior to the 2-dose schedule of Havrix (Havrix 2 doses\_Year 8 Group), in terms of seropositivity rates for anti-HAV antibody, measured by ELISA, approximately 8 years after the administration of the last vaccine dose.||-18.29|-28.78|<0.0001
72536626|NCT02712359|144603358|NON_INFERIORITY|The lower limit of the 2-sided 95% confidence interval (CI) for the difference (Havrix 1 dose\_Year 10 Group minus Havrix 2 doses\_Year 10 Group) of percentage of subjects with anti-HAV antibody concentrations ≥ 15 mIU/mL was to be greater than or equal to the pre-defined clinical non-inferiority limit of -10%.|Difference in seropositivity rate|-24.43|||<|0.0001|TWO_SIDED|95.0|-30.11|-19.03|||Fisher Exact|||Difference in seropositivity rates for anti-HAV antibody: To demonstrate that 1-dose schedule of Havrix (Havrix 1 dose\_Year 10 Group) was non-inferior to the 2-dose schedule of Havrix (Havrix 2 doses\_Year 10 Group), in terms of seropositivity rates for anti-HAV antibody, measured by ELISA, approximately 10 years after the administration of the last vaccine dose.||-19.03|-30.11|<0.0001
72408919|NCT01848990|144326337|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|-0.1||||0.638|TWO_SIDED|95.0|-0.8|0.5||Work life|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII|||0.5|-0.8|0.6380
72536627|NCT00684645|144603392|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.395|||<|0.0001|TWO_SIDED|95.0|0.257|0.609|||Cox proportional hazard|||Time to PFS was analyzed using survival analysis methodology. Model was fitted with sunitinib-induced hypertension included as a time-dependent covariate (presence versus absence of hypertension).||0.609|0.257|<0.0001
72536628|NCT00684645|144603393|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.361||||0.0221|TWO_SIDED|95.0|0.151|0.864|||Cox proportional hazard|||Time to OS was analyzed using survival analysis methodology. Model was fitted with sunitinib-induced hypertension included as a time-dependent covariate (presence versus absence of hypertension).||0.864|0.151|0.0221
72536629|NCT03126682|144603404|SUPERIORITY|||||||0.212||||||Threshold of \<0.05|t-test, 2 sided|||||||0.212
72536630|NCT02513095|144603415|SUPERIORITY||Odds Ratio (OR)|6.0||||0.396|TWO_SIDED|95.0|0.6|76.8|||Chi-squared, Corrected|||||76.8|0.6|0.396
72536631|NCT01441401|144603444|SUPERIORITY_OR_OTHER_LEGACY|||||||0.045|||||||Fisher Exact|||"The factor tested was baseline severity of epileptic seizure. The null hypothesis was that there was no association between the baseline severity of epileptic seizure (mild, moderate, and severe) and the number of participants who responded to the treatment with gabapentin."||||0.045
72536632|NCT01441401|144603444|SUPERIORITY_OR_OTHER_LEGACY|||||||0.017|||||||Cochran-Armitage (EXACT)|||"The factor tested was baseline severity of epileptic seizure. The null hypothesis was that there was no ordinal trend in the number of responders to the treatment with gabapentin across the baseline severity of epileptic seizure (mild, moderate, and severe)."||||0.017
72536633|NCT01441401|144603445|SUPERIORITY_OR_OTHER_LEGACY|||||||0.018|||||||Fisher Exact|||"The factor tested was baseline frequency of epileptic seizure. The null hypothesis was that there was no difference between the baseline frequency of epileptic seizure and the number of participants who responded to the treatment with gabapentin."||||0.018
72536634|NCT01441401|144603446|SUPERIORITY_OR_OTHER_LEGACY|||||||0.034|||||||Fisher Exact|||"The factor tested was number of concomitant antiepileptic drugs at baseline. The null hypothesis was that there was no association between the number of concomitant antiepileptic drugs at baseline and the number of participants who responded to the treatment with gabapentin."||||0.034
72536635|NCT01441401|144603446|SUPERIORITY_OR_OTHER_LEGACY|||||||0.005|||||||Cochran-Armitage (EXACT)|||"The factor tested was number of concomitant antiepileptic drugs at baseline. The null hypothesis was that there was no ordinal trend in the number of responders to the treatment with gabapentin across the increasing number of concomitant antiepileptic drugs at baseline."||||0.005
72536636|NCT01441401|144603447|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Fisher Exact|||"The factor tested was treatment period with gabapentin. The null hypothesis was that there was no association between the treatment period with gabapentin and the number of participants who responded to the treatment with gabapentin."||||<0.001
72536637|NCT03256526|144603453|SUPERIORITY||LS mean difference|11.45||||0.1654|TWO_SIDED|90.0|-2.19|25.09|||ANCOVA|||||25.09|-2.19|0.1654
72536638|NCT03256526|144603453|SUPERIORITY||LS mean difference|-18.73||||0.0395|TWO_SIDED|90.0|-33.55|-3.9|||ANCOVA|||||-3.90|-33.55|0.0395
72536639|NCT01607398|144603483|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-8.05||||0.5146|TWO_SIDED|95.0|-20.5|7.6|||Wilcoxon (Mann-Whitney)|The analysis was done using the Van Elteren extension to the Wilcoxon rank sum test.|From Van-Elteren extension to the Wilcoxon Rank Sum test, adjusted for smoking status strata and Hodges-Lehmann estimator of the 95% CI, not stratified and unadjusted for multiplicity.|||7.600|-20.500|0.5146
72536640|NCT04139642|144603517|SUPERIORITY||||||<|0.0001||||||A mixed-effects model with provider as a random effect and month as a fixed effect was used to test the main effect of arm.|Mixed Models Analysis|||The null hypothesis was that the rate of balance-related diagnosis as a percentage of total visits would be the same between the historical control period, the active control (weight-only), and the intervention (balance+weight), considering provider and month as co-variates.||||<0.0001
72536641|NCT04139642|144603518|SUPERIORITY||||||=|0.15||||||Mixed-effects model with provider as a random effect and month as a fixed effect. Statistical significance a priori threshold set at 0.05.|Mixed Models Analysis|||The null hypothesis was that the rate of balance-related referral as a percentage of total visits would be the same between the historical control period, the active control (weight-only), and the intervention (balance+weight), considering provider and month as co-variates.||||=0.15
72536642|NCT00539006|144603555|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.1|STANDARD_ERROR_OF_MEAN|0.22|<|0.001||95.0|-1.5|-0.6|||ANCOVA||Mean Difference = Mean Change in FFNS - Mean Change in Placebo|FFNS combined across treatment arms 1 \& 2 compared with Placebo FFNS combined across treatment arms 1 \& 2.||-0.6|-1.5|<0.001
72408920|NCT01848990|144326337|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|-0.2||||0.5719|TWO_SIDED|95.0|-0.7|0.4||Local or long distance travel|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII|||0.4|-0.7|0.5719
72408921|NCT01848990|144326337|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|-0.2||||0.4052|TWO_SIDED|95.0|-0.8|0.3||Vacations|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII|||0.3|-0.8|0.4052
72408922|NCT01848990|144326337|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|0.1||||0.724|TWO_SIDED|95.0|-0.4|0.6||Do physically|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII|||0.6|-0.4|0.7240
72408923|NCT01848990|144326337|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|0.1||||0.6876|TWO_SIDED|95.0|-0.4|0.6||Family life|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII|||0.6|-0.4|0.6876
72408924|NCT01848990|144326337|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|0.1||||0.6478|TWO_SIDED|95.0|-0.4|0.6||Friendships and social life|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII|||0.6|-0.4|0.6478
72536643|NCT00539006|144603555|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.6|STANDARD_ERROR_OF_MEAN|0.22||0.004||95.0|-1.1|-0.2|||ANCOVA||Mean Difference = Mean Change in FPNS - Mean Change in Placebo|FPNS combined across treatment arms 1 \& 2 compared with Placebo FPNS combined across treatment arms 1 \& 2.||-0.2|-1.1|0.004
72536644|NCT00539006|144603556|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel(CMH): stratified approximation to Prescotts test; variation of chi-square test for treatment sequence/subjects no preference.||Statistical analysis applies to FFNS and FPNS categories.||||<0.001
72536645|NCT01783860|144603561|SUPERIORITY_OR_OTHER|||||||0.03||95.0|||||t-test, 1 sided|||||||0.03
72536646|NCT01783860|144603562|SUPERIORITY_OR_OTHER|||||||0.01||95.0|||||t-test, 1 sided|||||||0.01
72536647|NCT01783860|144603563|SUPERIORITY_OR_OTHER|||||||0.007||95.0|||||t-test, 1 sided|||||||0.007
72408925|NCT01848990|144326337|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|0.0||||0.9744|TWO_SIDED|95.0|-0.6|0.6||Close personal relationship|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII|||0.6|-0.6|0.9744
72408926|NCT01848990|144326337|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|0.3||||0.3177|TWO_SIDED|95.0|-0.3|0.8||Sex life|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII|||0.8|-0.3|0.3177
72408927|NCT01848990|144326337|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|0.3||||0.2087|TWO_SIDED|95.0|-0.2|0.7||Physical appearance|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII|||0.7|-0.2|0.2087
72408928|NCT01848990|144326337|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|0.1||||0.7907|TWO_SIDED|95.0|-0.4|0.5||Self-confidence|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII|||0.5|-0.4|0.7907
72408929|NCT01848990|144326337|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|-0.3||||0.3444|TWO_SIDED|95.0|-0.8|0.3||Motivation|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII|||0.3|-0.8|0.3444
72408930|NCT01848990|144326337|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|0.2||||0.2175|TWO_SIDED|95.0|-0.1|0.6||The way people in general react|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII|||0.6|-0.1|0.2175
72408931|NCT01848990|144326337|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|-0.4||||0.2062|TWO_SIDED|95.0|-1.0|0.2||Feelings about the future|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII|||0.2|-1.0|0.2062
72408932|NCT01848990|144326337|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|0.0||||0.8762|TWO_SIDED|95.0|-0.5|0.6||Financial situation|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII|||0.6|-0.5|0.8762
72408933|NCT01848990|144326337|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|0.0||||0.89|TWO_SIDED|95.0|-0.5|0.5||Living situation and conditions|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII|||0.5|-0.5|0.8900
72408934|NCT01848990|144326337|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|-0.5||||0.1367|TWO_SIDED|95.0|-1.1|0.2||Depend on others|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII|||0.2|-1.1|0.1367
72408935|NCT01848990|144326337|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|0.3||||0.3144|TWO_SIDED|95.0|-0.3|0.9||Freedom to eat|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII|||0.9|-0.3|0.3144
72536648|NCT01783860|144603564|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||t-test, 1 sided|||||||> 0.05
72536649|NCT01783860|144603565|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||t-test, 1 sided|||||||0.02
72536650|NCT01783860|144603566|SUPERIORITY_OR_OTHER|||||||0.08||95.0|||||t-test, 1 sided|||||||0.08
72536651|NCT00258310|144603575|SUPERIORITY_OR_OTHER_LEGACY||proportion|0.74|||||TWO_SIDED|95.0|0.59|0.9||||||||.90|.59|
72536652|NCT00256217|144603579|OTHER||Mean Difference (Final Values)|4.9||||0.004|TWO_SIDED|95.0|1.8|8.0|||Wilcoxon (Mann-Whitney)|||||8.0|1.8|0.004
72536653|NCT00256217|144603580|OTHER||Mean Difference (Final Values)|0.3||||0.016|TWO_SIDED|95.0|0.1|0.49|||Wilcoxon (Mann-Whitney)|||||0.49|0.10|0.016
72536654|NCT01139801|144603604|SUPERIORITY||Mean Difference (Final Values)|212.2||||0.037|TWO_SIDED|95.0|13.3|411.0|||t-test, 2 sided|||||411.0|13.3|0.037
72536655|NCT03387267|144603615|OTHER||AUC under ROC curve|0.64|||||ONE_SIDED|95.0||0.72||||||||0.72||
72536656|NCT03387267|144603616|OTHER||AUC under ROC curve|0.65|||||TWO_SIDED|||||||||||||
72536657|NCT03387267|144603617|OTHER||AUC under ROC curve|0.576|||||TWO_SIDED|||||||||||||
72536658|NCT03159611|144603637|SUPERIORITY|||||||0.002|||||||Fisher Exact|||||||0.002
72536659|NCT03159611|144603638|SUPERIORITY|||||||0.005|||||||Cochran-Mantel-Haenszel|||||||0.005
72536660|NCT03159611|144603639|SUPERIORITY|||||||0.5|||||||Mixed Models Analysis|||||||0.50
72408936|NCT01848990|144326337|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|0.1||||0.6869|TWO_SIDED|95.0|-0.4|0.6||Freedom to drink|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII|||0.6|-0.4|0.6869
72536661|NCT03159611|144603640|SUPERIORITY|||||||0.2|||||||Cochran-Mantel-Haenszel|||||||0.20
72536662|NCT03159611|144603641|SUPERIORITY|||||||0.19|||||||Wilcoxon (Mann-Whitney)|||||||0.19
72536663|NCT01418365|144603656|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|If the 90% Confidence Intervals of the geometric mean ratio are wholly contained within the interval (0.80, 1.25), then the hypothesis of a drug interaction will be rejected.|Geometric Mean ratio|0.979|||||TWO_SIDED|90.0|0.961|0.998|||ANOVA|||||0.998|0.961|
72536664|NCT01418365|144603657|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|If the 90% Confidence Intervals of the geometric mean ratio are wholly contained within the interval (0.80, 1.25), then the hypothesis of a drug interaction will be rejected.|Geometric Mean Ratio|0.993|||||TWO_SIDED|90.0|0.951|1.04|||ANOVA|||||1.04|0.951|
72536665|NCT03226366|144603694|SUPERIORITY||Mean Difference (Final Values)|-7.9||||0.29|TWO_SIDED|95.0|-20.4|6.1|||Regression, Linear||Change in emergency department door-to-antibiotic time (minutes) based on adjusted differences-in-differences analysis|Differences-in-differences analysis using multivariable regression to estimate the change in emergency department (ED) door-to-antibiotic time after versus before intervention implementation at the intervention site adjusted for the change observed over the same time period at the control sites and for subject's age, sex, Elixhauser Comorbidity Score, initial systolic blood pressure, initial Glasgow Coma Scale score \<14. initial temperature, ED triage acuity score, and ED arrival via ambulance.||6.1|-20.4|0.29
72536666|NCT03226366|144603695|SUPERIORITY||Odds Ratio (OR)|0.81||||0.72|TWO_SIDED|95.0|0.25|2.61|||Regression, Logistic||Odds ratio for hospital mortality after versus before intervention implementation based on adjusted differences-in-differences analysis|Differences-in-differences analysis using multivariable regression to estimate the change in odds of hospital mortality after versus before implementation at the intervention site with adjustment for observed change in outcome over the same time period at the control sites as well as for subject's age, sex, Elixhauser Comorbidity Score, initial systolic blood pressure, an initial Glasgow Coma Scale score \<14. initial temperature, ED triage acuity score, and arrival to the ED via ambulance.||2.61|0.25|0.72
72536667|NCT03226366|144603696|SUPERIORITY||Mean Difference (Final Values)|-9.5||||0.26|TWO_SIDED|95.0|-25.9|7.0|||Regression, Linear||Change in emergency department length of stay (minutes) after versus before intervention implementation based on adjusted differences-in-differences analysis|Differences-in-differences analysis using multivariable regression to estimate the change in emergency department length of stay after versus before implementation at the intervention site with adjustment for the change observed over the same time period at the control sites as well as for subject's age, sex, Elixhauser Comorbidity Score, initial systolic blood pressure, an initial Glasgow Coma Scale score \<14. initial temperature, ED triage acuity score, and arrival to the ED via ambulance.||7.0|-25.9|0.26
72536668|NCT03226366|144603697|SUPERIORITY||Mean Difference (Final Values)|-0.8||||0.55|TWO_SIDED|95.0|-3.3|1.8|||Regression, Linear||Estimated change in emergency department door-to-physician evaluation time (minutes) after versus before intervention implementation based on adjusted differences-in-differences analysis|Differences-in-differences analysis using multivariable regression to estimate the change in emergency department (ED) door-to-physician evaluation time after versus before implementation at the intervention site adjusted for the change observed over the same time period at the control sites and for subject's age, sex, Elixhauser Comorbidity Score, initial systolic blood pressure, initial Glasgow Coma Scale score \<14. initial temperature, ED triage acuity score, and ED arrival via ambulance.||1.8|-3.3|0.55
72536669|NCT03000075|144603700|OTHER|Cochran-Mantel-Haenszel test adjusted for strata: weight (≤ 90 kg vs \> 90 kg) and concomitant psoriatic arthritis (PsA) at Baseline (YES: DIAGNOSED or SUSPECTED vs NO). If there was a stratum containing zero count, 0.1 was added to each cell.|Adjusted percentage difference|73.6|||<|0.001|TWO_SIDED|95.0|62.2|85.0||P-value was calculated from the Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% confidence interval (CI) for adjusted difference of 2 treatment groups, calculated from the Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.|||85.0|62.2|< 0.001
72536670|NCT03000075|144603700|OTHER|Cochran-Mantel-Haenszel test adjusted for strata: weight (≤ 90 kg vs \> 90 kg) and concomitant PsA at Baseline (YES: DIAGNOSED or SUSPECTED vs NO). If there was a stratum containing zero count, 0.1 was added to each cell.|Adjusted percentage difference|72.4|||<|0.001|TWO_SIDED|95.0|60.6|84.1||P-value was calculated from the Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% CI for adjusted difference of 2 treatment groups, calculated from the Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.|||84.1|60.6|< 0.001
72536671|NCT03000075|144603702|OTHER||Adjusted percentage difference|75.0|||<|0.001|TWO_SIDED|95.0|63.8|86.2||P-value was calculated from the Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% CI for adjusted difference of 2 treatment groups, calculated from the Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel test adjusted for strata: weight (≤ 90 kg vs \> 90 kg) and concomitant PsA at Baseline (YES: DIAGNOSED or SUSPECTED vs NO). If there was a stratum containing zero count, 0.1 was added to each cell.||86.2|63.8|< 0.001
72408937|NCT01848990|144326338|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|0.0||||0.9901|TWO_SIDED|95.0|-0.3|0.3|||ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII|||0.3|-0.3|0.9901
72408938|NCT01848990|144326339|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|0.1||||0.9081|TWO_SIDED|95.0|-1.1|1.3||DTSQs|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII|||1.3|-1.1|0.9081
72408939|NCT01848990|144326339|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|0.0||||0.984|TWO_SIDED|95.0|-1.5|1.6||DTSQc|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII|||1.6|-1.5|0.9840
72536672|NCT03000075|144603702|OTHER||Adjusted percentage difference|82.4|||<|0.001|TWO_SIDED|95.0|72.2|92.6||P-value was calculated from the Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% CI for adjusted difference of 2 treatment groups, calculated from the Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel test adjusted for strata: weight (≤ 90 kg vs \> 90 kg) and concomitant PsA at Baseline (YES: DIAGNOSED or SUSPECTED vs NO). If there was a stratum containing zero count, 0.1 was added to each cell.||92.6|72.2|< 0.001
72536673|NCT03000075|144603704|OTHER||Adjusted percentage difference|80.3|||<|0.001|TWO_SIDED|95.0|70.1|90.4||P-value was calculated from the Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% CI for adjusted difference of 2 treatment groups, calculated from the Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel test adjusted for strata: weight (≤ 90 kg vs \> 90 kg) and concomitant PsA at Baseline (YES: DIAGNOSED or SUSPECTED vs NO). If there was a stratum containing zero count, 0.1 was added to each cell.||90.4|70.1|< 0.001
72536674|NCT03000075|144603704|OTHER||Adjusted percentage difference|86.0|||<|0.001|TWO_SIDED|95.0|76.8|95.1||P-value was calculated from the Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% CI for adjusted difference of 2 treatment groups, calculated from the Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel test adjusted for strata: weight (≤ 90 kg vs \> 90 kg) and concomitant PsA at Baseline (YES: DIAGNOSED or SUSPECTED vs NO). If there was a stratum containing zero count, 0.1 was added to each cell.||95.1|76.8|< 0.001
72536675|NCT03000075|144603706|OTHER||Adjusted percentage difference|22.6|||<|0.001|TWO_SIDED|95.0|11.8|33.4||P-value was calculated from the Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% CI for adjusted difference of 2 treatment groups, calculated from the Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel test adjusted for strata: weight (≤ 90 kg vs \> 90 kg) and concomitant PsA at Baseline (YES: DIAGNOSED or SUSPECTED vs NO). If there was a stratum containing zero count, 0.1 was added to each cell.||33.4|11.8|< 0.001
72536676|NCT03000075|144603706|OTHER||Adjusted percentage difference|32.5|||<|0.001|TWO_SIDED|95.0|20.0|45.0||P-value was calculated from the Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% CI for adjusted difference of 2 treatment groups, calculated from the Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel test adjusted for strata: weight (≤ 90 kg vs \> 90 kg) and concomitant PsA at Baseline (YES: DIAGNOSED or SUSPECTED vs NO). If there was a stratum containing zero count, 0.1 was added to each cell.||45.0|20.0|< 0.001
72536677|NCT03000075|144603708|OTHER||Adjusted percentage difference|39.2||||0.131|TWO_SIDED|95.0|-11.6|90.1||P-value was calculated from the Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% CI for adjusted difference of 2 treatment groups, calculated from the Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel test adjusted for strata: weight (≤ 90 kg vs \> 90 kg) and concomitant PsA at Baseline (YES: DIAGNOSED or SUSPECTED vs NO). If there was a stratum containing zero count, 0.1 was added to each cell.||90.1|-11.6|0.131
72536678|NCT03000075|144603708|OTHER|Cochran-Mantel-Haenszel test adjusted for strata: weight (≤ 90 kg vs \> 90 kg) and concomitant PsA at Baseline (YES: DIAGNOSED or SUSPECTED vs NO). If there was a stratum containing zero count, 0.1 was added to each cell.|Adjusted percentage difference|31.3||||0.269|TWO_SIDED|95.0|-24.2|86.7||P-value was calculated from the Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% CI for adjusted difference of 2 treatment groups, calculated from the Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.|||86.7|-24.2|0.269
72536679|NCT00440193|144603713|NON_INFERIORITY_OR_EQUIVALENCE|Assuming equal efficacy, a total of 88 events was calculated to give a power of 90% to prove that rivaroxaban is at least as effective as the comparator, considering a non-inferiority upper CI margin for the hazard ratio of 2.0 (two-sided α=0.05). A mean incidence for the primary efficacy outcome of 3% was expected and at least 1465 participants per group were determined to be necessary. This number was to be adjusted based on the observed overall incidence of symptomatic recurrent VTE.|Hazard Ratio (HR)|0.68|STANDARD_ERROR_OF_MEAN|0.2179|<|0.0001||95.0|0.44|1.04|||Regression, Cox|Stratified by intend treatment duration, adjusted for presence of active malignancy at baseline|The standard error of the log hazard ratio was estimated.|The rivaroxaban to comparator hazard ratio was computed with a 95% CI (confidence interval) (two-sided testing). Based on this model, rivaroxaban would be considered at least as effective as the comparator if the upper limit of the CI was less than 2.0.||1.04|0.44|< 0.0001
72536680|NCT00440193|144603714|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.72|STANDARD_ERROR_OF_MEAN|0.1616||0.044||95.0|0.53|0.99||Nominal p-value|Regression, Cox|Stratified by intend treatment duration, adjusted for presence of active malignancy at baseline.|The standard error of the log hazard ratio was estimated.|||0.99|0.53|0.044
72536681|NCT00440193|144603715|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.67|STANDARD_ERROR_OF_MEAN|0.1828||0.027||95.0|0.47|0.95||Nominal p-value|Regression, Cox|Stratified by intend treatment duration, adjusted for presence of active malignancy at baseline.|The standard error of the log hazard ratio was estimated.|||0.95|0.47|0.027
72573312|NCT03433755|144673229|SUPERIORITY||Treatment difference|-15.74|STANDARD_ERROR_OF_MEAN|5.33|<|0.0001|TWO_SIDED|95.0|-26.31|-5.18||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit as covariates.|Treatment difference = Evolocumab QM - Placebo QM|||-5.18|-26.31|< 0.0001
72573313|NCT05205772|144673237|OTHER|||||||0.08|||||||Wilcoxon (Mann-Whitney)|||||||0.08
72408940|NCT04497987|144326345|SUPERIORITY||Odds Ratio (OR)|0.4|||<|0.001|TWO_SIDED|95.0|0.26|0.63|||Regression, Logistic|||||0.63|0.26|<0.001
72408941|NCT04497987|144326346|SUPERIORITY||Odds Ratio (OR)|0.43|||<|0.001|TWO_SIDED|95.0|0.27|0.67|||Regression, Logistic|||||0.67|0.27|<0.001
72408942|NCT04497987|144326347|SUPERIORITY||Odds Ratio (OR)|0.66||||0.021|TWO_SIDED|95.0|0.46|0.94|||Regression, Logistic|||||0.94|0.46|0.021
72408943|NCT01312909|144326367|SUPERIORITY||Odds Ratio (OR)|1.18||||0.6337|TWO_SIDED|95.0|0.59|2.37||Threshold for significance at 0.05 level.|Regression, Logistic|||Odds ratios and p-values were obtained from a logistic regression model with terms treatment, age strata, body weight strata and pooled center. A testing order was used to control type I error. 1mg Varenicline twice daily group was tested against placebo first, and if statistically significant difference was observed, the 0.5 mg Varenicline twice daily group was tested against placebo.||2.37|0.59|0.6337
72408944|NCT01312909|144326367|SUPERIORITY||Odds Ratio (OR)|1.73||||0.1114|TWO_SIDED|95.0|0.88|3.39||Threshold for significance at 0.05 level.|Regression, Logistic|||Odds ratios and p-values were obtained from a logistic regression model with terms treatment, age strata, body weight strata and pooled center. A testing order was used to control type I error. 1mg Varenicline twice daily group was tested against placebo first, and if statistically significant difference was observed, the 0.5 mg Varenicline twice daily group was tested against placebo.||3.39|0.88|0.1114
72408945|NCT01312909|144326368|SUPERIORITY||Odds Ratio (OR)|1.21||||0.5793|TWO_SIDED|95.0|0.62|2.38|||Regression, Logistic|Odds ratios and p-values were obtained from separate logistic regression models of treatment, pooled center, age strata and body weight strata.||Week 12||2.38|0.62|0.5793
72536682|NCT00440193|144603717|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.97|STANDARD_ERROR_OF_MEAN|0.1204||0.77||95.0|0.76|1.22||Nominal p-value|Regression, Cox|Stratified by intend treatment duration, adjusted for presence of active malignancy at baseline.|The standard error of the log hazard ratio was estimated.|||1.22|0.76|0.77
72536683|NCT02222168|144603731|OTHER|The statistical model used for the analysis of the endpoint comparing 'BI 409306 fasted' against 'BI 409306 fed' was an Analysis of Variance (ANOVA ) model on the logarithmic scale.This model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|Ratio (Fed/Fasted)|95.9|STANDARD_ERROR_OF_MEAN|50.7|||TWO_SIDED|90.0|72.593|126.682|||||The estimated parameter was the adjusted geometric mean ratios \[%\] of BI 409306: fed (numerator), fasted (denominator). The standard deviation is the intra-individual geometric coefficient of variation \[%\].|No formal hypothesis was tested.||126.682|72.593|
72536684|NCT02222168|144603731|OTHER|The statistical model used for the analysis of the endpoint comparing 'BI 409306 fasted' against 'BI 409306 at bed-time' was an Analysis of Variance (ANOVA ) model on the logarithmic scale. This model included effects accounting for the following sources of variation: 'subject' and 'treatment'. The effect 'subject' was considered as random, whereas the effect treatment was considered as fixed.|Ratio (Bed time/Fasted)|82.13|STANDARD_ERROR_OF_MEAN|38.0|||TWO_SIDED|90.0|66.37|101.639|||||The estimated parameter was the adjusted geometric mean ratios \[%\] of BI 409306: at bed time (numerator), fasted (denominator). The standard deviation is the intra-individual geometric coefficient of variation \[%\].|No formal hypothesis was tested.||101.639|66.370|
72536685|NCT02222168|144603732|OTHER|The statistical model used for the analysis of the endpoint comparing 'BI 409306 fasted' against 'BI 409306 fed' was an Analysis of Variance (ANOVA ) model on the logarithmic scale.This model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|Ratio (Fed/Fasted)|107.41|STANDARD_ERROR_OF_MEAN|18.2|||TWO_SIDED|90.0|96.697|119.318|||||The estimated parameter was the adjusted geometric mean ratios \[%\] of BI 409306: fed (numerator), fasted (denominator). The standard deviation is the intra-individual geometric coefficient of variation \[%\].|No formal hypothesis was tested.||119.318|96.697|
72573314|NCT05205772|144673237|OTHER|||||||0.54|||||||Wilcoxon (Mann-Whitney)|||||||0.54
72408946|NCT01312909|144326368|SUPERIORITY||Odds Ratio (OR)|1.79||||0.0932|TWO_SIDED|95.0|0.91|3.51|||Regression, Logistic|Odds ratios and p-values were obtained from separate logistic regression models of treatment, pooled center, age strata and body weight strata.||Week 12||3.51|0.91|0.0932
72408947|NCT01312909|144326368|SUPERIORITY||Odds Ratio (OR)|1.23||||0.5647|TWO_SIDED|95.0|0.61|2.5|||Regression, Logistic|Odds ratios and p-values were obtained from separate logistic regression models of treatment, pooled center, age strata and body weight strata.||Week 24||2.50|0.61|0.5647
72408948|NCT01312909|144326368|SUPERIORITY||Odds Ratio (OR)|1.46||||0.2917|TWO_SIDED|95.0|0.72|2.96|||Regression, Logistic|Odds ratios and p-values were obtained from separate logistic regression models of treatment, pooled center, age strata and body weight strata.||Week 24||2.96|0.72|0.2917
72408949|NCT01312909|144326368|SUPERIORITY||Odds Ratio (OR)|1.25||||0.5616|TWO_SIDED|95.0|0.58|2.69|||Regression, Logistic|Odds ratios and p-values were obtained from separate logistic regression models of treatment, pooled center, age strata and body weight strata.||Week 52||2.69|0.58|0.5616
72408950|NCT01312909|144326368|SUPERIORITY||Odds Ratio (OR)|1.79||||0.13|TWO_SIDED|95.0|0.84|3.78|||Regression, Logistic|Odds ratios and p-values were obtained from separate logistic regression models of treatment, pooled center, age strata and body weight strata.||Week 52||3.78|0.84|0.1300
72408951|NCT01312909|144326370|SUPERIORITY||Least square (LS) mean difference|-0.54|STANDARD_ERROR_OF_MEAN|0.58||0.354|TWO_SIDED|95.0|-1.69|0.6|||Longitudinal repeated measures model|||Week 12: Analysis was performed using longitudinal repeated measures model with the change from baseline average number of Cigarettes Smoked as the dependent variable, including terms treatment, visit, age strata, body weight strata, pooled center, baseline measure and treatment by visit interaction.||0.60|-1.69|0.3540
72408952|NCT01312909|144326370|SUPERIORITY||LS mean difference|-0.18|STANDARD_ERROR_OF_MEAN|0.59||0.7574|TWO_SIDED|95.0|-1.35|0.98|||Longitudinal repeated measures model|||Week 12: Analysis was performed using longitudinal repeated measures model with the change from baseline average number of Cigarettes Smoked as the dependent variable, including terms treatment, visit, age strata, body weight strata, pooled center, baseline measure and treatment by visit interaction.||0.98|-1.35|0.7574
72408953|NCT01312909|144326370|SUPERIORITY||LS mean difference|-0.34|STANDARD_ERROR_OF_MEAN|0.6||0.5676|TWO_SIDED|95.0|-1.53|0.84|||Longitudinal repeated measures model|||Week 24: Analysis was performed using longitudinal repeated measures model with the change from baseline average number of Cigarettes Smoked as the dependent variable, including terms treatment, visit, age strata, body weight strata, pooled center, baseline measure and treatment by visit interaction.||0.84|-1.53|0.5676
72408954|NCT01312909|144326370|SUPERIORITY||LS mean difference|-0.72|STANDARD_ERROR_OF_MEAN|0.61||0.2356|TWO_SIDED|95.0|-1.92|0.47|||Longitudinal repeated measures model|||Week 24: Analysis was performed using longitudinal repeated measures model with the change from baseline average number of Cigarettes Smoked as the dependent variable, including terms treatment, visit, age strata, body weight strata, pooled center, baseline measure and treatment by visit interaction.||0.47|-1.92|0.2356
72408955|NCT01312909|144326370|SUPERIORITY||LS mean difference|0.18|STANDARD_ERROR_OF_MEAN|0.62||0.773|TWO_SIDED|95.0|-1.03|1.38|||Longitudinal repeated measures model|||Week 52: Analysis was performed using longitudinal repeated measures model with the change from baseline average number of Cigarettes Smoked as the dependent variable, including terms treatment, visit, age strata, body weight strata, pooled center, baseline measure and treatment by visit interaction.||1.38|-1.03|0.7730
72536686|NCT02222168|144603732|OTHER|The statistical model used for the analysis of the endpoint comparing 'BI 409306 fasted' against 'BI 409306 at bed-time' was an Analysis of Variance (ANOVA ) model on the logarithmic scale. This model included effects accounting for the following sources of variation: 'subject' and 'treatment'. The effect 'subject' was considered as random, whereas the effect treatment was considered as fixed.|Ratio (Bed time/Fasted)|94.88|STANDARD_ERROR_OF_MEAN|19.1|||TWO_SIDED|90.0|85.028|105.875|||||The estimated parameter was the adjusted geometric mean ratios \[%\] of BI 409306: at bed time (numerator), fasted (denominator). The standard deviation is the intra-individual geometric coefficient of variation \[%\].|No formal hypothesis was tested.||105.875|85.028|
72536687|NCT02222168|144603733|OTHER|The statistical model used for the analysis of the endpoint comparing 'BI 409306 fasted' against 'BI 409306 fed' was an Analysis of Variance (ANOVA ) model on the logarithmic scale.This model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|Ratio (Fed/Fasted)|107.41|STANDARD_ERROR_OF_MEAN|18.2|||TWO_SIDED|90.0|96.709|119.301|||||The estimated parameter was the adjusted geometric mean ratios \[%\] of BI 409306: fed (numerator), fasted (denominator). The standard deviation is the intra-individual geometric coefficient of variation \[%\].|No formal hypothesis was tested.||119.301|96.709|
72536688|NCT02222168|144603733|OTHER|The statistical model used for the analysis of the endpoint comparing 'BI 409306 fasted' against 'BI 409306 at bed-time' was an Analysis of Variance (ANOVA ) model on the logarithmic scale. This model included effects accounting for the following sources of variation: 'subject' and 'treatment'. The effect 'subject' was considered as random, whereas the effect treatment was considered as fixed.|Ratio (Bed time/Fasted)|94.92|STANDARD_ERROR_OF_MEAN|19.1|||TWO_SIDED|90.0|85.061|105.921|||||The estimated parameter was the adjusted geometric mean ratios \[%\] of BI 409306: at bed time (numerator), fasted (denominator). The standard deviation is the intra-individual geometric coefficient of variation \[%\].|No formal hypothesis was tested.||105.921|85.061|
72536689|NCT00530621|144603734|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.13||||0.544||95.0|0.77|1.65||P-value was stratified by Eastern Cooperative Oncology Group (ECOG) performance status and time since last chemotherapy.|Log Rank|||||1.65|0.77|0.544
72536690|NCT00530621|144603735|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.7||||0.171||95.0|0.42|1.17||P-value was stratified by Eastern Cooperative Oncology Group (ECOG) performance status and time since last chemotherapy.|Log Rank|||||1.17|0.42|0.171
72536691|NCT00530621|144603736|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|2.11||||0.01||95.0|1.19|3.75|||Regression, Cox|||||3.75|1.19|0.010
72536692|NCT00530621|144603737|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.5||||0.194||95.0|0.81|2.77||P-value was stratified by Eastern Cooperative Oncology Group (ECOG) performance status score and time since last chemotherapy.|Log Rank|||||2.77|0.81|0.194
72536693|NCT00530621|144603738|SUPERIORITY_OR_OTHER_LEGACY|||||||0.681|||||||Fisher Exact|||||||0.681
72536694|NCT02596009|144603742|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|26.97|||<|0.0001|TWO_SIDED|95.0|23.7|30.24|||paired t-test|||||30.24|23.70|<0.0001
72536695|NCT02596009|144603742|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|53.93|||<|0.0001|TWO_SIDED|95.0|49.15|58.72|||paired t-test|||||58.72|49.15|<0.0001
72536696|NCT03409328|144603746|OTHER||F|38.44|||<|0.001|TWO_SIDED||||||ANCOVA|The ANCOVA controlled for baseline levels of the outcome.||||||<.001
72536697|NCT03409328|144603747|OTHER||F|6.69||||0.013|TWO_SIDED||||||ANCOVA|The ANCOVA controlled for baseline levels of the outcome.||||||.013
72573315|NCT05205772|144673237|OTHER|||||||0.03|||||||Wilcoxon (Mann-Whitney)|||||||0.03
72408956|NCT01312909|144326370|SUPERIORITY||LS mean difference|-0.77|STANDARD_ERROR_OF_MEAN|0.62||0.2166|TWO_SIDED|95.0|-1.99|0.45|||Longitudinal repeated measures model|||Week 52: Analysis was performed using longitudinal repeated measures model with the change from baseline average number of Cigarettes Smoked as the dependent variable, including terms treatment, visit, age strata, body weight strata, pooled center, baseline measure and treatment by visit interaction.||0.45|-1.99|0.2166
72536698|NCT03409328|144603748|OTHER||F|5.07||||0.029|TWO_SIDED||||||ANCOVA|The ANCOVA controlled for baseline levels of the outcome.||||||.029
72536699|NCT03409328|144603749|OTHER||F|0.38||||0.542|TWO_SIDED||||||ANCOVA|The ANCOVA controlled for baseline levels of the outcome.||||||.542
72536700|NCT03409328|144603750|OTHER||F|3.12||||0.084|TWO_SIDED||||||ANCOVA|The ANCOVA controlled for baseline levels of the outcome.||The outcome for this analysis is internalized stigma.||||.084
72573316|NCT05205772|144673237|SUPERIORITY|||||||0.98|||||||ANOVA|||||||0.98
72408957|NCT01312909|144326371|SUPERIORITY||Odds Ratio (OR)|0.8||||0.6133|TWO_SIDED|95.0|0.34|1.9|||Regression, Logistic|||Week 9 through Week 24: Odds ratios and p-values were obtained from a logistic regression model including the main effects of treatment, pooled center, age strata and body weight strata.||1.90|0.34|0.6133
72536701|NCT03409328|144603750|OTHER||F|0.67||||0.417|TWO_SIDED||||||ANCOVA|The ANCOVA controlled for baseline levels of the outcome.||The outcome for this analysis is identity affirmation.||||.417
72536702|NCT00518011|144603753|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.842||||0.3644|TWO_SIDED|95.0|0.483|7.027|||Log Rank|||||7.027|0.483|0.3644
72536703|NCT00518011|144603757|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.278||||0.7165|TWO_SIDED|95.0|0.339|4.824|||Log Rank|||||4.824|0.339|0.7165
72573317|NCT05205772|144673237|SUPERIORITY|||||||0.41|||||||ANOVA|||||||0.41
72573318|NCT05205772|144673237|SUPERIORITY|||||||0.63|||||||ANOVA|||||||0.63
72573319|NCT05205772|144673238|OTHER|||||||0.38||||||Adjusted for age.|Regression, Linear|||||||0.38
72573320|NCT05205772|144673239|OTHER|||||||0.67||||||Adjusted for age.|Regression, Linear|||||||0.67
72408958|NCT01312909|144326371|SUPERIORITY||Odds Ratio (OR)|2.26||||0.0335|TWO_SIDED|95.0|1.07|4.79|||Regression, Logistic|||Week 9 through Week 24: Odds ratios and p-values were obtained from a logistic regression model including the main effects of treatment, pooled center, age strata and body weight strata.||4.79|1.07|0.0335
72536704|NCT03930615|144603779|SUPERIORITY||Treatment Difference|-16.1||||0.0005|TWO_SIDED|95.0|-25.8|-6.5||A one-sided p-value ≤0.0249 was used for declaring statistical significance|Mantel Haenszel|Stratum adjusted|Letermovir minus placebo|It was hypothesized that LET is superior to placebo in the prevention of clinically significant CMV infection.|95% CIs for the treatment differences in percent response were calculated using stratum adjusted Mantel Haenszel method with the difference weighted by the harmonic mean of sample size per arm for each stratum (haploidentical donor yes or no).|-6.5|-25.8|0.0005
72536705|NCT03930615|144603780|OTHER||Difference in Percentage|-4.4|||||TWO_SIDED|95.0|-11.8|4.7|||||Letermovir minus Placebo||Miettinen \& Nurminen method|4.7|-11.8|
72536706|NCT03930615|144603781|OTHER||Difference in Percentage|3.5|||||TWO_SIDED|95.0|-2.7|8.6|||||Letermovir minus Placebo||Miettinen \& Nurminen method|8.6|-2.7|
72573321|NCT05205772|144673240|OTHER|||||||0.156|||||||Regression, Linear|||||||0.156
72573322|NCT04994483|144673252|SUPERIORITY||Mean Difference (Final Values)|-0.39||||0.4308|TWO_SIDED|95.0|-1.37|0.59|||Mixed Models Analysis|||||0.59|-1.37|0.4308
72573323|NCT04994483|144673253|SUPERIORITY||Mean Difference (Final Values)|0.51||||0.4034|TWO_SIDED|95.0|-0.68|1.7|||Mixed Models Analysis|||||1.70|-0.68|0.4034
72573324|NCT03589768|144673264|OTHER|N/A, Only risk difference estimated and 95% CI reported.|Risk Difference (RD)|0.1|||||TWO_SIDED|95.0|-11.9|10.3|||||Difference is calculated as the proportion in the BOOSTRIX group minus the proportion in the Td group.|||10.3|-11.9|
72573325|NCT03589768|144673265|SUPERIORITY||Risk Difference (RD)|4.62||||0.559|TWO_SIDED|95.0|-6.25|15.5|||Fisher Exact||Difference is calculated as the proportion in the BOOSTRIX group minus the proportion in the Td group.|||15.5|-6.25|0.559
72573326|NCT03589768|144673266|OTHER|Only risk difference estimated and 95% CI reported.|Risk Difference (RD)|1.2|||||TWO_SIDED|95.0|-9.3|9.8|||||||Difference is calculated as the proportion in the BOOSTRIX group minus the proportion in the Td group.|9.8|-9.3|
72573327|NCT03589768|144673267|SUPERIORITY||Risk Difference (RD)|6.06||||0.29|TWO_SIDED|95.0|-3.82|15.9|||Fisher Exact||||Difference is calculated as the proportion in the BOOSTRIX group minus the proportion in the Td group.|15.9|-3.82|0.290
72573328|NCT03589768|144673269|OTHER|Only risk difference estimated and 95% CI reported.|Risk Difference (RD)|1.5|||||TWO_SIDED|95.0|-6.4|7.3|||||||Difference is calculated as the proportion in the BOOSTRIX group minus the proportion in the Td group.|7.3|-6.4|
72573329|NCT03589768|144673270|SUPERIORITY||Ratio|7.0|||<|0.0001|TWO_SIDED|95.0|4.6|10.7|||t-test, 2 sided|Test compares difference in log values.|Difference in log values back transformed into ratio.|Statistical analysis for birth day timepoint|The ratio is calculated as the GMC of the BOOSTRIX group divided by the GMC of the Td group.|10.7|4.6|<0.0001
72573330|NCT03589768|144673270|SUPERIORITY||Ratio|4.8|||<|0.0001|TWO_SIDED|95.0|3.2|7.3|||t-test, 2 sided|Test compares difference in log values.|Difference in log values back transformed into ratio.|Statistical analysis for Prior to receipt of first dose of DTwP (approximately 6 weeks of age) timepoint|The ratio is calculated as the GMC of the BOOSTRIX group divided by the GMC of the Td group.|7.3|3.2|<0.0001
72573331|NCT03589768|144673270|SUPERIORITY||Ratio|2.9|||<|0.0001|TWO_SIDED|95.0|1.8|4.8|||t-test, 2 sided|Test compares difference in log values.|Difference in log values back transformed into ratio.|Statistical analysis for One month after receipt of first dose of DTwP (approximately 10 weeks of age) timepoint|The ratio is calculated as the GMC of the BOOSTRIX group divided by the GMC of the Td group.|4.8|1.8|<0.0001
72573332|NCT03589768|144673270|SUPERIORITY||Ratio|0.3||||0.0068|TWO_SIDED|95.0|0.1|0.7|||t-test, 2 sided|Test compares difference in log values.|Difference in log values back transformed into ratio.|Statistical analysis for One month after receipt of last dose of DTwP (approximately 18 weeks of age) time point|The ratio is calculated as the GMC of the BOOSTRIX group divided by the GMC of the Td group.|0.7|0.1|0.0068
72573333|NCT03589768|144673270|SUPERIORITY||Ratio|0.3||||0.0003|TWO_SIDED|95.0|0.1|0.5|||t-test, 2 sided|Test compares differences in log values.|Difference in log values back transformed into ratio.|Statistical analysis for 6 months of age time point|The ratio is calculated as the GMC of the BOOSTRIX group divided by the GMC of the Td group.|0.5|0.1|0.0003
72573334|NCT03589768|144673271|SUPERIORITY||Ratio|0.9||||0.7102|TWO_SIDED|95.0|0.7|1.3|||t-test, 2 sided|Test compares difference in log values.|Difference in log values back transformed into ratio.|Statistical analysis for pre-vaccination time point|The ratio is calculated as the GMC of the BOOSTRIX group divided by the GMC of the Td group.|1.3|0.7|0.7102
72573335|NCT03589768|144673271|SUPERIORITY||Ratio|8.7|||<|0.0001|TWO_SIDED|95.0|6.2|12.0|||t-test, 2 sided|Test compares difference in log values.|Difference in log values back transformed into ratio.|Statistical analysis for one month after vaccination time point|The ratio is calculated as the GMC of the BOOSTRIX group divided by the GMC of the Td group.|12.0|6.2|<0.0001
72626687|NCT02164864|144782258|OTHER||Hazard Ratio (HR)|1.86||||0.1546|TWO_SIDED|95.0|0.79|4.4||Wald 2-sided p-value from (stratified) Cox proportional hazards model|Regression, Cox|The Cox proportional hazard model is stratified by age, non-elderly vs elderly \[\<70 or \>=70 in Japan and \<80 or \>=80 years old elsewhere\].|Hazard Ratio (HR) and Wald confidence intervals are derived from a Cox proportional-hazard model|||4.40|0.79|0.1546
72626688|NCT02164864|144782258|OTHER||Hazard Ratio (HR)|0.99||||0.9789|TWO_SIDED|95.0|0.35|2.81||Wald 2-sided p-value from (unstratified) Cox proportional hazards model|Regression, Cox|unstratified Cox proportional hazards model was used and elderly patients outside the USA were excluded from|Hazard Ratio (HR) and Wald confidence intervals are derived from a Cox proportional-hazard model|||2.81|0.35|0.9789
72626689|NCT02164864|144782259|OTHER||Hazard Ratio (HR)|1.34||||0.0484|TWO_SIDED|95.0|1.0|1.79||Wald 2-sided p-value from (stratified) Cox proportional hazards model|Regression, Cox|The Cox proportional hazard model is stratified by age, non-elderly vs elderly \[\<70 or \>=70 in Japan and \<80 or \>=80 years old elsewhere\].|Hazard Ratio (HR) and Wald confidence intervals are derived from a Cox proportional-hazard model|||1.79|1.00|0.0484
72626690|NCT02164864|144782259|OTHER||Hazard Ratio (HR)|1.03||||0.8903|TWO_SIDED|95.0|0.71|1.47||Wald 2-sided p-value from (unstratified) Cox proportional hazards model|Regression, Cox|unstratified Cox proportional hazards model was used and elderly patients outside the USA were excluded from|Hazard Ratio (HR) and Wald confidence intervals are derived from a Cox proportional-hazard model|||1.47|0.71|0.8903
72536707|NCT03930615|144603782|SUPERIORITY||Treatment Difference|-5.7||||0.1591|TWO_SIDED|95.0|-16.8|5.4|||Mantel Haenszel|Stratum adjusted|Letermovir minus placebo||95% CIs for the treatment differences in percent response were calculated using stratum adjusted Mantel Haenszel method with the difference weighted by the harmonic mean of sample size per arm for each stratum (haploidentical donor yes or no).|5.4|-16.8|0.1591
72626691|NCT02164864|144782260|NON_INFERIORITY|All non-inferiority tests were based on a margin of 1.38.|Hazard Ratio (HR)|1.17||||0.1128|TWO_SIDED|95.0|0.9|1.53||P values for noninferiority were calculated at a one-sided alpha level of 0.025|Regression, Cox|The Cox proportional hazard model is stratified by age, non-elderly vs elderly \[\<70 or \>=70 in Japan and \<80 or \>=80 years old elsewhere\].|The upper bound of the Wald confidence interval (CI) of the HR of All Dabigatran Etexilate (110mg and 150 mg) vs Warfarin (one-sided 97.5%) was compared with this noninferiority margin for the testing of non-inferiority|A pre-defined hierarchical testing approach was used. This was the fifth step in hierarchy.||1.53|0.90|0.1128
72408959|NCT01312909|144326371|SUPERIORITY||Odds Ratio (OR)|0.99||||0.9874|TWO_SIDED|95.0|0.37|2.65|||Regression, Logistic|||Week 9 through Week 52: Odds ratios and p-values were obtained from a logistic regression model including the main effects of treatment, pooled center, age strata and body weight strata.||2.65|0.37|0.9874
72536708|NCT03930615|144603783|SUPERIORITY||Treatment Difference|-5.7||||0.1591|TWO_SIDED|95.0|-16.8|5.4|||Mantel Haenszel|Stratum adjusted|Letermovir minus placebo||95% CIs for the treatment differences in percent response were calculated using stratum adjusted Mantel Haenszel method with the difference weighted by the harmonic mean of sample size per arm for each stratum (haploidentical donor yes or no).|5.4|-16.8|0.1591
72573336|NCT03589768|144673271|SUPERIORITY||Ratio|4.7|||<|0.0001|TWO_SIDED|95.0|3.3|6.6|||t-test, 2 sided|Test compares difference in log values.|Difference in log values back transformed into ratio.|Statistical analysis for delivery time point|The ratio is calculated as the GMC of the BOOSTRIX group divided by the GMC of the Td group.|6.6|3.3|<0.0001
72573337|NCT03589768|144673271|SUPERIORITY||Ratio|3.3|||<|0.0001|TWO_SIDED|95.0|2.1|5.2|||t-test, 2 sided|Test compares difference in log values.|Difference in log values back transformed into ratio.|Statistical analysis for 6 months after delivery time point|The ratio is calculated as the GMC of the BOOSTRIX group divided by the GMC of the Td group.|5.2|2.1|<0.0001
72573338|NCT03589768|144673272|SUPERIORITY||Ratio|1.1||||0.7039|TWO_SIDED|95.0|0.8|1.4|||t-test, 2 sided|Test compares difference in log values.|Difference in log values back transformed into ratio.|Statistical analysis for pre-vaccination time point|The ratio is calculated as the GMC of the BOOSTRIX group divided by the GMC of the Td group.|1.4|0.8|0.7039
72573339|NCT03589768|144673272|SUPERIORITY||Ratio|18.5|||<|0.0001|TWO_SIDED|95.0|14.0|24.3|||t-test, 2 sided|Test compares difference in log values.|Difference in log values back transformed into ratio.|Statistical analysis for one month after vaccination time point|The ratio is calculated as the GMC of the BOOSTRIX group divided by the GMC of the Td group.|24.3|14.0|<0.0001
72573340|NCT03589768|144673272|SUPERIORITY||Ratio|10.5|||<|0.0001|TWO_SIDED|95.0|8.1|13.7|||t-test, 2 sided|Test compares difference in log values.|Difference in log values back transformed into ratio.|Statistical analysis for delivery time point|The ratio is calculated as the GMC of the BOOSTRIX group divided by the GMC of the Td group.|13.7|8.1|<0.0001
72626692|NCT02164864|144782260|OTHER||Hazard Ratio (HR)|1.3||||0.072|TWO_SIDED|95.0|0.98|1.73||Wald 2-sided p-value from (stratified) Cox proportional hazards model|Regression, Cox|The Cox proportional hazard model is stratified by age, non-elderly vs elderly \[\<70 or \>=70 in Japan and \<80 or \>=80 years old elsewhere\].|Hazard Ratio (HR) and Wald confidence intervals are derived from a Cox proportional-hazard model|||1.73|0.98|0.0720
72536709|NCT03930615|144603786|SUPERIORITY||Treatment difference|-14.1||||0.0012|TWO_SIDED|95.0|-23.3|-5.0|||Mantel Haenszel|Stratum adjusted|Letermovir minus placebo||95% CIs for the treatment differences in percent response were calculated using stratum adjusted Mantel Haenszel method with the difference weighted by the harmonic mean of sample size per arm for each stratum (haploidentical donor yes or no).|-5.0|-23.3|0.0012
72573341|NCT03589768|144673272|SUPERIORITY||Ratio|7.4|||<|0.0001|TWO_SIDED|95.0|5.0|11.1|||t-test, 2 sided|Difference in log values back transformed into ratio.||Statistical analysis for 6 months after delivery time point|The ratio is calculated as the GMC of the BOOSTRIX group divided by the GMC of the Td group.|11.1|5.0|<0.0001
72536710|NCT03930615|144603787|SUPERIORITY||Treatment Difference|-5.7||||0.1494|TWO_SIDED|95.0|-16.5|5.1|||Mantel Haenszel|Stratum adjusted|Letermovir minus placebo||95% CIs for the treatment differences in percent response were calculated using stratum adjusted Mantel Haenszel method with the difference weighted by the harmonic mean of sample size per arm for each stratum (haploidentical donor yes or no).|5.1|-16.5|0.1494
72408960|NCT01312909|144326371|SUPERIORITY||Odds Ratio (OR)|2.79||||0.0188|TWO_SIDED|95.0|1.19|6.55|||Regression, Logistic|||Week 9 through Week 52: Odds ratios and p-values were obtained from a logistic regression model including the main effects of treatment, pooled center, age strata and body weight strata.||6.55|1.19|0.0188
72536711|NCT03930615|144603788|SUPERIORITY||Treatment difference|0.7||||0.6244|TWO_SIDED|95.0|-3.8|5.3|||Mantel Haenszel|Stratum adjusted|Letermovir minus placebo||95% CIs for the treatment differences in percent response were calculated using stratum adjusted Mantel Haenszel method with the difference weighted by the harmonic mean of sample size per arm for each stratum (haploidentical donor yes or no).|5.3|-3.8|0.6244
72536712|NCT03930615|144603789|SUPERIORITY||Treatment Difference|0.3||||0.5264|TWO_SIDED|95.0|-7.9|8.4|||Mantel Haenszel|Stratum adjusted|Letermovir minus placebo||95% CIs for the treatment differences in percent response were calculated using stratum adjusted Mantel Haenszel method with the difference weighted by the harmonic mean of sample size per arm for each stratum (haploidentical donor yes or no).|8.4|-7.9|0.5264
72536713|NCT01281475|144603812|SUPERIORITY|We modeled each outcome variable as a function of treatment (ie, levodopa versus placebo), visit (ie, baseline vs. 12-month follow-up) and the treatment-by-visit interaction; the interaction term tests whether the effect of levodopa treatment over time is significantly greater than that of the placebo group.||||||0.75||||||This was the calculated p value without correction for multiple comparisons|Generalized estimating equations|||We performed generalized estimating equations with an unstructured covariance matrix to account for inter-correlations within measurements on the same participant over time.||||0.75
72536714|NCT04611152|144603814|NON_INFERIORITY|The maximum clinically acceptable true difference between KSI-301 and aflibercept participants to be considered non-inferior is 4.5 ETDRS letters, i.e. the non-inferiority margin|Adjusted mean difference|-3.8|STANDARD_ERROR_OF_MEAN|0.84||0.4162|TWO_SIDED|95.04|-5.47|-2.17|||Mixed Models Analysis|MMRM model with treatment, visit, treatment by visit interaction, randomization stratification factors, and continuous baseline BCVA and OCT CST.||||-2.17|-5.47|0.4162
72536715|NCT04611152|144603815|NON_INFERIORITY|"The maximum clinically acceptable non-inferiority margin between KSI-301 and aflibercept subjects is 10% to be considered non-inferior, i.e. the non-inferiority margin is 10%"|Difference of weighted percentages|0.6|||<|0.0001|TWO_SIDED|95.04|-0.7|2.0|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haentzel test stratified by study identifier and randomization stratification variables.|Weighted percentages are based on weighted average of observed estimates across strata using CMH weights. The CI are based on the normal approximation to the binomial proportions.|||2|-0.7|<0.0001
72573342|NCT03589768|144673273|SUPERIORITY||Ratio|1.2||||0.2897|TWO_SIDED|95.0|0.8|1.8|||t-test, 2 sided|Test compares difference in log values.|Difference in log values back transformed into ratio.|Statistical analysis for pre-vaccination time point|The ratio is calculated as the GMC of the BOOSTRIX group divided by the GMC of the Td group.|1.8|0.8|0.2897
72408961|NCT01777997|144326430|OTHER|||||||0.001|||||||Regression, repeated measures (GEE)|||Estimated mean change from baseline to weeks 24-48 on ART from repeated measures (GEE) model, against the null hypothesis of zero change. Estimated mean represents on ART levels minus pre-ART levels.||||0.001
72408962|NCT00127790|144326439|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.0||||0.01|||||||Generalized Estimating Equations|||Two-tailed comparison of pre-post scores.||||0.010
72408963|NCT00127790|144326439|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.5||||0.581|||||||Generalized Estimating Equations|||Two-tailed comparison of pre-post scores.||||0.581
72408964|NCT00127790|144326439|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.6||||0.011|||||||Generalized Estimating Equations|||Two-tailed comparison of pre-post scores||||0.011
72408965|NCT00127790|144326440|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.5||||0.33|||||||Generalized Estimating Equations|||Two-tailed comparison of pre-post scores.||||0.33
72536716|NCT04611152|144603816|NON_INFERIORITY|"The maximum clinically acceptable non-inferiority margin between KSI-301 and aflibercept subjects is 10% to be considered non-inferior, i.e. the non-inferiority margin is 10%"|Difference of weighted percentages|0.0|||||TWO_SIDED|95.04|0.0|0.0|||||Weighted percentages are based on weighted average of observed estimates across strata using CMH weights. The CI are based on the normal approximation to the binomial proportions.|||0|0|
72536717|NCT02080273|144603832|OTHER|||||||0.919|||||||ANOVA|||Means and standard deviations. 1 factor ANOVA to balance treatment groups to show no difference between groups. The null hypothesis states that there is no difference between groups.||||0.919
72536718|NCT02080273|144603833|SUPERIORITY_OR_OTHER|||||||0.001||||||1 factor ANCOVA to determine difference between groups with baseline as covariate. The F statistic is used to determine significance. If significance is found then a Tukey's multiple comparison is done.|ANCOVA|||The null hypothesis states that there is no difference between groups. ANCOVA adjusting for baseline.||||0.001
72536719|NCT02080273|144603834|SUPERIORITY_OR_OTHER|||||||0.001||||||1 factor ANCOVA to determine difference between groups with baseline as covariate. The F statistic is used to determine significance. If significance is found then a Tukey's multiple comparison is done.|ANCOVA|||The null hypothesis states that there is no difference between groups. ANCOVA adjusting for baseline.||||0.001
72536720|NCT02080273|144603835|OTHER|||||||0.001||||||1 factor ANCOVA to determine difference between groups with baseline as covariate. The F statistic is used to determine significance. If significance is found then a Tukey's multiple comparison is done.|ANCOVA|||The null hypothesis states that there is no difference between groups. ANCOVA adjusting for baseline.||||0.001
72408966|NCT00127790|144326440|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.2||||0.112|||||||Generalized Estimating Equations|||Two-tailed comparison of pre-post scores.||||0.112
72536721|NCT02080273|144603836|OTHER|||||||0.922|||||||ANOVA|||Means and standard deviations. 1 factor ANOVA to balance treatment groups to show no difference between groups. The null hypothesis states that there is no difference between groups.||||0.922
72536722|NCT02080273|144603837|OTHER|||||||0.848||||||1 factor ANCOVA to determine difference between groups with baseline as covariate. The F statistic is used to determine significance. If significance is found then a Tukey's multiple comparison is done.|ANCOVA|||The null hypothesis states that there is no difference between groups. ANCOVA adjusting for baseline||||0.848
72408967|NCT00127790|144326440|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.3||||0.737|||||||Generalized Estimating Equations|||Two-tailed comparison of pre-post scores||||0.737
72408968|NCT00127790|144326441|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.5||||0.063|||||||Generalized Estimating Equations|||Two-tailed comparison of pre-post scores||||0.063
72408969|NCT00127790|144326441|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.4||||0.786|||||||Generalized Estimating Equations|||Two-tailed comparison of pre-post scores||||0.786
72408970|NCT00127790|144326441|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.039|||||||Generalized Estimating Equations|||Two-tailed comparison of pre-post scores.||||0.039
72408971|NCT00127790|144326442|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|15.2||||0.016|||||||Generlaized Estimating Equations|||Two-tailed comparison of pre-post scores.||||0.016
72408972|NCT00127790|144326442|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.4||||0.187|||||||Generalized Estimating Equations|||Two-tailed comparison of pre-post scores.||||0.187
72408973|NCT00127790|144326442|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.2||||0.015|||||||Generalized Estimating Equations|||Two-tailed comparison of pre-post scores.||||0.015
72408974|NCT04086472|144326448|SUPERIORITY||Least squares (LS) Mean Difference|-1.31||||0.808|TWO_SIDED|90.0|-10.25|7.64|||ANOVA|||Treatment vs. Placebo||7.64|-10.25|0.808
72408975|NCT04086472|144326448|SUPERIORITY||LS Mean Difference|-6.51||||0.229|TWO_SIDED|90.0|-15.46|2.43|||ANOVA|||Treatment vs. Placebo||2.43|-15.46|0.229
72408976|NCT04086472|144326448|SUPERIORITY||LS Mean Difference|-4.81||||0.363|TWO_SIDED|90.0|-13.58|3.96|||ANOVA|||Treatment vs. Placebo||3.96|-13.58|0.363
72408977|NCT04086472|144326448|SUPERIORITY||LS Mean Difference|-5.92||||0.273|TWO_SIDED|90.0|-14.87|3.02|||ANOVA|||Treatment vs. Placebo||3.02|-14.87|0.273
72408978|NCT04086472|144326449|OTHER|Treatment vs. Placebo|Difference in percentage|0.51|||||TWO_SIDED|95.0|-36.57|37.78|||||95% CI based on the Chan and Zhang exact method|||37.78|-36.57|
72408979|NCT04086472|144326449|OTHER|Treatment vs. Placebo|Difference in percentage|-22.56|||||TWO_SIDED|95.0|-56.7|15.53|||||95% CI based on the Chan and Zhang exact method|||15.53|-56.70|
72408980|NCT04086472|144326449|OTHER|Treatment vs. Placebo|Difference in percentage|-17.62|||||TWO_SIDED|95.0|-53.09|20.01|||||95% CI based on the Chan and Zhang exact method|||20.01|-53.09|
72408981|NCT04086472|144326449|OTHER|Treatment vs. Placebo|Difference in percentage|-22.56|||||TWO_SIDED|95.0|-56.7|15.53|||||95% CI based on the Chan and Zhang exact method|Treatment vs. Placebo||15.53|-56.70|
72408982|NCT00048724|144326454|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.452||||0.1439||95.0|0.88|2.396|||Cox Proportional Hazards Model|Age (\<= 50 years, \>50 years) and participation in a prior study (yes, no) were stratification factors.|Hazard ratio represents results of untreated control relative to treatment.|The primary scientific hypothesis is that, 0.5 ug/kg subcutaneous once weekly PegIntron as maintenance therapy is efficacious, when compared to no treatment, in the prevention of clinical events in adult subjects with compensated cirrhosis (Metavir F4), secondary to Chronic Hepatitis C, who have failed to respond to therapy with any α interferon plus ribavirin.||2.396|0.880|0.1439
72573343|NCT03589768|144673273|SUPERIORITY||Ratio|54.2|||<|0.0001|TWO_SIDED|95.0|35.6|82.4|||t-test, 2 sided|Test compares difference in log values.|Difference in log values back transformed into ratio.|Statistical analysis for one month after vaccination time point|The ratio is calculated as the GMC of the BOOSTRIX group divided by the GMC of the Td group.|82.4|35.6|<0.0001
72573344|NCT03589768|144673273|SUPERIORITY||Ratio|32.0|||<|0.0001|TWO_SIDED|95.0|20.6|49.7|||t-test, 2 sided|Test compares difference in log values.|Difference in log values back transformed into ratio.|Statistical analysis for delivery time point|The ratio is calculated as the GMC of the BOOSTRIX group divided by the GMC of the Td group.|49.7|20.6|<0.0001
72626693|NCT02164864|144782260|OTHER||Hazard Ratio (HR)|0.97||||0.875|TWO_SIDED|95.0|0.68|1.39||Wald 2-sided p-value from (unstratified) Cox proportional hazards model|Regression, Cox|unstratified Cox proportional hazards model was used and elderly patients outside the USA were excluded|Hazard Ratio (HR) and Wald confidence intervals are derived from a Cox proportional-hazard model|||1.39|0.68|0.8750
72626694|NCT02164864|144782261|OTHER||Hazard Ratio (HR)|1.09||||0.608|TWO_SIDED|95.0|0.79|1.51||Wald 2-sided p-value from (stratified) Cox proportional hazards model|Regression, Cox|The Cox proportional hazard model is stratified by age, non-elderly vs elderly \[\<70 or \>=70 in Japan and \<80 or \>=80 years old elsewhere\].|Hazard Ratio (HR) and Wald confidence intervals are derived from a Cox proportional-hazard model|||1.51|0.79|0.6080
72626695|NCT02164864|144782261|OTHER||Hazard Ratio (HR)|0.96||||0.8348|TWO_SIDED|95.0|0.65|1.41||Wald 2-sided p-value from (unstratified) Cox proportional hazards model|Regression, Cox|unstratified Cox proportional hazards model was used and elderly patients outside the USA were excluded from|Hazard Ratio (HR) and Wald confidence intervals are derived from a Cox proportional-hazard model|||1.41|0.65|0.8348
72626696|NCT02164864|144782262|NON_INFERIORITY|All non-inferiority tests were based on a margin of 1.38.|Hazard Ratio (HR)|1.04||||0.0047|TWO_SIDED|95.0|0.84|1.29||P values for noninferiority were calculated at a one-sided alpha level of 0.025|Regression, Cox|The Cox proportional hazard model is stratified by age, non-elderly vs elderly \[\<70 or \>=70 in Japan and \<80 or \>=80 years old elsewhere\].|The upper bound of the Wald confidence interval (CI) of the HR of All Dabigatran Etexilate (110mg and 150 mg) vs Warfarin (one-sided 97.5%) was compared with this noninferiority margin for the testing of non-inferiority|A pre-defined hierarchical testing approach was used. This was the third step in hierarchy.||1.29|0.84|0.0047
72408983|NCT00048724|144326455|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.564||||0.007||95.0|1.13|2.166|||Cox Proportional Hazards Model|Age (\<= 50 years, \>50 years) and participation in a prior study (yes, no) were stratification factors.|Hazard ratio represents results of untreated control relative to treatment.|The secondary hypothesis is that 0.5 ug/kg subcutaneous once weekly PegIntron as maintenance therapy is efficacious, when compared to no treatment, in the prevention of disease progression in adult subjects with compensated cirrhosis (Metavir F4), secondary to Chronic Hepatitis C, who have failed to respond to therapy with any α interferon plus ribavirin.||2.166|1.130|0.0070
72626697|NCT02164864|144782262|OTHER||Hazard Ratio (HR)|1.13||||0.3002|TWO_SIDED|95.0|0.9|1.43||Wald 2-sided p-value from (stratified) Cox proportional hazards model|Regression, Cox|The Cox proportional hazard model is stratified by age, non-elderly vs elderly \[\<70 or \>=70 in Japan and \<80 or \>=80 years old elsewhere\].|Hazard Ratio (HR) and Wald confidence intervals are derived from a Cox proportional-hazard model|||1.43|0.90|0.3002
72626698|NCT02164864|144782262|OTHER||Hazard Ratio (HR)|0.89||||0.4432|TWO_SIDED|95.0|0.67|1.19||Wald 2-sided p-value from (unstratified) Cox proportional hazards model|Regression, Cox|unstratified Cox proportional hazards model was used and elderly patients outside the USA were excluded|Hazard Ratio (HR) and Wald confidence intervals are derived from a Cox proportional-hazard model|||1.19|0.67|0.4432
72626699|NCT04358406|144782265|SUPERIORITY||||||>|0.05|||||||Cochran-Mantel-Haenszel|||||||>0.05
72626700|NCT04358406|144782265|SUPERIORITY||||||>|0.1|||||||Chi-squared|||||||>0.1
72626701|NCT01668004|144782287|SUPERIORITY_OR_OTHER|||||||1|||||||McNemar|||Treatment comparison of uveitis occurrence rate assessed 1 year before initial anti-TNF/GLM treatment and 1 year after start of GLM treatment. Number of subjects included in analysis: N=93.||||1.0000
72626702|NCT01668004|144782288|SUPERIORITY_OR_OTHER||Treatment Ratio|4.5|||<|0.0001|TWO_SIDED|95.0|3.86|5.25|||Generalized estimating equation|||Treatment difference (expressed as ratio) in uveitis incidence rate assessed 1 year before initial anti-TNF/GLM treatment and 1 year after start of GLM treatment. Number of subjects included in analysis: N=92.||5.25|3.86|<0.0001
72536723|NCT02080273|144603838|OTHER|||||||0.001||||||1 factor ANCOVA to determine difference between groups with baseline as covariate. The F statistic is used to determine significance. If significance is found then a Tukey's multiple comparison is done.|ANCOVA|||The null hypothesis states that there is no difference between groups. ANCOVA adjusting for baseline.||||0.001
72536724|NCT02080273|144603839|OTHER|||||||0.001||||||1 factor ANCOVA to determine difference between groups with baseline as covariate. The F statistic is used to determine significance. If significance is found then a Tukey's multiple comparison is done.|ANCOVA|||The null hypothesis states that there is no difference between groups. ANCOVA adjusting for baseline.||||0.001
72536725|NCT00956813|144603840|SUPERIORITY_OR_OTHER|||||||0.29|||||||t-test, 2 sided|||||||0.29
72536726|NCT00956813|144603842|SUPERIORITY_OR_OTHER|||||||0.93|||||||Kruskal-Wallis|||||||0.93
72536727|NCT00956813|144603843|SUPERIORITY_OR_OTHER|||||||0.19|||||||Kruskal-Wallis|||Testing the change in score from baseline to treatment completion for vasomotor-related questions in the MENQOL form.||||0.19
72408984|NCT00844545|144326456|SUPERIORITY_OR_OTHER||LS mean change from baseline|65.18|||<|0.0001|TWO_SIDED|95.0|37.01|93.36|||ANOVA|Change from baseline were analyzed using a repeated measurement ANOVA model with time and baseline as fixed effects and subject as a random effect.||With at least 12 patients enrolled and assuming a null hypothesis of no post-dose change from baseline in mean platelet count, the study had approximately 88% power to detect as statistically significant an effect size (mean change from baseline/standard deviation) of at least 1 when using a one sample t-test with a two-sided α=0.05. All analyses were based on the pooled data from the two protocols: C08-002A (adult) and C08-002B (adolescent), a similar protocol, for patients \<18 years with aHUS.||93.36|37.01|<0.0001
72408985|NCT00844545|144326457|SUPERIORITY_OR_OTHER||Percent of platelet count normalization|82.0|||||TWO_SIDED|95.0|57.0|96.0||||||All analyses were based on the pooled data from the two protocols: protocol C08-002A for adult patients with aHUS and protocol C08-002B, a similar protocol, for patients \< 18 years of age for adolescent patients with aHUS.||96|57|
72536728|NCT00956813|144603843|SUPERIORITY_OR_OTHER|||||||0.78|||||||Kruskal-Wallis|||Testing the change in score from baseline to treatment completion for Psychosocial-related questions in the MENQOL form.||||0.78
72536729|NCT00956813|144603843|SUPERIORITY_OR_OTHER|||||||0.238|||||||Kruskal-Wallis|||Testing the change in score from baseline to treatment completion for Physical-related questions in the MENQOL form.||||0.238
72536730|NCT00956813|144603843|SUPERIORITY_OR_OTHER|||||||0.497|||||||Kruskal-Wallis|||Testing the change in score from baseline to treatment completion for Sexually-related questions in the MENQOL form.||||0.497
72536731|NCT00956813|144603844|SUPERIORITY_OR_OTHER|||||||0.089|||||||Kruskal-Wallis|||||||0.089
72536732|NCT03252015|144603994|SUPERIORITY||Mean Difference (Final Values)|-0.182|||||TWO_SIDED|95.0|-0.412|0.049||||||Day 7||0.049|-0.412|
72536733|NCT03252015|144603994|SUPERIORITY||Mean Difference (Final Values)|0.071|||||TWO_SIDED|95.0|-0.081|0.224||||||Day 7||0.224|-0.081|
72536734|NCT03252015|144603994|SUPERIORITY||Mean Difference (Final Values)|0.0|||||TWO_SIDED|95.0|0.0|0.0||||||Day 21||0.000|0.000|
72536735|NCT03252015|144603994|SUPERIORITY||Mean Difference (Final Values)|0.0|||||TWO_SIDED|95.0|0.0|0.0||||||Day 21||0.000|0.000|
72536736|NCT03252015|144603995|SUPERIORITY||Mean Difference (Final Values)|-0.145|||||TWO_SIDED|95.0|-0.34|0.05||||||Day 7||0.050|-0.340|
72536737|NCT03252015|144603995|SUPERIORITY||Mean Difference (Final Values)|0.071|||||TWO_SIDED|95.0|-0.081|0.224||||||||0.224|-0.081|
72626703|NCT02448381|144782296|SUPERIORITY|||||||0.04|||||||Regression, Logistic|||||||0.04
72408986|NCT00844545|144326458|SUPERIORITY_OR_OTHER||Percent of hematologic normalization|76.0|||||TWO_SIDED|95.0|50.0|93.0||||||All analyses were based on the pooled data from the two protocols: protocol C08-002A for adult patients with aHUS and protocol C08-002B, a similar protocol, for patients \< 18 years of age for adolescent patients with aHUS.||93|50|
72408987|NCT00844545|144326459|SUPERIORITY_OR_OTHER||Percent of complete TMA response|65.0|||||TWO_SIDED|95.0|38.0|86.0||||||All analyses were based on the pooled data from the two protocols: protocol C08-002A for adult patients with aHUS and protocol C08-002B, a similar protocol, for patients \< 18 years of age for adolescent patients with aHUS.||86|38|
72536738|NCT03252015|144603995|SUPERIORITY||Mean Difference (Final Values)|0.071|||||TWO_SIDED|95.0|-0.151|0.294||||||Day 21||0.294|-0.151|
72536739|NCT03252015|144603995|SUPERIORITY||Mean Difference (Final Values)|0.0|||||TWO_SIDED|95.0|0.0|0.0||||||Day 21||0.000|0.000|
72536740|NCT00903409|144604021|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The difference between Non-switchers and Switchers in the percent change in non-HDL-C level from the end of the OM6 double-blind study (average of Weeks 6 and 8 for the statistical analysis) to 4 months of OM6X open-label treatment (Month 4).|Kruskal-Wallis|||||||<0.001
72536741|NCT01516684|144604029|OTHER|||||||0.036|||||||T-test and chi-square|||Raw mean total dose administered and raw percentage of times additional propofol was administered will be presented by sedation group treating each event (sedation with lumbar puncture) as the unit. T-test and chi-square tests will be performed as appropriate for the outcome. GEE methods will be used when analyzing the percentage of times additional propofol was administered. Mixed model regression methods will be used when analyzing the total dose administered.||||0.036
72536742|NCT01516684|144604031|OTHER|Marginal mixed model (GEE type)||||||0.094|||||||Mixed Models Analysis|||||||0.094
72536743|NCT01516684|144604032|OTHER|||||||0.382|||||||Chi-squared|||||||0.382
72536744|NCT01516684|144604033|OTHER|Marginal mixed model (GEE type)||||||0.426|||||||Mixed Models Analysis|||||||0.426
72536745|NCT02262507|144604100|OTHER||||||<|0.05|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.05
72536746|NCT00975000|144604131|SUPERIORITY_OR_OTHER||Chi-Square test statistic|66.437|||<|0.001|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test stratified by baseline corrected total serum calcium level (≤ 11.2 mg/dL and \> 11.2 mg/dL)||The primary endpoint was tested at a significance level of 0.05.||||<0.001
72536747|NCT00975000|144604131|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|91.41|||||TWO_SIDED|95.0|18.76|445.41|||||Odds ratio of Cinacalcet/Placebo|||445.41|18.76|
72536748|NCT00975000|144604131|SUPERIORITY_OR_OTHER||Difference|75.44|||||TWO_SIDED|95.0|63.83|87.05|||||Difference = Cinacalcet-Placebo|||87.05|63.83|
72536749|NCT00975000|144604132|SUPERIORITY_OR_OTHER||Difference|1.41||||0.266|TWO_SIDED|95.0|-1.1|3.93|||ANCOVA|Analysis of covariance (ANCOVA) with Baseline corrected total serum calcium group as a covariate.|Least square estimate for the difference in the percent change in BMD between the 2 treatment groups (cinacalcet - placebo)|||3.93|-1.10|0.266
72536750|NCT00975000|144604133|SUPERIORITY_OR_OTHER||Difference|0.45|||<|0.001|TWO_SIDED|95.0|0.26|0.64|||ANCOVA|Analysis of covariance (ANCOVA) with Baseline corrected total serum calcium group as a covariate.|Least square estimate for the difference in the absolute change in mean serum phosphorus between the 2 treatment groups (cinacalcet - placebo)|||0.64|0.26|<0.001
72536751|NCT00975000|144604134|SUPERIORITY_OR_OTHER||Difference|-0.4||||0.842|TWO_SIDED|95.0|-4.37|3.57|||ANCOVA|ANCOVA with Baseline corrected total serum calcium group as a covariate.|Least square estimate for the difference in the absolute change in mean eGFR between the 2 treatment groups (cinacalcet - placebo)|||3.57|-4.37|0.842
72626704|NCT02448381|144782297|SUPERIORITY||||||<|0.0001|||||||Regression, Logistic|||||||<0.0001
72626705|NCT02448381|144782298|SUPERIORITY|||||||0.046|||||||McNemar|||||||0.046
72626706|NCT02448381|144782299|SUPERIORITY||||||=|0.0009|||||||Fisher Exact|||||||=0.0009
72626707|NCT02448381|144782300|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||||||<0.0001
72626708|NCT03229538|144782301|OTHER||Adjusted Odds Ratio|0.86||||0.14|TWO_SIDED|95.0|0.71|1.05|||Regression, Logistic|||||1.05|0.71|0.14
72536752|NCT00975000|144604135|SUPERIORITY_OR_OTHER||Difference|-1.39|||<|0.001|TWO_SIDED|95.0|-1.62|-1.16|||ANCOVA|ANCOVA with Baseline corrected total serum calcium group as a covariate.|Least square estimate for the difference in the absolute change in corrected total calcium between the 2 treatment groups (cinacalcet - placebo)|||-1.16|-1.62|<0.001
72536753|NCT00975000|144604136|SUPERIORITY_OR_OTHER||Difference|-117.21||||0.002|TWO_SIDED|95.0|-189.88|-44.55|||ANCOVA|ANCOVA with Baseline corrected total serum calcium group as a covariate.|Least square estimate for the difference in the absolute change in iPTH between the 2 treatment groups (cinacalcet - placebo)|||-44.55|-189.88|0.002
72536754|NCT00975000|144604137|SUPERIORITY_OR_OTHER||Difference|-1.42||||0.846|TWO_SIDED|95.0|-15.91|13.06|||ANCOVA|ANCOVA with Baseline corrected total serum calcium group as a covariate.|Least square estimate for the difference in the absolute change in urine phosphorus between the 2 treatment groups (cinacalcet - placebo)|||13.06|-15.91|0.846
72536755|NCT00902486|144604142|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.17||||0.0619|TWO_SIDED|95.0|0.77|6.15|||Cochran-Armitage trend test||LOGISTIC regression model for odds ratio estimates : LOGIT(Response 0/1) = Treatment + Biologics|The prespecified primary analysis for ACR 20 was the Cochran-Armitage trend test looking for a dose-response relationship. The treatment effect was also assessed using a logistic regression model including background therapy (more than 8 weeks of biologics or not) and treatment.||6.15|0.77|0.0619
72536756|NCT00902486|144604142|OTHER|||||||0.1978|||||||Fisher Exact|||Sensitivity analysis for pairwise comparisons of 4 mg QD versus placebo.||||0.1978
72536757|NCT00902486|144604142|OTHER|||||||0.0437|||||||Fisher Exact|||Sensitivity analysis for pairwise comparisons of 7 mg QD versus placebo.||||0.0437
72536758|NCT00902486|144604142|OTHER|||||||0.1236|||||||Fisher Exact|||Sensitivity analysis for pairwise comparisons of 10 mg QD versus placebo.||||0.1236
72536759|NCT01017731|144604203|SUPERIORITY_OR_OTHER|||||||0.0161||||||The p-value for QTc interval prolongation compared to baseline.|Mixed Models Analysis|||||||0.0161
72536760|NCT01107834|144604229|SUPERIORITY_OR_OTHER|||||||0.27|||||||t-test, 2 sided|||T-test to detect differences between groups||||0.27
72536761|NCT01107834|144604230|SUPERIORITY_OR_OTHER|||||||0.46|||||||t-test, 2 sided|||T-test to detect differences between groups||||0.46
72536762|NCT01107834|144604231|SUPERIORITY_OR_OTHER|||||||0.13|||||||t-test, 2 sided|||T-test to detect differences between groups||||0.13
72536763|NCT01107834|144604232|SUPERIORITY_OR_OTHER|||||||0.59|||||||t-test, 2 sided|||T-test to detect differences between groups||||0.59
72573345|NCT03589768|144673273|SUPERIORITY||Ratio|18.9|||<|0.0001|TWO_SIDED|95.0|10.4|34.2|||t-test, 2 sided|Test compares difference in log values.|Difference in log values back transformed into ratio.|Statistical analysis for 6 months after delivery time point|The ratio is calculated as the GMC of the BOOSTRIX group divided by the GMC of the Td group.|34.2|10.4|<0.0001
72573346|NCT03589768|144673274|SUPERIORITY||Ratio|1.0||||0.837|TWO_SIDED|95.0|0.6|1.5|||t-test, 2 sided|Test compares difference in log values.|Difference in log values back transformed into ratio.|Statistical analysis for pre-vaccination time point|The ratio is calculated as the GMC of the BOOSTRIX group divided by the GMC of the Td group.|1.5|0.6|0.8370
72536764|NCT01107834|144604233|SUPERIORITY_OR_OTHER|||||||0.09|||||||t-test, 2 sided|||T-test to detect differences between groups||||0.09
72536765|NCT01107834|144604234|SUPERIORITY_OR_OTHER|||||||0.03|||||||t-test, 2 sided|||T-test to detect differences between groups||||0.03
72536766|NCT02411110|144604251|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.34||||0.505|||||||ANCOVA|Baseline value as a covariate; treatment group and stratification (age: \< 40 or ≥ 40 years and baseline bladder pain NRS: ≤ 6 or \> 6) as factors.|LiRIS® - Placebo|||||0.505
72536767|NCT02871921|144604263|EQUIVALENCE|A linear regression model was run with the outcome being the MoCA score at Month 6, controlling for the baseline MoCA score. The coefficient of the treatment indicator (1: experimental group, 0: control group) is our main interest. The significant coefficient means that treatment and control groups differ in the outcome score at Month 6, controlling for the baseline score.|Mean Difference (Final Values)|0.14|STANDARD_ERROR_OF_MEAN|0.86||0.87|TWO_SIDED||||||Regression, Linear|||Outcome: MoCA at Month 6 Among participants with normal cognition||||0.87
72536768|NCT02871921|144604263|EQUIVALENCE|A linear regression model was run with the outcome being the MoCA score at Month 6, controlling for the baseline MoCA score. The coefficient of the treatment indicator (1: experimental group, 0: control group) is our main interest. The significant coefficient means that treatment and control groups differ in the outcome score at Month 6, controlling for the baseline score.|Mean Difference (Final Values)|1.75|STANDARD_ERROR_OF_MEAN|0.76||0.03|TWO_SIDED||||||Regression, Linear|||Outcome: MoCA at Month 6 Among MCI||||.03
72536769|NCT02871921|144604264|EQUIVALENCE|A linear regression model was run with the outcome being the Category Fluency test score at Month 6, controlling for tits baseline score. The coefficient of the treatment indicator (1: experimental group, 0: control group) is our main interest. The significant coefficient means that treatment and control groups differ in the outcome score at Month 6, controlling for the baseline score and a COVID-19 pandemic period indicator (0: pre-COVID-19 pandemic, 1: during COVID-19 pandemic period).|Mean Difference (Final Values)|2.56|STANDARD_ERROR_OF_MEAN|1.19||0.03|TWO_SIDED||||||Regression, Linear|||Outcome: Category fluency animals Among participants with normal cognition||||0.03
72536770|NCT02871921|144604264|OTHER|A linear regression model was run with the outcome being the Category Fluency test score at Month 6, controlling for tits baseline score. The coefficient of the treatment indicator (1: experimental group, 0: control group) is our main interest. The significant coefficient means that treatment and control groups differ in the outcome score at Month 6, controlling for the baseline score and a COVID-19 pandemic period indicator (0: pre-COVID-19 pandemic, 1: during COVID-19 pandemic period).|Mean Difference (Final Values)|0.69|STANDARD_ERROR_OF_MEAN|0.93||0.46|TWO_SIDED||||||Regression, Linear|||Outcome: Category Fluency (Animals) at Month 6 Among MCI participants||||0.46
72408988|NCT00844545|144326460|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.78|||<|0.0001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||All analyses were based on the pooled data from the two protocols: protocol C08-002A for adult patients with aHUS and protocol C08-002B, a similar protocol, for patients \< 18 years of age for adolescent patients with aHUS.||||<0.0001
72536771|NCT02871921|144604265|EQUIVALENCE|A linear regression model was run with the outcome being the Craft Stroy Immediate Recall score at Month 6, controlling for its baseline score. The coefficient of the treatment indicator (1: experimental group, 0: control group) is our main interest. The significant coefficient means that treatment and control groups differ in the outcome score at Month 6, controlling for the baseline score and a COVID-19 pandemic period indicator (0: pre-COVID-19 pandemic, 1: during COVID-19 pandemic period).|Mean Difference (Final Values)|-0.63|STANDARD_ERROR_OF_MEAN|0.82||0.45|TWO_SIDED||||||Regression, Linear|||Outcome: Craft Stroy Immediate Recall (paraphrase scoring) Among participants with normal cognition||||0.45
72536772|NCT02871921|144604265|EQUIVALENCE|A linear regression model was run with the outcome being the Craft Story score at Month 6, controlling for tits baseline score. The coefficient of the treatment indicator (1: experimental group, 0: control group) is our main interest. The significant coefficient means that treatment and control groups differ in the outcome score at Month 6, controlling for the baseline score and a COVID-19 pandemic period indicator (0: pre-COVID-19 pandemic, 1: during COVID-19 pandemic period).|Mean Difference (Final Values)|-0.66|STANDARD_ERROR_OF_MEAN|0.8||0.41|TWO_SIDED||||||Regression, Linear|||Outcome: Craft Story Immediate Recall (paraphrase) Among MCI||||0.41
72536773|NCT02871921|144604266|EQUIVALENCE|A linear regression model was run with the outcome being the Craft Story test score at Month 6, controlling for tits baseline score. The coefficient of the treatment indicator (1: experimental group, 0: control group) is our main interest. The significant coefficient means that treatment and control groups differ in the outcome score at Month 6, controlling for the baseline score and a COVID-19 pandemic period indicator (0: pre-COVID-19 pandemic, 1: during COVID-19 pandemic period).|Median Difference (Final Values)|-0.26|STANDARD_ERROR_OF_MEAN|0.77||0.74|TWO_SIDED||||||Regression, Linear|||Outcome: Craft Story Delayed Recall) (Paraphrase scoring) Among participants with normal cognition||||0.74
72536774|NCT02871921|144604266|EQUIVALENCE|A linear regression model was run with the outcome being the Craft Story test score at Month 6, controlling for tits baseline score. The coefficient of the treatment indicator (1: experimental group, 0: control group) is our main interest. The significant coefficient means that treatment and control groups differ in the outcome score at Month 6, controlling for the baseline score and a COVID-19 pandemic period indicator (0: pre-COVID-19 pandemic, 1: during COVID-19 pandemic period).|Median Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.79||0.9|TWO_SIDED||||||Regression, Linear|||Outcome: Craft Story Delayed Recall (Paraphrase scoring) Among MCI||||0.90
72536775|NCT01803464|144604273|OTHER||Cohen's d|0.59|||||TWO_SIDED||||||||Cohen's d was calculated. The % change of the Botox plus low-magnitude vibration group minus the % change of the cerebral palsy control group was the numerator. The pooled Standard Deviation (SD) of the % change for the 2 groups was the denominator.|||||
72536776|NCT01803464|144604273|OTHER||Cohen's d|0.13|||||TWO_SIDED||||||||Cohen's d was calculated. The % change of the Botox group minus the % change of the cerebral palsy control group was the numerator. The pooled SD of the % change for the 2 groups was the denominator.|||||
72536777|NCT01803464|144604273|OTHER||Cohen's d|0.51|||||TWO_SIDED||||||||Cohen's d was calculated. The % change of the typically developing control group group minus the % change of the cerebral palsy control group was the numerator. The pooled SD of the % change for the 2 groups was the denominator.|||||
72536778|NCT01803464|144604274|OTHER||Cohen's d|0.45|||||TWO_SIDED||||||||Cohen's d was calculated. The % change of the Botox plus low-magnitude vibration group minus the % change of the cerebral palsy control group was the numerator. The pooled SD of the % change for the 2 groups was the denominator|||||
72536779|NCT01803464|144604274|OTHER||Cohen's d|0.57|||||TWO_SIDED||||||||Cohen's d was calculated. The % change of the Botox group minus the % change of the cerebral palsy control group was the numerator. The pooled SD of the % change for the 2 groups was the denominator.|||||
72536780|NCT01803464|144604274|OTHER||Cohen's d|0.13|||||TWO_SIDED||||||||Cohen's d was calculated. The % change of the typically developing group minus the % change of the cerebral palsy control group was the numerator. The pooled SD of the % change for the 2 groups was the denominator|||||
72536781|NCT01803464|144604275|OTHER||Cohen's d|1.2|||||TWO_SIDED||||||||Cohen's d was calculated. The % change of the Botox plus low-magnitude vibration group minus the % change of the cerebral palsy control group was the numerator. The pooled SD of the % change for the 2 groups was the denominator.|||||
72536782|NCT01803464|144604275|OTHER||Cohen's d|0.33|||||TWO_SIDED||||||||Cohen's d was calculated. The % change of the Botox group minus the % change of the cerebral palsy control group was the numerator. The pooled SD of the % change for the 2 groups was the denominator.|||||
72536783|NCT01803464|144604275|OTHER||Cohen's d|0.33|||||TWO_SIDED||||||||Cohen's d was calculated. The % change of the typically developing control group minus the % change of the cerebral palsy control group was the numerator. The pooled SD of the % change for the 2 groups was the denominator.|||||
72536784|NCT02424851|144604276|OTHER|||||||0.006|||||||Fisher Exact|||||||0.006
72536785|NCT02424851|144604277|OTHER|||||||0.02|||||||Fisher Exact|||||||0.02
72536786|NCT02424851|144604278|OTHER||||||=|0.48|||||||Fisher Exact|||Statistical analysis of SAEs.||||=0.48
72536787|NCT02424851|144604278|OTHER||||||=|0.25|||||||Fisher Exact|||Statistical analysis of AEs||||=0.25
72536788|NCT02424851|144604279|OTHER||||||=|0.31|||||||Log Rank|||||||= 0.31
72536789|NCT02424851|144604280|OTHER||||||=|0.45|||||||Fisher Exact|||||||=0.45
72536790|NCT02424851|144604281|OTHER|||||||0.33|||||||t-test, 1 sided|||||||0.33
72573347|NCT03589768|144673274|SUPERIORITY||Ratio|0.6|||<|0.0001|TWO_SIDED|95.0|0.5|0.8|||t-test, 2 sided|Test compares difference in log values.|Difference in log values back transformed into ratio.|Statistical analysis for one month after vaccination time point|The ratio is calculated as the GMC of the BOOSTRIX group divided by the GMC of the Td group.|0.8|0.5|<0.0001
72573348|NCT03589768|144673274|SUPERIORITY||Ratio|0.7||||0.005|TWO_SIDED|95.0|0.6|0.9|||t-test, 2 sided|Test compares difference in log values.|Difference in log values back transformed into ratio.|Statistical analysis for delivery time point|The ratio is calculated as the GMC of the BOOSTRIX group divided by the GMC of the Td group.|0.9|0.6|0.0050
72573349|NCT03589768|144673274|SUPERIORITY||Ratio|0.8||||0.0689|TWO_SIDED|95.0|0.6|1.0|||t-test, 2 sided|Test compares difference in log values.|Difference in log values back transformed into ratio.|Statistical analysis for 6 months after delivery time point|The ratio is calculated as the GMC of the BOOSTRIX group divided by the GMC of the Td group.|1.0|0.6|0.0689
72408989|NCT00844545|144326461|SUPERIORITY_OR_OTHER||LS mean change from baseline|111.62|||<|0.0001|TWO_SIDED|95.0|98.12|125.13|||ANOVA|Change from baseline were analyzed using a repeated measurement ANOVA model with time and baseline as fixed effects and subject as a random effect.||All analyses were based on the pooled data from the two protocols: protocol C08-002A for adult patients with aHUS and protocol C08-002B, a similar protocol, for patients \< 18 years of age for adolescent patients with aHUS.||125.13|98.12|<0.0001
72408990|NCT00844545|144326462|SUPERIORITY_OR_OTHER||Percent of platelet count normalization|88.0|||||TWO_SIDED|95.0|64.0|99.0||||||All analyses were based on the pooled data from the two protocols: protocol C08-002A for adult patients with aHUS and protocol C08-002B, a similar protocol, for patients \< 18 years of age for adolescent patients with aHUS.||99|64|
72408991|NCT00844545|144326463|SUPERIORITY_OR_OTHER||Percent of hematologic normalization|88.0|||||TWO_SIDED|95.0|64.0|99.0||||||All analyses were based on the pooled data from the two protocols: protocol C08-002A for adult patients with aHUS and protocol C08-002B, a similar protocol, for patients \< 18 years of age for adolescent patients with aHUS.||99|64|
72408992|NCT00844545|144326464|SUPERIORITY_OR_OTHER||Percent of complete TMA response|76.0|||||TWO_SIDED|95.0|50.0|93.0||||||All analyses were based on the pooled data from the two protocols: protocol C08-002A for adult patients with aHUS and protocol C08-002B, a similar protocol, for patients \< 18 years of age for adolescent patients with aHUS.||93|50|
72408993|NCT00844545|144326465|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.78|||<|0.0001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||All analyses were based on the pooled data from the two protocols: protocol C08-002A for adult patients with aHUS and protocol C08-002B, a similar protocol, for patients \< 18 years of age for adolescent patients with aHUS.||||<0.0001
72408994|NCT02595684|144326482|SUPERIORITY|||||||0.327|||||||Wilcoxon (Mann-Whitney)|||||||0.327
72536791|NCT01360021|144604290|SUPERIORITY_OR_OTHER||Estimated Geometic Mean Ratio|1.1||||0.001|TWO_SIDED|95.0|1.06|1.14|||ANCOVA|ANCOVA model on the log transformed outcome variable with treatment and country as factor, and log transformed baseline FEV1 (pre-dose) as covariate.|Symbicort AC pMDI 2x160/4.5 µg bid vs Budesonide AC pMDI 2x160 µg bid|The comparison of Symbicort AC pMDI 2x160/4.5 µg bid with budesonide AC pMDI 2x160 µg bid for post dose FEV1||1.14|1.06|0.001
72573350|NCT03589768|144673275|SUPERIORITY||Ratio|1.0||||0.8361|TWO_SIDED|95.0|0.7|1.6|||t-test, 2 sided|Test compares difference in log values.|Difference in log values back transformed into ratio.|Statistical analysis for pre-vaccination time point|The ratio is calculated as the GMC of the BOOSTRIX group divided by the GMC of the Td group.|1.6|0.7|0.8361
72408995|NCT02595684|144326482|SUPERIORITY|||||||0.635|||||||Wilcoxon (Mann-Whitney)|||||||0.635
72408996|NCT02595684|144326483|SUPERIORITY|||||||0.38|||||||Wilcoxon (Mann-Whitney)|||||||0.380
72408997|NCT02595684|144326483|SUPERIORITY|||||||0.441|||||||Wilcoxon (Mann-Whitney)|||||||0.441
72408998|NCT02595684|144326484|SUPERIORITY|||||||515|||||||Wilcoxon (Mann-Whitney)|||||||0515
72408999|NCT02595684|144326484|SUPERIORITY|||||||0.953|||||||Wilcoxon (Mann-Whitney)|||||||0.953
72409000|NCT02595684|144326485|SUPERIORITY|||||||0.314|||||||Wilcoxon (Mann-Whitney)|||||||0.314
72409001|NCT02595684|144326485|SUPERIORITY|||||||0.594|||||||Wilcoxon (Mann-Whitney)|||||||0.594
72409002|NCT02595684|144326486|SUPERIORITY|||||||0.767|||||||Wilcoxon (Mann-Whitney)|||||||0.767
72409003|NCT02595684|144326486|SUPERIORITY|||||||0.779|||||||Wilcoxon (Mann-Whitney)|||||||0.779
72409004|NCT02595684|144326487|SUPERIORITY|||||||0.859|||||||Wilcoxon (Mann-Whitney)|||||||0.859
72409005|NCT02595684|144326487|SUPERIORITY|||||||0.767|||||||Wilcoxon (Mann-Whitney)|||||||0.767
72409006|NCT02595684|144326488|SUPERIORITY|||||||0.374|||||||Wilcoxon (Mann-Whitney)|||||||0.374
72409007|NCT02595684|144326488|SUPERIORITY|||||||0.953|||||||Wilcoxon (Mann-Whitney)|||||||0.953
72409008|NCT02595684|144326489|SUPERIORITY|||||||0.594|||||||Wilcoxon (Mann-Whitney)|||||||0.594
72573351|NCT03589768|144673275|SUPERIORITY||Ratio|0.9||||0.5136|TWO_SIDED|95.0|0.6|1.3|||t-test, 2 sided|Test compares difference in log values.|Difference in log values back transformed into ratio.|Statistical analysis for one month after vaccination time point|The ratio is calculated as the GMC of the BOOSTRIX group divided by the GMC of the Td group.|1.3|0.6|0.5136
72409009|NCT02595684|144326489|SUPERIORITY|||||||0.085|||||||Wilcoxon (Mann-Whitney)|||||||0.085
72409010|NCT02595684|144326490|SUPERIORITY|||||||0.594|||||||Wilcoxon (Mann-Whitney)|||||||0.594
72409011|NCT02595684|144326490|SUPERIORITY|||||||0.086|||||||Wilcoxon (Mann-Whitney)|||||||0.086
72409012|NCT02595684|144326491|SUPERIORITY|||||||0.285|||||||Wilcoxon (Mann-Whitney)|||||||0.285
72409013|NCT02595684|144326491|SUPERIORITY|||||||0.854|||||||Wilcoxon (Mann-Whitney)|||||||0.854
72409014|NCT02595684|144326492|SUPERIORITY|||||||0.374|||||||Wilcoxon (Mann-Whitney)|||||||0.374
72409015|NCT02595684|144326492|SUPERIORITY|||||||0.263|||||||Wilcoxon (Mann-Whitney)|||||||0.263
72409016|NCT02595684|144326493|SUPERIORITY|||||||0.859|||||||Wilcoxon (Mann-Whitney)|||||||0.859
72409017|NCT02595684|144326493|SUPERIORITY|||||||0.374|||||||Wilcoxon (Mann-Whitney)|||||||0.374
72409018|NCT02595684|144326494|SUPERIORITY|||||||0.722|||||||Wilcoxon (Mann-Whitney)|||||||0.722
72409019|NCT02595684|144326494|SUPERIORITY|||||||0.953|||||||Wilcoxon (Mann-Whitney)|||||||0.953
72409020|NCT02595684|144326495|SUPERIORITY|||||||0.26|||||||Wilcoxon (Mann-Whitney)|||||||0.260
72409021|NCT02595684|144326495|SUPERIORITY|||||||0.314|||||||Wilcoxon (Mann-Whitney)|||||||0.314
72409022|NCT02595684|144326496|SUPERIORITY|||||||0.058|||||||Wilcoxon (Mann-Whitney)|||||||0.058
72409023|NCT02595684|144326496|SUPERIORITY|||||||0.952|||||||Wilcoxon (Mann-Whitney)|||||||0.952
72409024|NCT02595684|144326497|SUPERIORITY|||||||0.128|||||||Wilcoxon (Mann-Whitney)|||||||0.128
72409025|NCT02595684|144326497|SUPERIORITY|||||||0.108|||||||Wilcoxon (Mann-Whitney)|||||||0.108
72409026|NCT02595684|144326498|SUPERIORITY|||||||0.092|||||||Wilcoxon (Mann-Whitney)|||||||0.092
72409027|NCT02595684|144326498|SUPERIORITY|||||||0.374|||||||Wilcoxon (Mann-Whitney)|||||||0.374
72409028|NCT02809976|144326507|OTHER|single group/descriptive analysis||||||0.02|||||||paired t-test|||||||0.02
72626709|NCT03229538|144782301|OTHER||Percent Difference|-0.8|||||TWO_SIDED|95.0|-2.6|0.9|||||Difference = Methylprednisolone - Placebo|Rank = 97||0.9|-2.6|
72626710|NCT03229538|144782301|OTHER||Percent Difference|-1.5|||||TWO_SIDED|95.0|-3.5|0.5|||||Difference = Methylprednisolone - Placebo|Rank \> or = 96||0.5|-3.5|
72626711|NCT03229538|144782301|OTHER||Percent Difference|-2.2|||||TWO_SIDED|95.0|-4.4|0.1|||||Difference = Methylprednisolone - Placebo|Rank \> or = 95||0.1|-4.4|
72536792|NCT01360021|144604290|NON_INFERIORITY_OR_EQUIVALENCE|Assuming a standard deviation of 0.2 (for pre dose FEV1) on the log-scale and 60 patients/arm, the width of the confidence interval will extend 0.072 from the point estimate on the log-scale. The lower and upper limits of the CI for the ratio of effects will thus be obtained by multiplying the estimated ratio by 0.931 and 1.075, respectively.|Estimated Geometric Mean Ratio|1.01|||||TWO_SIDED|95.0|0.97|1.05|||ANCOVA|ANCOVA model on the log transformed outcome variable with treatment and country as factor, and log transformed baseline FEV1 (pre-dose) as covariate.|The comparisons was used to assess therapeutic equivalence of Symbicort AC pMDI and Symbicort BA MDI. Assay sensitivity was demonstrated before proceeding to assess therapeutic equivalence of the 2 Symbicort products.|The comparisons of Symbicort BA MDI 2x160/4.5 µg bid with Symbicort AC pMDI 2x160/4.5 µg bid for post dose FEV1.||1.05|0.97|
72536793|NCT01360021|144604291|NON_INFERIORITY_OR_EQUIVALENCE|Assuming a standard deviation of 0.2 (for pre dose FEV1) on the log-scale and 60 patients/arm, the width of the confidence interval will extend 0.072 from the point estimate on the log-scale. The lower and upper limits of the CI for the ratio of effects will thus be obtained by multiplying the estimated ratio by 0.931 and 1.075, respectively.|Estimated Geometric Mean Ratio|1.03|||||TWO_SIDED|95.0|0.99|1.08|||ANCOVA|ANCOVA model on the log transformed outcome variable with treatment and country as factor, and log transformed baseline FEV1 (pre-dose) as covariate.|The comparisons was used to assess therapeutic equivalence of Symbicort AC pMDI and Symbicort BA MDI. Assay sensitivity was demonstrated before proceeding to assess therapeutic equivalence of the 2 Symbicort products.|The comparisons of Symbicort BA MDI 2x160/4.5 µg bid with Symbicort AC pMDI 2x160/4.5 µg bid, for pre-dose FEV1.||1.08|0.99|
72536794|NCT01360021|144604292|NON_INFERIORITY_OR_EQUIVALENCE|No adjustment were be made for multiplicity for these supportive variables and nominal p-values were reported.|Mean Difference (Net)|1.49|STANDARD_ERROR_OF_MEAN|6.75||0.825|TWO_SIDED|95.0|-11.81|14.8|||ANCOVA|ANCOVA model includes treatment and country as a factor and baseline value as covariate.|Secondary efficacy variables were analyzed as continuous data, comparing mean changes from baseline to the average of the double-blind treatment period between treatments. No adjustment were made for multiplicity and nominal p-values were reported.|Morning peak expiratory flow (mPEF): Comparing mean changes from baseline to the average of the double-blind treatment period between Symbicort BA MDI 2x160/4.5 μg bid and Symbicort AC pMDI 2x160/4.5 µg bid||14.80|-11.81|0.825
72536795|NCT01360021|144604292|SUPERIORITY_OR_OTHER||Mean Difference (Net)|33.52|STANDARD_ERROR_OF_MEAN|6.8||0.001|TWO_SIDED|95.0|20.11|46.93|||ANCOVA|ANCOVA model includes treatment and country as a factor and baseline value as covariate.|Secondary efficacy variables were analyzed as continuous data, comparing mean changes from baseline to the average of the double-blind treatment period between treatments. No adjustment were made for multiplicity and nominal p-values were reported.|Morning peak expiratory flow (mPEF): Comparing mean changes from baseline to the average of the double-blind treatment period between Symbicort AC pMDI 2x160/4.5 µg bid minus Budesonide AC pMDI 2x160 µg bid||46.93|20.11|0.001
72536796|NCT01360021|144604292|NON_INFERIORITY_OR_EQUIVALENCE|No adjustment were made for multiplicity for these supportive variables and nominal p-values were reported.|Mean Difference (Net)|1.48|STANDARD_ERROR_OF_MEAN|6.15||0.81|TWO_SIDED|95.0|-10.66|13.61|||ANCOVA|ANCOVA model includes treatment and country as a factor and baseline value as covariate.|Secondary efficacy variables were analyzed as continuous data, comparing mean changes from baseline to the average of the double-blind treatment period between treatments. No adjustment were made for multiplicity and nominal p-values were reported.|Evening peak expiratory flow (ePEF): Comparing mean changes from baseline to the average of the double-blind treatment period between Symbicort BA MDI 2x160/4.5 μg bid and Symbicort AC pMDI 2x160/4.5 µg bid.||13.61|-10.66|0.810
72536797|NCT01360021|144604292|SUPERIORITY_OR_OTHER||Mean Difference (Net)|32.25|STANDARD_ERROR_OF_MEAN|6.21||0.001|TWO_SIDED|95.0|20.01|44.49|||ANCOVA|ANCOVA model includes treatment and country as a factor and baseline value as covariate.|Secondary efficacy variables were analyzed as continuous data, comparing mean changes from baseline to the average of the double-blind treatment period between treatments. No adjustment were made for multiplicity and nominal p-values were reported.|Evening peak expiratory flow (ePEF): Comparing mean changes from baseline to the average of the double-blind treatment period between Symbicort AC pMDI 2x160/4.5 µg bid and Budesonide AC pMDI 2x160 µg bid.||44.49|20.01|0.001
72536798|NCT01360021|144604293|NON_INFERIORITY_OR_EQUIVALENCE|No adjustment were made for multiplicity for these supportive variables and nominal p-values were reported.|Mean Difference (Net)|0.13|STANDARD_ERROR_OF_MEAN|0.11||0.272|TWO_SIDED|95.0|-0.1|0.35|||ANCOVA|ANCOVA model includes treatment and country as a factor and baseline value as covariate.||Comparing mean changes from baseline to the average of the double-blind treatment period between Symbicort BA MDI 2x160/4.5 μg bid and Symbicort AC pMDI 2x160/4.5 µg bid.||0.35|-0.10|0.272
72536799|NCT01360021|144604294|NON_INFERIORITY_OR_EQUIVALENCE|No adjustment were made for multiplicity for these supportive variables and nominal p-values were reported.|Mean Difference (Net)|-6.1|STANDARD_ERROR_OF_MEAN|2.69||0.025|TWO_SIDED|95.0|-11.41|-0.79|||ANCOVA|ANCOVA model includes treatment and country as a factor and baseline value as covariate.||Comparing mean changes from baseline to the average of the double-blind treatment period between Symbicort BA MDI 2x160/4.5 μg bid and Symbicort AC pMDI 2x160/4.5 µg bid.||-0.79|-11.41|0.025
72626712|NCT03229538|144782301|OTHER||Percent Difference|-0.8|||||TWO_SIDED|95.0|-4.3|2.7|||||Difference = Methylprednisolone - Placebo|Rank \> or = 94||2.7|-4.3|
72626713|NCT03229538|144782301|OTHER||Percent Difference|-3.8|||||TWO_SIDED|95.0|-7.8|0.2|||||Difference = Methylprednisolone - Placebo|Rank \> or = 93||0.2|-7.8|
72626714|NCT03229538|144782301|OTHER||Percent Difference|-3.4|||||TWO_SIDED|95.0|-7.8|0.9|||||Difference = Methylprednisolone - Placebo|Rank \> or = 92||0.9|-7.8|
72626715|NCT03229538|144782301|OTHER||Percent Difference|-3.1|||||TWO_SIDED|95.0|-7.5|1.3|||||Difference = Methylprednisolone - Placebo|Rank \> or = 91||1.3|-7.5|
72626716|NCT03229538|144782302|SUPERIORITY|It was estimated that 1200 patients (600 per trial group) would provide the trial with more than 90% power to detect superiority of methylprednisolone.|Adjusted Odds Ratio|0.74||||0.428|TWO_SIDED|95.0|0.34|1.57|||Regression, Logistic|||||1.57|0.34|0.428
72409029|NCT04394351|144326524|SUPERIORITY||Odds Ratio (OR)|53.8|||<|0.0001|TWO_SIDED|95.0|7.37|392.82|||Cochran-Mantel-Haenszel|p-value was derived by Cochran-Mantel-Haenszel (CMH) test stratified by baseline weight group.|Odds ratio and corresponding Confidence Interval (CI) are based on CMH test stratified by baseline weight group.|Part A: Dupilumab High Dose versus Part A: Pooled Placebo||392.82|7.37|<0.0001
72536800|NCT01360021|144604295|NON_INFERIORITY_OR_EQUIVALENCE|No adjustment were made for multiplicity for these supportive variables and nominal p-values were reported.|Mean Difference (Net)|0.26|STANDARD_ERROR_OF_MEAN|0.23||0.258|TWO_SIDED|95.0|-0.19|0.71|||ANCOVA|ANCOVA model includes treatment and country as a factor and baseline value as covariate.||Comparing mean changes from baseline to the average of the double-blind treatment period between BAI Symbicort BA MDI 2x160/4.5 μg bid and pMDI Symbicort AC pMDI 2x160/4.5 µg bid.||0.71|-0.19|0.258
72536801|NCT02446496|144604296|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence is established when 90% Confidence Interval falls within 80-125%.|Point estimate percent|95.91|||||TWO_SIDED|90.0|85.67|107.37||||||||107.37|85.67|
72536802|NCT02446496|144604297|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence is established when 90% Confidence Interval falls within 80-125%.|Point estimate percent|102.31|||||TWO_SIDED|90.0|90.46|115.7|||||Comparison of AUC (0-t) between Treatment A and Treatment B|||115.70|90.46|
72536803|NCT02446496|144604297|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence is established when 90% Confidence Interval falls within 80-125%.|Point estimate percent|103.13|||||TWO_SIDED|90.0|91.19|116.62|||||Comparison of AUC(0-infinity) between Treatment A and Treatment B|||116.62|91.19|
72536804|NCT02446496|144604298|SUPERIORITY_OR_OTHER|||||||0.267||95.0|||||Wilcoxon's Signed-Rank Test|Comparison of T-max between Treatment A and Treatment B.||||||0.2670
72536805|NCT03170271|144604314|SUPERIORITY|The null hypothesis was that the exacerbation rate of benralizumab was equal to the exacerbation rate of placebo.|Rate ratio|0.51|||<|0.0001|TWO_SIDED|95.0|0.39|0.65|||Negative binomial|||Comparison of annual exacerbation rates for benralizumab vs placebo (rate ratio). Treatment group, region, number of exacerbations in previous year and maintenance OCS use at baseline were included in the negative binomial model as covariates. The log of each patient's corresponding follow-up time was used as an offset variable in the model to adjust for patients having different follow-up times during which events occurred.||0.65|0.39|<0.0001
72536806|NCT03170271|144604315|SUPERIORITY||LS Mean difference|-8.11|||<|0.0001|TWO_SIDED|95.0|-11.41|-4.82|||Repeated measures analysis||Model: Change from baseline in SGRQ total score = Treatment + baseline SGRQ total score + region + number of exacerbations in previous year + maintenance OCS use at baseline + visit + treatment by visit.|Change from baseline in SGRQ total score at Week 24 was compared between the benralizumab group and placebo group using a restricted maximum likelihood based on a mixed-effect model for repeated measures (MMRM) analysis.||-4.82|-11.41|<0.0001
72536807|NCT03170271|144604316|SUPERIORITY||LS Mean difference|0.16|||<|0.0001|TWO_SIDED|95.0|0.09|0.23|||Repeated measures analysis||Model: Change from baseline in pre-BD FEV1 = Treatment + baseline pre-BD FEV1 + region + number of exacerbations in previous year + maintenance OCS use at baseline + gender + age + visit + treatment by visit.|Change from baseline in pre-BD FEV1 at Week 24 was compared between the benralizumab group and placebo group using a restricted maximum likelihood based on a MMRM analysis.||0.23|0.09|<0.0001
72536808|NCT03170271|144604317|SUPERIORITY||LS Mean difference|-0.46|||<|0.0001|TWO_SIDED|95.0|-0.65|-0.27|||Repeated measures analysis||Model: Change from baseline in ACQ-6 score = Treatment + baseline ACQ-6 score + region + number of exacerbations in previous year + maintenance OCS use at baseline + visit + treatment by visit.|Change from baseline in ACQ-6 score at Week 24 was compared between the benralizumab group and placebo group using a restricted maximum likelihood based on a MMRM analysis.||-0.27|-0.65|<0.0001
72536809|NCT03170271|144604318|SUPERIORITY||Hazard Ratio (HR)|0.52|||<|0.0001|TWO_SIDED|95.0|0.4|0.67|||Regression, Cox||A hazard ratio \< 1 favours benralizumab to be associated with a longer time from randomization to the first exacerbation than placebo.|Comparison of time to first asthma exacerbation for benralizumab vs placebo. Treatment group, region, number of exacerbations in previous year and maintenance OCS use at baseline were included in the Cox proportional hazard model as covariates.||0.67|0.40|<0.0001
72536810|NCT03170271|144604319|SUPERIORITY||LS Mean difference|20.11||||0.0031|TWO_SIDED|95.0|6.79|33.44|||Repeated measures analysis||Model: Change from baseline in PEF = Treatment + baseline PEF + region + number of exacerbations in previous year + maintenance OCS use at baseline + visit + treatment by visit.|Change from run-in baseline in morning PEF at Week 24 was compared between the benralizumab group and placebo group using a restricted maximum likelihood based on a MMRM analysis.||33.44|6.79|0.0031
72536811|NCT03170271|144604319|SUPERIORITY||LS Mean Difference|23.09||||0.0008|TWO_SIDED|95.0|9.62|36.55|||Repeated measures analysis||Model: Change from baseline in PEF = Treatment + baseline PEF + region + number of exacerbations in previous year + maintenance OCS use at baseline + visit + treatment by visit.|Change from run-in baseline in evening PEF at Week 24 was compared between the benralizumab group and placebo group using a restricted maximum likelihood based on a MMRM analysis.||36.55|9.62|0.0008
72573352|NCT03589768|144673275|SUPERIORITY||Ratio|0.9||||0.4237|TWO_SIDED|95.0|0.6|1.2|||t-test, 2 sided|Test compares difference in log values.|Difference in log values back transformed into ratio.|Statistical analysis for delivery time point|The ratio is calculated as the GMC of the BOOSTRIX group divided by the GMC of the Td group.|1.2|0.6|0.4237
72573353|NCT03589768|144673275|SUPERIORITY||Ratio|0.7||||0.1607|TWO_SIDED|95.0|0.4|1.2|||t-test, 2 sided|Test compares difference in log values.|Difference in log values back transformed into ratio.|Statistical analysis for 6 months after delivery time point|The ratio is calculated as the GMC of the BOOSTRIX group divided by the GMC of the Td group.|1.2|0.4|0.1607
72573354|NCT03589768|144673276|SUPERIORITY||Ratio|13.7|||<|0.0001|TWO_SIDED|95.0|10.2|18.3|||t-test, 2 sided|Test compares difference in log values.|Difference in log values back transformed into ratio.|Statistical analysis for birth time point|The ratio is calculated as the GMC of the BOOSTRIX group divided by the GMC of the Td group.|18.3|10.2|<0.0001
72573355|NCT03589768|144673276|SUPERIORITY||Ratio|10.8|||<|0.0001|TWO_SIDED|95.0|8.0|14.5|||t-test, 2 sided|Test compares difference in log values.|Difference in log values back transformed into ratio.|Statistical analysis for prior to receipt of first dose of DTwP (approximately 6 weeks of age)|The ratio is calculated as the GMC of the BOOSTRIX group divided by the GMC of the Td group.|14.5|8.0|<0.0001
72409030|NCT04394351|144326524|SUPERIORITY||Odds Ratio (OR)|46.7|||<|0.0001|TWO_SIDED|95.0|5.47|399.54|||Cochran-Mantel-Haenszel|p-value was derived by CMH test stratified by baseline weight group.|Odds ratio and corresponding CI are based on CMH test stratified by baseline weight group.|Part A: Dupilumab Low Dose versus Part A: Pooled Placebo||399.54|5.47|<0.0001
72409031|NCT04394351|144326525|SUPERIORITY||Odds Ratio (OR)|178.0|||<|0.0001|TWO_SIDED|95.0|18.84|1682.4|||Cochran-Mantel-Haenszel|p-value was derived by CMH test stratified by baseline weight group|Odds ratio and corresponding CI are based on CMH test stratified by baseline weight group|Part A: Dupilumab High Dose versus Part A: Pooled Placebo||1682.4|18.84|<0.0001
72536812|NCT03170271|144604320|SUPERIORITY||LS Mean difference|5.35||||0.0077|TWO_SIDED|95.0|1.42|9.28|||Repeated measures analysis||Model: Change from baseline in SF-36v2 score = Treatment + baseline SF-36v2 score + region + number of exacerbations in previous year + maintenance OCS use at baseline + visit + treatment by visit.|Change from baseline in SF-36v2 subscale score for physical functioning at Week 24 was compared between the benralizumab group and placebo group using a restricted maximum likelihood based on a MMRM analysis.||9.28|1.42|0.0077
72536813|NCT03170271|144604320|SUPERIORITY||LS Mean Difference|6.8||||0.0022|TWO_SIDED|95.0|2.45|11.14|||Repeated measures analysis||Model: Change from baseline in SF-36v2 score = Treatment + baseline SF-36v2 score + region + number of exacerbations in previous year + maintenance OCS use at baseline + visit + treatment by visit.|Change from baseline in SF-36v2 subscale score for role limitations due to physical health at Week 24 was compared between the benralizumab group and placebo group using a restricted maximum likelihood based on a MMRM analysis.||11.14|2.45|0.0022
72573356|NCT03589768|144673276|SUPERIORITY||Ratio|10.2|||<|0.0001|TWO_SIDED|95.0|6.9|15.2|||t-test, 2 sided|Test compares difference in log values.|Difference in log values back transformed into ratio. Test compares difference in log values.|Statistical analysis for one month after receipt of first dose of DTwP (approximately 10 weeks of age) time point|The ratio is calculated as the GMC of the BOOSTRIX group divided by the GMC of the Td group.|15.2|6.9|<0.0001
72573357|NCT03589768|144673276|SUPERIORITY||Ratio|2.1||||0.0002|TWO_SIDED|95.0|1.4|3.0|||t-test, 2 sided|Test compares difference in log values.|Difference in log values back transformed into ratio.|Statistical analysis for one month after receipt of last dose of DTwP (approximately 18 weeks of age) time point|The ratio is calculated as the GMC of the BOOSTRIX group divided by the GMC of the Td group.|3.0|1.4|0.0002
72409032|NCT04394351|144326525|SUPERIORITY||Odds Ratio (OR)|55.3|||<|0.0001|TWO_SIDED|95.0|7.45|410.23||P-value is not adjusted for multiple comparisons|Cochran-Mantel-Haenszel|p-value was derived by CMH test stratified by baseline weight group|Odds ratio and corresponding CI are based on CMH test stratified by baseline weight group|Part A: Dupilumab Low Dose versus Part A: Pooled Placebo||410.23|7.45|<0.0001
72573358|NCT03589768|144673276|SUPERIORITY||Ratio|1.2||||0.4828|TWO_SIDED|95.0|0.8|1.7|||t-test, 2 sided|Test compares difference in log values.|Difference in log values back transformed into ratio.|Statistical analysis for 6 months of age time point|The ratio is calculated as the GMC of the BOOSTRIX group divided by the GMC of the Td group.|1.7|0.8|0.4828
72573359|NCT03589768|144673277|SUPERIORITY||Ratio|46.4|||<|0.0001|TWO_SIDED|95.0|26.6|81.0|||t-test, 2 sided|Test compares difference in log values.|Difference in log values back transformed into ratio.|Statistical analysis for birth time point|The ratio is calculated as the GMC of the BOOSTRIX group divided by the GMC of the Td group.|81.0|26.6|<0.0001
72573360|NCT03589768|144673277|SUPERIORITY||Ratio|39.5|||<|0.0001|TWO_SIDED|95.0|24.0|65.0|||t-test, 2 sided|Test compares difference in log values.|Difference in log values back transformed into ratio.|Statistical analysis for prior to receipt of first dose of DTwP (approximately 6 weeks of age)|The ratio is calculated as the GMC of the BOOSTRIX group divided by the GMC of the Td group.|65.0|24.0|<0.0001
72573361|NCT03589768|144673277|SUPERIORITY||Ratio|10.4|||<|0.0001|TWO_SIDED|95.0|6.1|17.9|||t-test, 2 sided|Test compares difference in log values.|Difference in log values back transformed into ratio.|Statistical analysis for one month after receipt of first dose of DTwP (approximately 10 weeks of age) time point|The ratio is calculated as the GMC of the BOOSTRIX group divided by the GMC of the Td group.|17.9|6.1|<0.0001
72573362|NCT03589768|144673277|SUPERIORITY||Ratio|0.6||||0.0746|TWO_SIDED|95.0|0.3|1.1|||t-test, 2 sided|Test compares difference in log values.|Difference in log values back transformed into ratio.|Statistical analysis for one month after receipt of last dose of DTwP (approximately 18 weeks of age) time point|The ratio is calculated as the GMC of the BOOSTRIX group divided by the GMC of the Td group.|1.1|0.3|0.0746
72573363|NCT03589768|144673277|SUPERIORITY||Ratio|0.7||||0.1532|TWO_SIDED|95.0|0.5|1.1|||t-test, 2 sided|Test compares difference in log values.|Difference in log values back transformed into ratio.|Statistical analysis for 6 months of age time point|The ratio is calculated as the GMC of the BOOSTRIX group divided by the GMC of the Td group.|1.1|0.5|0.1532
72573364|NCT03589768|144673278|SUPERIORITY||Ratio|0.7||||0.0022|TWO_SIDED|95.0|0.6|0.9|||t-test, 2 sided|Test compares difference in log values.|Difference in log values back transformed into ratio.|Statistical analysis for birth time point|The ratio is calculated as the GMC of the BOOSTRIX group divided by the GMC of the Td group.|0.9|0.6|0.0022
72409033|NCT04394351|144326526|SUPERIORITY||LS mean difference|-107.07|||<|0.0001|TWO_SIDED|95.0|-139.249|-74.9|||ANCOVA||CI was based on treatment difference (Dupilumab group vs. placebo) of the LS mean change using ANCOVA model with baseline measurement as covariate and the treatment, baseline weight group strata as fixed factors.|Part A: Dupilumab High Dose versus Part A: Pooled Placebo||-74.900|-139.249|<0.0001
72409034|NCT04394351|144326526|SUPERIORITY||LS mean difference|-98.92|||<|0.0001|TWO_SIDED|95.0|-132.463|-65.37||P-value is not adjusted for multiple comparisons|ANCOVA||CI was based on treatment difference (Dupilumab group vs. placebo) of the LS mean change using ANCOVA model with baseline measurement as covariate and the treatment, baseline weight group strata as fixed factors.|Part A: Dupilumab Low Dose versus Part A: Pooled Placebo||-65.370|-132.463|<0.0001
72536814|NCT03170271|144604320|SUPERIORITY||LS Mean Difference|3.07||||0.1741|TWO_SIDED|95.0|-1.36|7.5|||Repeated measures analysis||Model: Change from baseline in SF-36v2 score = Treatment + baseline SF-36v2 score + region + number of exacerbations in previous year + maintenance OCS use at baseline + visit + treatment by visit.|Change from baseline in SF-36v2 subscale score for bodily pain at Week 24 was compared between the benralizumab group and placebo group using a restricted maximum likelihood based on a MMRM analysis.||7.50|-1.36|0.1741
72536815|NCT03170271|144604320|SUPERIORITY||LS Mean Difference|5.62||||0.0009|TWO_SIDED|95.0|2.32|8.92|||Repeated measures analysis||Model: Change from baseline in SF-36v2 score = Treatment + baseline SF-36v2 score + region + number of exacerbations in previous year + maintenance OCS use at baseline + visit + treatment by visit.|Change from baseline in SF-36v2 subscale score for general health perceptions at Week 24 was compared between the benralizumab group and placebo group using a restricted maximum likelihood based on a MMRM analysis.||8.92|2.32|0.0009
72536816|NCT03170271|144604320|SUPERIORITY||LS Mean Difference|5.51||||0.0025|TWO_SIDED|95.0|1.95|9.08|||Repeated measures analysis||Model: Change from baseline in SF-36v2 score = Treatment + baseline SF-36v2 score + region + number of exacerbations in previous year + maintenance OCS use at baseline + visit + treatment by visit.|Change from baseline in SF-36v2 subscale score for vitality at Week 24 was compared between the benralizumab group and placebo group using a restricted maximum likelihood based on a MMRM analysis.||9.08|1.95|0.0025
72536817|NCT03170271|144604320|SUPERIORITY||LS Mean Difference|3.12||||0.1583|TWO_SIDED|95.0|-1.22|7.46|||Repeated measures analysis||Model: Change from baseline in SF-36v2 score = Treatment + baseline SF-36v2 score + region + number of exacerbations in previous year + maintenance OCS use at baseline + visit + treatment by visit.|Change from baseline in SF-36v2 subscale score for social functioning at Week 24 was compared between the benralizumab group and placebo group using a restricted maximum likelihood based on a MMRM analysis.||7.46|-1.22|0.1583
72536818|NCT03170271|144604320|SUPERIORITY||LS Mean Difference|2.44||||0.2103|TWO_SIDED|95.0|-1.38|6.27|||Repeated measures analysis||Model: Change from baseline in SF-36v2 score = Treatment + baseline SF-36v2 score + region + number of exacerbations in previous year + maintenance OCS use at baseline + visit + treatment by visit.|Change from baseline in SF-36v2 subscale score for role limitations due to emotional problems at Week 24 was compared between the benralizumab group and placebo group using a restricted maximum likelihood based on a MMRM analysis.||6.27|-1.38|0.2103
72536819|NCT03170271|144604320|SUPERIORITY||LS Mean Difference|1.68||||0.2581|TWO_SIDED|95.0|-1.23|4.59|||Repeated measures analysis||Model: Change from baseline in SF-36v2 score = Treatment + baseline SF-36v2 score + region + number of exacerbations in previous year + maintenance OCS use at baseline + visit + treatment by visit.|Change from baseline in SF-36v2 subscale score for mental health at Week 24 was compared between the benralizumab group and placebo group using a restricted maximum likelihood based on a MMRM analysis.||4.59|-1.23|0.2581
72536820|NCT03170271|144604320|SUPERIORITY||LS Mean Difference|2.32||||0.0022|TWO_SIDED|95.0|0.84|3.81|||Repeated measures analysis||Model: Change from baseline in SF-36v2 score = Treatment + baseline SF-36v2 score + region + number of exacerbations in previous year + maintenance OCS use at baseline + visit + treatment by visit.|Change from baseline in SF-36v2 physical health component summary score at Week 24 was compared between the benralizumab group and placebo group using a restricted maximum likelihood based on a MMRM analysis.||3.81|0.84|0.0022
72536821|NCT03170271|144604320|SUPERIORITY||LS Mean Difference|0.87||||0.2751|TWO_SIDED|95.0|-0.7|2.44|||Repeated measures analysis||Model: Change from baseline in SF-36v2 score = Treatment + baseline SF-36v2 score + region + number of exacerbations in previous year + maintenance OCS use at baseline + visit + treatment by visit.|Change from baseline in SF-36v2 mental health component summary score at Week 24 was compared between the benralizumab group and placebo group using a restricted maximum likelihood based on a MMRM analysis.||2.44|-0.70|0.2751
72536822|NCT03170271|144604321|SUPERIORITY||Odds Ratio (OR)|1.55||||0.0233|TWO_SIDED|95.0|1.06|2.25|||Regression, Logistic||Model: ln (1/(1-p)) = Treatment + baseline score + region + number of exacerbations in previous year + maintenance OCS use at baseline, where p is the proportion of patients being a responder.|Estimate of the log odds of being a responder classified as type 'Improvement' at Week 24 in the benralizumab group compared to the placebo group using a logistic regression.||2.25|1.06|0.0233
72536823|NCT03170271|144604321|SUPERIORITY||Odds Ratio (OR)|1.48||||0.0401|TWO_SIDED|95.0|1.02|2.16|||Regression, Logistic||Model: ln (1/(1-p)) = Treatment + baseline score + region + number of exacerbations in previous year + maintenance OCS use at baseline, where p is the proportion of patients being a responder.|Estimate of the log odds of being a responder classified as type 'Important Improvement' at Week 24 in the benralizumab group compared to the placebo group using a logistic regression.||2.16|1.02|0.0401
72536824|NCT03170271|144604322|SUPERIORITY||Odds Ratio (OR)|2.05|||<|0.0001|TWO_SIDED|95.0|1.47|2.86|||Regression, Logistic||Model: ln (1/(1-p)) = Treatment + region + number of exacerbations in previous year + maintenance OCS use at baseline, where p is the proportion of patients being a responder.|Estimate of the log odds of being a CGI-C responder classified as type 'Much improved' at Week 24 in the benralizumab group compared to the placebo group using a logistic regression.||2.86|1.47|<0.0001
72573365|NCT03589768|144673278|SUPERIORITY||Ratio|0.7||||0.0008|TWO_SIDED|95.0|0.5|0.8|||t-test, 2 sided|Test compares difference in log values.|Difference in log values back transformed into ratio.|Statistical analysis for prior to receipt of first dose of DTwP (approximately 6 weeks of age)|The ratio is calculated as the GMC of the BOOSTRIX group divided by the GMC of the Td group.|0.8|0.5|0.0008
72573366|NCT03589768|144673278|SUPERIORITY||Ratio|0.7||||0.0261|TWO_SIDED|95.0|0.5|1.0|||t-test, 2 sided|Test compares difference in log values.|Difference in log values back transformed into ratio.|Statistical analysis for one month after receipt of first dose of DTwP (approximately 10 weeks of age) time point|The ratio is calculated as the GMC of the BOOSTRIX group divided by the GMC of the Td group.|1.0|0.5|0.0261
72573367|NCT03589768|144673278|SUPERIORITY||Ratio|0.6||||0.0532|TWO_SIDED|95.0|0.3|1.0|||t-test, 2 sided|Test compares difference in log values.|Difference in log values back transformed into ratio.|Statistical analysis for one month after receipt of last dose of DTwP (approximately 18 weeks of age) time point|The ratio is calculated as the GMC of the BOOSTRIX group divided by the GMC of the Td group.|1.0|0.3|0.0532
72626717|NCT03229538|144782303|SUPERIORITY|It was estimated that 1200 patients (600 per trial group) would provide the trial with more than 90% power to detect superiority of methylprednisolone.|Adjusted Odds Ratio|0.83||||0.228|TWO_SIDED|95.0|0.61|1.13|||Regression, Logistic|||||1.13|0.61|0.228
72536825|NCT03170271|144604322|SUPERIORITY||Odds Ratio (OR)|3.45||||0.0003|TWO_SIDED|95.0|1.77|6.7|||Regression, Logistic||Model: ln (1/(1-p)) = Treatment + region + number of exacerbations in previous year + maintenance OCS use at baseline, where p is the proportion of patients being a responder.|Estimate of the log odds of being a CGI-C responder classified as type 'Very much improved' at Week 24 in the benralizumab group compared to the placebo group using a logistic regression.||6.70|1.77|0.0003
72536826|NCT03170271|144604322|SUPERIORITY||Odds Ratio (OR)|2.06|||<|0.0001|TWO_SIDED|95.0|1.48|2.87|||Regression, Logistic||Model: ln (1/(1-p)) = Treatment + region + number of exacerbations in previous year + maintenance OCS use at baseline, where p is the proportion of patients being a responder.|Estimate of the log odds of being a PGI-C responder classified as type 'Much improved' at Week 24 in the benralizumab group compared to the placebo group using a logistic regression.||2.87|1.48|<0.0001
72573368|NCT03589768|144673278|SUPERIORITY||Ratio|0.9||||0.5587|TWO_SIDED|95.0|0.5|1.4|||t-test, 2 sided|Test compares difference in log values.|Difference in log values back transformed into ratio.|Statistical analysis for 6 months of age time point|The ratio is calculated as the GMC of the BOOSTRIX group divided by the GMC of the Td group.|1.4|0.5|0.5587
72409035|NCT04394351|144326527|SUPERIORITY||LS mean difference|-0.902|||<|0.0001|TWO_SIDED|95.0|-1.0325|-0.7714|||ANCOVA||CI was based on treatment difference (Dupilumab group vs. placebo) of the LS mean change using ANCOVA model with baseline measurement as covariate and the treatment, baseline weight group strata as fixed factors.|Part A: Dupilumab High Dose versus Part A: Pooled Placebo||-0.7714|-1.0325|<0.0001
72626718|NCT03229538|144782304|SUPERIORITY|It was estimated that 1200 patients (600 per trial group) would provide the trial with more than 90% power to detect superiority of methylprednisolone over placebo.|Percent Difference|-1.8|||||TWO_SIDED|95.0|-4.0|0.4||||||||0.4|-4.0|
72573369|NCT03589768|144673279|SUPERIORITY||Ratio|0.9||||0.5056|TWO_SIDED|95.0|0.6|1.3|||t-test, 2 sided|Test compares difference in log values.|Difference in log values back transformed into ratio.|Statistical analysis for birth time point|The ratio is calculated as the GMC of the BOOSTRIX group divided by the GMC of the Td group.|1.3|0.6|0.5056
72573370|NCT03589768|144673279|SUPERIORITY||Ratio|1.0||||0.9466|TWO_SIDED|95.0|0.7|1.5|||t-test, 2 sided|Test compares difference in log values.|Difference in log values back transformed into ratio.|Statistical analysis for prior to receipt of first dose of DTwP (approximately 6 weeks of age)|The ratio is calculated as the GMC of the BOOSTRIX group divided by the GMC of the Td group.|1.5|0.7|0.9466
72573371|NCT03589768|144673279|SUPERIORITY||Ratio|1.1||||0.6911|TWO_SIDED|95.0|0.6|2.0|||t-test, 2 sided|Test compares difference in log values.|Difference in log values back transformed into ratio.|Statistical analysis for one month after receipt of first dose of DTwP (approximately 10 weeks of age) time point|The ratio is calculated as the GMC of the BOOSTRIX group divided by the GMC of the Td group.|2.0|0.6|0.6911
72626719|NCT03229538|144782305|SUPERIORITY|It was estimated that 1200 patients (600 per trial group) would provide the trial with more than 90% power to detect superiority of methylprednisolone over placebo.|Adjusted Odds Ratio|0.79||||0.309|TWO_SIDED|95.0|0.5|1.25|||Regression, Logistic|||||1.25|0.50|0.309
72626720|NCT03229538|144782306|SUPERIORITY|It was estimated that 1200 patients (600 per trial group) would provide the trial with more than 90% power to detect superiority of methylprednisolone over placebo.|Adjusted Odds Ratio|0.91||||0.723|TWO_SIDED|95.0|0.52|1.57|||Regression, Logistic|||||1.57|0.52|0.723
72573372|NCT03589768|144673279|SUPERIORITY||Ratio|0.6||||0.0952|TWO_SIDED|95.0|0.3|1.1|||t-test, 2 sided|Test compares difference in log values.|Difference in log values back transformed into ratio.|Statistical analysis for one month after receipt of last dose of DTwP (approximately 18 weeks of age) time point|The ratio is calculated as the GMC of the BOOSTRIX group divided by the GMC of the Td group.|1.1|0.3|0.0952
72626721|NCT03229538|144782308|SUPERIORITY||Adjusted Odds Ratio|0.86||||0.256|TWO_SIDED|95.0|0.67|1.11|||Regression, Logistic|||||1.11|0.67|0.256
72626722|NCT02735200|144782314|SUPERIORITY||Mean Difference (Final Values)|1.67||||0.9|TWO_SIDED|||||the p value correspond to the pretreatment time frame.|t-test, 2 sided|||||||0.9
72626723|NCT02735200|144782314|SUPERIORITY||Mean Difference (Final Values)|26.66|||<|0.001|TWO_SIDED|||||p value corresponds to the post treatment time frame.|t-test, 2 sided|||||||<0.001
72626724|NCT01164007|144782333|SUPERIORITY_OR_OTHER|||||||0.071|||||||One-sample exact binomial test|||The observed percentage of participants with CR or PR was compared with the expected proportion under the null hypothesis (0.10) and analyzed for statistical significance using a one-sample exact binomial test.||||0.071
72626725|NCT01259011|144782378|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.9|||<|0.05|TWO_SIDED|95.0|1.1|3.3|||Mixed Models Analysis|||||3.3|1.1|<.05
72626726|NCT01259011|144782379|SUPERIORITY||Slope|-1.2||||0.12|TWO_SIDED|95.0|-2.8|0.3||HADS-anxiety|Regression, Linear|||||0.3|-2.8|0.12
72626727|NCT01259011|144782379|SUPERIORITY||Slope|-2.2|||<|0.05|TWO_SIDED|95.0|-4.2|-0.3||HADS-depression|Regression, Linear|||||-0.3|-4.2|<0.05
72369224|NCT00611026|144248557|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with country and treatment as factors, and ranked baseline value as a covariate.||Treatment difference fesoterodine vs placebo at Week 4.||||<0.0001
72626728|NCT01259011|144782380|SUPERIORITY||Slope|-4.0||||0.21|TWO_SIDED|95.0|-10.2|2.2|||Regression, Linear|||||2.2|-10.2|0.21
72626729|NCT03510273|144782398|OTHER|"Type of statistical test: Independence~Description: Adequacy of baseline image"||||||0.396|||||||Fisher Exact|||||||0.396
72626730|NCT03510273|144782398|OTHER|"Type of statistical test: Independence~Description: Squamous columnar junction visibility"||||||0.351|||||||Fisher Exact|||||||0.351
72626731|NCT03510273|144782398|OTHER|"Type of statistical test: Independence~Description: Visible abnormal areas"||||||0.774|||||||Fisher Exact|||||||0.774
72626732|NCT03510273|144782398|OTHER|"Type of statistical test: Independence~Description: Location of the lesion"||||||1|||||||Fisher Exact|||||||1
72626733|NCT03510273|144782398|OTHER|"Type of statistical test: Independence~Description: Mosaic of the worst lesion"||||||0.36|||||||Fisher Exact|||||||0.36
72369225|NCT00611026|144248557|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED|||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with country and treatment as factors, and ranked baseline value as a covariate.||Treatment difference Tolterodine ER vs placebo at Week 4.||||0.0020
72409036|NCT04394351|144326527|SUPERIORITY||LS mean difference|-0.78|||<|0.0001|TWO_SIDED|95.0|-0.917|-0.644||P-value is not adjusted for multiple comparisons|ANCOVA||CI was based on treatment difference (Dupilumab group vs. placebo) of the LS mean change using ANCOVA model with baseline measurement as covariate and the treatment, baseline weight group strata as fixed factors.|Part A: Dupilumab Low Dose versus Part A: Pooled Placebo||-0.6440|-0.9170|<0.0001
72409037|NCT04394351|144326528|SUPERIORITY||LS mean difference|-0.883|||<|0.0001|TWO_SIDED|95.0|-1.0095|-0.7568|||ANCOVA||CI was based on treatment difference (Dupilumab group vs. placebo) of the LS mean change using ANCOVA model with baseline measurement as covariate and the treatment, baseline weight group strata as fixed factors.|Part A: Dupilumab High Dose versus Part A: Pooled Placebo||-0.7568|-1.0095|<0.0001
72409038|NCT04394351|144326528|SUPERIORITY||LS mean difference|-0.769|||<|0.0001|TWO_SIDED|95.0|-0.9013|-0.6362||P-value is not adjusted for multiple comparisons|ANCOVA||CI was based on treatment difference (Dupilumab group vs. placebo) of the LS mean change using ANCOVA model with baseline measurement as covariate and the treatment, baseline weight group strata as fixed factors.|Part A: Dupilumab Low Dose versus Part A: Pooled Placebo||-0.6362|-0.9013|<0.0001
72409039|NCT04394351|144326529|SUPERIORITY||Hodges-Lehmann estimator|-2.22|||<|0.0001|TWO_SIDED|95.0|-2.44|-1.95|||Wilcoxon rank-sum test||Median Difference is Dupilumab minus Placebo|Part A: Dupilumab High Dose versus Part A: Pooled Placebo||-1.9500|-2.4400|<0.0001
72409040|NCT04394351|144326529|SUPERIORITY||Hodges-Lehmann estimator|-2.19|||<|0.0001|TWO_SIDED|95.0|-2.45|-1.82||P-value is not adjusted for multiple comparisons|Wilcoxon rank-sum test||Median Difference is Dupilumab minus Placebo|Part A: Dupilumab Low Dose versus Part A: Pooled Placebo||-1.8200|-2.4500|<0.0001
72536827|NCT03170271|144604322|SUPERIORITY||Odds Ratio (OR)|3.02|||<|0.0001|TWO_SIDED|95.0|2.02|4.51|||Regression, Logistic||Model: ln (1/(1-p)) = Treatment + region + number of exacerbations in previous year + maintenance OCS use at baseline, where p is the proportion of patients being a responder.|Estimate of the log odds of being a PGI-C responder classified as type 'Very much improved' at Week 24 in the benralizumab group compared to the placebo group using a logistic regression.||4.51|2.02|<0.0001
72409041|NCT04394351|144326530|SUPERIORITY||Hodges-Lehmann estimator|-2.84|||<|0.0001|TWO_SIDED|95.0|-3.35|-1.96|||Wilcoxon rank-sum test||Median Difference is Dupilumab minus Placebo|Part A: Dupilumab High Dose versus Part A: Pooled Placebo||-1.9600|-3.3500|<0.0001
72536828|NCT03170271|144604323|SUPERIORITY||LS Mean difference|-1.15|||<|0.0001|TWO_SIDED|95.0|-1.62|-0.68|||Repeated measures analysis||Model: Change from baseline in average PSIA score (top 3 ranked) =Treatment + baseline average PSIA score (top 3 ranked) + region + number of exacerbations in previous year + maintenance OCS use at baseline + visit + treatment by visit.|Change from baseline in PSIA severity score for the average of top 3 ranked symptoms/impairments at Week 24 was compared between the benralizumab group and placebo group using a restricted maximum likelihood based on a MMRM analysis.||-0.68|-1.62|<0.0001
72536829|NCT03170271|144604323|SUPERIORITY||LS Mean difference|-1.15|||<|0.0001|TWO_SIDED|95.0|-1.64|-0.66|||Repeated measures analysis||Model: Change from baseline in PSIA score (top ranked) =Treatment + baseline PSIA score (top ranked) + region + number of exacerbations in previous year + maintenance OCS use at baseline + visit + treatment by visit.|Change from baseline in PSIA severity score of top ranked symptom/impairment at Week 24 was compared between the benralizumab group and placebo group using a restricted maximum likelihood based on a MMRM analysis.||-0.66|-1.64|<0.0001
72409042|NCT04394351|144326530|SUPERIORITY||Hodges-Lehmann estimator|-2.7|||<|0.0001|TWO_SIDED|95.0|-3.31|-1.62||P-value is not adjusted for multiple comparisons|Wilcoxon rank-sum test||Median Difference is Dupilumab minus Placebo|Part A: Dupilumab Low Dose versus Part A: Pooled Placebo||-1.6200|-3.3100|<0.0001
72409043|NCT04394351|144326531|SUPERIORITY||LS mean difference|-3.8|||<|0.0001|TWO_SIDED|95.0|-4.94|-2.63|||ANCOVA||CI was based on treatment difference (Dupilumab group vs. placebo) of the LS mean change using ANCOVA model with baseline measurement as covariate and the treatment, baseline weight group strata as fixed factors.|Part A: Dupilumab High Dose versus Part A: Pooled Placebo||-2.63|-4.94|<0.0001
72409044|NCT04394351|144326531|SUPERIORITY||LS mean difference|-3.3|||<|0.0001|TWO_SIDED|95.0|-4.59|-2.1||P-value is not adjusted for multiple comparisons|ANCOVA||CI was based on treatment difference (Dupilumab group vs. placebo) of the LS mean change using ANCOVA model with baseline measurement as covariate and the treatment, baseline weight group strata as fixed factors.|Part A: Dupilumab Low Dose versus Part A: Pooled Placebo||-2.10|-4.59|<0.0001
72409045|NCT04394351|144326532|SUPERIORITY||LS mean difference|-0.1||||0.1526|TWO_SIDED|95.0|-0.244|0.038|||ANCOVA||CI was based on treatment difference (Dupilumab group vs. placebo) of the LS mean change using ANCOVA model with baseline measurement as covariate and the treatment, baseline weight group strata as fixed factors.|Part A: Dupilumab High Dose versus Part A: Pooled Placebo||0.038|-0.244|0.1526
72409046|NCT04394351|144326532|SUPERIORITY||LS mean difference|0.0||||0.9533|TWO_SIDED|95.0|-0.155|0.146||P-value is not adjusted for multiple comparisons|ANCOVA||CI was based on treatment difference (Dupilumab group vs. placebo) of the LS mean change using ANCOVA model with baseline measurement as covariate and the treatment, baseline weight group strata as fixed factors.|Part A: Dupilumab Low Dose versus Part A: Pooled Placebo||0.146|-0.155|0.9533
72409047|NCT04394351|144326533|SUPERIORITY||LS mean difference|1.45||||0.1507|TWO_SIDED|95.0|-0.527|3.422||P-value is not adjusted for multiple comparisons|ANCOVA||CI was based on treatment difference (Dupilumab group vs. placebo) of the LS mean change using ANCOVA model with baseline measurement as covariate and the treatment, baseline weight group strata as fixed factors.|Part A: Dupilumab High Dose versus Part A: Pooled Placebo||3.422|-0.527|0.1507
72409048|NCT04394351|144326533|SUPERIORITY||LS mean difference|0.0||||0.9965|TWO_SIDED|95.0|-2.107|2.117||P-value is not adjusted for multiple comparisons|ANCOVA||CI was based on treatment difference (Dupilumab group vs. placebo) of the LS mean change using ANCOVA model with baseline measurement as covariate and the treatment, baseline weight group strata as fixed factors.|Part A: Dupilumab Low Dose versus Part A: Pooled Placebo||2.117|-2.107|0.9965
72626734|NCT03510273|144782398|OTHER|"Type of Statistical Test: Independence~Description: Acetowhite changes"||||||0.881|||||||Fisher Exact|||||||0.881
72626735|NCT03510273|144782398|OTHER|"Type of Statistical Test: Independence~Description: Border of the worst lesion"||||||0.829|||||||Fisher Exact|||||||0.829
72626736|NCT03510273|144782398|OTHER|"Type of Statistical Test: Independence~Description: Possible diagnosis"||||||1|||||||Fisher Exact|||||||1
72573373|NCT03589768|144673279|SUPERIORITY||Ratio|1.2||||0.4134|TWO_SIDED|95.0|0.8|2.0|||t-test, 2 sided|Test compares difference in log values.|Difference in log values back transformed into ratio.|Statistical analysis for 6 months of age time point|The ratio is calculated as the GMC of the BOOSTRIX group divided by the GMC of the Td group.|2.0|0.8|0.4134
72573374|NCT03589768|144673280|SUPERIORITY||Ratio|1.6||||0.0859|TWO_SIDED|95.0|0.9|2.6|||t-test, 2 sided|Test compares difference in log values.|Difference in log values back transformed into ratio.|Statistical analysis for birth time point|The ratio is calculated as the GMC of the BOOSTRIX group divided by the GMC of the Td group.|2.6|0.9|0.0859
72573375|NCT03589768|144673280|SUPERIORITY||Ratio|1.4||||0.204|TWO_SIDED|95.0|0.8|2.3|||t-test, 2 sided|Test compares difference in log values.|Difference in log values back transformed into ratio.|Statistical analysis for prior to receipt of first dose of DTwP (approximately 6 weeks of age)|The ratio is calculated as the GMC of the BOOSTRIX group divided by the GMC of the Td group.|2.3|0.8|0.2040
72573376|NCT03589768|144673280|SUPERIORITY||Ratio|1.6||||0.0763|TWO_SIDED|95.0|1.0|2.7|||t-test, 2 sided|Test compares difference in log values.|Difference in log values back transformed into ratio.|Statistical analysis for one month after receipt of first dose of DTwP (approximately 10 weeks of age) time point|The ratio is calculated as the GMC of the BOOSTRIX group divided by the GMC of the Td group.|2.7|1.0|0.0763
72369202|NCT00611026|144248554|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Comparison fesoterodine vs tolterodine ER performed only if statistical significance favoring fesoterodine achieved for fesoterodine vs placebo to preserve overall alpha level at 5%; pairwise comparison also performed for tolterodine ER vs placebo.|Van Elteren's Test|P-value based on Van Elteren's Test (a stratified Wilcoxon-Mann Whitney test) adjusted by baseline UUI quartile.||"Treatment difference fesoterodine versus (vs) placebo at Week 12. Treatment effects estimated by Winsorized means (5% of the tails were censored, ie, replaced with the value at the fifth (5th) and ninety-fifth (95th) percentile, respectively).~If normality assumptions were severely violated (proportion of non normal observations \> 5%) a non-parametric analysis was to be conducted using Van Elteren's test stratified by baseline quartile of the diary variable analyzed."||||<0.0001
72573377|NCT03589768|144673280|SUPERIORITY||Ratio|0.5||||0.0836|TWO_SIDED|95.0|0.2|1.1|||t-test, 2 sided|Test compares difference in log values.|Difference in log values back transformed into ratio.|Statistical analysis for one month after receipt of last dose of DTwP (approximately 18 weeks of age) time point|The ratio is calculated as the GMC of the BOOSTRIX group divided by the GMC of the Td group.|1.1|0.2|0.0836
72626737|NCT03510273|144782398|OTHER|"Type of Statistical Test: Independence~Description: Baseline histology"||||||1|||||||Fisher Exact|||||||1
72626738|NCT03510273|144782398|OTHER|"Type of Statistical Test: Independence~Description: Size of the worst lesion (% coverage)"||||||0.493|||||||Fisher Exact|||||||0.493
72573378|NCT03589768|144673280|SUPERIORITY||Ratio|0.6||||0.0672|TWO_SIDED|95.0|0.3|1.0|||t-test, 2 sided|Test compares difference in log values.|Difference in log values back transformed into ratio.|Statistical analysis for 6 months of age time point|The ratio is calculated as the GMC of the BOOSTRIX group divided by the GMC of the Td group.|1.0|0.3|0.0672
72626739|NCT01276106|144782399|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.35|STANDARD_ERROR_OF_MEAN|0.175||0.044|TWO_SIDED|95.0|-0.7|-0.01||No adjustments for multiple comparisons were made and a value of p\<0.05 was considered statistically significant.|ANCOVA|||Change from baseline in HbA1c was analyzed using an analysis of covariance model with change in HbA1c as the dependent variable, treatment as a fixed effect, and baseline HbA1c as a covariate.||-0.01|-0.70|0.044
72626740|NCT01276106|144782399|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.29|STANDARD_ERROR_OF_MEAN|0.176||0.0979|TWO_SIDED|95.0|-0.64|0.05||No adjustments for multiple comparisons were made and a value of p\<0.05 was considered statistically significant.|ANCOVA|||Change from baseline in HbA1c was analyzed using an analysis of covariance model with change in HbA1c as the dependent variable, treatment as a fixed effect, and baseline HbA1c as a covariate.||0.05|-0.64|0.0979
72626741|NCT01276106|144782399|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.174||0.2643|TWO_SIDED|95.0|-0.54|0.15||No adjustments for multiple comparisons were made and a value of p\<0.05 was considered statistically significant.|ANCOVA|||Change from baseline in HbA1c was analyzed using an analysis of covariance model with change in HbA1c as the dependent variable, treatment as a fixed effect, and baseline HbA1c as a covariate.||0.15|-0.54|0.2643
72626742|NCT00867035|144782412|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon (Mann-Whitney)|||Rosenberg scores compared baseline to 1 hour by Mann-Whitney U test.||||<0.001
72626743|NCT00867035|144782412|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon (Mann-Whitney)|||mann whitney u to compare rosenberg score baseline to 1 hour||||<.001
72626744|NCT00867035|144782412|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon (Mann-Whitney)|||baseline to 2 hours||||<0.001
72626745|NCT00867035|144782412|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon (Mann-Whitney)|||baseline to 4 hours||||<0.001
72626746|NCT00867035|144782412|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon (Mann-Whitney)|||baseline to 1 week||||<0.001
72573379|NCT02213510|144673286|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||t-test, 2 sided|||||||<0.001
72536830|NCT03170271|144604324|SUPERIORITY||LS Mean difference|-8.91||||0.0204|TWO_SIDED|95.0|-16.42|-1.4|||Repeated measures analysis||Model: Change from baseline in SNOT-22 total score = Treatment + baseline SNOT-22 total score + region + number of exacerbations in previous year + maintenance OCS use at baseline + visit + treatment by visit.|Change from baseline in SNOT-22 total score at Week 24 was compared between the benralizumab group and placebo group using a restricted maximum likelihood based on a MMRM analysis.||-1.40|-16.42|0.0204
72573380|NCT02213510|144673287|SUPERIORITY_OR_OTHER|||||||0.655|TWO_SIDED||||||t-test, 2 sided|||||||0.655
72573381|NCT02213510|144673288|SUPERIORITY_OR_OTHER|||||||0.811|TWO_SIDED||||||t-test, 2 sided|||||||0.811
72573382|NCT02213510|144673289|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||t-test, 2 sided|||||||1.00
72573383|NCT02213510|144673290|SUPERIORITY_OR_OTHER|||||||0.462|TWO_SIDED||||||t-test, 2 sided|||||||0.462
72369035|NCT01499277|144248035|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the observed difference in the primary outcome measures (clinical cure rates) between ceftaroline group and vancomycin plus aztreonam group were calculated in both MITT and CE Populations at the TOC visit. Noninferiority was concluded if the lower limit of the 95% CI was higher than -10% in both MITT and CE Populations. If non-inferioirity was achieved then a test of superioirty was conducted if lower limit of 95% CI for the difference was \>0%.|Risk Difference (RD)|1.27|||||TWO_SIDED|95.0|-4.32|7.48||||RD is the difference in clinical cure rates (Ceftaroline minus Vancomycin/Aztreonam).CI was calculated by unstratified Miettinen and Nurminen CI.|CI for risk difference was estimated by 95% using unstratified Miettinen and Nurminen CI.|The primary objective of this study was to determine the noninferiority in the clinical cure rate for ceftaroline compared vancomycin plus azreonam group at TOC in both MITT and CE populations.||7.48|-4.32|
72536831|NCT01244516|144604350|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin is set at -5.|Mean Difference (Final Values)|0.39|STANDARD_ERROR_OF_MEAN|2.83|||TWO_SIDED|97.4|-5.91|6.7|||Mixed Models Analysis|Alpha is adjusted to 1.3% based on a Sidak multiplicity correction.|The direction of comparison is AAHP - AOA.|This comparison is between galyfilcon and lotrafilcon B. Ho: galyfilcon A -lotrafilcon B \<= -5. Ha: galyfilcon A - lotrafilcon B \> -5.||6.70|-5.91|
72536832|NCT01244516|144604350|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin is set at -5.|Mean Difference (Final Values)|0.42|STANDARD_ERROR_OF_MEAN|2.79|||TWO_SIDED|97.4|-5.96|6.79|||Mixed Models Analysis|Alpha is adjusted to 1.3% based on a Sidak multiplicity correction.|The direction of comparison is AAHP - BIO.|This comparison is between galyfilcon A and comfilcon A. Ho: gayfilcon A- comfilcon A \<= -5. Ha: galyfilcon A- comfilcon A\> -5.||6.79|-5.96|
72536833|NCT01244516|144604351|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin is set at \> 0.75. Superiority is concluded is the 97.4% CL \> 1.|Odds Ratio (OR)|1.66|||||TWO_SIDED|97.4|1.14|2.44|||Regression, Logistic|Alpha is adjusted to 1.3% based on a Sidak multiplicity correction.|The direction of comparison is AAHP/AOA.|The comparison is between galyfilcon A (AAHP) and lotrafilcon B (AOA) for comparing proportions of those with corneal staining and those without. Ho: OR = 1 for (AAHP/AOA). Ha: OR \> 1 for (AAHP/AOA).||2.44|1.14|
72536834|NCT01244516|144604351|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin is set at \> 0.75. Superiority is concluded is the 97.4% CL \> 1.|Odds Ratio (OR)|1.66|||||TWO_SIDED|97.4|1.14|2.44|||Regression, Logistic|Alpha is adjusted to 1.3% based on a Sidak multiplicity correction.||The comparison is between galyfilcon A (AAHP) and comfilcon A (BIO) for comparing proportions of those with corneal staining and those without. Ho: OR = 1 for (AAHP/BIO). Ha: OR \> 1 for (AAHP/BIO).||2.44|1.14|
72573384|NCT02213510|144673291|SUPERIORITY_OR_OTHER|||||||0.646|TWO_SIDED||||||t-test, 2 sided|||||||0.646
72573385|NCT02213510|144673292|SUPERIORITY_OR_OTHER|||||||0.51|TWO_SIDED||||||t-test, 2 sided|||||||0.510
72573386|NCT02213510|144673293|SUPERIORITY_OR_OTHER|||||||0.651|TWO_SIDED||||||t-test, 2 sided|||||||0.651
72573387|NCT02213510|144673294|SUPERIORITY_OR_OTHER|||||||0.588|TWO_SIDED||||||t-test, 2 sided|||||||0.588
72573388|NCT02213510|144673295|SUPERIORITY_OR_OTHER|||||||0.858|TWO_SIDED||||||t-test, 2 sided|||||||0.858
72573389|NCT02213510|144673296|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||t-test, 2 sided|||||||1.00
72573390|NCT05958888|144673301|SUPERIORITY||Mean Difference (Final Values)|0.99|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|||||p-values were adjusted for multiple comparisons using the Bonferroni-Holm method, correcting for six tests within each outcome. The a priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Text vs. Control||||<0.001
72573391|NCT05958888|144673301|SUPERIORITY||Mean Difference (Final Values)|1.39|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|||||p-values were adjusted for multiple comparisons using the Bonferroni-Holm method, correcting for six tests within each outcome.The a priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Icon vs. Control||||<0.001
72573392|NCT05958888|144673301|SUPERIORITY||Mean Difference (Final Values)|1.62|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|||||p-values were adjusted for multiple comparisons using the Bonferroni-Holm method, correcting for six tests within each outcome. The a priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Graphic vs. Control||||<.001
72573393|NCT05958888|144673301|SUPERIORITY||Mean Difference (Final Values)|0.4|STANDARD_ERROR_OF_MEAN|0.2||0.1|TWO_SIDED|||||p-values were adjusted for multiple comparisons using the Bonferroni-Holm method, correcting for six tests within each outcome. The a priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Icon vs. Text||||.10
72573394|NCT05958888|144673301|SUPERIORITY||Mean Difference (Final Values)|0.63|STANDARD_ERROR_OF_MEAN|0.2||0.01|TWO_SIDED|||||p-values were adjusted for multiple comparisons using the Bonferroni-Holm method, correcting for six tests within each outcome. The a priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Graphic vs. Text||||.01
72573395|NCT05958888|144673301|SUPERIORITY||Mean Difference (Final Values)|0.23|STANDARD_ERROR_OF_MEAN|0.2||0.25|TWO_SIDED|||||p-values were adjusted for multiple comparisons using the Bonferroni-Holm method, correcting for six tests within each outcome. The a priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Graphic vs. Icon||||.25
72573396|NCT05958888|144673302|SUPERIORITY||Mean Difference (Final Values)|4.0|STANDARD_ERROR_OF_MEAN|0.85|<|0.001|TWO_SIDED|||||p-values were adjusted for multiple comparisons using the Bonferroni-Holm method, correcting for six tests within each outcome. The a priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Text vs. Control||||<.001
72626747|NCT00867035|144782412|SUPERIORITY_OR_OTHER||||||<|0.01||95.0|||||Wilcoxon (Mann-Whitney)|||baseline to 2 hours||||<0.01
72409049|NCT04394351|144326534|SUPERIORITY||LS mean difference|-0.05||||0.2064|TWO_SIDED|95.0|-0.139|0.03||P-value is not adjusted for multiple comparisons|ANCOVA||CI was based on treatment difference (Dupilumab group vs. placebo) of the LS mean change using ANCOVA model with baseline measurement as covariate and the treatment, baseline weight group strata as fixed factors.|Part A: Dupilumab High Dose versus Part A: Pooled Placebo||0.030|-0.139|0.2064
72409050|NCT04394351|144326534|SUPERIORITY||LS mean difference|0.02||||0.6361|TWO_SIDED|95.0|-0.069|0.112||P-value is not adjusted for multiple comparisons|ANCOVA||CI was based on treatment difference (Dupilumab group vs. placebo) of the LS mean change using ANCOVA model with baseline measurement as covariate and the treatment, baseline weight group strata as fixed factors.|Part A: Dupilumab Low Dose versus Part A: Pooled Placebo||0.112|-0.069|0.6361
72536835|NCT03359473|144604384|OTHER||Mean Difference (Net)|4.53|||||TWO_SIDED|90.0|-1.3|10.36|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and Baseline leg press strength, with Day as the repeated factor.|||10.36|-1.30|
72536836|NCT03359473|144604384|OTHER||Mean Difference (Net)|7.8|||||TWO_SIDED|90.0|0.83|14.76|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and Baseline leg press strength, with Day as the repeated factor.|||14.76|0.83|
72536837|NCT03359473|144604385|OTHER||Mean Difference (Net)|16.71|||||TWO_SIDED|90.0|9.86|23.56|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and Baseline leg press strength, with Day as the repeated factor.|||23.56|9.86|
72536838|NCT03359473|144604385|OTHER||Mean Difference (Net)|5.35|||||TWO_SIDED|90.0|-4.09|14.78|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and Baseline leg press strength, with Day as the repeated factor.|||14.78|-4.09|
72536839|NCT03359473|144604386|OTHER||Mean Difference (Net)|5.17|||||TWO_SIDED|90.0|-4.67|15.01|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and Baseline leg press strength, with Day as the repeated factor.|||15.01|-4.67|
72536840|NCT03359473|144604386|OTHER||Mean Difference (Net)|7.02|||||TWO_SIDED|90.0|0.46|13.58|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and Baseline leg press strength, with Day as the repeated factor.|||13.58|0.46|
72536841|NCT03359473|144604387|OTHER||Mean Difference (Net)|5.9|||||TWO_SIDED|90.0|-1.4|13.2|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and Baseline leg press strength, with Day as the repeated factor.|||13.2|-1.4|
72536842|NCT03359473|144604387|OTHER||Mean Difference (Net)|13.5|||||TWO_SIDED|90.0|1.6|25.5|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and Baseline leg press strength, with Day as the repeated factor.|||25.5|1.6|
72369036|NCT01499277|144248036|SUPERIORITY_OR_OTHER||Risk Difference (RD)|1.71|||||TWO_SIDED|95.0|-6.21|10.39||||RD is the difference in favorable rates (Ceftaroline minus Vancomycin/Aztreonam).CI was calculated by unstratified Miettinen and Nurminen CI.|CI for risk difference was estimated by 95% using unstratified Miettinen and Nurminen CI.|||10.39|-6.21|
72536843|NCT03359473|144604388|OTHER||Mean Difference (Net)|20.7|||||TWO_SIDED|90.0|10.1|31.2|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and Baseline leg press strength, with Day as the repeated factor.|||31.2|10.1|
72536844|NCT03359473|144604388|OTHER||Mean Difference (Net)|7.3|||||TWO_SIDED|90.0|-11.1|25.8|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and Baseline leg press strength, with Day as the repeated factor.|||25.8|-11.1|
72536845|NCT03359473|144604389|OTHER||Mean Difference (Net)|8.0|||||TWO_SIDED|90.0|-2.5|18.4|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and Baseline leg press strength, with Day as the repeated factor.|||18.4|-2.5|
72409051|NCT04394351|144326535|SUPERIORITY||LS mean difference|0.13||||0.2086|TWO_SIDED|95.0|-0.072|0.33||P-value is not adjusted for multiple comparisons|ANCOVA||CI was based on treatment difference (Dupilumab group vs. placebo) of the LS mean change using ANCOVA model with baseline measurement as covariate and the treatment, baseline weight group strata as fixed factors.|Part A: Dupilumab High Dose versus Part A: Pooled Placebo||0.330|-0.072|0.2086
72536846|NCT03359473|144604389|OTHER||Mean Difference (Net)|11.8|||||TWO_SIDED|90.0|-0.5|24.0|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and Baseline leg press strength, with Day as the repeated factor.|||24.0|-0.5|
72369037|NCT01499277|144248037|SUPERIORITY_OR_OTHER||Risk Difference (RD)|4.77|||||TWO_SIDED|95.0|-2.11|12.86||||RD is the difference in favorable rates (Ceftaroline minus Vancomycin/Aztreonam).CI was calculated by unstratified Miettinen and Nurminen CI.|CI for risk difference was estimated by 95% using unstratified Miettinen and Nurminen CI.|||12.86|-2.11|
72409052|NCT04394351|144326535|SUPERIORITY||LS mean difference|0.1||||0.2975|TWO_SIDED|95.0|-0.088|0.286||P-value is not adjusted for multiple comparisons|ANCOVA||CI was based on treatment difference (Dupilumab group vs. placebo) of the LS mean change using ANCOVA model with baseline measurement as covariate and the treatment, baseline weight group strata as fixed factors.|Part A: Dupilumab Low Dose versus Part A: Pooled Placebo||0.286|-0.088|0.2975
72409053|NCT04394351|144326536|SUPERIORITY||LS mean difference|-1.8||||0.2085|TWO_SIDED|95.0|-4.615|1.007||P-value is not adjusted for multiple comparisons|ANCOVA||CI was based on treatment difference (Dupilumab group vs. placebo) of the LS mean change using ANCOVA model with baseline measurement as covariate and the treatment, baseline weight group strata as fixed factors.|Part A: Dupilumab High Dose versus Part A: Pooled Placebo||1.007|-4.615|0.2085
72536847|NCT03359473|144604390|OTHER||Mean Difference (Net)|0.882|||||TWO_SIDED|90.0|0.643|1.121|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and Baseline appendicular lean mass, with Day as the repeated factor.|||1.121|0.643|
72536848|NCT03359473|144604390|OTHER||Mean Difference (Net)|0.291|||||TWO_SIDED|90.0|-0.156|0.738|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and Baseline appendicular lean mass, with Day as the repeated factor.|||0.738|-0.156|
72536849|NCT03359473|144604391|OTHER||Mean Difference (Net)|0.982|||||TWO_SIDED|90.0|0.629|1.334|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and Baseline appendicular lean mass, with Day as the repeated factor.|||1.334|0.629|
72626748|NCT00867035|144782412|SUPERIORITY_OR_OTHER||||||<|0.01||95.0|||||Wilcoxon (Mann-Whitney)|||baseline to 4 hours||||<0.01
72626749|NCT00867035|144782412|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Wilcoxon (Mann-Whitney)|||baseline to 1 week||||<0.05
72573397|NCT05958888|144673302|SUPERIORITY||Mean Difference (Final Values)|6.0|STANDARD_ERROR_OF_MEAN|0.85|<|0.001|TWO_SIDED|||||p-values were adjusted for multiple comparisons using the Bonferroni-Holm method, correcting for six tests within each outcome. The a priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Icon vs. Control||||<.001
72626750|NCT00867035|144782413|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||t-test, 2 sided|||Concentrations of H2S in mouth air at 1 hour analyzed between groups.||||>0.05
72626751|NCT00867035|144782414|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||t-test, 2 sided|||Concentrations of H2S in mouth air at 2 hours analyzed between groups. Each time point was compared between groups by Students t test.||||>0.05
72626752|NCT00867035|144782415|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||t-test, 2 sided|||Concentrations of H2S in mouth air at 4 hours analyzed between groups||||>0.05
72573398|NCT05958888|144673302|SUPERIORITY||Mean Difference (Final Values)|8.0|STANDARD_ERROR_OF_MEAN|0.85|<|0.001|TWO_SIDED|||||p-values were adjusted for multiple comparisons using the Bonferroni-Holm method, correcting for six tests within each outcome. The a priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Graphic vs. Control||||<.001
72573399|NCT05958888|144673302|SUPERIORITY||Mean Difference (Final Values)|1.0|STANDARD_ERROR_OF_MEAN|0.85||0.12|TWO_SIDED|||||p-values were adjusted for multiple comparisons using the Bonferroni-Holm method, correcting for six tests within each outcome. The a priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Icon vs. Text||||.12
72369038|NCT01499277|144248038|SUPERIORITY_OR_OTHER||Risk Difference (RD)|1.25|||||TWO_SIDED|95.0|-4.05|7.06||||RD is the difference in cure rates (Ceftaroline minus Vancomycin/Aztreonam).CI was calculated by unstratified Miettinen and Nurminen CI.|CI for risk difference was estimated by 95% using unstratified Miettinen and Nurminen CI.|||7.06|-4.05|
72409054|NCT04394351|144326536|SUPERIORITY||LS mean difference|-1.36||||0.3098|TWO_SIDED|95.0|-3.972|1.26||P-value is not adjusted for multiple comparisons|ANCOVA||CI was based on treatment difference (Dupilumab group vs. placebo) of the LS mean change using ANCOVA model with baseline measurement as covariate and the treatment, baseline weight group strata as fixed factors.|Part A: Dupilumab Low Dose versus Part A: Pooled Placebo||1.260|-3.972|0.3098
72573400|NCT05958888|144673302|SUPERIORITY||Mean Difference (Final Values)|3.0|STANDARD_ERROR_OF_MEAN|0.85|<|0.001|TWO_SIDED|||||p-values were adjusted for multiple comparisons using the Bonferroni-Holm method, correcting for six tests within each outcome. The a priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Graphic vs. Text||||<.001
72626753|NCT00867035|144782416|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||t-test, 2 sided|||Concentrations of H2S in mouth air at 1 week analyzed between groups. Each time point was compared between groups by Students t test.||||>0.05
72626754|NCT00867035|144782417|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||t-test, 2 sided|||Concentrations of MM in mouth air at 1 hour analyzed between groups||||>0.05
72626755|NCT00867035|144782418|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||t-test, 2 sided|||Concentrations of MM in mouth air at 2 hours analyzed between groups. Each time point was compared between groups by Students t test||||>0.05
72626756|NCT00867035|144782419|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||t-test, 2 sided|||Concentrations of MM in mouth air at 4 hours analyzed between groups. Each time point was compared between groups by Students t test.||||>0.05
72626757|NCT00867035|144782420|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||t-test, 2 sided|||Concentrtations of MM in mouth air at 1 week analyzed between groups. Each time point was compared between groups by Students t test||||>0.05
72626758|NCT00867035|144782421|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||t-test, 2 sided|||Counts of colony forming units from swab of 1square centimeter area on tongue at 1 week cultured on anaerobe plates for 1 week analyzed between groups||||>0.05
72626759|NCT00867035|144782422|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||t-test, 2 sided|||Percentage of black colonies out of Total Viable Count cultured on anaerobe agar with lead acetate. Black colonies are those producing sulfides (H2S, MM)and creating black lead sulfide. Analyzed between groups. Groups compared at baseline and 1 week.||||>0.05
72626760|NCT00404248|144782425|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.3||||0.9|ONE_SIDED||||||t-test, 2 sided|||||||0.9
72626761|NCT00404248|144782426|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|15.4||||0.6|TWO_SIDED||||||t-test, 2 sided|||||||0.6
72626762|NCT00404248|144782427|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.4||||0.8|TWO_SIDED||||||t-test, 2 sided|||||||0.8
72369039|NCT01499277|144248039|SUPERIORITY_OR_OTHER||Risk Difference (RD)|2.92|||||TWO_SIDED|95.0|-2.19|8.73||||RD is the difference in cure rates (Ceftaroline minus Vancomycin/Aztreonam).CI was calculated by unstratified Miettinen and Nurminen CI.|CI for risk difference was estimated by 95% using unstratified Miettinen and Nurminen CI.|||8.73|-2.19|
72573401|NCT05958888|144673302|SUPERIORITY||Mean Difference (Final Values)|2.0|STANDARD_ERROR_OF_MEAN|0.85||0.04|TWO_SIDED|||||p-values were adjusted for multiple comparisons using the Bonferroni-Holm method, correcting for six tests within each outcome. The a priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Graphic vs. Icon||||.04
72626763|NCT02581930|144782504|OTHER|Exact binomial test|Probability of response|0.0||||1|ONE_SIDED|||||Significant if p-value is less than 0.1|Exact binomial test, 1-sided||Estimated as proportion of subjects with response|The primary comparison was between the response rate of an ineffective drug, such as investigators' choice chemotherapy (5%), and the response rate of ibrutinib.||||1.00
72626764|NCT01170663|144782529|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.807||||0.0169|TWO_SIDED|95.0|0.678|0.962|||Stratified Log Rank Test|Adjusted for stratification factors: geographic region, time-to-progression from start of first-line therapy and disease measurability.||||0.962|0.678|0.0169
72626765|NCT01170663|144782530|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.635|||<|0.0001|TWO_SIDED|95.0|0.536|0.752|||Stratified Log Rank Test|Adjusted for stratification factors: geographic region, time-to-progression from start of first-line therapy and disease measurability.||||0.752|0.536|<0.0001
72626766|NCT01170663|144782531|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.596|||<|0.0001|TWO_SIDED|95.0|0.494|0.72|||Stratified Log Rank Test|Adjusted for stratification factors: geographic region, time-to-progression from start of first-line therapy and disease measurability.||||0.720|0.494|<0.0001
72536850|NCT03359473|144604391|OTHER||Mean Difference (Net)|1.127|||||TWO_SIDED|90.0|0.682|1.571|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and Baseline appendicular lean mass, with Day as the repeated factor.|||1.571|0.682|
72536851|NCT03359473|144604392|OTHER||Mean Difference (Net)|1.38|||||TWO_SIDED|90.0|0.964|1.795|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and Baseline appendicular lean mass, with Day as the repeated factor.|||1.795|0.964|
72536852|NCT03359473|144604392|OTHER||Mean Difference (Net)|1.124|||||TWO_SIDED|90.0|0.594|1.654|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and Baseline appendicular lean mass, with Day as the repeated factor.|||1.654|0.594|
72536853|NCT03359473|144604393|OTHER||Mean Difference (Net)|1.167|||||TWO_SIDED|90.0|0.677|1.658|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and Baseline total lean mass, with Day as the repeated factor.|||1.658|0.677|
72536854|NCT03359473|144604393|OTHER||Mean Difference (Net)|0.923|||||TWO_SIDED|90.0|0.222|1.623|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and Baseline total lean mass, with Day as the repeated factor.|||1.623|0.222|
72536855|NCT03359473|144604394|OTHER||Mean Difference (Net)|2.085|||||TWO_SIDED|90.0|1.493|2.678|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and Baseline total lean mass, with Day as the repeated factor.|||2.678|1.493|
72369040|NCT01499277|144248040|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.79|||||TWO_SIDED|95.0|-3.98|1.18||||RD is the difference in relapse rates (Ceftaroline minus Vancomycin/Aztreonam).CI was calculated by unstratified Miettinen and Nurminen CI.|CI for risk difference was estimated by 95% using unstratified Miettinen and Nurminen CI.|||1.18|-3.98|
72536856|NCT03359473|144604394|OTHER||Mean Difference (Net)|1.7|||||TWO_SIDED|90.0|0.801|2.6|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and Baseline total lean mass, with Day as the repeated factor.|||2.600|0.801|
72536857|NCT03359473|144604395|OTHER||Mean Difference (Net)|2.108|||||TWO_SIDED|90.0|1.271|2.945|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and Baseline total lean mass, with Day as the repeated factor.|||2.945|1.271|
72536858|NCT03359473|144604395|OTHER||Mean Difference (Net)|2.113|||||TWO_SIDED|90.0|0.949|3.277|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and Baseline total lean mass, with Day as the repeated factor.|||3.277|0.949|
72536859|NCT03359473|144604396|OTHER||Mean Difference (Net)|0.0|||||TWO_SIDED|90.0|-0.6|0.6|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and Baseline SPPB total score, with Day as the repeated factor.|||0.6|-0.6|
72536860|NCT03359473|144604396|OTHER||Mean Difference (Net)|0.0|||||TWO_SIDED|90.0|-0.4|0.5|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and Baseline SPPB total score, with Day as the repeated factor.|||0.5|-0.4|
72536861|NCT03359473|144604397|OTHER||Mean Difference (Net)|0.0|||||TWO_SIDED|90.0|-0.6|0.6|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and Baseline SPPB total score, with Day as the repeated factor.|||0.6|-0.6|
72536862|NCT03359473|144604397|OTHER||Mean Difference (Net)|0.3|||||TWO_SIDED|90.0|-0.2|0.9|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and Baseline SPPB total score, with Day as the repeated factor.|||0.9|-0.2|
72536863|NCT03359473|144604398|OTHER||Mean Difference (Net)|0.2|||||TWO_SIDED|90.0|-0.4|0.9|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and Baseline SPPB total score, with Day as the repeated factor.|||0.9|-0.4|
72536864|NCT03359473|144604398|OTHER||Mean Difference (Net)|0.1|||||TWO_SIDED|90.0|-0.5|0.6|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and Baseline SPPB total score, with Day as the repeated factor.|||0.6|-0.5|
72536865|NCT03359473|144604399|OTHER||Mean Difference (Net)|-0.553|||||TWO_SIDED|90.0|-2.082|0.977|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and corresponding Baseline time for chair rise, with Day as the repeated factor.|||0.977|-2.082|
72536866|NCT03359473|144604399|OTHER||Mean Difference (Net)|-0.073|||||TWO_SIDED|90.0|-0.977|0.832|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and corresponding Baseline time for chair rise, with Day as the repeated factor.|||0.832|-0.977|
72536867|NCT03359473|144604400|OTHER||Mean Difference (Net)|-0.816|||||TWO_SIDED|90.0|-2.252|0.619|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and corresponding Baseline time for chair rise, with Day as the repeated factor.|||0.619|-2.252|
72536868|NCT03359473|144604400|OTHER||Mean Difference (Net)|0.163|||||TWO_SIDED|90.0|-1.096|1.422|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and corresponding Baseline time for chair rise, with Day as the repeated factor.|||1.422|-1.096|
72369041|NCT01499277|144248041|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-1.86|||||TWO_SIDED|95.0|-6.34|3.15||||RD is the difference in success rates (Ceftaroline minus Vancomycin/Aztreonam).CI was calculated by unstratified Miettinen and Nurminen CI.|CI for risk difference was estimated by 95% using unstratified Miettinen and Nurminen CI.|||3.15|-6.34|
72536869|NCT03359473|144604401|OTHER||Mean Difference (Net)|-0.96|||||TWO_SIDED|90.0|-2.668|0.748|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and corresponding Baseline time for chair rise, with Day as the repeated factor.|||0.748|-2.668|
72536870|NCT03359473|144604401|OTHER||Mean Difference (Net)|-1.937|||||TWO_SIDED|90.0|-5.208|1.333|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and corresponding Baseline time for chair rise, with Day as the repeated factor.|||1.333|-5.208|
72536871|NCT03359473|144604402|OTHER||Mean Difference (Net)|-0.04|||||TWO_SIDED|90.0|-0.314|0.233|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and corresponding Baseline Time for fastest walk for 4 meter, with Day as the repeated factor.|||0.233|-0.314|
72536872|NCT03359473|144604402|OTHER||Mean Difference (Net)|0.058|||||TWO_SIDED|90.0|-0.209|0.324|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and corresponding Baseline Time for fastest walk for 4 meter, with Day as the repeated factor.|||0.324|-0.209|
72573402|NCT05958888|144673303|SUPERIORITY||Mean Difference (Final Values)|-0.56|STANDARD_ERROR_OF_MEAN|0.19||0.01|TWO_SIDED|||||p-values were adjusted for multiple comparisons using the Bonferroni-Holm method, correcting for six tests within each outcome. The a priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Text vs. Control||||.01
72369042|NCT04954833|144248058|NON_INFERIORITY|A non-inferiority margin of 0.05 logMAR. A value of 0.05 logMAR is approximately 2.5 letters on the ETDRS chart.|LS Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.006|||TWO_SIDED|95.0|-0.01|0.02|||Mixed Model Analysis|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.|LS Mean difference was calculated as Test - Control|||0.02|-0.01|
72409055|NCT04394351|144326537|SUPERIORITY||LS mean difference|0.07||||0.236|TWO_SIDED|95.0|-0.046|0.186||P-value is not adjusted for multiple comparisons|ANCOVA||CI was based on treatment difference (Dupilumab group vs. placebo) of the LS mean change using ANCOVA model with baseline measurement as covariate and the treatment, baseline weight group strata as fixed factors.|Part A: Dupilumab High Dose versus Part A: Pooled Placebo||0.186|-0.046|0.2360
72536873|NCT03359473|144604403|OTHER||Mean Difference (Net)|-0.287|||||TWO_SIDED|90.0|-0.65|0.077|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and corresponding Baseline Time for fastest walk for 4 meter, with Day as the repeated factor.|||0.077|-0.650|
72536874|NCT03359473|144604403|OTHER||Mean Difference (Net)|-0.191|||||TWO_SIDED|90.0|-0.534|0.152|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and corresponding Baseline Time for fastest walk for 4 meter, with Day as the repeated factor.|||0.152|-0.534|
72536875|NCT03359473|144604404|OTHER||Mean Difference (Net)|-0.012|||||TWO_SIDED|90.0|-0.555|0.532|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and corresponding Baseline Time for fastest walk for 4 meter, with Day as the repeated factor.|||0.532|-0.555|
72536876|NCT03359473|144604404|OTHER||Mean Difference (Net)|-0.231|||||TWO_SIDED|90.0|-0.541|0.08|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and corresponding Baseline Time for fastest walk for 4 meter, with Day as the repeated factor.|||0.080|-0.541|
72536877|NCT03359473|144604405|OTHER||Difference in Least Square Means|11.1|||||TWO_SIDED|90.0|-57.1|79.2|||||Analysis was performed by ANCOVA model with Baseline CWR duration as the covariate adjusting for the treatment.|||79.2|-57.1|
72536878|NCT03359473|144604405|OTHER||Difference in Least Square Means|-149.3|||||TWO_SIDED|90.0|-280.6|-18.1|||||Analysis was performed by ANCOVA model with Baseline CWR duration as the covariate adjusting for the treatment.|||-18.1|-280.6|
72536879|NCT03359473|144604406|OTHER||Difference in Least Square Means|-6.7|||||TWO_SIDED|90.0|-42.7|29.2|||||Analysis was performed by ANCOVA model with Baseline peak performance as the covariate adjusting for the treatment.|||29.2|-42.7|
72536880|NCT03359473|144604406|OTHER||Difference in Least Square Means|-34.8|||||TWO_SIDED|90.0|-72.0|2.4|||||Analysis was performed by ANCOVA model with Baseline peak performance as the covariate adjusting for the treatment.|||2.4|-72.0|
72536881|NCT03359473|144604407|OTHER||Mean Difference (Net)|-0.4|||||TWO_SIDED|90.0|-2.6|1.9|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and Baseline CAT score, with Day as the repeated factor.|||1.9|-2.6|
72536882|NCT03359473|144604407|OTHER||Mean Difference (Net)|-0.7|||||TWO_SIDED|90.0|-3.4|2.1|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and Baseline CAT score, with Day as the repeated factor.|||2.1|-3.4|
72536883|NCT03359473|144604408|OTHER||Mean Difference (Net)|-0.9|||||TWO_SIDED|90.0|-2.9|1.1|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and Baseline CAT score, with Day as the repeated factor.|||1.1|-2.9|
72536884|NCT03359473|144604408|OTHER||Mean Difference (Net)|2.2|||||TWO_SIDED|90.0|0.0|4.5|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and Baseline CAT score, with Day as the repeated factor.|||4.5|0.0|
72536885|NCT03359473|144604409|OTHER||Mean Difference (Net)|-4.7|||||TWO_SIDED|90.0|-8.9|-0.6|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and corresponding Baseline difficulty scores, with Day as the repeated factor.|||-0.6|-8.9|
72369043|NCT04954833|144248059|NON_INFERIORITY|A non-inferiority margin of 10% was used. A 10% of difference in the rate of lens fit acceptance is considered clinically significant.|Posterior mean difference of proportions|0.0|STANDARD_DEVIATION|0.0048|||TWO_SIDED|95.0|-0.009|0.01|||Bayesian hierarchical model|A 95% credible interval for the posterior mean difference between the Test and Control (Test - Control) was used to evaluate non-inferiority.|Interval presented is a 95% Credible interval|||0.010|-0.009|
72409056|NCT04394351|144326537|SUPERIORITY||LS mean difference|0.07||||0.1939|TWO_SIDED|95.0|-0.037|0.181||P-value is not adjusted for multiple comparisons|ANCOVA||CI was based on treatment difference (Dupilumab group vs. placebo) of the LS mean change using ANCOVA model with baseline measurement as covariate and the treatment, baseline weight group strata as fixed factors.|Part A: Dupilumab Low Dose versus Part A: Pooled Placebo||0.181|-0.037|0.1939
72536886|NCT03359473|144604409|OTHER||Mean Difference (Net)|-2.1|||||TWO_SIDED|90.0|-7.2|3.1|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and corresponding Baseline difficulty scores, with Day as the repeated factor.|||3.1|-7.2|
72536887|NCT03359473|144604410|OTHER||Mean Difference (Net)|-4.9|||||TWO_SIDED|90.0|-9.5|-0.4|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and corresponding Baseline difficulty scores, with Day as the repeated factor.|||-0.4|-9.5|
72536888|NCT03359473|144604410|OTHER||Mean Difference (Net)|-4.1|||||TWO_SIDED|90.0|-10.3|2.2|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and corresponding Baseline difficulty scores, with Day as the repeated factor.|||2.2|-10.3|
72536889|NCT03359473|144604411|OTHER||Mean Difference (Net)|-3.1|||||TWO_SIDED|90.0|-5.9|-0.3|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and corresponding Baseline amount scores, with Day as the repeated factor.|||-0.3|-5.9|
72536890|NCT03359473|144604411|OTHER||Mean Difference (Net)|-0.2|||||TWO_SIDED|90.0|-4.6|4.2|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and corresponding Baseline amount scores, with Day as the repeated factor.|||4.2|-4.6|
72536891|NCT03359473|144604412|OTHER||Mean Difference (Net)|4.0|||||TWO_SIDED|90.0|-0.8|8.8|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and corresponding Baseline amount scores, with Day as the repeated factor.|||8.8|-0.8|
72536892|NCT03359473|144604412|OTHER||Mean Difference (Net)|3.5|||||TWO_SIDED|90.0|-2.3|9.4|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and corresponding Baseline amount scores, with Day as the repeated factor.|||9.4|-2.3|
72536893|NCT03359473|144604413|OTHER||Mean Difference (Net)|-4.2|||||TWO_SIDED|90.0|-6.5|-1.9|||||Analysis was performed by mixed model repeated measures including the covariates; treatment, Day, treatment\*Day and corresponding Baseline total scores, with Day as the repeated factor.|||-1.9|-6.5|
72536894|NCT03359473|144604413|OTHER||Mean Difference (Net)|-1.5|||||TWO_SIDED|90.0|-4.1|1.1|||||Analysis was performed by mixed model repeated measures including the covariates; treatment, Day, treatment\*Day and corresponding Baseline total scores, with Day as the repeated factor.|||1.1|-4.1|
72536895|NCT03359473|144604414|OTHER||Mean Difference (Net)|-1.0|||||TWO_SIDED|90.0|-3.8|1.8|||||Analysis was performed by mixed model repeated measures including the covariates; treatment, Day, treatment\*Day and corresponding Baseline total scores, with Day as the repeated factor.|||1.8|-3.8|
72573403|NCT05958888|144673303|SUPERIORITY||Mean Difference (Final Values)|-0.35|STANDARD_ERROR_OF_MEAN|0.19||0.23|TWO_SIDED|||||p-values were adjusted for multiple comparisons using the Bonferroni-Holm method, correcting for six tests within each outcome. The a priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Icon vs. Control||||.23
72573404|NCT05958888|144673303|SUPERIORITY||Mean Difference (Final Values)|-0.59|STANDARD_ERROR_OF_MEAN|0.19||0.01|TWO_SIDED|||||p-values were adjusted for multiple comparisons using the Bonferroni-Holm method, correcting for six tests within each outcome. The a priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Graphic vs. Control||||.01
72573405|NCT05958888|144673303|SUPERIORITY||Mean Difference (Final Values)|0.21|STANDARD_ERROR_OF_MEAN|0.19||0.58|TWO_SIDED|||||p-values were adjusted for multiple comparisons using the Bonferroni-Holm method, correcting for six tests within each outcome. The a priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Icon vs. Text||||.58
72573406|NCT05958888|144673303|SUPERIORITY||Mean Difference (Final Values)|-0.03|STANDARD_ERROR_OF_MEAN|0.19||0.85|TWO_SIDED|||||p-values were adjusted for multiple comparisons using the Bonferroni-Holm method, correcting for six tests within each outcome. The a priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Graphic vs. Text||||.85
72573407|NCT05958888|144673303|SUPERIORITY||Mean Difference (Final Values)|-0.24|STANDARD_ERROR_OF_MEAN|0.19||0.58|TWO_SIDED|||||p-values were adjusted for multiple comparisons using the Bonferroni-Holm method, correcting for six tests within each outcome. The a priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Graphic vs. Icon||||.58
72573408|NCT05958888|144673304|SUPERIORITY||Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.1|>|0.99|TWO_SIDED|||||p-values were adjusted for multiple comparisons using the Bonferroni-Holm method, correcting for six tests within each outcome. The a priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Text vs. Control||||>.99
72573409|NCT05958888|144673304|SUPERIORITY||Mean Difference (Final Values)|-0.03|STANDARD_ERROR_OF_MEAN|0.1|>|0.99|TWO_SIDED|||||p-values were adjusted for multiple comparisons using the Bonferroni-Holm method, correcting for six tests within each outcome. The a priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Icon vs. Control||||>.99
72369044|NCT02688777|144248075|SUPERIORITY||Hazard Ratio, log|0.6|||||TWO_SIDED|||||||||||||
72536896|NCT03359473|144604414|OTHER||Mean Difference (Net)|-0.7|||||TWO_SIDED|90.0|-4.6|3.2|||||Analysis was performed by mixed model repeated measures including the covariates; treatment, Day, treatment\*Day and corresponding Baseline total scores, with Day as the repeated factor.|||3.2|-4.6|
72536897|NCT03359473|144604419|OTHER||Difference in Least Square Means|3.0|||||TWO_SIDED|90.0|-1.4|7.4|||||Analysis was performed by ANCOVA model with Baseline total score as the covariate adjusting for the treatment.|||7.4|-1.4|
72536898|NCT03359473|144604419|OTHER||Difference in Least Square Means|2.1|||||TWO_SIDED|90.0|-2.3|6.5|||||Analysis was performed by ANCOVA model with Baseline total score as the covariate adjusting for the treatment.|||6.5|-2.3|
72536899|NCT03359473|144604420|OTHER||Difference in Least Square Means|2.6|||||TWO_SIDED|90.0|-5.0|10.1|||||Analysis was performed by ANCOVA model with Baseline symptoms score as the covariate adjusting for the treatment.|||10.1|-5.0|
72573410|NCT05958888|144673304|SUPERIORITY||Mean Difference (Final Values)|-0.16|STANDARD_ERROR_OF_MEAN|0.1||0.47|TWO_SIDED|||||p-values were adjusted for multiple comparisons using the Bonferroni-Holm method, correcting for six tests within each outcome. The a priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Graphic vs. Control||||.47
72573411|NCT05958888|144673304|SUPERIORITY||Mean Difference (Final Values)|-0.04|STANDARD_ERROR_OF_MEAN|0.1|>|0.99|TWO_SIDED|||||p-values were adjusted for multiple comparisons using the Bonferroni-Holm method, correcting for six tests within each outcome. The a priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Icon vs. Text||||>.99
72369045|NCT02688777|144248076|SUPERIORITY||Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.03||0.37|TWO_SIDED|||||A priori threshold for significance is p \< 0.05.|t-test, 2 sided|||||||0.37
72369046|NCT02688777|144248077|SUPERIORITY||Mean Difference (Final Values)|0.16|STANDARD_ERROR_OF_MEAN|0.02||0.13|TWO_SIDED|||||A priori threshold set for p \< 0.05|t-test, 2 sided|||||||0.13
72536900|NCT03359473|144604420|OTHER||Difference in Least Square Means|-0.5|||||TWO_SIDED|90.0|-8.4|7.5|||||Analysis was performed by ANCOVA model with Baseline symptoms score as the covariate adjusting for the treatment.|||7.5|-8.4|
72536901|NCT03359473|144604421|OTHER||Difference in Least Square Means|2.0|||||TWO_SIDED|90.0|-3.2|7.1|||||Analysis was performed by ANCOVA model with Baseline activity score as the covariate adjusting for the treatment.|||7.1|-3.2|
72536902|NCT03359473|144604421|OTHER||Difference in Least Square Means|0.5|||||TWO_SIDED|90.0|-5.6|6.5|||||Analysis was performed by ANCOVA model with Baseline activity score as the covariate adjusting for the treatment.|||6.5|-5.6|
72536903|NCT03359473|144604422|OTHER||Difference in Least Square Means|3.4|||||TWO_SIDED|90.0|-1.7|8.6|||||Analysis was performed by ANCOVA model with Baseline impact score as the covariate adjusting for the treatment.|||8.6|-1.7|
72536904|NCT03359473|144604422|OTHER||Difference in Least Square Means|3.5|||||TWO_SIDED|90.0|-0.7|7.7|||||Analysis was performed by ANCOVA model with Baseline impact score as the covariate adjusting for the treatment.|||7.7|-0.7|
72369047|NCT02688777|144248078|SUPERIORITY||Mean Difference (Final Values)|0.8|STANDARD_ERROR_OF_MEAN|1.0||0.4|TWO_SIDED|||||A priori threshold p \< 0.05 for statistical significance.|t-test, 2 sided|||||||0.40
72369048|NCT02688777|144248079|SUPERIORITY||Mean Difference (Final Values)|5.7|STANDARD_ERROR_OF_MEAN|3.4||0.12|TWO_SIDED||||||t-test, 2 sided|||||||0.12
72536905|NCT05302414|144604427|SUPERIORITY||Median Difference (Final Values)|12.75|||<|0.05|TWO_SIDED||||||Kruskal-Wallis|||For the pretest at week 0.||||<0.05
72536906|NCT05302414|144604427|SUPERIORITY||Median Difference (Final Values)|2.0||||0.05|TWO_SIDED||||||Kruskal-Wallis|||For posttest right after intervention at the 4 weeks.||||0.05
72536907|NCT05302414|144604427|SUPERIORITY||Median Difference (Final Values)|6.0||||0.05|TWO_SIDED||||||Kruskal-Wallis|||For follow-up test at the 16 weeks.||||0.05
72536908|NCT05302414|144604428|SUPERIORITY||Median Difference (Final Values)|1.0|||<|0.05|TWO_SIDED||||||Kruskal-Wallis|||For pretest at the 0 week||||<0.05
72536909|NCT05302414|144604428|SUPERIORITY||Median Difference (Final Values)|0.0||||0.05|TWO_SIDED||||||Kruskal-Wallis|||For posttest right after intervention at the 4 weeks.||||0.05
72536910|NCT05302414|144604428|SUPERIORITY||Median Difference (Final Values)|0.0||||0.05|TWO_SIDED||||||Kruskal-Wallis|||For follow-up test at the 16 weeks.||||0.05
72536911|NCT05302414|144604429|SUPERIORITY||Median Difference (Final Values)|40.0|||<|0.05|TWO_SIDED||||||Kruskal-Wallis|||For the pretest at week 0.||||<0.05
72536912|NCT05302414|144604429|SUPERIORITY||Median Difference (Final Values)|45.0||||0.05|TWO_SIDED||||||Kruskal-Wallis|||For posttest right after intervention at the 4 weeks.||||0.05
72536913|NCT05302414|144604429|SUPERIORITY||Median Difference (Final Values)|43.0||||0.05|TWO_SIDED||||||Kruskal-Wallis|||For follow-up test at the 16 weeks.||||0.05
72536914|NCT05302414|144604430|SUPERIORITY||Median Difference (Final Values)|0.0|||<|0.05|TWO_SIDED||||||Kruskal-Wallis|||For the pretest at week 0.||||<0.05
72536915|NCT05302414|144604430|SUPERIORITY||Median Difference (Final Values)|0.0||||0.05|TWO_SIDED||||||Kruskal-Wallis|||For posttest right after intervention at the 4 weeks.||||0.05
72536916|NCT05302414|144604430|SUPERIORITY||Median Difference (Final Values)|2.5||||0.05|TWO_SIDED||||||Kruskal-Wallis|||For follow-up test at the 16 weeks.||||0.05
72536917|NCT05302414|144604431|SUPERIORITY||Median Difference (Final Values)|6.75|||<|0.05|TWO_SIDED||||||Kruskal-Wallis|||For the pretest at week 0.||||<0.05
72536918|NCT05302414|144604431|SUPERIORITY||Median Difference (Final Values)|0.25||||0.05|TWO_SIDED||||||Kruskal-Wallis|||For posttest right after intervention at the 4 weeks.||||0.05
72536919|NCT05302414|144604431|SUPERIORITY||Median Difference (Final Values)|0.0||||0.05|TWO_SIDED||||||Kruskal-Wallis|||For follow-up test at the 16 weeks.||||0.05
72536920|NCT05302414|144604432|SUPERIORITY||Median Difference (Final Values)|22.0|||<|0.05|TWO_SIDED||||||Kruskal-Wallis|||For posttest right after intervention at the 4 weeks.||||<0.05
72573412|NCT05958888|144673304|SUPERIORITY||Mean Difference (Final Values)|-0.17|STANDARD_ERROR_OF_MEAN|0.1||0.45|TWO_SIDED|||||p-values were adjusted for multiple comparisons using the Bonferroni-Holm method, correcting for six tests within each outcome. The a priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Graphic vs. Text||||.45
72573413|NCT05958888|144673304|SUPERIORITY||Mean Difference (Final Values)|-0.13|STANDARD_ERROR_OF_MEAN|0.1||0.7|TWO_SIDED|||||p-values were adjusted for multiple comparisons using the Bonferroni-Holm method, correcting for six tests within each outcome. The a priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Graphic vs. Icon||||.70
72573414|NCT05958888|144673305|SUPERIORITY||Mean Difference (Final Values)|0.89|STANDARD_ERROR_OF_MEAN|0.17|<|0.001|TWO_SIDED|||||p-values were adjusted for multiple comparisons using the Bonferroni-Holm method, correcting for six tests within each outcome. The a priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Text vs. Control||||<.001
72573415|NCT05958888|144673305|SUPERIORITY||Mean Difference (Final Values)|1.76|STANDARD_ERROR_OF_MEAN|0.17|<|0.001|TWO_SIDED|||||p-values were adjusted for multiple comparisons using the Bonferroni-Holm method, correcting for six tests within each outcome. The a priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Icon vs. Control||||<.001
72573416|NCT05958888|144673305|SUPERIORITY||Mean Difference (Final Values)|1.7|STANDARD_ERROR_OF_MEAN|0.17|<|0.001|TWO_SIDED|||||p-values were adjusted for multiple comparisons using the Bonferroni-Holm method, correcting for six tests within each outcome. The a priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Graphic vs. Control||||<.001
72573417|NCT05958888|144673305|SUPERIORITY||Mean Difference (Final Values)|0.87|STANDARD_ERROR_OF_MEAN|0.17|<|0.001|TWO_SIDED|||||p-values were adjusted for multiple comparisons using the Bonferroni-Holm method, correcting for six tests within each outcome. The a priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Icon vs. Text||||<.001
72573418|NCT05958888|144673305|SUPERIORITY||Mean Difference (Final Values)|0.81|STANDARD_ERROR_OF_MEAN|0.17|<|0.001|TWO_SIDED|||||p-values were adjusted for multiple comparisons using the Bonferroni-Holm method, correcting for six tests within each outcome. The a priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Graphic vs. Text||||<.001
72573419|NCT05958888|144673305|SUPERIORITY||Mean Difference (Final Values)|-0.06|STANDARD_ERROR_OF_MEAN|0.17||0.72|TWO_SIDED|||||p-values were adjusted for multiple comparisons using the Bonferroni-Holm method, correcting for six tests within each outcome. The a priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Graphic vs. Icon||||.72
72573420|NCT05958888|144673306|SUPERIORITY||Mean Difference (Final Values)|1.73|STANDARD_ERROR_OF_MEAN|0.14|<|0.001|TWO_SIDED|||||p-values were adjusted for multiple comparisons using the Bonferroni-Holm method, correcting for six tests within each outcome. The a priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Text vs. Control||||<.001
72573421|NCT05958888|144673306|SUPERIORITY||Mean Difference (Final Values)|2.39|STANDARD_ERROR_OF_MEAN|0.14|<|0.001|TWO_SIDED|||||p-values were adjusted for multiple comparisons using the Bonferroni-Holm method, correcting for six tests within each outcome. The a priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Icon vs. Control||||<.001
72573422|NCT05958888|144673306|SUPERIORITY||Mean Difference (Final Values)|2.11|STANDARD_ERROR_OF_MEAN|0.14|<|0.001|TWO_SIDED|||||p-values were adjusted for multiple comparisons using the Bonferroni-Holm method, correcting for six tests within each outcome. The a priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Graphic vs. Control||||<.001
72409057|NCT00812812|144326642|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.6||||0.198|TWO_SIDED|95.0|-11.7|2.5|||ANCOVA||Mean difference was estimated as paroxetine minus placebo.|||2.5|-11.7|0.198
72409058|NCT03091751|144326647|OTHER||Mean Difference (Final Values)|10.41||||0.77|TWO_SIDED|95.0|-224.88|245.7|||t-test, 1 sided|||||245.70|-224.88|0.77
72409059|NCT03091751|144326648|OTHER||Mean Difference (Final Values)|0.3068||||0.002|TWO_SIDED|95.0|0.1501|0.4635|||t-test, 1 sided|||||0.4635|0.1501|0.002
72409060|NCT03091751|144326649|OTHER||Mean Difference (Final Values)|-3.3||||0.3|TWO_SIDED|95.0|-8.9|2.3|||t-test, 1 sided|||||2.3|-8.9|0.30
72536921|NCT01102972|144604433|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority would be established between the two arms if the lower limit of the 2-sided 95% confidence interval (CI) for the difference in the percentage of participants with HIV-1 RNA \<50 copies/mL at Week 24 was -12% or greater.|Treatment difference of proportions|0.33||||0.937||95.0|-7.97|8.64||The p-value was obtained from the Cochran-Mantel-Haenszel method stratified by initial antiretroviral regimen.|Cochran-Mantel-Haenszel||95% confidence intervals were calculated (using Mantel-Haenszel weight) stratified by initial antiretroviral regimen.|||8.64|-7.97|0.937
72536922|NCT00116207|144604506|SUPERIORITY_OR_OTHER|||||||0.32|TWO_SIDED|||||p values were computed using a general linear model (ANOVA) adjusted at baseline for age, sex, HbA1c.|ANOVA|||BASELINE||||0.32
72536923|NCT00116207|144604506|SUPERIORITY_OR_OTHER|||||||0.045|TWO_SIDED|||||p values were computed using a general linear model (ANOVA) adjusted at baseline for age, sex, HbA1c.|ANOVA|||24-MONTH||||0.045
72573423|NCT05958888|144673306|SUPERIORITY||Mean Difference (Final Values)|0.66|STANDARD_ERROR_OF_MEAN|0.14|<|0.001|TWO_SIDED|||||p-values were adjusted for multiple comparisons using the Bonferroni-Holm method, correcting for six tests within each outcome. The a priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Icon vs. Text||||<.001
72409061|NCT03091751|144326650|OTHER||Mean Difference (Final Values)|-0.0058||||0.16|TWO_SIDED|95.0|-0.0119|0.0003|||t-test, 1 sided|||||0.0003|-0.0119|0.16
72536924|NCT00116207|144604507|SUPERIORITY_OR_OTHER|||||||0.52|TWO_SIDED|||||p values were computed using a general linear model (ANOVA) adjusted at baseline for age, sex, HbA1c.|ANOVA|||BASELINE||||0.52
72573424|NCT05958888|144673306|SUPERIORITY||Mean Difference (Final Values)|0.38|STANDARD_ERROR_OF_MEAN|0.14||0.01|TWO_SIDED|||||p-values were adjusted for multiple comparisons using the Bonferroni-Holm method, correcting for six tests within each outcome. The a priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Graphic vs. Text||||.01
72573425|NCT05958888|144673306|SUPERIORITY||Mean Difference (Final Values)|-0.28|STANDARD_ERROR_OF_MEAN|0.14||0.04|TWO_SIDED|||||p-values were adjusted for multiple comparisons using the Bonferroni-Holm method, correcting for six tests within each outcome. The a priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Graphic vs. Icon||||.04
72626767|NCT01170663|144782533|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.14||||0.0001|TWO_SIDED|95.0|1.45|3.16|||Cochran-Mantel-Haenszel|Adjusted for stratification factors: geographic region, time-to-progression from the start of first-line therapy and disease measurability.||||3.16|1.45|0.0001
72626768|NCT01170663|144782541|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3973||||||Analysis of covariance (ANCOVA) included treatment group, randomization stratification factors and baseline value of Global Health Status scale.|ANCOVA|||||||0.3973
72626769|NCT02621892|144782548|SUPERIORITY||Risk Difference (RD)|8.31|||<|0.02|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.02
72626770|NCT02621892|144782550|SUPERIORITY||Risk Difference (RD)|10.86|||<|0.008|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.008
72409062|NCT03091751|144326651|OTHER||Mean Difference (Final Values)|-7.609||||0.02|TWO_SIDED|95.0|-13.344|-1.879|||t-test, 1 sided|||||-1.879|-13.344|0.02
72409063|NCT01161329|144326652|NON_INFERIORITY_OR_EQUIVALENCE|It was estimated that 128 individuals would be required for 80 % Power with a type I error of 5% to detect a 2-point difference in BBS with a standard deviation of +/- 4 points. Because of the slow recruitment and the statistically significant improvements observed in the primary outcome in the intervention group during an interim analysis the study was finalized with fewer participants than had been initially calculated.||||||0.001||||||The Bonferroni method was used to assess longitudinal Changes and correct for multiple comparisons, with significance set at p\<0.016 to minimize the risk for type I errors.|Wilcoxon (Mann-Whitney)|||Intention-to-treat analysis was performed to assess the effects on the outcome measures. Between-group differences for all outcome measures were analyzed using Mann-Whitney U-test.||||0.001
72409064|NCT01161329|144326653|SUPERIORITY_OR_OTHER|||||||0.09||||||The p-value for the man differnece in SPPB between grpoups att three months was 0.09|Wilcoxon (Mann-Whitney)|||||||0.09
72409065|NCT03402243|144326657|SUPERIORITY||Estimated mean ratio|1.38|||||TWO_SIDED|95.0|1.1|1.75|||||Baseline adjusted model estimated mean ratio in cigarettes smoked per day of those randomized to a total menthol ban smoked relative to those randomized to a menthol cigarette ban|||1.75|1.1|
72409066|NCT03402243|144326657|SUPERIORITY||Estimated mean ratio|0.87|||||TWO_SIDED|95.0|0.68|1.11|||||Baseline adjusted model estimated mean ratio in cigarettes smoked per day of those randomized to a menthol cigarettes ban relative to those randomized to no menthol ban|||1.11|0.68|
72409067|NCT03402243|144326657|SUPERIORITY||Estimated mean ratio|1.2|||||TWO_SIDED|95.0|0.99|1.45|||||Baseline adjusted model estimated mean ratio in cigarettes smoked per day of those randomized to a menthol ban for cigarettes and e-cigarettes relative to those randomized to no menthol ban|||1.45|0.99|
72409068|NCT03402243|144326657|SUPERIORITY|||||||0.349|||||||Kruskal-Wallis|||Average number of puffs per participants over the 6 week study period||||0.349
72536925|NCT00116207|144604507|SUPERIORITY_OR_OTHER|||||||0.82|TWO_SIDED|||||p values were computed using a general linear model (ANOVA) adjusted at baseline for age, sex, HbA1c.|ANOVA|||24 MONTH||||0.82
72409069|NCT03402243|144326658|SUPERIORITY|||||||0.185|||||||Mixed Models Analysis|||Comparison among groups in number of cigarette packs selected||||0.185
72409070|NCT03402243|144326658|SUPERIORITY|||||||0.076|||||||Mixed Models Analysis|||Comparison among groups in number of e-cigarette liquid units selected||||0.076
72409071|NCT03402243|144326659|SUPERIORITY|||||||0.27|||||||Mixed Models Analysis|||||||0.27
72409072|NCT00684424|144326666|SUPERIORITY_OR_OTHER_LEGACY||R-ratio|-56.723|STANDARD_DEVIATION|46.9499||||95.0|||||summary statistic|||R-ratio of seizure frequency summaries = \[(t-b)/(t+b)\]\*100; where t= treatment seizure frequency and b= baseline seizure frequency.||||
72536926|NCT00116207|144604508|SUPERIORITY_OR_OTHER|||||||0.24|TWO_SIDED|||||p values were computed using a general linear model adjusted at baseline for age, sex, HbA1c.|ANOVA|||24 MONTH||||0.24
72536927|NCT00116207|144604509|SUPERIORITY_OR_OTHER|||||||0.83|TWO_SIDED|||||p values were computed using a general linear model (ANOVA) adjusted at baseline for age, sex, HbA1c.|ANOVA|||24 MONTH||||0.83
72536928|NCT00728988|144604510|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.0||||0.9237|TWO_SIDED|95.0|-7.3|9.3|||Chi-squared, Corrected||95% confidence interval for the true difference in the incidence of MACE between the two treatment groups. Difference of incidence = usual care minus atorvastatin.|Total MACE: treatment difference. Null hypothesis = no difference between the incidence rates in the two groups. A 5% two-sided continuity adjusted Chi-square test was applied.||9.3|-7.3|0.9237
72536929|NCT00728988|144604510|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0||||1|TWO_SIDED|95.0|-10.7|10.7|||Fisher Exact||Confidence limits were calculated by the exact unconditional inference. Difference of incidence = usual care minus atorvastatin.|Death: treatment difference. Null hypothesis = no difference between the incidence rates in two groups. Fisher's exact test was applied because the expected frequency of events was less than 5.||10.7|-10.7|1.0000
72536930|NCT00728988|144604510|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.0||||0.9158|TWO_SIDED|95.0|-7.2|9.2|||Chi-squared, Corrected||Difference of incidence = usual care minus atorvastatin.|Myocardial Infarction: treatment difference. Null hypothesis = no difference between the incidence rates in the two groups. A 5% two-sided continuity adjusted Chi-square test was applied.||9.2|-7.2|0.9158
72536931|NCT00728988|144604510|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.93||||0.8|TWO_SIDED|95.0|0.5104|1.6846|||Regression, Logistic|||Unadjusted odds ratio and 95% confidence interval calculated by including treatment group as the only covariate in the logistic regression model. Reference group = usual care.||1.6846|0.5104|0.80
72536932|NCT00728988|144604510|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.96||||0.9|TWO_SIDED|95.0|0.4887|1.8836|||Regression, Logistic|||Adjusted odds ratio: model includes treatment group and potential confounding covariates age, gender, country, non-ST elevation myocardial infarction, LVEF \<=40, and use of beta-blockers, ACE-inhibitors, angiotension receptor blockers, calcium channel antagonists, and diuretics. Reference group = usual care.||1.8836|0.4887|0.90
72536933|NCT00728988|144604510|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8494|TWO_SIDED||||||Log Rank|Survival analysis: Kaplan-Meier log rank test.||MACE-free survival up to Day 30. A censoring variable with a value of 1 denoted that the subject had the event and 0 indicated that the subject was censored. A log-rank test was applied to investigate any differences on the survival distribution function between two treatment groups.||||0.8494
72536934|NCT00728988|144604511|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.4||||1|TWO_SIDED|95.0|-5.6|6.3|||Chi-squared, Corrected||Difference of incidence = atorvastatin minus usual care.|Treatment difference (%). Null hypothesis = no difference between the incidence rates in the two groups. A 5% two-sided continuity adjusted Chi-square test was applied.||6.3|-5.6|1.0000
72536935|NCT00728988|144604512|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.6||||0.7896|TWO_SIDED|95.0|-9.7|6.5|||Chi-squared, Corrected||Difference of incidence = atorvastatin minus usual care .|Treatment difference (%). Null hypothesis = no difference between the incidence rates in the two groups. A 5% two-sided continuity adjusted Chi-square test was applied.||6.5|-9.7|0.7896
72536936|NCT00728988|144604513|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.4||||0.631|TWO_SIDED|95.0|-10.1|5.4|||Chi-squared, Corrected|||8 hours post-PCI: difference (%) in proportions. Null hypothesis = no difference in proportions of the two groups. A 5% two-sided continuity adjusted Chi-square test was applied.||5.4|-10.1|0.631
72573426|NCT05958888|144673307|SUPERIORITY||Mean Difference (Final Values)|0.59|STANDARD_ERROR_OF_MEAN|0.15|<|0.001|TWO_SIDED|||||p-values were adjusted for multiple comparisons using the Bonferroni-Holm method, correcting for six tests within each outcome. The a priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Text vs. Control||||<.001
72573427|NCT05958888|144673307|SUPERIORITY||Mean Difference (Final Values)|0.81|STANDARD_ERROR_OF_MEAN|0.15|<|0.001|TWO_SIDED|||||p-values were adjusted for multiple comparisons using the Bonferroni-Holm method, correcting for six tests within each outcome. The a priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Icon vs. Control||||<.001
72573428|NCT05958888|144673307|SUPERIORITY||Mean Difference (Final Values)|0.71|STANDARD_ERROR_OF_MEAN|0.15|<|0.001|TWO_SIDED|||||p-values were adjusted for multiple comparisons using the Bonferroni-Holm method, correcting for six tests within each outcome. The a priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Graphic vs. Control||||<.001
72626771|NCT02621892|144782551|SUPERIORITY||Risk Difference (RD)|10.34|||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
72626772|NCT02621892|144782552|SUPERIORITY||Risk Difference (RD)|11.92|||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
72369049|NCT02688777|144248080|SUPERIORITY||Mean Difference (Final Values)|0.03|STANDARD_ERROR_OF_MEAN|1.1||0.43|TWO_SIDED|||||A priori threshold set at p \< 0.05 for statistical significance.|t-test, 2 sided|||||||0.43
72369050|NCT02688777|144248081|SUPERIORITY||Mean Difference (Final Values)|2.2|STANDARD_ERROR_OF_MEAN|0.8||0.02|TWO_SIDED|||||A prior threshold for significance set at p \< 0.05|t-test, 2 sided|||||||0.02
72369051|NCT02688777|144248082|SUPERIORITY||Mean Difference (Final Values)|13.95|STANDARD_ERROR_OF_MEAN|8.9||0.28|TWO_SIDED||||||t-test, 2 sided|||||||0.28
72369052|NCT02688777|144248083|SUPERIORITY||Mean Difference (Final Values)|0.04||||0.22|TWO_SIDED||||||t-test, 2 sided|||||||0.22
72369053|NCT02688777|144248084|SUPERIORITY|||||||0.1|||||||t-test, 2 sided|||||||0.10
72369054|NCT02688777|144248085|SUPERIORITY|||||||0.09|||||||t-test, 2 sided|||||||0.09
72369055|NCT02688777|144248086|SUPERIORITY|||||||0.11|||||||t-test, 2 sided|||||||0.11
72536937|NCT00728988|144604513|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.3||||0.518|TWO_SIDED|95.0|-12.1|5.5|||Chi-squared, Corrected|||24 hours post-PCI: difference (%) in proportions. Null hypothesis = no difference in proportions of the two groups. A 5% two-sided continuity adjusted Chi-square test was applied.||5.5|-12.1|0.518
72536938|NCT00728988|144604513|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.3||||0.236|TWO_SIDED|95.0|-9.6|12.0|||Fisher Exact|||30 days post-PCI: difference (%) in proportions. Null hypothesis = no difference in proportions of the two groups. Fisher's exact test was applied because the expected frequency of biomarker elevation was less than 5.||12.0|-9.6|0.236
72626773|NCT02621892|144782553|SUPERIORITY||Risk Difference (RD)|10.9|||<|0.003|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.003
72369056|NCT02688777|144248087|SUPERIORITY|||||||0.28|||||||t-test, 2 sided|||||||0.28
72626774|NCT01816295|144782583|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Chi-squared|||||||<0.001
72409073|NCT00727857|144326682|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.86|||<|0.0001||95.0|0.51|1.22|||ANCOVA||Mean Difference = Pioglitazone \& metformin - pioglitazone|One-way Analysis of Covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate. Least Squares (LS) mean change and LS mean of the treatment difference reported.||1.22|0.51|<0.0001
72626775|NCT01816295|144782584|SUPERIORITY_OR_OTHER||Mean Difference (Net)|5.1|STANDARD_ERROR_OF_MEAN|1.42|<|0.001|TWO_SIDED|99.5|1.05|9.07|||ANCOVA|||||9.07|1.05|<0.001
72626776|NCT01816295|144782585|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.9|STANDARD_ERROR_OF_MEAN|1.25||0.019|TWO_SIDED|99.5|-0.59|6.45|||ANCOVA|||||6.45|-0.59|0.019
72626777|NCT01816295|144782586|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.34||0.442|TWO_SIDED|95.0|-0.94|0.41|||ANCOVA|||Change from Baseline to Week 12||0.41|-0.94|0.442
72369057|NCT02549365|144248088|OTHER||Odds Ratio (OR)|2.89|||||TWO_SIDED|95.0|0.6|13.9|||||Incidence of laboratory confirmed influenza is compared between those vaccinated and household controls. VE will be calculated as 1 - RR with 95% confidence intervals using Poisson regression.|||13.9|0.6|
72369058|NCT01075685|144248116|SUPERIORITY_OR_OTHER|||||||0.0279||95.0|||||Type 3 tests of fixed effects|||||||0.0279
72369059|NCT01075685|144248117|SUPERIORITY_OR_OTHER|||||||0.0189||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0189
72536939|NCT00728988|144604514|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.9||||0.425|TWO_SIDED|95.0|-6.2|15.9|||Chi-squared, Corrected|||8 hours post-PCI: difference (%) in proportions. Null hypothesis = no difference in proportions of the two groups. A 5% two-sided continuity adjusted Chi-square test was applied.||15.9|-6.2|0.425
72536940|NCT00728988|144604514|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.3||||0.392|TWO_SIDED|95.0|-6.1|16.7|||Chi-squared, Corrected|||24 hours post-PCI: difference (%) in proportions. Null hypothesis = no difference in proportions of the two groups. A 5% two-sided continuity adjusted Chi-square test was applied.||16.7|-6.1|0.392
72536941|NCT00728988|144604514|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.1||||1|TWO_SIDED|95.0|-10.7|10.9|||Fisher Exact|||30 days post-PCI: difference (%) in proportions. Null hypothesis = no difference in proportions of the two groups. Fisher's exact test was applied because the expected frequency of biomarker elevation was less than 5.||10.9|-10.7|1.000
72369060|NCT01075685|144248118|SUPERIORITY_OR_OTHER|||||||0.009||95.0|||||Chi-squared|||||||0.009
72369061|NCT01075685|144248119|SUPERIORITY_OR_OTHER|||||||0.082||95.0|||||Chi-squared|||||||0.082
72536942|NCT00728988|144604515|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.7||||0.529|TWO_SIDED|95.0|-9.6|4.3|||Chi-squared, Corrected|||8 hours post-PCI: difference (%) in proportions. Null hypothesis = no difference in proportions of the two groups. A 5% two-sided continuity adjusted Chi-square test was applied.||4.3|-9.6|0.529
72536943|NCT00728988|144604515|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.1||||0.827|TWO_SIDED|95.0|-5.8|3.6|||Chi-squared, Corrected|||24 hours post-PCI: difference (%) in proportions. Null hypothesis = no difference in proportions of the two groups. A 5% two-sided continuity adjusted Chi-square test was applied.||3.6|-5.8|0.827
72536944|NCT00728988|144604515|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.7||||0.616|TWO_SIDED|95.0|-10.3|11.5|||Fisher Exact|||30 days post-PCI: difference (%) in proportions. Null hypothesis = no difference in proportions of the two groups. Fisher's exact test was applied because the expected frequency of biomarker elevation was less than 5.||11.5|-10.3|0.616
72536945|NCT00728988|144604516|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-29.53||||0.7554|TWO_SIDED|95.0|-215.87|156.81|||ANOVA|||8 hours post-PCI: difference (% change).||156.81|-215.87|0.7554
72536946|NCT00728988|144604516|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|50.58||||0.7436|TWO_SIDED|95.0|-253.42|354.58|||ANOVA|||24 hours post-PCI: difference (% change).||354.58|-253.42|0.7436
72536947|NCT00728988|144604516|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-58.22||||0.4741|TWO_SIDED|95.0|-218.12|101.68|||ANOVA|||30 days post-PCI: difference (% change).||101.68|-218.12|0.4741
72536948|NCT01984229|144604519|SUPERIORITY_OR_OTHER||Geometric Least Square Mean Ratio|118.0|||||TWO_SIDED|90.0|102.0|137.0|||||The reported values are percentages of geometric least square mean ratio.|Analysis of variance (ANOVA) was applied to the log-transformed PK parameter and then back transformed to provide geometric least square mean ratios (Period 3/Period 1) and confidence intervals (CIs).||137|102|
72536949|NCT01984229|144604520|SUPERIORITY_OR_OTHER||Geometric Least Square Mean Ratio|177.0|||||TWO_SIDED|90.0|159.0|198.0|||||The reported values are percentages of geometric least square mean ratio.|ANOVA was applied to the log-transformed PK parameter and then back transformed to provide geometric least square mean ratios (Period 3/Period 1) and CIs.||198|159|
72536950|NCT01984229|144604521|SUPERIORITY_OR_OTHER||Geometric Least Square Mean Ratio|175.0|||||TWO_SIDED|90.0|157.0|195.0|||||The reported values are percentages of geometric least square mean ratio.|ANOVA was applied to the log-transformed PK parameter and then back transformed to provide geometric least square mean ratios (Period 3/Period 1) and CIs.||195|157|
72536951|NCT01984229|144604525|SUPERIORITY_OR_OTHER||Geometric Least Square Mean Ratio|28.7|||||TWO_SIDED|90.0|23.1|35.5|||||The reported values are percentages of geometric least square mean ratio.|ANOVA was applied to the log-transformed PK parameter and then back transformed to provide geometric least square mean ratios (Period 3/Period 1) and CIs.||35.5|23.1|
72536952|NCT01984229|144604526|SUPERIORITY_OR_OTHER||Geometric Least Square Mean Ratio|66.2|||||TWO_SIDED|90.0|56.7|77.4|||||The reported values are percentages of geometric least square mean ratio.|ANOVA was applied to the log-transformed PK parameter and then back transformed to provide geometric least square mean ratios (Period 3/Period 1) and CIs.||77.4|56.7|
72536953|NCT01984229|144604527|SUPERIORITY_OR_OTHER||Geometric Least Square Mean Ratio|75.1|||||TWO_SIDED|90.0|64.4|87.7|||||The reported values are percentages of geometric least square mean ratio.|ANOVA was applied to the log-transformed PK parameter and then back transformed to provide geometric least square mean ratios (Period 3/Period 1) and CIs.||87.7|64.4|
72536954|NCT02325739|144604540|OTHER||RP2D|120.0|||||||||||||The estimation parameter and recommended Phase 2 dose level for FGF401 (single agent - fasted) is 120mg.|||||
72626778|NCT01816295|144782586|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.39||0.905|TWO_SIDED|95.0|-0.82|0.72|||ANCOVA|||Change from Baseline to Week 36||0.72|-0.82|0.905
72409074|NCT00727857|144326682|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.84|||<|0.0001||95.0|0.5|1.18|||ANCOVA||Mean Difference = Pioglitazone \& metformin - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||1.18|0.50|<0.0001
72536955|NCT02325739|144604540|OTHER||RP2D|120.0|||||||||||||The estimation parameter and recommended Phase 2 dose level for FGF401 (single agent - fed) is 120mg.|||||
72536956|NCT02325739|144604540|OTHER||RP2D|120.0|||||||||||||The estimation parameter and recommended Phase 2 dose level for FGF401 + PDR001 combination is for FGF401 120mg.|||||
72536957|NCT02325739|144604540|OTHER||RP2D|300.0|||||||||||||The estimation parameter and recommended Phase 2 dose level for FGF401 + PDR001 combination is for PDR001 300mg.|||||
72536958|NCT00111007|144604581|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.906||||0.492|TWO_SIDED|95.0|0.627|1.31|||log rank test|||||1.310|0.627|0.492
72536959|NCT00111007|144604582|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.996||||0.979|TWO_SIDED|95.0|0.744|1.333|||log rank test|||||1.333|0.744|0.979
72536960|NCT00111007|144604583|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.863||||0.331|TWO_SIDED|95.0|0.641|1.162|||log rank test|||||1.162|0.641|0.331
72536961|NCT00111007|144604584|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.398||||0.146|TWO_SIDED|95.0|0.11|1.437|||log rank test|||||1.437|0.110|0.146
72536962|NCT00111007|144604585|SUPERIORITY_OR_OTHER|||||||0.389||95.0|||||Fisher Exact|||||||0.389
72536963|NCT01275170|144604592|OTHER|Geometric mean ratio (GMR) \[Renal Impairment/Healthy Control\]|GMR|1.63|||||TWO_SIDED|90.0|1.12|2.39||||||||2.39|1.12|
72536964|NCT01275170|144604592|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|2.19|||||TWO_SIDED|90.0|1.51|3.18||||||||3.18|1.51|
72536965|NCT01275170|144604592|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|4.87|||||TWO_SIDED|90.0|3.37|7.04||||||||7.04|3.37|
72536966|NCT01275170|144604592|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|9.32|||||TWO_SIDED|90.0|6.45|13.46||||||||13.46|6.45|
72536967|NCT01275170|144604592|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|1.76|||||TWO_SIDED|90.0|1.2|2.58||||||||2.58|1.20|
72369062|NCT00531661|144248120|SUPERIORITY_OR_OTHER|||||||0.0002||95.0|||||Negative Binomial Regression|||||||0.0002
72536968|NCT01275170|144604593|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|1.1|||||TWO_SIDED|90.0|0.64|1.88||||||||1.88|0.64|
72536969|NCT01275170|144604593|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|1.04|||||TWO_SIDED|90.0|0.62|1.77||||||||1.77|0.62|
72536970|NCT01275170|144604593|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|1.3|||||TWO_SIDED|90.0|0.77|2.2||||||||2.20|0.77|
72536971|NCT01275170|144604593|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|2.34|||||TWO_SIDED|90.0|1.39|3.96||||||||3.96|1.39|
72536972|NCT01275170|144604593|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|0.85|||||TWO_SIDED|90.0|0.5|1.44||||||||1.44|0.50|
72536973|NCT01275170|144604594|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|0.61|||||TWO_SIDED|90.0|0.42|0.9||||||||0.90|0.42|
72536974|NCT01275170|144604594|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|0.46|||||TWO_SIDED|90.0|0.31|0.66||||||||0.66|0.31|
72536975|NCT01275170|144604594|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|0.21|||||TWO_SIDED|90.0|0.14|0.3||||||||0.30|0.14|
72536976|NCT01275170|144604594|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|0.11|||||TWO_SIDED|90.0|0.07|0.16||||||||0.16|0.07|
72369063|NCT00531661|144248121|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||exact test of binomial proportions|P-value from exact test of binomial proportions compared proportion of all implantation cases free from DSRC to OPC of 0.80.||"Analysis of DSRC was based on the following pre-specified objective performance criteria: the lower limit of the two-sided 95.2% confidence interval on the freedom from DSRC rate for all implantation cases was at least 80%. The statistical hypotheses were:~Null: (Freedom from device / system-related complications) ≤ 80%~Alternative: (Freedom from device / system-related complications) \> 80%"||||<0.0001
72536977|NCT01275170|144604594|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|0.57|||||TWO_SIDED|90.0|0.39|0.84||||||||0.84|0.39|
72536978|NCT01275170|144604595|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|0.99|||||TWO_SIDED|90.0|0.82|1.21||||||||1.21|0.82|
72536979|NCT01275170|144604595|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|1.01|||||TWO_SIDED|90.0|0.84|1.22||||||||1.22|0.84|
72536980|NCT01275170|144604595|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|0.9|||||TWO_SIDED|90.0|0.74|1.08||||||||1.08|0.74|
72536981|NCT01275170|144604595|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|0.96|||||TWO_SIDED|90.0|0.79|1.16||||||||1.16|0.79|
72536982|NCT01275170|144604595|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|3.28|||||TWO_SIDED|90.0|2.7|4.0||||||||4.00|2.70|
72536983|NCT01275170|144604598|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|1.41|||||TWO_SIDED|90.0|1.07|1.84||||||||1.84|1.07|
72536984|NCT01275170|144604598|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|1.53|||||TWO_SIDED|90.0|1.17|1.99||||||||1.99|1.17|
72536985|NCT01275170|144604598|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|2.51|||||TWO_SIDED|90.0|1.93|3.26||||||||3.26|1.93|
72536986|NCT01275170|144604598|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|3.1|||||TWO_SIDED|90.0|2.39|4.03||||||||4.03|2.39|
72536987|NCT01275170|144604598|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|0.99|||||TWO_SIDED|90.0|0.76|1.29||||||||1.29|0.76|
72536988|NCT01275170|144604599|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|1.15|||||TWO_SIDED|90.0|0.65|2.06||||||||2.06|0.65|
72536989|NCT01275170|144604599|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|1.07|||||TWO_SIDED|90.0|0.61|1.89||||||||1.89|0.61|
72536990|NCT01275170|144604599|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|1.32|||||TWO_SIDED|90.0|0.75|2.32||||||||2.32|0.75|
72536991|NCT01275170|144604599|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|2.46|||||TWO_SIDED|90.0|1.4|4.33||||||||4.33|1.40|
72536992|NCT01275170|144604599|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|0.86|||||TWO_SIDED|90.0|0.49|1.51||||||||1.51|0.49|
72536993|NCT01275170|144604600|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|0.71|||||TWO_SIDED|90.0|0.54|0.93||||||||0.93|0.54|
72536994|NCT01275170|144604600|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|0.65|||||TWO_SIDED|90.0|0.5|0.85||||||||0.85|0.50|
72536995|NCT01275170|144604600|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|0.4|||||TWO_SIDED|90.0|0.31|0.52||||||||0.52|0.31|
72536996|NCT01275170|144604600|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|0.32|||||TWO_SIDED|90.0|0.25|0.42||||||||0.42|0.25|
72536997|NCT01275170|144604600|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|1.01|||||TWO_SIDED|90.0|0.78|1.31||||||||1.31|0.78|
72536998|NCT01275170|144604601|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|0.81|||||TWO_SIDED|90.0|0.61|1.08||||||||1.08|0.61|
72626779|NCT04562116|144782601|OTHER||Ratio|94.59||||0.5789|TWO_SIDED|90.0|79.57|112.45||A linear mixed-effect model was used to compare the natural log-transformed of the value, with substrate with or without Nemolizumab as the fixed effect and subject as a random effect.|Mixed Models Analysis|||Caffeine||112.45|79.57|0.5789
72369064|NCT00531661|144248122|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||exact test of binomial proportions|P-value from exact test of binomial proportions compared proportion of all implanted patients free from pressure sensor failure to OPC of 0.90.||"Analysis of sensor failures was based on the following pre-specified objective performance criteria: the lower limit of the two-sided 95.2% confidence interval on the freedom from pressure sensor failure rate for all patients implanted was at least 90%. The statistical hypotheses were:~Null: (Freedom from device / system-related complications) ≤ 90%~Alternative: (Freedom from device / system-related complications) \> 90%"||||<0.0001
72409075|NCT00727857|144326682|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02||||0.8919||95.0|-0.37|0.33|||ANCOVA||Mean Difference = Pioglitazone - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||0.33|-0.37|0.8919
72409076|NCT00727857|144326683|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|17.8||||0.0005||95.0|7.8|27.7|||ANCOVA||Mean Difference = Pioglitazone \& metformin - pioglitazone|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||27.7|7.8|0.0005
72536999|NCT01275170|144604601|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|0.95|||||TWO_SIDED|90.0|0.72|1.26||||||||1.26|0.72|
72537000|NCT01275170|144604601|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|0.8|||||TWO_SIDED|90.0|0.61|1.06||||||||1.06|0.61|
72537001|NCT01275170|144604601|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|0.83|||||TWO_SIDED|90.0|0.63|1.09||||||||1.09|0.63|
72537002|NCT01275170|144604601|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|2.54|||||TWO_SIDED|90.0|1.93|3.36||||||||3.36|1.93|
72537003|NCT01275170|144604604|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|1.6|||||TWO_SIDED|90.0|1.03|2.49||||||||2.49|1.03|
72537004|NCT01275170|144604604|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|1.86|||||TWO_SIDED|90.0|1.21|2.87||||||||2.87|1.21|
72537005|NCT01275170|144604604|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|5.6|||||TWO_SIDED|90.0|3.64|8.59||||||||8.59|3.64|
72537006|NCT01275170|144604604|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|13.75|||||TWO_SIDED|90.0|8.96|21.12||||||||21.12|8.96|
72537007|NCT01275170|144604604|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|3.64|||||TWO_SIDED|90.0|2.32|5.69||||||||5.69|2.32|
72369065|NCT00531661|144248123|SUPERIORITY_OR_OTHER|||||||0.0077||95.0|||||ANCOVA|||||||0.0077
72537008|NCT01275170|144604605|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|1.25|||||TWO_SIDED|90.0|0.75|2.08||||||||2.08|0.75|
72537009|NCT01275170|144604605|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|1.13|||||TWO_SIDED|90.0|0.69|1.87||||||||1.87|0.69|
72537010|NCT01275170|144604605|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|1.49|||||TWO_SIDED|90.0|0.9|2.44||||||||2.44|0.90|
72537011|NCT01275170|144604605|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|2.49|||||TWO_SIDED|90.0|1.51|4.09||||||||4.09|1.51|
72626780|NCT04562116|144782601|OTHER||Ratio|99.34||||0.9468|TWO_SIDED|90.0|83.66|117.96||A linear mixed-effect model was used to compare the natural log-transformed of the value, with substrate with or without Nemolizumab as the fixed effect and subject as a random effect.|Mixed Models Analysis|||Metoprolol Tartrate||117.96|83.66|0.9468
72409077|NCT00727857|144326683|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|15.1||||0.0021||95.0|5.5|24.7|||ANCOVA||Mean Difference = Pioglitazone \& metformin - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||24.7|5.5|0.0021
72409078|NCT00727857|144326683|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.6||||0.5981||95.0|-12.5|7.2|||ANCOVA||Mean Difference = Pioglitazone - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||7.2|-12.5|0.5981
72409079|NCT00727857|144326684|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.73||||0.5074||95.0|-1.43|2.88|||ANCOVA||Mean Difference = Pioglitazone \& metformin - pioglitazone|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||2.88|-1.43|0.5074
72537012|NCT01275170|144604605|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|0.94|||||TWO_SIDED|90.0|0.57|1.54||||||||1.54|0.57|
72537013|NCT01275170|144604606|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|0.63|||||TWO_SIDED|90.0|0.4|0.97||||||||0.97|0.40|
72537014|NCT01275170|144604606|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|0.54|||||TWO_SIDED|90.0|0.35|0.83||||||||0.83|0.35|
72537015|NCT01275170|144604606|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|0.18|||||TWO_SIDED|90.0|0.12|0.27||||||||0.27|0.12|
72537016|NCT01275170|144604606|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|0.07|||||TWO_SIDED|90.0|0.05|0.11||||||||0.11|0.05|
72537017|NCT01275170|144604606|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|0.27|||||TWO_SIDED|90.0|0.18|0.43||||||||0.43|0.18|
72537018|NCT01275170|144604607|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|0.8|||||TWO_SIDED|90.0|0.62|1.04||||||||1.04|0.62|
72537019|NCT01275170|144604607|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|0.91|||||TWO_SIDED|90.0|0.71|1.17||||||||1.17|0.71|
72537020|NCT01275170|144604607|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|0.8|||||TWO_SIDED|90.0|0.62|1.03||||||||1.03|0.62|
72537021|NCT01275170|144604607|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|0.76|||||TWO_SIDED|90.0|0.59|0.97||||||||0.97|0.59|
72537022|NCT01275170|144604607|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|2.81|||||TWO_SIDED|90.0|2.16|3.65||||||||3.65|2.16|
72537023|NCT01275170|144604613|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|1.52|||||TWO_SIDED|90.0|1.07|2.15||||||||2.15|1.07|
72537024|NCT01275170|144604613|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|0.63|||||TWO_SIDED|90.0|0.45|0.9||||||||0.90|0.45|
72537025|NCT01275170|144604613|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|0.67|||||TWO_SIDED|90.0|0.47|0.94||||||||0.94|0.47|
72537026|NCT01275170|144604614|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|1.07|||||TWO_SIDED|90.0|0.63|1.83||||||||1.83|0.63|
72537027|NCT01275170|144604614|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|0.6|||||TWO_SIDED|90.0|0.35|1.01||||||||1.01|0.35|
72537028|NCT01275170|144604614|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|0.61|||||TWO_SIDED|90.0|0.36|1.04||||||||1.04|0.36|
72369066|NCT00531661|144248124|SUPERIORITY_OR_OTHER|||||||0.0292||95.0|||||Fisher Exact|||||||0.0292
72369067|NCT00531661|144248125|SUPERIORITY_OR_OTHER|||||||0.028||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0280
72537029|NCT01275170|144604615|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|1.47|||||TWO_SIDED|90.0|0.63|3.4||||||||3.40|0.63|
72537030|NCT01275170|144604615|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|0.91|||||TWO_SIDED|90.0|0.41|2.0||||||||2.00|0.41|
72537031|NCT01275170|144604615|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|0.81|||||TWO_SIDED|90.0|0.37|1.78||||||||1.78|0.37|
72537032|NCT02864953|144604620|SUPERIORITY||Odds Ratio (OR)|1.17|||=|0.415|TWO_SIDED|95.0|0.8|1.71||P-value was analyzed by ordinal logistic regression adjusting for covariates: region, and IRT stratification factors including rtPA usage (yes/no), thrombectomy usage (yes/no), use of ASPECTS for screening (yes/no), baseline NIHSS (\<=20 vs. \>20).|Regression, Logistic|||||1.71|0.80|=0.4150
72537033|NCT02864953|144604622|SUPERIORITY||Odds Ratio (OR)|1.07|||=|0.7413|TWO_SIDED|95.0|0.72|1.6||A logistic regression model was used to estimate an odds ratio (and 95% CI) of improvement on the mRS dichotomized as 0-4 vs. 5-6 at Day 90.|Regression, Logistic|||||1.60|0.72|=0.7413
72537034|NCT02864953|144604623|SUPERIORITY||Mean Difference (Final Values)|0.82|||=|0.1242|TWO_SIDED|95.0|-0.23|1.87||Analysis of Variance (ANOVA) was used to compare the two study arms to assess the treatment effects on midline shift.|ANOVA|||||1.87|-0.23|=0.1242
72537035|NCT03728257|144604625|SUPERIORITY|Change in average steps per day between baseline and 3 months was compared between the two groups.||||||0.8793||||||a priori threshold for statistical significance p \< 0.05|Wilcoxon (Mann-Whitney)|||||||0.8793
72537036|NCT03728257|144604626|SUPERIORITY|Change in average steps per day between baseline and 6 months was compared between the two groups.||||||0.9597||||||a priori threshold for statistical significance p \< 0.05|Wilcoxon (Mann-Whitney)|||||||0.9597
72537037|NCT03728257|144604627|SUPERIORITY|Change in Berg balance between baseline and 3 months was compared between the two groups.||||||0.3||||||a priori threshold for statistical significance p \< 0.05|Wilcoxon (Mann-Whitney)|||||||0.30
72537038|NCT03728257|144604628|SUPERIORITY|Change in Berg balance between baseline and 3 months was compared between the two groups.||||||0.81||||||a priori threshold for statistical significance p \< 0.05|Wilcoxon (Mann-Whitney)|||||||0.81
72537039|NCT03728257|144604629|SUPERIORITY|Change in 30 Second Sit-to-Stand Test between baseline and 3 months was compared between the two groups.||||||0.2262||||||a priori threshold for statistical significance is p \< 0.05|Wilcoxon (Mann-Whitney)|||||||0.2262
72537040|NCT03728257|144604630|SUPERIORITY|Change in 30 Second Sit-to-Stand Test between baseline and 6 months was compared between the two groups.||||||0.59||||||a priori threshold for statistical significance p \< 0.05|Wilcoxon (Mann-Whitney)|||||||0.59
72537041|NCT03728257|144604631|SUPERIORITY|Change in SGRQ between baseline and 3 months was compared between the two groups.||||||0.26||||||a priori threshold for statistical significance p \< 0.05|Wilcoxon (Mann-Whitney)|||||||0.26
72369068|NCT00531661|144248126|SUPERIORITY_OR_OTHER|||||||0.0236||95.0|||||t-test, 2 sided|||||||0.0236
72369069|NCT00531661|144248127|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Negative Binomial Regression|||||||<0.0001
72537042|NCT03728257|144604632|SUPERIORITY|Change in SGRQ between baseline and 6 months was compared between the two groups.||||||0.78||||||a priori threshold for statistical significance p \< 0.05|Wilcoxon (Mann-Whitney)|||||||0.78
72537043|NCT03728257|144604633|SUPERIORITY|Change in MVPA between baseline and 3 months was compared between the two groups.||||||0.7073||||||a priori threshold for statistical significance p \< 0.05|Wilcoxon (Mann-Whitney)|||||||0.7073
72537044|NCT03728257|144604634|SUPERIORITY|Change in MVPA between baseline and 6 months was compared between the two groups.||||||0.313||||||a priori threshold for statistical significance p \< 0.05|Wilcoxon (Mann-Whitney)|||||||0.313
72537045|NCT03728257|144604635|SUPERIORITY|Change in count of participants with the same or improved stage of hypertension between baseline and 6 months.||||||0.91||||||a priori threshold for statistical significance p \< 0.05|Chi-squared|||||||0.91
72537046|NCT03728257|144604636|SUPERIORITY|Change in count of participants with the same or improved stage of hypertension between baseline and 6 months.||||||0.72||||||a priori threshold of statistical significance p \< 0.05|Chi-squared|||||||0.72
72537047|NCT02044094|144604817|NON_INFERIORITY|Blockade was achieved if the upper bound of the 95% confidence interval was \<= the non-inferiority margin of 11.|LSM difference|3.656|STANDARD_ERROR_OF_MEAN|1.85|||TWO_SIDED|95.0|-0.032|7.344|||||Hydromorphone - Placebo|"Week 1~Complete hydromorphone blockade was claimed for RBP-6000 if blockade was achieved for both hydromorphone doses (6 mg and 18 mg) during each week of testing for the 4 weeks after the first dose of RBP-6000. Each test was performed at a 2-sided α = 0.05."||7.344|-0.032|
72537048|NCT02044094|144604817|NON_INFERIORITY|Blockade was achieved if the upper bound of the 95% confidence interval was \<= the non-inferiority margin of 11.|LSM difference|6.927|STANDARD_ERROR_OF_MEAN|1.848|||TWO_SIDED|95.0|3.243|10.612|||||Hydromorphone - Placebo|Week 1 Complete hydromorphone blockade was claimed for RBP-6000 if blockade was achieved for both hydromorphone doses (6 mg and 18 mg) during each week of testing for the 4 weeks after the first dose of RBP-6000. Each test was performed at a 2-sided α = 0.05.||10.612|3.243|
72537049|NCT02044094|144604817|NON_INFERIORITY|Blockade was achieved if the upper bound of the 95% confidence interval was \<= the non-inferiority margin of 11.|LSM difference|0.586|STANDARD_ERROR_OF_MEAN|1.283|||TWO_SIDED|95.0|-1.977|3.149|||||Hydromorphone - Placebo|"Week 2~Complete hydromorphone blockade was claimed for RBP-6000 if blockade was achieved for both hydromorphone doses (6 mg and 18 mg) during each week of testing for the 4 weeks after the first dose of RBP-6000. Each test was performed at a 2-sided α = 0.05."||3.149|-1.977|
72537050|NCT02044094|144604817|NON_INFERIORITY|Blockade was achieved if the upper bound of the 95% confidence interval was \<= the non-inferiority margin of 11.|LSM difference|2.899|STANDARD_ERROR_OF_MEAN|1.285|||TWO_SIDED|95.0|0.333|5.465|||||Hydromorphone - Placebo|"Week 2~Complete hydromorphone blockade was claimed for RBP-6000 if blockade was achieved for both hydromorphone doses (6 mg and 18 mg) during each week of testing for the 4 weeks after the first dose of RBP-6000. Each test was performed at a 2-sided α = 0.05."||5.465|0.333|
72537051|NCT02044094|144604817|NON_INFERIORITY|Blockade was achieved if the upper bound of the 95% confidence interval was \<= the non-inferiority margin of 11.|LSM difference|0.863|STANDARD_ERROR_OF_MEAN|1.959|||TWO_SIDED|95.0|-3.053|4.778|||||Hydromorphone - Placebo|"Week 3~Complete hydromorphone blockade was claimed for RBP-6000 if blockade was achieved for both hydromorphone doses (6 mg and 18 mg) during each week of testing for the 4 weeks after the first dose of RBP-6000. Each test was performed at a 2-sided α = 0.05."||4.778|-3.053|
72537052|NCT02044094|144604817|NON_INFERIORITY|Blockade was achieved if the upper bound of the 95% confidence interval was \<= the non-inferiority margin of 11.|LSM difference|4.926|STANDARD_ERROR_OF_MEAN|1.956|||TWO_SIDED|95.0|1.016|8.837|||||Hydromorphone - Placebo|"Week 3~Complete hydromorphone blockade was claimed for RBP-6000 if blockade was achieved for both hydromorphone doses (6 mg and 18 mg) during each week of testing for the 4 weeks after the first dose of RBP-6000. Each test was performed at a 2-sided α = 0.05."||8.837|1.016|
72537053|NCT02044094|144604817|NON_INFERIORITY|Blockade was achieved if the upper bound of the 95% confidence interval was \<= the non-inferiority margin of 11.|LSM difference|3.316|STANDARD_ERROR_OF_MEAN|2.367|||TWO_SIDED|95.0|-1.425|8.025|||||Hydromorphone - Placebo|"Week 4~Complete hydromorphone blockade was claimed for RBP-6000 if blockade was achieved for both hydromorphone doses (6 mg and 18 mg) during each week of testing for the 4 weeks after the first dose of RBP-6000. Each test was performed at a 2-sided α = 0.05."||8.025|-1.425|
72537054|NCT02044094|144604817|NON_INFERIORITY|Blockade was achieved if the upper bound of the 95% confidence interval was \<= the non-inferiority margin of 11.|LSM difference|6.677|STANDARD_ERROR_OF_MEAN|2.367|||TWO_SIDED|95.0|1.936|11.418|||||Hydromorphone - Placebo|"Week 4~Complete hydromorphone blockade was claimed for RBP-6000 if blockade was achieved for both hydromorphone doses (6 mg and 18 mg) during each week of testing for the 4 weeks after the first dose of RBP-6000. Each test was performed at a 2-sided α = 0.05."||11.418|1.936|
72537055|NCT03353415|144604843|OTHER|||||||0.04|||||||Wilcoxon (Mann-Whitney)|||||||0.04
72537056|NCT03353415|144604844|OTHER|||||||0.03|||||||Wilcoxon (Mann-Whitney)|||||||0.03
72537057|NCT03353415|144604845|OTHER|||||||0.14|||||||Wilcoxon (Mann-Whitney)|||||||0.14
72537058|NCT03353415|144604846|OTHER|||||||0.45|||||||Wilcoxon (Mann-Whitney)|||||||0.45
72537059|NCT03353415|144604847|OTHER|||||||0.35|||||||Wilcoxon (Mann-Whitney)|||||||0.35
72537060|NCT03353415|144604848|OTHER|||||||0.53|||||||Wilcoxon (Mann-Whitney)|||||||0.53
72537061|NCT03353415|144604849|OTHER|||||||0.47|||||||Wilcoxon (Mann-Whitney)|||||||0.47
72537062|NCT03353415|144604850|OTHER|||||||0.65|||||||Wilcoxon (Mann-Whitney)|||||||0.65
72537063|NCT03353415|144604851|OTHER|||||||0.004|||||||Wilcoxon (Mann-Whitney)|||||||0.004
72537064|NCT03353415|144604852|OTHER|||||||0.05|||||||Wilcoxon (Mann-Whitney)|||||||0.05
72537065|NCT03353415|144604853|OTHER|||||||0.22|||||||Wilcoxon (Mann-Whitney)|||||||0.22
72537066|NCT03353415|144604854|OTHER|||||||0.09|||||||Wilcoxon (Mann-Whitney)|||||||0.09
72537067|NCT03353415|144604855|OTHER|||||||0.25|||||||Wilcoxon (Mann-Whitney)|||||||0.25
72537068|NCT03353415|144604856|OTHER|||||||0.04|||||||Wilcoxon (Mann-Whitney)|||||||0.04
72537069|NCT03353415|144604857|OTHER|||||||0.15|||||||Wilcoxon (Mann-Whitney)|||||||0.15
72537070|NCT03353415|144604858|OTHER|||||||0.03|||||||Wilcoxon (Mann-Whitney)|||||||0.03
72537071|NCT03353415|144604859|OTHER|||||||0.04|||||||Wilcoxon (Mann-Whitney)|||||||0.04
72537072|NCT03353415|144604860|OTHER|||||||0.32|||||||Wilcoxon (Mann-Whitney)|||||||0.32
72537073|NCT03353415|144604861|OTHER|||||||0.41|||||||Wilcoxon (Mann-Whitney)|||||||0.41
72537074|NCT03353415|144604862|OTHER|||||||0.04|||||||Wilcoxon (Mann-Whitney)|||||||0.04
72537075|NCT03353415|144604863|OTHER|||||||0.08|||||||Wilcoxon (Mann-Whitney)|||||||0.08
72537076|NCT03926728|144604880|OTHER|||||||1||||||Simple nonparametric statistical test.|Fisher Exact|||Comparison: Cohort A-C \[A1, A2, B1, B2, C1, C2\] vs D \[D1, D2\].||||1
72537077|NCT03926728|144604880|OTHER|||||||1||||||Simple nonparametric statistical test.|Fisher Exact|||Comparison: Cohort A-C \[A1, A2, B1, B2, C1, C2\] vs E \[E1, E2\].||||1
72537078|NCT03926728|144604880|OTHER|||||||0.0007|||||||Fisher Exact|||Comparison: Cohort A-C \[A1, A2, B1, B2, C1, C2\] vs F \[F1, F2\].||||0.0007
72537079|NCT03926728|144604883|OTHER|||||||1||||||Simple nonparametric statistical test.|Fisher Exact|||Comparison: Cohort B \[B1, B2\] vs A2.||||1
72537080|NCT03926728|144604883|OTHER|||||||0.3956|||||||Fisher Exact|||Comparison: Cohort B \[B1, B2\] vs F1.||||0.3956
72537081|NCT03926728|144604884|OTHER|||||||1||||||Simple nonparametric statistical test.|Fisher Exact|||Comparison: Cohort B \[B1, B2\] vs A2.||||1
72537082|NCT03926728|144604884|OTHER|||||||0.3956|||||||Fisher Exact|||Comparison: Cohort B \[B1, B2\] vs F1.||||0.3956
72537083|NCT03926728|144604886|OTHER|||||||1||||||Simple nonparametric statistical test.|Fisher Exact|||Comparison: Cohort A-C \[A1, A2, B1, B2, C1, C2\] vs D \[D1, D2\].||||1
72537084|NCT03926728|144604886|OTHER|||||||1||||||Simple nonparametric statistical test.|Fisher Exact|||Comparison: Cohort A-C \[A1, A2, B1, B2, C1, C2\] vs E \[E1, E2\].||||1
72537085|NCT03926728|144604886|OTHER|||||||0.3229|||||||Fisher Exact|||Comparison: Cohort A-C \[A1, A2, B1, B2, C1, C2\] vs F \[F1, F2\].||||0.3229
72537086|NCT00388674|144604922|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.93||||0.3553|TWO_SIDED|95.03|0.8|1.084|||Cox proportional hazards model||Hazard Ratio of ETV : Non-ETV Analyses are stratified by geographic region and prior HBV nucleoside/tide experience|||1.084|0.800|0.3553
72537087|NCT00388674|144604923|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.85||||0.0676|TWO_SIDED|95.03|0.713|1.012|||Cox proportional hazards model||Hazard Ratio of ETV : Non-ETV Analyses are stratified by geographic region and prior HBV nucleoside/tide experience|||1.012|0.713|0.0676
72537088|NCT00388674|144604924|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.89||||0.1182|TWO_SIDED|95.03|0.769|1.03|||Cox proportional hazards model||Hazard Ratio of ETV : Non-ETV Analyses are stratified by geographic region and prior HBV nucleoside/tide experience|||1.030|0.769|0.1182
72537089|NCT00388674|144604925|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.1|||||TWO_SIDED|95.0|0.817|1.478|||||Hazard Ratio of ETV : Non-ETV Analyses are stratified by geographic region and prior HBV nucleoside/tide experience|||1.478|0.817|
72573429|NCT05958888|144673307|SUPERIORITY||Mean Difference (Final Values)|0.22|STANDARD_ERROR_OF_MEAN|0.15||0.43|TWO_SIDED|||||p-values were adjusted for multiple comparisons using the Bonferroni-Holm method, correcting for six tests within each outcome. The a priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Icon vs. Text||||.43
72573430|NCT05958888|144673307|SUPERIORITY||Mean Difference (Final Values)|0.13|STANDARD_ERROR_OF_MEAN|0.15||0.81|TWO_SIDED|||||p-values were adjusted for multiple comparisons using the Bonferroni-Holm method, correcting for six tests within each outcome. The a priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Graphic vs. Text||||.81
72573431|NCT05958888|144673307|SUPERIORITY||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.15||0.81|TWO_SIDED|||||p-values were adjusted for multiple comparisons using the Bonferroni-Holm method, correcting for six tests within each outcome. The a priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Graphic vs. Icon||||.81
72573432|NCT03244644|144673313|SUPERIORITY||Treatment Difference|13.1|||||TWO_SIDED|95.0|2.3|24.0|||||The Bayesian posterior probability of superiority was 0.99136. This value exceeded the pre-specified threshold of 0.9750338 (nominal 0.025 one-sided level).|A hierarchical, closed-testing procedure (Bayesian hierarchical model) was utilized for the primary endpoint. The Bayesian hierarchical model formally incorporated data from the previous Phase 2B study (NCT02299570) of RBX2660. This analysis tested the hypothesis that the response rate of RBX2660 was superior to Placebo and was performed at the nominal 0.00125 and 0.025 one-sided levels.||24.0|2.3|
72573433|NCT03244644|144673314|SUPERIORITY|||||||0.156||||||P-value for secondary outcome evaluated from baseline through 6 months|Chi-squared|||||||0.156
72573434|NCT01007942|144673325|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.78||||0.0067|TWO_SIDED|95.0|0.65|0.95|||Log Rank|||||0.95|0.65|0.0067
72573435|NCT00806286|144673372|SUPERIORITY||Mean Difference (Final Values)|-23.2|||<|0.0001|TWO_SIDED|||||Two-sided p-value is calculated by dividing the square of the treatment group difference on the log-log scale by the standard error of the difference and referring the result to the standard normal distribution.|Z-test||The estimated value represents the difference in treatments (%).|||||<0.0001
72626781|NCT04562116|144782601|OTHER||Ratio|107.81||||0.1364|TWO_SIDED|90.0|99.14|117.24||A linear mixed-effect model was used to compare the natural log-transformed of the value, with substrate with or without Nemolizumab as the fixed effect and subject as a random effect.|Mixed Models Analysis|||Midazolam||117.24|99.14|0.1364
72537090|NCT00388674|144604926|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.87|||||TWO_SIDED|95.0|0.727|1.032|||||Hazard Ratio of ETV : Non-ETV Analyses are stratified by geographic region and prior HBV nucleoside/tide experience|||1.032|0.727|
72537091|NCT00388674|144604927|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.91|||||TWO_SIDED|95.0|0.608|1.365|||||Hazard Ratio of ETV : Non-ETV Analyses are stratified by geographic region and prior HBV nucleoside/tide experience|||1.365|0.608|
72537092|NCT00568776|144604928|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.03|STANDARD_ERROR_OF_MEAN|0.09||0.71|TWO_SIDED|95.0|-0.14|0.21|||Mixed Models Analysis|||||0.21|-0.14|0.71
72537093|NCT00568776|144604929|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.56|STANDARD_ERROR_OF_MEAN|1.9||0.18|TWO_SIDED|95.0|-6.33|1.22|||Mixed Models Analysis|||||1.22|-6.33|0.18
72626782|NCT04562116|144782601|OTHER||Ratio|92.13||||0.1915|TWO_SIDED|90.0|82.85|102.44||A linear mixed-effect model was used to compare the natural log-transformed of the value, with substrate with or without Nemolizumab as the fixed effect and subject as a random effect.|Mixed Models Analysis|||Omeprazole||102.44|82.85|0.1915
72626783|NCT04562116|144782601|OTHER||Ratio|101.67||||0.5059|TWO_SIDED|90.0|97.41|106.12||A linear mixed-effect model was used to compare the natural log-transformed of the value, with substrate with or without Nemolizumab as the fixed effect and subject as a random effect.|Mixed Models Analysis|||Warfarin Sodium||106.12|97.41|0.5059
72409080|NCT00727857|144326684|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.93||||0.0047||95.0|0.9|4.95|||ANCOVA||Mean Difference = Pioglitazone \& metformin - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||4.95|0.90|0.0047
72537094|NCT00568776|144604930|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.15|STANDARD_ERROR_OF_MEAN|0.11||0.17|TWO_SIDED|95.0|-0.06|0.36|||Mixed Models Analysis|||||0.36|-0.06|0.17
72537095|NCT00568776|144604931|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.39|STANDARD_ERROR_OF_MEAN|2.03||0.49|TWO_SIDED|95.0|-5.41|2.62|||Mixed Models Analysis|||||2.62|-5.41|0.49
72537096|NCT00568776|144604932|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.65|STANDARD_ERROR_OF_MEAN|2.2||0.77|TWO_SIDED|95.0|-3.73|5.03|||Mixed Models Analysis|||||5.03|-3.73|0.77
72537097|NCT00568776|144604933|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.29|STANDARD_ERROR_OF_MEAN|0.47||0.54|TWO_SIDED|95.0|-0.63|1.21|||Mixed Models Analysis|||||1.21|-0.63|0.54
72537098|NCT00568776|144604934|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.02|STANDARD_ERROR_OF_MEAN|2.24||0.65|TWO_SIDED|95.0|-3.43|5.46|||Mixed Models Analysis|||||5.46|-3.43|0.65
72537099|NCT02118896|144604968|SUPERIORITY_OR_OTHER_LEGACY||Kaplan-Meier Method|0.9257|||||TWO_SIDED|95.0|0.844|1.0||||||The two-sided 95% confidence interval for the estimated rate of freedom from BCAR at EOS was calculated using Greenwood's formula.||1.000|0.844|
72537100|NCT02118896|144604968|SUPERIORITY_OR_OTHER_LEGACY||Kaplan-Meier Method|0.9321|||||TWO_SIDED|95.0|0.858|1.0||||||The two-sided 95% confidence interval for the estimated rate of freedom from BCAR at EOS was calculated using Greenwood's formula.||1.000|0.858|
72573436|NCT00806286|144673372|SUPERIORITY||Cox Proportional Hazard|1.579||||0.0499|TWO_SIDED|95.0|1.0|2.5|||Regression, Cox|||||2.5|1.0|0.0499
72573437|NCT00806286|144673373|SUPERIORITY|Two-sided p-value is calculated by dividing the square of the treatment group difference on the log-log scale by the standard error of the difference and referring the result to the standard normal distribution.|Mean Difference (Final Values)|-25.5|||<|0.0001|TWO_SIDED||||||Z-test||The estimated value represents the difference in treatments (%).|||||<0.0001
72626784|NCT04562116|144782602|OTHER||Ratio|95.82||||0.6665|TWO_SIDED|90.0|80.72|113.75||A linear mixed-effect model was used to compare the natural log-transformed of the value, with substrate with or without Nemolizumab as the fixed effect and subject as a random effect.|Mixed Models Analysis|||Caffeine||113.75|80.72|0.6665
72573438|NCT03469336|144673382|OTHER|Ratio|Mean Ratio (Test/Reference)|1.0109|STANDARD_ERROR_OF_MEAN|0.732||0.9883|TWO_SIDED|95.0|0.2364|4.3226|||Mixed Models Analysis|||The efficacy assessment of PF-06763809 was performed for the change from baseline in log of the psoriatic skin infiltrate thickness/EPB on Day 19 using a longitudinal analysis of covariance model, with treatment, visit, treatment by visit interaction as main effects and the log of the psoriatic skin infiltrate thickness/EPB at baseline as covariate.||4.3226|0.2364|0.9883
72573439|NCT03469336|144673382|OTHER|Ratio|Mean Ratio (Test/Reference)|0.9979|STANDARD_ERROR_OF_MEAN|0.732||0.9977|TWO_SIDED|95.0|0.2334|4.2671|||Mixed Models Analysis|||The efficacy assessment of PF-06763809 was performed for the change from baseline in log of the psoriatic skin infiltrate thickness/EPB on Day 19 using a longitudinal analysis of covariance model, with treatment, visit, treatment by visit interaction as main effects and the log of the psoriatic skin infiltrate thickness/EPB at baseline as covariate.||4.2671|0.2334|0.9977
72573440|NCT03469336|144673382|OTHER|Ratio|Mean Ratio (Test/Reference)|1.1382|STANDARD_ERROR_OF_MEAN|0.732||0.86|TWO_SIDED|95.0|0.2662|4.867|||Mixed Models Analysis|||The efficacy assessment of PF-06763809 was performed for the change from baseline in log of the psoriatic skin infiltrate thickness/EPB on Day 19 using a longitudinal analysis of covariance model, with treatment, visit, treatment by visit interaction as main effects and the log of the psoriatic skin infiltrate thickness/EPB at baseline as covariate.||4.8670|0.2662|0.8600
72573441|NCT03469336|144673387|OTHER|Ratio|Mean Ratio (Test/Reference)|0.9979|STANDARD_ERROR_OF_MEAN|0.071||0.9763|TWO_SIDED|95.0|0.8588|1.1594|||Mixed Models Analysis|||To evaluate the AUC of psoriatic skin infiltrate thickness/EPB for PF-06763809 compared to vehicle.||1.1594|0.8588|0.9763
72573442|NCT03469336|144673387|OTHER|Ratio|Mean Ratio (Test/Reference)|0.9664|STANDARD_ERROR_OF_MEAN|0.051||0.5081|TWO_SIDED|95.0|0.8686|1.0752|||Mixed Models Analysis|||To evaluate the AUC of psoriatic skin infiltrate thickness/EPB for PF-06763809 compared to vehicle.||1.0752|0.8686|0.5081
72626785|NCT04562116|144782602|OTHER||Ratio|99.15||||0.9316|TWO_SIDED|90.0|83.43|117.83||A linear mixed-effect model was used to compare the natural log-transformed of the value, with substrate with or without Nemolizumab as the fixed effect and subject as a random effect.|Mixed Models Analysis|||Metoprolol Tartrate||117.83|83.43|0.9316
72369070|NCT00531661|144248128|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||exact test of binomial proportions|P-value from exact test of binomial proportions compared proportion of all implanted patients free from DSRC to OPC of 0.80.||"Analysis of DSRC was based on the following pre-specified objective performance criteria: the lower limit of the two-sided 95.2% confidence interval on the freedom from DSRC rate for all implanted patients was at least 80%. The statistical hypotheses were:~Null: (Freedom from device / system-related complications) ≤ 80%~Alternative: (Freedom from device / system-related complications) \> 80%"||||<0.0001
72626786|NCT04562116|144782602|OTHER||Ratio|107.75||||0.1371|TWO_SIDED|90.0|99.12|117.13||A linear mixed-effect model was used to compare the natural log-transformed of the value, with substrate with or without Nemolizumab as the fixed effect and subject as a random effect.|Mixed Models Analysis|||Midazolam||117.13|99.12|0.1371
72537101|NCT02118896|144604968|SUPERIORITY_OR_OTHER_LEGACY||Kaplan-Meier Method|1.0|||||TWO_SIDED|95.0|1.0|1.0||||||The two-sided 95% confidence interval for the estimated rate of freedom from BCAR at EOS was calculated using Greenwood's formula.||1.0000|1.0000|
72537102|NCT02118896|144604968|SUPERIORITY_OR_OTHER_LEGACY||Kaplan-Meier Method|0.8699|||||TWO_SIDED|95.0|0.79|0.949||||||The two-sided 95% confidence interval for the estimated rate of freedom from BCAR at EOS was calculated using Greenwood's formula.||0.949|0.790|
72537103|NCT02118896|144604968|SUPERIORITY_OR_OTHER_LEGACY||Kaplan-Meier Method|0.9607|||||TWO_SIDED|95.0|0.927|0.995||||||The two-sided 95% confidence interval for the estimated rate of freedom from BCAR at EOS was calculated using Greenwood's formula.||0.995|0.927|
72537104|NCT02118896|144604968|SUPERIORITY_OR_OTHER_LEGACY||Kaplan-Meier Method|0.9948|||||TWO_SIDED|95.0|0.985|1.0||||||The two-sided 95% confidence interval for the estimated rate of freedom from BCAR at EOS was calculated using Greenwood's formula.||1.000|0.985|
72537105|NCT02118896|144604968|SUPERIORITY_OR_OTHER_LEGACY||Kaplan-Meier Method|1.0|||||TWO_SIDED|95.0|1.0|1.0||||||The two-sided 95% confidence interval for the estimated rate of freedom from BCAR at EOS was calculated using Greenwood's formula.||1.0000|1.0000|
72537106|NCT02118896|144604968|SUPERIORITY_OR_OTHER_LEGACY||Kaplan-Meier Method|1.0|||||TWO_SIDED|95.0|1.0|1.0||||||The two-sided 95% confidence interval for the estimated rate of freedom from BCAR at EOS was calculated using Greenwood's formula.||1.0000|1.0000|
72537107|NCT02118896|144604968|SUPERIORITY_OR_OTHER_LEGACY||Kaplan-Meier Method|0.9773|||||TWO_SIDED|95.0|0.933|1.0||||||The two-sided 95% confidence interval for the estimated rate of freedom from BCAR at EOS was calculated using Greenwood's formula.||1.000|0.933|
72537108|NCT02118896|144604971|SUPERIORITY_OR_OTHER_LEGACY||Kaplan-Meier Method|0.8391|||||TWO_SIDED|95.0|0.729|0.949||||||The two-sided 95% confidence interval for the estimated rate of freedom from efficacy failure at EOS was calculated using Greenwood's formula.||0.949|0.729|
72537109|NCT02118896|144604971|SUPERIORITY_OR_OTHER_LEGACY||Kaplan-Meier Method|0.8792|||||TWO_SIDED|95.0|0.778|0.981||||||The two-sided 95% confidence interval for the estimated rate of freedom from efficacy failure at EOS was calculated using Greenwood's formula..||0.981|0.778|
72537110|NCT02118896|144604971|SUPERIORITY_OR_OTHER_LEGACY||Kaplan-Meier Method|0.8816|||||TWO_SIDED|95.0|0.782|0.981||||||The two-sided 95% confidence interval for the estimated rate of freedom from efficacy failure at EOS was calculated using Greenwood's formula.||0.981|0.782|
72537111|NCT02118896|144604971|SUPERIORITY_OR_OTHER_LEGACY||Kaplan-Meier Method|0.7769|||||TWO_SIDED|95.0|0.675|0.878||||||The two-sided 95% confidence interval for the estimated rate of freedom from efficacy failure at EOS was calculated using Greenwood's formula.||0.878|0.675|
72537112|NCT02118896|144604971|SUPERIORITY_OR_OTHER_LEGACY||Kaplan-Meier Method|0.8373|||||TWO_SIDED|95.0|0.693|0.981||||||The two-sided 95% confidence interval for the estimated rate of freedom from efficacy failure at EOS was calculated using Greenwood's formula.||0.981|0.693|
72573443|NCT03469336|144673387|OTHER|Ratio|Mean Ratio (Test/Reference)|1.1155|STANDARD_ERROR_OF_MEAN|0.044||0.0249|TWO_SIDED|95.0|1.0157|1.2252|||Mixed Models Analysis|||To evaluate the AUC of psoriatic skin infiltrate thickness/EPB for PF-06763809 compared to vehicle.||1.2252|1.0157|0.0249
72626787|NCT04562116|144782602|OTHER||Ratio|88.66||||0.0962|TWO_SIDED|90.0|78.72|99.85||A linear mixed-effect model was used to compare the natural log-transformed of the value, with substrate with or without Nemolizumab as the fixed effect and subject as a random effect.|Mixed Models Analysis|||Omeprazole||99.85|78.72|0.0962
72626788|NCT04562116|144782602|OTHER||Ratio|100.81||||0.6807|TWO_SIDED|90.0|97.45|104.29||A linear mixed-effect model was used to compare the natural log-transformed of the value, with substrate with or without Nemolizumab as the fixed effect and subject as a random effect.|Mixed Models Analysis|||Warfarin Sodium||104.29|97.45|0.6807
72626789|NCT04562116|144782603|OTHER||Ratio|91.22||||0.3431|TWO_SIDED|90.0|77.3|107.63||A linear mixed-effect model was used to compare the natural log-transformed of the value, with substrate with or without Nemolizumab as the fixed effect and subject as a random effect.|Mixed Models Analysis|||Caffeine||107.63|77.30|0.3431
72626790|NCT04562116|144782603|OTHER||Ratio|91.05||||0.4277|TWO_SIDED|90.0|74.33|111.53||A linear mixed-effect model was used to compare the natural log-transformed of the value, with substrate with or without Nemolizumab as the fixed effect and subject as a random effect.|Mixed Models Analysis|||Metoprolol Tartrate||111.53|74.33|0.4277
72626791|NCT04562116|144782603|OTHER||Ratio|94.79||||0.4963|TWO_SIDED|90.0|82.8|108.52||A linear mixed-effect model was used to compare the natural log-transformed of the value, with substrate with or without Nemolizumab as the fixed effect and subject as a random effect.|Mixed Models Analysis|||Midazolam||108.52|82.80|0.4963
72626792|NCT04562116|144782603|OTHER||Ratio|88.24||||0.1931|TWO_SIDED|90.0|75.08|103.7||A linear mixed-effect model was used to compare the natural log-transformed of the value, with substrate with or without Nemolizumab as the fixed effect and subject as a random effect.|Mixed Models Analysis|||Omeprazole||103.70|75.08|0.1931
72626793|NCT04562116|144782603|OTHER||Ratio|92.94||||0.296|TWO_SIDED|90.0|82.51|104.69||A linear mixed-effect model was used to compare the natural log-transformed of the value, with substrate with or without Nemolizumab as the fixed effect and subject as a random effect.|Mixed Models Analysis|||Warfarin Sodium||104.69|82.51|0.2960
72626794|NCT00934921|144782614|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Ratio of Geometric Means|97.1||||||90.0|91.2|103.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||103|91.2|
72626795|NCT00934921|144782615|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Ratio of Geometric Means|95.2||||||90.0|88.8|102.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||102|88.8|
72626796|NCT00934921|144782616|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Ratio of Geometric Means|95.9||||||90.0|89.5|103.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||103|89.5|
72626797|NCT03781479|144782617|OTHER||Mean Difference (Net)|0.792||||0.0083|TWO_SIDED|95.0|0.22|1.37|||Mixed Models Analysis||Results show the LSMeans for the estimated difference between treatments along with a 95% confidence interval for this difference.|A mixed effects liner model was fit with the HFMSE change from baseline (CFB) scores at Day 28 as a response and treatment, sequence, and treatment by sequence as fixed effect terms and patient as a random effect.||1.37|0.22|0.0083
72626798|NCT02921256|144782618|SUPERIORITY|||||||0.69|||||||Regression, Linear|||||||0.69
72626799|NCT02921256|144782618|SUPERIORITY|||||||0.26|||||||Regression, Linear|||||||0.26
72626800|NCT04211363|144782649|SUPERIORITY||Odds Ratio (OR)|20.69|||<|0.0001|TWO_SIDED|95.0|7.58|56.48|||Cochran-Mantel-Haenszel|Stratified by pooled study site, baseline IGA, and baseline intertriginous involvement per randomization with multiple imputation of missing data.|Common odds ratio stratified by pooled study site, baseline IGA, and baseline intertriginous involvement per randomization with multiple imputation of missing data..|IGA Success Odds Ratio||56.48|7.58|<0.0001
72626801|NCT04211363|144782650|SUPERIORITY||Hazard Ratio (HR)|3.867|||<|0.0001|TWO_SIDED|95.0|2.795|5.351|||Log Rank|Unstratified log-rank test|Stratified by pooled study site, baseline IGA, and baseline intertriginous involvement per randomization.|Time to PASI-50||5.351|2.795|<0.0001
72626802|NCT04211363|144782651|SUPERIORITY||Odds Ratio (OR)|12.0|||<|0.0001|TWO_SIDED|95.0|5.15|27.93|||Cochran-Mantel-Haenszel|Stratified by pooled study site, baseline IGA, and baseline intertriginous involvement per randomization with multiple imputation of missing data.|Common odds ratio stratified by pooled study site, baseline IGA, and baseline intertriginous involvement per randomization with multiple imputation of missing data.|PASI-75 at Week 8 Odds Ratio||27.93|5.15|<0.0001
72626803|NCT04211363|144782652|SUPERIORITY||Odds Ratio (OR)|17.9|||<|0.0001|TWO_SIDED|95.0|4.38|73.09|||Cochran-Mantel-Haenszel|Stratified by study site, baseline IGA score, and baseline intertriginous involvement with multiple imputation of missing data.|Cochran-Mantel-Haenszel stratified by study site, baseline IGA score, and baseline intertriginous involvement with multiple imputation of missing data.|PASI-90 at Week 8 Odds Ratio||73.09|4.38|<0.0001
72626804|NCT04211363|144782653|SUPERIORITY||Odds Ratio (OR)|17.94|||<|0.0001|TWO_SIDED|95.0|2.33|138.2|||Cochran-Mantel-Haenszel|Stratified by pooled study site and baseline IGA per randomization with multiple imputation of missing data.|Common odds ratio stratified by pooled study site and baseline IGA per randomization with multiple imputation of missing data.|I-IGA Success at Week 8 Odds Ratio||138.20|2.33|<0.0001
72626805|NCT04211363|144782654|SUPERIORITY||Odds Ratio (OR)|29.36||||0.003|TWO_SIDED|95.0|2.99|288.36|||Cochran-Mantel-Haenszel|Stratified by pooled study site and baseline IGA per randomization with multiple imputation of missing data.|Common odds ratio stratified by pooled study site and baseline IGA per randomization with multiple imputation of missing data.|I-IGA Clear at Week 8 Odds Ratio||288.36|2.99|0.003
72626806|NCT04211363|144782655|SUPERIORITY||Odds Ratio (OR)|1.76||||0.1197|TWO_SIDED|95.0|0.98|3.19|||Cochran-Mantel-Haenszel|Stratified by pooled study site, baseline IGA, and baseline intertriginous involvement per randomization with multiple imputation of missing data.|Common odds ratio stratified by pooled study site, baseline IGA, and baseline intertriginous involvement per randomization with multiple imputation of missing data.|WI-NRS Success at Week 2 Odds Ratio||3.19|0.98|0.1197
72626807|NCT04211363|144782655|SUPERIORITY||Odds Ratio (OR)|4.36|||<|0.0001|TWO_SIDED|95.0|2.31|8.26|||Cochran-Mantel-Haenszel|Stratified by pooled study site, baseline IGA, and baseline intertriginous involvement per randomization with multiple imputation of missing data.|Common odds ratio stratified by pooled study site, baseline IGA, and baseline intertriginous involvement per randomization with multiple imputation of missing data.|WI-NRS Success at Week 4 Odds Ratio||8.26|2.31|<0.0001
72626808|NCT04211363|144782655|SUPERIORITY||Odds Ratio (OR)|7.84|||<|0.0001|TWO_SIDED|95.0|3.85|15.94|||Cochran-Mantel-Haenszel|Stratified by pooled study site, baseline IGA, and baseline intertriginous involvement per randomization with multiple imputation of missing data.|Common odds ratio stratified by pooled study site, baseline IGA, and baseline intertriginous involvement per randomization with multiple imputation of missing data.|WI-NRS at Week 8 Odds Ratio||15.94|3.85|<0.0001
72626809|NCT04211363|144782656|SUPERIORITY||Mean Difference (Final Values)|-25.83|||<|0.0001|TWO_SIDED|95.0|-31.7|-20.0|||ANCOVA|Site, baseline IGA, baseline intertriginous involvement, and baseline PSD scores were independent variables, multiple imputation used for missing data|Site, baseline IGA, baseline intertriginous involvement, and baseline PSD scores were independent variables, multiple imputation used for missing data|Comparison of change from baseline in PSD score at Week 4||-20.0|-31.7|<0.0001
72626810|NCT04211363|144782656|SUPERIORITY||Mean Difference (Final Values)|-30.9|||<|0.0001|TWO_SIDED|95.0|-37.2|-24.6|||ANCOVA|Site, baseline IGA, baseline intertriginous involvement, and baseline PSD scores were independent variables, multiple imputation used for missing data|Site, baseline IGA, baseline intertriginous involvement, and baseline PSD scores were independent variables, multiple imputation used for missing data|Comparison of change from baseline in PSD score at Week 8||-24.6|-37.2|<0.0001
72626811|NCT03097289|144782657|NON_INFERIORITY|"The acceptance criterion for the recovery (%) of platelets is the demonstration of non-inferiority by the rejection of the Null Hypothesis (H0) defined by the following hypotheses: Null Hypothesis H0: μd ≤ 0 where μd=μT-0.66\*μC Alternate Hypothesis H1: μd \>~Let Xi = (XTi-0.66\*XCi) be a difference if recovery for patient i. The sample mean and standard deviations of these observed differences will be used to construct the lower limit of a 1-sided 97.5% confidence interval."|Mean Difference (Final Values)|8.18|||||ONE_SIDED|97.5|4.03||||||||||4.03|
72537113|NCT02118896|144604971|SUPERIORITY_OR_OTHER_LEGACY||Kaplan-Meier Method|0.9419|||||TWO_SIDED|95.0|0.883|1.0||||||The two-sided 95% confidence interval for the estimated rate of freedom from efficacy failure at EOS was calculated using Greenwood's formula.||1.000|0.883|
72626812|NCT03097289|144782658|NON_INFERIORITY|"The acceptance criterion for the survival (days) of platelets is the demonstration of non inferiority by the rejection of the null hypothesis (H0) defined by the following hypotheses:~Null Hypothesis H0: μd ≤ 0 where μd = μT-0.58 × μC Alternate Hypothesis H1: μd \> 0"|Mean Difference (Final Values)|0.8|||||ONE_SIDED|97.5|0.39||||||||||0.39|
72626813|NCT01911260|144782666|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.12|STANDARD_DEVIATION|2.0|<|0.05|TWO_SIDED|95.0|||||t-test, 2 sided|In intragroup of supplementation (zinc or placebo) we used the t-test for dependent samples in order to compare growth over time.||"Null Hypothesis: There isn't difference in the HAZ mean difference between children with Growth Deficit who received zinc amino acid or placebo.~We attributed α=0.05, β=0.20, and power=0.80."||||<0.05
72626814|NCT01911260|144782666|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.08|STANDARD_DEVIATION|2.0|<|0.05|TWO_SIDED|95.0|||||t-test, 2 sided|In intragroup of supplementation (zinc or placebo) we used the t-test for dependent samples in order to compare growth over time.||"Null Hypothesis: There isn't difference in the HAZ mean difference between children with Normal Height who received zinc amino acid or placebo.~We attributed α=0.05, β=0.20, and power=0.80."||||<0.05
72537114|NCT02118896|144604971|SUPERIORITY_OR_OTHER_LEGACY||Kaplan-Meier Method|1.0|||||TWO_SIDED|95.0|1.0|1.0||||||The two-sided 95% confidence interval for the estimated rate of freedom from efficacy failure at EOS was calculated using Greenwood's formula.||1.000|1.000|
72537115|NCT02118896|144604971|SUPERIORITY_OR_OTHER_LEGACY||Kaplan-Meier Method|0.9898|||||TWO_SIDED|95.0|0.97|1.0||||||The two-sided 95% confidence interval for the estimated rate of freedom from efficacy failure at EOS was calculated using Greenwood's formula.||1.000|0.970|
72537116|NCT02118896|144604971|SUPERIORITY_OR_OTHER_LEGACY||Kaplan-Meier Method|0.9773|||||TWO_SIDED|95.0|0.933|1.0||||||The two-sided 95% confidence interval for the estimated rate of freedom from efficacy failure at EOS was calculated using Greenwood's formula.||1.000|0.933|
72537117|NCT03292731|144604972|OTHER||Odds Ratio (OR)|1.0||||0.96|TWO_SIDED|95.0|0.93|1.08||adjusted for cerclage|Regression, Logistic|adjusted for cerclage||logistic regression comparing drug concentration to the rate of sPTB||1.08|0.93|0.96
72537118|NCT03292731|144604973|OTHER||Slope|1.11||||0.05|TWO_SIDED|95.0|0.0|2.23|||Regression, Linear|||||2.23|0.00|0.05
72537119|NCT03292731|144604974|OTHER||Slope|1.56||||0.022|TWO_SIDED|95.0|0.25|2.87|||Regression, Linear|||||2.87|0.25|0.022
72537120|NCT03292731|144604975|SUPERIORITY|||||||0.82||||||no adjustments|Fisher Exact|||Only RCT subjects utilized in neonatal safety analysis||||0.82
72537121|NCT03901352|144604979|SUPERIORITY||Difference of LSM vs placebo|-0.71|STANDARD_ERROR_OF_MEAN|0.187||0.0001|TWO_SIDED|95.0|-1.08|-0.34|||ANCOVA||"The multiple imputation (MI) was based on a nonfuture dependence model using the pattern mixture model (PMM) approach with shifting parameters under the missing not at random (MNAR0 mechanism for the missing weekly ADPS."|||-0.34|-1.08|0.0001
72537122|NCT01965431|144604991|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin is the maximum acceptable extent of statistical and clinical noninferiority of an experimental treatment. Non-inferiority margin for this trial is 10ms.|Mean Difference (Net)|7.9|STANDARD_ERROR_OF_MEAN|1.52|||TWO_SIDED|90.0|5.37|10.43|||||Maximum mean difference to placebo is estimated. Adjusted means are based on a mixed model for repeated measures with 'global' \& 'period-global baseline' covariates. Toeplitz covariance model used for modelling the random and repeated effect.|||10.43|5.37|
72537123|NCT01965431|144604992|SUPERIORITY_OR_OTHER||Mean Difference (Net)|12.7|STANDARD_ERROR_OF_MEAN|2.02|||TWO_SIDED|90.0|9.32|16.08|||||Maximum mean difference to placebo is estimated. Adjusted means are based on a mixed model for repeated measures with 'global' \& 'period-global baseline' covariates. Toeplitz covariance model used for modelling the random and repeated effect.|No formal hypothesis testing was done.||16.08|9.32|
72537124|NCT01965431|144604993|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.17|STANDARD_ERROR_OF_MEAN|0.94|||TWO_SIDED|90.0|-1.38|1.73|||||Maximum mean difference to placebo is estimated. Adjusted means are based on a mixed model for repeated measures with 'global' \& 'period-global baseline' covariates. Toeplitz covariance model used for modelling the random and repeated effect.|No formal hypothesis testing was done.||1.73|-1.38|
72537125|NCT01965431|144604994|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.42|STANDARD_ERROR_OF_MEAN|0.94|||TWO_SIDED|90.0|-5.98|-2.87|||||Minimum mean difference to placebo is estimated. Adjusted means are based on a mixed model for repeated measures with 'global' \& 'period-global baseline' covariates. Toeplitz covariance model used for modelling the random and repeated effect.|No formal hypothesis testing was done.||-2.87|-5.98|
72626815|NCT01734902|144782670|EQUIVALENCE|The statistical model, analysis of variance (ANOVA) on the logarithmic scale includes effects: 'sequence', 'subjects within sequences', 'period', and 'treatment'. The effect 'subject within sequences' was considered as random, whereas the other effects were considered as fixed.|Adjusted gMean ratio T/R (%)|86.97|STANDARD_ERROR_OF_MEAN|35.6|||TWO_SIDED|90.0|74.046|102.151|||||Standard error of the mean is actually intra-individual geometric coefficient variance \[%\]. Statistical analysis is based on PKS which includes 27 subjects.|||102.151|74.046|
72626816|NCT01734902|144782671|EQUIVALENCE|The statistical model, analysis of variance (ANOVA) on the logarithmic scale includes effects: 'sequence', 'subjects within sequences', 'period', and 'treatment'. The effect 'subject within sequences' was considered as random, whereas the other effects were considered as fixed.|Adjusted gMean ratio T/R (%)|89.05|STANDARD_ERROR_OF_MEAN|31.2|||TWO_SIDED|90.0|77.26|102.62|||||Standard error of the mean is actually intra-individual geometric coefficient variance \[%\]. Statistical analysis is based on PKS which includes 27 subjects.|||102.62|77.26|
72626817|NCT01734902|144782672|EQUIVALENCE|The statistical model, analysis of variance (ANOVA) on the logarithmic scale includes effects: 'sequence', 'subjects within sequences', 'period', and 'treatment'. The effect 'subject within sequences' was considered as random, whereas the other effects were considered as fixed.|Adjusted gMean ratio T/R [%]|90.03|STANDARD_ERROR_OF_MEAN|29.3|||TWO_SIDED|90.0|78.78|102.88|||||Standard error of the mean is actually intra-individual geometric coefficient variance \[%\]. Statistical analysis is based on PKS which includes 27 subjects.|||102.88|78.78|
72626818|NCT01959932|144782673|SUPERIORITY_OR_OTHER_LEGACY||Geometric LS Mean Ratio|8.38|||<|0.001|TWO_SIDED|95.0|6.89|10.2||The primary endpoints were tested using a multiple testing procedure to preserve the overall alpha level by simultaneously testing the endpoints using a closed procedure with each test performed at an alpha level of 2.5% one sided.|ANCOVA|ANCOVA model on MHBMA levels with product, sex, cigarette consumption, and baseline value as covariates.|LS mean ratio THS 2.2:CC|"The hypothesis to be tested is that the geometric mean level on Day 5 of the biomarker of exposure for THS 2.2 is lower relative to CC.~Analysis of the BoExp was conducted on the natural log scale in order to test the following hypothesis (one sided test with 2.5% type I error probability):~* Null hypothesis (H0): m1≥m2~* Alternative hypothesis (H1): m1\<m2 Where m1 and m2 are the geometric means of the BoExp levels on Day 5 for THS 2.2 and CC respectively."||10.20|6.89|<0.001
72626819|NCT01959932|144782674|SUPERIORITY_OR_OTHER_LEGACY||Geometric LS mean ratio|41.63|||<|0.001|TWO_SIDED|95.0|37.75|45.91||The primary endpoints were tested using a multiple testing procedure to preserve the overall alpha level by simultaneously testing the endpoints using a closed procedure with each test performed at an alpha level of 2.5% one sided.|ANCOVA|ANCOVA model on 3-HPMA levels with product, sex, cigarette consumption, and baseline value as covariates.|LS mean ratio THS 2.2:CC|"The hypothesis to be tested is that the geometric mean level on Day 5 of the biomarker of exposure for THS 2.2 is lower relative to CC.~Analysis of the BoExp was conducted on the natural log scale in order to test the following hypothesis (one sided test with 2.5% type I error probability):~* Null hypothesis (H0): m1≥m2~* Alternative hypothesis (H1): m1\<m2 Where m1 and m2 are the geometric means of the BoExp levels on Day 5 for THS 2.2 and CC respectively."||45.91|37.75|<0.001
72626820|NCT01959932|144782675|SUPERIORITY_OR_OTHER_LEGACY||Geometric LS Mean Ratio|5.99|||<|0.001|TWO_SIDED|95.0|5.21|6.87||The primary endpoints were tested using a multiple testing procedure to preserve the overall alpha level by simultaneously testing the endpoints using a closed procedure with each test performed at an alpha level of 2.5% one sided.|ANCOVA|ANCOVA model on S-PMA levels with product, sex, cigarette consumption, and baseline value as covariates.|LS mean ratio THS 2.2:CC|"The hypothesis to be tested is that the geometric mean level on Day 5 of the biomarker of exposure for THS 2.2 is lower relative to CC.~Analysis of the BoExp was conducted on the natural log scale in order to test the following hypothesis (one sided test with 2.5% type I error probability):~* Null hypothesis (H0): m1≥m2~* Alternative hypothesis (H1): m1\<m2 Where m1 and m2 are the geometric means of the BoExp levels on Day 5 for THS 2.2 and CC respectively."||6.87|5.21|<0.001
72626821|NCT01959932|144782676|SUPERIORITY_OR_OTHER_LEGACY||Geometric LS Mean Ratio|23.45|||<|0.001|TWO_SIDED|95.0|22.0|24.99||The primary endpoints were tested using a multiple testing procedure to preserve the overall alpha level by simultaneously testing the endpoints using a closed procedure with each test performed at an alpha level of 2.5% one sided.|ANCOVA|ANCOVA model on COHb levels with product, sex, cigarette consumption, and baseline value as covariates.|LS mean ratio THS 2.2:CC|"The hypothesis to be tested is that the geometric mean level on Day 5 of the biomarker of exposure for THS 2.2 is lower relative to CC.~Analysis of the BoExp was conducted on the natural log scale in order to test the following hypothesis (one sided test with 2.5% type I error probability):~* Null hypothesis (H0): m1≥m2~* Alternative hypothesis (H1): m1\<m2 Where m1 and m2 are the geometric means of the BoExp levels on Day 5 for THS 2.2 and CC respectively."||24.99|22.00|<0.001
72626822|NCT00758563|144782677|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANOVA|||||||0.05
72626823|NCT00060944|144782678|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.734||||0.0302|TWO_SIDED|95.0|0.554|0.974|||Log Rank|||||0.974|0.554|0.0302
72626824|NCT00060944|144782681|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.755||||0.0418|TWO_SIDED|95.0|0.574|0.992|||Log Rank|||||0.992|0.574|0.0418
72626825|NCT00060944|144782682|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.843||||0.192|TWO_SIDED|95.0|0.653|1.09|||Log Rank|||||1.090|0.653|0.1920
72626826|NCT01138514|144782683|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|provides 85% power of success|equivalence ratio|98.77||||0.05|TWO_SIDED|90.0|95.2|102.5|||Fieller's method|||||102.5|95.2|0.05
72626827|NCT01138514|144782684|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|provides 85% power of success|equivalence ratio|100.27||||0.05|TWO_SIDED|90.0|95.6|105.2|||Fieller's method|||||105.2|95.6|0.05
72409081|NCT00727857|144326684|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.2||||0.0435||95.0|0.06|4.33|||ANCOVA||Mean Difference = Pioglitazone - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||4.33|0.06|0.0435
72409082|NCT00727857|144326685|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.629||||0.3158||95.0|-0.602|1.861|||ANCOVA||Mean Difference = Pioglitazone \& metformin - pioglitazone|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||1.861|-0.602|0.3158
72409083|NCT00727857|144326685|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.619||||0.0067||95.0|0.452|2.785|||ANCOVA||Mean Difference = Pioglitazone \& metformin - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||2.785|0.452|0.0067
72409084|NCT00727857|144326685|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.989||||0.1094||95.0|-0.223|2.201|||ANCOVA||Mean Difference = Pioglitazone - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||2.201|-0.223|0.1094
72409085|NCT00727857|144326686|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|4.88||||0.5963||95.0|-4.71|13.97|||ANCOVA||The estimate of the median percent change from baseline and 95% confidence intervals were based on the Hodges-Lehmann method and the distribution-free confidence interval.|Nonparametric ANCOVA based on Tukey's normal rank transformation with a term for treatment and the baseline value as a covariate.||13.97|-4.71|0.5963
72409086|NCT00727857|144326686|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|12.81||||0.0265||95.0|2.88|22.24|||ANCOVA||The estimate of the median percent change from baseline and 95% confidence intervals were based on the Hodges-Lehmann method and the distribution-free confidence interval.|Nonparametric ANCOVA based on Tukey's normal rank transformation with a term for treatment and the baseline value as a covariate.||22.24|2.88|0.0265
72537126|NCT02050373|144605029|OTHER|For the comparison between the LLLT and control groups the Pearson chi-square (χ2) or Fisher's Exact tests were used.|||||<|0.05|||||||Fisher Exact|||The Pearson chi-square (χ2) or Fisher's Exact tests were used, at three different times (AD, D7, HD), to analyze the oral mucositis severity in the comparison between the LLLT and control groups. Statistical analysis was not performed for each grade of oral mucositis separately.||||<0.05
72537127|NCT02050373|144605030|OTHER|Student's t test was used to numerical variables with normal distribution. The Mann-Whitney test was used to compare the cytokine values of the two groups (control and laser). The Friedman test was used to indicate differences by comparing cytokine levels at different times of assessment within each group. The Friedman and Wilcoxon tests were used for paired analyzes of the saliva collection times in the groups. All tests were used to compare the groups at the three different times (AD, D7, HD).|||||<|0.05||||||p\<0,05|Wilcoxon (Mann-Whitney)|||||||<0.05
72537128|NCT03901339|144605031|OTHER||Hazard Ratio (HR)|0.653||||0.0001|TWO_SIDED|95.0|0.526|0.812||Stratified log-rank test and stratified Cox regression adjusted for stratification factors: prior chemotherapy regimens for metastatic disease, presence of visceral metastasis and endocrine therapy in the metastatic setting for at least 6 months.|Log Rank|||||0.812|0.526|0.0001
72409087|NCT00727857|144326686|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|8.33||||0.1053||95.0|-1.77|18.07|||ANCOVA||The estimate of the median percent change from baseline and 95% confidence intervals were based on the Hodges-Lehmann method and the distribution-free confidence interval.|Nonparametric ANCOVA based on Tukey's normal rank transformation with a term for treatment and the baseline value as a covariate.||18.07|-1.77|0.1053
72409088|NCT00727857|144326687|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.4||||0.0806||95.0|-0.2|3.1|||ANCOVA||Mean Difference = Pioglitazone \& metformin - pioglitazone|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||3.1|-0.2|0.0806
72409089|NCT00727857|144326687|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.1|||<|0.0001||95.0|-9.6|-6.5|||ANCOVA||Mean Difference = Pioglitazone \& metformin - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||-6.5|-9.6|<0.0001
72409090|NCT00727857|144326687|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.5|||<|0.0001||95.0|-11.1|-7.9|||ANCOVA||Mean Difference = Pioglitazone - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||-7.9|-11.1|<0.0001
72409091|NCT00727857|144326688|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.73||||0.0324||95.0|0.31|7.14|||ANCOVA||Mean Difference = Pioglitazone \& metformin - pioglitazone|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||7.14|0.31|0.0324
72409092|NCT00727857|144326688|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.78||||0.0233||95.0|-7.05|-0.52|||ANCOVA||Mean Difference = Pioglitazone \& metformin - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||-0.52|-7.05|0.0233
72409093|NCT00727857|144326688|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.51|||<|0.0001||95.0|-10.9|-4.12|||ANCOVA||Mean Difference = Pioglitazone - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||-4.12|-10.90|<0.0001
72409094|NCT00727857|144326689|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.9||||0.0993||95.0|-0.93|10.72|||ANCOVA||Mean Difference = Pioglitazone \& metformin - pioglitazone|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||10.72|-0.93|0.0993
72409095|NCT00727857|144326689|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.56||||0.367||95.0|-8.14|3.01|||ANCOVA||Mean Difference = Pioglitazone \& metformin - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||3.01|-8.14|0.3670
72409096|NCT00727857|144326689|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.46||||0.0119||95.0|-13.26|-1.66|||ANCOVA||Mean Difference = Pioglitazone - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||-1.66|-13.26|0.0119
72537129|NCT03901339|144605032|OTHER||Hazard Ratio (HR)|0.788||||0.0133|TWO_SIDED|95.0|0.652|0.952||Stratified log-rank test and stratified Cox regression adjusted for stratification factors: prior chemotherapy regimens for metastatic disease, presence of visceral metastasis, and endocrine therapy in the metastatic setting for at least 6 months.|Log Rank|||||0.952|0.652|0.0133
72537130|NCT03901339|144605033|OTHER||Odds Ratio (OR)|1.662||||0.0268|TWO_SIDED|95.0|1.058|2.609|||Cochran-Mantel-Haenszel|||ORR by BICR Assessment||2.609|1.058|0.0268
72537131|NCT03901339|144605033|OTHER||Odds Ratio (OR)|1.989||||0.0098|TWO_SIDED|95.0|1.174|3.369|||Cochran-Mantel-Haenszel|||ORR by LIR Assessment||3.369|1.174|0.0098
72537132|NCT03901339|144605035|OTHER||Odds Ratio (OR)|1.796||||0.0025|TWO_SIDED|95.0|1.227|2.628|||Cochran-Mantel-Haenszel|||CBR by BICR Assessment||2.628|1.227|0.0025
72537133|NCT03901339|144605035|OTHER||Odds Ratio (OR)|1.834||||0.0024|TWO_SIDED|95.0|1.237|2.717|||Cochran-Mantel-Haenszel|||CBR by LIR Assessment||2.717|1.237|0.0024
72537134|NCT03901339|144605036|OTHER||Hazard Ratio (HR)|0.728||||0.001|TWO_SIDED|95.0|0.602|0.881||Stratified log-rank test and stratified Cox regression adjusted for stratification factors: prior chemotherapy regimens for metastatic disease, presence of visceral metastasis, and endocrine therapy in the metastatic setting for at least 6 months.|Log Rank|||||0.881|0.602|0.0010
72537135|NCT03901339|144605037|OTHER||Hazard Ratio (HR)|0.751||||0.0059|TWO_SIDED|95.0|0.612|0.922||Stratified log-rank test and stratified Cox regression adjusted for stratification factors: prior chemotherapy regimens for metastatic disease, presence of visceral metastasis, and endocrine therapy in the metastatic setting for at least 6 months.|Log Rank|||||0.922|0.612|0.0059
72537136|NCT03901339|144605038|OTHER||Hazard Ratio (HR)|0.918||||0.4151|TWO_SIDED|95.0|0.748|1.126||Stratified log-rank test and stratified Cox regression adjusted for stratification factors: prior chemotherapy regimens for metastatic disease, presence of visceral metastasis, and endocrine therapy in the metastatic setting for at least 6 months.|Log Rank|||||1.126|0.748|0.4151
72537137|NCT03901339|144605039|OTHER||Hazard Ratio (HR)|0.732||||0.0021|TWO_SIDED|95.0|0.598|0.894||Stratified log-rank test and stratified Cox regression adjusted for stratification factors: prior chemotherapy regimens for metastatic disease, presence of visceral metastasis, and endocrine therapy in the metastatic setting for at least 6 months.|Log Rank|||||0.894|0.598|0.0021
72537138|NCT01569074|144605083|SUPERIORITY_OR_OTHER||Weighted difference in proportions|0.23||||0.059|TWO_SIDED|80.0|0.07|0.39||Week 12|Mantel Haenszel|Treatment difference in proportion of responders, with a Mantel-Haenszel approach stratified by pooled country.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or following receipt of any parenteral steroids, or for patients with no post baseline data. Subjects who prematurely withdrew due to project closure have no imputation applied.||0.39|0.07|0.059
72537139|NCT01569074|144605083|SUPERIORITY_OR_OTHER||Weighted difference in proportions|0.24||||0.054|TWO_SIDED|80.0|0.08|0.39||Week 12|Mantel Haenszel|Treatment difference in proportion of responders, with a Mantel-Haenszel approach stratified by pooled country.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or following receipt of any parenteral steroids, or for patients with no post baseline data. Subjects who prematurely withdrew due to project closure have no imputation applied||0.39|0.08|0.054
72537140|NCT01569074|144605083|SUPERIORITY_OR_OTHER||Weighted difference in proportions|-0.06||||0.57|TWO_SIDED|80.0|-0.2|0.08||Week 12|Mantel Haenszel|Treatment difference in proportion of responders, with a Mantel-Haenszel approach stratified by pooled country.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or following receipt of any parenteral steroids, or for patients with no post baseline data. Subjects who prematurely withdrew due to project closure have no imputation applied||0.08|-0.20|0.570
72369226|NCT00611026|144248557|SUPERIORITY_OR_OTHER|||||||0.0217|TWO_SIDED|||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with country and treatment as factors, and ranked baseline value as a covariate.||Treatment difference fesoterodine vs Tolterodine ER at Week 4.||||0.0217
72537141|NCT01569074|144605083|SUPERIORITY_OR_OTHER||Weighted difference in proportions|0.14||||0.262|TWO_SIDED|80.0|-0.02|0.29||Week 12|Mantel Haenszel|Treatment difference in proportion of responders, with a Mantel-Haenszel approach stratified by pooled country.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or following receipt of any parenteral steroids, or for patients with no post baseline data. Subjects who prematurely withdrew due to project closure have no imputation applied||0.29|-0.02|0.262
72369227|NCT00611026|144248557|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with country and treatment as factors, and ranked baseline value as a covariate.||Treatment difference fesoterodine vs placebo at Week 12.||||<0.0001
72369228|NCT00611026|144248557|SUPERIORITY_OR_OTHER|||||||0.0421|TWO_SIDED|||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with country and treatment as factors, and ranked baseline value as a covariate.||Treatment difference Tolterodine ER vs placebo at Week 12.||||0.0421
72369229|NCT00611026|144248557|SUPERIORITY_OR_OTHER|||||||0.0023|TWO_SIDED|||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with country and treatment as factors, and ranked baseline value as a covariate.||Treatment difference fesoterodine vs Tolterodine ER at Week 12.||||0.0023
72369230|NCT00611026|144248558|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.1||0.3823|TWO_SIDED|95.0|-0.1|0.1|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.|"Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type:~standard error of the mean."|Treatment difference fesoterodine vs placebo at Week 1.||0.1|-0.1|0.3823
72537142|NCT01569074|144605084|SUPERIORITY_OR_OTHER||Weighted difference in proportions|0.11||||0.172|TWO_SIDED|80.0|0.01|0.21||Week 1|Mantel Haenszel|Treatment difference in proportion of responders, with a Mantel-Haenszel approach stratified by pooled country.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or following receipt of any parenteral steroids, or for patients with no post baseline data. Subjects who prematurely withdrew due to project closure have no imputation applied||0.21|0.01|0.172
72537143|NCT01569074|144605084|SUPERIORITY_OR_OTHER||Weighted difference in proportions|0.06||||0.489|TWO_SIDED|80.0|-0.05|0.18||Week 1|Mantel Haenszel|Treatment difference in proportion of responders, with a Mantel-Haenszel approach stratified by pooled country.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or following receipt of any parenteral steroids, or for patients with no post baseline data. Subjects who prematurely withdrew due to project closure have no imputation applied||0.18|-0.05|0.489
72573444|NCT03469336|144673388|OTHER|Ratio|Mean Ratio (Test/Reference)|0.7946|STANDARD_ERROR_OF_MEAN|0.732||0.754|TWO_SIDED|95.0|0.1858|3.3977|||Mixed Models Analysis|||The effect of PF-06763809 compared to calcipotriene/calcipotriol solution in the change of psoriatic skin infiltrate thickness/EPB on Day 19.||3.3977|0.1858|0.7540
72573445|NCT03469336|144673388|OTHER|Ratio|Mean Ratio (Test/Reference)|0.7844|STANDARD_ERROR_OF_MEAN|0.732||0.7407|TWO_SIDED|95.0|0.1834|3.354|||Mixed Models Analysis|||The effect of PF-06763809 compared to calcipotriene/calcipotriol solution in the change of psoriatic skin infiltrate thickness/EPB on Day 19.||3.3540|0.1834|0.7407
72573446|NCT03469336|144673388|OTHER|Ratio|Mean Ratio (Test/Reference)|0.8946|STANDARD_ERROR_OF_MEAN|0.732||0.8793|TWO_SIDED|95.0|0.2092|3.8256|||Mixed Models Analysis|||The effect of PF-06763809 compared to calcipotriene/calcipotriol solution in the change of psoriatic skin infiltrate thickness/EPB on Day 19.||3.8256|0.2092|0.8793
72573447|NCT03469336|144673389|OTHER|Ratio|Mean Ratio (Test/Reference)|1.081321|STANDARD_ERROR_OF_MEAN|0.732|<|0.0001|TWO_SIDED|95.0|0.25287|4.623941|||Mixed Models Analysis|||The effect of PF-06763809 compared to betamethasone solution in the change of psoriatic skin infiltrate thickness/EPB on Day 19.||4.623941|0.25287|<0.0001
72573448|NCT03469336|144673389|OTHER|Ratio|Mean Ratio (Test/Reference)|1.067453|STANDARD_ERROR_OF_MEAN|0.732|<|0.0001|TWO_SIDED|95.0|0.249631|4.564555|||Mixed Models Analysis|||The effect of PF-06763809 compared to betamethasone solution in the change of psoriatic skin infiltrate thickness/EPB on Day 19.||4.564555|0.249631|<0.0001
72573449|NCT03469336|144673389|OTHER|Ratio|Mean Ratio (Test/Reference)|1.217483|STANDARD_ERROR_OF_MEAN|0.732|<|0.0001|TWO_SIDED|95.0|0.284708|5.206258|||Mixed Models Analysis|||The effect of PF-06763809 compared to betamethasone solution in the change of psoriatic skin infiltrate thickness/EPB on Day 19.||5.206258|0.284708|<0.0001
72573450|NCT02109419|144673390|OTHER||Pearson Test-retest reliability coeff.|0.8|||<|0.0001|TWO_SIDED||||||Pearson Test-retest reliability coeff.|||HHT-D reliability was evaluated via test-retest reliability coefficients. The dataset included participants from all groups.||||<0.0001
72573451|NCT02109419|144673390|OTHER||Pearson test-retest reliability coeff|0.87|||<|0.0001|TWO_SIDED||||||Pearson test-retest reliability coeff|||HHT-G reliability was evaluated via test-retest reliability coefficients. The dataset included participants from all groups.||||<0.0001
72573452|NCT02109419|144673390|OTHER||Pearson correlation coefficient|0.6|||<|0.0001|TWO_SIDED||||||Pearson correlation coefficient|||Validity of the HHT-D was tested by Pearson correlation coefficients between HHT-D and Geriatric Depression Scale (GDS) scores. The dataset included participants from all groups.||||<.0001
72573453|NCT02109419|144673390|OTHER||Pearson correlation coefficient|0.71||||0.0001|TWO_SIDED||||||Pearson correlation coefficient|||Validity of the HHT-G was tested by Pearson correlation coefficients between HHT-G and Mini-Mental State Examination (MMSE) scores. The dataset included participants from all groups.||||0.0001
72573454|NCT02109419|144673390|OTHER||Chronbach's alpha|0.73|||||TWO_SIDED|||||||||Internal consistency reliability of the HHT-D was assessed with Chronbach's alpha. The dataset included participants from all groups.||||
72573455|NCT02109419|144673390|OTHER||Chronbach's alpha|0.7|||||TWO_SIDED|||||||||Internal consistency reliability of the HHT-G was assessed with Chronbach's alpha. The dataset included participants from all groups.||||
72573456|NCT00289536|144673485|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1662|||||||ANOVA|Repeated measures ANOVA with dose as fixed effect||Null Hypothesis: The mean log initial recovery will be the same in each dose group.||||0.1662
72573457|NCT00289536|144673486|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0965||||||No adjustments were made for multiple comparisons.|ANOVA|Repeated measures ANOVA with dose as fixed effect||Null Hypothesis: The mean log AUC/dose will be the same in each dose group.||||0.0965
72573458|NCT00289536|144673487|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5057|||||||ANOVA|Repeated measures ANOVA with dose as fixed effect||Null Hypothesis: The mean terminal half-life will be the same in each dose group.||||0.5057
72573459|NCT00289536|144673495|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7048||||||No adjustments were made for multiple comparisons.|Regression, Linear|||Regression analysis: Relationship of initial recovery to pre-infusion level of VWF:Rco with dose groups combined.||||0.7048
72573460|NCT00289536|144673495|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0322||||||No adjustments were made for multiple comparisons.|Regression, Linear|||Regression analysis: relationship of AUC/Dose to pre-infusion level of VWF:Rco with dose groups combined.||||.0322
72573461|NCT00289536|144673495|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0056||||||No adjustments were made for multiple comparisons.|Regression, Linear|||Regression analysis: relationship of terminal half-life to pre-infusion level of VWF:Rco with dose groups combined.||||0.0056
72573462|NCT00289536|144673496|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3696||||||No adjustments were made for multiple comparisons.|Regression, Linear|||Regression analysis: relationship of initial recovery to pre-infusion level of VWF:Ag with dose groups combined.||||0.3696
72409097|NCT00727857|144326690|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.31||||0.0423||95.0|-8.48|-0.15|||ANCOVA||Mean Difference = Pioglitazone \& metformin - pioglitazone|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||-0.15|-8.48|0.0423
72409098|NCT00727857|144326690|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.1|||<|0.0001||95.0|-12.08|-4.12|||ANCOVA||Mean Difference = Pioglitazone \& metformin - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||-4.12|-12.08|<0.0001
72409099|NCT00727857|144326690|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.79||||0.728||95.0|-7.93|0.35|||ANCOVA||Mean Difference = Pioglitazone - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||0.35|-7.93|0.728
72626828|NCT01138514|144782685|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|"Clinical success was defined as a score of clear (0) or almost clear (1) on Investigators Global Assessment (IGA) at Visit 4/Week 10"|equivalence difference|1.6||||0.05|TWO_SIDED|90.0|-4.2|7.4|||Wald's method Yates' continuity correct|||||7.4|-4.2|0.05
72626829|NCT04549454|144782734|SUPERIORITY||Mean Difference (Final Values)|-0.011|STANDARD_ERROR_OF_MEAN|0.598||0.985|TWO_SIDED||||||Tukey-Kramer|||As detailed in the statistical analysis plan, a multi-level model which held constant participant age, race, ethnicity, in examining Time\*Arm interactions on weekly drinks. To probe the significant Time\*Arm interaction, a Tukey post-hoc test examined the change in weekly drinks from baseline to the 1-month follow-up in the Intervention Arm versus the Control Arm.||||.985
72626830|NCT04549454|144782735|SUPERIORITY||Mean Difference (Final Values)|0.244|STANDARD_ERROR_OF_MEAN|0.618||0.694|TWO_SIDED||||||Tukey-Kramer|||As detailed in the statistical analysis plan, a multi-level model which held constant participant age, race, ethnicity, in examining Time\*Arm interactions on weekly drinks. To probe the significant Time\*Arm interaction, a Tukey post-hoc test examined the change in weekly drinks from baseline to the 6-month follow-up in the Intervention Arm versus the Control Arm.||||.694
72409100|NCT00727857|144326691|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.41||||0.9231||95.0|-7.94|8.76|||ANCOVA||Mean Difference = Pioglitazone \& metformin - pioglitazone|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||8.76|-7.94|0.9231
72409101|NCT00727857|144326691|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.16||||0.3082||95.0|-3.86|12.19|||ANCOVA||Mean Difference = Pioglitazone \& metformin - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||12.19|-3.86|0.3082
72409102|NCT00727857|144326691|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.75||||0.3753||95.0|-4.56|12.07|||ANCOVA||Mean Difference = Pioglitazone - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||12.07|-4.56|0.3753
72409103|NCT00727857|144326692|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|23.4||||0.4999||95.0|-44.6|91.4|||ANCOVA||Mean Difference = Pioglitazone \& metformin - pioglitazone|One-way ANCOVA with a term for treatment and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||91.4|-44.6|0.4999
72409104|NCT00727857|144326692|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|64.2||||0.0531||95.0|-0.9|129.3|||ANCOVA||Mean Difference = Pioglitazone \& metformin - metformin|One-way ANCOVA with a term for treatment and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||129.3|-0.9|0.0531
72409105|NCT00727857|144326692|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|40.9||||0.2369||95.0|-26.9|108.7|||ANCOVA||Mean Difference = Pioglitazone - metformin|One-way ANCOVA with a term for treatment and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||108.7|-26.9|0.2369
72626831|NCT04549454|144782736|SUPERIORITY||Mean Difference (Final Values)|-0.045|STANDARD_ERROR_OF_MEAN|0.327||0.889|TWO_SIDED||||||Tukey-Kramer|||As detailed in the statistical analysis plan, a multi-level model which held constant participant age, race, ethnicity, in examining Time\*Arm interactions on consequences. To probe the significant Time\*Arm interaction, a Tukey post-hoc test examined the change in consequences from baseline to the 1-month follow-up in the Intervention Arm versus the Control Arm.||||.889
72409106|NCT00727857|144326693|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.05||||0.5023||95.0|-0.09|0.19|||ANCOVA||Mean Difference = Pioglitazone \& metformin - pioglitazone|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||0.19|-0.09|0.5023
72537144|NCT01569074|144605084|SUPERIORITY_OR_OTHER||Weighted difference in proportions|0.03||||0.704|TWO_SIDED|80.0|-0.08|0.15||Week 1|Mantel Haenszel|Treatment difference in proportion of responders, with a Mantel-Haenszel approach stratified by pooled country.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or following receipt of any parenteral steroids, or for patients with no post baseline data. Subjects who prematurely withdrew due to project closure have no imputation applied||0.15|-0.08|0.704
72537145|NCT01569074|144605085|SUPERIORITY_OR_OTHER||Weighted difference in proportions|0.17||||0.114|TWO_SIDED|80.0|0.03|0.31||Week 12|Mantel Haenszel|Treatment difference in proportion of responders, with a Mantel-Haenszel approach stratified by pooled country.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or following receipt of any parenteral steroids, or for patients with no post baseline data. Subjects who prematurely withdrew due to project closure have no imputation applied||0.31|0.03|0.114
72537146|NCT01569074|144605085|SUPERIORITY_OR_OTHER||Weighted difference in proportions|0.21||||0.035|TWO_SIDED|80.0|0.08|0.34||Week 12|Mantel Haenszel|Treatment difference in proportion of responders, with a Mantel-Haenszel approach stratified by pooled country.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or following receipt of any parenteral steroids, or for patients with no post baseline data. Subjects who prematurely withdrew due to project closure have no imputation applied||0.34|0.08|0.035
72537147|NCT01569074|144605085|SUPERIORITY_OR_OTHER||Weighted difference in proportions|-0.07||||0.334|TWO_SIDED|80.0|-0.17|0.02||Week 12|Mantel Haenszel|Treatment difference in proportion of responders, with a Mantel-Haenszel approach stratified by pooled country.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or following receipt of any parenteral steroids, or for patients with no post baseline data. Subjects who prematurely withdrew due to project closure have no imputation applied||0.02|-0.17|0.334
72537148|NCT01569074|144605085|SUPERIORITY_OR_OTHER||Weighted difference in proportions|-0.04||||0.645|TWO_SIDED|80.0|-0.13|0.06||Week 12|Mantel Haenszel|Treatment difference in proportion of responders, with a Mantel-Haenszel approach stratified by pooled country.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or following receipt of any parenteral steroids, or for patients with no post baseline data. Subjects who prematurely withdrew due to project closure have no imputation applied||0.06|-0.13|0.645
72537149|NCT01569074|144605086|SUPERIORITY_OR_OTHER||Weighted difference in proportions|0.12||||0.028|TWO_SIDED|80.0|0.05|0.19||Week 12|Mantel Haenszel|Treatment difference in proportion of responders, with a Mantel-Haenszel approach stratified by pooled country.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or following receipt of any parenteral steroids, or for patients with no post baseline data. Subjects who prematurely withdrew due to project closure have no imputation applied||0.19|0.05|0.028
72537150|NCT01569074|144605086|SUPERIORITY_OR_OTHER||Weighted difference in proportions|0.14||||0.021|TWO_SIDED|80.0|0.06|0.22||Week 12|Mantel Haenszel|Treatment difference in proportion of responders, with a Mantel-Haenszel approach stratified by pooled country.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or following receipt of any parenteral steroids, or for patients with no post baseline data. Subjects who prematurely withdrew due to project closure have no imputation applied||0.22|0.06|0.021
72537151|NCT01569074|144605087|SUPERIORITY_OR_OTHER|||||||0.073||||||As this is a non-parametric test, p-values alone are presented rather than an estimated treatment difference.|Van Elteren|P-value estimated using the Van Elteren method stratified by pooled country.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or following receipt of any parenteral steroids, or for patients with no post baseline data. Subjects who prematurely withdrew due to project closure have no imputation applied||||0.073
72537152|NCT01569074|144605087|SUPERIORITY_OR_OTHER|||||||0.065||||||As this is a non-parametric test, p-values alone are presented rather than an estimated treatment difference.|Van Elteren|P-value estimated using the Van Elteren test stratified by pooled country.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or following receipt of any parenteral steroids, or for patients with no post baseline data. Subjects who prematurely withdrew due to project closure have no imputation applied||||0.065
72537153|NCT01569074|144605087|SUPERIORITY_OR_OTHER|||||||0.317||||||As this is a non-parametric test, p-values alone are presented rather than an estimated treatment difference.|Van Elteren|P-value estimated using the Van Elteren method stratified by pooled country.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or following receipt of any parenteral steroids, or for patients with no post baseline data. Subjects who prematurely withdrew due to project closure have no imputation applied||||0.317
72573463|NCT00289536|144673496|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0001||||||No adjustments were made for multiple comparisons.|Regression, Linear|||Regression analysis: relationship of AUC/Dose to pre-infusion level of VWF:Ag with dose groups combined.||||0.0001
72409107|NCT00727857|144326693|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.34|||<|0.0001||95.0|-0.48|-0.21|||ANCOVA||Mean Difference = Pioglitazone \& metformin - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||-0.21|-0.48|<0.0001
72409108|NCT00727857|144326693|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.39|||<|0.0001||95.0|-0.53|-0.25|||ANCOVA||Mean Difference = Pioglitazone - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||-0.25|-0.53|<0.0001
72409109|NCT00727857|144326694|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|19.7||||0.2849||95.0|-16.5|55.9|||ANCOVA||Mean Difference = Pioglitazone \& metformin - pioglitazone|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||55.9|-16.5|0.2849
72537154|NCT01569074|144605087|SUPERIORITY_OR_OTHER|||||||0.263||||||As this is a non-parametric test, p-values alone are presented rather than an estimated treatment difference.|Van Elteren|P-value estimated using the Van Elteren method stratified by pooled country.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or following receipt of any parenteral steroids, or for patients with no post baseline data. Subjects who prematurely withdrew due to project closure have no imputation applied||||0.263
72537155|NCT01569074|144605088|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.3||||0.033|TWO_SIDED|80.0|1.94|14.31|||Regression, Logistic|Odds ratio and 80% confidence intervals are calculated using Logistic Regression with treatment and pooled country as factors.|An odds ratio of \>1 indicates a benefit towards fostamatinib.|Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or following receipt of any parenteral steroids, or for patients with no post baseline data. Subjects who prematurely withdrew due to project closure have no imputation applied||14.31|1.94|0.033
72537156|NCT01569074|144605088|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.1||||0.033|TWO_SIDED|80.0|1.92|13.61|||Regression, Logistic|Odds ratio and 80% confidence intervals are calculated using Logistic Regression with treatment and pooled country as factors.|An odds ratio of \>1 indicates a benefit towards fostamatinib.|Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or following receipt of any parenteral steroids, or for patients with no post baseline data. Subjects who prematurely withdrew due to project closure have no imputation applied.||13.61|1.92|0.033
72537157|NCT01569074|144605088|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.5||||0.257|TWO_SIDED|80.0|0.89|6.89|||Regression, Logistic|Odds ratio and 80% confidence intervals are calculated using Logistic Regression with treatment and pooled country as factors.|An odds ratio of \>1 indicates a benefit towards fostamatinib.|Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or following receipt of any parenteral steroids, or for patients with no post baseline data. Subjects who prematurely withdrew due to project closure have no imputation applied.||6.89|0.89|0.257
72537158|NCT01569074|144605088|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.8||||0.481|TWO_SIDED|80.0|0.63|5.04|||Regression, Logistic|Odds ratio and 80% confidence intervals are calculated using Logistic Regression with treatment and pooled country as factors.|An odds ratio of \>1 indicates a benefit towards fostamatinib.|Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or following receipt of any parenteral steroids, or for patients with no post baseline data. Subjects who prematurely withdrew due to project closure have no imputation applied.||5.04|0.63|0.481
72537159|NCT01569074|144605089|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.17||||0.131|TWO_SIDED|80.0|1.12|4.2|||Proportional odds model|No response, moderate response and good response are included in the proportional odds model with treatment and pooled country as factors.|An odds ratio \>1 indicates a benefit towards fostamatinib.|Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or following receipt of any parenteral steroids, or for patients with no post baseline data. Subjects who prematurely withdrew due to project closure have no imputation applied.||4.20|1.12|0.131
72537160|NCT01569074|144605089|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.49||||0.423|TWO_SIDED|80.0|0.79|2.82|||Proportional odds model|No response, moderate response and good response are included in the proportional odds model with treatment and pooled country as factors.|An odds ratio \>1 indicates a benefit towards fostamatinib.|Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or following receipt of any parenteral steroids, or for patients with no post baseline data. Subjects who prematurely withdrew due to project closure have no imputation applied.||2.82|0.79|0.423
72537161|NCT01569074|144605089|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.87||||0.781|TWO_SIDED|80.0|0.45|1.67|||Proportional odds model|No response, moderate response and good response are included in the proportional odds model with treatment and country as factors.|An odds ratio \>1 indicates a benefit towards fostamatinib.|Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or following receipt of any parenteral steroids, or for patients with no post baseline data. Subjects who prematurely withdrew due to project closure have no imputation applied.||1.67|0.45|0.781
72537162|NCT01569074|144605089|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.81||||0.239|TWO_SIDED|80.0|0.95|3.44|||Proportional odds model|No response, moderate response and good response are included in the proportional odds model with treatment and country as factors.|An odds ratio \>1 indicates a benefit towards fostamatinib|Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or following receipt of any parenteral steroids, or for patients with no post baseline data. Subjects who prematurely withdrew due to project closure have no imputation applied.||3.44|0.95|0.239
72537163|NCT01569074|144605090|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.2||||0.169|TWO_SIDED|80.0|1.06|4.67||Week 12|Regression, Logistic|Odds ratio and 80% confidence intervals are calculated using Logistic Regression with treatment and pooled country as factors.|An odds ration \>1 indicates a benefit towards fostamatinib|Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or following receipt of any parenteral steroids, or for patients with no post baseline data. Subjects who prematurely withdrew due to project closure have no imputation applied.||4.67|1.06|0.169
72573464|NCT00289536|144673496|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||No adjustments were made for multiple comparisons.|Regression, Linear|||Regression analysis: relationship of terminal half-life to pre-infusion level of VWF:Ag with dose groups combined.||||<0.0001
72573465|NCT00265395|144673533|SUPERIORITY_OR_OTHER||SVR Rate Difference|-4.9||||0.6445||95.0|-20.4|10.6|||Asymptotic Z-test|||||10.6|-20.4|0.6445
72626832|NCT04549454|144782737|SUPERIORITY||Mean Difference (Final Values)|-0.186|STANDARD_ERROR_OF_MEAN|0.338||0.582|TWO_SIDED||||||Tukey-Kramer|||As detailed in the statistical analysis plan, a multi-level model which held constant participant age, race, ethnicity, in examining Time\*Arm interactions on consequences. To probe the significant Time\*Arm interaction, a Tukey post-hoc test examined the change in consequences from baseline to the 6-month follow-up in the Intervention Arm versus the Control Arm.||||.582
72409110|NCT00727857|144326694|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-77.6|||<|0.0001||95.0|-112.4|-42.8|||ANCOVA||Mean Difference = Pioglitazone \& metformin - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||-42.8|-112.4|<0.0001
72409111|NCT00727857|144326694|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-97.3|||<|0.0001||95.0|-133.4|-61.2|||ANCOVA||Mean Difference = Pioglitazone - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||-61.2|-133.4|<0.0001
72409112|NCT00727857|144326695|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.3||||0.2894||95.0|-4.5|15.1|||ANCOVA||Mean Difference = Pioglitazone \& metformin - pioglitazone|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||15.1|-4.5|0.2894
72537164|NCT01569074|144605090|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.9||||0.833|TWO_SIDED|80.0|0.45|1.78||Week 12|Regression, Logistic|Odds ratio and 80% confidence intervals are calculated using Logistic Regression with treatment and pooled country as factors.|An odds ratio \>1 indicates a benefit towards fostamatinib.|Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or following receipt of any parenteral steroids, or for patients with no post baseline data. Subjects who prematurely withdrew due to project closure have no imputation applied.||1.78|0.45|0.833
72537165|NCT01569074|144605090|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.8||||0.614|TWO_SIDED|80.0|0.37|1.54||Week 12|Regression, Logistic|Odds ratio and 80% confidence intervals are calculated using Logistic Regression with treatment and pooled country as factors.|An odds ratio of \>1 indicates a benefit towards fostamatinib.|Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or following receipt of any parenteral steroids, or for patients with no post baseline data. Subjects who prematurely withdrew due to project closure have no imputation applied.||1.54|0.37|0.614
72537166|NCT01569074|144605090|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.8||||0.748|TWO_SIDED|80.0|0.42|1.69||Week 12|Regression, Logistic|Odds ratio and 80% confidence intervals are calculated using Logistic Regression with treatment and pooled country as factors.|An odds ratio of \>1 indicates a benefit towards fostamatinib.|Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or following receipt of any parenteral steroids, or for patients with no post baseline data. Subjects who prematurely withdrew due to project closure have no imputation applied.||1.69|0.42|0.748
72537167|NCT01569074|144605091|SUPERIORITY_OR_OTHER||Treatment difference|3.01||||0.087|TWO_SIDED|80.0|0.76|5.26|||ANCOVA|Including terms for baseline as a continuous covariate and treatment and pooled country as factors.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or following receipt of any parenteral steroids, or for patients with no post baseline data. Subjects who prematurely withdrew due to project closure have no imputation applied.||5.26|0.76|0.087
72573466|NCT00271154|144673534|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||Null hypothesis: mean 12-month change in LVESVi in group 1 = mean 12-month change in LVESVi in group 2.||||<0.0001
72573467|NCT00271154|144673535|SUPERIORITY_OR_OTHER|||||||0.1||95.0|||||Chi-squared|||Null hypothesis: Percentage worsened in CRT OFF group = Percentage worsened in CRT ON group||||0.10
72626833|NCT04549454|144782738|SUPERIORITY||Mean Difference (Final Values)|-0.265|STANDARD_ERROR_OF_MEAN|0.414||0.523|TWO_SIDED||||||Tukey-Kramer|||As detailed in the statistical analysis plan, a multi-level model which held constant participant age, race, ethnicity, in examining Time\*Arm interactions on peak drinks. To probe the significant Time\*Arm interaction, a Tukey post-hoc test examined the change in peak drinks from baseline to the 1-month follow-up in the Intervention Arm versus the Control Arm.||||.523
72409113|NCT00727857|144326695|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9||||0.8463||95.0|-10.3|8.5|||ANCOVA||Mean Difference = Pioglitazone \& metformin - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||8.5|-10.3|0.8463
72409114|NCT00727857|144326695|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.2||||0.2124||95.0|-16.0|3.6|||ANCOVA||Mean Difference = Pioglitazone - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||3.6|-16.0|0.2124
72409115|NCT00727857|144326696|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.2||||0.804||95.0|-19.4|15.0|||ANCOVA||Mean Difference = Pioglitazone \& metformin - pioglitazone|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||15.0|-19.4|0.8040
72573468|NCT02338193|144673548|SUPERIORITY||||||<|0.032|||||||ANOVA|||One Way ANOVA with Bonferroni contrast if p\>0.05||||<0.032
72573469|NCT02338193|144673549|SUPERIORITY||||||<|0.05|||||||ANOVA|One Way ANOVA with Bonferoni contrast test||||||<0.05
72573470|NCT02338193|144673550|SUPERIORITY||||||<|0.01|||||||ANOVA|||Factorial repeated measures ANOVA with Bonferroni contrast test||||<0.01
72573471|NCT02338193|144673551|SUPERIORITY||||||<|0.012|||||||ANOVA|||Factorial repeated measures ANOVA with Bonferroni contrast test||||<0.012
72573472|NCT02338193|144673552|SUPERIORITY|||||||0.007|||||||ANOVA|||Factorial repeated measures ANOVA with Bonferroni contrast test||||0.007
72573473|NCT02338193|144673553|SUPERIORITY|||||||0.023|||||||ANOVA|||Factorial repeated measures ANOVA with Bonferroni contrast||||0.023
72573474|NCT02338193|144673554|SUPERIORITY||||||>|0.05|||||||ANOVA|||Factorial repeated measures ANOVA with Bonferroni contrast||||>0.05
72573475|NCT02338193|144673555|SUPERIORITY||||||>|0.05|||||||ANOVA|||Factorial repeated measures ANOVA with Bonferroni contrast||||>0.05
72573476|NCT02338193|144673556|SUPERIORITY||||||<|0.001|||||||ANOVA|||Factorial repeated measures ANOVA with Bonferroni contrast||||<0.001
72573477|NCT02338193|144673557|SUPERIORITY||||||<|0.001|||||||ANOVA|||Factorial repeated measures ANOVA with Bonferroni contrast test||||<0.001
72573478|NCT02338193|144673558|SUPERIORITY||||||<|0.004|||||||ANOVA|||Factorial repeated measures ANOVA with Bonferroni contrast test||||<0.004
72409116|NCT00727857|144326696|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|28.5||||0.0008||95.0|12.0|45.0|||ANCOVA||Mean Difference = Pioglitazone \& metformin - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||45.0|12.0|0.0008
72409117|NCT00727857|144326696|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|30.6||||0.0005||95.0|13.4|47.8|||ANCOVA||Mean Difference = Pioglitazone - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||47.8|13.4|0.0005
72573479|NCT02338193|144673559|SUPERIORITY||||||<|0.02|||||||ANOVA|||Factorial repeated measures ANOVA with Bonferroni contrast test||||<0.02
72573480|NCT02338193|144673560|SUPERIORITY||||||<|0.012|||||||ANOVA|||Factorial repeated measures ANOVA with Bonferroni contrast test||||<0.012
72409118|NCT00727857|144326697|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.1||||0.9604||95.0|-83.3|79.2|||ANCOVA||Mean Difference = Pioglitazone \& metformin - pioglitazone|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||79.2|-83.3|0.9604
72573481|NCT02338193|144673561|SUPERIORITY||||||>|0.05|||||||ANOVA|||Factorial repeated measures ANOVA with Bonferroni contrast test||||>0.05
72573482|NCT02338193|144673562|SUPERIORITY||||||<|0.028|||||||ANOVA|||Factorial repeated measures ANOVA with Bonferroni contrast test||||<0.028
72573483|NCT02338193|144673563|SUPERIORITY||||||<|0.03|||||||ANOVA|||Factorial repeated measures ANOVA with Bonferroni contrast test||||<.03
72573484|NCT00123474|144673564|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority of the QD schedule relative to the BID schedule was deduced if the lower bound of the 95% confidence interval (CI) for the MCyRRQD minus MCyRRBID difference was greater than or equal to -15%.|Risk Difference (RD)|2.8|||||TWO_SIDED|95.0|-6.0|11.6||||||6 Month Analysis||11.6|-6.0|
72573485|NCT00123474|144673565|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority of the QD schedule relative to the BID schedule was deduced if the lower bound of the 95% CI for the MCyRRQD minus MCyRRBID difference was greater than or equal to -15%.|Risk Difference (RD)|1.9|||||TWO_SIDED|95.0|-6.8|10.6||||||||10.6|-6.8|
72409119|NCT00727857|144326697|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|140.3||||0.0004||95.0|62.5|218.0|||ANCOVA||Mean Difference = Pioglitazone \& metformin - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||218.0|62.5|0.0004
72573486|NCT00123474|144673565|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority of 100 mg total daily dose relative to 140 mg total daily dose was deduced if the lower bound of the 95% CI for the difference was greater than or equal to -15%.|Risk Difference (RD)|-0.2|||||TWO_SIDED|95.0|-8.9|8.5||||||||8.5|-8.9|
72573487|NCT00123474|144673576|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority of the QD schedule relative to the BID schedule was deduced if the lower bound of the 95% CI for the MCyRRQD minus MCyRRBID difference was greater than or equal to -15%.|Risk Difference (RD)|1.8|||||TWO_SIDED|95.0|-11.7|15.3||||||6 Month Analysis||15.3|-11.7|
72409120|NCT00727857|144326697|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|142.3||||0.0006||95.0|61.3|223.3|||ANCOVA||Mean Difference = Pioglitazone - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||223.3|61.3|0.0006
72409121|NCT00727857|144326698|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3||||0.9922||95.0|-64.4|65.1|||ANCOVA||Mean Difference = Pioglitazone \& metformin - pioglitazone|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||65.1|-64.4|0.9922
72409122|NCT00727857|144326698|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|111.7||||0.0004||95.0|49.7|173.7|||ANCOVA||Mean Difference = Pioglitazone \& metformin - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||173.7|49.7|0.0004
72409123|NCT00727857|144326698|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|111.4||||0.0008||95.0|46.8|175.9|||ANCOVA||Mean Difference = Pioglitazone - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||175.9|46.8|0.0008
72409124|NCT00727857|144326699|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.08||||0.0072||95.0|-1.86|-0.29|||ANCOVA||Mean Difference = Pioglitazone \& metformin - pioglitazone|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||-0.29|-1.86|0.0072
72573488|NCT00123474|144673576|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority of 100 mg QD Total Daily Dose relative to 140 mg QD Total Daily Dose was deduced if the lower bound of the 95% CI difference was greater than or equal to -15%.|Risk Difference (RD)|4.2|||||TWO_SIDED|95.0|-9.3|17.6||||||6 Month Analysis||17.6|-9.3|
72573489|NCT00123474|144673576|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority of the QD schedule relative to the BID schedule was deduced if the lower bound of the 95% CI for the MCyRRQD minus MCyRRBID difference was greater than or equal to -15%.|Risk Difference (RD)|1.4|||||TWO_SIDED|95.0|-11.2|14.1||||||24 Month Analysis||14.1|-11.2|
72573490|NCT00123474|144673576|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority of 100 mg QD Total Daily Dose relative to 140 mg QD Total Daily Dose was deduced if the lower bound of the 95% CI difference was greater than or equal to -15%.|Risk Difference (RD)|1.4|||||TWO_SIDED|95.0|-11.2|14.1||||||24 Month Analysis||14.1|-11.2|
72573491|NCT01059344|144673586|SUPERIORITY_OR_OTHER|||||||0.069|||||||Chi-squared|||||||0.069
72573492|NCT01059344|144673587|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
72573493|NCT01059344|144673588|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
72573494|NCT01059344|144673589|SUPERIORITY|||||||0.01|||||||Chi-squared|||||||0.010
72573495|NCT01059344|144673590|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
72573496|NCT01059344|144673591|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
72573497|NCT01059344|144673592|SUPERIORITY|||||||0.011|||||||Chi-squared|||||||0.011
72573498|NCT01739348|144673593|SUPERIORITY||Difference in Least Squares Mean|0.2||||0.6287|TWO_SIDED|97.51|-0.9|1.3|||Longitudinal ANCOVA|||||1.3|-0.9|0.6287
72573499|NCT01739348|144673593|SUPERIORITY||Difference in Least Squares Mean|0.4||||0.4625|TWO_SIDED|97.51|-0.8|1.5|||Longitudinal ANCOVA|||||1.5|-0.8|0.4625
72573500|NCT01739348|144673594|SUPERIORITY||Difference in Least Squares Means|0.5||||0.4925|TWO_SIDED|97.51|-1.1|2.1|||Longitudinal ANCOVA|||||2.1|-1.1|0.4925
72573501|NCT01739348|144673594|SUPERIORITY||Difference in Least Squares Means|0.7||||0.3221|TWO_SIDED|97.51|-0.9|2.3|||Longitudinal ANCOVA|||||2.3|-0.9|0.3221
72573502|NCT01739348|144673601|SUPERIORITY||Difference in Least Squares Means|0.0||||0.8426|TWO_SIDED|97.51|-0.4|0.3|||Longitudinal ANCOVA|||||0.3|-0.4|0.8426
72573503|NCT01739348|144673601|SUPERIORITY||Difference in Least Squares Means|0.0||||0.8264|TWO_SIDED|97.51|-0.3|0.4|||Longitudinal ANCOVA|||||0.4|-0.3|0.8264
72573504|NCT01739348|144673602|SUPERIORITY||Difference in Least Squares Means|-0.6||||0.0005|TWO_SIDED|97.51|-1.0|-0.2|||Longitudinal ANCOVA|||||-0.2|-1.0|0.0005
72573505|NCT01739348|144673602|SUPERIORITY||Difference in Least Squares Means|-0.7||||0.0002|TWO_SIDED|97.51|-1.1|-0.3|||Longitudinal ANCOVA|||||-0.3|-1.1|0.0002
72573506|NCT01739348|144673603|SUPERIORITY||Ratio of Fold Change from Baseline|0.95||||0.2138|TWO_SIDED|95.0|0.87|1.04|||Longitudinal ANCOVA|||||1.04|0.87|0.2138
72573507|NCT01739348|144673603|SUPERIORITY||Ratio of Fold Change from Baseline|0.97||||0.433|TWO_SIDED|95.0|0.9|1.05|||Longitudinal ANCOVA|||||1.05|0.90|0.4330
72573508|NCT01739348|144673604|SUPERIORITY||Difference in Least Squares Means|-0.03||||0.0066|TWO_SIDED|95.0|-0.05|0.0|||Longitudinal ANCOVA|||||0.00|-0.05|0.0066
72573509|NCT01739348|144673604|SUPERIORITY||Difference in Least Squares Means|-0.04|||<|0.0001|TWO_SIDED|95.0|-0.06|-0.02|||Longitudinal ANCOVA|||||-0.02|-0.06|<0.0001
72573510|NCT01739348|144673606|SUPERIORITY||Difference in Least Squares Means|0.7||||0.2949|TWO_SIDED|95.0|-0.6|2.1|||Longitudinal ANCOVA|||||2.1|-0.6|0.2949
72409125|NCT00727857|144326699|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.34||||0.3682||95.0|-0.41|1.1|||ANCOVA||Mean Difference = Pioglitazone \& metformin - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||1.10|-0.41|0.3682
72573511|NCT01739348|144673606|SUPERIORITY||Difference in Least Squares Means|1.1||||0.1372|TWO_SIDED|95.0|-0.4|2.6|||Longitudinal ANCOVA|||||2.6|-0.4|0.1372
72573512|NCT01739348|144673607|SUPERIORITY||Difference in Least Squares Means|0.2||||0.4721|TWO_SIDED|95.0|-0.3|0.7|||Longitudinal ANCOVA|||||0.7|-0.3|0.4721
72409126|NCT00727857|144326699|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.42||||0.0004||95.0|0.64|2.2|||ANCOVA||Mean Difference = Pioglitazone - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||2.20|0.64|0.0004
72409127|NCT00727857|144326700|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.04||||0.1986||95.0|-0.02|0.1|||ANCOVA||Mean Difference = Pioglitazone \& metformin - pioglitazone|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||0.10|-0.02|0.1986
72409128|NCT00727857|144326700|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.04||||0.1487||95.0|-0.1|0.02|||ANCOVA||Mean Difference = Pioglitazone \& metformin - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||0.02|-0.10|0.1487
72573513|NCT01739348|144673607|SUPERIORITY||Difference in Least Squares Means|0.5||||0.0599|TWO_SIDED|95.0|0.0|1.0|||Longitudinal ANCOVA|||||1.0|0.0|0.0599
72573514|NCT01447420|144673620|SUPERIORITY_OR_OTHER|||||||0.0007|TWO_SIDED||||||Chi-squared|Participants without measurement at the end of the 24 week untreated follow-up period were considered as non-responders.||IL28B Genotypes (CC, CT or TT)||||0.0007
72573515|NCT01447420|144673623|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.68|||||TWO_SIDED|95.0|0.69|4.14|||||Odds Ratio for SVR estimated from the logistic regression model.|Anemia after the first month of treatment vs No anemia||4.14|0.69|
72573516|NCT01447420|144673623|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.86|||||TWO_SIDED|95.0|0.28|2.59|||||Odds Ratio for SVR estimated from the logistic regression model.|Anemia in the first month of treatment vs No anemia||2.59|0.28|
72573517|NCT01447420|144673623|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.45|||||TWO_SIDED|95.0|2.27|13.12|||||Odds Ratio for SVR estimated from the logistic regression model.|IL28B - CC vs CT||13.12|2.27|
72573518|NCT01447420|144673623|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.03|||||TWO_SIDED|95.0|1.19|13.61|||||Odds Ratio for SVR estimated from the logistic regression model.|IL28B - CC vs TT||13.61|1.19|
72573519|NCT04420273|144673629|OTHER||||||<|0.001|||||||McNemar|McNemar's chi-square with continuity correction||1-month survey||||<0.001
72573520|NCT04420273|144673629|OTHER||||||<|0.001|||||||McNemar|McNemar's chi-square with continuity correction||2- months||||<0.001
72573521|NCT04420273|144673629|OTHER||||||<|0.001|||||||McNemar|McNemar's chi-square with continuity correction||3-months||||<0.001
72573522|NCT04420273|144673630|OTHER||||||<|0.001|||||||Chi-squared|||||||<0.001
72573523|NCT04420273|144673631|OTHER||||||<|0.1|||||||Chi-squared|||||||< 0.1
72573524|NCT04420273|144673632|OTHER||||||<|0.001|||||||Chi-squared|||||||<0.001
72573525|NCT04420273|144673633|OTHER||||||<|0.001|||||||Chi-squared|||||||<0.001
72573526|NCT04420273|144673634|OTHER|||||||0.459|||||||Chi-squared|||||||0.459
72573527|NCT04420273|144673634|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
72573528|NCT04420273|144673635|OTHER||||||<|0.001|||||||Chi-squared|||||||<0.001
72573529|NCT02994940|144673647|SUPERIORITY||Hodges Lehman estimator|21.3||||0.127|TWO_SIDED|95.0|-2.5|44.2|||Wilcoxon (Mann-Whitney)|||||44.2|-2.5|0.127
72573530|NCT02994940|144673648|SUPERIORITY|||||||0.851|||||||Chi-squared|||||||0.851
72573531|NCT02994940|144673649|SUPERIORITY||Hodges Lehman estimator|2.0||||0.109|TWO_SIDED|95.0|-1.0|6.0|||Wilcoxon (Mann-Whitney)|||||6.0|-1.0|0.109
72573532|NCT02994940|144673650|SUPERIORITY||Hodges Lehman estimator|7.0||||0.0001|TWO_SIDED|95.0|4.0|8.0|||Wilcoxon (Mann-Whitney)|||||8.0|4.0|0.0001
72573533|NCT03233230|144673651|SUPERIORITY||Odds Ratio (OR)|1.48||||0.1746|TWO_SIDED|95.0|0.84|2.61|||Regression, Logistic|||||2.61|0.84|0.1746
72409129|NCT00727857|144326700|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.08||||0.0076||95.0|-0.14|-0.02|||ANCOVA||Mean Difference = Pioglitazone - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||-0.02|-0.14|0.0076
72537168|NCT01569074|144605091|SUPERIORITY_OR_OTHER||Treatment difference|0.25||||0.881|TWO_SIDED|80.0|-1.91|2.41|||ANCOVA|Including terms for baseline as a continuous covariate and treatment and pooled country as factors.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or following receipt of any parenteral steroids, or for patients with no post baseline data. Subjects who prematurely withdrew due to project closure have no imputation applied.||2.41|-1.91|0.881
72537169|NCT01569074|144605091|SUPERIORITY_OR_OTHER||Treatment difference|-0.42||||0.806|TWO_SIDED|80.0|-2.64|1.8|||ANCOVA|Includes terms for baseline as a continuous covariate and treatment and pooled country as factors.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or following receipt of any parenteral steroids, or for patients with no post baseline data. Subjects who prematurely withdrew due to project closure have no imputation applied.||1.80|-2.64|0.806
72537170|NCT01569074|144605091|SUPERIORITY_OR_OTHER||Treatment difference|1.03||||0.548|TWO_SIDED|80.0|-1.17|3.23|||ANCOVA|Includes terms for baseline as a continuous covariate and treatment and pooled country as factors.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or following receipt of any parenteral steroids, or for patients with no post baseline data. Subjects who prematurely withdrew due to project closure have no imputation applied.||3.23|-1.17|0.548
72537171|NCT01569074|144605092|SUPERIORITY_OR_OTHER||Treatment difference|3.12||||0.139|TWO_SIDED|80.0|0.42|5.82|||ANCOVA|Including terms for baseline as a continuous covariate and treatment and pooled country as factors.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or following receipt of any parenteral steroids, or for patients with no post baseline data. Subjects who prematurely withdrew due to project closure have no imputation applied.||5.82|0.42|0.139
72537172|NCT01569074|144605092|SUPERIORITY_OR_OTHER||Treatment difference|2.47||||0.223|TWO_SIDED|80.0|-0.13|5.07|||ANCOVA|Including terms for baseline as a continuous covariate and treatment and pooled country as factors.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or following receipt of any parenteral steroids, or for patients with no post baseline data. Subjects who prematurely withdrew due to project closure have no imputation applied.||5.07|-0.13|0.223
72537173|NCT01569074|144605092|SUPERIORITY_OR_OTHER||Treatment difference|-1.63||||0.432|TWO_SIDED|80.0|-4.3|1.04|||ANCOVA|Includes terms for baseline as a continuous covariate and treatment and pooled country as factors.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or following receipt of any parenteral steroids, or for patients with no post baseline data. Subjects who prematurely withdrew due to project closure have no imputation applied.||1.04|-4.30|0.432
72537174|NCT01569074|144605092|SUPERIORITY_OR_OTHER||Treatment difference|1.45||||0.481|TWO_SIDED|80.0|-1.19|4.09|||ANCOVA|Includes terms for baseline as a continuous covariate and treatment and pooled country as factors.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or following receipt of any parenteral steroids, or for patients with no post baseline data. Subjects who prematurely withdrew due to project closure have no imputation applied.||4.09|-1.19|0.481
72537175|NCT02723786|144605093|OTHER||||||||||||||||||The proportion of participants with DGF was 0.57, highest Posterior Density (HPD) 95% Credible interval (CI) (0.25,0.90). The posterior probability for the proportion of participants with DGF \<30% was 0.07 (HPD 95% CI \[0.00,1.00\]). The posterior probability for the proportion of participants with DGF \<50% was 0.34 (HPD 95% CI \[0.00,1.00\]).|||
72537176|NCT03123120|144605112|OTHER||Risk Difference (RD)|-0.232|||||TWO_SIDED|95.0|-0.568|0.118|||||Risk difference was calculated as the observed proportion of response from Spesolimab minus the one from Placebo. Newcombe method was used in the calculation of the 95% confidence interval around the risk difference.|||0.118|-0.568|
72537177|NCT03123120|144605113|OTHER||Risk Difference (RD)|-0.054|||||TWO_SIDED|95.0|-0.404|0.21|||||Risk difference was calculated as the observed proportion of response from Spesolimab minus the one from Placebo. Newcombe method was used in the calculation of the 95% confidence interval around the risk difference.|||0.210|-0.404|
72537178|NCT03123120|144605114|OTHER||Risk Difference (RD)|-0.286|||||TWO_SIDED|95.0|-0.602|0.101|||||Risk difference was calculated as the observed proportion of response from Spesolimab minus the one from Placebo. Newcombe method was used in the calculation of the 95% confidence interval around the risk difference.|||0.101|-0.602|
72573534|NCT03233230|144673651|SUPERIORITY||Odds Ratio (OR)|1.06||||0.8283|TWO_SIDED|95.0|0.61|1.87|||Regression, Logistic|||||1.87|0.61|0.8283
72573535|NCT03233230|144673651|SUPERIORITY||Odds Ratio (OR)|1.55||||0.1298|TWO_SIDED|95.0|0.88|2.74|||Regression, Logistic|||||2.74|0.88|0.1298
72573536|NCT03233230|144673652|SUPERIORITY||Response rate difference|0.13||||0.0077|TWO_SIDED|95.0|0.04|0.23|||Cochran-Mantel-Haenszel|||||0.23|0.04|0.0077
72573537|NCT03233230|144673652|SUPERIORITY||Response rate difference|0.17||||0.0013|TWO_SIDED|95.0|0.07|0.27|||Cochran-Mantel-Haenszel|||||0.27|0.07|0.0013
72409130|NCT00727857|144326701|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.31||||0.2384||95.0|-0.21|0.83|||ANCOVA||Mean Difference = Pioglitazone \& metformin - pioglitazone|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||0.83|-0.21|0.2384
72409131|NCT00727857|144326701|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.19||||0.4617||95.0|-0.69|0.31|||ANCOVA||Mean Difference = Pioglitazone \& metformin - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||0.31|-0.69|0.4617
72573538|NCT03233230|144673652|SUPERIORITY||Response rate difference|0.13||||0.008|TWO_SIDED|95.0|0.04|0.23|||Cochran-Mantel-Haenszel|||||0.23|0.04|0.0080
72573539|NCT03233230|144673653|SUPERIORITY||Response rate difference|0.09||||0.0056|TWO_SIDED|95.0|0.03|0.17|||Cochran-Mantel-Haenszel|||||0.17|0.03|0.0056
72573540|NCT03233230|144673653|SUPERIORITY||Response rate difference|0.09||||0.005|TWO_SIDED|95.0|0.03|0.17|||Cochran-Mantel-Haenszel|||||0.17|0.03|0.0050
72573541|NCT03233230|144673653|SUPERIORITY||Response rate difference|0.09||||0.0053|TWO_SIDED|95.0|0.03|0.17|||Cochran-Mantel-Haenszel|||||0.17|0.03|0.0053
72409132|NCT00727857|144326701|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5||||0.0593||95.0|-1.02|0.02|||ANCOVA||Mean Difference = Pioglitazone - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||0.02|-1.02|0.0593
72409133|NCT00727857|144326702|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.28||||0.5044||95.0|-0.54|1.1|||ANCOVA||Mean Difference = Pioglitazone \& metformin - pioglitazone|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||1.10|-0.54|0.5044
72409134|NCT00727857|144326702|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.43||||0.0004||95.0|-2.22|-0.64|||ANCOVA||Mean Difference = Pioglitazone \& metformin - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||-0.64|-2.22|0.0004
72537179|NCT03123120|144605115|OTHER||Risk Difference (RD)|0.143|||||TWO_SIDED|95.0|-0.197|0.399|||||Risk difference was calculated as the observed proportion of response from Spesolimab minus the one from Placebo. Newcombe method was used in the calculation of the 95% confidence interval around the risk difference.|||0.399|-0.197|
72537180|NCT00203892|144605117|SUPERIORITY_OR_OTHER|||||||0.028||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.028
72537181|NCT00203892|144605118|SUPERIORITY_OR_OTHER||||||>|0.99||95.0|||||Fisher Exact|||||||>0.99
72537182|NCT00806416|144605119|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Administration of a 70 mg alendronate/2800 IU vitamin D3 final market combination tablet and the 70 mg alendronate market tablet, the GMR of the combination tablet/alendronate only tablet are contained within \[0.80,1.25\].|Least square mean ratio|1.03||||||90.0|0.91|1.17||||||If the true geometric mean ratio (GMR) for total urinary excretion of alendronate of 70 mg alendronate/vitamin D3 combination tablet with respect to alendronate alone is 1.00 then a sample size =208 provided 99% probability of yielding a 90% CI for the total urinary excretion GMR within the interval of \[0.80, 1.25\]. These calculations were based on the observed-pooled within-subject standard deviation (log scale) of 0.521 obtained from earlier Phase 1 studies.||1.17|0.91|
72537183|NCT00806416|144605120|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Administration of a 70 mg alendronate/2800 IU vitamin D3 final market combination tablet and a tablet containing 2800 IU vitamin D3, the geometric mean ratio (GMR) for AUC0-120 hr and Cmax, corrected for predose concentration, of the combination tablet/2800 IU vitamin D3 only tablet were contained within \[0.80,1.25\].|Least square mean ratio for AUC0-120 hr|0.88||||||90.0|0.81|0.95||||||If the true GMRs for AUC and Cmax for 70 mg alendronate/vitamin D3 combination tablet with respect to 2800 IU vitamin D3 alone were 1.00 then a sample size=28 provided \>99% probability of yielding a 90% CI for both AUC(0-120 hr) and Cmax GMRs within the interval of \[0.80, 1.25\]. The within-subject standard deviation of 0.14 ln ng•hr/mL for AUC(0-120 hr) (ng•hr/mL) and 0.14 ng/mL for Cmax was obtained from another phase 1 study.||0.95|0.81|
72537184|NCT00806416|144605121|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Administration of a 70 mg alendronate/2800 IU vitamin D3 final market combination tablet and a tablet containing 2800 IU vitamin D3, the geometric mean ratio (GMR) for AUC0-120 hr and Cmax, corrected for predose concentration, of the combination tablet/2800 IU vitamin D3 only tablet were contained within \[0.80,1.25\].|least-squares mean for Cmax|0.89||||||90.0|0.84|0.95||||||If the true GMR ratios for AUC and Cmax for 70 mg alendronate/vitamin D3 combination tablet with respect to 2800 IU vitamin D3 alone were 1.00 then a sample of N=28 provided \>99% probability of yielding a 90% CI for both AUC0-120 hr and Cmax GMRs within the interval of \[0.80, 1.25\]. The within-subject standard deviation of 0.14 ln ng•hr/mL for AUC0-120 hr (ng•hr/mL) and 0.14 ng/mL for Cmax was obtained from another phase 1 study.||0.95|0.84|
72537185|NCT02701049|144605128|OTHER|Among 109,994 patients who entered the ED during Mode 1, 19,742 had SOGI collected (18%). Among 88,143 patients who entered the ED during Mode 2, 3,630 had SOGI collected (4%).||||||||||||||||Historical controls included all patients entering participating EDs as identified by the Electronic Health Record.|Results were compared to historical control population from an electronic health record database, no other data were collected for these participants.|||
72537186|NCT01610284|144605130|OTHER|Comparison of progression-free survival (PFS) (based on local investigator assessment) between the two treatment groups using a stratified log-rank test at one-sided 2.5% level of significance|Hazard Ratio (HR)|0.78|||<|0.001|TWO_SIDED|95.0|0.67|0.89|||Log Rank|||FAS-Full population||0.89|0.67|<0.001
72537187|NCT01610284|144605130|OTHER|Comparison of progression-free survival (PFS) (based on local investigator assessment) between the two treatment groups using a stratified log-rank test at one-sided 2.5% level of significance|Hazard Ratio (HR)|0.8||||0.003|TWO_SIDED|95.0|0.68|0.94|||Log Rank|||FAS-Main cohort||0.94|0.68|0.003
72537188|NCT01610284|144605130|OTHER|Comparison of progression-free survival (PFS) (based on local investigator assessment) between the two treatment groups using a stratified log-rank test at one-sided 2.5% level of significance|Hazard Ratio (HR)|0.76||||0.015|TWO_SIDED|95.0|0.6|0.97|||Log Rank|||FAS-PI3K pathway activated||0.97|0.60|0.015
72409135|NCT00727857|144326702|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.71|||<|0.0001||95.0|-2.53|-0.89|||ANCOVA||Mean Difference = Pioglitazone - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||-0.89|-2.53|<0.0001
72409136|NCT00727857|144326703|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.63||||0.0017||95.0|-2.64|-0.62|||ANCOVA||Mean Difference = Pioglitazone \& metformin - pioglitazone|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||-0.62|-2.64|0.0017
72409137|NCT00727857|144326703|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.97|||<|0.0001||95.0|1.01|2.94|||ANCOVA||Mean Difference = Pioglitazone \& metformin - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||2.94|1.01|<0.0001
72409138|NCT00727857|144326703|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.6|||<|0.0001||95.0|2.59|4.61|||ANCOVA||Mean Difference = Pioglitazone - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||4.61|2.59|<0.0001
72409139|NCT00727857|144326704|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.76||||0.2466||95.0|-2.61|10.14|||ANCOVA||Mean Difference = Pioglitazone \& metformin - pioglitazone|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||10.14|-2.61|0.2466
72573542|NCT03233230|144673654|SUPERIORITY||Response rate difference|0.09||||0.1419|TWO_SIDED|95.0|-0.03|0.21|||Cochran-Mantel-Haenszel|||||0.21|-0.03|0.1419
72537189|NCT01610284|144605130|OTHER|Comparison of progression-free survival (PFS) (based on local investigator assessment) between the two treatment groups using a stratified log-rank test at one-sided 2.5% level of significance|Hazard Ratio (HR)|0.83|||||TWO_SIDED|95.0|0.67|1.03||||||FAS-PI3K pathway non-activated||1.03|0.67|
72537190|NCT01610284|144605130|OTHER|Comparison of progression-free survival (PFS) (based on local investigator assessment) between the two treatment groups using a stratified log-rank test at one-sided 2.5% level of significance|Hazard Ratio (HR)|0.7|||||TWO_SIDED|95.0|0.52|0.94||||||FAS-PI3K pathway unknown||0.94|0.52|
72537191|NCT01610284|144605131|OTHER|Comparison of overall survival (OS) (based on local investigator assessment) between the two treatment groups using a stratified log-rank test at one-sided 2.5% level of significance|Hazard Ratio (HR)|0.87||||0.045|TWO_SIDED|95.0|0.74|1.02|||Log Rank|||FAS-Full population||1.02|0.74|0.045
72537192|NCT01610284|144605131|OTHER|Comparison of overall survival (OS) (based on local investigator assessment) between the two treatment groups using a stratified log-rank test at one-sided 2.5% level of significance|Hazard Ratio (HR)|0.91||||0.144|TWO_SIDED|95.0|0.75|1.09|||Log Rank|||FAS-Main cohort||1.09|0.75|0.144
72537193|NCT01610284|144605131|OTHER|Comparison of overall survival (OS) (based on local investigator assessment) between the two treatment groups using a stratified log-rank test at one-sided 2.5% level of significance|Hazard Ratio (HR)|0.81|||||TWO_SIDED|95.0|0.61|1.08||||||FAS-PI3K pathway activated||1.08|0.61|
72537194|NCT01610284|144605131|OTHER|Comparison of overall survival (OS) (based on local investigator assessment) between the two treatment groups using a stratified log-rank test at one-sided 2.5% level of significance|Hazard Ratio (HR)|0.98|||||TWO_SIDED|95.0|0.77|1.24||||||FAS-PI3K pathway non-activated||1.24|0.77|
72537195|NCT01610284|144605131|OTHER|Comparison of overall survival (OS) (based on local investigator assessment) between the two treatment groups using a stratified log-rank test at one-sided 2.5% level of significance|Hazard Ratio (HR)|0.74|||||TWO_SIDED|95.0|0.52|1.06||||||FAS-PI3K pathway unknown||1.06|0.52|
72537196|NCT04035694|144605139|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|-0.08|STANDARD_ERROR_OF_MEAN|0.08||0.41|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.41
72537197|NCT04035694|144605140|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|-0.16|STANDARD_ERROR_OF_MEAN|0.1||0.11|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||.11
72537198|NCT04035694|144605141|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|-0.06|STANDARD_ERROR_OF_MEAN|0.09||0.54|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.54
72537199|NCT04035694|144605142|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|-0.12|STANDARD_ERROR_OF_MEAN|0.11||0.38|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.38
72537200|NCT04035694|144605143|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|0.04|STANDARD_ERROR_OF_MEAN|0.07||0.56|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.56
72573543|NCT03233230|144673654|SUPERIORITY||Response rate difference|0.07||||0.2202|TWO_SIDED|95.0|-0.05|0.19|||Cochran-Mantel-Haenszel|||||0.19|-0.05|0.2202
72573544|NCT03233230|144673654|SUPERIORITY||Response rate difference|0.07||||0.2328|TWO_SIDED|95.0|-0.05|0.19|||Cochran-Mantel-Haenszel|||||0.19|-0.05|0.2328
72573545|NCT03233230|144673655|SUPERIORITY||Response rate difference|0.06||||0.1232|TWO_SIDED|95.0|-0.02|0.15|||Cochran-Mantel-Haenszel|||||0.15|-0.02|0.1232
72409140|NCT00727857|144326704|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.52||||0.0063||95.0|-14.63|-2.42|||ANCOVA||Mean Difference = Pioglitazone \& metformin - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||-2.42|-14.63|0.0063
72409141|NCT00727857|144326704|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.29||||0.0002||95.0|-18.65|-5.93|||ANCOVA||Mean Difference = Pioglitazone - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||-5.93|-18.65|0.0002
72409142|NCT00727857|144326705|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.15||||0.2069||95.0|-2.93|0.64|||ANCOVA||Mean Difference = Pioglitazone \& metformin - pioglitazone|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||0.64|-2.93|0.2069
72409143|NCT00727857|144326705|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.44||||0.0052||95.0|0.73|4.15|||ANCOVA||Mean Difference = Pioglitazone \& metformin - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||4.15|0.73|0.0052
72573546|NCT03233230|144673655|SUPERIORITY||Response rate difference|0.05||||0.1725|TWO_SIDED|95.0|-0.03|0.14|||Cochran-Mantel-Haenszel|||||0.14|-0.03|0.1725
72573547|NCT03233230|144673655|SUPERIORITY||Response rate difference|0.05||||0.1795|TWO_SIDED|95.0|-0.03|0.13|||Cochran-Mantel-Haenszel|||||0.13|-0.03|0.1795
72573548|NCT03233230|144673663|SUPERIORITY||Response rate difference|0.0|||||TWO_SIDED|95.0|-0.04|0.04||||||||0.04|-0.04|
72573549|NCT03233230|144673663|SUPERIORITY||Response rate difference|0.01|||||TWO_SIDED|95.0|-0.03|0.06||||||||0.06|-0.03|
72573550|NCT03233230|144673663|SUPERIORITY||Response rate difference|0.03|||||TWO_SIDED|95.0|-0.01|0.09||||||||0.09|-0.01|
72573551|NCT03233230|144673664|SUPERIORITY||Response rate difference|0.03|||||TWO_SIDED|95.0|-0.02|0.09||||||||0.09|-0.02|
72409144|NCT00727857|144326705|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.59|||<|0.0001||95.0|1.81|5.36|||ANCOVA||Mean Difference = Pioglitazone - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||5.36|1.81|<0.0001
72409145|NCT00727857|144326706|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.26||||0.609||95.0|-1.28|0.75|||ANCOVA||Mean Difference = Pioglitazone \& metformin - pioglitazone|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||0.75|-1.28|0.6090
72409146|NCT00727857|144326706|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.25||||0.6169||95.0|-1.22|0.72|||ANCOVA||Mean Difference = Pioglitazone \& metformin - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||0.72|-1.22|0.6169
72409147|NCT00727857|144326706|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.02||||0.974||95.0|-0.99|1.03|||ANCOVA||Mean Difference = Pioglitazone - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||1.03|-0.99|0.9740
72409148|NCT00727857|144326707|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.06||||0.615||95.0|-3.09|5.21|||ANCOVA||Mean Difference = Pioglitazone \& metformin - pioglitazone|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||5.21|-3.09|0.6150
72409149|NCT00727857|144326707|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.41||||0.2346||95.0|-6.38|1.57|||ANCOVA||Mean Difference = Pioglitazone \& metformin - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||1.57|-6.38|0.2346
72409150|NCT00727857|144326707|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.47||||0.1001||95.0|-7.61|0.67|||ANCOVA||Mean Difference = Pioglitazone - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||0.67|-7.61|0.1001
72573552|NCT03233230|144673664|SUPERIORITY||Response rate difference|0.05|||||TWO_SIDED|95.0|0.0|0.12||||||||0.12|-0.00|
72573553|NCT03233230|144673664|SUPERIORITY||Response rate difference|0.02|||||TWO_SIDED|95.0|-0.03|0.08||||||||0.08|-0.03|
72573554|NCT03233230|144673665|SUPERIORITY||Response rate difference|0.03|||||TWO_SIDED|95.0|-0.01|0.09||||||||0.09|-0.01|
72573555|NCT03233230|144673665|SUPERIORITY||Response rate difference|0.04|||||TWO_SIDED|95.0|0.0|0.1||||||||0.10|0.00|
72573556|NCT03233230|144673665|SUPERIORITY||Response rate difference|0.03|||||TWO_SIDED|95.0|-0.01|0.09||||||||0.09|-0.01|
72573557|NCT03233230|144673666|SUPERIORITY||Response rate difference|0.11|||||TWO_SIDED|95.0|-0.03|0.24||||||||0.24|-0.03|
72573558|NCT03233230|144673666|SUPERIORITY||Response rate difference|0.12|||||TWO_SIDED|95.0|-0.02|0.25||||||||0.25|-0.02|
72573559|NCT03233230|144673666|SUPERIORITY||Response rate difference|0.18|||||TWO_SIDED|95.0|0.05|0.31||||||||0.31|0.05|
72573560|NCT01898650|144673715|SUPERIORITY|||||||0.004||||||no adjustments for multiple comparisons were made. the threshold for significance was set a priori at 0.05.|t-test, 1 sided|||Null hypothesis was that blood flow would be equivalent on the unaffected and affected sides.||||0.004
72576780|NCT00261443|144680651|SUPERIORITY_OR_OTHER_LEGACY||Difference|-1.39||||0.017|TWO_SIDED|95.0|-2.52|-0.25||Mean change from baseline: ANOVA model, controlling for treatment, mood stabilizer, index mood episode, and baseline value. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 16 Comparison||-0.25|-2.52|0.017
72573561|NCT04135196|144673716|OTHER|||||||0.119|||||||Regression, Linear|||"The power analysis for the overall study was based on 12-month change in UD iBMC. The power calculation, based on pilot data, determined that 20 participants per group would have 80% power to detect a 1.0±1.1% change.~The null hypothesis was that change in UD iBMC was not proportional to strain magnitude. Raw change in iBMC was analyzed as the dependent variable in a linear regression model with coefficients representing contrasts between the two experimental groups and the control group."|"Overall model fit: R\^2=0.101, F=2.244, df1=2, df2=40, p=0.119~Contrast between the low strain magnitude group and the control group: B=0.015, Std. Error of estimate of B=0.007, Beta=0.374, t=2.114, p=0.041, 95% CI of B: \[0.001, 0.030\]~Contrast between the high strain magnitude group and the control group: B=0.009, Std. Error of estimate of B=0.007, Beta=0.221, t=1.247, p=0.220, 95% CI of B: \[-0.005, 0.022\]"|||0.119
72573562|NCT04135196|144673716|OTHER||||||<|0.01|||||||Regression, Linear|||The null hypothesis was that change in UD iBMC was not proportional to strain rate. Raw change in iBMC was analyzed as the dependent variable in a linear regression model with coefficients representing contrasts between the two experimental groups and the control group.|"Overall model fit: R\^2=0.438, F=12.836, df1=2, df2=33, p=\<0.001~Contrast between the low strain rate group and the control group: B=0.036, Std. Error of estimate of B=0.009, Beta=0.599, t=4.050, p=\<0.001, 95% CI of B: \[0.018, 0.055\]~Contrast between the high strain rate group and the control group: B=0.041, Std. Error of estimate of B=0.009, Beta=0.678, t=4.589, p=\<0.001, 95% CI of B: \[0.023, 0.060\]"|||<0.01
72573563|NCT04135196|144673717|OTHER|||||||0.809|||||||Regression, Linear|||The null hypothesis was that change in UD cBMC was not proportional to strain magnitude. Raw change in cBMC was analyzed as the dependent variable in a linear regression model with coefficients representing contrasts between the two experimental groups and the control group.|"Overall model fit: R\^2=0.011, F=0.213, df1=2, df2=40, p=0.809~Contrast between the low strain magnitude group and the control group: B=0.001, Std. Error of estimate of B=0.006, Beta=0.039, t=0.209, p=0.836, 95% CI of B: \[-0.012, 0.014\]~Contrast between the high strain magnitude group and the control group: B=-0.002, Std. Error of estimate of B=0.006, Beta=-0.077, t=-0.412, p=0.682, 95% CI of B: \[-0.015, 0.010\]"|||0.809
72573564|NCT04135196|144673717|OTHER|||||||0.155|||||||Regression, Linear|||The null hypothesis was that change in UD cBMC was not proportional to strain rate. Raw change in cBMC was analyzed as the dependent variable in a linear regression model with coefficients representing contrasts between the two experimental groups and the control group.|"Overall model fit: R\^2=0.107, F=1.971, df1=2, df2=33, p=0.155~Contrast between the low strain rate group and the control group: B=0.012, Std. Error of estimate of B=0.008, Beta=0.284, t=1.526, p=0.137, 95% CI of B: \[-0.004, 0.027\]~Contrast between the high strain rate group and the control group: B=0.014, Std. Error of estimate of B=0.008, Beta=0.342, t=1.837, p=0.075, 95% CI of B: \[-0.002, 0.030\]"|||0.155
72573565|NCT04135196|144673718|OTHER|||||||0.991|||||||Regression, Linear|||The null hypothesis was that change in UD ecBMC was not proportional to strain magnitude. Raw change in ecBMC was analyzed as the dependent variable in a linear regression model with coefficients representing contrasts between the two experimental groups and the control group.|"Overall model fit: R\^2=\<0.001, F=0.009, df1=2, df2=40, p=0.991~Contrast between the low strain magnitude group and the control group: B=0.001, Std. Error of estimate of B=0.009, Beta=0.025, t=0.133, p=0.894, 95% CI of B: \[-0.016, 0.018\]~Contrast between the high strain magnitude group and the control group: B=0.001, Std. Error of estimate of B=0.008, Beta=0.012, t=0.063, p=0.950, 95% CI of B: \[-0.016, 0.017\]"|||0.991
72573566|NCT04135196|144673718|OTHER|||||||0.018|||||||Regression, Linear|||The null hypothesis was that change in UD ecBMC was not proportional to strain rate. Raw change in ecBMC was analyzed as the dependent variable in a linear regression model with coefficients representing contrasts between the two experimental groups and the control group.|"Overall model fit: R\^2=0.216, F=4.548, df1=2, df2=33, p=0.018~Contrast between the low strain rate group and the control group: B=0.029, Std. Error of estimate of B=0.011, Beta=0.455, t=2.607, p=0.014, 95% CI of B: \[0.006, 0.052\]~Contrast between the high strain rate group and the control group: B=0.029, Std. Error of estimate of B=0.011, Beta=0.447, t=2.563, p=0.015, 95% CI of B: \[0.006, 0.052\]"|||0.018
72573567|NCT04135196|144673719|OTHER|||||||0.153|||||||Regression, Linear|||The null hypothesis was that change in UD tBMC was not proportional to strain magnitude. Raw change in tBMC was analyzed as the dependent variable in a linear regression model with coefficients representing contrasts between the two experimental groups and the control group.|"Overall model fit: R\^2=0.090, F=1.968, df1=2, df2=40, p=0.153~Contrast between the low strain magnitude group and the control group: B=0.007, Std. Error of estimate of B=0.003, Beta=0.352, t=1.973, p=0.055, 95% CI of B: \[0.000, 0.013\]~Contrast between the high strain magnitude group and the control group: B=0.003, Std. Error of estimate of B=0.003, Beta=0.156, t=0.874, p=0.387, 95% CI of B: \[-0.004, 0.009\]"|||0.153
72573568|NCT04135196|144673719|OTHER|||||||0.001|||||||Regression, Linear|||The null hypothesis was that change in UD tBMC was not proportional to strain rate. Raw change in tBMC was analyzed as the dependent variable in a linear regression model with coefficients representing contrasts between the two experimental groups and the control group.|"Overall model fit: R\^2=0.331, F=8.152, df1=2, df2=33, p=0.001~Contrast between the low strain rate group and the control group: B=0.012, Std. Error of estimate of B=0.004, Beta=0.473, t=2.930, p=0.006, 95% CI of B: \[0.004, 0.020\]~Contrast between the high strain rate group and the control group: B=0.016, Std. Error of estimate of B=0.004, Beta=0.617, t=3.828, p=0.001, 95% CI of B: \[0.008, 0.025\]"|||0.001
72537201|NCT04035694|144605144|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|-0.14|STANDARD_ERROR_OF_MEAN|0.08||0.09|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.09
72537202|NCT04035694|144605145|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|0.07|STANDARD_ERROR_OF_MEAN|0.08||0.4|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.40
72409151|NCT00727857|144326708|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.86||||0.1217||95.0|-0.76|6.48|||ANCOVA||Mean Difference = Pioglitazone \& metformin - pioglitazone|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||6.48|-0.76|0.1217
72409152|NCT00727857|144326708|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.9||||0.0009||95.0|-9.36|-2.44|||ANCOVA||Mean Difference = Pioglitazone \& metformin - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||-2.44|-9.36|0.0009
72409153|NCT00727857|144326708|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.76|||<|0.0001||95.0|-12.36|-5.16|||ANCOVA||Mean Difference = Pioglitazone - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||-5.16|-12.36|<0.0001
72409154|NCT03282955|144326782|NON_INFERIORITY|Non-inferiority margin= 1.151||||||0.025|||||||t-test, 1 sided|||||||0.025
72537203|NCT04035694|144605146|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|-0.03|STANDARD_ERROR_OF_MEAN|0.09||0.74|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.74
72537204|NCT04035694|144605147|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|0.03|STANDARD_ERROR_OF_MEAN|0.07||0.66|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.66
72537205|NCT04035694|144605148|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|0.03|STANDARD_ERROR_OF_MEAN|0.09||0.78|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.78
72573569|NCT04135196|144673720|OTHER|||||||0.84|||||||Regression, Linear|||The null hypothesis was that change in UD iBMD was not proportional to strain magnitude. Raw change in iBMD was analyzed as the dependent variable in a linear regression model with coefficients representing contrasts between the two experimental groups and the control group.|"Overall model fit: R\^2=0.009, F=0.176, df1=2, df2=40, p=0.840~Contrast between the low strain magnitude group and the control group: B=0.001, Std. Error of estimate of B=0.001, Beta=0.091, t=0.489, p=0.628, 95% CI of B: \[-0.002, 0.003\]~Contrast between the high strain magnitude group and the control group: B=0.001, Std. Error of estimate of B=0.001, Beta=0.101, t=0.544, p=0.589, 95% CI of B: \[-0.002, 0.003\]"|||0.840
72573570|NCT04135196|144673720|OTHER||||||<|0.001|||||||Regression, Linear|||The null hypothesis was that change in UD iBMD was not proportional to strain rate. Raw change in iBMD was analyzed as the dependent variable in a linear regression model with coefficients representing contrasts between the two experimental groups and the control group.|"Overall model fit: R\^2=0.563, F=21.225, df1=2, df2=33, p=\<0.001~Contrast between the low strain rate group and the control group: B=0.009, Std. Error of estimate of B=0.002, Beta=0.739, t=5.669, p=\<0.001, 95% CI of B: \[0.005, 0.012\]~Contrast between the high strain rate group and the control group: B=0.008, Std. Error of estimate of B=0.002, Beta=0.716, t=5.495, p=\<0.001, 95% CI of B: \[0.005, 0.012\]"|||<0.001
72573571|NCT04135196|144673721|OTHER|||||||0.202|||||||Regression, Linear|||The null hypothesis was that change in UD cBMD was not proportional to strain magnitude. Raw change in cBMD was analyzed as the dependent variable in a linear regression model with coefficients representing contrasts between the two experimental groups and the control group.|"Overall model fit: R\^2=0.077, F=1.665, df1=2, df2=40, p=0.202~Contrast between the low strain magnitude group and the control group: B=-0.005, Std. Error of estimate of B=0.003, Beta=-0.303, t=-1.689, p=0.099, 95% CI of B: \[-0.012, 0.001\]~Contrast between the high strain magnitude group and the control group: B=-0.004, Std. Error of estimate of B=0.003, Beta=-0.266, t=-1.484, p=0.146, 95% CI of B: \[-0.010, 0.002\]"|||0.202
72573572|NCT04135196|144673721|OTHER|||||||0.381|||||||Regression, Linear|||The null hypothesis was that change in UD cBMD was not proportional to strain rate. Raw change in cBMD was analyzed as the dependent variable in a linear regression model with coefficients representing contrasts between the two experimental groups and the control group.|"Overall model fit: R\^2=0.057, F=0.995, df1=2, df2=33, p=0.381~Contrast between the low strain rate group and the control group: B=0.004, Std. Error of estimate of B=0.003, Beta=0.254, t=1.327, p=0.194, 95% CI of B: \[-0.002, 0.011\]~Contrast between the high strain rate group and the control group: B=0.001, Std. Error of estimate of B=0.003, Beta=0.038, t=0.200, p=0.843, 95% CI of B: \[-0.006, 0.008\]"|||0.381
72576781|NCT00261443|144680651|SUPERIORITY_OR_OTHER_LEGACY||Difference|-1.91||||0.003|TWO_SIDED|95.0|-3.15|-0.68||Mean change from baseline: ANOVA model, controlling for treatment, mood stabilizer, index mood episode, and baseline value. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 20 Comparison||-0.68|-3.15|0.003
72409155|NCT04154631|144326814|SUPERIORITY||Time by treatment interaction coeff.|-10.91|||<|0.001|TWO_SIDED||||||Intent-to-treat, multilevel modeling|||Immediate TranS-C (Standard/Adapted combined) versus UC-DT on change in sleep disturbance from pre to post.||||<0.001
72409156|NCT04154631|144326814|SUPERIORITY||Coefficient of indirect effect|0.17||||0.95|TWO_SIDED|95.0|-4.62|4.95|||SEM|||Structural equation modeling (SEM) was used to test whether the relationship between treatment condition (Standard vs. Adapted) and sleep disturbance (PROMIS-SD) at post was mediated by provider ratings of acceptability (AIM) at post. The parameter of interest was the indirect effect.||4.95|-4.62|0.95
72537206|NCT04035694|144605149|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|0.1|STANDARD_ERROR_OF_MEAN|0.15||0.52|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.52
72537207|NCT04035694|144605150|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|0.07|STANDARD_ERROR_OF_MEAN|0.17||0.74|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.74
72537208|NCT04035694|144605151|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Median Difference (Net)|0.17|STANDARD_ERROR_OF_MEAN|0.13||0.21|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.21
72537209|NCT04035694|144605152|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|0.14|STANDARD_ERROR_OF_MEAN|0.13||0.27|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.27
72537210|NCT04035694|144605153|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Median Difference (Net)|-0.21|STANDARD_ERROR_OF_MEAN|0.07||0.01|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.01
72537211|NCT04035694|144605154|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|-0.15|STANDARD_ERROR_OF_MEAN|0.11||0.23|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.23
72537212|NCT04035694|144605155|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|-0.09|STANDARD_ERROR_OF_MEAN|0.05||0.05|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.05
72537213|NCT04035694|144605156|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|0.01|STANDARD_ERROR_OF_MEAN|0.11||0.95|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.95
72409157|NCT04154631|144326814|SUPERIORITY||Coefficient of indirect effect|0.09||||0.95|TWO_SIDED|95.0|-2.39|2.56|||SEM|||Structural equation modeling (SEM) was used to test whether the relationship between treatment condition (Standard vs. Adapted) and sleep disturbance (PROMIS-SD) at 6-month follow-up was mediated by provider ratings of acceptability (AIM) at post. The parameter of interest was the indirect effect.||2.56|-2.39|0.95
72409158|NCT04154631|144326814|SUPERIORITY||Coefficient of indirect effect|-0.16||||0.88|TWO_SIDED|95.0|-2.31|1.98|||SEM|||Structural equation modeling (SEM) was used to test whether the relationship between treatment condition (Standard vs. Adapted) and sleep disturbance (PROMIS-SD) at post was mediated by provider ratings of appropriateness (IAM) at post. The parameter of interest was the indirect effect.||1.98|-2.31|0.88
72409159|NCT04154631|144326814|SUPERIORITY||Coefficient of indirect effect|-0.13||||0.88|TWO_SIDED|95.0|-3.1|2.31|||SEM|||Structural equation modeling (SEM) was used to test whether the relationship between treatment condition (Standard vs. Adapted) and sleep disturbance (PROMIS-SD) at 6-month follow-up was mediated by provider ratings of appropriateness (IAM) at post. The parameter of interest was the indirect effect.||2.31|-3.10|0.88
72409160|NCT04154631|144326814|SUPERIORITY||Coefficient of indirect effect|-0.5||||0.79|TWO_SIDED|95.0|-2.18|1.66|||SEM|||Structural equation modeling (SEM) was used to test whether the relationship between treatment condition (Standard vs. Adapted) and sleep disturbance (PROMIS-SD) at post was mediated by provider ratings of feasibility (FIM) at post. The parameter of interest was the indirect effect.||1.66|-2.18|0.79
72537214|NCT04035694|144605157|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|0.99|STANDARD_ERROR_OF_MEAN|0.72||0.19|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.19
72537215|NCT04035694|144605158|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|-0.06|STANDARD_ERROR_OF_MEAN|0.59||0.92|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.92
72537216|NCT04035694|144605159|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Median Difference (Net)|-0.03|STANDARD_ERROR_OF_MEAN|0.13||0.81|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.81
72537217|NCT04035694|144605160|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|0.04|STANDARD_ERROR_OF_MEAN|0.16||0.81|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.81
72537218|NCT04035694|144605161|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|0.15|STANDARD_ERROR_OF_MEAN|0.1||0.14|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.14
72537219|NCT04035694|144605162|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|0.04|STANDARD_ERROR_OF_MEAN|0.15||0.82|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.82
72537220|NCT04035694|144605163|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Median Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|0.05||0.97|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.97
72537221|NCT04035694|144605164|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|-0.01|STANDARD_ERROR_OF_MEAN|0.09||0.89|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.89
72576782|NCT00261443|144680651|SUPERIORITY_OR_OTHER_LEGACY||Difference|-2.18|||<|0.001|TWO_SIDED|95.0|-3.47|-0.89||Mean change from baseline: ANOVA model, controlling for treatment, mood stabilizer, index mood episode, and baseline value. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 24 Comparison||-0.89|-3.47|<0.001
72409161|NCT04154631|144326814|SUPERIORITY||Coefficient of indirect effect|-0.26||||0.79|TWO_SIDED|95.0|-2.18|1.66|||SEM|||Structural equation modeling (SEM) was used to test whether the relationship between treatment condition (Standard vs. Adapted) and sleep disturbance (PROMIS-SD) at 6-month follow-up was mediated by provider ratings of feasibility (FIM) at post. The parameter of interest was the indirect effect.||1.66|-2.18|0.79
72576783|NCT00261443|144680651|SUPERIORITY_OR_OTHER_LEGACY||Difference|-2.62|||<|0.001|TWO_SIDED|95.0|-4.06|-1.19||Mean change from baseline: ANOVA model, controlling for treatment, mood stabilizer, index mood episode, and baseline value. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 28 Comparison||-1.19|-4.06|<0.001
72537222|NCT04035694|144605165|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|0.02|STANDARD_ERROR_OF_MEAN|0.05||0.69|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.69
72537223|NCT04035694|144605166|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|0.03|STANDARD_ERROR_OF_MEAN|0.06||0.63|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.63
72537224|NCT04035694|144605167|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|0.02|STANDARD_ERROR_OF_MEAN|0.07||0.79|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.79
72537225|NCT04035694|144605168|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|0.02|STANDARD_ERROR_OF_MEAN|0.16||0.93|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.93
72537226|NCT04035694|144605169|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|2.98|STANDARD_ERROR_OF_MEAN|2.18||0.2|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||.20
72537227|NCT04035694|144605170|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|5.0|STANDARD_ERROR_OF_MEAN|2.52||0.11|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.11
72537228|NCT04035694|144605171|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|-6.93|STANDARD_ERROR_OF_MEAN|2.38||0.01|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.01
72537229|NCT04035694|144605172|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|-2.24|STANDARD_ERROR_OF_MEAN|4.45||0.64|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.64
72537230|NCT04035694|144605173|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|-6.46|STANDARD_ERROR_OF_MEAN|2.53||0.03|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.03
72573573|NCT04135196|144673722|OTHER|||||||0.697|||||||Regression, Linear|||The null hypothesis was that change in UD ecBMD was not proportional to strain magnitude. Raw change in ecBMD was analyzed as the dependent variable in a linear regression model with coefficients representing contrasts between the two experimental groups and the control group.|"Overall model fit: R\^2=0.018, F=0.365, df1=2, df2=40, p=0.697~Contrast between the low strain magnitude group and the control group: B=-0.004, Std. Error of estimate of B=0.004, Beta=-0.158, t=-0.854, p=0.398, 95% CI of B: \[-0.012, 0.005\]~Contrast between the high strain magnitude group and the control group: B=-0.002, Std. Error of estimate of B=0.004, Beta=-0.078, t=-0.423, p=0.675, 95% CI of B: \[-0.010, 0.006\]"|||0.697
72573574|NCT04135196|144673722|OTHER|||||||0.018|||||||Regression, Linear|||The null hypothesis was that change in UD ecBMD was not proportional to strain rate. Raw change in ecBMD was analyzed as the dependent variable in a linear regression model with coefficients representing contrasts between the two experimental groups and the control group.|"Overall model fit: R\^2=0.215, F=4.516, df1=2, df2=33, p=0.018~Contrast between the low strain rate group and the control group: B=0.014, Std. Error of estimate of B=0.005, Beta=0.484, t=2.773, p=0.009, 95% CI of B: \[0.004, 0.0524\]~Contrast between the high strain rate group and the control group: B=0.012, Std. Error of estimate of B=0.005, Beta=0.406, t=2.325, p=0.026, 95% CI of B: \[0.001, 0.022\]"|||0.018
72573575|NCT04135196|144673723|OTHER|||||||0.073|||||||Regression, Linear|||The null hypothesis was that change in UD tBMD was not proportional to strain magnitude. Raw change in tBMD was analyzed as the dependent variable in a linear regression model with coefficients representing contrasts between the two experimental groups and the control group.|"Overall model fit: R\^2=0.123, F=2.799, df1=2, df2=40, p=0.073~Contrast between the low strain magnitude group and the control group: B=0.003, Std. Error of estimate of B=0.001, Beta=0.413, t=2.361, p=0.023, 95% CI of B: \[0.000, 0.006\]~Contrast between the high strain magnitude group and the control group: B=0.002, Std. Error of estimate of B=0.001, Beta=0.198, t=1.129, p=0.265, 95% CI of B: \[-0.001, 0.004\]"|||0.073
72573576|NCT04135196|144673723|OTHER||||||<|0.001|||||||Regression, Linear|||The null hypothesis was that change in UD tBMD was not proportional to strain rate. Raw change in tBMD was analyzed as the dependent variable in a linear regression model with coefficients representing contrasts between the two experimental groups and the control group.|"Overall model fit: R\^2=0.480, F=15.256, df1=2, df2=33, p=\<0.001~Contrast between the low strain rate group and the control group: B=0.008, Std. Error of estimate of B=0.002, Beta=0.590, t=4.153, p=\<0.001, 95% CI of B: \[0.004, 0.012\]~Contrast between the high strain rate group and the control group: B=0.001, Std. Error of estimate of B=0.002, Beta=0.734, t=5.164, p=\<0.001, 95% CI of B: \[0.006, 0.014\]"|||<0.001
72409162|NCT04154631|144326815|SUPERIORITY||time by treatment interaction coeff.|-0.03||||0.77|TWO_SIDED||||||Intent-to-treat, multilevel modeling|||Treatment effect (Standard versus Adapted TranS-C) on change in Acceptability Intervention Measure (AIM) from baseline (post-training) to post-treatment.||||0.77
72573577|NCT04135196|144673724|OTHER|||||||0.101|||||||Regression, Linear|||The null hypothesis was that change in UD iBV was not proportional to strain magnitude. Raw change in iBV was analyzed as the dependent variable in a linear regression model with coefficients representing contrasts between the two experimental groups and the control group.|"Overall model fit: R\^2=0.108, F=2.428, df1=2, df2=40, p=0.101~Contrast between the low strain magnitude group and the control group: B=0.053, Std. Error of estimate of B=0.024, Beta=0.388, t=2.200, p=0.034, 95% CI of B: \[0.004, 0.101\]~Contrast between the high strain magnitude group and the control group: B=0.029, Std. Error of estimate of B=0.022, Beta=0.226, t=1.280, p=0.208, 95% CI of B: \[-0.017, 0.074\]"|||0.101
72573578|NCT04135196|144673724|OTHER|||||||0.344|||||||Regression, Linear|||The null hypothesis was that change in UD iBV was not proportional to strain rate. Raw change in iBV was analyzed as the dependent variable in a linear regression model with coefficients representing contrasts between the two experimental groups and the control group.|"Overall model fit: R\^2=0.063, F=01.103, df1=2, df2=33, p=0.344~Contrast between the low strain rate group and the control group: B=0.015, Std. Error of estimate of B=0.025, Beta=0.113, t=0.595, p=0.556, 95% CI of B: \[-0.036, 0.065\]~Contrast between the high strain rate group and the control group: B=0.038, Std. Error of estimate of B=0.025, Beta=0.283, t=1.481, p=0.148, 95% CI of B: \[-0.014, 0.089\]"|||0.344
72573579|NCT04135196|144673725|OTHER|||||||0.676|||||||Regression, Linear|||The null hypothesis was that change in UD cBV was not proportional to strain magnitude. Raw change in cBV was analyzed as the dependent variable in a linear regression model with coefficients representing contrasts between the two experimental groups and the control group.|"Overall model fit: R\^2=0.019, F=0.395, df1=2, df2=40, p=0.676~Contrast between the low strain magnitude group and the control group: B=0.012, Std. Error of estimate of B=0.015, Beta=0.146, t=0.787, p=0.436, 95% CI of B: \[-0.019, 0.042\]~Contrast between the high strain magnitude group and the control group: B=0.001, Std. Error of estimate of B=0.014, Beta=0.013, t=0.070, p=0.945, 95% CI of B: \[-0.028, 0.029\]"|||0.676
72626834|NCT04549454|144782739|SUPERIORITY||Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.427||0.981|TWO_SIDED||||||Tukey-Kramer|||As detailed in the statistical analysis plan, a multi-level model which held constant participant age, race, ethnicity, in examining Time\*Arm interactions on peak drinks. To probe the significant Time\*Arm interaction, a Tukey post-hoc test examined the change in peak drinks from baseline to the 6-month follow-up in the Intervention Arm versus the Control Arm.||||.981
72626835|NCT04549454|144782740|SUPERIORITY||Median Difference (Final Values)|-0.045|STANDARD_ERROR_OF_MEAN|0.327||0.889|TWO_SIDED||||||Tukey-Kramer|||As detailed in the statistical analysis plan, a multi-level model which held constant participant age, race, ethnicity, in examining Time\*Arm interactions on HED. To probe the significant Time\*Arm interaction, a Tukey post-hoc test examined the change in HED from baseline to the 1-month follow-up in the Intervention Arm versus the Control Arm.||||.889
72409163|NCT04154631|144326816|SUPERIORITY||Time by treatment interaction coeff.|-9.52|||<|0.001|TWO_SIDED||||||Intent-to-treat, multilevel modeling|||Treatment condition (Standard/Adapted TranS-C versus UC-DT) on change in sleep-related impairment from pre to post.||||<0.001
72409164|NCT04154631|144326816|SUPERIORITY||Coefficient of indirect effect|0.26||||0.92|TWO_SIDED|95.0|-5.04|5.56|||SEM|||Structural equation modeling (SEM) was used to test whether the relationship between treatment condition (Standard vs. Adapted) and sleep-related impairment (PROMIS-SRI) at post was mediated by provider ratings of acceptability (AIM) at post. The parameter of interest was the indirect effect.||5.56|-5.04|0.92
72409165|NCT04154631|144326816|SUPERIORITY||Coefficient of indirect effect|0.1||||0.92|TWO_SIDED|95.0|-2.04|2.24|||SEM|||Structural equation modeling (SEM) was used to test whether the relationship between treatment condition (Standard vs. Adapted) and sleep-related impairment (PROMIS-SRI) at 6-month follow-up was mediated by provider ratings of acceptability (AIM) at post. The parameter of interest was the indirect effect.||2.24|-2.04|0.92
72409166|NCT04154631|144326816|SUPERIORITY||Coefficient of indirect effect|-0.39||||0.78|TWO_SIDED|95.0|-3.1|2.31|||SEM|||Structural equation modeling (SEM) was used to test whether the relationship between treatment condition (Standard vs. Adapted) and sleep-related impairment (PROMIS-SRI) at post was mediated by provider ratings of appropriateness (IAM) at post. The parameter of interest was the indirect effect.||2.31|-3.10|0.78
72409167|NCT04154631|144326816|SUPERIORITY||Coefficient of indirect effect|-0.3||||0.78|TWO_SIDED|95.0|-2.35|1.75|||SEM|||Structural equation modeling (SEM) was used to test whether the relationship between treatment condition (Standard vs. Adapted) and sleep-related impairment (PROMIS-SRI) at 6-month follow-up was mediated by provider ratings of appropriateness (IAM) at post. The parameter of interest was the indirect effect.||1.75|-2.35|0.78
72537231|NCT04035694|144605174|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|1.23|STANDARD_ERROR_OF_MEAN|2.68||0.65|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.65
72537232|NCT04035694|144605175|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|0.65|STANDARD_ERROR_OF_MEAN|0.15|<|0.01|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||<.01
72537233|NCT04035694|144605176|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|0.28|STANDARD_ERROR_OF_MEAN|0.22||0.2|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.20
72537234|NCT04035694|144605177|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|2.79|STANDARD_ERROR_OF_MEAN|2.22||0.28|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.28
72537235|NCT04035694|144605178|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Median Difference (Net)|1.56|STANDARD_ERROR_OF_MEAN|2.77||0.58|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.58
72573580|NCT04135196|144673725|OTHER|||||||0.289|||||||Regression, Linear|||The null hypothesis was that change in UD cBV was not proportional to strain rate. Raw change in cBV was analyzed as the dependent variable in a linear regression model with coefficients representing contrasts between the two experimental groups and the control group.|Overall model fit: R\^2=0.072, F=1.288, df1=2, df2=33, p=0.289 Contrast between the low strain rate group and the control group: B=0.014, Std. Error of estimate of B=0.018, Beta=0.154, t=0.814, p=0.422, 95% CI of B: \[-0.022, 0.051\] Contrast between the high strain rate group and the control group: B=0.029, Std. Error of estimate of B=0.018, Beta=0.304, t=1.604, p=0.118, 95% CI of B: \[-0.008, 0.066\]|||0.289
72409168|NCT04154631|144326816|SUPERIORITY||Coefficient of indirect effect|-0.43||||0.84|TWO_SIDED|95.0|-4.66|3.8|||SEM|||Structural equation modeling (SEM) was used to test whether the relationship between treatment condition (Standard vs. Adapted) and sleep-related impairment (PROMIS-SRI) at post was mediated by provider ratings of feasibility (FIM) at post. The parameter of interest was the indirect effect.||3.80|-4.66|0.84
72409169|NCT04154631|144326816|SUPERIORITY||Coefficient of indirect effect|-0.18||||0.84|TWO_SIDED|95.0|-1.94|1.58|||SEM|||Structural equation modeling (SEM) was used to test whether the relationship between treatment condition (Standard vs. Adapted) and sleep-related impairment (PROMIS-SRI) at 6-month follow-up was mediated by provider ratings of feasibility (FIM) at post. The parameter of interest was the indirect effect.||1.58|-1.94|0.84
72409170|NCT04154631|144326817|SUPERIORITY||Time by treatment interaction coeff.|1.63|||<|0.001|TWO_SIDED||||||Intent-to-treat, multilevel modeling|||Treatment condition (Standard/Adapted TranS-C versus UC-DT) on change in Composite Sleep Health Score from pre to post.||||<0.001
72409171|NCT04154631|144326818|SUPERIORITY||Time by treatment interaction coeff.|-5.12|||<|0.001|TWO_SIDED||||||Intent-to-treat, multilevel modeling|||Treatment condition (Standard/Adapted TranS-C versus UC-DT) on change in functional impairment from pre to post.||||<0.001
72409172|NCT04154631|144326818|SUPERIORITY||Coefficient of indirect effect|-3.12|||<|0.001|TWO_SIDED|95.0|-4.58|-1.66|||SEM|||Structural equation modeling (SEM) was used to test whether the relationship between TranS-C condition (Immediate vs. UC-DT) and functional impairment (Sheehan Disability Scale) at post was mediated by sleep disturbance (PROMIS-SD) at post. The parameter of interest was the indirect effect.||-1.66|-4.58|<0.001
72537236|NCT04035694|144605179|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|0.07|STANDARD_ERROR_OF_MEAN|0.1||0.49|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.49
72537237|NCT04035694|144605180|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|-0.09|STANDARD_ERROR_OF_MEAN|0.14||0.55|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||.55
72537238|NCT04035694|144605181|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|0.06|STANDARD_ERROR_OF_MEAN|0.09||0.54|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.54
72537239|NCT04035694|144605182|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|-0.01|STANDARD_ERROR_OF_MEAN|0.1||0.95|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.95
72537240|NCT04035694|144605183|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Median Difference (Net)|-4.25|STANDARD_ERROR_OF_MEAN|2.15||0.05|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.05
72537241|NCT04035694|144605184|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|1.37|STANDARD_ERROR_OF_MEAN|3.84||0.75|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.75
72576784|NCT00261443|144680651|SUPERIORITY_OR_OTHER_LEGACY||Difference|-2.33|||<|0.001|TWO_SIDED|95.0|-3.7|-0.95||Mean change from baseline: ANOVA model, controlling for treatment, mood stabilizer, index mood episode, and baseline value. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 32 Comparison||-0.95|-3.70|<0.001
72537242|NCT04035694|144605185|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|0.14|STANDARD_ERROR_OF_MEAN|0.09||0.14|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.14
72537243|NCT04035694|144605186|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|0.18|STANDARD_ERROR_OF_MEAN|0.08||0.03|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.03
72537244|NCT04035694|144605187|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|0.18|STANDARD_ERROR_OF_MEAN|0.06||0.01|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.01
72537245|NCT04035694|144605188|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|0.2|STANDARD_ERROR_OF_MEAN|0.08||0.02|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.02
72409173|NCT04154631|144326818|SUPERIORITY||Coefficient of indirect effect|-3.81|||<|0.001|TWO_SIDED|95.0|-5.41|-2.22|||SEM|||Structural equation modeling (SEM) was used to test whether the relationship between TranS-C condition (Immediate vs. UC-DT) and functional impairment (Sheehan Disability Scale) at post was mediated by sleep-related impairment (PROMIS-SRI). The parameter of interest was the indirect effect at post||-2.22|-5.41|<0.001
72537246|NCT04035694|144605189|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|0.14|STANDARD_ERROR_OF_MEAN|0.06||0.03|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.03
72537247|NCT04035694|144605190|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|-0.08|STANDARD_ERROR_OF_MEAN|0.13||0.57|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.57
72573581|NCT04135196|144673726|OTHER|||||||0.096|||||||Regression, Linear|||The null hypothesis was that change in UD ecBV was not proportional to strain magnitude. Raw change in ecBV was analyzed as the dependent variable in a linear regression model with coefficients representing contrasts between the two experimental groups and the control group.|"Overall model fit: R\^2=0.111, F=2.491, df1=2, df2=40, p=0.096~Contrast between the low strain magnitude group and the control group: B=0.026, Std. Error of estimate of B=0.012, Beta=0.391, t=2.222, p=0.032, 95% CI of B: \[0.032, 0.049\]~Contrast between the high strain magnitude group and the control group: B=0.015, Std. Error of estimate of B=0.011, Beta=0.240, t=1.362, p=0.181, 95% CI of B: \[-0.007, 0.037\]"|||0.096
72573582|NCT04135196|144673726|OTHER|||||||0.344|||||||Regression, Linear|||The null hypothesis was that change in UD ecBV was not proportional to strain rate. Raw change in ecBV was analyzed as the dependent variable in a linear regression model with coefficients representing contrasts between the two experimental groups and the control group.|"Overall model fit: R\^2=0.063, F=1.103, df1=2, df2=33, p=0.344~Contrast between the low strain rate group and the control group: B=0.014, Std. Error of estimate of B=0.015, Beta=0.113, t=0.595, p=0.556, 95% CI of B: \[-0.036, 0.065\]~Contrast between the high strain rate group and the control group: B=0.038, Std. Error of estimate of B=0.025, Beta=0.283, t=1.481, p=0.148, 95% CI of B: \[-0.014, 0.089\]"|||0.344
72573583|NCT04135196|144673727|OTHER|||||||0.332|||||||Regression, Linear|||The null hypothesis was that change in UD tBV was not proportional to strain magnitude. Raw change in tBV was analyzed as the dependent variable in a linear regression model with coefficients representing contrasts between the two experimental groups and the control group.|"Overall model fit: R\^2=0.054, F=1.132, df1=2, df2=40, p=0.332~Contrast between the low strain magnitude group and the control group: B=0.016, Std. Error of estimate of B=0.011, Beta=0.271, t=1.493, p=0.143, 95% CI of B: \[-0.006, 0.039\]~Contrast between the high strain magnitude group and the control group: B=0.007, Std. Error of estimate of B=0.010, Beta=0.115, t=635, p=0.529, 95% CI of B: \[-0.014, 0.028\]"|||0.332
72573584|NCT04135196|144673727|OTHER|||||||0.399|||||||Regression, Linear|||The null hypothesis was that change in UD tBV was not proportional to strain rate. Raw change in tBV was analyzed as the dependent variable in a linear regression model with coefficients representing contrasts between the two experimental groups and the control group.|"Overall model fit: R\^2=0.054, F=0.946, df1=2, df2=33, p=0.399~Contrast between the low strain rate group and the control group: B=0.008, Std. Error of estimate of B=0.012, Beta=0.119, t=0.619, p=0.540, 95% CI of B: \[-0.017, 0.032\]~Contrast between the high strain rate group and the control group: B=0.017, Std. Error of estimate of B=0.012, Beta=0.264, t=1.375, p=0.178, 95% CI of B: \[-0.008, 0.042\]"|||0.399
72573585|NCT04135196|144673728|OTHER|||||||||||||||||The null hypothesis was that change in cortical thickness was not proportional to strain magnitude. At each time point, raw change relative to baseline was analyzed as the dependent variable in a linear regression model with coefficients representing contrasts between the two experimental groups and the control group.|"At each time point, the overall fit of the linear regression model was assessed with an F-test of overall significance. Additionally, the significance of each coefficient representing contrasts between each experimental group and the control group was assessed using t-tests.~There were no significant relationships found between change in cortical thickness and strain magnitude group at any time point (p\>0.05)."|||
72576785|NCT00261443|144680651|SUPERIORITY_OR_OTHER_LEGACY||Difference|-2.78|||<|0.001|TWO_SIDED|95.0|-4.19|-1.37||Mean change from baseline: ANOVA model, controlling for treatment, mood stabilizer, index mood episode, and baseline value. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 36 Comparison||-1.37|-4.19|<0.001
72626836|NCT04549454|144782741|SUPERIORITY||Mean Difference (Final Values)|-0.186|STANDARD_ERROR_OF_MEAN|0.338||0.582|TWO_SIDED||||||Tukey-Kramer|||As detailed in the statistical analysis plan, a multi-level model which held constant participant age, race, ethnicity, in examining Time\*Arm interactions on HED. To probe the significant Time\*Arm interaction, a Tukey post-hoc test examined the change in HED from baseline to the 6-month follow-up in the Intervention Arm versus the Control Arm.||||.582
72537248|NCT04035694|144605191|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|0.01|STANDARD_ERROR_OF_MEAN|0.08||0.91|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.91
72626837|NCT03110562|144782746|SUPERIORITY||Hazard Ratio (HR)|0.702||||0.0075|TWO_SIDED|95.0|0.5279|0.9335||One Sided P-value|Stratified Log-rank Test|Stratified for prior PI therapies, number of prior of anti-MM regimens and R-ISS Stage at screening.|Based on stratified Cox Proportional Hazard model with Efron's Method of handling ties.|||0.9335|0.5279|0.0075
72626838|NCT03110562|144782747|SUPERIORITY||Odds Ratio (OR)|1.9626||||0.0012|TWO_SIDED|95.0|1.2641|3.0471||One Sided P-value|Cochran-Mantel-Haenszel|Analysis using Cochran-Mantel-Haenszel test stratified by region, prior PI therapies, number of prior anti-MM regimens, and R-ISS stage at screening.||||3.0471|1.2641|0.0012
72626839|NCT03110562|144782748|SUPERIORITY||Odds Ratio (OR)|1.6594||||0.0082|TWO_SIDED|95.0|1.0993|2.5049||One Sided P-value|Cochran-Mantel-Haenszel|Analysis using Cochran-Mantel-Haenszel test stratified by region, prior PI therapies, number of prior anti-MM regimens, and R-ISS stage at screening.||||2.5049|1.0993|0.0082
72626840|NCT03110562|144782749|SUPERIORITY||Odds Ratio (OR)|0.5042||||0.0013|TWO_SIDED|95.0|0.3216|0.7906||One Sided P-value|Cochran-Mantel-Haenszel||Stratified by Prior PI therapies (Yes or No), Number of prior anti-MM regimens (1 or \>1), and R-ISS stage at study entry (R-ISS Stage III versus R-ISS Stage I or II).|||0.7906|0.3216|0.0013
72626841|NCT03110562|144782750|SUPERIORITY||Hazard Ratio (HR)|0.8764||||0.2152|TWO_SIDED|95.0|0.6313|1.2168||One Sided P-value|Stratified log-rank test|Stratified for prior PI therapies, number of prior anti-MM regimens and R-ISS Stage at screening.|Based on stratified Cox Proportional Hazard model with Efron's Method of handling ties.|||1.2168|0.6313|0.2152
72626842|NCT05788991|144782782|NON_INFERIORITY|Difference of proportions between groups (with 95% CI) and a non inferiority margin of 15 percentage points, assuming a 1-sided α = .025 and 80% power|Farrington-Manning test|-0.5|||<|0.025|ONE_SIDED|95.0|-10.8|||1 sided alpha|Farrington-Manning test|||The outcome measure of the primary objective was a noninferiority margin of 15 percentage points in the absolute difference in clinical cure rates between dequalinium chloride and metronidazole 7 to 11 days after start of treatment.|||-10.8|<.025
72369071|NCT00531661|144248129|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||exact test of binomial proportions|P-value from exact test of binomial proportions compared proportion of all implanted patients free from pressure sensor failure to OPC of 0.90.||"Analysis of sensor failures was based on the following pre-specified objective performance criteria: the lower limit of the two-sided 95.2% confidence interval on the freedom from pressure sensor failure rate for all implanted patients was at least 90%. The statistical hypotheses were:~Null: (Freedom from device / system-related complications) ≤ 90%~Alternative: (Freedom from device / system-related complications) \> 90%"||||<0.0001
72537249|NCT04035694|144605192|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|0.04|STANDARD_ERROR_OF_MEAN|0.11||0.72|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.72
72537250|NCT04035694|144605193|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|0.2|STANDARD_ERROR_OF_MEAN|0.09||0.07|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.07
72537251|NCT04035694|144605194|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|-0.06|STANDARD_ERROR_OF_MEAN|0.1||0.56|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.56
72626843|NCT05270863|144782789|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|||||||<.001
72626844|NCT04464473|144782790|SUPERIORITY|||||||0.5736|||||||ANOVA|The main effect of visit (Baseline, FPl-TMS, MFG-TMS, S1-TMS) on the overall magnitude of MFG efferent connectivity||||||0.5736
72626845|NCT04464473|144782790|SUPERIORITY|||||||0.304|||||||ANOVA|Interaction of visit (Baseline, FPl-TMS, MFG-TMS, S1-TMS) and subsystem (Temporal, Contextual Control) on the magnitude of MFG efferent connectivity||||||0.304
72626846|NCT04464473|144782790|SUPERIORITY|||||||0.0545|||||||ANOVA|The main effect of visit (Baseline, FPl-TMS, MFG-TMS, S1-TMS) on the overall magnitude of FPl efferent connectivity||||||0.0545
72626847|NCT04464473|144782790|SUPERIORITY|||||||0.1134|||||||ANOVA|Interaction of visit (Baseline, FPl-TMS, MFG-TMS, S1-TMS) and Subsystem on the magnitude of FPl efferent connectivity||||||0.1134
72626848|NCT04464473|144782790|SUPERIORITY|||||||0.4326|||||||ANOVA|The main effect of intervention (FPl-TMS, MFG-TMS, S1-TMS) on the overall magnitude of MFG efferent connectivity||||||0.4326
72626849|NCT04464473|144782790|SUPERIORITY|||||||0.2546|||||||ANOVA|The interaction of intervention (FPl-TMS, MFG-TMS, S1-TMS) and subsystem (Temporal, Contextual Control) on the magnitude of MFG efferent connectivity||||||0.2546
72369072|NCT02858362|144248136|OTHER|Difference in least square means. All 23 participants in the population were included in the statistical analysis.|Mean Difference (Final Values)|0.023|||||TWO_SIDED|95.0|-0.002|0.048||||||Week 24 Change from Baseline||0.048|-0.002|
72626850|NCT04464473|144782790|SUPERIORITY|||||||0.0645|||||||ANOVA|The main effect of intervention (FPl-TMS, MFG-TMS, S1-TMS) on the overall magnitude of FPl efferent connectivity||||||0.0645
72626851|NCT04464473|144782790|SUPERIORITY|||||||0.2033|||||||ANOVA|Interaction of intervention (FPl-TMS, MFG-TMS, S1-TMS) and Subsystem on the magnitude of FPl efferent connectivity||||||0.2033
72626852|NCT04464473|144782791|SUPERIORITY|||||||0.8152|||||||ANOVA|Main effect of visit (Baseline, MFG-cTBS, FPl-cTBS, S1-cTBS) on overall BOLD actviation.||||||0.8152
72369073|NCT02858362|144248136|OTHER|Difference in least square means. All 16 participants in the population were included in the statistical analysis.|Mean Difference (Final Values)|0.006|||||TWO_SIDED|95.0|-0.03|0.042||||||Week 48 Change from Baseline||0.042|-0.03|
72537252|NCT04035694|144605195|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|0.16|STANDARD_ERROR_OF_MEAN|0.11||0.17|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.17
72537253|NCT04035694|144605196|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|-0.02|STANDARD_ERROR_OF_MEAN|0.12||0.89|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.89
72573586|NCT04135196|144673728|OTHER|||||||||||||||||The null hypothesis was that change in cortical thickness was not proportional to strain rate. At each time point, raw change relative to baseline was analyzed as the dependent variable in a linear regression model with coefficients representing contrasts between the two experimental groups and the control group.|"At each time point, the overall fit of the linear regression model was assessed with an F-test of overall significance. Additionally, the significance of each coefficient representing contrasts between each experimental group and the control group was assessed using t-tests.~At 3 months, there was a significant overall linear relationship between change in cortical thickness and strain rate group. Additionally, the coefficient representing the contrast between the control group and the high strain rate group was also significant. All other comparisons were not statistically significant (p\>0.05).~Stats for 3 months:~Overall model fit: R\^2=0.258, F=4.519, df1=2, df2=26, p=0.021~Contrast between the high strain rate group and the control group: B=0.036, Std. Error of estimate of B=0.012, Beta=0.574, t=2.967, p=0.006, 95% CI of B: \[0.011, 0.061\]"|||
72573587|NCT04135196|144673729|OTHER|||||||||||||||||The null hypothesis was that change in bone volume fraction (BV/TV) was not proportional to strain magnitude. At each time point, raw change relative to baseline was analyzed as the dependent variable in a linear regression model with coefficients representing contrasts between the two experimental groups and the control group.|"At each time point, the overall fit of the linear regression model was assessed with an F-test of overall significance. Additionally, the significance of each coefficient representing contrasts between each experimental group and the control group was assessed using t-tests.~At 9 months, there was a significant overall linear relationship between change in BV/TV and strain magnitude group. Additionally, the coefficient representing the contrast between the control group and the low strain magnitude group was also significant. All other comparisons were not statistically significant (p\>0.05).~Stats for 9 months:~Overall model fit: R\^2=0.240, F=5.057, df1=2, df2=32, p=0.012~Contrast between the low strain magnitude group and the control group: B=0.003, Std. Error of estimate of B=0.001, Beta=0.562, t=3.180, p=0.003, 95% CI of B: \[0.001, 0.006\]"|||
72573588|NCT04135196|144673729|OTHER||||||>|0.05|||||||Regression, Linear|||The null hypothesis was that change in bone volume fraction (BV/TV) was not proportional to strain rate. At each time point, raw change relative to baseline was analyzed as the dependent variable in a linear regression model with coefficients representing contrasts between the two experimental groups and the control group.|At each time point, the overall fit of the linear regression model was assessed with an F-test of overall significance. Additionally, the significance of each coefficient representing contrasts between each experimental group and the control group was assessed using t-tests.|||>0.05
72573589|NCT00911807|144673730|SUPERIORITY_OR_OTHER||Mean Square (Factor Treatment)|19.59||||0.6348||||||ANCOVA F-test. The study was designed to show significant differences in each of the two primary variables. No adjustment for multiple testing was needed and all tests were done with retention of the full two-sided alpha-level of 0.05.|ANCOVA|ANCOVA with the week 28 ADAS-cog+ change score as dependent variable and the ADAS-cog+ baseline score as a covariate.||The null-hypothesis stated no differences between the three treatment groups regarding the mean change from baseline in ADAS-cog+ at week 28. A sample size of approximately 60 evaluable patients per treatment arm was estimated to allow for the detection of a significant group difference of two points in ADAS-cog+ week 28 change score (standard deviation \[SD\] 3.3) between the three groups with a power of \> 80% and a probability level of alpha = 0.05 (two-sided).||||0.6348
72626853|NCT04464473|144782791|SUPERIORITY|||||||0.0085|||||||ANOVA|Interaction of visit (Baseline, MFG-cTBS, FPl-cTBS, S1-cTBS) and subsystem (temporal, contextual, sensorimotor control) on overall BOLD activation.||||||0.0085
72626854|NCT04464473|144782791|SUPERIORITY|||||||0.1551|||||||ANOVA|Interaction of visit (Baseline, MFG-cTBS, FPl-cTBS, S1-cTBS) and temporal control on BOLD activation||||||0.1551
72537254|NCT04035694|144605197|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|0.11|STANDARD_ERROR_OF_MEAN|0.08||0.2|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||.20
72573590|NCT00911807|144673730|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.63||||0.583||95.0|-2.891|1.63||No adjustment for multiple testing was needed and all tests were done with retention of the full two-sided alpha-level of 0.05.|t-test, 2 sided|Comparisons between all pair of means were performed with two-sample t-tests within the ANCOVA model.||Multiple testing of individual null hypotheses that control for the overall significance level alpha = 0.05 were performed by using the 'closed testing procedure'||1.630|-2.891|0.5830
72626855|NCT04464473|144782791|SUPERIORITY|||||||0.6431|||||||ANOVA|Interaction of visit (Baseline, MFG-cTBS, FPl-cTBS, S1-cTBS) and contextual control on BOLD activation||||||0.6431
72626856|NCT04464473|144782791|SUPERIORITY|||||||0.2447|||||||ANOVA|Interaction of visit (Baseline, MFG-cTBS, FPl-cTBS, S1-cTBS), temporal control, and contextual control on BOLD activation||||||0.2447
72537255|NCT04035694|144605198|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|-0.05|STANDARD_ERROR_OF_MEAN|0.16||0.78|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.78
72537256|NCT04035694|144605199|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|-0.08|STANDARD_ERROR_OF_MEAN|0.09||0.41|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.41
72537257|NCT04035694|144605200|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|-0.13|STANDARD_ERROR_OF_MEAN|0.11||0.34|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.34
72537258|NCT01856257|144605201|SUPERIORITY||Mean Difference (Final Values)|3.512||||0.544|TWO_SIDED|95.0|-7.999|15.024|||Mixed Models Analysis||The p-value, estimate of the treatment group difference, and estimated 95% confidence interval result from a repeated measures mixed model using available eGFR data from weeks 4, 12, 28, 36, and 52 to compare Group 2 to Group 1.|||15.024|-7.999|0.544
72537259|NCT01856257|144605201|SUPERIORITY||Mean Difference (Final Values)|4.82||||0.531|TWO_SIDED|95.0|-10.481|20.121|||Mixed Models Analysis||P-value estimate of the treatment group difference, and estimated 95% confidence interval result from a repeated measures mixed model using available eGFR data from weeks 4, 12, 28, 36, and 52 to compare Group 3 to Group 1.|||20.121|-10.481|0.531
72537260|NCT00442338|144605232|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|0.01||||0.871|TWO_SIDED|95.0|-0.07|0.08|||ANCOVA|The model included a factor for treatment and used the baseline FEV1 as a covariate.||Treatment difference in change from Baseline in FEV1 within the first 60 minutes after study drug administration was assessed as the difference in the least square (LS) means of time weighted average change FEV1 (0-60 min) using an Analysis of Covariance (ANCOVA) model.||0.08|-0.07|0.871
72537261|NCT00442338|144605232|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.01||||0.794|TWO_SIDED|95.0|-0.08|0.06|||ANCOVA|The model included a factor for treatment and used the baseline FEV1 as a covariate.||Treatment difference in change from Baseline in FEV1 within the first 60 minutes after study drug administration was assessed as the difference in the LS means of time weighted average change FEV1 (0-60 min) using an ANCOVA model.||0.06|-0.08|0.794
72537262|NCT00442338|144605232|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|0.02||||0.675|TWO_SIDED|95.0|-0.06|0.09|||ANCOVA|The model included a factor for treatment and used the baseline FEV1 as a covariate.||Treatment difference in change from Baseline in FEV1 within the first 60 minutes after study drug administration was assessed as the difference in the LS means of time weighted average change FEV1 (0-60 min) using an ANCOVA model.||0.09|-0.06|0.675
72537263|NCT01125358|144605233|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|-2.02|||||TWO_SIDED|90.0|-3.37|0.0|||Multiple Comparisons with The Best (MCB)|LS mean difference = LS mean of 10 mg LY2140023 - LS mean of 80 mg LY2140023.||||0.00|-3.37|
72537264|NCT01125358|144605233|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|-1.05|||||TWO_SIDED|90.0|-2.42|0.32|||Multiple Comparison with The Best (MCB)|LS mean difference = LS mean of 160 mg LY2140023 - LS mean of 80 mg LY2140023.||||0.32|-2.42|
72537265|NCT01125358|144605234|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|-9.84|STANDARD_ERROR_OF_MEAN|7.96||0.222|TWO_SIDED|95.0|-25.8|6.12||P-value is for PANSS Total Score.|MMRM|||||6.12|-25.80|0.222
72537266|NCT01125358|144605234|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|-11.91|STANDARD_ERROR_OF_MEAN|7.22||0.105|TWO_SIDED|95.0|-26.42|2.6||P-value is for PANSS Total Score.|MMRM|||||2.60|-26.42|0.105
72537267|NCT01125358|144605234|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|-7.96|STANDARD_ERROR_OF_MEAN|7.73||0.308|TWO_SIDED|95.0|-23.46|7.55||P-value is for PANSS Total Score.|MMRM|||||7.55|-23.46|0.308
72537268|NCT01125358|144605234|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|-1.6|STANDARD_ERROR_OF_MEAN|2.06||0.441|TWO_SIDED|95.0|-5.74|2.54||P-value is for PANSS Positive Subscore.|MMRM|||||2.54|-5.74|0.441
72537269|NCT01125358|144605234|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|-4.22|STANDARD_ERROR_OF_MEAN|1.88||0.03||95.0|-8.01|-0.44||P-value is for PANSS Positive Subscore.|MMRM|||||-0.44|-8.01|0.030
72537270|NCT01125358|144605234|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|-1.98|STANDARD_ERROR_OF_MEAN|1.98||0.323|TWO_SIDED|95.0|-5.96|2.01||P-value is for PANSS Positive Subscore.|MMRM|||||2.01|-5.96|0.323
72537271|NCT01125358|144605234|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|-2.46|STANDARD_ERROR_OF_MEAN|2.28||0.285|TWO_SIDED|95.0|-7.05|2.12||P-value is for PANSS Negative Subscore.|MMRM|||||2.12|-7.05|0.285
72537272|NCT01125358|144605234|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|-2.92|STANDARD_ERROR_OF_MEAN|2.07||0.166|TWO_SIDED|95.0|-7.1|1.26||P-value is for PANSS Negative Subscore.|MMRM|||||1.26|-7.10|0.166
72537273|NCT01125358|144605234|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|-2.37|STANDARD_ERROR_OF_MEAN|2.2||0.286|TWO_SIDED|95.0|-6.79|2.05||P-value is for PANSS Negative Subscore.|MMRM|||||2.05|-6.79|0.286
72537274|NCT01125358|144605234|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|-5.67|STANDARD_ERROR_OF_MEAN|4.14||0.177|TWO_SIDED|95.0|-13.96|2.63||P-value is for PANSS General Psychopathology Subscore.|MMRM|||||2.63|-13.96|0.177
72537275|NCT01125358|144605234|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|-5.1|STANDARD_ERROR_OF_MEAN|3.74||0.178|TWO_SIDED|95.0|-12.6|2.4||P-value is for PANSS General Psychopathology Subscore.|MMRM|||||2.40|-12.60|0.178
72537276|NCT01125358|144605234|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|-3.61|STANDARD_ERROR_OF_MEAN|4.05||0.377|TWO_SIDED|95.0|-11.72|4.51||P-value is for PANSS General Psychopathology Subscore.|MMRM|||||4.51|-11.72|0.377
72537277|NCT01125358|144605235|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|0.87|STANDARD_ERROR_OF_MEAN|0.48||0.077|TWO_SIDED|95.0|-0.1|1.83|||MMRM|||||1.83|-0.10|0.077
72537278|NCT01125358|144605235|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|-0.24|STANDARD_ERROR_OF_MEAN|0.44||0.592|TWO_SIDED|95.0|-1.12|0.65|||MMRM|||||0.65|-1.12|0.592
72537279|NCT01125358|144605235|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|0.39|STANDARD_ERROR_OF_MEAN|0.46||0.395|TWO_SIDED|95.0|-0.53|1.32|||MMRM|||||1.32|-0.53|0.395
72537280|NCT01125358|144605236|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|4.64|STANDARD_ERROR_OF_MEAN|4.49||0.306|TWO_SIDED|95.0|-4.37|13.65|||MMRM|||||13.65|-4.37|0.306
72537281|NCT01125358|144605236|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|0.82|STANDARD_ERROR_OF_MEAN|4.26||0.849|TWO_SIDED|95.0|-7.74|9.38|||MMRM|||||9.38|-7.74|0.849
72537282|NCT01125358|144605236|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|-5.09|STANDARD_ERROR_OF_MEAN|4.46||0.259||95.0|-14.05|3.86|||MMRM|||||3.86|-14.05|0.259
72537283|NCT01125358|144605238|SUPERIORITY_OR_OTHER_LEGACY|||||||0.354||95.0|||||Fisher Exact|||||||0.354
72537284|NCT01125358|144605238|SUPERIORITY_OR_OTHER_LEGACY|||||||0.181||95.0|||||Fisher Exact|||||||0.181
72537285|NCT01125358|144605238|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.999||95.0|||||Fisher Exact|||||||>0.999
72537286|NCT00318409|144605246|SUPERIORITY_OR_OTHER|||||||0.98||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.98
72537287|NCT00742859|144605261|OTHER||Hazard Ratio (HR)|0.14||||0.035|TWO_SIDED|95.0|0.017|1.14|||Log Rank|||Betrixaban 40mg compared to Warfarin||1.14|0.017|0.035
72537288|NCT00742859|144605261|OTHER||Hazard Ratio (HR)|0.711||||0.546|TWO_SIDED|95.0|0.225|2.24|||Log Rank|||Betrixaban 60mg compared to Warfarin||2.24|0.225|0.546
72537289|NCT00742859|144605261|OTHER||Hazard Ratio (HR)|0.755||||0.712|TWO_SIDED|95.0|0.239|2.39|||Log Rank|||Betrixaban 80mg compared to Warfarin||2.39|0.239|0.712
72537290|NCT00742859|144605262|OTHER||Hazard Ratio (HR)|0.508||||0.011|TWO_SIDED|95.0|0.301|0.856|||Log Rank|||Betrixaban 40mg compared to Warfarin||0.856|0.301|0.011
72537291|NCT00742859|144605262|OTHER||Hazard Ratio (HR)|0.767||||0.308|TWO_SIDED|95.0|0.481|1.22|||Log Rank|||Betrixaban 60mg compared to Warfarin||1.22|0.481|0.308
72537292|NCT00742859|144605262|OTHER||Hazard Ratio (HR)|0.551||||0.022|TWO_SIDED|95.0|0.332|0.914|||Log Rank|||Betrixaban 80mg compared to Warfarin||0.914|0.332|0.022
72537293|NCT00956709|144605263|SUPERIORITY_OR_OTHER|||||||0.56||||||Two patients in each group had incomplete block before sugery.|Wilcoxon (Mann-Whitney)|||||||0.56
72537294|NCT00956709|144605265|SUPERIORITY_OR_OTHER|||||||0.3354|||||||Wilcoxon (Mann-Whitney)|||||||0.3354
72537295|NCT00956709|144605266|SUPERIORITY_OR_OTHER|||||||0.0445|||||||Wilcoxon (Mann-Whitney)|||||||0.0445
72537296|NCT00962013|144605267|NON_INFERIORITY_OR_EQUIVALENCE|non-inferiority margin is 7%||||||0.0136|||||||Exact Binomial|||This revision study will demonstrate a 5-year survivorship of the Restoration Modular system not seven percent worse than an expected 95% survival rate using a lower 95% one-sided confidence bound.||||0.0136
72537297|NCT00962013|144605269|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||Change from HHS pre-op to HHS 5 year||||<0.0001
72537298|NCT00962013|144605270|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||Change from SF-36 Role-Physical pre-op score to 2 and 5 year scores||||<0.0001
72537299|NCT00962013|144605272|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Exact Binomial|||Post-surgery femoral stem crack/fracture rate compared to 21% (pre-specified in protocol based on literature rates) Femoral subsidence rate compared to 18% (pre-specified in protocol based on literature rates)||||<0.0001
72537300|NCT03706209|144605288|SUPERIORITY||Odds Ratio (OR)|4.12||||0.161|TWO_SIDED|95.0|0.47|35.97|||Cochran-Mantel-Haenszel|||||35.97|0.47|0.161
72537301|NCT03706209|144605288|SUPERIORITY||Odds Ratio (OR)|5.52||||0.111|TWO_SIDED|95.0|0.55|55.43|||Cochran-Mantel-Haenszel|||||55.43|0.55|0.111
72537302|NCT03706209|144605289|SUPERIORITY||Odds Ratio (OR)|1.73||||0.222|TWO_SIDED|95.0|0.71|4.25|||Cochran-Mantel-Haenszel|||||4.25|0.71|0.222
72537303|NCT03706209|144605289|SUPERIORITY||Odds Ratio (OR)|1.91||||0.182|TWO_SIDED|95.0|0.75|4.91|||Cochran-Mantel-Haenszel|||||4.91|0.75|0.182
72537304|NCT03706209|144605290|SUPERIORITY||Odds Ratio (OR)|2.91||||0.294|TWO_SIDED|95.0|0.33|25.39|||Cochran-Mantel-Haenszel|||||25.39|0.33|0.294
72537305|NCT03706209|144605290|SUPERIORITY||Odds Ratio (OR)|4.06||||0.291|TWO_SIDED|95.0|0.31|53.14|||Cochran-Mantel-Haenszel|||||53.14|0.31|0.291
72537306|NCT03706209|144605291|SUPERIORITY||Odds Ratio (OR)|1.31||||0.617|TWO_SIDED|95.0|0.45|3.77|||Cochran-Mantel-Haenszel|||||3.77|0.45|0.617
72537307|NCT03706209|144605291|SUPERIORITY||Odds Ratio (OR)|1.73||||0.319|TWO_SIDED|95.0|0.6|5.0|||Cochran-Mantel-Haenszel|||||5|0.6|0.319
72626857|NCT04464473|144782791|SUPERIORITY|||||||0.0002|||||||ANOVA|Interaction of visit (Baseline, MFG-cTBS, FPl-cTBS, S1-cTBS), temporal control, and subsystem (temporal, contextual, sensorimotor) on BOLD activation||||||0.0002
72537308|NCT03706209|144605292|SUPERIORITY||Odds Ratio (OR)|1.5||||0.47|TWO_SIDED|95.0|0.5|4.52|||Cochran-Mantel-Haenszel|||||4.52|0.5|0.47
72537309|NCT03706209|144605292|SUPERIORITY||Odds Ratio (OR)|2.44||||0.136|TWO_SIDED|95.0|0.76|7.82|||Cochran-Mantel-Haenszel|||||7.82|0.76|0.136
72537310|NCT03706209|144605293|SUPERIORITY||least square means|0.2|STANDARD_ERROR_OF_MEAN|1.4||0.894|TWO_SIDED|95.0|-2.6|3.0|||ANCOVA|||||3|-2.6|0.894
72537311|NCT03706209|144605293|SUPERIORITY||least square means|-1.1|STANDARD_ERROR_OF_MEAN|1.4||0.456|TWO_SIDED|95.0|-3.8|1.7|||ANCOVA|||Estimates and treatment comparison of least square means using an ANCOVA model, with treatment arm and (pooled) analysis center as factors and baseline outcome as covariate.||1.7|-3.8|0.456
72537312|NCT03706209|144605295|SUPERIORITY|||||||0.572|||||||Log Rank|Kaplan-Meier estimate of the median time (day) to reach the PASI 75 criterion was not computed since data were too sparse.||||||0.572
72537313|NCT03706209|144605295|SUPERIORITY|||||||0.4494|||||||Log Rank|Kaplan-Meier estimate of the median time (day) to reach the PASI 75 criterion was not computed since data were too sparse.||||||0.4494
72537314|NCT03706209|144605296|SUPERIORITY|||||||0.7922|||||||Log Rank|Kaplan-Meier estimate of the median time (day) to reach the PASI 50 criterion was not computed since data were too sparse.||||||0.7922
72537315|NCT03706209|144605296|SUPERIORITY|||||||0.1425|||||||Log Rank|Kaplan-Meier estimate of the median time (day) to reach the PASI 50 criterion was not computed since data were too sparse.||||||0.1425
72537316|NCT03706209|144605297|SUPERIORITY||Hodges-Lehmann using location shift|0.0|STANDARD_ERROR_OF_MEAN|0.0||0.992|TWO_SIDED|95.0|0.0|0.0|||Wilcoxon (Mann-Whitney)|||||0|0|0.992
72537317|NCT03706209|144605297|SUPERIORITY||Hodges-Lehmann using location shift|0.0|STANDARD_ERROR_OF_MEAN|0.0||0.143|TWO_SIDED|95.0|0.0|0.0|||Wilcoxon (Mann-Whitney)|||||0|0|0.143
72537318|NCT03706209|144605300|SUPERIORITY|||||||0.178|TWO_SIDED|95.0|||||Cochran-Mantel-Haenszel|||||||0.178
72537319|NCT03706209|144605300|SUPERIORITY||Odds Ratio (OR)|0.63||||0.718|TWO_SIDED|95.0|0.05|7.48|||Cochran-Mantel-Haenszel|||||7.48|0.05|0.718
72537320|NCT03706209|144605301|SUPERIORITY||Odds Ratio (OR)|2.4||||0.474|TWO_SIDED|95.0|0.21|28.05|||Cochran-Mantel-Haenszel|||||28.05|0.21|0.474
72537321|NCT03706209|144605301|SUPERIORITY||Odds Ratio (OR)|1.25||||0.867|TWO_SIDED|95.0|0.08|19.05|||Cochran-Mantel-Haenszel|||||19.05|0.08|0.867
72537322|NCT03706209|144605302|SUPERIORITY||Odds Ratio (OR)|2.2||||0.375|TWO_SIDED|95.0|0.38|12.84|||Cochran-Mantel-Haenszel|||||12.84|0.38|0.375
72537323|NCT03706209|144605302|SUPERIORITY||Odds Ratio (OR)|4.24||||0.116|TWO_SIDED|95.0|0.66|27.08|||Cochran-Mantel-Haenszel|||||27.08|0.66|0.116
72537324|NCT03706209|144605303|SUPERIORITY||Odds Ratio (OR)|0.41||||0.287|TWO_SIDED|95.0|0.08|2.27|||Cochran-Mantel-Haenszel|||||2.27|0.08|0.287
72537325|NCT03706209|144605303|SUPERIORITY||Odds Ratio (OR)|1.85||||0.332|TWO_SIDED|95.0|0.53|6.4|||Cochran-Mantel-Haenszel|||||6.4|0.53|0.332
72537326|NCT03706209|144605304|SUPERIORITY||Odds Ratio (OR)|0.81||||0.719|TWO_SIDED|95.0|0.25|2.63|||Cochran-Mantel-Haenszel|||||2.63|0.25|0.719
72537327|NCT03706209|144605304|SUPERIORITY||Odds Ratio (OR)|1.72||||0.357|TWO_SIDED|95.0|0.55|5.32|||Cochran-Mantel-Haenszel|||||5.32|0.55|0.357
72537328|NCT03706209|144605305|SUPERIORITY||Odds Ratio (OR)|1.75||||0.355|TWO_SIDED|95.0|0.53|5.72|||Cochran-Mantel-Haenszel|||||5.72|0.53|0.355
72537329|NCT03706209|144605305|SUPERIORITY||Odds Ratio (OR)|2.22||||0.198|TWO_SIDED|95.0|0.67|7.37|||Cochran-Mantel-Haenszel|||||7.37|0.67|0.198
72537330|NCT03706209|144605306|SUPERIORITY||least square means|0.3|STANDARD_ERROR_OF_MEAN|1.0||0.757|TWO_SIDED|95.0|-1.7|2.3|||ANCOVA|||Estimates and treatment comparison of least square means using an ANCOVA model, with treatment arm and (pooled) analysis center as factors and baseline outcome as covariate.||2.3|-1.7|0.757
72573591|NCT00911807|144673730|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.08||||0.3434||95.0|-3.324|1.163||No adjustment for multiple testing was needed and all tests were done with retention of the full two-sided alpha-level of 0.05.|t-test, 2 sided|Comparisons between all pair of means were performed with two-sample t-tests within the ANCOVA model.||Multiple testing of individual null hypotheses that control for the overall significance level alpha = 0.05 were performed by using the 'closed testing procedure'.||1.163|-3.324|0.3434
72409174|NCT04154631|144326818|SUPERIORITY||Coefficient of indirect effect|0.07||||0.94|TWO_SIDED|95.0|-1.78|1.92|||SEM|||Structural equation modeling (SEM) was used to test whether the relationship between treatment condition (Standard vs. Adapted) and functional impairment (Sheehan Disability Scale) at post was mediated by provider ratings of acceptability (AIM) at post. The parameter of interest was the indirect effect.||1.92|-1.78|0.94
72537331|NCT03706209|144605306|SUPERIORITY||least square means|-1.1|STANDARD_ERROR_OF_MEAN|1.0||0.267|TWO_SIDED|95.0|-3.1|0.9|||ANCOVA|||Estimates and treatment comparison of least square means using an ANCOVA model, with treatment arm and (pooled) analysis center as factors and baseline outcome as covariate.||0.9|-3.1|0.267
72537332|NCT03706209|144605307|SUPERIORITY||least square means|1.0|STANDARD_ERROR_OF_MEAN|1.2||0.412|TWO_SIDED|95.0|-1.4|3.4|||ANCOVA|||Estimates and treatment comparison of least square means using an ANCOVA model, with treatment arm and (pooled) analysis center as factors and baseline outcome as covariate.||3.4|-1.4|0.412
72537333|NCT03706209|144605307|SUPERIORITY||least square means|-1.0|STANDARD_ERROR_OF_MEAN|1.2||0.401|TWO_SIDED|95.0|-3.5|1.4|||ANCOVA|||Estimates and treatment comparison of least square means using an ANCOVA model, with treatment arm and (pooled) analysis center as factors and baseline outcome as covariate.||1.4|-3.5|0.401
72537334|NCT03706209|144605308|SUPERIORITY||least square means|0.4|STANDARD_ERROR_OF_MEAN|1.7||0.801|TWO_SIDED|95.0|-3.0|3.9|||ANCOVA|||Estimates and treatment comparison of least square means using an ANCOVA model, with treatment arm and (pooled) analysis center as factors and baseline outcome as covariate.||3.9|-3|0.801
72537335|NCT03706209|144605308|SUPERIORITY||least square means|0.1|STANDARD_ERROR_OF_MEAN|1.7||0.957|TWO_SIDED|95.0|-3.4|3.3|||ANCOVA|||Estimates and treatment comparison of least square means using an ANCOVA model, with treatment arm and (pooled) analysis center as factors and baseline outcome as covariate.||3.3|-3.4|0.957
72537336|NCT03706209|144605312|SUPERIORITY||Odds Ratio (OR)|1.45||||0.45|TWO_SIDED|95.0|0.55|3.8|||Cochran-Mantel-Haenszel|||||3.8|0.55|0.45
72537337|NCT03706209|144605312|SUPERIORITY||Odds Ratio (OR)|1.97||||0.186|TWO_SIDED|95.0|0.74|5.26|||Cochran-Mantel-Haenszel|||||5.26|0.74|0.186
72537338|NCT03706209|144605313|SUPERIORITY||Odds Ratio (OR)|0.94||||0.884|TWO_SIDED|95.0|0.41|2.18|||Cochran-Mantel-Haenszel|||||2.18|0.41|0.884
72537339|NCT03706209|144605313|SUPERIORITY||Odds Ratio (OR)|1.49||||0.384|TWO_SIDED|95.0|0.61|3.64|||Cochran-Mantel-Haenszel|||||3.64|0.61|0.384
72537340|NCT03706209|144605314|SUPERIORITY||Odds Ratio (OR)|1.64||||0.311|TWO_SIDED|95.0|0.63|4.26|||Cochran-Mantel-Haenszel|||||4.26|0.63|0.311
72537341|NCT03706209|144605314|SUPERIORITY||Odds Ratio (OR)|1.21||||0.699|TWO_SIDED|95.0|0.47|3.17|||Cochran-Mantel-Haenszel|||||3.17|0.47|0.699
72537342|NCT03706209|144605315|SUPERIORITY||Hodges-Lehmann using location shift|0.0|STANDARD_ERROR_OF_MEAN|0.0||0.671|TWO_SIDED|95.0|0.0|0.0|||Wilcoxon (Mann-Whitney)|||||0|0|0.671
72537343|NCT03706209|144605315|SUPERIORITY||Hodges-Lehmann using location shift|0.0|STANDARD_ERROR_OF_MEAN|0.0||0.183|TWO_SIDED|95.0|0.0|0.0|||Wilcoxon (Mann-Whitney)|||||0|0|0.183
72537344|NCT03706209|144605316|SUPERIORITY||Hodges-Lehmann using location shift|0.0|STANDARD_ERROR_OF_MEAN|0.0||0.542|TWO_SIDED|95.0|0.0|0.0|||Wilcoxon (Mann-Whitney)|||||0|0|0.542
72537345|NCT03706209|144605316|SUPERIORITY||Hodges-Lehmann using location shift|0.0|STANDARD_ERROR_OF_MEAN|0.0||0.328|TWO_SIDED|95.0|0.0|0.0|||Wilcoxon (Mann-Whitney)|||||0|0|0.328
72537346|NCT03706209|144605317|SUPERIORITY||Hodges-Lehmann using location shift|0.0|STANDARD_ERROR_OF_MEAN|0.0||0.921|TWO_SIDED|95.0|0.0|0.0|||Wilcoxon (Mann-Whitney)|||||0|0|0.921
72537347|NCT03706209|144605317|SUPERIORITY||Hodges-Lehmann using location shift|0.0|STANDARD_ERROR_OF_MEAN|0.0||0.488|TWO_SIDED|95.0|0.0|0.0|||Wilcoxon (Mann-Whitney)|||||0|0|0.488
72537348|NCT03706209|144605328|SUPERIORITY|||||||0.1193|||||||Fisher Exact|||||||0.1193
72537349|NCT03706209|144605328|SUPERIORITY|||||||0.0054|||||||Fisher Exact|||||||0.0054
72537350|NCT03706209|144605329|SUPERIORITY|||||||0.2439|||||||Fisher Exact|||||||0.2439
72537351|NCT03706209|144605329|SUPERIORITY|||||||0.2461|||||||Fisher Exact|||||||0.2461
72537352|NCT03706209|144605330|SUPERIORITY|||||||0.4395|||||||Fisher Exact|||||||0.4395
72537353|NCT03706209|144605330|SUPERIORITY|||||||0.0593|||||||Fisher Exact|||||||0.0593
72537354|NCT03706209|144605332|SUPERIORITY|||||||0.0507|||||||Fisher Exact|||||||0.0507
72537355|NCT03706209|144605332|SUPERIORITY|||||||0.0005|||||||Fisher Exact|||||||0.0005
72537356|NCT03706209|144605333|SUPERIORITY|||||||0.0504|||||||Fisher Exact|||||||0.0504
72537357|NCT03706209|144605333|SUPERIORITY|||||||0.0013|||||||Fisher Exact|||||||0.0013
72537358|NCT03706209|144605334|SUPERIORITY|||||||0.098|||||||Fisher Exact|||||||0.098
72537359|NCT03706209|144605334|SUPERIORITY|||||||0.0032|||||||Fisher Exact|||||||0.0032
72537360|NCT03972709|144605344|SUPERIORITY||Difference in Adjusted Means|0.29|STANDARD_ERROR_OF_MEAN|0.188||0.1206||95.0|-0.08|0.66|||MMRM|||||0.66|-0.08|0.1206
72537361|NCT03972709|144605344|SUPERIORITY||Difference in Adjusted Means|0.12|STANDARD_ERROR_OF_MEAN|0.231||0.6127||95.0|-0.34|0.57|||MMRM|||||0.57|-0.34|0.6127
72537362|NCT03972709|144605351|SUPERIORITY||Difference in Adjusted Means|-0.39|STANDARD_ERROR_OF_MEAN|1.901||0.8388|TWO_SIDED|95.0|-4.14|3.36|||MMRM|||||3.36|-4.14|0.8388
72537363|NCT03972709|144605351|SUPERIORITY||Difference in Adjusted Means|-0.48|STANDARD_ERROR_OF_MEAN|2.384||0.8412|TWO_SIDED|95.0|-5.18|4.23|||MMRM|||||4.23|-5.18|0.8412
72537364|NCT03972709|144605352|SUPERIORITY||Difference in Adjusted Means|0.83|STANDARD_ERROR_OF_MEAN|2.052||0.6865|TWO_SIDED|95.0|-3.22|4.88|||MMRM|||||4.88|-3.22|0.6865
72537365|NCT03972709|144605352|SUPERIORITY||Difference in Adjusted Means|0.2|STANDARD_ERROR_OF_MEAN|2.5||0.9355||95.0|-4.73|5.13|||MMRM|||||5.13|-4.73|0.9355
72537366|NCT00345969|144605353|SUPERIORITY_OR_OTHER|||||||0.01|TWO_SIDED||||||ANOVA|||||||0.01
72537367|NCT00345969|144605354|SUPERIORITY_OR_OTHER|||||||0.55|TWO_SIDED||||||ANOVA|||||||0.55
72537368|NCT00345969|144605355|SUPERIORITY_OR_OTHER|||||||0.23|TWO_SIDED||||||ANOVA|||||||0.23
72537369|NCT00345969|144605356|SUPERIORITY_OR_OTHER|||||||0.43|TWO_SIDED||||||ANOVA|||||||0.43
72573592|NCT00911807|144673730|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.45||||0.6962||95.0|-2.719|1.819||No adjustment for multiple testing was needed and all tests were done with retention of the full two-sided alpha-level of 0.05.|t-test, 2 sided|Comparisons between all pair of means were performed with two-sample t-tests within the ANCOVA model.||Multiple testing of individual null hypotheses that control for the overall significance level alpha = 0.05 were performed by using the 'closed testing procedure'.||1.819|-2.719|0.6962
72573593|NCT03970837|144673808|SUPERIORITY||Odds Ratio (OR)|2.57|||<|0.0001|TWO_SIDED|95.0|1.87|3.53|||Regression, Logistic|OR and corresponding 95% CI for OR are generated from the logistic regression model adjusted for Baseline TJC68, Baseline SJC66 and Treatment Group.||The null hypothesis is defined as there is no difference between the 90mg dose of GSK3196165 and placebo in the proportion of participants achieving ACR20 response at Week 12, versus the alternative hypothesis that the 90mg dose of GSK3196165 differs from placebo in the proportion of participants achieving ACR20 response at Week 12.||3.53|1.87|<0.0001
72576786|NCT00261443|144680651|SUPERIORITY_OR_OTHER_LEGACY||Difference|-2.71|||<|0.001|TWO_SIDED|95.0|-4.13|-1.29||Mean change from baseline: ANOVA model, controlling for treatment, mood stabilizer, index mood episode, and baseline value. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 40 Comparison||-1.29|-4.13|<0.001
72537370|NCT00345969|144605357|SUPERIORITY_OR_OTHER|||||||0.33|TWO_SIDED||||||ANOVA|||||||0.33
72537371|NCT00345969|144605358|SUPERIORITY_OR_OTHER|||||||0.93|TWO_SIDED||||||ANOVA|||||||0.93
72537372|NCT00345969|144605359|SUPERIORITY_OR_OTHER|||||||0.24|TWO_SIDED||||||ANOVA|||||||0.24
72537373|NCT00345969|144605360|SUPERIORITY_OR_OTHER|||||||0.49|TWO_SIDED||||||ANOVA|||||||0.49
72537374|NCT00345969|144605361|SUPERIORITY_OR_OTHER|||||||0.19|TWO_SIDED||||||ANOVA|||||||0.19
72537375|NCT00345969|144605362|SUPERIORITY_OR_OTHER|||||||0.71|TWO_SIDED||||||ANOVA|||||||0.71
72537376|NCT00345969|144605363|SUPERIORITY_OR_OTHER|||||||0.44|TWO_SIDED||||||ANOVA|||||||0.44
72537377|NCT00345969|144605364|SUPERIORITY_OR_OTHER|||||||0.89|TWO_SIDED||||||ANOVA|||||||0.89
72537378|NCT00345969|144605365|SUPERIORITY_OR_OTHER|||||||0.13|TWO_SIDED||||||ANOVA|||||||0.13
72537379|NCT02873195|144605396|SUPERIORITY||Hazard Ratio (HR)|0.725||||0.051|TWO_SIDED|95.0|0.491|1.07|||Log Rank|||||1.07|0.491|0.051
72537380|NCT02873195|144605397|SUPERIORITY||Hazard Ratio (HR)|0.94||||0.4|TWO_SIDED|95.0|0.56|1.56|||Log Rank|||||1.56|0.56|0.40
72537381|NCT02873195|144605398|SUPERIORITY|||||||0.4876|||||||Fisher Exact|||||||0.4876
72537382|NCT00752895|144605405|SUPERIORITY_OR_OTHER_LEGACY|||||||0.295|TWO_SIDED|||||This p-value is not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|Negative binomial regression|||||||0.295
72537383|NCT00752895|144605406|SUPERIORITY_OR_OTHER_LEGACY|||||||0.82|TWO_SIDED|||||This p-value is not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|Negative binomial regression|||||||0.820
72537384|NCT03205163|144605428|OTHER||GMR|1.35||||0.032|TWO_SIDED|95.0|1.04|1.77|||ANOVA|||Comparison of Advate and BIVV001 was obtained through analyzing log transformed PK parameters using an analysis of variance (ANOVA) model containing participant and treatment as factors. Geometric mean, 95% confidence interval of geometric mean, and geometric mean ratio (GMR) were the exponentiated mean, 95% confidence interval, and difference of means, respectively.||1.77|1.04|0.032
72537385|NCT03205163|144605429|OTHER||GMR|1.17|||<|0.001|TWO_SIDED|95.0|1.09|1.25|||ANOVA|||Comparison of Advate and BIVV001 was obtained through analyzing log transformed PK parameters using an ANOVA model containing participant and treatment as factors. Geometric mean, 95% confidence interval of geometric mean, and GMR were the exponentiated mean, 95% confidence interval, and difference of means, respectively.||1.25|1.09|<0.001
72537386|NCT03205163|144605430|OTHER||GMR|4.13|||<|0.001|TWO_SIDED|95.0|2.94|5.79|||ANOVA|||Comparison of Advate and BIVV001 was obtained through analyzing log transformed PK parameters using an ANOVA model containing participant and treatment as factors. Geometric mean, 95% confidence interval of geometric mean, and GMR were the exponentiated mean, 95% confidence interval, and difference of means, respectively.||5.79|2.94|<0.001
72537387|NCT03205163|144605431|OTHER||GMR|3.24|||<|0.001|TWO_SIDED|95.0|2.76|3.79|||ANOVA|||Comparison of Advate and BIVV001 was obtained through analyzing log transformed PK parameters using an ANOVA model containing participant and treatment as factors. Geometric mean, 95% confidence interval of geometric mean, and GMR were the exponentiated mean, 95% confidence interval, and difference of means, respectively.||3.79|2.76|<0.001
72537388|NCT03205163|144605432|OTHER||GMR|0.143|||<|0.001|TWO_SIDED|95.0|0.118|0.172|||ANOVA|||Comparison of Advate and BIVV001 was obtained through analyzing log transformed PK parameters using an ANOVA model containing participant and treatment as factors. Geometric mean, 95% confidence interval of geometric mean, and GMR were the exponentiated mean, 95% confidence interval, and difference of means, respectively.||0.172|0.118|<0.001
72537389|NCT03205163|144605433|OTHER||GMR|0.153|||<|0.001|TWO_SIDED|95.0|0.138|0.17|||ANOVA|||Comparison of Advate and BIVV001 was obtained through analyzing log transformed PK parameters using an ANOVA model containing participant and treatment as factors. Geometric mean, 95% confidence interval of geometric mean, and GMR were the exponentiated mean, 95% confidence interval, and difference of means, respectively.||0.170|0.138|<0.001
72537390|NCT03205163|144605434|OTHER||GMR|0.622||||0.003|TWO_SIDED|95.0|0.492|0.786|||ANOVA|||Comparison of Advate and BIVV001 was obtained through analyzing log transformed PK parameters using an ANOVA model containing participant and treatment as factors. Geometric mean, 95% confidence interval of geometric mean, and GMR were the exponentiated mean, 95% confidence interval, and difference of means, respectively.||0.786|0.492|0.003
72537391|NCT03205163|144605435|OTHER||GMR|0.599|||<|0.001|TWO_SIDED|95.0|0.525|0.684|||ANOVA|||Comparison of Advate and BIVV001 was obtained through analyzing log transformed PK parameters using an ANOVA model containing participant and treatment as factors. Geometric mean, 95% confidence interval of geometric mean, and GMR were the exponentiated mean, 95% confidence interval, and difference of means, respectively.||0.684|0.525|<0.001
72537392|NCT03205163|144605436|OTHER||GMR|7.0|||<|0.001|TWO_SIDED|95.0|5.78|8.48|||ANOVA|||Comparison of Advate and BIVV001 was obtained through analyzing log transformed PK parameters using an ANOVA model containing participant and treatment as factors. Geometric mean, 95% confidence interval of geometric mean, and GMR were the exponentiated mean, 95% confidence interval, and difference of means, respectively.||8.48|5.78|<0.001
72537393|NCT03205163|144605437|OTHER||GMR|6.54|||<|0.001|TWO_SIDED|95.0|5.89|7.27|||ANOVA|||Comparison of Advate and BIVV001 was obtained through analyzing log transformed PK parameters using an ANOVA model containing participant and treatment as factors. Geometric mean, 95% confidence interval of geometric mean, and GMR were the exponentiated mean, 95% confidence interval, and difference of means, respectively.||7.27|5.89|<0.001
72537394|NCT03205163|144605438|OTHER||GMR|4.54|||<|0.001|TWO_SIDED|95.0|3.64|5.66|||ANOVA|||Comparison of Advate and BIVV001 was obtained through analyzing log transformed PK parameters using an ANOVA model containing participant and treatment as factors. Geometric mean, 95% confidence interval of geometric mean, and GMR were the exponentiated mean, 95% confidence interval, and difference of means, respectively.||5.66|3.64|<0.001
72573594|NCT03970837|144673808|SUPERIORITY||Odds Ratio (OR)|2.55|||<|0.0001|TWO_SIDED|95.0|1.85|3.5|||Regression, Logistic|OR and corresponding 95% CI for OR are generated from the logistic regression model adjusted for Baseline TJC68, Baseline SJC66 and Treatment Group.||The null hypothesis is defined as there is no difference between the 150mg dose of GSK3196165 and placebo in the proportion of participants achieving ACR20 response at Week 12, versus the alternative hypothesis that the 150mg dose of GSK3196165 differs from placebo in the proportion of participants achieving ACR20 response at Week 12.||3.50|1.85|<0.0001
72369074|NCT02858362|144248137|OTHER|Difference in least square means. All 24 participants in the population were included in the statistical analysis.|Mean Difference (Final Values)|-2.611|||||TWO_SIDED|95.0|-4.324|-0.898||||||Week 24 Change from Baseline||-0.898|-4.324|
72369075|NCT02858362|144248137|OTHER|Difference in least square means. All 16 participants in the population were included in the statistical analysis.|Mean Difference (Final Values)|1.166|||||TWO_SIDED|95.0|-1.103|3.435||||||Week 48 Change from Baseline||3.435|-1.103|
72573595|NCT03970837|144673808|SUPERIORITY||Odds Ratio (OR)|5.38|||<|0.0001|TWO_SIDED|95.0|3.66|7.9|||Regression, Logistic|OR and corresponding 95% CI for OR are generated from the logistic regression model adjusted for Baseline TJC68, Baseline SJC66 and Treatment Group.||The null hypothesis is defined as there is no difference between the 05mg dose of Tofacitinib and placebo in the proportion of participants achieving ACR20 response at Week 12, versus the alternative hypothesis that the 05mg dose of Tofacitinib differs from placebo in the proportion of participants achieving ACR20 response at Week 12.||7.90|3.66|<0.0001
72537395|NCT03205163|144605439|OTHER||GMR|4.32|||<|0.001|TWO_SIDED|95.0|3.96|4.72|||ANOVA|||Comparison of Advate and BIVV001 was obtained through analyzing log transformed PK parameters using an ANOVA model containing participant and treatment as factors. Geometric mean, 95% confidence interval of geometric mean, and GMR were the exponentiated mean, 95% confidence interval, and difference of means, respectively.||4.72|3.96|<0.001
72537396|NCT03205163|144605440|OTHER||GMR|1.36||||0.063|TWO_SIDED|95.0|0.978|1.89|||ANOVA|||Comparison of Advate and BIVV001 was obtained through analyzing log transformed PK parameters using an ANOVA model containing participant and treatment as factors. Geometric mean, 95% confidence interval of geometric mean, and GMR were the exponentiated mean, 95% confidence interval, and difference of means, respectively.||1.89|0.978|0.063
72626858|NCT04464473|144782791|SUPERIORITY|||||||0.1339|||||||ANOVA|Interaction of visit (Baseline, MFG-cTBS, FPl-cTBS, S1-cTBS), contextual control, and subsystem on BOLD activation||||||0.1339
72626859|NCT04464473|144782791|SUPERIORITY|||||||0.1315|||||||ANOVA|Interaction of visit, temporal control, contextual control, and subsystem on BOLD activation||||||0.1315
72626860|NCT04464473|144782791|SUPERIORITY|||||||0.6836|||||||ANOVA|The main effect of intervention arm (FPl-TMS, MFG-TMS, S1-TMS) on overall BOLD activation.||||||0.6836
72626861|NCT04464473|144782791|SUPERIORITY|||||||0.2146|||||||ANOVA|Interaction of intervention (MFG-cTBS, FPl-cTBS, S1-cTBS) and subsystem (temporal, contextual, sensorimotor control) on overall BOLD activation.||||||0.2146
72626862|NCT04464473|144782791|SUPERIORITY|||||||0.1541|||||||ANOVA|Interaction of intervention (MFG-cTBS, FPl-cTBS, S1-cTBS) and temporal control on BOLD activation||||||0.1541
72626863|NCT04464473|144782791|SUPERIORITY|||||||0.6657|||||||ANOVA|Interaction of intervention (MFG-cTBS, FPl-cTBS, S1-cTBS) and contextual control on BOLD activation||||||0.6657
72626864|NCT04464473|144782791|SUPERIORITY|||||||0.5619|||||||ANOVA|Interaction of intervention (MFG-cTBS, FPl-cTBS, S1-cTBS), temporal control, and contextual control on BOLD activation||||||0.5619
72537397|NCT03205163|144605441|OTHER||GMR|1.18|||<|0.001|TWO_SIDED|95.0|1.1|1.26|||ANOVA|||Comparison of Advate and BIVV001 was obtained through analyzing log transformed PK parameters using an ANOVA model containing participant and treatment as factors. Geometric mean, 95% confidence interval of geometric mean, and GMR were the exponentiated mean, 95% confidence interval, and difference of means, respectively.||1.26|1.10|<0.001
72537398|NCT03205163|144605442|OTHER||GMR|4.57|||<|0.001|TWO_SIDED|95.0|4.0|5.23|||ANOVA|||Comparison of Advate and BIVV001 was obtained through analyzing log transformed PK parameters using an ANOVA model containing participant and treatment as factors. Geometric mean, 95% confidence interval of geometric mean, and GMR were the exponentiated mean, 95% confidence interval, and difference of means, respectively.||5.23|4.00|<0.001
72537399|NCT03205163|144605443|OTHER||GMR|4.46|||<|0.001|TWO_SIDED|95.0|4.16|4.79|||ANOVA|||Comparison of Advate and BIVV001 was obtained through analyzing log transformed PK parameters using an ANOVA model containing participant and treatment as factors. Geometric mean, 95% confidence interval of geometric mean, and GMR were the exponentiated mean, 95% confidence interval, and difference of means, respectively.||4.79|4.16|<0.001
72537400|NCT05257109|144605444|OTHER|Mixed effects models with water concentration as the within subject factor and irritation as outcome. Outcome analyses will be intent-to-treat and using mixed-effects models. If model assumptions will appear to be violated, we will transform the data or fit more flexible generalized linear or nonparametric mixed models. A significant main effect of condition will be considered supportive of our hypothesis. Formal power analyses were not conducted for this pilot study.|Median Difference (Final Values)|0.67||||0.0014|TWO_SIDED|||||Significant p-value set at \<0.05|Mixed Models Analysis|||||||0.0014
72537401|NCT05257109|144605445|OTHER|Mixed effects models with water concentration as the within subject factor and LHS as outcome. Outcome analyses will be intent-to-treat and using mixed-effects models. If model assumptions will appear to be violated, we will transform the data or fit more flexible generalized linear or nonparametric mixed models. A significant main effect of condition will be considered supportive of our hypothesis. Formal power analyses were not conducted for this pilot study.|Mean Difference (Final Values)|1.55|||<|0.05|TWO_SIDED||||||Mixed Models Analysis|||||||<.05
72537402|NCT05257109|144605446|OTHER|Mixed effects models with water concentration as the within subject factor and DEQ as outcome. Outcome analyses will be intent-to-treat and using mixed-effects models. If model assumptions will appear to be violated, we will transform the data or fit more flexible generalized linear or nonparametric mixed models. A significant main effect of condition will be considered supportive of our hypothesis. Formal power analyses were not conducted for this pilot study.|Mean Difference (Final Values)|3.28|||<|0.05|TWO_SIDED||||||Mixed Models Analysis|||||||<.05
72537403|NCT00584831|144605447|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin is 0.05|Mean Difference (Final Values)|0.03|STANDARD_DEVIATION|0.16||0.02||95.0|||||ANOVA|||Hypothesis is that visual acuity is the same for all lens types.||||0.02
72573596|NCT03970837|144673808|SUPERIORITY||Odds Ratio (OR)|0.48|||<|0.0001|TWO_SIDED|95.0|0.34|0.66|||Regression, Logistic|OR and corresponding 95% CI for OR are generated from the logistic regression model adjusted for Baseline TJC68, Baseline SJC66 and Treatment Group.||The null hypothesis is defined as there is no difference between the 90 mg dose of GSK3196165 and 05mg dose of Tofacitinib in the proportion of participants achieving ACR20 response at Week 12, versus the alternative hypothesis that the 90 mg dose of GSK3196165 differs from 05mg dose of Tofacitinib in the proportion of participants achieving ACR20 response at Week 12.||0.66|0.34|<0.0001
72537404|NCT00584831|144605447|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin is 0.05|Mean Difference (Final Values)|-0.04|STANDARD_DEVIATION|0.18||0.02||95.0|||||ANOVA|||Hyposthesis is that visual acuity is the same for all lens types.||||0.02
72537405|NCT00584831|144605447|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin is 0.05|Mean Difference (Final Values)|-0.02|STANDARD_DEVIATION|0.2||0.02||95.0|||||ANOVA|||Hypothesis is that visual acuity is the same for all lens types.||||0.02
72537406|NCT00584831|144605447|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin is 0.05|Mean Difference (Final Values)|-0.06|STANDARD_DEVIATION|0.17||0.02||95.0|||||ANOVA|||Hypothesis is that visual acuity is the same for all lens types.||||0.02
72573597|NCT03970837|144673808|SUPERIORITY||Odds Ratio (OR)|0.47|||<|0.0001|TWO_SIDED|95.0|0.34|0.66|||Regression, Logistic|OR and corresponding 95% CI for OR are generated from the logistic regression model adjusted for Baseline TJC68, Baseline SJC66 and Treatment Group.||The null hypothesis is defined as there is no difference between the 150mg dose of GSK3196165 and 05mg dose of Tofacitinib in the proportion of participants achieving ACR20 response at Week 12, versus the alternative hypothesis that the 150mg dose of GSK3196165 differs from 05mg dose of Tofacitinib in the proportion of participants achieving ACR20 response at Week 12.||0.66|0.34|<0.0001
72573598|NCT03970837|144673812|NON_INFERIORITY|Non-inferiority over tofacitinib on ACR20 was concluded if the lower limit of the multiplicity corrected 95% Confidence Interval (CI) in the difference in proportions (GSK3196165 minus tofacitinib) was greater than -12%|Difference in Percentage|-14.7|||||TWO_SIDED|95.0|-21.3|-8.1|||Regression, Logistic|Difference in proportion and 95% CI are generated from logistic regression model adjusted for Baseline TJC68, Baseline SJC66 and Treatment Group.||||-8.1|-21.3|
72573599|NCT03970837|144673812|NON_INFERIORITY|Non-inferiority over tofacitinib on ACR20 was concluded if the lower limit of the multiplicity corrected 95% Confidence Interval (CI) in the difference in proportions (GSK3196165 minus tofacitinib) was greater than -12%|Difference in Percentage|-17.2|||||TWO_SIDED|95.0|-23.9|-10.6|||Regression, Logistic|Difference in proportion and 95% CI are generated from logistic regression model adjusted for Baseline TJC68, Baseline SJC66 and Treatment Group.||||-10.6|-23.9|
72537407|NCT00584831|144605447|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin is 0.05|Mean Difference (Final Values)|-0.04|STANDARD_DEVIATION|0.18||0.02||95.0|||||ANOVA|||Hypothesis is that visual acuity is the same for all lens types.||||0.02
72537408|NCT00584831|144605447|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin is 0.05|Mean Difference (Final Values)|0.02|STANDARD_DEVIATION|0.18||0.02||95.0|||||ANOVA|||Hypothesis is that visual acuity is the same for all lens types.||||0.02
72537409|NCT00584831|144605448|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin is 0.05|Mean Difference (Final Values)|0.02|STANDARD_DEVIATION|0.16||0.02||95.0|||||ANOVA|||Hypothesis is that visual acuity is the same for all lens types.||||0.02
72573600|NCT01997229|144673997|SUPERIORITY||Mean Difference (Net)|-11.7||||0.0698|TWO_SIDED|95.0|-24.33|0.96|||ANCOVA|||||0.96|-24.33|0.0698
72573601|NCT02304991|144673998|SUPERIORITY|||||||0.002|||||||t-test, 2 sided|||Intent to treat; participants not completing the DBPCFC considered to have challenge score of zero||||0.002
72537410|NCT00584831|144605448|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin is 0.05|Mean Difference (Final Values)|-0.01|STANDARD_DEVIATION|0.17||0.02||95.0|||||ANOVA|||Hypothesis is that visual acuity is the same for all lens types.||||0.02
72537411|NCT00584831|144605448|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin is 0.05|Mean Difference (Final Values)|-0.03|STANDARD_DEVIATION|0.17||0.02||95.0|||||ANOVA|||Hypothesis is that visual acuity is the same for all lens types.||||0.02
72537412|NCT00584831|144605448|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin is 0.05|Mean Difference (Final Values)|-0.03|STANDARD_DEVIATION|0.19||0.02||95.0|||||ANOVA|||Hypothesis is that visual acuity is the same for all lens types.||||0.02
72537413|NCT00584831|144605448|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin is 0.05|Mean Difference (Final Values)|-0.04|STANDARD_DEVIATION|0.2||0.02||95.0|||||ANOVA|||Hypothesis is that visual acuity is the same for all lens types.||||0.02
72537414|NCT00584831|144605448|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin is 0.05|Mean Difference (Final Values)|-0.02|STANDARD_DEVIATION|0.17||0.02||95.0|||||ANOVA|||Hypothesis is that visual acuity is the same for all lens types.||||0.02
72537415|NCT00584831|144605449|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin is 0.05|Mean Difference (Final Values)|0.03|STANDARD_DEVIATION|0.13||0.02||95.0|||||ANOVA|||Hypothesis is that visual acuity is the same for all lens types.||||0.02
72537416|NCT00584831|144605449|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin is 0.05|Mean Difference (Final Values)|-0.01|STANDARD_DEVIATION|0.15||0.02||95.0|||||ANOVA|||Hypothesis is that visual acuity is the same for all lens types.||||0.02
72537417|NCT00584831|144605449|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin is 0.05|Mean Difference (Final Values)|-0.02|STANDARD_DEVIATION|0.17||0.02||95.0|||||ANOVA|||Hypothesis is that visual acuity is the same for all lens types.||||0.02
72537418|NCT00584831|144605449|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin is 0.05|Mean Difference (Final Values)|-0.04|STANDARD_DEVIATION|0.15||0.02||95.0|||||ANOVA|||Hypothesis is that visual acuity is the same for all lens types.||||0.02
72537419|NCT00584831|144605449|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin is 0.05|Mean Difference (Final Values)|-0.06|STANDARD_DEVIATION|0.17||0.02||95.0|||||ANOVA|||Hypothesis is that visual acuity is the same for all lens types.||||0.02
72537420|NCT00584831|144605449|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin is 0.05|Mean Difference (Final Values)|-0.01|STANDARD_DEVIATION|0.18||0.02||95.0|||||ANOVA|||Hypothesis is that visual acuity is the same for all lens types.||||0.02
72537421|NCT00584831|144605450|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin is 0.05|Mean Difference (Final Values)|0.04|STANDARD_DEVIATION|0.17||0.02||95.0|||||ANOVA|||Hypothesis is that visual acuity is the same for all lens types.||||0.02
72537422|NCT00584831|144605450|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin is 0.05|Mean Difference (Final Values)|-0.01|STANDARD_DEVIATION|0.19||0.02||95.0|||||ANOVA|||Hypothesis is that visual acuity is the same for all lens types.||||0.02
72537423|NCT00584831|144605450|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin is 0.05|Mean Difference (Final Values)|-0.02|STANDARD_DEVIATION|0.2||0.02||95.0|||||ANOVA|||Hypothesis is that visual acuity is the same for all lens types.||||0.02
72537424|NCT00584831|144605450|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin is 0.05|Mean Difference (Final Values)|-0.05|STANDARD_DEVIATION|0.15||0.02||95.0|||||ANOVA|||Hypothesis is that visual acuity is the same for all lens types.||||0.02
72537425|NCT00584831|144605450|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin is 0.05|Mean Difference (Final Values)|-0.06|STANDARD_DEVIATION|0.18||0.02||95.0|||||ANOVA|||Hypothesis is that visual acuity is the same for all lens types.||||0.02
72537426|NCT00584831|144605450|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin is 0.05|Mean Difference (Final Values)|-0.01|STANDARD_DEVIATION|0.18||0.02||95.0|||||ANOVA|||Hypothesis is that visual acuity is the same for all lens types.||||0.02
72537427|NCT01371006|144605475|NON_INFERIORITY_OR_EQUIVALENCE|investigation of relative bioavailability (no formal testing)|Geometric Mean Ratio|105.61|STANDARD_DEVIATION|22.0|||TWO_SIDED|90.0|90.81|122.82|||ANOVA||the standard deviation is actually the geometric coefficient of variation|relative bioavailability comparison (50 mg Efavirenz+240 mg Faldaprevir : 50 mg Efavirenz) of Efavirenz||122.82|90.81|
72537428|NCT01371006|144605476|NON_INFERIORITY_OR_EQUIVALENCE|investigation of relative bioavailability (no formal testing)|Geometric Mean Ratio|116.12|STANDARD_DEVIATION|18.8|||TWO_SIDED|90.0|101.87|132.35|||ANOVA||the standard deviation is actually the geometric coefficient of variation|relative bioavailability comparison (50 mg Efavirenz+240 mg Faldaprevir : 50 mg Efavirenz) of Efavirenz||132.35|101.87|
72537429|NCT01371006|144605477|NON_INFERIORITY_OR_EQUIVALENCE|investigation of relative bioavailability (no formal testing)|Geometric Mean Ratio|71.83|STANDARD_DEVIATION|23.6|||TWO_SIDED|90.0|61.46|83.95|||ANOVA||the standard deviation is actually the geometric coefficient of variation|relative bioavailability comparison (7.5 mg Midazolam+240 mg Faldaprevir+600 mg Efavirenz : 7.5 mg Midazolam+240 mg Faldaprevir) of Faldaprevir||83.95|61.46|
72537430|NCT01371006|144605478|NON_INFERIORITY_OR_EQUIVALENCE|investigation of relative bioavailability (no formal testing)|Geometric Mean Ratio|64.97|STANDARD_DEVIATION|30.2|||TWO_SIDED|90.0|53.32|79.16|||ANOVA||the standard deviation is actually the geometric coefficient of variation|relative bioavailability comparison (7.5 mg Midazolam+240 mg Faldaprevir+600 mg Efavirenz : 7.5 mg Midazolam+240 mg Faldaprevir) of Faldaprevir||79.16|53.32|
72573602|NCT02304991|144673999|SUPERIORITY|||||||0.0005|||||||t-test, 2 sided|||Intent to treat; participants not completing the DBPCFC considered to have challenge score of zero||||0.0005
72573603|NCT02304991|144674000|SUPERIORITY|||||||0.007|||||||t-test, 2 sided|||||||0.007
72573604|NCT02304991|144674001|SUPERIORITY|||||||0.01|||||||t-test, 2 sided|||Per protocol analysis of patients with available samples.||||0.01
72573605|NCT02304991|144674002|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||Per protocol analysis of patients with available samples.||||<0.0001
72573606|NCT02304991|144674003|SUPERIORITY|||||||0.3|||||||t-test, 2 sided|||||||0.3
72573607|NCT04430855|144674004|SUPERIORITY||Response Rate Difference|13.3||||0.018|TWO_SIDED|95.0|-0.6|27.2|||Chi-squared||Response rate difference compared to historical placebo = upadacitinib 30 mg - historical placebo|The primary analysis compared the percentage of participants in the upadacitinib 30 mg treatment group who achieved HiSCR response to that of a prespecified, single historical placebo rate (25%). The historical placebo rate of 25% was assumed based on the corresponding response rates of placebo participants satisfying the same key eligibility criteria from the 2 adalimumab HS Phase 3 studies, Study M11-313 (NCT01468207) and Study M11-810 (NCT01468233).||27.2|-0.6|0.018
72537431|NCT01371006|144605479|NON_INFERIORITY_OR_EQUIVALENCE|investigation of relative bioavailability (no formal testing)|Geometric Mean Ratio|54.31|STANDARD_DEVIATION|44.2|||TWO_SIDED|90.0|40.47|72.88|||ANOVA||the standard deviation is actually the geometric coefficient of variation|relative bioavailability comparison (7.5 mg Midazolam+240 mg Faldaprevir+600 mg Efavirenz : 7.5 mg Midazolam+240 mg Faldaprevir) of Faldaprevir||72.88|40.47|
72537432|NCT00915473|144605492|SUPERIORITY_OR_OTHER|||||||0.98|||||||Chi-squared|||||||0.98
72537433|NCT00915473|144605493|SUPERIORITY_OR_OTHER|||||||0.52|||||||t-test, 2 sided|||Severe Migraine Frequency||||0.52
72537434|NCT00915473|144605493|SUPERIORITY_OR_OTHER|||||||0.52|||||||t-test, 2 sided|||At least Moderate Migraine Frequency||||0.52
72537435|NCT00915473|144605493|SUPERIORITY_OR_OTHER|||||||0.47|||||||t-test, 2 sided|||At Least Mild Migraine Frequency||||0.47
72537436|NCT00915473|144605494|SUPERIORITY_OR_OTHER|||||||0.9|||||||t-test, 2 sided|||||||0.90
72537437|NCT00915473|144605495|SUPERIORITY_OR_OTHER|||||||0.47|||||||t-test, 2 sided|||||||0.47
72537438|NCT03515837|144605496|SUPERIORITY||Hazard Ratio (HR)|0.8||||0.0122|TWO_SIDED|95.0|0.65|0.97|||Log Rank|One-sided p-value based on log-rank test stratified by PD-L1 expression; treatment history; geographic region of the enrolling site.|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by PD-L1 expression; treatment history; geographic region of the enrolling site.|||0.97|0.65|0.0122
72537439|NCT03515837|144605497|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.0362|TWO_SIDED|95.0|0.69|1.02|||Log Rank|One-sided p-value based on log-rank test stratified by PD-L1 expression; treatment history; geographic region of the enrolling site.|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by PD-L1 expression; treatment history; geographic region of the enrolling site.|||1.02|0.69|0.0362
72537440|NCT03515837|144605498|SUPERIORITY||Mean Difference (Final Values)|1.9|||||TWO_SIDED|95.0|-6.0|9.9|||||Based on Miettinen \& Nurminen method stratified by PD-L1 expression; treatment history; geographic region of the enrolling site.|||9.9|-6.0|
72537441|NCT03515837|144605500|OTHER||Difference in LS Means|1.59|||||TWO_SIDED|95.0|-1.93|5.1|||||Based on a cLDA model with the PRO scores as the response variable with covariates for treatment by time interaction, stratification factors PD-L1 expression, treatment history, and geographic region of the enrolling site as covariates.|||5.10|-1.93|
72537442|NCT03515837|144605501|OTHER||Hazard Ratio (HR)|0.93||||||95.0|0.68|1.27|||||Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by PD-L1 expression; treatment history; geographic region of the enrolling site.|||1.27|0.68|
72537443|NCT03443973|144605524|SUPERIORITY||Difference in Adjusted mean|-0.19|STANDARD_ERROR_OF_MEAN|0.18||0.2998|TWO_SIDED|95.0|-0.55|0.17|||ANCOVA|||Change from Baseline was calculated based on ANCOVA analysis model which included the following covariates and stratification factors =Treatment + Baseline (BL) + Geographic Region + Disease Stage + AD Medication at BL + Apolipoprotein E, Allele e4 (APOE e4) + Baseline ADAS COG13 + Baseline Alzheimer Disease Cooperative Study Group-Activities of Daily Living (ADCS-ADL).||0.17|-0.55|0.2998
72573608|NCT04430855|144674004|SUPERIORITY||Adjusted Response Rate Difference|9.2||||0.142|TWO_SIDED|95.0|-7.6|25.9|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline Hurley Stage \[Stage \< III, Stage III\] and prior TNF use \[Yes or No\])|Response rate difference = upadacitinib 30 mg - placebo (in-trial + synthetic)|As a supplemental analysis, the percentage of participants who achieved HiSCR at Week 12 was further analyzed by comparing upadacitinib with in-trial placebo participants combined with subjects with historical placebo HiSCR data pre-selected using propensity score matching from adalimumab studies M11-313 and M11-810 and risankizumab study M16-833 (NCT03926169), whose study populations, entry criteria and study designs were similar to this study. The placebo in-trial + synthetic HiSCR was 29.2%.||25.9|-7.6|0.142
72626865|NCT04464473|144782791|SUPERIORITY|||||||0.5148|||||||ANOVA|Interaction of intervention (MFG-cTBS, FPl-cTBS, S1-cTBS), temporal control, and subsystem (temporal, contextual, sensorimotor) on BOLD activation||||||0.5148
72369076|NCT02858362|144248138|OTHER|Difference in least square means. All 24 participants in the population were included in the statistical analysis.|Mean Difference (Final Values)|-1.837|||||TWO_SIDED|95.0|-3.989|0.315||||||Week 24 Change from Baseline||0.315|-3.989|
72537444|NCT03443973|144605530|SUPERIORITY||Difference in adjusted mean|-1.28|STANDARD_ERROR_OF_MEAN|0.58||0.0273|TWO_SIDED|95.0|-2.41|-0.14|||ANCOVA|||Change from BL was calculated based on ANCOVA analysis model which included the following covariates and stratification factors = Treatment + Baseline + Geographical Region + Disease Stage + AD Medication at BL + APOE e4||-0.14|-2.41|0.0273
72537445|NCT03443973|144605531|SUPERIORITY||Difference in adjusted mean|0.82|STANDARD_ERROR_OF_MEAN|0.78||0.2918|TWO_SIDED|95.0|-0.7|2.34|||ANCOVA|||Change from BL was calculated based on ANCOVA analysis model which included the following covariates and stratification factors = Treatment + Baseline + Region + Disease Stage + AD Medication at BL + APOE e4||2.34|-0.70|0.2918
72369077|NCT02858362|144248138|OTHER|Difference in least square means. All 16 participants in the population were included in the statistical analysis.|Mean Difference (Final Values)|2.21|||||TWO_SIDED|95.0|0.096|4.324||||||Week 48 Change from Baseline||4.324|0.096|
72537446|NCT03443973|144605532|SUPERIORITY||Difference in adjusted mean|-0.86|STANDARD_ERROR_OF_MEAN|0.43||0.0438|TWO_SIDED|95.0|-1.7|-0.02|||ANCOVA|||Change from BL was calculated based on ANCOVA analysis model which included the following covariates and stratification factors = Treatment + Baseline + Geographical Region + Disease Stage + AD Medication at BL + APOE e4.||-0.02|-1.70|0.0438
72537447|NCT03443973|144605533|SUPERIORITY||Difference in adjusted mean|0.52|STANDARD_ERROR_OF_MEAN|0.27||0.0566|TWO_SIDED|95.0|-0.01|1.06|||ANCOVA|||Change from Baseline was calculated based on ANCOVA analysis model which included the following covariates and stratification factors =Treatment + Baseline + Geographic Region + Disease Stage + AD Medication at BL + APOE e4.||1.06|-0.01|0.0566
72537448|NCT03443973|144605534|SUPERIORITY||Difference in adjusted mean|-1.19|STANDARD_ERROR_OF_MEAN|0.53||0.026|TWO_SIDED|95.0|-2.24|-0.14|||ANCOVA|||Change from BL was calculated based on ANCOVA analysis model which included the following covariates and stratification factors = Treatment + Baseline + Geographical Region + Disease Stage + AD Medication at BL + APOE e4.||-0.14|-2.24|0.0260
72537449|NCT03443973|144605535|SUPERIORITY||Difference in adjusted mean|-0.03|STANDARD_ERROR_OF_MEAN|0.28||0.9086|TWO_SIDED|95.0|-0.59|0.52|||ANCOVA|||Change from BL was calculated based on ANCOVA analysis model which included the following covariates and stratification factors = Treatment + Baseline + Geographical Region + Disease Stage + AD Medication at BL + APOE e4.||0.52|-0.59|0.9086
72537450|NCT03443973|144605536|SUPERIORITY||Difference in adjusted mean|1.41|STANDARD_ERROR_OF_MEAN|0.76||0.0629|TWO_SIDED|95.0|-0.08|2.9|||ANCOVA|||Change from BL was calculated based on ANCOVA analysis model which included the following covariates and stratification factors = Treatment + Baseline + Geographical Region + Disease Stage + AD Medication at BL + APOE e4.||2.90|-0.08|0.0629
72537451|NCT03443973|144605537|SUPERIORITY||Difference in adjusted mean|0.79|STANDARD_ERROR_OF_MEAN|0.66||0.2348|TWO_SIDED|95.0|-0.51|2.09|||ANCOVA|||Change from BL was calculated based on ANCOVA analysis model which included the following covariates and stratification factors = Treatment + Baseline + Geographical Region + Disease Stage + AD Medication at BL + APOE e4.||2.09|-0.51|0.2348
72537452|NCT03443973|144605544|SUPERIORITY||Difference in adjusted means|-56.46|STANDARD_ERROR_OF_MEAN|3.976|<|0.0001|TWO_SIDED|95.0|-64.36|-48.56|||Mixed Model for Repeated Measures|||Change from BL was calculated based on mixed-effect model of repeated measure which included the following covariates and stratification factors = Baseline + APOE e4 status + Type of Tracer + Analysis Visit + Treatment + Treatment\*Analysis Visit + Analysis Visit\*Baseline.||-48.56|-64.36|<.0001
72537453|NCT03443973|144605545|SUPERIORITY||Difference in adjusted mean|0.01|STANDARD_ERROR_OF_MEAN|0.023||0.7816|TWO_SIDED|95.0|-0.04|0.05|||Mixed Model for Repeated Measures|||Temporal Composite Region: Change from BL was calculated based on mixed-effect model of repeated measure which included the following covariates and stratification factors = Baseline + APOE e4 status + Study + Analysis Visit + Treatment + Treatment\*Analysis Visit + Analysis Visit\*Baseline.||0.05|-0.04|0.7816
72537454|NCT03443973|144605545|SUPERIORITY||Difference in adjusted means|0.01|STANDARD_ERROR_OF_MEAN|0.018||0.6203|TWO_SIDED|95.0|-0.03|0.05|||Mixed Model for Repeated Measures|||Medial Temporal Composite Region: Change from BL was calculated based on mixed-effect model of repeated measure which included the following covariates and stratification factors = Baseline + APOE e4 status + Study + Analysis Visit + Treatment + Treatment\*Analysis Visit + Analysis Visit\*Baseline.||0.05|-0.03|0.6203
72537455|NCT03443973|144605545|SUPERIORITY||Difference in adjusted means|0.0|STANDARD_ERROR_OF_MEAN|0.015||0.7754|TWO_SIDED|95.0|-0.03|0.03|||Mixed Model for Repeated Measures|||Frontal Lobe: Change from BL was calculated based on mixed-effect model of repeated measure which included the following covariates and stratification factors = Baseline + APOE e4 status + Study + Analysis Visit + Treatment + Treatment\*Analysis Visit + Analysis Visit\*Baseline.||0.03|-0.03|0.7754
72537456|NCT03443973|144605545|SUPERIORITY||Difference in adjusted means|0.0|STANDARD_ERROR_OF_MEAN|0.026||0.9022|TWO_SIDED|95.0|-0.05|0.05|||Mixed Model for Repeated Measures|||Parietal Lobe: Change from BL was calculated based on mixed-effect model of repeated measure which included the following covariates and stratification factors = Baseline + APOE e4 status + Study + Analysis Visit + Treatment + Treatment\*Analysis Visit + Analysis Visit\*Baseline.||0.05|-0.05|0.9022
72537457|NCT03443973|144605546|SUPERIORITY||Percent Difference in Geometric Mean|-13.2||||0.014|TWO_SIDED|95.0|-22.51|-2.87|||ANCOVA|||||-2.87|-22.51|0.014
72537458|NCT03443973|144605547|SUPERIORITY||Percent Difference in Geometric Mean|-14.4|||<|0.001|TWO_SIDED|95.0|-21.88|-6.21|||ANCOVA|||||-6.21|-21.88|<0.001
72537459|NCT03443973|144605548|SUPERIORITY||Percent Difference in Geometric Mean|-17.8|||<|0.001|TWO_SIDED|95.0|-24.92|-10.11|||ANCOVA|||||-10.11|-24.92|<0.001
72537460|NCT03443973|144605549|SUPERIORITY||Percent Difference in Geometric Mean|-21.0|||<|0.001|TWO_SIDED|95.0|-28.29|-12.97|||ANCOVA|||||-12.97|-28.29|<0.001
72537461|NCT00366678|144605573|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|0.0||||||95.0|-1.4|1.4||||||For Pertussis - PT the difference in percentages between the two groups (13vPnC - 7vPnC) at (≥5 EU/mL) threshold was calculated||1.4|-1.4|
72537462|NCT00366678|144605573|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|-0.7||||||95.0|-4.8|3.3||||||For Pertussis - PTf the difference in percentages between the two groups (13vPnC - 7vPnC) at (≥26.00 EU/mL) threshold was calculated||3.3|-4.8|
72537463|NCT00366678|144605573|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|0.0||||||95.0|-1.4|1.4||||||For Pertussis - FHA the difference in percentages between the two groups (13vPnC - 7vPnC) at (≥5 EU/mL) threshold was calculated||1.4|-1.4|
72573609|NCT04430855|144674004|SUPERIORITY||Adjusted Response Rate Difference|14.7||||0.087|TWO_SIDED|95.0|-6.6|36.0|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline Hurley Stage \[Stage \< III, Stage III\] and prior TNF use \[Yes or No\])|Response rate difference = upadacitinib 30 mg - placebo|As an additional supplemental analysis, the percentage of participants who achieved HiSCR at Week 12 was also analyzed by comparing upadacitinib 30 mg with in-trial placebo participants.||36.0|-6.6|0.087
72573610|NCT04430855|144674005|SUPERIORITY||Response Rate Difference|13.9||||0.028|TWO_SIDED|95.0|-2.5|30.3|||Chi-squared||Response rate difference compared to historical placebo (upadacitinib 30 mg - historical placebo)|The primary analysis compared the percentage of participants in the upadacitinib 30 mg treatment group who achieved NRS30 response to that of a prespecified, single historical placebo rate (22.5%). The historical placebo rate of 22.5% was assumed based on the corresponding response rates of placebo participants satisfying the same key eligibility criteria from the 2 adalimumab HS Phase 3 studies, Study M11-313 (NCT01468207) and Study M11-810 (NCT01468233).||30.3|-2.5|0.028
72573611|NCT04430855|144674005|SUPERIORITY||Adjusted Response Rate Difference|4.5||||0.323|TWO_SIDED|95.0|-14.6|23.5||Cochran-Mantel-Haenszel test adjusted for strata (Baseline Hurley Stage \[Stage \< III, Stage III\] and prior TNF use \[Yes or No\])|Cochran-Mantel-Haenszel||Response rate difference = upadacitinib 30 mg - placebo (in-trial + synthetic)|As a supplemental analysis, the percentage of participants who achieved NRS30 at Week 12 was further analyzed by comparing upadacitinib with in-trial placebo participants combined with subjects with historical placebo NRS30 data pre-selected using propensity score matching from adalimumab studies M11-313 and M11-810 and risankizumab study M16-833 (NCT03926169), whose study populations, entry criteria and study designs were similar to this study. The placebo in-trial + synthetic NRS30 was 31.3%.||23.5|-14.6|0.323
72626866|NCT04464473|144782791|SUPERIORITY|||||||0.5428|||||||ANOVA|Interaction of intervention (MFG-cTBS, FPl-cTBS, S1-cTBS), contextual control, and subsystem (temporal, contextual, sensorimotor) on BOLD activation||||||0.5428
72626867|NCT04464473|144782791|SUPERIORITY|||||||0.1249|||||||ANOVA|Interaction of intervention, temporal control, contextual control, and subsystem on BOLD activation||||||0.1249
72573612|NCT04430855|144674005|SUPERIORITY||Adjusted Response Rate Difference|2.2||||0.421|TWO_SIDED|95.0|-19.6|24.0|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline Hurley Stage \[Stage \< III, Stage III\] and prior TNF use \[Yes or No\])|Response rate difference = upadacitinib 30 mg - placebo|As an additional supplemental analysis, the percentage of participants who achieved NRS30 at Week 12 was also analyzed by comparing upadacitinib 30 mg with in-trial placebo participants.||24.0|-19.6|0.421
72573613|NCT04874636|144674016|SUPERIORITY||Posterior Mean Difference|0.08|||||TWO_SIDED|95.0|-0.59|0.75|||||Posterior mean difference with 95% credible interval is reported.|||0.75|-0.59|
72573614|NCT04874636|144674017|SUPERIORITY||Posterior Mean Difference|0.49|||||TWO_SIDED|95.0|-1.02|2.0|||||Posterior mean difference with 95% credible interval is reported.|||2.00|-1.02|
72573615|NCT04874636|144674018|SUPERIORITY||Posterior Mean Difference|0.14|||||TWO_SIDED|95.0|-0.27|0.55|||||Posterior mean difference with 95% credible interval is reported.|||0.55|-0.27|
72573616|NCT04874636|144674019|SUPERIORITY||Posterior Mean Difference|0.29|||||TWO_SIDED|95.0|-0.43|1.02|||||Posterior mean difference with 95% credible interval is reported.|||1.02|-0.43|
72573617|NCT04874636|144674020|SUPERIORITY||Posterior Mean Difference|7.9|||||TWO_SIDED|95.0|-0.32|16.14|||||Posterior mean difference with 95% credible interval is reported.|||16.14|-0.32|
72573618|NCT04874636|144674021|SUPERIORITY||Posterior Mean Difference|-0.17|||||TWO_SIDED|95.0|-0.65|0.3|||||Posterior mean difference with 95% credible interval is reported.|||0.30|-0.65|
72573619|NCT04874636|144674022|SUPERIORITY||Posterior Mean Difference|-34.98|||||TWO_SIDED|95.0|-176.34|106.69|||||Posterior mean difference with 95% credible interval is reported.|||106.69|-176.34|
72573620|NCT04874636|144674023|SUPERIORITY||Posterior Mean Difference|0.0|||||TWO_SIDED|95.0|-0.1|0.09|||||Posterior mean difference with 95% credible interval is reported.|||0.09|-0.10|
72573621|NCT01770392|144674024|SUPERIORITY_OR_OTHER||Geometric Mean Ratio in percentage|50.12|STANDARD_DEVIATION|12.7||1|TWO_SIDED|90.0|47.155|53.275||p-value for ratio outside interval 0.8 - 1.25|ANOVA|"The model includes fixed effect for treatment and effect subjects was considered as random"|"The standard deviation is actually the geometric coefficient of variation (in %).~The ratio has been calculated as (nintedanib+ rifampicin) divided by nintedanib (in %)"|||53.275|47.155|1.0000
72573622|NCT01770392|144674025|SUPERIORITY_OR_OTHER||Geometric Mean Ratio in percentage|59.76|STANDARD_DEVIATION|21.9||1|TWO_SIDED|90.0|53.829|66.348||p-value for ratio outside interval 0.8 - 1.25|ANOVA|"The model includes fixed effect for treatment and effect subjects was considered as random"|"The standard deviation is actually the geometric coefficient of variation (in %).~The ratio has been calculated as (nintedanib+ rifampicin) divided by nintedanib (in %)."|||66.348|53.829|1.0000
72626868|NCT04464473|144782792|SUPERIORITY|||||||0.9504|||||||ANOVA|Interaction between visit (Baseline, MFG-cTBS, FPl-cTBS, S1-cTBS) and temporal control on error rate||||||0.9504
72409175|NCT04154631|144326818|SUPERIORITY||Coefficient of indirect effect|0.05||||0.94|TWO_SIDED|95.0|-1.16|1.25|||SEM|||Structural equation modeling (SEM) was used to test whether the relationship between treatment condition (Standard vs. Adapted) and functional impairment (Sheehan Disability Scale) at 6-month follow-up was mediated by provider ratings of acceptability (AIM) at post. The parameter of interest was the indirect effect.||1.25|-1.16|0.94
72573623|NCT01770392|144674026|SUPERIORITY_OR_OTHER||Geometric Mean Ratio in percentage|49.98|STANDARD_DEVIATION|13.3||1|TWO_SIDED|90.0|46.886|53.286||p-value for ratio outside interval 0.8 - 1.25|ANOVA|"The model includes fixed effect for treatment and effect subjects was considered as random"|"The standard deviation is actually the geometric coefficient of variation (in %).~The ratio has been calculated as (nintedanib+ rifampicin) divided by nintedanib (in %)."|||53.286|46.886|1.0000
72573624|NCT00390221|144674041|SUPERIORITY_OR_OTHER||Rate Ratio|0.461|||<|0.0001|TWO_SIDED|95.0|0.318|0.668||adjusted for the number of relapses in the 1 year prior to study entry, baseline Expanded Disability Status Scale (\<=2.5 vs \> 2.5), and age (\<=35 vs \>35)|Negative Binomial Regression|||||0.668|0.318|<0.0001
72573625|NCT00390221|144674041|SUPERIORITY_OR_OTHER||Rate Ratio|0.503||||0.0002|TWO_SIDED|95.0|0.352|0.721||adjusted for the number of relapses in the 1 year prior to study entry, baseline Expanded Disability Status Scale (\<=2.5 vs \> 2.5), and age (\<=35 vs \>35)|Negative Binomial Regression|||||0.721|0.352|0.0002
72573626|NCT00390221|144674042|SUPERIORITY_OR_OTHER||Percent Reduction|78.44|||<|0.0001|TWO_SIDED|95.0|65.97|86.35|||Negative Binomial Regression|adjusted for the baseline number of Gd-enhancing lesions||For each of the secondary endpoints, a sequential closed testing procedure was used, with the first comparison (the DAC HYP 300 mg group versus placebo) and the second comparison (the DAC HYP 150 mg group versus placebo). Secondary endpoints were rank prioritized, in the order presented. If statistical significance was not achieved for an endpoint, all endpoints(s) of a lower rank were not considered statistically significant.||86.35|65.97|<0.0001
72573627|NCT00390221|144674042|SUPERIORITY_OR_OTHER||Percent Reduction|69.47|||<|0.0001|TWO_SIDED|95.0|52.4|80.41|||Negative Binomial Regression|adjusted for the baseline number of Gd-enhancing lesions||For each of the secondary endpoints, a sequential closed testing procedure was used, with the first comparison (the DAC HYP 300 mg group versus placebo) and the second comparison (the DAC HYP 150 mg group versus placebo). Secondary endpoints were rank prioritized, in the order presented. If statistical significance was not achieved for an endpoint, all endpoints(s) of a lower rank were not considered statistically significant.||80.41|52.40|<0.0001
72573628|NCT00390221|144674043|SUPERIORITY_OR_OTHER||Percent Reduction|78.73|||<|0.0001|TWO_SIDED|95.0|71.33|84.22|||Negative Binomial Regression|adjusted for baseline number of T2 lesions||For each of the secondary endpoints, a sequential closed testing procedure was used, with the first comparison (the DAC HYP 300 mg group versus placebo) and the second comparison (the DAC HYP 150 mg group versus placebo). Secondary endpoints were rank prioritized, in the order presented. If statistical significance was not achieved for an endpoint, all endpoints(s) of a lower rank were not considered statistically significant.||84.22|71.33|<0.0001
72626869|NCT04464473|144782792|SUPERIORITY|||||||0.7318|||||||ANOVA|Interaction between visit (Baseline, MFG-cTBS, FPl-cTBS, S1-cTBS), phase (sub-task, return), and temporal control on error rate||||||0.7318
72626870|NCT04464473|144782792|SUPERIORITY|||||||0.8424|||||||ANOVA|Interaction between intervention (MFG-cTBS, FPl-cTBS, S1-cTBS) and temporal control on error rate||||||0.8424
72626871|NCT04464473|144782792|SUPERIORITY|||||||0.7652|||||||ANOVA|Interaction between intervention (MFG-cTBS, FPl-cTBS, S1-cTBS), phase (sub-task, return), and temporal control on error rate||||||0.7652
72626872|NCT04464473|144782793|SUPERIORITY|||||||0.0266|||||||ANOVA|Interaction between visit (Baseline, MFG-cTBS, FPl-cTBS, S1-cTBS) and contextual control on error rate||||||0.0266
72537464|NCT00366678|144605573|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|-2.3||||||95.0|-6.4|1.7||||||For Pertussis - FHAf the difference in percentages between the two groups (13vPnC - 7vPnC) at (≥36.00 EU/mL) threshold was calculated||1.7|-6.4|
72537465|NCT00366678|144605573|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|0.0||||||95.0|-1.4|1.4||||||For Pertussis - FHA the difference in percentages between the two groups (13vPnC - 7vPnC) at (≥7.82 EU/mL) threshold was calculated||1.4|-1.4|
72537466|NCT00366678|144605573|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|0.0||||||95.0|-1.7|2.7||||||For Pertussis - PT the difference in percentages between the two groups (13vPnC - 7vPnC) at (5 EU/mL) threshold was calculated||2.7|-1.7|
72537467|NCT00366678|144605573|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|2.1||||||95.0|-1.4|6.8||||||For Pertussis - PTf the difference in percentages between the two groups (13vPnC - 7vPnC) at (17.00 EU/mL) threshold was calculated||6.8|-1.4|
72537468|NCT00366678|144605573|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|0.0||||||95.0|-1.7|2.7||||||For Pertussis - FHA the difference in percentages between the two groups (13vPnC - 7vPnC) at (5 EU/mL) threshold was calculated||2.7|-1.7|
72537469|NCT00366678|144605573|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|0.0||||||95.0|-1.7|2.7||||||For Pertussis - FHA the difference in percentages between the two groups (13vPnC - 7vPnC) at (7.82 EU/mL) threshold was calculated||2.7|-1.7|
72537470|NCT00366678|144605573|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|-3.0||||||95.0|-8.0|2.5||||||For Pertussis - FHAf the difference in percentages between the two groups (13vPnC - 7vPnC) at (75.00 EU/mL) threshold was calculated||2.5|-8.0|
72573629|NCT00390221|144674043|SUPERIORITY_OR_OTHER||Percent Reduction|70.23|||<|0.0001|TWO_SIDED|95.0|59.94|77.88|||Negative Binomial Regression|adjusted for baseline number of T2 lesions||For each of the secondary endpoints, a sequential closed testing procedure was used, with the first comparison (the DAC HYP 300 mg group versus placebo) and the second comparison (the DAC HYP 150 mg group versus placebo). Secondary endpoints were rank prioritized, in the order presented. If statistical significance was not achieved for an endpoint, all endpoints(s) of a lower rank were not considered statistically significant.||77.88|59.94|<0.0001
72537471|NCT00366678|144605573|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|-8.0||||||95.0|-14.9|-1.2||||||For Diphtheria the difference in percentages between the two groups (13vPnC - 7vPnC) at 0.1 (IU/mL) threshold was calculated||-1.2|-14.9|
72537472|NCT00366678|144605573|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|0.0||||||95.0|-1.4|1.4||||||For Diphtheria the difference in percentages between the two groups (13vPnC - 7vPnC) at 0.01 (IU/mL) threshold was calculated||1.4|-1.4|
72537473|NCT00366678|144605573|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|2.7||||||95.0|-3.7|9.2||||||For Tetanus the difference in percentages between the two groups (13vPnC - 7vPnC) at 0.1 (IU/mL) threshold was calculated||9.2|-3.7|
72537474|NCT00366678|144605573|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|0.0||||||95.0|-1.5|1.5||||||For Tetanus the difference in percentages between the two groups (13vPnC - 7vPnC) at 0.01 (IU/mL) threshold was calculated||1.5|-1.5|
72537475|NCT00366678|144605573|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|-0.8||||||95.0|-3.1|1.8||||||For Diphtheria the difference in percentages between the two groups (13vPnC - 7vPnC) at 0.1 (IU/mL) threshold was calculated||1.8|-3.1|
72573630|NCT00390221|144674044|SUPERIORITY_OR_OTHER||Hazard Ratio|0.49||||0.0003|TWO_SIDED|95.0|0.33|0.72||Covariates included were number of relapses in the 1 year prior to study entry (p=0.001), baseline Expanded Disability Status Scale (\<=2.5 versus \>2.5, p=0.449), and age (\<=35 versus \>35, p=0.026).|Cox Proportional Hazard|||For each of the secondary endpoints, a sequential closed testing procedure was used, with the first comparison (the DAC HYP 300 mg group versus placebo) and the second comparison (the DAC HYP 150 mg group versus placebo). Secondary endpoints were rank prioritized, in the order presented. If statistical significance was not achieved for an endpoint, all endpoints(s) of a lower rank were not considered statistically significant.||0.72|0.33|0.0003
72626873|NCT04464473|144782793|SUPERIORITY|||||||0.2386|||||||ANOVA|Interaction between visit (Baseline, MFG-cTBS, FPl-cTBS, S1-cTBS), phase (sub-task, return) and contextual control on error rate||||||0.2386
72537476|NCT00366678|144605573|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|0.0||||||95.0|-1.7|2.7||||||For Diphtheria the difference in percentages between the two groups (13vPnC - 7vPnC) at 0.01 (IU/mL) threshold was calculated||2.7|-1.7|
72537477|NCT00366678|144605573|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|-2.3||||||95.0|-5.8|1.8||||||For Tetanus the difference in percentages between the two groups (13vPnC - 7vPnC) at 0.1 (IU/mL) threshold was calculated||1.8|-5.8|
72537478|NCT00366678|144605573|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|0.0||||||95.0|-1.7|2.7||||||For Tetanus the difference in percentages between the two groups (13vPnC - 7vPnC) at 0.01 (IU/mL) threshold was calculated||2.7|-1.7|
72537479|NCT00366678|144605573|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|-2.3||||||95.0|-7.6|3.0||||||For Polio Type 1 the difference in percentages between the two groups (13vPnC - 7vPnC) at (1:8) threshold was calculated||3.0|-7.6|
72537480|NCT00366678|144605573|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|-4.3||||||95.0|-11.4|2.6||||||For Polio Type 2 the difference in percentages between the two groups (13vPnC - 7vPnC) at (1:8) threshold was calculated||2.6|-11.4|
72537481|NCT00366678|144605573|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|-0.3||||||95.0|-5.0|4.3||||||For Polio Type 3 the difference in percentages between the two groups (13vPnC - 7vPnC) at (1:8) threshold was calculated||4.3|-5.0|
72537482|NCT00366678|144605573|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|-0.5||||||95.0|-3.6|3.5||||||For Polio Type 1 the difference in percentages between the two groups (13vPnC - 7vPnC) at (1:8) threshold was calculated||3.5|-3.6|
72537483|NCT00366678|144605573|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|-0.5||||||95.0|-3.1|3.0||||||For Polio Type 2 the difference in percentages between the two groups (13vPnC - 7vPnC) at (1:8) threshold was calculated||3.0|-3.1|
72573631|NCT00390221|144674044|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.45|||<|0.0001|TWO_SIDED|95.0|0.3|0.67||Covariates included were number of relapses in the 1 year prior to study entry (p=0.001), baseline Expanded Disability Status Scale (\<=2.5 versus \>2.5, p=0.449), and age (\<=35 versus \>35, p=0.026).|Cox Proportional Hazard|||For each of the secondary endpoints, a sequential closed testing procedure was used, with the first comparison (the DAC HYP 300 mg group versus placebo) and the second comparison (the DAC HYP 150 mg group versus placebo). Secondary endpoints were rank prioritized, in the order presented. If statistical significance was not achieved for an endpoint, all endpoints(s) of a lower rank were not considered statistically significant.||0.67|0.30|<0.0001
72537484|NCT00366678|144605573|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|-0.8||||||95.0|-3.1|1.9||||||For Polio Type 3 the difference in percentages between the two groups (13vPnC - 7vPnC) at (1:8) threshold was calculated||1.9|-3.1|
72537485|NCT00366678|144605573|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|0.9||||||95.0|-3.2|5.0||||||For Hib (PRP) the difference in percentages between the two groups (13vPnC - 7vPnC) at 0.15 (μg/mL) threshold was calculated||5.0|-3.2|
72537486|NCT00366678|144605573|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|-4.5||||||95.0|-13.2|4.4||||||For Hib (PRP) the difference in percentages between the two groups (13vPnC - 7vPnC) at 1.0 (μg/mL) threshold was calculated||4.4|-13.2|
72537487|NCT00366678|144605573|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|0.0||||||95.0|-1.7|2.8||||||For Hib (PRP) the difference in percentages between the two groups (13vPnC - 7vPnC) at 0.15 (μg/mL) threshold was calculated||2.8|-1.7|
72537488|NCT00366678|144605573|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|0.2||||||95.0|-3.1|4.5||||||For Hib (PRP) the difference in percentages between the two groups (13vPnC - 7vPnC) at 1.0 (μg/mL) threshold was calculated||4.5|-3.1|
72537489|NCT00366678|144605574|SUPERIORITY_OR_OTHER||Difference|0.0||||||95.0|-1.7|2.9||||||For serotype 4 the difference in percentages between the two groups (13vPnC Infant Series / 13vPnC Toddler Dose - 7vPnC Infant Series / 7vPnC Toddler Dose) was calculated||2.9|-1.7|
72537490|NCT00366678|144605574|SUPERIORITY_OR_OTHER||Difference|0.9||||||95.0|-0.9|4.9||||||For serotype 4 the difference in percentages between the two groups (13vPnC Infant Series / 13vPnC Toddler Dose - 7vPnC Infant Series / 13vPnC Toddler Dose) was calculated||4.9|-0.9|
72537491|NCT00366678|144605574|SUPERIORITY_OR_OTHER||Difference|-0.9||||||95.0|-4.9|2.1||||||For serotype 4 the difference in percentages between the two groups (7vPnC Infant Series / 13vPnC Toddler Dose - 7vPnC Infant Series / 7vPnC Toddler Dose) was calculated||2.1|-4.9|
72537492|NCT00366678|144605574|SUPERIORITY_OR_OTHER||Difference|0.4||||||95.0|-1.8|3.8||||||For serotype 6B the difference in percentages between the two groups (13vPnC Infant Series / 13vPnC Toddler Dose - 7vPnC Infant Series / 7vPnC Toddler Dose) was calculated||3.8|-1.8|
72537493|NCT00366678|144605574|SUPERIORITY_OR_OTHER||Difference|1.4||||||95.0|-1.1|5.9||||||For serotype 6B the difference in percentages between the two groups (13vPnC Infant Series / 13vPnC Toddler Dose - 7vPnC Infant Series / 13vPnC Toddler Dose) was calculated||5.9|-1.1|
72537494|NCT00366678|144605574|SUPERIORITY_OR_OTHER||Difference|-1.1||||||95.0|-5.8|2.7||||||For serotype 6B the difference in percentages between the two groups (7vPnC Infant Series / 13vPnC Toddler Dose - 7vPnC Infant Series / 7vPnC Toddler Dose) was calculated||2.7|-5.8|
72537495|NCT00366678|144605574|SUPERIORITY_OR_OTHER||Difference|0.0||||||95.0|-1.7|2.9||||||For serotype 9V the difference in percentages between the two groups (13vPnC Infant Series / 13vPnC Toddler Dose - 7vPnC Infant Series / 7vPnC Toddler Dose) was calculated||2.9|-1.7|
72537496|NCT00366678|144605574|SUPERIORITY_OR_OTHER||Difference|0.0||||||95.0|-1.8|3.3||||||For serotype 9V the difference in percentages between the two groups (13vPnC Infant Series / 13vPnC Toddler Dose - 7vPnC Infant Series / 13vPnC Toddler Dose) was calculated||3.3|-1.8|
72537497|NCT00366678|144605574|SUPERIORITY_OR_OTHER||Difference|0.0||||||95.0|-3.3|3.0||||||For serotype 9V the difference in percentages between the two groups (7vPnC Infant Series / 13vPnC Toddler Dose - 7vPnC Infant Series / 7vPnC Toddler Dose) was calculated||3.0|-3.3|
72537498|NCT00366678|144605574|SUPERIORITY_OR_OTHER||Difference|-0.4||||||95.0|-2.5|2.4||||||For serotype 14 the difference in percentages between the two groups (13vPnC Infant Series / 13vPnC Toddler Dose - 7vPnC Infant Series / 7vPnC Toddler Dose) was calculated||2.4|-2.5|
72369078|NCT01262989|144248169|NON_INFERIORITY_OR_EQUIVALENCE|This is a bioequivalence study performed to support the register of tamsulosin hydrochloride, produced by Synthon BV, as a branded generic, to be marketed by GlaxoSmithKline Brasil Ltda., according to the requirements of the Brazilian Regulatory Agency - National Agency of Sanitary Surveillance (ANVISA).|Ratio T formulation/R formulation|102.95||||||90.0|97.17|109.07|||||The ratios between the geometric means of the test (T) and reference (R) formulations was calculated.|||109.07|97.17|
72573632|NCT00390221|144674045|SUPERIORITY_OR_OTHER||Relative Mean Change|-1.93||||0.1284|TWO_SIDED|95.0|-4.42|0.56||Analysis of variance for difference between treatment groups, controlling for baseline score.|Analysis of Variance|||For each of the secondary endpoints, a sequential closed testing procedure was used, with the first comparison (the DAC HYP 300 mg group versus placebo) and the second comparison (the DAC HYP 150 mg group versus placebo). Secondary endpoints were rank prioritized, in the order presented. If statistical significance was not achieved for an endpoint, all endpoints(s) of a lower rank were not considered statistically significant.||0.56|-4.42|0.1284
72573633|NCT00390221|144674045|SUPERIORITY_OR_OTHER||Relative Mean Change|-4.27||||0.0008|TWO_SIDED|95.0|-6.76|-1.78|||Analysis of Variance|Analysis of variance for difference between treatment groups, controlling for baseline score.||For each of the secondary endpoints, a sequential closed testing procedure was used, with the first comparison (the DAC HYP 300 mg group versus placebo) and the second comparison (the DAC HYP 150 mg group versus placebo). Secondary endpoints were rank prioritized, in the order presented. If statistical significance was not achieved for an endpoint, all endpoints(s) of a lower rank were not considered statistically significant.||-1.78|-6.76|0.0008
72573634|NCT03258853|144674106|SUPERIORITY|||||||0.001|||||||paired 2-sided t-test|||||||0.001
72573635|NCT03258853|144674107|SUPERIORITY|||||||1||||||Secondary outcomes were adjusted for multiple comparisons|Wilcoxon signed rank test|||||||1.0
72573636|NCT03258853|144674108|SUPERIORITY|||||||0.04||||||Secondary outcomes are adjusted for multiple comparisons|paired 2-sided t-test|||||||0.04
72573637|NCT03258853|144674109|SUPERIORITY|||||||1||||||Adjusted for multiple comparisons|Wicoxon signed rank test|||||||1.0
72573638|NCT03258853|144674110|SUPERIORITY|||||||0.014||||||Adjusted for multiple comparisons|Wilcoxon signed rank test|||||||0.014
72573639|NCT03258853|144674111|SUPERIORITY|||||||0.014||||||Adjusted for multiple comparisons|Wilcoxon signed rank test|||||||0.014
72573640|NCT03258853|144674112|SUPERIORITY|||||||0.14||||||Adjusted for multiple comparisons|Wilcoxon signed rank test|||||||0.14
72573641|NCT03258853|144674113|SUPERIORITY|||||||1||||||Adjusted for multiple comparisons|Wilcoxon signed rank test|||||||1.0
72573642|NCT03258853|144674114|SUPERIORITY|||||||0.01|||||||Wilcoxon signed rank test|||||||0.01
72573643|NCT03258853|144674115|SUPERIORITY|||||||0.08|||||||McNemar|||||||0.08
72573644|NCT03258853|144674116|SUPERIORITY|||||||0.56|||||||McNemar|||||||0.56
72573645|NCT03258853|144674117|SUPERIORITY|||||||0.56|||||||McNemar|||||||0.56
72573646|NCT03258853|144674118|SUPERIORITY|||||||0.15|||||||McNemar|||||||0.15
72573647|NCT02081209|144674150|OTHER||sucess percentage|82.4|||||TWO_SIDED|95.0|76.4|87.3||||||||87.3|76.4|
72573648|NCT02081209|144674150|OTHER||sucess percentage|77.4|||||TWO_SIDED|95.0|68.1|85.1||||||||85.1|68.1|
72573649|NCT02081209|144674150|OTHER||sucess percentage|79.2|||||TWO_SIDED|95.0|65.0|89.5||||||||89.5|65.0|
72573650|NCT02081209|144674150|OTHER||sucess percentage|94.0|||||TWO_SIDED|95.0|84.6|98.8||||||||98.8|84.6|
72573651|NCT02081209|144674151|OTHER||Mean Difference (Net)|2.3|STANDARD_DEVIATION|1.9|<|0.001|TWO_SIDED||||||t-test, 2 sided|||||||<0.001
72573652|NCT02081209|144674151|OTHER||Mean Difference (Net)|1.3|||||TWO_SIDED|95.0|0.5|2.1||||||||2.1|0.5|
72573653|NCT02081209|144674151|OTHER||Mean Difference (Net)|3.0|||||TWO_SIDED|95.0|2.0|4.1||||||||4.1|2.0|
72573654|NCT02081209|144674152|OTHER||||||||||||||||||Data from the 16-week follow-up questionnaire were tabulated for all subjects with completed questionnaires.. All confidence intervals were calculated at 95%. Alpha was calculated to be 0.05, critical probability (p\*) was calculated to be 0.975. Assuming normal distribution of survey recipients, a standard deviation of 1.96 is used to calculate the standard margin of error.|||
72573655|NCT06378749|144674153|OTHER|||||||0.029|||||||t-test, 2 sided|||||||.029
72573656|NCT06378749|144674154|OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
72409176|NCT04154631|144326818|SUPERIORITY||Coefficient of indirect effect|0.03||||0.85|TWO_SIDED|95.0|-0.3|0.37|||SEM|||Structural equation modeling (SEM) was used to test whether the relationship between treatment condition (Standard vs. Adapted) and functional impairment (Sheehan Disability Scale) at post was mediated by provider ratings of appropriateness (IAM) at post. The parameter of interest was the indirect effect.||0.37|-0.30|0.85
72573657|NCT06378749|144674155|OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
72573658|NCT06378749|144674156|OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
72573659|NCT06378749|144674157|OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
72573660|NCT05538065|144674158|SUPERIORITY||Risk Ratio (RR)|1.4||||0.002|TWO_SIDED|95.0|1.1|1.78||Adjusted for multiple comparisons|Regression, Logistic|||Outcomes were evaluated using generalized estimating equations with a log link and binary errors, adjusting for provider-level clustering and Holm-Bonferroni multiple comparisons.||1.78|1.10|0.002
72573661|NCT05538065|144674158|SUPERIORITY||Risk Ratio (RR)|1.26||||0.039|TWO_SIDED|95.0|1.01|1.57||Adjusted for multiple comparisons|Regression, Logistic|||Outcomes were evaluated using generalized estimating equations with a log link and binary errors, adjusting for provider-level clustering and Holm-Bonferroni multiple comparisons.||1.57|1.01|0.039
72573662|NCT05538065|144674159|SUPERIORITY||Mean Difference (Final Values)|29.0||||0.386|TWO_SIDED|95.0|-36.6|94.6||Adjusted for multiple testing|Regression, Linear|||Outcomes were evaluated using generalized estimating equations with an identity link and normally-distributed errors, adjusting for provider-level clustering and Holm-Bonferroni multiple comparisons.||94.6|-36.6|0.386
72573663|NCT05538065|144674159|SUPERIORITY||Mean Difference (Final Values)|38.1||||272|TWO_SIDED|95.0|-29.9|106.1||Adjusted for multiple comparisons|Regression, Linear|||Outcomes were evaluated using generalized estimating equations with an identity link and normally-distributed errors, adjusting for provider-level clustering and Holm-Bonferroni multiple comparisons.||106.1|-29.9|272
72573664|NCT05538065|144674160|SUPERIORITY||Mean Difference (Final Values)|-13.8||||0.657|TWO_SIDED|95.0|-74.5|47.0||Adjusted for multiple testing|Regression, Linear|||Outcomes were evaluated using generalized estimating equations with an identity link and normally-distributed errors, adjusting for provider-level clustering and Holm-Bonferroni multiple comparisons.||47.0|-74.5|0.657
72537499|NCT00366678|144605574|SUPERIORITY_OR_OTHER||Difference|0.5||||||95.0|-1.8|4.4||||||For serotype 14 the difference in percentages between the two groups (13vPnC Infant Series / 13vPnC Toddler Dose - 7vPnC Infant Series / 13vPnC Toddler Dose) was calculated||4.4|-1.8|
72537500|NCT00366678|144605574|SUPERIORITY_OR_OTHER||Difference|-0.9||||||95.0|-4.9|2.1||||||For serotype 14 the difference in percentages between the two groups (7vPnC Infant Series / 13vPnC Toddler Dose - 7vPnC Infant Series / 7vPnC Toddler Dose) was calculated||2.1|-4.9|
72537501|NCT00366678|144605574|SUPERIORITY_OR_OTHER||Difference|0.4||||||95.0|-1.8|3.8||||||For serotype 18C the difference in percentages between the two groups (13vPnC Infant Series / 13vPnC Toddler Dose - 7vPnC Infant Series / 7vPnC Toddler Dose) was calculated||3.8|-1.8|
72537502|NCT00366678|144605574|SUPERIORITY_OR_OTHER||Difference|1.3||||||95.0|-1.1|5.7||||||For serotype 18C the difference in percentages between the two groups (13vPnC Infant Series / 13vPnC Toddler Dose - 7vPnC Infant Series / 13vPnC Toddler Dose) was calculated||5.7|-1.1|
72537503|NCT00366678|144605574|SUPERIORITY_OR_OTHER||Difference|-1.0||||||95.0|-5.5|2.8||||||For serotype 18C the difference in percentages between the two groups (7vPnC Infant Series / 13vPnC Toddler Dose - 7vPnC Infant Series / 7vPnC Toddler Dose) was calculated||2.8|-5.5|
72537504|NCT00366678|144605574|SUPERIORITY_OR_OTHER||Difference|0.2||||||95.0|-3.1|4.7||||||For serotype 19F the difference in percentages between the two groups (13vPnC Infant Series / 13vPnC Toddler Dose - 7vPnC Infant Series / 7vPnC Toddler Dose) was calculated||4.7|-3.1|
72537505|NCT00366678|144605574|SUPERIORITY_OR_OTHER||Difference|0.5||||||95.0|-2.9|5.4||||||For serotype 19F the difference in percentages between the two groups (13vPnC Infant Series / 13vPnC Toddler Dose - 7vPnC Infant Series / 13vPnC Toddler Dose) was calculated||5.4|-2.9|
72537506|NCT00366678|144605574|SUPERIORITY_OR_OTHER||Difference|-0.3||||||95.0|-5.5|4.4||||||For serotype 19F the difference in percentages between the two groups (7vPnC Infant Series / 13vPnC Toddler Dose - 7vPnC Infant Series / 7vPnC Toddler Dose) was calculated||4.4|-5.5|
72537507|NCT00366678|144605574|SUPERIORITY_OR_OTHER||Difference|0.4||||||95.0|-1.8|3.9||||||For serotype 23F the difference in percentages between the two groups (13vPnC Infant Series / 13vPnC Toddler Dose - 7vPnC Infant Series / 7vPnC Toddler Dose) was calculated||3.9|-1.8|
72537508|NCT00366678|144605574|SUPERIORITY_OR_OTHER||Difference|0.5||||||95.0|-1.9|4.4||||||For serotype 23F the difference in percentages between the two groups (13vPnC Infant Series / 13vPnC Toddler Dose - 7vPnC Infant Series / 13vPnC Toddler Dose) was calculated||4.4|-1.9|
72537509|NCT00366678|144605574|SUPERIORITY_OR_OTHER||Difference|-0.1||||||95.0|-4.1|3.7||||||For serotype 23F the difference in percentages between the two groups (7vPnC Infant Series / 13vPnC Toddler Dose - 7vPnC Infant Series / 7vPnC Toddler Dose) was calculated||3.7|-4.1|
72537510|NCT00366678|144605575|SUPERIORITY_OR_OTHER||Ratio|0.87||||||95.0|0.73|1.03||||||For serotype 4 after the toddler dose the GMC ratio (13vPnC Infant Series/13vPnC Toddler Dose After Toddler Dose / 7vPnC Infant Series/7vPnC Toddler Dose After Toddler Dose) was calculated||1.03|0.73|
72537511|NCT00366678|144605575|SUPERIORITY_OR_OTHER||Ratio|0.83||||||95.0|0.67|1.03||||||For serotype 4 after the toddler dose the GMC ratio (7vPnC Infant Series/13vPnC Toddler Dose After Toddler Dose / 7vPnC Infant Series/7vPnC Toddler Dose After Toddler Dose) was calculated||1.03|0.67|
72537512|NCT00366678|144605575|SUPERIORITY_OR_OTHER||Ratio|1.04||||||95.0|0.86|1.26||||||For serotype 4 after the toddler dose the GMC ratio (13vPnC Infant Series/13vPnC Toddler Dose After Toddler Dose / 7vPnC Infant Series/13vPnC Toddler Dose After Toddler Dose) was calculated||1.26|0.86|
72537513|NCT00366678|144605575|SUPERIORITY_OR_OTHER||Ratio|0.93||||||95.0|0.77|1.13||||||For serotype 6B after the toddler dose the GMC ratio (13vPnC Infant Series/13vPnC Toddler Dose After Toddler Dose / 7vPnC Infant Series/7vPnC Toddler Dose After Toddler Dose) was calculated||1.13|0.77|
72537514|NCT00366678|144605575|SUPERIORITY_OR_OTHER||Ratio|1.07||||||95.0|0.82|1.4||||||For serotype 6B after the toddler dose the GMC ratio (7vPnC Infant Series/13vPnC Toddler Dose After Toddler Dose / 7vPnC Infant Series/7vPnC Toddler Dose After Toddler Dose) was calculated||1.40|0.82|
72537515|NCT00366678|144605575|SUPERIORITY_OR_OTHER||Ratio|0.87||||||95.0|0.69|1.1||||||For serotype 6B after the toddler dose the GMC ratio (13vPnC Infant Series/13vPnC Toddler Dose After Toddler Dose / 7vPnC Infant Series/13vPnC Toddler Dose After Toddler Dose) was calculated||1.10|0.69|
72537516|NCT00366678|144605575|SUPERIORITY_OR_OTHER||Ratio|0.8||||||95.0|0.68|0.94||||||For serotype 9V after the toddler dose the GMC ratio (13vPnC Infant Series/13vPnC Toddler Dose After Toddler Dose / 7vPnC Infant Series/7vPnC Toddler Dose After Toddler Dose) was calculated||0.94|0.68|
72537517|NCT00366678|144605575|SUPERIORITY_OR_OTHER||Ratio|0.71||||||95.0|0.59|0.85||||||For serotype 9V after the toddler dose the GMC ratio (7vPnC Infant Series/13vPnC Toddler Dose After Toddler Dose / 7vPnC Infant Series/7vPnC Toddler Dose After Toddler Dose) was calculated||0.85|0.59|
72537518|NCT00366678|144605575|SUPERIORITY_OR_OTHER||Ratio|1.13||||||95.0|0.95|1.33||||||For serotype 9V after the toddler dose the GMC ratio (13vPnC Infant Series/13vPnC Toddler Dose After Toddler Dose / 7vPnC Infant Series/13vPnC Toddler Dose After Toddler Dose) was calculated||1.33|0.95|
72537519|NCT00366678|144605575|SUPERIORITY_OR_OTHER||Ratio|0.88||||||95.0|0.73|1.06||||||For serotype 14 after the toddler dose the GMC ratio (13vPnC Infant Series/13vPnC Toddler Dose After Toddler Dose / 7vPnC Infant Series/7vPnC Toddler Dose After Toddler Dose) was calculated||1.06|0.73|
72537520|NCT00366678|144605575|SUPERIORITY_OR_OTHER||Ratio|0.72||||||95.0|0.58|0.9||||||For serotype 14 after the toddler dose the GMC ratio (7vPnC Infant Series/13vPnC Toddler Dose After Toddler Dose / 7vPnC Infant Series/7vPnC Toddler Dose After Toddler Dose) was calculated||0.90|0.58|
72537521|NCT00366678|144605575|SUPERIORITY_OR_OTHER||Ratio|1.22||||||95.0|1.0|1.49||||||For serotype 14 after the toddler dose the GMC ratio (13vPnC Infant Series/13vPnC Toddler Dose After Toddler Dose / 7vPnC Infant Series/13vPnC Toddler Dose After Toddler Dose) was calculated||1.49|1.00|
72537522|NCT00366678|144605575|SUPERIORITY_OR_OTHER||Ratio|0.82||||||95.0|0.69|0.97||||||For serotype 18C after the toddler dose the GMC ratio (13vPnC Infant Series/13vPnC Toddler Dose After Toddler Dose / 7vPnC Infant Series/7vPnC Toddler Dose After Toddler Dose) was calculated||0.97|0.69|
72537523|NCT00366678|144605575|SUPERIORITY_OR_OTHER||Ratio|0.86||||||95.0|0.69|1.08||||||For serotype 18C after the toddler dose the GMC ratio (7vPnC Infant Series/13vPnC Toddler Dose After Toddler Dose / 7vPnC Infant Series/7vPnC Toddler Dose After Toddler Dose) was calculated||1.08|0.69|
72537524|NCT00366678|144605575|SUPERIORITY_OR_OTHER||Ratio|0.95||||||95.0|0.78|1.15||||||For serotype 18C after the toddler dose the GMC ratio (13vPnC Infant Series/13vPnC Toddler Dose After Toddler Dose / 7vPnC Infant Series/13vPnC Toddler Dose After Toddler Dose) was calculated||1.15|0.78|
72573665|NCT05538065|144674160|SUPERIORITY||Mean Difference (Final Values)|15.1||||0.696|TWO_SIDED|95.0|-60.7|91.0|||Regression, Linear|Adjusted for multiple testing||Outcomes were evaluated using generalized estimating equations with an identity link and normally-distributed errors, adjusting for provider-level clustering and Holm-Bonferroni multiple comparisons.||91.0|-60.7|0.696
72626874|NCT04464473|144782793|SUPERIORITY|||||||0.4211|||||||ANOVA|Interaction between intervention (MFG-cTBS, FPl-cTBS, S1-cTBS) and contextual control on error rate||||||0.4211
72409177|NCT04154631|144326818|SUPERIORITY||Coefficient of indirect effect|-0.23||||0.7|TWO_SIDED|95.0|-1.41|0.95|||SEM|||Structural equation modeling (SEM) was used to test whether the relationship between treatment condition (Standard vs. Adapted) and functional impairment (Sheehan Disability Scale) at 6-month follow-up was mediated by provider ratings of appropriateness (IAM) at post. The parameter of interest was the indirect effect.||0.95|-1.41|0.70
72537525|NCT00366678|144605575|SUPERIORITY_OR_OTHER||Ratio|1.26||||||95.0|1.0|1.59||||||For serotype 19F after the toddler dose the GMC ratio (13vPnC Infant Series/13vPnC Toddler Dose After Toddler Dose / 7vPnC Infant Series/7vPnC Toddler Dose After Toddler Dose) was calculated||1.59|1.00|
72537526|NCT00366678|144605575|SUPERIORITY_OR_OTHER||Ratio|0.91||||||95.0|0.68|1.2||||||For serotype 19F after the toddler dose the GMC ratio (7vPnC Infant Series/13vPnC Toddler Dose After Toddler Dose / 7vPnC Infant Series/7vPnC Toddler Dose After Toddler Dose) was calculated||1.20|0.68|
72537527|NCT00366678|144605575|SUPERIORITY_OR_OTHER||Ratio|1.39||||||95.0|1.08|1.79||||||For serotype 19F after the toddler dose the GMC ratio (13vPnC Infant Series/13vPnC Toddler Dose After Toddler Dose / 7vPnC Infant Series/13vPnC Toddler Dose After Toddler Dose) was calculated||1.79|1.08|
72537528|NCT00366678|144605575|SUPERIORITY_OR_OTHER||Ratio|0.81||||||95.0|0.67|1.0||||||For serotype 23F after the toddler dose the GMC ratio (13vPnC Infant Series/13vPnC Toddler Dose After Toddler Dose / 7vPnC Infant Series/7vPnC Toddler Dose After Toddler Dose) was calculated||1.00|0.67|
72537529|NCT00366678|144605575|SUPERIORITY_OR_OTHER||Ratio|0.85||||||95.0|0.67|1.07||||||For serotype 23F after the toddler dose the GMC ratio (7vPnC Infant Series/13vPnC Toddler Dose After Toddler Dose / 7vPnC Infant Series/7vPnC Toddler Dose After Toddler Dose) was calculated||1.07|0.67|
72537530|NCT00366678|144605575|SUPERIORITY_OR_OTHER||Ratio|0.96||||||95.0|0.78|1.19||||||For serotype 23F after the toddler dose the GMC ratio (13vPnC Infant Series/13vPnC Toddler Dose After Toddler Dose / 7vPnC Infant Series/13vPnC Toddler Dose After Toddler Dose) was calculated||1.19|0.78|
72537531|NCT00366678|144605578|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|0.77||||||95.0|0.66|0.9||||||For Diphtheria the GMC ratio was calculated||0.90|0.66|
72537532|NCT00366678|144605578|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|0.94||||||95.0|0.82|1.08||||||For Tetanus the GMC ratio was calculated||1.08|0.82|
72537533|NCT00366678|144605578|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|0.8||||||95.0|0.67|0.97||||||For Diphtheria the GMC ratio was calculated||0.97|0.67|
72537534|NCT00366678|144605578|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|0.86||||||95.0|0.69|1.08||||||For Tetanus the GMC ratio was calculated||1.08|0.69|
72537535|NCT00366678|144605579|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|0.91||||||95.0|0.73|1.14||||||For Hib (PRP) the GMC ratio was calculated||1.14|0.73|
72537536|NCT00366678|144605579|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|1.04||||||95.0|0.82|1.32||||||For Hib (PRP) the GMC ratio was calculated||1.32|0.82|
72537537|NCT00366678|144605580|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|0.88||||||95.0|0.71|1.09||||||For Polio Type 1 the GMC ratio was calculated||1.09|0.71|
72537538|NCT00366678|144605580|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|0.82||||||95.0|0.66|1.03||||||For Polio Type 2 the GMC ratio was calculated||1.03|0.66|
72537539|NCT00366678|144605580|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|0.78||||||95.0|0.59|1.02||||||For Polio Type 3 the GMC ratio was calculated||1.02|0.59|
72537540|NCT00366678|144605580|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|1.01||||||95.0|0.72|1.41||||||For Polio Type 1 the GMC ratio was calculated||1.41|0.72|
72537541|NCT00366678|144605580|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|0.98||||||95.0|0.72|1.34||||||For Polio Type 2 the GMC ratio was calculated||1.34|0.72|
72573666|NCT00191113|144674167|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.9|||<|0.001||95.0|0.7|1.1|||ANCOVA|Model includes baseline height SDS, baseline age, treatment, and interactions. Age and interaction terms removed when not significant.|"Effect direction is As-Randomized Humatrope minus As-Randomized Control"|This component of the primary analysis is inferential i.e. to ascertain definitively whether Humatrope treatment affects change in Height SDS (NCHS). Null hypothesis is no effect of Humatrope treatment.||1.1|0.7|<0.001
72626875|NCT04464473|144782793|SUPERIORITY|||||||0.7503|||||||ANOVA|Interaction between intervention (MFG-cTBS, FPl-cTBS, S1-cTBS), phase (sub-task, return) and contextual control on error rate||||||0.7503
72626876|NCT04464473|144782794|SUPERIORITY|||||||0.0091|||||||ANOVA|Interaction of Visit (Baseline, MFG-cTBS, FPl-cTBS, S1), Temporal Control, and Contextual Control on error rate||||||0.0091
72626877|NCT04464473|144782794|SUPERIORITY|||||||0.0045|||||||ANOVA|Interaction of Visit (Baseline, MFG-cTBS, FPl-cTBS, S1), phase (sub-task, return), Temporal Control, and Contextual Control on error rate||||||0.0045
72409178|NCT04154631|144326818|SUPERIORITY||Coefficient of indirect effect|0.01||||0.92|TWO_SIDED|95.0|-0.23|0.25|||SEM|||Structural equation modeling (SEM) was used to test whether the relationship between treatment condition (Standard vs. Adapted) and functional impairment (Sheehan Disability Scale) at post was mediated by provider ratings of feasibility (FIM) at post. The parameter of interest was the indirect effect.||0.25|-0.23|0.92
72537542|NCT00366678|144605580|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|0.84||||||95.0|0.6|1.17||||||For Polio Type 3 the GMC ratio was calculated||1.17|0.60|
72537543|NCT00366678|144605581|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|0.87||||||95.0|0.78|0.98||||||For Pertussis - FHA the GMC ratio was calculated||0.98|0.78|
72537544|NCT00366678|144605581|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|0.92||||||95.0|0.84|1.02||||||For Pertussis - PT the GMC ratio was calculated||1.02|0.84|
72537545|NCT00366678|144605581|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|0.85||||||95.0|0.72|1.0||||||For Pertussis - FHA the GMC ratio was calculated||1.00|0.72|
72537546|NCT00366678|144605581|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|0.99||||||95.0|0.86|1.14||||||For Pertussis - PT the GMC ratio was calculated||1.14|0.86|
72537547|NCT02545868|144605591|SUPERIORITY||normal distribution approximation|-30.7|||||TWO_SIDED|95.0|-50.5|-10.8||||||Difference in positive response, Group A minus Group B||-10.8|-50.5|
72537548|NCT02545868|144605592|SUPERIORITY||normal distribution approximation|-36.4|||||TWO_SIDED|95.0|-56.0|-16.7||||||Difference in positive response, Group A minus Group B||-16.7|-56.0|
72537549|NCT02545868|144605593|SUPERIORITY||normal distribution approximation|-47.0|||||TWO_SIDED|95.0|-63.2|-30.7||||||Difference in positive response, Group A minus Group B||-30.7|-63.2|
72537550|NCT02545868|144605597|SUPERIORITY||Normal Distribution Approximation|-50.7|||||TWO_SIDED|95.0|-62.7|-38.8||||||Serotype 1||-38.8|-62.7|
72537551|NCT02545868|144605597|SUPERIORITY||Normal Distribution Approximation|-43.3|||||TWO_SIDED|95.0|-56.5|-30.1||||||Serotype 2||-30.1|-56.5|
72409179|NCT04154631|144326818|SUPERIORITY||Coefficient of indirect effect|-0.07||||0.82|TWO_SIDED|95.0|-0.68|0.54|||SEM|||Structural equation modeling (SEM) was used to test whether the relationship between treatment condition (Standard vs. Adapted) and functional impairment (Sheehan Disability Scale) at 6-month follow-up was mediated by provider ratings of feasibility (FIM) at post. The parameter of interest was the indirect effect.||0.54|-0.68|0.82
72537552|NCT02545868|144605597|SUPERIORITY||Normal Distribution Approximation|-48.0|||||TWO_SIDED|95.0|-65.2|-30.9||||||Serotype 3||-30.9|-65.2|
72537553|NCT02545868|144605597|SUPERIORITY||Normal Distribution Approximation|-62.8|||||TWO_SIDED|95.0|-77.2|-48.4||||||Serotype 4||-48.4|-77.2|
72537554|NCT02545868|144605597|SUPERIORITY||Normal Distribution Approximation|-53.8|||||TWO_SIDED|95.0|-68.0|-39.7||||||Serotype 5||-39.7|-68.0|
72537555|NCT02545868|144605597|SUPERIORITY||Normal Distribution Approximation|-37.5|||||TWO_SIDED|95.0|-54.4|-20.7||||||Serotype 6B||-20.7|-54.4|
72537556|NCT02545868|144605597|SUPERIORITY||Normal Distribution Approximation|-58.3|||||TWO_SIDED|95.0|-73.1|-43.6||||||Serotype 7F||-43.6|-73.1|
72537557|NCT02545868|144605597|SUPERIORITY||Normal Distribution Approximation|-32.9|||||TWO_SIDED|95.0|-45.7|-20.1||||||Serotype 8||-20.1|-45.7|
72537558|NCT02545868|144605597|SUPERIORITY||Normal Distribution Approximation|-46.4|||||TWO_SIDED|95.0|-62.5|-30.4||||||Serotype 9N||-30.4|-62.5|
72537559|NCT02545868|144605597|SUPERIORITY||Normal Distribution Approximation|-40.4|||||TWO_SIDED|95.0|-55.7|-25.1||||||Serotype 9V||-25.1|-55.7|
72537560|NCT02545868|144605597|SUPERIORITY||Normal Distribution Approximation|-62.8|||||TWO_SIDED|95.0|-77.2|-48.4||||||Serotype 10A||-48.4|-77.2|
72537561|NCT02545868|144605597|SUPERIORITY||Normal Distribution Approximation|-52.5|||||TWO_SIDED|95.0|-69.4|-35.6||||||Serotype 11A||-35.6|-69.4|
72537562|NCT02545868|144605597|SUPERIORITY||Normal Distribution Approximation|-55.6|||||TWO_SIDED|95.0|-72.8|-38.3||||||Serotype 12F||-38.3|-72.8|
72537563|NCT02545868|144605597|SUPERIORITY||Normal Distribution Approximation|-25.5|||||TWO_SIDED|95.0|-41.4|-9.7||||||Serotype 14||-9.7|-41.4|
72537564|NCT02545868|144605597|SUPERIORITY||Normal Distribution Approximation|-47.9|||||TWO_SIDED|95.0|-63.9|-32.0||||||Serotype 15B||-32.0|-63.9|
72537565|NCT02545868|144605597|SUPERIORITY||Normal Distribution Approximation|-56.9|||||TWO_SIDED|95.0|-72.4|-41.4||||||Serotype 17F||-41.4|-72.4|
72537566|NCT02545868|144605597|SUPERIORITY||Normal Distribution Approximation|-52.4|||||TWO_SIDED|95.0|-67.4|-37.3||||||Serotype 18C||-37.3|-67.4|
72537567|NCT02545868|144605597|SUPERIORITY||Normal Distribution Approximation|-46.4|||||TWO_SIDED|95.0|-62.5|-30.4||||||Serotype 19A||-30.4|-62.5|
72537568|NCT02545868|144605597|SUPERIORITY||Normal Distribution Approximation|-52.5|||||TWO_SIDED|95.0|-68.8|-36.1||||||Serotype 19F||-36.1|-68.8|
72537569|NCT02545868|144605597|SUPERIORITY||Normal Distribution Approximation|-61.5|||||TWO_SIDED|95.0|-77.5|-45.4||||||Serotype 20||-45.4|-77.5|
72537570|NCT02545868|144605597|SUPERIORITY||Normal Distribution Approximation|-56.8|||||TWO_SIDED|95.0|-71.7|-42.0||||||Serotype 22F||-42.0|-71.7|
72537571|NCT02545868|144605597|SUPERIORITY||Normal Distribution Approximation|-33.2|||||TWO_SIDED|95.0|-51.7|-14.6||||||Serotype 23F||-14.6|-51.7|
72537572|NCT02545868|144605597|SUPERIORITY||Normal Distribution Approximation|-47.8|||||TWO_SIDED|95.0|-62.2|-33.5||||||Serotype 33F||-33.5|-62.2|
72537573|NCT02545868|144605598|SUPERIORITY||Normal Distribution Approximation|-13.4|||||TWO_SIDED|95.0|-21.6|-5.3||||||||-5.3|-21.6|
72537574|NCT02545868|144605599|SUPERIORITY||Normal Distribution Approximation|-59.7|||||TWO_SIDED|95.0|-72.6|-46.8||||||||-46.8|-72.6|
72537575|NCT02545868|144605601|SUPERIORITY||Normal Distribution Approximation|-45.2|||||TWO_SIDED|95.0|-62.7|-27.6||||||Serotype 1- Difference in positive response, Group A1 minus Group B||-27.6|-62.7|
72537576|NCT02545868|144605601|SUPERIORITY||Normal Distribution Approximation|-42.2|||||TWO_SIDED|95.0|-60.6|-23.8||||||Serotype 2- Difference in positive response, Group A1 minus Group B||-23.8|-60.6|
72537577|NCT02545868|144605601|SUPERIORITY||Normal Distribution Approximation|-49.8|||||TWO_SIDED|95.0|-70.4|-29.2||||||Serotype 3- Difference in positive response, Group A1 minus Group B||-29.2|-70.4|
72537578|NCT02545868|144605601|SUPERIORITY||Normal Distribution Approximation|-56.0|||||TWO_SIDED|95.0|-75.7|-36.3||||||Serotype 4- Difference in positive response, Group A1 minus Group B||-36.3|-75.7|
72537579|NCT02545868|144605601|SUPERIORITY||Normal Distribution Approximation|-58.3|||||TWO_SIDED|95.0|-76.4|-40.3||||||Serotype 5- Difference in positive response, Group A1 minus Group B||-40.3|-76.4|
72537580|NCT02545868|144605601|SUPERIORITY||Normal Distribution Approximation|-34.0|||||TWO_SIDED|95.0|-55.7|-12.2||||||Serotype 6B- Difference in positive response, Group A1 minus Group B||-12.2|-55.7|
72537581|NCT02545868|144605601|SUPERIORITY||Normal Distribution Approximation|-42.5|||||TWO_SIDED|95.0|-61.8|-23.2||||||Serotype 7F- Difference in positive response, Group A1 minus Group B||-23.2|-61.8|
72537582|NCT02545868|144605601|SUPERIORITY||Normal Distribution Approximation|-42.2|||||TWO_SIDED|95.0|-60.6|-23.8||||||Serotype 8- Difference in positive response, Group A1 minus Group B||-23.8|-60.6|
72537583|NCT02545868|144605601|SUPERIORITY||Normal Distribution Approximation|-37.2|||||TWO_SIDED|95.0|-58.9|-15.5||||||Serotype 9N- Difference in positive response, Group A1 minus Group B||-15.5|-58.9|
72537584|NCT02545868|144605601|SUPERIORITY||Normal Distribution Approximation|-36.6|||||TWO_SIDED|95.0|-57.3|-16.0||||||Serotype 9V- Difference in positive response, Group A1 minus Group B||-16.0|-57.3|
72537585|NCT02545868|144605601|SUPERIORITY||Normal Distribution Approximation|-62.1|||||TWO_SIDED|95.0|-80.8|-43.5||||||Serotype 10A- Difference in positive response, Group A1 minus Group B||-43.5|-80.8|
72537586|NCT02545868|144605601|SUPERIORITY||Normal Distribution Approximation|-50.1|||||TWO_SIDED|95.0|-71.0|-29.2||||||Serotype 11A- Difference in positive response, Group A1 minus Group B||-29.2|-71.0|
72537587|NCT02545868|144605601|SUPERIORITY||Normal Distribution Approximation|-56.8|||||TWO_SIDED|95.0|-76.9|-36.8||||||Serotype 12F- Difference in positive response, Group A1 minus Group B||-36.8|-76.9|
72537588|NCT02545868|144605601|SUPERIORITY||Normal Distribution Approximation|-20.8|||||TWO_SIDED|95.0|-41.4|-0.2||||||Serotype 14- Difference in positive response, Group A1 minus Group B||-0.2|-41.4|
72537589|NCT02545868|144605601|SUPERIORITY||Normal Distribution Approximation|-52.8|||||TWO_SIDED|95.0|-72.8|-32.7||||||Serotype 15B- Difference in positive response, Group A1 minus Group B||-32.7|-72.8|
72537590|NCT02545868|144605601|SUPERIORITY||Normal Distribution Approximation|-46.3|||||TWO_SIDED|95.0|-66.8|-25.8||||||Serotype 17F- Difference in positive response, Group A1 minus Group B||-25.8|-66.8|
72537591|NCT02545868|144605601|SUPERIORITY||Normal Distribution Approximation|-42.5|||||TWO_SIDED|95.0|-61.8|-23.2||||||Serotype 18C- Difference in positive response, Group A1 minus Group B||-23.2|-61.8|
72537592|NCT02545868|144605601|SUPERIORITY||Normal Distribution Approximation|-30.2|||||TWO_SIDED|95.0|-50.6|-9.7||||||Serotype 19A- Difference in positive response, Group A1 minus Group B||-9.7|-50.6|
72537593|NCT02545868|144605601|SUPERIORITY||Normal Distribution Approximation|-46.3|||||TWO_SIDED|95.0|-66.8|-25.8||||||Serotype 19F- Difference in positive response, Group A1 minus Group B||-25.8|-66.8|
72537594|NCT02545868|144605601|SUPERIORITY||Normal Distribution Approximation|-59.5|||||TWO_SIDED|95.0|-79.0|-40.0||||||Serotype 20- Difference in positive response, Group A1 minus Group B||-40.0|-79.0|
72537595|NCT02545868|144605601|SUPERIORITY||Normal Distribution Approximation|-52.5|||||TWO_SIDED|95.0|-72.1|-32.8||||||Serotype 22F- Difference in positive response, Group A1 minus Group B||-32.8|-72.1|
72537596|NCT02545868|144605601|SUPERIORITY||Normal Distribution Approximation|-28.1|||||TWO_SIDED|95.0|-50.7|-5.4||||||Serotype 23F- Difference in positive response, Group A1 minus Group B||-5.4|-50.7|
72537597|NCT02545868|144605601|SUPERIORITY||Normal Distribution Approximation|-49.0|||||TWO_SIDED|95.0|-68.2|-29.7||||||Serotype 33F- Difference in positive response, Group A1 minus Group B||-29.7|-68.2|
72537598|NCT02545868|144605601|SUPERIORITY||Normal Distribution Approximation|-61.8|||||TWO_SIDED|95.0|-78.1|-45.4||||||Serotype 1- Difference in positive response, Group A2 minus Group B||-45.4|-78.1|
72537599|NCT02545868|144605601|SUPERIORITY||Normal Distribution Approximation|-52.9|||||TWO_SIDED|95.0|-70.6|-35.3||||||Serotype 2- Difference in positive response, Group A2 minus Group B||-35.3|-70.6|
72537600|NCT02545868|144605601|SUPERIORITY||Normal Distribution Approximation|-55.9|||||TWO_SIDED|95.0|-75.3|-36.5||||||Serotype 3- Difference in positive response, Group A2 minus Group B||-36.5|-75.3|
72537601|NCT02545868|144605601|SUPERIORITY||Normal Distribution Approximation|-64.7|||||TWO_SIDED|95.0|-82.6|-46.8||||||Serotype 4- Difference in positive response, Group A2 minus Group B||-46.8|-82.6|
72537602|NCT02545868|144605601|SUPERIORITY||Normal Distribution Approximation|-52.9|||||TWO_SIDED|95.0|-70.6|-35.3||||||Serotype 5- Difference in positive response, Group A2 minus Group B||-35.3|-70.6|
72537603|NCT02545868|144605601|SUPERIORITY||Normal Distribution Approximation|-38.2|||||TWO_SIDED|95.0|-59.3|-17.2||||||Serotype 6B- Difference in positive response, Group A2 minus Group B||-17.2|-59.3|
72537604|NCT02545868|144605601|SUPERIORITY||Normal Distribution Approximation|-58.8|||||TWO_SIDED|95.0|-76.7|-40.9||||||Serotype 7F- Difference in positive response, Group A2 minus Group B||-40.9|-76.7|
72537605|NCT02545868|144605601|SUPERIORITY||Normal Distribution Approximation|-29.4|||||TWO_SIDED|95.0|-46.1|-12.7||||||Serotype 8- Difference in positive response, Group A2 minus Group B||-12.7|-46.1|
72537606|NCT02545868|144605601|SUPERIORITY||Normal Distribution Approximation|-35.3|||||TWO_SIDED|95.0|-56.4|-14.2||||||Serotype 9N- Difference in positive response, Group A2 minus Group B||-14.2|-56.4|
72537607|NCT02545868|144605601|SUPERIORITY||Normal Distribution Approximation|-38.2|||||TWO_SIDED|95.0|-58.2|-18.2||||||Serotype 9V- Difference in positive response, Group A2 minus Group B||-18.2|-58.2|
72537608|NCT02545868|144605601|SUPERIORITY||Normal Distribution Approximation|-61.8|||||TWO_SIDED|95.0|-79.8|-43.7||||||Serotype 10A- Difference in positive response, Group A2 minus Group B||-43.7|-79.8|
72537609|NCT02545868|144605601|SUPERIORITY||Normal Distribution Approximation|-38.2|||||TWO_SIDED|95.0|-59.3|-17.2||||||Serotype 11A- Difference in positive response, Group A2 minus Group B||-17.2|-59.3|
72537610|NCT02545868|144605601|SUPERIORITY||Normal Distribution Approximation|-58.8|||||TWO_SIDED|95.0|-78.0|-39.6||||||Serotype 12F- Difference in positive response, Group A2 minus Group B||-39.6|-78.0|
72537611|NCT02545868|144605601|SUPERIORITY||Normal Distribution Approximation|-17.6|||||TWO_SIDED|95.0|-37.4|2.1||||||Serotype 14- Difference in positive response, Group A2 minus Group B||2.1|-37.4|
72537612|NCT02545868|144605601|SUPERIORITY||Normal Distribution Approximation|-50.0|||||TWO_SIDED|95.0|-69.6|-30.4||||||Serotype 15B- Difference in positive response, Group A2 minus Group B||-30.4|-69.6|
72537613|NCT02545868|144605601|SUPERIORITY||Normal Distribution Approximation|-44.1|||||TWO_SIDED|95.0|-64.0|-24.2||||||Serotype 17F- Difference in positive response, Group A2 minus Group B||-24.2|-64.0|
72537614|NCT02545868|144605601|SUPERIORITY||Normal Distribution Approximation|-61.8|||||TWO_SIDED|95.0|-79.4|-44.2||||||Serotype 18C- Difference in positive response, Group A2 minus Group B||-44.2|-79.4|
72537615|NCT02545868|144605601|SUPERIORITY||Normal Distribution Approximation|-52.9|||||TWO_SIDED|95.0|-72.3|-33.6||||||Serotype 19A- Difference in positive response, Group A2 minus Group B||-33.6|-72.3|
72537616|NCT02545868|144605601|SUPERIORITY||Normal Distribution Approximation|-58.8|||||TWO_SIDED|95.0|-77.6|-40.1||||||Serotype 19F- Difference in positive response, Group A2 minus Group B||-40.1|-77.6|
72537617|NCT02545868|144605601|SUPERIORITY||Normal Distribution Approximation|-70.6|||||TWO_SIDED|95.0|-87.4|-53.8||||||Serotype 20- Difference in positive response, Group A2 minus Group B||-53.8|-87.4|
72537618|NCT02545868|144605601|SUPERIORITY||Normal Distribution Approximation|-67.6|||||TWO_SIDED|95.0|-84.8|-50.5||||||Serotype 22F- Difference in positive response, Group A2 minus Group B||-50.5|-84.8|
72537619|NCT02545868|144605601|SUPERIORITY||Normal Distribution Approximation|-47.1|||||TWO_SIDED|95.0|-68.0|-26.1||||||Serotype 23F- Difference in positive response, Group A2 minus Group B||-26.1|-68.0|
72537620|NCT02545868|144605601|SUPERIORITY||Normal Distribution Approximation|-50.0|||||TWO_SIDED|95.0|-68.5|-31.5||||||Serotype 33F- Difference in positive response, Group A2 minus Group B||-31.5|-68.5|
72369079|NCT01262989|144248170|NON_INFERIORITY_OR_EQUIVALENCE|This is a bioequivalence study performed to support the register of tamsulosin hydrochloride, produced by Synthon BV, as a branded generic, to be marketed by GlaxoSmithKline Brasil Ltda., according to the requirements of the Brazilian Regulatory Agency - National Agency of Sanitary Surveillance (ANVISA).|Ratio T formulation/R formulation|102.79||||||90.0|96.99|108.93|||||The ratios between the geometric means of the test (T) and reference (R) formulations was calculated.|||108.93|96.99|
72537621|NCT02545868|144605603|SUPERIORITY||Normal Distribution Approximation|-25.5|||||TWO_SIDED|95.0|-41.6|-9.5||||||Strain = H1N1CA09 (Group A2 minus Group B)||-9.5|-41.6|
72537622|NCT02545868|144605603|SUPERIORITY||Normal Distribution Approximation|-14.0|||||TWO_SIDED|95.0|-35.2|7.3||||||Strain = BPHU13 (Group A2 minus Group B)||7.3|-35.2|
72537623|NCT02545868|144605603|SUPERIORITY||Normal Distribution Approximation|-25.9|||||TWO_SIDED|95.0|-45.5|-6.4||||||Strain = H3N2SW13 (Group A2 minus Group B)||-6.4|-45.5|
72537624|NCT02545868|144605603|SUPERIORITY||Normal Distribution Approximation|-19.4|||||TWO_SIDED|95.0|-50.7|11.8||||||Strain = BBRIS08 (Group A2 minus Group B)||11.8|-50.7|
72537625|NCT02545868|144605603|SUPERIORITY||Normal Distribution Approximation|-3.3|||||TWO_SIDED|95.0|-49.4|42.7||||||Strain = AHK4801 (Group A2 minus Group B)||42.7|-49.4|
72537626|NCT02545868|144605604|SUPERIORITY||Normal Distribution Approximation|-41.8|||||TWO_SIDED|95.0|-61.9|-21.7||||||Strain = H1N1CA09 (Group A2 minus Group B)||-21.7|-61.9|
72537627|NCT02545868|144605604|SUPERIORITY||Normal Distribution Approximation|-37.6|||||TWO_SIDED|95.0|-59.7|-15.5||||||Strain = BPHU13 (Group A2 minus Group B)||-15.5|-59.7|
72537628|NCT02545868|144605604|SUPERIORITY||Normal Distribution Approximation|-59.5|||||TWO_SIDED|95.0|-78.2|-40.7||||||Strain = H3N2SW13 (Group A2 minus Group B)||-40.7|-78.2|
72409180|NCT04154631|144326819|SUPERIORITY||Time by treatment interaction coeff.|-6.72|||<|0.001|TWO_SIDED||||||Intent-to-treat, multilevel modeling|||Treatment condition (Standard/Adapted TranS-C versus UC-DT) on change in psychiatric symptoms from pre to post.||||<0.001
72537629|NCT02545868|144605604|SUPERIORITY||Normal Distribution Approximation|-45.6|||||TWO_SIDED|95.0|-76.0|-15.1||||||Strain = BBRIS08 (Group A2 minus Group B)||-15.1|-76.0|
72537630|NCT02545868|144605604|SUPERIORITY||Normal Distribution Approximation|-3.3|||||TWO_SIDED|95.0|-49.4|42.7||||||Strain = AHK4801 (Group A2 minus Group B)||42.7|-49.4|
72537631|NCT02545868|144605605|SUPERIORITY||Normal Distribution Approximation|-61.3|||||TWO_SIDED|95.0|-80.2|-42.3||||||Strain = H1N1CA09 - Difference in at least 4-fold response, Group A2 minus Group B||-42.3|-80.2|
72537632|NCT02545868|144605605|SUPERIORITY||Normal Distribution Approximation|-54.8|||||TWO_SIDED|95.0|-75.3|-34.4||||||Strain = BPHU13 - Difference in at least 4-fold response, Group A2 minus Group B||-34.4|-75.3|
72537633|NCT02545868|144605605|SUPERIORITY||Normal Distribution Approximation|-82.3|||||TWO_SIDED|95.0|-97.1|-67.5||||||Strain = H3N2SW13 - Difference in at least 4-fold response, Group A2 minus Group B||-67.5|-97.1|
72537634|NCT02545868|144605605|SUPERIORITY||Normal Distribution Approximation|-36.7|||||TWO_SIDED|95.0|-67.2|-6.1||||||Strain = BBRIS08 - Difference in at least 4-fold response, Group A2 minus Group B||-6.1|-67.2|
72537635|NCT02545868|144605605|SUPERIORITY||Normal Distribution Approximation|-6.7|||||TWO_SIDED|95.0|-63.8|50.5||||||Strain = AHK4801 - Difference in at least 4-fold response, Group A2 minus Group B||50.5|-63.8|
72537636|NCT02545868|144605606|SUPERIORITY||Normal Distribution Approximation|-61.3|||||TWO_SIDED|95.0|-80.2|-42.3||||||Strain = H1N1CA09 (Group A2 minus Group B) \[FDA\]||-42.3|-80.2|
72537637|NCT02545868|144605606|SUPERIORITY||Normal Distribution Approximation|-46.0|||||TWO_SIDED|95.0|-88.0|-4.0||||||Strain = H1N1CA09 (Group A2 minus Group B) \[Protocol\]||-4.0|-88.0|
72537638|NCT02545868|144605606|SUPERIORITY||Normal Distribution Approximation|-57.9|||||TWO_SIDED|95.0|-77.7|-38.1||||||Strain = BPHU13 (Group A2 minus Group B) \[FDA\]||-38.1|-77.7|
72537639|NCT02545868|144605606|SUPERIORITY||Normal Distribution Approximation|-55.6|||||TWO_SIDED|95.0|-88.0|-23.1||||||Strain = BPHU13 (Group A2 minus Group B) \[Protocol\]||-23.1|-88.0|
72537640|NCT02545868|144605606|SUPERIORITY||Normal Distribution Approximation|-78.5|||||TWO_SIDED|95.0|-94.8|-62.2||||||Strain = H3N2SW13 (Group A2 minus Group B) \[FDA\]||-62.2|-94.8|
72537641|NCT02545868|144605606|SUPERIORITY||Normal Distribution Approximation|-57.8|||||TWO_SIDED|95.0|-100.0|-13.4||||||Strain = H3N2SW13 (Group A2 minus Group B) \[Protocol\]||-13.4|-100.0|
72537642|NCT02545868|144605606|SUPERIORITY||Normal Distribution Approximation|-36.7|||||TWO_SIDED|95.0|-67.2|-6.1||||||Strain = BBRIS08 (Group A2 minus Group B) \[FDA\]||-6.1|-67.2|
72537643|NCT02545868|144605606|SUPERIORITY||Normal Distribution Approximation|-25.0|||||TWO_SIDED|95.0|-67.4|17.4||||||Strain = BBRIS08 (Group A2 minus Group B) \[Protocol\]||17.4|-67.4|
72537644|NCT02545868|144605606|SUPERIORITY||Normal Distribution Approximation|-6.7|||||TWO_SIDED|95.0|-63.8|50.5||||||Strain = AHK4801 (Group A2 minus Group B) \[FDA\]||50.5|-63.8|
72537645|NCT01777191|144605632|SUPERIORITY_OR_OTHER_LEGACY|||||||0.248|TWO_SIDED||||||Fisher Exact|||||||0.248
72537646|NCT01932801|144605635|SUPERIORITY|||||||0.461||||||Denotes exact fit for the omnibus model|Chi-squared|Complete omnibus model stats: χ2(18, N=308) = 17.93, CFI = 1.00, RMSEA \< .001, SRMR = .07||"We used piecewise growth modeling to test various treatment arm effects on this outcome. Because there is currently no appropriate way to report on piecewise growth models in clinicaltrials.gov reporting tables, we are reporting the omnibus model statistics on this page called analysis 1 and select parameters representing certain treatment arm effects on subsequent analysis pages. However, we note these do not constitute separate analyses, but various parameters within a single SEM model."||||.461
72626878|NCT04464473|144782794|SUPERIORITY|||||||0.1082|||||||ANOVA|Interaction of intervention (MFG-cTBS, FPl-cTBS, S1), Temporal Control, and Contextual Control on error rate||||||0.1082
72626879|NCT04464473|144782794|SUPERIORITY|||||||0.0659|||||||ANOVA|Interaction of intervention (MFG-cTBS, FPl-cTBS, S1), phase (sub-task, return), Temporal Control, and Contextual Control on error rate||||||0.0659
72626880|NCT04464473|144782795|SUPERIORITY|||||||0.0211|||||||ANOVA|Interaction between visit (Baseline, MFG-cTBS, FPl-cTBS, S1-cTBS) and temporal control in reaction time||||||0.0211
72626881|NCT04464473|144782795|SUPERIORITY|||||||0.4964|||||||ANOVA|Interaction between visit (Baseline, MFG-cTBS, FPl-cTBS, S1-cTBS), phase (sub-task, return), and temporal control in reaction time||||||0.4964
72537647|NCT01932801|144605635|SUPERIORITY||Slope|-0.48||||0.01|TWO_SIDED|95.0|-0.79|-0.18||Linear effects of HaRT-A+XR-NTX compared to services-as usual control during treatment period|z score for parameters||Linear effects of HaRT-A+XR-NTX compared to services-as usual control (one of three dummy-coded variables)|"These are select parameters for treatment arm effects that are subordinate to the omnibus model statistics in the table called analysis 1. These are not separate analyses, but select parameters within a single SEM model. For more familiar formats, please see the related publications page, especially see https://doi.org/10.1016/s2215-0366(20)30489-2"||-.18|-.79|.01
72537648|NCT01932801|144605635|SUPERIORITY||Slope|-0.41||||0.01|TWO_SIDED|95.0|-0.67|-0.15|||z||Linear effects of HaRT-A+XR-NTX compared to services-as usual control (one of three dummy-coded variables) during treatment period|"These are select parameters for treatment arm effects that are subordinate to the omnibus model statistics in the table called analysis 1. These are not separate analyses, but select parameters within a single SEM model. For more familiar formats, please see the related publications page, especially see https://doi.org/10.1016/s2215-0366(20)30489-2"||-.15|-.67|.01
72537649|NCT01932801|144605635|SUPERIORITY||Slope|-0.23||||0.19|TWO_SIDED|95.0|-0.52|0.06|||z||Linear effects of HaRT-A+XR-NTX compared to services-as usual control (one of three dummy-coded variables) during treatment period|"These are select parameters for treatment arm effects that are subordinate to the omnibus model statistics in the table called analysis 1. These are not separate analyses, but select parameters within a single SEM model. For more familiar formats, please see the related publications page, especially see https://doi.org/10.1016/s2215-0366(20)30489-2"||.06|-.52|.19
72537650|NCT01932801|144605636|SUPERIORITY|||||||0.347||||||Denotes exact fit for the omnibus model|Chi-squared|complete omnibus model statistics: χ2(20, N=308) = 21.89, CFI = 1.00, RMSEA = .02, SRMR = .03||"We used piecewise growth modeling to test various treatment arm effects on this outcome. Because there is currently no appropriate way to report on piecewise growth models in clinicaltrials.gov reporting tables, we are reporting the omnibus model statistics on this page called analysis 1 and select parameters representing certain treatment arm effects on subsequent analysis pages. However, we note these do not constitute separate analyses, but various parameters within a single SEM model."||||.347
72537651|NCT01932801|144605636|SUPERIORITY||Slope|-2.22||||0.002|TWO_SIDED|95.0|-3.39|-1.06||Linear effects of HaRT-A+XR-NTX compared to services-as usual control during treatment period (one of three dummy-coded variables)|z||Linear effects of HaRT-A+XR-NTX compared to services-as usual control during treatment period (one of three dummy-coded variables)|"These are select parameters for treatment arm effects that are subordinate to the omnibus model statistics in the table called analysis 1. These are not separate analyses, but select parameters within a single SEM model. For more familiar formats, please see the related publications page, especially see https://doi.org/10.1016/s2215-0366(20)30489-2"||-1.06|-3.39|.002
72537652|NCT01932801|144605636|SUPERIORITY||Slope|-0.82||||0.208|TWO_SIDED|95.0|-1.89|0.25||Linear effects of HaRT-A+placebo compared to services-as usual control during treatment period (one of three dummy-coded variables)|z||Linear effects of HaRT-A+placebo compared to services-as usual control during treatment period (one of three dummy-coded variables)|"These are select parameters for treatment arm effects that are subordinate to the omnibus model statistics in the table called analysis 1. These are not separate analyses, but select parameters within a single SEM model. For more familiar formats, please see the related publications page, especially see https://doi.org/10.1016/s2215-0366(20)30489-2"||.25|-1.89|.208
72537653|NCT01932801|144605636|SUPERIORITY||Slope|-1.58||||0.025|TWO_SIDED|95.0|-2.73|-0.42||Linear effects of HaRT-A only compared to services-as usual control during treatment period (one of three dummy-coded variables)|z||Linear effects of HaRT-A only compared to services-as usual control during treatment period (one of three dummy-coded variables)|"These are select parameters for treatment arm effects that are subordinate to the omnibus model statistics in the table called analysis 1. These are not separate analyses, but select parameters within a single SEM model. For more familiar formats, please see the related publications page, especially see https://doi.org/10.1016/s2215-0366(20)30489-2"||-.42|-2.73|.025
72626882|NCT04464473|144782795|SUPERIORITY|||||||0.3129|||||||ANOVA|Interaction between intervention (MFG-cTBS, FPl-cTBS, S1-cTBS) and temporal control in reaction time||||||0.3129
72626883|NCT04464473|144782795|SUPERIORITY|||||||0.5439|||||||ANOVA|Interaction between intervention (MFG-cTBS, FPl-cTBS, S1-cTBS), phase (sub-task, return), and temporal control in reaction time||||||0.5439
72626884|NCT04464473|144782796|SUPERIORITY|||||||0.0344|||||||ANOVA|Interaction between visit (Baseline, MFG-cTBS, FPl-cTBS, S1-cTBS) and contextual control in reaction time||||||0.0344
72409181|NCT04154631|144326819|SUPERIORITY||Coefficient of indirect effect|-1.86||||0.08|TWO_SIDED|95.0|-3.93|-0.21|||SEM|||Structural equation modeling (SEM) was used to test whether the relationship between TranS-C condition (Immediate vs. UC-DT) and psychiatric symptoms (Diagnostic and Statistical Manual of Mental Disorders Cross-Cutting Symptom Measure) at post was mediated by sleep disturbance (PROMIS-SD) at post. The parameter of interest was the indirect effect.||-0.21|-3.93|0.08
72626885|NCT04464473|144782796|SUPERIORITY|||||||0.5113|||||||ANOVA|Interaction between visit (Baseline, MFG-cTBS, FPl-cTBS, S1-cTBS), phase (sub-task, return), and contextual control in reaction time||||||0.5113
72626886|NCT04464473|144782796|SUPERIORITY|||||||0.0301|||||||ANOVA|Interaction between intervention (MFG-cTBS, FPl-cTBS, S1-cTBS) and contextual control in reaction time||||||0.0301
72626887|NCT04464473|144782796|SUPERIORITY|||||||0.6931|||||||ANOVA|Interaction between intervention (MFG-cTBS, FPl-cTBS, S1-cTBS), phase (sub-task, return), and contextual control in reaction time||||||0.6931
72626888|NCT04464473|144782797|SUPERIORITY|||||||0.0189|||||||ANOVA|Interaction of visit (Baseline, MFG-cTBS, FPl-cTBS, S1-cTBS), temporal control, and contextual control on reaction time||||||0.0189
72537654|NCT01932801|144605637|SUPERIORITY|||||||0.028||||||"p value reflects omnibus model close fit"|Chi-squared|χ2(13, N=308) = 24.34, CFI = .98, RMSEA = .05, SRMR = .03||"We used piecewise growth modeling to test various treatment arm effects on this outcome. Because there is currently no appropriate way to report on piecewise growth models in clinicaltrials.gov reporting tables, we are reporting the omnibus model statistics on this page called analysis 1 and select parameters representing certain treatment arm effects on subsequent analysis pages. However, we note these do not constitute separate analyses, but various parameters within a single SEM model."||||.028
72537655|NCT01932801|144605637|SUPERIORITY||Slope|-4.42||||0.047|TWO_SIDED|95.0|-8.09|-0.76||Linear effects of HaRT-A+XR-NTX compared to services-as usual control during treatment period (one of three dummy-coded variables)|z||Linear effects of HaRT-A+XR-NTX compared to services-as usual control during treatment period (one of three dummy-coded variables)|"These are select parameters for treatment arm effects that are subordinate to the omnibus model statistics in the table called analysis 1. These are not separate analyses, but select parameters within a single SEM model. For more familiar formats, please see the related publications page, especially see https://doi.org/10.1016/s2215-0366(20)30489-2"||-.76|-8.09|.047
72537656|NCT01932801|144605637|SUPERIORITY||Slope|-5.95||||0.009|TWO_SIDED|95.0|-9.72|-2.19||Linear effects of HaRT-A+placebo compared to services-as usual control during treatment period (one of three dummy-coded variables)|z||Linear effects of HaRT-A+placebo compared to services-as usual control during treatment period (one of three dummy-coded variables)|"These are select parameters for treatment arm effects that are subordinate to the omnibus model statistics in the table called analysis 1. These are not separate analyses, but select parameters within a single SEM model. For more familiar formats, please see the related publications page, especially see https://doi.org/10.1016/s2215-0366(20)30489-2"||-2.19|-9.72|.009
72537657|NCT01932801|144605637|SUPERIORITY||Slope|-4.12||||0.072|TWO_SIDED|95.0|-7.88|-0.36||Linear effects of HaRT-A only compared to services-as usual control during treatment period (one of three dummy-coded variables)|z||Linear effects of HaRT-A only compared to services-as usual control during treatment period (one of three dummy-coded variables)|"These are select parameters for treatment arm effects that are subordinate to the omnibus model statistics in the table called analysis 1. These are not separate analyses, but select parameters within a single SEM model. For more familiar formats, please see the related publications page, especially see https://doi.org/10.1016/s2215-0366(20)30489-2"||-.36|-7.88|.072
72537658|NCT01932801|144605638|OTHER|Mediation tested using the product of coefficients (a\*b) approach (MacKinnon et al, 2002).|Slope|-0.12|STANDARD_ERROR_OF_MEAN|0.24||0.6|TWO_SIDED||||||z||We used growth modeling to test mediators of the treatment effect, truncated for during-treatment effects. This analysis entails all four treatment arms; however, this specific contrast is for the XR-NTX vs control group effects on alcohol frequency.|This was a mediation analysis (i.e., multiplication of regression coefficients for the regression of readiness for change slope on group (a-paths) and for the regression of alcohol outcome slopes on readiness (b-paths), where a\*b is considered the mediated effect) for during-treatment effects (baseline to week 12).||||.6
72537659|NCT01932801|144605638|OTHER|Mediation tested using the product of coefficients (a\*b) approach (MacKinnon et al, 2002).|Slope|-0.04|STANDARD_ERROR_OF_MEAN|0.18||0.83|TWO_SIDED||||||z||We used growth modeling to test mediators of the treatment effect, truncated for during-treatment effects. This analysis entails all four treatment arms; however, this specific contrast is for the XR-NTX vs control group effects on alcohol frequency.|This was a mediation analysis (i.e., multiplication of regression coefficients for the regression of readiness for change slope on group (a-paths) and for the regression of alcohol outcome slopes on readiness (b-paths), where a\*b is considered the mediated effect) for during-treatment effects (baseline to week 12).||||.83
72573667|NCT00191113|144674168|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.0|||<|0.001||95.0|0.9|1.2|||ANCOVA|Model includes baseline height SDS, baseline age, treatment, and interactions. Age and interactions terms removed when not significant.|"Effect direction is As-Treated Growth Hormone minus As-Treated No Growth Hormone"|Estimation analysis of the magnitude of effect of treatment with growth hormone upon Final Height. Null hypothesis is no effect of growth hormone upon attained height standard deviation score (National Center for Health Statistics).||1.2|0.9|<0.001
72573668|NCT00191113|144674169|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.1|||<|0.001||95.0|0.9|1.3|||ANCOVA|||||1.3|0.9|<0.001
72573669|NCT00191113|144674170|SUPERIORITY_OR_OTHER||Mean Difference (Net)|6.9|||<|0.001||95.0|5.7|8.1|||ANCOVA|||||8.1|5.7|<0.001
72573670|NCT00191113|144674171|SUPERIORITY_OR_OTHER||||||>|0.999||95.0|||||Fisher Exact|||||||>0.999
72573671|NCT00191113|144674172|SUPERIORITY_OR_OTHER|||||||0.744||95.0|||||Fisher Exact|||||||0.744
72573672|NCT00191113|144674173|SUPERIORITY_OR_OTHER|||||||0.073||95.0|||||Fisher Exact|||||||0.073
72573673|NCT00191113|144674174|SUPERIORITY_OR_OTHER||||||>|0.999||95.0|||||Fisher Exact|||Comparison of proportion of patients with any category of hearing loss between As-Treated Growth Hormone group and As-Treated No Growth Hormone.||||>0.999
72573674|NCT00191113|144674175|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.492||||0.419||95.0|-8.631|3.646|||ANOVA||Direction of estimated treatment effect is Humatrope minus Control|||3.646|-8.631|0.419
72573675|NCT00191113|144674177|SUPERIORITY_OR_OTHER|||||||0.545||95.0|||||Fisher Exact|||||||0.545
72573676|NCT00191113|144674179|SUPERIORITY_OR_OTHER||||||>|0.999||95.0|||||Fisher Exact|||||||>0.999
72573677|NCT00191113|144674181|SUPERIORITY_OR_OTHER||||||>|0.999||95.0|||||Fisher Exact|||||||>0.999
72573678|NCT00191113|144674182|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.007||||0.945||95.0|-0.199|0.186|||ANOVA||Direction of estimated treatment effect is Humatrope minus Control|||0.186|-0.199|0.945
72369080|NCT01262989|144248171|NON_INFERIORITY_OR_EQUIVALENCE|This is a bioequivalence study performed to support the register of tamsulosin hydrochloride, produced by Synthon BV, as a branded generic, to be marketed by GlaxoSmithKline Brasil Ltda., according to the requirements of the Brazilian Regulatory Agency - National Agency of Sanitary Surveillance (ANVISA).|Ratio T formulation/R formulation|94.47||||||90.0|87.59|101.9|||||The ratios between the geometric means of the test (T) and reference (R) formulations was calculated.|||101.90|87.59|
72537660|NCT01932801|144605638|OTHER|Mediation tested using the product of coefficients (a\*b) approach (MacKinnon et al, 2002).|Slope|-0.02|STANDARD_ERROR_OF_MEAN|0.17||0.89|TWO_SIDED||||||z||We used growth modeling to test mediators of the treatment effect, truncated for during-treatment effects. This analysis entails all four treatment arms; however, this specific contrast is for the HaRT-A vs control group effects on alcohol frequency.|This was a mediation analysis (i.e., multiplication of regression coefficients for the regression of readiness for change slope on group (a-paths) and for the regression of alcohol outcome slopes on readiness (b-paths), where a\*b is considered the mediated effect) for during-treatment effects (baseline to week 12).||||.89
72537661|NCT01932801|144605638|OTHER|Mediation tested using the product of coefficients (a\*b) approach (MacKinnon et al, 2002).|Slope|-0.01|STANDARD_ERROR_OF_MEAN|0.02||0.65|TWO_SIDED||||||z||We used growth modeling to test mediators of the treatment effect, truncated for during-treatment effects. This analysis entails all four treatment arms; however, this specific contrast is for the XR-NTX vs control group effects on alcohol quantity.|This was a mediation analysis (i.e., multiplication of regression coefficients for the regression of readiness for change slope on group (a-paths) and for the regression of alcohol outcome slopes on readiness (b-paths), where a\*b is considered the mediated effect) for during-treatment effects (baseline to week 12).||||.65
72537662|NCT01932801|144605638|OTHER|Mediation tested using the product of coefficients (a\*b) approach (MacKinnon et al, 2002).|Slope|-0.003|STANDARD_ERROR_OF_MEAN|0.02||0.87|TWO_SIDED||||||z||We used growth modeling to test mediators of the treatment effect, truncated for during-treatment effects. This analysis entails all four treatment arms; however, this specific contrast is for the placebo vs control group effects on alcohol quantity.|This was a mediation analysis (i.e., multiplication of regression coefficients for the regression of readiness for change slope on group (a-paths) and for the regression of alcohol outcome slopes on readiness (b-paths), where a\*b is considered the mediated effect) for during-treatment effects (baseline to week 12).||||.87
72537663|NCT01932801|144605638|OTHER|Mediation tested using the product of coefficients (a\*b) approach (MacKinnon et al, 2002).|Slope|-0.002|STANDARD_ERROR_OF_MEAN|0.02||0.91|TWO_SIDED||||||z||We used growth modeling to test mediators of the treatment effect, truncated for during-treatment effects. This analysis entails all four treatment arms; however, this specific contrast is for the HaRT-A vs control group effects on alcohol quantity.|This was a mediation analysis (i.e., multiplication of regression coefficients for the regression of readiness for change slope on group (a-paths) and for the regression of alcohol outcome slopes on readiness (b-paths), where a\*b is considered the mediated effect) for during-treatment effects (baseline to week 12).||||.91
72537664|NCT01932801|144605638|OTHER|Mediation tested using the product of coefficients (a\*b) approach (MacKinnon et al, 2002).|Slope|0.24|STANDARD_ERROR_OF_MEAN|0.38||0.54|TWO_SIDED||||||z||We used growth modeling to test mediators of the treatment effect, truncated for during-treatment effects. This analysis entails all 4 treatment arms; however, this specific contrast is for the XR-NTX vs control group effects on alcohol related harm.|This was a mediation analysis (i.e., multiplication of regression coefficients for the regression of readiness for change slope on group (a-paths) and for the regression of alcohol outcome slopes on readiness (b-paths), where a\*b is considered the mediated effect) for during-treatment effects (baseline to week 12).||||.54
72537665|NCT01932801|144605638|OTHER|Mediation tested using the product of coefficients (a\*b) approach (MacKinnon et al, 2002).|Slope|0.06|STANDARD_ERROR_OF_MEAN|0.32||0.84|TWO_SIDED||||||z||We used growth modeling to test mediators of the treatment effect, truncated for during-treatment effects. This analysis entails all 4 treatment arms; however, this specific contrast is for the placebo vs control effects on alcohol-related harm.|This was a mediation analysis (i.e., multiplication of regression coefficients for the regression of readiness for change slope on group (a-paths) and for the regression of alcohol outcome slopes on readiness (b-paths), where a\*b is considered the mediated effect) for during-treatment effects (baseline to week 12).||||.84
72573679|NCT00191113|144674184|SUPERIORITY_OR_OTHER|||||||||95.0||||P-value cannot be computed since no patients had abnormal result in either comparison group.|Fisher Exact|||||||
72573680|NCT01404923|144674201|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.4||||0.0008|TWO_SIDED||||||ANCOVA|||||||0.0008
72573681|NCT00368979|144674250|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.6||||0.003||95.0|-2.7|-0.5|||ANCOVA|||||-0.5|-2.7|0.003
72573682|NCT03786718|144674255|OTHER||||||<|0.001|||||||One sample median test|||Due to nonnormality, we used nonparametric tests to analyze the data. This analysis is a one sample median test of participants' median SUS score compared to the threshold score of 68 indicative of 'above average' usability.||||<0.001
72573683|NCT03786718|144674259|OTHER|||||||0.77|||||||Wilcoxon Signed Rank Sum test|||||||0.77
72573684|NCT03786718|144674260|OTHER|||||||0.02|||||||Wilcoxon Signed Rank Sum test|||Analysis for pre-post change in General Diet sub-scale score||||0.02
72573685|NCT03786718|144674260|OTHER|||||||0.13|||||||Wilcoxon Signed Rank Sum test|||Analysis for pre-post change in Specific Diet sub-scale score||||0.13
72369081|NCT04939415|144248192|SUPERIORITY||ratio of frequencies|0.0||||1|TWO_SIDED||||||Chi-squared, Corrected||The Chi-square metric represents the difference between the expected and observed frequencies of an event, therefore it is the ratio of frequencies.|||||1.000
72573686|NCT03786718|144674260|OTHER|||||||0.35|||||||Wilcoxon Signed Rank Sum test|||Analysis for pre-post change in Exercise sub-scale score||||0.35
72573687|NCT03786718|144674260|OTHER|||||||0.67|||||||Wilcoxon Signed Rank Sum test|||Analysis for pre-post change in Blood-glucose Testing sub-scale score||||0.67
72573688|NCT03786718|144674260|OTHER|||||||0.65|||||||Wilcoxon Signed Rank Sum test|||Analysis for pre-post change in Foot Care sub-scale score||||0.65
72573689|NCT03786718|144674261|OTHER|||||||0.001|||||||Wilcoxon Signed Rank Sum test|||||||0.001
72573690|NCT03786718|144674262|OTHER|||||||0.86|||||||Wilcoxon Signed Rank Sum test|||||||0.86
72573691|NCT03786718|144674263|OTHER|||||||0.3|||||||McNemar|||Analysis for pre-post change in knowledge of definition of A1C||||0.30
72626889|NCT04464473|144782797|SUPERIORITY|||||||0.0763|||||||ANOVA|Interaction of visit (Baseline, MFG-cTBS, FPl-cTBS, S1-cTBS), phase (sub-task, return), temporal control, and contextual control on reaction time||||||0.0763
72369082|NCT04939415|144248193|SUPERIORITY||ratio of frequencies|1.023||||1|TWO_SIDED||||||Chi-squared, Corrected||The Chi-square metric represents the difference between the expected and observed frequencies of an event, therefore it is the ratio of frequencies.|||||1.000
72537666|NCT01932801|144605638|OTHER|Mediation tested using the product of coefficients (a\*b) approach (MacKinnon et al, 2002).|Slope|0.06|STANDARD_ERROR_OF_MEAN|0.29||0.84|TWO_SIDED||||||z||We used growth modeling to test mediators of the treatment effect, truncated for during-treatment effects. This analysis entails all 4 treatment arms; however, this specific contrast is for the HaRT-A vs control group effects on alcohol related harm|This was a mediation analysis (i.e., multiplication of regression coefficients for the regression of readiness for change slope on group (a-paths) and for the regression of alcohol outcome slopes on readiness (b-paths), where a\*b is considered the mediated effect) for during-treatment effects (baseline to week 12).||||.84
72537667|NCT01932801|144605639|OTHER|Mediation tested using the product of coefficients (a\*b) approach (MacKinnon et al, 2002).|Slope|-0.41|STANDARD_ERROR_OF_MEAN|0.9||0.65|TWO_SIDED||||||z||We used growth modeling to test mediators of the treatment effect, truncated for during-treatment effects. This analysis entails two treatment arms: XR-NTX vs placebo effects on alcohol frequency and alcohol craving (PACS).|This was a mediation analysis (i.e., multiplication of regression coefficients for the regression of the craving (PACS) slope on group (a-paths) and for the regression of alcohol outcome slopes on readiness (b-paths), where a\*b is considered the mediated effect) for during-treatment effects (baseline to week 12).||||.65
72573692|NCT03786718|144674263|OTHER|||||||1|||||||McNemar|||Analysis for pre-post change in knowledge of goal range for hemoglobin A1c.||||1.00
72573693|NCT03786718|144674263|OTHER|||||||0.63|||||||McNemar|||Analysis for pre-post change in knowledge of definition of systolic blood pressure||||0.63
72573694|NCT03786718|144674263|OTHER|||||||0.02|||||||McNemar|||Analysis of pre-post change in knowledge of goal range for systolic blood pressure||||0.02
72369083|NCT04939415|144248195|SUPERIORITY||ratio of frequencies|1.073||||0.488|TWO_SIDED||||||Chi-squared, Corrected||The Chi-square metric represents the difference between the expected and observed frequencies of an event, therefore it is the ratio of frequencies.|||||0.488
72573695|NCT03786718|144674263|OTHER|||||||0.55|||||||McNemar|||Analysis of pre-post change in knowledge of definition of LDL cholesterol||||0.55
72573696|NCT03786718|144674263|OTHER|||||||0.0009|||||||McNemar|||Analysis for pre-post change in knowledge of goal range for LDL cholesterol||||0.0009
72573697|NCT03786718|144674263|OTHER|||||||1|||||||McNemar|||Analysis of pre-post change in knowledge of definition of flu vaccine||||1.00
72573698|NCT03786718|144674263|OTHER|||||||1|||||||McNemar|||Analysis of pre-post change in knowledge of recommended frequency of flu vaccination||||1.00
72573699|NCT03786718|144674264|OTHER|||||||0.15|||||||Wilcoxon Signed Rank Sum test|||||||0.15
72573700|NCT03786718|144674265|OTHER|||||||0.23|||||||McNemar|||Analysis of pre-post change in interest in information about how my diabetes health data compares to other patients like me (i.e., social comparison information)||||0.23
72369084|NCT04939415|144248196|SUPERIORITY||ratio of frequencies|2.1||||0.488|TWO_SIDED||||||Chi-squared, Corrected||The Chi-square metric represents the difference between the expected and observed frequencies of an event, therefore it is the ratio of frequencies.|||||0.488
72573701|NCT03786718|144674265|OTHER|||||||1|||||||McNemar|||Analysis of pre-post change in interest in information about how their diabetes health data compares to the goal range (i.e., goal-based comparison information)||||1.00
72573702|NCT03786718|144674265|OTHER|||||||0.51|||||||McNemar|||Analysis of pre-post change in agreement with statement: 'Information about how my diabetes health data compares to other patients like me \[social comparison information\] is useful.'||||0.51
72573703|NCT03786718|144674265|OTHER|||||||0.63|||||||McNemar|||Analysis of pre-post change in agreement with statement: 'Information about how my diabetes health data compares to the goals range \[goal-based comparison information\] is useful.||||0.63
72573704|NCT03786718|144674266|OTHER|||||||0.01|||||||Wilcoxon Signed Rank Sum test|||||||0.01
72573705|NCT00945100|144674270|SUPERIORITY_OR_OTHER||Risk difference (unadjusted)|22.0||||0.003|TWO_SIDED|95.0|8.0|35.0|||Regression, Logistic|The logistic regression model included amblyopic eye visual acuity at randomization as an adjustment covariate.||||35|8|0.003
72573706|NCT00945100|144674271|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.5||||0.01|TWO_SIDED|95.0|0.1|1.0|||ANCOVA|The ANCOVA model included interocular difference at randomization as an adjustment covariate.||||1.0|0.1|0.01
72573707|NCT00945100|144674273|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.6||||0.002|TWO_SIDED|95.0|0.3|1.0|||ANCOVA|The ANCOVA model included amblyopic eye visual acuity at randomization as an adjustment covariate.||The primary analysis was a treatment group comparison of the masked 10-week amblyopic eye visual acuity using an analysis of covariance (ANCOVA) model, adjusting for visual acuity at randomization. The analysis was a 2-sided test for efficacy to test the null hypothesis of no treatment difference, assuming 90% power and a type I error rate of 5%.||1.0|0.3|0.002
72626890|NCT04464473|144782797|SUPERIORITY|||||||0.9701|||||||ANOVA|Interaction of intervention (MFG-cTBS, FPl-cTBS, S1-cTBS), temporal control, and contextual control on reaction time||||||0.9701
72626891|NCT04464473|144782797|SUPERIORITY|||||||0.3826|||||||ANOVA|Interaction of intervention(MFG-cTBS, FPl-cTBS, S1-cTBS), phase (sub-task, return), temporal control, and contextual control on reaction time||||||0.3826
72626892|NCT04066829|144782802|OTHER||Difference in Differences|-29.2|||||TWO_SIDED|95.0|-42.2|-11.8||||||Pre and post difference in the treatment group as compared to the control group. A log transformation was used.||-11.8|-42.2|
72573708|NCT00945100|144674277|SUPERIORITY_OR_OTHER|||||||0.04||95.0|||||ANCOVA|The ANCOVA model included amblyopic eye visual acuity at randomization as an adjustment covariate.||The treatment effect within gender was assessed by including an interaction term between treatment group and gender in the ANCOVA model, adjusting for amblyopic eye visual acuity at randomization and main effects corresponding to the interaction term.||||0.04
72573709|NCT00945100|144674277|SUPERIORITY_OR_OTHER|||||||0.89||95.0|||||ANCOVA|The ANCOVA model included amblyopic eye visual acuity at randomization as an adjustment covariate.||The treatment effect within race/ethnicity was assessed by including an interaction term between treatment group and race/ethnicity in the ANCOVA model, adjusting for amblyopic eye visual acuity at randomization and main effects corresponding to the interaction term.||||0.89
72573710|NCT00945100|144674277|SUPERIORITY_OR_OTHER|||||||0.49||95.0|||||ANCOVA|The ANCOVA model included amblyopic eye visual acuity at randomization as an adjustment covariate.||The treatment effect within age at randomization was assessed by including an interaction term between treatment group and age in the ANCOVA model, adjusting for amblyopic eye visual acuity at randomization and main effects corresponding to the interaction term.||||0.49
72573711|NCT00945100|144674277|SUPERIORITY_OR_OTHER|||||||0.37||95.0|||||ANCOVA|||The treatment effect within amblyopic eye visual acuity at randomization was assessed by including an interaction term between treatment group and visual acuity in the ANCOVA model, adjusting for the main effects corresponding to the interaction term.||||0.37
72573712|NCT00945100|144674277|SUPERIORITY_OR_OTHER|||||||0.5||95.0|||||ANCOVA|The ANCOVA model included amblyopic eye visual acuity at randomization as an adjustment covariate.||The treatment effect within cause of amblyopia was assessed by including an interaction term between treatment group and amblyopia cause in the ANCOVA model, adjusting for amblyopic eye visual acuity at randomization and main effects corresponding to the interaction term.||||0.50
72573713|NCT00945100|144674279|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.5|||||TWO_SIDED|95.0|0.04|1.0|||ANCOVA|The ANCOVA model included amblyopic eye visual acuity at randomization as an adjustment covariate.||||1.0|0.04|
72573714|NCT00945100|144674287|SUPERIORITY_OR_OTHER||||||>|0.99||95.0|||||Fisher Exact|||Fisher's exact test was used to compare the proportion of participants in each treatment group with a loss of 2 or more lines in the better of the initial test and retest (if indicated) fellow eye visual acuities at the 10-week exam.||||>0.99
72573715|NCT00945100|144674289|SUPERIORITY_OR_OTHER|||||||0.12||95.0|||||Fisher Exact|||Fisher's exact test was used to compare the proportion of participants in each treatment group with a loss of 2 or more lines in the better of the initial test and retest (if indicated) fellow eye visual acuities at the final exam.||||0.12
72626893|NCT01334918|144782831|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Predefined noninferiority criterion: If the lower boundary of the 95% CI was within 0.15 of 0.78, MDCT would be determined to be noninferior to SPECT.|Agreement rate|0.87|STANDARD_ERROR_OF_MEAN|0.051|||TWO_SIDED|95.0|0.77|0.97||||||Analysis of agreement rate based on participants with 0 -1 and ≥ 2 reversible defects according to SPECT. Agreement is defined as the proportion of participants who had the same status from SPECT and MDCT, averaged across those with 2 or more reversible defects and those without, where SPECT is the reference standard.||0.97|0.77|
72626894|NCT01334918|144782836|SUPERIORITY_OR_OTHER_LEGACY||Specificity|0.95|STANDARD_ERROR_OF_MEAN|0.022|||TWO_SIDED|95.0|0.9|0.99||||||Analysis of specificity based on participants with no fixed defects according to SPECT. Specificity is defined as a proportion of true negatives that are correctly identified, using SPECT as the reference standard.||0.99|0.90|
72626895|NCT01334918|144782836|SUPERIORITY_OR_OTHER_LEGACY||Sensitivity|0.77|STANDARD_ERROR_OF_MEAN|0.117|||TWO_SIDED|95.0|0.54|1.0||||||Analysis of sensitivity based on participants with ≥ 1 fixed defect according to SPECT. Sensitivity is the proportion of true positives that are correctly identified using SPECT as the reference standard.||1.00|0.54|
72626896|NCT01409096|144782886|SUPERIORITY_OR_OTHER|||||||0.9084|TWO_SIDED||||||ANCOVA|||Baseline HRSD scores used as covariate.||||0.9084
72573716|NCT00945100|144674293|SUPERIORITY_OR_OTHER|||||||0.28||95.0|||||Wilcoxon (Mann-Whitney)|||An Exact Wilcoxon rank sum test was used for the difference between treatment groups in the distribution of levels of change in Randot Preschool Stereoacuity from randomization to 10 weeks.||||0.28
72573717|NCT00945100|144674296|SUPERIORITY_OR_OTHER|||||||0.45||95.0|||||Wilcoxon (Mann-Whitney)|||An Exact Wilcoxon rank sum test was used for the difference between treatment groups in the distribution of levels of change in Randot Preschool Stereoacuity from randomization to 10 weeks.||||0.45
72573718|NCT01781481|144674297|SUPERIORITY_OR_OTHER||Inter-rater reliability|0.87|||||TWO_SIDED||||||||Inter rater reliability for a subset of 40 patients whose Pediatric INTERMED was scored by two trained raters. The median inter-rater reliability coefficient was .87.|||||
72573719|NCT01781481|144674297|SUPERIORITY_OR_OTHER||Cronbach's Alpha|0.91|||||TWO_SIDED||||||||Overall internal consistency of the overall Pediatric INTERMED scale (34 items).|||||
72573720|NCT01781481|144674298|SUPERIORITY_OR_OTHER||||||<|0.05||||||Correlation between the biological and psychological domain scores on the Pediatric INTERMED. The threshold for significance is p\< .05.|Pearson Correlation Coefficients|||||||<0.05
72573721|NCT01781481|144674298|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\< .05.|Pearson Correlation Coefficient|||Correlation between the Biological and Social domain scores on the Pediatric INTERMED.||||<0.01
72573722|NCT01781481|144674298|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\< .05.|Pearson Correlation Coefficient|||Correlation between the Biological and Family/Caregiver Pediatric INTERMED domain scores.||||<0.01
72573723|NCT01781481|144674298|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\< .05.|Pearson Correlation Coefficient|||Correlation between Biological and Health Service Pediatric INTERMED domain scores.||||<0.01
72573724|NCT01781481|144674298|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\< .05.|Pearson Correlation Coefficient|||Correlation between Psychology and Social Pediatric INTERMED domain scores.||||<0.01
72573725|NCT01781481|144674298|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\< .05.|Pearson Correlation Coefficient|||||||<0.01
72626897|NCT01409096|144782887|SUPERIORITY_OR_OTHER|||||||0.5187|TWO_SIDED||||||ANCOVA|||Baseline IDS-SR used as a covariate.||||0.5187
72626898|NCT01409096|144782888|SUPERIORITY_OR_OTHER|||||||0.606|TWO_SIDED||||||ANOVA|||Baseline YMRS used as a covariate.||||0.6060
72626899|NCT01409096|144782889|SUPERIORITY_OR_OTHER|||||||0.511|TWO_SIDED||||||ANCOVA|||Baseline HRSA used as a covariate.||||0.5110
72626900|NCT01155050|144782907|SUPERIORITY|||||||0.296|||||||ANOVA|||The null hypothesis is that there are no differences in the outcome across groups.||||.296
72626901|NCT01155050|144782908|SUPERIORITY|||||||0.787|||||||ANOVA|||The null hypothesis is that there are no differences in the outcome across groups.||||.787
72626902|NCT01155050|144782909|SUPERIORITY|||||||0.34|||||||ANOVA|||The null hypothesis is that there are no differences in the outcome across groups.||||.340
72537668|NCT01932801|144605639|OTHER|Mediation tested using the product of coefficients (a\*b) approach (MacKinnon et al, 2002).|Slope|-0.03|STANDARD_ERROR_OF_MEAN|0.04||0.46|TWO_SIDED||||||z||We used growth modeling to test mediators of the treatment effect, truncated for during-treatment effects. This analysis entails 2 treatment arms: XR-NTX vs placebo effects on craving and alcohol quantity.|This was a mediation analysis (i.e., multiplication of regression coefficients for the regression of the alcohol craving (PACS) slope on group (a-paths) and for the regression of alcohol outcome slopes on readiness (b-paths), where a\*b is considered the mediated effect) for during-treatment effects (baseline to week 12).||||.46
72537669|NCT01932801|144605639|OTHER|Mediation tested using the product of coefficients (a\*b) approach (MacKinnon et al, 2002).|Slope|-0.57|STANDARD_ERROR_OF_MEAN|0.75||0.45|TWO_SIDED||||||z||We used growth modeling to test mediators of the treatment effect, truncated for during-treatment effects. This analysis entails two treatment arms: XR-NTX vs placebo effects on craving and alcohol-related harm|This was a mediation analysis (i.e., multiplication of regression coefficients for the regression of alcohol craving (PACS) slope on group (a-paths) and for the regression of alcohol outcome slopes on readiness (b-paths), where a\*b is considered the mediated effect) for during-treatment effects (baseline to week 12).||||.45
72537670|NCT01932801|144605640|SUPERIORITY|||||||0.95||||||Denotes exact fit for the omnibus model|Chi-squared|Complete omnibus model : χ2(12, N=308) = .75, CFI = 1.00, RMSEA \< .001, SRMR = .008||"We used piecewise growth modeling to test various treatment arm effects on this outcome. Because there is currently no appropriate way to report on piecewise growth models in clinicaltrials.gov reporting tables, we are reporting the omnibus model statistics on this page called analysis 1 and select parameters representing certain treatment arm effects on subsequent analysis pages. However, we note these do not constitute separate analyses, but various parameters within a single SEM model."||||.95
72537671|NCT01932801|144605640|SUPERIORITY||Slope|-0.04||||0.75|TWO_SIDED|95.0|-0.24|0.16||Linear effects of HaRT-A+XR-NTX compared to services-as usual control during treatment period (one of three dummy-coded variables)|Chi-squared|||"These are select parameters for treatment arm effects that are subordinate to the omnibus model statistics in the table called analysis 1. These are not separate analyses, but select parameters within a single SEM model."||.16|-.24|.75
72573726|NCT01781481|144674298|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\< .05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Psychological and Health Service Pediatric INTERMED domain scores.||||<0.01
72626903|NCT01155050|144782910|SUPERIORITY|||||||0.502|||||||ANOVA|||The null hypothesis is that there are no differences in the outcome across groups.||||.502
72537672|NCT01932801|144605640|SUPERIORITY||Slope|-0.15||||0.2|TWO_SIDED|95.0|-0.34|0.04|||Chi-squared|Linear effects of HaRT-A+placebo compared to services-as usual control during treatment period (one of three dummy-coded variables)||"These are select parameters for treatment arm effects that are subordinate to the omnibus model statistics in the table called analysis 1. These are not separate analyses, but select parameters within a single SEM model."||.04|-.34|.20
72537673|NCT01932801|144605640|SUPERIORITY||Slope|0.1||||0.39|TWO_SIDED|95.0|-0.09|0.29|||Chi-squared|Linear effects of HaRT-A compared to services-as usual control during treatment period (one of three dummy-coded variables)||"These are select parameters for treatment arm effects that are subordinate to the omnibus model statistics in the table called analysis 1. These are not separate analyses, but select parameters within a single SEM model."||.29|-.09|.39
72537674|NCT01932801|144605641|SUPERIORITY||incident rate ratio|0.98|||>|0.84|TWO_SIDED|95.0|0.83|1.16|||z|||We conducted a generalized estimating equations analysis (negative binomial distribution, log link) to test whether number of adverse events reported increased from baseline to the follow-ups differentially across placebo and XR-NTX groups||1.16|.83|>.84
72537675|NCT00315328|144605644|SUPERIORITY_OR_OTHER|||||||0.96||95.0|||||Wilcoxon (Mann-Whitney)|||Wilcoxon rank sum tests were used to assess treatment group differences in the change in Randot Preschool stereoacuity levels ( from baseline to the outcome examination).||||0.96
72573727|NCT01781481|144674298|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\< .05.|Pearson Correlation Coefficient|||Correlation between Social and Family/Caregiver Pediatric INTERMED domain scores.||||<0.01
72573728|NCT01781481|144674298|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\< .05.|Pearson Correlation Coefficient|||Correlation between Social and Health Service Pediatric INTERMED domain scores.||||<0.01
72626904|NCT01155050|144782911|SUPERIORITY|||||||0.86|||||||ANOVA|||The null hypothesis is that the outcome does not differ across the four groups.||||.860
72369085|NCT04939415|144248198|SUPERIORITY||ratio of frequencies|3.243||||0.231|TWO_SIDED||||||Chi-squared, Corrected||The Chi-square metric represents the difference between the expected and observed frequencies of an event, therefore it is the ratio of frequencies.|||||0.231
72369086|NCT04939415|144248199|SUPERIORITY||ratio of frequencies|0.034||||1|TWO_SIDED||||||Chi-squared, Corrected|The Chi-square metric represents the difference between the expected and observed frequencies of an event, therefore it is the ratio of frequencies.||||||1.000
72369087|NCT04939415|144248200|OTHER||ratio of frequencies|0.083||||1|TWO_SIDED||||||Chi-squared, Corrected|The Chi-square metric represents the difference between the expected and observed frequencies of an event, therefore it is the ratio of frequencies.||||||1.000
72626905|NCT01155050|144782912|SUPERIORITY|||||||0.634|||||||ANOVA|||The null hypothesis is that the outcome does not differ across the four groups.||||.634
72626906|NCT01155050|144782913|SUPERIORITY|||||||0.879|||||||ANOVA|||The null hypothesis is that there is no difference in the outcome across the four treatment groups.||||.879
72626907|NCT00949533|144782918|SUPERIORITY_OR_OTHER|||||||0.825|||||||Pearson Chi-Square|||||||0.825
72626908|NCT00949533|144782919|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Chi-squared|||||||> 0.05
72626909|NCT00949533|144782920|SUPERIORITY_OR_OTHER|||||||1|||||||Chi-squared|||Cough: statistical difference between 2 groups was based on chi-squared test.||||1.000
72626910|NCT00949533|144782920|SUPERIORITY_OR_OTHER|||||||0.284|||||||Chi-squared|||Rhinorrhea: statistical difference between 2 groups was based on chi-squared test.||||0.284
72626911|NCT00949533|144782920|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||Sore throat: statistical difference between 2 groups was based on fisher-exact test.||||1.000
72626912|NCT00949533|144782920|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||Shortness of breath: statistical difference between 2 groups was based on fisher-exact test.||||1.000
72626913|NCT00949533|144782920|SUPERIORITY_OR_OTHER|||||||0.487|||||||Fisher Exact|||Diarrhea: statistical difference between 2 groups was based on fisher-exact test.||||0.487
72626914|NCT00949533|144782920|SUPERIORITY_OR_OTHER|||||||0.593|||||||Fisher Exact|||Headache: statistical difference between 2 groups was based on fisher-exact test.||||0.593
72626915|NCT00949533|144782920|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||Conjunctivitis: statistical difference between 2 groups was based on fisher-exact test.||||1.000
72626916|NCT00949533|144782920|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||Vomiting: statistical difference between 2 groups was based on fisher-exact test.||||1.000
72626917|NCT00949533|144782920|SUPERIORITY_OR_OTHER|||||||0.106|||||||Fisher Exact|||Other: statistical difference between 2 groups was based on fisher-exact test.||||0.106
72626918|NCT01959529|144782922|NON_INFERIORITY|Non-inferiority of IDeg to IGlar was considered confirmed if the upper limit of the two-sided 95% confidence interval for the HR was below 1.3 or equivalent if the p-value for the one-sided test of null hypothesis (H0): HR≥1.3 against the alternative hypothesis (Ha): HR\<1.3 was less than 2.5%.|Hazard Ratio (HR)|0.908|||<|0.001|TWO_SIDED|95.0|0.781|1.055||p value : Refers to one-sided test of HR \>= 1.3 (against Ha: HR\<1.3).|Regression, Cox|||The hazard ratio (HR) (IDeg vs IGlar) was based on Cox regression with investigational medicinal product as only factor for primary analysis.||1.055|0.781|<0.001
72369088|NCT04939415|144248202|SUPERIORITY||ratio of frequencies|1.213||||0.462|TWO_SIDED||||||Chi-squared, Corrected||The Chi-square metric represents the difference between the expected and observed frequencies of an event, therefore it is the ratio of frequencies.|||||0.462
72573729|NCT01781481|144674298|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\< .05.|Pearson Correlation Coefficient|||Correlation between Family/Caregiver and Health Service Pediatric INTERMED domain scores.||||<0.01
72573730|NCT01781481|144674312|SUPERIORITY_OR_OTHER||||||>|0.05||||||The threshold for significance is p\<0.05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Biological Domain Score and IBD Disease Severity at Diagnosis||||>0.05
72573731|NCT01781481|144674312|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\< .05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Biological Domain Score and IBD Disease Severity (at time of Study Participation).||||<0.01
72626919|NCT01959529|144782923|SUPERIORITY||Rate ratio|0.601|||<|0.001|TWO_SIDED|95.0|0.476|0.759||p-value : Refers to one-sided test of RR \>= 1.0 (against Ha: RR\<1.0)|Negative binomial regression|The model included treatment (IDeg vs IGlar) as a fixed factor and was fitted using the FAS.||Superiority was considered confirmed if the upper limit of the two-sided 95% confidence interval for the rate ratio (RR) was below 1.0 or equivalent if the p-value for the one-sided test of H0: RR ≥1.0 against Ha: RR \<1.0, was less than 2.5%||0.759|0.476|<0.001
72626920|NCT01959529|144782924|SUPERIORITY||Odds Ratio (OR)|0.729|||<|0.001|TWO_SIDED|95.0|0.6|0.866||p-value: Refers to one-sided test of OR \>= 1.0 (against Ha: OR\<1.0)|Regression, Logistic|The model was logistic regression with log-link function.The model included treatment (IDeg vs IGlar) as a fixed factor and was fitted using the FAS||Superiority of IDeg to IGlar was considered confirmed if the upper limit of the two-sided 95% confidence interval for the odds ratio (OR) was below 1.0 or equivalent if the p-value for the one-sided test of H0: OR ≥1.0 against Ha: OR\<1.0, was less than 2.5%.||0.866|0.600|<0.001
72626921|NCT01440764|144782926|SUPERIORITY|||||||0.99||||||a priori threshold for significance was 0.05. Not corrected for multiple comparisons. This p-value describes the a priori analysis of comparing the furosemide test result to the saline test result.|t-test, 2 sided|||||||0.99
72626922|NCT01440764|144782926|SUPERIORITY|||||||0.32||||||a priori threshold for significance was 0.05. Not corrected for multiple comparisons. Thes p-value describes the a priori analysis of comparing the response to furosemide to the mean response to saline.|t-test, 2 sided|||||||0.32
72626923|NCT01440764|144782928|SUPERIORITY|||||||0.0006||||||a priori threshold for statistical significance was 0.05. Not adjusted for multiple comparisons.|t-test, 2 sided|||||||.0006
72626924|NCT01440764|144782928|SUPERIORITY||||||=|1e-05||||||a priori threshold for statistical significance was 0.05. Not adjusted for multiple comparisons.|t-test, 2 sided|||||||=.00001
72573732|NCT01781481|144674312|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\< .05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Biological Domain Score and Functional Disability Index (child rating).||||<0.01
72573733|NCT01781481|144674312|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\<.05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Biological Domain Score and Functional Disability Index (parent rating).||||<0.01
72626925|NCT01440764|144782928|SUPERIORITY|||||||2e-07||||||a priori threshold for significance was 0.05. Not adjusted for multiple comparisons.|t-test, 2 sided|||||||.0000002
72626926|NCT00557193|144782930|SUPERIORITY||Hazard Ratio (HR)|1.107||||0.672|ONE_SIDED|85.0||1.403||A priori significance level threshold of alpha=0.15|Log Rank||Arm C is the numerator and Arm B is the denominator of the estimated hazard ratio|A one-sided log rank test will be used for testing whether the EFS in Arm C (chemo+lest) at DL2 is greater than the EFS in Arm B (chemo). This is equivalent to testing the null hypothesis of hazard ratio (HR)=1 versus the alternative of HR\<1.||1.403||0.672
72369089|NCT04939415|144248203|SUPERIORITY||ratio of frequencies|0.153||||1|TWO_SIDED||||||Chi-squared, Corrected||The Chi-square metric represents the difference between the expected and observed frequencies of an event, therefore it is the ratio of frequencies.|||||1.000
72369090|NCT04939415|144248204|SUPERIORITY||F value|0.185||||0.668|TWO_SIDED||||||Mixed Models Analysis|Group by Day interaction||||||0.668
72369091|NCT04939415|144248205|SUPERIORITY||F value|0.032||||0.86|TWO_SIDED||||||Mixed Models Analysis||Group by Day interaction|||||0.860
72573734|NCT01781481|144674312|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\<0.05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Biological Domain Score and Impact Quality of Life: General Well Being scale.||||<0.01
72626927|NCT00652834|144782943|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0||||0.05|TWO_SIDED|95.0||||The p value is only for GSRS score comparison only.|t-test, 2 sided||The GSRS range is 1-7|"The results of the initial SBCE exams were evaluated by a visually challenged GI specialist who gave us a descriptive report. By the end of the study, we submitted the final reports to the same specialist and asked his impression on the significant changes observed in patients' exams for each GI segment (stomach and small bowel).~There were no comparison groups. Each patient is their own control. Given that this is a pilot study there is no power calculation."||||0.05
72626928|NCT00320606|144782944|OTHER||95% confidence interval using an exact b|0.6|||||TWO_SIDED|95.0|0.4|0.8|||||Proportion Success|The proportion of participants in whom immunosuppression withdrawal was attempted who are successfully withdrawn from immunosuppression are descriptively summarized with 95% confidence intervals using an exact binomial method||0.8|0.4|
72626929|NCT00320606|144782945|OTHER||Binomial Proportion|0.0|||||TWO_SIDED|95.0|0.0|0.1684|||||95% Confidence Interval Exact Binomial|The proportion of participants in whom immunosuppression (IS) withdrawal was attempted who are successfully withdrawn from immunosuppression and experience death or graft loss are descriptively summarized with 95% confidence intervals using an exact binomial method.||0.1684|0.0|
72626930|NCT00976456|144783079|NON_INFERIORITY_OR_EQUIVALENCE|The estimation was that in the pemetrexed-carboplatin plus bevacizumab Arm the median PFS will be 5.5 months. A median PFS of 4 months (5.5 - 27%) had been regarded non-inferior. Assuming the accrual period of 24 months and the whole study duration of 42 months, 246 patients had to be recruited. According to the fact, that the required statistical power of 80% will be reached by occurrence of altogether 227 events, the final analysis was done at this time point.|Hazard Ratio (HR)|1.29||||0.0583|TWO_SIDED|95.0|0.989|1.682|||Wilcoxon (Mann-Whitney)|||||1.682|0.989|0.0583
72626931|NCT00976456|144783080|NON_INFERIORITY_OR_EQUIVALENCE|The estimation was that in the pemetrexed-carboplatin plus bevacizumab Arm the median PFS will be 5.5 months. A median PFS of 4 months (5.5 - 27%) had been regarded non-inferior. Assuming the accrual period of 24 months and the whole study duration of 42 months, 246 patients had to be recruited. According to the fact, that the required statistical power of 80% will be reached by occurrence of altogether 227 events, the final analysis was done at this time Point.|Hazard Ratio (HR)|1.091||||0.3869|TWO_SIDED|95.0|0.794|1.499|||Wilcoxon (Mann-Whitney)|||||1.499|0.794|0.3869
72626932|NCT02037529|144783083|SUPERIORITY|||||||0.5623|||||||Log Rank|||||||0.5623
72537676|NCT00315328|144605645|SUPERIORITY_OR_OTHER|||||||0.78||95.0|||||Wilcoxon (Mann-Whitney)|||Wilcoxon rank sum tests used to assess treatment group differences in change in Randot Preschool stereoacuity levels ( from baseline to the outcome examination) among those with anisometropia only.||||0.78
72537677|NCT00315328|144605646|SUPERIORITY_OR_OTHER|||||||0.99||95.0|||||Wilcoxon (Mann-Whitney)|||Wilcoxon rank sum tests were used to assess treatment group differences in the change in Randot Preschool stereoacuity levels ( from baseline to the outcome examination) among patients with strabismus or combined mechanism only.||||0.99
72626933|NCT02037529|144783088|SUPERIORITY|||||||0.984|||||||Log Rank|||||||0.9840
72626934|NCT02037529|144783089|SUPERIORITY|||||||0.5968|||||||Log Rank|||||||0.5968
72626935|NCT00718315|144783097|SUPERIORITY_OR_OTHER|||||||0.481||||||Test for Binomial Ratio, where H0: P \>=61%; Ha: P \< 61% (One-tailed Test)|t-test, 1 sided|||||||0.481
72626936|NCT00718315|144783097|SUPERIORITY_OR_OTHER|||||||0.933||||||Test for Binomial Ratio, where H0: P \>=61%; Ha: P \< 61% (One-tailed Test)|t-test, 1 sided|||||||0.933
72626937|NCT00718315|144783097|SUPERIORITY_OR_OTHER|||||||0.986||||||Test for Binomial Ratio, where H0: P \>=61%; Ha: P \< 61% (One-tailed Test)|t-test, 1 sided|||||||0.986
72626938|NCT00718315|144783099|SUPERIORITY_OR_OTHER|||||||0.095|||||||Log Rank|||||||0.095
72626939|NCT00718315|144783100|SUPERIORITY_OR_OTHER|||||||0.199|||||||Chi-squared|||||||0.199
72626940|NCT00718315|144783101|SUPERIORITY_OR_OTHER|||||||0.108|||||||Chi-squared|||||||0.108
72537678|NCT00315328|144605647|SUPERIORITY_OR_OTHER|||||||0.04||95.0|||||Wilcoxon (Mann-Whitney)|||To evaluate WITHIN each treatment group whether stereoacuity changed from baseline to outcome a Wilcoxon sign-rank test was performed to evaluate whether the distribution of change from baseline was zero||||.04
72537679|NCT00315328|144605647|SUPERIORITY_OR_OTHER|||||||0.003||95.0|||||Wilcoxon (Mann-Whitney)|||To evaluate WITHIN each treatment group whether stereoacuity changed from baseline to outcome a Wilcoxon sign-rank test was performed to evaluate whether the distribution of change from baseline was zero||||0.003
72537680|NCT00315328|144605648|SUPERIORITY_OR_OTHER||||||<|0.01||95.0|||||Wilcoxon (Mann-Whitney)|Positive mean favors atropine group.||Wilcoxon rank sum tests were used to assess treatment group differences in the parent questionnaire subscale scores at 17 weeks - Social Stigma subscale.||||<0.01
72537681|NCT00315328|144605649|SUPERIORITY_OR_OTHER||||||<|0.01||95.0|||||Wilcoxon (Mann-Whitney)|Positive mean favors atropine group.||Wilcoxon rank sum tests were used to assess treatment group differences in the parent questionnaire subscale scores at 17 weeks - Compliance subscale.||||<0.01
72537682|NCT00315328|144605650|SUPERIORITY_OR_OTHER|||||||0.7||95.0|||||Wilcoxon (Mann-Whitney)|||Wilcoxon rank sum tests were used to assess treatment group differences in the parent questionnaire subscale scores at 17 weeks - Adverse events subscale.||||0.70
72537683|NCT00315328|144605651|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.07||||||95.0|-0.03|0.17||||||95% confidence interval constructed on the treatment group difference in proportion with amblyopic eye visual acuity 20/25 or better at 17 weeks.||0.17|-0.03|
72537684|NCT00315328|144605653|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.08||||||95.0|-0.02|0.18||||||95% confidence interval constructed on the treatment group difference of the proportion improving 15 or more letters from baseline to 17 weeks.||0.18|-0.02|
72369092|NCT04939415|144248206|SUPERIORITY||F value|0.035||||0.853|TWO_SIDED||||||Mixed Models Analysis||Group by Day interaction|||||0.853
72369093|NCT04939415|144248207|SUPERIORITY||F value|0.0||||0.995|TWO_SIDED||||||Mixed Models Analysis||group by day interaction|||||0.995
72369094|NCT04939415|144248208|SUPERIORITY||F value|1.27||||0.266|TWO_SIDED||||||Mixed Models Analysis|||||||0.266
72369095|NCT04939415|144248209|SUPERIORITY||F value|4.533||||0.039|TWO_SIDED||||||Mixed Models Analysis||group by day interaction is reported.|||||0.039
72369096|NCT04939415|144248209|SUPERIORITY||F Ratio|13.897|||<|0.001|TWO_SIDED||||||ANOVA|Degrees of freedom: 1,23||day 0 to day 14 for the mQFPD group were examined.||||<0.001
72369097|NCT04939415|144248209|SUPERIORITY||F ratio|0.41||||0.529|TWO_SIDED||||||ANOVA|degrees of freedom: 1,20||day 0 to day 14 for the Placebo Group were examined.||||0.529
72537685|NCT00315328|144605654|NON_INFERIORITY_OR_EQUIVALENCE|Treatment equivalence was to be declared if the ends of the 2 1-sided 95% confidence intervals constructed on the difference between adjusted mean visual acuity scores were completely contained within the designated equivalence interval of +/- 5 letters.|Mean Difference (Net)|1.2||||||95.0|-0.7|3.1|||ANCOVA|||The trial was designed to evaluate whether patching and atropine are equivalent treatments for amblyopia in children 7 to 12 years old. The sample size was computed based on a standard deviation of 17-week visual acuity scores of 10 letters, correlation between outcome and baseline visual acuity scores of 0.30 and 10% loss to follow up.||3.1|-0.7|
72573735|NCT01781481|144674312|SUPERIORITY_OR_OTHER||||||>|0.05||||||The threshold for significance is p\<0.05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Biological Domain Score and Number of Surgeries.||||>0.05
72573736|NCT01781481|144674312|SUPERIORITY_OR_OTHER||||||>|0.05||||||The threshold for significance is p\<0.05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Biological Domain Score and Number of Courses of Prednisone.||||>0.05
72573737|NCT01781481|144674312|SUPERIORITY_OR_OTHER||||||>|0.05||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||Correlation between Pediatric INTERMED Biological Domain Score and Use of Immunomodulators.||||>0.05
72573738|NCT01781481|144674312|SUPERIORITY_OR_OTHER||||||>|0.05||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||Correlation between Pediatric INTERMED Biological Domain Score and Use of ant-TNFa medications.||||>0.05
72573739|NCT01781481|144674312|SUPERIORITY_OR_OTHER||||||>|0.05||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||Correlation between Pediatric INTERMED Chronicity Item (Historical Biological) and Disease Severity at Diagnosis.||||>0.05
72573740|NCT01781481|144674312|SUPERIORITY_OR_OTHER||||||>|0.05||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||Correlation between Pediatric INTERMED Chronicity Item (Historical Biological) and Disease Severity at time of study participation (Pediatric INTERMED interview).||||>0.05
72573741|NCT01781481|144674312|SUPERIORITY_OR_OTHER||||||>|0.05||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||Correlation between Pediatric INTERMED Chronicity Item (Historical Biological) and Functional Disability Index (Child Report)||||>0.05
72573742|NCT01781481|144674312|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||Correlation between Pediatric INTERMED Chronicity Item (Historical Biological) and Functional Disability Index (Parent)||||<0.01
72573743|NCT01781481|144674312|SUPERIORITY_OR_OTHER||||||>|0.05||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||Correlation between Pediatric INTERMED Chronicity Item (Historical Biological) and Impact Quality of Life: General Well-Being.||||>0.05
72573744|NCT01781481|144674312|SUPERIORITY_OR_OTHER||||||>|0.05||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||Correlation between Pediatric INTERMED Chronicity Item (Historical Biological) and Number of Surgeries.||||>0.05
72573745|NCT01781481|144674312|SUPERIORITY_OR_OTHER||||||>|0.05||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||Correlation between Pediatric INTERMED Chronicity Item (Historical Biological) and Number of Courses of Prednisone.||||>0.05
72573746|NCT01781481|144674312|SUPERIORITY_OR_OTHER||||||<|0.05||||||The threshold for significance is p\< 0.05.|Spearman Correlation Coefficent|||Correlation between Pediatric INTERMED Chronicity Item (Historical Biological) and Use of Immunomodulators (azathioprine or methotrexate)||||<0.05
72573747|NCT01781481|144674312|SUPERIORITY_OR_OTHER||||||>|0.05||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||Correlation between Pediatric INTERMED Chronicity Item (Historical Biological) and use of anti-TNFa medications.||||>0.05
72573748|NCT01781481|144674312|SUPERIORITY_OR_OTHER||||||>|0.05||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Symptom Severity Item (Current/Biological) and Disease Severity at Diagnosis."||||>0.05
72573749|NCT01781481|144674312|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Symptom Severity Item (Current Biological) and IBD Disease Severity at time of study participation."||||<0.01
72573750|NCT01781481|144674312|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Symptom Severity Item (Current Biological) and Functional Disability Index (child rating)."||||<0.01
72573751|NCT01781481|144674312|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Symptom Severity Item (Current Biological) and Functional Disability Index (Parent Rating)"||||<0.01
72573752|NCT01781481|144674312|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Symptom Severity Item (Current Biological) and Impact Quality of Life: General Well-Being Scale"||||<0.01
72573753|NCT01781481|144674312|SUPERIORITY_OR_OTHER||||||>|0.05||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Symptom Severity Item (Current/Biological) and Number of Surgeries"||||>0.05
72573754|NCT01781481|144674312|SUPERIORITY_OR_OTHER||||||>|0.05||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Symptom Severity Item (Current/Biological) and Number of Courses of Prednisone."||||>0.05
72573755|NCT01781481|144674312|SUPERIORITY_OR_OTHER||||||>|0.05||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Symptom Severity Item (Current/Biological) and Use of Immunomodulators."||||>0.05
72573756|NCT01781481|144674312|SUPERIORITY_OR_OTHER||||||>|0.05||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Symptom Severity Item (Current/Biological) and Use of anti-TNFa Medications."||||>0.05
72573757|NCT01781481|144674312|SUPERIORITY_OR_OTHER||||||>|0.05||||||The threshold for significance is p\<0.05. The P-Value indicated above was found for all the correlations which were examined.|Spearman Correlation Coefficient|||"Correlations between Pediatric INTERMED Diagnostic Dilemma Item (Historical Biological) and Functional Disability Index (Parent) and each of the following variables: Disease Severity at Diagnosis, Disease Severity at Interview, Functional Disability Index - Child, Functional Disability Index- Parent, Impact Quality of Life: General Well Being, Number of Surgeries, Number of Courses of Prednisone, Use of Immunomodulators, Use of Anti-TNFa Medications."||||>0.05
72626941|NCT00718315|144783102|SUPERIORITY_OR_OTHER|||||||0.179|||||||Chi-squared|||||||0.179
72369098|NCT04939415|144248210|SUPERIORITY||ratio of frequencies|0.14||||0.71|TWO_SIDED||||||Mixed Models Analysis||group by day interaction|||||0.710
72537686|NCT00315328|144605657|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.3|||||TWO_SIDED|95.0|0.4|2.2|||ANCOVA|||95% confidence interval constructed on the treatment group difference of mean change in fellow eye visual acuity from baseline to 17 weeks, adjusted for baseline fellow eye visual acuity.||2.2|0.4|
72537687|NCT00448630|144605659|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||P-value was not adjusted for multiple comparisons; p-values \< 0.05 were considered statistically significant.|Friedman|||We hypothesize that atypical antipsychotic therapy effects the metabolic syndrome parameters, particularly body mass index.||||<0.001
72537688|NCT00448630|144605660|SUPERIORITY_OR_OTHER_LEGACY|||||||0.49||95.0||||P-value was not adjusted for multiple comparisons; p-values \< 0.05 were considered statistically significant.|Friedman|||Friedman's test was used to assess trends over time.||||0.490
72537689|NCT00448630|144605660|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||P-value was not adjusted for multiple comparisons; p-values \< 0.05 were considered statistically significant.|Friedman|||Friedman's test was used to assess trends over time.||||<0.001
72537690|NCT00448630|144605660|SUPERIORITY_OR_OTHER_LEGACY|||||||0.006||95.0||||P-value was not adjusted for multiple comparisons; p-values \< 0.05 were considered statistically significant.|Friedman|||Friedman's test was used to assess trends over time.||||0.006
72537691|NCT00448630|144605660|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||P-value was not adjusted for multiple comparisons; p-values \< 0.05 were considered statistically significant.|Friedman|||Friedman's test was used to assess trends over time.||||<0.001
72573758|NCT01781481|144674312|SUPERIORITY_OR_OTHER||||||>|0.05||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Diagnostic/Therapeutic Challenge Item (Current Biological) and IBD Disease Severity at Diagnosis."||||>0.05
72573759|NCT01781481|144674312|SUPERIORITY_OR_OTHER||||||<|0.05||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Diagnostic/Therapeutic Challenge Item (Current Biological) and IBD Disease Severity at time of study participation."||||<0.05
72573760|NCT01781481|144674312|SUPERIORITY_OR_OTHER||||||<|0.05||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Diagnostic/Therapeutic Challenge Item (Current Biological) and Functional Disability Index (Child Rating)"||||<0.05
72573761|NCT01781481|144674312|SUPERIORITY_OR_OTHER||||||>|0.05||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Diagnostic/Therapeutic Challenge Item (Current Biological) and Functional Disability Index (parent rating)."||||>0.05
72626942|NCT00718315|144783103|SUPERIORITY_OR_OTHER|||||||0.066|||||||Kruskal-Wallis|||||||0.066
72626943|NCT00718315|144783104|SUPERIORITY_OR_OTHER|||||||0.087|||||||Kruskal-Wallis|||||||0.087
72369099|NCT04939415|144248211|SUPERIORITY||F value|2.855||||0.099|TWO_SIDED||||||Mixed Models Analysis||group by day interaction|||||0.099
72369100|NCT04939415|144248212|SUPERIORITY||F value|1.497||||0.228|TWO_SIDED||||||Mixed Models Analysis||group by day interaction|||||0.228
72369101|NCT04939415|144248213|SUPERIORITY||F value|2.537||||0.119|TWO_SIDED||||||Mixed Models Analysis||group by day interaction|||||0.119
72369102|NCT04939415|144248214|SUPERIORITY||F value|0.219||||0.643|TWO_SIDED||||||Mixed Models Analysis||group by day interaction|||||0.643
72537692|NCT00448630|144605660|SUPERIORITY_OR_OTHER_LEGACY|||||||0.003||95.0||||P-value was not adjusted for multiple comparisons; p-values \< 0.05 were considered statistically significant.|Friedman|||Friedman's test was used to assess trends over time.||||0.003
72537693|NCT00448630|144605660|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||P-value was not adjusted for multiple comparisons; p-values \< 0.05 were considered statistically significant.|Friedman|||Friedman's test was used to assess trends over time.||||<0.001
72537694|NCT00448630|144605660|SUPERIORITY_OR_OTHER_LEGACY|||||||0.05||95.0||||P-value was not adjusted for multiple comparisons; p-values \< 0.05 were considered statistically significant.|Friedman|||Friedman's test was used to assess trends over time.||||0.050
72537695|NCT00448630|144605660|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0012||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0012
72537696|NCT00448630|144605660|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0078||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0078
72537697|NCT00448630|144605660|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0001||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0001
72537698|NCT00448630|144605660|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0133||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0133
72537699|NCT00448630|144605660|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0142||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0142
72369103|NCT04939415|144248215|SUPERIORITY||F value|0.054||||0.817|TWO_SIDED||||||Mixed Models Analysis|||||||0.817
72537700|NCT00448630|144605660|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0265||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0265
72537701|NCT00448630|144605660|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1613||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.1613
72537702|NCT00448630|144605660|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2644||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.2644
72537703|NCT00448630|144605660|SUPERIORITY_OR_OTHER_LEGACY|||||||5e-06||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.000005
72537704|NCT00448630|144605660|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7385||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.7385
72537705|NCT00448630|144605660|SUPERIORITY_OR_OTHER_LEGACY|||||||1||95.0|||||Wilcoxon (Mann-Whitney)|||||||1.0000
72537706|NCT00448630|144605660|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6813||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.6813
72537707|NCT00448630|144605660|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0024||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0024
72537708|NCT00448630|144605660|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2237||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.2237
72537709|NCT00448630|144605660|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5774||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.5774
72537710|NCT00448630|144605660|SUPERIORITY_OR_OTHER_LEGACY|||||||1e-06||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.000001
72537711|NCT00448630|144605660|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2502||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.2502
72537712|NCT00448630|144605660|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5224||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.5224
72537713|NCT00448630|144605660|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0001||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0001
72537714|NCT00448630|144605660|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0002||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0002
72537715|NCT00448630|144605660|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8166||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.8166
72626944|NCT00718315|144783105|SUPERIORITY_OR_OTHER|||||||0.308|||||||Kruskal-Wallis|||||||0.308
72626945|NCT01128569|144783110|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.162|||||TWO_SIDED|95.0|0.087|0.237||||||||0.237|0.087|
72626946|NCT01128569|144783110|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.145|||||TWO_SIDED|95.0|0.069|0.222||||||||0.222|0.069|
72626947|NCT01128569|144783110|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.017|||||TWO_SIDED|95.0|-0.091|0.057||||||||0.057|-0.091|
72626948|NCT02519842|144783115|OTHER||Mean Difference (Final Values)|9.8|||||TWO_SIDED|95.0|-7.6|27.9|||||Mean difference in percentage of participants who experienced at least 1 tier 2 AE and received fosaprepitant regimen compared with participants who received control regimen.|||27.9|-7.6|
72626949|NCT02519842|144783116|OTHER||Mean Difference (Final Values)|5.4|||||TWO_SIDED|95.0|-5.1|17.8|||||Mean difference in percentage of participants who discontinued due to an AE and received fosaprepitant regimen compared with participants who received control regimen.|||17.8|-5.1|
72537716|NCT00448630|144605661|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||P-value was not adjusted for multiple comparisons; p-values \< 0.05 were considered statistically significant.|Friedman|||We hypothesize that atypical antipsychotic therapy effects the metabolic syndrome parameters, particularly body mass index.||||<0.001
72626950|NCT01977222|144783194|OTHER|||||||0.1673|||||||t-test, 2 sided|||||||0.1673
72537717|NCT00448630|144605662|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||P-value was not adjusted for multiple comparisons; p-values \< 0.05 were considered statistically significant.|Friedman|||Friedman's test was used to assess trends over time (Baseline, 1 month, 4 months).||||<0.001
72537718|NCT00448630|144605663|SUPERIORITY_OR_OTHER_LEGACY|||||||0.544||95.0||||P-value was not adjusted for multiple comparisons; p-values \< 0.05 were considered statistically significant.|Friedman|||Friedman's test was used to assess trends over time (Baseline, 1 month, 4 months).||||0.544
72626951|NCT01977222|144783195|OTHER|||||||0.5745|||||||t-test, 2 sided|||||||0.5745
72626952|NCT01977222|144783196|OTHER|||||||0.511|||||||t-test, 2 sided|||||||.511
72626953|NCT01977222|144783197|OTHER|||||||0.776|||||||t-test, 2 sided|||||||0.776
72626954|NCT01977222|144783198|OTHER|||||||0.5374|||||||t-test, 2 sided|||||||0.5374
72626955|NCT01977222|144783199|OTHER|||||||0.3385|||||||t-test, 2 sided|||||||0.3385
72626956|NCT01977222|144783200|OTHER|||||||0.0189|||||||t-test, 2 sided|||||||0.0189
72626957|NCT01977222|144783201|OTHER|||||||0.1183|||||||t-test, 2 sided|||||||0.1183
72369104|NCT04939415|144248216|SUPERIORITY||F value|0.315||||0.578|TWO_SIDED||||||Mixed Models Analysis||group by day interaction|||||0.578
72537719|NCT00448630|144605664|SUPERIORITY_OR_OTHER_LEGACY|||||||0.245||95.0||||P-value was not adjusted for multiple comparisons; p-values \< 0.05 were considered statistically significant.|Friedman|||Friedman's test was used to assess trends over time (Baseline, 1 month, 4 months).||||0.245
72537720|NCT00448630|144605665|SUPERIORITY_OR_OTHER_LEGACY|||||||0.362||95.0||||P-value was not adjusted for multiple comparisons; p-values \< 0.05 were considered statistically significant.|Friedman|||Friedman's test was used to assess trends over time (Baseline, 1 month, 4 months).||||0.362
72537721|NCT00448630|144605666|SUPERIORITY_OR_OTHER_LEGACY|||||||0.176||95.0||||P-value was not adjusted for multiple comparisons; p-values \< 0.05 were considered statistically significant.|Friedman|||Friedman's test was used to assess trends over time (Baseline, 1 month, 4 months).||||0.176
72537722|NCT00448630|144605667|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||P-value was not adjusted for multiple comparisons; p-values \< 0.05 were considered statistically significant.|Friedman|||Friedman's test was used to assess trends over time (Baseline, 1 month, 4 months).||||<0.001
72537723|NCT00448630|144605668|SUPERIORITY_OR_OTHER_LEGACY|||||||0.524||95.0||||P-value was not adjusted for multiple comparisons; p-values \< 0.05 were considered statistically significant.|Friedman|||Friedman's test was used to assess trends over time.||||0.524
72537724|NCT00448630|144605668|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||P-value was not adjusted for multiple comparisons; p-values \< 0.05 were considered statistically significant.|Friedman|||Friedman's test was used to assess trends over time.||||<0.001
72626958|NCT01605669|144783205|SUPERIORITY_OR_OTHER||Percentage Sensitivity|85.7||||||95.0||||||||||||
72626959|NCT01605669|144783205|SUPERIORITY_OR_OTHER||Percent Specificity|72.4||||||95.0||||||||||||
72626960|NCT01605669|144783205|SUPERIORITY_OR_OTHER||Percent Error Rate|25.0||||||95.0|||||||Error rate of 9/36 is equal to total of false positives plus false negatives over the total of participants analyzed.|||||
72626961|NCT04846231|144783209|SUPERIORITY||Mean Difference (Net)|35.22|||<|0.001|TWO_SIDED|95.0|29.13|41.32|||ANCOVA|||To control the overall alpha of the study, the primary endpoint will be evaluated hierarchically. Each comparison to rosuvastatin will use an alpha of 0.05. This belongs to the primary endpoint.||41.32|29.13|<0.001
72626962|NCT04846231|144783209|SUPERIORITY||Mean Difference (Net)|34.43|||<|0.001|TWO_SIDED|95.0|28.28|40.58|||ANCOVA|||To control the overall alpha of the study, the primary endpoint will be evaluated hierarchically. Each comparison to rosuvastatin will use an alpha of 0.05.||40.58|28.28|<0.001
72626963|NCT04846231|144783209|SUPERIORITY||Mean Difference (Net)|38.27|||<|0.001|TWO_SIDED|95.0|32.2|44.34|||ANCOVA|||To control the overall alpha of the study, the primary endpoint will be evaluated hierarchically. Each comparison to rosuvastatin will use an alpha of 0.05.||44.34|32.20|<0.001
72626964|NCT04846231|144783209|SUPERIORITY||Mean Difference (Net)|42.98|||<|0.001|TWO_SIDED|95.0|37.02|48.95|||ANCOVA|||To control the overall alpha of the study, the primary endpoint will be evaluated hierarchically. Each comparison to rosuvastatin will use an alpha of 0.05.||48.95|37.02|<0.001
72626965|NCT04846231|144783209|SUPERIORITY||Mean Difference (Final Values)|36.57|||<|0.001|TWO_SIDED|95.0|30.61|42.54|||ANCOVA|||To control the overall alpha of the study, the primary endpoint will be evaluated hierarchically. Each comparison to rosuvastatin will use an alpha of 0.05.||42.54|30.61|<0.001
72626966|NCT04846231|144783209|SUPERIORITY||Mean Difference (Net)|33.49|||<|0.001|TWO_SIDED|95.0|27.42|39.55|||ANCOVA|||To control the overall alpha of the study, the primary endpoint will be evaluated hierarchically. Each comparison to rosuvastatin will use an alpha of 0.05.||39.55|27.42|<0.001
72626967|NCT04846231|144783209|SUPERIORITY||Mean Difference (Net)|31.31|||<|0.001|TWO_SIDED|95.0|25.16|37.47|||ANCOVA|||To control the overall alpha of the study, the primary endpoint will be evaluated hierarchically. Each comparison to rosuvastatin will use an alpha of 0.05.||37.47|25.16|<0.001
72626968|NCT04846231|144783211|SUPERIORITY|||||||0.05|||||||ANCOVA|||||||0.05
72626969|NCT00945659|144783217|SUPERIORITY||Mean Difference (Net)|-0.003|STANDARD_DEVIATION|0.2||0.86|TWO_SIDED|95.0|-0.43|0.36|||Generalized Estimating Equation|||||0.36|-0.43|0.86
72537725|NCT00448630|144605668|SUPERIORITY_OR_OTHER_LEGACY|||||||0.005||95.0||||P-value was not adjusted for multiple comparisons; p-values \< 0.05 were considered statistically significant.|Friedman|||Friedman's test was used to assess trends over time.||||0.005
72537726|NCT00448630|144605668|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||P-value was not adjusted for multiple comparisons; p-values \< 0.05 were considered statistically significant.|Friedman|||Friedman's test was used to assess trends over time.||||<0.001
72537727|NCT00448630|144605668|SUPERIORITY_OR_OTHER_LEGACY|||||||0.009||95.0||||P-value was not adjusted for multiple comparisons; p-values \< 0.05 were considered statistically significant.|Friedman|||Friedman's test was used to assess trends over time.||||0.009
72537728|NCT00448630|144605668|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||P-value was not adjusted for multiple comparisons; p-values \< 0.05 were considered statistically significant.|Friedman|||Friedman's test was used to assess trends over time.||||<0.001
72626970|NCT00945659|144783217|SUPERIORITY||Mean Difference (Net)|-0.41|STANDARD_ERROR_OF_MEAN|0.19||0.03|TWO_SIDED|95.0|-0.78|-0.04|||Generalized Estimating Equation|||||-0.04|-0.78|0.03
72537729|NCT00448630|144605668|SUPERIORITY_OR_OTHER_LEGACY|||||||0.047||95.0||||P-value was not adjusted for multiple comparisons; p-values \< 0.05 were considered statistically significant.|Friedman|||Friedman's test was used to assess trends over time.||||0.047
72537730|NCT00448630|144605668|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0007||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0007
72537731|NCT00448630|144605668|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0057||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0057
72537732|NCT00448630|144605668|SUPERIORITY_OR_OTHER_LEGACY|||||||9e-05||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.00009
72537733|NCT00448630|144605668|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0201||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0201
72537734|NCT00448630|144605668|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0095||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0095
72369105|NCT04939415|144248217|SUPERIORITY||F value|0.215||||0.643|TWO_SIDED||||||Mixed Models Analysis||day by group interaction|||||.643
72537735|NCT00448630|144605668|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0386||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0386
72537736|NCT00448630|144605668|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1976||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.1976
72537737|NCT00448630|144605668|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2383||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.2383
72537738|NCT00448630|144605668|SUPERIORITY_OR_OTHER_LEGACY|||||||2e-05||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.00002
72537739|NCT00448630|144605668|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8297||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.8297
72369106|NCT04939415|144248218|SUPERIORITY||F value|1.987||||0.159|TWO_SIDED||||||Mixed Models Analysis||day by group interaction|||||.159
72537740|NCT00448630|144605668|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9081||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.9081
72537741|NCT00448630|144605668|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7386||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.7386
72537742|NCT00448630|144605668|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0024||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0024
72537743|NCT00448630|144605668|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2587||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.2587
72537744|NCT00448630|144605668|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6263||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.6263
72537745|NCT00448630|144605668|SUPERIORITY_OR_OTHER_LEGACY|||||||1e-06||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.000001
72537746|NCT00448630|144605668|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2589||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.2589
72537747|NCT00448630|144605668|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5153||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.5153
72537748|NCT00448630|144605668|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0003||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0003
72537749|NCT00448630|144605668|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0005||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0005
72537750|NCT00448630|144605668|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8952||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.8952
72537751|NCT00448630|144605669|SUPERIORITY_OR_OTHER_LEGACY|||||||0.197||95.0||||P-value was not adjusted for multiple comparisons; p-values \< 0.05 were considered statistically significant.|Friedman|||Friedman's test was used to assess trends over time.||||0.197
72537752|NCT00448630|144605669|SUPERIORITY_OR_OTHER_LEGACY|||||||0.01||95.0||||P-value was not adjusted for multiple comparisons; p-values \< 0.05 were considered statistically significant.|Friedman|||Friedman's test was used to assess trends over time.||||0.010
72537753|NCT00448630|144605669|SUPERIORITY_OR_OTHER_LEGACY|||||||0.012||95.0||||P-value was not adjusted for multiple comparisons; p-values \< 0.05 were considered statistically significant.|Friedman|||Friedman's test was used to assess trends over time.||||0.012
72537754|NCT00448630|144605669|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||P-value was not adjusted for multiple comparisons; p-values \< 0.05 were considered statistically significant.|Friedman|||Friedman's test was used to assess trends over time.||||<0.001
72537755|NCT00448630|144605669|SUPERIORITY_OR_OTHER_LEGACY|||||||0.282||95.0||||P-value was not adjusted for multiple comparisons; p-values \< 0.05 were considered statistically significant.|Friedman|||Friedman's test was used to assess trends over time.||||0.282
72537756|NCT00448630|144605669|SUPERIORITY_OR_OTHER_LEGACY|||||||0.04||95.0||||P-value was not adjusted for multiple comparisons; p-values \< 0.05 were considered statistically significant.|Friedman|||Friedman's test was used to assess trends over time.||||0.040
72537757|NCT00448630|144605669|SUPERIORITY_OR_OTHER_LEGACY|||||||0.004||95.0||||P-value was not adjusted for multiple comparisons; p-values \< 0.05 were considered statistically significant.|Friedman|||Friedman's test was used to assess trends over time.||||0.004
72537758|NCT00448630|144605669|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0193||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0193
72537759|NCT00448630|144605669|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0065||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0065
72537760|NCT00448630|144605669|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0002||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0002
72537761|NCT00448630|144605669|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3172||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.3172
72537762|NCT00448630|144605669|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0116||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0116
72537763|NCT00448630|144605669|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0016||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0016
72537764|NCT00448630|144605669|SUPERIORITY_OR_OTHER_LEGACY|||||||0.26||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.2600
72626971|NCT00945659|144783218|SUPERIORITY||Mean Difference (Net)|-10.05|STANDARD_DEVIATION|4.72||0.03|TWO_SIDED|95.0|-19.3|-0.81|||Generalized Estimating Equation|||||-0.81|-19.30|0.03
72626972|NCT00945659|144783218|SUPERIORITY||Mean Difference (Net)|-0.82|STANDARD_DEVIATION|5.47||0.88|TWO_SIDED|95.0|-11.54|9.9|||Generalized Estimating Equation|||||9.9|-11.54|0.88
72537765|NCT00448630|144605669|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2309||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.2309
72573762|NCT01781481|144674312|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Diagnostic/Therapeutic Challenge Item (Current Biological) and Impact Quality of LIfe: General Well-Being Scale"||||<0.01
72626973|NCT00945659|144783219|SUPERIORITY||Generalized Estimating Equation|-3.45|STANDARD_DEVIATION|4.98||0.49|TWO_SIDED|95.0|-13.21|6.32|||Generalized Estimating Equation|||||6.32|-13.21|0.49
72626974|NCT00945659|144783219|SUPERIORITY||Mean Difference (Net)|2.53|STANDARD_DEVIATION|5.76||0.66|TWO_SIDED|95.0|||||Generalized Estimating Equation|||||||0.66
72537766|NCT00448630|144605669|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0063||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0063
72537767|NCT00448630|144605669|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8158||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.8158
72537768|NCT00448630|144605669|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3968||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.3968
72537769|NCT00448630|144605669|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7193||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.7193
72537770|NCT00448630|144605669|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0127||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0127
72537771|NCT00448630|144605669|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2351||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.2351
72573763|NCT01781481|144674312|SUPERIORITY_OR_OTHER||||||>|0.05||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Diagnostic/Therapeutic Challenge Item (Current Biological) and Number of Surgeries."||||>0.05
72537772|NCT00448630|144605669|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5672||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.5672
72537773|NCT00448630|144605669|SUPERIORITY_OR_OTHER_LEGACY|||||||9e-05|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||0.00009
72537774|NCT00448630|144605669|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1774||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.1774
72537775|NCT00448630|144605669|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6082||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.6082
72573764|NCT01781481|144674312|SUPERIORITY_OR_OTHER||||||>|0.05||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Diagnostic/Therapeutic Challenge Item (Current Biological) and Number of Courses of Prednisone."||||>0.05
72573765|NCT01781481|144674312|SUPERIORITY_OR_OTHER||||||>|0.05||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Diagnostic/Therapeutic Challenge Item (Current Biological) and Use of Immunomodulators. ."||||>0.05
72573766|NCT01781481|144674312|SUPERIORITY_OR_OTHER||||||>|0.05||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Diagnostic/Therapeutic Challenge Item (Current Biological) and Use of anti-TNFa Medications"||||>0.05
72626975|NCT00945659|144783220|SUPERIORITY||Mean Difference (Net)|0.4|STANDARD_DEVIATION|0.86||0.64|TWO_SIDED|95.0|-1.29|2.08|||Generalized Estimating Equation|||||2.08|-1.29|0.64
72626976|NCT00945659|144783220|SUPERIORITY||Mean Difference (Net)|-0.41|STANDARD_DEVIATION|0.92||0.65|TWO_SIDED|95.0|-2.22|1.39|||Generalized Estimating Equation|||||1.39|-2.22|0.65
72626977|NCT00945659|144783221|SUPERIORITY||Mean Difference (Net)|0.71|STANDARD_DEVIATION|63.4||0.99|TWO_SIDED|95.0|-123.56|124.97|||Generalized Estimating Equation|||||124.97|-123.56|0.99
72537776|NCT00448630|144605669|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0079||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0079
72537777|NCT00448630|144605669|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0014||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0014
72537778|NCT00448630|144605669|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5587||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.5587
72537779|NCT00448630|144605670|SUPERIORITY_OR_OTHER_LEGACY|||||||0.077||95.0||||P-value was not adjusted for multiple comparisons; p-values \< 0.05 were considered statistically significant.|Friedman|||Friedman's test was used to assess trends over time.||||0.077
72537780|NCT00448630|144605670|SUPERIORITY_OR_OTHER_LEGACY|||||||0.039||95.0||||P-value was not adjusted for multiple comparisons; p-values \< 0.05 were considered statistically significant.|Friedman|||Friedman's test was used to assess trends over time.||||0.039
72537781|NCT00448630|144605670|SUPERIORITY_OR_OTHER_LEGACY|||||||0.978||95.0||||P-value was not adjusted for multiple comparisons; p-values \< 0.05 were considered statistically significant.|Friedman|||Friedman's test was used to assess trends over time.||||0.978
72537782|NCT00448630|144605670|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||P-value was not adjusted for multiple comparisons; p-values \< 0.05 were considered statistically significant.|Friedman|||Friedman's test was used to assess trends over time.||||<0.001
72537783|NCT00448630|144605670|SUPERIORITY_OR_OTHER_LEGACY|||||||0.593||95.0||||P-value was not adjusted for multiple comparisons; p-values \< 0.05 were considered statistically significant.|Friedman|||Friedman's test was used to assess trends over time.||||0.593
72537784|NCT00448630|144605670|SUPERIORITY_OR_OTHER_LEGACY|||||||0.987||95.0||||P-value was not adjusted for multiple comparisons; p-values \< 0.05 were considered statistically significant.|Friedman|||Friedman's test was used to assess trends over time.||||0.987
72537785|NCT00448630|144605670|SUPERIORITY_OR_OTHER_LEGACY|||||||0.174||95.0||||P-value was not adjusted for multiple comparisons; p-values \< 0.05 were considered statistically significant.|Friedman|||Friedman's test was used to assess trends over time.||||0.174
72537786|NCT00468312|144605671|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||ANCOVA|Analysis of covariance (ANCOVA) extracted sources of variation due to treatment, variable specific baseline, and site.||||||<0.001
72537787|NCT00468312|144605672|SUPERIORITY_OR_OTHER_LEGACY|||||||0.026||95.0|||||ANCOVA|Analysis of covariance (ANCOVA) extracted sources of variation due to treatment, variable specific baseline, and site.||||||0.026
72537788|NCT00468312|144605673|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||ANCOVA|Analysis of covariance (ANCOVA) extracted sources of variation due to treatment, variable specific baseline, and site.||||||<0.001
72537789|NCT00468312|144605674|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||ANCOVA|Analysis of covariance (ANCOVA) extracted sources of variation due to treatment, variable specific baseline, and site.||||||<0.001
72537790|NCT00468312|144605675|SUPERIORITY_OR_OTHER_LEGACY|||||||0.269||95.0|||||ANCOVA|Analysis of covariance (ANCOVA) extracted sources of variation due to treatment, variable specific baseline, and site.||||||0.269
72537791|NCT01052038|144605676|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Kruskal-Wallis|||||||<0.001
72537792|NCT01052038|144605676|SUPERIORITY_OR_OTHER||Median Difference (Net)|1.0|||<|0.001|TWO_SIDED|95.0|0.0|2.0|||Wilcoxon (Mann-Whitney)|||||2|0|<0.001
72537793|NCT01052038|144605676|SUPERIORITY_OR_OTHER||Median Difference (Net)|1.0|||<|0.001|TWO_SIDED|95.0|0.0|2.0|||Wilcoxon (Mann-Whitney)|||||2|0|<0.001
72537794|NCT01052038|144605677|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Kruskal-Wallis|Dunn's post hoc-test corrected for 12 comparisons.||||||<0.001
72537795|NCT01052038|144605677|SUPERIORITY_OR_OTHER||Median Difference (Net)|22.0||||0.005|TWO_SIDED|95.0|14.0|29.0|||Wilcoxon (Mann-Whitney)|||||29|14|0.005
72537796|NCT01052038|144605677|SUPERIORITY_OR_OTHER||Median Difference (Net)|14.0||||0.004|TWO_SIDED|95.0|7.0|22.0|||Wilcoxon (Mann-Whitney)|||||22|7|0.004
72537797|NCT01052038|144605678|SUPERIORITY_OR_OTHER|||||||0.004||95.0|||||Chi-squared, Corrected|||||||0.004
72537798|NCT01052038|144605679|SUPERIORITY_OR_OTHER|||||||0.01||95.0|||||Kruskal-Wallis|Post hoc test using Dunn's test corrected for 12 comparisons||||||0.01
72537799|NCT01052038|144605679|SUPERIORITY_OR_OTHER||Median Difference (Net)|10.0||||0.003||95.0|0.0|20.0|||Wilcoxon (Mann-Whitney)|||||20|0|0.003
72537800|NCT01052038|144605680|SUPERIORITY_OR_OTHER|||||||0.04||95.0|||||Chi-squared, Corrected|||||||0.04
72537801|NCT04253756|144605694|NON_INFERIORITY|The margin of non-inferiority (Delta) was 5g/dl|Mean Difference (Final Values)|0.5||||0.87|TWO_SIDED||||||ANOVA|||||||0.87
72537802|NCT04253756|144605695|NON_INFERIORITY|The non-inferiority margin (Delta) was 10 minutes of run time, no other key parameters|Mean Difference (Final Values)|3.2||||0.32|TWO_SIDED||||||ANOVA|||||||0.32
72537803|NCT02367729|144605700|SUPERIORITY||Mean Difference (Final Values)|2.15|STANDARD_ERROR_OF_MEAN|0.3947||0.003|TWO_SIDED|95.0|1.37|2.93|||Wilcoxon (Mann-Whitney)|||||2.93|1.37|0.003
72537804|NCT00759174|144605708|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.15||||0.033|TWO_SIDED|95.0|1.06|4.34|||Conditional logistic regression|||Conditional logistic regression was stratified by participant.||4.34|1.06|0.033
72537805|NCT00759174|144605709|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.36||||0.003|TWO_SIDED|95.0|1.33|4.19|||Conditional logistic regression|||Conditional logistic regression was stratified by participant.||4.19|1.33|0.003
72537806|NCT00759174|144605710|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|3.61|||<|0.001|TWO_SIDED|95.0|1.7|7.69|||Conditional logistic regression|||Conditional logistic regression was stratified by participant.||7.69|1.70|<0.001
72537807|NCT01890109|144605711|SUPERIORITY||Least Square Geometric Mean Ratio|1.1||||0.723|TWO_SIDED|95.0|0.66|1.83|||Repeated Measures Analysis of Covariance|||Repeated measures analysis of covariance was performed on the log transformed ratio to baseline of the number of daily moderate to severe hot flashes. Independent variables included treatment, week, and the treatment-by-week interaction; subject served as a random effect; and the log transformed baseline number of daily moderate to severe hot flashes was used as a covariate.||1.83|0.66|0.723
72573767|NCT01781481|144674312|SUPERIORITY_OR_OTHER||||||>|0.05||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Therapeutic Complexity Item (Current Biological) and Disease Severity at Diagnosis."||||>0.05
72573768|NCT01781481|144674312|SUPERIORITY_OR_OTHER||||||>|0.05||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Therapeutic Complexity Item (Current Biological) and Disease Severity at time of study participation (Pediatric INTERMED interview)."||||>0.05
72573769|NCT01781481|144674312|SUPERIORITY_OR_OTHER||||||>|0.05||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Therapeutic Complexity Item (Current Biological) and Functional Disability Index (Child Rating)."||||>0.05
72573770|NCT01781481|144674312|SUPERIORITY_OR_OTHER||||||>|0.05||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Therapeutic Complexity Item (Current Biological) and Functional Disability Index (Parent Rating)"||||>0.05
72573771|NCT01781481|144674312|SUPERIORITY_OR_OTHER||||||>|0.05||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Therapeutic Complexity Item (Current Biological) and Impact Quality of Life: General Well-Being"||||>0.05
72573772|NCT01781481|144674312|SUPERIORITY_OR_OTHER||||||>|0.05||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Therapeutic Complexity Item (Current Biological) and Number of Surgeries."||||>0.05
72573773|NCT01781481|144674312|SUPERIORITY_OR_OTHER||||||<|0.05||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Therapeutic Complexity Item (Current Biological) and Number of Courses of Prednisone since diagnosis."||||<0.05
72537808|NCT01890109|144605712|SUPERIORITY||Least Square Geometric Mean Ratio|1.14||||0.551|TWO_SIDED|95.0|0.74|1.74|||Repeated Measures Analysis of Covariance|||Repeated measures analysis of covariance was performed on the log transformed ratio to baseline of the daily hot flash severity score. Independent variables included treatment, week, and the treatment-by-week interaction; subject served as a random effect; and the log transformed baseline daily hot flash severity score was used as a covariate.||1.74|0.74|0.551
72537809|NCT03692078|144605782|EQUIVALENCE|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 1 is equal to zero on Day 5.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 1 is NOT equal to zero on Day 5. (mITT Population)"|Mean Difference (Net)|6.116|||<|0.0001|TWO_SIDED|95.0|5.976|6.255|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 1 is equal to zero on Day 5.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 1 is NOT equal to zero on Day 5. (mITT Population)"||6.255|5.976|<.0001
72537810|NCT03692078|144605782|EQUIVALENCE|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 1 is equal to zero on Day 7.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 1 is NOT equal to zero on Day 7. (mITT Population)"|Mean Difference (Net)|6.073|||<|0.0001|TWO_SIDED|95.0|5.963|6.183|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 1 is equal to zero on Day 7.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 1 is NOT equal to zero on Day 7. (mITT Population)"||6.183|5.963|<.0001
72537811|NCT03692078|144605782|EQUIVALENCE|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 2 is equal to zero on Day 5.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 2 is NOT equal to zero on Day 5. (mITT Population)"|Mean Difference (Net)|5.736|||<|0.0001|TWO_SIDED|95.0|5.605|5.868|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 2 is equal to zero on Day 5.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 2 is NOT equal to zero on Day 5. (mITT Population)"||5.868|5.605|<.0001
72573774|NCT01781481|144674312|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significiance is p\<0.01.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Therapeutic Complexity Item (Current Biological) and Use of Immunomodulators (azathioprine or methotrexate)."||||<0.01
72573775|NCT01781481|144674312|SUPERIORITY_OR_OTHER||||||<|0.01||||||The Threshold for significance is p\<0.05)|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Therapeutic Complexity Item (Current Biological) and Use of ant-TNFa Medications (infliximab or adalimumab)."||||<0.01
72573776|NCT01781481|144674312|SUPERIORITY_OR_OTHER||||||>|0.05||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Complications and Life Threat Item (Vulnerability Biological) and Disease Severity at diagnosis."||||>0.05
72573777|NCT01781481|144674312|SUPERIORITY_OR_OTHER||||||<|0.05||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Complications and Life Threat Item (Vulnerability Biological) and Disease Severity at study participation."||||<0.05
72573778|NCT01781481|144674312|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Complications and Life Threat Item (Vulnerability Biological) and Functional Disability Index (Child Rating)."||||<0.01
72573779|NCT01781481|144674312|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\<0.01.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Complications and Life Threat Item (Vulnerability Biological) and Functional Disability Index (parent rating)."||||<0.01
72626978|NCT00945659|144783221|SUPERIORITY||Mean Difference (Net)|-1.22|STANDARD_DEVIATION|13.81||0.93|TWO_SIDED|95.0|-28.26|25.83|||Generalized Estimating Equation|||||25.83|-28.26|0.93
72537812|NCT03692078|144605782|EQUIVALENCE|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 2 is equal to zero on Day 7.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 2 is NOT equal to zero on Day 7. (mITT Population)"|Mean Difference (Net)|5.792|||<|0.0001|TWO_SIDED|95.0|5.687|5.897|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 2 is equal to zero on Day 7.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 2 is NOT equal to zero on Day 7. (mITT Population)"||5.897|5.687|<.0001
72537813|NCT03692078|144605782|EQUIVALENCE|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 3 is equal to zero on Day 5.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 3 is NOT equal to zero on Day 5. (mITT Population)"|Mean Difference (Net)|5.835|||<|0.0001|TWO_SIDED|95.0|5.701|5.969|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 3 is equal to zero on Day 5.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 3 is NOT equal to zero on Day 5. (mITT Population)"||5.969|5.701|<.0001
72537814|NCT03692078|144605782|EQUIVALENCE|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 3 is equal to zero on Day 7.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 3 is NOT equal to zero on Day 7. (mITT Population)"|Mean Difference (Net)|5.799|||<|0.0001|TWO_SIDED|95.0|5.694|5.904|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 3 is equal to zero on Day 7.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 3 is NOT equal to zero on Day 7. (mITT Population)"||5.904|5.694|<.0001
72537815|NCT03692078|144605782|EQUIVALENCE|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 4 is equal to zero on Day 5.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 4 is NOT equal to zero on Day 5. (mITT Population)"|Mean Difference (Net)|4.881|||<|0.0001|TWO_SIDED|95.0|4.713|5.048|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 4 is equal to zero on Day 5.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 4 is NOT equal to zero on Day 5. (mITT Population)"||5.048|4.713|<.0001
72537816|NCT03692078|144605782|EQUIVALENCE|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 4 is equal to zero on Day 7.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 4 is NOT equal to zero on Day 7. (mITT Population)"|Mean Difference (Net)|4.844|||<|0.0001|TWO_SIDED|95.0|4.711|4.977|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 4 is equal to zero on Day 7.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 4 is NOT equal to zero on Day 7. (mITT Population)"||4.977|4.711|<.0001
72537817|NCT03692078|144605782|EQUIVALENCE|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 5 is equal to zero on Day 5.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 5 is NOT equal to zero on Day 5. (mITT Population)"|Mean Difference (Net)|5.185|||<|0.0001|TWO_SIDED|95.0|5.021|5.35|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 5 is equal to zero on Day 5.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 5 is NOT equal to zero on Day 5. (mITT Population)"||5.350|5.021|<.0001
72409182|NCT04154631|144326819|SUPERIORITY||Coefficient of indirect effect|-2.51||||0.02|TWO_SIDED|95.0|-4.58|-0.44|||SEM|||Structural equation modeling (SEM) was used to test whether the relationship between TranS-C condition (Immediate vs. UC-DT) and psychiatric symptoms (Diagnostic and Statistical Manual of Mental Disorders Cross-Cutting Symptom Measure) at post was mediated by sleep-related impairment (PROMIS-SRI) at post. The parameter of interest was the indirect effect.||-0.44|-4.58|0.02
72537818|NCT03692078|144605782|EQUIVALENCE|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 5 is equal to zero on Day 7.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 5 is NOT equal to zero on Day 7. (mITT Population)"|Mean Difference (Net)|4.933|||<|0.0001|TWO_SIDED|95.0|4.801|5.066|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 5 is equal to zero on Day 7.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 5 is NOT equal to zero on Day 7. (mITT Population)"||5.066|4.801|<.0001
72537819|NCT03692078|144605782|EQUIVALENCE|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 6 is equal to zero on Day 5.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 6 is NOT equal to zero on Day 5. (mITT Population)"|Mean Difference (Net)|5.014|||<|0.0001|TWO_SIDED|95.0|4.852|5.175|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 6 is equal to zero on Day 5.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 6 is NOT equal to zero on Day 5. (mITT Population)"||5.175|4.852|<.0001
72537820|NCT03692078|144605782|EQUIVALENCE|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 6 is equal to zero on Day 7.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 6 is NOT equal to zero on Day 7. (mITT Population)"|Mean Difference (Net)|4.892|||<|0.0001|TWO_SIDED|95.0|4.763|5.02|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 6 is equal to zero on Day 7.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 6 is NOT equal to zero on Day 7. (mITT Population)"||5.020|4.763|<.0001
72537821|NCT03692078|144605782|EQUIVALENCE|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 2 is equal to Group 1 on Day 5.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 2 is NOT equal to Group 1 on Day 5. (mITT Population)"|Mean Difference (Net)|-0.379||||0.0013|TWO_SIDED|95.0|-0.646|-0.112|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 2 is equal to Group 1 on Day 5.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 2 is NOT equal to Group 1 on Day 5. (mITT Population)"||-0.112|-0.646|0.0013
72537822|NCT03692078|144605782|EQUIVALENCE|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 2 is equal to Group 1 on Day 7.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 2 is NOT equal to Group 1 on Day 7. (mITT Population)"|Mean Difference (Net)|-0.281||||0.0034|TWO_SIDED|95.0|-0.496|-0.065|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 2 is equal to Group 1 on Day 7.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 2 is NOT equal to Group 1 on Day 7. (mITT Population)"||-0.065|-0.496|0.0034
72573780|NCT01781481|144674312|SUPERIORITY_OR_OTHER||||||<|0.05||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Complications and Life Threat Item (Vulnerability Biological) and Impact Quality of Life: General Well Being Scale."||||<0.05
72573781|NCT01781481|144674312|SUPERIORITY_OR_OTHER||||||>|0.05||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Complications and Life Threat Item (Vulnerability Biological) and Number of Surgeries."||||>0.05
72573782|NCT01781481|144674312|SUPERIORITY_OR_OTHER||||||>|0.05||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Complications and Life Threat Item (Vulnerability Biological) and Number of Courses of Prednisone."||||>0.05
72573783|NCT01781481|144674312|SUPERIORITY_OR_OTHER||||||<|0.05||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Complications and Life Threat Item (Vulnerability Biological) and Use of Immunomodulators (azathioprine or methotrexate)."||||<0.05
72573784|NCT01781481|144674312|SUPERIORITY_OR_OTHER||||||>|0.05||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Complications and Life Threat Item (Vulnerability Biological) and Use of anti-TNFa Medications."||||>0.05
72573785|NCT01781481|144674313|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\<0.05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Psychological Domain Score (psychological needs) and Internalizing Problems (Child Behaviour Checklist).||||<0.01
72573786|NCT01781481|144674313|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\<0.05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Psychological Domain Score (psychological needs) and Externalizing Problems (Child Behaviour Checklist).||||<0.01
72573787|NCT01781481|144674313|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\<0.05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Psychological Domain Score (psychological needs) and Children's Depression Inventory: Total Score||||<0.01
72573788|NCT01781481|144674313|SUPERIORITY_OR_OTHER||||||<|0.05||||||The threshold for significance is p\<0.05|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Psychological Domain Score (psychological needs) and Multidimensional Anxiety Scale for Children: Total Score.||||<0.05
72573789|NCT01781481|144674313|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\<0.05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Psychological Domain Score (psychological needs) and Impact Quality of Life: Emotional Scale||||<0.01
72409183|NCT04154631|144326819|SUPERIORITY||Coefficient of indirect effect|0.05||||0.97|TWO_SIDED|95.0|-1.99|2.08|||SEM|||Structural equation modeling (SEM) was used to test whether the relationship between treatment condition (Standard vs. Adapted) and functional impairment (The Diagnostic and Statistical Manual of Mental Disorders Cross-Cutting Symptom Measure) at post was mediated by provider ratings of acceptability (AIM) at post. The parameter of interest was the indirect effect.||2.08|-1.99|0.97
72409184|NCT04154631|144326819|SUPERIORITY||Coefficient of indirect effect|0.004||||0.97|TWO_SIDED|95.0|-0.18|0.19|||SEM|||Structural equation modeling (SEM) was used to test whether the relationship between treatment condition (Standard vs. Adapted) and functional impairment (The Diagnostic and Statistical Manual of Mental Disorders Cross-Cutting Symptom Measure) at 6-month follow-up was mediated by provider ratings of acceptability (AIM) at post. The parameter of interest was the indirect effect.||0.19|-0.18|0.97
72409185|NCT04154631|144326819|SUPERIORITY||Coefficient of indirect effect|0.02||||0.9|TWO_SIDED|95.0|-0.27|0.3|||SEM|||Structural equation modeling (SEM) was used to test whether the relationship between treatment condition (Standard vs. Adapted) and functional impairment (The Diagnostic and Statistical Manual of Mental Disorders Cross-Cutting Symptom Measure) at post was mediated by provider ratings of appropriateness (IAM) at post. The parameter of interest was the indirect effect.||0.30|-0.27|0.90
72409186|NCT04154631|144326819|SUPERIORITY||Coefficient of indirect effect|0.01||||0.94|TWO_SIDED|95.0|-0.19|0.2|||SEM|||Structural equation modeling (SEM) was used to test whether the relationship between treatment condition (Standard vs. Adapted) and functional impairment (The Diagnostic and Statistical Manual of Mental Disorders Cross-Cutting Symptom Measure) at 6-month follow-up was mediated by provider ratings of appropriateness (IAM) at post. The parameter of interest was the indirect effect.||0.20|-0.19|0.94
72537823|NCT03692078|144605782|EQUIVALENCE|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 3 is equal to Group 1 on Day 5.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 3 is NOT equal to Group 1 on Day 5. (mITT Population)"|Mean Difference (Net)|-0.281||||0.0354|TWO_SIDED|95.0|-0.549|-0.012|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 3 is equal to Group 1 on Day 5.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 3 is NOT equal to Group 1 on Day 5. (mITT Population)"||-0.012|-0.549|0.0354
72573790|NCT01781481|144674313|SUPERIORITY_OR_OTHER|||||||0.01||||||The threshold for significance is p\<0.05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Psychological Domain Score (psychological needs) and Social Competence Scale (Child Behaviour Checklist).||||0.01
72573791|NCT01781481|144674313|SUPERIORITY_OR_OTHER||||||<|0.05||||||The threshold for significance is p\<0.05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Psychological Domain Score (psychological needs) and Activities Competence Scale (Child Behaviour Checklist).||||<0.05
72573792|NCT01781481|144674313|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\<0.05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Psychological Domain Score (psychological needs) and Academic Competence Scale (Child Behaviour Checklist).||||<0.01
72626979|NCT00945659|144783222|SUPERIORITY||Mean Difference (Net)|1.17|STANDARD_DEVIATION|1.47||0.43|TWO_SIDED|95.0|-1.7|4.04|||Generalized Estimating Equation|||||4.04|-1.70|0.43
72626980|NCT00945659|144783222|SUPERIORITY||Mean Difference (Net)|-2.59|STANDARD_DEVIATION|1.87||0.08|TWO_SIDED|95.0|-5.5|0.32|||Generalized Estimating Equation|||||0.32|-5.50|0.08
72626981|NCT00945659|144783223|SUPERIORITY||Mean Difference (Net)|1.32|STANDARD_DEVIATION|1.66||0.43|TWO_SIDED|95.0|-1.94|4.56|||Generalized Estimating Equation|||||4.56|-1.94|0.43
72409187|NCT04154631|144326819|SUPERIORITY||Coefficient of indirect effect|-0.19||||0.8|TWO_SIDED|95.0|-1.67|1.28|||SEM|||Structural equation modeling (SEM) was used to test whether the relationship between treatment condition (Standard vs. Adapted) and functional impairment (The Diagnostic and Statistical Manual of Mental Disorders Cross-Cutting Symptom Measure) at post was mediated by provider ratings of feasibility (FIM) at post. The parameter of interest was the indirect effect.||1.28|-1.67|0.80
72409188|NCT04154631|144326819|SUPERIORITY||Coefficient of indirect effect|-0.04||||0.77|TWO_SIDED|95.0|-0.33|0.25|||SEM|||Structural equation modeling (SEM) was used to test whether the relationship between treatment condition (Standard vs. Adapted) and functional impairment (The Diagnostic and Statistical Manual of Mental Disorders Cross-Cutting Symptom Measure) at 6-month follow-up was mediated by provider ratings of feasibility (FIM) at post. The parameter of interest was the indirect effect.||0.25|-0.33|0.77
72409189|NCT04154631|144326820|SUPERIORITY||time by treatment interaction coeff.|-0.01||||0.94|TWO_SIDED||||||Intent-to-treat, multilevel modeling|||Treatment effect (Standard versus Adapted TranS-C) on change in Intervention Appropriateness Measure (IAM) from baseline (post-training) to post-treatment.||||0.94
72409190|NCT04154631|144326821|SUPERIORITY||Time by treatment interaction coeff.|-0.11||||0.34|TWO_SIDED||||||Intent-to-treat, multilevel modeling|||Treatment effect (Standard versus Adapted TranS-C) on change in Feasibility of Intervention Measure (FIM) from baseline (post-training) to post-treatment.||||0.34
72409191|NCT02550652|144326849|SUPERIORITY||Difference in Percentage of Participants|12.3||||0.1145|TWO_SIDED|95.0|-3.4|28.1||"Stratified by race (Afro Caribbean/African American vs. Others) and region (US vs. non-US sites).~Statistically significant at pre-specified alpha of 20%."|Cochran-Mantel-Haenszel|||||28.1|-3.4|0.1145
72573793|NCT01781481|144674313|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\<0.05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Psychological Domain Score (psychological needs) and Impact Quality of Life: Social Scale||||<0.01
72573794|NCT01781481|144674313|SUPERIORITY_OR_OTHER||||||<|0.05||||||The threshold for significance is p\<0.05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Psychological Domain Score (psychological needs) and Pediatric Inventory for Parents: Difficulty Score (parenting stress).||||<0.05
72626982|NCT00945659|144783223|SUPERIORITY||Mean Difference (Net)|-3.71|STANDARD_DEVIATION|1.36||0.007|TWO_SIDED|95.0|-6.38|-1.04|||Generalized Estimating Equation|||||-1.04|-6.38|.007
72626983|NCT00945659|144783224|SUPERIORITY||Mean Difference (Net)|0.39|STANDARD_DEVIATION|1.23||0.75|TWO_SIDED|95.0|-2.02|2.79|||Generalized Estimating Equation|||||2.79|-2.02|0.75
72626984|NCT00945659|144783224|SUPERIORITY||Mean Difference (Net)|-0.39|STANDARD_DEVIATION|1.38||0.78|TWO_SIDED|95.0|-3.09|2.32|||Generalized Estimating Equation|||||2.32|-3.09|0.78
72537824|NCT03692078|144605782|EQUIVALENCE|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 3 is equal to Group 1 on Day 7.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 3 is NOT equal to Group 1 on Day 7. (mITT Population)"|Mean Difference (Net)|-0.274||||0.0044|TWO_SIDED|95.0|-0.489|-0.059|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 3 is equal to Group 1 on Day 7.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 3 is NOT equal to Group 1 on Day 7. (mITT Population)"||-0.059|-0.489|0.0044
72537825|NCT03692078|144605782|EQUIVALENCE|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 4 is equal to Group 1 on Day 5.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 4 is NOT equal to Group 1 on Day 5. (mITT Population)"|Mean Difference (Net)|-1.235|||<|0.0001|TWO_SIDED|95.0|-1.539|-0.93|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 4 is equal to Group 1 on Day 5.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 4 is NOT equal to Group 1 on Day 5. (mITT Population)"||-0.930|-1.539|<.0001
72537826|NCT03692078|144605782|EQUIVALENCE|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 4 is equal to Group 1 on Day 7.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 4 is NOT equal to Group 1 on Day 7. (mITT Population)"|Mean Difference (Net)|-1.229|||<|0.0001|TWO_SIDED|95.0|-1.475|-0.983|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 4 is equal to Group 1 on Day 7.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 4 is NOT equal to Group 1 on Day 7. (mITT Population)"||-0.983|-1.475|<.0001
72537827|NCT03692078|144605782|EQUIVALENCE|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 5 is equal to Group 1 on Day 5.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 5 is NOT equal to Group 1 on Day 5. (mITT Population)"|Mean Difference (Net)|-0.93|||<|0.0001|TWO_SIDED|95.0|-1.23|-0.63|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 5 is equal to Group 1 on Day 5.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 5 is NOT equal to Group 1 on Day 5. (mITT Population)"||-0.630|-1.230|<.0001
72537828|NCT03692078|144605782|EQUIVALENCE|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 5 is equal to Group 1 on Day 7.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 5 is NOT equal to Group 1 on Day 7. (mITT Population)"|Mean Difference (Net)|-1.14|||<|0.0001|TWO_SIDED|95.0|-1.383|-0.896|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 5 is equal to Group 1 on Day 7.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 5 is NOT equal to Group 1 on Day 7. (mITT Population)"||-0.896|-1.383|<.0001
72537829|NCT03692078|144605782|EQUIVALENCE|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 2 is equal to Group 6 on Day 5.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 2 is NOT equal to Group 6 on Day 5. (mITT Population)"|Mean Difference (Net)|0.723|||<|0.0001|TWO_SIDED|95.0|0.436|1.009|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 2 is equal to Group 6 on Day 5.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 2 is NOT equal to Group 6 on Day 5. (mITT Population)"||1.009|0.436|<.0001
72537830|NCT03692078|144605782|EQUIVALENCE|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 2 is equal to Group 6 on Day 7.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 2 is NOT equal to Group 6 on Day 7. (mITT Population)"|Mean Difference (Net)|0.901|||<|0.0001|TWO_SIDED|95.0|0.667|1.134|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 2 is equal to Group 6 on Day 7.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 2 is NOT equal to Group 6 on Day 7. (mITT Population)"||1.134|0.667|<.0001
72537831|NCT03692078|144605782|EQUIVALENCE|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 3 is equal to Group 6 on Day 5.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 3 is NOT equal to Group 6 on Day 5. (mITT Population)"|Mean Difference (Net)|0.821|||<|0.0001|TWO_SIDED|95.0|0.533|1.109|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 3 is equal to Group 6 on Day 5.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 3 is NOT equal to Group 6 on Day 5. (mITT Population)"||1.109|0.533|<.0001
72573795|NCT01781481|144674313|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\<0.05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Psychological Domain Score (psychological needs) and Family Inventory of Life Events (family stress measure).||||<0.01
72626985|NCT00945659|144783225|SUPERIORITY||Mean Difference (Net)|0.72|STANDARD_DEVIATION|1.31||0.58|TWO_SIDED|95.0|-1.86|3.29|||Generalized Estimating Equation|||||3.29|-1.86|0.58
72369203|NCT00611026|144248554|SUPERIORITY_OR_OTHER|||||||0.0228|TWO_SIDED|||||Comparison fesoterodine vs tolterodine ER performed only if statistical significance favoring fesoterodine achieved for fesoterodine vs placebo to preserve overall alpha level at 5%; pairwise comparison also performed for tolterodine ER vs placebo.|Van Elteren's Test|P-value based on Van Elteren's Test (a stratified Wilcoxon-Mann Whitney test) adjusted by baseline UUI quartile.||Treatment difference tolterodine ER vs placebo at Week 12. Treatment effects estimated by Winsorized means (5% of the tails were censored, ie, replaced with the value at the 5th and 95th percentile, respectively).||||0.0228
72537832|NCT03692078|144605782|EQUIVALENCE|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 3 is equal to Group 6 on Day 7.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 3 is NOT equal to Group 6 on Day 7. (mITT Population)"|Mean Difference (Net)|0.907|||<|0.0001|TWO_SIDED|95.0|0.675|1.14|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 3 is equal to Group 6 on Day 7.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 3 is NOT equal to Group 6 on Day 7. (mITT Population)"||1.140|.675|<.0001
72537833|NCT03692078|144605782|EQUIVALENCE|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 4 is equal to Group 6 on Day 5.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 4 is NOT equal to Group 6 on Day 5. (mITT Population)"|Mean Difference (Net)|-0.133||||0.8291|TWO_SIDED|95.0|-0.453|0.188|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 4 is equal to Group 6 on Day 5.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 4 is NOT equal to Group 6 on Day 5. (mITT Population)"||0.188|-0.453|.8291
72537834|NCT03692078|144605782|EQUIVALENCE|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 4 is equal to Group 6 on Day 7.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 4 is NOT equal to Group 6 on Day 7. (mITT Population)"|Mean Difference (Net)|-0.048||||0.9997|TWO_SIDED|95.0|-0.308|0.213|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 4 is equal to Group 6 on Day 7.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 4 is NOT equal to Group 6 on Day 7. (mITT Population)"||0.213|-0.308|0.9997
72537835|NCT03692078|144605782|EQUIVALENCE|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 5 is equal to Group 6 on Day 5.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 5 is NOT equal to Group 6 on Day 5. (mITT Population)"|Mean Difference (Net)|0.172||||0.5755|TWO_SIDED|95.0|-0.145|0.488|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 5 is equal to Group 6 on Day 5.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 5 is NOT equal to Group 6 on Day 5. (mITT Population)"||0.488|-0.145|0.5755
72537836|NCT03692078|144605782|EQUIVALENCE|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 5 is equal to Group 6 on Day 7.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 5 is NOT equal to Group 6 on Day 7. (mITT Population)"|Mean Difference (Net)|0.042||||0.9999|TWO_SIDED|95.0|-0.217|0.301|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 5 is equal to Group 6 on Day 7.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 5 is NOT equal to Group 6 on Day 7. (mITT Population)"||0.301|-0.217|0.9999
72537837|NCT03692078|144605784|EQUIVALENCE|"Null hypothesis: NNN amount excreted (ng/24 hour) in Group 1 is equal to zero on Day 5.~Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 1 is NOT equal to zero on Day 5. (mITT Population)"|Mean Difference (Net)|2.629|||<|0.0001|TWO_SIDED|95.0|2.317|2.94|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|"Null hypothesis: NNN amount excreted (ng/24 hour) in Group 1 is equal to zero on Day 5.~Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 1 is NOT equal to zero on Day 5. (mITT Population)"||2.940|2.317|<.0001
72409192|NCT02550652|144326849|SUPERIORITY||Difference in Percentage of Participants|12.3||||0.1145|TWO_SIDED|80.0|2.1|22.6||"Stratified by race (Afro Caribbean/African American vs. Others) and region (US vs. non-US sites).~Statistically significant at pre-specified alpha of 20%."|Cochran-Mantel-Haenszel|Difference in Percentage of Participants||||22.6|2.1|0.1145
72537838|NCT03692078|144605784|EQUIVALENCE|"Null hypothesis: NNN amount excreted (ng/24 hour) in Group 1 is equal to zero on Day 7.~Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 1 is NOT equal to zero on Day 7. (mITT Population)"|Mean Difference (Net)|2.632|||<|0.0001|TWO_SIDED|95.0|2.321|2.943|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|"Null hypothesis: NNN amount excreted (ng/24 hour) in Group 1 is equal to zero on Day 7.~Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 1 is NOT equal to zero on Day 7. (mITT Population)"||2.943|2.321|<.0001
72573796|NCT01781481|144674313|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\<0.05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Psychological Domain Score (psychological needs) and Family Inventory of Resources for Management (family resources measure).||||<0.01
72573797|NCT01781481|144674313|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\<0.05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Social Domain Score (social needs) and Internalizing Problems (Child Behaviour Checklist).||||<0.01
72573798|NCT01781481|144674313|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\<0.05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Social Domain Score (social needs) and Externalizing Problems (Child Behaviour Checklist).||||<0.01
72409193|NCT02550652|144326850|SUPERIORITY||Difference in Percentage of Participants|20.1||||0.0246||95.0|3.0|37.2||"Stratified by race (Afro Caribbean/African American vs. Others) and region (US vs. non-US sites).~Statistically significant at pre-specified alpha of 20%."|Cochran-Mantel-Haenszel|||||37.2|3.0|0.0246
72409194|NCT02550652|144326850|SUPERIORITY||Difference in Percentage of Participants|20.1||||0.0246|TWO_SIDED|80.0|8.9|31.3||"Stratified by race (Afro Caribbean/African American vs. Others) and region (US vs. non-US sites).~Statistically significant at pre-specified alpha of 20%."|Cochran-Mantel-Haenszel|||||31.3|8.9|0.0246
72409195|NCT02550652|144326851|SUPERIORITY|||||||0.0744|||||||Log Rank|||||||0.0744
72626986|NCT00945659|144783225|SUPERIORITY||Mean Difference (Net)|-0.93|STANDARD_DEVIATION|1.14||0.41|TWO_SIDED|95.0|-3.17|1.3|||Generalized Estimating Equation|||||1.3|-3.17|0.41
72537839|NCT03692078|144605784|EQUIVALENCE|"Null hypothesis: NNN amount excreted (ng/24 hour) in Group 2 is equal to zero on Day 5.~Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 2 is NOT equal to zero on Day 5. (mITT Population)"|Mean Difference (Net)|2.006|||<|0.0001|TWO_SIDED|95.0|1.714|2.298|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|"Null hypothesis: NNN amount excreted (ng/24 hour) in Group 2 is equal to zero on Day 5.~Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 2 is NOT equal to zero on Day 5. (mITT Population)"||2.298|1.714|<.0001
72626987|NCT00945659|144783226|SUPERIORITY||Mean Difference (Net)|1.95|STANDARD_DEVIATION|2.66||0.46|TWO_SIDED|95.0|-3.26|7.15|||Generalized Estimating Equation|||||7.15|-3.26|0.46
72626988|NCT00945659|144783226|SUPERIORITY||Mean Difference (Net)|-3.01|STANDARD_DEVIATION|2.54||0.24|TWO_SIDED|95.0|-7.99|1.96|||Generalized Estimating Equation|||||1.96|-7.99|0.24
72626989|NCT00945659|144783227|SUPERIORITY||Mean Difference (Net)|0.31|STANDARD_DEVIATION|3.37||0.93|TWO_SIDED|95.0|-6.33|6.91|||Generalized Estimating Equation|||||6.91|-6.33|0.93
72626990|NCT00945659|144783227|SUPERIORITY||Mean Difference (Net)|-2.21|STANDARD_DEVIATION|2.95||0.45|TWO_SIDED|95.0|-8.01|3.57|||Generalized Estimating Equation|||||3.57|-8.01|0.45
72626991|NCT00945659|144783228|SUPERIORITY||Mean Difference (Net)|-0.77|STANDARD_DEVIATION|3.26||0.81|TWO_SIDED|95.0|-7.15|5.62|||Generalized Estimating Equestion|||||5.62|-7.15|0.81
72626992|NCT00945659|144783228|SUPERIORITY||Mean Difference (Net)|0.99|STANDARD_DEVIATION|2.63||0.72|TWO_SIDED|95.0|-4.11|6.08|||Generalized Estimating Equation|||||6.08|-4.11|0.72
72369231|NCT00611026|144248558|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.04|STANDARD_ERROR_OF_MEAN|0.1||0.4802|TWO_SIDED|95.0|-0.1|0.1|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.|"Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type:~standard error of the mean."|Treatment difference Tolterodine ER vs placebo at Week 1.||0.1|-0.1|0.4802
72409196|NCT02550652|144326852|SUPERIORITY||Difference in Percentage of Participants|21.7||||0.015||95.0|4.7|38.7||"Stratified by race (Afro Caribbean/African American vs. Others) and region (US vs. non-US sites).~Statistically significant at pre-specified alpha of 20%."|Cochran-Mantel-Haenszel|||||38.7|4.7|0.0150
72537840|NCT03692078|144605784|EQUIVALENCE|"Null hypothesis: NNN amount excreted (ng/24 hour) in Group 2 is equal to zero on Day 7.~Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 2 is NOT equal to zero on Day 7. (mITT Population)"|Mean Difference (Net)|2.143|||<|0.0001|TWO_SIDED|95.0|1.847|2.44|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|"Null hypothesis: NNN amount excreted (ng/24 hour) in Group 2 is equal to zero on Day 7.~Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 2 is NOT equal to zero on Day 7. (mITT Population)"||2.440|1.847|<.0001
72537841|NCT03692078|144605784|EQUIVALENCE|"Null hypothesis: NNN amount excreted (ng/24 hour) in Group 3 is equal to zero on Day 5.~Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 3 is NOT equal to zero on Day 5. (mITT Population)"|Mean Difference (Net)|1.987|||<|0.0001|TWO_SIDED|95.0|1.69|2.284|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|"Null hypothesis: NNN amount excreted (ng/24 hour) in Group 3 is equal to zero on Day 5.~Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 3 is NOT equal to zero on Day 5. (mITT Population)"||2.284|1.690|<.0001
72573799|NCT01781481|144674313|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\<0.05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Social Domain Score (social needs) and Children's Depression Inventory: Total Score||||<0.01
72573800|NCT01781481|144674313|SUPERIORITY_OR_OTHER||||||<|0.05||||||The threshold for significance is p\<0.05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Social Domain Score (social needs) and Multidimensional Anxiety Scale for Children: Total Score.||||<0.05
72573801|NCT01781481|144674313|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\<0.05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Social Domain Score (social needs) and Impact Quality of Life: Emotional Scale||||<0.01
72369232|NCT00611026|144248558|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.0||0.8355|TWO_SIDED|95.0|-0.1|0.1|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.|"Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type:~standard error of the mean."|Treatment difference fesoterodine vs Tolterodine ER at Week 1.||0.1|-0.1|0.8355
72573802|NCT01781481|144674313|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\<0.05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Social Domain Score (social needs) and Social Competence Scale (Child Behaviour Checklist).||||<0.01
72573803|NCT01781481|144674313|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\<0.05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Social Domain Score (social needs) and Activities Competence Scale (Child Behaviour Checklist).||||<0.01
72626993|NCT00945659|144783229|SUPERIORITY||Mean Difference (Net)|0.99|STANDARD_DEVIATION|2.6||0.71|TWO_SIDED|95.0|-4.11|6.08|||Generalized Estimating Equation|||||6.08|-4.11|0.71
72626994|NCT00945659|144783229|SUPERIORITY||Mean Difference (Net)|-1.16|STANDARD_DEVIATION|2.85||0.68|TWO_SIDED|95.0|-6.74|4.43|||Generalized Estimating Equation|||||4.43|-6.74|0.68
72626995|NCT00833521|144783232|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Ratio of Geometric Means|91.1||||||90.0|86.3|96.1|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||96.1|86.3|
72626996|NCT00833521|144783233|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Ratio of Geometric Means|97.0||||||90.0|91.0|103.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||103|91.0|
72537842|NCT03692078|144605784|EQUIVALENCE|"Null hypothesis: NNN amount excreted (ng/24 hour) in Group 3 is equal to zero on Day 7.~Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 3 is NOT equal to zero on Day 7. (mITT Population)"|Mean Difference (Net)|2.261|||<|0.0001|TWO_SIDED|95.0|1.964|2.559|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|"Null hypothesis: NNN amount excreted (ng/24 hour) in Group 3 is equal to zero on Day 7.~Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 3 is NOT equal to zero on Day 7. (mITT Population)"||2.559|1.964|<.0001
72537843|NCT03692078|144605784|EQUIVALENCE|"Null hypothesis: NNN amount excreted (ng/24 hour) in Group 4 is equal to zero on Day 5.~Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 4 is NOT equal to zero on Day 5. (mITT Population)"|Mean Difference (Net)|-0.263||||0.1658|TWO_SIDED|95.0|-0.635|0.109|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|"Null hypothesis: NNN amount excreted (ng/24 hour) in Group 4 is equal to zero on Day 5.~Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 4 is NOT equal to zero on Day 5. (mITT Population)"||0.109|-0.635|0.1658
72537844|NCT03692078|144605784|EQUIVALENCE|"Null hypothesis: NNN amount excreted (ng/24 hour) in Group 4 is equal to zero on Day 7.~Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 4 is NOT equal to zero on Day 7. (mITT Population)"|Mean Difference (Net)|-0.659||||0.0007|TWO_SIDED|95.0|-1.036|-0.282|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|"Null hypothesis: NNN amount excreted (ng/24 hour) in Group 4 is equal to zero on Day 7.~Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 4 is NOT equal to zero on Day 7. (mITT Population)"||-0.282|-1.036|0.0007
72537845|NCT03692078|144605784|NON_INFERIORITY|"Null hypothesis: NNN amount excreted (ng/24 hour) in Group 5 is equal to zero on Day 5.~Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 5 is NOT equal to zero on Day 5. (mITT Population)"|Mean Difference (Net)|-0.302||||0.1055|TWO_SIDED|95.0|-0.667|0.064|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|"Null hypothesis: NNN amount excreted (ng/24 hour) in Group 5 is equal to zero on Day 5.~Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 5 is NOT equal to zero on Day 5. (mITT Population)"||0.064|-0.667|0.1055
72537846|NCT03692078|144605784|EQUIVALENCE|"Null hypothesis: NNN amount excreted (ng/24 hour) in Group 5 is equal to zero on Day 7.~Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 5 is NOT equal to zero on Day 7. (mITT Population)"|Mean Difference (Net)|-0.243||||0.204|TWO_SIDED|95.0|-0.617|0.132|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|"Null hypothesis: NNN amount excreted (ng/24 hour) in Group 5 is equal to zero on Day 7.~Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 5 is NOT equal to zero on Day 7. (mITT Population)"||0.132|-0.617|0.2040
72537847|NCT03692078|144605784|EQUIVALENCE|"Null hypothesis: NNN amount excreted (ng/24 hour) in Group 6 is equal to zero on Day 5.~Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 6 is NOT equal to zero on Day 5. (mITT Population)"|Mean Difference (Net)|-0.244||||0.1829|TWO_SIDED|95.0|-0.603|0.116|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|"Null hypothesis: NNN amount excreted (ng/24 hour) in Group 6 is equal to zero on Day 5.~Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 6 is NOT equal to zero on Day 5. (mITT Population)"||0.116|-0.603|0.1829
72537848|NCT03692078|144605784|EQUIVALENCE|"Null hypothesis: NNN amount excreted (ng/24 hour) in Group 6 is equal to zero on Day 7.~Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 6 is NOT equal to zero on Day 7. (mITT Population)"|Mean Difference (Net)|-0.248||||0.1801|TWO_SIDED|95.0|-0.612|0.115|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|"Null hypothesis: NNN amount excreted (ng/24 hour) in Group 6 is equal to zero on Day 7.~Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 6 is NOT equal to zero on Day 7. (mITT Population)"||0.115|-0.612|0.1801
72573804|NCT01781481|144674313|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\<0.05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Social Domain Score (social needs) and Academic Competence Scale (Child Behaviour Checklist).||||<0.01
72573805|NCT01781481|144674313|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\<0.05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Social Domain Score (social needs) and Impact Quality of Life: Social Scale||||<0.01
72573806|NCT01781481|144674313|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\<0.05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Social Domain Score (social needs) and Pediatric Inventory for Parents: Difficulty Score (parenting stress).||||<0.01
72573807|NCT01781481|144674313|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\<0.05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Social Domain Score (social needs) and Family Inventory of Life Events (family stress measure).||||<0.01
72573808|NCT01781481|144674313|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\<0.05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Social Domain Score (social needs) and Family Inventory of Resources for Management (family resources measure).||||<0.01
72409197|NCT02550652|144326852|SUPERIORITY||Difference in Percentage of Participants|21.7||||0.015|TWO_SIDED|80.0|10.6|32.8||"Stratified by race (Afro Caribbean/African American vs. Others) and region (US vs. non-US sites).~Statistically significant at pre-specified alpha of 20%."|Cochran-Mantel-Haenszel|||||32.8|10.6|0.0150
72369233|NCT00611026|144248558|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.12|STANDARD_ERROR_OF_MEAN|0.1||0.0286|TWO_SIDED|95.0|-0.12|0.0|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.|"Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type:~standard error of the mean."|Treatment difference fesoterodine vs placebo at Week 4.||-0.0|-0.12|0.0286
72537849|NCT03692078|144605784|EQUIVALENCE|Null hypothesis: NNN amount excreted (ng/24 hour) in Group 2 is equal to Group 1 on Day 5. Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 2 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-0.622||||0.0391|TWO_SIDED|95.0|-1.225|-0.019|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: NNN amount excreted (ng/24 hour) in Group 2 is equal to Group 1 on Day 5. Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 2 is NOT equal to Group 1 on Day 5. (mITT Population)||-0.019|-1.225|0.0391
72537850|NCT03692078|144605784|EQUIVALENCE|Null hypothesis: NNN amount excreted (ng/24 hour) in Group 2 is equal to Group 1 on Day 7. Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 2 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-0.489||||0.1864|TWO_SIDED|95.0|-1.096|0.119|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: NNN amount excreted (ng/24 hour) in Group 2 is equal to Group 1 on Day 7. Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 2 is NOT equal to Group 1 on Day 7. (mITT Population)||0.119|-1.096|0.1864
72537851|NCT03692078|144605784|EQUIVALENCE|Null hypothesis: NNN amount excreted (ng/24 hour) in Group 3 is equal to Group 1 on Day 5. Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 3 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-0.642||||0.031|TWO_SIDED|95.0|-1.246|-0.037|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: NNN amount excreted (ng/24 hour) in Group 3 is equal to Group 1 on Day 5. Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 3 is NOT equal to Group 1 on Day 5. (mITT Population)||-0.037|-1.246|0.0310
72537852|NCT03692078|144605784|EQUIVALENCE|"Null hypothesis: NNN amount excreted (ng/24 hour) in Group 3 is equal to Group 1 on Day 7.~Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 3 is NOT equal to Group 1 on Day 7. (mITT Population)"|Mean Difference (Net)|-0.642||||0.031|TWO_SIDED|95.0|-1.246|-0.037|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|"Null hypothesis: NNN amount excreted (ng/24 hour) in Group 3 is equal to Group 1 on Day 7.~Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 3 is NOT equal to Group 1 on Day 7. (mITT Population)"||-0.037|-1.246|0.0310
72537853|NCT03692078|144605784|EQUIVALENCE|Null hypothesis: NNN amount excreted (ng/24 hour) in Group 4 is equal to Group 1 on Day 5. Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 4 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-2.891|||<|0.0001|TWO_SIDED|95.0|-3.58|-2.202|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: NNN amount excreted (ng/24 hour) in Group 4 is equal to Group 1 on Day 5. Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 4 is NOT equal to Group 1 on Day 5. (mITT Population)||-2.202|-3.580|<.0001
72537854|NCT03692078|144605784|EQUIVALENCE|Null hypothesis: NNN amount excreted (ng/24 hour) in Group 4 is equal to Group 1 on Day 7. Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 4 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-3.291|||<|0.0001|TWO_SIDED|95.0|-3.985|-2.597|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: NNN amount excreted (ng/24 hour) in Group 4 is equal to Group 1 on Day 7. Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 4 is NOT equal to Group 1 on Day 7. (mITT Population)||-2.597|-3.985|<.0001
72573809|NCT01781481|144674313|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\<0.05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Caregiver/Family Domain Score (caregiver/family needs) and Internalizing Problems (Child Behaviour Checklist).||||<0.01
72573810|NCT01781481|144674313|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\<0.05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Caregiver/Family Domain Score (caregiver/family needs) and Externalizing Problems (Child Behaviour Checklist).||||<0.01
72573811|NCT01781481|144674313|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\<0.05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Caregiver/Family Domain Score (caregiver/family needs) and Children's Depression Inventory: Total Score||||<0.01
72573812|NCT01781481|144674313|SUPERIORITY_OR_OTHER||||||>|0.05||||||The threshold for significance is p\<0.05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Caregiver/Family Domain Score (caregiver/family needs) and Multidimensional Anxiety Scale for Children: Total Score.||||>0.05
72573813|NCT01781481|144674313|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\<0.05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Psychological Domain Score (psychological needs) and Impact Quality of Life: Emotional Scale||||<0.01
72626997|NCT00833521|144783234|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Ratio of Geometric Means|96.8||||||90.0|90.7|103.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||103|90.7|
72626998|NCT01405196|144783260|SUPERIORITY||Odds Ratio (OR)|2.23||||0.076|TWO_SIDED|90.0|0.89|5.62||P-value was displayed without adjusting for multiplicity.|Mixed Models Analysis|||Point estimates of the Odds ratio (ORs) as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.||5.62|0.89|0.076
72537855|NCT03692078|144605784|EQUIVALENCE|Null hypothesis: NNN amount excreted (ng/24 hour) in Group 5 is equal to Group 1 on Day 5. Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 5 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-2.93|||<|0.0001|TWO_SIDED|95.0|-3.605|-2.255|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: NNN amount excreted (ng/24 hour) in Group 5 is equal to Group 1 on Day 5. Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 5 is NOT equal to Group 1 on Day 5. (mITT Population)||-2.255|-3.605|<.0001
72537856|NCT03692078|144605784|EQUIVALENCE|Null hypothesis: NNN amount excreted (ng/24 hour) in Group 5 is equal to Group 1 on Day 7. Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 5 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-2.875|||<|0.0001|TWO_SIDED|95.0|-3.559|-2.19|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: NNN amount excreted (ng/24 hour) in Group 5 is equal to Group 1 on Day 7. Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 5 is NOT equal to Group 1 on Day 7. (mITT Population)||-2.190|-3.559|<.0001
72537857|NCT03692078|144605784|EQUIVALENCE|Null hypothesis: NNN amount excreted (ng/24 hour) in Group 2 is equal to Group 6 on Day 5. Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 2 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|2.25|||<|0.0001|TWO_SIDED|95.0|1.604|2.896|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: NNN amount excreted (ng/24 hour) in Group 2 is equal to Group 6 on Day 5. Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 2 is NOT equal to Group 6 on Day 5. (mITT Population)||2.896|1.604|<.0001
72537858|NCT03692078|144605784|EQUIVALENCE|Null hypothesis: NNN amount excreted (ng/24 hour) in Group 2 is equal to Group 6 on Day 7. Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 2 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|2.391|||<|0.0001|TWO_SIDED|95.0|1.737|3.046|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: NNN amount excreted (ng/24 hour) in Group 2 is equal to Group 6 on Day 7. Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 2 is NOT equal to Group 6 on Day 7. (mITT Population)||3.046|1.737|<.0001
72537859|NCT03692078|144605784|EQUIVALENCE|Null hypothesis: NNN amount excreted (ng/24 hour) in Group 3 is equal to Group 6 on Day 5. Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 3 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|2.231|||<|0.0001|TWO_SIDED|95.0|1.582|2.879|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: NNN amount excreted (ng/24 hour) in Group 3 is equal to Group 6 on Day 5. Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 3 is NOT equal to Group 6 on Day 5. (mITT Population)||2.879|1.582|<.0001
72537860|NCT03692078|144605784|EQUIVALENCE|Null hypothesis: NNN amount excreted (ng/24 hour) in Group 3 is equal to Group 6 on Day 7. Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 3 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|2.509|||<|0.0001|TWO_SIDED|95.0|1.857|3.162|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: NNN amount excreted (ng/24 hour) in Group 3 is equal to Group 6 on Day 7. Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 3 is NOT equal to Group 6 on Day 7. (mITT Population)||3.162|1.857|<.0001
72537861|NCT03692078|144605784|EQUIVALENCE|Null hypothesis: NNN amount excreted (ng/24 hour) in Group 4 is equal to Group 6 on Day 5. Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 4 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|-0.019||||1|TWO_SIDED|95.0|-0.743|0.705|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: NNN amount excreted (ng/24 hour) in Group 4 is equal to Group 6 on Day 5. Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 4 is NOT equal to Group 6 on Day 5. (mITT Population)||0.705|-0.743|1.0000
72537862|NCT03692078|144605784|EQUIVALENCE|Null hypothesis: NNN amount excreted (ng/24 hour) in Group 4 is equal to Group 6 on Day 7. Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 4 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|-0.411||||0.5639|TWO_SIDED|95.0|-1.142|0.32|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: NNN amount excreted (ng/24 hour) in Group 4 is equal to Group 6 on Day 7. Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 4 is NOT equal to Group 6 on Day 7. (mITT Population)||0.320|-1.142|0.5639
72573814|NCT01781481|144674313|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\<0.05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Caregiver/Family Domain Score (caregiver/family needs) and Social Competence Scale (Child Behaviour Checklist).||||<0.01
72573815|NCT01781481|144674313|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\<0.05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Caregiver/Family Domain Score (caregiver/family needs) and Activities Competence Scale (Child Behaviour Checklist).||||<0.01
72573816|NCT01781481|144674313|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Caregiver/Family Domain Score (caregiver/family needs) and Academic Competence Scale (Child Behaviour Checklist).||||<0.01
72573817|NCT01781481|144674313|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\<0.05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Caregiver/Family Domain Score (caregiver/family needs) and Impact Quality of Life: Social Scale||||<0.01
72626999|NCT01405196|144783260|SUPERIORITY||Odds Ratio (OR)|0.96||||0.528|TWO_SIDED|90.0|0.38|2.41||P-value was displayed without adjusting for multiplicity.|Mixed Models Analysis|||Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.||2.41|0.38|0.528
72627000|NCT01405196|144783261|SUPERIORITY||Odds Ratio (OR)|2.77|||||TWO_SIDED|90.0|0.62|12.4||||||Week 4: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.||12.40|0.62|
72627001|NCT01405196|144783261|SUPERIORITY||Odds Ratio (OR)|1.54|||||TWO_SIDED|90.0|0.31|7.71||||||Week 4: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.||7.71|0.31|
72627002|NCT01405196|144783261|SUPERIORITY||Odds Ratio (OR)|1.03|||||TWO_SIDED|90.0|0.4|2.67||||||Week 8: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.||2.67|0.40|
72627003|NCT01405196|144783261|SUPERIORITY||Odds Ratio (OR)|0.77|||||TWO_SIDED|90.0|0.29|2.05||||||Week 8: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.||2.05|0.29|
72627004|NCT01405196|144783261|SUPERIORITY||Odds Ratio (OR)|0.89|||||TWO_SIDED|90.0|0.35|2.24||||||Week 12: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.||2.24|0.35|
72627005|NCT01405196|144783261|SUPERIORITY||Odds Ratio (OR)|0.44|||||TWO_SIDED|90.0|0.16|1.16||||||Week 12: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.||1.16|0.16|
72627006|NCT01405196|144783261|SUPERIORITY||Odds Ratio (OR)|1.62|||||TWO_SIDED|90.0|0.64|4.09||||||Week 16: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.||4.09|0.64|
72627007|NCT01405196|144783261|SUPERIORITY||Odds Ratio (OR)|0.69|||||TWO_SIDED|90.0|0.27|1.77||||||Week 16: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.||1.77|0.27|
72627008|NCT01405196|144783261|SUPERIORITY||Odds Ratio (OR)|1.95|||||TWO_SIDED|90.0|0.78|4.84||||||Week 20: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.||4.84|0.78|
72537863|NCT03692078|144605784|EQUIVALENCE|Null hypothesis: NNN amount excreted (ng/24 hour) in Group 5 is equal to Group 6 on Day 5. Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 5 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|-0.058||||1|TWO_SIDED|95.0|-0.771|0.656|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: NNN amount excreted (ng/24 hour) in Group 5 is equal to Group 6 on Day 5. Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 5 is NOT equal to Group 6 on Day 5. (mITT Population)||0.656|-0.771|1.0000
72573818|NCT01781481|144674313|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\<0.05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Caregiver/Family Domain Score (caregiver/family needs) and Pediatric Inventory for Parents: Difficulty Score (parenting stress).||||<0.01
72573819|NCT01781481|144674313|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\<0.05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Psychological Domain Score (psychological needs) and Family Inventory of Life Events (family stress measure).||||<0.01
72627009|NCT01405196|144783261|SUPERIORITY||Odds Ratio (OR)|0.94|||||TWO_SIDED|90.0|0.38|2.32||||||Week 20: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.||2.32|0.38|
72627010|NCT01405196|144783262|SUPERIORITY||Odds Ratio (OR)|1.05|||||TWO_SIDED|90.0|0.28|3.88||||||Week 4: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.||3.88|0.28|
72627011|NCT01405196|144783262|SUPERIORITY||Odds Ratio (OR)|0.75|||||TWO_SIDED|90.0|0.19|3.01||||||Week 4: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.||3.01|0.19|
72627012|NCT01405196|144783262|SUPERIORITY||Odds Ratio (OR)|0.72|||||TWO_SIDED|90.0|0.28|1.85||||||Week 8: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.||1.85|0.28|
72627013|NCT01405196|144783262|SUPERIORITY||Odds Ratio (OR)|0.8|||||TWO_SIDED|90.0|0.32|2.02||||||Week 8: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.||2.02|0.32|
72627014|NCT01405196|144783262|SUPERIORITY||Odds Ratio (OR)|0.75|||||TWO_SIDED|90.0|0.3|1.83||||||Week 12: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.||1.83|0.30|
72573820|NCT01781481|144674313|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\<0.05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Caregiver/Family Domain Score (caregiver/family needs) and Family Inventory of Resources for Management (family resources measure).||||<0.01
72627015|NCT01405196|144783262|SUPERIORITY||Odds Ratio (OR)|0.45|||||TWO_SIDED|90.0|0.18|1.13||||||Week 12: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.||1.13|0.18|
72409198|NCT02550652|144326853|SUPERIORITY||Difference in Percentage of Participants|-2.0||||0.8461|TWO_SIDED|95.0|-17.5|13.4||"Stratified by race (Afro Caribbean/African American vs. Others) and region (US vs. non-US sites).~Statistically significant at pre-specified alpha of 20%."|Cochran-Mantel-Haenszel|||||13.4|-17.5|0.8461
72537864|NCT03692078|144605784|EQUIVALENCE|Null hypothesis: NNN amount excreted (ng/24 hour) in Group 5 is equal to Group 6 on Day 7. Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 5 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|0.006||||1|TWO_SIDED|95.0|-0.721|0.732|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: NNN amount excreted (ng/24 hour) in Group 5 is equal to Group 6 on Day 7. Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 5 is NOT equal to Group 6 on Day 7. (mITT Population)||0.732|-0.721|1.0000
72537865|NCT03692078|144605786|EQUIVALENCE|Null hypothesis: NE amount excreted (mg/24 hour) in Group 1 is equal to zero on Day 5. Alternate hypothesis: NE amount excreted (mg/24 hour) in Group 1 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|2.691|||<|0.0001|TWO_SIDED|95.0|2.519|2.863|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: NE amount excreted (mg/24 hour) in Group 1 is equal to zero on Day 5. Alternate hypothesis: NE amount excreted (mg/24 hour) in Group 1 is NOT equal to zero on Day 5. (mITT Population)||2.863|2.519|<.0001
72537866|NCT03692078|144605786|EQUIVALENCE|Null hypothesis: NE amount excreted (mg/24 hour) in Group 1 is equal to zero on Day 7. Alternate hypothesis: NE amount excreted (mg/24 hour) in Group 1 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|2.718|||<|0.0001|TWO_SIDED|95.0|2.546|2.89|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: NE amount excreted (mg/24 hour) in Group 1 is equal to zero on Day 7. Alternate hypothesis: NE amount excreted (mg/24 hour) in Group 1 is NOT equal to zero on Day 7. (mITT Population)||2.890|2.546|<.0001
72537867|NCT03692078|144605786|EQUIVALENCE|Null hypothesis: NE amount excreted (mg/24 hour) in Group 2 is equal to zero on Day 5. Alternate hypothesis: NE amount excreted (mg/24 hour) in Group 2 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|2.415|||<|0.0001|TWO_SIDED|95.0|2.252|2.577|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: NE amount excreted (mg/24 hour) in Group 2 is equal to zero on Day 5. Alternate hypothesis: NE amount excreted (mg/24 hour) in Group 2 is NOT equal to zero on Day 5. (mITT Population)||2.577|2.252|<.0001
72537868|NCT03692078|144605786|EQUIVALENCE|Null hypothesis: NE amount excreted (mg/24 hour) in Group 2 is equal to zero on Day 7. Alternate hypothesis: NE amount excreted (mg/24 hour) in Group 2 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|2.44|||<|0.0001|TWO_SIDED|95.0|2.276|2.603|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: NE amount excreted (mg/24 hour) in Group 2 is equal to zero on Day 7. Alternate hypothesis: NE amount excreted (mg/24 hour) in Group 2 is NOT equal to zero on Day 7. (mITT Population)||2.603|2.276|<.0001
72537869|NCT03692078|144605786|EQUIVALENCE|Null hypothesis: NE amount excreted (mg/24 hour) in Group 3 is equal to zero on Day 5. Alternate hypothesis: NE amount excreted (mg/24 hour) in Group 3 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|2.583|||<|0.0001|TWO_SIDED|95.0|2.417|2.748|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: NE amount excreted (mg/24 hour) in Group 3 is equal to zero on Day 5. Alternate hypothesis: NE amount excreted (mg/24 hour) in Group 3 is NOT equal to zero on Day 5. (mITT Population)||2.748|2.417|<.0001
72573821|NCT01781481|144674314|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|8.33|||||TWO_SIDED|95.0|2.02|34.47||||||||34.47|2.02|
72573822|NCT01781481|144674315|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|8.52|||||TWO_SIDED|95.0|1.7|43.02||||||||43.02|1.70|
72573823|NCT01781481|144674316|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|7.27|||||TWO_SIDED|95.0|2.17|24.36||||||||24.36|2.17|
72573824|NCT01781481|144674317|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|24.79|||||TWO_SIDED|95.0|5.0|122.84||||||||122.84|5.00|
72573825|NCT01781481|144674318|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\<0.05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Health System Domain Score (health system needs/complexity) and Number of Hospital Services involved in the child's care.||||<0.01
72573826|NCT01781481|144674318|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\<0.05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Health System Domain Score (health system needs/complexity) and Number of Inpatient Hospitalizations since IBD diagnosis.||||<0.01
72573827|NCT01781481|144674318|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\<0.05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Health System Domain Score (health system needs/complexity) and Number of Surgeries since IBD diagnosis.||||<0.01
72573828|NCT01781481|144674318|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\<0.05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Health System Domain Score (health system needs/complexity) and Family Financial Well Being||||<0.01
72573829|NCT01781481|144674318|SUPERIORITY_OR_OTHER||||||>|0.05||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Access to Health Care Item (historical/health system) and Number of Hospital Services Involved in the Child's Care."||||>0.05
72409199|NCT02550652|144326853|SUPERIORITY||Difference in Percentage of Participants|-2.0||||0.8461|TWO_SIDED|80.0|-12.1|8.1||"Stratified by race (Afro Caribbean/African American vs. Others) and region (US vs. non-US sites).~Statistically significant at pre-specified alpha of 20%."|Cochran-Mantel-Haenszel|||||8.1|-12.1|0.8461
72409200|NCT02550652|144326854|SUPERIORITY|||||||0.353|||||||Log Rank|||||||0.3530
72409201|NCT02550652|144326855|SUPERIORITY||Difference in Adjusted Mean|-0.81|||<|0.0001|TWO_SIDED|95.0|-1.13|-0.491||"Stratified by race (Afro Caribbean/African American vs. Others) and region (US vs. non-US sites).~Statistically significant at pre-specified alpha of 20%."|ANCOVA|||||-0.491|-1.13|<0.0001
72409202|NCT02550652|144326855|SUPERIORITY||Difference in Adjusted Mean|-0.81|||<|0.0001|TWO_SIDED|80.0|-1.019|-0.602||"Stratified by race (Afro Caribbean/African American vs. Others) and region (US vs. non-US sites).~Statistically significant at pre-specified alpha of 20%."|ANCOVA|||||-0.602|-1.019|<0.0001
72537870|NCT03692078|144605786|EQUIVALENCE|Null hypothesis: NE amount excreted (mg/24 hour) in Group 3 is equal to zero on Day 7. Alternate hypothesis: NE amount excreted (mg/24 hour) in Group 3 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|2.591|||<|0.0001|TWO_SIDED|95.0|2.426|2.757|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: NE amount excreted (mg/24 hour) in Group 3 is equal to zero on Day 7. Alternate hypothesis: NE amount excreted (mg/24 hour) in Group 3 is NOT equal to zero on Day 7. (mITT Population)||2.757|2.426|<.0001
72537871|NCT03692078|144605786|EQUIVALENCE|Null hypothesis: NE amount excreted (mg/24 hour) in Group 4 is equal to zero on Day 5. Alternate hypothesis: NE amount excreted (mg/24 hour) in Group 4 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|1.107|||<|0.0001|TWO_SIDED|95.0|0.901|1.314|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: NE amount excreted (mg/24 hour) in Group 4 is equal to zero on Day 5. Alternate hypothesis: NE amount excreted (mg/24 hour) in Group 4 is NOT equal to zero on Day 5. (mITT Population)||1.314|0.901|<.0001
72537872|NCT03692078|144605786|EQUIVALENCE|Null hypothesis: NE amount excreted (mg/24 hour) in Group 4 is equal to zero on Day 7. Alternate hypothesis: NE amount excreted (mg/24 hour) in Group 4 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|1.017|||<|0.0001|TWO_SIDED|95.0|0.81|1.225|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: NE amount excreted (mg/24 hour) in Group 4 is equal to zero on Day 7. Alternate hypothesis: NE amount excreted (mg/24 hour) in Group 4 is NOT equal to zero on Day 7. (mITT Population)||1.225|0.810|<.0001
72537873|NCT03692078|144605786|EQUIVALENCE|Null hypothesis: NE amount excreted (mg/24 hour) in Group 5 is equal to zero on Day 5. Alternate hypothesis: NE amount excreted (mg/24 hour) in Group 5 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|1.828|||<|0.0001|TWO_SIDED|95.0|1.624|2.031|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: NE amount excreted (mg/24 hour) in Group 5 is equal to zero on Day 5. Alternate hypothesis: NE amount excreted (mg/24 hour) in Group 5 is NOT equal to zero on Day 5. (mITT Population)||2.031|1.624|<.0001
72537874|NCT03692078|144605786|EQUIVALENCE|Null hypothesis: NE amount excreted (mg/24 hour) in Group 5 is equal to zero on Day 7. Alternate hypothesis: NE amount excreted (mg/24 hour) in Group 5 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|1.782|||<|0.0001|TWO_SIDED|95.0|1.577|1.988|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: NE amount excreted (mg/24 hour) in Group 5 is equal to zero on Day 7. Alternate hypothesis: NE amount excreted (mg/24 hour) in Group 5 is NOT equal to zero on Day 7. (mITT Population)||1.988|1.577|<.0001
72537875|NCT03692078|144605786|EQUIVALENCE|Null hypothesis: NE amount excreted (mg/24 hour) in Group 6 is equal to zero on Day 5. Alternate hypothesis: NE amount excreted (mg/24 hour) in Group 6 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|-0.55|||<|0.0001|TWO_SIDED|95.0|-0.75|-0.35|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: NE amount excreted (mg/24 hour) in Group 6 is equal to zero on Day 5. Alternate hypothesis: NE amount excreted (mg/24 hour) in Group 6 is NOT equal to zero on Day 5. (mITT Population)||-0.350|-0.750|<.0001
72573830|NCT01781481|144674318|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Access to Health Care Item (historical/health system) and Number of Hospitalizations since Child's IBD Diagnosis."||||<0.01
72573831|NCT01781481|144674318|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Access to Health Care Item (historical/health system) and Number of Surgeries since Diagnosis."||||<0.01
72573832|NCT01781481|144674318|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Access to Health Care Item (historical/health system) and Family Financial Well-Being."||||<0.01
72409203|NCT02550652|144326856|SUPERIORITY||Difference in Adjusted Mean|0.178||||0.0004|TWO_SIDED|95.0|0.081|0.275||"Stratified by race (Afro Caribbean/African American vs. Others) and region (US vs. non-US sites).~Statistically significant at pre-specified alpha of 20%."|ANCOVA|||||0.275|0.081|0.0004
72573833|NCT01781481|144674318|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Treatment Experience Item (historical/health system) and Number of Hospital Services Involved in the Child's Care."||||<0.01
72627016|NCT01405196|144783262|SUPERIORITY||Odds Ratio (OR)|1.45|||||TWO_SIDED|90.0|0.58|3.6||||||Week 16: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.||3.60|0.58|
72409204|NCT02550652|144326856|SUPERIORITY||Difference in Adjusted Mean|0.178||||0.0004|TWO_SIDED|80.0|0.115|0.241|||ANCOVA|||||0.241|0.115|0.0004
72573834|NCT01781481|144674318|SUPERIORITY_OR_OTHER||||||>|0.05||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Treatment Experience Item (historical/health system) and Number of Hospitalizations since Child's IBD Diagnosis."||||>0.05
72573835|NCT01781481|144674318|SUPERIORITY_OR_OTHER||||||>|0.05||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Treatment Experience Item (historical/health system) and Number of Surgeries since child's diagnosis."||||>0.05
72573836|NCT01781481|144674318|SUPERIORITY_OR_OTHER||||||>|0.05||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Treatment Experience Item (historical/health system) and Family Financial Well-Being."||||>0.05
72537876|NCT03692078|144605786|EQUIVALENCE|Null hypothesis: NE amount excreted (mg/24 hour) in Group 6 is equal to zero on Day 7. Alternate hypothesis: NE amount excreted (mg/24 hour) in Group 6 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|-0.85|||<|0.0001|TWO_SIDED|95.0|-1.051|-0.65|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: NE amount excreted (mg/24 hour) in Group 6 is equal to zero on Day 7. Alternate hypothesis: NE amount excreted (mg/24 hour) in Group 6 is NOT equal to zero on Day 7. (mITT Population)||-0.650|-1.051|<.0001
72537877|NCT03692078|144605786|EQUIVALENCE|Null hypothesis: NE amount excreted (mg/24 hour) in Group 2 is equal to Group 1 on Day 5. Alternate hypothesis: NE amount excreted (mg/24 hour) in Group 2 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-0.276||||0.1608|TWO_SIDED|95.0|-0.609|0.057|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: NE amount excreted (mg/24 hour) in Group 2 is equal to Group 1 on Day 5. Alternate hypothesis: NE amount excreted (mg/24 hour) in Group 2 is NOT equal to Group 1 on Day 5. (mITT Population)||0.057|-0.609|0.1608
72537878|NCT03692078|144605786|EQUIVALENCE|Null hypothesis: NE amount excreted (mg/24 hour) in Group 2 is equal to Group 1 on Day 7. Alternate hypothesis: NE amount excreted (mg/24 hour) in Group 2 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-0.278||||0.1575|TWO_SIDED|95.0|-0.613|0.056|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: NE amount excreted (mg/24 hour) in Group 2 is equal to Group 1 on Day 7. Alternate hypothesis: NE amount excreted (mg/24 hour) in Group 2 is NOT equal to Group 1 on Day 7. (mITT Population)||0.056|-0.613|0.1575
72537879|NCT03692078|144605786|EQUIVALENCE|Null hypothesis: NE amount excreted (mg/24 hour) in Group 3 is equal to Group 1 on Day 5. Alternate hypothesis: NE amount excreted (mg/24 hour) in Group 3 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-0.108||||0.9728|TWO_SIDED|95.0|-0.442|0.226|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: NE amount excreted (mg/24 hour) in Group 3 is equal to Group 1 on Day 5. Alternate hypothesis: NE amount excreted (mg/24 hour) in Group 3 is NOT equal to Group 1 on Day 5. (mITT Population)||0.226|-0.442|0.9728
72537880|NCT03692078|144605786|EQUIVALENCE|Null hypothesis: NE amount excreted (mg/24 hour) in Group 3 is equal to Group 1 on Day 7. Alternate hypothesis: NE amount excreted (mg/24 hour) in Group 3 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-0.127||||0.9262|TWO_SIDED|95.0|-0.461|0.208|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: NE amount excreted (mg/24 hour) in Group 3 is equal to Group 1 on Day 7. Alternate hypothesis: NE amount excreted (mg/24 hour) in Group 3 is NOT equal to Group 1 on Day 7. (mITT Population)||0.208|-0.461|0.9262
72537881|NCT03692078|144605786|EQUIVALENCE|Null hypothesis: NE amount excreted (mg/24 hour) in Group 4 is equal to Group 1 on Day 5. Alternate hypothesis: NE amount excreted (mg/24 hour) in Group 4 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-1.584|||<|0.0001|TWO_SIDED|95.0|-1.963|-1.204|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: NE amount excreted (mg/24 hour) in Group 4 is equal to Group 1 on Day 5. Alternate hypothesis: NE amount excreted (mg/24 hour) in Group 4 is NOT equal to Group 1 on Day 5. (mITT Population)||-1.204|-1.963|<.0001
72537882|NCT03692078|144605786|EQUIVALENCE|Null hypothesis: NE amount excreted (mg/24 hour) in Group 4 is equal to Group 1 on Day 7. Alternate hypothesis: NE amount excreted (mg/24 hour) in Group 4 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-1.701|||<|0.0001|TWO_SIDED|95.0|-2.081|-1.32|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: NE amount excreted (mg/24 hour) in Group 4 is equal to Group 1 on Day 7. Alternate hypothesis: NE amount excreted (mg/24 hour) in Group 4 is NOT equal to Group 1 on Day 7. (mITT Population)||-1.320|-2.081|<.0001
72573837|NCT01781481|144674318|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Organization of Care Item (current/health system) and Number of Hospital Services Involved in the Child's Care."||||<0.01
72573838|NCT01781481|144674318|SUPERIORITY_OR_OTHER||||||>|0.05||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Organization of Care Item (current/health system) and Number of Hospitalizations since IBD Diagnosis."||||>0.05
72573839|NCT01781481|144674318|SUPERIORITY_OR_OTHER||||||>|0.05||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Organization of Care Item (current/health system) and Number of Surgeries since Child's IBD Diagnosis."||||>0.05
72409205|NCT02550652|144326857|SUPERIORITY||Difference in Adjusted Mean|0.088|||<|0.0001||95.0|0.052|0.124|||ANCOVA|Stratified by race (Afro Caribbean/African American vs. Others) and region (US vs. non-US sites).||||0.124|0.052|<0.0001
72537883|NCT03692078|144605786|EQUIVALENCE|Null hypothesis: NE amount excreted (mg/24 hour) in Group 5 is equal to Group 1 on Day 5. Alternate hypothesis: NE amount excreted (mg/24 hour) in Group 5 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-0.863|||<|0.0001|TWO_SIDED|95.0|-1.237|-0.489|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: NE amount excreted (mg/24 hour) in Group 5 is equal to Group 1 on Day 5. Alternate hypothesis: NE amount excreted (mg/24 hour) in Group 5 is NOT equal to Group 1 on Day 5. (mITT Population)||-0.489|-1.237|<.0001
72537884|NCT03692078|144605786|EQUIVALENCE|Null hypothesis: NE amount excreted (mg/24 hour) in Group 5 is equal to Group 1 on Day 7. Alternate hypothesis: NE amount excreted (mg/24 hour) in Group 5 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-0.936|||<|0.0001|TWO_SIDED|95.0|-1.312|-0.56|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: NE amount excreted (mg/24 hour) in Group 5 is equal to Group 1 on Day 7. Alternate hypothesis: NE amount excreted (mg/24 hour) in Group 5 is NOT equal to Group 1 on Day 7. (mITT Population)||-0.560|-1.312|<.0001
72537885|NCT03692078|144605788|EQUIVALENCE|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 1 is equal to zero on Day 5. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 1 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|3.47|||<|0.0001|TWO_SIDED|95.0|3.31|3.63|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 1 is equal to zero on Day 5. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 1 is NOT equal to zero on Day 5. (mITT Population)||3.630|3.310|<.0001
72537886|NCT03692078|144605788|EQUIVALENCE|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 1 is equal to zero on Day 7. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 1 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|3.508|||<|0.0001|TWO_SIDED|95.0|3.348|3.668|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 1 is equal to zero on Day 7. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 1 is NOT equal to zero on Day 7. (mITT Population)||3.668|3.348|<.0001
72537887|NCT03692078|144605788|EQUIVALENCE|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 2 is equal to zero on Day 5. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 2 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|2.891|||<|0.0001|TWO_SIDED|95.0|2.741|3.042|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 2 is equal to zero on Day 5. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 2 is NOT equal to zero on Day 5. (mITT Population)||3.042|2.741|<.0001
72537888|NCT03692078|144605788|EQUIVALENCE|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 2 is equal to zero on Day 7. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 2 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|2.873|||<|0.0001|TWO_SIDED|95.0|2.719|3.027|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 2 is equal to zero on Day 7. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 2 is NOT equal to zero on Day 7. (mITT Population)||3.027|2.719|<.0001
72537889|NCT03692078|144605788|EQUIVALENCE|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 3 is equal to zero on Day 5. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 3 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|2.928|||<|0.0001|TWO_SIDED|95.0|2.775|3.082|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 3 is equal to zero on Day 5. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 3 is NOT equal to zero on Day 5. (mITT Population)||3.082|2.775|<.0001
72537890|NCT03692078|144605788|EQUIVALENCE|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 3 is equal to zero on Day 7. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 3 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|2.896|||<|0.0001|TWO_SIDED|95.0|2.742|3.049|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 3 is equal to zero on Day 7. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 3 is NOT equal to zero on Day 7. (mITT Population)||3.049|2.742|<.0001
72573840|NCT01781481|144674318|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Organization of Care Item (current/health system) and Family Financial Well-Being."||||<0.01
72573841|NCT01781481|144674318|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Coordination of Care Item (current/health system) and Number of Hospital Services Involved in the Child's Care."||||<0.01
72409206|NCT02550652|144326857|SUPERIORITY||Difference in Adjusted Mean|0.088|||<|0.0001|TWO_SIDED|80.0|0.065|0.112||"Stratified by race (Afro Caribbean/African American vs. Others) and region (US vs. non-US sites).~Statistically significant at pre-specified alpha of 20%."|ANCOVA|||||0.112|0.065|<0.0001
72369107|NCT00478023|144248219|SUPERIORITY_OR_OTHER_LEGACY||Least square mean difference|18.1|||<|0.0001||95.0|10.9|25.3||Adjusted. The Hochberg procedure used for multiplicity comparisons|ANCOVA|ANCOVA with treatment and centre as fixed effects and baseline pain as covariate.|Only pain intensity assessments collected prior to the first dose of any additional analgesic medication considered. Afterwards LOCF used.|The null hypothesis is that all CG5503 IR dose groups are equal to the placebo group based on the mean sum of pain intensity difference at 24 hours (SPID24). The alternative hypothesis is that at least one CG5503 IR dose group is different from the placebo group based on the mean SPID24.||25.3|10.9|<0.0001
72537891|NCT03692078|144605788|EQUIVALENCE|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 4 is equal to zero on Day 5. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 4 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|0.864|||<|0.0001|TWO_SIDED|95.0|0.672|1.055|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 4 is equal to zero on Day 5. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 4 is NOT equal to zero on Day 5. (mITT Population)||1.055|0.672|<.0001
72537892|NCT03692078|144605788|EQUIVALENCE|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 4 is equal to zero on Day 7. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 4 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|0.786|||<|0.0001|TWO_SIDED|95.0|0.592|0.981|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 4 is equal to zero on Day 7. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 4 is NOT equal to zero on Day 7. (mITT Population)||0.981|0.592|<.0001
72537893|NCT03692078|144605788|EQUIVALENCE|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 5 is equal to zero on Day 5. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 5 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|0.641|||<|0.0001|TWO_SIDED|95.0|0.452|0.829|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 5 is equal to zero on Day 5. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 5 is NOT equal to zero on Day 5. (mITT Population)||0.829|0.452|<.0001
72537894|NCT03692078|144605788|EQUIVALENCE|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 5 is equal to zero on Day 7. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 5 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|0.485|||<|0.0001|TWO_SIDED|95.0|0.29|0.68|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 5 is equal to zero on Day 7. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 5 is NOT equal to zero on Day 7. (mITT Population)||0.680|0.290|<.0001
72537895|NCT03692078|144605788|EQUIVALENCE|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 6 is equal to zero on Day 5. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 6 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|0.747|||<|0.0001|TWO_SIDED|95.0|0.562|0.932|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 6 is equal to zero on Day 5. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 6 is NOT equal to zero on Day 5. (mITT Population)||0.932|0.562|<.0001
72537896|NCT03692078|144605788|EQUIVALENCE|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 6 is equal to zero on Day 7. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 6 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|0.833|||<|0.0001|TWO_SIDED|95.0|0.645|1.021|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 6 is equal to zero on Day 7. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 6 is NOT equal to zero on Day 7. (mITT Population)||1.021|0.645|<.0001
72573842|NCT01781481|144674318|SUPERIORITY_OR_OTHER||||||>|0.05||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Coordination of Care Item (current/health system) and Number of Hospitalizations since Child's IBD Diagnosis."||||>0.05
72573843|NCT01781481|144674318|SUPERIORITY_OR_OTHER||||||>|0.05||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Coordination of Care Item (current/health system) and Number of Surgeries Child's IBD Diagnosis."||||>0.05
72573844|NCT01781481|144674318|SUPERIORITY_OR_OTHER||||||>|0.05||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Coordination of Care Item (current/health system) and Family Financial Well Being."||||>0.05
72573845|NCT01781481|144674318|SUPERIORITY_OR_OTHER||||||>|0.05||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Health System Impediments Item (vulnerability/health system) and Number of Hospital Services Involved in the Child's Care."||||>0.05
72573846|NCT01781481|144674318|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Health System Impediments Item (vulnerability/health system) and Number of Hospitalizations since Child's IBD Diagnosis. Services Involved in the Child's Care."||||<0.01
72573847|NCT01781481|144674318|SUPERIORITY_OR_OTHER||||||>|0.05||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Health System Impediments Item (vulnerability/health system) and Number of Surgeries since Child's IBD Diagnosis."||||>0.05
72573848|NCT01781481|144674318|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Health System Impediments Item (vulnerability/health system) and Family Financial Well-Being."||||<0.01
72627017|NCT01405196|144783262|SUPERIORITY||Odds Ratio (OR)|0.74|||||TWO_SIDED|90.0|0.3|1.84||||||Week 16: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.||1.84|0.30|
72627018|NCT01405196|144783262|SUPERIORITY||Odds Ratio (OR)|1.78|||||TWO_SIDED|90.0|0.72|4.37||||||Week 20: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.||4.37|0.72|
72627019|NCT01405196|144783262|SUPERIORITY||Odds Ratio (OR)|1.21|||||TWO_SIDED|90.0|0.5|2.92||||||Week 20: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.||2.92|0.50|
72627020|NCT01405196|144783262|SUPERIORITY||Odds Ratio (OR)|2.22|||||TWO_SIDED|90.0|0.89|5.55||||||Week 24: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.||5.55|0.89|
72627021|NCT01405196|144783262|SUPERIORITY||Odds Ratio (OR)|1.0|||||TWO_SIDED|90.0|0.4|2.46||||||Week 24: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.||2.46|0.40|
72627022|NCT01405196|144783263|SUPERIORITY||Odds Ratio (OR)|1.34|||||TWO_SIDED|90.0|0.53|3.35||||||Week 4: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.||3.35|0.53|
72409207|NCT02550652|144326858|SUPERIORITY||Difference in Percentage of Participants|13.9||||0.09||95.0|-2.4|30.1||"Stratified by race (Afro Caribbean/African American vs. Others) and region (US vs. non-US sites).~Statistically significant at pre-specified alpha of 20%"|Cochran-Mantel-Haenszel|||||30.1|-2.4|0.0900
72537897|NCT03692078|144605788|EQUIVALENCE|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 2 is equal to Group 1 on Day 5. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 2 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-0.579|||<|0.0001|TWO_SIDED|95.0|-0.889|-0.268|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 2 is equal to Group 1 on Day 5. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 2 is NOT equal to Group 1 on Day 5. (mITT Population)||-0.268|-0.889|<.0001
72573849|NCT01781481|144674319|SUPERIORITY_OR_OTHER||Rsquare change statistic|0.08|||<|0.01|TWO_SIDED|||||p\<0.05 Threshold for statistical significance|Regression, Linear|||A hierarchical multiple (linear) regression analysis was conducted to determine the predictive relation between the Pediatric INTERMED indicator of case complexity and the number of hospital services involved in child's care. Gender, and time since diagnosis were entered as covariates (Step 1), followed by current disease severity (Step 2) and the Pediatric INTERMED Complexity Index (Step 3). Diagnostic tests for collinearity were conducted and all assumptions for the analysis were met.||||<0.01
72573850|NCT01781481|144674320|SUPERIORITY_OR_OTHER||R2Change|0.05|||<|0.01|TWO_SIDED|||||Threshold for statistical significance is p\<0.01|Regression, Linear|||A hierarchical multiple (linear) regression analysis was conducted to determine the predictive relation between the Pediatric INTERMED indicator of case complexity and the number of calls to the IBD Nurse. Gender, and time since diagnosis were entered as covariates (Step 1), followed by current disease severity (Step 2) and the Pediatric INTERMED Complexity Index (Step 3). Diagnostic tests for collinearity were conducted and all assumptions for the analysis were met.||||<0.01
72573851|NCT01781481|144674321|SUPERIORITY_OR_OTHER||Rsquare change statistic|0.05|||<|0.01|TWO_SIDED|||||p\<.05 threshold for statistical significance|Regression, Linear|Diagnostic tests for collinearity were conducted and all assumptions for the analysis were met.||A hierarchical multiple (linear) regression analysis was conducted to determine the predictive relation between the Pediatric INTERMED indicator of case complexity and the number of extra appointments with the IBD team. Gender, and time since diagnosis were entered as covariates (Step 1), followed by current disease severity (Step 2) and the Pediatric INTERMED Complexity Index (Step 3).||||<0.01
72573852|NCT01781481|144674322|SUPERIORITY_OR_OTHER||R2Change|0.03|||<|0.05|TWO_SIDED|||||Threshold for statistical significance is p \<0.05.|Regression, Linear|||A hierarchical multiple (linear) regression analysis was conducted to determine the predictive relation between the Pediatric INTERMED indicator of case complexity and the number of ER Visits. Gender, and time since diagnosis were entered as covariates (Step 1), followed by current disease severity (Step 2) and the Pediatric INTERMED Complexity Index (Step 3). Diagnostic tests for collinearity were conducted and all assumptions for the analysis were met.||||<0.05
72627023|NCT01405196|144783263|SUPERIORITY||Odds Ratio (OR)|1.04|||||TWO_SIDED|90.0|0.41|2.65||||||Week 4: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.||2.65|0.41|
72627024|NCT01405196|144783263|SUPERIORITY||Odds Ratio (OR)|0.81|||||TWO_SIDED|90.0|0.33|1.96||||||Week 8: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.||1.96|0.33|
72627025|NCT01405196|144783263|SUPERIORITY||Odds Ratio (OR)|0.93|||||TWO_SIDED|90.0|0.39|2.23||||||Week 8: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.||2.23|0.39|
72627026|NCT01405196|144783263|SUPERIORITY||Odds Ratio (OR)|1.01|||||TWO_SIDED|90.0|0.42|2.45||||||Week 12: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.||2.45|0.42|
72409208|NCT02550652|144326858|SUPERIORITY||Difference in Percentage of Participants|13.9||||0.09|TWO_SIDED|80.0|3.2|24.5||"Stratified by race (Afro Caribbean/African American vs. Others) and region (US vs. non-US sites).~Statistically significant at pre-specified alpha of 20%"|Cochran-Mantel-Haenszel|||||24.5|3.2|0.0900
72537898|NCT03692078|144605788|EQUIVALENCE|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 2 is equal to Group 1 on Day 7. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 2 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-0.635|||<|0.0001|TWO_SIDED|95.0|-0.949|-0.321|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 2 is equal to Group 1 on Day 7. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 2 is NOT equal to Group 1 on Day 7. (mITT Population)||-0.321|-0.949|<.0001
72537899|NCT03692078|144605788|EQUIVALENCE|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 3 is equal to Group 1 on Day 5. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 3 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-0.542|||<|0.0001|TWO_SIDED|95.0|-0.853|-0.231|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 3 is equal to Group 1 on Day 5. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 3 is NOT equal to Group 1 on Day 5. (mITT Population)||-0.231|-0.853|<.0001
72537900|NCT03692078|144605788|EQUIVALENCE|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 3 is equal to Group 1 on Day 7. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 3 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-0.613|||<|0.0001|TWO_SIDED|95.0|-0.924|-0.301|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 3 is equal to Group 1 on Day 7. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 3 is NOT equal to Group 1 on Day 7. (mITT Population)||-0.301|-0.924|<.0001
72537901|NCT03692078|144605788|EQUIVALENCE|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 4 is equal to Group 1 on Day 5. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 4 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-2.606|||<|0.0001|TWO_SIDED|95.0|-2.959|-2.253|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 4 is equal to Group 1 on Day 5. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 4 is NOT equal to Group 1 on Day 5. (mITT Population)||-2.253|-2.959|<.0001
72537902|NCT03692078|144605788|EQUIVALENCE|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 4 is equal to Group 1 on Day 7. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 4 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-2.722|||<|0.0001|TWO_SIDED|95.0|-3.078|-2.366|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 4 is equal to Group 1 on Day 7. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 4 is NOT equal to Group 1 on Day 7. (mITT Population)||-2.366|-3.078|<.0001
72537903|NCT03692078|144605788|EQUIVALENCE|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 5 is equal to Group 1 on Day 5. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 5 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-2.829|||<|0.0001|TWO_SIDED|95.0|-3.177|-2.481|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 5 is equal to Group 1 on Day 5. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 5 is NOT equal to Group 1 on Day 5. (mITT Population)||-2.481|-3.177|<.0001
72573853|NCT01781481|144674323|SUPERIORITY_OR_OTHER||R2Change|0.07|||<|0.01|TWO_SIDED||||||Regression, Linear|||A hierarchical multiple (linear) regression analysis was conducted to determine the predictive relation between the Pediatric INTERMED indicator of case complexity and the number of hospital services involved in child's care. Gender, and time since diagnosis were entered as covariates (Step 1), followed by current disease severity (Step 2) and the Pediatric INTERMED Complexity Index (Step 3). Diagnostic tests for collinearity were conducted and all assumptions for the analysis were met.||||<0.01
72573854|NCT01955837|144674352|SUPERIORITY||Hazard Ratio (HR)|0.79||||0.035|TWO_SIDED|95.0|0.62|0.99|||Log Rank|||||0.99|0.62|0.035
72573855|NCT01955837|144674353|SUPERIORITY||Hazard Ratio (HR)|0.43|||<|0.001|TWO_SIDED|95.0|0.34|0.54|||Log Rank|||||0.54|0.34|<0.001
72573856|NCT01955837|144674354|SUPERIORITY||Hazard Ratio (HR)|0.46|||<|0.001|TWO_SIDED|95.0|0.37|0.58|||Log Rank|||||0.58|0.37|<0.001
72627027|NCT01405196|144783263|SUPERIORITY||Odds Ratio (OR)|1.31|||||TWO_SIDED|90.0|0.55|3.1||||||Week 12: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.||3.10|0.55|
72627028|NCT01405196|144783263|SUPERIORITY||Odds Ratio (OR)|2.36|||||TWO_SIDED|90.0|0.95|5.88||||||Week 16: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.||5.88|0.95|
72627029|NCT01405196|144783263|SUPERIORITY||Odds Ratio (OR)|1.82|||||TWO_SIDED|90.0|0.74|4.46||||||Week 16: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.||4.46|0.74|
72627030|NCT01405196|144783263|SUPERIORITY||Odds Ratio (OR)|2.8|||||TWO_SIDED|90.0|1.1|7.12||||||Week 20: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.||7.12|1.10|
72627031|NCT01405196|144783263|SUPERIORITY||Odds Ratio (OR)|1.67|||||TWO_SIDED|90.0|0.66|4.21||||||Week 20: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.||4.21|0.66|
72409209|NCT02550652|144326859|SUPERIORITY||Difference in Percentage of Participants|10.6||||0.1838|TWO_SIDED|95.0|-6.4|27.6||"Stratified by race (Afro Caribbean/African American vs. Others) and region (US vs. non-US sites).~Statistically significant at pre-specified alpha of 20%"|Cochran-Mantel-Haenszel|||||27.6|-6.4|0.1838
72537904|NCT03692078|144605788|EQUIVALENCE|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 5 is equal to Group 1 on Day 7. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 5 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-3.024|||<|0.0001|TWO_SIDED|95.0|-3.378|-2.669|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 5 is equal to Group 1 on Day 7. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 5 is NOT equal to Group 1 on Day 7. (mITT Population)||-2.669|-3.378|<.0001
72537905|NCT03692078|144605788|EQUIVALENCE|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 2 is equal to Group 6 on Day 5. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 2 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|2.144|||<|0.0001|TWO_SIDED|95.0|1.811|2.478|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 2 is equal to Group 6 on Day 5. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 2 is NOT equal to Group 6 on Day 5. (mITT Population)||2.478|1.811|<.0001
72537906|NCT03692078|144605788|EQUIVALENCE|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 2 is equal to Group 6 on Day 7. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 2 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|2.04|||<|0.0001|TWO_SIDED|95.0|1.701|2.379|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 2 is equal to Group 6 on Day 7. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 2 is NOT equal to Group 6 on Day 7. (mITT Population)||2.379|1.701|<.0001
72537907|NCT03692078|144605788|EQUIVALENCE|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 3 is equal to Group 6 on Day 5. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 3 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|2.181|||<|0.0001|TWO_SIDED|95.0|1.846|2.516|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 3 is equal to Group 6 on Day 5. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 3 is NOT equal to Group 6 on Day 5. (mITT Population)||2.516|1.846|<.0001
72537908|NCT03692078|144605788|EQUIVALENCE|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 3 is equal to Group 6 on Day 7. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 3 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|2.063|||<|0.0001|TWO_SIDED|95.0|1.725|2.4|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 3 is equal to Group 6 on Day 7. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 3 is NOT equal to Group 6 on Day 7. (mITT Population)||2.400|1.725|<.0001
72537909|NCT03692078|144605788|EQUIVALENCE|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 4 is equal to Group 6 on Day 5. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 4 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|0.117||||0.9705|TWO_SIDED|95.0|-0.256|0.49|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 4 is equal to Group 6 on Day 5. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 4 is NOT equal to Group 6 on Day 5. (mITT Population)||0.490|-0.256|0.9705
72537910|NCT03692078|144605788|EQUIVALENCE|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 4 is equal to Group 6 on Day 7. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 4 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|-0.047||||1|TWO_SIDED|95.0|-0.425|0.332|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 4 is equal to Group 6 on Day 7. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 4 is NOT equal to Group 6 on Day 7. (mITT Population)||0.332|-0.425|1.0000
72573857|NCT01955837|144674355|SUPERIORITY||Difference in ORR|1.1||||0.554|TWO_SIDED|95.0|-0.1|2.4|||Fisher Exact|||||2.4|-0.1|0.554
72573858|NCT01955837|144674356|SUPERIORITY||Difference in DCR|29.4|||<|0.001|TWO_SIDED|95.0|20.9|38.0|||Fisher Exact|||||38.0|20.9|<0.001
72573859|NCT01955837|144674357|SUPERIORITY||Odds Ratio (OR)|29.4|||<|0.001|TWO_SIDED|95.0|20.9|38.0|||Fisher Exact|||||38.0|20.9|<0.001
72573860|NCT01955837|144674360|SUPERIORITY||Hazard Ratio (HR)|0.77||||0.083|TWO_SIDED|95.0|0.57|1.04|||Log Rank|||||1.04|0.57|0.083
72573861|NCT01955837|144674361|SUPERIORITY||Hazard Ratio (HR)|0.83||||0.228|TWO_SIDED|95.0|0.57|1.2|||Log Rank|||||1.20|0.57|0.228
72573862|NCT01955837|144674362|SUPERIORITY||Hazard Ratio (HR)|0.44|||||TWO_SIDED|95.0|0.32|0.59||||||||0.59|0.32|
72409210|NCT02550652|144326859|SUPERIORITY||Difference in Percentage of Participants|10.6||||0.1838|TWO_SIDED|80.0|-0.5|21.7||"Stratified by race (Afro Caribbean/African American vs. Others) and region (US vs. non-US sites).~Statistically significant at pre-specified alpha of 20%"|Cochran-Mantel-Haenszel|||||21.7|-0.5|0.1838
72409211|NCT02550652|144326860|SUPERIORITY||Difference in Percentage of Participants|7.3||||0.3726|TWO_SIDED|95.0|-10.0|24.6||"Stratified by race (Afro Caribbean/African American vs. Others) and region (US vs. non-US sites).~Statistically significant at pre-specified alpha of 20%."|Cochran-Mantel-Haenszel|||||24.6|-10.0|0.3726
72627032|NCT01405196|144783263|SUPERIORITY||Odds Ratio (OR)|2.95|||||TWO_SIDED|90.0|1.18|7.41||||||Week 24: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.||7.41|1.18|
72627033|NCT01405196|144783263|SUPERIORITY||Odds Ratio (OR)|2.03|||||TWO_SIDED|90.0|0.82|5.06||||||Week 24: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.||5.06|0.82|
72409212|NCT02550652|144326860|SUPERIORITY||Difference in Percentage of Participants|7.3||||0.3726|TWO_SIDED|80.0|-4.0|18.6||"Stratified by race (Afro Caribbean/African American vs. Others) and region (US vs. non-US sites).~Statistically significant at pre-specified alpha of 20%"|Cochran-Mantel-Haenszel|||||18.6|-4.0|0.3726
72537911|NCT03692078|144605788|EQUIVALENCE|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 5 is equal to Group 6 on Day 5. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 5 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|-0.106||||0.9835|TWO_SIDED|95.0|-0.475|0.263|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 5 is equal to Group 6 on Day 5. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 5 is NOT equal to Group 6 on Day 5. (mITT Population)||0.263|-0.475|0.9835
72537912|NCT03692078|144605788|EQUIVALENCE|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 5 is equal to Group 6 on Day 7. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 5 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|-0.348||||0.0854|TWO_SIDED|95.0|-0.725|0.029|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 5 is equal to Group 6 on Day 7. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 5 is NOT equal to Group 6 on Day 7. (mITT Population)||0.029|-0.725|0.0854
72537913|NCT03692078|144605790|EQUIVALENCE|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 1 is equal to zero on Day 5. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 1 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|3.028|||<|0.0001|TWO_SIDED|95.0|2.901|3.154|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 1 is equal to zero on Day 5. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 1 is NOT equal to zero on Day 5. (mITT Population)||3.154|2.901|<.0001
72537914|NCT03692078|144605790|EQUIVALENCE|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 1 is equal to zero on Day 7. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 1 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|3.034|||<|0.0001|TWO_SIDED|95.0|2.927|3.141|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 1 is equal to zero on Day 7. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 1 is NOT equal to zero on Day 7. (mITT Population)||3.141|2.927|<.0001
72537915|NCT03692078|144605790|EQUIVALENCE|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 2 is equal to zero on Day 5. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 2 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|2.603|||<|0.0001|TWO_SIDED|95.0|2.483|2.722|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 2 is equal to zero on Day 5. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 2 is NOT equal to zero on Day 5. (mITT Population)||2.722|2.483|<.0001
72537916|NCT03692078|144605790|EQUIVALENCE|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 2 is equal to zero on Day 7. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 2 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|2.567|||<|0.0001|TWO_SIDED|95.0|2.465|2.67|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 2 is equal to zero on Day 7. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 2 is NOT equal to zero on Day 7. (mITT Population)||2.670|2.465|<.0001
72537917|NCT03692078|144605790|EQUIVALENCE|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 3 is equal to zero on Day 5. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 3 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|2.716|||<|0.0001|TWO_SIDED|95.0|2.595|2.838|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 3 is equal to zero on Day 5. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 3 is NOT equal to zero on Day 5. (mITT Population)||2.838|2.595|<.0001
72537918|NCT03692078|144605790|EQUIVALENCE|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 3 is equal to zero on Day 7. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 3 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|2.643|||<|0.0001|TWO_SIDED|95.0|2.541|2.746|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 3 is equal to zero on Day 7. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 3 is NOT equal to zero on Day 7. (mITT Population)||2.746|2.541|<.0001
72409213|NCT01706250|144326871|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.29|STANDARD_DEVIATION|32.98||0.6779|||||||t-test, 2 sided|||Percent change for IL count for MAXCLARITY II Vs PROACTIV at Wk 8||||0.6779
72409214|NCT01706250|144326871|SUPERIORITY_OR_OTHER||Median Difference (Net)|7.68|STANDARD_DEVIATION|29.51||0.2847|||||||t-test, 2 sided|||Percent change for NIL count for MAXCLARITY II Vs PROACTIV at Wk 8||||0.2847
72537919|NCT03692078|144605790|EQUIVALENCE|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 4 is equal to zero on Day 5. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 4 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|1.235|||<|0.0001|TWO_SIDED|95.0|1.083|1.386|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 4 is equal to zero on Day 5. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 4 is NOT equal to zero on Day 5. (mITT Population)||1.386|1.083|<.0001
72537920|NCT03692078|144605790|EQUIVALENCE|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 4 is equal to zero on Day 7. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 4 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|1.174|||<|0.0001|TWO_SIDED|95.0|1.045|1.304|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 4 is equal to zero on Day 7. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 4 is NOT equal to zero on Day 7. (mITT Population)||1.304|1.045|<.0001
72627034|NCT01405196|144783264|SUPERIORITY||Odds Ratio (OR)|1.59||||0.205|TWO_SIDED|90.0|0.63|4.02||P-value was displayed without adjusting for multiplicity.|Mixed Models Analysis|||\>=4 points reduction in SLEDAI score: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.||4.02|0.63|0.205
72627035|NCT01405196|144783264|SUPERIORITY||Odds Ratio (OR)|0.84||||0.625|TWO_SIDED|90.0|0.34|2.08||P-value was displayed without adjusting for multiplicity.|Mixed Models Analysis|||\>=4 points reduction in SLEDAI score: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.||2.08|0.34|0.625
72409215|NCT01706250|144326871|SUPERIORITY_OR_OTHER||Median Difference (Net)|2.24|STANDARD_DEVIATION|23.35||0.6894|||||||t-test, 2 sided|||Percent change for TL count for MAXCLARITY II Vs PROACTIV at Wk 8||||0.6894
72537921|NCT03692078|144605790|EQUIVALENCE|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 5 is equal to zero on Day 5. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 5 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|1.219|||<|0.0001|TWO_SIDED|95.0|1.07|1.368|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 5 is equal to zero on Day 5. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 5 is NOT equal to zero on Day 5. (mITT Population)||1.368|1.070|<.0001
72573863|NCT01955837|144674363|SUPERIORITY||Hazard Ratio (HR)|0.45|||||TWO_SIDED|95.0|0.31|0.65||||||||0.65|0.31|
72573864|NCT00552578|144674364|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.17||||0.523||95.0|0.0098|2.8215|||Fisher Exact|||Intent to treat||2.8215|0.0098|0.523
72573865|NCT00552578|144674366|SUPERIORITY_OR_OTHER|||||||0.015||95.0||||No adjustment|Fisher Exact|||Fisher exact test was used and tested the hypothesis that neither group would be more likely to complete the study protocol.||||0.015
72573866|NCT00626392|144674376|SUPERIORITY_OR_OTHER|||||||0.01||95.0||||No adjustments were made for multiple comparisons. P-values \<= 0.05 were reported as statistically significant.|Cochran-Mantel-Haenszel|||||||0.010
72573867|NCT00392236|144674393|SUPERIORITY_OR_OTHER|||||||0.083|||||||ANOVA|||||||0.083
72573868|NCT03275064|144674413|SUPERIORITY||Mean Difference (Net)|0.48|||||TWO_SIDED|90.0|-30.73|31.69|||Mixed Models Analysis|||Week 16||31.69|-30.73|
72627036|NCT01405196|144783264|SUPERIORITY||Odds Ratio (OR)|2.81||||0.198|TWO_SIDED|90.0|0.38|20.65||P-value was displayed without adjusting for multiplicity.|Mixed Models Analysis|||No worsening in PhGA: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.||20.65|0.38|0.198
72573869|NCT03275064|144674413|SUPERIORITY||Mean Difference (Net)|3.68|||||TWO_SIDED|90.0|-27.04|34.4|||Mixed Models Analysis|||Week 28||34.40|-27.04|
72409216|NCT01706250|144326872|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.38|STANDARD_DEVIATION|50.1||0.9909|||||||Signed Rank|||Percent change for MAXCLARITY II Vs PROACTIV: IL count, BL to Wk 1 (within group)||||0.9909
72409217|NCT01706250|144326872|SUPERIORITY_OR_OTHER||Median Difference (Net)|-4.0|STANDARD_DEVIATION|39.91||0.6671|||||||t-test, 2 sided|||IL count for MAXCLARITY II Vs PROACTIV- BL to Wk 2 (within group)||||0.6671
72409218|NCT01706250|144326872|SUPERIORITY_OR_OTHER||Median Difference (Net)|23.64|STANDARD_DEVIATION|52.05||0.0632|||||||t-test, 2 sided|||Percent change for MAXCLARITY II Vs PROACTIV: IL count, BL to Wk 4 (within group)||||0.0632
72409219|NCT01706250|144326873|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.2|STANDARD_DEVIATION|42.31||0.7385|||||||t-test, 2 sided|||Percent change for MAXCLARITY II Vs PROACTIV: NIL count, BL to Wk 1 (within group)||||0.7385
72409220|NCT01706250|144326873|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.04|STANDARD_DEVIATION|37.77||0.7296|||||||t-test, 2 sided|||Percent change for MAXCLARITY II Vs PROACTIV: NIL count, BL to Wk 2 (within group)||||0.7296
72409221|NCT01706250|144326873|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.5|STANDARD_DEVIATION|36.11||0.3774|||||||t-test, 2 sided|||Percent change for MAXCLARITY II Vs PROACTIV: NIL count, BL to Wk 4 (within group)||||0.3774
72573870|NCT03275064|144674414|SUPERIORITY||Mean Difference (Final Values)|1.69|||||TWO_SIDED|90.0|-27.7|31.08|||Mixed Models Analysis|||Week 16||31.08|-27.70|
72573871|NCT03275064|144674414|SUPERIORITY||Mean Difference (Net)|5.97|||||TWO_SIDED|90.0|-23.03|34.97|||Mixed Models Analysis|||Week 28||34.97|-23.03|
72573872|NCT03275064|144674415|SUPERIORITY||Mean Difference (Net)|0.88|||||TWO_SIDED|90.0|-47.27|49.04|||Mixed Models Analysis|||Week 16||49.04|-47.27|
72537922|NCT03692078|144605790|EQUIVALENCE|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 5 is equal to zero on Day 7. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 5 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|1.176|||<|0.0001|TWO_SIDED|95.0|1.046|1.306|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 5 is equal to zero on Day 7. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 5 is NOT equal to zero on Day 7. (mITT Population)||1.306|1.046|<.0001
72537923|NCT03692078|144605790|EQUIVALENCE|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 6 is equal to zero on Day 5. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 6 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|1.176|||<|0.0001|TWO_SIDED|95.0|1.029|1.322|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 6 is equal to zero on Day 5. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 6 is NOT equal to zero on Day 5. (mITT Population)||1.322|1.029|<.0001
72537924|NCT03692078|144605790|EQUIVALENCE|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 6 is equal to zero on Day 7. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 6 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|1.174|||<|0.0001|TWO_SIDED|95.0|1.049|1.3|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 6 is equal to zero on Day 7. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 6 is NOT equal to zero on Day 7. (mITT Population)||1.300|1.049|<.0001
72537925|NCT03692078|144605790|EQUIVALENCE|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 2 is equal to Group 1 on Day 5. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 2 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-0.425|||<|0.0001|TWO_SIDED|95.0|-0.669|-0.181|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 2 is equal to Group 1 on Day 5. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 2 is NOT equal to Group 1 on Day 5. (mITT Population)||-0.181|-0.669|<.0001
72573873|NCT03275064|144674415|SUPERIORITY||Mean Difference (Net)|2.27|||||TWO_SIDED|90.0|-43.11|47.65|||Mixed Models Analysis|||Week 28||47.65|-43.11|
72573874|NCT03275064|144674416|SUPERIORITY|Week 29|Mean Difference (Net)|200.18||||0.0131|TWO_SIDED|90.0|54.53|345.83|||Mixed Models Analysis|||||345.83|54.53|0.0131
72573875|NCT03275064|144674416|SUPERIORITY||Mean Difference (Net)|141.87||||0.0544|TWO_SIDED|90.0|-3.83|287.56|||Mixed Models Analysis|||Week 29||287.56|-3.83|0.0544
72409222|NCT01706250|144326874|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.02|STANDARD_DEVIATION|29.53||0.7634|||||||t-test, 2 sided|||Percent change for MAXCLARITY II Vs PROACTIV: TL count, BL to Wk 1 (within group)||||0.7634
72409223|NCT01706250|144326874|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.75|STANDARD_DEVIATION|29.61||0.4087|||||||t-test, 2 sided|||Percent change for MAXCLARITY II Vs PROACTIV: TL count, BL to Wk 2 (within group)||||0.4087
72573876|NCT03275064|144674416|SUPERIORITY||Mean Difference (Net)|228.27||||0.0067|TWO_SIDED|90.0|80.87|375.67|||Mixed Models Analysis|||Week 53||375.67|80.87|0.0067
72409224|NCT01706250|144326874|SUPERIORITY_OR_OTHER||Mean Difference (Net)|7.0|STANDARD_DEVIATION|25.4||0.2455|||||||t-test, 2 sided|||Percent change for MAXCLARITY II Vs PROACTIV: TL count, BL to Wk 4 (within group)||||0.2455
72573877|NCT03275064|144674416|SUPERIORITY||Mean Difference (Net)|116.21||||0.0931|TWO_SIDED|90.0|-29.52|261.94|||Mixed Models Analysis|||Week 53||261.94|-29.52|0.0931
72573878|NCT03275064|144674417|SUPERIORITY||Mean Difference (Net)|0.05||||0.0574|TWO_SIDED|90.0|0.0|0.1|||Mixed Models Analysis|||Week 29||0.10|-0.00|0.0574
72573879|NCT03275064|144674417|SUPERIORITY||Mean Difference (Net)|0.06||||0.0248|TWO_SIDED|90.0|0.01|0.11|||Mixed Models Analysis|||Week 29||0.11|0.01|0.0248
72573880|NCT03275064|144674417|SUPERIORITY||Mean Difference (Net)|0.01||||0.3864|TWO_SIDED|90.0|-0.05|0.07|||Mixed Models Analysis|||Week 53||0.07|-0.05|0.3864
72573881|NCT03275064|144674417|SUPERIORITY||Mean Difference (Net)|0.02||||0.329|TWO_SIDED|90.0|-0.05|0.08|||Mixed Models Analysis|||Week 53||0.08|-0.05|0.3290
72573882|NCT03275064|144674418|SUPERIORITY||Mean Difference (Net)|4.75||||0.6184|TWO_SIDED|90.0|-21.36|30.85|||Mixed Models Analysis|||Week 16||30.85|-21.36|0.6184
72573883|NCT03275064|144674418|OTHER||Mean Difference (Net)|-7.32||||0.3194|TWO_SIDED|90.0|-33.16|18.53|||Mixed Models Analysis|||Week 28||18.53|-33.16|0.3194
72573884|NCT03275064|144674419|SUPERIORITY||Mean Difference (Net)|3.38|||||TWO_SIDED|90.0|-1.72|8.47|||Mixed Models Analysis|||Week 29||8.47|-1.72|
72573885|NCT03275064|144674419|SUPERIORITY||Mean Difference (Net)|-0.1|||||TWO_SIDED|90.0|-5.22|5.01|||Mixed Models Analysis|||Week 29||5.01|-5.22|
72627037|NCT01405196|144783264|SUPERIORITY||Odds Ratio (OR)|2.88||||0.192|TWO_SIDED|90.0|0.39|21.3||P-value was displayed without adjusting for multiplicity.|Mixed Models Analysis|||No worsening in PhGA: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.||21.30|0.39|0.192
72409225|NCT01706250|144326875|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.05|STANDARD_DEVIATION|0.39||1|||||||Signed Rank|||Change, in ISGA for MAXCLARITY II Vs PROACTIV: from BL to Wk 1 (within group)||||1.0000
72409226|NCT01706250|144326875|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.26|STANDARD_DEVIATION|0.56||0.125|||||||Signed Rank|||Change, in ISGA for MAXCLARITY II Vs PROACTIV: from BL to Wk 2 (within group)||||0.1250
72409227|NCT01706250|144326875|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.11|STANDARD_DEVIATION|0.46||0.625|||||||Signed Rank|||Change, in ISGA for MAXCLARITY II Vs PROACTIV: from BL to Wk 4 (within group)||||0.6250
72409228|NCT01706250|144326875|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0|STANDARD_DEVIATION|0.59||1|||||||Signed Rank|||Change, in ISGA for MAXCLARITY II Vs PROACTIV: from BL to Wk 8 (within group)||||1.0000
72573886|NCT03275064|144674419|SUPERIORITY||Mean Difference (Net)|-1.14|||||TWO_SIDED|90.0|-6.42|4.15|||Mixed Models Analysis|||Week 53||4.15|-6.42|
72573887|NCT03275064|144674419|SUPERIORITY||Mean Difference (Net)|-7.44|||||TWO_SIDED|90.0|-12.68|-2.2|||Mixed Models Analysis|||Week 53||-2.20|-12.68|
72573888|NCT03275064|144674420|SUPERIORITY||Mean Difference (Net)|2.09|||||TWO_SIDED|90.0|-3.49|7.66|||Mixed Models Analysis|||Week 29||7.66|-3.49|
72573889|NCT03275064|144674420|SUPERIORITY||Mean Difference (Net)|0.82|||||TWO_SIDED|90.0|-4.82|6.45|||Mixed Models Analysis|||Week 29||6.45|-4.82|
72573890|NCT03275064|144674420|SUPERIORITY||Mean Difference (Net)|2.29|||||TWO_SIDED|90.0|-3.54|8.11|||Mixed Models Analysis|||Week 53||8.11|-3.54|
72573891|NCT03275064|144674420|SUPERIORITY||Mean Difference (Net)|-5.96|||||TWO_SIDED|90.0|-11.81|-0.1|||Mixed Models Analysis|||Week 53||-0.10|-11.81|
72573892|NCT03275064|144674421|SUPERIORITY||Mean Difference (Net)|3.47|||||TWO_SIDED|90.0|-2.21|9.15|||Mixed Models Analysis|||Week 29||9.15|-2.21|
72573893|NCT03275064|144674421|SUPERIORITY||Mean Difference (Net)|-0.63|||||TWO_SIDED|90.0|-6.31|5.04|||Mixed Models Analysis|||Week 29||5.04|-6.31|
72573894|NCT03275064|144674421|SUPERIORITY||Mean Difference (Net)|-2.63|||||TWO_SIDED|90.0|-8.07|2.82|||Mixed Models Analysis|||Week 53||2.82|-8.07|
72573895|NCT03275064|144674421|SUPERIORITY||Mean Difference (Net)|-8.16|||||TWO_SIDED|90.0|-13.61|-2.72|||Mixed Models Analysis|||Week 53||-2.72|-13.61|
72573896|NCT04159935|144674433|OTHER|||||||0.4|||||||Wilcoxon (Mann-Whitney)|||||||0.400
72573897|NCT04159935|144674434|OTHER|||||||0.057|||||||Wilcoxon (Mann-Whitney)|||||||0.057
72573898|NCT04159935|144674435|OTHER|||||||1|||||||Wilcoxon (Mann-Whitney)|||||||1.000
72573899|NCT04159935|144674437|OTHER|||||||0.4|||||||Wilcoxon (Mann-Whitney)|||||||0.400
72573900|NCT04159935|144674438|OTHER|||||||0.4|||||||Wilcoxon (Mann-Whitney)|||||||0.400
72573901|NCT04159935|144674439|OTHER|||||||0.5|||||||Wilcoxon (Mann-Whitney)|||||||0.500
72573902|NCT04159935|144674440|OTHER|||||||1|||||||Wilcoxon (Mann-Whitney)|||||||1.00
72573903|NCT04159935|144674441|OTHER|||||||0.4|||||||Wilcoxon (Mann-Whitney)|||||||0.400
72573904|NCT04159935|144674443|OTHER|||||||0.343|||||||Wilcoxon (Mann-Whitney)|||||||0.343
72573905|NCT04159935|144674444|OTHER|||||||0.7|||||||Wilcoxon (Mann-Whitney)|||||||0.700
72573906|NCT04159935|144674445|OTHER|||||||0.5|||||||Wilcoxon (Mann-Whitney)|||||||0.500
72573907|NCT00724048|144674459|SUPERIORITY||Mean Difference (Final Values)|-1.17||||0.078|TWO_SIDED|95.0|-2.47|0.13|||ANCOVA|||The ANCOVA model included a term for treatment, as well as covariates for baseline mMS, and age at entry to the study.||0.13|-2.47|0.078
72573908|NCT00724048|144674459|SUPERIORITY||Mean Difference (Final Values)|-1.19||||0.084|TWO_SIDED|95.0|-2.53|0.16||Hypothesis testing was completed only if ACR16 45 mg BID (90 mg) vs. placebo was significant.|ANCOVA|||The ANCOVA model included a term for treatment, as well as covariates for baseline mMS, and age at entry to the study.||0.16|-2.53|0.084
72573909|NCT00724048|144674459|SUPERIORITY||Mean Difference (Final Values)|-0.02||||0.982|TWO_SIDED|95.0|-1.35|1.32||Hypothesis testing was completed only if ACR16 22.5 mg BID (45 mg) vs. placebo was significant.|ANCOVA|||The ANCOVA model included a term for treatment, as well as covariates for baseline mMS, and age at entry to the study.||1.32|-1.35|0.982
72573910|NCT03923530|144674466|SUPERIORITY|||||||0.12|||||||t-test, 2 sided|||Change from baseline to 8 weeks||||0.12
72573911|NCT03923530|144674467|SUPERIORITY|||||||0.49|||||||t-test, 2 sided|||Change from baseline to 8 weeks||||0.49
72573912|NCT03923530|144674468|SUPERIORITY|||||||0.03|||||||t-test, 2 sided|||Change from baseline to 8 weeks||||0.03
72573913|NCT03923530|144674469|SUPERIORITY|||||||0.27|||||||t-test, 2 sided|||Change from baseline to 8 weeks||||0.27
72537926|NCT03692078|144605790|EQUIVALENCE|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 2 is equal to Group 1 on Day 7. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 2 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-0.467|||<|0.0001|TWO_SIDED|95.0|-0.677|-0.256|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 2 is equal to Group 1 on Day 7. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 2 is NOT equal to Group 1 on Day 7. (mITT Population)||-0.256|-0.677|<.0001
72573914|NCT03923530|144674470|SUPERIORITY|||||||0.18|||||||t-test, 2 sided|||Change from baseline to 8 weeks||||0.18
72573915|NCT03923530|144674471|SUPERIORITY|||||||0.8|||||||t-test, 2 sided|||Change from baseline to 8 weeks||||0.8
72573916|NCT03923530|144674472|SUPERIORITY|||||||0.76|||||||t-test, 2 sided|||Change from baseline to 8 weeks||||0.76
72573917|NCT01158573|144674507|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Hypothesis that leptin levels in OA is not different from the other 3 groups.|ANOVA|||||||<0.0001
72573918|NCT01158573|144674508|SUPERIORITY_OR_OTHER|||||||0.002|||||||ANOVA|||||||0.002
72573919|NCT01158573|144674509|SUPERIORITY_OR_OTHER|||||||0.725|||||||ANOVA|||||||0.725
72573920|NCT01158573|144674510|SUPERIORITY_OR_OTHER|||||||0.16|||||||ANOVA|||||||0.16
72627038|NCT01405196|144783276|SUPERIORITY||LS mean difference|-5.41|||||TWO_SIDED|90.0|-12.3|1.49||||||Week 2: Analysis was done using linear mixed effect model that included fixed factors of the stratification factors, treatment, visit, treatment by visit and baseline VAS.||1.49|-12.30|
72573921|NCT00073021|144674522|SUPERIORITY_OR_OTHER||Difference in Success Rates|12.543||||0.0357|TWO_SIDED|95.0|0.96|24.12|||Chi-squared|||It was assumed that true rate of improvement for 2.4 g/day treatment group is 40% and for the 4.8 g/day group is 60%. To detect a true difference of 20% between these 2 groups with 2-sided test, type I error of 0.05 (alpha = 0.05), and power of 80%, 120 patients with moderately active ulcerative colitis were required per group to complete the study.||24.12|0.96|0.0357
72573922|NCT00073021|144674523|SUPERIORITY_OR_OTHER||Difference Between Means|-0.5||||0.1594|TWO_SIDED|95.0|-1.28|0.21|||ANOVA|||||0.21|-1.28|0.1594
72573923|NCT00073021|144674523|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Compared to baseline|t-test, 2 sided|The 2-sample t-test will be used to examine the treatment effect.||||||<0.0001
72573924|NCT00073021|144674523|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Compared to baseline|t-test, 2 sided|Teh 2-sample t-test will be used to examine the treatment effect.||||||<0.0001
72573925|NCT00073021|144674524|SUPERIORITY_OR_OTHER||Difference in Success Rates|3.75||||0.5774|TWO_SIDED|95.0|-9.43|16.93|||Chi-squared|||||16.93|-9.43|0.5774
72573926|NCT00073021|144674525|SUPERIORITY_OR_OTHER||Difference in Success Rates|6.19||||0.2991|TWO_SIDED|95.0|-5.47|17.86|||Chi-squared|||||17.86|-5.47|0.2991
72573927|NCT00073021|144674526|SUPERIORITY_OR_OTHER||Difference in Success Rates|2.74||||0.6543|TWO_SIDED|95.0|-9.25|14.73|||Chi-squared|||||14.73|-9.25|0.6543
72573928|NCT00073021|144674527|SUPERIORITY_OR_OTHER||Difference in Success Rates|1.05||||0.8542|TWO_SIDED|95.0|-10.19|12.29|||Chi-squared|||||12.29|-10.19|0.8542
72573929|NCT00073021|144674528|SUPERIORITY_OR_OTHER||Difference in Success Rates|-0.96||||0.8859|TWO_SIDED|95.0|-14.09|12.17|||Chi-squared|||||12.17|-14.09|0.8859
72573930|NCT00073021|144674529|SUPERIORITY_OR_OTHER||Difference in Success Rates|9.73||||0.0758|TWO_SIDED|95.0|-0.94|20.4|||Chi-squared|||||20.40|-0.94|0.0758
72573931|NCT00073021|144674530|SUPERIORITY_OR_OTHER|||||||0.8308||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.8308
72573932|NCT00073021|144674530|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|95.0||||Compared to baseline|t-test, 2 sided|||||||<0.0001
72573933|NCT00073021|144674530|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Compared to baseline.|t-test, 2 sided|||||||<0.0001
72573934|NCT00073021|144674531|SUPERIORITY_OR_OTHER|||||||0.534||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.5340
72573935|NCT00073021|144674531|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Compared to baseline|t-test, 2 sided|||||||<0.0001
72573936|NCT00073021|144674531|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Compared to baseline|t-test, 2 sided|||||||<0.0001
72573937|NCT00073021|144674532|SUPERIORITY_OR_OTHER||Difference in Success Rates|11.1||||0.0966|TWO_SIDED|95.0|-1.87|24.14|||Chi-squared|||||24.14|-1.87|0.0966
72573938|NCT00073021|144674533|SUPERIORITY_OR_OTHER||Difference in Success Rates|9.75||||0.1173|TWO_SIDED|95.0|-2.39|21.89|||Chi-squared|||||21.89|-2.39|0.1173
72573939|NCT03316378|144674574|SUPERIORITY||Mean Difference (Final Values)|73.8||||0.44|TWO_SIDED|||||Adjusted for multiple comparisons|ANOVA|||Specific Aim 1: Between groups||||0.44
72573940|NCT03316378|144674574|SUPERIORITY||Mean Difference (Final Values)|31.7||||0.08|TWO_SIDED|||||P-value adjusted for multiple comparisons|ANOVA|||Specific Aim 2: Effect of time||||0.08
72573941|NCT03316378|144674575|SUPERIORITY||Mean Difference (Final Values)|6.9|||<|0.001|TWO_SIDED|||||P-value adjusted for multiple comparisons|ANOVA|||Specific Aim 1: Between groups||||<0.001
72573942|NCT03316378|144674575|SUPERIORITY||Mean Difference (Final Values)|1.6||||0.012|TWO_SIDED|||||P-value adjusted for multiple comparisons|ANOVA|||Specific Aim 2: Effect of time||||0.012
72573943|NCT03316378|144674576|SUPERIORITY||Mean Difference (Final Values)|0.15||||1|TWO_SIDED|||||P-value adjusted for multiple comparisons|ANOVA|||Specific Aim 1: Between groups||||1.0
72573944|NCT03316378|144674576|SUPERIORITY||Mean Difference (Final Values)|0.05||||1|TWO_SIDED|||||P-value adjusted for multiple comparisons|ANOVA|||Specific Aim 2: Effect of time||||1.0
72573945|NCT01672970|144674593|SUPERIORITY_OR_OTHER|||||||0|TWO_SIDED||||||Wilcoxon Signed Rank Test|||Statistical analysis at Month 3||||0.000
72573946|NCT01672970|144674593|SUPERIORITY_OR_OTHER|||||||0|TWO_SIDED||||||Wilcoxon Signed Rank Test|||Statistical Analysis at Month 6||||0.000
72573947|NCT01672970|144674594|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED||||||Wilcoxon Signed Rank Test|||Statistical Analysis at Month 3||||0.001
72627039|NCT01405196|144783276|SUPERIORITY||LS Mean difference|-1.39|||||TWO_SIDED|90.0|-8.21|5.42||||||Week 4: Analysis was done using linear mixed effect model that included fixed factors of the stratification factors, treatment, visit, treatment by visit and baseline VAS.||5.42|-8.21|
72537927|NCT03692078|144605790|EQUIVALENCE|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 3 is equal to Group 1 on Day 5. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 3 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-0.311||||0.0052|TWO_SIDED|95.0|-0.556|-0.066|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 3 is equal to Group 1 on Day 5. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 3 is NOT equal to Group 1 on Day 5. (mITT Population)||-0.066|-0.556|0.0052
72537928|NCT03692078|144605790|EQUIVALENCE|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 3 is equal to Group 1 on Day 7. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 3 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-0.391|||<|0.0001|TWO_SIDED|95.0|-0.6|-0.182|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 3 is equal to Group 1 on Day 7. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 3 is NOT equal to Group 1 on Day 7. (mITT Population)||-0.182|-0.600|<.0001
72537929|NCT03692078|144605790|EQUIVALENCE|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 4 is equal to Group 1 on Day 5. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 4 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-1.793|||<|0.0001|TWO_SIDED|95.0|-2.07|-1.516|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 4 is equal to Group 1 on Day 5. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 4 is NOT equal to Group 1 on Day 5. (mITT Population)||-1.516|-2.070|<.0001
72537930|NCT03692078|144605790|EQUIVALENCE|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 4 is equal to Group 1 on Day 7. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 4 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-1.859|||<|0.0001|TWO_SIDED|95.0|-2.098|-1.621|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 4 is equal to Group 1 on Day 7. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 4 is NOT equal to Group 1 on Day 7. (mITT Population)||-1.621|-2.098|<.0001
72537931|NCT03692078|144605790|EQUIVALENCE|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 5 is equal to Group 1 on Day 5. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 5 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-1.809|||<|0.0001|TWO_SIDED|95.0|-2.082|-1.535|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 5 is equal to Group 1 on Day 5. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 5 is NOT equal to Group 1 on Day 5. (mITT Population)||-1.535|-2.082|<.0001
72537932|NCT03692078|144605790|EQUIVALENCE|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 5 is equal to Group 1 on Day 7. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 5 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-1.858|||<|0.0001|TWO_SIDED|95.0|-2.096|-1.621|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 5 is equal to Group 1 on Day 7. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 5 is NOT equal to Group 1 on Day 7. (mITT Population)||-1.621|-2.096|<.0001
72537933|NCT03692078|144605790|EQUIVALENCE|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 2 is equal to Group 6 on Day 5. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 2 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|1.427|||<|0.0001|TWO_SIDED|95.0|1.166|1.688|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 2 is equal to Group 6 on Day 5. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 2 is NOT equal to Group 6 on Day 5. (mITT Population)||1.688|1.166|<.0001
72537934|NCT03692078|144605790|EQUIVALENCE|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 2 is equal to Group 6 on Day 7. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 2 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|1.393|||<|0.0001|TWO_SIDED|95.0|1.166|1.62|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 2 is equal to Group 6 on Day 7. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 2 is NOT equal to Group 6 on Day 7. (mITT Population)||1.620|1.166|<.0001
72573948|NCT01672970|144674594|SUPERIORITY_OR_OTHER|||||||0.005|TWO_SIDED||||||Wilcoxon Signed Rank Test|||Statistical Analysis at Month 6||||0.005
72573949|NCT01672970|144674595|SUPERIORITY_OR_OTHER|||||||0|TWO_SIDED||||||Wilcoxon Signed Rank Test|||Statistical Analysis at Month 3||||0.000
72573950|NCT01672970|144674595|SUPERIORITY_OR_OTHER|||||||0|TWO_SIDED||||||Wilcoxon Signed Rank Test|||Statistical Analysis at Month 6||||0.000
72573951|NCT01672970|144674596|SUPERIORITY_OR_OTHER|||||||0|TWO_SIDED||||||Wilcoxon Signed Rank Test|||Statistical Analysis at Month 3||||0.000
72573952|NCT01672970|144674596|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED||||||Wilcoxon Signed Rank Test|||||||0.001
72537935|NCT03692078|144605790|EQUIVALENCE|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 3 is equal to Group 6 on Day 5. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 3 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|1.541|||<|0.0001|TWO_SIDED|95.0|1.278|1.803|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 3 is equal to Group 6 on Day 5. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 3 is NOT equal to Group 6 on Day 5. (mITT Population)||1.803|1.278|<.0001
72537936|NCT03692078|144605790|EQUIVALENCE|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 3 is equal to Group 6 on Day 7. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 3 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|1.469|||<|0.0001|TWO_SIDED|95.0|1.243|1.695|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 3 is equal to Group 6 on Day 7. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 3 is NOT equal to Group 6 on Day 7. (mITT Population)||1.695|1.243|<.0001
72537937|NCT03692078|144605790|EQUIVALENCE|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 4 is equal to Group 6 on Day 5. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 4 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|0.059||||0.9987|TWO_SIDED|95.0|-0.233|0.351|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 4 is equal to Group 6 on Day 5. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 4 is NOT equal to Group 6 on Day 5. (mITT Population)||0.351|-0.233|0.9987
72537938|NCT03692078|144605790|EQUIVALENCE|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 4 is equal to Group 6 on Day 7. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 4 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|0.0||||1|TWO_SIDED|95.0|-0.253|0.254|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 4 is equal to Group 6 on Day 7. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 4 is NOT equal to Group 6 on Day 7. (mITT Population)||0.254|-0.253|1.0000
72537939|NCT03692078|144605790|EQUIVALENCE|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 5 is equal to Group 6 on Day 5. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 5 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|0.043||||0.9999|TWO_SIDED|95.0|-0.246|0.332|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 5 is equal to Group 6 on Day 5. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 5 is NOT equal to Group 6 on Day 5. (mITT Population)||0.332|-0.246|0.9999
72537940|NCT03692078|144605790|EQUIVALENCE|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 5 is equal to Group 6 on Day 7. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 5 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|0.002||||1|TWO_SIDED|95.0|-0.251|0.254|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 5 is equal to Group 6 on Day 7. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 5 is NOT equal to Group 6 on Day 7. (mITT Population)||0.254|-0.251|1.0000
72573953|NCT01672970|144674599|SUPERIORITY_OR_OTHER|||||||0|TWO_SIDED||||||Wilcoxon Signed Ranks Test|||Statistical Analysis at Month 3||||0.000
72573954|NCT01672970|144674599|SUPERIORITY_OR_OTHER|||||||0|TWO_SIDED||||||Wilcoxon Signed Ranks Test|||Statistical Analysis at Month 6||||0.000
72573955|NCT01672970|144674600|SUPERIORITY_OR_OTHER|||||||0|TWO_SIDED||||||Wilcoxon Signed Ranks Test|||Statistical Analysis at Month 3||||0.000
72573956|NCT01672970|144674600|SUPERIORITY_OR_OTHER|||||||0|TWO_SIDED||||||Wilcoxon Signed Ranks Test|||Statistical Analysis at Month 6||||0.000
72573957|NCT01672970|144674605|SUPERIORITY_OR_OTHER|||||||0|TWO_SIDED||||||Wilcoxon Signed Ranks Test|||Statistical Analysis at Month 3||||0.000
72573958|NCT01672970|144674605|SUPERIORITY_OR_OTHER|||||||0|TWO_SIDED||||||Wilcoxon Signed Ranks Test|||Statistical Analysis at Month 6||||0.000
72573959|NCT01672970|144674606|SUPERIORITY_OR_OTHER|||||||0|TWO_SIDED||||||Wilcoxon Signed Ranks Test|||Statistical Analysis at Month 3||||0.000
72573960|NCT01672970|144674606|SUPERIORITY_OR_OTHER|||||||0|TWO_SIDED||||||Wilcoxon Signed Ranks Test|||Statistical Analysis at Month 6||||0.000
72573961|NCT01672970|144674607|SUPERIORITY_OR_OTHER|||||||0|TWO_SIDED||||||Wilcoxon Signed Ranks Test|||Statistical Analysis at Month 3||||0.000
72573962|NCT01672970|144674607|SUPERIORITY_OR_OTHER|||||||0|TWO_SIDED||||||Wilcoxon Signed Ranks Test|||Statistical Analysis at Month 6||||0.000
72573963|NCT01672970|144674608|SUPERIORITY_OR_OTHER|||||||0|TWO_SIDED||||||Wilcoxon Signed Rank Test|||Statistical Analysis at Month 3||||0.000
72573964|NCT01672970|144674608|SUPERIORITY_OR_OTHER|||||||0|TWO_SIDED||||||Wilcoxon Signed Rank Test|||Statistical Analysis at Month 6||||0.000
72573965|NCT01672970|144674609|SUPERIORITY_OR_OTHER|||||||0|TWO_SIDED||||||Wilcoxon Signed Rank Test|||Statistical Analysis at Month 3||||0.000
72573966|NCT01672970|144674609|SUPERIORITY_OR_OTHER|||||||0|TWO_SIDED||||||Wilcoxon Signed Rank Test|||Statistical Analysis at Month 6||||0.000
72573967|NCT01672970|144674610|SUPERIORITY_OR_OTHER|||||||0|TWO_SIDED||||||Wilcoxon Signed Rank Test|||Statistical Analysis at Month 3||||0.000
72627040|NCT01405196|144783276|SUPERIORITY||LS Mean difference|1.3|||||TWO_SIDED|90.0|-5.71|8.32||||||Week 6: Analysis was done using linear mixed effect model that included fixed factors of the stratification factors, treatment, visit, treatment by visit and baseline VAS.||8.32|-5.71|
72627041|NCT01405196|144783276|SUPERIORITY||LS Mean difference|4.67|||||TWO_SIDED|90.0|-2.22|11.57||||||Week 8: Analysis was done using linear mixed effect model that included fixed factors of the stratification factors, treatment, visit, treatment by visit and baseline VAS.||11.57|-2.22|
72627042|NCT01405196|144783276|SUPERIORITY||LS Mean difference|-3.98|||||TWO_SIDED|90.0|-11.04|3.07||||||Week 12: Analysis was done using linear mixed effect model that included fixed factors of the stratification factors, treatment, visit, treatment by visit and baseline VAS.||3.07|-11.04|
72627043|NCT01405196|144783276|SUPERIORITY||LS Mean difference|-2.89|||||TWO_SIDED|90.0|-9.87|4.1||||||Week 16: Analysis was done using linear mixed effect model that included fixed factors of the stratification factors, treatment, visit, treatment by visit and baseline VAS.||4.10|-9.87|
72537941|NCT03692078|144605792|EQUIVALENCE|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 5. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|2.407|||<|0.0001|TWO_SIDED|95.0|2.283|2.531|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 5. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 5. (mITT Population)||2.531|2.283|<.0001
72627044|NCT01405196|144783276|SUPERIORITY||LS Mean difference|-6.21|||||TWO_SIDED|90.0|-13.37|0.94||||||Week 20: Analysis was done using linear mixed effect model that included fixed factors of the stratification factors, treatment, visit, treatment by visit and baseline VAS.||0.94|-13.37|
72627045|NCT01405196|144783276|SUPERIORITY||LS Mean difference|1.98|||||TWO_SIDED|90.0|-5.17|9.13||||||Week 24: Analysis was done using linear mixed effect model that included fixed factors of the stratification factors, treatment, visit, treatment by visit and baseline VAS.||9.13|-5.17|
72537942|NCT03692078|144605792|EQUIVALENCE|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 7. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|2.398|||<|0.0001|TWO_SIDED|95.0|2.253|2.543|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 7. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 7. (mITT Population)||2.543|2.253|<.0001
72537943|NCT03692078|144605792|EQUIVALENCE|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 5. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|2.303|||<|0.0001|TWO_SIDED|95.0|2.187|2.42|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 5. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 5. (mITT Population)||2.420|2.187|<.0001
72537944|NCT03692078|144605792|EQUIVALENCE|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 7. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|2.25|||<|0.0001|TWO_SIDED|95.0|2.112|2.389|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 7. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 7. (mITT Population)||2.389|2.112|<.0001
72573968|NCT01672970|144674610|SUPERIORITY_OR_OTHER|||||||0|TWO_SIDED||||||Wilcoxon Signed Rank Test|||Statistical Analysis at Month 6||||0.000
72573969|NCT01193127|144674655|SUPERIORITY_OR_OTHER||least-squares mean difference|0.9|STANDARD_ERROR_OF_MEAN|0.1||0||95.0|0.6|1.1||Repeated measures model includes treatment (OMS302, ketorolac tromethamine, and vehicle), time-point and LOCS II grade as covariates|repeated measures model|All data time points collected used in the analysis.|OMS302 - Vehicle (BSS)|||1.1|0.6|0.0000
72573970|NCT01193127|144674655|SUPERIORITY_OR_OTHER||least-squares mean difference|0.7|STANDARD_ERROR_OF_MEAN|0.1||0||95.0|0.5|0.9||Repeated measures model includes treatment (OMS302, ketorolac tromethamine, and vehicle), time-point and LOCS II grade as covariates.|repeated measures model|OMS302 - ketorolac tromethamine||||0.9|0.5|0.0000
72573971|NCT01193127|144674656|SUPERIORITY_OR_OTHER||least-squares mean difference|-4.6|STANDARD_ERROR_OF_MEAN|2.2||0.0421||95.0|-8.9|-0.2||Repeated measures model includes treatment (OMS302, PE and vehicle), time point and LOCS II grade as covariates|repeated measures model||OMS302 - Vehicle (BSS)|||-0.2|-8.9|0.0421
72573972|NCT01193127|144674656|SUPERIORITY_OR_OTHER||least-squares mean difference|-5.9|STANDARD_ERROR_OF_MEAN|2.2||0.0093||95.0|-10.3|-1.5||Repeated measures model includes treatment (OMS302, PE and vehicle), time point and LOCS II grade as covariates.|repeated measures model||OMS302 - PE|||-1.5|-10.3|0.0093
72627046|NCT01405196|144783276|SUPERIORITY||LS Mean difference|2.07|||||TWO_SIDED|90.0|-4.7|8.84||||||Week 2: Analysis was done using linear mixed effect model that included fixed factors of the stratification factors, treatment, visit, treatment by visit and baseline VAS.||8.84|-4.70|
72627047|NCT01405196|144783276|SUPERIORITY||LS Mean difference|-2.81|||||TWO_SIDED|90.0|-9.62|4.0||||||Week 4: Analysis was done using linear mixed effect model that included fixed factors of the stratification factors, treatment, visit, treatment by visit and baseline VAS.||4.00|-9.62|
72627048|NCT01405196|144783276|SUPERIORITY||LS Mean difference|3.97|||||TWO_SIDED|90.0|-2.95|10.9||||||Week 6: Analysis was done using linear mixed effect model that included fixed factors of the stratification factors, treatment, visit, treatment by visit and baseline VAS.||10.90|-2.95|
72537945|NCT03692078|144605792|EQUIVALENCE|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 5. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|2.285|||<|0.0001|TWO_SIDED|95.0|2.166|2.404|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 5. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 5. (mITT Population)||2.404|2.166|<.0001
72537946|NCT03692078|144605792|EQUIVALENCE|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 7. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|2.272|||<|0.0001|TWO_SIDED|95.0|2.133|2.412|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 7. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 7. (mITT Population)||2.412|2.133|<.0001
72537947|NCT03692078|144605792|EQUIVALENCE|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 5. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|1.992|||<|0.0001|TWO_SIDED|95.0|1.844|2.14|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 5. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 5. (mITT Population)||2.140|1.844|<.0001
72537948|NCT03692078|144605792|EQUIVALENCE|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 7. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|1.894|||<|0.0001|TWO_SIDED|95.0|1.719|2.069|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 7. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 7. (mITT Population)||2.069|1.719|<.0001
72537949|NCT03692078|144605792|EQUIVALENCE|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 5. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|2.102|||<|0.0001|TWO_SIDED|95.0|1.955|2.248|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 5. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 5. (mITT Population)||2.248|1.955|<.0001
72537950|NCT03692078|144605792|EQUIVALENCE|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 7. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|2.075|||<|0.0001|TWO_SIDED|95.0|1.9|2.25|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 7. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 7. (mITT Population)||2.250|1.900|<.0001
72573973|NCT01193127|144674657|SUPERIORITY_OR_OTHER|||||||0.63||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel-Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.630
72573974|NCT01193127|144674657|SUPERIORITY_OR_OTHER|||||||0.769||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel-Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.769
72573975|NCT01193127|144674657|SUPERIORITY_OR_OTHER|||||||0.025||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel-Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.025
72573976|NCT01193127|144674658|SUPERIORITY_OR_OTHER|||||||0.229||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel-Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.229
72573977|NCT01193127|144674658|SUPERIORITY_OR_OTHER|||||||0.162||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel-Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.162
72573978|NCT01193127|144674658|SUPERIORITY_OR_OTHER|||||||0.226||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel-Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.226
72573979|NCT01193127|144674659|SUPERIORITY_OR_OTHER|||||||0.177||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel-Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.177
72573980|NCT01193127|144674659|SUPERIORITY_OR_OTHER|||||||0.051||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel-Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.051
72573981|NCT01193127|144674659|SUPERIORITY_OR_OTHER|||||||0.497||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel-Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.497
72573982|NCT01193127|144674660|SUPERIORITY_OR_OTHER|||||||0.48||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel-Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.480
72627049|NCT01405196|144783276|SUPERIORITY||LS Mean difference|2.56|||||TWO_SIDED|90.0|-4.29|9.4||||||Week 8: Analysis was done using linear mixed effect model that included fixed factors of the stratification factors, treatment, visit, treatment by visit and baseline VAS.||9.40|-4.29|
72537951|NCT03692078|144605792|EQUIVALENCE|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 5. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|1.89|||<|0.0001|TWO_SIDED|95.0|1.746|2.033|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 5. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 5. (mITT Population)||2.033|1.746|<.0001
72537952|NCT03692078|144605792|EQUIVALENCE|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 7. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|1.944|||<|0.0001|TWO_SIDED|95.0|1.775|2.114|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 7. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 7. (mITT Population)||2.114|1.775|<.0001
72537953|NCT03692078|144605792|EQUIVALENCE|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 5. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-0.104||||0.8674|TWO_SIDED|95.0|-0.345|0.137|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 5. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 5. (mITT Population)||0.137|-0.345|0.8674
72537954|NCT03692078|144605792|EQUIVALENCE|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 7. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-0.148||||0.6519|TWO_SIDED|95.0|-0.429|0.133|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 7. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 7. (mITT Population)||0.133|-0.429|0.6519
72537955|NCT03692078|144605792|EQUIVALENCE|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 5. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-0.122||||0.7301|TWO_SIDED|95.0|-0.363|0.119|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 5. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 5. (mITT Population)||0.119|-0.363|0.7301
72537956|NCT03692078|144605792|EQUIVALENCE|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 7. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-0.126||||0.8076|TWO_SIDED|95.0|-0.405|0.154|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 7. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 7. (mITT Population)||0.154|-0.405|0.8076
72537957|NCT03692078|144605792|EQUIVALENCE|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 5. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-0.415||||0.0004|TWO_SIDED|95.0|-0.689|-0.142|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 5. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 5. (mITT Population)||-0.142|-0.689|0.0004
72573983|NCT01193127|144674660|SUPERIORITY_OR_OTHER|||||||0.09||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel-Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.090
72573984|NCT01193127|144674660|SUPERIORITY_OR_OTHER|||||||0.439||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel-Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.439
72573985|NCT01193127|144674661|SUPERIORITY_OR_OTHER|||||||0.812||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel-Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.812
72573986|NCT01193127|144674661|SUPERIORITY_OR_OTHER|||||||0.48||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel-Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.480
72627050|NCT01405196|144783276|SUPERIORITY||LS Mean difference|3.14|||||TWO_SIDED|90.0|-3.67|9.94||||||Week 12: Analysis was done using linear mixed effect model that included fixed factors of the stratification factors, treatment, visit, treatment by visit and baseline VAS.||9.94|-3.67|
72627051|NCT01405196|144783276|SUPERIORITY||LS Mean difference|-4.94|||||TWO_SIDED|90.0|-11.91|2.03||||||Week 16: Analysis was done using linear mixed effect model that included fixed factors of the stratification factors, treatment, visit, treatment by visit and baseline VAS.||2.03|-11.91|
72627052|NCT01405196|144783276|SUPERIORITY||LS Mean difference|-2.64|||||TWO_SIDED|90.0|-9.61|4.32||||||Week 20: Analysis was done using linear mixed effect model that included fixed factors of the stratification factors, treatment, visit, treatment by visit and baseline VAS.||4.32|-9.61|
72537958|NCT03692078|144605792|EQUIVALENCE|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 7. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-0.504||||0.0002|TWO_SIDED|95.0|-0.822|-0.185|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 7. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 7. (mITT Population)||-0.185|-0.822|0.0002
72537959|NCT03692078|144605792|EQUIVALENCE|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 5. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-0.306||||0.0183|TWO_SIDED|95.0|-0.578|-0.034|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 5. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 5. (mITT Population)||-0.034|-0.578|0.0183
72537960|NCT03692078|144605792|EQUIVALENCE|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 7. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-0.323||||0.0443|TWO_SIDED|95.0|-0.641|-0.005|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 7. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 7. (mITT Population)||-0.005|-0.641|0.0443
72537961|NCT03692078|144605792|EQUIVALENCE|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 5. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|0.414||||0.0002|TWO_SIDED|95.0|0.155|0.672|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 5. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 5. (mITT Population)||0.672|0.155|0.0002
72537962|NCT03692078|144605792|EQUIVALENCE|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 7. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|0.306||||0.0454|TWO_SIDED|95.0|0.004|0.608|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 7. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 7. (mITT Population)||0.608|0.004|0.0454
72537963|NCT03692078|144605792|EQUIVALENCE|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 5. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|0.396||||0.0004|TWO_SIDED|95.0|0.136|0.655|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 5. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 5. (mITT Population)||0.655|0.136|0.0004
72573987|NCT01193127|144674661|SUPERIORITY_OR_OTHER|||||||0.16||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel-Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.160
72573988|NCT01193127|144674662|SUPERIORITY_OR_OTHER|||||||0.085||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel-Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.085
72573989|NCT01193127|144674662|SUPERIORITY_OR_OTHER|||||||0.742||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel-Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.742
72573990|NCT01193127|144674662|SUPERIORITY_OR_OTHER|||||||0.021||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel-Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.021
72627053|NCT01405196|144783276|SUPERIORITY||LS Mean difference|2.66|||||TWO_SIDED|90.0|-4.48|9.8||||||Week 24: Analysis was done using linear mixed effect model that included fixed factors of the stratification factors, treatment, visit, treatment by visit and baseline VAS.||9.80|-4.48|
72573991|NCT01193127|144674663|SUPERIORITY_OR_OTHER|||||||0.081||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel-Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.081
72627054|NCT01405196|144783277|SUPERIORITY||LS mean difference|3.63||||||90.0|-2.56|9.83||||||Week 4: Analysis was done using linear mixed effect model that included fixed factors of the stratification factors, treatment, visit, treatment by visit and baseline tender score.||9.83|-2.56|
72627055|NCT01405196|144783277|SUPERIORITY||LS mean difference|-2.02||||||90.0|-8.21|4.18||||||Week 8: Analysis was done using linear mixed effect model that included fixed factors of the stratification factors, treatment, visit, treatment by visit and baseline tender score.||4.18|-8.21|
72573992|NCT01193127|144674663|SUPERIORITY_OR_OTHER|||||||0.202||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel-Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.202
72627056|NCT01405196|144783277|SUPERIORITY||LS mean difference|2.62|||||TWO_SIDED|90.0|-3.57|8.82||||||Week 12: Analysis was done using linear mixed effect model that included fixed factors of the stratification factors, treatment, visit, treatment by visit and baseline tender score.||8.82|-3.57|
72537964|NCT03692078|144605792|EQUIVALENCE|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 7. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|0.328||||0.0261|TWO_SIDED|95.0|0.026|0.63|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 7. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 7. (mITT Population)||0.630|0.026|0.0261
72537965|NCT03692078|144605792|EQUIVALENCE|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 5. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|0.102||||0.9455|TWO_SIDED|95.0|-0.187|0.392|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 5. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 5. (mITT Population)||0.392|-0.187|0.9455
72537966|NCT03692078|144605792|EQUIVALENCE|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 7. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|-0.05||||0.9999|TWO_SIDED|95.0|-0.387|0.287|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 7. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 7. (mITT Population)||0.287|-0.387|0.9999
72537967|NCT03692078|144605792|EQUIVALENCE|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 5. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|0.212||||0.2633|TWO_SIDED|95.0|-0.074|0.498|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 5. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 5. (mITT Population)||0.498|-0.074|0.2633
72537968|NCT03692078|144605792|EQUIVALENCE|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 7. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|0.13||||0.8769|TWO_SIDED|95.0|-0.205|0.465|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 7. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 7. (mITT Population)||0.465|-0.205|0.8769
72573993|NCT01193127|144674663|SUPERIORITY_OR_OTHER|||||||0.606||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel-Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.606
72573994|NCT01193127|144674664|SUPERIORITY_OR_OTHER|||||||0.893||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.893
72573995|NCT01193127|144674664|SUPERIORITY_OR_OTHER|||||||0.553||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.553
72573996|NCT01193127|144674664|SUPERIORITY_OR_OTHER|||||||0.412||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.412
72573997|NCT01193127|144674665|SUPERIORITY_OR_OTHER|||||||0.186||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.186
72573998|NCT01193127|144674665|SUPERIORITY_OR_OTHER|||||||0.191||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.191
72573999|NCT01193127|144674665|SUPERIORITY_OR_OTHER|||||||0.167||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.167
72627057|NCT01405196|144783277|SUPERIORITY||LS mean difference|1.69|||||TWO_SIDED|90.0|-4.51|7.88||||||Week 16: Analysis was done using linear mixed effect model that included fixed factors of the stratification factors, treatment, visit, treatment by visit and baseline tender score.||7.88|-4.51|
72537969|NCT03692078|144605794|EQUIVALENCE|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 5. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 5. (PP Population)|Mean Difference (Net)|5.417|||<|0.0001|TWO_SIDED|95.0|5.315|5.52|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 5. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 5. (PP Population)||5.520|5.315|<.0001
72537970|NCT03692078|144605794|EQUIVALENCE|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 7. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 7. (PP Population)|Mean Difference (Net)|5.436|||<|0.0001|TWO_SIDED|95.0|5.324|5.548|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 7. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 7. (PP Population)||5.548|5.324|<.0001
72537971|NCT03692078|144605794|EQUIVALENCE|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 5. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 5. (PP Population)|Mean Difference (Net)|4.957|||<|0.0001|TWO_SIDED|95.0|4.86|5.053|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 5. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 5. (PP Population)||5.053|4.860|<.0001
72537972|NCT03692078|144605794|EQUIVALENCE|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 7. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 7. (PP Population)|Mean Difference (Net)|4.974|||<|0.0001|TWO_SIDED|95.0|4.867|5.081|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 7. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 7. (PP Population)||5.081|4.867|<.0001
72574000|NCT01193127|144674666|SUPERIORITY_OR_OTHER|||||||0.663||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.663
72574001|NCT01193127|144674666|SUPERIORITY_OR_OTHER|||||||0.326||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.326
72574002|NCT01193127|144674666|SUPERIORITY_OR_OTHER|||||||0.045||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.045
72409229|NCT01706250|144326876|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.1|STANDARD_DEVIATION|0.45||1|||||||Signed Rank|||Change, in Erythema for MAXCLARITY II Vs PROACTIV: from BL to Wk 1 (within group)||||1.0000
72574003|NCT01193127|144674667|SUPERIORITY_OR_OTHER|||||||0.106||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.106
72574004|NCT01193127|144674667|SUPERIORITY_OR_OTHER|||||||0.519||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.519
72574005|NCT01193127|144674667|SUPERIORITY_OR_OTHER|||||||0.039||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.039
72574006|NCT01193127|144674668|SUPERIORITY_OR_OTHER|||||||0.1||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.100
72574007|NCT01193127|144674668|SUPERIORITY_OR_OTHER|||||||0.029||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.029
72574008|NCT01193127|144674668|SUPERIORITY_OR_OTHER|||||||0.525||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.525
72574009|NCT01193127|144674669|SUPERIORITY_OR_OTHER|||||||0.642||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.642
72574010|NCT01193127|144674669|SUPERIORITY_OR_OTHER|||||||0.442||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.442
72574011|NCT01193127|144674669|SUPERIORITY_OR_OTHER|||||||0.467||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.467
72574012|NCT01193127|144674670|SUPERIORITY_OR_OTHER|||||||0.695||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.695
72574013|NCT01193127|144674670|SUPERIORITY_OR_OTHER|||||||0.355||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.355
72537973|NCT03692078|144605794|EQUIVALENCE|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 5. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 5. (PP Population)|Mean Difference (Net)|4.984|||<|0.0001|TWO_SIDED|95.0|4.886|5.082|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 5. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 5. (PP Population)||5.082|4.886|<.0001
72537974|NCT03692078|144605794|EQUIVALENCE|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 7. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 7. (PP Population)|Mean Difference (Net)|4.975|||<|0.0001|TWO_SIDED|95.0|4.868|5.082|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 7. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 7. (PP Population)||5.082|4.868|<.0001
72537975|NCT03692078|144605794|EQUIVALENCE|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 5. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 5. (PP Population)|Mean Difference (Net)|3.49|||<|0.0001|TWO_SIDED|95.0|3.367|3.612|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 5. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 5. (PP Population)||3.612|3.367|<.0001
72537976|NCT03692078|144605794|EQUIVALENCE|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 7. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 7. (PP Population)|Mean Difference (Net)|3.347|||<|0.0001|TWO_SIDED|95.0|3.212|3.483|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 7. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 7. (PP Population)||3.483|3.212|<.0001
72537977|NCT03692078|144605794|EQUIVALENCE|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 5. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 5. (PP Population)|Mean Difference (Net)|3.539|||<|0.0001|TWO_SIDED|95.0|3.418|3.66|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 5. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 5. (PP Population)||3.660|3.418|<.0001
72537978|NCT03692078|144605794|EQUIVALENCE|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 7. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 7. (PP Population)|Mean Difference (Net)|3.419|||<|0.0001|TWO_SIDED|95.0|3.284|3.554|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 7. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 7. (PP Population)||3.554|3.284|<.0001
72537979|NCT03692078|144605794|EQUIVALENCE|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 5. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 5. (PP Population)|Mean Difference (Net)|3.492|||<|0.0001|TWO_SIDED|95.0|3.373|3.611|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 5. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 5. (PP Population)||3.611|3.373|<.0001
72537980|NCT03692078|144605794|EQUIVALENCE|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 7. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 7. (PP Population)|Mean Difference (Net)|3.437|||<|0.0001|TWO_SIDED|95.0|3.306|3.568|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 7. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 7. (PP Population)||3.568|3.306|<.0001
72574014|NCT01193127|144674670|SUPERIORITY_OR_OTHER|||||||0.369||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.369
72574015|NCT01193127|144674671|SUPERIORITY_OR_OTHER|||||||0.124||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.124
72574016|NCT01193127|144674671|SUPERIORITY_OR_OTHER|||||||0.298||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.298
72627058|NCT01405196|144783277|SUPERIORITY||LS mean difference|4.59|||||TWO_SIDED|90.0|-1.61|10.79||||||Week 20: Analysis was done using linear mixed effect model that included fixed factors of the stratification factors, treatment, visit, treatment by visit and baseline tender score.||10.79|-1.61|
72537981|NCT03692078|144605794|EQUIVALENCE|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 5. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 5. (PP Population)|Mean Difference (Net)|-0.461|||<|0.0001|TWO_SIDED|95.0|-0.66|-0.262|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 5. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 5. (PP Population)||-0.262|-0.660|<.0001
72537982|NCT03692078|144605794|EQUIVALENCE|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 7. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 7. (PP Population)|Mean Difference (Net)|-0.462|||<|0.0001|TWO_SIDED|95.0|-0.679|-0.244|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 7. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 7. (PP Population)||-0.244|-0.679|<.0001
72537983|NCT03692078|144605794|EQUIVALENCE|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 5. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 5. (PP Population)|Mean Difference (Net)|-0.433|||<|0.0001|TWO_SIDED|95.0|-0.633|-0.233|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 5. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 5. (PP Population)||-0.233|-0.633|<.0001
72537984|NCT03692078|144605794|EQUIVALENCE|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 7. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 7. (PP Population)|Mean Difference (Net)|-0.461|||<|0.0001|TWO_SIDED|95.0|-0.678|-0.244|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 7. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 7. (PP Population)||-0.244|-0.678|<.0001
72537985|NCT03692078|144605794|EQUIVALENCE|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 5. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 5. (PP Population)|Mean Difference (Net)|-1.928|||<|0.0001|TWO_SIDED|95.0|-2.154|-1.701|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 5. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 5. (PP Population)||-1.701|-2.154|<.0001
72537986|NCT03692078|144605794|EQUIVALENCE|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 7. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 7. (PP Population)|Mean Difference (Net)|-2.089|||<|0.0001|TWO_SIDED|95.0|-2.336|-1.842|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 7. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 7. (PP Population)||-1.842|-2.336|<.0001
72537987|NCT03692078|144605794|EQUIVALENCE|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 5. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 5. (PP Population)|Mean Difference (Net)|-1.879|||<|0.0001|TWO_SIDED|95.0|-2.102|-1.656|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 5. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 5. (PP Population)||-1.656|-2.102|<.0001
72537988|NCT03692078|144605794|EQUIVALENCE|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 7. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 7. (PP Population)|Mean Difference (Net)|-2.017|||<|0.0001|TWO_SIDED|95.0|-2.262|-1.772|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 7. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 7. (PP Population)||-1.772|-2.262|<.0001
72574017|NCT01193127|144674671|SUPERIORITY_OR_OTHER|||||||0.291||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.291
72574018|NCT01193127|144674672|SUPERIORITY_OR_OTHER|||||||0.825||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.825
72627059|NCT01405196|144783277|SUPERIORITY||LS mean difference|3.95||||||90.0|-2.24|10.15||||||Week 24: Analysis was done using linear mixed effect model that included fixed factors of the stratification factors, treatment, visit, treatment by visit and baseline tender score.||10.15|-2.24|
72537989|NCT03692078|144605794|EQUIVALENCE|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 5. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 5. (PP Population)|Mean Difference (Net)|1.465|||<|0.0001|TWO_SIDED|95.0|1.25|1.679|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 5. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 5. (PP Population)||1.679|1.250|<.0001
72537990|NCT03692078|144605794|EQUIVALENCE|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 7. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 7. (PP Population)|Mean Difference (Net)|1.537|||<|0.0001|TWO_SIDED|95.0|1.303|1.772|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 7. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 7. (PP Population)||1.772|1.303|<.0001
72537991|NCT03692078|144605794|EQUIVALENCE|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 5. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 5. (PP Population)|Mean Difference (Net)|1.492|||<|0.0001|TWO_SIDED|95.0|1.277|1.707|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 5. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 5. (PP Population)||1.707|1.277|<.0001
72537992|NCT03692078|144605794|EQUIVALENCE|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 7. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 7. (PP Population)|Mean Difference (Net)|1.538|||<|0.0001|TWO_SIDED|95.0|1.304|1.772|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 7. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 7. (PP Population)||1.772|1.304|<.0001
72537993|NCT03692078|144605794|EQUIVALENCE|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 5. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 5. (PP Population)|Mean Difference (Net)|-0.003||||1|TWO_SIDED|95.0|-0.242|0.237|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 5. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 5. (PP Population)||0.237|-0.242|1.0000
72537994|NCT03692078|144605794|EQUIVALENCE|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 7. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 7. (PP Population)|Mean Difference (Net)|-0.09||||0.9399|TWO_SIDED|95.0|-0.351|0.172|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 7. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 7. (PP Population)||0.172|-0.351|0.9399
72537995|NCT03692078|144605794|EQUIVALENCE|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 5. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 5. (PP Population)|Mean Difference (Net)|0.047||||0.9993|TWO_SIDED|95.0|-0.19|0.283|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 5. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 5. (PP Population)||0.283|-0.190|0.9993
72537996|NCT03692078|144605794|EQUIVALENCE|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 7. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 7. (PP Population)|Mean Difference (Net)|-0.018||||1|TWO_SIDED|95.0|-0.278|0.242|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 7. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 7. (PP Population)||0.242|-0.278|1.0000
72574019|NCT01193127|144674672|SUPERIORITY_OR_OTHER|||||||0.211||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.211
72574020|NCT01193127|144674672|SUPERIORITY_OR_OTHER|||||||0.589||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.589
72574021|NCT01193127|144674673|SUPERIORITY_OR_OTHER|||||||0.401||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.401
72409230|NCT01706250|144326876|SUPERIORITY_OR_OTHER||Signed Rank|0.05|STANDARD_DEVIATION|0.23||1|||||||Signed Rank|||Change, in Erythema for MAXCLARITY II Vs PROACTIV: from BL to Wk 2 (within group)||||1.0000
72409231|NCT01706250|144326877|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.05|STANDARD_DEVIATION|0.22||1|||||||Signed Rank|||Change, in Dryness for MAXCLARITY II Vs PROACTIV: from BL to Wk 1 (within group)||||1.00
72537997|NCT03692078|144605796|EQUIVALENCE|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 5. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|1.805|||<|0.0001|TWO_SIDED|95.0|1.639|1.971|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 5. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 5. (mITT Population)||1.971|1.639|<.0001
72537998|NCT03692078|144605796|EQUIVALENCE|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 7. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|1.788|||<|0.0001|TWO_SIDED|95.0|1.622|1.954|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 7. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 7. (mITT Population)||1.954|1.622|<.0001
72537999|NCT03692078|144605796|EQUIVALENCE|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 5. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|1.29|||<|0.0001|TWO_SIDED|95.0|1.145|1.462|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 5. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 5. (mITT Population)||1.462|1.145|<.0001
72538000|NCT03692078|144605796|EQUIVALENCE|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 7. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|1.304|||<|0.0001|TWO_SIDED|95.0|1.134|1.447|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 7. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 7. (mITT Population)||1.447|1.134|<.0001
72538001|NCT03692078|144605796|EQUIVALENCE|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 5. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|1.353|||<|0.0001|TWO_SIDED|95.0|1.194|1.513|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 5. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 5. (mITT Population)||1.513|1.194|<.0001
72538002|NCT03692078|144605796|EQUIVALENCE|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 7. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|1.313|||<|0.0001|TWO_SIDED|95.0|1.153|1.472|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 7. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 7. (mITT Population)||1.472|1.153|<.0001
72538003|NCT03692078|144605796|EQUIVALENCE|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 5. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|-0.956|||<|0.0001|TWO_SIDED|95.0|-1.155|-0.756|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 5. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 5. (mITT Population)||-0.756|-1.155|<.0001
72574022|NCT01193127|144674673|SUPERIORITY_OR_OTHER|||||||0.2||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Chi-squared, Corrected|||||||0.200
72574023|NCT01193127|144674673|SUPERIORITY_OR_OTHER|||||||0.478||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.478
72574024|NCT01193127|144674674|SUPERIORITY_OR_OTHER|||||||0.758||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.758
72574025|NCT01193127|144674674|SUPERIORITY_OR_OTHER|||||||0.521||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.521
72574026|NCT01193127|144674674|SUPERIORITY_OR_OTHER|||||||0.432||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.432
72409232|NCT01706250|144326877|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.05|STANDARD_DEVIATION|0.23||1|||||||Signed rank|||Change, in Dryness for MAXCLARITY II Vs PROACTIV: from BL to Wk 4 (within group)||||1.0000
72574027|NCT01193127|144674675|SUPERIORITY_OR_OTHER|||||||0.148||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.148
72574028|NCT01193127|144674675|SUPERIORITY_OR_OTHER|||||||0.156||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.156
72574029|NCT01193127|144674675|SUPERIORITY_OR_OTHER|||||||0.381||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.381
72574030|NCT01193127|144674676|SUPERIORITY_OR_OTHER|||||||0.646||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.646
72574031|NCT01193127|144674676|SUPERIORITY_OR_OTHER|||||||0.95||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.950
72574032|NCT01193127|144674676|SUPERIORITY_OR_OTHER|||||||0.16||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.160
72574033|NCT01193127|144674677|SUPERIORITY_OR_OTHER|||||||1||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||1.000
72627060|NCT01405196|144783277|SUPERIORITY||LS mean difference|1.92||||||90.0|-4.17|8.01||||||Week 4: Analysis was done using linear mixed effect model that included fixed factors of the stratification factors, treatment, visit, treatment by visit and baseline tender score.||8.01|-4.17|
72627061|NCT01405196|144783277|SUPERIORITY||LS mean difference|-4.2||||||90.0|-10.25|1.85||||||Week 8: Analysis was done using linear mixed effect model that included fixed factors of the stratification factors, treatment, visit, treatment by visit and baseline tender score.||1.85|-10.25|
72627062|NCT01405196|144783277|SUPERIORITY||LS mean difference|1.5|||||TWO_SIDED|90.0|-4.56|7.55||||||Week 16: Analysis was done using linear mixed effect model that included fixed factors of the stratification factors, treatment, visit, treatment by visit and baseline tender score.||7.55|-4.56|
72627063|NCT01405196|144783277|SUPERIORITY||LS mean difference|0.1|||||TWO_SIDED|90.0|-5.96|6.15||||||Week 20: Analysis was done using linear mixed effect model that included fixed factors of the stratification factors, treatment, visit, treatment by visit and baseline tender score.||6.15|-5.96|
72409233|NCT01706250|144326878|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.11|STANDARD_DEVIATION|0.46||1|||||||Signed rank|||Change, in Peeling, for MAXCLARITY II Vs PROACTIV: from BL to Wk 2 (within group)||||1.0000
72574034|NCT01193127|144674677|SUPERIORITY_OR_OTHER|||||||0.667||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.667
72574035|NCT01193127|144674677|SUPERIORITY_OR_OTHER|||||||0.303||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.303
72574036|NCT01193127|144674678|SUPERIORITY_OR_OTHER|||||||0.789||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.789
72574037|NCT01193127|144674678|SUPERIORITY_OR_OTHER|||||||0.977||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.977
72574038|NCT01193127|144674678|SUPERIORITY_OR_OTHER|||||||0.336||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.336
72574039|NCT01193127|144674679|SUPERIORITY_OR_OTHER|||||||0.632||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.632
72574040|NCT01193127|144674679|SUPERIORITY_OR_OTHER|||||||0.778||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.778
72574041|NCT01193127|144674679|SUPERIORITY_OR_OTHER|||||||0.336||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.336
72574042|NCT01193127|144674680|SUPERIORITY_OR_OTHER|||||||0.528||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.528
72574043|NCT01193127|144674680|SUPERIORITY_OR_OTHER|||||||0.362||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.362
72574044|NCT01193127|144674680|SUPERIORITY_OR_OTHER|||||||0.353||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.353
72574045|NCT01193127|144674681|SUPERIORITY_OR_OTHER|||||||0.463||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.463
72574046|NCT01193127|144674681|SUPERIORITY_OR_OTHER|||||||0.406||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.406
72627064|NCT01405196|144783277|SUPERIORITY||LS mean difference|-0.34|||||TWO_SIDED|90.0|-6.39|5.71||||||Week 24: Analysis was done using linear mixed effect model that included fixed factors of the stratification factors, treatment, visit, treatment by visit and baseline tender score.||5.71|-6.39|
72627065|NCT01405196|144783277|SUPERIORITY||LS mean difference|-2.34|||||TWO_SIDED|90.0|-8.39|3.71||||||Week 12: Analysis was done using linear mixed effect model that included fixed factors of the stratification factors, treatment, visit, treatment by visit and baseline tender score.||3.71|-8.39|
72627066|NCT01405196|144783279|SUPERIORITY||LS mean difference|0.53|||||TWO_SIDED|90.0|-2.53|3.59||||||MCS Week 4: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||3.59|-2.53|
72627067|NCT01405196|144783279|SUPERIORITY||LS mean difference|-0.48|||||TWO_SIDED|90.0|-3.54|2.58||||||MCS Week 8: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||2.58|-3.54|
72627068|NCT01405196|144783279|SUPERIORITY||LS mean difference|1.28|||||TWO_SIDED|90.0|-1.78|4.34||||||MCS Week 12: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||4.34|-1.78|
72574047|NCT01193127|144674681|SUPERIORITY_OR_OTHER|||||||0.245||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.245
72574048|NCT01193127|144674682|SUPERIORITY_OR_OTHER|||||||0.945||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.945
72574049|NCT01193127|144674682|SUPERIORITY_OR_OTHER|||||||0.438||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.438
72574050|NCT01193127|144674682|SUPERIORITY_OR_OTHER|||||||0.596||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.596
72627069|NCT01405196|144783279|SUPERIORITY||LS mean difference|1.78|||||TWO_SIDED|90.0|-1.28|4.84||||||MCS Week 16: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||4.84|-1.28|
72627070|NCT01405196|144783279|SUPERIORITY||LS mean difference|1.2|||||TWO_SIDED|90.0|-1.86|4.26||||||MCS Week 20: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||4.26|-1.86|
72574051|NCT01193127|144674683|SUPERIORITY_OR_OTHER|||||||0.811||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.811
72627071|NCT01405196|144783279|SUPERIORITY||LS mean difference|0.09|||||TWO_SIDED|90.0|-2.98|3.15||||||MCS Week 24: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||3.15|-2.98|
72627072|NCT01405196|144783279|SUPERIORITY||LS mean difference|0.0|||||TWO_SIDED|90.0|-3.03|3.03||||||MCS Week 4: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||3.03|-3.03|
72409234|NCT01706250|144326879|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.15|STANDARD_DEVIATION|0.67||0.5313||95.0|||||Signed Rank|||Change, in Redness for MAXCLARITY II Vs PROACTIV: from BL to Wk 1 (within group)||||0.5313
72409235|NCT01706250|144326879|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.16|STANDARD_DEVIATION|0.6||0.5||95.0|||||Signed Rank|||Change, in Redness for MAXCLARITY II Vs PROACTIV: from BL to Wk 2 (within group)||||0.5000
72409236|NCT01706250|144326879|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.17|STANDARD_DEVIATION|0.86||0.75|||||||Signed Rank|||Change, in Redness for MAXCLARITY II Vs PROACTIV: from BL to Wk 4 (within group)||||0.7500
72574052|NCT01193127|144674683|SUPERIORITY_OR_OTHER|||||||0.552||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.552
72574053|NCT01193127|144674683|SUPERIORITY_OR_OTHER|||||||0.549||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.549
72574054|NCT01193127|144674684|SUPERIORITY_OR_OTHER|||||||0.173||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.173
72574055|NCT01193127|144674684|SUPERIORITY_OR_OTHER|||||||0.362||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.362
72574056|NCT01193127|144674684|SUPERIORITY_OR_OTHER|||||||0.559|||||||Cochran-Mantel-Haenszel|||||||0.559
72574057|NCT01193127|144674685|SUPERIORITY_OR_OTHER|||||||0.681||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.681
72574058|NCT01193127|144674685|SUPERIORITY_OR_OTHER|||||||0.429||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.429
72574059|NCT01193127|144674685|SUPERIORITY_OR_OTHER|||||||0.306||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.306
72574060|NCT01193127|144674686|SUPERIORITY_OR_OTHER|||||||0.226||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.226
72574061|NCT01193127|144674686|SUPERIORITY_OR_OTHER|||||||0.602||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.602
72574062|NCT01193127|144674686|SUPERIORITY_OR_OTHER|||||||0.29|||||||Cochran-Mantel-Haenszel|||||||0.290
72627073|NCT01405196|144783279|SUPERIORITY||LS mean difference|-0.09|||||TWO_SIDED|90.0|-3.09|2.92||||||MCS Week 8: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||2.92|-3.09|
72627074|NCT01405196|144783279|SUPERIORITY||LS mean difference|-0.02|||||TWO_SIDED|90.0|-3.03|2.99||||||MCS Week 12: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||2.99|-3.03|
72627075|NCT01405196|144783279|SUPERIORITY||LS mean difference|-0.16|||||TWO_SIDED|90.0|-3.17|2.85||||||MCS Week 16: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||2.85|-3.17|
72627076|NCT01405196|144783279|SUPERIORITY||LS mean difference|-1.58|||||TWO_SIDED|90.0|-4.58|1.43||||||MCS Week 20: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||1.43|-4.58|
72627077|NCT01405196|144783279|SUPERIORITY||LS mean difference|-0.71|||||TWO_SIDED|90.0|-3.72|2.3||||||MCS Week 24: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||2.30|-3.72|
72627078|NCT01405196|144783279|SUPERIORITY||LS mean difference|2.67|||||TWO_SIDED|90.0|0.14|5.2||||||PCS Week 4: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||5.20|0.14|
72538004|NCT03692078|144605796|EQUIVALENCE|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 7. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|-1.114|||<|0.0001|TWO_SIDED|95.0|-1.315|-0.913|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 7. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 7. (mITT Population)||-0.913|-1.315|<.0001
72538005|NCT03692078|144605796|EQUIVALENCE|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 5. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|-0.999|||<|0.0001|TWO_SIDED|95.0|-1.195|-0.803|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 5. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 5. (mITT Population)||-0.803|-1.195|<.0001
72538006|NCT03692078|144605796|EQUIVALENCE|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 7. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|-1.164|||<|0.0001|TWO_SIDED|95.0|-1.364|-0.964|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 7. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 7. (mITT Population)||-0.964|-1.364|<.0001
72538007|NCT03692078|144605796|EQUIVALENCE|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 5. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|-0.775|||<|0.0001|TWO_SIDED|95.0|-0.969|-0.582|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 5. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 5. (mITT Population)||-0.582|-0.969|<.0001
72538008|NCT03692078|144605796|EQUIVALENCE|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 7. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|-0.795|||<|0.0001|TWO_SIDED|95.0|-0.99|-0.6|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 7. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 7. (mITT Population)||-0.600|-0.990|<.0001
72538009|NCT03692078|144605796|EQUIVALENCE|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 5. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-0.514||||0.0002|TWO_SIDED|95.0|-0.836|-0.193|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 5. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 5. (mITT Population)||-0.193|-0.836|0.0002
72538010|NCT03692078|144605796|EQUIVALENCE|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 7. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-0.484||||0.0005|TWO_SIDED|95.0|-0.808|-0.16|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 7. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 7. (mITT Population)||-0.160|-0.808|0.0005
72538011|NCT03692078|144605796|EQUIVALENCE|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 5. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-0.452||||0.0014|TWO_SIDED|95.0|-0.775|-0.128|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 5. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 5. (mITT Population)||-0.128|-0.775|0.0014
72627079|NCT01405196|144783279|SUPERIORITY||LS mean difference|3.36|||||TWO_SIDED|90.0|0.84|5.89||||||PCS Week 8: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||5.89|0.84|
72627080|NCT01405196|144783279|SUPERIORITY||LS mean difference|3.23|||||TWO_SIDED|90.0|0.7|5.76||||||PCS Week 12: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||5.76|0.70|
72627081|NCT01405196|144783279|SUPERIORITY||LS mean difference|3.77|||||TWO_SIDED|90.0|1.24|6.3||||||PCS Week 16: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||6.30|1.24|
72574063|NCT01193127|144674687|SUPERIORITY_OR_OTHER|||||||0.244||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.244
72574064|NCT01193127|144674687|SUPERIORITY_OR_OTHER|||||||0.122||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.122
72538012|NCT03692078|144605796|EQUIVALENCE|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 7. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-0.475||||0.0007|TWO_SIDED|95.0|-0.799|-0.152|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 7. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 7. (mITT Population)||-0.152|-0.799|0.0007
72538013|NCT03692078|144605796|EQUIVALENCE|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 5. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-2.76|||<|0.0001|TWO_SIDED|95.0|-3.127|-2.394|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 5. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 5. (mITT Population)||-2.394|-3.127|<.0001
72574065|NCT01193127|144674687|SUPERIORITY_OR_OTHER|||||||0.79||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.790
72574066|NCT01193127|144674688|SUPERIORITY_OR_OTHER|||||||0.752||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.752
72574067|NCT01193127|144674688|SUPERIORITY_OR_OTHER|||||||0.355||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.355
72574068|NCT01193127|144674688|SUPERIORITY_OR_OTHER|||||||0.292||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.292
72574069|NCT01193127|144674689|SUPERIORITY_OR_OTHER|||||||0.228||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.228
72574070|NCT01193127|144674689|SUPERIORITY_OR_OTHER|||||||0.564||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.564
72574071|NCT01193127|144674689|SUPERIORITY_OR_OTHER|||||||0.755||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.755
72409237|NCT01706250|144326879|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.33|STANDARD_DEVIATION|0.84||0.25|||||||Signed rank|||Change, in Redness for MAXCLARITY II Vs PROACTIV: from BL to Wk 8 (within group)||||0.2500
72574072|NCT01193127|144674690|SUPERIORITY_OR_OTHER|||||||0.018||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.018
72574073|NCT01193127|144674690|SUPERIORITY_OR_OTHER|||||||0.292||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.292
72574074|NCT01193127|144674690|SUPERIORITY_OR_OTHER|||||||0.298||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.298
72574075|NCT01193127|144674691|SUPERIORITY_OR_OTHER|||||||0.271||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.271
72574076|NCT01193127|144674691|SUPERIORITY_OR_OTHER|||||||0.345||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.345
72574077|NCT01193127|144674691|SUPERIORITY_OR_OTHER|||||||0.096||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.096
72574078|NCT01193127|144674692|SUPERIORITY_OR_OTHER|||||||0.32||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.320
72574079|NCT01193127|144674692|SUPERIORITY_OR_OTHER|||||||0.39||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.390
72574080|NCT01193127|144674692|SUPERIORITY_OR_OTHER|||||||0.23||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.230
72574081|NCT01193127|144674693|SUPERIORITY_OR_OTHER|||||||0.778||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.778
72574082|NCT01193127|144674693|SUPERIORITY_OR_OTHER|||||||0.348||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.348
72574083|NCT01193127|144674693|SUPERIORITY_OR_OTHER|||||||0.477||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.477
72538014|NCT03692078|144605796|EQUIVALENCE|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 7. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-2.902|||<|0.0001|TWO_SIDED|95.0|-3.271|-2.533|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 7. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 7. (mITT Population)||-2.533|-3.271|<.0001
72538015|NCT03692078|144605796|EQUIVALENCE|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 5. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-2.804|||<|0.0001|TWO_SIDED|95.0|-3.165|-2.443|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 5. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 5. (mITT Population)||-2.443|-3.165|<.0001
72538016|NCT03692078|144605796|EQUIVALENCE|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 7. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-2.952|||<|0.0001|TWO_SIDED|95.0|-3.317|-2.587|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 7. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 7. (mITT Population)||-2.587|-3.317|<.0001
72538017|NCT03692078|144605796|EQUIVALENCE|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 5. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|2.066|||<|0.0001|TWO_SIDED|95.0|1.719|2.413|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 5. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 5. (mITT Population)||2.413|1.719|<.0001
72538018|NCT03692078|144605796|EQUIVALENCE|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 7. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|2.099|||<|0.0001|TWO_SIDED|95.0|1.748|2.449|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 7. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 7. (mITT Population)||2.449|1.748|<.0001
72538019|NCT03692078|144605796|EQUIVALENCE|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 5. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|2.129|||<|0.0001|TWO_SIDED|95.0|1.779|2.478|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 5. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 5. (mITT Population)||2.478|1.779|<.0001
72538020|NCT03692078|144605796|EQUIVALENCE|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 7. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|2.107|||<|0.0001|TWO_SIDED|95.0|1.756|2.459|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 7. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 7. (mITT Population)||2.459|1.756|<.0001
72538021|NCT03692078|144605796|EQUIVALENCE|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 5. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|-0.18||||0.7678|TWO_SIDED|95.0|-0.569|0.209|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 5. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 5. (mITT Population)||0.209|-0.569|0.7678
72574084|NCT01193127|144674694|SUPERIORITY_OR_OTHER|||||||0.374||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.374
72574085|NCT01193127|144674694|SUPERIORITY_OR_OTHER|||||||0.265||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.265
72627082|NCT01405196|144783279|SUPERIORITY||LS mean difference|3.1|||||TWO_SIDED|90.0|0.57|5.63||||||PCS Week 20: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||5.63|0.57|
72627083|NCT01405196|144783279|SUPERIORITY||LS mean difference|3.03||||||90.0|0.5|5.56||||||PCS Week 24: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||5.56|0.50|
72627084|NCT01405196|144783279|SUPERIORITY||LS mean difference|1.96|||||TWO_SIDED|90.0|-0.53|4.46||||||PCS Week 4: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||4.46|-0.53|
72627085|NCT01405196|144783279|SUPERIORITY||LS mean difference|2.68||||||90.0|0.2|5.17||||||PCS Week 8: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||5.17|0.20|
72627086|NCT01405196|144783279|SUPERIORITY||LS mean difference|1.84|||||TWO_SIDED|90.0|-0.65|4.32||||||PCS Week 12: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||4.32|-0.65|
72538022|NCT03692078|144605796|EQUIVALENCE|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 7. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|-0.319||||0.1691|TWO_SIDED|95.0|-0.711|0.073|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 7. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 7. (mITT Population)||0.073|-0.711|0.1691
72538023|NCT03692078|144605796|EQUIVALENCE|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 5. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|-0.224||||0.5178|TWO_SIDED|95.0|-0.606|0.158|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 5. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 5. (mITT Population)||0.158|-0.606|0.5178
72538024|NCT03692078|144605796|EQUIVALENCE|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 7. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|-0.369||||0.0699|TWO_SIDED|95.0|-0.757|0.018|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 7. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 7. (mITT Population)||0.018|-0.757|0.0699
72538025|NCT03692078|144605798|EQUIVALENCE|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 5. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|6.177|||<|0.0001|TWO_SIDED|95.0|6.062|6.292|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 5. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 5. (mITT Population)||6.292|6.062|<.0001
72538026|NCT03692078|144605798|EQUIVALENCE|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 7. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|6.197|||<|0.0001|TWO_SIDED|95.0|6.082|6.312|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 7. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 7. (mITT Population)||6.312|6.082|<.0001
72627087|NCT01405196|144783279|SUPERIORITY||LS mean difference|2.01|||||TWO_SIDED|90.0|-0.47|4.5||||||PCS Week 16: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||4.50|-0.47|
72627088|NCT01405196|144783279|SUPERIORITY||LS mean difference|2.34|||||TWO_SIDED|90.0|-0.15|4.82||||||PCS Week 20: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||4.82|-0.15|
72627089|NCT01405196|144783279|SUPERIORITY||LS mean difference|2.59|||||TWO_SIDED|90.0|0.11|5.08||||||PCS Week 24: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||5.08|0.11|
72627090|NCT01405196|144783280|SUPERIORITY||LS mean difference|0.47||||||90.0|-6.33|7.27||||||Week 4: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||7.27|-6.33|
72627091|NCT01405196|144783280|SUPERIORITY||LS mean difference|3.92||||||90.0|-2.88|10.72||||||Week 8: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||10.72|-2.88|
72627092|NCT01405196|144783280|SUPERIORITY||LS mean difference|3.55|||||TWO_SIDED|90.0|-3.25|10.36||||||Week 12: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||10.36|-3.25|
72627093|NCT01405196|144783280|SUPERIORITY||LS mean difference|7.85|||||TWO_SIDED|90.0|1.05|14.66||||||Week 16: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||14.66|1.05|
72627094|NCT01405196|144783280|SUPERIORITY||LS mean difference|7.12|||||TWO_SIDED|90.0|0.32|13.92||||||Week 20: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||13.92|0.32|
72538027|NCT03692078|144605798|EQUIVALENCE|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 5. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|5.798|||<|0.0001|TWO_SIDED|95.0|5.69|5.906|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 5. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 5. (mITT Population)||5.906|5.690|<.0001
72538028|NCT03692078|144605798|EQUIVALENCE|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 7. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|5.82|||<|0.0001|TWO_SIDED|95.0|5.71|5.93|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 7. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 7. (mITT Population)||5.930|5.710|<.0001
72538029|NCT03692078|144605798|EQUIVALENCE|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 5. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|5.863|||<|0.0001|TWO_SIDED|95.0|5.753|5.974|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 5. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 5. (mITT Population)||5.974|5.753|<.0001
72538030|NCT03692078|144605798|EQUIVALENCE|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 7. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|5.816|||<|0.0001|TWO_SIDED|95.0|5.706|5.927|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 7. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 7. (mITT Population)||5.927|5.706|<.0001
72538031|NCT03692078|144605798|EQUIVALENCE|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 5. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|4.947|||<|0.0001|TWO_SIDED|95.0|4.809|5.084|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 5. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 5. (mITT Population)||5.084|4.809|<.0001
72538032|NCT03692078|144605798|EQUIVALENCE|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 7. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|4.913|||<|0.0001|TWO_SIDED|95.0|4.774|5.052|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 7. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 7. (mITT Population)||5.052|4.774|<.0001
72538033|NCT03692078|144605798|EQUIVALENCE|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 5. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|4.862|||<|0.0001|TWO_SIDED|95.0|4.727|4.998|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 5. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 5. (mITT Population)||4.998|4.727|<.0001
72627095|NCT01405196|144783280|SUPERIORITY||LS mean difference|4.33|||||TWO_SIDED|90.0|-2.47|11.13||||||Week 24: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||11.13|-2.47|
72538034|NCT03692078|144605798|EQUIVALENCE|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 7. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|4.938|||<|0.0001|TWO_SIDED|95.0|4.799|5.076|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 7. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 7. (mITT Population)||5.076|4.799|<.0001
72627096|NCT01405196|144783280|SUPERIORITY||LS mean difference|1.33|||||TWO_SIDED|90.0|-5.4|8.05||||||Week 4: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||8.05|-5.40|
72627097|NCT01405196|144783280|SUPERIORITY||LS mean difference|3.93|||||TWO_SIDED|90.0|-2.75|10.62||||||Week 8: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||10.62|-2.75|
72409238|NCT01706250|144326880|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.3|STANDARD_DEVIATION|0.86||0.2131|||||||Signed Rank)|||Change, in Dryness for MAXCLARITY II Vs PROACTIV: from BL to Wk 1 (within group)||||0.2131
72627098|NCT01405196|144783280|SUPERIORITY||LS mean difference|-0.78|||||TWO_SIDED|90.0|-7.47|5.91||||||Week 12: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||5.91|-7.47|
72538035|NCT03692078|144605798|EQUIVALENCE|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 5. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|4.826|||<|0.0001|TWO_SIDED|95.0|4.693|4.959|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 5. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 5. (mITT Population)||4.959|4.693|<.0001
72538036|NCT03692078|144605798|EQUIVALENCE|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 7. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|4.902|||<|0.0001|TWO_SIDED|95.0|4.767|5.037|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 7. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 7. (mITT Population)||5.037|4.767|<.0001
72538037|NCT03692078|144605798|EQUIVALENCE|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 5. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-0.379|||<|0.0001|TWO_SIDED|95.0|-0.602|-0.156|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 5. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 5. (mITT Population)||-0.156|-0.602|<.0001
72538038|NCT03692078|144605798|EQUIVALENCE|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 7. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-0.376|||<|0.0001|TWO_SIDED|95.0|-0.601|-0.152|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 7. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 7. (mITT Population)||-0.152|-0.601|<.0001
72538039|NCT03692078|144605798|EQUIVALENCE|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 5. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-0.314||||0.0014|TWO_SIDED|95.0|-0.537|-0.09|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 5. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 5. (mITT Population)||-0.090|-0.537|0.0014
72538040|NCT03692078|144605798|EQUIVALENCE|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 7. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-0.381|||<|0.0001|TWO_SIDED|95.0|-0.604|-0.157|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 7. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 7. (mITT Population)||-0.157|-0.604|<.0001
72538041|NCT03692078|144605798|EQUIVALENCE|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 5. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-1.23|||<|0.0001|TWO_SIDED|95.0|-1.484|-0.977|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 5. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 5. (mITT Population)||-0.977|-1.484|<.0001
72574086|NCT01193127|144674694|SUPERIORITY_OR_OTHER|||||||0.555||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.555
72574087|NCT01193127|144674695|SUPERIORITY_OR_OTHER|||||||0.031||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.031
72574088|NCT01193127|144674695|SUPERIORITY_OR_OTHER|||||||0.059||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.059
72574089|NCT01193127|144674695|SUPERIORITY_OR_OTHER|||||||0.472||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.472
72574090|NCT01193127|144674696|SUPERIORITY_OR_OTHER|||||||0.476||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.476
72574091|NCT01193127|144674696|SUPERIORITY_OR_OTHER|||||||0.169||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.169
72409239|NCT01706250|144326880|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.37|STANDARD_DEVIATION|1.16||0.2656||95.0|||||Signed Rank|||Change, in Dryness for MAXCLARITY II Vs PROACTIV: from BL to Wk 2 (within group)||||0.2656
72538042|NCT03692078|144605798|EQUIVALENCE|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 7. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-1.284|||<|0.0001|TWO_SIDED|95.0|-1.539|-1.029|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 7. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 7. (mITT Population)||-1.029|-1.539|<.0001
72538043|NCT03692078|144605798|EQUIVALENCE|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 5. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-1.315|||<|0.0001|TWO_SIDED|95.0|-1.564|-1.065|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 5. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 5. (mITT Population)||-1.065|-1.564|<.0001
72538044|NCT03692078|144605798|EQUIVALENCE|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 7. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-1.259|||<|0.0001|TWO_SIDED|95.0|-1.512|-1.006|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 7. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 7. (mITT Population)||-1.006|-1.512|<.0001
72538045|NCT03692078|144605798|EQUIVALENCE|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 5. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|0.972|||<|0.0001|TWO_SIDED|95.0|0.732|1.211|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 5. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 5. (mITT Population)||1.211|0.732|<.0001
72538046|NCT03692078|144605798|EQUIVALENCE|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 7. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|0.918|||<|0.0001|TWO_SIDED|95.0|0.676|1.161|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 7. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 7. (mITT Population)||1.161|0.676|<.0001
72538047|NCT03692078|144605798|EQUIVALENCE|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 5. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|1.037|||<|0.0001|TWO_SIDED|95.0|0.797|1.278|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 5. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 5. (mITT Population)||1.278|0.797|<.0001
72574092|NCT01193127|144674696|SUPERIORITY_OR_OTHER|||||||0.31||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.310
72574093|NCT01193127|144674697|SUPERIORITY_OR_OTHER|||||||0.075||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.075
72574094|NCT01193127|144674697|SUPERIORITY_OR_OTHER|||||||0.005||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.005
72574095|NCT01193127|144674697|SUPERIORITY_OR_OTHER|||||||0.078||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.078
72574096|NCT01193127|144674698|SUPERIORITY_OR_OTHER|||||||0.226||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.226
72574097|NCT01193127|144674698|SUPERIORITY_OR_OTHER|||||||0.357||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.357
72409240|NCT01706250|144326880|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.28|STANDARD_DEVIATION|0.75||0.2344||95.0|||||Signed Rank|||Change, in Dryness for MAXCLARITY II Vs PROACTIV: from BL to Wk 4 (within group)||||0.2344
72409241|NCT01706250|144326880|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.22|STANDARD_DEVIATION|0.73||0.3594||95.0|||||Signed Rank|||Change, in Dryness for MAXCLARITY II Vs PROACTIV: from BL to Wk 8 (within group)||||0.3594
72538048|NCT03692078|144605798|EQUIVALENCE|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 7. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|0.914|||<|0.0001|TWO_SIDED|95.0|0.672|1.156|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 7. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 7. (mITT Population)||1.156|0.672|<.0001
72538049|NCT03692078|144605798|EQUIVALENCE|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 5. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|0.121||||0.7939|TWO_SIDED|95.0|-0.147|0.388|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 5. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 5. (mITT Population)||0.388|-0.147|0.7939
72538050|NCT03692078|144605798|EQUIVALENCE|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 7. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|0.011||||1|TWO_SIDED|95.0|-0.26|0.281|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 7. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 7. (mITT Population)||0.281|-0.260|1.0000
72538051|NCT03692078|144605798|EQUIVALENCE|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 5. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|0.036||||1|TWO_SIDED|95.0|-0.228|0.301|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 5. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 5. (mITT Population)||0.301|-0.228|1.0000
72538052|NCT03692078|144605798|EQUIVALENCE|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 7. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|0.036||||1|TWO_SIDED|95.0|-0.233|0.305|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 7. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 7. (mITT Population)||0.305|-0.233|1.0000
72538053|NCT03692078|144605800|EQUIVALENCE|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 5. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|7.367|||<|0.0001|TWO_SIDED|95.0|7.25|7.485|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 5. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 5. (mITT Population)||7.485|7.250|<.0001
72574098|NCT01193127|144674698|SUPERIORITY_OR_OTHER|||||||0.291||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.291
72574099|NCT01193127|144674699|SUPERIORITY_OR_OTHER|||||||0.172||||||Treatment comparisons between OMS302 and each of the other three groups are based on Wilcoxon rank-sum test.|Wilcoxon rank-sum test|||||||0.172
72574100|NCT01193127|144674699|SUPERIORITY_OR_OTHER|||||||0.547||||||Treatment comparisons between OMS302 and each of the other three groups are based on Wilcoxon rank-sum test.|Wilcoxon rank-sum test|||||||0.547
72574101|NCT01193127|144674699|SUPERIORITY_OR_OTHER|||||||0.921||||||Treatment comparisons between OMS302 and each of the other three groups are based on Wilcoxon rank-sum test.|Wicoxon rank-sum test|||||||0.921
72574102|NCT01193127|144674700|SUPERIORITY_OR_OTHER|||||||0.701||||||Treatment comparisons between OMS302 and each of the other three groups are based on Wilcoxon rank-sum test.|Wilcoxon rank-sum test|||||||0.701
72574103|NCT01193127|144674700|SUPERIORITY_OR_OTHER|||||||0.089||||||Treatment comparisons between OMS302 and each of the other three groups are based on Wilcoxon rank-sum test.|Wilcoxon rank-sum test|||||||0.089
72574104|NCT01193127|144674700|SUPERIORITY_OR_OTHER|||||||0.095||||||Treatment comparisons between OMS302 and each of the other three groups are based on Wilcoxon rank-sum test.|Wilcoxon rank-sum test|||||||0.095
72627099|NCT01405196|144783280|SUPERIORITY||LS mean difference|3.67||||||90.0|-3.02|10.35||||||Week 16: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||10.35|-3.02|
72574105|NCT01193127|144674701|SUPERIORITY_OR_OTHER|||||||0.086||||||Treatment comparisons between OMS302 and each of the other three groups are based on Wilcoxon rank-sum test.|Wilcoxon rank-sum test|||||||0.086
72574106|NCT01193127|144674701|SUPERIORITY_OR_OTHER|||||||0.092||||||Treatment comparisons between OMS302 and each of the other three groups are based on Wilcoxon rank-sum test.|Wicoxon rank-sum test|||||||0.092
72627100|NCT01405196|144783280|SUPERIORITY||LS mean difference|2.99|||||TWO_SIDED|90.0|-3.7|9.68||||||Week 20: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||9.68|-3.70|
72627101|NCT01405196|144783280|SUPERIORITY||LS mean difference|1.44|||||TWO_SIDED|90.0|-5.24|8.13||||||Week 24: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||8.13|-5.24|
72538054|NCT03692078|144605800|EQUIVALENCE|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 7. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|7.368|||<|0.0001|TWO_SIDED|95.0|7.251|7.485|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 7. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 7. (mITT Population)||7.485|7.251|<.0001
72574107|NCT01193127|144674701|SUPERIORITY_OR_OTHER|||||||0.12||||||Treatment comparisons between OMS302 and each of the other three groups are based on Wilcoxon rank-sum test.|Wilcoxon rank-sum test|||||||0.120
72574108|NCT01193127|144674702|SUPERIORITY_OR_OTHER|||||||0.626||||||Treatment comparisons between OMS302 and each of the other three groups are based on Wilcoxon rank-sum test.|Wilcoxon rank-sum test|||||||0.626
72574109|NCT01193127|144674702|SUPERIORITY_OR_OTHER|||||||0.736||||||Treatment comparisons between OMS302 and each of the other three groups are based on Wilcoxon rank-sum test.|Wilcoxon rank-sum test|||||||0.736
72574110|NCT01193127|144674702|SUPERIORITY_OR_OTHER|||||||0.725||||||Treatment comparisons between OMS302 and each of the other three groups are based on Wilcoxon rank-sum test.|Wilcoxon rank-sum test|||||||0.725
72574111|NCT01193127|144674703|SUPERIORITY_OR_OTHER|||||||0.22||||||Treatment comparisons between OMS302 and each of the other three groups are based on Wilcoxon rank-sum test.|Wilcoxon rank-sum test|||||||0.220
72574112|NCT01193127|144674703|SUPERIORITY_OR_OTHER|||||||0.903||||||Treatment comparisons between OMS302 and each of the other three groups are based on Wilcoxon rank-sum test.|Wilcoxon rank-sum test|||||||0.903
72574113|NCT01193127|144674703|SUPERIORITY_OR_OTHER|||||||0.463||||||Treatment comparisons between OMS302 and each of the other three groups are based on Wilcoxon rank-sum test.|Wilcoxon rank-sum test|||||||0.463
72574114|NCT01193127|144674704|SUPERIORITY_OR_OTHER|||||||0.675||||||Treatment comparisons between OMS302 and each of the other three groups are based on Wilcoxon rank-sum test.|Wilcoxon rank-sum test|||||||0.675
72574115|NCT01193127|144674704|SUPERIORITY_OR_OTHER|||||||0.825||||||Treatment comparisons between OMS302 and each of the other three groups are based on Wilcoxon rank-sum test.|WIlcoxon rank-sum test|||||||0.825
72574116|NCT01193127|144674704|SUPERIORITY_OR_OTHER|||||||0.668||||||Treatment comparisons between OMS302 and each of the other three groups are based on Wilcoxon rank-sum test.|Wilcoxon rank-sum test|||||||0.668
72574117|NCT01193127|144674705|SUPERIORITY_OR_OTHER|||||||0.2066||||||Treatment comparisons between OMS302 and each of the other three groups are based on ANOVA model with covariates treatment group and the LOCS II grade group.|ANOVA|||||||0.2066
72574118|NCT01193127|144674705|SUPERIORITY_OR_OTHER|||||||0.2066||||||Treatment comparisons between OMS302 and each of the other three groups are based on ANOVA model with covariates treatment group and the LOCS II grade group.|ANOVA|||||||0.2066
72574119|NCT01193127|144674705|SUPERIORITY_OR_OTHER|||||||0.5263||||||Treatment comparisons between OMS302 and each of the other three groups are based on ANOVA model with covariates treatment group and the LOCS II grade group.|ANOVA|||||||0.5263
72574120|NCT01193127|144674706|SUPERIORITY_OR_OTHER|||||||0.4222||||||Treatment comparisons between OMS302 and each of the other three groups are based on ANOVA model with covariates treatment group and the LOCS II grade group.|ANOVA|||||||0.4222
72574121|NCT01193127|144674706|SUPERIORITY_OR_OTHER|||||||0.2712||||||Treatment comparisons between OMS302 and each of the other three groups are based on ANOVA model with covariates treatment group and the LOCS II grade group.|ANOVA|||||||0.2712
72574122|NCT01193127|144674706|SUPERIORITY_OR_OTHER|||||||0.8819||||||Treatment comparisons between OMS302 and each of the other three groups are based on ANOVA model with covariates treatment group and the LOCS II grade group.|ANOVA|||||||0.8819
72574123|NCT01193127|144674707|SUPERIORITY_OR_OTHER|||||||0.051||||||Treatment comparisons between OMS302 and each of the other three groups are based on ANOVA model with covariates treatment group and the LOCS II grade group.|ANOVA|||||||0.0510
72574124|NCT01193127|144674707|SUPERIORITY_OR_OTHER|||||||0.8084||||||Treatment comparisons between OMS302 and each of the other three groups are based on ANOVA model with covariates treatment group and the LOCS II grade group.|ANOVA|||||||0.8084
72574125|NCT01193127|144674707|SUPERIORITY_OR_OTHER|||||||0.1495||||||Treatment comparisons between OMS302 and each of the other three groups are based on ANOVA model with covariates treatment group and the LOCS II grade group.|ANOVA|||||||0.1495
72574126|NCT01193127|144674708|SUPERIORITY_OR_OTHER|||||||0.4099||||||Treatment comparisons between OMS302 and each of the other three groups are based on ANOVA model with covariates treatment group and the LOCS II grade group.|ANOVA|||||||0.4099
72574127|NCT01193127|144674708|SUPERIORITY_OR_OTHER|||||||0.6499||||||Treatment comparisons between OMS302 and each of the other three groups are based on ANOVA model with covariates treatment group and the LOCS II grade group.|ANOVA|||||||0.6499
72574128|NCT01193127|144674708|SUPERIORITY_OR_OTHER|||||||0.0765||||||Treatment comparisons between OMS302 and each of the other three groups are based on ANOVA model with covariates treatment group and the LOCS II grade group.|ANOVA|||||||0.0765
72574129|NCT01193127|144674709|SUPERIORITY_OR_OTHER|||||||0.0688||||||Treatment comparisons between OMS302 and each of the other three groups are based on ANOVA model with covariates treatment group and the LOCS II grade group.|ANOVA|||||||0.0688
72574130|NCT01193127|144674709|SUPERIORITY_OR_OTHER|||||||0.0314||||||Treatment comparisons between OMS302 and each of the other three groups are based on ANOVA model with covariates treatment group and the LOCS II grade group.|ANOVA|||||||0.0314
72574131|NCT01193127|144674709|SUPERIORITY_OR_OTHER|||||||0.0775||||||Treatment comparisons between OMS302 and each of the other three groups are based on ANOVA model with covariates treatment group and the LOCS II grade group.|ANOVA|||||||0.0775
72574132|NCT01193127|144674710|SUPERIORITY_OR_OTHER|||||||0.5369||||||Treatment comparisons between OMS302 and each of the other three groups are based on ANOVA model with covariates treatment group and the LOCS II grade group.|ANOVA|||||||0.5369
72574133|NCT01193127|144674710|SUPERIORITY_OR_OTHER|||||||0.3763||||||Treatment comparisons between OMS302 and each of the other three groups are based on ANOVA model with covariates treatment group and the LOCS II grade group.|ANOVA|||||||0.3763
72574134|NCT01193127|144674710|SUPERIORITY_OR_OTHER|||||||0.6144||||||Treatment comparisons between OMS302 and each of the other three groups are based on ANOVA model with covariates treatment group and the LOCS II grade group.|ANOVA|||||||0.6144
72574135|NCT01193127|144674711|SUPERIORITY_OR_OTHER|||||||0.1374||||||Treatment comparisons between OMS302 and each of the other three groups are based on ANOVA model with covariates treatment group and the LOCS II grade group.|ANOVA|||||||0.1374
72574136|NCT01193127|144674711|SUPERIORITY_OR_OTHER|||||||0.9146||||||Treatment comparisons between OMS302 and each of the other three groups are based on ANOVA model with covariates treatment group and the LOCS II grade group.|ANOVA|||||||0.9146
72574137|NCT01193127|144674711|SUPERIORITY_OR_OTHER|||||||0.7599||||||Treatment comparisons between OMS302 and each of the other three groups are based on ANOVA model with covariates treatment group and the LOCS II grade group.|ANOVA|||||||0.7599
72574138|NCT01193127|144674712|SUPERIORITY_OR_OTHER|||||||0.317||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.317
72574139|NCT01193127|144674712|SUPERIORITY_OR_OTHER|||||||0.317||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.317
72574140|NCT01193127|144674712|SUPERIORITY_OR_OTHER|||||||1||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||1.000
72574141|NCT01193127|144674713|SUPERIORITY_OR_OTHER|||||||0.559||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.559
72627102|NCT01405196|144783281|SUPERIORITY||LS mean difference|0.53|||||TWO_SIDED|90.0|-2.53|3.59||||||MCS Week 4: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||3.59|-2.53|
72627103|NCT01405196|144783281|SUPERIORITY||LS mean difference|-0.48|||||TWO_SIDED|90.0|-3.54|2.58||||||MCS Week 8: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||2.58|-3.54|
72627104|NCT01405196|144783281|SUPERIORITY||LS mean difference|1.28|||||TWO_SIDED|90.0|-1.78|4.34||||||MCS Week 12: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||4.34|-1.78|
72409242|NCT01706250|144326881|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.2|STANDARD_DEVIATION|1.32||0.6172|||||||Signed Rank|||Change, in Burning for MAXCLARITY II Vs PROACTIV: from BL to Wk 1 (within group)||||0.6172
72409243|NCT01706250|144326881|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.26|STANDARD_DEVIATION|0.93||0.3984|||||||Signed Rank|||Change, in Burning for MAXCLARITY II Vs PROACTIV: from BL to Wk 2 (within group)||||0.3984
72409244|NCT01706250|144326881|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.56|STANDARD_DEVIATION|1.1||0.0781||95.0|||||Signed Rank|||Change, in Burning for MAXCLARITY II Vs PROACTIV: from BL to Wk 4 (within group)||||0.0781
72574142|NCT01193127|144674713|SUPERIORITY_OR_OTHER|||||||0.647||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.647
72574143|NCT01193127|144674713|SUPERIORITY_OR_OTHER|||||||0.559||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.559
72574144|NCT01193127|144674714|SUPERIORITY_OR_OTHER|||||||0.317||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.317
72574145|NCT01193127|144674714|SUPERIORITY_OR_OTHER|||||||0.335||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.335
72574146|NCT01193127|144674714|SUPERIORITY_OR_OTHER|||||||0.317||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.317
72574147|NCT01193127|144674715|SUPERIORITY_OR_OTHER|||||||1||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||1.000
72574148|NCT01193127|144674715|SUPERIORITY_OR_OTHER|||||||0.559||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.559
72574149|NCT01193127|144674715|SUPERIORITY_OR_OTHER|||||||1||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||1.000
72574150|NCT01193127|144674716|SUPERIORITY_OR_OTHER|||||||0.824||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.824
72574151|NCT01193127|144674716|SUPERIORITY_OR_OTHER|||||||0.476||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.476
72574152|NCT01193127|144674716|SUPERIORITY_OR_OTHER|||||||0.281||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.281
72574153|NCT01193127|144674717|SUPERIORITY_OR_OTHER|||||||0.842||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.842
72574154|NCT01193127|144674717|SUPERIORITY_OR_OTHER|||||||0.619||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.619
72574155|NCT01193127|144674717|SUPERIORITY_OR_OTHER|||||||0.711||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.711
72627105|NCT01405196|144783281|SUPERIORITY||LS mean difference|1.78|||||TWO_SIDED|90.0|-1.28|4.84||||||MCS Week 16: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||4.84|-1.28|
72627106|NCT01405196|144783281|SUPERIORITY||LS mean difference|1.2|||||TWO_SIDED|90.0|-1.86|4.26||||||MCS Week 20: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||4.26|-1.86|
72627107|NCT01405196|144783281|SUPERIORITY||LS mean difference|0.09|||||TWO_SIDED|90.0|-2.98|3.15||||||MCS Week 24: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||3.15|-2.98|
72574156|NCT01193127|144674718|SUPERIORITY_OR_OTHER|||||||0.773||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.773
72574157|NCT01193127|144674718|SUPERIORITY_OR_OTHER|||||||0.592||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.592
72574158|NCT01193127|144674718|SUPERIORITY_OR_OTHER|||||||0.787||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.787
72574159|NCT01193127|144674719|SUPERIORITY_OR_OTHER|||||||0.695||||||Treatment comparisons between OMS302 and each of the other three groups were based on Wilcoxon rank-sum test. For subjects with mean count \> 30, the mean count was imputed as 45 for the purpose of treatment comparisons.|Wilcoxon rank-sum test|||||||0.695
72574160|NCT01193127|144674719|SUPERIORITY_OR_OTHER|||||||0.166||||||Treatment comparisons between OMS302 and each of the other three groups were based on Wilcoxon rank-sum test. For subjects with mean count \> 30, the mean count was imputed as 45 for the purpose of treatment comparisons.|Wilcoxon rank-sum test|||||||0.166
72574161|NCT01193127|144674719|SUPERIORITY_OR_OTHER|||||||0.987||||||Treatment comparisons between OMS302 and each of the other three groups were based on Wilcoxon rank-sum test. For subjects with mean count \> 30, the mean count was imputed as 45 for the purpose of treatment comparisons.|Wilcoxon rank-sum test|||||||0.987
72574162|NCT01193127|144674720|SUPERIORITY_OR_OTHER|||||||0.134||||||Treatment comparisons between OMS302 and each of the other three groups were based on Wilcoxon rank-sum test. For subjects with mean count \> 30, the mean count was imputed as 45 for the purpose of treatment comparisons.|Wilcoxon rank-sum test|||||||0.134
72574163|NCT01193127|144674720|SUPERIORITY_OR_OTHER|||||||0.71||||||Treatment comparisons between OMS302 and each of the other three groups were based on Wilcoxon rank-sum test. For subjects with mean count \> 30, the mean count was imputed as 45 for the purpose of treatment comparisons.|Wilcoxon rank-sum test|||||||0.710
72574164|NCT01193127|144674720|SUPERIORITY_OR_OTHER|||||||0.31||||||Treatment comparisons between OMS302 and each of the other three groups were based on Wilcoxon rank-sum test. For subjects with mean count \> 30, the mean count was imputed as 45 for the purpose of treatment comparisons.|Wilcoxon rank-sum test|||||||0.310
72627108|NCT01405196|144783281|SUPERIORITY||LS mean difference|0.0|||||TWO_SIDED|90.0|-3.03|3.03||||||MCS Week 4: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||3.03|-3.03|
72409245|NCT01706250|144326881|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.39|STANDARD_DEVIATION|1.24||0.375||95.0|||||Signed Rank|||Change, in Burning for MAXCLARITY II Vs PROACTIV: from BL to Wk 8 (within group)||||0.3750
72574165|NCT01193127|144674721|SUPERIORITY_OR_OTHER|||||||0.086||||||Treatment comparisons between OMS302 and each of the other three groups were based on Wilcoxon rank-sum test. For subjects with mean count \> 30, the mean count was imputed as 45 for the purpose of treatment comparisons.|Wilcoxon rank-sum test|||||||0.086
72574166|NCT01193127|144674721|SUPERIORITY_OR_OTHER|||||||0.183||||||Treatment comparisons between OMS302 and each of the other three groups were based on Wilcoxon rank-sum test. For subjects with mean count \> 30, the mean count was imputed as 45 for the purpose of treatment comparisons.|Wilcoxon rank-sum test|||||||0.183
72574167|NCT01193127|144674721|SUPERIORITY_OR_OTHER|||||||0.029||||||Treatment comparisons between OMS302 and each of the other three groups were based on Wilcoxon rank-sum test. For subjects with mean count \> 30, the mean count was imputed as 45 for the purpose of treatment comparisons.|Wilcoxon rank-sum test|||||||0.029
72574168|NCT01193127|144674722|SUPERIORITY_OR_OTHER|||||||0.206||||||Treatment comparisons between OMS302 and each of the other three groups were based on Wilcoxon rank-sum test. For subjects with mean count \> 30, the mean count was imputed as 45 for the purpose of treatment comparisons.|Wilcoxon rank-sum test|||||||0.206
72574169|NCT01193127|144674722|SUPERIORITY_OR_OTHER|||||||0.021||||||Treatment comparisons between OMS302 and each of the other three groups were based on Wilcoxon rank-sum test. For subjects with mean count \> 30, the mean count was imputed as 45 for the purpose of treatment comparisons.|Wilcoxon rank-sum test|||||||0.021
72574170|NCT01193127|144674722|SUPERIORITY_OR_OTHER|||||||0.026||||||Treatment comparisons between OMS302 and each of the other three groups were based on Wilcoxon rank-sum test. For subjects with mean count \> 30, the mean count was imputed as 45 for the purpose of treatment comparisons.|Wilcoxon rank-sum test|||||||0.026
72574171|NCT01193127|144674723|SUPERIORITY_OR_OTHER|||||||0.822||||||Treatment comparisons between OMS302 and each of the other three groups were based on Wilcoxon rank-sum test. For subjects with mean count \> 30, the mean count was imputed as 45 for the purpose of treatment comparisons.|Wilcoxon rank-sum test|||||||0.822
72574172|NCT01193127|144674723|SUPERIORITY_OR_OTHER|||||||0.424||||||Treatment comparisons between OMS302 and each of the other three groups were based on Wilcoxon rank-sum test. For subjects with mean count \> 30, the mean count was imputed as 45 for the purpose of treatment comparisons.|Wilcoxon rank-sum test|||||||0.424
72574173|NCT01193127|144674723|SUPERIORITY_OR_OTHER|||||||0.695||||||Treatment comparisons between OMS302 and each of the other three groups were based on Wilcoxon rank-sum test. For subjects with mean count \> 30, the mean count was imputed as 45 for the purpose of treatment comparisons.|Wilcoxon rank-sum test|||||||0.695
72574174|NCT01193127|144674724|SUPERIORITY_OR_OTHER|||||||0.489||||||Treatment comparisons between OMS302 and each of the other three groups were based on Wilcoxon rank-sum test. For subjects with mean count \> 30, the mean count was imputed as 45 for the purpose of treatment comparisons.|Wilcoxon rank-sum test|||||||0.489
72574175|NCT01193127|144674724|SUPERIORITY_OR_OTHER|||||||0.459||||||Treatment comparisons between OMS302 and each of the other three groups were based on Wilcoxon rank-sum test. For subjects with mean count \> 30, the mean count was imputed as 45 for the purpose of treatment comparisons.|Wilcoxon rank-sum test|||||||0.459
72574176|NCT01193127|144674724|SUPERIORITY_OR_OTHER|||||||0.99||||||Treatment comparisons between OMS302 and each of the other three groups were based on Wilcoxon rank-sum test. For subjects with mean count \> 30, the mean count was imputed as 45 for the purpose of treatment comparisons.|Wilcoxon rank-sum test|||||||0.990
72574177|NCT01193127|144674726|SUPERIORITY_OR_OTHER|||||||0.4575||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.4575
72627109|NCT01405196|144783281|SUPERIORITY||LS mean difference|-0.09|||||TWO_SIDED|90.0|-3.09|2.92||||||MCS Week 8: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||2.92|-3.09|
72627110|NCT01405196|144783281|SUPERIORITY||LS mean difference|-0.02|||||TWO_SIDED|90.0|-3.03|2.99||||||MCS Week 12: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||2.99|-3.03|
72574178|NCT01193127|144674726|SUPERIORITY_OR_OTHER|||||||0.8318||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.8318
72574179|NCT01193127|144674726|SUPERIORITY_OR_OTHER|||||||0.8946||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.8946
72574180|NCT01193127|144674727|SUPERIORITY_OR_OTHER|||||||0.157||||||Ocular pain medications will be identified by reviewing concomitant medications. Subject incidence of ocular pain medication use at day 1 and post day 1 will be presented. Treatment comparisons will be performed using methodology 1.|Cochran-Mantel-Haenszel|||||||0.1570
72574181|NCT01193127|144674727|SUPERIORITY_OR_OTHER|||||||0.0839||||||Ocular pain medications will be identified by reviewing concomitant medications. Subject incidence of ocular pain medication use at day 1 and post day 1 will be presented. Treatment comparisons will be performed using methodology 1.|Cochran-Mantel-Haenszel|||||||0.0839
72574182|NCT01193127|144674727|SUPERIORITY_OR_OTHER|||||||0.092||||||Ocular pain medications will be identified by reviewing concomitant medications. Subject incidence of ocular pain medication use at day 1 and post day 1 will be presented. Treatment comparisons will be performed using methodology 1.|Cochran-Mantel-Haenszel|||||||0.0920
72574183|NCT01193127|144674728|SUPERIORITY_OR_OTHER|||||||0.711||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.711
72574184|NCT01193127|144674728|SUPERIORITY_OR_OTHER|||||||0.253||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.253
72627111|NCT01405196|144783281|SUPERIORITY||LS mean difference|-0.16|||||TWO_SIDED|90.0|-3.17|2.85||||||MCS Week 16: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||2.85|-3.17|
72627112|NCT01405196|144783281|SUPERIORITY||LS mean difference|-1.58|||||TWO_SIDED|90.0|-4.58|1.43||||||MCS Week 20: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||1.43|-4.58|
72627113|NCT01405196|144783281|SUPERIORITY||LS mean difference|-0.71|||||TWO_SIDED|90.0|-3.72|2.3||||||MCS Week 24: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||2.30|-3.72|
72574185|NCT01193127|144674728|SUPERIORITY_OR_OTHER|||||||0.104||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.104
72574186|NCT03246646|144674729|SUPERIORITY||Z test of proportions|0.66|||>|0.05|ONE_SIDED||||||Z test of independent proportions|||||||>.05
72574187|NCT02569112|144674730|SUPERIORITY|A significant improvement in skin laxity reduction is defined as a mean average increase in grade of 1 as per the GAIS.|||||<|0.01|||||||Wilcoxon (Mann-Whitney)|Used Wilcoxon Matched-Pairs Signed-Ranks test||The null hypothesis was that the addition of the multipolar radiofrequency with varipulse technology treatment to the cryolipolysis treatment would not show visual improvement.||||<0.01
72574188|NCT02352779|144674731|OTHER||Mean Difference (Final Values)|0.6763|STANDARD_ERROR_OF_MEAN|0.4843||0.1666|TWO_SIDED||||||ANCOVA|Based on a contrast using the three-arm ANCOVA.||BFI-SF||||0.1666
72574189|NCT02352779|144674731|OTHER||Mean Difference (Final Values)|0.6936|STANDARD_ERROR_OF_MEAN|0.4567||0.1329|TWO_SIDED||||||ANCOVA|Based on a contrast using the three-arm ANCOVA.||BFI-SF||||0.1329
72574190|NCT02352779|144674731|OTHER||Mean Difference (Final Values)|0.0831|STANDARD_ERROR_OF_MEAN|3.8065||0.9826|TWO_SIDED||||||ANCOVA|Based on a contrast using the three-arm ANCOVA.||MFSI-SF||||0.9826
72574191|NCT02352779|144674731|OTHER||Mean Difference (Final Values)|2.9898|STANDARD_ERROR_OF_MEAN|3.5448||0.4016|TWO_SIDED||||||ANCOVA|Based on a contrast using the three-arm ANCOVA.||MFSI-SF||||0.4016
72574192|NCT01398943|144674732|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
72574193|NCT01398943|144674732|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||||||>0.05
72574194|NCT01398943|144674733|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
72574195|NCT01398943|144674733|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||||||>0.05
72574196|NCT01565850|144674739|NON_INFERIORITY_OR_EQUIVALENCE|A total sample size of 150 HIV-1 infected participants, randomized in a 2:1 ratio to 2 groups, would achieve 56% power to evaluate noninferiority with respect to the response rate of HIV-1 RNA \< 50 copies/mL at Week 24 if a response rate of 0.88 for both arms, a noninferiority margin of 0.12, and the significance level of the test at a one-sided 0.025 level were assumed.|Difference in proportions|3.3||||0.64|TWO_SIDED|95.0|-11.4|18.1||The p-value for the superiority test comparing the percentages of virologic success was from the Cochran-Mantel-Haenszel test stratified by baseline HIV-1 RNA and race strata.|Cochran-Mantel-Haenszel||The difference in percentages of virologic success and its 95% confidence interval (CI) were calculated based on baseline HIV-1 RNA and race stratum-adjusted Mantel-Haenszel proportion.|The null hypothesis was that the D/C/F/TAF group is at least 12% worse than the DRV+COBI+FTC/TDF group with respect to the percentage of participants achieving HIV-1 RNA \< 50 copies/mL (response rate as defined by the snapshot analysis algorithm) at Week 24; the alternative hypothesis was that the response rate in the D/C/F/TAF group is less than 12% worse than that in the DRV+COBI +FTC/TDF group.||18.1|-11.4|0.64
72627114|NCT01405196|144783281|SUPERIORITY||LS mean difference|2.67|||||TWO_SIDED|90.0|0.14|5.2||||||PCS Week 4: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||5.20|0.14|
72627115|NCT01405196|144783281|SUPERIORITY||LS mean difference|3.36|||||TWO_SIDED|90.0|0.84|5.89||||||PCS Week 8: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||5.89|0.84|
72627116|NCT01405196|144783281|SUPERIORITY||LS mean difference|3.23|||||TWO_SIDED|90.0|0.7|5.76||||||PCS Week 12: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||5.76|0.70|
72627117|NCT01405196|144783281|SUPERIORITY||LS mean difference|3.77|||||TWO_SIDED|90.0|1.24|6.3||||||PCS Week 16: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||6.30|1.24|
72574197|NCT01565850|144674740|NON_INFERIORITY_OR_EQUIVALENCE|The null hypothesis was that the D/C/F/TAF group is at least 12% worse than the DRV+COBI+FTC/TDF group with respect to the percentage of participants achieving HIV-1 RNA \< 50 copies/mL (response rate as defined by the snapshot analysis algorithm) at Week 48; the alternative hypothesis was that the response rate in the D/C/F/TAF group is less than 12% worse than that in the DRV+COBI +FTC/TDF group.|Difference in proportions|-6.2||||0.35|TWO_SIDED|95.0|-19.9|7.4||The p-value for the superiority test comparing the percentages of virologic success was from the Cochran-Mantel-Haenszel test stratified by baseline HIV-1 RNA and race strata.|Cochran-Mantel-Haenszel||The difference in percentages of virologic success and its 95% CI were calculated based on baseline HIV-1 RNA and race stratum-adjusted Mantel-Haenszel proportion.|||7.4|-19.9|0.35
72574198|NCT01565850|144674741|SUPERIORITY_OR_OTHER||Difference in LSM|0.04||||0.67|TWO_SIDED|95.0|-0.14|0.21||The p-value, difference in least squares mean (LSM), and its 95% CI were from ANOVA model with baseline HIV-1 RNA level (≤ 100,000 or \> 100,000 copies/mL) and race (Black or non-Black) as fixed effects in the model.|ANOVA|||||0.21|-0.14|0.67
72627118|NCT01405196|144783281|SUPERIORITY||LS mean difference|3.1|||||TWO_SIDED|90.0|0.57|5.63||||||PCS Week 20: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||5.63|0.57|
72574199|NCT01565850|144674742|SUPERIORITY_OR_OTHER||Difference in LSM|0.06||||0.5|TWO_SIDED|95.0|-0.11|0.23||The p-value, difference in LSM, and its 95% CI were from ANOVA model with baseline HIV-1 RNA level (≤ 100,000 or \> 100,000 copies/mL) and race (Black or non-Black) as fixed effects in the model.|ANOVA|||||0.23|-0.11|0.50
72574200|NCT01565850|144674743|SUPERIORITY_OR_OTHER||Difference in LSM|45.0||||0.11|TWO_SIDED|95.0|-10.0|101.0||The p-value, difference in LSM, and its 95% CI were from ANOVA model with baseline HIV-1 RNA level (≤ 100,000 or \> 100,000 copies/mL) and race (Black or non-Black) as fixed effects in the model.|ANOVA|||||101|-10|0.11
72574201|NCT01565850|144674744|SUPERIORITY_OR_OTHER||Difference in LSM|18.0||||0.5|TWO_SIDED|95.0|-35.0|72.0||The p-value, difference in LSM, and its 95% CI were from ANOVA model with baseline HIV-1 RNA level (≤ 100,000 or \> 100,000 copies/mL) and race (Black or non-Black) as fixed effects in the model.|ANOVA|||||72|-35|0.50
72574202|NCT03611543|144674776|SUPERIORITY||||||<|0.0001||||||Information related to the INVESTIGATIONAL group.|Wilcoxon Rank-Sum test|||||||<0.0001
72627119|NCT01405196|144783281|SUPERIORITY||LS mean difference|3.03||||||90.0|0.5|5.56||||||PCS Week 24: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||5.56|0.50|
72627120|NCT01405196|144783281|SUPERIORITY||LS mean difference|1.96|||||TWO_SIDED|90.0|-0.53|4.46||||||PCS Week 4: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||4.46|-0.53|
72627121|NCT01405196|144783281|SUPERIORITY||LS mean difference|2.68||||||90.0|0.2|5.17||||||PCS Week 8: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||5.17|0.20|
72627122|NCT01405196|144783281|SUPERIORITY||LS mean difference|1.84|||||TWO_SIDED|90.0|-0.65|4.32||||||PCS Week 12: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||4.32|-0.65|
72409246|NCT01706250|144326882|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.0|STANDARD_DEVIATION|0.46||1||95.0|||||[Signed Rank]|||Change, in Itching for MAXCLARITY II Vs PROACTIV: from BL to Wk 1 (within group)||||1.0000
72574203|NCT00792935|144674859|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.9|STANDARD_ERROR_OF_MEAN|4.4||0.847|TWO_SIDED|95.0|-7.9|9.6|||Constrained longitudinal analysis|||Using a standard deviation of 23.5 mg/dL, a sample size of at least 65 participants per treatment group would be required to have an 80% power to detect a true difference of 12.5 mg/dL between MK-0941 and glimepiride as measured by change from baseline in 24-hour WMG at Week 6.||9.6|-7.9|0.847
72574204|NCT00792935|144674860|SUPERIORITY_OR_OTHER||Proportions|-7.7||||0.361|TWO_SIDED|95.0|-23.6|8.7|||Miettinen & Nurminen method.||The estimated value represents the difference in percentages, MK-0941 minus Glimepiride.|||8.7|-23.6|0.361
72574205|NCT04663295|144674861|SUPERIORITY||Mean Difference (Net)|5.6|||<|0.001|TWO_SIDED|95.0|3.3|7.9||One-sided test at significant level of 0.025.|Wilcoxon (Mann-Whitney)|Wilcoxon Signed rank test comparing baseline and study period.||||7.9|3.3|<0.001
72574206|NCT02684630|144674871|OTHER|A procedure is a success if the donor's post-procedure platelet count is ≥ 100,000 platelets/μL, lower one-sided 95% confidence interval for the procedure success rate is at least 95%.|Simple sample proportion|1.0|STANDARD_DEVIATION|0.0|||ONE_SIDED|95.0|0.951||||||Estimated proportion is 100%. Hence standard deviation is estimated as 0.|"Sample Size Determination:~Up to 160 participants were to be enrolled in this study to ensure 60 evaluable single platelet product collections and 60 evaluable double platelet product collections. This number was chosen to meet the FDA requirements of 95% of postprocedure participant platelet count of ≥ 100,000 platelets/μL with 95% confidence."|||0.951|
72627123|NCT01405196|144783281|SUPERIORITY||LS mean difference|2.01|||||TWO_SIDED|90.0|-0.47|4.5||||||PCS Week 16: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||4.50|-0.47|
72627124|NCT01405196|144783281|SUPERIORITY||LS mean difference|2.34|||||TWO_SIDED|90.0|-0.15|4.82||||||PCS Week 20: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||4.82|-0.15|
72627125|NCT01405196|144783281|SUPERIORITY||LS mean difference|2.59|||||TWO_SIDED|90.0|0.11|5.08||||||PCS Week 24: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||5.08|0.11|
72627126|NCT01405196|144783283|SUPERIORITY||LS mean difference|2.08|||||TWO_SIDED|90.0|-1.26|5.42||||||Week 4: Analysis was done using the ANCOVA model; CI parameter being the Least Square (LS) mean difference from that model.||5.42|-1.26|
72627127|NCT01405196|144783283|SUPERIORITY||LS mean difference|1.95|||||TWO_SIDED|90.0|-1.38|5.29||||||Week 8: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||5.29|-1.38|
72627128|NCT01405196|144783283|SUPERIORITY||LS mean difference|2.81|||||TWO_SIDED|90.0|-0.53|6.15||||||Week 12: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||6.15|-0.53|
72574207|NCT02684630|144674872|OTHER|A procedure is a success if the donor's post-procedure platelet count is ≥ 100,000 platelets/μL, lower one-sided 95% confidence interval for the procedure success rate is at least 95%.|Simple sample proportion|1.0|STANDARD_DEVIATION|0.0|||ONE_SIDED|95.0|0.951||||||Estimated proportion is 100%. Hence standard deviation is estimated as 0.|"Sample Size Determination:~Up to 160 participants were to be enrolled in this study to ensure 60 evaluable single platelet product collections and 60 evaluable double platelet product collections. This number was chosen to meet the FDA requirements of 95% of postprocedure participant platelet count of ≥ 100,000 platelets/μL with 95% confidence."|||0.951|
72574208|NCT00631657|144674873|SUPERIORITY_OR_OTHER||Difference in Least Squares (LS) Means|48.7|||<|0.0001|TWO_SIDED|95.0|35.0|62.5|||ANCOVA||ANCOVA performed with fixed effects for treatment and (pooled) center as factors and baseline TST as covariate.|||62.5|35.0|<0.0001
72574209|NCT00631657|144674876|SUPERIORITY_OR_OTHER||Difference in LS Means|-4.9||||0.2145|TWO_SIDED|95.0|-12.6|2.8|||ANCOVA||ANCOVA performed with fixed effects for treatment and (pooled) center as factors and baseline SL as covariate.|||2.8|-12.6|0.2145
72574210|NCT00631657|144674877|SUPERIORITY_OR_OTHER||Difference in LS Means|-25.0|||<|0.0001|TWO_SIDED|95.0|-34.5|-15.4|||ANCOVA||ANCOVA performed with fixed effects for treatment and (pooled) center as factors and baseline WASO as covariate.|||-15.4|-34.5|<0.0001
72574211|NCT00325195|144674902|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Fisher Exact|||||||<0.001
72574212|NCT00325195|144674902|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Fisher Exact|||||||<0.001
72574213|NCT00325195|144674903|SUPERIORITY_OR_OTHER||||||<|0.002||95.0|||||Fisher Exact|||||||<0.002
72574214|NCT00325195|144674903|SUPERIORITY_OR_OTHER|||||||0.2||95.0|||||Fisher Exact|||||||0.200
72627129|NCT01405196|144783283|SUPERIORITY||LS mean difference|3.88|||||TWO_SIDED|90.0|0.54|7.22||||||Week 16: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||7.22|0.54|
72409247|NCT01706250|144326882|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.32|STANDARD_DEVIATION|0.58||0.0625||95.0|||||Signed Rank|||Change, in Itching for MAXCLARITY II Vs PROACTIV: from BL to Wk 2 (within group)||||0.0625
72574215|NCT00325195|144674904|SUPERIORITY_OR_OTHER|||||||0.007||95.0|||||Fisher Exact|||% of pegloticase q2 participants reporting flares compared to placebo pts during Months 4-6 treatment period||||0.007
72574216|NCT00325195|144674904|SUPERIORITY_OR_OTHER|||||||0.321||95.0|||||Fisher Exact|||% of pegloticase q4 participants reporting flares compared to placebo pts during Months 4-6 treatment period||||0.321
72574217|NCT00325195|144674905|SUPERIORITY_OR_OTHER|||||||0.166||95.0|||||t-test, 2 sided|||||||0.166
72574218|NCT00325195|144674905|SUPERIORITY_OR_OTHER|||||||0.17||95.0|||||t-test, 2 sided|||||||0.170
72574219|NCT00325195|144674906|SUPERIORITY_OR_OTHER|||||||0.008||95.0|||||t-test, 2 sided|||||||0.008
72574220|NCT00325195|144674906|SUPERIORITY_OR_OTHER|||||||0.024||95.0|||||t-test, 2 sided|||||||0.024
72574221|NCT04715932|144674928|SUPERIORITY||Odds Ratio (OR)|1.49||||0.3849|TWO_SIDED|95.0|0.6|3.69|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression).||||3.69|0.60|0.3849
72574222|NCT04715932|144674929|SUPERIORITY||Odds Ratio (OR)|1.43||||0.3139|TWO_SIDED|95.0|0.71|2.88|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||2.88|0.71|0.3139
72574223|NCT04715932|144674930|SUPERIORITY||Odds Ratio (OR)|1.18||||0.5886|TWO_SIDED|95.0|0.65|2.14|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||2.14|0.65|0.5886
72574224|NCT04715932|144674931|SUPERIORITY||Odds Ratio (OR)|0.69||||0.2328|TWO_SIDED|95.0|0.38|1.27|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||1.27|0.38|0.2328
72574225|NCT04715932|144674932|SUPERIORITY||Rate Ratio|1.14||||0.156|TWO_SIDED|95.0|0.95|1.37|||Mixed Models Analysis|Generalized linear mixed model (repeated poisson regression).||||1.37|0.95|0.1560
72574226|NCT04715932|144674933|SUPERIORITY||Rate Ratio|1.06||||0.6233|TWO_SIDED|95.0|0.84|1.33|||Mixed Models Analysis|Generalized linear mixed model (repeated poisson regression)||||1.33|0.84|0.6233
72574227|NCT04715932|144674934|SUPERIORITY||Rate Ratio|1.03||||0.829|TWO_SIDED|95.0|0.78|1.37|||Mixed Models Analysis|Generalized linear mixed model (repeated poisson regression)||||1.37|0.78|0.8290
72574228|NCT04715932|144674935|SUPERIORITY||Rate Ratio|0.98||||0.9222|TWO_SIDED|95.0|0.69|1.4|||Mixed Models Analysis|Generalized linear mixed model (repeated poisson regression)||||1.40|0.69|0.9222
72574229|NCT04715932|144674936|SUPERIORITY|||||||0.8834|||||||Log Rank|||||||0.8834
72574230|NCT04715932|144674937|SUPERIORITY||Odds Ratio (OR)|1.02||||0.9416|TWO_SIDED|95.0|0.59|1.77|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||1.77|0.59|0.9416
72574231|NCT04715932|144674938|SUPERIORITY||Odds Ratio (OR)|0.87||||0.6296|TWO_SIDED|95.0|0.49|1.55|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||1.55|0.49|0.6296
72574232|NCT04715932|144674939|SUPERIORITY||Odds Ratio (OR)|0.75||||0.3711|TWO_SIDED|95.0|0.41|1.4|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||1.40|0.41|0.3711
72574233|NCT04715932|144674940|SUPERIORITY||Odds Ratio (OR)|0.82||||0.5696|TWO_SIDED|95.0|0.42|1.61|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||1.61|0.42|0.5696
72574234|NCT04715932|144674941|SUPERIORITY||Odds Ratio (OR)|0.83||||0.7583|TWO_SIDED|95.0|0.26|2.67|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||2.67|0.26|0.7583
72574235|NCT04715932|144674942|SUPERIORITY||Odds Ratio (OR)|0.84||||0.8091|TWO_SIDED|95.0|0.2|3.58|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||3.58|0.20|0.8091
72574236|NCT04715932|144674943|SUPERIORITY||Odds Ratio (OR)|1.67||||0.5591|TWO_SIDED|95.0|0.3|9.42|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||9.42|0.30|0.5591
72574237|NCT04715932|144674944|SUPERIORITY|||||||0.9983|||||||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||||0.9983
72574238|NCT04715932|144674945|SUPERIORITY||Odds Ratio (OR)|1.6||||0.1068|TWO_SIDED|95.0|0.9|2.82|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||2.82|0.90|0.1068
72574239|NCT04715932|144674946|SUPERIORITY||Odds Ratio (OR)|1.07||||0.8382|TWO_SIDED|95.0|0.57|1.98|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||1.98|0.57|0.8382
72627130|NCT01405196|144783283|SUPERIORITY||LS mean difference|1.95|||||TWO_SIDED|90.0|-1.39|5.29||||||Week 20: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||5.29|-1.39|
72574240|NCT04715932|144674947|SUPERIORITY||Odds Ratio (OR)|1.22||||0.5912|TWO_SIDED|95.0|0.59|2.51|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||2.51|0.59|0.5912
72627131|NCT01405196|144783283|SUPERIORITY||LS mean difference|1.69|||||TWO_SIDED|90.0|-1.65|5.03||||||Week 24: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||5.03|-1.65|
72627132|NCT01405196|144783283|SUPERIORITY||LS mean difference|1.69|||||TWO_SIDED|90.0|-1.61|4.99||||||Week 4: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||4.99|-1.61|
72627133|NCT01405196|144783283|SUPERIORITY||LS mean difference|0.97|||||TWO_SIDED|90.0|-2.31|4.26||||||Week 8: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||4.26|-2.31|
72627134|NCT01405196|144783283|SUPERIORITY||LS mean difference|1.33|||||TWO_SIDED|90.0|-1.96|4.61||||||Week 12: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||4.61|-1.96|
72627135|NCT01405196|144783283|SUPERIORITY||LS mean difference|3.6|||||TWO_SIDED|90.0|0.32|6.89||||||Week 16: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||6.89|0.32|
72627136|NCT01405196|144783283|SUPERIORITY||LS mean difference|0.91|||||TWO_SIDED|90.0|-2.38|4.19||||||Week 20: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||4.19|-2.38|
72627137|NCT01405196|144783283|SUPERIORITY||LS mean difference|0.6|||||TWO_SIDED|90.0|-2.68|3.88||||||Week 24: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||3.88|-2.68|
72627138|NCT01729039|144783287|SUPERIORITY|||||||0.356||||||Main effect of time (baseline to post-PT) alpha = .05|ANOVA|||||||.356
72627139|NCT01729039|144783287|SUPERIORITY|||||||0.84||||||Interaction of Time by Group (GS vs. CON) alpha = .05|ANOVA|||||||.840
72627140|NCT01729039|144783288|SUPERIORITY|||||||0.17||||||Main effect of Time (baseline to post-PT) Alpha=.05|ANOVA|||||||.170
72627141|NCT01729039|144783288|SUPERIORITY|||||||0.297||||||Interaction of Time by Group (GS vs. CON) alpha = .05|ANOVA|||||||.297
72627142|NCT01729039|144783289|SUPERIORITY||||||<|0.001|||||||ANOVA|Main effect of Time (baseline to post-PT) alpha = .05||||||<.001
72627143|NCT01729039|144783289|SUPERIORITY|||||||0.817||||||Interaction of Time by Group (GS vs. CON) alpha = .05|ANOVA|||||||.817
72627144|NCT01729039|144783290|SUPERIORITY|||||||0.005||||||Main effect of Time (baseline to post-PT) alpha = .05|ANOVA|||||||.005
72627145|NCT01729039|144783290|SUPERIORITY|||||||0.172||||||Interaction of Time by Group (GS vs. CON) alpha = .05|ANOVA|||||||.172
72409248|NCT01706250|144326882|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.28|STANDARD_DEVIATION|0.75||0.25||95.0|||||Signed Rank|||Change, in Itching for MAXCLARITY II Vs PROACTIV: from BL to Wk 4 (within group)||||0.2500
72574241|NCT04715932|144674949|SUPERIORITY||Odds Ratio (OR)|0.78||||0.3686|TWO_SIDED|95.0|0.45|1.35|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||1.35|0.45|0.3686
72574242|NCT04715932|144674950|SUPERIORITY||Odds Ratio (OR)|1.05||||0.8711|TWO_SIDED|95.0|0.59|1.86|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||1.86|0.59|0.8711
72627146|NCT01729039|144783291|SUPERIORITY|||||||0.009||||||Main effect of time (baseline to post-PT) alpha = .05|ANOVA|||||||.009
72627147|NCT01729039|144783291|SUPERIORITY|||||||0.146||||||Interaction of Time by Grou (GS vs. CON) alpha = .05|ANOVA|||||||.146
72627148|NCT00829998|144783300|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of Geometric Means|97.4||||||90.0|89.4|106.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||106|89.4|
72627149|NCT00829998|144783301|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of Geometric Means|102.0||||||90.0|97.1|107.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||107|97.1|
72627150|NCT00829998|144783302|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of Geometric Means|102.0||||||90.0|97.1|107.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||107|97.1|
72627151|NCT00834197|144783303|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|100.59||||||90.0|95.76|105.65|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||105.65|95.76|
72627152|NCT00834197|144783304|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|98.17||||||90.0|94.82|101.65|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||101.65|94.82|
72627153|NCT00834197|144783305|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|98.25||||||90.0|95.22|101.39|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||101.39|95.22|
72627154|NCT01585025|144783316|SUPERIORITY|||||||0.007|||||||Wilcoxon (Mann-Whitney)|||Paired comparison of fasting FGF19 at baseline on day 0 and on day 14 of OCA treatment||||0.007
72627155|NCT01585025|144783316|SUPERIORITY|||||||0.11|||||||Wilcoxon (Mann-Whitney)|||Paired comparison of fasting FGF19 at baseline on day 0 and on day 14 of OCA treatment||||0.11
72627156|NCT01585025|144783316|SUPERIORITY|||||||0.12|||||||Wilcoxon (Mann-Whitney)|||Paired comparison of fasting FGF19 at baseline on day 0 and on day 14 of OCA treatment||||0.12
72627157|NCT01585025|144783317|SUPERIORITY|||||||0.72|||||||Wilcoxon (Mann-Whitney)|||Change in FGF19 AUC||||0.72
72627158|NCT01585025|144783317|SUPERIORITY|||||||0.51|||||||Wilcoxon (Mann-Whitney)|||Change in FGF19 AUC||||0.51
72627159|NCT01585025|144783317|SUPERIORITY|||||||0.13|||||||Wilcoxon (Mann-Whitney)|||Change in FGF19 AUC||||0.13
72627160|NCT01585025|144783318|SUPERIORITY|||||||0.03|||||||Wilcoxon (Mann-Whitney)|||Change in fasting C4||||0.03
72538055|NCT03692078|144605800|EQUIVALENCE|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 5. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|6.883|||<|0.0001|TWO_SIDED|95.0|6.773|6.994|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 5. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 5. (mITT Population)||6.994|6.773|<.0001
72538056|NCT03692078|144605800|EQUIVALENCE|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 7. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|6.892|||<|0.0001|TWO_SIDED|95.0|6.78|7.004|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 7. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 7. (mITT Population)||7.004|6.780|<.0001
72538057|NCT03692078|144605800|EQUIVALENCE|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 5. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|6.942|||<|0.0001|TWO_SIDED|95.0|6.829|7.054|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 5. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 5. (mITT Population)||7.054|6.829|<.0001
72538058|NCT03692078|144605800|EQUIVALENCE|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 7. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|6.896|||<|0.0001|TWO_SIDED|95.0|6.784|7.008|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 7. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 7. (mITT Population)||7.008|6.784|<.0001
72538059|NCT03692078|144605800|EQUIVALENCE|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 5. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|5.879|||<|0.0001|TWO_SIDED|95.0|5.739|6.019|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 5. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 5. (mITT Population)||6.019|5.739|<.0001
72538060|NCT03692078|144605800|EQUIVALENCE|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 7. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|5.804|||<|0.0001|TWO_SIDED|95.0|5.662|5.946|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 7. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 7. (mITT Population)||5.946|5.662|<.0001
72538061|NCT03692078|144605800|EQUIVALENCE|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 5. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|5.916|||<|0.0001|TWO_SIDED|95.0|5.778|6.054|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 5. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 5. (mITT Population)||6.054|5.778|<.0001
72538062|NCT03692078|144605800|EQUIVALENCE|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 7. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|5.917|||<|0.0001|TWO_SIDED|95.0|5.775|6.058|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 7. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 7. (mITT Population)||6.058|5.775|<.0001
72538063|NCT03692078|144605800|EQUIVALENCE|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 5. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|6.017|||<|0.0001|TWO_SIDED|95.0|5.881|6.153|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 5. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 5. (mITT Population)||6.153|5.881|<.0001
72627161|NCT01585025|144783318|SUPERIORITY|||||||0.11|||||||Wilcoxon (Mann-Whitney)|||Change in fasting C4||||0.11
72627162|NCT01585025|144783318|SUPERIORITY|||||||0.02|||||||Wilcoxon (Mann-Whitney)|||Change in fasting C4||||0.02
72627163|NCT01585025|144783319|SUPERIORITY|||||||0.02|||||||Wilcoxon (Mann-Whitney)|||Change in bile acid 6h AUC||||0.02
72627164|NCT01585025|144783319|SUPERIORITY|||||||0.04|||||||Wilcoxon (Mann-Whitney)|||Change in bile acid 6h AUC||||0.04
72627165|NCT01585025|144783319|SUPERIORITY|||||||0.02|||||||Wilcoxon (Mann-Whitney)|||Change in bile acid 6h AUC||||0.02
72627166|NCT01585025|144783320|SUPERIORITY|||||||0.03|||||||Wilcoxon (Mann-Whitney)|||Comparison of change in number of stools per week||||0.03
72538064|NCT03692078|144605800|EQUIVALENCE|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 7. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|6.012|||<|0.0001|TWO_SIDED|95.0|5.874|6.149|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 7. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 7. (mITT Population)||6.149|5.874|<.0001
72538065|NCT03692078|144605800|EQUIVALENCE|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 5. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-0.484|||<|0.0001|TWO_SIDED|95.0|-0.711|-0.257|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 5. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 5. (mITT Population)||-0.257|-0.711|<.0001
72538066|NCT03692078|144605800|EQUIVALENCE|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 7. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-0.476|||<|0.0001|TWO_SIDED|95.0|-0.705|-0.248|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 7. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 7. (mITT Population)||-0.248|-0.705|<.0001
72538067|NCT03692078|144605800|EQUIVALENCE|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 5. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-0.426|||<|0.0001|TWO_SIDED|95.0|-0.654|-0.198|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 5. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 5. (mITT Population)||-0.198|-0.654|<.0001
72538068|NCT03692078|144605800|EQUIVALENCE|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 7. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-0.472|||<|0.0001|TWO_SIDED|95.0|-0.701|-0.244|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 7. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 7. (mITT Population)||-0.244|-0.701|<.0001
72538069|NCT03692078|144605800|EQUIVALENCE|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 5. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-1.489|||<|0.0001|TWO_SIDED|95.0|-1.747|-1.23|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 5. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 5. (mITT Population)||-1.230|-1.747|<.0001
72627167|NCT01585025|144783320|SUPERIORITY|||||||0.17|||||||Wilcoxon (Mann-Whitney)|||Comparison of change in number of stools per week||||0.17
72627168|NCT01585025|144783320|SUPERIORITY|||||||0.31|||||||Wilcoxon (Mann-Whitney)|||Comparison of change in number of stools per week||||0.31
72627169|NCT01585025|144783321|SUPERIORITY|||||||0.05|||||||Wilcoxon (Mann-Whitney)|||Change in median stool form||||0.05
72627170|NCT01585025|144783321|SUPERIORITY|||||||0.04|||||||Wilcoxon (Mann-Whitney)|||Change in median stool form||||0.04
72627171|NCT01585025|144783321|SUPERIORITY|||||||0.74|||||||Wilcoxon (Mann-Whitney)|||Change in median stool form||||0.74
72627172|NCT01585025|144783322|SUPERIORITY|||||||0.005|||||||Wilcoxon (Mann-Whitney)|||Paired difference in weekly index score||||0.005
72627173|NCT01585025|144783322|SUPERIORITY|||||||0.03|||||||Wilcoxon (Mann-Whitney)|||Paired difference in weekly index score||||0.03
72627174|NCT01585025|144783322|SUPERIORITY|||||||0.61|||||||Wilcoxon (Mann-Whitney)|||Paired difference in weekly index score||||0.61
72627175|NCT01246960|144783331|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.98||||0.886|TWO_SIDED|95.0|0.69|1.37|||Stratified Log Rank|||||1.37|0.69|0.886
72627176|NCT01246960|144783332|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.08||||0.712|TWO_SIDED|95.0|0.73|1.58|||Stratified Log Rank|||||1.58|0.73|0.712
72627177|NCT01246960|144783335|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.88||||0.516|TWO_SIDED|95.0|0.59|1.3|||Stratified Log Rank|||||1.30|0.59|0.516
72627178|NCT03376516|144783392|OTHER|||||||0.9593||||||P-Value for patients aged 1-\<6 years (N=5)|ANOVA|||||||0.9593
72627179|NCT03376516|144783392|OTHER|||||||0.3752||||||P-Value for patients aged 6-\<12 years (N=5)|ANOVA|||||||0.3752
72627180|NCT03376516|144783392|OTHER|||||||0.8273||||||P-Value for total PK population (N=10)|ANOVA|||||||0.8273
72409249|NCT01706250|144326882|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.17|STANDARD_DEVIATION|0.38||0.25||95.0|||||Signed Rank|||Change, in Itching for MAXCLARITY II Vs PROACTIV: from BL to Wk 8 (within group)||||0.2500
72574243|NCT04715932|144674951|SUPERIORITY||Odds Ratio (OR)|1.03||||0.9124|TWO_SIDED|95.0|0.57|1.87|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||1.87|0.57|0.9124
72627181|NCT03376516|144783393|OTHER|P-Value for patients aged 1-\<6 years (N=5)||||||0.8536|||||||ANOVA|||||||0.8536
72627182|NCT03376516|144783393|OTHER|||||||0.9791||||||P-Value for patients aged 6-\<12 years (N=5)|ANOVA|||||||0.9791
72409250|NCT01706250|144326883|SUPERIORITY_OR_OTHER||Signed Rank|0.15|STANDARD_DEVIATION|0.59||0.5||95.0|||||Signed Rank|||Change, in Scaling for MAXCLARITY II Vs PROACTIV: from BL to Wk 1 (within group)||||0.5000
72409251|NCT01706250|144326883|SUPERIORITY_OR_OTHER||Signed Rank|0.11|STANDARD_DEVIATION|0.57||0.75||95.0|||||Signed Rank|||Change, in Scaling for MAXCLARITY II Vs PROACTIV: from BL to Wk 2 (within group)||||0.7500
72627183|NCT03376516|144783393|OTHER|||||||0.9791||||||P-Value for total PK population (N=10)|ANOVA|||||||0.9791
72627184|NCT03376516|144783395|OTHER||Pearson-Copper|0.0|||||TWO_SIDED|95.0|0.0|30.85||||||||30.85|0|
72627185|NCT00582907|144783401|SUPERIORITY_OR_OTHER||Risk Ratio, log|-1.7|STANDARD_DEVIATION|0.78||0.027|TWO_SIDED|95.0|-3.4|-0.1|||Signed rank|||Based upon FMF colchicine controlled studies showing an \~80% decrease in attacks, we estimated, based on baseline attacks every 4 weeks, there would be a difference of 0.5 attacks per month between rilonacept and placebo. With a two-sided 5% significance level and power of 80% we aimed for 14 evaluable participants who completed at least 2 treatment courses. The null hypothesis is that there would be no significant differences in the number of attacks between use of rilonacept and placebo.||-0.1|-3.4|0.027
72627186|NCT00582907|144783401|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.59|STANDARD_DEVIATION|0.12||||95.0|0.39|0.85|||Bayesian modeling||Attacks while receiving rilonacept is the numerator and attacks while receiving placebo is the denominator. In Bayesian statistics credible interval equals confidence interval.|This analysis was done by Bayesian Statistics using a non-informative (neutral) prior (log normal distribution mean 9 \[SD 10\]). The null hypothesis was that the rilonacept/placebo FMF odds ratio of attacks was 1.||0.85|0.39|
72627187|NCT00582907|144783402|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.0|STANDARD_DEVIATION|1.26||0.047|TWO_SIDED|95.0|-4.0|0.0|||Signed rank|||Null hypothesis: There were no significant differences between rilonacept and placebo in the occurence of injection site reactions. No power calculations for this outcome.||0|-4|0.047
72627188|NCT00582907|144783402|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.0||||0.13|TWO_SIDED|95.0|-0.56|0.17|||Signed rank|||Null hypothesis: There were no significant differences between rilonacept and placebo in the occurence of infections. No power calculations for this outcome.||0.17|-0.56|0.13
72627189|NCT00582907|144783403|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.2|STANDARD_DEVIATION|0.5||0.32||95.0|-2.4|0.5|||Signed rank|||Null hypothesis: There were no significant differences in the length of attacks during rilonacept vs. placebo treatment courses. Since this was a secondary outcome there were no power calculations performed.||0.5|-2.4|0.32
72627190|NCT00582907|144783404|SUPERIORITY_OR_OTHER||Differences in percent of courses|29.0||||0.004||95.0|||||McNemar|||Null hypothesis: There are no significant differences in the number of treatment courses without attacks between rilonacept and placebo. As a secondary measure there were no power calculations.||||0.004
72409252|NCT01706250|144326883|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.17|STANDARD_DEVIATION|0.62||0.4531||95.0|||||Signed Rank|||Change, in Scaling for MAXCLARITY II Vs PROACTIV: from BL to Wk 4 (within group)||||0.4531
72409253|NCT01706250|144326883|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.17|STANDARD_DEVIATION|0.86||0.625||95.0|||||Signed Rank|||Change, in Scaling for MAXCLARITY II Vs PROACTIV: from BL to Wk 8 (within group)||||0.6250
72409254|NCT03181542|144326902|SUPERIORITY|||||||0.34|||||||Fisher Exact|||||||0.34
72409255|NCT03181542|144326903|SUPERIORITY|||||||0.4|||||||Jonckheere-Terpstra Test|||||||0.40
72409256|NCT03181542|144326904|SUPERIORITY|||||||0.9|||||||Jonckheere-Terpstra Test|||||||0.90
72409257|NCT00958880|144326908|SUPERIORITY_OR_OTHER||Slope|10.46||||0.015||95.0|||||Regression, Linear|||||||.015
72409258|NCT00958880|144326909|SUPERIORITY_OR_OTHER||Slope|0.03||||0.575||95.0|||||Regression, Linear|||||||.575
72409259|NCT00853658|144326979|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.93||||0.1724|TWO_SIDED|95.0|0.85|1.03|||Regression, Cox|||(superiority)||1.03|0.85|0.1724
72409260|NCT00853658|144326979|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.96||||0.4579|TWO_SIDED|95.0|0.85|1.07|||Regression, Cox|||(superiority) Non-Diabetic patients||1.07|0.85|0.4579
72409261|NCT00853658|144326979|NON_INFERIORITY_OR_EQUIVALENCE|Pre-specified Non-inferiority margin 1.104 is used.|Hazard Ratio (HR)|0.99||||0.0368|TWO_SIDED|95.0|0.9|1.1|||Regression, Cox|||||1.10|0.90|0.0368
72409262|NCT00853658|144326979|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.99||||0.9118|TWO_SIDED|95.0|0.9|1.1|||Regression, Cox|||(superiority)||1.10|0.90|0.9118
72574244|NCT04715932|144674952|SUPERIORITY||Odds Ratio (OR)|0.7||||0.2952|TWO_SIDED|95.0|0.36|1.37|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||1.37|0.36|0.2952
72574245|NCT04715932|144674953|SUPERIORITY||Odds Ratio (OR)|1.2||||0.5894|TWO_SIDED|95.0|0.62|2.34|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||2.34|0.62|0.5894
72574246|NCT04715932|144674954|SUPERIORITY||Odds Ratio (OR)|1.14||||0.7887|TWO_SIDED|95.0|0.45|2.89|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||2.89|0.45|0.7887
72574247|NCT04715932|144674955|SUPERIORITY||Odds Ratio (OR)|0.73||||0.6348|TWO_SIDED|95.0|0.2|2.7|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||2.70|0.20|0.6348
72574248|NCT04715932|144674956|SUPERIORITY||Odds Ratio (OR)|0.39||||0.4257|TWO_SIDED|95.0|0.04|3.92|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||3.92|0.04|0.4257
72409263|NCT01312766|144326990|NON_INFERIORITY_OR_EQUIVALENCE|The one-way Analysis of Variance with Least-Squares means was performed to calculate the 95% Confidence Interval of the difference between the two treatments. If the lower bound of the 95% Confidence Interval of the difference between means (hMG-IBSA minus Menopur®) was greater than -2.1, then hMG-IBSA would be considered to be not-inferior to the comparator.|Mean Difference (Final Values)|1.9||||0.012|TWO_SIDED|95.0|0.43|3.43|||ANOVA|||||3.43|0.43|0.012
72538070|NCT03692078|144605800|EQUIVALENCE|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 7. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Final Values)|-1.564|||<|0.0001|TWO_SIDED|95.0|-1.825|-1.304|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 7. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 7. (mITT Population)||-1.304|-1.825|<.0001
72538071|NCT03692078|144605800|EQUIVALENCE|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 5. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-1.451|||<|0.0001|TWO_SIDED|95.0|-1.706|-1.197|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 5. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 5. (mITT Population)||-1.197|-1.706|<.0001
72574249|NCT04715932|144674957|SUPERIORITY||Odds Ratio (OR)|1.66||||0.1113|TWO_SIDED|95.0|0.89|3.11|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||3.11|0.89|0.1113
72574250|NCT04715932|144674958|SUPERIORITY||Odds Ratio (OR)|1.57||||0.2613|TWO_SIDED|95.0|0.71|3.47|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||3.47|0.71|0.2613
72574251|NCT04715932|144674959|SUPERIORITY||Odds Ratio (OR)|0.82||||0.7273|TWO_SIDED|95.0|0.27|2.49|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||2.49|0.27|0.7273
72574252|NCT04715932|144674960|SUPERIORITY||Odds Ratio (OR)|0.9||||0.8909|TWO_SIDED|95.0|0.19|4.19|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||4.19|0.19|0.8909
72574253|NCT04715932|144674961|SUPERIORITY||Odds Ratio (OR)|1.52||||0.1438|TWO_SIDED|95.0|0.87|2.67|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||2.67|0.87|0.1438
72574254|NCT04715932|144674962|SUPERIORITY||Odds Ratio (OR)|1.38||||0.344|TWO_SIDED|95.0|0.71|2.68|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||2.68|0.71|0.3440
72574255|NCT04715932|144674963|SUPERIORITY||Odds Ratio (OR)|1.22||||0.5968|TWO_SIDED|95.0|0.58|2.56|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||2.56|0.58|0.5968
72574256|NCT04715932|144674964|SUPERIORITY||Odds Ratio (OR)|1.52||||0.362|TWO_SIDED|95.0|0.62|3.76|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||3.76|0.62|0.3620
72409264|NCT01312766|144326991|SUPERIORITY_OR_OTHER|||||||0.25|TWO_SIDED||||||ANOVA|||||||0.25
72409265|NCT01312766|144326993|SUPERIORITY_OR_OTHER|||||||0.9|TWO_SIDED||||||Fisher Exact|||||||0.90
72409266|NCT01312766|144326994|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED||||||ANOVA|||||||0.02
72409267|NCT01312766|144326997|SUPERIORITY_OR_OTHER|||||||0.61|TWO_SIDED||||||Fisher Exact|||||||0.61
72409268|NCT01312766|144326998|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED||||||ANOVA|||||||0.002
72574257|NCT04715932|144674965|SUPERIORITY||Odds Ratio (OR)|1.97||||0.0875|TWO_SIDED|95.0|0.91|4.27|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||4.27|0.91|0.0875
72574258|NCT04715932|144674966|SUPERIORITY||Odds Ratio (OR)|0.91||||0.8397|TWO_SIDED|95.0|0.36|2.32|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||2.32|0.36|0.8397
72574259|NCT04715932|144674967|SUPERIORITY||Odds Ratio (OR)|1.36||||0.6265|TWO_SIDED|95.0|0.4|4.65|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||4.65|0.40|0.6265
72574260|NCT04715932|144674968|SUPERIORITY||Odds Ratio (OR)|1.21||||0.8528|TWO_SIDED|95.0|0.16|8.91|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||8.91|0.16|0.8528
72574261|NCT04715932|144674969|SUPERIORITY||Odds Ratio (OR)|1.34||||0.2983|TWO_SIDED|95.0|0.77|2.35|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||2.35|0.77|0.2983
72574262|NCT04715932|144674970|SUPERIORITY||Odds Ratio (OR)|1.19||||0.5611|TWO_SIDED|95.0|0.66|2.16|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||2.16|0.66|0.5611
72574263|NCT04715932|144674971|SUPERIORITY||Odds Ratio (OR)|1.29||||0.4643|TWO_SIDED|95.0|0.65|2.58|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||2.58|0.65|0.4643
72574264|NCT04715932|144674972|SUPERIORITY||Odds Ratio (OR)|1.38||||0.5063|TWO_SIDED|95.0|0.53|3.62|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||3.62|0.53|0.5063
72574265|NCT04715932|144674973|SUPERIORITY||Odds Ratio (OR)|1.41||||0.2292|TWO_SIDED|95.0|0.8|2.47|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||2.47|0.80|0.2292
72574266|NCT04715932|144674974|SUPERIORITY||Odds Ratio (OR)|1.16||||0.6097|TWO_SIDED|95.0|0.65|2.07|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||2.07|0.65|0.6097
72574267|NCT04715932|144674975|SUPERIORITY||Odds Ratio (OR)|1.07||||0.8389|TWO_SIDED|95.0|0.54|2.16|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||2.16|0.54|0.8389
72574268|NCT04715932|144674976|SUPERIORITY||Odds Ratio (OR)|0.99||||0.9764|TWO_SIDED|95.0|0.45|2.17|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||2.17|0.45|0.9764
72627191|NCT00582907|144783405|SUPERIORITY_OR_OTHER||Difference in percent of courses|40.0||||0.006||95.0|||||McNemar|||Null hypothesis: There are no significant differences in the number of treatment courses attaining at least a 50% decrease in attacks when compared to baseline between rilonacept and placebo courses.Since this was a secondary measure there were no power calculations.||||0.006
72538072|NCT03692078|144605800|EQUIVALENCE|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 7. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-1.452|||<|0.0001|TWO_SIDED|95.0|-1.71|-1.193|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 7. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 7. (mITT Population)||-1.193|-1.710|<.0001
72538073|NCT03692078|144605800|EQUIVALENCE|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 5. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|0.866|||<|0.0001|TWO_SIDED|95.0|0.622|1.11|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 5. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 5. (mITT Population)||1.110|0.622|<.0001
72574269|NCT04715932|144674977|SUPERIORITY||Odds Ratio (OR)|0.8||||0.4403|TWO_SIDED|95.0|0.46|1.4|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||1.40|0.46|0.4403
72574270|NCT04715932|144674978|SUPERIORITY||Odds Ratio (OR)|0.79||||0.5112|TWO_SIDED|95.0|0.39|1.6|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||1.60|0.39|0.5112
72627192|NCT00582907|144783406|SUPERIORITY_OR_OTHER||Log Rank|0.009||||0.009||95.0|||||Kaplan-Meier survival analysis|||Null hypothesis: There were no significant differences between rilonacept and placebo in the number of days from the start of the treatment course until the development of the a second attack.||||0.009
72627193|NCT00582907|144783407|SUPERIORITY_OR_OTHER||Median Difference (Net)|6.5||||0.156|TWO_SIDED|95.0|-0.5|12.5|||Signed Rank|||Null hypothesis: There are no significant differences in the erythrocyte sedimentation rate between rilonacept and placebo. As a secondary measure there were no power calculations.||12.5|-0.5|0.156
72538074|NCT03692078|144605800|EQUIVALENCE|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 7. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|0.88|||<|0.0001|TWO_SIDED|95.0|0.633|1.128|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 7. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 7. (mITT Population)||1.128|0.633|<.0001
72574271|NCT04715932|144674979|SUPERIORITY||Odds Ratio (OR)|1.04||||0.9306|TWO_SIDED|95.0|0.46|2.36|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||2.36|0.46|0.9306
72574272|NCT04715932|144674980|SUPERIORITY||Odds Ratio (OR)|0.73||||0.6046|TWO_SIDED|95.0|0.23|2.36|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||2.36|0.23|0.6046
72574273|NCT04715932|144674981|SUPERIORITY||Odds Ratio (OR)|1.15||||0.6963|TWO_SIDED|95.0|0.57|2.34|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||2.34|0.57|0.6963
72574274|NCT04715932|144674982|SUPERIORITY||Odds Ratio (OR)|0.65||||0.425|TWO_SIDED|95.0|0.22|1.88|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||1.88|0.22|0.4250
72574275|NCT04715932|144674983|SUPERIORITY||Odds Ratio (OR)|1.12||||0.8797|TWO_SIDED|95.0|0.27|4.65|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||4.65|0.27|0.8797
72574276|NCT04715932|144674984|SUPERIORITY||Odds Ratio (OR)|3.71||||0.2634|TWO_SIDED|95.0|0.37|37.03|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||37.03|0.37|0.2634
72574277|NCT04715932|144674985|SUPERIORITY||Odds Ratio (OR)|1.5||||0.271|TWO_SIDED|95.0|0.73|3.06|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||3.06|0.73|0.2710
72627194|NCT00582907|144783408|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.04||||0.22|TWO_SIDED|95.0|-0.03|0.29|||Signed Rank|||Null hypothesis: There are no differences in the C-reactive protein levels between the treatment courses. Since this was a secondary outcome measure no power calculations were performed.||0.29|-0.03|0.22
72409269|NCT01312766|144326999|SUPERIORITY_OR_OTHER|||||||0.004|TWO_SIDED||||||ANOVA|||||||0.004
72627195|NCT00582907|144783409|SUPERIORITY_OR_OTHER||Median Difference (Net)|29.4||||0.078|TWO_SIDED|95.0|0.4|78.1|||Signed Rank|||Null hypothesis: There were no differences between the platelet count between the rilonacept and placebo courses. Since this was a secondary outcome no power calculations were performed.||78.1|0.4|0.078
72627196|NCT00582907|144783410|SUPERIORITY_OR_OTHER||Median Difference (Net)|108.0||||0.063|TWO_SIDED|95.0|6.5|139.5|||Signed Rank|||Null hypothesis: There are no differences between the treatment arms in the fibrinogen level. Since this was a secondary outcome no power calculations were performed.||139.5|6.5|0.063
72627197|NCT00582907|144783411|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.0||||0.5|TWO_SIDED|95.0|-4.0|0.0|||Signed Rank|||Null hypothesis: There are no differences between the treatment arms in the serum amyloid A levels. Since this was a secondary outcome no power calculations were performed.||0|-4|0.50
72627198|NCT00582907|144783412|SUPERIORITY_OR_OTHER||Median Difference (Net)|-6.5||||0.021|TWO_SIDED|95.0|-11.1|-2.3|||Signed rank|||Null hypothesis: There are no significant differences in the physical health-related quality of life between rilonacept and placebo. As a secondary measure there were no power calculations.||-2.3|-11.1|0.021
72627199|NCT00582907|144783412|SUPERIORITY_OR_OTHER||Median Difference (Net)|-4.2||||0.42|TWO_SIDED|95.0|-6.8|3.9|||Signed Rank|||||3.9|-6.8|0.42
72627200|NCT00582907|144783413|SUPERIORITY_OR_OTHER||Median Difference (Net)|2.5||||0.136|TWO_SIDED|95.0|-2.3|9.8|||Signed rank|||Null hypothesis: There are no significant differences in the FMF Armenian Evaluation (severity) Score between rilonacept and placebo. As a secondary measure there were no power calculations.||9.8|-2.3|0.136
72627201|NCT00582907|144783414|SUPERIORITY_OR_OTHER||Median Difference (Net)|-5.0||||0.089|TWO_SIDED|95.0|-15.0|-1.0|||Signed rank|||Null hypothesis: There are no significant differences in the proportion of time participants were treated with rilonacept and placebo. As a secondary measure there were no power calculations.||-1|-15|0.089
72538075|NCT03692078|144605800|EQUIVALENCE|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 5. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|0.924|||<|0.0001|TWO_SIDED|95.0|0.68|1.169|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 5. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 5. (mITT Population)||1.169|0.680|<.0001
72538076|NCT03692078|144605800|EQUIVALENCE|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 7. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|0.884|||<|0.0001|TWO_SIDED|95.0|0.638|1.131|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 7. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 7. (mITT Population)||1.131|0.638|<.0001
72574278|NCT04715932|144674986|SUPERIORITY||Odds Ratio (OR)|1.82||||0.1748|TWO_SIDED|95.0|0.77|4.3|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||4.30|0.77|0.1748
72574279|NCT04715932|144674987|SUPERIORITY||Odds Ratio (OR)|1.12||||0.8513|TWO_SIDED|95.0|0.34|3.63|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||3.63|0.34|0.8513
72574280|NCT04715932|144674988|SUPERIORITY||Odds Ratio (OR)|1.21||||0.7906|TWO_SIDED|95.0|0.29|5.07|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||5.07|0.29|0.7906
72574281|NCT02740699|144675038|SUPERIORITY|||||||0.0256|||||||Wilcoxon Signed Rank Tests|||||||0.0256
72574282|NCT02740699|144675039|SUPERIORITY|||||||0.0254|||||||Wilcoxon Signed Rank Tests|||||||0.0254
72574283|NCT02740699|144675040|SUPERIORITY|||||||0.58|||||||Regression, Linear|||||||0.58
72627202|NCT00370292|144783415|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for 1 Hour Post-Dose (1 hour across cycles compared with pre-dose across cycles).|Repeated Measures Analysis of Variance|||||||<0.001
72627203|NCT00370292|144783415|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for 2 Hours Post-Dose (2 hours across cycles compared with pre-dose across cycles).|Repeated Measures Analysis of Variance|||||||<0.001
72627204|NCT00370292|144783415|SUPERIORITY_OR_OTHER|||||||0.03||95.0||||P-value for 4 Hours Post-Dose (4 hours across cycles compared with pre-dose across cycles).|Repeated Measures Analysis of Variance|||||||0.030
72627205|NCT00370292|144783415|SUPERIORITY_OR_OTHER|||||||0.166||95.0||||P-value for 6 Hours Post-Dose (6 hours across cycles compared with pre-dose across cycles).|Repeated Measures Analysis of Variance|||||||0.166
72627206|NCT00370292|144783415|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for 24 Hours Post-Dose (24 hours across cycles compared with pre-dose across cycles).|Repeated Measures Analysis of Variance|||||||<0.001
72627207|NCT00370292|144783415|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for 48 Hours Post-Dose (48 hours across cycles compared with pre-dose across cycles).|Repeated Measures Analysis of Variance|||||||<0.001
72627208|NCT00370292|144783417|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for 1 Hour Post-Dose (1 hour across cycles compared with pre-dose across cycles).|Repeated Measures Analysis of Variance|||||||<0.001
72409270|NCT01312766|144327000|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANOVA|||||||<0.001
72409271|NCT01312766|144327001|SUPERIORITY_OR_OTHER|||||||0.04|TWO_SIDED||||||ANOVA|||||||0.04
72627209|NCT00370292|144783417|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for 2 Hours Post-Dose (2 hours across cycles compared with pre-dose across cycles).|Repeated Measures Analysis of Variance|||||||<0.001
72627210|NCT00370292|144783417|SUPERIORITY_OR_OTHER|||||||0.333||95.0||||P-value for 4 Hours Post-Dose (4 hours across cycles compared with pre-dose across cycles).|Repeated Measures Analysis of Variance|||||||0.333
72627211|NCT00370292|144783417|SUPERIORITY_OR_OTHER|||||||0.849||95.0||||P-value for 6 Hours Post-Dose (6 hours across cycles compared with pre-dose across cycles).|Repeated Measures Analysis of Variance|||||||0.849
72409272|NCT01312766|144327002|SUPERIORITY_OR_OTHER|||||||0.61|TWO_SIDED||||||Fisher Exact|||||||0.61
72409273|NCT02556710|144327020|SUPERIORITY|||||||0.94|||||||ANCOVA|Adjusted for baseline WOMAC Score||||||0.94
72409274|NCT02556710|144327021|SUPERIORITY|||||||0.53|||||||ANCOVA|Adjusted for baseline WOMAC score||||||0.53
72538077|NCT03692078|144605800|EQUIVALENCE|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 5. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|-0.138||||0.68|TWO_SIDED|95.0|-0.411|0.134|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 5. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 5. (mITT Population)||0.134|-0.411|0.6800
72574284|NCT02740699|144675041|SUPERIORITY|||||||0.06|||||||Regression, Linear|||||||0.06
72574285|NCT02740699|144675042|SUPERIORITY|||||||0.69|||||||Regression, Linear|||||||0.69
72409275|NCT02556710|144327022|SUPERIORITY|||||||0.35||||||Adjusted for baseline WOMAC Score.|ANCOVA|||||||0.35
72409276|NCT04011475|144327043|OTHER|||||||0.0276|||||||Log Rank|||||||0.0276
72409277|NCT04011475|144327043|OTHER||Hazard Ratio (HR)|0.875||||0.6665|TWO_SIDED|95.0|0.47|1.604|||Regression, Cox||Hazard Ratio (HR) was from Cox regression comparing group A versus group B using group B as reference.|||1.604|0.47|0.6665
72574286|NCT02740699|144675043|SUPERIORITY|||||||0.006|||||||Regression, Linear|||||||0.006
72574287|NCT03783039|144675046|NON_INFERIORITY|10% margin|Risk Difference (RD)|0.0605|||<|0.0001|ONE_SIDED|97.5|-0.0189|||Testing whether the group difference in proportion of successes is \>-0.1 (Test Group - Control Group)|Farrington-Manning method||||||-0.0189|<0.0001
72574288|NCT03783039|144675047|OTHER||Difference in proportion of successes|0.0992|||||TWO_SIDED|95.0|0.0078|0.1906|||Farrington-Manning Method|Difference in proportion of successes (Test Group - Control Group)||||0.1906|0.0078|
72409278|NCT04011475|144327043|OTHER||Hazard Ratio (HR)|2.377||||0.031|TWO_SIDED|95.0|1.083|5.221|||Regression, Cox||Hazard Ratio (HR) was from Cox regression comparing group A versus group C using group C as reference.|||5.221|1.083|0.0310
72574289|NCT03783039|144675048|OTHER||Difference in proportion of successes|0.0275|||||TWO_SIDED|95.0|-0.0312|0.0863|||Farrington-Manning Method|Difference in proportion of successes (Test Group - Control Group)||||0.0863|-0.0312|
72576787|NCT00261443|144680651|SUPERIORITY_OR_OTHER_LEGACY||Difference|-2.92|||<|0.001|TWO_SIDED|95.0|-4.38|-1.46||Mean change from baseline: ANOVA model, controlling for treatment, mood stabilizer, index mood episode, and baseline value. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 44 Comparison||-1.46|-4.38|<0.001
72576788|NCT00261443|144680651|SUPERIORITY_OR_OTHER_LEGACY||Difference|-3.08|||<|0.001|TWO_SIDED|95.0|-4.59|-1.57||Mean change from baseline: ANOVA model, controlling for treatment, mood stabilizer, index mood episode, and baseline value. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 48 Comparison||-1.57|-4.59|<0.001
72576789|NCT00261443|144680651|SUPERIORITY_OR_OTHER_LEGACY||Difference|-3.04|||<|0.001|TWO_SIDED|95.0|-4.55|-1.54||Mean change from baseline: ANOVA model, controlling for treatment, mood stabilizer, index mood episode, and baseline value. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 52 Comparison||-1.54|-4.55|<0.001
72576790|NCT00261443|144680653|SUPERIORITY_OR_OTHER_LEGACY||Difference|0.2||||0.59|TWO_SIDED|95.0|-0.54|0.94||Baseline: ANOVA model, controlling for treatment, mood stabilizer, and index mood episode. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Baseline Comparison||0.94|-0.54|0.590
72576791|NCT00261443|144680653|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.5||||0.371|TWO_SIDED|95.0|-1.59|0.6||Baseline: ANOVA model, controlling for treatment, mood stabilizer, and index mood episode. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 4 Comparison||0.60|-1.59|0.371
72576792|NCT00261443|144680653|SUPERIORITY_OR_OTHER_LEGACY||Difference|-1.04||||0.113|TWO_SIDED|95.0|-2.33|0.25||Baseline: ANOVA model, controlling for treatment, mood stabilizer, and index mood episode. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 8 Comparison||0.25|-2.33|0.113
72576793|NCT00261443|144680653|SUPERIORITY_OR_OTHER_LEGACY||Difference|-1.0||||0.128|TWO_SIDED|95.0|-2.28|0.29||Baseline: ANOVA model, controlling for treatment, mood stabilizer, and index mood episode. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 12 Comparison||0.29|-2.28|0.128
72576794|NCT00261443|144680653|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.85||||0.205|TWO_SIDED|95.0|-2.16|0.47||Baseline: ANOVA model, controlling for treatment, mood stabilizer, and index mood episode. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 16 Comparison||0.47|-2.16|0.205
72576795|NCT00261443|144680653|SUPERIORITY_OR_OTHER_LEGACY||Difference|-1.13||||0.125|TWO_SIDED|95.0|-2.59|0.32||Baseline: ANOVA model, controlling for treatment, mood stabilizer, and index mood episode. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 20 Comparison||0.32|-2.59|0.125
72576796|NCT00261443|144680653|SUPERIORITY_OR_OTHER_LEGACY||Difference|-1.43||||0.061|TWO_SIDED|95.0|-2.92|0.06||Baseline: ANOVA model, controlling for treatment, mood stabilizer, and index mood episode. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 24 Comparison||0.06|-2.92|0.061
72538078|NCT03692078|144605800|EQUIVALENCE|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 7. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|-0.208||||0.2371|TWO_SIDED|95.0|-0.483|0.068|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 7. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 7. (mITT Population)||0.068|-0.483|0.2371
72538079|NCT03692078|144605800|EQUIVALENCE|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 5. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|-0.101||||0.9133|TWO_SIDED|95.0|-0.371|0.169|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 5. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 5. (mITT Population)||0.169|-0.371|0.9133
72538080|NCT03692078|144605800|EQUIVALENCE|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 7. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|-0.095||||0.9432|TWO_SIDED|95.0|-0.37|0.18|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 7. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 7. (mITT Population)||0.180|-0.370|0.9432
72538081|NCT03692078|144605802|EQUIVALENCE|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 5. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|4.513|||<|0.0001|TWO_SIDED|95.0|4.383|4.643|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 5. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 5. (mITT Population)||4.643|4.383|<.0001
72538082|NCT03692078|144605802|EQUIVALENCE|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 7. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|4.491|||<|0.0001|TWO_SIDED|95.0|4.371|4.61|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 7. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 7. (mITT Population)||4.610|4.371|<.0001
72538083|NCT03692078|144605802|EQUIVALENCE|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 5. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|4.15|||<|0.0001|TWO_SIDED|95.0|4.027|4.272|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 5. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 5. (mITT Population)||4.272|4.027|<.0001
72538084|NCT03692078|144605802|EQUIVALENCE|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 7. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|4.128|||<|0.0001|TWO_SIDED|95.0|4.014|4.242|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 7. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 7. (mITT Population)||4.242|4.014|<.0001
72538085|NCT03692078|144605802|EQUIVALENCE|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 5. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|4.176|||<|0.0001|TWO_SIDED|95.0|4.051|4.301|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 5. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 5. (mITT Population)||4.301|4.051|<.0001
72538086|NCT03692078|144605802|EQUIVALENCE|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 7. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|4.139|||<|0.0001|TWO_SIDED|95.0|4.024|4.254|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 7. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 7. (mITT Population)||4.254|4.024|<.0001
72538087|NCT03692078|144605802|EQUIVALENCE|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 5. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|2.997|||<|0.0001|TWO_SIDED|95.0|2.842|3.153|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 5. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 5. (mITT Population)||3.153|2.842|<.0001
72538088|NCT03692078|144605802|EQUIVALENCE|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 7. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|2.994|||<|0.0001|TWO_SIDED|95.0|2.849|3.138|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 7. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 7. (mITT Population)||3.138|2.849|<.0001
72538089|NCT03692078|144605802|EQUIVALENCE|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 5. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|3.317|||<|0.0001|TWO_SIDED|95.0|3.164|3.47|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 5. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 5. (mITT Population)||3.470|3.164|<.0001
72538090|NCT03692078|144605802|EQUIVALENCE|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 7. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|3.342|||<|0.0001|TWO_SIDED|95.0|3.199|3.486|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 7. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 7. (mITT Population)||3.486|3.199|<.0001
72538091|NCT03692078|144605802|EQUIVALENCE|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 5. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|3.036|||<|0.0001|TWO_SIDED|95.0|2.886|3.187|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 5. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 5. (mITT Population)||3.187|2.886|<.0001
72538092|NCT03692078|144605802|EQUIVALENCE|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 7. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|3.159|||<|0.0001|TWO_SIDED|95.0|3.019|3.299|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 7. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 7. (mITT Population)||3.299|3.019|<.0001
72538093|NCT03692078|144605802|EQUIVALENCE|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 5. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-0.363||||0.0008|TWO_SIDED|95.0|-0.613|-0.113|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 5. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 5. (mITT Population)||-0.113|-0.613|0.0008
72538094|NCT03692078|144605802|EQUIVALENCE|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 7. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-0.362||||0.0003|TWO_SIDED|95.0|-0.595|-0.129|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 7. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 7. (mITT Population)||-0.129|-0.595|0.0003
72409279|NCT04011475|144327043|OTHER||Hazard Ratio (HR)|2.716||||0.0116|TWO_SIDED|95.0|1.25|5.901|||Regression, Cox||Hazard Ratio (HR) was from Cox regression comparing group B versus group C using group C as reference.|||5.901|1.250|0.0116
72627212|NCT00370292|144783417|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for 24 Hours Post-Dose (24 hours across cycles compared with pre-dose across cycles).|Repeated Measures Analysis of Variance|||||||<0.001
72538095|NCT03692078|144605802|EQUIVALENCE|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 5. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-0.337||||0.0026|TWO_SIDED|95.0|-0.588|-0.085|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 5. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 5. (mITT Population)||-0.085|-0.588|0.0026
72538096|NCT03692078|144605802|EQUIVALENCE|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 7. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-0.351||||0.0004|TWO_SIDED|95.0|-0.584|-0.118|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 7. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 7. (mITT Population)||-0.118|-0.584|0.0004
72538097|NCT03692078|144605802|EQUIVALENCE|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 5. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-1.515|||<|0.0001|TWO_SIDED|95.0|-1.8|-1.23|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 5. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 5. (mITT Population)||-1.230|-1.800|<.0001
72574290|NCT00918138|144675066|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.8|STANDARD_ERROR_OF_MEAN|7.01||0.1278|TWO_SIDED|95.0|-24.8|3.2||Comparison between saxagliptin 5 mg + metformin 1500 mg and metformin 2000 mg significant at alpha =0.05 according to sequential testing procedure|ANCOVA|Change from baseline to week 4 was analyzed with ANCOVA including treatment group, baseline value and country in the model|Estimate = adjusted mean change for saxagliptin 5 mg + metformin 1500 mg - adjusted mean change for metformin 2000 mg|With at least 36 participants per treatment group (72 total), there is 90% power to detect a difference of 18 mg/dL between the two treatment groups. Assuming approximately 20% of participants will discontinue without any valid post-randomization assessment at Week 4, a total of 90 participants (45 participants per treatment group) needed to be randomized.||3.2|-24.8|0.1278
72574291|NCT00918138|144675067|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-31.1|STANDARD_ERROR_OF_MEAN|11.8|||TWO_SIDED|95.0|-54.6|-7.7||Comparison between saxagliptin 5 mg + metformin 1500 mg and metformin 2000 mg significant at alpha =0.05 according to sequential testing procedure.|ANCOVA|Change from baseline to week 4 was analyzed with ANCOVA including treatment group, baseline value and country in the model|Estimate = adjusted mean change for saxagliptin 5 mg + metformin 1500 mg - adjusted mean change for metformin 2000 mg.|||-7.7|-54.6|
72574292|NCT00918138|144675068|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.7|STANDARD_ERROR_OF_MEAN|7.18|||TWO_SIDED|95.0|-20.0|8.5||Comparison between saxagliptin 5 mg + metformin 1500 mg and metformin 2000 mg significant at alpha =0.05 according to sequential testing procedure.|ANCOVA|Change from baseline to week 4 was analyzed with ANCOVA including treatment group, baseline value and country in the model.|Estimate = adjusted mean change for saxagliptin 5 mg + metformin 1500 mg - adjusted mean change for metformin 2000 mg|||8.5|-20.0|
72627213|NCT00370292|144783417|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for 48 Hours Post-Dose (48 hours across cycles compared with pre-dose across cycles).|Repeated Measures Analysis of Variance|||||||<0.001
72627214|NCT03545672|144783421|SUPERIORITY|||||||0.001||||||The threshold for statistical significance was p=0.05|Chi-squared|||||||0.001
72409280|NCT04011475|144327044|OTHER||Rate ratio|0.67||||0.0756|TWO_SIDED|95.0|0.43|1.04|||Z-test||The rate ratio was from Poisson regression for Group A versus Group B using Group B as the reference group.|||1.04|0.43|0.0756
72627215|NCT03545672|144783422|SUPERIORITY||||||<|0.01|||||||t-test, 2 sided|||||||<0.01
72627216|NCT00508521|144783427|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-20.75|STANDARD_ERROR_OF_MEAN|0.47871||0.0001|TWO_SIDED|95.0|-22.27348|-19.22652|||t-test, 2 sided|||This was a feasibility study. Pre and post treatment analysis was performed for the study participants.||-19.22652|-22.27348|.0001
72627217|NCT04778592|144783428|SUPERIORITY||Mean Difference (Final Values)|0.22|STANDARD_ERROR_OF_MEAN|0.291||0.4549|TWO_SIDED|95.0|-0.36|0.79|||Mixed Models Analysis|||||0.79|-0.36|0.4549
72627218|NCT04102007|144783442|OTHER|There is no statistical test for this study|Proportion of sPGA 0/1 @ WK 16|57.4|||||TWO_SIDED|95.0|51.1|63.4|||Other|There is no test of hypothesis for this study.|Non-Responder Imputation incorporating multiple imputation to handle missing due to COVID-19 for proportion calculation and Wilson score method for confidence interval construction|||63.4|51.1|
72627219|NCT04102007|144783443|OTHER|There is no statistical test for this study|Proportion of sPGA 0 @ WK 16|20.5|||||TWO_SIDED|95.0|15.4|26.0|||Other|There is no test of hypothesis for this study|Non-Responder Imputation incorporating multiple imputation to handle missing due to COVID-19 for proportion calculation and Wilson score method for confidence interval construction|||26.0|15.4|
72627220|NCT04102007|144783444|OTHER|There is no statistical test for this study|Proportion of DLQI 0 or 1 @ WK 16|40.2|||||TWO_SIDED|95.0|34.2|46.4|||Other|There is no test of hypothesis for this study.|Non-Responder Imputation incorporating multiple imputation to handle missing due to COVID-19 for proportion calculation and Wilson score method for confidence interval construction|||46.4|34.2|
72627221|NCT04102007|144783445|OTHER|There is no statistical test for this study|Proportion of PSS 0 @ WK 16|20.9|||||TWO_SIDED|95.0|16.3|26.4|||Other|There is no test of hypothesis for this study|Non-Responder Imputation incorporating multiple imputation to handle missing due to COVID-19 for proportion calculation and Wilson score method for confidence interval construction|||26.4|16.3|
72574293|NCT00699374|144675071|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.31||||0.9993|TWO_SIDED|95.0|1.14|1.5||One-sided p-value based on stratified log-rank test controlling the effects of geographic region, prior transarterial chemoembolization (TACE) and tumor invasion condition.|Log Rank|||||1.50|1.14|0.9993
72574294|NCT00699374|144675072|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.13||||0.8857|TWO_SIDED|95.0|0.99|1.3||One-sided p-value based on stratified log-rank test controlling the effects of geographic region, prior TACE, and tumor invasion condition|Log Rank|||||1.30|0.99|0.8857
72574295|NCT00699374|144675073|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.13||||0.8459|TWO_SIDED|95.0|0.98|1.31||One-sided p-value based on stratified log-rank test controlling the effects of geographic region, prior TACE and tumor invasion condition|Log Rank|||||1.31|0.98|0.8459
72574296|NCT02885181|144675087|SUPERIORITY||Least Squares (LS) Means of Differences|0.01||||0.978|TWO_SIDED|95.0||0.76|||Cochran-Mantel-Haenszel|||||0.76|- 0.74|0.978
72574297|NCT02885181|144675087|SUPERIORITY||LS Means of Differences|0.4||||0.3|TWO_SIDED|95.0||1.16|||Cochran-Mantel-Haenszel|||||1.16|- 0.36|0.300
72627222|NCT04102007|144783446|OTHER|There is no statistical test for this study|Proportion of sPGA 0/1 @ WK 52|62.3|||||TWO_SIDED|95.0|56.0|68.1|||Other|There is no test of hypothesis for this study|Non-Responder Imputation incorporating multiple imputation to handle missing due to COVID-19 for proportion calculation and Wilson score method for confidence interval construction|||68.1|56.0|
72627223|NCT04102007|144783447|OTHER|There is no statistical test for this study|Proportion of sPGA 0 @ WK 52|27.1|||||TWO_SIDED|95.0|21.9|33.0|||Other|There is no test of hypothesis for this study|Non-Responder Imputation incorporating multiple imputation to handle missing due to COVID-19 for proportion calculation and Wilson score method for confidence interval construction|||33.0|21.9|
72627224|NCT04102007|144783448|OTHER|There is no statistical test for this study|Proportion of DLQI 0 or 1 @ WK 52|47.2|||||TWO_SIDED|95.0|41.0|53.4|||Other|There is no test of hypothesis for this study.|Non-Responder Imputation incorporating multiple imputation to handle missing due to COVID-19 for proportion calculation and Wilson score method for confidence interval construction|||53.4|41.0|
72627225|NCT04102007|144783449|OTHER|There is no statistical test for this study|Proportion of PSS 0 @ WK 52|27.5|||||TWO_SIDED|95.0|22.3|33.4|||Other|There is no test of hypothesis for this study|Non-Responder Imputation incorporating multiple imputation to handle missing due to COVID-19 for proportion calculation and Wilson score method for confidence interval construction|||33.4|22.3|
72627226|NCT01453166|144783452|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|120.0|STANDARD_DEVIATION|19.0|<|0.05||95.0|100.0|140.0|||ANOVA|||"The absolute changes has been assessed by ANOVA, in which the homogeneity of variance was assessed and the Brown-Forsythe correction was used when necessary. In cases of statistically significant differences between groups, we used multiple comparisons with Bonferroni adjustment to locate the differences. Was considered statistically significant p values \<0.05. All analyzes were performed following the principle of intention to treat."||140|100|<0.05
72574298|NCT02885181|144675087|SUPERIORITY||LS Means of Differences|0.0||||0.002|TWO_SIDED|95.0|||||Cochran-Mantel-Haenszel|||||- 0.43|- 1.92|0.002
72574299|NCT02885181|144675088|SUPERIORITY||Difference in Response Rates|-5.9||||0.66|TWO_SIDED|95.0|-36.0|24.0|||Cochran-Mantel-Haenszel|||||24.0|-36.0|0.660
72574300|NCT02885181|144675088|SUPERIORITY||Difference in Response Rates|-15.9||||0.277|TWO_SIDED|95.0|-44.7|13.8|||Cochran-Mantel-Haenszel|||||13.8|-44.7|0.277
72574301|NCT02885181|144675088|SUPERIORITY||Difference in Response Rates|40.0||||0.009|TWO_SIDED|95.0|10.7|65.6|||Cochran-Mantel-Haenszel|||||65.6|10.7|0.009
72574302|NCT02885181|144675089|SUPERIORITY||Difference in Response Rates|-2.7||||0.853|TWO_SIDED|95.0|-32.0|27.5|||Cochran-Mantel-Haenszel|||||27.5|-32.0|0.853
72574303|NCT02885181|144675089|SUPERIORITY||Difference in Response Rates|-2.7||||0.852|TWO_SIDED|95.0|-32.0|27.5|||Cochran-Mantel-Haenszel|||||27.5|-32.0|0.852
72574304|NCT02885181|144675089|SUPERIORITY||Difference in Response Rates|24.9||||0.092|TWO_SIDED|95.0|-6.6|51.5|||Cochran-Mantel-Haenszel|||||51.5|-6.6|0.092
72574305|NCT02885181|144675090|SUPERIORITY||Difference in Response Rates|-8.6||||0.36|TWO_SIDED|95.0|-37.9|22.5|||Cochran-Mantel-Haenszel|||||22.5|-37.9|0.360
72574306|NCT02885181|144675090|SUPERIORITY||Difference in Response Rates|1.4||||0.896|TWO_SIDED|95.0|-28.0|31.7|||Cochran-Mantel-Haenszel|||||31.7|-28.0|0.896
72574307|NCT02885181|144675090|SUPERIORITY||Difference in Response Rates|24.5||||0.072|TWO_SIDED|95.0|-6.6|50.1|||Cochran-Mantel-Haenszel|||||50.1|-6.6|0.072
72574308|NCT02885181|144675091|SUPERIORITY||LS Means of Differences|-0.12||||0.528|TWO_SIDED|95.0|-0.49|0.25|||Cochran-Mantel-Haenszel|||||0.25|-0.49|0.528
72574309|NCT02885181|144675091|SUPERIORITY||LS Means of Differences|0.2||||0.293|TWO_SIDED|95.0|-0.17|0.57|||Cochran-Mantel-Haenszel|||||0.57|-0.17|0.293
72574310|NCT02885181|144675091|SUPERIORITY||LS Means of Differences|-0.33||||0.072|TWO_SIDED|95.0|-0.7|0.03|||Cochran-Mantel-Haenszel|||||0.03|-0.70|0.072
72627227|NCT01453166|144783453|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|78.0|STANDARD_DEVIATION|15.0||0.05||95.0|66.0|95.0|||ANOVA|||||95|66|0.05
72627228|NCT01453166|144783454|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|170.0|STANDARD_DEVIATION|39.0||0.05||95.0|140.0|220.0|||ANOVA|||"The absolute changes has been assessed by ANOVA, in which the homogeneity of variance was assessed and the Brown-Forsythe correction was used when necessary. In cases of statistically significant differences between groups, we used multiple comparisons with Bonferroni adjustment to locate the differences. Was considered statistically significant p values \<0.05. All analyzes were performed following the principle of intention to treat."||220|140|0.05
72627229|NCT01453166|144783455|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|100.0|STANDARD_DEVIATION|12.0||0.05||95.0|88.0|112.0|||ANOVA|||"The absolute changes has been assessed by ANOVA, in which the homogeneity of variance was assessed and the Brown-Forsythe correction was used when necessary. In cases of statistically significant differences between groups, we used multiple comparisons with Bonferroni adjustment to locate the differences. Was considered statistically significant p values \<0.05. All analyzes were performed following the principle of intention to treat."||112|88|0.05
72409281|NCT04011475|144327044|OTHER||Rate ratio|4.36|||<|0.0001|TWO_SIDED|95.0|2.27|8.4|||Z-test||The rate ratio was from Poisson regression for Group B versus Group C using Group C as the reference group.|||8.40|2.27|< 0.0001
72409282|NCT04011475|144327044|OTHER||Rate ratio|0.34||||0.0022|TWO_SIDED|95.0|0.17|0.68|||Z-test||The rate ratio was from Poisson regression for Group C versus Group A using Group A as the reference group.|||0.68|0.17|0.0022
72538098|NCT03692078|144605802|EQUIVALENCE|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 7. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-1.497|||<|0.0001|TWO_SIDED|95.0|-1.762|-1.231|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 7. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 7. (mITT Population)||-1.231|-1.762|<.0001
72538099|NCT03692078|144605802|EQUIVALENCE|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 5. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-1.196|||<|0.0001|TWO_SIDED|95.0|-1.477|-0.915|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 5. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 5. (mITT Population)||-0.915|-1.477|<.0001
72538100|NCT03692078|144605802|EQUIVALENCE|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 7. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-1.148|||<|0.0001|TWO_SIDED|95.0|-1.41|-0.886|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 7. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 7. (mITT Population)||-0.886|-1.410|<.0001
72538101|NCT03692078|144605802|EQUIVALENCE|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 5. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|1.113|||<|0.0001|TWO_SIDED|95.0|0.844|1.382|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 5. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 5. (mITT Population)||1.382|0.844|<.0001
72538102|NCT03692078|144605802|EQUIVALENCE|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 7. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|0.969|||<|0.0001|TWO_SIDED|95.0|0.717|1.221|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 7. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 7. (mITT Population)||1.221|0.717|<.0001
72538103|NCT03692078|144605802|EQUIVALENCE|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 5. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|1.139|||<|0.0001|TWO_SIDED|95.0|0.869|1.41|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 5. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 5. (mITT Population)||1.410|0.869|<.0001
72574311|NCT03839823|144675092|SUPERIORITY||Hazard Ratio (HR)|0.611||||0.003|TWO_SIDED|95.0|0.429|0.87|||one-sided stratified logrank test|||||0.870|0.429|0.003
72574312|NCT03839823|144675093|SUPERIORITY||Hazard Ratio (HR)|0.497||||||95.0|0.363|0.68||||||||0.680|0.363|
72574313|NCT03839823|144675094|SUPERIORITY|||||||0.02|||||||Cochran-Mantel-Haenszel|||||||0.020
72409283|NCT04011475|144327045|OTHER||Rate ratio|1.25||||0.7394|TWO_SIDED|95.0|0.34|4.65|||Z-test||The rate ratio was from Poisson regression for Group B versus Group C using Group C as the reference group.|||4.65|0.34|0.7394
72409284|NCT04011475|144327046|OTHER||Rate ratio|0.65||||0.1116|TWO_SIDED|95.0|0.38|1.11|||Z-test||The rate ratio was from Poisson regression for Group A versus Group B using Group B as the reference group.|||1.11|0.38|0.1116
72409285|NCT04011475|144327046|OTHER||Rate ratio|3.78||||0.0004|TWO_SIDED|95.0|1.81|7.88|||Z-test||The rate ratio was from Poisson regression for Group B versus Group C using Group C as the reference group.|||7.88|1.81|0.0004
72409286|NCT04011475|144327046|OTHER||Rate ratio|0.41||||0.0239|TWO_SIDED|95.0|0.19|0.89|||Z-test||The rate ratio was from Poisson regression for Group C versus Group A using Group A as the reference group.|||0.89|0.19|0.0239
72409287|NCT04011475|144327047|OTHER||Rate ratio|0.71||||0.4164|TWO_SIDED|95.0|0.32|1.61|||Z-test||The rate ratio was from Poisson regression for Group A versus Group B using Group B as the reference group.|||1.61|0.32|0.4164
72409288|NCT04011475|144327047|OTHER||Rate ratio|7.0||||0.01|TWO_SIDED|95.0|1.59|30.8|||Z-test||The rate ratio was from Poisson regression for Group B versus Group C using Group C as the reference group.|||30.8|1.59|0.0100
72409289|NCT04011475|144327047|OTHER||Rate ratio|0.2||||0.0377|TWO_SIDED|95.0|0.04|0.91|||Z-test||The rate ratio was from Poisson regression for Group C versus Group A using Group A as the reference group.|||0.91|0.04|0.0377
72409290|NCT04011475|144327048|OTHER|||||||0.2035|||||||Log Rank|||||||0.2035
72538104|NCT03692078|144605802|EQUIVALENCE|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 7. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|0.98|||<|0.0001|TWO_SIDED|95.0|0.728|1.231|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 7. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 7. (mITT Population)||1.231|0.728|<.0001
72538105|NCT03692078|144605802|EQUIVALENCE|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 5. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|-0.039||||1|TWO_SIDED|95.0|-0.34|0.262|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 5. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 5. (mITT Population)||0.262|-0.340|1.0000
72538106|NCT03692078|144605802|EQUIVALENCE|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 7. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|-0.166||||0.5184|TWO_SIDED|95.0|-0.447|0.115|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 7. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 7. (mITT Population)||0.115|-0.447|0.5184
72538107|NCT03692078|144605802|EQUIVALENCE|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 5. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|0.28||||0.0743|TWO_SIDED|95.0|-0.017|0.578|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 5. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 5. (mITT Population)||0.578|-0.017|0.0743
72538108|NCT03692078|144605802|EQUIVALENCE|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 7. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|0.183||||0.3889|TWO_SIDED|95.0|-0.095|0.462|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 7. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 7. (mITT Population)||0.462|-0.095|0.3889
72538109|NCT03692078|144605804|EQUIVALENCE|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 5. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|5.264|||<|0.0001|TWO_SIDED|95.0|5.155|5.373|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 5. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 5. (mITT Population)||5.373|5.155|<.0001
72538110|NCT03692078|144605804|EQUIVALENCE|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 7. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|5.204|||<|0.0001|TWO_SIDED|95.0|5.106|5.302|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 7. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 7. (mITT Population)||5.302|5.106|<.0001
72409291|NCT04011475|144327049|OTHER|||||||0.1858|||||||Chi-squared|Chi-square test was applied for assessing the inter-group difference.||||||0.1858
72409292|NCT04011475|144327050|OTHER|||||||0.0144|||||||Pair t-test|Pair t-test was used for assessing the intra-group difference.||||||0.0144
72409293|NCT04011475|144327050|OTHER|||||||0.9219|||||||Pair t-test|Pair t-test was used for assessing the intra-group difference.||||||0.9219
72409294|NCT04011475|144327050|OTHER|||||||0.959|||||||Pair t-test|Pair t-test was used for assessing the intra-group difference.||||||0.9590
72409295|NCT04011475|144327051|OTHER|||||||0.2909|||||||Pair t-test|Pair t-test was used for assessing the intra-group difference.||||||0.2909
72409296|NCT04011475|144327051|OTHER|||||||0.1618|||||||Pair t-test|Pair t-test was used for assessing the intra-group difference.||||||0.1618
72409297|NCT04011475|144327051|OTHER|||||||0.4695|||||||Pair t-test|Pair t-test was used for assessing the intra-group difference.||||||0.4695
72409298|NCT04011475|144327052|OTHER||||||>|0.9999|||||||Pair t-test|Pair t-test was used for assessing the intra-group difference.||||||> 0.9999
72538111|NCT03692078|144605804|EQUIVALENCE|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 5. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|5.005|||<|0.0001|TWO_SIDED|95.0|4.902|5.108|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 5. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 5. (mITT Population)||5.108|4.902|<.0001
72538112|NCT03692078|144605804|EQUIVALENCE|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 7. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|4.958|||<|0.0001|TWO_SIDED|95.0|4.864|5.051|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 7. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 7. (mITT Population)||5.051|4.864|<.0001
72538113|NCT03692078|144605804|EQUIVALENCE|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 5. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|5.114|||<|0.0001|TWO_SIDED|95.0|5.009|5.219|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 5. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 5. (mITT Population)||5.219|5.009|<.0001
72538114|NCT03692078|144605804|EQUIVALENCE|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 7. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|5.052|||<|0.0001|TWO_SIDED|95.0|4.958|5.146|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 7. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 7. (mITT Population)||5.146|4.958|<.0001
72538115|NCT03692078|144605804|EQUIVALENCE|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 5. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|4.539|||<|0.0001|TWO_SIDED|95.0|4.407|4.671|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 5. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 5. (mITT Population)||4.671|4.407|<.0001
72574314|NCT03839823|144675095|SUPERIORITY|||||||0.255|||||||Cochran-Mantel-Haenszel|||||||0.255
72574315|NCT03839823|144675096|SUPERIORITY|||||||0.116|||||||Cochran-Mantel-Haenszel|||||||0.116
72574316|NCT03839823|144675097|SUPERIORITY||Hazard Ratio (HR)|0.762|||||TWO_SIDED|95.0|0.546|1.064||||||||1.064|0.546|
72574317|NCT04228783|144675103|EQUIVALENCE|An equivalence margin of 0.5 to 2.0 was considered relevant to demonstrate the equivalence of the two products.|Ratio of GMCs|0.9|||||TWO_SIDED|95.0|0.8|1.1||||||||1.1|0.8|
72574318|NCT04228783|144675103|EQUIVALENCE|An equivalence margin of 0.5 to 2.0 was considered relevant to demonstrate the equivalence of the two products.|Ratio of GMCs|0.9|||||TWO_SIDED|95.0|0.8|1.1||||||||1.1|0.8|
72574319|NCT04228783|144675103|EQUIVALENCE|An equivalence margin of 0.5 to 2.0 was considered relevant to demonstrate the equivalence of the two products.|Ratio of GMCs|1.0|||||TWO_SIDED|95.0|0.9|1.2||||||||1.2|0.9|
72574320|NCT04228783|144675104|EQUIVALENCE|An equivalence margin of 0.5 to 2.0 was considered relevant to demonstrate the equivalence of the two products.|Ratio of GMCs|1.0|||||TWO_SIDED|95.0|0.8|1.2||||||||1.2|0.8|
72574321|NCT04228783|144675104|EQUIVALENCE|An equivalence margin of 0.5 to 2.0 was considered relevant to demonstrate the equivalence of the two products.|Ratio of GMCs|1.0|||||TWO_SIDED|95.0|0.8|1.3||||||||1.3|0.8|
72574322|NCT04228783|144675104|EQUIVALENCE|An equivalence margin of 0.5 to 2.0 was considered relevant to demonstrate the equivalence of the two products.|Ratio of GMCs|1.0|||||TWO_SIDED|95.0|0.8|1.3||||||||1.3|0.8|
72574323|NCT03151811|144675110|SUPERIORITY|||||||0.0311|||||||Log Rank|||||||0.0311
72574324|NCT01517373|144675119|SUPERIORITY_OR_OTHER||Least Squares (LS) Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.145||0.4468|TWO_SIDED|80.0|-0.21|0.17||p-value was 1-sided.|t-test, 1 sided|No adjustments were made for multiple comparisons among treatment groups.||Treatment difference and 80 percent (%) confidence interval (CI) were based on least squares (LS) mean. A mixed model repeated measure (MMRM) analysis was performed with treatment,duration of type 2 diabetes mellitus (T2DM),time and treatment-by-time interaction as fixed effects,baseline as the covariate,time was repeated for participant. Null hypothesis stated there was no difference between PF 04937319 and placebo, alternative hypothesis stated PF 04937319 was superior to placebo.||0.17|-0.21|0.4468
72574325|NCT01517373|144675119|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.146||0.0218|TWO_SIDED|80.0|-0.48|-0.11||p-value was 1-sided.|t-test, 1 sided|No adjustments were made for multiple comparisons among treatment groups.||Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant. Null hypothesis stated there was no difference between PF 04937319 and placebo, alternative hypothesis stated PF 04937319 was superior to placebo.||-0.11|-0.48|0.0218
72627230|NCT01453166|144783456|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|100.0|STANDARD_DEVIATION|30.0||0.05||95.0|77.0|137.0|||ANOVA|||"The absolute changes has been assessed by ANOVA, in which the homogeneity of variance was assessed and the Brown-Forsythe correction was used when necessary. In cases of statistically significant differences between groups, we used multiple comparisons with Bonferroni adjustment to locate the differences. Was considered statistically significant p values \<0.05. All analyzes were performed following the principle of intention to treat."||137|77|0.05
72627231|NCT00854360|144783511|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.29|STANDARD_ERROR_OF_MEAN|0.26||0.255|TWO_SIDED|95.0|-0.8|0.21||A multiplicity adjustment procedure was implemented which allowed for control of the Type I error within a particular treatment comparison, as well as within a particular endpoint, however it did not control the overall Type I error.|Repeated measures ANCOVA|The repeated measures ANCOVA included covariate adjustment for baseline, day, treatment, and the treatment by day interaction.||A priori threshold for statistical significance is p\<0.05.||0.21|-0.80|0.255
72627232|NCT00854360|144783511|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.29|STANDARD_ERROR_OF_MEAN|0.25||0.257|TWO_SIDED|95.0|-0.78|0.21||A multiplicity adjustment procedure was implemented which allowed for control of the Type I error within a particular treatment comparison, as well as within a particular endpoint, however it did not control the overall Type I error.|Repeated measures ANCOVA|The repeated measures ANCOVA included covariate adjustment for baseline, day, treatment, and the treatment by day interaction.||A priori threshold for statistical significance is p\<0.05.||0.21|-0.78|0.257
72627233|NCT00854360|144783511|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.63|STANDARD_ERROR_OF_MEAN|0.25||0.013|TWO_SIDED|95.0|-1.13|-0.13||A multiplicity adjustment procedure was implemented which allowed for control of the Type I error within a particular treatment comparison, as well as within a particular endpoint, however it did not control the overall Type I error.|Repeated measures ANCOVA|The repeated measures ANCOVA included covariate adjustment for baseline, day, treatment, and the treatment by day interaction.||A priori threshold for statistical significance is p\<0.05.||-0.13|-1.13|0.013
72627234|NCT00854360|144783512|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.27|STANDARD_ERROR_OF_MEAN|0.25||0.278|TWO_SIDED|95.0|-0.77|0.22||A multiplicity adjustment procedure was implemented which allowed for control of the Type I error within a particular treatment comparison, as well as within a particular endpoint, however it did not control the overall Type I error.|Repeated measures ANCOVA|The repeated measures ANCOVA included covariate adjustment for baseline, day, treatment, and the treatment by day interaction.||A priori threshold for statistical significance is p\<0.05.||0.22|-0.77|0.278
72538116|NCT03692078|144605804|EQUIVALENCE|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 7. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|4.415|||<|0.0001|TWO_SIDED|95.0|4.295|4.534|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 7. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 7. (mITT Population)||4.534|4.295|<.0001
72538117|NCT03692078|144605804|EQUIVALENCE|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 5. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|4.431|||<|0.0001|TWO_SIDED|95.0|4.302|4.56|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 5. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 5. (mITT Population)||4.560|4.302|<.0001
72538118|NCT03692078|144605804|EQUIVALENCE|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 7. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|4.361|||<|0.0001|TWO_SIDED|95.0|4.243|4.48|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 7. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 7. (mITT Population)||4.480|4.243|<.0001
72538119|NCT03692078|144605804|EQUIVALENCE|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 5. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|4.486|||<|0.0001|TWO_SIDED|95.0|4.359|4.612|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 5. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 5. (mITT Population)||4.612|4.359|<.0001
72538120|NCT03692078|144605804|EQUIVALENCE|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 7. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|4.588|||<|0.0001|TWO_SIDED|95.0|4.473|4.703|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 7. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 7. (mITT Population)||4.703|4.473|<.0001
72538121|NCT03692078|144605804|EQUIVALENCE|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 5. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-0.259||||0.0073|TWO_SIDED|95.0|-0.469|-0.049|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 5. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 5. (mITT Population)||-0.049|-0.469|0.0073
72538122|NCT03692078|144605804|EQUIVALENCE|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 7. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-0.246||||0.0041|TWO_SIDED|95.0|-0.438|-0.055|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 7. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 7. (mITT Population)||-0.055|-0.438|0.0041
72538123|NCT03692078|144605804|EQUIVALENCE|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 5. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-0.15||||0.308|TWO_SIDED|95.0|-0.361|0.061|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 5. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 5. (mITT Population)||0.061|-0.361|0.3080
72538124|NCT03692078|144605804|EQUIVALENCE|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 7. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-0.152||||0.1982|TWO_SIDED|95.0|-0.343|0.039|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 7. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 7. (mITT Population)||0.039|-0.343|0.1982
72538125|NCT03692078|144605804|EQUIVALENCE|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 5. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-0.725|||<|0.0001|TWO_SIDED|95.0|-0.965|-0.486|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 5. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 5. (mITT Population)||-0.486|-0.965|<.0001
72538126|NCT03692078|144605804|EQUIVALENCE|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 7. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-0.79|||<|0.0001|TWO_SIDED|95.0|-1.008|-0.571|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 7. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 7. (mITT Population)||-0.571|-1.008|<.0001
72538127|NCT03692078|144605804|EQUIVALENCE|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 5. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-0.833|||<|0.0001|TWO_SIDED|95.0|-1.069|-0.597|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 5. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 5. (mITT Population)||-0.597|-1.069|<.0001
72409299|NCT04011475|144327052|OTHER|||||||0.2516|||||||Pair t-test|Pair t-test was used for assessing the intra-group difference.||||||0.2516
72576797|NCT00261443|144680653|SUPERIORITY_OR_OTHER_LEGACY||Difference|-1.51||||0.06|TWO_SIDED|95.0|-3.07|0.06||Baseline: ANOVA model, controlling for treatment, mood stabilizer, and index mood episode. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 28 Comparison||0.06|-3.07|0.060
72409300|NCT04011475|144327052|OTHER|||||||0.0036|||||||Pair t-test|Pair t-test was used for assessing the intra-group difference.||||||0.0036
72409301|NCT04011475|144327053|OTHER|||||||0.6189|||||||Wilcoxon (Mann-Whitney)|Wilcoxon test was used for assessing the intra-group difference.||||||0.6189
72409302|NCT04011475|144327053|OTHER|||||||0.7656|||||||Wilcoxon (Mann-Whitney)|Wilcoxon test was used for assessing the intra-group difference.||||||0.7656
72574326|NCT01517373|144675119|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.47|STANDARD_ERROR_OF_MEAN|0.144||0.0006|TWO_SIDED|80.0|-0.65|-0.28||p-value was 1-sided.|t-test, 1 sided|No adjustments were made for multiple comparisons among treatment groups.||Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant. Null hypothesis stated there was no difference between PF 04937319 and placebo, alternative hypothesis stated PF 04937319 was superior to placebo.||-0.28|-0.65|0.0006
72627235|NCT00854360|144783512|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.25||0.385|TWO_SIDED|95.0|-0.7|0.27||A multiplicity adjustment procedure was implemented which allowed for control of the Type I error within a particular treatment comparison, as well as within a particular endpoint, however it did not control the overall Type I error.|Repeated measures ANCOVA|The repeated measures ANCOVA included covariate adjustment for baseline, day, treatment, and the treatment by day interaction.||A priori threshold for statistical significance is p\<0.05.||0.27|-0.70|0.385
72627236|NCT00854360|144783512|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.25||0.016|TWO_SIDED|95.0|-1.09|-0.11||A multiplicity adjustment procedure was implemented which allowed for control of the Type I error within a particular treatment comparison, as well as within a particular endpoint, however it did not control the overall Type I error.|Repeated Measures ANCOVA|The repeated measures ANCOVA included covariate adjustment for baseline, day, treatment, and the treatment by day interaction.||A priori threshold for statistical significance is p\<0.05.||-0.11|-1.09|0.016
72627237|NCT00854360|144783513|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.45|STANDARD_ERROR_OF_MEAN|0.26||0.082|TWO_SIDED|95.0|-0.95|0.06||A multiplicity adjustment procedure was implemented which allowed for control of the Type I error within a particular treatment comparison, as well as within a particular endpoint, however it did not control the overall Type I error.|Repeated measures ANCOVA|The repeated measures ANCOVA included covariate adjustment for baseline, day, treatment, and the treatment by day interaction.||A priori threshold for statistical significance is p\<0.05.||0.06|-0.95|0.082
72627238|NCT00854360|144783513|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.25||0.114|TWO_SIDED|95.0|-0.9|0.1||A multiplicity adjustment procedure was implemented which allowed for control of the Type I error within a particular treatment comparison, as well as within a particular endpoint, however it did not control the overall Type I error.|Repeated measures ANCOVA|The repeated measures ANCOVA included covariate adjustment for baseline, day, treatment, and the treatment by day interaction.||A priori threshold for statistical significance is p\<0.05.||0.10|-0.90|0.114
72627239|NCT00854360|144783513|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.83|STANDARD_ERROR_OF_MEAN|0.26||0.001|TWO_SIDED|95.0|-1.33|-0.33||A multiplicity adjustment procedure was implemented which allowed for control of the Type I error within a particular treatment comparison, as well as within a particular endpoint, however it did not control the overall Type I error.|Repeated measures ANCOVA|The repeated measures ANCOVA included covariate adjustment for baseline, day, treatment, and the treatment by day interaction.||A priori threshold for statistical significance is p\<0.05.||-0.33|-1.33|0.001
72627240|NCT00854360|144783514|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.23||0.747|TWO_SIDED|95.0|-0.52|0.37||A multiplicity adjustment procedure was implemented which allowed for control of the Type I error within a particular treatment comparison, as well as within a particular endpoint, however it did not control the overall Type I error.|ANCOVA|Results obtained from ANCOVA with treatment, baseline and center in the model.||A priori threshold for statistical significance is p\<0.05.||0.37|-0.52|0.747
72627241|NCT00854360|144783514|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.21||0.605|TWO_SIDED|95.0|-0.53|0.31||A multiplicity adjustment procedure was implemented which allowed for control of the Type I error within a particular treatment comparison, as well as within a particular endpoint, however it did not control the overall Type I error.|ANCOVA|Results obtained from ANCOVA with treatment, baseline and center in the model.||A priori threshold for statistical significance is p\<0.05.||0.31|-0.53|0.605
72627242|NCT00854360|144783514|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.39|STANDARD_ERROR_OF_MEAN|0.23||0.083|TWO_SIDED|95.0|-0.84|0.05||A multiplicity adjustment procedure was implemented which allowed for control of the Type I error within a particular treatment comparison, as well as within a particular endpoint, however it did not control the overall Type I error.|ANCOVA|Results obtained from ANCOVA with treatment, baseline and center in the model.||A priori threshold for statistical significance is p\<0.05.||0.05|-0.84|0.083
72538128|NCT03692078|144605804|EQUIVALENCE|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 7. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-0.843|||<|0.0001|TWO_SIDED|95.0|-1.059|-0.627|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 7. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 7. (mITT Population)||-0.627|-1.059|<.0001
72574327|NCT01517373|144675119|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.83|STANDARD_ERROR_OF_MEAN|0.144|<|0.0001|TWO_SIDED|80.0|-1.02|-0.65||p-value was 1-sided.|t-test, 1 sided|No adjustments were made for multiple comparisons among treatment groups.||Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant. Null hypothesis stated there was no difference between PF 04937319 and placebo, alternative hypothesis stated PF 04937319 was superior to placebo.||-0.65|-1.02|<0.0001
72409303|NCT04011475|144327053|OTHER|||||||0.3594|||||||Wilcoxon (Mann-Whitney)|Wilcoxon test was used for assessing the intra-group difference.||||||0.3594
72409304|NCT04011475|144327054|OTHER|||||||0.0483|||||||Chi-squared|Chi-square test was applied for assessing the inter-group difference.||||||0.0483
72574328|NCT01517373|144675120|SUPERIORITY_OR_OTHER||LS Mean Difference|0.02|STANDARD_ERROR_OF_MEAN|0.087||0.6112|TWO_SIDED|80.0|-0.09|0.14||P-value was 1-sided.|t-test, 1 sided|||Week 4: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.14|-0.09|0.6112
72574329|NCT01517373|144675120|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.088||0.055|TWO_SIDED|80.0|-0.25|-0.03||P-value was 1-sided.|t-test, 1 sided|||Week 4: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||-0.03|-0.25|0.0550
72574330|NCT01517373|144675120|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.24|STANDARD_ERROR_OF_MEAN|0.086||0.0032|TWO_SIDED|80.0|-0.35|-0.13||P-value was 1-sided.|t-test, 1 sided|||Week 4: Treatment difference and 80%CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||-0.13|-0.35|0.0032
72574331|NCT01517373|144675120|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.44|STANDARD_ERROR_OF_MEAN|0.086|<|0.0001|TWO_SIDED|80.0|-0.55|-0.33||P-value was 1-sided.|t-test, 1 sided|||Week 4: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||-0.33|-0.55|<0.0001
72574332|NCT01517373|144675120|SUPERIORITY_OR_OTHER||LS Mean Difference|0.03|STANDARD_ERROR_OF_MEAN|0.101||0.6146|TWO_SIDED|80.0|-0.1|0.16||P-value was 1-sided.|t-test, 1 sided|||Week 6: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.16|-0.10|0.6146
72627243|NCT00854360|144783515|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.23||0.989|TWO_SIDED|95.0|-0.45|0.46||A multiplicity adjustment procedure was implemented which allowed for control of the Type I error within a particular treatment comparison, as well as within a particular endpoint, however it did not control the overall Type I error.|Repeated measures ANCOVA|The repeated measures ANCOVA included covariate adjustment for baseline, day, treatment, and the treatment by day interaction.||A priori threshold for statistical significance is p\<0.05.||0.46|-0.45|0.989
72627244|NCT00854360|144783515|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.23||0.808|TWO_SIDED|95.0|-0.39|0.5||A multiplicity adjustment procedure was implemented which allowed for control of the Type I error within a particular treatment comparison, as well as within a particular endpoint, however it did not control the overall Type I error.|Repeated measures ANCOVA|The repeated measures ANCOVA included covariate adjustment for baseline, day, treatment, and the treatment by day interaction.||A priori threshold for statistical significance is p\<0.05.||0.50|-0.39|0.808
72627245|NCT00854360|144783515|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.29|STANDARD_ERROR_OF_MEAN|0.23||0.195|TWO_SIDED|95.0|-0.74|0.15||A multiplicity adjustment procedure was implemented which allowed for control of the Type I error within a particular treatment comparison, as well as within a particular endpoint, however it did not control the overall Type I error.|Repeated measures ANCOVA|The repeated measures ANCOVA included covariate adjustment for baseline, day, treatment, and the treatment by day interaction.||A priori threshold for statistical significance is p\<0.05.||0.15|-0.74|0.195
72627246|NCT00854360|144783516|SUPERIORITY_OR_OTHER||LS Mean Difference|0.04|STANDARD_ERROR_OF_MEAN|0.31||0.903|TWO_SIDED|95.0|-0.64|0.57||A multiplicity adjustment procedure was implemented which allowed for control of the Type I error within a particular treatment comparison, as well as within a particular endpoint, however it did not control the overall Type I error.|Repeated measures ANCOVA|The repeated measures ANCOVA included covariate adjustment for baseline, day, treatment, and the treatment by day interaction.||A priori threshold for statistical significance is p\<0.05.||0.57|-0.64|0.903
72627247|NCT00854360|144783516|SUPERIORITY_OR_OTHER||LS Mean Difference|0.02|STANDARD_ERROR_OF_MEAN|0.31||0.952|TWO_SIDED|95.0|-0.58|0.62||A multiplicity adjustment procedure was implemented which allowed for control of the Type I error within a particular treatment comparison, as well as within a particular endpoint, however it did not control the overall Type I error.|Repeated measures ANCOVA|The repeated measures ANCOVA included covariate adjustment for baseline, day, treatment, and the treatment by day interaction.||A priori threshold for statistical significance is p\<0.05.||0.62|-0.58|0.952
72627248|NCT00854360|144783516|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.3||0.187|TWO_SIDED|95.0|-0.99|0.19||A multiplicity adjustment procedure was implemented which allowed for control of the Type I error within a particular treatment comparison, as well as within a particular endpoint, however it did not control the overall Type I error.|Repeated measures ANCOVA|The repeated measures ANCOVA included covariate adjustment for baseline, day, treatment, and the treatment by day interaction.||A priori threshold for statistical significance is p\<0.05.||0.19|-0.99|0.187
72627249|NCT02441218|144783517|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.82|||<|0.0001|TWO_SIDED|95.0|0.75|0.9|||Regression, Cox||"Estimate of the hazard ratio between treatment groups based on an adjusted Cox proportional hazards model with beta-blocker intake at randomisation as a covariate.~P-value: Wald test"|||0.90|0.75|<0.0001
72627250|NCT02441218|144783518|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.91||||0.128|TWO_SIDED|95.0|0.8|1.03|||Regression, Cox||"Estimate of the hazard ratio between treatment groups based on an adjusted Cox proportional hazards model with beta-blocker intake at randomisation as a covariate.~P-value: Wald test"|||1.03|0.80|0.128
72409305|NCT05036642|144327125|OTHER|||||||0.02|||||||Wilcoxon (Mann-Whitney)|||Difference in measurements from 'no device' (baseline) to 'with device.'||||0.02
72409306|NCT05036642|144327126|OTHER|||||||0.01|||||||ANOVA|||Difference in measurements from 'no device' (baseline) to 'with device.'||||0.01
72409307|NCT05036642|144327127|OTHER|||||||0.48|||||||Wilcoxon (Mann-Whitney)|||Difference in measurements from 'no device' (baseline) to 'with device.'||||0.48
72409308|NCT00630877|144327132|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel|||||||<0.001
72574333|NCT01517373|144675120|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.101||0.2606|TWO_SIDED|80.0|-0.19|0.06||P-value was 1-sided.|t-test, 1 sided|||Week 6: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.06|-0.19|0.2606
72627251|NCT02441218|144783519|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.74|||<|0.0001|TWO_SIDED|95.0|0.66|0.83|||Regression, Cox||"Estimate of the hazard ratio between treatment groups based on an adjusted Cox proportional hazards model with beta-blocker intake at randomisation as a covariate.~P-value: Wald test"|||0.83|0.66|< 0.0001
72574334|NCT01517373|144675120|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.32|STANDARD_ERROR_OF_MEAN|0.099||0.0006|TWO_SIDED|80.0|-0.45|-0.2||P-value was 1-sided.|t-test, 1 sided|||Week 6: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||-0.20|-0.45|0.0006
72627252|NCT02441218|144783520|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.9||||0.092|TWO_SIDED|95.0|0.8|1.02|||Regression, Cox||"Estimate of the hazard ratio between treatment groups based on an adjusted Cox proportional hazards model with beta-blocker intake at randomisation as a covariate.~P-value: Wald test"|||1.02|0.80|0.092
72627253|NCT02441218|144783521|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.74||||0.014|TWO_SIDED|95.0|0.58|0.94|||Regression, Cox||"Estimate of the hazard ratio between treatment groups based on an adjusted Cox proportional hazards model with beta-blocker intake at randomisation as a covariate.~P-value: Wald test"|||0.94|0.58|0.0140
72627254|NCT02441218|144783522|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.89||||0.0027|TWO_SIDED|95.0|0.82|0.96|||Regression, Cox||"Estimate of the hazard ratio between treatment groups based on an adjusted Cox proportional hazards model with beta-blocker intake at randomisation as a covariate.~P-value: Wald test"|||0.96|0.82|0.0027
72627255|NCT02441218|144783523|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.85||||0.0002|TWO_SIDED|95.0|0.78|0.92|||Regression, Cox||"Estimate of the hazard ratio between treatment groups based on an adjusted Cox proportional hazards model with beta-blocker intake at randomisation as a covariate.~P-value: Wald test"|||0.92|0.78|0.0002
72627256|NCT02441218|144783524|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.88||||0.0013|TWO_SIDED|95.0|0.81|0.95|||Regression, Cox||"Estimate of the hazard ratio between treatment groups based on an adjusted Cox proportional hazards model with beta-blocker intake at randomisation as a covariate.~P-value: Wald test"|||0.95|0.81|0.0013
72627257|NCT02441218|144783525|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.84||||0.0002|TWO_SIDED|95.0|0.77|0.92|||Regression, Cox||"Estimate of the hazard ratio between treatment groups based on an adjusted Cox proportional hazards model with beta-blocker intake at randomisation as a covariate.~P-value: Wald test"|||0.92|0.77|0.0002
72538129|NCT03692078|144605804|EQUIVALENCE|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 5. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|0.52|||<|0.0001|TWO_SIDED|95.0|0.294|0.745|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 5. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 5. (mITT Population)||0.745|0.294|<.0001
72538130|NCT03692078|144605804|EQUIVALENCE|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 7. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|0.37|||<|0.0001|TWO_SIDED|95.0|0.163|0.577|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 7. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 7. (mITT Population)||0.577|0.163|<.0001
72538131|NCT03692078|144605804|EQUIVALENCE|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 5. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|0.628|||<|0.0001|TWO_SIDED|95.0|0.402|0.855|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 5. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 5. (mITT Population)||0.855|0.402|<.0001
72574335|NCT01517373|144675120|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.57|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001|TWO_SIDED|80.0|-0.7|-0.44||P-value was 1-sided.|t-test, 1 sided|||Week 6: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||-0.44|-0.70|<0.0001
72627258|NCT02441218|144783526|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.82|||<|0.0001|TWO_SIDED|95.0|0.74|0.89|||Regression, Cox||Estimate of the hazard ratio between treatment groups based on an adjusted Cox proportional hazards model with beta-blocker intake at randomisation as a covariate. P-value: Wald test|||0.89|0.74|< 0.0001
72627259|NCT00806585|144783544|SUPERIORITY_OR_OTHER||Difference in least squares means|-1.1||||0.253|TWO_SIDED|95.0|-3.1|0.8|||Constrained longitudinal data analysis|Model included terms for treatment, stratification factor, time, interaction of time by stratification factor and the interaction of time by treatment||||0.8|-3.1|0.253
72627260|NCT00806585|144783544|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.1||||0.919|TWO_SIDED|95.0|-2.1|1.9|||Constrained longitudinal data analysis|Model included terms for treatment, stratification factor, time, interaction of time by stratification factor and the interaction of time by treatment||||1.9|-2.1|0.919
72627261|NCT00806585|144783544|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.2||||0.829|TWO_SIDED|95.0|-2.2|1.8|||Constrained longitudinal data analysis|Model included terms for treatment, stratification factor, time, interaction of time by stratification factor and the interaction of time by treatment||||1.8|-2.2|0.829
72627262|NCT00806585|144783544|SUPERIORITY_OR_OTHER||Difference in least squares means|-2.1||||0.074|TWO_SIDED|95.0|-4.5|0.2|||Constrained longitudinal data analysis|Model included terms for treatment, stratification factor, time, interaction of time by stratification factor and the interaction of time by treatment||||0.2|-4.5|0.074
72627263|NCT00806585|144783544|SUPERIORITY_OR_OTHER||Difference in least squares means|1.0||||0.393|TWO_SIDED|95.0|-1.3|3.3|||Constrained longitudinal data analysis|Model included terms for treatment, stratification factor, time, interaction of time by stratification factor and the interaction of time by treatment||||3.3|-1.3|0.393
72627264|NCT00806585|144783544|SUPERIORITY_OR_OTHER||Difference in least squares means|2.0||||0.088|TWO_SIDED|95.0|-0.3|4.4|||Constrained longitudinal data analysis|Model included terms for treatment, stratification factor, time, interaction of time by stratification factor and the interaction of time by treatment||||4.4|-0.3|0.088
72627265|NCT00806585|144783544|SUPERIORITY_OR_OTHER||Difference in least squares means|1.9||||0.108|TWO_SIDED|95.0|-0.4|4.3|||Constrained longitudinal data analysis|Model included terms for treatment, stratification factor, time, interaction of time by stratification factor and the interaction of time by treatment||||4.3|-0.4|0.108
72627266|NCT00806585|144783545|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.9||||0.543|TWO_SIDED|95.0|-4.0|2.1|||Constrained longitudinal data analysis|Model included terms for treatment, stratification factor, time, interaction of time by stratification factor and the interaction of time by treatment||||2.1|-4.0|0.543
72409309|NCT00630877|144327134|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Spearman rank-order correlation|||||||<0.0001
72409310|NCT00630877|144327135|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Spearman rank-order correlation|||||||<0.0001
72409311|NCT00630877|144327136|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Spearman rank-order correlation|||||||<0.0001
72538132|NCT03692078|144605804|EQUIVALENCE|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 7. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|0.464|||<|0.0001|TWO_SIDED|95.0|0.257|0.67|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 7. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 7. (mITT Population)||0.670|0.257|<.0001
72538133|NCT03692078|144605804|EQUIVALENCE|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 5. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|0.053||||0.9984|TWO_SIDED|95.0|-0.2|0.306|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 5. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 5. (mITT Population)||0.306|-0.200|0.9984
72538134|NCT03692078|144605804|EQUIVALENCE|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 7. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|-0.173||||0.2491|TWO_SIDED|95.0|-0.405|0.058|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 7. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 7. (mITT Population)||0.058|-0.405|0.2491
72538135|NCT03692078|144605804|EQUIVALENCE|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 5. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|-0.054||||0.9977|TWO_SIDED|95.0|-0.304|0.195|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 5. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 5. (mITT Population)||0.195|-0.304|0.9977
72538136|NCT03692078|144605804|EQUIVALENCE|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 7. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|-0.227||||0.0554|TWO_SIDED|95.0|-0.456|0.003|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 7. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 7. (mITT Population)||0.003|-0.456|0.0554
72538137|NCT03692078|144605806|EQUIVALENCE|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 5. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|3.294|||<|0.0001|TWO_SIDED|95.0|3.208|3.379|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 5. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 5. (mITT Population)||3.379|3.208|<.0001
72627267|NCT00806585|144783545|SUPERIORITY_OR_OTHER||Difference in least squares means|-1.8||||0.246|TWO_SIDED|95.0|-4.9|1.3|||Constrained longitudinal data analysis|Model included terms for treatment, stratification factor, time, interaction of time by stratification factor and the interaction of time by treatment||||1.3|-4.9|0.246
72627268|NCT00806585|144783545|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.4||||0.821|TWO_SIDED|95.0|-3.5|2.7|||Constrained longitudinal data analysis|Model included terms for treatment, stratification factor, time, interaction of time by stratification factor and the interaction of time by treatment||||2.7|-3.5|0.821
72409312|NCT00630877|144327137|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Spearman rank-order correlation|||||||<0.0001
72574336|NCT01517373|144675120|SUPERIORITY_OR_OTHER||LS Mean Difference|0.05|STANDARD_ERROR_OF_MEAN|0.118||0.6618|TWO_SIDED|80.0|-0.1|0.2||P-value was 1-sided.|t-test, 1 sided|||Week 8: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.20|-0.10|0.6618
72538138|NCT03692078|144605806|EQUIVALENCE|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 7. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|3.262|||<|0.0001|TWO_SIDED|95.0|3.176|3.348|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 7. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 7. (mITT Population)||3.348|3.176|<.0001
72538139|NCT03692078|144605806|EQUIVALENCE|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 5. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|3.12|||<|0.0001|TWO_SIDED|95.0|3.039|3.202|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 5. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 5. (mITT Population)||3.202|3.039|<.0001
72574337|NCT01517373|144675120|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.119||0.0878|TWO_SIDED|80.0|-0.31|-0.01||P-value was 1-sided.|t-test, 1 sided|||Week 8: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||-0.01|-0.31|0.0878
72574338|NCT01517373|144675120|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.34|STANDARD_ERROR_OF_MEAN|0.117||0.0022|TWO_SIDED|80.0|-0.49|-0.19||P-value was 1-sided.|t-test, 1 sided|||Week 8: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||-0.19|-0.49|0.0022
72574339|NCT01517373|144675120|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.66|STANDARD_ERROR_OF_MEAN|0.117|<|0.0001|TWO_SIDED|80.0|-0.81|-0.51||P-value was 1-sided.|t-test, 1 sided|||Week 8: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||-0.51|-0.81|<0.0001
72574340|NCT01517373|144675121|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.09|STANDARD_ERROR_OF_MEAN|5.222||0.3446|TWO_SIDED|80.0|-8.8|4.62||P-value was 1-sided.|t-test, 1 sided|||Week 2: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||4.62|-8.80|0.3446
72574341|NCT01517373|144675121|SUPERIORITY_OR_OTHER||LS Mean Difference|-6.12|STANDARD_ERROR_OF_MEAN|5.21||0.1204|TWO_SIDED|80.0|-12.81|0.57||P-value was 1-sided.|t-test, 1 sided|||Week 2: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.57|-12.81|0.1204
72627269|NCT00806585|144783545|SUPERIORITY_OR_OTHER||Difference in least squares means|-7.0|||<|0.001|TWO_SIDED|95.0|-10.7|-3.3|||Constrained longitudinal data analysis|Model included terms for treatment, stratification factor, time, interaction of time by stratification factor and the interaction of time by treatment||||-3.3|-10.7|<0.001
72574342|NCT01517373|144675121|SUPERIORITY_OR_OTHER||LS Mean Difference|-13.74|STANDARD_ERROR_OF_MEAN|5.166||0.0041|TWO_SIDED|80.0|-20.37|-7.1||P-value was 1-sided.|t-test, 1 sided|||Week 2: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||-7.10|-20.37|0.0041
72574343|NCT01517373|144675121|SUPERIORITY_OR_OTHER||LS Mean Difference|-21.34|STANDARD_ERROR_OF_MEAN|5.192|<|0.0001|TWO_SIDED|80.0|-28.01|-14.67||P-value was 1-sided.|t-test, 1 sided|||Week 2: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||-14.67|-28.01|<0.0001
72574344|NCT01517373|144675121|SUPERIORITY_OR_OTHER||LS Mean Difference|-5.14|STANDARD_ERROR_OF_MEAN|5.191||0.1616|TWO_SIDED|80.0|-11.8|1.53||P-value was 1-sided.|t-test, 1 sided|||Week 4: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||1.53|-11.80|0.1616
72409313|NCT00630877|144327138|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||Independent groups t-test|||||||0.002
72627270|NCT00806585|144783545|SUPERIORITY_OR_OTHER||Difference in least squares means|6.1||||0.001|TWO_SIDED|95.0|2.4|9.8|||Constrained longitudinal data analysis|Model included terms for treatment, stratification factor, time, interaction of time by stratification factor and the interaction of time by treatment||||9.8|2.4|0.001
72409314|NCT00630877|144327139|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Independent groups t-test|||||||<0.001
72627271|NCT00806585|144783545|SUPERIORITY_OR_OTHER||Difference in least squares means|5.2||||0.006|TWO_SIDED|95.0|1.5|8.9|||Constrained longitudinal data analysis|Model included terms for treatment, stratification factor, time, interaction of time by stratification factor and the interaction of time by treatment||||8.9|1.5|0.006
72538140|NCT03692078|144605806|EQUIVALENCE|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 7. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|3.099|||<|0.0001|TWO_SIDED|95.0|3.017|3.181|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 7. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 7. (mITT Population)||3.181|3.017|<.0001
72538141|NCT03692078|144605806|EQUIVALENCE|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 5. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|3.182|||<|0.0001|TWO_SIDED|95.0|3.1|3.264|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 5. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 5. (mITT Population)||3.264|3.100|<.0001
72538142|NCT03692078|144605806|EQUIVALENCE|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 7. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|3.149|||<|0.0001|TWO_SIDED|95.0|3.066|3.231|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 7. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 7. (mITT Population)||3.231|3.066|<.0001
72538143|NCT03692078|144605806|EQUIVALENCE|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 5. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|2.777|||<|0.0001|TWO_SIDED|95.0|2.673|2.881|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 5. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 5. (mITT Population)||2.881|2.673|<.0001
72538144|NCT03692078|144605806|EQUIVALENCE|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 7. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|2.651|||<|0.0001|TWO_SIDED|95.0|2.546|2.756|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 7. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 7. (mITT Population)||2.756|2.546|<.0001
72538145|NCT03692078|144605806|EQUIVALENCE|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 5. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|2.72|||<|0.0001|TWO_SIDED|95.0|2.618|2.823|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 5. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 5. (mITT Population)||2.823|2.618|<.0001
72538146|NCT03692078|144605806|EQUIVALENCE|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 7. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|2.649|||<|0.0001|TWO_SIDED|95.0|2.544|2.753|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 7. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 7. (mITT Population)||2.753|2.544|<.0001
72574345|NCT01517373|144675121|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.45|STANDARD_ERROR_OF_MEAN|5.219||0.1974|TWO_SIDED|80.0|-11.15|2.26||P-value was 1-sided.|t-test, 1 sided|||Week 4: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||2.26|-11.15|0.1974
72574346|NCT01517373|144675121|SUPERIORITY_OR_OTHER||LS Mean Difference|-11.62|STANDARD_ERROR_OF_MEAN|5.14||0.0122|TWO_SIDED|80.0|-18.22|-5.02||P-value was 1-sided.|t-test, 1 sided|||Week 4: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||-5.02|-18.22|0.0122
72574347|NCT01517373|144675121|SUPERIORITY_OR_OTHER||LS Mean Difference|-24.79|STANDARD_ERROR_OF_MEAN|5.129|<|0.0001|TWO_SIDED|80.0|-31.37|-18.2||P-value was 1-sided.|t-test, 1 sided|||Week 4: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||-18.20|-31.37|<0.0001
72574348|NCT01517373|144675121|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.97|STANDARD_ERROR_OF_MEAN|5.674||0.3645|TWO_SIDED|80.0|-9.26|5.32||P-value was 1-sided.|t-test, 1 sided|||Week 6: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||5.32|-9.26|0.3645
72538147|NCT03692078|144605806|EQUIVALENCE|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 5. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|2.751|||<|0.0001|TWO_SIDED|95.0|2.651|2.851|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 5. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 5. (mITT Population)||2.851|2.651|<.0001
72538148|NCT03692078|144605806|EQUIVALENCE|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 7. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|2.819|||<|0.0001|TWO_SIDED|95.0|2.718|2.919|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 7. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 7. (mITT Population)||2.919|2.718|<.0001
72538149|NCT03692078|144605806|EQUIVALENCE|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 5. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-0.173||||0.0377|TWO_SIDED|95.0|-0.34|-0.006|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 5. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 5. (mITT Population)||-0.006|-0.340|0.0377
72538150|NCT03692078|144605806|EQUIVALENCE|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 7. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-0.163||||0.0643|TWO_SIDED|95.0|-0.331|0.006|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 7. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 7. (mITT Population)||0.006|-0.331|0.0643
72538151|NCT03692078|144605806|EQUIVALENCE|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 5. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-0.112||||0.3875|TWO_SIDED|95.0|-0.279|0.056|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 5. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 5. (mITT Population)||0.056|-0.279|0.3875
72538152|NCT03692078|144605806|EQUIVALENCE|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 7. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-0.113||||0.3725|TWO_SIDED|95.0|-0.28|0.054|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 7. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 7. (mITT Population)||0.054|-0.280|0.3725
72538153|NCT03692078|144605806|EQUIVALENCE|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 5. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-0.516|||<|0.0001|TWO_SIDED|95.0|-0.706|-0.327|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 5. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 5. (mITT Population)||-0.327|-0.706|<.0001
72574349|NCT01517373|144675121|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.93|STANDARD_ERROR_OF_MEAN|5.676||0.3672|TWO_SIDED|80.0|-9.22|5.36||P-value was 1-sided.|t-test, 1 sided|||Week 6: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||5.36|-9.22|0.3672
72574350|NCT01517373|144675121|SUPERIORITY_OR_OTHER||LS Mean Difference|-7.5|STANDARD_ERROR_OF_MEAN|5.598||0.0906|TWO_SIDED|80.0|-14.69|-0.31||P-value was 1-sided.|t-test, 1 sided|||Week 6: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||-0.31|-14.69|0.0906
72574351|NCT01517373|144675121|SUPERIORITY_OR_OTHER||LS Mean Difference|-19.69|STANDARD_ERROR_OF_MEAN|5.624||0.0003|TWO_SIDED|80.0|-26.91|-12.46||P-value was 1-sided.|t-test, 1 sided|||Week 6: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||-12.46|-26.91|0.0003
72574352|NCT01517373|144675121|SUPERIORITY_OR_OTHER||LS Mean Difference|-5.18|STANDARD_ERROR_OF_MEAN|5.534||0.1748|TWO_SIDED|80.0|-12.29|1.93||P-value was 1-sided.|t-test, 1 sided|||Week 8: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||1.93|-12.29|0.1748
72627272|NCT00806585|144783545|SUPERIORITY_OR_OTHER||Difference in least squares means|6.7|||<|0.001|TWO_SIDED|95.0|3.0|10.4|||Constrained longitudinal data analysis|Model included terms for treatment, stratification factor, time, interaction of time by stratification factor and the interaction of time by treatment||||10.4|3.0|<0.001
72627273|NCT00806585|144783546|SUPERIORITY_OR_OTHER||Difference in least squares means|-1.4||||0.684|TWO_SIDED|95.0|-8.3|5.5|||ANCOVA|Fixed effects for treatment baseline, stratification, time, interaction of time by stratification and treatments factors and a random subject effect||||5.5|-8.3|0.684
72627274|NCT00806585|144783546|SUPERIORITY_OR_OTHER||Difference in least squares means|1.8||||0.597|TWO_SIDED|95.0|-5.0|8.7|||ANCOVA|Fixed effects for treatment baseline, stratification, time, interaction of time by stratification and treatments factors and a random subject effect||||8.7|-5.0|0.597
72627275|NCT00806585|144783546|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.9||||0.793|TWO_SIDED|95.0|-7.6|5.8|||ANCOVA|Fixed effects for treatment baseline, stratification, time, interaction of time by stratification and treatments factors and a random subject effect||||5.8|-7.6|0.793
72627276|NCT00806585|144783546|SUPERIORITY_OR_OTHER||Difference in least squares means|0.8||||0.854|TWO_SIDED|95.0|-7.6|9.2|||ANCOVA|Fixed effects for treatment baseline, stratification, time, interaction of time by stratification and treatments factors and a random subject effect||||9.2|-7.6|0.854
72627277|NCT00806585|144783547|SUPERIORITY_OR_OTHER||Difference in least squares means|-1.9||||0.006|TWO_SIDED|95.0|-3.2|-0.5|||Constrained longitudinal data analysis|Model included terms for treatment, stratification factor, time, interaction of time by stratification factor and the interaction of time by treatment||||-0.5|-3.2|0.006
72627278|NCT00806585|144783547|SUPERIORITY_OR_OTHER||Difference in least squares means|-2.0||||0.004|TWO_SIDED|95.0|-3.3|-0.6|||Constrained longitudinal data analysis|Model included terms for treatment, stratification factor, time, interaction of time by stratification factor and the interaction of time by treatment||||-0.6|-3.3|0.004
72538154|NCT03692078|144605806|EQUIVALENCE|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 7. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-0.611|||<|0.0001|TWO_SIDED|95.0|-0.802|-0.42|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 7. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 7. (mITT Population)||-0.420|-0.802|<.0001
72538155|NCT03692078|144605806|EQUIVALENCE|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 5. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-0.573|||<|0.0001|TWO_SIDED|95.0|-0.76|-0.386|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 5. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 5. (mITT Population)||-0.386|-0.760|<.0001
72538156|NCT03692078|144605806|EQUIVALENCE|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 7. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-0.613|||<|0.0001|TWO_SIDED|95.0|-0.803|-0.423|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 7. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 7. (mITT Population)||-0.423|-0.803|<.0001
72538157|NCT03692078|144605806|EQUIVALENCE|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 5. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|0.369|||<|0.0001|TWO_SIDED|95.0|0.19|0.548|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 5. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 5. (mITT Population)||0.548|0.190|<.0001
72627279|NCT00806585|144783547|SUPERIORITY_OR_OTHER||Diffference in least squares means|-1.3||||0.066|TWO_SIDED|95.0|-2.6|0.1|||Constrained longitudinal data analysis|Model included terms for treatment, stratification factor, time, interaction of time by stratification factor and the interaction of time by treatment||||0.1|-2.6|0.066
72627280|NCT00806585|144783547|SUPERIORITY_OR_OTHER||Difference in least squares means|-2.2||||0.008|TWO_SIDED|95.0|-3.7|-0.6|||Constrained longitudinal data analysis|Model included terms for treatment, stratification factor, time, interaction of time by stratification factor and the interaction of time by treatment||||-0.6|-3.7|0.008
72627281|NCT00806585|144783548|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.18||||0.152|TWO_SIDED|95.0|-0.44|0.07|||Constrained longitudinal data analysis|Model included terms for treatment, stratification factor, time, interaction of time by stratification factor and the interaction of time by treatment||||0.07|-0.44|0.152
72627282|NCT00806585|144783548|SUPERIORITY_OR_OTHER||Difference in least sqaures means|-0.28||||0.035|TWO_SIDED|95.0|-0.54|-0.02|||Constrained longitudinal data analysis|Model included terms for treatment, stratification factor, time, interaction of time by stratification factor and the interaction of time by treatment||||-0.02|-0.54|0.035
72627283|NCT00806585|144783548|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.22||||0.095|TWO_SIDED|95.0|-0.48|0.04|||Constrained longitudinal data analysis|Model included terms for treatment, stratification factor, time, interaction of time by stratification factor and the interaction of time by treatment||||0.04|-0.48|0.095
72627284|NCT00806585|144783548|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.32||||0.045|TWO_SIDED|95.0|-0.63|-0.01|||Constrained longitudinal data analysis|Model included terms for treatment, stratification factor, time, interaction of time by stratification factor and the interaction of time by treatment||||-0.01|-0.63|0.045
72538158|NCT03692078|144605806|EQUIVALENCE|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 7. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|0.28||||0.0003|TWO_SIDED|95.0|0.099|0.462|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 7. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 7. (mITT Population)||0.462|0.099|0.0003
72538159|NCT03692078|144605806|EQUIVALENCE|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 5. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|0.431|||<|0.0001|TWO_SIDED|95.0|0.251|0.611|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 5. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 5. (mITT Population)||0.611|0.251|<.0001
72538160|NCT03692078|144605806|EQUIVALENCE|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 7. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|0.33|||<|0.0001|TWO_SIDED|95.0|0.149|0.511|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 7. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 7. (mITT Population)||0.511|0.149|<.0001
72538161|NCT03692078|144605806|EQUIVALENCE|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 5. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|0.026||||1|TWO_SIDED|95.0|-0.176|0.228|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 5. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 5. (mITT Population)||0.228|-0.176|1.0000
72574353|NCT01517373|144675121|SUPERIORITY_OR_OTHER||LS Mean Difference|-10.54|STANDARD_ERROR_OF_MEAN|5.566||0.0297|TWO_SIDED|80.0|-17.69|-3.38||P-value was 1-sided.|t-test, 1 sided|||Week 8: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||-3.38|-17.69|0.0297
72574354|NCT01517373|144675121|SUPERIORITY_OR_OTHER||LS Mean Difference|-12.44|STANDARD_ERROR_OF_MEAN|5.469||0.0118|TWO_SIDED|80.0|-19.47|-5.41||P-value was 1-sided.|t-test, 1 sided|||Week 8: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||-5.41|-19.47|0.0118
72574355|NCT01517373|144675121|SUPERIORITY_OR_OTHER||LS Mean Difference|-27.0|STANDARD_ERROR_OF_MEAN|5.48|<|0.0001|TWO_SIDED|80.0|-34.04|-19.96||P-value was 1-sided.|t-test, 1 sided|||Week 8: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||-19.96|-34.04|<0.0001
72574356|NCT01517373|144675121|SUPERIORITY_OR_OTHER||LS Mean Difference|-8.03|STANDARD_ERROR_OF_MEAN|6.281||0.1012|TWO_SIDED|80.0|-16.1|0.04||P-value was 1-sided.|t-test, 1 sided|||Week 12: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.04|-16.10|0.1012
72627285|NCT00474903|144783549|SUPERIORITY_OR_OTHER|||||||0.0955|||||||Wilcoxon (Mann-Whitney)|||||||0.0955
72627286|NCT00474903|144783549|SUPERIORITY_OR_OTHER|||||||0.0204|||||||Wilcoxon (Mann-Whitney)|||||||0.0204
72538162|NCT03692078|144605806|EQUIVALENCE|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 7. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|-0.168||||0.1589|TWO_SIDED|95.0|-0.371|0.036|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 7. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 7. (mITT Population)||0.036|-0.371|0.1589
72574357|NCT01517373|144675121|SUPERIORITY_OR_OTHER||LS Mean Difference|-10.99|STANDARD_ERROR_OF_MEAN|6.287||0.0409|TWO_SIDED|80.0|-19.07|-2.91|||t-test, 1 sided|||Week 12: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||-2.91|-19.07|0.0409
72627287|NCT01103414|144783566|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-9.1|STANDARD_ERROR_OF_MEAN|6.77||0.1819|TWO_SIDED|95.0|-22.4|4.3|||ANCOVA|||||4.3|-22.4|0.1819
72627288|NCT01103414|144783566|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-18.4|STANDARD_ERROR_OF_MEAN|6.59||0.0057|TWO_SIDED|95.0|-31.4|-5.4|||ANCOVA|||||-5.4|-31.4|0.0057
72627289|NCT01103414|144783566|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-28.9|STANDARD_ERROR_OF_MEAN|6.8|<|0.0001|TWO_SIDED|95.0|-42.3|-15.6|||ANCOVA|||||-15.6|-42.3|<0.0001
72627290|NCT01103414|144783566|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-31.0|STANDARD_ERROR_OF_MEAN|6.5|<|0.0001|TWO_SIDED|95.0|-43.8|-18.2|||ANCOVA|||||-18.2|-43.8|<0.0001
72627291|NCT01103414|144783567|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.39|STANDARD_ERROR_OF_MEAN|0.175||0.0273|TWO_SIDED|95.0|-0.73|-0.04|||ANCOVA|||||-0.04|-0.73|0.0273
72627292|NCT01103414|144783567|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.79|STANDARD_ERROR_OF_MEAN|0.171|<|0.0001|TWO_SIDED|95.0|-1.13|-0.45|||ANCOVA|||||-0.45|-1.13|<0.0001
72538163|NCT03692078|144605806|EQUIVALENCE|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 5. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|-0.031||||0.9999|TWO_SIDED|95.0|-0.23|0.168|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 5. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 5. (mITT Population)||0.168|-0.230|0.9999
72538164|NCT03692078|144605806|EQUIVALENCE|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 7. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|-0.17||||0.1453|TWO_SIDED|95.0|-0.372|0.032|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 7. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 7. (mITT Population)||0.032|-0.372|0.1453
72538165|NCT03692078|144605808|EQUIVALENCE|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 5. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|1.085|||<|0.0001|TWO_SIDED|95.0|0.788|1.382|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 5. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 5. (mITT Population)||1.382|0.788|<.0001
72538166|NCT03692078|144605808|EQUIVALENCE|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 7. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|1.104|||<|0.0001|TWO_SIDED|95.0|0.807|1.4|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 7. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 7. (mITT Population)||1.400|0.807|<.0001
72538167|NCT03692078|144605808|EQUIVALENCE|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 5. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|0.606|||<|0.0001|TWO_SIDED|95.0|0.326|0.886|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 5. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 5. (mITT Population)||0.886|0.326|<.0001
72538168|NCT03692078|144605808|EQUIVALENCE|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 7. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|0.476||||0.0011|TWO_SIDED|95.0|0.192|0.76|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 7. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 7. (mITT Population)||0.760|0.192|0.0011
72538169|NCT03692078|144605808|EQUIVALENCE|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 5. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|0.505||||0.0006|TWO_SIDED|95.0|0.219|0.79|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 5. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 5. (mITT Population)||0.790|0.219|0.0006
72574358|NCT01517373|144675121|SUPERIORITY_OR_OTHER||LS Mean Difference|-14.87|STANDARD_ERROR_OF_MEAN|6.232||0.0089|TWO_SIDED|80.0|-22.88|-6.86|||t-test, 1 sided|||Week 12: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||-6.86|-22.88|0.0089
72574359|NCT01517373|144675121|SUPERIORITY_OR_OTHER||LS Mean Difference|-25.93|STANDARD_ERROR_OF_MEAN|6.233|<|0.0001|TWO_SIDED|80.0|-33.93|-17.92||P-value was 1-sided.|t-test, 1 sided|||Week 12: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||-17.92|-33.93|<0.0001
72574360|NCT01517373|144675129|SUPERIORITY_OR_OTHER||LS Mean Difference|0.33|STANDARD_ERROR_OF_MEAN|0.196||0.0898|TWO_SIDED|80.0|0.08|0.59||P-value was 2-sided.|t-test, 2 sided|||Week 2: Treatment difference and 80 percent(%) confidence interval (CI) were based on least squares (LS) mean. A mixed model repeated measure (MMRM) analysis was performed with treatment, duration of type 2 diabetes mellitus (T2DM), time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.59|0.08|0.0898
72574361|NCT01517373|144675129|SUPERIORITY_OR_OTHER||LS Mean Difference|0.37|STANDARD_ERROR_OF_MEAN|0.195||0.0555|TWO_SIDED|80.0|0.12|0.62||P-value was 2-sided.|t-test, 2 sided|||Week 2: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.62|0.12|0.0555
72574362|NCT01517373|144675129|SUPERIORITY_OR_OTHER||LS Mean Difference|0.37|STANDARD_ERROR_OF_MEAN|0.193||0.0585|TWO_SIDED|80.0|0.12|0.61||P-value was 2-sided.|t-test, 2 sided|||Week 2: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.61|0.12|0.0585
72574363|NCT01517373|144675129|SUPERIORITY_OR_OTHER||LS Mean Difference|0.39|STANDARD_ERROR_OF_MEAN|0.194||0.0454|TWO_SIDED|80.0|0.14|0.64||P-value was 2-sided.|t-test, 2 sided|||Week 2: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.64|0.14|0.0454
72574364|NCT01517373|144675129|SUPERIORITY_OR_OTHER||LS Mean Difference|0.25|STANDARD_ERROR_OF_MEAN|0.235||0.2819|TWO_SIDED|80.0|-0.05|0.55||P-value was 2-sided.|t-test, 2 sided|||Week 4: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.55|-0.05|0.2819
72574365|NCT01517373|144675129|SUPERIORITY_OR_OTHER||LS Mean Difference|0.51|STANDARD_ERROR_OF_MEAN|0.235||0.0319|TWO_SIDED|80.0|0.2|0.81||P-value was 2-sided.|t-test, 2 sided|||Week 4: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.81|0.20|0.0319
72574366|NCT01517373|144675129|SUPERIORITY_OR_OTHER||LS Mean Difference|0.31|STANDARD_ERROR_OF_MEAN|0.231||0.1835|TWO_SIDED|80.0|0.01|0.6||P-value was 2-sided.|t-test, 2 sided|||Week 4: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.60|0.01|0.1835
72574367|NCT01517373|144675129|SUPERIORITY_OR_OTHER||LS Mean Difference|0.93|STANDARD_ERROR_OF_MEAN|0.231||0.0001|TWO_SIDED|80.0|0.63|1.22||P-value was 2-sided.|t-test, 2 sided|||Week 4: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||1.22|0.63|0.0001
72574368|NCT01517373|144675129|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.266||0.9689|TWO_SIDED|80.0|-0.35|0.33||P-value was 2-sided.|t-test, 2 sided|||Week 6: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.33|-0.35|0.9689
72574369|NCT01517373|144675129|SUPERIORITY_OR_OTHER||LS Mean Difference|0.32|STANDARD_ERROR_OF_MEAN|0.265||0.2221|TWO_SIDED|80.0|-0.02|0.67||P-value was 2-sided.|t-test, 2 sided|||Week 6: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.67|-0.02|0.2221
72627293|NCT01103414|144783567|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.86|STANDARD_ERROR_OF_MEAN|0.176|<|0.0001|TWO_SIDED|95.0|-1.21|-0.52|||ANCOVA|||||-0.52|-1.21|<0.0001
72627294|NCT01103414|144783567|SUPERIORITY_OR_OTHER||Median Difference (Net)|-0.98|STANDARD_ERROR_OF_MEAN|0.169|<|0.0001|TWO_SIDED|95.0|-1.32|-0.65|||ANCOVA|||||-0.65|-1.32|<0.0001
72627295|NCT03435380|144783577|SUPERIORITY||Risk Ratio (RR)|2.37||||0.019|TWO_SIDED|95.0|1.11|5.07|||Mantel Haenszel|Stratified by age at consent (25-39 vs \>=40), diagnosis (Hodgkin lymphoma vs other) and previous breast imaging exam (either mammogram or breast MRI).||||5.07|1.11|0.019
72574370|NCT01517373|144675129|SUPERIORITY_OR_OTHER||LS Mean Difference|0.28|STANDARD_ERROR_OF_MEAN|0.261||0.2774|TWO_SIDED|80.0|-0.05|0.62||P-value was 2-sided.|t-test, 2 sided|||Week 6: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.62|-0.05|0.2774
72574371|NCT01517373|144675129|SUPERIORITY_OR_OTHER||LS Mean Difference|1.09|STANDARD_ERROR_OF_MEAN|0.263|<|0.0001|TWO_SIDED|80.0|0.76|1.43||P-value was 2-sided.|t-test, 2 sided|||Week 6: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||1.43|0.76|<0.0001
72574372|NCT01517373|144675129|SUPERIORITY_OR_OTHER||LS Mean Difference|0.58|STANDARD_ERROR_OF_MEAN|0.314||0.0667|TWO_SIDED|80.0|0.17|0.98||P-value was 2-sided.|t-test, 2 sided|||Week 8: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.98|0.17|0.0667
72574373|NCT01517373|144675129|SUPERIORITY_OR_OTHER||LS Mean Difference|0.78|STANDARD_ERROR_OF_MEAN|0.314||0.0133|TWO_SIDED|80.0|0.38|1.19||P-value was 2-sided.|t-test, 2 sided|||Week 8: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||1.19|0.38|0.0133
72627296|NCT03435380|144783577|SUPERIORITY||Risk Ratio (RR)|1.96||||0.092|TWO_SIDED|95.0|0.87|4.38|||Mantel Haenszel|Stratified by age at consent (25-39 vs \>=40), diagnosis (Hodgkin lymphoma vs other) and previous breast imaging exam (either mammogram or breast MRI).||||4.38|0.87|0.092
72627297|NCT02319486|144783604|SUPERIORITY_OR_OTHER||Probability of Event-Free Survival ，pEFS|0.32||||0.034|TWO_SIDED|||||stage 2 vs stage 3|pEFS||over all pEFS|||||0.034
72627298|NCT02493764|144783613|NON_INFERIORITY|Non-inferiority was declared when the upper bound of the 2-sided 95% confidence interval (CI) for the difference in mortality (IMI/REL minus PIP/TAZ) was \< 10 percentage points.|Adjusted difference in ACM|-5.3|||<|0.001|TWO_SIDED|95.0|-11.9|1.2|||t-test, 1 sided|A one-sided alpha level of 0.025 was used to declare significance.|Adjusted difference and 95% CI are based on the Miettinen \& Nurminen method.|Adjusted difference in all-cause mortality||1.2|-11.9|<0.001
72627299|NCT02493764|144783614|NON_INFERIORITY|Non-inferiority was declared when the lower bound of the 2-sided 95% CI for the difference in FCR (IMI/REL minus PIP/TAZ) was \> 12.5 percentage points.|Adjusted difference in FCR|5.0|||<|0.001|TWO_SIDED|95.0|-3.2|13.2|||t-test, 1 sided|A one-sided alpha level of 0.025 was used to declare significance.|Adjusted difference and 95% CI are based on the Miettinen \& Nurminen method.|Adjusted difference in FCR||13.2|-3.2|<0.001
72627300|NCT02493764|144783615|OTHER|Difference in % with AE vs PIP/TAZ|Difference in % with AE|-1.7|||||TWO_SIDED|95.0|-7.7|4.3||||||||4.3|-7.7|
72574374|NCT01517373|144675129|SUPERIORITY_OR_OTHER||LS Mean Difference|0.69|STANDARD_ERROR_OF_MEAN|0.308||0.026|TWO_SIDED|80.0|0.29|1.08||P-value was 2-sided.|t-test, 2 sided|||Week 8: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||1.08|0.29|0.0260
72574375|NCT01517373|144675129|SUPERIORITY_OR_OTHER||LS Mean Difference|1.63|STANDARD_ERROR_OF_MEAN|0.31|<|0.0001|TWO_SIDED|80.0|1.23|2.02||P-value was 2-sided.|t-test, 2 sided|||Week 8: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||2.02|1.23|<0.0001
72574376|NCT01517373|144675129|SUPERIORITY_OR_OTHER||LS Mean Difference|0.8|STANDARD_ERROR_OF_MEAN|0.374||0.0335|TWO_SIDED|80.0|0.32|1.28||P-value was 2-sided.|t-test, 2 sided|||Week 12: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||1.28|0.32|0.0335
72574377|NCT01517373|144675129|SUPERIORITY_OR_OTHER||LS Mean Difference|0.53|STANDARD_ERROR_OF_MEAN|0.373||0.1557|TWO_SIDED|80.0|0.05|1.01||P-value was 2-sided.|t-test, 2 sided|||Week 12: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||1.01|0.05|0.1557
72574378|NCT01517373|144675129|SUPERIORITY_OR_OTHER||LS Mean Difference|0.92|STANDARD_ERROR_OF_MEAN|0.368||0.0132|TWO_SIDED|80.0|0.45|1.39||P-value was 2-sided.|t-test, 2 sided|||Week 12: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||1.39|0.45|0.0132
72627301|NCT02493764|144783616|OTHER|Difference in % discontinuing vs PIP/TAZ|Difference in % discontinuing|-2.5|||||TWO_SIDED|95.0|-7.1|1.8||||||||1.8|-7.1|
72574379|NCT01517373|144675129|SUPERIORITY_OR_OTHER||LS Mean Difference|2.68|STANDARD_ERROR_OF_MEAN|0.37|<|0.0001|TWO_SIDED|80.0|2.2|3.15||P-value was 2-sided.|t-test, 2 sided|||Week 12: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||3.15|2.20|<0.0001
72574380|NCT01517373|144675129|SUPERIORITY_OR_OTHER||LS Mean Difference|0.96|STANDARD_ERROR_OF_MEAN|0.394||0.0158|TWO_SIDED|80.0|0.45|1.46||P-value was 2-sided.|t-test, 2 sided|||Week 14 (Follow-up): Treatment difference and 80% CI were based on LS mean. A MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||1.46|0.45|0.0158
72574381|NCT01517373|144675129|SUPERIORITY_OR_OTHER||LS Mean Difference|0.49|STANDARD_ERROR_OF_MEAN|0.392||0.2132|TWO_SIDED|80.0|-0.01|0.99||P-value was 2-sided.|t-test, 2 sided|||Week 14 (Follow-up): Treatment difference and 80% CI were based on LS mean. A MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.99|-0.01|0.2132
72574382|NCT01517373|144675129|SUPERIORITY_OR_OTHER||LS Mean Difference|0.86|STANDARD_ERROR_OF_MEAN|0.387||0.0263|TWO_SIDED|80.0|0.37|1.36||P-value was 2-sided.|t-test, 2 sided|||Week 14 (Follow-up): Treatment difference and 80% CI were based on LS mean. A MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||1.36|0.37|0.0263
72627302|NCT02493764|144783617|OTHER||Adjusted difference in ACM|-3.5|||||TWO_SIDED|95.0|-10.9|3.6|||||Adjusted difference and 95% CI are based on the Miettinen \& Nurminen method.|Adjusted difference in all-cause mortality||3.6|-10.9|
72538170|NCT03692078|144605808|EQUIVALENCE|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 7. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|0.775|||<|0.0001|TWO_SIDED|95.0|0.49|1.06|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 7. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 7. (mITT Population)||1.060|0.490|<.0001
72574383|NCT01517373|144675129|SUPERIORITY_OR_OTHER||LS Mean Difference|2.62|STANDARD_ERROR_OF_MEAN|0.39|<|0.0001|TWO_SIDED|80.0|2.12|3.12||P-value was 2-sided.|t-test, 2 sided|||Week 14 (Follow-up): Treatment difference and 80% CI were based on LS mean. A MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||3.12|2.12|<0.0001
72574384|NCT04562155|144675143|SUPERIORITY||||||=|0.0345||||||Adjusted p-value|MCP-Mod method|||Detection of dose-response: Emax model (ED50=30) Dose response relationship was assessed using the MCP-Mod method combining multiple comparison procedures (MCP) principles with modeling techniques. A generalized MCP approach (with adjustment for baseline cough count and geographic region) was applied to calculate the adjusted one-sided p-values of the contrast test. Pre-specified overall Type one error at alpha level of 0.1 (one-sided).||||= 0.0345
72627303|NCT02493764|144783618|NON_INFERIORITY|Non-inferiority was declared when the upper bound of the 2-sided 95% CI for the difference in mortality (IMI/REL minus PIP/TAZ) was ≥ 10 percentage points.|Adjusted difference in ACM|-4.6|||||TWO_SIDED|95.0|-11.0|1.7|||||Adjusted difference and 95% CI are based on the Miettinen \& Nurminen method.|Adjusted difference in all-cause mortality||1.7|-11.0|
72627304|NCT02493764|144783619|OTHER|Adjusted difference in ACM|Adjusted difference in ACM|-3.1|||||TWO_SIDED|95.0|-10.2|3.8|||||Adjusted difference and 95% CI are based on the Miettinen \& Nurminen method.|Adjusted difference in all-cause mortality||3.8|-10.2|
72627305|NCT02493764|144783620|OTHER|Difference in FCR|Adjusted difference in FCR|-1.7|||||TWO_SIDED|95.0|-11.3|7.8|||||Adjusted difference and 95% CI are based on the Miettinen \& Nurminen method.|Adjusted difference in favorable clinical response||7.8|-11.3|
72627306|NCT02493764|144783621|OTHER|Difference in FCR|Adjusted difference in FCR|-2.2|||||TWO_SIDED|95.0|-9.8|5.5|||||Adjusted difference and 95% CI are based on the Miettinen \& Nurminen method.|Adjusted difference in favorable clinical response||5.5|-9.8|
72538171|NCT03692078|144605808|EQUIVALENCE|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 5. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|-2.116|||<|0.0001|TWO_SIDED|95.0|-2.472|-1.761|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 5. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 5. (mITT Population)||-1.761|-2.472|<.0001
72574385|NCT04562155|144675143|SUPERIORITY||||||=|0.0376||||||Adjusted p-value|MCP-Mod method|||Detection of dose-response: Emax model (ED50=50) Dose response relationship was assessed using the MCP-Mod method combining multiple comparison procedures (MCP) principles with modeling techniques. A generalized MCP approach (with adjustment for baseline cough count and geographic region) was applied to calculate the adjusted one-sided p-values of the contrast test. Pre-specified overall Type one error at alpha level of 0.1 (one-sided).||||= 0.0376
72574386|NCT04562155|144675143|SUPERIORITY||||||=|0.0319||||||Adjusted p-value|MCP-Mod method|||Detection of dose-response: sigm. Emax model (ED50=30, h=3) sigm = sigmoidal h = hill parameter Dose response relationship was assessed using the MCP-Mod method combining multiple comparison procedures (MCP) principles with modeling techniques. A generalized MCP approach (with adjustment for baseline cough count and geographic region) was applied to calculate the adjusted one-sided p-values of the contrast test. Pre-specified overall Type one error at alpha level of 0.1 (one-sided).||||= 0.0319
72574387|NCT04562155|144675143|SUPERIORITY||||||=|0.0603||||||Adjusted p-value|MCP-Mod method|||Detection of dose-response: sigm. Emax model (ED50=60, h=5) sigm = sigmoidal h = hill parameter Dose response relationship was assessed using the MCP-Mod method combining multiple comparison procedures (MCP) principles with modeling techniques. A generalized MCP approach (with adjustment for baseline cough count and geographic region) was applied to calculate the adjusted one-sided p-values of the contrast test. Pre-specified overall Type one error at alpha level of 0.1 (one-sided).||||= 0.0603
72574388|NCT00790335|144675152|SUPERIORITY||Risk Ratio (RR)|0.96||||0.56|TWO_SIDED|95.0|0.82|1.11|||Cochran-Mantel-Haenszel|Adjusted for extent of DVT and for clinical center|Numerator: PCDT Arm; Denominator: Control Arm. Primary outcome = no statistically significant difference between the two arms.|||1.11|0.82|0.56
72574389|NCT00790335|144675153|SUPERIORITY||Risk Ratio (RR)|0.58||||0.38|TWO_SIDED|95.0|0.17|1.98|||Cochran-Mantel-Haenszel|Adjusted by extent of thrombus and clinical center|Numerator: PCDT Arm; Denominator: Control Arm. No statistically significant difference was seen.|||1.98|0.17|0.38
72574390|NCT00790335|144675154|SUPERIORITY||Risk Ratio (RR)|0.94||||0.39|TWO_SIDED|95.0|0.8|1.09|||Cochran-Mantel-Haenszel|Adjusted for thrombus extent and clinical center|No statistically significant difference was seen.|||1.09|0.80|0.39
72574391|NCT00790335|144675155|SUPERIORITY||Risk Ratio (RR)|0.73||||0.04|TWO_SIDED|95.0|0.54|0.98|||Cochran-Mantel-Haenszel|Adjusted by extent of DVT and clinical center|Numerator: PCDT Arm; Denominator: Control Arm|||0.98|0.54|0.04
72574392|NCT00790335|144675156|SUPERIORITY||Risk Ratio (RR)|6.18||||0.049|TWO_SIDED|95.0|0.78|49.2|||Cochran-Mantel-Haenszel||Numerator: PCDT Arm; Denominator: Control Arm. More major bleeding was observed in the PCDT Arm.|||49.2|0.78|0.049
72574393|NCT00790335|144675157|SUPERIORITY||Risk Ratio (RR)|1.52||||0.23|TWO_SIDED|95.0|0.76|3.01|||Cochran-Mantel-Haenszel||Numerator: PCDT Arm; Denominator: Control Arm|||3.01|0.76|0.23
72574394|NCT00790335|144675158|SUPERIORITY||Risk Ratio (RR)|2.64||||0.03|TWO_SIDED|95.0|1.04|6.68|||Cochran-Mantel-Haenszel||Numerator = PCDT Arm; Denominator = Control Arm. Bleeding was more frequent in the PCDT Arm.|||6.68|1.04|0.03
72574395|NCT00790335|144675159|SUPERIORITY||Risk Ratio (RR)|1.26||||0.25|TWO_SIDED|95.0|0.85|1.89|||Cochran-Mantel-Haenszel||Numerator: PCDT Arm; Denominator: Control Arm|||1.89|0.85|0.25
72574396|NCT00790335|144675160|SUPERIORITY||Risk Ratio (RR)|1.53||||0.5|TWO_SIDED|95.0|0.44|5.28|||Cochran-Mantel-Haenszel||Numerator = PCDT Arm; Denominator = Control Arm|||5.28|0.44|0.50
72574397|NCT00790335|144675161|SUPERIORITY||Risk Ratio (RR)|1.47||||0.09|TWO_SIDED|95.0|0.94|2.29|||Cochran-Mantel-Haenszel||Numerator: PCDT Arm; Denominator: Control Arm|||2.29|0.94|0.09
72574398|NCT00790335|144675163|SUPERIORITY||Risk Ratio (RR)|0.89||||0.83|TWO_SIDED|95.0|0.33|2.44|||Cochran-Mantel-Haenszel|||||2.44|0.33|0.83
72574399|NCT00790335|144675164|SUPERIORITY||Mean Difference (Net)|-1.22|STANDARD_ERROR_OF_MEAN|0.31|<|0.001|TWO_SIDED||||||Regression, Linear|Piecewise linear-regression growth-curve models with adjustment for extent of DVT, clinical center) and pre-specified baseline co-variates|Lower (better) mean scores in the PCDT Arm|||||< 0.001
72574400|NCT00790335|144675165|SUPERIORITY||Mean Difference (Net)|-1.17|STANDARD_ERROR_OF_MEAN|0.28|<|0.001|TWO_SIDED||||||Regression, Linear|Piecewise linear-regression growth-curve models with adjustment for extent of DVT, clinical center) and pre-specified baseline co-variates|Lower (better) mean scores in the PCDT Arm|||||< 0.001
72574401|NCT00790335|144675166|SUPERIORITY||Mean Difference (Net)|-1.12|STANDARD_ERROR_OF_MEAN|0.31|<|0.001|TWO_SIDED||||||Regression, Linear|Piecewise linear-regression growth-curve models with adjustment for extent of DVT, clinical center) and pre-specified baseline co-variates|Lower (better) mean scores in the PCDT Arm|||||< 0.001
72574402|NCT00790335|144675167|SUPERIORITY||Mean Difference (Net)|-1.06|STANDARD_ERROR_OF_MEAN|0.38||0.005|TWO_SIDED||||||Regression, Linear|Piecewise linear-regression growth-curve models with adjustment for extent of DVT, clinical center) and pre-specified baseline co-variates|Lower (better) mean scores in the PCDT Arm|||||0.005
72574403|NCT00790335|144675168|SUPERIORITY||Mean Difference (Net)|-0.95|STANDARD_ERROR_OF_MEAN|0.21|<|0.001|TWO_SIDED||||||Regression, Linear|Piecewise linear-regression growth-curve models with adjustment for extent of DVT, clinical center) and pre-specified baseline co-variates|Lower (better) mean scores in the PCDT Arm|||||< 0.001
72574404|NCT00790335|144675169|SUPERIORITY||Mean Difference (Net)|-0.56|STANDARD_ERROR_OF_MEAN|0.23||0.01|TWO_SIDED||||||Regression, Linear|Piecewise linear-regression growth-curve models with adjustment for extent of DVT, clinical center) and pre-specified baseline co-variates|Lower (better) mean scores in the PCDT Arm|||||0.01
72574405|NCT00790335|144675170|SUPERIORITY||Mean Difference (Net)|-1.06|STANDARD_ERROR_OF_MEAN|0.24|<|0.001|TWO_SIDED||||||Regression, Linear|Piecewise linear-regression growth-curve models with adjustment for extent of DVT, clinical center) and pre-specified baseline co-variates|Lower (better) mean scores in the PCDT Arm|||||< 0.001
72538172|NCT03692078|144605808|EQUIVALENCE|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 7. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|-2.016|||<|0.0001|TWO_SIDED|95.0|-2.376|-1.656|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 7. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 7. (mITT Population)||-1.656|-2.376|<.0001
72538173|NCT03692078|144605808|EQUIVALENCE|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 5. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|-1.605|||<|0.0001|TWO_SIDED|95.0|-1.958|-1.253|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 5. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 5. (mITT Population)||-1.253|-1.958|<.0001
72538174|NCT03692078|144605808|EQUIVALENCE|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 7. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|-1.642|||<|0.0001|TWO_SIDED|95.0|-2.003|-1.282|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 7. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 7. (mITT Population)||-1.282|-2.003|<.0001
72538175|NCT03692078|144605808|EQUIVALENCE|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 5. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|-1.578|||<|0.0001|TWO_SIDED|95.0|-1.922|-1.234|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 5. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 5. (mITT Population)||-1.234|-1.922|<.0001
72538176|NCT03692078|144605808|EQUIVALENCE|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 7. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|-1.726|||<|0.0001|TWO_SIDED|95.0|-2.074|-1.378|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 7. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 7. (mITT Population)||-1.378|-2.074|<.0001
72538177|NCT03692078|144605808|EQUIVALENCE|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 5. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-0.479||||0.1579|TWO_SIDED|95.0|-1.054|0.097|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 5. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 5. (mITT Population)||0.097|-1.054|0.1579
72538178|NCT03692078|144605808|EQUIVALENCE|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 7. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-0.628||||0.026|TWO_SIDED|95.0|-1.207|-0.048|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 7. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 7. (mITT Population)||-0.048|-1.207|0.0260
72538179|NCT03692078|144605808|EQUIVALENCE|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 5. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-0.58||||0.0483|TWO_SIDED|95.0|-1.158|-0.003|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 5. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 5. (mITT Population)||-0.003|-1.158|0.0483
72574406|NCT00790335|144675171|SUPERIORITY||Mean Difference (Net)|-0.55|STANDARD_ERROR_OF_MEAN|0.26||0.03|TWO_SIDED||||||Regression, Linear|Piecewise linear-regression growth-curve models with adjustment for extent of DVT, clinical center) and pre-specified baseline co-variates|Lower (better) mean scores in the PCDT Arm|||||0.03
72574407|NCT00790335|144675172|SUPERIORITY||Mean Difference (Net)|1.13|STANDARD_ERROR_OF_MEAN|1.26||0.37|TWO_SIDED||||||Regression, Linear|Adjusted by extent of thrombus and clinical center|No significant difference was seen in the degree of change from baseline to 24 months between the two treatment arms.|||||0.37
72574408|NCT00790335|144675173|SUPERIORITY||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|1.16||0.99|TWO_SIDED||||||Regression, Linear|Adjusted by extent of thrombus and clinical center|No difference was observed in the degree of change from baseline to 24 months in the two treatment groups.|||||0.99
72538180|NCT03692078|144605808|EQUIVALENCE|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 7. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-0.329||||0.5842|TWO_SIDED|95.0|-0.906|0.249|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 7. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 7. (mITT Population)||0.249|-0.906|0.5842
72538181|NCT03692078|144605808|EQUIVALENCE|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 5. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-3.201|||<|0.0001|TWO_SIDED|95.0|-3.856|-2.546|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 5. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 5. (mITT Population)||-2.546|-3.856|<.0001
72538182|NCT03692078|144605808|EQUIVALENCE|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 7. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-3.119|||<|0.0001|TWO_SIDED|95.0|-3.779|-2.46|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 7. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 7. (mITT Population)||-2.460|-3.779|<.0001
72538183|NCT03692078|144605808|EQUIVALENCE|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 5. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-2.69|||<|0.0001|TWO_SIDED|95.0|-3.338|-2.043|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 5. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 5. (mITT Population)||-2.043|-3.338|<.0001
72538184|NCT03692078|144605808|EQUIVALENCE|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 7. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-2.746|||<|0.0001|TWO_SIDED|95.0|-3.402|-2.09|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 7. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 7. (mITT Population)||-2.090|-3.402|<.0001
72574409|NCT00790335|144675174|SUPERIORITY||Mean Difference (Net)|4.2|STANDARD_ERROR_OF_MEAN|2.39||0.08|TWO_SIDED||||||Regression, Linear|Adjusted by extent of thrombus and clinical center|No significant difference in the change from baseline to 24 months between the two treatment arms.|||||0.08
72574410|NCT00790335|144675175|SUPERIORITY||Mean Difference (Net)|-0.33|STANDARD_ERROR_OF_MEAN|0.14||0.02|TWO_SIDED||||||Regression, Linear|Adjusted by extent of thrombus and clinical center||||||0.02
72574411|NCT00790335|144675176|SUPERIORITY||Mean Difference (Net)|-0.34|STANDARD_ERROR_OF_MEAN|0.15||0.03|TWO_SIDED||||||Regression, Linear|Adjusted by extent of thrombus and clinical center||||||0.03
72574412|NCT00790335|144675177|SUPERIORITY||Mean Difference (Net)|-0.53|STANDARD_ERROR_OF_MEAN|0.23||0.02|TWO_SIDED||||||Regression, Linear|Adjusted by extent of thrombus and clinical center||||||0.02
72574413|NCT00790335|144675178|SUPERIORITY||Mean Difference (Net)|-0.46|STANDARD_ERROR_OF_MEAN|0.23||0.05|TWO_SIDED||||||Regression, Linear|Adjusted by extent of thrombus and clinical center||||||0.05
72574414|NCT02699060|144675182|SUPERIORITY||Median Difference (Net)|-1.76|STANDARD_DEVIATION|0.8||0.002|TWO_SIDED||||||Mixed Models Analysis|||||||0.002
72574415|NCT04516759|144675188|SUPERIORITY||Risk Ratio (RR)|1.09||||0.1854|TWO_SIDED|95.0|0.9|1.32|||Chi-squared|Chi-squared test on the one-sided significance level of 2.5%||||1.32|0.9|0.1854
72574416|NCT04516759|144675189|OTHER|||||||0.0286||||||Baseline p-value|Wilcoxon (Mann-Whitney)|one-side significance level of 2.5%||||||0.0286
72574417|NCT04516759|144675189|OTHER|||||||0.0786||||||Day 7 p-value|Wilcoxon (Mann-Whitney)|one-side significance level of 2.5%||||||0.0786
72574418|NCT04516759|144675189|OTHER|||||||0.2169||||||Day 14 p-value|Wilcoxon (Mann-Whitney)|one-side significance level of 2.5%||||||0.2169
72574419|NCT04516759|144675189|OTHER|||||||0.186||||||Day 21 p-value|Wilcoxon (Mann-Whitney)|one-sided significance level of 2.5%||||||0.1860
72574420|NCT04516759|144675189|OTHER|||||||0.2256||||||Study Drug Discontinuation (SDD) p-value|Wilcoxon (Mann-Whitney)|one-sided significance level of 2.5%||||||0.2256
72574421|NCT04516759|144675190|OTHER|||||||0.4006||||||Increase in Diabetic Medication needed equal or more than 3 days|Fisher Exact|||||||0.4006
72574422|NCT04516759|144675190|OTHER|||||||0.7482||||||Diabetic Medication is stable/reduced equal or more than 3 days|Fisher Exact|||||||0.7482
72574423|NCT04516759|144675190|OTHER|||||||0.6949||||||Increase in Diabetic Medication needed at any time during the study|Fisher Exact|||||||0.6949
72574424|NCT04516759|144675190|OTHER|||||||0.5521||||||Diabetic Medication is stable/reduced at any time during the study|Fisher Exact|||||||0.5521
72574425|NCT04516759|144675191|OTHER|||||||0.5875|||||||Fisher Exact|||||||0.5875
72574426|NCT04516759|144675192|OTHER|||||||0.1129|||||||Fisher Exact|||||||0.1129
72574427|NCT04516759|144675193|SUPERIORITY|||||||0.1556|||||||Log Rank|||||||0.1556
72574428|NCT04516759|144675194|OTHER||Risk Ratio (RR)|0.41||||0.0903|TWO_SIDED|95.0|0.13|1.26|||Fisher Exact|The p-value is assessed by means of an Fisher's exact test on the one-sided significance level of 2.5%||||1.26|0.13|0.0903
72574429|NCT04516759|144675195|OTHER|||||||0.6144|||||||Fisher Exact|One-sided significance level of 2.5%||||||0.6144
72538185|NCT03692078|144605808|EQUIVALENCE|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 5. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|2.184|||<|0.0001|TWO_SIDED|95.0|1.565|2.803|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 5. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 5. (mITT Population)||2.803|1.565|<.0001
72538186|NCT03692078|144605808|EQUIVALENCE|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 7. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|2.202|||<|0.0001|TWO_SIDED|95.0|1.576|2.828|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 7. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 7. (mITT Population)||2.828|1.576|<.0001
72538187|NCT03692078|144605808|EQUIVALENCE|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 5. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|2.083|||<|0.0001|TWO_SIDED|95.0|1.461|2.704|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 5. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 5. (mITT Population)||2.704|1.461|<.0001
72538188|NCT03692078|144605808|EQUIVALENCE|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 7. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|2.501|||<|0.0001|TWO_SIDED|95.0|1.876|3.126|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 7. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 7. (mITT Population)||3.126|1.876|<.0001
72574430|NCT04516759|144675196|OTHER|||||||0.0105|||||||Fisher Exact|one-sided significance level of 2.5%||||||0.0105
72574431|NCT04516759|144675197|OTHER|||||||0.062|||||||Fisher Exact|one-sided significance level of 2.5%||||||0.062
72574432|NCT04916444|144675243|SUPERIORITY|||||||0.691|||||||ANOVA|Two-way repeated measures ANOVA||Null hypothesis is that there was no interaction between the intervention and time factors on the TWSTRS scores.||||0.691
72574433|NCT04916444|144675244|SUPERIORITY|||||||0.816|||||||ANOVA|Two-way repeated measures ANOVA||Null hypothesis is that there was no interaction between the intervention and time factors on the BDI scores.||||0.816
72574434|NCT04916444|144675245|SUPERIORITY|||||||0.167|||||||ANOVA|Two-way repeated measures ANOVA||Null hypothesis is that there was no interaction between the intervention and time factors on the time to complete the TMT-A task.||||0.167
72574435|NCT04916444|144675246|SUPERIORITY|||||||0.507|||||||ANOVA|Two-way repeated measures ANOVA||Null hypothesis is that there was no interaction between the intervention and time factors on the time to complete the TMT-A task.||||0.507
72574436|NCT04916444|144675247|SUPERIORITY|||||||0.056|||||||ANOVA|Two-way repeated measures ANOVA||||||0.056
72574437|NCT04916444|144675248|SUPERIORITY|||||||0.646|||||||ANOVA|Two-way repeated measures ANOVA||||||0.646
72574438|NCT02695537|144675259|OTHER|Single group.|||||<|0.0001||||||P-value reported above is the global test for change in seizure frequency over a 12-month period.|Wilcoxon (Mann-Whitney)|Wilcoxon signed rank test with Bonferonni multiple comparison correction was used as a post-hoc analysis to indicate direction of change.||Null hypothesis is that there was no change in seizure frequency between any two assessment time points during this period of analysis. Alternative hypothesis is that there were two or more assessment time points for which change in seizure frequency was different from zero.|Generalized least squares statistical techniques were used for modeling longitudinal data after normality of seizure frequency outcome measures were achieved through log-transformations methods. The following baseline clinical variables were adjusted for: AEDs, AEDs tried, epileptic surgery, and gender. Reported results were geometric least squares mean and its associated 95% Confidence Interval. Percentage reduction in seizure frequency relative to baseline were obtained by subtracting from 1 and then multiplying by 100 at all post-baseline timepoints.|||<0.0001
72574439|NCT02695537|144675260|OTHER|Single group.|||||<|0.0001||||||P-value reported above is the global test for change in seizure severity scores over a 12-month period.|Wilcoxon (Mann-Whitney)|Wilcoxon signed rank test with Bonferonni multiple comparison correction was used as a post-hoc analysis to indicate direction of change.||Null hypothesis is that there was no change in seizure severity scores between any two assessment time points during this period of analysis. Alternative hypothesis is that there were two or more assessment time points for which change in seizure severity scores was different from zero.|Generalized least squares statistical techniques were used for modeling longitudinal data after normality of seizure severity score outcome measures were achieved through log-transformations methods. The following baseline clinical variables were adjusted for: AEDs, AEDs tried, epileptic surgery, and gender. Reported results were geometric least squares mean and its associated 95% Confidence Interval. Percentage reduction in seizure severity relative to baseline were obtained by subtracting from 1 and then multiplying by 100 at all post-baseline timepoints.|||<0.0001
72574440|NCT02823652|144675363|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||||||<.0001
72574441|NCT02823652|144675364|SUPERIORITY|||||||0.035|||||||t-test, 2 sided|||||||0.035
72574442|NCT02823652|144675365|SUPERIORITY|||||||0.312|||||||t-test, 2 sided|||||||0.312
72574443|NCT02823652|144675366|SUPERIORITY|||||||0.11|||||||t-test, 2 sided|||||||0.11
72574444|NCT00620659|144675389|SUPERIORITY_OR_OTHER|||||||0.615||95.0|||||Mixed Models Analysis|The mixed model included terms for period and treatment.||||||0.615
72538189|NCT03692078|144605808|EQUIVALENCE|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 5. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|-0.538||||0.2085|TWO_SIDED|95.0|-1.231|0.154|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 5. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 5. (mITT Population)||0.154|-1.231|0.2085
72538190|NCT03692078|144605808|EQUIVALENCE|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 7. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|-0.289||||0.8557|TWO_SIDED|95.0|-0.988|0.41|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 7. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 7. (mITT Population)||0.410|-0.988|0.8557
72574445|NCT00620659|144675390|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin was 1.5 minutes. If the lower bound of the one-sided 95% confidence interval for MK0249 minus modafinil 200 mg was greater than -1.5 minutes, non-inferiority would be established.|Difference in Least Squares Mean|-4.11|||||TWO_SIDED|90.0|-5.92|-2.3||||||||-2.30|-5.92|
72574446|NCT00620659|144675391|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin was 1.5 minutes. If the lower bound of the one-sided 95% confidence interval for MK0249 minus modafinil 200 mg was greater than -1.5 minutes, non-inferiority would be established.|Difference in Least Squares Mean|-3.8|||||TWO_SIDED|90.0|-5.23|-2.38||||||||-2.38|-5.23|
72574447|NCT00620659|144675392|SUPERIORITY_OR_OTHER|||||||0.079||95.0|||||Mixed Models Analysis|The mixed model included terms for period and treatment.||||||0.079
72574448|NCT00620659|144675393|SUPERIORITY_OR_OTHER|||||||0.003||95.0|||||Mixed Models Analysis|The mixed model included terms for period and treatment.||||||0.003
72574449|NCT02056392|144675404|NON_INFERIORITY_OR_EQUIVALENCE|All one-sided 95% confidence intervals at each time point for the selumetinib difference versus placebo (2-sided 90% CIs) should be less than 10ms.|Mean Difference (Final Values)|-0.2|||||TWO_SIDED|90.0|-1.8|1.5|||Mixed Models Analysis|||47 evaluable volunteers gives 90% power to show non-inferiority of selumetinib versus placebo across all 10 post-dose time points, using paired T-test, 1-sided alpha=0.05 and assuming a true difference of 3 msec.||1.5|-1.8|
72574450|NCT02056392|144675404|NON_INFERIORITY_OR_EQUIVALENCE|All one-sided 95% confidence intervals at each time point for the selumetinib difference versus placebo (2-sided 90% CIs) should be less than 10ms.|Mean Difference (Final Values)|6.1|||||TWO_SIDED|90.0|4.4|7.7|||Mixed Models Analysis|||47 evaluable volunteers gives 90% power to show non-inferiority of selumetinib versus placebo across all 10 post-dose time points, using paired T-test, 1-sided alpha=0.05 and assuming a true difference of 3 msec.||7.7|4.4|
72574451|NCT02056392|144675405|NON_INFERIORITY_OR_EQUIVALENCE|All one-sided 95% confidence intervals at each time point for the selumetinib difference versus placebo (2-sided 90% CIs) should be less than 10ms.|Mean Difference (Final Values)|-0.4|||||TWO_SIDED|90.0|-2.0|1.3|||Mixed Models Analysis|||47 evaluable volunteers gives 90% power to show non-inferiority of selumetinib versus placebo across all 10 post-dose time points, using paired T-test, 1-sided alpha=0.05 and assuming a true difference of 3 msec.||1.3|-2.0|
72574452|NCT02056392|144675405|NON_INFERIORITY_OR_EQUIVALENCE|All one-sided 95% confidence intervals at each time point for the selumetinib difference versus placebo (2-sided 90% CIs) should be less than 10ms.|Mean Difference (Final Values)|9.2|||||TWO_SIDED|90.0|7.6|10.8|||Mixed Models Analysis|||47 evaluable volunteers gives 90% power to show non-inferiority of selumetinib versus placebo across all 10 post-dose time points, using paired T-test, 1-sided alpha=0.05 and assuming a true difference of 3 msec.||10.8|7.6|
72574453|NCT02056392|144675406|NON_INFERIORITY_OR_EQUIVALENCE|All one-sided 95% confidence intervals at each time point for the selumetinib difference versus placebo (2-sided 90% CIs) should be less than 10ms.|Mean Difference (Final Values)|0.9|||||TWO_SIDED|90.0|-0.7|2.5|||Mixed Models Analysis|||47 evaluable volunteers gives 90% power to show non-inferiority of selumetinib versus placebo across all 10 post-dose time points, using paired T-test, 1-sided alpha=0.05 and assuming a true difference of 3 msec.||2.5|-0.7|
72574454|NCT02056392|144675406|NON_INFERIORITY_OR_EQUIVALENCE|All one-sided 95% confidence intervals at each time point for the selumetinib difference versus placebo (2-sided 90% CIs) should be less than 10ms.|Mean Difference (Final Values)|9.9|||||TWO_SIDED|90.0|8.3|11.5|||Mixed Models Analysis|||47 evaluable volunteers gives 90% power to show non-inferiority of selumetinib versus placebo across all 10 post-dose time points, using paired T-test, 1-sided alpha=0.05 and assuming a true difference of 3 msec.||11.5|8.3|
72574455|NCT02056392|144675407|NON_INFERIORITY_OR_EQUIVALENCE|All one-sided 95% confidence intervals at each time point for the selumetinib difference versus placebo (2-sided 90% CIs) should be less than 10ms.|Mean Difference (Final Values)|0.4|||||TWO_SIDED|90.0|-1.2|2.0|||Mixed Models Analysis|||47 evaluable volunteers gives 90% power to show non-inferiority of selumetinib versus placebo across all 10 post-dose time points, using paired T-test, 1-sided alpha=0.05 and assuming a true difference of 3 msec.||2.0|-1.2|
72574456|NCT02056392|144675407|NON_INFERIORITY_OR_EQUIVALENCE|All one-sided 95% confidence intervals at each time point for the selumetinib difference versus placebo (2-sided 90% CIs) should be less than 10ms.|Mean Difference (Final Values)|10.1|||||TWO_SIDED|90.0|8.5|11.8|||Mixed Models Analysis|||47 evaluable volunteers gives 90% power to show non-inferiority of selumetinib versus placebo across all 10 post-dose time points, using paired T-test, 1-sided alpha=0.05 and assuming a true difference of 3 msec.||11.8|8.5|
72574457|NCT02056392|144675408|NON_INFERIORITY_OR_EQUIVALENCE|All one-sided 95% confidence intervals at each time point for the selumetinib difference versus placebo (2-sided 90% CIs) should be less than 10ms.|Mean Difference (Final Values)|-0.2|||||TWO_SIDED|90.0|-1.8|1.5|||Mixed Models Analysis|||47 evaluable volunteers gives 90% power to show non-inferiority of selumetinib versus placebo across all 10 post-dose time points, using paired T-test, 1-sided alpha=0.05 and assuming a true difference of 3 msec.||1.5|-1.8|
72538191|NCT03692078|144605808|EQUIVALENCE|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 5. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|-0.027||||1|TWO_SIDED|95.0|-0.713|0.658|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 5. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 5. (mITT Population)||0.658|-0.713|1.0000
72538192|NCT03692078|144605808|EQUIVALENCE|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 7. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|0.084||||1|TWO_SIDED|95.0|-0.612|0.78|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 7. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 7. (mITT Population)||0.780|-0.612|1.0000
72538193|NCT03692078|144605810|EQUIVALENCE|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 5. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|1.081|||<|0.0001|TWO_SIDED|95.0|0.679|1.484|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 5. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 5. (mITT Population)||1.484|0.679|<.0001
72538194|NCT03692078|144605810|EQUIVALENCE|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 7. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|1.309|||<|0.0001|TWO_SIDED|95.0|0.902|1.716|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 7. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 7. (mITT Population)||1.716|0.902|<.0001
72538195|NCT03692078|144605810|EQUIVALENCE|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 5. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|0.996|||<|0.0001|TWO_SIDED|95.0|0.615|1.377|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 5. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 5. (mITT Population)||1.377|0.615|<.0001
72574458|NCT02056392|144675408|NON_INFERIORITY_OR_EQUIVALENCE|All one-sided 95% confidence intervals at each time point for the selumetinib difference versus placebo (2-sided 90% CIs) should be less than 10ms.|Mean Difference (Final Values)|11.9||||||90.0|10.3|13.6|||Mixed Models Analysis|||47 evaluable volunteers gives 90% power to show non-inferiority of selumetinib versus placebo across all 10 post-dose time points, using paired T-test, 1-sided alpha=0.05 and assuming a true difference of 3 msec.||13.6|10.3|
72574459|NCT02056392|144675409|NON_INFERIORITY_OR_EQUIVALENCE|All one-sided 95% confidence intervals at each time point for the selumetinib difference versus placebo (2-sided 90% CIs) should be less than 10ms.|Mean Difference (Final Values)|-1.5|||||TWO_SIDED|90.0|-3.1|0.2|||Mixed Models Analysis|||47 evaluable volunteers gives 90% power to show non-inferiority of selumetinib versus placebo across all 10 post-dose time points, using paired T-test, 1-sided alpha=0.05 and assuming a true difference of 3 msec.||0.2|-3.1|
72574460|NCT02056392|144675409|NON_INFERIORITY_OR_EQUIVALENCE|All one-sided 95% confidence intervals at each time point for the selumetinib difference versus placebo (2-sided 90% CIs) should be less than 10ms.|Mean Difference (Final Values)|10.8|||||TWO_SIDED|90.0|9.2|12.5|||Mixed Models Analysis|||47 evaluable volunteers gives 90% power to show non-inferiority of selumetinib versus placebo across all 10 post-dose time points, using paired T-test, 1-sided alpha=0.05 and assuming a true difference of 3 msec.||12.5|9.2|
72574461|NCT02056392|144675410|NON_INFERIORITY_OR_EQUIVALENCE|All one-sided 95% confidence intervals at each time point for the selumetinib difference versus placebo (2-sided 90% CIs) should be less than 10ms.|Mean Difference (Final Values)|-1.8|||||TWO_SIDED|90.0|-3.4|-0.1|||Mixed Models Analysis|||47 evaluable volunteers gives 90% power to show non-inferiority of selumetinib versus placebo across all 10 post-dose time points, using paired T-test, 1-sided alpha=0.05 and assuming a true difference of 3 msec.||-0.1|-3.4|
72627307|NCT02493764|144783622|OTHER|Difference in favorable clinical response|Adjusted difference in FCR|6.6|||||TWO_SIDED|95.0|-4.6|18.4|||||Adjusted difference and 95% CI are based on the Miettinen \& Nurminen method.|Adjusted difference in favorable clinical response||18.4|-4.6|
72627308|NCT02493764|144783623|OTHER|Difference in FCR|Adjusted difference in FCR|-0.4|||||TWO_SIDED|95.0|-8.1|7.4|||||Adjusted difference and 95% CI are based on the Miettinen \& Nurminen method.|Adjusted difference in favorable clinical response||7.4|-8.1|
72627309|NCT02493764|144783624|OTHER|Difference in FCR|Adjusted difference in FCR|-3.4|||||TWO_SIDED|95.0|-14.3|7.5|||||Adjusted difference and 95% CI are based on the Miettinen \& Nurminen method.|Adjusted difference in favorable clinical response||7.5|-14.3|
72627310|NCT02493764|144783625|OTHER|Difference in FCR|Adjusted difference in FCR|-3.7|||||TWO_SIDED|95.0|-13.6|6.4|||||Adjusted difference and 95% CI are based on the Miettinen \& Nurminen method.|Adjusted difference in favorable clinical response||6.4|-13.6|
72627311|NCT02493764|144783626|OTHER|Difference in FCR|Adjusted difference in FCR|3.5|||||TWO_SIDED|95.0|-4.6|11.6|||||Adjusted difference and 95% CI are based on the Miettinen \& Nurminen method.|Adjusted difference in favorable clinical response||11.6|-4.6|
72627312|NCT02493764|144783627|OTHER|Difference in FCR|Adjusted difference in FCR|0.5|||||TWO_SIDED|95.0|-6.3|7.4|||||Adjusted difference and 95% CI are based on the Miettinen \& Nurminen method.|Adjusted difference in favorable clinical response||7.4|-6.3|
72627313|NCT02493764|144783628|OTHER|Difference in FCR|Adjusted difference in FCR|3.4|||||TWO_SIDED|95.0|-7.1|14.2|||||Adjusted difference and 95% CI are based on the Miettinen \& Nurminen method.|Adjusted difference in favorable clinical response||14.2|-7.1|
72538196|NCT03692078|144605810|EQUIVALENCE|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 7. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|0.728||||0.0003|TWO_SIDED|95.0|0.339|1.116|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 7. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 7. (mITT Population)||1.116|0.339|0.0003
72538197|NCT03692078|144605810|EQUIVALENCE|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 5. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|0.987|||<|0.0001|TWO_SIDED|95.0|0.593|1.381|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 5. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 5. (mITT Population)||1.381|0.593|<.0001
72538198|NCT03692078|144605810|EQUIVALENCE|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 7. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|0.865|||<|0.0001|TWO_SIDED|95.0|0.475|1.254|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 7. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 7. (mITT Population)||1.254|0.475|<.0001
72538199|NCT03692078|144605810|EQUIVALENCE|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 5. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|0.436||||0.0768|TWO_SIDED|95.0|-0.047|0.92|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 5. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 5. (mITT Population)||0.920|-0.047|0.0768
72538200|NCT03692078|144605810|EQUIVALENCE|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 7. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|0.091||||0.7155|TWO_SIDED|95.0|-0.4|0.583|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 7. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 7. (mITT Population)||0.583|-0.400|0.7155
72574462|NCT02056392|144675410|NON_INFERIORITY_OR_EQUIVALENCE|All one-sided 95% confidence intervals at each time point for the selumetinib difference versus placebo (2-sided 90% CIs) should be less than 10ms.|Mean Difference (Final Values)|8.8|||||TWO_SIDED|90.0|7.1|10.4|||Mixed Models Analysis|||47 evaluable volunteers gives 90% power to show non-inferiority of selumetinib versus placebo across all 10 post-dose time points, using paired T-test, 1-sided alpha=0.05 and assuming a true difference of 3 msec.||10.4|7.1|
72574463|NCT02056392|144675411|NON_INFERIORITY_OR_EQUIVALENCE|All one-sided 95% confidence intervals at each time point for the selumetinib difference versus placebo (2-sided 90% CIs) should be less than 10ms.|Mean Difference (Final Values)|-1.3|||||TWO_SIDED|90.0|-2.9|0.4|||Mixed Models Analysis|||47 evaluable volunteers gives 90% power to show non-inferiority of selumetinib versus placebo across all 10 post-dose time points, using paired T-test, 1-sided alpha=0.05 and assuming a true difference of 3 msec.||0.4|-2.9|
72627314|NCT02493764|144783629|OTHER|Difference in FCR|Adjusted difference in FCR|4.4|||||TWO_SIDED|95.0|-3.1|12.0|||||Adjusted difference and 95% CI are based on the Miettinen \& Nurminen method.|Adjusted difference in favorable clinical response||12.0|-3.1|
72627315|NCT02493764|144783630|OTHER|Difference in FCR|Adjusted difference in FCR|1.1|||||TWO_SIDED|95.0|-7.2|9.4|||||Adjusted difference and 95% CI are based on the Miettinen \& Nurminen method.|Adjusted difference in favorable clinical response||9.4|-7.2|
72627316|NCT02493764|144783631|OTHER|Difference in FMR|Adjusted difference in FMR|9.7|||||TWO_SIDED|95.0|1.6|17.9|||||Adjusted difference and 95% CI are based on the Miettinen \& Nurminen method.|Adjusted difference in favorable microbiological response||17.9|1.6|
72627317|NCT02493764|144783632|OTHER|Difference in FMR|Adjusted difference in FMR|6.2|||||TWO_SIDED|95.0|-2.7|15.0|||||Adjusted difference and 95% CI are based on the Miettinen \& Nurminen method.|Adjusted difference in favorable microbiological response||15.0|-2.7|
72627318|NCT02493764|144783633|OTHER|Difference in FMR|Adjusted difference in FMR|2.5|||||TWO_SIDED|95.0|-5.5|11.0|||||Adjusted difference and 95% CI are based on the Miettinen \& Nurminen method.|Adjusted difference in favorable microbiological response||11.0|-5.5|
72627319|NCT02493764|144783634|OTHER|Difference in FMR|Adjusted difference in FMR|4.7|||||TWO_SIDED|95.0|-4.0|14.1|||||Adjusted difference and 95% CI are based on the Miettinen \& Nurminen method.|Adjusted difference in favorable microbiological response||14.1|-4.0|
72627320|NCT00859833|144783635|NON_INFERIORITY_OR_EQUIVALENCE|Power calculation for equivalence: SD for adenosine = 0.59, SD for regadenoson = 0.92, true difference between groups = 0.19. With n=28, DOF = 46. Power for equivalence (with alpha = 0.05) = 0.98585.|Mean Difference (Final Values)|0.2|STANDARD_DEVIATION|0.7||0.3617|TWO_SIDED|95.0|-0.6041|0.2241|||t-test, 2 sided|||Null hypothesis is that myocardial perfusion reserve (MPR) is not different when measured with adenosine or regadenoson in patients across a broad range of body sizes.||0.2241|-0.6041|0.3617
72627321|NCT01561976|144783642|OTHER||Ratio|108.94||||0.1413|TWO_SIDED|95.0|101.01|117.5|||ANOVA||Ratio= METLEAD ForteSR-Fed/METLEAD ForteSR-Fasting|||117.50|101.01|0.1413
72627322|NCT01561976|144783642|OTHER||Ratio|107.24||||0.1413|TWO_SIDED|95.0|99.37|115.73|||ANOVA||Ratio= METLEAD G2 Forte/METLEAD ForteSR-Fasting|||115.73|99.37|0.1413
72627323|NCT01561976|144783643|OTHER||Ratio|116.5||||0.0171|TWO_SIDED|95.0|106.91|126.95|||ANOVA||Ratio= METLEAD ForteSR-Fed/METLEAD ForteSR-Fasting|||126.95|106.91|0.0171
72627324|NCT01561976|144783643|OTHER||Ratio|107.24||||0.0171|TWO_SIDED|95.0|98.35|116.94|||ANOVA||Ratio= METLEAD G2 Forte/METLEAD ForteSR-Fasting|||116.94|98.35|0.0171
72538201|NCT03692078|144605810|EQUIVALENCE|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 5. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|0.237||||0.3282|TWO_SIDED|95.0|-0.239|0.713|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 5. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 5. (mITT Population)||0.713|-0.239|0.3282
72538202|NCT03692078|144605810|EQUIVALENCE|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 7. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|-0.23||||0.3578|TWO_SIDED|95.0|-0.722|0.262|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 7. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 7. (mITT Population)||0.262|-0.722|0.3578
72574464|NCT02056392|144675411|NON_INFERIORITY_OR_EQUIVALENCE|All one-sided 95% confidence intervals at each time point for the selumetinib difference versus placebo (2-sided 90% CIs) should be less than 10ms.|Mean Difference (Final Values)|8.9|||||TWO_SIDED|90.0|7.2|10.5|||Mixed Models Analysis|||47 evaluable volunteers gives 90% power to show non-inferiority of selumetinib versus placebo across all 10 post-dose time points, using paired T-test, 1-sided alpha=0.05 and assuming a true difference of 3 msec.||10.5|7.2|
72574465|NCT02056392|144675412|NON_INFERIORITY_OR_EQUIVALENCE|All one-sided 95% confidence intervals at each time point for the selumetinib difference versus placebo (2-sided 90% CIs) should be less than 10ms.|Mean Difference (Final Values)|-4.7|||||TWO_SIDED|90.0|-6.4|-3.1|||Mixed Models Analysis|||47 evaluable volunteers gives 90% power to show non-inferiority of selumetinib versus placebo across all 10 post-dose time points, using paired T-test, 1-sided alpha=0.05 and assuming a true difference of 3 msec.||-3.1|-6.4|
72574466|NCT02056392|144675412|NON_INFERIORITY_OR_EQUIVALENCE|All one-sided 95% confidence intervals at each time point for the selumetinib difference versus placebo (2-sided 90% CIs) should be less than 10ms.|Mean Difference (Final Values)|7.6|||||TWO_SIDED|90.0|6.0|9.3|||Mixed Models Analysis|||47 evaluable volunteers gives 90% power to show non-inferiority of selumetinib versus placebo across all 10 post-dose time points, using paired T-test, 1-sided alpha=0.05 and assuming a true difference of 3 msec.||9.3|6.0|
72574467|NCT02056392|144675413|NON_INFERIORITY_OR_EQUIVALENCE|All one-sided 95% confidence intervals at each time point for the selumetinib difference versus placebo (2-sided 90% CIs) should be less than 10ms.|Mean Difference (Final Values)|-2.5|||||TWO_SIDED|90.0|-4.1|-0.9|||Mixed Models Analysis|||47 evaluable volunteers gives 90% power to show non-inferiority of selumetinib versus placebo across all 10 post-dose time points, using paired T-test, 1-sided alpha=0.05 and assuming a true difference of 3 msec.||-0.9|-4.1|
72574468|NCT02056392|144675413|NON_INFERIORITY_OR_EQUIVALENCE|All one-sided 95% confidence intervals at each time point for the selumetinib difference versus placebo (2-sided 90% CIs) should be less than 10ms.|Mean Difference (Final Values)|4.0|||||TWO_SIDED|90.0|2.4|5.7|||Mixed Models Analysis|||47 evaluable volunteers gives 90% power to show non-inferiority of selumetinib versus placebo across all 10 post-dose time points, using paired T-test, 1-sided alpha=0.05 and assuming a true difference of 3 msec.||5.7|2.4|
72574469|NCT03867097|144675447|SUPERIORITY||LS mean difference in change|-0.77|STANDARD_ERROR_OF_MEAN|4.047||0.8498|TWO_SIDED|95.0|-9.04|7.49|||ANCOVA||The Shapiro-Wilk normality test of residuals indicated that the data did not have a normal distribution (p-value 0.0108).|"Treatment comparison of change versus placebo. LS mean difference in change. When a subject had no RP attacks in the past 24 hours, the frequency was considered as zero for that day.~The LS means, SEs, CIs, and p-values came from an ANCOVA model with randomized treatment group and use of phosphodiesterase inhibitors at screening (yes, no) as factors and baseline as a covariate."||7.49|-9.04|0.8498
72574470|NCT03867097|144675447|SUPERIORITY||Median Difference (Final Values)|-0.24||||0.9729|TWO_SIDED|95.0|-9.97|9.32|||Wilcoxon (Mann-Whitney)|||"Change in the Weekly Frequency of Symptomatic Raynaud's Phenomenon Attacks From Baseline to the Double-Blind Endpoint Using Nonparametric Analysis - Modified Intent-to-Treat Population.~Treatment comparison of change versus placebo."||9.32|-9.97|0.9729
72574471|NCT01372774|144675448|SUPERIORITY||Hazard Ratio (HR)|0.47|||<|0.0001|TWO_SIDED|95.0|0.35|0.63|||Log Rank|||||0.63|0.35|<0.0001
72627325|NCT01561976|144783644|OTHER||Ratio|116.87||||0.0169|TWO_SIDED|95.0|107.07|127.57|||ANOVA||Ratio= METLEAD ForteSR-Fed/METLEAD ForteSR-Fasting|||127.57|107.07|0.0169
72627326|NCT01561976|144783644|OTHER||Ratio|107.38||||0.0169|TWO_SIDED|95.0|98.3|117.29|||ANOVA||Ratio= METLEAD G2 Forte/METLEAD ForteSR-Fasting|||117.29|98.30|0.0169
72627327|NCT03218917|144783666|SUPERIORITY||||||=|0.014||||||P-value is one-sided for superiority.|Stratified Log-rank test|Stratified by Pseudomonas aeruginosa (Pa) colonization status and maintenance antibiotic use at Baseline.||||||= 0.014
72627328|NCT03218917|144783666|SUPERIORITY||||||=|0.022||||||P-value is one-sided for superiority.|Stratified Log-rank test|Stratified by colonization status and maintenance antibiotic use at Baseline.||||||= 0.022
72409315|NCT02873923|144327147|OTHER||Correlation coefficient|0.66|||||TWO_SIDED|95.0|0.63|0.68|||||||As of today, the meta-analytic surrogacy evaluation scheme proposed by Buyse and Burzykowski et al. is considered as the most statistically rigorous method for the validation of surrogate endpoints. This approach requires individual-patient data (IPD) from multiple randomized clinical trials (RCT) with similar design and treatment to address surrogacy from a multi-level framework. At the patient level, the surrogate endpoint should be correlated and predictive of the final endpoint regardless of the treatment (individual level association). At the trial level, the treatment effect on the surrogate endpoint should be correlated and predictive of the treatment effect on the final endpoint (trial-level association). Individual-level and trial-level associations estimated using weighted linear regression and the two-stage model introduced by Buyse and Burzykowski.|0.68|0.63|
72409316|NCT02873923|144327148|OTHER||correlation coefficient|0.0|||||TWO_SIDED|95.0|0.0|0.005|||||||As of today, the meta-analytic surrogacy evaluation scheme proposed by Buyse and Burzykowski et al. is considered as the most statistically rigorous method for the validation of surrogate endpoints. This approach requires individual-patient data (IPD) from multiple randomized clinical trials (RCT) with similar design and treatment to address surrogacy from a multi-level framework. At the patient level, the surrogate endpoint should be correlated and predictive of the final endpoint regardless of the treatment (individual level association). At the trial level, the treatment effect on the surrogate endpoint should be correlated and predictive of the treatment effect on the final endpoint (trial-level association). Individual-level and trial-level associations estimated using weighted linear regression and the two-stage model introduced by Buyse and Burzykowski.|0.005|0.00|
72409317|NCT01610700|144327154|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-5.93||||0.124||95.0|-13.52|1.65|||ANCOVA|||The change in the primary impairment was compared between treatment groups using analysis of covariance (ANCOVA) with baseline primary impairment score as the covariate.||1.65|-13.52|0.124
72538203|NCT03692078|144605810|EQUIVALENCE|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 5. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|0.338||||0.1638|TWO_SIDED|95.0|-0.138|0.814|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 5. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 5. (mITT Population)||0.814|-0.138|0.1638
72574472|NCT01372774|144675449|SUPERIORITY||Hazard Ratio (HR)|1.07||||0.7|TWO_SIDED|95.0|0.76|1.5|||Log Rank|||||1.50|0.76|0.70
72574473|NCT01372774|144675450|SUPERIORITY|||||||0.00068||||||Intracranial Brain Control Rates estimated via 1-Cumulative Incidence Rate from Competing Risk survival analysis of time to the specific recurrence type. Deaths without recurrence are censored at time of death.|Gray's K-sample|||||||0.00068
72574474|NCT01372774|144675452|SUPERIORITY|||||||0.31|||||||Chi-squared|||||||0.31
72574475|NCT02022748|144675456|OTHER||Ratio of Geometric Least Square Means|151.13|||||TWO_SIDED|90.0|112.03|203.86|||||Treatment H is the reference treatment.|||203.86|112.03|
72574476|NCT02022748|144675456|OTHER||Ratio of Geometric Least Square Means|161.38|||||TWO_SIDED|90.0|122.52|212.58|||||Treatment H is the reference treatment.|||212.58|122.52|
72574477|NCT02022748|144675456|OTHER||Ratio of Geometric Least Square Means|90.1|||||TWO_SIDED|90.0|78.07|103.98|||||A linear mixed model with sequence, period, and treatment as fixed effects, and subject-within-sequence as a random effect, was used to analyze the natural log-transformed values of the PK parameters. Treatment B is the reference treatment.|||103.98|78.07|
72574478|NCT02022748|144675457|OTHER||Ratio of Geometric Least Square Means|117.09|||||TWO_SIDED|90.0|84.51|162.22|||||Treatment H is the reference treatment.|||162.22|84.51|
72574479|NCT02022748|144675457|OTHER||Ratio of Geometric Least Square Means|136.27|||||TWO_SIDED|90.0|95.38|194.7|||||Treatment H is the reference treatment.|||194.70|95.38|
72574480|NCT02022748|144675457|OTHER||Ratio of Geometric Least Square Means|82.29|||||TWO_SIDED|90.0|68.43|98.96|||||A linear mixed model with sequence, period, and treatment as fixed effects, and subject-within-sequence as a random effect, was used to analyze the natural log-transformed values of the PK parameters. Treatment B is the reference treatment.|||98.96|68.43|
72574481|NCT02022748|144675458|OTHER||Ratio of Geometric Least Square Means|137.75|||||TWO_SIDED|90.0|105.7|179.52|||||Treatment H is the reference treatment.|||179.52|105.70|
72574482|NCT02022748|144675458|OTHER||Ratio of Geometric Least Square Means|148.76|||||TWO_SIDED|90.0|115.07|192.32|||||Treatment H is the reference treatment.|||192.32|115.07|
72574483|NCT02022748|144675458|OTHER||Ratio of Geometric Least Square Means|90.35|||||TWO_SIDED|90.0|77.55|105.27|||||A linear mixed model with sequence, period, and treatment as fixed effects, and subject-within-sequence as a random effect, was used to analyze the natural log-transformed values of the PK parameters. Treatment B is the reference treatment.|||105.27|77.55|
72574484|NCT02022748|144675459|OTHER||Ratio of Geometric Least Square Means|112.73|||||TWO_SIDED|90.0|88.61|143.42|||||Treatment H is the reference treatment.|||143.42|88.61|
72574485|NCT02022748|144675459|OTHER||Ratio of Geometric Least Square Means|114.37|||||TWO_SIDED|90.0|91.19|143.45|||||Treatment H is the reference treatment.|||143.45|91.19|
72574486|NCT02022748|144675459|OTHER||Ratio of Geometric Least Square Means|93.13|||||TWO_SIDED|90.0|80.31|108.0|||||A linear mixed model with sequence, period, and treatment as fixed effects, and subject-within-sequence as a random effect, was used to analyze the natural log-transformed values of the PK parameters. Treatment B is the reference treatment.|||108.00|80.31|
72574487|NCT02022748|144675460|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.11|||||TWO_SIDED|90.0|-0.97|0.75|||||Treatment A - Treatment H.|||0.75|-0.97|
72574488|NCT02022748|144675460|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.28|||||TWO_SIDED|90.0|-0.96|1.52|||||Treatment B - Treatment H.|||1.52|-0.96|
72574489|NCT02022748|144675460|SUPERIORITY_OR_OTHER||Difference of Least Square Means|-0.36|||||TWO_SIDED|90.0|-1.73|1.02|||||A linear mixed model with sequence, period, and treatment as fixed effects, and subject-within-sequence as a random effect, was used to analyze the natural log-transformed values of the PK parameters. Treatment A - Treatment B.|||1.02|-1.73|
72409318|NCT01610700|144327155|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-7.1||||0.062|TWO_SIDED|95.0|-14.56|0.37|||ANCOVA|||The change in the spasticity visual analogue scale score was compared between treatment groups using ANCOVA with baseline primary impairment score as the covariate.||0.37|-14.56|0.062
72409319|NCT01610700|144327156|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-1.88||||0.731|TWO_SIDED|95.0|-12.73|8.96|||ANCOVA|||The change in the pain visual analogue scale score was compared between treatment groups using ANCOVA with baseline primary impairment score as the covariate.||8.96|-12.73|0.731
72409320|NCT01610700|144327157|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-3.3||||0.443|TWO_SIDED|95.0|-11.82|5.21|||ANCOVA|||The change in the muscle spasm visual analogue scale score was compared between treatment groups using ANCOVA with baseline primary impairment score as the covariate.||5.21|-11.82|0.443
72409321|NCT01610700|144327158|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-6.85||||0.311|TWO_SIDED|95.0|-20.31|6.6|||ANCOVA|||The change in the tremor visual analogue scale score was compared between treatment groups using ANCOVA with baseline primary impairment score as the covariate.||6.60|-20.31|0.311
72409322|NCT01610700|144327159|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-6.26|STANDARD_ERROR_OF_MEAN|4.36||0.154|TWO_SIDED|95.0|-14.9|2.38|||ANCOVA|||The change in bladder problems visual analogue scale score was compared between treatment groups using ANCOVA with baseline primary impairment score as the covariate.||2.38|-14.90|0.154
72409323|NCT01610700|144327160|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.36||||0.293|TWO_SIDED|95.0|0.77|2.43|||Fisher Exact|||The proportion of subjects with better/much better assessments was compared between groups using a Fisher's Exact Test.||2.43|0.77|0.293
72538204|NCT03692078|144605810|EQUIVALENCE|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 7. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|-0.05||||0.8384|TWO_SIDED|95.0|-0.533|0.433|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 7. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 7. (mITT Population)||0.433|-0.533|0.8384
72538205|NCT03692078|144605810|EQUIVALENCE|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 5. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-0.086||||1|TWO_SIDED|95.0|-0.869|0.698|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 5. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 5. (mITT Population)||0.698|-0.869|1.0000
72538206|NCT03692078|144605810|EQUIVALENCE|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 7. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-0.581||||0.2808|TWO_SIDED|95.0|-1.377|0.214|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 7. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 7. (mITT Population)||0.214|-1.377|0.2808
72538207|NCT03692078|144605810|EQUIVALENCE|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 5. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-0.095||||1|TWO_SIDED|95.0|-0.887|0.698|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 5. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 5. (mITT Population)||0.698|-0.887|1.0000
72538208|NCT03692078|144605810|EQUIVALENCE|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 7. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-0.444||||0.6018|TWO_SIDED|95.0|-1.237|0.349|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 7. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 7. (mITT Population)||0.349|-1.237|0.6018
72574490|NCT02022748|144675461|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.07|||||TWO_SIDED|90.0|-2.62|0.48|||||Treatment A - Treatment H.|||0.48|-2.62|
72574491|NCT02022748|144675461|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.05|||||TWO_SIDED|90.0|-2.46|0.37|||||Treatment B - Treatment H.|||0.37|-2.46|
72409324|NCT01610700|144327162|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|0.69||||0.45|TWO_SIDED|95.0|-1.11|2.5|||ANCOVA|||The change from baseline in the mean Beck's Depression Inventory score at the end of treatment was compared between treatment groups using ANCOVA with baseline primary impairment score as the covariate.||2.50|-1.11|0.450
72409325|NCT01610700|144327163|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-0.12||||0.427|TWO_SIDED|95.0|-0.43|0.18|||ANCOVA|||The change baseline in the mean Fatigue Severity Scale Questionnaire score at the end of treatment was compared between treatment groups using ANCOVA with baseline primary impairment score as the covariate.||0.18|-0.43|0.427
72409326|NCT01610700|144327165|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|0.72||||0.647|TWO_SIDED|95.0|-2.38|3.82|||ANCOVA|||The change from baseline in the mean total 28-item General Health Questionnaire score at the end of treatment was compared between treatment groups using ANCOVA with baseline primary impairment score as the covariate.||3.82|-2.38|0.647
72409327|NCT01610700|144327167|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-0.12|STANDARD_ERROR_OF_MEAN|0.83||0.889|TWO_SIDED|95.0|-1.77|1.54|||ANCOVA|||The change from baseline in the mean total bladder control test score at the end of treatment was compared between treatment groups using ANCOVA with baseline primary impairment score as the covariate.||1.54|-1.77|0.889
72409328|NCT01610700|144327170|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-7.1||||0.047|TWO_SIDED|95.0|-14.11|-0.08|||ANCOVA|||The from baseline in the mean sleep quality 100 mm visual analogue scale score at the end of treatment was compared between treatment groups using ANCOVA with baseline primary impairment score as the covariate.||-0.08|-14.11|0.047
72538209|NCT03692078|144605810|EQUIVALENCE|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 5. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-0.645||||0.2935|TWO_SIDED|95.0|-1.536|0.246|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 5. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 5. (mITT Population)||0.246|-1.536|0.2935
72538210|NCT03692078|144605810|EQUIVALENCE|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 7. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-1.218||||0.0023|TWO_SIDED|95.0|-2.12|-0.315|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 7. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 7. (mITT Population)||-0.315|-2.120|0.0023
72538211|NCT03692078|144605810|EQUIVALENCE|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 5. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-0.844||||0.0669|TWO_SIDED|95.0|-1.723|0.035|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 5. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 5. (mITT Population)||0.035|-1.723|0.0669
72538212|NCT03692078|144605810|EQUIVALENCE|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 7. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-1.539|||<|0.0001|TWO_SIDED|95.0|-2.438|-0.64|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 7. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 7. (mITT Population)||-0.640|-2.438|<.0001
72538213|NCT03692078|144605810|EQUIVALENCE|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 5. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|0.658||||0.212|TWO_SIDED|95.0|-0.192|1.509|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 5. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 5. (mITT Population)||1.509|-0.192|0.2120
72574492|NCT02022748|144675461|SUPERIORITY_OR_OTHER||Difference of Least Square Means|-0.5|||||TWO_SIDED|90.0|-1.27|0.27|||||A linear mixed model with sequence, period, and treatment as fixed effects, and subject-within-sequence as a random effect, was used to analyze the natural log-transformed values of the PK parameters. Treatment A - Treatment B.|||0.27|-1.27|
72574493|NCT03954834|144675469|SUPERIORITY||LS Mean Difference|-1.91|||<|0.001|TWO_SIDED|95.0|-2.18|-1.63|||Mixed Models Analysis|||||-1.63|-2.18|<0.001
72574494|NCT03954834|144675469|SUPERIORITY||LS Mean Difference|-1.93|||<|0.001|TWO_SIDED|95.0|-2.21|-1.65|||Mixed Models Analysis|||||-1.65|-2.21|<0.001
72574495|NCT03954834|144675469|SUPERIORITY||LS Mean Difference|-2.11|||<|0.001|TWO_SIDED|95.0|-2.39|-1.83|||Mixed Models Analysis|||||-1.83|-2.39|<0.001
72574496|NCT03954834|144675470|SUPERIORITY||LS Mean Difference|-6.3|||<|0.001|TWO_SIDED|95.0|-7.8|-4.7|||Mixed Models Analysis|||||-4.7|-7.8|<0.001
72574497|NCT03954834|144675470|SUPERIORITY||LS Mean Difference|-7.1|||<|0.001|TWO_SIDED|95.0|-8.6|-5.5|||Mixed Models Analysis|||||-5.5|-8.6|<0.001
72574498|NCT03954834|144675470|SUPERIORITY||LS Mean Difference|-8.8|||<|0.001|TWO_SIDED|95.0|-10.3|-7.2|||Mixed Models Analysis|||||-7.2|-10.3|<0.001
72574499|NCT03954834|144675471|SUPERIORITY||Odds Ratio (OR)|49.0|||<|0.001|TWO_SIDED|95.0|21.12|113.67|||Regression, Logistic|||||113.67|21.12|<0.001
72574500|NCT03954834|144675471|SUPERIORITY||Odds Ratio (OR)|80.39|||<|0.001|TWO_SIDED|95.0|31.8|203.19|||Regression, Logistic|||||203.19|31.80|<0.001
72574501|NCT03954834|144675471|SUPERIORITY||Odds Ratio (OR)|52.95|||<|0.001|TWO_SIDED|95.0|22.3|125.73|||Regression, Logistic|||||125.73|22.30|<0.001
72574502|NCT03954834|144675472|SUPERIORITY||LS Mean Difference|-1.5||||0.776|TWO_SIDED|95.0|-11.9|8.9|||Mixed Models Analysis|||||8.9|-11.9|0.776
72574503|NCT03954834|144675472|SUPERIORITY||LS Mean Difference|-2.6||||0.622|TWO_SIDED|95.0|-13.0|7.8|||Mixed Models Analysis|||||7.8|-13.0|0.622
72409329|NCT01610700|144327171|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-4.53||||0.198|TWO_SIDED|95.0|-11.45|2.4|||ANCOVA|||The change from baseline in the mean sleep amount 100 mm visual analogue scale score at the end of treatment was compared between treatment groups using ANCOVA with baseline primary impairment score as the covariate.||2.40|-11.45|0.198
72409330|NCT01610700|144327172|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-1.36||||0.717|TWO_SIDED|95.0|-8.8|6.07|||ANCOVA|||The from baseline in the mean feeling upon wakening 100 mm visual analogue scale score at the end of treatment was compared between treatment groups using ANCOVA with baseline primary impairment score as the covariate.||6.07|-8.80|0.717
72574504|NCT03954834|144675472|SUPERIORITY||LS Mean Difference|-0.6||||0.908|TWO_SIDED|95.0|-11.1|9.8|||Mixed Models Analysis|||||9.8|-11.1|0.908
72538214|NCT03692078|144605810|EQUIVALENCE|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 7. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|0.778||||0.0993|TWO_SIDED|95.0|-0.087|1.642|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 7. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 7. (mITT Population)||1.642|-0.087|0.0993
72538215|NCT03692078|144605810|EQUIVALENCE|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 5. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|0.649||||0.2347|TWO_SIDED|95.0|-0.211|1.509|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 5. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 5. (mITT Population)||1.509|-0.211|0.2347
72538216|NCT03692078|144605810|EQUIVALENCE|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 7. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|0.915||||0.032|TWO_SIDED|95.0|0.052|1.778|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 7. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 7. (mITT Population)||1.778|0.052|0.0320
72538217|NCT03692078|144605810|EQUIVALENCE|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 5. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|0.099||||1|TWO_SIDED|95.0|-0.849|1.047|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 5. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 5. (mITT Population)||1.047|-0.849|1.0000
72538218|NCT03692078|144605810|EQUIVALENCE|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 7. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|0.141||||0.9999|TWO_SIDED|95.0|-0.82|1.103|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 7. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 7. (mITT Population)||1.103|-0.820|0.9999
72538219|NCT03692078|144605810|EQUIVALENCE|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 5. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|-0.101||||1|TWO_SIDED|95.0|-1.038|0.837|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 5. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 5. (mITT Population)||0.837|-1.038|1.0000
72538220|NCT03692078|144605810|EQUIVALENCE|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 7. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|-0.18||||0.9995|TWO_SIDED|95.0|-1.139|0.779|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 7. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 7. (mITT Population)||0.779|-1.139|0.9995
72538221|NCT03692078|144605812|EQUIVALENCE|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 5. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|3.12|||<|0.0001|TWO_SIDED|95.0|2.964|3.276|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 5. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 5. (mITT Population)||3.276|2.964|<.0001
72538222|NCT03692078|144605812|EQUIVALENCE|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 7. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|3.141|||<|0.0001|TWO_SIDED|95.0|2.953|3.328|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 7. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 7. (mITT Population)||3.328|2.953|<.0001
72574505|NCT03954834|144675473|SUPERIORITY||Odds Ratio (OR)|40.28|||<|0.001|TWO_SIDED|95.0|7.74|209.71|||Regression, Logistic|||||209.71|7.74|<0.001
72574506|NCT03954834|144675473|SUPERIORITY||Odds Ratio (OR)|34.12|||<|0.001|TWO_SIDED|95.0|6.53|178.19|||Regression, Logistic|||||178.19|6.53|<0.001
72409331|NCT01610700|144327173|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-0.47||||0.087|TWO_SIDED|95.0|-1.01|0.07|||ANCOVA|||The change from baseline in the mean Barthel Activities for Daily Living scale score at the end of treatment was compared between treatment groups using ANCOVA with baseline primary impairment score as the covariate.||0.07|-1.01|0.087
72409332|NCT01610700|144327177|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|1.81||||0.048|TWO_SIDED|95.0|0.02|3.6|||ANCOVA|||The change from baseline in the mean Guy's Neurological Disability Scale score at the end of treatment was compared between treatment groups using ANCOVA with baseline primary impairment score as the covariate.||3.60|0.02|0.048
72409333|NCT01610700|144327178|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-0.11||||0.904|TWO_SIDED|95.0|-1.85|1.64|||ANCOVA|||The change from baseline in the mean Atkinson Morley Information Processing Battery test score at the end of treatment was compared between treatment groups using ANCOVA with baseline primary impairment score as the covariate.||1.64|-1.85|0.904
72538223|NCT03692078|144605812|EQUIVALENCE|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 5. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|2.658|||<|0.0001|TWO_SIDED|95.0|2.511|2.806|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 5. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 5. (mITT Population)||2.806|2.511|<.0001
72538224|NCT03692078|144605812|EQUIVALENCE|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 7. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|2.638|||<|0.0001|TWO_SIDED|95.0|2.458|2.817|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 7. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 7. (mITT Population)||2.817|2.458|<.0001
72538225|NCT03692078|144605812|EQUIVALENCE|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 5. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|2.754|||<|0.0001|TWO_SIDED|95.0|2.604|2.903|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 5. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 5. (mITT Population)||2.903|2.604|<.0001
72574507|NCT03954834|144675473|SUPERIORITY||Odds Ratio (OR)|85.13|||<|0.001|TWO_SIDED|95.0|16.36|443.13|||Regression, Logistic|||||443.13|16.36|<0.001
72574508|NCT03954834|144675474|SUPERIORITY||LS Mean Difference|-37.7|||<|0.001|TWO_SIDED|95.0|-44.1|-31.2|||Mixed Models Analysis|||Morning Premeal - Fasting||-31.2|-44.1|<0.001
72574509|NCT03954834|144675474|SUPERIORITY||LS Mean Difference|-38.6|||<|0.001|TWO_SIDED|95.0|-45.1|-32.2|||Mixed Models Analysis|||Morning Premeal - Fasting||-32.2|-45.1|<0.001
72574510|NCT03954834|144675474|SUPERIORITY||LS Mean Difference|-36.5|||<|0.001|TWO_SIDED|95.0|-43.1|-29.8|||Mixed Models Analysis|||Morning Premeal - Fasting||-29.8|-43.1|<0.001
72574511|NCT03954834|144675474|SUPERIORITY||LS Mean Difference|-57.9|||<|0.001|TWO_SIDED|95.0|-68.4|-47.4|||Mixed Models Analysis|||Morning 2-hour Postmeal||-47.4|-68.4|<0.001
72574512|NCT03954834|144675474|SUPERIORITY||LS Mean Difference|-49.7|||<|0.001|TWO_SIDED|95.0|-60.3|-39.2|||Mixed Models Analysis|||Morning 2-hour Postmeal||-39.2|-60.3|<0.001
72574513|NCT03954834|144675474|SUPERIORITY||LS Mean Difference|-57.3|||<|0.001|TWO_SIDED|95.0|-68.1|-46.4|||Mixed Models Analysis|||Morning 2-hour Postmeal||-46.4|-68.1|<0.001
72574514|NCT03954834|144675474|SUPERIORITY||LS Mean Difference|-40.9|||<|0.001|TWO_SIDED|95.0|-49.6|-32.2|||Mixed Models Analysis|||Midday Premeal||-32.2|-49.6|<0.001
72574515|NCT03954834|144675474|SUPERIORITY||LS Mean Difference|-39.9|||<|0.001|TWO_SIDED|95.0|-48.6|-31.2|||Mixed Models Analysis|||Midday Premeal||-31.2|-48.6|<0.001
72409334|NCT02391948|144327199|OTHER||mean population value age 12|98.3|||||TWO_SIDED|95.0|97.8|98.6||||||||98.6|97.8|
72409335|NCT02391948|144327199|OTHER||mean population value age 12|89.1|||||TWO_SIDED|95.0|86.6|91.1||||||||91.1|86.6|
72409336|NCT02391948|144327199|OTHER||mean population value age 12|50.1|||||TWO_SIDED|95.0|46.5|53.6||||||||53.6|46.5|
72409337|NCT02391948|144327199|OTHER||mean population value age 12|25.3|||||TWO_SIDED|95.0|23.7|27.0||||||||27.0|23.7|
72409338|NCT02391948|144327199|OTHER||mean population value age 12|6.48|||||TWO_SIDED|95.0|5.66|7.38||||||||7.38|5.66|
72409339|NCT02391948|144327200|OTHER||mean population value age 12|0.44|||||TWO_SIDED|95.0|0.38|0.49||||||||0.49|0.38|
72409340|NCT02391948|144327200|OTHER||mean population value age 12|0.68|||||TWO_SIDED|95.0|0.6|0.77||||||||0.77|0.60|
72409341|NCT02391948|144327200|OTHER||mean population value age 12|0.93|||||TWO_SIDED|95.0|0.79|1.07||||||||1.07|0.79|
72409342|NCT02391948|144327200|OTHER||mean population value age 12|1.38|||||TWO_SIDED|95.0|1.22|1.54||||||||1.54|1.22|
72409343|NCT02391948|144327200|OTHER||mean population value age 12|2.16|||||TWO_SIDED|95.0|2.01|2.31||||||||2.31|2.01|
72409344|NCT02391948|144327201|OTHER||mean population value|4.49|||||TWO_SIDED|95.0|4.43|4.54||||||||4.54|4.43|
72409345|NCT02391948|144327201|OTHER||mean population value|4.1|||||TWO_SIDED|95.0|3.99|4.2||||||||4.20|3.99|
72409346|NCT02391948|144327201|OTHER||mean population value|3.99|||||TWO_SIDED|95.0|3.75|4.25||||||||4.25|3.75|
72409347|NCT02391948|144327201|OTHER||mean population value|2.95|||||TWO_SIDED|95.0|2.73|3.19||||||||3.19|2.73|
72409348|NCT02391948|144327201|OTHER||mean population value|1.59|||||TWO_SIDED|95.0|1.44|1.75||||||||1.75|1.44|
72409349|NCT02391948|144327202|OTHER||mean population value|1362.3|||||TWO_SIDED|95.0|1313.6|1410.7||||||||1410.7|1313.6|
72574516|NCT03954834|144675474|SUPERIORITY||LS Mean Difference|-40.0|||<|0.001|TWO_SIDED|95.0|-49.0|-31.1|||Mixed Models Analysis|||Midday Premeal||-31.1|-49.0|<0.001
72538226|NCT03692078|144605812|EQUIVALENCE|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 7. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|2.652|||<|0.0001|TWO_SIDED|95.0|2.471|2.832|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 7. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 7. (mITT Population)||2.832|2.471|<.0001
72538227|NCT03692078|144605812|EQUIVALENCE|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 5. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|1.703|||<|0.0001|TWO_SIDED|95.0|1.517|1.889|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 5. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 5. (mITT Population)||1.889|1.517|<.0001
72538228|NCT03692078|144605812|EQUIVALENCE|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 7. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|1.637|||<|0.0001|TWO_SIDED|95.0|1.41|1.865|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 7. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 7. (mITT Population)||1.865|1.410|<.0001
72538229|NCT03692078|144605812|EQUIVALENCE|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 5. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|1.656|||<|0.0001|TWO_SIDED|95.0|1.472|1.839|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 5. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 5. (mITT Population)||1.839|1.472|<.0001
72538230|NCT03692078|144605812|EQUIVALENCE|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 7. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|1.485|||<|0.0001|TWO_SIDED|95.0|1.259|1.711|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 7. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 7. (mITT Population)||1.711|1.259|<.0001
72538231|NCT03692078|144605812|EQUIVALENCE|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 5. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|1.713|||<|0.0001|TWO_SIDED|95.0|1.532|1.895|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 5. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 5. (mITT Population)||1.895|1.532|<.0001
72538232|NCT03692078|144605812|EQUIVALENCE|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 7. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|1.617|||<|0.0001|TWO_SIDED|95.0|1.397|1.837|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 7. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 7. (mITT Population)||1.837|1.397|<.0001
72538233|NCT03692078|144605812|EQUIVALENCE|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 5. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-0.462||||0.0003|TWO_SIDED|95.0|-0.766|-0.158|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 5. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 5. (mITT Population)||-0.158|-0.766|0.0003
72574517|NCT03954834|144675474|SUPERIORITY||LS Mean Difference|-51.4|||<|0.001|TWO_SIDED|95.0|-62.5|-40.4|||Mixed Models Analysis|||Midday 2-hour Postmeal||-40.4|-62.5|<0.001
72574518|NCT03954834|144675474|SUPERIORITY||LS Mean Difference|-47.3|||<|0.001|TWO_SIDED|95.0|-58.4|-36.2|||Mixed Models Analysis|||Midday 2-hour Postmeal||-36.2|-58.4|<0.001
72574519|NCT03954834|144675474|SUPERIORITY||LS Mean Difference|-50.7|||<|0.001|TWO_SIDED|95.0|-62.1|-39.3|||Mixed Models Analysis|||Midday 2-hour Postmeal||-39.3|-62.1|<0.001
72409350|NCT02391948|144327202|OTHER||mean population value|1096.33|||||TWO_SIDED|95.0|1028.8|1158.62||||||||1158.62|1028.80|
72409351|NCT02391948|144327202|OTHER||mean population value|592.62|||||TWO_SIDED|95.0|533.79|652.72||||||||652.72|533.79|
72409352|NCT02391948|144327203|OTHER||mean population value|3.99|||||TWO_SIDED|95.0|3.91|4.07||||||||4.07|3.91|
72409353|NCT02391948|144327203|OTHER||mean population value|3.49|||||TWO_SIDED|95.0|3.39|3.6||||||||3.60|3.39|
72409354|NCT02391948|144327203|OTHER||mean population value|3.23|||||TWO_SIDED|95.0|3.08|3.37||||||||3.37|3.08|
72409355|NCT02391948|144327203|OTHER||mean population value|2.8|||||TWO_SIDED|95.0|2.67|2.93||||||||2.93|2.67|
72538234|NCT03692078|144605812|EQUIVALENCE|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 7. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-0.503||||0.0018|TWO_SIDED|95.0|-0.867|-0.139|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 7. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 7. (mITT Population)||-0.139|-0.867|0.0018
72538235|NCT03692078|144605812|EQUIVALENCE|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 5. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-0.366||||0.0089|TWO_SIDED|95.0|-0.67|-0.062|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 5. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 5. (mITT Population)||-0.062|-0.670|0.0089
72538236|NCT03692078|144605812|EQUIVALENCE|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 7. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-0.489||||0.0025|TWO_SIDED|95.0|-0.851|-0.126|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 7. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 7. (mITT Population)||-0.126|-0.851|0.0025
72574520|NCT03954834|144675474|SUPERIORITY||LS Mean Difference|-39.0|||<|0.001|TWO_SIDED|95.0|-47.6|-30.4|||Mixed Models Analysis|||Evening Premeal||-30.4|-47.6|<0.001
72574521|NCT03954834|144675474|SUPERIORITY||LS Mean Difference|-39.2|||<|0.001|TWO_SIDED|95.0|-47.9|-30.6|||Mixed Models Analysis|||Evening Premeal||-30.6|-47.9|<0.001
72574522|NCT03954834|144675474|SUPERIORITY||LS Mean Difference|-36.4|||<|0.001|TWO_SIDED|95.0|-45.3|-27.5|||Mixed Models Analysis|||Evening Premeal||-27.5|-45.3|<0.001
72574523|NCT03954834|144675474|SUPERIORITY||LS Mean Difference|-51.7|||<|0.001|TWO_SIDED|95.0|-63.2|-40.1|||Mixed Models Analysis|||Evening 2-hour Postmeal||-40.1|-63.2|<0.001
72574524|NCT03954834|144675474|SUPERIORITY||LS Mean Difference|-52.5|||<|0.001|TWO_SIDED|95.0|-64.1|-40.9|||Mixed Models Analysis|||Evening 2-hour Postmeal||-40.9|-64.1|<0.001
72574525|NCT03954834|144675474|SUPERIORITY||LS Mean Difference|-53.2|||<|0.001|TWO_SIDED|95.0|-65.1|-41.3|||Mixed Models Analysis|||Evening 2-hour Postmeal||-41.3|-65.1|<0.001
72574526|NCT03954834|144675474|SUPERIORITY||LS Mean Difference|-48.0|||<|0.001|TWO_SIDED|95.0|-58.6|-37.4|||Mixed Models Analysis|||Bedtime||-37.4|-58.6|<0.001
72574527|NCT03954834|144675474|SUPERIORITY||LS Mean Difference|-50.7|||<|0.001|TWO_SIDED|95.0|-61.3|-40.1|||Mixed Models Analysis|||Bedtime||-40.1|-61.3|<0.001
72574528|NCT03954834|144675474|SUPERIORITY||LS Mean Difference|-51.7|||<|0.001|TWO_SIDED|95.0|-62.6|-40.9|||Mixed Models Analysis|||||-40.9|-62.6|<0.001
72574529|NCT03954834|144675475|SUPERIORITY||Odds Ratio (OR)|12.4|||<|0.001|TWO_SIDED|95.0|6.43|23.94|||Regression, Logistic|||||23.94|6.43|<0.001
72574530|NCT03954834|144675475|SUPERIORITY||Odds Ratio (OR)|21.13|||<|0.001|TWO_SIDED|95.0|10.59|42.18|||Regression, Logistic|||||42.18|10.59|<0.001
72409356|NCT02391948|144327203|OTHER||mean population value|1.79|||||TWO_SIDED|95.0|1.67|1.91||||||||1.91|1.67|
72409357|NCT02391948|144327204|OTHER||mean population value|0.59|||||TWO_SIDED|9.0|0.47|0.72||||||||0.72|0.47|
72409358|NCT02391948|144327204|OTHER||mean population value|1.1|||||TWO_SIDED|95.0|0.91|1.3||||||||1.30|0.91|
72409359|NCT02391948|144327204|OTHER||mean population value|0.68|||||TWO_SIDED|95.0|0.48|0.89||||||||0.89|0.48|
72409360|NCT02391948|144327204|OTHER||mean population value|1.38|||||TWO_SIDED|95.0|1.12|1.65||||||||1.65|1.12|
72409361|NCT02391948|144327204|OTHER||mean population value|2.33|||||TWO_SIDED|95.0|2.08|2.6||||||||2.60|2.08|
72409362|NCT02391948|144327205|OTHER||mean population value age 12|70.6|||||TWO_SIDED|95.0|69.1|72.0||||||||72.0|69.1|
72409363|NCT02391948|144327205|OTHER||mean population value age 12|62.1|||||TWO_SIDED|95.0|59.4|65.0||||||||65.0|59.4|
72409364|NCT02391948|144327205|OTHER||mean population value age 12|62.9|||||TWO_SIDED|95.0|60.9|65.0||||||||65.0|60.9|
72409365|NCT02391948|144327205|OTHER||mean population value age 12|58.2|||||TWO_SIDED|95.0|56.7|59.7||||||||59.7|56.7|
72409366|NCT02391948|144327205|OTHER||mean population value age 12|51.9|||||TWO_SIDED|95.0|50.2|53.6||||||||53.6|50.2|
72409367|NCT02391948|144327206|OTHER||mean population value age 12|78.3|||||TWO_SIDED|95.0|76.0|80.4||||||||80.4|76.0|
72409368|NCT02391948|144327206|OTHER||mean population value age 12|66.1|||||TWO_SIDED|95.0|63.5|68.5||||||||68.5|63.5|
72409369|NCT02391948|144327206|OTHER||mean population value age 12|60.5|||||TWO_SIDED|95.0|57.3|63.3|||mean population value age 12|||||63.3|57.3|
72409370|NCT02391948|144327206|OTHER||mean population value age 12|37.9|||||TWO_SIDED|95.0|35.6|40.3||||||||40.3|35.6|
72409371|NCT02391948|144327206|OTHER||mean population value age 12|14.5|||||TWO_SIDED|95.0|12.4|16.5||||||||16.5|12.4|
72409372|NCT02391948|144327207|OTHER||Odds Ratio (OR)|1.46|||||TWO_SIDED|95.0|1.06|2.02|||||Data from all GMFCS levels was used, country was included as a model covariate. OR represents the odds of children developing 'better than expected' (top 10%) vs 'as expected' (central 80%) for each unit change in family-centredness outcome.|Logistic regression comparing children progressing better than expected to those progressing as expected on the Child Engagement in Daily Life - Participation outcome for the predictor family-centred service.||2.02|1.06|
72574531|NCT03954834|144675475|SUPERIORITY||Odds Ratio (OR)|20.1|||<|0.001|TWO_SIDED|95.0|10.09|40.04|||Regression, Logistic|||||40.04|10.09|<0.001
72538237|NCT03692078|144605812|EQUIVALENCE|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 5. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-1.417|||<|0.0001|TWO_SIDED|95.0|-1.762|-1.072|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 5. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 5. (mITT Population)||-1.072|-1.762|<.0001
72538238|NCT03692078|144605812|EQUIVALENCE|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 7. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-1.504|||<|0.0001|TWO_SIDED|95.0|-1.916|-1.091|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 7. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 7. (mITT Population)||-1.091|-1.916|<.0001
72538239|NCT03692078|144605812|EQUIVALENCE|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 5. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-1.464|||<|0.0001|TWO_SIDED|95.0|-1.804|-1.125|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 5. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 5. (mITT Population)||-1.125|-1.804|<.0001
72538240|NCT03692078|144605812|EQUIVALENCE|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 7. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-1.656|||<|0.0001|TWO_SIDED|95.0|-2.065|-1.247|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 7. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 7. (mITT Population)||-1.247|-2.065|<.0001
72538241|NCT03692078|144605812|EQUIVALENCE|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 5. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|0.945|||<|0.0001|TWO_SIDED|95.0|0.617|1.273|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 5. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 5. (mITT Population)||1.273|0.617|<.0001
72538242|NCT03692078|144605812|EQUIVALENCE|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 7. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|1.021|||<|0.0001|TWO_SIDED|95.0|0.628|1.413|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 7. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 7. (mITT Population)||1.413|0.628|<.0001
72538243|NCT03692078|144605812|EQUIVALENCE|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 5. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|1.041|||<|0.0001|TWO_SIDED|95.0|0.712|1.369|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 5. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 5. (mITT Population)||1.369|0.712|<.0001
72574532|NCT04086407|144675484|OTHER||||||<|0.05|||||||t-test, 2 sided||||All statistical tests were completed with a significance of p \< 0.05 and 95% confidence intervals. Sample sets were statistically compared and analyzed by using two-tailed, unpaired Student t test analyses of means.|||<.05
72574533|NCT04086407|144675485|OTHER||||||<|0.05|||||||t-test, 2 sided||||All statistical tests were completed with a significance of p \< 0.05 and 95% confidence intervals. Sample sets were statistically compared and analyzed by using two-tailed, unpaired Student t test analyses of means.|||<.05
72574534|NCT04086407|144675486|OTHER||||||||||||||||||All statistical tests were completed with a significance of p \< 0.05 and 95% confidence intervals. Sample sets were statistically compared and analyzed by using two-tailed, unpaired Student t test analyses of means.|||
72574535|NCT04086407|144675487|OTHER||||||<|0.05|||||||t-test, 2 sided||||All statistical tests were completed with a significance of p \< 0.05 and 95% confidence intervals. Sample sets were statistically compared and analyzed by using two-tailed, unpaired Student t test analyses of means.|||<.05
72574536|NCT01555671|144675488|OTHER||Mean Difference (Net)|30.0||||0.029|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.029
72576798|NCT00261443|144680653|SUPERIORITY_OR_OTHER_LEGACY||Difference|-1.62||||0.046|TWO_SIDED|95.0|-3.21|-0.03||Baseline: ANOVA model, controlling for treatment, mood stabilizer, and index mood episode. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 32 Comparison||-0.03|-3.21|0.046
72627329|NCT00427193|144783671|OTHER||difference in mean change|0.02|STANDARD_DEVIATION|0.02||0.7|TWO_SIDED|95.0|-0.019|0.059||Type I error was controlled using a hierarchical gatekeeping strategy.|Mixed Models Analysis|||All analysis under intention-to-treat. All observations were included The primary analytic was a repeated measures analysis. The dependent variable was the change from baseline 12 \& 14mos., with treatment, time, and the treatment × time interaction as independent variables. Site, sex, BMI stratum, and the baseline value of the outcome were included as covariates. The predicted mean changes ± standard errors are the adjusted values from the contrasts of the multiple timepoints.||0.059|-0.019|0.70
72627330|NCT00427193|144783672|OTHER||Mean Difference (Net)|0.03|STANDARD_ERROR_OF_MEAN|0.02||0.84|TWO_SIDED|95.0|-0.0092|0.069|||Mixed Models Analysis|||||0.069|-0.0092|0.84
72627331|NCT00427193|144783673|OTHER||Mean Difference (Net)|-82.0|STANDARD_ERROR_OF_MEAN|11.12|<|0.001|TWO_SIDED|95.0|-103.8|-60.2|||Mixed Models Analysis|||||-60.2|-103.8|<0.001
72627332|NCT00427193|144783674|OTHER||Mean Difference (Final Values)|-64.0|STANDARD_DEVIATION|13.5|<|0.0001|TWO_SIDED|95.0|-90.5|-37.5|||Mixed Models Analysis|||||-37.5|-90.5|<0.0001
72627333|NCT00427193|144783675|OTHER||Mean Difference (Net)|0.04|STANDARD_ERROR_OF_MEAN|0.1||0.82|TWO_SIDED|95.0|-0.16|0.23|||Mixed Models Analysis|||||0.23|-0.16|0.82
72627334|NCT00427193|144783676|OTHER||Mean Difference (Net)|-5.9|STANDARD_ERROR_OF_MEAN|0.31|<|0.001|TWO_SIDED|95.0|-6.5|-5.3|||Mixed Models Analysis|||Difference in change in Fat Mass between prescribed 25% Caloric Restriction (CR) and Ad Libitum (AL) at 12 and 24 months as measured by dual X-ray absorptiometry (DXA) using the Hologic 4500A, Delphi W or Discovery A, by a standardized protocol according to a standardized protocol. Fat Mass (FM) and Fat Free Mass (FFM) were determined for the whole body.||-5.3|-6.5|<0.001
72627335|NCT00427193|144783677|OTHER||Mean Difference (Net)|-5.9|STANDARD_ERROR_OF_MEAN|0.26|<|0.0001|TWO_SIDED|95.0|-6.4|-5.3|||Mixed Models Analysis|||Comparison of change in FM in 2 groups over at 24 mos, controlling for site, sex, BMI group, and baseline FM. A repeated measures Mixed Model was employed for the analysis. For any outcome, Type I error was controlled using a hierarchical gatekeeping strategy testing, first, the GroupXTime interaction, and, if non-significant, the main effects of these two factors. Bonferroni corrections were employed for non-significant effects. All tests were at p\<0.05||-5.3|-6.4|<0.0001
72627336|NCT05136170|144783678|SUPERIORITY|The following null hypothesis was defined on this endpoint: the proportion of patients reaching a value of Schirmer I test (without anaesthesia) \>10mm/5min at week 4 in cenegermin (rhNGF) was lower or equal than control. The null hypothesis was rejected if the associated primary analysis p-value was lower than 0.025.|Odds Ratio (OR)|8.498||||0.002|TWO_SIDED|95.0|2.165|33.356||P-value of treatment variable from logistic regression model on proportion of patients reaching a value of Schirmer I test (without anesthesia) \>10mm/5min|Regression, Logistic|||Analysis was based on logistic regression model with multiple imputation (MI) under a missing not at random (MNAR) mechanism using retrieve dropouts with proportion of patients reaching a value of Schirmer I test \> 10 mm/5 min at Week 4 as dependent variable, treatment, gender, age class and baseline Schirmer I test value as qualitative independent variables. Site was considered as random effects that vary randomly among patients.||33.356|2.165|0.002
72538244|NCT03692078|144605812|EQUIVALENCE|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 7. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|1.035|||<|0.0001|TWO_SIDED|95.0|0.644|1.426|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 7. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 7. (mITT Population)||1.426|0.644|<.0001
72574537|NCT00372411|144675491|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.17||||0.08|TWO_SIDED|95.0|-0.23|4.58||All p-values are 2-sided with a significance level of 0.022 to adjust for multiple comparisons and interim analyses|ANCOVA|Analysis is of change at 12 weeks minus baseline adjusted for the study site as a fixed effect, the Comorbidity Disease Index, and baseline FM value.||Because randomization to usual care was stopped after 15 months as specified by the protocol, comparisons of robot-assisted therapy with usual care included only patients who were recruited during this period.||4.58|-0.23|0.08
72574538|NCT00372411|144675491|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.88||||0.02|TWO_SIDED|95.0|0.57|5.18||All p-values are 2-sided with a significance level of 0.022 to adjust for multiple comparisons and interim analyses.|Mixed Models Analysis|Secondary analysis used longitudinal methods to assess the effect of treatment on outcomes over 36 weeks with visits at 6, 12, 24, and 36 weeks.||Because randomization to usual care was stopped after 15 months as specified by the protocol comparisons of robot-assisted therapy with usual care included only patients who were recruited during this period.||5.18|0.57|0.02
72574539|NCT00372411|144675491|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.14||||0.92|TWO_SIDED|95.0|-2.94|2.65||All p-values are 2-sided with a significance level of 0.022 to adjust for multiple comparisons and interim analyses|ANCOVA|Analysis is of change at 12 weeks minus baseline adjusted for the study site as a fixed effect, the Comorbidity Disease Index, and baseline FM value.||Comparisons between robot-assisted therapy and intensive comparison therapy included all patients who underwent randomization and were evaluated.||2.65|-2.94|0.92
72627337|NCT05136170|144783679|SUPERIORITY|The following null hypothesis is defined on this endpoint: the change from baseline (reduction) in the global SANDE score at week 12 in cenegermin is lower or equal than control. The null hypothesis is rejected if the associated primary analysis p-value is lower than 0.025.|Adjusted means difference|0.59||||0.89|TWO_SIDED|95.0|-7.801|8.981||P-value of adjusted means difference between treatments from the ANCOVA model on change from baseline in the global SANDE score.|ANCOVA|||Analysis was based on ANCOVA model with multiple imputation (MI) under a missing not at random (MNAR) mechanism using retrieve dropouts with change from baseline in the global SANDE score at Week 12 as dependent variable, treatment, gender, age class and baseline global SANDE score as qualitative independent variables. Site was considered as random effects that vary randomly among patients.||8.981|-7.801|0.890
72574540|NCT00372411|144675491|SUPERIORITY_OR_OTHER||Median Difference (Net)|-0.58||||0.63|TWO_SIDED|95.0|-2.97|1.81||All p-values are 2-sided with a significance level of 0.022 to adjust for multiple comparisons and interim analyses.|Mixed Models Analysis|Secondary analysis used longitudinal methods to assess the effect of treatment on outcomes over 36 weeks with visits at 6, 12, 24, and 36 weeks.||Comparisons between robot-assisted therapy and intensive comparison therapy included all patients who underwent randomization and were evaluated.||1.81|-2.97|0.63
72574541|NCT00372411|144675492|SUPERIORITY_OR_OTHER||Mean Difference (Net)|7.64||||0.009|TWO_SIDED|95.0|2.03|13.24||All p-values are 2-sided with a significance level of 0.022 to adjust for multiple comparisons and interim analyses|ANCOVA|Analysis is change at 12 weeks minus baseline, adjusted for study site as a fixed effect, Comorbidity Disease Index, and the baseline SIS value.||Because randomization to usual care was stopped after 15 months as specified by the protocol, comparisons of robot-assisted therapy with usual care included only patients who were recruited during this period.||13.24|2.03|0.009
72538245|NCT03692078|144605812|EQUIVALENCE|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 5. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|-0.01||||1|TWO_SIDED|95.0|-0.376|0.355|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 5. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 5. (mITT Population)||0.355|-0.376|1.0000
72574542|NCT00372411|144675492|SUPERIORITY_OR_OTHER||Mean Difference (Net)|5.95||||0.04|TWO_SIDED|95.0|0.34|11.56||All p-values are 2-sided with a significance level of 0.022 to adjust for multiple comparisons and interim analyses.|Mixed Models Analysis|Secondary analysis used longitudinal methods to assess the effect of treatment on outcomes over 36 weeks with visits at 6, 12, 24, and 36 weeks.||Because randomization to usual care was stopped after 15 months as specified by the protocol comparisons of robot-assisted therapy with usual care included only patients who were recruited during this period.||11.56|0.34|0.04
72574543|NCT00372411|144675492|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.54||||0.81|TWO_SIDED|95.0|-3.87|4.94||All p-values are 2-sided with a significance level of 0.022 to adjust for multiple comparisons and interim analyses.|ANCOVA|Analysis is change at 12 weeks minus baseline, adjusted for study site as a fixed effect, Comorbidity Disease Index, and the baseline SIS value.||Comparisons between robot-assisted therapy and intensive comparison therapy included all patients who underwent randomization and were evaluated.||4.94|-3.87|0.81
72574544|NCT00372411|144675492|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.19||||0.55|TWO_SIDED|95.0|-2.74|5.12||All p-values are 2-sided with a significance level of 0.022 to adjust for multiple comparisons and interim analyses.|Mixed Models Analysis|Secondary analysis used longitudinal methods to assess the effect of treatment on outcomes over 36 weeks with visits at 6, 12, 24, and 36 weeks.||Comparisons between robot-assisted therapy and intensive comparison therapy included all patients who underwent randomization and were evaluated.||5.12|-2.74|0.55
72574545|NCT00372411|144675493|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.41||||0.22|TWO_SIDED|95.0|-11.52|2.7||All p-values are 2-sided with a significance level of 0.022 to adjust for multiple comparisons and interim analyses.|ANCOVA|Analysis is change at 12 weeks minus baseline adjusted for the study site as a fixed effect, the Comorbidity Disease Index, and baseline WMFT value.||Because randomization to usual care was stopped after 15 months as specified by the protocol comparisons of robot-assisted therapy with usual care included only patients who were recruited during this period.||2.70|-11.52|0.22
72574546|NCT00372411|144675493|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-8.1||||0.005|TWO_SIDED|95.0|-13.61|-2.6||All p-values are 2-sided with a significance level of 0.022 to adjust for multiple comparisons and interim analyses.|Mixed Models Analysis|Secondary analysis used longitudinal methods to assess the effect of treatment on outcomes over 36 weeks with visits at 6, 12, 24, and 36 weeks.||Because randomization to usual care was stopped after 15 months as specified by the protocol comparisons of robot-assisted therapy with usual care included only patients who were recruited during this period.||-2.60|-13.61|0.005
72409373|NCT02391948|144327207|OTHER||Odds Ratio (OR)|1.48|||||TWO_SIDED|95.0|1.07|2.03|||||Country was included as a model covariate. OR represents the odds of children developing 'better than expected' (top 10%) vs 'as expected' (central 80%) for each unit change in parents' perception of needs being met.|Logistic regression comparing children progressing better than expected to those progressing as expected on the Child Engagement in Daily Life - Participation outcome for the predictor parents' perception of needs being met.||2.03|1.07|
72574547|NCT00372411|144675493|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.93||||0.82|TWO_SIDED|95.0|-7.03|8.89||All p-values are 2-sided with a significance level of 0.022 to adjust for multiple comparisons and interim analyses.|ANCOVA|Analysis is change at 12 weeks minus baseline adjusted for the study site as a fixed effect, the Comorbidity Disease Index, and baseline WMFT value.||Comparisons between robot-assisted therapy and intensive comparison therapy included all patients who underwent randomization and were evaluated.||8.89|-7.03|0.82
72574548|NCT00372411|144675493|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.13||||0.55|TWO_SIDED|95.0|-9.2|4.93||All p-values are 2-sided with a significance level of 0.022 to adjust for multiple comparisons and interim analyses.|Mixed Models Analysis|Secondary analysis used longitudinal methods to assess the effect of treatment on outcomes over 36 weeks with visits at 6, 12, 24, and 36 weeks.||Comparisons between robot-assisted therapy and intensive comparison therapy included all patients who underwent randomization and were evaluated.||4.93|-9.20|0.55
72409374|NCT02391948|144327207|OTHER||Odds Ratio (OR)|1.15|||||TWO_SIDED|95.0|0.96|1.38|||||Country was included as a model covariate. OR represents the odds of children developing 'better than expected' (top 10%) vs 'as expected' (central 80%) for each unit change in the amount of focus on environment.|Logistic regression comparing children progressing better than expected to those progressing as expected on the Child Engagement in Daily Life - Participation outcome for the predictor degree of focus on environment (assistive devices, equipment, home/school modifications).||1.38|0.96|
72538246|NCT03692078|144605812|EQUIVALENCE|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 7. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|0.02||||1|TWO_SIDED|95.0|-0.417|0.457|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 7. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 7. (mITT Population)||0.457|-0.417|1.0000
72538247|NCT03692078|144605812|EQUIVALENCE|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 5. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|-0.058||||0.9999|TWO_SIDED|95.0|-0.418|0.303|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 5. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 5. (mITT Population)||0.303|-0.418|0.9999
72409375|NCT02391948|144327207|OTHER||Odds Ratio (OR)|1.3|||||TWO_SIDED|95.0|1.07|1.58|||||Country was included as a model covariate. OR represents the odds of children developing 'better than expected' (top 10%) vs 'as expected' (central 80%) for each unit change in focus on participation.|Logistic regression comparing children progressing better than expected to those progressing as expected on the Child Engagement in Daily Life - Participation outcome for the predictor focus on participation (structured play/recreation/leisure activities).||1.58|1.07|
72538248|NCT03692078|144605812|EQUIVALENCE|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 7. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|-0.132||||0.9669|TWO_SIDED|95.0|-0.566|0.301|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 7. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 7. (mITT Population)||0.301|-0.566|0.9669
72538249|NCT03692078|144605814|EQUIVALENCE|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 5. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|-1.442|||<|0.0001|TWO_SIDED|95.0|-1.604|-1.279|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 5. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 5. (mITT Population)||-1.279|-1.604|<.0001
72538250|NCT03692078|144605814|EQUIVALENCE|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 7. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|-1.413|||<|0.0001|TWO_SIDED|95.0|-1.576|-1.251|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 7. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 7. (mITT Population)||-1.251|-1.576|<.0001
72538251|NCT03692078|144605814|EQUIVALENCE|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 5. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|-1.754|||<|0.0001|TWO_SIDED|95.0|-1.907|-1.6|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 5. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 5. (mITT Population)||-1.600|-1.907|<.0001
72538252|NCT03692078|144605814|EQUIVALENCE|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 7. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|-1.816|||<|0.0001|TWO_SIDED|95.0|-1.972|-1.659|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 7. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 7. (mITT Population)||-1.659|-1.972|<.0001
72574549|NCT00372411|144675494|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.81||||0.08|TWO_SIDED|95.0|-1.73|0.11||All p-values are 2-sided with a significance level of 0.022 to adjust for multiple comparisons and interim analyses.|ANCOVA|Analysis of covariance at 12 weeks, adjusted for study site as a fixed effect, Comorbidity Disease Index, and the baseline value of the outcome.||Because randomization to usual care was stopped after 15 months as specified by the protocol comparisons of robot-assisted therapy with usual care included only patients who were recruited during this period.||0.11|-1.73|0.08
72409376|NCT02391948|144327207|OTHER||Odds Ratio (OR)|0.93|||||TWO_SIDED|95.0|0.72|1.58|||||Country was included as a model covariate. OR represents the odds of children developing 'better than expected' (top 10%) vs 'as expected' (central 80%) for each unit change in amount of physical therapy services.|Logistic regression comparing children progressing better than expected to those progressing as expected on the Child Engagement in Daily Life - Participation outcome for the predictor amount of physical therapy services.||1.58|0.72|
72538253|NCT03692078|144605814|EQUIVALENCE|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 5. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|-1.654|||<|0.0001|TWO_SIDED|95.0|-1.81|-1.498|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 5. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 5. (mITT Population)||-1.498|-1.810|<.0001
72538254|NCT03692078|144605814|EQUIVALENCE|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 7. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|-1.829|||<|0.0001|TWO_SIDED|95.0|-1.986|-1.673|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 7. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 7. (mITT Population)||-1.673|-1.986|<.0001
72574550|NCT00372411|144675494|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.84||||0.03|TWO_SIDED|95.0|-1.62|-0.06||All p-values are 2-sided with a significance level of 0.022 to adjust for multiple comparisons and interim analyses.|ANCOVA|Analysis of covariance at 12 weeks, adjusted for study site as a fixed effect, Comorbidity Disease Index, and the baseline value of the outcome.||Comparisons between robot-assisted therapy and intensive comparison therapy included all patients who underwent randomization and were evaluated.||-0.06|-1.62|0.03
72574551|NCT00372411|144675495|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.01||||0.95|TWO_SIDED|95.0|-0.25|0.26||All p-values are 2-sided with a significance level of 0.022 to adjust for multiple comparisons and interim analyses.|ANCOVA|Analysis of covariance at 12 weeks, adjusted for study site as a fixed effect, Comorbidity Disease Index, and the baseline value of the outcome.||Because randomization to usual care was stopped after 15 months as specified by the protocol comparisons of robot-assisted therapy with usual care included only patients who were recruited during this period.||0.26|-0.25|0.95
72574552|NCT00372411|144675495|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.19||||0.1|TWO_SIDED|95.0|-0.42|0.04||All p-values are 2-sided with a significance level of 0.022 to adjust for multiple comparisons and interim analyses.|ANCOVA|Analysis of covariance at 12 weeks, adjusted for study site as a fixed effect, Comorbidity Disease Index, and the baseline value of the outcome.||Comparisons between robot-assisted therapy and intensive comparison therapy included all patients who underwent randomization and were evaluated.||0.04|-0.42|0.10
72574553|NCT01284361|144675500|SUPERIORITY_OR_OTHER||Proportion|91.5|||||TWO_SIDED|95.0|84.5|97.5|||||Seventy five of the 82 subjects (91.5%) preferred the longer commercially available catheter over the experimental 30 cm catheter.|The sample size of 81 subjects provides a 10.8% margin of error.||97.5|84.5|
72574554|NCT00324649|144675512|SUPERIORITY_OR_OTHER|||||||0.0014||95.0||||No adjustments for multiple comparisons were made.|Wilcoxon Rank Sum test|No adjustments were made.||Null Hypothesis: changes from baseline in the two treatment groups are equal. Alternative Hypothesis: changes from baseline in the two treatment groups are different (two sided).||||0.0014
72574555|NCT00324649|144675513|SUPERIORITY_OR_OTHER|||||||0.9713||95.0||||No adjustments for multiple comparisons were made.|Wilcoxon Rank Sum test|No adjustments were made.||Null Hypothesis: changes from baseline in the two treatment groups are equal. Alternative Hypothesis: changes from baseline in the two treatment groups are different (two sided).||||0.9713
72574556|NCT00324649|144675514|SUPERIORITY_OR_OTHER|||||||0.9725||95.0||||No adjustments for multiple comparisons were made.|Wilcoxon Rank Sum test|No adjustments were made.||Null Hypothesis: changes from baseline in the two treatment groups are equal. Alternative Hypothesis: changes from baseline in the two treatment groups are different (two sided).||||0.9725
72574557|NCT00324649|144675515|SUPERIORITY_OR_OTHER|||||||0.0078||95.0||||No adjustments for multiple comparisons were made.|Wilcoxon Rank Sum test|No adjustments were made.||Null Hypothesis: changes from baseline in the two treatment groups are equal. Alternative Hypothesis: changes from baseline in the two treatment groups are different (two sided).||||0.0078
72574558|NCT00324649|144675516|SUPERIORITY_OR_OTHER|||||||0.6984||95.0||||No adjustments for multiple comparisons were made.|Wilcoxon Rank Sum test|No adjustments were made.||Null Hypothesis: percentages of days with compliance in the two treatment groups are equal. Alternative Hypothesis: percentages of days with compliance in the two treatment groups are different (two sided).||||0.6984
72574559|NCT00324649|144675517|SUPERIORITY_OR_OTHER||Mean Difference (Net)|14.3||||0.1165||95.0|-0.9|29.4||No adjustments for multiple comparisons were made.|Fisher Exact|No adjustments were made.|The difference is for Truvada minus zidovudine/lamivudine. The 95% confidence interval on the mean difference between treatment groups is based on the normal approximation.|"Null Hypothesis: treatment is not associated with the observed virologic response.~Alternative Hypothesis: treatment is associated with the observed virologic response."||29.4|-0.9|0.1165
72574560|NCT00324649|144675520|SUPERIORITY_OR_OTHER|||||||0.0789||95.0||||No adjustments for multiple comparisons were made.|Wilcoxon Rank Sum test|No adjustments were made.||Null Hypothesis: changes from baseline in the two treatment groups are equal. Alternative Hypothesis: changes from baseline in the two treatment groups are different (two sided).||||0.0789
72409377|NCT02391948|144327207|OTHER||Odds Ratio (OR)|0.98|||||TWO_SIDED|95.0|0.74|1.28|||||Country was included as a model covariate. OR represents the odds of children developing 'better than expected' (top 10%) vs 'as expected' (central 80%) for each unit change in amount of occupational therapy services.|Logistic regression comparing children progressing better than expected to those progressing as expected on the Child Engagement in Daily Life - Participation outcome for the predictor amount of occupational therapy.||1.28|0.74|
72409378|NCT02391948|144327207|OTHER||Odds Ratio (OR)|1.25|||||TWO_SIDED|95.0|0.97|1.6|||||Country was included as a model covariate. OR represents the odds of children developing 'better than expected' (top 10%) vs 'as expected' (central 80%) for each unit change in amount of speech and language therapy.|Logistic regression comparing children progressing better than expected to those progressing as expected on the Child Engagement in Daily Life - Participation outcome for the predictor amount of speech and language therapy.||1.60|0.97|
72409379|NCT02391948|144327207|OTHER||Odds Ratio (OR)|1.37|||||TWO_SIDED|95.0|1.0|1.88|||||Country was included as a model covariate. OR represents the odds of children developing 'better than expected' (top 10%) vs 'as expected' (central 80%) for each unit change in parents' perception of needs being met.|Logistic regression comparing children progressing better than expected to those progressing as expected on the Child Engagement in Daily Life - Self Care outcome for the predictor family-centred service.||1.88|1.00|
72538255|NCT03692078|144605814|EQUIVALENCE|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 5. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|-2.184|||<|0.0001|TWO_SIDED|95.0|-2.379|-1.989|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 5. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 5. (mITT Population)||-1.989|-2.379|<.0001
72574561|NCT00324649|144675521|SUPERIORITY_OR_OTHER|||||||0.9633||95.0||||No adjustments for multiple comparisons were made.|Wilcoxon Rank Sum test|No adjustments were made.||Null Hypothesis: changes from baseline in the two treatment groups are equal. Alternative Hypothesis: changes from baseline in the two treatment groups are different (two sided).||||0.9633
72574562|NCT00324649|144675522|SUPERIORITY_OR_OTHER|||||||0.9686||95.0||||No adjustments for multiple comparisons were made.|Wilcoxon Rank Sum test|No adjustments were made.||Null Hypothesis: changes from baseline in the two treatment groups are equal. Alternative Hypothesis: changes from baseline in the two treatment groups are different (two sided).||||0.9686
72574563|NCT00324649|144675523|SUPERIORITY_OR_OTHER|||||||0.6638||95.0||||No adjustments for multiple comparisons were performed.|Wilcoxon Rank Sum test|No adjustments were made.||Null Hypothesis: changes from baseline in the two treatment groups are equal. Alternative Hypothesis: changes from baseline in the two treatment groups are different (two sided).||||0.6638
72574564|NCT00324649|144675524|SUPERIORITY_OR_OTHER|||||||0.2907||95.0||||No adjustments for multiple comparisons were made.|Wilcoxon Rank Sum test|No adjustments were made.||Null Hypothesis: changes from baseline in the two treatment groups are equal. Alternative Hypothesis: changes from baseline in the two treatment groups are different (two sided).||||0.2907
72538256|NCT03692078|144605814|EQUIVALENCE|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 7. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|-2.27|||<|0.0001|TWO_SIDED|95.0|-2.468|-2.071|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 7. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 7. (mITT Population)||-2.071|-2.468|<.0001
72574565|NCT00324649|144675525|SUPERIORITY_OR_OTHER|||||||0.0072||95.0||||No adjustments for multiple comparisons were made.|Wilcoxon Rank Sum test|No adjustments were made.||Null Hypothesis: changes from baseline in the two treatment groups are equal. Alternative Hypothesis: changes from baseline in the two treatment groups are different (two sided).||||0.0072
72574566|NCT00324649|144675526|SUPERIORITY_OR_OTHER|||||||0.0006||95.0||||No adjustments for multiple comparisons were made.|Wilcoxon Rank Sum test|No adjustments were made.||Null Hypothesis: changes from baseline in the two treatment groups are equal. Alternative Hypothesis: changes from baseline in the two treatment groups are different (two sided).||||0.0006
72574567|NCT00324649|144675527|SUPERIORITY_OR_OTHER|||||||0.1785||95.0||||No adjustments for multiple comparisons were made.|Wilcoxon Rank Sum test|No adjustments were made.||Null Hypothesis: changes from baseline in the two treatment groups are equal. Alternative Hypothesis: changes from baseline in the two treatment groups are different (two sided).||||0.1785
72627338|NCT05136170|144783680|SUPERIORITY|Analysis was based on logistic regression model with multiple imputation (MI) under missing not at random (MNAR) using retrieve dropouts with proportion of patients reaching a value of Schirmer I test \>10 mm/5 min at Week 8 as dependent variable, treatment, gender, age class and baseline Schirmer I test value as qualitative independent variables. Site was considered as random effects that vary randomly among patients.|Odds Ratio (OR)|6.648||||0.022|TWO_SIDED|95.0|1.307|33.808|||Regression, Logistic|||This key secondary endpoint was analyzed by means of a logistic regression model with proportion of patients reaching a value of Schirmer I test \>10mm/5min at Week 8 as dependent variable, treatment, gender, age class and baseline Schirmer I test value as fixed effects and site as random effect.||33.808|1.307|0.022
72574568|NCT01988129|144675530|SUPERIORITY_OR_OTHER|||||||0.66|TWO_SIDED||||||t-test, 2 sided|||Analysis for 'sick' days||||0.66
72574569|NCT01988129|144675530|SUPERIORITY_OR_OTHER|||||||0.033|TWO_SIDED||||||t-test, 2 sided|||Analysis for 'disability/injury' days||||0.033
72409380|NCT02391948|144327207|OTHER||Odds Ratio (OR)|1.06|||||TWO_SIDED|95.0|0.78|1.44|||||Country was included as a model covariate. OR represents the odds of children developing 'better than expected' (top 10%) vs 'as expected' (central 80%) for each unit change in parents' perception of needs being met.|Logistic regression comparing children progressing better than expected to those progressing as expected on the Early Clinical Assessment of Balance outcome for the predictor family-centred service.||1.44|0.78|
72409381|NCT02391948|144327207|OTHER||Odds Ratio (OR)|0.83|||||TWO_SIDED|95.0|0.54|1.26|||||Country was included as a model covariate. OR represents the odds of children developing 'better than expected' (top 10%) vs 'as expected' (central 80%) for each unit change in parents' perception of needs being met.|Logistic regression comparing children progressing better than expected to those progressing as expected on the Six Minute Walk Test outcome for the predictor family-centred service.||1.26|0.54|
72574570|NCT01988129|144675530|SUPERIORITY_OR_OTHER|||||||0.003|||||||Mixed Models Analysis|Mixed model analysis with nested random effects for possible station-level and station-pairing correlation (3-level hierarchical linear model)||Mixed model analysis was conducted for 'disability/injury' days||||0.003
72574571|NCT01988129|144675531|SUPERIORITY_OR_OTHER|||||||0.87|TWO_SIDED||||||t-test, 2 sided|||||||0.87
72574572|NCT01988129|144675532|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.76||||0.31|TWO_SIDED|95.0|0.6|0.98|||t-test, 2 sided||The Odds Ratio analyses compared the odds of reporting at least one injury during the study between those who did (n=560) and did not (n=629) attend the education sessions, regardless of station assignment (intervention or control).|||0.98|0.60|0.31
72574573|NCT01988129|144675533|SUPERIORITY_OR_OTHER|||||||0.22|TWO_SIDED||||||Paired t-test|||Of the 100 participants who completed both the pre- and post-study survey (see Patient Flow), only 62 completed answered the question about sleep duration at both time points||||0.22
72574574|NCT01988129|144675534|SUPERIORITY_OR_OTHER|||||||0.65|TWO_SIDED||||||paired t-test|||||||0.65
72574575|NCT01988129|144675535|SUPERIORITY_OR_OTHER|||||||0.71|TWO_SIDED||||||paired t-test|||||||0.71
72574576|NCT01988129|144675537|SUPERIORITY_OR_OTHER||Percentage of firefighters screened|41.5|||||TWO_SIDED|||||||||This analysis describes the prevalence of the risk of any sleep disorders; there is no comparison group||||
72574577|NCT01988129|144675537|SUPERIORITY_OR_OTHER||Percentage of firefighters screene|31.3|||||TWO_SIDED|||||||||This analysis describes the prevalence of the risk of obstructive sleep apnea only; there is no comparison group||||
72409382|NCT02391948|144327207|OTHER||Odds Ratio (OR)|1.37|||||TWO_SIDED|95.0|1.0|1.87|||||Country was included as a model covariate. OR represents the odds of children developing 'better than expected' (top 10%) vs 'as expected' (central 80%) for each unit change in parents' perception of needs being met.|Logistic regression comparing children progressing better than expected to those progressing as expected on the Child Engagement in Daily Life - Self Care outcome for the predictor parents' perception of needs being met.||1.87|1.00|
72538257|NCT03692078|144605814|EQUIVALENCE|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 5. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|-2.413|||<|0.0001|TWO_SIDED|95.0|-2.607|-2.219|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 5. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 5. (mITT Population)||-2.219|-2.607|<.0001
72574578|NCT01988129|144675537|SUPERIORITY_OR_OTHER||Percentage of firefighters screene|7.7|||||TWO_SIDED|||||||||This analysis describes the prevalence of the risk of insomnia; there is no comparison group||||
72574579|NCT01988129|144675537|SUPERIORITY_OR_OTHER||Percentage of firefighters screene|3.5|||||TWO_SIDED|||||||||This analysis describes the prevalence of the risk of restless legs syndrome only; there is no comparison group||||
72574580|NCT01988129|144675537|SUPERIORITY_OR_OTHER||Percentage of firefighters screene|9.3|||||TWO_SIDED|||||||||This analysis describes the prevalence of the risk of shiftwork disorder only; there is no comparison group||||
72574581|NCT01988129|144675538|SUPERIORITY_OR_OTHER|||||||0.31|TWO_SIDED||||||paired t-test|||||||0.31
72574582|NCT01988129|144675539|SUPERIORITY_OR_OTHER|||||||0.16|TWO_SIDED||||||Paired t-test, 2-sided|||Sleeping while stopped in traffic||||0.16
72574583|NCT01988129|144675540|SUPERIORITY_OR_OTHER|||||||0.46|TWO_SIDED||||||Paired t-test, 2-sided|||||||0.46
72574584|NCT04713553|144675542|EQUIVALENCE|Equivalence was to be achieved if the 2-sided 95% confidence interval (CI) for GMR falls within the interval (0.67, 1.5).|Geometric mean ratio|1.01|||||TWO_SIDED|95.0|0.91|1.13|||||GMRs and corresponding 2-sided 95% CIs were calculated by exponentiating difference in LS means and corresponding CIs based on analysis of logarithmically transformed assay results using a linear regression model with terms of age and vaccine group.|||1.13|0.91|
72574585|NCT04713553|144675542|EQUIVALENCE|Equivalence was to be achieved if the 2-sided 95% CI for GMR falls within the interval (0.67, 1.5).|Geometric mean ratio|0.93|||||TWO_SIDED|95.0|0.83|1.04|||||GMRs and corresponding 2-sided 95% CIs were calculated by exponentiating difference in LS means and corresponding CIs based on analysis of logarithmically transformed assay results using a linear regression model with terms of age and vaccine group.|||1.04|0.83|
72574586|NCT04713553|144675542|EQUIVALENCE|Equivalence was to be achieved if the 2-sided 95% CI for GMR falls within the interval (0.67, 1.5).|Geometric mean ratio|0.92|||||TWO_SIDED|95.0|0.82|1.03|||||GMRs and corresponding 2-sided 95% CIs were calculated by exponentiating difference in LS means and corresponding CIs based on analysis of logarithmically transformed assay results using a linear regression model with terms of age and vaccine group.|||1.03|0.82|
72574587|NCT04713553|144675543|EQUIVALENCE|Equivalence was to be achieved if the 2-sided 95% CI for GMR falls within the interval (0.67, 1.5).|Geometric mean ratio|0.95|||||TWO_SIDED|95.0|0.84|1.07|||||GMRs and corresponding 2-sided 95% CIs were calculated by exponentiating difference in LS means and corresponding CIs based on analysis of logarithmically transformed assay results using a linear regression model with terms of age and vaccine group.|||1.07|0.84|
72574588|NCT04713553|144675544|NON_INFERIORITY|Noninferiority of the 20 mcg dose to the corresponding 30 mcg dose was said to be achieved if the lower limit of the 2-sided 95% CI for the GMR is \>0.67.|Geometric Mean Ratio|0.93|||||TWO_SIDED|95.0|0.84|1.02|||||GMRs were calculated by exponentiating the difference in LS means and corresponding CIs based on analysis of logarithmically transformed assay results using a linear regression model with terms of age and vaccine group|||1.02|0.84|
72574589|NCT01853930|144675594|SUPERIORITY|The purpose of the superiority test is to show if laboratory based training is superior to an independent home-based training option.||||||0.876|||||||t-test, 2 sided|t= -0.157 df= 30||||||0.876
72574590|NCT01243112|144675608|SUPERIORITY_OR_OTHER|||||||0.359||95.0|||||ANOVA|||Null Hypothesis is that no difference would be measured between treatment arms.||||0.359
72574591|NCT01243112|144675609|SUPERIORITY_OR_OTHER|||||||0.49||95.0|||||ANOVA|||||||0.490
72574592|NCT01081834|144675610|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-0.91|STANDARD_ERROR_OF_MEAN|0.091|<|0.001|TWO_SIDED|95.0|-1.088|-0.729|||ANCOVA|||||-0.729|-1.088|<0.001
72574593|NCT01081834|144675610|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-1.16|STANDARD_ERROR_OF_MEAN|0.091|<|0.001|TWO_SIDED|95.0|-1.342|-0.985|||ANCOVA|||||-0.985|-1.342|<0.001
72574594|NCT01081834|144675612|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.34|||<|0.001|TWO_SIDED|95.0|3.1|9.23|||Regression, Logistic|||||9.23|3.10|<0.001
72574595|NCT01081834|144675612|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|14.61|||<|0.001|TWO_SIDED|95.0|8.14|26.25|||Regression, Logistic|||||26.25|8.14|<0.001
72409383|NCT02391948|144327207|OTHER||Odds Ratio (OR)|1.13|||||TWO_SIDED|95.0|0.83|1.53|||||Country was included as a model covariate. OR represents the odds of children developing 'better than expected' (top 10%) vs 'as expected' (central 80%) for each unit change in parents' perception of needs being met.|Logistic regression comparing children progressing better than expected to those progressing as expected on the Early Clinical Assessment of Balance outcome for the predictor parents' perception of needs being met.||1.53|0.83|
72574596|NCT01081834|144675613|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-35.5|STANDARD_ERROR_OF_MEAN|3.42|<|0.001|TWO_SIDED|95.0|-42.22|-28.78|||ANCOVA|||||-28.78|-42.22|<0.001
72574597|NCT01081834|144675613|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-43.4|STANDARD_ERROR_OF_MEAN|3.402|<|0.001|TWO_SIDED|95.0|-50.06|-36.69|||ANCOVA|||||-36.69|-50.06|<0.001
72538258|NCT03692078|144605814|EQUIVALENCE|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 7. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|-2.349|||<|0.0001|TWO_SIDED|95.0|-2.549|-2.149|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 7. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 7. (mITT Population)||-2.149|-2.549|<.0001
72538259|NCT03692078|144605814|EQUIVALENCE|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 5. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|-2.227|||<|0.0001|TWO_SIDED|95.0|-2.416|-2.038|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 5. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 5. (mITT Population)||-2.038|-2.416|<.0001
72538260|NCT03692078|144605814|EQUIVALENCE|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 7. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|-2.154|||<|0.0001|TWO_SIDED|95.0|-2.345|-1.962|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 7. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 7. (mITT Population)||-1.962|-2.345|<.0001
72538261|NCT03692078|144605814|EQUIVALENCE|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 5. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-0.312||||0.0552|TWO_SIDED|95.0|-0.628|0.004|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 5. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 5. (mITT Population)||0.004|-0.628|0.0552
72538262|NCT03692078|144605814|EQUIVALENCE|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 7. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-0.402||||0.0055|TWO_SIDED|95.0|-0.722|-0.083|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 7. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 7. (mITT Population)||-0.083|-0.722|0.0055
72574598|NCT01081834|144675614|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-49.1|STANDARD_ERROR_OF_MEAN|5.629|<|0.001|TWO_SIDED|95.0|-59.12|-36.99|||ANCOVA|||||-36.99|-59.12|<0.001
72574599|NCT01081834|144675614|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-64.0|STANDARD_ERROR_OF_MEAN|5.616|<|0.001|TWO_SIDED|95.0|-75.02|-52.94|||ANCOVA|||||-52.94|-75.02|<0.001
72574600|NCT01081834|144675615|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-2.2|STANDARD_ERROR_OF_MEAN|0.3|<|0.001|TWO_SIDED|95.0|-2.9|-1.6|||ANCOVA|||||-1.6|-2.9|<0.001
72574601|NCT01081834|144675615|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-3.3|STANDARD_ERROR_OF_MEAN|0.3|<|0.001|TWO_SIDED|95.0|-4.0|-2.6|||ANCOVA|||||-2.6|-4.0|<0.001
72627339|NCT05136170|144783681|SUPERIORITY||Adjusted means difference|0.221||||0.962|TWO_SIDED|95.0|-8.934|9.377||P-value of adjusted means difference between treatments from the ANCOVA model on change from baseline in SANDE score for severity at Week 12.|ANCOVA|||Analysis was based on ANCOVA model with multiple imputation (MI) under missing not at random (MNAR) using retrieve dropouts with change from baseline in the severity SANDE score at Week 12 as dependent variable, treatment, gender, age class and baseline severity SANDE score as qualitative independent variables.Site was considered as random effects that vary randomly among patients.||9.377|-8.934|0.962
72574602|NCT01081834|144675616|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-3.71|STANDARD_ERROR_OF_MEAN|1.093|<|0.001|TWO_SIDED|95.0|-5.86|-1.568|||ANCOVA|||||-1.568|-5.860|<0.001
72574603|NCT01081834|144675616|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-5.42|STANDARD_ERROR_OF_MEAN|1.088|<|0.001|TWO_SIDED|95.0|-7.556|-3.28|||ANCOVA|||||-3.280|-7.556|<0.001
72574604|NCT01081834|144675617|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-5.3|STANDARD_ERROR_OF_MEAN|4.8||0.267|TWO_SIDED|95.0|-14.8|4.1|||ANCOVA|||||4.1|-14.8|0.267
72574605|NCT01081834|144675617|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-10.2|STANDARD_ERROR_OF_MEAN|4.8||0.034|TWO_SIDED|95.0|-19.6|-0.8|||ANCOVA|||||-0.8|-19.6|0.034
72409384|NCT02391948|144327207|OTHER||Odds Ratio (OR)|0.87|||||TWO_SIDED|95.0|0.59|1.3|||||Country was included as a model covariate. OR represents the odds of children developing 'better than expected' (top 10%) vs 'as expected' (central 80%) for each unit change in parents' perception of needs being met.|Logistic regression comparing children progressing better than expected to those progressing as expected on the Six Minute Walk Test outcome for the predictor parents' perception of needs being met.||1.3|0.59|
72409385|NCT02391948|144327207|OTHER||Odds Ratio (OR)|1.08|||||TWO_SIDED|95.0|0.9|1.29|||||Country was included as a model covariate. OR represents the odds of children developing 'better than expected' (top 10%) vs 'as expected' (central 80%) for each unit change in parents' perception of needs being met.|Logistic regression comparing children progressing better than expected to those progressing as expected on the Child Engagement in Daily Life - Self Care outcome for the predictor degree of focus on environment (assistive devices, equipment, home/school modifications).||1.29|0.9|
72409386|NCT02391948|144327207|OTHER||Odds Ratio (OR)|1.02|||||TWO_SIDED|95.0|0.86|1.22||||||Logistic regression comparing children progressing better than expected to those progressing as expected on the Early Clinical Assessment of Balance outcome for the predictor degree of focus on environment (assistive devices, equipment, home/school modifications).||1.22|0.86|
72538263|NCT03692078|144605814|EQUIVALENCE|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 5. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-0.212||||0.3834|TWO_SIDED|95.0|-0.53|0.105|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 5. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 5. (mITT Population)||0.105|-0.530|0.3834
72538264|NCT03692078|144605814|EQUIVALENCE|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 7. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-0.416||||0.0033|TWO_SIDED|95.0|-0.734|-0.099|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 7. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 7. (mITT Population)||-0.099|-0.734|0.0033
72538265|NCT03692078|144605814|EQUIVALENCE|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 5. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-0.743|||<|0.0001|TWO_SIDED|95.0|-1.103|-0.382|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 5. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 5. (mITT Population)||-0.382|-1.103|<.0001
72538266|NCT03692078|144605814|EQUIVALENCE|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 7. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-0.857|||<|0.0001|TWO_SIDED|95.0|-1.22|-0.493|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 7. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 7. (mITT Population)||-0.493|-1.220|<.0001
72538267|NCT03692078|144605814|EQUIVALENCE|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 5. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-0.971|||<|0.0001|TWO_SIDED|95.0|-1.327|-0.616|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 5. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 5. (mITT Population)||-0.616|-1.327|<.0001
72574606|NCT01081834|144675618|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|6.7|STANDARD_ERROR_OF_MEAN|1.9|<|0.001|TWO_SIDED|95.0|2.9|10.6|||ANCOVA|||||10.6|2.9|<0.001
72574607|NCT01081834|144675618|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|6.0|STANDARD_ERROR_OF_MEAN|1.9||0.002|TWO_SIDED|95.0|2.2|9.9|||ANCOVA|||||9.9|2.2|0.002
72409387|NCT02391948|144327207|OTHER||Odds Ratio (OR)|0.89|||||TWO_SIDED|95.0|0.7|1.13|||||Country was included as a model covariate. OR represents the odds of children developing 'better than expected' (top 10%) vs 'as expected' (central 80%) for each unit change in parents' perception of needs being met.|Logistic regression comparing children progressing better than expected to those progressing as expected on the Six Minute Walk Test outcome for the predictor degree of focus on environment (assistive devices, equipment, home/school modifications).||1.13|0.7|
72409388|NCT02391948|144327207|OTHER||Odds Ratio (OR)|1.09|||||TWO_SIDED|95.0|0.9|1.31|||||Country was included as a model covariate. OR represents the odds of children developing 'better than expected' (top 10%) vs 'as expected' (central 80%) for each unit change in parents' perception of needs being met.|Logistic regression comparing children progressing better than expected to those progressing as expected on the Child Engagement in Daily Life - Self Care outcome for the predictor focus on participation (structured play/recreation/leisure activities).||1.31|0.9|
72409389|NCT02391948|144327207|OTHER||Odds Ratio (OR)|1.1|||||TWO_SIDED|95.0|0.91|1.32|||||Country was included as a model covariate. OR represents the odds of children developing 'better than expected' (top 10%) vs 'as expected' (central 80%) for each unit change in parents' perception of needs being met.|Logistic regression comparing children progressing better than expected to those progressing as expected on the Early Clinical Assessment of Balance outcome for the predictor focus on participation (structured play/recreation/leisure activities).||1.32|0.91|
72538268|NCT03692078|144605814|EQUIVALENCE|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 7. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-0.936|||<|0.0001|TWO_SIDED|95.0|-1.298|-0.574|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 7. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 7. (mITT Population)||-0.574|-1.298|<.0001
72538269|NCT03692078|144605814|EQUIVALENCE|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 5. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|0.473||||0.0016|TWO_SIDED|95.0|0.133|0.813|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 5. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 5. (mITT Population)||0.813|0.133|0.0016
72538270|NCT03692078|144605814|EQUIVALENCE|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 7. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|0.338||||0.0582|TWO_SIDED|95.0|-0.007|0.683|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 7. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 7. (mITT Population)||0.683|-0.007|0.0582
72538271|NCT03692078|144605814|EQUIVALENCE|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 5. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|0.573|||<|0.0001|TWO_SIDED|95.0|0.232|0.914|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 5. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 5. (mITT Population)||0.914|0.232|<.0001
72538272|NCT03692078|144605814|EQUIVALENCE|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 7. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|0.324||||0.0745|TWO_SIDED|95.0|-0.02|0.668|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 7. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 7. (mITT Population)||0.668|-0.020|0.0745
72538273|NCT03692078|144605814|EQUIVALENCE|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 5. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|0.043||||1|TWO_SIDED|95.0|-0.337|0.422|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 5. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 5. (mITT Population)||0.422|-0.337|1.0000
72538274|NCT03692078|144605814|EQUIVALENCE|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 7. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|-0.116||||0.9759|TWO_SIDED|95.0|-0.501|0.268|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 7. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 7. (mITT Population)||0.268|-0.501|0.9759
72538275|NCT03692078|144605814|EQUIVALENCE|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 5. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|-0.186||||0.7128|TWO_SIDED|95.0|-0.565|0.192|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 5. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 5. (mITT Population)||0.192|-0.565|0.7128
72574608|NCT05502081|144675633|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|||||||<0.001
72574609|NCT05502081|144675633|SUPERIORITY|||||||0.176|||||||Kruskal-Wallis|||||||0.176
72574610|NCT05502081|144675633|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|||||||<0.001
72574611|NCT05502081|144675633|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|||||||<0.001
72574612|NCT05502081|144675634|SUPERIORITY|||||||0.011|||||||Kruskal-Wallis|||||||0.011
72574613|NCT05502081|144675634|SUPERIORITY|||||||0.021|||||||Kruskal-Wallis|||||||0.021
72574614|NCT05502081|144675634|SUPERIORITY|||||||0.42|||||||Kruskal-Wallis|||||||0.42
72574615|NCT05502081|144675634|SUPERIORITY|||||||0.007|||||||Kruskal-Wallis|||||||0.007
72574616|NCT05502081|144675635|SUPERIORITY|||||||0.99|||||||Kruskal-Wallis|||||||0.99
72574617|NCT05502081|144675636|SUPERIORITY|||||||0.005|||||||Kruskal-Wallis|||||||0.005
72574618|NCT05502081|144675636|SUPERIORITY|||||||0.99|||||||Kruskal-Wallis|||||||0.99
72574619|NCT05502081|144675636|SUPERIORITY|||||||0.003|||||||Kruskal-Wallis|||||||0.003
72409390|NCT02391948|144327207|OTHER||Odds Ratio (OR)|0.97|||||TWO_SIDED|95.0|0.76|1.24|||||Country was included as a model covariate. OR represents the odds of children developing 'better than expected' (top 10%) vs 'as expected' (central 80%) for each unit change in parents' perception of needs being met.|Logistic regression comparing children progressing better than expected to those progressing as expected on the Six Minute Walk Test outcome for the predictor focus on participation (structured play/recreation/leisure activities).||1.24|0.76|
72409391|NCT02391948|144327207|OTHER||Odds Ratio (OR)|0.9|||||TWO_SIDED|95.0|0.7|1.15|||||Country was included as a model covariate. OR represents the odds of children developing 'better than expected' (top 10%) vs 'as expected' (central 80%) for each unit change in parents' perception of needs being met.|Logistic regression comparing children progressing better than expected to those progressing as expected on the Child Engagement in Daily Life - Self Care outcome for the predictor amount of physical therapy services.||1.15|.7|
72538276|NCT03692078|144605814|EQUIVALENCE|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 7. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|-0.195||||0.6816|TWO_SIDED|95.0|-0.582|0.192|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 7. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 7. (mITT Population)||0.192|-0.582|0.6816
72538277|NCT03692078|144605816|EQUIVALENCE|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 5. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|-0.948|||<|0.0001|TWO_SIDED|95.0|-1.146|-0.75|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 5. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 5. (mITT Population)||-0.750|-1.146|<.0001
72574620|NCT05502081|144675636|SUPERIORITY|||||||0.003|||||||Kruskal-Wallis|||||||0.003
72574621|NCT05502081|144675637|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|||||||<0.001
72574622|NCT05502081|144675637|SUPERIORITY|||||||0.119|||||||Kruskal-Wallis|||||||0.119
72574623|NCT05502081|144675637|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|||||||<0.001
72574624|NCT05502081|144675637|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|||||||<0.001
72574625|NCT05502081|144675638|SUPERIORITY|||||||0.933|||||||Kruskal-Wallis|||||||0.933
72574626|NCT05502081|144675639|SUPERIORITY|||||||0.011|||||||Kruskal-Wallis|||||||0.011
72574627|NCT05502081|144675639|SUPERIORITY|||||||0.054|||||||Kruskal-Wallis|||||||0.054
72574628|NCT05502081|144675639|SUPERIORITY|||||||0.185|||||||Kruskal-Wallis|||||||0.185
72574629|NCT05502081|144675639|SUPERIORITY|||||||0.004|||||||Kruskal-Wallis|||||||0.004
72574630|NCT05502081|144675640|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|||||||<0.001
72409392|NCT02391948|144327207|OTHER||Odds Ratio (OR)|1.05|||||TWO_SIDED|95.0|0.74|1.48|||||Country was included as a model covariate. OR represents the odds of children developing 'better than expected' (top 10%) vs 'as expected' (central 80%) for each unit change in parents' perception of needs being met.|Logistic regression comparing children progressing better than expected to those progressing as expected on the Six Minute Walk Test outcome for the predictor amount of physical therapy services.||1.48|.74|
72574631|NCT05502081|144675640|SUPERIORITY|||||||0.001|||||||Kruskal-Wallis|||||||0.001
72574632|NCT05502081|144675640|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|||||||<0.001
72574633|NCT05502081|144675640|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|||||||<0.001
72574634|NCT05502081|144675641|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|||||||<0.001
72574635|NCT05502081|144675641|SUPERIORITY|||||||0.758|||||||Kruskal-Wallis|||||||0.758
72574636|NCT05502081|144675641|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|||||||<0.001
72574637|NCT05502081|144675641|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|||||||<0.001
72574638|NCT05502081|144675642|SUPERIORITY|||||||0.412|||||||Kruskal-Wallis|||||||0.412
72574639|NCT05502081|144675643|SUPERIORITY|||||||0.106|||||||Kruskal-Wallis|||||||0.106
72574640|NCT05502081|144675644|SUPERIORITY|||||||0.01|||||||Kruskal-Wallis|||||||0.01
72574641|NCT05502081|144675644|SUPERIORITY|||||||0.06|||||||Kruskal-Wallis|||||||0.06
72574642|NCT05502081|144675644|SUPERIORITY|||||||0.156|||||||Kruskal-Wallis|||||||0.156
72574643|NCT05502081|144675644|SUPERIORITY|||||||0.003|||||||Kruskal-Wallis|||||||0.003
72574644|NCT05502081|144675645|SUPERIORITY|||||||0.219|||||||Kruskal-Wallis|||||||0.219
72574645|NCT05502081|144675646|SUPERIORITY|||||||0.298|||||||Kruskal-Wallis|||||||0.298
72574646|NCT05502081|144675647|SUPERIORITY|||||||0.015|||||||Kruskal-Wallis|||||||0.015
72574647|NCT05502081|144675647|SUPERIORITY|||||||0.232|||||||Kruskal-Wallis|||||||0.232
72574648|NCT05502081|144675647|SUPERIORITY|||||||0.004|||||||Kruskal-Wallis|||||||0.004
72574649|NCT05502081|144675647|SUPERIORITY|||||||0.054|||||||Kruskal-Wallis|||||||0.054
72574650|NCT05502081|144675648|SUPERIORITY|||||||0.68|||||||Kruskal-Wallis|||||||0.68
72574651|NCT05502081|144675648|SUPERIORITY|||||||0.232|||||||Kruskal-Wallis|||||||0.232
72574652|NCT05502081|144675648|SUPERIORITY|||||||0.004|||||||Kruskal-Wallis|||||||0.004
72574653|NCT05502081|144675648|SUPERIORITY|||||||0.054|||||||Kruskal-Wallis|||||||0.054
72574654|NCT05502081|144675649|SUPERIORITY|||||||0.002|||||||Kruskal-Wallis|||||||0.002
72574655|NCT05502081|144675649|SUPERIORITY|||||||0.557|||||||Kruskal-Wallis|||||||0.557
72574656|NCT05502081|144675649|SUPERIORITY|||||||0.001|||||||Kruskal-Wallis|||||||0.001
72574657|NCT05502081|144675649|SUPERIORITY|||||||0.004|||||||Kruskal-Wallis|||||||0.004
72574658|NCT05502081|144675650|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|||||||<0.001
72574659|NCT05502081|144675650|SUPERIORITY|||||||0.51|||||||Kruskal-Wallis|||||||0.51
72574660|NCT05502081|144675650|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|||||||<0.001
72574661|NCT05502081|144675650|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|||||||<0.001
72574662|NCT05502081|144675651|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|||||||<0.001
72574663|NCT05502081|144675651|SUPERIORITY|||||||0.891|||||||Kruskal-Wallis|||||||0.891
72574664|NCT05502081|144675651|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|||||||<0.001
72574665|NCT05502081|144675651|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|||||||<0.001
72574666|NCT05502081|144675652|SUPERIORITY|||||||0.516|||||||Kruskal-Wallis|||||||0.516
72574667|NCT05502081|144675653|SUPERIORITY|||||||0.264|||||||Wilcoxon (Mann-Whitney)|||||||0.264
72574668|NCT05502081|144675654|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|||||||<0.001
72574669|NCT05502081|144675654|SUPERIORITY|||||||0.256|||||||Kruskal-Wallis|||||||0.256
72574670|NCT05502081|144675654|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|||||||<0.001
72574671|NCT05502081|144675654|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|||||||<0.001
72538278|NCT03692078|144605816|EQUIVALENCE|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 7. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|-1.019|||<|0.0001|TWO_SIDED|95.0|-1.242|-0.796|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 7. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 7. (mITT Population)||-0.796|-1.242|<.0001
72574672|NCT05502081|144675655|SUPERIORITY|||||||0.008|||||||Kruskal-Wallis|||||||0.008
72574673|NCT05502081|144675655|SUPERIORITY|||||||0.797|||||||Kruskal-Wallis|||||||0.797
72574674|NCT05502081|144675655|SUPERIORITY|||||||0.003|||||||Kruskal-Wallis|||||||0.003
72574675|NCT05502081|144675655|SUPERIORITY|||||||0.004|||||||Kruskal-Wallis|||||||0.004
72574676|NCT05502081|144675656|SUPERIORITY|||||||0.157|||||||Wilcoxon (Mann-Whitney)|||||||0.157
72574677|NCT05502081|144675657|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|||||||<0.001
72574678|NCT05502081|144675657|SUPERIORITY|||||||0.982|||||||Kruskal-Wallis|||||||0.982
72574679|NCT05502081|144675657|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|||||||<0.001
72574680|NCT05502081|144675657|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|||||||<0.001
72574681|NCT05502081|144675658|SUPERIORITY|||||||0.015|||||||Kruskal-Wallis|||||||0.015
72574682|NCT05502081|144675658|SUPERIORITY|||||||0.136|||||||Kruskal-Wallis|||||||0.136
72574683|NCT05502081|144675658|SUPERIORITY|||||||0.062|||||||Kruskal-Wallis|||||||0.062
72574684|NCT05502081|144675658|SUPERIORITY|||||||0.005|||||||Kruskal-Wallis|||||||0.005
72574685|NCT05502081|144675659|SUPERIORITY|||||||0.136|||||||Wilcoxon (Mann-Whitney)|||||||0.136
72574686|NCT05502081|144675660|SUPERIORITY|||||||0.687|||||||Kruskal-Wallis|||||||0.687
72574687|NCT05502081|144675661|SUPERIORITY|||||||0.278|||||||Kruskal-Wallis|||||||0.278
72574688|NCT05502081|144675662|SUPERIORITY|||||||0.99|||||||Wilcoxon (Mann-Whitney)|||||||0.99
72574689|NCT05502081|144675663|SUPERIORITY|||||||0.574|||||||Kruskal-Wallis|||||||0.574
72574690|NCT05502081|144675664|SUPERIORITY|||||||0.017|||||||Kruskal-Wallis|||||||0.017
72574691|NCT05502081|144675664|SUPERIORITY|||||||0.017|||||||Kruskal-Wallis|||||||0.017
72574692|NCT05502081|144675664|SUPERIORITY|||||||0.041|||||||Kruskal-Wallis|||||||0.041
72574693|NCT05502081|144675664|SUPERIORITY|||||||0.616|||||||Kruskal-Wallis|||||||0.616
72574694|NCT05502081|144675665|SUPERIORITY|||||||0.99|||||||Kruskal-Wallis|||||||0.99
72574695|NCT05502081|144675666|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|||||||<0.001
72574696|NCT05502081|144675666|SUPERIORITY|||||||0.208|||||||Kruskal-Wallis|||||||0.208
72574697|NCT05502081|144675666|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|||||||<0.001
72574698|NCT05502081|144675666|SUPERIORITY|||||||0.001|||||||Kruskal-Wallis|||||||0.001
72574699|NCT05502081|144675667|SUPERIORITY|||||||0.088|||||||Kruskal-Wallis|||||||0.088
72574700|NCT05502081|144675668|SUPERIORITY|||||||0.157|||||||Wilcoxon (Mann-Whitney)|||||||0.157
72574701|NCT05502081|144675669|SUPERIORITY|||||||0.006|||||||Kruskal-Wallis|||||||0.006
72574702|NCT05502081|144675669|SUPERIORITY|||||||0.151|||||||Kruskal-Wallis|||||||0.151
72574703|NCT05502081|144675669|SUPERIORITY|||||||0.001|||||||Kruskal-Wallis|||||||0.001
72574704|NCT05502081|144675669|SUPERIORITY|||||||0.035|||||||Kruskal-Wallis|||||||0.035
72574705|NCT05502081|144675670|SUPERIORITY|||||||0.037|||||||Kruskal-Wallis|||||||0.037
72574706|NCT05502081|144675670|SUPERIORITY|||||||0.997|||||||Kruskal-Wallis|||||||0.997
72574707|NCT05502081|144675670|SUPERIORITY|||||||0.016|||||||Kruskal-Wallis|||||||0.016
72574708|NCT05502081|144675670|SUPERIORITY|||||||0.014|||||||Kruskal-Wallis|||||||0.014
72574709|NCT05502081|144675671|SUPERIORITY|||||||0.48|||||||Wilcoxon (Mann-Whitney)|||||||0.48
72574710|NCT05502081|144675672|SUPERIORITY|||||||0.047|||||||Kruskal-Wallis|||||||0.047
72574711|NCT05502081|144675672|SUPERIORITY|||||||0.04|||||||Kruskal-Wallis|||||||0.04
72574712|NCT05502081|144675672|SUPERIORITY|||||||0.036|||||||Kruskal-Wallis|||||||0.036
72574713|NCT05502081|144675672|SUPERIORITY|||||||0.67|||||||Kruskal-Wallis|||||||0.67
72574714|NCT05502081|144675673|SUPERIORITY|||||||0.015|||||||Kruskal-Wallis|||||||0.015
72574715|NCT05502081|144675673|SUPERIORITY|||||||0.027|||||||Kruskal-Wallis|||||||0.027
72574716|NCT05502081|144675673|SUPERIORITY|||||||0.008|||||||Kruskal-Wallis|||||||0.008
72574717|NCT05502081|144675673|SUPERIORITY|||||||0.38|||||||Kruskal-Wallis|||||||0.38
72574718|NCT05502081|144675674|SUPERIORITY|||||||0.814|||||||Kruskal-Wallis|||||||0.814
72574719|NCT05502081|144675675|SUPERIORITY|||||||0.157|||||||Wilcoxon (Mann-Whitney)|||||||0.157
72574720|NCT05502081|144675676|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|||||||<0.001
72574721|NCT05502081|144675676|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|||||||<0.001
72574722|NCT05502081|144675676|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|||||||<0.001
72574723|NCT05502081|144675676|SUPERIORITY|||||||0.971|||||||Kruskal-Wallis|||||||0.971
72574724|NCT05502081|144675677|SUPERIORITY|||||||0.001|||||||Kruskal-Wallis|||||||0.001
72574725|NCT05502081|144675677|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|||||||<0.001
72574726|NCT05502081|144675678|SUPERIORITY|||||||0.007|||||||Kruskal-Wallis|||||||0.007
72574727|NCT05502081|144675678|SUPERIORITY|||||||0.017|||||||Kruskal-Wallis|||||||0.017
72574728|NCT05502081|144675678|SUPERIORITY|||||||0.452|||||||Kruskal-Wallis|||||||0.452
72574729|NCT05502081|144675678|SUPERIORITY|||||||0.237|||||||Kruskal-Wallis|||||||0.237
72538279|NCT03692078|144605816|EQUIVALENCE|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 5. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|-1.172|||<|0.0001|TWO_SIDED|95.0|-1.358|-0.986|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 5. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 5. (mITT Population)||-0.986|-1.358|<.0001
72538280|NCT03692078|144605816|EQUIVALENCE|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 7. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|-1.196|||<|0.0001|TWO_SIDED|95.0|-1.409|-0.983|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 7. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 7. (mITT Population)||-0.983|-1.409|<.0001
72538281|NCT03692078|144605816|EQUIVALENCE|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 5. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|-1.049|||<|0.0001|TWO_SIDED|95.0|-1.239|-0.859|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 5. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 5. (mITT Population)||-0.859|-1.239|<.0001
72574730|NCT05502081|144675679|SUPERIORITY|||||||0.157|||||||Wilcoxon (Mann-Whitney)|||||||0.157
72574731|NCT05502081|144675680|SUPERIORITY|||||||0.015|||||||Kruskal-Wallis|||||||0.015
72574732|NCT05502081|144675680|SUPERIORITY|||||||0.223|||||||Kruskal-Wallis|||||||0.223
72574733|NCT05502081|144675680|SUPERIORITY|||||||0.004|||||||Kruskal-Wallis|||||||0.004
72574734|NCT05502081|144675680|SUPERIORITY|||||||0.05|||||||Kruskal-Wallis|||||||0.05
72574735|NCT05502081|144675681|SUPERIORITY|||||||0.423|||||||Kruskal-Wallis|||||||0.423
72574736|NCT05502081|144675682|SUPERIORITY|||||||0.429|||||||Wilcoxon (Mann-Whitney)|||||||0.429
72409393|NCT02391948|144327207|OTHER||Odds Ratio (OR)|0.93|||||TWO_SIDED|95.0|0.72|1.21|||||Country was included as a model covariate. OR represents the odds of children developing 'better than expected' (top 10%) vs 'as expected' (central 80%) for each unit change in parents' perception of needs being met.|Logistic regression comparing children progressing better than expected to those progressing as expected on the Child Engagement in Daily Life -Self Care outcome for the predictor amount of occupational therapy.||1.21|.72|
72574737|NCT05502081|144675683|SUPERIORITY|||||||0.089|||||||Kruskal-Wallis|||||||0.089
72574738|NCT05502081|144675684|SUPERIORITY|||||||0.222|||||||Kruskal-Wallis|||||||0.222
72574739|NCT05502081|144675685|SUPERIORITY|||||||0.252|||||||Kruskal-Wallis|||||||0.252
72574740|NCT05502081|144675686|SUPERIORITY|||||||0.157|||||||Wilcoxon (Mann-Whitney)|||||||0.157
72574741|NCT05502081|144675687|SUPERIORITY|||||||0.007|||||||Kruskal-Wallis|||||||0.007
72574742|NCT05502081|144675687|SUPERIORITY|||||||0.382|||||||Kruskal-Wallis|||||||0.382
72574743|NCT05502081|144675687|SUPERIORITY|||||||0.017|||||||Kruskal-Wallis|||||||0.017
72574744|NCT05502081|144675687|SUPERIORITY|||||||0.002|||||||Kruskal-Wallis|||||||0.002
72574745|NCT05502081|144675688|SUPERIORITY|||||||0.457|||||||Kruskal-Wallis|||||||0.457
72574746|NCT05502081|144675689|SUPERIORITY|||||||0.48|||||||Wilcoxon (Mann-Whitney)|||||||0.48
72574747|NCT05502081|144675690|SUPERIORITY|||||||0.01|||||||Kruskal-Wallis|||||||0.01
72574748|NCT05502081|144675690|SUPERIORITY|||||||0.605|||||||Kruskal-Wallis|||||||0.605
72574749|NCT05502081|144675690|SUPERIORITY|||||||0.003|||||||Kruskal-Wallis|||||||0.003
72574750|NCT05502081|144675690|SUPERIORITY|||||||0.01|||||||Kruskal-Wallis|||||||0.01
72574751|NCT05502081|144675691|SUPERIORITY|||||||0.293|||||||Kruskal-Wallis|||||||0.293
72574752|NCT05502081|144675692|SUPERIORITY|||||||0.157|||||||Wilcoxon (Mann-Whitney)|||||||0.157
72574753|NCT05502081|144675693|SUPERIORITY|||||||0.36|||||||Kruskal-Wallis|||||||0.36
72574754|NCT05502081|144675694|SUPERIORITY|||||||0.404|||||||Kruskal-Wallis|||||||0.404
72574755|NCT05502081|144675695|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|||||||<0.001
72574756|NCT05502081|144675695|SUPERIORITY|||||||0.234|||||||Kruskal-Wallis|||||||0.234
72574757|NCT05502081|144675695|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|||||||<0.001
72574758|NCT05502081|144675695|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|||||||<0.001
72574759|NCT05502081|144675696|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|||||||<0.001
72574760|NCT05502081|144675696|SUPERIORITY|||||||0.223|||||||Kruskal-Wallis|||||||0.223
72574761|NCT05502081|144675696|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|||||||<0.001
72574762|NCT05502081|144675696|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|||||||<0.001
72574763|NCT05502081|144675697|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|||||||<0.001
72574764|NCT05502081|144675697|SUPERIORITY|||||||0.002|||||||Kruskal-Wallis|||||||0.002
72574765|NCT05502081|144675697|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|||||||<0.001
72574766|NCT05502081|144675697|SUPERIORITY|||||||0.213|||||||Kruskal-Wallis|||||||0.213
72574767|NCT05502081|144675698|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|||||||<0.001
72574768|NCT05502081|144675698|SUPERIORITY|||||||0.478|||||||Kruskal-Wallis|||||||0.478
72574769|NCT05502081|144675698|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|||||||<0.001
72574770|NCT05502081|144675698|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|||||||<0.001
72574771|NCT05502081|144675699|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|||||||<0.001
72574772|NCT05502081|144675699|SUPERIORITY|||||||0.413|||||||Kruskal-Wallis|||||||0.413
72574773|NCT05502081|144675699|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|||||||<0.001
72574774|NCT05502081|144675699|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|||||||<0.001
72574775|NCT05502081|144675700|SUPERIORITY|||||||0.005|||||||Kruskal-Wallis|||||||0.005
72574776|NCT05502081|144675700|SUPERIORITY|||||||0.155|||||||Kruskal-Wallis|||||||0.155
72574777|NCT05502081|144675700|SUPERIORITY|||||||0.022|||||||Kruskal-Wallis|||||||0.022
72574778|NCT05502081|144675700|SUPERIORITY|||||||0.001|||||||Kruskal-Wallis|||||||0.001
72574779|NCT05502081|144675701|SUPERIORITY|||||||0.48|||||||Wilcoxon (Mann-Whitney)|||||||0.48
72574780|NCT05502081|144675702|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|||||||<0.001
72574781|NCT05502081|144675702|SUPERIORITY|||||||0.003|||||||Kruskal-Wallis|||||||0.003
72574782|NCT05502081|144675702|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|||||||<0.001
72574783|NCT05502081|144675702|SUPERIORITY|||||||0.011|||||||Kruskal-Wallis|||||||0.011
72574784|NCT05502081|144675703|SUPERIORITY|||||||0.189|||||||Kruskal-Wallis|||||||0.189
72574785|NCT05502081|144675704|SUPERIORITY|||||||0.414|||||||Wilcoxon (Mann-Whitney)|||||||0.414
72574786|NCT00176423|144675705|SUPERIORITY||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
72574787|NCT00176423|144675706|SUPERIORITY||||||<|0.05|||||||ANCOVA|||||||<0.05
72574788|NCT00176423|144675707|SUPERIORITY||||||<|0.05|||||||ANCOVA|||||||<0.05
72574789|NCT00176423|144675708|SUPERIORITY||||||<|0.05|||||||ANCOVA|||||||<0.05
72574790|NCT01755767|144675726|SUPERIORITY|||||||0.8006|||||||Log Rank|Stratified log rank between treatment arms adjusted for stratification factors: vascular invasion, extra-hepatic spread, and alpha fetoprotein level.||||||0.8006
72574791|NCT01755767|144675726|SUPERIORITY||Hazard Ratio (HR)|0.9682||||0.8061|TWO_SIDED|95.0|0.7483|1.2529|||Regression, Cox|Stratified Cox Regression between treatment arms adjusted for factors: vascular invasion, extra-hepatic spread, and alpha fetoprotein level.||||1.2529|0.7483|0.8061
72574792|NCT01755767|144675728|SUPERIORITY|||||||0.7509|||||||Log Rank|Stratified log rank between treatment arms adjusted for stratification factors: vascular invasion, extra-hepatic spread, and alpha fetoprotein level.||||||0.7509
72574793|NCT01755767|144675728|SUPERIORITY||Hazard Ratio (HR)|0.9557||||0.716|TWO_SIDED|95.0|0.7487|1.22|||Regression, Cox|Stratified Cox regression between treatment arms adjusted for factors: vascular invasion, extra-hepatic spread, and alpha fetoprotein level.||||1.2200|0.7487|0.7160
72574794|NCT00191165|144675731|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.45||||0.34||95.0|-0.5|1.4|||ANOVA||Mean Difference = High Dose - Label Dose|||1.40|-0.50|0.340
72574795|NCT00191165|144675732|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.16||||0.388||95.0|-0.21|0.53||P-value for 12-Month Height SDS Change|ANOVA||Mean Difference = High Dose - Label Dose|||0.53|-0.21|0.388
72574796|NCT00191165|144675732|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.49||||0.061||95.0|-0.02|0.99||P-value for 24-Month Height SDS Change|ANOVA||Mean Difference = High Dose - Label Dose|||0.99|-0.02|0.061
72574797|NCT00191165|144675733|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.13||||0.088||95.0|-0.18|2.44|||ANOVA||Mean Difference = High Dose - Label Dose|||2.44|-0.18|0.088
72574798|NCT00998309|144675740|SUPERIORITY_OR_OTHER||||||=|0.001|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Gender. The null hypothesis is there is no difference between males and females in the participatns of responders."||||=0.001
72574799|NCT00998309|144675741|SUPERIORITY_OR_OTHER||||||=|1|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Age. The null hypothesis is there is no difference between \<65 years and \>=65 years  in the participatns of responders."||||=1.000
72574800|NCT00998309|144675742|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was type of infection. The null hypothesis is there is no difference amang Skin and Soft Tissue Infection, Sexual Transmitted Infection, and Dental and Oral Surgery Infection in the participatns of responders."||||<0.001
72574801|NCT00998309|144675743|SUPERIORITY_OR_OTHER||||||=|0.556|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Infection severity. The null hypothesis is there is no difference amang mild infection, moderate infection, and severe infection in the participatns of responders."||||=0.556
72574802|NCT00998309|144675744|SUPERIORITY_OR_OTHER||||||=|0.074|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was hepatic dysfunction. The null hypothesis is there is no difference between with and without hepatic dysfunction in the participatns of responders."||||=0.074
72574803|NCT00998309|144675745|SUPERIORITY_OR_OTHER||||||=|1|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Renal dysfunction. The null hypothesis is there is no difference between with and without Renal dysfunction in the participatns of responders."||||=1.000
72574804|NCT00998309|144675746|SUPERIORITY_OR_OTHER||||||=|1|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Past medical history. The null hypothesis is there is no difference between with and without past medical history in the participatns of responders."||||=1.000
72574805|NCT00998309|144675747|SUPERIORITY_OR_OTHER||||||=|1|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was complications. The null hypothesis is there is no difference between with and without complications  in the participatns of responders."||||=1.000
72574806|NCT00998309|144675748|SUPERIORITY_OR_OTHER||||||=|1|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was previous antibiotic treatment history. The null hypothesis is there is no difference between with and without previous antibiotic treatment history in the participatns of responders."||||=1.000
72574807|NCT00998309|144675749|SUPERIORITY_OR_OTHER||||||=|0.47|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was comcomittant drugs. The null hypothesis is there is no difference between with and without comcomittant drugs in the participatns of responders."||||=0.470
72574808|NCT00998309|144675750|SUPERIORITY_OR_OTHER||||||=|1|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was non-drug therapy. The null hypothesis is there is no difference between with and without non-drug therapy in the participatns of responders."||||=1.000
72574809|NCT00998309|144675753|SUPERIORITY_OR_OTHER||||||=|0.657|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Gender. The null hypothesis is there is no difference between males and females in the Incidence Rate of Treatment Related Adverse Events (TRAEs)."||||=0.657
72409394|NCT02391948|144327207|OTHER||Odds Ratio (OR)|1.15|||||TWO_SIDED|95.0|0.89|1.5|||||Country was included as a model covariate. OR represents the odds of children developing 'better than expected' (top 10%) vs 'as expected' (central 80%) for each unit change in parents' perception of needs being met.|Logistic regression comparing children progressing better than expected to those progressing as expected on the Early Clinical Assessment of Balance outcome for the predictor amount of occupational therapy.||1.5|.89|
72409395|NCT02391948|144327207|OTHER||Odds Ratio (OR)|0.95|||||TWO_SIDED|95.0|0.65|1.38|||||Country was included as a model covariate. OR represents the odds of children developing 'better than expected' (top 10%) vs 'as expected' (central 80%) for each unit change in parents' perception of needs being met.|Logistic regression comparing children progressing better than expected to those progressing as expected on the Six Minute Walk Test outcome for the predictor amount of occupational therapy.||1.38|.65|
72409396|NCT02391948|144327207|OTHER||Odds Ratio (OR)|1.03|||||TWO_SIDED|95.0|0.81|1.31|||||Country was included as a model covariate. OR represents the odds of children developing 'better than expected' (top 10%) vs 'as expected' (central 80%) for each unit change in parents' perception of needs being met.|Logistic regression comparing children progressing better than expected to those progressing as expected on the Child Engagement in Daily Life - Self Care outcome for the predictor amount of speech and language therapy.||1.31|.81|
72409397|NCT02391948|144327207|OTHER||Odds Ratio (OR)|1.1|||||TWO_SIDED|95.0|0.87|1.39|||||Country was included as a model covariate. OR represents the odds of children developing 'better than expected' (top 10%) vs 'as expected' (central 80%) for each unit change in parents' perception of needs being met.|Logistic regression comparing children progressing better than expected to those progressing as expected on the Early Clinical Assessment of Balance outcome for the predictor amount of speech and language therapy.||1.39|.87|
72409398|NCT02391948|144327207|OTHER||Odds Ratio (OR)|0.86|||||TWO_SIDED|95.0|0.6|1.25|||||Country was included as a model covariate. OR represents the odds of children developing 'better than expected' (top 10%) vs 'as expected' (central 80%) for each unit change in parents' perception of needs being met.|Logistic regression comparing children progressing better than expected to those progressing as expected on the Six Minute Walk Test outcome for the predictor amount of speech and language therapy.||1.25|.6|
72409399|NCT02391948|144327207|OTHER||Odds Ratio (OR)|1.19|||||TWO_SIDED|95.0|0.92|1.53|||||Country was included as a model covariate. OR represents the odds of children developing 'better than expected' (top 10%) vs 'as expected' (central 80%) for each unit change in parents' perception of needs being met.|Logistic regression comparing children progressing better than expected to those progressing as expected on the Early Clinical Assessment of Balance outcome for the predictor amount of physical therapy services.||1.53|.92|
72538282|NCT03692078|144605816|EQUIVALENCE|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 7. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|-1.2|||<|0.0001|TWO_SIDED|95.0|-1.414|-0.986|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 7. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 7. (mITT Population)||-0.986|-1.414|<.0001
72574810|NCT00998309|144675754|SUPERIORITY_OR_OTHER||||||=|0.145|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Age. The null hypothesis is there is no difference between \<65 years or \>=65 in the Incidence Rate of Treatment Related Adverse Events (TRAEs)."||||=0.145
72409400|NCT02391948|144327211|OTHER||population average|2319.0|||||TWO_SIDED|95.0|1460.0|3218.0||||||The outcome was modelled as a function of age using a linear mixed effects model, and the population value at age 12 years was estimated from the model.||3218|1460|
72409401|NCT02391948|144327211|OTHER||population average|1858.0|||||TWO_SIDED|95.0|1233.0|2530.0||||||The outcome was modelled as a function of age using a linear mixed effects model, and the population value at age 12 years was estimated from the model.||2530|1233|
72409402|NCT02391948|144327212|OTHER||population average|5240.0|||||TWO_SIDED|95.0|3874.0|6670.0||||||The outcome was modelled as a function of age using a linear mixed effects model, and the population value at age 12 years was estimated from the model.||6670|3874|
72409403|NCT02391948|144327212|OTHER||population average|4319.0|||||TWO_SIDED|95.0|3258.0|5443.0||||||The outcome was modelled as a function of age using a linear mixed effects model, and the population value at age 12 years was estimated from the model.||5443|3258|
72409404|NCT02391948|144327213|OTHER||population average|108.0|||||TWO_SIDED|95.0|67.0|151.0||||||The outcome was modelled as a function of age using a linear mixed effects model, and the population value at age 12 years was estimated from the model.||151|67|
72409405|NCT02391948|144327213|OTHER||population average|100.0|||||TWO_SIDED|95.0|58.0|145.0||||||The outcome was modelled as a function of age using a linear mixed effects model, and the population value at age 12 years was estimated from the model.||145|58|
72409406|NCT02391948|144327213|OTHER||population average|10.0|||||TWO_SIDED|95.0|0.0|35.0||||||The outcome was modelled as a function of age using a linear mixed effects model, and the population value at age 12 years was estimated from the model. This analysis combined children in GMFCS Levels III-V.||35|0|
72409407|NCT02391948|144327214|OTHER||population average|2815.0|||||TWO_SIDED|95.0|2025.0|3650.0||||||The outcome was modelled as a function of age using a linear mixed effects model, and the population value at age 12 years was estimated from the model.||3650|2025|
72409408|NCT02391948|144327214|OTHER||population average|3109.0|||||TWO_SIDED|95.0|2502.0|3739.0||||||The outcome was modelled as a function of age using a linear mixed effects model, and the population value at age 12 years was estimated from the model.||3739|2502|
72409409|NCT02391948|144327214|OTHER||population average|1056.0|||||TWO_SIDED|95.0|471.0|1665.0||||||The outcome was modelled as a function of age using a linear mixed effects model, and the population value at age 12 years was estimated from the model. This analysis combined children in GMFCS Levels III-V.||1665|471|
72409410|NCT01602315|144327233|SUPERIORITY_OR_OTHER_LEGACY||median HR|0.99||||||||||||||The hazard ratio was estimated using the Bayesian Cox proportional hazard (PH) model.||||
72409411|NCT01602315|144327233|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.12||||0.643|TWO_SIDED|95.0|0.69|1.82|||Regression, Cox|||||1.82|0.69|0.643
72409412|NCT01602315|144327233|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.54||||0.039|TWO_SIDED|95.0|0.3|0.97|||Regression, Cox|||Adjusted on Covariates: treatment, sum of longest diameters from central data \[SLD (C)\], Hemaglobin (Hgb) and White Blood Cells (WBC).||0.97|0.30|0.039
72409413|NCT01602315|144327236|SUPERIORITY_OR_OTHER_LEGACY||Kaplan-Meier method (median)|43.0|||||TWO_SIDED|95.0|27.0|88.0|||||days|||88.0|27.0|
72409414|NCT01602315|144327242|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.28||||0.313|TWO_SIDED|95.0|0.79|2.05|||Regression, Cox|||||2.05|0.79|0.313
72409415|NCT01602315|144327243|SUPERIORITY_OR_OTHER_LEGACY||Kaplan-Meier (median)|294.0|||||TWO_SIDED|95.0|172.0|463.0||||||||463.0|172.0|
72574811|NCT00998309|144675755|SUPERIORITY_OR_OTHER||||||=|0.005|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Type of Infection. The null hypothesis is there is no difference amang Skin and Soft Tissue Infection, Sexual Transmitted Infection, and Dental or Oral Surgery Infection in the Incidence Rate of Treatment Related Adverse Events (TRAEs)."||||=0.005
72538283|NCT03692078|144605816|EQUIVALENCE|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 5. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|-1.337|||<|0.0001|TWO_SIDED|95.0|-1.574|-1.099|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 5. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 5. (mITT Population)||-1.099|-1.574|<.0001
72538284|NCT03692078|144605816|EQUIVALENCE|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 7. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|-1.345|||<|0.0001|TWO_SIDED|95.0|-1.616|-1.075|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 7. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 7. (mITT Population)||-1.075|-1.616|<.0001
72574812|NCT00998309|144675756|SUPERIORITY_OR_OTHER||||||=|0.213|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Infection severity. The null hypothesis is there is no difference amang mild infection, moderate infection, or severe infection in the Incidence Rate of Treatment Related Adverse Events (TRAEs)."||||=0.213
72574813|NCT00998309|144675757|SUPERIORITY_OR_OTHER||||||=|1|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Hepatic Dysfunction. The null hypothesis is there is no difference between with and without Hepatic Dysfunction in the Incidence Rate of Treatment Related Adverse Events (TRAEs)."||||=1.000
72574814|NCT00998309|144675758|SUPERIORITY_OR_OTHER||||||=|0.116|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Renal Dysfunction. The null hypothesis is there is no difference between with and without Renal Dysfunction in the Incidence Rate of Treatment Related Adverse Events (TRAEs)."||||=0.116
72574815|NCT00998309|144675759|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Past Medical History. The null hypothesis is there is no difference between with and without Past Medical History in the Incidence Rate of Treatment Related Adverse Events (TRAEs)."||||<0.001
72574816|NCT00998309|144675760|SUPERIORITY_OR_OTHER||||||=|0.645|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was complications. The null hypothesis is there is no difference between with and without complications in the Incidence Rate of Treatment Related Adverse Events (TRAEs)."||||=0.645
72409416|NCT01602315|144327257|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.76||||0.235|TWO_SIDED|95.0|0.49|1.19|||Regression, Cox|||||1.19|0.49|0.235
72409417|NCT01602315|144327257|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.64||||0.062|TWO_SIDED|95.0|0.4|1.02|||Regression, Cox|||Adjusted on Covariates: treatment, sum of longest diameters from local data \[SLD (L)\], Hemaglobin (Hgb) and White Blood Cells (WBC).||1.02|0.4|0.062
72409418|NCT01174030|144327285|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|8.392|||<|0.001||95.0|2.637|26.71|||GEE:Logit link function|Generalized Estimating Equation (GEE) methods with Logit link function and marginal expectation model.||||26.710|2.637|<0.001
72409419|NCT01174030|144327285|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.269||||0.549||95.0|0.586|2.747|||GEE:Logit link function|Generalized Estimating Equation (GEE) methods with Logit link function and marginal expectation model.||||2.747|0.586|0.549
72409420|NCT01174030|144327285|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|3.738||||0.027||95.0|1.097|12.742|||GEE:Logit link function|Generalized Estimating Equation (GEE) methods with Logit link function and marginal expectation model.||||12.742|1.097|0.027
72409421|NCT01174030|144327286|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.683||||0.003||95.0|1.388|5.188|||GEE:Logit link Function|Generalized Estimating Equation (GEE) methods with Logit link function and marginal expectation model||||5.188|1.388|.003
72409422|NCT01174030|144327286|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.892||||0.056||95.0|0.98|3.651|||GEE: Logit link Function|Generalized Estimating Equation (GEE) methods with Logit link function and marginal expectation model.||||3.651|0.980|0.056
72409423|NCT01174030|144327286|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.885||||0.074||95.0|0.946|3.756|||GEE:Logit link Function|Generalized Estimating Equation (GEE) methods with Logit link function and marginal expectation model.||||3.756|0.946|0.074
72409424|NCT01174030|144327287|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|6.582|||<|0.001||95.0|2.755|15.723|||GEE: Logit link function|Generalize Estimating Equation (GEE) methods with Logit link function and marginal expectation model.||||15.723|2.755|<0.001
72409425|NCT01174030|144327287|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.853||||0.093||95.0|0.903|3.802|||GEE: Logit link function|Generalized Estimating Equation (GEE) methods with Logit link function and marginal expectation model.||||3.802|0.903|0.093
72409426|NCT01174030|144327287|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.365||||0.054||95.0|0.96|5.825|||GEE: Logit link function|Generalized Estimating Equation (GEE) methods with Logit link function and marginal expectation model.||||5.825|0.960|0.054
72409427|NCT04713748|144327300|OTHER||||||<|0.0001|||||||Interclass correlation coefficient|||||||<0.0001
72538285|NCT03692078|144605816|EQUIVALENCE|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 5. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|-1.452|||<|0.0001|TWO_SIDED|95.0|-1.685|-1.219|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 5. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 5. (mITT Population)||-1.219|-1.685|<.0001
72538286|NCT03692078|144605816|EQUIVALENCE|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 7. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|-1.339|||<|0.0001|TWO_SIDED|95.0|-1.608|-1.071|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 7. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 7. (mITT Population)||-1.071|-1.608|<.0001
72538287|NCT03692078|144605816|EQUIVALENCE|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 5. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|-1.348|||<|0.0001|TWO_SIDED|95.0|-1.577|-1.118|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 5. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 5. (mITT Population)||-1.118|-1.577|<.0001
72538288|NCT03692078|144605816|EQUIVALENCE|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 7. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|-1.227|||<|0.0001|TWO_SIDED|95.0|-1.488|-0.966|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 7. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 7. (mITT Population)||-0.966|-1.488|<.0001
72538289|NCT03692078|144605816|EQUIVALENCE|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 5. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-0.224||||0.5646|TWO_SIDED|95.0|-0.607|0.16|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 5. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 5. (mITT Population)||0.160|-0.607|0.5646
72538290|NCT03692078|144605816|EQUIVALENCE|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 7. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-0.177||||0.8765|TWO_SIDED|95.0|-0.609|0.254|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 7. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 7. (mITT Population)||0.254|-0.609|0.8765
72538291|NCT03692078|144605816|EQUIVALENCE|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 5. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-0.101||||0.9954|TWO_SIDED|95.0|-0.488|0.287|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 5. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 5. (mITT Population)||0.287|-0.488|0.9954
72538292|NCT03692078|144605816|EQUIVALENCE|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 7. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-0.181||||0.8665|TWO_SIDED|95.0|-0.613|0.252|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 7. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 7. (mITT Population)||0.252|-0.613|0.8665
72538293|NCT03692078|144605816|EQUIVALENCE|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 5. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-0.389||||0.1165|TWO_SIDED|95.0|-0.829|0.052|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 5. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 5. (mITT Population)||0.052|-0.829|0.1165
72574817|NCT00998309|144675761|SUPERIORITY_OR_OTHER||||||=|0.679|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was previous antibiotic treatment history (PATH). The null hypothesis is there is no difference between with and without previous antibiotic treatment history (PTH) in the Incidence Rate of Treatment Related Adverse Events (TRAEs)."||||=0.679
72574818|NCT00998309|144675762|SUPERIORITY_OR_OTHER||||||=|0.234|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was comcomittant drugs. The null hypothesis is there is no difference between with and without comcomittant drugs in the Incidence Rate of Treatment Related Adverse Events (TRAEs)."||||=0.234
72574819|NCT00998309|144675763|SUPERIORITY_OR_OTHER||||||=|0.039|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was non-drug therapy. The null hypothesis is there is no difference between with and without non-drug therapy in the Incidence Rate of Treatment Related Adverse Events (TRAEs)."||||=0.039
72574820|NCT00998309|144675764|SUPERIORITY_OR_OTHER||||||=|0.605|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Pregnancy in Female. The null hypothesis is there is no difference between with and without Pregnancy in the Incidence Rate of Treatment Related Adverse Events (TRAEs) in Female."||||=0.605
72574821|NCT00555152|144675799|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Fisher Exact|||||||1
72574822|NCT04558918|144675802|SUPERIORITY||Odds Ratio (OR)|338.25|||<|0.0001|TWO_SIDED|95.0|25.07|4564.14||two sided unadjusted p-value|Regression, Logistic|Logistic regression model using Firth||||4564.14|25.07|<0.0001
72574823|NCT04558918|144675802|SUPERIORITY||Difference in marginal proportion|80.2|||||TWO_SIDED|95.0|71.2|87.6||||||||87.6|71.2|
72574824|NCT04558918|144675803|SUPERIORITY||Odds Ratio (OR)|495.74|||<|0.0001|TWO_SIDED|95.0|24.41|10066.53||two sided unadjusted p-value|Regression, Logistic|Logistic regression model using Firth||||10066.53|24.41|<0.0001
72538294|NCT03692078|144605816|EQUIVALENCE|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 7. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-0.326||||0.3896|TWO_SIDED|95.0|-0.821|0.168|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 7. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 7. (mITT Population)||0.168|-0.821|0.3896
72538295|NCT03692078|144605816|EQUIVALENCE|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 5. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-0.504||||0.0122|TWO_SIDED|95.0|-0.934|-0.074|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 5. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 5. (mITT Population)||-0.074|-0.934|0.0122
72574825|NCT04558918|144675803|SUPERIORITY||Diff. in marginal proportion|67.0|||||TWO_SIDED|95.0|56.4|76.9||||||||76.9|56.4|
72574826|NCT04558918|144675806|OTHER||Adjusted mean difference|-0.01|||||TWO_SIDED|95.0|-0.53|0.51||||||||0.51|-0.53|
72574827|NCT04558918|144675807|OTHER||Adjusted mean difference|-1.17|||||TWO_SIDED|95.0|-4.01|1.68||||||||1.68|-4.01|
72574828|NCT04558918|144675808|SUPERIORITY||Odds Ratio (OR)|108.41|||<|0.0001|TWO_SIDED|95.0|17.25|681.24||two sided unadjusted p-value|Conditional logistic regression|||||681.24|17.25|<0.0001
72574829|NCT04558918|144675808|SUPERIORITY||Diff. in marginal proportion|68.9|||||TWO_SIDED|95.0|51.4|83.9||||||logistic regression model||83.9|51.4|
72574830|NCT04558918|144675809|SUPERIORITY||Adjusted mean diff.|3.66|||<|0.0001|TWO_SIDED|95.0|3.2|4.12||two sided unadjusted p-value|Mixed Model of Repeated Measures (MMRM)|||||4.12|3.20|<0.0001
72574831|NCT04558918|144675810|SUPERIORITY||Mean Difference (Net)|8.29|||<|0.0001|TWO_SIDED|95.0|5.28|11.29||two sided unadjusted p-value|Mixed Model of Repeated Measures (MMRM)|||||11.29|5.28|<0.0001
72574832|NCT04558918|144675811|SUPERIORITY||Mean Difference (Net)|-116.15|||<|0.0001|TWO_SIDED|95.0|-132.04|-100.26||two sided unadjusted p-value|Mixed Model of Repeated Measures (MMRM)|||||-100.26|-132.04|<0.0001
72574833|NCT04558918|144675812|SUPERIORITY||Geometric mean ratio|0.99||||0.8361|TWO_SIDED|95.0|0.89|1.1||two sided unadjusted p-value|Mixed Model of Repeated Measures (MMRM)|||||1.10|0.89|0.8361
72574834|NCT04558918|144675813|SUPERIORITY||Rate ratio|0.1||||0.01183|TWO_SIDED|95.0|0.02|0.61||two sided unadjusted p-value|Negative binomial model|||||0.61|0.02|0.01183
72574835|NCT04558918|144675813|SUPERIORITY||Rate difference|-0.6|||||TWO_SIDED|95.0|-1.24|0.04||||||||0.04|-1.24|
72574836|NCT04558918|144675814|SUPERIORITY||rate difference|0.03||||0.31731|TWO_SIDED|95.0|-0.03|0.1||two sided unadjusted p-value|Poisson model|||||0.10|-0.03|0.31731
72574837|NCT04558918|144675815|OTHER||Adjusted mean difference|1.69|||||TWO_SIDED|95.0|-16.86|20.23||||||||20.23|-16.86|
72574838|NCT04558918|144675816|OTHER||Geometric mean ratio|1.12|||||TWO_SIDED|95.0|0.97|1.3||||||||1.30|0.97|
72574839|NCT02737748|144675852|OTHER|||||||0.2217|||||||Cochran-Mantel-Haenszel|||||||0.2217
72574840|NCT02737748|144675853|OTHER|||||||0.0324|||||||Cochran-Mantel-Haenszel|||||||0.0324
72574841|NCT02737748|144675854|OTHER|||||||0.3975|||||||Log Rank|||||||0.3975
72574842|NCT01292226|144675903|SUPERIORITY_OR_OTHER|||||||0.4505||||||Free MPA, time 0 \[trough\]|ANOVA|Analysis of variance (ANOVA)||||||0.4505
72574843|NCT01292226|144675903|SUPERIORITY_OR_OTHER|||||||0.7322||||||Free MPA, time 120 \[2 hours after administration at Week 12\]|ANOVA|||||||0.7322
72574844|NCT01292226|144675903|SUPERIORITY_OR_OTHER|||||||0.6798||||||Total MPA, time 0 \[trough\]|ANOVA|||||||0.6798
72574845|NCT01292226|144675903|SUPERIORITY_OR_OTHER|||||||0.541||||||Total MPA, time 120 \[2 hours after administration at Week 12\]|ANOVA|||||||0.5410
72574846|NCT01292226|144675904|SUPERIORITY_OR_OTHER|||||||0.3892||||||Free MPA, time 0 \[trough\]|ANOVA|||||||0.3892
72574847|NCT01292226|144675904|SUPERIORITY_OR_OTHER|||||||0.6564||||||Total MPA, time 0 \[trough\]|ANOVA|||||||0.6564
72574848|NCT01292226|144675904|SUPERIORITY_OR_OTHER|||||||0.7772||||||Free MPA, time 120 \[2 hours after administration at Week 12\]|ANOVA|||||||0.7772
72574849|NCT01292226|144675904|SUPERIORITY_OR_OTHER|||||||0.0958||||||Total MPA, time 120 \[2 hours after administration at Week 12\]|ANOVA|||||||0.0958
72574850|NCT01292226|144675905|SUPERIORITY_OR_OTHER|||||||0.5796||||||Time 0 \[trough\]|ANOVA|||||||0.5796
72574851|NCT01292226|144675905|SUPERIORITY_OR_OTHER|||||||0.3428||||||Time 120 \[2 hours after administration at Week 12\]|ANOVA|||||||0.3428
72574852|NCT01292226|144675906|SUPERIORITY_OR_OTHER|||||||0.9372||||||Free MPA, time 0 \[trough\]|ANOVA|||||||0.9372
72574853|NCT01292226|144675906|SUPERIORITY_OR_OTHER|||||||0.9904||||||Total MPA, time 0 \[trough\]|ANOVA|||||||0.9904
72409428|NCT00113516|144327302|SUPERIORITY_OR_OTHER||probability|0.405|||||TWO_SIDED|90.0|0.315|0.494|||Kaplan-Meier||The probability of survival along with the corresponding confidence interval (CI) (for the log \[-log (1-year survival rate)\]) was calculated using a normal approximation and then back transformed to give a CI for the 1-year survival rate itself.|The study was designed to test the null hypothesis that the true one-year probability of survival is 0.40 versus the alternative hypothesis that the true one-year probability of survival is at least 0.55. The sample size was determined using a One-Sample Survival design, assuming alpha=0.05 (1-sided), power= 0.90, 6 month accrual, a minimum follow-up period of 12 months, and an expectation that approximately 5% of subjects may be lost to follow-up.||0.494|0.315|
72409429|NCT00113516|144327306|SUPERIORITY_OR_OTHER||Objective Response Rate (ORR) (percent)|27.4|||||TWO_SIDED|95.0|18.2|38.2||||||||38.2|18.2|
72409430|NCT00113516|144327320|SUPERIORITY_OR_OTHER|||||||0.474||95.0|||||Wilcoxon Rank Sum Test|||||||0.474
72409431|NCT00113516|144327321|SUPERIORITY_OR_OTHER|||||||0.836||95.0|||||Wilcoxon Rank Sum Test|||Cycle 1, Day 28||||0.836
72409432|NCT00113516|144327321|SUPERIORITY_OR_OTHER|||||||0.071||95.0|||||Wilcoxon Rank Sum Test|||Cycle 2, Day 1||||0.071
72409433|NCT00113516|144327321|SUPERIORITY_OR_OTHER|||||||0.393||95.0|||||Wilcoxon Rank Sum Test|||Cycle 2, Day 28||||0.393
72538296|NCT03692078|144605816|EQUIVALENCE|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 7. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-0.32||||0.3938|TWO_SIDED|95.0|-0.807|0.167|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 7. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 7. (mITT Population)||0.167|-0.807|0.3938
72574854|NCT01292226|144675906|SUPERIORITY_OR_OTHER|||||||0.3658||||||Free MPA, time 120 \[2 hours after administration at Week 12\]|ANOVA|||||||0.3658
72574855|NCT01292226|144675906|SUPERIORITY_OR_OTHER|||||||0.2987||||||Total MPA, time 120 \[2 hours after administration at Week 12\]|ANOVA|||||||0.2987
72409434|NCT00113516|144327321|SUPERIORITY_OR_OTHER|||||||0.029||95.0|||||Wilcoxon Rank Sum Test|||Cycle 3, Day 1||||0.029
72409435|NCT00113516|144327321|SUPERIORITY_OR_OTHER|||||||0.247||95.0|||||Wilcoxon Rank Sum Test|||Cycle 3, Day 28||||0.247
72409436|NCT00113516|144327322|SUPERIORITY_OR_OTHER|||||||0.305||95.0|||||Wilcoxon Rank Sum Test|||||||0.305
72409437|NCT00113516|144327323|SUPERIORITY_OR_OTHER|||||||0.738||95.0|||||Wilcoxon Rank Sum Test|||Cycle 1, Day 28||||0.738
72409438|NCT00113516|144327323|SUPERIORITY_OR_OTHER|||||||0.438||95.0|||||Wilcoxon Rank Sum Test|||Cycle 2, Day 1||||0.438
72409439|NCT00113516|144327323|SUPERIORITY_OR_OTHER|||||||0.236||95.0|||||Wilcoxon Rank Sum Test|||Cycle 2, Day 28||||0.236
72409440|NCT00113516|144327323|SUPERIORITY_OR_OTHER|||||||0.287||95.0|||||Wilcoxon Rank Sum Test|||Cycle 3, Day 1||||0.287
72409441|NCT00113516|144327323|SUPERIORITY_OR_OTHER|||||||0.772||95.0|||||Wilcoxon Rank Sum Test|||Cycle 3, Day 28||||0.772
72409442|NCT00113516|144327324|SUPERIORITY_OR_OTHER|||||||0.537||95.0|||||Wilcoxon Rank Sum Test|||||||0.537
72409443|NCT00113516|144327325|SUPERIORITY_OR_OTHER|||||||0.813||95.0|||||Wilcoxon Rank Sum Test|||Cycle 1, Day 28||||0.813
72409444|NCT00113516|144327325|SUPERIORITY_OR_OTHER|||||||0.849||95.0|||||Wilcoxon Rank Sum Test|||Cycle 2, Day 1||||0.849
72409445|NCT00113516|144327325|SUPERIORITY_OR_OTHER|||||||0.121||95.0|||||Wilcoxon Rank Sum Test|||Cycle 2, Day 28||||0.121
72409446|NCT00113516|144327325|SUPERIORITY_OR_OTHER|||||||0.582||95.0|||||Wilcoxon Rank Sum Test|||Cycle 3, Day 1||||0.582
72409447|NCT00113516|144327325|SUPERIORITY_OR_OTHER|||||||0.383||95.0|||||Wilcoxon Rank Sum Test|||Cycle 3, Day 28||||0.383
72409448|NCT00113516|144327326|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.1||||0.6782|TWO_SIDED|95.0|0.61|2.15|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group.|Cycle 1, Day 1||2.15|0.61|0.6782
72409449|NCT00113516|144327326|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.6||||0.198|TWO_SIDED|95.0|0.77|3.3|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group.|Cycle 1, Day 28||3.30|0.77|0.1980
72409450|NCT00113516|144327326|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.8||||0.1344|TWO_SIDED|95.0|0.82|3.98|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group.|Cycle 2, Day 1||3.98|0.82|0.1344
72409451|NCT00113516|144327326|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.4||||0.4809|TWO_SIDED|95.0|0.56|3.39|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group.|Cycle 2, Day 28||3.39|0.56|0.4809
72409452|NCT00113516|144327326|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|3.6||||0.0153|TWO_SIDED|95.0|1.19|11.13|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group|Cycle 3, Day 1||11.13|1.19|0.0153
72409453|NCT00113516|144327326|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.7||||0.2085|TWO_SIDED|95.0|0.52|14.37|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group|Cycle 3, Day 28||14.37|0.52|0.2085
72409454|NCT00113516|144327326|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.4||||0.8084|TWO_SIDED|95.0|0.08|23.57|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group|Cycle 5, Day 28||23.57|0.08|0.8084
72409455|NCT00113516|144327327|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.2||||0.507|TWO_SIDED|95.0|0.65|2.39|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group.|Cycle 1, Day 1||2.39|0.65|0.5070
72409456|NCT00113516|144327327|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.3||||0.4474|TWO_SIDED|95.0|0.63|2.82|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group.|Cycle 1, Day 28||2.82|0.63|0.4474
72409457|NCT00113516|144327327|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.9||||0.7599|TWO_SIDED|95.0|0.4|1.95|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group.|Cycle 2, Day 1||1.95|0.40|0.7599
72574856|NCT01292226|144675907|SUPERIORITY_OR_OTHER|||||||0.7455||||||time 0 \[trough\]|ANOVA|||||||0.7455
72574857|NCT01292226|144675907|SUPERIORITY_OR_OTHER|||||||0.8504||||||Time 120 \[2 hours after administration at Week 12\]|ANOVA|||||||0.8504
72574858|NCT01292226|144675908|SUPERIORITY_OR_OTHER|||||||0.6847||||||IMPDH I, time 0 \[trough\]|ANOVA|||||||0.6847
72538297|NCT03692078|144605816|EQUIVALENCE|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 5. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|0.176||||0.8501|TWO_SIDED|95.0|-0.237|0.589|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 5. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 5. (mITT Population)||0.589|-0.237|0.8501
72538298|NCT03692078|144605816|EQUIVALENCE|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 7. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|0.031||||1|TWO_SIDED|95.0|-0.435|0.496|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 7. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 7. (mITT Population)||0.496|-0.435|1.0000
72538299|NCT03692078|144605816|EQUIVALENCE|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 5. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|0.299||||0.2928|TWO_SIDED|95.0|-0.117|0.715|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 5. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 5. (mITT Population)||0.715|-0.117|0.2928
72409458|NCT00113516|144327327|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.3||||0.0109|TWO_SIDED|95.0|0.12|0.8|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group.|Cycle 2, Day 28||0.80|0.12|0.0109
72538300|NCT03692078|144605816|EQUIVALENCE|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 7. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|0.027||||1|TWO_SIDED|95.0|-0.439|0.493|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 7. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 7. (mITT Population)||0.493|-0.439|1.0000
72538301|NCT03692078|144605816|EQUIVALENCE|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 5. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|0.011||||1|TWO_SIDED|95.0|-0.453|0.475|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 5. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 5. (mITT Population)||0.475|-0.453|1.0000
72538302|NCT03692078|144605816|EQUIVALENCE|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 7. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|-0.118||||0.9966|TWO_SIDED|95.0|-0.64|0.403|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 7. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 7. (mITT Population)||0.403|-0.640|0.9966
72538303|NCT03692078|144605816|EQUIVALENCE|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 5. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|-0.104||||0.9976|TWO_SIDED|95.0|-0.56|0.352|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 5. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 5. (mITT Population)||0.352|-0.560|0.9976
72538304|NCT03692078|144605816|EQUIVALENCE|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 7. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|-0.112||||0.9976|TWO_SIDED|95.0|-0.628|0.404|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 7. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 7. (mITT Population)||0.404|-0.628|0.9976
72574859|NCT01292226|144675908|SUPERIORITY_OR_OTHER|||||||0.3184||||||IMPDH I, time 120 \[2 hours after administration at Week 12\]|ANOVA|||||||0.3184
72574860|NCT01292226|144675908|SUPERIORITY_OR_OTHER|||||||0.3862||||||IMPDH II, time 0 \[trough\]|ANOVA|||||||0.3862
72409459|NCT00113516|144327327|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.2||||0.6878|TWO_SIDED|95.0|0.43|3.58|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group.|Cycle 3, Day 1||3.58|0.43|0.6878
72409460|NCT00113516|144327327|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.7||||0.4637|TWO_SIDED|95.0|0.38|8.12|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group.|Cycle 3, Day 28||8.12|0.38|0.4637
72409461|NCT00113516|144327328|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.8||||0.5277|TWO_SIDED|95.0|0.39|1.62|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group.|Cycle 1, Day 1||1.62|0.39|0.5277
72409462|NCT00113516|144327328|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.4||||0.466|TWO_SIDED|95.0|0.58|3.29|||Log Rank||HR was based upon the ratio of \>=Median Cutpoint group hazard to \<Median Cutpoint group.|Cycle 1, Day 28||3.29|0.58|0.4660
72538305|NCT03692078|144605818|EQUIVALENCE|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 1 is equal to zero on Day 5. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 1 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|180.0|||<|0.0001|TWO_SIDED|95.0|164.9|195.2|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 1 is equal to zero on Day 5. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 1 is NOT equal to zero on Day 5. (mITT Population)||195.2|164.9|<.0001
72538306|NCT03692078|144605818|EQUIVALENCE|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 1 is equal to zero on Day 7. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 1 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|181.1|||<|0.0001|TWO_SIDED|95.0|165.9|196.2|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 1 is equal to zero on Day 7. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 1 is NOT equal to zero on Day 7. (mITT Population)||196.2|165.9|<.0001
72538307|NCT03692078|144605818|EQUIVALENCE|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 2 is equal to zero on Day 5. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 2 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|132.3|||<|0.0001|TWO_SIDED|95.0|117.2|147.5|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 2 is equal to zero on Day 5. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 2 is NOT equal to zero on Day 5. (mITT Population)||147.5|117.2|<.0001
72538308|NCT03692078|144605818|EQUIVALENCE|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 2 is equal to zero on Day 7. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 2 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|137.3|||<|0.0001|TWO_SIDED|95.0|122.1|152.5|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 2 is equal to zero on Day 7. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 2 is NOT equal to zero on Day 7. (mITT Population)||152.5|122.1|<.0001
72574861|NCT01292226|144675908|SUPERIORITY_OR_OTHER|||||||0.904||||||IMPDH II, time 120 \[2 hours after administration at Week 12\]|ANOVA|||||||0.9040
72574862|NCT01292226|144675908|SUPERIORITY_OR_OTHER|||||||0.0907||||||IMPDH activity, time 0 \[trough\]|ANOVA|||||||0.0907
72574863|NCT01292226|144675908|SUPERIORITY_OR_OTHER|||||||0.963||||||IMPDH activity, time 120 \[2 hours after administration at Week 12\]|ANOVA|||||||0.9630
72574864|NCT01292226|144675909|SUPERIORITY_OR_OTHER|||||||0.413||||||IMPDH I|ANOVA|||||||0.4130
72574865|NCT01292226|144675909|SUPERIORITY_OR_OTHER|||||||0.3823||||||IMPDH II|ANOVA|||||||0.3823
72574866|NCT01292226|144675910|SUPERIORITY_OR_OTHER|||||||0.0316||||||IMPDH I|ANOVA|||||||0.0316
72574867|NCT01292226|144675910|SUPERIORITY_OR_OTHER|||||||0.944||||||IMPDH II|ANOVA|||||||0.9440
72574868|NCT01292226|144675911|SUPERIORITY_OR_OTHER|||||||0.1328||||||IMPDH I|ANOVA|||||||0.1328
72409463|NCT00113516|144327328|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.3||||0.5337|TWO_SIDED|95.0|0.52|3.44|||Log Rank||HR was based upon the ratio of \>=Median Cutpoint group hazard to \<Median Cutpoint group.|Cycle 2, Day 1||3.44|0.52|0.5337
72409464|NCT00113516|144327328|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.4||||0.0712|TWO_SIDED|95.0|0.13|1.13|||Log Rank||HR was based upon the ratio of \>=Median Cutpoint group hazard to \<Median Cutpoint group.|Cycle 2, Day 28||1.13|0.13|0.0712
72409465|NCT00113516|144327328|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.0||||0.2948|TWO_SIDED|95.0|0.54|7.07|||Log Rank||HR was based upon the ratio of \>=Median Cutpoint group hazard to \<Median Cutpoint group.|Cycle 3, Day 1||7.07|0.54|0.2948
72409466|NCT00113516|144327328|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|3.3||||0.32|TWO_SIDED|95.0|0.28|38.48|||Log Rank||HR was based upon the ratio of \>=Median Cutpoint group hazard to \<Median Cutpoint group.|Cycle 3, Day 28||38.48|0.28|0.3200
72574869|NCT01292226|144675911|SUPERIORITY_OR_OTHER|||||||0.576||||||IMPDH II|ANOVA|||||||0.5760
72574870|NCT01292226|144675912|SUPERIORITY_OR_OTHER|||||||0.7332||||||Free MPA|ANOVA|||||||0.7332
72574871|NCT01292226|144675912|SUPERIORITY_OR_OTHER|||||||0.2681||||||Total MPA|ANOVA|||||||0.2681
72574872|NCT01292226|144675912|SUPERIORITY_OR_OTHER|||||||0.7087||||||AUC MPA|ANOVA|||||||0.7087
72574873|NCT01292226|144675913|SUPERIORITY_OR_OTHER|||||||0.9432||||||Free MPA|ANOVA|||||||0.9432
72574874|NCT01292226|144675913|SUPERIORITY_OR_OTHER|||||||0.5177||||||Total MPA|ANOVA|||||||0.5177
72574875|NCT01292226|144675913|SUPERIORITY_OR_OTHER|||||||0.6398||||||AUC MPA|ANOVA|||||||0.6398
72574876|NCT01292226|144675914|SUPERIORITY_OR_OTHER|||||||0.0656||||||Free MPA|ANOVA|||||||0.0656
72574877|NCT01292226|144675914|SUPERIORITY_OR_OTHER|||||||0.0131||||||Total MPA|ANOVA|||||||0.0131
72574878|NCT01292226|144675914|SUPERIORITY_OR_OTHER|||||||0.0515||||||AUC MPA|ANOVA|||||||0.0515
72574879|NCT01844505|144675917|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.57|||<|0.0001|TWO_SIDED|99.5|0.43|0.76|||Stratified Log Rank test||Stratified Cox proportional hazard model. Ratio of Nivolumab over Ipimlimumab.|||0.76|0.43|<0.0001
72574880|NCT01844505|144675917|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.42|||<|0.0001|TWO_SIDED|99.5|0.31|0.57|||Stratified Log Rank test||Stratified Cox proportional hazard model. Ratio of Nivolumab+Ipilimumab over Ipilimumab.|||0.57|0.31|<0.0001
72574881|NCT01844505|144675918|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.63|||<|0.0001|TWO_SIDED|98.0|0.5|0.78|||Log Rank|Log-rank Test stratified by PD-L1 status, BRAF status, and M stage at screening as entered into the Interactive Voice Response System (IVRS).|Stratified Cox proportional hazard model. Ratio of Nivolumab over Ipilimumab|||0.78|0.50|<0.0001
72574882|NCT01844505|144675918|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.55|||<|0.0001|TWO_SIDED|98.0|0.42|0.72|||Log Rank|Log-rank Test stratified by PD-L1 status, BRAF status, and M stage at screening as entered into the IVRS.|Stratified Cox proportional hazard model. Ratio of Nivolumab+Ipilimumab over Ipilimumab.|||0.72|0.42|<0.0001
72574883|NCT01844505|144675921|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.79|||||TWO_SIDED|95.0|0.65|0.96|||||Stratified Cox proportional hazard model. Hazard Ratio is Nivolumab + Ipilimumab over Nivolumab.|||0.96|0.65|
72574884|NCT01844505|144675922|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.85|||||TWO_SIDED|95.0|0.69|1.05|||||Stratified Cox proportional hazard model. Hazard Ratio is Nivolumab + Ipilimumab over Nivolumab.|||1.05|0.69|
72574885|NCT01844505|144675923|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|3.59|||<|0.0001|TWO_SIDED|95.0|2.49|5.16|||Cochran-Mantel-Haenszel||Cochran-Mantel-Haenszel Test Stratified by PD-L1 Status, BRAF Status and M stage at screening as entered into the IVRS. Ratio of Nivolumab over Ipilimumab.|||5.16|2.49|<0.0001
72574886|NCT01844505|144675923|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|6.35|||<|0.0001|TWO_SIDED|95.0|4.38|9.22|||Cochran-Mantel-Haenszel||Cochran-Mantel-Haenszel Test Stratified by PD-L1 Status, BRAF Status and M stage at screening as entered into the IVRS. Ratio of Nivolumab + Ipilimumab over Ipilimumab.|||9.22|4.38|<0.0001
72574887|NCT01844505|144675923|SUPERIORITY_OR_OTHER_LEGACY||Difference of Objective Response Rates|26.0|||||TWO_SIDED|95.0|19.1|32.8|||||Difference in ORR and corresponding 95% CI is based on Cochran-Mantel-Haenszel (CMH) method of weighting, adjusting for PD-L1 Status, BRAF Mutation Status and M-stage at screening as entered into the IVRS. Difference of Nivolumab - Ipilimumab.|||32.8|19.1|
72574888|NCT01844505|144675923|SUPERIORITY_OR_OTHER_LEGACY||Difference of Objective Response Rates|39.0|||||TWO_SIDED|95.0|32.2|45.9|||||Difference in ORR and corresponding 95% CI is based on CMH method of weighting, adjusting for PD-L1 Status, BRAF Mutation Status and M-stage at screening as entered into the IVRS. Difference of Nivolumab and Ipilimumab - Ipilimumab.|||45.9|32.2|
72574889|NCT01844505|144675923|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.75|||||TWO_SIDED|95.0|1.26|2.42|||||Cochran-Mantel-Haenszel Test Stratified by PD-L1 Status, BRAF Status and M stage at screening as entered into the IVRS. Ratio of Nivolumab + Ipilimumab over Nivolumab|||2.42|1.26|
72574890|NCT01844505|144675923|SUPERIORITY_OR_OTHER_LEGACY||Difference of Objective Response Rates|13.2|||||TWO_SIDED|95.0|5.7|20.7|||||Difference in ORR and corresponding 95% CI is based on CMH method of weighting, adjusting for PD-L1 Status, BRAF Mutation Status and M-stage at screening as entered into the IVRS. Difference of Nivolumab and Ipilimumab - Nivolumab.|||20.7|5.7|
72574891|NCT01844505|144675924|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.63|||||TWO_SIDED|95.0|0.46|0.85|||||HR of Nivolumab vs. Ipilimumab in participants with PD-L1 expression \< 1%|||0.85|0.46|
72574892|NCT01844505|144675924|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.39|||||TWO_SIDED|95.0|0.28|0.54|||||HR of Nivolumab+Ipilimumab vs. Ipilimumab in participants with PD-L1 expression \< 1%|||0.54|0.28|
72574893|NCT01844505|144675924|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.63|||||TWO_SIDED|95.0|0.45|0.87|||||HR of Nivolumab+Ipilimumab vs. Nivolumab in participants with PD-L1 expression \< 1%|||0.87|0.45|
72574894|NCT01844505|144675924|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.45|||||TWO_SIDED|95.0|0.34|0.59|||||HR of Nivolumab vs. Ipilimumab in participants with PD-L1 expression \>= 1%|||0.59|0.34|
72574895|NCT01844505|144675924|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.4|||||TWO_SIDED|95.0|0.3|0.53|||||HR of Nivolumab+Ipilimumab vs. Ipilimumab in participants with PD-L1 expression \>= 1%|||0.53|0.30|
72574896|NCT01844505|144675924|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.9|||||TWO_SIDED|95.0|0.66|1.21|||||HR of Nivolumab+Ipilimumab vs. Nivolumab in participants with PD-L1 expression \>= 1%|||1.21|0.66|
72574897|NCT01844505|144675924|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.57|||||TWO_SIDED|95.0|0.45|0.71|||||HR of Nivolumab vs. Ipilimumab in participants with PD-L1 expression \< 5%|||0.71|0.45|
72574898|NCT01844505|144675924|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.42|||||TWO_SIDED|95.0|0.33|0.53|||||HR of Nivolumab+Ipilimumab vs. Ipilimumab in participants with PD-L1 expression \< 5%|||0.53|0.33|
72574899|NCT01844505|144675924|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.73|||||TWO_SIDED|95.0|0.57|0.94|||||HR of Nivolumab+Ipilimumab vs. Nivolumab in participants with PD-L1 expression \< 5%|||0.94|0.57|
72574900|NCT01844505|144675924|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.4|||||TWO_SIDED|95.0|0.27|0.6|||||HR of Nivolumab vs. Ipilimumab in participants with PD-L1 expression \>= 5%|||0.60|0.27|
72574901|NCT01844505|144675924|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.35|||||TWO_SIDED|95.0|0.22|0.54|||||HR of Nivolumab+Ipilimumab vs. Ipilimumab in participants with PD-L1 expression \>= 5%|||0.54|0.22|
72574902|NCT01844505|144675924|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.87|||||TWO_SIDED|95.0|0.54|1.38|||||HR of Nivolumab+Ipilimumab vs. Nivolumab in participants with PD-L1 expression \>= 5%|||1.38|0.54|
72574903|NCT01844505|144675924|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.54|||||TWO_SIDED|95.0|0.43|0.67|||||HR of Nivolumab vs. Ipilimumab in participants with PD-L1 expression \< 10%|||0.67|0.43|
72574904|NCT01844505|144675924|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.43|||||TWO_SIDED|95.0|0.34|0.54|||||HR of Nivolumab+Ipilimumab vs. Ipilimumab in participants with PD-L1 expression \< 10%|||0.54|0.34|
72574905|NCT01844505|144675924|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.8|||||TWO_SIDED|95.0|0.63|1.01|||||HR of Nivolumab+Ipilimumab vs. Nivolumab in participants with PD-L1 expression \< 10%|||1.01|0.63|
72574906|NCT01844505|144675924|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.46|||||TWO_SIDED|95.0|0.28|0.73|||||HR of Nivolumab vs. Ipilimumab in participants with PD-L1 expression \>= 10%|||0.73|0.28|
72574907|NCT01844505|144675924|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.28|||||TWO_SIDED|95.0|0.16|0.49|||||HR of Nivolumab+Ipilimumab vs. Ipilimumab in participants with PD-L1 expression \>= 10%|||0.49|0.16|
72574908|NCT01844505|144675924|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.61|||||TWO_SIDED|95.0|0.34|1.09|||||HR of Nivolumab+Ipilimumab vs. Nivolumab in participants with PD-L1 expression \>= 10%|||1.09|0.34|
72538309|NCT03692078|144605818|EQUIVALENCE|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 3 is equal to zero on Day 5. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 3 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|136.8|||<|0.0001|TWO_SIDED|95.0|122.0|151.7|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 3 is equal to zero on Day 5. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 3 is NOT equal to zero on Day 5. (mITT Population)||151.7|122.0|<.0001
72538310|NCT03692078|144605818|EQUIVALENCE|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 3 is equal to zero on Day 7. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 3 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|150.8|||<|0.0001|TWO_SIDED|95.0|136.0|165.7|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 3 is equal to zero on Day 7. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 3 is NOT equal to zero on Day 7. (mITT Population)||165.7|136.0|<.0001
72538311|NCT03692078|144605818|EQUIVALENCE|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 4 is equal to zero on Day 5. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 4 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|43.2|||<|0.0001|TWO_SIDED|95.0|25.1|61.4|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 4 is equal to zero on Day 5. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 4 is NOT equal to zero on Day 5. (mITT Population)||61.4|25.1|<.0001
72538312|NCT03692078|144605818|EQUIVALENCE|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 4 is equal to zero on Day 7. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 4 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|61.7|||<|0.0001|TWO_SIDED|95.0|43.2|80.1|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 4 is equal to zero on Day 7. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 4 is NOT equal to zero on Day 7. (mITT Population)||80.1|43.2|<.0001
72538313|NCT03692078|144605818|EQUIVALENCE|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 5 is equal to zero on Day 5. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 5 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|36.9|||<|0.0001|TWO_SIDED|95.0|18.6|55.1|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 5 is equal to zero on Day 5. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 5 is NOT equal to zero on Day 5. (mITT Population)||55.1|18.6|<.0001
72574909|NCT01844505|144675924|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.86|||||TWO_SIDED|95.0|0.49|1.52|||||HR of Nivolumab vs. Ipilimumab in participants with PD-L1 expression not evaluable at baseline|||1.52|0.49|
72574910|NCT01844505|144675924|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.51|||||TWO_SIDED|95.0|0.3|0.89|||||HR of Nivolumab+Ipilimumab vs. Ipilimumab in participants with PD-L1 expression not evaluable at baseline|||0.89|0.30|
72574911|NCT01844505|144675924|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.6|||||TWO_SIDED|95.0|0.33|1.09|||||HR of Nivolumab+Ipilimumab vs. Nivolumab in participants with PD-L1 expression not evaluable at baseline|||1.09|0.33|
72574912|NCT01844505|144675925|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.78|||||TWO_SIDED|95.0|0.57|1.05|||||HR of Nivolumab vs. Ipilimumab in participants with PD-L1 expression \< 1%|||1.05|0.57|
72574913|NCT01844505|144675925|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.59|||||TWO_SIDED|95.0|0.43|0.81|||||HR of Nivolumab+Ipilimumab vs. Ipilimumab in participants with PD-L1 expression \< 1%|||0.81|0.43|
72574914|NCT01844505|144675925|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.76||||||95.0|0.55|1.04|||||HR of Nivolumab+Ipilimumab vs. Nivolumab in participants with PD-L1 expression \< 1%|||1.04|0.55|
72574915|NCT01844505|144675925|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.52|||||TWO_SIDED|95.0|0.39|0.68|||||HR of Nivolumab vs. Ipilimumab in participants with PD-L1 expression \>= 1%|||0.68|0.39|
72574916|NCT01844505|144675925|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.5|||||TWO_SIDED|95.0|0.38|0.67|||||HR of Nivolumab+Ipilimumab vs. Ipilimumab in participants with PD-L1 expression \>= 1%|||0.67|0.38|
72574917|NCT01844505|144675925|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.97|||||TWO_SIDED|95.0|0.72|1.31|||||HR of Nivolumab+Ipilimumab vs. Nivolumab in participants with PD-L1 expression \>= 1%|||1.31|0.72|
72574918|NCT01844505|144675925|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.62|||||TWO_SIDED|95.0|0.49|0.78|||||HR of Nivolumab vs. Ipilimumab in participants with PD-L1 expression \< 5%|||0.78|0.49|
72574919|NCT01844505|144675925|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.52|||||TWO_SIDED|95.0|0.41|0.66|||||HR of Nivolumab+Ipilimumab vs. Ipilimumab in participants with PD-L1 expression \< 5%|||0.66|0.41|
72409467|NCT00113516|144327329|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.1||||0.7824|TWO_SIDED|95.0|0.56|2.17|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group.|Cycle 1, Day 1||2.17|0.56|0.7824
72409468|NCT00113516|144327329|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.6||||0.1918|TWO_SIDED|95.0|0.77|3.47|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group.|Cycle 1, Day 28||3.47|0.77|0.1918
72574920|NCT01844505|144675925|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.84|||||TWO_SIDED|95.0|0.66|1.08|||||HR of Nivolumab+Ipilimumab vs. Nivolumab in participants with PD-L1 expression \< 5%|||1.08|0.66|
72574921|NCT01844505|144675925|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.61|||||TWO_SIDED|95.0|0.41|0.91|||||HR of Nivolumab vs. Ipilimumab in participants with PD-L1 expression \>= 5%|||0.91|0.41|
72574922|NCT01844505|144675925|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.59|||||TWO_SIDED|95.0|0.38|0.91|||||HR of Nivolumab+Ipilimumab vs. Ipilimumab in participants with PD-L1 expression \>= 5%|||0.91|0.38|
72574923|NCT01844505|144675925|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.97|||||TWO_SIDED|95.0|0.62|1.53|||||HR of Nivolumab+Ipilimumab vs. Nivolumab in participants with PD-L1 expression \>= 5%|||1.53|0.62|
72627340|NCT05136170|144783682|SUPERIORITY||Adjusted means difference|0.164||||0.973|TWO_SIDED|95.0|-9.221|9.549||P-value of adjusted means difference between treatments from the ANCOVA model on change from baseline in SANDE score for frequency at Week 12.|ANCOVA|||Analysis was based on ANCOVA model with multiple imputation (MI) under missing not at random (MNAR) using retrieve dropouts with change from baseline in the frequency SANDE score at Week 12 as dependent variable, treatment, gender, age class and baseline frequency SANDE score as qualitative independent variables. Site was considered as random effects that vary randomly among patients.||9.549|-9.221|0.973
72627341|NCT05136170|144783683|SUPERIORITY|"Changes from baseline in each IDEEL modules scale score was analyzed using a mixed model for repeated measures (MMRM) adjusting by gender, age class, IDEEL module baseline value, treatment, visit and treatment by visit interaction. Subject was considered as a random effect. The covariance matrix used was unstructured. Comparisons vs vehicle TID were provided using least square means at each visit and overall."|LS means difference|2.378||||0.52|TWO_SIDED|95.0|-4.869|9.625||P-value of LS means difference between treatments from the MMRM on change from baseline in IDEEL Quality of Life Module (Daily Activities) at Week 4|Mixed Model for Repeated Measures|||QoL (Daily Activities) - Week 4||9.625|-4.869|0.52
72538314|NCT03692078|144605818|EQUIVALENCE|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 5 is equal to zero on Day 7. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 5 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|35.5||||0.0002|TWO_SIDED|95.0|16.7|54.3|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 5 is equal to zero on Day 7. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 5 is NOT equal to zero on Day 7. (mITT Population)||54.3|16.7|0.0002
72627342|NCT05136170|144783683|SUPERIORITY|"Changes from baseline in each IDEEL modules scale score was analyzed using a mixed model for repeated measures (MMRM) adjusting by gender, age class, IDEEL module baseline value, treatment, visit and treatment by visit interaction. Subject was considered as a random effect. The covariance matrix used was unstructured. Comparisons vs vehicle TID were provided using least square means at each visit and overall."|LS means difference|7.11||||0.073|TWO_SIDED|95.0|-0.653|14.873||P-value of LS means difference between treatments from the MMRM on change from baseline in IDEEL Quality of Life Module (Daily Activities) at Week 12.|Mixed Model for Repeated Measures|||QoL (Daily Activities) - Week 12||14.873|-0.653|0.073
72627343|NCT05136170|144783683|SUPERIORITY|"Changes from baseline in each IDEEL modules scale score was analyzed using a mixed model for repeated measures (MMRM) adjusting by gender, age class, IDEEL module baseline value, treatment, visit and treatment by visit interaction. Subject was considered as a random effect. The covariance matrix used was unstructured. Comparisons vs vehicle TID were provided using least square means at each visit and overall."|LS means difference|-4.166||||0.317|TWO_SIDED|95.0|-12.322|3.989||P-value of LS means difference between treatments from the MMRM on change from baseline in IDEEL Quality of Life Module (Feelings) at Week 4.|Mixed Model for Repeated Measures|||QoL (Feelings) - Week 4||3.989|-12.322|0.317
72538315|NCT03692078|144605818|EQUIVALENCE|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 6 is equal to zero on Day 5. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 6 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|38.8|||<|0.0001|TWO_SIDED|95.0|19.9|57.6|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 6 is equal to zero on Day 5. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 6 is NOT equal to zero on Day 5. (mITT Population)||57.6|19.9|<.0001
72538316|NCT03692078|144605818|EQUIVALENCE|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 6 is equal to zero on Day 7. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 6 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|44.9|||<|0.0001|TWO_SIDED|95.0|26.0|63.8|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 6 is equal to zero on Day 7. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 6 is NOT equal to zero on Day 7. (mITT Population)||63.8|26.0|<.0001
72409469|NCT00113516|144327329|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.9||||0.1093|TWO_SIDED|95.0|0.85|4.3|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group.|Cycle 2, Day 1||4.30|0.85|0.1093
72409470|NCT00113516|144327329|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.4||||0.4809|TWO_SIDED|95.0|0.56|3.39|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group.|Cycle 2, Day 28||3.39|0.56|0.4809
72574924|NCT01844505|144675925|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.6|||||TWO_SIDED|95.0|0.48|0.75|||||HR of Nivolumab vs. Ipilimumab in participants with PD-L1 expression \< 10%|||0.75|0.48|
72574925|NCT01844505|144675925|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.54|||||TWO_SIDED|95.0|0.43|0.68|||||HR of Nivolumab+Ipilimumab vs. Ipilimumab in participants with PD-L1 expression \< 10%|||0.68|0.43|
72574926|NCT01844505|144675925|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.9|||||TWO_SIDED|95.0|0.71|1.14|||||HR of Nivolumab+Ipilimumab vs. Nivolumab in participants with PD-L1 expression \< 10%|||1.14|0.71|
72409471|NCT00113516|144327329|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|4.2||||0.011|TWO_SIDED|95.0|1.26|13.85|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group.|Cycle 3, Day 1||13.85|1.26|0.0110
72409472|NCT00113516|144327329|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.7||||0.2085|TWO_SIDED|95.0|0.52|14.37|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group.|Cycle 3, Day 28||14.37|0.52|0.2085
72538317|NCT03692078|144605818|EQUIVALENCE|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 2 is equal to Group 1 on Day 5. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 2 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-47.7||||0.0002|TWO_SIDED|95.0|-78.0|-17.4|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 2 is equal to Group 1 on Day 5. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 2 is NOT equal to Group 1 on Day 5. (mITT Population)||-17.4|-78.0|0.0002
72538318|NCT03692078|144605818|EQUIVALENCE|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 2 is equal to Group 1 on Day 7. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 2 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-43.8||||0.0009|TWO_SIDED|95.0|-74.1|-13.4|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 2 is equal to Group 1 on Day 7. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 2 is NOT equal to Group 1 on Day 7. (mITT Population)||-13.4|-74.1|0.0009
72538319|NCT03692078|144605818|EQUIVALENCE|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 3 is equal to Group 1 on Day 5. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 3 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-43.2||||0.0009|TWO_SIDED|95.0|-73.2|-13.3|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 3 is equal to Group 1 on Day 5. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 3 is NOT equal to Group 1 on Day 5. (mITT Population)||-13.3|-73.2|0.0009
72538320|NCT03692078|144605818|EQUIVALENCE|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 3 is equal to Group 1 on Day 7. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 3 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-30.2||||0.0466|TWO_SIDED|95.0|-60.2|-0.3|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 3 is equal to Group 1 on Day 7. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 3 is NOT equal to Group 1 on Day 7. (mITT Population)||-0.3|-60.2|0.0466
72538321|NCT03692078|144605818|EQUIVALENCE|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 4 is equal to Group 1 on Day 5. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 4 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-136.8|||<|0.0001|TWO_SIDED|95.0|-170.4|-103.3|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 4 is equal to Group 1 on Day 5. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 4 is NOT equal to Group 1 on Day 5. (mITT Population)||-103.3|-170.4|<.0001
72574927|NCT01844505|144675925|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.69|||||TWO_SIDED|95.0|0.44|1.1|||||HR of Nivolumab vs. Ipilimumab in participants with PD-L1 expression \>= 10%|||1.10|0.44|
72574928|NCT01844505|144675925|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.54|||||TWO_SIDED|95.0|0.32|0.91|||||HR of Nivolumab+Ipilimumab vs. Ipilimumab in participants with PD-L1 expression \>= 10%|||0.91|0.32|
72574929|NCT01844505|144675925|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.77|||||TWO_SIDED|95.0|0.45|1.32|||||HR of Nivolumab+Ipilimumab vs. Nivolumab in participants with PD-L1 expression \>= 10%|||1.32|0.45|
72574930|NCT01844505|144675925|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.71|||||TWO_SIDED|95.0|0.37|1.34|||||HR of Nivolumab vs. Ipilimumab in participants with PD-L1 expression not evaluable at baseline|||1.34|0.37|
72574931|NCT01844505|144675925|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.48|||||TWO_SIDED|95.0|0.26|0.91|||||HR of Nivolumab+Ipilimumab vs. Ipilimumab in participants with PD-L1 expression not evaluable at baseline|||0.91|0.26|
72409473|NCT00113516|144327329|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.4||||0.8084|TWO_SIDED|95.0|0.08|23.57|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group.|Cycle 5, Day 28||23.57|0.08|0.8084
72409474|NCT00113516|144327330|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.3||||0.5215|TWO_SIDED|95.0|0.62|2.53|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group.|Cycle 1, Day 1||2.53|0.62|0.5215
72409475|NCT00113516|144327330|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.6||||0.2504|TWO_SIDED|95.0|0.72|3.49|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group.|Cycle 1, Day 28||3.49|0.72|0.2504
72409476|NCT00113516|144327330|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.9||||0.8766|TWO_SIDED|95.0|0.42|2.11|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group.|Cycle 2, Day 1||2.11|0.42|0.8766
72409477|NCT00113516|144327330|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.3||||0.0109|TWO_SIDED|95.0|0.12|0.8|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group.|Cycle 2, Day 28||0.80|0.12|0.0109
72409478|NCT00113516|144327330|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.4||||0.5627|TWO_SIDED|95.0|0.46|4.18|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group.|Cycle 3, Day 1||4.18|0.46|0.5627
72409479|NCT00113516|144327330|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.7||||0.4637|TWO_SIDED|95.0|0.38|8.12|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group.|Cycle 3, Day 28||8.12|0.38|0.4637
72538322|NCT03692078|144605818|EQUIVALENCE|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 4 is equal to Group 1 on Day 7. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 4 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-119.4|||<|0.0001|TWO_SIDED|95.0|-153.3|-85.5|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 4 is equal to Group 1 on Day 7. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 4 is NOT equal to Group 1 on Day 7. (mITT Population)||-85.5|-153.3|<.0001
72574932|NCT01844505|144675925|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.68|||||TWO_SIDED|95.0|0.34|1.39|||||HR of Nivolumab+Ipilimumab vs. Nivolumab in participants with PD-L1 expression not evaluable at baseline|||1.39|0.34|
72627344|NCT05136170|144783683|SUPERIORITY|"Changes from baseline in each IDEEL modules scale score was analyzed using a mixedmodel for repeated measures (MMRM) adjusting by gender, age class, IDEEL module baseline value, treatment, visit and treatment by visit interaction. Subject was considered as a random effect. The covariance matrix used was unstructured. Comparisons vs vehicle TID were provided using least square means at each visit and overall"|LS means difference|1.058||||0.792|TWO_SIDED|95.0|-6.786|8.901||P-value of LS means difference between treatments from the MMRM on change from baseline in IDEEL Quality of Life Module (Feelings) at Week 12.|Mixed Model for Repeated Measures|||QoL (Feelings) - Week 12||8.901|-6.786|0.792
72627345|NCT05136170|144783683|SUPERIORITY|"Changes from baseline in each IDEEL modules scale score was analyzed using a mixed model for repeated measures (MMRM). Analyses included the fixed, categorical effects of treatment, visit and treatment by visit interaction. Subject was considered as a random effect. The covariance matrix used was unstructured. Comparisons vs vehicle TID were provided using least square means at each visit and overall. Missing data will be imputed according to the questionnaire manuals"|LS means difference|-3.907||||0.488|TWO_SIDED|95.0|-14.948|7.135||P-value of LS means difference between treatments from the MMRM on change from baseline in IDEEL Quality of Life Module (Work) at Week 4.|Mixed Model for Repeated Measures|||QoL (Work) - Week 4||7.135|-14.948|0.488
72627346|NCT05136170|144783683|SUPERIORITY|"Changes from baseline in each IDEEL modules scale score was analyzed using a mixed model for repeated measures (MMRM) adjusting by gender, age class, IDEEL module baseline value, treatment, visit and treatment by visit interaction. Subject was considered as a random effect. The covariance matrix used was unstructured. Comparisons vs vehicle TID were provided using least square means at each visit and overall."|LS means difference|-0.284||||0.954|TWO_SIDED|95.0|-9.998|9.431||P-value of LS means difference between treatments from the MMRM on change from baseline in IDEEL Quality of Life Module (Work) at Week 12.|Mixed Model for Repeated Measures|||QoL (Work) - Week 12||9.431|-9.998|0.954
72574933|NCT00423319|144675944|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.36|||<|0.0001|TWO_SIDED|95.0|0.22|0.54||Statistically significant at the 1-sided 0.025 level|Farrington-Manning test||Apixaban-enoxaparin|||0.54|0.22|<0.0001
72574934|NCT00423319|144675944|SUPERIORITY_OR_OTHER||Risk Difference|-2.47|||<|0.0001|TWO_SIDED|95.0|-3.54|1.5||Statistically significant at the 1-sided 0.025 level|Farrington-Manning test||Apixaban-enoxaparin|||1.50|-3.54|<0.0001
72574935|NCT00423319|144675945|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.4|||<|0.0001|TWO_SIDED|95.0|0.15|0.8||Statistically significant at the 1-sided 0.025 level|Farrington-Manning test||Apixaban-enoxaparin|||0.80|0.15|<0.0001
72574936|NCT00423319|144675945|SUPERIORITY_OR_OTHER||Risk difference|-0.68||||0.0054|TWO_SIDED|95.0|-1.27|-0.17||Statistically significant at the 1-sided 0.025 level|Chi-squared||Apixaban-enoxaparin|||-0.17|-1.27|0.0054
72409480|NCT00113516|144327331|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.8||||0.6682|TWO_SIDED|95.0|0.39|1.84|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group.|Cycle 1, Day 1||1.84|0.39|0.6682
72409481|NCT00113516|144327331|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.2||||0.6854|TWO_SIDED|95.0|0.49|3.0|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group.|Cycle 1, Day 28||3.00|0.49|0.6854
72409482|NCT00113516|144327331|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.3||||0.6028|TWO_SIDED|95.0|0.49|3.37|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group.|Cycle 2, Day 1||3.37|0.49|0.6028
72409483|NCT00113516|144327331|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.4||||0.0712|TWO_SIDED|95.0|0.13|1.13|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group.|Cycle 2, Day 28||1.13|0.13|0.0712
72409484|NCT00113516|144327331|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.9||||0.3411|TWO_SIDED|95.0|0.5|7.15|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group.|Cycle 3, Day 1||7.15|0.50|0.3411
72574937|NCT00423319|144675947|SUPERIORITY_OR_OTHER||Difference in event rates|0.15||||0.54|TWO_SIDED|95.0|-0.33|0.64||2-sided P-Value|Chi-squared||Major bleeding. Apixaban-enoxaparin|||0.64|-0.33|0.54
72574938|NCT00423319|144675947|SUPERIORITY_OR_OTHER||Difference in event rates|-0.44||||0.43|TWO_SIDED|95.0|-1.53|0.66||2-sided P-Value|Chi-squared||CRNM. Apixaban-enoxaparin|||0.66|-1.53|0.43
72574939|NCT00423319|144675947|SUPERIORITY_OR_OTHER||Difference in event rates|-0.21||||0.72|TWO_SIDED|95.0|-1.38|0.95||2-sided P-Value|Chi-squared||Major or CRNM. Apixaban-enoxaparin|||0.95|-1.38|0.72
72574940|NCT00423319|144675947|SUPERIORITY_OR_OTHER||Difference in event rate|-0.85||||0.34|TWO_SIDED|95.0|-2.61|0.9||2-sided P-Value|Chi-squared||Any bleeding. Apixaban-enoxaparin|||0.90|-2.61|0.34
72574941|NCT00423319|144675957|SUPERIORITY_OR_OTHER||Difference in event rates|-0.04|||||TWO_SIDED|95.0|-0.34|0.26|||||Apixaban-enoxaparin. MI/stroke|||0.26|-0.34|
72538323|NCT03692078|144605818|EQUIVALENCE|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 5 is equal to Group 1 on Day 5. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 5 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-143.2|||<|0.0001|TWO_SIDED|95.0|-176.6|-109.7|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 5 is equal to Group 1 on Day 5. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 5 is NOT equal to Group 1 on Day 5. (mITT Population)||-109.7|-176.6|<.0001
72538324|NCT03692078|144605818|EQUIVALENCE|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 5 is equal to Group 1 on Day 7. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 5 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-145.6|||<|0.0001|TWO_SIDED|95.0|-179.7|-111.4|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 5 is equal to Group 1 on Day 7. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 5 is NOT equal to Group 1 on Day 7. (mITT Population)||-111.4|-179.7|<.0001
72538325|NCT03692078|144605818|EQUIVALENCE|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 2 is equal to Group 6 on Day 5. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 2 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|93.6|||<|0.0001|TWO_SIDED|95.0|60.0|127.2|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 2 is equal to Group 6 on Day 5. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 2 is NOT equal to Group 6 on Day 5. (mITT Population)||127.2|60.0|<.0001
72574942|NCT00423319|144675957|SUPERIORITY_OR_OTHER||Difference in event rates|0.07|||||TWO_SIDED|95.0|-0.17|0.34|||||Apixaban-enoxaparin. MI|||0.34|-0.17|
72574943|NCT00423319|144675957|SUPERIORITY_OR_OTHER||Difference in event rates|-0.11|||||TWO_SIDED|95.0|-0.35|0.07|||||Apixaban-enoxaparin. Stroke|||0.07|-0.35|
72574944|NCT00423319|144675957|SUPERIORITY_OR_OTHER||Difference in event rates|-0.04|||||TWO_SIDED|95.0|-0.26|0.17|||||Apixaban-enoxaparin. Thrombocytopenia|||0.17|-0.26|
72627347|NCT05136170|144783683|SUPERIORITY|"Changes from baseline in each IDEEL modules scale score was analyzed using a mixed model for repeated measures (MMRM) adjusting by gender, age class, IDEEl module baseline value, treatment, visit and treatment by visit interaction. Subject was considered as a random effect. The covariance matrix used was unstructured. Comparisons vs vehicle TID were provided using least square means at each visit and overall."|LS means difference|-0.049||||0.99|TWO_SIDED|95.0|-7.658|7.559||P-value of LS means difference between treatments from the MMRM on change from baseline in IDEEL DE Treatment Satisfaction \& Bother module (Satisfaction with Treatment Effectiveness) at Week 4.|Mixed Model for Repeated Measures|||TS (Treatment - in general) - Week 4||7.559|-7.658|0.99
72574945|NCT01584843|144675958|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.83||||0.091|TWO_SIDED|95.0|-21.81|2.14||LSD=Least Significant Difference|Fisher LSD method|||||2.14|-21.81|0.091
72574946|NCT01584843|144675958|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.08||||0.338|TWO_SIDED|95.0|-20.39|8.23|||Fisher LSD method|||||8.23|-20.39|0.338
72574947|NCT01584843|144675958|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.75||||0.524|TWO_SIDED|95.0|-9.83|17.33|||Fisher LSD method|||||17.33|-9.83|0.524
72574948|NCT01584843|144675958|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.85||||0.031|TWO_SIDED|95.0|-24.46|-1.24|||Fisher LSD method|||||-1.24|-24.46|0.031
72574949|NCT01584843|144675958|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.72||||0.005|TWO_SIDED|95.0|-28.06|-5.38|||Fisher LSD method|||||-5.38|-28.06|0.005
72574950|NCT01584843|144675958|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.87||||0.49|TWO_SIDED|95.0|-15.21|7.47|||Fisher LSD method|||||7.47|-15.21|0.490
72574951|NCT00311402|144675975|NON_INFERIORITY_OR_EQUIVALENCE|The non-event rates after 1 year in the Aggrenox group and ASA group are estimated at 94.0% and 91.5%, respectively. The non-inferiority margin was set to 2%. Under these conditions, 500 patients per group were supposed to be enough to detect the non-inferiority of Aggrenox with over 80% power.|Cox Proportional Hazard|1.47||||0.097||95.0|0.93|2.31|||Regression, Cox|||Non-event rate was calculated by using the Kaplan-Meier method and the comparison of groups was made by using the Cox proportional hazard regression model.||2.31|0.93|0.097
72574952|NCT00311402|144675976|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.79||||0.223||95.0|0.7|4.54|||Regression, Cox|||Non-event rate was calculated by using the Kaplan-Meier method and the comparison of groups was made by using the Cox proportional hazard regression model.||4.54|0.70|0.223
72574953|NCT00311402|144675977|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.0||||0.998|ONE_SIDED|95.0|0.0||||Regression, Cox|||Non-event rate was calculated by using the Kaplan-Meier method and the comparison of groups was made by using the Cox proportional hazard regression model.|||0|0.998
72574954|NCT00311402|144675978|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.02||||0.977||95.0|0.21|5.07|||Regression, Cox|||Non-event rate was calculated by using the Kaplan-Meier method and the comparison of groups was made by using the Cox proportional hazard regression model.||5.07|0.21|0.977
72574955|NCT00311402|144675979|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.58||||0.192||95.0|0.26|1.31|||Regression, Cox|||Non-event rate was calculated by using the Kaplan-Meier method and the comparison of groups was made by using the Cox proportional hazard regression model.||1.31|0.26|0.192
72409485|NCT00113516|144327331|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|3.3||||0.32|TWO_SIDED|95.0|0.28|38.48|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group.|Cycle 3, Day 28||38.48|0.28|0.3200
72409486|NCT00113516|144327332|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.2||||0.4768|TWO_SIDED|95.0|0.7|2.17|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group.|Cycle 1, Day 1||2.17|0.70|0.4768
72409487|NCT00113516|144327332|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.6||||0.1484|TWO_SIDED|95.0|0.84|3.13|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group.|Cycle 1, Day 28||3.13|0.84|0.1484
72538326|NCT03692078|144605818|EQUIVALENCE|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 2 is equal to Group 6 on Day 7. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 2 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|92.4|||<|0.0001|TWO_SIDED|95.0|58.8|126.1|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 2 is equal to Group 6 on Day 7. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 2 is NOT equal to Group 6 on Day 7. (mITT Population)||126.1|58.8|<.0001
72538327|NCT03692078|144605818|EQUIVALENCE|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 3 is equal to Group 6 on Day 5. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 3 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|98.1|||<|0.0001|TWO_SIDED|95.0|64.6|131.5|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 3 is equal to Group 6 on Day 5. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 3 is NOT equal to Group 6 on Day 5. (mITT Population)||131.5|64.6|<.0001
72538328|NCT03692078|144605818|EQUIVALENCE|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 3 is equal to Group 6 on Day 7. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 3 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|106.0|||<|0.0001|TWO_SIDED|95.0|72.5|139.4|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 3 is equal to Group 6 on Day 7. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 3 is NOT equal to Group 6 on Day 7. (mITT Population)||139.4|72.5|<.0001
72538329|NCT03692078|144605818|EQUIVALENCE|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 4 is equal to Group 6 on Day 5. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 4 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|4.5||||1|TWO_SIDED|95.0|-32.0|40.9|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 4 is equal to Group 6 on Day 5. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 4 is NOT equal to Group 6 on Day 5. (mITT Population)||40.9|-32.0|1.0000
72538330|NCT03692078|144605818|EQUIVALENCE|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 4 is equal to Group 6 on Day 7. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 4 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|16.8||||0.7714|TWO_SIDED|95.0|-20.0|53.5|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 4 is equal to Group 6 on Day 7. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 4 is NOT equal to Group 6 on Day 7. (mITT Population)||53.5|-20.0|0.7714
72574956|NCT00311402|144675980|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.88||||0.215||95.0|0.69|5.07|||Regression, Cox|||Non-event rate was calculated by using the Kaplan-Meier method and the comparison of groups was made by using the Cox proportional hazard regression model.||5.07|0.69|0.215
72574957|NCT00311402|144675981|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.16||||0.443||95.0|0.79|1.69|||Regression, Cox|||Non-event rate was calculated by using the Kaplan-Meier method and the comparison of groups was made by using the Cox proportional hazard regression model.||1.69|0.79|0.443
72574958|NCT00311402|144675982|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.52||||0.043||95.0|1.01|2.29|||Regression, Cox|||Non-event rate was calculated by using the Kaplan-Meier method and the comparison of groups was made by using the Cox proportional hazard regression model.||2.29|1.01|0.043
72409488|NCT00113516|144327332|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.1||||0.8957|TWO_SIDED|95.0|0.5|2.18|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group.|Cycle 2, Day 1||2.18|0.50|0.8957
72409489|NCT00113516|144327332|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.8||||0.5681|TWO_SIDED|95.0|0.33|1.85|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group.|Cycle 2, Day 28||1.85|0.33|0.5681
72409490|NCT00113516|144327332|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|3.8||||0.0074|TWO_SIDED|95.0|1.35|10.88|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group.|Cycle 3, Day 1||10.88|1.35|0.0074
72409491|NCT00113516|144327332|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.3||||0.1637|TWO_SIDED|95.0|0.06|1.7|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group.|Cycle 3, Day 28||1.70|0.06|0.1637
72409492|NCT00113516|144327332|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.6||||0.4328|TWO_SIDED|95.0|0.23|29.12|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group.|Cycle 5, Day 28||29.12|0.23|0.4328
72409493|NCT00113516|144327333|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.3||||0.4269|TWO_SIDED|95.0|0.72|2.21|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group.|Cycle 1, Day 1||2.21|0.72|0.4269
72409494|NCT00113516|144327333|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.0||||0.929|TWO_SIDED|95.0|0.51|1.86|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group.|Cycle 1, Day 28||1.86|0.51|0.9290
72538331|NCT03692078|144605818|EQUIVALENCE|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 5 is equal to Group 6 on Day 5. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 5 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|-1.9||||1|TWO_SIDED|95.0|-38.3|34.5|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 5 is equal to Group 6 on Day 5. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 5 is NOT equal to Group 6 on Day 5. (mITT Population)||34.5|-38.3|1.0000
72538332|NCT03692078|144605818|EQUIVALENCE|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 5 is equal to Group 6 on Day 7. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 5 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|-9.4||||0.9926|TWO_SIDED|95.0|-46.4|27.6|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 5 is equal to Group 6 on Day 7. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 5 is NOT equal to Group 6 on Day 7. (mITT Population)||27.6|-46.4|0.9926
72538333|NCT03692078|144605820|EQUIVALENCE|Null hypothesis: Whole Blood COHB (% Saturation) in Group 1 is equal to zero on Day 5. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 1 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|1.872|||<|0.0001|TWO_SIDED|95.0|1.81|1.935|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Whole Blood COHB (% Saturation) in Group 1 is equal to zero on Day 5. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 1 is NOT equal to zero on Day 5. (mITT Population)||1.935|1.810|<.0001
72574959|NCT00311402|144675983|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.04||||0.919||95.0|0.48|2.25|||Regression, Cox|||Non-event rate was calculated by using the Kaplan-Meier method and the comparison of groups was made by using the Cox proportional hazard regression model.||2.25|0.48|0.919
72574960|NCT00311402|144675984|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.34||||0.101||95.0|0.94|1.91|||Regression, Cox|||Non-event rate was calculated by using the Kaplan-Meier method and the comparison of groups was made by using the Cox proportional hazard regression model.||1.91|0.94|0.101
72574961|NCT02640053|144675985|SUPERIORITY|||||||0.26|||||||Wilcoxon (Mann-Whitney)|||||||0.26
72574962|NCT02640053|144675986|SUPERIORITY|||||||0.72|||||||Wilcoxon (Mann-Whitney)|||||||0.72
72574963|NCT02640053|144675987|SUPERIORITY|||||||0.39|||||||Wilcoxon (Mann-Whitney)|||||||0.39
72574964|NCT02640053|144675988|SUPERIORITY|||||||0.32|||||||Wilcoxon (Mann-Whitney)|||||||0.32
72574965|NCT02640053|144675989|SUPERIORITY|||||||0.41|||||||Wilcoxon (Mann-Whitney)|||||||0.41
72574966|NCT02640053|144675990|SUPERIORITY|||||||0.76|||||||Wilcoxon (Mann-Whitney)|||||||0.76
72574967|NCT02640053|144675991|SUPERIORITY|||||||0.62|||||||Wilcoxon (Mann-Whitney)|||||||0.62
72574968|NCT02640053|144675992|SUPERIORITY|||||||0.67|||||||Wilcoxon (Mann-Whitney)|||||||0.67
72574969|NCT02036775|144676000|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of relative bioavailability without molar mass adjustment (dose adjustment) was based upon two-sided 90% confidence intervals (CIs) for the ratios of the geometric means (test divided by reference) of the area under the curve (AUCss 0-24) using an acceptance range of 80%-125%.|Adjusted Geometric Mean Ratio (%)|110.68|STANDARD_DEVIATION|20.42|||TWO_SIDED|90.0|99.84|122.69|||||The standard deviation is actually the intra-individual geometric coefficient of variation (gCV(%))|||122.69|99.84|
72574970|NCT02036775|144676000|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of relative bioavailability without molar mass adjustment (dose adjustment) was based upon two-sided 90% confidence intervals (CIs) for the ratios of the geometric means (test divided by reference) of the area under the curve (AUCss 0-24) using an acceptance range of 80%-125%.|Adjusted Geometric Mean Ratio (%)|103.39|STANDARD_DEVIATION|13.52|||TWO_SIDED|90.0|96.54|110.74|||||The standard deviation is actually the intra-individual geometric coefficient of variation (gCV(%))|||110.74|96.54|
72409495|NCT00113516|144327333|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.9||||0.8195|TWO_SIDED|95.0|0.44|1.91|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group.|Cycle 2, Day 1||1.91|0.44|0.8195
72409496|NCT00113516|144327333|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.6||||0.221|TWO_SIDED|95.0|0.26|1.38|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group.|Cycle 2, Day 28||1.38|0.26|0.2210
72409497|NCT00113516|144327333|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.7||||0.4297|TWO_SIDED|95.0|0.24|1.85|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group.|Cycle 3, Day 1||1.85|0.24|0.4297
72574971|NCT02036775|144676000|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of relative bioavailability without molar mass adjustment (dose adjustment) was based upon two-sided 90% confidence intervals (CIs) for the ratios of the geometric means (test divided by reference) of the area under the curve (AUCss 0-24) using an acceptance range of 80%-125%.|Adjusted Geometric Mean Ratio (%)|106.93|STANDARD_DEVIATION|12.65|||TWO_SIDED|90.0|100.29|114.02|||||The standard deviation is actually the intra-individual geometric coefficient of variation (gCV(%))|||114.02|100.29|
72574972|NCT02036775|144676001|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of relative bioavailability without molar mass adjustment (dose adjustment) was based upon two-sided 90% confidence intervals (CIs) for the ratios of the geometric means (test divided by reference) of the peak concentration (Cmax ss) using an acceptance range of 75%-133%.|Adjusted Geometric Mean Ratio (%)|84.72|STANDARD_DEVIATION|19.01|||TWO_SIDED|90.0|76.96|93.25|||||The standard deviation is actually the intra-individual geometric coefficient of variation (gCV(%))|||93.25|76.96|
72574973|NCT02036775|144676001|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of relative bioavailability without molar mass adjustment (dose adjustment) was based upon two-sided 90% confidence intervals (CIs) for the ratios of the geometric means (test divided by reference) of the peak concentration (Cmax ss) using an acceptance range of 75%-133%.|Adjusted Geometric Mean Ratio (%)|103.87|STANDARD_DEVIATION|17.19|||TWO_SIDED|90.0|95.22|113.31|||||The standard deviation is actually the intra-individual geometric coefficient of variation (gCV(%))|||113.31|95.22|
72409498|NCT00113516|144327333|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.3||||0.0522|TWO_SIDED|95.0|0.06|1.11|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group.|Cycle 3, Day 28||1.11|0.06|0.0522
72409499|NCT00113516|144327333|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.6||||0.6949|TWO_SIDED|95.0|0.05|7.0|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group.|Cycle 5, Day 28||7.00|0.05|0.6949
72538334|NCT03692078|144605820|EQUIVALENCE|Null hypothesis: Whole Blood COHB (% Saturation) in Group 1 is equal to zero on Day 7. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 1 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|1.913|||<|0.0001|TWO_SIDED|95.0|1.851|1.976|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Whole Blood COHB (% Saturation) in Group 1 is equal to zero on Day 7. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 1 is NOT equal to zero on Day 7. (mITT Population)||1.976|1.851|<.0001
72538335|NCT03692078|144605820|EQUIVALENCE|Null hypothesis: Whole Blood COHB (% Saturation) in Group 2 is equal to zero on Day 5. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 2 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|1.467|||<|0.0001|TWO_SIDED|95.0|1.408|1.525|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Whole Blood COHB (% Saturation) in Group 2 is equal to zero on Day 5. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 2 is NOT equal to zero on Day 5. (mITT Population)||1.525|1.408|<.0001
72538336|NCT03692078|144605820|EQUIVALENCE|Null hypothesis: Whole Blood COHB (% Saturation) in Group 2 is equal to zero on Day 7. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 2 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|1.493|||<|0.0001|TWO_SIDED|95.0|1.434|1.551|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Whole Blood COHB (% Saturation) in Group 2 is equal to zero on Day 7. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 2 is NOT equal to zero on Day 7. (mITT Population)||1.551|1.434|<.0001
72574974|NCT02036775|144676001|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of relative bioavailability without molar mass adjustment (dose adjustment) was based upon two-sided 90% confidence intervals (CIs) for the ratios of the geometric means (test divided by reference) of the peak concentration (Cmax ss) using an acceptance range of 75%-133%.|Adjusted Geometric Mean Ratio (%)|80.94|STANDARD_DEVIATION|17.95|||TWO_SIDED|90.0|73.92|88.62|||||The standard deviation is actually the intra-individual geometric coefficient of variation (gCV(%))|||88.62|73.92|
72574975|NCT02036775|144676002|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of relative bioavailability without molar mass adjustment (dose adjustment) was based upon two-sided 90% confidence intervals (CIs) for the ratios of the geometric means (test divided by reference) for the dose-adjusted total exposure (AUCss 0-24 norm) using an acceptance range of 80%-125%.|Adjusted Geometric Mean Ratio (%)|88.54|STANDARD_DEVIATION|20.42|||TWO_SIDED|90.0|79.87|98.15|||||The standard deviation is actually the intra-individual geometric coefficient of variation (gCV(%))|||98.15|79.87|
72574976|NCT02036775|144676002|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of relative bioavailability without molar mass adjustment (dose adjustment) was based upon two-sided 90% confidence intervals (CIs) for the ratios of the geometric means (test divided by reference) for the dose-adjusted total exposure (AUCss 0-24 norm) using an acceptance range of 80%-125%.|Adjusted Geometric Mean Ratio (%)|103.39|STANDARD_DEVIATION|13.52|||TWO_SIDED|90.0|96.54|110.74|||||The standard deviation is actually the intra-individual geometric coefficient of variation (gCV(%))|||110.74|96.54|
72574977|NCT02036775|144676002|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of relative bioavailability without molar mass adjustment (dose adjustment) was based upon two-sided 90% confidence intervals (CIs) for the ratios of the geometric means (test divided by reference) for the dose-adjusted total exposure (AUCss 0-24 norm) using an acceptance range of 80%-125%.|Adjusted Geometric Mean Ratio (%)|85.55|STANDARD_DEVIATION|12.65|||TWO_SIDED|90.0|80.23|91.22|||||The standard deviation is actually the intra-individual geometric coefficient of variation (gCV(%))|||91.22|80.23|
72574978|NCT02036775|144676003|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of relative bioavailability without molar mass adjustment (dose adjustment) was based upon two-sided 90% confidence intervals (CIs) for the ratios of the geometric means (test divided by reference) for the rate of absorption at steady state (Cmax ss/AUCss 0-24) using an acceptance range of 75%-133%.|Adjusted Geometric Mean Ratio (%)|76.55|STANDARD_DEVIATION|14.55|||TWO_SIDED|90.0|71.1|82.4|||||The standard deviation is actually the intra-individual geometric coefficient of variation (gCV(%))|||82.40|71.10|
72409500|NCT00113516|144327334|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.9||||0.766|TWO_SIDED|95.0|0.51|1.65|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group.|Cycle 1, Day 1||1.65|0.51|0.7660
72409501|NCT00113516|144327334|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.5||||0.2682|TWO_SIDED|95.0|0.72|3.23|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group.|Cycle 1, Day 28||3.23|0.72|0.2682
72409502|NCT00113516|144327334|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.6||||0.2726|TWO_SIDED|95.0|0.69|3.7|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group.|Cycle 2, Day 1||3.70|0.69|0.2726
72409503|NCT00113516|144327334|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.6||||0.2787|TWO_SIDED|95.0|0.22|1.55|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group.|Cycle 2, Day 28||1.55|0.22|0.2787
72574979|NCT02036775|144676003|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of relative bioavailability without molar mass adjustment (dose adjustment) was based upon two-sided 90% confidence intervals (CIs) for the ratios of the geometric means (test divided by reference) for the rate of absorption at steady state (Cmax ss/AUCss 0-24) using an acceptance range of 75%-133%.|Adjusted Geometric Mean Ratio (%)|100.46|STANDARD_DEVIATION|11.65|||TWO_SIDED|90.0|94.69|106.58|||||The standard deviation is actually the intra-individual geometric coefficient of variation (gCV(%))|||106.58|94.69|
72574980|NCT02036775|144676003|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of relative bioavailability without molar mass adjustment (dose adjustment) was based upon two-sided 90% confidence intervals (CIs) for the ratios of the geometric means (test divided by reference) for the rate of absorption at steady state (Cmax ss/AUCss 0-24) using an acceptance range of 75%-133%.|Adjusted Geometric Mean Ratio (%)|75.69|STANDARD_DEVIATION|15.64|||TWO_SIDED|90.0|69.92|81.93|||||The standard deviation is actually the intra-individual geometric coefficient of variation (gCV(%))|||81.93|69.92|
72574981|NCT00678886|144676012|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.01||||0.813|TWO_SIDED|95.0|-0.06|0.08|||Mixed effects repeated measures model|||Mixed meal-stimulated C-peptide AUC, Placebo Vs Otelixizumab at Month 12||0.08|-0.06|0.813
72574982|NCT00678886|144676013|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.9||||0.737|TWO_SIDED|95.0|0.47|1.7|||Hochberg adjusted|||Percentage of responders, Placebo Vs Otelixizumab at Week 12||1.70|0.47|0.737
72574983|NCT00678886|144676013|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.77||||0.737|TWO_SIDED|95.0|0.42|1.39|||Hochberg adjusted|||Percentage of responders, Placebo Vs Otelixizumab at Month 6||1.39|0.42|0.737
72409504|NCT00113516|144327334|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|4.4||||0.0241|TWO_SIDED|95.0|1.09|17.56|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group.|Cycle 3, Day 1||17.56|1.09|0.0241
72574984|NCT00678886|144676013|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.81||||0.481|TWO_SIDED|95.0|0.45|1.46|||Hochberg adjusted|||Percentage of responders, Placebo Vs Otelixizumab at Month 12||1.46|0.45|0.481
72574985|NCT00678886|144676014|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.03||||0.281|TWO_SIDED|95.0|-0.07|0.01|||Mixed effects repeated measures model|Mixed effects repeated measures models was adjusted for age, continent, and baseline parameter value.||Mean insulin use, Placebo Vs Otelixizumab at Week 12||0.01|-0.07|0.281
72574986|NCT00678886|144676014|SUPERIORITY||Mean Difference (Net)|0.0||||0.969|TWO_SIDED|95.0|-0.05|0.05|||Mixed effects repeated measures model|Mixed effects repeated measures models was adjusted for age, continent, and baseline parameter value.||Mean insulin use, Placebo Vs Otelixizumab at Month 6||0.05|-0.05|0.969
72574987|NCT00678886|144676014|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.03||||0.272|TWO_SIDED|95.0|-0.08|0.02|||Mixed effects repeated measures model|Mixed effects repeated measures models was adjusted for age, continent, and baseline parameter value.||Mean insulin use, Placebo Vs Otelixizumab at Month 12||0.02|-0.08|0.272
72574988|NCT00678886|144676015|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.18||||0.289|TWO_SIDED|95.0|-0.16|0.52|||Mixed effects repeated measures model|Mixed effects repeated measures models was adjusted for age, continent, and baseline parameter value.||HbA1c levels, Placebo Vs Otelixizumab at Month 12||0.52|-0.16|0.289
72574989|NCT00678886|144676015|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.17||||0.538|TWO_SIDED|95.0|-0.15|0.49|||Mixed effects repeated measures model|Mixed effects repeated measures models was adjusted for age, continent, and baseline parameter value.||HbA1c levels, Placebo Vs Otelixizumab at Month 6||0.49|-0.15|0.538
72574990|NCT00678886|144676015|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.09||||0.538|TWO_SIDED|95.0|-0.19|0.36|||Mixed effects repeated measures model|Mixed effects repeated measures models was adjusted for age, continent, and baseline parameter value.||HbA1c levels, Placebo Vs Otelixizumab at Week 12||0.36|-0.19|0.538
72574991|NCT00678886|144676024|SUPERIORITY_OR_OTHER||Median Difference (Net)|1.12||||0.54|TWO_SIDED|95.0|-0.88|3.11|||Mixed effects repeated measures model|||ADRR, Placebo Vs Otelixizumab at Week 12||3.11|-0.88|0.540
72409505|NCT00113516|144327334|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|5.4||||0.0943|TWO_SIDED|95.0|0.59|48.81|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group.|Cycle 3, Day 28||48.81|0.59|0.0943
72409506|NCT00113516|144327334|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.7||||0.8084|TWO_SIDED|95.0|0.04|11.79|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group.|Cycle 5, Day 28||11.79|0.04|0.8084
72574992|NCT00678886|144676024|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.83||||0.546|TWO_SIDED|95.0|-1.89|3.56|||Mixed effects repeated measures model|||ADRR, Placebo Vs Otelixizumab at Month 6||3.56|-1.89|0.546
72574993|NCT00678886|144676024|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.93||||0.462|TWO_SIDED|95.0|-1.56|3.42|||Mixed effects repeated measures model|||ADRR, Placebo Vs Otelixizumab at Month 12||3.42|-1.56|0.462
72574994|NCT00678886|144676025|SUPERIORITY_OR_OTHER|||||||0.957|||||||Hochberg-adjusted|||Composite Rank Summary for HbA1c and Exogenous Insulin Use, Placebo Vs Otelixizumab at Month 6||||0.957
72574995|NCT00678886|144676025|SUPERIORITY_OR_OTHER|||||||0.957|||||||Hochberg-adjusted|||Composite Rank Summary for HbA1c and Exogenous Insulin Use, Placebo Vs Otelixizumab at Month 12||||0.957
72574996|NCT00678886|144676026|SUPERIORITY_OR_OTHER|||||||0.653|||||||Hochberg-adjusted|||Composite Rank Summary for C-Peptide AUC, HbA1c and Exogenous Insulin Use, Placebo Vs Otelixizumab at Month 6||||0.653
72574997|NCT00678886|144676026|SUPERIORITY_OR_OTHER|||||||0.653|||||||Hochberg-adjusted|||Composite Rank Summary for C-Peptide AUC, HbA1c and Exogenous Insulin Use, Placebo Vs Otelixizumab at Month 12||||0.653
72574998|NCT00206323|144676032|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0259|||||||t-test, 2 sided|||"Primary variable change of TTS/YGTSS at the BSL to Day 70. Changes of YGTSS compared using analysis of covariance with score at day 1 as a covariate. Groups compared for incidence of AE's and of AESI based on Fisher's Exact Test. All tests were two-sided at the 5% level of significance.~The Total Tic Score is a summation of the Total Motor Tic and Total Phonic Tic Scores. The Overall Impairment Rating is rated on a 50-point scale anchored by 0 (No impairment) and 50 (Severe impairment)"||||0.0259
72574999|NCT01943994|144676033|SUPERIORITY||Odds Ratio (OR)|6.12||||0.003|TWO_SIDED|95.0|1.99|23.26|||Regression, Logistic|||||23.26|1.99|0.003
72575000|NCT02304458|144676076|OTHER|Maximum Tolerate Dose Level was determined by the rolling-6 design.|Maximum Tolerate Dose Level|3.0|||||TWO_SIDED||||||||Maximum Tolerate Dose Level is 3 mg/kg Nivolumab|||||
72409507|NCT03235024|144327341|EQUIVALENCE|A sample size of 52 per group would achieve \>80% power to reject the null hypothesis of equal means when the population mean difference is μ1 - μ2 = (-1.4) - (-5.3) = 3.9 with a standard deviation for both groups of 7.0 and with a significance level (alpha) of 0.025 using a 1-sided 2-sample equal variance t-test.||||||0.0228||||||At Week 2|t-test, 1 sided|||||||0.0228
72538337|NCT03692078|144605820|EQUIVALENCE|Null hypothesis: Whole Blood COHB (% Saturation) in Group 3 is equal to zero on Day 5. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 3 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|1.55|||<|0.0001|TWO_SIDED|95.0|1.49|1.609|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Whole Blood COHB (% Saturation) in Group 3 is equal to zero on Day 5. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 3 is NOT equal to zero on Day 5. (mITT Population)||1.609|1.490|<.0001
72538338|NCT03692078|144605820|EQUIVALENCE|Null hypothesis: Whole Blood COHB (% Saturation) in Group 3 is equal to zero on Day 7. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 3 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|1.594|||<|0.0001|TWO_SIDED|95.0|1.533|1.654|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Whole Blood COHB (% Saturation) in Group 3 is equal to zero on Day 7. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 3 is NOT equal to zero on Day 7. (mITT Population)||1.654|1.533|<.0001
72538339|NCT03692078|144605820|EQUIVALENCE|Null hypothesis: Whole Blood COHB (% Saturation) in Group 4 is equal to zero on Day 5. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 4 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|0.557|||<|0.0001|TWO_SIDED|95.0|0.482|0.631|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Whole Blood COHB (% Saturation) in Group 4 is equal to zero on Day 5. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 4 is NOT equal to zero on Day 5. (mITT Population)||0.631|0.482|<.0001
72538340|NCT03692078|144605820|EQUIVALENCE|Null hypothesis: Whole Blood COHB (% Saturation) in Group 4 is equal to zero on Day 7. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 4 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|0.589|||<|0.0001|TWO_SIDED|95.0|0.514|0.665|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Whole Blood COHB (% Saturation) in Group 4 is equal to zero on Day 7. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 4 is NOT equal to zero on Day 7. (mITT Population)||0.665|0.514|<.0001
72538341|NCT03692078|144605820|EQUIVALENCE|Null hypothesis: Whole Blood COHB (% Saturation) in Group 5 is equal to zero on Day 5. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 5 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|0.533|||<|0.0001|TWO_SIDED|95.0|0.461|0.605|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Whole Blood COHB (% Saturation) in Group 5 is equal to zero on Day 5. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 5 is NOT equal to zero on Day 5. (mITT Population)||0.605|0.461|<.0001
72538342|NCT03692078|144605820|EQUIVALENCE|Null hypothesis: Whole Blood COHB (% Saturation) in Group 5 is equal to zero on Day 7. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 5 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|0.588|||<|0.0001|TWO_SIDED|95.0|0.514|0.662|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Whole Blood COHB (% Saturation) in Group 5 is equal to zero on Day 7. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 5 is NOT equal to zero on Day 7. (mITT Population)||0.662|0.514|<.0001
72538343|NCT03692078|144605820|EQUIVALENCE|Null hypothesis: Whole Blood COHB (% Saturation) in Group 6 is equal to zero on Day 5. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 6 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|0.58|||<|0.0001|TWO_SIDED|95.0|0.508|0.652|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Whole Blood COHB (% Saturation) in Group 6 is equal to zero on Day 5. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 6 is NOT equal to zero on Day 5. (mITT Population)||0.652|0.508|<.0001
72575001|NCT02288182|144676090|SUPERIORITY|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||Student's t-test comparing the group means was planned and performed (successfully). However, due to some outliers, the central tendencies have been reported as medians (instead of arithmetic means). Therefore an additional non-parameteric test (Mann-Whitney U-test) was performed.||||0.001
72575002|NCT00461253|144676094|NON_INFERIORITY_OR_EQUIVALENCE|Assuming a prevalence of current Mirena use among fertile women of 8% in Finland and 2% in Germany, it was estimated that 3,500 cases and 14,000 controls would be needed to exclude a 1.5-fold breast cancer risk for Mirena users compared with users of copper IUDs.|Odds Ratio (OR)|0.99|||||TWO_SIDED|95.0|0.88|1.12|||||Breast cancer OR for ever use of LNG-IUD vs. Cu-IUD; adjusted for BMI, family history of breast cancer, age at first birth, age at menarche and physical activity (primary analysis)|In this matched case-control study, conditional logistic regression was used to investigate the relationship between a woman being a breast cancer case or a control (dichotomous dependent variable), and a set of actual or potential prognostic factors (covariates) for breast cancer (incl. the use of Mirena). Conditional logistic regression uses a maximum likelihood approach for estimating the covariates; data are stratified and the likelihoods are computed relative to each stratum.||1.12|0.88|
72409508|NCT00835406|144327379|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA will be performed on ln-transformed Ae0-36 and Rmax at the α level of 0.05.|Ratio of the mean|97.94||||||90.0|90.96|105.45|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||105.45|90.96|
72538344|NCT03692078|144605820|EQUIVALENCE|Null hypothesis: Whole Blood COHB (% Saturation) in Group 6 is equal to zero on Day 7. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 6 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|0.58|||<|0.0001|TWO_SIDED|95.0|0.507|0.653|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Whole Blood COHB (% Saturation) in Group 6 is equal to zero on Day 7. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 6 is NOT equal to zero on Day 7. (mITT Population)||0.653|0.507|<.0001
72538345|NCT03692078|144605820|EQUIVALENCE|Null hypothesis: Whole Blood COHB (% Saturation) in Group 2 is equal to Group 1 on Day 5. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 2 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-0.406|||<|0.0001|TWO_SIDED|95.0|-0.526|-0.285|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Whole Blood COHB (% Saturation) in Group 2 is equal to Group 1 on Day 5. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 2 is NOT equal to Group 1 on Day 5. (mITT Population)||-0.285|-0.526|<.0001
72538346|NCT03692078|144605820|EQUIVALENCE|Null hypothesis: Whole Blood COHB (% Saturation) in Group 2 is equal to Group 1 on Day 7. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 2 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-0.421|||<|0.0001|TWO_SIDED|95.0|-0.541|-0.3|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Whole Blood COHB (% Saturation) in Group 2 is equal to Group 1 on Day 7. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 2 is NOT equal to Group 1 on Day 7. (mITT Population)||-0.300|-0.541|<.0001
72538347|NCT03692078|144605820|EQUIVALENCE|Null hypothesis: Whole Blood COHB (% Saturation) in Group 3 is equal to Group 1 on Day 5. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 3 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-0.323|||<|0.0001|TWO_SIDED|95.0|-0.444|-0.201|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Whole Blood COHB (% Saturation) in Group 3 is equal to Group 1 on Day 5. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 3 is NOT equal to Group 1 on Day 5. (mITT Population)||-0.201|-0.444|<.0001
72538348|NCT03692078|144605820|EQUIVALENCE|Null hypothesis: Whole Blood COHB (% Saturation) in Group 3 is equal to Group 1 on Day 7. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 3 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-0.32|||<|0.0001|TWO_SIDED|95.0|-0.442|-0.198|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Whole Blood COHB (% Saturation) in Group 3 is equal to Group 1 on Day 7. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 3 is NOT equal to Group 1 on Day 7. (mITT Population)||-0.198|-0.442|<.0001
72538349|NCT03692078|144605820|EQUIVALENCE|Null hypothesis: Whole Blood COHB (% Saturation) in Group 4 is equal to Group 1 on Day 5. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 4 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-1.315|||<|0.0001|TWO_SIDED|95.0|-1.453|-1.178|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Whole Blood COHB (% Saturation) in Group 4 is equal to Group 1 on Day 5. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 4 is NOT equal to Group 1 on Day 5. (mITT Population)||-1.178|-1.453|<.0001
72538350|NCT03692078|144605820|EQUIVALENCE|Null hypothesis: Whole Blood COHB (% Saturation) in Group 4 is equal to Group 1 on Day 7. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 4 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-1.324|||<|0.0001|TWO_SIDED|95.0|-1.463|-1.186|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Whole Blood COHB (% Saturation) in Group 4 is equal to Group 1 on Day 7. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 4 is NOT equal to Group 1 on Day 7. (mITT Population)||-1.186|-1.463|<.0001
72538351|NCT03692078|144605820|EQUIVALENCE|Null hypothesis: Whole Blood COHB (% Saturation) in Group 5 is equal to Group 1 on Day 5. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 5 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-1.339|||<|0.0001|TWO_SIDED|95.0|-1.473|-1.205|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Whole Blood COHB (% Saturation) in Group 5 is equal to Group 1 on Day 5. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 5 is NOT equal to Group 1 on Day 5. (mITT Population)||-1.205|-1.473|<.0001
72575003|NCT00461253|144676094|NON_INFERIORITY_OR_EQUIVALENCE|Assuming a prevalence of current Mirena use among fertile women of 8% in Finland and 2% in Germany, it was estimated that 3,500 cases and 14,000 controls would be needed to exclude a 1.5-fold breast cancer risk for Mirena users compared with users of copper IUDs.|Odds Ratio (OR)|1.04|||||TWO_SIDED|95.0|0.93|1.17|||||Breast cancer OR for ever use of LNG-IUD vs. Cu-IUD, crude|In this matched case-control study, conditional logistic regression was used to investigate the relationship between a woman being a breast cancer case or a control (dichotomous dependent variable), and a set of actual or potential prognostic factors (covariates) for breast cancer (incl. the use of Mirena). Conditional logistic regression uses a maximum likelihood approach for estimating the covariates; data are stratified and the likelihoods are computed relative to each stratum.||1.17|0.93|
72409509|NCT00835406|144327380|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA will be performed on ln-transformed Ae0-35 and Rmax at the α level of 0.05.|Ratio of the mean|100.36||||||90.0|92.85|108.48|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||108.48|92.85|
72538352|NCT03692078|144605820|EQUIVALENCE|Null hypothesis: Whole Blood COHB (% Saturation) in Group 5 is equal to Group 1 on Day 7. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 5 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-1.325|||<|0.0001|TWO_SIDED|95.0|-1.461|-1.19|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Whole Blood COHB (% Saturation) in Group 5 is equal to Group 1 on Day 7. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 5 is NOT equal to Group 1 on Day 7. (mITT Population)||-1.190|-1.461|<.0001
72538353|NCT03692078|144605820|EQUIVALENCE|Null hypothesis: Whole Blood COHB (% Saturation) in Group 2 is equal to Group 6 on Day 5. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 2 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|0.887|||<|0.0001|TWO_SIDED|95.0|0.757|1.016|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Whole Blood COHB (% Saturation) in Group 2 is equal to Group 6 on Day 5. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 2 is NOT equal to Group 6 on Day 5. (mITT Population)||1.016|0.757|<.0001
72538354|NCT03692078|144605820|EQUIVALENCE|Null hypothesis: Whole Blood COHB (% Saturation) in Group 2 is equal to Group 6 on Day 7. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 2 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|0.912|||<|0.0001|TWO_SIDED|95.0|0.782|1.043|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Whole Blood COHB (% Saturation) in Group 2 is equal to Group 6 on Day 7. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 2 is NOT equal to Group 6 on Day 7. (mITT Population)||1.043|0.782|<.0001
72538355|NCT03692078|144605820|EQUIVALENCE|Null hypothesis: Whole Blood COHB (% Saturation) in Group 3 is equal to Group 6 on Day 5. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 3 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|0.97|||<|0.0001|TWO_SIDED|95.0|0.839|1.1|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Whole Blood COHB (% Saturation) in Group 3 is equal to Group 6 on Day 5. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 3 is NOT equal to Group 6 on Day 5. (mITT Population)||1.100|0.839|<.0001
72538356|NCT03692078|144605820|EQUIVALENCE|Null hypothesis: Whole Blood COHB (% Saturation) in Group 3 is equal to Group 6 on Day 7. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 3 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|1.013|||<|0.0001|TWO_SIDED|95.0|0.882|1.145|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Whole Blood COHB (% Saturation) in Group 3 is equal to Group 6 on Day 7. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 3 is NOT equal to Group 6 on Day 7. (mITT Population)||1.145|0.882|<.0001
72538357|NCT03692078|144605820|EQUIVALENCE|Null hypothesis: Whole Blood COHB (% Saturation) in Group 4 is equal to Group 6 on Day 5. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 4 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|-0.023||||0.9999|TWO_SIDED|95.0|-0.168|0.122|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Whole Blood COHB (% Saturation) in Group 4 is equal to Group 6 on Day 5. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 4 is NOT equal to Group 6 on Day 5. (mITT Population)||0.122|-0.168|0.9999
72575004|NCT00461253|144676094|NON_INFERIORITY_OR_EQUIVALENCE|Assuming a prevalence of current Mirena use among fertile women of 8% in Finland and 2% in Germany, it was estimated that 3,500 cases and 14,000 controls would be needed to exclude a 1.5-fold breast cancer risk for Mirena users compared with users of copper IUDs.|Odds Ratio (OR)|0.85|||||TWO_SIDED|95.0|0.52|1.39|||||"Breast cancer OR for current use of LNG-IUD vs. Cu-IUD at time of breast cancer diagnosis; adjusted for BMI, family history of breast cancer, age at first birth, age at first menarche, physical activity (primary analysis)"|In this matched case-control study, conditional logistic regression was used to investigate the relationship between a woman being a breast cancer case or a control (dichotomous dependent variable), and a set of actual or potential prognostic factors (covariates) for breast cancer (incl. the use of Mirena). Conditional logistic regression uses a maximum likelihood approach for estimating the covariates; data are stratified and the likelihoods are computed relative to each stratum.||1.39|0.52|
72409510|NCT02486406|144327393|SUPERIORITY||Wilson's score method|98.4|||||TWO_SIDED|95.0|91.7|99.7||||||According to the Highlights of Prescribing Information of PEGASYS, the SVR24 rate was 47% among 45 treatment-naïve pediatric participants with HCV GT1 in the NV17424 trial. To show that the DAA regimen is superior to this current standard of care by 20%, the lower bound of the 2-sided 95% confidence interval of the SVR12 rate across all participants in the study must be greater than 67%.||99.7|91.7|
72538358|NCT03692078|144605820|EQUIVALENCE|Null hypothesis: Whole Blood COHB (% Saturation) in Group 4 is equal to Group 6 on Day 7. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 4 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|0.009||||1|TWO_SIDED|95.0|-0.138|0.155|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Whole Blood COHB (% Saturation) in Group 4 is equal to Group 6 on Day 7. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 4 is NOT equal to Group 6 on Day 7. (mITT Population)||0.155|-0.138|1.0000
72538359|NCT03692078|144605820|EQUIVALENCE|Null hypothesis: Whole Blood COHB (% Saturation) in Group 5 is equal to Group 6 on Day 5. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 5 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|-0.047||||0.9577|TWO_SIDED|95.0|-0.189|0.095|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Whole Blood COHB (% Saturation) in Group 5 is equal to Group 6 on Day 5. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 5 is NOT equal to Group 6 on Day 5. (mITT Population)||0.095|-0.189|0.9577
72538360|NCT03692078|144605820|EQUIVALENCE|Null hypothesis: Whole Blood COHB (% Saturation) in Group 5 is equal to Group 6 on Day 7. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 5 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|0.008||||1|TWO_SIDED|95.0|-0.136|0.152|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Whole Blood COHB (% Saturation) in Group 5 is equal to Group 6 on Day 7. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 5 is NOT equal to Group 6 on Day 7. (mITT Population)||0.152|-0.136|1.0000
72538361|NCT01005680|144605828|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.03||||0.822|TWO_SIDED|95.0|0.77|1.39||HR adjusted for treatment, disease stage, Eastern Cooperative Oncology Group Performance Status (ECOG PS), sex, and basis for initial pathological diagnosis.|Cox Proportional Hazard|||||1.39|0.77|0.822
72538362|NCT01005680|144605829|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.06||||0.64|TWO_SIDED|95.0|0.82|1.37||HR adjusted for treatment, disease stage, Eastern Cooperative Oncology Group Performance Status (ECOG PS), sex and basis for initial pathological diagnosis.|Cox Proportional Hazard|||||1.37|0.82|0.640
72575005|NCT00461253|144676094|NON_INFERIORITY_OR_EQUIVALENCE|Assuming a prevalence of current Mirena use among fertile women of 8% in Finland and 2% in Germany, it was estimated that 3,500 cases and 14,000 controls would be needed to exclude a 1.5-fold breast cancer risk for Mirena users compared with users of copper IUDs.|Odds Ratio (OR)|0.9|||||TWO_SIDED|95.0|0.58|1.41|||||"Breast cancer OR for current use of LNG-IUD vs. Cu-IUD at time of breast cancer diagnosis, crude"|In this matched case-control study, conditional logistic regression was used to investigate the relationship between a woman being a breast cancer case or a control (dichotomous dependent variable), and a set of actual or potential prognostic factors (covariates) for breast cancer (incl. the use of Mirena). Conditional logistic regression uses a maximum likelihood approach for estimating the covariates; data are stratified and the likelihoods are computed relative to each stratum.||1.41|0.58|
72575006|NCT04240392|144676095|SUPERIORITY||Odds Ratio (OR)|1.369||||0.534|TWO_SIDED|95.0|0.462|4.055|||Mixed Models Analysis|Generalized Linear Mixed Model||||4.055|0.462|0.5340
72575007|NCT04240392|144676096|SUPERIORITY||Odds Ratio (OR)|0.803||||0.6|TWO_SIDED|95.0|0.326|1.979|||Mixed Models Analysis|Generalized Linear Mixed Model||At delivery||1.979|0.326|0.600
72575008|NCT04240392|144676096|SUPERIORITY||Odds Ratio (OR)|0.709||||0.471|TWO_SIDED|95.0|0.254|1.975|||Mixed Models Analysis|Generalized Linear Mixed Model||At 3 months post partum||1.975|0.254|0.471
72575009|NCT04240392|144676097|SUPERIORITY||Beta-coefficient|1.53||||0.518|TWO_SIDED|95.0|-3.13|6.19|||Mixed Models Analysis|Repeated Measures Linear Mixed Model|Beta-coefficient for treatment for time interaction term|At week 36||6.19|-3.13|0.518
72575010|NCT04240392|144676097|SUPERIORITY||Beta-coefficient|0.32||||0.893|TWO_SIDED|95.0|-4.41|5.06|||Mixed Models Analysis|Repeated Measures Linear Mixed Model|Beta-coefficient for treatment for time interaction term|At 3 months post partum||5.06|-4.41|0.893
72575011|NCT03047330|144676121|SUPERIORITY|||||||0.22|||||||Mixed Models Analysis|||||||0.22
72575012|NCT03047330|144676121|SUPERIORITY|||||||0.001|||||||Mixed Models Analysis|||||||0.001
72575013|NCT03047330|144676122|SUPERIORITY|||||||0.048|||||||Mixed Models Analysis|||||||0.048
72575014|NCT03047330|144676122|SUPERIORITY|||||||0.58|||||||Mixed Models Analysis|||||||0.58
72575015|NCT04684238|144676151|OTHER|Least square means of the difference between the treatment groups, including a 2-sided 95% confidence interval was reported in the statistical analysis. The noninferiority criterion was a relative difference of less than 15% between treatment groups.|Least square means|6.57|||||TWO_SIDED|95.0|-8.99|22.13||Noninferiority was defined as the entire 95% CI for the difference being above the noninferiority margin for the relative difference of -15%. Testing the hypothesis of no difference between isoflurane and midazolam.|Mixed Models Analysis|||||22.13|-8.99|
72538363|NCT01005680|144605830|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.01||||0.928|TWO_SIDED|95.0|0.78|1.32||HR adjusted for treatment, disease stage, Eastern Cooperative Oncology Group Performance Status (ECOG PS), sex and biases for initial pathological diagnosis.|Cox Proportional Hazard|||||1.32|0.78|0.928
72538364|NCT01005680|144605831|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.96||||0.887|TWO_SIDED|95.0|0.51|1.79||HR adjusted for treatment, disease stage, Eastern Cooperative Oncology Group Performance Status (ECOG PS), sex and basis for initial pathological diagnosis.|Cox Proportional Hazard|||||1.79|0.51|0.887
72538365|NCT01005680|144605832|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.04||||0.861|TWO_SIDED|95.0|0.67|1.61||HR adjusted for treatment, disease stage, Eastern Cooperative Oncology Group Performance Status (ECOG PS), sex and basis for initial pathological diagnosis.|Cox Proportional Hazard|||||1.61|0.67|0.861
72538366|NCT01005680|144605833|SUPERIORITY_OR_OTHER|||||||0.451||95.0|||||two-sided Z test|||||||0.451
72538367|NCT01005680|144605835|SUPERIORITY_OR_OTHER|||||||0.627||95.0|||||two-sided Z test|||||||0.627
72538368|NCT01339858|144605857|SUPERIORITY|||||||0.32|||||||ANOVA|||||||0.32
72538369|NCT00996632|144605866|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Wilcoxon (Mann-Whitney)|||null hypothesis is that drainage volumes are not different||||<0.05
72538370|NCT00996632|144605867|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||Wilcoxon (Mann-Whitney)|||null hypothesis is that Stay in Hospital Days are not different||||0.05
72538371|NCT01598740|144605871|SUPERIORITY_OR_OTHER|||||||0.0662||95.0|||||ANCOVA|||One-way analysis of covariance (ANCOVA) common slopes model for a 2-period crossover design.||||0.0662
72538372|NCT01598740|144605872|SUPERIORITY_OR_OTHER|||||||0.1899||95.0|||||ANCOVA|||One-way analysis of covariance (ANCOVA) common slopes model for a 2-period crossover design.||||0.1899
72538373|NCT04342130|144605876|OTHER||||||>|0.05|||||||t-test, 2 sided|||||||>0.05
72538374|NCT00090259|144605922|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.899||||0.027|TWO_SIDED|95.0|0.818|0.988|||Regression, Cox|Model terms: treatment, region and β-blocker use at randomization|Direction of the Comparison: Hazard Ratio of experiencing the endpoint on Losartan 150 mg compared to Losartan 50 mg|||0.988|0.818|0.027
72538375|NCT00090259|144605923|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.924||||0.068|TWO_SIDED|95.0|0.848|1.006|||Regression, Cox|Model terms: treatment, region and β-blocker use at randomization|Direction of the Comparison: Hazard Ratio of experiencing the endpoint on Losartan 150 mg compared to Losartan 50 mg|||1.006|0.848|0.068
72538376|NCT00090259|144605924|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.936||||0.235|TWO_SIDED|95.0|0.84|1.044|||Regression, Cox|Model terms: treatment, region and β-blocker use at randomization|Direction of the Comparison: Hazard Ratio of experiencing the endpoint on Losartan 150 mg compared to Losartan 50 mg|||1.044|0.840|0.235
72538377|NCT00090259|144605925|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.865||||0.025|TWO_SIDED|95.0|0.762|0.982|||Regression, Cox|Model terms: treatment, region and β-blocker use at randomization|Direction of the Comparison: Hazard Ratio of experiencing the endpoint on Losartan 150 mg compared to Losartan 50 mg|||0.982|0.762|0.025
72538378|NCT00090259|144605926|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.892||||0.023|TWO_SIDED|95.0|0.808|0.984|||Regression, Cox|Model terms: treatment, region and β-blocker use at randomization|Direction of the Comparison: Hazard Ratio of experiencing the endpoint on Losartan 150 mg compared to Losartan 50 mg|||0.984|0.808|0.023
72538379|NCT00285012|144605949|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|8.4|||<|0.0001||95.0|4.99|14.14||p-value obtained from a logistic regression model including the main effects of treatment and pooled center|Regression, Logistic||odds ratio obtained from a logistic regression model including the main effects of treatment and pooled center|Primary endpoint was based on a CO confirmed 4-week CQR (weeks 4 through 12 inclusive). Intent was to evaluate the alternative hypothesis that varenicline is superior to placebo for smoking cessation after 12 weeks of treatment in subjects with mild to moderate COPD.||14.14|4.99|<0.0001
72575016|NCT04684238|144676152|NON_INFERIORITY|The non-inferiority margin was set to a relative difference of -15%.|Least square means|5.34|||||TWO_SIDED|95.0|-10.48|21.17||Testing the hypothesis of no difference between isoflurane and midazolam.||||||21.17|-10.48|
72575017|NCT04684238|144676153|SUPERIORITY||Mean Difference (Final Values)|-2.5||||0.0004|TWO_SIDED|95.0|-3.8|-1.1|||ANCOVA|||||-1.1|-3.8|0.0004
72575018|NCT04684238|144676154|SUPERIORITY|Results display comparison between isoflurane and midazolam and are based on an analysis of variance model with treatment group as fixed effect and baseline opioid dose as covariate.|Mean Difference (Final Values)|-0.77||||0.096|TWO_SIDED|95.0|-1.69|0.14|||ANCOVA|||||0.14|-1.69|0.096
72575019|NCT04684238|144676155|SUPERIORITY||Hazard Ratio (HR)|3.3||||0.0021|TWO_SIDED|95.0|1.54|7.07|||Regression, Cox|||Time to extubation||7.07|1.54|0.0021
72575020|NCT04684238|144676156|SUPERIORITY||Mean Difference (Final Values)|0.05||||0.636|TWO_SIDED|95.0|-0.15|0.25|||ANOVA|||Spontaneous breathing efforts. Results display a comparison between isoflurane and midazolam and are based on a mixed effects analysis of variance model with treatment group as fixed effect.||0.25|-0.15|0.636
72575021|NCT04684238|144676157|SUPERIORITY|Results display comparison between isoflurane and midazolam and are based on a Wilcoxon ranksum test.||||||0.55|||||||Wilcoxon (Mann-Whitney)|||Need for inotropic/vasopressor agent at ≤24 hours.||||0.55
72538380|NCT00285012|144605950|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.88|||<|0.0001||95.0|2.75|8.65||p-value obtained from a logistic regression model including the main effects of treatment and pooled center|Regression, Logistic||odds ratio obtained from a logistic regression model including the main effects of treatment and pooled center|Varenicline versus (vs) placebo at Week 24||8.65|2.75|<0.0001
72538381|NCT00285012|144605950|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.04|||<|0.0001||95.0|2.13|7.67||p-value obtained from a logistic regression model including the main effects of treatment and pooled center|Regression, Logistic||odds ratio obtained from a logistic regression model including the main effects of treatment and pooled center|Varenicline vs placebo at Week 52||7.67|2.13|<0.0001
72538382|NCT00285012|144605951|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.17|||<|0.0001||95.0|2.96|9.02||p-value obtained from a logistic regression model including the main effects of treatment and pooled center|Regression, Logistic||odds ratio obtained from a logistic regression model including the main effects of treatment and pooled center|Varenicline vs placebo at Week 24||9.02|2.96|<0.0001
72538383|NCT00285012|144605951|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.92|||<|0.0001||95.0|2.18|7.07||p-value obtained from a logistic regression model including the main effects of treatment and pooled center|Regression, Logistic||odds ratio obtained from a logistic regression model including the main effects of treatment and pooled center|Varenicline vs placebo at Week 52||7.07|2.18|<0.0001
72538384|NCT00285012|144605952|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.99|||<|0.0001||95.0|4.39|11.11||p-value obtained from a logistic regression model including the main effects of treatment and pooled center|Regression, Logistic||odds ratio obtained from a logistic regression model including the main effects of treatment and pooled center|Varenicline vs placebo at Week 12||11.11|4.39|<0.0001
72538385|NCT00285012|144605952|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.85|||<|0.0001||95.0|1.79|4.54|||Regression, Logistic|p-value obtained from a logistic regression model including the main effects of treatment and pooled center|odds ratio obtained from a logistic regression model including the main effects of treatment and pooled center|Varenicline vs placebo at Week 24||4.54|1.79|<0.0001
72538386|NCT00285012|144605952|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.19||||0.0008||95.0|1.37|3.48||p-value obtained from a logistic regression model including the main effects of treatment and pooled center|Regression, Logistic||odds ratio obtained from a logistic regression model including the main effects of treatment and pooled center|Varenicline vs placebo at Week 52||3.48|1.37|0.0008
72538387|NCT00285012|144605953|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.45||||0.0002||95.0|1.52|3.95||p-value obtained from a logistic regression model including the main effects of treatment and pooled center|Regression, Logistic||odds ratio obtained from a logistic regression model including the main effects of treatment and pooled center|Varenicline vs placebo at Week 52||3.95|1.52|0.0002
72538388|NCT00285012|144605954|SUPERIORITY_OR_OTHER|||||||0.14||95.0|||||ANCOVA|p-value based on ANCOVA model with treatment and center as factors and baseline value as covariate.||Varenicline vs placebo at Week 12 \[LOCF\] pre-bronchodilator||||0.140
72538389|NCT00285012|144605954|SUPERIORITY_OR_OTHER|||||||0.007||95.0|||||ANCOVA|p-value based on ANCOVA model with treatment and center as factors and baseline value as covariate.||Varenicline vs placebo at Week 12 \[LOCF\] post-bronchodilator||||0.007
72409511|NCT02127307|144327400|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.446|||<|0.0001|TWO_SIDED|95.0|0.3227|0.6156||At 0.025 level of significance.|Cox proportional hazards model|||"AdreView-Heart Failure Group with H/M \<1.60 vs. H/M ≥1.60:~Data analysis was performed using Cox proportional hazards model to demonstrate the relationship of consensus numeric H/M ratio and time to adverse cardiac events to identify participants with higher risk of death. Hazard (risk) of a death for a participant with H/M ratio at time t was expressed as Hl (t)/Hh (t)=Ψ,where Hl (t) and Hh (t) denote the hazard of an event at time t for participants with low H/M and high H/M respectively."||0.6156|0.3227|<0.0001
72409512|NCT03509948|144327401|SUPERIORITY||Geometric Least Squares Mean|79.57|||||TWO_SIDED|90.0|66.4|95.35||||||Fed/Fasted Ratio||95.35|66.40|
72538390|NCT00285012|144605954|SUPERIORITY_OR_OTHER|||||||0.684||95.0|||||ANCOVA|p-value based on ANCOVA model with treatment and center as factors and baseline value as covariate.||Varenicline vs placebo at Week 52 \[LOCF\] pre-bronchodilator||||0.684
72538391|NCT00285012|144605954|SUPERIORITY_OR_OTHER|||||||0.901||95.0|||||ANCOVA|p-value based on ANCOVA model with treatment and center as factors and baseline value as covariate.||Varenicline vs placebo at Week 52 \[LOCF\] post-bronchodilator||||0.901
72538392|NCT00285012|144605955|SUPERIORITY_OR_OTHER|||||||0.078||95.0|||||ANCOVA|p-value obtained from ANCOVA model with fixed effect terms for center and treatment, and baseline score as a covariate.||Week 12 Mental State||||0.078
72538393|NCT00285012|144605955|SUPERIORITY_OR_OTHER|||||||0.109||95.0|||||ANCOVA|p-value obtained from ANCOVA model with fixed effect terms for center and treatment, and baseline score as a covariate.||Week 24 Mental State||||0.109
72538394|NCT00285012|144605955|SUPERIORITY_OR_OTHER|||||||0.281||95.0|||||ANCOVA|p-value obtained from ANCOVA model with fixed effect terms for center and treatment, and baseline score as a covariate.||Week 52 Mental State||||0.281
72538395|NCT00285012|144605955|SUPERIORITY_OR_OTHER|||||||0.581||95.0|||||ANCOVA|p-value obtained from ANCOVA model with fixed effect terms for center and treatment, and baseline score as a covariate.||Week 12 Functional State||||0.581
72538396|NCT00285012|144605955|SUPERIORITY_OR_OTHER|||||||0.29||95.0|||||ANCOVA|p-value obtained from ANCOVA model with fixed effect terms for center and treatment, and baseline score as a covariate.||Week 24 Functional State||||0.290
72538397|NCT00285012|144605955|SUPERIORITY_OR_OTHER|||||||0.063||95.0|||||ANCOVA|p-value obtained from ANCOVA model with fixed effect terms for center and treatment, and baseline score as a covariate.||Week 52 Functional State||||0.063
72538398|NCT00285012|144605955|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||ANCOVA|p-value obtained from ANCOVA model with fixed effect terms for center and treatment, and baseline score as a covariate.||Week 12 Respiratory Symptoms||||0.002
72538399|NCT00285012|144605955|SUPERIORITY_OR_OTHER|||||||0.081||95.0|||||ANCOVA|p-value obtained from ANCOVA model with fixed effect terms for center and treatment, and baseline score as a covariate.||Week 24 Respiratory Symptoms||||0.081
72538400|NCT00285012|144605955|SUPERIORITY_OR_OTHER|||||||0.016||95.0|||||ANCOVA|p-value obtained from ANCOVA model with fixed effect terms for center and treatment, and baseline score as a covariate.||Week 52 Respiratory Symptoms||||0.016
72538401|NCT00285012|144605955|SUPERIORITY_OR_OTHER|||||||0.033||95.0|||||ANCOVA|p-value obtained from ANCOVA model with fixed effect terms for center and treatment, and baseline score as a covariate.||Week 12 Total Score||||0.033
72409513|NCT03509948|144327402|SUPERIORITY||Geometric Least Squares Mean|92.08|||||TWO_SIDED|90.0|88.37|95.95||||||Fed/Fasted Ratio||95.95|88.37|
72409514|NCT03509948|144327403|SUPERIORITY||Geometric Least Squares Mean|90.89|||||TWO_SIDED|90.0|84.99|97.2||||||Fed/Fasted Ratio||97.20|84.99|
72409515|NCT03509948|144327405|SUPERIORITY||Geometric Least Squares Mean|1.0|||||TWO_SIDED|90.0|0.25|1.75||||||Fed/Fasted Ratio||1.75|0.25|
72409516|NCT03509948|144327407|SUPERIORITY||Geometric Least Squares Mean|91.4|||||TWO_SIDED|90.0|87.55|95.41||||||Fed/Fasted Ratio||95.41|87.55|
72409517|NCT01129141|144327410|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.198|STANDARD_ERROR_OF_MEAN|2.88|<|0.0001|TWO_SIDED|95.0|-22.86|-11.53|||Mixed Models Analysis|||||-11.53|-22.86|<.0001
72409518|NCT01071512|144327411|OTHER|||||||0.17|||||||Mixed Models Analysis|||Analysis used all available data from subjects, including those who dropped out early.||||0.17
72538402|NCT00285012|144605955|SUPERIORITY_OR_OTHER|||||||0.078||95.0|||||ANCOVA|p-value obtained from ANCOVA model with fixed effect terms for center and treatment, and baseline score as a covariate.||Week 24 Total Score||||0.078
72538403|NCT00285012|144605955|SUPERIORITY_OR_OTHER|||||||0.023||95.0|||||ANCOVA|p-value obtained from ANCOVA model with fixed effect terms for center and treatment, and baseline score as a covariate.||Week 52 Total Score||||0.023
72538404|NCT05004181|144605973|NON_INFERIORITY|Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the GMR was greater than 0.67.|Geometric mean ratio|13.12|||||TWO_SIDED|95.0|11.14|15.45|||||GMRs and 2-sided 95% CIs were based on the analysis of logarithmically transformed neutralizing titers using a linear regression model with terms of age, sex, and group.|||15.45|11.14|
72538405|NCT05004181|144605974|NON_INFERIORITY|Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the difference of percentages was greater than -10%.|Difference in Percentages|-4.55|||||TWO_SIDED|95.0|-10.04|0.83|||||Adjusted difference in percentages were estimated using minimum risk weights and stratified by sex and age group.|||0.83|-10.04|
72538406|NCT05004181|144605976|OTHER||Difference in Percentages|36.73|||||TWO_SIDED|95.0|19.21|51.17|||||Adjusted difference was estimated using the minimum risk weights and stratified by sex and age group.|||51.17|19.21|
72575022|NCT04684238|144676157|SUPERIORITY|||||||0.637|||||||Wilcoxon (Mann-Whitney)|||Need for inotropic/vasopressor agent at \>24 hours.||||0.637
72538407|NCT03993288|144605991|NON_INFERIORITY|Non-inferiority was considered confirmed if the upper bound of the two-sided 95% confidence interval for the mean value calculated by the least squares method did not exceed the predetermined boundary of non-inferiority of 5 g/L|Mean Difference (Net)|-0.24||||0.0032|TWO_SIDED|95.0|-4.86|4.38|||ANCOVA|||||4.38|-4.86|0.0032
72538408|NCT02861534|144606011|SUPERIORITY||Hazard Ratio (HR)|0.93||||0.269|TWO_SIDED|95.0|0.81|1.06|||Cox proportional hazard model|||||1.06|0.81|0.269
72538409|NCT02861534|144606012|SUPERIORITY||Hazard Ratio (HR)|0.9||||0.048|TWO_SIDED|95.0|0.81|1.0|||Cox proportional hazard model|||||1.00|0.81|0.048
72538410|NCT02861534|144606013|SUPERIORITY||Hazard Ratio (HR)|0.9||||0.019|TWO_SIDED|95.0|0.82|0.98|||Cox proportional hazard model|||||0.98|0.82|0.019
72538411|NCT02861534|144606014|SUPERIORITY||Hazard Ratio (HR)|0.91||||0.023|TWO_SIDED|95.0|0.84|0.99|||Andersen-Gill model|||||0.99|0.84|0.023
72538412|NCT02861534|144606015|SUPERIORITY||Hazard Ratio (HR)|0.9||||0.021|TWO_SIDED|95.0|0.83|0.98|||Cox proportional hazard model|||||0.98|0.83|0.021
72409519|NCT01071512|144327412|OTHER|||||||0.6|||||||Mixed Models Analysis|||Analysis used all available data||||0.6
72538413|NCT02861534|144606016|SUPERIORITY||Hazard Ratio (HR)|0.95||||0.377|TWO_SIDED|95.0|0.84|1.07|||Cox proportional hazard model|||||1.07|0.84|0.377
72538414|NCT02861534|144606019|OTHER||Difference in Percentage|1.2||||0.121|TWO_SIDED|95.0|-0.3|2.8|||Miettinen & Nurminen method|||||2.8|-0.3|0.121
72538415|NCT02861534|144606020|OTHER||Difference in Percentage|0.6||||0.303|TWO_SIDED|95.0|-0.5|1.6|||Miettinen & Nurminen method|||||1.6|-0.5|0.303
72538416|NCT02780115|144606023|SUPERIORITY||LS Mean Diff|1.96||||0.1663|TWO_SIDED|95.0|-0.83|4.74|||ANCOVA|||||4.74|-0.83|0.1663
72538417|NCT02780115|144606023|SUPERIORITY||LS Mean Diff|4.77||||0.0009|TWO_SIDED|95.0|1.98|7.56|||ANCOVA|||||7.56|1.98|0.0009
72538418|NCT02780115|144606023|SUPERIORITY||LS Mean Diff|4.54||||0.0014|TWO_SIDED|95.0|1.79|7.29|||ANCOVA|||||7.29|1.79|0.0014
72538419|NCT02780115|144606023|SUPERIORITY||LS Mean Diff|4.81||||0.0008|TWO_SIDED|95.0|2.03|7.58|||ANCOVA|||||7.58|2.03|0.0008
72575023|NCT02585934|144676165|SUPERIORITY||least square mean difference|-0.36||||0.2249|TWO_SIDED|95.0|-0.95|0.22||the threshold for statistical significance was p=0.05|Mixed Models Analysis|Statistical Method: Mixed model for repeated measures||||0.22|-0.95|0.2249
72538420|NCT02742818|144606049|OTHER|||||||0.19|||||||Generalized Estimation Equations (GEE)|Model assuming Gaussian distribution and AR-1 correlation structure, considering repeated measures in time.|||Through inference, changes in body temperature and proportional occurrence of hypothermia during surgery were evaluated using general models of estimating equations (GEE, Liang e Zeger, 1986). Binominal and normal distributions were taken into account, respectively, and assumptions for errors normalities were verified using residual plot graphs and fitted values. The significance of other associated factors and probable outcomes were verified, including gender, age, surgery type and total surgery duration, in minutes. Since analyses were longitudinal, AR-1 working correlation matrix was created.|||0.190
72538421|NCT02742818|144606050|OTHER|||||||0.82|||||||Wilcoxon (Mann-Whitney)|||||||0.820
72538422|NCT02742818|144606051|OTHER|||||||0.529|||||||Chi-squared|||||||0.529
72538423|NCT02742818|144606052|OTHER|||||||0.999|||||||Chi-squared|||||||0.999
72575024|NCT02585934|144676166|SUPERIORITY||least square mean difference|-0.09||||0.826|TWO_SIDED|95.0|-0.9|0.72||the threshold for statistical significance was p=0.05|Mixed Models Analysis|Statistical Method: Mixed model for repeated measures||||0.72|-0.90|0.8260
72409520|NCT01071512|144327413|OTHER|||||||0.3|||||||Mixed Models Analysis|||Analysis used all available data||||0.3
72409521|NCT01071512|144327414|OTHER|||||||0.02|||||||Mixed Models Analysis|||Analysis used all available data||||0.02
72409522|NCT01071512|144327415|OTHER|||||||0.9|||||||Mixed Models Analysis|||Analysis used all available data||||0.9
72538424|NCT02742818|144606053|OTHER|||||||0.462|||||||Wilcoxon (Mann-Whitney)|||||||0.462
72538425|NCT01785472|144606068|NON_INFERIORITY_OR_EQUIVALENCE|The statistical test was made at a one-sided significance level of 0.025.|least Square Means net difference|-2.33|STANDARD_ERROR_OF_MEAN|0.85|<|0.001||95.0|-4.0|-0.66|||ANCOVA|||||-0.66|-4.00|<0.001
72538426|NCT01211873|144606081|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|||||||<0.001
72538427|NCT01211873|144606082|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|||||||<0.001
72538428|NCT01211873|144606082|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|||||||<0.001
72538429|NCT01211873|144606083|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|||||||<0.001
72538430|NCT01211873|144606083|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|||||||<0.001
72538431|NCT01294709|144606087|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-6.9|||||TWO_SIDED|90.0|-17.66|3.86|||mixed effects model|mixed effects model with MK-0974 pooled over doses||Telcagepant minus Placebo Treatment Difference||3.86|-17.66|
72538432|NCT01294709|144606088|SUPERIORITY_OR_OTHER||Difference in Least squares meand|-0.056|||||TWO_SIDED|90.0|-0.19|0.076|||mixed effects model|mixed effects model with MK-0974 pooled over doses||Telcagepant minus Placebo Treatment Difference||0.076|-0.19|
72575025|NCT02585934|144676167|SUPERIORITY||least square mean difference|-0.12||||0.0234|TWO_SIDED|95.0|-0.22|-0.02||the threshold for statistical significance was p=0.05|Mixed Models Analysis|Statistical Method: Mixed model for repeated measures||||-0.02|-0.22|0.0234
72409523|NCT02076412|144327435|SUPERIORITY||Risk Difference (RD)|13.8||||0.1519|TWO_SIDED|95.0|0.5|27.1|||Fisher Exact||Confidence interval for treatment difference (risk difference) was based on the normal approximation|||27.1|0.5|0.1519
72538433|NCT01294709|144606089|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-7.14|||||TWO_SIDED|90.0|-22.03|7.74|||mixed effects model|mixed effects model with MK-0974 pooled over doses||Telcagepant minus Placebo Treatment Difference||7.74|-22.03|
72538434|NCT01612780|144606099|SUPERIORITY||||||<|0.0001||||||Values of p \<0.05 were deemed statistically significant.|t-test, 2 sided|||Study sample size was established to test the hypothesis that the mean SNOT-20 score is reduced by at least 0.8 points from baseline to 1 year post procedure. Using this delta, a 1-sided alpha of 0.25, and 90% power, a sample size of 19 participants was adequate to test the hypothesis.||||<0.0001
72538435|NCT03466060|144606104|SUPERIORITY||Posterior mean difference|-2.1|STANDARD_DEVIATION|2.23|||TWO_SIDED|95.0|-6.4|2.3||95% credible intervals are used to determine whether Test and Control solutions are statistically significantly different at each time point.|bayesian multivariate hierarachical||Posterior mean difference was calculated as Test-Control.|1-Minute Follow-up Analysis||2.3|-6.4|
72538436|NCT03466060|144606104|SUPERIORITY||Posertior Mean Difference|-2.5|STANDARD_DEVIATION|2.16|||TWO_SIDED|95.0|-6.8|1.7||95% credible intervals are used to determine whether Test and Control solutions are statistically significantly different at each time point.|Bayesian Multivariate Hierarchical Model||Posterior mean difference was calculated as Test-Control.|5-minute Follow-up Analysis||1.7|-6.8|
72538437|NCT03466060|144606104|SUPERIORITY||Posterior Mean Difference|-2.7|STANDARD_DEVIATION|2.1|||TWO_SIDED|95.0|-6.9|1.5||95% credible intervals are used to determine whether Test and Control solutions are statistically significantly different at each time point.|Bayesian multivariate hierarchical model||Posterior mean difference was calculated as Test-Control.|45-Minute Follolw-up Analysis||1.5|-6.9|
72538438|NCT03466060|144606104|SUPERIORITY||Posterior Mean Difference|-2.5|STANDARD_DEVIATION|2.01|||TWO_SIDED|95.0|-6.5|1.4|||Bayesian Multivariate Heirarchical Model||Posterior mean difference was calculated as Test-Control.|2-Hour Follow-up Analysis||1.4|-6.5|
72409524|NCT02076412|144327440|SUPERIORITY||Risk Difference (RD)|-0.01||||0.4927|TWO_SIDED|95.0|-0.05|0.02||P-value from a two-sided two-sample t-test, testing for a difference in means between fostamatinib and placebo.|t-test, 2 sided|||||0.02|-0.05|0.4927
72409525|NCT02076412|144327441|SUPERIORITY||Risk Difference (RD)|-0.12||||0.2499|TWO_SIDED|95.0|-0.32|0.09||P-value from a two-sided two-sample t-test, testing for a difference in means between fostamatinib and placebo.|t-test, 2 sided|||||0.09|-0.32|0.2499
72409526|NCT02755831|144327458|SUPERIORITY||||||<|0.05|||||||Fisher Exact|||Fisher's Exact Test||||<0.05
72409527|NCT02755831|144327459|OTHER||||||<|0.05|||||||Friedman test|Friedman's test was used to analyze differences with a post hoc Wilcoxon Ranked Sign test to compare differences at individual time points.||||||<.05
72409528|NCT02755831|144327460|OTHER||||||<|0.05|||||||Friedman|Friedman's test was used to analyze differences with a post hoc Wilcoxon Ranked Sign test to compare differences at individual time points.||||||<0.05
72409529|NCT02755831|144327461|OTHER||||||<|0.05|||||||Friedman Test|Friedman's test was used to analyze differences with a post hoc Wilcoxon Ranked Sign test to compare differences in treatment group only.||||||<0.05
72538439|NCT03466060|144606104|SUPERIORITY||Posterior Mean Difference|-1.1|STANDARD_DEVIATION|2.28|||TWO_SIDED|95.0|-5.8|3.1|||Bayesian Multivariate Heirarchical Model||Posterior mean difference was calculated as Test-Control.|1-Minute Follow-up Analysis||3.1|-5.8|
72538440|NCT03466060|144606104|SUPERIORITY|95% credible intervals are used to determine whether Test and Control solutions are statistically significantly different at each time point.|Posterior Mean Difference|-0.7|STANDARD_DEVIATION|2.2|||TWO_SIDED|95.0|-5.0|3.6|||Bayesian Multivariate Heirarchical Model||Posterior mean difference was calculated as Test-Control.|5-Minute Follow-up Analysis||3.6|-5.0|
72538441|NCT03466060|144606104|NON_INFERIORITY|95% credible intervals are used to determine whether Test and Control solutions are statistically significantly different at each time point.|Posterior Mean Difference|-2.0|STANDARD_DEVIATION|2.16|||TWO_SIDED|95.0|-6.4|2.3|||Bayesian Multivariate Hierarchical Model||Posterior mean difference was calculated as Test-Control.|45-Minute Follow-up Analysis||2.3|-6.4|
72538442|NCT03466060|144606104|SUPERIORITY||Posterior Mean Difference|-1.5|STANDARD_DEVIATION|2.1|||TWO_SIDED|95.0|-5.8|2.5||95% credible intervals are used to determine whether Test and Control solutions are statistically significantly different at each time point.|Bayesian Mutlivariate Hiearachical Model||Posterior mean difference was calculated as Test-Control.|2-Hour Follow-up Analysis||2.5|-5.8|
72409530|NCT02755831|144327462|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|T-test used to compare mean difference in hospital costs at time of delivery.||||||<0.05
72409531|NCT02442830|144327473|OTHER|Log rank test||||||0.002|||||||Log Rank|||||||.002
72409532|NCT01516879|144327475|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-56.97|STANDARD_ERROR_OF_MEAN|2.1|<|0.001|TWO_SIDED|95.0|-61.08|-52.85|||Repeated measures linear effects model|The model included treatment group, stratification factor, scheduled visit and the interaction of treatment with scheduled visit as covariates.|Treatment difference using placebo as the reference.|The null hypothesis was that there was no mean difference in the percent change from Baseline at Week 52 in LDL-C between evolocumab 420 mg and placebo, and the alternative hypothesis was that a mean difference did exist.||-52.85|-61.08|<0.001
72409533|NCT01516879|144327476|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-57.8|STANDARD_ERROR_OF_MEAN|2.3|<|0.001|TWO_SIDED|95.0|-62.3|-53.3|||Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit and the interaction of treatment with scheduled visit as covariates.|Treatment difference using placebo as the reference.|||-53.3|-62.3|<0.001
72409534|NCT01516879|144327477|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|75.8|||<|0.001|TWO_SIDED|95.0|70.8|79.7|||Cochran-Mantel-Haenszel|CMH test stratified by the stratification factor. For testing, non-achievement was imputed for participants with a missing value at Week 52.|Treatment difference using placebo as the reference.|||79.7|70.8|<0.001
72409535|NCT01516879|144327478|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-57.51|STANDARD_ERROR_OF_MEAN|1.56|<|0.001|TWO_SIDED|95.0|-60.57|-54.45|||Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit and the interaction of treatment with scheduled visit as covariates.|Treatment difference using placebo as the reference.|||-54.45|-60.57|<0.001
72409536|NCT01516879|144327479|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-35.15|STANDARD_ERROR_OF_MEAN|1.04|<|0.001|TWO_SIDED|95.0|-37.19|-33.11|||Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit and the interaction of treatment with scheduled visit as covariates.|Treatment difference using placebo as the reference.|||-33.11|-37.19|<0.001
72409537|NCT01516879|144327480|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-33.45|STANDARD_ERROR_OF_MEAN|1.41|<|0.001|TWO_SIDED|95.0|-36.21|-30.68|||Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit and the interaction of treatment with scheduled visit as covariates.|Treatment difference using placebo as the reference.|||-30.68|-36.21|<0.001
72409538|NCT01516879|144327481|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-50.27|STANDARD_ERROR_OF_MEAN|2.03|<|0.001|TWO_SIDED|95.0|-54.25|-46.28|||Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit and the interaction of treatment with scheduled visit as covariates.|Treatment difference using placebo as the reference.|||-46.28|-54.25|<0.001
72409539|NCT01516879|144327482|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-44.21|STANDARD_ERROR_OF_MEAN|1.71|<|0.001|TWO_SIDED|95.0|-47.56|-40.85|||Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit and the interaction of treatment with scheduled visit as covariates.|Treatment difference using placebo as the reference.|||-40.85|-47.56|<0.001
72538443|NCT02964910|144606119|NON_INFERIORITY|The criteria of the immunogenicity non-inferiority between CHB group and healthy adults group were: the lower limit of 95% CI of the seroconversion rate difference was not less than -10%.|the seroconversion rate difference(%)|-2.08|||||TWO_SIDED|95.0|-5.23|0.22||||||||0.22|-5.23|
72538444|NCT02964910|144606120|NON_INFERIORITY|The criteria of the immunogenicity non-inferiority between CHB group and healthy adults group were: the lower limit of 95%CI of the GMC ratio was not lower than 0.5.|GMC ratio|0.69|||||TWO_SIDED|95.0|0.55|0.85||||||||0.85|0.55|
72538445|NCT02964910|144606124|OTHER|The differences in incidence rate of ADR\\AE between the two groups were compared.||||||0.778|||||||Chi-squared|||||||0.778
72538446|NCT02964910|144606125|OTHER|The differences in incidence rate of ADR\\AE between the two groups were compared.||||||0.728|||||||Chi-squared|||||||0.728
72538447|NCT02964910|144606126|OTHER|The differences in incidence rate of ADR\\AE between the two groups were compared.||||||0.949|||||||Chi-squared|||||||0.949
72538448|NCT02964910|144606127|OTHER|The differences in incidence rate of ADR\\AE between the two groups were compared.||||||0.614|||||||Chi-squared|||||||0.614
72538449|NCT02964910|144606128|OTHER|The differences in incidence rate of ADR\\AE between the two groups were compared.||||||0.956|||||||Chi-squared|||||||0.956
72538450|NCT04007406|144606129|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0||||The threshold value for statistical significance was p\<0.05|Mixed Models Analysis|||||||<0.0001
72575026|NCT02585934|144676168|SUPERIORITY||least square mean difference|0.12||||0.2096|TWO_SIDED|95.0|-0.07|0.32||the threshold for statistical significance was p=0.05|Mixed Models Analysis|Statistical Method: Mixed model for repeated measures||||0.32|-0.07|0.2096
72575027|NCT02585934|144676169|SUPERIORITY||least square mean difference|-0.14||||0.765|TWO_SIDED|95.0|-1.09|0.8||the threshold for statistical significance was p=0.05|Mixed Models Analysis|Statistical Method: Mixed model for repeated measures||||0.80|-1.09|0.7650
72575028|NCT02585934|144676170|SUPERIORITY||least square mean difference|-0.38||||0.2472|TWO_SIDED|95.0|-1.03|0.27||the threshold for statistical significance was p=0.05|Mixed Models Analysis|Statistical Method: Mixed model for repeated measures||||0.27|-1.03|0.2472
72575029|NCT00110136|144676189|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.81|STANDARD_DEVIATION|2.02||0.2629|TWO_SIDED|95.0|-2.36|0.74||Paired t-test; no adjustments for multiple comparisons|paired t-test||The difference is post minus pre so negative values represents fewer hot flashes after treatment.|Analysis of the change in hot flash frequency from baseline to four weeks; null hypothesis is no change.||0.74|-2.36|0.2629
72575030|NCT00110136|144676190|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.37|STANDARD_DEVIATION|7.91||0.1365|TWO_SIDED|95.0|-10.45|1.72||Paired t-test; unadjusted for multiple comparisons.|paired t-test||Difference in hot flash score is post minus pre so a negative value represents a decrease in the frequency and/or severity of the hot flashes.|Assessment of the change in the hot flash score over time||1.72|-10.45|0.1365
72575031|NCT00110136|144676192|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.54|STANDARD_DEVIATION|7.0||0.832|TWO_SIDED|95.0|-4.84|5.92||Paired t-test; unadjusted for multiple comparisons.|paired t-test||This is the change in MCS from baseline to four weeks (post minus pre) so values greater than zero reflect improvement in QOL.|Assess the change in MCS from baseline to four weeks in patients receiving St. John's wort.||5.92|-4.84|0.8320
72575032|NCT00110136|144676193|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0|STANDARD_DEVIATION|7.43||0.9995|TWO_SIDED|95.0|-5.71|5.71||Paired t-test on the change in PCS from baseline to four weeks; unadjusted for multiple comparisons.|paired t-test||This is the change in PCS from baseline to four weeks (post minus pre), so positive numbers represent improvement in QOL.|Assess the change in PCS from baseline to four weeks; null hypothesis is no change.||5.71|-5.71|0.9995
72575033|NCT00110136|144676194|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.35|STANDARD_DEVIATION|7.12||0.1042|TWO_SIDED|95.0|-1.12|9.822||Paired t-test; unadjusted for multiple comparisons.|paired t-test||This is the change in mood from baseline to four weeks (post minus pre). Mood is scored so that higher numbers represent better mood so positive changes represent an improvement in mood.|Assess the change in mood from baseline to four weeks. Null hypothesis is no change.||9.822|-1.12|0.1042
72576799|NCT00261443|144680653|SUPERIORITY_OR_OTHER_LEGACY||Difference|-1.15||||0.164|TWO_SIDED|95.0|-2.77|0.47||Baseline: ANOVA model, controlling for treatment, mood stabilizer, and index mood episode. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 36 Comparison||0.47|-2.77|0.164
72576800|NCT00261443|144680653|SUPERIORITY_OR_OTHER_LEGACY||Difference|-1.53||||0.066|TWO_SIDED|95.0|-3.16|0.1||Baseline: ANOVA model, controlling for treatment, mood stabilizer, and index mood episode. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 40 Comparison||0.10|-3.16|0.066
72538451|NCT04007406|144606130|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0||||The threshold for significance was p \<0.05|Mixed Models Analysis|||||||<0.0001
72538452|NCT04007406|144606131|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0||||The threshold for significance was p \<0.05|Mixed Models Analysis|||||||<0.0001
72538453|NCT04007406|144606132|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0||||The threshold for significance was p \<0.05|Mixed Models Analysis|||||||<0.0001
72538454|NCT04007406|144606133|SUPERIORITY||||||<|0.0001||||||The statistical threshold was p\<0.05|Mixed Models Analysis|||||||<0.0001
72538455|NCT02072174|144606144|SUPERIORITY|||||||0.0242|||||||Kruskal-Wallis|||||||0.0242
72538456|NCT02072174|144606145|SUPERIORITY|||||||0.0026|||||||Cochran-Mantel-Haenszel|||patient diary data||||0.0026
72538457|NCT02072174|144606145|SUPERIORITY|||||||0.0127|||||||Cochran-Mantel-Haenszel|||doctor's examination data||||0.0127
72538458|NCT02072174|144606146|SUPERIORITY|||||||0.0394||||||"The p-value associated with treatment factor of variable on day 2, 3, 4 and 5 between Anaferon for Children and Placebo. Model includes treatment, visit, treatment\*visit interaction, Day 1 covariate. Treatment\*visit interaction p-value is 0.3220."|Mixed Models Analysis|||||||0.0394
72538459|NCT02072174|144606146|SUPERIORITY|||||||0.322||||||"The p-value associated with treatment\*visit interaction factor of variable on day 2, 3, 4 and 5 between Anaferon for Children and Placebo. Model includes treatment, visit, treatment\*visit interaction, Day 1 covariate."|Mixed Models Analysis|||||||0.3220
72538460|NCT02072174|144606147|SUPERIORITY|||||||0.0043|||||||Cochran-Mantel-Haenszel|||||||0.0043
72538461|NCT02072174|144606148|SUPERIORITY|||||||0.0104||||||p-value not adjusted for multiple comparisons|Kruskal-Wallis|||Day 2 (patient diary data)||||0.0104
72538462|NCT02072174|144606148|SUPERIORITY|||||||0.0041||||||p-value not adjusted for multiple comparisons|Kruskal-Wallis|||Day 3 (patient diary data)||||0.0041
72538463|NCT02072174|144606148|SUPERIORITY|||||||0.0484||||||p-value not adjusted for multiple comparisons|Kruskal-Wallis|||Day 4 (patient diary data)||||0.0484
72538464|NCT02072174|144606148|SUPERIORITY|||||||0.0603||||||p-value not adjusted for multiple comparisons|Kruskal-Wallis|||Day 5 (patient diary data)||||0.0603
72538465|NCT02072174|144606148|SUPERIORITY|||||||0.0056||||||p-value not adjusted for multiple comparisons|Kruskal-Wallis|||Day 3 (doctor's examination)||||0.0056
72575034|NCT04540406|144676195|OTHER|We employed covariate-adjusted Principal Coordinates Analysis and a subject-stratified PERMANOVA test to assess the overall gut microbiota structural change. These tests are generally neither superiority, non-inferiority, nor equivalence tests. Instead, they are used to detect and evaluate overall differences in the microbial community structure between groups or conditions.||||||||||||||||PCoA (Principal Coordinates Analysis) + PERMANOVA (Permutational Multivariate Analysis of Variance) are exploratory multivariate techniques commonly used in microbiome research to assess and visualize differences in community composition. The null hypothesis for PERMANOVA is that there are no differences in the centroids (multivariate means) of the groups being compared. The microbial communities in different groups or conditions are not significantly different from each other.|To assess the overall structural changes in gut microbiota, we employed covariate-adjusted Principal Coordinates Analysis (PCoA) and a subject-stratified PERMANOVA test. PCoA, an exploratory multivariate technique, helps visualize and interpret patterns in complex microbiome data by reducing dimensionality, with the first principal coordinate (PC1) capturing the largest variation among samples. PERMANOVA, which does not rely on standard parametric assumptions, was used to determine if there are statistically significant differences in the overall composition of microbial communities between groups based on a chosen distance metric. Our analysis aimed to explore whether microbial community compositions differed significantly between Day 0 and Day 28 within the Treatment group, accounting for inter-individual variability. Similarly, we investigated if such differences existed over the same time points in the Control group. The unit of measure was distance metrics.|||
72575035|NCT03400943|144676212|SUPERIORITY||Risk Difference (RD)|0.56|||<|0.0001|TWO_SIDED|95.0|0.33|0.78|||Cochran-Mantel-Haenszel||Number of subjects per treatment: 41 (Vilaprisan) / 20 (Placebo).|Vilaprisan (A1) and Vilaprisan+Placebo (B2) combined vs. Placebo+Vilaprisan (B1) in treatment period 1||0.78|0.33|<.0001
72409540|NCT01516879|144327483|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-37.14|STANDARD_ERROR_OF_MEAN|1.67|<|0.001|TWO_SIDED|95.0|-40.41|-33.87|||Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit and the interaction of treatment with scheduled visit as covariates.|Treatment difference using placebo as the reference.|||-33.87|-40.41|<0.001
72538466|NCT02072174|144606148|SUPERIORITY|||||||0.0994||||||p-value not adjusted for multiple comparisons|Kruskal-Wallis|||Day 5 (doctor's examination)||||0.0994
72538467|NCT02072174|144606149|SUPERIORITY|||||||0.0084|||||||Kruskal-Wallis|||Days 1-7 (patient diary data)||||0.0084
72538468|NCT02072174|144606149|SUPERIORITY|||||||0.0233|||||||Kruskal-Wallis|||Days 1, 3, 5 and 7 (doctor's examination)||||0.0233
72538469|NCT02072174|144606150|SUPERIORITY|||||||0.0721|||||||Mixed Models Analysis|||||||0.0721
72538470|NCT02072174|144606151|SUPERIORITY|||||||0.0001|||||||Mixed Models Analysis|||||||0.0001
72538471|NCT02072174|144606152|SUPERIORITY|||||||0.3383|||||||Fisher Exact|||||||0.3383
72538472|NCT05674721|144606154|EQUIVALENCE|The bioequivalence between Treatment A (test) and Treatment B (reference) under fasted conditions would be declared as per Food and Drug Administration (FDA) requirements if the 90 percent (%) confidence intervals (CIs) for the ratio of the geometric means of Cmax were between 80% and 125%.|Ratio of Geometric Least Square Mean|95.13|||||TWO_SIDED|90.0|88.31|102.47||||||||102.47|88.31|
72538473|NCT05674721|144606155|EQUIVALENCE|The bioequivalence between Treatment A (test) and Treatment B (reference) under fasted conditions would be declared as per FDA if the 90% CIs for the ratio of the geometric means of Cmax were between 80% and 125%.|Ratio of Geometric Least Square Mean|102.51|||||TWO_SIDED|90.0|93.54|112.35||||||||112.35|93.54|
72538474|NCT05674721|144606156|EQUIVALENCE|The bioequivalence between Treatment A (test) and Treatment B (reference) under fasted conditions would be declared as per FDA if the 90% CIs for the ratio of the geometric means of AUC0-t were between 80% and 125%.|Ratio of Geometric Least Square Mean|99.15|||||TWO_SIDED|90.0|96.76|101.61||||||||101.61|96.76|
72538475|NCT05674721|144606157|EQUIVALENCE|The bioequivalence between Treatment A (test) and Treatment B (reference) under fasted conditions would be declared as per FDA if the 90% CIs for the ratio of the geometric means of AUC0-t were between 80% and 125%.|Ratio of Geometric Least Square Mean|102.62|||||TWO_SIDED|90.0|98.15|107.3||||||||107.30|98.15|
72538476|NCT05674721|144606158|EQUIVALENCE|The bioequivalence between Treatment A (test) and Treatment B (reference) under fasted conditions would be declared as per FDA if the 90% CIs for the ratio of the geometric means of AUC0-inf were between 80% and 125%.|Ratio of Geometric Least Square Mean|99.2|||||TWO_SIDED|90.0|96.82|101.63||||||||101.63|96.82|
72538477|NCT05674721|144606159|EQUIVALENCE|The bioequivalence between Treatment A (test) and Treatment B (reference) under fasted conditions would be declared as per FDA if the 90% CIs for the ratio of the geometric means of AUC0-inf were between 80% and 125%.|Ratio of Geometric Least Square Mean|102.73|||||TWO_SIDED|90.0|98.31|107.34||||||||107.34|98.31|
72538478|NCT04466956|144606183|OTHER|Statistical analysis was by intention-to-treat including all randomised participants, using Stata-12 software. Continuous data were summarised as mean and standard deviation, and categorical data as counts and percentages. Between group differences were reported with 95% confidence intervals, and p-values, using t-test to compare normally distributed data and chi-squared tests to compare categorical data.|||||<|0.01|TWO_SIDED|95.0||||Between group differences were reported with 95% confidence intervals, and p-values, using t-test to compare normally distributed data and chi-squared tests to compare categorical data.|t-test, 1 sided|||Mean worst pain scores were 5.98 and 6.88 in the standard care and VR groups respectively, with difference in means -0.9 (95% CI -2.1 - 0.28), p value 0.13. Mean anxiety scores at the end of the procedure were 3.94 and 4.4 in the standard care and VR groups respectively, with difference in means -0.46 (95% CI -2.1, 1.1), p value 0.57.||||<0.01
72538479|NCT00091507|144606184|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.88||||0.28|TWO_SIDED|95.0|0.66|1.13|||Regression, Logistic|||||1.13|0.66|0.28
72538480|NCT00091507|144606185|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.56||||0.08|TWO_SIDED|95.0|0.3|1.07|||Regression, Logistic|||||1.07|0.30|0.08
72538481|NCT00091507|144606186|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.73||||0.24|TWO_SIDED|95.0|0.43|1.23|||Regression, Logistic|||||1.23|0.43|0.24
72538482|NCT00091507|144606187|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.72||||0.27|TWO_SIDED|95.0|0.4|1.29|||Regression, Logistic|||||1.29|0.40|0.27
72538483|NCT00091507|144606188|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.48||||0.01|TWO_SIDED|95.0|0.27|0.85|||Regression, Logistic|||||0.85|0.27|0.01
72538484|NCT01393626|144606211|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.86||||0.3249|TWO_SIDED|95.0|-7.64|21.36|||Cochran-Mantel-Haenszel|||Tofacitinib-Placebo||21.36|-7.64|0.3249
72575036|NCT02563106|144676219|OTHER|The analysis of the primary endpoint was based on the mITT analysis set. Per-protocol and worse case analyses were performed as sensitivity analyses.The P-value was based on a one-sided z-test for the comparison of the treatment difference between the SYN-004 group and the Placebo group.|Relative Risk Reduction (%)|71.4||||0.045|TWO_SIDED|95.0|-35.9|94.0||Study was designed to provide 80% power to detect treatment effect with one-sided alpha = 0.05 on the primary endpoint. Based on the pre-specified z-test the one-sided P=0.045.|z-test|1-sided P=0.045.|Relative Risk Reduction in SYN-004 group compared to Placebo group.|The Modified Intent-to-Treat (mITT) analysis set included randomized subjects who received at least 1 dose of study drug. Number of subjects with CDI, imputing early termination without CDI as not being treatment failures.||94.0|-35.9|0.045
72575037|NCT00537303|144676243|NON_INFERIORITY_OR_EQUIVALENCE|The two treatments are declared equivalent if the 95% Confidence Interval for the estimated difference in means between the two treatment groups is included in the interval from -0.4 to 0.4 for both the full analysis set and the per protocol set|Mean Difference (Final Values)|0.06||||0.606||95.0|-0.17|0.29||P-value for test of difference between treatments.|ANCOVA|Regimen, country and previous oral antidiabetic drug (OAD) use as factors and baseline HbA1c as covariate.||Equivalence analysis with a null hypothesis stating that there is a difference between Advanced and Basic treatment groups of more than 0.4%.||0.29|-0.17|0.606
72627348|NCT05136170|144783683|SUPERIORITY|"Changes from baseline in each IDEEL modules scale score was analyzed using a mixed model for repeated measures (MMRM)adjusting by gender, age class, IDEEL module baseline value, treatment, visit and treatment by visit interaction. Subject was considered as a random effect. The covariance matrix used was unstructured. Comparisons vs vehicle TID were provided using least square means at each visit and overall."|LS means difference|1.976||||0.582|TWO_SIDED|95.0|-5.065|9.017||P-value of LS means difference between treatments from the MMRM on change from baseline in IDEEL DE Treatment Satisfaction \& Bother module (Satisfaction with Treatment Effectiveness) at Week 12.|Mixed Model for Repeated Measures|||TS (Treatment - in general) - Week 12||9.017|-5.065|0.582
72538485|NCT01393626|144606211|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.36||||0.3916|TWO_SIDED|95.0|-8.09|20.8|||Cochran-Mantel-Haenszel|||Tofacitinib-Placebo||20.80|-8.09|0.3916
72538486|NCT03506425|144606247|OTHER|||||||0.32|||||||t-test, 2 sided|||||||0.32
72538487|NCT03506425|144606248|OTHER|||||||0.08|||||||ANOVA|||||||0.08
72538488|NCT03506425|144606249|OTHER|||||||0.83|||||||ANOVA|||||||0.83
72538489|NCT02643394|144606252|SUPERIORITY|||||||0.252|TWO_SIDED|80.0|||||Wilcoxon (Mann-Whitney)|||||||0.252
72538490|NCT02643394|144606253|SUPERIORITY|||||||0.402|||||||Wilcoxon (Mann-Whitney)|||||||0.402
72538491|NCT04193033|144606279|SUPERIORITY|||||||0.001|||||||Linear Growth Curve Model|||||||0.001
72538492|NCT04193033|144606280|SUPERIORITY|||||||0.012|||||||t-test, 2 sided|||||||0.012
72538493|NCT04193033|144606281|SUPERIORITY|||||||0.66|||||||ANOVA|||||||0.66
72538494|NCT04193033|144606283|SUPERIORITY|||||||0.49|||||||Linear Growth Curve Model|Time was included as a fixed effect and both time and intercept were included as random effects.||||||.49
72538495|NCT04193033|144606285|SUPERIORITY|||||||0.06||||||Paired t-test, alpha = .05.|t-test, 2 sided|||||||0.06
72538496|NCT00118209|144606312|SUPERIORITY||Hazard Ratio (HR)|0.93||||0.6519|TWO_SIDED|95.0|0.68|1.27|||Log Rank|||||1.27|0.68|0.6519
72538497|NCT00118209|144606313|SUPERIORITY|||||||0.67|||||||t-test, 2 sided|||||||0.67
72538498|NCT00118209|144606314|SUPERIORITY||Hazard Ratio (HR)|1.09||||0.6414|TWO_SIDED|95.0|0.75|1.59|||Log Rank|||||1.59|0.75|0.6414
72538499|NCT03083639|144606319|EQUIVALENCE|The bioequivalence between esomeprazole capsules (Regimen A) and esomeprazole tablets (Regimen B) was assessed for the natural logarithms of AUC∞ using analysis of variance (ANOVA) models. The models included regimen, period, and sequence as fixed effects and participant nested within sequence as a random effect. Within ANOVA framework, point estimates and their 90 percent (%) confidence intervals (CIs) for the ratio of AUC central values between esomeprazole capsules and tablets are presented.|Point estimate|1.018|||||TWO_SIDED|90.0|0.969|1.07||||||||1.070|0.969|
72538500|NCT03083639|144606320|EQUIVALENCE|The bioequivalence between esomeprazole capsules (Regimen A) and esomeprazole tablets (Regimen B) was assessed for the natural logarithms of AUCt using ANOVA models. The models included regimen, period, and sequence as fixed effects and participant nested within sequence as a random effect. Within ANOVA framework, point estimates and their 90% CIs for the ratio of AUC central values between esomeprazole capsules and tablets are presented.|Point estimate|0.993|||||TWO_SIDED|90.0|0.939|1.05||||||||1.050|0.939|
72538501|NCT03083639|144606321|EQUIVALENCE|The bioequivalence between esomeprazole capsules (Regimen A) and esomeprazole tablets (Regimen B) was assessed for the natural logarithms of Cmax using ANOVA models. The models included regimen, period, and sequence as fixed effects and participant nested within sequence as a random effect. Within ANOVA framework, point estimates and their 90% CIs for the ratio of Cmax central values between esomeprazole capsules and tablets are presented.|Point estimate|0.942|||||TWO_SIDED|90.0|0.88|1.009||||||||1.009|0.880|
72538502|NCT00981019|144606343|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Chi-squared|||"Study was exploratory, thus no hypotheses had been formalized beforehand.~To analyze repeated measures outcomes (e.g., effect of the four different statistic scenarios on doctors' recommendation of screening, their judgment of screening's effectiveness, etc.), we used the McNemar chi-square test and the Wilcoxon signed-rank test.~To test for order effects (scenarios were randomly presented)Pearson's chi-square test and the Mann-Whitney U test were used."||||<0.05
72538503|NCT03940742|144606350|OTHER||Ratio of geometric least squares mean|1.08|||||TWO_SIDED|90.0|0.879|1.32||||||||1.32|0.879|
72538504|NCT03940742|144606350|OTHER||Ratio of geometric least squares mean|0.96|||||TWO_SIDED|90.0|0.79|1.17||||||||1.17|0.790|
72538505|NCT03940742|144606350|OTHER||Ratio of geometric least squares mean|0.852|||||TWO_SIDED|90.0|0.699|1.04||||||||1.04|0.699|
72538506|NCT03940742|144606351|OTHER||Ratio of geometric least squares mean|0.916|||||TWO_SIDED|90.0|0.726|1.16||||||||1.16|0.726|
72538507|NCT03940742|144606351|OTHER||Ratio of geometric least squares mean|1.0|||||TWO_SIDED|90.0|0.802|1.25||||||||1.25|0.802|
72538508|NCT03940742|144606351|OTHER||Ratio of geometric least squares mean|0.972|||||TWO_SIDED|90.0|0.784|1.21||||||||1.21|0.784|
72575038|NCT00537303|144676244|NON_INFERIORITY_OR_EQUIVALENCE|The two treatments are declared equivalent if the 95% Confidence Interval for the estimated difference in means between the two treatment groups is included in the interval from -0.4 to 0.4 for both the Full Analysis Set and the Per Protocol set.|Mean Difference (Final Values)|0.03||||0.816||95.0|-0.21|0.26||P-value for test of difference between treatments.|ANCOVA|||Equivalence analysis with a null hypothesis stating that there is a difference between Advanced and Basic treatment groups of more than 0.4%.||0.26|-0.21|0.816
72575039|NCT04091659|144676257|EQUIVALENCE|To determine if the two training approaches were comparable to one another a margin of +/- 1 was used in differences of both OOKS and OOAS scale scores based on previously established literature. An equivalence test of differences using two one-sided tests on data from a cluster-randomized design was conducted using structural equation modeling. Sample sizes of 35 and 57 in group two, obtained by sampling 9 clusters, achieve 85% power to detect equivalence. The significance level is 0.05.|Mean Difference (Final Values)|-0.18||||0.65|TWO_SIDED|95.0|-0.85|0.49|||SEM||||The control group, standard education was the reference for this model.|0.49|-0.85|0.65
72538509|NCT02032823|144606352|SUPERIORITY||Hazard Ratio (HR)|0.581||||7.3e-06|TWO_SIDED|99.5|0.409|0.816||A multiple testing procedure is employed across the primary and all key secondary endpoints to strongly control overall type I error at 5% (2 sided) accounting for all analysis timepoints.|Log Rank|Log rank test is stratified by chemotherapy type, hormone receptor status, and prior platinum therapy using a pre-specified pooling strategy.|Estimate of the treatment hazard ratio is based on a stratified Cox's Proportional Hazards Model, \<1 indicates a lower risk with olaparib compared with placebo arm. Stratification factors are the same as those used in the stratified log-rank test.|||0.816|0.409|0.0000073
72575040|NCT04091659|144676258|EQUIVALENCE|To determine if the two training approaches were comparable to one another a margin of +/- 1 was used in differences of both OOKS and OOAS scale scores based on previously established literature. An equivalence test of differences using two one-sided tests on data from a cluster-randomized design was conducted using structural equation modeling. Sample sizes of 35 and 57 in group two, obtained by sampling 9 clusters, achieve 85% power to detect equivalence. The significance level is 0.05.|Mean Difference (Final Values)|0.26||||0.02|TWO_SIDED|95.0|0.02|0.5|||SEM||The control group, standard education, was the reference|||0.50|0.02|0.02
72575041|NCT03149445|144676322|SUPERIORITY||LS Mean Difference|-5.4||||0.1045|TWO_SIDED|95.0|-12.3|1.5||P-value from an ANCOVA with treatment as factor and baseline as covariate|ANCOVA|||||1.5|-12.3|0.1045
72575042|NCT03149445|144676322|SUPERIORITY||LS Mean Difference|0.7||||0.7422|TWO_SIDED|95.0|-4.0|5.3||P-value from an ANCOVA with treatment as factor and baseline as covariate|ANCOVA|||||5.3|-4.0|0.7422
72575043|NCT03149445|144676322|SUPERIORITY||LS Mean Difference|5.6||||0.046|TWO_SIDED|95.0|0.1|11.0||P-value from an ANCOVA with treatment as factor and baseline as covariate|ANCOVA|||||11.0|0.1|0.0460
72575044|NCT03149445|144676322|SUPERIORITY||LS Mean Difference|4.3||||0.3847|TWO_SIDED|95.0|-9.2|17.8||P-value from an ANCOVA with treatment as factor and baseline as covariate|ANCOVA|||||17.8|-9.2|0.3847
72575045|NCT03149445|144676323|SUPERIORITY||LS Mean Difference|-6.2||||0.1326|TWO_SIDED|95.0|-14.9|2.5||P-value from an ANCOVA with treatment as factor and baseline as covariate|ANCOVA|||||2.5|-14.9|0.1326
72575046|NCT03149445|144676323|SUPERIORITY||LS Mean Difference|1.2||||0.5148|TWO_SIDED|95.0|-2.9|5.3||P-value from an ANCOVA with treatment as factor and baseline as covariate|ANCOVA|||||5.3|-2.9|0.5148
72575047|NCT03149445|144676323|SUPERIORITY||LS Mean Difference|4.5||||0.0605|TWO_SIDED|95.0|-0.3|9.4||P-value from an ANCOVA with treatment as factor and baseline as covariate|ANCOVA|||||9.4|-0.3|0.0605
72575048|NCT03149445|144676323|SUPERIORITY||LS Mean Difference|2.6||||0.5198|TWO_SIDED|95.0|-8.8|14.0||P-value from an ANCOVA with treatment as factor and baseline as covariate|ANCOVA|||||14.0|-8.8|0.5198
72575049|NCT03149445|144676324|SUPERIORITY||LS Mean Difference|-8.1||||0.0058|TWO_SIDED|95.0|-12.5|-3.6||P-value from an ANCOVA with treatment as factor and baseline as covariate|ANCOVA|||||-3.6|-12.5|0.0058
72575050|NCT03149445|144676324|SUPERIORITY||LS Mean Difference|2.1||||0.5142|TWO_SIDED|95.0|-5.3|9.5||P-value from an ANCOVA with treatment as factor and baseline as covariate|ANCOVA|||||9.5|-5.3|0.5142
72575051|NCT03149445|144676324|SUPERIORITY||LS Mean Difference|3.1||||0.3794|TWO_SIDED|95.0|-5.1|11.3||P-value from an ANCOVA with treatment as factor and baseline as covariate|ANCOVA|||||11.3|-5.1|0.3794
72575052|NCT03149445|144676324|SUPERIORITY||LS Mean Difference|1.0||||0.685|TWO_SIDED|95.0|-6.1|8.1||P-value from an ANCOVA with treatment as factor and baseline as covariate|ANCOVA|||||8.1|-6.1|0.6850
72575053|NCT04005352|144676346|SUPERIORITY||||||<|0.0001|ONE_SIDED|||||with significance level of 0.025|Wilcoxon (Mann-Whitney)|||||||<0.0001
72575054|NCT04005352|144676347|NON_INFERIORITY|4 letter margin (1-sided)|Difference|0.1|STANDARD_ERROR_OF_MEAN|0.73|<|0.0001|TWO_SIDED|95.0|-1.3|1.5|||ANOVA|||||1.5|-1.3|<0.0001
72575055|NCT04005352|144676348|SUPERIORITY||||||<|0.0001|ONE_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
72575056|NCT04005352|144676349|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
72575057|NCT04005352|144676350|SUPERIORITY|Week 14|Odds Ratio (OR)|1.6||||0.051|TWO_SIDED|95.0|0.9|2.7|||likelihood ratio test|Assessed at one-sided 0.025 significance level||||2.7|0.9|0.0510
72575058|NCT04005352|144676350|SUPERIORITY|Week 16|Odds Ratio (OR)|2.6|||<|0.0001|TWO_SIDED|95.0|1.7|3.9|||likelihood ratio test|Assessed at one-sided 0.025 significance level||||3.9|1.7|<0.0001
72575059|NCT04005352|144676353|SUPERIORITY||Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.84||0.8137|TWO_SIDED|95.0|-1.9|1.5||p-value for treatment difference|ANOVA|||||1.5|-1.9|0.8137
72575060|NCT04005352|144676354|SUPERIORITY|Week 32|Odds Ratio (OR)|1.0||||0.4106|TWO_SIDED|95.0|0.7|1.3|||likelihood ratio test|adjusting for baseline BCVA categories (\<55, 55-\<73, ≥73 letters).||||1.3|0.7|0.4106
72575061|NCT04005352|144676354|SUPERIORITY|Week 64|Odds Ratio (OR)|1.0||||0.4667|TWO_SIDED|95.0|0.7|1.4|||likelihood ratio test|adjusting for baseline BCVA categories (\<55, 55-\<73, ≥73 letters).||||1.4|0.7|0.4667
72575062|NCT04005352|144676355|SUPERIORITY|Week 32|Odds Ratio (OR)|1.1||||0.2397|TWO_SIDED|95.0|0.8|1.7|||likelihood ratio test|assessed at the 0.025 significance level||||1.7|0.8|0.2397
72575063|NCT04005352|144676355|SUPERIORITY|Week 64|Odds Ratio (OR)|1.2||||0.115|TWO_SIDED|95.0|0.9|1.8|||likelihood ratio test|assessed at the 0.025 significance level||||1.8|0.9|0.1150
72409541|NCT01516879|144327484|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-46.21|STANDARD_ERROR_OF_MEAN|1.82|<|0.001|TWO_SIDED|95.0|-49.79|-42.63|||Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit and the interaction of treatment with scheduled visit as covariates.|Treatment difference using placebo as the reference.|||-42.63|-49.79|<0.001
72409542|NCT01516879|144327485|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-22.35|STANDARD_ERROR_OF_MEAN|1.94|<|0.001|TWO_SIDED|95.0|-26.15|-18.55|||Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit and the interaction of treatment with scheduled visit as covariates.|Treatment difference using placebo as the reference.|||-18.55|-26.15|<0.001
72409543|NCT01516879|144327486|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-11.54|STANDARD_ERROR_OF_MEAN|2.89|<|0.001|TWO_SIDED|95.0|-17.21|-5.86|||Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit and the interaction of treatment with scheduled visit as covariates.|Treatment difference using placebo as the reference.|||-5.86|-17.21|<0.001
72409544|NCT01516879|144327487|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|5.42|STANDARD_ERROR_OF_MEAN|1.09|<|0.001|TWO_SIDED|95.0|3.28|7.56|||Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit and the interaction of treatment with scheduled visit as covariates.|Treatment difference using placebo as the reference.|||7.56|3.28|<0.001
72538510|NCT02032823|144606353|SUPERIORITY||Hazard Ratio (HR)|0.574||||2.57e-05|TWO_SIDED|99.5|0.392|0.831||A multiple testing procedure is employed across the primary and all key secondary endpoints to strongly control overall type I error at 5% (2 sided) accounting for all analysis timepoints.|Log Rank|Log rank test is stratified by chemotherapy type, hormone receptor status, and prior platinum therapy using a pre-specified pooling strategy.|Estimate of the treatment hazard ratio is based on a stratified Cox's Proportional Hazards Model, \<1 indicates a lower risk with olaparib compared with placebo arm. Stratification factors are the same as those used in the stratified log-rank test.|||0.831|0.392|0.0000257
72538511|NCT02032823|144606354|SUPERIORITY||Hazard Ratio (HR)|0.678||||0.0091|TWO_SIDED|98.5|0.468|0.973||A multiple testing procedure is employed across the primary and all key secondary endpoints to strongly control overall type I error at 5% (2 sided) accounting for all analysis timepoints.|Log Rank|Log rank test is stratified by chemotherapy type, hormone receptor status, and prior platinum therapy using a pre-specified pooling strategy.|Estimate of the treatment hazard ratio is based on a stratified Cox's Proportional Hazards Model, \<1 indicates a lower risk with olaparib compared with placebo arm. Stratification factors are the same as those used in the stratified log-rank test.|||0.973|0.468|0.0091
72538512|NCT03428217|144606360|SUPERIORITY||Hazard Ratio (HR)|0.94||||0.6528|TWO_SIDED|95.0|0.74|1.21|||Log Rank|||Stratified Analysis 1: Stratified by prior programmed cell death protein 1/programmed cell death protein ligand 1 (PD-1/PDL1) inhibitor therapy (yes vs no) and International Metastatic Renal Cell Carcinoma Database (IMDC) prognostic risk group (favorable vs intermediate vs poor).||1.21|0.74|0.6528
72538513|NCT03428217|144606360|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.8193|TWO_SIDED|95.0|0.76|1.24|||Log Rank|||Stratified Analysis 2: Stratified by prior PD-1/PD-L1 inhibitor therapy \[yes vs. no\] and IMDC prognostic risk group \[favorable vs. intermediate/poor\].||1.24|0.76|0.8193
72538514|NCT03428217|144606360|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.8345|TWO_SIDED|95.0|0.76|1.25|||Log Rank|||Stratified Analysis 3: Stratified by the number of prior anti-angio cancer therapy \[0 vs. \>=1\].||1.25|0.76|0.8345
72538515|NCT03428217|144606360|SUPERIORITY||Hazard Ratio (HR)|0.99||||0.9479|TWO_SIDED|95.0|0.78|1.27|||Log Rank|||Unstratified Analysis||1.27|0.78|0.9479
72538516|NCT03428217|144606361|SUPERIORITY||Hazard Ratio (HR)|1.15||||0.3867|TWO_SIDED|95.0|0.83|1.6|||Log Rank|||Stratified Analysis 1: Stratified by prior PD-1/PD-L1 inhibitor therapy \[yes vs. no\] and IMDC prognostic risk group \[favorable vs. intermediate vs. poor\].||1.6|0.83|0.3867
72538517|NCT03428217|144606361|SUPERIORITY||Hazard Ratio (HR)|1.17||||0.3367|TWO_SIDED|95.0|0.85|1.62|||Log Rank|||Stratified Analysis 2: Stratified by prior PD-1/PD-L1 inhibitor therapy \[yes vs. no\] and IMDC prognostic risk group \[favorable vs. intermediate/poor\].||1.62|0.85|0.3367
72538518|NCT03428217|144606361|SUPERIORITY||Hazard Ratio (HR)|1.22||||0.2416|TWO_SIDED|95.0|0.88|1.69|||Log Rank|||Stratified Analysis 3: Stratified by prior PD-1/PD-L1 inhibitor therapy \[yes vs. no\] and IMDC prognostic risk group \[favorable vs. intermediate/poor\].||1.69|0.88|0.2416
72538519|NCT03428217|144606361|SUPERIORITY||Hazard Ratio (HR)|1.19||||0.3043|TWO_SIDED|95.0|0.86|1.64|||Log Rank|||Unstratified Analysis||1.64|0.86|0.3043
72409545|NCT01516879|144327488|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-29.15|STANDARD_ERROR_OF_MEAN|5.64|<|0.001|TWO_SIDED|95.0|-40.23|-18.08|||Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit and the interaction of treatment with scheduled visit as covariates.|Treatment difference using placebo as the reference.|||-18.08|-40.23|<0.001
72409546|NCT01516879|144327489|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-0.14|STANDARD_ERROR_OF_MEAN|1.84||0.94|TWO_SIDED|95.0|-3.76|3.48|||ANCOVA|The ANCOVA model includes treatment group and stratification factor as covariates.|Treatment difference using placebo as the reference.|||3.48|-3.76|0.94
72409547|NCT01720069|144327492|SUPERIORITY|||||||0.772|||||||ANCOVA|||||||0.772
72409548|NCT01720069|144327493|SUPERIORITY|||||||0.891|||||||ANCOVA|||||||0.891
72409549|NCT01720069|144327494|SUPERIORITY|||||||0.066|||||||ANCOVA|||||||0.066
72409550|NCT01720069|144327495|SUPERIORITY|||||||0.063|||||||ANCOVA|||||||0.063
72409551|NCT01720069|144327496|SUPERIORITY|||||||0.054|||||||ANCOVA|||||||0.054
72409552|NCT01720069|144327497|SUPERIORITY|||||||0.168|||||||Fisher Exact|||||||0.168
72409553|NCT01720069|144327497|SUPERIORITY|||||||0.363|||||||Fisher Exact|||||||0.363
72409554|NCT01720069|144327497|SUPERIORITY|||||||0.805|||||||Fisher Exact|||||||0.805
72409555|NCT00508742|144327499|SUPERIORITY_OR_OTHER||Rate Ratio|0.56|||||TWO_SIDED|95.0|0.47|0.65||||||||0.65|0.47|
72409556|NCT00508742|144327500|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.6|||||TWO_SIDED|95.0|0.5|0.9||||||Month 7: 13vPnC/7vPnC, odds ratio was calculated using a logistic regression model with treatment group as the independent variable.||0.9|0.5|
72409557|NCT00508742|144327500|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.6|||||TWO_SIDED|95.0|0.4|0.7||||||Month 12: 13vPnC/7vPnC, odds ratio was calculated using a logistic regression model with treatment group as the independent variable.||0.7|0.4|
72409558|NCT00508742|144327500|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.4|||||TWO_SIDED|95.0|0.3|0.5||||||Month 13: 13vPnC/7vPnC, odds ratio was calculated using a logistic regression model with treatment group as the independent variable.||0.5|0.3|
72409559|NCT00508742|144327500|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.5|||||TWO_SIDED|95.0|0.4|0.7||||||Month 18: 13vPnC/7vPnC, odds ratio was calculated using a logistic regression model with treatment group as the independent variable.||0.7|0.4|
72409560|NCT00508742|144327500|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.5|||||TWO_SIDED|95.0|0.4|0.8||||||Month 24: 13vPnC/7vPnC, odds ratio was calculated using a logistic regression model with treatment group as the independent variable.||0.8|0.4|
72538520|NCT03428217|144606362|SUPERIORITY||Hazard Ratio (HR)|1.0||||0.9692|TWO_SIDED|95.0|0.79|1.25|||Log Rank|||Stratified Analysis 1: Stratified by prior PD-1/PD-L1 inhibitor therapy \[yes vs. no\] and IMDC prognostic risk group \[favorable vs. intermediate vs. poor\].||1.25|0.79|0.9692
72538521|NCT03428217|144606362|SUPERIORITY||Hazard Ratio (HR)|1.01||||0.9235|TWO_SIDED|95.0|0.8|1.27|||Log Rank|||Stratified Analysis 2: Stratified by prior PD-1/PD-L1 inhibitor therapy \[yes vs. no\] and IMDC prognostic risk group \[favorable vs. intermediate/poor\].||1.27|0.8|0.9235
72538522|NCT03428217|144606362|SUPERIORITY||Hazard Ratio (HR)|1.01||||0.9549|TWO_SIDED|95.0|0.8|1.26|||Log Rank|||Stratified Analysis 3: Stratified by the number of prior anti-angio cancer therapy \[0 vs. \>=1\].||1.26|0.8|0.9549
72538523|NCT03428217|144606362|SUPERIORITY||Hazard Ratio (HR)|1.03||||0.8193|TWO_SIDED|95.0|0.82|1.29|||Log Rank|||Unstratified Analysis||1.29|0.82|0.8193
72538524|NCT03889197|144606363|SUPERIORITY|||||||0.162|||||||Kruskal-Wallis|||||||0.162
72538525|NCT03889197|144606364|SUPERIORITY|||||||0.242|||||||Kruskal-Wallis|||||||0.242
72538526|NCT03889197|144606365|SUPERIORITY|||||||0.956|||||||Kruskal-Wallis|||||||0.956
72538527|NCT03889197|144606366|SUPERIORITY|||||||0.132|||||||Kruskal-Wallis|||||||0.132
72538528|NCT03889197|144606367|SUPERIORITY|||||||0.445|||||||Kruskal-Wallis|||||||0.445
72538529|NCT03889197|144606368|SUPERIORITY|||||||0.746|||||||Kruskal-Wallis|||||||0.746
72538530|NCT03889197|144606369|SUPERIORITY|||||||0.979|||||||Kruskal-Wallis|||||||0.979
72538531|NCT03889197|144606370|SUPERIORITY|||||||0.289|||||||Chi-squared|||||||0.289
72409561|NCT03246529|144327518|SUPERIORITY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|Stratified Cochran-Mantel-Haenszel (CMH) test (by response status and baseline platelet count),||||||<0.0001
72409562|NCT03246529|144327519|SUPERIORITY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
72409563|NCT03246529|144327520|SUPERIORITY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
72409564|NCT03117387|144327558|OTHER|Bland-Altman analysis estimates bias between TOF-Cuff and electromyography.|bias|0.0|||||TWO_SIDED|0.05|-0.05|0.05||||||"Paired measurements were compared using a Bland-Altman analysis modified for repeated measurements (http://sec.lumc.nl/method\_agreement\_analysis, Leiden, the Netherlands).~This Bland-Altman analysis corrects for between subject variability of repeated paired measurements in individual subjects."||0.05|-0.05|
72409565|NCT06748040|144327579|SUPERIORITY||Mean Difference (Final Values)|-0.6||||0.4852|TWO_SIDED|95.0|-2.4|1.2||P-value less than 0.05 is considered as statistically significant.|t-test, 2 sided|||||1.2|-2.4|0.4852
72409566|NCT00320281|144327581|SUPERIORITY_OR_OTHER_LEGACY|||||||0.432||95.0|||||ANCOVA|||||||0.432
72409567|NCT01856140|144327583|OTHER|||||||0.52|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: There is no difference between the two groups at baseline||||0.52
72409568|NCT01856140|144327583|OTHER|||||||0.47|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: There is no difference between the two groups at post-injection 6 weeks.||||0.47
72409569|NCT01856140|144327583|OTHER|||||||0.52|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: There is no difference between the two groups at post-injection 12 weeks.||||0.52
72409570|NCT01856140|144327584|OTHER|||||||0.227|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: There is no difference between the two groups at baseline||||0.227
72409571|NCT01856140|144327584|OTHER|||||||0.573|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: There is no difference between the two groups at post-injection 6 weeks.||||0.573
72538532|NCT03889197|144606371|SUPERIORITY|||||||0.94|||||||Kruskal-Wallis|||||||0.940
72538533|NCT03889197|144606372|SUPERIORITY|||||||0.126|||||||Chi-squared|||||||0.126
72538534|NCT03889197|144606373|SUPERIORITY|||||||0.738|||||||Fisher Exact|||||||0.738
72409572|NCT01856140|144327584|OTHER|||||||0.588|||||||Wilcoxon (Mann-Whitney)|||||||0.588
72409573|NCT01856140|144327585|OTHER|||||||0.262|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: There is no difference between the two groups at baseline||||0.262
72409574|NCT01856140|144327585|OTHER|||||||0.631|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: There is no difference between the two groups at post-injection 6 weeks.||||0.631
72538535|NCT03889197|144606374|SUPERIORITY|||||||0.676|||||||Fisher Exact|||||||0.676
72538536|NCT03889197|144606375|SUPERIORITY|||||||0.996|||||||Kruskal-Wallis|||||||0.996
72538537|NCT03889197|144606376|SUPERIORITY|||||||0.095|||||||Kruskal-Wallis|||||||0.095
72538538|NCT03078192|144606428|OTHER|Detecting pre-capillary PH was tested with a cohort of 32 patients. True PH status was based on RHC. A diagnosis of PH was established from mPAP \>20mmHg, while pre-capillary PH required PCWP ≤ 15mmHg and PVR ≥ 3 Woods Units, and post capillary PH required PCWP \> 15mmH and PVR \< 3 Woods Units \[21\]. Patients with both high PVR and PCWP \> 15mmHg were classified as combined pre- and post-capillary PH (CpcPH). Subjects with CpcPH were treated as positive for both pre- and post-capillary PH.|positive predictive value|0.86|||||TWO_SIDED|||||Positive predictive value for Precapillary Pulmonary Hypertension: 86%|calculation of PPV|||||||
72538539|NCT01186744|144606432|SUPERIORITY_OR_OTHER|||||||0.0008|TWO_SIDED||||||Log Rank|||||||0.0008
72538540|NCT01186744|144606432|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Log Rank|||||||<0.0001
72538541|NCT01186744|144606433|SUPERIORITY_OR_OTHER|||||||0.0027|TWO_SIDED||||||Log Rank|||||||0.0027
72538542|NCT01186744|144606433|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Log Rank|||||||<0.0001
72538543|NCT02547779|144606557|SUPERIORITY||Odds Ratio (OR)|0.95|||<|0.05|TWO_SIDED||||||Regression, Logistic|||||||<0.05
72538544|NCT02547779|144606558|SUPERIORITY||Odds Ratio (OR)|0.98|||<|0.05|TWO_SIDED||||||Regression, Logistic|||||||<0.05
72538545|NCT01020773|144606559|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||ANOVA|||||||>0.05
72538546|NCT01389024|144606560|SUPERIORITY||Incidence rate ratio|0.216||||0.2914|TWO_SIDED|90.0|0.009|1.66|||Poisson Regression||We calculated confidence intervals from exact Poisson regression.|||1.66|.009|0.2914
72409575|NCT01856140|144327585|OTHER|||||||0.796|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: There is no difference between the two groups at post-injection 12 weeks.||||0.796
72409576|NCT01856140|144327586|OTHER|||||||0.337|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: There is no difference between the two groups at baseline||||0.337
72409577|NCT01856140|144327586|OTHER|||||||0.078|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: There is no difference between the two groups at post-injection 6 weeks||||0.078
72409578|NCT01856140|144327586|OTHER|||||||0.439|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: There is no difference between the two groups at post-injection 12 weeks.||||0.439
72409579|NCT00827372|144327587|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0658|||||||t-test, 2 sided|||With a sample size of 14 evaluable subjects, we will have 80% power to detect a change in excess arm volume of .8 standard deviations using a two-sided paired t-test. We will have 90% power to detect a difference of .9 standard deviations. A Paired T-Test was used to test the difference in arm volume from the second baseline measurement to Cycle 2 only.||||0.0658
72538547|NCT00819091|144606564|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.47|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001||95.0|-0.7|-0.24|||ANCOVA|ANCOVA model includes treatment and number of prior oral anti-diabetic drug as fixed classification effects and baseline HbA1c as a linear covariate||Linagliptin 5.0 mg versus placebo||-0.24|-0.70|< 0.0001
72538548|NCT00819091|144606565|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-6.4|STANDARD_ERROR_OF_MEAN|5.5||0.2406||95.0|-17.2|4.3|||ANCOVA|ANCOVA model includes treatment and number of prior oral anti-diabetic drug as fixed classification effects and baseline HbA1c as a linear covariate||Linagliptin 5.0 mg versus placebo||4.3|-17.2|0.2406
72575064|NCT04005352|144676356|SUPERIORITY|Weeks 28 and 32|Difference|-26.9|STANDARD_ERROR_OF_MEAN|9.87||0.0066|TWO_SIDED|95.0|-46.3|-7.5|||ANOVA|||||-7.5|-46.3|0.0066
72409580|NCT00827372|144327588|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0061|||||||t-test, 2 sided|||A Paired T-Test was used to compare the IFP affected at first versus affected at last reading.||||0.0061
72409581|NCT00827372|144327589|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0143|||||||t-test, 2 sided|||A Paired T-Test was used for the difference in the impedance ratio from the second baseline to cycle 2, day 1||||0.0143
72409582|NCT02139644|144327596|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|0.154||||0.0076|TWO_SIDED|95.0|0.041|0.267|||ANCOVA|Fixed effects of treatment, sex, (pooled) center, previous therapy (ICS or ICS/LABA), and covariates of age and baseline FEV1.||A fixed-sequence multiple testing procedure was used to control the overall Type I error rate at the 0.05 level (2-sided) for the primary endpoints analyses. Analyses appear in the defined sequence. This is the first in the sequence.||0.267|0.041|0.0076
72409583|NCT02139644|144327596|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|0.131||||0.0322|TWO_SIDED|95.0|0.011|0.25|||ANCOVA|Fixed effects of treatment, sex, (pooled) center, previous therapy (ICS or ICS/LABA), and covariates of age and baseline FEV1.||A fixed-sequence multiple testing procedure was used to control the overall Type I error rate at the 0.05 level (2-sided) for the primary endpoints analyses. Analyses appear in the defined sequence. This is the second in the sequence.||0.250|0.011|0.0322
72409584|NCT02139644|144327596|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|0.335||||0|TWO_SIDED|95.0|0.216|0.453|||ANCOVA|Fixed effects of treatment, sex, (pooled) center, previous therapy (ICS or ICS/LABA), and covariates of age and baseline FEV1.||A fixed-sequence multiple testing procedure was used to control the overall Type I error rate at the 0.05 level (2-sided) for the primary endpoints analyses. Analyses appear in the defined sequence. This is the third in the sequence.||0.453|0.216|0.0000
72409585|NCT02139644|144327596|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|0.325||||0|TWO_SIDED|95.0|0.203|0.447|||ANCOVA|Fixed effects of treatment, sex, (pooled) center, previous therapy (ICS or ICS/LABA), and covariates of age and baseline FEV1.||A fixed-sequence multiple testing procedure was used to control the overall Type I error rate at the 0.05 level (2-sided) for the primary endpoints analyses. Analyses appear in the defined sequence. This is the fourth in the sequence.||0.447|0.203|0.0000
72409586|NCT02139644|144327597|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|0.262||||0|TWO_SIDED|95.0|0.168|0.356|||ANCOVA|Effects due to baseline trough AM FEV1, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), and treatment.||A fixed-sequence multiple testing procedure was used to control the overall Type I error rate at the 0.05 level (2-sided) for the primary endpoints analyses. Analyses appear in the defined sequence. This is the fifth in the sequence.||0.356|0.168|0.0000
72409587|NCT02139644|144327597|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|0.266||||0|TWO_SIDED|95.0|0.172|0.36|||ANCOVA|Effects due to baseline trough AM FEV1, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), and treatment.||A fixed-sequence multiple testing procedure was used to control the overall Type I error rate at the 0.05 level (2-sided) for the primary endpoints analyses. Analyses appear in the defined sequence. This is the sixth in the sequence.||0.360|0.172|0.0000
72409588|NCT02139644|144327597|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|0.151||||0.0017|TWO_SIDED|95.0|0.057|0.244|||ANCOVA|Effects due to baseline trough AM FEV1, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), and treatment.||A fixed-sequence multiple testing procedure was used to control the overall Type I error rate at the 0.05 level (2-sided) for the primary endpoints analyses. Analyses appear in the defined sequence. This is the seventh in the sequence.||0.244|0.057|0.0017
72538549|NCT00819091|144606566|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.466||||0.0065||95.0|1.684|24.825|||Regression, Logistic|||Linagliptin 5.0 mg versus placebo||24.825|1.684|0.0065
72538550|NCT00819091|144606567|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.653||||0.2431||95.0|0.515|13.652|||Regression, Logistic|||Linagliptin 5.0 mg versus placebo||13.652|0.515|0.2431
72575065|NCT04005352|144676356|SUPERIORITY|Weeks 60 and 64|Difference|-15.4|STANDARD_ERROR_OF_MEAN|11.26||0.1714|TWO_SIDED|95.0|-37.6|6.7|||ANOVA|||||6.7|-37.6|0.1714
72575066|NCT04005352|144676359|SUPERIORITY|Week 32|LS Mean Difference|0.37||||0.193|TWO_SIDED|95.0|-0.2|0.9|||ANCOVA|||||0.9|-0.2|0.193
72575067|NCT04005352|144676359|SUPERIORITY|Week 64|LS Mean Difference|-2.0||||0.052|TWO_SIDED|95.0|-3.9|0.0|||ANCOVA|||||0.0|-3.9|0.052
72575068|NCT04005352|144676360|SUPERIORITY|Week 32|LS Mean Difference|2.16||||0.081|TWO_SIDED|95.0|-0.3|4.6|||ANCOVA|||||4.6|-0.3|0.081
72409589|NCT02139644|144327597|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|0.119||||0.0132|TWO_SIDED|95.0|0.025|0.212|||ANCOVA|Effects due to baseline trough AM FEV1, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), and treatment.||A fixed-sequence multiple testing procedure was used to control the overall Type I error rate at the 0.05 level (2-sided) for the primary endpoints analyses. Analyses appear in the defined sequence. This is the eighth in the sequence.||0.212|0.025|0.0132
72409590|NCT02139644|144327598|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|10.926||||0.0123|TWO_SIDED|95.0|2.38|19.471||Significance level of 0.05.|mixed model for repeated measures|||The analysis of change from baseline in weekly average of daily (AM predose and pre-rescue bronchodilator) PEF over the 12-week treatment period was performed using an mixed model for repeated measures (MMRM) with an unstructured covariance matrix and with effects due to baseline weekly average of daily AM PEF, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), week, treatment, and week-by-treatment interaction.||19.471|2.380|0.0123
72409591|NCT02139644|144327598|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|7.018||||0.1074|TWO_SIDED|95.0|-1.531|15.567||Significance level of 0.05.|mixed model for repeated measures|||The analysis of change from baseline in weekly average of daily (AM predose and pre-rescue bronchodilator) PEF over the 12-week treatment period was performed using an mixed model for repeated measures (MMRM) with an unstructured covariance matrix and with effects due to baseline weekly average of daily AM PEF, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), week, treatment, and week-by-treatment interaction.||15.567|-1.531|0.1074
72409592|NCT02139644|144327598|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|20.824||||0|TWO_SIDED|95.0|12.253|29.395||Significance level of 0.05.|mixed model for repeated measures|||The analysis of change from baseline in weekly average of daily (AM predose and pre-rescue bronchodilator) PEF over the 12-week treatment period was performed using an mixed model for repeated measures (MMRM) with an unstructured covariance matrix and with effects due to baseline weekly average of daily AM PEF, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), week, treatment, and week-by-treatment interaction.||29.395|12.253|0.0000
72409593|NCT02139644|144327598|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|21.273||||0|TWO_SIDED|95.0|12.728|29.818||Significance level of 0.05.|mixed model for repeated measures|||The analysis of change from baseline in weekly average of daily (AM predose and pre-rescue bronchodilator) PEF over the 12-week treatment period was performed using an mixed model for repeated measures (MMRM) with an unstructured covariance matrix and with effects due to baseline weekly average of daily AM PEF, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), week, treatment, and week-by-treatment interaction.||29.818|12.728|0.0000
72409594|NCT02139644|144327598|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|9.898||||0.0233|TWO_SIDED|95.0|1.349|18.447||Significance level of 0.05.|mixed model for repeated measures|||The analysis of change from baseline in weekly average of daily (AM predose and pre-rescue bronchodilator) PEF over the 12-week treatment period was performed using an mixed model for repeated measures (MMRM) with an unstructured covariance matrix and with effects due to baseline weekly average of daily AM PEF, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), week, treatment, and week-by-treatment interaction.||18.447|1.349|0.0233
72409595|NCT02139644|144327598|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|14.255||||0.0011|TWO_SIDED|95.0|5.732|22.778||Significance level of 0.05.|mixed model for repeated measures|||The analysis of change from baseline in weekly average of daily (AM predose and pre-rescue bronchodilator) PEF over the 12-week treatment period was performed using an mixed model for repeated measures (MMRM) with an unstructured covariance matrix and with effects due to baseline weekly average of daily AM PEF, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), week, treatment, and week-by-treatment interaction.||22.778|5.732|0.0011
72409596|NCT02139644|144327598|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|10.347||||0.0175|TWO_SIDED|95.0|1.822|18.872||Significance level of 0.05.|mixed model for repeated measures|||The analysis of change from baseline in weekly average of daily (AM predose and pre-rescue bronchodilator) PEF over the 12-week treatment period was performed using an mixed model for repeated measures (MMRM) with an unstructured covariance matrix and with effects due to baseline weekly average of daily AM PEF, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), week, treatment, and week-by-treatment interaction.||18.872|1.822|0.0175
72538551|NCT00819091|144606568|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.125||||0.0001||95.0|2.747|9.562|||Regression, Logistic|||Linagliptin 5.0 mg versus placebo||9.562|2.747|0.0001
72538552|NCT00819091|144606569|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.41|||<|0.0001||95.0|-0.585|-0.23|||Mixed Models Analysis|MMRM with treatment, number oral anti-diabetic drugs, week within patients, week-treatment interaction and baseline HbA1c as a linear covariate.||Linagliptin 5.0 mg versus placebo||-0.230|-0.585|<0.0001
72575069|NCT04005352|144676360|SUPERIORITY|Week 64|LS Mean Difference|-0.7||||0.59|TWO_SIDED|95.0|-3.2|1.8|||ANCOVA|||||1.8|-3.2|0.590
72538553|NCT00819091|144606570|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.5|||<|0.0001||95.0|-0.72|-0.276|||Mixed Models Analysis|MMRM with treatment, number oral anti-diabetic drugs, week within patients, week-treatment interaction and baseline HbA1c as a linear covariate.||Linagliptin 5.0 mg versus placebo||-0.276|-0.720|<0.0001
72538554|NCT00819091|144606571|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.47||||0.0002||95.0|-0.716|-0.226|||Mixed Models Analysis|MMRM with treatment, number oral anti-diabetic drugs, week within patients, week-treatment interaction and baseline HbA1c as a linear covariate.||Linagliptin 5.0 mg versus placebo||-0.226|-0.716|0.0002
72538555|NCT00819091|144606572|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-5.9|STANDARD_ERROR_OF_MEAN|4.6||0.197||95.0|-14.9|3.1|||ANCOVA|ANCOVA model includes treatment and number of prior oral anti-diabetic drug as fixed classification effects and baseline HbA1c as a linear covariate||Linagliptin 5.0 mg versus placebo||3.1|-14.9|0.197
72575070|NCT04005352|144676361|SUPERIORITY|Week 32|LS Mean Difference|0.77||||0.558|TWO_SIDED|95.0|-1.8|3.4|||ANCOVA|||||3.4|-1.8|0.558
72575071|NCT04005352|144676361|SUPERIORITY|Week 64|LS Mean Difference|-1.9||||0.138|TWO_SIDED|95.0|-4.5|0.6|||ANCOVA|||||0.6|-4.5|0.138
72575072|NCT04005352|144676362|SUPERIORITY|Week 32|LS Mean Difference|1.6||||0.287|TWO_SIDED|95.0|-1.4|4.6|||ANCOVA|||||4.6|-1.4|0.287
72575073|NCT04005352|144676362|SUPERIORITY|Week 64|LS Mean Difference|-3.0||||0.07|TWO_SIDED|95.0|-6.2|0.2|||ANCOVA|||||0.2|-6.2|0.070
72409597|NCT02139644|144327599|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|-0.165||||0.0002|TWO_SIDED|95.0|-0.251|-0.08||Significance level of 0.05.|mixed model for repeated measures|||The change from baseline in the weekly average of the total daily asthma symptom scores over weeks 1 to 12 was analyzed using an MMRM with an unstructured covariance matrix and with effects due to baseline score, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), week, treatment, and week-by-treatment interaction.||-0.080|-0.251|0.0002
72538556|NCT00819091|144606573|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-14.5|STANDARD_ERROR_OF_MEAN|5.6||0.0105||95.0|-25.5|-3.4|||ANCOVA|ANCOVA model includes treatment and number of prior oral anti-diabetic drug as fixed classification effects and baseline HbA1c as a linear covariate||Linagliptin 5.0 mg versus placebo||-3.4|-25.5|0.0105
72575074|NCT04005352|144676363|SUPERIORITY|Week 32|LS Mean Difference|-0.71||||0.602|TWO_SIDED|95.0|-3.4|2.0|||ANCOVA|||||2.0|-3.4|0.602
72575075|NCT04005352|144676363|SUPERIORITY|Week 64|LS Mean Difference|-2.5||||0.086|TWO_SIDED|95.0|-5.3|0.4|||ANCOVA|||||0.4|-5.3|0.086
72538557|NCT00367679|144606574|SUPERIORITY_OR_OTHER||Percentage of participants with response|5.7||||||95.0|0.7|19.2|||||The estimated value given is the percentage of participants who had a response out of the total participants.|||19.2|0.7|
72538558|NCT00367679|144606575|SUPERIORITY_OR_OTHER||Percentage of participants with response|8.6||||||95.0|1.8|23.1|||||The estimated value given is the percentage of participants who had a response out of the total participants.|||23.1|1.8|
72538559|NCT00367679|144606581|SUPERIORITY_OR_OTHER|||||||0.0028||95.0||||VEGF D|t-test, 2 sided|Post- versus pretreatment expression levels for each of the indicated genes in response to pazopanib treatment||||||0.0028
72538560|NCT00367679|144606581|SUPERIORITY_OR_OTHER|||||||0.0324||95.0||||VEGF A|t-test, 2 sided|Post- versus pretreatment expression levels for each of the indicated genes in response to pazopanib treatment||||||0.0324
72538561|NCT00367679|144606581|SUPERIORITY_OR_OTHER|||||||0.0082||95.0||||VEGFR-2|t-test, 2 sided|Post- versus pretreatment expression levels for each of the indicated genes in response to pazopanib treatment||||||0.0082
72538562|NCT00367679|144606581|SUPERIORITY_OR_OTHER|||||||0.0082||95.0||||c-KIT|t-test, 2 sided|Post- versus pretreatment expression levels for each of the indicated genes in response to pazopanib treatment||||||0.0082
72538563|NCT00367679|144606587|SUPERIORITY_OR_OTHER||||||<|0.01||95.0||||Vascular endothelial growth factor receptor 2 (VEGFR2)|Wilcoxon (Mann-Whitney)|Post- versus pretreatment change in levels of cytokines and angiogenic factors in response to pazopanib treatment||||||<0.01
72538564|NCT00367679|144606587|SUPERIORITY_OR_OTHER||||||<|0.01||95.0||||Placental growth factor (PIGF)|Wilcoxon (Mann-Whitney)|Post- versus pretreatment change in levels of cytokines and angiogenic factors in response to pazopanib treatment||||||<0.01
72538565|NCT00367679|144606587|SUPERIORITY_OR_OTHER|||||||0.00024||95.0||||Interferon-inducible cytokine (IP-10)|Wilcoxon (Mann-Whitney)|Post- versus pretreatment change in levels of cytokines and angiogenic factors in response to pazopanib treatment||||||0.00024
72538566|NCT00367679|144606587|SUPERIORITY_OR_OTHER|||||||0.0029||95.0||||Cutaneous T-cell attracting chemokine (CTACK)|Wilcoxon (Mann-Whitney)|Post- versus pretreatment change in levels of cytokines and angiogenic factors in response to pazopanib treatment||||||0.0029
72538567|NCT00367679|144606587|SUPERIORITY_OR_OTHER|||||||0.0062||95.0||||Stromal cell-derived factor 1 (SDF-1alpha)|Wilcoxon (Mann-Whitney)|Post- versus pretreatment change in levels of cytokines and angiogenic factors in response to pazopanib treatment||||||0.0062
72538568|NCT00367679|144606587|SUPERIORITY_OR_OTHER|||||||0.0069||95.0||||Monokine induced by interferon gamma (MIG)|Wilcoxon (Mann-Whitney)|Post- versus pretreatment change in levels of cytokines and angiogenic factors in response to pazopanib treatment||||||0.0069
72538569|NCT00367679|144606587|SUPERIORITY_OR_OTHER|||||||0.0093||95.0||||Tumor necrosis factor ligand (TRAIL)|Wilcoxon (Mann-Whitney)|Post- versus pretreatment change in levels of cytokines and angiogenic factors in response to pazopanib treatment||||||0.0093
72538570|NCT00367679|144606587|SUPERIORITY_OR_OTHER|||||||0.021||95.0||||Interferon alpha 2 (IFN-alpha2)|Wilcoxon (Mann-Whitney)|Post- versus pretreatment change in levels of cytokines and angiogenic factors in response to pazopanib treatment||||||0.021
72538571|NCT00367679|144606587|SUPERIORITY_OR_OTHER|||||||0.326||95.0||||Vascular endothelial growth factor (VEGF)|Wilcoxon (Mann-Whitney)|Post- versus pretreatment change in levels of cytokines and angiogenic factors in response to pazopanib treatment||||||0.326
72538572|NCT02675426|144606588|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure.|Response Rate Difference|28.1|||<|0.001|TWO_SIDED|95.0|19.1|37.0||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification factor of prior biological disease-modifying anti-rheumatoid drug use.|Response Rate Difference = Upadacitinib - Placebo|||37.0|19.1|<0.001
72538573|NCT02675426|144606588|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure.|Response Rate Difference|30.5|||<|0.001|TWO_SIDED|95.0|21.6|39.4||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification factor of prior biological disease-modifying anti-rheumatoid drug use.|Response Rate Difference = Upadacitinib - Placebo|||39.4|21.6|<0.001
72575076|NCT04005352|144676364|SUPERIORITY|Week 32|LS Mean Difference|1.55||||0.174|TWO_SIDED|95.0|-0.7|3.8|||ANCOVA|||||3.8|-0.7|0.174
72575077|NCT04005352|144676364|SUPERIORITY|Week 64|LS Mean Difference|-1.5||||0.21|TWO_SIDED|95.0|-3.8|0.8|||ANCOVA|||||0.8|-3.8|0.210
72575078|NCT04005352|144676365|SUPERIORITY|Week 32|LS Mean Difference|-0.96||||0.499|TWO_SIDED|95.0|-3.8|1.8|||ANCOVA|||||1.8|-3.8|0.499
72575079|NCT04005352|144676365|SUPERIORITY|Week 64|LS Mean Difference|-2.3||||0.147|TWO_SIDED|95.0|-5.4|0.8|||ANCOVA|||||0.8|-5.4|0.147
72575080|NCT04005352|144676366|SUPERIORITY|Week 32|LS Mean Difference|0.88||||0.643|TWO_SIDED|95.0|-2.8|4.6|||ANCOVA|||||4.6|-2.8|0.643
72575081|NCT04005352|144676366|SUPERIORITY|Week 64|LS Mean Difference|-1.3||||0.507|TWO_SIDED|95.0|-5.0|2.5|||ANCOVA|||||2.5|-5.0|0.507
72575082|NCT04005352|144676367|SUPERIORITY|Week 32|LS Mean Difference|0.49||||0.7|TWO_SIDED|95.0|-2.0|3.0|||ANCOVA|||||3.0|-2.0|0.700
72575083|NCT04005352|144676367|SUPERIORITY|Week 64|LS Mean Difference|-2.9||||0.07|TWO_SIDED|95.0|-6.0|0.2|||ANCOVA|||||0.2|-6.0|0.070
72538574|NCT02675426|144606589|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure.|Response Rate Difference|31.2|||<|0.001|TWO_SIDED|95.0|23.0|39.5||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification factor of prior biological disease-modifying anti-rheumatoid drug use.|Response Rate Difference = Upadacitinib - Placebo|||39.5|23.0|<0.001
72538575|NCT02675426|144606589|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure.|Response Rate Difference|30.8|||<|0.001|TWO_SIDED|95.0|22.5|39.0||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification factor of prior biological disease-modifying anti-rheumatoid drug use.|Response Rate Difference = Upadacitinib - Placebo|||39.0|22.5|<0.001
72538576|NCT02675426|144606590|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure.|Least Squares (LS) Mean Difference|-1.18|||<|0.001|TWO_SIDED|95.0|-1.42|-0.94||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|ANCOVA|Analysis of covariance (ANCOVA) model with treatment, prior bDMARD use and Baseline value as covariates.|Treatment Difference = Upadacitinib - Placebo|||-0.94|-1.42|<0.001
72538577|NCT02675426|144606590|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure.|LS Mean Difference|-1.32|||<|0.001|TWO_SIDED|95.0|-1.56|-1.08||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|ANCOVA|ANCOVA model with treatment, prior bDMARD use and Baseline value as covariates.|Treatment Difference = Upadacitinib - Placebo|||-1.08|-1.56|<0.001
72538578|NCT02675426|144606591|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure.|LS Mean Difference|-0.33|||<|0.001|TWO_SIDED|95.0|-0.43|-0.24||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|ANCOVA|ANCOVA model with treatment, prior bDMARD use and Baseline value as covariates.|Treatment Difference = Upadacitinib - Placebo|||-0.24|-0.43|<0.001
72538579|NCT02675426|144606591|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure.|LS Mean Difference|-0.28|||<|0.001|TWO_SIDED|95.0|-0.38|-0.18||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|ANCOVA|ANCOVA model with treatment, prior bDMARD use and Baseline value as covariates.|Treatment Difference = Upadacitinib - Placebo|||-0.18|-0.38|<0.001
72538580|NCT02675426|144606592|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure.|LS Mean Difference|4.55|||<|0.001|TWO_SIDED|95.0|3.13|5.98||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|Mixed Effect Model Repeat Measurement|MMRM model with fixed effects of treatment, visit, and treatment-by-visit interaction, previous bDMARD use, and Baseline value as covariate.|Treatment Difference = Upadacitinib - Placebo|||5.98|3.13|<0.001
72538581|NCT02675426|144606592|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure.|LS Mean Difference|4.98|||<|0.001|TWO_SIDED|95.0|3.54|6.42||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|Mixed Effect Model Repeat Measurement|MMRM model with fixed effects of treatment, visit, and treatment-by-visit interaction, previous bDMARD use, and Baseline value as covariate.|Treatment Difference = Upadacitinib - Placebo|||6.42|3.54|<0.001
72538582|NCT02675426|144606593|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure.|Response Rate Difference|20.8|||<|0.001|TWO_SIDED|95.0|13.6|28.1||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification factor of prior biological disease-modifying anti-rheumatoid drug use.|Response Rate Difference = Upadacitinib - Placebo|||28.1|13.6|<0.001
72538583|NCT02675426|144606593|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure.|Response Rate Difference|18.4|||<|0.001|TWO_SIDED|95.0|11.2|25.5||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification factor of prior biological disease-modifying anti-rheumatoid drug use.|Response Rate Difference = Upadacitinib - Placebo|||25.5|11.2|<0.001
72538584|NCT02675426|144606594|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure.|Response Rate Difference|21.3|||<|0.001|TWO_SIDED|95.0|13.0|29.5||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification factor of prior biological disease-modifying anti-rheumatoid drug use.|Response Rate Difference = Upadacitinib - Placebo|||29.5|13.0|<0.001
72538585|NCT02675426|144606594|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure.|Response Rate Difference|23.0|||<|0.001|TWO_SIDED|95.0|14.7|31.3||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification factor of prior biological disease-modifying anti-rheumatoid drug use.|Response Rate Difference = Upadacitinib - Placebo|||31.3|14.7|<0.001
72575084|NCT04005352|144676368|SUPERIORITY|Week 32|LS Mean Difference|0.73||||0.741|TWO_SIDED|95.0|-3.6|5.1|||ANCOVA|||||5.1|-3.6|0.741
72575085|NCT04005352|144676368|SUPERIORITY|Week 64|LS Mean Difference|-1.7||||0.494|TWO_SIDED|95.0|-6.6|3.2|||ANCOVA|||||3.2|-6.6|0.494
72575086|NCT04005352|144676369|SUPERIORITY|Week 32|LS Mean Difference|1.76||||0.054|TWO_SIDED|95.0|0.0|3.5|||ANCOVA|||||3.5|-0.0|0.054
72575087|NCT04005352|144676369|SUPERIORITY|Week 64|LS Mean Difference|-1.1||||0.331|TWO_SIDED|95.0|-3.4|1.2|||ANCOVA|||||1.2|-3.4|0.331
72575088|NCT04005352|144676370|SUPERIORITY|Week 32|LS Mean Difference|1.24||||0.394|TWO_SIDED|95.0|-1.6|4.1|||ANCOVA|||||4.1|-1.6|0.394
72575089|NCT04005352|144676370|SUPERIORITY|Week 64|LS Mean Difference|-0.5||||0.728|TWO_SIDED|95.0|-3.6|2.5|||ANCOVA|||||2.5|-3.6|0.728
72575090|NCT06017479|144676373|OTHER|"Chi-square test as the study used chi-square analysis to compare the incidence of UTIs between the groups (p = 0.660) For this non-inferiority analysis, the study demonstrated that the odds ratio (OR) between the two groups was 0.8 (95% CI: 0.4-1.95), indicating no significant difference. Further details are provided in the study's discussion section."|Odds Ratio (OR)|0.8|STANDARD_DEVIATION|18.125||0.66|TWO_SIDED|95.0|0.4|1.95||The p-value was not adjusted for multiple comparisons as there were no multiple outcome measures being compared in this analysis. The significance threshold (alpha) was set at 0.05.|Chi-squared||"The standard deviations (SD) for the groups are as follows:~For the group receiving 3g fosfomycin: 19.08 For the group receiving 500mg levofloxacin: 17.17"|This randomized controlled trial compared the incidence of UTI between two groups: patients receiving a single dose of 500 mg levofloxacin and patients receiving a single dose of 3 g fosfomycin one hour before a urodynamic study. The null hypothesis is that there is no significant difference in UTI incidence between the two groups. The power calculation was based on a sample size of 126 patients.|A chi-square test was performed to compare the incidence of UTIs between the two groups: patients receiving a single dose of 500 mg levofloxacin and those receiving a single dose of 3 g fosfomycin, both administered one hour before the urodynamic study (UDS). The result showed no statistically significant difference between the two groups (p = 0.660). An odds ratio was also calculated (OR = 0.8, 95% CI: 0.4-1.95), indicating a slightly lower likelihood of UTI in the fosfomycin group, but the difference was not significant.|1.95|0.4|0.660
72575091|NCT00936897|144676374|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.4|||<|0.0001|TWO_SIDED|95.0|1.0|1.8|||ANCOVA||Denosumab - Ibandronate|||1.8|1.0|<0.0001
72575092|NCT00936897|144676375|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
72575093|NCT00936897|144676376|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.2|||<|0.0001|TWO_SIDED|95.0|0.7|1.7|||ANCOVA||Denosumab - Ibandronate|||1.7|0.7|<0.0001
72575094|NCT00936897|144676377|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.0|||<|0.0001|TWO_SIDED|95.0|1.5|2.5|||ANCOVA||Denosumab - Ibandronate|||2.5|1.5|<0.0001
72575095|NCT04058067|144676378|SUPERIORITY||LS mean difference|-1.3|STANDARD_ERROR_OF_MEAN|1.2||0.013|TWO_SIDED|95.0|-3.7|1.1|||ANOVA|||||1.1|-3.7|0.013
72575096|NCT04058067|144676379|SUPERIORITY||LS mean difference|-1.9|STANDARD_ERROR_OF_MEAN|1.15||0.035|TWO_SIDED|95.0|-4.2|0.4|||ANOVA|||||0.4|-4.2|0.035
72575097|NCT04058067|144676381|SUPERIORITY||Difference|-1.1|STANDARD_ERROR_OF_MEAN|0.96|||TWO_SIDED|95.0|-3.0|0.8|||ANOVA|||||0.8|-3.0|
72575098|NCT04058067|144676382|SUPERIORITY||Difference|-1.9|STANDARD_ERROR_OF_MEAN|1.09|||TWO_SIDED|95.0|-4.0|0.2|||ANOVA|||||0.2|-4.0|
72575099|NCT04058067|144676383|SUPERIORITY||Difference|-2.0|STANDARD_ERROR_OF_MEAN|1.14|||TWO_SIDED|95.0|-4.3|0.2|||ANOVA|||||0.2|-4.3|
72575100|NCT04058067|144676386|SUPERIORITY||DIfference|-3.0|||||TWO_SIDED|95.0|-13.7|6.7|||Regression, Logistic|||Proportion of subjects with ≥5 letters gain from baseline or reached BCVA of ≥84 letters at Week 52||6.7|-13.7|
72575101|NCT04058067|144676386|SUPERIORITY||Difference|-2.6|||||TWO_SIDED|95.0|-14.7|9.4|||Regression, Logistic|||Proportion of subjects with ≥10 letters gain from baseline or reached BCVA of ≥84 letters at Week 52||9.4|-14.7|
72575102|NCT04058067|144676386|SUPERIORITY||Difference|-3.8|||||TWO_SIDED|95.0|-15.5|6.9|||Regression, Logistic|||Proportion of subjects with ≥15 letters gain from baseline or reached BCVA of ≥84 letters at Week 52||6.9|-15.5|
72575103|NCT04058067|144676390|SUPERIORITY||DIfference|0.1|||||TWO_SIDED|95.0|-4.2|4.4|||Regression, Logistic|||Proportion of subjects with ≥5 letters loss from baseline at Week 52||4.4|-4.2|
72575104|NCT04058067|144676390|SUPERIORITY||Difference|0.8|||||TWO_SIDED|95.0|-1.6|3.8|||Regression, Logistic|||Proportion of subjects with ≥10 letters loss from baseline at Week 52||3.8|-1.6|
72575105|NCT04058067|144676390|SUPERIORITY||Difference|0.0|||||TWO_SIDED|95.0|-2.2|2.3|||Regression, Logistic|||Proportion of subjects with ≥15 letters loss from baseline at Week 52||2.3|-2.2|
72575106|NCT04058067|144676391|OTHER|Descriptive, Week 4|Difference - %|0.4|||||TWO_SIDED|95.0|-7.9|8.6|||Clopper-Pearson exact method|||Week 4||8.6|-7.9|
72575107|NCT04058067|144676391|OTHER|Descriptive, Week 6|Difference - %|-5.1|||||TWO_SIDED|95.0|-14.3|2.9|||Clopper-Pearson exact method|||Week 6||2.9|-14.3|
72575108|NCT04058067|144676391|OTHER|Descriptive, Week 8|Difference - %|-4.0||||||95.0|-13.3|4.4|||Clopper-Pearson exact method|||Week 8||4.4|-13.3|
72575109|NCT04058067|144676391|OTHER|Descriptive, Week 12|Difference - %|-7.0|||||TWO_SIDED|95.0|-16.4|2.3|||Clopper-Pearson exact method|||Week 12||2.3|-16.4|
72575110|NCT04058067|144676391|OTHER|Descriptive, Week 16|Difference - %|-9.8|||||TWO_SIDED|95.0|-19.2|0.0|||Clopper-Pearson exact method|||Week 16||-0.0|-19.2|
72575111|NCT04058067|144676391|OTHER|Descriptive, Week 18|Difference - %|-9.8|||||TWO_SIDED|95.0|-19.0|0.0|||Clopper-Pearson exact method|||Week 18||-0.0|-19.0|
72575112|NCT04058067|144676391|OTHER|Descriptive, Week 20|Difference - %|-5.7|||||TWO_SIDED|95.0|-15.8|3.9|||Clopper-Pearson exact method|||Week 20||3.9|-15.8|
72575113|NCT04058067|144676391|OTHER|Descriptive, Week 24|Difference - %|-13.4|||||TWO_SIDED|95.0|-23.9|-3.1|||Clopper-Pearson exact method|||Week 24||-3.1|-23.9|
72575114|NCT04058067|144676391|OTHER|Descriptive, Week 28|Difference - %|-12.4|||||TWO_SIDED|95.0|-22.0|-2.1|||Clopper-Pearson exact method|||Week 28||-2.1|-22.0|
72575115|NCT04058067|144676391|OTHER|Descriptive, Week 32|Difference - %|-15.4|||||TWO_SIDED|95.0|-26.0|-4.8|||Clopper-Pearson exact method|||Week 32||-4.8|-26.0|
72575116|NCT04058067|144676391|OTHER|Descriptive, Week 36|Difference - %|-18.8|||||TWO_SIDED|95.0|-29.5|-8.9|||Clopper-Pearson exact method.|||Week 36||-8.9|-29.5|
72575117|NCT04058067|144676391|OTHER|Descriptive, Week 40|Difference - %|-18.4|||||TWO_SIDED|95.0|-28.7|-8.6|||Clopper-Pearson exact method|||Week 40||-8.6|-28.7|
72575118|NCT04058067|144676391|OTHER|Descriptive, Week 44|Difference - %|-14.9|||||TWO_SIDED|95.0|-25.6|-4.4|||Clopper-Pearson exact method|||Week 44||-4.4|-25.6|
72575119|NCT04058067|144676391|OTHER|Descriptive, Week 48|Difference - %|-13.3|||||TWO_SIDED|95.0|-23.6|-3.4|||Clopper-Pearson exact method|||Week 48||-3.4|-23.6|
72409598|NCT02139644|144327599|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|-0.143||||0.001|TWO_SIDED|95.0|-0.229|-0.058||Significance level of 0.05.|mixed model for repeated measures|||The change from baseline in the weekly average of the total daily asthma symptom scores over weeks 1 to 12 was analyzed using an MMRM with an unstructured covariance matrix and with effects due to baseline score, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), week, treatment, and week-by-treatment interaction.||-0.058|-0.229|0.0010
72538586|NCT02675426|144606595|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure.|LS Mean Difference|-51.01|||<|0.001|TWO_SIDED|95.0|-78.14|-23.87||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|Mixed Effect Model Repeat Measurement|MMRM model with fixed effects of treatment, visit, and treatment-by-visit interaction, previous bDMARD use, and Baseline value as covariate.|Treatment Difference = Upadacitinib - Placebo|||-23.87|-78.14|<0.001
72575120|NCT04058067|144676391|OTHER|Descriptive, Week 52|Difference - %|-12.6|||||TWO_SIDED|95.0|-23.5|-2.9|||Clopper-Pearson exact method|||Week 52||-2.9|-23.5|
72575121|NCT04058067|144676392|SUPERIORITY||Difference|-1.3|||||TWO_SIDED|95.0|-13.6|11.2|||Clopper-Pearson exact method|||||11.2|-13.6|
72575122|NCT04058067|144676394|SUPERIORITY||Difference|-10.2|STANDARD_ERROR_OF_MEAN|13.79|||TWO_SIDED|95.0|-37.3|17.0|||ANOVA|||||17.0|-37.3|
72575123|NCT04058067|144676395|SUPERIORITY||Difference|-2.5|STANDARD_ERROR_OF_MEAN|12.34|||TWO_SIDED|95.0|-26.8|21.9|||ANOVA|||||21.9|-26.8|
72575124|NCT04058067|144676396|SUPERIORITY||Difference|-8.5|STANDARD_ERROR_OF_MEAN|11.03|||TWO_SIDED|95.0|-30.3|13.2|||ANOVA|||||13.2|-30.3|
72575125|NCT04058067|144676397|SUPERIORITY||Difference - %|5.3|||||TWO_SIDED|95.0|-3.3|13.5|||Clopper-Pearson exact method|||Week 4||13.5|-3.3|
72538587|NCT02675426|144606595|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure.|LS Mean Difference|-50.86|||<|0.001|TWO_SIDED|95.0|-78.19|-23.53||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|Mixed Effect Model Repeat Measurement|MMRM model with fixed effects of treatment, visit, and treatment-by-visit interaction, previous bDMARD use, and Baseline value as covariate.|Treatment Difference = Upadacitinib - Placebo|||-23.53|-78.19|<0.001
72575126|NCT04058067|144676397|SUPERIORITY||Difference - %|10.8|||||TWO_SIDED|95.0|1.4|20.6|||Clopper-Pearson exact method|||Week 6||20.6|1.4|
72575127|NCT04058067|144676397|SUPERIORITY||Difference - %|14.1|||||TWO_SIDED|95.0|3.9|25.3|||Clopper-Pearson exact method|||Week 8||25.3|3.9|
72409599|NCT02139644|144327599|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|-0.23||||0|TWO_SIDED|95.0|-0.315|-0.144||Significance level of 0.05.|mixed model for repeated measures|||The change from baseline in the weekly average of the total daily asthma symptom scores over weeks 1 to 12 was analyzed using an MMRM with an unstructured covariance matrix and with effects due to baseline score, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), week, treatment, and week-by-treatment interaction.||-0.144|-0.315|0.0000
72575128|NCT04058067|144676397|SUPERIORITY||Difference - %|14.1|||||TWO_SIDED|95.0|2.8|24.9|||Clopper-Pearson exact method||Proportion estimates (%) = 39.3|Week 12||24.9|2.8|
72575129|NCT04058067|144676397|SUPERIORITY||Difference - %|16.8||||||95.0|5.1|28.6|||Clopper-Pearson exact method|||Week 16||28.6|5.1|
72575130|NCT04058067|144676397|SUPERIORITY||Difference - %|15.4|||||TWO_SIDED|95.0|3.1|26.6|||Clopper-Pearson exact method|||Week 18||26.6|3.1|
72575131|NCT04058067|144676397|SUPERIORITY||Difference - %|15.7|||||TWO_SIDED|95.0|3.5|27.1|||Clopper-Pearson exact method|||Week 20||27.1|3.5|
72575132|NCT04058067|144676397|SUPERIORITY||Difference - %|19.1|||||TWO_SIDED|95.0|7.2|30.2|||Clopper-Pearson exact method|||Week 24||30.2|7.2|
72575133|NCT04058067|144676397|SUPERIORITY||Difference - %|16.4|||||TWO_SIDED|95.0|4.9|27.9|||Clopper-Pearson exact method|||Week 28||27.9|4.9|
72575134|NCT04058067|144676397|SUPERIORITY||Difference - %|12.1|||||TWO_SIDED|95.0|0.4|24.4|||Clopper-Pearson exact method|||Week 32||24.4|0.4|
72575135|NCT04058067|144676397|SUPERIORITY||Difference - %|6.0|||||TWO_SIDED|95.0|-5.9|18.0|||Clopper-Pearson exact method|||Week 36||18.0|-5.9|
72575136|NCT04058067|144676397|SUPERIORITY||Difference - %|15.2|||||TWO_SIDED|95.0|3.3|26.1|||Clopper-Pearson exact method|||Week 40||26.1|3.3|
72575137|NCT04058067|144676397|SUPERIORITY||Difference - %|13.2|||||TWO_SIDED|95.0|1.9|25.7|||Clopper-Pearson exact method|||Week 44||25.7|1.9|
72575138|NCT04058067|144676397|SUPERIORITY||Difference - %|11.9|||||TWO_SIDED|95.0|-0.8|23.6|||Clopper-Pearson exact method|||Week 48||23.6|-0.8|
72575139|NCT04058067|144676397|SUPERIORITY||Difference - %|17.9|||||TWO_SIDED|95.0|5.8|30.5|||Clopper-Pearson exact method|||Week 52||30.5|5.8|
72575140|NCT04058067|144676398|SUPERIORITY||Difference|0.9|||||TWO_SIDED|95.0|0.8|3.6|||Clopper-Pearson exact method|||||3.6|0.8|
72575141|NCT04058067|144676399|SUPERIORITY||Difference|-4.3|||||TWO_SIDED|95.0|-13.2|4.6|||Clopper-Pearson exact method|||||4.6|-13.2|
72575142|NCT04058067|144676400|SUPERIORITY||Difference|1.0|||||TWO_SIDED|95.0|-10.5|12.4|||Clopper-Pearson exact method|||||12.4|-10.5|
72575143|NCT04058067|144676405|OTHER|Descriptive, Week 28|Difference - %|-2.4|||||TWO_SIDED|95.0|-13.9|8.8|||Clopper-Pearson exact method|||Week 28||8.8|-13.9|
72575144|NCT04058067|144676405|OTHER|Descriptive, Week 52|Difference - %|-2.8|||||TWO_SIDED|95.0|-14.1|9.0|||Clopper-Pearson exact method|||Week 52||9.0|-14.1|
72575145|NCT04058067|144676407|OTHER|Descriptive, Week 28|Difference - %|4.2|||||TWO_SIDED|95.0|-4.1|12.6|||Clopper-Pearson exact method|||Week 28||12.6|-4.1|
72575146|NCT04058067|144676407|OTHER|Descriptive, Week 52|Difference - %|-0.5|||||TWO_SIDED|95.0|-10.5|9.3|||Clopper-Pearson exact method|||Week 52||9.3|-10.5|
72575147|NCT04058067|144676409|OTHER|Descriptive, Week 28|Difference - %|0.8|||||TWO_SIDED|95.0|0.7|2.9|||Clopper-Pearson exact method|||Week 28||2.9|0.7|
72575148|NCT04058067|144676411|OTHER|Descriptive, Week 28|Difference - %|0.8|||||TWO_SIDED|95.0|0.7|2.9|||Clopper-Pearson exact method|||Week 28||2.9|0.7|
72575149|NCT04058067|144676412|SUPERIORITY||LS mean difference|-0.9||||||95.0|-4.1|2.3|||ANCOVA|||Week 28||2.3|-4.1|
72575150|NCT04058067|144676412|SUPERIORITY||LS mean difference|0.1|||||TWO_SIDED|95.0|-3.1|3.3|||ANCOVA|||Week 52||3.3|-3.1|
72575151|NCT05005312|144676434|OTHER|The ratio and 90% CI were expressed as percentages|Ratio of Adjusted Geometric Means|101.96|||||TWO_SIDED|90.0|74.2|140.11|||ANOVA|||||140.11|74.20|
72627349|NCT05136170|144783683|SUPERIORITY|"Changes from baseline in each IDEEL modules scale score was analyzed using a mixed model for repeated measures (MMRM) adjusting by gender, age class, IDEEL module baseline value, treatment, visit and treatment by visit interaction. Subject was considered as a random effect. The covariance matrix used was unstructured. Comparisons vs vehicle TID were provided using least square means at each visit and overall."|LS means difference|5.232||||0.125|TWO_SIDED|95.0|-1.457|11.922||P-value of LS means difference between treatments from the MMRM on change from baseline in IDEEL DE Symptom Bother Module at Week 4.|Mixed Model for Repeated Measures|||Symptom - Bother - Week 4||11.922|-1.457|0.125
72627350|NCT05136170|144783683|SUPERIORITY|"Changes from baseline in each IDEEL modules scale score was analyzed using a mixed model for repeated measures (MMRM) adjusting by gender, age class, IDEEL module baseline value, treatment, visit and treatment by visit interaction. Subject was considered as a random effect. The covariance matrix used was unstructured. Comparisons vs vehicle TID were provided using least square means at each visit and overall."|LS means difference|-0.156||||0.964|TWO_SIDED|95.0|-6.912|6.6||P-value of LS means difference between treatments from the MMRM on change from baseline in IDEEL DE Symptom Bother Module at Week 12.|Mixed Model for Repeated Measures|||Symptom - Bother - Week 12||6.6|-6.912|0.964
72627351|NCT05136170|144783684|SUPERIORITY||LS means difference|0.795||||0.102|TWO_SIDED|95.0|-0.157|1.748||P-value of LS means difference between treatments from the MMRM on change from baseline at Week 4.|Mixed Model for Repeated Measures|||"Analysis was based on MMRM with Multiple Imputation under missing not at random using retrieve dropouts with change from baseline in TFBUT at each timepoint adjusting by gender, age class, TFBUT scale baseline value, treatment, visit, and treatment by visit interaction. Patient was considered as a random effect and the covariance matrix used was unstructured.~Herein analysis for Week 4 was reported."||1.748|-0.157|0.102
72627352|NCT05136170|144783684|SUPERIORITY||LS means difference|-0.051||||0.923|TWO_SIDED|95.0|-1.094|0.991||P-value of LS means difference between treatments from the MMRM on change from baseline at Week 8.|Mixed Model for Repeated Measures|||"Analysis was based on MMRM with Multiple Imputation under missing not at random using retrieve dropouts with change from baseline in TFBUT at each timepoint adjusting by gender, age class, TFBUT scale baseline value, treatment, visit, and treatment by visit interaction. Patient was considered as a random effect and the covariance matrix used was unstructured.~Herein analysis for Week 8 was reported."||0.991|-1.094|0.923
72627353|NCT05136170|144783684|SUPERIORITY||LS means difference|0.136||||0.787|TWO_SIDED|95.0|-0.849|1.12||P-value of LS means difference between treatments from the MMRM on change from baseline at Week 12|Mixed Model for Repeated Measures|||"Analysis was based on MMRM with Multiple Imputation under missing not at random using retrieve dropouts with change from baseline in TFBUT at each timepoint adjusting by gender, age class, TFBUT scale baseline value, treatment, visit, and treatment by visit interaction. Patient was considered as a random effect and the covariance matrix used was unstructured.~Herein analysis for Week 12 was reported."||1.12|-0.849|0.787
72627354|NCT05136170|144783685|SUPERIORITY||||||<|0.001||||||p-value corresponds to a non-parametric Mann-Whitney-Wilcoxon (Wilcoxon rank sum) test of the comparisons between Cenegermin and Vehicle in all patients.|Wilcoxon (Mann-Whitney)|||Herein analysis for Week 4 (Visit 3) was reported.||||<0.001
72627355|NCT05136170|144783685|SUPERIORITY||||||<|0.001||||||p-value corresponds to a non-parametric Mann-Whitney-Wilcoxon (Wilcoxon rank sum) test of the comparisons between Cenegermin and Vehicle in all patients.|Wilcoxon (Mann-Whitney)|||Herein analysis for Week 8 (Visit 4) was reported.||||<0.001
72627356|NCT05136170|144783685|SUPERIORITY|||||||0.014||||||p-value corresponds to a non-parametric Mann-Whitney-Wilcoxon (Wilcoxon rank sum) test of the comparisons between Cenegermin and Vehicle in all patients.|Wilcoxon (Mann-Whitney)|||Herein analysis for Week 12 (Visit 5) was reported.||||0.014
72627357|NCT05136170|144783685|SUPERIORITY|||||||0.095||||||Not statistically significant result. p-value corresponds to a non-parametric Mann-Whitney-Wilcoxon (Wilcoxon rank sum) test of the comparisons between Cenegermin and Vehicle in all patients.|Wilcoxon (Mann-Whitney)|||Herein analysis for Week 16 (Visit 6) was reported.||||0.095
72627358|NCT05136170|144783686|SUPERIORITY|||||||0.02||||||p-value corresponds to a non-parametric Mann-Whitney-Wilcoxon (Wilcoxon rank sum) test of the comparisons between Cenegermin and Vehicle in all patients.|Wilcoxon (Mann-Whitney)|||Herein analysis for Week 4 (Visit 3) was reported.||||0.02
72627359|NCT05136170|144783686|SUPERIORITY|||||||0.328||||||p-value corresponds to a non-parametric Mann-Whitney-Wilcoxon (Wilcoxon rank sum) test of the comparisons between Cenegermin and Vehicle in all patients.|Wilcoxon (Mann-Whitney)|||Herein analysis for Week 8 (Visit 4) was reported.||||0.328
72575152|NCT05005312|144676435|OTHER|The ratio and 90% CI were expressed as percentages|Ratio of Adjusted Geometric Means|99.29|||||TWO_SIDED|90.0|70.81|139.21|||ANOVA|||||139.21|70.81|
72575153|NCT05005312|144676436|OTHER|The ratio and 90% CI were expressed as percentages|Ratio of Adjusted Geometric Means|98.78|||||TWO_SIDED|90.0|70.65|138.12|||ANOVA|||||138.12|70.65|
72575154|NCT02704403|144676455|SUPERIORITY||Mean Difference (Net)|0.043||||0.0659|TWO_SIDED|95.0|-0.003|0.09|||Regression, Logistic|test is 2-sided, alpha=0.01||The null hypothesis was that there was no difference in response rates between the elafibranor and placebo treatment groups. The alternative hypothesis was that there was a difference in the response rates between the elafibranor and placebo treatment groups.||0.090|-0.003|0.0659
72575155|NCT02704403|144676456|SUPERIORITY||Cox Proportional Hazard|0.95|||||TWO_SIDED|95.0|0.619|1.457|||||No formal test due to the early termination of the study.|||1.457|0.619|
72575156|NCT01442688|144676475|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|If the 90% Confidence Intervals of the geometric mean ratio are wholly contained within the interval (0.80, 1.25), then the hypothesis of a drug interaction will be rejected.|Geometric mean ratio|1.02|||||TWO_SIDED|90.0|0.995|1.04|||ANOVA|||||1.04|0.995|
72627360|NCT05136170|144783686|SUPERIORITY|||||||0.287||||||p-value corresponds to a non-parametric Mann-Whitney-Wilcoxon (Wilcoxon rank sum) test of the comparisons between Cenegermin and Vehicle in all patients.|Wilcoxon (Mann-Whitney)|||Herein analysis for Week 12 (Visit 5) was reported.||||0.287
72627361|NCT05136170|144783686|SUPERIORITY|||||||0.777||||||p-value corresponds to a non-parametric Mann-Whitney-Wilcoxon (Wilcoxon rank sum) test of the comparisons between Cenegermin and Vehicle in all patients.|Wilcoxon (Mann-Whitney)|||Herein analysis for Week 16 (Visit 6) was reported.||||0.777
72409600|NCT02139644|144327599|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|-0.194||||0|TWO_SIDED|95.0|-0.279|-0.109||Significance level of 0.05.|mixed model for repeated measures|||The change from baseline in the weekly average of the total daily asthma symptom scores over weeks 1 to 12 was analyzed using an MMRM with an unstructured covariance matrix and with effects due to baseline score, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), week, treatment, and week-by-treatment interaction.||-0.109|-0.279|0.0000
72575157|NCT01442688|144676476|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|If the 90% Confidence Intervals of the geometric mean ratio are wholly contained within the interval (0.80, 1.25), then the hypothesis of a drug interaction will be rejected.|Geometric mean ratio|0.991|||||TWO_SIDED|90.0|0.94|1.04|||ANOVA|||||1.04|0.940|
72575158|NCT02792699|144676489|OTHER||Geometric LS Mean|152371.4|||||||||||||Estimated using an analysis of covariance model adjusted for weight and geographic region.|||||
72409601|NCT02139644|144327599|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|-0.064||||0.1381|TWO_SIDED|95.0|-0.15|0.021||Significance level of 0.05.|mixed model for repeated measures|||The change from baseline in the weekly average of the total daily asthma symptom scores over weeks 1 to 12 was analyzed using an MMRM with an unstructured covariance matrix and with effects due to baseline score, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), week, treatment, and week-by-treatment interaction.||0.021|-0.150|0.1381
72409602|NCT02139644|144327599|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|-0.051||||0.2438|TWO_SIDED|95.0|-0.136|0.035||Significance level of 0.05.|mixed model for repeated measures|||The change from baseline in the weekly average of the total daily asthma symptom scores over weeks 1 to 12 was analyzed using an MMRM with an unstructured covariance matrix and with effects due to baseline score, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), week, treatment, and week-by-treatment interaction.||0.035|-0.136|0.2438
72409603|NCT02139644|144327599|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|-0.029||||0.5095|TWO_SIDED|95.0|-0.114|0.057||Significance level of 0.05.|mixed model for repeated measures|||The change from baseline in the weekly average of the total daily asthma symptom scores over weeks 1 to 12 was analyzed using an MMRM with an unstructured covariance matrix and with effects due to baseline score, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), week, treatment, and week-by-treatment interaction.||0.057|-0.114|0.5095
72575159|NCT02792699|144676489|OTHER||LS Geometric Mean|159236.0|||||||||||||Estimated using an analysis of covariance model adjusted for weight and geographic region.|||||
72575160|NCT02792699|144676489|OTHER||LS Geometric Mean|172213.2|||||||||||||Estimated using an analysis of covariance model adjusted for weight and geographic region.|||||
72575161|NCT02792699|144676489|EQUIVALENCE|PK similarity between the test (ABP 798) and reference (rituximab \[US\]) for AUCinf was demonstrated if the 90% CI for the GMR following the second infusion of the first dose was within the bioequivalence criteria of 0.8 to 1.25.|Geometric Mean Ratio|0.9569|||||TWO_SIDED|90.0|0.887|1.0323||||||The geometric mean ratio (GMR) and confidence interval (CI) was estimated from an analysis of covariance (ANCOVA) model adjusted for weight and geographic region. The GMR was obtained by exponentiating the difference of the means on the natural log scale. The CI was obtained by exponentiating the CI for the difference between the means on the log scale.||1.0323|0.8870|
72575162|NCT02792699|144676489|EQUIVALENCE|PK similarity between the test (ABP 798) and reference (rituximab \[EU\]) for AUCinf was demonstrated if the 90% CI for the GMR following the second infusion of the first dose was within the bioequivalence criteria of 0.8 to 1.25.|Geometric Mean Ratio|0.8848|||||TWO_SIDED|90.0|0.8204|0.9542||||||The geometric mean ratio (GMR) and confidence interval (CI) was estimated from an analysis of covariance (ANCOVA) model adjusted for weight and geographic region. The GMR was obtained by exponentiating the difference of the means on the natural log scale. The CI was obtained by exponentiating the CI for the difference between the means on the log scale.||0.9542|0.8204|
72575163|NCT02792699|144676489|EQUIVALENCE|PK similarity between the test (rituximab \[US\]) and reference (rituximab \[EU\]) for AUCinf was demonstrated if the 90% CI for the GMR following the second infusion of the first dose was within the bioequivalence criteria of 0.8 to 1.25.|Geometric Mean Ratio|0.9246|||||TWO_SIDED|90.0|0.8575|0.997||||||The geometric mean ratio (GMR) and confidence interval (CI) was estimated from an analysis of covariance (ANCOVA) model adjusted for weight and geographic region. The GMR was obtained by exponentiating the difference of the means on the natural log scale. The CI was obtained by exponentiating the CI for the difference between the means on the log scale.||0.9970|0.8575|
72575164|NCT02792699|144676490|OTHER||Geometric LS Mean|368.43|||||||||||||Estimated using an analysis of covariance model adjusted for weight and geographic region.|||||
72575165|NCT02792699|144676490|OTHER||LS Geometric Mean|374.44|||||||||||||Estimated using an analysis of covariance model adjusted for weight and geographic region.|||||
72575166|NCT02792699|144676490|OTHER||LS Geometric Mean|393.29|||||||||||||Estimated using an analysis of covariance model adjusted for weight and geographic region.|||||
72575167|NCT02792699|144676490|EQUIVALENCE|PK similarity between the test (ABP 798) and reference (rituximab \[US\]) for Cmax was demonstrated if the 90% CI for the GMR following the second infusion of the first dose was within the bioequivalence criteria of 0.8 to 1.25.|Geometric Mean Ratio|0.984|||||TWO_SIDED|90.0|0.9356|1.0348||||||The geometric mean ratio (GMR) and confidence interval (CI) was estimated from an analysis of covariance (ANCOVA) model adjusted for weight and geographic region. The GMR was obtained by exponentiating the difference of the means on the natural log scale. The CI was obtained by exponentiating the CI for the difference between the means on the log scale.||1.0348|0.9356|
72575168|NCT02792699|144676490|EQUIVALENCE|PK similarity between the test (ABP 798) and reference (rituximab \[EU\]) for Cmax was demonstrated if the 90% CI for the GMR following the second infusion of the first dose was within the bioequivalence criteria of 0.8 to 1.25.|Geometric Mean Ratio|0.9368|||||TWO_SIDED|90.0|0.8912|0.9848||||||The geometric mean ratio (GMR) and confidence interval (CI) was estimated from an analysis of covariance (ANCOVA) model adjusted for weight and geographic region. The GMR was obtained by exponentiating the difference of the means on the natural log scale. The CI was obtained by exponentiating the CI for the difference between the means on the log scale.||0.9848|0.8912|
72575169|NCT02792699|144676490|EQUIVALENCE|PK similarity between the test (rituximab \[US\]) and reference (rituximab \[EU\]) for Cmax was demonstrated if the 90% CI for the GMR following the second infusion of the first dose was within the bioequivalence criteria of 0.8 to 1.25.|Geometric Mean Ratio|0.9521|||||TWO_SIDED|90.0|0.9055|1.001||||||The geometric mean ratio (GMR) and confidence interval (CI) was estimated from an analysis of covariance (ANCOVA) model adjusted for weight and geographic region. The GMR was obtained by exponentiating the difference of the means on the natural log scale. The CI was obtained by exponentiating the CI for the difference between the means on the log scale.||1.0010|0.9055|
72575170|NCT02792699|144676491|OTHER||Geometric LS Mean|42203.8|||||||||||||Estimated using an analysis of covariance model adjusted for weight and geographic region.|||||
72575171|NCT02792699|144676491|OTHER||LS Geometric Mean|43378.8|||||||||||||Estimated using an analysis of covariance model adjusted for weight and geographic region.|||||
72575172|NCT02792699|144676491|OTHER||LS Geometric Mean|44925.3|||||||||||||Estimated using an analysis of covariance model adjusted for weight and geographic region.|||||
72576801|NCT00261443|144680653|SUPERIORITY_OR_OTHER_LEGACY||Difference|-1.57||||0.066|TWO_SIDED|95.0|-3.24|0.1||Baseline: ANOVA model, controlling for treatment, mood stabilizer, and index mood episode. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 44 Comparison||0.10|-3.24|0.066
72409604|NCT02139644|144327600|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|-0.463||||0.0004|TWO_SIDED|95.0|-0.716|-0.209||Significance level of 0.05|mixed model for repeated measures|||The change from baseline in the weekly average of total daily (24-hour) use of albuterol/ salbutamol inhalation aerosol (number of inhalations) over weeks 1 to 12 was analyzed using an MMRM with an unstructured covariance matrix and with effects due to baseline value, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), week, treatment, and week-by-treatment interaction.||-0.209|-0.716|0.0004
72409605|NCT02139644|144327600|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|-0.464||||0.0003|TWO_SIDED|95.0|-0.718|-0.211||Significance level of 0.05|mixed model for repeated measures|||The change from baseline in the weekly average of total daily (24-hour) use of albuterol/ salbutamol inhalation aerosol (number of inhalations) over weeks 1 to 12 was analyzed using an MMRM with an unstructured covariance matrix and with effects due to baseline value, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), week, treatment, and week-by-treatment interaction.||-0.211|-0.718|0.0003
72409606|NCT02139644|144327600|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|-0.675||||0|TWO_SIDED|95.0|-0.928|-0.421||Significance level of 0.05|mixed model for repeated measures|||The change from baseline in the weekly average of total daily (24-hour) use of albuterol/ salbutamol inhalation aerosol (number of inhalations) over weeks 1 to 12 was analyzed using an MMRM with an unstructured covariance matrix and with effects due to baseline value, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), week, treatment, and week-by-treatment interaction.||-0.421|-0.928|0.0000
72409607|NCT02139644|144327600|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|-0.704||||0|TWO_SIDED|95.0|-0.957|-0.45||Significance level of 0.05|mixed model for repeated measures|||The change from baseline in the weekly average of total daily (24-hour) use of albuterol/ salbutamol inhalation aerosol (number of inhalations) over weeks 1 to 12 was analyzed using an MMRM with an unstructured covariance matrix and with effects due to baseline value, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), week, treatment, and week-by-treatment interaction.||-0.450|-0.957|0.0000
72409608|NCT02139644|144327600|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|-0.212||||0.1014|TWO_SIDED|95.0|-0.465|0.042||Significance level of 0.05|mixed model for repeated measures|||The change from baseline in the weekly average of total daily (24-hour) use of albuterol/ salbutamol inhalation aerosol (number of inhalations) over weeks 1 to 12 was analyzed using an MMRM with an unstructured covariance matrix and with effects due to baseline value, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), week, treatment, and week-by-treatment interaction.||0.042|-0.465|0.1014
72409609|NCT02139644|144327600|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|-0.239||||0.064|TWO_SIDED|95.0|-0.492|0.014||Significance level of 0.05|mixed model for repeated measures|||The change from baseline in the weekly average of total daily (24-hour) use of albuterol/ salbutamol inhalation aerosol (number of inhalations) over weeks 1 to 12 was analyzed using an MMRM with an unstructured covariance matrix and with effects due to baseline value, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), week, treatment, and week-by-treatment interaction.||0.014|-0.492|0.0640
72409610|NCT02139644|144327600|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|-0.241||||0.0626|TWO_SIDED|95.0|-0.494|0.013||Significance level of 0.05|mixed model for repeated measures|||The change from baseline in the weekly average of total daily (24-hour) use of albuterol/ salbutamol inhalation aerosol (number of inhalations) over weeks 1 to 12 was analyzed using an MMRM with an unstructured covariance matrix and with effects due to baseline value, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), week, treatment, and week-by-treatment interaction.||0.013|-0.494|0.0626
72538588|NCT02675426|144606596|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure.|LS Mean Difference|4.95|||<|0.001|TWO_SIDED|95.0|3.31|6.6||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|Mixed Effect Model Repeat Measurement|MMRM model with fixed effects of treatment, visit, and treatment-by-visit interaction, previous bDMARD use, and Baseline value as covariate.|Treatment Difference = Upadacitinib - Placebo|||6.60|3.31|<0.001
72576802|NCT00261443|144680653|SUPERIORITY_OR_OTHER_LEGACY||Difference|-2.08||||0.014|TWO_SIDED|95.0|-3.73|-0.43||Baseline: ANOVA model, controlling for treatment, mood stabilizer, and index mood episode. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 48 Comparison||-0.43|-3.73|0.014
72409611|NCT02139644|144327601|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1679||||||Significance level of 0.05|Log Rank|||||||0.1679
72409612|NCT02139644|144327601|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1701||||||Significance level of 0.05|Log Rank|||||||0.1701
72409613|NCT02139644|144327601|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0437||||||Significance level of 0.05|Log Rank|||||||0.0437
72409614|NCT02139644|144327601|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1718||||||Significance level of 0.05|Log Rank|||||||0.1718
72409615|NCT02139644|144327601|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3134||||||Significance level of 0.05|Log Rank|||||||0.3134
72538589|NCT02675426|144606596|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure.|LS Mean Difference|4.78|||<|0.001|TWO_SIDED|95.0|3.12|6.44||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|Mixed Effect Model Repeat Measurement|MMRM model with fixed effects of treatment, visit, and treatment-by-visit interaction, previous bDMARD use, and Baseline value as covariate.|Treatment Difference = Upadacitinib - Placebo|||6.44|3.12|<0.001
72575173|NCT02792699|144676491|EQUIVALENCE|PK similarity between the test (ABP 798) and reference (rituximab \[US\]) for AUC0-14day was demonstrated if the 90% CI for the GMR following the second infusion of the first dose was within the bioequivalence criteria of 0.8 to 1.25.|Geometric Mean Ratio|0.9729|||||TWO_SIDED|90.0|0.9174|1.0318||||||The geometric mean ratio (GMR) and confidence interval (CI) was estimated from an analysis of covariance (ANCOVA) model adjusted for weight and geographic region. The GMR was obtained by exponentiating the difference of the means on the natural log scale. The CI was obtained by exponentiating the CI for the difference between the means on the log scale.||1.0318|0.9174|
72576803|NCT00261443|144680653|SUPERIORITY_OR_OTHER_LEGACY||Difference|-2.01||||0.019|TWO_SIDED|95.0|-3.68|-0.34||Baseline: ANOVA model, controlling for treatment, mood stabilizer, and index mood episode. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 52 Comparison||-0.34|-3.68|0.019
72409616|NCT02139644|144327601|SUPERIORITY_OR_OTHER_LEGACY|||||||0.993||||||Significance level of 0.05|Log Rank|||||||0.9930
72575174|NCT02792699|144676491|EQUIVALENCE|PK similarity between the test (ABP 798) and reference (rituximab \[EU\]) for AUC0-14day was demonstrated if the 90% CI for the GMR following the second infusion of the first dose was within the bioequivalence criteria of 0.8 to 1.25.|Geometric Mean Ratio|0.9394|||||TWO_SIDED|90.0|0.8863|0.9958||||||The geometric mean ratio (GMR) and confidence interval (CI) was estimated from an analysis of covariance ANCOVA model adjusted for weight and geographic region. The GMR was obtained by exponentiating the difference of the means on the natural log scale. The CI was obtained by exponentiating the CI for the difference between the means on the log scale.||0.9958|0.8863|
72575175|NCT02792699|144676491|EQUIVALENCE|PK similarity between the test (rituximab \[US\]) and reference (rituximab \[EU\]) for AUC0-14day was demonstrated if the 90% CI for the GMR following the second infusion of the first dose was within the bioequivalence criteria of 0.8 to 1.25.|Geometric Mean Ratio|0.9656|||||TWO_SIDED|90.0|0.9104|1.024||||||The geometric mean ratio (GMR) and confidence interval (CI) was estimated from an ANCOVA model adjusted for weight and geographic region. The GMR was obtained by exponentiating the difference of the means on the natural log scale. The CI was obtained by exponentiating the CI for the difference between the means on the log scale.||1.0240|0.9104|
72538590|NCT02675426|144606597|SUPERIORITY||Response Rate Difference|23.1|||<|0.001|TWO_SIDED|95.0|15.1|31.0||Unadjusted p-value|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification factor of prior biological disease-modifying anti-rheumatoid drug use.|Response Rate Difference = Upadacitinib - Placebo|||31.0|15.1|<0.001
72575176|NCT02792699|144676492|OTHER||Geometric LS Mean|149590.5|||||||||||||Estimated using an analysis of covariance model adjusted for weight and geographic region.|||||
72575177|NCT02792699|144676492|OTHER||LS Geometric Mean|155778.7|||||||||||||Estimated using an analysis of covariance model adjusted for weight and geographic region.|||||
72575178|NCT02792699|144676492|OTHER||LS Geometric Mean|166811.0|||||||||||||Estimated using an analysis of covariance model adjusted for weight and geographic region.|||||
72575179|NCT02792699|144676492|EQUIVALENCE|PK similarity between the test (ABP 798) and reference (rituximab \[US\]) for AUC0-12wk was demonstrated if the 90% CI for the GMR following the second infusion of the first dose was within the bioequivalence criteria of 0.8 to 1.25.|Geometric Mean Ratio|0.9603|||||TWO_SIDED|90.0|0.895|1.0303||||||The geometric mean ratio (GMR) and confidence interval (CI) was estimated from an analysis of covariance (ANCOVA) model adjusted for weight and geographic region. The GMR was obtained by exponentiating the difference of the means on the natural log scale. The CI was obtained by exponentiating the CI for the difference between the means on the log scale.||1.0303|0.8950|
72575180|NCT02792699|144676492|EQUIVALENCE|PK similarity between the test (ABP 798) and reference (rituximab \[EU\]) for AUC0-12wk was demonstrated if the 90% CI for the GMR following the second infusion of the first dose was within the bioequivalence criteria of 0.8 to 1.25.|Geometric Mean Ratio|0.8968|||||TWO_SIDED|90.0|0.8363|0.9616||||||The geometric mean ratio (GMR) and confidence interval (CI) was estimated from an analysis of covariance ANCOVA model adjusted for weight and geographic region. The GMR was obtained by exponentiating the difference of the means on the natural log scale. The CI was obtained by exponentiating the CI for the difference between the means on the log scale.||0.9616|0.8363|
72627362|NCT05136170|144783687|SUPERIORITY|||||||0.126||||||p-value corresponds to a non-parametric Mann-Whitney-Wilcoxon (Wilcoxon rank sum) test of the comparisons between Cenegermin and and Vehicle in all patients.|Wilcoxon (Mann-Whitney)|||Herein analysis for Week 4 (Visit 3) was reported.||||0.126
72627363|NCT05136170|144783687|SUPERIORITY|||||||0.968||||||p-value corresponds to a two sample (independent group) t-test of the comparisons between Cenegermin and Vehicle in all patients.|t-test, 2 sided|||Herein analysis for Week 8 (Visit 4) was reported.||||0.968
72538591|NCT02675426|144606597|SUPERIORITY||Response Rate Difference|28.4|||<|0.001|TWO_SIDED|95.0|20.4|36.5||Unadjusted p-value|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification factor of prior biological disease-modifying anti-rheumatoid drug use.|Response Rate Difference = Upadacitinib - Placebo|||36.5|20.4|<0.001
72538592|NCT02675426|144606598|SUPERIORITY||Response Rate Difference|14.9|||<|0.001|TWO_SIDED|95.0|8.7|21.1||Unadjusted p-value|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification factor of prior biological disease-modifying anti-rheumatoid drug use.|Response Rate Difference = Upadacitinib - Placebo|||21.1|8.7|<0.001
72538593|NCT02675426|144606598|SUPERIORITY||Response Rate Difference|20.6|||<|0.001|TWO_SIDED|95.0|14.0|27.2||Unadjusted p-value|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification factor of prior biological disease-modifying anti-rheumatoid drug use.|Response Rate Difference = Upadacitinib - Placebo|||27.2|14.0|<0.001
72575181|NCT02792699|144676492|EQUIVALENCE|PK similarity between the test (rituximab \[US\]) and reference (rituximab \[EU\]) for AUC0-12wk was demonstrated if the 90% CI for the GMR following the second infusion of the first dose was within the bioequivalence criteria of 0.8 to 1.25.|Geometric Mean Ratio|0.9339|||||TWO_SIDED|90.0|0.8707|1.0016||||||The geometric mean ratio (GMR) and confidence interval (CI) was estimated from an ANCOVA model adjusted for weight and geographic region. The GMR was obtained by exponentiating the difference of the means on the natural log scale. The CI was obtained by exponentiating the CI for the difference between the means on the log scale.||1.0016|0.8707|
72575182|NCT02792699|144676493|OTHER||Geometric LS Mean|304.04|||||||||||||Estimated using an analysis of covariance model adjusted for weight and geographic region.|||||
72575183|NCT02792699|144676493|OTHER||LS Geometric Mean|305.8|||||||||||||Estimated using an analysis of covariance model adjusted for weight and geographic region.|||||
72627364|NCT05136170|144783687|SUPERIORITY|||||||0.613||||||p-value corresponds to a two sample (independent group) t-test of the comparisons between Cenegermin and Vehicle in all patients.|t-test, 2 sided|||Herein analysis for Week 12 (Visit 5) was reported.||||0.613
72409617|NCT02139644|144327601|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9999||||||Significance level of 0.05|Log Rank|||||||0.9999
72409618|NCT02139644|144327602|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|0.301||||0.0044|TWO_SIDED|95.0|0.094|0.508||Significance level of 0.05|ANCOVA|||The change from baseline in AQLQ(S) score (patients ≥18 years of age) at endpoint (ie, last postbaseline observation) was analyzed using an ANCOVA model with effects due to baseline AQLQ(S) score, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), and treatment, imputing missing data via last observation carried forward (LOCF).||0.508|0.094|0.0044
72409619|NCT02139644|144327602|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|0.253||||0.0155|TWO_SIDED|95.0|0.048|0.458||Significance level of 0.05|ANCOVA|||The change from baseline in AQLQ(S) score (patients ≥18 years of age) at endpoint (ie, last postbaseline observation) was analyzed using an ANCOVA model with effects due to baseline AQLQ(S) score, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), and treatment, imputing missing data via last observation carried forward (LOCF).||0.458|0.048|0.0155
72409620|NCT02139644|144327602|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|0.473||||0|TWO_SIDED|95.0|0.27|0.676||Significance level of 0.05|ANCOVA|||The change from baseline in AQLQ(S) score (patients ≥18 years of age) at endpoint (ie, last postbaseline observation) was analyzed using an ANCOVA model with effects due to baseline AQLQ(S) score, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), and treatment, imputing missing data via last observation carried forward (LOCF).||0.676|0.270|0.0000
72538594|NCT02675426|144606599|SUPERIORITY||Response Rate Difference|13.6|||<|0.001|TWO_SIDED|95.0|7.0|20.2||Unadjusted p-value|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification factor of prior biological disease-modifying anti-rheumatoid drug use.|Response Rate Difference = Upadacitinib - Placebo|||20.2|7.0|<0.001
72538595|NCT02675426|144606599|SUPERIORITY||Response Rate Difference|19.7|||<|0.001|TWO_SIDED|95.0|12.7|26.7||Unadjusted p-value|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification factor of prior biological disease-modifying anti-rheumatoid drug use|Response Rate Difference = Upadacitinib - Placebo|||26.7|12.7|<0.001
72538596|NCT02953262|144606607|SUPERIORITY|||||||0.057||||||The a priori threshold for statistical significance was p=0.05.|Chi-squared|||||||0.057
72538597|NCT02953262|144606607|SUPERIORITY|||||||0.753||||||The a priori threshold for statistical significance was p=0.05.|Chi-squared|||||||0.753
72538598|NCT02953262|144606607|SUPERIORITY|||||||0.613||||||The a priori threshold for statistical significance was p=0.05.|Chi-squared|||||||0.613
72538599|NCT02953262|144606608|SUPERIORITY|||||||0.308||||||The a priori threshold for statistical significance was p=0.05.|Chi-squared|||||||0.308
72575184|NCT02792699|144676493|OTHER||LS Geometric Mean|320.87|||||||||||||Estimated using an analysis of covariance model adjusted for weight and geographic region.|||||
72409621|NCT02139644|144327602|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|0.23||||0.0293|TWO_SIDED|95.0|0.023|0.437||Significance level of 0.05|ANCOVA|||The change from baseline in AQLQ(S) score (patients ≥18 years of age) at endpoint (ie, last postbaseline observation) was analyzed using an ANCOVA model with effects due to baseline AQLQ(S) score, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), and treatment, imputing missing data via last observation carried forward (LOCF).||0.437|0.023|0.0293
72409622|NCT02139644|144327602|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|0.172||||0.0913|TWO_SIDED|95.0|-0.028|0.372||Significance level of 0.05|ANCOVA|||The change from baseline in AQLQ(S) score (patients ≥18 years of age) at endpoint (ie, last postbaseline observation) was analyzed using an ANCOVA model with effects due to baseline AQLQ(S) score, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), and treatment, imputing missing data via last observation carried forward (LOCF).||0.372|-0.028|0.0913
72409623|NCT02139644|144327602|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|-0.023||||0.8216|TWO_SIDED|95.0|-0.223|0.177||Significance level of 0.05|ANCOVA|||The change from baseline in AQLQ(S) score (patients ≥18 years of age) at endpoint (ie, last postbaseline observation) was analyzed using an ANCOVA model with effects due to baseline AQLQ(S) score, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), and treatment, imputing missing data via last observation carried forward (LOCF).||0.177|-0.223|0.8216
72538600|NCT02953262|144606608|SUPERIORITY|||||||0.154||||||The a priori threshold for statistical significance was p=0.05.|Chi-squared|||||||0.154
72538601|NCT02953262|144606608|SUPERIORITY|||||||0.025||||||The a priori threshold for statistical significance was p=0.05.|Chi-squared|||||||0.025
72538602|NCT02953262|144606609|SUPERIORITY|||||||0.102||||||The a priori threshold for statistical significance was p=0.05.|Chi-squared|||||||0.102
72538603|NCT02953262|144606609|SUPERIORITY|||||||0.023||||||The a priori threshold for statistical significance was p=0.05.|Chi-squared|||||||0.023
72538604|NCT02953262|144606609|SUPERIORITY|||||||0.439||||||The a priori threshold for statistical significance was p=0.05.|Chi-squared|||||||0.439
72538605|NCT02953262|144606610|SUPERIORITY|||||||0.982||||||The a priori threshold for statistical significance was p=0.05.|Chi-squared|||||||0.982
72538606|NCT02953262|144606610|SUPERIORITY|||||||0.559||||||The a priori threshold for statistical significance was p=0.05.|Chi-squared|||||||0.559
72538607|NCT02953262|144606610|SUPERIORITY|||||||0.032||||||The a priori threshold for statistical significance was p=0.05.|Chi-squared|||||||0.032
72538608|NCT04662086|144606636|OTHER|||||||0.2||||||A p-value of \<0.05 would be considered statistically significant.|Linear mixed-effects regression model|||A generalized linear mixed effects model with parameterization was utilized to capture the difference in change in viral shedding at day 10 between treatment arms. SARS-CoV2 viral RNA CT values were transformed using a standard Reference curve.||||0.20
72575185|NCT02792699|144676493|EQUIVALENCE|PK similarity between the test (ABP 798) and reference (rituximab \[US\]) for Cmax was demonstrated if the 90% CI for the GMR following the second infusion of the first dose was within the bioequivalence criteria of 0.8 to 1.25.|Geometric Mean Ratio|0.9942|||||TWO_SIDED|90.0|0.9461|1.0448||||||The geometric mean ratio (GMR) and confidence interval (CI) was estimated from an ANCOVA model adjusted for weight and geographic region. The GMR was obtained by exponentiating the difference of the means on the natural log scale. The CI was obtained by exponentiating the CI for the difference between the means on the log scale.||1.0448|0.9461|
72627365|NCT05136170|144783687|SUPERIORITY|||||||0.805||||||p-value corresponds to a two sample (independent group) t-test of the comparisons between Cenegermin and Vehicle in all patients.|t-test, 2 sided|||Herein analysis for Week 16 (Visit 6) was reported.||||0.805
72409624|NCT02139644|144327602|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|-0.071||||0.4934|TWO_SIDED|95.0|-0.275|0.133||Significance level of 0.05|ANCOVA|||The change from baseline in AQLQ(S) score (patients ≥18 years of age) at endpoint (ie, last postbaseline observation) was analyzed using an ANCOVA model with effects due to baseline AQLQ(S) score, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), and treatment, imputing missing data via last observation carried forward (LOCF).||0.133|-0.275|0.4934
72409625|NCT03328897|144327605|SUPERIORITY||Mean Difference (Net)|-4.23|STANDARD_ERROR_OF_MEAN|0.746|<|0.001|TWO_SIDED|95.0|-5.7|-2.77|||Mixed Model with Repeated Measures(MMRM)|||||-2.77|-5.70|<0.001
72409626|NCT03328897|144327605|SUPERIORITY||Mean Difference (Net)|-3.79|STANDARD_ERROR_OF_MEAN|0.738|<|0.001|TWO_SIDED|95.0|-5.24|-2.33|||Mixed Model with Repeated Measures(MMRM)|||||-2.33|-5.24|<0.001
72409627|NCT03328897|144327606|SUPERIORITY||Mean Difference (Net)|-10.19|STANDARD_ERROR_OF_MEAN|1.555|<|0.001|TWO_SIDED|95.0|-13.25|-7.14|||Mixed Model with Repeated Measures(MMRM)|||||-7.14|-13.25|<0.001
72409628|NCT03328897|144327606|SUPERIORITY||Mean Difference (Net)|-9.12|STANDARD_ERROR_OF_MEAN|1.535|<|0.001|TWO_SIDED|95.0|-12.14|-6.1|||Mixed Model with Repeated Measures(MMRM)|||||-6.10|-12.14|<0.001
72409629|NCT03328897|144327607|SUPERIORITY||Mean Difference (Net)|-5.92|STANDARD_ERROR_OF_MEAN|0.853|<|0.001|TWO_SIDED|95.0|-7.59|-4.24|||Mixed Model with Repeated Measures(MMRM)|||||-4.24|-7.59|<0.001
72409630|NCT03328897|144327607|SUPERIORITY||Mean Difference (Net)|-5.35|STANDARD_ERROR_OF_MEAN|0.842|<|0.001|TWO_SIDED|95.0|-7.0|-3.69|||Mixed Model with Repeated Measures(MMRM)|||||-3.69|-7.00|<0.001
72409631|NCT03328897|144327608|SUPERIORITY||Odds Ratio (OR)|7.02|||<|0.001|TWO_SIDED|95.0|3.27|15.06|||Regression, Logistic|||||15.06|3.27|<0.001
72538609|NCT04662086|144606637|OTHER||Hazard Ratio (HR)|0.6||||0.07|TWO_SIDED|95.0|0.34|1.04||A p-value of \<0.05 would be considered statistically significant.|Cox proportional hazards model|Two-sided Cox proportional hazards model adjusted for age, sex, and receipt of baseline receipt of monoclonal antibodies.||A two-sided log rank test at the 0.04999 level of significance for the final analysis required 78 events (i.e., sustained symptom resolution) to provide 80% power to detect a hazard ratio of 1.91. Based on previous outpatient COVID-19 trials at Stanford, assumed placebo and treatment arm median time to symptom resolution of 10 and 5 days, respectively, for a total sample size of 120 patients. Participants with missing data lasting through Day 28 were censored on Day 28.||1.04|0.34|0.07
72576804|NCT00261443|144680655|SUPERIORITY_OR_OTHER_LEGACY||Difference|0.05||||0.597|TWO_SIDED|95.0|-0.13|0.22||Baseline: ANOVA model, controlling for treatment, mood stabilizer, and index mood episode. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Baseline Comparison||0.22|-0.13|0.597
72409632|NCT03328897|144327608|SUPERIORITY||Odds Ratio (OR)|7.03|||<|0.001|TWO_SIDED|95.0|3.29|15.06|||Regression, Logistic|||||15.06|3.29|<0.001
72409633|NCT03328897|144327609|SUPERIORITY||Odds Ratio (OR)|11.21|||<|0.001|TWO_SIDED|95.0|3.88|32.37|||Regression, Logistic|||||32.37|3.88|<0.001
72409634|NCT03328897|144327609|SUPERIORITY||Odds Ratio (OR)|5.88||||0.001|TWO_SIDED|95.0|2.01|17.17|||Regression, Logistic|||||17.17|2.01|0.001
72409635|NCT03328897|144327610|SUPERIORITY||Odds Ratio (OR)|2.73|||<|0.001|TWO_SIDED|95.0|1.51|4.95|||Regression, Logistic|||||4.95|1.51|<0.001
72409636|NCT03328897|144327610|SUPERIORITY||Odds Ratio (OR)|2.53||||0.002|TWO_SIDED|95.0|1.41|4.56|||Regression, Logistic|||||4.56|1.41|0.002
72409637|NCT03328897|144327611|SUPERIORITY||Mean Difference (Net)|-4.0|STANDARD_ERROR_OF_MEAN|0.85|<|0.001|TWO_SIDED|95.0|-5.7|-2.3|||Mixed Model with Repeated Measures(MMRM)|||||-2.3|-5.7|<0.001
72409638|NCT03328897|144327611|SUPERIORITY||Mean Difference (Net)|-3.5|STANDARD_ERROR_OF_MEAN|0.85|<|0.001|TWO_SIDED|95.0|-5.1|-1.8|||Mixed Model with Repeated Measures(MMRM)|||||-1.8|-5.1|<0.001
72409639|NCT03328897|144327612|SUPERIORITY||Hazard Ratio (HR)|1.71|||<|0.001|TWO_SIDED|95.0|1.25|2.33|||Regression, Cox|||||2.33|1.25|<0.001
72409640|NCT03328897|144327612|SUPERIORITY||Hazard Ratio (HR)|1.66||||0.001|TWO_SIDED|95.0|1.22|2.25|||Regression, Cox|||||2.25|1.22|0.001
72409641|NCT03143829|144327642|OTHER|||||||0.083|||||||t-test, 2 sided|||Differences at week 10||||0.083
72409642|NCT03143829|144327643|OTHER|||||||0.099|||||||t-test, 2 sided|||Descriptive comparison||||.099
72409643|NCT03143829|144327644|OTHER|||||||0.558|||||||t-test, 2 sided|||comparison at time 4||||.558
72409644|NCT03143829|144327645|OTHER|||||||0.153|||||||Chi-squared|||descriptive comparison of resource use||||.153
72538610|NCT04662086|144606639|OTHER||Hazard Ratio (HR)|0.62||||0.05|TWO_SIDED|95.0|0.38|1.01|||Linear mixed-effects regression model|||||1.01|0.38|0.05
72409645|NCT01257204|144327695|SUPERIORITY_OR_OTHER||Difference|20.8|||||TWO_SIDED|80.0|4.9|36.8|||||The difference in the percentage of participants with antiviral response between daclatasvir and placebo was presented with a difference estimate (daclatasvir - placebo) and 80% confidence Interval.|||36.8|4.9|
72409646|NCT01257204|144327695|SUPERIORITY_OR_OTHER||Difference|20.1|||||TWO_SIDED|80.0|3.9|36.3|||||The difference in the percentage of participants with antiviral response between daclatasvir and placebo was presented with a difference estimate (daclatasvir - placebo) and 80% confidence Interval.|||36.3|3.9|
72409647|NCT01257204|144327704|SUPERIORITY_OR_OTHER||Difference|10.0|||||TWO_SIDED|80.0|-6.8|26.7|||||The difference in the percentage of participants with antiviral response between daclatasvir and placebo was presented with a difference estimate (daclatasvir - placebo) and 80% confidence Interval.|||26.7|-6.8|
72409648|NCT01257204|144327704|SUPERIORITY_OR_OTHER||Difference|7.4|||||TWO_SIDED|80.0|-9.4|24.2|||||The difference in the percentage of participants with antiviral response between daclatasvir and placebo was presented with a difference estimate (daclatasvir - placebo) and 80% confidence Interval.|||24.2|-9.4|
72409649|NCT00491244|144327707|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.8|||<|0.001|TWO_SIDED|95.0|1.46|2.21|||Chi-squared|||||2.21|1.46|< 0.001
72409650|NCT00491244|144327708|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.61||||0.35|TWO_SIDED|95.0|0.65|4.01|||Chi-squared|||||4.01|0.65|0.35
72409651|NCT01276327|144327709|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence of the FDC tablet compared with the individual tablets of linagliptin and pioglitazone administered together|Adjusted gMean Ratio (Test/Ref) (%)|99.92|STANDARD_ERROR_OF_MEAN|1.02|||TWO_SIDED|90.0|97.11|102.81|||Unscaled average Bioequivalence||Geometric standard error of mean was calculated.|||102.81|97.11|
72409652|NCT01276327|144327710|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence of the FDC tablet compared with the individual tablets of linagliptin and pioglitazone administered together|Adjusted gMean Ratio (Test/Ref) (%)|94.17|STANDARD_ERROR_OF_MEAN|1.03|||TWO_SIDED|90.0|89.08|99.55|||Unscaled average Bioequivalence||Geometric Standard error of mean was calculated.|||99.55|89.08|
72538611|NCT04662086|144606640|OTHER||Hazard Ratio (HR)|0.59|||||TWO_SIDED|95.0|0.34|1.01||||||||1.01|0.34|
72538612|NCT04662086|144606641|OTHER|||||||0.21||||||A p-value of \<0.05 would be considered statistically significant.|Fisher Exact|||Difference in incidence of ED visits||||0.21
72538613|NCT01856686|144606643|SUPERIORITY_OR_OTHER_LEGACY|||||||0.56593|||||||ANCOVA|||Between-Group Comparison||||0.56593
72409653|NCT01276327|144327711|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence of the FDC tablet compared with the individual tablets of linagliptin and pioglitazone administered together.|Adjusted gMean Ratio (Test/Ref) (%)|79.99|STANDARD_ERROR_OF_MEAN|1.04|||TWO_SIDED|90.0|74.65|85.72|||Scaled average bioequivalence (SABE)||Geometric Standard error of mean was calculated.|||85.72|74.65|
72409654|NCT01276327|144327712|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence of the FDC tablet compared with the individual tablets of linagliptin and pioglitazone administered together|Adjusted gMean Ratio (Test/Ref) (%)|97.31|STANDARD_ERROR_OF_MEAN|1.06|||TWO_SIDED|90.0|88.9|106.51|||Scaled average bioequivalence (SABE)||Geometric standard error of mean was calculated.|||106.51|88.90|
72538614|NCT01856686|144606643|SUPERIORITY_OR_OTHER_LEGACY|||||||0.44929|||||||Paired t-test|||Within-group comparisons between the baseline and 3 month data||||0.44929
72538615|NCT01856686|144606643|SUPERIORITY_OR_OTHER_LEGACY|||||||0.81844|||||||Paired t-test|||Within-group comparisons between the baseline and 3 month data||||0.81844
72538616|NCT01856686|144606644|SUPERIORITY_OR_OTHER_LEGACY|||||||0.71152|||||||ANCOVA|||Between-Group Comparison||||0.71152
72538617|NCT01856686|144606644|SUPERIORITY_OR_OTHER_LEGACY|||||||0.27795|||||||Paired t-test|||Within-group comparisons between the baseline and 3 month data||||0.27795
72538618|NCT01856686|144606644|SUPERIORITY_OR_OTHER_LEGACY|||||||0.47616|||||||Paired t-test|||Within-group comparisons between the baseline and 3 month data||||0.47616
72538619|NCT01856686|144606645|SUPERIORITY_OR_OTHER_LEGACY|||||||0.10036|||||||ANCOVA|||Between-Group Comparison||||0.10036
72538620|NCT01856686|144606645|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0082|||||||Paired t-test|||Within-group changes||||0.00820
72575186|NCT02792699|144676493|EQUIVALENCE|PK similarity between the test (ABP 798) and reference (rituximab \[EU\]) for Cmax was demonstrated if the 90% CI for the GMR following the second infusion of the first dose was within the bioequivalence criteria of 0.8 to 1.25.|Geometric Mean Ratio|0.9475|||||TWO_SIDED|90.0|0.9021|0.9953||||||The geometric mean ratio (GMR) and confidence interval (CI) was estimated from an ANCOVA model adjusted for weight and geographic region. The GMR was obtained by exponentiating the difference of the means on the natural log scale. The CI was obtained by exponentiating the CI for the difference between the means on the log scale.||0.9953|0.9021|
72538621|NCT01856686|144606645|SUPERIORITY_OR_OTHER_LEGACY|||||||1|||||||Paired t-test|||Within-group comparisons between the baseline and 3 month data||||1.00000
72538622|NCT01856686|144606646|SUPERIORITY_OR_OTHER_LEGACY|||||||0.92193|||||||ANCOVA|||Between-Group Comparison||||0.92193
72538623|NCT01856686|144606646|SUPERIORITY_OR_OTHER_LEGACY|||||||0.50704|||||||Paired t-test|||Within-group comparisons between the baseline and 3 month data||||0.50704
72538624|NCT01856686|144606646|SUPERIORITY_OR_OTHER_LEGACY|||||||0.42314|||||||Paired t-test|||Within-group comparisons between the baseline and 3 month data||||0.42314
72538625|NCT01856686|144606647|SUPERIORITY_OR_OTHER_LEGACY|||||||0.08946|||||||ANCOVA|||Between-Group Comparison||||0.08946
72538626|NCT01856686|144606647|SUPERIORITY_OR_OTHER_LEGACY|||||||0.27795|||||||Paired t-test|||Within-group comparisons between the baseline and 3 month data||||0.27795
72538627|NCT01856686|144606647|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0109|||||||Paired t-test|||Within-group comparisons between the baseline and 3 month data||||0.01090
72538628|NCT01856686|144606648|SUPERIORITY_OR_OTHER_LEGACY|||||||0.73209|||||||ANCOVA|||Between-Group Comparison||||0.73209
72538629|NCT01856686|144606648|SUPERIORITY_OR_OTHER_LEGACY|||||||0.07965|||||||Paired t-test|||Within-group comparisons between the baseline and 3 month data||||0.07965
72538630|NCT01856686|144606648|SUPERIORITY_OR_OTHER_LEGACY|||||||0.61613|||||||Paired t-test|||Within-group comparisons between the baseline and 3 month data||||0.61613
72538631|NCT01856686|144606649|SUPERIORITY_OR_OTHER_LEGACY|||||||0.33027|||||||ANCOVA|||Between-Group Comparison||||0.33027
72538632|NCT01856686|144606649|SUPERIORITY_OR_OTHER_LEGACY|||||||0.00013|||||||Paired t-test|||Within-group comparisons between the baseline and 3 month data||||0.00013
72538633|NCT01856686|144606649|SUPERIORITY_OR_OTHER_LEGACY|||||||0.28019|||||||Paired t-test|||Within-group comparisons between the baseline and 3 month data||||0.28019
72538634|NCT01856686|144606650|SUPERIORITY_OR_OTHER_LEGACY|||||||0.94449|||||||ANCOVA|||Between-Group Comparison||||0.94449
72538635|NCT01856686|144606650|SUPERIORITY_OR_OTHER_LEGACY|||||||0.94574|||||||Paired t-test|||Within-group comparisons between the baseline and 3 month data||||0.94574
72538636|NCT01856686|144606650|SUPERIORITY_OR_OTHER_LEGACY|||||||0.85428|||||||Paired t-test|||Within-group comparisons between the baseline and 3 month data||||0.85428
72538637|NCT01856686|144606651|SUPERIORITY_OR_OTHER_LEGACY|||||||0.83929|||||||ANCOVA|||Between-Group Comparison||||0.83929
72538638|NCT01856686|144606651|SUPERIORITY_OR_OTHER_LEGACY|||||||0.97213|||||||Paired t-test|||Within-group comparisons between the baseline and 3 month data||||0.97213
72538639|NCT01856686|144606651|SUPERIORITY_OR_OTHER_LEGACY|||||||0.58323|||||||Paired t-test|||Within-group comparisons between the baseline and 3 month data||||0.58323
72538640|NCT01856686|144606652|SUPERIORITY_OR_OTHER_LEGACY|||||||0.05158|||||||ANCOVA|||Between-Group Comparison||||0.05158
72575187|NCT02792699|144676493|EQUIVALENCE|PK similarity between the test (rituximab \[US\]) and reference (rituximab \[EU\]) for Cmax was demonstrated if the 90% CI for the GMR following the second infusion of the first dose was within the bioequivalence criteria of 0.8 to 1.25.|Geometric Mean Ratio|0.9531|||||TWO_SIDED|90.0|0.907|1.0015||||||The geometric mean ratio (GMR) and confidence interval (CI) was estimated from an ANCOVA model adjusted for weight and geographic region. The GMR was obtained by exponentiating the difference of the means on the natural log scale. The CI was obtained by exponentiating the CI for the difference between the means on the log scale.||1.0015|0.9070|
72575188|NCT02792699|144676502|EQUIVALENCE|Clinical equivalence was tested by comparing the 2-sided 90% CI of the change from baseline at week 24 of DAS28-CRP between ABP 798 and rituximab with an equivalence margin of (-0.6, 0.6).|LS Mean Difference|0.02|||||TWO_SIDED|90.0|-0.225|0.264||||||If PK similarity was established between rituximab (US) and rituximab (EU), the 2 rituximab arms were to be combined into a single reference group for the primary assessment of clinical equivalence of DAS28-CRP change from baseline at week 24 using a repeated measures analysis with DAS28-CRP change from baseline as the response and the stratification variables, visit, treatment, treatment-by-visit interaction and baseline DAS28-CRP as predictors, and unstructured covariance matrix in the model.||0.264|-0.225|
72575189|NCT02792699|144676502|OTHER||LS Mean Difference|-0.07|||||TWO_SIDED|90.0|-0.353|0.213||||||||0.213|-0.353|
72575190|NCT02792699|144676502|OTHER||LS Mean Difference|0.11|||||TWO_SIDED|90.0|-0.171|0.392||||||||0.392|-0.171|
72575191|NCT02792699|144676503|OTHER||LS Mean Difference|0.064|||||TWO_SIDED|90.0|-0.203|0.33||||||Analysis of change from baseline at week 8, based on an ANCOVA model adjusted for baseline DAS28-CRP and the stratification variables geographic region, seropositivity, and number of prior biologic therapies used for RA.||0.330|-0.203|
72575192|NCT02792699|144676503|OTHER||LS Mean Difference|-0.147|||||TWO_SIDED|90.0|-0.411|0.117||||||Analysis of change from baseline at week 8, based on an ANCOVA model adjusted for baseline DAS28-CRP and the stratification variables geographic region, seropositivity, and number of prior biologic therapies used for RA.||0.117|-0.411|
72575193|NCT02792699|144676503|OTHER||LS Mean Difference|0.502|||||TWO_SIDED|90.0|0.233|0.772||||||Analysis of change from baseline at week 12, based on an ANCOVA model adjusted for baseline DAS28-CRP and the stratification variables geographic region, seropositivity, and number of prior biologic therapies used for RA.||0.772|0.233|
72575194|NCT02792699|144676503|OTHER||LS Mean Difference|0.27|||||TWO_SIDED|90.0|0.0|0.539||||||Analysis of change from baseline at week 12, based on an ANCOVA model adjusted for baseline DAS28-CRP and the stratification variables geographic region, seropositivity, and number of prior biologic therapies used for RA.||0.539|0.000|
72575195|NCT02792699|144676503|OTHER||LS Mean Difference|0.255|||||TWO_SIDED|90.0|-0.04|0.55||||||Analysis of change from baseline at week 40, based on an ANCOVA model adjusted for baseline DAS28-CRP and the stratification variables geographic region, seropositivity, and number of prior biologic therapies used for RA.||0.550|-0.040|
72409655|NCT01276327|144327713|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence of the FDC tablet compared with the individual tablets of linagliptin and pioglitazone administered together|Adjusted gMean Ratio (Test/Ref) (%)|99.92|STANDARD_ERROR_OF_MEAN|1.02|||TWO_SIDED|90.0|97.1|102.81|||Unscaled average bioequivalence||Geometric Standard error of mean was calculated.|||102.81|97.10|
72409656|NCT01276327|144327714|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence of the FDC tablet compared with the individual tablets of linagliptin and pioglitazone administered together|Adjusted gMean Ratio (Test/Ref) (%)|101.85|STANDARD_ERROR_OF_MEAN|1.02|||TWO_SIDED|90.0|98.18|105.67|||Unscaled average bioequivalence||Geometric standard error of mean was calculated.|||105.67|98.18|
72575196|NCT02792699|144676503|OTHER||LS Mean Difference|0.16|||||TWO_SIDED|90.0|-0.135|0.455||||||Analysis of change from baseline at week 40, based on an ANCOVA model adjusted for baseline DAS28-CRP and the stratification variables geographic region, seropositivity, and number of prior biologic therapies used for RA.||0.455|-0.135|
72575197|NCT02792699|144676503|OTHER||LS Mean Difference|0.262|||||TWO_SIDED|90.0|-0.04|0.564||||||Analysis of change from baseline at week 48, based on an ANCOVA model adjusted for baseline DAS28-CRP and the stratification variables geographic region, seropositivity, and number of prior biologic therapies used for RA.||0.564|-0.040|
72575198|NCT02792699|144676503|OTHER||LS Mean Difference|0.08|||||TWO_SIDED|90.0|-0.216|0.376||||||Analysis of change from baseline at week 48, based on an ANCOVA model adjusted for baseline DAS28-CRP and the stratification variables geographic region, seropositivity, and number of prior biologic therapies used for RA.||0.376|-0.216|
72409657|NCT01276327|144327715|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence of the FDC tablet compared with the individual tablets of linagliptin and pioglitazone administered together|Adjusted gMean Ratio (Test/Ref) (%)|80.79|STANDARD_ERROR_OF_MEAN|1.04|||TWO_SIDED|90.0|75.6|86.34|||Scaled average bioequivalence (SABE)||Geometric standard error of mean was calculated.|||86.34|75.60|
72409658|NCT00807092|144327718|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.013|STANDARD_ERROR_OF_MEAN|0.666||||95.0|-1.332|1.306||A statistical significant threshold p less than 0.025|ANCOVA|Treatment and strata as factors; baseline (visit 2) value of mean IAUC(0-4hours) as covariate|BIAsp 30 - BHI 30|"The null hypothesis (H0) was:~H0: Change in mean IAUC(0-4hours) of BIAsp 30 after 6 weeks of treatment-Change in mean IAUC(0-4hours) of BHI 30 after 6 weeks of treatment greater than or equal to 0 mol\*h/L against the alternative hypothesis(H1): H1: Change in mean IAUC (0-4hours) of BIAsp 30 after 6 weeks of treatment-Change in mean IAUC(0-4hours) of BHI 30 after 6 weeks of treatment less than 0 mol\*h/L"||1.306|-1.332|
72627366|NCT05136170|144783688|SUPERIORITY|||||||0.543||||||p-value corresponds to two sample (independent group) t-test of the comparisons between Cenegermin and Vehicle in all patients.|t-test, 2 sided|||Herein analysis for Global score - Week 8 (Visit 4) was reported.||||0.543
72575199|NCT02792699|144676504|OTHER||Risk Ratio (RR)|0.9339|||||TWO_SIDED|90.0|0.7696|1.1332||||||Risk ratio (ABP 798/ABP 798 versus Rituximab \[EU\]/Rituximab \[EU\]) at week 8, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||1.1332|0.7696|
72575200|NCT02792699|144676504|OTHER||Risk Difference (RD)|-0.036|||||TWO_SIDED|90.0|-0.1495|0.0775||||||Risk difference (ABP 798/ABP 798 - Rituximab \[EU\]/Rituximab \[EU\]) at week 8, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||0.0775|-0.1495|
72627367|NCT05136170|144783688|SUPERIORITY|||||||0.677||||||p-value corresponds to two sample (independent group) t-test of the comparisons between Cenegermin and Vehicle in all patients.|t-test, 2 sided|||Herein analysis for Global score - Week 12 (Visit 5) was reported.||||0.677
72538641|NCT01856686|144606652|SUPERIORITY_OR_OTHER_LEGACY|||||||0.94574|||||||Paired t-test|||Within-group comparisons between the baseline and 3 month data||||0.94574
72538642|NCT01856686|144606652|SUPERIORITY_OR_OTHER_LEGACY|||||||0.09331|||||||Paired t-test|||Within-group comparisons between the baseline and 3 month data||||0.09331
72538643|NCT01856686|144606653|SUPERIORITY_OR_OTHER_LEGACY|||||||0.17383|||||||ANCOVA|||Between-Group Comparison||||0.17383
72538644|NCT01856686|144606653|SUPERIORITY_OR_OTHER_LEGACY|||||||0.00092|||||||Paired t-test|||Within-group comparisons between the baseline and 3 month data||||0.00092
72538645|NCT01856686|144606653|SUPERIORITY_OR_OTHER_LEGACY|||||||0.15544|||||||Paired t-test|||Within-group comparisons between the baseline and 3 month data||||0.15544
72575201|NCT02792699|144676504|OTHER||Risk Ratio (RR)|1.0392|||||TWO_SIDED|90.0|0.8436|1.2801||||||Risk ratio (ABP 798/ABP 798 versus Rituximab \[US\]/ABP 798\]) at week 8, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||1.2801|0.8436|
72575202|NCT02792699|144676504|OTHER||Risk Difference (RD)|0.0246|||||TWO_SIDED|90.0|-0.091|0.1402||||||Risk difference (ABP 798/ABP 798 - Rituximab \[US\]/ABP 798) at week 8, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||0.1402|-0.0910|
72538646|NCT01856686|144606654|SUPERIORITY_OR_OTHER_LEGACY|||||||0.39707|||||||ANCOVA|||Between-Group Comparison||||0.39707
72538647|NCT01856686|144606654|SUPERIORITY_OR_OTHER_LEGACY|||||||0.27945|||||||Paired t-test|||Within-group comparisons between the baseline and 3 month data||||0.27945
72575203|NCT02792699|144676504|OTHER||Risk Ratio (RR)|0.878|||||TWO_SIDED|90.0|0.7573|1.0179||||||Risk ratio (ABP 798/ABP 798 versus Rituximab \[EU\]/Rituximab \[EU\]) at week 12, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||1.0179|0.7573|
72575204|NCT02792699|144676504|OTHER||Risk Difference (RD)|-0.0794|||||TWO_SIDED|90.0|-0.1834|0.0247||||||Risk difference (ABP 798/ABP 798 - Rituximab \[EU\]/Rituximab \[EU\]) at week 12, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||0.0247|-0.1834|
72575205|NCT02792699|144676504|OTHER||Risk Ratio (RR)|1.0426|||||TWO_SIDED|90.0|0.877|1.2394||||||Risk ratio (ABP 798/ABP 798 versus Rituximab \[US\]/ABP 798\]) at week 12, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||1.2394|0.8770|
72575206|NCT02792699|144676504|OTHER||Risk Difference (RD)|0.0348|||||TWO_SIDED|90.0|-0.0758|0.1454||||||Risk difference (ABP 798/ABP 798 - Rituximab \[US\]/ABP 798) at week 12, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||0.1454|-0.0758|
72538648|NCT01856686|144606654|SUPERIORITY_OR_OTHER_LEGACY|||||||0.19739|||||||Paired t-test|||Within-group comparisons between the baseline and 3 month data||||0.19739
72538649|NCT01856686|144606655|SUPERIORITY_OR_OTHER_LEGACY|||||||0.50964|||||||ANCOVA|||Between-Group Comparison||||0.50964
72538650|NCT01856686|144606655|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0071|||||||Paired t-test|||Within-group comparisons between the baseline and 3 month data||||0.00710
72538651|NCT01856686|144606655|SUPERIORITY_OR_OTHER_LEGACY|||||||0.00595|||||||Paired t-test|||Within-group comparisons between the baseline and 3 month data||||0.00595
72538652|NCT01856686|144606656|SUPERIORITY_OR_OTHER_LEGACY|||||||0.48336|||||||ANCOVA|||Between-Group Comparison||||0.48336
72538653|NCT01856686|144606656|SUPERIORITY_OR_OTHER_LEGACY|||||||0.08739|||||||Paired t-test|||Within-group comparisons between the baseline and 3 month data||||0.08739
72538654|NCT01856686|144606656|SUPERIORITY_OR_OTHER_LEGACY|||||||0.37046|||||||Paired t-test|||Within-group comparisons between the baseline and 3 month data||||0.37046
72538655|NCT01856686|144606658|SUPERIORITY_OR_OTHER_LEGACY|||||||0.45013|||||||ANCOVA|||Between-Group Comparison||||0.45013
72538656|NCT01856686|144606658|SUPERIORITY_OR_OTHER_LEGACY|||||||0.17374|||||||Paired t-test|||Within-group comparisons between the baseline and 3 month data||||0.17374
72538657|NCT01856686|144606658|SUPERIORITY_OR_OTHER_LEGACY|||||||0.07548|||||||Paired t-test|||Within-group comparisons between the baseline and 3 month data||||0.07548
72538658|NCT01856686|144606659|SUPERIORITY_OR_OTHER_LEGACY|||||||0.23226|||||||ANCOVA|||Between-Group Comparison||||0.23226
72538659|NCT01856686|144606659|SUPERIORITY_OR_OTHER_LEGACY|||||||0.08812|||||||Paired t-test|||Within-group comparisons between the baseline and 3 month data||||0.08812
72538660|NCT01856686|144606659|SUPERIORITY_OR_OTHER_LEGACY|||||||0.00776|||||||Pairedt-test|||Within-group comparisons between the baseline and 3 month data||||0.00776
72538661|NCT01856686|144606660|SUPERIORITY_OR_OTHER_LEGACY|||||||0.90843|||||||ANCOVA|||Between-Group Comparison||||0.90843
72538662|NCT01856686|144606660|SUPERIORITY_OR_OTHER_LEGACY|||||||0.00413|||||||Paired t-test|||Within-group comparisons between the baseline and 3 month data||||0.00413
72538663|NCT01856686|144606660|SUPERIORITY_OR_OTHER_LEGACY|||||||0.00775|||||||Paired t-test|||Within-group comparisons between the baseline and 3 month data||||0.00775
72538664|NCT03349437|144606722|SUPERIORITY|||||||0.02||||||This p-value is in reference to the total Modified 6MWT Distance|Wilcoxon Signed Rank|||||||0.02
72538665|NCT01461369|144606723|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-11.68|STANDARD_ERROR_OF_MEAN|3.806||0.0024|TWO_SIDED|95.0|-19.17|-4.19|||Mixed Models Analysis|||||-4.19|-19.17|0.0024
72575207|NCT02792699|144676504|OTHER||Risk Ratio (RR)|1.0102|||||TWO_SIDED|90.0|0.8743|1.1671||||||Risk ratio (ABP 798/ABP 798 versus Rituximab \[EU\]/Rituximab \[EU\]) at week 24, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||1.1671|0.8743|
72538666|NCT01461369|144606723|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-6.58|STANDARD_ERROR_OF_MEAN|3.739||0.0795|TWO_SIDED|95.0|-13.94|0.78|||Mixed Models Analysis|||||0.78|-13.94|0.0795
72538667|NCT01461369|144606724|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-15.82|STANDARD_ERROR_OF_MEAN|3.552|<|0.0001|TWO_SIDED|95.0|-22.82|-8.83|||Mixed Models Analysis|||||-8.83|-22.82|<0.0001
72538668|NCT01461369|144606724|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-9.8|STANDARD_ERROR_OF_MEAN|3.481||0.0052|TWO_SIDED|95.0|-16.66|-2.95|||Mixed Models Analysis|||||-2.95|-16.66|0.0052
72538669|NCT01461369|144606725|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-12.43|STANDARD_ERROR_OF_MEAN|3.776||0.0011|TWO_SIDED|95.0|-19.87|-4.99|||Mixed Models Analysis|||||-4.99|-19.87|0.0011
72538670|NCT01461369|144606725|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-5.56|STANDARD_ERROR_OF_MEAN|3.707||0.1349|TWO_SIDED|95.0|-12.86|1.74|||Mixed Models Analysis|||||1.74|-12.86|0.1349
72538671|NCT01461369|144606726|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-13.24|STANDARD_ERROR_OF_MEAN|3.377||0.0001|TWO_SIDED|95.0|-19.89|-6.59|||ANCOVA|||||-6.59|-19.89|0.0001
72538672|NCT01461369|144606726|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-7.48|STANDARD_ERROR_OF_MEAN|3.313||0.0248|TWO_SIDED|95.0|-14.0|-0.96|||ANCOVA|||||-0.96|-14.00|0.0248
72538673|NCT01461369|144606727|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-12.63|STANDARD_ERROR_OF_MEAN|3.396||0.0002|TWO_SIDED|95.0|-19.32|-5.94|||ANCOVA|||||-5.94|-19.32|0.0002
72538674|NCT01461369|144606727|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-7.03|STANDARD_ERROR_OF_MEAN|3.339||0.0363|TWO_SIDED|95.0|-13.6|-0.45|||ANCOVA|||||-0.45|-13.60|0.0363
72538675|NCT01461369|144606728|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-10.38|STANDARD_ERROR_OF_MEAN|3.441||0.0028|TWO_SIDED|95.0|-17.16|-3.6|||ANCOVA|||||-3.60|-17.16|0.0028
72538676|NCT01461369|144606728|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-5.46|STANDARD_ERROR_OF_MEAN|3.385||0.1081|TWO_SIDED|95.0|-12.13|1.21|||ANCOVA|||||1.21|-12.13|0.1081
72538677|NCT04604496|144606729|OTHER|The adjusted ratio and 90% confidence interval from the analysis of variance (ANOVA) model were expressed as percentages.|Ratio of adjusted geometric means|133.17|||||TWO_SIDED|90.0|81.97|216.37||||||Test: the mild hepatic impairment group; Reference: the without hepatic impairment group||216.37|81.97|
72538678|NCT04604496|144606729|OTHER|The adjusted ratio and 90% confidence interval from the analysis of variance (ANOVA) model were expressed as percentages.|Ratio of adjusted geometric means|219.98|||||TWO_SIDED|90.0|135.39|357.41||||||Test: the moderate hepatic impairment Group; Reference: the without hepatic impairment group||357.41|135.39|
72575208|NCT02792699|144676504|OTHER||Risk Difference (RD)|0.0199|||||TWO_SIDED|90.0|-0.0835|0.1234||||||Risk difference (ABP 798/ABP 798 - Rituximab \[EU\]/Rituximab \[EU\]) at week 24, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||0.1234|-0.0835|
72575209|NCT02792699|144676504|OTHER||Risk Ratio (RR)|1.0793|||||TWO_SIDED|90.0|0.9244|1.2601||||||Risk ratio (ABP 798/ABP 798 versus Rituximab \[US\]/ABP 798\]) at week 24, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||1.2601|0.9244|
72538679|NCT04604496|144606729|OTHER|The adjusted ratio and 90% confidence interval from the analysis of variance (ANOVA) model were expressed as percentages.|Ratio of adjusted geometric means|334.21|||||TWO_SIDED|90.0|205.7|543.0||||||Test: the severe hepatic impairment group; Reference: the without hepatic impairment group||543.00|205.70|
72538680|NCT04604496|144606730|OTHER|The adjusted ratio and 90% confidence interval from the analysis of variance (ANOVA) model were expressed as percentages.|Ratio of adjusted geometric means|122.7|||||TWO_SIDED|90.0|61.33|245.49||||||Test: the mild hepatic impairment group; Reference: the without hepatic impairment group||245.49|61.33|
72538681|NCT04604496|144606730|OTHER|The adjusted ratio and 90% confidence interval from the analysis of variance (ANOVA) model were expressed as percentages.|Ratio of adjusted geometric means|282.73|||||TWO_SIDED|90.0|141.32|565.66||||||Test: the moderate hepatic impairment Group; Reference: the without hepatic impairment group||565.66|141.32|
72538682|NCT04604496|144606730|OTHER|The adjusted ratio and 90% confidence interval from the analysis of variance (ANOVA) model were expressed as percentages.|Ratio of adjusted geometric means|640.78|||||TWO_SIDED|90.0|320.27|1282.0||||||Test: the severe hepatic impairment group; Reference: the without hepatic impairment group||1282.00|320.27|
72538683|NCT04604496|144606731|OTHER|The adjusted ratio and 90% confidence interval from the analysis of variance (ANOVA) model were expressed as percentages.|Ratio of adjusted geometric means|122.89|||||TWO_SIDED|90.0|61.51|245.51||||||Test: the mild hepatic impairment group; Reference: the without hepatic impairment group||245.51|61.51|
72538684|NCT04604496|144606731|OTHER|The adjusted ratio and 90% confidence interval from the analysis of variance (ANOVA) model were expressed as percentages.|Ratio of adjusted geometric means|283.88|||||TWO_SIDED|90.0|142.1|567.13||||||Test: the moderate hepatic impairment Group; Reference: the without hepatic impairment group||567.13|142.10|
72538685|NCT04604496|144606731|OTHER|The adjusted ratio and 90% confidence interval from the analysis of variance (ANOVA) model were expressed as percentages.|Ratio of adjusted geometric means|636.32|||||TWO_SIDED|90.0|318.51|1271.24||||||Test: the severe hepatic impairment group; Reference: the without hepatic impairment group||1271.24|318.51|
72538686|NCT04604496|144606732|OTHER|The adjusted ratio and 90% confidence interval from the analysis of variance (ANOVA) model were expressed as percentages.|Ratio of adjusted geometric means|85.19|||||TWO_SIDED|90.0|63.6|114.1||||||Test: the mild hepatic impairment group; Reference: the without hepatic impairment group||114.10|63.60|
72538687|NCT04604496|144606732|OTHER|The adjusted ratio and 90% confidence interval from the analysis of variance (ANOVA) model were expressed as percentages.|Ratio of adjusted geometric means|96.37|||||TWO_SIDED|90.0|71.95|129.07||||||Test: the moderate hepatic impairment Group; Reference: the without hepatic impairment group||129.07|71.95|
72538688|NCT04604496|144606732|OTHER|The adjusted ratio and 90% confidence interval from the analysis of variance (ANOVA) model were expressed as percentages.|Ratio of adjusted geometric means|135.2|||||TWO_SIDED|90.0|100.94|181.1||||||Test: the severe hepatic impairment group; Reference: the without hepatic impairment group||181.10|100.94|
72538689|NCT01563029|144606771|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.0|||<|0.001|TWO_SIDED|95.0|9.6|22.4|||ANCOVA|Gate-keeper analysis||||22.4|9.6|<0.001
72538690|NCT01563029|144606771|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.5|||<|0.001|TWO_SIDED|95.0|5.1|19.8|||ANCOVA||Inference for FF 100 μg versus (vs) placebo and FF 50 ug versus placebo was dependent upon statistical significance (SS) having first been achieved for the average of the higher two doses of FF (FF 100 ug and 50 ug ) versus placebo comparison.|||19.8|5.1|<0.001
72538691|NCT01563029|144606771|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|19.5|||<|0.001|TWO_SIDED|95.0|12.1|26.9|||ANCOVA||Inference for FF 100 µg versus (vs) placebo and FF 50 ug versus placebo was dependent upon statistical significance (SS) having first been achieved for the average of the higher two doses of FF (FF 100 ug and 50 ug ) versus placebo comparsion.|||26.9|12.1|<0.001
72538692|NCT01563029|144606771|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|18.6|||<|0.001|TWO_SIDED|95.0|11.3|26.0|||ANCOVA||Inference for FF 25 ug versus placebo was dependent upon statistical significance (SS) having first been achieved for both the FF 100 ug versus placebo comparison and the FF 50 ug versus placebocomparison.|||26.0|11.3|<0.001
72575210|NCT02792699|144676504|OTHER||Risk Difference (RD)|0.0561|||||TWO_SIDED|90.0|-0.0493|0.1615||||||Risk difference (ABP 798/ABP 798 - Rituximab \[US\]/ABP 798) at week 24, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||0.1615|-0.0493|
72575211|NCT02792699|144676504|OTHER||Risk Ratio (RR)|0.8848|||||TWO_SIDED|90.0|0.7759|1.0091||||||Risk ratio (ABP 798/ABP 798 versus Rituximab \[EU\]/Rituximab \[EU\]) at week 40, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||1.0091|0.7759|
72575212|NCT02792699|144676504|OTHER||Risk Difference (RD)|-0.0776|||||TWO_SIDED|90.0|-0.1789|0.0237||||||Risk difference (ABP 798/ABP 798 - Rituximab \[EU\]/Rituximab \[EU\]) at week 40, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||0.0237|-0.1789|
72575213|NCT02792699|144676504|OTHER||Risk Ratio (RR)|0.9982|||||TWO_SIDED|90.0|0.8585|1.1605||||||Risk ratio (ABP 798/ABP 798 versus Rituximab \[US\]/ABP 798\]) at week 40, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||1.1605|0.8585|
72538693|NCT01563029|144606771|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|14.0|||<|0.001|TWO_SIDED|95.0|6.7|21.4|||ANCOVA|||||21.4|6.7|<0.001
72538694|NCT01563029|144606772|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.126|||<|0.001|TWO_SIDED|95.0|0.051|0.201|||ANCOVA|||||0.201|0.051|<0.001
72538695|NCT01563029|144606772|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.022||||0.551|TWO_SIDED|95.0|-0.05|0.094|||ANCOVA|||||0.094|-0.050|0.551
72538696|NCT01563029|144606772|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.033||||0.379|TWO_SIDED|95.0|-0.041|0.108|||ANCOVA|||||0.108|-0.041|0.379
72538697|NCT01563029|144606772|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.064||||0.089|TWO_SIDED|95.0|-0.01|0.137|||ANCOVA|||||0.137|-0.010|0.089
72538698|NCT01563029|144606773|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.4||||0.05|TWO_SIDED|95.0|0.0|16.9|||ANCOVA|||||16.9|0.0|0.050
72575214|NCT02792699|144676504|OTHER||Risk Difference (RD)|0.0008|||||TWO_SIDED|90.0|-0.1038|0.1054||||||Risk difference (ABP 798/ABP 798 - Rituximab \[US\]/ABP 798) at week 40, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||0.1054|-0.1038|
72575215|NCT02792699|144676504|OTHER||Risk Ratio (RR)|0.7862|||||TWO_SIDED|90.0|0.6722|0.9196||||||Risk ratio (ABP 798/ABP 798 versus Rituximab \[EU\]/Rituximab \[EU\]) at week 48, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||0.9196|0.6722|
72538699|NCT01563029|144606773|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.8||||0.023|TWO_SIDED|95.0|1.3|18.2|||ANCOVA|||||18.2|1.3|0.023
72538700|NCT01563029|144606773|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.2||||0.004|TWO_SIDED|95.0|3.8|20.5|||ANCOVA|||||20.5|3.8|0.004
72538701|NCT01563029|144606773|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.2||||0.143|TWO_SIDED|95.0|-2.1|14.6|||ANCOVA|||||14.6|-2.1|0.143
72538702|NCT01563029|144606774|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.2||||0.005|TWO_SIDED|95.0|3.4|19.0|||ANCOVA|||||19.0|3.4|0.005
72538703|NCT01563029|144606774|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.4|||<|0.001|TWO_SIDED|95.0|5.7|21.1|||ANCOVA|||||21.1|5.7|<0.001
72538704|NCT01563029|144606774|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.4|||<|0.033|TWO_SIDED|95.0|0.7|16.1|||ANCOVA|||||16.1|0.7|<0.033
72538705|NCT01563029|144606774|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.0||||0.042|TWO_SIDED|95.0|0.3|15.7|||ANCOVA|||||15.7|0.3|0.042
72538706|NCT01563029|144606775|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.2||||0.037|TWO_SIDED|95.0|0.7|21.7|||ANCOVA|||||21.7|0.7|0.037
72538707|NCT01563029|144606775|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.1||||0.014|TWO_SIDED|95.0|2.6|23.6|||ANCOVA|||||23.6|2.6|0.014
72538708|NCT01563029|144606775|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.9||||0.266|TWO_SIDED|95.0|-4.5|16.3|||ANCOVA|||||16.3|-4.5|0.266
72538709|NCT01563029|144606775|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.2||||0.242|TWO_SIDED|95.0|-4.2|16.6|||ANCOVA|||||16.6|-4.2|0.242
72538710|NCT01563029|144606776|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|20.6|||<|0.001|TWO_SIDED|95.0|10.0|31.3|||ANCOVA|||||31.3|10.0|<0.001
72538711|NCT01563029|144606776|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|17.9||||0.001|TWO_SIDED|95.0|7.2|28.6|||ANCOVA|||||28.6|7.2|0.001
72538712|NCT01563029|144606776|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.5||||0.033|TWO_SIDED|95.0|0.9|22.1|||ANCOVA|||||22.1|0.9|0.033
72538713|NCT01563029|144606776|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.7||||0.002|TWO_SIDED|95.0|6.0|27.3|||ANCOVA|||||27.3|6.0|0.002
72538714|NCT01563029|144606777|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.1||||0.619|TWO_SIDED|95.0|-6.1|10.2|||ANCOVA|||||10.2|-6.1|0.619
72538715|NCT01563029|144606777|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.8||||0.161||95.0|-2.3|13.9|||ANCOVA|||||13.9|-2.3|0.161
72538716|NCT01563029|144606777|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.9||||0.34|TWO_SIDED|95.0|-4.1|12.0|||ANCOVA|||||12.0|-4.1|0.340
72538717|NCT01563029|144606777|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.0||||0.459|TWO_SIDED|95.0|-5.0|11.1|||ANCOVA|||||11.1|-5.0|0.459
72538718|NCT01563029|144606778|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Fisher Exact|||||||<0.001
72538719|NCT01563029|144606778|SUPERIORITY_OR_OTHER|||||||0.006||95.0|||||Fisher Exact|||||||0.006
72538720|NCT01563029|144606778|SUPERIORITY_OR_OTHER|||||||0.003||95.0|||||Fisher Exact|||||||0.003
72538721|NCT01563029|144606778|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Fisher Exact|||||||<0.001
72538722|NCT04854707|144606789|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
72538723|NCT04854707|144606789|OTHER|||||||0.032|||||||Wilcoxon (Mann-Whitney)|||||||0.032
72538724|NCT04854707|144606790|OTHER||Mean Difference (Final Values)|0.017||||0.314|TWO_SIDED|95.0|-0.0161|0.0501|||Chi-squared|z-value = 1||95% Confidence intervals (CIs) of point estimates were calculated using the exact binominal distribution (Clopper-Pearson method) for proportions||0.0501|-0.0161|0.314
72538725|NCT04854707|144606790|OTHER||Mean Difference (Final Values)|0.0207||||0.482|TWO_SIDED|95.0|-0.0369|0.0782|||Chi-squared|||95% Confidence intervals (CIs) of point estimates were calculated using the exact binominal distribution (Clopper-Pearson method) for proportions||0.0782|-0.0369|0.482
72538726|NCT04854707|144606791|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
72538727|NCT04854707|144606791|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
72538728|NCT04854707|144606792|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
72538729|NCT04854707|144606793|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
72538730|NCT04854707|144606793|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
72538731|NCT00203931|144606800|SUPERIORITY_OR_OTHER|||||||0.11|||||||Log Rank|||||||0.11
72538732|NCT00203931|144606801|SUPERIORITY_OR_OTHER|||||||0.91|||||||Wilcoxon-Gehan test|||||||0.91
72538733|NCT00203931|144606802|SUPERIORITY_OR_OTHER|||||||0.24|||||||Fisher Exact|||||||0.24
72538734|NCT00203931|144606803|SUPERIORITY_OR_OTHER|||||||0.046|||||||Wilcoxon-Gehan test|||||||0.046
72538735|NCT00203931|144606804|SUPERIORITY_OR_OTHER|||||||0.029|||||||Log Rank|||||||0.029
72538736|NCT02426125|144606805|SUPERIORITY||Hazard Ratio (HR)|0.757||||0.0118|TWO_SIDED|95.0|0.607|0.943||Stratified|Log Rank||Stratified|||0.943|0.607|0.0118
72538737|NCT02426125|144606806|SUPERIORITY||Hazard Ratio (HR)|0.887||||0.2461|TWO_SIDED|95.0|0.724|1.086||Stratified|Log Rank||Stratified|||1.086|0.724|0.2461
72538738|NCT02426125|144606809|SUPERIORITY||Hazard Ratio (HR)|0.74||||0.189|TWO_SIDED|95.0|0.473|1.158|||Log Rank|||||1.158|0.473|0.189
72538739|NCT02426125|144606810|SUPERIORITY||Hazard Ratio (HR)|0.879||||0.357|TWO_SIDED|95.0|0.663|1.167||Stratified|Log Rank||Stratified|Global health status/QoL||1.167|0.663|0.357
72538740|NCT03701516|144606829|NON_INFERIORITY|Non-inferiority will be established if the lower bound of the credible interval of the mean difference between Test and Control is greater than -5.|Posterior Mean Difference|-0.38|STANDARD_DEVIATION|1.781|||TWO_SIDED|98.0|-4.53|3.85|||Bayesian repeated measurement model|Results were reported as regression coefficient mean estimates with credible intervals (CrI)|Mean difference was calculated as Test - Control|||3.85|-4.53|
72538741|NCT03701516|144606830|NON_INFERIORITY|Non-inferiority will be established if the lower bound of the credible interval of the mean difference between Test and Control is greater than -5.|Posterior Mean Difference|-2.34|STANDARD_DEVIATION|1.263|||TWO_SIDED|98.0|-5.36|0.61|||Bayesian repeated measurement model|Results were reported as regression coefficient mean estimates with credible intervals (CrI)|Mean difference was calculated as Test - Control|||0.61|-5.36|
72538742|NCT03701516|144606831|NON_INFERIORITY|Non-inferiority will be established if the lower bound of the credible interval of the mean difference between Test and Control is greater than -1.|Posterior Mean Difference|-0.06|STANDARD_DEVIATION|0.083|||TWO_SIDED|95.0|-0.22|0.1|||Bayesian repeated measurement model|Results were reported as regression coefficient mean estimates with credible intervals (CrI)|Mean difference was calculated as Test - Control|||0.10|-0.22|
72538743|NCT03701516|144606832|NON_INFERIORITY|Non-inferiority will be established if the upper bound of the credible interval of the mean difference between Test and Control is less than 0.05.|Posterior Mean Difference|0.001|STANDARD_DEVIATION|0.0028|||TWO_SIDED|95.0|-0.005|0.006|||Bayesian repeated measurement random-eff|Results were reported as regression coefficient mean estimates with credible intervals (CrI)|Mean difference was calculated as Test - Control|||0.006|-0.005|
72538744|NCT03701516|144606833|NON_INFERIORITY|Non-inferiority will be established if the upper bound of the credible interval of the mean difference between Test and Control is less than 0.05.|Posterior Mean Difference|-0.003|STANDARD_DEVIATION|0.0029|||TWO_SIDED|95.0|-0.009|0.002|||Bayesian repeated measurement model|Results were reported as regression coefficient mean estimates with credible intervals (CrI)|Mean difference was calculated as Test - Control|||0.002|-0.009|
72538745|NCT00609115|144606834|SUPERIORITY||Effect size|0.65||||0.01|TWO_SIDED|97.5|||||ANCOVA|||||||0.010
72538746|NCT00609115|144606834|SUPERIORITY||Effect|0.71||||0.003|TWO_SIDED|95.0|||||ANCOVA|||||||0.003
72538747|NCT00609115|144606835|SUPERIORITY||Effect Size|0.0||||1|TWO_SIDED|95.0||||The reported p-value was calculated.|ANCOVA|||||||1.00
72538748|NCT00609115|144606835|SUPERIORITY||Effect Size|-0.29||||0.06|TWO_SIDED|95.0|||||ANCOVA|||||||0.06
72538749|NCT00609115|144606836|SUPERIORITY||Effect Size|0.33||||0.17|TWO_SIDED|95.0|||||ANCOVA|||||||0.17
72538750|NCT00609115|144606836|SUPERIORITY||Effect Size|0.4||||0.17|TWO_SIDED|95.0|||||ANCOVA|||||||0.17
72538751|NCT00609115|144606837|SUPERIORITY||Effect Size|0.05||||0.83|TWO_SIDED|95.0|||||ANCOVA|||||||0.83
72538752|NCT00609115|144606837|SUPERIORITY||Effect Size|-0.27||||0.83|TWO_SIDED|95.0|||||ANCOVA|||||||0.83
72538753|NCT00609115|144606838|SUPERIORITY||Effect Size|0.25||||0.28|TWO_SIDED|95.0|||||ANCOVA|||||||0.28
72538754|NCT00609115|144606838|SUPERIORITY||Effect Size|0.38||||0.09|TWO_SIDED|95.0|||||ANCOVA|||||||0.09
72538755|NCT00609115|144606839|SUPERIORITY||Effect Size|0.23||||0.18|TWO_SIDED|95.0|||||ANCOVA|||||||0.18
72538756|NCT00609115|144606839|SUPERIORITY||Effect Size|0.37||||0.1|TWO_SIDED|95.0|||||ANCOVA|||||||0.10
72538757|NCT00609115|144606840|SUPERIORITY||Effect Size|0.18||||0.45|TWO_SIDED|95.0|||||ANCOVA|||||||0.45
72538758|NCT00609115|144606840|SUPERIORITY||Effect Size|0.71||||0.003|TWO_SIDED|95.0|||||ANCOVA|||||||0.003
72538759|NCT00609115|144606841|SUPERIORITY||Effect Size|-0.17||||0.47|TWO_SIDED|95.0|||||ANCOVA|||||||0.47
72538760|NCT00609115|144606841|SUPERIORITY||Effect Size|0.77||||0.015|TWO_SIDED|95.0|||||ANCOVA|||||||0.015
72538761|NCT00609115|144606842|SUPERIORITY||Effect Size|0.48||||0.05|TWO_SIDED|95.0|||||ANCOVA|||||||0.05
72538762|NCT00609115|144606842|SUPERIORITY||Effect Size|0.56||||0.002|TWO_SIDED|95.0|||||ANCOVA|||||||0.002
72538763|NCT00609115|144606843|SUPERIORITY||Effect Size|0.26||||0.27|TWO_SIDED|95.0|||||ANCOVA|||||||0.27
72409659|NCT00807092|144327719|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.178|STANDARD_ERROR_OF_MEAN|1.0||0.2412||95.0|-0.802|3.157||A statistical significant threshold p\<0.05|ANCOVA|Treatment and strata as factors; corresponding baseline (week 0) value of mean IAUC(0-4h) as covariate (breakfast/lunch/dinner)|Breakfast|"Null hypothesis and alternative hypothesis for breakfast:~The null hypothesis (H0) was:~H0: Change in mean IAUC(0-4h) of BIAsp 30 for breakfast after 6 weeks of treatment-Change in mean IAUC(0-4h) of BHI 30 for breakfast after 6 weeks of treatment =0 mol\*h/L against the alternative hypothesis(H1): H1: Change in mean IAUC (0-4h) of BIAsp 30 for breakfast after 6 weeks of treatment-Change in mean IAUC(0-4h) of BHI 30 for breakfast after 6 weeks of treatment≠0 mol\*h/L"||3.157|-0.802|0.2412
72409660|NCT00807092|144327719|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.318|STANDARD_ERROR_OF_MEAN|1.216||0.794||95.0|-2.724|2.087||A statistical significant threshold p\<0.05|ANCOVA|Treatment and strata as factors; corresponding baseline (week 0) value of mean IAUC(0-4h) as covariate (breakfast/lunch/dinner)|Lunch|"Null hypothesis and alternative hypothesis for lunch:~The null hypothesis (H0) was:~H0: Change in mean IAUC(0-4h) of BIAsp 30 for lunch after 6 weeks of treatment-Change in mean IAUC(0-4h) of BHI 30 for lunch after 6 weeks of treatment =0 mol\*h/L against the alternative hypothesis(H1): H1: Change in mean IAUC (0-4h) of BIAsp 30 for lunch after 6 weeks of treatment-Change in mean IAUC(0-4h) of BHI 30 for lunch after 6 weeks of treatment≠0 mol\*h/L"||2.087|-2.724|0.794
72409661|NCT00807092|144327719|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.749||||0.3093||95.0|-2.2|0.703||A statistical significant threshold p\<0.05|ANCOVA|Treatment and strata as factors; corresponding baseline (week 0) value of mean IAUC(0-4h) as covariate (breakfast/lunch/dinner)|Dinner|"Null hypothesis and alternative hypothesis for dinner:~The null hypothesis (H0) was:~H0: Change in mean IAUC(0-4h) of BIAsp 30 for dinner after 6 weeks of treatment-Change in mean IAUC(0-4h) of BHI 30 for dinner after 6 weeks of treatment =0 mol\*h/L against the alternative hypothesis(H1): H1: Change in mean IAUC (0-4h) of BIAsp 30 for dinner after 6 weeks of treatment-Change in mean IAUC(0-4h) of BHI 30 for dinner after 6 weeks of treatment≠0 mol\*h/L"||0.703|-2.2|0.3093
72538764|NCT00609115|144606843|SUPERIORITY||Effect Size|0.45||||0.045|TWO_SIDED|95.0|||||ANCOVA|||||||0.045
72538765|NCT02125734|144606844|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.081||||0.0017|TWO_SIDED|95.0|0.031|0.13|||ANCOVA|||||0.130|0.031|0.0017
72538766|NCT02304302|144606896|SUPERIORITY||Mean Difference (Net)|0.34||||0.61|TWO_SIDED|95.0|-0.98|1.67|||Mixed Models Analysis|||||1.67|-0.98|0.61
72538767|NCT02304302|144606897|SUPERIORITY||Mean Difference (Net)|-0.32||||0.57|TWO_SIDED|95.0|-1.43|0.8|||Mixed Models Analysis|||||0.80|-1.43|0.57
72538768|NCT02304302|144606898|SUPERIORITY||Median Difference (Net)|-0.04||||0.91|TWO_SIDED|95.0|-0.74|0.66|||Mixed Models Analysis|||||0.66|-0.74|0.91
72538769|NCT02304302|144606899|SUPERIORITY||Median Difference (Final Values)|-0.5||||0.48|TWO_SIDED|95.0|-1.91|0.91|||Mixed Models Analysis|||||0.91|-1.91|0.48
72538770|NCT02304302|144606900|SUPERIORITY||Mean Difference (Net)|-1.31||||0.5|TWO_SIDED|95.0|-5.14|2.53|||Mixed Models Analysis|||||2.53|-5.14|0.50
72538771|NCT02304302|144606901|SUPERIORITY||Mean Difference (Net)|-0.1||||0.62|TWO_SIDED|95.0|-0.52|0.32|||Mixed Models Analysis|||||0.32|-0.52|0.62
72538772|NCT02304302|144606902|SUPERIORITY||Mean Difference (Net)|2.94||||0.84|TWO_SIDED|95.0|-25.32|31.2|||Mixed Models Analysis|||||31.20|-25.32|0.84
72538773|NCT02304302|144606903|SUPERIORITY||Mean Difference (Net)|-3.04||||0.24|TWO_SIDED|95.0|||||ANOVA|||QTc interval duration was the independent variable, treatment and time were the categorical factors.||||0.24
72538774|NCT02304302|144606904|SUPERIORITY||Mean Difference (Net)|1.91||||0.28|TWO_SIDED|95.0|-1.57|5.39|||Mixed Models Analysis|||||5.39|-1.57|0.28
72538775|NCT02304302|144606905|SUPERIORITY||Mean Difference (Net)|0.4||||0.51|TWO_SIDED|95.0|-0.8|1.61|||Mixed Models Analysis|||||1.61|-0.80|0.51
72575216|NCT02792699|144676504|OTHER||Risk Difference (RD)|-0.2004|||||TWO_SIDED|90.0|-0.3066|-0.0941||||||Risk difference (ABP 798/ABP 798 - Rituximab \[EU\]/Rituximab \[EU\]) at week 48, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||-0.0941|-0.3066|
72538776|NCT02304302|144606906|SUPERIORITY||Mean Difference (Net)|1.17||||0.63|TWO_SIDED|95.0|-3.6|5.94|||Mixed Models Analysis|||||5.94|-3.6|0.63
72538777|NCT02304302|144606907|SUPERIORITY||Mean Difference (Net)|-3.65||||0.17|TWO_SIDED|95.0|-8.91|1.61|||Mixed Models Analysis|||||1.61|-8.91|0.17
72538778|NCT02508649|144606911|SUPERIORITY||Treatment difference|0.55||||0.3015|TWO_SIDED|95.0|-1.34|2.43|||van Elteren test|||The primary endpoint was analyzed using a van Elteren test. The analysis included a test of superiority using a two-sided 5% significance level.||2.43|-1.34|0.3015
72538779|NCT02508649|144606912|SUPERIORITY||Odds Ratio (OR)|1.049||||0.7694|TWO_SIDED|95.0|0.762|1.445|||Regression, Logistic||An odds ratio \< 1 in proportion of subjects dying indicates lower mortality in the selepressin group.|Mortality was analyzed using a logistic regression model with the individual sequential organ failure assessment (SOFA) scores and age as covariates and treatment arm as factor.||1.445|0.762|0.7694
72538780|NCT02508649|144606913|SUPERIORITY||Treatment difference|0.29||||0.8458|TWO_SIDED|95.0|-2.07|2.65|||van Elteren test|||This endpoint was analyzed using a van Elteren test. The analysis was a test of superiority using a two-sided 5% significance level.||2.65|-2.07|0.8458
72538781|NCT02508649|144606914|SUPERIORITY||Treatment difference|0.49||||0.4124|TWO_SIDED|95.0|-1.22|2.19|||van Elteren test|||This endpoint was analyzed using a van Elteren test. The analysis was a test of superiority using a two-sided 5% significance level.||2.19|-1.22|0.4124
72538782|NCT02508649|144606921|OTHER||Treatment difference|-0.51||||0.2009|TWO_SIDED|95.0|-1.3|0.27|||ANCOVA|||Overall score using a modified version of the SOFA on Day 1||0.27|-1.30|0.2009
72538783|NCT02508649|144606921|OTHER||Treatment difference|0.11||||0.7894|TWO_SIDED|95.0|-0.68|0.9|||ANCOVA|||Overall score using a modified version of the SOFA on Day 3||0.90|-0.68|0.7894
72538784|NCT02508649|144606921|OTHER||Treatment difference|0.55||||0.1888|TWO_SIDED|95.0|-0.27|1.37|||ANCOVA|||Overall score using a modified version of the SOFA on Day 7||1.37|-0.27|0.1888
72538785|NCT02508649|144606921|OTHER||Treatment difference|-0.08||||0.2997|TWO_SIDED|95.0|-0.24|0.07|||ANCOVA|||Individual organ (respiratory) score using a modified version of the SOFA on Day 1||0.07|-0.24|0.2997
72538786|NCT02508649|144606921|OTHER||Treatment difference|-0.03||||0.6796|TWO_SIDED|95.0|-0.19|0.12|||ANCOVA|||Individual organ (respiratory) score using a modified version of the SOFA on Day 3||0.12|-0.19|0.6796
72409662|NCT00807092|144327720|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.448|STANDARD_ERROR_OF_MEAN|0.261||0.0891||95.0|-0.069|0.964||A statistical significant threshold p\<0.05|ANCOVA|Treatment and strata as factors; baseline (week 0) value of mean FBG as covariate||"The null hypothesis (H0) was:~H0: Change in mean FBG of BIAsp 30 after 6 weeks of treatment-Change in mean FBG of BHI 30 after 6 weeks of treatment =0 mmol/L against the alternative hypothesis(H1): H1: Change in mean FBG of BIAsp 30 after 6 weeks of treatment-Change in mean FBG of BHI 30 after 6 weeks of treatment≠0 mmol/L"||0.964|-0.069|0.0891
72538787|NCT02508649|144606921|OTHER||Treatment difference|0.03||||0.7467|TWO_SIDED|95.0|-0.14|0.19|||ANCOVA|||Individual organ (respiratory) score using a modified version of the SOFA on Day 7||0.19|-0.14|0.7467
72538788|NCT02508649|144606921|OTHER||Treatment difference|-0.42||||0.0003|TWO_SIDED|95.0|-0.65|-0.19|||ANCOVA|||Individual organ (cardiovascular) score using a modified version of the SOFA on Day 1||-0.19|-0.65|0.0003
72538789|NCT02508649|144606921|OTHER||Treatment difference|-0.25||||0.0349|TWO_SIDED|95.0|-0.49|-0.02|||ANCOVA|||Individual organ (cardiovascular) score using a modified version of the SOFA on Day 3||-0.02|-0.49|0.0349
72538790|NCT02508649|144606921|OTHER||Treatment difference|-0.14||||0.2787|TWO_SIDED|95.0|-0.39|0.11|||ANCOVA|||Individual organ (cardiovascular) score using a modified version of the SOFA on Day 7||0.11|-0.39|0.2787
72538791|NCT02508649|144606921|OTHER||Treatment difference|-0.05||||0.6476|TWO_SIDED|95.0|-0.26|0.16|||ANCOVA|||Individual organ (renal) score using a modified version of the SOFA on Day 1||0.16|-0.26|0.6476
72538792|NCT02508649|144606921|OTHER||Treatment difference|0.08||||0.4313|TWO_SIDED|95.0|-0.13|0.29|||ANCOVA|||Individual organ (renal) score using a modified version of the SOFA on Day 3||0.29|-0.13|0.4313
72538793|NCT02508649|144606921|OTHER||Treatment difference|0.17||||0.1334|TWO_SIDED|95.0|-0.05|0.39|||ANCOVA|||Individual organ (renal) score using a modified version of the SOFA on Day 7||0.39|-0.05|0.1334
72538794|NCT02508649|144606921|OTHER||Treatment difference|0.12||||0.2126|TWO_SIDED|95.0|-0.07|0.3|||ANCOVA|||Individual organ (coagulation) score using a modified version of the SOFA on Day 1||0.30|-0.07|0.2126
72538795|NCT02508649|144606921|OTHER||Treatment Difference|0.23||||0.0174|TWO_SIDED|95.0|0.04|0.41|||ANCOVA|||Individual organ (coagulation) score using a modified version of the SOFA on Day 3||0.41|0.04|0.0174
72538796|NCT02508649|144606921|OTHER||Treatment difference|0.23||||0.0194|TWO_SIDED|95.0|0.04|0.43|||ANCOVA|||Individual organ (coagulation) score using a modified version of the SOFA on Day 7||0.43|0.04|0.0194
72538797|NCT02508649|144606921|OTHER||Treatment difference|-0.15||||0.1284|TWO_SIDED|95.0|-0.35|0.04|||ANCOVA|||Individual organ (liver) score using a modified version of the SOFA on Day 1||0.04|-0.35|0.1284
72538798|NCT02508649|144606921|OTHER||Treatment difference|-0.05||||0.6542|TWO_SIDED|95.0|-0.25|0.15|||ANCOVA|||Individual organ (liver) score using a modified version of the SOFA on Day 3||0.15|-0.25|0.6542
72575217|NCT02792699|144676504|OTHER||Risk Ratio (RR)|0.8804|||||TWO_SIDED|90.0|0.7587|1.0215||||||Risk ratio (ABP 798/ABP 798 versus Rituximab \[US\]/ABP 798\]) at week 48, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||1.0215|0.7587|
72575218|NCT02792699|144676504|OTHER||Risk Difference (RD)|-0.1037|||||TWO_SIDED|90.0|-0.2066|-0.0007||||||Risk difference (ABP 798/ABP 798 - Rituximab \[US\]/ABP 798) at week 48, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||-0.0007|-0.2066|
72538799|NCT02508649|144606921|OTHER||Treatment difference|0.17||||0.1079|TWO_SIDED|95.0|-0.04|0.38|||ANCOVA|||Individual organ (liver) score using a modified version of the SOFA on Day 7||0.38|-0.04|0.1079
72538800|NCT02508649|144606922|OTHER||Odds Ratio (OR)|1.4||||0.063|TWO_SIDED|95.0|0.98|2.0|||Regression, Logistic||Odds ratio is equal to Selepressin pooled/Placebo.|Percentage of subjects with new organ dysfunction up to Day 7||2.00|0.98|0.0630
72538801|NCT02508649|144606922|OTHER||Odds Ratio (OR)|1.28||||0.1875|TWO_SIDED|95.0|0.89|1.86|||Regression, Logistic||Odds ratio is equal to Selepressin pooled/Placebo.|Percentage of subjects with new organ dysfunction up to Day 30||1.86|0.89|0.1875
72538802|NCT02508649|144606922|OTHER||Odds Ratio (OR)|1.14||||0.4382|TWO_SIDED|95.0|0.82|1.58|||Regression, Logistic||Odds ratio is equal to Selepressin pooled/Placebo.|Percentage of subjects with new organ failure up to Day 7||1.58|0.82|0.4382
72538803|NCT02508649|144606922|OTHER||Odds Ratio (OR)|1.01||||0.9529|TWO_SIDED|95.0|0.73|1.39|||Regression, Logistic||Odds ratio is equal to Selepressin pooled/Placebo.|Percentage of subjects with new organ failure up to Day 30||1.39|0.73|0.9529
72538804|NCT00417859|144606937|SUPERIORITY|||||||0.05|||||||Wilcoxon (Mann-Whitney)|||FB group was designated the control group. We determined a sample size based in clinical criteria. Using an α of 0.05 and β of 0.8, the required sample size was calculated to be 24 patients in each group to achieve a power of 80%. Descriptive analysis was completed on demographic information and clinical and radiological outcomes. Nonparametric tests (Wilcoxon's signed ranks or rank sum tests) were used for comparison of scores. The chi-squared test was used for dichotomous variables.||||0.05
72538805|NCT03594175|144606949|SUPERIORITY||Mean difference of proportions, Wald|29.51||||0.003|TWO_SIDED|95.0|10.76|48.26|||2-sample Z test for proportions|||CUSA-081 vs Placebo Dwell Time Up To 90 Min -- FAS||48.26|10.76|0.003
72538806|NCT03594175|144606950|NON_INFERIORITY|Non-inferiority was assessed based on the constructed 95% confidence interval (CI) for the difference in the rate of treatment success between CUSA-081 vs alteplase, with non-inferiority considered as demonstrated if the lower limit of the 95% CI for the difference in rate of success is greater than -10%.|Mean difference of proportions, Wald|-10.31||||0.03|TWO_SIDED|95.0|-19.38|-1.24|||2-sample Z test for proportions|||||-1.24|-19.38|0.030
72538807|NCT03594175|144606951|SUPERIORITY||Mean difference of proportions, Wald|24.13||||0.017|TWO_SIDED|95.0|5.84|42.41|||2-sample Z test for proportions|||||42.41|5.84|0.017
72538808|NCT03594175|144606952|SUPERIORITY||Mean difference of proportions, Wald|41.08|||<|0.001|TWO_SIDED|95.0|21.94|60.21|||2-sample Z test for proportions|||||60.21|21.94|<0.001
72538809|NCT03594175|144606953|SUPERIORITY||Mean difference of proportions, Wald|-10.96||||0.019|TWO_SIDED|95.0|-19.89|-2.04|||2-sample Z test for proportions|||||-2.04|-19.89|0.019
72538810|NCT03594175|144606954|SUPERIORITY||Probability Re-Occlusion Free at Day 30|0.948|||||TWO_SIDED|95.0|0.126|7.121||||||Time to first re-occlusion.||7.121|0.126|
72575219|NCT02792699|144676505|OTHER||Risk Ratio (RR)|0.9256|||||TWO_SIDED|90.0|0.64|1.3388||||||Risk ratio (ABP 798/ABP 798 versus Rituximab \[EU\]/Rituximab \[EU\]) at week 8, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||1.3388|0.6400|
72538811|NCT03594175|144606954|OTHER||Cox Proportional Hazard|0.654|||||TWO_SIDED|95.0|0.337|1.27||||||Time to first re-occlusion.||1.270|0.337|
72538812|NCT03594175|144606954|OTHER||Cox Proportional Hazard|1.448|||||TWO_SIDED|95.0|0.193|10.848||||||Time to first re-occlusion.||10.848|0.193|
72538813|NCT00633217|144607077|NON_INFERIORITY_OR_EQUIVALENCE|If the lower bound of the 95% confidence interval for the mean difference in 2-hour post-dose FEV1 change from baseline fell above -75 mL, then HFA MDI could be deemed non-inferior to DISKUS treatment response.||||||0.021||95.0|||||ANCOVA|||||||0.021
72538814|NCT02395536|144607119|NON_INFERIORITY|A non-inferiority margin of 5% was chosen since the inability to rule out a 5% increase in untoward event rate associated with moving the Reveal LINQ procedure in-office may suggest that in-office procedures would too high of a complication rate compared procedures performed in the traditional office setting.|Risk Difference (RD)|-0.001|||<|0.001|TWO_SIDED|95.0|-0.03|0.029||P-value for non-inferiority versus a 5% non-inferiority margin.|Farrington-Manning test||The estimated value and its associated confidence interval are for the in-office minus traditional hospital setting difference in the untoward event rates. The point estimate is negative since the in-office rate was lower than the hospital rate.|The null hypothesis was that Reveal LINQ insertions performed in-office would have a higher untoward event rate than insertions performed in the traditional hospital setting. A sample size of 476 subjects was estimated to provide at least 90% power at a 1-sided alpha level of 2.5% and 5% non-inferiority margin. For the sample size calculation, an event rate of 2.0% was assumed in both arms. The Farrington-Manning test of two indepent proportions was used to compare study arms.||0.029|-0.030|<0.001
72538815|NCT01788163|144607139|SUPERIORITY_OR_OTHER||Wald Chi Square Statistic|81.1237||||0.0001||||||Histology: Adenocarcinoma vs Non-adenocarcinoma|Regression stepwise|10% significance level for entry criteria||||||0.0001
72538816|NCT01788163|144607139|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.973||||0.0001||||||Histology: Adenocarcinoma vs Non-adenocarcinoma|Regression stepwise|10% significance level for model entry||||||0.0001
72538817|NCT01788163|144607139|SUPERIORITY_OR_OTHER||Wald Chi Square Statistic|7.1526||||0.0075||||||Gender: Male vs. Female|Regression Stepwise|10% significance level for entry criteria||||||0.0075
72538818|NCT01788163|144607139|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.409||||0.0075||||||Gender: Male vs. Female|Regression Stepwise|10% Significance Level for model entry||||||0.0075
72538819|NCT01788163|144607139|SUPERIORITY_OR_OTHER||Wald Chi Square Statistic|51.8456||||0.0001||||||Smoking Status: Never-smoker vs. Ever-smoker|Regression Stepwise|10% significance level for entry criteria||||||0.0001
72538820|NCT01788163|144607139|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.515||||0.0001||||||Smoking Status: Never-smoker vs. Ever-smoker|Regression Stepwise|10% Significance Level for model entry||||||0.0001
72538821|NCT01788163|144607139|SUPERIORITY_OR_OTHER||Wald Chi Square Statistic|98.1065||||0.0001||||||Region: Asia Pacific vs. Russia|Regression Stepwise|10% Significance Level for entry criteria||||||0.0001
72538822|NCT01788163|144607139|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.929||||0.0001||||||Region: Asia Pacific vs. Russia|Regression Stepwise|10% Significance Level for model entry||||||0.0001
72538823|NCT01788163|144607139|SUPERIORITY_OR_OTHER||Wald Chi Square Statistic|2.8589||||0.0909||||||Number of organs with metastasis|Regression Stepwise|10% significance level for entry criteria||||||0.0909
72538824|NCT01788163|144607139|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.086||||0.0909||||||Number of organs with metastasis|Regression Stepwise|10% significance level for model entry||||||0.0909
72538825|NCT01788163|144607142|SUPERIORITY_OR_OTHER||Wald Chi Square Statistic|11.106||||0.0009||||||Age: \<=65 vs. \>65|Regression Stepwise|10% Significance Level for entry criteria||||||0.0009
72538826|NCT01788163|144607142|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.561||||0.0009||||||Age: \<=65 vs. \>65|Regression Stepwise|10% Significance Level for model entry||||||0.0009
72538827|NCT01788163|144607142|SUPERIORITY_OR_OTHER||Wald Chi Square Statistic|34.1075||||0.0001||||||Number of Organs with Metastisis|Regression Stepwise|10% Significance Level for entry criteria||||||0.0001
72538828|NCT01788163|144607142|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.386||||0.0001||||||Number of Organs with Metastisis|Regression Stepwise|10% significance level for model entry||||||0.0001
72538829|NCT01788163|144607142|SUPERIORITY_OR_OTHER||Wald Chi Square Statistic|14.0806||||0.0002||||||Histology: Adenocarcinoma vs. Non-adenocarcinoma|Regression Stepwise|10% Significance Level for entry criteria||||||0.0002
72538830|NCT01788163|144607142|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.955||||0.0002||||||Histology: Adenocarcinoma vs. Non-adenocarcinoma|Regression Stepwise|10% Significance Level for model entry||||||0.0002
72538831|NCT01788163|144607142|SUPERIORITY_OR_OTHER||Wald Chi Square Statistic|33.8574||||0.0001||||||Smoking Status: Never-smoker vs. Ever-smoker|Regression Stepwise|10% Significance Level for entry criteria||||||0.0001
72538832|NCT01788163|144607142|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.077||||0.0001||||||Smoking Status: Never-smoker vs. Ever-smoker|Regression Stepwise|10% Significance Level for model entry||||||0.0001
72538833|NCT01788163|144607142|SUPERIORITY_OR_OTHER||Wald Chi Square Statistic|21.2537||||0.0001||||||Region: Asia Pacific vs. Russia|Regression Stepwise|10% Significance Level for entry criteria||||||0.0001
72538834|NCT01788163|144607142|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.084||||0.0001||||||Region: Asia Pacific vs. Russia|Regression Stepwise|10% Significance Level for model entry||||||0.0001
72538835|NCT00545441|144607147|NON_INFERIORITY_OR_EQUIVALENCE|Alpha = 0.05 and power = 0.8, a non-inferiority margin of 10%.||||||0.59|TWO_SIDED||||||Fisher Exact|||||||0.59
72538836|NCT03610646|144607152|EQUIVALENCE|An equivalence margin of \[-3, 3\] letters was used to demonstrate equivalence for the difference of mean change in BCVA, from baseline to Week 8.|Mean Difference (Final Values)|0.04|STANDARD_ERROR_OF_MEAN|0.73|||TWO_SIDED|90.0|-1.16|1.24||||||||1.24|-1.16|
72538837|NCT00467038|144607160|SUPERIORITY_OR_OTHER||||||<|0.004|TWO_SIDED||||||t-test, 1 sided|\<0.004 p value was common for all time points.||||||<0.004
72538838|NCT00467038|144607161|SUPERIORITY_OR_OTHER|||||||0.08|TWO_SIDED||||||Fisher's LSD post-hoc, trend level|||||||0.08
72538839|NCT04071366|144607171|SUPERIORITY||Difference in CRS rate|-0.39||||0.003|TWO_SIDED|95.0|-0.6463|-0.1363|||One-sided Z-test|||||-0.1363|-0.6463|0.0030
72538840|NCT04071366|144607171|OTHER||Difference in CRS rate|-0.37|||||TWO_SIDED|95.0|-0.6073|-0.1231||||||||-0.1231|-0.6073|
72538841|NCT04071366|144607171|OTHER||Difference in CRS rate|0.03|||||TWO_SIDED|95.0|-0.1778|0.2299||||||||0.2299|-0.1778|
72575220|NCT02792699|144676505|OTHER||Risk Difference (RD)|-0.0181|||||TWO_SIDED|90.0|-0.1209|0.0847||||||Risk difference (ABP 798/ABP 798 - Rituximab \[EU\]/Rituximab \[EU\]) at week 8, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||0.0847|-0.1209|
72575221|NCT02792699|144676505|OTHER||Risk Ratio (RR)|1.0868|||||TWO_SIDED|90.0|0.7328|1.6119||||||Risk ratio (ABP 798/ABP 798 versus Rituximab \[US\]/ABP 798\]) at week 8, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||1.6119|0.7328|
72575222|NCT02792699|144676505|OTHER||Risk Difference (RD)|0.0201|||||TWO_SIDED|90.0|-0.0803|0.1205||||||Risk difference (ABP 798/ABP 798 - Rituximab \[US\]/ABP 798) at week 8, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||0.1205|-0.0803|
72575223|NCT02792699|144676505|OTHER||Risk Ratio (RR)|0.7095|||||TWO_SIDED|90.0|0.5387|0.9346||||||Risk ratio (ABP 798/ABP 798 versus Rituximab \[EU\]/Rituximab \[EU\]) at week 12, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||0.9346|0.5387|
72575224|NCT02792699|144676505|OTHER||Risk Difference (RD)|-0.1109|||||TWO_SIDED|90.0|-0.2231|0.0013||||||Risk difference (ABP 798/ABP 798 - Rituximab \[EU\]/Rituximab \[EU\]) at week 12, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||0.0013|-0.2231|
72538842|NCT02216214|144607266|SUPERIORITY||Least Squares Mean (LSM) Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|-1.05|-0.33||P-value compares the Mirabegron group to the placebo group.|ANCOVA|||Difference vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, sex, age group (\<75, \>=75 years) and country as fixed factors and baseline value as a covariate.||-0.33|-1.05|<0.001
72538843|NCT02216214|144607267|SUPERIORITY||LSM Difference|-0.55|STANDARD_ERROR_OF_MEAN|0.14|<|0.001|TWO_SIDED|95.0|-0.82|-0.27||P-value compares the Mirabegron group to the placebo group.|ANCOVA|||Difference vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, sex, age group (\<75, \>=75 years) and country as fixed factors and baseline value as a covariate.||-0.27|-0.82|<0.001
72538844|NCT02216214|144607268|SUPERIORITY||LSM Difference|13.68|STANDARD_ERROR_OF_MEAN|4.45||0.002|TWO_SIDED|95.0|4.95|22.42||P-value compares the Mirabegron group to the placebo group.|stratified rank ANCOVA|||Difference vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the stratified rank ANCOVA model with treatment group, sex, age group (\<75, \>=75 years) and country as fixed factors and baseline value as a covariate.||22.42|4.95|0.002
72538845|NCT02216214|144607269|SUPERIORITY||LSM Difference|-5.15|STANDARD_ERROR_OF_MEAN|1.37|<|0.001|TWO_SIDED|95.0|-7.84|-2.46||P-value compares the Mirabegron group to the placebo group.|ANCOVA|||Difference vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, sex, age group (\<75, \>=75 years) and country as fixed factors and baseline value as a covariate.||-2.46|-7.84|<0.001
72538846|NCT02216214|144607270|SUPERIORITY||LSM Difference|2.72|STANDARD_ERROR_OF_MEAN|1.07||0.011|TWO_SIDED|95.0|0.62|4.83||P-value compares the Mirabegron group to the placebo group.|ANCOVA|||Difference vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, sex, age group (\<75, \>=75 years) and country as fixed factors and baseline value as a covariate.||4.83|0.62|0.011
72538847|NCT02216214|144607271|SUPERIORITY||LSM Difference|-0.31|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-0.46|-0.16||P-value compares the Mirabegron group to the placebo group.|ANCOVA|||Difference vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, sex, age group (\<75, \>=75 years) and country as fixed factors and baseline value as a covariate.||-0.16|-0.46|<0.001
72538848|NCT02216214|144607272|SUPERIORITY||||||<|0.001||||||P-value compares the Mirabegron group to the placebo group.|ANCOVA|||||||<0.001
72538849|NCT02216214|144607273|SUPERIORITY||Rate Ratio|0.68|||<|0.001||||||P-value compares the Mirabegron group to the placebo group.|Negative Binomial Regression Model|||The rate ratio for the number of urgency incontinence episodes reported during 3-day diary prior to each visit between mirabegron total group vs placebo group was calculated from a negative binomial regression model including treatment group, sex, age group (\<75, \>=75 years) and country as fixed factors and number of valid diary days as the offset variable.||||<0.001
72538850|NCT02216214|144607274|SUPERIORITY||Rate Ratio|0.84||||0.432||||||P-value compares the Mirabegron group to the placebo group.|Negative Binomial Regression Model|||The rate ratio for the number of nocturia episodes reported during 3-day diary prior to each visit between mirabegron total group vs placebo group is calculated from a negative binomial regression model including treatment group, sex, age group (\<75, \>=75 years) and country as fixed factors and number of valid diary days as the offset variable.||||0.432
72538851|NCT02216214|144607275|SUPERIORITY|||||||0.317||||||P-value compares the Mirabegron group to the placebo group.|ANCOVA|||||||0.317
72538852|NCT02216214|144607276|SUPERIORITY|||||||0.165||||||P-value compares the Mirabegron group to the placebo group.|ANCOVA|||||||0.165
72538853|NCT02216214|144607277|SUPERIORITY||||||<|0.001||||||P-value compares the Mirabegron group to the placebo group.|ANCOVA|||||||<0.001
72538854|NCT02216214|144607278|SUPERIORITY|||||||0.019||||||P-value compares the Mirabegron group to the placebo group.|ANCOVA|||Coping Subscale Score||||0.019
72538855|NCT02216214|144607278|SUPERIORITY|||||||0.01||||||P-value compares the Mirabegron group to the placebo group.|ANCOVA|||Concern Subscale Score||||0.010
72538856|NCT02216214|144607278|SUPERIORITY|||||||0.006||||||P-value compares the Mirabegron group to the placebo group.|ANCOVA|||Sleep Subscale Score||||0.006
72538857|NCT02216214|144607278|SUPERIORITY|||||||0.614||||||P-value compares the Mirabegron group to the placebo group.|ANCOVA|||Social Subscale Score||||0.614
72538858|NCT02216214|144607279|SUPERIORITY|||||||0.002||||||P-value compares the Mirabegron group to the placebo group.|ANCOVA|||||||0.002
72538859|NCT02216214|144607280|SUPERIORITY|||||||0.755||||||P-value compares the Mirabegron group to the placebo group.|ANCOVA|||||||0.755
72409663|NCT00807092|144327722|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.495|STANDARD_ERROR_OF_MEAN|0.247||0.0472||95.0|0.006|0.984||A statistical significant threshold p\<0.05|ANCOVA|Treatment and strata as factors; baseline (week 0) value of mean FBG as covariate||"The null hypothesis (H0) was:~H0: Change in FPG of BIAsp 30 after 6 weeks of treatment-Change in FPG of BHI 30 after 6 weeks of treatment =0 mmol/L against the alternative hypothesis(H1): H1: Change in FPG of BIAsp 30 after 6 weeks of treatment-Change in FPG of BHI 30 after 6 weeks of treatment≠0 mmol/L"||0.984|0.0060|0.0472
72409664|NCT00807092|144327723|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.11||||0.676||95.0|-0.41|0.63||A statistical significant threshold p\<0.05|ANCOVA|Treatment and strata as factors; baseline (week 2) value of BG as covariate|Before breakfast|"For each endpoint of SMBG :The null hypothesis (H0) was:~H0: Change in BG of BIAsp 30 after 6 weeks of treatment-Change in BG of BHI 30 after 6 weeks of treatment =0 mmol/L against the alternative hypothesis(H1): H1: Change in BG of BIAsp 30 after 6 weeks of treatment-Change in BG of BHI 30 after 6 weeks of treatment≠0 mmol/L"||0.63|-0.41|0.676
72409665|NCT00807092|144327723|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.23||||0.026||95.0|0.15|2.31||A statistical significant threshold p\<0.05|ANCOVA|Treatment and strata as factors; baseline (week 0) value of BG as covariate|2 hours after breakfast|"For each endpoint of SMBG :The null hypothesis (H0) was:~H0: Change in BG of BIAsp 30 after 6 weeks of treatment-Change in BG of BHI 30 after 6 weeks of treatment =0 mmol/L against the alternative hypothesis(H1): H1: Change in BG of BIAsp 30 after 6 weeks of treatment-Change in BG of BHI 30 after 6 weeks of treatment≠0 mmol/L"||2.31|0.15|0.026
72409666|NCT00807092|144327723|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.27||||0.5||95.0|-0.53|1.08||A statistical significant threshold p\<0.05|ANCOVA|Treatment and strata as factors; baseline (week 0) value of BG as covariate|Before lunch|"For each endpoint of SMBG :The null hypothesis (H0) was:~H0: Change in BG of BIAsp 30 after 6 weeks of treatment-Change in BG of BHI 30 after 6 weeks of treatment =0 mmol/L against the alternative hypothesis(H1): H1: Change in BG of BIAsp 30 after 6 weeks of treatment-Change in BG of BHI 30 after 6 weeks of treatment≠0 mmol/L"||1.08|-0.53|0.5
72409667|NCT00807092|144327723|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.17||||0.747||95.0|-0.86|1.19||A statistical significant threshold p\<0.05|ANCOVA|Treatment and strata as factors; baseline (week 0) value of BG as covariate|2 hours after lunch|"For each endpoint of SMBG :The null hypothesis (H0) was:~H0: Change in BG of BIAsp 30 after 6 weeks of treatment-Change in BG of BHI 30 after 6 weeks of treatment =0 mmol/L against the alternative hypothesis(H1): H1: Change in BG of BIAsp 30 after 6 weeks of treatment-Change in BG of BHI 30 after 6 weeks of treatment≠0 mmol/L"||1.19|-0.86|0.747
72409668|NCT00807092|144327723|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.27||||0.581||95.0|-1.23|0.69||A statistical significant threshold p\<0.05|ANCOVA|Treatment and strata as factors; baseline (week 0) value of BG as covariate|Before dinner|"For each endpoint of SMBG :The null hypothesis (H0) was:~H0: Change in BG of BIAsp 30 after 6 weeks of treatment-Change in BG of BHI 30 after 6 weeks of treatment =0 mmol/L against the alternative hypothesis(H1): H1: Change in BG of BIAsp 30 after 6 weeks of treatment-Change in BG of BHI 30 after 6 weeks of treatment≠0 mmol/L"||0.69|-1.23|0.581
72409669|NCT00807092|144327723|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.47||||0.326||95.0|-1.42|0.48||A statistical significant threshold p\<0.05|ANCOVA|Treatment and strata as factors; baseline (week 0) value of BG as covariate|2 hours after dinner|"For each endpoint of SMBG :The null hypothesis (H0) was:~H0: Change in BG of BIAsp 30 after 6 weeks of treatment-Change in BG of BHI 30 after 6 weeks of treatment =0 mmol/L against the alternative hypothesis(H1): H1: Change in BG of BIAsp 30 after 6 weeks of treatment-Change in BG of BHI 30 after 6 weeks of treatment≠0 mmol/L"||0.48|-1.42|0.326
72538860|NCT02216214|144607281|SUPERIORITY||Rate Ratio|0.8||||0.014|TWO_SIDED|95.0|0.67|0.96||P-value compares the Mirabegron group to the placebo group.|Negative Binomial Regression Model|||Week 4: Rate ratio for the number of incontinence episodes reported during 3-day diary prior to each visit between mirabegron group vs placebo group is calculated from a negative binomial regression model including treatment group, sex, age group (\<75, \>=75 years) and country as factors and number of valid diary days as the offset variable.||0.96|0.67|0.014
72538861|NCT02216214|144607281|SUPERIORITY||Rate Ratio|0.81||||0.043|TWO_SIDED|95.0|0.66|0.99||P-value compares the Mirabegron group to the placebo group.|Negative Binomial Regression Model|||Week 8: Rate ratio for the number of incontinence episodes reported during 3-day diary prior to each visit between mirabegron group vs placebo group is calculated from a negative binomial regression model including treatment group, sex, age group (\<75, \>=75 years) and country as factors and number of valid diary days as the offset variable.||0.99|0.66|0.043
72538862|NCT02216214|144607281|SUPERIORITY||Rate Ratio|0.69||||0.002|TWO_SIDED|95.0|0.54|0.87||P-value compares the Mirabegron group to the placebo group.|Negative Binomial Regression Model|||EOT: Rate ratio for the number of incontinence episodes reported during 3-day diary prior to each visit between mirabegron group vs placebo group is calculated from a negative binomial regression model including treatment group, sex, age group (\<75, \>=75 years) and country as factors and number of valid diary days as the offset variable.||0.87|0.54|0.002
72538863|NCT02216214|144607283|SUPERIORITY||Odds Ratio (OR)|1.5||||0.005||||||P-value compares the Mirabegron group to the placebo group.|Regression, Logistic|||Odds Ratio: Logistic regression was performed with treatment group, sex, age group (\<75, \>=75 years), and country as fixed factors and baseline value as a covariate.||||0.005
72409670|NCT00807092|144327723|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.19||||0.643||95.0|-0.61|0.99||A statistical significant threshold p\<0.05|ANCOVA|Treatment and strata as factors; baseline (week 0) value of BG as covariate|Bedtime|"For each endpoint of SMBG :The null hypothesis (H0) was:~H0: Change in BG of BIAsp 30 after 6 weeks of treatment-Change in BG of BHI 30 after 6 weeks of treatment =0 mmol/L against the alternative hypothesis(H1): H1: Change in BG of BIAsp 30 after 6 weeks of treatment-Change in BG of BHI 30 after 6 weeks of treatment≠0 mmol/L"||0.99|-0.61|0.643
72538864|NCT02216214|144607284|SUPERIORITY||Odds Ratio (OR)|1.775|||<|0.001||||||P-value compares the Mirabegron group to the placebo group.|Regression, Logistic|||Odds Ratio: Logistic regression was performed with treatment group, sex, age group (\<75, \>=75 years), and country as fixed factors and baseline value as a covariate.||||<0.001
72538865|NCT02216214|144607285|SUPERIORITY||Odds Ratio (OR)|1.501||||0.012||||||P-value compares the Mirabegron group to the placebo group.|Regression, Logistic|||Odds Ratio: Logistic regression was performed with treatment group, sex, age group (\<75, \>=75 years), and country as fixed factors and baseline value as a covariate.||||0.012
72409671|NCT00807092|144327723|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.77||||0.008||95.0|0.21|1.33||A statistical significant threshold p\<0.05|ANCOVA|Treatment and strata as factors; baseline (week 0) value of BG as covariate|3 AM|"For each endpoint of SMBG :The null hypothesis (H0) was:~H0: Change in BG of BIAsp 30 after 6 weeks of treatment-Change in BG of BHI 30 after 6 weeks of treatment =0 mmol/L against the alternative hypothesis(H1): H1: Change in BG of BIAsp 30 after 6 weeks of treatment-Change in BG of BHI 30 after 6 weeks of treatment≠0 mmol/L"||1.33|0.21|0.0080
72409672|NCT00807092|144327723|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.27||||0.274||95.0|-0.22|0.75||A statistical significant threshold p\<0.05|ANCOVA|Treatment and strata as factors; baseline (week 0) value of BG as covariate|Average|"For each endpoint of SMBG :The null hypothesis (H0) was:~H0: Change in BG of BIAsp 30 after 6 weeks of treatment-Change in BG of BHI 30 after 6 weeks of treatment =0 mmol/L against the alternative hypothesis(H1): H1: Change in BG of BIAsp 30 after 6 weeks of treatment-Change in BG of BHI 30 after 6 weeks of treatment≠0 mmol/L"||0.75|-0.22|0.274
72409673|NCT00807092|144327724|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.99||||0.062||95.0|-0.05|2.04||A statistical significant threshold p\<0.05|ANCOVA|Treatment and strata as factors; baseline (week 0) value of prandial BG increment as covariate|Breakfast|"For each endpoint of Prandial Blood Glucose Increment :The null hypothesis (H0) was:~H0: Change in prandial BG increment of BIAsp 30 after 6 weeks of treatment-Change in prandial BG increment of BHI 30 after 6 weeks of treatment =0 mmol/L against the alternative hypothesis(H1): H1: Change in prandial BG increment of BIAsp 30 after 6 weeks of treatment-Change in prandial BG increment of BHI 30 after 6 weeks of treatment≠0 mmol/L"||2.04|-0.05|0.062
72409674|NCT00807092|144327724|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.05||||0.933||95.0|-1.12|1.22||A statistical significant threshold p\<0.05|ANCOVA|Treatment and strata as factors; baseline (week 0) value of prandial BG increment as covariate|Lunch|"For each endpoint of Prandial Blood Glucose Increment :The null hypothesis (H0) was:~H0: Change in prandial BG increment of BIAsp 30 after 6 weeks of treatment-Change in prandial BG increment of BHI 30 after 6 weeks of treatment =0 mmol/L against the alternative hypothesis(H1): H1: Change in prandial BG increment of BIAsp 30 after 6 weeks of treatment-Change in prandial BG increment of BHI 30 after 6 weeks of treatment≠0 mmol/L"||1.22|-1.12|0.933
72409675|NCT00807092|144327724|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.05||||0.922||95.0|-1.16|1.05||A statistical significant threshold p\<0.05|ANCOVA|Treatment and strata as factors; baseline (week 0) value of prandial BG increment as covariate|Dinner|"For each endpoint of Prandial Blood Glucose Increment :The null hypothesis (H0) was:~H0: Change in prandial BG increment of BIAsp 30 after 6 weeks of treatment-Change in prandial BG increment of BHI 30 after 6 weeks of treatment =0 mmol/L against the alternative hypothesis(H1): H1: Change in prandial BG increment of BIAsp 30 after 6 weeks of treatment-Change in prandial BG increment of BHI 30 after 6 weeks of treatment≠0 mmol/L"||1.05|-1.16|0.922
72409676|NCT00807092|144327724|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.29||||0.313||95.0|-0.28|0.85||A statistical significant threshold p\<0.05|ANCOVA|Treatment and strata as factors; baseline (week 0) value of prandial BG increment as covariate|Average|"For each endpoint of Prandial Blood Glucose Increment :The null hypothesis (H0) was:~H0: Change in prandial BG increment of BIAsp 30 after 6 weeks of treatment-Change in prandial BG increment of BHI 30 after 6 weeks of treatment =0 mmol/L against the alternative hypothesis(H1): H1: Change in prandial BG increment of BIAsp 30 after 6 weeks of treatment-Change in prandial BG increment of BHI 30 after 6 weeks of treatment≠0 mmol/L"||0.85|-0.28|0.313
72538866|NCT02216214|144607286|SUPERIORITY||Odds Ratio (OR)|1.39||||0.034||||||P-value compares the Mirabegron group to the placebo group.|Regression, Logistic|||HRQL Subscale - Coping. Odds Ratio: Logistic regression was performed with treatment group, sex, age group (\<75, \>=75 years), and country as fixed factors and baseline value as a covariate.||||0.034
72538867|NCT02216214|144607286|SUPERIORITY||Odds Ratio (OR)|1.327||||0.07||||||P-value compares the Mirabegron group to the placebo group.|Regression, Logistic|||HRQL Subscale - Concern. Odds Ratio: Logistic regression was performed with treatment group, sex, age group (\<75, \>=75 years), and country as fixed factors and baseline value as a covariate.||||0.070
72538868|NCT02216214|144607286|SUPERIORITY||Odds Ratio (OR)|1.452||||0.012||||||P-value compares the Mirabegron group to the placebo group.|Regression, Logistic|||HRQL Subscale - Sleep. Odds Ratio: Logistic regression was performed with treatment group, sex, age group (\<75, \>=75 years), and country as fixed factors and baseline value as a covariate.||||0.012
72538869|NCT02216214|144607286|SUPERIORITY||Odds Ratio (OR)|1.116||||0.602||||||P-value compares the Mirabegron group to the placebo group.|Regression, Logistic|||HRQL Subscale - Social. Odds Ratio: Logistic regression was performed with treatment group, sex, age group (\<75, \>=75 years), and country as fixed factors and baseline value as a covariate.||||0.602
72538870|NCT02216214|144607287|SUPERIORITY||Odds Ratio (OR)|1.634||||0.001||||||P-value compares the Mirabegron group to the placebo group.|Regression, Logistic|||Odds Ratio: Logistic regression was performed with treatment group, sex, age group (\<75, \>=75 years), and country as fixed factors and baseline value as a covariate.||||0.001
72538871|NCT02216214|144607288|SUPERIORITY||Odds Ratio (OR)|1.597||||0.003||||||P-value compares the Mirabegron group to the placebo group.|Regression, Logistic|||Odds Ratio: Logistic regression was performed with treatment group, sex, age group (\<75, \>=75 years), and country as fixed factors and baseline value as a covariate.||||0.003
72538872|NCT02216214|144607290|SUPERIORITY|||||||0.471||||||P-value compares the Mirabegron group to the placebo group.|ANCOVA|||||||0.471
72538873|NCT00713830|144607292|SUPERIORITY_OR_OTHER||Least squares (LS) mean difference|-0.74|STANDARD_ERROR_OF_MEAN|0.063|<|0.0001|TWO_SIDED|95.0|-0.867|-0.621||Statistical testing: 2-sided at significance level=0.05. Analysis of co-variance (ANCOVA) included treatment arms, randomization strata of screening HbA1c (\<8.0, \>=8.0%), metformin use (yes, no), country as fixed effects, baseline HbA1c as covariate.|ANCOVA|||To detect a difference of 0.5% (or 0.4%) in change from baseline to Week 24 in HbA1c between lixisenatide and placebo, 570 patients in lixisenatide arm and 285 in placebo arm would provide a power of 99% (or 98%) assuming common standard deviation of 1.3% with a 2-sided test at 5% significance level.||-0.621|-0.867|<0.0001
72538874|NCT00703261|144607392|SUPERIORITY_OR_OTHER|||||||0.006||95.0|||||cLDA|||Constrained longitudinal data analysis (cLDA)||||0.006
72538875|NCT00703261|144607392|SUPERIORITY_OR_OTHER|||||||0.277||95.0|||||cLDA|||||||0.277
72538876|NCT00703261|144607392|SUPERIORITY_OR_OTHER||Percent Reduction|4.5||||0.088|TWO_SIDED|90.0|-1.0|9.6|||cLDA|||||9.6|-1.0|0.088
72538877|NCT00703261|144607393|SUPERIORITY_OR_OTHER|||||||0.195||95.0|||||cLDA|||||||0.195
72538878|NCT02115373|144607403|OTHER||Median|2.07|||||TWO_SIDED|90.0|1.446|7.195|||||TTP in months was calculated for Phase 1b: Tepotinib 300 mg and Phase 1b: Tepotinib 500 mg combined.|||7.195|1.446|
72538879|NCT02115373|144607403|OTHER||Median|3.98|||||TWO_SIDED|90.0|2.858|4.238|||||TTP in months was calculated for Phase 2: Tepotinib 500 mg.|||4.238|2.858|
72538880|NCT02115373|144607404|OTHER||Median|1.51|||||TWO_SIDED|90.0|1.413|3.68|||||PFS time in months was calculated for Phase 1b: Tepotinib 300 mg and Phase 1b: Tepotinib 500 mg combined.|||3.680|1.413|
72538881|NCT02115373|144607404|OTHER||Median|3.22|||||TWO_SIDED|90.0|0.03|16.53|||||PFS time in months was calculated for Phase 2: Tepotinib 500 mg.|||16.53|0.03|
72538882|NCT02115373|144607405|OTHER||Median|1.48|||||TWO_SIDED|90.0|1.413|3.844|||||PFS time in months was calculated for Phase 1b: Tepotinib 300 mg and Phase 1b: Tepotinib 500 mg combined.|||3.844|1.413|
72538883|NCT02115373|144607405|OTHER||Median|3.35|||||TWO_SIDED|90.0|2.76|4.172|||||PFS time in months was was calculated for Phase 2: Tepotinib 500 mg.|||4.172|2.760|
72538884|NCT02115373|144607407|OTHER||Median|7.2|||||TWO_SIDED|90.0|3.68|10.119|||||Overall Survival time in months was calculated for Phase 1b: Tepotinib 300 mg and Phase 1b: Tepotinib 500 mg combined.|||10.119|3.680|
72538885|NCT02115373|144607407|OTHER||Median|5.55|||||TWO_SIDED|90.0|5.092|8.181|||||Overall Survival time in months was calculated for Phase 2: Tepotinib 500 mg.|||8.181|5.092|
72538886|NCT01215955|144607437|SUPERIORITY_OR_OTHER||LS Mean Difference|0.04|||||TWO_SIDED|95.0|-0.15|0.22|||||No imputation was performed. Participants without a 24-week value were handled by the statistical model.|||0.22|-0.15|
72575225|NCT02792699|144676505|OTHER||Risk Ratio (RR)|1.0882|||||TWO_SIDED|90.0|0.7829|1.5127||||||Risk ratio (ABP 798/ABP 798 versus Rituximab \[US\]/ABP 798\]) at week 12, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||1.5127|0.7829|
72575226|NCT02792699|144676505|OTHER||Risk Difference (RD)|0.0441|||||TWO_SIDED|90.0|-0.0626|0.1508||||||Risk difference (ABP 798/ABP 798 - Rituximab \[US\]/ABP 798) at week 12, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||0.1508|-0.0626|
72627368|NCT05136170|144783688|SUPERIORITY|||||||0.914||||||p-value corresponds to a non-parametric Mann-Whitney-Wilcoxon (Wilcoxon rank sum) test of the comparisons between Cenegermin and Vehicle in all patients.|Wilcoxon (Mann-Whitney)|||Herein analysis for Global score - Week 16 (Visit 6) was reported.||||0.914
72627369|NCT05136170|144783688|SUPERIORITY|||||||0.874||||||p-value corresponds to two sample (independent group) t-test of the comparisons between Cenegermin and Vehicle in all patients.|t-test, 2 sided|||Herein analysis for Severity - Week 8 (Visit 4) was reported.||||0.874
72538887|NCT01215955|144607437|SUPERIORITY_OR_OTHER||LS Mean Difference|0.06|||||TWO_SIDED|95.0|-0.12|0.24|||||No imputation was performed. Participants without a 24-week value were handled by the statistical model.|||0.24|-0.12|
72538888|NCT01215955|144607438|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.75||||0.128|TWO_SIDED|95.0|0.52|1.09||P-value is for HbA1c ≤7.0% at endpoint (LOCF). Logistic regression included treatment and effects for baseline stratification variables: baseline HbA1c (≤8% or \>8%), country and sulfonylurea/meglitinide use. Comparison calculated as Q3D versus Q1D.|Regression, Logistic|||||1.09|0.520|0.128
72538889|NCT01215955|144607438|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.9||||0.625|TWO_SIDED|95.0|0.58|1.39||P-value is for HbA1c ≤6.5% at endpoint (LOCF). Logistic regression included treatment and effects for baseline stratification variables: baseline HbA1c (≤8% or \>8%), country and sulfonylurea/meglitinide use. Comparison calculated as Q3D versus Q1D.|Regression, Logistic|||||1.39|0.580|0.625
72538890|NCT01215955|144607438|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.77||||0.162|TWO_SIDED|95.0|0.53|1.11||P-value is for HbA1c ≤7.0% at endpoint (LOCF). Logistic regression included treatment and effects for baseline stratification variables: baseline HbA1c (≤8% or \>8%), country and sulfonylurea/meglitinide use. Comparison calculated as Q3D versus Q1D.|Regression, Logistic|||||1.11|0.53|0.162
72538891|NCT01215955|144607438|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.93||||0.723|TWO_SIDED|95.0|0.61|1.4||P-value is for HbA1c ≤6.5% at endpoint (LOCF). Logistic regression included treatment and effects for baseline stratification variables: baseline HbA1c (≤8% or \>8%), country and sulfonylurea/meglitinide use. Comparison calculated as Q3D versus Q1D.|Regression, Linear|||||1.40|0.61|0.723
72538892|NCT01215955|144607439|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.17||||0.701|TWO_SIDED|95.0|0.52|2.67||P-value is for HbA1c ≤7.0% at endpoint (LOCF). Logistic regression included treatment and effects for baseline stratification variables: baseline HbA1c (≤8% or \>8%), country and sulfonylurea/meglitinide use. Comparison calculated as Q3D versus Q1D.|Regression, Logistic|||||2.67|0.520|0.701
72538893|NCT01215955|144607439|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.62||||0.249|TWO_SIDED|95.0|0.71|3.7||P-value is for HbA1c ≤6.5% at endpoint (LOCF). Logistic regression included treatment and effects for baseline stratification variables: baseline HbA1c (≤8% or \>8%), country and sulfonylurea/meglitinide use. Comparison calculated as Q3D versus Q1D.|Regression, Logistic|||||3.70|0.710|0.249
72538894|NCT01215955|144607439|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.32||||0.015|TWO_SIDED|95.0|0.13|0.8||P-value is for HbA1c ≤7% at endpoint (LOCF). Logistic regression included treatment and effects for baseline stratification variables: baseline HbA1c (≤8% or \>8%), country and sulfonylurea/meglitinide use. Comparison calculated as Q3D versus Q1D.|Regression, Logistic|Included treatment and effects for baseline stratification variables: Baseline HbA1c (≤8% or \>8%), country and sulfonylurea/meglitinide use.||||0.80|0.13|0.015
72538895|NCT01215955|144607439|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.43||||0.078|TWO_SIDED|95.0|0.17|1.1||P-value is for HbA1c ≤6.5% at endpoint (LOCF). Logistic regression included treatment and effects for baseline stratification variables: baseline HbA1c (≤8% or \>8%), country and sulfonylurea/meglitinide use. Comparison calculated as Q3D versus Q1D.|Regression, Logistic|||||1.10|0.17|0.078
72575227|NCT02792699|144676505|OTHER||Risk Ratio (RR)|0.9612|||||TWO_SIDED|90.0|0.7273|1.2705||||||Risk ratio (ABP 798/ABP 798 versus Rituximab \[EU\]/Rituximab \[EU\]) at week 24, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||1.2705|0.7273|
72627370|NCT05136170|144783688|SUPERIORITY|||||||0.945||||||p-value corresponds to a non-parametric Mann-Whitney-Wilcoxon (Wilcoxon rank sum) test of the comparisons between Cenegermin and Vehicle in all patients.|Wilcoxon (Mann-Whitney)|||Herein analysis for Severity - Week 12 (Visit 5) was reported.||||0.945
72575228|NCT02792699|144676505|OTHER||Risk Difference (RD)|0.002|||||TWO_SIDED|90.0|-0.1081|0.1122||||||Risk difference (ABP 798/ABP 798 - Rituximab \[EU\]/Rituximab \[EU\]) at week 24, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||0.1122|-0.1081|
72575229|NCT02792699|144676505|OTHER||Risk Ratio (RR)|1.0029|||||TWO_SIDED|90.0|0.756|1.3305||||||Risk ratio (ABP 798/ABP 798 versus Rituximab \[US\]/ABP 798\]) at week 24, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||1.3305|0.7560|
72575230|NCT02792699|144676505|OTHER||Risk Difference (RD)|0.0039|||||TWO_SIDED|90.0|-0.1056|0.1135||||||Risk difference (ABP 798/ABP 798 - Rituximab \[US\]/ABP 798) at week 24, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||0.1135|-0.1056|
72575231|NCT02792699|144676505|OTHER||Risk Ratio (RR)|0.8373|||||TWO_SIDED|90.0|0.6797|1.0316||||||Risk ratio (ABP 798/ABP 798 versus Rituximab \[EU\]/Rituximab \[EU\]) at week 40, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||1.0316|0.6797|
72575232|NCT02792699|144676505|OTHER||Risk Difference (RD)|-0.0863|||||TWO_SIDED|90.0|-0.2029|0.0302||||||Risk difference (ABP 798/ABP 798 - Rituximab \[EU\]/Rituximab \[EU\]) at week 40, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||0.0302|-0.2029|
72575233|NCT02792699|144676505|OTHER||Risk Ratio (RR)|1.1191|||||TWO_SIDED|90.0|0.878|1.4264||||||Risk ratio (ABP 798/ABP 798 versus Rituximab \[US\]/ABP 798\]) at week 40, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||1.4264|0.8780|
72575234|NCT02792699|144676505|OTHER||Risk Difference (RD)|0.0288|||||TWO_SIDED|90.0|-0.0827|0.1402||||||Risk difference (ABP 798/ABP 798 - Rituximab \[US\]/ABP 798) at week 40, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||0.1402|-0.0827|
72575235|NCT02792699|144676505|OTHER||Risk Ratio (RR)|0.8376|||||TWO_SIDED|90.0|0.6807|1.0307||||||Risk ratio (ABP 798/ABP 798 versus Rituximab \[EU\]/Rituximab \[EU\]) at week 48, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||1.0307|0.6807|
72575236|NCT02792699|144676505|OTHER||Risk Difference (RD)|-0.0781|||||TWO_SIDED|90.0|-0.2014|0.0452||||||Risk difference (ABP 798/ABP 798 - Rituximab \[EU\]/Rituximab \[EU\]) at week 48, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||0.0452|-0.2014|
72575237|NCT02792699|144676505|OTHER||Risk Ratio (RR)|1.0548|||||TWO_SIDED|90.0|0.8351|1.3321||||||Risk ratio (ABP 798/ABP 798 versus Rituximab \[US\]/ABP 798\]) at week 48, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||1.3321|0.8351|
72575238|NCT02792699|144676505|OTHER||Risk Difference (RD)|0.0141|||||TWO_SIDED|90.0|-0.1021|0.1303||||||Risk difference (ABP 798/ABP 798 - Rituximab \[US\]/ABP 798) at week 48, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||0.1303|-0.1021|
72575239|NCT02792699|144676506|OTHER||Risk Ratio (RR)|0.5926|||||TWO_SIDED|90.0|0.2818|1.2462||||||Risk ratio (ABP 798/ABP 798 versus Rituximab \[EU\]/Rituximab \[EU\]) at week 8, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||1.2462|0.2818|
72575240|NCT02792699|144676506|OTHER||Risk Difference (RD)|-0.0574|||||TWO_SIDED|90.0|-0.1285|0.0136||||||Risk difference (ABP 798/ABP 798 - Rituximab \[EU\]/Rituximab \[EU\]) at week 8, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||0.0136|-0.1285|
72575241|NCT02792699|144676506|OTHER||Risk Ratio (RR)|0.7476|||||TWO_SIDED|90.0|0.3383|1.6519||||||Risk ratio (ABP 798/ABP 798 versus Rituximab \[US\]/ABP 798\]) at week 8, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||1.6519|0.3383|
72575242|NCT02792699|144676506|OTHER||Risk Difference (RD)|-0.0327|||||TWO_SIDED|90.0|-0.0962|0.0308||||||Risk difference (ABP 798/ABP 798 - Rituximab \[US\]/ABP 798) at week 8, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||0.0308|-0.0962|
72575243|NCT02792699|144676506|OTHER||Risk Ratio (RR)|0.6346|||||TWO_SIDED|90.0|0.3704|1.0872||||||Risk ratio (ABP 798/ABP 798 versus Rituximab \[EU\]/Rituximab \[EU\]) at week 12, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||1.0872|0.3704|
72575244|NCT02792699|144676506|OTHER||Risk Difference (RD)|-0.0569|||||TWO_SIDED|90.0|-0.1448|0.031||||||Risk difference (ABP 798/ABP 798 - Rituximab \[EU\]/Rituximab \[EU\]) at week 12, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||0.0310|-0.1448|
72575245|NCT02792699|144676506|OTHER||Risk Ratio (RR)|0.7857|||||TWO_SIDED|90.0|0.445|1.3874||||||Risk ratio (ABP 798/ABP 798 versus Rituximab \[US\]/ABP 798\]) at week 12, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||1.3874|0.4450|
72575246|NCT02792699|144676506|OTHER||Risk Difference (RD)|-0.0417|||||TWO_SIDED|90.0|-1237.0|0.0403||||||Risk difference (ABP 798/ABP 798 - Rituximab \[US\]/ABP 798) at week 12, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||0.0403|-1237|
72409677|NCT00807092|144327725|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.187|STANDARD_ERROR_OF_MEAN|0.371||0.6149||95.0|-0.547|0.921||A statistical significant threshold p\<0.05|ANCOVA|Treatment and strata as factors; baseline (visit 2) value of mean MAGE as covariate||The full analysis set using LOCF (Last Observation Carried Forward) consists of all randomised subjects who had been exposed to at least one dose of the trial products.||0.921|-0.547|0.6149
72538896|NCT01215955|144607440|SUPERIORITY_OR_OTHER||LS Mean Differences|0.81||||0.014|TWO_SIDED|95.0|0.17|1.46||No imputation was performed. Participants without a 24-week value were handled by the statistical model. Comparison is calculated as Q3D versus Q1D.|Mixed Models Analysis|||||1.46|0.17|0.014
72538897|NCT01215955|144607440|SUPERIORITY_OR_OTHER||LS Mean Differences|-0.5||||0.108|TWO_SIDED|95.0|-1.12|0.11||No imputation was performed. Participants without a 24-week value were handled by the statistical model. Comparison is calculated as Q3D versus Q1D.|Mixed Models Analysis|||||0.11|-1.12|0.108
72538898|NCT01215955|144607441|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.8||||0.182|TWO_SIDED|95.0|0.57|1.11||Comparison is calculated as Q3D versus Q1D.|Regression, Cox|Cox Regression model with effects for treatment and baseline stratification variables (HbA1c, country, sulfonylurea/meglitinide use) was used.||||1.11|0.57|0.182
72409678|NCT00807092|144327726|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.328|STANDARD_ERROR_OF_MEAN|0.577||0.5706||95.0|-0.813|1.468||A statistical significant threshold p\<0.05|ANCOVA|Treatment and strata as factors; baseline (week 0) value of GA as covariate||"The null hypothesis (H0) was:~H0: Change in GA of BIAsp 30 after 6 weeks of treatment-Change in GA of BHI 30 after 6 weeks of treatment =0 % against the alternative hypothesis(H1): H1: Change in GA of BIAsp 30 after 6 weeks of treatment-Change in GA of BHI 30 after 6 weeks of treatment≠0 %"||1.468|-0.813|0.5706
72538899|NCT01215955|144607441|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.89||||0.46|TWO_SIDED|95.0|0.65|1.22||Comparison is calculated as Q3D versus Q1D.|Regression, Cox|Cox Regression model with effects for treatment and baseline stratification variables (HbA1c, country, sulfonylurea/meglitinide use) was used.||||1.22|0.65|0.460
72538900|NCT01215955|144607442|SUPERIORITY_OR_OTHER||LS Mean Differences|0.29|||||TWO_SIDED|95.0|-0.19|0.77|||||No imputation was performed. Participants without a 24-week value were handled by the statistical model. Comparison is calculated as Q3D versus Q1D.|||0.77|-0.19|
72538901|NCT01215955|144607442|SUPERIORITY_OR_OTHER||LS Mean Differences|0.81|||||TWO_SIDED|95.0|0.3|1.31|||||No imputation was performed. Participants without a 24-week value were handled by the statistical model. Comparison is calculated as Q3D versus Q1D.|||1.31|0.30|
72538902|NCT01215955|144607443|SUPERIORITY_OR_OTHER||LS Mean Differences|0.59||||0.242|TWO_SIDED|95.0|-0.4|1.58||Comparison is calculated as Q3D versus Q1D.|Mixed Models Analysis||No imputation was performed. Participants without a 24-week value were handled by the statistical model.|||1.58|-0.40|0.242
72538903|NCT01215955|144607443|SUPERIORITY_OR_OTHER||LS Mean Differences|1.13||||0.082|TWO_SIDED|95.0|-0.15|2.41||Comparison is calculated as Q3D versus Q1D.|Mixed Models Analysis||No imputation was performed. Participants without 24-week values were handled by the statistical model.|||2.41|-0.15|0.082
72538904|NCT01215955|144607444|SUPERIORITY_OR_OTHER||LS Mean Differences|-0.15||||0.723|TWO_SIDED|95.0|-0.95|0.66||Comparison is calculated as Q3D versus Q1D.|Mixed Models Analysis||No imputation was performed. Participants without a 24-week value were handled by the statistical model|||0.66|-0.95|0.723
72575247|NCT02792699|144676506|OTHER||Risk Ratio (RR)|0.9254|||||TWO_SIDED|90.0|0.5772|1.4838||||||Risk ratio (ABP 798/ABP 798 versus Rituximab \[EU\]/Rituximab \[EU\]) at week 24, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||1.4838|0.5772|
72575248|NCT02792699|144676506|OTHER||Risk Difference (RD)|0.0156|||||TWO_SIDED|90.0|-0.078|0.1092||||||Risk difference (ABP 798/ABP 798 - Rituximab \[EU\]/Rituximab \[EU\]) at week 24, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||0.1092|-0.0780|
72538905|NCT01215955|144607444|SUPERIORITY_OR_OTHER||LS Mean Differences|-0.28||||0.495|TWO_SIDED|95.0|-1.08|0.52||Comparison is calculated as Q3D versus Q1D.|Mixed Models Analysis||No imputation was performed. Participants without a 24-week value were handled by the statistical model|||0.52|-1.08|0.495
72538906|NCT01215955|144607445|SUPERIORITY_OR_OTHER||LS Mean Difference|3.32||||0.245|TWO_SIDED|95.0|-2.28|8.93||P-value is for Morning Pre-meal. No imputation was performed. Participants without a 24-week value were handled by the statistical model. Comparison is calculated as Q3D versus Q1D.|Mixed Models Analysis|||||8.93|-2.28|0.245
72538907|NCT01215955|144607445|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.71||||0.842|TWO_SIDED|95.0|-7.71|6.29||P-value is for Morning 2-HR PP. No imputation was performed. Participants without a 24-week value were handled by the statistical model. Comparison is calculated as Q3D versus Q1D.|Mixed Models Analysis|||||6.29|-7.71|0.842
72538908|NCT01215955|144607445|SUPERIORITY_OR_OTHER||LS Mean Difference|1.42||||0.626||95.0|-4.32|7.16||P-value is for Midday Pre-Meal. No imputation was performed. Participants without a 24-week value were handled by the statistical model. Comparison is calculated as Q3D versus Q1D.|Mixed Models Analysis|||||7.16|-4.32|0.626
72575249|NCT02792699|144676506|OTHER||Risk Ratio (RR)|1.112|||||TWO_SIDED|90.0|0.6722|1.8398||||||Risk ratio (ABP 798/ABP 798 versus Rituximab \[US\]/ABP 798\]) at week 24, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||1.8398|0.6722|
72538909|NCT01215955|144607445|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.48||||0.358|TWO_SIDED|95.0|-10.91|3.95||P-value is for Midday 2-Hr PP. No imputation was performed. Participants without a 24-week value were handled by the statistical model. Comparison is calculated as Q3D versus Q1D.|Mixed Models Analysis|||||3.95|-10.91|0.358
72538910|NCT01215955|144607445|SUPERIORITY_OR_OTHER||LS Mean Difference|3.38||||0.322|TWO_SIDED|95.0|-3.32|10.07||P-value is for Evening Pre-meal. No imputation was performed. Participants without a 24-week value were handled by the statistical model. Comparison is calculated as Q3D versus Q1D.|Mixed Models Analysis|||||10.07|-3.32|0.322
72575250|NCT02792699|144676506|OTHER||Risk Difference (RD)|0.0244|||||TWO_SIDED|90.0|-0.063|0.1119||||||Risk difference (ABP 798/ABP 798 - Rituximab \[US\]/ABP 798) at week 24, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||0.1119|-0.0630|
72538911|NCT01215955|144607445|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.25||||0.617|TWO_SIDED|95.0|-11.08|6.58||P-value is for Bed Time. No imputation was performed. Participants without a 24-week value were handled by the statistical model. Comparison is calculated as Q3D versus Q1D.|Mixed Models Analysis|||||6.58|-11.08|0.617
72538912|NCT01215955|144607445|SUPERIORITY_OR_OTHER||LS Mean Difference|2.37||||0.519|TWO_SIDED|95.0|-4.86|9.6||P-value is for 0300 hours. No imputation was performed. Participants without a 24-week value were handled by the statistical model. Comparison is calculated as Q3D versus Q1D.|Mixed Models Analysis|||||9.60|-4.86|0.519
72538913|NCT01215955|144607445|SUPERIORITY_OR_OTHER||LS Mean Difference|2.1||||0.415|TWO_SIDED|95.0|-2.96|7.15||P-value is for Morning Pre-meal. No imputation was performed. Participants without a 24-week value were handled by the statistical model. Comparison is calculated as Q3D versus Q1D.|Mixed Models Analysis|||||7.15|-2.96|0.415
72538914|NCT01215955|144607445|SUPERIORITY_OR_OTHER||LS Mean Difference|4.38||||0.198|TWO_SIDED|95.0|-2.3|11.06||P-value is for Morning 2-hr PP. No imputation was performed. Participants without a 24-week value were handled by the statistical model. Comparison is calculated as Q3D versus Q1D.|Mixed Models Analysis|||||11.06|-2.30|0.198
72538915|NCT01215955|144607445|SUPERIORITY_OR_OTHER||LS Mean Difference|6.22||||0.045|TWO_SIDED|95.0|0.14|12.29||P-value is for Midday Pre-Meal. No imputation was performed. Participants without a 24-week value were handled by the statistical model. Comparison is calculated as Q3D versus Q1D.|Mixed Models Analysis|||||12.29|0.14|0.045
72538916|NCT01215955|144607445|SUPERIORITY_OR_OTHER||LS Mean Difference|3.07||||0.426|TWO_SIDED|95.0|-4.5|10.64||P-value is for Midday 2-hr PP. No imputation was performed. Participants without a 24-week value were handled by the statistical model. Comparison is calculated as Q3D versus Q1D.|Mixed Models Analysis|||||10.64|-4.50|0.426
72538917|NCT01215955|144607445|SUPERIORITY_OR_OTHER||LS Mean Difference|5.66||||0.14|TWO_SIDED|95.0|-1.86|13.17||P-value is for Evening Pre-Meal. No imputation was performed. Participants without a 24-week value were handled by the statistical model. Comparison is calculated as Q3D versus Q1D.|Mixed Models Analysis|||||13.17|-1.86|0.140
72538918|NCT01215955|144607445|SUPERIORITY_OR_OTHER||LS Mean Difference|11.18||||0.02|TWO_SIDED|95.0|1.74|20.63||P-value is for Bed Time. No imputation was performed. Participants without a 24-week value were handled by the statistical model. Comparison is calculated as Q3D versus Q1D.|Mixed Models Analysis|||||20.63|1.74|0.020
72538919|NCT01215955|144607445|SUPERIORITY_OR_OTHER||LS Mean Difference|9.01||||0.037|TWO_SIDED|95.0|0.53|17.49||P-value is for 0300 hours. No imputation was performed. Participants without a 24-week value were handled by the statistical model. Comparison is calculated as Q3D versus Q1D.|Mixed Models Analysis|||||17.49|0.53|0.037
72538920|NCT01215955|144607446|SUPERIORITY_OR_OTHER||LS Mean Difference|1.15||||0.543|TWO_SIDED|95.0|-2.55|4.84||P-value is for basal insulin dose. No imputation was performed. Participants without a 24-week value were handled by the statistical model. Comparison is calculated as Q3D versus Q1D.|Mixed Models Analysis|||||4.84|-2.55|0.543
72538921|NCT01215955|144607446|SUPERIORITY_OR_OTHER||LS Mean Difference|6.72||||0.095|TWO_SIDED|95.0|-1.17|14.6||P-value is for bolus insulin dose. No imputation was performed. Participants without a 24-week value were handled by the statistical model. Comparison is calculated as Q3D versus Q1D.|Mixed Models Analysis|||||14.60|-1.17|0.095
72538922|NCT01215955|144607446|SUPERIORITY_OR_OTHER||LS Mean Difference|8.86||||0.059|TWO_SIDED|95.0|-0.35|18.06||P-value is for total insulin dose. No imputation was performed. Participants without a 24-week value were handled by the statistical model. Comparison is calculated as Q3D versus Q1D.|Mixed Models Analysis|||||18.06|-0.35|0.059
72538923|NCT01215955|144607446|SUPERIORITY_OR_OTHER||LS Mean Difference|1.09||||0.497|TWO_SIDED|95.0|-2.05|4.23||P-value is for basal insulin dose. No imputation was performed. Participants without a 24-week value were handled by the statistical model. Comparison is calculated as Q3D versus Q1D.|Mixed Models Analysis|||||4.23|-2.05|0.497
72538924|NCT01215955|144607446|SUPERIORITY_OR_OTHER||LS Mean Difference|5.37||||0.156|TWO_SIDED|95.0|-2.06|12.79||P-value is for bolus insulin dose. No imputation was performed. Participants without a 24-week value were handled by the statistical model. Comparison is calculated as Q3D versus Q1D.|Mixed Models Analysis|||||12.79|-2.06|0.156
72538925|NCT01215955|144607446|SUPERIORITY_OR_OTHER||LS Mean Difference|6.05||||0.222|TWO_SIDED|95.0|-3.67|15.76||P-value of for total insulin dose. No imputation was performed. Participants without a 24-week value were handled by the statistical model. Comparison is calculated as Q3D versus Q1D.|Mixed Models Analysis|||||15.76|-3.67|0.222
72538926|NCT01215955|144607447|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01||||0.442|TWO_SIDED|95.0|-0.02|0.05||P-value is for basal insulin dose. No imputation was performed. Participants without a 24-week value were handled by the statistical model. Comparison is calculated as Q3D versus Q1D.|LS Mean Difference|||||0.05|-0.02|0.442
72538927|NCT01215955|144607447|SUPERIORITY_OR_OTHER||LS Mean Difference|0.07||||0.037|TWO_SIDED|95.0|0.0|0.14||P-value is for bolus insulin dose. No imputation was performed. Participants without a 24-week value were handled by the statistical model. Comparison is calculated as Q3D versus Q1D.|Mixed Models Analysis|||||0.14|0.00|0.037
72538928|NCT01215955|144607447|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1|||<|0.001|TWO_SIDED|95.0|0.05|0.16||P-value is for total insulin dose. No imputation was performed. Participants without a 24-week value were handled by the statistical model. Comparison is calculated as Q3D versus Q1D.|Mixed Models Analysis|||||0.16|0.05|<0.001
72538929|NCT01215955|144607447|SUPERIORITY_OR_OTHER||LS Mean Difference|0.02||||0.275|TWO_SIDED|95.0|-0.01|0.05||P-value is for basal insulin dose. No imputation was performed. Participants without a 24-week value were handled by the statistical model. Comparison is calculated as Q3D versus Q1D.|LS Mean Difference|||||0.05|-0.01|0.275
72538930|NCT01215955|144607447|SUPERIORITY_OR_OTHER||LS Mean Difference|0.03||||0.194|TWO_SIDED|95.0|-0.02|0.08||P-value is for bolus insulin dose. No imputation was performed. Participants without a 24-week value were handled by the statistical model. Comparison is calculated as Q3D versus Q1D.|Mixed Models Analysis|||||0.08|-0.02|0.194
72538931|NCT01215955|144607447|SUPERIORITY_OR_OTHER||LS Mean Difference|0.06||||0.245|TWO_SIDED|95.0|-0.04|0.15||P-value is for total insulin dose. No imputation was performed. Participants without a 24-week value were handled by the statistical model. Comparison is calculated as Q3D versus Q1D.|Mixed Models Analysis|||||0.15|-0.04|0.245
72538932|NCT01215955|144607448|SUPERIORITY_OR_OTHER|||||||0.435||95.0||||Comparison is calculated as Q3D versus Q1D.|Regression, Logistic|||||||0.435
72538933|NCT01215955|144607448|SUPERIORITY_OR_OTHER|||||||0.351||95.0||||Comparison is calculated as Q3D versus Q1D.|Regression, Logistic|||||||0.351
72538934|NCT01215955|144607449|SUPERIORITY_OR_OTHER|||||||0.802||95.0||||Comparison is calculated as Q3D versus Q1D.|Regression, Logistic|||||||0.802
72538935|NCT01215955|144607449|SUPERIORITY_OR_OTHER|||||||0.205||95.0||||Comparison is calculated as Q3D versus Q1D.|Regression, Logistic|||||||0.205
72538936|NCT01215955|144607450|SUPERIORITY_OR_OTHER||Q3D vs Q1D Ratio of Negative Binomial|1.06||||0.586|TWO_SIDED|95.0|0.86|1.3||Comparison is calculated as Q3D versus Q1D.|Negative Binomial Regression|||||1.30|0.86|0.586
72409679|NCT00807092|144327727|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.02|STANDARD_ERROR_OF_MEAN|0.113||0.8598||95.0|-0.243|0.243||A statistical significant threshold p\<0.05|ANCOVA|Treatment and strata as factors; baseline (week 0) value of HbA1c as covariate||"The null hypothesis (H0) was:~H0: Change in HbA1c of BIAsp 30 after 6 weeks of treatment-Change in HbA1c of BHI 30 after 6 weeks of treatment =0 % against the alternative hypothesis(H1): H1: Change in HbA1c of BIAsp 30 after 6 weeks of treatment-Change in HbA1c of BHI 30 after 6 weeks of treatment≠0%"||0.243|-0.243|0.8598
72409680|NCT00807092|144327728|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.054|STANDARD_ERROR_OF_MEAN|0.128||0.671||95.0|-0.307|0.198||A statistical significant threshold p\<0.05|ANCOVA|Treatment and strata as factors; baseline (week 0) value of duration of hypoglycaemic events as covariate|Blood glucose below 3.5 mmol/l|"The null hypothesis (H0) was:~H0: Duration of Hypoglycaemic Events Based on CGMS of BIAsp 30 after 6 weeks of treatment-Duration of Hypoglycaemic Events Based on CGMS of BHI 30 after 6 weeks of treatment =0 hours against the alternative hypothesis(H1): H1: Duration of Hypoglycaemic Events Based on CGMS of BIAsp 30 after 6 weeks of treatment-Duration of Hypoglycaemic Events Based on CGMS of BHI 30 after 6 weeks of treatment≠0 hours"||0.198|-0.307|0.671
72538937|NCT01215955|144607450|SUPERIORITY_OR_OTHER||Q3D vs Q1D Ratio Negative Binomial|1.05||||0.689|TWO_SIDED|95.0|0.84|1.3||Comparison is calculated as Q3D versus Q1D.|Negative Binomial|||||1.30|0.84|0.689
72538938|NCT01215955|144607451|SUPERIORITY_OR_OTHER|||||||0.258||95.0||||Comparison is calculated as Q3D versus Q1D.|Regression, Logistic|||||||0.258
72538939|NCT01215955|144607451|SUPERIORITY_OR_OTHER|||||||0.856||95.0||||Comparison is calculated as Q3D versus Q1D.|Regression, Logistic|||||||0.856
72538940|NCT01523301|144607452|SUPERIORITY_OR_OTHER||Difference in LS Mean|-1.12|||=|0.1286|TWO_SIDED|95.0|-2.56|0.33||The null hypothesis was assessed with a 2-sided test and not rejected at p≤0.05.|ANCOVA|||The change from Baseline to the end of the Maintenance period in the score of the HAM-D of rotigotine-treated subjects has been compared with those subjects on placebo in the EES. The null hypothesis (H0) was that there was no difference in the change of the HAM-D score between the active treatment and the placebo group. The alternative hypothesis (H1) was that there was a difference in the change of HAM-D score between the rotigotine and the placebo arm.||0.33|-2.56|=0.1286
72538941|NCT01447628|144607459|SUPERIORITY|||||||0.6039|||||||Mixed Models Analysis|||||||0.6039
72538942|NCT01447628|144607460|SUPERIORITY|||||||0.0747|||||||Mixed Models Analysis|||||||0.0747
72538943|NCT01447628|144607460|SUPERIORITY|||||||0.799|||||||Mixed Models Analysis|||||||0.7990
72538944|NCT01447628|144607460|SUPERIORITY|||||||0.2111|||||||Mixed Models Analysis|||This is a combination of the p-values from the separate analyses of each data set.||||0.2111
72538945|NCT01447628|144607461|SUPERIORITY|||||||0.6583|||||||Mixed Models Analysis|||||||0.6583
72538946|NCT01447628|144607461|SUPERIORITY|||||||0.9166|||||||Mixed Models Analysis|||||||0.9166
72538947|NCT01447628|144607461|SUPERIORITY|||||||0.6631|||||||Mixed Models Analysis|||||||0.6631
72538948|NCT01447628|144607462|SUPERIORITY|||||||0.4039|||||||Mixed Models Analysis|||||||0.4039
72538949|NCT01447628|144607462|SUPERIORITY|||||||0.9144|||||||Mixed Models Analysis|||||||0.9144
72538950|NCT01447628|144607462|SUPERIORITY|||||||0.9959|||||||Mixed Models Analysis|||||||0.9959
72538951|NCT01447628|144607463|SUPERIORITY|||||||0.1788|||||||Mixed Models Analysis|||||||0.1788
72538952|NCT01447628|144607463|SUPERIORITY|||||||0.7795|||||||Mixed Models Analysis|||||||0.7795
72538953|NCT01447628|144607463|SUPERIORITY|||||||0.414|||||||Mixed Models Analysis|||||||0.414
72538954|NCT01447628|144607464|SUPERIORITY|||||||0.8688|||||||Mixed Models Analysis|||||||0.8688
72538955|NCT01447628|144607464|SUPERIORITY|||||||0.9999|||||||Mixed Models Analysis|||||||0.9999
72538956|NCT01447628|144607464|SUPERIORITY|||||||0.991|||||||Mixed Models Analysis|||||||0.991
72538957|NCT01447628|144607465|SUPERIORITY|||||||0.5465|||||||Mixed Models Analysis|||||||0.5465
72538958|NCT01447628|144607465|SUPERIORITY|||||||0.4298|||||||Mixed Models Analysis|||||||0.4298
72538959|NCT01447628|144607465|SUPERIORITY|||||||0.5451|||||||Mixed Models Analysis|||||||0.5451
72538960|NCT01447628|144607466|SUPERIORITY|||||||0.6241|||||||Mixed Models Analysis|||Note that Endurance CPET was not done in China, hence only European data provided.||||0.6241
72538961|NCT01447628|144607467|SUPERIORITY|||||||0.4758|||||||Mixed Models Analysis|||||||0.4758
72538962|NCT01447628|144607468|SUPERIORITY|||||||0.205|||||||Mixed Models Analysis|||||||0.2050
72538963|NCT01447628|144607468|SUPERIORITY|||||||0.1993|||||||Mixed Models Analysis|||||||0.1993
72538964|NCT01447628|144607468|SUPERIORITY|||||||0.1993|||||||Mixed Models Analysis|||||||0.1993
72538965|NCT01447628|144607469|SUPERIORITY|||||||0.061|||||||Mixed Models Analysis|||||||0.0610
72538966|NCT01447628|144607469|SUPERIORITY|||||||0.0641|||||||Mixed Models Analysis|||||||0.0641
72538967|NCT01447628|144607470|SUPERIORITY|||||||0.0003|||||||Mixed Models Analysis|||||||0.0003
72538968|NCT01447628|144607470|SUPERIORITY|||||||0.0001|||||||Mixed Models Analysis|||||||0.0001
72538969|NCT01447628|144607470|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||||||<0.0001
72538970|NCT01447628|144607471|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||||||<0.0001
72538971|NCT01447628|144607472|SUPERIORITY|||||||0.8093|||||||Mixed Models Analysis|||||||0.8093
72538972|NCT01447628|144607472|SUPERIORITY|||||||0.63|||||||Mixed Models Analysis|||||||0.6300
72538973|NCT01447628|144607472|SUPERIORITY|||||||0.8533|||||||Mixed Models Analysis|||||||0.8533
72538974|NCT01447628|144607473|SUPERIORITY|||||||0.0725|||||||Mixed Models Analysis|||||||0.0725
72538975|NCT01447628|144607473|SUPERIORITY|||||||0.8572|||||||Mixed Models Analysis|||||||0.8572
72538976|NCT01447628|144607473|SUPERIORITY|||||||0.2348|||||||Mixed Models Analysis|||||||0.2348
72538977|NCT01447628|144607474|SUPERIORITY|||||||0.1115|||||||Mixed Models Analysis|||||||0.1115
72538978|NCT01447628|144607475|SUPERIORITY|||||||0.979|||||||Mixed Models Analysis|||||||0.9790
72538979|NCT01447628|144607476|SUPERIORITY|||||||0.7702|||||||Mixed Models Analysis|||||||0.7702
72538980|NCT01447628|144607477|SUPERIORITY|||||||0.2219|||||||Mixed Models Analysis|||||||0.2219
72538981|NCT01447628|144607478|SUPERIORITY|||||||0.1777|||||||Mixed Models Analysis|||||||0.1777
72538982|NCT01447628|144607478|SUPERIORITY|||||||0.7889|||||||Mixed Models Analysis|||||||0.7889
72538983|NCT01447628|144607478|SUPERIORITY|||||||0.4156|||||||Mixed Models Analysis|||||||0.4156
72538984|NCT01447628|144607479|SUPERIORITY|||||||0.7625|||||||Mixed Models Analysis|||||||0.7625
72538985|NCT01447628|144607479|SUPERIORITY|||||||0.2262|||||||Mixed Models Analysis|||||||0.2262
72538986|NCT01447628|144607479|SUPERIORITY|||||||0.4756|||||||Mixed Models Analysis|||||||0.4756
72538987|NCT01447628|144607480|SUPERIORITY|||||||0.7711|||||||Mixed Models Analysis|||||||0.7711
72538988|NCT01447628|144607480|SUPERIORITY|||||||0.7806|||||||Mixed Models Analysis|||||||0.7806
72538989|NCT01447628|144607480|SUPERIORITY|||||||0.9074|||||||Mixed Models Analysis|||||||0.9074
72575251|NCT02792699|144676506|OTHER||Risk Ratio (RR)|0.9798|||||TWO_SIDED|90.0|0.6675|1.4384||||||Risk ratio (ABP 798/ABP 798 versus Rituximab \[EU\]/Rituximab \[EU\]) at week 40, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||1.4384|0.6675|
72575252|NCT02792699|144676506|OTHER||Risk Difference (RD)|0.0375|||||TWO_SIDED|90.0|-0.0707|0.1456||||||Risk difference (ABP 798/ABP 798 - Rituximab \[EU\]/Rituximab \[EU\]) at week 40, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||0.1456|-0.0707|
72575253|NCT02792699|144676506|OTHER||Risk Ratio (RR)|1.1831|||||TWO_SIDED|90.0|0.7833|1.787||||||Risk ratio (ABP 798/ABP 798 versus Rituximab \[US\]/ABP 798\]) at week 40, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||1.7870|0.7833|
72575254|NCT02792699|144676506|OTHER||Risk Difference (RD)|0.0752|||||TWO_SIDED|90.0|-0.0297|0.1802||||||Risk difference (ABP 798/ABP 798 - Rituximab \[US\]/ABP 798) at week 40, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||0.1802|-0.0297|
72538990|NCT01447628|144607481|SUPERIORITY|||||||0.9504|||||||Mixed Models Analysis|||||||0.9504
72538991|NCT01447628|144607481|SUPERIORITY|||||||0.8666|||||||Mixed Models Analysis|||||||0.8666
72538992|NCT01447628|144607481|SUPERIORITY|||||||0.8104|||||||Mixed Models Analysis|||||||0.8104
72538993|NCT01447628|144607482|SUPERIORITY|||||||0.4478|||||||Mixed Models Analysis|||||||0.4478
72538994|NCT01447628|144607483|SUPERIORITY|||||||0.459|||||||Mixed Models Analysis|||||||0.4590
72538995|NCT01447628|144607484|SUPERIORITY|||||||0.8086|||||||Mixed Models Analysis|||||||0.8086
72538996|NCT01447628|144607485|SUPERIORITY|||||||0.6944|||||||Mixed Models Analysis|||||||0.6944
72538997|NCT01447628|144607486|SUPERIORITY|||||||0.585|||||||Mixed Models Analysis|||||||0.585
72538998|NCT01447628|144607487|SUPERIORITY|||||||0.4619|||||||Mixed Models Analysis|||||||0.4619
72538999|NCT01447628|144607488|SUPERIORITY|||||||0.7721|||||||Mixed Models Analysis|||||||0.7721
72539000|NCT01447628|144607489|SUPERIORITY|||||||0.8332|||||||Mixed Models Analysis|||||||0.8332
72539001|NCT01447628|144607490|SUPERIORITY|||||||0.2651|||||||Mixed Models Analysis|||||||0.2651
72539002|NCT00396981|144607500|NON_INFERIORITY_OR_EQUIVALENCE|This study used a non-inferiority design to demonstrate that the Matrix Coil is non-inferior to the GDC Coil, with a clinically acceptable non-inferiority margin set at 10%. Non-inferiority was used to establish the baseline estimate, which future superiority studies could be conducted. Non-inferiority was shown with a one-sided 95% CI of the difference less than the pre-specified 10% margin||||||0.76|||||||Log Rank|||Intent-to-Treat, All Subjects (N=626) GDC (N=315) Matrix (N=311) All Subjects (N=626) Subjects Who Met Primary Endpoint 35 (11.1%) 34 (10.9%) 69 (11.0%)||||0.76
72539003|NCT00639158|144607507|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The treatment group comparisons for both primary efficacy variables must have demonstrated superiority of ABT-335 + atorvastatin + ezetimibe to declare this arm successful. Thus, no adjustments were made for multiple comparisons.|Wilcoxon (Mann-Whitney)|||A sample size of 212 per arm provided 90% power and \> 99% power with a 2-sided alpha = 0.05 level to detect differences between treatment arms of 6% and 17% in the percent change in HDL-C and TG, respectively, assuming an SD of 19% and 30%, respectively. This sample size provided an overall power of approximately 90% for the 2 primary comparisons. If a loss to follow-up rate of 8% was assumed, the sample size needed to be increased to 230 per arm to maintain the above power.||||< 0.001
72539004|NCT00639158|144607508|SUPERIORITY_OR_OTHER|||||||0.004||95.0|||||ANCOVA|Corresponding baseline lipid value as the covariate and with effect for treatment group.||Secondary endpoints were tested in fixed sequence. If superiority of ABT-335 + atorvastatin + ezetimibe treatment was demonstrated for primary endpoints, secondary endpoints were tested in ranked order of apoA1, VLDL-C, apoC3, non-HDL-C, apoB, and hsCRP at alpha = 0.05 level until 1 secondary endpoint failed to reach statistical significance.||||0.004
72575255|NCT02792699|144676506|OTHER||Risk Ratio (RR)|0.7027|||||TWO_SIDED|90.0|0.493|1.0017||||||Risk ratio (ABP 798/ABP 798 versus Rituximab \[EU\]/Rituximab \[EU\]) at week 48, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||1.0017|0.4930|
72575256|NCT02792699|144676506|OTHER||Risk Difference (RD)|-0.0908|||||TWO_SIDED|90.0|-0.211|0.0294||||||Risk difference (ABP 798/ABP 798 - Rituximab \[EU\]/Rituximab \[EU\]) at week 48, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||0.0294|-0.2110|
72575257|NCT02792699|144676506|OTHER||Risk Ratio (RR)|1.1449|||||TWO_SIDED|90.0|0.7601|1.7246||||||Risk ratio (ABP 798/ABP 798 versus Rituximab \[US\]/ABP 798\]) at week 48, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||1.7246|0.7601|
72575258|NCT02792699|144676506|OTHER||Risk Difference (RD)|0.0277|||||TWO_SIDED|90.0|-0.0804|0.1357||||||Risk difference (ABP 798/ABP 798 - Rituximab \[US\]/ABP 798) at week 48, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||0.1357|-0.0804|
72575259|NCT02792699|144676507|OTHER||LS Mean Difference|-1.999|||||TWO_SIDED|90.0|-7.673|3.675||||||Analysis of the LS mean difference (ABP 798/ABP 798 - Rituximab \[EU\]/Rituximab \[EU\]) at week 8, based on an ANCOVA model adjusted for the stratification variables geographic region, seropositivity, and number of prior biologic therapies used for RA.||3.675|-7.673|
72539005|NCT00639158|144607509|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The treatment group comparisons for both primary efficacy variables must have demonstrated superiority of ABT-335 + atorvastatin + ezetimibe to declare this arm successful. Thus, no adjustments were made for multiple comparisons.|ANCOVA|Corresponding baseline lipid value as the covariate and with effect for treatment group.||A sample size of 212 per arm provided 90% power and \> 99% power with a 2-sided alpha = 0.05 level to detect differences between treatment arms of 6% and 17% in the percent change in HDL-C and TG, respectively, assuming an SD of 19% and 30%, respectively. This sample size provided an overall power of approximately 90% for the 2 primary comparisons. If a loss to follow-up rate of 8% was assumed, the sample size needed to be increased to 230 per arm to maintain the above power.||||< 0.001
72539006|NCT00639158|144607510|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|Corresponding baseline lipid value as the covariate and with effect for treatment group.||Secondary endpoints were tested in fixed sequence. If superiority of ABT-335 + atorvastatin + ezetimibe treatment was demonstrated for primary endpoints, secondary endpoints were tested in ranked order of apoA1, VLDL-C, apoC3, non-HDL-C, apoB, and hsCRP at alpha = 0.05 level until 1 secondary endpoint failed to reach statistical significance.||||< 0.001
72539007|NCT00639158|144607511|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|Corresponding lipid value as the covariate and with effect for treatment group.||Secondary endpoints were tested in fixed sequence. If superiority of ABT-335 + atorvastatin + ezetimibe treatment was demonstrated for primary endpoints, secondary endpoints were tested in ranked order of apoA1, VLDL-C, apoC3, non-HDL-C, apoB, and hsCRP at alpha = 0.05 level until 1 secondary endpoint failed to reach statistical significance.||||< 0.001
72539008|NCT00639158|144607512|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|Corresponding baseline lipid value as the covariate and with effect for treatment group.||Secondary endpoints were tested in fixed sequence. If superiority of ABT-335 + atorvastatin + ezetimibe treatment was demonstrated for primary endpoints, secondary endpoints were tested in ranked order of apoA1, VLDL-C, apoC3, non-HDL-C, apoB, and hsCRP at alpha = 0.05 level until 1 secondary endpoint failed to reach statistical significance.||||< 0.001
72539009|NCT00639158|144607513|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|Corresponding baseline lipid value as the covariate and with effect for treatment group.||Secondary endpoints were tested in fixed sequence. If superiority of ABT-335 + atorvastatin + ezetimibe treatment was demonstrated for primary endpoints, secondary endpoints were tested in ranked order of apoA1, VLDL-C, apoC3, non-HDL-C, apoB, and hsCRP at alpha = 0.05 level until 1 secondary endpoint failed to reach statistical significance.||||< 0.001
72539010|NCT00639158|144607514|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon (Mann-Whitney)|Rank-sum test||Secondary endpoints were tested in fixed sequence. If superiority of ABT-335 + atorvastatin + ezetimibe treatment was demonstrated for primary endpoints, secondary endpoints were tested in ranked order of apoA1, VLDL-C, apoC3, non-HDL-C, apoB, and hsCRP at alpha = 0.05 level until 1 secondary endpoint failed to reach statistical significance.||||< 0.001
72539011|NCT01787188|144607523|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-10.84|STANDARD_ERROR_OF_MEAN|3.097||0.0005|TWO_SIDED|95.0|-16.93|-4.75|||Mixed Models Analysis|||||-4.75|-16.93|0.0005
72539012|NCT01787188|144607523|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-8.74|STANDARD_ERROR_OF_MEAN|3.154||0.0059|TWO_SIDED|95.0|-14.94|-2.53|||Mixed Models Analysis|||||-2.53|-14.94|0.0059
72539013|NCT01787188|144607524|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-9.61|STANDARD_ERROR_OF_MEAN|2.641||0.0003|TWO_SIDED|95.0|-14.8|-4.42|||Mixed Models Analysis|||||-4.42|-14.80|0.0003
72575260|NCT02792699|144676507|OTHER||LS Mean Difference|0.544|||||TWO_SIDED|90.0|-5.185|6.274||||||Analysis of the LS mean difference (ABP 798/ABP 798 - Rituximab \[US\]/ABP 798) at week 8, based on an ANCOVA model adjusted for the stratification variables geographic region, seropositivity, and number of prior biologic therapies used for RA.||6.274|-5.185|
72575261|NCT02792699|144676507|OTHER||LS Mean Difference|-8.224|||||TWO_SIDED|90.0|-14.102|-2.346||||||Analysis of the LS mean difference (ABP 798/ABP 798 - Rituximab \[EU\]/Rituximab \[EU\]) at week 12, based on an ANCOVA model adjusted for the stratification variables geographic region, seropositivity, and number of prior biologic therapies used for RA.||-2.346|-14.102|
72575262|NCT02792699|144676507|OTHER||LS Mean Difference|-2.06|||||TWO_SIDED|90.0|-8.052|3.933||||||Analysis of the LS mean difference (ABP 798/ABP 798 - Rituximab \[US\]/ABP 798) at week 12, based on an ANCOVA model adjusted for the stratification variables geographic region, seropositivity, and number of prior biologic therapies used for RA.||3.933|-8.052|
72539014|NCT01787188|144607524|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-3.9|STANDARD_ERROR_OF_MEAN|2.696||0.1486|TWO_SIDED|95.0|-9.2|1.4|||Mixed Models Analysis|||||1.40|-9.20|0.1486
72575263|NCT02792699|144676507|OTHER||LS Mean Difference|-1.32|||||TWO_SIDED|90.0|-7.62|4.979||||||Analysis of the LS mean difference (ABP 798/ABP 798 - Rituximab \[EU\]/Rituximab \[EU\]) at week 24, based on an ANCOVA model adjusted for the stratification variables geographic region, seropositivity, and number of prior biologic therapies used for RA.||4.979|-7.620|
72539015|NCT01787188|144607525|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-10.33|STANDARD_ERROR_OF_MEAN|2.865||0.0004|TWO_SIDED|95.0|-15.97|-4.7|||Mixed Models Analysis|||||-4.70|-15.97|0.0004
72539016|NCT01787188|144607525|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-9.84|STANDARD_ERROR_OF_MEAN|2.917||0.0008|TWO_SIDED|95.0|-15.58|-4.1|||Mixed Models Analysis|||||-4.10|-15.58|0.0008
72539017|NCT01787188|144607526|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-10.44|STANDARD_ERROR_OF_MEAN|2.521|<|0.0001|TWO_SIDED|95.0|-15.4|-5.48|||ANCOVA|||||-5.48|-15.40|<0.0001
72539018|NCT01787188|144607526|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-7.82|STANDARD_ERROR_OF_MEAN|2.561||0.0024|TWO_SIDED|95.0|-12.85|-2.78|||ANCOVA|||||-2.78|-12.85|0.0024
72539019|NCT01787188|144607527|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-10.34|STANDARD_ERROR_OF_MEAN|2.623|<|0.0001|TWO_SIDED|95.0|-15.49|-5.18|||Mixed Models Analysis|||||-5.18|-15.49|<0.0001
72539020|NCT01787188|144607527|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-4.39|STANDARD_ERROR_OF_MEAN|2.662||0.0997|TWO_SIDED|95.0|-9.63|0.84|||Mixed Models Analysis|||||0.84|-9.63|0.0997
72575264|NCT02792699|144676507|OTHER||LS Mean Difference|0.73|||||TWO_SIDED|90.0|-5.691|7.15||||||Analysis of the LS mean difference (ABP 798/ABP 798 - Rituximab \[US\]/ABP 798) at week 24, based on an ANCOVA model adjusted for the stratification variables geographic region, seropositivity, and number of prior biologic therapies used for RA.||7.150|-5.691|
72539021|NCT01787188|144607528|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-9.83|STANDARD_ERROR_OF_MEAN|2.905||0.0008|TWO_SIDED|95.0|-15.54|-4.11|||Mixed Models Analysis|||||-4.11|-15.54|0.0008
72539022|NCT01787188|144607528|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-9.42|STANDARD_ERROR_OF_MEAN|2.951||0.0015|TWO_SIDED|95.0|-15.22|-3.62|||Mixed Models Analysis|||||-3.62|-15.22|0.0015
72539023|NCT01787188|144607529|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-10.13|STANDARD_ERROR_OF_MEAN|3.147||0.0014|TWO_SIDED|95.0|-16.32|-3.94|||Mixed Models Analysis|||||-3.94|-16.32|0.0014
72539024|NCT01787188|144607529|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-9.98|STANDARD_ERROR_OF_MEAN|3.198||0.0019|TWO_SIDED|95.0|-16.27|-3.69|||Mixed Models Analysis|||||-3.69|-16.27|0.0019
72539025|NCT01787188|144607530|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-10.47|STANDARD_ERROR_OF_MEAN|2.593|<|0.0001|TWO_SIDED|95.0|-15.57|-5.37|||ANCOVA|||||-5.37|-15.57|<0.0001
72539026|NCT01787188|144607530|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-8.16|STANDARD_ERROR_OF_MEAN|2.627||0.002|TWO_SIDED|95.0|-13.33|-2.99|||ANCOVA|||||-2.99|-13.33|0.0020
72539027|NCT01787188|144607531|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-10.45|STANDARD_ERROR_OF_MEAN|2.686||0.0001|TWO_SIDED|95.0|-15.73|-5.17|||Mixed Models Analysis|||||-5.17|-15.73|0.0001
72539028|NCT01787188|144607531|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-4.41|STANDARD_ERROR_OF_MEAN|2.725||0.1065|TWO_SIDED|95.0|-9.77|0.95|||Mixed Models Analysis|||||0.95|-9.77|0.1065
72539029|NCT01787188|144607532|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-9.68|STANDARD_ERROR_OF_MEAN|2.961||0.0012|TWO_SIDED|95.0|-15.5|-3.85|||Mixed Models Analysis|||||-3.85|-15.50|0.0012
72539030|NCT01787188|144607532|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-9.65|STANDARD_ERROR_OF_MEAN|3.006||0.0014|TWO_SIDED|95.0|-15.56|-3.74|||Mixed Models Analysis|||||-3.74|-15.56|0.0014
72539031|NCT01787188|144607533|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-10.26|STANDARD_ERROR_OF_MEAN|3.194||0.0014|TWO_SIDED|95.0|-16.54|-3.97|||Mixed Models Analysis|||||-3.97|-16.54|0.0014
72575265|NCT02792699|144676507|OTHER||LS Mean Difference|-2.207|||||TWO_SIDED|90.0|-8.562|1.417||||||Analysis of the LS mean difference (ABP 798/ABP 798 - Rituximab \[EU\]/Rituximab \[EU\]) at week 40, based on an ANCOVA model adjusted for the stratification variables geographic region, seropositivity, and number of prior biologic therapies used for RA.||1.417|-8.562|
72539032|NCT01787188|144607533|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-10.45|STANDARD_ERROR_OF_MEAN|3.24||0.0014|TWO_SIDED|95.0|-16.82|-4.08|||Mixed Models Analysis|||||-4.08|-16.82|0.0014
72575266|NCT02792699|144676507|OTHER||LS Mean Difference|-0.036|||||TWO_SIDED|90.0|-6.497|6.424||||||Analysis of the LS mean difference (ABP 798/ABP 798 - Rituximab \[US\]/ABP 798) at week 40, based on an ANCOVA model adjusted for the stratification variables geographic region, seropositivity, and number of prior biologic therapies used for RA.||6.424|-6.497|
72539033|NCT01787188|144607534|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-10.52|STANDARD_ERROR_OF_MEAN|2.646|<|0.0001|TWO_SIDED|95.0|-15.72|-5.31|||ANCOVA|||||-5.31|-15.72|<0.0001
72539034|NCT01787188|144607534|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-8.44|STANDARD_ERROR_OF_MEAN|2.68||0.0018|TWO_SIDED|95.0|-13.71|-3.17|||ANCOVA|||||-3.17|-13.71|0.0018
72539035|NCT01787188|144607535|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-10.98|STANDARD_ERROR_OF_MEAN|2.831||0.0001|TWO_SIDED|95.0|-16.55|-5.41|||Mixed Models Analysis|||||-5.41|-16.55|0.0001
72539036|NCT01787188|144607535|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-6.02|STANDARD_ERROR_OF_MEAN|2.89||0.0379|TWO_SIDED|95.0|-11.71|-0.34|||Mixed Models Analysis|||||-0.34|-11.71|0.0379
72539037|NCT01787188|144607536|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-12.22|STANDARD_ERROR_OF_MEAN|3.152||0.0001|TWO_SIDED|95.0|-18.42|-6.02|||Mixed Models Analysis|||||-6.02|-18.42|0.0001
72539038|NCT01787188|144607536|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-9.1|STANDARD_ERROR_OF_MEAN|3.21||0.0049|TWO_SIDED|95.0|-15.41|-2.78|||Mixed Models Analysis|||||-2.78|-15.41|0.0049
72539039|NCT01787188|144607537|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-10.94|STANDARD_ERROR_OF_MEAN|3.359||0.0012|TWO_SIDED|95.0|-17.55|-4.33|||Mixed Models Analysis|||||-4.33|-17.55|0.0012
72539040|NCT01787188|144607537|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-9.36|STANDARD_ERROR_OF_MEAN|3.422||0.0066|TWO_SIDED|95.0|-16.09|-2.63|||Mixed Models Analysis|||||-2.63|-16.09|0.0066
72539041|NCT01787188|144607538|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-11.67|STANDARD_ERROR_OF_MEAN|2.751|<|0.0001|TWO_SIDED|95.0|-17.08|-6.26|||ANCOVA|||||-6.26|-17.08|<0.0001
72539042|NCT01787188|144607538|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-8.24|STANDARD_ERROR_OF_MEAN|2.795||0.0034|TWO_SIDED|95.0|-13.74|-2.74|||ANCOVA|||||-2.74|-13.74|0.0034
72539043|NCT02756078|144607566|NON_INFERIORITY|A non-inferiority margin of -5 points was used. This margin is based on a 10% shift in the distribution of CLUE score.|Posterior Mean Difference|5.0|STANDARD_DEVIATION|1.796|||TWO_SIDED|98.0|1.3|8.73|||Bayesian hierarchical model|A 98% credible interval for the posterior mean difference was used to demonstrate non-inferiority between the senofilcon A and samfilcon A lenses.|Mean difference was calculated as Test (senofilcon A) minus Control (samfilcon A)|||8.73|1.30|
72539044|NCT02756078|144607567|NON_INFERIORITY|A non-inferiority margin of -5 points was used. This margin is based on a 10% shift in the distribution of CLUE score.|Posterior Mean Difference|13.7|STANDARD_DEVIATION|1.701|||TWO_SIDED|95.0|10.34|17.05|||Bayesian hierarchical model|A 95% credible interval for the posterior mean difference was used to demonstrate non-inferiority between the senofilcon A and samfilcon A lenses.|Mean difference was calculated as Test (senofilcon A) minus Control (samfilcon A)|||17.05|10.34|
72575267|NCT02792699|144676507|OTHER||LS Mean Difference|-6.629|||||TWO_SIDED|90.0|-13.455|0.197||||||Analysis of the LS mean difference (ABP 798/ABP 798 - Rituximab \[EU\]/Rituximab \[EU\]) at week 48, based on an ANCOVA model adjusted for the stratification variables geographic region, seropositivity, and number of prior biologic therapies used for RA.||0.197|-13.455|
72539045|NCT02756078|144607568|NON_INFERIORITY|A non-inferiority margin of -2 hour was used.|Posterior mean difference|-0.37|STANDARD_DEVIATION|0.313|||TWO_SIDED|95.0|-1.0|0.25|||Bayesian hierarchical model|A 95% credible interval for the posterior mean difference was used to demonstrate non-inferiority between the senofilcon A and samfilcon A lenses.|||Mean difference was calculated as senofilcon A minus samfilcon A.|0.25|-1.00|
72539046|NCT02756078|144607569|NON_INFERIORITY|A non-inferiority margin of -2 hour was used.|Posterior mean difference|-0.06|STANDARD_DEVIATION|0.107|||TWO_SIDED|95.0|-0.27|0.16|||Bayesian hierarchical model|A 95% credible interval for the posterior mean difference was used to demonstrate non-inferiority between the senofilcon A and samfilcon A lenses.|Mean difference was calculated as senofilcon A minus samfilcon A|||0.16|-0.27|
72539047|NCT02756078|144607570|NON_INFERIORITY|A non-inferiority margin of -2 hour was used.|Posterior mean difference|0.05|STANDARD_DEVIATION|0.261|||TWO_SIDED|95.0|-0.47|0.57|||Bayesian hierarchical model|A 95% credible interval for the posterior mean difference was used to demonstrate non-inferiority between the senofilcon A and samfilcon A lenses.|Mean difference was calculated as senofilcon A minus samfilcon A|||0.57|-0.47|
72539048|NCT02756078|144607571|NON_INFERIORITY|A non-inferiority margin of -2 hour was used.|Posterior mean difference|-0.05|STANDARD_DEVIATION|0.159|||TWO_SIDED|95.0|-0.36|0.26|||Bayesian hierarchical model|A 95% credible interval for the posterior mean difference was used to demonstrate non-inferiority between the senofilcon A and samfilcon A lenses.|Mean difference was calculated as senofilcon A minus samfilcon A.|||0.26|-0.36|
72539049|NCT02756078|144607572|NON_INFERIORITY|A non-inferiority margin of 0.67 was used.|Posterior odds ratio|1.35|STANDARD_DEVIATION|0.203|||TWO_SIDED|95.0|0.99|1.79|||Bayesian multinomial model|A 95% credible interval for the posterior odds ratio was used to demonstrate non-inferiority between the senofilcon A and samfilcon A lenses.|Odds ratio was calculated as senofilcon A over samfilcon A.|||1.79|0.99|
72539050|NCT02587117|144607607|SUPERIORITY_OR_OTHER|||||||0.004|TWO_SIDED|95.0|||||Mann Whitney test|||||||0.004
72539051|NCT02587117|144607608|SUPERIORITY_OR_OTHER|||||||0.224|TWO_SIDED|95.0|||||Mann Whitney test|||||||0.224
72539052|NCT03332212|144607655|OTHER||Mean Difference (Final Values)|-0.247|STANDARD_ERROR_OF_MEAN|0.164||0.1418|TWO_SIDED|95.0|-0.582|0.087|||ANOVA|||ANOVA on the PCr/ATP ratio absolute change using treatment (empagliflozin vs. placebo), history of diabetes (yes vs, no) and history of atrial fibrillation (yes vs no) as between subjects factor.||0.087|-0.582|0.1418
72539053|NCT03332212|144607655|OTHER||Mean Difference (Final Values)|-0.159|STANDARD_ERROR_OF_MEAN|0.213||0.465|TWO_SIDED|95.0|-0.604|0.286|||ANOVA|||ANOVA on the PCr/ATP ratio absolute change using treatment (empagliflozin vs. placebo), history of diabetes (yes vs, no) and history of atrial fibrillation (yes vs no) as between subjects factor.||0.286|-0.604|0.4650
72539054|NCT02392559|144607671|SUPERIORITY||treatment difference|-38.3|STANDARD_ERROR_OF_MEAN|3.66|<|0.0001|TWO_SIDED|95.0|-45.54|-31.06|||repeated measures model||Treatment difference uses placebo as the reference.|||-31.06|-45.54|< 0.0001
72539055|NCT02392559|144607671|SUPERIORITY||||||<|0.0001||||||Adjusted p-value based on a combination of sequential testing and the Hochberg procedure to control the overall significance level for all primary and secondary endpoints.|sequential testing/Hochberg procedure|Adjusted p-value is compared to 0.05 to determine statistical significance.||||||< 0.0001
72539056|NCT02392559|144607672|SUPERIORITY||treatment difference|-42.09|STANDARD_ERROR_OF_MEAN|3.17|<|0.0001|TWO_SIDED|95.0|-48.34|-35.83|||repeated measures model||Treatment difference uses placebo as the reference.|||-35.83|-48.34|< 0.0001
72539057|NCT02392559|144607672|SUPERIORITY||||||<|0.0001||||||Adjusted p-value based on a combination of sequential testing and the Hochberg procedure to control the overall significance level for all primary and secondary endpoints.|sequential testing/Hochberg procedure|Adjusted p-value is compared to 0.05 to determine statistical significance.||||||< 0.0001
72539058|NCT02392559|144607673|SUPERIORITY||treatment difference|-68.6|STANDARD_ERROR_OF_MEAN|7.3|<|0.0001|TWO_SIDED|95.0|-83.1|-54.0||Treatment difference uses placebo as the reference.|repeated measures model|||||-54.0|-83.1|< 0.0001
72539059|NCT02392559|144607673|SUPERIORITY||||||<|0.0001||||||Adjusted p-value based on a combination of sequential testing and the Hochberg procedure to control the overall significance level for all primary and secondary endpoints.|sequential testing/Hochberg procedure|Adjusted p-value is compared to 0.05 to determine statistical significance.||||||< 0.0001
72539060|NCT02392559|144607674|SUPERIORITY||treatment difference|-35.04|STANDARD_ERROR_OF_MEAN|3.41|<|0.0001|TWO_SIDED|95.0|-41.79|-28.3|||repeated measures model||Treatment difference uses placebo as the reference.|||-28.30|-41.79|< 0.0001
72539061|NCT02392559|144607674|SUPERIORITY||||||<|0.0001||||||Adjusted p-value based on a combination of sequential testing and the Hochberg procedure to control the overall significance level for all primary and secondary endpoints.|sequential testing/Hochberg procedure|Adjusted p-value is compared to 0.05 to determine statistical significance.||||||< 0.0001
72539062|NCT02392559|144607675|SUPERIORITY||treatment difference|-32.47|STANDARD_ERROR_OF_MEAN|3.21|<|0.0001|TWO_SIDED|95.0|-38.82|-26.13|||repeated measures model||Treatment difference uses placebo as the reference.|||-26.13|-38.82|< 0.0001
72539063|NCT02392559|144607675|SUPERIORITY||||||<|0.0001||||||Adjusted p-value based on a combination of sequential testing and the Hochberg procedure to control the overall significance level for all primary and secondary endpoints.|sequential testing/Hochberg procedure|Adjusted p-value is compared to 0.05 to determine statistical significance.||||||< 0.0001
72539064|NCT02392559|144607676|SUPERIORITY||treatment difference|-30.3|STANDARD_ERROR_OF_MEAN|3.09|<|0.0001|TWO_SIDED|95.0|-36.4|-24.21|||repeated measures model||Treatment difference uses placebo as the reference.|||-24.21|-36.40|< 0.0001
72539065|NCT02392559|144607676|SUPERIORITY||||||<|0.0001||||||Adjusted p-value based on a combination of sequential testing and the Hochberg procedure to control the overall significance level for all primary and secondary endpoints.|sequential testing/Hochberg procedure|Adjusted p-value is compared to 0.05 to determine statistical significance.||||||< 0.0001
72539066|NCT02392559|144607677|SUPERIORITY||treatment difference|-36.38|STANDARD_ERROR_OF_MEAN|3.33|<|0.0001|TWO_SIDED|95.0|-42.97|-29.8|||repeated measures model||Treatment difference uses placebo as the reference.|||-29.80|-42.97|< 0.0001
72539067|NCT02392559|144607677|SUPERIORITY||||||<|0.0001||||||Adjusted p-value based on a combination of sequential testing and the Hochberg procedure to control the overall significance level for all primary and secondary endpoints.|sequential testing/Hochberg procedure|Adjusted p-value is compared to 0.05 to determine statistical significance.||||||< 0.0001
72539068|NCT02149199|144607783|SUPERIORITY||Odds Ratio (OR)|1.14||||0.046|TWO_SIDED|95.0|1.0|1.3|||Regression, Logistic|Repeated measures logistic regression, with treatment, pre-study treatment, region and study week as fixed effects.|An odds ratio greater than 1 favours Symbicort 'as needed'|||1.30|1.00|0.046
72539069|NCT02149199|144607783|NON_INFERIORITY|Non-inferiority analysis based on CI instead of p-value, hence no p-value calculated for this analysis. Lower limit of the 2-sided 95% CI \>=0.8 indicates Symbicort 'as needed' is non-inferior to Pulmicort bid.|Odds Ratio (OR)|0.64|||||TWO_SIDED|95.0|0.57|0.73|||Regression, Logistic|Repeated measures logistic regression with treatment, pre-study treatment, region and study week as fixed effects.||||0.73|0.57|
72539070|NCT02149199|144607784|SUPERIORITY||Hazard Ratio (HR)|0.435|||<|0.001|TWO_SIDED|95.0|0.328|0.577|||Regression, Cox|Cox-regression model with randomised treatment, pre-study treatment, severe exacerbations in the last 12 months (0, \>=1) and region as covariates.|A hazard ratio less than 1 indicates that Symbicort 'as needed' prolongs the time to first severe exacerbation.|||0.577|0.328|<0.001
72539071|NCT02149199|144607784|SUPERIORITY||Hazard Ratio (HR)|0.901||||0.524|TWO_SIDED|95.0|0.653|1.242|||Regression, Cox|Cox regression model with randomised treatment, pre-study treatment, severe exacerbations in the last 12 months (0,\>=1) and region as covariates.|A hazard ratio less than 1 indicates that Symbicort 'as needed' prolongs the time to first severe exacerbation.|||1.242|0.653|0.524
72539072|NCT02149199|144607785|SUPERIORITY||Hazard Ratio (HR)|0.429|||<|0.001|TWO_SIDED|95.0|0.348|0.528|||Regression, Cox|Cox regression model with randomised treatment, pre-study treatment, severe exacerbations in the last 12 months (0,\>=1) and region as covariates.|A hazard ratio less than 1 indicates that Symbicort 'as needed' prolongs the time to first moderate or severe exacerbation.|||0.528|0.348|<0.001
72539073|NCT02149199|144607785|SUPERIORITY||Hazard Ratio (HR)|0.91||||0.436|TWO_SIDED|95.0|0.718|1.153|||Regression, Cox|Cox regression model with randomised treatment, pre-study treatment, severe exacerbations in the last 12 months (0,\>=1) and region as covariates.|A hazard ratio less than 1 indicates that Symbicort 'as needed' prolongs the time to first moderate or severe exacerbation.|||1.153|0.718|0.436
72539074|NCT02149199|144607786|SUPERIORITY||Mean Difference (Net)|53.8|||<|0.001|TWO_SIDED|95.0|29.1|78.5|||Mixed Models Analysis|MMRM with treatment, pre-study treatment, region, visit and (treatment x visit) as fixed, patient as random and baseline FEV1 as continuous covariate.|Mean difference greater than 0 favours Symbicort 'as needed'. This is the estimate across all treatment visits.|||78.5|29.1|<0.001
72539075|NCT02149199|144607786|SUPERIORITY||Mean Difference (Net)|-54.3|||<|0.001|TWO_SIDED|95.0|-78.8|-29.8|||Mixed Models Analysis|MMRM with treatment, pre-study treatment, region, visit and (treatment x visit) as fixed, patient as random and baseline FEV1 as continuous covariate.|Mean difference greater than 0 favours Symbicort 'as needed'. This is the estimate across all treatment visits.|||-29.8|-78.8|<0.001
72539076|NCT02149199|144607787|SUPERIORITY||Mean Difference (Net)|11.95|||<|0.001|TWO_SIDED|95.0|7.89|16.0|||ANCOVA|ANCOVA model with randomised treatment, pre-study treatment and region as factors and baseline PEF as a continuous covariate.|Mean difference greater than 0 favours Symbicort 'as needed'.|||16.00|7.89|<0.001
72539077|NCT02149199|144607787|SUPERIORITY||Mean Difference (Net)|-9.98|||<|0.001|TWO_SIDED|95.0|-14.03|-5.93|||ANCOVA|ANCOVA model with randomised treatment, pre-study treatment and region as factors and baseline PEF as a continuous covariate.|Mean difference greater than 0 favours Symbicort 'as needed'.|||-5.93|-14.03|<0.001
72539078|NCT02149199|144607788|SUPERIORITY||Mean Difference (Net)|10.94|||<|0.001|TWO_SIDED|95.0|6.99|14.9|||ANCOVA|ANCOVA model with randomised treatment, pre-study treatment and region as factors and baseline PEF as a continuous covariate.|Mean difference greater than 0 favours Symbicort 'as needed'.|||14.90|6.99|<0.001
72539079|NCT02149199|144607788|SUPERIORITY||Mean Difference (Net)|-6.23||||0.002|TWO_SIDED|95.0|-10.18|-2.29|||ANCOVA|ANCOVA model with randomised treatment, pre-study treatment and region as factors and baseline PEF as a continuous covariate.|Mean difference greater than 0 favours Symbicort 'as needed'.|||-2.29|-10.18|0.002
72575268|NCT02792699|144676507|OTHER||LS Mean Difference|-3.096|||||TWO_SIDED|90.0|-9.883|3.691||||||Analysis of the LS mean difference (ABP 798/ABP 798 - Rituximab \[US\]/ABP 798) at week 48, based on an ANCOVA model adjusted for the stratification variables geographic region, seropositivity, and number of prior biologic therapies used for RA.||3.691|-9.883|
72575269|NCT02792699|144676508|OTHER||Risk Difference (RD)|-0.0245|||||TWO_SIDED|90.0|-0.1083|0.0593|||||Based on a generalized linear model adjusted for geographic region, seropositivity and prior biologic use as covariates in the model.|||0.0593|-0.1083|
72575270|NCT02792699|144676508|OTHER||Risk Difference (RD)|0.0187|||||TWO_SIDED|90.0|-0.061|0.0984|||||Based on a generalized linear model adjusted for geographic region, seropositivity and prior biologic use as covariates in the model.|||0.0984|-0.0610|
72575271|NCT03464630|144676513|SUPERIORITY|||||||0.503||||||P-value is Bonferroni correction adjusted at 0.05|GLM Repeated Measures|||||||0.503
72539080|NCT02149199|144607790|SUPERIORITY||Mean Difference (Net)|-0.12|||<|0.001|TWO_SIDED|95.0|-0.18|-0.06|||ANCOVA|ANCOVA model with randomised treatment, pre-study treatment and region as factors and baseline asthma symptom score as a continuous covariate.|Mean difference less than 0 favours Symbicort 'as needed'.|||-0.06|-0.18|<0.001
72539081|NCT02149199|144607790|SUPERIORITY||Mean Difference (Net)|0.09||||0.004|TWO_SIDED|95.0|0.03|0.15|||ANCOVA|ANCOVA model with randomised treatment, pre-study treatment and region as factors and baseline asthma symptom score as a continuous covariate.|Mean difference less than 0 favours Symbicort 'as needed'.|||0.15|0.03|0.004
72539082|NCT02149199|144607797|SUPERIORITY||Hazard Ratio (HR)|0.413|||<|0.001|TWO_SIDED|95.0|0.343|0.497|||Regression, Cox|Cox regression model with randomised treatment, pre-study treatment and region as covariates.|A hazard ratio less than 1 indicates that Symbicort 'as needed' prolongs the time to first additional steroids.|||0.497|0.343|<0.001
72575272|NCT03464630|144676514|SUPERIORITY||||||<|0.001||||||P-value is Bonferroni correction adjusted at 0.05|GLM Repeated Measures|||||||<0.001
72575273|NCT03464630|144676515|SUPERIORITY|||||||0.059||||||P-value is Bonferroni correction adjusted at 0.05|GLM Repeated Measures|||||||0.059
72575274|NCT03464630|144676516|SUPERIORITY|||||||0.702||||||P-value is Bonferroni correction adjusted at 0.05|GLM Repeated Measures|||||||0.702
72575275|NCT03464630|144676517|SUPERIORITY|||||||0.08||||||P-value is Bonferroni correction adjusted at 0.05|GLM Repeated Measures|||||||0.08
72539083|NCT02149199|144607797|SUPERIORITY||Hazard Ratio (HR)|0.865||||0.175|TWO_SIDED|95.0|0.701|1.067|||Regression, Cox|Cox regression model with randomised treatment, pre-study treatment and region as covariates.|A hazard ratio less than 1 indicates that Symbicort 'as needed' prolongs the time to first additional steroids.|||1.067|0.701|0.175
72575276|NCT03464630|144676518|SUPERIORITY|||||||0.09||||||P-value is Bonferroni correction adjusted at 0.05|GLM Repeated Measures|||||||0.09
72575277|NCT03464630|144676519|SUPERIORITY|||||||0.898||||||P-value is Bonferroni correction adjusted at 0.05|GLM Repeated Measures|||||||0.898
72539084|NCT02149199|144607798|SUPERIORITY||Mean Difference (Net)|-0.154|||<|0.001|TWO_SIDED|95.0|-0.203|-0.105|||Mixed Models Analysis|MMRM with treatment, pre-study treatment, region, visit and (treatment x visit) as fixed, patient as random and baseline ACQ-5 as continuous covariate|Mean difference less than 0 favours Symbicort 'as needed'.|||-0.105|-0.203|<0.001
72539085|NCT02149199|144607798|SUPERIORITY||Mean Difference (Net)|0.149|||<|0.001|TWO_SIDED|95.0|0.101|0.198|||Mixed Models Analysis|MMRM with treatment, pre-study treatment, region, visit and (treatment x visit) as fixed, patient as random and baseline ACQ-5 as continuous covariate|Mean difference less than 0 favours Symbicort 'as needed'.|||0.198|0.101|<0.001
72539086|NCT02149199|144607799|SUPERIORITY||Mean Difference (Net)|0.127|||<|0.001|TWO_SIDED|95.0|0.074|0.181|||Mixed Models Analysis|MMRM with treatment, pre-study treatment, region, visit and treatment x visit as fixed, patient as random and baseline AQLQ(S) as continuous covariate|Mean difference greater than 0 favours Symbicort 'as needed'.|||0.181|0.074|<0.001
72539087|NCT02149199|144607799|SUPERIORITY||Mean Difference (Net)|-0.102|||<|0.001|TWO_SIDED|95.0|-0.155|-0.049|||Mixed Models Analysis|MMRM with treatment, pre-study treatment, region, visit and treatment x visit as fixed, patient as random and baseline AQLQ(S) as continuous covariate|Mean difference greater than 0 favours Symbicort 'as needed'.|||-0.049|-0.155|<0.001
72539088|NCT02149199|144607801|SUPERIORITY||Rate ratio|0.36|||<|0.001|TWO_SIDED|95.0|0.27|0.49|||Negative binomial model|Negative binomial model with treatment, pre-study treatment, severe exacerbations in the last 12 months (0,\>=1) and region as covariates|A rate ratio less than 1 indicates a lower rate of severe exacerbations in the Symbicort 'as needed' treatment group.|||0.49|0.27|<0.001
72539089|NCT02149199|144607801|SUPERIORITY||Rate ratio|0.83||||0.279|TWO_SIDED|95.0|0.59|1.16|||Negative binomial model|Negative binomial model with treatment, pre-study treatment, severe exacerbations in the last 12 months (0,\>=1) and region as covariates|A rate ratio less than 1 indicates a lower rate of severe exacerbations in the Symbicort 'as needed' treatment group.|||1.16|0.59|0.279
72539090|NCT02149199|144607802|SUPERIORITY||Rate ratio|0.4|||<|0.001|TWO_SIDED|95.0|0.32|0.49|||Negative binomial model|Negative binomial model with treatment, pre-study treatment, severe exacerbations in the last 12 months (0,\>=1) and region as covariates|A rate ratio less than 1 indicates a lower rate of moderate or severe exacerbations in the Symbicort 'as needed' treatment group.|||0.49|0.32|<0.001
72539091|NCT02149199|144607802|SUPERIORITY||Rate ratio|0.95||||0.663|TWO_SIDED|95.0|0.74|1.21|||Negative binomial model|Negative binomial model with treatment, pre-study treatment, severe exacerbations in the last 12 months (0,\>=1) and region as covariates|A rate ratio less than 1 indicates a lower rate of moderate or severe exacerbations in the Symbicort 'as needed' treatment group.|||1.21|0.74|0.663
72539092|NCT01500434|144607856|NON_INFERIORITY_OR_EQUIVALENCE|Study had 85% statistical power to demonstrate that the 12-month rate for TLF (accounting for an expected 1-year attrition rate of 5%) is less than the performance goal, assuming a 1-year TLF rate of 9.0%.|Target Lesion Failure Rate|3.2|||<|0.0001|ONE_SIDED|95.0||7.96|||One-group exact binomial test|||A one-group exact binomial test was used to test the hypothesis that the primary endpoint rate in the PROMUS Element cohort is less than the predefined performance goal of 19.4%.||7.96||<0.0001
72539093|NCT01966107|144607885|SUPERIORITY||Rate ratio|0.65||||0.006|TWO_SIDED|95.0|0.48|0.89|||Negative Binomial Regression model||||A rate ratio \<1 represents a favorable outcome for aclidinium bromide 400 μg.|0.89|0.48|0.006
72539094|NCT01966107|144607887|NON_INFERIORITY|Estimate of the hazard ratio and its 95% CI for comparing aclidinium bromide 400 μg versus placebo were derived using the Cox proportional hazard model. A hazard ratio \<1 represents a favorable outcome for aclidinium bromide 400 μg.|Hazard Ratio (HR)|0.89|||||TWO_SIDED|95.0|0.64|1.23||||||Composite MACE||1.23|0.64|
72539095|NCT00532779|144607888|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.67|||<|0.001||95.0|-4.5|-2.85|||ANCOVA|||||-2.85|-4.50|<0.001
72575278|NCT03464630|144676520|SUPERIORITY|||||||0.349||||||P-value is Bonferroni correction adjusted at 0.05|GLM Repeated Measures|||||||0.349
72575279|NCT03464630|144676521|SUPERIORITY||||||<|0.001||||||P-value is Bonferroni correction adjusted at 0.05|GLM Repeated Measures|||||||<0.001
72539096|NCT00532779|144607888|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.81|||<|0.001|TWO_SIDED|95.0|-5.63|-3.99|||ANCOVA|||||-3.99|-5.63|<0.001
72539097|NCT00532779|144607889|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.42|||<|0.001||95.0|2.52|4.63|||Regression, Logistic|||||4.63|2.52|<0.001
72539098|NCT00532779|144607889|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.86|||<|0.001||95.0|3.6|6.57|||Regression, Logistic|||||6.57|3.60|<0.001
72539099|NCT00532779|144607890|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.21|||<|0.001|TWO_SIDED|95.0|2.14|4.81|||Regression, Logistic|||||4.81|2.14|<0.001
72539100|NCT00532779|144607890|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.19|||<|0.001|TWO_SIDED|95.0|2.82|6.23|||Regression, Logistic|||||6.23|2.82|<0.001
72539101|NCT00532779|144607891|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.58|||<|0.001|TWO_SIDED|95.0|-3.74|-1.43|||ANCOVA|||||-1.43|-3.74|<0.001
72539102|NCT00532779|144607891|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.78|||<|0.001|TWO_SIDED|95.0|-4.93|-2.64|||ANCOVA|||||-2.64|-4.93|<0.001
72539103|NCT00532779|144607892|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.42|||<|0.001|TWO_SIDED|95.0|2.17|4.66|||ANCOVA|||||4.66|2.17|<0.001
72539104|NCT00532779|144607892|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.48|||<|0.001|TWO_SIDED|95.0|2.26|4.7|||ANCOVA|||||4.70|2.26|<0.001
72575280|NCT01338870|144676544|SUPERIORITY_OR_OTHER||Least squares (LS) mean difference|0.1|STANDARD_ERROR_OF_MEAN|0.145||0.7606|TWO_SIDED|80.0|-0.08|0.29|||Mixed Models Analysis|||Treatment difference and 80% confidence interval (CI) were based on least squares (LS) mean. A mixed model repeated measure (MMRM) analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction, baseline-by-treatment interaction, baseline-by-treatment-by-time interaction as the covariates, time was repeated for participant.||0.29|-0.08|0.7606
72539105|NCT00532779|144607893|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.88|||=|0.046|TWO_SIDED||||||ANCOVA|||||||=0.046
72539106|NCT00532779|144607893|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-9.61|||<|0.001|TWO_SIDED||||||ANCOVA|||||||<0.001
72575281|NCT01338870|144676544|SUPERIORITY_OR_OTHER||LS mean difference|-0.28|STANDARD_ERROR_OF_MEAN|0.142||0.0266|TWO_SIDED|80.0|-0.46|-0.09|||Mixed Models Analysis|||Treatment difference and 80% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction, baseline-by-treatment interaction, baseline-by-treatment-by-time interaction as the covariates, time was repeated for participant.||-0.09|-0.46|0.0266
72575282|NCT01338870|144676544|SUPERIORITY_OR_OTHER||LS mean difference|-0.24|STANDARD_ERROR_OF_MEAN|0.141||0.044|TWO_SIDED|80.0|-0.42|-0.06|||Mixed Models Analysis|||Treatment difference and 80% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction, baseline-by-treatment interaction, baseline-by-treatment-by-time interaction as the covariates, time was repeated for participant.||-0.06|-0.42|0.0440
72575283|NCT01338870|144676544|SUPERIORITY_OR_OTHER||LS mean difference|-0.53|STANDARD_ERROR_OF_MEAN|0.137||0.0001|TWO_SIDED|80.0|-0.71|-0.36|||Mixed Models Analysis|||Treatment difference and 80% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction, baseline-by-treatment interaction, baseline-by-treatment-by-time interaction as the covariates, time was repeated for participant.||-0.36|-0.71|0.0001
72575284|NCT01338870|144676544|SUPERIORITY_OR_OTHER||LS mean difference|-0.43|STANDARD_ERROR_OF_MEAN|0.139||0.0013|TWO_SIDED|80.0|-0.6|-0.25|||Mixed Models Analysis|||Treatment difference and 80% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction, baseline-by-treatment interaction, baseline-by-treatment-by-time interaction as the covariates, time was repeated for participant.||-0.25|-0.60|0.0013
72539107|NCT00532779|144607894|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.13|||<|0.001|TWO_SIDED|95.0|1.72|4.54|||ANCOVA|||||4.54|1.72|<0.001
72539108|NCT00532779|144607894|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.14|||<|0.001|TWO_SIDED|95.0|2.73|5.56|||ANCOVA|||||5.56|2.73|<0.001
72539109|NCT00532779|144607895|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-11.36|||=|0.016|TWO_SIDED||||||ANCOVA|||||||=0.016
72539110|NCT00532779|144607895|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-12.32|||=|0.008|TWO_SIDED||||||ANCOVA|||||||=0.008
72539111|NCT00532779|144607896|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-7.27|||=|0.063|TWO_SIDED||||||ANCOVA|||||||=0.063
72539112|NCT00532779|144607896|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-12.57|||<|0.001|TWO_SIDED||||||ANCOVA|||||||<0.001
72539113|NCT00532779|144607897|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.09|||||TWO_SIDED|95.0|-2.6|0.42||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||0.42|-2.60|
72409681|NCT00807092|144327728|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.012|STANDARD_ERROR_OF_MEAN|0.038||0.7544||95.0|-0.088|0.064||A statistical significant threshold p\<0.05|ANCOVA|Treatment and strata as factors; baseline (week 0) value of duration of hypoglycaemic events as covariate|Blood glucose below 2.5 mmol/l|"The null hypothesis (H0) was:~H0: Duration of Hypoglycaemic Events Based on CGMS of BIAsp 30 after 6 weeks of treatment-Duration of Hypoglycaemic Events Based on CGMS of BHI 30 after 6 weeks of treatment =0 hours against the alternative hypothesis(H1): H1: Duration of Hypoglycaemic Events Based on CGMS of BIAsp 30 after 6 weeks of treatment-Duration of Hypoglycaemic Events Based on CGMS of BHI 30 after 6 weeks of treatment≠0 hours"||0.064|-0.088|0.7544
72409682|NCT04116229|144327730|EQUIVALENCE|"Alternative hypothesis: people with normal-weight BMI have lower DBSI restricted fraction, or putative cellularity, than people with obesity.~Null hypothesis: DBSI restricted fraction, or putative cellularity, is not different between normal-weight and obese groups."|Median Difference (Final Values)|0.05||||0.28|TWO_SIDED|||||a priori threshold: p \< 0.05|Independent-Samples Median Test|||This is a pilot study with a small sample. Power to detect significant results is therefore low in the current study.||||0.28
72409683|NCT04116229|144327730|EQUIVALENCE|"Alternative hypothesis: people with normal-weight BMI have lower DBSI hindered fraction, or putative vasogenic edema, than people with obesity.~Null hypothesis: DBSI hindered fraction, or putative vasogenic edema, is not different between normal-weight and obese groups."|Median Difference (Final Values)|0.18||||0.03|TWO_SIDED|||||a priori threshold: p \< 0.05|Independent-Samples Median Test|||This is a pilot study with a small sample. Power to detect significant results is therefore low in the current study.||||0.03
72409684|NCT04116229|144327731|OTHER|"Alternative hypothesis: Worse crystallized cognitive function will relate to greater putative vasogenic edema (DBSI HF) in white matter tracts.~Null hypothesis: Crystallized cogntive function is not related to DBSI HF."|Slope|-0.69||||0.01|TWO_SIDED|||||a priori threshold: p \< 0.05|Regression, Linear|||This is a pilot study with a small sample. Power to detect significant results is therefore low in the current study. Analyses performed across normal-weight and obese groups.||||0.01
72539114|NCT00532779|144607897|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.94|||=|0.01|TWO_SIDED|95.0|-3.42|-0.46|||ANCOVA|||||-0.46|-3.42|=0.010
72539115|NCT00532779|144607898|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-8.43|||||TWO_SIDED|||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||
72539116|NCT00532779|144607898|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-14.29|||<|0.001|TWO_SIDED||||||ANCOVA|||||||<0.001
72539117|NCT00532779|144607899|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.81|||||TWO_SIDED|95.0|-6.68|-0.94||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||-0.94|-6.68|
72539118|NCT00532779|144607899|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.84|||<|0.001|TWO_SIDED|95.0|-8.71|-2.98|||ANCOVA|||||-2.98|-8.71|<0.001
72409685|NCT04116229|144327731|OTHER|"Alternative hypothesis: Worse fluid cognitive function will relate to greater putative vasogenic edema (DBSI HF) in white matter tracts.~Null hypothesis: Fluid cogntive function is not related to DBSI HF."|Slope|0.52||||0.1|TWO_SIDED|||||a priori threshold: p \< 0.05|Regression, Linear|||This is a pilot study with a small sample. Power to detect significant results is therefore low in the current study. Analyses performed across normal-weight and obese groups.||||0.10
72409686|NCT04116229|144327731|OTHER|"Alternative hypothesis: Worse crystallized cognitive function will relate to greater putative cellularity (DBSI RF) in white matter tracts.~Null hypothesis: Crystallized cognitive function is not related to DBSI RF."|Slope|-0.45||||0.01|TWO_SIDED|||||a priori threshold: p \< 0.05|Regression, Linear|||This is a pilot study with a small sample. Power to detect significant results is therefore low in the current study. Analyses performed across normal-weight and obese groups.||||0.01
72409687|NCT04116229|144327731|OTHER|"Alternative hypothesis: Worse fluid cognitive function will relate to greater putative cellularity (DBSI RF) in white matter tracts.~Null hypothesis: Fluid cognitive function is not related to DBSI RF."|Slope|0.22||||0.1|TWO_SIDED|||||a priori threshold: p \< 0.05|Regression, Linear|||This is a pilot study with a small sample. Power to detect significant results is therefore low in the current study. Analyses performed across normal-weight and obese groups.||||0.10
72539119|NCT00532779|144607900|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.39|||||TWO_SIDED|95.0|-3.62|2.84||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||2.84|-3.62|
72575285|NCT01338870|144676545|SUPERIORITY_OR_OTHER||LS mean difference|-5.21|STANDARD_ERROR_OF_MEAN|5.7||0.3611|TWO_SIDED|95.0|-16.4|5.98|||Mixed Models Analysis|||Week 1: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||5.98|-16.40|0.3611
72539120|NCT00532779|144607900|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.13||||0.484|TWO_SIDED|95.0|-4.29|2.04|||ANCOVA|||||2.04|-4.29|0.484
72539121|NCT00532779|144607901|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.23|||||TWO_SIDED|95.0|1.16|3.3||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||3.30|1.16|
72539122|NCT00532779|144607901|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.83|||||TWO_SIDED|95.0|0.76|2.9||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||2.90|0.76|
72539123|NCT00532779|144607902|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.96|||||TWO_SIDED|95.0|0.19|1.73||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||1.73|0.19|
72539124|NCT00532779|144607902|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.9|||||TWO_SIDED|95.0|0.13|1.67||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||1.67|0.13|
72539125|NCT00532779|144607903|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.74|||||TWO_SIDED|95.0|0.19|1.28||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||1.28|0.19|
72539126|NCT00532779|144607903|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.46|||||TWO_SIDED|95.0|-0.09|1.0||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||1.00|-0.09|
72539127|NCT00532779|144607904|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.69|||||TWO_SIDED|95.0|0.14|1.23||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||1.23|0.14|
72539128|NCT00532779|144607904|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.15|||||TWO_SIDED|95.0|-0.4|0.69||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||0.69|-0.40|
72539129|NCT00532779|144607905|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0|||||TWO_SIDED|95.0|-0.53|0.53||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||0.53|-0.53|
72539130|NCT00532779|144607905|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.27|||||TWO_SIDED|95.0|-0.8|0.27||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||0.27|-0.80|
72539131|NCT00689273|144607910|SUPERIORITY||Least Square (LS) Mean Difference|-0.49|STANDARD_ERROR_OF_MEAN|0.57||0.39|TWO_SIDED|80.0|-1.23|0.24|||Mixed Models Analysis|||Results were obtained from a mixed effect repeated measure model using unstructured covariance matrix. The model included random-effect terms for participant, and fixed-effect terms for baseline response, treatment group, time, treatment-by-time interaction, and country effect. One-sided alpha of 0.1 was used for the analysis.||0.24|-1.23|0.39
72539132|NCT00689273|144607911|SUPERIORITY||LS Mean Difference|-0.25|STANDARD_ERROR_OF_MEAN|0.52||0.63|TWO_SIDED|80.0|-0.92|0.42|||Mixed Models Analysis|||Results were obtained from a mixed effect repeated measure model using unstructured covariance matrix. The model included random-effect terms for participant, and fixed-effect terms for baseline response, treatment group, time, treatment-by-time interaction, and country effect.||0.42|-0.92|0.63
72539133|NCT00689273|144607912|SUPERIORITY||LS Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.27||0.54|TWO_SIDED|80.0|-0.51|0.18|||Mixed Models Analysis|||Week 1: Results were obtained from a mixed effect repeated measure model using unstructured covariance matrix. The model included random-effect terms for participant, and fixed-effect terms for baseline response, treatment group, time, treatment-by-time interaction, and country effect.||0.18|-0.51|0.54
72539134|NCT00689273|144607912|SUPERIORITY||LS Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.28||0.6|TWO_SIDED|80.0|-0.51|0.21|||Mixed Models Analysis|||Week 2: Results were obtained from a mixed effect repeated measure model using unstructured covariance matrix. The model included random-effect terms for participant, and fixed-effect terms for baseline response, treatment group, time, treatment-by-time interaction, and country effect.||0.21|-0.51|0.60
72575286|NCT01338870|144676545|SUPERIORITY_OR_OTHER||LS mean difference|-9.45|STANDARD_ERROR_OF_MEAN|5.686||0.0969|TWO_SIDED|95.0|-20.61|1.71|||Mixed Models Analysis|||Week 1: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||1.71|-20.61|0.0969
72575287|NCT01338870|144676545|SUPERIORITY_OR_OTHER||LS mean difference|-8.1|STANDARD_ERROR_OF_MEAN|5.71||0.1566|TWO_SIDED|95.0|-19.3|3.11|||Mixed Models Analysis|||Week 1: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||3.11|-19.30|0.1566
72539135|NCT00689273|144607913|SUPERIORITY||LS Mean Difference|-1.38|STANDARD_ERROR_OF_MEAN|1.8||0.44|TWO_SIDED|80.0|-3.69|0.94|||Mixed Models Analysis|||Week 1: Results were obtained from a mixed effect repeated measure model using unstructured covariance matrix. The model included random-effect terms for participant, and fixed-effect terms for baseline response, treatment group, time, treatment-by-time interaction, and country effect.||0.94|-3.69|0.44
72539136|NCT00689273|144607913|SUPERIORITY||LS Mean Difference|-2.42|STANDARD_ERROR_OF_MEAN|2.0||0.23|TWO_SIDED|80.0|-5.0|0.16|||Mixed Models Analysis|||Week 2: Results were obtained from a mixed effect repeated measure model using unstructured covariance matrix. The model included random-effect terms for participant, and fixed-effect terms for baseline response, treatment group, time, treatment-by-time interaction, and country effect.||0.16|-5.00|0.23
72539137|NCT00689273|144607914|SUPERIORITY||LS Mean Difference|-1.76|STANDARD_ERROR_OF_MEAN|2.46||0.48|TWO_SIDED|80.0|-4.94|1.41|||Mixed Models Analysis|||Week 1: Results were obtained from a mixed effect repeated measure model using unstructured covariance matrix. The model included random-effect terms for participant, and fixed-effect terms for baseline response, treatment group, time, treatment-by-time interaction, and country effect.||1.41|-4.94|0.48
72539138|NCT00689273|144607914|SUPERIORITY||LS Mean Difference|-3.02|STANDARD_ERROR_OF_MEAN|2.79||0.28|TWO_SIDED|80.0|-6.61|0.57|||Mixed Models Analysis|||Week 2: Results were obtained from a mixed effect repeated measure model using unstructured covariance matrix. The model included random-effect terms for participant, and fixed-effect terms for baseline response, treatment group, time, treatment-by-time interaction, and country effect.||0.57|-6.61|0.28
72539139|NCT00689273|144607915|SUPERIORITY||LS Mean Difference|-0.65|STANDARD_ERROR_OF_MEAN|0.91||0.48|TWO_SIDED|80.0|-1.81|0.52|||Mixed Models Analysis|||Week 1: Results were obtained from a mixed effect repeated measure model using unstructured covariance matrix. The model included random-effect terms for participant, and fixed-effect terms for baseline response, treatment group, time, treatment-by-time interaction, and country effect.||0.52|-1.81|0.48
72539140|NCT00689273|144607915|SUPERIORITY||LS Mean Difference|-1.12|STANDARD_ERROR_OF_MEAN|1.03||0.28|TWO_SIDED|80.0|-2.45|0.2|||Mixed Models Analysis|||Week 2: Results were obtained from a mixed effect repeated measure model using unstructured covariance matrix. The model included random-effect terms for participant, and fixed-effect terms for baseline response, treatment group, time, treatment-by-time interaction, and country effect.||0.20|-2.45|0.28
72539141|NCT00689273|144607916|SUPERIORITY||LS Mean Difference|-0.21|STANDARD_ERROR_OF_MEAN|0.19||0.28|TWO_SIDED|80.0|-0.46|0.04|||Mixed Models Analysis|||Week 1: Results were obtained from a mixed effect repeated measure model using unstructured covariance matrix. The model included random-effect terms for participant, and fixed-effect terms for baseline response, treatment group, time, treatment-by-time interaction, and country effect.||0.04|-0.46|0.28
72539142|NCT00689273|144607916|SUPERIORITY||LS Mean Difference|-0.42|STANDARD_ERROR_OF_MEAN|0.28||0.14|TWO_SIDED|80.0|-0.78|-0.06|||Mixed Models Analysis|||Week 2: Results were obtained from a mixed effect repeated measure model using unstructured covariance matrix. The model included random-effect terms for participant, and fixed-effect terms for baseline response, treatment group, time, treatment-by-time interaction, and country effect.||-0.06|-0.78|0.14
72539143|NCT00689273|144607917|SUPERIORITY||LS Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.28||0.55|TWO_SIDED|80.0|-0.52|0.19|||Mixed Models Analysis|||Day 1: Results were obtained from a mixed effect repeated measure model using compound symmetry covariance matrix. The model included random-effect terms for participant, and fixed-effect terms for baseline response, treatment group, time, treatment-by-time interaction, and country effect.||0.19|-0.52|0.55
72539144|NCT00689273|144607917|SUPERIORITY||LS Mean Difference|-0.45|STANDARD_ERROR_OF_MEAN|0.28||0.11|TWO_SIDED|80.0|-0.81|-0.09|||Mixed Models Analysis|||Day 2: Results were obtained from a mixed effect repeated measure model using compound symmetry covariance matrix. The model included random-effect terms for participant, and fixed-effect terms for baseline response, treatment group, time, treatment-by-time interaction, and country effect.||-0.09|-0.81|0.11
72539145|NCT00689273|144607917|SUPERIORITY||LS Mean Difference|-0.35|STANDARD_ERROR_OF_MEAN|0.28||0.2|TWO_SIDED|80.0|-0.71|0.0|||Mixed Models Analysis|||Day 3: Results were obtained from a mixed effect repeated measure model using compound symmetry covariance matrix. The model included random-effect terms for participant, and fixed-effect terms for baseline response, treatment group, time, treatment-by-time interaction, and country effect.||0.00|-0.71|0.20
72539146|NCT00689273|144607917|SUPERIORITY||LS Mean Difference|-0.33|STANDARD_ERROR_OF_MEAN|0.28||0.23|TWO_SIDED|80.0|-0.69|0.02|||Mixed Models Analysis|||Day 4: Results were obtained from a mixed effect repeated measure model using compound symmetry covariance matrix. The model included random-effect terms for participant, and fixed-effect terms for baseline response, treatment group, time, treatment-by-time interaction, and country effect.||0.02|-0.69|0.23
72539147|NCT00689273|144607917|SUPERIORITY||LS Mean Difference|-0.23|STANDARD_DEVIATION|0.28||0.41|TWO_SIDED|80.0|-0.58|0.13|||Mixed Models Analysis|||Day 5: Results were obtained from a mixed effect repeated measure model using compound symmetry covariance matrix. The model included random-effect terms for participant, and fixed-effect terms for baseline response, treatment group, time, treatment-by-time interaction, and country effect.||0.13|-0.58|0.41
72539148|NCT00689273|144607917|SUPERIORITY||LS Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.28||0.62|TWO_SIDED|80.0|-0.49|0.22|||Mixed Models Analysis|||Day 6: Results were obtained from a mixed effect repeated measure model using compound symmetry covariance matrix. The model included random-effect terms for participant, and fixed-effect terms for baseline response, treatment group, time, treatment-by-time interaction, and country effect.||0.22|-0.49|0.62
72539149|NCT00689273|144607917|SUPERIORITY||LS Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.28||0.49|TWO_SIDED|80.0|-0.55|0.16|||Mixed Models Analysis|||Day 7: Results were obtained from a mixed effect repeated measure model using compound symmetry covariance matrix. The model included random-effect terms for participant, and fixed-effect terms for baseline response, treatment group, time, treatment-by-time interaction, and country effect.||0.16|-0.55|0.49
72539150|NCT00689273|144607917|SUPERIORITY||LS Mean Difference|-0.46|STANDARD_DEVIATION|0.28||0.1|TWO_SIDED|80.0|-0.81|-0.1|||Mixed Models Analysis|||Day 8: Results were obtained from a mixed effect repeated measure model using compound symmetry covariance matrix. The model included random-effect terms for participant, and fixed-effect terms for baseline response, treatment group, time, treatment-by-time interaction, and country effect.||-0.10|-0.81|0.10
72539151|NCT00689273|144607917|SUPERIORITY||LS Mean Difference|-0.33|STANDARD_ERROR_OF_MEAN|0.28||0.24|TWO_SIDED|80.0|-0.69|0.03|||Mixed Models Analysis|||Day 9: Results were obtained from a mixed effect repeated measure model using compound symmetry covariance matrix. The model included random-effect terms for participant, and fixed-effect terms for baseline response, treatment group, time, treatment-by-time interaction, and country effect.||0.03|-0.69|0.24
72539152|NCT00689273|144607917|SUPERIORITY||LS Mean Difference|-0.65|STANDARD_ERROR_OF_MEAN|0.28||0.02|TWO_SIDED|80.0|-1.01|-0.28|||Mixed Models Analysis|||Day 10: Results were obtained from a mixed effect repeated measure model using compound symmetry covariance matrix. The model included random-effect terms for participant, and fixed-effect terms for baseline response, treatment group, time, treatment-by-time interaction, and country effect.||-0.28|-1.01|0.02
72539153|NCT00689273|144607917|SUPERIORITY||LS Mean Difference|-0.57|STANDARD_ERROR_OF_MEAN|0.28||0.04|TWO_SIDED|80.0|-0.93|-0.21|||Mixed Models Analysis|||Day 11: Results were obtained from a mixed effect repeated measure model using compound symmetry covariance matrix. The model included random-effect terms for participant, and fixed-effect terms for baseline response, treatment group, time, treatment-by-time interaction, and country effect.||-0.21|-0.93|0.04
72539154|NCT00689273|144607917|SUPERIORITY||LS Mean Difference|-0.59|STANDARD_ERROR_OF_MEAN|0.28||0.04|TWO_SIDED|80.0|-0.95|-0.23|||Mixed Models Analysis|||Day 12: Results were obtained from a mixed effect repeated measure model using compound symmetry covariance matrix. The model included random-effect terms for participant, and fixed-effect terms for baseline response, treatment group, time, treatment-by-time interaction, and country effect.||-0.23|-0.95|0.04
72539155|NCT00689273|144607917|SUPERIORITY||LS Mean Difference|-0.33|STANDARD_ERROR_OF_MEAN|0.28||0.24|TWO_SIDED|80.0|-0.7|0.03|||Mixed Models Analysis|||Day 13: Results were obtained from a mixed effect repeated measure model using compound symmetry covariance matrix. The model included random-effect terms for participant, and fixed-effect terms for baseline response, treatment group, time, treatment-by-time interaction, and country effect.||0.03|-0.70|0.24
72539156|NCT00689273|144607917|SUPERIORITY||Slope|-0.45|STANDARD_ERROR_OF_MEAN|0.28||0.11|TWO_SIDED|80.0|-0.82|-0.09|||Mixed Models Analysis|||Day 14: Results were obtained from a mixed effect repeated measure model using compound symmetry covariance matrix. The model included random-effect terms for participant, and fixed-effect terms for baseline response, treatment group, time, treatment-by-time interaction, and country effect.||-0.09|-0.82|0.11
72539157|NCT00689273|144607918|SUPERIORITY|||||||0.22|||||||Cochran-Mantel-Haenszel|||30% Reduction||||0.22
72539158|NCT00689273|144607918|SUPERIORITY|||||||0.38|||||||Cochran-Mantel-Haenszel|||50% Reduction||||0.38
72539159|NCT00689273|144607919|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.13||0.45|TWO_SIDED|80.0|-0.27|0.07|||Mixed Models Analysis|||Week 1: Results were obtained from a mixed effect repeated measure model using unstructured covariance matrix. The model included random-effect terms for participant, and fixed-effect terms for baseline response, treatment group, time, treatment-by-time interaction, and country effect.||0.07|-0.27|0.45
72409688|NCT04116229|144327732|OTHER|"Alternative hypothesis: higher levels of insulin, a pro-inflammatory marker, will relate to higher levels of putative neuroinflammation in white matter tracts as measured by DBSI restricted fraction after controlling for BMI.~Null hypothesis: Insulin levels will not be related to DBSI RF in white matter tracts after controlling for BMI."|Slope|-0.18|||>|0.46|TWO_SIDED|||||a priori threshold: p \< 0.05|Regression, Linear|||"This is a pilot study with a small sample. Power to detect significant results is therefore low in the current study.~Analyses performed across normal-weight and obese groups."||||>0.46
72539160|NCT00689273|144607919|SUPERIORITY||LS Mean Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.13||0.37|TWO_SIDED|80.0|-0.29|0.05|||Mixed Models Analysis|||Week 2: Results were obtained from a mixed effect repeated measure model using unstructured covariance matrix. The model included random-effect terms for participant, and fixed-effect terms for baseline response, treatment group, time, treatment-by-time interaction, and country effect.||0.05|-0.29|0.37
72539161|NCT01556165|144607931|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.0|STANDARD_ERROR_OF_MEAN|1.32||0.0254|TWO_SIDED|75.0|-4.53|-1.47||No adjustments for multiple comparisons were made.|ANCOVA|||This study was designed to show a trend, that is, to show a clinical difference in the primary efficacy analysis, at a two-sided significance level of 0.25. Assuming a difference between rasagiline and placebo of a 3-point change in the UPDRS total score and a standard deviation on the change from baseline of 7 points, a sample size of 60 patients per treatment group gave an 88% probability of showing a trend. LOCF (last observation carried forward) was used.||-1.47|-4.53|0.0254
72539162|NCT01556165|144607932|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.62|STANDARD_ERROR_OF_MEAN|0.21||0.0032|TWO_SIDED|95.0|-1.03|-0.21|||ANCOVA|The same ANCOVA methodology as for the primary endpoint was used.||LOCF (last observation carried forward) was used.||-0.21|-1.03|0.0032
72539163|NCT01556165|144607933|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.67|STANDARD_ERROR_OF_MEAN|0.52||0.1963|TWO_SIDED|95.0|-1.7|0.35|||ANCOVA|The same ANCOVA methodology as for the primary endpoint was used.||LOCF (last observation carried forward) was used.||0.35|-1.70|0.1963
72539164|NCT01556165|144607934|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.71|STANDARD_ERROR_OF_MEAN|0.91||0.0641|TWO_SIDED|95.0|-3.52|0.1|||ANCOVA|The same ANCOVA methodology as for the primary endpoint was used.||LOCF (last observation carried forward) was used.||0.10|-3.52|0.0641
72539165|NCT01238172|144607937|SUPERIORITY||Hazard Ratio (HR)|0.96||||0.76|TWO_SIDED|95.0|0.75|1.24|||Log Rank|||||1.24|0.75|0.76
72539166|NCT01238172|144607938|SUPERIORITY||Hazard Ratio (HR)|1.41||||0.71|TWO_SIDED|95.0|0.23|8.41|||Log Rank|||||8.41|0.23|0.71
72539167|NCT01238172|144607939|SUPERIORITY|||||||0.995|||||||Wilcoxon (Mann-Whitney)|||||||0.995
72539168|NCT01238172|144607940|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|Two-sided||||||<0.001
72539169|NCT02787746|144608001|OTHER||Odds Ratio (OR)|0.988||||0.9744|TWO_SIDED|95.0|0.466|2.095|||Regression, Logistic|||Age (\>75y vs ≤75y）||2.095|0.466|0.9744
72539170|NCT02787746|144608001|OTHER||Odds Ratio (OR)|3.42||||0.3288|TWO_SIDED|95.0|0.29|40.354|||Regression, Logistic|||APOE ɛ4 (carrier vs non-carrier)||40.354|0.290|0.3288
72539171|NCT02787746|144608001|OTHER||Odds Ratio (OR)|2.107||||0.5732|TWO_SIDED|95.0|0.158|28.171|||Regression, Logistic|||Concomitant medication：Gastrointestinal drugs||28.171|0.158|0.5732
72539172|NCT02787746|144608001|OTHER||Odds Ratio (OR)|0.976||||0.9694|TWO_SIDED|95.0|0.281|3.387|||Regression, Logistic|||Concomitant medication：Hypoglycemic drugs||3.387|0.281|0.9694
72539173|NCT02787746|144608001|OTHER||Odds Ratio (OR)|2.221||||0.0396|TWO_SIDED|95.0|1.039|4.748|||Regression, Logistic|||Concomitant medication：Cardiovascular and Cerebrovascular drugs||4.748|1.039|0.0396
72539174|NCT02787746|144608001|OTHER||Odds Ratio (OR)|2.056||||0.5889|TWO_SIDED|95.0|0.151|28.074|||Regression, Logistic|||Concomitant medication：Hepatology drugs||28.074|0.151|0.5889
72539175|NCT02787746|144608001|OTHER||Odds Ratio (OR)|1.004||||0.1181|TWO_SIDED|95.0|0.999|1.008|||Regression, Logistic|||Duration of previous donepezil 5mg/d therapy (day)||1.008|0.999|0.1181
72539176|NCT02038959|144608016|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANCOVA|||||||>0.05
72539177|NCT02038959|144608021|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|||||||<0.0001
72539178|NCT02007369|144608080|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.21||||0.033|TWO_SIDED|95.0|0.05|0.89|||Regression, Logistic|||||0.89|0.05|0.033
72539179|NCT02007369|144608080|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.05||||0.934|TWO_SIDED|95.0|0.36|3.01|||Regression, Logistic|||||3.01|0.36|0.934
72539180|NCT02007369|144608081|SUPERIORITY_OR_OTHER|||||||0.002|||||||Fisher Exact|||||||0.002
72539181|NCT02007369|144608081|SUPERIORITY_OR_OTHER|||||||0.199|||||||Fisher Exact|||||||0.199
72539182|NCT02007369|144608082|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.61||||0.285|TWO_SIDED|95.0|0.25|1.5|||Regression, Logistic|||||1.50|0.25|0.285
72539183|NCT02007369|144608082|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.78||||0.597|TWO_SIDED|95.0|0.31|1.97|||Regression, Logistic|||||1.97|0.31|0.597
72539184|NCT02007369|144608083|SUPERIORITY_OR_OTHER|||||||0.023|||||||Fisher Exact|||||||0.023
72539185|NCT02007369|144608083|SUPERIORITY_OR_OTHER|||||||0.527|||||||Fisher Exact|||||||0.527
72539186|NCT02253654|144608101|SUPERIORITY_OR_OTHER||Treatment difference|0.39|STANDARD_ERROR_OF_MEAN|3.53||0.46|ONE_SIDED|97.5|-6.58||||t-test, 1 sided|||The difference between treatment groups for the percent of hemoglobin measurements within 10.0 to 11.0 g/dL during the evaluation period was tested using a 1-sided t-test with a significance level of 0.025.|||-6.58|0.46
72539187|NCT00069160|144608111|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||t-test, 2 sided|||||||>.05
72539188|NCT03747939|144608128|SUPERIORITY||Adjusted difference in proportions|18.5||||0.0008|TWO_SIDED|95.0|8.9|28.1|||Cochran-Mantel-Haenszel|Two-sided p-value adjusted for prior/concomitant use of csDMARD and baseline glucocorticosteroid use, normalized via Wilson-Hilferty transformation.|Apremilast - Placebo|Adjusted difference in proportions is the weighted average of the treatment differences across strata formed by two stratification factors, prior/concomitant use of csDMARD and baseline glucocorticosteroid use per Interactive Web Response System (IWRS) data, using Cochran-Mantel-Haenszel (CMH) weights. Two-sided 95% CI is based on a normal approximation to the weighted average.||28.1|8.9|0.0008
72539189|NCT03747939|144608129|SUPERIORITY||Adjusted difference in proportions|18.6||||0.0017|TWO_SIDED|95.0|7.0|30.2|||Cochran-Mantel-Haenszel|Two-sided p-value adjusted for prior/concomitant use of csDMARD and baseline glucocorticosteroid use, normalized via Wilson-Hilferty transformation.|Apremilast - Placebo|Adjusted difference in proportions is the weighted average of the treatment differences across strata formed by two stratification factors, prior/concomitant use of csDMARD and baseline glucocorticosteroid use per IWRS data, using CMH weights. Two-sided 95% CI is based on a normal approximation to the weighted average.||30.2|7.0|0.0017
72539190|NCT03747939|144608130|SUPERIORITY||Adjusted difference in proportions|5.1||||0.3539|TWO_SIDED|95.0|-5.8|16.0|||Cochran-Mantel-Haenszel|Two-sided p-value adjusted for prior/concomitant use of csDMARD and baseline glucocorticosteroid use, normalized via Wilson-Hilferty transformation.|Apremilast - Placebo|Adjusted difference in proportions is the weighted average of the treatment differences across strata formed by two stratification factors, prior/concomitant use of csDMARD and baseline glucocorticosteroid use per IWRS data, using CMH weights. Two-sided 95% CI is based on a normal approximation to the weighted average.||16.0|-5.8|0.3539
72539191|NCT03747939|144608131|SUPERIORITY||Adjusted difference in proportions|22.1||||0.0003|TWO_SIDED|95.0|10.4|33.7|||Cochran-Mantel-Haenszel|Two-sided p-value adjusted for prior/concomitant use of csDMARD and baseline glucocorticosteroid use, normalized via Wilson-Hilferty transformation.|Apremilast - Placebo|Adjusted difference in proportions is the weighted average of the treatment differences across strata formed by two stratification factors, prior/concomitant use of csDMARD and baseline glucocorticosteroid use per IWRS data, using CMH weights. Two-sided 95% CI is based on a normal approximation to the weighted average.||33.7|10.4|0.0003
72539192|NCT03747939|144608132|SUPERIORITY||Adjusted difference in proportions|11.8||||0.0286|TWO_SIDED|95.0|1.7|22.0|||Cochran-Mantel-Haenszel|Two-sided p-value adjusted for prior/concomitant use of csDMARD and baseline glucocorticosteroid use, normalized via Wilson-Hilferty transformation.|Apremilast - Placebo|Adjusted difference in proportions is the weighted average of the treatment differences across strata formed by two stratification factors, prior/concomitant use of csDMARD and baseline glucocorticosteroid use per IWRS data, using CMH weights. Two-sided 95% CI is based on a normal approximation to the weighted average.||22.0|1.7|0.0286
72539193|NCT03747939|144608133|SUPERIORITY||Adjusted difference in proportions|16.3||||0.0022|TWO_SIDED|95.0|6.9|25.8|||Cochran-Mantel-Haenszel|Two-sided p-value adjusted for prior/concomitant use of csDMARD and baseline glucocorticosteroid use, normalized via Wilson-Hilferty transformation.|Apremilast - Placebo|Adjusted difference in proportions is the weighted average of the treatment differences across strata formed by two stratification factors, prior/concomitant use of csDMARD and baseline glucocorticosteroid use per IWRS data, using CMH weights. Two-sided 95% CI is based on a normal approximation to the weighted average.||25.8|6.9|0.0022
72539194|NCT03747939|144608134|SUPERIORITY||Difference in LS means|-1.03|||<|0.0001|TWO_SIDED|95.0|-1.48|-0.59|||MMRM||Apremilast - Placebo|Difference in LS means is based MMRM of the change from baseline.||-0.59|-1.48|<0.0001
72575288|NCT01338870|144676545|SUPERIORITY_OR_OTHER||LS mean difference|-15.92|STANDARD_ERROR_OF_MEAN|5.678||0.0052|TWO_SIDED|95.0|-27.06|-4.77|||Mixed Models Analysis|||Week 1: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||-4.77|-27.06|0.0052
72409689|NCT04116229|144327732|OTHER|"Alternative hypothesis: higher levels of insulin, a pro-inflammatory marker, will relate to higher levels of putative neuroinflammation in white matter tracts as measured by DBSI hindered fraction after controlling for BMI.~Null hypothesis: Insulin levels will not be related to DBSI HF in white matter tracts after controlling for BMI."|Slope|-0.22|||>|0.5|TWO_SIDED|||||a priori threshold: p \< 0.05|Regression, Linear|||"This is a pilot study with a small sample. Power to detect significant results is therefore low in the current study.~Analyses performed across normal-weight and obese groups."||||>0.5
72539195|NCT03747939|144608135|SUPERIORITY||Adjusted difference in proportions|17.7||||0.0043|TWO_SIDED|95.0|5.7|29.7|||Cochran-Mantel-Haenszel|Two-sided p-value adjusted for prior/concomitant use of csDMARD and baseline glucocorticosteroid use, normalized via Wilson-Hilferty transformation.|Apremilast - Placebo|Adjusted difference in proportions is the weighted average of the treatment differences across strata formed by two stratification factors, prior/concomitant use of csDMARD and baseline glucocorticosteroid use per IWRS data, using CMH weights. Two-sided 95% CI is based on a normal approximation to the weighted average.||29.7|5.7|0.0043
72539196|NCT02494583|144608138|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.03918|TWO_SIDED|95.0|0.7|1.02||One-sided p-value based on log-rank test with stratification.|Regression, Cox||Since stratified analyses could be based on collapsing strata with insufficient number of participants or events, strata were pooled in some cases based on clinical judgement and actual counts.|PFS in CPS ≥1 participants of the pembro combo arm was compared to PFS in CPS ≥1 participants of the SOC arm to address the first primary hypothesis (superiority to SOC). The comparison was based on a Cox regression model with Efron's method of tie handling with treatment as a covariate with stratification according to geographic region, disease status, and fluoropyrimidine treatment.||1.02|0.70|0.03918
72539197|NCT02494583|144608139|SUPERIORITY||Hazard Ratio (HR)|0.85||||0.04611|TWO_SIDED|95.0|0.7|1.03||One-sided p-value based on log-rank test with stratification.|Regression, Cox||Since stratified analyses could be based on collapsing strata with insufficient number of participants or events, strata were pooled in some cases based on clinical judgement and actual counts.|OS in CPS ≥1 participants of the pembro combo arm was compared to OS in CPS ≥1 participants of the SOC arm to address the second primary hypothesis (superiority to SOC). The comparison was based on a Cox regression model with Efron's method of tie handling with treatment as a covariate with stratification according to geographic region, disease status, and Fluoropyrimidine treatment.||1.03|0.70|0.04611
72539198|NCT02494583|144608140|SUPERIORITY||Hazard Ratio (HR)|0.85||||0.15804|TWO_SIDED|95.0|0.62|1.17||One-sided p-value based on log-rank test with stratification.|Regression, Cox||Since stratified analyses could be based on collapsing strata with insufficient number of participants or events, strata were pooled in some cases based on clinical judgement and actual counts.|OS in CPS ≥10 participants of the pembro combo arm was compared to OS in CPS ≥10 participants of the SOC arm to address the third primary hypothesis (superiority to SOC). The comparison was based on a Cox regression model with Efron's method of tie handling with treatment as a covariate with stratification according to geographic region, disease status, and Fluoropyrimidine treatment.||1.17|0.62|0.15804
72539199|NCT02494583|144608141|NON_INFERIORITY|Pre-specified non-inferiority margin: if the upper bound of the confidence interval (based on the alpha level allocated to the analysis) for the hazard ratio (\[HR\], pembro mono arm vs SOC) is \< 1.2, the pembro mono arm could be considered as non-inferior to the SOC arm in terms of OS.|Hazard Ratio (HR)|0.91|||||TWO_SIDED|99.2|0.69|1.18|||||Since stratified analyses could be based on collapsing strata with insufficient number of participants or events, strata were pooled in some cases based on clinical judgement and actual counts.|OS in CPS ≥1 participants of the pembro mono arm was compared to OS in CPS ≥1 participants of the SOC arm to address the fourth primary hypothesis (non-inferiority to SOC). The comparison was based on a Cox regression model with Efron's method of tie handling with treatment as a covariate with stratification according to geographic region, disease status, and Fluoropyrimidine treatment.||1.18|0.69|
72539200|NCT02494583|144608141|SUPERIORITY||Hazard Ratio (HR)|0.91||||0.16205|TWO_SIDED|95.0|0.74|1.1||One-sided p-value based on log-rank test with stratification.|Regression, Cox||Since stratified analyses could be based on collapsing strata with insufficient number of participants or events, strata were pooled in some cases based on clinical judgement and actual counts.|OS in CPS ≥1 participants of the pembro mono arm was compared to OS in CPS ≥1 participants of the SOC arm to address the fifth primary hypothesis (superiority to SOC). The comparison was based on a Cox regression model with Efron's method of tie handling with treatment as a covariate with stratification according to geographic region, disease status, and Fluoropyrimidine treatment.||1.10|0.74|0.16205
72575289|NCT01338870|144676545|SUPERIORITY_OR_OTHER||LS mean difference|-21.09|STANDARD_ERROR_OF_MEAN|5.712||0.0002|TWO_SIDED|95.0|-32.3|-9.88|||Mixed Models Analysis|||Week 1: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||-9.88|-32.30|0.0002
72539201|NCT02494583|144608142|SUPERIORITY||Hazard Ratio (HR)|0.69||||0.01491|TWO_SIDED|95.0|0.49|0.97||One-sided p-value based on log-rank test with stratification.|Regression, Cox||Since stratified analyses could be based on collapsing strata with insufficient number of participants or events, strata were pooled in some cases based on clinical judgement and actual counts.|OS in CPS ≥10 participants of the pembro mono arm was compared to OS in CPS ≥10 participants of the SOC arm to address the sixth primary hypothesis (superiority to SOC). The comparison was based on a Cox regression model with Efron's method of tie handling with treatment as a covariate with stratification according to geographic region, disease status, and Fluoropyrimidine treatment.||0.97|0.49|0.01491
72539202|NCT02494583|144608143|OTHER||Difference in ORR Percentage|11.5||||0.00447|TWO_SIDED|95.0|2.9|20.0||No formal hypothesis testing performed; nominal p-value provided for treatment comparison.|Miettinen & Nurminen method||Since stratified analyses could be based on collapsing strata with insufficient number of participants or events, strata were pooled in some cases based on clinical judgement and actual counts.|ORR in CPS ≥1 participants of the pembro combo arm was compared to ORR in CPS ≥1 participants of the SOC arm based on Miettinen \& Nurminen method stratified by geographic region, disease status, and Fluoropyrimidine treatment.||20.0|2.9|0.00447
72539203|NCT02494583|144608145|OTHER||Difference in ORR Percentage|-22.3|||>|0.99999|TWO_SIDED|95.0|-29.6|-14.9||No formal hypothesis testing performed; nominal p-value provided for treatment comparison.|Miettinen & Nurminen method||Since stratified analyses could be based on collapsing strata with insufficient number of participants or events, strata were pooled in some cases based on clinical judgement and actual counts.|ORR in CPS ≥1 participants of the pembro mono arm was compared to ORR in CPS ≥1 participants of the SOC arm based on Miettinen \& Nurminen method stratified by geographic region, disease status, and Fluoropyrimidine treatment.||-14.9|-29.6|>0.99999
72539204|NCT02494583|144608147|OTHER||Hazard Ratio (HR)|1.64||||1|TWO_SIDED|95.0|1.36|1.98||No formal hypothesis testing performed; nominal p-value provided for treatment comparison.|Regression, Cox||Since stratified analyses could be based on collapsing strata with insufficient number of participants or events, strata were pooled in some cases based on clinical judgement and actual counts.|PFS in CPS ≥1 participants of the pembro mono arm was compared to PFS in CPS ≥1 participants of the SOC arm based on a Cox regression model with Efron's method of tie handling with treatment as a covariate with stratification according to geographic region, disease status, and fluoropyrimidine treatment.||1.98|1.36|1.00000
72539205|NCT02494583|144608148|OTHER||Difference in LS Means|-0.16||||0.948|TWO_SIDED|95.0|-5.01|4.69||No formal hypothesis testing performed; nominal p-value provided for treatment comparison.|cLDA||Stratified analyses could be based on collapsing strata with insufficient number of participants or events; strata were pooled in some cases based on clinical judgement and actual counts.|Change from baseline to Week 18 in EORTC-QLQ-C30 GHS/QoL combined score was compared between all participants of the pembro mono arm and the SOC arm. Comparison based on constrained longitudinal data analysis (cLDA) model with GHS/QoL score as response variable and treatment by visit interaction and stratification factors (geographic region, disease status, and fluoropyrimidine treatment) as covariates.||4.69|-5.01|0.948
72539206|NCT02494583|144608149|OTHER||Difference in LS Means|1.98||||0.368|TWO_SIDED|95.0|-2.34|6.31||No formal hypothesis testing performed; nominal p-value provided for treatment comparison.|cLDA||Since stratified analyses could be based on collapsing strata with insufficient number of participants or events, strata were pooled in some cases based on clinical judgement and actual counts.|Change from baseline to Week 18 in EORTC-QLQ-C30 GHS/QoL combined score was compared between all participants of the pembro combo arm and the SOC arm. Comparison based on cLDA model with GHS/QoL score as response variable and treatment by visit interaction and stratification factors (geographic region, disease status, and fluoropyrimidine treatment) as covariates.||6.31|-2.34|0.368
72539207|NCT02494583|144608150|OTHER||Difference in LS Means|2.35||||0.308|TWO_SIDED|95.0|-2.18|6.89||No formal hypothesis testing performed; nominal p-value provided for treatment comparison.|cLDA||Since stratified analyses could be based on collapsing strata with insufficient number of participants or events, strata were pooled in some cases based on clinical judgement and actual counts.|Change from baseline to Week 18 in EORTC-QLQ-STO22 Pain symptom subscale score was compared between all participants of the pembro mono arm and the SOC arm. Comparison based on cLDA model with GHS/QoL score as response variable and treatment by visit interaction and stratification factors (geographic region, disease status, and fluoropyrimidine treatment) as covariates.||6.89|-2.18|0.308
72539208|NCT02494583|144608151|OTHER||Difference in LS Means|-6.56||||0.001|TWO_SIDED|95.0|-10.55|-2.58||No formal hypothesis testing performed; nominal p-value provided for treatment comparison.|cLDA||Since stratified analyses could be based on collapsing strata with insufficient number of participants or events, strata were pooled in some cases based on clinical judgement and actual counts.|Change from baseline to Week 18 in EORTC-QLQ-STO22 Pain symptom subscale score was compared between all participants of the pembro combo arm and the SOC arm. Comparison based on cLDA model with GHS/QoL score as response variable and treatment by visit interaction and stratification factors (geographic region, disease status, and fluoropyrimidine treatment) as covariates.||-2.58|-10.55|0.001
72539209|NCT02180659|144608154|NON_INFERIORITY|"For the primary efficacy variable, a test of non-inferiority of Probuphine (active) versus SL BPN (control) responders was conducted. A non-inferiority margin of 20% was employed to define noninferiority.~A Confidence Interval (CI) for the difference in proportions was calculated, and non-inferiority was established if the lower bound of the 95% CI for the difference of proportions (Probuphine - SL BPN) was greater than -0.20."|Difference in Response Rate|0.088|||<|0.001|TWO_SIDED|95.0|0.009|0.167|||Chi-squared|||||0.167|0.009|<.001
72539210|NCT02180659|144608155|SUPERIORITY|At month 6 comparing those subject with no illicit drug use.||||||0.306|||||||Chi-squared|||||||0.306
72575290|NCT01338870|144676545|SUPERIORITY_OR_OTHER||LS mean difference|0.08|STANDARD_ERROR_OF_MEAN|5.852||0.9893|TWO_SIDED|95.0|-11.41|11.56|||Mixed Models Analysis|||Week 2: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||11.56|-11.41|0.9893
72539211|NCT02180659|144608156|SUPERIORITY|||||||0.037|||||||Log Rank|||||||.037
72539212|NCT02180659|144608158|SUPERIORITY||Mean Difference (Final Values)|-0.4||||0.832|TWO_SIDED||||||ANOVA|||Comparing change in baseline to week 24 between the two groups.||||0.832
72539213|NCT02180659|144608159|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.922|TWO_SIDED||||||ANOVA|||||||0.922
72575291|NCT01338870|144676545|SUPERIORITY_OR_OTHER||LS mean difference|-4.14|STANDARD_ERROR_OF_MEAN|5.814||0.4767|TWO_SIDED|95.0|-15.55|7.27|||Mixed Models Analysis|||Week 2: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||7.27|-15.55|0.4767
72575292|NCT01338870|144676545|SUPERIORITY_OR_OTHER||LS mean difference|-2.87|STANDARD_ERROR_OF_MEAN|5.816||0.6222|TWO_SIDED|95.0|-14.28|8.55|||Mixed Models Analysis|||Week 2: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||8.55|-14.28|0.6222
72575293|NCT01338870|144676545|SUPERIORITY_OR_OTHER||LS mean difference|-13.88|STANDARD_ERROR_OF_MEAN|5.744||0.0159|TWO_SIDED|95.0|-25.16|-2.61|||Mixed Models Analysis|||Week 2: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||-2.61|-25.16|0.0159
72627371|NCT05136170|144783688|SUPERIORITY|||||||0.727||||||p-value corresponds to a non-parametric Mann-Whitney-Wilcoxon (Wilcoxon rank sum) test of the comparisons between Cenegermin and Vehicle in all patients.|Wilcoxon (Mann-Whitney)|||Herein analysis for Severity - Week 16 (Visit 6) was reported.||||0.727
72627372|NCT05136170|144783688|SUPERIORITY|||||||0.342||||||p-value corresponds to a non-parametric Mann-Whitney-Wilcoxon (Wilcoxon rank sum) test of the comparisons between Cenegermin and Vehicle in all patients.|Wilcoxon (Mann-Whitney)|||Herein analysis for Frequency - Week 8 (Visit 4) was reported.||||0.342
72539214|NCT02180659|144608160|SUPERIORITY||Mean Difference (Final Values)|-0.6||||0.425|TWO_SIDED||||||ANOVA|||||||0.425
72539215|NCT02180659|144608161|SUPERIORITY||Median Difference (Final Values)|-1.3||||0.505|TWO_SIDED||||||ANOVA|||Comparing change in baseline to week 24 between the two groups.||||0.505
72627373|NCT05136170|144783688|SUPERIORITY|||||||0.821||||||p-value corresponds to a non-parametric Mann-Whitney-Wilcoxon (Wilcoxon rank sum) test of the comparisons between Cenegermin and Vehicle in all patients.|Wilcoxon (Mann-Whitney)|||Herein analysis for Frequency - Week 12 (Visit 5) was reported.||||0.821
72627374|NCT05136170|144783688|SUPERIORITY|||||||0.926||||||p-value corresponds to a non-parametric Mann-Whitney-Wilcoxon (Wilcoxon rank sum) test of the comparisons between Cenegermin and Vehicle in all patients.|Wilcoxon (Mann-Whitney)|||Herein analysis for Frequency - Week 16 (Visit 6) was reported.||||0.926
72627375|NCT05136170|144783689|SUPERIORITY|||||||0.0344||||||p-value corresponds to Chi-square test of the comparisons between Cenegermin and Vehicle in all patients.|Chi-squared|||Herein analysis for Worsening in symptom scores (SANDE global score) - Week 4 (Visit 3) was reported.||||0.0344
72627376|NCT05136170|144783689|SUPERIORITY|||||||1||||||p-value corresponds to a Fisher's exact test of the comparisons between Cenegermin and Vehicle in all patients.|Fisher Exact|||Herein analysis for NEI score \>= 50% - Week 4 (Visit 3) was reported.||||1
72539216|NCT00865306|144608212|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Chi-squared|||||||<.05
72539217|NCT00865306|144608213|SUPERIORITY_OR_OTHER||||||<|0.01||95.0|||||Chi-squared|||||||<.01
72575294|NCT01338870|144676545|SUPERIORITY_OR_OTHER||LS mean difference|-18.69|STANDARD_ERROR_OF_MEAN|5.735||0.0012|TWO_SIDED|95.0|-29.95|-7.44|||Mixed Models Analysis|||Week 2: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||-7.44|-29.95|0.0012
72575295|NCT01338870|144676545|SUPERIORITY_OR_OTHER||LS mean difference|3.86|STANDARD_ERROR_OF_MEAN|5.895||0.5125|TWO_SIDED|95.0|-7.71|15.43|||Mixed Models Analysis|||Week 4: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||15.43|-7.71|0.5125
72627377|NCT05136170|144783689|SUPERIORITY|||||||0.0235||||||p-value corresponds to Chi-square test of the comparisons between Cenegermin and Vehicle in all patients.|Chi-squared|||Herein analysis for Worsening in symptom scores and/or NEI score \>= 50 - Week 4 (Visit 3) was reported.||||0.0235
72627378|NCT05136170|144783690|SUPERIORITY|||||||0.888||||||p-value corresponds to a two sample (independent group) t-test of the comparisons between Cenegermin and Vehicle in all patients.|t-test, 2 sided|||Herein analysis for QoL (Impact on Daily Activities) - Week 4 (Visit 3) was reported.||||0.888
72627379|NCT05136170|144783690|SUPERIORITY|||||||0.651||||||p-value corresponds to a two sample (independent group) t-test of the comparisons between Cenegermin and Vehicle in all patients.|t-test, 2 sided|||Herein analysis for QoL (Impact on Daily Activities) - Week 8 (Visit 4) was reported.||||0.651
72627380|NCT05136170|144783690|SUPERIORITY|||||||0.267||||||p-value corresponds to a non-parametric Mann-Whitney-Wilcoxon (Wilcoxon rank sum) test of the comparisons between Cenegermin and Vehicle in all patients.|Wilcoxon (Mann-Whitney)|||Herein analysis for QoL (Impact on Daily Activities) - Week 12 (Visit 5) was reported.||||0.267
72539218|NCT02058368|144608216|SUPERIORITY||Mean Difference (Final Values)|0.79||||0.069|TWO_SIDED|95.0|-0.06|1.65||Change from Baseline = Treatment + Country + Baseline Value. P-values for Dut 0.5 mg + Tam 0.2 mg versus Placebo + Tam 0.2mg are based on t-tests from the general linear model. Reported means are model based adjusted means.|General linear model||Estimates are based on adjusted means from the general linear model. The adjusted mean difference was based on combination minus tamsulosin monotherapy for Month 3.|||1.65|-0.06|0.069
72539219|NCT02058368|144608216|SUPERIORITY||Mean Difference (Final Values)|0.37||||0.43|TWO_SIDED|95.0|-0.55|1.29||Change from Baseline = Treatment + Country + Baseline Value. P-values for Dut 0.5 mg + Tam 0.2 mg versus Placebo + Tam 0.2 mg are based on t-tests from the general linear model. Reported means are model based adjusted means.|General linear model||Estimates are based on adjusted means from the general linear model. The adjusted mean difference was based on combination minus tamsulosin monotherapy for Month 6.|||1.29|-0.55|0.43
72539220|NCT02058368|144608216|SUPERIORITY||Mean Difference (Final Values)|-0.14||||0.76|TWO_SIDED|95.0|-1.05|0.77||Change from Baseline = Treatment + Country + Baseline Value. P-values for Dut 0.5 mg + Tam 0.2 mg versus Placebo + Tam 0.2 mg are based on t-tests from the general linear model. Reported means are model based adjusted means.|General linear model||Estimates are based on adjusted means from the general linear model. The adjusted mean difference was based on combination minus tamsulosin monotherapy for Month 9.|||0.77|-1.05|0.76
72539221|NCT02058368|144608216|SUPERIORITY||Mean Difference (Final Values)|-0.37||||0.41|TWO_SIDED|95.0|-1.27|0.53||Change from Baseline = Treatment + Country + Baseline Value. P-values for Dut 0.5 mg + Tam 0.2 mg versus Placebo + Tam 0.2 mg are based on t-tests from the general linear model. Reported means are model based adjusted means|General linear model||Estimates are based on adjusted means from the general linear model. The adjusted mean difference was based on combination minus tamsulosin monotherapy for Month 12.|||0.53|-1.27|0.41
72539222|NCT02058368|144608216|SUPERIORITY||Mean Difference (Final Values)|-0.95||||0.039|TWO_SIDED|95.0|-1.85|-0.05||Change from Baseline = Treatment + Country + Baseline Value. P-values for Dut 0.5 mg+Tam 0.2 mg versus Placebo+ Tam 0.2 mg are based on t-tests from the general linear model. Reported means are model based adjusted means|General linear model||Estimates are based on adjusted means from the general linear model. The adjusted mean difference was based on combination minus tamsulosin monotherapy for Month 15.|||-0.05|-1.85|0.039
72539223|NCT02058368|144608216|SUPERIORITY||Mean Difference (Final Values)|-0.7||||0.15|TWO_SIDED|95.0|-1.65|0.26||Change from Baseline = Treatment + Country + Baseline Value. P-values for Dut 0.5 mg+Tam 0.2 mg versus Placebo+ Tam 0.2 mg are based on t-tests from the general linear model. Reported means are model based adjusted means|General linear model||Estimates are based on adjusted means from the general linear model. The adjusted mean difference was based on combination minus tamsulosin monotherapy for Month 18.|||0.26|-1.65|0.15
72539224|NCT02058368|144608216|SUPERIORITY||Mean Difference (Final Values)|-0.72||||0.15|TWO_SIDED|95.0|-1.68|0.25||Change from Baseline = Treatment + Country + Baseline Value. P-values for Dut 0.5 mg+Tam 0.2 mg versus Placebo+ Tam 0.2 mg are based on t-tests from the general linear model. Reported means are model based adjusted means|General linear model||Estimates are based on adjusted means from the general linear model. The adjusted mean difference was based on combination minus tamsulosin monotherapy for Month 21.|||0.25|-1.68|0.15
72539225|NCT02058368|144608216|SUPERIORITY||Mean Difference (Final Values)|-1.43||||0.004|TWO_SIDED|95.0|-2.4|-0.46||Change from Baseline = Treatment + Country + Baseline Value. P-values for Dut 0.5 mg+Tam 0.2 mg versus Placebo+ Tam 0.2 mg are based on t-tests from the general linear model. Reported means are model based adjusted means|General linear model||Estimates are based on adjusted means from the general linear model. The adjusted mean difference was based on combination minus tamsulosin monotherapy for Month 24.|||-0.46|-2.40|0.004
72539226|NCT02058368|144608217|SUPERIORITY||Mean Difference (Final Values)|-23.0|STANDARD_ERROR_OF_MEAN|1.48|<|0.001|TWO_SIDED|95.0|-25.9|-20.1||Estimates are based on the adjusted means from the general linear model: Log(Post-Baseline Prostate Volume / Baseline Prostate Volume) = Log(Baseline Prostate Volume) + Treatment + Country. P-values are based on t-tests from the general linear model.|General linear model||The adjusted mean estimates, adjusted mean differences, and confidence intervals are expressed in terms of percentage change from Baseline for Month 12.|||-20.1|-25.9|<.001
72539227|NCT02058368|144608217|SUPERIORITY|Estimates are based on the adjusted means from the general linear model: Log(Post-Baseline Prostate Volume / Baseline Prostate Volume) = Log(Baseline Prostate Volume) + Treatment + Country. P-values are based on t-tests from the general linear model.|Mean Difference (Final Values)|-28.4|STANDARD_ERROR_OF_MEAN|1.65|<|0.001|TWO_SIDED|95.0|-31.7|-25.2|||General linear model||The adjusted mean estimates, adjusted mean differences, and confidence intervals are expressed in terms of percentage change from Baseline for Month 24|||-25.2|-31.7|<.001
72539228|NCT02058368|144608218|SUPERIORITY|||||||0.91||||||P-value for IPSS improvement \>= 3 units has been presented for Month 3|Mantel Haenszel|||||||0.91
72539229|NCT02058368|144608218|SUPERIORITY|||||||0.31||||||P-value for IPSS improvement \>= 2 units has been presented for Month 3|Mantel Haenszel|||||||0.31
72539230|NCT02058368|144608218|SUPERIORITY|||||||0.42||||||P-value for IPSS improvement \>= 25 percent has been presented for Month 3|Mantel Haenszel|||||||0.42
72539231|NCT02058368|144608218|SUPERIORITY|||||||0.92||||||P-value for IPSS improvement \>= 3 units has been presented for Month 6|Mantel Haenszel|||||||0.92
72539232|NCT02058368|144608218|SUPERIORITY|||||||0.89||||||P-value for IPSS improvement \>= 2 units has been presented for Month 6|Mantel Haenszel|||||||0.89
72539233|NCT02058368|144608218|SUPERIORITY|||||||0.81||||||P-value for IPSS improvement \>= 25 percent has been presented for Month 6|Mantel Haenszel|||||||0.81
72539234|NCT02058368|144608218|SUPERIORITY|||||||0.08||||||P-value for IPSS improvement \>= 3 units has been presented for Month 9|Mantel Haenszel|||||||0.080
72539235|NCT02058368|144608218|SUPERIORITY|||||||0.42||||||P-value for IPSS improvement \>= 2 units has been presented for Month 9|Mantel Haenszel|||||||0.42
72539236|NCT02058368|144608218|SUPERIORITY|||||||0.06||||||P-value for IPSS improvement \>= 25 percent has been presented for Month 9|Mantel Haenszel|||||||0.060
72539237|NCT02058368|144608218|SUPERIORITY|||||||0.14||||||P-value for IPSS improvement \>= 3 units has been presented for Month 12|Mantel Haenszel|||||||0.14
72539238|NCT02058368|144608218|SUPERIORITY|||||||0.26||||||P-value for IPSS improvement \>= 2 units has been presented for Month 12|Mantel Haenszel|||||||0.26
72539239|NCT02058368|144608218|SUPERIORITY|||||||0.048||||||P-value for IPSS improvement \>= 25 percent has been presented for Month 12|Mantel Haenszel|||||||0.048
72539240|NCT02058368|144608218|SUPERIORITY|||||||0.17||||||P-value for IPSS improvement \>= 3 units has been presented for Month 15|Mantel Haenszel|||||||0.17
72539241|NCT02058368|144608218|SUPERIORITY|||||||0.11||||||P-value for IPSS improvement \>= 2 units has been presented for Month 15|Mantel Haenszel|||||||0.11
72539242|NCT02058368|144608218|SUPERIORITY|||||||0.022||||||P-value for IPSS improvement \>= 25 percent has been presented for Month 15|Mantel Haenszel|||||||0.022
72539243|NCT02058368|144608218|SUPERIORITY|||||||0.18||||||P-value for IPSS improvement \>= 3 units has been presented for Month 18|Mantel Haenszel|||||||0.18
72539244|NCT02058368|144608218|SUPERIORITY|||||||0.19||||||P-value for IPSS improvement \>= 2 units has been presented for Month 18|Mantel Haenszel|||||||0.19
72539245|NCT02058368|144608218|SUPERIORITY|||||||0.28||||||P-value for IPSS improvement \>= 25 percent has been presented for Month 18|Mantel Haenszel|||||||0.28
72539246|NCT02058368|144608218|SUPERIORITY|||||||0.39||||||P-value for IPSS improvement \>= 3 units has been presented for Month 21|Mantel Haenszel|||||||0.39
72539247|NCT02058368|144608218|SUPERIORITY|||||||0.42||||||P-value for IPSS improvement \>= 2 units has been presented for Month 21|Mantel Haenszel|||||||0.42
72539248|NCT02058368|144608218|SUPERIORITY|||||||0.084||||||P-value for IPSS improvement \>= 25 percent has been presented for Month 21|Mantel Haenszel|||||||0.084
72539249|NCT02058368|144608218|SUPERIORITY|||||||0.016||||||P-value for IPSS improvement \>= 3 units has been presented for Month 24|Mantel Haenszel|||||||0.016
72539250|NCT02058368|144608218|SUPERIORITY|||||||0.047||||||P-value for IPSS improvement \>= 2 units has been presented for Month 24|Mantel Haenszel|||||||0.047
72539251|NCT02058368|144608218|SUPERIORITY|||||||0.007||||||P-value for IPSS improvement \>= 25 percent has been presented for Month 24|Mantel Haenszel|||||||0.007
72539252|NCT02058368|144608219|SUPERIORITY||Mean Difference (Final Values)|0.91|STANDARD_ERROR_OF_MEAN|0.33||0.006|TWO_SIDED|95.0|0.26|1.56||Estimates are based on the adjusted means from the general linear model: Change from Baseline = Treatment + Country + Baseline Value for Month 6|General linear model||The adjusted mean difference was based on Dut+Tam minus Tam|||1.56|0.26|0.006
72539253|NCT02058368|144608219|SUPERIORITY||Mean Difference (Final Values)|1.0|STANDARD_ERROR_OF_MEAN|0.35||0.005|TWO_SIDED|95.0|0.3|1.69||Estimates are based on the adjusted means from the general linear model: Change from Baseline = Treatment + Country + Baseline Value for Month 12|General linear model||The adjusted mean difference was based on Dut+Tam minus Tam|||1.69|0.30|0.005
72575296|NCT01338870|144676545|SUPERIORITY_OR_OTHER||LS mean difference|-8.47|STANDARD_ERROR_OF_MEAN|5.815||0.1455|TWO_SIDED|95.0|-19.89|2.94|||Mixed Models Analysis|||Week 4: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||2.94|-19.89|0.1455
72575297|NCT01338870|144676545|SUPERIORITY_OR_OTHER||LS mean difference|0.94|STANDARD_ERROR_OF_MEAN|5.794||0.8712|TWO_SIDED|95.0|-10.43|12.31|||Mixed Models Analysis|||Week 4: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||12.31|-10.43|0.8712
72539254|NCT02058368|144608219|SUPERIORITY||Mean Difference (Final Values)|1.46|STANDARD_ERROR_OF_MEAN|0.42|<|0.001|TWO_SIDED|95.0|0.63|2.29||Estimates are based on the adjusted means from the general linear model: Change from Baseline = Treatment + Country + Baseline Value for Month 18|General linear model||The adjusted mean difference was based on Dut+Tam minus Tam|||2.29|0.63|<.001
72539255|NCT02058368|144608219|SUPERIORITY||Mean Difference (Final Values)|1.34|STANDARD_ERROR_OF_MEAN|0.41||0.001|TWO_SIDED|95.0|0.54|2.15||Estimates are based on the adjusted means from the general linear model: Change from Baseline = Treatment + Country + Baseline Value for Month 24|General linear model||The adjusted mean difference was based on Dut+Tam minus Tam|||2.15|0.54|0.001
72539256|NCT02058368|144608220|SUPERIORITY|||||||0.13||||||P-value for Dut+Tam vs. Tam is based on a Mantel-Haenszel test controlling for country for \>= 3 mL/sec for Month 6|Mantel Haenszel|||||||0.13
72539257|NCT02058368|144608220|SUPERIORITY|||||||0.15||||||P-value for Dut+Tam vs. Tam is based on a Mantel-Haenszel test controlling for country for \>= 30 % for Month 6|Mantel Haenszel|||||||0.15
72539258|NCT02058368|144608220|SUPERIORITY||||||<|0.001||||||P-value for Dut+Tam vs. Tam is based on a Mantel-Haenszel test controlling for country for \>= 3 mL/sec for Month 12|Mantel Haenszel|||||||<.001
72539259|NCT02058368|144608220|SUPERIORITY|||||||0.003||||||P-value for Dut+Tam vs. Tam is based on a Mantel-Haenszel test controlling for country for \>= 30 % for Month 12|Mantel Haenszel|||||||0.003
72539260|NCT02058368|144608220|SUPERIORITY|||||||0.002||||||P-value for Dut+Tam vs. Tam is based on a Mantel-Haenszel test controlling for country for \>= 3 mL/sec for Month 18|Mantel Haenszel|||||||0.002
72539261|NCT02058368|144608220|SUPERIORITY|||||||0.009||||||P-value for Dut+Tam vs. Tam is based on a Mantel-Haenszel test controlling for country for \>= 30 % for Month 18|Mantel Haenszel|||||||0.009
72539262|NCT02058368|144608220|SUPERIORITY||||||<|0.001||||||P-value for Dut+Tam vs. Tam is based on a Mantel-Haenszel test controlling for country for \>= 3 mL/sec for Month 24|Mantel Haenszel|||||||<.001
72539263|NCT02058368|144608220|SUPERIORITY||||||<|0.001||||||P-value for Dut+Tam vs. Tam is based on a Mantel-Haenszel test controlling for country for \>= 30 % for Month 24|Mantel Haenszel|||||||<.001
72539264|NCT02058368|144608221|SUPERIORITY||Cox Proportional Hazard|0.27||||0.012|TWO_SIDED|95.0|0.09|0.81||Relative Risk (hazard ratio) for Dut+Tam vs. Tam is based on the Cox Proportional Hazards Model with stratification by country.|Log Rank|||||0.81|0.09|0.012
72539265|NCT02058368|144608222|SUPERIORITY||Cox Proportional Hazard|0.15||||0.005|TWO_SIDED|95.0|0.03|0.68||Relative Risk (hazard ratio) for Dut+Tam vs. Tam is based on the Cox Proportional Hazards Model with stratification by country.|Log Rank|||||0.68|0.03|0.005
72539266|NCT02058368|144608223|SUPERIORITY||Cox Proportional Hazard|0.69||||0.68|TWO_SIDED|95.0|0.11|4.11||Relative Risk (hazard ratio) for Dut+Tam vs. Tam is based on the Cox Proportional Hazards Model with stratification by country.|Log Rank|||||4.11|0.11|0.68
72539267|NCT02058368|144608224|SUPERIORITY||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.1||0.83|TWO_SIDED|95.0|-0.17|0.21||Estimates are based on the adjusted means from the general linear model: Change from Baseline =Treatment + Country + Baseline Value for Month 3|General linear model||The adjusted mean difference was based on Dut+Tam minus Tam|||0.21|-0.17|0.83
72539268|NCT02058368|144608224|SUPERIORITY||Mean Difference (Final Values)|0.16|STANDARD_ERROR_OF_MEAN|0.1||0.11|TWO_SIDED|95.0|-0.04|0.36||Estimates are based on the adjusted means from the general linear model: Change from Baseline =Treatment + Country + Baseline Value for Month 6|General linear model||The adjusted mean difference was based on Dut+Tam minus Tam|||0.36|-0.04|0.11
72539269|NCT02058368|144608224|SUPERIORITY||Mean Difference (Final Values)|0.13|STANDARD_ERROR_OF_MEAN|0.11||0.21|TWO_SIDED|95.0|-0.07|0.34||Estimates are based on the adjusted means from the general linear model: Change from Baseline =Treatment + Country + Baseline Value for Month 9|General linear model||The adjusted mean difference was based on Dut+Tam minus Tam|||0.34|-0.07|0.21
72539270|NCT02058368|144608224|SUPERIORITY||Mean Difference (Final Values)|-0.03|STANDARD_ERROR_OF_MEAN|0.1||0.8|TWO_SIDED|95.0|-0.23|0.18||Estimates are based on the adjusted means from the general linear model: Change from Baseline =Treatment + Country + Baseline Value for Month 12|General linear model||The adjusted mean difference was based on Dut+Tam minus Tam|||0.18|-0.23|0.80
72539271|NCT02058368|144608224|SUPERIORITY||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.1||0.37|TWO_SIDED|95.0|-0.3|0.11||Estimates are based on the adjusted means from the general linear model: Change from Baseline = Treatment + Country + Baseline Value for Month 15|General linear model||The adjusted mean difference was based on Dut+Tam minus Tam|||0.11|-0.30|0.37
72539272|NCT02058368|144608224|SUPERIORITY||Mean Difference (Final Values)|-0.08|STANDARD_ERROR_OF_MEAN|0.11||0.44|TWO_SIDED|95.0|-0.3|0.13||Estimates are based on the adjusted means from the general linear model: Change from Baseline = Treatment + Country + Baseline Value for Month 18|General linear model||The adjusted mean difference was based on Dut+Tam minus Tam|||0.13|-0.30|0.44
72539273|NCT02058368|144608224|SUPERIORITY||Mean Difference (Final Values)|0.06|STANDARD_ERROR_OF_MEAN|0.11||0.6|TWO_SIDED|95.0|-0.16|0.28||Estimates are based on the adjusted means from the general linear model: Change from Baseline = Treatment + Country + Baseline Value for Month 21|General linear model||The adjusted mean difference was based on Dut+Tam minus Tam|||0.28|-0.16|0.60
72539274|NCT02058368|144608224|SUPERIORITY||Mean Difference (Final Values)|-0.15|STANDARD_ERROR_OF_MEAN|0.11||0.16|TWO_SIDED|95.0|-0.37|0.06||Estimates are based on the adjusted means from the general linear model: Change from Baseline = Treatment + Country + Baseline Value for Month 24|General linear model||The adjusted mean difference was based on Dut+Tam minus Tam|||0.06|-0.37|0.16
72539275|NCT02058368|144608225|SUPERIORITY||Mean Difference (Final Values)|0.25|STANDARD_ERROR_OF_MEAN|0.18||0.17|TWO_SIDED|95.0|-0.11|0.62||Estimates are based on the adjusted means from the general linear model: Change from Baseline = Treatment + Country + Baseline Value. P-values for Dut+Tam versus Tam are based on t-tests from the general linear model.|General linear model||The adjusted mean difference was based on Dut+Tam minus Tam for Month 3|||0.62|-0.11|0.17
72539276|NCT02058368|144608225|SUPERIORITY||Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|0.2||0.33|TWO_SIDED|95.0|-0.2|0.59||Estimates are based on the adjusted means from the general linear model: Change from Baseline = Treatment + Country + Baseline Value. P-values for Dut+Tam versus Tam are based on t-tests from the general linear model.|General linear model||The adjusted mean difference was based on Dut+Tam minus Tam for Month 6|||0.59|-0.20|0.33
72539277|NCT02058368|144608225|SUPERIORITY||Mean Difference (Final Values)|0.29|STANDARD_ERROR_OF_MEAN|0.2||0.15|TWO_SIDED|95.0|-0.1|0.68||Estimates are based on the adjusted means from the general linear model: Change from Baseline = Treatment + Country + Baseline Value. P-values for Dut+Tam versus Tam are based on t-tests from the general linear model.|General linear model||The adjusted mean difference was based on Dut+Tam minus Tam for Month 9|||0.68|-0.10|0.15
72539278|NCT02058368|144608225|SUPERIORITY||Mean Difference (Final Values)|0.15|STANDARD_ERROR_OF_MEAN|0.21||0.46|TWO_SIDED|95.0|-0.25|0.55||Estimates are based on the adjusted means from the general linear model: Change from Baseline = Treatment + Country + Baseline Value. P-values for Dut+Tam versus Tam are based on t-tests from the general linear model.|General linear model||The adjusted mean difference was based on Dut+Tam minus Tam for Month 12|||0.55|-0.25|0.46
72539279|NCT02058368|144608225|SUPERIORITY||Median Difference (Final Values)|-0.11|STANDARD_ERROR_OF_MEAN|0.21||0.59|TWO_SIDED|95.0|-0.51|0.29||Estimates are based on the adjusted means from the general linear model: Change from Baseline = Treatment + Country + Baseline Value. P-values for Dut+Tam versus Tam are based on t-tests from the general linear model.|General linear model||The adjusted mean difference was based on Dut+Tam minus Tam for Month 15|||0.29|-0.51|0.59
72539280|NCT02058368|144608225|SUPERIORITY||Mean Difference (Final Values)|-0.12|STANDARD_ERROR_OF_MEAN|0.2||0.56|TWO_SIDED|95.0|-0.52|0.28||Estimates are based on the adjusted means from the general linear model: Change from Baseline = Treatment + Country + Baseline Value. P-values for Dut+Tam versus Tam are based on t-tests from the general linear model.|General linear model||The adjusted mean difference was based on Dut+Tam minus Tam for Month 18|||0.28|-0.52|0.56
72539281|NCT02058368|144608225|SUPERIORITY||Mean Difference (Final Values)|-0.14|STANDARD_ERROR_OF_MEAN|0.21||0.51|TWO_SIDED|95.0|-0.56|0.28||Estimates are based on the adjusted means from the general linear model: Change from Baseline = Treatment + Country + Baseline Value. P-values for Dut+Tam versus Tam are based on t-tests from the general linear model.|General linear model||The adjusted mean difference was based on Dut+Tam minus Tam for Month 21|||0.28|-0.56|0.51
72539282|NCT02058368|144608225|SUPERIORITY||Mean Difference (Final Values)|-0.46|STANDARD_ERROR_OF_MEAN|0.21||0.034|TWO_SIDED|95.0|-0.88|-0.03||Estimates are based on the adjusted means from the general linear model: Change from Baseline = Treatment + Country + Baseline Value. P-values for Dut+Tam versus Tam are based on t-tests from the general linear model.|General linear model||The adjusted mean difference was based on Dut+Tam minus Tam for Month 24|||-0.03|-0.88|0.034
72627381|NCT05136170|144783690|SUPERIORITY|||||||0.459||||||p-value corresponds to a non-parametric Mann-Whitney-Wilcoxon (Wilcoxon rank sum) test of the comparisons between Cenegermin and Vehicle in all patients.|Wilcoxon (Mann-Whitney)|||Herein analysis for QoL (Impact on Daily Activities) - Week 16 (Visit 6) was reported.||||0.459
72627382|NCT05136170|144783690|SUPERIORITY|||||||0.192||||||p-value corresponds to a two sample (independent group) t-test of the comparisons between Cenegermin and Vehicle in all patients.|t-test, 2 sided|||Herein analysis for QoL (Emotional Impact due to Dry Eye) - Week 4 was reported.||||0.192
72627383|NCT05136170|144783690|SUPERIORITY|||||||0.568||||||p-value corresponds to a two sample (independent group) t-test of the comparisons between Cenegermin and Vehicle in all patients.|t-test, 2 sided|||Herein analysis for QoL (Emotional Impact due to Dry Eye) - Week 8 was reported.||||0.568
72539283|NCT02058368|144608226|SUPERIORITY||Mean Difference (Final Values)|-1.02|STANDARD_ERROR_OF_MEAN|0.26|<|0.001|TWO_SIDED|95.0|-1.54|-0.5||Estimates are based on the adjusted means from the general linear model: Change from Baseline =Treatment + Country + Baseline Value.P-values for Dut+Tam versus Tam are based on t-tests from the general linear model for Month 12|General linear model||The adjusted mean difference was based on Dut+Tam minus Tam.|||-0.50|-1.54|<.001
72539284|NCT02058368|144608226|SUPERIORITY||Mean Difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|0.27||0.009|TWO_SIDED|95.0|-1.23|-0.18||Estimates are based on the adjusted means from the general linear model: Change from Baseline = Treatment + Country + Baseline Value. P-values for Dut+Tam versus Tam are based on t-tests from the general linear model for Month 24|General linear model||The adjusted mean difference was based on Dut+Tam minus Tam.|||-0.18|-1.23|0.009
72539285|NCT02058368|144608231|SUPERIORITY||Mean Difference (Final Values)|-1.9|STANDARD_ERROR_OF_MEAN|0.12|<|0.001|TWO_SIDED|95.0|-2.1|-1.6||Estimates are based on the adjusted means from the general linear model: Change from Baseline = Treatment + Baseline Value for Month 6|General linear model||The adjusted mean difference was based on Dut+Tam minus Tam.|||-1.6|-2.1|<.001
72539286|NCT02058368|144608231|SUPERIORITY||Mean Difference (Final Values)|-2.1|STANDARD_ERROR_OF_MEAN|0.11|<|0.001|TWO_SIDED|95.0|-2.3|-1.9||Estimates are based on the adjusted means from the general linear model: Change from Baseline = Treatment + Baseline Value for Month 12|General linear model||The adjusted mean difference was based on Dut+Tam minus Tam.|||-1.9|-2.3|<.001
72539287|NCT02058368|144608231|SUPERIORITY||Mean Difference (Final Values)|-2.7|STANDARD_ERROR_OF_MEAN|0.23|<|0.001|TWO_SIDED|95.0|-3.1|-2.2||Estimates are based on the adjusted means from the general linear model: Change from Baseline =Treatment + Baseline Value for Month 24|General linear model||The adjusted mean difference was based on Dut+Tam minus Tam.|||-2.2|-3.1|<.001
72539288|NCT02058368|144608233|SUPERIORITY|||||||0.77||||||P-value for Dut+Tam vs. Tam is based on a van Elteren test with stratification by country for Month 6|Van Elteren test|||||||0.77
72539289|NCT02058368|144608233|SUPERIORITY|||||||0.84||||||P-value for Dut+Tam vs. Tam is based on a van Elteren test with stratification by country for Month 12|Van Elteren test|||||||0.84
72539290|NCT02058368|144608233|SUPERIORITY|||||||0.98||||||P-value for Dut+Tam vs. Tam is based on a van Elteren test with stratification by country for Month 18|Van Elteren test|||||||0.98
72539291|NCT02058368|144608233|SUPERIORITY|||||||0.28||||||P-value for Dut+Tam vs. Tam is based on a van Elteren test with stratification by country for Month 24|Van Elteren test|||||||0.28
72539292|NCT01652872|144608254|OTHER||Treatment Difference|-0.27|||||TWO_SIDED|95.0|-6.39|5.85|||||Difference is fixed dose - titration.|||5.85|-6.39|
72539293|NCT01652872|144608254|OTHER||Risk Ratio (RR)|0.998|||||TWO_SIDED|95.0|0.776|1.285|||Cochran-Mantel-Haenszel|Stratified by RBC transfusion received within 12 months prior to randomization (yes/no) and site practice setting (nephrology/non-nephrology).|A risk ratio \< 1.0 indicates a lower event rate for the fixed dose group relative to Hb-based titration group.|||1.285|0.776|
72539294|NCT01652872|144608255|OTHER|Stratified by RBC transfusion received within 12 months prior to randomization (yes/no) and site practice setting (nephrology/non-nephrology) and accounting for participant exposure time.|Least Squares Mean (LSM) Ratio|1.28|||||TWO_SIDED|95.0|0.81|2.05|||Negative binomial regression model||Least Squares Mean (LSM) ratio is fixed dose relative to titration.|||2.05|0.81|
72539295|NCT01652872|144608256|OTHER||Hazard Ratio (HR)|1.01|||||TWO_SIDED|95.0|0.76|1.35|||Cox Proportional Hazard Model|Stratified by RBC transfusion received within 12 months prior to randomization (yes/no) and site practice setting (nephrology/non-nephrology).|Hazard ratio is fixed dose relative to titration.|||1.35|0.76|
72539296|NCT01652872|144608257|OTHER||Median of the difference|-0.34|||||TWO_SIDED|95.0|-0.46|-0.22|||Hodges-Lehmann estimate||Difference is fixed dose - titration.||The 2-sided 95% confidence intervals were obtained using a non-parametric Wilcoxon rank-sum statistic.|-0.22|-0.46|
72539297|NCT01652872|144608258|OTHER||Median of the difference|-22.1|||||TWO_SIDED|95.0|-26.1|-18.1|||Hodges-Lehmann estimate||Difference is fixed dose - titration.||The 2-sided 95% confidence intervals were obtained using a non-parametric Wilcoxon rank-sum statistic.|-18.1|-26.1|
72539298|NCT04529096|144608263|SUPERIORITY||Posterior Mean Difference|0.52|||||TWO_SIDED|95.0|-0.1|1.14|||Bayesian Mixed Model Analysis|||||1.14|-0.10|
72539299|NCT04529096|144608264|SUPERIORITY||Posterior Mean Difference|1.05|||||TWO_SIDED|95.0|-0.46|2.56|||Bayesian Mixed Model Analysis|||||2.56|-0.46|
72539300|NCT04529096|144608265|SUPERIORITY||Posterior Mean Difference|0.16|||||TWO_SIDED|95.0|-0.25|0.58|||Bayesian Mixed Model Analysis|||||0.58|-0.25|
72539301|NCT04529096|144608266|SUPERIORITY||Posterior Mean Difference|0.48|||||TWO_SIDED|95.0|-0.19|1.17|||Bayesian Mixed Model Analysis|||||1.17|-0.19|
72539302|NCT04529096|144608267|SUPERIORITY||Posterior Mean Difference|4.63|||||TWO_SIDED|95.0|-3.51|12.59|||Bayesian Mixed Model Analysis|||||12.59|-3.51|
72539303|NCT04529096|144608268|SUPERIORITY||Posterior Mean Difference|0.05|||||TWO_SIDED|95.0|-0.4|0.51|||Bayesian Mixed Model Analysis|||||0.51|-0.40|
72539304|NCT04529096|144608269|SUPERIORITY||Posterior Mean Difference|-15.18|||||TWO_SIDED|95.0|-206.43|175.8|||Bayesian Mixed Model Analysis|||||175.80|-206.43|
72539305|NCT04529096|144608270|SUPERIORITY||Posterior Mean Difference|-0.05|||||TWO_SIDED|95.0|-0.11|0.01|||Bayesian Mixed Model Analysis|||||0.01|-0.11|
72539306|NCT00929864|144608271|NON_INFERIORITY_OR_EQUIVALENCE|Analysis tested for non-inferiority. Abatacept will be considered non-inferior to adalimumab if the upper limit of the 95% two-sided CI of difference in ACR20 response rates between the adalimumab arm and the abatacept arm is smaller than or equal to 12%. Estimate and 95% confidence interval (CI) for difference based on minimum risk weights method with randomization stratification of screening Disease Activity Score-28 (DAS28) c-reactive protein (CRP).|Difference from adalimumab at Day 365|1.8|||||TWO_SIDED|95.0|-5.6|9.2|||minimum risk weights method|adjusted for randomization stratification of screening Disease Activity Score-28 (DAS28) c-reactive protein (CRP).||The null and alternative hypotheses are H0: T - C\<= δ vs. Ha:T - C \> δ, where T is the treatment effect of abatacept, C is the effect of active control (adalimumab),and δ is non-inferiority margin. Abatacept is defined as δ non-inferior to adalimumab when H0 is rejected. More specifically, if the lower bound of the 95% two-sided confidence interval for C-T is greater than δ,, then that Abatacept is δ non-inferior to adalimumab can be claimed.||9.2|-5.6|
72627384|NCT05136170|144783690|SUPERIORITY|||||||0.871||||||p-value corresponds to a non-parametric Mann-Whitney-Wilcoxon (Wilcoxon rank sum) test of the comparisons between Cenegermin and Vehicle in all patients.|Wilcoxon (Mann-Whitney)|||Herein analysis for QoL (Emotional Impact due to Dry Eye) - Week 12 was reported.||||0.871
72409690|NCT04116229|144327733|OTHER|"Alternative hypothesis: higher levels of leptin, a pro-inflammatory marker and satiety hormone, will relate to higher levels of putative neuroinflammation in white matter tracts as measured by DBSI restricted fraction after controlling for BMI.~Null hypothesis: Leptin levels will not be related to DBSI RF in white matter tracts after controlling for BMI."|Slope|0.15||||0.62|TWO_SIDED|||||a priori threshold: p \< 0.05|Regression, Linear|||"This is a pilot study with a small sample. Power to detect significant results is therefore low in the current study.~Analyses performed across normal-weight and obese groups."||||0.62
72409691|NCT04116229|144327733|OTHER|"Alternative hypothesis: higher levels of leptin, a pro-inflammatory marker and satiety hormone, will relate to higher levels of putative neuroinflammation in white matter tracts as measured by DBSI hindered fraction after controlling for BMI.~Null hypothesis: Leptin levels will not be related to DBSI HF in white matter tracts after controlling for BMI."|Slope|-0.07||||0.82|TWO_SIDED||||||Regression, Linear|||"This is a pilot study with a small sample. Power to detect significant results is therefore low in the current study.~Analyses performed across normal-weight and obese groups."||||0.82
72409692|NCT04116229|144327734|OTHER|"Alternative hypothesis: higher levels of ghrelin, an anti-inflammatory marker and hunger hormone, will relate to lower levels of putative neuroinflammation in white matter tracts as measured by DBSI restricted fraction after controlling for BMI.~Null hypothesis: Ghrelin levels will not be related to DBSI RF in white matter tracts after controlling for BMI."|Slope|0.19||||0.53|TWO_SIDED|||||a priori threshold: p \< 0.05|Regression, Linear|||"This is a pilot study with a small sample. Power to detect significant results is therefore low in the current study.~Analyses performed across normal-weight and obese groups."||||0.53
72409693|NCT04116229|144327734|OTHER|"Alternative hypothesis: higher levels of ghrelin, an anti-inflammatory marker and hunger hormone, will relate to lower levels of putative neuroinflammation in white matter tracts as measured by DBSI hindered fraction after controlling for BMI.~Null hypothesis: Ghrelin levels will not be related to DBSI HF in white matter tracts after controlling for BMI."|Slope|-0.12||||0.71|TWO_SIDED|||||a priori threshold: p \< 0.05|Regression, Linear|||"This is a pilot study with a small sample. Power to detect significant results is therefore low in the current study.~Analyses performed across normal-weight and obese groups."||||0.71
72409694|NCT04116229|144327735|OTHER|"Alternative hypothesis: greater HOMA-IR, where higher HOMA-IR indicates greater insulin resistance, will relate to higher levels of putative neuroinflammation in white matter tracts as measured by DBSI restricted fraction after controlling for BMI.~Null hypothesis: HOMA-IR levels will not be related to DBSI RF in white matter tracts after controlling for BMI."|Slope|-0.19||||0.53|TWO_SIDED|||||a priori threshold: p \< 0.05|Regression, Linear|||"This is a pilot study with a small sample. Power to detect significant results is therefore low in the current study.~Analyses performed across normal-weight and obese groups."||||0.53
72409695|NCT04116229|144327735|OTHER|"Alternative hypothesis: greater HOMA-IR, where higher HOMA-IR indicates greater insulin resistance, will relate to higher levels of putative neuroinflammation in white matter tracts as measured by DBSI hindered fraction after controlling for BMI.~Null hypothesis: HOMA-IR levels will not be related to DBSI HF in white matter tracts after controlling for BMI."|Slope|-0.21||||0.5|TWO_SIDED||||||Regression, Linear|||"This is a pilot study with a small sample. Power to detect significant results is therefore low in the current study.~Analyses performed across normal-weight and obese groups."||||0.5
72409696|NCT04116229|144327736|OTHER|"Alternative hypothesis: higher levels of IL-10, an anti-inflammatory marker, will relate to lower levels of putative neuroinflammation in white matter tracts as measured by DBSI restricted fraction after controlling for BMI.~Null hypothesis: IL-10 levels will not be related to DBSI RF in white matter tracts after controlling for BMI."|Slope|0.5||||0.09|TWO_SIDED|||||a priori threshold: p \< 0.05|Regression, Linear|||This is a pilot study with a small sample. Power to detect significant results is therefore low in the current study. Analyses performed across normal-weight and obese groups.||||0.09
72409697|NCT04116229|144327736|OTHER|"Alternative hypothesis: higher levels of IL-10, an anti-inflammatory marker, will relate to lower levels of putative neuroinflammation in white matter tracts as measured by DBSI hindered fraction after controlling for BMI.~Null hypothesis: IL-10 levels will not be related to DBSI HF in white matter tracts after controlling for BMI."|Slope|-0.2||||0.45|TWO_SIDED|||||a priori threshold: p \< 0.05|Regression, Linear|||This is a pilot study with a small sample. Power to detect significant results is therefore low in the current study. Analyses performed across normal-weight and obese groups.||||0.45
72539307|NCT00929864|144608272|SUPERIORITY_OR_OTHER||Difference in proportions|-5.37||||0.006|TWO_SIDED|95.0|-9.13|-1.62|||Chi-squared|||Analysis is p-value of difference in proportions. n=number of participants with event, N=number of participants at risk. Proportion = n/N. In order to maintain the overall type I error rate of 0.05 for testing both the primary non-inferiority hypothesis and the key secondary local injection site reaction (LISR) hypothesis, the LISR hypothesis was tested at the 5% significance level only after the primary non-inferiority hypothesis is established at the 5% level.||-1.62|-9.13|0.006
72539308|NCT00929864|144608273|SUPERIORITY_OR_OTHER||Difference from adalimumab|-4.13|||||TWO_SIDED|95.0|-6.55|-1.72||||||Analysis of incidence rate at 24 months. Point estimate and 95% CI. Poisson distribution was used to construct the 95% CIs.||-1.72|-6.55|
72539309|NCT00929864|144608274|SUPERIORITY_OR_OTHER||Difference from adalimumab at Day 365|-1.3|||||TWO_SIDED|95.0|-6.5|3.9|||minimum risk weights method|Adjusted for randomization stratification of screening Disease Activity Score-28 (DAS28) c-reactive protein (CRP).||This analysis is for Day 365.||3.9|-6.5|
72539310|NCT00929864|144608274|SUPERIORITY_OR_OTHER||Difference from adalimumab at Day 729|0.9|||||TWO_SIDED|95.0|-5.5|7.3|||minimum risk weights method|Adjusted for randomization stratification of screening Disease Activity Score-28 (DAS28) c-reactive protein (CRP).||This analysis is for Day 729.||7.3|-5.5|
72539311|NCT00929864|144608275|SUPERIORITY_OR_OTHER||Difference from adalimumab|0.8|||||TWO_SIDED|95.0|-4.51|6.11||||||Analysis for incidence rate of SAE at 12 months. Point estimate and 95% CI for treatment difference. Poisson distribution was used to construct the 95% CIs.||6.11|-4.51|
72539312|NCT00929864|144608275|SUPERIORITY_OR_OTHER||Difference from adalimumab|-0.67|||||TWO_SIDED|95.0|-3.27|1.94||||||Analysis for incidence rate of Serious Infections and Infestations at 12 months. Point estimate and 95% CI for treatment difference. Poisson distribution was used to construct the 95% CIs.||1.94|-3.27|
72539313|NCT00929864|144608275|SUPERIORITY_OR_OTHER||Difference from adalimumab|0.0|||||TWO_SIDED|95.0|-0.92|0.91||||||Analysis for incidence rate of Opportunistic Infections at 12 months. Point estimate and 95% CI for treatment difference. Poisson distribution was used to construct the 95% CIs.||0.91|-0.92|
72539314|NCT00929864|144608275|SUPERIORITY_OR_OTHER||Difference from adalimumab|-5.32|||||TWO_SIDED|95.0|-12.06|1.41||||||Analysis for incidence rate of discontinuation for any cause at 12 months. Point estimate and 95% CI for treatment difference. Poisson distribution was used to construct the 95% CIs.||1.41|-12.06|
72539315|NCT00929864|144608276|SUPERIORITY_OR_OTHER||Difference from adalimumab|-1.91|||||TWO_SIDED|95.0|-5.43|1.61||||||Analysis for incidence rate of SAE at 24 months. Point estimate and 95% CI for treatment difference. Poisson distribution was used to construct the 95% CIs.||1.61|-5.43|
72539316|NCT00929864|144608276|SUPERIORITY_OR_OTHER||Difference from adalimumab|-1.24|||||TWO_SIDED|95.0|-3.12|0.63||||||Analysis for incidence rate of Serious infections and infestations Adverse Events at 24 months. Point estimate and 95% CI for treatment difference. Poisson distribution was used to construct the 95% CIs.||0.63|-3.12|
72539317|NCT00929864|144608276|SUPERIORITY_OR_OTHER||Difference from adalimumab|-0.52|||||TWO_SIDED|95.0|-1.39|0.36|||minimum risk weights method|||Analysis for incidence rate of opportunistic infections at 24 months. Point estimate and 95% CI for treatment difference. Poisson distribution was used to construct the 95% CIs.||0.36|-1.39|
72539318|NCT00929864|144608276|SUPERIORITY_OR_OTHER||Difference from adalimumab|-3.1|||||TWO_SIDED|95.0|-7.13|0.92||||||Analysis for incidence rate of discontinuations (all cause) at 24 months. Point estimate and 95% CI for treatment difference. Poisson distribution was used to construct the 95% CIs.||0.92|-7.13|
72539319|NCT00929864|144608277|SUPERIORITY_OR_OTHER||Difference from adalimumab|-8.1|||||TWO_SIDED|95.0|-13.9|-2.2||||||Analysis for ANA at Day 365. Point estimate and 95% CI for treatment difference.||-2.2|-13.9|
72539320|NCT00929864|144608277|SUPERIORITY_OR_OTHER||Difference from adalimumab|-8.4|||||TWO_SIDED|95.0|-15.3|-1.5||||||Analysis for ANA at Day 729. Point estimate and 95% CI for treatment difference||-1.5|-15.3|
72539321|NCT00929864|144608277|SUPERIORITY_OR_OTHER||Difference from adalimumab|-9.6|||||TWO_SIDED|95.0|-13.4|-5.7||||||Analysis for dsDNA at Day 365. Point estimate and 95% CI for treatment difference.||-5.7|-13.4|
72539322|NCT00929864|144608277|SUPERIORITY_OR_OTHER||Difference from adalimumab|-12.2|||||TWO_SIDED|95.0|-16.9|-7.6||||||Analysis for dsDNA at Day 729. Point estimate and 95% CI for treatment difference.||-7.6|-16.9|
72539323|NCT03985293|144608304|SUPERIORITY||Difference in LS Mean|-0.47||||0.0071|TWO_SIDED|90.0|-0.76|-0.18|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-0.18|-0.76|0.0071
72539324|NCT03985293|144608304|SUPERIORITY||Difference in LS Mean|-0.9|||<|0.0001|TWO_SIDED|90.0|-1.18|-0.62|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-0.62|-1.18|<.0001
72539325|NCT03985293|144608304|SUPERIORITY||Difference in LS Mean|-1.01|||<|0.0001|TWO_SIDED|90.0|-1.3|-0.73|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-0.73|-1.30|<.0001
72539326|NCT03985293|144608304|SUPERIORITY||Difference in LS Mean|-0.94|||<|0.0001|TWO_SIDED|90.0|-1.24|-0.65|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-0.65|-1.24|<.0001
72539327|NCT03985293|144608304|SUPERIORITY||Difference in LS Mean|-1.16|||<|0.0001|TWO_SIDED|90.0|-1.47|-0.86|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-0.86|-1.47|<.0001
72539328|NCT03985293|144608305|SUPERIORITY||Odds Ratio (OR)|5.11|||||TWO_SIDED|90.0|1.84|14.18|||Regression, Logistic||The Odds ratio model included multiple imputation. PF-06882961 = Test Placebo = Reference|||14.18|1.84|
72539329|NCT03985293|144608305|SUPERIORITY||Odds Ratio (OR)|16.85|||||TWO_SIDED|90.0|6.18|45.93|||Regression, Logistic||The Odds ratio model included multiple imputation. PF-06882961 = Test Placebo = Reference|||45.93|6.18|
72539330|NCT03985293|144608305|SUPERIORITY||Odds Ratio (OR)|18.79|||||TWO_SIDED|90.0|7.03|50.21|||Regression, Logistic||The Odds ratio model included multiple imputation. PF-06882961 = Test Placebo = Reference|||50.21|7.03|
72539331|NCT03985293|144608305|SUPERIORITY||Odds Ratio (OR)|23.97|||||TWO_SIDED|90.0|8.66|66.39|||Regression, Logistic||The Odds ratio model included multiple imputation. PF-06882961 = Test Placebo = Reference|||66.39|8.66|
72539332|NCT03985293|144608305|SUPERIORITY||Odds Ratio (OR)|24.46|||||TWO_SIDED|90.0|8.72|68.57|||Regression, Logistic||The Odds ratio model included multiple imputation. PF-06882961 = Test Placebo = Reference|||68.57|8.72|
72539333|NCT03985293|144608306|SUPERIORITY||Difference in LS Mean|-0.09||||0.1578|TWO_SIDED|90.0|-0.19|0.01|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||0.01|-0.19|0.1578
72539334|NCT03985293|144608306|SUPERIORITY||Difference in LS Mean|-0.22||||0.0003|TWO_SIDED|90.0|-0.32|-0.12|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-0.12|-0.32|0.0003
72539335|NCT03985293|144608306|SUPERIORITY||Difference in LS Mean|-0.2||||0.0013|TWO_SIDED|90.0|-0.3|-0.1|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-0.10|-0.30|0.0013
72539336|NCT03985293|144608306|SUPERIORITY||Difference in LS Mean|-0.24||||0.0001|TWO_SIDED|90.0|-0.34|-0.14|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-0.14|-0.34|0.0001
72539337|NCT03985293|144608306|SUPERIORITY||Difference in LS Mean|-0.26|||<|0.0001|TWO_SIDED|90.0|-0.36|-0.16|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-0.16|-0.36|<.0001
72539338|NCT03985293|144608307|SUPERIORITY||Difference in LS Mean|-0.3||||0.0013|TWO_SIDED|90.0|-0.46|-0.15|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-0.15|-0.46|0.0013
72539339|NCT03985293|144608307|SUPERIORITY||Difference in LS Mean|-0.43|||<|0.0001|TWO_SIDED|90.0|-0.58|-0.28|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-0.28|-0.58|<.0001
72539340|NCT03985293|144608307|SUPERIORITY||Difference in LS Mean|-0.55|||<|0.0001|TWO_SIDED|90.0|-0.7|-0.4|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-0.40|-0.70|<.0001
72539341|NCT03985293|144608307|SUPERIORITY||Difference in LS Mean|-0.5|||<|0.0001|TWO_SIDED|90.0|-0.66|-0.35|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-0.35|-0.66|<.0001
72539342|NCT03985293|144608307|SUPERIORITY||Difference in LS Mean|-0.56|||<|0.0001|TWO_SIDED|90.0|-0.71|-0.41|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-0.41|-0.71|<.0001
72539343|NCT03985293|144608308|SUPERIORITY||Difference in LS Mean|-0.4||||0.0004|TWO_SIDED|90.0|-0.59|-0.22|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-0.22|-0.59|0.0004
72539344|NCT03985293|144608308|SUPERIORITY||Difference in LS Mean|-0.64|||<|0.0001|TWO_SIDED|90.0|-0.81|-0.46|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-0.46|-0.81|<.0001
72539345|NCT03985293|144608308|SUPERIORITY||Difference in LS Mean|-0.77|||<|0.0001|TWO_SIDED|90.0|-0.95|-0.59|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-0.59|-0.95|<.0001
72539346|NCT03985293|144608308|SUPERIORITY||Difference in LS Mean|-0.72|||<|0.0001|TWO_SIDED|90.0|-0.91|-0.53|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-0.53|-0.91|<.0001
72539347|NCT03985293|144608308|SUPERIORITY||Difference in LS Mean|-0.77|||<|0.0001|TWO_SIDED|90.0|-0.95|-0.59|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-0.59|-0.95|<.0001
72539348|NCT03985293|144608309|SUPERIORITY||Difference in LS Mean|-0.37||||0.0054|TWO_SIDED|90.0|-0.59|-0.15|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-0.15|-0.59|0.0054
72539349|NCT03985293|144608309|SUPERIORITY||Difference in LS Mean|-0.65|||<|0.0001|TWO_SIDED|90.0|-0.86|-0.44|||Mixed Models Analysis||PF-06882961 = Test Placebo = Reference|||-0.44|-0.86|<.0001
72539350|NCT03985293|144608309|SUPERIORITY||Difference in LS Mean|-0.84|||<|0.0001|TWO_SIDED|90.0|-1.06|-0.63|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-0.63|-1.06|<.0001
72539351|NCT03985293|144608309|SUPERIORITY||Difference in LS Mean|-0.8|||<|0.0001|TWO_SIDED|90.0|-1.02|-0.57|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-0.57|-1.02|<.0001
72539352|NCT03985293|144608309|SUPERIORITY||Difference in LS Mean|-0.89|||<|0.0001|TWO_SIDED|90.0|-1.11|-0.67|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-0.67|-1.11|<.0001
72539353|NCT03985293|144608310|SUPERIORITY||Difference in LS Mean|-0.44||||0.0061|TWO_SIDED|90.0|-0.71|-0.18|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-0.18|-0.71|0.0061
72539354|NCT03985293|144608310|SUPERIORITY||Difference in LS Mean|-0.79|||<|0.0001|TWO_SIDED|90.0|-1.05|-0.54|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-0.54|-1.05|<.0001
72539355|NCT03985293|144608310|SUPERIORITY||Difference in LS Mean|-0.98|||<|0.0001|TWO_SIDED|90.0|-1.24|-0.72|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-0.72|-1.24|<.0001
72539356|NCT03985293|144608310|SUPERIORITY||Difference in LS Mean|-0.83|||<|0.0001|TWO_SIDED|90.0|-1.1|-0.56|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-0.56|-1.10|<.0001
72539357|NCT03985293|144608310|SUPERIORITY||Difference in LS Mean|-1.03|||<|0.0001|TWO_SIDED|90.0|-1.3|-0.75|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-0.75|-1.30|<.0001
72539358|NCT03985293|144608311|SUPERIORITY||Difference in LS Mean|-17.13||||0.0014|TWO_SIDED|90.0|-25.94|-8.33|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-8.33|-25.94|0.0014
72539359|NCT03985293|144608311|SUPERIORITY||Difference in LS Mean|-16.38||||0.0021|TWO_SIDED|90.0|-25.08|-7.67|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|Difference in LS Mean|||-7.67|-25.08|0.0021
72539360|NCT03985293|144608311|SUPERIORITY||Difference in LS Mean|-22.2|||<|0.0001|TWO_SIDED|90.0|-30.88|-13.53|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-13.53|-30.88|<.0001
72539361|NCT03985293|144608311|SUPERIORITY||Difference in LS Mean|-18.59||||0.0006|TWO_SIDED|90.0|-27.43|-9.76|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-9.76|-27.43|0.0006
72539362|NCT03985293|144608311|SUPERIORITY||Difference in LS Mean|-25.33|||<|0.0001|TWO_SIDED|90.0|-34.0|-16.67|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-16.67|-34.00|<.0001
72539363|NCT03985293|144608312|SUPERIORITY||Difference in LS Mean|-11.79||||0.0468|TWO_SIDED|90.0|-21.55|-2.04|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-2.04|-21.55|0.0468
72539364|NCT03985293|144608312|SUPERIORITY||Difference in LS Mean|-18.68||||0.0012|TWO_SIDED|90.0|-28.12|-9.25|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-9.25|-28.12|0.0012
72539365|NCT03985293|144608312|SUPERIORITY||Difference in LS Mean|-27.44|||<|0.0001|TWO_SIDED|90.0|-37.03|-17.85|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-17.85|-37.03|<.0001
72539366|NCT03985293|144608312|SUPERIORITY||Difference in LS Mean|-27.36|||<|0.0001|TWO_SIDED|90.0|-37.22|-17.51|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-17.51|-37.22|<.0001
72539367|NCT03985293|144608312|SUPERIORITY||Difference in LS Mean|-28.09|||<|0.0001|TWO_SIDED|90.0|-37.72|-18.45|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-18.45|-37.72|<.0001
72539368|NCT03985293|144608313|SUPERIORITY||Difference in LS Mean|-15.9||||0.0091|TWO_SIDED|90.0|-25.9|-5.9|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-5.90|-25.90|0.0091
72539369|NCT03985293|144608313|SUPERIORITY||Difference in LS Mean|-25.53|||<|0.0001|TWO_SIDED|90.0|-35.18|-15.89|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-15.89|-35.18|<.0001
72539370|NCT03985293|144608313|SUPERIORITY||Difference in LS Mean|-30.01|||<|0.0001|TWO_SIDED|90.0|-39.8|-20.21|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-20.21|-39.80|<.0001
72539371|NCT03985293|144608313|SUPERIORITY||Difference in LS Mean|-27.48|||<|0.0001|TWO_SIDED|90.0|-37.63|-17.33|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-17.33|-37.63|<.0001
72539372|NCT03985293|144608313|SUPERIORITY||Difference in LS Mean|-31.77|||<|0.0001|TWO_SIDED|90.0|-41.77|-21.78|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-21.78|-41.77|<.0001
72539373|NCT03985293|144608314|SUPERIORITY||Difference in LS Mean|-3.63||||0.5449|TWO_SIDED|90.0|-13.51|6.25|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||6.25|-13.51|0.5449
72539374|NCT03985293|144608314|SUPERIORITY||Difference in LS Mean|-17.12||||0.0031|TWO_SIDED|90.0|-26.62|-7.63|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-7.63|-26.62|0.0031
72539375|NCT03985293|144608314|SUPERIORITY||Difference in LS Mean|-20.64||||0.0005|TWO_SIDED|90.0|-30.31|-10.96|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-10.96|-30.31|0.0005
72539376|NCT03985293|144608314|SUPERIORITY||Difference in LS Mean|-24.12|||<|0.0001|TWO_SIDED|90.0|-34.2|-14.04|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-14.04|-34.20|<.0001
72409698|NCT04116229|144327737|OTHER|"Alternative hypothesis: higher levels of adiponectin, an anti-inflammatory marker, will relate to lower levels of putative neuroinflammation in white matter tracts as measured by DBSI restricted fraction after controlling for BMI.~Null hypothesis: Adiponectin levels will not be related to DBSI RF in white matter tracts after controlling for BMI."|Slope|0.38||||0.19|TWO_SIDED|||||a priori threshold: p \< 0.05|Regression, Linear|||This is a pilot study with a small sample. Power to detect significant results is therefore low in the current study. Analyses performed across normal-weight and obese groups.||||0.19
72539377|NCT03985293|144608314|SUPERIORITY||Difference in LS Mean|-25.21|||<|0.0001|TWO_SIDED|90.0|-35.44|-14.97|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-14.97|-35.44|<.0001
72539378|NCT03985293|144608315|SUPERIORITY||Difference in LS Mean|-7.7||||0.294|TWO_SIDED|90.0|-19.78|4.38|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||4.38|-19.78|0.2940
72539379|NCT03985293|144608315|SUPERIORITY||Difference in LS Mean|-23.77||||0.0008|TWO_SIDED|90.0|-35.37|-12.17|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-12.17|-35.37|0.0008
72539380|NCT03985293|144608315|SUPERIORITY||Difference in LS Mean|-33.23|||<|0.0001|TWO_SIDED|90.0|-45.05|-21.4|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-21.40|-45.05|<.0001
72539381|NCT03985293|144608315|SUPERIORITY||Difference in LS Mean|-31.66|||<|0.0001|TWO_SIDED|90.0|-44.14|-19.19|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-19.19|-44.14|<.0001
72539382|NCT03985293|144608315|SUPERIORITY||Difference in LS Mean|-33.59|||<|0.0001|TWO_SIDED|90.0|-46.67|-20.51|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-20.51|-46.67|<.0001
72539383|NCT03985293|144608316|SUPERIORITY||Difference in LS Mean|-14.12||||0.0464|TWO_SIDED|90.0|-25.77|-2.47|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-2.47|-25.77|0.0464
72539384|NCT03985293|144608316|SUPERIORITY||Difference in LS Mean|-25.84||||0.0002|TWO_SIDED|90.0|-37.05|-14.62|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-14.62|-37.05|0.0002
72539385|NCT03985293|144608316|SUPERIORITY||Difference in LS Mean|-31.78|||<|0.0001|TWO_SIDED|90.0|-43.2|-20.35|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-20.35|-43.20|<.0001
72539386|NCT03985293|144608316|SUPERIORITY||Difference in LS Mean|-27.02||||0.0002|TWO_SIDED|90.0|-39.03|-15.01|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-15.01|-39.03|0.0002
72539387|NCT03985293|144608316|SUPERIORITY||Difference in LS Mean|-33.24|||<|0.0001|TWO_SIDED|90.0|-45.63|-20.84|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-20.84|-45.63|<.0001
72539388|NCT03985293|144608317|SUPERIORITY||Difference in LS Mean|0.06||||0.8011|TWO_SIDED|90.0|-0.33|0.44|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||0.44|-0.33|0.8011
72539389|NCT03985293|144608317|SUPERIORITY||Difference in LS Mean|0.02||||0.9149|TWO_SIDED|90.0|-0.35|0.4|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||0.40|-0.35|0.9149
72539390|NCT03985293|144608317|SUPERIORITY||Difference in LS Mean|-0.08||||0.7216|TWO_SIDED|90.0|-0.46|0.3|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||0.30|-0.46|0.7216
72539391|NCT03985293|144608317|SUPERIORITY||Difference in LS Mean|-0.42||||0.0758|TWO_SIDED|90.0|-0.8|-0.03|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-0.03|-0.80|0.0758
72539392|NCT03985293|144608317|SUPERIORITY||Difference in LS Mean|-0.4||||0.086|TWO_SIDED|90.0|-0.77|-0.02|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-0.02|-0.77|0.0860
72539393|NCT03985293|144608318|SUPERIORITY||Difference in LS Mean|-0.08||||0.7898|TWO_SIDED|90.0|-0.59|0.42|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||0.42|-0.59|0.7898
72539394|NCT03985293|144608318|SUPERIORITY||Difference in LS Mean|0.16||||0.5829|TWO_SIDED|90.0|-0.33|0.66|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||0.66|-0.33|0.5829
72539395|NCT03985293|144608318|SUPERIORITY||Difference in LS Mean|-0.52||||0.0827|TWO_SIDED|90.0|-1.02|-0.03|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-0.03|-1.02|0.0827
72539396|NCT03985293|144608318|SUPERIORITY||Difference in LS Mean|-0.8||||0.0101|TWO_SIDED|90.0|-1.31|-0.29|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-0.29|-1.31|0.0101
72539397|NCT03985293|144608318|SUPERIORITY||Difference in LS Mean|-1.09||||0.0004|TWO_SIDED|90.0|-1.59|-0.59|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-0.59|-1.59|0.0004
72539398|NCT03985293|144608319|SUPERIORITY||Difference in LS Mean|-0.1||||0.7985|TWO_SIDED|90.0|-0.75|0.55|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||0.55|-0.75|0.7985
72539399|NCT03985293|144608319|SUPERIORITY||Difference in LS Mean|-0.23||||0.5484|TWO_SIDED|90.0|-0.86|0.4|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||0.40|-0.86|0.5484
72539400|NCT03985293|144608319|SUPERIORITY||Difference in LS Mean|-0.75||||0.0541|TWO_SIDED|90.0|-1.38|-0.11|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-0.11|-1.38|0.0541
72539401|NCT03985293|144608319|SUPERIORITY||Difference in LS Mean|-1.6|||<|0.0001|TWO_SIDED|90.0|-2.26|-0.95|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-0.95|-2.26|<.0001
72539402|NCT03985293|144608319|SUPERIORITY||Difference in LS Mean|-2.25|||<|0.0001|TWO_SIDED|90.0|-2.9|-1.6|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-1.60|-2.90|<.0001
72539403|NCT03985293|144608320|SUPERIORITY||Difference in LS Mean|0.31||||0.4692|TWO_SIDED|90.0|-0.4|1.03|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||1.03|-0.40|0.4692
72539404|NCT03985293|144608320|SUPERIORITY||Difference in LS Mean|0.09||||0.8274|TWO_SIDED|90.0|-0.6|0.78|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||0.78|-0.60|0.8274
72539405|NCT03985293|144608320|SUPERIORITY||Difference in LS Mean|-0.72||||0.0887|TWO_SIDED|90.0|-1.42|-0.02|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-0.02|-1.42|0.0887
72539406|NCT03985293|144608320|SUPERIORITY||Difference in LS Mean|-1.61||||0.0003|TWO_SIDED|90.0|-2.33|-0.88|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-0.88|-2.33|0.0003
72539407|NCT03985293|144608320|SUPERIORITY||Difference in LS Mean|-2.95|||<|0.0001|TWO_SIDED|90.0|-3.67|-2.22|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-2.22|-3.67|<.0001
72575298|NCT01338870|144676545|SUPERIORITY_OR_OTHER||LS mean difference|-19.57|STANDARD_ERROR_OF_MEAN|5.707||0.0006|TWO_SIDED|95.0|-30.77|-8.36|||Mixed Models Analysis|||Week 4: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||-8.36|-30.77|0.0006
72575299|NCT01338870|144676545|SUPERIORITY_OR_OTHER||LS mean difference|-19.08|STANDARD_ERROR_OF_MEAN|5.696||0.0008|TWO_SIDED|95.0|-30.26|-7.9|||Mixed Models Analysis|||Week 4: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||-7.90|-30.26|0.0008
72575300|NCT01338870|144676545|SUPERIORITY_OR_OTHER||LS mean difference|6.99|STANDARD_ERROR_OF_MEAN|6.055||0.2488|TWO_SIDED|95.0|-4.9|18.87|||Mixed Models Analysis|||Week 8: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||18.87|-4.90|0.2488
72575301|NCT01338870|144676545|SUPERIORITY_OR_OTHER||LS mean difference|-7.56|STANDARD_ERROR_OF_MEAN|6.004||0.2084|TWO_SIDED|95.0|-19.34|4.23|||Mixed Models Analysis|||Week 8: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||4.23|-19.34|0.2084
72575302|NCT01338870|144676545|SUPERIORITY_OR_OTHER||LS mean difference|0.71|STANDARD_ERROR_OF_MEAN|5.971||0.9053|TWO_SIDED|95.0|-11.01|12.43|||Mixed Models Analysis|||Week 8: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||12.43|-11.01|0.9053
72575303|NCT01338870|144676545|SUPERIORITY_OR_OTHER||LS mean difference|-15.3|STANDARD_ERROR_OF_MEAN|5.853||0.0091|TWO_SIDED|95.0|-26.79|-3.81|||Mixed Models Analysis|||Week 8: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||-3.81|-26.79|0.0091
72575304|NCT01338870|144676545|SUPERIORITY_OR_OTHER||LS mean difference|-18.62|STANDARD_ERROR_OF_MEAN|5.875||0.0016|TWO_SIDED|95.0|-30.15|-7.09|||Mixed Models Analysis|||Week 8: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||-7.09|-30.15|0.0016
72575305|NCT01338870|144676545|SUPERIORITY_OR_OTHER||LS mean difference|6.5|STANDARD_ERROR_OF_MEAN|6.217||0.2963|TWO_SIDED|95.0|-5.71|18.7|||Mixed Models Analysis|||Week 12: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||18.70|-5.71|0.2963
72575306|NCT01338870|144676545|SUPERIORITY_OR_OTHER||LS mean difference|-9.71|STANDARD_ERROR_OF_MEAN|6.17||0.1159|TWO_SIDED|95.0|-21.82|2.4|||Mixed Models Analysis|||Week 12: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||2.40|-21.82|0.1159
72575307|NCT01338870|144676545|SUPERIORITY_OR_OTHER||LS mean difference|4.7|STANDARD_ERROR_OF_MEAN|6.103||0.4413|TWO_SIDED|95.0|-7.28|16.68|||Mixed Models Analysis|||Week 12: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||16.68|-7.28|0.4413
72539408|NCT03985293|144608321|SUPERIORITY||Difference in LS Mean|0.15||||0.7758|TWO_SIDED|90.0|-0.7|0.99|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||0.99|-0.70|0.7758
72539409|NCT03985293|144608321|SUPERIORITY||Difference in LS Mean|0.23||||0.6367|TWO_SIDED|90.0|-0.58|1.05|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||1.05|-0.58|0.6367
72575308|NCT01338870|144676545|SUPERIORITY_OR_OTHER||LS mean difference|-15.3|STANDARD_ERROR_OF_MEAN|5.918||0.0099|TWO_SIDED|95.0|-26.91|-3.68|||Mixed Models Analysis|||Week 12: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||-3.68|-26.91|0.0099
72575309|NCT01338870|144676545|SUPERIORITY_OR_OTHER||LS mean difference|-14.95|STANDARD_ERROR_OF_MEAN|5.981||0.0126|TWO_SIDED|95.0|-26.69|-3.21|||Mixed Models Analysis|||Week 12: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||-3.21|-26.69|0.0126
72575310|NCT01338870|144676546|SUPERIORITY_OR_OTHER||LS mean difference|-0.05|STANDARD_ERROR_OF_MEAN|0.058||0.1797|TWO_SIDED|80.0|-0.13|0.02|||Mixed Models Analysis|||Week 1: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction, baseline-by-treatment interaction, baseline-by-treatment-by-time interaction as the covariates, time was repeated for participant.||0.02|-0.13|0.1797
72539410|NCT03985293|144608321|SUPERIORITY||Difference in LS Mean|-0.81||||0.1082|TWO_SIDED|90.0|-1.63|0.02|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||0.02|-1.63|0.1082
72539411|NCT03985293|144608321|SUPERIORITY||Difference in LS Mean|-2.28|||<|0.0001|TWO_SIDED|90.0|-3.14|-1.42|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-1.42|-3.14|<.0001
72539412|NCT03985293|144608321|SUPERIORITY||Difference in LS Mean|-3.57|||<|0.0001|TWO_SIDED|90.0|-4.44|-2.7|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-2.70|-4.44|<.0001
72539413|NCT03985293|144608322|SUPERIORITY||Difference in LS Mean|0.45||||0.4325|TWO_SIDED|90.0|-0.5|1.41|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||1.41|-0.50|0.4325
72539414|NCT03985293|144608322|SUPERIORITY||Difference in LS Mean|0.38||||0.4978|TWO_SIDED|90.0|-0.54|1.3|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||1.30|-0.54|0.4978
72539415|NCT03985293|144608322|SUPERIORITY||Difference in LS Mean|-0.73||||0.197|TWO_SIDED|90.0|-1.66|0.2|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||0.20|-1.66|0.1970
72539416|NCT03985293|144608322|SUPERIORITY||Difference in LS Mean|-2.04||||0.0006|TWO_SIDED|90.0|-3.01|-1.07|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-1.07|-3.01|0.0006
72539417|NCT03985293|144608322|SUPERIORITY||Difference in LS Mean|-4.17|||<|0.0001|TWO_SIDED|90.0|-5.15|-3.18|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-3.18|-5.15|<.0001
72539418|NCT01345058|144608336|SUPERIORITY||Hazard Ratio (HR)|0.76||||0.49|TWO_SIDED|95.0|0.35|1.65|||Chi-squared||Hazard ratio for seizure occurrence for polytherapy relative to monotherapy.|||1.65|0.35|0.49
72539419|NCT01892020|144608352|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.12|STANDARD_ERROR_OF_MEAN|0.27|<|0.001||95.0|-1.66|-0.58||The 2-h PPG increment was analyzed using a normal linear mixed model with period and treatment as fixed effects and subject as a random effect.|Mixed Models Analysis|||Let D be the treatment difference (BIAsp 50 BID + metformin minus BHI 50 BID + metformin) of 2-h PPG increment after a 4-week treatment. The null hypothesis was D = 0 mmol/L. The alternative hypothesis was D ≠ 0 mmol/L. Sample size was determined using a two-sided one sample t-test at a = 0.05 under the assumption of 0.8 mmol/L mean treatment different and 80% power.||-0.58|-1.66|< 0.001
72627385|NCT05136170|144783690|SUPERIORITY|||||||0.85||||||p-value corresponds to a two sample (independent group) t-test of the comparisons between Cenegermin and Vehicle in all patients.|t-test, 2 sided|||Herein analysis for QoL (Emotional Impact due to Dry Eye) - Week 16 was reported.||||0.85
72539420|NCT04876482|144608375|OTHER|The Overall Number of Participants Analyzed do not appear to be equal, so we used linear regrssion to compare the mean difference among three groups.|Mean Difference (Final Values)|-10.76|||<|0.05|TWO_SIDED||||||Regression, Linear|||"We hypothesized that the improvements in the AHI would be higher in patients who underwent TORS combined with OPR than in those who underwent only TORS and those who received conservative treatment (controls).~."||||<0.05
72539421|NCT04876482|144608376|OTHER|The Overall Number of Participants Analyzed do not appear to be equal, so we used linear regrssion to compare the mean difference among three groups.|Mean Difference (Final Values)|2.05|||<|0.05|TWO_SIDED||||||Regression, Linear|||We hypothesized that the improvements in the upper airway volume would be higher in patients who underwent TORS combined with OPR than in those who underwent only TORS and those who received conservative treatment (controls).||||<0.05
72539422|NCT04876482|144608377|OTHER|The Overall Number of Participants Analyzed do not appear to be equal, so we used linear regrssion to compare the mean difference among three groups.|Mean Difference (Final Values)|0.275|||<|0.05|TWO_SIDED||||||Regression, Linear|||We hypothesized that the improvements in the minimal area on the tip of epiglottis would be more in patients who underwent TORS combined with OPR than in those who underwent only TORS and those who received conservative treatment (controls)||||<0.05
72539423|NCT04876482|144608378|OTHER|The Overall Number of Participants Analyzed do not appear to be equal, so we used linear regrssion to compare the mean difference among three groups.|Mean Difference (Final Values)|-0.14|||<|0.05|TWO_SIDED||||||Regression, Linear|||We hypothesized that the improvements in the anteror to posterior distance on the tip of epiglottis would be more in patients who underwent TORS combined with OPR than in those who underwent only TORS and those who received conservative treatment (controls).||||<0.05
72539424|NCT04876482|144608379|OTHER|The Overall Number of Participants Analyzed do not appear to be equal, so we used linear regrssion to compare the mean difference among three groups.|Mean Difference (Final Values)|0.01|||<|0.05|TWO_SIDED||||||Regression, Linear|||We hypothesized that the improvements in the lateral distance on the tip of epiglottis would be more in patients who underwent TORS combined with OPR than in those who underwent only TORS and those who received conservative treatment (controls).||||<0.05
72539425|NCT04876482|144608380|OTHER|Baseline characteristics among the study groups were compared using Fisher exact test for categorical variables. McNemar chi-square test used for within-group analysis.|Number and percentage|0.05|||<|0.05|TWO_SIDED||||||Fisher Exact|||We hypothesized that TORS followed by OPR would improve upper airway obstruction more compared with TORS alone and conservative treatment (control).||||<0.05
72539426|NCT04876482|144608381|OTHER|The Overall Number of Participants Analyzed do not appear to be equal, so we used linear regrssion to compare the mean difference among three groups.|Mean Difference (Final Values)|2.23|||<|0.05|TWO_SIDED||||||Regression, Linear|||We hypothesized that the improvements in the jaw opening muscle strength would be more in patients who underwent TORS combined with OPR than in those who underwent only TORS and those who received conservative treatment (controls).||||<0.05
72627386|NCT05136170|144783690|SUPERIORITY|||||||0.364||||||p-value corresponds to a non-parametric Mann-Whitney-Wilcoxon (Wilcoxon rank sum) test of the comparisons between Cenegermin and Vehicle in all patients.|Wilcoxon (Mann-Whitney)|||Herein analysis for QoL (Impact on Work due to Dry Eye) - Week 4 was reported.||||0.364
72627387|NCT05136170|144783690|SUPERIORITY|||||||0.646||||||p-value corresponds to a non-parametric Mann-Whitney-Wilcoxon (Wilcoxon rank sum) test of the comparisons between Cenegermin and Vehicle in all patients.|Wilcoxon (Mann-Whitney)|||Herein analysis for QoL (Impact on Work due to Dry Eye) - Week 8 was reported.||||0.646
72627388|NCT05136170|144783690|SUPERIORITY|||||||0.739||||||p-value corresponds to a non-parametric Mann-Whitney-Wilcoxon (Wilcoxon rank sum) test of the comparisons between Cenegermin and Vehicle in all patients.|Wilcoxon (Mann-Whitney)|||Herein analysis for QoL (Impact on Work due to Dry Eye) - Week 12 was reported.||||0.739
72627389|NCT05136170|144783690|SUPERIORITY|||||||0.664||||||p-value corresponds to a non-parametric Mann-Whitney-Wilcoxon (Wilcoxon rank sum) test of the comparisons between Cenegermin and Vehicle in all patients.|Wilcoxon (Mann-Whitney)|||Herein analysis for QoL (Impact on Work due to Dry Eye) - Week 16 was reported.||||0.664
72627390|NCT05136170|144783690|SUPERIORITY|||||||0.846||||||p-value corresponds to a two sample (independent group) t-test of the comparisons between Cenegermin and Vehicle in all patients.|t-test, 2 sided|||Herein analysis for TS (Satisfaction with Effectiveness) - Week 4 was reported.||||0.846
72409699|NCT04116229|144327737|OTHER|"Alternative hypothesis: higher levels of adiponectin, an anti-inflammatory marker, will relate to lower levels of putative neuroinflammation in white matter tracts as measured by DBSI hindered fraction after controlling for BMI.~Null hypothesis: Adiponectin levels will not be related to DBSI HF in white matter tracts after controlling for BMI."|Slope|-0.2||||0.52|TWO_SIDED|||||a priori threshold: p \< 0.05|Regression, Linear|||"This is a pilot study with a small sample. Power to detect significant results is therefore low in the current study.~Analyses performed across normal-weight and obese groups."||||0.52
72409700|NCT04116229|144327738|OTHER|"Alternative hypothesis: higher levels of TNF-alpha, a pro-inflammatory marker, will relate to higher levels of putative neuroinflammation in white matter tracts as measured by DBSI restricted fraction after controlling for BMI.~Null hypothesis: TNF-alpha levels will not be related to DBSI RF in white matter tracts after controlling for BMI."|Slope|-0.05||||0.9|TWO_SIDED|||||a priori threshold: p \< 0.05|Regression, Linear|||"This is a pilot study with a small sample. Power to detect significant results is therefore low in the current study.~Analyses performed across normal-weight and obese groups."||||0.90
72409701|NCT04116229|144327738|OTHER|"Alternative hypothesis: higher levels of TNF-alpha, a pro-inflammatory marker, will relate to higher levels of putative neuroinflammation in white matter tracts as measured by DBSI hindered fraction after controlling for BMI.~Null hypothesis: TNF-alpha levels will not be related to DBSI HF in white matter tracts after controlling for BMI."|Slope|0.04||||0.87|TWO_SIDED|||||a priori threshold: p \< 0.05|Regression, Linear|||"This is a pilot study with a small sample. Power to detect significant results is therefore low in the current study.~Analyses performed across normal-weight and obese groups."||||0.87
72539427|NCT04876482|144608382|OTHER|The Overall Number of Participants Analyzed do not appear to be equal, so we used linear regrssion to compare the mean difference among three groups.|Mean Difference (Final Values)|2.45|||<|0.05|TWO_SIDED||||||Regression, Linear|||We hypothesized that the improvements in the tongue protrusion muscle strength would be more in patients who underwent TORS combined with OPR than in those who underwent only TORS and those who received conservative treatment (controls).||||<0.05
72539428|NCT04876482|144608383|OTHER|The Overall Number of Participants Analyzed do not appear to be equal, so we used linear regrssion to compare the mean difference among three groups.|Mean Difference (Final Values)|4.81|||<|0.05|TWO_SIDED||||||Regression, Linear|||We hypothesized that the improvements in the tongue elevation muscle strength would be more in patients who underwent TORS combined with OPR than in those who underwent only TORS and those who received conservative treatment (controls).||||<0.05
72409702|NCT04116229|144327739|OTHER|"Alternative hypothesis: higher levels of MCP-1, a pro-inflammatory marker, will relate to higher levels of putative neuroinflammation in white matter tracts as measured by DBSI restricted fraction after controlling for BMI.~Null hypothesis: MCP-1 levels will not be related to DBSI RF in white matter tracts after controlling for BMI."|Slope|0.34||||0.26|TWO_SIDED|||||a priori threshold: p \< 0.05|Regression, Linear|||This is a pilot study with a small sample. Power to detect significant results is therefore low in the current study. Analyses performed across normal-weight and obese groups.||||0.26
72409703|NCT04116229|144327739|OTHER|"Alternative hypothesis: higher levels of MCP-1, a pro-inflammatory marker, will relate to higher levels of putative neuroinflammation in white matter tracts as measured by DBSI hindered fraction after controlling for BMI.~Null hypothesis: MCP-1 levels will not be related to DBSI HF in white matter tracts after controlling for BMI."|Slope|0.12||||0.71|TWO_SIDED|||||a priori threshold: p \< 0.05|Regression, Linear|||"This is a pilot study with a small sample. Power to detect significant results is therefore low in the current study.~Analyses performed across normal-weight and obese groups."||||0.71
72539429|NCT04876482|144608384|OTHER|The Overall Number of Participants Analyzed do not appear to be equal, so we used linear regrssion to compare the mean difference among three groups.|Mean Difference (Final Values)|7.01|||<|0.05|TWO_SIDED||||||Regression, Linear|||We hypothesized that the improvements in the tongue depression muscle strength would be more in patients who underwent TORS combined with OPR than in those who underwent only TORS and those who received conservative treatment (controls).||||<0.05
72539430|NCT04876482|144608385|OTHER|The Overall Number of Participants Analyzed do not appear to be equal, so we used linear regrssion to compare the mean difference among three groups.|Mean Difference (Final Values)|3.67|||<|0.05|TWO_SIDED||||||Regression, Linear|||We hypothesized that the improvements in the tongue lateralization muscle strength would be more in patients who underwent TORS combined with OPR than in those who underwent only TORS and those who received conservative treatment (controls).||||<0.05
72539431|NCT02576054|144608417|NON_INFERIORITY|The statistical criterion for success requires that the lower bound of two-sided 95% confidence interval (CI) of GMT ratio between boys enrolled in V501-200 and men enrolled in the Phase III study V501-122 be greater than 0.5% for each HPV type|GMT Ratio|1.25|||<|0.001|TWO_SIDED|95.0|1.0|1.57|||ANOVA|Log-transformed data using an analysis of variance model with a term for age-group|GMT Ratio= GMT PN200 divided by GMT PN122|Anti-HPV 6||1.57|1.00|<0.001
72539432|NCT02576054|144608417|NON_INFERIORITY|The statistical criterion for success requires that the lower bound of two-sided 95% confidence interval (CI) of GMT ratio between boys enrolled in V501-200 and men enrolled in the Phase III study V501-122 be greater than 0.5% for each HPV type|GMT Ratio|2.3|||<|0.001|TWO_SIDED|95.0|1.89|2.78|||ANOVA|Log-transformed data using an analysis of variance model with a term for age-group|GMT Ratio = GMT PN200 divided by GMT PN122|Anti-HPV 11||2.78|1.89|<0.001
72539433|NCT02576054|144608417|NON_INFERIORITY|The statistical criterion for success requires that the lower bound of two-sided 95% CI of GMT ratio between boys enrolled in V501-200 and men enrolled in the Phase III study V501-122 be greater than 0.5% for each HPV type|GMT Ratio|1.69|||<|0.001|TWO_SIDED|95.0|1.35|2.11|||ANOVA|Log-transformed data using an analysis of variance model with a term for age-group|GMT Ratio= GMT PN200 divided by GMT PN122|Anti-HPV 16||2.11|1.35|<0.001
72539434|NCT02576054|144608417|NON_INFERIORITY|The statistical criterion for success requires that the lower bound of two-sided 95% CI of GMT ratio between boys enrolled in V501-200 and men enrolled in the Phase III study V501-122 be greater than 0.5% for each HPV type|GMT Ratio|3.05|||<|0.001|TWO_SIDED|95.0|2.33|3.99|||ANOVA|Log-transformed data using an analysis of variance model with a term for age-group|GMT Ratio= GMT PN200 divided by GMT PN122|Anti-HPV 18||3.99|2.33|<0.001
72539435|NCT01190098|144608422|NON_INFERIORITY_OR_EQUIVALENCE|Null hypothesis: there is a non-inferiority region of 4 points.||||||0.027|||||||t-test, 1 sided|||||||0.027
72539436|NCT01190098|144608423|SUPERIORITY_OR_OTHER||Mean Difference (Net)|5.7||||0.23|TWO_SIDED||||||t-test, 2 sided|||||||0.23
72539437|NCT01190098|144608424|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.3||||0.84|TWO_SIDED||||||t-test, 2 sided|||||||0.84
72575311|NCT01338870|144676546|SUPERIORITY_OR_OTHER||LS mean difference|-0.12|STANDARD_ERROR_OF_MEAN|0.058||0.0234|TWO_SIDED|95.0|-0.19|-0.04|||Mixed Models Analysis|||Week 1: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction, baseline-by-treatment interaction, baseline-by-treatment-by-time interaction as the covariates, time was repeated for participant.||-0.04|-0.19|0.0234
72627391|NCT05136170|144783690|SUPERIORITY|||||||0.248||||||p-value corresponds to a two sample (independent group) t-test of the comparisons between Cenegermin and Vehicle in all patients.|t-test, 2 sided|||Herein analysis for TS (Satisfaction with Effectiveness) - Week 8 was reported.||||0.248
72539438|NCT01190098|144608425|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.8||||0.37|TWO_SIDED||||||t-test, 2 sided|||||||0.37
72539439|NCT01190098|144608426|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.8||||0.33|TWO_SIDED||||||t-test, 2 sided|||||||0.33
72539440|NCT01190098|144608427|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.1||||0.92|TWO_SIDED||||||t-test, 2 sided|||||||0.92
72539441|NCT01190098|144608428|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.0||||0.69|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.69
72539442|NCT01190098|144608429|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.2||||0.95|TWO_SIDED||||||t-test, 2 sided|||||||0.95
72627392|NCT05136170|144783690|SUPERIORITY|||||||0.341||||||p-value corresponds to a two sample (independent group) t-test of the comparisons between Cenegermin and Vehicle in all patients.|t-test, 2 sided|||Herein analysis for TS (Satisfaction with Effectiveness) - Week 12 was reported.||||0.341
72627393|NCT05136170|144783690|SUPERIORITY|||||||0.413||||||p-value corresponds to a two sample (independent group) t-test of the comparisons between Cenegermin and Vehicle in all patients|t-test, 2 sided|||Herein analysis for TS (Satisfaction with Effectiveness) - Week 16 was reported.||||0.413
72539443|NCT02957682|144608430|NON_INFERIORITY|Upper confidence interval (CI) limit was compared to the noninferiority margin, which was 0.2%, and noninferiority was declared if the upper CI limit was below the noninferiority margin.|Least Square (LS) Mean Difference|-0.02||||0.6055|TWO_SIDED|95.0|-0.094|0.055||P-value was taken from mixed-effect model with repeated measures (MMRM) analysis.|Mixed-effect Model Repeated Measures||Model: fixed categorical effects of treatment group, randomization strata as per IVRS, time point, treatment-by-time point, strata-by-time point, continuous fixed covariates of baseline SWMS raw score value, baseline value by time-point interaction.|Change at Week 96||0.055|-0.094|0.6055
72539444|NCT00149669|144608443|SUPERIORITY||Odds Ratio (OR)|8.67|||<|0.01|TWO_SIDED|95.0|4.24|17.73|||General Estimating Equation (GEE)|||||17.73|4.24|<0.01
72539445|NCT00149669|144608444|SUPERIORITY||Odds Ratio (OR)|0.91||||0.82|TWO_SIDED|95.0|0.43|1.95|||General Estimating Equation (GEE)|||||1.95|.43|0.82
72539446|NCT00149669|144608445|SUPERIORITY||Odds Ratio (OR)|0.61|||=|0.19|TWO_SIDED|95.0|0.29|1.26|||General Estimating Equation (GEE)|||||1.26|0.29|=0.19
72539447|NCT02458365|144608450|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.62|||<|0.0001|TWO_SIDED|95.0|0.51|0.75|||Regression, Logistic|Hierarchical logistic regression using random intercepts for school to account for the clustered study design||||.75|.51|<.0001
72539448|NCT02458365|144608450|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.55|||<|0.0001|TWO_SIDED|95.0|0.45|0.68|||Regression, Linear|Adjusted model that controls for potential confounds and covariates, including variables that predicted non-response and the primary outcomes.||||.68|.45|<.0001
72539449|NCT02458365|144608451|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.7|||<|0.001|TWO_SIDED|95.0|0.57|0.84|||Regression, Logistic|Hierarchical logistic regression using random intercepts for school to account for the clustered study design||||.84|.57|<.001
72539450|NCT02458365|144608451|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.61|||<|0.0001|TWO_SIDED|95.0|0.5|0.75|||Regression, Logistic|Adjusted model that controls for potential confounds and covariates, including variables that predicted non-response and the primary outcomes.||||.75|.50|<.0001
72539451|NCT02458365|144608452|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.53|||<|0.0001|TWO_SIDED|95.0|0.43|0.67|||Regression, Logistic|Hierarchical logistic regression using random intercepts for school to account for the clustered study design||||.67|.43|<.0001
72539452|NCT02458365|144608452|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.45|||<|0.0001|TWO_SIDED|95.0|0.36|0.56|||Regression, Logistic|Adjusted model that controls for potential confounds and covariates, including variables that predicted non-response and the primary outcomes.||||.56|.36|<.0001
72539453|NCT02458365|144608453|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.5|||<|0.0001|TWO_SIDED|95.0|0.41|0.62|||Regression, Logistic|Hierarchical logistic regression using random intercepts for school to account for the clustered study design||||.62|.41|<.0001
72539454|NCT02458365|144608453|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.44|||<|0.0001|TWO_SIDED|95.0|0.35|0.54|||Regression, Logistic|Adjusted model that controls for potential confounds and covariates, including variables that predicted non-response and the primary outcomes.||||.54|.35|<.0001
72539455|NCT02458365|144608454|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.55||||0.001|TWO_SIDED|95.0|0.38|0.78|||Regression, Logistic|Hierarchical logistic regression using random intercepts for school to account for the clustered study design||||.78|.38|.001
72539456|NCT02458365|144608454|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.6||||0.013|TWO_SIDED|95.0|0.4|0.9|||Regression, Logistic|Adjusted model that controls for potential confounds and covariates, including variables that predicted non-response and the primary outcomes.||||.90|.40|.013
72575312|NCT01338870|144676546|SUPERIORITY_OR_OTHER||LS mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.058||0.04|TWO_SIDED|80.0|-0.18|-0.03|||Mixed Models Analysis|||Week 1: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction, baseline-by-treatment interaction, baseline-by-treatment-by-time interaction as the covariates, time was repeated for participant.||-0.03|-0.18|0.0400
72627394|NCT05136170|144783690|SUPERIORITY|||||||0.927||||||p-value corresponds to a non-parametric Mann-Whitney-Wilcoxon (Wilcoxon rank sum) test of the comparisons between Cenegermin and Vehicle in all patients.|Wilcoxon (Mann-Whitney)|||Herein analysis for TS (Treatment Bother/Inconvenience) - Week 4 was reported.||||0.927
72627395|NCT05136170|144783690|SUPERIORITY|||||||0.914||||||p-value corresponds to a non-parametric Mann-Whitney-Wilcoxon (Wilcoxon rank sum) test of the comparisons between Cenegermin and Vehicle in all patients.|Wilcoxon (Mann-Whitney)|||Herein analysis for TS (Treatment Bother/Inconvenience) - Week 8 was reported.||||0.914
72539457|NCT02458365|144608455|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.53|||<|0.001|TWO_SIDED|95.0|0.37|0.76|||Regression, Logistic|Hierarchical logistic regression using random intercepts for school to account for the clustered study design||||.76|.37|<.001
72539458|NCT02458365|144608455|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.54||||0.004|TWO_SIDED|95.0|0.35|0.82|||Regression, Logistic|Adjusted model that controls for potential confounds and covariates, including variables that predicted non-response and the primary outcomes.||||.82|.35|.004
72539459|NCT02458365|144608456|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.53||||0.002|TWO_SIDED|95.0|0.35|0.78|||Regression, Logistic|Hierarchical logistic regression using random intercepts for school to account for the clustered study design||||.78|.35|.002
72539460|NCT02458365|144608456|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.5||||0.005|TWO_SIDED|95.0|0.31|0.81|||Regression, Logistic|Adjusted model that controls for potential confounds and covariates, including variables that predicted non-response and the primary outcomes.||||.81|.31|.005
72539461|NCT02458365|144608457|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.43|||<|0.0001|TWO_SIDED|95.0|0.29|0.64|||Regression, Logistic|Hierarchical logistic regression using random intercepts for school to account for the clustered study design||||.64|.29|<.0001
72539462|NCT02458365|144608457|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.47||||0.003|TWO_SIDED|95.0|0.29|0.77|||Regression, Logistic|Adjusted model that controls for potential confounds and covariates, including variables that predicted non-response and the primary outcomes.||||.77|.29|.003
72539463|NCT02499406|144608480|SUPERIORITY||||||>|0.016||||||a priori threshold for significance adjusted to p = .016 for multiple comparisons|paired sample t-test|df=14||Null hypothesis is that there is no difference between baseline assessment and this 3-month assessment.||||>0.016
72539464|NCT02499406|144608481|SUPERIORITY||||||<|0.016||||||p value was calculated and found to be below the a priori threshold for significance, which was adjusted to p = .016 for multiple comparisons|paired sample t-test|df=11||Null hypothesis is that there is no difference between baseline assessment and this 6-month assessment.||||<0.016
72539465|NCT02499406|144608482|SUPERIORITY||||||<|0.016||||||a priori threshold for significance adjusted to p = .016 for multiple comparisons|paired sample t-test|df=11||Null hypothesis is that there is no difference between baseline assessment and this 9-month assessment.||||<0.016
72539466|NCT02499406|144608483|SUPERIORITY||||||<|0.016||||||a priori threshold for significance adjusted to p = .016 for multiple comparisons|paired samples t test|df=14||Null hypothesis is that there is no difference in paired samples between baseline and 3-month assessment||||<0.016
72539467|NCT02499406|144608484|SUPERIORITY||||||<|0.016||||||a priori threshold for significance adjusted to p = .016 for multiple comparisons|paired samples t test|df=10||Null hypothesis is no difference between baseline and this 6-month assessment.||||<0.016
72539468|NCT02499406|144608485|SUPERIORITY||||||<|0.016||||||a priori threshold for significance adjusted to p = .016 for multiple comparisons|paired samples t test|df=11||Null hypothesis is no difference between baseline and this 9-month assessment.||||<0.016
72539469|NCT02499406|144608486|SUPERIORITY||||||>|0.016||||||a priori threshold for significance adjusted to p = .016 for multiple comparisons|paired sample t test|df=14||Null hypothesis is that there is no difference between baseline assessment and this 3-month assessment.||||> 0.016
72539470|NCT02499406|144608487|SUPERIORITY||||||=|0.016||||||a priori threshold for significance adjusted to p = .016 for multiple comparisons|paired sample t-test|df=10||Null hypothesis is that there is no difference between baseline assessment and this 6-month assessment.||||=.016
72539471|NCT02499406|144608488|SUPERIORITY||||||<|0.016||||||a priori threshold for significance adjusted to p = .016 for multiple comparisons|paired sample t-test|df=11||Null hypothesis is that there is no difference between baseline assessment and this 9-month assessment.||||<0.016
72539472|NCT00390949|144608529|SUPERIORITY||||||<|0.05||||||The p-value reported above is not simply a statement of the threshold for significance used in the study. The p-value for this comparison was calculated at the time of the study and was found to be less than 0.5.|Regression, Logistic|Adjustments for community pair, age-group and value of variable at baseline||||||<0.05
72539473|NCT00390949|144608530|SUPERIORITY||||||<|0.05||||||The p-value reported above is not simply a statement of the threshold for significance used in the study. The p-value for this comparison was calculated at the time of the study and was found to be less than 0.5.|Regression, Logistic|Adjusted for community pair, age-group and value of variable at baseline||||||<0.05
72539474|NCT00390949|144608531|SUPERIORITY||||||<|0.05||||||The p-value reported above is not simply a statement of the threshold for significance used in the study. The p-value for this comparison was calculated at the time of the study and was found to be less than 0.5.|Regression, Logistic|||||||<0.05
72539475|NCT00390949|144608532|SUPERIORITY||||||<|0.05||||||The p-value reported above is not simply a statement of the threshold for significance used in the study. The p-value for this comparison was calculated at the time of the study and was found to be less than 0.5.|Regression, Logistic|Adjusted for community pair, age-group and value at baseline||||||<0.05
72539476|NCT00390949|144608533|SUPERIORITY||||||<|0.05||||||The p-value reported above is not simply a statement of the threshold for significance used in the study. The p-value for this comparison was calculated at the time of the study and was found to be less than 0.5.|Regression, Logistic|Adjusted for community pair and age-group||||||<0.05
72539477|NCT00390949|144608534|SUPERIORITY||||||<|0.05||||||The p-value reported above is not simply a statement of the threshold for significance used in the study. The p-value for this comparison was calculated at the time of the study and was found to be less than 0.5.|Regression, Logistic|Adjusted for community pair, age-group and value at baseline||||||<0.05
72539478|NCT04840901|144608576|EQUIVALENCE|PK parameters were powered to test equivalence with a power of 90% that the 90% confidence interval (CI) of the geometric mean ratio fall within 0.8 to 1.25 equivalence margin.|Ratio of Geometric LS Mean|1.09|||||TWO_SIDED|90.0|1.03|1.16|||ANCOVA|||||1.16|1.03|
72539479|NCT04840901|144608577|EQUIVALENCE|PK parameters were powered to test equivalence with a power of 90% that the 90% confidence interval (CI) of the geometric mean ratio fall within 0.8 to 1.25 equivalence margin.|Ratio of Geometric LS Mean|1.07|||||TWO_SIDED|90.0|1.02|1.14|||ANCOVA|||||1.14|1.02|
72627396|NCT05136170|144783690|SUPERIORITY|||||||0.564||||||p-value corresponds to a non-parametric Mann-Whitney-Wilcoxon (Wilcoxon rank sum) test of the comparisons between Cenegermin and Vehicle in all patients.|Wilcoxon (Mann-Whitney)|||Herein analysis for TS (Treatment Bother/Inconvenience) - Week 12 was reported.||||0.564
72539480|NCT04840901|144608578|EQUIVALENCE|PK parameters were powered to test equivalence with a power of 90% that the 90% confidence interval (CI) of the geometric mean ratio fall within 0.8 to 1.25 equivalence margin.|Ratio of Geometric LS Mean|1.09|||||TWO_SIDED|90.0|1.03|1.14|||ANCOVA|||||1.14|1.03|
72539481|NCT05354206|144608580|SUPERIORITY||Mean Difference (Final Values)|0.405|STANDARD_DEVIATION|0.285|<|0.05|TWO_SIDED|||||p-values have not been adjusted for multiple comparisons|t-test, 2 sided||Difference of RST from 1 for hip range of motion task without stimulation.|"Reticulospinal tract (RST) contribution computed as RST = (visual - startle)/(visual - auditory) reaction times, where a RST value greater than 1 would indicate a significant contribution of the reticulospinal tract for a given task.~A one sample t-test (or Wilcoxon signed-rank test for non-normally distributed data) was used to test the hypothesis that the RST contribution for a given movement was significantly greater than 1."||||<0.05
72539482|NCT04936334|144608585|SUPERIORITY||McNemar|0.03|||<|0.05|TWO_SIDED||||||McNemar|||||||<0.05
72539483|NCT02209272|144608608|SUPERIORITY|||||||0.82|||||||t-test, 2 sided|||||||0.82
72539484|NCT02209272|144608609|SUPERIORITY|||||||0.21|||||||t-test, 2 sided|||||||0.21
72539485|NCT02209272|144608610|SUPERIORITY|||||||0.57|||||||t-test, 2 sided|||||||0.57
72539486|NCT00110084|144608618|SUPERIORITY_OR_OTHER||Proportion of confirmed responses (%)|50.0|||||TWO_SIDED|95.0|36.0|64.0|||||95% Confidence intervals were calculated for the true confirmed response rate using properties of the binomial distribution.|Proportion of confirmed responses was estimated by the number of patients who achieved a confirmed response divided by the total number of assessable patients.||64|36|
72539487|NCT00663039|144608632|SUPERIORITY|||||||0.758|||||||Wilcoxon (Mann-Whitney)|||Comparison of Overall Affect Scores between Oxytocin and Placebo Arms||||0.758
72539488|NCT00663039|144608632|SUPERIORITY|||||||0.779|||||||Wilcoxon (Mann-Whitney)|||Comparison of Overall Social Skill scores between Oxytocin and Placebo arms||||0.779
72539489|NCT00663039|144608633|SUPERIORITY|||||||0.578|||||||Wilcoxon (Mann-Whitney)|||Comparison of HVLT Trial 1 scores between Oxytocin and Placebo Arms||||0.578
72539490|NCT00663039|144608633|SUPERIORITY|||||||0.28|||||||Wilcoxon (Mann-Whitney)|||Comparison of HVLT Trial 2 scores between Oxytocin and Placebo Arms||||0.28
72539491|NCT00663039|144608633|SUPERIORITY|||||||0.707|||||||Wilcoxon (Mann-Whitney)|||Comparison of HVLT Trial 3 scores between Oxytocin and Placebo Arms||||0.707
72539492|NCT00663039|144608634|SUPERIORITY|||||||0.391|||||||Wilcoxon (Mann-Whitney)|||Comparison of the total amount of money offered during the trust game between the Oxytocin and Placebo arms||||0.391
72539493|NCT00663039|144608635|SUPERIORITY|||||||0.559|||||||Wilcoxon (Mann-Whitney)|||Comparison of RVIP Practice Mean Target Reaction Time between Oxytocin and Placebo arms.||||0.559
72539494|NCT00663039|144608635|SUPERIORITY|||||||0.858|||||||Wilcoxon (Mann-Whitney)|||Comparison of RVIP First Half Mean Target Reaction Time between Oxytocin and Placebo arms.||||0.858
72539495|NCT00663039|144608635|SUPERIORITY|||||||0.514|||||||Wilcoxon (Mann-Whitney)|||Comparison of RVIP Practice Mean False Alarms Reaction Time between Oxytocin and Placebo arms||||0.514
72539496|NCT00663039|144608635|SUPERIORITY|||||||0.088|||||||Wilcoxon (Mann-Whitney)|||Comparison of RVIP First Half Mean False Alarms Reaction Time between Oxytocin and Placebo arms||||0.088
72539497|NCT00663039|144608636|SUPERIORITY|||||||0.296|||||||Wilcoxon (Mann-Whitney)|||Comparison of RVIP Practice Mean Target Hits between Oxytocin and Placebo arms.||||0.296
72539498|NCT00663039|144608636|SUPERIORITY|||||||0.136|||||||Wilcoxon (Mann-Whitney)|||Comparison of RVIP First Half Mean Target Hits between Oxytocin and Placebo arms.||||0.136
72539499|NCT00663039|144608636|SUPERIORITY|||||||0.47|||||||Wilcoxon (Mann-Whitney)|||Comparison of RVIP Practice Mean False Alarms between Oxytocin and Placebo arms.||||0.47
72539500|NCT00663039|144608636|SUPERIORITY|||||||0.702|||||||Wilcoxon (Mann-Whitney)|||Comparison of RVIP First Half Mean Target Hits between Oxytocin and Placebo arms.||||0.702
72539501|NCT00663039|144608637|SUPERIORITY|||||||0.451|||||||Wilcoxon (Mann-Whitney)|||Comparison of Brief Assessments of Cognition for Schizophrenia scores between the Oxytocin and Placebo arms.||||0.451
72539502|NCT00663039|144608638|SUPERIORITY|||||||0.9|||||||Wilcoxon (Mann-Whitney)|||||||0.9
72539503|NCT00663039|144608639|SUPERIORITY|||||||0.946|||||||Wilcoxon (Mann-Whitney)|||Comparison of Reading the Mind in the Eyes total scores between Oxytocin and Placebo arms||||0.946
72539504|NCT00663039|144608640|SUPERIORITY|||||||0.016|||||||Wilcoxon (Mann-Whitney)|||Comparison the Facial Affect Recognition Total scores between Oxytocin and Placebo arms||||0.016
72539505|NCT00663039|144608640|SUPERIORITY|||||||0.185|||||||Wilcoxon (Mann-Whitney)|||Comparison the Facial Affect Recognition Hits between Oxytocin and Placebo arms||||0.185
72539506|NCT00663039|144608640|SUPERIORITY|||||||0.404|||||||Wilcoxon (Mann-Whitney)|||Comparison the Facial Affect Recognition False Alarms between Oxytocin and Placebo arms||||0.404
72539507|NCT05016765|144608657|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|paired t-test||||||<0.001
72539508|NCT05016765|144608657|OTHER|Pearson correlation test|Pearson's R|0.21||||0.33|TWO_SIDED|95.0|-0.22|0.56|||Regression, Linear|Pearson's R||Correlation of this Outcome measure (change in tic frequency with stimulation during this study) with the change in tic frequency (measured as the number of 10-second tic-free intervals) during active, rhythmic stimulation in the randomized, controlled trial of MNS that all participants had previously completed.||0.56|-0.22|0.33
72539509|NCT05016765|144608658|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|Paired Samples Wilcoxon Test||||||<0.001
72539510|NCT05016765|144608658|OTHER|Pearson's R|Pearson's R|0.36||||0.08|TWO_SIDED|95.0|-0.05|0.66|||Regression, Linear|Pearson's R||Correlation of this Outcome measure (change in tic intensity during this study) with change in tic intensity during active, rhythmic stimulation during the randomized, controlled trial that all participants had previously completed.||0.66|-0.05|0.08
72539511|NCT05016765|144608663|OTHER|Traditional comparative||||||0.84|||||||Paired Sample t-Test, 2-Sided|||||||0.84
72539512|NCT04101721|144608679|NON_INFERIORITY|Non-inferiority margin is 5%|Adjusted difference|1.81|||||TWO_SIDED|95.1|-15.71|19.33||||||Difference with confidence interval (CI) is calculated using Mantel-Haenszel weighting scheme adjusted by baseline ROP status.||19.33|-15.71|
72539513|NCT04101721|144608680|SUPERIORITY||Adjusted difference|-3.66|||||TWO_SIDED|95.1|-19.86|12.54||||||Difference with confidence interval (CI) is calculated using Mantel-Haenszel weighting scheme adjusted by baseline ROP status.||12.54|-19.86|
72539514|NCT04101721|144608681|SUPERIORITY||Adjusted difference|10.1|||||TWO_SIDED|95.1|-9.83|30.02||||||Difference with confidence interval (CI) is calculated using Mantel-Haenszel weighting scheme adjusted by baseline ROP status||30.02|-9.83|
72539515|NCT00038467|144608692|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.69||||3e-05|TWO_SIDED|95.0|0.58|0.82|||Log Rank|||||0.82|0.58|0.00003
72539516|NCT00038467|144608693|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.913||||0.15737|TWO_SIDED|95.0|0.806|1.036|||Log Rank|||||1.036|0.806|0.15737
72539517|NCT00038467|144608695|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.43|||<|0.0001|TWO_SIDED|95.0|1.63|3.23|||t-test, 2 sided|||6 months on-treatment (lumbar spine): p-value was estimated using 2-sided t-test.||3.23|1.63|<0.0001
72539518|NCT00038467|144608695|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.18||||0.0002|TWO_SIDED|95.0|0.57|1.79|||t-test, 2 sided|||6 months on-treatment (total hip): p-value was estimated using 2-sided t-test.||1.79|0.57|0.0002
72539519|NCT00038467|144608695|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.79|||<|0.0001|TWO_SIDED|95.0|1.77|3.81|||t-test, 2 sided|||12 months on-treatment (lumbar spine): p-value was estimated using 2-sided t-test.||3.81|1.77|<0.0001
72539520|NCT00038467|144608695|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.79|||<|0.0001|TWO_SIDED|95.0|1.12|2.46|||t-test, 2 sided|||12 months on-treatment (total hip): p-value was estimated using 2-sided t-test.||2.46|1.12|<0.0001
72539521|NCT00038467|144608695|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.22|||<|0.0001|TWO_SIDED|95.0|2.1|4.35|||t-test, 2 sided|||24 months on-treatment (lumbar spine): p-value was estimated using 2-sided t-test.||4.35|2.10|<0.0001
72539522|NCT00038467|144608695|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.9|||<|0.0001|TWO_SIDED|95.0|1.1|2.69|||t-test, 2 sided|||24 months on-treatment (total hip): p-value was estimated using 2-sided t-test.||2.69|1.10|<0.0001
72539523|NCT00038467|144608704|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.45||||0.5|TWO_SIDED|95.0|-1.76|0.86|||t-test, 2 sided|||3 months: p-value was estimated using 2-sided t-test.||0.86|-1.76|0.500
72539524|NCT00038467|144608704|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.1||||0.009|TWO_SIDED|95.0|-3.67|-0.52|||t-test, 2 sided|||6 months: p-value was estimated using 2-sided t-test.||-0.52|-3.67|0.009
72539525|NCT00038467|144608704|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.35||||0.079|TWO_SIDED|95.0|-2.86|0.16|||t-test, 2 sided|||9 months: p-value was estimated using 2-sided t-test.||0.16|-2.86|0.079
72539526|NCT00038467|144608704|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.27||||0.729|TWO_SIDED|95.0|-1.24|1.77|||t-test, 2 sided|||12 months: p-value was estimated using 2-sided t-test.||1.77|-1.24|0.729
72539527|NCT00038467|144608704|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.84||||0.302|TWO_SIDED|95.0|-2.43|0.75|||t-test, 2 sided|||18 months: p-value was estimated using 2-sided t-test.||0.75|-2.43|0.302
72539528|NCT00038467|144608704|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.11||||0.187|TWO_SIDED|95.0|-2.76|0.54|||t-test, 2 sided|||24 months: p-value was estimated using 2-sided t-test.||0.54|-2.76|0.187
72539529|NCT00038467|144608705|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.65||||0.26|TWO_SIDED|95.0|-1.8|0.49|||t-test, 2 sided|||3 months: p-value was estimated using 2-sided t-test.||0.49|-1.80|0.260
72539530|NCT00038467|144608705|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.79||||0.209|TWO_SIDED|95.0|-2.02|0.44|||t-test, 2 sided|||6 months: p-value was estimated using 2-sided t-test.||0.44|-2.02|0.209
72539531|NCT00038467|144608705|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.23||||0.698|TWO_SIDED|95.0|-1.38|0.92|||t-test, 2 sided|||9 months: p-value was estimated using 2-sided t-test.||0.92|-1.38|0.698
72627397|NCT05136170|144783690|SUPERIORITY|||||||0.489||||||p-value corresponds to a non-parametric Mann-Whitney-Wilcoxon (Wilcoxon rank sum) test of the comparisons between Cenegermin and Vehicle in all patients.|Wilcoxon (Mann-Whitney)|||Herein analysis for TS (Treatment Bother/Inconvenience) - Week 16 was reported.||||0.489
72539532|NCT00038467|144608705|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.83||||0.192|TWO_SIDED|95.0|-0.42|2.09|||t-test, 2 sided|||12 months: p-value was estimated using 2-sided t-test.||2.09|-0.42|0.192
72539533|NCT00038467|144608705|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.16||||0.813|TWO_SIDED|95.0|-1.46|1.15|||t-test, 2 sided|||18 months: p-value was estimated using 2-sided t-test.||1.15|-1.46|0.813
72539534|NCT00038467|144608705|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.42||||0.537|TWO_SIDED|95.0|-0.91|1.75|||t-test, 2 sided|||24 months: p-value was estimated using 2-sided t-test.||1.75|-0.91|0.537
72539535|NCT00038467|144608706|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.52||||0.727|TWO_SIDED|95.0|-3.46|2.42|||t-test, 2 sided|||3 months: p-value was estimated using 2-sided t-test.||2.42|-3.46|0.727
72539536|NCT00038467|144608706|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.08||||0.047|TWO_SIDED|95.0|-6.12|-0.05|||t-test, 2 sided|||6 months: p-value was estimated using 2-sided t-test.||-0.05|-6.12|0.047
72539537|NCT00038467|144608706|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9||||0.553|TWO_SIDED|95.0|-3.88|2.08|||t-test, 2 sided|||9 months: p-value was estimated using 2-sided t-test.||2.08|-3.88|0.553
72539538|NCT00038467|144608706|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.91||||0.563|TWO_SIDED|95.0|-2.17|3.99|||t-test, 2 sided|||12 months: p-value was estimated using 2-sided t-test.||3.99|-2.17|0.563
72539539|NCT00038467|144608706|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.73||||0.643|TWO_SIDED|95.0|-3.83|2.36|||t-test, 2 sided|||18 months: p-value was estimated using 2-sided t-test.||2.36|-3.83|0.643
72539540|NCT00038467|144608706|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.91||||0.126|TWO_SIDED|95.0|-6.63|0.82|||t-test, 2 sided|||24 months: p-value was estimated using 2-sided t-test.||0.82|-6.63|0.126
72539541|NCT00038467|144608707|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3||||0.265|TWO_SIDED|95.0|-0.83|0.23|||t-test, 2 sided|||3 months: p-value was estimated using 2-sided t-test.||0.23|-0.83|0.265
72627398|NCT05136170|144783690|SUPERIORITY|||||||0.082||||||p-value corresponds to a two sample (independent group) t-test of the comparisons between Cenegermin and Vehicle in all patients.|t-test, 2 sided|||Herein analysis for Symptom-Bother - Week 4||||0.082
72627399|NCT05136170|144783690|SUPERIORITY|||||||0.848||||||p-value corresponds to a two sample (independent group) t-test of the comparisons between Cenegermin and Vehicle in all patients.|t-test, 2 sided|||Herein analysis for Symptom-Bother - Week 8 was reported.||||0.848
72627400|NCT05136170|144783690|SUPERIORITY|||||||0.805||||||p-value corresponds to a two sample (independent group) t-test of the comparisons between Cenegermin and Vehicle in all patients.|t-test, 2 sided|||Herein analysis for Symptom-Bother - Week 12 was reported.||||0.805
72627401|NCT05136170|144783690|SUPERIORITY|||||||0.833||||||p-value corresponds to a non-parametric Mann-Whitney-Wilcoxon (Wilcoxon rank sum) test of the comparisons between Cenegermin and Vehicle in all patients.|Wilcoxon (Mann-Whitney)|||Herein analysis for Symptom-Bother - Week 16 was reported.||||0.833
72627402|NCT05136170|144783693|SUPERIORITY||||||<|0.001||||||p-value corresponds to a non-parametric Mann-Whitney-Wilcoxon (Wilcoxon rank sum) test of the comparisons between Cenegermin and Vehicle in all patients.|Wilcoxon (Mann-Whitney)|||||||<0.001
72627403|NCT05136170|144783694|SUPERIORITY|||||||0.046||||||p-value corresponds to a non-parametric Mann-Whitney-Wilcoxon (Wilcoxon rank sum) test of the comparisons between Cenegermin and Vehicle in all patients.|Wilcoxon (Mann-Whitney)|||||||0.046
72627404|NCT05136170|144783695|SUPERIORITY|||||||0.34||||||p-value corresponds to a non-parametric Mann-Whitney-Wilcoxon (Wilcoxon rank sum) test of the comparisons between Cenegermin and Vehicle in all patients.|Wilcoxon (Mann-Whitney)|||||||0.34
72627405|NCT05136170|144783696|SUPERIORITY|||||||0.017||||||p-value corresponds to a non-parametric Mann-Whitney-Wilcoxon (Wilcoxon rank sum) test of the comparisons between Cenegermin and Vehicle in all patients.|Wilcoxon (Mann-Whitney)|||Herein analysis for Global Score - Week 2 was reported||||0.017
72627406|NCT05136170|144783696|SUPERIORITY|||||||0.339||||||p-value corresponds to a non-parametric Mann-Whitney-Wilcoxon (Wilcoxon rank sum) test of the comparisons between Cenegermin and Vehicle in all patients.|Wilcoxon (Mann-Whitney)|||Herein analysis for Global Score - Week 4 was reported||||0.339
72627407|NCT05136170|144783696|SUPERIORITY|||||||0.004||||||p-value corresponds to a two sample (independent group) t-test of the comparisons between Cenegermin and Vehicle in all patients.|t-test, 2 sided|||Herein analysis for Severity - Week 2 was reported.||||0.004
72539542|NCT00038467|144608707|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.21||||0.0002|TWO_SIDED|95.0|-1.84|-0.57|||t-test, 2 sided|||6 months: p-value was estimated using 2-sided t-test.||-0.57|-1.84|0.0002
72539543|NCT00038467|144608707|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.44||||0.132|TWO_SIDED|95.0|-1.0|0.13|||t-test, 2 sided|||9 months: p-value was estimated using 2-sided t-test.||0.13|-1.00|0.132
72539544|NCT00038467|144608707|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.14||||0.635|TWO_SIDED|95.0|-0.7|0.43|||t-test, 2 sided|||12 months: p-value was estimated using 2-sided t-test.||0.43|-0.70|0.635
72539545|NCT00038467|144608707|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.21||||0.449|TWO_SIDED|95.0|-0.75|0.33|||t-test, 2 sided|||18 months: p-value was estimated using 2-sided t-test.||0.33|-0.75|0.449
72539546|NCT00038467|144608707|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.22||||0.454|TWO_SIDED|95.0|-0.81|0.36|||t-test, 2 sided|||24 months: p-value was estimated using 2-sided t-test.||0.36|-0.81|0.454
72539547|NCT00038467|144608708|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.12||||0.712|TWO_SIDED|95.0|-0.53|0.335|||t-test, 2 sided|||3 months: p-value was estimated using 2-sided t-test.||0.335|-0.53|0.712
72539548|NCT00038467|144608708|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.05||||0.899|TWO_SIDED|95.0|-0.65|0.356|||t-test, 2 sided|||6 months: p-value was estimated using 2-sided t-test.||0.356|-0.65|0.899
72539549|NCT00038467|144608708|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.05||||0.882|TWO_SIDED|95.0|-0.76|0.359|||t-test, 2 sided|||9 months: p-value was estimated using 2-sided t-test.||0.359|-0.76|0.882
72539550|NCT00038467|144608708|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.19||||0.604|TWO_SIDED|95.0|-0.54|0.37|||t-test, 2 sided|||18 months: p-value was estimated using 2-sided t-test.||0.37|-0.54|0.604
72539551|NCT00038467|144608708|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.26||||0.562|TWO_SIDED|95.0|-1.16|0.454|||t-test, 2 sided|||24 months: p-value was estimated using 2-sided t-test.||0.454|-1.16|0.562
72539552|NCT00038467|144608709|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01||||0.892|TWO_SIDED|95.0|-0.2|0.18|||t-test, 2 sided|||3 months: p-value was estimated using 2-sided t-test.||0.18|-0.20|0.892
72539553|NCT00038467|144608709|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.02||||0.881|TWO_SIDED|95.0|-0.21|0.24|||t-test, 2 sided|||6 months: p-value was estimated using 2-sided t-test.||0.24|-0.21|0.881
72539554|NCT00038467|144608709|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01||||0.883|TWO_SIDED|95.0|-0.18|0.21|||t-test, 2 sided|||9 months: p-value was estimated using 2-sided t-test.||0.21|-0.18|0.883
72539555|NCT00038467|144608709|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.06||||0.604|TWO_SIDED|95.0|-0.16|0.27|||t-test, 2 sided|||12 months: p-value was estimated using 2-sided t-test.||0.27|-0.16|0.604
72627408|NCT05136170|144783696|SUPERIORITY|||||||0.292||||||p-value corresponds to a non-parametric Mann-Whitney-Wilcoxon (Wilcoxon rank sum) test of the comparisons between Cenegermin and Vehicle in all patients.|Wilcoxon (Mann-Whitney)|||Herein analysis for Severity - Week 4 was reported.||||0.292
72627409|NCT05136170|144783696|SUPERIORITY|||||||0.09||||||p-value corresponds to a non-parametric Mann-Whitney-Wilcoxon (Wilcoxon rank sum) test of the comparisons between Cenegermin and Vehicle in all patients.|Wilcoxon (Mann-Whitney)|||Herein analysis for Frequency - Week 2 was reported.||||0.09
72627410|NCT05136170|144783696|SUPERIORITY|||||||0.54||||||p-value corresponds to a non-parametric Mann-Whitney-Wilcoxon (Wilcoxon rank sum) test of the comparisons between Cenegermin and Vehicle in all patients.|Wilcoxon (Mann-Whitney)|||Herein analysis for Frequency - Week 4 was reported.||||0.54
72627411|NCT05136170|144783697|SUPERIORITY|||||||0.0064||||||p-value corresponds to Chi-square test of the comparisons between Cenegermin and Vehicle in all patients.|Chi-squared|||Herein analysis for Worsening in symptom scores (SANDE global score) was reported.||||0.0064
72627412|NCT05136170|144783697|SUPERIORITY|||||||1||||||p-value corresponds to a Fisher's exact test of the comparisons between Cenegermin and Vehicle in all patients.|Fisher Exact|||Herein analysis for NEI score \>= 50% was reported.||||1
72627413|NCT05136170|144783697|SUPERIORITY|||||||0.0034||||||p-value corresponds to Chi-square test of the comparisons between Cenegermin and Vehicle in all patients.|Chi-squared|||Herein analysis for Worsening in symptom scores and/or NEI score \>= 50 was reported.||||0.0034
72627414|NCT05136170|144783698|SUPERIORITY||||||<|0.001||||||p-value corresponds to a non-parametric Mann-Whitney-Wilcoxon (Wilcoxon rank sum) test of the comparisons between Cenegermin and Vehicle in all participants.|Wilcoxon (Mann-Whitney)|||||||<0.001
72539556|NCT00038467|144608709|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.18||||0.118|TWO_SIDED|95.0|-0.05|0.41|||t-test, 2 sided|||18 months: p-value was estimated using 2-sided t-test.||0.41|-0.05|0.118
72539557|NCT00038467|144608709|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.12||||0.307|TWO_SIDED|95.0|-0.11|0.34|||t-test, 2 sided|||24 months: p-value was estimated using 2-sided t-test.||0.34|-0.11|0.307
72539558|NCT00038467|144608710|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.07||||0.792|TWO_SIDED|95.0|-0.42|0.56|||t-test, 2 sided|||3 months: p-value was estimated using 2-sided t-test.||0.56|-0.42|0.792
72539559|NCT00038467|144608710|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.23||||0.405|TWO_SIDED|95.0|-0.76|0.31|||t-test, 2 sided|||6 months: p-value was estimated using 2-sided t-test.||0.31|-0.76|0.405
72539560|NCT00038467|144608710|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2||||0.484|TWO_SIDED|95.0|-0.75|0.36|||t-test, 2 sided|||9 months: p-value was estimated using 2-sided t-test.||0.36|-0.75|0.484
72539561|NCT00038467|144608710|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3||||0.229|TWO_SIDED|95.0|-0.19|0.8|||t-test, 2 sided|||12 months: p-value was estimated using 2-sided t-test.||0.80|-0.19|0.229
72539562|NCT00038467|144608710|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.26||||0.381|TWO_SIDED|95.0|-0.84|0.32|||t-test, 2 sided|||18 months: p-value was estimated using 2-sided t-test.||0.32|-0.84|0.381
72539563|NCT00038467|144608710|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.24||||0.405|TWO_SIDED|95.0|-0.82|0.33|||t-test, 2 sided|||24 months: p-value was estimated using 2-sided t-test.||0.33|-0.82|0.405
72539564|NCT00038467|144608711|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.14||||0.648|TWO_SIDED|95.0|-0.77|0.48|||t-test, 2 sided|||3 months: p-value was estimated using 2-sided t-test.||0.48|-0.77|0.648
72539565|NCT00038467|144608711|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.34||||0.366|TWO_SIDED|95.0|-1.08|0.4|||t-test, 2 sided|||6 months: p-value was estimated using 2-sided t-test.||0.40|-1.08|0.366
72539566|NCT00038467|144608711|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.65||||0.062|TWO_SIDED|95.0|-1.33|0.03|||t-test, 2 sided|||9 months: p-value was estimated using 2-sided t-test.||0.03|-1.33|0.062
72539567|NCT00038467|144608711|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.24||||0.545|TWO_SIDED|95.0|-0.53|1.0|||t-test, 2 sided|||12 months: p-value was estimated using 2-sided t-test.||1.00|-0.53|0.545
72539568|NCT00038467|144608711|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.03||||0.932|TWO_SIDED|95.0|-0.77|0.7|||t-test, 2 sided|||18 months: p-value was estimated using 2-sided t-test.||0.70|-0.77|0.932
72539569|NCT00038467|144608711|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.46||||0.244|TWO_SIDED|95.0|-1.24|0.32|||t-test, 2 sided|||24 months: p-value was estimated using 2-sided t-test.||0.32|-1.24|0.244
72539570|NCT00038467|144608712|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.05||||0.876|TWO_SIDED|95.0|-0.62|0.73|||t-test, 2 sided|||3 months: p-value was estimated using 2-sided t-test.||0.73|-0.62|0.876
72539571|NCT00038467|144608712|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5||||0.195|TWO_SIDED|95.0|-1.25|0.26|||t-test, 2 sided|||6 months: p-value was estimated using 2-sided t-test.||0.26|-1.25|0.195
72539572|NCT00038467|144608712|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.18||||0.63|TWO_SIDED|95.0|-0.92|0.55|||t-test, 2 sided|||9 months: p-value was estimated using 2-sided t-test.||0.55|-0.92|0.630
72539573|NCT00038467|144608712|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.24||||0.53|TWO_SIDED|95.0|-0.5|0.98|||t-test, 2 sided|||12 months: p-value was estimated using 2-sided t-test.||0.98|-0.50|0.530
72539574|NCT00038467|144608712|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.61||||0.147|TWO_SIDED|95.0|-1.43|0.21|||t-test, 2 sided|||18 months: p-value was estimated using 2-sided t-test.||0.21|-1.43|0.147
72539575|NCT00038467|144608712|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.36||||0.389|TWO_SIDED|95.0|-1.18|0.46|||t-test, 2 sided|||24 months: p-value was estimated using 2-sided t-test.||0.46|-1.18|0.389
72539576|NCT00038467|144608714|SUPERIORITY_OR_OTHER|||||||0.0174|TWO_SIDED||||||Chi-squared|||6 months: p-value for percentage of participants with an endometrial thickness of \>=5 mm was analyzed using Chi-squared test.||||0.0174
72539577|NCT00038467|144608714|SUPERIORITY_OR_OTHER|||||||0.0059|TWO_SIDED||||||Chi-squared|||12 months: p-value for percentage of participants with an endometrial thickness of \>=5 mm was analyzed using Chi-squared test.||||0.0059
72539578|NCT00038467|144608714|SUPERIORITY_OR_OTHER|||||||0.0037|TWO_SIDED||||||Chi-squared|||24 months: p-value for percentage of participants with an endometrial thickness of \>=5 mm was analyzed using Chi-squared test.||||0.0037
72539579|NCT00038467|144608714|SUPERIORITY_OR_OTHER|||||||0.8084|TWO_SIDED||||||Chi-squared|||12 months post-treatment: p-value for percentage of participants with an endometrial thickness of \>=5 mm was analyzed using Chi-squared test.||||0.8084
72539580|NCT00038467|144608714|SUPERIORITY_OR_OTHER|||||||0.6449|TWO_SIDED||||||Chi-squared|||24 months post-treatment: p-value for percentage of participants with an endometrial thickness of \>=5 mm was analyzed using Chi-squared test.||||0.6449
72539581|NCT01988493|144608722|EQUIVALENCE|Sample size required 100 TTP events to ensure 80% power with a two-sided significance level of 10% for rejecting the null hypothesis of equal treatment effect between treatment arms.|Hazard Ratio (HR)|0.46||||0.0087|TWO_SIDED|90.0|0.28|0.76|||Log Rank|||||0.76|0.28|0.0087
72539582|NCT01988493|144608723|EQUIVALENCE|Sample size required 100 TTP events to ensure 80% power with a two-sided significance level of 10% for rejecting the null hypothesis of equal treatment effect between treatment arms.|Hazard Ratio (HR)|0.53||||0.0229||90.0|0.33|0.84|||Log Rank|||||0.84|0.33|0.0229
72539583|NCT01988493|144608724|EQUIVALENCE|Sample size required 100 TTP events to ensure 80% power with a two-sided significance level of 10% for rejecting the null hypothesis of equal treatment effect between treatment arms.|Hazard Ratio (HR)|0.71||||0.2333||90.0|0.45|1.14|||Log Rank|||||1.14|0.45|0.2333
72539584|NCT01988493|144608725|EQUIVALENCE|Sample size required 100 TTP events to ensure 80% power with a two-sided significance level of 10% for rejecting the null hypothesis of equal treatment effect between treatment arms.|Hazard Ratio (HR)|0.45||||0.0059||90.0|0.28|0.73|||Log Rank|||||0.73|0.28|0.0059
72539585|NCT01988493|144608738|EQUIVALENCE|Sample size required 100 TTP events to ensure 80% power with a two-sided significance level of 10% for rejecting the null hypothesis of equal treatment effect between treatment arms.|Hazard Ratio (HR)|1.04||||0.8915||90.0|0.62|1.77|||Log Rank|||||1.77|0.62|0.8915
72539586|NCT01988493|144608739|EQUIVALENCE|Sample size required 100 TTP events to ensure 80% power with a two-sided significance level of 10% for rejecting the null hypothesis of equal treatment effect between treatment arms.||||||0.0438|||||||Cochran-Mantel-Haenszel|||||||0.0438
72539587|NCT01988493|144608741|EQUIVALENCE|Sample size required 100 TTP events to ensure 80% power with a two-sided significance level of 10% for rejecting the null hypothesis of equal treatment effect between treatment arms.|Hazard Ratio (HR)|0.59||||0.0496|TWO_SIDED|90.0|0.38|0.92|||Log Rank|||||0.92|0.38|0.0496
72539588|NCT01988493|144608742|EQUIVALENCE|Sample size required 100 TTP events to ensure 80% power with a two-sided significance level of 10% for rejecting the null hypothesis of equal treatment effect between treatment arms.||||||0.0527|||||||Cochran-Mantel-Haenszel|||||||0.0527
72539589|NCT02617446|144608787|SUPERIORITY||Mean Difference (Final Values)|-3.0||||0.029|TWO_SIDED|95.0|-5.68|-0.32||Alpha set at 0.05.|ANOVA|Treatment term included in the model||Null hypothesis: No difference in E/Ea ratio between istaroxime and placebo||-0.32|-5.68|0.029
72539590|NCT02617446|144608787|SUPERIORITY||Mean Difference (Final Values)|-2.08||||0.009|TWO_SIDED|95.0|-3.61|-0.55||Alpha set at 0.05.|ANOVA|Treatment term included in the model||Null hypothesis: No difference in E/Ea ratio between istaroxime and placebo||-0.55|-3.61|0.009
72539591|NCT02617446|144608788|SUPERIORITY||Mean Difference (Final Values)|1.7632||||0.089|TWO_SIDED|95.0|-0.2751|3.8014||Alpha set at 0.05. No adjustment for multiple comparisons|ANOVA|Treatment term included in the model||Null hypothesis: No difference in LVEF % between istaroxime and placebo participants.||3.8014|-0.2751|0.089
72539592|NCT02617446|144608788|SUPERIORITY||Mean Difference (Final Values)|0.9848||||0.423|TWO_SIDED|95.0|-1.4668|3.4365||Alpha set at 0.05. No adjustment for multiple comparisons|ANOVA|Treatment term included in the model||Null hypothesis: No difference in LVEF % between istaroxime and placebo participants.||3.4365|-1.4668|0.423
72539593|NCT02617446|144608789|SUPERIORITY||Mean Difference (Final Values)|3.684||||0.034|TWO_SIDED|95.0|0.285|7.083||Alpha set at 0.05. No adjustment for multiple comparisons|ANOVA|Treatment term is in the model.||Null hypothesis: No difference in SVI between istaroxime and placebo participants.||7.083|0.285|0.034
72539594|NCT02617446|144608789|SUPERIORITY||Mean Difference (Final Values)|2.31||||0.09|TWO_SIDED|95.0|-0.373|4.992||Alpha set at 0.05. No adjustment for multiple comparisons|ANOVA|Treatment term is in the model||Null hypothesis: No difference in E to A ratio between istaroxime and placebo participants.||4.992|-0.373|0.090
72539595|NCT02617446|144608790|SUPERIORITY||Mean Difference (Final Values)|-0.777||||0.042|TWO_SIDED|95.0|-1.522|-0.032||Alpha set at 0.05. No adjustment for multiple comparisons|ANOVA|Treatment term is included in the model||Null hypothesis: No difference in E to A ratio between istaroxime and placebo participants.||-0.032|-1.522|0.042
72539596|NCT02617446|144608790|SUPERIORITY||Mean Difference (Final Values)|-0.829||||0.029|TWO_SIDED|95.0|-1.568|-0.091||Alpha set at 0.05. No adjustment for multiple comparisons|ANOVA|Treatment term is in the model||Null hypothesis: No difference in E to A ratio between istaroxime and placebo participants.||-0.091|-1.568|0.029
72539597|NCT02617446|144608791|SUPERIORITY||Mean Difference (Final Values)|-5.368||||0.11|TWO_SIDED|95.0|-11.999|1.262||Alpha set at 0.05. No adjustment for multiple comparisons|ANOVA|Treatment term is in the model||Null hypothesis: No difference in LVESV between istaroxime and placebo participants.||1.262|-11.999|0.110
72539598|NCT02617446|144608791|SUPERIORITY||Mean Difference (Final Values)|0.439||||0.931|TWO_SIDED|95.0|-9.735|10.614||Alpha set at 0.05. No adjustment for multiple comparisons|ANOVA|Treatment term is in the model||Null hypothesis: No difference in LVEDV between istaroxime and placebo participants.||10.614|-9.735|0.931
72539599|NCT02617446|144608792|SUPERIORITY||Mean Difference (Final Values)|-1.657||||0.589|TWO_SIDED|95.0|-7.777|4.461||Alpha set at 0.05. No adjustment for multiple comparisons|ANOVA|Treatment term in the model||Null hypothesis: No difference in E to A ratio between istaroxime and placebo participants.||4.461|-7.777|0.589
72539600|NCT02617446|144608792|SUPERIORITY||Mean Difference (Final Values)|3.944||||0.424|TWO_SIDED|95.0|-5.886|13.774||Alpha set at 0.05. No adjustment for multiple comparisons|ANOVA|Treatment term is in the model.||Null hypothesis: No difference in E to A ratio between istaroxime and placebo participants.||13.774|-5.886|0.424
72539601|NCT02617446|144608793|SUPERIORITY|Linear mixed model with treatment, center, timepoint, gender, baseline cTnT value, atrial fibrillation, and treatment\*timepoint interaction included in the model.|Mean Difference (Final Values)|-0.041||||0.987|TWO_SIDED|95.0|-5.216|5.133||Unadjusted alpha of 0.05 is the threshold for statistical significance.|Mixed Models Analysis|Kenward-Roger adjustment used for the degrees of freedom.||Null hypothesis: no difference between treatment groups||5.133|-5.216|0.987
72539602|NCT02617446|144608793|SUPERIORITY|Linear mixed model with treatment, center, timepoint, gender, baseline cTnT value, atrial fibrillation, and treatment\*timepoint interaction included in the model.|Mean Difference (Final Values)|3.015||||0.251|TWO_SIDED|95.0|-2.168|8.198||Unadjusted alpha of 0.05 is the threshold for statistical significance.|Mixed Models Analysis|Kenward-Roger adjustment used for the degrees of freedom.||Null hypothesis: no difference between treatment groups.||8.198|-2.168|0.251
72542653|NCT01864525|144615271|SUPERIORITY|||||||0.045||||||Statistical results for Magnitude of acoustic frequency tremor. A priori significance threshold was set at P\<0.05 for each of the two hypothesis-driven acoustic variables.|Mixed Models Analysis|This statistical test used the baseline scores as a covariate when comparing post-test scores between placebo and octanoic acid conditions.||Separate measures for magnitude of amplitude tremor and magnitude of frequency tremor were analyzed as these variables can respond differently to treatment and may be differentially affected in essential voice tremor. Statistical modeling tested for post-treatment drug differences, with testing session as a repeated factor. Models were run with and without inclusion of baseline averages as a covariate per recommendations for cross-over treatment studies (Fleiss, Wallenstein \& Rosenfeld, 1985).||||0.0450
72542654|NCT01864525|144615272|SUPERIORITY|||||||0.7172||||||A priori significance was set at P\<0.05 for this hypothesis-driven auditory-perceptual variable. Main effect for drug is given above. For the main task effect, P=0.9602. For the interaction effect of drug\*task, P=0.1699.|Mixed Models Analysis|||Statistical modeling tested for main effects of auditory-perceptual ratings for drug and task (sustained vowel and sentence-level ratings), and interaction effects of these variables. The summed scores, averaged across all participants, are provided separately for the sustained vowel and sentence-level ratings. Values range from 0 (no difference between baseline and post-test) to 3 (all three raters indicated that post-test sample was better (less tremor severity).||||0.7172
72542655|NCT01890785|144615273|SUPERIORITY_OR_OTHER_LEGACY||Ratio of geometric least squares means|0.708|||||TWO_SIDED|90.0|0.655|0.766||||||||0.766|0.655|
72627415|NCT01463527|144783700|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.31|||||TWO_SIDED|95.0|0.17|0.57||||||Odds of intervention in capnography open group as compared to capnography blind group after adjusting of age and length of sedation.||0.57|0.17|
72627416|NCT01463527|144783701|SUPERIORITY|||||||0.3|||||||GEE (Generalized Estimating Equation)|||||||0.30
72539603|NCT00858234|144608910|OTHER|Accumulation Ratio (Day 11 AUC0-24hr/Day 1 AUC0-24hr)|Accumulation ratio|1.08|||||TWO_SIDED|90.0|0.8|1.45|||||Back-transformed least squares mean difference and 90% confidence interval from mixed effects model performed on natural log-transformed values.|||1.45|0.80|
72539604|NCT00529802|144608993|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.9||||0.69|TWO_SIDED|95.0|-9.3|13.23|||t-test, 2 sided|Relative changes in tumor size were log-transformed to satisfy the normality assumption for the t-test.|Mean difference is the difference between Low and High SUV uptake groups in tumor size percent (%) change from baseline, and is reported on the raw scale. Tumor size changes were log-transformed for the t-test.|Relative changes in tumor size were log-transformed to satisfy the normality assumption.||13.23|-9.3|0.69
72539605|NCT00529802|144608994|SUPERIORITY_OR_OTHER||Slope|0.0028|STANDARD_ERROR_OF_MEAN|0.00109||0.013|TWO_SIDED|95.0|0.00063|0.004997|||Regression, Linear|Tumor size change (outcome variable) was log-transformed to satisfy the normality assumption.|Outcome was log(tumor size at 8 weeks/tumor size at baseline), and the predictor was the early change in aveSUVmax \[(aveSUVmax at 2 weeks - aveSUVmax at baseline)/aveSUVmax at baseline\] x 100%.|The relationship between early changes in SUV uptake (from baseline to 2 weeks) and tumor size changes (from baseline to 8 weeks) were examined using linear regression models. Tumor size change was log-transformed to satisfy the normality assumption.||0.004997|0.00063|0.013
72539606|NCT01336608|144608995|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.01||||0.969|TWO_SIDED|95.0|-0.71|0.74|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM)||||0.74|-0.71|0.969
72539607|NCT01336608|144608995|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.22||||0.568|TWO_SIDED|95.0|-0.53|0.96|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM)||||0.96|-0.53|0.568
72539608|NCT01336608|144608995|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.2||||0.566|TWO_SIDED|95.0|-0.49|0.89|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM)||||0.89|-0.49|0.566
72539609|NCT01336608|144608996|SUPERIORITY_OR_OTHER||Least squares mean difference|0.082||||0.007|TWO_SIDED|95.0|0.023|0.141||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).||||0.141|0.023|0.007
72539610|NCT01336608|144608996|SUPERIORITY_OR_OTHER||Least squares mean difference|0.155|||<|0.001|TWO_SIDED|95.0|0.095|0.215||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).||||0.215|0.095|<0.001
72539611|NCT01336608|144608996|SUPERIORITY_OR_OTHER||Least squares mean difference|0.074||||0.012|TWO_SIDED|95.0|0.016|0.131||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).||||0.131|0.016|0.012
72539612|NCT01336608|144608997|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.47|||<|0.001|TWO_SIDED|95.0|-0.72|-0.22||Nominal p-value|ANCOVA|||||-0.22|-0.72|<0.001
72539613|NCT01336608|144608997|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.5|||<|0.001|TWO_SIDED|95.0|-0.76|-0.24||Nominal p-value|ANCOVA|||||-0.24|-0.76|<0.001
72539614|NCT01336608|144608997|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.03||||0.803|TWO_SIDED|95.0|-0.29|0.22|||ANCOVA|||||0.22|-0.29|0.803
72539615|NCT00080288|144608998|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.7|||<|0.0001||95.0|1.67|3.69|||ANCOVA|||Assumption: both primary treatment comparisons would be with a 2 sided test at an alpha level of 0.05.||3.69|1.67|<0.0001
72539616|NCT00080288|144608999|SUPERIORITY_OR_OTHER|||||||0.001|||||||Cochran-Mantel-Haenszel|The p value for each treatment group is for the comparison of that treatment group to the placebo treatment group. Adjusted for country.||Assumption: both primary treatment comparisons would be with a 2 sided test at an alpha level of 0.05.||||0.0010
72539617|NCT01143272|144609048|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.02||||0.94|TWO_SIDED|95.0|0.55|1.9|||Regression, Cox|||||1.90|0.55|0.94
72539618|NCT01143272|144609048|SUPERIORITY_OR_OTHER|||||||0.25|||||||Fisher Exact|||||||0.25
72539619|NCT01143272|144609048|SUPERIORITY_OR_OTHER|||||||0.87|||||||Log Rank|||||||0.87
72539620|NCT01143272|144609050|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.92||||0.8|TWO_SIDED|95.0|0.49|1.73|||Regression, Cox|||||1.73|0.49|0.80
72539621|NCT01143272|144609050|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.03||||0.93|TWO_SIDED|95.0|0.53|2.03||adjusting for age, sex, CRP, leukocyte count, duration of antibiotic treatment, and administration of antibiotics|Regression, Cox|||||2.03|0.53|0.93
72539622|NCT01143272|144609051|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.02||||0.6|TWO_SIDED|95.0|0.96|1.08||Association between initial leukocyte count and incidence of AAD|Regression, Logistic|||||1.08|0.96|0.6
72539623|NCT01143272|144609051|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.0||||0.653|TWO_SIDED|95.0|1.0|1.01||Association between the initial C-reactive protein and incidence of AAD|Regression, Logistic|||||1.01|1.00|0.653
72539624|NCT00545181|144609068|SUPERIORITY_OR_OTHER|||||||0.75||95.0|||||Chi-squared, Corrected|||||||0.75
72539625|NCT01818414|144609095|SUPERIORITY_OR_OTHER|||||||0.17|||||||t-test, 2 sided|||||||0.17
72539626|NCT01818414|144609096|SUPERIORITY_OR_OTHER|||||||0.052|||||||t-test, 2 sided|||||||0.052
72539627|NCT03870737|144609100|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|Time: F = 24.81, df = 1/40.||Outcomes fitted via a mixed effects model with time as predictor.||||<.0001
72627417|NCT01788943|144783702|OTHER|||||||0.037|||||||ANOVA|||||||0.037
72627418|NCT01788943|144783703|OTHER|||||||0.01|||||||t-test, 2 sided|||||||0.01
72627419|NCT01448616|144783750|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.86||||0.086|TWO_SIDED|95.0|0.71|1.01||ITT|Poisson GLME|||For intent to treat analysis, difference between lead-in and treatment phase (within arm comparison)||1.01|0.71|0.086
72627420|NCT01448616|144783750|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.94||||0.54|TWO_SIDED|95.0|0.75|1.16||For intent to treat analysis, difference between lead-in and treatment phase (within arm comparison)|Poisson GLME|||For intent to treat analysis, difference between lead-in and treatment phase (within arm comparison)||1.16|0.75|0.54
72539628|NCT03870737|144609102|SUPERIORITY|||||||0.02|||||||Mixed Models Analysis|Time: F = 5.78, df = 1/39.||Outcome was fitted using a mixed model with time as predictor.||||.02
72539629|NCT03870737|144609103|SUPERIORITY|||||||0.0005|||||||Mixed Models Analysis|Time: F = 14.28, df = 1/39.||Outcome was fitted using a mixed model with time as predictor.||||.0005
72539630|NCT03870737|144609104|SUPERIORITY|||||||0.67|||||||Mixed Models Analysis|Time: F = .19, df = 1/39.||Outcome was fitted using a mixed model with time as predictor.||||.67
72539631|NCT03870737|144609105|SUPERIORITY|||||||0.76|||||||Mixed Models Analysis|Time: F = .08, df = 1/39.||Outcome was fitted using a mixed model with time as predictor.||||.76
72539632|NCT03870737|144609106|SUPERIORITY|||||||0.8|||||||Mixed Models Analysis|Time: F = .06, df = 1/39.||Outcome was fitted using a mixed model with time as predictor.||||.80
72539633|NCT01227954|144609148|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||To detect a minimum relative 50% improvement leading to an absolute 15% mean relative decline (MRD) in HVLT-R DR, 51 analyzable patients were required to ensure 80% statistical power with 0.05 alpha. Assuming a death rate of 40% before 4 months (based on trial NCT00003563) and a 10% nonevaluable rate, the target sample size was 102. The target MRD was determined from NCT00003563 which demonstrated 30% MRD in HVLT-R DR score from baseline to 4 months, with a standard deviation of 41%.||||<0.001
72539634|NCT01227954|144609151|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|Each explanatory variable in the final model is reported separately.||A general linear fixed effects model was run with FACT-Br total score (baseline, 2, 4, 6 mo. from end of treatment) as outcome of interest. Explanatory variables: Age (\>= 60 vs. \<60), primary site (lung,breast,colon each vs. other), neurologic function status (no vs. some symptoms), and recursive partitioning analysis class (RPA) (I vs. II). Explanatory variables are reported separately and only if in the final model (p\< 0.10, except time forced in the model.). Intercept is reported here.||||<0.0001
72539635|NCT01227954|144609151|SUPERIORITY|||||||0.1961|||||||Mixed Models Analysis|Each explanatory variable in the final model is reported separately.||A general linear fixed effects model was run with FACT-Br total score (baseline, 2, 4, 6 mo. from end of treatment) as outcome of interest. Explanatory variables in the model: Age (\>= 60 vs. \<60), primary site (lung,breast,colon each vs. other), neurologic function status (no vs. some symptoms), and RPA class(I vs. II). Explanatory variables are reported separately and only if they are in the final model (p\< 0.10, except time forced in the model.). Time is reported here.||||0.1961
72539636|NCT01227954|144609151|SUPERIORITY|||||||0.0715|||||||Mixed Models Analysis|Each explanatory variable in the final model is reported separately.||A general linear fixed effects model was run with FACT-Br total score (baseline, 2, 4, 6 mo. from end of treatment) as outcome of interest. Explanatory variables in the model: Age (\>= 60 vs. \<60), primary site (lung,breast,colon each vs. other), neurologic function status (no vs. some symptoms), and RPA class(I vs. II). Explanatory variables are reported separately and only if they are in the final model (p\< 0.10, except time forced in the model.). Primary site (lung) is reported here.||||0.0715
72539637|NCT01227954|144609151|SUPERIORITY|||||||0.0554|||||||Mixed Models Analysis|Each explanatory variable in the final model is reported separately.||A general linear fixed effects model with FACT-Br total score (baseline, 2, 4, 6 mo. from end of treatment) as outcome of interest. Explanatory variables in the model: Age (\>= 60 vs. \<60), primary site (lung,breast,colon each vs. other), neurologic function status (no vs. some symptoms), and RPA class(I vs. II). Explanatory variables are reported separately and only if they are in the final model (p\< 0.10, except time forced in the model.). Neurologic status (no symptoms) is reported here.||||0.0554
72539638|NCT01227954|144609152|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|Each explanatory variable in the final model is reported separately.||A general linear fixed effects model was run with ADL (baseline, 2, 4, 6 mo. from end of treatment) as outcome of interest. Explanatory variables in the model: Age (\>= 60 vs. \<60), primary site (lung,breast,colon each vs. other), neurologic function status (no vs. some symptoms), and RPA class(I vs. II). Explanatory variables are reported separately and only if they are in the final model (p\< 0.10, except time forced in the model.). Intercept is reported here.||||<0.0001
72539639|NCT01227954|144609152|SUPERIORITY|||||||0.1579|||||||Mixed Models Analysis|Each explanatory variable in the final model is reported separately.||A general linear fixed effects model was run with ADL (baseline, 2, 4, 6 mo. from end of treatment) as outcome of interest. Explanatory variables in the model: Age (\>= 60 vs. \<60), primary site (lung,breast,colon each vs. other), neurologic function status (no vs. some symptoms), and RPA class(I vs. II). Explanatory variables are reported separately and only if they are in the final model (p\< 0.10, except time forced in the model.). Time is reported here.||||0.1579
72539640|NCT01227954|144609152|SUPERIORITY|||||||0.0559|||||||Mixed Models Analysis|Each explanatory variable in the final model is reported separately.||A general linear fixed effects model was run with ADL (baseline, 2, 4, 6 mo. from end of treatment) as outcome of interest. Explanatory variables in the model: Age (\>= 60 vs. \<60), primary site (lung,breast,colon each vs. other), neurologic function status (no vs. some symptoms), and RPA class(I vs. II). Explanatory variables are reported separately and only if they are in the final model (p\< 0.10, except time forced in the model.). Neurologic function status (some symptoms) is reported here.||||0.0559
72539641|NCT01227954|144609152|SUPERIORITY|||||||0.0749|||||||Mixed Models Analysis|Each explanatory variable in the final model is reported separately.||A general linear fixed effects model was run with ADL (baseline, 2, 4, 6 mo. from end of treatment) as outcome of interest. Explanatory variables in the model: Age (\>= 60 vs. \<60), primary site (lung,breast,colon each vs. other), neurologic function status (no vs. some symptoms), and RPA class(I vs. II). Explanatory variables are reported separately and only if they are in the final model (p\< 0.10, except time forced in the model.). Age (\>= 60) is reported here.||||0.0749
72539642|NCT03583931|144609158|SUPERIORITY|||||||0.61|||||||ANOVA|||||||0.61
72539643|NCT03583931|144609159|SUPERIORITY|||||||0.84|||||||ANOVA|||||||0.84
72539644|NCT03583931|144609164|SUPERIORITY|||||||0.48|||||||ANOVA|||||||0.48
72539645|NCT03583931|144609165|SUPERIORITY|||||||0.25|||||||ANOVA|||||||0.25
72539646|NCT03583931|144609166|SUPERIORITY|||||||0.45|||||||ANOVA|||||||0.45
72539647|NCT03583931|144609167|SUPERIORITY|||||||0.87|||||||ANOVA|||||||0.87
72539648|NCT02787785|144609169|SUPERIORITY||Cox Proportional Hazard|0.49||||0.354|TWO_SIDED|95.0|0.11|2.2|||Regression, Cox|||||2.20|0.11|0.354
72627421|NCT01448616|144783750|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.9||||0.47|TWO_SIDED|95.0|0.67|1.22|||Poisson GLME|||For intent to treat analysis, difference between lead-in and treatment phase (within arm comparison)||1.22|0.67|0.47
72627422|NCT01448616|144783751|SUPERIORITY_OR_OTHER_LEGACY||Change in log copies|-0.16||||0.18|TWO_SIDED|95.0|-0.4|0.07|||Linear Mixed Effects Model|||Intent to treat analysis||0.07|-0.40|0.18
72539649|NCT02787785|144609171|SUPERIORITY||Cox Proportional Hazard|0.37||||0.479|TWO_SIDED|95.0|0.02|5.88|||Regression, Cox|||||5.88|0.02|0.479
72539650|NCT00535301|144609244|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.24|STANDARD_DEVIATION|2.0||0.005|TWO_SIDED|95.0|0.1|0.6|||Chi-squared|||Sample size was calculated based on previously-published anatomic success rates of standard anterior colporrhaphy (50%) and polypropylene mesh-reinforced anterior vaginal repair (85%) (1-10). Assuming a 2-sided hypothesis test with 5% type I error and 80% power, 33 patients in each group would be required to detect an absolute difference of 35% or more in recurrent stage II prolapse. Assuming a 15% drop-out rate, we sought to enroll 76 patients into the clinical trial.||0.6|0.1|0.005
72539651|NCT00535301|144609245|SUPERIORITY_OR_OTHER|||||||0.5||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.5
72539652|NCT00535301|144609246|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Fisher Exact|||||||<0.05
72539653|NCT05144477|144609262|OTHER|Proportion of referrals who provided consent and enrolled into the study was calculated.|Proportion|0.64|||||TWO_SIDED|95.0|0.425|0.82||||||||0.820|0.425|
72539654|NCT05144477|144609263|OTHER|Proportion of enrolled participants who remained in the study at 30 days after the end of hospital care was calculated.|Proportion|0.875|||||TWO_SIDED|95.0|0.617|0.985||||||||0.985|0.617|
72539655|NCT05144477|144609264|OTHER|Proportion of participants randomized to the FAID Fear Diary Intervention who wrote in the diary at least twice per week up until the end of hospital care was calculated.|Proportion|0.636|||||TWO_SIDED|95.0|0.308|0.891||||||||0.891|0.308|
72539656|NCT05144477|144609265|OTHER|Proportion of enrolled participants who provided complete data for at least 90% of all study assessments was calculated.|Proportion|0.875|||||TWO_SIDED|95.0|0.617|0.985||||||||0.985|0.617|
72539657|NCT05144477|144609266|OTHER|Proportion of intervention participants who agreed that the ICU diary was acceptable for reducing fear about their loved one's heart was calculated.|Proportion|0.8|||||TWO_SIDED|95.0|0.444|0.975||||||||0.975|0.444|
72539658|NCT05144477|144609267|OTHER|Proportion of intervention participants who agreed that the ICU diary was feasible for reducing fear about their loved one's heart was calculated.|Proportion|0.9|||||TWO_SIDED|95.0|0.555|0.998||||||||0.998|0.555|
72539659|NCT05144477|144609268|OTHER|Proportion of intervention participants who agreed that the ICU diary was appropriate for reducing fear about their loved one's heart was calculated.|Proportion|0.7|||||TWO_SIDED|95.0|0.348|0.933||||||||0.933|0.348|
72539660|NCT05144477|144609269|SUPERIORITY||Mean Difference (Final Values)|0.24||||0.63|TWO_SIDED|95.0|-0.83|1.32|||t-test, 2 sided|||Outcome analysis at the end of hospital care.||1.32|-0.83|.63
72539661|NCT05144477|144609269|SUPERIORITY||Mean Difference (Final Values)|0.08||||0.86|TWO_SIDED|95.0|-0.92|1.08|||t-test, 2 sided|||Outcome analysis for 30 days after the end of hospital care.||1.08|-0.92|.86
72539662|NCT05144477|144609270|SUPERIORITY||Mean Difference (Final Values)|-0.11||||0.86|TWO_SIDED|95.0|-1.43|1.21|||t-test, 2 sided|||Outcome analysis for the end of hospital care.||1.21|-1.43|.86
72539663|NCT05144477|144609270|SUPERIORITY||Mean Difference (Final Values)|0.19||||0.75|TWO_SIDED|95.0|-1.1|1.58|||t-test, 2 sided|||Outcome analysis for 30 days after the end of hospital care.||1.58|-1.10|.75
72539664|NCT05144477|144609271|SUPERIORITY||Mean Difference (Final Values)|-8.7||||0.22|TWO_SIDED|95.0|-23.26|5.86|||t-test, 2 sided|||||5.86|-23.26|.22
72539665|NCT05144477|144609271|SUPERIORITY|||||||0.26|||||||Wilcoxon (Mann-Whitney)||||χ2(1) = 1.29|||.26
72539666|NCT05144477|144609271|SUPERIORITY|||||||1|||||||Fisher Exact|||A Fisher's Exact Test was conducted to compare the number of participants with a positive screen for PTSD symptoms (score \>=33) to those who did not have a positive screen for PTSD symptoms (score \< 33).||||1.00
72539667|NCT04333199|144609275|SUPERIORITY||Odds Ratio (OR)|2.9903891|||<|0.001|TWO_SIDED|95.0|2.2805876|3.9211066||We used an a priori threshold of p \< .05.|Regression, Logistic|||||3.9211066|2.2805876|<0.001
72539668|NCT04333199|144609276|SUPERIORITY||Odds Ratio (OR)|1.1781659||||0.154|TWO_SIDED|95.0|0.9404654|1.4759445||We used an a priori threshold of p \< .05.|Regression, Logistic|||||1.4759445|0.9404654|0.154
72539669|NCT04333199|144609277|SUPERIORITY||Odds Ratio (OR)|0.9575636||||0.571|TWO_SIDED|95.0|0.8242111|1.1124918||We used an a priori threshold of p \< .05.|Regression, Logistic|||||1.1124918|0.8242111|0.571
72539670|NCT04333199|144609278|SUPERIORITY||Odds Ratio (OR)|1.8562672|||<|0.001|TWO_SIDED|95.0|1.5692523|2.1957769||We used an a priori threshold of p \< .05.|Regression, Logistic|||||2.1957769|1.5692523|<0.001
72539671|NCT04333199|144609280|SUPERIORITY||Odds Ratio (OR)|1.8542767|||<|0.001|TWO_SIDED|95.0|1.5220654|2.2589975||We used an a priori threshold of p \< .05.|Regression, Logistic|||||2.2589975|1.5220654|<0.001
72542656|NCT01890785|144615273|SUPERIORITY_OR_OTHER_LEGACY||Ratio of geometric least squares means|0.918|||||TWO_SIDED|90.0|0.849|0.992||||||||0.992|0.849|
72542657|NCT01890785|144615274|SUPERIORITY_OR_OTHER_LEGACY||Ratio of geometric least squares means|0.641|||||TWO_SIDED|90.0|0.582|0.707||||||||0.707|0.582|
72627423|NCT01448616|144783751|SUPERIORITY_OR_OTHER_LEGACY||Change in log copies|-0.5||||0.008|TWO_SIDED|95.0|-0.86|-0.13|||Linear Mixed Effects Model|||Intent to treat analysis||-0.13|-0.86|0.008
72627424|NCT01448616|144783751|SUPERIORITY_OR_OTHER_LEGACY||Change in log copies|0.16||||0.45|TWO_SIDED|95.0|-0.27|0.6|||Linear Mixed Effects Model|||Intent to treat analysis||0.60|-0.27|0.45
72627425|NCT01448616|144783752|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.98||||0.9|TWO_SIDED|95.0|0.7|1.37|||Poisson GLME|||Intent to treat analysis||1.37|0.70|0.90
72539672|NCT03111407|144609281|EQUIVALENCE|Data analyzed with SAS Enterprise Guided (version 7.15 HF3, SAS lnstitute lnc., Cary, NC). Significance level set with q = 0.05. Continuous data (e.g. age, weight, EQ-5D) were summarized using mean, standard deviation, minimum, median, maximum and number of observations. Comparison between continuous baseline and patient visits were performed using standard statistical tests (e.g., a t-test, Wilcoxon test, or one-way ANOVA (as appropriate) were performed as required to evaluate the difference).||||||0.2342|||||||t-test, 2 sided|||"Hip Knee Angle value 1 year post surgery: Mean+/- SD (N)(Min, Max) 95%C.I (lower, upper)~iAssist group: 179.9 +/-2.9 (44) (171, 185.3)~Conventional group: 178.9 +/-3.9 (26) (167, 185)"||||0.2342
72539673|NCT03111407|144609282|EQUIVALENCE|Data analyzed with SAS Enterprise Guided (version 7.15 HF3, SAS lnstitute lnc., Cary, NC). Significance level set with q = 0.05. Continuous data (e.g. age, weight, EQ-5D) were summarized using mean, standard deviation, minimum, median, maximum and number of observations. Comparison between continuous baseline and patient visits were performed using standard statistical tests (e.g., a t-test, Wilcoxon test, or one-way ANOVA (as appropriate) were performed as required to evaluate the difference).||||||0.4427|||||||t-test, 2 sided|||"Knee Society Score Assessment 1 year post surgery: Mean+/- SD (N)(Min, Max) 95%C.I (lower, upper)~iAssist group: 74.7 +/- 12.5 \[44\] (30.2, 78.0, 89.5), 95% C.I. (70.9, 78.5)~Conventional group: 72.4 +/- 11.6 \[26\] (45.0, 75.2, 90.1), 95% C.I. (67.7, 77.1)"||||0.4427
72539674|NCT03111407|144609283|EQUIVALENCE|Data analyzed with SAS Enterprise Guided (version 7.15 HF3, SAS lnstitute lnc., Cary, NC). Significance level set with q = 0.05. Continuous data (e.g. age, weight, EQ-5D) were summarized using mean, standard deviation, minimum, median, maximum and number of observations. Comparison between continuous baseline and patient visits were performed using standard statistical tests (e.g., a t-test, Wilcoxon test, or one-way ANOVA (as appropriate) were performed as required to evaluate the difference).||||||0.6154|||||||t-test, 2 sided|||Knee Soceity Score Function 1 year post surgery: Mean+/- SD (N)(Min, Max) 95%C.I (lower, upper) iAssist group: 80.5 +/- 13.8 \[44\] (55.0, 80.0, 100.0), 95% C.I. (76.2, 84.7) Conventional group: 78.5 +/- 19.1 \[26\] (40.0, 80.0, 100.0),95% C.I. (70.8, 86.2)||||0.6154
72539675|NCT03111407|144609284|EQUIVALENCE|Data analyzed with SAS Enterprise Guided (version 7.15 HF3, SAS lnstitute lnc., Cary, NC). Significance level set with q = 0.05. Continuous data (e.g. age, weight, EQ-5D) were summarized using mean, standard deviation, minimum, median, maximum and number of observations. Comparison between continuous baseline and patient visits were performed using standard statistical tests (e.g., a t-test, Wilcoxon test, or one-way ANOVA (as appropriate) were performed as required to evaluate the difference).||||||0.4549|||||||t-test, 2 sided|||EQ-5D score 1 year post surgery: Mean+/- SD (N)(Min, Max) 95%C.I (lower, upper) iAssist group: 0.8 +/- 0.2 \[29\] (0.0, 1.0, 1.0), 95% C.I. (0.7, 0.9) Conventional group: 0.8 +/- 0.3 \[20\] (0.1, 0.8, 1.0), 95% C.I. (0.7, 0.9)||||0.4549
72539676|NCT01032330|144609418|SUPERIORITY||Risk Difference (RD)|0.054||||0.004|ONE_SIDED|95.0|0.02||||One-sided Barnard's Test||||||0.020|0.004
72539677|NCT01032330|144609419|OTHER||cumulative probability|0.15|||||TWO_SIDED|95.0|0.1|0.22|||||Kaplan-Meier estimate of cumulative probability of deterioration by 3 years|||.22|.10|
72539678|NCT01032330|144609420|SUPERIORITY||Risk Difference (RD)|0.024||||0.27|TWO_SIDED|95.0|-0.038|0.094|||One-sided Barnard's Test|||||0.094|-0.038|0.27
72539679|NCT01032330|144609422|OTHER||||||<|0.001|||||||ANCOVA|||P-value for the change between baseline and 3 years. Two-sided p values for comparisons of continuous outcomes are from analysis of covariance models adjusting for the baseline level of the outcome.||||<.001
72539680|NCT01032330|144609423|OTHER|||||||0.38|||||||ANCOVA|||Two-sided p values for comparisons of continuous outcomes are from analysis of covariance models adjusting for the baseline level of the outcome; P values for comparisons of binary outcomes are from logistic regression models adjusting for the baseline level of the outcome.||||0.38
72539681|NCT01032330|144609424|OTHER||||||<|0.001|||||||ANCOVA|||P-value for the change between baseline and 3 years. Two-sided p values for comparisons of continuous outcomes are from analysis of covariance models adjusting for the baseline level of the outcome.||||<.001
72539682|NCT01032330|144609425|OTHER|||||||0.09|||||||ANCOVA|||P-value for the change between baseline and 6 months in the Older cohort. Two-sided p values for comparisons of continuous outcomes are from analysis of covariance models adjusting for the baseline level of the outcome.||||0.09
72539683|NCT01032330|144609425|OTHER|||||||0.02|||||||ANCOVA|||P-value for the change between baseline and 6 months in the Younger cohort. Two-sided p values for comparisons of continuous outcomes are from analysis of covariance models adjusting for the baseline level of the outcome.||||0.02
72539684|NCT01032330|144609426|OTHER||||||<|0.001|||||||ANCOVA|||P-value for the change between baseline and 3 Years in the Older cohort. Two-sided p values for comparisons of continuous outcomes are from analysis of covariance models adjusting for the baseline level of the outcome.||||<.001
72539685|NCT01032330|144609426|OTHER|||||||0.33|||||||ANCOVA|||P-value for the change between baseline and 3 Years in the Younger cohort. Two-sided p values for comparisons of continuous outcomes are from analysis of covariance models adjusting for the baseline level of the outcome.||||0.33
72539686|NCT01032330|144609427|OTHER|||||||0.013|||||||ANCOVA|||P-value for the change between baseline and 6 months in the Older cohort. Two-sided p values for comparisons of continuous outcomes are from analysis of covariance models adjusting for the baseline level of the outcome.||||0.013
72539687|NCT01032330|144609427|OTHER|||||||0.26|||||||ANCOVA|||P-value for the change between baseline and 6 months in the Younger cohort. Two-sided p values for comparisons of continuous outcomes are from analysis of covariance models adjusting for the baseline level of the outcome.||||0.26
72575313|NCT01338870|144676546|SUPERIORITY_OR_OTHER||LS mean difference|-0.06|STANDARD_ERROR_OF_MEAN|0.057||0.1568|TWO_SIDED|80.0|-0.13|0.02|||Mixed Models Analysis|||Week 1: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction, baseline-by-treatment interaction, baseline-by-treatment-by-time interaction as the covariates, time was repeated for participant.||0.02|-0.13|0.1568
72575314|NCT01338870|144676546|SUPERIORITY_OR_OTHER||LS mean difference|-0.18|STANDARD_ERROR_OF_MEAN|0.058||0.001|TWO_SIDED|80.0|-0.25|-0.11|||Mixed Models Analysis|||Week 1: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction, baseline-by-treatment interaction, baseline-by-treatment-by-time interaction as the covariates, time was repeated for participant.||-0.11|-0.25|0.0010
72627426|NCT01448616|144783752|SUPERIORITY||Risk Ratio (RR)|0.8||||0.25|TWO_SIDED|95.0|0.54|1.18|||Poisson GLM|||Intent to treat||1.18|0.54|0.25
72539688|NCT01032330|144609428|OTHER|||||||0.42|||||||ANCOVA|||P-value for the change between baseline and 3 Years in the Older cohort. Two-sided p values for comparisons of continuous outcomes are from analysis of covariance models adjusting for the baseline level of the outcome.||||0.42
72539689|NCT01032330|144609428|OTHER|||||||0.61|||||||ANCOVA|||P-value for the change between baseline and 3 Years in the Younger cohort. Two-sided p values for comparisons of continuous outcomes are from analysis of covariance models adjusting for the baseline level of the outcome.||||0.61
72539690|NCT01032330|144609429|OTHER|||||||0.012|||||||ANCOVA|||P-value for the change between baseline and 6 months in the Older cohort. Two-sided p values for comparisons of continuous outcomes are from analysis of covariance models adjusting for the baseline level of the outcome.||||0.012
72539691|NCT01032330|144609429|OTHER|||||||0.02|||||||ANCOVA|||P-value for the change between baseline and 6 months in the Younger cohort. Two-sided p values for comparisons of continuous outcomes are from analysis of covariance models adjusting for the baseline level of the outcome.||||0.02
72539692|NCT01032330|144609430|OTHER|||||||0.002|||||||ANCOVA|||P-value for the change between baseline and 3 Years in the Older cohort. Two-sided p values for comparisons of continuous outcomes are from analysis of covariance models adjusting for the baseline level of the outcome.||||.002
72539693|NCT01032330|144609430|OTHER|||||||0.01|||||||ANCOVA|||P-value for the change between baseline and 3 Years in the Younger cohort. Two-sided p values for comparisons of continuous outcomes are from analysis of covariance models adjusting for the baseline level of the outcome.||||0.01
72539694|NCT01032330|144609431|OTHER|||||||0.11|||||||ANCOVA|||P-value for the change between baseline and 6 months in the Older cohort. Two-sided p values for comparisons of continuous outcomes are from analysis of covariance models adjusting for the baseline level of the outcome.||||0.11
72539695|NCT01032330|144609431|OTHER|||||||0.1|||||||ANCOVA|||P-value for the change between baseline and 6 months in the Younger cohort. Two-sided p values for comparisons of continuous outcomes are from analysis of covariance models adjusting for the baseline level of the outcome.||||0.10
72539696|NCT01032330|144609432|OTHER|||||||0.6|||||||ANCOVA|||P-value for the change between baseline and 3 Years in the Older cohort. Two-sided p values for comparisons of continuous outcomes are from analysis of covariance models adjusting for the baseline level of the outcome.||||0.60
72539697|NCT01032330|144609432|OTHER|||||||0.09|||||||ANCOVA|||P-value for the change between baseline and 3 Years in the Younger cohort. Two-sided p values for comparisons of continuous outcomes are from analysis of covariance models adjusting for the baseline level of the outcome.||||0.09
72539698|NCT02268045|144609433|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The RR, with the corresponding 95% CI, was calculated for each treatment arm and compared using Fisher's exact test at a one-sided 0.025 type I error rate. A non-inferiority margin of 13% was assumed with ≥ 80% power to detect treatment differences. Non-inferiority was concluded if the one-sided 95% CI was above the -13% margin set for the study.|Percentage difference|0.7|||||ONE_SIDED|95.0|-13.0||||||For the ITT population||||-13|
72539699|NCT02268045|144609433|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The RR, with the corresponding 95% CI, was calculated for each treatment arm and compared using Fisher's exact test at a one-sided 0.025 type I error rate. A non-inferiority margin of 13% was assumed with ≥ 80% power to detect treatment differences. Non-inferiority was concluded if the one-sided 95% CI was above the -13% margin set for the study.|percentage difference|3.0|||||ONE_SIDED|95.0|-13.0||||||For the PP population||||-13|
72539700|NCT02268045|144609434|EQUIVALENCE|Two treatments are judged not to be different from one another if the 90% CI of the ratio of a log-transformed exposure measure (AUC) falls completely within the range 80%-125%.|ratio RTXM83 to Mabthera|99.2|||||TWO_SIDED|90.0|93.6|105.0|||||For the ratio: RTXM83 represents the numerator and Mabthera the denominator|||105|93.6|
72539701|NCT02268045|144609435|EQUIVALENCE|Two treatments are judged not to be different from one another if the 90% CI of the ratio of a log-transformed exposure measure (AUC) falls completely within the range 80%-125%.|ratio RTXM83 to Mabthera|103.0|||||TWO_SIDED|90.0|98.5|107.0|||||For the ratio: RTXM83 represents the numerator and Mabthera the denominator|||107|98.5|
72539702|NCT02268045|144609436|EQUIVALENCE|Two treatments are judged not to be different from one another if the 90% CI of the ratio of a log-transformed exposure measure (AUC) falls completely within the range 80%-125%.|ratio RTXM83 to Mabthera|99.6|||||TWO_SIDED|90.0|93.9|105.0|||||For the ratio: RTXM83 represents the numerator and Mabthera the denominator|||105|93.9|
72542658|NCT01890785|144615274|SUPERIORITY_OR_OTHER_LEGACY||Ratio of geometric least squares means|0.828|||||TWO_SIDED|90.0|0.752|0.912||||||||0.912|0.752|
72542659|NCT01890785|144615275|SUPERIORITY_OR_OTHER_LEGACY||Ratio of geometric least squares means|0.97|||||TWO_SIDED|90.0|0.937|1.004||||||||1.004|0.937|
72627427|NCT01448616|144783752|SUPERIORITY||Risk Ratio (RR)|0.95||||0.82|TWO_SIDED|95.0|0.57|1.57|||Poisson GLM|||||1.57|0.57|0.82
72539703|NCT02268045|144609437|EQUIVALENCE|Two treatments are judged not to be different from one another if the 90% CI of the ratio of a log-transformed exposure measure (AUC) falls completely within the range 80%-125%.|ratio RTXM83 to Mabthera|104.0|||||TWO_SIDED|90.0|99.5|109.0|||||For the ratio: RTXM83 represents the numerator and Mabthera the denominator|||109|99.5|
72539704|NCT02268045|144609441|OTHER|||||||0.457|||||||Log Rank|||||||0.4570
72539705|NCT01766310|144609442|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.68|STANDARD_DEVIATION|1.3||0.05|TWO_SIDED|95.0|-0.09|1.44|||t-test, 2 sided|||||1.44|-0.09|0.05
72539706|NCT01154673|144609446|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2||||0.056|TWO_SIDED|95.0|-0.006|0.4||"The estimated difference in mean change from baseline to 48 weeks was calculated as the log DNA copies/106 CD4+ T cells in Intensive HAART minus the log DNA copies/106 CD4+ T cells in Placebo Arm"|Regression, Linear||"The estimated difference in mean change from baseline to 48 weeks was calculated as the log DNA copies/106 CD4+ T cells in Intensive HAART minus the log DNA copies/106 CD4+ T cells in Placebo Arm"|||0.4|-.006|0.056
72539707|NCT01556490|144609448|SUPERIORITY||Hazard Ratio (HR)|1.08||||0.4552|TWO_SIDED|95.0|0.89|1.31|||Log Rank|||||1.31|0.89|0.4552
72539708|NCT01556490|144609449|SUPERIORITY||Hazard Ratio (HR)|0.78||||0.0626|TWO_SIDED|95.0|0.61|1.01|||Log Rank|||||1.01|0.61|0.0626
72539709|NCT01556490|144609450|SUPERIORITY||Hazard Ratio (HR)|0.76||||0.0227|TWO_SIDED|95.0|0.59|0.96|||Log Rank|||||.96|.59|0.0227
72539710|NCT01556490|144609451|SUPERIORITY||Hazard Ratio (HR)|0.68||||0.0043|TWO_SIDED|95.0|0.52|0.89|||Log Rank|||||.89|.52|0.0043
72539711|NCT01556490|144609452|SUPERIORITY||Mean Difference (Final Values)|15.5||||0.0001|TWO_SIDED|95.0|8.6|22.3|||2 sided calculated using continuity|2 sided calculated using continuity adjusted Wald Approach||||22.3|8.6|0.0001
72539712|NCT02618772|144609454|SUPERIORITY_OR_OTHER|||||||0.026|||||||t-test, 2 sided|||||||0.026
72539713|NCT02618772|144609455|SUPERIORITY_OR_OTHER|||||||0.036|||||||t-test, 2 sided|||||||0.036
72539714|NCT02618772|144609456|SUPERIORITY_OR_OTHER|||||||0.151||||||This is in reference to the baseline measure.|t-test, 2 sided|||||||0.151
72539715|NCT02618772|144609456|SUPERIORITY_OR_OTHER|||||||0.02||||||This is in reference to the intervention measure.|t-test, 2 sided|||||||0.020
72539716|NCT02618772|144609456|SUPERIORITY_OR_OTHER|||||||0.198||||||This is in reference to the lidocaine measure.|t-test, 2 sided|||||||0.198
72539717|NCT02618772|144609456|SUPERIORITY_OR_OTHER|||||||0.006||||||This is in reference to the difference between the suturing and baseline measures.|t-test, 2 sided|||||||0.006
72539718|NCT02618772|144609457|SUPERIORITY_OR_OTHER|||||||0.185||||||This is in reference to the baseline measure.|t-test, 2 sided|||||||0.185
72539719|NCT02618772|144609457|SUPERIORITY_OR_OTHER|||||||0.011||||||This is in reference to the intervention measure.|t-test, 2 sided|||||||0.011
72539720|NCT02618772|144609457|SUPERIORITY_OR_OTHER|||||||0.191||||||This is in reference to the lidocaine measure.|t-test, 2 sided|||||||0.191
72539721|NCT02618772|144609457|SUPERIORITY_OR_OTHER|||||||0.008||||||This is in reference to the difference between the suturing and baseline measures.|t-test, 2 sided|||||||0.008
72539722|NCT02618772|144609458|SUPERIORITY_OR_OTHER|||||||0.004||||||This p value is a t-test of the Post STAI minus Pre STAI variable.|t-test, 2 sided|||||||0.004
72539723|NCT02618772|144609459|SUPERIORITY_OR_OTHER|||||||0.015||||||This p value is in reference to the t-test performed for STAI Post Minus STAI Pre.|t-test, 2 sided|||||||0.015
72539724|NCT02618772|144609460|SUPERIORITY_OR_OTHER|||||||0.08|||||||t-test, 2 sided|||||||0.080
72539725|NCT02618772|144609461|SUPERIORITY_OR_OTHER|||||||0.086|||||||t-test, 2 sided|||||||0.086
72539726|NCT02618772|144609462|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
72539727|NCT02618772|144609463|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
72539728|NCT01289990|144609471|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.79|STANDARD_ERROR_OF_MEAN|0.08|<|0.0001|TWO_SIDED|95.0|-0.94|-0.64||Model includes baseline HbA1c as a linear covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, and treatment as fixed effects.|ANCOVA|||statistical analysis at week 52||-0.64|-0.94|<0.0001
72539729|NCT01289990|144609471|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.91|STANDARD_ERROR_OF_MEAN|0.08|<|0.0001|TWO_SIDED|95.0|-1.06|-0.76||Model includes baseline HbA1c as a linear covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, and treatment as fixed effects.|ANCOVA|||statistical analysis at week 52||-0.76|-1.06|<0.0001
72539730|NCT01289990|144609471|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.67|STANDARD_ERROR_OF_MEAN|0.08|<|0.0001|TWO_SIDED|95.0|-0.82|-0.52||Model includes baseline HbA1c as a linear covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, and treatment as fixed effects.|ANCOVA|||statistical analysis at week 52||-0.52|-0.82|<0.0001
72539731|NCT01289990|144609471|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.12|STANDARD_ERROR_OF_MEAN|0.08||0.1245|TWO_SIDED|95.0|-0.27|0.03||Model includes baseline HbA1c as a linear covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, and treatment as fixed effects.|ANCOVA|||statistical analysis at week 52||0.03|-0.27|0.1245
72539732|NCT01289990|144609471|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.24|STANDARD_ERROR_OF_MEAN|0.08||0.0022|TWO_SIDED|95.0|-0.39|-0.09||Model includes baseline HbA1c as a linear covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, and treatment as fixed effects.|ANCOVA|||statistical analysis at week 52||-0.09|-0.39|0.0022
72542660|NCT01890785|144615275|SUPERIORITY_OR_OTHER_LEGACY||Ratio of geometric least squares means|0.944|||||TWO_SIDED|90.0|0.912|0.977||||||||0.977|0.912|
72627428|NCT01448616|144783753|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.74||||0.01|TWO_SIDED|95.0|0.59|0.92|||Poisson GLME|||Intent to Treat||0.92|0.59|0.010
72627429|NCT01448616|144783753|SUPERIORITY||Risk Ratio (RR)|1.3||||0.09|TWO_SIDED|95.0|0.9|1.76|||Poisson GLM|||||1.76|0.9|0.09
72627430|NCT01448616|144783753|SUPERIORITY||Risk Ratio (RR)|0.9||||0.47|TWO_SIDED|95.0|0.67|1.22|||Poisson GLM|||Intent to treat analysis||1.22|0.67|0.47
72627431|NCT01991860|144783754|SUPERIORITY|||||||0.033||||||2-sided|Chi-squared, Corrected|Yates's continuity correction||||||0.033
72627432|NCT01991860|144783755|SUPERIORITY|||||||0.16|||||||Chi-squared, Corrected|Yates's continuity correction||||||0.16
72627433|NCT01991860|144783756|SUPERIORITY|||||||0.68|||||||Chi-squared, Corrected|Yates's continuity correction||||||0.68
72627434|NCT01991860|144783757|SUPERIORITY|||||||0.026|||||||Chi-squared, Corrected|Yates's continuity correction||||||0.026
72409704|NCT04116229|144327740|OTHER|"Alternative hypothesis: higher levels of CRP, a pro-inflammatory marker, will relate to higher levels of putative neuroinflammation in white matter tracts as measured by DBSI restricted fraction after controlling for BMI.~Null hypothesis: CRP levels will not be related to DBSI RF in white matter tracts after controlling for BMI."|Slope|0.19||||0.54|TWO_SIDED|||||a priori threshold: p \< 0.05|Regression, Linear|||This is a pilot study with a small sample. Power to detect significant results is therefore low in the current study. Analyses performed across normal-weight and obese groups.||||0.54
72409705|NCT04116229|144327740|OTHER|"Alternative hypothesis: higher levels of CRP, a pro-inflammatory marker, will relate to higher levels of putative neuroinflammation in white matter tracts as measured by DBSI hindered fraction after controlling for BMI.~Null hypothesis: CRP levels will not be related to DBSI HF in white matter tracts after controlling for BMI."|Slope|0.09||||0.77|TWO_SIDED|||||a priori threshold: p \< 0.05|Regression, Linear|||"This is a pilot study with a small sample. Power to detect significant results is therefore low in the current study.~Analyses performed across normal-weight and obese groups."||||0.77
72409706|NCT05209191|144327754|SUPERIORITY||Mean Difference (Net)|7.28|STANDARD_DEVIATION|0.65||0.001|TWO_SIDED||||||t-test, 2 sided|||||||.001
72539733|NCT01289990|144609471|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001|TWO_SIDED|95.0|-0.79|-0.41||Model includes baseline HbA1c as a linear covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, and treatment as fixed effects.|ANCOVA|||||-0.41|-0.79|<0.0001
72539734|NCT01289990|144609471|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.68|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001|TWO_SIDED|95.0|-0.87|-0.49||Model includes baseline HbA1c as a linear covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, and treatment as fixed effects.|ANCOVA|||||-0.49|-0.87|<0.0001
72539735|NCT01289990|144609471|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.62|STANDARD_ERROR_OF_MEAN|0.07|<|0.0001|TWO_SIDED|95.0|-0.75|-0.48||Model includes baseline HbA1c as a linear covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, and treatment as fixed effects.|ANCOVA|||||-0.48|-0.75|<0.0001
72539736|NCT01289990|144609471|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.69|STANDARD_ERROR_OF_MEAN|0.07|<|0.0001|TWO_SIDED|95.0|-0.83|-0.55||Model includes baseline HbA1c as a linear covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, and treatment as fixed effects.|ANCOVA|||||-0.55|-0.83|<0.0001
72539737|NCT01289990|144609471|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.74|STANDARD_ERROR_OF_MEAN|0.08|<|0.0001|TWO_SIDED|95.0|-0.89|-0.59||Model includes baseline HbA1c as a linear covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, and treatment as fixed effects.|ANCOVA|||||-0.59|-0.89|<0.0001
72539738|NCT01289990|144609471|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.7|STANDARD_ERROR_OF_MEAN|0.08|<|0.0001|TWO_SIDED|95.0|-0.85|-0.55||Model includes baseline HbA1c as a linear covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, and treatment as fixed effects.|ANCOVA|||||-0.55|-0.85|<0.0001
72539739|NCT01289990|144609472|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.82|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001|TWO_SIDED|95.0|-1.04|-0.61||Model includes baseline HbA1c as a covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, visit, treatment as fixed effects, and visit by treatment interaction.|Mixed Models Analysis|||||-0.61|-1.04|<0.0001
72539740|NCT01289990|144609472|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.9|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001|TWO_SIDED|95.0|-1.11|-0.69||Model includes baseline HbA1c as a covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, visit, treatment as fixed effects, and visit by treatment interaction.|Mixed Models Analysis|||||-0.69|-1.11|<0.0001
72539741|NCT01289990|144609472|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.21|STANDARD_ERROR_OF_MEAN|0.1||0.0322|TWO_SIDED|95.0|-0.41|-0.02||Model includes baseline HbA1c as a covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, visit, treatment as fixed effects, and visit by treatment interaction.|Mixed Models Analysis|||||-0.02|-0.41|0.0322
72539742|NCT01289990|144609472|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.29|STANDARD_ERROR_OF_MEAN|0.1||0.0038|TWO_SIDED|95.0|-0.48|-0.09||Model includes baseline HbA1c as a covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, visit, treatment as fixed effects, and visit by treatment interaction.|Mixed Models Analysis|||||-0.09|-0.48|0.0038
72539743|NCT01289990|144609472|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.61|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001|TWO_SIDED|95.0|-0.83|-0.4||Model includes baseline HbA1c as a covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, visit, treatment as fixed effects, and visit by treatment interaction.|Mixed Models Analysis|||||-0.40|-0.83|<0.0001
72539744|NCT01289990|144609472|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.62|STANDARD_ERROR_OF_MEAN|0.15|<|0.0001|TWO_SIDED|95.0|-0.9|-0.33||Model includes baseline HbA1c as a covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, visit, treatment as fixed effects, and visit by treatment interaction.|Mixed Models Analysis|||||-0.33|-0.90|<0.0001
72539745|NCT01289990|144609472|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.72|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-1.0|-0.44||Model includes baseline HbA1c as a covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, visit, treatment as fixed effects, and visit by treatment interaction.|Mixed Models Analysis|||||-0.44|-1.00|<0.0001
72539746|NCT01289990|144609472|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.67|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001|TWO_SIDED|95.0|-0.87|-0.47||Model includes baseline HbA1c as a covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, visit, treatment as fixed effects, and visit by treatment interaction.|Mixed Models Analysis|||||-0.47|-0.87|<0.0001
72409707|NCT05209191|144327756|SUPERIORITY||Mean Difference (Net)|0.08||||0.38|TWO_SIDED||||||t-test, 2 sided|||Paired t-test.||||.38
72409708|NCT05209191|144327757|SUPERIORITY||Chi square|52.07||||0.001|TWO_SIDED||||||Chi-squared|||||||.001
72539747|NCT01289990|144609472|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.83|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001|TWO_SIDED|95.0|-1.04|-0.63||Model includes baseline HbA1c as a covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, visit, treatment as fixed effects, and visit by treatment interaction.|Mixed Models Analysis|||||-0.63|-1.04|<0.0001
72542661|NCT01890785|144615276|SUPERIORITY_OR_OTHER_LEGACY||Ratio of geometric least squares means|0.971|||||TWO_SIDED|90.0|0.945|0.998||||||||0.998|0.945|
72542662|NCT01890785|144615276|SUPERIORITY_OR_OTHER_LEGACY||Ratio of geometric least squares means|0.97|||||TWO_SIDED|90.0|0.944|0.997||||||||0.997|0.944|
72539748|NCT01289990|144609472|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.8|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-1.04|-0.57||Model includes baseline HbA1c as a covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, visit, treatment as fixed effects, and visit by treatment interaction.|Mixed Models Analysis|||||-0.57|-1.04|<0.0001
72539749|NCT01289990|144609472|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.8|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-1.04|-0.56||Model includes baseline HbA1c as a covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, visit, treatment as fixed effects, and visit by treatment interaction.|Mixed Models Analysis|||||-0.56|-1.04|<0.0001
72539750|NCT01289990|144609473|SUPERIORITY_OR_OTHER||Adjusted mean difference|-4.6|STANDARD_ERROR_OF_MEAN|1.1|<|0.0001|TWO_SIDED|95.0|-6.8|-2.5||Model includes baseline sys blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-2.5|-6.8|<0.0001
72539751|NCT01289990|144609473|SUPERIORITY_OR_OTHER||Adjusted mean difference|-4.2|STANDARD_ERROR_OF_MEAN|1.1||0.0001|TWO_SIDED|95.0|-6.4|-2.1||Model includes baseline sys blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-2.1|-6.4|0.0001
72575315|NCT01338870|144676546|SUPERIORITY_OR_OTHER||LS mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.07||0.0695|TWO_SIDED|80.0|-0.19|-0.01|||Mixed Models Analysis|||Week 2: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction, baseline-by-treatment interaction, baseline-by-treatment-by-time interaction as the covariates, time was repeated for participant.||-0.01|-0.19|0.0695
72575316|NCT01338870|144676546|SUPERIORITY_OR_OTHER||LS mean difference|-0.11|STANDARD_ERROR_OF_MEAN|0.069||0.0636|TWO_SIDED|80.0|-0.2|-0.02|||Mixed Models Analysis|||Week 2: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction, baseline-by-treatment interaction, baseline-by-treatment-by-time interaction as the covariates, time was repeated for participant.||-0.02|-0.20|0.0636
72575317|NCT01338870|144676546|SUPERIORITY_OR_OTHER||LS mean difference|-0.11|STANDARD_ERROR_OF_MEAN|0.069||0.0512|TWO_SIDED|80.0|-0.2|-0.02|||Mixed Models Analysis|||Week 2: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction, baseline-by-treatment interaction, baseline-by-treatment-by-time interaction as the covariates, time was repeated for participant.||-0.02|-0.20|0.0512
72575318|NCT01338870|144676546|SUPERIORITY_OR_OTHER||LS mean difference|-0.18|STANDARD_ERROR_OF_MEAN|0.068||0.0051|TWO_SIDED|80.0|-0.26|-0.09|||Mixed Models Analysis|||Week 2: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction, baseline-by-treatment interaction, baseline-by-treatment-by-time interaction as the covariates, time was repeated for participant.||-0.09|-0.26|0.0051
72575319|NCT01338870|144676546|SUPERIORITY_OR_OTHER||LS mean difference|-0.22|STANDARD_ERROR_OF_MEAN|0.069||0.0009|TWO_SIDED|80.0|-0.3|-0.13|||Mixed Models Analysis|||Week 2: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction, baseline-by-treatment interaction, baseline-by-treatment-by-time interaction as the covariates, time was repeated for participant.||-0.13|-0.30|0.0009
72575320|NCT01338870|144676546|SUPERIORITY_OR_OTHER||LS mean difference|-0.07|STANDARD_ERROR_OF_MEAN|0.094||0.2392|TWO_SIDED|80.0|-0.19|0.05|||Mixed Models Analysis|||Week 4: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction, baseline-by-treatment interaction, baseline-by-treatment-by-time interaction as the covariates, time was repeated for participant.||0.05|-0.19|0.2392
72575321|NCT01338870|144676546|SUPERIORITY_OR_OTHER||LS mean difference|-0.17|STANDARD_ERROR_OF_MEAN|0.091||0.0308|TWO_SIDED|80.0|-0.29|-0.05|||Mixed Models Analysis|||Week 4: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction, baseline-by-treatment interaction, baseline-by-treatment-by-time interaction as the covariates, time was repeated for participant.||-0.05|-0.29|0.0308
72627435|NCT01991860|144783758|SUPERIORITY|||||||0.086|||||||Chi-squared, Corrected|Yates's continuity correction||||||0.086
72627436|NCT01991860|144783759|SUPERIORITY|||||||0.074|||||||Chi-squared, Corrected|Yates's continuity correction||||||0.074
72627437|NCT01991860|144783760|SUPERIORITY|||||||0.15|||||||Chi-squared, Corrected|Yates's continuity correction||||||0.15
72627438|NCT00485173|144783768|NON_INFERIORITY_OR_EQUIVALENCE|The predefined non-inferiority margin was 0.10.|||||<|0.001||95.0||||P-value was one-sided from random samplings, based on logistic regression model by using propensity score as a covariate.|Regression, Logistic|||||||<0.001
72627439|NCT00485173|144783768|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value was one-sided, obtained from logistic regression model by using propensity score as a covariate.|Regression, Logistic|||Superiority comparison of success rates in two treatment groups was a secondary objective of this trial. Superiority analysis was performed if non-inferiority was demonstrated.||||<0.001
72627440|NCT00485173|144783769|NON_INFERIORITY_OR_EQUIVALENCE|The predefined non-inferiority margin was 0.10.|||||<|0.001||95.0||||P-value was one-sided from random samplings, based on logistic regression model by using propensity score as a covariate.|Regression, Logistic|||||||<0.001
72627441|NCT00485173|144783769|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||P-value was one-sided, obtained from logistic regression model by using propensity score as a covariate.|Regression, Logistic|||Superiority analysis was performed if non-inferiority was demonstrated.||||0.002
72627442|NCT00485173|144783770|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||P-value was one-sided, adjusted from ANCOVA with the propensity score as the covariate.|ANCOVA|||||||0.002
72627443|NCT00485173|144783771|NON_INFERIORITY_OR_EQUIVALENCE|The predefined non-inferiority margin was 0.10.|||||<|0.001||95.0||||P-value was one-sided from random sampling, based on covariance matrix produced by logistic regression using propensity score as a covariate.|Regression, Logistic|||||||<0.001
72539752|NCT01289990|144609473|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.4|STANDARD_ERROR_OF_MEAN|1.1||0.2107|TWO_SIDED|95.0|-3.5|0.8||Model includes baseline sys blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||0.8|-3.5|0.2107
72539753|NCT01289990|144609473|SUPERIORITY_OR_OTHER||Adjusted mean difference|-3.3|STANDARD_ERROR_OF_MEAN|1.1||0.0033|TWO_SIDED|95.0|-5.4|-1.1||Model includes baseline sys blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-1.1|-5.4|0.0033
72539754|NCT01289990|144609473|SUPERIORITY_OR_OTHER||Adjusted mean difference|-2.8|STANDARD_ERROR_OF_MEAN|1.1||0.0105|TWO_SIDED|95.0|-5.0|-0.7||Model includes baseline sys blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-0.7|-5.0|0.0105
72539755|NCT01289990|144609473|SUPERIORITY_OR_OTHER||Adjusted mean difference|-2.4|STANDARD_ERROR_OF_MEAN|1.3||0.0543|TWO_SIDED|95.0|-4.9|0.0||Model includes baseline sys blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||0.0|-4.9|0.0543
72539756|NCT01289990|144609473|SUPERIORITY_OR_OTHER||Adjusted mean difference|-3.9|STANDARD_ERROR_OF_MEAN|1.2||0.0019|TWO_SIDED|95.0|-6.4|-1.5||Model includes baseline sys blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-1.5|-6.4|0.0019
72539757|NCT01289990|144609473|SUPERIORITY_OR_OTHER||Adjusted mean difference|-3.0|STANDARD_ERROR_OF_MEAN|1.0||0.0045|TWO_SIDED|95.0|-5.0|-0.9||Model includes baseline sys blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-0.9|-5.0|0.0045
72539758|NCT01289990|144609473|SUPERIORITY_OR_OTHER||Adjusted mean difference|-4.5|STANDARD_ERROR_OF_MEAN|1.0|<|0.0001|TWO_SIDED|95.0|-6.6|-2.5||Model includes baseline sys blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-2.5|-6.6|<0.0001
72539759|NCT01289990|144609473|SUPERIORITY_OR_OTHER||Adjusted mean difference|-2.9|STANDARD_ERROR_OF_MEAN|1.0||0.0031|TWO_SIDED|95.0|-4.8|-1.0||Model includes baseline sys blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-1.0|-4.8|0.0031
72539760|NCT01289990|144609473|SUPERIORITY_OR_OTHER||Adjusted mean difference|-2.5|STANDARD_ERROR_OF_MEAN|1.0||0.0096|TWO_SIDED|95.0|-4.4|-0.6||Model includes baseline sys blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-0.6|-4.4|0.0096
72539761|NCT01289990|144609474|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.78|STANDARD_ERROR_OF_MEAN|0.08|<|0.0001|TWO_SIDED|95.0|-0.94|-0.63||Model includes baseline HbA1c as a linear covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, and treatment as fixed effects.|ANCOVA|||||-0.63|-0.94|<0.0001
72539762|NCT01289990|144609474|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.89|STANDARD_ERROR_OF_MEAN|0.08|<|0.0001|TWO_SIDED|95.0|-1.04|-0.73||Model includes baseline HbA1c as a linear covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, and treatment as fixed effects.|ANCOVA|||||-0.73|-1.04|<0.0001
72539763|NCT01289990|144609474|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.66|STANDARD_ERROR_OF_MEAN|0.08|<|0.0001|TWO_SIDED|95.0|-0.82|-0.51||Model includes baseline HbA1c as a linear covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, and treatment as fixed effects.|ANCOVA|||||-0.51|-0.82|<0.0001
72539764|NCT01289990|144609474|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.12|STANDARD_ERROR_OF_MEAN|0.08||0.131|TWO_SIDED|95.0|-0.28|0.04||Model includes baseline HbA1c as a linear covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, and treatment as fixed effects.|ANCOVA|||||0.04|-0.28|0.1310
72539765|NCT01289990|144609474|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.22|STANDARD_ERROR_OF_MEAN|0.08||0.005|TWO_SIDED|95.0|-0.38|-0.07||Model includes baseline HbA1c as a linear covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, and treatment as fixed effects.|ANCOVA|||||-0.07|-0.38|0.0050
72539766|NCT01289990|144609474|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.59|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001|TWO_SIDED|95.0|-0.79|-0.4||Model includes baseline HbA1c as a linear covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, and treatment as fixed effects.|ANCOVA|||||-0.40|-0.79|<0.0001
72539767|NCT01289990|144609474|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.69|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001|TWO_SIDED|95.0|-0.88|-0.5||Model includes baseline HbA1c as a linear covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, and treatment as fixed effects.|ANCOVA|||||-0.50|-0.88|<0.0001
72575322|NCT01338870|144676546|SUPERIORITY_OR_OTHER||LS mean difference|-0.27|STANDARD_ERROR_OF_MEAN|0.091||0.0019|TWO_SIDED|80.0|-0.38|-0.15|||Mixed Models Analysis|||Week 4: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction, baseline-by-treatment interaction, baseline-by-treatment-by-time interaction as the covariates, time was repeated for participant.||-0.15|-0.38|0.0019
72575323|NCT01338870|144676546|SUPERIORITY_OR_OTHER||LS mean difference|-0.24|STANDARD_ERROR_OF_MEAN|0.089||0.0034|TWO_SIDED|80.0|-0.36|-0.13|||Mixed Models Analysis|||Week 4: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction, baseline-by-treatment interaction, baseline-by-treatment-by-time interaction as the covariates, time was repeated for participant.||-0.13|-0.36|0.0034
72575324|NCT01338870|144676546|SUPERIORITY_OR_OTHER||LS mean difference|-0.32|STANDARD_ERROR_OF_MEAN|0.09||0.0002|TWO_SIDED|80.0|-0.44|-0.21|||Mixed Models Analysis|||Week 4: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction, baseline-by-treatment interaction, baseline-by-treatment-by-time interaction as the covariates, time was repeated for participant.||-0.21|-0.44|0.0002
72409709|NCT01229228|144327758|SUPERIORITY_OR_OTHER||Mean Difference (Net)|22.417|STANDARD_ERROR_OF_MEAN|2.7891|<|0.001|TWO_SIDED|95.0|16.923|27.91|||ANCOVA|||||27.910|16.923|<0.001
72409710|NCT03759223|144327794|SUPERIORITY|||||||0.04||||||0:24 weeks|Mixed Models Analysis|||||||.04
72409711|NCT03759223|144327794|SUPERIORITY|||||||0.05||||||0:24 weeks|Mixed Models Analysis|||||||.05
72539768|NCT01289990|144609474|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.61|STANDARD_ERROR_OF_MEAN|0.07|<|0.0001|TWO_SIDED|95.0|-0.75|-0.46||Model includes baseline HbA1c as a linear covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, and treatment as fixed effects.|ANCOVA|||||-0.46|-0.75|<0.0001
72539769|NCT01289990|144609474|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.73|STANDARD_ERROR_OF_MEAN|0.07|<|0.0001|TWO_SIDED|95.0|-0.88|-0.58||Model includes baseline HbA1c as a linear covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, and treatment as fixed effects.|ANCOVA|||||-0.58|-0.88|<0.0001
72539770|NCT01289990|144609474|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.72|STANDARD_ERROR_OF_MEAN|0.08|<|0.0001|TWO_SIDED|95.0|-0.87|-0.56|||ANCOVA|||||-0.56|-0.87|<0.0001
72539771|NCT01289990|144609474|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.69|STANDARD_ERROR_OF_MEAN|0.08|<|0.0001|TWO_SIDED|95.0|-0.85|-0.53||Model includes baseline HbA1c as a linear covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, and treatment as fixed effects.|ANCOVA|||||-0.53|-0.85|<0.0001
72539772|NCT01289990|144609475|SUPERIORITY_OR_OTHER||Adjusted mean difference|-3.4|STANDARD_ERROR_OF_MEAN|1.1||0.0025|TWO_SIDED|95.0|-5.5|-1.2||Model includes baseline sys blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-1.2|-5.5|0.0025
72539773|NCT01289990|144609475|SUPERIORITY_OR_OTHER||Adjusted mean difference|-3.4|STANDARD_ERROR_OF_MEAN|1.1||0.0021|TWO_SIDED|95.0|-5.6|-1.2||Model includes baseline sys blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-1.2|-5.6|0.0021
72539774|NCT01289990|144609475|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.4|STANDARD_ERROR_OF_MEAN|1.1||0.7241|TWO_SIDED|95.0|-1.8|2.6||Model includes baseline sys blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||2.6|-1.8|0.7241
72539775|NCT01289990|144609475|SUPERIORITY_OR_OTHER||Adjusted mean difference|-3.7|STANDARD_ERROR_OF_MEAN|1.1||0.0008|TWO_SIDED|95.0|-5.9|-1.6||Model includes baseline sys blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-1.6|-5.9|0.0008
72539776|NCT01289990|144609475|SUPERIORITY_OR_OTHER||Adjusted mean difference|-3.8|STANDARD_ERROR_OF_MEAN|1.1||0.0007|TWO_SIDED|95.0|-6.0|-1.6||Model includes baseline sys blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-1.6|-6.0|0.0007
72539777|NCT01289990|144609475|SUPERIORITY_OR_OTHER||Adjusted mean difference|-2.0|STANDARD_ERROR_OF_MEAN|1.2||0.0987|TWO_SIDED|95.0|-4.5|0.4||Model includes baseline sys blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||0.4|-4.5|0.0987
72409712|NCT03759223|144327794|SUPERIORITY|||||||0.58||||||12:12 weeks|Mixed Models Analysis|||||||.58
72409713|NCT01599650|144327807|SUPERIORITY_OR_OTHER||difference in LS mean|10.0|STANDARD_ERROR_OF_MEAN|1.41|<|0.0001|TWO_SIDED|95.0|7.3|12.8|||ANOVA|||||12.8|7.3|<0.0001
72409714|NCT01599650|144327807|SUPERIORITY_OR_OTHER||difference in LS Means|8.7|STANDARD_ERROR_OF_MEAN|1.46|<|0.0001|TWO_SIDED|95.0|5.8|11.6|||ANOVA|||||11.6|5.8|<0.0001
72409715|NCT02802345|144327818|SUPERIORITY||Adjusted mean difference|-0.52|STANDARD_ERROR_OF_MEAN|1.431||0.7191|TWO_SIDED|95.0|-3.33|2.3|||Mixed Model for Repeated Measures (MMRM)|The Roger- Kenward approximation was used to estimate denominator degrees of freedom.|Adjusted mean difference (Nintedanib +placebo vs Nintedanib+sildenafil) is based on all analyzed patients in the model (not only patients with a measurement at baseline and at 12 weeks).|Mixed Model for Repeated Measures (MMRM) included fixed effects for treatment, visit, presence of any echocardiographic signs, baseline SGRQ total score as covariate, treatment-by-visit and baseline SGRQ total score-by-visit interaction terms using an unstructured covariance matrix. No imputation was planned. Data collected after Visit 5 (planned 12 weeks after start of study treatment) were not used for this analysis.|"H0: There is no difference in the mean change from baseline in SGRQ total score at Week 12 between treatment with nintedanib co-administered with sildenafil and treatment with nintedanib alone.~Ha: There is a difference in the mean change from baseline in SGRQ total score at Week 12 between treatment with nintedanib co-administered with sildenafil and treatment with nintedanib alone."|2.30|-3.33|0.7191
72539778|NCT01289990|144609475|SUPERIORITY_OR_OTHER||Adjusted mean difference|-3.7|STANDARD_ERROR_OF_MEAN|1.2||0.0028|TWO_SIDED|95.0|-6.1|-1.3||Model includes baseline sys blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-1.3|-6.1|0.0028
72539779|NCT01289990|144609475|SUPERIORITY_OR_OTHER||Adjusted mean difference|-4.4|STANDARD_ERROR_OF_MEAN|1.1|<|0.0001|TWO_SIDED|95.0|-6.6|-2.3||Model includes baseline sys blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-2.3|-6.6|<0.0001
72539780|NCT01289990|144609475|SUPERIORITY_OR_OTHER||Adjusted mean difference|-3.7|STANDARD_ERROR_OF_MEAN|1.1||0.0008|TWO_SIDED|95.0|-5.9|-1.5||Model includes baseline sys blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-1.5|-5.9|0.0008
72539781|NCT01289990|144609475|SUPERIORITY_OR_OTHER||Adjusted mean difference|-2.2|STANDARD_ERROR_OF_MEAN|1.0||0.0213|TWO_SIDED|95.0|-4.1|-0.3||Model includes baseline sys blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-0.3|-4.1|0.0213
72539782|NCT01289990|144609475|SUPERIORITY_OR_OTHER||Adjusted mean difference|-2.1|STANDARD_ERROR_OF_MEAN|1.0||0.0288|TWO_SIDED|95.0|-4.1|-0.2||Model includes baseline sys blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-0.2|-4.1|0.0288
72539783|NCT01289990|144609476|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.1|STANDARD_ERROR_OF_MEAN|0.7||0.1058|TWO_SIDED|95.0|-2.4|0.2||Model includes baseline diastolic blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||0.2|-2.4|0.1058
72539784|NCT01289990|144609476|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.7|STANDARD_ERROR_OF_MEAN|0.7||0.0109|TWO_SIDED|95.0|-3.1|-0.4||Model includes baseline diastolic blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-0.4|-3.1|0.0109
72627444|NCT00485173|144783771|SUPERIORITY_OR_OTHER|||||||0.011||95.0||||P-value was one-sided, obtained from logistic regression model by using propensity score as a covariate.|Regression, Logistic|||Superiority analysis was performed if non-inferiority was demonstrated.||||0.011
72409716|NCT02802345|144327819|SUPERIORITY||Adjusted mean difference|-2.94|STANDARD_ERROR_OF_MEAN|2.198||0.1823|TWO_SIDED|95.0|-7.27|1.39|||Mixed Model for Repeated Measures (MMRM)|The Roger- Kenward approximation was used to estimate denominator degrees of freedom.|Adjusted mean difference (Nintedanib +placebo vs Nintedanib+sildenafil) is based on all analyzed patients in the model (not only patients with a measurement at baseline and at 12 weeks)|Mixed Model for Repeated Measures (MMRM) included fixed effects for treatment, visit, presence of any echocardiographic signs, baseline UCSD SOBQ total score as covariate, treatment-by-visit and baseline UCSD SOBQ total score-by-visit interaction terms using an unstructured covariance matrix. No imputation was planned. Data collected after Visit 5 (planned 12 weeks after start of study treatment) were not used for this analysis.||1.39|-7.27|0.1823
72409717|NCT02802345|144327820|SUPERIORITY||Adjusted mean difference|-2.19|STANDARD_ERROR_OF_MEAN|1.631||0.1809|TWO_SIDED|95.0|-5.4|1.02|||Mixed Model for Repeated Measures (MMRM)|The Roger- Kenward approximation was used to estimate denominator degrees of freedom.|Adjusted mean difference (Nintedanib +placebo vs Nintedanib+sildenafil) is based on all analyzed patients in the model (not only patients with a measurement at baseline and at 24 weeks)|Mixed Model for Repeated Measures (MMRM) included fixed effects for treatment, visit, presence of any echocardiographic signs, baseline SGRQ total score as covariate, treatment-by-visit and baseline SGRQ total score-by-visit interaction terms using an unstructured covariance matrix. No imputation was planned.||1.02|-5.40|0.1809
72409718|NCT02802345|144327821|SUPERIORITY||Adjusted mean difference|-2.41|STANDARD_ERROR_OF_MEAN|2.529||0.3421|TWO_SIDED|95.0|-7.39|2.58|||Mixed Model for Repeated Measures (MMRM)|The Roger- Kenward approximation was used to estimate denominator degrees of freedom.|Adjusted mean difference (Nintedanib +placebo vs Nintedanib+sildenafil) is based on all analyzed patients in the model (not only patients with a measurement at baseline and at 24 weeks)|Mixed Model for Repeated Measures (MMRM) included fixed effects for treatment, visit, presence of any echocardiographic signs, baseline UCSD SOBQ total score as covariate, treatment-by-visit and baseline UCSD SOBQ total score-by-visit interaction terms using an unstructured covariance matrix. No imputation was planned.||2.58|-7.39|0.3421
72409719|NCT02802345|144327822|SUPERIORITY||Percentage ratio (%)|0.83|||||TWO_SIDED|95.0|0.58|1.2|||||Within strata confidence limits are calculated according to Wald. Percentage ratio = (% of Nintedanib+sildenafil) / (% of Nintedanib+placebo).|Relative risk, Comparison of treatment groups is calculated by Cochran-Mantel-Haenszel test adjusting for the categorical covariate presence of any echocardiographic signs indicative of right heart dysfunction (yes/no), adjusted Mantel-Haenszel type risk ratios and risk differences with 95% confidence are presented.||1.20|0.58|
72539785|NCT01289990|144609476|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.7||0.8259|TWO_SIDED|95.0|-1.5|1.2||Model includes baseline diastolic blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||1.2|-1.5|0.8259
72539786|NCT01289990|144609476|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.9|STANDARD_ERROR_OF_MEAN|0.7||0.166|TWO_SIDED|95.0|-2.3|0.4||Model includes baseline diastolic blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||0.4|-2.3|0.1660
72539787|NCT01289990|144609476|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.6|STANDARD_ERROR_OF_MEAN|0.7||0.0212|TWO_SIDED|95.0|-2.9|-0.2||Model includes baseline diastolic blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-0.2|-2.9|0.0212
72539788|NCT01289990|144609476|SUPERIORITY_OR_OTHER||Adjusted mean difference|-2.0|STANDARD_ERROR_OF_MEAN|0.7||0.0076|TWO_SIDED|95.0|-3.4|-0.5||Model includes baseline diastolic blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-0.5|-3.4|0.0076
72539789|NCT01289990|144609476|SUPERIORITY_OR_OTHER||Adjusted mean difference|-2.6|STANDARD_ERROR_OF_MEAN|0.7||0.0003|TWO_SIDED|95.0|-4.1|-1.2||Model includes baseline diastolic blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-1.2|-4.1|0.0003
72539790|NCT01289990|144609476|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.8|STANDARD_ERROR_OF_MEAN|0.7||0.017|TWO_SIDED|95.0|-3.2|-0.3||Model includes baseline diastolic blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-0.3|-3.2|0.0170
72539791|NCT01289990|144609476|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.7|STANDARD_ERROR_OF_MEAN|0.7||0.0236|TWO_SIDED|95.0|-3.1|-0.2||Model includes baseline diastolic blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-0.2|-3.1|0.0236
72539792|NCT01289990|144609476|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.7|STANDARD_ERROR_OF_MEAN|0.6||0.2523|TWO_SIDED|95.0|-2.0|0.5||Model includes baseline diastolic blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||0.5|-2.0|0.2523
72539793|NCT01289990|144609476|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.6||0.3494|TWO_SIDED|95.0|-1.9|0.7||Model includes baseline diastolic blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||0.7|-1.9|0.3494
72539794|NCT01289990|144609477|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.0|STANDARD_ERROR_OF_MEAN|0.7||0.1568|TWO_SIDED|95.0|-2.3|0.4||Model includes baseline diastolic blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||0.4|-2.3|0.1568
72539795|NCT01289990|144609477|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.0|STANDARD_ERROR_OF_MEAN|0.7||0.1323|TWO_SIDED|95.0|-2.4|0.3||Model includes baseline diastolic blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||0.3|-2.4|0.1323
72627445|NCT00485173|144783772|SUPERIORITY_OR_OTHER|||||||0.063||95.0||||P-value was one-sided, adjusted from ANCOVA with the propensity score as the covariate.|ANCOVA|||||||0.063
72627446|NCT00485173|144783773|NON_INFERIORITY_OR_EQUIVALENCE|The predefined non-inferiority margin was 0.10.|||||<|0.001||95.0||||P-value was one-sided from random samplings, based on logistic regression model by using propensity score as a covariate.|Regression, Logistic|||||||<0.001
72539796|NCT01289990|144609477|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.5|STANDARD_ERROR_OF_MEAN|0.7||0.4327|TWO_SIDED|95.0|-0.8|1.9||Model includes baseline diastolic blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||1.9|-0.8|0.4327
72539797|NCT01289990|144609477|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.5|STANDARD_ERROR_OF_MEAN|0.7||0.0289|TWO_SIDED|95.0|-2.8|-0.2||Model includes baseline diastolic blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-0.2|-2.8|0.0289
72539798|NCT01289990|144609477|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.6|STANDARD_ERROR_OF_MEAN|0.7||0.0231|TWO_SIDED|95.0|-2.9|-0.2||Model includes baseline diastolic blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-0.2|-2.9|0.0231
72539799|NCT01289990|144609477|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.5|STANDARD_ERROR_OF_MEAN|0.8||0.0513|TWO_SIDED|95.0|-3.0|0.0||Model includes baseline diastolic blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||0.0|-3.0|0.0513
72539800|NCT01289990|144609477|SUPERIORITY_OR_OTHER||Adjusted mean difference|-2.2|STANDARD_ERROR_OF_MEAN|0.8||0.0038|TWO_SIDED|95.0|-3.7|-0.7||Model includes baseline diastolic blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-0.7|-3.7|0.0038
72539801|NCT01289990|144609477|SUPERIORITY_OR_OTHER||Adjusted mean difference|-2.0|STANDARD_ERROR_OF_MEAN|0.7||0.0084|TWO_SIDED|95.0|-3.4|-0.5||Model includes baseline diastolic blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-0.5|-3.4|0.0084
72539802|NCT01289990|144609477|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.4|STANDARD_ERROR_OF_MEAN|0.7||0.0677|TWO_SIDED|95.0|-2.8|0.1||Model includes baseline diastolic blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||0.1|-2.8|0.0677
72539803|NCT01289990|144609477|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.1|STANDARD_ERROR_OF_MEAN|0.7||0.0814|TWO_SIDED|95.0|-2.4|0.1||Model includes baseline diastolic blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||0.1|-2.4|0.0814
72539804|NCT01289990|144609477|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.9|STANDARD_ERROR_OF_MEAN|0.7||0.1785|TWO_SIDED|95.0|-2.2|0.4||Model includes baseline diastolic blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||0.4|-2.2|0.1785
72539805|NCT01289990|144609478|SUPERIORITY_OR_OTHER||Adjusted mean difference|-2.22|STANDARD_ERROR_OF_MEAN|0.27|<|0.0001|TWO_SIDED|95.0|-2.75|-1.69||Model includes baseline weight, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-1.69|-2.75|<0.0001
72539806|NCT01289990|144609478|SUPERIORITY_OR_OTHER||Adjusted mean difference|-2.14|STANDARD_ERROR_OF_MEAN|0.27|<|0.0001|TWO_SIDED|95.0|-2.66|-1.61||Model includes baseline weight, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-1.61|-2.66|<0.0001
72539807|NCT01289990|144609478|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.62|STANDARD_ERROR_OF_MEAN|0.27||0.0223|TWO_SIDED|95.0|0.09|1.14||Model includes baseline weight, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||1.14|0.09|0.0223
72539808|NCT01289990|144609478|SUPERIORITY_OR_OTHER||Adjusted mean difference|-2.84|STANDARD_ERROR_OF_MEAN|0.27|<|0.0001|TWO_SIDED|95.0|-3.37|-2.31||Model includes baseline weight, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-2.31|-3.37|<0.0001
72539809|NCT01289990|144609478|SUPERIORITY_OR_OTHER||Adjusted mean difference|-2.75|STANDARD_ERROR_OF_MEAN|0.27|<|0.0001|TWO_SIDED|95.0|-3.28|-2.22|||ANCOVA|||||-2.22|-3.28|<0.0001
72539810|NCT01289990|144609478|SUPERIORITY_OR_OTHER||Adjusted mean difference|-2.09|STANDARD_ERROR_OF_MEAN|0.34|<|0.0001|TWO_SIDED|95.0|-2.76|-1.41||Model includes baseline weight, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-1.41|-2.76|<0.0001
72539811|NCT01289990|144609478|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.99|STANDARD_ERROR_OF_MEAN|0.34|<|0.0001|TWO_SIDED|95.0|-2.66|-1.32||Model includes baseline weight, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-1.32|-2.66|<0.0001
72539812|NCT01289990|144609478|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.73|STANDARD_ERROR_OF_MEAN|0.28|<|0.0001|TWO_SIDED|95.0|-2.27|-1.19||Model includes baseline weight, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-1.19|-2.27|<0.0001
72539813|NCT01289990|144609478|SUPERIORITY_OR_OTHER||Adjusted mean difference|-2.3|STANDARD_ERROR_OF_MEAN|0.28|<|0.0001|TWO_SIDED|95.0|-2.85|-1.76||Model includes baseline weight, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-1.76|-2.85|<0.0001
72539814|NCT01289990|144609478|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.97|STANDARD_ERROR_OF_MEAN|0.26|<|0.0001|TWO_SIDED|95.0|-2.48|-1.47||Model includes baseline weight, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-1.47|-2.48|<0.0001
72539815|NCT01289990|144609478|SUPERIORITY_OR_OTHER||Adjusted mean difference|-2.01|STANDARD_ERROR_OF_MEAN|0.26|<|0.0001|TWO_SIDED|95.0|-2.52|-1.5||Model includes baseline weight, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-1.50|-2.52|<0.0001
72539816|NCT01289990|144609479|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.81|STANDARD_ERROR_OF_MEAN|0.28|<|0.0001|TWO_SIDED|95.0|-2.35|-1.26||Model includes baseline weight, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-1.26|-2.35|<0.0001
72539817|NCT01289990|144609479|SUPERIORITY_OR_OTHER||Adjusted mean difference|-2.02|STANDARD_ERROR_OF_MEAN|0.28|<|0.0001|TWO_SIDED|95.0|-2.56|-1.48||Model includes baseline weight, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-1.48|-2.56|<0.0001
72539818|NCT01289990|144609479|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.54|STANDARD_ERROR_OF_MEAN|0.28||0.0546|TWO_SIDED|95.0|-0.01|1.08||Model includes baseline weight, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||1.08|-0.01|0.0546
72539819|NCT01289990|144609479|SUPERIORITY_OR_OTHER||Adjusted mean difference|-2.34|STANDARD_ERROR_OF_MEAN|0.28|<|0.0001|TWO_SIDED|95.0|-2.89|-1.8||Model includes baseline weight, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-1.80|-2.89|<0.0001
72627447|NCT00485173|144783773|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value was one-sided, obtained from logistic regression model by using propensity score as a covariate.|Regression, Logistic|||Superiority analysis was performed if non-inferiority was demonstrated.||||<0.001
72409720|NCT02802345|144327822|SUPERIORITY||Percentage difference (%)|-5.37||||0.334|TWO_SIDED|95.0|-16.25|5.52|||Cochran-Mantel-Haenszel||Within strata confidence limits are calculated according to Wald. Percentage difference = (% of Nintedanib+sildenafil) - (% of Nintedanib+placebo).|Risk difference, Comparison of treatment groups is calculated by Cochran-Mantel-Haenszel test adjusting for the categorical covariate presence of any echocardiographic signs indicative of right heart dysfunction (yes/no), adjusted Mantel-Haenszel type risk ratios and risk differences with 95% confidence are presented.||5.52|-16.25|0.334
72409721|NCT02617589|144327878|SUPERIORITY|Hazard Ratio is Nivolumab over Temozolomide|Stratified Cox proportional hazard model|1.31||||0.0037|TWO_SIDED|95.0|1.09|1.58|||Log-rank test stratified|Log-rank test stratified by complete or partial resection at baseline as entered into the IVRS.||||1.58|1.09|0.0037
72409722|NCT02617589|144327879|SUPERIORITY|Hazard Ratio is Nivolumab over Temozolomide|Stratified Cox proportional hazard model|1.43|||||TWO_SIDED|95.0|1.19|1.71|||Log-rank test stratified|Log-rank test stratified by complete or partial resection at baseline as entered into the IVRS.||||1.71|1.19|
72409723|NCT02617589|144327883|SUPERIORITY|Hazard Ratio is Nivolumab over Temozolomide|Stratified Cox proportional hazard model|1.31||||0.0024|TWO_SIDED|95.0|1.1|1.55|||Log-rank test stratified|Log-rank test stratified by complete or partial resection at baseline as entered into the IVRS.||||1.55|1.10|0.0024
72409724|NCT02138214|144327928|OTHER|||||||0.567||||||p-value threshold for statistical significance is 0.05|Fisher Exact|||||||0.567
72409725|NCT02138214|144327929|OTHER|||||||0.11|||||||t-test, 2 sided|||||||0.110
72409726|NCT02138214|144327931|OTHER|||||||0.758|||||||Fisher Exact|||||||0.758
72409727|NCT02138214|144327933|OTHER|||||||0.236|||||||Fisher Exact|||||||0.236
72539820|NCT01289990|144609479|SUPERIORITY_OR_OTHER||Adjusted mean difference|-2.56|STANDARD_ERROR_OF_MEAN|0.28|<|0.0001|TWO_SIDED|95.0|-3.1|-2.01||Model includes baseline weight, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-2.01|-3.10|<0.0001
72409728|NCT02138214|144327934|OTHER|||||||0.759|||||||t-test, 2 sided|||||||0.759
72409729|NCT02138214|144327935|OTHER|||||||0.4|||||||t-test, 2 sided|||||||0.400
72539821|NCT01289990|144609479|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.97|STANDARD_ERROR_OF_MEAN|0.37|<|0.0001|TWO_SIDED|95.0|-2.69|-1.24||Model includes baseline weight, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-1.24|-2.69|<0.0001
72539822|NCT01289990|144609479|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.71|STANDARD_ERROR_OF_MEAN|0.37|<|0.0001|TWO_SIDED|95.0|-2.43|-0.99||Model includes baseline weight, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-0.99|-2.43|<0.0001
72539823|NCT01289990|144609479|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.93|STANDARD_ERROR_OF_MEAN|0.3|<|0.0001|TWO_SIDED|95.0|-2.52|-1.34||Model includes baseline weight, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-1.34|-2.52|<0.0001
72539824|NCT01289990|144609479|SUPERIORITY_OR_OTHER||Adjusted mean difference|-2.19|STANDARD_ERROR_OF_MEAN|0.3|<|0.0001|TWO_SIDED|95.0|-2.79|-1.6||Model includes baseline weight, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-1.60|-2.79|<0.0001
72539825|NCT01289990|144609479|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.81|STANDARD_ERROR_OF_MEAN|0.27|<|0.0001|TWO_SIDED|95.0|-2.34|-1.27||Model includes baseline weight, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-1.27|-2.34|<0.0001
72539826|NCT01289990|144609479|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.64|STANDARD_ERROR_OF_MEAN|0.27|<|0.0001|TWO_SIDED|95.0|-2.18|-1.11||Model includes baseline weight, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-1.11|-2.18|<0.0001
72539827|NCT01289990|144609480|SUPERIORITY_OR_OTHER||Adjusted mean difference|-2.1|STANDARD_ERROR_OF_MEAN|0.5||0.0001|TWO_SIDED|95.0|-3.1|-1.0||Model includes baseline waist circumference, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-1.0|-3.1|0.0001
72539828|NCT01289990|144609480|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.7|STANDARD_ERROR_OF_MEAN|0.5||0.0015|TWO_SIDED|95.0|-2.8|-0.7||Model includes baseline waist circumference, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-0.7|-2.8|0.0015
72539829|NCT01289990|144609480|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.4|STANDARD_ERROR_OF_MEAN|0.5||0.5052|TWO_SIDED|95.0|-0.7|1.4||Model includes baseline waist circumference, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||1.4|-0.7|0.5052
72539830|NCT01289990|144609480|SUPERIORITY_OR_OTHER||Adjusted mean difference|-2.4|STANDARD_ERROR_OF_MEAN|0.5|<|0.0001|TWO_SIDED|95.0|-3.5|-1.4||Model includes baseline waist circumference, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-1.4|-3.5|<0.0001
72539831|NCT01289990|144609480|SUPERIORITY_OR_OTHER||Adjusted mean difference|-2.1|STANDARD_ERROR_OF_MEAN|0.5||0.0001|TWO_SIDED|95.0|-3.1|-1.0||Model includes baseline waist circumference, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-1.0|-3.1|0.0001
72539832|NCT01289990|144609480|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.5|STANDARD_ERROR_OF_MEAN|0.5||0.0064|TWO_SIDED|95.0|-2.6|-0.4||Model includes baseline waist circumference, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-0.4|-2.6|0.0064
72539833|NCT01289990|144609480|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.0|STANDARD_ERROR_OF_MEAN|0.5||0.0642|TWO_SIDED|95.0|-2.1|0.1||Model includes baseline waist circumference, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||0.1|-2.1|0.0642
72539834|NCT01289990|144609480|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.0|STANDARD_ERROR_OF_MEAN|0.4||0.0053|TWO_SIDED|95.0|-1.8|-0.3||Model includes baseline waist circumference, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-0.3|-1.8|0.0053
72539835|NCT01289990|144609480|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.6|STANDARD_ERROR_OF_MEAN|0.4|<|0.0001|TWO_SIDED|95.0|-2.3|-0.9|||ANCOVA|||||-0.9|-2.3|<0.0001
72409730|NCT01196871|144327953|OTHER|Geometric means for each treatment combination is obtained from the linear mixed effects model Log (parameter) = Intercept + ß\*Treatment + Error.|AUC0-t Ratio|2.942|||||TWO_SIDED|90.0|2.439|3.548|||||The ratios of the geometric means (combination/alone) and its 90% CI are obtained by exponentiating the least squares mean difference and its 90% CI of the natural log-transformed data.|Statistical Analysis of Stage 1 AUC0-t Data: Point estimates for the geometric means and their 90% confidence interval (CI) are obtained by exponentiating the least squares mean and the lower and upper bounds of the 90% CI of the natural log-transformed data.||3.548|2.439|
72409731|NCT01196871|144327953|OTHER|Geometric means for each treatment combination is obtained from the linear mixed effects model Log (parameter) = Intercept + ß\*Treatment + Error.|AUCinfinity Ratio|2.942|||||TWO_SIDED|90.0|2.431|3.56|||||The ratios of the geometric means (combination/alone) and its 90% CI are obtained by exponentiating the least squares mean difference and its 90% CI of the natural log-transformed data.|Statistical Analysis of Stage 1 AUCinfinity Data: Point estimates for the geometric means and their 90% CI are obtained by exponentiating the least squares mean and the lower and upper bounds of the 90% CI of the natural log-transformed data.||3.560|2.431|
72409732|NCT01196871|144327953|OTHER|Geometric means for each treatment combination is obtained from the linear mixed effects model Log (parameter) = Intercept + ß\*Treatment + Error.|AUC0-t Ratio|2.354|||||TWO_SIDED|90.0|1.826|3.035|||||The ratios of the geometric means (combination/alone) and its 90% CI are obtained by exponentiating the least squares mean difference and its 90% CI of the natural log-transformed data.|Statistical Analysis of Stage 2 AUC0-t Data: Point estimates for the geometric means and their 90% CI are obtained by exponentiating the least squares mean and the lower and upper bounds of the 90% CI of the natural log-transformed data.||3.035|1.826|
72409733|NCT01196871|144327953|OTHER|Geometric means for each treatment combination is obtained from the linear mixed effects model Log (parameter) = Intercept + ß\*Treatment + Error.|AUCinfinity Ratio|2.375|||||TWO_SIDED|90.0|1.839|3.068|||||The ratios of the geometric means (combination/alone) and its 90% CI are obtained by exponentiating the least squares mean difference and its 90% CI of the natural log-transformed data.|Statistical Analysis of Stage 2 AUCinfinity Data: Point estimates for the geometric means and their 90% CI are obtained by exponentiating the least squares mean and the lower and upper bounds of the 90% CI of the natural log-transformed data.||3.068|1.839|
72409734|NCT01196871|144327954|OTHER|Geometric means for each treatment combination is obtained from the linear mixed effects model Log (parameter) = Intercept + ß\*Treatment + Error.|Cmax Ratio|1.629|||||TWO_SIDED|90.0|1.44|1.843|||||The ratios of the geometric means (combination/alone) and its 90% CI are obtained by exponentiating the least squares mean difference and its 90% CI of the natural log-transformed data.|Statistical Analysis of Stage 1 Cmax Data: Point estimates for the geometric means and their 90% CI are obtained by exponentiating the least squares mean and the lower and upper bounds of the 90% CI of the natural log-transformed data.||1.843|1.440|
72409735|NCT01196871|144327954|OTHER|Geometric means for each treatment combination is obtained from the linear mixed effects model Log (parameter) = Intercept + ß\*Treatment + Error.|Cmax Ratio|1.546|||||TWO_SIDED|90.0|1.3|1.838|||||The ratios of the geometric means (combination/alone) and its 90% CI are obtained by exponentiating the least squares mean difference and its 90% CI of the natural log-transformed data.|Statistical Analysis of Stage 2 Cmax Data: Point estimates for the geometric means and their 90% CI are obtained by exponentiating the least squares mean and the lower and upper bounds of the 90% CI of the natural log-transformed data.||1.838|1.300|
72539836|NCT01289990|144609480|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.3|STANDARD_ERROR_OF_MEAN|0.4||0.001|TWO_SIDED|95.0|-2.1|-0.6||Model includes baseline waist circumference, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-0.6|-2.1|0.0010
72539837|NCT01289990|144609480|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.3|STANDARD_ERROR_OF_MEAN|0.4||0.0015|TWO_SIDED|95.0|-2.1|-0.5||Model includes baseline waist circumference, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-0.5|-2.1|0.0015
72539838|NCT01289990|144609481|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.6|STANDARD_ERROR_OF_MEAN|0.5||0.0028|TWO_SIDED|95.0|-2.7|-0.6||Model includes baseline waist circumference, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-0.6|-2.7|0.0028
72539839|NCT01289990|144609481|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.7|STANDARD_ERROR_OF_MEAN|0.5||0.0019|TWO_SIDED|95.0|-2.8|-0.6||Model includes baseline waist circumference, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-0.6|-2.8|0.0019
72539840|NCT01289990|144609481|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.4|STANDARD_ERROR_OF_MEAN|0.6||0.5044|TWO_SIDED|95.0|-0.7|1.5||Model includes baseline waist circumference, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||1.5|-0.7|0.5044
72539841|NCT01289990|144609481|SUPERIORITY_OR_OTHER||Adjusted mean difference|-2.0|STANDARD_ERROR_OF_MEAN|0.6||0.0003|TWO_SIDED|95.0|-3.1|-0.9||Model includes baseline waist circumference, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-0.9|-3.1|0.0003
72539842|NCT01289990|144609481|SUPERIORITY_OR_OTHER||Adjusted mean difference|-2.1|STANDARD_ERROR_OF_MEAN|0.6||0.0002|TWO_SIDED|95.0|-3.2|-1.0||Model includes baseline waist circumference, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-1.0|-3.2|0.0002
72539843|NCT01289990|144609481|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.4|STANDARD_ERROR_OF_MEAN|0.6||0.0109|TWO_SIDED|95.0|-2.5|-0.3||Model includes baseline waist circumference, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-0.3|-2.5|0.0109
72539844|NCT01289990|144609481|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.9|STANDARD_ERROR_OF_MEAN|0.6||0.1238|TWO_SIDED|95.0|-1.9|0.2||Model includes baseline waist circumference, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||0.2|-1.9|0.1238
72539845|NCT01289990|144609481|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.6|STANDARD_ERROR_OF_MEAN|0.4|<|0.0001|TWO_SIDED|95.0|-2.4|-0.8||Model includes baseline waist circumference, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-0.8|-2.4|<0.0001
72539846|NCT01289990|144609481|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.1|STANDARD_ERROR_OF_MEAN|0.4||0.0076|TWO_SIDED|95.0|-1.9|-0.3||Model includes baseline waist circumference, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-0.3|-1.9|0.0076
72539847|NCT01289990|144609481|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.2|STANDARD_ERROR_OF_MEAN|0.4||0.0049|TWO_SIDED|95.0|-2.1|-0.4||Model includes baseline waist circumference, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-0.4|-2.1|0.0049
72539848|NCT01289990|144609481|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.0|STANDARD_ERROR_OF_MEAN|0.4||0.0178|TWO_SIDED|95.0|-1.9|-0.2||Model includes baseline waist circumference, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-0.2|-1.9|0.0178
72539849|NCT01289990|144609482|SUPERIORITY_OR_OTHER||Adjusted mean difference|-32.3|STANDARD_ERROR_OF_MEAN|2.8|<|0.0001|TWO_SIDED|95.0|-37.8|-26.7||Model includes baseline fasting plasma glucose, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-26.7|-37.8|<0.0001
72539850|NCT01289990|144609482|SUPERIORITY_OR_OTHER||Adjusted mean difference|-37.2|STANDARD_ERROR_OF_MEAN|2.8|<|0.0001|TWO_SIDED|95.0|-42.8|-31.7||Model includes baseline fasting plasma glucose, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-31.7|-42.8|<0.0001
72539851|NCT01289990|144609482|SUPERIORITY_OR_OTHER||Adjusted mean difference|-17.3|STANDARD_ERROR_OF_MEAN|2.8|<|0.0001|TWO_SIDED|95.0|-22.9|-11.7||Model includes baseline fasting plasma glucose, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-11.7|-22.9|<0.0001
72539852|NCT01289990|144609482|SUPERIORITY_OR_OTHER||Adjusted mean difference|-15.0|STANDARD_ERROR_OF_MEAN|2.9|<|0.0001|TWO_SIDED|95.0|-20.6|-9.4||Model includes baseline fasting plasma glucose, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-9.4|-20.6|<0.0001
72539853|NCT01289990|144609482|SUPERIORITY_OR_OTHER||Adjusted mean difference|-19.9|STANDARD_ERROR_OF_MEAN|2.8|<|0.0001|TWO_SIDED|95.0|-25.5|-14.4||Model includes baseline fasting plasma glucose, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-14.4|-25.5|<0.0001
72539854|NCT01289990|144609482|SUPERIORITY_OR_OTHER||Adjusted mean difference|-27.1|STANDARD_ERROR_OF_MEAN|4.0|<|0.0001|TWO_SIDED|95.0|-35.0|-19.2||Model includes baseline fasting plasma glucose, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-19.2|-35.0|<0.0001
72539855|NCT01289990|144609482|SUPERIORITY_OR_OTHER||Adjusted mean difference|-31.0|STANDARD_ERROR_OF_MEAN|4.0|<|0.0001|TWO_SIDED|95.0|-38.9|-23.2||Model includes baseline fasting plasma glucose, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-23.2|-38.9|<0.0001
72539856|NCT01289990|144609482|SUPERIORITY_OR_OTHER||Adjusted mean difference|-24.3|STANDARD_ERROR_OF_MEAN|2.7|<|0.0001|TWO_SIDED|95.0|-29.7|-18.9||Model includes baseline fasting plasma glucose, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-18.9|-29.7|<0.0001
72539857|NCT01289990|144609482|SUPERIORITY_OR_OTHER||Adjusted mean difference|-27.3|STANDARD_ERROR_OF_MEAN|2.8|<|0.0001|TWO_SIDED|95.0|-32.7|-21.9||Model includes baseline fasting plasma glucose, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-21.9|-32.7|<0.0001
72539858|NCT01289990|144609482|SUPERIORITY_OR_OTHER||Adjusted mean difference|-27.8|STANDARD_ERROR_OF_MEAN|2.9|<|0.0001|TWO_SIDED|95.0|-33.6|-22.0||Model includes baseline fasting plasma glucose, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-22.0|-33.6|<0.0001
72539859|NCT01289990|144609482|SUPERIORITY_OR_OTHER||Adjusted mean difference|-28.7|STANDARD_ERROR_OF_MEAN|3.0|<|0.0001|TWO_SIDED|95.0|-34.5|-22.8||Model includes baseline fasting plasma glucose, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-22.8|-34.5|<0.0001
72539860|NCT01289990|144609483|SUPERIORITY_OR_OTHER||Adjusted mean difference|-31.7|STANDARD_ERROR_OF_MEAN|2.9|<|0.0001|TWO_SIDED|95.0|-37.4|-25.9||Model includes baseline fasting plasma glucose, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-25.9|-37.4|<0.0001
72539861|NCT01289990|144609483|SUPERIORITY_OR_OTHER||Adjusted mean difference|-34.9|STANDARD_ERROR_OF_MEAN|2.9|<|0.0001|TWO_SIDED|95.0|-40.7|-29.1||Model includes baseline fasting plasma glucose, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-29.1|-40.7|<0.0001
72575325|NCT01338870|144676546|SUPERIORITY_OR_OTHER||LS mean difference|0.1|STANDARD_ERROR_OF_MEAN|0.126||0.7854|TWO_SIDED|80.0|-0.06|0.26|||Mixed Models Analysis|||Week 8: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction, baseline-by-treatment interaction, baseline-by-treatment-by-time interaction as the covariates, time was repeated for participant.||0.26|-0.06|0.7854
72539862|NCT01289990|144609483|SUPERIORITY_OR_OTHER||Adjusted mean difference|-16.3|STANDARD_ERROR_OF_MEAN|3.0|<|0.0001|TWO_SIDED|95.0|-22.1|-10.5||Model includes baseline fasting plasma glucose, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-10.5|-22.1|<0.0001
72539863|NCT01289990|144609483|SUPERIORITY_OR_OTHER||Adjusted mean difference|-15.4|STANDARD_ERROR_OF_MEAN|3.0|<|0.0001|TWO_SIDED|95.0|-21.2|-9.6||Model includes baseline fasting plasma glucose, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-9.6|-21.2|<0.0001
72539864|NCT01289990|144609483|SUPERIORITY_OR_OTHER||Adjusted mean difference|-18.7|STANDARD_ERROR_OF_MEAN|3.0|<|0.0001|TWO_SIDED|95.0|-24.5|-12.8||Model includes baseline fasting plasma glucose, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-12.8|-24.5|<0.0001
72539865|NCT01289990|144609483|SUPERIORITY_OR_OTHER||Adjusted mean difference|-23.3|STANDARD_ERROR_OF_MEAN|4.1|<|0.0001|TWO_SIDED|95.0|-31.4|-15.3||Model includes baseline fasting plasma glucose, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-15.3|-31.4|<0.0001
72539866|NCT01289990|144609483|SUPERIORITY_OR_OTHER||Adjusted mean difference|-27.4|STANDARD_ERROR_OF_MEAN|4.1|<|0.0001|TWO_SIDED|95.0|-35.4|-19.4||Model includes baseline fasting plasma glucose, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-19.4|-35.4|<0.0001
72539867|NCT01289990|144609483|SUPERIORITY_OR_OTHER||Adjusted mean difference|-25.1|STANDARD_ERROR_OF_MEAN|2.8|<|0.0001|TWO_SIDED|95.0|-30.5|-19.6||Model includes baseline fasting plasma glucose, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-19.6|-30.5|<0.0001
72539868|NCT01289990|144609483|SUPERIORITY_OR_OTHER||Adjusted mean difference|-31.4|STANDARD_ERROR_OF_MEAN|2.8|<|0.0001|TWO_SIDED|95.0|-36.9|-25.9||Model includes baseline fasting plasma glucose, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-25.9|-36.9|<0.0001
72539869|NCT01289990|144609483|SUPERIORITY_OR_OTHER||Adjusted mean difference|-31.0|STANDARD_ERROR_OF_MEAN|3.1|<|0.0001|TWO_SIDED|95.0|-37.0|-24.9||Model includes baseline fasting plasma glucose, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-24.9|-37.0|<0.0001
72539870|NCT01289990|144609483|SUPERIORITY_OR_OTHER||Adjusted mean difference|-31.8|STANDARD_ERROR_OF_MEAN|3.1|<|0.0001|TWO_SIDED|95.0|-37.9|-25.7||Model includes baseline fasting plasma glucose, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-25.7|-37.9|<0.0001
72539871|NCT01488071|144609499|NON_INFERIORITY_OR_EQUIVALENCE|"Mixed model for repeated measurements (MMRM), using all available data, with a freely varying mean and covariance structures and with treatment, week, and site group as fixed factors and the baseline score as a covariate. The model also included interaction between week and baseline score, as well as interaction between week and treatment.~Non-inferiority, upper limit of Confidence Interval should not exceed 2."|Mean Difference (Final Values)|-2.16|STANDARD_ERROR_OF_MEAN|0.69||0.0018|TWO_SIDED|95.0|-3.51|-0.81||Under established non-inferiority the p-value is not adjusted.|Mixed Models Analysis|MMRM||||-0.81|-3.51|0.0018
72539872|NCT01488071|144609500|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.03|STANDARD_ERROR_OF_MEAN|0.72||0.0054|TWO_SIDED|95.0|-3.45|-0.6||No adjustments for multiple comparisons were made.|Mixed Models Analysis|The same MMRM methodology as for the primary endpoint was used.||||-0.60|-3.45|0.0054
72539873|NCT01488071|144609501|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.89|STANDARD_ERROR_OF_MEAN|0.56||0.0008|TWO_SIDED|95.0|-2.98|-0.8||No adjustments for multiple comparisons were made.|Mixed Models Analysis|The same MMRM methodology as for the primary endpoint was used.||||-0.80|-2.98|0.0008
72539874|NCT01488071|144609502|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.93|STANDARD_ERROR_OF_MEAN|0.57||0.0007|TWO_SIDED|95.0|-3.04|-0.81||No adjustments for multiple comparisons were made.|Mixed Models Analysis|The same MMRM methodology as for the primary endpoint was used.||||-0.81|-3.04|0.0007
72575326|NCT01338870|144676546|SUPERIORITY_OR_OTHER||LS mean difference|-0.18|STANDARD_ERROR_OF_MEAN|0.123||0.0778|TWO_SIDED|80.0|-0.33|-0.02|||Mixed Models Analysis|||Week 8: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction, baseline-by-treatment interaction, baseline-by-treatment-by-time interaction as the covariates, time was repeated for participant.||-0.02|-0.33|0.0778
72575327|NCT01338870|144676546|SUPERIORITY_OR_OTHER||LS mean difference|-0.31|STANDARD_ERROR_OF_MEAN|0.122||0.0065|TWO_SIDED|80.0|-0.46|-0.15|||Mixed Models Analysis|||Week 8: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction, baseline-by-treatment interaction, baseline-by-treatment-by-time interaction as the covariates, time was repeated for participant.||-0.15|-0.46|0.0065
72575328|NCT01338870|144676546|SUPERIORITY_OR_OTHER||LS mean difference|-0.37|STANDARD_ERROR_OF_MEAN|0.119||0.0011|TWO_SIDED|80.0|-0.52|-0.21|||Mixed Models Analysis|||Week 8: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction, baseline-by-treatment interaction, baseline-by-treatment-by-time interaction as the covariates, time was repeated for participant.||-0.21|-0.52|0.0011
72575329|NCT01338870|144676546|SUPERIORITY_OR_OTHER||LS mean difference|-0.37|STANDARD_ERROR_OF_MEAN|0.121||0.0013|TWO_SIDED|80.0|-0.52|-0.21|||Mixed Models Analysis|||Week 8: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction, baseline-by-treatment interaction, baseline-by-treatment-by-time interaction as the covariates, time was repeated for participant.||-0.21|-0.52|0.0013
72627448|NCT00485173|144783774|SUPERIORITY_OR_OTHER|||||||0.031||95.0||||P-value was one-sided, adjusted from ANCOVA with the propensity score as the covariate.|ANCOVA|||||||0.031
72539875|NCT01488071|144609503|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.1||0.0023|TWO_SIDED|95.0|-0.48|-0.11||No adjustments for multiple comparisons were made.|Mixed Models Analysis|The same MMRM methodology as for the primary endpoint was used.||||-0.11|-0.48|0.0023
72539876|NCT01488071|144609504|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.27|STANDARD_ERROR_OF_MEAN|0.1||0.0075|TWO_SIDED|95.0|-0.47|-0.07||No adjustments for multiple comparisons were made.|Mixed Models Analysis|The same MMRM methodology as for the primary endpoint was used.||||-0.07|-0.47|0.0075
72539877|NCT01488071|144609505|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.25|STANDARD_ERROR_OF_MEAN|0.09||0.0048|TWO_SIDED|95.0|-0.42|-0.08||No adjustments for multiple comparisons were made.|Mixed Models Analysis|The same MMRM methodology as for the primary endpoint was used.||||-0.08|-0.42|0.0048
72539878|NCT01488071|144609506|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.25|STANDARD_ERROR_OF_MEAN|0.09||0.0055|TWO_SIDED|95.0|-0.42|-0.07||No adjustments for multiple comparisons were made.|Mixed Models Analysis|The same MMRM methodology as for the primary endpoint was used.||||-0.07|-0.42|0.0055
72627449|NCT00485173|144783775|NON_INFERIORITY_OR_EQUIVALENCE|The predefined non-inferiority margin was 0.10.||||||0.001||95.0||||P-value was one-sided from random samplings, based on logistic regression model by using propensity score as a covariate.|Regression, Logistic|||||||0.001
72539879|NCT01488071|144609507|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.81||||0.0012|TWO_SIDED|95.0|1.26|2.6||Wald's Test. No adjustments for multiple comparisons were made.|Regression, Logistic|||||2.60|1.26|0.0012
72539880|NCT01488071|144609508|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.83||||0.0014|TWO_SIDED|95.0|1.26|2.65||Wald's Test. No adjustments for multiple comparisons were made.|Regression, Logistic|||||2.65|1.26|0.0014
72539881|NCT01488071|144609509|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.72||||0.0054|TWO_SIDED|95.0|1.17|2.52||Wald's Test. No adjustments for multiple comparisons were made.|Regression, Logistic|||||2.52|1.17|0.0054
72627450|NCT00485173|144783775|SUPERIORITY_OR_OTHER|||||||0.414||95.0||||P-value was one-sided, obtained from logistic regression model by using propensity score as a covariate.|Regression, Logistic|||Superiority analysis was performed if non-inferiority was demonstrated.||||0.414
72627451|NCT00485173|144783776|SUPERIORITY_OR_OTHER|||||||0.03||95.0||||P-value was one-sided, adjusted from ANCOVA with the propensity score as the covariate.|ANCOVA|||||||0.030
72627452|NCT00485173|144783777|NON_INFERIORITY_OR_EQUIVALENCE|The predefined non-inferiority margin was 0.10.|||||<|0.001||95.0||||P-value was one-sided from random samplings, based on logistic regression model by using propensity score as a covariate.|Regression, Logistic|||||||<0.001
72627453|NCT00485173|144783777|SUPERIORITY_OR_OTHER|||||||0.017||95.0||||P-value was one-sided, obtained from logistic regression model by using propensity score as a covariate.|Regression, Logistic|||Superiority analysis was performed if non-inferiority was demonstrated.||||0.017
72627454|NCT00485173|144783778|SUPERIORITY_OR_OTHER|||||||0.189||95.0||||P-value was one-sided, adjusted from ANCOVA with the propensity score as the covariate.|ANCOVA|||||||0.189
72627455|NCT00485173|144783779|NON_INFERIORITY_OR_EQUIVALENCE|The predefined non-inferiority margin was 0.10.||||||0.003||95.0||||P-value was one-sided from random samplings, based on logistic regression model by using propensity score as a covariate.|Regression, Logistic|||||||0.003
72627456|NCT00485173|144783779|SUPERIORITY_OR_OTHER|||||||0.466||95.0||||P-value was one-sided, obtained from logistic regression model by using propensity score as a covariate.|Regression, Logistic|||Superiority analysis was performed if non-inferiority was demonstrated.||||0.466
72539882|NCT01488071|144609510|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.01||||0.0002|TWO_SIDED|95.0|1.39|2.9||Wald's Test. No adjustments for multiple comparisons were made.|Regression, Logistic|||||2.90|1.39|0.0002
72539883|NCT01488071|144609511|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.22|STANDARD_ERROR_OF_MEAN|0.72||0.0021|TWO_SIDED|95.0|-3.63|-0.81||No adjustments for multiple comparisons were made.|Mixed Models Analysis|The same MMRM methodology as for the primary endpoint was used.||||-0.81|-3.63|0.0021
72539884|NCT01488071|144609512|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.75|STANDARD_ERROR_OF_MEAN|0.75||0.0209|TWO_SIDED|95.0|-3.23|-0.27||No adjustments for multiple comparisons were made.|Mixed Models Analysis|The same MMRM methodology as for the primary endpoint was used.||||-0.27|-3.23|0.0209
72539885|NCT02524665|144609524|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.67|STANDARD_DEVIATION|61.97||0.0769||95.0||||The assumption of normality was verified using a Shapiro-Wilk Test. If the assumption of normality was rejected (at the 0.01 level), a non-parametric method (Wilcoxon signed-rank test) was used|Wilcoxon signed-rank test||Comparison of inflammatory lesion counts between MAXCLARITY II and Murad at Week 8.|||||0.0769
72539886|NCT02524665|144609524|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.77|STANDARD_DEVIATION|33.73||0.6698||95.0||||The assumption of normality was verified using a Shapiro-Wilk Test. If the assumption of normality was rejected (at the 0.01 level), a non-parametric method (Wilcoxon signed-rank test) was used.|Wilcoxon signed-rank test||Comparison of non-inflammatory lesion counts between MAXCLARITY II and Murad at Week 8.|||||0.6698
72539887|NCT02524665|144609524|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.66|STANDARD_DEVIATION|17.59||0.6854||95.0||||Percent change from baseline were analyzed using the individual differences between both sides of the face at an alpha level of 0.05 using paired t-tests.|t-test, 2 sided||Comparison of total lesion counts between MAXCLARITY II and Murad at Week 8.|||||0.6854
72539888|NCT02524665|144609525|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.1|STANDARD_DEVIATION|74.55||0.5031||95.0||||The assumption of normality was verified using a Shapiro-Wilk Test. If the assumption of normality was rejected (at the 0.01 level), a non-parametric method (Wilcoxon signed-rank test) was used.|Wilcoxon signed-rank test||Comparison of percent change inflammatory lesion counts between MAXCLARITY II and Murad at Week 1.|||||0.5031
72539889|NCT02524665|144609525|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-29.11|STANDARD_DEVIATION|99.76||0.2464||95.0||||Percent change from baseline were analyzed using the individual differences between both sides of the face at an alpha level of 0.05 using paired t-tests.|t-test, 2 sided||Comparison of percent change inflammatory lesion counts between MAXCLARITY II and Murad at Week 2.|||||0.2464
72627457|NCT00485173|144783780|NON_INFERIORITY_OR_EQUIVALENCE|The predefined non-inferiority margin was 0.10.|||||<|0.001||95.0||||P-value was one-sided from random samplings, based on logistic regression model by using propensity score as a covariate.|Regression, Logistic|||||||<0.001
72627458|NCT00485173|144783780|SUPERIORITY_OR_OTHER|||||||0.133||95.0||||P-value was one-sided, obtained from logistic regression model by using propensity score as a covariate.|Regression, Logistic|||Superiority analysis was performed if non-inferiority was demonstrated.||||0.133
72627459|NCT00485173|144783781|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value was two-sided, adjusted from ANCOVA with the propensity score as the covariate.|ANCOVA|||||||<0.001
72627460|NCT00485173|144783782|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value was two-sided, adjusted from ANCOVA with the propensity score as the covariate.|ANCOVA|||||||<0.001
72627461|NCT00485173|144783783|SUPERIORITY_OR_OTHER|||||||0.341||95.0||||P-value was two-sided, adjusted from ANCOVA with the propensity score as the covariate.|ANCOVA|||||||0.341
72627462|NCT00485173|144783784|SUPERIORITY_OR_OTHER|||||||0.479||95.0||||P-value was two-sided, obtained from Cox regression and adjusted with propensity scores.|Regression, Cox|||||||0.479
72627463|NCT00485173|144783785|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value was from logistic regression model by using propensity score and any ossification 'Yes/No' at preop as the covariates.|Regression, Logistic|||Statistical analysis at 24 months postoperation.||||<0.001
72627464|NCT03366454|144783820|OTHER||AUC|0.6692|STANDARD_ERROR_OF_MEAN|0.05322||0.0048|TWO_SIDED|95.0|0.5649|0.7735|||ROC Curve Analysis|||ROC curve analysis was performed to evaluate outcome. The Area Under the Curve (AUC) was calculated along with a 95% confidence interval and statistical significance (p-value)||0.7735|0.5649|0.0048
72539890|NCT02524665|144609525|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.03|STANDARD_DEVIATION|65.22||0.8894||95.0||||The assumption of normality was verified using a Shapiro-Wilk Test. If the assumption of normality was rejected (at the 0.01 level), a non-parametric method (Wilcoxon signed-rank test) was used.|Wilcoxon signed-rank test||Comparison of percent change inflammatory lesion counts between MAXCLARITY II and Murad at Week 4.|||||0.8894
72539891|NCT02524665|144609525|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.98|STANDARD_ERROR_OF_MEAN|46.04||0.6722||95.0||||The assumption of normality was verified using a Shapiro-Wilk Test. If the assumption of normality was rejected (at the 0.01 level), a non-parametric method (Wilcoxon signed-rank test) was used.|Wilcoxon signed-rank test||Comparison of percent change non-inflammatory lesion counts between MAXCLARITY II and Murad at Week 1.|||||0.6722
72539892|NCT02524665|144609525|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.99|STANDARD_DEVIATION|39.59||0.3352||95.0||||Percent change from baseline were analyzed using the individual differences between both sides of the face at an alpha level of 0.05 using paired t-tests.|t-test, 2 sided||Comparison of percent change non-inflammatory lesion counts between MAXCLARITY II and Murad at Week 2.|||||0.3352
72539893|NCT02524665|144609525|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.41|STANDARD_DEVIATION|35.46||0.9323||95.0||||The assumption of normality was verified using a Shapiro-Wilk Test. If the assumption of normality was rejected (at the 0.01 level), a non-parametric method (Wilcoxon signed-rank test) was used.|Wilcoxon signed-rank test||Comparison of percent change non-inflammatory lesion counts between MAXCLARITY II and Murad at Week 4.|||||0.9323
72539894|NCT02524665|144609525|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.72|STANDARD_DEVIATION|26.05||0.3513||95.0||||Percent change from baseline were analyzed using the individual differences between both sides of the face at an alpha level of 0.05 using paired t-tests.|t-test, 2 sided||Comparison of percent change total lesion counts between MAXCLARITY II and Murad at Week 1.|||||0.3513
72539895|NCT02524665|144609525|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.22|STANDARD_DEVIATION|22.97||0.8199||95.0||||Percent change from baseline were analyzed using the individual differences between both sides of the face at an alpha level of 0.05 using paired t-tests.|t-test, 2 sided||Comparison of percent change total lesion counts between MAXCLARITY II and Murad at Week 2.|||||0.8199
72539896|NCT02524665|144609525|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_DEVIATION|17.83||0.9616||95.0||||Percent change from baseline were analyzed using the individual differences between both sides of the face at an alpha level of 0.05 using paired t-tests.|t-test, 2 sided||Comparison of percent change total lesion counts between MAXCLARITY II and Murad at Week 4.|||||0.9616
72539897|NCT02524665|144609526|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.05|STANDARD_DEVIATION|0.23||1||95.0|||||Wilcoxon signed-rank test||Comparison of ISGA score between MAXCLARITY II and Murad at Week 1|||||1.0000
72539898|NCT02524665|144609526|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.11|STANDARD_DEVIATION|0.66||0.75||95.0|||||Wilcoxon signed-rank test||Comparison of ISGA score between MAXCLARITY II and Murad at Week 2.|||||0.7500
72539899|NCT02524665|144609526|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.11|STANDARD_DEVIATION|0.74||0.7539||95.0|||||Wilcoxon signed-rank test||Comparison of ISGA score between MAXCLARITY II and Murad at Week 4.|||||0.7539
72539900|NCT02524665|144609526|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.26|STANDARD_DEVIATION|0.87||0.3071||95.0|||||Wilcoxon signed-rank test||Comparison of ISGA score between MAXCLARITY II and Murad at Week 8|||||0.3071
72539901|NCT02524665|144609527|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.16|STANDARD_DEVIATION|0.5||0.5||95.0|||||Wilcoxon signed-rank test||Comparison of Erythema score between MAXCLARITY II and Murad at Week 1.|||||0.5000
72539902|NCT02524665|144609527|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.05|STANDARD_DEVIATION|0.52||1||95.0|||||Wilcoxon signed-rank test||Comparison of Erythema score between MAXCLARITY II and Murad at Week 2.|||||1.0000
72539903|NCT02524665|144609527|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.05|STANDARD_DEVIATION|0.23||1||95.0|||||Wilcoxon signed-rank test||Comparison of Erythema score between MAXCLARITY II and Murad at Week 4.|||||1.0000
72539904|NCT02524665|144609527|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_DEVIATION|0.0||0||95.0||||The value is mentioned as '0', as no P-value generated.|Wilcoxon signed-rank test||Comparison of Erythema score between MAXCLARITY II and Murad at Week 8.|||||0
72539905|NCT02524665|144609527|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.11|STANDARD_DEVIATION|0.74||1||95.0|||||Wilcoxon signed-rank test||Comparison of Dryness score between MAXCLARITY II and Murad at Week 1.|||||1.0000
72539906|NCT02524665|144609527|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_DEVIATION|0.0||0||95.0||||The value is mentioned as '0', as no P-value generated.|Wilcoxon signed-rank test||Comparison of Dryness score between MAXCLARITY II and Murad at Week 2.|||||0
72539907|NCT02524665|144609527|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_DEVIATION|0.0||0||95.0||||The value is mentioned as '0', as no P-value generated.|Wilcoxon signed-rank test||Comparison of Dryness score between MAXCLARITY II and Murad at Week 4.|||||0
72539908|NCT02524665|144609527|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.05|STANDARD_DEVIATION|0.23||1||95.0|||||Wilcoxon signed-rank test||Comparison of Dryness score between MAXCLARITY II and Murad at Week 8.|||||1.0000
72539909|NCT02524665|144609527|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.16|STANDARD_DEVIATION|0.69||1||95.0|||||Wilcoxon signed-rank test||Comparison of Peeling score between MAXCLARITY II and Murad at Week 1.|||||1.0000
72539910|NCT02524665|144609527|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_DEVIATION|0.0||0||95.0||||The value is mentioned as '0', as no P-value generated.|Wilcoxon signed-rank test||Comparison of Peeling score between MAXCLARITY II and Murad at Week 2.|||||0
72539911|NCT02524665|144609527|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_DEVIATION|0.0||0||95.0||||The value is mentioned as '0', as no P-value generated.|Wilcoxon signed-rank test||Comparison of Peeling score between MAXCLARITY II and Murad at Week 4.|||||0
72539912|NCT02524665|144609527|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.05|STANDARD_DEVIATION|0.23||1||95.0|||||Wilcoxon signed-rank test||Comparison of Peeling score between MAXCLARITY II and Murad at Week 8.|||||1.0000
72539913|NCT02524665|144609528|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.21|STANDARD_DEVIATION|0.63||0.5||95.0|||||Wilcoxon signed-rank test||Comparison of Redness score between MAXCLARITY II and Murad at Week 1.|||||0.5000
72539914|NCT02524665|144609528|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.16|STANDARD_DEVIATION|0.5||0.5||95.0|||||Wilcoxon signed-rank test||Comparison of Redness score between MAXCLARITY II and Murad at Week 2.|||||0.5000
72539915|NCT02524665|144609528|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.21|STANDARD_DEVIATION|0.92||1||95.0|||||Wilcoxon signed-rank test||Comparison of Redness score between MAXCLARITY II and Murad at Week 4.|||||1.0000
72575330|NCT01338870|144676548|SUPERIORITY_OR_OTHER||LS mean difference|-0.16|STANDARD_ERROR_OF_MEAN|0.272||0.5636|TWO_SIDED|95.0|-0.69|0.38|||Mixed Models Analysis|||Week 1: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.38|-0.69|0.5636
72575331|NCT01338870|144676548|SUPERIORITY_OR_OTHER||LS mean difference|0.19|STANDARD_ERROR_OF_MEAN|0.271||0.4889|TWO_SIDED|95.0|-0.35|0.72|||Mixed Models Analysis|||Week 1: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.72|-0.35|0.4889
72575332|NCT01338870|144676548|SUPERIORITY_OR_OTHER||LS mean difference|-0.15|STANDARD_ERROR_OF_MEAN|0.272||0.5849|TWO_SIDED|95.0|-0.68|0.39|||Mixed Models Analysis|||Week 1: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.39|-0.68|0.5849
72575333|NCT01338870|144676548|SUPERIORITY_OR_OTHER||LS mean difference|-0.18|STANDARD_ERROR_OF_MEAN|0.268||0.5104|TWO_SIDED|95.0|-0.7|0.35|||Mixed Models Analysis|||Week 1: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.35|-0.70|0.5104
72575334|NCT01338870|144676548|SUPERIORITY_OR_OTHER||LS mean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.269||0.264|TWO_SIDED|95.0|-0.83|0.23|||Mixed Models Analysis|||Week 1: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.23|-0.83|0.2640
72575335|NCT01338870|144676548|SUPERIORITY_OR_OTHER||LS mean difference|-0.71|STANDARD_ERROR_OF_MEAN|0.357||0.0464|TWO_SIDED|95.0|-1.42|-0.01|||Mixed Models Analysis|||Week 2: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||-0.01|-1.42|0.0464
72575336|NCT01338870|144676548|SUPERIORITY_OR_OTHER||LS mean difference|-0.13|STANDARD_ERROR_OF_MEAN|0.353||0.7107|TWO_SIDED|95.0|-0.83|0.56|||Mixed Models Analysis|||Week 2: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.56|-0.83|0.7107
72575337|NCT01338870|144676548|SUPERIORITY_OR_OTHER||LS mean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.352||0.1564|TWO_SIDED|95.0|-1.19|0.19|||Mixed Models Analysis|||Week 2: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.19|-1.19|0.1564
72575338|NCT01338870|144676548|SUPERIORITY_OR_OTHER||LS mean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.345||0.3834|TWO_SIDED|95.0|-0.98|0.38|||Mixed Models Analysis|||Week 2: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.38|-0.98|0.3834
72539916|NCT02524665|144609528|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.16|STANDARD_DEVIATION|0.69||1||95.0|||||Wilcoxon signed-rank test||Comparison of Redness score between MAXCLARITY II and Murad at Week 8.|||||1.0000
72539917|NCT02524665|144609528|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.11|STANDARD_DEVIATION|0.88||0.8125||95.0|||||Wilcoxon signed-rank test||Comparison of Dryness score between MAXCLARITY II and Murad at Week 1.|||||0.8125
72575339|NCT01338870|144676548|SUPERIORITY_OR_OTHER||LS mean difference|-0.53|STANDARD_ERROR_OF_MEAN|0.346||0.1279|TWO_SIDED|95.0|-1.21|0.15|||Mixed Models Analysis|||Week 2: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.15|-1.21|0.1279
72575340|NCT01338870|144676548|SUPERIORITY_OR_OTHER||LS mean difference|-0.39|STANDARD_ERROR_OF_MEAN|0.339||0.252|TWO_SIDED|95.0|-1.06|0.28|||Mixed Models Analysis|||Week 4: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.28|-1.06|0.2520
72575341|NCT01338870|144676548|SUPERIORITY_OR_OTHER||LS mean difference|0.37|STANDARD_ERROR_OF_MEAN|0.336||0.2772|TWO_SIDED|95.0|-0.3|1.03|||Mixed Models Analysis|||Week 4: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||1.03|-0.30|0.2772
72575342|NCT01338870|144676548|SUPERIORITY_OR_OTHER||LS mean difference|-0.13|STANDARD_ERROR_OF_MEAN|0.335||0.7038|TWO_SIDED|95.0|-0.79|0.53|||Mixed Models Analysis|||Week 4: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.53|-0.79|0.7038
72539918|NCT02524665|144609528|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.11|STANDARD_DEVIATION|0.94||0.5742||95.0|||||Wilcoxon signed-rank test||Comparison of Dryness score between MAXCLARITY II and Murad at Week 2.|||||0.5742
72539919|NCT02524665|144609528|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.26|STANDARD_DEVIATION|0.93||0.5||95.0|||||Wilcoxon signed-rank test||Comparison of Dryness score between MAXCLARITY II and Murad at Week 4.|||||0.5000
72409736|NCT01196871|144327956|OTHER|Geometric means for each treatment combination is obtained from the linear mixed effects model Log (parameter) = Intercept + ß\*Treatment + Error.|AUC0-t Ratio|1.025|||||TWO_SIDED|90.0|0.921|1.14|||||The ratios of the geometric means (combination/alone) and its 90% CI are obtained by exponentiating the least squares mean difference and its 90% CI of the natural log-transformed data.|Statistical Analysis of Stage 1 AUC0-t Data: Point estimates for the geometric means and their 90% CI are obtained by exponentiating the least squares mean and the lower and upper bounds of the 90% CI of the natural log-transformed data.||1.140|0.921|
72539920|NCT02524665|144609528|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.32|STANDARD_DEVIATION|0.82||0.25||95.0|||||Wilcoxon signed-rank test||Comparison of Dryness score between MAXCLARITY II and Murad at Week 8.|||||0.2500
72539921|NCT02524665|144609528|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.05|STANDARD_DEVIATION|0.62||1||95.0|||||Wilcoxon signed-rank test||Comparison of Burning score between MAXCLARITY II and Murad at Week 1.|||||1.0000
72539922|NCT02524665|144609528|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.11|STANDARD_DEVIATION|0.74||0.75||95.0|||||Wilcoxon signed-rank test||Comparison of Burning score between MAXCLARITY II and Murad at Week 2.|||||0.7500
72539923|NCT02524665|144609528|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.21|STANDARD_DEVIATION|0.98||0.75||95.0|||||Wilcoxon signed-rank test||Comparison of Burning score between MAXCLARITY II and Murad at Week 4.|||||0.7500
72539924|NCT02524665|144609528|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.26|STANDARD_DEVIATION|0.73||0.25||95.0|||||Wilcoxon signed-rank test||Comparison of Burning score between MAXCLARITY II and Murad at Week 8.|||||0.2500
72539925|NCT02524665|144609528|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.21|STANDARD_DEVIATION|0.54||0.25||95.0|||||Wilcoxon signed-rank test||Comparison of Itching score between MAXCLARITY II and Murad at Week 1.|||||0.2500
72539926|NCT02524665|144609528|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.11|STANDARD_DEVIATION|0.74||0.75||95.0|||||Wilcoxon signed-rank test||Comparison of Itching score between MAXCLARITY II and Murad at Week 2.|||||0.7500
72575343|NCT01338870|144676548|SUPERIORITY_OR_OTHER||LS mean difference|-0.42|STANDARD_ERROR_OF_MEAN|0.329||0.2031|TWO_SIDED|95.0|-1.07|0.23|||Mixed Models Analysis|||Week 4: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.23|-1.07|0.2031
72575344|NCT01338870|144676548|SUPERIORITY_OR_OTHER||LS mean difference|-0.13|STANDARD_ERROR_OF_MEAN|0.33||0.6948|TWO_SIDED|95.0|-0.78|0.52|||Mixed Models Analysis|||Week 4: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.52|-0.78|0.6948
72575345|NCT01338870|144676548|SUPERIORITY_OR_OTHER||LS mean difference|-0.24|STANDARD_ERROR_OF_MEAN|0.421||0.5691|TWO_SIDED|95.0|-1.07|0.59|||Mixed Models Analysis|||Week 8: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.59|-1.07|0.5691
72539927|NCT02524665|144609528|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.37|STANDARD_DEVIATION|1.01||0.25||95.0|||||Wilcoxon signed-rank test||Comparison of Itching score between MAXCLARITY II and Murad at Week 4.|||||0.2500
72539928|NCT02524665|144609528|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.32|STANDARD_DEVIATION|0.82||0.25||95.0|||||Wilcoxon signed-rank test||Comparison of Itching score between MAXCLARITY II and Murad at Week 8.|||||0.2500
72539929|NCT02524665|144609528|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.16|STANDARD_DEVIATION|0.5||0.5||95.0|||||Wilcoxon signed-rank test||Comparison of Scaling score between MAXCLARITY II and Murad at Week 1.|||||0.5000
72539930|NCT02524665|144609528|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_DEVIATION|0.0||0||95.0||||The value is mentioned as '0', as no P-value generated.|Wilcoxon signed-rank test||Comparison of Scaling score between MAXCLARITY II and Murad at Week 2.|||||0
72539931|NCT02524665|144609528|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.26|STANDARD_DEVIATION|0.93||0.5||95.0|||||Wilcoxon signed-rank test||Comparison of Scaling score between MAXCLARITY II and Murad at Week 4.|||||0.5000
72539932|NCT02524665|144609528|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.11|STANDARD_DEVIATION|0.81||1||95.0|||||Wilcoxon signed-rank test||Comparison of Scaling score between MAXCLARITY II and Murad at Week 8.|||||1.0000
72575346|NCT01338870|144676548|SUPERIORITY_OR_OTHER||LS mean difference|0.39|STANDARD_ERROR_OF_MEAN|0.415||0.3447|TWO_SIDED|95.0|-0.42|1.21|||Mixed Models Analysis|||Week 8: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||1.21|-0.42|0.3447
72575347|NCT01338870|144676548|SUPERIORITY_OR_OTHER||LS mean difference|-0.23|STANDARD_ERROR_OF_MEAN|0.413||0.5769|TWO_SIDED|95.0|-1.04|0.58|||Mixed Models Analysis|||Week 8: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.58|-1.04|0.5769
72539933|NCT02524665|144609529|SUPERIORITY_OR_OTHER|||||||1||95.0||||Comparison of one or more grade improvement between MAXCLARITY II and Murad at Week 1.|McNemar|||||||1.0000
72539934|NCT02524665|144609529|SUPERIORITY_OR_OTHER|||||||0||95.0||||The value is mentioned as '0', as no P-value generated. Comparison of two or more grade improvement between MAXCLARITY II and Murad at Week 1.|McNemar|||||||0
72539935|NCT02524665|144609529|SUPERIORITY_OR_OTHER|||||||0.5637||95.0||||Comparison of one or more grade improvement between MAXCLARITY II and Murad at Week 2.|McNemar|||||||0.5637
72539936|NCT02524665|144609529|SUPERIORITY_OR_OTHER|||||||1||95.0||||Comparison of two or more grade improvement between MAXCLARITY II and Murad at Week 2.|McNemar|||||||1.0000
72539937|NCT02524665|144609529|SUPERIORITY_OR_OTHER|||||||0.4795||95.0||||Comparison of one or more grade improvement between MAXCLARITY II and Murad at Week 4.|McNemar|||||||0.4795
72539938|NCT02524665|144609529|SUPERIORITY_OR_OTHER|||||||1||95.0||||Comparison of two or more grade improvement between MAXCLARITY II and Murad at Week 4.|McNemar|||||||1.0000
72539939|NCT02524665|144609529|SUPERIORITY_OR_OTHER|||||||0.3173||95.0||||Comparison of one or more grade improvement between MAXCLARITY II and Murad at Week 8.|McNemar|||||||0.3173
72539940|NCT02524665|144609529|SUPERIORITY_OR_OTHER|||||||0.1573||95.0||||Comparison of two or more grade improvement between MAXCLARITY II and Murad at Week 8.|McNemar|||||||0.1573
72539941|NCT04355767|144609583|SUPERIORITY|||||||||||||||||Analysis is of patients with a disease-progression event. The trial required a sample size of 900 patients to detect an absolute between-group difference of 10 percentage points (the minimum difference that we considered to be clinically important) with a power of 85%.|A Bayesian framework was used to calculate a risk difference of 1.9 percentage points (placebo group minus convalescent-plasma group) with a 95% credible interval of -6.0 to 9.8. The posterior probability of superiority was calculated to be 0.68. Efficacy was defined as a posterior probability of 0.975 or more that the proportion of patients with outcome events was higher in the placebo group.|||
72539942|NCT04355767|144609583|SUPERIORITY||Risk Difference (RD)|2.2|||||TWO_SIDED|95.0|-5.9|10.4|||||Risk difference after adjustment for age, sex, symptom duration.|Analysis is of patients with a disease-progression event.||10.4|-5.9|
72539943|NCT04355767|144609584|SUPERIORITY|||||||||||||||||Analysis is of patients with a disease-progression event.|A Bayesian framework was used to calculate a risk difference of 3.0 percentage points (placebo group minus convalescent-plasma group) with a 95% credible interval of -4.9 to 10.8. The posterior probability of superiority was calculated to be 0.76. Efficacy was defined as a posterior probability of 0.975 or more that the proportion of patients with outcome events was higher in the placebo group.|||
72539944|NCT04355767|144609586|OTHER||Hazard Ratio (HR)|0.9|||||TWO_SIDED|95.0|0.69|1.17||||||||1.17|0.69|
72539945|NCT04355767|144609587|OTHER||Mean Difference (Final Values)|0.3|||||TWO_SIDED|95.0|-0.4|1.1||||||||1.1|-0.4|
72539946|NCT02200614|144609593|SUPERIORITY||Hazard Ratio (HR)|0.413|||<|1e-06|TWO_SIDED|95.0|0.341|0.5|||Log Rank||Hazard ratio and 95% Confidence Interval (CI) was based on Cox Regression Model, stratified by Prostate-specific antigen doubling time (PSADT) (≤ 6 months vs. \> 6 months) and use of osteoclast-targeted therapy (No, Yes).|||0.500|0.341|<0.000001
72539947|NCT02200614|144609594|SUPERIORITY||Hazard Ratio (HR)|0.706||||0.04521|TWO_SIDED|95.0|0.501|0.994|||Log Rank||The hazard ratio and its 95% CI were based on Cox Regression Model, stratified by Prostate-specific antigen doubling time (PSADT) (≤ 6 months vs. \> 6 months) and use of osteoclast-targeted therapy (No, Yes).|||0.994|0.501|0.045210
72539948|NCT02200614|144609595|SUPERIORITY||Hazard Ratio (HR)|0.647||||8e-06|TWO_SIDED|95.0|0.533|0.785|||Log Rank||The hazard ratio and its 95% CI were based on Cox Regression Model, stratified by Prostate-specific antigen doubling time (PSADT) (≤ 6 months vs. \> 6 months) and use of osteoclast-targeted therapy (No, Yes).|||0.785|0.533|0.000008
72539949|NCT02200614|144609596|SUPERIORITY||Hazard Ratio (HR)|0.433|||<|1e-06|TWO_SIDED|95.0|0.314|0.595|||Log Rank||The hazard ratio and its 95% CI were based on Cox Regression Model, stratified by Prostate-specific antigen doubling time (PSADT) (≤ 6 months vs. \> 6 months) and use of osteoclast-targeted therapy (No, Yes).|||0.595|0.314|<0.000001
72539950|NCT02200614|144609597|SUPERIORITY||Hazard Ratio (HR)|0.428||||0.011262|TWO_SIDED|95.0|0.218|0.842|||Log Rank||The hazard ratio and its 95% CI were based on Cox Regression Model, stratified by Prostate-specific antigen doubling time (PSADT) (≤ 6 months vs. \> 6 months) and use of osteoclast-targeted therapy (No, Yes).|||0.842|0.218|0.011262
72539951|NCT02200614|144609598|SUPERIORITY||Hazard Ratio (HR)|0.685||||0.003048|TWO_SIDED|95.0|0.533|0.881|||Log Rank||The hazard ratio and its 95% CI were based on Cox Regression Model, stratified by Prostate-specific antigen doubling time (PSADT) (≤ 6 months vs. \> 6 months) and use of osteoclast-targeted therapy (No, Yes).|||0.881|0.533|0.003048
72539952|NCT02200614|144609599|SUPERIORITY||Hazard Ratio (HR)|0.647||||8e-06|TWO_SIDED|95.0|0.533|0.785|||Log Rank||The hazard ratio and its 95% CI were based on Cox Regression Model, stratified by Prostate-specific antigen doubling time (PSADT) (≤ 6 months vs. \> 6 months) and use of osteoclast-targeted therapy (No, Yes).|||0.785|0.533|0.000008
72539953|NCT02200614|144609600|SUPERIORITY||Hazard Ratio (HR)|0.579||||4.4e-05|TWO_SIDED|95.0|0.444|0.755|||Log Rank||The hazard ratio and its 95% CI were based on Cox Regression Model, stratified by Prostate-specific antigen doubling time (PSADT) (≤ 6 months vs. \> 6 months) and use of osteoclast-targeted therapy (No, Yes).|||0.755|0.444|0.000044
72539954|NCT02200614|144609601|SUPERIORITY||Hazard Ratio (HR)|0.484||||0.005294|TWO_SIDED|95.0|0.287|0.815|||Log Rank||The hazard ratio and its 95% CI were based on Cox Regression Model, stratified by Prostate-specific antigen doubling time (PSADT) (≤ 6 months vs. \> 6 months) and use of osteoclast-targeted therapy (No, Yes).|||0.815|0.287|0.005294
72539955|NCT00301873|144609604|SUPERIORITY_OR_OTHER||Slope|-0.107|STANDARD_ERROR_OF_MEAN|0.0855||0.2212||95.0||||The p-value is a test of whether the slope of the regression line is non-zero.|Regression, Linear|The linear regression assesses the relationship between baseline baseline steroid use and BMD change at 6 months (outcome).||59 patients were accrued to the study. The 27 patients with follow-up at 6 months are included in an analysis to assess the association between baseline steroid use and bone mass density at 6 months using linear regression.||||.2212
72539956|NCT00301873|144609604|SUPERIORITY_OR_OTHER||Slope|0.2357|STANDARD_ERROR_OF_MEAN|0.1091||0.0413||95.0||||this p-value is at test of whether the slope of the regression line is non-zero.|Regression, Linear|The linear regression assesses the relationship between anticonvulsant use and BMD change at 6 months (outcome).||59 patients were accrued to the study. The 27 patients with follow-up at 6 months are included in an analysis to assess the association between baseline anticonvulsant use and bone mass density at 6 months using linear regression||||.0413
72409737|NCT01196871|144327956|OTHER|Geometric means for each treatment combination is obtained from the linear mixed effects mode Log (parameter) = Intercept + ß\*Treatment + Error.|AUC0-t Ratio|1.256|||||TWO_SIDED|90.0|1.026|1.538|||||The ratios of the geometric means (combination/alone) and its 90% CI are obtained by exponentiating the least squares mean difference and its 90% CI of the natural log-transformed data.|Statistical Analysis of Stage 2 AUC0-t Data: Point estimates for the geometric means and their 90% CI are obtained by exponentiating the least squares mean and the lower and upper bounds of the 90% CI of the natural log-transformed data.||1.538|1.026|
72409738|NCT01196871|144327958|OTHER|Geometric means for each treatment combination is obtained from the linear mixed effects model Log (parameter) = Intercept + ß\*Treatment + Error.|Cmax Ratio|1.034|||||TWO_SIDED|90.0|0.929|1.152|||||The ratios of the geometric means (combination/alone) and its 90% CI are obtained by exponentiating the least squares mean difference and its 90% CI of the natural log-transformed data.|Statistical Analysis of Stage 1 Cmax Data: Point estimates for the geometric means and their 90% CI are obtained by exponentiating the least squares mean and the lower and upper bounds of the 90% CI of the natural log-transformed data.||1.152|0.929|
72409739|NCT01196871|144327958|OTHER|Geometric means for each treatment combination is obtained from the linear mixed effects model Log (parameter) = Intercept + ß\*Treatment + Error.|Cmax Ratio|1.063|||||TWO_SIDED|90.0|0.972|1.164|||||The ratios of the geometric means (combination/alone) and its 90% CI are obtained by exponentiating the least squares mean difference and its 90% CI of the natural log-transformed data.|Statistical Analysis of Stage 2 Cmax Data: Point estimates for the geometric means and their 90% CI are obtained by exponentiating the least squares mean and the lower and upper bounds of the 90% CI of the natural log-transformed data.||1.164|0.972|
72409740|NCT01196871|144327960|OTHER|Geometric means for each treatment combination is obtained from the linear mixed effects model Log (parameter) = Intercept + ß\*Treatment + Error.|AUC0-t Ratio|1.059|||||TWO_SIDED|90.0|0.818|1.371|||||The ratios of the geometric means (combination/alone) and its 90% CI are obtained by exponentiating the least squares mean difference and its 90% CI of the natural log-transformed data.|Statistical Analysis of Stage 1 AUC0-t Data: Point estimates for the geometric means and their 90% CI are obtained by exponentiating the least squares mean and the lower and upper bounds of the 90% CI of the natural log-transformed data.||1.371|0.818|
72409741|NCT01196871|144327960|OTHER|Geometric means for each treatment combination is obtained from the linear mixed effects model Log (parameter) = Intercept + ß\*Treatment + Error.|AUCinfinity Ratio|1.052|||||TWO_SIDED|90.0|0.807|1.371|||||The ratios of the geometric means (combination/alone) and its 90% CI are obtained by exponentiating the least squares mean difference and its 90% CI of the natural log-transformed data.|Statistical Analysis of Stage 1 AUCinfinity Data: Point estimates for the geometric means and their 90% CI are obtained by exponentiating the least squares mean and the lower and upper bounds of the 90% CI of the natural log-transformed data.||1.371|0.807|
72409742|NCT01196871|144327961|OTHER|Geometric means for each treatment combination is obtained from the linear mixed effects model Log (parameter) = Intercept + ß\*Treatment + Error.|Cmax Ratio|0.997|||||TWO_SIDED|90.0|0.791|1.259|||||The ratios of the geometric means (combination/alone) and its 90% CI are obtained by exponentiating the least squares mean difference and its 90% CI of the natural log-transformed data.|Statistical Analysis of Stage 1 Cmax Data: Point estimates for the geometric means and their 90% CI are obtained by exponentiating the least squares mean and the lower and upper bounds of the 90% CI of the natural log-transformed data.||1.259|0.791|
72409743|NCT03062891|144327976|SUPERIORITY||Slope|0.54||||0.572|TWO_SIDED|95.0|-1.33|2.4|||Regression, Linear|||This analysis looked at the interaction between baseline anxiety symptoms and group on the change in insomnia symptoms across the intervention. The results of the interaction are reported here.||2.40|-1.33|.572
72409744|NCT03062891|144327977|SUPERIORITY||Slope|0.08||||0.934|TWO_SIDED|95.0|-1.82|1.98|||Regression, Linear|||This analysis looked at the interaction between baseline depression symptoms and group on the change in insomnia symptoms across the intervention. The results of the interaction are reported here.||1.98|-1.82|.934
72409745|NCT03062891|144327978|SUPERIORITY||Slope|1.07||||0.253|TWO_SIDED|95.0|-0.76|2.89|||Regression, Linear|||This analysis looked at the interaction between attentional problems and group on the change in insomnia symptoms across the intervention. The results of the interaction are reported here.||2.89|-0.76|.253
72539957|NCT00301873|144609604|SUPERIORITY_OR_OTHER||Slope|-0.232|STANDARD_ERROR_OF_MEAN|0.1029||0.0418||95.0||||this p-value is at test of whether the slope of the regression line is non-zero.|Regression, Linear|The linear regression assesses the relationship between baseline steroid use and BMD change at 12 months (outcome).||59 patients were accrued to the study. The 19 patients with follow-up at 12 months are included in an analysis to assess the association between baseline steroid use and bone mass density at 12 months using linear regression||||.0418
72539958|NCT00301873|144609604|SUPERIORITY_OR_OTHER||Slope|0.2123|STANDARD_ERROR_OF_MEAN|0.1209||0.1026||95.0||||the p-value is a test of whether the slope ofl the regression line is non-zero.|Regression, Linear|The linear regression assesses the relationship between anticonvulsant use and BMD change at 12 months.||59 patients were accrued to the study. The 19 patients with follow-up at 12 months are included in an analysis to assess the association between baseline anti-convulsant use and bone mass density at 12 months using linear regression||||.1026
72539959|NCT03302299|144609641|SUPERIORITY||Odds Ratio (OR)|1.59|||<|0.01|TWO_SIDED|95.0|0.94|2.71||global p-value for 3-category alcohol use variable in a multivariable generalized estimating equation logistic regression model of sub-optimal INH adherence.|Regression, Logistic||OR for participants with moderate alcohol use in the prior 3 months, compared to those with no alcohol use in the prior 3 months.|||2.71|0.94|<0.01
72539960|NCT03302299|144609641|SUPERIORITY||Odds Ratio (OR)|2.78|||<|0.01|TWO_SIDED|95.0|1.62|4.76||global p-value for 3-category alcohol use variable in a multivariable generalized estimating equation logistic regression model of sub-optimal INH adherence.|Regression, Logistic||OR is for participants with unhealthy alcohol use in the prior 3 months, compared to those with no alcohol use in the prior 3 months.|||4.76|1.62|<0.01
72539961|NCT04318535|144609647|EQUIVALENCE|Bioequivalence was to be determined if the 90% confidence interval of the geometric least square mean ratio of Cmax falls within the 0.80-1.25 range.|Ratio of geometric least square mean|1.157|||||TWO_SIDED|90.0|1.103|1.213|||||T1 versus R was the primary interest of comparison for this outcome measure.|||1.213|1.103|
72409746|NCT03062891|144327979|SUPERIORITY||Slope|1.2||||0.215|TWO_SIDED|95.0|-0.7|3.1|||Regression, Linear|||This analysis looked at the interaction between baseline paranois and group on the change in insomnia symptoms across the intervention. The results of the interaction are reported here.||3.10|-0.70|.215
72409747|NCT03062891|144327979|SUPERIORITY||Slope|1.14||||0.254|TWO_SIDED|95.0|-0.83|3.11|||Regression, Linear|||This analysis looked at the interaction between baseline hallucinations and group on the change in insomnia symptoms across the intervention. The results of the interaction are reported here.||3.11|-0.83|.254
72409748|NCT03062891|144327979|SUPERIORITY||Slope|-0.27||||0.778|TWO_SIDED|95.0|-2.13|1.59|||Regression, Linear|||This analysis looked at the interaction between baseline cognitive disorganization and group on the change in insomnia symptoms across the intervention. The results of the interaction are reported here.||1.59|-2.13|.778
72539962|NCT04318535|144609648|EQUIVALENCE|Bioequivalence was to be determined if the 90% confidence interval of the geometric least square mean ratio of AUC(0-t) falls within the 0.80-1.25 range.|Ratio of geometric least square mean|1.032|||||TWO_SIDED|90.0|0.974|1.094|||||T1 versus R was the primary interest of comparison for this outcome measure.|||1.094|0.974|
72539963|NCT04318535|144609649|EQUIVALENCE|Bioequivalence was to be determined if the 90% confidence interval of the geometric least square mean ratio of AUC(0-inf) falls within the 0.80-1.25 range.|Ratio of geometric least square mean|1.03|||||TWO_SIDED|90.0|0.971|1.093|||||T1 versus R was the primary interest of comparison for this outcome measure.|||1.093|0.971|
72539964|NCT01901146|144609659|EQUIVALENCE|The clinical equivalence between ABP 980 and trastuzumab was first evaluated by comparing the 2-sided 90% CI of the risk difference of pCR between ABP 980 and trastuzumab with a fixed margin of (-13%, 13%).|Risk Difference (RD)|7.3||||0.0508|TWO_SIDED|90.0|1.2|13.4|||Generalized linear model|Generalized linear model adjusted for the randomization stratification factors.||The clinical equivalence between ABP 980 and trastuzumab was first evaluated by comparing the 2-sided 90% confidence interval (CI) of the Risk Difference (RD; ABP 980 - Trastuzumab) of pCR between ABP 980 and trastuzumab with a fixed margin of (-13%, 13%), estimated using a generalized linear model adjusted for stratification factors tumor (T)-stage, nodal status, hormone receptor status, planned paclitaxel dosing schedule, and geographic region.||13.4|1.2|0.0508
72539965|NCT01901146|144609659|EQUIVALENCE|If the test of equivalence on the RD of pCR was successful, then equivalence was tested on the risk ratio of pCR at a 2-sided significance level of 0.05 by comparing the 2-sided 90% CI of the RR of pCR between ABP 980 and trastuzumab estimated using a generalized linear model adjusted for stratification factors, with the margin of (0.7586, 1/0.7586). If the test of equivalence on the RD was not successful, the RR of pCR and 90% CI were considered to be descriptive.|Risk Ratio (RR)|1.1877||||0.043|TWO_SIDED|90.0|1.0327|1.366|||Generalized linear model|Generalized linear model adjusted for the randomization stratification factors.||If the test of equivalence on the RD of pCR was successful, then equivalence was tested on the Risk Ratio (RR; ABP 980 / Trastuzumab) of pCR at a 2-sided significance level of 0.05 by comparing the 2-sided 90% CI of the RR of pCR between ABP 980 and trastuzumab, estimated using a generalized linear model adjusted for stratification factors: tumor (T)-stage, nodal status, hormone receptor status, planned paclitaxel dosing schedule, and geographic region.||1.3660|1.0327|0.0430
72539966|NCT01901146|144609660|OTHER|Analyses of secondary endpoints were prespecified to be considered descriptive only.|Risk Difference (RD)|6.0||||0.1086|TWO_SIDED|90.0|-0.2|12.2|||Generalized linear model|Generalized linear model adjusted for the randomization stratification factors.||The analysis of risk difference (ABP 980 - Trastuzumab) estimated using a generalized linear model adjusted for the randomization stratification factors T-stage, node status, hormone receptor status, planned paclitaxel dosing schedule, and geographic region.||12.2|-0.2|0.1086
72539967|NCT01901146|144609660|OTHER|Analyses of secondary endpoints were prespecified to be considered descriptive only.|Risk Ratio (RR)|1.1463||||0.0807|TWO_SIDED|90.0|1.008|1.3035|||Generalized linear model|Generalized linear model adjusted for the randomization stratification factors.||The analysis of risk ratio (ABP 980 / Trastuzumab) estimated using a generalized linear model adjusted for the randomization stratification factors T-stage, node status, hormone receptor status, planned paclitaxel dosing schedule, and geographic region.||1.3035|1.0080|0.0807
72539968|NCT01901146|144609661|OTHER|Analyses of secondary endpoints were prespecified to be considered descriptive only.|Risk Difference (RD)|8.0||||0.0253|TWO_SIDED|90.0|2.1|13.9|||Generalized linear model|Generalized linear model adjusted for the randomization stratification factors.||The analysis of risk difference (ABP 980 - Trastuzumab) estimated using a generalized linear model adjusted for the randomization stratification factors T-stage, node status, hormone receptor status, planned paclitaxel dosing schedule, and geographic region.||13.9|2.1|0.0253
72539969|NCT01901146|144609661|OTHER|Analyses of secondary endpoints were prespecified to be considered descriptive only.|Risk Ratio (RR)|1.2746||||0.0245|TWO_SIDED|90.0|1.0673|1.5222|||Generalized linear model|Generalized linear model adjusted for the randomization stratification factors.||The analysis of risk ratio (ABP 980 / Trastuzumab) estimated using a generalized linear model adjusted for the randomization stratification factors T-stage, node status, hormone receptor status, planned paclitaxel dosing schedule, and geographic region.||1.5222|1.0673|0.0245
72539970|NCT00606801|144609672|SUPERIORITY_OR_OTHER_LEGACY|||||||0.006|||||||Mixed Models Analysis|||A mixed-effect, repeated-measures model using main effect terms of treatment (placebo or galantine) and time (day of measurement). Interaction of main effects were also analyzed, with a random effect for participant. Given the hypothesis generating nature of the study, values of p\<0.05 were considered statistically significant based on two-tailed tests. Significant interactions were followed by Bonferroni post hoc pairwise comparisons.||||0.006
72575348|NCT01338870|144676548|SUPERIORITY_OR_OTHER||LS mean difference|-0.37|STANDARD_ERROR_OF_MEAN|0.402||0.3599|TWO_SIDED|95.0|-1.16|0.42|||Mixed Models Analysis|||Week 8: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.42|-1.16|0.3599
72575349|NCT01338870|144676548|SUPERIORITY_OR_OTHER||LS mean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.407||0.46|TWO_SIDED|95.0|-1.1|0.5|||Mixed Models Analysis|||Week 8: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.50|-1.10|0.4600
72539971|NCT00606801|144609673|SUPERIORITY_OR_OTHER_LEGACY|||||||0.04|||||||Mixed Models Analysis|||A mixed-effect, repeated-measures model using main effect terms of treatment (placebo or galantine) and time (day of measurement). Interaction of main effects were also analyzed, with a random effect for participant. Given the hypothesis generating nature of the study, values of p\<0.05 were considered statistically significant based on two-tailed tests. Significant interactions were followed by Bonferroni post hoc pairwise comparisons.||||0.04
72539972|NCT00606801|144609674|SUPERIORITY_OR_OTHER_LEGACY|||||||0.02|||||||Mixed Models Analysis|||A mixed-effect, repeated-measures model using main effect terms of treatment (placebo or galantine) and time (day of measurement). Interaction of main effects were also analyzed, with a random effect for participant. Given the hypothesis generating nature of the study, values of p\<0.05 were considered statistically significant based on two-tailed tests. Significant interactions were followed by Bonferroni post hoc pairwise comparisons.||||0.02
72539973|NCT00606801|144609675|SUPERIORITY_OR_OTHER_LEGACY|||||||0.03|||||||Mixed Models Analysis|||A mixed-effect, repeated-measures model using main effect terms of treatment (placebo or galantine) and time (day of measurement). Interaction of main effects were also analyzed, with a random effect for participant. Given the hypothesis generating nature of the study, values of p\<0.05 were considered statistically significant based on two-tailed tests. Significant interactions were followed by Bonferroni post hoc pairwise comparisons.||||0.03
72539974|NCT00606801|144609676|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5|||||||Mixed Models Analysis|||A mixed-effect, repeated-measures model using main effect terms of treatment (placebo or galantine) and time (day of measurement). Interaction of main effects were also analyzed, with a random effect for participant. Given the hypothesis generating nature of the study, values of p\<0.05 were considered statistically significant based on two-tailed tests. Significant interactions were followed by Bonferroni post hoc pairwise comparisons.||||0.5
72539975|NCT00606801|144609677|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7|||||||Mixed Models Analysis|||A mixed-effect, repeated-measures model using main effect terms of treatment (placebo or galantine) and time (day of measurement). Interaction of main effects were also analyzed, with a random effect for participant. Given the hypothesis generating nature of the study, values of p\<0.05 were considered statistically significant based on two-tailed tests. Significant interactions were followed by Bonferroni post hoc pairwise comparisons.||||0.7
72539976|NCT00606801|144609678|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3|||||||Mixed Models Analysis|||A mixed-effect, repeated-measures model using main effect terms of treatment (placebo or galantine) and time (day of measurement). Interaction of main effects were also analyzed, with a random effect for participant. Given the hypothesis generating nature of the study, values of p\<0.05 were considered statistically significant based on two-tailed tests. Significant interactions were followed by Bonferroni post hoc pairwise comparisons.||||0.3
72539977|NCT00606801|144609679|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3|||||||Mixed Models Analysis|||A mixed-effect, repeated-measures model using main effect terms of treatment (placebo or galantine) and time (day of measurement). Interaction of main effects were also analyzed, with a random effect for participant. Given the hypothesis generating nature of the study, values of p\<0.05 were considered statistically significant based on two-tailed tests. Significant interactions were followed by Bonferroni post hoc pairwise comparisons.||||0.3
72539978|NCT00606801|144609680|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3|||||||Mixed Models Analysis|||A mixed-effect, repeated-measures model using main effect terms of treatment (placebo or galantine) and time (day of measurement). Interaction of main effects were also analyzed, with a random effect for participant. Given the hypothesis generating nature of the study, values of p\<0.05 were considered statistically significant based on two-tailed tests. Significant interactions were followed by Bonferroni post hoc pairwise comparisons.||||0.3
72539979|NCT00606801|144609681|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9|||||||Mixed Models Analysis|||A mixed-effect, repeated-measures model using main effect terms of treatment (placebo or galantine) and time (day of measurement). Interaction of main effects were also analyzed, with a random effect for participant. Given the hypothesis generating nature of the study, values of p\<0.05 were considered statistically significant based on two-tailed tests. Significant interactions were followed by Bonferroni post hoc pairwise comparisons.||||0.9
72539980|NCT00606801|144609682|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8|||||||Mixed Models Analysis|||A mixed-effect, repeated-measures model using main effect terms of treatment (placebo or galantine) and time (day of measurement). Interaction of main effects were also analyzed, with a random effect for participant. Given the hypothesis generating nature of the study, values of p\<0.05 were considered statistically significant based on two-tailed tests. Significant interactions were followed by Bonferroni post hoc pairwise comparisons.||||0.8
72539981|NCT00606801|144609683|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5|||||||Mixed Models Analysis|||A mixed-effect, repeated-measures model using main effect terms of treatment (placebo or galantine) and time (day of measurement). Interaction of main effects were also analyzed, with a random effect for participant. Given the hypothesis generating nature of the study, values of p\<0.05 were considered statistically significant based on two-tailed tests. Significant interactions were followed by Bonferroni post hoc pairwise comparisons.||||0.5
72539982|NCT00606801|144609684|SUPERIORITY_OR_OTHER_LEGACY|||||||0.01|||||||Mixed Models Analysis|||A mixed-effect, repeated-measures model using main effect terms of treatment (placebo or galantine) and time (day of measurement). Interaction of main effects were also analyzed, with a random effect for participant. Given the hypothesis generating nature of the study, values of p\<0.05 were considered statistically significant based on two-tailed tests. Significant interactions were followed by Bonferroni post hoc pairwise comparisons.||||0.01
72539983|NCT00606801|144609685|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6|||||||Mixed Models Analysis|||A mixed-effect, repeated-measures model using main effect terms of treatment (placebo or galantine) and time (day of measurement). Interaction of main effects were also analyzed, with a random effect for participant. Given the hypothesis generating nature of the study, values of p\<0.05 were considered statistically significant based on two-tailed tests. Significant interactions were followed by Bonferroni post hoc pairwise comparisons.||||0.60
72539984|NCT00606801|144609686|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5|||||||Mixed Models Analysis|||A mixed-effect, repeated-measures model using main effect terms of treatment (placebo or galantine) and time (day of measurement). Interaction of main effects were also analyzed, with a random effect for participant. Given the hypothesis generating nature of the study, values of p\<0.05 were considered statistically significant based on two-tailed tests. Significant interactions were followed by Bonferroni post hoc pairwise comparisons.||||0.50
72539985|NCT01160198|144609710|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Paired t-test|||Baseline Hb vs. Hb at Week 8 for Ferrous bisglycinate chelate 60 mg 1 once-daily||||<0.0001
72539986|NCT01160198|144609710|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Paired t-test|||Baseline Hb vs. Hb at Week 8 for Ferrous bisglycinate chelate 60 mg 1 twice-daily||||<0.0001
72539987|NCT01160198|144609712|SUPERIORITY_OR_OTHER|||||||0.788|||||||Chi-squared|||Ferrous bisglycinate chelate 60 mg 1 once-daily vs. Ferrous bisglycinate chelate 60 mg 1 twice-daily||||0.788
72539988|NCT01160198|144609712|SUPERIORITY_OR_OTHER|||||||0.911|||||||Chi-squared|||Ferrous bisglycinate chelate 60 mg 1 once-daily vs. Ferrous ascorbate 100mg 1 once-daily||||0.911
72539989|NCT01160198|144609712|SUPERIORITY_OR_OTHER|||||||0.7|||||||Chi-squared|||Ferrous bisglycinate chelate 60 mg 1 twice-daily vs. Ferrous ascorbate 100mg 1 once-daily||||0.700
72539990|NCT01160198|144609713|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||1|TWO_SIDED|95.0|-0.29|0.17|||Repeated Measure ANOVA model|||Ferrous bisglycinate chelate 60 mg 1 once-daily vs. Ferrous bisglycinate chelate 60 mg 1 twice-daily at Week 2||0.17|-0.29|1
72539991|NCT01160198|144609713|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||1||95.0|-0.57|0.31|||Repeated Measure ANOVA model|||Ferrous bisglycinate chelate 60 mg 1 once-daily vs. Ferrous bisglycinate chelate 60 mg 1 twice-daily at Week 4||0.31|-0.57|1
72539992|NCT01160198|144609713|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||1|TWO_SIDED|95.0|-0.75|0.46|||Repeated Measure ANOVA model|||Ferrous bisglycinate chelate 60 mg 1 once-daily vs. Ferrous bisglycinate chelate 60 mg 1 twice-daily at Week 6||0.46|-0.75|1
72539993|NCT01160198|144609713|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3||||1|TWO_SIDED|95.0|-1.05|0.53|||Repeated Measure ANOVA model|||Ferrous bisglycinate chelate 60 mg 1 once-daily vs. Ferrous bisglycinate chelate 60 mg 1 twice-daily at Week 8||0.53|-1.05|1
72539994|NCT01160198|144609713|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.49|TWO_SIDED|95.0|-0.35|0.09|||Repeated Measure ANOVA model|||Ferrous bisglycinate chelate 60 mg 1 once-daily vs. Ferrous ascorbate 100mg 1 once-daily at Week 2||0.09|-0.35|0.490
72539995|NCT01160198|144609713|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2||||1|TWO_SIDED|95.0|-0.58|0.29|||Repeated Measure ANOVA model|||Ferrous bisglycinate chelate 60 mg 1 once-daily vs. Ferrous ascorbate 100 mg 1 once-daily at Week 4||0.29|-0.58|1
72539996|NCT01160198|144609713|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||1|TWO_SIDED|95.0|-0.68|0.51|||Repeated Measure ANOVA model|||Ferrous bisglycinate chelate 60 mg 1 once-daily vs. Ferrous ascorbate 100 mg 1 once-daily at Week 6||0.51|-0.68|1
72539997|NCT01160198|144609713|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||1|TWO_SIDED|95.0|-0.84|0.72|||Repeated Measure ANOVA model|||Ferrous bisglycinate chelate 60 mg 1 once-daily vs. Ferrous ascorbate 100 mg 1 once-daily at Week 8||0.72|-0.84|1
72539998|NCT01160198|144609713|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||1|TWO_SIDED|95.0|-0.29|0.15|||Repeated Measure ANOVA model|||Ferrous bisglycinate chelate 60 mg 1 twice-daily vs. Ferrous ascorbate 100mg 1 once-daily at Week 2||0.15|-0.29|1
72539999|NCT01160198|144609713|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||1|TWO_SIDED|95.0|-0.45|0.42|||Repeated Measure ANOVA model|||Ferrous bisglycinate chelate 60 mg 1 twice-daily vs. Ferrous ascorbate 100 mg 1 once-daily at Week 4||0.42|-0.45|1
72540000|NCT01160198|144609713|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||1|TWO_SIDED|95.0|-0.53|0.65|||Repeated Measure ANOVA model|||Ferrous bisglycinate chelate 60 mg 1 twice-daily vs. Ferrous ascorbate 100 mg 1 once-daily at Week 6||0.65|-0.53|1
72540001|NCT01160198|144609713|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2||||1|TWO_SIDED|95.0|-0.58|0.98|||Repeated Measure ANOVA model|||Ferrous bisglycinate chelate 60 mg 1 twice-daily vs. Ferrous ascorbate 100 mg 1 once-daily at Week 8||0.98|-0.58|1
72540002|NCT02413879|144609718|SUPERIORITY||||||<|0.001|||||||McNemar|||||||<0.001
72540003|NCT02413879|144609720|SUPERIORITY||||||<|0.001|||||||McNemar|||||||<0.001
72540004|NCT02016755|144609725|SUPERIORITY|||||||0.331|||||||t-test, 2 sided|||Overall (LOCF)||||0.331
72540005|NCT02016755|144609725|SUPERIORITY|||||||0.362|||||||t-test, 2 sided|||Activity (LOCF)||||0.362
72540006|NCT02016755|144609725|SUPERIORITY|||||||0.159|||||||t-test, 2 sided|||Emotional (LOCF)||||0.159
72540007|NCT02016755|144609725|SUPERIORITY|||||||0.468|||||||t-test, 2 sided|||Pain (LOCF)||||0.468
72540008|NCT02016755|144609725|SUPERIORITY|||||||0.197|||||||t-test, 2 sided|||Social (LOCF)||||0.197
72540009|NCT02016755|144609725|SUPERIORITY|||||||0.448|||||||t-test, 2 sided|||Symptom (LOCF)||||0.448
72540010|NCT02016755|144609726|SUPERIORITY|||||||0.939|||||||t-test, 2 sided|||Change from Baseline at Month 3||||0.939
72540011|NCT02016755|144609726|SUPERIORITY|||||||0.508|||||||t-test, 2 sided|||Change from Baseline at Month 6||||0.508
72540012|NCT02016755|144609726|SUPERIORITY|||||||0.474|||||||t-test, 2 sided|||Change from Baseline at Month 9||||0.474
72540013|NCT02016755|144609726|SUPERIORITY|||||||0.361|||||||t-test, 2 sided|||Change from Baseline at Month 12||||0.361
72540014|NCT02016755|144609726|SUPERIORITY|||||||0.258|||||||t-test, 2 sided|||Change from Baseline at Month 15||||0.258
72540015|NCT02016755|144609726|SUPERIORITY|||||||0.059|||||||t-test, 2 sided|||Change from baseline at Month 18||||0.059
72540016|NCT02016755|144609726|SUPERIORITY|||||||0.023|||||||t-test, 2 sided|||Change from Baseline at LOCF||||0.023
72540017|NCT02016755|144609727|SUPERIORITY|||||||0.655|||||||t-test, 2 sided|||Change from Baseline at Month 3 (Dorsalis pedis)||||0.655
72540018|NCT02016755|144609727|SUPERIORITY|||||||0.31|||||||t-test, 2 sided|||Change from Baseline at Month 6 (Dorsalis pedis)||||0.310
72540019|NCT02016755|144609727|SUPERIORITY|||||||0.348|||||||t-test, 2 sided|||Change from Baseline at Month 9 (Dorsalis pedis)||||0.348
72540020|NCT02016755|144609727|SUPERIORITY|||||||0.501|||||||t-test, 2 sided|||Change from Baseline at Month 12 (Dorsalis pedis)||||0.501
72540021|NCT02016755|144609727|SUPERIORITY|||||||0.536|||||||t-test, 2 sided|||Change from Baseline at Month 15 (Dorsalis pedis)||||0.536
72540022|NCT02016755|144609727|SUPERIORITY|||||||0.14|||||||t-test, 2 sided|||Change from Baseline at Month 18 (Dorsalis pedis)||||0.140
72540023|NCT02016755|144609727|SUPERIORITY|||||||0.018|||||||t-test, 2 sided|||Change from Baseline at LOCF (Dorsalis pedis)||||0.018
72540024|NCT02016755|144609727|SUPERIORITY|||||||0.716|||||||t-test, 2 sided|||Change from baseline at Month 3 (Posterior tibial)||||0.716
72540025|NCT02016755|144609727|SUPERIORITY|||||||0.641|||||||t-test, 2 sided|||Change from baseline at Month 6 (Posterior tibial)||||0.641
72540026|NCT02016755|144609727|SUPERIORITY|||||||0.514|||||||t-test, 2 sided|||Change from baseline at Month 9 (Posterior tibial)||||0.514
72540027|NCT02016755|144609727|SUPERIORITY|||||||0.808|||||||t-test, 2 sided|||Change from baseline at Month 12 (Posterior tibial)||||0.808
72540028|NCT02016755|144609727|SUPERIORITY|||||||0.396|||||||t-test, 2 sided|||Change from baseline at Month 15 (Posterior tibial)||||0.396
72540029|NCT02016755|144609727|SUPERIORITY|||||||0.162|||||||t-test, 2 sided|||Change from baseline at Month 18 (Posterior tibial)||||0.162
72540030|NCT02016755|144609727|SUPERIORITY|||||||0.259|||||||t-test, 2 sided|||Change from baseline at LOCF (Posterior tibial)||||0.259
72540031|NCT02016755|144609728|SUPERIORITY|||||||0.671|||||||t-test, 2 sided|||Change from Baseline at Month 3||||0.671
72540032|NCT02016755|144609728|SUPERIORITY|||||||0.925|||||||t-test, 2 sided|||Change from Baseline at Month 6||||0.925
72540033|NCT02016755|144609728|SUPERIORITY|||||||0.514|||||||t-test, 2 sided|||Change from Baseline at Month 9||||0.514
72540034|NCT02016755|144609728|SUPERIORITY|||||||0.302|||||||t-test, 2 sided|||Change from Baseline at Month 12||||0.302
72540035|NCT02016755|144609728|SUPERIORITY|||||||0.373|||||||t-test, 2 sided|||Change from Baseline at Month 15||||0.373
72540036|NCT02016755|144609728|SUPERIORITY|||||||0.505|||||||t-test, 2 sided|||Change from Baseline at Month 18||||0.505
72540037|NCT02016755|144609728|SUPERIORITY|||||||0.135|||||||t-test, 2 sided|||Change from Baseline at LOCF||||0.135
72540038|NCT02016755|144609728|SUPERIORITY|||||||0.175|||||||t-test, 2 sided|||Change from baseline at month 3 (Left)||||0.175
72540039|NCT02016755|144609728|SUPERIORITY|||||||0.393|||||||t-test, 2 sided|||Change from baseline at month 6 (Left)||||0.393
72540040|NCT02016755|144609728|SUPERIORITY|||||||0.928|||||||t-test, 2 sided|||Change from baseline at month 9 (Left)||||0.928
72540041|NCT02016755|144609728|SUPERIORITY|||||||0.429|||||||t-test, 2 sided|||Change from baseline at month 12 (Left)||||0.429
72540042|NCT02016755|144609728|SUPERIORITY|||||||0.907|||||||t-test, 2 sided|||Change from baseline at month 15 (Left)||||0.907
72540043|NCT02016755|144609728|SUPERIORITY|||||||0.3|||||||t-test, 2 sided|||Change from baseline at month 18 (Left)||||0.300
72540044|NCT02016755|144609728|SUPERIORITY|||||||0.214|||||||t-test, 2 sided|||Change from baseline at LOCF (Left)||||0.214
72540045|NCT02016755|144609729|SUPERIORITY|||||||0.655|||||||t-test, 2 sided|||Change from Baseline at Month 3||||0.655
72540046|NCT02016755|144609729|SUPERIORITY|||||||0.226|||||||t-test, 2 sided|||Change from Baseline at Month 6||||0.226
72540047|NCT02016755|144609729|SUPERIORITY|||||||0.38|||||||t-test, 2 sided|||Change from Baseline at Month 9||||0.380
72540048|NCT02016755|144609729|SUPERIORITY|||||||0.187|||||||t-test, 2 sided|||Change from Baseline at Month 12||||0.187
72540049|NCT02016755|144609729|SUPERIORITY|||||||0.203|||||||t-test, 2 sided|||Change from Baseline at Month 15||||0.203
72540050|NCT02016755|144609729|SUPERIORITY|||||||0.074|||||||t-test, 2 sided|||Change from Baseline at Month 18||||0.074
72540051|NCT02016755|144609729|SUPERIORITY|||||||0.038|||||||t-test, 2 sided|||Change from Baseline at LOCF||||0.038
72540052|NCT02016755|144609730|SUPERIORITY|||||||0.246|||||||t-test, 2 sided|||Change from Baseline at Month 3||||0.246
72540053|NCT02016755|144609730|SUPERIORITY|||||||0.474|||||||t-test, 2 sided|||Change from Baseline at Month 6||||0.474
72540054|NCT02016755|144609730|SUPERIORITY|||||||0.395|||||||t-test, 2 sided|||Change from Baseline at Month 9||||0.395
72540055|NCT02016755|144609730|SUPERIORITY|||||||0.22|||||||t-test, 2 sided|||Change from Baseline at Month 12||||0.220
72540056|NCT02016755|144609730|SUPERIORITY|||||||0.454|||||||t-test, 2 sided|||Change from Baseline at Month 15||||0.454
72540057|NCT02016755|144609730|SUPERIORITY|||||||0.167|||||||t-test, 2 sided|||Change from Baseline at Month 18||||0.167
72540058|NCT02016755|144609730|SUPERIORITY|||||||0.015|||||||t-test, 2 sided|||Change from Baseline at LOCF||||0.015
72540059|NCT02533505|144609744|SUPERIORITY||Mean Difference (Final Values)|10.114||||0.007|TWO_SIDED|95.0|2.943|17.286||All p-values ≤ 0.05 after rounding will be considered statistically significant.|Mixed Models Analysis|||||17.286|2.943|0.007
72540060|NCT02533505|144609745|SUPERIORITY||Mean Difference (Final Values)|0.087||||0.111|TWO_SIDED|95.0|-0.021|0.196|||Mixed Models Analysis|||||0.196|-0.021|0.111
72540061|NCT02533505|144609746|SUPERIORITY||Mean Difference (Final Values)|0.35||||0.609|TWO_SIDED|95.0|-1.018|1.719|||Mixed Models Analysis|||ΔHR||1.719|-1.018|0.609
72540062|NCT02533505|144609747|SUPERIORITY||Mean Difference (Final Values)|0.191|||<|0.001|TWO_SIDED|95.0|0.15|0.233|||Mixed Models Analysis|||ΔFEV1||0.233|0.150|<0.001
72540063|NCT02533505|144609747|SUPERIORITY||Mean Difference (Final Values)|0.312|||<|0.001|TWO_SIDED|95.0|0.236|0.388|||Mixed Models Analysis|||ΔFVC||0.388|0.236|<0.001
72540064|NCT02533505|144609747|SUPERIORITY||Mean Difference (Final Values)|0.28|||<|0.001|TWO_SIDED|95.0|0.218|0.342|||Mixed Models Analysis|||ΔIC||0.342|0.218|<0.001
72540065|NCT02533505|144609748|SUPERIORITY||Mean Difference (Final Values)|23.315||||0.021|TWO_SIDED|95.0|3.723|42.907|||Mixed Models Analysis|||ΔVT/Ti||42.907|3.723|0.021
72540066|NCT02533505|144609749|SUPERIORITY||Mean Difference (Final Values)|-0.204||||0.106|TWO_SIDED|95.0|-0.454|0.045|||Mixed Models Analysis|||||0.045|-0.454|0.106
72540067|NCT02533505|144609750|SUPERIORITY||Mean Difference (Final Values)|10.245||||0.011|TWO_SIDED|95.0|2.469|18.021|||Mixed Models Analysis|||ΔVCO2||18.021|2.469|0.011
72540068|NCT02533505|144609751|SUPERIORITY||Mean Difference (Final Values)|0.242||||0.333|TWO_SIDED|95.0|-0.255|0.738|||Mixed Models Analysis|||ΔSaO2||0.738|-0.255|0.333
72540069|NCT02533505|144609752|SUPERIORITY||Mean Difference (Final Values)|0.237||||0.484|TWO_SIDED|95.0|-0.439|0.913|||Mixed Models Analysis|||ΔRR||0.913|-0.439|0.484
72540070|NCT02533505|144609753|SUPERIORITY||Mean Difference (Final Values)|0.016||||0.113|TWO_SIDED|95.0|-0.004|0.036|||Mixed Models Analysis|||ΔTi/Ttot||0.036|-0.004|0.113
72540071|NCT02533505|144609754|SUPERIORITY||Mean Difference (Final Values)|57.624|||<|0.001|TWO_SIDED|95.0|29.701|85.546|||Mixed Models Analysis|||ΔVt||85.546|29.701|<0.001
72540072|NCT02533505|144609755|SUPERIORITY||Mean Difference (Final Values)|862.157|||<|0.001|TWO_SIDED|95.0|439.817|1284.496|||Mixed Models Analysis|||ΔVe||1284.496|439.817|<0.001
72540073|NCT02533505|144609756|SUPERIORITY||Mean Difference (Final Values)|0.019||||0.007|TWO_SIDED|95.0|0.005|0.033|||Mixed Models Analysis|||ΔFEV1/FVC||0.033|0.005|0.007
72540074|NCT01467570|144609803|NON_INFERIORITY_OR_EQUIVALENCE|The differences between study groups were considered significant when the p value was \<0.05 or when the 95% CI for RD or MD did not include 0 (equivalent to p \< 0.05).||||||0.28|||||||t-test, 1 sided|||||||0.28
72409749|NCT03062891|144327980|SUPERIORITY||Slope|-0.25||||0.8|TWO_SIDED|95.0|-2.16|1.67|||Regression, Linear|||This analysis looked at the interaction between baseline positive mental health and group on the change in insomnia symptoms across the intervention. The results of the interaction are reported here.||1.67|-2.16|.800
72409750|NCT03062891|144327981|SUPERIORITY||Slope|0.59||||0.525|TWO_SIDED|95.0|-1.25|2.44|||Regression, Linear|||This analysis looked at the interaction between baseline perceived stress and group on the change in insomnia symptoms across the intervention. The results of the interaction are reported here.||2.44|-1.25|.525
72540075|NCT01222715|144609828|SUPERIORITY_OR_OTHER|||||||0.0124|TWO_SIDED|95.0|||||Log Rank|||The event free survival distributions of patients in Regimen A and Regimen B were compared using the log-rank test.||||0.0124
72540076|NCT03555890|144609849|EQUIVALENCE|If the 90 percent (%) confidence interval of the geometric mean ratio (Levocetirizine ODT/ Levocetirizine IRT) was within the acceptable range of 0.80 to 1.25 then Levocetirizine ODT was to be considered bioequivalent to the Levocetirizine IRT.|Ratio of geometric mean|0.975|||||TWO_SIDED|90.0|0.948|1.003||||||||1.003|0.948|
72540077|NCT03555890|144609850|EQUIVALENCE|If the 90 percent (%) confidence interval of the geometric mean ratio (Levocetirizine ODT/ Levocetirizine IRT) was within the acceptable range of 0.80 to 1.25 then Levocetirizine ODT was to be considered bioequivalent to the Levocetirizine IRT.|Ratio of geometric mean|0.978|||||TWO_SIDED|90.0|0.958|0.998||||||||0.998|0.958|
72540078|NCT03555890|144609851|EQUIVALENCE|If the 90 percent (%) confidence interval of the geometric mean ratio (Levocetirizine ODT/ Levocetirizine IRT) was within the acceptable range of 0.80 to 1.25 then Levocetirizine ODT was to be considered bioequivalent to the Levocetirizine IRT.|Ratio of geometric mean|0.934|||||TWO_SIDED|90.0|0.875|0.998||||||||0.998|0.875|
72540079|NCT03555890|144609852|EQUIVALENCE|If the 90 percent (%) confidence interval of the geometric mean ratio (Levocetirizine ODT/ Levocetirizine IRT) was within the acceptable range of 0.80 to 1.25 then Levocetirizine ODT was to be considered bioequivalent to the Levocetirizine IRT.|Ratio of geometric mean|0.857|||||TWO_SIDED|90.0|0.815|0.902||||||||0.902|0.815|
72540080|NCT03372369|144609913|SUPERIORITY||||||<|0.0001||||||The Bonferroni correction is used to account for multiple comparisons. In this analysis, p\<0.01 is the threshold for statistical significance.|t-test, 1 sided|||The null hypothesis is that the change in the contraceptive knowledge score for the CDC poster between baseline and followup is 0.||||<0.0001
72540081|NCT03372369|144609913|SUPERIORITY||||||<|0.0001||||||The Bonferroni correction is used to account for multiple comparisons. In this analysis, p\<0.01 is the threshold for statistical significance.|t-test, 1 sided|||The null hypothesis is that the change in the contraceptive knowledge score for the patient-centered poster between baseline and followup is 0.||||<0.0001
72575350|NCT01338870|144676548|SUPERIORITY_OR_OTHER||LS mean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.504||0.4253|TWO_SIDED|95.0|-1.39|0.59|||Mixed Models Analysis|||Week 12: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.59|-1.39|0.4253
72540082|NCT03372369|144609913|SUPERIORITY||||||<|0.0001||||||The Bonferroni correction is used to account for multiple comparisons. In this analysis, p\<0.01 is the threshold for statistical significance.|t-test, 1 sided|||The null hypothesis is that the patient-centered poster does not produce a larger increase in the contraceptive knowledge score between baseline and followup than the CDC poster.||||<0.0001
72540083|NCT03372369|144609914|SUPERIORITY||||||<|0.001||||||The Bonferroni correction is used to account for multiple comparisons. In this analysis, p\<0.01 is the threshold for statistical significance.|t-test, 1 sided|||The null hypothesis is that the change in the effective contraception preference score for the CDC poster between baseline and followup is 0.||||<0.001
72540084|NCT03372369|144609914|SUPERIORITY||||||<|0.01||||||The Bonferroni correction is used to account for multiple comparisons. In this analysis, p\<0.01 is the threshold for statistical significance.|t-test, 1 sided|||The null hypothesis is that the change in the effective contraception preference score for the patient-centered poster between baseline and followup is 0.||||<0.01
72540085|NCT03372369|144609914|SUPERIORITY||||||>|0.01||||||The Bonferroni correction is used to account for multiple comparisons. In this analysis, p\<0.01 is the threshold for statistical significance.|t-test, 1 sided|||The null hypothesis is that the patient-centered poster does not produce a larger increase in the effective contraception preference score between baseline and followup than the CDC poster.||||>0.01
72540086|NCT03372369|144609915|SUPERIORITY||||||>|0.01||||||The Bonferroni correction is used to account for multiple comparisons. In this analysis, p\<0.01 is the threshold for statistical significance.|t-test, 1 sided|||The null hypothesis is that the change in the perceived pregnancy risk score for the CDC poster between baseline and followup is 0.||||>0.01
72540087|NCT03372369|144609915|SUPERIORITY||||||>|0.01||||||The Bonferroni correction is used to account for multiple comparisons. In this analysis, p\<0.01 is the threshold for statistical significance.|t-test, 1 sided|||The null hypothesis is that the change in the perceived pregnancy risk score for the patient-centered poster between baseline and followup is 0.||||>0.01
72540088|NCT03372369|144609915|SUPERIORITY||||||>|0.01||||||The Bonferroni correction is used to account for multiple comparisons. In this analysis, p\<0.01 is the threshold for statistical significance.|t-test, 1 sided|||The null hypothesis is that the patient-centered poster does not produce a larger increase in the perceived pregnancy risk score between baseline and followup than the CDC poster.||||>0.01
72409751|NCT03062891|144327982|SUPERIORITY||Slope|1.3||||0.14|TWO_SIDED|95.0|-0.43|3.03|||Regression, Linear|||This analysis looked at the interaction between baseline threatening life events and group on the change in insomnia symptoms across the intervention. The results of the interaction are reported here.||3.03|-0.43|.140
72409752|NCT03062891|144327983|SUPERIORITY||Slope|-2.58||||0.03|TWO_SIDED|95.0|-4.9|-0.25|||Generalized estimating equation|||This analysis looked at the effect of group on changes in anxiety symptoms across the intervention period.||-0.25|-4.90|.030
72575351|NCT01338870|144676548|SUPERIORITY_OR_OTHER||LS mean difference|0.39|STANDARD_ERROR_OF_MEAN|0.497||0.4349|TWO_SIDED|95.0|-0.59|1.37|||Mixed Models Analysis|||Week 12: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||1.37|-0.59|0.4349
72540089|NCT03372369|144609916|SUPERIORITY||||||>|0.01||||||The Bonferroni correction is used to account for multiple comparisons. In this analysis, p\<0.01 is the threshold for statistical significance.|t-test, 1 sided|||The null hypothesis is that the change in the accuracy of perceived pregnancy risk score for the CDC poster between baseline and followup is 0.||||>0.01
72540090|NCT03372369|144609916|SUPERIORITY||||||>|0.01||||||The Bonferroni correction is used to account for multiple comparisons. In this analysis, p\<0.01 is the threshold for statistical significance.|t-test, 1 sided|||The null hypothesis is that the change in the accuracy of perceived pregnancy risk score for the patient-centered poster between baseline and followup is 0.||||>0.01
72540091|NCT03372369|144609916|SUPERIORITY||||||>|0.01||||||The Bonferroni correction is used to account for multiple comparisons. In this analysis, p\<0.01 is the threshold for statistical significance.|t-test, 1 sided|||The null hypothesis is that the patient-centered poster does not produce a larger increase in the accuracy of perceived pregnancy risk score between baseline and followup than the CDC poster.||||>0.01
72540092|NCT02239601|144609917|OTHER||Odds Ratio (OR)|0.41||||0.053|TWO_SIDED|95.0|0.17|1.01|||Mixed Models Analysis|||||1.01|0.17|0.053
72540093|NCT04682639|144609924|OTHER||LS mean difference|-18.54||||0.0103|TWO_SIDED|95.0|-32.6|-4.49|||ANCOVA||Estimates were from ANCOVA model for rank score of percent change from baseline in esophageal PEC.|||-4.49|-32.60|0.0103
72540094|NCT04682639|144609924|OTHER||LS mean difference|-7.53||||0.2861|TWO_SIDED|95.0|-21.48|6.42|||ANCOVA||Estimates were from ANCOVA model for rank score of percent change from baseline in esophageal PEC.|||6.42|-21.48|0.2861
72540095|NCT04682639|144609925|OTHER||LS mean difference|2.38||||0.4894|TWO_SIDED|95.0|-4.43|9.19|||Linear mixed effects model|||||9.19|-4.43|0.4894
72540096|NCT04682639|144609925|OTHER||LS mean difference|4.7||||0.1671|TWO_SIDED|95.0|-2.0|11.41|||Linear mixed effects model|||||11.41|-2.00|0.1671
72575352|NCT01338870|144676548|SUPERIORITY_OR_OTHER||LS mean difference|-0.21|STANDARD_ERROR_OF_MEAN|0.492||0.6697|TWO_SIDED|95.0|-1.18|0.76|||Mixed Models Analysis|||Week 12: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.76|-1.18|0.6697
72575353|NCT01338870|144676548|SUPERIORITY_OR_OTHER||LS mean difference|-0.28|STANDARD_ERROR_OF_MEAN|0.476||0.5501|TWO_SIDED|95.0|-1.22|0.65|||Mixed Models Analysis|||Week 12: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.65|-1.22|0.5501
72540097|NCT04682639|144609926|OTHER||LS mean difference|-54.53||||0.0565|TWO_SIDED|95.0|-110.59|1.54|||ANCOVA|||||1.54|-110.59|0.0565
72540098|NCT04682639|144609926|OTHER||LS mean difference|-13.95||||0.6193|TWO_SIDED|95.0|-69.61|41.71|||ANCOVA|||||41.71|-69.61|0.6193
72540099|NCT04682639|144609927|OTHER||Adjusted difference from placebo|21.9||||0.0007|TWO_SIDED|95.0|9.23|34.57|||Mantel Haenszel|||||34.57|9.23|0.0007
72540100|NCT04682639|144609927|OTHER||Adjusted difference from placebo|13.85||||0.0121|TWO_SIDED|95.0|3.03|24.66|||Mantel Haenszel|||||24.66|3.03|0.0121
72540101|NCT04682639|144609928|OTHER||Adjusted difference from placebo|12.15||||0.0173|TWO_SIDED|95.0|2.15|22.16|||Mantel Haenszel|||||22.16|2.15|0.0173
72540102|NCT04682639|144609928|OTHER||Adjusted difference from placebo|8.37||||0.059|TWO_SIDED|95.0|-0.32|17.07|||Mantel Haenszel|||||17.07|-0.32|0.0590
72540103|NCT00883740|144609931|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-19.15|||<|0.0001|TWO_SIDED|95.0|-26.69|-11.61||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model|||||-11.61|-26.69|<0.0001
72575354|NCT01338870|144676548|SUPERIORITY_OR_OTHER||LS mean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.484||0.4081|TWO_SIDED|95.0|-1.35|0.55|||Mixed Models Analysis|||Week 12: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.55|-1.35|0.4081
72540104|NCT00883740|144609932|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-17.54|||<|0.0001|TWO_SIDED|95.0|-23.29|-11.8||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model|||||-11.80|-23.29|<0.0001
72540105|NCT00883740|144609933|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.81||||0.3841|TWO_SIDED|95.0|-5.92|2.3||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model|||||2.30|-5.92|0.3841
72540106|NCT00883740|144609934|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|25.54|||<|0.0001|TWO_SIDED|95.0|17.48|33.61||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model|||||33.61|17.48|<0.0001
72575355|NCT02348723|144676553|SUPERIORITY_OR_OTHER||Risk Difference (RD) %|-5.3||||0.0009|TWO_SIDED|95.0|-8.4|-2.2|||Chi-squared|||The risk difference between dabigatran etexilate vs. warfarin, its 2-sided 95% CI, and corresponding p-value are presented.||-2.2|-8.4|0.0009
72540107|NCT00883740|144609935|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.42|||<|0.0001|TWO_SIDED|95.0|3.74|7.11||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model|||||7.11|3.74|<0.0001
72540108|NCT00883740|144609936|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.41||||0.0135|TWO_SIDED|95.0|-4.31|-0.51||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model|||||-0.51|-4.31|0.0135
72540109|NCT00883740|144609937|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.53||||0.0008|TWO_SIDED|95.0|-2.41|-0.66||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model|||||-0.66|-2.41|0.0008
72409753|NCT03062891|144327984|SUPERIORITY||Slope|-0.63||||0.456|TWO_SIDED|95.0|-2.24|1.01|||Generalized estimating equation|||This analysis looked at the effect of group on changes in depression symptoms across the intervention period.||1.01|-2.24|.456
72540110|NCT00883740|144609938|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-7.18||||0.0447|TWO_SIDED|95.0|-14.18|-0.17||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model|||||-0.17|-14.18|0.0447
72540111|NCT00883740|144609939|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.34||||0.3613|TWO_SIDED|95.0|-1.07|0.39||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model|||Hour 1||0.39|-1.07|0.3613
72540112|NCT00883740|144609939|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.1||||0.0686|TWO_SIDED|95.0|-2.29|0.09||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model|||Hour 2||0.09|-2.29|0.0686
72540113|NCT00883740|144609939|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.44||||0.0009|TWO_SIDED|95.0|-3.85|-1.03||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model|||Hour 3||-1.03|-3.85|0.0009
72540114|NCT00883740|144609939|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.52||||0.0002|TWO_SIDED|95.0|-5.33|-1.71||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model|||Hour 4||-1.71|-5.33|0.0002
72540115|NCT00883740|144609939|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.01||||0.0065|TWO_SIDED|95.0|-5.16|-0.86||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model|||Hour 5||-0.86|-5.16|0.0065
72540116|NCT00883740|144609939|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.89||||0.0024|TWO_SIDED|95.0|-6.36|-1.41||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model|||Hour 6||-1.41|-6.36|0.0024
72540117|NCT00883740|144609939|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.59||||0.0366|TWO_SIDED|95.0|-5.01|-0.16||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model|||Hour 7||-0.16|-5.01|0.0366
72540118|NCT00883740|144609939|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.85||||0.0593|TWO_SIDED|95.0|-5.82|0.11||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model|||Hour 8||0.11|-5.82|0.0593
72575356|NCT03395405|144676637|SUPERIORITY||Hazard Ratio (HR)|0.74||||0.459|TWO_SIDED|95.0|0.33|1.64||No adjustment for multiple comparisons was made. The a priori threshold for statistical significant is 0.05.|Likelihood Ratio Test|The null hypothesis is that there is no difference in time until clinical resolution between study arms, with a two-sided alternative.|HR estimated from a Cox model|The null hypothesis is that there is no difference in time until clinical resolution between study arms, with a two-sided alternative.||1.64|0.33|0.459
72575357|NCT03395405|144676639|SUPERIORITY|||||||0.735||||||No adjustment for multiple comparisons was made. The a priori threshold for statistical significant is 0.05.|ANCOVA|Titer values were log-transformed||Includes participants in the Norovirus GII subgroup. The null hypothesis is that there is no difference in time until clinical resolution between study arms, with a two-sided alternative.||||0.735
72409754|NCT03062891|144327985|SUPERIORITY||Slope|-2.34||||0.11|TWO_SIDED|95.0|-5.21|0.53|||Generalized estimating equation|||This analysis looked at the effect of group on changes attentional problems across the intervention period.||0.53|-5.21|.110
72540119|NCT00883740|144609940|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.25||||0.1106|TWO_SIDED|95.0|-2.79|0.29||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model|||Quarter 1||0.29|-2.79|0.1106
72540120|NCT00883740|144609940|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.0|||<|0.0001|TWO_SIDED|95.0|-8.49|-3.51||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model|||Quarter 2||-3.51|-8.49|<0.0001
72540121|NCT00883740|144609940|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.83||||0.0004|TWO_SIDED|95.0|-10.53|-3.13||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model|||Quarter 3||-3.13|-10.53|0.0004
72540122|NCT00883740|144609940|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.44||||0.0199|TWO_SIDED|95.0|-10.0|-0.88||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model|||Quarter 4||-0.88|-10.00|0.0199
72575358|NCT03395405|144676643|SUPERIORITY||Hazard Ratio (HR)|0.88||||0.873|TWO_SIDED|95.0|0.19|4.06||No adjustment for multiple comparisons was made. The a priori threshold for statistical significance is 0.05.|Likelihood Ratio Test|||Includes participants in the Norovirus GII subgroup. The null hypothesis is that there is no difference in time until first negative viral load between study arms, with a two-sided alternative.||4.06|0.19|0.873
72409755|NCT03062891|144327986|SUPERIORITY||Slope|-1.69||||0.041|TWO_SIDED|95.0|-3.31|-0.07|||Generalized estimating equations|||This analysis looked at the effect of group on changes in psychotic experiences (paranoia) across the intervention period.||-0.07|-3.31|.041
72540123|NCT00883740|144609941|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.14||||0.0024|TWO_SIDED|95.0|0.78|3.5||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model|||||3.50|0.78|0.0024
72409756|NCT03062891|144327986|SUPERIORITY||Slope|-0.22||||0.531|TWO_SIDED|95.0|-0.92|0.48|||Generalized estimating equation|||This analysis looked at the effect of group on changes in psychotic experiences (hallucinations) across the intervention period.||0.48|-0.92|.531
72540124|NCT00883740|144609942|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-8.13||||0.0591|TWO_SIDED|95.0|-16.59|0.32||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model|||Week 5||0.32|-16.59|0.0591
72540125|NCT00883740|144609942|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-18.81|||<|0.0001|TWO_SIDED|95.0|-27.43|-10.2||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model|||Week 11||-10.20|-27.43|<0.0001
72540126|NCT00883740|144609943|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.47||||0.1101|TWO_SIDED|95.0|-12.2|1.26||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model|||Week 5||1.26|-12.20|0.1101
72540127|NCT00883740|144609943|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-13.39||||0.0002|TWO_SIDED|95.0|-20.36|-6.42||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model|||Week 11||-6.42|-20.36|0.0002
72540128|NCT00883740|144609944|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.91|||<|0.0001|TWO_SIDED|95.0|0.58|1.24||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model|||Week 1||1.24|0.58|<0.0001
72540129|NCT00883740|144609944|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.14|||<|0.0001|TWO_SIDED|95.0|0.76|1.53||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model|||Week 2||1.53|0.76|<0.0001
72540130|NCT00883740|144609944|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.87|||<|0.0001|TWO_SIDED|95.0|0.46|1.28||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model|||Week 3||1.28|0.46|<0.0001
72540131|NCT00883740|144609944|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.89|||<|0.0001|TWO_SIDED|95.0|0.51|1.26||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model|||Week 4||1.26|0.51|<0.0001
72540132|NCT00883740|144609945|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-7.66||||0.0001|TWO_SIDED|95.0|-11.44|-3.89||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model|||Week 1||-3.89|-11.44|0.0001
72540133|NCT00883740|144609945|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-7.67||||0.0077|TWO_SIDED|95.0|-13.27|-2.07||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model|||Week 2||-2.07|-13.27|0.0077
72540134|NCT00883740|144609945|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.68||||0.2196|TWO_SIDED|95.0|-14.81|3.44||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model|||Week 3||3.44|-14.81|0.2196
72540135|NCT00883740|144609945|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.18||||0.0081|TWO_SIDED|95.0|-10.73|-1.64||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model|||Week 4||-1.64|-10.73|0.0081
72540136|NCT00883740|144609946|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.7|||<|0.0001|TWO_SIDED|95.0|-1.02|-0.37||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model|||Week 1||-0.37|-1.02|<0.0001
72540137|NCT00883740|144609946|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.71||||0.0001|TWO_SIDED|95.0|-1.06|-0.36||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model|||Week 2||-0.36|-1.06|0.0001
72540138|NCT00883740|144609946|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.59||||0.0014|TWO_SIDED|95.0|-0.95|-0.24||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model|||Week 3||-0.24|-0.95|0.0014
72540139|NCT00883740|144609946|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.52||||0.0084|TWO_SIDED|95.0|-0.9|-0.14||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model|||Week 4||-0.14|-0.90|0.0084
72409757|NCT03062891|144327986|SUPERIORITY||Slope|-0.37||||0.13|TWO_SIDED|95.0|-0.84|0.11|||Generalized estimating equation|||This analysis looked at the effect of group on changes in psychotic experiences (cognitive disorganization) across the intervention period.||0.11|-0.84|.130
72409758|NCT03062891|144327987|SUPERIORITY||Slope|0.07||||0.916|TWO_SIDED|95.0|-1.17|1.3|||Generalized estimating equation|||This analysis looked at the effect of group on changes in positive mental health across the intervention period.||1.30|-1.17|.916
72540140|NCT00883740|144609947|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-18.27|||<|0.0001|TWO_SIDED|95.0|-27.02|-9.52||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model|||Week 1||-9.52|-27.02|<0.0001
72575359|NCT00000378|144676644|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|||||actual calculation|Regression, Logistic|||logistic regression and mixed effects model||||<0.05
72627465|NCT03366454|144783820|OTHER||AUC|0.6892|STANDARD_ERROR_OF_MEAN|0.05213||0.0029|TWO_SIDED|95.0|0.587|0.7914|||ROC Curve Analysis|||ROC curve analysis was performed to evaluate outcome. The Area Under the Curve (AUC) was calculated along with a 95% confidence interval and statistical significance (p-value).||0.7914|0.5870|0.0029
72627466|NCT03366454|144783821|OTHER||AUC|0.644|STANDARD_ERROR_OF_MEAN|0.05635||0.0233|TWO_SIDED|95.0|0.5335|0.7544|||ROC Curve Analysis||The optimal cutoff value for NLR was determined as 1.335 using the Youden Index.|ROC curve analysis was performed to evaluate outcome. The Area Under the Curve (AUC) was calculated along with a 95% confidence interval and statistical significance (p-value).||0.7544|0.5335|0.0233
72540141|NCT00883740|144609947|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-16.06||||0.0002|TWO_SIDED|95.0|-24.24|-7.87||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model|||Week 2||-7.87|-24.24|0.0002
72409759|NCT03062891|144327988|SUPERIORITY||Slope|-2.03||||0.027|TWO_SIDED|95.0|-3.83|-0.23|||Generalized estimating equation|||This analysis looked at the effect of group on changes in perceived stress across the intervention period.||-0.23|-3.83|.027
72627467|NCT03366454|144783822|OTHER||AUC|0.6884|STANDARD_ERROR_OF_MEAN|0.04709||0.0018|TWO_SIDED|95.0|0.5962|0.7807|||ROC Curve Analysis||The optimal cut-off value for CRP was determined as 5.70 using the Youden Index.|ROC curve analysis was performed to evaluate outcome. The Area Under the Curve (AUC) was calculated along with a 95% confidence interval and statistical significance (p-value)||0.7807|0.5962|0.0018
72409760|NCT03062891|144327990|SUPERIORITY||Odds Ratio (OR)|1.36||||0.296|TWO_SIDED|95.0|0.77|2.4|||Regression, Logistic|||Assocation between baseline anxiety symptoms and exploding head syndrome||2.40|0.77|.296
72409761|NCT03062891|144327990|SUPERIORITY||Odds Ratio (OR)|0.69||||0.065|TWO_SIDED|95.0|0.47|1.02|||Regression, Logistic|||Assocation between baseline insomnia symptoms and exploding head syndrome||1.02|0.47|.065
72540142|NCT00883740|144609947|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-13.23||||0.0085|TWO_SIDED|95.0|-23.01|-3.46||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model|||Week 3||-3.46|-23.01|0.0085
72540143|NCT00883740|144609947|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-10.25||||0.0102|TWO_SIDED|95.0|-18.01|-2.48||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model|||Week 4||-2.48|-18.01|0.0102
72540144|NCT00883740|144609948|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|24.82|||<|0.0001|TWO_SIDED|95.0|13.25|36.4||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model|||Week 1||36.40|13.25|<0.0001
72627468|NCT03366454|144783823|OTHER||AUC|0.7063|STANDARD_ERROR_OF_MEAN|0.04857||0.0007|TWO_SIDED|95.0|0.6111|0.8015|||ROC Curve Analysis||The optimal cutoff value for PCT was determined as 0.141 using the Youden Index.|ROC curve analysis was performed to evaluate outcome. The Area Under the Curve (AUC) was calculated along with a 95% confidence interval and statistical significance (p-value).||0.8015|0.6111|0.0007
72627469|NCT01819272|144783829|SUPERIORITY_OR_OTHER||Hodges-Lehmann Estimation|-9.0||||0.067|TWO_SIDED|95.0|-21.0|1.0||p-value for pair-wise comparison without adjustment|Kruskal-Wallis|||||1.0|-21.0|0.0670
72627470|NCT01819272|144783829|SUPERIORITY_OR_OTHER||Hodges-Lehmann Estimation|-14.0||||0.0057|TWO_SIDED|95.0|-22.0|-4.0||p-value for pair-wise comparison without adjustment|Kruskal-Wallis|||||-4.0|-22.0|0.0057
72627471|NCT01819272|144783829|SUPERIORITY_OR_OTHER||Hodges-Lehmann Estimation|-12.0||||0.1095|TWO_SIDED|95.0|-25.0|3.0||p-value for pair-wise comparison without adjustment|Kruskal-Wallis|||||3.0|-25.0|0.1095
72627472|NCT01819272|144783829|SUPERIORITY_OR_OTHER||Hodges-Lehmann Estimation|-12.0||||0.0097|TWO_SIDED|95.0|-23.0|-3.0||p-value for pair-wise comparison without adjustment|Kruskal-Wallis|||||-3.0|-23.0|0.0097
72627473|NCT01819272|144783829|SUPERIORITY_OR_OTHER||Hodges-Lehmann Estimation|-28.0|||<|0.0001|TWO_SIDED|95.0|-42.0|-17.0||p-value for pair-wise comparison without adjustment|Kruskal-Wallis|||||-17.0|-42.0|<0.0001
72627474|NCT01819272|144783830|SUPERIORITY_OR_OTHER||Hodges-Lehmann Estimation|-106.0||||0.0226|TWO_SIDED|95.0|-208.0|-16.0||p-value for pair-wise comparison without adjustment|Kruskal-Wallis|||||-16.00|-208.0|0.0226
72627475|NCT01819272|144783830|SUPERIORITY_OR_OTHER||Hodges-Lehmann Estimation|-106.0||||0.0068|TWO_SIDED|95.0|-180.0|-32.0||p-value for pair-wise comparison without adjustment|Kruskal-Wallis|||||-32.00|-180.0|0.0068
72627476|NCT01819272|144783830|SUPERIORITY_OR_OTHER||Hodges-Lehmann Estimation|-152.0||||0.0071|TWO_SIDED|95.0|-252.0|-42.0||p-value for pair-wise comparison without adjustment|Kruskal-Wallis|||||-42.00|-252.0|0.0071
72627477|NCT01819272|144783830|SUPERIORITY_OR_OTHER||Hodges-Lehmann Estimation|-101.0||||0.0405|TWO_SIDED|95.0|-208.0|-4.0||p-value for pair-wise comparison without adjustment|Kruskal-Wallis|||||-4.00|-208.0|0.0405
72409762|NCT03062891|144327990|SUPERIORITY||Odds Ratio (OR)|0.67||||0.145|TWO_SIDED|95.0|0.39|1.15|||Regression, Logistic|||Assocation between baseline depression symptoms and exploding head syndrome||1.15|0.39|.145
72627478|NCT01819272|144783830|SUPERIORITY_OR_OTHER||Hodges-Lehmann Estimation|-224.0|||<|0.0001|TWO_SIDED|95.0|-334.0|-118.0||p-value for pair-wise comparison without adjustment|Kruskal-Wallis|||||-118.0|-334.0|<.0001
72627479|NCT01819272|144783831|SUPERIORITY_OR_OTHER||LS Mean|-0.48||||0.01|TWO_SIDED|95.0|-0.85|-0.12|||ANCOVA|Factor for treatment and baseline HbA1c as a covariate||||-0.12|-0.85|0.0100
72627480|NCT01819272|144783831|SUPERIORITY_OR_OTHER||LS Mean|-0.45||||0.0153|TWO_SIDED|95.0|-0.81|-0.09|||ANCOVA|Factor for treatment and baseline HbA1c as a covariate||||-0.09|-0.81|0.0153
72627481|NCT01819272|144783831|SUPERIORITY_OR_OTHER||LS Mean|-0.35||||0.0611|TWO_SIDED|95.0|-0.71|0.02|||ANCOVA|Factor for treatment and baseline HbA1c as a covariate||||0.02|-0.71|0.0611
72627482|NCT01819272|144783831|SUPERIORITY_OR_OTHER||LS Mean|-0.45||||0.0188|TWO_SIDED|95.0|-0.83|-0.08|||ANCOVA|Factor for treatment and baseline HbA1c as acovariate||||-0.08|-0.83|0.0188
72627483|NCT01819272|144783831|SUPERIORITY_OR_OTHER||LS Mean|-0.67||||0.0006|TWO_SIDED|95.0|-1.04|-0.29|||ANCOVA|Factor for treatment and baseline HbA1c as a covariate||||-0.29|-1.04|0.0006
72540145|NCT00883740|144609948|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|29.4|||<|0.0001|TWO_SIDED|95.0|18.59|40.21||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model|||Week 2||40.21|18.59|<0.0001
72409763|NCT03062891|144327990|SUPERIORITY||Odds Ratio (OR)|1.26||||0.398|TWO_SIDED|95.0|0.73|2.19|||Regression, Logistic|||Assocation between baseline life stress and exploding head syndrome||2.19|0.73|.398
72540146|NCT00883740|144609948|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|26.79|||<|0.0001|TWO_SIDED|95.0|15.37|38.21||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model|||Week 3||38.21|15.37|<0.0001
72540147|NCT00883740|144609948|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|25.44|||<|0.0001|TWO_SIDED|95.0|15.03|35.86||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model|||Week 4||35.86|15.03|<0.0001
72540148|NCT00190684|144609998|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value is for systolic BP|Wilcoxon signed-rank test|Change = endpoint-baseline||Tested was the null hypothesis that there would be no statistically significant difference between baseline and endpoint.||||<0.001
72540149|NCT00190684|144609998|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value is for diastolic BP|Wilcoxon sign-rank test|Change = endpoint-baseline||Tested was the null hypothesis that there would be no statistically significant difference between baseline and endpoint.||||<0.001
72540150|NCT00190684|144609999|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value is for pulse|Wilcoxon signed-rank test|||Tested was the null hypothesis that there would be no statistically significant difference between baseline and endpoint.||||<0.001
72540151|NCT00190684|144610000|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value is for weight|Wilcoxon signed-rank test|||Tested was the null hypothesis that there would be no statistically significant difference between baseline and endpoint.||||<0.001
72540152|NCT00190684|144610001|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value is for height|Wilcoxon signed-rank test|||Tested was the null hypothesis that there would be no statistically significant difference between baseline and endpoint.||||<0.001
72540153|NCT00190684|144610002|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value is for weight 0 to 25th percentile|paired t-test|||Tested was the null hypothesis that there would be no statistically significant difference between baseline and endpoint.||||<0.001
72540154|NCT00190684|144610002|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value is for weight 25th to 50th percentile|paired t-test|||Tested was the null hypothesis that there would be no statistically significant difference between baseline and endpoint.||||<0.001
72540155|NCT00190684|144610002|SUPERIORITY_OR_OTHER|||||||0.644||95.0||||p-value is for weight 50th to 75th percentile|paired t-test|||Tested was the null hypothesis that there would be no statistically significant difference between baseline and endpoint.||||0.644
72540156|NCT00190684|144610002|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value is for weight 75th to 100th percentile|paired t-test|||Tested was the null hypothesis that there would be no statistically significant difference between baseline and endpoint.||||<0.001
72540157|NCT00190684|144610002|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value is for height 0 to 25th percentile|paired t-test|||Tested was the null hypothesis that there would be no statistically significant difference between baseline and endpoint.||||<0.001
72409764|NCT03062891|144327990|SUPERIORITY||Odds Ratio (OR)|1.72||||0.001|TWO_SIDED|95.0|1.24|2.38|||Regression, Logistic|||Assocation between sleep paralysis and exploding head syndrome||2.38|1.24|.001
72409765|NCT03221257|144327991|SUPERIORITY||Mean Difference (Net)|-0.14||||0.9326|TWO_SIDED||||||Mixed Models Analysis|||||||0.9326
72540158|NCT00190684|144610002|SUPERIORITY_OR_OTHER|||||||0.001||95.0||||p-value is for height 25th to 50th percentile|paired t-test|||Tested was the null hypothesis that there would be no statistically significant difference between baseline and endpoint.||||0.001
72540159|NCT00190684|144610002|SUPERIORITY_OR_OTHER|||||||0.044||95.0||||p-value is for height 50th to 75th percentile|paired t-test|||Tested was the null hypothesis that there would be no statistically significant difference between baseline and endpoint.||||0.044
72409766|NCT03221257|144327992|SUPERIORITY||Mean Difference (Net)|-0.01||||0.9968|TWO_SIDED||||||Mixed Models Analysis|||||||0.9968
72540160|NCT00190684|144610002|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value is for height 75th to 100th percentile|paired t-test|||Tested was the null hypothesis that there would be no statistically significant difference between baseline and endpoint.||||<0.001
72540161|NCT00190684|144610002|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value is for BMI 0 to 25th percentile|paired t-test|||Tested was the null hypothesis that there would be no statistically significant difference between baseline and endpoint.||||<0.001
72540162|NCT00190684|144610002|SUPERIORITY_OR_OTHER|||||||0.032||95.0||||p-value is for BMI 25th to 50th percentile|paired t-test|||Tested was the null hypothesis that there would be no statistically significant difference between baseline and endpoint.||||0.032
72540163|NCT00190684|144610002|SUPERIORITY_OR_OTHER|||||||0.351||95.0||||p-value is for BMI 50th to 75th percentile|paired t-test|||Tested was the null hypothesis that there would be no statistically significant difference between baseline and endpoint.||||0.351
72540164|NCT00190684|144610002|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value is for BMI 75th to 100th percentile|paired t-test|||Tested was the null hypothesis that there would be no statistically significant difference between baseline and endpoint.||||<0.001
72540165|NCT00190684|144610003|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value is for RR interval|Wilcoxon signed-rank test|||Tested was the null hypothesis that there would be no statistically significant difference between baseline and endpoint.||||<0.001
72540166|NCT00190684|144610003|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value is for QRS Interval|Wilcoxon signed-rank test|||Tested was the null hypothesis that there would be no statistically significant difference between baseline and endpoint.||||<0.001
72540167|NCT00190684|144610003|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value is for QT Bazett Correction|Wilcoxon signed-rank test|||Tested was the null hypothesis that there would be no statistically significant difference between baseline and endpoint.||||<0.001
72409767|NCT03221257|144327993|SUPERIORITY||Mean Difference (Net)|0.46||||0.7489|TWO_SIDED||||||Mixed Models Analysis|||||||0.7489
72409768|NCT03221257|144327994|SUPERIORITY||Mean Difference (Net)|-9.2||||0.8898|TWO_SIDED||||||Mixed Models Analysis|||||||0.8898
72409769|NCT03221257|144327995|SUPERIORITY||Mean Difference (Net)|0.86||||0.3826|TWO_SIDED||||||Mixed Models Analysis|||||||0.3826
72409770|NCT03221257|144327996|SUPERIORITY||Mean Difference (Net)|-0.14||||0.2819|TWO_SIDED||||||Mixed Models Analysis|||||||0.2819
72409771|NCT03221257|144327997|SUPERIORITY||Mean Difference (Net)|-1.35||||0.7534|TWO_SIDED||||||Mixed Models Analysis|||||||0.7534
72540168|NCT00190684|144610003|SUPERIORITY_OR_OTHER|||||||0.31||95.0||||p-value is for QT Data Correction|Wilcoxon signed-rank test|||Tested was the null hypothesis that there would be no statistically significant difference between baseline and endpoint.||||0.310
72540169|NCT00190684|144610003|SUPERIORITY_OR_OTHER|||||||0.632||95.0||||p-value is for QT Fridericia Correction|Wilcoxon signed-rank test|||Tested was the null hypothesis that there would be no statistically significant difference between baseline and endpoint.||||0.632
72540170|NCT00190684|144610004|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value is for HR.|Wilcoxon signed-rank test|||Tested was the null hypothesis that there would be no statistically significant difference between baseline and endpoint.||||<0.001
72540171|NCT00190684|144610006|SUPERIORITY_OR_OTHER||||||p<|0||95.0||||p-value is for Total Score|Wilcoxon signed-rank test|||Tested was the null hypothesis that there would be no statistically significant difference between baseline and endpoint.||||p<0.001
72540172|NCT00190684|144610006|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value is for Inattentive Subscale Score|Wilcoxon signed-rank test|||Tested was the null hypothesis that there would be no statistically significant difference between baseline and endpoint.||||<0.001
72540173|NCT00190684|144610006|SUPERIORITY_OR_OTHER||||||p<|0||95.0||||p-value is for Hyperactive Subscale Score|Wilcoxon signed-rank test|||Tested was the null hypothesis that there would be no statistically significant difference between baseline and endpoint.||||p<0.001
72540174|NCT00190684|144610007|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value is for CGI ADHD Severity within group|Wilcoxon signed-rank test|This test is for a significance of a location shift from zero of the change from baseline within a treatment group.||||||<0.001
72575360|NCT03257865|144676666|SUPERIORITY||Treatment difference|-1.62|||=|0.1011|TWO_SIDED|95.0|-3.56|0.32|||mixed-effect model repeated measure||"Comparison between treatment groups was carried out using MMRM, with study center, treatment group, visit, and treatment group-by-visit interaction as factor and baseline-by-visit interaction as a covariate. An unstructured covariance was used."|||0.32|-3.56|=0.1011
72575361|NCT01330420|144676735|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon signed-ranked test|||Due to the small sample size, the Wilcoxon signed-ranked test, a non-parametric statistical test, was used to detect outcome measure changes from pre-intervention to post-intervention||||<.001
72575362|NCT01330420|144676736|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon signed-ranked test|||Due to the small sample size, the Wilcoxon signed-ranked test, a non-parametric statistical test, was used to detect outcome measure changes from pre-intervention to post-intervention||||<.001
72575363|NCT01330420|144676737|SUPERIORITY_OR_OTHER||||||<|0.01||95.0|||||Wilcoxon signed-ranked test|||Due to the small sample size, the Wilcoxon signed-ranked test, a non-parametric statistical test, was used to detect outcome measure changes from pre-intervention to post-intervention||||<.01
72575364|NCT01330420|144676739|SUPERIORITY_OR_OTHER||||||<|0.01||95.0|||||Wilcoxon signed-ranked test|||Due to the small sample size, the Wilcoxon signed-ranked test, a non-parametric statistical test, was used to detect outcome measure changes from pre-intervention to post-intervention||||<.01
72409772|NCT03221257|144327998|SUPERIORITY||Mean Difference (Net)|-1.58||||0.1701|TWO_SIDED||||||ANCOVA|||||||0.1701
72409773|NCT03221257|144327999|SUPERIORITY||Mean Difference (Net)|-2.44||||0.3515|TWO_SIDED||||||ANCOVA|||||||0.3515
72409774|NCT03221257|144328000|SUPERIORITY||Mean Difference (Net)|-3.51||||0.1177|TWO_SIDED||||||ANCOVA|||||||0.1177
72409775|NCT03221257|144328001|SUPERIORITY||Mean Difference (Net)|-3.98||||0.1931|TWO_SIDED||||||ANCOVA|||||||0.1931
72409776|NCT03221257|144328002|SUPERIORITY||Mean Difference (Net)|121.3||||0.1811|TWO_SIDED||||||ANCOVA|||||||0.1811
72409777|NCT03221257|144328003|SUPERIORITY||Hazard Ratio (HR)|1.433||||0.3261|TWO_SIDED||||||Stratified log rank|||||||0.3261
72409778|NCT03221257|144328004|SUPERIORITY||Odds Ratio (OR)|1.6||||0.454|TWO_SIDED||||||Regression, Logistic|||||||0.454
72409779|NCT02797262|144328033|SUPERIORITY||Mean Difference (Net)|0.02||||0.57|TWO_SIDED|||||The threshold for statistical significance was p = 0.05.|Wilcoxon (Mann-Whitney)||Treatment Difference = Intervention - Control|Compared the IPAM score between two groups.||||0.57
72409780|NCT02797262|144328035|SUPERIORITY||Mean Difference (Net)|-0.02||||0.08|TWO_SIDED|||||The threshold for statistical significance was p = 0.05.|Mixed Models Analysis||Treatment Difference = Intervention - Control|Compared the change of the plasma HIV RNA levels during the intervention period (week 0-16) between two groups.||||0.08
72409781|NCT02797262|144328035|SUPERIORITY||Mean Difference (Net)|-0.02||||0.23|TWO_SIDED|||||The threshold for statistical significance was p = 0.05.|Mixed Models Analysis||Treatment Difference = Intervention - Control|Compared the change of the plasma HIV RNA levels during the post-intervention period (week 16-28) between two groups.||||0.23
72409782|NCT02797262|144328035|SUPERIORITY||Mean Difference (Net)|-0.73||||0.03|TWO_SIDED|||||The threshold for statistical significance was p = 0.05.|Mixed Models Analysis||Treatment Difference = Intervention - Control|Compared the plasma HIV RNA levels during week 4-28 between two groups.||||0.03
72540175|NCT00190684|144610008|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value is for CPRS ADHD Index Subscale within group|Wilcoxon signed-rank test|This test is for a significance of a location shift from zero of the change from baseline within a treatment group.||Tested was the null hypothesis that there would be no statistically significant difference between baseline and endpoint.||||<0.001
72540176|NCT00190684|144610008|SUPERIORITY_OR_OTHER||||||p<|0||95.0||||p-value is for CPRS Cognitive Subscale|Wilcoxon signed-rank test|This test is for a significance of a location shift from zero of the change from baseline within a treatment group.||Tested was the null hypothesis that there would be no statistically significant difference between baseline and endpoint.||||p<0.001
72575365|NCT03322930|144676740|OTHER||||||<|0.05||||||calculated from data|t-test, 2 sided||||mean sensitivity for group; Coefficient of Repeatability for multiple tests per patient|||<0.05
72627484|NCT01622296|144783832|SUPERIORITY_OR_OTHER|||||||0.23||||||Significant at p\<0.05|t-test, 2 sided|||Inferior Alveolar nerve injection - H(0): Lidocaine VAS score = Buffered Lidocaine VAS score. Based on data from medial trials of buffered anesthetic, a power calculation for sample size indicated that 20 subjects would provide a 90% change of detecting an effect size of 0.83 (a change of 0.83 standard deviations)||||0.23
72540177|NCT00190684|144610008|SUPERIORITY_OR_OTHER|||||||0.026||95.0||||p-value is for CPRS Hyperactive Subscale|Wilcoxon signed-rank test|This test is for a significance of a location shift from zero of the change from baseline within a treatment group.||Tested was the null hypothesis that there would be no statistically significant difference between baseline and endpoint.||||0.026
72540178|NCT00190684|144610008|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value is for CPRS Oppositional Subscale|Wilcoxon signed-rank test|This test is for a significance of a location shift from zero of the change from baseline within a treatment group.||Tested was the null hypothesis that there would be no statistically significant difference between baseline and endpoint.||||<0.001
72540179|NCT01155284|144610021|SUPERIORITY_OR_OTHER|||||||0.81|TWO_SIDED|||||The p value between treatment groups of C-peptide log (AUC+1) with covariate analysis adjusted for age, sex, baseline C-peptide concentration and duration of diabetes.|ANCOVA|||||||0.81
72540180|NCT01155284|144610022|SUPERIORITY_OR_OTHER|||||||0.869|TWO_SIDED||||||ANCOVA|||||||0.869
72540181|NCT02328404|144610029|SUPERIORITY_OR_OTHER|||||||0.001|||||||Chi-squared|Fisher Exact test was used||The participants in the treatment and placebo groups will be classified into two categories of prognosis (improved and not improved) and will be analyzed using Chi-square test, if Chi-square is higher than 3.84 (df=1) it will be statistically significant (p-value\</= 0.05)||||0.001
72409783|NCT00829621|144328045|SUPERIORITY_OR_OTHER||||||=|0.36|||||||t-test, 1 sided|||||||=0.36
72540182|NCT02328404|144610030|SUPERIORITY_OR_OTHER||||||<|0||||||A P-value \< 0.05 would be considered statistically significant.|t-test, 2 sided|||Both arms where evaluated at which paired t-test for the mean difference in the two arm was calculated . where the serum 25-OH Vit D3 was measured at 0 day time and after the end of the study. after that a paired t-test where applied for the difference for the 25-OH VitD3 levels between the two time points||||<0.000
72540183|NCT02328404|144610031|SUPERIORITY_OR_OTHER|||||||0.67|TWO_SIDED||||||t-test, 2 sided|||||||0.67
72540184|NCT02328404|144610032|SUPERIORITY_OR_OTHER|||||||0.51|TWO_SIDED||||||t-test, 2 sided|||||||0.51
72540185|NCT02328404|144610033|SUPERIORITY_OR_OTHER|||||||0.08|TWO_SIDED||||||t-test, 2 sided|||||||0.08
72540186|NCT02328404|144610034|SUPERIORITY_OR_OTHER|||||||0.01|TWO_SIDED||||||t-test, 2 sided|||||||0.01
72540187|NCT02328404|144610035|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED||||||Chi-squared|||||||0.001
72540188|NCT02328404|144610036|SUPERIORITY_OR_OTHER|||||||0.89|TWO_SIDED||||||t-test, 2 sided|||||||0.89
72540189|NCT02328404|144610037|SUPERIORITY_OR_OTHER|||||||0.6|TWO_SIDED||||||t-test, 2 sided|||||||0.60
72540190|NCT02328404|144610038|SUPERIORITY_OR_OTHER|||||||0.01|TWO_SIDED||||||t-test, 2 sided|||||||0.01
72540191|NCT02328404|144610039|SUPERIORITY_OR_OTHER|||||||0.35|TWO_SIDED||||||t-test, 2 sided|||||||0.35
72540192|NCT02328404|144610040|SUPERIORITY_OR_OTHER|||||||0.65|||||||t-test, 2 sided|||||||0.65
72540193|NCT02328404|144610041|SUPERIORITY_OR_OTHER|||||||0.25|||||||t-test, 2 sided|||||||0.25
72540194|NCT02328404|144610042|SUPERIORITY_OR_OTHER|||||||0.04|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.04
72540195|NCT02328404|144610043|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.02
72540196|NCT04529499|144610044|SUPERIORITY|||||||0.67|||||||Log Rank|||||||0.67
72540197|NCT04529499|144610044|SUPERIORITY||Cox Proportional Hazard|0.991|||||TWO_SIDED|95.0|0.767|1.28|||||Favipiravir + supportive care in numerator and Placebo+ Supportive care in denominator for CPH ratio analysis|||1.280|0.767|
72540198|NCT04529499|144610045|SUPERIORITY|||||||0.34|||||||Fisher Exact|||||||0.34
72540199|NCT01494649|144610062|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.1||||0.2294|TWO_SIDED|95.0|-0.26|0.06||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|The model included treatment as a fixed factor and basline Schiff score as a covariate.|Difference was calculated as adjusted mean change from baseline in 0.454% stannous fluoride toothpaste minus 0.76% sodium fluoride toothpaste. Negative difference favoured stannous fluoride toothpaste.|Null hypothesis is no difference between treatments. Tests were 2-sided.||0.06|-0.26|0.2294
72540200|NCT01494649|144610063|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.12||||0.1792||95.0|-0.3|0.06||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment was a fixed factor and baseline Schiff Sensitivity Score was a covariate.|Difference was calculated as adjusted mean change from baseline in 0.454% stannous fluoride toothpaste minus 0.76% sodium fluoride toothpaste. Negative difference favored stannous fluoride toothpaste.|Null hypothesis was no difference between treatments. Tests were 2-sided.||0.06|-0.30|0.1792
72540201|NCT01494649|144610064|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.52|||<|0.0001|TWO_SIDED|95.0|-0.74|-0.3||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment was a fixed factor and baseline Schiff Sensitivity Score was a covariate.|Difference was calculated as adjusted mean change from baseline in 0.454% stannous fluoride toothpaste minus 0.76% sodium fluoride toothpaste. Negative difference favored stannous fluoride toothpaste.|Null hypothesis was no difference between treatments. Tests were 2-sided.||-0.30|-0.74|<0.0001
72627485|NCT01622296|144783832|SUPERIORITY_OR_OTHER|||||||0.57||||||Significant at p\<0.05|t-test, 2 sided|||Long buccal nerve injection - H(0): Lidocaine VAS score = Buffered Lidocaine VAS score. Based on data from medial trials of buffered anesthetic, a power calculation for sample size indicated that 20 subjects would provide a 90% change of detecting an effect size of 0.83 (a change of 0.83 standard deviations)||||0.57
72627486|NCT00372957|144783844|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.1|||||TWO_SIDED|95.0|-2.28|-1.93|||Double-delta analysis||The point estimate is the least square mean difference between placebo and GW 823093C 15 mg.|AUC(0-12 hr), Day 7||-1.93|-2.28|
72627487|NCT00372957|144783844|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.16|||||TWO_SIDED|95.0|-2.33|-1.98|||Double-delta analysis||The point estimate is the least square mean difference between placebo and GW 823093C 30 mg.|AUC(0-12 hr), Day 7||-1.98|-2.33|
72627488|NCT00372957|144783844|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.98|||||TWO_SIDED|95.0|-2.15|-1.82|||Double-delta analysis||The point estimate is the least square mean difference between placebo and GW 823093C 15 mg.|AUC(0-24 hr), Day 7||-1.82|-2.15|
72627489|NCT00372957|144783844|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.12|||||TWO_SIDED|95.0|-2.28|-1.95|||Double-delta analysis||The point estimate is the least square mean difference between placebo and GW 823093C 30 mg.|AUC(0-24 hr), Day 7||-1.95|-2.28|
72540202|NCT01494649|144610065|SUPERIORITY_OR_OTHER||Mean adjusted difference|-0.08||||0.9445|TWO_SIDED|95.0|-2.49|2.32||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment was a fixed factor and baseline Tactile Threshold score was a covariate.|Difference was calculated as adjusted mean change from baseline in 0.454% stannous fluoride toothpaste minus 0.76% sodium fluoride toothpaste. Negative difference favored stannous fluoride toothpaste.|Null hypothesis was no difference between treatments. Tests were 2-sided.||2.32|-2.49|0.9445
72540203|NCT01494649|144610066|SUPERIORITY_OR_OTHER||Adjusted mean|-2.07||||0.22|TWO_SIDED|95.0|-5.38|1.25||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment was a fixed factor and baseline tactile threshold score was a covariate.|Difference was calculated as adjusted mean change from baseline in 0.454% stannous fluoride toothpaste minus 0.76% sodium fluoride toothpaste. Negative difference favored stannous fluoride toothpaste.|Null hypothesis was no difference between treatments. Tests were 2-sided.||1.25|-5.38|0.220
72540204|NCT01494649|144610067|SUPERIORITY_OR_OTHER||Mean adjusted difference|8.69||||0.0004|TWO_SIDED|95.0|3.96|13.43||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment was a fixed factor and baseline tactile threshold score was a covariate.|Difference was calculated as adjusted mean change from baseline in 0.454% stannous fluoride toothpaste minus 0.76% sodium fluoride toothpaste. Negative difference favored stannous fluoride toothpaste.|Null hypothesis was no difference between treatments. Tests were 2-sided.||13.43|3.96|0.0004
72540205|NCT03467971|144610068|EQUIVALENCE|Bio-equivalence Analysis was performed with Equivalence Acceptance Range for 90% Confidence Interval (CI) as 80.0% - 125.0%.|Ratio of mean values|175.6652|||||TWO_SIDED|90.0|153.779|200.6664||||||Statistical Analysis for Metformin||200.6664|153.7790|
72540206|NCT03467971|144610068|EQUIVALENCE|Bio-equivalence Analysis was performed with Equivalence Acceptance Range for 90% Confidence Interval (CI) as 80.0% - 125.0%.|Ratio of mean values|104.457|||||TWO_SIDED|90.0|97.766|111.606||||||Statistical Analysis for Gliclazide||111.6060|97.7660|
72540207|NCT03467971|144610069|EQUIVALENCE|Bio-equivalence Analysis was performed with Equivalence Acceptance Range for 90% Confidence Interval (CI) as 80.0% - 125.0%.|Ratio of mean values|180.7734|||||TWO_SIDED|90.0|157.0135|208.1287||||||Statistical Analysis for Metformin||208.1287|157.0135|
72540208|NCT03467971|144610069|EQUIVALENCE|Bio-equivalence Analysis was performed with Equivalence Acceptance Range for 90% Confidence Interval (CI) as 80.0% - 125.0%.|Ratio of mean values|105.0818|||||TWO_SIDED|90.0|98.0047|112.6699||||||Statistical Analysis for Gliclazide||112.6699|98.0047|
72540209|NCT03467971|144610070|EQUIVALENCE|Bio-equivalence Analysis was performed with Equivalence Acceptance Range for 90% Confidence Interval (CI) as 80.0% - 125.0%.|Ratio of mean values|127.7779|||||TWO_SIDED|90.0|110.2732|148.0612||||||Statistical Analysis for Metformin||148.0612|110.2732|
72575366|NCT01687244|144676741|SUPERIORITY_OR_OTHER||HGRF survival at 12 months|33.3|||||TWO_SIDED|90.0|16.8|53.6||Not applicable: the primary analysis was a calculation of a confidence interval||||The primary efficacy endpoint was the incidence of high-grade recurrence-free survival at 12 months. The proportion of patients achieving high-grade recurrence-free survival at 12 months was reported for each dose group, together with an exact 90% confidence interval for the proportion||53.6|16.8|
72575367|NCT01687244|144676741|SUPERIORITY_OR_OTHER||HGRF survival at 12 months|36.8|||||TWO_SIDED|90.0|18.8|58.2|||||The proportion of subjects achieving high-grade recurrence-free survival at 12 months|The primary efficacy endpoint was the incidence of high-grade recurrence-free survival at 12 months. The proportion of patients achieving high-grade recurrence-free survival at 12 months was reported for each dose group, together with an exact 90% confidence interval for the proportion.||58.2|18.8|
72575368|NCT02373189|144676762|SUPERIORITY|||||||0.05||||||The P-value indicated above is calculated.|paired t-test|means at pre and post treatment were compared within subject.||||||0.05
72575369|NCT02373189|144676763|SUPERIORITY|||||||0.05|||||||t-test, 2 sided|||||||0.05
72627490|NCT00372957|144783845|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.87|||||TWO_SIDED|95.0|2.33|5.41|||Double-delta analysis||he point estimate is the least square mean difference between placebo and GW 823093C 15 mg.|AUC(0-12 hr), Day 7||5.41|2.33|
72540210|NCT03467971|144610070|EQUIVALENCE|Bio-equivalence Analysis was performed with Equivalence Acceptance Range for 90% Confidence Interval (CI) as 80.0% - 125.0%.|Ratio of mean values|105.4183|||||TWO_SIDED|90.0|94.5723|117.5081||||||Statistical Analysis for Gliclazide||117.5081|94.5723|
72540211|NCT01236053|144610120|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.15||||0.0002|TWO_SIDED|95.0|1.07|1.24|||Conditional Logistic Regression||"Comparison: Ever (with 2 year lag) and Never (with 2 year lag)"|||1.24|1.07|0.0002
72575370|NCT02151877|144676767|OTHER||||||>|0.05||||||This test applies to the first marker, cardiac troponin I.|t-test, 2 sided|||Null: mean cardiac troponin I changes in the NO group = mean cardiac troponin I changes in the control||||>0.05
72575371|NCT02151877|144676768|OTHER||||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||Null: NO group fluid balances are the same as the control||||>0.05
72575372|NCT03185013|144676773|SUPERIORITY|Superiority was concluded if the one-sided p-value was \<0.025 and the corresponding lower bound of the 95% CI exceeded zero (0).|Difference in percentage|11.4||||0.029|TWO_SIDED|95.0|-0.4|21.2|||Miettinen and Nurminen method|||||21.2|-0.4|0.029
72575373|NCT03185013|144676775|SUPERIORITY|Superiority was concluded if the lower bound of the 95% CI exceeded 0.|Difference in percentage|12.8|||||TWO_SIDED|95.0|-0.6|24.5||||||||24.5|-0.6|
72575374|NCT03185013|144676776|SUPERIORITY|Superiority was concluded if the lower bound of the 95% CI exceeded 0.|Difference in percentage|18.2|||||TWO_SIDED|95.0|5.1|29.4||||||||29.4|5.1|
72627491|NCT00372957|144783845|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.21|||||TWO_SIDED|95.0|3.7|6.73|||Double-delta analysis||The point estimate is the least square mean difference between placebo and GW 823093C 30 mg.|AUC(0-12 hr), Day 7||6.73|3.70|
72627492|NCT00372957|144783845|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.22|||||TWO_SIDED|95.0|1.9|4.54|||Double-delta analysis||The point estimate is the least square mean difference between placebo and GW 823093C 15 mg.|AUC(0-24 hr), Day 7||4.54|1.90|
72409784|NCT02066298|144328089|SUPERIORITY|||||||0.14|||||||exact binomial test|a priori threshold for significance was 0.025||The null hypothesis was that, among those participants for which either mometasone is not equal to placebo, the proportion for which mometasone is superior to placebo is equal to the proportion for which placebo is superior to mometasone. The trial was designed to provide power of 0.85 for a 0.20 difference between the proportions being compared at a significance level of 0.025.||||0.14
72627493|NCT00372957|144783845|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.39|||||TWO_SIDED|95.0|3.1|5.68|||Double-delta analysis||The point estimate is the least square mean difference between placebo and GW 823093C 30 mg.|AUC(0-24 hr), Day 7||5.68|3.10|
72409785|NCT02066298|144328089|SUPERIORITY|||||||0.029||||||a priori threshold for significance was 0.025|exact binomial test|||The null hypothesis was that, among those participants for which either tiotropium is not equal to placebo, the proportion for which tiotropium is superior to placebo is equal to the proportion for which placebo is superior to tiotropium. The trial was designed to provide power of 0.85 for a 0.20 difference between the proportions being compared at a significance level of 0.025.||||0.029
72409786|NCT02066298|144328089|SUPERIORITY|||||||0.001||||||this analysis is considered exploratory|exact binomial test|||The null hypothesis was that, among those participants for which either mometasone is not equal to placebo, the proportion for which mometasone is superior to placebo is equal to the proportion for which placebo is superior to mometasone. This was an exploratory analysis and there were no power considerations.||||0.001
72409787|NCT02066298|144328089|SUPERIORITY|||||||0.45||||||this analysis is considered exploratory|exact binomial test|||The null hypothesis was that, among those participants for which either tiotropium is not equal to placebo, the proportion for which tiotropium is superior to placebo is equal to the proportion for which placebo is superior to tiotropium. This was an exploratory analysis and there were no power considerations.||||0.45
72409788|NCT02033889|144328095|SUPERIORITY||Difference in Least Squares Means|-0.88|||<|0.001|TWO_SIDED|95.0|-1.05|-0.71|||Constrained Longitudinal Data Analysis||||Based on Constrained Longitudinal Data Analysis (cLDA) model with fixed effects for treatment, time, prior anti hyperglycemic medication (Metformin monotherapy or Metformin + another anti-hyperglycemic agent, AHA), baseline eGFR (continuous), menopausal status. Time was treated as a categorical variable.|-0.71|-1.05|<0.001
72409789|NCT02033889|144328095|SUPERIORITY||Difference in Least Squares Means|-0.7|||<|0.001|TWO_SIDED|95.0|-0.87|-0.53|||Constrained Longitudinal Data Analysis||||Based on cLDA model with fixed effects for treatment, time, prior anti hyperglycemic medication (Metformin monotherapy or Metformin + another anti-hyperglycemic agent, AHA), baseline eGFR (continuous), menopausal status. Time was treated as a categorical variable.|-0.53|-0.87|<0.001
72409790|NCT02033889|144328097|OTHER||Difference in % vs Placebo/Glimepiride|1.5|||||TWO_SIDED|95.0|-2.1|5.4|||||||Miettinen \& Nurminen method was used to construct the 95% CI|5.4|-2.1|
72409791|NCT02033889|144328097|OTHER||Difference in % vs Placebo/Glimepiride|1.0|||||TWO_SIDED|95.0|-2.5|4.7|||||||Miettinen \& Nurminen method was used to construct the 95% CI|4.7|-2.5|
72540212|NCT01236053|144610120|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.07||||0.0976|TWO_SIDED|95.0|0.99|1.15|||Conditional Logistic Regression||"Comparison: Ever (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy."|||1.15|0.99|0.0976
72409792|NCT02033889|144328098|SUPERIORITY||Difference in Least Squares Means|-38.25|||<|0.001|TWO_SIDED|95.0|-44.5|-31.99|||Constrained Longitudinal Data Analysis||||Based on the cLDA model with fixed effects for treatment, time, prior antihyperglycemic medication (metformin monotherapy or metformin + another AHA), baseline eGFR (continuous), menopausal status. Time was treated as a categorical variable.|-31.99|-44.50|<0.001
72540213|NCT01236053|144610120|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.29|||<|0.0001|TWO_SIDED|95.0|1.23|1.36|||Conditional Logistic Regression||"Comparison: Ever (without 2 year lag) and Never (without 2 year lag)"|||1.36|1.23|<0.0001
72540214|NCT01236053|144610120|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.19|||<|0.0001|TWO_SIDED|95.0|1.13|1.26|||Conditional Logistic Regression||"Comparison: Ever (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy."|||1.26|1.13|<0.0001
72540215|NCT01236053|144610121|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.09||||0.1468|TWO_SIDED|95.0|0.97|1.23|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag)."|||1.23|0.97|0.1468
72540216|NCT01236053|144610121|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.01||||0.8545|TWO_SIDED|95.0|0.9|1.14|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy."|||1.14|0.90|0.8545
72540217|NCT01236053|144610121|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.37|||<|0.0001|TWO_SIDED|95.0|1.27|1.48|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag)."|||1.48|1.27|<0.0001
72540218|NCT01236053|144610121|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.27|||<|0.0001|TWO_SIDED|95.0|1.18|1.37|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy."|||1.37|1.18|<0.0001
72540219|NCT01236053|144610121|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.24||||0.0033|TWO_SIDED|95.0|1.07|1.43|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag)."|||1.43|1.07|0.0033
72540220|NCT01236053|144610121|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.16||||0.0474|TWO_SIDED|95.0|1.0|1.33|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy."|||1.33|1.00|0.0474
72540221|NCT01236053|144610121|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.29|||<|0.0001|TWO_SIDED|95.0|1.16|1.43|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag)."|||1.43|1.16|<0.0001
72627494|NCT00372957|144783846|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.56|||||TWO_SIDED|95.0|-6.0|2.89|||Double-delta analysis||The point estimate is the least square mean difference between placebo and GW 823093C 15 mg.|AUC(0-12 hr), Day 7||2.89|-6.00|
72627495|NCT00372957|144783846|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.21|||||TWO_SIDED|95.0|-3.3|5.72|||Double-delta analysis||The point estimate is the least square mean difference between placebo and GW 823093C 30 mg.|AUC(0-12 hr), Day 7||5.72|-3.30|
72627496|NCT00372957|144783846|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.35|||||TWO_SIDED|95.0|-5.2|2.5|||Double-delta analysis||The point estimate is the least square mean difference between placebo and GW 823093C 15 mg.|AUC(0-24 hr), Day 7||2.50|-5.20|
72627497|NCT00372957|144783846|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.48|||||TWO_SIDED|95.0|-2.47|5.43|||Double-delta analysis||The point estimate is the least square mean difference between placebo and GW 823093C 30 mg.|AUC(0-24 hr), Day 7||5.43|-2.47|
72627498|NCT00372957|144783847|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.1|||||TWO_SIDED|95.0|-20.4|4.2|||Double-delta analysis||The point estimate is the least square mean difference between placebo and GW 823093C 15 mg.|AUC(0-12 hr), Day 7||4.2|-20.4|
72627499|NCT00372957|144783847|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.2|||||TWO_SIDED|95.0|-28.4|-3.9|||Double-delta analysis||The point estimate is the least square mean difference between placebo and GW 823093C 30 mg.|AUC(0-12 hr), Day 7||-3.9|-28.4|
72627500|NCT00372957|144783847|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.9|||||TWO_SIDED|95.0|-23.1|1.4|||Double-delta analysis||The point estimate is the least square mean difference between placebo and GW 823093C 15 mg.|AUC(0-24 hr), Day 7||1.4|-23.1|
72627501|NCT00372957|144783847|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.6|||||TWO_SIDED|95.0|-27.9|-3.3|||Double-delta analysis||The point estimate is the least square mean difference between placebo and GW 823093C 30 mg.|AUC(0-24 hr), Day 7||-3.3|-27.9|
72627502|NCT00372957|144783848|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.26|||||TWO_SIDED|95.0|-0.64|1.16|||Double-delta analysis||The point estimate is the least square mean difference between placebo and GW 823093C 15 mg.|AUC(0-12 hr), Day 7||1.16|-0.64|
72540222|NCT01236053|144610121|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.19||||0.0008|TWO_SIDED|95.0|1.08|1.32|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy."|||1.32|1.08|0.0008
72627503|NCT00372957|144783848|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.43|||||TWO_SIDED|95.0|-0.47|1.32|||Double-delta analysis||The point estimate is the least square mean difference between placebo and GW 823093C 30 mg.|AUC(0-12 hr), Day 7||1.32|-0.47|
72627504|NCT00372957|144783848|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.35|||||TWO_SIDED|95.0|-0.37|1.07|||Double-delta analysis||The point estimate is the least square mean difference between placebo and GW 823093C 15 mg.|AUC(0-24 hr), Day 7||1.07|-0.37|
72409793|NCT02033889|144328098|SUPERIORITY||Difference in the Least Squares Means|-26.69|||<|0.001|TWO_SIDED|95.0|-32.9|-20.48|||Constrained Longitudinal Data Analysis||||Based on the cLDA model with fixed effects for treatment, time, prior antihyperglycemic medication (metformin monotherapy or metformin + another AHA), baseline eGFR (continuous), menopausal status. Time was treated as a categorical variable.|-20.48|-32.90|<0.001
72540223|NCT01236053|144610121|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.17||||0.019|TWO_SIDED|95.0|1.03|1.33|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag)."|||1.33|1.03|0.0190
72540224|NCT01236053|144610121|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.07||||0.3366|TWO_SIDED|95.0|0.94|1.21|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy."|||1.21|0.94|0.3366
72540225|NCT01236053|144610121|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.19||||0.0001|TWO_SIDED|95.0|1.09|1.31|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag)."|||1.31|1.09|0.0001
72409794|NCT02033889|144328099|SUPERIORITY||Difference in Least Squares Means|-1.6|||<|0.001|TWO_SIDED|95.0|-2.16|-1.03|||Constrained Longitudinal Data Analysis||||Based on the cLDA model with fixed effects for treatment, time, prior antihyperglycemic medication (metformin monotherapy or metformin + another AHA), baseline eGFR (continuous), menopausal status. Time was treated as a categorical variable.|-1.03|-2.16|<0.001
72540226|NCT01236053|144610121|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.1||||0.0464|TWO_SIDED|95.0|1.0|1.2|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy."|||1.20|1.00|0.0464
72540227|NCT01236053|144610122|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.11||||0.1194|TWO_SIDED|95.0|0.97|1.26|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag)."|||1.26|0.97|0.1194
72540228|NCT01236053|144610122|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.03||||0.7004|TWO_SIDED|95.0|0.9|1.17|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy."|||1.17|0.90|0.7004
72540229|NCT01236053|144610122|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.37|||<|0.0001|TWO_SIDED|95.0|1.26|1.49|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag)."|||1.49|1.26|<0.0001
72627505|NCT00372957|144783848|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.48|||||TWO_SIDED|95.0|-0.24|1.21|||Double-delta analysis||The point estimate is the least square mean difference between placebo and GW 823093C 30 mg.|AUC(0-24 hr), Day 7||1.21|-0.24|
72627506|NCT00372957|144783849|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.9|||||TWO_SIDED|95.0|-40.7|0.9|||Double-delta analysis||The point estimate is the least square mean difference between placebo and GW 823093C 15 mg.|AUC(0-12 hr), Day 7||0.9|-40.7|
72627507|NCT00372957|144783849|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.0|||||TWO_SIDED|95.0|-29.8|11.7|||Double-delta analysis||The point estimate is the least square mean difference between placebo and GW 823093C 30 mg.|AUC(0-12 hr), Day 7||11.7|-29.8|
72627508|NCT00372957|144783849|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.9|||||TWO_SIDED|95.0|-33.2|1.4|||Double-delta analysis||The point estimate is the least square mean difference between placebo and GW 823093C 15 mg.|AUC(0-24 hr), Day 7||1.4|-33.2|
72627509|NCT00372957|144783849|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.2|||||TWO_SIDED|95.0|-23.4|11.1|||Double-delta analysis||The point estimate is the least square mean difference between placebo and GW 823093C 30 mg.|AUC(0-24 hr), Day 7||11.1|-23.4|
72627510|NCT02431325|144783868|SUPERIORITY|||||||0.01|||||||ANCOVA|||||||0.01
72627511|NCT02431325|144783869|SUPERIORITY|||||||0.04|||||||t-test, 2 sided|||||||0.04
72627512|NCT02431325|144783870|SUPERIORITY|||||||0.87|||||||t-test, 2 sided|||||||0.87
72627513|NCT02431325|144783871|SUPERIORITY|||||||0.047|||||||t-test, 2 sided|||||||0.047
72409795|NCT02033889|144328099|SUPERIORITY||Difference in Least Squares Means|-1.67|||<|0.001|TWO_SIDED|95.0|-2.24|-1.11|||Constrained Longitudinal Data Analysis||||Based on the cLDA model with fixed effects for treatment, time, prior antihyperglycemic medication (metformin monotherapy or metformin + another AHA), baseline eGFR (continuous), menopausal status. Time was treated as a categorical variable.|-1.11|-2.24|<0.001
72409796|NCT02033889|144328100|SUPERIORITY||Adjusted Odds Ratio Relative to Placebo|4.48|||<|0.001|TWO_SIDED|95.0|2.64|7.62|||Regression, Logistic||||Adjusted odds ratio based on a logistic regression model fitted with fixed effects for treatment, prior antihyperglycemic medication (metformin monotherapy or metformin + another AHA), menopausal status, covariates for baseline A1C and baseline eGFR (continuous). Missing data imputed using a multiple imputation procedure based on cLDA prediction modeling with fixed effects as in the primary analysis, which allows for participants with missing data to be included in the analysis.|7.62|2.64|<0.001
72409797|NCT02033889|144328100|SUPERIORITY||Adjusted Odds Ratio Relative to Placebo|3.03|||<|0.001|TWO_SIDED|95.0|1.81|5.06|||Regression, Logistic||||Adjusted odds ratio based on a logistic regression model fitted with fixed effects for treatment, prior antihyperglycemic medication (metformin monotherapy or metformin + another AHA), menopausal status, covariates for baseline A1C and baseline eGFR (continuous). Missing data imputed using a multiple imputation procedure based on cLDA prediction modeling with fixed effects as in the primary analysis, which allows for participants with missing data to be included in the analysis.|5.06|1.81|<0.001
72409798|NCT02033889|144328101|SUPERIORITY||Difference in Least Squares Means|-4.5|||<|0.001|TWO_SIDED|95.0|-6.81|-2.19|||Constrained Longitudinal Data Analysis||||Based on the cLDA model with fixed effects for treatment, time, prior antihyperglycemic medication (metformin monotherapy or metformin + another AHA), baseline eGFR (continuous), menopausal status, and the interaction of time by treatment. Time was treated as a categorical variable.|-2.19|-6.81|<0.001
72540230|NCT01236053|144610122|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.26|||<|0.0001|TWO_SIDED|95.0|1.16|1.38|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy."|||1.38|1.16|<0.0001
72540231|NCT01236053|144610122|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.17||||0.0134|TWO_SIDED|95.0|1.03|1.34|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag)."|||1.34|1.03|0.0134
72540232|NCT01236053|144610122|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.1||||0.1592|TWO_SIDED|95.0|0.96|1.25|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy."|||1.25|0.96|0.1592
72540233|NCT01236053|144610122|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.35|||<|0.0001|TWO_SIDED|95.0|1.24|1.47|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag)."|||1.47|1.24|<0.0001
72540234|NCT01236053|144610122|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.25|||<|0.0001|TWO_SIDED|95.0|1.14|1.36|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy."|||1.36|1.14|<0.0001
72540235|NCT01236053|144610122|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.17||||0.0131|TWO_SIDED|95.0|1.03|1.33|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag)."|||1.33|1.03|0.0131
72540236|NCT01236053|144610122|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.07||||0.2731|TWO_SIDED|95.0|0.95|1.22|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy."|||1.22|0.95|0.2731
72540237|NCT01236053|144610122|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.16||||0.0012|TWO_SIDED|95.0|1.06|1.28|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag)."|||1.28|1.06|0.0012
72575375|NCT03185013|144676777|SUPERIORITY|Superiority was concluded if the lower bound of the 95% CI exceeded 0.|Difference in percentage|13.5|||||TWO_SIDED|95.0|1.7|23.5||||||||23.5|1.7|
72540238|NCT01236053|144610122|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.07||||0.1477|TWO_SIDED|95.0|0.98|1.17|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy."|||1.17|0.98|0.1477
72540239|NCT01236053|144610123|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.2||||0.0369|TWO_SIDED|95.0|1.01|1.41|||Conditional Logistic Regression||"Comparison: \> 1 year (with 2 year lag) and Never (with 2 year lag)."|||1.41|1.01|0.0369
72575376|NCT03185013|144676778|SUPERIORITY|Superiority was concluded if the lower bound of the 95% CI exceeded 0.|Difference in percentage|11.8|||||TWO_SIDED|95.0|1.5|20.3||||||||20.3|1.5|
72409799|NCT02033889|144328101|SUPERIORITY||Difference in Least Squares Means|-3.68||||0.002|TWO_SIDED|95.0|-5.96|-1.39|||Constrained Longitudinal Data Analysis||||Based on the cLDA model with fixed effects for treatment, time, prior antihyperglycemic medication (metformin monotherapy or metformin + another AHA), baseline eGFR (continuous), menopausal status, and the interaction of time by treatment. Time was treated as a categorical variable.|-1.39|-5.96|0.002
72540240|NCT01236053|144610123|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.09||||0.3132|TWO_SIDED|95.0|0.92|1.29|||Conditional Logistic Regression||"Comparison: \> 1 year (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy."|||1.29|0.92|0.3132
72540241|NCT01236053|144610123|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.12||||0.0762|TWO_SIDED|95.0|0.99|1.26|||Conditional Logistic Regression||"Comparison: \> 1 year (without 2 year lag) and Never (without 2 year lag)."|||1.26|0.99|0.0762
72540242|NCT01236053|144610123|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.02||||0.7243|TWO_SIDED|95.0|0.91|1.15|||Conditional Logistic Regression||"Comparison: \> 1 year (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy."|||1.15|0.91|0.7243
72540243|NCT01236053|144610123|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.27||||0.0775|TWO_SIDED|95.0|0.97|1.65|||Conditional Logistic Regression||"Comparison: \> 2 years (with 2 year lag) and Never (with 2 year lag)."|||1.65|0.97|0.0775
72575377|NCT03185013|144676779|SUPERIORITY|Superiority was concluded if the lower bound of the 95% CI exceeded 0.|Difference in percentage|-1.7|||||TWO_SIDED|95.0|-11.5|10.3||||||||10.3|-11.5|
72627514|NCT02431325|144783872|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
72540244|NCT01236053|144610123|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.16||||0.2649|TWO_SIDED|95.0|0.89|1.52|||Conditional Logistic Regression||"Comparison: \> 2 years (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy."|||1.52|0.89|0.2649
72540245|NCT01236053|144610123|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.21||||0.0257|TWO_SIDED|95.0|1.02|1.43|||Conditional Logistic Regression||"Comparison: \> 2 years (without 2 year lag) and Never (without 2 year lag)."|||1.43|1.02|0.0257
72540246|NCT01236053|144610123|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.1||||0.254|TWO_SIDED|95.0|0.93|1.3|||Conditional Logistic Regression||"Comparison: \> 2 years (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy."|||1.30|0.93|0.2540
72540247|NCT01236053|144610123|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.15||||0.5141|TWO_SIDED|95.0|0.76|1.75|||Conditional Logistic Regression||"Comparison: \> 3 years (with 2 year lag) and Never (with 2 year lag)."|||1.75|0.76|0.5141
72540248|NCT01236053|144610123|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.05||||0.8208|TWO_SIDED|95.0|0.69|1.6|||Conditional Logistic Regression||"Comparison: \> 3 years (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy."|||1.60|0.69|0.8208
72540249|NCT01236053|144610123|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.27||||0.0562|TWO_SIDED|95.0|0.99|1.62|||Conditional Logistic Regression||"Comparison: \> 3 years (without 2 year lag) and Never (without 2 year lag)."|||1.62|0.99|0.0562
72540250|NCT01236053|144610123|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.15||||0.2596|TWO_SIDED|95.0|0.9|1.47|||Conditional Logistic Regression||"Comparison: \> 3 years (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy."|||1.47|0.90|0.2596
72540251|NCT01236053|144610124|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.12||||0.0709|TWO_SIDED|95.0|0.99|1.28|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag)."|||1.28|0.99|0.0709
72540252|NCT01236053|144610124|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.05||||0.4996|TWO_SIDED|95.0|0.92|1.19|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy."|||1.19|0.92|0.4996
72540253|NCT01236053|144610124|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.34|||<|0.0001|TWO_SIDED|95.0|1.23|1.45|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag)."|||1.45|1.23|<0.0001
72540254|NCT01236053|144610124|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.24|||<|0.0001|TWO_SIDED|95.0|1.14|1.35|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy."|||1.35|1.14|<0.0001
72540255|NCT01236053|144610124|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.2||||0.0062|TWO_SIDED|95.0|1.05|1.36|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag)."|||1.36|1.05|0.0062
72540256|NCT01236053|144610124|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.11||||0.1144|TWO_SIDED|95.0|0.98|1.26|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy."|||1.26|0.98|0.1144
72540257|NCT01236053|144610124|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.42|||<|0.0001|TWO_SIDED|95.0|1.3|1.55|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag)."|||1.55|1.30|<0.0001
72627515|NCT02431325|144783873|SUPERIORITY|||||||0.07|||||||t-test, 2 sided|||||||0.07
72627516|NCT02431325|144783874|SUPERIORITY|||||||0.68|||||||t-test, 2 sided|||||||0.68
72540258|NCT01236053|144610124|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.31|||<|0.0001|TWO_SIDED|95.0|1.2|1.43|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy."|||1.43|1.20|<0.0001
72540259|NCT01236053|144610124|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.14||||0.0469|TWO_SIDED|95.0|1.0|1.29|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag)."|||1.29|1.00|0.0469
72540260|NCT01236053|144610124|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.04||||0.5169|TWO_SIDED|95.0|0.92|1.19|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy."|||1.19|0.92|0.5169
72540261|NCT01236053|144610124|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.13||||0.0103|TWO_SIDED|95.0|1.03|1.24|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag)."|||1.24|1.03|0.0103
72540262|NCT01236053|144610124|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.04||||0.4182|TWO_SIDED|95.0|0.95|1.14|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy."|||1.14|0.95|0.4182
72540263|NCT01236053|144610125|SUPERIORITY_OR_OTHER||Unadjusted Odds Ratio|0.65||||0.3597|TWO_SIDED|95.0|0.26|1.62|||Conditional Logistic Regression||"Comparison: Ever (with 2 year lag) and Never (with 2 year lag)."|||1.62|0.26|0.3597
72540264|NCT01236053|144610125|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.54||||0.1845|TWO_SIDED|95.0|0.21|1.34|||Conditional Logistic Regression||"Comparison: Ever (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, upper GI disorder, acid-suppressing drugs."|||1.34|0.21|0.1845
72540265|NCT01236053|144610125|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.03||||0.9142|TWO_SIDED|95.0|0.58|1.84|||Conditional Logistic Regression||"Comparison: Ever (without 2 year lag) and Never (without 2 year lag)."|||1.84|0.58|0.9142
72627517|NCT02431325|144783875|SUPERIORITY|||||||0.49|||||||t-test, 2 sided|||||||0.49
72627518|NCT02431325|144783876|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||||||1.00
72627519|NCT02431325|144783877|SUPERIORITY|||||||0.04|||||||t-test, 2 sided|||||||0.04
72627520|NCT02431325|144783878|SUPERIORITY|||||||0.07|||||||t-test, 2 sided|||||||0.07
72627521|NCT02431325|144783879|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||||||1.00
72627522|NCT02431325|144783880|SUPERIORITY|||||||0.34|||||||Wilcoxon (Mann-Whitney)|||||||0.34
72627523|NCT02431325|144783881|SUPERIORITY|||||||0.33|||||||t-test, 2 sided|||||||0.33
72540266|NCT01236053|144610125|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.87||||0.6524|TWO_SIDED|95.0|0.49|1.57|||Conditional Logistic Regression||"Comparison: Ever (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, upper GI disorder, acid-suppressing drugs."|||1.57|0.49|0.6524
72540267|NCT01236053|144610126|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.53||||0.2875|TWO_SIDED|95.0|0.17|1.7|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag)."|||1.70|0.17|0.2875
72540268|NCT01236053|144610126|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.47||||0.2042|TWO_SIDED|95.0|0.15|1.51|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, upper GI disorder, acid-suppressing drugs."|||1.51|0.15|0.2042
72540269|NCT01236053|144610126|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.75||||0.4733|TWO_SIDED|95.0|0.38|8.06|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag)."|||8.06|0.38|0.4733
72540270|NCT01236053|144610126|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.24||||0.7867|TWO_SIDED|95.0|0.26|5.85|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, upper GI disorder, acid-suppressing drugs."|||5.85|0.26|0.7867
72540271|NCT01236053|144610126|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.53||||0.0049|TWO_SIDED|95.0|1.47|8.5|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag)."|||8.50|1.47|0.0049
72540272|NCT01236053|144610126|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.87||||0.0218|TWO_SIDED|95.0|1.17|7.08|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, upper GI disorder, acid-suppressing drugs."|||7.08|1.17|0.0218
72540273|NCT01236053|144610126|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.89||||0.849|TWO_SIDED|95.0|0.27|2.92|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag)."|||2.92|0.27|0.8490
72540274|NCT01236053|144610126|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.74||||0.6263|TWO_SIDED|95.0|0.22|2.46|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, upper GI disorder, acid-suppressing drugs."|||2.46|0.22|0.6263
72540275|NCT01236053|144610126|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.61||||0.4122|TWO_SIDED|95.0|0.19|1.97|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag)."|||1.97|0.19|0.4122
72540276|NCT01236053|144610126|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.51||||0.2642|TWO_SIDED|95.0|0.16|1.66|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, upper GI disorder, acid-suppressing drugs."|||1.66|0.16|0.2642
72540277|NCT01236053|144610127|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.87||||0.7891|TWO_SIDED|95.0|0.31|2.43|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag)."|||2.43|0.31|0.7891
72540278|NCT01236053|144610127|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.77||||0.6216|TWO_SIDED|95.0|0.27|2.17|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, upper GI disorder, acid-suppressing drugs."|||2.17|0.27|0.6216
72540279|NCT01236053|144610127|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.35||||0.6893|TWO_SIDED|95.0|0.31|5.96|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag)."|||5.96|0.31|0.6893
72540280|NCT01236053|144610127|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.07||||0.9273|TWO_SIDED|95.0|0.24|4.84|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, upper GI disorder, acid-suppressing drugs."|||4.84|0.24|0.9273
72540281|NCT01236053|144610127|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.33||||0.598|TWO_SIDED|95.0|0.47|3.78|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag)."|||3.78|0.47|0.5980
72540282|NCT01236053|144610127|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.1||||0.8572|TWO_SIDED|95.0|0.38|3.18|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, upper GI disorder, acid-suppressing drugs."|||3.18|0.38|0.8572
72575378|NCT03185013|144676780|SUPERIORITY|Superiority was concluded if the lower bound of the 95% CI exceeded 0.|Difference in percentage|10.8|||||TWO_SIDED|95.0|-0.5|20.1||||||||20.1|-0.5|
72540283|NCT01236053|144610127|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.84||||0.7807|TWO_SIDED|95.0|0.26|2.77|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag)."|||2.77|0.26|0.7807
72540284|NCT01236053|144610127|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.7||||0.5579|TWO_SIDED|95.0|0.21|2.32|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, upper GI disorder, acid-suppressing drugs."|||2.32|0.21|0.5579
72540285|NCT01236053|144610127|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.0||||0.9932|TWO_SIDED|95.0|0.4|2.53|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag)."|||2.53|0.40|0.9932
72540286|NCT01236053|144610127|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.83||||0.6901|TWO_SIDED|95.0|0.32|2.11|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, upper GI disorder, acid-suppressing drugs."|||2.11|0.32|0.6901
72540287|NCT01236053|144610129|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.62||||0.431|TWO_SIDED|95.0|0.19|2.01|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag)."|||2.01|0.19|0.4310
72540288|NCT01236053|144610129|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.55||||0.3226|TWO_SIDED|95.0|0.17|1.79|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, upper GI disorder, acid-suppressing drugs."|||1.79|0.17|0.3226
72540289|NCT01236053|144610129|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.36||||0.6206|TWO_SIDED|95.0|0.4|4.59|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag)."|||4.59|0.40|0.6206
72540290|NCT01236053|144610129|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.12||||0.8557|TWO_SIDED|95.0|0.33|3.84|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, upper GI disorder, acid-suppressing drugs."|||3.84|0.33|0.8557
72540291|NCT01236053|144610129|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.91||||0.1498|TWO_SIDED|95.0|0.79|4.62|||Unadjusted Odds Ratio||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag)."|||4.62|0.79|0.1498
72540292|NCT01236053|144610129|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.66||||0.2645|TWO_SIDED|95.0|0.68|4.07|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, upper GI disorder, acid-suppressing drugs."|||4.07|0.68|0.2645
72540293|NCT01236053|144610129|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.66||||0.5728|TWO_SIDED|95.0|0.16|2.79|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag)."|||2.79|0.16|0.5728
72540294|NCT01236053|144610129|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.52||||0.3727|TWO_SIDED|95.0|0.12|2.21|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, upper GI disorder, acid-suppressing drugs."|||2.21|0.12|0.3727
72540295|NCT01236053|144610129|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.86||||0.7743|TWO_SIDED|95.0|0.31|2.4|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag)."|||2.40|0.31|0.7743
72540296|NCT01236053|144610129|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.69||||0.4775|TWO_SIDED|95.0|0.24|1.94|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, upper GI disorder, acid-suppressing drugs."|||1.94|0.24|0.4775
72540297|NCT01236053|144610130|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|7.33||||0.0032|TWO_SIDED|95.0|1.95|27.56|||Conditional Logistic Regression||"Comparison: Ever (with 2 year lag) and Never (with 2 year lag)."|||27.56|1.95|0.0032
72540298|NCT01236053|144610130|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.39||||0.1251|TWO_SIDED|95.0|0.71|16.17|||Conditional Logistic Regression||"Comparison: Ever (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, HIV, HPV (genital)."|||16.17|0.71|0.1251
72540299|NCT01236053|144610130|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.22||||0.0261|TWO_SIDED|95.0|1.15|9.01|||Conditional Logistic Regression||"Comparison: Ever (without 2 year lag) and Never (without 2 year lag)."|||9.01|1.15|0.0261
72540300|NCT01236053|144610130|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.16||||0.209|TWO_SIDED|95.0|0.65|7.17|||Conditional Logistic Regression||"Comparison: Ever (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, HIV, HPV (genital)."|||7.17|0.65|0.2090
72575379|NCT03185013|144676781|SUPERIORITY|Superiority was concluded if the lower bound of the 95% CI exceeded 0.|Location shift|224.0|||||TWO_SIDED|95.0|24.0|224.0||||||Week 15: HPV-16 E7||224.0|24.0|
72540301|NCT01236053|144610131|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|20.0||||0.0144|TWO_SIDED|95.0|1.81|220.5|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag)."|||220.5|1.81|0.0144
72540302|NCT01236053|144610131|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|21.47||||0.0158|TWO_SIDED|95.0|1.78|258.8|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, HIV, HPV (genital)."|||258.8|1.78|0.0158
72540303|NCT01236053|144610131|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.86||||0.0524|TWO_SIDED|95.0|0.99|15.14|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag)."|||15.14|0.99|0.0524
72540304|NCT01236053|144610131|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.21||||0.0269|TWO_SIDED|95.0|1.21|22.51|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, HIV, HPV (genital)."|||22.51|1.21|0.0269
72540305|NCT01236053|144610131|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.0||||0.1888|TWO_SIDED|95.0|0.45|55.14|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag)."|||55.14|0.45|0.1888
72627524|NCT02431325|144783882|SUPERIORITY|||||||0.84|||||||t-test, 2 sided|||||||0.84
72627525|NCT02431325|144783883|SUPERIORITY|||||||0.51|||||||t-test, 2 sided|||||||0.51
72627526|NCT02431325|144783884|SUPERIORITY|||||||0.93|||||||t-test, 2 sided|||||||0.93
72540306|NCT01236053|144610131|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.0||||0.999|TWO_SIDED|95.0|0.03|32.21|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, HIV, HPV (genital)."|||32.21|0.03|0.9990
72540307|NCT01236053|144610131|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.75||||0.2885|TWO_SIDED|95.0|0.33|43.08|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag)."|||43.08|0.33|0.2885
72540308|NCT01236053|144610131|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.93||||0.9608|TWO_SIDED|95.0|0.06|13.87|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, HIV, HPV (genital)."|||13.87|0.06|0.9608
72540309|NCT01236053|144610131|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.33||||0.0944|TWO_SIDED|95.0|0.78|24.07|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag)."|||24.07|0.78|0.0944
72540310|NCT01236053|144610131|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.9||||0.9253|TWO_SIDED|95.0|0.1|7.82|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, HIV, HPV (genital)."|||7.82|0.10|0.9253
72540311|NCT01236053|144610132|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|20.0||||0.0144|TWO_SIDED|95.0|1.81|220.5|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag)."|||220.5|1.81|0.0144
72540312|NCT01236053|144610132|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|21.47||||0.0158|TWO_SIDED|95.0|1.78|258.8|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, HIV, HPV (genital)."|||258.8|1.78|0.0158
72540313|NCT01236053|144610132|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.0||||0.0141|TWO_SIDED|95.0|1.43|25.11|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag)."|||25.11|1.43|0.0141
72540314|NCT01236053|144610132|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|8.56||||0.0063|TWO_SIDED|95.0|1.83|40.02|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, HIV, HPV (genital)."|||40.02|1.83|0.0063
72540315|NCT01236053|144610132|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.0||||0.1888|TWO_SIDED|95.0|0.45|55.14|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag)."|||55.14|0.45|0.1888
72540316|NCT01236053|144610132|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.0||||0.999|TWO_SIDED|95.0|0.03|32.21|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, HIV, HPV (genital)."|||32.21|0.03|0.9990
72540317|NCT01236053|144610132|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.75||||0.2885|TWO_SIDED|95.0|0.33|43.08|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag)."|||43.08|0.33|0.2885
72540318|NCT01236053|144610132|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.93||||0.9608|TWO_SIDED|95.0|0.06|13.87|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, HIV, HPV (genital)."|||13.87|0.06|0.9608
72540319|NCT01236053|144610132|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.33||||0.0944|TWO_SIDED|95.0|0.78|24.07|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag)."|||24.07|0.78|0.0944
72540320|NCT01236053|144610132|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.92||||0.9381||95.0|0.11|7.97|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, HIV, HPV (genital)."|||7.97|0.11|0.9381
72540321|NCT01236053|144610134|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|20.0||||0.0144|TWO_SIDED|95.0|1.81|220.5|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag)."|||220.5|1.81|0.0144
72540322|NCT01236053|144610134|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|21.55||||0.0157|TWO_SIDED|95.0|1.78|260.2|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, HIV, HPV (genital)."|||260.2|1.78|0.0157
72540323|NCT01236053|144610134|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.86||||0.0524|TWO_SIDED|95.0|0.99|15.14|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag)."|||15.14|0.99|0.0524
72540324|NCT01236053|144610134|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.8||||0.0333|TWO_SIDED|95.0|1.13|20.31|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, HIV, HPV (genital)."|||20.31|1.13|0.0333
72540325|NCT01236053|144610134|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.34||||0.2966|TWO_SIDED|95.0|0.35|32.06|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag)."|||32.06|0.35|0.2966
72540326|NCT01236053|144610134|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.62||||0.751|TWO_SIDED|95.0|0.03|12.31|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, HIV, HPV (genital)."|||12.31|0.03|0.7510
72540327|NCT01236053|144610134|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.71||||0.1868|TWO_SIDED|95.0|0.4|113.4|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag)."|||113.4|0.40|0.1868
72540328|NCT01236053|144610134|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.66||||0.7558|TWO_SIDED|95.0|0.07|40.61|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, HIV, HPV (genital)."|||40.61|0.07|0.7558
72540329|NCT01236053|144610134|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.33||||0.0944|TWO_SIDED|95.0|0.78|24.07|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag)."|||24.07|0.78|0.0944
72409800|NCT02033889|144328102|SUPERIORITY||Difference in Least Squares Means|-2.42||||0.001|TWO_SIDED|95.0|-3.86|-0.98|||Constrained Longitudinal Data Analysis||||Based on the cLDA model with fixed effects for treatment, time, prior antihyperglycemic medication (metformin monotherapy or metformin + another AHA), baseline eGFR (continuous), menopausal status, and the interaction of time by treatment. Time was treated as a categorical variable.|-0.98|-3.86|0.001
72540330|NCT01236053|144610134|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.9||||0.9244|TWO_SIDED|95.0|0.1|7.81|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, HIV, HPV (genital)."|||7.81|0.10|0.9244
72540331|NCT01236053|144610135|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.27||||0.0963|TWO_SIDED|95.0|0.96|1.7|||Conditional Logistic Regression||"Comparison: Ever (with 2 year lag) and Never (with 2 year lag)."|||1.70|0.96|0.0963
72540332|NCT01236053|144610135|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.94||||0.671|TWO_SIDED|95.0|0.69|1.27|||Conditional Logistic Regression||"Comparison: Ever (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, COPD."|||1.27|0.69|0.6710
72540333|NCT01236053|144610135|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.84|||<|0.0001|TWO_SIDED|95.0|1.54|2.2|||Conditional Logistic Regression||"Comparison: Ever (without 2 year lag) and Never (without 2 year lag)."|||2.20|1.54|<0.0001
72540334|NCT01236053|144610135|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.5|||<|0.0001|TWO_SIDED|95.0|1.24|1.81|||Conditional Logistic Regression||"Comparison: Ever (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, COPD."|||1.81|1.24|<0.0001
72540335|NCT01236053|144610136|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.41||||0.1184|TWO_SIDED|95.0|0.92|2.18|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag)."|||2.18|0.92|0.1184
72540336|NCT01236053|144610136|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.94||||0.8016|TWO_SIDED|95.0|0.59|1.5|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, COPD."|||1.50|0.59|0.8016
72540337|NCT01236053|144610136|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.27|||<|0.0001|TWO_SIDED|95.0|1.77|2.91|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag)."|||2.91|1.77|<0.0001
72540338|NCT01236053|144610136|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.97|||<|0.0001|TWO_SIDED|95.0|1.51|2.58|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, COPD."|||2.58|1.51|<0.0001
72540339|NCT01236053|144610136|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.16||||0.6105|TWO_SIDED|95.0|0.65|2.08|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag)."|||2.08|0.65|0.6105
72540340|NCT01236053|144610136|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.14||||0.6797|TWO_SIDED|95.0|0.62|2.09|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, COPD."|||2.09|0.62|0.6797
72540341|NCT01236053|144610136|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.64||||0.0103|TWO_SIDED|95.0|1.12|2.39|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag)."|||2.39|1.12|0.0103
72540342|NCT01236053|144610136|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.34||||0.1629|TWO_SIDED|95.0|0.89|2.0|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, COPD."|||2.00|0.89|0.1629
72540343|NCT01236053|144610136|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.2||||0.4713|TWO_SIDED|95.0|0.73|1.97|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag)."|||1.97|0.73|0.4713
72540344|NCT01236053|144610136|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.82||||0.4505|TWO_SIDED|95.0|0.49|1.38|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, COPD."|||1.38|0.49|0.4505
72540345|NCT01236053|144610136|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.45||||0.0284|TWO_SIDED|95.0|1.04|2.01|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag)."|||2.01|1.04|0.0284
72540346|NCT01236053|144610136|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.09||||0.6262|TWO_SIDED|95.0|0.77|1.54|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, COPD."|||1.54|0.77|0.6262
72540347|NCT01236053|144610137|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.52||||0.0798|TWO_SIDED|95.0|0.95|2.41|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag)."|||2.41|0.95|0.0798
72540348|NCT01236053|144610137|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.05||||0.8357|TWO_SIDED|95.0|0.64|1.73|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, COPD."|||1.73|0.64|0.8357
72540349|NCT01236053|144610137|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.29|||<|0.0001|TWO_SIDED|95.0|1.75|3.01|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag)."|||3.01|1.75|<0.0001
72540350|NCT01236053|144610137|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.05|||<|0.0001|TWO_SIDED|95.0|1.53|2.76|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, COPD."|||2.76|1.53|<0.0001
72540351|NCT01236053|144610137|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.08||||0.7794|TWO_SIDED|95.0|0.63|1.85|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag)."|||1.85|0.63|0.7794
72540352|NCT01236053|144610137|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.93||||0.8075|TWO_SIDED|95.0|0.52|1.66|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, COPD."|||1.66|0.52|0.8075
72627527|NCT02431325|144783885|SUPERIORITY|||||||0.09|||||||Wilcoxon (Mann-Whitney)|||Change from baseline at week 24||||0.09
72540353|NCT01236053|144610137|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.84||||0.0001|TWO_SIDED|95.0|1.35|2.52|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag)."|||2.52|1.35|0.0001
72540354|NCT01236053|144610137|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.51||||0.0161|TWO_SIDED|95.0|1.08|2.12|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, COPD."|||2.12|1.08|0.0161
72540355|NCT01236053|144610137|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.23||||0.3972|TWO_SIDED|95.0|0.76|2.0|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag)."|||2.00|0.76|0.3972
72540356|NCT01236053|144610137|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.84||||0.495|TWO_SIDED|95.0|0.5|1.39|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, COPD."|||1.39|0.50|0.4950
72540357|NCT01236053|144610137|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.38||||0.0601|TWO_SIDED|95.0|0.99|1.94|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag)."|||1.94|0.99|0.0601
72540358|NCT01236053|144610137|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.02||||0.9286|TWO_SIDED|95.0|0.71|1.45|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, COPD."|||1.45|0.71|0.9286
72540359|NCT01236053|144610138|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.23||||0.5394|TWO_SIDED|95.0|0.63|2.39|||Conditional Logistic Regression||"Comparison: \> 1 year (with 2 year lag) and Never (with 2 year lag)."|||2.39|0.63|0.5394
72540360|NCT01236053|144610138|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.79||||0.507|TWO_SIDED|95.0|0.39|1.58|||Conditional Logistic Regression||"Comparison: \> 1 year (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, COPD."|||1.58|0.39|0.5070
72540361|NCT01236053|144610138|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.15||||0.5426|TWO_SIDED|95.0|0.73|1.83|||Conditional Logistic Regression||"Comparison: \> 1 year (without 2 year lag) and Never (without 2 year lag)."|||1.83|0.73|0.5426
72540362|NCT01236053|144610138|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.85||||0.515|TWO_SIDED|95.0|0.52|1.38|||Conditional Logistic Regression||"Comparison: \> 1 year (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, COPD."|||1.38|0.52|0.5150
72540363|NCT01236053|144610138|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.53||||0.435|TWO_SIDED|95.0|0.53|4.42|||Conditional Logistic Regression||"Comparison: \> 2 years (with 2 year lag) and Never (with 2 year lag)."|||4.42|0.53|0.4350
72627528|NCT02431325|144783885|SUPERIORITY|||||||0.25|||||||Wilcoxon (Mann-Whitney)|||Change from baseline at week 12||||0.25
72540364|NCT01236053|144610138|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.13||||0.8276|TWO_SIDED|95.0|0.37|3.43|||Conditional Logistic Regression||"Comparison: \> 2 years (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, COPD."|||3.43|0.37|0.8276
72540365|NCT01236053|144610138|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.32||||0.4022|TWO_SIDED|95.0|0.69|2.5|||Conditional Logistic Regression||"Comparison: \> 2 years (without 2 year lag) and Never (without 2 year lag)."|||2.50|0.69|0.4022
72540366|NCT01236053|144610138|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.94||||0.8681|TWO_SIDED|95.0|0.48|1.86|||Conditional Logistic Regression||"Comparison: \> 2 years (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, COPD."|||1.86|0.48|0.8681
72540367|NCT01236053|144610138|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.67||||0.6326|TWO_SIDED|95.0|0.2|13.86|||Conditional Logistic Regression||"Comparison: \> 3 years (with 2 year lag) and Never (with 2 year lag)."|||13.86|0.20|0.6326
72540368|NCT01236053|144610138|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.87||||0.577|TWO_SIDED|95.0|0.21|16.86|||Conditional Logistic Regression||"Comparison: \> 3 years (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, COPD."|||16.86|0.21|0.5770
72540369|NCT01236053|144610138|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.14||||0.8087|TWO_SIDED|95.0|0.4|3.21|||Conditional Logistic Regression||"Comparison: \> 3 years (without 2 year lag) and Never (without 2 year lag)."|||3.21|0.40|0.8087
72540370|NCT01236053|144610138|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.9||||0.8497|TWO_SIDED|95.0|0.31|2.64|||Conditional Logistic Regression||"Comparison: \> 3 years (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, COPD."|||2.64|0.31|0.8497
72540371|NCT01236053|144610139|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.4||||0.1528|TWO_SIDED|95.0|0.88|2.24|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag)."|||2.24|0.88|0.1528
72540372|NCT01236053|144610139|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.01||||0.9625|TWO_SIDED|95.0|0.62|1.65|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, COPD."|||1.65|0.62|0.9625
72540373|NCT01236053|144610139|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.96|||<|0.0001|TWO_SIDED|95.0|1.48|2.59|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag)."|||2.59|1.48|<0.0001
72540374|NCT01236053|144610139|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.7||||0.0006|TWO_SIDED|95.0|1.25|2.29|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, COPD."|||2.29|1.25|0.0006
72540375|NCT01236053|144610139|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.28||||0.3515|TWO_SIDED|95.0|0.76|2.16|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag)."|||2.16|0.76|0.3515
72627529|NCT02431325|144783886|SUPERIORITY|||||||0.51|||||||t-test, 2 sided|||||||0.51
72627530|NCT02431325|144783887|SUPERIORITY|||||||0.07|||||||t-test, 2 sided|||||||0.07
72540376|NCT01236053|144610139|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.03||||0.9069|TWO_SIDED|95.0|0.59|1.82|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, COPD."|||1.82|0.59|0.9069
72540377|NCT01236053|144610139|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.39|||<|0.0001|TWO_SIDED|95.0|1.78|3.21|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag)."|||3.21|1.78|<0.0001
72540378|NCT01236053|144610139|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.04|||<|0.0001|TWO_SIDED|95.0|1.48|2.81|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, COPD."|||2.81|1.48|<0.0001
72540379|NCT01236053|144610139|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.14||||0.5948|TWO_SIDED|95.0|0.7|1.88|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag)."|||1.88|0.70|0.5948
72540380|NCT01236053|144610139|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.8||||0.3984|TWO_SIDED|95.0|0.47|1.35|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, COPD."|||1.35|0.47|0.3984
72540381|NCT01236053|144610139|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.26||||0.1872|TWO_SIDED|95.0|0.89|1.79|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag)."|||1.79|0.89|0.1872
72540382|NCT01236053|144610139|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.93||||0.6772|TWO_SIDED|95.0|0.64|1.34|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, COPD."|||1.34|0.64|0.6772
72540383|NCT01236053|144610140|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.49||||0.4933|TWO_SIDED|95.0|0.07|3.72|||Conditional Logistic Regression||"Comparison: Ever (without 2 year lag) and Never (without 2 year lag)."|||3.72|0.07|0.4933
72540384|NCT01236053|144610140|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.43||||0.4147|TWO_SIDED|95.0|0.06|3.27|||Conditional Logistic Regression||"Comparison: Ever (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy."|||3.27|0.06|0.4147
72540385|NCT01236053|144610141|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.27||||0.8257|TWO_SIDED|95.0|0.15|10.38|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag)."|||10.38|0.15|0.8257
72540386|NCT01236053|144610141|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.08||||0.9467|TWO_SIDED|95.0|0.13|9.02|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy."|||9.02|0.13|0.9467
72540387|NCT01236053|144610141|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.0||||0.9859|TWO_SIDED|95.0|0.0|0.0|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag)."|||0.00|0.00|0.9859
72540388|NCT01236053|144610141|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.0||||0.9857|TWO_SIDED|95.0|0.0|0.0|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy."|||0.00|0.00|0.9857
72540389|NCT01236053|144610141|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.0||||0.986|TWO_SIDED|95.0|0.0|0.0|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag)."|||0.00|0.00|0.9860
72540390|NCT01236053|144610141|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.0||||0.9858|TWO_SIDED|95.0|0.0|0.0|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy."|||0.00|0.00|0.9858
72575380|NCT03185013|144676781|SUPERIORITY|Superiority was concluded if the lower bound of the 95% CI exceeded 0.|Location shift|0.0|||||TWO_SIDED|95.0|0.0|0.0||||||Week 36: HPV-16 E7||0.0|0.0|
72540391|NCT01236053|144610141|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.0||||0.9798|TWO_SIDED|95.0|0.0|0.0|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag)."|||0.00|0.00|0.9798
72540392|NCT01236053|144610141|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.0||||0.9796|TWO_SIDED|95.0|0.0|0.0|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy."|||0.00|0.00|0.9796
72575381|NCT03185013|144676781|SUPERIORITY|Superiority was concluded if the lower bound of the 95% CI exceeded 0.|Location Shift|2024.0|||||TWO_SIDED|95.0|2000.0|6050.0||||||Week 15: HPV-18 E7||6050.0|2000.0|
72540393|NCT01236053|144610142|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.71||||0.6252|TWO_SIDED|95.0|0.2|14.84|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag)."|||14.84|0.20|0.6252
72540394|NCT01236053|144610142|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.49||||0.7208|TWO_SIDED|95.0|0.17|13.28|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy."|||13.28|0.17|0.7208
72540395|NCT01236053|144610144|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.12||||0.9141|TWO_SIDED|95.0|0.14|9.03|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag)."|||9.03|0.14|0.9141
72540396|NCT01236053|144610144|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.95||||0.9613|TWO_SIDED|95.0|0.12|7.78|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy."|||7.78|0.12|0.9613
72540397|NCT01236053|144610145|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.27||||0.0323|TWO_SIDED|95.0|1.02|1.57|||Conditional Logistic Regression||"Comparison: Ever (with 2 year lag) and Never (with 2 year lag)."|||1.57|1.02|0.0323
72575382|NCT03185013|144676781|SUPERIORITY|Superiority was concluded if the lower bound of the 95% CI exceeded 0.|Location Shift|224.0|||||TWO_SIDED|95.0|74.0|674.0||||||Week 36: HPV-18 E7||674.0|74.0|
72575383|NCT03185013|144676782|SUPERIORITY|Superiority was concluded if the lower bound of the 95% CI exceeded 0.|Location shift|11.67|||||TWO_SIDED|95.0|8.33|20.0||||||HPV-16 E6: Week 15||20.00|8.33|
72575384|NCT03185013|144676782|SUPERIORITY|Superiority was concluded if the lower bound of the 95% CI exceeded 0.|Difference in median|8.33|||||TWO_SIDED|95.0|3.33|11.67||||||HPV-16 E6: Week 36||11.67|3.33|
72409801|NCT02033889|144328102|SUPERIORITY||Difference in Least Squares Means|-1.82||||0.013|TWO_SIDED|95.0|-3.24|-0.39|||Constrained Longitudinal Data Analysis||||Based on the cLDA model with fixed effects for treatment, time, prior antihyperglycemic medication (metformin monotherapy or metformin + another AHA), baseline eGFR (continuous), menopausal status, and the interaction of time by treatment. Time was treated as a categorical variable.|-0.39|-3.24|0.013
72540398|NCT01236053|144610145|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.22||||0.0682|TWO_SIDED|95.0|0.99|1.52|||Conditional Logistic Regression||"Comparison: Ever (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, hysterectomy, current estrogen, prior estrogen, benign breast disease."|||1.52|0.99|0.0682
72540399|NCT01236053|144610145|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.19||||0.0326|TWO_SIDED|95.0|1.01|1.4|||Conditional Logistic Regression||"Comparison: Ever (without 2 year lag) and Never (without 2 year lag)."|||1.40|1.01|0.0326
72540400|NCT01236053|144610145|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.16||||0.0699|TWO_SIDED|95.0|0.99|1.36|||Conditional Logistic Regression||"Comparison: Ever (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, hysterectomy, current estrogen, prior estrogen, benign breast disease."|||1.36|0.99|0.0699
72540401|NCT01236053|144610146|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.2||||0.2893|TWO_SIDED|95.0|0.86|1.69|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag)."|||1.69|0.86|0.2893
72540402|NCT01236053|144610146|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.15||||0.4301|TWO_SIDED|95.0|0.82|1.61|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, hysterectomy, current estrogen, prior estrogen, benign breast disease."|||1.61|0.82|0.4301
72540403|NCT01236053|144610146|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.24||||0.0806|TWO_SIDED|95.0|0.97|1.58|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag)."|||1.58|0.97|0.0806
72540404|NCT01236053|144610146|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.21||||0.1226|TWO_SIDED|95.0|0.95|1.55|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, hysterectomy, current estrogen, prior estrogen, benign breast disease."|||1.55|0.95|0.1226
72540405|NCT01236053|144610146|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.23||||0.3502|TWO_SIDED|95.0|0.8|1.89|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag)."|||1.89|0.80|0.3502
72540406|NCT01236053|144610146|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.17||||0.4654|TWO_SIDED|95.0|0.76|1.81|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, hysterectomy, current estrogen, prior estrogen, benign breast disease."|||1.81|0.76|0.4654
72540407|NCT01236053|144610146|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.86||||0.3987|TWO_SIDED|95.0|0.59|1.23|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag)."|||1.23|0.59|0.3987
72540408|NCT01236053|144610146|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.84||||0.3349|TWO_SIDED|95.0|0.58|1.2|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, hysterectomy, current estrogen, prior estrogen, benign breast disease."|||1.20|0.58|0.3349
72540409|NCT01236053|144610146|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.38||||0.0827|TWO_SIDED|95.0|0.96|1.98|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag)."|||1.98|0.96|0.0827
72540410|NCT01236053|144610146|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.36||||0.0932|TWO_SIDED|95.0|0.95|1.96|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, hysterectomy, current estrogen, prior estrogen, benign breast disease."|||1.96|0.95|0.0932
72540411|NCT01236053|144610146|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.39||||0.013|TWO_SIDED|95.0|1.07|1.8|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag)."|||1.80|1.07|0.0130
72540412|NCT01236053|144610146|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.35||||0.0241|TWO_SIDED|95.0|1.04|1.75|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, hysterectomy, current estrogen, prior estrogen, benign breast disease."|||1.75|1.04|0.0241
72540413|NCT01236053|144610147|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.14||||0.5043|TWO_SIDED|95.0|0.77|1.68|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag)."|||1.68|0.77|0.5043
72540414|NCT01236053|144610147|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.08||||0.7129|TWO_SIDED|95.0|0.73|1.59|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, hysterectomy, current estrogen, prior estrogen, benign breast disease."|||1.59|0.73|0.7129
72540415|NCT01236053|144610147|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.19||||0.2055|TWO_SIDED|95.0|0.91|1.57|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag)."|||1.57|0.91|0.2055
72540416|NCT01236053|144610147|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.16||||0.3005|TWO_SIDED|95.0|0.88|1.52|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, hysterectomy, current estrogen, prior estrogen, benign breast disease."|||1.52|0.88|0.3005
72540417|NCT01236053|144610147|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.22||||0.2849|TWO_SIDED|95.0|0.84|1.77|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag)."|||1.77|0.84|0.2849
72575385|NCT03185013|144676782|SUPERIORITY|Superiority was concluded if the lower bound of the 95% CI exceeded 0.|Difference in median|10.83|||||TWO_SIDED|95.0|5.0|15.0||||||HPV-16 E7: Week 15||15.00|5.00|
72409802|NCT02033889|144328103|SUPERIORITY||Adjusted Odds Ratio|5.41|||<|0.001|TWO_SIDED|95.0|2.1|13.9|||Regression, Logistic||||Adjusted odds ratio based on a logistic regression model fitted with fixed effects for treatment, prior antihyperglycemic medication (metformin monotherapy or metformin + another AHA), menopausal status, covariates for baseline A1C and baseline eGFR (continuous). Missing data imputed using a multiple imputation procedure based on cLDA prediction modeling with fixed effects as in the primary analysis, which allows for participants with missing data to be included in the analysis.|13.90|2.10|<0.001
72540418|NCT01236053|144610147|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.19||||0.365|TWO_SIDED|95.0|0.82|1.72|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, hysterectomy, current estrogen, prior estrogen, benign breast disease."|||1.72|0.82|0.3650
72540419|NCT01236053|144610147|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.05||||0.7559|TWO_SIDED|95.0|0.78|1.4|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag)."|||1.40|0.78|0.7559
72540420|NCT01236053|144610147|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.03||||0.852|TWO_SIDED|95.0|0.77|1.37|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, hysterectomy, current estrogen, prior estrogen, benign breast disease."|||1.37|0.77|0.8520
72540421|NCT01236053|144610147|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.44||||0.0459|TWO_SIDED|95.0|1.01|2.06|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag)."|||2.06|1.01|0.0459
72540422|NCT01236053|144610147|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.42||||0.0542|TWO_SIDED|95.0|0.99|2.04|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, hysterectomy, current estrogen, prior estrogen, benign breast disease."|||2.04|0.99|0.0542
72540423|NCT01236053|144610147|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.34||||0.0312|TWO_SIDED|95.0|1.03|1.74|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag)."|||1.74|1.03|0.0312
72540424|NCT01236053|144610147|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.3||||0.0508|TWO_SIDED|95.0|1.0|1.7|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, hysterectomy, current estrogen, prior estrogen, benign breast disease."|||1.70|1.00|0.0508
72540425|NCT01236053|144610148|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.51||||0.0892|TWO_SIDED|95.0|0.94|2.42|||Conditional Logistic Regression||"Comparison: \> 1 year (with 2 year lag) and Never (with 2 year lag)."|||2.42|0.94|0.0892
72540426|NCT01236053|144610148|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.48||||0.1043|TWO_SIDED|95.0|0.92|2.39|||Conditional Logistic Regression||"Comparison: \> 1 year (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, hysterectomy, current estrogen, prior estrogen, benign breast disease."|||2.39|0.92|0.1043
72540427|NCT01236053|144610148|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.51||||0.0101|TWO_SIDED|95.0|1.1|2.06|||Conditional Logistic Regression||"Comparison: \> 1 year (without 2 year lag) and Never (without 2 year lag)."|||2.06|1.10|0.0101
72540428|NCT01236053|144610148|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.46||||0.0186|TWO_SIDED|95.0|1.07|2.0|||Conditional Logistic Regression||"Comparison: \> 1 year (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, hysterectomy, current estrogen, prior estrogen, benign breast disease."|||2.00|1.07|0.0186
72540429|NCT01236053|144610148|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.69||||0.1458|TWO_SIDED|95.0|0.83|3.43|||Conditional Logistic Regression||"Comparison: \> 2 years (with 2 year lag) and Never (with 2 year lag)."|||3.43|0.83|0.1458
72540430|NCT01236053|144610148|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.62||||0.1859|TWO_SIDED|95.0|0.79|3.29|||Conditional Logistic Regression||"Comparison: \> 2 years (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, hysterectomy, current estrogen, prior estrogen, benign breast disease."|||3.29|0.79|0.1859
72540431|NCT01236053|144610148|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.75||||0.0122|TWO_SIDED|95.0|1.13|2.72|||Conditional Logistic Regression||"Comparison: \> 2 years (without 2 year lag) and Never (without 2 year lag)."|||2.72|1.13|0.0122
72540432|NCT01236053|144610148|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.72||||0.0162|TWO_SIDED|95.0|1.1|2.67|||Conditional Logistic Regression||"Comparison: \> 2 years (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, hysterectomy, current estrogen, prior estrogen, benign breast disease."|||2.67|1.10|0.0162
72540433|NCT01236053|144610148|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.8||||0.7573|TWO_SIDED|95.0|0.19|3.36|||Conditional Logistic Regression||"Comparison: \> 3 years (with 2 year lag) and Never (with 2 year lag)."|||3.36|0.19|0.7573
72540434|NCT01236053|144610148|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.76||||0.7088|TWO_SIDED|95.0|0.18|3.21|||Conditional Logistic Regression||"Comparison: \> 3 years (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, hysterectomy, current estrogen, prior estrogen, benign breast disease."|||3.21|0.18|0.7088
72540435|NCT01236053|144610148|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.84||||0.0787|TWO_SIDED|95.0|0.93|3.64|||Conditional Logistic Regression||"Comparison: \> 3 years (without 2 year lag) and Never (without 2 year lag)."|||3.64|0.93|0.0787
72540436|NCT01236053|144610148|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.81||||0.0873|TWO_SIDED|95.0|0.92|3.58|||Conditional Logistic Regression||"Comparison: \> 3 years (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, hysterectomy, current estrogen, prior estrogen, benign breast disease."|||3.58|0.92|0.0873
72540437|NCT01236053|144610149|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.17||||0.4233|TWO_SIDED|95.0|0.8|1.7|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag)."|||1.70|0.80|0.4233
72540438|NCT01236053|144610149|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.11||||0.5908|TWO_SIDED|95.0|0.76|1.62|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, hysterectomy, current estrogen, prior estrogen, benign breast disease."|||1.62|0.76|0.5908
72540439|NCT01236053|144610149|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.29||||0.054|TWO_SIDED|95.0|1.0|1.67|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag)."|||1.67|1.00|0.0540
72540440|NCT01236053|144610149|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.25||||0.0939|TWO_SIDED|95.0|0.96|1.62|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, hysterectomy, current estrogen, prior estrogen, benign breast disease."|||1.62|0.96|0.0939
72540441|NCT01236053|144610149|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.27||||0.214|TWO_SIDED|95.0|0.87|1.87|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag)."|||1.87|0.87|0.2140
72540442|NCT01236053|144610149|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.23||||0.294|TWO_SIDED|95.0|0.84|1.8|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, hysterectomy, current estrogen, prior estrogen, benign breast disease."|||1.80|0.84|0.2940
72540443|NCT01236053|144610149|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.97||||0.8352|TWO_SIDED|95.0|0.71|1.32|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag)."|||1.32|0.71|0.8352
72540444|NCT01236053|144610149|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.96||||0.7809|TWO_SIDED|95.0|0.7|1.31|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, hysterectomy, current estrogen, prior estrogen, benign breast disease."|||1.31|0.70|0.7809
72540445|NCT01236053|144610149|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.36||||0.0921|TWO_SIDED|95.0|0.95|1.94|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag)."|||1.94|0.95|0.0921
72540446|NCT01236053|144610149|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.34||||0.1091|TWO_SIDED|95.0|0.94|1.92|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, hysterectomy, current estrogen, prior estrogen, benign breast disease."|||1.92|0.94|0.1091
72540447|NCT01236053|144610149|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.29||||0.0564|TWO_SIDED|95.0|0.99|1.68|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag)."|||1.68|0.99|0.0564
72540448|NCT01236053|144610149|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.25||||0.0939|TWO_SIDED|95.0|0.96|1.63|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, hysterectomy, current estrogen, prior estrogen, benign breast disease."|||1.63|0.96|0.0939
72540449|NCT01236053|144610150|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.58||||0.3082|TWO_SIDED|95.0|0.31|41.71|||Conditional Logistic Regression||"Comparison: Ever (with 2 year lag) and Never (with 2 year lag)."|||41.71|0.31|0.3082
72540450|NCT01236053|144610150|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.9||||0.3999|TWO_SIDED|95.0|0.24|34.69|||Conditional Logistic Regression||"Comparison: Ever (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, HIV, HPV (genital), phimosis/balanitis."|||34.69|0.24|0.3999
72540451|NCT01236053|144610150|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.42||||0.7509|TWO_SIDED|95.0|0.16|12.52|||Conditional Logistic Regression||"Comparison: Ever (without 2 year lag) and Never (without 2 year lag)."|||12.52|0.16|0.7509
72540452|NCT01236053|144610150|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.75||||0.6303|TWO_SIDED|95.0|0.18|17.07|||Conditional Logistic Regression||"Comparison: Ever (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, HIV, HPV (genital), phimosis/balanitis."|||17.07|0.18|0.6303
72540453|NCT01236053|144610151|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.32||||0.2038|TWO_SIDED|95.0|0.37|108.8|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag)."|||108.8|0.37|0.2038
72540454|NCT01236053|144610151|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.63||||0.2866|TWO_SIDED|95.0|0.28|77.51|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, HIV, HPV (genital), phimosis/balanitis."|||77.51|0.28|0.2866
72540455|NCT01236053|144610151|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.32||||0.2038|TWO_SIDED|95.0|0.37|108.8|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag)."|||108.8|0.37|0.2038
72540456|NCT01236053|144610151|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|20.4||||0.1118|TWO_SIDED|95.0|0.5|839.0|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, HIV, HPV (genital), phimosis/balanitis."|||839.0|0.50|0.1118
72540457|NCT01236053|144610152|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.32||||0.2038|TWO_SIDED|95.0|0.37|108.8|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag)."|||108.8|0.37|0.2038
72540458|NCT01236053|144610152|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.63||||0.2866|TWO_SIDED|95.0|0.28|77.51|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, HIV, HPV (genital), phimosis/balanitis."|||77.51|0.28|0.2866
72540459|NCT01236053|144610152|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.32||||0.2038|TWO_SIDED|95.0|0.37|108.8|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag)."|||108.8|0.37|0.2038
72575386|NCT03185013|144676782|SUPERIORITY|Superiority was concluded if the lower bound of the 95% CI exceeded 0.|Difference in median|7.5|||||TWO_SIDED|95.0|1.67|10.0||||||HPV-16 E7: Week 36||10.00|1.67|
72540460|NCT01236053|144610152|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|20.4||||0.1118|TWO_SIDED|95.0|0.5|839.0|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, HIV, HPV (genital), phimosis/balanitis."|||839.0|0.50|0.1118
72540461|NCT01236053|144610154|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.32||||0.2038|TWO_SIDED|95.0|0.37|108.8|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag)."|||108.8|0.37|0.2038
72540462|NCT01236053|144610154|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.63||||0.2866|TWO_SIDED|95.0|0.28|77.51|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, HIV, HPV (genital), phimosis/balanitis."|||77.51|0.28|0.2866
72540463|NCT01236053|144610154|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.32||||0.2038|TWO_SIDED|95.0|0.37|108.8|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag)."|||108.8|0.37|0.2038
72540464|NCT01236053|144610154|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|20.4||||0.1118|TWO_SIDED|95.0|0.5|839.0|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, HIV, HPV (genital), phimosis/balanitis."|||839.0|0.5|0.1118
72540465|NCT01236053|144610155|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.99||||0.9614|TWO_SIDED|95.0|0.58|1.69|||Conditional Logistic Regression||"Comparison: Ever (with 2 year lag) and Never (with 2 year lag)."|||1.69|0.58|0.9614
72540466|NCT01236053|144610155|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.84||||0.5179|TWO_SIDED|95.0|0.49|1.44|||Conditional Logistic Regression||"Comparison: Ever (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy."|||1.44|0.49|0.5179
72540467|NCT01236053|144610155|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.03||||0.8856|TWO_SIDED|95.0|0.71|1.48|||Conditional Logistic Regression||"Comparison: Ever (without 2 year lag) and Never (without 2 year lag)."|||1.48|0.71|0.8856
72540468|NCT01236053|144610155|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.88||||0.5078|TWO_SIDED|95.0|0.61|1.28|||Conditional Logistic Regression||"Comparison: Ever (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy."|||1.28|0.61|0.5078
72540469|NCT01236053|144610156|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.84||||0.6888|TWO_SIDED|95.0|0.36|1.95|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag)."|||1.95|0.36|0.6888
72540470|NCT01236053|144610156|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.75||||0.5024|TWO_SIDED|95.0|0.32|1.75|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy."|||1.75|0.32|0.5024
72540471|NCT01236053|144610156|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.86||||0.6164|TWO_SIDED|95.0|0.49|1.53|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag)."|||1.53|0.49|0.6164
72540472|NCT01236053|144610156|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.78||||0.4002|TWO_SIDED|95.0|0.44|1.39|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy."|||1.39|0.44|0.4002
72540473|NCT01236053|144610156|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.81||||0.7329|TWO_SIDED|95.0|0.25|2.66|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag)."|||2.66|0.25|0.7329
72627531|NCT00565409|144783927|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.36|||<|0.0001|TWO_SIDED|95.0|3.2|9.0||P-value from Cochran-Mantel-Haenszel(CMH) test of general association, testing treatment effect on response. P-value and Odds Ratio (OR) stratified by geographic region.|Cochran-Mantel-Haenszel|Loss of efficacy (LOE) imputation defined as LOE drop-outs were treated as non-responders/all other participants had LOCF applied as primary analysis.||Sample size estimated based on moderate/severe rheumatoid arthritis(RA) trial. Study design included only moderate RA participants, thus a low disease activity estimate of 85% (ETN+MTX) vs 70% (MTX only) assumed, required 175 randomized participants in 3 treatments for a 90% power and Type I error of 0.05 to reject the null hypothesis of no ETN+MTX vs MTX only differences. More participants qualified for Period 2 than expected, Period 2 sample size roughly 15% larger than protocol-specified.||9.0|3.2|<0.0001
72540474|NCT01236053|144610156|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.71||||0.5731|TWO_SIDED|95.0|0.22|2.33|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy."|||2.33|0.22|0.5731
72540475|NCT01236053|144610156|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.35||||0.3762|TWO_SIDED|95.0|0.69|2.63|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag)."|||2.63|0.69|0.3762
72627532|NCT00565409|144783927|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.15||||0.3805|TWO_SIDED|95.0|0.7|2.0||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|LOE imputation defined as LOE drop-outs were treated as non-responders and all other participants had LOCF applied as primary analysis.||||2.0|0.7|0.3805
72627533|NCT00565409|144783927|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.81|||<|0.0001|TWO_SIDED|95.0|3.0|7.6||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|LOE imputation defined as LOE drop-outs were treated as non-responders and all other participants had LOCF applied as primary analysis.||||7.6|3.0|<0.0001
72627534|NCT00565409|144783929|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.11||||0.0853|TWO_SIDED|95.0|0.5|21.4||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 36 Low Disease Activity||21.4|0.5|0.0853
72627535|NCT00565409|144783929|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.96||||0.8491|TWO_SIDED|95.0|0.2|4.8||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 36 Low Disease Activity||4.8|0.2|0.8491
72540476|NCT01236053|144610156|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.21||||0.582|TWO_SIDED|95.0|0.62|2.36|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy."|||2.36|0.62|0.5820
72540477|NCT01236053|144610156|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.37||||0.4782|TWO_SIDED|95.0|0.58|3.23|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag)."|||3.23|0.58|0.4782
72540478|NCT01236053|144610156|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.06||||0.8998|TWO_SIDED|95.0|0.44|2.52|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy."|||2.52|0.44|0.8998
72540479|NCT01236053|144610156|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.03||||0.9308|TWO_SIDED|95.0|0.53|1.99|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag)."|||1.99|0.53|0.9308
72540480|NCT01236053|144610156|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.8||||0.5125|TWO_SIDED|95.0|0.41|1.56|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy."|||1.56|0.41|0.5125
72540481|NCT01236053|144610157|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.92||||0.8655|TWO_SIDED|95.0|0.37|2.33|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag)."|||2.33|0.37|0.8655
72540482|NCT01236053|144610157|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.8||||0.6482|TWO_SIDED|95.0|0.32|2.05|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy."|||2.05|0.32|0.6482
72540483|NCT01236053|144610157|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.96||||0.9003|TWO_SIDED|95.0|0.53|1.76|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag)."|||1.76|0.53|0.9003
72540484|NCT01236053|144610157|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.85||||0.6|TWO_SIDED|95.0|0.46|1.56|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy."|||1.56|0.46|0.6000
72540485|NCT01236053|144610157|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.74||||0.567|TWO_SIDED|95.0|0.27|2.06|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag)."|||2.06|0.27|0.5670
72540486|NCT01236053|144610157|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.67||||0.4353|TWO_SIDED|95.0|0.24|1.85|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy."|||1.85|0.24|0.4353
72540487|NCT01236053|144610157|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.04||||0.8922|TWO_SIDED|95.0|0.56|1.95|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag)."|||1.95|0.56|0.8922
72540488|NCT01236053|144610157|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.94||||0.8591|TWO_SIDED|95.0|0.5|1.77|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy."|||1.77|0.50|0.8591
72540489|NCT01236053|144610157|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.37||||0.4779|TWO_SIDED|95.0|0.58|3.23|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag)."|||3.23|0.58|0.4779
72540490|NCT01236053|144610157|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.06||||0.8994|TWO_SIDED|95.0|0.44|2.52|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy."|||2.52|0.44|0.8994
72540491|NCT01236053|144610157|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.1||||0.78|TWO_SIDED|95.0|0.57|2.12|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag)."|||2.12|0.57|0.7800
72540492|NCT01236053|144610157|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.86||||0.6577|TWO_SIDED|95.0|0.44|1.67|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy."|||1.67|0.44|0.6577
72540493|NCT01236053|144610159|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.11||||0.8111|TWO_SIDED|95.0|0.48|2.59|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag)."|||2.59|0.48|0.8111
72540494|NCT01236053|144610159|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.05||||0.9104|TWO_SIDED|95.0|0.45|2.46|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy."|||2.46|0.45|0.9104
72540495|NCT01236053|144610159|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.18||||0.5592|TWO_SIDED|95.0|0.68|2.07|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag)."|||2.07|0.68|0.5592
72540496|NCT01236053|144610159|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.06||||0.8521|TWO_SIDED|95.0|0.6|1.85|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy."|||1.85|0.60|0.8521
72540497|NCT01236053|144610159|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.73||||0.5529|TWO_SIDED|95.0|0.26|2.04|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag)."|||2.04|0.26|0.5529
72540498|NCT01236053|144610159|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|0.6||||0.3275|TWO_SIDED|95.0|0.21|1.68|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy."|||1.68|0.21|0.3275
72540499|NCT01236053|144610159|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.89||||0.73|TWO_SIDED|95.0|0.46|1.72|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag)."|||1.72|0.46|0.7300
72540500|NCT01236053|144610159|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.79||||0.4831|TWO_SIDED|95.0|0.41|1.53|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy."|||1.53|0.41|0.4831
72409803|NCT02033889|144328103|SUPERIORITY||Adjusted Odds Ratio|3.1||||0.023|TWO_SIDED|95.0|1.17|8.22|||Regression, Logistic||||Adjusted odds ratio based on a logistic regression model fitted with fixed effects for treatment, prior antihyperglycemic medication (metformin monotherapy or metformin + another AHA), menopausal status, covariates for baseline A1C and baseline eGFR (continuous). Missing data imputed using a multiple imputation procedure based on cLDA prediction modeling with fixed effects as in the primary analysis, which allows for participants with missing data to be included in the analysis.|8.22|1.17|0.023
72409804|NCT02033889|144328104|SUPERIORITY||Difference in % vs Placebo|-16.2|||<|0.001|TWO_SIDED|95.0|-22.2|-11.2|||Miettinen & Nurminen method|Miettinen \& Nurminen method was used to construct both the 95% CI and derive p-value for the difference between the proportions (i.e. percentages).||||-11.2|-22.2|<0.001
72409805|NCT02033889|144328104|SUPERIORITY||Difference in % vs Placebo|-14.8|||<|0.001|TWO_SIDED|95.0|-20.9|-9.4|||Miettinen & Nurminen method.|Miettinen \& Nurminen method was used to construct both the 95% CI and derive p-value for the difference between the proportions (i.e. percentages).||||-9.4|-20.9|<0.001
72409806|NCT02033889|144328123|OTHER||Difference in the Least Squares Means|-0.1|||||TWO_SIDED|95.0|-0.71|0.5|||||||Based on cLDA model with fixed effects for treatment, time, prior antihyperglycemic medication (Metformin monotherapy or Metformin + another AHA), baseline eGFR (continuous), menopausal status, and the interaction of time by treatment. Time was treated as a categorical variable.|0.50|-0.71|
72409807|NCT02033889|144328123|OTHER||Difference in the Least Squares Means|-0.23|||||TWO_SIDED|97.0|-0.83|0.37|||||||Based on cLDA model with fixed effects for treatment, time, prior antihyperglycemic medication (Metformin monotherapy or Metformin + another AHA), baseline eGFR (continuous), menopausal status, and the interaction of time by treatment. Time was treated as a categorical variable.|0.37|-0.83|
72409808|NCT02033889|144328124|OTHER||Difference in the Least Squares Means|0.7|||||TWO_SIDED|95.0|0.0|1.39|||||||Based on cLDA model with fixed effects for treatment, time, prior antihyperglycemic medication (Metformin monotherapy or Metformin + another AHA), baseline eGFR (continuous), menopausal status, and the interaction of time by treatment. Time was treated as a categorical variable.|1.39|0.00|
72409809|NCT02033889|144328124|OTHER||Difference in the Least Squares Means|0.3|||||TWO_SIDED|95.0|-0.38|0.99|||||||Based on cLDA model with fixed effects for treatment, time, prior antihyperglycemic medication (Metformin monotherapy or Metformin + another AHA), baseline eGFR (continuous), menopausal status, and the interaction of time by treatment. Time was treated as a categorical variable.|0.99|-0.38|
72540501|NCT01236053|144610159|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.15||||0.7693|TWO_SIDED|95.0|0.45|2.92|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag)."|||2.92|0.45|0.7693
72540502|NCT01236053|144610159|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.9||||0.8189|TWO_SIDED|95.0|0.35|2.3|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy."|||2.30|0.35|0.8189
72540503|NCT01236053|144610159|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.99||||0.98|TWO_SIDED|95.0|0.5|1.98|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag)."|||1.98|0.50|0.9800
72540504|NCT01236053|144610159|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.78||||0.4944|TWO_SIDED|95.0|0.39|1.58|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy."|||1.58|0.39|0.4944
72540505|NCT01236053|144610160|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|20.0||||0.0144|TWO_SIDED|95.0|1.81|220.5|||Conditional Logistic Regression||"Comparison: Ever (without 2 year lag) and Never (without 2 year lag)."|||220.5|1.81|0.0144
72540506|NCT01236053|144610160|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|10.79||||0.0743|TWO_SIDED|95.0|0.79|147.0|||Conditional Logistic Regression||"Comparison: Ever (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy."|||147.0|0.79|0.0743
72540507|NCT01236053|144610161|SUPERIORITY_OR_OTHER||Unadjusted Odds Ratio|10.0||||0.1035|TWO_SIDED|95.0|0.63|159.9|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag)."|||159.9|0.63|0.1035
72540508|NCT01236053|144610161|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.1||||0.3799|TWO_SIDED|95.0|0.18|95.82|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy."|||95.82|0.18|0.3799
72575387|NCT03185013|144676782|SUPERIORITY|Superiority was concluded if the lower bound of the 95% CI exceeded 0.|Difference in median|50.83|||||TWO_SIDED|95.0|31.67|66.67||||||HPV-18 E6: Week 15||66.67|31.67|
72409810|NCT02033889|144328125|OTHER||Difference in the Least Squares Means|0.27|||||TWO_SIDED|95.0|-0.15|0.68|||||||Based on cLDA model with fixed effects for treatment, time, prior antihyperglycemic medication (Metformin monotherapy or Metformin + another AHA), baseline eGFR (continuous), menopausal status, and the interaction of time by treatment. Time was treated as a categorical variable.|0.68|-0.15|
72409811|NCT02033889|144328125|OTHER||Difference in the Least Squares Means|0.08|||||TWO_SIDED|95.0|-0.33|0.48|||||||Based on cLDA model with fixed effects for treatment, time, prior antihyperglycemic medication (Metformin monotherapy or Metformin + another AHA), baseline eGFR (continuous), menopausal status, and the interaction of time by treatment. Time was treated as a categorical variable.|0.48|-0.33|
72540509|NCT01236053|144610162|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|10.0||||0.1035|TWO_SIDED|95.0|0.63|159.9|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag)."|||159.9|0.63|0.1035
72540510|NCT01236053|144610162|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.1||||0.3799|TWO_SIDED|95.0|0.18|95.82|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy."|||95.82|0.18|0.3799
72575388|NCT03185013|144676782|SUPERIORITY|Superiority was concluded if the lower bound of the 95% CI exceeded 0.|Difference in median|38.33|||||TWO_SIDED|95.0|18.33|51.67||||||HPV-18 E6: Week 36||51.67|18.33|
72575389|NCT03185013|144676782|SUPERIORITY|Superiority was concluded if the lower bound of the 95% CI exceeded 0.|Difference in median|14.17|||||TWO_SIDED|95.0|6.67|18.33||||||HPV-18 E7: Week 15||18.33|6.67|
72575390|NCT03185013|144676782|SUPERIORITY|Superiority was concluded if the lower bound of the 95% CI exceeded 0.|Difference in median|10.0|||||TWO_SIDED|95.0|5.0|15.0||||||HPV-18 E7: Week 36||15.00|5.00|
72575391|NCT03185013|144676783|SUPERIORITY|Superiority was concluded if the lower bound of the 95% CI exceeded 0.|Difference in median|0.025|||||TWO_SIDED|95.0|0.002|0.046||||||Parameter: CD8+CD137+Perforin+||0.046|0.002|
72575392|NCT03185013|144676783|SUPERIORITY|Superiority was concluded if the lower bound of the 95% CI exceeded 0.|Difference in median|0.011|||||TWO_SIDED|95.0|0.0|0.014||||||Parameter: CD8+CD38+Perforin+||0.014|0.000|
72575393|NCT03185013|144676783|SUPERIORITY|Superiority was concluded if the lower bound of the 95% CI exceeded 0.|Difference in median|0.044|||||TWO_SIDED|95.0|0.017|0.058||||||Parameter: CD8+CD69+Perforin+||0.058|0.017|
72575394|NCT00673387|144676820|SUPERIORITY_OR_OTHER||||||<|0.0001||||||unadjusted for multiple comparisons; significance level of 0.0492 based on the Haybittle-Peto Criterion.|t-test, 2 sided|||When multiplicity not considered, sample size of 50 participants per arm (after dropouts) was considered adequate to detect a difference of 4.5% in mean body weight change from baseline to Week 28 between one effective pramlintide + metreleptin combination treatment group versus the placebo, Pramlintide 360 mcg BID + Placebo-M, or Metreleptin 5.0 mg BID + Placebo-P treatment arms with approximately 90% power, assuming a common within-treatment standard deviation of 6.858%.||||<0.0001
72575395|NCT00673387|144676820|SUPERIORITY_OR_OTHER|||||||0.0002||||||unadjusted for multiple comparisons; significance level of 0.0492 based on the Haybittle-Peto Criterion|t-test, 2 sided|||When multiplicity not considered, sample size of 50 participants per arm (after dropouts) was considered adequate to detect a difference of 4.5% in mean body weight change from baseline to Week 28 between one effective pramlintide + metreleptin combination treatment group versus the placebo, Pramlintide 360 mcg BID + Placebo-M, or Metreleptin 5.0 mg BID + Placebo-P treatment arms with approximately 90% power, assuming a common within-treatment standard deviation of 6.858%.||||0.0002
72575396|NCT00673387|144676820|SUPERIORITY_OR_OTHER|||||||0.0004||||||unadjusted for multiple comparisons; significance level of 0.0492 based on the Haybittle-Peto Criterion|t-test, 2 sided|||When multiplicity not considered, sample size of 50 participants per arm (after dropouts) was considered adequate to detect a difference of 4.5% in mean body weight change from baseline to Week 28 between one effective pramlintide + metreleptin combination treatment group versus the placebo, Pramlintide 360 mcg BID + Placebo-M, or Metreleptin 5.0 mg BID + Placebo-P treatment arms with approximately 90% power, assuming a common within-treatment standard deviation of 6.858%.||||0.0004
72575397|NCT00673387|144676820|SUPERIORITY_OR_OTHER||||||<|0.0001||||||unadjusted for multiple comparisons; significance level of 0.0492 based on the Haybittle-Peto Criterion|t-test, 2 sided|||||||<0.0001
72575398|NCT00673387|144676820|SUPERIORITY_OR_OTHER|||||||0.0001||||||unadjusted for multiple comparisons; significance level of 0.0492 based on the Haybittle-Peto Criterion|t-test, 2 sided|||||||0.0001
72575399|NCT00673387|144676820|SUPERIORITY_OR_OTHER|||||||0.251||||||unadjusted for multiple comparisons; significance level of 0.0492 based on the Haybittle-Peto Criterion|t-test, 2 sided|||When multiplicity not considered, sample size of 50 participants per arm (after dropouts) was considered adequate to detect a difference of 4.5% in mean body weight change from baseline to Week 28 between one effective pramlintide + metreleptin combination treatment group versus the placebo, Pramlintide 360 mcg BID + Placebo-M, or Metreleptin 5.0 mg BID + Placebo-P treatment arms with approximately 90% power, assuming a common within-treatment standard deviation of 6.858%.||||0.2510
72575400|NCT00673387|144676820|SUPERIORITY_OR_OTHER|||||||0.3433||||||unadjusted for multiple comparisons; significance level of 0.0492 based on the Haybittle-Peto Criterion|t-test, 2 sided|||When multiplicity not considered, sample size of 50 participants per arm (after dropouts) was considered adequate to detect a difference of 4.5% in mean body weight change from baseline to Week 28 between one effective pramlintide + metreleptin combination treatment group versus the placebo, Pramlintide 360 mcg BID + Placebo-M, or Metreleptin 5.0 mg BID + Placebo-P treatment arms with approximately 90% power, assuming a common within-treatment standard deviation of 6.858%.||||0.3433
72575401|NCT00673387|144676820|SUPERIORITY_OR_OTHER|||||||0.4503||||||unadjusted for multiple comparisons; significance level of 0.0492 based on the Haybittle-Peto Criterion|t-test, 2 sided|||When multiplicity not considered, sample size of 50 participants per arm (after dropouts) was considered adequate to detect a difference of 4.5% in mean body weight change from baseline to Week 28 between one effective pramlintide + metreleptin combination treatment group versus the placebo, Pramlintide 360 mcg BID + Placebo-M, or Metreleptin 5.0 mg BID + Placebo-P treatment arms with approximately 90% power, assuming a common within-treatment standard deviation of 6.858%.||||0.4503
72575402|NCT00673387|144676820|SUPERIORITY_OR_OTHER|||||||0.2122||||||unadjusted for multiple comparisons; significance level of 0.0492 based on the Haybittle-Peto Criterion|t-test, 2 sided|||When multiplicity not considered, sample size of 50 participants per arm (after dropouts) was considered adequate to detect a difference of 4.5% in mean body weight change from baseline to Week 28 between one effective pramlintide + metreleptin combination treatment group versus the placebo, Pramlintide 360 mcg BID + Placebo-M, or Metreleptin 5.0 mg BID + Placebo-P treatment arms with approximately 90% power, assuming a common within-treatment standard deviation of 6.858%.||||0.2122
72575403|NCT00673387|144676820|SUPERIORITY_OR_OTHER|||||||0.2232||||||unadjusted for multiple comparisons; significance level of 0.0492 based on the Haybittle-Peto Criterion|t-test, 2 sided|||When multiplicity not considered, sample size of 50 participants per arm (after dropouts) was considered adequate to detect a difference of 4.5% in mean body weight change from baseline to Week 28 between one effective pramlintide + metreleptin combination treatment group versus the placebo, Pramlintide 360 mcg BID + Placebo-M, or Metreleptin 5.0 mg BID + Placebo-P treatment arms with approximately 90% power, assuming a common within-treatment standard deviation of 6.858%.||||0.2232
72575404|NCT00673387|144676820|SUPERIORITY_OR_OTHER|||||||0.4207||||||unadjusted for multiple comparisons; significance level of 0.0492 based on the Haybittle-Peto Criterion.|t-test, 2 sided|||When multiplicity not considered, sample size of 50 participants per arm (after dropouts) was considered adequate to detect a difference of 4.5% in mean body weight change from baseline to Week 28 between one effective pramlintide + metreleptin combination treatment group versus the placebo, Pramlintide 360 mcg BID + Placebo-M, or Metreleptin 5.0 mg BID + Placebo-P treatment arms with approximately 90% power, assuming a common within-treatment standard deviation of 6.858%.||||0.4207
72576805|NCT00261443|144680655|SUPERIORITY_OR_OTHER_LEGACY||Difference|0.02||||0.838|TWO_SIDED|95.0|-0.17|0.21||Baseline: ANOVA model, controlling for treatment, mood stabilizer, and index mood episode. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 4 Comparison||0.21|-0.17|0.838
72409812|NCT02033889|144328126|OTHER||Difference in the Least Squares Means|-0.19|||||TWO_SIDED|95.0|-0.76|0.39|||||||Based on cLDA model with fixed effects for treatment, time, prior anti hyperglycemic medication (Metformin monotherapy or Metformin + another AHA), baseline eGFR (continuous), menopausal status, and the interaction of time by treatment. Time was treated as a categorical variable.|0.39|-0.76|
72409813|NCT02033889|144328126|OTHER||Difference in the Least Squares Means|-0.21|||||TWO_SIDED|95.0|-0.78|0.35|||||||Based on cLDA model with fixed effects for treatment, time, prior anti hyperglycemic medication (Metformin monotherapy or Metformin + another AHA), baseline eGFR (continuous), menopausal status, and the interaction of time by treatment. Time was treated as a categorical variable.|0.35|-0.78|
72540511|NCT01236053|144610164|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|10.0||||0.1035|TWO_SIDED|95.0|0.63|159.9|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag)."|||159.9|0.63|0.1035
72540512|NCT01236053|144610164|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.1||||0.3799|TWO_SIDED|95.0|0.18|95.82|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy."|||95.82|0.18|0.3799
72540513|NCT01236053|144610165|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.01||||0.0066|TWO_SIDED|95.0|1.21|3.32|||Conditional Logistic Regression||"Comparison: Ever (with 2 year lag) and Never (with 2 year lag)."|||3.32|1.21|0.0066
72540514|NCT01236053|144610165|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.68||||0.0494|TWO_SIDED|95.0|1.0|2.82|||Conditional Logistic Regression||"Comparison: Ever (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, chronic pancreatitis."|||2.82|1.00|0.0494
72540515|NCT01236053|144610165|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.93||||0.0006|TWO_SIDED|95.0|1.33|2.82|||Conditional Logistic Regression||"Comparison: Ever (without 2 year lag) and Never (without 2 year lag)."|||2.82|1.33|0.0006
72540516|NCT01236053|144610165|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.63||||0.0138|TWO_SIDED|95.0|1.11|2.41|||Conditional Logistic Regression||"Comparison: Ever (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, chronic pancreatitis."|||2.41|1.11|0.0138
72540517|NCT01236053|144610166|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.29||||0.0006|TWO_SIDED|95.0|1.66|6.53|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag)."|||6.53|1.66|0.0006
72575405|NCT00673387|144676820|SUPERIORITY_OR_OTHER|||||||0.5375||||||unadjusted for multiple comparisons; significance level of 0.0492 based on the Haybittle-Peto Criterion.|t-test, 2 sided|||When multiplicity not considered, sample size of 50 participants per arm (after dropouts) was considered adequate to detect a difference of 4.5% in mean body weight change from baseline to Week 28 between one effective pramlintide + metreleptin combination treatment group versus the placebo, Pramlintide 360 mcg BID + Placebo-M, or Metreleptin 5.0 mg BID + Placebo-P treatment arms with approximately 90% power, assuming a common within-treatment standard deviation of 6.858%||||0.5375
72540518|NCT01236053|144610166|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.01||||0.002|TWO_SIDED|95.0|1.5|6.05|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, chronic pancreatitis."|||6.05|1.50|0.0020
72540519|NCT01236053|144610166|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.49||||0.0013|TWO_SIDED|95.0|1.43|4.34|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag)."|||4.34|1.43|0.0013
72540520|NCT01236053|144610166|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.16||||0.008|TWO_SIDED|95.0|1.22|3.8|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, chronic pancreatitis."|||3.80|1.22|0.0080
72540521|NCT01236053|144610166|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.84||||0.8165|TWO_SIDED|95.0|0.2|3.61|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag)."|||3.61|0.20|0.8165
72540522|NCT01236053|144610166|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.72||||0.6624|TWO_SIDED|95.0|0.17|3.12|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, chronic pancreatitis."|||3.12|0.17|0.6624
72540523|NCT01236053|144610166|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.29||||0.6316|TWO_SIDED|95.0|0.45|3.68|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag)."|||3.68|0.45|0.6316
72540524|NCT01236053|144610166|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.07||||0.906|TWO_SIDED|95.0|0.35|3.22|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, chronic pancreatitis."|||3.22|0.35|0.9060
72540525|NCT01236053|144610166|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.51||||0.3731|TWO_SIDED|95.0|0.61|3.74|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag)."|||3.74|0.61|0.3731
72540526|NCT01236053|144610166|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.11||||0.8266|TWO_SIDED|95.0|0.43|2.87|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, chronic pancreatitis."|||2.87|0.43|0.8266
72540527|NCT01236053|144610166|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.73||||0.0712|TWO_SIDED|95.0|0.95|3.13|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag)."|||3.13|0.95|0.0712
72540528|NCT01236053|144610166|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.41||||0.2674|TWO_SIDED|95.0|0.77|2.6|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, chronic pancreatitis."|||2.60|0.77|0.2674
72540529|NCT01236053|144610167|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.61||||0.0005|TWO_SIDED|95.0|1.75|7.46|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag)."|||7.46|1.75|0.0005
72409814|NCT02033889|144328130|OTHER||Difference in the Least Squares Means|0.17|||||TWO_SIDED|95.0|-0.53|0.88|||||||Based on cLDA model with fixed effects for treatment, time, prior antihyperglycemic medication (Metformin monotherapy or Metformin + another AHA), baseline eGFR (continuous), menopausal status, and the interaction of time by treatment. Time was treated as a categorical variable.|0.88|-0.53|
72540530|NCT01236053|144610167|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.25||||0.0019|TWO_SIDED|95.0|1.55|6.83|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, chronic pancreatitis."|||6.83|1.55|0.0019
72540531|NCT01236053|144610167|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.51||||0.0024|TWO_SIDED|95.0|1.39|4.55|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag)."|||4.55|1.39|0.0024
72540532|NCT01236053|144610167|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.18||||0.0115|TWO_SIDED|95.0|1.19|4.0|||Wilcoxon (Mann-Whitney)||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, chronic pancreatitis."|||4.00|1.19|0.0115
72540533|NCT01236053|144610167|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.7||||0.6281|TWO_SIDED|95.0|0.17|2.96|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag)."|||2.96|0.17|0.6281
72540534|NCT01236053|144610167|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.61||||0.5103|TWO_SIDED|95.0|0.14|2.62|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, chronic pancreatitis."|||2.62|0.14|0.5103
72540535|NCT01236053|144610167|SUPERIORITY_OR_OTHER||Unadjusted Odds Ratio|1.15||||0.7733|TWO_SIDED|95.0|0.45|2.9|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag)."|||2.90|0.45|0.7733
72540536|NCT01236053|144610167|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.1||||0.837|TWO_SIDED|95.0|0.43|2.81|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, chronic pancreatitis."|||2.81|0.43|0.8370
72540537|NCT01236053|144610167|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.75||||0.198|TWO_SIDED|95.0|0.75|4.1|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag)."|||4.10|0.75|0.1980
72540538|NCT01236053|144610167|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.32||||0.5391|TWO_SIDED|95.0|0.54|3.21|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, chronic pancreatitis."|||3.21|0.54|0.5391
72540539|NCT01236053|144610167|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.97||||0.0224|TWO_SIDED|95.0|1.1|3.53|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag)."|||3.53|1.10|0.0224
72540540|NCT01236053|144610167|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.51||||0.1815|TWO_SIDED|95.0|0.82|2.77|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, chronic pancreatitis."|||2.77|0.82|0.1815
72540541|NCT01236053|144610169|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.38||||0.0248|TWO_SIDED|95.0|1.12|5.09|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag)."|||5.09|1.12|0.0248
72540542|NCT01236053|144610169|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.16||||0.052|TWO_SIDED|95.0|0.99|4.7|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, chronic pancreatitis."|||4.70|0.99|0.0520
72540543|NCT01236053|144610169|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.33||||0.0046|TWO_SIDED|95.0|1.3|4.2|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag)."|||4.20|1.30|0.0046
72540544|NCT01236053|144610169|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.05||||0.0193|TWO_SIDED|95.0|1.12|3.72|||Wilcoxon (Mann-Whitney)||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, chronic pancreatitis."|||3.72|1.12|0.0193
72540545|NCT01236053|144610169|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.75||||0.0309|TWO_SIDED|95.0|1.1|6.88|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag)."|||6.88|1.10|0.0309
72540546|NCT01236053|144610169|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.11||||0.1285|TWO_SIDED|95.0|0.81|5.51|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, chronic pancreatitis."|||5.51|0.81|0.1285
72540547|NCT01236053|144610169|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.8||||0.1257|TWO_SIDED|95.0|0.85|3.83|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag)."|||3.83|0.85|0.1257
72540548|NCT01236053|144610169|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.52||||0.2944|TWO_SIDED|95.0|0.7|3.31|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, chronic pancreatitis."|||3.31|0.70|0.2944
72540549|NCT01236053|144610169|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.21||||0.7032|TWO_SIDED|95.0|0.45|3.21|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag)."|||3.21|0.45|0.7032
72540550|NCT01236053|144610169|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.0||||0.9922|TWO_SIDED|95.0|0.37|2.69|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, chronic pancreatitis."|||2.69|0.37|0.9922
72540551|NCT01236053|144610169|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.66||||0.1227|TWO_SIDED|95.0|0.87|3.16|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag)."|||3.16|0.87|0.1227
72540552|NCT01236053|144610169|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.34||||0.3809|TWO_SIDED|95.0|0.69|2.61|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, chronic pancreatitis."|||2.61|0.69|0.3809
72540553|NCT01236053|144610170|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.64||||0.1757|TWO_SIDED|95.0|0.8|3.34|||Conditional Logistic Regression||"Comparison: Ever (with 2 year lag) and Never (with 2 year lag)."|||3.34|0.80|0.1757
72540554|NCT01236053|144610170|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.33||||0.4405|TWO_SIDED|95.0|0.64|2.75|||Conditional Logistic Regression||"Comparison: Ever (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, hypertension, diuretic use."|||2.75|0.64|0.4405
72409815|NCT02033889|144328130|OTHER||Difference in the Least Squares Means|-0.18|||||TWO_SIDED|97.0|-0.88|0.51|||||||Based on cLDA model with fixed effects for treatment, time, prior antihyperglycemic medication (Metformin monotherapy or Metformin + another AHA), baseline eGFR (continuous), menopausal status, and the interaction of time by treatment. Time was treated as a categorical variable.|0.51|-0.88|
72409816|NCT02033889|144328131|OTHER||Difference in the Least Squares Means|0.25|||||TWO_SIDED|95.0|-0.48|0.98|||||||Based on cLDA model with fixed effects for treatment, time, prior antihyperglycemic medication (Metformin monotherapy or Metformin + another AHA), baseline eGFR (continuous), menopausal status, and the interaction of time by treatment. Time was treated as a categorical variable.|0.98|-0.48|
72409817|NCT02033889|144328131|OTHER||Difference in the Least Squares Means|0.2|||||TWO_SIDED|95.0|-0.51|0.91|||||||Based on cLDA model with fixed effects for treatment, time, prior antihyperglycemic medication (Metformin monotherapy or Metformin + another AHA), baseline eGFR (continuous), menopausal status, and the interaction of time by treatment. Time was treated as a categorical variable.|0.91|-0.51|
72409818|NCT02033889|144328132|OTHER||Difference in the Least Squares Means|-0.5|||||TWO_SIDED|95.0|-0.95|-0.04|||||||Based on cLDA model with fixed effects for treatment, time, prior antihyperglycemic medication (Metformin monotherapy or Metformin + another AHA), baseline eGFR (continuous), menopausal status, and the interaction of time by treatment. Time was treated as a categorical variable.|-0.04|-0.95|
72409819|NCT02033889|144328132|OTHER||Difference in the Least Squares Means|-0.22|||||TWO_SIDED|95.0|-0.66|0.23|||||||Based on cLDA model with fixed effects for treatment, time, prior antihyperglycemic medication (Metformin monotherapy or Metformin + another AHA), baseline eGFR (continuous), menopausal status, and the interaction of time by treatment. Time was treated as a categorical variable.|0.23|-0.66|
72409820|NCT02033889|144328133|OTHER||Difference in the Least Squares Means|0.06|||||TWO_SIDED|95.0|-0.61|0.72|||||||Based on cLDA model with fixed effects for treatment, time, prior anti hyperglycemic medication (Metformin monotherapy or Metformin + another AHA), baseline eGFR (continuous), menopausal status, and the interaction of time by treatment. Time was treated as a categorical variable.|0.72|-0.61|
72540555|NCT01236053|144610170|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.24||||0.442|TWO_SIDED|95.0|0.71|2.16|||Conditional Logistic Regression||"Comparison: Ever (without 2 year lag) and Never (without 2 year lag)."|||2.16|0.71|0.4420
72409821|NCT02033889|144328133|OTHER||Difference in the Least Squares Means|-0.15|||||TWO_SIDED|95.0|-0.78|0.49|||||||Based on cLDA model with fixed effects for treatment, time, prior anti hyperglycemic medication (Metformin monotherapy or Metformin + another AHA), baseline eGFR (continuous), menopausal status, and the interaction of time by treatment. Time was treated as a categorical variable.|0.49|-0.78|
72540556|NCT01236053|144610170|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.04||||0.9034|TWO_SIDED|95.0|0.59|1.82|||Conditional Logistic Regression||"Comparison: Ever (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, hypertension, diuretic use."|||1.82|0.59|0.9034
72540557|NCT01236053|144610171|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.91||||0.2395|TWO_SIDED|95.0|0.65|5.6|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag)."|||5.60|0.65|0.2395
72540558|NCT01236053|144610171|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.64||||0.3764|TWO_SIDED|95.0|0.55|4.93|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, hypertension, diuretic use."|||4.93|0.55|0.3764
72540559|NCT01236053|144610171|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.14||||0.7599|TWO_SIDED|95.0|0.48|2.71|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag)."|||2.71|0.48|0.7599
72540560|NCT01236053|144610171|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.03||||0.9502|TWO_SIDED|95.0|0.43|2.46|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, hypertension, diuretic use."|||2.46|0.43|0.9502
72540561|NCT01236053|144610171|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.31||||0.7164|TWO_SIDED|95.0|0.3|5.75|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag)."|||5.75|0.30|0.7164
72540562|NCT01236053|144610171|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.06||||0.9345|TWO_SIDED|95.0|0.24|4.73|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, hypertension, diuretic use."|||4.73|0.24|0.9345
72540563|NCT01236053|144610171|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.91||||0.8833|TWO_SIDED|95.0|0.28|3.02|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag)."|||3.02|0.28|0.8833
72540564|NCT01236053|144610171|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.74||||0.6178|TWO_SIDED|95.0|0.22|2.46|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, hypertension, diuretic use."|||2.46|0.22|0.6178
72540565|NCT01236053|144610171|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.6||||0.4556|TWO_SIDED|95.0|0.46|5.53|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag)."|||5.53|0.46|0.4556
72409822|NCT02033889|144328137|OTHER||Difference in the Least Squares Means|-0.23|||||TWO_SIDED|95.0|-1.01|0.56|||||||Based on cLDA model with fixed effects for treatment, time, prior antihyperglycemic medication (Metformin monotherapy or Metformin + another AHA), baseline eGFR (continuous), menopausal status, and the interaction of time by treatment. Time was treated as a categorical variable.|0.56|-1.01|
72540566|NCT01236053|144610171|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.23||||0.7478|TWO_SIDED|95.0|0.35|4.29|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, hypertension, diuretic use."|||4.29|0.35|0.7478
72575406|NCT00673387|144676820|SUPERIORITY_OR_OTHER|||||||0.6633||||||unadjusted for multiple comparisons; significance level of 0.0492 based on the Haybittle-Peto Criterion|t-test, 2 sided|||When multiplicity not considered, sample size of 50 participants per arm (after dropouts) was considered adequate to detect a difference of 4.5% in mean body weight change from baseline to Week 28 between one effective pramlintide + metreleptin combination treatment group versus the placebo, Pramlintide 360 mcg BID + Placebo-M, or Metreleptin 5.0 mg BID + Placebo-P treatment arms with approximately 90% power, assuming a common within-treatment standard deviation of 6.858%||||0.6633
72575407|NCT00673387|144676820|SUPERIORITY_OR_OTHER|||||||0.3667||||||unadjusted for multiple comparisons; significance level of 0.0492 based on the Haybittle-Peto Criterion|t-test, 2 sided|||When multiplicity not considered, sample size of 50 participants per arm (after dropouts) was considered adequate to detect a difference of 4.5% in mean body weight change from baseline to Week 28 between one effective pramlintide + metreleptin combination treatment group versus the placebo, Pramlintide 360 mcg BID + Placebo-M, or Metreleptin 5.0 mg BID + Placebo-P treatment arms with approximately 90% power, assuming a common within-treatment standard deviation of 6.858%.||||0.3667
72627536|NCT00565409|144783929|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.97||||0.1278|TWO_SIDED|95.0|0.4|42.5||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 36 Low Disease Activity||42.5|0.4|0.1278
72409823|NCT02033889|144328137|OTHER||Difference in the Least Squares Means|-0.28|||||TWO_SIDED|97.0|-1.06|0.5|||||||Based on cLDA model with fixed effects for treatment, time, prior antihyperglycemic medication (Metformin monotherapy or Metformin + another AHA), baseline eGFR (continuous), menopausal status, and the interaction of time by treatment. Time was treated as a categorical variable.|0.50|-1.06|
72540567|NCT01236053|144610171|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.71||||0.235|TWO_SIDED|95.0|0.71|4.13|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag)."|||4.13|0.71|0.2350
72627537|NCT00565409|144783929|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.63|||<|0.0001|TWO_SIDED|95.0|2.1|6.4||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 40 Low Disease Activity||6.4|2.1|<0.0001
72540568|NCT01236053|144610171|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.32||||0.5428|TWO_SIDED|95.0|0.54|3.24|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, hypertension, diuretic use."|||3.24|0.54|0.5428
72627538|NCT00565409|144783929|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.43||||0.3027|TWO_SIDED|95.0|0.8|2.7||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 40 Low Disease Activity||2.7|0.8|0.3027
72627539|NCT00565409|144783929|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.51|||<|0.0001|TWO_SIDED|95.0|1.5|4.2||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 40 Low Disease Activity||4.2|1.5|<0.0001
72627540|NCT00565409|144783929|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.55|||<|0.0001|TWO_SIDED|95.0|2.7|7.6||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 48 Low Disease Activity||7.6|2.7|<0.0001
72627541|NCT00565409|144783929|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.18||||0.5871|TWO_SIDED|95.0|0.7|2.1||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 48 Low Disease Activity||2.1|0.7|0.5871
72627542|NCT00565409|144783929|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.76|||<|0.0001|TWO_SIDED|95.0|2.3|6.1||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 48 Low Disease Activity||6.1|2.3|<0.0001
72627543|NCT00565409|144783929|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.52|||<|0.0001|TWO_SIDED|95.0|3.9|11.0||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 56 Low Disease Activity||11.0|3.9|<0.0001
72627544|NCT00565409|144783929|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.14||||0.6716|TWO_SIDED|95.0|0.6|2.0||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 56 Low Disease Activity||2.0|0.6|0.6716
72627545|NCT00565409|144783929|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.4|||<|0.0001|TWO_SIDED|95.0|3.4|8.6||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 56 Low Disease Activity||8.6|3.4|<0.0001
72627546|NCT00565409|144783929|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.62|||<|0.0001|TWO_SIDED|95.0|2.8|7.6||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 64 Low Disease Activity||7.6|2.8|<0.0001
72627547|NCT00565409|144783929|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.88||||0.9399|TWO_SIDED|95.0|0.5|1.5||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 64 Low Disease Activity||1.5|0.5|0.9399
72627548|NCT00565409|144783929|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.78|||<|0.0001|TWO_SIDED|95.0|3.0|7.7||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 64 Low Disease Activity||7.7|3.0|<0.0001
72627549|NCT00565409|144783929|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.25|||<|0.0001|TWO_SIDED|95.0|3.7|10.5||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 72 Low Disease Activity||10.5|3.7|<0.0001
72575408|NCT00673387|144676820|SUPERIORITY_OR_OTHER|||||||0.372||||||unadjusted for multiple comparisons; significance level of 0.0492 based on the Haybittle-Peto Criterion.|t-test, 2 sided|||When multiplicity not considered, sample size of 50 participants per arm (after dropouts) was considered adequate to detect a difference of 4.5% in mean body weight change from baseline to Week 28 between one effective pramlintide + metreleptin combination treatment group versus the placebo, Pramlintide 360 mcg BID + Placebo-M, or Metreleptin 5.0 mg BID + Placebo-P treatment arms with approximately 90% power, assuming a common within-treatment standard deviation of 6.858%.||||0.3720
72575409|NCT00673387|144676824|SUPERIORITY_OR_OTHER|||||||0.0404|||||||t-test, 2 sided|||Change at Week 28 based on a general linear model with factors for treatment group, sex, baseline BMI category, and baseline value as a covariate||||0.0404
72575410|NCT00673387|144676824|SUPERIORITY_OR_OTHER|||||||0.0265|||||||t-test, 2 sided|||Change at Week 28 based on a general linear model with factors for treatment group, sex, baseline BMI category, and baseline value as a covariate.||||0.0265
72575411|NCT00673387|144676824|SUPERIORITY_OR_OTHER|||||||0.1357|||||||t-test, 2 sided|||Change at Week 28 based on a general linear model with factors for treatment group, sex, baseline BMI category, and baseline value as a covariate.||||0.1357
72575412|NCT00673387|144676824|SUPERIORITY_OR_OTHER|||||||0.0409|||||||t-test, 2 sided|||Change at Week 28 based on a general linear model with factors for treatment group, sex, baseline BMI category, and baseline value as a covariate.||||0.0409
72627550|NCT00565409|144783929|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.08||||0.6692|TWO_SIDED|95.0|0.6|1.9||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 72 Low Disease Activity||1.9|0.6|0.6692
72627551|NCT00565409|144783929|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.46|||<|0.0001|TWO_SIDED|95.0|3.4|8.7||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 72 Low Disease Activity||8.7|3.4|<0.0001
72627552|NCT00565409|144783929|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.74|||<|0.0001|TWO_SIDED|95.0|3.4|9.8||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 80 Low Disease Activity||9.8|3.4|<0.0001
72540569|NCT01236053|144610172|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.9||||0.3123|TWO_SIDED|95.0|0.55|6.59|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag)."|||6.59|0.55|0.3123
72540570|NCT01236053|144610172|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.73||||0.3951|TWO_SIDED|95.0|0.49|6.15|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, hypertension, diuretic use."|||6.15|0.49|0.3951
72540571|NCT01236053|144610172|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.45||||0.4388|TWO_SIDED|95.0|0.56|3.75|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag)."|||3.75|0.56|0.4388
72540572|NCT01236053|144610172|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.34||||0.5535|TWO_SIDED|95.0|0.51|3.47|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, hypertension, diuretic use."|||3.47|0.51|0.5535
72540573|NCT01236053|144610172|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.34||||0.6332|TWO_SIDED|95.0|0.4|4.48|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag)."|||4.48|0.40|0.6332
72540574|NCT01236053|144610172|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.1||||0.8743|TWO_SIDED|95.0|0.32|3.75|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, hypertension, diuretic use."|||3.75|0.32|0.8743
72540575|NCT01236053|144610172|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.77||||0.6132|TWO_SIDED|95.0|0.27|2.15|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag)."|||2.15|0.27|0.6132
72540576|NCT01236053|144610172|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|0.63||||0.3821|TWO_SIDED|95.0|0.22|1.78|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, hypertension, diuretic use."|||1.78|0.22|0.3821
72540577|NCT01236053|144610172|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.8||||0.3591|TWO_SIDED|95.0|0.51|6.28|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag)."|||6.28|0.51|0.3591
72540578|NCT01236053|144610172|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.29||||0.6899|TWO_SIDED|95.0|0.37|4.58|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, hypertension, diuretic use."|||4.58|0.37|0.6899
72540579|NCT01236053|144610172|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.78||||0.2031|TWO_SIDED|95.0|0.73|4.3|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag)."|||4.30|0.73|0.2031
72540580|NCT01236053|144610172|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.37||||0.4932|TWO_SIDED|95.0|0.56|3.37|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, hypertension, diuretic use."|||3.37|0.56|0.4932
72540581|NCT01236053|144610174|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.64||||0.0843|TWO_SIDED|95.0|0.88|7.96|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag)."|||7.96|0.88|0.0843
72540582|NCT01236053|144610174|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.71||||0.081|TWO_SIDED|95.0|0.88|8.28|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, hypertension, diuretic use."|||8.28|0.88|0.0810
72540583|NCT01236053|144610174|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.43||||0.4583|TWO_SIDED|95.0|0.55|3.7|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag)."|||3.70|0.55|0.4583
72540584|NCT01236053|144610174|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.43||||0.4622|TWO_SIDED|95.0|0.55|3.73|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, hypertension, diuretic use."|||3.73|0.55|0.4622
72540585|NCT01236053|144610174|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.45||||0.5512|TWO_SIDED|95.0|0.43|4.95|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag)."|||4.95|0.43|0.5512
72540586|NCT01236053|144610174|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.06||||0.9277|TWO_SIDED|95.0|0.31|3.67|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, hypertension, diuretic use."|||3.67|0.31|0.9277
72540587|NCT01236053|144610174|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.23||||0.6402|TWO_SIDED|95.0|0.51|2.95|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag)."|||2.95|0.51|0.6402
72540588|NCT01236053|144610174|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.96||||0.9256|TWO_SIDED|95.0|0.4|2.32|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, hypertension, diuretic use."|||2.32|0.40|0.9256
72540589|NCT01236053|144610174|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.05||||0.9514|TWO_SIDED|95.0|0.24|4.5|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag)."|||4.50|0.24|0.9514
72540590|NCT01236053|144610174|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.79||||0.7543|TWO_SIDED|95.0|0.18|3.44|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, hypertension, diuretic use."|||3.44|0.18|0.7543
72540591|NCT01236053|144610174|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.08||||0.8781|TWO_SIDED|95.0|0.38|3.07|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag)."|||3.07|0.38|0.8781
72540592|NCT01236053|144610174|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.84||||0.7429|TWO_SIDED|95.0|0.29|2.4|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, hypertension, diuretic use."|||2.40|0.29|0.7429
72540593|NCT02340078|144610176|SUPERIORITY||Subjects % with difference in VAS ≥ 10mm|0.9516|||||TWO_SIDED|95.0|0.87|0.99||||||||0.99|0.87|
72540594|NCT01311505|144610177|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|98.9|||||TWO_SIDED|90.0|92.98|105.2||||||20 participants (10 per sequence) provided at least 98% power that 90% confidence interval (CI) for ratio of test to reference for AUC(0-t) of rifampicin lie within acceptance region of 80%-125%. Intra-participant coefficient of variation (CV) estimate of approximately 13.48% for AUC(0-t) was used for this power calculation. Natural log transformed AUC(0-t) was analyzed using mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as random effect.||105.20|92.98|
72540595|NCT01311505|144610178|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|98.24|||||TWO_SIDED|90.0|87.77|109.97||||||20 participants (10 per sequence) provided at least 94% power that 90% CI for ratio of test to reference for Cmax of rifampicin lie within acceptance region of 80%-125%. Intra-participant CV estimate of approximately 16.43% for Cmax was used for this power calculation. Natural log transformed Cmax was analyzed using mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as random effect.||109.97|87.77|
72540596|NCT01311505|144610180|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|100.25|||||TWO_SIDED|90.0|94.44|106.41||||||Natural log transformed AUC(0-∞) of rifampicin was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||106.41|94.44|
72540597|NCT00883129|144610195|SUPERIORITY_OR_OTHER|||||||0.24||||||The threshold for statistical significance was a P-Value of \</=0.05.|Mixed Models Analysis|||A modified intention-to-treat inferential joint model combined a mixed-effects model for longitudinal outcomes and a survival model to handle non-ignorable missing data due to study dropout, treatment failure, or death, to assess the course over time, from baseline to 24 months, for the change in the FVC %-predicted. Covariates were %-predicted FVC, HRCT-defined extent of lung fibrosis in the lobe of maximum involvement, and terms for time-trend, treatment and treatment-time trend interactions.||||0.24
72540598|NCT00883129|144610195|SUPERIORITY_OR_OTHER||||||<|0.05||||||The threshold for statistical significance was a P-Value of \</=0.05.|Mixed Models Analysis|||The inferential joint model, as described for the primary analysis, was used to estimate the change from baseline to 24 months for the FVC %-predicted for each treatment arm independently.||||<0.05
72540599|NCT00883129|144610195|SUPERIORITY_OR_OTHER|||||||0.55||||||The threshold for statistical significance was a P-Value of \</=0.05.|Fisher Exact|||Based on the absolute difference between the value of FVC %-predicted at baseline and at 24 months for each subject who returned for a 24-month assessment, a frequency distributions was prepared, stratified by treatment arm, to assess the relative distribution of subjects who either had improvements or worsening in the FVC %-predicted.||||0.55
72575413|NCT00673387|144676824|SUPERIORITY_OR_OTHER|||||||0.0082|||||||t-test, 2 sided|||Change at Week 28 based on a general linear model with factors for treatment group, sex, baseline BMI category, and baseline value as a covariate.||||0.0082
72409824|NCT02033889|144328138|OTHER||Difference in the Least Squares Means|0.27|||||TWO_SIDED|95.0|-0.58|1.13|||||||Based on cLDA model with fixed effects for treatment, time, prior antihyperglycemic medication (Metformin monotherapy or Metformin + another AHA), baseline eGFR (continuous), menopausal status, and the interaction of time by treatment. Time was treated as a categorical variable.|1.13|-0.58|
72409825|NCT02033889|144328138|OTHER||Difference in the Least Squares Means|0.12|||||TWO_SIDED|95.0|-0.7|0.93|||||||Based on cLDA model with fixed effects for treatment, time, prior antihyperglycemic medication (Metformin monotherapy or Metformin + another AHA), baseline eGFR (continuous), menopausal status, and the interaction of time by treatment. Time was treated as a categorical variable.|0.93|-0.70|
72409826|NCT02033889|144328139|OTHER||Difference in the Least Squares Means|-0.84|||||TWO_SIDED|95.0|-1.44|-0.24|||||||Based on cLDA model with fixed effects for treatment, time, prior antihyperglycemic medication (Metformin monotherapy or Metformin + another AHA), baseline eGFR (continuous), menopausal status, and the interaction of time by treatment. Time was treated as a categorical variable.|-0.24|-1.44|
72540600|NCT00883129|144610196|SUPERIORITY_OR_OTHER||||||>|0.05||||||The threshold for statistical significance was a P-Value of \</=0.05.|Mixed Models Analysis|||A modified intention-to-treat inferential joint model combined a mixed-effects model for longitudinal outcomes and a survival model to handle non-ignorable missing data due to study dropout, treatment failure, or death, to assess the course over time, from baseline to 24 months, for the change in the TLC %-predicted.||||>0.05
72540601|NCT00883129|144610197|SUPERIORITY_OR_OTHER||||||<|0.001||||||The threshold for statistical significance was a P-Value of \</=0.05.|Mixed Models Analysis|||A modified intention-to-treat inferential joint model combined a mixed-effects model for longitudinal outcomes and a survival model to handle non-ignorable missing data due to study dropout, treatment failure, or death, to assess the course over time, from baseline to 24 months, for the change in the DLCO %-predicted.||||<0.001
72540602|NCT00883129|144610197|SUPERIORITY_OR_OTHER||||||>|0.05||||||The threshold for statistical significance was a P-Value of \</=0.05.|Mixed Models Analysis|||The inferential joint model, as described for the primary analysis, was used to estimate the change from baseline to 24 months for the DLCO %-predicted for each treatment arm independently.||||>0.05
72540603|NCT00883129|144610198|SUPERIORITY_OR_OTHER||||||>|0.05||||||The threshold for statistical significance was a P-Value of \</=0.05.|Mixed Models Analysis|||A modified intention-to-treat inferential joint model combined a mixed-effects model for longitudinal outcomes and a survival model to handle non-ignorable missing data due to study dropout, treatment failure, or death, to assess the course over time, from baseline to 24 months, for the change in the Quantitative Lung Fibrosis Score for the whole lung (QLF-WL).||||>0.05
72540604|NCT00883129|144610199|SUPERIORITY_OR_OTHER||||||>|0.05||||||The threshold for statistical significance was a P-Value of \</=0.05.|Mixed Models Analysis|||A modified intention-to-treat inferential joint model combined a mixed-effects model for longitudinal outcomes and a survival model to handle non-ignorable missing data due to study dropout, treatment failure, or death, to assess the course over time, from baseline to 24 months, for the change in dyspnea as measured by the Transitional Dyspnea Index Score.||||>0.05
72540605|NCT00883129|144610199|SUPERIORITY_OR_OTHER||||||<|0.05||||||The threshold for statistical significance was a P-Value of \</=0.05.|Mixed Models Analysis|||The inferential joint model, as described for the primary analysis, was used to estimate the change from baseline to 24 months for dyspnea using the Transitional Dyspnea Index Score for each treatment arm independently.||||<0.05
72540606|NCT00883129|144610201|SUPERIORITY_OR_OTHER||||||>|0.05||||||The threshold for statistical significance was a P-Value of \</=0.05.|Mixed Models Analysis|||A modified intention-to-treat inferential joint model combined a mixed-effects model for longitudinal outcomes and a survival model to handle non-ignorable missing data due to study dropout, treatment failure, or death, to assess the course over time, from baseline to 24 months, for the change in modified Rodnan Skin Score (mRSS).||||>0.05
72540607|NCT00883129|144610201|SUPERIORITY_OR_OTHER||||||<|0.05||||||The threshold for statistical significance was a P-Value of \</=0.05.|Mixed Models Analysis|||The inferential joint model, as described for the primary analysis, was used to estimate the change from baseline to 24 months for the modified Rodnan Skin Score for each treatment arm independently.||||<0.05
72540608|NCT00883129|144610201|SUPERIORITY_OR_OTHER||||||>|0.05||||||The threshold for statistical significance was a P-Value of \</=0.05.|Fisher Exact|||Based on the absolute difference between the value of the mRSS at baseline and at 24 months for each subject who returned for a 24-month assessment, a frequency distributions was prepared, stratified by treatment arm, to assess the relative distribution of subjects who either had improvements or worsening in the mRSS.||||>0.05
72540609|NCT00883129|144610202|SUPERIORITY_OR_OTHER||||||<|0.05||||||The threshold for statistical significance was a P-Value of \</=0.05.|Fisher Exact|The threshold for statistical significance was met only for the frequency of leukopenia and thrombocytopenia, but not for total SAE or death.||Fisher's Exact Test was utilized to compare the number of participants with a protocol-defined adverse event of interest, SAE or death between the MMF and CYC treatment arms.||||<0.05
72540610|NCT00883129|144610203|SUPERIORITY_OR_OTHER|||||||0.019||||||The threshold for statistical significance was a P-Value of \</=0.05.|Log Rank|||A log-rank test was utilized to assess differences between the MMF and CYC treatment arms with respect to the time to withdrawal from study drug or meeting protocol-defined criteria for treatment failure.||||0.019
72540611|NCT00759759|144610235|NON_INFERIORITY_OR_EQUIVALENCE|The 90% confidence intervals for the ratios (test/reference) of the least squares means of the non-transformed parameters Cmax, AUClast, AUCinf, Tmax, λz, and T1/2, were calculated.|mean ratio|90.46||||||90.0|82.9|98.7|||ANOVA|||ANOVA of ln-transformed plasma morphine Cmax||98.7|82.9|
72540612|NCT00759759|144610237|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA performed on the ratio of geometric means|mean ratio|101.1||||||90.0|96.9|105.4|||ANOVA|||Statistical analysis of ln-transformed plasma morphine AUClast||105.4|96.9|
72627553|NCT00565409|144783929|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.2||||0.4326|TWO_SIDED|95.0|0.7|2.1||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 80 Low Disease Activity||2.1|0.7|0.4326
72409827|NCT02033889|144328139|OTHER||Difference in the least Squares Means|-0.54|||||TWO_SIDED|95.0|-1.12|0.05|||||||Based on cLDA model with fixed effects for treatment, time, prior antihyperglycemic medication (Metformin monotherapy or Metformin + another AHA), baseline eGFR (continuous), menopausal status, and the interaction of time by treatment. Time was treated as a categorical variable.|0.05|-1.12|
72409828|NCT02033889|144328140|OTHER||Difference in the Least Squares Means|-0.06|||||TWO_SIDED|95.0|-0.77|0.65|||||||Based on cLDA model with fixed effects for treatment, time, prior anti hyperglycemic medication (Metformin monotherapy or Metformin + another AHA), baseline eGFR (continuous), menopausal status, and the interaction of time by treatment. Time was treated as a categorical variable.|0.65|-0.77|
72409829|NCT02033889|144328140|OTHER||Difference in the Least Squares Means|0.18|||||TWO_SIDED|95.0|-0.5|0.85|||||||Based on cLDA model with fixed effects for treatment, time, prior anti hyperglycemic medication (Metformin monotherapy or Metformin + another AHA), baseline eGFR (continuous), menopausal status, and the interaction of time by treatment. Time was treated as a categorical variable.|0.85|-0.50|
72540613|NCT00759759|144610238|NON_INFERIORITY_OR_EQUIVALENCE|The 90% confidence intervals for the ratios (test/reference) of the least squares means of the non-transformed parameters Cmax, AUClast, AUCinf, Tmax, λz, and T1/2, were calculated.|mean ratio|101.3||||||90.0|96.2|106.7|||ANOVA|||||106.7|96.2|
72540614|NCT00391092|144610244|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.82||||0.0775|TWO_SIDED|95.0|0.65|1.02|||Log Rank (unstratified)|||||1.02|0.65|0.0775
72409830|NCT02348489|144328146|SUPERIORITY||Difference in response rate (%)|1.92||||0.482|TWO_SIDED|96.0|-3.67|7.5|||Cochran-Mantel-Haenszel|||The complete response rate was compared between the treatment groups using a Cochran Mantel-Haenszel (CMH) test at an alpha level of 0.04 stratified to adjust for stratification factors used at randomization: age (\<75 or \>=75), Eastern Cooperative Oncology Group (ECOG) performance status (0-1, 2-3), study center region (North American, Europe, Rest of World), and secondary AML (secondary to MDS or other antecedent hematologic disorder) or poor-risk cytogenetics (Yes, No/Unknown).||7.5|-3.67|0.482
72409831|NCT02348489|144328147|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.7328|TWO_SIDED|95.0|0.83|1.14|||Stratified log-rank|||Overall survival curves were estimated using Kaplan-Meier method and compared between the treatment groups using a 2-sided stratification log-rank test, stratified by the same factors used at randomization: age (\<75 or \>=75), Eastern Cooperative Oncology Group (ECOG) performance status (0-1, 2-3), study center region (North American, Europe, Rest of World), and secondary AML (secondary to MDS or other antecedent hematologic disorder) or poor-risk cytogenetics (Yes, No/Unknown).||1.14|0.83|0.7328
72540615|NCT00391092|144610245|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.01||||0.9543|TWO_SIDED|95.0|0.74|1.38|||Log Rank|||||1.38|0.74|0.9543
72540616|NCT00391092|144610246|SUPERIORITY_OR_OTHER||Difference in Response rates|4.43||||0.3492|TWO_SIDED|95.0|-5.2|14.0|||Chi-squared||95% CI for the difference in response rates using Hauck-Anderson method.|||14.0|-5.2|0.3492
72540617|NCT00391092|144610247|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.74|||||TWO_SIDED|95.0|0.56|0.98||||||||0.98|0.56|
72540618|NCT00391092|144610248|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.94||||0.5392|TWO_SIDED|95.0|0.76|1.15|||Log Rank|||||1.15|0.76|0.5392
72540619|NCT02437890|144610262|SUPERIORITY||||||=|0.526||||||Threshold for statistical significance: p = 0.05|Multiple Contrast Test|||"A multiple contrast test was used to establish evidence of a drug effect by testing for a statistically significant dose-response signal for clinical endpoint and patient population investigated in the study. Candidate dose-response models were selected amongst the following types of parametric models: linear model, Emax model, logistic model, a 1st Beta model, and a 2nd Beta model.~Model tested: linear model"||||= 0.526
72540620|NCT02437890|144610262|SUPERIORITY||||||=|0.504||||||Threshold for statistical significance: p = 0.05|Multiple Contrast Test|||"A multiple contrast test was used to establish evidence of a drug effect by testing for a statistically significant dose-response signal for clinical endpoint and patient population investigated in the study. Candidate dose-response models were selected amongst the following types of parametric models: linear model, Emax model, logistic model, a 1st Beta model, and a 2nd Beta model.~Model tested: Emax model"||||= 0.504
72540621|NCT02437890|144610262|SUPERIORITY||||||=|0.548||||||Threshold for statistical significance: p = 0.05|Multiple Contrast Test|||"A multiple contrast test was used to establish evidence of a drug effect by testing for a statistically significant dose-response signal for clinical endpoint and patient population investigated in the study. Candidate dose-response models were selected amongst the following types of parametric models: linear model, Emax model, logistic model, a 1st Beta model, and a 2nd Beta model.~Model tested: logistic model"||||= 0.548
72540622|NCT02437890|144610262|SUPERIORITY||||||=|0.985||||||Threshold for statistical significance: p = 0.05|Multiple Contrast Test|||"A multiple contrast test was used to establish evidence of a drug effect by testing for a statistically significant dose-response signal for clinical endpoint and patient population investigated in the study. Candidate dose-response models were selected amongst the following types of parametric models: linear model, Emax model, logistic model, a 1st Beta model, and a 2nd Beta model.~Model tested: 1st Beta model"||||= 0.985
72540623|NCT02437890|144610262|SUPERIORITY||||||=|0.524||||||Threshold for statistical significance: p = 0.05|Multiple Contrast Test|||"A multiple contrast test was used to establish evidence of a drug effect by testing for a statistically significant dose-response signal for clinical endpoint and patient population investigated in the study. Candidate dose-response models were selected amongst the following types of parametric models: linear model, Emax model, logistic model, a 1st Beta model, and a 2nd Beta model.~Model tested: 2nd Beta model"||||= 0.524
72542663|NCT00575328|144615283|SUPERIORITY|Analysis is a test of statistical significance to evaluate whether the results are consistent with the assumption of there being no difference in the clinical improvement (i.e. change in ASEX score) of the two treatments (null hypothesis).|Mean Difference (Final Values)|1.8|STANDARD_DEVIATION|3.3||0.62|TWO_SIDED|95.0|-8.7|12.3||No adjustment for multiple comparisons. P value for significance set a priori at P\<0.05.|t-test, 2 sided|||Null hypothesis: There will be no difference in clinical improvement (i.e. change in ASEX score) between treatment arms. No formal power analysis was carried out, given the small study sample.|The analysis is not truly informative, since the analyzable sample (n=6) was too small. Results should be viewed with caution.|12.3|-8.7|0.62
72575414|NCT00673387|144676828|SUPERIORITY_OR_OTHER|||||||0.0464|||||||t-test, 2 sided|||Based on a general linear model general linear model that includes baseline value and factors for treatment group, sex, baseline BMI category (\<35 kg/m2, 35 to \<40 kg/m2, ≥40 kg/m2).||||0.0464
72575415|NCT00673387|144676828|SUPERIORITY_OR_OTHER|||||||0.0647|||||||t-test, 2 sided|||Based on a general linear model general linear model that includes baseline value and factors for treatment group, sex, baseline BMI category (\<35 kg/m2, 35 to \<40 kg/m2, ≥40 kg/m2).||||0.0647
72575416|NCT00673387|144676828|SUPERIORITY_OR_OTHER|||||||0.069|||||||t-test, 2 sided|||Based on a general linear model general linear model that includes baseline value and factors for treatment group, sex, baseline BMI category (\<35 kg/m2, 35 to \<40 kg/m2, ≥40 kg/m2).||||0.0690
72575417|NCT00673387|144676828|SUPERIORITY_OR_OTHER|||||||0.3717|||||||t-test, 2 sided|||Based on a general linear model general linear model that includes baseline value and factors for treatment group, sex, baseline BMI category (\<35 kg/m2, 35 to \<40 kg/m2, ≥40 kg/m2).||||0.3717
72575418|NCT00673387|144676828|SUPERIORITY_OR_OTHER|||||||0.0327|||||||t-test, 2 sided|||Based on a general linear model general linear model that includes baseline value and factors for treatment group, sex, baseline BMI category (\<35 kg/m2, 35 to \<40 kg/m2, ≥40 kg/m2).||||0.0327
72575419|NCT00673387|144676829|SUPERIORITY_OR_OTHER|||||||0.0049|||||||t-test, 2 sided|||Based on a general linear model general linear model that includes baseline value and factors for treatment group, sex, baseline BMI category (\<35 kg/m2, 35 to \<40 kg/m2, ≥40 kg/m2).||||0.0049
72575420|NCT00673387|144676829|SUPERIORITY_OR_OTHER|||||||0.0047|||||||t-test, 2 sided|||Based on a general linear model general linear model that includes baseline value and factors for treatment group, sex, baseline BMI category (\<35 kg/m2, 35 to \<40 kg/m2, ≥40 kg/m2).||||0.0047
72575421|NCT00673387|144676829|SUPERIORITY_OR_OTHER|||||||0.0046|||||||t-test, 2 sided|||Based on a general linear model general linear model that includes baseline value and factors for treatment group, sex, baseline BMI category (\<35 kg/m2, 35 to \<40 kg/m2, ≥40 kg/m2).||||0.0046
72575422|NCT00673387|144676829|SUPERIORITY_OR_OTHER|||||||0.0257|||||||t-test, 2 sided|||Based on a general linear model general linear model that includes baseline value and factors for treatment group, sex, baseline BMI category (\<35 kg/m2, 35 to \<40 kg/m2, ≥40 kg/m2).||||0.0257
72575423|NCT00673387|144676829|SUPERIORITY_OR_OTHER|||||||0.0014|||||||t-test, 2 sided|||Based on a general linear model general linear model that includes baseline value and factors for treatment group, sex, baseline BMI category (\<35 kg/m2, 35 to \<40 kg/m2, ≥40 kg/m2).||||0.0014
72575424|NCT00673387|144676830|SUPERIORITY_OR_OTHER|||||||0.0222|||||||t-test, 2 sided|||Based on a general linear model general linear model that includes baseline value and factors for treatment group, sex, baseline BMI category (\<35 kg/m2, 35 to \<40 kg/m2, ≥40 kg/m2).||||0.0222
72575425|NCT00673387|144676830|SUPERIORITY_OR_OTHER|||||||0.0128|||||||t-test, 2 sided|||Based on a general linear model general linear model that includes baseline value and factors for treatment group, sex, baseline BMI category (\<35 kg/m2, 35 to \<40 kg/m2, ≥40 kg/m2).||||0.0128
72575426|NCT00673387|144676830|SUPERIORITY_OR_OTHER|||||||0.0122|||||||t-test, 2 sided|||Based on a general linear model general linear model that includes baseline value and factors for treatment group, sex, baseline BMI category (\<35 kg/m2, 35 to \<40 kg/m2, ≥40 kg/m2).||||0.0122
72575427|NCT00673387|144676830|SUPERIORITY_OR_OTHER|||||||0.0073|||||||t-test, 2 sided|||Based on a general linear model general linear model that includes baseline value and factors for treatment group, sex, baseline BMI category (\<35 kg/m2, 35 to \<40 kg/m2, ≥40 kg/m2).||||0.0073
72575428|NCT00673387|144676830|SUPERIORITY_OR_OTHER|||||||0.0034|||||||t-test, 2 sided|||Based on a general linear model general linear model that includes baseline value and factors for treatment group, sex, baseline BMI category (\<35 kg/m2, 35 to \<40 kg/m2, ≥40 kg/m2).||||0.0034
72575429|NCT00960115|144676847|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.953||||0.828|TWO_SIDED|95.0|0.614|1.479||This trial was not powered to demonstrate statistical significance of treatment differences with respect to a statistical test, i.e., the p value being lower than a significance level of alpha (α) = 0.05.|Log Rank||Cox proportional hazards regression model|||1.479|0.614|0.828
72575430|NCT01197755|144676852|SUPERIORITY_OR_OTHER||Weighted difference in proportion|0.17||||0.004|TWO_SIDED|95.0|0.05|0.28||Week 24|Mantel Haenszel|Treatment difference in proportion of responders at Week 24 with a Mantel-Haenszel approach stratified by pooled country.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||0.28|0.05|0.004
72575431|NCT01197755|144676852|SUPERIORITY_OR_OTHER||Weighted difference in proportion|0.07||||0.168|TWO_SIDED|95.0|-0.03|0.18||Week 24|Mantel Haenszel|Treatment difference in proportion of responders at Week 24 with a Mantel-Haenszel approach stratified by pooled country.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||0.18|-0.03|0.168
72575432|NCT01197755|144676853|SUPERIORITY_OR_OTHER||Weighted difference in proportion|0.22|||<|0.001|TWO_SIDED|95.0|0.16|0.29|||Mantel Haenszel|95% confidence intervals and p-values are calculated using a Mantel-Haenszel approach stratified by pooled country.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||0.29|0.16|<0.001
72575433|NCT01197755|144676854|SUPERIORITY_OR_OTHER||Weighted difference in proportion|0.1||||0.014|TWO_SIDED|95.0|0.02|0.19|||Mantel Haenszel|95% confidence intervals and p-values are calculated using a Mantel-Haenszel approach stratified by pooled country.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||0.19|0.02|0.014
72576806|NCT00261443|144680655|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.11||||0.291|TWO_SIDED|95.0|-0.32|0.1||Baseline: ANOVA model, controlling for treatment, mood stabilizer, and index mood episode. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 8 Comparison||0.10|-0.32|0.291
72627554|NCT00565409|144783929|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.12|||<|0.0001|TWO_SIDED|95.0|3.2|8.2||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 80 Low Disease Activity||8.2|3.2|<0.0001
72627555|NCT00565409|144783929|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.68|||<|0.0001|TWO_SIDED|95.0|2.8|7.8||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 88 Low Disease Activity||7.8|2.8|<0.0001
72627556|NCT00565409|144783929|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.03||||0.6064|TWO_SIDED|95.0|0.6|1.8||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 88 Low Disease Activity||1.8|0.6|0.6064
72627557|NCT00565409|144783929|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.68|||<|0.0001|TWO_SIDED|95.0|3.0|7.4||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 88 Low Disease Activity||7.4|3.0|<0.0001
72627558|NCT00565409|144783929|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.3||||0.4626|TWO_SIDED|95.0|0.5|3.3||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 36 Remission||3.3|0.5|0.4626
72575434|NCT01197755|144676854|SUPERIORITY_OR_OTHER||Weighted difference in proportion|0.05||||0.18|TWO_SIDED|95.0|-0.02|0.12||Nominal p-value presented for Group B comparison. Formal statistical testing could not be carried out due to the predefined multiplicity procedure (primary variable comparison of Group B versus Group C was non-significant).|Mantel Haenszel|95% confidence intervals and p-values are calculated using a Mantel-Haenszel approach stratified by pooled country.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||0.12|-0.02|0.180
72627559|NCT00565409|144783929|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.44||||0.2886|TWO_SIDED|95.0|0.6|3.3||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 36 Remission||3.3|0.6|0.2886
72627560|NCT00565409|144783929|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.83||||0.7779|TWO_SIDED|95.0|0.4|1.9||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 36 Remission||1.9|0.4|0.7779
72627561|NCT00565409|144783929|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.94|||<|0.0001|TWO_SIDED|95.0|1.8|4.7||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 40 Remission||4.7|1.8|<0.0001
72627562|NCT00565409|144783929|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.26||||0.2091|TWO_SIDED|95.0|0.8|2.0||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 40 Remission||2.0|0.8|0.2091
72627563|NCT00565409|144783929|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.31|||<|0.0001|TWO_SIDED|95.0|1.5|3.6||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 40 Remission||3.6|1.5|<0.0001
72575435|NCT01197755|144676855|SUPERIORITY_OR_OTHER||Weighted difference in proportion|0.12|||<|0.001|TWO_SIDED|95.0|0.06|0.19|||Mantel Haenszel|95% confidence intervals and p-values are calculated using a Mantel-Haenszel approach stratified by pooled country.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||0.19|0.06|<0.001
72627564|NCT00565409|144783929|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.33|||<|0.0001|TWO_SIDED|95.0|2.1|5.2||p-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 48 Remission||5.2|2.1|<0.0001
72627565|NCT00565409|144783929|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.11||||0.5351|TWO_SIDED|95.0|0.7|1.7||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 48 Remission||1.7|0.7|0.5351
72627566|NCT00565409|144783929|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.12|||<|0.0001|TWO_SIDED|95.0|2.0|4.8||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 48 Remission||4.8|2.0|<0.0001
72627567|NCT00565409|144783929|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.09|||<|0.0001|TWO_SIDED|95.0|2.6|6.5||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 56 Remission||6.5|2.6|<0.0001
72627568|NCT00565409|144783929|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.86||||0.4574|TWO_SIDED|95.0|0.5|1.3||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 56 Remission||1.3|0.5|0.4574
72627569|NCT00565409|144783929|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.04|||<|0.0001|TWO_SIDED|95.0|3.2|8.0||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 56 Remission||8.0|3.2|<0.0001
72627570|NCT00565409|144783929|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.19|||<|0.0001|TWO_SIDED|95.0|2.7|6.6||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 64 Remission||6.6|2.7|<0.0001
72627571|NCT00565409|144783929|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.14||||0.5229|TWO_SIDED|95.0|0.7|1.8||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 64 Remission||1.8|0.7|0.5229
72627572|NCT00565409|144783929|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.84|||<|0.0001|TWO_SIDED|95.0|2.5|6.0||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 64 Remission||6.0|2.5|<0.0001
72540624|NCT02414854|144610303|SUPERIORITY|Hierarchical testing procedure was used to control type I error rate at 0.05 level. The procedure included the 2 primary outcome measures and the first 13 secondary outcome measures reported and considered 2 pair-wise comparisons: Dupilumab 200 mg q2w vs Placebo (for Dupilumab 200 mg) q2w and Dupilumab 300 mg q2w vs Placebo (for Dupilumab 300 mg) q2w. Testing order is specified in analysis description.|Relative risk|0.54|||<|0.0001|TWO_SIDED|95.0|0.43|0.68||Hierarchical testing sequence performed continued only when previous outcome measures was statistically significant at 0.05. Threshold for significance at 0.05 level.|Negative binomial regression model||Dupilumab 300 mg q2w vs Placebo (for Dupilumab 300 mg) q2w|Analysis was performed using negative binomial model with total number of events onset from randomization up to Week 52 or last contact date (whichever comes earlier) as response variable; with 4 treatment groups, age, region, baseline eosinophil strata, baseline ICS dose level, number of severe exacerbation events within 1 year prior to study as covariates; and log transformed standardized observation duration as an offset variable. Here, it is test no. 1 of testing order.||0.68|0.43|<0.0001
72540625|NCT02414854|144610303|SUPERIORITY|Testing according to the hierarchical testing procedure (performed only if previous outcome measures were statistically significant).|Relative risk|0.523|||<|0.0001|TWO_SIDED|95.0|0.413|0.662||Threshold for significance at 0.05 level.|Negative binomial regression model||Dupilumab 200 mg q2w vs Placebo (for Dupilumab 200 mg) q2w|Analysis was performed using negative binomial model with total number of events onset from randomization up to Week 52 or last contact date (whichever comes earlier) as response variable; with 4 treatment groups, age, region, baseline eosinophil strata, baseline ICS dose level, number of severe exacerbation events within 1 year prior to study as covariates; and log transformed standardized observation duration as an offset variable. Here, it is test no. 3 of testing order.||0.662|0.413|<0.0001
72540626|NCT02414854|144610304|SUPERIORITY|Testing according to the hierarchical testing procedure (performed only if previous outcome measures were statistically significant).|Least Square (LS) Mean Difference|0.13|||<|0.0001|TWO_SIDED|95.0|0.08|0.18||Threshold for significance at 0.05 level.|Mixed Models Analysis||Dupilumab 300 mg q2w vs Placebo (for Dupilumab 300 mg) q2w|Analysis was performed using mixed-effect model with repeated measures (MMRM) model with change from baseline in FEV1 values up to Week 12 as response variable; and treatment, age, sex, baseline height, region, baseline eosinophil strata, baseline ICS dose level, visit, treatment by-visit interaction, baseline FEV1 value and baseline-by-visit interaction as covariates. Here, it is test no. 2 of testing order.||0.18|0.08|<0.0001
72540627|NCT02414854|144610304|SUPERIORITY|Testing according to the hierarchical testing procedure (performed only if previous outcome measures were statistically significant).|LS Mean Difference|0.14|||<|0.0001|TWO_SIDED|95.0|0.08|0.19||Threshold for significance at 0.05 level.|Mixed Models Analysis||Dupilumab 200 mg q2w vs Placebo (for Dupilumab 200 mg) q2w|Analysis was performed using MMRM model with change from baseline in FEV1 values up to Week 12 as response variable; and treatment, age, sex, baseline height, region, baseline eosinophil strata, baseline ICS dose level, visit, treatment by-visit interaction, baseline FEV1 value and baseline-by-visit interaction as covariates. Here, it is test no. 4 of testing order.||0.19|0.08|<0.0001
72540628|NCT02414854|144610305|SUPERIORITY|Testing according to the hierarchical testing procedure (performed only if previous outcome measures were statistically significant).|LS Mean Difference|9.41|||<|0.0001|TWO_SIDED|95.0|5.74|13.07||Threshold for significance at 0.05 level.|Mixed Models Analysis||Dupilumab 300 mg q2w vs Placebo (for Dupilumab 300 mg) q2w|Analysis performed using MMRM model(n=954 for 300 vs placebo)with percent change from baseline in FEV1 values up to Week 12 as response variable; \& treatment, age, sex, baseline height, region, baseline eosinophil strata, baseline ICS dose level, visit, treatment by-visit interaction, baseline FEV1 value \& baseline-by-visit interaction as covariates. Hierarchical testing procedure used to control type I error \& handle multiple secondary endpoint analyses. Here, it is test no. 5 of testing order.||13.07|5.74|<0.0001
72540629|NCT02414854|144610306|SUPERIORITY|Testing according to the hierarchical testing procedure (performed only if previous outcome measures were statistically significant).|Relative risk|0.402|||<|0.0001|TWO_SIDED|95.0|0.307|0.526||Threshold for significance at 0.05 level.|Negative binomial regression model||Dupilumab 300 mg q2w vs Placebo (for Dupilumab 300 mg) q2w|Analysis was performed using negative binomial model with total number of events onset from randomization up to Week 52 or last contact date (whichever comes earlier) as response variable; with 4 treatment groups, age, region, baseline eosinophil strata, baseline ICS dose level, number of severe exacerbation events within 1 year prior to study as covariates; and log transformed standardized observation duration as an offset variable. Here, it is test no. 6 of testing order.||0.526|0.307|<0.0001
72540630|NCT02414854|144610307|SUPERIORITY|Testing according to the hierarchical testing procedure (performed only if previous outcome measures were statistically significant).|LS Mean Difference|0.15|||<|0.0001|TWO_SIDED|95.0|0.09|0.21||Threshold for significance at 0.05 level.|Mixed Models Analysis||Dupilumab 300 mg q2w vs Placebo (for Dupilumab 300 mg) q2w|Analysis was performed using MMRM model with change from baseline in FEV1 values up to Week 12 as response variable; and treatment, age, sex, baseline height, region, baseline eosinophil strata, baseline ICS dose level, visit, treatment by-visit interaction, baseline FEV1 value and baseline-by-visit interaction as covariates. Here, it is test no. 7 of testing order.||0.21|0.09|<0.0001
72540631|NCT02414854|144610308|SUPERIORITY|Testing according to the hierarchical testing procedure (performed only if previous outcome measures were statistically significant).|Relative risk|0.326|||<|0.0001|TWO_SIDED|95.0|0.234|0.454||Threshold for significance at 0.05 level.|Negative binomial regression model||Dupilumab 300 mg q2w vs Placebo (for Dupilumab 300 mg) q2w|Analysis was performed using negative binomial model with total number of events onset from randomization up to Week 52 or last contact date (whichever comes earlier) as response variable; with 4 treatment groups, age, region, baseline eosinophil strata, baseline ICS dose level, number of severe exacerbation events within 1 year prior to study as covariates; and log transformed standardized observation duration as an offset variable. Here, it is test no. 8 of testing order.||0.454|0.234|<0.0001
72540632|NCT02414854|144610309|SUPERIORITY|Testing according to the hierarchical testing procedure (performed only if previous outcome measures were statistically significant).|LS Mean Difference|0.24|||<|0.0001|TWO_SIDED|95.0|0.16|0.32||Threshold for significance at 0.05 level.|Mixed Models Analysis||Dupilumab 300 mg q2w vs Placebo (for Dupilumab 300 mg) q2w|Analysis was performed using MMRM model with change from baseline in FEV1 values up to Week 12 as response variable; and treatment, age, sex, baseline height, region, baseline eosinophil strata, baseline ICS dose level, visit, treatment by-visit interaction, baseline FEV1 value and baseline-by-visit interaction as covariates. Here, it is test no. 9 of testing order.||0.32|0.16|<0.0001
72540633|NCT02414854|144610310|SUPERIORITY|Testing according to the hierarchical testing procedure (performed only if previous outcome measures were statistically significant).|Relative risk|0.834||||0.2599|TWO_SIDED|95.0|0.608|1.144||Threshold for significance at 0.05 level.|Negative binomial regression model||Dupilumab 300 mg q2w vs Placebo (for Dupilumab 300 mg) q2w|Analysis was performed using negative binomial model with total number of events onset from randomization up to Week 52 or last contact date (whichever comes earlier) as response variable; with 4 treatment groups, age, region, baseline eosinophil strata, baseline ICS dose level, number of severe exacerbation events within 1 year prior to study as covariates; and log transformed standardized observation duration as an offset variable. Here, it is test no. 10 of testing order.||1.144|0.608|0.2599
72540634|NCT02625207|144610358|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio|116.73||||0.1318|TWO_SIDED|90.0|98.55|138.26|||Mixed Models Analysis|||||138.26|98.55|0.1318
72540635|NCT02625207|144610358|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio|85.85||||0.1369|TWO_SIDED|90.0|72.48|101.68|||Mixed Models Analysis|||||101.68|72.48|0.1369
72540636|NCT02625207|144610358|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio|63.38|||<|0.0001|TWO_SIDED|90.0|53.51|75.07|||Mixed Models Analysis|||||75.07|53.51|< 0.0001
72540637|NCT02625207|144610358|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio|73.83||||0.0036|TWO_SIDED|90.0|62.57|87.13|||Mixed Models Analysis|||||87.13|62.57|0.0036
72575436|NCT01197755|144676855|SUPERIORITY_OR_OTHER||Weighted difference in proportion|0.0||||0.891|TWO_SIDED|95.0|-0.04|0.04||Nominal p-value presented for Group B comparison. Formal statistical testing could not be carried out due to the predefined multiplicity procedure (primary variable comparison of Group B versus Group C was non-significant).|Mantel Haenszel|95% confidence intervals and p-values are calculated using a Mantel-Haenszel approach stratified by pooled country.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||0.04|-0.04|0.891
72575437|NCT01197755|144676856|SUPERIORITY_OR_OTHER||Treatment difference|||||0.01||||||Nominal p-value presented for treatment comparison. ACRn was not formally tested within the predefined multiplicity procedure. As this is a non-parametric test p-values alone are presented rather than an estimated treatment difference.|Van Elteren|P-values are estimated using the Van Elteren test stratified by pooled country.||Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||||0.010
72575438|NCT01197755|144676856|SUPERIORITY_OR_OTHER|||||||0.019||||||Nominal p-value presented for treatment comparison. ACRn was not formally tested within the predefined multiplicity procedure. As this is a non-parametric test p-values alone are presented rather than an estimated treatment difference.|Van Elteren|P-values are estimated using the Van Elteren test stratified by pooled country.||Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||||0.019
72575439|NCT01197755|144676857|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.1||||0.023|TWO_SIDED|95.0|1.21|13.91|||Regression, Logistic|Odds ratio and 95% confidence intervals are calculated using Logistic Regression with treatment and pooled country as factors.|An odds ratio of \>1 indicates a benefit towards fostamatinib.|Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||13.91|1.21|0.023
72575440|NCT01197755|144676857|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.3||||0.197|TWO_SIDED|95.0|0.65|8.23||Nominal p-value presented for Group B comparison. Formal statistical testing could not be carried out due to the predefined multiplicity procedure (primary variable comparison of Group B versus Group C was non-significant).|Regression, Logistic|Odds ratio and 95% confidence intervals are calculated using Logistic Regression with treatment and pooled country as factors.|An odds ratio of \>1 indicates a benefit towards fostamatinib.|Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||8.23|0.65|0.197
72575441|NCT01197755|144676858|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.1||||0.005|TWO_SIDED|95.0|1.54|10.92|||Regression, Logistic|Odds ratio and 95% confidence intervals are calculated using Logistic Regression with treatment and pooled country as factors.|An odds ratio of \>1 indicates a benefit towards fostamatinib.|Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||10.92|1.54|0.005
72576807|NCT00261443|144680655|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.14||||0.219|TWO_SIDED|95.0|-0.37|0.08||Baseline: ANOVA model, controlling for treatment, mood stabilizer, and index mood episode. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 12 Comparison||0.08|-0.37|0.219
72576808|NCT00261443|144680655|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.18||||0.133|TWO_SIDED|95.0|-0.41|0.05||Baseline: ANOVA model, controlling for treatment, mood stabilizer, and index mood episode. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 16 Comparison||0.05|-0.41|0.133
72576809|NCT00261443|144680655|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.21||||0.092|TWO_SIDED|95.0|-0.46|0.04||Baseline: ANOVA model, controlling for treatment, mood stabilizer, and index mood episode. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 20 Comparison||0.04|-0.46|0.092
72576810|NCT00261443|144680655|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.31||||0.018|TWO_SIDED|95.0|-0.56|-0.05||Baseline: ANOVA model, controlling for treatment, mood stabilizer, and index mood episode. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 24 Comparison||-0.05|-0.56|0.018
72540638|NCT02625207|144610358|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean ratio|73.99||||0.0038|TWO_SIDED|90.0|62.7|87.31|||Mixed Models Analysis|||||87.31|62.70|0.0038
72540639|NCT02625207|144610359|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio|82.59||||0.0531|TWO_SIDED|90.0|70.33|96.98|||Mixed Models Analysis|||||96.98|70.33|0.0531
72540640|NCT02625207|144610360|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio|137.07||||0.0106|TWO_SIDED|90.0|112.4|167.15|||Mixed Models Analysis|||Statistical analysis of PF -6857639 was estimated and reported.||167.15|112.40|0.0106
72540641|NCT02625207|144610360|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio|164.06||||0.0001|TWO_SIDED|90.0|134.54|200.06|||Mixed Models Analysis|||Statistical analysis of PF -6857639 was estimated and reported.||200.06|134.54|0.0001
72540642|NCT02625207|144610360|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio|198.49|||<|0.0001|TWO_SIDED|90.0|162.77|242.05|||Mixed Models Analysis|||Statistical analysis of PF -6857639 was estimated and reported.||242.05|162.77|< 0.0001
72540643|NCT02625207|144610360|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio|120.99||||0.1061|TWO_SIDED|90.0|99.65|146.9|||Mixed Models Analysis|||Statistical analysis of PF -6857639 was estimated and reported.||146.90|99.65|0.1061
72540644|NCT02625207|144610360|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio|272.07|||<|0.0001|TWO_SIDED|90.0|224.08|330.33|||Mixed Models Analysis|||Statistical analysis of PF -6857639 was estimated and reported.||330.33|224.08|<0.0001
72540645|NCT02625207|144610360|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio|110.22||||0.3081|TWO_SIDED|90.0|94.05|129.18|||Mixed Models Analysis|||Statistical analysis of PF -6857640 was estimated and reported.||129.18|94.05|0.3081
72627573|NCT00565409|144783929|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.36|||<|0.0001|TWO_SIDED|95.0|3.3|8.6||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 72 Remission||8.6|3.3|<0.0001
72627574|NCT00565409|144783929|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.15||||0.6464|TWO_SIDED|95.0|0.7|1.8||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 72 Remission||1.8|0.7|0.6464
72540646|NCT02625207|144610360|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio|101.71||||0.8583|TWO_SIDED|90.0|86.79|119.2|||Mixed Models Analysis|||Statistical analysis of PF -6857640 was estimated and reported.||119.20|86.79|0.8583
72540647|NCT02625207|144610360|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio|108.52||||0.3913|TWO_SIDED|90.0|92.6|127.17|||Mixed Models Analysis|||Statistical analysis of PF -6857640 was estimated and reported.||127.17|92.60|0.3913
72540648|NCT02625207|144610360|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio|106.69||||0.4866|TWO_SIDED|90.0|91.36|124.6|||Mixed Models Analysis|||Statistical analysis of PF -6857640 was estimated and reported.||124.60|91.36|0.4866
72627575|NCT00565409|144783929|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.79|||<|0.0001|TWO_SIDED|95.0|3.0|7.6||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 72 Remission||7.6|3.0|<0.0001
72540649|NCT02625207|144610360|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio|119.61||||0.059|TWO_SIDED|90.0|102.42|139.69|||Mixed Models Analysis|||Statistical analysis of PF -6857640 was estimated and reported.||139.69|102.42|0.0590
72540650|NCT02625207|144610360|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio|99.7||||0.9816|TWO_SIDED|90.0|80.47|123.53|||Mixed Models Analysis|||Statistical analysis of PF -06927572 was estimated and reported.||123.53|80.47|0.9816
72540651|NCT02625207|144610360|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio|105.12||||0.6974|TWO_SIDED|90.0|84.84|130.24|||Mixed Models Analysis|||Statistical analysis of PF -06927572 was estimated and reported.||130.24|84.84|0.6974
72540652|NCT02625207|144610360|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio|101.03||||0.9363|TWO_SIDED|90.0|81.54|125.18|||Mixed Models Analysis|||Statistical analysis of PF -06927572 was estimated and reported.||125.18|81.54|0.9363
72540653|NCT02625207|144610360|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio|96.11||||0.752|TWO_SIDED|90.0|77.94|118.52|||Mixed Models Analysis|||Statistical analysis of PF -06927572 was estimated and reported.||118.52|77.94|0.7520
72540654|NCT02625207|144610360|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio|100.73||||0.9536|TWO_SIDED|90.0|81.69|124.22|||Mixed Models Analysis|||Statistical analysis of PF -06927572 was estimated and reported.||124.22|81.69|0.9536
72540655|NCT02625207|144610360|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio|97.6||||0.8241|TWO_SIDED|90.0|81.28|117.18|||Mixed Models Analysis|||Statistical analysis of PF -06927573 was estimated and reported.||117.18|81.28|0.8241
72540656|NCT02625207|144610360|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio|118.5||||0.1261|TWO_SIDED|90.0|98.69|142.28|||Mixed Models Analysis|||Statistical analysis of PF -06927573 was estimated and reported.||142.28|98.69|0.1261
72540657|NCT02625207|144610360|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio|99.6||||0.9708|TWO_SIDED|90.0|82.95|119.59|||Mixed Models Analysis|||Statistical analysis of PF -06927573 was estimated and reported.||119.59|82.95|0.9708
72540658|NCT02625207|144610360|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio|84.05||||0.1099|TWO_SIDED|90.0|70.29|100.52|||Mixed Models Analysis|||Statistical analysis of PF -06927573 was estimated and reported.||100.52|70.29|0.1099
72540659|NCT02625207|144610360|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio|97.21||||0.7913|TWO_SIDED|90.0|81.29|116.25|||Mixed Models Analysis|||Statistical analysis of PF -06927573 was estimated and reported.||116.25|81.29|0.7913
72540660|NCT02625207|144610361|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio|116.65||||0.1338|TWO_SIDED|90.0|98.47|138.18|||Mixed Models Analysis|||||138.18|98.47|0.1338
72540661|NCT02625207|144610361|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio|85.84||||0.137|TWO_SIDED|90.0|72.46|101.68|||Mixed Models Analysis|||||101.68|72.46|0.1370
72540662|NCT02625207|144610361|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio|63.34|||<|0.0001|TWO_SIDED|90.0|53.47|75.04|||Mixed Models Analysis|||||75.04|53.47|< 0.0001
72540663|NCT02625207|144610361|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean ratio|73.79||||0.0036|TWO_SIDED|90.0|62.53|87.09|||Mixed Models Analysis|||||87.09|62.53|0.0036
72540664|NCT02625207|144610361|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio|73.89||||0.0037|TWO_SIDED|90.0|62.61|87.2|||Mixed Models Analysis|||||87.20|62.61|0.0037
72627576|NCT00565409|144783929|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.96|||<|0.0001|TWO_SIDED|95.0|3.1|7.9||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 80 Remission||7.9|3.1|<0.0001
72409832|NCT01639001|144328155|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.402|||<|0.0001|TWO_SIDED|95.0|0.286|0.565||The study was to be considered positive if the 1-sided log-rank test for PFS, stratified for baseline stratification factors (ECOG PS, ethnicity, and brain metastases) was significant at the 0.02496level.|1 sided stratified log-rank||Based on the Cox Proportional hazards model stratified by ECOG PS, ethnicity, and brain metastases. Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of crizotinib.|The study was designed to test the null hypothesis H0: λ=1.0 versus the alternative hypothesis HA: λ \< 1.0, where λ is the hazard ratio (HR; Crizotinib/Chemotherapy). Evaluation of 160 PFS events in the 2 arms using a 1-sided log-rank test at the 0.025 level of significance was required to detect a HR of 0.64 with 80% power.||0.565|0.286|<0.0001
72627577|NCT00565409|144783929|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.13||||0.5499|TWO_SIDED|95.0|0.7|1.7||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 80 Remission||1.7|0.7|0.5499
72627578|NCT00565409|144783929|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.11|||<|0.0001|TWO_SIDED|95.0|2.6|6.4|||Cochran-Mantel-Haenszel|||Week 80 Remission||6.4|2.6|<0.0001
72627579|NCT00565409|144783929|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.41|||<|0.0001|TWO_SIDED|95.0|2.8|7.0||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 88 Remission||7.0|2.8|<0.0001
72627580|NCT00565409|144783929|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.2||||0.1109|TWO_SIDED|95.0|0.8|1.9||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 88 Remission||1.9|0.8|0.1109
72627581|NCT00565409|144783929|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.85|||<|0.0001|TWO_SIDED|95.0|2.5|6.0||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 88 Remission||6.0|2.5|<0.0001
72627582|NCT00565409|144783931|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.54|||<|0.0001|TWO_SIDED|95.0|-0.7|-0.4|||ANCOVA|ANCOVA model: Change = Week 36 score + treatment + geographic region.||Week 40||-0.4|-0.7|<0.0001
72409833|NCT01639001|144328156|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|41.869|||<|0.0001|TWO_SIDED|95.0|30.34|53.398||If the PFS endpoint was significant, ORR was to be considered significant if 2-sided p-value from Pearson chi-square test was \<= 0.04992.|2-sided pearson chi-square test||Treatment difference in ORR (%)|The confidence interval for the treatment difference was based on normal distribution.||53.398|30.340|<0.0001
72540665|NCT02625207|144610362|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio|82.42||||0.0507|TWO_SIDED|90.0|70.2|96.77|||Mixed Models Analysis|||||96.77|70.20|0.0507
72540666|NCT02625207|144610363|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio|118.19||||0.1997|TWO_SIDED|90.0|95.26|146.63|||Mixed Models Analysis|||||146.63|95.26|0.1997
72627583|NCT00565409|144783931|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01||||0.9344|TWO_SIDED|95.0|-0.2|0.2|||ANCOVA|ANCOVA model: Change = Week 36 score + treatment + geographic region.||Week 40||0.2|-0.2|0.9344
72627584|NCT00565409|144783931|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.53|||<|0.0001|TWO_SIDED|95.0|-0.7|-0.4|||ANCOVA|ANCOVA model: Change = Week 36 score + treatment + geographic region.||Week 40||-0.4|-0.7|<0.0001
72627585|NCT00565409|144783931|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.84|||<|0.0001|TWO_SIDED|95.0|-1.0|-0.7|||ANCOVA|ANCOVA model: Change = Week 36 score + treatment + geographic region.||Week 48||-0.7|-1.0|<0.0001
72627586|NCT00565409|144783931|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.05||||0.6173|TWO_SIDED|95.0|-0.1|0.2|||ANCOVA|ANCOVA model: Change = Week 36 score + treatment + geographic region.||Week 48||0.2|-0.1|0.6173
72627587|NCT00565409|144783931|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.89|||<|0.0001|TWO_SIDED|95.0|-1.1|-0.7|||ANCOVA|ANCOVA model: Change = Week 36 score + treatment + geographic region.||Week 48||-0.7|-1.1|<0.0001
72627588|NCT00565409|144783931|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.92|||<|0.0001|TWO_SIDED|95.0|-1.1|-0.7|||ANCOVA|ANCOVA model: Change = Week 36 score + treatment + geographic region.||Week 56||-0.7|-1.1|<0.0001
72627589|NCT00565409|144783931|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.06||||0.5136|TWO_SIDED|95.0|-0.1|0.3|||ANCOVA|ANCOVA model: Change = Week 36 score + treatment + geographic region.||Week 56||0.3|-0.1|0.5136
72540667|NCT02625207|144610363|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio|87.28||||0.2947|TWO_SIDED|90.0|70.34|108.28|||Mixed Models Analysis|||||108.28|70.34|0.2947
72575442|NCT01197755|144676858|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.7||||0.002|TWO_SIDED|95.0|1.79|12.3||Nominal p-value presented for Group B comparison. Formal statistical testing could not be carried out due to the predefined multiplicity procedure (primary variable comparison of Group B versus Group C was non-significant).|Regression, Logistic|Odds ratio and 95% confidence intervals are calculated using Logistic Regression with treatment and pooled country as factors.|An odds ratio of \>1 indicates a benefit towards fostamatinib.|Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||12.30|1.79|0.002
72575443|NCT01197755|144676859|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.27|||<|0.001|TWO_SIDED|95.0|1.86|5.76||Nominal p value only. This was not included in the pre-defined multiplicity testing procedure.|Proportional odds model|No response, moderate response and good response are included in the proportional odds model with treatment and pooled country as factors.|An odds ratio \>1 indicates a benefit towards fostamatinib.|Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data||5.76|1.86|<0.001
72575444|NCT01197755|144676859|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.89||||0.028|TWO_SIDED|95.0|1.07|3.31||Nominal p-value only. This was not included in the pre-defined multiplicity testing procedure.|Proportional odds model|No response, moderate response and good response are included in the proportional odds model with treatment and pooled country as factors.|An odds ratio \>1 indicates a benefit towards fostamatinib.|Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data||3.31|1.07|0.028
72540668|NCT02625207|144610363|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio|61.23||||0.0004|TWO_SIDED|90.0|49.35|75.97|||Mixed Models Analysis|||||75.97|49.35|0.0004
72540669|NCT02625207|144610363|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio|70.16||||0.0071|TWO_SIDED|90.0|56.81|86.63|||Mixed Models Analysis|||||86.63|56.81|0.0071
72540670|NCT02625207|144610363|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio|72.37||||0.0135|TWO_SIDED|90.0|58.6|89.36|||Mixed Models Analysis|||||89.36|58.60|0.0135
72540671|NCT02625207|144610364|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio|68.32||||0.0505|TWO_SIDED|90.0|49.81|93.71|||Mixed Models Analysis|||||93.71|49.81|0.0505
72540672|NCT02625207|144610365|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio|94.83||||0.6761|TWO_SIDED|90.0|76.7|117.24|||Mixed Models Analysis|||||117.24|76.70|0.6761
72540673|NCT02625207|144610365|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio|105.43||||0.6771||90.0|85.28|130.35|||Mixed Models Analysis|||||130.35|85.28|0.6771
72540674|NCT02625207|144610365|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio|75.74||||0.0331|TWO_SIDED|90.0|61.26|93.64|||Mixed Models Analysis|||||93.64|61.26|0.0331
72540675|NCT02625207|144610365|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio|71.84||||0.0104|TWO_SIDED|90.0|58.38|88.4|||Mixed Models Analysis|||||88.40|58.38|0.0104
72540676|NCT02625207|144610365|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio|71.82||||0.0104|TWO_SIDED|90.0|58.37|88.39|||Mixed Models Analysis|||||88.39|58.37|0.0104
72540677|NCT02625207|144610366|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio|99.62||||0.9713|TWO_SIDED|90.0|83.07|119.45|||Mixed Models Analysis|||||119.45|83.07|0.9713
72540678|NCT00802529|144610393|SUPERIORITY_OR_OTHER|||||||0.271||||||P-value for Drug x Time interaction.|ANOVA|Time: 2 degrees of freedom (Baseline vs 18-24 months) Drug: 2 degrees of freedom (Gentamicin vs steroid)||||||0.271
72575445|NCT01197755|144676860|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.4||||0.004|TWO_SIDED|95.0|1.33|4.45|||Regression, Logistic|Odds ratio and 95% confidence intervals are calculated using logistic regression with treatment and pooled country as factors|An odds ratio \>1 indicates a benefit towards fostamatinib.|Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||4.45|1.33|0.004
72627590|NCT00565409|144783931|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.98|||<|0.0001|TWO_SIDED|95.0|-1.2|-0.8|||ANCOVA|ANCOVA model: Change = Week 36 score + treatment + geographic region.||Week 56||-0.8|-1.2|<0.0001
72540679|NCT00802529|144610394|SUPERIORITY_OR_OTHER|||||||0.964||||||P-value for Drug x Time interaction.|ANOVA|Time: 6 degrees of freedom (Baseline, 1, 2, 6, 12, 18 and 24 months) Drug: 2 degrees of freedom (Gentamicin vs steroid)||||||0.964
72540680|NCT00802529|144610395|SUPERIORITY_OR_OTHER|||||||0.128||||||P-value for Drug x Time interaction.|ANOVA|Time: 5 degrees of freedom (Baseline, 1, 2, 6, 12 and 24 months) Drug: 2 degrees of freedom (Gentamicin vs steroid)||||||0.128
72540681|NCT00337129|144610407|SUPERIORITY_OR_OTHER||Response probability|0.05|||||TWO_SIDED|95.0|0.01|0.17|||two-stage binomial|||Null hypothesis: response probability \< 5%; alternative hypothesis: response probability \> 20%. A two-stage design was used. If no responses among the first 20 patients, the study would be terminated with the conclusion that E7389 is inactive. However, if at least one response was seen then an additional 20 patients would be accrued. Five or more responses out of 40 would be considered evidence that E7389 warranted further study. This design had a significance level of 5% and a power of 92%.||0.17|0.01|
72540682|NCT00563524|144610437|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5237|||||||ANCOVA|||Baseline: Analysis of covariance (ANCOVA) with pre-dose as the baseline covariate and treatment as a factor was used for the analysis.||||0.5237
72540683|NCT00563524|144610437|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8463|||||||ANCOVA|||Day 14: ANCOVA with pre-dose as the baseline covariate and treatment as a factor was used for the analysis.||||0.8463
72540684|NCT00563524|144610437|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4596|||||||ANCOVA|||Day 28: ANCOVA with pre-dose as the baseline covariate and treatment as a factor was used for the analysis.||||0.4596
72540685|NCT00563524|144610437|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6345|||||||ANCOVA|||Day 42: ANCOVA with pre-dose as the baseline covariate and treatment as a factor was used for the analysis.||||0.6345
72540686|NCT00563524|144610437|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6235|||||||ANCOVA|||Day 56: ANCOVA with pre-dose as the baseline covariate and treatment as a factor was used for the analysis.||||0.6235
72540687|NCT00563524|144610438|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3833|||||||ANCOVA|||Baseline: ANCOVA with pre-dose as the baseline covariate and treatment as a factor was used for the analysis.||||0.3833
72369234|NCT00611026|144248558|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.1||0.0794|TWO_SIDED|95.0|-0.2|0.0|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.|"Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type:~standard error of the mean."|Treatment difference Tolterodine ER vs placebo at Week 4.||0.0|-0.2|0.0794
72540688|NCT00563524|144610438|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4909|||||||ANCOVA|||Day 14: ANCOVA with pre-dose as the baseline covariate and treatment as a factor was used for the analysis.||||0.4909
72540689|NCT00563524|144610438|SUPERIORITY_OR_OTHER_LEGACY|||||||0.22|||||||ANCOVA|||Day 28: ANCOVA with pre-dose as the baseline covariate and treatment as a factor was used for the analysis.||||0.2200
72540690|NCT00563524|144610438|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4183|||||||ANCOVA|||Day 42: ANCOVA with pre-dose as the baseline covariate and treatment as a factor was used for the analysis.||||0.4183
72540691|NCT00563524|144610438|SUPERIORITY_OR_OTHER_LEGACY|||||||0.465|||||||ANCOVA|||Day 56: ANCOVA with pre-dose as the baseline covariate and treatment as a factor was used for the analysis.||||0.4650
72540692|NCT00563524|144610439|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7051|||||||ANCOVA|||Baseline: ANCOVA with pre-dose as the baseline covariate and treatment as a factor was used for the analysis.||||0.7051
72540693|NCT00563524|144610439|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1072|||||||ANCOVA|||Day 14: ANCOVA with pre-dose as the baseline covariate and treatment as a factor was used for the analysis.||||0.1072
72540694|NCT00563524|144610439|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002|||||||ANCOVA|||Day 28: ANCOVA with pre-dose as the baseline covariate and treatment as a factor was used for the analysis.||||0.0020
72540695|NCT00563524|144610439|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0079|||||||ANCOVA|||Day 42: ANCOVA with pre-dose as the baseline covariate and treatment as a factor was used for the analysis.||||0.0079
72540696|NCT00563524|144610439|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0308|||||||ANCOVA|||Day 56: ANCOVA with pre-dose as the baseline covariate and treatment as a factor was used for the analysis.||||0.0308
72540697|NCT00450177|144610486|OTHER|||||||0.03|||||||Chi-squared|||||||0.03
72540698|NCT02613416|144610495|OTHER|||||||0.026||||||The p value was calculated.|Blyth-Still Casella Confidence Interval|||The primary hypothesis for this early phase study was that at least 30% of women would experience a \>5% relative decrease in their breast density after 6 months of treatment with denosumab 120 mg subcutaneous dose once a month.||||0.026
72540699|NCT00763269|144610497|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
72575446|NCT01197755|144676860|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.5||||0.186|TWO_SIDED|95.0|0.82|2.79||Nominal p-value presented for Group B comparison. Formal statistical testing could not be carried out due to the predefined multiplicity procedure (primary variable comparison of Group B versus Group C was non-significant).|Regression, Logistic|Odds ratio and 95% confidence intervals are calculated using logistic regression with treatment and pooled country as factors|An odds ratio \>1 indicates a benefit towards fostamatinib.|Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||2.79|0.82|0.186
72575447|NCT01197755|144676861|SUPERIORITY_OR_OTHER|||||||0.729||||||Nominal p-value only. This was not included in the pre-defined multiplicity procedure. As this is a non-parametric test p-values alone are presented rather than an estimated treatment difference.|ANCOVA|This was performed on the ranks of the change from baseline, by pooled country, including a term for the ranks of the baseline score as covariate.||||||0.729
72540700|NCT00763269|144610498|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
72575448|NCT01197755|144676861|SUPERIORITY_OR_OTHER|||||||0.019||||||Nominal p-value only. This was not included in the pre-defined multiplicity procedure. As this is a non-parametric test p-values alone are presented rather than an estimated treatment difference.|ANCOVA|This was performed on the ranks of the change from baseline, by pooled country, including a term for the ranks of the baseline score as covariate.||||||0.019
72575449|NCT01197755|144676862|SUPERIORITY_OR_OTHER||Treatment difference|2.6||||0.009||95.0|0.65|4.56|||ANCOVA|Improvement from baseline, including terms for baseline as a continuous covariate and treatment and pooled country as factors.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||4.56|0.65|0.009
72575450|NCT01197755|144676862|SUPERIORITY_OR_OTHER||Treatment difference|1.53||||0.118|TWO_SIDED|95.0|-0.39|3.44|||ANCOVA|Improvement from baseline, including terms for baseline as a continuous covariate and treatment and pooled country as factors.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||3.44|-0.39|0.118
72575451|NCT01197755|144676863|SUPERIORITY_OR_OTHER||Treatment difference|0.67||||0.487||95.0|-1.23|2.58|||ANCOVA|Improvement from baseline, including terms for baseline as a continuous covariate and treatment and pooled country as factors.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||2.58|-1.23|0.487
72369235|NCT00611026|144248558|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.0||0.5906|TWO_SIDED|95.0|-0.1|0.1|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.|"Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type:~standard error of the mean."|Treatment difference fesoterodine vs Tolterodine ER at Week 4.||0.1|-0.1|0.5906
72369236|NCT00611026|144248558|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.14|STANDARD_ERROR_OF_MEAN|0.1||0.0134|TWO_SIDED|95.0|-0.3|0.0|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.|"Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type:~standard error of the mean."|Treatment difference fesoterodine vs placebo at Week 12.||-0.0|-0.3|0.0134
72540701|NCT00763269|144610499|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
72540702|NCT00763269|144610500|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
72540703|NCT02320838|144610508|OTHER||||||<|0.001||||||A priori threshold for statistical significance. p\<0.05|ANOVA|||||||<0.001
72540704|NCT02320838|144610509|OTHER|||||||0.04||||||A priori threshold for statistical significance. p\<0.05|ANOVA|||||||0.04
72540705|NCT02320838|144610510|OTHER|||||||0.9||||||A priori threshold for statistical significance. p\<0.05|ANOVA|||||||0.9
72540706|NCT02320838|144610511|OTHER|||||||0.001||||||A priori threshold for statistical significance. p\<0.05|ANOVA|||||||0.001
72540707|NCT02320838|144610512|OTHER|||||||0.003||||||A priori threshold for statistical significance. p\<0.05|t-test, 2 sided|||||||0.003
72540708|NCT02320838|144610513|OTHER|||||||0.023||||||A priori threshold for statistical significance. p\<0.05|Chi-squared|||||||0.023
72540709|NCT02320838|144610514|OTHER|||||||0.003||||||A priori threshold for statistical significance. p\<0,05|t-test, 2 sided|||||||0.003
72540710|NCT02320838|144610515|OTHER|||||||0.8||||||A priori threshold for statistical significance. p\<0.05|ANOVA|||||||0.8
72540711|NCT02320838|144610516|OTHER|||||||0.02||||||A priori threshold for statistical significance. p\<0.05|ANOVA|||||||0.02
72540712|NCT02320838|144610517|OTHER|||||||0.4||||||A priori threshold for statistical significance. p\<0.05|ANOVA|||||||0.4
72540713|NCT02320838|144610518|OTHER|||||||0.8|||||||ANOVA|||||||0.8
72540714|NCT02320838|144610519|OTHER|||||||1||||||A priori threshold for statistical significance. p\<0.05|ANOVA|||||||1.0
72627591|NCT00565409|144783931|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.86|||<|0.0001|TWO_SIDED|95.0|-1.1|-0.7|||ANCOVA|ANCOVA model: Change = Week 36 score + treatment + geographic region.||Week 64||-0.7|-1.1|<0.0001
72540715|NCT02320838|144610520|OTHER|||||||0.4||||||A priori threshold for statistical significance. p\<0.05|ANOVA|||||||0.4
72540716|NCT02320838|144610521|OTHER|||||||0.1||||||A priori threshold for statistical significance. p\<0.05|ANOVA|||||||0.1
72540717|NCT02320838|144610522|OTHER|||||||0.9||||||A priori threshold for statistical significance. p\<0.05|ANOVA|||||||0.9
72540718|NCT02320838|144610523|OTHER|||||||0.9||||||A priori threshold for statistical significance. p\<0.05|ANOVA|||||||0.9
72540719|NCT02320838|144610524|OTHER|||||||0.5||||||A priori threshold for statistical significance. p\<0.05|ANOVA|||||||0.5
72540720|NCT02320838|144610525|OTHER|||||||0.6||||||A priori threshold for statistical significance. p\<0.05|ANOVA|||||||0.6
72540721|NCT02320838|144610526|OTHER|||||||0.1||||||A priori threshold for statistical significance. p\<0.05|ANOVA|||||||0.1
72540722|NCT02320838|144610527|OTHER|||||||0.2||||||A priori threshold for statistical significance. p\<0.05|ANOVA|||||||0.2
72540723|NCT02320838|144610528|OTHER|||||||1||||||A priori threshold for statistical significance. p\<0.05|ANOVA|||||||1.0
72540724|NCT01398982|144610531|NON_INFERIORITY_OR_EQUIVALENCE|Based on our published prospective, nonrandomized study using TAP block in abdominally-based autologous tissue breast reconstruction, 40 patients per group would achieve 85% power to detect a 65% reduction in mean total opioid consumption between the control and study groups (significance level alpha = 0.05; using a two-sided Wilcoxon rank-sum test).||||||0.02|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.02
72540725|NCT03964220|144610546|OTHER||Hazard Ratio (HR)|0.65||||0.044|TWO_SIDED|95.0|0.427|0.99|||Regression, Cox|||The time to first exacerbation was analysis using Cox Proportional Hazards model with group status as the only independent variable assessing the risk of exacerbation across Tio and NonTio groups.||0.990|0.427|0.044
72540726|NCT03964220|144610547|OTHER||||||<|0.0001|||||||Negative binomial regression|||Analysis for the rate of exacerbation between Tio and NonTio groups within 6 months of follow-up.||||< 0.0001
72540727|NCT03964220|144610547|OTHER||||||<|0.0001|||||||Negative binomial regression|||Analysis for the rate of exacerbation between Tio and NonTio groups within 1 year of follow-up.||||< 0.0001
72540728|NCT00589693|144610574|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority will be established if the lower limit of the 2-sided 95% Confidence Interval (CI) of the difference in clinical cure rate (doripenem minus imipenem-cilastatin) is greater than 15%|Difference of 2 binomial proportions|-11.2|||||TWO_SIDED|95.0|-26.3|3.8|||Normal approximation of 2 proportions|||Null Hypothesis: The clinical cure rate of doripenem assessed at the EOT visit is more than 15% inferior to that of imipenem-cilastatin||3.8|-26.3|
72540729|NCT00589693|144610575|SUPERIORITY_OR_OTHER||Difference of 2 binomial proportions|-18.8|||||TWO_SIDED|95.0|-57.2|19.5|||Normal approximation of 2 proportions|||||19.5|-57.2|
72540730|NCT00589693|144610576|SUPERIORITY_OR_OTHER||Difference of 2 binomial proportions|-5.6|||||TWO_SIDED|95.0|-23.0|11.7|||Normal approximation of 2 proportions|||||11.7|-23.0|
72540731|NCT00589693|144610577|SUPERIORITY_OR_OTHER|||||||0.14|||||||Fisher Exact|||||||0.14
72540732|NCT00589693|144610578|SUPERIORITY_OR_OTHER||Difference of 2 binomial proportions|6.7|||||TWO_SIDED|95.0|-5.0|18.5|||Normal approximation of 2 proportions|||||18.5|-5.0|
72540733|NCT03231709|144610579|OTHER|||||||0.0141|||||||Mainland-Gart Test|||||||0.0141
72540734|NCT02609178|144610583|NON_INFERIORITY_OR_EQUIVALENCE|Using G\*power 3.1.7, setting α at 0.05, (1- β) at 0.8, the number of the subjects enrolled could reach the actual power as 0.8.||||||0.003||||||Alpha value was set at 0.05.|ANOVA|||||||0.003
72540735|NCT02609178|144610583|NON_INFERIORITY_OR_EQUIVALENCE|stated above in statistical analysis 1||||||0.366||||||Alpha value was set at 0.05.|Tukey's multiple comparison test|||||||0.366
72540736|NCT02609178|144610583|NON_INFERIORITY_OR_EQUIVALENCE|Stated above in statistical analysis 1.||||||0.002||||||Alpha value was set at 0.05.|Tukey's multiple comparison test|||||||0.002
72540737|NCT02609178|144610583|NON_INFERIORITY_OR_EQUIVALENCE|Stated above in statistical analysis 1.||||||0.054||||||Alpha value was set at 0.05.|Tukey's multiple comparison test|||||||0.054
72540738|NCT02609178|144610584|NON_INFERIORITY_OR_EQUIVALENCE|Using G\*power 3.1.7, setting α at 0.05, (1- β) at 0.8, the number of the subjects enrolled could reach the actual power as 0.8.||||||0.006||||||alpha value was set at 0.05|Kruskal-Wallis|||||||0.006
72540739|NCT02609178|144610584|NON_INFERIORITY_OR_EQUIVALENCE|Stated above in statistic analysis 1.||||||0.739||||||Alpha value was set at 0.05.|Wilcoxon (Mann-Whitney)|||||||0.739
72540740|NCT02609178|144610584|NON_INFERIORITY_OR_EQUIVALENCE|Stated above in statistical analysis 1.||||||0.03||||||Alpha value was set at 0.05.|Wilcoxon (Mann-Whitney)|||||||0.03
72627592|NCT00565409|144783931|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.07||||0.4868|TWO_SIDED|95.0|-0.1|0.3|||ANCOVA|ANCOVA model: Change = Week 36 score + treatment + geographic region.||Week 64||0.3|-0.1|0.4868
72540741|NCT02609178|144610584|NON_INFERIORITY_OR_EQUIVALENCE|Stated above in statistical analysis 1.||||||0.009||||||Alpha value was set at 0.05.|Wilcoxon (Mann-Whitney)|||||||0.009
72540742|NCT02609178|144610585|NON_INFERIORITY_OR_EQUIVALENCE|Using G\*power 3.1.7, setting α at 0.05, (1- β) at 0.8, the number of the subjects enrolled could reach the actual power as 0.8.||||||0.001||||||alpha value was set at 0.05|Kruskal-Wallis|||||||0.001
72540743|NCT02609178|144610585|NON_INFERIORITY_OR_EQUIVALENCE|Stated above in statistical analysis 1.||||||0.579||||||Alpha value was set at 0.05.|Wilcoxon (Mann-Whitney)|||||||0.579
72540744|NCT02609178|144610585|NON_INFERIORITY_OR_EQUIVALENCE|Stated above in statistical analysis 1.||||||0.001||||||Alpha value was set at 0.05.|Wilcoxon (Mann-Whitney)|||||||0.001
72540745|NCT02609178|144610585|NON_INFERIORITY_OR_EQUIVALENCE|Stated above in statistical analysis 1.||||||0.002||||||Alpha value was set at 0.05.|Wilcoxon (Mann-Whitney)|||||||0.002
72540746|NCT02609178|144610586|NON_INFERIORITY_OR_EQUIVALENCE|Using G\*power 3.1.7, setting α at 0.05, (1- β) at 0.8, the number of the subjects enrolled could reach the actual power as 0.8.||||||0.007||||||alpha value was set at 0.05|ANOVA|||||||0.007
72540747|NCT02609178|144610586|NON_INFERIORITY_OR_EQUIVALENCE|Stated above in statistical analysis 1.||||||0.308||||||Alpha value was set at 0.05.|Tukey's multiple comparison test|||||||0.308
72540748|NCT02609178|144610586|NON_INFERIORITY_OR_EQUIVALENCE|Stated above in statistical analysis 1.||||||0.005||||||Alpha value was set at 0.05.|Tukey's multiple comparison test|||||||0.005
72540749|NCT02609178|144610586|NON_INFERIORITY_OR_EQUIVALENCE|Stated above in statistical analysis 1.||||||0.141||||||Alpha value was set at 0.05.|Tukey's multiple comparison test|||||||0.141
72540750|NCT01128153|144610587|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.66|STANDARD_ERROR_OF_MEAN|0.099|<|0.0001|TWO_SIDED|95.0|-0.86|-0.47|||ANCOVA||Adjusted mean treatment difference from the ANCOVA model (Saxagliptin - Placebo)|||-0.47|-0.86|<0.0001
72540751|NCT01128153|144610588|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.74|STANDARD_ERROR_OF_MEAN|7.667||0.0301|TWO_SIDED|95.0|-31.85|-1.62|||ANCOVA||Adjusted mean treatment difference from the ANCOVA model (Saxagliptin - Placebo)|||-1.62|-31.85|0.0301
72540752|NCT01128153|144610589|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.93|STANDARD_ERROR_OF_MEAN|0.426||0.0301|TWO_SIDED|95.0|-1.77|-0.09|||ANCOVA||Adjusted mean treatment difference from the ANCOVA model (Saxagliptin - Placebo)|||-0.09|-1.77|0.0301
72540753|NCT01128153|144610590|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.9|STANDARD_ERROR_OF_MEAN|4.595||0.0868|TWO_SIDED|95.0|-16.96|1.15|||ANCOVA||Adjusted mean treatment difference from the ANCOVA model (Saxagliptin - Placebo)|||1.15|-16.96|0.0868
72540754|NCT01128153|144610591|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.44|STANDARD_ERROR_OF_MEAN|0.255||0.0868|TWO_SIDED|95.0|-0.94|0.06|||ANCOVA||Adjusted mean treatment difference from the ANCOVA model (Saxagliptin - Placebo)|||0.06|-0.94|0.0868
72540755|NCT01128153|144610592|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|9.006|||<|0.0001|TWO_SIDED|95.0|3.852|21.05|||ANCOVA||Estimated Odds Ratio from the logistic regression model (Saxa/Placebo)|||21.05|3.852|<0.0001
72540756|NCT01682512|144610594|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence for the change in DAS28 (ESR) was evaluated based on the two-sided 90% Confidence Interval (CI) for the treatment difference with respect to the mean change in the DAS28(ESR) score compared to baseline. Null hypothesis of non-equivalence was to be rejected if the 90% CI is fully contained within the interval of \[-0.5, 0.5\].|Adjusted mean difference|-0.4|||||TWO_SIDED|90.0|-0.83|-0.03||Model analyzed was: DAS28(ESR) change from Baseline at Week 24 = overall mean + treatment + DAS28(ESR) Baseline score + visit + visit by treatment interaction + baseline-by-visit interaction + random error.|Mixed Models Analysis|A restricted maximum likelihood (REML)-based Mixed-Effect Model Repeated Measure (MMRM) approach was used.|Adjusted mean difference was calculated as: BI 695500 - Rituxan®|||-0.03|-0.83|
72540757|NCT01682512|144610595|SUPERIORITY_OR_OTHER||Adjusted ratio of gMeans (%)|102.35|STANDARD_ERROR_OF_MEAN|107.7|||TWO_SIDED|90.0|90.5|115.76|||ANOVA|Analysis of variance (ANOVA) model on logarithmic scale: Ln(AUC0-tz)=overall mean+treatment effect+random error|Adjusted ratio of gMeans: BI 695500 versus Rituxan®; standard error is geometric standard error|The similarity of AUC(o- tz) was compared between treatment groups BI 695500 and Rituxan.||115.76|90.50|
72540758|NCT01682512|144610595|SUPERIORITY_OR_OTHER||Adjusted ratio of gMeans (%)|88.21|STANDARD_ERROR_OF_MEAN|107.5|||TWO_SIDED|90.0|78.24|99.46|||ANOVA|Analysis of variance (ANOVA) model on logarithmic scale: Ln(AUC0-tz)=overall mean+treatment effect+random error|Adjusted ratio of gMeans: BI 695500 versus MabThera®; standard error is geometric standard error|The similarity of AUC(o- tz) was compared between treatment groups BI 695500 and MabThera.||99.46|78.24|
72540759|NCT01682512|144610595|SUPERIORITY_OR_OTHER||Adjusted ratio of gMeans (%)|86.18|STANDARD_ERROR_OF_MEAN|107.449|||TWO_SIDED|90.0|76.5|97.09|||ANOVA|Analysis of variance (ANOVA) model on logarithmic scale: Ln(AUC0-tz)=overall mean+treatment effect+random error|Adjusted ratio of gMeans: Rituxan® versus MabThera®; standard error is geometric standard error|The similarity of AUC(o- tz) was compared between treatment groups Rituxan and MabThera.||97.09|76.50|
72540760|NCT01682512|144610596|SUPERIORITY_OR_OTHER||Adjusted ratio of gMeans (%)|102.46|STANDARD_ERROR_OF_MEAN|107.939|||TWO_SIDED|90.0|90.26|116.3|||ANOVA|Analysis of variance (ANOVA) model on logarithmic scale: Ln(AUC0-inf pred)=overall mean+treatment effect+random error|Adjusted ratio of gMeans: BI 695500 versus Rituxan®; standard error is geometric standard error|The similarity of AUC(o-inf pred) was compared between treatment groups BI 695500 and Rituxan.||116.30|90.26|
72540761|NCT01682512|144610596|SUPERIORITY_OR_OTHER||Adjusted ratio of gMeans (%)|86.0|STANDARD_ERROR_OF_MEAN|107.404|||TWO_SIDED|90.0|76.38|96.82|||ANOVA|Analysis of variance (ANOVA) model on logarithmic scale: Ln(AUC0-inf pred)=overall mean+treatment effect+random error|Adjusted ratio of gMeans: BI 695500 versus MabThera®; standard error is geometric standard error|The similarity of AUC(o-inf pred) was compared between treatment groups BI 695500 and MabThera.||96.82|76.38|
72540762|NCT01682512|144610596|SUPERIORITY_OR_OTHER||Adjusted ratio of gMeans (%)|83.93|STANDARD_ERROR_OF_MEAN|107.386|||TWO_SIDED|90.0|74.57|94.47|||ANOVA|Analysis of variance (ANOVA) model on logarithmic scale: Ln(AUC0-inf pred)=overall mean+treatment effect+random error|Adjusted ratio of gMeans: Rituxan® versus MabThera®; standard error is geometric standard error|The similarity of AUC(o-inf pred) was compared between treatment groups Rituxan and MabThera.||94.47|74.57|
72540763|NCT01682512|144610597|SUPERIORITY_OR_OTHER||Adjusted ratio of gMeans (%)|95.87|STANDARD_ERROR_OF_MEAN|106.608|||TWO_SIDED|90.0|86.21|106.62|||ANOVA|Analysis of variance (ANOVA) model on logarithmic scale: Ln(AUC0-336)=overall mean+treatment effect+random error|Adjusted ratio of gMeans: BI 695500 versus Rituxan®; standard error is geometric standard error|The similarity of AUC(0-336) was compared between treatment groups BI 695500 and Rituxan.||106.62|86.21|
72540764|NCT01682512|144610597|SUPERIORITY_OR_OTHER||Adjusted ratio of gMeans (%)|89.46|STANDARD_ERROR_OF_MEAN|106.775|||TWO_SIDED|90.0|80.23|99.74|||ANOVA|Analysis of variance (ANOVA) model on logarithmic scale: Ln(AUC0-336)=overall mean+treatment effect+random error|Adjusted ratio of gMeans: BI 695500 versus MabThera®; standard error is geometric standard error|The similarity of AUC(0-336) was compared between treatment groups BI 695500 and MabThera.||99.74|80.23|
72540765|NCT01682512|144610597|SUPERIORITY_OR_OTHER||Adjusted ratio of gMeans (%)|93.31|STANDARD_ERROR_OF_MEAN|105.7|||TWO_SIDED|90.0|85.11|102.29|||ANOVA|Analysis of variance (ANOVA) model on logarithmic scale: Ln(AUC0-336)=overall mean+treatment effect+random error|Adjusted ratio of gMeans: Rituxan® versus MabThera®; standard error is geometric standard error|The similarity of AUC(0-336) was compared between treatment groups Rituxan and MabThera.||102.29|85.11|
72540766|NCT01682512|144610598|SUPERIORITY_OR_OTHER||Adjusted ratio of gMeans (%)|93.97|STANDARD_ERROR_OF_MEAN|105.995|||TWO_SIDED|90.0|85.32|103.5|||ANOVA|Analysis of variance (ANOVA) model on logarithmic scale: Ln(Cmax)=overall mean+treatment effect+random error|Adjusted ratio of gMeans: BI 695500 versus Rituxan®; standard error is geometric standard error|The similarity of observed Cmax was compared between treatment groups BI 695500 and Rituxan.||103.50|85.32|
72540767|NCT01682512|144610598|SUPERIORITY_OR_OTHER||Adjusted ratio of gMeans (%)|89.3|STANDARD_ERROR_OF_MEAN|105.657|||TWO_SIDED|90.0|81.51|97.83|||ANOVA|Analysis of variance (ANOVA) model on logarithmic scale: Ln(Cmax)=overall mean+treatment effect+random error|Adjusted ratio of gMeans: BI 695500 versus MabThera®; standard error is geometric standard error|The similarity of observed Cmax was compared between treatment groups BI 695500 and MabThera.||97.83|81.51|
72540768|NCT01682512|144610598|SUPERIORITY_OR_OTHER||Adjusted ratio of gMeans (%)|95.02|STANDARD_ERROR_OF_MEAN|105.744|||TWO_SIDED|90.0|86.62|104.25|||ANOVA|Analysis of variance (ANOVA) model on logarithmic scale: Ln(Cmax)=overall mean+treatment effect+random error|Adjusted ratio of gMeans: Rituxan® versus MabThera®; standard error is geometric standard error|The similarity of observed Cmax was compared between treatment groups Rituxan and MabThera.||104.25|86.62|
72540769|NCT01682512|144610600|SUPERIORITY_OR_OTHER||Adjusted ratio of gMeans (%)|104.49|STANDARD_ERROR_OF_MEAN|108.044|||TWO_SIDED|90.0|91.92|118.78|||ANOVA|Analysis of variance (ANOVA) model on logarithmic scale: Ln(AUC0-inf, ppk)=overall mean+treatment effect+random error|Adjusted ratio of gMeans: BI 695500 versus Rituxan®; standard error is geometric standard error|The similarity of AUC(0-inf, ppk) was compared between treatment groups BI 695500 and Rituxan.||118.78|91.92|
72540770|NCT01682512|144610600|SUPERIORITY_OR_OTHER||Adjusted ratio of gMeans (%)|91.39|STANDARD_ERROR_OF_MEAN|107.253|||TWO_SIDED|90.0|81.38|102.64|||ANOVA|Analysis of variance (ANOVA) model on logarithmic scale: Ln(AUC0-inf, ppk)=overall mean+treatment effect+random error|Adjusted ratio of gMeans: BI 695500 versus MabThera®; standard error is geometric standard error|The similarity of AUC(0-inf, ppk) was compared between treatment groups BI 695500 and MabThera.||102.64|81.38|
72540771|NCT01682512|144610600|SUPERIORITY_OR_OTHER||Adjusted ratio of gMeans (%)|87.47|STANDARD_ERROR_OF_MEAN|107.896|||TWO_SIDED|90.0|77.12|99.21|||ANOVA|Analysis of variance (ANOVA) model on logarithmic scale: Ln(AUC0-inf, ppk)=overall mean+treatment effect+random error|Adjusted ratio of gMeans: Rituxan® versus MabThera®; standard error is geometric standard error|The similarity of AUC(0-inf, ppk) was compared between treatment groups Rituxan and MabThera.||99.21|77.12|
72540772|NCT00054275|144610606|SUPERIORITY_OR_OTHER||proportion of pts with partial response|0.39||||0.95|TWO_SIDED|95.0|0.23|0.58|||confidence interval for partial response|Confidence interval for partial response rate using Wilson's Method||||0.58|0.23|0.95
72540773|NCT02572427|144610612|SUPERIORITY_OR_OTHER_LEGACY|||||||0.039|TWO_SIDED||||||t-test, 2 sided|||||||0.039
72540774|NCT02572427|144610613|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|TWO_SIDED||||||t-test, 2 sided|||||||0.001
72540775|NCT00996918|144610615|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.3||||0.39|TWO_SIDED|95.0|-4.29|1.68|||Mixed Models Analysis|||"Change from base study baseline in ADAS-Cog score at Week 13.~Results are from a restricted maximum likelihood (REML)-based mixed model for repeated measures (MMRM) with change from base study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||1.68|-4.29|0.390
72540776|NCT00996918|144610615|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.8||||0.264|TWO_SIDED|95.0|-1.37|4.97|||Mixed Models Analysis|||"Change from base study baseline in ADAS-Cog score at Week 13.~Results are from a REML-based MMRM with change from base study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||4.97|-1.37|0.264
72540777|NCT00996918|144610615|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.51||||0.357|TWO_SIDED|95.0|-4.74|1.72|||Mixed Models Analysis|||"Change from base study baseline in ADAS-Cog score at Week 26.~Results are from a REML-based MMRM with change from base study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||1.72|-4.74|0.357
72540778|NCT00996918|144610615|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.04||||0.981|TWO_SIDED|95.0|-3.5|3.42|||Mixed Models Analysis|||"Change from base study baseline in ADAS-Cog score at Week 26.~Results are from a REML-based MMRM with change from base study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||3.42|-3.50|0.981
72540779|NCT00996918|144610615|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.95||||0.584|TWO_SIDED|95.0|-4.37|2.47|||Mixed Models Analysis|||"Change from base study baseline in ADAS-Cog score at Week 39.~Results are from a REML-based MMRM with change from base study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||2.47|-4.37|0.584
72540780|NCT00996918|144610615|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.58||||0.392|TWO_SIDED|95.0|-2.05|5.2|||Mixed Models Analysis|||"Change from base study baseline in ADAS-Cog score at Week 39.~Results are from a REML-based MMRM with change from base study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||5.20|-2.05|0.392
72540781|NCT00996918|144610615|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.05||||0.345|TWO_SIDED|95.0|-6.34|2.24|||Mixed Models Analysis|||"Change from base study baseline in ADAS-Cog score at Week 52.~Results are from a REML-based MMRM with change from base study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||2.24|-6.34|0.345
72540782|NCT00996918|144610615|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.22||||0.922|TWO_SIDED|95.0|-4.73|4.28|||Mixed Models Analysis|||"Change from base study baseline in ADAS-Cog score at Week 52.~Results are from a REML-based MMRM with change from base study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||4.28|-4.73|0.922
72540783|NCT00996918|144610615|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.44||||0.384|TWO_SIDED|95.0|-7.97|3.1|||Mixed Models Analysis|||"Change from base study baseline in ADAS-Cog score at Week 78.~Results are from a REML-based MMRM with change from base study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||3.10|-7.97|0.384
72540784|NCT00996918|144610615|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.15||||0.961|TWO_SIDED|95.0|-6.08|5.78|||Mixed Models Analysis|||"Change from base study baseline in ADAS-Cog score at Week 78.~Results are from a REML-based MMRM with change from base study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||5.78|-6.08|0.961
72540785|NCT00996918|144610616|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.22||||0.837|TWO_SIDED|95.0|-1.91|2.35|||Mixed Models Analysis|||"Change from extension study baseline in ADAS-Cog score at Week 13.~Results are from a REML based MMRM with change from extension study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||2.35|-1.91|0.837
72540786|NCT00996918|144610616|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.14||||0.064|TWO_SIDED|95.0|-0.13|4.41|||Mixed Models Analysis|||"Change from extension study baseline in ADAS-Cog score at Week 13.~Results are from a REML based MMRM with change from extension study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||4.41|-0.13|0.064
72540787|NCT00996918|144610616|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01||||0.99|TWO_SIDED|95.0|-2.32|2.35|||Mixed Models Analysis|||"Change from extension study baseline in ADAS-Cog score at Week 26.~Results are from a REML based MMRM with change from extension study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||2.35|-2.32|0.990
72540788|NCT00996918|144610616|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3||||0.817|TWO_SIDED|95.0|-2.22|2.82|||Mixed Models Analysis|||"Change from extension study baseline in ADAS-Cog score at Week 26.~Results are from a REML based MMRM with change from extension study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||2.82|-2.22|0.817
72540789|NCT00996918|144610616|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.5||||0.697|TWO_SIDED|95.0|-2.04|3.05|||Mixed Models Analysis|||"Change from extension study baseline in ADAS-Cog score at Week 39.~Results are from a REML based MMRM with change from extension study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||3.05|-2.04|0.697
72540790|NCT00996918|144610616|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.93||||0.158|TWO_SIDED|95.0|-0.76|4.63|||Mixed Models Analysis|||"Change from extension study baseline in ADAS-Cog score at Week 39.~Results are from a REML based MMRM with change from extension study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||4.63|-0.76|0.158
72575452|NCT01197755|144676863|SUPERIORITY_OR_OTHER||Treatment difference|0.62||||0.516|TWO_SIDED|95.0|-1.26|2.51|||ANCOVA|Improvement from baseline, including terms for baseline as a continuous covariate and treatment and pooled country as factors.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||2.51|-1.26|0.516
72575453|NCT00758680|144676876|SUPERIORITY_OR_OTHER||LS Mean Difference on Last Dosing Day|37.63||||0.015|TWO_SIDED|95.0|12.58|62.68|||Mixed Effect Model|||||62.68|12.58|0.015
72575454|NCT00758680|144676876|SUPERIORITY_OR_OTHER||LS Mean Difference on Last Dosing Day|92.3|||<|0.001|TWO_SIDED|95.0|67.56|117.04|||Mixed Effect Model|||||117.04|67.56|<0.001
72575455|NCT01094886|144676878|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2|STANDARD_DEVIATION|0.5||0.008|TWO_SIDED|95.0|-0.05|0.34|||t-test, 2 sided|||||0.34|-0.05|.008
72575456|NCT01094886|144676879|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.91|STANDARD_DEVIATION|-1.1||0.111|TWO_SIDED|95.0|-2.048|0.219|||t-test, 2 sided|||||0.219|-2.048|0.111
72575457|NCT01094886|144676880|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.21|STANDARD_DEVIATION|6.977||0.87|TWO_SIDED|95.0|-2.77|2.35|||t-test, 2 sided|||||2.35|-2.77|0.87
72575458|NCT01094886|144676881|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-35.13|STANDARD_DEVIATION|36.316|<|0.001|TWO_SIDED|95.0|-48.01|-22.26|||t-test, 2 sided|||||-22.26|-48.01|<0.001
72627593|NCT00565409|144783931|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.93|||<|0.0001|TWO_SIDED|95.0|-1.1|-0.7|||ANCOVA|ANCOVA model: Change = Week 36 score + treatment + geographic region.||Week 64||-0.7|-1.1|<0.0001
72409834|NCT01639001|144328157|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.056||||0.6172|TWO_SIDED|95.0|0.734|1.521||If the PFS and ORR endpoints were significant, OS was to be considered significant if 1-sided, log-rank test stratified for ECOG, ethnicity and metastases was \<= 0.02496.|1 sided stratified log-rank||Based on the Cox Proportional hazards model stratified by ECOG PS, ethnicity, and brain metastases. Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of crizotinib.|||1.521|0.734|0.6172
72409835|NCT01639001|144328158|SUPERIORITY_OR_OTHER_LEGACY||Treatment difference|8.906||||0.1204|TWO_SIDED|95.0|-2.275|20.086|||2-sided pearson chi-square test||Treatment Difference in DCR Rate (%)|The confidence interval for the treatment difference was based on normal distribution.||20.086|-2.275|0.1204
72409836|NCT01639001|144328162|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.348|||<|0.0001|TWO_SIDED|95.0|0.246|0.493|||1 sided unstratified log-rank||Based on the Cox Proportional hazards model.|||0.493|0.246|<0.0001
72540791|NCT00996918|144610616|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4||||0.829|TWO_SIDED|95.0|-4.06|3.26|||Mixed Models Analysis|||"Change from extension study baseline in ADAS-Cog score at Week 52.~Results are from a REML based MMRM with change from extension study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||3.26|-4.06|0.829
72575459|NCT01282723|144676882|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.47||||0.0093|TWO_SIDED|95.0|1.1|1.95|||Mixed Models Analysis|||"Estimation of Odds Ratio of True Positive Fraction between SureCALL® and TOCO~Null hypothesis: There is no difference between the True Positive Fraction of SureCALL® and of TOCO or the SureCALL® is significantly greater than TOCO.~Alternative hypothesis: There is a difference between the True Positive Fraction of SureCALL® and of TOCO and the TOCO is significantly greater than SureCALL®."||1.95|1.10|0.0093
72575460|NCT01282723|144676882|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.85||||0.3204|TWO_SIDED|95.0|0.61|1.17|||Mixed Models Analysis|||"Estimation of Odds Ratio of False Positive Fraction between SureCALL® and TOCO~Null hypothesis: There is no difference between the False Positive Fraction of SureCALL® and of TOCO or the SureCALL® is significantly less than TOCO.~Alternative hypothesis: There is a difference between the False Positive Fraction of SureCALL® and of TOCO and the TOCO is significantly less than SureCALL®."||1.17|0.61|0.3204
72575461|NCT01284621|144676958|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability. Ratio calculated as empa plus ramipril divided by empa alone|Geometric mean ratio|96.55|STANDARD_DEVIATION|7.1|||TWO_SIDED|90.0|93.05|100.18|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment.|Standard deviation is actually the geometric coefficient of variation (gCV)|||100.18|93.05|
72575462|NCT01284621|144676959|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability. Ratio calculated as empa plus ramipril divided by empa alone|Geometric mean ratio|104.47|STANDARD_DEVIATION|13.1|||TWO_SIDED|90.0|97.65|111.77|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment.|Standard deviation is actually the gCV|||111.77|97.65|
72575463|NCT01284621|144676960|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability. Ratio calculated as empa plus ramipril divided by ramipril alone|Geometric mean ratio|108.14|STANDARD_DEVIATION|14.0|||TWO_SIDED|90.0|100.51|116.35|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment.|Standard deviation is actually the gCV|||116.35|100.51|
72409837|NCT01639001|144328163|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.669||||0.127|TWO_SIDED|95.0|0.335|1.338|||1 sided unstratified log-rank||Based on the Cox Proportional hazards model.|||1.338|0.335|0.1270
72409838|NCT01639001|144328164|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.277|||<|0.0001|TWO_SIDED|95.0|0.186|0.412|||1 sided unstratified log-rank||Based on the Cox Proportional hazards model.|||0.412|0.186|<0.0001
72409839|NCT01639001|144328165|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.432|||<|0.0001|TWO_SIDED|95.0|0.307|0.61||2-sided Hochberg adjusted p-values|2 sided unstratified log rank||Based on the Cox Proportional hazards model.|||0.610|0.307|<0.0001
72409840|NCT01639001|144328166|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|7.451|||<|0.0001|TWO_SIDED|95.0|3.79|11.11|||Mixed Models Analysis|||Analysis presented for QLQ-C30 Global QoL. Estimated change from baseline was from a repeated measures mixed-effects model with an intercept term, treatment, visit day and baseline EORTC QLQ-C30 subscale score (intercept and visit day are included as random effects). P-values and confidence intervals are not adjusted for multiplicity.||11.11|3.79|<0.0001
72409841|NCT01639001|144328166|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|3.613||||0.014|TWO_SIDED|95.0|0.73|6.49|||Mixed Models Analysis|||Analysis presented for QLQ-C30 cognitive functioning. Estimated change from baseline was from a repeated measures mixed-effects model with an intercept term, treatment, visit day and baseline EORTC QLQ-C30 subscale score (intercept and visit day are included as random effects). P-values and confidence intervals are not adjusted for multiplicity.||6.49|0.73|0.0140
72409842|NCT01639001|144328166|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|1.652||||0.2427|TWO_SIDED|95.0|-1.12|4.42|||Mixed Models Analysis|||Analysis presented for QLQ-C30 emotional functioning. Estimated change from baseline was from a repeated measures mixed-effects model with an intercept term, treatment, visit day and baseline EORTC QLQ-C30 subscale score (intercept and visit day are included as random effects). P-values and confidence intervals are not adjusted for multiplicity.||4.42|-1.12|0.2427
72409843|NCT01639001|144328166|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|6.7267|||<|0.0001|TWO_SIDED|95.0|4.15|9.3|||Mixed Models Analysis|||Analysis presented for QLQ-C30 physical functioning. Estimated change from baseline was from a repeated measures mixed-effects model with an intercept term, treatment, visit day and baseline EORTC QLQ-C30 subscale score (intercept and visit day are included as random effects). P-values and confidence intervals are not adjusted for multiplicity.||9.30|4.15|<0.0001
72575464|NCT01284621|144676961|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability. Ratio calculated as empa plus ramipril divided by ramipril alone.|Geometric mean ratio|103.61|STANDARD_DEVIATION|28.0|||TWO_SIDED|90.0|89.73|119.64|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment.|Standard deviation is actually the gCV|||119.64|89.73|
72575465|NCT01284621|144676962|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability. Ratio calculated as empa plus ramipril divided by ramipril alone|Geometric mean ratio|98.67|STANDARD_DEVIATION|5.2|||TWO_SIDED|90.0|96.0|101.42|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment.|Standard deviation is actually the gCV|||101.42|96.00|
72540792|NCT00996918|144610616|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.12||||0.95|TWO_SIDED|95.0|-3.69|3.93|||Mixed Models Analysis|||"Change from extension study baseline in ADAS-Cog score at Week 52.~Results are from a REML based MMRM with change from extension study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||3.93|-3.69|0.950
72575466|NCT01284621|144676963|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability. Ratio calculated as empa plus ramipril divided by ramipril alone.|Geometric mean ratio|98.29|STANDARD_DEVIATION|11.3|||TWO_SIDED|90.0|92.67|104.25|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment.|Standard deviation is actually the gCV|||104.25|92.67|
72540793|NCT00996918|144610616|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.56||||0.816|TWO_SIDED|95.0|-5.35|4.23|||Mixed Models Analysis|||"Change from extension study baseline in ADAS-Cog score at Week 78.~Results are from a REML based MMRM with change from extension study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||4.23|-5.35|0.816
72540794|NCT00996918|144610616|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.82||||0.751|TWO_SIDED|95.0|-4.32|5.96|||Mixed Models Analysis|||"Change from extension study baseline in ADAS-Cog score at Week 78.~Results are from a REML based MMRM with change from extension study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||5.96|-4.32|0.751
72540795|NCT00996918|144610617|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.16||||0.967|TWO_SIDED|95.0|-7.22|7.53|||Mixed Models Analysis|||"Change from base study baseline in DAD score at Week 13.~Results are from a REML-based MMRM with change from base study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||7.53|-7.22|0.967
72540796|NCT00996918|144610617|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.13||||0.593|TWO_SIDED|95.0|-5.72|9.98|||Mixed Models Analysis|||"Change from base study baseline in DAD score at Week 13.~Results are from a REML-based MMRM with change from base study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||9.98|-5.72|0.593
72540797|NCT00996918|144610617|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.15||||0.968|TWO_SIDED|95.0|-7.32|7.62|||Mixed Models Analysis|||"Change from base study baseline in DAD score at Week 26.~Results are from a REML-based MMRM with change from base study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||7.62|-7.32|0.968
72540798|NCT00996918|144610617|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.92||||0.473|TWO_SIDED|95.0|-10.92|5.08|||Mixed Models Analysis|||"Change from base study baseline in DAD score at Week 26.~Results are from a REML-based MMRM with change from base study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||5.08|-10.92|0.473
72540799|NCT00996918|144610617|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.95||||0.63|TWO_SIDED|95.0|-9.91|6.02|||Mixed Models Analysis|||"Change from base study baseline in DAD score at Week 39.~Results are from a REML-based MMRM with change from base study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||6.02|-9.91|0.630
72540800|NCT00996918|144610617|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.53||||0.293|TWO_SIDED|95.0|-13.02|3.95|||Mixed Models Analysis|||"Change from base study baseline in DAD score at Week 39.~Results are from a REML-based MMRM with change from base study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||3.95|-13.02|0.293
72540801|NCT00996918|144610617|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.53||||0.733|TWO_SIDED|95.0|-7.28|10.33|||Mixed Models Analysis|||"Change from base study baseline in DAD score at Week 52.~Results are from a REML-based MMRM with change from base study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||10.33|-7.28|0.733
72540802|NCT00996918|144610617|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.81||||0.55|TWO_SIDED|95.0|-12.06|6.45|||Mixed Models Analysis|||"Change from base study baseline in DAD score at Week 52.~Results are from a REML-based MMRM with change from base study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||6.45|-12.06|0.550
72540803|NCT00996918|144610617|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.73||||0.902|TWO_SIDED|95.0|-11.04|12.5|||Mixed Models Analysis|||"Change from base study baseline in DAD score at Week 78.~Results are from a REML-based MMRM with change from base study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||12.50|-11.04|0.902
72575467|NCT02968849|144676989|OTHER||Hazard Ratio (HR)|1.02||||0.84|TWO_SIDED|95.0|0.81|1.3|||Log Rank|The hazard ratio was tested using a sex-stratified log rank test.|The hazard ratio was estimated using a sex-stratified Cox proportional hazards model. The vaccine group (ALVAC-HIV + subtype C gp120/MF59) represents the numerator and the placebo group represents the denominator.|||1.30|0.81|0.84
72369237|NCT00611026|144248558|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.08|STANDARD_ERROR_OF_MEAN|0.1||0.1759|TWO_SIDED|95.0|-0.2|0.0|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.|"Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type:~standard error of the mean."|Treatment difference Tolterodine ER vs placebo at Week 12.||0.0|-0.2|0.1759
72540804|NCT00996918|144610617|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.07||||0.43|TWO_SIDED|95.0|-17.75|7.61|||Mixed Models Analysis|||"Change from base study baseline in DAD score at Week 78.~Results are from a REML-based MMRM with change from base study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||7.61|-17.75|0.430
72540805|NCT00996918|144610618|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.03||||0.683|TWO_SIDED|95.0|-6.01|3.95|||Mixed Models Analysis|||"Change from extension study baseline in DAD score at Week 13.~Results are from a REML based MMRM with change from extension study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||3.95|-6.01|0.683
72540806|NCT00996918|144610618|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.69||||0.177|TWO_SIDED|95.0|-1.68|9.06|||Mixed Models Analysis|||"Change from extension study baseline in DAD score at Week 13.~Results are from a REML based MMRM with change from extension study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||9.06|-1.68|0.177
72540807|NCT00996918|144610618|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.89||||0.734|TWO_SIDED|95.0|-6.03|4.25|||Mixed Models Analysis|||"Change from extension study baseline in DAD score at Week 26.~Results are from a REML based MMRM with change from extension study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||4.25|-6.03|0.734
72540808|NCT00996918|144610618|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.5||||0.595|TWO_SIDED|95.0|-7.06|4.05|||Mixed Models Analysis|||"Change from extension study baseline in DAD score at Week 26.~Results are from a REML based MMRM with change from extension study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||4.05|-7.06|0.595
72540809|NCT00996918|144610618|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.35||||0.409|TWO_SIDED|95.0|-7.95|3.24|||Mixed Models Analysis|||"Change from extension study baseline in DAD score at Week 39.~Results are from a REML based MMRM with change from extension study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||3.24|-7.95|0.409
72540810|NCT00996918|144610618|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.74||||0.368|TWO_SIDED|95.0|-8.73|3.24|||Mixed Models Analysis|||"Change from extension study baseline in DAD score at Week 39.~Results are from a REML based MMRM with change from extension study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||3.24|-8.73|0.368
72540811|NCT00996918|144610618|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.44||||0.458|TWO_SIDED|95.0|-4.01|8.89|||Mixed Models Analysis|||"Change from extension study baseline in DAD score at Week 52.~Results are from a REML based MMRM with change from extension study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||8.89|-4.01|0.458
72540812|NCT00996918|144610618|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.04||||0.76|TWO_SIDED|95.0|-7.77|5.68|||Mixed Models Analysis|||"Change from extension study baseline in DAD score at Week 52.~Results are from a REML based MMRM with change from extension study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||5.68|-7.77|0.760
72540813|NCT00996918|144610618|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.09||||0.597|TWO_SIDED|95.0|-5.67|9.86|||Mixed Models Analysis|||"Change from extension study baseline in DAD score at Week 78.~Results are from a REML based MMRM with change from extension study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||9.86|-5.67|0.597
72540814|NCT00996918|144610618|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.87||||0.501|TWO_SIDED|95.0|-11.24|5.5|||Mixed Models Analysis|||"Change from extension study baseline in DAD score at Week 78.~Results are from a REML based MMRM with change from extension study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||5.50|-11.24|0.501
72575468|NCT02968849|144676989|OTHER||Hazard Ratio (HR)|1.03||||0.83|TWO_SIDED|95.0|0.81|1.31|||Wald||The hazard ratio was estimated using Nelson-Aalen cumulative hazard estimates. The vaccine group (ALVAC-HIV + subtype C gp120/MF59) represents the numerator and the placebo group represents the denominator..|||1.31|0.81|0.83
72575469|NCT02968849|144677000|OTHER||Hazard Ratio (HR)|1.05||||0.66|TWO_SIDED|95.0|0.85|1.28|||Log Rank|The hazard ratio was tested using a sex-stratified log rank test.|The hazard ratio was estimated using a sex-stratified Cox proportional hazards model. The vaccine group (ALVAC-HIV + subtype C gp120/MF59) represents the numerator and the placebo group represents the denominator.|||1.28|0.85|0.66
72627594|NCT00565409|144783931|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.05|||<|0.0001|TWO_SIDED|95.0|-1.3|-0.8|||ANCOVA|ANCOVA model: Change = Week 36 score + treatment + geographic region.||Week 72||-0.8|-1.3|<0.0001
72409844|NCT01639001|144328166|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|6.8109||||0.0003|TWO_SIDED|95.0|3.15|10.47|||Mixed Models Analysis|||Analysis presented for QLQ-C30 role functioning. Estimated change from baseline was from a repeated measures mixed-effects model with an intercept term, treatment, visit day and baseline EORTC QLQ-C30 subscale score (intercept and visit day are included as random effects). P-values and confidence intervals are not adjusted for multiplicity.||10.47|3.15|0.0003
72540815|NCT00996918|144610619|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.6||||0.183|TWO_SIDED|95.0|-8.91|1.71|||Mixed Models Analysis|||"Change from base study baseline in NPI score at Week 26.~Results are from a REML-based MMRM with change from base study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||1.71|-8.91|0.183
72540816|NCT00996918|144610619|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.29||||0.92|TWO_SIDED|95.0|-5.92|5.35|||Mixed Models Analysis|||"Change from base study baseline in NPI score at Week 26.~Results are from a REML-based MMRM with change from base study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||5.35|-5.92|0.920
72575470|NCT02968849|144677000|OTHER||Hazard Ratio (HR)|1.0||||0.98|TWO_SIDED|95.0|0.81|1.23|||Wald||The hazard ratio was estimated using Nelson-Aalen cumulative hazard estimates. The vaccine group (ALVAC-HIV + subtype C gp120/MF59) represents the numerator and the placebo group represents the denominator..|||1.23|0.81|0.98
72575471|NCT02968849|144677002|OTHER||Hazard Ratio (HR)|1.15||||0.39|TWO_SIDED|95.0|0.84|1.58|||Log Rank|The hazard ratio was tested using a sex-stratified log rank test.|The hazard ratio was estimated using a sex-stratified Cox proportional hazards model. The vaccine group (ALVAC-HIV + subtype C gp120/MF59) represents the numerator and the placebo group represents the denominator.|||1.58|0.84|0.39
72575472|NCT02968849|144677002|OTHER||Hazard Ratio (HR)|1.12||||0.5|TWO_SIDED|95.0|0.81|1.54|||Wald||The hazard ratio was estimated using Nelson-Aalen cumulative hazard estimates. The vaccine group (ALVAC-HIV + subtype C gp120/MF59) represents the numerator and the placebo group represents the denominator..|||1.54|0.81|0.50
72575473|NCT02968849|144677013|OTHER||Hazard Ratio (HR)|1.03||||0.82|TWO_SIDED|95.0|0.8|1.33|||Log Rank|The hazard ratio was tested using a sex-stratified log rank test.|The hazard ratio was estimated using a sex-stratified Cox proportional hazards model. The vaccine group (ALVAC-HIV + subtype C gp120/MF59) represents the numerator and the placebo group represents the denominator.|||1.33|0.80|0.82
72575474|NCT02968849|144677014|OTHER||Hazard Ratio (HR)|0.99||||0.98|TWO_SIDED|95.0|0.5|1.98|||Log Rank|The hazard ratio was tested using a sex-stratified log rank test.|The hazard ratio was estimated using a sex-stratified Cox proportional hazards model. The vaccine group (ALVAC-HIV + subtype C gp120/MF59) represents the numerator and the placebo group represents the denominator.|||1.98|0.50|0.98
72575475|NCT02968849|144677015|OTHER||Hazard Ratio (HR)|1.08||||0.6|TWO_SIDED|95.0|0.8|1.47|||Log Rank|The hazard ratio was tested using a sex-stratified log rank test.|The hazard ratio was estimated using a sex-stratified Cox proportional hazards model. The vaccine group (ALVAC-HIV + subtype C gp120/MF59) represents the numerator and the placebo group represents the denominator.|||1.47|0.80|0.60
72575476|NCT02968849|144677016|OTHER||Hazard Ratio (HR)|0.92||||0.71|TWO_SIDED|95.0|0.58|1.46|||Log Rank|The hazard ratio was tested using a sex-stratified log rank test.|The hazard ratio was estimated using a sex-stratified Cox proportional hazards model. The vaccine group (ALVAC-HIV + subtype C gp120/MF59) represents the numerator and the placebo group represents the denominator.|||1.46|0.58|0.71
72575477|NCT02203331|144677053|SUPERIORITY_OR_OTHER_LEGACY||Emax|0.1483|STANDARD_ERROR_OF_MEAN|0.2925||0.3875|||||||Contrast tests for dose-response model|||The analysis was performed by using MCP-Mod method using pre-defined candidate dose-response model.||||0.3875
72627595|NCT00565409|144783931|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.03||||0.7847|TWO_SIDED|95.0|-0.2|0.2|||ANCOVA|ANCOVA model: Change = Week 36 score + treatment + geographic region.||Week 72||0.2|-0.2|0.7847
72575478|NCT02203331|144677053|SUPERIORITY_OR_OTHER_LEGACY||Linear|0.2484|STANDARD_ERROR_OF_MEAN|0.2975||0.2676|||||||Contrast tests for dose-response model|||The analysis was performed by using MCP-Mod method using pre-defined candidate dose-response model.||||0.2676
72575479|NCT02203331|144677053|SUPERIORITY_OR_OTHER_LEGACY||Sigmoidal Emax 1|0.1995|STANDARD_ERROR_OF_MEAN|0.2922||0.3211|||||||Contrast tests for dose-response model|||The analysis was performed by using MCP-Mod method using pre-defined candidate dose-response model.||||0.3211
72575480|NCT02203331|144677053|SUPERIORITY_OR_OTHER_LEGACY||Sigmoidal Emax 2|0.3467|STANDARD_ERROR_OF_MEAN|0.2994||0.1721|||||||Contrast tests for dose-response model|||The analysis was performed by using MCP-Mod method using pre-defined candidate dose-response model.||||0.1721
72575481|NCT02203331|144677054|SUPERIORITY_OR_OTHER_LEGACY||Emax|0.2736|STANDARD_ERROR_OF_MEAN|0.2878||0.231|||||||Contrast tests for dose-response model|||The analysis was performed by using MCP-Mod method using pre-defined candidate dose-response model.||||0.231
72575482|NCT02203331|144677054|SUPERIORITY_OR_OTHER_LEGACY||Linear|0.3234|STANDARD_ERROR_OF_MEAN|0.2927||0.1865|||||||Contrast tests for dose-response model|||The analysis was performed by using MCP-Mod method using pre-defined candidate dose-response model.||||0.1865
72575483|NCT02203331|144677054|SUPERIORITY_OR_OTHER_LEGACY||Sigmoidal Emax 1|0.3081|STANDARD_ERROR_OF_MEAN|0.2875||0.1955|||||||Contrast tests for dose-response model|||The analysis was performed by using MCP-Mod method using pre-defined candidate dose-response model.||||0.1955
72575484|NCT02203331|144677054|SUPERIORITY_OR_OTHER_LEGACY||Sigmoidal Emax 2|0.3781|STANDARD_ERROR_OF_MEAN|0.2944||0.1416|||||||Contrast tests for dose-response model|||The analysis was performed by using MCP-Mod method using pre-defined candidate dose-response model.||||0.1416
72575485|NCT02203331|144677055|SUPERIORITY_OR_OTHER_LEGACY||Emax|0.0081|STANDARD_ERROR_OF_MEAN|0.2832||0.5794|||||||Contrast tests for dose-response model|||The analysis was performed by using MCP-Mod method using pre-defined candidate dose-response model.||||0.5794
72575486|NCT02203331|144677055|SUPERIORITY_OR_OTHER_LEGACY||Linear|0.1148|STANDARD_ERROR_OF_MEAN|0.288||0.4301|||||||Contrast tests for dose-response model|||The analysis was performed by using MCP-Mod method using pre-defined candidate dose-response model.||||0.4301
72627596|NCT00565409|144783931|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.02|||<|0.0001|TWO_SIDED|95.0|-1.2|-0.8|||ANCOVA|ANCOVA model: Change = Week 36 score + treatment + geographic region.||Week 72||-0.8|-1.2|<0.0001
72409845|NCT01639001|144328166|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|5.594||||0.014|TWO_SIDED|95.0|1.13|10.06|||Mixed Models Analysis|||Analysis presented for QLQ-C30 social functioning. Estimated change from baseline was from a repeated measures mixed-effects model with an intercept term, treatment, visit day and baseline EORTC QLQ-C30 subscale score (intercept and visit day are included as random effects). P-values and confidence intervals are not adjusted for multiplicity.||10.06|1.13|0.0140
72575487|NCT02203331|144677055|SUPERIORITY_OR_OTHER_LEGACY||Sigmoidal Emax 1|0.0401|STANDARD_ERROR_OF_MEAN|0.2829||0.5337|||||||Contrast tests for dose-response model|||The analysis was performed by using MCP-Mod method using pre-defined candidate dose-response model.||||0.5337
72575488|NCT02203331|144677055|SUPERIORITY_OR_OTHER_LEGACY||Sigmoidal Emax 2|0.1835|STANDARD_ERROR_OF_MEAN|0.2899||0.3396|||||||Contrast tests for dose-response model|||The analysis was performed by using MCP-Mod method using pre-defined candidate dose-response model.||||0.3396
72575489|NCT02091466|144677060|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||ANCOVA|||Analysis of covariance for repeated measures (ANCOVA), adjusted for baseline values, compared tympanic temperatures between the groups. Statistical significance was established at p \< 0.05, and the statistical analysis was performed using SPSS (Statistical Package for the Social Sciences) software version 20.||||<0.05
72575490|NCT05307510|144677090|SUPERIORITY|Statistical analysis is under powered. N is too low.||||||0.135||||||The threshold for statistical significance was p \< 0.6|t-test, 2 sided|||Pain at rest||||0.135
72575491|NCT05307510|144677090|SUPERIORITY|Statistical analysis is underpowered. N is too low||||||0.716||||||The threshold for statistical significance was p \< 0.6|t-test, 2 sided|||Pain at Night||||.716
72575492|NCT05307510|144677090|SUPERIORITY|Statistical Analysis underpowered. N is too small.||||||0.509||||||The threshold for statistical significance was p \< 0.6|t-test, 2 sided|||Pain in use||||.509
72575493|NCT05307510|144677091|SUPERIORITY|||||||1|||||||t-test, 2 sided|||||||1
72575494|NCT05307510|144677092|SUPERIORITY|Statistical analysis is underpowered. N is too low.||||||0.635||||||The threshold for statistical significance was p \< 0.6|t-test, 2 sided|||Palmar abduction of surgical hand||||.635
72575495|NCT05307510|144677092|SUPERIORITY|Statistical analysis is underpowered. N is too low.|Mean Difference (Net)|-3.1||||0.521|TWO_SIDED|95.0|-13.6|7.4|||t-test, 2 sided|||Radial Abduction Surgical Hand||7.4|-13.6|.521
72575496|NCT05307510|144677093|SUPERIORITY|Statistical analysis is underpowered. N is too low.|Mean Difference (Net)|7.42||||0.495|TWO_SIDED|95.0|-16.16|32.0|||t-test, 2 sided|||||32.0|-16.16|.495
72575497|NCT05307510|144677094|SUPERIORITY|Statistical analysis is underpowered. N is too low.||||||0.953||||||The threshold for statistical significance was p \< 0.6|t-test, 2 sided|||Buttoning Buttons||||.953
72627597|NCT00565409|144783931|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.02|||<|0.0001|TWO_SIDED|95.0|-1.2|-0.8|||ANCOVA|ANCOVA model: Change = Week 36 score + treatment + geographic region.||Week 80||-0.8|-1.2|<0.0001
72627598|NCT00565409|144783931|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.981|TWO_SIDED|95.0|-0.2|0.2|||ANCOVA|ANCOVA model: Change = Week 36 score + treatment + geographic region.||Week 80||0.2|-0.2|0.9810
72575498|NCT05307510|144677094|SUPERIORITY|Statistical analysis is underpowered. N is too low.||||||0.947||||||The threshold for statistical significance was p \< 0.6|t-test, 2 sided|||Lacing and tying a shoe||||.947
72575499|NCT05307510|144677094|SUPERIORITY|Statistical analysis is underpowered. N is too low.||||||0.828||||||The threshold for statistical significance was p \< 0.6|t-test, 2 sided|||Opening and closing safety pins||||.828
72575500|NCT05307510|144677094|SUPERIORITY|Statistical analysis is underpowered. N is too low.||||||0.169||||||The threshold for statistical significance was p \< 0.6|t-test, 2 sided|||Managing coins||||.169
72575501|NCT05307510|144677095|SUPERIORITY|Statistical analysis underpowered. N too small.||||||0.917||||||The threshold for statistical significance was p \< 0.6|t-test, 2 sided|||||||.917
72575502|NCT05307510|144677095|SUPERIORITY|Statistical analysis is underpowered. N is too small||||||0.837||||||The threshold for statistical significance was p \< 0.6|t-test, 2 sided|||||||.837
72575503|NCT02784444|144677097|SUPERIORITY||Odds Ratio (OR)|0.89||||0.747|TWO_SIDED|95.0|0.44|1.81||Statistical testing was two-sided using a significance (alpha) level of 0.05. No adjustment for multiple comparisons.|Regression, Logistic|Models are adjusted for presence of diabetes mellitus, baseline fibrosis F1 versus F2/F3, and baseline NAS (0-8).||The null hypothesis is that there is no difference in response rates between the MSDC-0602K dose and placebo.||1.81|0.44|0.747
72575504|NCT02784444|144677097|SUPERIORITY||Odds Ratio (OR)|1.22||||0.575|TWO_SIDED|95.0|0.6|2.48||Statistical testing was two-sided using a significance (alpha) level of 0.05. No adjustment for multiple comparisons.|Regression, Logistic|Models are adjusted for presence of diabetes mellitus, baseline fibrosis F1 versus F2/F3, and baseline NAS (0-8).||The null hypothesis is that there is no difference in response rates between the MSDC-0602K dose and placebo.||2.48|0.60|0.575
72575505|NCT02784444|144677097|SUPERIORITY||Odds Ratio (OR)|1.64||||0.158|TWO_SIDED|95.0|0.83|3.27||Statistical testing was two-sided using a significance (alpha) level of 0.05. No adjustment for multiple comparisons.|Regression, Logistic|Models are adjusted for presence of diabetes mellitus, baseline fibrosis F1 versus F2/F3, and baseline NAS (0-8).||The null hypothesis is that there is no difference in response rates between the MSDC-0602K dose and placebo.||3.27|0.83|0.158
72575506|NCT02784444|144677098|SUPERIORITY||Odds Ratio (OR)|1.09||||0.828|TWO_SIDED|95.0|0.49|2.42||Statistical testing was two-sided using a significance (alpha) level of 0.05. No adjustment for multiple comparisons.|Regression, Logistic|Models are adjusted for presence of diabetes mellitus, baseline fibrosis F1 versus F2/F3, and baseline NAS (0-8).||The null hypothesis is that there is no difference in response rates between the MSDC-0602K dose and placebo.||2.42|0.49|0.828
72575507|NCT02784444|144677098|SUPERIORITY||Odds Ratio (OR)|1.5||||0.299|TWO_SIDED|95.0|0.7|3.21||Statistical testing was two-sided using a significance (alpha) level of 0.05. No adjustment for multiple comparisons.|Regression, Logistic|Models are adjusted for presence of diabetes mellitus, baseline fibrosis F1 versus F2/F3, and baseline NAS (0-8).||The null hypothesis is that there is no difference in response rates between the MSDC-0602K dose and placebo.||3.21|0.70|0.299
72627599|NCT00565409|144783931|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.02|||<|0.0001|TWO_SIDED|95.0|-1.2|-0.8|||ANCOVA|ANCOVA model: Change = Week 36 score + treatment + geographic region.||Week 80||-0.8|-1.2|<0.0001
72627600|NCT00565409|144783931|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.04|||<|0.0001|TWO_SIDED|95.0|-1.3|-0.8|||ANCOVA|ANCOVA model: Change = Week 36 score + treatment + geographic region.||Week 88||-0.8|-1.3|<0.0001
72540817|NCT00996918|144610619|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.99||||0.133|TWO_SIDED|95.0|-11.52|1.53|||Mixed Models Analysis|||"Change from base study baseline in NPI score at Week 52.~Results are from a REML-based MMRM with change from base study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||1.53|-11.52|0.133
72540818|NCT00996918|144610619|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.34||||0.505|TWO_SIDED|95.0|-4.55|9.22|||Mixed Models Analysis|||"Change from base study baseline in NPI score at Week 52.~Results are from a REML-based MMRM with change from base study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||9.22|-4.55|0.505
72540819|NCT00996918|144610619|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.86||||0.003|TWO_SIDED|95.0|-21.46|-4.25|||Mixed Models Analysis|||"Change from base study baseline in NPI score at Week 78.~Results are from a REML-based MMRM with change from base study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||-4.25|-21.46|0.003
72540820|NCT00996918|144610619|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.47||||0.76|TWO_SIDED|95.0|-7.95|10.88|||Mixed Models Analysis|||"Change from base study baseline in NPI score at Week 78.~Results are from a REML-based MMRM with change from base study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||10.88|-7.95|0.760
72540821|NCT00996918|144610620|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.08||||0.373|TWO_SIDED|95.0|-6.68|2.52|||Mixed Models Analysis|||"Change from extension study baseline in NPI score at Week 26.~Results are from a REML based MMRM with change from extension study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||2.52|-6.68|0.373
72540822|NCT00996918|144610620|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.03||||0.677|TWO_SIDED|95.0|-5.92|3.86|||Mixed Models Analysis|||"Change from extension study baseline in NPI score at Week 26.~Results are from a REML based MMRM with change from extension study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||3.86|-5.92|0.677
72540823|NCT00996918|144610620|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.4||||0.28|TWO_SIDED|95.0|-9.61|2.8|||Mixed Models Analysis|||"Change from extension study baseline in NPI score at Week 52.~Results are from a REML based MMRM with change from extension study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||2.80|-9.61|0.280
72575508|NCT02784444|144677098|SUPERIORITY||Odds Ratio (OR)|1.82||||0.116|TWO_SIDED|95.0|0.86|3.82||Statistical testing was two-sided using a significance (alpha) level of 0.05. No adjustment for multiple comparisons.|Regression, Logistic|Models are adjusted for presence of diabetes mellitus, baseline fibrosis F1 versus F2/F3, and baseline NAS (0-8).||The null hypothesis is that there is no difference in response rates between the MSDC-0602K dose and placebo.||3.82|0.86|0.116
72575509|NCT02784444|144677099|SUPERIORITY||Odds Ratio (OR)|1.19||||0.657|TWO_SIDED|95.0|0.55|2.55||Statistical testing was two-sided using a significance (alpha) level of 0.05. No adjustment for multiple comparisons.|Regression, Logistic|Models are adjusted for presence of diabetes mellitus, baseline fibrosis F1 versus F2/F3, and baseline NAS (0-8).||The null hypothesis is that there is no difference in response rates between the MSDC-0602K dose and placebo.||2.55|0.55|0.657
72575510|NCT02784444|144677099|SUPERIORITY||Odds Ratio (OR)|1.45||||0.332|TWO_SIDED|95.0|0.69|3.06||Statistical testing was two-sided using a significance (alpha) level of 0.05. No adjustment for multiple comparisons.|Regression, Logistic|Models are adjusted for presence of diabetes mellitus, baseline fibrosis F1 versus F2/F3, and baseline NAS (0-8).||The null hypothesis is that there is no difference in response rates between the MSDC-0602K dose and placebo.||3.06|0.69|0.332
72627601|NCT00565409|144783931|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.3562|TWO_SIDED|95.0|-0.3|0.1|||ANCOVA|ANCOVA model: Change = Week 36 score + treatment + geographic region.||Week 88||0.1|-0.3|0.3562
72627602|NCT00565409|144783931|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.94|||<|0.0001|TWO_SIDED|95.0|-1.2|-0.7|||ANCOVA|ANCOVA model: Change = Week 36 score + treatment + geographic region.||Week 88||-0.7|-1.2|<0.0001
72627603|NCT00565409|144783932|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Week 88 censored data was censored at 372 days.|Log Rank|||Imputation of failure defined as participants who did not reach the endpoint and discontinued due to lack of efficacy, with reason of unsatisfactory response-efficacy, adverse event, other or protocol violation were set to an event at time of discontinuation.||||<0.0001
72575511|NCT02784444|144677099|SUPERIORITY||Odds Ratio (OR)|1.51||||0.27|TWO_SIDED|95.0|0.72|3.16||Statistical testing was two-sided using a significance (alpha) level of 0.05. No adjustment for multiple comparisons.|Regression, Logistic|Models are adjusted for presence of diabetes mellitus, baseline fibrosis F1 versus F2/F3, and baseline NAS (0-8).||The null hypothesis is that there is no difference in response rates between the MSDC-0602K dose and placebo.||3.16|0.72|0.270
72575512|NCT02784444|144677100|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.392|TWO_SIDED|95.0|-0.7|0.3||Statistical testing was two-sided using a significance (alpha) level of 0.05. No adjustment for multiple comparisons.|ANCOVA|Model adjusted by age, sex, presence of diabetes mellitus, Vitamin E ≥ 400 IU, baseline fibrosis F1 versus F2/F3, and baseline NAS (0-8).||The null hypothesis is that there is no difference in changes between the MSDC-0602K dose and placebo.||0.3|-0.7|0.392
72627604|NCT00565409|144783932|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Week 88 censored data was censored at 372 days.|Log Rank|||Imputation of failure defined as participants who did not reach the endpoint and discontinued due to lack of efficacy, with reason of unsatisfactory response-efficacy, adverse event, other or protocol violation were set to an event at time of discontinuation.||||<0.0001
72540824|NCT00996918|144610620|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.21||||0.95|TWO_SIDED|95.0|-6.34|6.76|||Mixed Models Analysis|||"Change from extension study baseline in NPI score at Week 52.~Results are from a REML based MMRM with change from extension study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||6.76|-6.34|0.950
72540825|NCT00996918|144610620|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.06||||0.13|TWO_SIDED|95.0|-23.16|3.05|||Mixed Models Analysis|||"Change from extension study baseline in NPI score at Week 78.~Results are from a REML based MMRM with change from extension study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||3.05|-23.16|0.130
72540826|NCT00996918|144610620|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.48||||0.732|TWO_SIDED|95.0|-11.97|16.94|||Mixed Models Analysis|||"Change from extension study baseline in NPI score at Week 78.~Results are from a REML based MMRM with change from extension study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||16.94|-11.97|0.732
72540827|NCT00996918|144610621|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.05||||0.938|TWO_SIDED|95.0|-1.12|1.21|||Mixed Models Analysis|||"Change from base study baseline in MMSE score at Week 6.~Results are from a REML-based MMRM with change from base study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||1.21|-1.12|0.938
72540828|NCT00996918|144610621|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2||||0.753|TWO_SIDED|95.0|-1.43|1.04|||Mixed Models Analysis|||"Change from base study baseline in MMSE score at Week 6.~Results are from a REML-based MMRM with change from base study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||1.04|-1.43|0.753
72540829|NCT00996918|144610621|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.15||||0.809|TWO_SIDED|95.0|-1.04|1.33|||Mixed Models Analysis|||"Change from base study baseline in MMSE score at Week 19.~Results are from a REML-based MMRM with change from base study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||1.33|-1.04|0.809
72540830|NCT00996918|144610621|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.52||||0.421|TWO_SIDED|95.0|-1.8|0.75|||Mixed Models Analysis|||"Change from base study baseline in MMSE score at Week 19.~Results are from a REML-based MMRM with change from base study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||0.75|-1.80|0.421
72540831|NCT00996918|144610621|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.39||||0.535|TWO_SIDED|95.0|-0.85|1.63|||Mixed Models Analysis|||"Change from base study baseline in MMSE score at Week 32.~Results are from a REML-based MMRM with change from base study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||1.63|-0.85|0.535
72540832|NCT00996918|144610621|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.52||||0.445|TWO_SIDED|95.0|-0.82|1.86|||Mixed Models Analysis|||"Change from base study baseline in MMSE score at Week 32.~Results are from a REML-based MMRM with change from base study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||1.86|-0.82|0.445
72369238|NCT00611026|144248558|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.06|STANDARD_ERROR_OF_MEAN|0.0||0.1661|TWO_SIDED|95.0|-0.2|0.0|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.|"Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type:~standard error of the mean."|Treatment difference fesoterodine vs Tolterodine ER at Week 12.||0.0|-0.2|0.1661
72369239|NCT00611026|144248559|SUPERIORITY_OR_OTHER|||||||0.0021|TWO_SIDED|||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with terms for country and treatment and ranked baseline value as a covariate.||Treatment difference fesoterodine vs placebo at Week 4.||||0.0021
72369240|NCT00611026|144248559|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED|||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with terms for country and treatment and ranked baseline value as a covariate.||Treatment difference fesoterodine vs placebo at Week 12.||||0.0200
72369241|NCT00611026|144248560|SUPERIORITY_OR_OTHER|||||||0.0006|TWO_SIDED||||||Van Elteren's Test|P-value based on Van Elteren's Test (a stratified Wilcoxon-Mann Whitney test) adjusted by baseline UUI quartile.||"Treatment difference fesoterodine vs placebo at Week 1. Winsorized means (5% of the tails were censored, ie, replaced with the value at the 5th and 95th percentile, respectively).~If normality assumptions were severely violated (proportion of non normal observations \> 5%) a non-parametric analysis was to be conducted using Van Elteren's test stratified by baseline quartile of the diary variable analyzed."||||0.0006
72369242|NCT00611026|144248560|SUPERIORITY_OR_OTHER|||||||0.0202|TWO_SIDED||||||Van Elteren's Test|P-value based on Van Elteren's Test (a stratified Wilcoxon-Mann Whitney test) adjusted by baseline UUI quartile.||Treatment difference Tolterodine ER vs placebo at Week 1. Winsorized means (5% of the tails were censored, ie, replaced with the value at the 5th and 95th percentile, respectively).||||0.0202
72540833|NCT00996918|144610621|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.73||||0.309|TWO_SIDED|95.0|-0.67|2.12|||Mixed Models Analysis|||"Change from base study baseline in MMSE score at Week 45.~Results are from a REML-based MMRM with change from base study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||2.12|-0.67|0.309
72540834|NCT00996918|144610621|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.12||||0.872|TWO_SIDED|95.0|-1.34|1.57|||Mixed Models Analysis|||"Change from base study baseline in MMSE score at Week 45.~Results are from a REML-based MMRM with change from base study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||1.57|-1.34|0.872
72540835|NCT00996918|144610621|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.52||||0.004|TWO_SIDED|95.0|0.79|4.26|||Mixed Models Analysis|||"Change from base study baseline in MMSE score at Week 78.~Results are from a REML-based MMRM with change from base study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||4.26|0.79|0.004
72540836|NCT00996918|144610621|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.09||||0.026|TWO_SIDED|95.0|0.25|3.93|||Mixed Models Analysis|||"Change from base study baseline in MMSE score at Week 78.~Results are from a REML-based MMRM with change from base study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||3.93|0.25|0.026
72540837|NCT00996918|144610622|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.4||||0.504|TWO_SIDED|95.0|-0.77|1.57|||Mixed Models Analysis|||"Change from extension study baseline in MMSE score at Week 6.~Results are from a REML based MMRM with change from extension study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||1.57|-0.77|0.504
72540838|NCT00996918|144610622|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.34||||0.592|TWO_SIDED|95.0|-1.58|0.9|||Mixed Models Analysis|||"Change from extension study baseline in MMSE score at Week 6.~Results are from a REML based MMRM with change from extension study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||0.90|-1.58|0.592
72540839|NCT00996918|144610622|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.47||||0.441|TWO_SIDED|95.0|-0.72|1.65|||Mixed Models Analysis|||"Change from extension study baseline in MMSE score at Week 19.~Results are from a REML based MMRM with change from extension study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||1.65|-0.72|0.441
72540840|NCT00996918|144610622|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.69||||0.288|TWO_SIDED|95.0|-1.97|0.59|||Mixed Models Analysis|||"Change from extension study baseline in MMSE score at Week 19.~Results are from a REML based MMRM with change from extension study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||0.59|-1.97|0.288
72540841|NCT00996918|144610622|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.66||||0.303|TWO_SIDED|95.0|-0.59|1.9|||Mixed Models Analysis|||"Change from extension study baseline in MMSE score at Week 32.~Results are from a REML based MMRM with change from extension study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||1.90|-0.59|0.303
72540842|NCT00996918|144610622|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.25||||0.713|TWO_SIDED|95.0|-1.09|1.6|||Mixed Models Analysis|||"Change from extension study baseline in MMSE score at Week 32.~Results are from a REML based MMRM with change from extension study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||1.60|-1.09|0.713
72540843|NCT00996918|144610622|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.93||||0.198|TWO_SIDED|95.0|-0.49|2.34|||Mixed Models Analysis|||"Change from extension study baseline in MMSE score at Week 45.~Results are from a REML based MMRM with change from extension study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||2.34|-0.49|0.198
72540844|NCT00996918|144610622|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.23||||0.756|TWO_SIDED|95.0|-1.7|1.24|||Mixed Models Analysis|||"Change from extension study baseline in MMSE score at Week 45.~Results are from a REML based MMRM with change from extension study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||1.24|-1.70|0.756
72540845|NCT00996918|144610622|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.45||||0.006|TWO_SIDED|95.0|0.69|4.22|||Mixed Models Analysis|||"Change from extension study baseline in MMSE score at Week 78.~Results are from a REML based MMRM with change from extension study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||4.22|0.69|0.006
72627605|NCT00565409|144783932|SUPERIORITY_OR_OTHER|||||||0.8622|TWO_SIDED|||||Week 88 censored data was censored at 372 days.|Log Rank|||Imputation of failure defined as participants who did not reach the endpoint and discontinued due to lack of efficacy, with reason of unsatisfactory response-efficacy, adverse event, other or protocol violation were set to an event at time of discontinuation.||||0.8622
72540846|NCT00996918|144610622|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.75||||0.066|TWO_SIDED|95.0|-0.12|3.62|||Mixed Models Analysis|||"Change from extension study baseline in MMSE score at Week 78.~Results are from a REML based MMRM with change from extension study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||3.62|-0.12|0.066
72540847|NCT00854607|144610648|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.28||||0.166|TWO_SIDED|90.0|-0.2|0.77||One-Sided P-value|t-test, 1 sided|||Mean Difference between Non-Responders and Responders||0.77|-0.20|0.166
72540848|NCT00854607|144610649|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.17||||0.269|TWO_SIDED|90.0|-0.65|0.3||One-Sided P-value|t-test, 1 sided|||Mean Difference between Non-Responders and Responders||0.30|-0.65|0.269
72540849|NCT00854607|144610650|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.19||||0.101|TWO_SIDED|90.0|-0.06|0.44||One-Sided P-Value|t-test, 1 sided|||Mean Difference between Non-Responders and Responders||0.44|-0.06|0.101
72540850|NCT00854607|144610651|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.03||||0.457|TWO_SIDED|90.0|-0.42|0.47||One-Sided P-Value|t-test, 1 sided|||Mean Difference Between Non-Responders and Responders||0.47|-0.42|0.457
72540851|NCT00854607|144610652|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.32||||0.168|TWO_SIDED|90.0|-0.87|0.23||One-Sided P-Value|t-test, 1 sided|||Mean Difference between Non-Responders and Responders||0.23|-0.87|0.168
72540852|NCT00854607|144610653|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.19||||0.127|TWO_SIDED|90.0|-0.09|0.46||One-Sided P-Value|t-test, 1 sided|||Mean Difference between Non-Responders and Responders||0.46|-0.09|0.127
72540853|NCT00854607|144610654|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.47||||0.054|TWO_SIDED|90.0|-0.01|0.96||One-Sided P-Value|t-test, 1 sided|||Mean Difference between Non-Responders and Responders||0.96|-0.01|0.054
72540854|NCT00854607|144610655|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.21||||0.285|TWO_SIDED|90.0|-0.41|0.83||One-Sided P-Value|t-test, 1 sided|||Mean Difference between Non-Responders and Responders||0.83|-0.41|0.285
72540855|NCT00854607|144610656|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.41||||0.159|TWO_SIDED|90.0|-0.27|1.08||One-Sided P-Value|t-test, 1 sided|||Mean Difference between Non-Responders and Responders||1.08|-0.27|0.159
72540856|NCT00854607|144610657|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.15||||0.071|TWO_SIDED|90.0|-0.02|0.32||One-Sided P-Value|t-test, 1 sided|||Mean Difference between Non-Responders and Responders||0.32|-0.02|0.071
72540857|NCT00854607|144610658|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.17||||0.078|TWO_SIDED|90.0|-0.03|0.38||One-Sided P-Value|t-test, 1 sided|||Mean Difference between Non-Responders and Responders||0.38|-0.03|0.078
72540858|NCT00854607|144610659|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.39||||0.109|TWO_SIDED|90.0|-0.13|0.91||One-Sided P-Value|t-test, 1 sided|||Mean Difference between Non-Responders and Responders||0.91|-0.13|0.109
72627606|NCT00565409|144783933|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Week 88 censored data was censored at 372 days.|Log Rank|||||||<0.0001
72627607|NCT00565409|144783933|SUPERIORITY_OR_OTHER|||||||0.9841|TWO_SIDED|||||Week 88 censored data was censored at 372 days.|Log Rank|||||||0.9841
72540859|NCT00854607|144610660|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.65||||0.03|TWO_SIDED|90.0|0.09|1.22||One-Sided P-Value|t-test, 1 sided|||Mean Difference between Non-Responders and Responders||1.22|0.09|0.030
72540860|NCT00854607|144610661|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.16||||0.293|TWO_SIDED|90.0|-0.63|0.32||One-Sided P-value|t-test, 1 sided|||Mean Difference between Non-Responders and Responders||0.32|-0.63|0.293
72540861|NCT00854607|144610662|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.27||||0.213|TWO_SIDED|90.0|-0.83|0.29||One-Sided P-Value|t-test, 1 sided|||Mean Difference between Non-Responders and Responders||0.29|-0.83|0.213
72540862|NCT02720094|144610666|SUPERIORITY||A bias-adjusted hazard ratio|0.34||||0.0005|TWO_SIDED|95.0|0.18|0.62|||Regression, Cox||The bias-adjusted hazard ratio, CI, and p-value account for the group-sequential trial design and the early stopping time.|||0.62|0.18|0.0005
72540863|NCT02720094|144610666|SUPERIORITY||Hazard Ratio (HR)|0.328||||0.0005|TWO_SIDED|95.0|0.18|0.61|||Regression, Cox||The unadjusted hazard ratio is based on a Cox proportional hazards model stratified by region.|||0.61|0.18|0.0005
72540864|NCT02720094|144610668|SUPERIORITY||Hazard Ratio (HR)|0.21|||<|0.001|TWO_SIDED|95.0|0.1|0.45||The P-Values are two-sided.|Regression, Cox|||The analysis population Injection Step 2 Efficacy consists of the subset of the mITT population who received at least one injection and had at least one HIV test result after the week 5 injection visit.||0.45|0.10|<0.001
72540865|NCT02913261|144610677|SUPERIORITY||Odds Ratio (OR)|2.64|||<|0.0001|TWO_SIDED|95.0|1.65|4.22|||Stratified Cochran-Mantel-Haenszel|||||4.22|1.65|<.0001
72540866|NCT02913261|144610678|SUPERIORITY||Odds Ratio (OR)|2.38||||0.0005|TWO_SIDED|95.0|1.43|3.94|||Stratified Cochran-Mantel-Haenszel|||||3.94|1.43|0.0005
72540867|NCT02913261|144610679|SUPERIORITY||Odds Ratio (OR)|1.98||||0.0029|TWO_SIDED|95.0|1.24|3.17|||Stratified Cochran-Mantel-Haenszel|||||3.17|1.24|0.0029
72540868|NCT02913261|144610691|SUPERIORITY||Odds Ratio (OR)|3.07|||<|0.0001|TWO_SIDED|95.0|1.8|5.25|||Stratified Cochran-Mantel-Haenszel|||||5.25|1.80|<.0001
72540869|NCT01211613|144610705|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.0|STANDARD_DEVIATION|14.0||0.009|TWO_SIDED|95.0||||The p value above relates to the comparison of differences in baseline/4-week Oswestry change scores between manual and mechanical manipulation methods (primary hypothesis). A priori threshold for statistical significance was set at p \< 0.05.|Regression, Linear|Linear regression model was adjusted for these covariates: baseline Oswestry score, age, and treatment expectancy.||||||0.009
72540870|NCT01211613|144610706|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED|||||The p value above relates to the comparison of differences in baseline/4-week Numeric pain change scores between manual and mechanical manipulation methods (secondary hypothesis). A priori threshold for statistical significance was set at p \< 0.05.|Regression, Linear|Linear regression model was adjusted for these covariates: baseline Numeric pain score, age, and treatment expectancy.||||||0.002
72540871|NCT03853213|144610707|SUPERIORITY||Mean difference (in change score)|2.54||||0.698|TWO_SIDED|95.0|-11.62|16.71|||t-test, 2 sided|The p-value is adjusted using the Satterthwaite correction due to unequal variances between the two groups.|A higher value of the estimation parameter of mean difference in change score indicates a greater reduction in the measure for the intervention group relative to the attention control group.|||16.71|-11.62|0.698
72627608|NCT00565409|144783933|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Week 88 censored data was censored at 372 days.|Log Rank|||||||<0.0001
72540872|NCT03853213|144610708|SUPERIORITY||Mean Difference (Final Values)|-3.88||||0.123|TWO_SIDED|95.0|-9.0|1.24|||t-test, 2 sided||A lower value of the estimation parameter of mean difference indicates lower extent of medication nonadherence for the intervention relative to the control group.|Note that the measure of extent of medication nonadherence used the older 5-item version of the scale rather than the newer 3-item version of the scale because the IRB modification to change the measure took effect after the majority of participants who provided data for Visit 2 had completed the measure.||1.24|-9.00|0.123
72575513|NCT02784444|144677100|SUPERIORITY||Mean Difference (Final Values)|-0.6||||0.023|TWO_SIDED|95.0|-1.1|-0.1||Statistical testing was two-sided using a significance (alpha) level of 0.05. No adjustment for multiple comparisons.|ANCOVA|Model adjusted by age, sex, presence of diabetes mellitus, Vitamin E ≥ 400 IU, baseline fibrosis F1 versus F2/F3, and baseline NAS (0-8).||The null hypothesis is that there is no difference in changes between the MSDC-0602K dose and placebo.||-0.1|-1.1|0.023
72575514|NCT02784444|144677100|SUPERIORITY||Mean Difference (Final Values)|-0.5||||0.028|TWO_SIDED|95.0|-1.0|-0.1||Statistical testing was two-sided using a significance (alpha) level of 0.05. No adjustment for multiple comparisons.|ANCOVA|Model adjusted by age, sex, presence of diabetes mellitus, Vitamin E ≥ 400 IU, baseline fibrosis F1 versus F2/F3, and baseline NAS (0-8).||The null hypothesis is that there is no difference in changes between the MSDC-0602K dose and placebo.||-0.1|-1.0|0.028
72575515|NCT02784444|144677101|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.224|TWO_SIDED|95.0|-0.4|0.1||Statistical testing was two-sided using a significance (alpha) level of 0.05. No adjustment for multiple comparisons.|ANCOVA|Model adjusted by age, sex, presence of diabetes mellitus, Vitamin E ≥ 400 IU, baseline fibrosis F1 versus F2/F3, and baseline steatosis.||The null hypothesis is that there is no difference in changes between the MSDC-0602K dose and placebo.||0.1|-0.4|0.224
72575516|NCT02784444|144677101|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.096|TWO_SIDED|95.0|-0.4|0.0||Statistical testing was two-sided using a significance (alpha) level of 0.05. No adjustment for multiple comparisons.|ANCOVA|Model adjusted by age, sex, presence of diabetes mellitus, Vitamin E ≥ 400 IU, baseline fibrosis F1 versus F2/F3, and baseline steatosis.||The null hypothesis is that there is no difference in changes between the MSDC-0602K dose and placebo.||0.0|-0.4|0.096
72575517|NCT02784444|144677101|SUPERIORITY||Mean Difference (Final Values)|-0.3||||0.007|TWO_SIDED|95.0|-0.6|-0.1||Statistical testing was two-sided using a significance (alpha) level of 0.05. No adjustment for multiple comparisons.|ANCOVA|Model adjusted by age, sex, presence of diabetes mellitus, Vitamin E ≥ 400 IU, baseline fibrosis F1 versus F2/F3, and baseline steatosis.||The null hypothesis is that there is no difference in changes between the MSDC-0602K dose and placebo.||-0.1|-0.6|0.007
72575518|NCT02784444|144677102|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.488|TWO_SIDED|95.0|-0.1|0.2||Statistical testing was two-sided using a significance (alpha) level of 0.05. No adjustment for multiple comparisons.|ANCOVA|Model adjusted by age, sex, presence of diabetes mellitus, Vitamin E ≥ 400 IU, baseline fibrosis F1 versus F2/F3, and baseline inflammation.||The null hypothesis is that there is no difference in changes between the MSDC-0602K dose and placebo.||0.2|-0.1|0.488
72575519|NCT02784444|144677102|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.291|TWO_SIDED|95.0|-0.3|0.1||Statistical testing was two-sided using a significance (alpha) level of 0.05. No adjustment for multiple comparisons.|ANCOVA|Model adjusted by age, sex, presence of diabetes mellitus, Vitamin E ≥ 400 IU, baseline fibrosis F1 versus F2/F3, and baseline inflammation.||The null hypothesis is that there is no difference in changes between the MSDC-0602K dose and placebo.||0.1|-0.3|0.291
72575520|NCT02784444|144677102|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.595|TWO_SIDED|95.0|-0.2|0.1||Statistical testing was two-sided using a significance (alpha) level of 0.05. No adjustment for multiple comparisons.|ANCOVA|Model adjusted by age, sex, presence of diabetes mellitus, Vitamin E ≥ 400 IU, baseline fibrosis F1 versus F2/F3, and baseline inflammation.||The null hypothesis is that there is no difference in changes between the MSDC-0602K dose and placebo.||0.1|-0.2|0.595
72575521|NCT02784444|144677103|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.416|TWO_SIDED|95.0|-0.4|0.2||Statistical testing was two-sided using a significance (alpha) level of 0.05. No adjustment for multiple comparisons.|ANCOVA|Model adjusted by age, sex, presence of diabetes mellitus, Vitamin E ≥ 400 IU, baseline fibrosis F1 versus F2/F3, and baseline ballooning.||The null hypothesis is that there is no difference in changes between the MSDC-0602K dose and placebo.||0.2|-0.4|0.416
72627609|NCT00565409|144783937|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.81|||<|0.0001|TWO_SIDED|95.0|-1.1|-0.5||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 40||-0.5|-1.1|<0.0001
72627610|NCT00565409|144783937|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.04||||0.8015|TWO_SIDED|95.0|-0.3|0.3||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 40||0.3|-0.3|0.8015
72369243|NCT00611026|144248560|SUPERIORITY_OR_OTHER|||||||0.2126|TWO_SIDED||||||Van Elteren's Test|P-value based on Van Elteren's Test (a stratified Wilcoxon-Mann Whitney test) adjusted by baseline UUI quartile.||Treatment difference fesoterodine vs Tolterodine ER at Week 1. Winsorized means (5% of the tails were censored, ie, replaced with the value at the 5th and 95th percentile, respectively).||||0.2126
72540873|NCT03853213|144610709|SUPERIORITY||Mean difference (in change score)|66.29||||0.965|TWO_SIDED|95.0|-3081.7|3214.3|||t-test, 2 sided|||||3214.3|-3081.7|0.965
72627611|NCT00565409|144783937|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.78|||<|0.0001|TWO_SIDED|95.0|-1.1|-0.5||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 40||-0.5|-1.1|<0.0001
72627612|NCT00565409|144783937|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.14|||<|0.0001|TWO_SIDED|95.0|-1.5|-0.7||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 48||-0.7|-1.5|<0.0001
72627613|NCT00565409|144783937|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.04||||0.8534|TWO_SIDED|95.0|-0.4|0.4||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 48||0.4|-0.4|0.8534
72575522|NCT02784444|144677103|SUPERIORITY||Mean Difference (Final Values)|-0.3||||0.056|TWO_SIDED|95.0|-0.5|0.0||Statistical testing was two-sided using a significance (alpha) level of 0.05. No adjustment for multiple comparisons.|ANCOVA|Model adjusted by age, sex, presence of diabetes mellitus, Vitamin E ≥ 400 IU, baseline fibrosis F1 versus F2/F3, and baseline ballooning.||The null hypothesis is that there is no difference in changes between the MSDC-0602K dose and placebo.||0.0|-0.5|0.056
72575523|NCT02784444|144677103|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.22|TWO_SIDED|95.0|-0.4|0.1||Statistical testing was two-sided using a significance (alpha) level of 0.05. No adjustment for multiple comparisons.|ANCOVA|Model adjusted by age, sex, presence of diabetes mellitus, Vitamin E ≥ 400 IU, baseline fibrosis F1 versus F2/F3, and baseline ballooning.||The null hypothesis is that there is no difference in changes between the MSDC-0602K dose and placebo.||0.1|-0.4|0.220
72575524|NCT02784444|144677104|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.928|TWO_SIDED|95.0|-0.3|0.3||Statistical testing was two-sided using a significance (alpha) level of 0.05. No adjustment for multiple comparisons.|ANCOVA|Model adjusted by age, sex, diabetes mellitus, Vitamin E ≥ 400 IU, baseline fibrosis F1 vs. F2/F3, and baseline CRN fibrosis staging score.||The null hypothesis is that there is no difference in changes between the MSDC-0602K dose and placebo.||0.3|-0.3|0.928
72575525|NCT02784444|144677104|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.244|TWO_SIDED|95.0|-0.5|0.1||Statistical testing was two-sided using a significance (alpha) level of 0.05. No adjustment for multiple comparisons.|ANCOVA|Model adjusted by age, sex, diabetes mellitus, Vitamin E ≥ 400 IU, baseline fibrosis F1 vs. F2/F3, and baseline CRN fibrosis staging score.||The null hypothesis is that there is no difference in changes between the MSDC-0602K dose and placebo.||0.1|-0.5|0.244
72575526|NCT02784444|144677104|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.228|TWO_SIDED|95.0|-0.5|0.1||Statistical testing was two-sided using a significance (alpha) level of 0.05. No adjustment for multiple comparisons.|ANCOVA|Model adjusted by age, sex, diabetes mellitus, Vitamin E ≥ 400 IU, baseline fibrosis F1 vs. F2/F3, and baseline CRN fibrosis staging score.||The null hypothesis is that there is no difference in changes between the MSDC-0602K dose and placebo.||0.1|-0.5|0.228
72575527|NCT04314648|144677150|SUPERIORITY||Odds Ratio (OR)|6.26|||<|0.001|TWO_SIDED|95.0|2.38|16.48|||Regression, Logistic|||||16.48|2.38|<.001
72575528|NCT04314648|144677151|SUPERIORITY||Odds Ratio, log|5.76|||<|0.01|TWO_SIDED|95.0|1.86|17.86|||Regression, Logistic|||||17.86|1.86|<.01
72575529|NCT04314648|144677152|SUPERIORITY||Odds Ratio (OR)|0.74||||0.64|TWO_SIDED|95.0|0.21|2.64|||Regression, Logistic||Main effects of the intervention on this outcome were compared between arms by fitting follow-up values to a logistic regression model, adjusted for baseline use.|||2.64|.21|.64
72575530|NCT04314648|144677153|SUPERIORITY||Odds Ratio (OR)|2.67||||0.35|TWO_SIDED|95.0|0.35|20.51|||Regression, Logistic||Main effects of the intervention on this outcome were compared between arms by fitting follow-up values to a logistic regression model, adjusted for baseline use.|||20.51|.35|.35
72575531|NCT04314648|144677154|SUPERIORITY||Mean Difference (Net)|-1.85|STANDARD_ERROR_OF_MEAN|2.32||0.43|TWO_SIDED||||||Regression, Linear||Main effects of the intervention on this outcome were compared between arms by fitting follow-up values to a linear regression model, adjusted for baseline use.|||||.43
72575532|NCT04314648|144677155|SUPERIORITY||Mean Difference (Net)|2.35|STANDARD_ERROR_OF_MEAN|3.0||0.44|TWO_SIDED||||||Regression, Linear||Main effects of the intervention on this outcome were compared between arms by fitting follow-up values to a liner regression model, adjusted for baseline use.|||||.44
72575533|NCT04314648|144677156|SUPERIORITY||Odds Ratio (OR)|1.19||||0.77|TWO_SIDED|95.0|0.39|3.62|||Regression, Logistic|||||3.62|.39|.77
72627614|NCT00565409|144783937|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.18|||<|0.0001|TWO_SIDED|95.0|-1.6|-0.8||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 48||-0.8|-1.6|<0.0001
72369244|NCT00611026|144248560|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Van Elteren's Test|P-value based on Van Elteren's Test (a stratified Wilcoxon-Mann Whitney test) adjusted by baseline UUI quartile.||Treatment difference fesoterodine vs placebo at Week 4. Winsorized means (5% of the tails were censored, ie, replaced with the value at the 5th and 95th percentile, respectively).||||<0.0001
72575534|NCT00492024|144677166|SUPERIORITY_OR_OTHER|||||||0.189||95.0||||P-value is adjusted for study center; p-value applies to percentage of subjects with success (clinical cure)|Cochran-Mantel-Haenszel|Adjusted for study center||Null hypothesis is that the success rate for moxifloxacin = the success rate for placebo||||0.189
72575535|NCT00492024|144677171|SUPERIORITY_OR_OTHER|||||||0.075||95.0||||p-value adjusted for study center; p-value applies to percentage of subjects with success (clinical cure)|Cochran-Mantel-Haenszel|adjusted for study center||Null hypothesis is that the success rate for moxifloxacin = the success rate for placebo||||0.075
72369245|NCT00611026|144248560|SUPERIORITY_OR_OTHER|||||||0.0019|TWO_SIDED||||||Van Elteren's Test|P-value based on Van Elteren's Test (a stratified Wilcoxon-Mann Whitney test) adjusted by baseline UUI quartile.||Treatment difference Tolterodine ER vs placebo at Week 4. Winsorized means (5% of the tails were censored, ie, replaced with the value at the 5th and 95th percentile, respectively).||||0.0019
72576811|NCT00261443|144680655|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.29||||0.029|TWO_SIDED|95.0|-0.56|-0.03||Baseline: ANOVA model, controlling for treatment, mood stabilizer, and index mood episode. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 28 Comparison||-0.03|-0.56|0.029
72576812|NCT00261443|144680655|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.31||||0.024|TWO_SIDED|95.0|-0.57|-0.04||Baseline: ANOVA model, controlling for treatment, mood stabilizer, and index mood episode. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 32 Comparison||-0.04|-0.57|0.024
72576813|NCT00261443|144680655|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.29||||0.035|TWO_SIDED|95.0|-0.56|-0.02||Baseline: ANOVA model, controlling for treatment, mood stabilizer, and index mood episode. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 36 Comparison||-0.02|-0.56|0.035
72627615|NCT00565409|144783937|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.21|||<|0.0001|TWO_SIDED|95.0|-1.7|-0.8||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 56||-0.8|-1.7|<0.0001
72575536|NCT04623086|144677232|OTHER|Comparison of two groups|Mean Difference (Net)|8.1||||0.14|TWO_SIDED||||||t-test, 2 sided|||For our power calculations, we assumed the true change in TIR to be 0% for the bridging group and 15% for the direct-conversion group, and we assumed a common standard deviation of 15% (meaning the distributions of change in TIR are separated by 1 standard-deviation unit), and thereby obtained that 20 patients in each group would provide 87% power to observe a statistically significant (at the two-sided level of .05) difference in mean change of TIR.||||0.14
72575537|NCT04623086|144677233|OTHER|Comparison of two groups|Mean Difference (Net)|4.1||||0.11|TWO_SIDED||||||t-test, 2 sided|||||||0.11
72575538|NCT04623086|144677234|OTHER|Comparison of two groups|Mean Difference (Net)|12.1||||0.29|TWO_SIDED||||||t-test, 2 sided|||||||0.29
72575539|NCT04623086|144677235|OTHER|Comparison of two groups|Mean Difference (Net)|-11.9||||0.015|TWO_SIDED||||||t-test, 2 sided|||||||0.015
72575540|NCT04623086|144677236|OTHER||Mean Difference (Net)|0.3||||0.88|TWO_SIDED||||||t-test, 2 sided|||||||0.88
72575541|NCT04623086|144677237|OTHER|Comparison of two groups|Mean Difference (Net)|2.6||||0.031|TWO_SIDED||||||t-test, 2 sided|||||||0.031
72575542|NCT04623086|144677238|OTHER|Comparison of two groups|Mean Difference (Net)|1.1||||0.27|TWO_SIDED||||||t-test, 2 sided|||||||0.27
72575543|NCT04623086|144677239|OTHER|Comparison of two groups|Mean Difference (Net)|0.0|||>|0.99|TWO_SIDED||||||t-test, 2 sided|||||||>0.99
72575544|NCT00875797|144677240|NON_INFERIORITY_OR_EQUIVALENCE|t-test||||||0.05|TWO_SIDED|95.0||||p\<0.05|t-test, 2 sided|||||||0.05
72575545|NCT00875797|144677241|NON_INFERIORITY_OR_EQUIVALENCE|χ2 test|percentage of infection|20.0|STANDARD_DEVIATION|10.0||0.05|TWO_SIDED|95.0||||p\<0.05|Chi-squared|2 degrees of freedom||||||0.05
72627616|NCT00565409|144783937|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.03||||0.9074|TWO_SIDED|95.0|-0.4|0.5||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 56||0.5|-0.4|0.9074
72540874|NCT03853213|144610710|SUPERIORITY||Mean difference (in change score)|-6.17||||0.29|TWO_SIDED|95.0|-18.15|5.81|||t-test, 2 sided||A higher value of the estimation parameter of mean difference in change score indicates a greater increase in context sensitivity for the intervention group relative to the attention control group.|||5.81|-18.15|0.290
72369246|NCT00611026|144248560|SUPERIORITY_OR_OTHER|||||||0.0148|TWO_SIDED||||||Van Elteren's Test|P-value based on Van Elteren's Test (a stratified Wilcoxon-Mann Whitney test) adjusted by baseline UUI quartile.||Treatment difference fesoterodine vs Tolterodine ER at Week 4. Winsorized means (5% of the tails were censored, ie, replaced with the value at the 5th and 95th percentile, respectively).||||0.0148
72540875|NCT03853213|144610711|SUPERIORITY||Mean difference (in change score)|-5.07||||0.434|TWO_SIDED|95.0|-18.51|8.38|||t-test, 2 sided||A higher value of the estimation parameter of mean difference in change score indicates a greater increase in future time perspective for the intervention group relative to the attention control group.|||8.38|-18.51|0.434
72540876|NCT03853213|144610712|SUPERIORITY||Mean Difference (Final Values)|17.05||||0.293|TWO_SIDED|95.0|-19.07|53.17|||t-test, 2 sided||A higher value of the estimation parameter of mean difference indicates a lower extent of objectively measured medication adherence for the intervention relative to the control group.|||53.17|-19.07|0.293
72540877|NCT02239692|144610737|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is assessed by examining whether the upper limit of the 95% confidence interval is less than the specified non-inferiority margin of 1.5 points.|Adjusted estimated mean difference|-3.93|||<|0.0001|TWO_SIDED|95.0|-4.99|-2.87||p-value corresponds to a two-sided test of superiority.|ANCOVA|ANCOVA with treatment, country and time of colonoscopy (AM/PM) as factors.|Treatment difference in mean total Ottawa Scale score was calculated as PICOPREP tailored dosing schedule minus PICOPREP day-before dosing schedule.|Null hypothesis was no treatment difference between the two dosing schedules.||-2.87|-4.99|<0.0001
72575546|NCT00875797|144677242|SUPERIORITY_OR_OTHER||percentage of survivers|80.0|||<|0.05||95.0||||p\<0.05|Chi-squared, Corrected|2-degrees of freedom||Chi-square||||<0.05
72575547|NCT00715624|144677243|SUPERIORITY_OR_OTHER||Least squares (LS) mean difference|-0.36|STANDARD_ERROR_OF_MEAN|0.096||0.0002|TWO_SIDED|95.0|-0.55|-0.174||Statistical testing: 2-sided at significance level=0.05. Analysis of co-variance (ANCOVA) included treatment arms, randomization strata of screening HbA1c (\<8.0, \>=8.0%), metformin use (yes, no), country as fixed effects, baseline HbA1c as covariate.|ANCOVA|To control type I error, a step-down procedure described by Hochberg and Tomhane was applied.||To detect a difference of 0.5% (or 0.4%) in change from baseline to Week 24 in HbA1c between lixisenatide and placebo, 300 patients in lixisenatide arm and 150 in placebo arm would provide a power of 96% (or 86%) assuming common standard deviation of 1.3% with a 2-sided test at 5% significance level.||-0.174|-0.550|0.0002
72575548|NCT03200912|144677255|EQUIVALENCE|Primary Efficacy Endpoint - AK Complete Clearance Rates at Day 57 (PP and mITT Populations)|Mean Difference (Net)|2.29|||||TWO_SIDED|90.0|-7.55|12.14||||||||12.14|-7.55|
72575549|NCT03421730|144677286|OTHER||Geometric mean ratio (%)|8.69|||||TWO_SIDED||||||||A: n=6; D: n=5||The intra-subject coefficient of variation was 25.33%.|||
72575550|NCT03421730|144677286|OTHER||Geometric mean ratio (%)|28.18|||||TWO_SIDED||||||||B: n=6, D: n=5||The intra-subject coefficient of variation was 25.33%.|||
72575551|NCT03421730|144677286|OTHER||Geometric mean ratio (%)|59.51|||||TWO_SIDED||||||||C: n=6, D: n=5||The intra-subject coefficient of variation was 25.33%.|||
72575552|NCT03421730|144677287|OTHER||Geometric mean ratio (%)|13.35|||||TWO_SIDED||||||||A: n=4, D: n=4||The intra-subject coefficient of variation was 22.05%.|||
72575553|NCT03421730|144677287|OTHER||Geometric mean ratio (%)|35.97|||||TWO_SIDED||||||||B: n=4, D: n=4||The intra-subject coefficient of variation was 22.05%|||
72575554|NCT03421730|144677287|OTHER||Geometric mean ratio (%)|76.98|||||TWO_SIDED||||||||C: n=4, D: n=4||The intra-subject coefficient of variation was 22.05%|||
72575555|NCT03421730|144677288|OTHER||Geometric mean ratio (%)|9.55|||||TWO_SIDED||||||||A: n=6, D: n=5||The intra-subject coefficient of variation was 33.04%.|||
72575556|NCT03421730|144677288|OTHER||Geometric mean ratio (%)|32.42|||||TWO_SIDED||||||||B: n=6, D: n=5||The intra-subject coefficient of variation was 33.04%.|||
72540878|NCT02239692|144610738|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is assessed by examining whether the upper limit of the 95% confidence interval is less than the specified non-inferiority margin of 1.5 points.|Adjusted estimated mean difference|-4.38|||<|0.0001|TWO_SIDED|95.0|-5.34|-3.41||p-value corresponds to a two-sided test of superiority.|ANCOVA|ANCOVA with treatment, country and time of colonoscopy (AM/PM) as factors.|Treatment difference in mean total Ottawa Scale score was calculated as PICOPREP tailored dosing schedule minus PICOPREP day-before dosing schedule.|Null hypothesis was no treatment difference between the two dosing schedules.||-3.41|-5.34|<0.0001
72540879|NCT02239692|144610739|SUPERIORITY_OR_OTHER||Adjusted estimated odds ratio|9.18|||<|0.0001|TWO_SIDED|95.0|4.36|19.32||p-value corresponds to a two-sided test of superiority.|Regression, Logistic|Logistic regression with the failure/success status as dependent variable, and treatment, country and timing of colonoscopy as factors.|The estimated odds ratio compares the odds of being a responder in the PICOPREP tailored dosing schedule vs. the PICOPREP day-before dosing schedule.|Null hypothesis was no treatment difference between the two dosing schedules.||19.32|4.36|<0.0001
72540880|NCT00297492|144610743|SUPERIORITY_OR_OTHER|||||||0.3||95.0||||Statistical significance was determined by a two-sided p value less than 0.05.|Chi-squared|Degrees of freedom = 2||"Null hypothesis: prolonged abstinence from smoking is the same for the three groups at 6 month follow-up~Sample size was based on an assumption of 6 month abstinence of 25% in the gradual group, 15% in the abrupt group, and 10% in the minimal group. Sample sizes of 300, 300, and 150 for gradual, abrupt, and minimal provides 97% to detect a difference between the groups, with 2-sided alpha = 0.05."||||0.30
72540881|NCT00297492|144610743|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.59|||||TWO_SIDED|95.0|0.28|1.22|||||The reported odds ratio represents the odds of 6 month prolonged abstinence in the gradual reduction group divided by the odds of 6 month prolonged abstinence in the abrupt cessation group.|||1.22|0.28|
72540882|NCT01875991|144610763|SUPERIORITY_OR_OTHER|||||||0.501|||||||Van Elteren test|P-value for 'All subjects' from Van Elteren test adjusting for strata (RA or PsO)||||||0.501
72540883|NCT04991311|144610802|SUPERIORITY||Mean Difference (Final Values)|398.4|STANDARD_DEVIATION|581.6|=|0.0585|TWO_SIDED|95.0|-17.6|814.4|||Paired t-test (2-sided, alpha=0.05)|||The participants in both comparison groups are the same.||814.4|-17.6|= 0.0585
72575557|NCT03421730|144677288|OTHER||Geometric mean ratio (%)|59.75|||||TWO_SIDED||||||||C: n=6, D: n=5||The intra-subject coefficient of variation was 33.04%.|||
72575558|NCT00118534|144677302|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.09||||0.007|TWO_SIDED|95.0|1.22|3.59|||Regression, Logistic|||The target sample size (n=1400)was designed to have 90% power to detect the difference between 6% and 11% prolonged abstinence rates in SCC and IC, respectively, using a 2-sided .05 level Chi-square test. Final enrollment was 943. The recruitment period was not extended because the achieved sample size provided 78% power to detect the hypothesized prolonged abstinence rates, and the study continued to the end of planned follow-up.||3.59|1.22|0.007
72575559|NCT00118534|144677303|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.43|||<|0.001|TWO_SIDED|95.0|1.58|3.74|||Regression, Logistic|||||3.74|1.58|<0.001
72575560|NCT01955083|144677347|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|17.0|STANDARD_DEVIATION|16.0|<|0.05|TWO_SIDED|95.0|-14.4|48.4|||Wilcoxon (Mann-Whitney)|||We hypothesized that pillar implant provide a better efficacy in the treatment of snoring than radiofrequency surgery. The sample size was estimated using the primary outcome effects (VAS) in two previously published studies (Friedman 2008; Fang 2004). Using a two-tailed Wilcoxon signed-rank test (normal parent distribution; effect size, 1.0; type I error, 0.05; power, 80%), we got a sample size of 11. For considering a 20% drop-out rate, we needed at least 14 participants.||48.4|-14.4|<0.05
72575561|NCT01955083|144677348|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
72575562|NCT01955083|144677349|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
72575563|NCT01955083|144677350|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
72575564|NCT01955083|144677351|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
72575565|NCT01955083|144677352|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
72575566|NCT01955083|144677353|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
72627617|NCT00565409|144783937|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.24|||<|0.0001|TWO_SIDED|95.0|-1.7|-0.8||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 56||-0.8|-1.7|<0.0001
72540884|NCT00755937|144610829|SUPERIORITY_OR_OTHER||Percentage (no inferential test)|66.3||||||||||There were no comparisons between groups as this was a single-arm observational study.||||||||
72540885|NCT00755937|144610830|SUPERIORITY_OR_OTHER||percentage (no inferential test)|72.5||||||||||There were no comparisons between groups as this was a single-arm observational study.||||||||
72575567|NCT01955083|144677354|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
72575568|NCT01955083|144677355|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
72575569|NCT01955083|144677356|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
72575570|NCT01955083|144677357|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
72575571|NCT01955083|144677358|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
72575572|NCT01955083|144677359|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Fisher Exact|||||||<0.05
72575573|NCT02871492|144677361|SUPERIORITY|||||||0.4294|||||||Cochran-Mantel-Haenszel|||||||0.4294
72575574|NCT02256436|144677362|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.98||||0.41648|TWO_SIDED|95.0|0.81|1.19||One-sided p-value based on stratified log-rank test|Regression, Cox|Treatment as a covariate stratified by ECOG PS, presence/absence of liver metastases, hemoglobin and time from completion of most recent chemotherapy||PFS - All Participants||1.19|0.81|0.41648
72575575|NCT02256436|144677363|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.73||||0.00224|TWO_SIDED|95.0|0.59|0.91||One-sided p-value based on stratified log-rank test|Regression, Cox|Treatment as a covariate stratified by ECOG PS, presence/absence of liver metastases, hemoglobin and time from completion of most recent chemotherapy||OS - All Participants (Note: ECOG PS=Eastern Cooperative Oncology Group Performance Status)||0.91|0.59|0.00224
72627618|NCT00565409|144783937|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.28|||<|0.0001|TWO_SIDED|95.0|-1.8|-0.8||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 64||-0.8|-1.8|<0.0001
72627619|NCT00565409|144783937|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.02||||0.9229|TWO_SIDED|95.0|-0.4|0.5||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 64||0.5|-0.4|0.9229
72627620|NCT00565409|144783937|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.3|||<|0.0001|TWO_SIDED|95.0|-1.8|-0.8||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 64||-0.8|-1.8|<0.0001
72627621|NCT00565409|144783937|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.44|||<|0.0001|TWO_SIDED|95.0|-1.9|-1.0||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 72||-1.0|-1.9|<0.0001
72627622|NCT00565409|144783937|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02||||0.9279|TWO_SIDED|95.0|-0.5|0.4||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 72||0.4|-0.5|0.9279
72627623|NCT00565409|144783937|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.42|||<|0.0001|TWO_SIDED|95.0|-1.9|-1.0||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 72||-1.0|-1.9|<0.0001
72627624|NCT00565409|144783937|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.58|||<|0.0001|TWO_SIDED|95.0|-2.1|-1.1||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 80||-1.1|-2.1|<0.0001
72627625|NCT00565409|144783937|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.07||||0.7695|TWO_SIDED|95.0|-0.6|0.4||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 80||0.4|-0.6|0.7695
72627626|NCT00565409|144783937|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.5|||<|0.0001|TWO_SIDED|95.0|-2.0|-1.0||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 80||-1.0|-2.0|<0.0001
72409846|NCT01639001|144328167|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-6.0432||||0.0016|TWO_SIDED|95.0|-9.79|-2.3|||Mixed Models Analysis|||Analysis presented for QLQ-C30 appetite loss. Estimated change from baseline was from a repeated measures mixed-effects model with an intercept term, treatment, visit day and baseline EORTC QLQ-C30 subscale score (intercept and visit day are included as random effects). P-values and confidence intervals are not adjusted for multiplicity.||-2.30|-9.79|0.0016
72627627|NCT00565409|144783937|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.75|||<|0.0001|TWO_SIDED|95.0|-2.3|-1.2||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 88||-1.2|-2.3|<0.0001
72627628|NCT00565409|144783937|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.31||||0.2182|TWO_SIDED|95.0|-0.8|0.2||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 88||0.2|-0.8|0.2182
72627629|NCT00565409|144783937|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.44|||<|0.0001|TWO_SIDED|95.0|-1.9|-0.9||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 88||-0.9|-1.9|<0.0001
72627630|NCT00565409|144783940|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.86||||0.0003|TWO_SIDED|95.0|-1.3|-0.4||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 40||-0.4|-1.3|0.0003
72627631|NCT00565409|144783940|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.12||||0.6088|TWO_SIDED|95.0|-0.3|0.6||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 40||0.6|-0.3|0.6088
72627632|NCT00565409|144783940|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.98|||<|0.0001|TWO_SIDED|95.0|-1.4|-0.5||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 40||-0.5|-1.4|<0.0001
72627633|NCT00565409|144783940|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.02|||<|0.0001|TWO_SIDED|95.0|-2.6|-1.4||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 48||-1.4|-2.6|<0.0001
72627634|NCT00565409|144783940|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.04||||0.9048|TWO_SIDED|95.0|-0.5|0.6||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANOVA|||Week 48||0.6|-0.5|0.9048
72627635|NCT00565409|144783940|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.06|||<|0.0001|TWO_SIDED|95.0|-2.6|-1.5||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 48||-1.5|-2.6|<0.0001
72627636|NCT00565409|144783940|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.06|||<|0.0001|TWO_SIDED|95.0|-2.6|-1.5||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 56||-1.5|-2.6|<0.0001
72627637|NCT00565409|144783940|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.06||||0.8437|TWO_SIDED|95.0|-0.6|0.5||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 56||0.5|-0.6|0.8437
72575576|NCT02256436|144677364|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.91||||0.26443|TWO_SIDED|95.0|0.68|1.24||One-sided p-value based on stratified log-rank test|Regression, Cox|Treatment as a covariate stratified by ECOG PS, presence/absence of liver metastases, hemoglobin and time from completion of most recent chemotherapy||PFS - PD-L1 positive participants||1.24|0.68|0.26443
72627638|NCT00565409|144783940|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.0|||<|0.0001|TWO_SIDED|95.0|-2.6|-1.4||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 56||-1.4|-2.6|<0.0001
72627639|NCT00565409|144783940|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.98|||<|0.0001|TWO_SIDED|95.0|-2.6|-1.4||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 64||-1.4|-2.6|<0.0001
72627640|NCT00565409|144783940|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.06||||0.8587|TWO_SIDED|95.0|-0.6|0.7||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 64||0.7|-0.6|0.8587
72627641|NCT00565409|144783940|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.03|||<|0.0001|TWO_SIDED|95.0|-2.6|-1.4||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 64||-1.4|-2.6|<0.0001
72627642|NCT00565409|144783940|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.38|||<|0.0001|TWO_SIDED|95.0|-3.0|-1.8||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 72||-1.8|-3.0|<0.0001
72627643|NCT00565409|144783940|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.15||||0.6323|TWO_SIDED|95.0|-0.8|0.5||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 72||0.5|-0.8|0.6323
72627644|NCT00565409|144783940|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.23|||<|0.0001|TWO_SIDED|95.0|-2.9|-1.6||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 72||-1.6|-2.9|<0.0001
72627645|NCT00565409|144783940|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.28|||<|0.0001|TWO_SIDED|95.0|-2.9|-1.6||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 80||-1.6|-2.9|<0.0001
72627646|NCT00565409|144783940|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.15||||0.6558|TWO_SIDED|95.0|-0.8|0.5||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 80||0.5|-0.8|0.6558
72575577|NCT02256436|144677365|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.61||||0.00239|TWO_SIDED|95.0|0.43|0.86||One-sided p-value based on stratified log-rank test|Regression, Cox|Treatment as a covariate stratified by ECOG PS, presence/absence of liver metastases, hemoglobin and time from completion of most recent chemotherapy||OS - PD-L1 positive participants||0.86|0.43|0.00239
72575578|NCT02256436|144677366|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.89||||0.23958|TWO_SIDED|95.0|0.61|1.28||One-sided p-value based on stratified log-rank test|Regression, Cox|Treatment as a covariate stratified by ECOG PS, presence/absence of liver metastases, hemoglobin and time from completion of most recent chemotherapy||PFS - Strongly PD-L1 positive participants||1.28|0.61|0.23958
72575579|NCT02256436|144677367|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.57||||0.00483|TWO_SIDED|95.0|0.37|0.88||One-sided p-value based on stratified log-rank test|Regression, Cox|Treatment as a covariate stratified by ECOG PS, presence/absence of liver metastases, hemoglobin and time from completion of most recent chemotherapy||OS - Strongly PD-L1 positive participants||0.88|0.37|0.00483
72627647|NCT00565409|144783940|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.14|||<|0.0001|TWO_SIDED|95.0|-2.8|-1.5||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 80||-1.5|-2.8|<0.0001
72627648|NCT00565409|144783940|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.41|||<|0.0001|TWO_SIDED|95.0|-3.1|-1.7||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 88||-1.7|-3.1|<0.0001
72627649|NCT00565409|144783940|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.06||||0.8688|TWO_SIDED|95.0|-0.7|0.6||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 88||0.6|-0.7|0.8688
72627650|NCT00565409|144783940|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.35|||<|0.0001|TWO_SIDED|95.0|-3.0|-1.7||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 88||-1.7|-3.0|<0.0001
72627651|NCT00565409|144783943|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.73|||<|0.0001|TWO_SIDED|95.0|-1.0|-0.5||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 40||-0.5|-1.0|<0.0001
72627652|NCT00565409|144783943|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01||||0.9636|TWO_SIDED|95.0|-0.2|0.3||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 40||0.3|-0.2|0.9636
72627653|NCT00565409|144783943|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.74|||<|0.0001|TWO_SIDED|95.0|-1.0|-0.5||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 40||-0.5|-1.0|<0.0001
72627654|NCT00565409|144783943|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.11|||<|0.0001|TWO_SIDED|95.0|-1.4|-0.8||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 48||-0.8|-1.4|<0.0001
72627655|NCT00565409|144783943|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.11||||0.4605|TWO_SIDED|95.0|-0.2|0.4||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 48||0.4|-0.2|0.4605
72627656|NCT00565409|144783943|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.22|||<|0.0001|TWO_SIDED|95.0|-1.5|-0.9||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 48||-0.9|-1.5|<0.0001
72627657|NCT00565409|144783943|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.12|||<|0.0001|TWO_SIDED|95.0|-1.4|-0.8||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 56||-0.8|-1.4|<0.0001
72627658|NCT00565409|144783943|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.03||||0.8404|TWO_SIDED|95.0|-0.3|0.3||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 56||0.3|-0.3|0.8404
72627659|NCT00565409|144783943|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.15|||<|0.0001|TWO_SIDED|95.0|-1.4|-0.9||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 56||-0.9|-1.4|<0.0001
72627660|NCT00565409|144783943|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.1|||<|0.0001|TWO_SIDED|95.0|-1.4|-0.8||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 64||-0.8|-1.4|<0.0001
72627661|NCT00565409|144783943|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.16||||0.3118|TWO_SIDED|95.0|-0.1|0.5||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 64||0.5|-0.1|0.3118
72627662|NCT00565409|144783943|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.26|||<|0.0001|TWO_SIDED|95.0|-1.6|-1.0||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 64||-1.0|-1.6|<0.0001
72540886|NCT00755937|144610831|SUPERIORITY_OR_OTHER||Percentage (no inferential test)|72.1||||||||||There were no comparisons between groups as this was a single-arm observational study.||||||||
72627663|NCT00565409|144783943|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.26|||<|0.0001|TWO_SIDED|95.0|-1.6|-0.9||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 72||-0.9|-1.6|<0.0001
72627664|NCT00565409|144783943|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.08||||0.61|TWO_SIDED|95.0|-0.2|0.4||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 72||0.4|-0.2|0.6100
72627665|NCT00565409|144783943|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.34|||<|0.0001|TWO_SIDED|95.0|-1.6|-1.0||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 72||-1.0|-1.6|<0.0001
72627666|NCT00565409|144783943|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.34|||<|0.0001|TWO_SIDED|95.0|-1.6|-1.0||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 80||-1.0|-1.6|<0.0001
72627667|NCT00565409|144783943|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.07||||0.6552|TWO_SIDED|95.0|-0.4|0.2||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 80||0.2|-0.4|0.6552
72627668|NCT00565409|144783943|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.27|||<|0.0001|TWO_SIDED|95.0|-1.6|-1.0||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 80||-1.0|-1.6|<0.0001
72627669|NCT00565409|144783943|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.43|||<|0.0001|TWO_SIDED|95.0|-1.8|-1.1||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 88||-1.1|-1.8|<0.0001
72627670|NCT00565409|144783943|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.12||||0.4753|TWO_SIDED|95.0|-0.4|0.2||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 88||0.2|-0.4|0.4753
72627671|NCT00565409|144783943|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.32|||<|0.0001|TWO_SIDED|95.0|-1.6|-1.0||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 88||-1.0|-1.6|<0.0001
72540887|NCT00755937|144610832|SUPERIORITY_OR_OTHER||Percentage (no inferential test)|60.3||||||||||There were no comparisons between groups as this was a single-arm observational study.||||||||
72627672|NCT00565409|144783946|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.88|||<|0.0001|TWO_SIDED|95.0|-1.2|-0.6||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 40||-0.6|-1.2|<0.0001
72627673|NCT00565409|144783946|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.05||||0.7427|TWO_SIDED|95.0|-0.4|0.3||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 40||0.3|-0.4|0.7427
72627674|NCT00565409|144783946|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.82|||<|0.0001|TWO_SIDED|95.0|-1.1|-0.5||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 40||-0.5|-1.1|<0.0001
72540888|NCT00755937|144610833|SUPERIORITY_OR_OTHER||Percentage (no inferential test)|64.8||||||||||There were no comparisons between groups as this was a single-arm observational study.||||||||
72540889|NCT00755937|144610834|SUPERIORITY_OR_OTHER||Percentage (no inferential test)|72.1||||||||||There were no comparisons between groups as this was a single-arm observational study.||||||||
72540890|NCT01676311|144610836|SUPERIORITY|||||||0.38||||||For each permutation of the data, relevant result was saved and the corresponding p-value represents the proportion of results at least as extreme as observed in the original data.|Regression, Linear|||Regression analysis was run incorporating group, CVLT-II-total learning score at baseline and week 12, and covariates (Beck Depression Index \[BDI\], time post-injury, British Columbia Postconcussion Symptom Inventory \[BC-PSI\]). Regression analyses were repeated, permuting data observations for each outcome. The BDI and BC-PSI are covariates in the regression model and not pre-specified Primary and Secondary Outcome Measures.||||0.38
72540891|NCT01676311|144610836|SUPERIORITY|||||||0.38||||||For each permutation of the data, relevant result was saved and the corresponding p-value represents the proportion of results at least as extreme as observed in the original data.|Regression, Linear|||Regression analysis was run incorporating group (Huperzine A, placebo), baseline CVLT-II-short delay free recall (SDFR) score, outcome (CVLT-II-SDFR at week 12) and covariates (Beck Depression Index, time post-injury, British Columbia Postconcussion Symptom Inventory). Regression analyses were repeated, permuting data observations for each outcome i.e. we permuted the labels (Huperzine A or placebo) among the data observations and re-ran the regression.||||0.38
72540892|NCT01676311|144610836|SUPERIORITY|||||||0.42||||||For each permutation of the data, relevant result was saved and the corresponding p-value represents the proportion of results at least as extreme as observed in the original data.|Regression, Linear|||Regression analysis was run incorporating group (Huperzine A, placebo), baseline CVLT-II-long delay free recall (LDFR) score, outcome (CVLT-II-LDFR at week 12) and covariates (Beck Depression Index, time post-injury, British Columbia Postconcussion Symptom Inventory). Regression analyses were repeated, permuting data observations for each outcome i.e. we permuted the labels (Huperzine A or placebo) among the data observations and re-ran the regression.||||0.42
72540893|NCT01676311|144610839|SUPERIORITY|||||||0.48||||||A chi-square test with factors of group (Huperzine A, placebo) and occurrence of seizure (yes, no) was performed. A permutation test was the used to assess the effect of Huperzine A on the prevalence of seizures.|Chi-squared test and permutation test|||||||0.48
72540894|NCT01676311|144610840|SUPERIORITY|||||||0.44||||||A chi-squared test with factors of group (Huperzine A, placebo) and occurrence of behavioral side effects (yes, no) were performed. A permutation test was used to assess the effect of Huperzine A on the incidence of behavioral side effects.|Chi-squared test and permutation test|||Behavioral side effects statistical analysis||||0.44
72540895|NCT01676311|144610840|SUPERIORITY|||||||0.81||||||A chi-squared test with factors of group (Huperzine A, placebo) and occurrence of cardiac-respiratory side effects (yes, no) were performed. A permutation test was used to assess the effect of Huperzine A on the incidence of these side effects.|Chi-squared test and permutation test|||Cardiac-respiratory side effects statistical analysis||||0.81
72540896|NCT01676311|144610840|SUPERIORITY|||||||0.81||||||A chi-squared test with factors of group (Huperzine A, placebo) and occurrence of dermatological side effects (yes, no) were performed. A permutation test was used to assess the effect of Huperzine A on the incidence of dermatological side effects.|Chi-squared test and permutation test|||Dermatological side effects statistical analysis||||0.81
72540897|NCT01676311|144610840|SUPERIORITY|||||||0.73||||||A chi-squared test with factors of group (Huperzine A, placebo) and occurrence of gastrointestinal side effects (yes, no) were performed. A permutation test was used to assess the effect of Huperzine A on the incidence of these side effects.|Chi-squared test and permutation test|||Gastrointestinal side effects statistical analysis||||0.73
72540898|NCT01676311|144610840|SUPERIORITY|||||||0.54||||||A chi-squared test with factors of group (Huperzine A, placebo) and occurrence of genitourinary/neurological side effects (yes, no) were performed. A permutation test was used to assess the effect of Huperzine A on the incidence of these side effects|Chi-squared test and permutation test|||Genitourinary/neurological side effects statistical analysis||||0.54
72540899|NCT01676311|144610840|SUPERIORITY|||||||0.27||||||A chi-squared test with factors of group (Huperzine A, placebo) and occurrence of hematological side effects (yes, no) were performed. A permutation test was used to assess the effect of Huperzine A on the incidence of these side effects.|Chi-squared test and permutation test|||Hematological side effects statistical analysis||||0.27
72540900|NCT01676311|144610840|SUPERIORITY|||||||0.41||||||A chi-squared test with factors of group (Huperzine A, placebo) and occurrence of musculoskeletal side effects (yes, no) were performed. A permutation test was used to assess the effect of Huperzine A on the incidence of these side effects.|Chi-squared test and permutation test|||Musculoskeletal side effects statistical analysis||||0.41
72575580|NCT02256436|144677370|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentages|17.2||||0.00061|TWO_SIDED|95.0|6.8|29.4||One-sided p-value for testing H0: difference in %=0; H1: difference in %\>0|Miettinen & Nurminen method|Treatment as a covariate stratified by ECOG PS, presence/absence of liver metastases, hemoglobin and time from completion of most recent chemotherapy||ORR per RECIST 1.1 - Strongly PD-L1 Positive Participants||29.4|6.8|0.00061
72575581|NCT02256436|144677371|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentages|15.6||||0.00049|TWO_SIDED|95.0|6.5|25.7||One-sided p-value for testing H0: difference in %=0; H1: difference in %\>0|Miettinen & Nurminen method|Treatment as a covariate stratified by ECOG PS, presence/absence of liver metastases, hemoglobin and time from completion of most recent chemotherapy||ORR per RECIST 1.1 - PD-L1 Positive Participants||25.7|6.5|0.00049
72540901|NCT01676311|144610840|SUPERIORITY|||||||1||||||A chi-squared test with factors of group (Huperzine A, placebo) and occurrence of neurological side effects (yes, no) were performed. A permutation test was used to assess the effect of Huperzine A on the incidence of these side effects.|Chi-squared test and permutation test|||Neurological side effects statistical analysis||||1.00
72540902|NCT01347879|144610848|SUPERIORITY_OR_OTHER||Difference in least square means|-7.35||||0.006|TWO_SIDED|95.0|-12.5|-2.2|||ANCOVA|Lesion count at baseline and center as covariates||||-2.2|-12.5|0.006
72575582|NCT02256436|144677372|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentages|10.0||||0.00068|TWO_SIDED|95.0|3.9|16.2||One-sided p-value for testing H0: difference in %=0; H1: difference in %\>0|Miettinen & Nurminen method|Treatment as a covariate stratified by ECOG PS, presence/absence of liver metastases, hemoglobin and time from completion of most recent chemotherapy||ORR per RECIST 1.1 - All Participants||16.2|3.9|0.00068
72409847|NCT01639001|144328167|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|4.5026||||0.0263|TWO_SIDED|95.0|0.53|8.47|||Mixed Models Analysis|||Analysis presented for QLQ-C30 constipation. Estimated change from baseline was from a repeated measures mixed-effects model with an intercept term, treatment, visit day and baseline EORTC QLQ-C30 subscale score (intercept and visit day are included as random effects). P-values and confidence intervals are not adjusted for multiplicity.||8.47|0.53|0.0263
72409848|NCT01639001|144328167|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|15.8085|||<|0.0001|TWO_SIDED|95.0|12.94|18.68|||Mixed Models Analysis|||Analysis presented for QLQ-C30 diarrhea. Estimated change from baseline was from a repeated measures mixed-effects model with an intercept term, treatment, visit day and baseline EORTC QLQ-C30 subscale score (intercept and visit day are included as random effects). P-values and confidence intervals are not adjusted for multiplicity.||18.68|12.94|<0.0001
72409849|NCT01639001|144328167|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-7.7449|||<|0.0001|TWO_SIDED|95.0|-11.3|-4.19|||Mixed Models Analysis|||Analysis presented for QLQ-C30 dyspnea. Estimated change from baseline was from a repeated measures mixed-effects model with an intercept term, treatment, visit day and baseline EORTC QLQ-C30 subscale score (intercept and visit day are included as random effects). P-values and confidence intervals are not adjusted for multiplicity.||-4.19|-11.30|<0.0001
72540903|NCT01347879|144610849|SUPERIORITY_OR_OTHER||Difference in least square means|-0.6||||0.8527|TWO_SIDED|95.0|-6.6|5.5|||ANCOVA|Lesion count at baseline and center as covariates||||5.5|-6.6|0.8527
72409850|NCT01639001|144328167|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-6.4915||||0.0001|TWO_SIDED|95.0|-9.82|-3.17|||Mixed Models Analysis|||Analysis presented for QLQ-C30 fatigue. Estimated change from baseline was from a repeated measures mixed-effects model with an intercept term, treatment, visit day and baseline EORTC QLQ-C30 subscale score (intercept and visit day are included as random effects). P-values and confidence intervals are not adjusted for multiplicity.||-3.17|-9.82|0.0001
72409851|NCT01639001|144328167|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-3.6165||||0.2099|TWO_SIDED|95.0|-9.27|2.04|||Mixed Models Analysis|||Analysis presented for QLQ-C30 financial difficulties. Estimated change from baseline was from a repeated measures mixed-effects model with an intercept term, treatment, visit day and baseline EORTC QLQ-C30 subscale score (intercept and visit day are included as random effects). P-values and confidence intervals are not adjusted for multiplicity.||2.04|-9.27|0.2099
72540904|NCT01347879|144610850|SUPERIORITY_OR_OTHER||Difference in least square means|-20.0||||0.0032|TWO_SIDED|95.0|-33.2|-6.8|||ANCOVA|Lesion count at baseline and center as covariates||||-6.8|-33.2|0.0032
72540905|NCT01347879|144610851|SUPERIORITY_OR_OTHER|||||||0.0125||95.0|||||Regression, Logistic|||||||0.0125
72540906|NCT01347879|144610856|SUPERIORITY_OR_OTHER||Difference in least square means|-2.56||||0.7161|TWO_SIDED|95.0|-16.5|11.3|||ANCOVA|Lesion count at baseline and center as covariate||||11.3|-16.5|0.7161
72540907|NCT01223196|144610862|SUPERIORITY_OR_OTHER|||||||0.04|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|Mann-Whitney test was used to test differences in M/I. Statistical Analysis applies to (M/I) between Pioglitazone and Placebo after 6 months.||Mann-Whitney test was used to test differences in whole body insulin sensitivity (M/I) between groups. Treatment-induced changes were examined by Wilcoxon's rank test. Data were analyzed using SPSS 20 (Statistical Package for Social Sciences 20), Chicago, IL, USA).||||0.04
72540908|NCT01223196|144610862|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||Wilcoxon (Mann-Whitney)|Mann-Whitney test was used to test differences in whole body insulin sensitivity (M/I) between groups.||||||0.05
72540909|NCT01223196|144610863|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|Mann-Whitney test was used to test differences in TACE activity in skeletal muscle between groups.||Mann-Whitney test was used to test differences in TACE activity in skeletal muscle between groups. Treatment-induced changes were examined by Wilcoxon's rank test. Data were analyzed using SPSS 20 (Statistical Package for Social Sciences, Chicago, IL, USA).||||<0.05
72540910|NCT01223196|144610863|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0|||||t-test, 2 sided|Statistical Analysis applies toTNF (Tumor Necrosis Factor) alpha converting enzyme (TACE) activity between Pioglitazone and Placebo after 6 months.||Statistical analysis 2 also used 2-sided t-test similar to Statistical analysis -1||||<0.05
72409852|NCT01639001|144328167|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-6.7756||||0.0004|TWO_SIDED|95.0|-10.49|-3.06|||Mixed Models Analysis|||Analysis presented for QLQ-C30 insomnia. Estimated change from baseline was from a repeated measures mixed-effects model with an intercept term, treatment, visit day and baseline EORTC QLQ-C30 subscale score (intercept and visit day are included as random effects). P-values and confidence intervals are not adjusted for multiplicity.||-3.06|-10.49|0.0004
72540911|NCT01223196|144610864|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Wilcoxon (Mann-Whitney)|Mann-Whitney test was used to test differences in Heamoglobin A1c between groups.||Mann-Whitney test was used to test differences Haemoglobin A1C between groups. Treatment-induced changes were examined by Wilcoxon's rank test. Data were analyzed using SPSS 20 (Statistical Package for Social Sciences, Chicago, IL, USA).||||<0.05
72540912|NCT00323271|144610865|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.108||||0.911|TWO_SIDED|95.0|-2.106|1.888|||t-test, 2 sided|||||1.888|-2.106|.911
72540913|NCT00323271|144610866|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.644||||0.32|TWO_SIDED|95.0|-1.058|2.345||Multiple imputation used to account for missing variables; pre-treatment rating and years of MS pain were covariates|ANCOVA|||||2.345|-1.058|0.320
72540914|NCT00068770|144610867|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.5|STANDARD_DEVIATION|1.0||0.82|TWO_SIDED|95.0|1.5|5.5||not adjusted|t-test, 2 sided|||two independent group comparisons||5.5|1.5|0.82
72540915|NCT00068770|144610868|NON_INFERIORITY_OR_EQUIVALENCE|equivalence analysis|Hazard Ratio (HR)|2.7|STANDARD_DEVIATION|1.8||0.11|TWO_SIDED|95.0|1.1|6.3|||Log Rank|||||6.3|1.1|0.11
72575583|NCT02256436|144677373|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.77||||0.07066|TWO_SIDED|95.0|0.53|1.11||One-sided p-value based on stratified log-rank test|Regression, Cox|Treatment as a covariate stratified by ECOG PS, presence/absence of liver metastases, hemoglobin and time from completion of most recent chemotherapy||PFS per mRECIST - Strongly PD-L1 Positive Participants||1.11|0.53|0.07066
72575584|NCT02256436|144677374|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.82||||0.08745|TWO_SIDED|95.0|0.6|1.1||One-sided p-value based on stratified log-rank test|Regression, Cox|Treatment as a covariate stratified by ECOG PS, presence/absence of liver metastases, hemoglobin and time from completion of most recent chemotherapy||PFS per mRECIST - PD-L1 Positive Participants||1.10|0.60|0.08745
72409853|NCT01639001|144328167|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-2.519||||0.0902|TWO_SIDED|95.0|-5.43|0.4|||Mixed Models Analysis|||Analysis presented for QLQ-C30 nausea and vomiting. Estimated change from baseline was from a repeated measures mixed-effects model with an intercept term, treatment, visit day and baseline EORTC QLQ-C30 subscale score (intercept and visit day are included as random effects). P-values and confidence intervals are not adjusted for multiplicity.||0.40|-5.43|0.0902
72409854|NCT01639001|144328167|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-8.4349|||<|0.0001|TWO_SIDED|95.0|-11.42|-5.45|||Mixed Models Analysis|||Analysis presented for QLQ-C30 pain. Estimated change from baseline was from a repeated measures mixed-effects model with an intercept term, treatment, visit day and baseline EORTC QLQ-C30 subscale score (intercept and visit day are included as random effects). P-values and confidence intervals are not adjusted for multiplicity.||-5.45|-11.42|<0.0001
72409855|NCT01639001|144328168|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-4.8547||||0.0039|TWO_SIDED|95.0|-8.15|-1.56|||Mixed Models Analysis|||Analysis presented for QLQ-LC13 alopecia. Estimated change from baseline was from a repeated measures mixed-effects model with an intercept term, treatment, visit day and baseline EORTC QLQ-C30 subscale score (intercept and visit day are included as random effects). P-values and confidence intervals are not adjusted for multiplicity.||-1.56|-8.15|0.0039
72409856|NCT01639001|144328168|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-6.9957||||0.0004|TWO_SIDED|95.0|-10.85|-3.14|||Mixed Models Analysis|||Analysis presented for QLQ-LC13 coughing. Estimated change from baseline was from a repeated measures mixed-effects model with an intercept term, treatment, visit day and baseline EORTC QLQ-C30 subscale score (intercept and visit day are included as random effects). P-values and confidence intervals are not adjusted for multiplicity.||-3.14|-10.85|0.0004
72409857|NCT01639001|144328168|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.5181||||0.7082|TWO_SIDED|95.0|-3.23|2.2|||Mixed Models Analysis|||Analysis presented for QLQ-LC13 dysphagia. Estimated change from baseline was from a repeated measures mixed-effects model with an intercept term, treatment, visit day and baseline EORTC QLQ-C30 subscale score (intercept and visit day are included as random effects). P-values and confidence intervals are not adjusted for multiplicity.||2.20|-3.23|0.7082
72540916|NCT00123487|144610907|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority of the QD schedule relative to the BID schedule was claimed if the lower bound of the 95% CI for difference (QD - BD) was ≥ -12%.|Percent Difference|0.2|||||TWO_SIDED|95.0|-7.8|8.1||||||Primary endpoint was to be assessed at 6-Months: Assuming a 45% MaHR rate in the 70 mg BID participants, the primary efficacy analysis required a total of 540 participants, approximately 270 in each dosing schedule, giving at least 80% power to deduce non-inferiority of the QD schedule relative to the BID schedule if the lower bound of the 95% CI for the difference in MaHR rates (MaHRRQD - MaHRRBID) is greater than -12%.||8.1|-7.8|
72540917|NCT01039584|144610942|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The primary efficacy measure was the proportion of subjects with therapeutic cure at Visit 3/Test-of-Cure. Therapeutic cure was defined as having both a mycological cure and a clinical cure.|Yates continuity correction|1.5|||||TWO_SIDED|90.0|-9.1|12.3|||Wald's method|||||12.3|-9.1|
72540918|NCT01039584|144610943|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The efficacy measure was the proportion of subjects with clinicl cure at Visit 3/Test-of-Cure.|Yates continuity correction|1.5|||||TWO_SIDED|90.0|-7.3|12.8|||Wald's method|||||12.8|-7.3|
72540919|NCT01039584|144610944|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The efficacy measure was the proportion of subjects with mycological cure at Visit 3/Test-of-Cure|Yates continuity correction|1.5||||0.05|TWO_SIDED|90.0|-11.7|9.4|||Wald's method|||||9.4|-11.7|0.05
72540920|NCT03611751|144610945|SUPERIORITY||Odds Ratio (OR)|10.55|||<|0.0001|TWO_SIDED|95.0|6.54|17.0|||Cochran-Mantel-Haenszel|||||17.00|6.54|<0.0001
72540921|NCT03611751|144610946|SUPERIORITY||Odds Ratio (OR)|10.49|||<|0.0001|TWO_SIDED|95.0|6.65|16.55|||Cochran-Mantel-Haenszel|||||16.55|6.65|<0.0001
72540922|NCT03611751|144610947|SUPERIORITY||Odds Ratio (OR)|11.42|||<|0.0001|TWO_SIDED|95.0|5.45|23.93|||Cochran-Mantel-Haenszel|||||23.93|5.45|<0.0001
72540923|NCT03611751|144610947|SUPERIORITY||Odds Ratio (OR)|1.74||||0.0046|TWO_SIDED|95.0|1.18|2.56|||Cochran-Mantel-Haenszel|||||2.56|1.18|0.0046
72540924|NCT03611751|144610948|SUPERIORITY||Odds Ratio (OR)|9.21|||<|0.001|TWO_SIDED|95.0|2.89|29.4|||Cochran-Mantel-Haenszel|||||29.40|2.89|<0.001
72409858|NCT01639001|144328168|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-8.6471|||<|0.0001|TWO_SIDED|95.0|-11.85|-5.44|||Mixed Models Analysis|||Analysis presented for QLQ-LC13 dyspnoea. Estimated change from baseline was from a repeated measures mixed-effects model with an intercept term, treatment, visit day and baseline EORTC QLQ-C30 subscale score (intercept and visit day are included as random effects). P-values and confidence intervals are not adjusted for multiplicity.||-5.44|-11.85|<0.0001
72540925|NCT03611751|144610948|SUPERIORITY||Odds Ratio (OR)|2.55||||0.0051|TWO_SIDED|95.0|1.3|5.0|||Cochran-Mantel-Haenszel|||||5.00|1.30|0.0051
72540926|NCT03611751|144610949|SUPERIORITY||Odds Ratio (OR)|14.44|||<|0.0001|TWO_SIDED|95.0|4.62|45.11|||Cochran-Mantel-Haenszel|||||45.11|4.62|<0.0001
72540927|NCT03611751|144610949|SUPERIORITY||Odds Ratio (OR)|2.85||||0.0002|TWO_SIDED|95.0|1.61|5.03|||Cochran-Mantel-Haenszel|||||5.03|1.61|0.0002
72540928|NCT03611751|144610950|SUPERIORITY||Mean Difference (Net)|-23.6|STANDARD_ERROR_OF_MEAN|1.67|<|0.0001|TWO_SIDED|95.0|-26.9|-20.3|||ANCOVA|||||-20.3|-26.9|<0.0001
72540929|NCT03611751|144610950|SUPERIORITY||Mean Difference (Net)|-7.2|STANDARD_ERROR_OF_MEAN|1.68|<|0.0001|TWO_SIDED|95.0|-10.5|-3.9|||ANCOVA|||||-3.9|-10.5|<0.0001
72540930|NCT03611751|144610951|SUPERIORITY||Odds Ratio (OR)|6.4||||0.0005|TWO_SIDED|95.0|1.94|21.15|||Cochran-Mantel-Haenszel|||||21.15|1.94|0.0005
72540931|NCT03611751|144610951|SUPERIORITY||Odds Ratio (OR)|1.82||||0.0928|TWO_SIDED|95.0|0.89|3.71|||Cochran-Mantel-Haenszel|||||3.71|0.89|0.0928
72540932|NCT03611751|144610952|SUPERIORITY||Odds Ratio (OR)|6.85|||<|0.0001|TWO_SIDED|95.0|4.34|10.81|||Cochran-Mantel-Haenszel|||||10.81|4.34|<0.0001
72540933|NCT03611751|144610952|SUPERIORITY||Odds Ratio (OR)|2.63|||<|0.0001|TWO_SIDED|95.0|1.77|3.91|||Cochran-Mantel-Haenszel|||||3.91|1.77|<0.0001
72540934|NCT03611751|144610953|SUPERIORITY||Odds Ratio (OR)|5.38|||<|0.0001|TWO_SIDED|95.0|3.42|8.47|||Cochran-Mantel-Haenszel|||||8.47|3.42|<0.0001
72540935|NCT03611751|144610954|SUPERIORITY||Odds Ratio (OR)|3.21||||0.0621|TWO_SIDED|95.0|0.88|11.79|||Cochran-Mantel-Haenszel|||||11.79|0.88|0.0621
72540936|NCT03611751|144610955|SUPERIORITY||Odds Ratio (OR)|0.64||||0.6692|TWO_SIDED|95.0|0.06|7.46|||Cochran-Mantel-Haenszel|||||7.46|0.06|0.6692
72540937|NCT03611751|144610955|SUPERIORITY||Odds Ratio (OR)|0.32||||0.3793|TWO_SIDED|95.0|0.02|5.56|||Cochran-Mantel-Haenszel|||||5.56|0.02|0.3793
72409859|NCT01639001|144328168|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-1.2504||||0.1284|TWO_SIDED|95.0|-2.86|0.36|||Mixed Models Analysis|||Analysis presented for QLQ-LC13 haemoptysis. Estimated change from baseline was from a repeated measures mixed-effects model with an intercept term, treatment, visit day and baseline EORTC QLQ-C30 subscale score (intercept and visit day are included as random effects). P-values and confidence intervals are not adjusted for multiplicity.||0.36|-2.86|0.1284
72409860|NCT01639001|144328168|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-4.2363||||0.0265|TWO_SIDED|95.0|-7.98|-0.49|||Mixed Models Analysis|||Analysis presented for QLQ-LC13 pain in arm or shoulder. Estimated change from baseline was from a repeated measures mixed-effects model with an intercept term, treatment, visit day and baseline EORTC QLQ-C30 subscale score (intercept and visit day are included as random effects). P-values and confidence intervals are not adjusted for multiplicity.||-0.49|-7.98|0.0265
72409861|NCT01639001|144328168|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-4.2237||||0.0185|TWO_SIDED|95.0|-7.74|-0.71|||Mixed Models Analysis|||Analysis presented for QLQ-LC13 pain in chest. Estimated change from baseline was from a repeated measures mixed-effects model with an intercept term, treatment, visit day and baseline EORTC QLQ-C30 subscale score (intercept and visit day are included as random effects). P-values and confidence intervals are not adjusted for multiplicity.||-0.71|-7.74|0.0185
72409862|NCT01639001|144328168|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-4.5901||||0.0075|TWO_SIDED|95.0|-7.95|-1.23|||Mixed Models Analysis|||Analysis presented for QLQ-LC13 pain in other parts. Estimated change from baseline was from a repeated measures mixed-effects model with an intercept term, treatment, visit day and baseline EORTC QLQ-C30 subscale score (intercept and visit day are included as random effects). P-values and confidence intervals are not adjusted for multiplicity.||-1.23|-7.95|0.0075
72409863|NCT01639001|144328168|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-1.6732||||0.2848|TWO_SIDED|95.0|-4.74|1.39|||Mixed Models Analysis|||Analysis presented for QLQ-LC13 peripheral neuropathy. Estimated change from baseline was from a repeated measures mixed-effects model with an intercept term, treatment, visit day and baseline EORTC QLQ-C30 subscale score (intercept and visit day are included as random effects). P-values and confidence intervals are not adjusted for multiplicity.||1.39|-4.74|0.2848
72540938|NCT03611751|144610956|SUPERIORITY||Odds Ratio (OR)|1.76||||0.0004|TWO_SIDED|95.0|1.29|2.41|||Cochran-Mantel-Haenszel|||||2.41|1.29|0.0004
72540939|NCT03611751|144610957|SUPERIORITY||Odds Ratio (OR)|2.01|||<|0.0001|TWO_SIDED|95.0|1.45|2.78|||Cochran-Mantel-Haenszel|||||2.78|1.45|<0.0001
72540940|NCT03611751|144610958|SUPERIORITY||||||<|0.0001|||||||Log Rank|||||||<0.0001
72540941|NCT03611751|144610959|SUPERIORITY||Odds Ratio (OR)|2.47|||<|0.0001|TWO_SIDED|95.0|1.78|3.43|||Cochran-Mantel-Haenszel|||||3.43|1.78|<0.0001
72540942|NCT03611751|144610960|SUPERIORITY||Odds Ratio (OR)|2.44|||<|0.0001|TWO_SIDED|95.0|1.78|3.36|||Cochran-Mantel-Haenszel|||||3.36|1.78|<0.0001
72540943|NCT03611751|144610961|SUPERIORITY||Odds Ratio (OR)|2.07||||0.0001|TWO_SIDED|95.0|1.43|3.01|||Cochran-Mantel-Haenszel|||||3.01|1.43|0.0001
72540944|NCT03672396|144610968|OTHER|Paired t-test analysis between baseline and post-testing values from a single group of individuals who completed both testing sessions.|Mean Difference (Final Values)|0.13||||0.378|TWO_SIDED|95.0|-0.2|0.4|||t-test, 2 sided|||||0.4|-0.2|0.378
72540945|NCT03672396|144610969|OTHER|Paired t-test analysis between baseline and post-testing values from a single group of individuals who completed both testing sessions.|Mean Difference (Final Values)|0.35||||0.586|TWO_SIDED|95.0|-1.0|1.7|||t-test, 2 sided|||||1.7|-1.0|0.586
72540946|NCT03672396|144610970|OTHER|Paired t-test analysis between baseline and post-testing values from a single group of individuals who completed both testing sessions.|Mean Difference (Final Values)|-0.25||||0.252|TWO_SIDED|95.0|-0.7|0.2|||t-test, 2 sided|||||0.2|-0.7|0.252
72540947|NCT03672396|144610971|OTHER|Paired t-test analysis between baseline and post-testing values from a single group of individuals who completed both testing sessions.|Mean Difference (Final Values)|-16.3||||0.111|TWO_SIDED|95.0|-36.9|4.3|||t-test, 2 sided|Mean difference calculated as Post - Pre.||||4.3|-36.9|0.111
72540948|NCT03672396|144610972|OTHER|Paired t-test analysis between baseline and post-testing values from a single group of individuals who completed both testing sessions.|Mean Difference (Final Values)|1.4||||0.579|TWO_SIDED|95.0|-4.3|7.2|||t-test, 2 sided|||||7.2|-4.3|0.579
72540949|NCT03672396|144610973|OTHER|Paired t-test analysis between baseline and post-testing values from a single group of individuals who completed both testing sessions.|Mean Difference (Final Values)|-0.1||||0.948|TWO_SIDED|95.0|-3.9|3.7|||t-test, 2 sided|||||3.7|-3.9|0.948
72540950|NCT03672396|144610974|OTHER|Paired t-test analysis between baseline and post-testing values from a single group of individuals who completed both testing sessions.|Mean Difference (Final Values)|-0.2||||0.594|TWO_SIDED|95.0|-1.1|0.7|||t-test, 2 sided|||||0.7|-1.1|0.594
72540951|NCT03672396|144610975|OTHER|Paired t-test analysis between baseline and post-testing values from a single group of individuals who completed both testing sessions.|Mean Difference (Final Values)|-0.8||||0.274|TWO_SIDED|95.0|-2.3|0.7|||t-test, 2 sided|||||0.7|-2.3|0.274
72540952|NCT03672396|144610976|OTHER|Paired t-test analysis between baseline and post-testing values from a single group of individuals who completed both testing sessions.|Mean Difference (Final Values)|1.89||||0.013|TWO_SIDED|95.0|0.48|3.29|||t-test, 2 sided|||||3.29|0.48|0.013
72540953|NCT03672396|144610977|OTHER|Paired t-test analysis between baseline and post-testing values from a single group of individuals who completed both testing sessions.|Mean Difference (Final Values)|4.16||||0.369|TWO_SIDED|95.0|-5.54|13.85|||t-test, 2 sided|||||13.85|-5.54|0.369
72540954|NCT03672396|144610978|OTHER|Paired t-test analysis between baseline and post-testing values from a single group of individuals who completed both testing sessions.|Mean Difference (Final Values)|-0.4||||0.945|TWO_SIDED|95.0|-13.5|12.7|||t-test, 2 sided|||||12.7|-13.5|0.945
72540955|NCT03672396|144610979|OTHER|Paired t-test analysis between baseline and post-testing values from a single group of individuals who completed both testing sessions.|Mean Difference (Final Values)|1.3||||0.42|TWO_SIDED|95.0|-2.0|4.6|||t-test, 2 sided|||||4.6|-2.0|0.420
72540956|NCT03672396|144610980|OTHER|Paired t-test analysis between baseline and post-testing values from a single group of individuals who completed both testing sessions.|Mean Difference (Final Values)|-0.6||||0.941|TWO_SIDED|95.0|-16.9|15.8|||t-test, 2 sided|||||15.8|-16.9|0.941
72540957|NCT03672396|144610981|OTHER|Paired t-test analysis between baseline and post-testing values from a single group of individuals who completed both testing sessions.|Mean Difference (Final Values)|2.3||||0.203|TWO_SIDED|95.0|-1.4|5.9|||t-test, 2 sided|||||5.9|-1.4|0.203
72540958|NCT03672396|144610982|OTHER|Paired t-test analysis between baseline and post-testing values from a single group of individuals who completed both testing sessions.|Mean Difference (Final Values)|1.3||||0.057|TWO_SIDED|95.0|-0.04|2.6|||t-test, 2 sided|||||2.6|-0.04|0.057
72540959|NCT03672396|144610983|OTHER|Paired t-test analysis between baseline and post-testing values from a single group of individuals who completed both testing sessions.|Mean Difference (Final Values)|0.1||||0.809|TWO_SIDED|95.0|-1.0|1.3|||t-test, 2 sided|||||1.3|-1.0|0.809
72540960|NCT03672396|144610984|OTHER|Paired t-test analysis between baseline and post-testing values from a single group of individuals who completed both testing sessions.|Mean Difference (Final Values)|0.4||||0.191|TWO_SIDED|95.0|-0.3|1.1|||t-test, 2 sided|||||1.1|-0.3|0.191
72540961|NCT03672396|144610985|OTHER|Paired t-test analysis between baseline and post-testing values from a single group of individuals who completed both testing sessions.|Mean Difference (Final Values)|0.5||||0.237|TWO_SIDED|95.0|-0.3|1.3|||t-test, 2 sided|||||1.3|-0.3|0.237
72540962|NCT02441179|144610986|SUPERIORITY_OR_OTHER|||||||0.006|TWO_SIDED||||||Kruskal-Wallis|||||||0.006
72540963|NCT02441179|144610987|SUPERIORITY_OR_OTHER|||||||0.012|TWO_SIDED||||||Kruskal-Wallis|||||||0.012
72540964|NCT02441179|144610988|SUPERIORITY_OR_OTHER|||||||0.16|TWO_SIDED||||||Kruskal-Wallis|||||||0.16
72540965|NCT02441179|144610989|SUPERIORITY_OR_OTHER|||||||0.57|TWO_SIDED||||||Chi-squared|||||||0.57
72540966|NCT02441179|144610990|SUPERIORITY_OR_OTHER|||||||0.14|TWO_SIDED||||||Chi-squared|||||||0.14
72540967|NCT02441179|144610991|SUPERIORITY_OR_OTHER|||||||0.43|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.43
72540968|NCT02441179|144610992|SUPERIORITY_OR_OTHER|||||||0.55|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.55
72540969|NCT02139306|144611085|SUPERIORITY||Mean Difference (Net)|0.597|STANDARD_ERROR_OF_MEAN|0.957||0.5336|TWO_SIDED|95.0|-1.2881|2.4813|||Mixed-model, repeated-measures|||||2.4813|-1.2881|0.5336
72540970|NCT02139306|144611086|SUPERIORITY||Rate ratio|0.8567|STANDARD_ERROR_OF_MEAN|0.1577||0.4008|TWO_SIDED|95.0|0.5973|1.2288|||Negative binomial regression|||||1.2288|0.5973|0.4008
72540971|NCT02139306|144611087|SUPERIORITY||Mean Difference (Net)|0.272|STANDARD_ERROR_OF_MEAN|1.93||0.8881|TWO_SIDED|95.0|-3.5292|4.0731|||Mixed-model, repeated measures|||||4.0731|-3.5292|0.8881
72540972|NCT02139306|144611088|SUPERIORITY||Mean Difference (Net)|-0.065|STANDARD_ERROR_OF_MEAN|0.1312||0.6208|TWO_SIDED|95.0|-0.3233|0.1934|||Mixed-model, repeated measures|||||0.1934|-0.3233|0.6208
72409864|NCT01639001|144328168|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-2.398||||0.0296|TWO_SIDED|95.0|-4.56|-0.24|||Mixed Models Analysis|||Analysis presented for QLQ-LC13 sore mouth. Estimated change from baseline was from a repeated measures mixed-effects model with an intercept term, treatment, visit day and baseline EORTC QLQ-C30 subscale score (intercept and visit day are included as random effects). P-values and confidence intervals are not adjusted for multiplicity.||-0.24|-4.56|0.0296
72540973|NCT03273257|144611117|SUPERIORITY|||||||0.139|||||||2-sample Wilcoxon rank sum test|||The null hypothesis is that there is no difference between the treatment groups in percent change from baseline in PVR immediately before PEA.||||0.139
72627675|NCT00565409|144783946|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.4|||<|0.0001|TWO_SIDED|95.0|-1.7|-1.1||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 48||-1.1|-1.7|<0.0001
72540974|NCT03033069|144611153|SUPERIORITY||Least Squares (LS ) Mean Difference|-5.99|||=|0.0021|TWO_SIDED|95.0|-9.79|-2.19|||Mixed Model Repeated Measures (MMRM)|||MMRM analysis with an unstructured (UN) variance covariance structure was performed. The model included fixed class-effect terms for treatment, trial site, type of trauma (combat related Yes/No), visit week, and an interaction term of treatment by visit week and included the interaction term of baseline values of CAPS-5 total score by visit week as a covariate.||-2.19|-9.79|=0.0021
72540975|NCT03033069|144611153|SUPERIORITY||LS Mean Difference|-1.74|||=|0.3868|TWO_SIDED|95.0|-5.7|2.22|||MMRM|||MMRM analysis with an UN variance covariance structure was performed. The model included fixed class-effect terms for treatment, trial site, type of trauma (combat related Yes/No), visit week, and an interaction term of treatment by visit week and included the interaction term of baseline values of CAPS-5 total score by visit week as a covariate.||2.22|-5.70|=0.3868
72540976|NCT03033069|144611153|SUPERIORITY||LS Mean Difference|-0.91|||=|0.6399|TWO_SIDED|95.0|-4.74|2.92|||MMRM|||MMRM analysis with an UN variance covariance structure was performed. The model included fixed class-effect terms for treatment, trial site, type of trauma (combat related Yes/No), visit week, and an interaction term of treatment by visit week and included the interaction term of baseline values of CAPS-5 total score by visit week as a covariate.||2.92|-4.74|=0.6399
72540977|NCT03033069|144611153|SUPERIORITY||LS Mean Difference|-5.08|||=|0.0106|TWO_SIDED|95.0|-8.96|-1.2|||MMRM|||MMRM analysis with an UN variance covariance structure was performed. The model included fixed class-effect terms for treatment, trial site, type of trauma (combat related Yes/No), visit week, and an interaction term of treatment by visit week and included the interaction term of baseline values of CAPS-5 total score by visit week as a covariate.||-1.20|-8.96|=0.0106
72540978|NCT03033069|144611153|SUPERIORITY||LS Mean Difference|-4.24|||=|0.0384|TWO_SIDED|95.0|-8.26|-0.23|||MMRM|||MMRM analysis with an UN variance covariance structure was performed. The model included fixed class-effect terms for treatment, trial site, type of trauma (combat related Yes/No), visit week, and an interaction term of treatment by visit week and included the interaction term of baseline values of CAPS-5 total score by visit week as a covariate.||-0.23|-8.26|=0.0384
72540979|NCT00500656|144611157|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|3.475|||<|0.001|TWO_SIDED|95.0|1.901|6.355|||The Wilcoxon version of the log rank|The median time to onset was calculated using Kaplan Meier methodology. The Wilcoxon version of the log rank test of SAS was used||||6.355|1.901|< 0.001
72540980|NCT00500656|144611158|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||The Wilcoxon version of the log rank|The median time to almost complete symptom relief was calculated using Kaplan Meier methodology.The Wilcoxon version of the log rank test SAS was used||||||< 0.001
72540981|NCT01791127|144611186|SUPERIORITY|The primary endpoint 1 hypothesis was evaluated by performing an exact, binomial test comparing a binomial proportion (AEFR at 12 months) to 94.0%, with Type I error (alpha) or 0.025 and power of 80%.|||||<|0.0001|||||||Exact, binomial|||||||<0.0001
72409865|NCT01639001|144328169|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|3.9136||||0.0123|TWO_SIDED|95.0|0.85|6.98|||Mixed Models Analysis|||From a repeated measures mixed-effects model with an intercept term, treatment, visit day and baseline EQ-5D VAS subscale score (intercept and visit day are included as random effects). P-values and confidence intervals are not adjusted for multiplicity.||6.98|0.85|0.0123
72540982|NCT01791127|144611187|SUPERIORITY||||||<|0.0001|||||||Exact, binomial|||The primary endpoint 2 hypothesis was evaluated by performing an exact, binomial test comparing a binomial proportion (AEFR at 12 months) to 94.0%, with Type I error (alpha) or 0.025 and power of 80%.||||<0.0001
72540983|NCT01791127|144611188|SUPERIORITY||||||<|0.0001|||||||Exact, binomial|||The primary endpoint 3 hypothesis was evaluated by performing an exact, binomial test comparing a binomial proportion (successful sensing and pacing rate at 12 months) to 97.0%, with Type I error (alpha) or 0.025 and power of 80%.||||<0.0001
72540984|NCT01791127|144611189|SUPERIORITY|||||||||||||||||The primary endpoint 4 hypothesis was evaluated by performing an exact, binomial test comparing a binomial proportion (AEFR at 5 years) to 92.5%, with Type I error (alpha) or 0.025 and power of 80%.|On April 15, 2019, BIOTRONIK received FDA approval to transition the ongoing SIELLO Post Approval Registry to a new EP PASSION real-world data methodology. As of study closure, the number of subjects with complete data required to perform the hypothesis test was not met. Therefore, this outcome measure was not analyzed.|||
72540985|NCT03471182|144611227|SUPERIORITY|||||||0.035||||||Primary hypothesis of a group difference (i.e., CUD vs HHC-PET participants) in mGluR5 availability was assessed as the significance level of the fixed-effect of group at a threshold of p\<0.05.|Mixed Models Analysis|||Outcome Measure Data were tested using a single linear mixed effects model. The 9 regions of interest (i.e., all 9 Rows of the Outcome Measure Data) were included in the model as a within-subjects factor for the fixed-effect of region. Group (i.e., CUD, HHC-PET) was included in the model as a between-subjects factor for the fixed-effect of group. The model also included the region-by-group interaction term and a factor to model the random-effect of participant.||||0.035
72540986|NCT03471182|144611228|SUPERIORITY|Outcome Measure Data were tested using a single linear mixed effects model. The 4 brain networks of interest (i.e., all 4 Rows of the Outcome Measure Data) were included in the model as a within-subjects factor for the fixed-effect of network. Group (i.e., CUD, HC-MRI) was included in the model as a between-subjects factor for the fixed-effect of group. The model also included the network-by-group interaction term and a factor to model the random-effect of participant.||||||0.024||||||Primary hypothesis of group differences (i.e., CUD vs HC-MRI participants) in functional brain network engagement was assessed as the significance level of the fixed-effect of group at a threshold of p\<0.05.|Mixed Models Analysis|||||||0.024
72540987|NCT03471182|144611229|SUPERIORITY|||||||0.87||||||Primary hypothesis of group differences (i.e., CUD vs HC-MRI participants) in fALFF was assessed as the significance level of the fixed-effect of group at a threshold of p\<0.05.|Mixed Models Analysis|||Outcome Measure Data were tested using a single linear mixed effects model. The 5 brain networks of interest (i.e., all 5 Rows of the Outcome Measure Data) were included in the model as a within-subjects factor for the fixed-effect of network. Group (i.e., CUD, HC-MRI) was included in the model as a between-subjects factor for the fixed-effect of group. The model also included the network-by-group interaction term and a factor to model the random-effect of participant.||||0.870
72540988|NCT04440163|144611231|NON_INFERIORITY|95% CI for the difference in percentage of participants was calculated based on Miettinen and Nurminen. If the lower limit of the 2-sided 95% CI for the difference in percentage of participants was greater than (\>) minus (-)10 percent (%), the non-inferiority was concluded.|Difference in percentage of participants|2.5|||||TWO_SIDED|95.0|-0.2|6.0|||Based on Miettinen and Nurminen method.|||MenA||6.0|-0.2|
72540989|NCT04440163|144611231|NON_INFERIORITY|95% CI for the difference in percentage of participants was calculated based on Miettinen and Nurminen. If the lower limit of the 2-sided 95% CI for the difference in percentage of participants was \> -10%, the non-inferiority was concluded.|Difference in percentage of participants|41.0|||||TWO_SIDED|95.0|34.4|47.5||||||MenC||47.5|34.4|
72540990|NCT04440163|144611231|NON_INFERIORITY|95% CI for the difference in percentage of participants was calculated based on Miettinen and Nurminen. If the lower limit of the 2-sided 95% CI for the difference in percentage of participants was \> -10%, the non-inferiority was concluded.|Difference in percentage of participants|24.3|||||TWO_SIDED|95.0|18.8|30.4||||||MenW||30.4|18.8|
72540991|NCT04440163|144611231|NON_INFERIORITY|95% CI for the difference in percentage of participants was calculated based on Miettinen and Nurminen. If the lower limit of the 2-sided 95% CI for the difference in percentage of participants was \> -10%, the non-inferiority was concluded.|Difference in percentage of participants|23.8|||||TWO_SIDED|95.0|18.0|30.1||||||MenY||30.1|18.0|
72540992|NCT04440163|144611232|NON_INFERIORITY|95% CI for the difference in percentage of participants was calculated based on Miettinen and Nurminen. If the lower limit of the 2-sided 95% CI for the difference in percentage of participants was \> -10%, the non-inferiority was concluded.|Difference in percentage of participants|-3.2|||||TWO_SIDED|95.0|-6.5|0.5||||||MenA||0.5|-6.5|
72540993|NCT04440163|144611232|NON_INFERIORITY|95% CI for the difference in percentage of participants was calculated based on Miettinen and Nurminen. If the lower limit of the 2-sided 95% CI for the difference in percentage of participants was \> -10%, the non-inferiority was concluded.|Difference in percentage of participants|-0.9|||||TWO_SIDED|95.0|-4.6|3.3||||||MenC||3.3|-4.6|
72540994|NCT04440163|144611232|NON_INFERIORITY|95% CI for the difference in percentage of participants was calculated based on Miettinen and Nurminen. If the lower limit of the 2-sided 95% CI for the difference in percentage of participants was \> -10%, the non-inferiority was concluded.|Difference in percentage of participants|0.7|||||TWO_SIDED|95.0|-2.2|4.3||||||MenW||4.3|-2.2|
72540995|NCT04440163|144611232|NON_INFERIORITY|95% CI for the difference in percentage of participants was calculated based on Miettinen and Nurminen. If the lower limit of the 2-sided 95% CI for the difference in percentage of participants was \> -10%, the non-inferiority was concluded.|Difference in percentage of participants|-0.7|||||TWO_SIDED|95.0|-4.6|3.8||||||MenY||3.8|-4.6|
72409866|NCT01639001|144328170|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.0425||||0.032|TWO_SIDED|95.0|0.0|0.08|||Mixed Models Analysis|||From a repeated measures mixed-effects model with an intercept term, treatment, visit day and baseline EQ-5D Index score (intercept and visit day are included as random effects). P-values and confidence intervals are not adjusted for multiplicity.||0.08|0.00|0.0320
72409867|NCT01639001|144328172|SUPERIORITY_OR_OTHER_LEGACY||Overall percent agreement|0.934|||||TWO_SIDED|95.0|0.914|0.949|||||95% CI for agreement rate is calculated by the Wilson (Score) Confidence Limit method with alpha=0.05|||0.949|0.914|
72540996|NCT04440163|144611233|NON_INFERIORITY|95% CI for the difference in percentage of participants was calculated based on Miettinen and Nurminen. If the lower limit of the 2-sided 95% CI for the difference in percentage of participants was \> -10%, the non-inferiority was concluded.|Difference in percentage of participants|9.6|||||TWO_SIDED|95.0|4.2|15.2||||||||15.2|4.2|
72540997|NCT04440163|144611234|NON_INFERIORITY|95% CI for the difference in percentage of participants was calculated based on Miettinen and Nurminen. If the lower limit of the 2-sided 95% CI for the difference in percentage of participants was \> -10%, the non-inferiority was concluded.|Difference in percentage of participants|4.0|||||TWO_SIDED|95.0|-0.7|8.9||||||A22||8.9|-0.7|
72540998|NCT04440163|144611234|NON_INFERIORITY|95% CI for the difference in percentage of participants was calculated based on Miettinen and Nurminen. If the lower limit of the 2-sided 95% CI for the difference in percentage of participants was \> -10%, the non-inferiority was concluded.|Difference in percentage of participants|1.4|||||TWO_SIDED|95.0|-1.0|4.3||||||A56||4.3|-1.0|
72540999|NCT04440163|144611234|NON_INFERIORITY|95% CI for the difference in percentage of participants was calculated based on Miettinen and Nurminen. If the lower limit of the 2-sided 95% CI for the difference in percentage of participants was \> -10%, the non-inferiority was concluded.|Difference in percentage of participants|10.9|||||TWO_SIDED|95.0|5.2|16.6||||||B24||16.6|5.2|
72541000|NCT04440163|144611234|NON_INFERIORITY|95% CI for the difference in percentage of participants was calculated based on Miettinen and Nurminen. If the lower limit of the 2-sided 95% CI for the difference in percentage of participants was \> -10%, the non-inferiority was concluded.|Difference in percentage|7.3|||||TWO_SIDED|95.0|2.9|11.9||||||B44||11.9|2.9|
72541001|NCT04440163|144611266|NON_INFERIORITY|95% CI for the difference in percentage of participants was calculated based on Miettinen and Nurminen. If the lower limit of the 2-sided 95% CI for the difference in percentage of participants was \> -10%, the non-inferiority was concluded.|Difference in percentage of participants|1.7|||||TWO_SIDED|95.0|-1.0|5.3||||||MenA||5.3|-1.0|
72541002|NCT04440163|144611266|NON_INFERIORITY|95% CI for the difference in percentage of participants was calculated based on Miettinen and Nurminen. If the lower limit of the 2-sided 95% CI for the difference in percentage of participants was \> -10%, the non-inferiority was concluded.|Difference in percentage of participants|10.5|||||TWO_SIDED|95.0|3.0|17.9||||||MenC||17.9|3.0|
72541003|NCT04440163|144611266|NON_INFERIORITY|95% CI for the difference in percentage of participants was calculated based on Miettinen and Nurminen. If the lower limit of the 2-sided 95% CI for the difference in percentage of participants was \> -10%, the non-inferiority was concluded.|Difference in percentage of participants|6.3|||||TWO_SIDED|95.0|-0.1|13.1||||||MenW||13.1|-0.1|
72369247|NCT00611026|144248561|SUPERIORITY_OR_OTHER|||||||0.0012|TWO_SIDED|||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with terms for country and treatment and ranked baseline value as a covariate.||Treatment difference fesoterodine vs placebo at Week 1.||||0.0012
72369248|NCT00611026|144248561|SUPERIORITY_OR_OTHER|||||||0.0205|TWO_SIDED|||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with terms for country and treatment and ranked baseline value as a covariate.||Treatment difference Tolterodine ER vs placebo at Week 1.||||0.0205
72541004|NCT04440163|144611266|NON_INFERIORITY|95% CI for the difference in percentage of participants was calculated based on Miettinen and Nurminen. If the lower limit of the 2-sided 95% CI for the difference in percentage of participants was \> -10%, the non-inferiority was concluded.|Difference in percentage of participants|11.4|||||TWO_SIDED|95.0|5.0|18.2||||||MenY||18.2|5.0|
72541005|NCT04440163|144611267|NON_INFERIORITY|95% CI for the difference in percentage of participants was calculated based on Miettinen and Nurminen. If the lower limit of the 2-sided 95% CI for the difference in percentage of participants was \> -10%, the non-inferiority was concluded.|Difference in percentage of participants|-2.2|||||TWO_SIDED|95.0|-5.2|1.4||||||MenA||1.4|-5.2|
72541006|NCT04440163|144611267|NON_INFERIORITY|95% CI for the difference in percentage of participants was calculated based on Miettinen and Nurminen. If the lower limit of the 2-sided 95% CI for the difference in percentage of participants was \> -10%, the non-inferiority was concluded.|Difference in percentage of participants|-1.3|||||TWO_SIDED|95.0|-4.9|2.9||||||MenC||2.9|-4.9|
72541007|NCT04440163|144611267|NON_INFERIORITY|95% CI for the difference in percentage of participants was calculated based on Miettinen and Nurminen. If the lower limit of the 2-sided 95% CI for the difference in percentage of participants was \> -10%, the non-inferiority was concluded.|Difference in percentage of participants|1.0|||||TWO_SIDED|95.0|-1.6|4.6||||||MenW||4.6|-1.6|
72369249|NCT00611026|144248561|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with terms for country and treatment and ranked baseline value as a covariate.||Treatment difference fesoterodine vs placebo at Week 4.||||<0.0001
72541008|NCT04440163|144611267|NON_INFERIORITY|95% CI for the difference in percentage of participants was calculated based on Miettinen and Nurminen. If the lower limit of the 2-sided 95% CI for the difference in percentage of participants was \> -10%, the non-inferiority was concluded.|Difference in percentage of participants|0.6|||||TWO_SIDED|95.0|-3.0|5.0||||||MenY||5.0|-3.0|
72541009|NCT02229487|144611268|OTHER|||||||0.209|||||||Wilcoxon (Mann-Whitney)|||||||0.209
72541010|NCT01954082|144611272|SUPERIORITY||Risk Ratio (RR)|1.41||||0.0095|TWO_SIDED|95.0|1.08|1.83||A-priori threshold for statistical significance at 0.05 was specified.|Robust Poisson|Model adjusted for strata defined by center and gestational age.|In the risk ratio, the numerator represents the Inositol arm and the denominator represents the placebo arm. (RR\>1 implies that the risk of mortality and/or severe ROP is greater in the Inositol group compared to the Placebo group).|The null hypothesis is there is no treatment effect on the development of severe ROP and mortality.||1.83|1.08|0.0095
72575585|NCT02256436|144677375|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.86||||0.05328|TWO_SIDED|95.0|0.71|1.04||One-sided p-value based on stratified log-rank test|Regression, Cox|Treatment as a covariate stratified by ECOG PS, presence/absence of liver metastases, hemoglobin and time from completion of most recent chemotherapy||PFS per mRECIST - All Participants||1.04|0.71|0.05328
72369250|NCT00611026|144248561|SUPERIORITY_OR_OTHER|||||||0.0038|TWO_SIDED|||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with terms for country and treatment and ranked baseline value as a covariate.||Treatment difference Tolterodine ER vs placebo at Week 4.||||0.0038
72575586|NCT02256436|144677376|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentages|21.5||||9e-05|TWO_SIDED|95.0|10.1|34.2||One-sided p-value for testing H0: difference in %=0; H1: difference in %\>0|Miettinen & Nurminen method|Treatment as a covariate stratified by ECOG PS, presence/absence of liver metastases, hemoglobin and time from completion of most recent chemotherapy||ORR per mRECIST - Strongly PD-L1 Positive Participants||34.2|10.1|0.00009
72575587|NCT02256436|144677377|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentages|21.0||||2e-05|TWO_SIDED|95.0|11.1|31.5||One-sided p-value for testing H0: difference in %=0; H1: difference in %\>0|Miettinen & Nurminen method|Treatment as a covariate stratified by ECOG PS, presence/absence of liver metastases, hemoglobin and time from completion of most recent chemotherapy||ORR per mRECIST - PD-L1 Positive Participants||31.5|11.1|0.00002
72575588|NCT02256436|144677378|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentages|13.8||||1e-05|TWO_SIDED|95.0|7.4|20.3||One-sided p-value for testing H0: difference in %=0; H1: difference in %\>0|Miettinen & Nurminen method|Treatment as a covariate stratified by ECOG PS, presence/absence of liver metastases, hemoglobin and time from completion of most recent chemotherapy||ORR per mRECIST - All Participants||20.3|7.4|0.00001
72575589|NCT03898908|144677421|SUPERIORITY|||||||0.015||||||pValues below 0.05 are considered statistically significant|Wilcoxon (Mann-Whitney)|||Comparison between baseline and Week 8||||0.015
72575590|NCT03898908|144677422|SUPERIORITY|||||||0.754||||||pValues below 0.05 are considered statistically significant|Wilcoxon (Mann-Whitney)|||Comparison between baseline and W24||||0.754
72575591|NCT00468650|144677424|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|10.96|STANDARD_DEVIATION|5.19|<|0.001||95.0|10.0|11.93||"Statistical significance will be declared if the p-value is \<0.05.~Change from Baseline: Week 6 (LOCF) minus Baseline"|t-test, 2 sided|single sample t-test||Primary hypothesis to be tested is whether there is a significant improvement in the IIEF EF domain at the end of the 100 mg period, as compared to the baseline (Week 0) score. Sample size (N=115) provides more than 90% power to detect a change from baseline of 10 in the primary efficacy variable, assuming a standard deviation of 9, using the two-sided, single-sample t-test with significance level (alpha) of 0.05.||11.93|10.00|<0.001
72575592|NCT00468650|144677425|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|7.14|STANDARD_DEVIATION|5.21|<|0.001||95.0|6.17|8.11||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 2 minus baseline||8.11|6.17|<0.001
72575593|NCT00468650|144677425|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|10.57|STANDARD_DEVIATION|5.43|<|0.001||95.0|9.56|11.59||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 4 minus baseline||11.59|9.56|<0.001
72575594|NCT00468650|144677425|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|10.93|STANDARD_DEVIATION|5.26|<|0.001||95.0|9.93|11.92||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 minus baseline||11.92|9.93|<0.001
72575595|NCT00468650|144677425|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|10.95|STANDARD_DEVIATION|5.21|<|0.001||95.0|9.97|11.92||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 endpoint minus baseline||11.92|9.97|<0.001
72575596|NCT00468650|144677426|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|3.48|STANDARD_DEVIATION|3.97|<|0.001||95.0|2.74|4.23||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 4 minus Week 2||4.23|2.74|<0.001
72575597|NCT00468650|144677426|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|3.88|STANDARD_DEVIATION|4.38|<|0.001||95.0|3.05|4.71||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 minus Week 2 For the secondary outcome, the change in IIEF-EF domain from the end of 50 mg period (Week 2) to the end of 100 mg period (Week 6), the sample size (N=115) provides more than 80% power to detect a mean change of 1.75 points, assuming a standard deviation of 6, using the two-sided, single sample t-test with significance level (alpha) of 0.05||4.71|3.05|<0.001
72575598|NCT00468650|144677426|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|3.86|STANDARD_DEVIATION|4.35|<|0.001||95.0|3.04|4.67||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 LOCF minus Week 2 For the secondary outcome, the change in IIEF-EF domain from the end of 50 mg period (Week 2) to the end of 100 mg period (Week 6), the sample size (N=115) provides more than 80% power to detect a mean change of 1.75 points, assuming a standard deviation of 6, using the two-sided, single sample t-test with significance level (alpha) of 0.05||4.67|3.04|<0.001
72575599|NCT00468650|144677426|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|3.86|STANDARD_DEVIATION|4.35|<|0.001||95.0|3.04|4.67||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 Endpoint minus Week 2 For the secondary outcome, the change in IIEF-EF domain from the end of 50 mg period (Week 2) to the end of 100 mg period (Week 6), the sample size (N=115) provides more than 80% power to detect a mean change of 1.75 points, assuming a standard deviation of 6, using the two-sided, single sample t-test with significance level (alpha) of 0.05||4.67|3.04|<0.001
72575600|NCT00468650|144677427|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|1.89|STANDARD_DEVIATION|2.4|<|0.001||95.0|1.45|2.34||p-value not adjusted for multiple comparisons. Threshold for significance p\<0.05|t-test, 2 sided|single sample t-test||Week 2 minus Baseline||2.34|1.45|<0.001
72541011|NCT01954082|144611273|SUPERIORITY||Risk Ratio (RR)|1.03||||0.6599|TWO_SIDED|95.0|0.91|1.16||A-priori threshold for statistical significance at 0.05 was specified.|Robust Poisson regression|Model adjusted for strata defined by center and gestational age.|In the risk ratio, the numerator represents the Inositol arm and the denominator represents the placebo arm. (RR\>1 implies that the risk of BPD is greater in the Inositol group compared to the Placebo group).|The null hypothesis is there is no treatment effect on the incidence of BPD.||1.16|0.91|0.6599
72541012|NCT01954082|144611274|SUPERIORITY||Risk Ratio (RR)|1.05||||0.3883|TWO_SIDED|95.0|0.94|1.17||A-priori threshold for statistical significance at 0.05 was specified.|Robust Poisson regression|Model adjusted for strata defined by center and gestational age.||The null hypothesis is there is no treatment effect on the incidence of BPD or on mortality due to BDP.||1.17|0.94|0.3883
72541013|NCT01954082|144611275|SUPERIORITY||Risk Ratio (RR)|1.53||||0.0306|TWO_SIDED|95.0|1.03|2.25||A-priori threshold for statistical significance at 0.05 was specified.|Robust Poisson regression|Model adjusted for strata defined by center and gestational age.|In the risk ratio, the numerator represents the Inositol arm and the denominator represents the placebo arm. (RR\>1 implies that the risk of mortality prior to ROP endpoint is greater in the Inositol group compared to the Placebo group).|The null hypothesis is there is no treatment effect on survival to ROP endpoint.||2.25|1.03|0.0306
72541014|NCT01954082|144611276|SUPERIORITY||Risk Ratio (RR)|1.02||||0.7464|TWO_SIDED|95.0|0.91|1.14||A-priori threshold for statistical significance at 0.05 was specified.|Robust Poisson regression|Model adjusted for strata defined by center and gestational age.||The null hypothesis is there is no treatment effect on the incidence of ROP||1.14|0.91|0.7464
72541015|NCT01954082|144611277|SUPERIORITY||Risk Ratio (RR)|0.98||||0.7598|TWO_SIDED|95.0|0.83|1.14||A-priori threshold for statistical significance at 0.05 was specified.|Robust Poisson regression|Model adjusted for strata defined by center and gestational age.|In the risk ratio, the numerator represents the Inositol arm and the denominator represents the placebo arm. (RR\>1 implies that the risk of Type 2 ROP or more severe ROP is greater in the Inositol group compared to the Placebo group).|The null hypothesis is there is no treatment effect on the incidence of Type 2 ROP or more severe ROP.||1.14|0.83|0.7598
72541016|NCT01954082|144611278|SUPERIORITY||Risk Ratio (RR)|1.04||||0.8133|TWO_SIDED|95.0|0.74|1.48||A-priori threshold for statistical significance at 0.05 was specified.|Robust Poisson regression|Model adjusted for strata defined by center and gestational age.|In the risk ratio, the numerator represents the Inositol arm and the denominator represents the placebo arm. (RR\>1 implies that the risk of severe IVH is greater in the Inositol group compared to the Placebo group).|The null hypothesis is there is no treatment effect on the incidence severe IVH.||1.48|0.74|0.8133
72541017|NCT01453374|144611319|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Fisher Exact|||||||>0.05
72541018|NCT01453374|144611320|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Fisher Exact|||||||>0.05
72541019|NCT01453374|144611321|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Fisher Exact|||||||<0.05
72541020|NCT01453374|144611327|SUPERIORITY_OR_OTHER||||||<|0.1|TWO_SIDED||||||Fisher Exact|||||||<0.10
72541021|NCT05180630|144611329|OTHER|||||||0.012||||||When p-value is adjusted for multiple comparisons, the level of statistical significance must be \</= to 0.01666667 (.05/3). Comparisons were total mean scores for Open dome condition, Vented dome condition, and Custom earmolds with dynamic venting|ANOVA|||Treatment order was not analyzed. A repeated measures ANOVA was performed to compare the effect of the coupling conditions on sound quality ratings for streamed music, but there was no analysis between groups.||||0.012
72409868|NCT01639001|144328172|SUPERIORITY_OR_OTHER_LEGACY||Kappa|0.847|||||TWO_SIDED|95.0|0.8065|0.8875|||||Kappa coefficient is a statistic which measures inter-rater agreement for qualitative (categorical) items.|||0.8875|0.8065|
72575601|NCT00468650|144677427|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|2.46|STANDARD_DEVIATION|2.32|<|0.001||95.0|2.02|2.89||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 4 minus Baseline||2.89|2.02|<0.001
72575602|NCT00468650|144677427|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|2.59|STANDARD_DEVIATION|2.44|<|0.001||95.0|2.13|3.05||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 minus Baseline||3.05|2.13|<0.001
72575603|NCT00468650|144677427|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|2.63|STANDARD_DEVIATION|2.45|<|0.001||95.0|2.17|3.08||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 LOCF minus Baseline||3.08|2.17|<0.001
72575604|NCT00468650|144677427|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|2.59|STANDARD_DEVIATION|2.42|<|0.001||95.0|2.14|3.04||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 Endpoint minus Baseline||3.04|2.14|<0.001
72575605|NCT00468650|144677428|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.61|STANDARD_DEVIATION|1.51|<|0.001||95.0|0.32|0.89||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 4 minus Week 2||0.89|0.32|<0.001
72575606|NCT00468650|144677428|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.75|STANDARD_DEVIATION|1.46|<|0.001||95.0|0.47|1.02||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 minus Week 2||1.02|0.47|<0.001
72575607|NCT00468650|144677428|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.74|STANDARD_DEVIATION|1.45|<|0.001||95.0|0.47|1.01||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 LOCF minus Week 2||1.01|0.47|<0.001
72575608|NCT00468650|144677428|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.74|STANDARD_DEVIATION|1.45|<|0.001||95.0|0.47|1.01||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 Endpoint minus Week 2||1.01|0.47|<0.001
72575609|NCT00468650|144677429|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|1.43|STANDARD_DEVIATION|1.87|<|0.001||95.0|1.09|1.78||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 2 minus Baseline||1.78|1.09|<0.001
72575610|NCT00468650|144677429|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|2.0|STANDARD_DEVIATION|1.86|<|0.001||95.0|1.65|2.35||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 4 minus Baseline||2.35|1.65|<0.001
72575611|NCT00468650|144677429|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|2.25|STANDARD_DEVIATION|1.91|<|0.001||95.0|1.89|2.62||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 minus Baseline||2.62|1.89|<0.001
72575612|NCT00468650|144677429|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|2.26|STANDARD_DEVIATION|1.94|<|0.001||95.0|1.9|2.62||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 LOCF minus Baseline||2.62|1.90|<0.001
72575613|NCT00468650|144677429|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|2.28|STANDARD_DEVIATION|1.93|<|0.001||95.0|1.91|2.64||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 Endpoint minus Baseline||2.64|1.91|<0.001
72575614|NCT00468650|144677430|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.55|STANDARD_DEVIATION|1.41|<|0.001||95.0|0.29|0.82||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 4 minus Week 2||0.82|0.29|<0.001
72575615|NCT00468650|144677430|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.81|STANDARD_DEVIATION|1.47|<|0.001||95.0|0.53|1.09||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 minus Week 2||1.09|0.53|<0.001
72627676|NCT00565409|144783946|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.18||||0.3129|TWO_SIDED|95.0|-0.5|0.2||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 48||0.2|-0.5|0.3129
72627677|NCT00565409|144783946|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.23|||<|0.0001|TWO_SIDED|95.0|-1.6|-0.9||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 48||-0.9|-1.6|<0.0001
72627678|NCT00565409|144783946|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.29|||<|0.0001|TWO_SIDED|95.0|-1.6|-0.9||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 56||-0.9|-1.6|<0.0001
72627679|NCT00565409|144783946|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.13||||0.4645|TWO_SIDED|95.0|-0.5|0.2||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 56||0.2|-0.5|0.4645
72409869|NCT01969838|144328199|NON_INFERIORITY|To evaluate the noninferiority of MMB over RUX, a conventional 2-sided confidence interval (CI) was calculated for the difference in splenic response rate (SRR) at Week 24: delta = prob(MMB) - 0.6\*prob(RUX). If the lower bound of the 2-sided 95% CI for delta was greater than 0, MMB was declared noninferior to RUX in SRR at Week 24. The 2-sided 95% CI of delta was calculated based on stratum-adjusted Cochran-Mantel-Haenszel (CMH) proportions. This is the noninferiority proportion difference.|Proportion Difference - Stratified CMH|0.09||||0.014|TWO_SIDED|95.0|0.02|0.16|||Cochran-Mantel-Haenszel|||||0.16|0.02|0.014
72627680|NCT00565409|144783946|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.16|||<|0.0001|TWO_SIDED|95.0|-1.5|-0.8||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 56||-0.8|-1.5|<0.0001
72575616|NCT00468650|144677430|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.83|STANDARD_DEVIATION|1.49|<|0.001||95.0|0.55|1.11||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 LOCF minus Week 2||1.11|0.55|<0.001
72575617|NCT00468650|144677430|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.83|STANDARD_DEVIATION|1.49|<|0.001||95.0|0.55|1.11||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 Endpoint minus Week 2||1.11|0.55|<0.001
72627681|NCT00565409|144783946|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.3|||<|0.0001|TWO_SIDED|95.0|-1.7|-0.9||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 64||-0.9|-1.7|<0.0001
72627682|NCT00565409|144783946|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.16||||0.3793|TWO_SIDED|95.0|-0.5|0.2||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 64||0.2|-0.5|0.3793
72575618|NCT00468650|144677431|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|3.18|STANDARD_DEVIATION|2.42|<|0.001||95.0|2.73|3.63||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 2 minus Baseline||3.63|2.73|<0.001
72575619|NCT00468650|144677431|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|4.38|STANDARD_DEVIATION|2.39|<|0.001||95.0|3.94|4.83||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 4 minus Baseline||4.83|3.94|<0.001
72575620|NCT00468650|144677431|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|4.73|STANDARD_DEVIATION|2.53|<|0.001||95.0|4.25|5.21||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 minus Baseline||5.21|4.25|<0.001
72575621|NCT00468650|144677431|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|4.7|STANDARD_DEVIATION|2.52|<|0.001||95.0|4.23|5.17||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 LOCF minus Baseline||5.17|4.23|<0.001
72575622|NCT00468650|144677431|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|4.72|STANDARD_DEVIATION|2.52|<|0.001||95.0|4.25|5.19||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 Endpoint minus Baseline||5.19|4.25|<0.001
72575623|NCT00468650|144677432|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|1.2|STANDARD_DEVIATION|2.1|<|0.001||95.0|0.8|1.59||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 4 minus Week 2||1.59|0.80|<0.001
72575624|NCT00468650|144677432|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|1.54|STANDARD_DEVIATION|2.2|<|0.001||95.0|1.12|1.95||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 minus Week 2||1.95|1.12|<0.001
72575625|NCT00468650|144677432|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|1.54|STANDARD_DEVIATION|2.19|<|0.001||95.0|1.13|1.95||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 LOCF minus Week 2||1.95|1.13|<0.001
72409870|NCT01969838|144328200|NON_INFERIORITY|To evaluate the noninferiority of MMB over RUX, a conventional 2-sided CI was calculated for the difference in TSS response rate at Week 24: delta = prob(MMB) - 0.67\*prob(RUX). If the lower bound of the 2-sided 95% CI for delta was greater than 0, MMB was declared to be noninferior to RUX in TSS response rate at Week 24. The 2-sided 95% CI of delta was calculated based on stratum-adjusted Cochran-Mantel-Haenszel (CMH) proportions. This is called the noninferiority proportion difference.|Proportion Difference - Stratified CMH|0.0||||0.98|TWO_SIDED|95.0|-0.08|0.08|||Cochran-Mantel-Haenszel|||||0.08|-0.08|0.98
72409871|NCT01969838|144328201|SUPERIORITY||Rate ratio|0.28|||<|0.001|TWO_SIDED|95.0|0.19|0.43|||Negative Binomial Model, Adjusted||A smaller ratio represents larger benefit.|||0.43|0.19|<0.001
72575626|NCT00468650|144677432|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|1.54|STANDARD_DEVIATION|2.19|<|0.001||95.0|1.13|1.95||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 Endpoint minus Week 2||1.95|1.13|<0.001
72575627|NCT00468650|144677433|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|2.73|STANDARD_DEVIATION|2.38|<|0.001||95.0|2.28|3.17||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 2 minus Baseline||3.17|2.28|<0.001
72575628|NCT00468650|144677433|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|3.67|STANDARD_DEVIATION|2.49|<|0.001||95.0|3.2|4.14||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 4 minus Baseline||4.14|3.20|<0.001
72575629|NCT00468650|144677433|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|3.92|STANDARD_DEVIATION|2.52|<|0.001||95.0|3.44|4.4||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 minus Baseline||4.40|3.44|<0.001
72575630|NCT00468650|144677433|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|3.91|STANDARD_DEVIATION|2.53|<|0.001||95.0|3.44|4.38||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 LOCF minus Baseline||4.38|3.44|<0.001
72575631|NCT00468650|144677433|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|3.89|STANDARD_DEVIATION|2.53|<|0.001||95.0|3.42|4.37||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 Endpoint minus Baseline||4.37|3.42|<0.001
72575632|NCT00468650|144677434|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.97|STANDARD_DEVIATION|1.88|<|0.001||95.0|0.62|1.32||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 4 minus Week 2||1.32|0.62|<0.001
72575633|NCT00468650|144677434|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|1.21|STANDARD_DEVIATION|1.92|<|0.001||95.0|0.85|1.57||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 minus Week 2||1.57|0.85|<0.001
72575634|NCT00468650|144677434|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|1.2|STANDARD_DEVIATION|1.9|<|0.001||95.0|0.84|1.55||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 LOCF minus Week 2||1.55|0.84|<0.001
72575635|NCT00468650|144677434|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|1.2|STANDARD_DEVIATION|1.9|<|0.001||95.0|0.84|1.55||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 Endpoint minus Week 2||1.55|0.84|<0.001
72575636|NCT00468650|144677435|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|32.71|STANDARD_DEVIATION|25.36|<|0.001||95.0|27.98|37.43||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 2 minus Baseline||37.43|27.98|<0.001
72541022|NCT05180630|144611330|OTHER|||||||0.154||||||When p-value is adjusted for multiple comparisons, the level of statistical significance must be \</= to 0.01666667 (.05/3).|ANOVA|||Treatment order was not analyzed. A repeated measures ANOVA was performed to compare the effect of the coupling conditions on sound quality ratings for own voice, but there was no analysis between groups.||||0.154
72541023|NCT01029769|144611331|OTHER|"a logistic regression model with remission as the dependent variable and switch of treatment (yes/no) and PANSS-total score at visit 3 as independent variables was used. Multiple imputation (based upon 20 imputations, primary analysis), last observation carried forward and completers only analyses were performed."|||||=|0.01||||||Multiple imputation was performed separately for the switch and non-switch arms and the imputation model included the PANSS total score from all visits from phase II baseline (visit 2) onwards, remission at visit 7 and phase I arm allocation|Regression, Logistic|||Irrespective of the initially assigned antipsychotic treatment in period 1 of the trial (2-week-phase), the patients showing little improvement over the two weeks of treatment in period 1 now switched from the initial treatment in period 2 of the trial (6-week-phase) were grouped together as well as the patients non-switched from their initial treatment.||||=0.01
72541024|NCT00709735|144611334|SUPERIORITY||Mean Difference (Final Values)|-13.0|||||TWO_SIDED|95.0|-30.0|4.0|||||Non-Reactivation Propranolol (NRP) - Reactivation Propranolol (RP)|||4.0|-30.0|
72627683|NCT00565409|144783946|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.14|||<|0.0001|TWO_SIDED|95.0|-1.5|-0.8||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 64||-0.8|-1.5|<0.0001
72541025|NCT00709735|144611335|SUPERIORITY||Mean Difference (Final Values)|-12.7|||||TWO_SIDED|95.0|-27.4|1.9|||||Non-Reactivation Propranolol (NRP) - Reactivation Propranolol (RP)|||1.9|-27.4|
72541026|NCT00666718|144611336|NON_INFERIORITY_OR_EQUIVALENCE|"Assuming a drop-out rate after randomization of approximately 15%, the remaining 160 patients in each treatment group should allow confirmation of noninferiority with no true treatment difference and a noninferiority limit of 0.4% using the upper limit of a 2-sided 95% confidence interval (insulin lispro protamine suspension + insulin lispro minus insulin glargine+insulin lispro) at a significance level of 0.025 with 90% power."|Mean Difference (Final Values)|0.1|||||TWO_SIDED|95.0|-0.11|0.31|||ANCOVA|||||0.31|-0.11|
72541027|NCT00666718|144611337|SUPERIORITY_OR_OTHER|||||||0.458||95.0||||p-value is for Week 12 Change.|Mixed Models Analysis|Change from baseline=Treatment+country+baseline HbA1c+week+treatment\*country+treatment\*week+baseline HbA1c\*treatment (unstructured covariance used).||||||0.4580
72541028|NCT00666718|144611337|SUPERIORITY_OR_OTHER|||||||0.107||95.0||||p-value is for Week 24 Change.|Mixed Models Analysis|Change from baseline=Treatment+country+baseline HbA1c+week+treatment\*country+treatment\*week+baseline HbA1c\*treatment (unstructured covariance used).||||||0.1070
72575637|NCT00468650|144677435|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|46.21|STANDARD_DEVIATION|26.27|<|0.001||95.0|41.29|51.12||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 4 minus Baseline||51.12|41.29|<0.001
72575638|NCT00468650|144677435|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|45.53|STANDARD_DEVIATION|26.96|<|0.001||95.0|40.44|50.63||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 minus Baseline||50.63|40.44|<0.001
72627684|NCT00565409|144783946|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.6|||<|0.0001|TWO_SIDED|95.0|-2.0|-1.2||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 72||-1.2|-2.0|<0.0001
72627685|NCT00565409|144783946|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.34||||0.0816|TWO_SIDED|95.0|-0.7|0.0||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 72||0.0|-0.7|0.0816
72627686|NCT00565409|144783946|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.26|||<|0.0001|TWO_SIDED|95.0|-1.6|-0.9||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 72||-0.9|-1.6|<0.0001
72409872|NCT01969838|144328202|SUPERIORITY||Proportion Difference - Stratified CMH|0.18|||<|0.001|TWO_SIDED|95.0|0.09|0.26|||Cochran-Mantel-Haenszel||A larger proportion represents larger benefit.|||0.26|0.09|<0.001
72409873|NCT01969838|144328203|SUPERIORITY||Proportion Difference - Stratified CMH|-0.1||||0.019|TWO_SIDED|95.0|-0.19|-0.02|||Cochran-Mantel-Haenszel||A smaller proportion represents larger benefit.|||-0.02|-0.19|0.019
72409874|NCT01176591|144328211|SUPERIORITY_OR_OTHER_LEGACY|||||||0.08|||||||t-test, 2 sided|||||||0.08
72541029|NCT00666718|144611338|SUPERIORITY_OR_OTHER|||||||0.1333||95.0||||p-value is for HbA1c \<7.0%.|Fisher Exact|||||||0.1333
72541030|NCT00666718|144611338|SUPERIORITY_OR_OTHER|||||||0.1213||95.0||||p-value is for HbA1c \<=6.5%|Fisher Exact|||||||0.1213
72541031|NCT00666718|144611339|SUPERIORITY_OR_OTHER||LS Mean Difference|0.37|||||TWO_SIDED|95.0|-0.43|1.17|||Mixed Models Analysis|Morning Pre-Meal measurement = Treatment+country+week+treatment\*country + treatment\*week (unstructured covariance was used)||||1.17|-0.43|
72541032|NCT00666718|144611339|SUPERIORITY_OR_OTHER||LS Mean Difference|0.26|||||TWO_SIDED|95.0|-0.66|1.19|||Mixed Models Analysis|Morning Postprandial measurement = Treatment +country+week+treatment\*country + treatment\*week (unstructured covariance was used)||||1.19|-0.66|
72541033|NCT00666718|144611339|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.29|||||TWO_SIDED|95.0|-1.15|0.57|||Mixed Models Analysis|Midday Pre-Meal measurement = Treatment +country + week +treatment\*country + treatment\*week (unstructured covariance was used).||||0.57|-1.15|
72541034|NCT00666718|144611339|SUPERIORITY_OR_OTHER||LS Mean Difference|0.47|||||TWO_SIDED|95.0|-0.46|1.4|||Mixed Models Analysis|Midday Postprandial measurement = Treatment+country+week+treatment\*country + treatment\*week (unstructured covariance was used).||||1.40|-0.46|
72541035|NCT00666718|144611339|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.05|||||TWO_SIDED|95.0|-0.93|0.83|||Mixed Models Analysis|Evening Pre-Meal measurement = Treatment +country+week+treatment\*country + treatment\*week (unstructured covariance was used).||||0.83|-0.93|
72541036|NCT00666718|144611339|SUPERIORITY_OR_OTHER||LS Mean Difference|0.46|||||TWO_SIDED|95.0|-0.41|1.34|||Mixed Models Analysis|Evening Postprandial measurement = Treatment+country+week +treatment\*country + treatment\*week (unstructured covariance was used).||||1.34|-0.41|
72575639|NCT00468650|144677435|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|45.28|STANDARD_DEVIATION|27.01|<|0.001||95.0|40.25|50.31||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 LOCF minus Baseline||50.31|40.25|<0.001
72575640|NCT00468650|144677435|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|45.05|STANDARD_DEVIATION|27.02|<|0.001||95.0|39.99|50.11||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 Endpoint minus Baseline||50.11|39.99|<0.001
72575641|NCT00468650|144677436|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|13.84|STANDARD_DEVIATION|21.1|<|0.001||95.0|9.89|17.79||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 4 minus Week 2||17.79|9.89|<0.001
72575642|NCT00468650|144677436|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|13.07|STANDARD_DEVIATION|24.25|<|0.001||95.0|8.49|17.65||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 minus Week 2||17.65|8.49|<0.001
72575643|NCT00468650|144677436|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|12.69|STANDARD_DEVIATION|24.26|<|0.001||95.0|8.14|17.23||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 LOCF minus Week 2||17.23|8.14|<0.001
72575644|NCT00468650|144677436|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|12.69|STANDARD_DEVIATION|24.26|<|0.001||95.0|8.14|17.23||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 Endpoint minus Week 2||17.23|8.14|<0.001
72575645|NCT00468650|144677437|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|5.41|STANDARD_DEVIATION|4.4|<|0.001||95.0|4.59|6.23||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 2 minus Baseline||6.23|4.59|<0.001
72575646|NCT00468650|144677437|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|8.85|STANDARD_DEVIATION|4.96|<|0.001||95.0|7.92|9.78||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 4 minus Baseline||9.78|7.92|<0.001
72575647|NCT00468650|144677437|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|9.21|STANDARD_DEVIATION|5.19|<|0.001||95.0|8.23|10.19||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 minus Baseline||10.19|8.23|<0.001
72575648|NCT00468650|144677437|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|9.28|STANDARD_DEVIATION|5.14|<|0.001||95.0|8.32|10.24||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 LOCF minus Baseline||10.24|8.32|<0.001
72575649|NCT00468650|144677437|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|9.25|STANDARD_DEVIATION|5.15|<|0.001||95.0|8.28|10.22||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 Endpoint minus Baseline||10.22|8.28|<0.001
72575650|NCT00468650|144677438|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|3.51|STANDARD_DEVIATION|3.89|<|0.001||95.0|2.78|4.24||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 4 minus Week 2||4.24|2.78|<0.001
72575651|NCT00468650|144677438|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|3.91|STANDARD_DEVIATION|4.41|<|0.001||95.0|3.08|4.74||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 minus Week 2||4.74|3.08|<0.001
72575652|NCT00468650|144677438|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|3.91|STANDARD_DEVIATION|4.38|<|0.001||95.0|3.09|4.73||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 LOCF minus Week 2||4.73|3.09|<0.001
72575653|NCT00468650|144677438|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|3.91|STANDARD_DEVIATION|4.38|<|0.001||95.0|3.09|4.73||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 Endpoint minus Week 2||4.73|3.09|<0.001
72575654|NCT00468650|144677439|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|6.68|STANDARD_DEVIATION|4.86|<|0.001||95.0|5.77|7.59||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 2 minus Baseline||7.59|5.77|<0.001
72627687|NCT00565409|144783946|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.54|||<|0.0001|TWO_SIDED|95.0|-1.9|-1.2||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 80||-1.2|-1.9|<0.0001
72409875|NCT01176591|144328212|SUPERIORITY_OR_OTHER_LEGACY|||||||0.08|||||||t-test, 2 sided|||||||0.08
72575655|NCT00468650|144677439|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|9.94|STANDARD_DEVIATION|5.21|<|0.001||95.0|8.96|10.91||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 4 minus Baseline||10.91|8.96|<0.001
72575656|NCT00468650|144677439|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|10.59|STANDARD_DEVIATION|5.08|<|0.001||95.0|9.62|11.56||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 minus Baseline||11.56|9.62|<0.001
72575657|NCT00468650|144677439|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|10.63|STANDARD_DEVIATION|5.03|<|0.001||95.0|9.68|11.58||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 LOCF minus Baseline||11.58|9.68|<0.001
72575658|NCT00468650|144677439|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|10.64|STANDARD_DEVIATION|5.06|<|0.001||95.0|9.68|11.59||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 Endpoint minus Baseline||11.59|9.68|<0.001
72627688|NCT00565409|144783946|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.42||||0.0256|TWO_SIDED|95.0|-0.8|-0.1||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 80||-0.1|-0.8|0.0256
72409876|NCT01176591|144328213|SUPERIORITY_OR_OTHER_LEGACY|||||||0.046|||||||t-test, 2 sided|||||||0.046
72409877|NCT01176591|144328214|SUPERIORITY_OR_OTHER_LEGACY|||||||0.039|||||||t-test, 2 sided|||||||0.039
72541037|NCT00666718|144611339|SUPERIORITY_OR_OTHER||LS Mean Difference|0.14|||||TWO_SIDED|95.0|-0.67|0.96|||Mixed Models Analysis|0300 Hours measurement = Treatment+country+week+treatment\*country+treatment\*week (unstructured covariance was used).||||0.96|-0.67|
72541038|NCT00666718|144611340|SUPERIORITY_OR_OTHER|||||||0.5568||95.0||||p-value is for Fasting.|ANCOVA|Glycemic variability = Treatment+country grouping (Mediterranean, rest of Europe)+treatment\*country (Mediterranean, rest of Europe)||||||0.5568
72541039|NCT00666718|144611340|SUPERIORITY_OR_OTHER|||||||0.7523||95.0||||p-value is for Post-breakfast.|ANCOVA|Glycemic variability = Treatment+country grouping (Mediterranean, rest of Europe)+treatment\*country (Mediterranean, rest of Europe)||||||0.7523
72541040|NCT00666718|144611340|SUPERIORITY_OR_OTHER|||||||0.6448||95.0||||p-value is for Post-lunch.|ANCOVA|Glycemic variability = Treatment+country grouping (Mediterranean, rest of Europe)+treatment\*country (Mediterranean, rest of Europe)||||||0.6448
72627689|NCT00565409|144783946|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.13|||<|0.0001|TWO_SIDED|95.0|-1.5|-0.8||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 80||-0.8|-1.5|<0.0001
72627690|NCT00565409|144783946|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.54|||<|0.0001|TWO_SIDED|95.0|-1.9|-1.2||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 88||-1.2|-1.9|<0.0001
72627691|NCT00565409|144783946|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3||||0.1158|TWO_SIDED|95.0|-0.7|0.1||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 88||0.1|-0.7|0.1158
72627692|NCT00565409|144783946|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.24|||<|0.0001|TWO_SIDED|95.0|-1.6|-0.9||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 88||-0.9|-1.6|<0.0001
72627693|NCT00565409|144783949|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-41.67||||0.0214|TWO_SIDED|95.0|-77.1|-6.2||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 40||-6.2|-77.1|0.0214
72627694|NCT00565409|144783949|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.57||||0.5544|TWO_SIDED|95.0|-45.6|24.5||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 40||24.5|-45.6|0.5544
72627695|NCT00565409|144783949|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-31.1||||0.0826|TWO_SIDED|95.0|-66.2|4.0||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 40||4.0|-66.2|0.0826
72627696|NCT00565409|144783949|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-80.05||||0.0001|TWO_SIDED|95.0|-120.3|-39.8||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 48||-39.8|-120.3|0.0001
72627697|NCT00565409|144783949|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-43.18||||0.0344|TWO_SIDED|95.0|-83.2|-3.2||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 48||-3.2|-83.2|0.0344
72627698|NCT00565409|144783949|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-36.87||||0.0721|TWO_SIDED|95.0|-77.1|3.3||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 48||3.3|-77.1|0.0721
72409878|NCT01176591|144328216|SUPERIORITY_OR_OTHER_LEGACY|||||||0.035|||||||t-test, 2 sided|||||||0.035
72409879|NCT00408993|144328217|SUPERIORITY_OR_OTHER|||||||0.617||95.0||||Treatment effects were evaluated based on a two-sided significance level of 0.05 and interaction effects at 0.10. No adjustments for multiple comparisons were made.|ANCOVA|Model=Treatment, Pooled Investigator and Baseline.||With 104 patients per arm, the study has at least 85% power to detect a treatment group difference of -1.20 points in baseline to endpoint mean change on the BPI 24-hour average pain score between Duloxetine and Placebo. Sample size determined using a two-sided t-test with alpha=0.05, and assuming a common standard deviation of 2.5 and a discontinuation rate of 25%.||||0.617
72541041|NCT00666718|144611340|SUPERIORITY_OR_OTHER|||||||0.9122||95.0||||p-value is for Post-dinner.|ANCOVA|Glycemic variability = Treatment+country grouping (Mediterranean, rest of Europe)+ treatment\*country (Mediterranean, rest of Europe)||||||0.9122
72541042|NCT00666718|144611341|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.53|||||TWO_SIDED|95.0|-1.19|0.12|||Mixed Models Analysis|Hypoglycemia rate per 30 days = Treatment+Country+Week+Treatment\*Country+Treatment\*Week (unstructured covariance structure was used)||||0.12|-1.19|
72541043|NCT00666718|144611341|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.04|||||TWO_SIDED|95.0|-0.2|0.11|||Mixed Models Analysis|Hypoglycemia rate per 30 days = Treatment+Country+Week+Treatment\*Country+Treatment\*Week (unstructured covariance structure was used)||||0.11|-0.20|
72541044|NCT00666718|144611341|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.45|||||TWO_SIDED|95.0|-1.06|0.16|||Mixed Models Analysis|Hypoglycemia rate per 30 days = Treatment+Country+Week+Treatment\*Country+Treatment\*Week (unstructured covariance structure was used)||||0.16|-1.06|
72541045|NCT00666718|144611341|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4|||||TWO_SIDED|95.0|-0.86|0.06|||Mixed Models Analysis|Hypoglycemia rate per 30 days = Treatment+Country+Week+Treatment\*Country+Treatment\*Week (unstructured covariance structure was used)||||0.06|-0.86|
72541046|NCT00666718|144611341|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.01|||||TWO_SIDED|95.0|-0.14|0.12|||Mixed Models Analysis|Hypoglycemia rate per 30 days=Treatment+Country+Week+Treatment\*Country+Treatment\*Week (unstructured covariance structure was used)||||0.12|-0.14|
72541047|NCT00666718|144611342|SUPERIORITY_OR_OTHER|||||||0.1701||95.0||||p-value is for \>=1 hypoglycemic episode.|Fisher Exact|||||||0.1701
72541048|NCT00666718|144611342|SUPERIORITY_OR_OTHER|||||||0.1727||95.0||||p-value is for \>=1 nocturnal hypoglycemic episode.|Fisher Exact|||||||0.1727
72541049|NCT00666718|144611342|SUPERIORITY_OR_OTHER|||||||0.2094||95.0||||p-value is for \>=1 non-nocturnal hypoglycemic episode.|Fisher Exact|||||||0.2094
72541050|NCT00666718|144611342|SUPERIORITY_OR_OTHER|||||||0.623||95.0||||p-value is for \>=1 severe hypoglycemic episode.|Fisher Exact|||||||0.6230
72541051|NCT00666718|144611344|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.16|||||TWO_SIDED|95.0|-0.86|0.55|||ANCOVA|weight change from baseline = Treatment + country + baseline Hb1Ac + baseline weight + treatment\*HbA1c baseline value||||0.55|-0.86|
72541052|NCT00666718|144611345|SUPERIORITY_OR_OTHER||LS Mean Difference|2.18|||||TWO_SIDED|95.0|-8.33|12.68|||Mixed Models Analysis|Total daily insulin dose=Treatment+country+week+treatment\*country+ treatment\*week (unstructured covariance was used).||||12.68|-8.33|
72541053|NCT03496207|144611347|SUPERIORITY||Difference in Least Squares Means|-151.1|STANDARD_ERROR_OF_MEAN|49.53||0.003|TWO_SIDED|95.0|-249.59|-52.63|||ANCOVA|ANCOVA was used to compare change from baseline values with randomization stratification factor (WHO functional class) and baseline PVR as covariate.||Analysis based on calculated LS means.||-52.63|-249.59|0.0030
72541054|NCT03496207|144611347|SUPERIORITY||Difference in Least Squares Means|-269.4|STANDARD_ERROR_OF_MEAN|48.48|<|0.0001|TWO_SIDED|95.0|-365.81|-173.03|||ANCOVA|ANCOVA was used to compare change from baseline values with randomization stratification factor (WHO functional class) and baseline PVR as covariate.||Analysis based on calculated LS means.||-173.03|-365.81|<.0001
72541055|NCT03496207|144611348|SUPERIORITY||Difference in Least Squares Means|-13.9|STANDARD_ERROR_OF_MEAN|50.95||0.7851|TWO_SIDED|95.0|-113.85|86.06|||ANCOVA|ANCOVA was used to compare change from baseline values with randomization stratification factor (WHO functional class) and baseline PVR as covariate.||Analysis based on calculated LS means.||86.06|-113.85|0.7851
72541056|NCT03496207|144611349|SUPERIORITY||Multiple Imputation Mean Difference|-223.2|STANDARD_ERROR_OF_MEAN|57.45|<|0.0001|TWO_SIDED|95.0|-335.83|-110.49||Comparison of baseline and final value|ANCOVA||Standard multiple imputations are done with imputed values that are within the range of the minimum and maximum observed values using linear regression including baseline measurements.|||-110.49|-335.83|<.0001
72541057|NCT00810615|144611386|SUPERIORITY_OR_OTHER|||||||0.05|||||||ANCOVA|A repeated measures model was designed so as to incorporate the adjust for the repeated (dependent) measures within individuals over time.||ANCOVA, baseline measurement was considered as a covariate and group (sham or 2.4 ATA), treatment (15 treatments, 30 treatments, and 6 weeks) as well as the interaction between group and treatment were considered as the independent variables.||||0.05
72369251|NCT00611026|144248561|SUPERIORITY_OR_OTHER|||||||0.0219|TWO_SIDED|||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with terms for country and treatment and ranked baseline value as a covariate.||Treatment difference Tolterodine ER vs Fesoterodine at Week 4.||||0.0219
72541058|NCT00810615|144611398|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.5455||||||||||||||Relative Risk of Improvement in 2.4 ATA group vs. Sham in subjects with one significant event (blast or impact resulting in concussion symptoms) per Concussion History. PCL-M with significant improvement defined as a score decrease 10 or more.||||
72541059|NCT00810615|144611399|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.1||||||||||||||Relative Risk of Improvement in 2.4 ATA group vs. Sham in subjects with two significant events (blast or impact resulting in concussion symptoms) per Concussion History. PCL-M with significant improvement defined as a score decrease 10 or more.||||
72541060|NCT00810615|144611400|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.1111||||||||||||||Relative Risk of Improvement in 2.4 ATA group vs. Sham in subjects with three significant events (blast or impact resulting in concussion symptoms) per Concussion History. PCL-M with significant improvement defined as a score decrease 10 or more.||||
72541061|NCT00810615|144611401|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.0||||||||||||||Relative Risk of Improvement in 2.4 ATA group vs. Sham in subjects with four or more significant events (blast or impact resulting in concussion symptoms) per Concussion History. PCL-M with significant improvement defined as a score decrease 10 or more.||||
72541062|NCT02567266|144611408|SUPERIORITY||Mean Difference (Net)|-0.19|STANDARD_ERROR_OF_MEAN|0.2||0.338|TWO_SIDED|95.0|-0.58|0.2||Threshold: p \< .05|Mixed Models Analysis||A negative value for the mean difference indicates that the lower numbered Group has a lower mean than the higher numbered group.|DV = CGI-I at Post-Treatment||.20|-.58|.338
72541063|NCT02567266|144611408|SUPERIORITY||Mean Difference (Net)|0.16|STANDARD_ERROR_OF_MEAN|0.2||0.425|TWO_SIDED|95.0|-0.24|0.57||Threshold: p \<.05|Mixed Models Analysis||A negative value for the mean difference indicates that the lower numbered Group has a lower mean than the higher numbered group.|DV = CGI-I at Post Treatment||0.57|-0.24|0.425
72541064|NCT02567266|144611408|SUPERIORITY||Mean Difference (Net)|-0.36|STANDARD_ERROR_OF_MEAN|0.21||0.09|TWO_SIDED|95.0|-0.77|0.06||Threshold: p \< .05|Mixed Models Analysis||A negative value for the mean difference indicates that the lower numbered Group has a lower mean than the higher numbered group.|DV = CGI-I at Post||0.06|-0.77|0.09
72541065|NCT02567266|144611408|SUPERIORITY||Mean Difference (Net)|-0.32|STANDARD_ERROR_OF_MEAN|0.2||0.126|TWO_SIDED|95.0|-0.72|0.09||Threshold: p \< .05|Mixed Models Analysis||A negative value for the mean difference indicates that the lower numbered Group has a lower mean than the higher numbered group.|DV = CGI-I at Follow-Up||0.09|-0.72|0.126
72541066|NCT02567266|144611408|SUPERIORITY||Mean Difference (Net)|-0.23|STANDARD_ERROR_OF_MEAN|0.21||0.28|TWO_SIDED|95.0|-0.65|0.19||Threshold: p \< .05|Mixed Models Analysis||A negative value for the mean difference indicates that the lower numbered Group has a lower mean than the higher numbered group.|DV = CGI-I at Follow-Up||0.19|-0.65|0.28
72541067|NCT02567266|144611408|SUPERIORITY||Mean Difference (Net)|-0.08|STANDARD_ERROR_OF_MEAN|0.21||0.697|TWO_SIDED|95.0|-0.51|0.34||Threshold: p \< .05|Mixed Models Analysis||A negative value for the mean difference indicates that the lower numbered Group has a lower mean than the higher numbered group.|DV = CGI-I at Follow-Up||0.34|-0.51|0.697
72541068|NCT02567266|144611409|SUPERIORITY||Mean Difference (Net)|-0.08|STANDARD_ERROR_OF_MEAN|0.26||0.779|TWO_SIDED|95.0|-0.6|0.45||Threshold: p \< .05|Mixed Models Analysis||A negative value for the mean difference indicates that the lower numbered Group has a lower mean than the higher numbered group.|DV = CGI-S at Follow-Up||0.45|-0.6|0.779
72541069|NCT02567266|144611409|SUPERIORITY||Mean Difference (Net)|0.12|STANDARD_ERROR_OF_MEAN|0.27||0.66|TWO_SIDED|95.0|-0.42|0.67||Threshold: p \< .05|Mixed Models Analysis||A negative value for the mean difference indicates that the lower numbered Group has a lower mean than the higher numbered group.|DV = CGI-S at Follow-Up||0.67|-0.42|0.66
72541070|NCT02567266|144611409|SUPERIORITY||Mean Difference (Net)|-0.1|STANDARD_ERROR_OF_MEAN|0.21||0.629|TWO_SIDED|95.0|-0.51|0.31||Threshold: p \< .05|Mixed Models Analysis||A negative value for the mean difference indicates that the lower numbered Group has a lower mean than the higher numbered group.|DV = CGI-S at Post||0.31|-0.51|0.629
72541071|NCT02567266|144611409|SUPERIORITY||Mean Difference (Net)|-0.02|STANDARD_ERROR_OF_MEAN|0.2||0.938|TWO_SIDED|95.0|-0.41|0.38||Threshold: p \< .05|Mixed Models Analysis||A negative value for the mean difference indicates that the lower numbered Group has a lower mean than the higher numbered group.|DV = CGI-S at Post||0.38|-0.41|0.938
72541072|NCT02567266|144611409|SUPERIORITY||Mean Difference (Net)|0.09|STANDARD_ERROR_OF_MEAN|0.21||0.68|TWO_SIDED|95.0|-0.32|0.49||Threshold: p \< .05|Mixed Models Analysis||A negative value for the mean difference indicates that the lower numbered Group has a lower mean than the higher numbered group.|DV = CGI-S at Post||0.49|-0.32|0.68
72541073|NCT02567266|144611409|SUPERIORITY||Mean Difference (Net)|-0.2|STANDARD_ERROR_OF_MEAN|0.28||0.479|TWO_SIDED|95.0|-0.75|0.35||Threshold: p \< .05|Mixed Models Analysis||A negative value for the mean difference indicates that the lower numbered Group has a lower mean than the higher numbered group.|DV = CGI-S at Follow-Up||0.35|-0.75|0.479
72541074|NCT02567266|144611410|SUPERIORITY||Mean Difference (Net)|0.3|STANDARD_ERROR_OF_MEAN|1.58||0.852|TWO_SIDED|95.0|-2.85|3.45||Threshold: p \< .05|Mixed Models Analysis||A negative value for the mean difference indicates that the lower numbered Group has a lower mean than the higher numbered group.|DV = CGAS at Post||3.45|-2.85|0.852
72541075|NCT02567266|144611410|SUPERIORITY||Mean Difference (Net)|-0.17|STANDARD_ERROR_OF_MEAN|1.62||0.917|TWO_SIDED|95.0|-3.41|3.07||Threshold: p \< .05|Mixed Models Analysis||A negative value for the mean difference indicates that the lower numbered Group has a lower mean than the higher numbered group.|DV = CGAS at Post||3.07|-3.41|0.917
72541076|NCT02567266|144611410|SUPERIORITY||Mean Difference (Net)|0.47|STANDARD_ERROR_OF_MEAN|1.66||0.778|TWO_SIDED|95.0|-2.81|3.74||Threshold: p \< .05|Mixed Models Analysis||A negative value for the mean difference indicates that the lower numbered Group has a lower mean than the higher numbered group.|DV = CGAS at Post||3.74|-2.81|0.778
72541077|NCT02567266|144611410|SUPERIORITY||Mean Difference (Net)|0.95|STANDARD_ERROR_OF_MEAN|2.12||0.66|TWO_SIDED|95.0|-3.3|5.19||Threshold: p \< .05|Mixed Models Analysis||A negative value for the mean difference indicates that the lower numbered Group has a lower mean than the higher numbered group.|DV = CGAS at Follow-Up||5.19|-3.3|0.66
72541078|NCT02567266|144611410|SUPERIORITY||Mean Difference (Net)|-0.18|STANDARD_ERROR_OF_MEAN|2.19||0.935|TWO_SIDED|95.0|-4.55|4.19||Threshold: p \< .05|Mixed Models Analysis||A negative value for the mean difference indicates that the lower numbered Group has a lower mean than the higher numbered group.|DV = CGAS at Follow-Up||4.19|-4.55|0.935
72541079|NCT02567266|144611410|SUPERIORITY||Mean Difference (Net)|1.13|STANDARD_ERROR_OF_MEAN|2.21||0.615|TWO_SIDED|95.0|-3.29|5.55||Threshold: p \< .05|Mixed Models Analysis||A negative value for the mean difference indicates that the lower numbered Group has a lower mean than the higher numbered group.|DV = CGAS at Follow-Up||5.55|-3.29|0.615
72541080|NCT02164539|144611411|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.103||||0.024|TWO_SIDED|95.0|0.014|0.193|||Final step dose response model|||||0.193|0.014|0.024
72541081|NCT02164539|144611411|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.103||||0.024|TWO_SIDED|95.0|0.014|0.193|||Final step dose response model|||||0.193|0.014|0.024
72541082|NCT02164539|144611411|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.103||||0.024|TWO_SIDED|95.0|0.014|0.193|||Final step dose response model|||||0.193|0.014|0.024
72541083|NCT02164539|144611411|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.103||||0.024|TWO_SIDED|95.0|0.014|0.193|||Final step dose response model|||||0.193|0.014|0.024
72541084|NCT02164539|144611411|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.073||||0.152|TWO_SIDED|95.0|-0.027|0.172|||Final dose response model|||||0.172|-0.027|0.152
72541085|NCT02164539|144611412|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.0||||0.01|TWO_SIDED|95.0|-1.7|-0.2|||ANCOVA|||||-0.2|-1.7|0.010
72541086|NCT02164539|144611412|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.1||||0.004|TWO_SIDED|95.0|-1.9|-0.4|||ANCOVA||Statistical analysis presented for daily rescue medication use.|||-0.4|-1.9|0.004
72541087|NCT02164539|144611412|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.7||||0.083|TWO_SIDED|95.0|-1.4|0.1|||ANCOVA||Statistical analysis presented for daily rescue medication use.|||0.1|-1.4|0.083
72541088|NCT02164539|144611412|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.8||||0.014|TWO_SIDED|95.0|-1.5|-0.2|||ANCOVA||Statistical analysis presented for daily rescue medication use.|||-0.2|-1.5|0.014
72541089|NCT02164539|144611412|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.7||||0.031|TWO_SIDED|95.0|-1.4|-0.1|||ANCOVA||Statistical analysis presented for daily rescue medication use.|||-0.1|-1.4|0.031
72409880|NCT00408993|144328218|SUPERIORITY_OR_OTHER|||||||0.07||95.0||||P-value for Worst Pain Score|ANCOVA|Model=Treatment, Pooled Investigator, Baseline and Major Depressive Disorder status at baseline.||||||0.070
72541090|NCT02164539|144611413|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.1|||<|0.001|TWO_SIDED|95.0|-4.6|-1.7|||ANCOVA|||||-1.7|-4.6|<0.001
72541091|NCT02164539|144611413|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.0|||<|0.001|TWO_SIDED|95.0|-4.5|-1.6|||ANCOVA|||||-1.6|-4.5|<0.001
72541092|NCT02164539|144611413|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.0||||0.007|TWO_SIDED|95.0|-3.4|-0.6|||ANCOVA|||||-0.6|-3.4|0.007
72575659|NCT00468650|144677440|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|3.29|STANDARD_DEVIATION|4.1|<|0.001||95.0|2.52|4.05||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 4 minus Week 2||4.05|2.52|<0.001
72575660|NCT00468650|144677440|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|4.03|STANDARD_DEVIATION|5.09|<|0.001||95.0|3.06|5.0||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 minus Week 2||5.00|3.06|<0.001
72575661|NCT00468650|144677440|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|4.01|STANDARD_DEVIATION|5.04|<|0.001||95.0|3.06|4.96||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 LOCF minus Week 2||4.96|3.06|<0.001
72575662|NCT00468650|144677440|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|4.01|STANDARD_DEVIATION|5.04|<|0.001||95.0|3.06|4.96||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 Endpoint minus Week 2||4.96|3.06|<0.001
72575663|NCT00468650|144677441|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|2.79|STANDARD_DEVIATION|2.44|<|0.001||95.0|2.33|3.24||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 2 minus Baseline||3.24|2.33|<0.001
72575664|NCT00468650|144677441|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|4.23|STANDARD_DEVIATION|2.56|<|0.001||95.0|3.74|4.71||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 4 minus Baseline||4.71|3.74|<0.001
72575665|NCT00468650|144677441|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|4.74|STANDARD_DEVIATION|2.84|<|0.001||95.0|4.2|5.28||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 minus Baseline||5.28|4.20|<0.001
72627699|NCT00565409|144783949|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-89.19|||<|0.0001|TWO_SIDED|95.0|-128.7|-49.7||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 56||-49.7|-128.7|<0.0001
72409881|NCT00408993|144328218|SUPERIORITY_OR_OTHER|||||||0.151||95.0||||P-value for Least Pain Score|ANCOVA|Model=Treatment, Pooled Investigator, Baseline and Major Depressive Disorder status at baseline.||||||0.151
72409882|NCT00408993|144328218|SUPERIORITY_OR_OTHER|||||||0.012||95.0||||P-value for Pain Right Now Score|ANCOVA|Model=Treatment, Pooled Investigator, Baseline and Major Depressive Disorder status at baseline.||||||0.012
72541093|NCT02164539|144611413|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.0||||0.002|TWO_SIDED|95.0|-3.2|-0.7|||ANCOVA|||||-0.7|-3.2|0.002
72541094|NCT02164539|144611413|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.7||||0.009|TWO_SIDED|95.0|-2.9|-0.4|||ANCOVA|||||-0.4|-2.9|0.009
72541095|NCT02164539|144611414|SUPERIORITY_OR_OTHER||Mean Difference (Net)|18.1||||0.004||95.0|5.9|30.3|||ANCOVA|||||30.3|5.9|0.004
72541096|NCT02164539|144611414|SUPERIORITY_OR_OTHER||Mean Difference (Net)|21.8|||<|0.001|TWO_SIDED|95.0|9.4|34.1|||ANCOVA|||||34.1|9.4|<0.001
72541097|NCT02164539|144611414|SUPERIORITY_OR_OTHER||Mean Difference (Net)|19.7||||0.001|TWO_SIDED|95.0|7.7|31.7|||ANCOVA|||||31.7|7.7|0.001
72541098|NCT02164539|144611414|SUPERIORITY_OR_OTHER||Mean Difference (Net)|24.8|||<|0.001|TWO_SIDED|95.0|14.1|35.4|||ANCOVA|||||35.4|14.1|<0.001
72541099|NCT02164539|144611414|SUPERIORITY_OR_OTHER||Mean Difference (Net)|18.5|||<|0.001|TWO_SIDED|95.0|8.0|29.1|||ANCOVA|||||29.1|8.0|<0.001
72541100|NCT02164539|144611415|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.045||||0.264|TWO_SIDED|95.0|-0.034|0.125|||ANCOVA|||||0.125|-0.034|0.264
72575666|NCT00468650|144677441|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|4.78|STANDARD_DEVIATION|2.81|<|0.001||95.0|4.25|5.31||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 LOCF minus Baseline||5.31|4.25|<0.001
72575667|NCT00468650|144677441|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|4.76|STANDARD_DEVIATION|2.82|<|0.001||95.0|4.23|5.3||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 Endpoint minus Baseline||5.30|4.23|<0.001
72575668|NCT00468650|144677442|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|1.49|STANDARD_DEVIATION|1.91|<|0.001||95.0|1.13|1.85||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 4 minus Week 2||1.85|1.13|<0.001
72575669|NCT00468650|144677442|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|1.96|STANDARD_DEVIATION|2.08|<|0.001||95.0|1.57|2.36||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 minus Week 2||2.36|1.57|<0.001
72575670|NCT00468650|144677442|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|1.98|STANDARD_DEVIATION|2.07|<|0.001||95.0|1.59|2.37||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 LOCF minus Week 2||2.37|1.59|<0.001
72627700|NCT00565409|144783949|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-26.14||||0.191|TWO_SIDED|95.0|-65.4|13.1||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 56||13.1|-65.4|0.1910
72627701|NCT00565409|144783949|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-63.05||||0.0018|TWO_SIDED|95.0|-102.5|-23.6||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 56||-23.6|-102.5|0.0018
72627702|NCT00565409|144783949|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-84.36||||0.0002|TWO_SIDED|95.0|-129.1|-39.6||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 64||-39.6|-129.1|0.0002
72627703|NCT00565409|144783949|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.85||||0.935|TWO_SIDED|95.0|-46.3|42.6||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 64||42.6|-46.3|0.9350
72627704|NCT00565409|144783949|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-82.52||||0.0003|TWO_SIDED|95.0|-127.2|-37.8||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 64||-37.8|-127.2|0.0003
72627705|NCT00565409|144783949|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-108.73|||<|0.0001|TWO_SIDED|95.0|-157.0|-60.4||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 72||-60.4|-157.0|<0.0001
72627706|NCT00565409|144783949|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.2||||0.6764|TWO_SIDED|95.0|-58.2|37.8||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 72||37.8|-58.2|0.6764
72627707|NCT00565409|144783949|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-98.53|||<|0.0001|TWO_SIDED|95.0|-146.7|-50.3||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 72||-50.3|-146.7|<0.0001
72627708|NCT00565409|144783949|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-115.48|||<|0.0001|TWO_SIDED|95.0|-157.7|-73.3||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 80||-73.3|-157.7|<0.0001
72627709|NCT00565409|144783949|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.69||||0.5219|TWO_SIDED|95.0|-55.6|28.3||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 80||28.3|-55.6|0.5219
72627710|NCT00565409|144783949|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-101.8|||<|0.0001|TWO_SIDED|95.0|-144.0|-59.6||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 80||-59.6|-144.0|<0.0001
72409883|NCT00408993|144328218|SUPERIORITY_OR_OTHER|||||||0.077||95.0||||P-value for Average Interference Score|ANCOVA|Model=Treatment, Pooled Investigator, Baseline and Major Depressive Disorder status at baseline.||||||0.077
72409884|NCT00408993|144328219|SUPERIORITY_OR_OTHER|||||||0.036||95.0|||||ANCOVA|Model=Treatment, Pooled Investigator, Baseline and Major Depressive Disorder status at baseline.||||||0.036
72409885|NCT00408993|144328220|SUPERIORITY_OR_OTHER|||||||0.955||95.0||||P-value for Visit 3|Mixed Models Analysis|Repeated Measures: Model=Treatment, Pooled Investigator, Visit, Baseline, baseline MDD status, Treatment\*Visit and Baseline\*Visit.||||||0.955
72541101|NCT02164539|144611415|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.04||||0.328|TWO_SIDED|95.0|-0.041|0.121|||ANCOVA|||||0.121|-0.041|0.328
72541102|NCT02164539|144611415|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.025||||0.534|TWO_SIDED|95.0|-0.054|0.103|||ANCOVA|||||0.103|-0.054|0.534
72541103|NCT02164539|144611415|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.005||||0.895|TWO_SIDED|95.0|-0.065|0.075|||ANCOVA|||||0.075|-0.065|0.895
72627711|NCT00565409|144783949|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-71.6||||0.002|TWO_SIDED|95.0|-116.9|-26.3||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 88||-26.3|-116.9|0.0020
72627712|NCT00565409|144783949|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.3||||0.5917|TWO_SIDED|95.0|-32.7|57.3||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 88||57.3|-32.7|0.5917
72627713|NCT00565409|144783949|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-83.91||||0.0003|TWO_SIDED|95.0|-129.2|-38.7||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 88||-38.7|-129.2|0.0003
72627714|NCT00565409|144783952|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.79|||<|0.0001|TWO_SIDED|95.0|-11.9|-5.7||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 40||-5.7|-11.9|<0.0001
72627715|NCT00565409|144783952|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.55||||0.1033|TWO_SIDED|95.0|-5.6|0.5||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 40||0.5|-5.6|0.1033
72627716|NCT00565409|144783952|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.23|||<|0.0001|TWO_SIDED|95.0|-9.3|-3.1||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 40||-3.1|-9.3|<0.0001
72627717|NCT00565409|144783952|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.09|||<|0.0001|TWO_SIDED|95.0|-15.4|-8.8||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 48||-8.8|-15.4|<0.0001
72627718|NCT00565409|144783952|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.69||||0.6802|TWO_SIDED|95.0|-4.0|2.6||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 48||2.6|-4.0|0.6802
72575671|NCT00468650|144677442|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|1.98|STANDARD_DEVIATION|2.07|<|0.001||95.0|1.59|2.37||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 Endpoint minus Week 2||2.37|1.59|<0.001
72575672|NCT00468650|144677443|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Net)|8.84|STANDARD_DEVIATION|28.7||0.0016||95.0|3.42|14.26||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 2 minus baseline||14.26|3.42|0.0016
72575673|NCT00468650|144677443|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|10.18|STANDARD_DEVIATION|27.51|<|0.001||95.0|4.93|15.43||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 4 minus baseline||15.43|4.93|<0.001
72575674|NCT00468650|144677443|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|12.29|STANDARD_DEVIATION|28.88|<|0.001||95.0|6.7|17.88||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 minus baseline||17.88|6.70|<0.001
72575675|NCT00468650|144677443|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|11.96|STANDARD_DEVIATION|28.33|<|0.001||95.0|6.61|17.32||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 LOCF minus baseline||17.32|6.61|<0.001
72575676|NCT00468650|144677443|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|11.95|STANDARD_DEVIATION|28.55|<|0.001||95.0|6.51|17.4||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 Endpoint minus baseline||17.40|6.51|<0.001
72575677|NCT00468650|144677444|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|1.37|STANDARD_DEVIATION|14.85||0.3324||95.0|-1.42|4.17||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 4 minus Week 2||4.17|-1.42|0.3324
72575678|NCT00468650|144677444|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|3.12|STANDARD_DEVIATION|14.26||0.0249||95.0|0.4|5.84||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 minus Week 2||5.84|0.40|0.0249
72575679|NCT00468650|144677444|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|2.98|STANDARD_DEVIATION|13.95||0.0249||95.0|0.37|5.58||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 LOCF minus Week 2||5.58|0.37|0.0249
72627719|NCT00565409|144783952|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.39|||<|0.0001|TWO_SIDED|95.0|-14.7|-8.1||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 48||-8.1|-14.7|<0.0001
72627720|NCT00565409|144783952|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.09|||<|0.0001|TWO_SIDED|95.0|-15.6|-8.6||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 56||-8.6|-15.6|<0.0001
72575680|NCT00468650|144677444|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|3.04|STANDARD_DEVIATION|14.07||0.0249||95.0|0.39|5.68||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 Endpoint minus Week 2||5.68|0.39|0.0249
72575681|NCT00468650|144677445|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|15.37|STANDARD_DEVIATION|30.51|<|0.001||95.0|9.38|21.36||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 2 minus baseline||21.36|9.38|<0.001
72575682|NCT00468650|144677445|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|17.15|STANDARD_DEVIATION|32.22|<|0.001||95.0|10.76|23.55||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 4 minus baseline||23.55|10.76|<0.001
72575683|NCT00468650|144677445|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|18.22|STANDARD_DEVIATION|32.44|<|0.001||95.0|11.68|24.76||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 minus baseline||24.76|11.68|<0.001
72575684|NCT00468650|144677445|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|17.33|STANDARD_DEVIATION|31.87|<|0.001||95.0|11.07|23.59||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 LOCF minus baseline||23.59|11.07|<0.001
72575685|NCT00468650|144677445|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|17.68|STANDARD_DEVIATION|32.1|<|0.001||95.0|11.31|24.04||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 Endpoint minus baseline||24.04|11.31|<0.001
72575686|NCT00468650|144677446|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|1.46|STANDARD_DEVIATION|9.41||0.1061||95.0|-0.32|3.24||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 4 minus Week 2||3.24|-0.32|0.1061
72575687|NCT00468650|144677446|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|1.18|STANDARD_DEVIATION|12.33||0.3237||95.0|-1.18|3.54||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 minus Week 2||3.54|-1.18|0.3237
72575688|NCT00468650|144677446|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|1.13|STANDARD_DEVIATION|12.05||0.3236||95.0|-1.13|3.38||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 LOCF minus Week 2||3.38|-1.13|0.3236
72627721|NCT00565409|144783952|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.36||||0.4404|TWO_SIDED|95.0|-4.8|2.1||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 56||2.1|-4.8|0.4404
72627722|NCT00565409|144783952|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.73|||<|0.0001|TWO_SIDED|95.0|-14.2|-7.2||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 56||-7.2|-14.2|<0.0001
72409886|NCT00408993|144328220|SUPERIORITY_OR_OTHER|||||||0.004||95.0||||P-value for Visit 4|Mixed Models Analysis|Repeated Measures: Model=Treatment, Pooled Investigator, Visit, Baseline, baseline MDD status, Treatment\*Visit and Baseline\*Visit.||||||0.004
72409887|NCT00408993|144328220|SUPERIORITY_OR_OTHER|||||||0.037||95.0||||P-value for Visit 5|Mixed Models Analysis|Repeated Measures: Model=Treatment, Pooled Investigator, Visit, Baseline, baseline MDD status, Treatment\*Visit and Baseline\*Visit.||||||0.037
72409888|NCT00408993|144328220|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Visit 6|Mixed Models Analysis|Repeated Measures: Model=Treatment, Pooled Investigator, Visit, Baseline, baseline MDD status, Treatment\*Visit and Baseline\*Visit.||||||<0.001
72575689|NCT00468650|144677446|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|1.15|STANDARD_DEVIATION|12.16||0.3236||95.0|-1.15|3.45||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 Endpoint minus Week 2||3.45|-1.15|0.3236
72409889|NCT00408993|144328220|SUPERIORITY_OR_OTHER|||||||0.028||95.0||||P-value for Visit 7|Mixed Models Analysis|Repeated Measures: Model=Treatment, Pooled Investigator, Visit, Baseline, baseline MDD status, Treatment\*Visit and Baseline\*Visit.||||||0.028
72409890|NCT00408993|144328221|SUPERIORITY_OR_OTHER|||||||0.207||95.0|||||ANCOVA|Model=Treatment, Pooled Investigator, Baseline and Major Depressive Disorder status at baseline.||||||0.207
72409891|NCT00408993|144328222|SUPERIORITY_OR_OTHER|||||||0.008||95.0|||||Fisher Exact|||||||0.008
72409892|NCT00408993|144328224|SUPERIORITY_OR_OTHER|||||||0.364||95.0||||P-value for 5-Item Score|ANCOVA|Model=Treatment, Pooled Investigator, Baseline and Major Depressive Disorder status at baseline.||||||0.364
72409893|NCT00408993|144328224|SUPERIORITY_OR_OTHER|||||||0.59||95.0||||P-value for 8-Item Score|ANCOVA|Model=Treatment, Pooled Investigator, Baseline and Major Depressive Disorder status at baseline.||||||0.590
72409894|NCT00408993|144328225|SUPERIORITY_OR_OTHER|||||||0.62||95.0|||||ANOVA|Model=Treatment and Pooled Investigator||||||0.620
72409895|NCT00408993|144328226|SUPERIORITY_OR_OTHER|||||||0.324||95.0|||||ANOVA|Model=Treatment and Pooled Investigator||||||0.324
72409896|NCT00408993|144328227|SUPERIORITY_OR_OTHER|||||||0.642||95.0||||P-value for Systolic Blood Pressure|ANOVA|Model=Treatment and Pooled Investigator||||||0.642
72409897|NCT00408993|144328227|SUPERIORITY_OR_OTHER|||||||0.601||95.0||||P-value for Diastolic Blood Pressure|ANOVA|Model=Treatment and Pooled Investigator||||||0.601
72409898|NCT00408993|144328228|SUPERIORITY_OR_OTHER|||||||0.014||95.0||||P-value for Chloride|ANOVA|Sums of squares from ANOVA on the ranks: Model=Treatment and Pooled Investigator for treatment effects p-value.||||||0.014
72409899|NCT00408993|144328228|SUPERIORITY_OR_OTHER|||||||0.005||95.0||||P-value for High Density Lipoprotein Cholesterol|ANOVA|Sums of squares from ANOVA on the ranks: Model=Treatment and Pooled Investigator for treatment effects p-value.||||||0.005
72409900|NCT00408993|144328228|SUPERIORITY_OR_OTHER|||||||0.011||95.0||||P-value for Sodium|ANOVA|Sums of squares from ANOVA on the ranks: Model=Treatment and Pooled Investigator for treatment effects p-value.||||||0.011
72541104|NCT02164539|144611415|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.076||||0.031|TWO_SIDED|95.0|0.007|0.146|||ANCOVA|||||0.146|0.007|0.031
72541105|NCT02164539|144611416|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.088||||0.019|TWO_SIDED|95.0|-0.162|-0.014|||ANCOVA|||||-0.014|-0.162|0.019
72541106|NCT02164539|144611416|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.091||||0.017|TWO_SIDED|95.0|-0.165|-0.016|||ANCOVA|||||-0.016|-0.165|0.017
72541107|NCT02164539|144611416|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.089||||0.017|TWO_SIDED|95.0|-0.162|-0.016|||ANCOVA|||||-0.016|-0.162|0.017
72541108|NCT02164539|144611416|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.06||||0.066|TWO_SIDED|95.0|-0.124|0.004|||ANCOVA|||||0.004|-0.124|0.066
72541109|NCT02164539|144611416|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.163|||<|0.001|TWO_SIDED|95.0|-0.227|-0.099|||ANCOVA|||||-0.099|-0.227|<0.001
72541110|NCT01255722|144611417|NON_INFERIORITY_OR_EQUIVALENCE|The clinical non-inferiority margin was set to -10% maximum difference with the best comparator (i.e. iopromide).|Mean Difference (Final Values)|-0.033||||0.05|TWO_SIDED|95.0|-0.088|0.021|||Chi-squared|||Iobitridol was compared to the best of the two comparators. The two-sided 95% confidence interval (CI) of the difference between both proportions (Iobitridol - Comparator) was computed and the lower limit of the CI compared to the clinical non-inferiority limit in the study. The non-inferiority of iobitridol over the best comparator was established if the lower limit of the two-sided 95% CI was equal to or higher than the clinical non-inferiority limit.||0.021|-0.088|0.05
72541111|NCT01255722|144611418|SUPERIORITY_OR_OTHER|||||||0.75|TWO_SIDED||||||Fisher Exact|||||||0.750
72541112|NCT01255722|144611420|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED||||||Fisher Exact|||||||0.001
72541113|NCT01255722|144611421|SUPERIORITY_OR_OTHER|||||||0.109|TWO_SIDED||||||Fisher Exact|||||||0.109
72541114|NCT01255722|144611422|SUPERIORITY_OR_OTHER|||||||0.09|TWO_SIDED||||||Fisher Exact|||||||0.09
72541115|NCT02643966|144611423|OTHER|We compared DBT cancer yield per 1,000 for first observer (usual care) vs DBT and WBUS cancer yield per 1,000 for first observer for Year/Screen 1.|simple proportions|1.3||||0.005|TWO_SIDED|95.0|0.3|2.1||The threshold for statistical significance was p = 0.05|nonparametric bootstrap approach|The 95% CIs for differences were estimated using nonparametric bootstrap approach on the basis of 10,000 replicates with women as resampling units||The primary unit of analysis was the screening examination. A sample size of 16,700 screens (6,200 women, estimating 8%-10% loss to follow-up each year) was expected to provide 82% power to identify an added cancer detection rate (CDR) from US of 1.1/1,000. Screens were included for analysis if the patient was diagnosed with breast cancer or at least 10.5-month imaging or clinical follow-up (ie, at end of study participation) showed no evidence of breast cancer.||2.1|0.3|0.005
72541116|NCT02643966|144611423|OTHER|We compared DBT cancer yield per 1,000 for first observer (usual care) vs DBT and WBUS cancer yield per 1,000 for first observer for Years/Screens 2 \& 3.|simple proportions|1.0|||<|0.001|TWO_SIDED|95.0|0.4|1.5||The threshold for statistical significance was p = 0.05|nonparametric bootstrap approach|The 95% CIs for differences were estimated using nonparametric bootstrap approach on the basis of 10,000 replicates with women as resampling units||The primary unit of analysis was the screening examination. A sample size of 16,700 screens (6,200 women, estimating 8%-10% loss to follow-up each year) was expected to provide 82% power to identify an added cancer detection rate (CDR) from US of 1.1/1,000. Screens were included for analysis if the patient was diagnosed with breast cancer or at least 10.5-month imaging or clinical follow-up (ie, at end of study participation) showed no evidence of breast cancer.||1.5|0.4|<0.001
72541117|NCT02643966|144611424|OTHER|We compared DBT true positive findings for first observer (usual care) vs DBT and WBUS true positive findings for first observer for Year/Screen 1.|simple proportions|17.8||||0.005|TWO_SIDED|95.0|4.4|31.1||The threshold for statistical significance was p = 0.05|nonparametric bootstrap approach|The 95% CIs for differences were estimated using nonparametric bootstrap approach on the basis of 10,000 replicates with women as resampling units||The primary unit of analysis was the screening examination. A sample size of 16,700 screens (6,200 women, estimating 8%-10% loss to follow-up each year) was expected to provide 82% power to identify an added cancer detection rate (CDR) from US of 1.1/1,000. Screens were included for analysis if the patient was diagnosed with breast cancer or at least 10.5-month imaging or clinical follow-up (ie, at end of study participation) showed no evidence of breast cancer.||31.1|4.4|0.005
72541118|NCT02643966|144611424|OTHER|We compared DBT true positive findings for first observer (usual care) vs DBT and WBUS true positive findings for first observer for Years/Screens 2 and 3.|simple proportions|13.5|||<|0.001|TWO_SIDED|95.0|4.9|22.3||The threshold for statistical significance was p = 0.05|nonparametric bootstrap approach|The 95% CIs for differences were estimated using nonparametric bootstrap approach on the basis of 10,000 replicates with women as resampling units||The primary unit of analysis was the screening examination. A sample size of 16,700 screens (6,200 women, estimating 8%-10% loss to follow-up each year) was expected to provide 82% power to identify an added CDR from US of 1.1/1,000.Screens were included for analysis if the patient was diagnosed with breast cancer or at least 10.5-month imaging or clinical follow-up (ie, at end of study participation) showed no evidence of breast cancer.||22.3|4.9|< 0.001
72541119|NCT02643966|144611426|OTHER|We compared DBT false positive findings for first observer (usual care) vs DBT and WBUS false positive findings for first observer for Year/Screen 1.|Slope|4.5|||<|0.001|TWO_SIDED|95.0|3.8|5.1||The threshold for statistical significance was p = 0.05|nonparametric bootstrap approach|The 95% CIs for differences were estimated using nonparametric bootstrap approach on the basis of 10,000 replicates with women as resampling units||||5.1|3.8|< 0.001
72541120|NCT02643966|144611426|OTHER|We compared DBT false positive findings for first observer (usual care) vs DBT and WBUS false positive findings for first observer for Years/Screens 2 \& 3.|simple proportions|3.7|||<|0.001|TWO_SIDED|95.0|3.3|4.1||The threshold for statistical significance was p = 0.05|nonparametric bootstrap approach|The 95% CIs for differences were estimated using nonparametric bootstrap approach on the basis of 10,000 replicates with women as resampling units||||4.1|3.3|< 0.001
72541121|NCT00446134|144611500|NON_INFERIORITY_OR_EQUIVALENCE|The study will have 70% to detect non-inferiority of taribavirin versus ribavirin using a non-inferiority margin of 12%.|Other|12.75|STANDARD_DEVIATION|5.0||0.167|TWO_SIDED|95.0|-3.65|29.15|||Fisher Exact|||||29.15|-3.65|0.167
72541122|NCT00446134|144611500|NON_INFERIORITY_OR_EQUIVALENCE|The study will have 70% to detect non-inferiority of taribavirin versus ribavirin using a non-inferiority margin of 12%.|Difference of Proportion|5.71|STANDARD_DEVIATION|5.0||0.611|TWO_SIDED|95.0|-10.76|22.19|||Fisher Exact|||||22.19|-10.76|0.611
72541123|NCT00446134|144611500|NON_INFERIORITY_OR_EQUIVALENCE|The study will have 70% to detect non-inferiority of taribavirin versus ribavirin using a non-inferiority margin of 12%.|Difference of Proportion|2.98|STANDARD_DEVIATION|5.0||0.736|TWO_SIDED|95.0|-13.67|19.63|||Fisher Exact|||||19.63|-13.67|0.736
72541124|NCT00446134|144611500|NON_INFERIORITY_OR_EQUIVALENCE|The study will have 70% to detect non-inferiority of taribavirin versus taribavirin using a non-inferiority margin of 12%.|Difference of Proportion|7.04|STANDARD_DEVIATION|5.0||0.485|TWO_SIDED|95.0|-9.28|23.35|||Fisher Exact|||||23.35|-9.28|0.485
72541125|NCT00446134|144611500|NON_INFERIORITY_OR_EQUIVALENCE|The study will have 70% to detect non-inferiority of taribavirin versus taribavirin using a non-inferiority margin of 12%.|Difference of Proportion|9.77|STANDARD_DEVIATION|5.0||0.295|TWO_SIDED|95.0|-6.72|26.26|||Fisher Exact|||||26.26|-6.72|0.295
72541126|NCT00446134|144611500|NON_INFERIORITY_OR_EQUIVALENCE|The study will have 70% to detect non-inferiority of taribavirin versus taribavirin using a non-inferiority margin of 12%.|Difference of Proportion|2.73|STANDARD_DEVIATION|5.0||0.864|TWO_SIDED|95.0|-13.84|19.3|||Fisher Exact|||||19.3|-13.84|0.864
72541127|NCT00446134|144611501|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.4|STANDARD_DEVIATION|5.0||0.0304|TWO_SIDED|95.0|2.31|30.57|||Chi-squared|||||30.57|2.31|0.0304
72541128|NCT00446134|144611501|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|17.1|STANDARD_DEVIATION|5.0||0.0293|TWO_SIDED|95.0|3.22|31.06|||Chi-squared|||||31.06|3.22|0.0293
72541129|NCT00446134|144611501|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.9|STANDARD_DEVIATION|5.0||0.5816|TWO_SIDED|95.0|-10.41|20.24|||Chi-squared|||||20.24|-10.41|0.5816
72541130|NCT00446134|144611502|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.22|STANDARD_DEVIATION|5.0||0.9999|TWO_SIDED|95.0|-13.78|16.22|||Fisher Exact|||||16.22|-13.78|0.9999
72541131|NCT00446134|144611502|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_DEVIATION|5.0||0.9999|TWO_SIDED|95.0|-14.73|14.73|||Fisher Exact|||||14.73|-14.73|0.9999
72541132|NCT00446134|144611502|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.8|STANDARD_DEVIATION|5.0||0.9999|TWO_SIDED|95.0|-14.11|15.71|||Fisher Exact|||||15.71|-14.11|0.9999
72541133|NCT00446134|144611502|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.22|STANDARD_DEVIATION|5.0||0.9999|TWO_SIDED|95.0|-13.78|16.22|||Fisher Exact|||||16.22|-13.78|0.9999
72575690|NCT00468650|144677447|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|56.96|STANDARD_DEVIATION|38.93|<|0.001||95.0|49.31|64.6||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 2 minus baseline||64.60|49.31|<0.001
72575691|NCT00468650|144677447|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|70.78|STANDARD_DEVIATION|35.46|<|0.001||95.0|63.74|77.81||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 4 minus baseline||77.81|63.74|<0.001
72541134|NCT00446134|144611502|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.42|STANDARD_DEVIATION|5.0||0.9999|TWO_SIDED|95.0|-14.76|15.59|||Fisher Exact|||||15.59|-14.76|0.9999
72541135|NCT00446134|144611502|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8|STANDARD_DEVIATION|5.0||0.9999|TWO_SIDED|95.0|-15.71|14.11|||Fisher Exact|||||14.11|-15.71|0.9999
72575692|NCT00468650|144677447|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|71.23|STANDARD_DEVIATION|35.79|<|0.001||95.0|64.02|78.45||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 minus baseline||78.45|64.02|<0.001
72541136|NCT02176642|144611520|NON_INFERIORITY|We estimated that women in the placebo group would have mean reduction of 3 UUI episodes per day. Assuming 50% improvement in UUI episodes per day is a clinically significant improvement, we estimated the experimental group would have a mean reduction of 4.5 UUI episodes per day with a SD of 1.5 UUI episodes per day. To detect such a difference with 80% power and alpha 0.05, we would need 88 participants for our analysis. To allow for a 12% dropout rate, our goal was to enroll 100 women.||||||0.2|||||||Wilcoxon (Mann-Whitney)|||||||0.2
72541137|NCT02176642|144611521|SUPERIORITY|||||||0.4|||||||Wilcoxon (Mann-Whitney)|||||||0.4
72541138|NCT02176642|144611522|SUPERIORITY|||||||0.48|||||||Wilcoxon (Mann-Whitney)|||||||0.48
72541139|NCT02176642|144611523|SUPERIORITY|||||||0.26|||||||Wilcoxon (Mann-Whitney)|||||||0.26
72541140|NCT02176642|144611524|SUPERIORITY|||||||0.06|||||||Wilcoxon (Mann-Whitney)|||||||0.06
72541141|NCT02176642|144611525|SUPERIORITY|||||||0.05|||||||Wilcoxon (Mann-Whitney)|||||||0.05
72541142|NCT02176642|144611526|SUPERIORITY|||||||0.44|||||||Wilcoxon (Mann-Whitney)|||||||0.44
72541143|NCT02176642|144611527|SUPERIORITY|||||||0.73|||||||Wilcoxon (Mann-Whitney)|||||||0.73
72541144|NCT02176642|144611528|SUPERIORITY|||||||0.94|||||||Wilcoxon (Mann-Whitney)|||||||0.94
72541145|NCT00295620|144611533|SUPERIORITY||Hazard Ratio (HR)|0.93||||0.425|TWO_SIDED|95.0|0.79|1.11|||Log Rank|||Arm A: Anastrozole for 2 yerars Arm B: Anastrozole for 5 years Null hypothesis: there is no difference between the two treatment arms in the probability of a DFS event||1.11|0.79|0.425
72541146|NCT00295620|144611534|SUPERIORITY||Hazard Ratio (HR)|1.02||||0.867|TWO_SIDED|95.0|0.83|1.25|||Log Rank|||Arm A: Anastrozole for 2 yerars Arm B: Anastrozole for 5 years Null hypothesis: there is no difference between the two treatment arms in the probability of a death event||1.25|0.83|0.867
72541147|NCT00295620|144611535|SUPERIORITY||Hazard Ratio (HR)|1.35||||0.052|TWO_SIDED|95.0|1.0|1.84|||Log Rank|||Arm A: Anastrozole for 2 yerars Arm B: Anastrozole for 5 years Null hypothesis: there is no difference between the two treatment arms in the probability of a fracture||1.84|1.00|0.052
72541148|NCT00295620|144611536|SUPERIORITY||Hazard Ratio (HR)|1.06||||0.678|TWO_SIDED|95.0|0.81|1.38|||Log Rank|||Arm A: Anastrozole for 2 yerars Arm B: Anastrozole for 5 years Null hypothesis: there is no difference between the two treatment arms in the probability of the occurrence of secondary carcinoma||1.38|0.81|0.678
72541149|NCT00295620|144611537|SUPERIORITY||Hazard Ratio (HR)|1.15||||0.531|TWO_SIDED|95.0|0.75|1.77|||Log Rank|||Arm A: Anastrozole for 2 years Arm B: Anastrozole for 5 years Null hypothesis: there is no difference between the two treatment arms in the probability of the occurrence of contralateral mammacarcinoma||1.77|0.75|0.531
72541150|NCT02989610|144611539|SUPERIORITY|Superiority hypothesis was that 95% lower confidence bound on proportion exceeded a threshold of 60%.|||||<|0.0001|||||||Clopper-Pearson method|||Proportion with wider therapeutic window using directional stimulation was compared to a performance goal of 60%.||||<0.0001
72541151|NCT02989610|144611540|NON_INFERIORITY|Non-inferiority hypothesis was that 95% lower confidence bound on proportion exceeded a threshold of 40%.|||||<|0.0001|||||||Clopper-Pearson method|||Proportion with wider therapeutic window using directional stimulation was compared to a performance goal of 60%.||||<0.0001
72541152|NCT02989610|144611541|SUPERIORITY|||||||1|||||||t-test, 1 sided|Paired t-test.||"Comparison of UPDRS part III on medication from 3 months using omnidirectional stimulation to 6 months using directional stimulation.~The p-value presented is calculated and does not represent the threshold. The statistical test used for this endpoint is single sided, and the observed difference was in the opposite direction of the tested difference, leading to a p-value that is equivalent to 1 within the significance of the statistical software used."||||1.0000
72575693|NCT00468650|144677447|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|72.15|STANDARD_DEVIATION|35.41|<|0.001||95.0|65.2|79.11||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 LOCF minus baseline||79.11|65.20|<0.001
72541153|NCT04179474|144611542|EQUIVALENCE|"No effect of co-administration with erenumab on the PK of ubrogepant was concluded if the 90% CIs for the geometric mean ratios of ubrogepant PK parameters for test study intervention (ubrogepant in combination with erenumab) versus reference study intervention (ubrogepant alone) were within the limits of 80% to 125%."|Ratio of Geometric Mean Percentage|105.55|||||TWO_SIDED|90.0|96.21|115.79|||||Ratio of Geometric Mean Percentage=Ubrogepant in Combination with Erenumab/Ubrogepant Alone \* 100|A linear mixed-effects model with study intervention as fixed effect and participant as a random effect was used to determine the Geometric Means.||115.79|96.21|
72541154|NCT04179474|144611543|EQUIVALENCE|"No effect of co-administration with galcanezumab on the PK of ubrogepant was concluded if the 90% CIs for the geometric mean ratios of ubrogepant PK parameters for test study intervention (ubrogepant in combination with galcanezumab) versus reference study intervention (ubrogepant alone) were within the limits of 80% to 125%."|Ratio of Geometric Mean Percentage|105.03|||||TWO_SIDED|90.0|89.55|123.19|||||Ratio of Geometric Mean Percentage=Ubrogepant in Combination with Galcanezumab/Ubrogepant Alone \* 100|A linear mixed-effects model with study intervention as fixed effect and participant as a random effect was used to determine the Geometric Means.||123.19|89.55|
72541155|NCT04179474|144611544|EQUIVALENCE|"No effect of co-administration with erenumab on the PK of ubrogepant was concluded if the 90% CIs for the geometric mean ratios of ubrogepant PK parameters for test study intervention (ubrogepant in combination with erenumab) versus reference study intervention (ubrogepant alone) were within the limits of 80% to 125%."|Ratio of Geometric Mean Percentage|105.38|||||TWO_SIDED|90.0|96.19|115.45|||||Ratio of Geometric Mean Percentage=Ubrogepant in Combination with Erenumab/Ubrogepant Alone \* 100|A linear mixed-effects model with study intervention as fixed effect and participant as a random effect was used to determine the Geometric Means.||115.45|96.19|
72541156|NCT04179474|144611545|EQUIVALENCE|"No effect of co-administration with galcanezumab on the PK of ubrogepant was concluded if the 90% CIs for the geometric mean ratios of ubrogepant PK parameters for test study intervention (ubrogepant in combination with galcanezumab) versus reference study intervention (ubrogepant alone) were within the limits of 80% to 125%."|Ratio of Geometric Mean Percentage|104.76|||||TWO_SIDED|90.0|89.68|122.38|||||Ratio of Geometric Mean Percentage=Ubrogepant in Combination with Galcanezumab/Ubrogepant Alone \* 100|A linear mixed-effects model with study intervention as fixed effect and participant as a random effect was used to determine the Geometric Means.||122.38|89.68|
72541157|NCT04179474|144611546|EQUIVALENCE|"No effect of co-administration with erenumab on the PK of ubrogepant was concluded if the 90% CIs for the geometric mean ratios of ubrogepant PK parameters for test study intervention (ubrogepant in combination with erenumab) versus reference study intervention (ubrogepant alone) were within the limits of 80% to 125%."|Ratio of Geometric Mean Percentage|103.86|||||TWO_SIDED|90.0|93.01|115.98|||||Ratio of Geometric Mean Percentage=Ubrogepant in Combination with Erenumab/Ubrogepant Alone \* 100|A linear mixed-effects model with study intervention as fixed effect and participant as a random effect was used to determine the Geometric Means||115.98|93.01|
72541158|NCT04179474|144611547|EQUIVALENCE|"No effect of co-administration with galcanezumab on the PK of ubrogepant was concluded if the 90% CIs for the geometric mean ratios of ubrogepant PK parameters for test study intervention (ubrogepant in combination with galcanezumab) versus reference study intervention (ubrogepant alone) were within the limits of 80% to 125%."|Ratio of Geometric Mean Percentage|99.55|||||TWO_SIDED|90.0|82.27|120.45|||||Ratio of Geometric Mean Percentage=Ubrogepant in Combination with Galcanezumab/Ubrogepant Alone \* 100|A linear mixed-effects model with study intervention as fixed effect and participant as a random effect was used to determine the Geometric Means.||120.45|82.27|
72541159|NCT02556632|144611564|OTHER|||||||0.9306|||||||ANOVA|||||||0.9306
72541160|NCT02556632|144611565|OTHER|||||||0.8048|||||||Fisher Exact|||||||0.8048
72541161|NCT02556632|144611566|OTHER|||||||0.8591|||||||ANOVA|||||||0.8591
72575694|NCT00468650|144677447|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|71.6|STANDARD_DEVIATION|35.55|<|0.001||95.0|64.54|78.65||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 Endpoint minus baseline||78.65|64.54|<0.001
72575695|NCT00468650|144677448|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|13.56|STANDARD_DEVIATION|30.89|<|0.001||95.0|7.72|19.4||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 4 minus Week 2||19.40|7.72|<0.001
72575696|NCT00468650|144677448|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|14.25|STANDARD_DEVIATION|31.31|<|0.001||95.0|8.25|20.25||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 minus Week 2||20.25|8.25|<0.001
72575697|NCT00468650|144677448|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|14.51|STANDARD_DEVIATION|31.77|<|0.001||95.0|8.56|20.46||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 LOCF minus Week 2||20.46|8.56|<0.001
72575698|NCT00468650|144677448|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|14.77|STANDARD_DEVIATION|32.0|<|0.001||95.0|8.72|20.82||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 Endpoint minus Week 2||20.82|8.72|<0.001
72575699|NCT00468650|144677449|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|58.58|STANDARD_DEVIATION|41.24|<|0.001||95.0|50.48|66.68||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 2 minus baseline||66.68|50.48|<0.001
72575700|NCT00468650|144677449|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|76.29|STANDARD_DEVIATION|37.21|<|0.001||95.0|68.9|83.67||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 4 minus baseline||83.67|68.90|<0.001
72575701|NCT00468650|144677449|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|77.69|STANDARD_DEVIATION|37.26|<|0.001||95.0|70.18|85.21||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 minus baseline||85.21|70.18|<0.001
72575702|NCT00468650|144677449|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|78.79|STANDARD_DEVIATION|36.65|<|0.001||95.0|71.59|85.99||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 LOCF minus baseline||85.99|71.59|<0.001
72575703|NCT00468650|144677449|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|78.36|STANDARD_DEVIATION|36.89|<|0.001||95.0|71.04|85.68||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 Endpoint minus baseline||85.68|71.04|<0.001
72575704|NCT00468650|144677450|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|17.9|STANDARD_DEVIATION|36.63|<|0.001||95.0|10.98|24.83||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 4 minus Week 2||24.83|10.98|<0.001
72575705|NCT00468650|144677450|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|19.5|STANDARD_DEVIATION|36.84|<|0.001||95.0|12.44|26.56||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 minus Week 2||26.56|12.44|<0.001
72575706|NCT00468650|144677450|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|19.52|STANDARD_DEVIATION|36.99|<|0.001||95.0|12.59|26.45||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 LOCF minus Week 2||26.45|12.59|<0.001
72575707|NCT00468650|144677450|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|19.88|STANDARD_DEVIATION|37.23|<|0.001||95.0|12.84|26.91||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 Endpoint minus Week 2||26.91|12.84|<0.001
72575708|NCT00468650|144677451|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|57.34|STANDARD_DEVIATION|42.6|<|0.001||95.0|48.93|65.75||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 2 minus baseline||65.75|48.93|<0.001
72575709|NCT00468650|144677451|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|70.72|STANDARD_DEVIATION|40.3|<|0.001||95.0|62.72|78.71||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 4 minus baseline||78.71|62.72|<0.001
72575710|NCT00468650|144677451|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|70.63|STANDARD_DEVIATION|40.78|<|0.001||95.0|62.41|78.85||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 minus baseline||78.85|62.41|<0.001
72575711|NCT00468650|144677451|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|72.07|STANDARD_DEVIATION|40.27|<|0.001||95.0|64.16|79.98||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 LOCF minus baseline||79.98|64.16|<0.001
72541162|NCT01083901|144611582|SUPERIORITY_OR_OTHER|||||||0.38|||||||ANCOVA|Changes from baseline to 16 weeks were regressed on the baseline measurement.||The null hypothesis was that the changes in total body fat-free mass in response to resistance exercise training would not be different among the groups. The expected difference in fat-free mass between the Acetaminophen and Placebo groups was 1.8 +/- 1.0% with a 3.6 +/1 1.0% increase in fat-free mass in the Placebo group. The study was designed to achieve 96% power at the 0.05 level with 10 men in the acetaminophen and placebo groups.||||0.38
72541163|NCT01083901|144611583|SUPERIORITY_OR_OTHER|||||||0.23|||||||ANCOVA|The change in fat mass was regressed on the baseline measure.||||||0.23
72575712|NCT00468650|144677451|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|71.51|STANDARD_DEVIATION|40.48|<|0.001||95.0|63.48|79.55||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 Endpoint minus baseline||79.55|63.48|<0.001
72575713|NCT00468650|144677452|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|13.1|STANDARD_DEVIATION|29.11|<|0.001||95.0|7.58|18.63||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 4 minus Week 2||18.63|7.58|<0.001
72575714|NCT00468650|144677452|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|14.11|STANDARD_DEVIATION|32.53|<|0.001||95.0|7.84|20.37||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 minus Week 2||20.37|7.84|<0.001
72575715|NCT00468650|144677452|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|13.47|STANDARD_DEVIATION|31.92|<|0.001||95.0|7.47|19.47||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 LOCF minus Week 2||19.47|7.47|<0.001
72575716|NCT00468650|144677452|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|13.72|STANDARD_DEVIATION|32.16|<|0.001||95.0|7.61|19.82||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 Endpoint minus Week 2||19.82|7.61|<0.001
72575717|NCT00468650|144677453|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|56.96|STANDARD_DEVIATION|38.93|<|0.001||95.0|49.31|64.6||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 2 minus Baseline||64.60|49.31|<0.001
72575718|NCT00468650|144677453|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|70.78|STANDARD_DEVIATION|35.46|<|0.001||95.0|63.74|77.81||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 4 minus baseline||77.81|63.74|<0.001
72575719|NCT00468650|144677453|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|71.23|STANDARD_DEVIATION|35.79|<|0.001||95.0|64.02|78.45||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 minus baseline||78.45|64.02|<0.001
72575720|NCT00468650|144677453|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|72.15|STANDARD_DEVIATION|35.41|<|0.001||95.0|65.2|79.11||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 LOCF minus baseline||79.11|65.20|<0.001
72575721|NCT00468650|144677453|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|71.6|STANDARD_DEVIATION|35.55|<|0.001||95.0|64.54|78.65||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 Endpoint minus baseline||78.65|64.54|<0.001
72575722|NCT00468650|144677454|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|13.56|STANDARD_DEVIATION|30.89|<|0.001||95.0|7.72|19.4||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 4 minus Week 2||19.40|7.72|<0.001
72575723|NCT00468650|144677454|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|14.25|STANDARD_DEVIATION|31.31|<|0.001||95.0|8.25|20.25||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 minus Week 2||20.25|8.25|<0.001
72575724|NCT00468650|144677454|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|14.51|STANDARD_DEVIATION|31.77|<|0.001||95.0|8.56|20.46||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 LOCF minus Week 2||20.46|8.56|<0.001
72575725|NCT00468650|144677454|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|14.77|STANDARD_DEVIATION|32.0|<|0.001||95.0|8.72|20.82||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 Endpoint minus Week 2||20.82|8.72|<0.001
72409901|NCT00408993|144328228|SUPERIORITY_OR_OTHER|||||||0.044||95.0||||P-value for triglycerides|ANOVA|Sums of squares from ANOVA on the ranks: Model=Treatment and Pooled Investigator for treatment effects p-value.||||||0.044
72575726|NCT00468650|144677455|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-12.58|STANDARD_DEVIATION|37.77||0.001||95.0|-19.96|-5.2||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 2 minus baseline||-5.20|-19.96|0.0010
72575727|NCT00468650|144677455|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-20.55|STANDARD_DEVIATION|35.04|<|0.001||95.0|-27.47|-13.64||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 4 minus baseline||-13.64|-27.47|<0.001
72575728|NCT00468650|144677455|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-22.53|STANDARD_DEVIATION|36.64|<|0.001||95.0|-29.88|-15.18||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 minus baseline||-15.18|-29.88|<0.001
72409902|NCT00408993|144328229|SUPERIORITY_OR_OTHER|||||||0.017||95.0|||||ANOVA|Sums of squares from ANOVA on the ranks: Model=Treatment and Pooled Investigator for treatment effects p-values.||||||0.017
72541164|NCT01083901|144611584|SUPERIORITY_OR_OTHER|||||||0.3|||||||ANCOVA|Change in strength was regressed on baseline measures.||||||0.30
72541165|NCT01083901|144611585|SUPERIORITY_OR_OTHER|||||||0.37|||||||ANCOVA|Changes in strength were regressed on the baseline measure.||||||0.37
72541166|NCT04508621|144611590|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.16||0.115|TWO_SIDED|95.0|-0.6|0.1|||Mixed Model Repeated Measures|Multiple imputation used for missing data.|Treatment difference = TNX-102 SL - Placebo|||0.1|-0.6|0.115
72541167|NCT04508621|144611591|SUPERIORITY|Patients with missing data considered non-responders.|Difference in Proportions|8.0||||0.038|TWO_SIDED|95.0|0.5|15.5|||Pearson Chi-Squared|||||15.5|0.5|0.038
72541168|NCT04508621|144611592|SUPERIORITY||LS Mean Difference|-3.4|STANDARD_ERROR_OF_MEAN|1.55||0.03|TWO_SIDED|95.0|-6.4|-0.3|||Mixed Model Repeated Measures|Multiple imputation used for missing data.|Treatment difference = TNX-102 SL - Placebo|||-0.3|-6.4|0.030
72541169|NCT04508621|144611593|SUPERIORITY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|1.46||0.797|TWO_SIDED|95.0|-3.2|2.5|||Mixed Model Repeated Measures|Multiple imputation used for missing data.|Treatment Difference = TNX-102 SL - Placebo|||2.5|-3.2|0.797
72541170|NCT04508621|144611594|SUPERIORITY||LS Mean Difference|-2.3|STANDARD_ERROR_OF_MEAN|0.8||0.004|TWO_SIDED|95.0|-3.8|-0.7|||Mixed Model Repeated Measures|Multiple imputation used for missing data.|Treatment Difference = TNX-102 SL - Placebo|||-0.7|-3.8|0.004
72541171|NCT04508621|144611595|SUPERIORITY||LS Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|0.74||0.101|TWO_SIDED|95.0|-2.7|0.2|||Mixed Model Repeated Measures|Multiple imputation used for missing data.|Treatment Difference = TNX-102 SL - Placebo|||0.2|-2.7|0.101
72541172|NCT04508621|144611596|SUPERIORITY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.16||0.094|TWO_SIDED|95.0|-0.6|0.0|||Mixed Model Repeated Measures|Multiple imputation used for missing data.|Treatment Difference = TNX-102 SL - Placebo|||0.0|-0.6|0.094
72541173|NCT01625286|144611645|SUPERIORITY|A hazard ratio \< 1 favours AZD5363|Hazard Ratio (HR)|0.8||||0.308|TWO_SIDED|80.0|0.6|1.06||2-sided p-value|Regression, Cox|Cox PH model including treatment and PIK3CA status as factors/covariates||||1.06|0.60|0.308
72541174|NCT01625286|144611646|SUPERIORITY||Mean Difference (Final Values)|-8.9||||0.081|TWO_SIDED|80.0|-17.1|-0.8||1-sided p-value|ANCOVA|||||-0.8|-17.1|0.081
72541175|NCT01625286|144611652|SUPERIORITY||Odds Ratio (OR)|1.53||||0.139|TWO_SIDED|80.0|0.93|2.54||1-sided p-value|Regression, Logistic|including treatment and PIK3CA status as factors/covariates||||2.54|0.93|0.139
72541176|NCT01625286|144611653|SUPERIORITY|A hazard ratio \< 1 favours AZD5363|Hazard Ratio (HR)|0.77||||0.482|TWO_SIDED|80.0|0.48|1.24||2-sided p-value|Log Rank|Cox PH model including treatment and PIK3CA status as factors/covariates||||1.24|0.48|0.482
72541177|NCT00828516|144611690|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.51|STANDARD_DEVIATION|0.96|<|0.001||95.0||||This was not adjusted for multiple comparisons|t-test, 2 sided||"MYMOP uses a 7-point scale, from 0 to 6, with 0 as good as it can be, and 6 as bad as it can be. Higher values represent a worse outcome."|There will be no improvement in MYMOP profile score after 6 acupuncture treatments.||||<0.001
72541178|NCT00828516|144611691|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.32|STANDARD_DEVIATION|0.94|<|0.001||95.0||||There will be no improvement in MYMOP profile score after 12 treatments|t-test, 2 sided||"MYMOP uses a 7-point scale, from 0 to 6, with 0 as good as it can be, and 6 as bad as it can be. Higher values represent a worse outcome."|||||<0.001
72541179|NCT01142466|144611701|SUPERIORITY_OR_OTHER|||||||0.1384|||||||Log Rank|||Two-sided log rank test with alpha equal to 0.05 was used as the appropriate nonparametric method to compare the two groups.||||0.1384
72541180|NCT01142466|144611702|SUPERIORITY_OR_OTHER|||||||0.2635||95.0|||||Fisher Exact|||||||0.2635
72541181|NCT04084028|144611708|SUPERIORITY|||||||0.91|||||||Mixed Models Analysis|||||||0.91
72541182|NCT04084028|144611709|SUPERIORITY|||||||0.03|||||||Mixed Models Analysis|||||||0.03
72409903|NCT00274716|144328243|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.2|STANDARD_ERROR_OF_MEAN|1.6||0.157|TWO_SIDED|95.0|-5.3|0.9|||ANCOVA|Treatment group and ambulatory blood pressure measurement (ABPM; yes or no) as class variables and baseline mean trough SiDBP as a continuous variable||||0.9|-5.3|0.157
72541183|NCT04084028|144611710|SUPERIORITY|||||||0.91|||||||Mixed Models Analysis|||||||0.91
72541184|NCT04084028|144611711|SUPERIORITY|||||||0.19|||||||Mixed Models Analysis|||||||.19
72541185|NCT04084028|144611712|SUPERIORITY|||||||0.77|||||||Mixed Models Analysis|||||||.77
72541186|NCT04084028|144611713|SUPERIORITY|||||||0.06|||||||Mixed Models Analysis|||||||.06
72541187|NCT00681824|144611730|SUPERIORITY_OR_OTHER|||||||0.7159||95.0|||||likelihood ratio of chi squared test|||||||0.7159
72541188|NCT03712137|144611800|SUPERIORITY||Responder Rate Difference|30.9||||0.0001|TWO_SIDED|95.0|15.33|46.54|||Multiple Imputation|The procedure used to perform Multiple Imputation is PROC MIANALYZE in SAS with normal approximation||||46.54|15.33|0.0001
72541189|NCT03712137|144611803|SUPERIORITY||Mean Difference (Final Values)|45.9|||<|0.0001|TWO_SIDED|95.0|40.45|51.28|||Paired T-test|||||51.28|40.45|<0.0001
72541190|NCT01430182|144611991|SUPERIORITY_OR_OTHER|||||||0.37|||||||t-test, 1 sided|unpaired||||||0.37
72541191|NCT00417027|144611992|SUPERIORITY_OR_OTHER||||||>|0.05||||||Bonferroni corrected for 6 comparisons|Wilcoxon (Mann-Whitney)|||||||>0.05
72541192|NCT00417027|144611992|SUPERIORITY_OR_OTHER|||||||0.005||95.0||||Bonferroni corrected for 6 comparisons|Wilcoxon (Mann-Whitney)|||||||0.005
72541193|NCT00417027|144611992|SUPERIORITY_OR_OTHER|||||||0.02||95.0||||Bonferroni corrected for 6 comparisons|Wilcoxon (Mann-Whitney)|||||||0.02
72541194|NCT00417027|144611993|SUPERIORITY_OR_OTHER|||||||0.54||95.0|||||Kruskal-Wallis|||||||0.54
72541195|NCT00417027|144611994|SUPERIORITY_OR_OTHER|||||||0.32||95.0|||||Kruskal-Wallis|||||||0.32
72541196|NCT00417027|144611995|SUPERIORITY_OR_OTHER|||||||0.69||95.0|||||Kruskal-Wallis|||||||0.69
72541197|NCT00417027|144611996|SUPERIORITY_OR_OTHER|||||||0.72||95.0||||Analysis applies to all rows.|Chi-squared, Corrected|||Analysis apply to all rows. Only 1 comparison was made between the groups in distribution of number of bolus doses.||||0.72
72541198|NCT00417027|144611997|SUPERIORITY_OR_OTHER|||||||0.41||95.0|||||Kruskal-Wallis|||||||0.41
72541199|NCT00417027|144611998|SUPERIORITY_OR_OTHER|||||||0.85||95.0|||||Kruskal-Wallis|||||||0.85
72541200|NCT01017029|144612005|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.482||||0.1043|TWO_SIDED|95.0|0.922|2.383|||Regression, Cox|||||2.383|0.922|0.1043
72541201|NCT01017029|144612007|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.847||||0.0398|TWO_SIDED|95.0|1.029|3.315|||Regression, Cox|||||3.315|1.029|0.0398
72541202|NCT01017029|144612009|SUPERIORITY_OR_OTHER|||||||0.0234|||||||Fisher Exact|||CMV infections||||0.0234
72541203|NCT01017029|144612010|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.403||||0.1966|TWO_SIDED|95.0|0.839|2.347|||Regression, Cox|||||2.347|0.839|0.1966
72541204|NCT02660385|144612036|SUPERIORITY||Effect Size|-0.6||||0.0002|TWO_SIDED||||||Generalized Linear Mixed Model (GLMM)|GLMM with random intercepts and unstructured covariances with changes within groups and time-group interactions to compare the intervention effects.||||||0.0002
72541205|NCT02660385|144612037|SUPERIORITY|||||||0.0723||||||GLMM with random intercepts and unstructured covariances with changes within groups and time-group interactions to compare the intervention effects.|GLMM|||||||0.0723
72541206|NCT02660385|144612038|SUPERIORITY||effect size|0.42||||0.011|TWO_SIDED||||||GLMM|GLMM with random intercepts and unstructured covariances with changes within groups and time-group interactions to compare the intervention effects.||||||0.0110
72541207|NCT02660385|144612039|SUPERIORITY||effect size|-0.7|||<|0.0001|TWO_SIDED|||||GLMM with random intercepts and unstructured covariances with changes within groups and time-group interactions to compare the intervention effects.|GLMM|||||||<0.0001
72541208|NCT02660385|144612040|SUPERIORITY||effect size|-0.12||||0.4356|TWO_SIDED|||||GLMM with random intercepts and unstructured covariances with changes within groups and time-group interactions to compare the intervention effects.|GLMM|||||||0.4356
72541209|NCT02660385|144612041|SUPERIORITY|||||||0.0148||||||The p value is from the group X time interaction adjusted at 12 months based on the false discovery rate|Mixed Models Analysis|||||||0.0148
72541210|NCT02660385|144612042|SUPERIORITY|||||||0.013||||||The p value is from the group X time interaction adjusted at 12 months based on the false discovery rate|Mixed Models Analysis|||||||0.0130
72541211|NCT02660385|144612043|SUPERIORITY|||||||0.013||||||The p value is from the group X time interaction adjusted at 12 months based on the false discovery rate|Mixed Models Analysis|||||||0.0130
72541212|NCT02660385|144612044|SUPERIORITY|||||||0.013||||||The p value is from the group X time interaction adjusted at 12 months based on the false discovery rate|Mixed Models Analysis|||||||0.0130
72541213|NCT02660385|144612045|SUPERIORITY|||||||0.6358||||||The p value is from the group X time interaction adjusted at 12 months based on the false discovery rate|Mixed Models Analysis|||||||0.6358
72541214|NCT02660385|144612046|SUPERIORITY||effect size|0.35||||0.0318|TWO_SIDED|||||GLMM with random intercepts and unstructured covariances with changes within groups and time-group interactions to compare the intervention effects.|GLMM|||||||0.0318
72541215|NCT02660385|144612047|SUPERIORITY|||||||0.2722||||||The p value is from the group X time interaction adjusted at 12 months based on the false discovery rate|Mixed Models Analysis|||||||0.2722
72541216|NCT02660385|144612048|SUPERIORITY||effect size|-0.27||||0.0954|TWO_SIDED|||||GLMM with random intercepts and unstructured covariances with changes within groups and time-group interactions to compare the intervention effects.|GLMM|||||||0.0954
72541217|NCT02660385|144612049|SUPERIORITY|||||||0.4222||||||The p value is from the group X time interaction adjusted at 12 months based on the false discovery rate|Mixed Models Analysis|||||||0.4222
72575729|NCT00468650|144677455|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-21.44|STANDARD_DEVIATION|36.06|<|0.001||95.0|-28.49|-14.39||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 LOCF minus baseline||-14.39|-28.49|<0.001
72541218|NCT02660385|144612050|SUPERIORITY||effect size|0.09||||0.5781|TWO_SIDED|||||GLMM with random intercepts and unstructured covariances with changes within groups and time-group interactions to compare the intervention effects.|GLMM|||||||0.5781
72541219|NCT02660385|144612051|SUPERIORITY|||||||0.1238||||||The p value is from the group X time interaction adjusted at 12 months based on the false discovery rate|Mixed Models Analysis|||||||0.1238
72541220|NCT02660385|144612052|SUPERIORITY||effect size|-0.3||||0.0558|TWO_SIDED|||||GLMM with random intercepts and unstructured covariances with changes within groups and time-group interactions to compare the intervention effects.|GLMM|||||||0.0558
72541221|NCT02660385|144612053|SUPERIORITY|||||||0.023||||||The p value is from the group X time interaction adjusted at 12 months based on the false discovery rate|Mixed Models Analysis|||||||0.0230
72541222|NCT02660385|144612054|SUPERIORITY||effect size|0.06||||0.4597|TWO_SIDED|||||GLMM with random intercepts and unstructured covariances with changes within groups and time-group interactions to compare the intervention effects.|GLMM|||||||0.4597
72541223|NCT02660385|144612055|SUPERIORITY|||||||0.1943||||||The p value is from the group X time interaction adjusted at 12 months based on the false discovery rate|Mixed Models Analysis|||||||0.1943
72541224|NCT02660385|144612056|SUPERIORITY||effect size|-0.23||||0.0027|TWO_SIDED|||||GLMM with random intercepts and unstructured covariances with changes within groups and time-group interactions to compare the intervention effects.|GLMM|||||||0.0027
72541225|NCT02660385|144612057|SUPERIORITY|||||||0.0792||||||The p value is from the group X time interaction adjusted at 12 months based on the false discovery rate|Mixed Models Analysis|||||||0.0792
72541226|NCT02660385|144612058|SUPERIORITY||effect size|0.13||||0.0656|TWO_SIDED|||||GLMM with random intercepts and unstructured covariances with changes within groups and time-group interactions to compare the intervention effects.|GLMM|||||||0.0656
72541227|NCT02660385|144612059|SUPERIORITY|||||||0.2174||||||The p value is from the group X time interaction adjusted at 12 months based on the false discovery rate|Mixed Models Analysis|||||||0.2174
72541228|NCT02660385|144612060|SUPERIORITY||effect size|0.07||||0.7028|TWO_SIDED|||||GLMM with random intercepts and unstructured covariances with changes within groups and time-group interactions to compare the intervention effects.|GLMM|||||||0.7028
72541229|NCT02660385|144612061|SUPERIORITY|||||||0.0509||||||The p value is from the group X time interaction adjusted at 12 months based on the false discovery rate|Mixed Models Analysis|||||||0.0509
72541230|NCT02660385|144612062|SUPERIORITY||Mean Difference (Final Values)|275.0|STANDARD_ERROR_OF_MEAN|1525.0||0.955|TWO_SIDED|95.0|-3288.0|2739.0|||t-test, 2 sided|||||2739|-3288|0.955
72541231|NCT02660385|144612063|SUPERIORITY|||||||0.013||||||The p value is from the group X time interaction adjusted at 12 months based on the false discovery rate|Mixed Models Analysis|||||||0.0130
72541232|NCT02660385|144612064|SUPERIORITY||effect size|-0.05||||0.7496|TWO_SIDED|||||GLMM with random intercepts and unstructured covariances with changes within groups and time-group interactions to compare the intervention effects.|GLMM|||||||0.7496
72541233|NCT02660385|144612065|SUPERIORITY||effect size|0.06||||0.3821|TWO_SIDED|||||GLMM with random intercepts and unstructured covariances with changes within groups and time-group interactions to compare the intervention effects.|GLMM|||||||0.3821
72541234|NCT02660385|144612066|SUPERIORITY|||||||0.7204||||||The p value is from the group X time interaction adjusted at 12 months based on the false discovery rate|Mixed Models Analysis|||||||0.7204
72575730|NCT00468650|144677455|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-21.86|STANDARD_DEVIATION|36.29|<|0.001||95.0|-29.03|-14.7||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 Endpoint minus baseline||-14.70|-29.03|<0.001
72575731|NCT00468650|144677456|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-6.79|STANDARD_DEVIATION|22.58||0.0021||95.0|-11.06|-2.52||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 4 minus Week 2||-2.52|-11.06|0.0021
72575732|NCT00468650|144677456|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-6.85|STANDARD_DEVIATION|23.02||0.0027||95.0|-11.26|-2.43||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 minus Week 2||-2.43|-11.26|0.0027
72575733|NCT00468650|144677456|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-7.43|STANDARD_DEVIATION|24.2||0.0015||95.0|-11.97|-2.9||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 LOCF minus Week 2||-2.90|-11.97|0.0015
72575734|NCT00468650|144677456|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-7.57|STANDARD_DEVIATION|24.4||0.0015||95.0|-12.18|-2.96||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 Endpoint minus Week 2||-2.96|-12.18|0.0015
72575735|NCT00468650|144677457|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-9.87|STANDARD_DEVIATION|34.44||0.0045||95.0|-16.6|-3.14||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 2 minus baseline||-3.14|-16.60|0.0045
72575736|NCT00468650|144677457|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-11.74|STANDARD_DEVIATION|32.8|<|0.001||95.0|-18.22|-5.27||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 4 minus baseline||-5.27|-18.22|<0.001
72541235|NCT02117479|144612087|OTHER||Hazard Ratio (HR)|0.969|||||TWO_SIDED|95.0|0.747|1.256||||||||1.256|0.747|
72627723|NCT00565409|144783952|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.83|||<|0.0001|TWO_SIDED|95.0|-16.2|-9.4||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 64||-9.4|-16.2|<0.0001
72627724|NCT00565409|144783952|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.32||||0.4437|TWO_SIDED|95.0|-4.7|2.1||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 64||2.1|-4.7|0.4437
72627725|NCT00565409|144783952|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.51|||<|0.0001|TWO_SIDED|95.0|-14.9|-8.1||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 64||-8.1|-14.9|<0.0001
72627726|NCT00565409|144783952|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.79|||<|0.0001|TWO_SIDED|95.0|-18.5|-11.1||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 72||-11.1|-18.5|<0.0001
72627727|NCT00565409|144783952|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.12||||0.096|TWO_SIDED|95.0|-6.8|0.6||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 72||0.6|-6.8|0.0960
72627728|NCT00565409|144783952|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.67|||<|0.0001|TWO_SIDED|95.0|-15.4|-8.0||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 72||-8.0|-15.4|<0.0001
72541236|NCT02117479|144612088|OTHER||Hazard Ratio (HR)|1.056|||||TWO_SIDED|95.0|0.827|1.348||||||||1.348|0.827|
72575737|NCT00468650|144677457|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-12.78|STANDARD_DEVIATION|33.56|<|0.001||95.0|-19.51|-6.05||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 minus baseline||-6.05|-19.51|<0.001
72575738|NCT00468650|144677457|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-13.13|STANDARD_DEVIATION|33.94|<|0.001||95.0|-19.76|-6.5||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 LOCF minus baseline||-6.50|-19.76|<0.001
72575739|NCT00468650|144677457|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-12.4|STANDARD_DEVIATION|33.13|<|0.001||95.0|-18.94|-5.86||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 Endpoint minus baseline||-5.86|-18.94|<0.001
72575740|NCT00468650|144677458|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-2.39|STANDARD_DEVIATION|22.0||0.2567||95.0|-6.55|1.77||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 4 minus Week 2||1.77|-6.55|0.2567
72575741|NCT00468650|144677458|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-1.91|STANDARD_DEVIATION|20.73||0.3435||95.0|-5.88|2.07||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 minus Week 2||2.07|-5.88|0.3435
72541237|NCT03398928|144612108|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
72541238|NCT03398928|144612109|SUPERIORITY||||||<|0.001|||||||Log Rank|||||||<0.001
72575742|NCT00468650|144677458|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-2.71|STANDARD_DEVIATION|22.28||0.2||95.0|-6.89|1.46||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 LOCF minus Week 2||1.46|-6.89|0.2000
72575743|NCT00468650|144677458|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-2.76|STANDARD_DEVIATION|22.48||0.2||95.0|-7.01|1.48||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 Endpoint minus Week 2||1.48|-7.01|0.2000
72409904|NCT00274716|144328243|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.1|STANDARD_ERROR_OF_MEAN|1.5||0.01|TWO_SIDED|95.0|-7.1|-1.0|||ANCOVA|Treatment group and ambulatory blood pressure measurement (ABPM; yes or no) as class variables and baseline mean trough SiDBP as a continuous variable||||-1.0|-7.1|0.010
72541239|NCT03398928|144612112|SUPERIORITY|||||||0.002||||||The statistical analysis applies to all the rows|Chi-squared|||||||0.002
72541240|NCT03398928|144612113|SUPERIORITY|||||||0.253|||||||Wilcoxon (Mann-Whitney)|||||||0.253
72541241|NCT00370396|144612118|NON_INFERIORITY_OR_EQUIVALENCE|Standardized asymptotic 95% confidence interval (CI) for the difference \[Synflorix-Synflorix minus Prevenar-Prevenar\] in terms of percentages of subjects reporting rectal fever \>39.0°C was computed.|Difference in percentage|-4.43|||||TWO_SIDED|95.0|-11.85|-0.21||||||Analysis aimed at demonstrating the non-inferiority of Synflorix™ vs Prevenar™ vaccine, both co-administered with Infanrix hexa™ vaccine, in terms of post-immunization febrile reactions with rectal fever \> 39.0°C.||-0.21|-11.85|
72575744|NCT00468650|144677459|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-10.82|STANDARD_DEVIATION|56.75||0.0558||95.0|-21.91|0.27||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 2 minus baseline||0.27|-21.91|0.0558
72575745|NCT00468650|144677459|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-29.16|STANDARD_DEVIATION|59.81|<|0.001||95.0|-40.96|-17.35||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 4 minus baseline||-17.35|-40.96|<0.001
72627729|NCT00565409|144783952|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.56|||<|0.0001|TWO_SIDED|95.0|-18.1|-11.0||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 80||-11.0|-18.1|<0.0001
72627730|NCT00565409|144783952|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.88||||0.2948|TWO_SIDED|95.0|-5.4|1.6||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 80||1.6|-5.4|0.2948
72541242|NCT03162354|144612239|OTHER||Odds Ratio (OR)|0.64||||0.11|TWO_SIDED|95.0|0.37|1.11||The threshold for statistical significance was p = 0.05.|Chi-squared||The direction of the comparison is from intervention sites to control sites.|We powered this hypothesis to detect a 17% increase (from 73% to 90%) in higher risk patients evaluated thoroughly for abuse at intervention sites, compared to baseline in prior PediBIRN studies. Generalized linear mixed-effects models were adopted to analyze 1,000 Monte Carlo datasets from simulation. For the target sample size of 304 higher risk patients (152 in each arm), the proportion of simulated datasets that yielded a statistically significant result for the primary hypothesis was 95.7%.||1.11|0.37|0.11
72541243|NCT03162354|144612240|OTHER||Odds Ratio (OR)|0.69||||0.49|TWO_SIDED|95.0|0.24|1.98||The threshold for statistical significance was p = 0.05.|Chi-squared||The direction of the comparison is from intervention sites to control sites.|||1.98|0.24|0.49
72575746|NCT00468650|144677459|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-30.79|STANDARD_DEVIATION|60.9|<|0.001||95.0|-43.0|-18.58||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 minus baseline||-18.58|-43.00|<0.001
72575747|NCT00468650|144677459|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-30.27|STANDARD_DEVIATION|61.7|<|0.001||95.0|-42.33|-18.21||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 LOCF minus baseline||-18.21|-42.33|<0.001
72575748|NCT00468650|144677459|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-30.87|STANDARD_DEVIATION|60.54|<|0.001||95.0|-42.82|-18.92||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 Endpoint minus baseline||-18.92|-42.82|<0.001
72575749|NCT00468650|144677460|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Net)|-18.36|STANDARD_DEVIATION|46.03|<|0.001||95.0|-27.05|-9.66||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 4 minus Week 2||-9.66|-27.05|<0.001
72575750|NCT00468650|144677460|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-22.16|STANDARD_DEVIATION|45.24|<|0.001||95.0|-30.84|-13.49||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 minus Week 2||-13.49|-30.84|<0.001
72575751|NCT00468650|144677460|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-20.28|STANDARD_DEVIATION|45.86|<|0.001||95.0|-28.87|-11.69||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 LOCF minus Week 2||-11.69|-28.87|<0.001
72575752|NCT00468650|144677460|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-20.65|STANDARD_DEVIATION|46.2|<|0.001||95.0|-29.38|-11.92||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 Endpoint minus Week 2||-11.92|-29.38|<0.001
72575753|NCT00468650|144677461|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|33.27|STANDARD_DEVIATION|41.43|<|0.001||95.0|25.17|41.36||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 2 minus baseline||41.36|25.17|<0.001
72575754|NCT00468650|144677461|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|61.45|STANDARD_DEVIATION|44.77|<|0.001||95.0|52.61|70.29||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 4 minus baseline||70.29|52.61|<0.001
72575755|NCT00468650|144677461|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|66.1|STANDARD_DEVIATION|45.15|<|0.001||95.0|57.05|75.16||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 minus baseline||75.16|57.05|<0.001
72575756|NCT00468650|144677461|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|64.84|STANDARD_DEVIATION|45.7|<|0.001||95.0|55.91|73.77||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 LOCF minus baseline||73.77|55.91|<0.001
72575757|NCT00468650|144677461|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|65.13|STANDARD_DEVIATION|45.56|<|0.001||95.0|56.14|74.12||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 Endpoint minus baseline||74.12|56.14|<0.001
72575758|NCT00468650|144677462|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|27.53|STANDARD_DEVIATION|40.19|<|0.001||95.0|19.94|35.13||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 4 minus Week 2||35.13|19.94|<0.001
72575759|NCT00468650|144677462|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|30.92|STANDARD_DEVIATION|41.9|<|0.001||95.0|22.89|38.95||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 minus Week 2||38.95|22.89|<0.001
72575760|NCT00468650|144677462|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|30.43|STANDARD_DEVIATION|41.88|<|0.001||95.0|22.59|38.27||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 LOCF minus Week 2||38.27|22.59|<0.001
72541244|NCT03162354|144612241|OTHER||Odds Ratio (OR)|1.88||||0.22|TWO_SIDED|95.0|0.69|5.13||The threshold for statistical significance was p = 0.05.|Chi-squared||The direction of the comparison is from intervention sites to control sites.|||5.13|0.69|0.22
72575761|NCT00468650|144677462|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|30.98|STANDARD_DEVIATION|42.06|<|0.001||95.0|23.04|38.93||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 Endpoint minus Week 2||38.93|23.04|<0.001
72575762|NCT00468650|144677463|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|22.45|STANDARD_DEVIATION|46.1|<|0.001||95.0|13.44|31.46||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 2 minus baseline||31.46|13.44|<0.001
72575763|NCT00468650|144677463|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|32.3|STANDARD_DEVIATION|42.15|<|0.001||95.0|23.97|40.62||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 4 minus baseline||40.62|23.97|<0.001
72575764|NCT00468650|144677463|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|35.31|STANDARD_DEVIATION|43.52|<|0.001||95.0|26.59|44.04||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 minus baseline||44.04|26.59|<0.001
72409905|NCT00274716|144328243|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.2|STANDARD_ERROR_OF_MEAN|1.6||0.042|TWO_SIDED|95.0|-6.4|-0.1|||ANCOVA|Treatment group and ambulatory blood pressure measurement (ABPM; yes or no) as class variables and baseline mean trough SiDBP as a continuous variable||||-0.1|-6.4|0.042
72541245|NCT03162354|144612242|OTHER||Odds Ratio (OR)|0.48||||0.01|TWO_SIDED|95.0|0.27|0.85||The threshold for statistical significance was p = 0.05.|Chi-squared||The direction of the comparison is from intervention sites to control sites.|||0.85|0.27|0.01
72541246|NCT03162354|144612243|OTHER||Odds Ratio (OR)|1.09||||0.84|TWO_SIDED|95.0|0.46|2.6||The threshold for statistical significance was p = 0.05.|Chi-squared||The direction of the comparison is from intervention sites to control sites.|||2.60|0.46|0.84
72541247|NCT03162354|144612244|OTHER||Odds Ratio (OR)|1.84||||0.05|TWO_SIDED|95.0|1.0|3.38||The threshold for statistical significance was p = 0.05.|Chi-squared||The direction of the comparison is from intervention sites to control sites.|||3.38|1.00|0.05
72541248|NCT03162354|144612245|OTHER||Odds Ratio (OR)|1.22||||0.71|TWO_SIDED|95.0|0.43|3.49||The threshold for statistical significance was p = 0.05.|Chi-squared||The direction of the comparison is from intervention sites to control sites.|||3.49|0.43|0.71
72541249|NCT03162354|144612246|OTHER||Odds Ratio (OR)|1.04||||0.86|TWO_SIDED|95.0|0.7|1.53||The threshold for statistical significance was p = 0.05.|Chi-squared||The direction of the comparison is from intervention sites to control sites.|||1.53|0.70|0.86
72541250|NCT03162354|144612247|OTHER||Odds Ratio (OR)|2.02||||0.01|TWO_SIDED|95.0|1.16|3.52||The threshold for statistical significance was p = 0.05.|Chi-squared||The direction of the comparison is from baseline prior studies to the cluster randomized trial|||3.52|1.16|0.01
72541251|NCT03162354|144612248|OTHER||Odds Ratio (OR)|0.42|||<|0.001|TWO_SIDED|95.0|0.26|0.67||The threshold for statistical significance was p = 0.05.|Chi-squared||The direction of the comparison is from baseline in prior studies to the cluster randomized trial.|||0.67|0.26|<.001
72541252|NCT03162354|144612249|OTHER||Odds Ratio (OR)|0.46||||0.14|TWO_SIDED|95.0|0.16|1.31||The threshold for statistical significance was p = 0.05.|Chi-squared||The direction of the comparison is from baseline in prior PediBIRN studies to the clinical trial.|||1.31|0.16|0.14
72541253|NCT03162354|144612251|OTHER||Odds Ratio (OR)|0.74||||0.57|TWO_SIDED|95.0|0.27|2.05||The threshold for statistical significance was p = 0.05.|Chi-squared||The direction of the comparison is from intervention sites to control sites.|||2.05|0.27|0.57
72541254|NCT03162354|144612252|OTHER||Odds Ratio (OR)|0.63||||0.04|TWO_SIDED|95.0|0.4|0.99||The threshold for statistical significance was p = 0.05.|Chi-squared||The direction of the comparison is from intervention sites to control sites.|||0.99|0.40|0.04
72541255|NCT03909971|144612255|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||||||<0.0001
72541256|NCT04542330|144612277|SUPERIORITY||||||<|0.05|||||||Andersen-Gill Cox|||Acute infection was analysed as recurrent events using an Andersen-Gill Cox proportional hazards regression model with time since inclusion as underlying time scale. The analysis was done for the composite outcome and for all subcomponents separately, presenting Hazard Ratios (HR) with 95% Confidence Intervals (CI) for each. For all recurrent outcomes, a wash-out period of 14 days was used to define new events.||||< 0.05
72541257|NCT04542330|144612278|SUPERIORITY||||||<|0.05|||||||Regression, Cox|||Verified SARS-CoV-2 infection (first event) and all-cause hospitalisation (first event) was analysed using standard Cox proportional hazards models, but otherwise as described for primary outcome.||||< 0.05
72541258|NCT04542330|144612279|SUPERIORITY||||||<|0.05|||||||Andersen-Gill Cox|||The secondary outcome, self-reported respiratory symptoms, was analysed the same way as the primary outcome (recurrent events).||||< 0.05
72541259|NCT04542330|144612280|SUPERIORITY||||||<|0.05|||||||Regression, Cox|||Verified SARS-CoV-2 infection (first event) and all-cause hospitalisation (first event) was analysed using standard Cox proportional hazards models, but otherwise as described for the primary outcome.||||< 0.05
72541260|NCT04583592|144612281|SUPERIORITY|||||||0.787||||||\<0.05|Chi-squared|||||||0.787
72541261|NCT01164137|144612303|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.07||||0.87|TWO_SIDED|95.0|-0.98|0.84|||t-test, 2 sided|||||.84|-.98|.87
72541262|NCT01164137|144612304|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.63||||0.32|TWO_SIDED|95.0|-0.62|1.88|||t-test, 2 sided|||||1.88|-.62|.32
72541263|NCT01164137|144612305|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.21||||0.18|TWO_SIDED|95.0|-0.57|3.01|||t-test, 2 sided|||||3.01|-.57|.18
72409906|NCT00274716|144328243|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.0|STANDARD_ERROR_OF_MEAN|1.6||0.517|TWO_SIDED|95.0|-2.1|4.1|||ANCOVA|Treatment group and ambulatory blood pressure measurement (ABPM; yes or no) as class variables and baseline mean trough SiDBP as a continuous variable||||4.1|-2.1|0.517
72409907|NCT00274716|144328243|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8|STANDARD_ERROR_OF_MEAN|1.6||0.602|TWO_SIDED|95.0|-3.9|2.3|||ANCOVA|Treatment group and ambulatory blood pressure measurement (ABPM; yes or no) as class variables and baseline mean trough SiDBP as a continuous variable||||2.3|-3.9|0.602
72541264|NCT01164137|144612306|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.71||||0.11|TWO_SIDED|95.0|-0.39|3.81|||t-test, 2 sided|||||3.81|-.39|.11
72541265|NCT01164137|144612307|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.85||||0.13|TWO_SIDED|95.0|-0.56|4.27|||t-test, 2 sided|||||4.27|-.56|.13
72541266|NCT04523831|144612308|SUPERIORITY||Cox Proportional Hazard|0.53|||<|0.03|TWO_SIDED|95.0|0.3|0.96|||Regression, Linear|||||0.96|0.30|<0.03
72541267|NCT04523831|144612309|SUPERIORITY||Cox Proportional Hazard|0.51|||<|0.004|TWO_SIDED|95.0|0.32|0.8|||Regression, Logistic|||||0.80|0.32|<0.004
72541268|NCT04523831|144612310|SUPERIORITY||Cox Proportional Hazard|0.45|||<|0.013|TWO_SIDED|95.0|0.23|0.85|||Regression, Logistic|||||0.85|0.23|<0.013
72541269|NCT04523831|144612311|SUPERIORITY||Cox Proportional Hazard|0.58|||<|0.001|TWO_SIDED|95.0|0.44|0.81|||Regression, Logistic|||||0.81|0.44|<0.001
72541270|NCT00430638|144612324|SUPERIORITY_OR_OTHER||||||<|0.0001||||||No multiplicity adjustments|ANCOVA|The ANCOVA model included randomized treatment and baseline cuff blood pressure stage as factors and study baseline systolic BP value as a covariate.||Null hypothesis: For the entire efficacy population, Olmesartan had the same effect on change from baseline in systolic blood pressure at week 12 as Placebo. A statistical test was evaluated at the 2 sided significance level of 5% without adjustment for multiple comparisons.||||<0.0001
72541271|NCT00430638|144612325|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|The ANCOVA Model included randomized treatment and baseline cuff BP stage as factors and study baseline diastolic BP as a covariate.||Null hypothesis: For the entire efficacy population, Olmesartan had the same effect on change from baseline in diastolic blood pressure at week 12 as Placebo. A statistical test was evaluated at the 2 sided significance level of 5% without adjustment for multiple comparisons.||||<0.0001
72541272|NCT00430638|144612326|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||Null hypothesis (male systolic blood pressure (SBP)): For the male efficacy population, Olmesartan had the same effect on change from baseline in systolic blood pressure at week 12 as Placebo. A statistical test was evaluated at the 2 sided significance level of 5% without adjustment for multiple comparisons.||||<0.0001
72575765|NCT00468650|144677463|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|34.57|STANDARD_DEVIATION|43.48|<|0.001||95.0|26.07|43.07||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 LOCF minus baseline||43.07|26.07|<0.001
72575766|NCT00468650|144677463|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|34.26|STANDARD_DEVIATION|43.29|<|0.001||95.0|25.72|42.81||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 Endpoint minus baseline||42.81|25.72|<0.001
72575767|NCT00468650|144677464|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|9.18|STANDARD_DEVIATION|29.45||0.0014||95.0|3.61|14.74||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 4 minus Week 2||14.74|3.61|0.0014
72575768|NCT00468650|144677464|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|8.75|STANDARD_DEVIATION|29.26||0.0025||95.0|3.15|14.36||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 minus Week 2||14.36|3.15|0.0025
72575769|NCT00468650|144677464|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|10.15|STANDARD_DEVIATION|31.11|<|0.001||95.0|4.32|15.97||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 LOCF minus Week 2||15.97|4.32|<0.001
72575770|NCT00468650|144677464|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|10.33|STANDARD_DEVIATION|31.36|<|0.001||95.0|4.41|16.26||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 Endpoint minus Week 2||16.26|4.41|<0.001
72575771|NCT02639052|144677465|SUPERIORITY_OR_OTHER|||||||0.9704||||||Significance defined a priori as p\<0.05. P-values not adjusted for multiple comparisons.|ANOVA with Repeated Measures|||Baseline assessment of itch VAS after itch induction but prior to Botox or saline application. Analyzed using ANOVA with repeated measures to compare main effects of treatment (Botox vs saline) and time, and interaction effect between treatment and time.||||0.9704
72575772|NCT02639052|144677466|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Statistical significance defined a priori as p\<0.05. P-values have not been adjusted for multiple comparisons.|ANOVA with Repeated Measures|||1 week (Visit 2) was the first assessment of itch VAS after itch induction after Botox or saline application. Analyzed using ANOVA with repeated measures to compare main effects of treatment (Botox vs saline) and time, and interaction effect between treatment and time.||||<0.0001
72575773|NCT02639052|144677467|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Statistically significant difference in mean itch VAS between the two treatments (Botox mean=2.45 versus saline mean=3.20, p\<0.0001). Statistical significance defined a priori as p\<0.05. P-values have not been adjusted for multiple comparisons.|ANOVA with Repeated Measures|||1 month (Visit 3) was the second assessment of itch VAS after itch induction after Botox or saline application. Analyzed using ANOVA with repeated measures to compare main effects of treatment (Botox vs saline) and time, and interaction effect between treatment and time.||||<0.0001
72575774|NCT02639052|144677468|SUPERIORITY_OR_OTHER|||||||0.0004||||||Statistical significance defined a priori as p\<0.05. P-values have not been adjusted for multiple comparisons.|ANOVA with Repeated Measures|Analyzed using ANOVA with repeated measures to compare treatment (Botox vs saline), time, and interaction effect between treatment \& time||3 months (Visit 4) was the third assessment of itch VAS after itch induction after Botox or saline application. Analyzed using ANOVA with repeated measures to compare main effects of treatment (Botox vs saline) and time, and interaction effect between treatment and time.||||0.0004
72575775|NCT02639052|144677469|SUPERIORITY_OR_OTHER|||||||0.1306||||||Statistical significance defined a priori as p\<0.05.|ANOVA with Repeated Measures|||Analyzed using ANOVA with repeated measures to compare main effects of treatment (Botox vs saline) and visit, and interaction effect between treatment and visit.||||0.1306
72575776|NCT02730351|144677481|OTHER||Mean Difference (Final Values)|-1.69||||0.109|TWO_SIDED|95.0|-3.76|0.39||Mixed model repeated measures analysis adjusted for fixed effects of treatment, sex, age, treatment period, smoking history, period Baseline FEV1 and the mean of the two period Baseline FEV1 values. Subject is fitted as a random effect.|Mixed Models Analysis|||||0.39|-3.76|0.109
72409908|NCT00274716|144328244|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-4.9|STANDARD_ERROR_OF_MEAN|2.4||0.046|TWO_SIDED|95.0|-9.7|-0.1|||ANCOVA|Treatment group and ambulatory blood pressure measurement (ABPM; yes or no) as class variables and baseline mean trough SiDBP as a continuous variable||||-0.1|-9.7|0.046
72541273|NCT00430638|144612326|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||Null hypothesis (Males - diastolic blood pressure (DBP)): For the male efficacy population, Olmesartan had the same effect on change from baseline in diastolic blood pressure at week 12 as Placebo. A statistical test was evaluated at the 2 sided significance level of 5% without adjustment for multiple comparisons.||||<0.0001
72541274|NCT00430638|144612327|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||Null hypothesis (Systolic blood pressure (SBP) - females): For the female efficacy population, Olmesartan had the same effect on change from baseline in systolic blood pressure at week 12 as Placebo. A statistical test was evaluated at the 2 sided significance level of 5% without adjustment for multiple comparisons.||||<0.0001
72541275|NCT00430638|144612327|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||Null hypothesis (Diastolic blood pressure (DBP) - females): For the female efficacy population, Olmesartan had the same effect on change from baseline in DBP at week 12 as Placebo. A statistical test was evaluated at the 2 sided significance level of 5% without adjustment for multiple comparisons.||||<0.0001
72541276|NCT00430638|144612328|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||Null hypothesis(Systolic blood pressure (SBP) - less than 65 years of age): For the efficacy population \< 65 years of age, Olmesartan had the same effect on change from baseline in SBP at week 12 as Placebo. A statistical test was evaluated at the 2 sided significance level of 5% without adjustment for multiple comparisons.||||<0.0001
72541277|NCT00430638|144612328|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||Null hypothesis (Diastolic blood pressure (DBP) - less than 65 years of age): For the efficacy population \< 65 years of age, Olmesartan had the same effect on change from baseline in DBP at week 12 as Placebo. A statistical test was evaluated at the 2 sided significance level of 5% without adjustment for multiple comparisons.||||<0.0001
72541278|NCT00430638|144612329|SUPERIORITY_OR_OTHER|||||||0.0125||95.0|||||ANCOVA|||Null hypothesis (Systolic blood pressure (SBP) - \> or equal to 65 years old): For the efficacy population \> or = to 65 years of age, Olmesartan had the same effect on change from baseline in SBP at week 12 as Placebo. A statistical test was evaluated at the 2 sided significance level of 5% without adjustment for multiple comparisons.||||0.0125
72541279|NCT00430638|144612329|SUPERIORITY_OR_OTHER|||||||0.0006||95.0|||||ANCOVA|||Null hypothesis (Diastolic blood pressure (DBP) \> or equal to 65): For the efficacy population \> or = to 65 years of age, Olmesartan had the same effect on change from baseline in DBP at week 12 as Placebo. A statistical test was evaluated at the 2 sided significance level of 5% without adjustment for multiple comparisons.||||0.0006
72541280|NCT00430638|144612330|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||Null hypothesis (Systolic blood pressure (SBP) - Black participants): For the Black efficacy population, Olmesartan had the same effect on change from baseline in SBP at week 12 as Placebo. A statistical test was evaluated at the 2 sided significance level of 5% without adjustment for multiple comparisons||||<0.0001
72541281|NCT00430638|144612330|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||Null hypothesis (Diastolic blood pressure (DBP) - Black participants): For the Black efficacy population, Olmesartan had the same effect on change from baseline in DBP at week 12 as Placebo. A statistical test was evaluated at the 2 sided significance level of 5% without adjustment for multiple comparisons||||<0.0001
72541282|NCT00430638|144612331|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||Null hypothesis(Systolic blood pressure (SBP) - non-Black participants): For the Non-Black efficacy population, Olmesartan had the same effect on change from baseline in SBP at week 12 as Placebo. A statistical test was evaluated at the 2 sided significance level of 5% without adjustment for multiple comparisons||||<0.0001
72541283|NCT00430638|144612331|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||Null hypothesis(Diastolic blood pressure (DBP) - non-Black participants): For the Non-Black efficacy population, Olmesartan had the same effect on change from baseline in DBP at week 12 as Placebo. A statistical test was evaluated at the 2 sided significance level of 5% without adjustment for multiple comparisons||||<0.0001
72575777|NCT02730351|144677482|OTHER||Mean Difference (Final Values)|-2.15||||0.051|TWO_SIDED|95.0|-4.31|0.01||Mixed model repeated measures analysis adjusted for fixed effects of treatment, sex, age, treatment period, smoking history, period Baseline FEV1 and the mean of the two period Baseline FEV1 values. Subject is fitted as a random effect.|Mixed Models Analysis|||||0.01|-4.31|0.051
72575778|NCT02730351|144677483|OTHER||Odds Ratio (OR)|1.34||||0.266|TWO_SIDED|95.0|0.8|2.26||Repeated measures logistic regression model with parameters estimated using the Generalized Estimating Equation method. Covariates of treatment, sex, age, treatment period, and period baseline FEV1 were included.|Regression, Logistic||12 hrs: modeling the odds of having FEV1 \>/=95% of pre exercise FEV1 at each of the two time points.|||2.26|0.80|0.266
72409909|NCT00274716|144328244|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.9|STANDARD_ERROR_OF_MEAN|2.4||0.108|TWO_SIDED|95.0|-8.7|0.9|||ANCOVA|Treatment group and ambulatory blood pressure measurement (ABPM; yes or no) as class variables and baseline mean trough SiDBP as a continuous variable||||0.9|-8.7|0.108
72541284|NCT00430638|144612332|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||Null hypothesis(Systolic blood pressure (SBP) - Stage 1 hypertensive participants): For the Stage 1 efficacy population, Olmesartan had the same effect on change from baseline in SBP at week 12 as Placebo. A statistical test was evaluated at the 2 sided significance level of 5% without adjustment for multiple comparisons||||<0.0001
72541285|NCT00430638|144612332|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||Null hypothesis (Diastolic blood pressure (DBP) - Stage 1 hypertensive participants): For the Stage 1 efficacy population, Olmesartan had the same effect on change from baseline in DBP at week 12 as Placebo. A statistical test was evaluated at the 2 sided significance level of 5% without adjustment for multiple comparisons||||<0.0001
72541286|NCT00430638|144612333|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||Null hypothesis (Systolic blood pressure (SBP) - Stage 2 hypertensive participants): For the Stage 2 efficacy population, Olmesartan had the same effect on change from baseline in SBP at week 12 as Placebo. A statistical test was evaluated at the 2 sided significance level of 5% without adjustment for multiple comparisons||||<0.0001
72575779|NCT02730351|144677483|OTHER||Odds Ratio (OR)|1.37||||0.322|TWO_SIDED|95.0|0.73|2.58||Repeated measures logistic regression model with parameters estimated using the Generalized Estimating Equation method|Regression, Logistic||23 hrs: modeling the odds of having FEV1 \>/=95% of pre exercise FEV1 at each of the two time points.|||2.58|0.73|0.322
72627731|NCT00565409|144783952|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.68|||<|0.0001|TWO_SIDED|95.0|-16.2|-9.1||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 80||-9.1|-16.2|<0.0001
72627732|NCT00565409|144783952|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.16|||<|0.0001|TWO_SIDED|95.0|-16.9|-9.5||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 88||-9.5|-16.9|<0.0001
72541287|NCT00430638|144612333|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||Null hypothesis (Diastolic blood pressure (DBP) - Stage 2 hypertensive participants): For the Stage 2 efficacy population, Olmesartan had the same effect on change from baseline in DBP at week 12 as Placebo. A statistical test was evaluated at the 2 sided significance level of 5% without adjustment for multiple comparisons||||<0.0001
72541288|NCT02623426|144612336|SUPERIORITY||Ratio of the proportion of baseline|1.36|||<|0.001|TWO_SIDED|95.0|1.19|1.56||A Bonferroni correction was used to adjust for the co-primary hypotheses;a two-sided type I error rate of 0.05/2 = 0.025 was used to determine statistical significance for the two pairwise comparisons (Ozurdex vs Methotrexate and Ozurdex vs Lucentis)|mixed effects model||The treatment effect is the ratio of the proportions of baseline retinal thickness (Methotrexate/Ozurdex). Values greater than 1 indicate less reduction in retinal thickness in the Methotrexate treated group compared to Ozurdex|A sample size of 240 was calculated to provide 91% power to detect a 25% reduction for Ozurdex, a 38% reduction for Methotrexate and Lucentis assuming a standard deviation of 0.33, 25% with bilateral disease, between-eye correlation of 0.4, 10% loss to follow-up, and a two-sided type 1 error rate of 0.025 for each pairwise comparison.||1.56|1.19|<0.001
72575780|NCT02730351|144677484|OTHER||Mean Difference (Final Values)|-0.65||||0.342|TWO_SIDED|95.0|-2.01|0.71||Mixed model repeated measures analysis adjusted for fixed effects of treatment, sex, age, treatment period, smoking history, period Baseline FEV1 and the mean of the two period Baseline FEV1 values. Subject is fitted as a random effect.|Mixed Models Analysis||12 hrs post-dose|||0.71|-2.01|0.342
72575781|NCT02730351|144677484|OTHER||Mean Difference (Final Values)|-1.75||||0.041|TWO_SIDED|95.0|-3.42|-0.07||Mixed model repeated measures analysis adjusted for fixed effects of treatment, sex, age, treatment period, smoking history, period Baseline FEV1 and the mean of the two period Baseline FEV1 values.|Mixed Models Analysis||23 hrs post-dose|||-0.07|-3.42|0.041
72575782|NCT00838435|144677485|OTHER|Coefficient estimates from a random coefficient model and associated p-values.|Slope|-0.5768|||||TWO_SIDED|95.0|-1.6004|0.4468|||||The slope shown above is based on a 2-year window.|A random coefficient model was used to calculate the slope (per year) of FSIQ over the entire study period. Factors in the model included visit and testing sequence, with change in FSIQ score as the dependent variable. Random terms include both intercept and visit. The treatment was considered successful if the lower 95% confidence limit of the mean change excluded a decline of greater than 5 points over a 2-year window.||0.4468|-1.6004|
72575783|NCT02472223|144677527|SUPERIORITY||Median Difference (Final Values)|90.0||||0.02|TWO_SIDED|||||p-value is not adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|||||||0.02
72575784|NCT03201965|144677548|SUPERIORITY||Odds Ratio (OR)|5.13|||<|0.0001|TWO_SIDED|95.0|3.22|8.16|||Cochran-Mantel-Haenszel|||||8.16|3.22|<0.0001
72575785|NCT01758588|144677565|OTHER||||||||||||||||||A statistical comparison and analysis of the clinical improvement (CI) proportions cannot be made because the sample size (n=5 in treatment arm, n=3 in observation arm) is too small|||
72575786|NCT04428333|144677586|SUPERIORITY|Other|Hazard Ratio (HR)|2.16||||0.74|TWO_SIDED|95.0|0.2|23.87||Nominal p-value was calculated based on the one sided log-rank test, stratified by stratified by PD-L1 expression (CPS ≥20 vs. 1≤ CPS \<20 vs. CPS \<1) and HPV status (oropharynx HPV positive vs oropharynx HPV negative/unknown and non-oropharynx).|Stratified Cox proportional hazard model|||The hazard ratio and corresponding 2-sided 95% confidence interval was calculated from the cox regression model with Efron's method of tie handling with treatment as a covariate and stratified by PD-L1 expression (CPS ≥20 vs. 1≤ CPS \<20 vs. CPS \<1) and Human Papilloma Virus (HPV) status (positive vs. negative). Participants with oropharynx HPV negative/unknown and non-oropharyngeal tumors were combined as the HPV negative group.||23.87|0.20|0.740
72575787|NCT04428333|144677587|SUPERIORITY|Other|Hazard Ratio (HR)|2.16||||0.74|TWO_SIDED|95.0|0.2|23.87||Nominal p-value was calculated based on the one sided log-rank test, stratified by stratified by PD-L1 expression (CPS ≥20 vs. 1≤ CPS \<20) and HPV status (oropharynx HPV positive vs oropharynx HPV negative/unknown and non-oropharynx).|Stratified Cox proportional hazard model|||The hazard ratio and corresponding 2-sided 95% confidence interval was calculated from the cox regression model with Efron's method of tie handling with treatment as a covariate and stratified by PD-L1 expression (CPS ≥ 20 vs 1≤ CPS\<20) and HPV status (positive vs. negative). Participants with oropharynx HPV negative/unknown and non-oropharyngeal tumors were combined as the HPV negative group.||23.87|0.20|0.740
72575788|NCT04428333|144677588|SUPERIORITY|Other|Hazard Ratio (HR)|0.7||||0.284|TWO_SIDED|95.0|0.2|2.43||Nominal p-value was calculated based on the one sided log-rank test, stratified by stratified by PD-L1 expression (CPS ≥20 vs. 1≤ CPS \<20 vs. CPS \<1) and HPV status (oropharynx HPV positive vs oropharynx HPV negative/unknown and non-oropharynx).|Stratified Cox proportional hazard model|||The hazard ratio and corresponding 2-sided 95% confidence interval was calculated from the cox regression model with Efron's method of tie handling with treatment as a covariate and stratified by PD-L1 expression (CPS ≥20 vs. 1≤ CPS \<20 vs. CPS \<1) and HPV status (positive vs. negative). Participants with oropharynx HPV negative/unknown and non-oropharyngeal tumors were combined as the HPV negative group.||2.43|0.20|0.284
72575789|NCT04428333|144677589|SUPERIORITY|Other|Hazard Ratio (HR)|0.7||||0.284|TWO_SIDED|95.0|0.2|2.43||Nominal p-value was calculated based on the one sided log-rank test, stratified by stratified by PD-L1 expression (CPS ≥20 vs. 1≤ CPS \<20) and HPV status (oropharynx HPV positive vs oropharynx HPV negative/unknown and non-oropharynx).|Stratified Cox proportional hazard model|||The hazard ratio and corresponding 2-sided 95% confidence interval was calculated from the cox regression model with Efron's method of tie handling with treatment as a covariate and stratified by PD-L1 expression (CPS≥20 vs 1≤CPS\<20) and HPV status (positive vs. negative). Participants with oropharynx HPV negative/unknown and non-oropharyngeal tumors were combined as the HPV negative group.||2.43|0.20|0.284
72409910|NCT00274716|144328244|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.1|STANDARD_ERROR_OF_MEAN|2.5||0.099|TWO_SIDED|95.0|-9.0|0.8|||ANCOVA|Treatment group and ambulatory blood pressure measurement (ABPM; yes or no) as class variables and baseline mean trough SiDBP as a continuous variable||||0.8|-9.0|0.099
72409911|NCT00274716|144328244|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8|STANDARD_ERROR_OF_MEAN|2.5||0.752|TWO_SIDED|95.0|-5.7|4.1|||ANCOVA|Treatment group and ambulatory blood pressure measurement (ABPM; yes or no) as class variables and baseline mean trough SiDBP as a continuous variable||||4.1|-5.7|0.752
72409912|NCT00274716|144328244|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|2.5||0.941|TWO_SIDED|95.0|-4.7|5.0|||ANCOVA|Treatment group and ambulatory blood pressure measurement (ABPM; yes or no) as class variables and baseline mean trough SiDBP as a continuous variable||||5.0|-4.7|0.941
72409913|NCT00274716|144328245|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-1.4|STANDARD_ERROR_OF_MEAN|0.4|<|0.001|TWO_SIDED|95.0|-2.2|-0.7|||ANCOVA|Treatment group and ambulatory blood pressure measurement (ABPM; yes or no) as class variables and baseline weight as a continuous variable||||-0.7|-2.2|<0.001
72409914|NCT00274716|144328245|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.1|STANDARD_ERROR_OF_MEAN|0.4||0.003|TWO_SIDED|95.0|-1.9|-0.4|||ANCOVA|Treatment group and ambulatory blood pressure measurement (ABPM; yes or no) as class variables and baseline weight as a continuous variable||||-0.4|-1.9|0.003
72541289|NCT02623426|144612336|SUPERIORITY||Ratio of the proportion of BL|1.22||||0.012|TWO_SIDED|95.0|1.04|1.43||A Bonferroni correction was used to adjust for the co-primary hypotheses;a two-sided type I error rate of 0.05/2 = 0.025 was used to determine statistical significance for the two pairwise comparisons (Ozurdex vs Methotrexate and Ozurdex vs Lucentis)|mixed effects model||The treatment effect is the ratio of the proportions of baseline retinal thickness (Lucentis/Ozurdex) at 12 weeks. Values greater than 1 indicate less reduction in retinal thickness in the Lucentis treated group compared to Ozurdex|A sample size of 240 was calculated to provide 91% power to detect a 25% reduction for Ozurdex, a 38% reduction for methotrexate and Lucentis assuming a standard deviation of 0.33, 25% with bilateral disease, between-eye correlation of 0.4, 10% loss to follow-up, and a two-sided type 1 error rate of 0.025 for each pairwise comparison.||1.43|1.04|0.012
72575790|NCT04428333|144677592|OTHER||Difference in Percentage|-4.8|||||TWO_SIDED|95.0|-20.8|11.3||||||The comparison between treatment groups was based on the stratified Miettinen \& Nurminen method with strata weighting by sample size and a single treatment covariate. Stratification factors included PD-L1 expression (CPS ≥20 vs. 1≤ CPS \<20 vs. CPS \<1) and HPV status (positive vs. negative). Participants with oropharynx HPV negative/unknown and non-oropharyngeal tumors were combined as the HPV negative group.||11.3|-20.8|
72575791|NCT04428333|144677593|OTHER||Difference in Percentage|-5.1|||||TWO_SIDED|95.0|-21.4|11.3||||||The comparison between treatment groups was based on the stratified Miettinen \& Nurminen method with strata weighting by sample size and a single treatment covariate. Stratification factors included PD-L1 expression (CPS≥20 vs 1≤CPS\<20) and HPV status (positive vs. negative). Participants with oropharynx HPV negative/unknown and non-oropharyngeal tumors were combined as the HPV negative group.||11.3|-21.4|
72575792|NCT04428333|144677594|OTHER||Difference in Percentage|-4.8|||||TWO_SIDED|95.0|-22.2|13.1||||||The comparison between treatment groups was based on the stratified Miettinen \& Nurminen method with strata weighting by sample size and a single treatment covariate. Stratification factors included PD-L1 expression (CPS ≥20 vs. 1≤ CPS \<20 vs. CPS \<1) and HPV status (positive vs. negative). Participants with oropharynx HPV negative/unknown and non-oropharyngeal tumors were combined as the HPV negative group.||13.1|-22.2|
72575793|NCT04428333|144677595|OTHER||Difference in Percentage|-5.1|||||TWO_SIDED|95.0|-22.8|13.3||||||The comparison between treatment groups was based on the stratified Miettinen \& Nurminen method with strata weighting by sample size and a single treatment covariate. Stratification factors included PD-L1 expression (CPS ≥20 vs. 1≤ CPS \<20) and HPV status (positive vs. negative). Participants with oropharynx HPV negative/unknown and non-oropharyngeal tumors were combined as the HPV negative group.||13.3|-22.8|
72575794|NCT04428333|144677612|SUPERIORITY|Other|Hazard Ratio (HR)|0.85||||0.329|TWO_SIDED|95.0|0.42|1.71||Nominal p-value was calculated based on the one sided log-rank test, stratified by stratified by PD-L1 expression (CPS ≥20 vs. 1≤ CPS \<20 vs. CPS \<1) and HPV status (oropharynx HPV positive vs oropharynx HPV negative/unknown and non-oropharynx).|Stratified Cox proportional hazard model|||The hazard ratio and corresponding 2-sided 95% confidence interval was calculated from the cox regression model with Efron's method of tie handling with treatment as a covariate and stratified by PD-L1 expression (CPS ≥20 vs. 1≤ CPS \<20 vs. CPS \<1) and HPV status (positive vs. negative). Participants with oropharynx HPV negative/unknown and non-oropharyngeal tumors were combined as the HPV negative group.||1.71|0.42|0.329
72575795|NCT04428333|144677613|SUPERIORITY|Other|Hazard Ratio (HR)|0.82||||0.302|TWO_SIDED|95.0|0.4|1.69||Nominal p-value was calculated based on the one sided log-rank test, stratified by stratified by PD-L1 expression (CPS ≥20 vs. 1≤ CPS \<20) and HPV status (oropharynx HPV positive vs oropharynx HPV negative/unknown and non-oropharynx).|Stratified Cox proportional hazard model|||The hazard ratio and corresponding 2-sided 95% confidence interval was calculated from the cox regression model with Efron's method of tie handling with treatment as a covariate and stratified by PD-L1 expression (CPS≥20 vs 1≤CPS\<20) and HPV status (positive vs. negative). Participants with oropharynx HPV negative/unknown and non-oropharyngeal tumors were combined as the HPV negative group.||1.69|0.40|0.302
72409915|NCT00274716|144328245|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.7|STANDARD_ERROR_OF_MEAN|0.4|<|0.001|TWO_SIDED|95.0|-2.4|-1.0|||ANCOVA|Treatment group and ambulatory blood pressure measurement (ABPM; yes or no) as class variables and baseline weight as a continuous variable||||-1.0|-2.4|<0.001
72409916|NCT00274716|144328245|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3|STANDARD_ERROR_OF_MEAN|0.4||0.462|TWO_SIDED|95.0|-0.5|1.0|||ANCOVA|Treatment group and ambulatory blood pressure measurement (ABPM; yes or no) as class variables and baseline weight as a continuous variable||||1.0|-0.5|0.462
72541290|NCT05166421|144612358|OTHER||Geometric mean ratio|0.938|||||TWO_SIDED|90.0|0.8458|1.0403||||||Statistical Comparison of AUCinf of AZD7442||1.0403|0.8458|
72541291|NCT05166421|144612358|OTHER||Geometric mean ratio|0.9968|||||TWO_SIDED|90.0|0.898|1.1066||||||Statistical Comparison of AUCinf of AZD7442||1.1066|0.8980|
72541292|NCT05166421|144612358|OTHER||Geometric mean ratio|1.0627|||||TWO_SIDED|90.0|0.9579|1.179||||||Statistical Comparison of AUCinf of AZD7442||1.1790|0.9579|
72541293|NCT05166421|144612358|OTHER||Geometric mean ratio|0.8992|||||TWO_SIDED|90.0|0.8107|0.9974||||||Statistical Comparison of AUCinf of AZD8895||0.9974|0.8107|
72541294|NCT05166421|144612358|OTHER||Geometric mean ratio|0.9826|||||TWO_SIDED|90.0|0.8854|1.0905||||||Statistical Comparison of AUCinf of AZD8895||1.0905|0.8854|
72541295|NCT05166421|144612358|OTHER||Geometric mean ratio|1.0928|||||TWO_SIDED|90.0|0.9853|1.212||||||Statistical Comparison of AUCinf of AZD8895||1.2120|0.9853|
72541296|NCT05166421|144612358|OTHER||Geometric mean ratio|1.0039|||||TWO_SIDED|90.0|0.9029|1.1161||||||Statistical Comparison of AUCinf of AZD1061||1.1161|0.9029|
72541297|NCT05166421|144612358|OTHER||Geometric mean ratio|1.0336|||||TWO_SIDED|90.0|0.9288|1.1503||||||Statistical Comparison of AUCinf of AZD1061||1.1503|0.9288|
72541298|NCT05166421|144612358|OTHER||Geometric mean ratio|1.0296|||||TWO_SIDED|90.0|0.9258|1.1451||||||Statistical Comparison of AUCinf of AZD1061||1.1451|0.9258|
72541299|NCT05166421|144612359|OTHER||Geometric mean ratio|0.9418|||||TWO_SIDED|90.0|0.8512|1.0421||||||Statistical Comparison of AUClast of AZD7442||1.0421|0.8512|
72541300|NCT05166421|144612359|OTHER||Geometric mean ratio|0.9973|||||TWO_SIDED|90.0|0.9004|1.1046||||||Statistical Comparison of AUClast of AZD7442||1.1046|0.9004|
72541301|NCT05166421|144612359|OTHER||Geometric mean ratio|1.0589|||||TWO_SIDED|90.0|0.9559|1.173||||||Statistical Comparison of AUClast of AZD7442||1.1730|0.9559|
72541302|NCT05166421|144612359|OTHER||Geometric mean ratio|0.8812|||||TWO_SIDED|90.0|0.7933|0.9788||||||Statistical Comparison of AUClast of AZD8895||0.9788|0.7933|
72541303|NCT05166421|144612359|OTHER||Geometric mean ratio|0.96|||||TWO_SIDED|90.0|0.8633|1.0674||||||Statistical Comparison of AUClast of AZD8895||1.0674|0.8633|
72409917|NCT00274716|144328245|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.6|STANDARD_ERROR_OF_MEAN|0.4||0.118|TWO_SIDED|95.0|-0.2|1.3|||ANCOVA|Treatment group and ambulatory blood pressure measurement (ABPM; yes or no) as class variables and baseline weight as a continuous variable||||1.3|-0.2|0.118
72409918|NCT00274716|144328246|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.8|STANDARD_ERROR_OF_MEAN|0.9||0.059|TWO_SIDED|95.0|-3.7|0.1|||ANCOVA|Treatment group and ambulatory blood pressure measurement (ABPM; yes or no) as class variables and baseline waist as a continuous variable||||0.1|-3.7|0.059
72409919|NCT00274716|144328246|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.6|STANDARD_ERROR_OF_MEAN|1.0|<|0.001|TWO_SIDED|95.0|-5.5|-1.7|||ANCOVA|Treatment group and ambulatory blood pressure measurement (ABPM; yes or no) as class variables and baseline waist as a continuous variable||||-1.7|-5.5|<0.001
72541304|NCT05166421|144612359|OTHER||Geometric mean ratio|1.0894|||||TWO_SIDED|90.0|0.9796|1.2116||||||Statistical Comparison of AUClast of AZD8895||1.2116|0.9796|
72541305|NCT05166421|144612359|OTHER||Geometric mean ratio|1.0065|||||TWO_SIDED|90.0|0.9061|1.118||||||Statistical Comparison of AUClast of AZD1061||1.1180|0.9061|
72541306|NCT05166421|144612359|OTHER||Geometric mean ratio|1.0293|||||TWO_SIDED|90.0|0.9257|1.1446||||||Statistical Comparison of AUClast of AZD1061||1.1446|0.9257|
72541307|NCT05166421|144612359|OTHER||Geometric mean ratio|1.0227|||||TWO_SIDED|90.0|0.9196|1.1373||||||Statistical Comparison of AUClast of AZD1061||1.1373|0.9196|
72541308|NCT05166421|144612360|OTHER||Geometric mean ratio|1.0308|||||TWO_SIDED|90.0|0.9451|1.1243||||||Statistical Comparison of Cmax of AZD7442||1.1243|0.9451|
72541309|NCT05166421|144612360|OTHER||Geometric mean ratio|0.993|||||TWO_SIDED|90.0|0.9112|1.0822||||||Statistical Comparison of Cmax of AZD7442||1.0822|0.9112|
72541310|NCT05166421|144612360|OTHER||Geometric mean ratio|0.9634|||||TWO_SIDED|90.0|0.8833|1.0507||||||Statistical Comparison of Cmax of AZD7442||1.0507|0.8833|
72541311|NCT05166421|144612360|OTHER||Geometric mean ratio|0.9701|||||TWO_SIDED|90.0|0.8894|1.0582||||||Statistical Comparison of Cmax of AZD8895||1.0582|0.8894|
72541312|NCT05166421|144612360|OTHER||Geometric mean ratio|0.9629|||||TWO_SIDED|90.0|0.8835|1.0494||||||Statistical Comparison of Cmax of AZD8895||1.0494|0.8835|
72541313|NCT05166421|144612360|OTHER||Geometric mean ratio|0.9926|||||TWO_SIDED|90.0|0.91|1.0826||||||Statistical Comparison of Cmax of AZD8895||1.0826|0.9100|
72541314|NCT05166421|144612360|OTHER||Geometric mean ratio|1.0976|||||TWO_SIDED|90.0|0.9992|1.2057||||||Statistical Comparison of Cmax of AZD1061||1.2057|0.9992|
72541315|NCT05166421|144612360|OTHER||Geometric mean ratio|1.0195|||||TWO_SIDED|90.0|0.929|1.119||||||Statistical Comparison of Cmax of AZD1061||1.1190|0.9290|
72541316|NCT05166421|144612360|OTHER||Geometric mean ratio|0.9289|||||TWO_SIDED|90.0|0.8457|1.0203||||||Statistical Comparison of Cmax of AZD1061||1.0203|0.8457|
72541317|NCT03958071|144612372|OTHER||Absolute standardized differences (ASD)|-0.1027||||0.281|||||||t-test, 2 sided||ASD=(X1-X2)/sqrt((s1\^2+s2\^2)/2). Where X denotes sample means in each cohort, and s denotes sample variances.|||||0.2810
72541318|NCT03958071|144612372|OTHER||Absolute standardized differences (ASD)|-0.078||||0.1421|||||||t-test, 2 sided||ASD=(X1-X2)/sqrt((s1\^2+s2\^2)/2). Where X denotes sample means in each cohort, and s denotes sample variances.|||||0.1421
72541319|NCT03958071|144612372|OTHER||Absolute standardized differences (ASD)|0.0159||||0.0048|||||||t-test, 2 sided||ASD=(X1-X2)/sqrt((s1\^2+s2\^2)/2). Where X denotes sample means in each cohort, and s denotes sample variances.|||||0.0048
72541320|NCT03958071|144612374|OTHER||Absolute standardized differences (ASD)|0.0214||||0.7681|||||||Chi-squared||ASD=(p1-p2)/(sqrt(p1\^(1-p1)+p2(1-p2))/2). Where p denotes proportion of a binary variable in each cohort.|||||0.7681
72541321|NCT03958071|144612374|OTHER||Absolute standardized differences (ASD)|0.371|||<|0.0001|||||||Chi-squared||ASD=(p1-p2)/(sqrt(p1\^(1-p1)+p2(1-p2))/2). Where p denotes proportion of a binary variable in each cohort.|||||<.0001
72541322|NCT03958071|144612374|OTHER||Absolute standardized differences (ASD)|0.349|||<|0.0001|||||||Chi-squared||ASD=(p1-p2)/(sqrt(p1\^(1-p1)+p2(1-p2))/2). Where p denotes proportion of a binary variable in each cohort.|||||<.0001
72541323|NCT03958071|144612375|OTHER||Absolute standardized differences (ASD)|-0.1257||||0.1659|||||||t-test, 2 sided||ASD=(X1-X2)/sqrt((s1\^2+s2\^2)/2). Where X denotes sample means in each cohort, and s denotes sample variances.|||||0.1659
72409920|NCT00274716|144328246|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.4|STANDARD_ERROR_OF_MEAN|0.9||0.136|TWO_SIDED|95.0|-3.3|0.5|||ANCOVA|Treatment group and ambulatory blood pressure measurement (ABPM; yes or no) as class variables and baseline waist as a continuous variable||||0.5|-3.3|0.136
72541324|NCT03958071|144612375|OTHER||Absolute standardized differences (ASD)|0.1566||||0.0112|||||||t-test, 2 sided||ASD=(X1-X2)/sqrt((s1\^2+s2\^2)/2). Where X denotes sample means in each cohort, and s denotes sample variances.|||||0.0112
72541325|NCT03958071|144612375|OTHER||Absolute standardized differences (ASD)|0.3019|||<|0.0001|||||||t-test, 2 sided||ASD=(X1-X2)/sqrt((s1\^2+s2\^2)/2). Where X denotes sample means in each cohort, and s denotes sample variances.|||||<.0001
72541326|NCT03958071|144612376|OTHER||Absolute standardized differences (ASD)|-0.0209||||0.326|||||||t-test, 2 sided||ASD=(X1-X2)/sqrt((s1\^2+s2\^2)/2). Where X denotes sample means in each cohort, and s denotes sample variances.|||||0.3260
72541327|NCT03958071|144612376|OTHER||Absolute standardized differences (ASD)|-0.2694|||<|0.0001|||||||t-test, 2 sided||ASD=(X1-X2)/sqrt((s1\^2+s2\^2)/2). Where X denotes sample means in each cohort, and s denotes sample variances.|||||<.0001
72541328|NCT03958071|144612376|OTHER||Absolute standardized differences (ASD)|-0.2352|||<|0.0001|||||||t-test, 2 sided||ASD=(X1-X2)/sqrt((s1\^2+s2\^2)/2). Where X denotes sample means in each cohort, and s denotes sample variances.|||||<.0001
72541329|NCT03958071|144612377|OTHER||Absolute standardized differences (ASD)|0.09||||0.2042|||||||Chi-squared||ASD=(p1-p2)/(sqrt(p1\^(1-p1)+p2(1-p2))/2). Where p denotes proportion of a binary variable in each cohort.|||||0.2042
72541330|NCT03958071|144612377|OTHER||Absolute standardized differences (ASD)|0.21|||<|0.0001|||||||Chi-squared||ASD=(p1-p2)/(sqrt(p1\^(1-p1)+p2(1-p2))/2). Where p denotes proportion of a binary variable in each cohort.|||||<.0001
72541331|NCT03958071|144612377|OTHER||Absolute standardized differences (ASD)|0.11||||0.02|||||||Chi-squared||ASD=(p1-p2)/(sqrt(p1\^(1-p1)+p2(1-p2))/2). Where p denotes proportion of a binary variable in each cohort.|||||0.02
72541332|NCT03958071|144612378|OTHER||Absolute standardized differences (ASD)|0.0241||||0.7395|||||||Chi-squared||ASD=(p1-p2)/(sqrt(p1\^(1-p1)+p2(1-p2))/2). Where p denotes proportion of a binary variable in each cohort.|||||0.7395
72541333|NCT03958071|144612378|OTHER||Absolute standardized differences (ASD)|0.1644||||0.0017|||||||Chi-squared||ASD=(p1-p2)/(sqrt(p1\^(1-p1)+p2(1-p2))/2). Where p denotes proportion of a binary variable in each cohort.|||||0.0017
72541334|NCT03958071|144612378|OTHER||Absolute standardized differences (ASD)|0.1403||||0.0034|||||||Chi-squared||ASD=(p1-p2)/(sqrt(p1\^(1-p1)+p2(1-p2))/2). Where p denotes proportion of a binary variable in each cohort.|||||0.0034
72541335|NCT02595528|144612422|SUPERIORITY||Least Squares (LS)|-2.5543||||0.0029|||||||Mixed model for repeated measures|||AGN-190584 Quadratic||||0.0029
72541336|NCT02595528|144612422|SUPERIORITY||Least Squares (LS)|6.6961|||<|0.0001|||||||Mixed model for repeated measures|||AGN-190584 Linear||||<0.0001
72541337|NCT02595528|144612422|SUPERIORITY||Least Squares (LS)|-69.89||||0.4126|||||||Mixed model for repeated measures|||AGN-199201 Quadratic||||0.4126
72541338|NCT02595528|144612422|SUPERIORITY||Least Squares (LS)|10.5017||||0.3752|||||||Mixed model for repeated measures|||AGN-199201 Linear||||0.3752
72409921|NCT00274716|144328246|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.9||0.686|TWO_SIDED|95.0|-2.2|1.4|||ANCOVA|Treatment group and ambulatory blood pressure measurement (ABPM; yes or no) as class variables and baseline waist as a continuous variable||||1.4|-2.2|0.686
72541339|NCT02292433|144612449|SUPERIORITY_OR_OTHER||LS Mean Difference|-19.96|STANDARD_ERROR_OF_MEAN|4.841||0.0032|TWO_SIDED|90.0|-28.93|-10.98|||Mixed Models Analysis|||Analysis was done using a mixed effect model with sequence, period, dose, and baseline as fixed effects and participants within sequence as a random effect.||-10.98|-28.93|0.0032
72541340|NCT02292433|144612449|SUPERIORITY_OR_OTHER||LS Mean Difference|-41.06|STANDARD_ERROR_OF_MEAN|3.172|<|0.0001|TWO_SIDED|90.0|-46.77|-35.35|||Mixed Models Analysis|||Analysis was done using a mixed effect model with sequence, period, dose, and baseline as fixed effects and participants within sequence as a random effect.||-35.35|-46.77|<0.0001
72541341|NCT02292433|144612450|SUPERIORITY_OR_OTHER||LS Mean Difference|-12.18|STANDARD_ERROR_OF_MEAN|2.851||0.0006|TWO_SIDED|90.0|-17.16|-7.21|||Mixed Models Analysis|||Analysis was done using a mixed effect model with sequence, period, dose, and baseline as fixed effects and participants within sequence as a random effect.||-7.21|-17.16|0.0006
72541342|NCT02292433|144612450|SUPERIORITY_OR_OTHER||LS Mean Difference|-25.81|STANDARD_ERROR_OF_MEAN|2.821|<|0.0001|TWO_SIDED|90.0|-30.73|-20.88|||Mixed Models Analysis|||Analysis was done using a mixed effect model with sequence, period, dose, and baseline as fixed effects and participants within sequence as a random effect.||-20.88|-30.73|<0.0001
72541343|NCT02292433|144612451|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.521|STANDARD_ERROR_OF_MEAN|0.7237||0.0447|TWO_SIDED|90.0|-2.752|-0.29|||Mixed Models Analysis|||Analysis for pre-breakfast. Analysis was done using a mixed effect model with sequence, period, dose, and baseline as fixed effects and participants within sequence as a random effect.||-0.290|-2.752|0.0447
72541344|NCT02292433|144612451|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.949|STANDARD_ERROR_OF_MEAN|0.7249||0.0119|TWO_SIDED|90.0|-3.183|-0.716|||Mixed Models Analysis|||Analysis for pre-breakfast. Analysis was done using a mixed effect model with sequence, period, dose, and baseline as fixed effects and participants within sequence as a random effect.||-0.716|-3.183|0.0119
72541345|NCT02292433|144612451|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.967|STANDARD_ERROR_OF_MEAN|2.3324||0.6873|TWO_SIDED|90.0|-5.195|3.261|||Mixed Models Analysis|||Analysis for pre-lunch. Analysis was done using a mixed effect model with sequence, period, dose, and baseline as fixed effects and participants within sequence as a random effect.||3.261|-5.195|0.6873
72541346|NCT02292433|144612451|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.439|STANDARD_ERROR_OF_MEAN|0.9533||0.0659|TWO_SIDED|90.0|-4.502|-0.377|||Mixed Models Analysis|||Analysis for pre-lunch. Analysis was done using a mixed effect model with sequence, period, dose, and baseline as fixed effects and participants within sequence as a random effect.||-0.377|-4.502|0.0659
72541347|NCT02292433|144612451|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.358|STANDARD_ERROR_OF_MEAN|1.5994||0.4031|TWO_SIDED|90.0|-4.079|1.363|||Mixed Models Analysis|||Analysis for pre-dinner. Analysis was done using a mixed effect model with sequence, period, dose, and baseline as fixed effects and participants within sequence as a random effect.||1.363|-4.079|0.4031
72541348|NCT02292433|144612451|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.766|STANDARD_ERROR_OF_MEAN|1.5951||0.0254|TWO_SIDED|90.0|-6.479|-1.052|||Mixed Models Analysis|||Analysis for pre-dinner. Analysis was done using a mixed effect model with sequence, period, dose, and baseline as fixed effects and participants within sequence as a random effect.||-1.052|-6.479|0.0254
72409922|NCT00274716|144328246|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.2|STANDARD_ERROR_OF_MEAN|0.9||0.022|TWO_SIDED|95.0|-4.0|-0.3|||ANCOVA|Treatment group and ambulatory blood pressure measurement (ABPM; yes or no) as class variables and baseline waist as a continuous variable||||-0.3|-4.0|0.022
72409923|NCT00274716|144328247|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.3|STANDARD_ERROR_OF_MEAN|4.3||0.005|TWO_SIDED|95.0|-20.8|-3.7|||ANCOVA|Treatment group and ambulatory blood pressure measurement (ABPM; yes or no) as class variables and baseline LDL-C as a continuous variable||||-3.7|-20.8|0.005
72541349|NCT02292433|144612452|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.21|STANDARD_ERROR_OF_MEAN|0.069||0.0067|TWO_SIDED|90.0|-0.33|-0.09|||Mixed Models Analysis|||Analysis for pre-breakfast. Analysis was done using a mixed effect model with sequence, period, dose, and baseline as fixed effects and participants within sequence as a random effect.||-0.09|-0.33|0.0067
72541350|NCT02292433|144612452|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.071||0.0282|TWO_SIDED|90.0|-0.29|-0.05|||Mixed Models Analysis|||Analysis for pre-breakfast. Analysis was done using a mixed effect model with sequence, period, dose, and baseline as fixed effects and participants within sequence as a random effect.||-0.05|-0.29|0.0282
72541351|NCT02292433|144612452|SUPERIORITY_OR_OTHER||LS Mean Difference|0.03|STANDARD_ERROR_OF_MEAN|0.118||0.7877|TWO_SIDED|90.0|-0.18|0.25|||Mixed Models Analysis|||Analysis for pre-lunch. Analysis was done using a mixed effect model with sequence, period, dose, and baseline as fixed effects and participants within sequence as a random effect.||0.25|-0.18|0.7877
72541352|NCT02292433|144612452|SUPERIORITY_OR_OTHER||LS Mean Difference|0.11|STANDARD_ERROR_OF_MEAN|0.156||0.5064|TWO_SIDED|90.0|-0.17|0.39|||Mixed Models Analysis|||Analysis for pre-lunch. Analysis was done using a mixed effect model with sequence, period, dose, and baseline as fixed effects and participants within sequence as a random effect.||0.39|-0.17|0.5064
72541353|NCT02292433|144612452|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.25|STANDARD_ERROR_OF_MEAN|0.293||0.4072|TWO_SIDED|90.0|-0.75|0.25|||Mixed Models Analysis|||Analysis for pre-dinner. Analysis was done using a mixed effect model with sequence, period, dose, and baseline as fixed effects and participants within sequence as a random effect.||0.25|-0.75|0.4072
72541354|NCT02292433|144612452|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.45|STANDARD_ERROR_OF_MEAN|0.295||0.1422|TWO_SIDED|90.0|-0.95|0.06|||Mixed Models Analysis|||Analysis for pre-dinner. Analysis was done using a mixed effect model with sequence, period, dose, and baseline as fixed effects and participants within sequence as a random effect.||0.06|-0.95|0.1422
72541355|NCT03101293|144612453|EQUIVALENCE|A linear mixed effect model on the natural log-transformed parameters was performed with regimen, sequence and period as fixed effects and participant nested within sequence as a random effect. The least squares means and difference of least squares means for the log-transformed parameters were exponentiated to obtain the point estimates of the food effect and 90% confidence intervals (CIs).|LS Mean Ratio|1.343||||0.0058|TWO_SIDED|90.0|1.146|1.574|||ANOVA|||||1.574|1.146|0.0058
72541356|NCT03101293|144612454|EQUIVALENCE|A linear mixed effect model on the natural log-transformed parameters was performed with regimen, sequence and period as fixed effects and participant nested within sequence as a random effect. The least squares means and difference of least squares means for the log-transformed parameters were exponentiated to obtain the point estimates of the food effect and 90% CIs.|LS Mean Ratio|1.121||||0.1763|TWO_SIDED|90.0|0.969|1.298|||ANOVA|||||1.298|0.969|0.1763
72541357|NCT03101293|144612455|EQUIVALENCE|A linear mixed effect model on the natural log-transformed parameters was performed with regimen, sequence and period as fixed effects and participant nested within sequence as a random effect. The least squares means and difference of least squares means for the log-transformed parameters were exponentiated to obtain the point estimates of the food effect and 90% CIs.|LS Mean Ratio|1.154||||0.2745|TWO_SIDED|90.0|0.929|1.433|||ANOVA|||||1.433|0.929|0.2745
72541358|NCT04378010|144612497|OTHER||LS mean difference|1.88|STANDARD_ERROR_OF_MEAN|1.788||0.454|TWO_SIDED|95.0|-3.479|7.239|||Mixed model repeated measures|||||7.239|-3.479|0.454
72541359|NCT04378010|144612497|OTHER||LS mean difference|-0.439|STANDARD_ERROR_OF_MEAN|1.553||0.848|TWO_SIDED|95.0|-5.458|4.579|||Mixed model repeated measures|||||4.579|-5.458|0.848
72541360|NCT04378010|144612508|OTHER||LS mean difference|-11.718|STANDARD_ERROR_OF_MEAN|7.052||0.114|TWO_SIDED|95.0|-26.342|2.906|||ANCOVA|||||2.906|-26.342|0.114
72541361|NCT04378010|144612508|OTHER||LS mean difference|-11.261|STANDARD_ERROR_OF_MEAN|6.879||0.099|TWO_SIDED|95.0|-24.723|2.2|||ANCOVA|||||2.200|-24.723|0.099
72541362|NCT04378010|144612509|OTHER||LS mean difference|1.05|STANDARD_ERROR_OF_MEAN|0.331||0.003|TWO_SIDED|95.0|0.365|1.736|||ANCOVA|||||1.736|0.365|0.003
72541363|NCT04378010|144612509|OTHER||LS mean difference|0.591|STANDARD_ERROR_OF_MEAN|0.315||0.064|TWO_SIDED|95.0|-0.035|1.216|||ANCOVA|||||1.216|-0.035|0.064
72541364|NCT04378010|144612513|OTHER||LS mean difference|12.986|STANDARD_ERROR_OF_MEAN|5.472||0.04|TWO_SIDED|95.0|0.608|25.363|||Mixed model repeated measures|||||25.363|0.608|0.040
72541365|NCT04378010|144612513|OTHER||LS mean difference|7.211|STANDARD_ERROR_OF_MEAN|5.724||0.242|TWO_SIDED|95.0|-4.997|19.418|||Mixed model repeated measures|||||19.418|-4.997|0.242
72541366|NCT03137082|144612562|SUPERIORITY||||||<|0.03|||||||Mixed Models Analysis|||||||<0.03
72541367|NCT03137082|144612563|SUPERIORITY|||||||0.1|||||||Mixed Models Analysis|||||||0.1
72541368|NCT03137082|144612565|SUPERIORITY|||||||0.01|||||||Mixed Models Analysis|||||||0.01
72541369|NCT03137082|144612566|SUPERIORITY|||||||0.001|||||||Mixed Models Analysis|||||||0.001
72541370|NCT03137082|144612567|SUPERIORITY|||||||0.5|||||||Mixed Models Analysis|||||||0.5
72541371|NCT03137082|144612568|SUPERIORITY||||||<|0.03|||||||Mixed Models Analysis|||||||<.03
72541372|NCT03137082|144612569|SUPERIORITY|||||||0.1|||||||Mixed Models Analysis|||||||0.1
72541373|NCT03137082|144612570|SUPERIORITY||||||<|0.3|||||||Mixed Models Analysis|||||||<0.3
72541374|NCT03137082|144612571|SUPERIORITY|||||||0.04|||||||Mixed Models Analysis|||||||0.04
72541375|NCT03137082|144612572|SUPERIORITY|||||||0.4|||||||Mixed Models Analysis|||||||0.4
72575796|NCT04428333|144677614|SUPERIORITY|Other|Hazard Ratio (HR)|0.96||||0.472|TWO_SIDED|95.0|0.44|2.11||Nominal p-value was calculated based on the one sided log-rank test, stratified by stratified by PD-L1 expression (CPS ≥20 vs. 1≤ CPS \<20 vs. CPS \<1) and HPV status (oropharynx HPV positive vs oropharynx HPV negative/unknown and non-oropharynx).|Stratified Cox proportional hazard model|||The hazard ratio and corresponding 2-sided 95% confidence interval was calculated from the cox regression model with Efron's method of tie handling with treatment as a covariate and stratified by PD-L1 expression (CPS ≥20 vs. 1≤ CPS \<20 vs. CPS \<1) and HPV status (positive vs. negative). Participants with oropharynx HPV negative/unknown and non-oropharyngeal tumors were combined as the HPV negative group.||2.11|0.44|0.472
72575797|NCT04428333|144677615|SUPERIORITY|Other|Hazard Ratio (HR)|0.83||||0.335|TWO_SIDED|95.0|0.36|1.9||Nominal p-value was calculated based on the one sided log-rank test, stratified by stratified by PD-L1 expression (CPS ≥20 vs. 1≤ CPS \<20) and HPV status (oropharynx HPV positive vs oropharynx HPV negative/unknown and non-oropharynx).|Stratified Cox proportional hazard model|||The hazard ratio and corresponding 2-sided 95% confidence interval was calculated from the cox regression model with Efron's method of tie handling with treatment as a covariate and stratified by PD-L1 expression (CPS≥20 vs 1≤CPS\<20) and HPV status (positive vs. negative). Participants with oropharynx HPV negative/unknown and non-oropharyngeal tumors were combined as the HPV negative group.||1.90|0.36|0.335
72575798|NCT04853992|144677619|SUPERIORITY||Mean Difference (Net)|-0.58|STANDARD_ERROR_OF_MEAN|0.5||0.277|TWO_SIDED|95.0|-1.69|0.53|||Mixed Models Analysis|||The primary endpoint, change from baseline in post-provocation Urticaria Activity Score (UASprovo) to the end of the treatment period, was compared between treatments with the null hypothesis that they are equal against the alternative that they are different. The primary efficacy endpoint was analysed using a linear mixed model, containing treatment, period and carryover effects, the factor site and additionally the value of UASprovo at baseline as a covariate.||0.53|-1.69|0.277
72575799|NCT03582826|144677624|SUPERIORITY|Paired Wilcoxon Signed-Rank Tests|Median Difference (Final Values)|79.0||||0.02|TWO_SIDED|95.0|26.0|163.0||Original p-value for dermatological bacteria was 6e-05. It was adjusted first by applying centered log-ratio (CLR) transformation approach then by false discovery rate (FDR) correction for multiple comparisons by using Benjamini-Hochberg Procedure.|Wilcoxon (Mann-Whitney)|||||163|26|0.02
72575800|NCT00319982|144677635|SUPERIORITY_OR_OTHER|||||||0.75|TWO_SIDED|||||Adjusted for age, sex, genotype, family relations, and baseline value. p\<0.05 considered statistically significant.|Generalized estimating equation|Generalized estimating equation approach accounting for an exchangeable correlation structure within families||Change in E' Velocity comparing baseline and final study visits||||0.75
72575801|NCT00319982|144677636|SUPERIORITY_OR_OTHER|||||||0.99|TWO_SIDED||||||Fisher Exact|||Adverse Events||||0.99
72575802|NCT00319982|144677637|SUPERIORITY_OR_OTHER||||||>|0.06|TWO_SIDED|||||Adjusted for age, sex, genotype, family relations, and baseline value. p\<0.05 considered statistically significant.|Generalized Estimating Equation|Generalized estimating equation approach accounting for an exchangeable correlation structure within families||||||>0.06
72541376|NCT03137082|144612573|SUPERIORITY|||||||0.08|||||||Mixed Models Analysis|||||||0.08
72541377|NCT03137082|144612574|SUPERIORITY|||||||0.2|||||||Mixed Models Analysis|||||||0.2
72541378|NCT03547531|144612627|OTHER||||||>|0.05|||||||t-test, 2 sided|independent t-test||Null hypothesis: the mean of plaque index between groups are not different|the statistical analysis used in this study is independent t-test|||>0.05
72541379|NCT03547531|144612628|OTHER|this data is analyzed using independent t-test|||||>|0.05|||||||t-test, 2 sided|||null hypotesis: there is no difference of mean of gingival index between groups|this data is analyzed using independent t-test|||>0.05
72541380|NCT03547531|144612629|OTHER|this data is analyzed using independent t-test|||||<|0.05|||||||t-test, 2 sided|||null hypotesis: there is no difference of mean of plaque index between groups|this data is analyzed using independent t-test|||<0.05
72541381|NCT03547531|144612630|OTHER|this data is analyzed using independent t-test|||||<|0.05|||||||t-test, 2 sided|||null hypotesis: there is no difference of mean of gingival index between groups|this data is analyzed using independent t-test|||<0.05
72541382|NCT02444182|144612637|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.28|STANDARD_DEVIATION|0.21||0.015|TWO_SIDED||||||paired t-test|||Null hypothesis was no difference in Gingival index between probiotics and control groups||||0.015
72541383|NCT02444182|144612638|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.09|STANDARD_DEVIATION|0.09||0.909|TWO_SIDED||||||paired t-test|||Null hypothesis was no difference in plaque index between probiotics and control groups||||0.909
72541384|NCT02981602|144612670|OTHER|||||||0.116||||||Baseline was the covariate and treatment group as a factor for the comparison between GSK3228836 and placebo group|ANCOVA|||||||0.116
72541385|NCT02981602|144612670|OTHER||||||<|0.001||||||Baseline was the covariate and treatment group as a factor for the comparison between GSK3228836 and placebo group|ANCOVA|||||||<0.001
72541386|NCT02981602|144612670|OTHER|||||||0.573||||||Baseline was the covariate and treatment group as a factor for the comparison between GSK3228836 and placebo group|ANCOVA|||||||0.573
72541387|NCT02981602|144612671|OTHER|||||||0.609||||||Baseline was the covariate and treatment group as a factor for the comparison between GSK3228836 and placebo group|ANCOVA|||||||0.609
72541388|NCT02981602|144612671|OTHER|||||||0.141||||||Baseline was the covariate and treatment group as a factor for the comparison between GSK3228836 and placebo group|ANCOVA|||||||0.141
72541389|NCT02981602|144612672|OTHER|Baseline was the covariate and treatment group as a factor for the comparison between GSK3228836 and placebo group||||||0.245|||||||ANCOVA|||||||0.245
72541390|NCT02981602|144612672|OTHER|||||||0.001||||||Baseline was the covariate and treatment group as a factor for the comparison between GSK3228836 and placebo group|ANCOVA|||||||0.001
72627733|NCT00565409|144783952|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.33||||0.213|TWO_SIDED|95.0|-6.0|1.3||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 88||1.3|-6.0|0.2130
72627734|NCT00565409|144783952|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.83|||<|0.0001|TWO_SIDED|95.0|-14.5|-7.1||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 88||-7.1|-14.5|<0.0001
72627735|NCT00565409|144783955|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.55|||<|0.0001|TWO_SIDED|95.0|-11.8|-5.3||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 40||-5.3|-11.8|<0.0001
72541391|NCT02981602|144612672|OTHER|||||||0.762||||||Baseline was the covariate and treatment group as a factor for the comparison between GSK3228836 and placebo group|ANCOVA|||||||0.762
72627736|NCT00565409|144783955|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4||||0.8033|TWO_SIDED|95.0|-3.6|2.8||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 40||2.8|-3.6|0.8033
72627737|NCT00565409|144783955|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.14|||<|0.0001|TWO_SIDED|95.0|-11.3|-4.9||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 40||-4.9|-11.3|<0.0001
72627738|NCT00565409|144783955|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.61|||<|0.0001|TWO_SIDED|95.0|-17.2|-10.0||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 48||-10.0|-17.2|<0.0001
72627739|NCT00565409|144783955|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5||||0.783|TWO_SIDED|95.0|-4.1|3.1||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 48||3.1|-4.1|0.7830
72541392|NCT02981602|144612673|OTHER|||||||0.141||||||Baseline was the covariate and treatment group as a factor for the comparison between GSK3228836 and placebo group|ANCOVA|||||||0.141
72627740|NCT00565409|144783955|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.11|||<|0.0001|TWO_SIDED|95.0|-16.7|-9.5||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 48||-9.5|-16.7|<0.0001
72627741|NCT00565409|144783955|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.53|||<|0.0001|TWO_SIDED|95.0|-16.1|-8.9||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 56||-8.9|-16.1|<0.0001
72627742|NCT00565409|144783955|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.02||||0.5732|TWO_SIDED|95.0|-4.6|2.5||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization|ANCOVA|||Week 56||2.5|-4.6|0.5732
72627743|NCT00565409|144783955|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.5|||<|0.0001|TWO_SIDED|95.0|-15.1|-7.9||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 56||-7.9|-15.1|<0.0001
72627744|NCT00565409|144783955|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.88|||<|0.0001|TWO_SIDED|95.0|-17.6|-10.2||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 64||-10.2|-17.6|<0.0001
72627745|NCT00565409|144783955|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.94||||0.2972|TWO_SIDED|95.0|-5.6|1.7||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 64||1.7|-5.6|0.2972
72541393|NCT02981602|144612673|OTHER|||||||0.081||||||Baseline was the covariate and treatment group as a factor for the comparison between GSK3228836 and placebo group|ANCOVA|||||||0.081
72541394|NCT02981602|144612673|OTHER|||||||0.616||||||Baseline was the covariate and treatment group as a factor for the comparison between GSK3228836 and placebo group|ANCOVA|||||||0.616
72541395|NCT02981602|144612676|OTHER|||||||0.763||||||Baseline was the covariate and treatment group as a factor for the comparison between GSK3228836 and placebo group|ANCOVA|||||||0.763
72541396|NCT02981602|144612676|OTHER|||||||0.804||||||Baseline was the covariate and treatment group as a factor for the comparison between GSK3228836 and placebo group|ANCOVA|||||||0.804
72541397|NCT02981602|144612677|OTHER|||||||0.372||||||Baseline was the covariate and treatment group as a factor for the comparison between GSK3228836 and placebo group|ANCOVA|||||||0.372
72541398|NCT02981602|144612677|OTHER|||||||0.954||||||Baseline was the covariate and treatment group as a factor for the comparison between GSK3228836 and placebo group|ANCOVA|||||||0.954
72541399|NCT00386100|144612690|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.49|||<|0.0001|TWO_SIDED|95.0|-0.669|-0.305||No adjustment for multiple comparisons|ANCOVA|ANCOVA with terms for treatment, region, gender, and baseline value with LOCF from Week 32 for withdrawn participants or missing values|AVM mean change from baseline minus MET mean change from baseline based on ANCOVA model|||-0.305|-0.669|<0.0001
72627746|NCT00565409|144783955|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.94|||<|0.0001|TWO_SIDED|95.0|-15.6|-8.3||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 64||-8.3|-15.6|<0.0001
72627747|NCT00565409|144783955|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.64|||<|0.0001|TWO_SIDED|95.0|-19.4|-11.8||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 72||-11.8|-19.4|<0.0001
72627748|NCT00565409|144783955|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.8||||0.1477|TWO_SIDED|95.0|-6.6|1.0||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 72||1.0|-6.6|0.1477
72575803|NCT00319982|144677638|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Adjusted for age, sex, genotype, family relations, and baseline value|Generalized Estimating Equation|Generalized estimating equation approach accounting for an exchangeable correlation structure within families||Change in LV End-Diastolic Diameter z-score from baseline to final visit||||<0.001
72575804|NCT00319982|144677640|SUPERIORITY_OR_OTHER|||||||0.08|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Percentage adherent to study medication||||0.08
72575805|NCT00319982|144677641|SUPERIORITY_OR_OTHER|||||||0.15|TWO_SIDED|||||Adjusted for age, sex, genotype, family relations, and baseline value|Generalized estimating equation|Generalized estimating equation approach accounting for an exchangeable correlation structure within families||||||0.15
72575806|NCT03480386|144677644|SUPERIORITY|||||||0.0788|||||||t-test, 2 sided|||Daily Light Physical Activity||||0.0788
72575807|NCT03480386|144677644|SUPERIORITY|||||||0.0742|||||||t-test, 2 sided|||Daily Moderate Physical Activity||||0.0742
72575808|NCT03480386|144677645|SUPERIORITY|||||||0.0113|||||||t-test, 2 sided|||||||0.0113
72575809|NCT03480386|144677646|SUPERIORITY|||||||0.0021|||||||t-test, 2 sided|||||||0.0021
72575810|NCT03480386|144677647|SUPERIORITY|||||||0.2216|||||||t-test, 2 sided|||||||0.2216
72575811|NCT03480386|144677648|SUPERIORITY|||||||0.4762|||||||t-test, 2 sided|||||||0.4762
72575812|NCT03480386|144677649|SUPERIORITY|||||||0.0068|||||||t-test, 2 sided|||||||0.0068
72575813|NCT03480386|144677650|SUPERIORITY|||||||0.1548|||||||t-test, 2 sided|||||||0.1548
72575814|NCT00574912|144677652|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
72575815|NCT02629354|144677653|SUPERIORITY_OR_OTHER||Percent Ratio Test/Ref|113.77|||||TWO_SIDED|90.0|98.99|130.75|||ANOVA||Analysis of variance (ANOVA) with fixed effects for sequence, subject nested within sequence, period and product after logarithmic transformation of the data.|Relative bioavailability \[%\] was estimated by the ratios of the geometric means (100\*test/reference \[T/R\]). Additionally, it's two-sided 90% confidence interval (CI) was provided.||130.75|98.99|
72575816|NCT02629354|144677654|SUPERIORITY_OR_OTHER||Percent Ratio Test/Ref|110.16|||||TWO_SIDED|90.0|96.32|125.97|||ANOVA||ANOVA with fixed effects for sequence, subject nested within sequence, period and product after logarithmic transformation of the data.|Relative bioavailability \[%\] was estimated by the ratios of the geometric means (100\*test/reference \[T/R\]). Additionally, it's two-sided 90% CI was provided.||125.97|96.32|
72575817|NCT02629354|144677655|SUPERIORITY_OR_OTHER||Percent Ratio Test/Ref|112.69|||||TWO_SIDED|90.0|98.49|128.94|||ANOVA||ANOVA with fixed effects for sequence, subject nested within sequence, period and product after logarithmic transformation of the data.|Relative bioavailability \[%\] was estimated by the ratios of the geometric means (100\*test/reference \[T/R\]). Additionally, it's two-sided 90% CI was provided.||128.94|98.49|
72575818|NCT02629354|144677656|SUPERIORITY_OR_OTHER||Percent Ratio Test/Ref|97.36|||||TWO_SIDED|90.0|94.61|100.19|||ANOVA||ANOVA with fixed effects for sequence, subject nested within sequence, period and product after logarithmic transformation of the data.|Relative bioavailability \[%\] was estimated by the ratios of the geometric means (100\*test/reference \[T/R\]). Additionally, it's two-sided 90% CI was provided.||100.19|94.61|
72575819|NCT02629354|144677657|SUPERIORITY_OR_OTHER||Percent Ratio Test/Ref|96.47|||||TWO_SIDED|90.0|93.74|99.28|||ANOVA||ANOVA with fixed effects for sequence, subject nested within sequence, period and product after logarithmic transformation of the data.|Relative bioavailability \[%\] was estimated by the ratios of the geometric means (100\*test/reference \[T/R\]). Additionally, it's two-sided 90% CI was provided.||99.28|93.74|
72575820|NCT02629354|144677658|SUPERIORITY_OR_OTHER||Percent Ratio Test/Ref|97.55|||||TWO_SIDED|90.0|92.57|102.8|||ANOVA||ANOVA with fixed effects for sequence, subject nested within sequence, period and product after logarithmic transformation of the data.|Relative bioavailability \[%\] was estimated by the ratios of the geometric means (100\*test/reference \[T/R\]). Additionally, it's two-sided 90% CI was provided.||102.80|92.57|
72575821|NCT02629354|144677659|SUPERIORITY_OR_OTHER||Percent Ratio Test/Ref|97.57|||||TWO_SIDED|90.0|94.5|100.73|||ANOVA||ANOVA with fixed effects for sequence, subject nested within sequence, period and product after logarithmic transformation of the data.|Relative bioavailability \[%\] was estimated by the ratios of the geometric means (100\*test/reference \[T/R\]). Additionally, it's two-sided 90% CI was provided.||100.73|94.50|
72575822|NCT02629354|144677660|SUPERIORITY_OR_OTHER||Percent Ratio Test/Ref|97.21|||||TWO_SIDED|90.0|92.22|102.46|||ANOVA||ANOVA with fixed effects for sequence, subject nested within sequence, period and product after logarithmic transformation of the data.|Relative bioavailability \[%\] was estimated by the ratios of the geometric means (100\*test/reference \[T/R\]). Additionally, it's two-sided 90% CI was provided.||102.46|92.22|
72575823|NCT02629354|144677661|SUPERIORITY_OR_OTHER||Percent Ratio Test/Ref|96.83|||||TWO_SIDED|90.0|93.75|100.01|||ANOVA||ANOVA with fixed effects for sequence, subject nested within sequence, period and product after logarithmic transformation of the data.|Relative bioavailability \[%\] was estimated by the ratios of the geometric means (100\*test/reference \[T/R\]). Additionally, it's two-sided 90% CI was provided.||100.01|93.75|
72575824|NCT00371397|144677662|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.75||||0.009||95.0|||||Regression, Logistic|||hsCRP dichotomized as undetectable/detectable. Logistic regression w/generalized estimating equations(GEE)s to determine odds ratio. Assessed hsCRP at baseline at each of the three visits; 43% of the values (n = 65) were below the assay's detectable lower bound of .3 mg/dL, and thus hsCRP was dichotomized as undetectable/detectable.||||.009
72575825|NCT02105974|144677725|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.034||||0.001|TWO_SIDED|95.0|0.014|0.055|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM)||||0.055|0.014|0.001
72575826|NCT02105974|144677726|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|2.62||||0.084|TWO_SIDED|95.0|-0.35|5.59|||ANCOVA|||||5.59|-0.35|0.084
72575827|NCT02105974|144677727|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.58|||<|0.001|TWO_SIDED|95.0|0.43|0.78||Nominal p-value|Regression, Cox|||||0.78|0.43|<0.001
72575828|NCT04036799|144677748|OTHER|Categorical variables were summarized using frequencies and proportions.|Cumulative proportion of events at 5 yrs|9.1|||||TWO_SIDED|95.0||||||||||||
72575829|NCT04308226|144677749|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
72575830|NCT04308226|144677751|SUPERIORITY||||||<|0.001|||||||Log Rank|||||||<0.001
72575831|NCT03610516|144677758|OTHER|A repeated measures mixed model was fitted with factors for treatment group (CFZ533 or placebo) and visit.|Ratio of geometric means CFZ533/placebo|0.579||||0.0788|TWO_SIDED|95.0|0.267|1.256||one-sided p-value|Repeated measures Mixed Model|||||1.256|0.267|0.0788
72409924|NCT00274716|144328247|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.1|STANDARD_ERROR_OF_MEAN|4.4||0.066|TWO_SIDED|95.0|-16.7|0.5|||ANCOVA|Treatment group and ambulatory blood pressure measurement (ABPM; yes or no) as class variables and baseline LDL-C as a continuous variable||||0.5|-16.7|0.066
72409925|NCT00274716|144328247|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.5|STANDARD_ERROR_OF_MEAN|4.5||0.319|TWO_SIDED|95.0|-13.4|4.4|||ANCOVA|Treatment group and ambulatory blood pressure measurement (ABPM; yes or no) as class variables and baseline LDL-C as a continuous variable||||4.4|-13.4|0.319
72409926|NCT00274716|144328247|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.8|STANDARD_ERROR_OF_MEAN|4.4||0.077|TWO_SIDED|95.0|-16.4|0.8|||ANCOVA|Treatment group and ambulatory blood pressure measurement (ABPM; yes or no) as class variables and baseline LDL-C as a continuous variable||||0.8|-16.4|0.077
72409927|NCT00274716|144328247|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.6|STANDARD_ERROR_OF_MEAN|4.4||0.418|TWO_SIDED|95.0|-12.2|5.1|||ANCOVA|Treatment group and ambulatory blood pressure measurement (ABPM; yes or no) as class variables and baseline LDL-C as a continuous variable||||5.1|-12.2|0.418
72409928|NCT00274716|144328248|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.3|STANDARD_ERROR_OF_MEAN|2.5||0.015|TWO_SIDED|95.0|-11.3|-1.2|||ANCOVA|Treatment group and ambulatory blood pressure measurement (ABPM; yes or no) as class variables and baseline HDL-C as a continuous variable||||-1.2|-11.3|0.015
72409929|NCT00274716|144328248|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.0|STANDARD_ERROR_OF_MEAN|2.6||0.124|TWO_SIDED|95.0|-9.2|1.1|||ANCOVA|Treatment group and ambulatory blood pressure measurement (ABPM; yes or no) as class variables and baseline HDL-C as a continuous variable||||1.1|-9.2|0.124
72409930|NCT00274716|144328248|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.1|STANDARD_ERROR_OF_MEAN|2.6||0.429|TWO_SIDED|95.0|-3.1|7.2|||ANCOVA|Treatment group and ambulatory blood pressure measurement (ABPM; yes or no) as class variables and baseline HDL-C as a continuous variable||||7.2|-3.1|0.429
72575832|NCT01328379|144677769|SUPERIORITY_OR_OTHER||least squares mean|0.054|STANDARD_ERROR_OF_MEAN|0.0724||0.457|TWO_SIDED|95.0|-0.088|0.196||To demonstrate study sensitivity with respect to efficacy and maintain an overall alpha level ≤ 0.05, a stepwise procedure was performed.|ANOVA|ANOVA Model: Change from Baseline in Walking Speed - dependent variable and Baseline Walking Speed and Treatment - independent variables||dalfampridine-ER 5mg twice daily vs. placebo twice daily: Change from baseline in walking speed at Approximately CmaxSS at Visit 3||0.196|-0.088|0.457
72575833|NCT01328379|144677769|SUPERIORITY_OR_OTHER||least squares mean|0.118|STANDARD_ERROR_OF_MEAN|0.0732||0.107|TWO_SIDED|95.0|-0.026|0.262|||ANOVA|ANOVA Model: Change from Baseline in Walking Speed - dependent variable and Baseline Walking Speed and Treatment - independent variables||dalfampridine-ER 10mg twice daily vs. placebo twice daily: Change from baseline in walking speed at Approximately CmaxSS at Visit 3||0.262|-0.026|0.107
72575834|NCT01328379|144677769|SUPERIORITY_OR_OTHER||least squares mean|0.064|STANDARD_ERROR_OF_MEAN|0.0724||0.375|TWO_SIDED|95.0|-0.078|0.207|||ANOVA|ANOVA Model: Change from Baseline in Walking Speed - dependent variable and Baseline Walking Speed and Treatment - independent variables||dalfampridine-ER 5mg twice daily vs. dalfampridine-ER 10mg twice daily: Change from baseline in walking speed at Approximately CmaxSS at Visit 3||0.207|-0.078|0.375
72575835|NCT01328379|144677770|SUPERIORITY_OR_OTHER||Least Squares Mean|-0.014|STANDARD_ERROR_OF_MEAN|0.0666||0.832|TWO_SIDED|95.0|-0.145|0.117||To demonstrate study sensitivity with respect to efficacy and maintain an overall alpha level ≤ 0.05, a stepwise procedure was performed.|ANOVA|ANOVA Model: Change from Baseline in Walking Speed - dependent variable and Baseline Walking Speed and Treatment - independent variables||dalfampridine-ER 5mg twice daily vs. placebo twice daily: Change from baseline in walking speed at Approximately CminSS at Visit 3||0.117|-0.145|0.832
72627749|NCT00565409|144783955|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.85|||<|0.0001|TWO_SIDED|95.0|-16.6|-9.0||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 72||-9.0|-16.6|<0.0001
72627750|NCT00565409|144783955|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.87|||<|0.0001|TWO_SIDED|95.0|-18.6|-11.1||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 80||-11.1|-18.6|<0.0001
72409931|NCT00274716|144328248|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.3|STANDARD_ERROR_OF_MEAN|2.5||0.001|TWO_SIDED|95.0|-13.3|-3.4|||ANCOVA|Treatment group and ambulatory blood pressure measurement (ABPM; yes or no) as class variables and baseline HDL-C as a continuous variable||||-3.4|-13.3|0.001
72409932|NCT00274716|144328248|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.1|STANDARD_ERROR_OF_MEAN|2.5||0.018|TWO_SIDED|95.0|-11.1|-1.1|||ANCOVA|Treatment group and ambulatory blood pressure measurement (ABPM; yes or no) as class variables and baseline HDL-C as a continuous variable||||-1.1|-11.1|0.018
72409933|NCT00274716|144328249|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.9|STANDARD_ERROR_OF_MEAN|9.0||0.587|TWO_SIDED|95.0|-12.9|22.8|||ANCOVA|Treatment group and ambulatory blood pressure measurement (ABPM; yes or no) as class variables and baseline TG as a continuous variable||||22.8|-12.9|0.587
72409934|NCT00274716|144328249|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.3|STANDARD_ERROR_OF_MEAN|9.2||0.562|TWO_SIDED|95.0|-23.5|12.8|||ANCOVA|Treatment group and ambulatory blood pressure measurement (ABPM; yes or no) as class variables and baseline TG as a continuous variable||||12.8|-23.5|0.562
72409935|NCT00274716|144328249|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.3|STANDARD_ERROR_OF_MEAN|9.2||0.802|TWO_SIDED|95.0|-15.8|20.4|||ANCOVA|Treatment group and ambulatory blood pressure measurement (ABPM; yes or no) as class variables and baseline TG as a continuous variable||||20.4|-15.8|0.802
72409936|NCT00274716|144328249|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|2.6|STANDARD_ERROR_OF_MEAN|9.0||0.772|TWO_SIDED|95.0|-15.2|20.5|||ANCOVA|Treatment group and ambulatory blood pressure measurement (ABPM; yes or no) as class variables and baseline TG as a continuous variable||||20.5|-15.2|0.772
72409937|NCT00274716|144328249|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.6|STANDARD_ERROR_OF_MEAN|9.2||0.409|TWO_SIDED|95.0|-25.9|10.6|||ANCOVA|Treatment group and ambulatory blood pressure measurement (ABPM; yes or no) as class variables and baseline TG as a continuous variable||||10.6|-25.9|0.409
72409938|NCT01162005|144328254|SUPERIORITY_OR_OTHER|||||||0.001|||||||t-test, 2 sided|||||||0.001
72409939|NCT00982319|144328256|SUPERIORITY|||||||0.32|||||||Wilcoxon (Mann-Whitney)|||||||0.32
72627751|NCT00565409|144783955|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.56||||0.1808|TWO_SIDED|95.0|-6.3|1.2||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 80||1.2|-6.3|0.1808
72627752|NCT00565409|144783955|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.31|||<|0.0001|TWO_SIDED|95.0|-16.1|-8.5||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 80||-8.5|-16.1|<0.0001
72627753|NCT00565409|144783955|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.7|||<|0.0001|TWO_SIDED|95.0|-18.5|-10.9||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 88||-10.9|-18.5|<0.0001
72627754|NCT00565409|144783955|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.44||||0.2077|TWO_SIDED|95.0|-6.2|1.4||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 88||1.4|-6.2|0.2077
72627755|NCT00565409|144783955|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.26|||<|0.0001|TWO_SIDED|95.0|-16.1|-8.5||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 88||-8.5|-16.1|<0.0001
72627756|NCT00565409|144783956|SUPERIORITY_OR_OTHER|||||||0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.0001
72627757|NCT00565409|144783957|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.1||||0.8974|TWO_SIDED|95.0|0.5|2.5||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 36||2.5|0.5|0.8974
72627758|NCT00565409|144783957|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.67||||0.1105|TWO_SIDED|95.0|0.8|3.7||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 36||3.7|0.8|0.1105
72627759|NCT00565409|144783957|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.67||||0.19|TWO_SIDED|95.0|0.3|1.4||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 36||1.4|0.3|0.1900
72627760|NCT00565409|144783957|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.18|||<|0.0001|TWO_SIDED|95.0|2.3|7.5||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 64||7.5|2.3|<0.0001
72627761|NCT00565409|144783957|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.24||||0.4032|TWO_SIDED|95.0|0.6|2.4||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 64||2.4|0.6|0.4032
72627762|NCT00565409|144783957|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.23|||<|0.0001|TWO_SIDED|95.0|2.4|7.5||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 64||7.5|2.4|<0.0001
72627763|NCT00565409|144783957|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.92|||<|0.0001|TWO_SIDED|95.0|2.1|7.2||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 88||7.2|2.1|<0.0001
72627764|NCT00565409|144783957|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.9||||0.0272|TWO_SIDED|95.0|1.0|3.6||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 88||3.6|1.0|0.0272
72627765|NCT00565409|144783957|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.34||||0.0004|TWO_SIDED|95.0|1.4|4.0||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 88||4.0|1.4|0.0004
72627766|NCT00565409|144783958|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|95.0|||||Cochran-Mantel-Haenszel|||Week 4||||<0.0001
72627767|NCT00565409|144783958|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 8||||<0.0001
72627768|NCT00565409|144783958|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 12||||<0.0001
72627769|NCT00565409|144783958|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 20||||<0.0001
72627770|NCT00565409|144783958|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 28||||<0.0001
72627771|NCT00565409|144783958|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 36||||<0.0001
72627772|NCT00565409|144783959|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.29||||0.1718|TWO_SIDED|95.0|0.5|10.7||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 36||10.7|0.5|0.1718
72627773|NCT00565409|144783959|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.17||||0.8303|TWO_SIDED|95.0|0.2|7.3||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 36||7.3|0.2|0.8303
72627774|NCT00565409|144783959|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.27||||0.213|TWO_SIDED|95.0|0.5|10.1||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 36||10.1|0.5|0.2130
72627775|NCT00565409|144783959|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.1|||<|0.0001|TWO_SIDED|95.0|2.1|8.2||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 40||8.2|2.1|<0.0001
72409940|NCT01923181|144328274|SUPERIORITY|This hypothesis was controlled for multiplicity.|Mean treatment difference|-1.47|||<|0.0001|TWO_SIDED|95.0|-1.73|-1.22|||Mixed Models Analysis||Oral semaglutide 40 mg pooled - Placebo|Results are based on the data from the on-treatment without rescue medication observation period. The analysis was based on mixed model for repeated measurements with treatment, stratum and country as fixed factors and baseline value as covariate, all nested within visit. Group mean estimates were adjusted according to observed baseline distribution.||-1.22|-1.73|<0.0001
72409941|NCT01923181|144328274|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Treatment difference|-0.4||||0.0069|TWO_SIDED|95.0|-0.69|-0.11|||Mixed Models Analysis||Oral semaglutide 2.5 mg - Placebo|Results are based on the data from the on-treatment without rescue medication observation period. The analysis was based on mixed model for repeated measurements with treatment, stratum and country as fixed factors and baseline value as covariate, all nested within visit. Group mean estimates were adjusted according to observed baseline distribution.||-0.11|-0.69|0.0069
72409942|NCT01923181|144328274|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Treatment difference|-0.89|||<|0.0001|TWO_SIDED|95.0|-1.18|-0.6|||Mixed Models Analysis||Oral semaglutide 5 mg - Placebo|Results are based on the data from the on-treatment without rescue medication observation period. The analysis was based on mixed model for repeated measurements with treatment, stratum and country as fixed factors and baseline value as covariate, all nested within visit. Group mean estimates were adjusted according to observed baseline distribution.||-0.60|-1.18|<0.0001
72409943|NCT01923181|144328274|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Treatment difference|-1.18|||<|0.0001|TWO_SIDED|95.0|-1.47|-0.9|||Mixed Models Analysis||Oral semaglutide 10 mg - Placebo|Results are based on the data from the on-treatment without rescue medication observation period. The analysis was based on mixed model for repeated measurements with treatment, stratum and country as fixed factors and baseline value as covariate, all nested within visit. Group mean estimates were adjusted according to observed baseline distribution.||-0.90|-1.47|<0.0001
72409944|NCT01923181|144328274|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Treatment difference|-1.38|||<|0.0001|TWO_SIDED|95.0|-1.68|-1.09|||Mixed Models Analysis||Oral Semaglutide 20 mg - Placebo|Results are based on the data from the on-treatment without rescue medication observation period. The analysis was based on mixed model for repeated measurements with treatment, stratum and country as fixed factors and baseline value as covariate, all nested within visit. Group mean estimates were adjusted according to observed baseline distribution.||-1.09|-1.68|<0.0001
72409945|NCT01923181|144328274|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Treatment difference|-1.6|||<|0.0001|TWO_SIDED|95.0|-1.89|-1.3|||Mixed Models Analysis||Oral semaglutide 40 mg - Placebo|Results are based on the data from the on-treatment without rescue medication observation period. The analysis was based on mixed model for repeated measurements with treatment, stratum and country as fixed factors and baseline value as covariate, all nested within visit. Group mean estimates were adjusted according to observed baseline distribution.||-1.30|-1.89|<0.0001
72409946|NCT01923181|144328274|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Treatment difference|-1.43|||<|0.0001|TWO_SIDED|95.0|-1.72|-1.14|||Mixed Models Analysis||Oral semaglutide 40 mg slow dose-escalation - Placebo|Results are based on the data from the on-treatment without rescue medication observation period. The analysis was based on mixed model for repeated measurements with treatment, stratum and country as fixed factors and baseline value as covariate, all nested within visit. Group mean estimates were adjusted according to observed baseline distribution.||-1.14|-1.72|<0.0001
72409947|NCT01923181|144328274|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Treatment difference|-1.34|||<|0.0001|TWO_SIDED|95.0|-1.64|-1.04|||Mixed Models Analysis||Oral semaglutide 40 mg fast dose-escalation - Placebo|Results are based on the data from the on-treatment without rescue medication observation period. The analysis was based on mixed model for repeated measurements with treatment, stratum and country as fixed factors and baseline value as covariate, all nested within visit. Group mean estimates were adjusted according to observed baseline distribution.||-1.04|-1.64|<0.0001
72575836|NCT01328379|144677770|SUPERIORITY_OR_OTHER||Least Squares Mean|0.093|STANDARD_ERROR_OF_MEAN|0.0674||0.167|TWO_SIDED|95.0|-0.039|0.226|||ANOVA|ANOVA Model: Change from Baseline in Walking Speed - dependent variable and Baseline Walking Speed and Treatment - independent variables||dalfampridine-ER 10mg twice daily vs. placebo twice daily: Change from baseline in walking speed at Approximately CminSS at Visit 3||0.226|-0.039|0.167
72575837|NCT01328379|144677770|SUPERIORITY_OR_OTHER||Least Squares Mean|0.107|STANDARD_ERROR_OF_MEAN|0.0666||0.108|TWO_SIDED|95.0|-0.024|0.238|||ANOVA|ANOVA Model: Change from Baseline in Walking Speed - dependent variable and Baseline Walking Speed and Treatment - independent variables||dalfampridine-ER 5mg twice daily vs. dalfampridine-ER 10mg twice daily: Change from baseline in walking speed at Approximately CminSS at Visit 3||0.238|-0.024|0.108
72409948|NCT01923181|144328274|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Treatment difference|-1.56|||<|0.0001|TWO_SIDED|95.0|-1.85|-1.27|||Mixed Models Analysis||Subcutaneous semaglutide 1 mg - Placebo|Results are based on the data from the on-treatment without rescue medication observation period. The analysis was based on mixed model for repeated measurements with treatment, stratum and country as fixed factors and baseline value as covariate, all nested within visit. Group mean estimates were adjusted according to observed baseline distribution.||-1.27|-1.85|<0.0001
72409949|NCT01923181|144328274|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Treatment difference|1.16|||<|0.0001|TWO_SIDED|95.0|0.87|1.45|||Mixed Models Analysis||Oral semaglutide 2.5 mg - Subcutaneous semaglutide 1 mg|Results are based on the data from the on-treatment without rescue medication observation period. The analysis was based on mixed model for repeated measurements with treatment, stratum and country as fixed factors and baseline value as covariate, all nested within visit. Group mean estimates were adjusted according to observed baseline distribution.||1.45|0.87|<0.0001
72575838|NCT01328379|144677771|SUPERIORITY_OR_OTHER||Lease Squares Mean|-0.4|STANDARD_ERROR_OF_MEAN|2.367||0.866|TWO_SIDED|95.0|-5.05|4.25|||ANOVA|ANOVA model with change from baseline in MSWS-12 Score as the dependent variable and baseline MSWS-12 Score and treatment as the independent variables||dalfampridine-ER 5mg twice daily vs. placebo twice daily: Change from baseline in MSWS-12 at visit 3||4.25|-5.05|0.866
72409950|NCT01923181|144328274|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Treatment difference|0.67|||<|0.0001|TWO_SIDED|95.0|0.38|0.96|||Mixed Models Analysis||Oral semaglutide 5 mg - Subcutaneous semaglutide 1 mg|Results are based on the data from the on-treatment without rescue medication observation period. The analysis was based on mixed model for repeated measurements with treatment, stratum and country as fixed factors and baseline value as covariate, all nested within visit. Group mean estimates were adjusted according to observed baseline distribution.||0.96|0.38|<0.0001
72409951|NCT01923181|144328274|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Treatment difference|0.37||||0.0116|TWO_SIDED|95.0|0.08|0.67|||Mixed Models Analysis||Oral semaglutide 10 mg - Subcutaneous semaglutide 1 mg|Results are based on the data from the on-treatment without rescue medication observation period. The analysis was based on mixed model for repeated measurements with treatment, stratum and country as fixed factors and baseline value as covariate, all nested within visit. Group mean estimates were adjusted according to observed baseline distribution.||0.67|0.08|0.0116
72409952|NCT01923181|144328274|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Treatment difference|0.18||||0.244|TWO_SIDED|95.0|-0.12|0.47|||Mixed Models Analysis||Oral semaglutide 20 mg - Subcutaneous semaglutide 1 mg|Results are based on the data from the on-treatment without rescue medication observation period. The analysis was based on mixed model for repeated measurements with treatment, stratum and country as fixed factors and baseline value as covariate, all nested within visit. Group mean estimates were adjusted according to observed baseline distribution.||0.47|-0.12|0.2440
72409953|NCT01923181|144328274|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Treatment difference|-0.04||||0.7973|TWO_SIDED|95.0|-0.34|0.26|||Mixed Models Analysis||Oral semaglutide 40 mg - Subcutaneous semaglutide 1 mg|Results are based on the data from the on-treatment without rescue medication observation period. The analysis was based on mixed model for repeated measurements with treatment, stratum and country as fixed factors and baseline value as covariate, all nested within visit. Group mean estimates were adjusted according to observed baseline distribution.||0.26|-0.34|0.7973
72409954|NCT01923181|144328274|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Treatment difference|0.13||||0.3901|TWO_SIDED|95.0|-0.16|0.42|||Mixed Models Analysis||Oral semaglutide 40 mg slow-dose escalation - Subcutaneous semaglutide 1 mg|Results are based on the data from the on-treatment without rescue medication observation period. The analysis was based on mixed model for repeated measurements with treatment, stratum and country as fixed factors and baseline value as covariate, all nested within visit. Group mean estimates were adjusted according to observed baseline distribution.||0.42|-0.16|0.3901
72409955|NCT01923181|144328274|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Treatment difference|0.22||||0.1612|TWO_SIDED|95.0|-0.09|0.52|||Mixed Models Analysis||Oral semaglutide 40 mg fast-dose escalation - Subcutaneous semaglutide 1 mg|Results are based on the data from the on-treatment without rescue medication observation period. The analysis was based on mixed model for repeated measurements with treatment, stratum and country as fixed factors and baseline value as covariate, all nested within visit. Group mean estimates were adjusted according to observed baseline distribution.||0.52|-0.09|0.1612
72575839|NCT01328379|144677771|SUPERIORITY_OR_OTHER||Least Squares Mean|-2.56|STANDARD_ERROR_OF_MEAN|2.393||0.286|TWO_SIDED|95.0|-7.26|2.15|||ANOVA|ANOVA model with change from baseline in MSWS-12 Score as the dependent variable and baseline MSWS-12 Score and treatment as the independent variables||dalfampridine-ER 10mg twice daily vs. placebo twice daily: Change from baseline in MSWS-12 at visit 3||2.15|-7.26|0.286
72575840|NCT01328379|144677771|SUPERIORITY_OR_OTHER||Least Squares Mean|-2.16|STANDARD_ERROR_OF_MEAN|2.366||0.362|TWO_SIDED|95.0|-6.81|2.49|||ANOVA|ANOVA model with change from baseline in MSWS-12 Score as the dependent variable and baseline MSWS-12 Score and treatment as the independent variables||dalfampridine-ER 5mg twice daily vs. dalfampridine-ER 10mg twice daily: Change from baseline in MSWS-12 at visit 3||2.49|-6.81|0.362
72575841|NCT01328379|144677772|SUPERIORITY_OR_OTHER||Least Squares Mean|0.84|STANDARD_ERROR_OF_MEAN|2.237||0.708|TWO_SIDED|95.0|-3.56|5.24|||ANOVA|ANOVA model with change from baseline in MSWS-12 Score as the dependent variable and baseline MSWS-12 Score and treatment as the independent variables||dalfampridine-ER 5mg twice daily vs. placebo twice daily: Change from baseline in MSWS-12 at visit 2||5.24|-3.56|0.708
72575842|NCT01328379|144677772|SUPERIORITY_OR_OTHER||Least Squares Mean|-0.38|STANDARD_ERROR_OF_MEAN|2.258||0.868|TWO_SIDED|95.0|-4.81|4.06|||ANOVA|ANOVA model with change from baseline in MSWS-12 Score as the dependent variable and baseline MSWS-12 Score and treatment as the independent variables||dalfampridine-ER 10mg twice daily vs. placebo twice daily: Change from baseline in MSWS-12 at visit 2||4.06|-4.81|0.868
72575843|NCT01328379|144677772|SUPERIORITY_OR_OTHER||Least Squares Mean|-1.21|STANDARD_ERROR_OF_MEAN|2.236||0.588|TWO_SIDED|95.0|-5.61|3.18|||ANOVA|ANOVA model with change from baseline in MSWS-12 Score as the dependent variable and baseline MSWS-12 Score and treatment as the independent variables||dalfampridine-ER 5mg twice daily vs. dalfampridine-ER 10mg twice daily: Change from baseline in MSWS-12 at visit 2||3.18|-5.61|0.588
72575844|NCT01328379|144677773|SUPERIORITY_OR_OTHER||Least Squares Mean|35.4|STANDARD_ERROR_OF_MEAN|34.57||0.308|TWO_SIDED|95.0|-33.0|103.7|||ANOVA|Change from Baseline in Six-Minute Walk Distance as dependent variable and Baseline Six-Minute Walk Distance and Treatment as independent variables.||dalfampridine-ER 5mg twice daily vs. placebo twice daily: Change from baseline in Six-Minute Walk Distance at visit 2||103.7|-33.0|0.308
72575845|NCT01328379|144677773|SUPERIORITY_OR_OTHER||Least Squares Mean|87.1|STANDARD_ERROR_OF_MEAN|34.9||0.014|TWO_SIDED|95.0|18.2|156.1|||ANOVA|Change from Baseline in Six-Minute Walk Distance as dependent variable and Baseline Six-Minute Walk Distance and Treatment as independent variables.||dalfampridine-ER 10mg twice daily vs. placebo twice daily: Change from baseline in Six-Minute Walk Distance at visit 2||156.1|18.2|0.014
72575846|NCT01328379|144677773|SUPERIORITY_OR_OTHER||Least Squares Mean|51.7|STANDARD_ERROR_OF_MEAN|34.21||0.133|TWO_SIDED|95.0|-15.9|119.3|||ANOVA|Change from Baseline in Six-Minute Walk Distance as dependent variable and Baseline Six-Minute Walk Distance and Treatment as independent variables.||dalfampridine-ER 5mg twice daily vs. dalfampridine-ER 10mg twice daily: Change from baseline in Six-Minute Walk Distance at visit 2||119.3|-15.9|0.133
72575847|NCT01328379|144677774|SUPERIORITY_OR_OTHER||Least Squares Mean|0.0|STANDARD_ERROR_OF_MEAN|0.03||0.32|TWO_SIDED|95.0|0.0|0.1|||ANOVA|ANOVA model with change from baseline score as the dependant variable and baseline score and treatment as the independent variables.||dalfampridine-ER 5mg twice daily vs. placebo twice daily: Change from baseline in Average EQ-5D score at Visit 3||0.1|-0.0|0.320
72627776|NCT00565409|144783959|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.81||||0.4337|TWO_SIDED|95.0|0.3|2.0||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 40||2.0|0.3|0.4337
72627777|NCT00565409|144783959|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.14|||<|0.0001|TWO_SIDED|95.0|2.5|10.8||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 40||10.8|2.5|<0.0001
72627778|NCT00565409|144783959|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.61|||<|0.0001|TWO_SIDED|95.0|3.0|10.5||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 48||10.5|3.0|<0.0001
72627779|NCT00565409|144783959|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.88||||0.8973|TWO_SIDED|95.0|0.4|1.9||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 48||1.9|0.4|0.8973
72627780|NCT00565409|144783959|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.33|||<|0.0001|TWO_SIDED|95.0|2.8|10.1||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 48||10.1|2.8|<0.0001
72627781|NCT00565409|144783959|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.4|||<|0.0001|TWO_SIDED|95.0|2.4|8.1||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 56||8.1|2.4|<0.0001
72575848|NCT01328379|144677774|SUPERIORITY_OR_OTHER||Least Squares Mean|0.0|STANDARD_ERROR_OF_MEAN|0.03||0.734|TWO_SIDED|95.0|-0.1|0.0|||ANOVA|ANOVA model with change from baseline score as the dependant variable and baseline score and treatment as the independent variables.||dalfampridine-ER 10mg twice daily vs. placebo twice daily: Change from baseline in Average EQ-5D score at Visit 3||0.0|-0.1|0.734
72575849|NCT01328379|144677774|SUPERIORITY_OR_OTHER||Least Squares Mean|0.0|STANDARD_ERROR_OF_MEAN|0.03||0.185|TWO_SIDED|95.0|-0.1|0.0|||ANOVA|ANOVA model with change from baseline score as the dependant variable and baseline score and treatment as the independent variables.||dalfampridine-ER 5mg twice daily vs. dalfampridine-ER 10mg twice daily: Change from baseline in Average EQ-5D score at Visit 3||0.0|-0.1|0.185
72575850|NCT01328379|144677775|SUPERIORITY_OR_OTHER||Least Squares Mean|-3.4|STANDARD_ERROR_OF_MEAN|1.79||0.055|TWO_SIDED|95.0|-7.0|0.1|||ANOVA|ANOVA model with change from baseline score as the dependant variable and baseline score and treatment as the independent variables.||dalfampridine-ER 5mg twice daily vs. placebo twice daily: Change from baseline in EQ-5D VAS score at Visit 3||0.1|-7.0|0.055
72575851|NCT01328379|144677775|SUPERIORITY_OR_OTHER||Least Squares Mean|-1.2|STANDARD_ERROR_OF_MEAN|1.83||0.53|TWO_SIDED|95.0|-4.7|2.4|||ANOVA|ANOVA model with change from baseline score as the dependant variable and baseline score and treatment as the independent variables.||dalfampridine-ER 10mg twice daily vs. placebo twice daily: Change from baseline in EQ-5D VAS score at Visit 3||2.4|-4.7|0.530
72575852|NCT01328379|144677775|SUPERIORITY_OR_OTHER||Least Squares Mean|2.3|STANDARD_ERROR_OF_MEAN|1.8||0.203|TWO_SIDED|95.0|-1.2|5.8|||ANOVA|ANOVA model with change from baseline score as the dependant variable and baseline score and treatment as the independent variables.||dalfampridine-ER 5mg twice daily vs. dalfampridine-ER 10mg twice daily: Change from baseline in EQ-5D VAS score at Visit 3||5.8|-1.2|0.203
72575853|NCT00660907|144677776|NON_INFERIORITY_OR_EQUIVALENCE|non-inferior margin delta = 0.35|Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.0569|<|0.0001|TWO_SIDED|95.0|-0.11|0.11||Significant at alpha=0.025 (1-sided). A hierarchical closed testing procedure was used to control Type I error across the primary \& key secondary objectives|ANCOVA|with treatment group as effect and baseline value as covariate||The null hypothesis is given as H0: mean(treat) minus mean(reference) \>= delta versus the alternative HA: mean(treat) minus mean(reference) \< delta (with alpha = 0.025, one-sided)||0.11|-0.11|<0.0001
72575854|NCT00660907|144677777|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.65|STANDARD_ERROR_OF_MEAN|0.2483|<|0.0001|TWO_SIDED|95.0|-5.14|-4.17||Significant at alpha=0.05 (2-sided). Key secondary endpoints are tested following a hierarchical closed testing procedure|ANCOVA|with treatment group as effect and baseline value as covariate||H0: mean(treat) minus mean(reference) = 0 versus the alternative HA: mean(treat) minus mean(reference) =/= 0||-4.17|-5.14|<0.0001
72575855|NCT00660907|144677778|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-37.2|STANDARD_ERROR_OF_MEAN|2.578|<|0.0001|TWO_SIDED|95.0|-42.3|-32.2||Significant at alpha=0.05 (2-sided). Key secondary endpoints are tested following a hierarchical closed testing procedure|Regression, Logistic|Based on methodology of Zhang, Tsiatis \& Davidian and Davidian, Tsiatis, Zhang \& Lu, with adjustment for baseline value.||H0: proportion(treat) minus proportion(reference) = 0 versus the alternative HA: proportion(treat) minus proportion(reference) =/= 0||-32.2|-42.3|<0.0001
72627782|NCT00565409|144783959|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.81||||0.5708|TWO_SIDED|95.0|0.4|1.7||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 56||1.7|0.4|0.5708
72627783|NCT00565409|144783959|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.58|||<|0.0001|TWO_SIDED|95.0|3.0|10.3||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 56||10.3|3.0|<0.0001
72627784|NCT00565409|144783959|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.29|||<|0.0001|TWO_SIDED|95.0|3.3|12.0||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 64||12.0|3.3|<0.0001
72627785|NCT00565409|144783959|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.91||||0.8842|TWO_SIDED|95.0|0.4|2.0||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 64||2.0|0.4|0.8842
72409956|NCT01923181|144328274|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Treatment difference|0.17||||0.2669|TWO_SIDED|95.0|-0.13|0.46|||Mixed Models Analysis||Oral semaglutide 40 mg slow-dose escalation - Oral semaglutide 40 mg|Results are based on the data from the on-treatment without rescue medication observation period. The analysis was based on mixed model for repeated measurements with treatment, stratum and country as fixed factors and baseline value as covariate, all nested within visit. Group mean estimates were adjusted according to observed baseline distribution.||0.46|-0.13|0.2669
72409957|NCT01923181|144328274|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Treatment difference|0.26||||0.0989|TWO_SIDED|95.0|-0.05|0.56|||Mixed Models Analysis||Oral semaglutide 40 mg fast-dose escalation - Oral semaglutide 40 mg|Results are based on the data from the on-treatment without rescue medication observation period. The analysis was based on mixed model for repeated measurements with treatment, stratum and country as fixed factors and baseline value as covariate, all nested within visit. Group mean estimates were adjusted according to observed baseline distribution.||0.56|-0.05|0.0989
72409958|NCT01923181|144328274|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Treatment difference|0.09||||0.5565|TWO_SIDED|95.0|-0.21|0.39|||Mixed Models Analysis||Oral semaglutide 40 mg fast-dose escalation - Oral semaglutide 40 mg slow-dose escalation|Results are based on the data from the on-treatment without rescue medication observation period. The analysis was based on mixed model for repeated measurements with treatment, stratum and country as fixed factors and baseline value as covariate, all nested within visit. Group mean estimates were adjusted according to observed baseline distribution.||0.39|-0.21|0.5565
72409959|NCT01863446|144328292|SUPERIORITY|Unpaired t-test comparing Lighting 1 and Lighting2||||||0.334|||||||t-test, 2 sided|||||||0.334
72575856|NCT00660907|144677779|SUPERIORITY_OR_OTHER||Risk Difference (RD)|30.8|STANDARD_ERROR_OF_MEAN|2.48|<|0.0001|TWO_SIDED|95.0|26.0|35.7||Significant at alpha=0.05 (2-sided). Key secondary endpoints are tested following a hierarchical closed testing procedure|Regression, Logistic|Based on methodology of Zhang, Tsiatis \& Davidian and Davidian, Tsiatis, Zhang \& Lu, with adjustment for baseline value.||H0: proportion(treat) minus proportion(reference) = 0 versus the alternative HA: proportion(treat) minus proportion(reference) =/= 0||35.7|26.0|<0.0001
72575857|NCT00618332|144677806|SUPERIORITY_OR_OTHER|||||||0.372||95.0|||||t-test, 2 sided|||||||0.372
72575858|NCT00618332|144677807|SUPERIORITY_OR_OTHER|||||||0.775||95.0|||||t-test, 2 sided|||||||0.775
72575859|NCT00618332|144677808|SUPERIORITY_OR_OTHER|||||||0.737||95.0|||||t-test, 2 sided|||||||0.737
72575860|NCT00618332|144677809|SUPERIORITY_OR_OTHER|||||||0.117||95.0|||||t-test, 2 sided|||||||0.117
72575861|NCT00618332|144677810|SUPERIORITY_OR_OTHER|||||||0.676||95.0|||||t-test, 2 sided|||||||0.676
72575862|NCT00618332|144677811|SUPERIORITY_OR_OTHER|||||||0.795||95.0|||||t-test, 2 sided|||||||0.795
72575863|NCT00618332|144677812|SUPERIORITY_OR_OTHER|||||||0.638||95.0|||||t-test, 2 sided|||||||0.638
72575864|NCT00618332|144677813|SUPERIORITY_OR_OTHER|||||||0.8||95.0|||||t-test, 2 sided|||||||0.800
72575865|NCT00618332|144677814|SUPERIORITY_OR_OTHER|||||||0.968||95.0|||||t-test, 2 sided|||||||0.968
72575866|NCT05773794|144677815|SUPERIORITY|||||||0.968|||||||t-test, 2 sided|||||||0.968
72627786|NCT00565409|144783959|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.92|||<|0.0001|TWO_SIDED|95.0|3.2|10.8||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 64||10.8|3.2|<0.0001
72575867|NCT05773794|144677815|SUPERIORITY|||||||0.366|||||||t-test, 2 sided|||||||0.366
72575868|NCT05773794|144677815|SUPERIORITY||||||>|0.05|||||||t-test, 2 sided|||||||>0.05
72575869|NCT05773794|144677816|SUPERIORITY|||||||0.016|||||||t-test, 2 sided|||||||0.016
72575870|NCT05773794|144677816|SUPERIORITY|||||||0.11|||||||t-test, 2 sided|||||||0.11
72575871|NCT05773794|144677816|SUPERIORITY|||||||0.59|||||||t-test, 2 sided|||||||0.59
72575872|NCT05773794|144677817|SUPERIORITY|||||||0.0196|||||||t-test, 2 sided|||||||0.0196
72575873|NCT05773794|144677817|SUPERIORITY||||||>|0.05|||||||t-test, 2 sided|||||||>0.05
72575874|NCT05773794|144677817|SUPERIORITY||||||>|0.05|||||||t-test, 2 sided|||||||>0.05
72575875|NCT03323437|144677860|OTHER|two way anova|||||<|0.01|||||||ANOVA|||||||<0.01
72575876|NCT03323437|144677861|OTHER|two way anova||||||0.68|||||||ANOVA|||||||.68
72575877|NCT03323437|144677862|OTHER|two way anova||||||0.03|||||||ANOVA|||||||.03
72575878|NCT03323437|144677863|OTHER|two way anova||||||0.01|||||||ANOVA|||||||.01
72575879|NCT03323437|144677864|OTHER|two sided t test||||||0.59|||||||t-test, 2 sided|||||||.59
72575880|NCT03323437|144677865|OTHER|two sided t test||||||0.45|||||||t-test, 2 sided|||||||.45
72575881|NCT03323437|144677866|OTHER|two way anova||||||0.32|||||||ANOVA|||||||.32
72575882|NCT03323437|144677867|OTHER|two way anova||||||0.6|||||||ANOVA|||||||.60
72575883|NCT03323437|144677868|OTHER|two way anova||||||0.34|||||||ANOVA|||||||.34
72575884|NCT03323437|144677869|OTHER|two way anova||||||0.35|||||||ANOVA|||||||.35
72575885|NCT03323437|144677870|OTHER|fisher's exact||||||0.66|||||||Fisher Exact|||||||.66
72575886|NCT03323437|144677871|OTHER|two sided t test||||||0.04|||||||t-test, 2 sided|||||||.04
72575887|NCT03323437|144677872|OTHER|fisher's exact test||||||1|||||||Fisher Exact|||||||1
72575888|NCT01386983|144677877|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|3.406||||0.0128|TWO_SIDED|95.0|1.297|8.941|||Regression, Cox|||||8.941|1.297|0.0128
72575889|NCT01386983|144677878|SUPERIORITY_OR_OTHER|||||||0.0002||95.0|||||Generalized linear model|Gamma distribution with log-link function was used.||||||0.0002
72575890|NCT04746794|144677922|SUPERIORITY|||||||0.0074|||||||Chi-squared|||||||0.0074
72575891|NCT04746794|144677923|SUPERIORITY||||||<|0.0001|||||||Chi-squared|||||||<0.0001
72575892|NCT04040192|144677929|OTHER|||||||0.0034||||||p-value was estimated by the log-rank test, stratified by age group, duration of the BID treatment in OL period, and ISGA score at randomization.|Log Rank|||||||0.0034
72575893|NCT04040192|144677931|OTHER|Analysis of covariance (ANCOVA) model included fixed effects of treatment group, age group, duration of the BID treatment in OL period, and ISGA score at randomization.|Least square mean difference|34.59|STANDARD_ERROR_OF_MEAN|16.274||0.0346|TWO_SIDED|95.0|2.53|66.64|||ANCOVA|||||66.64|2.53|0.0346
72627787|NCT00565409|144783959|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|7.39|||<|0.0001|TWO_SIDED|95.0|3.8|14.4||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 72||14.4|3.8|<0.0001
72627788|NCT00565409|144783959|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.42||||0.1608|TWO_SIDED|95.0|0.6|3.1||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 72||3.1|0.6|0.1608
72627789|NCT00565409|144783959|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.92|||<|0.0001|TWO_SIDED|95.0|2.9|8.4||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 72||8.4|2.9|<0.0001
72627790|NCT00565409|144783959|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.44|||<|0.0001|TWO_SIDED|95.0|3.4|12.4||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 80||12.4|3.4|<0.0001
72627791|NCT00565409|144783959|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.21||||0.2825|TWO_SIDED|95.0|0.6|2.7||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 80||2.7|0.6|0.2825
72627792|NCT00565409|144783959|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.59|||<|0.0001|TWO_SIDED|95.0|2.7|7.8||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 80||7.8|2.7|<0.0001
72627793|NCT00565409|144783959|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.81|||<|0.0001|TWO_SIDED|95.0|2.7|8.7||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 88||8.7|2.7|<0.0001
72627794|NCT00565409|144783959|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.06||||0.4471|TWO_SIDED|95.0|0.5|2.1||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 88||2.1|0.5|0.4471
72627795|NCT00565409|144783959|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.19|||<|0.0001|TWO_SIDED|95.0|2.5|7.0||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 88||7.0|2.5|<0.0001
72627796|NCT00565409|144783960|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 4||||<0.0001
72627797|NCT00565409|144783960|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 8||||<0.0001
72627798|NCT00565409|144783960|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 12||||<0.0001
72627799|NCT00565409|144783960|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 20||||<0.0001
72627800|NCT00565409|144783960|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 28||||<0.0001
72627801|NCT00565409|144783960|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 36||||<0.0001
72627802|NCT00565409|144783961|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.83||||0.6006|TWO_SIDED|95.0|0.4|1.6||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 36||1.6|0.4|0.6006
72409960|NCT01863446|144328292|SUPERIORITY|Unpaired t-test comparing Lighting3 vs Lighting 4||||||0.423|||||||t-test, 2 sided|||||||0.423
72409961|NCT01863446|144328293|SUPERIORITY|Unpaired t-test of Lighting1 vs Lighting2||||||0.78|||||||t-test, 2 sided|||||||0.780
72409962|NCT01863446|144328293|SUPERIORITY|Unpaired t-test of Lighting3 vs Lighting4||||||0.791|||||||t-test, 2 sided|||||||0.791
72409963|NCT01863446|144328294|SUPERIORITY|Unpaired t-test||||||0.883|||||||t-test, 2 sided|||||||0.883
72409964|NCT01863446|144328294|SUPERIORITY|Unpaired t-test||||||0.271|||||||t-test, 2 sided|||||||0.271
72627803|NCT00565409|144783961|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.1||||0.4967|TWO_SIDED|95.0|0.6|2.1||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 36||2.1|0.6|0.4967
72627804|NCT00565409|144783961|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.76||||0.3648|TWO_SIDED|95.0|0.4|1.5||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 36||1.5|0.4|0.3648
72627805|NCT00565409|144783961|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.98||||0.0024|TWO_SIDED|95.0|1.2|3.2||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 40||3.2|1.2|0.0024
72627806|NCT00565409|144783961|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.92||||0.8308||95.0|0.6|||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 40||1.|0.6|0.8308
72627807|NCT00565409|144783961|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.13||||0.0008|TWO_SIDED|95.0|1.3|3.4||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 40||3.4|1.3|0.0008
72627808|NCT00565409|144783961|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.25|||<|0.0001|TWO_SIDED|95.0|2.0|5.2||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 48||5.2|2.0|<0.0001
72627809|NCT00565409|144783961|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.09||||0.7374|TWO_SIDED|95.0|0.7|1.8||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 48||1.8|0.7|0.7374
72627810|NCT00565409|144783961|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.04|||<|0.0001|TWO_SIDED|95.0|1.9|4.8||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 48||4.8|1.9|<0.0001
72627811|NCT00565409|144783961|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.03|||<|0.0001|TWO_SIDED|95.0|1.9|4.8||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 56||4.8|1.9|<0.0001
72409965|NCT03779997|144328300|SUPERIORITY||Risk Ratio (RR)|0.78|STANDARD_DEVIATION|0.1||0.07|TWO_SIDED|95.0|0.6|1.02||0.05 a priori threshold for statistical significance.|Log-linear GEE regression|||Null hypothesis: no difference in the percentage of urine drug tests (UDT) negative for opioids between the two treatment arms.Treatment-as-usual (TAU) is the reference group.||1.02|0.60|0.07
72409966|NCT03779997|144328301|SUPERIORITY||Risk Ratio (RR)|0.84|STANDARD_DEVIATION|0.11||0.2|TWO_SIDED|95.0|0.65|1.1||0.05 a priori threshold for statistical significance.|Poisson regression with robust SEs|||Null hypothesis: no difference between treatment arms in the percentage of patients engaged in treatment at week 12. TAU is the reference group.||1.10|0.65|0.20
72409967|NCT03779997|144328302|SUPERIORITY||Risk Ratio (RR)|0.73|STANDARD_DEVIATION|0.17||0.18|TWO_SIDED|95.0|0.45|1.16||0.05 a priori threshold for statistical significance.|Poisson regression with robust SEs|||Null hypothesis: No difference between arms in the percentage of participants engaged in treatment at week 24 post-randomization. TAU is the reference group.||1.16|0.45|0.18
72409968|NCT03779997|144328303|SUPERIORITY||Median Difference (Final Values)|0.9|STANDARD_DEVIATION|0.45||0.31|TWO_SIDED|95.0|-0.9|2.7||0.05 a priori threshold for statistical significance.|t-test, 2 sided||TAU is the reference group.|Null hypothesis: No difference between arms on the number of consecutive weeks with UDT negative for opioids.||2.7|-0.9|0.31
72409969|NCT03779997|144328304|SUPERIORITY||Risk Ratio (RR)|0.71|STANDARD_DEVIATION|0.41||0.57|TWO_SIDED|95.0|0.23|2.26||0.05 a priori threshold for statistical significance.|Poisson regression with robust SEs||TAU is the reference group.|Null hypothesis: No difference between arms in the number of participants who self-reported illicit opioid use at week 12.||2.26|0.23|0.57
72409970|NCT03779997|144328305|SUPERIORITY||Risk Ratio (RR)|1.01|STANDARD_DEVIATION|0.066||0.88|TWO_SIDED|95.0|0.89|1.15||0.05 a priori threshold for statistical significance.|GEE Poisson regression||TAU is the reference group.|Null hypothesis: No difference between arms in the mean number of days adherent to buprenorphine by self-report.||1.15|0.89|0.88
72409971|NCT03779997|144328307|SUPERIORITY||Risk Ratio (RR)|1.17|STANDARD_DEVIATION|0.6||0.77|TWO_SIDED|95.0|0.42|3.24||0.05 a priori threshold for statistical significance.|Poisson regression with robust SEs||TAU is the reference group.|Null hypothesis: No difference between arms in number of participants who had one or more urine drug tests negative for buprenorphine.||3.24|0.42|0.77
72409972|NCT03779997|144328308|SUPERIORITY||Risk Ratio (RR)|0.67|STANDARD_DEVIATION|0.26||0.3|TWO_SIDED|95.0|0.32|1.43||0.05 a priori threshold for statistical significance.|Poisson regression with robust SEs||TAU is the reference group.|Null hypothesis: No difference between arms in number of participants who tested positive for stimulants at week 12.||1.43|0.32|0.30
72541400|NCT00386100|144612691|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.5|||<|0.0001|TWO_SIDED|95.0|-0.69|-0.3||No adjustment for multiple comparisons|Repeated measures analysis|Repeated measures analysis with terms for baseline, region, treatment, gender, time, and treatment by time interaction|AVM mean change from baseline minus MET mean change from baseline based on repeated measures analysis model|||-0.30|-0.69|<0.0001
72541401|NCT00386100|144612692|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.18||||0.0046|TWO_SIDED|95.0|1.18|2.46||Hb1AC \<= 6.5%|Regression, Logistic|Logistic reggression with terms for treatment, region, gender, and baseline Hb1AC with LOCF from Week 32.|Odds of having an HbA1c \<= 6.5% at Week 80 on Avandamet compared to Metformin.|||2.46|1.18|0.0046
72541402|NCT00386100|144612692|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.59|||<|0.0001|TWO_SIDED|95.0|1.75|3.81||Hb1AC \< 7%|Regression, Logistic|Logistic reggression with terms for treatment, region, gender, and baseline Hb1AC with LOCF from Week 32|Odds of having an HbA1c \<7% at Week 80 on Avandamet compared to Metformin|||3.81|1.75|<0.0001
72541403|NCT00386100|144612693|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.15|||<|0.0001||95.0|-1.54|-0.77|||Repeated measures analysis|Terms for baseline, region, treatment, pre-screening Hb1Ac strata, gender, time, and treatment by time interaction|AVM mean change from baseline minus MET mean change from baseline based on repeated measures analysis model|||-0.77|-1.54|<0.0001
72409973|NCT03779997|144328309|SUPERIORITY||Median Difference (Final Values)|0.02|STANDARD_DEVIATION|0.07||0.91|TWO_SIDED|95.0|-0.29|0.32||0.05 a priori threshold for statistical significance|t-test, 2 sided||TAU is the reference group|Null hypothesis: No difference between arms in mean treatment satisfaction scores||0.32|-0.29|0.91
72627812|NCT00565409|144783961|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.05||||0.9599|TWO_SIDED|95.0|0.6|1.7||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 56||1.7|0.6|0.9599
72409974|NCT02312310|144328314|SUPERIORITY|Test of trend across doses.||||||0.393|||||||Mixed Models Analysis|Change in outcome from baseline to 12 weeks tested using mixed effects models controlling for baseline measures, treatment, sex, age, and education.|||The flavanol effect on the change in each outcome from baseline to 12 weeks was tested using linear mixed effects models controlling for the respective baseline measures, four categories of treatment, sex, age, and education. Regression adjusted mean within-group tests of change were estimated and tested for statistical significance from the model. The primary test used for assessing the treatment effect was the linear trend contrast from the model across: placebo, low, medium and high dose. The model for cognitive measures incorporated additional outcome measurement times at 4 weeks and 20 weeks and included categorical time (4, 12, 20 weeks) as a predictor as well as a treatment (4 category) by time interaction, and a random intercept to control for repeated measures within individuals (results for 4 and 20 weeks not presented).|||.393
72409975|NCT01168999|144328319|SUPERIORITY_OR_OTHER||||||<|0.01||95.0|||||Chi-squared|||||||<0.01
72409976|NCT01168999|144328320|SUPERIORITY_OR_OTHER|||||||0.01||95.0|||||Chi-squared|||||||0.01
72409977|NCT01168999|144328321|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||Repeated Measure ANOVA|||||||>0.05
72409978|NCT01168999|144328322|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||Repeated Measure ANOVA|||||||>0.05
72409979|NCT01168999|144328323|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||Repeated Measure ANOVA|||||||0.05
72409980|NCT01168999|144328324|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||Repeated Measure ANOVA|||||||>0.05
72541404|NCT00386100|144612694|SUPERIORITY_OR_OTHER||Median Difference (Net)|-1.07|||<|0.001|TWO_SIDED|95.0|-1.425|-0.71||No adjustment for multiple comparisons|ANCOVA|Terms for treatment, region, gender, pre-screening Hb1Ac strata, and baseline with LOCF from Week 32 for withdrawn participants or missing values|AVM mean change from baseline minus MET mean change from baseline based on ANCOVA model|||-0.710|-1.425|<0.001
72541405|NCT00386100|144612695|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.47|||<|0.0001|TWO_SIDED|95.0|2.94|6.81||FPG \<=6.1 mmol/l|Regression, Logistic|Terms for treatment, region, gender, pre-screening Hb1Ac strata, and baseline with LOCF from Week 32.|Odds of having an FPG \<=6.1 mmol/l at Week 80 on Avandamet compared to Metformin|||6.81|2.94|<0.0001
72541406|NCT00386100|144612695|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.33|||<|0.0001|TWO_SIDED|95.0|2.25|4.92||FPG \<=7 mmol/l|Regression, Logistic|Terms for treatment, region, gender, pre-screening Hb1Ac, and baseline with LOCF from Week 32.|Odds of having an FPG \<=7 mmol/l at Week 80 on Avandamet compared to Metformin|||4.92|2.25|<0.0001
72541407|NCT00386100|144612696|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.58|||<|0.0001|TWO_SIDED|95.0|0.45|0.74|||Regression, Cox|Cox proportional hazard regression with terms for treatment, region, baseline Hb1Ac strata, and gender||||0.74|0.45|<0.0001
72541408|NCT00386100|144612697|SUPERIORITY_OR_OTHER||Percent difference from metformin|5.97||||0.0006|TWO_SIDED|95.0|2.522|9.526||Total cholesterol. No adjustment for multiple comparisons. Log transformed|ANCOVA|ANCOVA with log (value) minus log (baseline \[BL\]) as dependent variable. Terms for treatment, region, gender, pre-screening HbA1c strata, and log (BL)||||9.526|2.522|0.0006
72541409|NCT00386100|144612697|SUPERIORITY_OR_OTHER||Percent difference from metformin|8.71||||0.056|TWO_SIDED|95.0|2.486|15.304||LDL cholesterol. No adjustment for multiple comparisons. Log transformed|ANCOVA|ANCOVA with log (value) minus log (baseline \[BL\]) as dependent variable. Terms for treatment, region, gender, pre-screening HbA1c strata, and log (BL)||||15.304|2.486|0.056
72541410|NCT00386100|144612697|SUPERIORITY_OR_OTHER||Percent difference from metformin|2.58||||0.072|TWO_SIDED|95.0|-0.232|5.47||HDL cholesterol. No adjustment for multiple comparison. Log transformed.|ANCOVA|ANCOVA with log (value) minus log (baseline \[BL\]) as dependent variable. Terms for treatment, region, gender, pre-screening HbA1c strata, and log (BL)||||5.470|-0.232|0.072
72541411|NCT00386100|144612697|SUPERIORITY_OR_OTHER||Percent difference from metformin|0.743||||0.835|TWO_SIDED|95.0|-6.056|8.035||Triglycerides. No adjustment for multiple comparisons. Log transformed.|ANCOVA|ANCOVA with log (value) minus log (baseline \[BL\]) as dependent variable. Terms for treatment, region, gender, pre-screening HbA1c strata, and log (BL)||||8.035|-6.056|0.835
72541412|NCT00386100|144612698|SUPERIORITY_OR_OTHER||Percent difference from metformin|102.24|||<|0.0001|TWO_SIDED|95.0|79.23|128.19||No adjustment for multiple comparisons. Log transformed.|ANCOVA|ANCOVA with log (value) minus log (baseline \[BL\]) as dependent variable. Terms for treatment, region, gender, pre-screening HbA1c strata, and log (BL)||||128.19|79.23|<0.0001
72541413|NCT00386100|144612699|SUPERIORITY_OR_OTHER||Percent difference from metformin|-8.2||||0.138|TWO_SIDED|95.0|-18.04|2.82||No adjustment for multiple comparisons. Log transformed.|ANCOVA|ANCOVA with log (value) minus log (baseline \[BL\]) as dependent variable. Terms for treatment, region, gender, pre-screening HbA1c strata, and log (BL)||||2.82|-18.04|0.1380
72541414|NCT00386100|144612700|SUPERIORITY_OR_OTHER||Percent difference from metformin|-11.308||||0.0342|TWO_SIDED|95.0|-20.617|-0.899||No adjustment for multiple comparisons. Log transformed.|ANCOVA|ANCOVA with log (value) minus log (baseline \[BL\]) as dependent variable. Terms for treatment, region, gender, pre-screening HbA1c strata, and log (BL)||||-0.899|-20.617|0.0342
72541415|NCT00386100|144612701|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-33.7||||0.0042|TWO_SIDED|95.0|-56.666|-0.99||No adjustment for multiple comparisons.|ANCOVA|ANCOVA with terms for treatment, region, gender, pre-screening HbA1c strata, and baseline.|AVM mean change from baseline minus MET mean change from baseline based on ANCOVA model|||-0.99|-56.666|0.0042
72541416|NCT00386100|144612702|SUPERIORITY_OR_OTHER||Median Difference (Net)|-0.229||||0.0006|TWO_SIDED|95.0|-0.359|-0.099||No adjustment for multiple comparisons.|ANCOVA|ANCOVA with terms for treatment, region, gender, pre-screening HbA1c strata, and baseline|AVM mean change from baseline minus MET mean change from baseline based on ANCOVA model|||-0.099|-0.359|0.0006
72541417|NCT00386100|144612703|SUPERIORITY_OR_OTHER||Percent difference from metformin|2.4||||0.7148|TWO_SIDED|95.0|-9.87|16.34||HOMA-B. Log transformed.|ANCOVA|ANCOVA with log (value) minus log (baseline \[BL\]) as dependent variable. Terms for treatment, region, gender, pre-screening HbA1c strata, and log (BL)||||16.34|-9.87|0.7148
72541418|NCT00386100|144612703|SUPERIORITY_OR_OTHER||percent difference from metformin|31.14|||<|0.001|TWO_SIDED|95.0|14.82|49.78||HOMA-S. Log transformed.|ANCOVA|ANCOVA with log (value) minus log (baseline \[BL\]) as dependent variable. Terms for treatment, region, gender, pre-screening HbA1c strata, and log (BL)||||49.78|14.82|<0.001
72541419|NCT00386100|144612704|SUPERIORITY_OR_OTHER||Mean Difference (Net)|80.85||||0.319|TWO_SIDED|95.0|-79.035|240.744|||Repeated measures analysis|Repeated measures analysis with terms for baseline, region, treatment, gender, pre-screening Hb1AC, time, and treatment by time interaction||||240.744|-79.035|0.319
72541420|NCT00386100|144612706|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.2||||0.0012|TWO_SIDED|95.0|-3.5|-0.9||Overall population, Week 80. No adjustment for multiple comparisons. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||-0.9|-3.5|0.0012
72541421|NCT00386100|144612706|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.6||||0.0031|TWO_SIDED|95.0|-2.7|-0.6||Overall population, Week 56. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||-0.6|-2.7|0.0031
72541422|NCT00386100|144612706|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.1||||0.0308|TWO_SIDED|95.0|-2.0|-0.1||Overall population, Week 20. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||-0.1|-2.0|0.0308
72541423|NCT00386100|144612706|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.7||||0.0954|TWO_SIDED|95.0|-3.7|0.3||Male population, Week 80. No adjustment for multiple comparisons. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||0.3|-3.7|0.0954
72541424|NCT00386100|144612706|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.9||||0.0015|TWO_SIDED|95.0|-4.7|-1.2||Female population, Week 80. No adjustment for multiple comparisons. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||-1.2|-4.7|0.0015
72541425|NCT00386100|144612706|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.3||||0.0045|TWO_SIDED|95.0|-3.9|-0.7||Female population, Week 56. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||-0.7|-3.9|0.0045
72541426|NCT00386100|144612706|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.2||||0.0005|TWO_SIDED|95.0|-3.3|-1.0||Female population, Week 20. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||-1.0|-3.3|0.0005
72541427|NCT00386100|144612706|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.7||||0.2363|TWO_SIDED|95.0|-4.6|1.2||Premenopausal female population, Week 80. No adjustment for multiple comparisons. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||1.2|-4.6|0.2363
72541428|NCT00386100|144612706|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.3||||0.0161|TWO_SIDED|95.0|-5.9|-0.6||Postmenopausal female population, Week 80. No adjustment for multiple comparisons. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||-0.6|-5.9|0.0161
72541429|NCT00386100|144612706|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.6||||0.0338|TWO_SIDED|95.0|-4.9|-0.2||Postmenopausal female population, Week 56. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||-0.2|-4.9|0.0338
72541430|NCT00386100|144612706|SUPERIORITY_OR_OTHER||Median Difference (Net)|-2.6||||0.002|TWO_SIDED|95.0|-4.1|-1.0||Postmenopausal female population, Week 20. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||-1.0|-4.1|0.0020
72541431|NCT00386100|144612707|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.5||||0.0005|TWO_SIDED|95.0|-2.3|-0.7||Overall population, Week 80. No adjustment for multiple comparisons. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||-0.7|-2.3|0.0005
72541432|NCT00386100|144612707|SUPERIORITY_OR_OTHER||Median Difference (Net)|-1.0||||0.011|TWO_SIDED|95.0|-1.7|-0.2||Overall population, Week 56. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||-0.2|-1.7|0.0110
72541433|NCT00386100|144612707|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.6||||0.0618|TWO_SIDED|95.0|-1.1|0.0||Overall population, Week 20. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||0.0|-1.1|0.0618
72409981|NCT03264157|144328332|NON_INFERIORITY|The null hypothesis is p-p0 ≤ -0.1. The alternative hypothesis is p-p0 \> -0.1, where p is the proportion of subjects with anti-rabies titer of \>0.5 IU/mL at Day 14 in subjects receiving BPL HRIG + vaccine and p0 is the proportion receiving comparator HRIG + vaccine. We reject the null hypothesis at the one-sided 0.025 significance level, and conclude that p-p0 \> -0.1, if the lower bound of an exact 95% binomial confidence interval exceeds -0.1.|lower 95% CI|-0.05||||0.0006|ONE_SIDED|95.0|-0.05|||The threshold for this test is \<=0.025.|Farrington and Manning test||||||-0.05|0.0006
72541434|NCT00386100|144612707|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.3||||0.011|TWO_SIDED|95.0|-2.3|-0.3||Male population, Week 80. No adjustment for multiple comparisons. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||-0.3|-2.3|0.0110
72541435|NCT00386100|144612707|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.0||||0.0272|TWO_SIDED|95.0|-1.9|-0.1||Male population, Week 56. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||-0.1|-1.9|0.0272
72541436|NCT00386100|144612707|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.8||||0.0337|TWO_SIDED|95.0|-1.6|-0.1||Male population, Week 20. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||-0.1|-1.6|0.0337
72541437|NCT00386100|144612707|SUPERIORITY_OR_OTHER||Median Difference (Net)|-1.7||||0.0152|TWO_SIDED|95.0|-3.1|-0.3||Female population, Week 80. No adjustment for multiple comparisons. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||-0.3|-3.1|0.0152
72541438|NCT00386100|144612707|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.2||||0.057|TWO_SIDED|95.0|-2.4|0.0||Female population, Week 56. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||0.0|-2.4|0.0570
72541439|NCT00386100|144612707|SUPERIORITY_OR_OTHER||Median Difference (Net)|-2.2||||0.0296|TWO_SIDED|95.0|-4.3|-0.2||Premenopausal female population, Week 80. No adjustment for multiple comparisons. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||-0.2|-4.3|0.0296
72541440|NCT00386100|144612707|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.4||||0.0155|TWO_SIDED|95.0|-4.4|-0.5||Premenopausal female population, Week 56. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||-0.5|-4.4|0.0155
72541441|NCT00386100|144612707|SUPERIORITY_OR_OTHER||Median Difference (Net)|-0.4||||0.587|TWO_SIDED|95.0|-1.7|1.0||Premenopausal female population, Week 20. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||1.0|-1.7|0.5870
72541442|NCT00386100|144612707|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.5||||0.1854|TWO_SIDED|95.0|-3.6|0.7||Postmenopausal female population, Week 80. No adjustment for multiple comparisons. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||0.7|-3.6|0.1854
72541443|NCT00386100|144612708|SUPERIORITY_OR_OTHER||Median Difference (Net)|-1.9||||0.0038|TWO_SIDED|95.0|-3.2|-0.6||Overall population, Week 80. No adjustment for multiple comparisons. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||-0.6|-3.2|0.0038
72541444|NCT00386100|144612708|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.5||||0.0134|TWO_SIDED|95.0|-2.7|-0.3||Overall population, Week 56. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||-0.3|-2.7|0.0134
72541445|NCT00386100|144612708|SUPERIORITY_OR_OTHER||Median Difference (Net)|-0.7||||0.0967|TWO_SIDED|95.0|-1.5|0.1||Overall population, Week 20. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||0.1|-1.5|0.0967
72541446|NCT00386100|144612708|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.5||||0.0512|TWO_SIDED|95.0|-3.0|0.0||Male population, Week 80. No adjustment for multiple comparisons. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||0.0|-3.0|0.0512
72541447|NCT00386100|144612708|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.4||||0.033|TWO_SIDED|95.0|-4.6|-0.2||Female population, Week 80. No adjustment for multiple comparisons. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||-0.2|-4.6|0.0330
72541448|NCT00386100|144612708|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.8||||0.0547|TWO_SIDED|95.0|-3.7|0.0||Female population, Week 56. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||0.0|-3.7|0.0547
72541449|NCT00386100|144612708|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.1||||0.0613|TWO_SIDED|95.0|-6.3|0.2||Premenopausal female population, Week 80. No adjustment for multiple comparisons. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||0.2|-6.3|0.0613
72541450|NCT00386100|144612708|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.5||||0.1369|TWO_SIDED|95.0|-3.9|1.7||Postmenopausal female population, Week 80. No adjustment for multiple comparisons. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||1.7|-3.9|0.1369
72541451|NCT00386100|144612709|SUPERIORITY_OR_OTHER||Median Difference (Net)|-0.7||||0.126|TWO_SIDED|95.0|-1.7|0.2||Overall population, Week 80. No adjustment for multiple comparisons. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||0.2|-1.7|0.1260
72541452|NCT00386100|144612709|SUPERIORITY_OR_OTHER||Median Difference (Net)|-0.7||||0.3117|TWO_SIDED|95.0|-2.2|0.7||Male population, Week 80. No adjustment for multiple comparisons. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||0.7|-2.2|0.3117
72541453|NCT00386100|144612709|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.9||||0.1776|TWO_SIDED|95.0|-2.2|0.4||Female population, Week 80. No adjustment for multiple comparisons. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||0.4|-2.2|0.1776
72541454|NCT00386100|144612709|SUPERIORITY_OR_OTHER||Median Difference (Net)|-1.2||||0.2259|TWO_SIDED|95.0|-3.2|0.8||Premenopausal female population, Week 80. No adjustment for multiple comparisons. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||0.8|-3.2|0.2259
72627813|NCT00565409|144783961|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.98|||<|0.0001|TWO_SIDED|95.0|1.9|4.6||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 56||4.6|1.9|<0.0001
72627814|NCT00565409|144783961|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.59|||<|0.0001|TWO_SIDED|95.0|2.3|5.7||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 64||5.7|2.3|<0.0001
72627815|NCT00565409|144783961|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.23||||0.4509|TWO_SIDED|95.0|0.8|2.0||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 64||2.0|0.8|0.4509
72409982|NCT03264157|144328333|NON_INFERIORITY|The prespecified non inferiority margin was 20%. The lower bound of the 95% CI required should be greater than 0.8 to conclude non-inferiority.|lower 95% CI|0.74|||||TWO_SIDED|95.0|0.74|0.94||||||||0.94|0.74|
72541455|NCT00386100|144612709|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.9||||0.384|TWO_SIDED|95.0|-2.8|1.1||postmenopausal female population, Week 80. No adjustment for multiple comparisons. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||1.1|-2.8|0.3840
72409983|NCT03264157|144328334|SUPERIORITY||95% CI|0.97|||||TWO_SIDED||||||||Data analyzed as log normal. The value presented is the untransformed value of the difference between means.|||||
72541456|NCT00386100|144612710|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.4||||0.6102|TWO_SIDED|95.0|-1.9|1.1||Overall population, Week 80. No adjustment for multiple comparisons. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||1.1|-1.9|0.6102
72541457|NCT00386100|144612710|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.9||||0.3445|TWO_SIDED|95.0|-2.9|1.0||Male population, Week 80. No adjustment for multiple comparisons. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||1.0|-2.9|0.3445
72575894|NCT04040192|144677932|OTHER||Median Difference (Final Values)|-0.5||||0.0042|TWO_SIDED|95.0|-1.0|0.0||p-value was estimated by Wilcoxon rank sum test stratified by age group, duration of the BID treatment in OL period, and ISGA score at randomization.|Wilcoxon (Mann-Whitney)||Median difference and 95%CI were estimated using Hodges-Lehmann method.|||0.00|-1.00|0.0042
72575895|NCT04040192|144677933|OTHER|||||||0.6815||||||p-value was estimated by the log-rank test, stratified by age group, duration of the BID treatment in OL period, and ISGA score at randomization.|Log Rank|||Baseline PP NRS \>=3 and \>=3 point reduction in PP NRS||||0.6815
72575896|NCT04040192|144677933|OTHER|||||||0.1518||||||p-value was estimated by the log-rank test, stratified by age group, duration of the BID treatment in OL period, and ISGA score at randomization.|Log Rank|||Baseline PP NRS \>=4 and \>=4 point reduction in PP NRS||||0.1518
72627816|NCT00565409|144783961|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.96|||<|0.0001|TWO_SIDED|95.0|1.9|4.6||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 64||4.6|1.9|<0.0001
72627817|NCT00565409|144783961|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.28|||<|0.0001|TWO_SIDED|95.0|2.6|7.0||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 72||7.0|2.6|<0.0001
72575897|NCT04040192|144677934|OTHER|||||||0.1933||||||p-value was estimated by the log-rank test, stratified by age group, duration of the BID treatment in OL period, and ISGA score at randomization|Log Rank|||||||0.1933
72627818|NCT00565409|144783961|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.2||||0.3037|TWO_SIDED|95.0|0.7|2.0||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 72||2.0|0.7|0.3037
72409984|NCT03264157|144328335|NON_INFERIORITY|The same methodology was used as the primary endpoint for each visit. The statistical analysis is presenting the Day 14 data.|lower 95% CI|-0.05||||0.0006|TWO_SIDED|95.0|-0.05|0.1|||Farrington and Manning test|||||0.10|-0.05|0.0006
72575898|NCT04040192|144677935|OTHER|p-value was estimated by the log-rank test, stratified by age group, duration of the BID treatment in OL period, and ISGA score at randomization||||||0.3778|||||||Log Rank|||Baseline ORIS Scale \>=3 and \>=3 point reduction||||0.3778
72575899|NCT04040192|144677935|OTHER|p-value was estimated by the log-rank test, stratified by age group, duration of the BID treatment in OL period, and ISGA score at randomization||||||0.487|||||||Log Rank|||Baseline ORIS Scale \>=4 and \>=4 point reduction||||0.4870
72575900|NCT04040192|144677936|OTHER|||||||0.1159||||||p-value was estimated by the log-rank test, stratified by age group, duration of the BID treatment in OL period, and ISGA score at randomization.|Log Rank|||||||0.1159
72575901|NCT04040192|144677937|OTHER|||||||0.6973||||||p-value was estimated by the log-rank test, stratified by age group, duration of the BID treatment in OL period, and ISGA score at randomization.|Log Rank|||DLQI for participants \>=16 years of age||||0.6973
72627819|NCT00565409|144783961|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.27|||<|0.0001|TWO_SIDED|95.0|2.1|5.1||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 72||5.1|2.1|<0.0001
72409985|NCT03264157|144328336|NON_INFERIORITY|The same methodology was used as the primary endpoint for each visit. The statistical analysis is presenting the Day 14 data.|lower 95% CI|0.0||||0|TWO_SIDED|95.0|0.0|0.0|||Farrington and Manning test||For Day 14, all subjects achieved the endpoint (RVNA titer \> LLOQ). Since the statistic to measure the performance is a proportion, the proportion is 1 and no variance is calculable.|||0|0|0
72627820|NCT00565409|144783961|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.41|||<|0.0001|TWO_SIDED|95.0|2.7|7.2||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 80||7.2|2.7|<0.0001
72409986|NCT03698773|144328338|SUPERIORITY|||||||0.16|||||||Wilcoxon (Mann-Whitney)|||||||0.16
72541458|NCT00386100|144612710|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0||||0.9735|TWO_SIDED|95.0|-2.4|2.3||Female population, Week 80. No adjustment for multiple comparisons. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||2.3|-2.4|0.9735
72541459|NCT00386100|144612710|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.4||||0.4861|TWO_SIDED|95.0|-5.8|2.9||Premenopausal female population, Week 80. No adjustment for multiple comparisons. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||2.9|-5.8|0.4861
72541460|NCT00386100|144612710|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.3||||0.877|TWO_SIDED|95.0|-3.5|4.0||Postmenopausal female population, Week 80. No adjustment for multiple comparisons. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||4.0|-3.5|0.8770
72541461|NCT00386100|144612711|SUPERIORITY_OR_OTHER||Median Difference (Net)|-0.2||||0.7015|TWO_SIDED|95.0|-1.5|1.0||Overall population, Week 80. No adjustment for multiple comparisons. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||1.0|-1.5|0.7015
72409987|NCT03698773|144328339|SUPERIORITY||||||>|0.99|||||||Fisher Exact|||||||>0.99
72409988|NCT05074433|144328340|SUPERIORITY||Hazard Ratio (HR)|0.563|||||TWO_SIDED|95.0|0.093|3.393|||Cox proportional hazard model|||||3.393|0.093|
72409989|NCT05074433|144328340|SUPERIORITY||Hazard Ratio (HR)|0.46|||||TWO_SIDED|95.0|0.072|2.929|||Cox proportional hazard model|||||2.929|0.072|
72409990|NCT05074433|144328340|SUPERIORITY||Cox Proportional Hazard|0.609|||||TWO_SIDED|95.0|0.101|3.668|||Cox proportional hazard model|||||3.668|0.101|
72409991|NCT02822794|144328370|SUPERIORITY||||||<|0.001|||||||Binomial test|P-value is obtained from the 2-sided exact 1-sample binomial test for the superiority of SOF/VEL+RBV 12 Weeks (GT1) over the performance goal of 50%.||||||<0.001
72541462|NCT00386100|144612711|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.2||||0.6767|TWO_SIDED|95.0|-0.7|1.0||Male population, Week 80. No adjustment for multiple comparisons. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||1.0|-0.7|0.6767
72541463|NCT00386100|144612711|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.0||||0.4199|TWO_SIDED|95.0|-3.4|1.5||Female population, Week 80. No adjustment for multiple comparisons. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||1.5|-3.4|0.4199
72541464|NCT00386100|144612711|SUPERIORITY_OR_OTHER||Median Difference (Net)|-5.5||||0.2526|TWO_SIDED|95.0|-16.4|5.4||Premenopausal female population, Week 80. No adjustment for multiple comparisons. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||5.4|-16.4|0.2526
72541465|NCT00386100|144612711|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.5||||0.4153|TWO_SIDED|95.0|-1.8|0.8||postmenopausal female population, Week 80. No adjustment for multiple comparisons. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||0.8|-1.8|0.4153
72541466|NCT00386100|144612712|SUPERIORITY_OR_OTHER||Percent difference from metformin|0.168||||0.7895|TWO_SIDED|95.0|-1.066|1.417||Overall population, Week 80. Log transformed. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline.||||1.417|-1.066|0.7895
72541467|NCT00386100|144612712|SUPERIORITY_OR_OTHER||Percent difference from metformin|0.745||||0.4155|TWO_SIDED|95.0|-1.064|2.587||Males, Week 80. Log transformed. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline.||||2.587|-1.064|0.4155
72541468|NCT00386100|144612712|SUPERIORITY_OR_OTHER||Percent difference from metformin|-0.452||||0.6223|TWO_SIDED|95.0|-2.253|1.382||Females, Week 80. Log transformed. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline.||||1.382|-2.253|0.6223
72541469|NCT00386100|144612712|SUPERIORITY_OR_OTHER||Percent difference from metformin|-0.638||||0.5908|TWO_SIDED|95.0|-3.043|1.826||Premenopausal females, Week 80. Log transformed. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline.||||1.826|-3.043|0.5908
72541470|NCT00386100|144612712|SUPERIORITY_OR_OTHER||Percent difference from metformin|-0.155||||0.9154|TWO_SIDED|95.0|-3.037|2.814||Postmenopausal females, Week 80. Log transformed. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline.||||2.814|-3.037|0.9154
72541471|NCT00386100|144612713|SUPERIORITY_OR_OTHER||Percent difference from metformin|1.467||||0.8682|TWO_SIDED|95.0|-14.785|20.818||Overall population, Week 80. Log transformed.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||20.818|-14.785|0.8682
72541472|NCT00386100|144612713|SUPERIORITY_OR_OTHER||Percent difference from metformin|0.328||||0.974|TWO_SIDED|95.0|-18.308|23.214||Males, Week 80. Log transformed.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline.||||23.214|-18.308|0.9740
72541473|NCT00386100|144612713|SUPERIORITY_OR_OTHER||Percent difference from metformin|2.986||||0.8378|TWO_SIDED|95.0|-22.997|37.735||Females, Week 80. Log transformed.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline.||||37.735|-22.997|0.8378
72575902|NCT04040192|144677937|OTHER|||||||0.7456||||||p-value was estimated by the log-rank test, stratified by age group, duration of the BID treatment in OL period, and ISGA score at randomization.|Log Rank|||Children's DLQI: participants 4-\<16 yrs of age||||0.7456
72575903|NCT04040192|144677938|OTHER|||||||0.0513||||||p-value was estimated by the log-rank test, stratified by age group, duration of the BID treatment in OL period, and ISGA score at randomization.|Log Rank|||POEM||||0.0513
72575904|NCT04040192|144677938|OTHER|||||||0.0217||||||p-value was estimated by the log-rank test, stratified by age group, duration of the BID treatment in OL period, and ISGA score at randomization.|Log Rank|||Proxy POEM||||0.0217
72575905|NCT03207243|144678031|OTHER||Median Rate Ratio|0.82|||||TWO_SIDED|95.0|0.66|0.99|||||Median rate ratio (Placebo - GSK3772847) and its 95% Credible Interval has been presented|||0.99|0.66|
72575906|NCT03207243|144678036|OTHER||Median Rate Ratio|0.71|||||TWO_SIDED|95.0|0.44|1.01|||||Median rate ratio (Placebo - GSK3772847) and its 95% Credible Interval has been presented|||1.01|0.44|
72575907|NCT03207243|144678037|OTHER|||||||0.044|||||||Log Rank|||||||0.044
72627821|NCT00565409|144783961|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.13||||0.6076|TWO_SIDED|95.0|0.7|1.9||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 80||1.9|0.7|0.6076
72575908|NCT03207243|144678081|OTHER||Percent change|-93.4|||<|0.001|TWO_SIDED|95.0|-94.9|-91.7||Week 4|mixed model repeated measures analysis|||||-91.7|-94.9|<0.001
72575909|NCT03207243|144678081|OTHER||Percent change|-92.9|||<|0.001|TWO_SIDED|95.0|-94.8|-90.3||Week 8|mixed model repeated measures analysis|||||-90.3|-94.8|<0.001
72575910|NCT03207243|144678081|OTHER||Percent change|-93.2|||<|0.001|TWO_SIDED|95.0|-95.4|-90.0||Week 12|mixed model repeated measures analysis|||||-90.0|-95.4|<0.001
72575911|NCT03207243|144678081|OTHER||Percent change|-93.3|||<|0.001|TWO_SIDED|95.0|-95.3|-90.4||Week 16|mixed model repeated measures analysis|||||-90.4|-95.3|<0.001
72575912|NCT03207243|144678082|OTHER||Percent change|2300.4|||<|0.001|TWO_SIDED|95.0|1833.9|2879.3||Week 4|mixed model repeated measures analysis|||||2879.3|1833.9|<0.001
72627822|NCT00565409|144783961|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.8|||<|0.0001|TWO_SIDED|95.0|2.4|6.0||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 80||6.0|2.4|<0.0001
72575913|NCT03207243|144678082|OTHER||Percent change|2507.7|||<|0.001|TWO_SIDED|95.0|1924.2|3259.4||Week 8|mixed model repeated measures analysis|||||3259.4|1924.2|<0.001
72575914|NCT03207243|144678082|OTHER||Percent change|2162.2|||<|0.001|TWO_SIDED|95.0|1489.1|3120.3||Week 12|mixed model repeated measures analysis|||||3120.3|1489.1|<0.001
72575915|NCT03207243|144678082|OTHER||Percent change|2663.0|||<|0.001|TWO_SIDED|95.0|1994.6|3544.8||Week 16|mixed model repeated measures analysis|||||3544.8|1994.6|<0.001
72575916|NCT02309138|144678090|SUPERIORITY||Risk Ratio (RR)|0.903||||0.668|TWO_SIDED|97.5|0.538|1.516||Each co-primary hypothesis was tested at the 2.5% significance level.|Regression, Logistic|In the ITT, logistic regression was used to quantify the probability of large-for-gestational age as a function of the study arm and clinic type.|A relative risk \< 1 represents a benefit in the direction of the IADPSG group, while a value \> 1 represents a benefit towards the CC group.|Co-primary hypotheses #1: women diagnosed using the IADPSG criteria will have lower rates of large-for-gestational age infants compared to those diagnosed using the Carpenter-Coustan criteria.||1.516|0.538|0.668
72575917|NCT02309138|144678090|SUPERIORITY||Risk Ratio (RR)|0.853||||0.853|TWO_SIDED|97.5|0.493|1.475||Each co-primary hypothesis was tested at the 2.5% significance level.|Regression, Logistic|In the ITT, logistic regression was used to quantify the probability of large-for-gestational age as a function of the study arm and clinic type.||"Co-primary hypothesis #2: women classified as no gestational diabetes by the IADPSG criteria will have lower rates of large-for-gestational age infants compared to those classified in the Carpenter-Coustan criteria."||1.475|0.493|0.853
72575918|NCT02309138|144678091|SUPERIORITY||Risk Ratio (RR)|1.046||||0.6669|TWO_SIDED|95.0|0.847|1.291|||Regression, Logistic|||||1.291|0.847|0.6669
72575919|NCT02309138|144678091|SUPERIORITY||Risk Ratio (RR)|1.033||||0.8394|TWO_SIDED|95.0|0.816|1.307|||Regression, Logistic|||||1.307|0.816|0.8394
72575920|NCT02309138|144678092|SUPERIORITY||Risk Ratio (RR)|0.987||||0.9335|TWO_SIDED|95.0|0.74|1.318|||Regression, Logistic|||||1.318|0.740|0.9335
72575921|NCT02309138|144678092|SUPERIORITY||Risk Ratio (RR)|1.022||||0.926|TWO_SIDED|95.0|0.742|1.407|||Regression, Logistic|||||1.407|0.742|0.9260
72575922|NCT02309138|144678093|SUPERIORITY||Risk Ratio (RR)|1.4||||0.0322|TWO_SIDED|95.0|1.027|1.909|||Regression, Logistic|||||1.909|1.027|0.0322
72575923|NCT02309138|144678093|SUPERIORITY||Risk Ratio (RR)|1.233||||0.2643|TWO_SIDED|95.0|0.864|1.76|||Regression, Logistic|||||1.760|0.864|0.2643
72575924|NCT01590797|144678137|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.34|||<|0.001|TWO_SIDED|95.0|-0.5|-0.19|||Robust Regression|Robust regression using M-estimation with terms for treatment and the metformin stratum and type of insulin, and baseline A1C (%) as a covariate.||||-0.19|-0.50|<0.001
72575925|NCT01590797|144678138|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.38||||0.002|TWO_SIDED|95.0|-0.61|-0.14|||Robust Regression|Robust regression using M-estimation with terms for treatment and type of insulin, and baseline A1C (%) as a covariate.||||-0.14|-0.61|0.002
72575926|NCT01590797|144678139|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-26.5|||<|0.001|TWO_SIDED|95.0|-38.4|-14.7|||ANCOVA|ANCOVA model with terms for treatment and the metformin stratum and type of insulin, and baseline 2-hr Post- Meal Glucose (mg/dL) as a covariate.||||-14.7|-38.4|<0.001
72575927|NCT01559389|144678146|SUPERIORITY||Mean Difference (Final Values)|-0.51|STANDARD_DEVIATION|2.5||0.16|TWO_SIDED|95.0|-1.23|0.21||P-values less than 0.05 were considered statistically significant.|t-test, 2 sided|The method was a paired t-test||The null hypothesis is that there is no difference in the overall GRISS score between females with UUI and their male partners||0.21|-1.23|.16
72409992|NCT02822794|144328370|SUPERIORITY||||||<|0.001|||||||Binomial test|P-value is obtained from the 2-sided exact 1-sample binomial test for the superiority of SOF/VEL +RBV 24 Weeks (GT1) over the performance goal of 50%.||||||<0.001
72575928|NCT01559389|144678147|SUPERIORITY||z-score|2.97||||0.003|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|Exact test|The z-score is a standardized Wilcoxon statistic. In this study, z-scores with an absolute value exceeding 1.96 indicate a significant difference in the GRISS change score between responders and non-responders of solifenacin treatment|The null hypothesis is that there is no difference in the overall GRISS change score between those who respond and do not respond to treatment with solifenacin.||||.003
72575929|NCT01559389|144678148|SUPERIORITY||z-score|0.89||||0.37|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||The z-score is a standardized Wilcoxon statistic. In this study, z-scores with an absolute value exceeding 1.96 indicate a significant difference in the GRISS change score between the two groups|The null hypothesis is that there is no difference in the overall GRISS change score between male partners of female participants who respond to solifenacin and male partners of female participants who do not respond to solifenacin||||.37
72575930|NCT01346293|144678161|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority of DTaP-IPV was demonstrated if the lower limits of the 2-sided 95% Confidence intervals (CIs) of the difference (DTaP-IPV minus DAPTACEL® + IPOL®) in post-vaccination booster response rates for Anti-Pertussis toxoid antigen between groups were \> -10%.|Mean Difference (Final Values)|5.4|||||TWO_SIDED|95.0|0.7|10.2||||||Non-inferiority comparison of post-vaccination anti-pertussis booster response rates in the Per-protocol Analysis Set. The hypothesis was based on testing the difference between 2 proportion parameters.||10.2|0.7|
72576814|NCT00261443|144680655|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.29||||0.038|TWO_SIDED|95.0|-0.56|-0.02||Baseline: ANOVA model, controlling for treatment, mood stabilizer, and index mood episode. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 40 Comparison||-0.02|-0.56|0.038
72576815|NCT00261443|144680655|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.34||||0.015|TWO_SIDED|95.0|-0.62|-0.07||Baseline: ANOVA model, controlling for treatment, mood stabilizer, and index mood episode. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 44 Comparison||-0.07|-0.62|0.015
72409993|NCT01243944|144328399|SUPERIORITY_OR_OTHER||Odds Ratio, log|32.67|||<|0.0001|TWO_SIDED|95.0|5.04|1337.0|||Exact Cochran-Mantel-Haenszel|||||1337|5.04|< 0.0001
72541474|NCT00386100|144612713|SUPERIORITY_OR_OTHER||Percent difference from metformin|8.19||||0.7889|TWO_SIDED|95.0|-43.839|108.422||Pre-menopausal females, Week 80. Log transformed.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline.||||108.422|-43.839|0.7889
72541475|NCT00386100|144612713|SUPERIORITY_OR_OTHER||Percent difference from metformin|3.344||||0.88|TWO_SIDED|95.0|-34.853|63.935||Postmenopausal females, Week 80. Log transformed.|ANCOVA|.Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline.||||63.935|-34.853|0.8800
72541476|NCT00386100|144612714|SUPERIORITY_OR_OTHER||Percent difference from metformin|1.2168||||0.9069|TWO_SIDED|95.0|-17.6057|24.3392||Overall population, Week 80. Log transformed.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline.||||24.3392|-17.6057|0.9069
72541477|NCT00386100|144612714|SUPERIORITY_OR_OTHER||Percent difference from metformin|-10.1648||||0.5118|TWO_SIDED|95.0|-35.6298|25.3742||Males, Week 80. Log transformed.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline.||||25.3742|-35.6298|0.5118
72541478|NCT00386100|144612714|SUPERIORITY_OR_OTHER||Percent difference from metformin|8.8777||||0.5816|TWO_SIDED|95.0|-20.2636|48.6692||Females, Week 80. Log transformed.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline.||||48.6692|-20.2636|0.5816
72575931|NCT01346293|144678161|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority of DTaP-IPV was demonstrated if the lower limits of the 2-sided 95% CIs of the difference (DTaP-IPV minus DAPTACEL® + IPOL®) in post-vaccination booster response rates for Anti-Filamentous Haemagglutinin between groups were \> -10%.|Mean Difference (Final Values)|7.4|||||TWO_SIDED|95.0|2.5|21.5||||||Non-inferiority comparison of post-vaccination anti-pertussis booster response rates in the Per-protocol Analysis Set. The hypothesis was based on testing the difference between 2 proportion parameters.||21.5|2.5|
72575932|NCT01346293|144678161|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority of DTaP-IPV was demonstrated if the lower limits of the 2-sided 95% CIs of the difference (DTaP-IPV minus DAPTACEL® + IPOL®) in post-vaccination booster response rates for the Pertactin antigens between groups were \> -10%.|Mean Difference (Final Values)|3.7|||||TWO_SIDED|3.7|-0.2|7.9||||||Non-inferiority comparison of post-vaccination anti-pertussis booster response rates in the Per-protocol Analysis Set. The hypothesis was based on testing the difference between 2 proportion parameters.||7.9|-0.2|
72541479|NCT00386100|144612714|SUPERIORITY_OR_OTHER||Percent difference from metformin|-1.0031||||0.9587|TWO_SIDED|95.0|-35.928|52.959||Pre-menopausal females, Week 80. Log transformed.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline.||||52.9590|-35.9280|0.9587
72541480|NCT00386100|144612714|SUPERIORITY_OR_OTHER||Percent difference from metformin|4.7614||||0.8337|TWO_SIDED|95.0|-34.4741|67.4901||Postmenopausal females, Week 80. Log transformed.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline.||||67.4901|-34.4741|0.8337
72541481|NCT00386100|144612715|SUPERIORITY_OR_OTHER||Percent difference from metformin|7.527||||0.7041|TWO_SIDED|95.0|-26.773|57.892||Females, Week 80. Log transformed. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline.||||57.892|-26.773|0.7041
72541482|NCT00386100|144612715|SUPERIORITY_OR_OTHER||Percent difference from metformin|30.211||||0.6403|TWO_SIDED|95.0|-61.586|341.371||Pre-menopausal females, Week 80. Log transformed. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline.||||341.371|-61.586|0.6403
72541483|NCT00386100|144612715|SUPERIORITY_OR_OTHER||Percent difference from metformin|1.929||||0.8474|TWO_SIDED|95.0|-17.015|25.198||Postmenopausal females, Week 80. Log transformed. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|.Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline.||||25.198|-17.015|0.8474
72541484|NCT00386100|144612716|SUPERIORITY_OR_OTHER||Percent difference from metformin|5.7||||0.486|TWO_SIDED|95.0|-9.6|23.6||Overall, Week 80. Log transformed. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||23.6|-9.6|0.4860
72541485|NCT00386100|144612716|SUPERIORITY_OR_OTHER||Percent difference from metformin|12.3||||0.3791|TWO_SIDED|95.0|-13.7|46.1||Males, Week 80. Log transformed. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||46.1|-13.7|0.3791
72541486|NCT00386100|144612716|SUPERIORITY_OR_OTHER||Percent difference from metformin|4.0||||0.7065|TWO_SIDED|95.0|-15.3|27.6||Females, Week 80. Log transformed. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||27.6|-15.3|0.7065
72541487|NCT00386100|144612716|SUPERIORITY_OR_OTHER||Percent difference from metformin|32.1||||0.1381|TWO_SIDED|95.0|-9.5|92.7||Pre-menopausal females, Week 80. Log transformed. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||92.7|-9.5|0.1381
72541488|NCT00386100|144612716|SUPERIORITY_OR_OTHER||Percent difference from metformin|-4.3||||0.7195|TWO_SIDED|95.0|-25.4|22.7||Postmenopausal females, Week 80. Log transformed. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|.Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||22.7|-25.4|0.7195
72541489|NCT00386100|144612717|SUPERIORITY_OR_OTHER||Percent difference from metformin|-3.0||||0.5595|TWO_SIDED|95.0|-12.3|7.4||Overall, Week 80. Log transformed. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||7.4|-12.3|0.5595
72541490|NCT00386100|144612717|SUPERIORITY_OR_OTHER||Percent difference from metformin|1.0||||0.9125|TWO_SIDED|95.0|-15.3|20.4||Males, Week 80. Log transformed. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||20.4|-15.3|0.9125
72541491|NCT00386100|144612717|SUPERIORITY_OR_OTHER||Percent difference from metformin|-0.8||||0.9122|TWO_SIDED|95.0|-14.0|14.5||Females, Week 80. Log transformed. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||14.5|-14.0|0.9122
72541492|NCT00386100|144612717|SUPERIORITY_OR_OTHER||Percent difference from metformin|4.6||||0.7435|TWO_SIDED|95.0|-21.2|38.7||Pre-menopausal females, Week 80. Log transformed. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||38.7|-21.2|0.7435
72541493|NCT00386100|144612717|SUPERIORITY_OR_OTHER||Percent difference from metformin|-7.5||||0.3897|TWO_SIDED|95.0|-23.0|11.0||Postmenopausal females, Week 80. Log transformed. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|.Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||11.0|-23.0|0.3897
72541494|NCT00386100|144612718|SUPERIORITY_OR_OTHER||Percent difference from metformin|-2.83||||0.5176|TWO_SIDED|95.0|-10.97|6.06||Overall, Week 80. Log transformed. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||6.06|-10.97|0.5176
72541495|NCT00386100|144612718|SUPERIORITY_OR_OTHER||Percent difference from metformin|-6.26||||0.362|TWO_SIDED|95.0|-18.62|7.97||Males, Week 80. Log transformed. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||7.97|-18.62|0.3620
72541496|NCT00386100|144612718|SUPERIORITY_OR_OTHER||Percent difference from metformin|0.72||||0.9115|TWO_SIDED|95.0|-11.39|14.48||Females, Week 80. Log transformed. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||14.48|-11.39|0.9115
72541497|NCT00386100|144612718|SUPERIORITY_OR_OTHER||Percent difference from metformin|-13.51||||0.1956|TWO_SIDED|95.0|-30.35|8.31||Pre-menopausal females, Week 80. Log transformed. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||8.31|-30.35|0.1956
72541498|NCT00386100|144612718|SUPERIORITY_OR_OTHER||Percent difference from metformin|3.75||||0.6749|TWO_SIDED|95.0|-13.09|23.85||Postmenopausal females, Week 80. Log transformed. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|.Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||23.85|-13.09|0.6749
72541499|NCT02328807|144612726|OTHER||Negative biopsy rate at 6 months after R|0.667|||||TWO_SIDED|95.0|0.223|0.957|||||Two-sided exact confidence interval was calculated using Clopper-Pearson method.|This trail is a single cohort study and no statistical hypothesis test for the primary outcome was planned.||0.957|0.223|
72541500|NCT02020785|144612729|SUPERIORITY|Main analyses were intention-to-treat using mixed effects models allowing intercepts to vary for each individual. Carryover effects were examined by using treatment by assignment-order interaction terms. Pre-specified sensitivity analyses were conducted excluding patients who were non-compliant, prior to data analysis: 1st, noncompliance based on missing product pickups and follow-up visits; 2nd, suspected poor compliance (\< 250 mg difference between the higher and lower period).\]|Mean Difference (Final Values)|0.143||||0.05|TWO_SIDED|95.0|-0.025|0.34||For each outcome, a p value \< 0.05 was considered statistically significant without adjustment for multiple comparisons.|Mixed Models Analysis||Estimate (14.3%, 95% CI: -2.5%, 34.0%) is the estimated difference between end of higher phosphorus period and end of lower phosphorus period from mixed effects analyses for log-transformed 24-hour urine albumin excretion|Sample size for this study was calculated using the xsampsi module in STATA, based on a previous study with repeat 24-hour urine collections (standard deviation, 1.04). At an α level of 0.05, we anticipated that a sample size of 30 participants with mean albuminuria of 100 mg/d would result in \>80% power to detect a 13% difference in log- transformed albuminuria between the higher and lower phosphorus additive periods.||0.34|-0.025|0.05
72541501|NCT02020785|144612730|SUPERIORITY||Mean Difference (Final Values)|0.034||||0.05|TWO_SIDED|95.0|-0.059|0.136||For each outcome, a p value \< 0.05 was considered statistically significant without adjustment for multiple comparisons.|Mixed Models Analysis||Estimate (3.4%, 95% CI: -5.9%, 13.6%) is the estimated difference between end of higher phosphorus period and end of lower phosphorus period from mixed effects analyses for log-transformed fibroblast growth factor 23|||0.136|-0.059|0.05
72541502|NCT02020785|144612731|SUPERIORITY||mean difference (during each period)|-1.1||||0.05|TWO_SIDED|95.0|-4.1|1.9||For each outcome, a p value \< 0.05 was considered statistically significant without adjustment for multiple comparisons.|Mixed Models Analysis|||||1.9|-4.1|0.05
72541503|NCT02020785|144612732|SUPERIORITY||mean difference (during each period)|-0.8||||0.05|TWO_SIDED|95.0|-2.7|1.0||For each outcome, a p value \< 0.05 was considered statistically significant without adjustment for multiple comparisons.|Mixed Models Analysis|||||1.0|-2.7|0.05
72627823|NCT00565409|144783961|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.85|||<|0.0001|TWO_SIDED|95.0|1.8|4.6||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 88||4.6|1.8|<0.0001
72541504|NCT00701935|144612760|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.98|STANDARD_ERROR_OF_MEAN|4.432||0.8252|TWO_SIDED|95.0|-9.92|7.95||p-values were not adjusted for multiple comparisons.|ANCOVA|The ANCOVA model includes terms of treatment, gender, investigator and baseline abdominal visceral fat.||"The power calculation is based on a two-sided t-test and significance level of 0.05.~Hypotheses for sample size:~Power: 80% Drop-out rate: 20% Difference in the percentage change in abdominal visceral fat from baseline to 6 months between exenatide and placebo: 10% Common standard deviation: 15%~94 patients are needed to attain the 37 patients randomized and analyzed in each group."||7.95|-9.92|0.8252
72541505|NCT00701935|144612761|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.07|STANDARD_ERROR_OF_MEAN|3.193||0.5207|TWO_SIDED|95.0|-8.53|4.39||p-values were not adjusted for multiple comparisons.|ANCOVA|The ANCOVA model includes terms of treatment, gender, investigator and baseline total abdominal fat.||||4.39|-8.53|0.5207
72541506|NCT00701935|144612762|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.71|STANDARD_ERROR_OF_MEAN|2.687||0.1755|TWO_SIDED|95.0|-9.15|1.73||p-values were not adjusted for multiple comparisons.|ANCOVA|The ANCOVA model includes terms of treatment, gender, investigator and baseline subcutaneous abdominal fat.||||1.73|-9.15|0.1755
72541507|NCT00701935|144612763|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.88|STANDARD_ERROR_OF_MEAN|0.155|<|0.0001|TWO_SIDED|95.0|-1.19|-0.57||p-values were not adjusted for multiple comparisons.|ANCOVA|ANCOVA analysis included the following factors: treatment, gender, investigator and baseline HbA1c||||-0.57|-1.19|<0.0001
72627824|NCT00565409|144783961|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.95||||0.7837|TWO_SIDED|95.0|0.6|1.6||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 88||1.6|0.6|0.7837
72627825|NCT00565409|144783961|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.03|||<|0.0001|TWO_SIDED|95.0|2.0|4.7||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 88||4.7|2.0|<0.0001
72541508|NCT00701935|144612765|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.39|STANDARD_ERROR_OF_MEAN|0.491||0.0073|TWO_SIDED|95.0|-2.38|-0.4||p-values were not adjusted for multiple comparisons.|ANCOVA|The ANCOVA model includes terms of treatment, gender, investigator and baseline fasting plasma glucose.||||-0.40|-2.38|0.0073
72541509|NCT00701935|144612766|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.21|STANDARD_ERROR_OF_MEAN|0.725||0.0035|TWO_SIDED|95.0|-3.66|-0.76||p-values were not adjusted for multiple comparisons.|ANCOVA|The ANCOVA model includes terms of treatment, gender, investigator and baseline body weight.||||-0.76|-3.66|0.0035
72541510|NCT00701935|144612769|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.248||0.4145|TWO_SIDED|95.0|-0.71|0.3||p-values were not adjusted for multiple comparisons.|ANCOVA|The ANCOVA model includes terms of treatment, gender, investigator and baseline total cholesterol||||0.30|-0.71|0.4145
72541511|NCT00701935|144612770|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.24|STANDARD_ERROR_OF_MEAN|0.279||0.4007|TWO_SIDED|95.0|-0.8|0.33||p-values were not adjusted for multiple comparisons.|ANCOVA|The ANCOVA model includes terms of treatment, gender, investigator and baseline triglycerides||||0.33|-0.80|0.4007
72541512|NCT00701935|144612771|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.048||0.7915|TWO_SIDED|95.0|-0.08|0.11||p-values were not adjusted for multiple comparisons.|ANCOVA|The ANCOVA model includes terms of treatment, gender, investigator and baseline HDL cholesterol||||0.11|-0.08|0.7915
72541513|NCT00701935|144612772|SUPERIORITY_OR_OTHER||Ratio|3.28|STANDARD_ERROR_OF_MEAN|2.63||0.1388|TWO_SIDED|95.0|0.68|15.77||p-values were not adjusted for multiple comparisons.|Regression, Linear|Generalized linear model was used with the assumption of an underlying Poisson distribution and the logarithm of exposure (years) as offset variable.||Event rate per subject year was calculated for each subject : (number of events observed from a subject/exposure from a subject)\*365.25 where exposure = last post-baseline visit date - baseline visit date.||15.77|0.68|0.1388
72541514|NCT01783483|144612798|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||Comparison of mean CT scan scores.||||<0.0001
72541515|NCT01783483|144612799|SUPERIORITY_OR_OTHER|||||||0.0007|||||||t-test, 2 sided|||||||0.0007
72541516|NCT01783483|144612800|SUPERIORITY_OR_OTHER|||||||0.0539|||||||t-test, 2 sided|||At Rest||||0.0539
72409994|NCT01243944|144328400|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|28.01|||<|0.0001|TWO_SIDED|95.0|4.24|1144.0|||Exact Cochran-Mantel-Haenszel|||||1144|4.24|<0.0001
72541517|NCT01783483|144612800|SUPERIORITY_OR_OTHER|||||||0.0015|||||||t-test, 2 sided|||After Forced Coughing||||0.0015
72541518|NCT01783483|144612801|SUPERIORITY_OR_OTHER|||||||0.2125|||||||t-test, 2 sided|||At Rest||||0.2125
72541519|NCT01783483|144612801|SUPERIORITY_OR_OTHER|||||||0.0014|||||||t-test, 2 sided|||After Forced Coughing||||0.0014
72541520|NCT01783483|144612802|SUPERIORITY_OR_OTHER|||||||0.0049|||||||t-test, 2 sided|||At Rest||||0.0049
72541521|NCT01783483|144612802|SUPERIORITY_OR_OTHER|||||||0.0183|||||||t-test, 2 sided|||After Forced Coughing||||0.0183
72541522|NCT01783483|144612803|SUPERIORITY_OR_OTHER|||||||0.6653|||||||t-test, 2 sided|||At Rest||||0.6653
72541523|NCT01783483|144612803|SUPERIORITY_OR_OTHER|||||||0.2295|||||||t-test, 2 sided|||After Forced Coughing||||0.2295
72541524|NCT01783483|144612805|SUPERIORITY_OR_OTHER|||||||0.37|||||||t-test, 2 sided|||Index (Day 0 to Hospital Discharge)||||0.370
72541525|NCT01783483|144612806|SUPERIORITY_OR_OTHER|||||||0.778|||||||t-test, 2 sided|||From Hospital Discharge to 3-week||||0.778
72541526|NCT01783483|144612807|SUPERIORITY_OR_OTHER|||||||0.055|||||||t-test, 2 sided|||From 3-week to 6-week post-op||||0.055
72541527|NCT01783483|144612809|SUPERIORITY_OR_OTHER|||||||0.113|||||||t-test, 2 sided|||From 3 month to 6-month post op||||0.113
72627826|NCT00565409|144783962|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 4||||<0.0001
72627827|NCT00565409|144783962|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|95.0|||||Cochran-Mantel-Haenszel|||Week 8||||<0.0001
72627828|NCT00565409|144783962|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|95.0|||||Cochran-Mantel-Haenszel|||Week 12||||<0.0001
72627829|NCT00565409|144783962|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|95.0|||||Cochran-Mantel-Haenszel|||Week 20||||<0.0001
72541528|NCT03056001|144612838|OTHER|Estimation only.|Rate|0.0333|||||TWO_SIDED|95.0|0.0008|0.1722|||||Confidence interval estimated using the Clopper Pearson method.|The reported severe or life-threatening adverse event rate with weekly doxorubicin and dacarbazine was 0.55. If it became evident that the rate of severe or life-threatening toxicity convincingly exceeded 0.55, the study would have been halted. Convincing evidence of exceeding 0.55 was based on Bayesian methods and continuous monitoring, where the stopping rule would have held enrollment if the posterior probability at any point exceeded 0.75 or higher.||0.1722|0.0008|
72575933|NCT01346293|144678161|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority of DTaP-IPV was demonstrated if the lower limits of the 2-sided 95% CIs of the difference (DTaP-IPV minus DAPTACEL® + IPOL®) in post-vaccination booster response rates for Fimbriae types 2 and 3 antigens between groups were \> -10%.|Mean Difference (Final Values)|4.8|||||TWO_SIDED|95.0|0.9|9.1||||||Non-inferiority comparison of post-vaccination anti-pertussis booster response rates in the Per-protocol Analysis Set. The hypothesis was based on testing the difference between 2 proportion parameters.||9.1|0.9|
72575934|NCT01346293|144678162|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority of DTaP-IPV was demonstrated if the lower limits of the 2-sided 95% CIs of the ratio (DTaP-IPV / DAPTACEL® + IPOL®) in post-vaccination GMCs for the Pertussis Toxoid antigens between groups were \> 2/3.|Mean Difference (Final Values)|1.97|||||TWO_SIDED|95.0|1.68|2.31||||||Hypothesis was based on testing the ratio between the 2 post-vaccination GMCs (GMCQ / GMCD) for each Pertussis antigen and their 2-sided 95% Confidence Intervals.||2.31|1.68|
72575935|NCT01346293|144678162|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority of DTaP-IPV was demonstrated if the lower limits of the 2-sided 95% CIs of the ratio (DTaP-IPV / DAPTACEL® + IPOL®) in post-vaccination GMCs for the Filamentous Haemagglutinin antigens between groups were \> 2/3.|Mean Difference (Final Values)|1.56|||||TWO_SIDED|95.0|1.3|1.88||||||Hypothesis was based on testing the ratio between the 2 post-vaccination GMCs (GMCQ / GMCD) for each pertussis antigen and their 2-sided 95% Confidence Intervals.||1.88|1.30|
72575936|NCT01346293|144678162|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority of DTaP-IPV was demonstrated if the lower limits of the 2-sided 95% CIs of the ratio (DTaP-IPV / DAPTACEL® + IPOL®) in post-vaccination GMCs for the Pertactin antigens between groups were \> 2/3.|Mean Difference (Final Values)|1.51|||||TWO_SIDED|95.0|1.27|1.79||||||Hypothesis was based on testing the ratio between the 2 post-vaccination GMCs (GMCQ / GMCD) for each pertussis antigen and their 2-sided 95% Confidence Intervals.||1.79|1.27|
72575937|NCT01346293|144678162|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority of DTaP-IPV was demonstrated if the lower limits of the 2-sided 95% CIs of the ratio (DTaP-IPV / DAPTACEL® + IPOL® ) in post-vaccination GMCs for the Fimbriae types 2 and 3 antigens between groups were \> 2/3.|Mean Difference (Final Values)|1.33|||||TWO_SIDED|95.0|1.12|1.6||||||Hypothesis was based on testing the ratio between the 2 post-vaccination GMCs (GMCQ / GMCD) for each pertussis antigen and their 2-sided 95% Confidence Intervals.||1.60|1.12|
72575938|NCT02687217|144678180|SUPERIORITY_OR_OTHER|||||||0.5|||||||Wilcoxon (Mann-Whitney)|||||||0.5
72575939|NCT02687217|144678181|SUPERIORITY_OR_OTHER|||||||0.5|||||||Chi-squared|||||||0.5
72575940|NCT02687217|144678182|SUPERIORITY_OR_OTHER|||||||0.5|||||||Chi-squared|||||||0.5
72409995|NCT01243944|144328401|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.57||||0.0016|TWO_SIDED|95.0|1.5|9.06|||Exact Cochran-Mantel-Haenszel|P-value was calculated using stratified exact Cochran-Mantel-Haenszel test by adjusting for the WBC/platelet status (abnormal vs normal) at baseline.||||9.06|1.50|0.0016
72575941|NCT01798316|144678227|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Chi-squared|||||||>0.05
72575942|NCT04693416|144678259|OTHER|||||||0.252|||||||t-test, 2 sided|||Pre/post scores within arm||||0.252
72575943|NCT04693416|144678260|OTHER|||||||0.546|||||||t-test, 2 sided|||Pre/post score within arm||||0.546
72575944|NCT04693416|144678261|OTHER|||||||0.005|||||||t-test, 2 sided|||Pre/post scores within arm||||0.005
72575945|NCT04693416|144678262|OTHER|||||||0.188|||||||t-test, 2 sided|||Pre/post scores within arm||||0.188
72575946|NCT04693416|144678263|OTHER|||||||0.049|||||||t-test, 2 sided|||Pre/post score within arm||||0.049
72409996|NCT04632940|144328421|OTHER||LS Mean Difference|-0.528|STANDARD_ERROR_OF_MEAN|0.8912||0.5553|TWO_SIDED|95.0|-2.308|1.251|||Mixed Models Analysis|||||1.251|-2.308|0.5553
72541529|NCT03056001|144612839|OTHER|Estimation only|Median|1.3|||||TWO_SIDED|95.0|0.8|2.1|||||The Kaplan Meier method was used to estimate the median OS (in years) for the population. The Greenwood method was used to estimate the confidence limits of the median overall survival.|||2.1|0.8|
72575947|NCT04693416|144678264|OTHER|||||||0.036|||||||t-test, 2 sided|||Pre/post scores within arm||||0.036
72575948|NCT00474266|144678266|NON_INFERIORITY|Non-inferiority criterion: Lower limit \[LL\] of the 2-sided standardized asymptotic 95% confidence interval \[CI\] ≥-10%.|Difference in percentage|2.2|||||TWO_SIDED|95.0|0.29|6.78||||||||6.78|0.29|
72575949|NCT00474266|144678266|NON_INFERIORITY|Non-inferiority criterion: Lower limit \[LL\] of the 2-sided standardized asymptotic 95% confidence interval \[CI\] ≥ -10%|Difference in percentage|0.28|||||TWO_SIDED|95.0|-0.78|1.58||||||||1.58|-0.78|
72575950|NCT00474266|144678266|NON_INFERIORITY|Non-inferiority criterion: Lower limit \[LL\] of the 2-sided standardized asymptotic 95% confidence interval \[CI\] ≥ -10%.|Difference in percentage|0.28|||||TWO_SIDED|95.0|-0.79|1.58||||||||1.58|-0.79|
72575951|NCT00474266|144678266|NON_INFERIORITY|Non-inferiority criterion: Lower limit \[LL\] of the 2-sided standardized asymptotic 95% confidence interval \[CI\] ≥ -10%.|Difference in percentage|0.0|||||TWO_SIDED|95.0|-1.06|1.07||||||||1.07|-1.06|
72575952|NCT00474266|144678267|NON_INFERIORITY|Non-inferiority criterion: Lower limit \[LL\] of the 2-sided standardized asymptotic 95% confidence interval \[CI\] ≥ -10%.|Difference in percentage|0.0|||||TWO_SIDED|95.0|-1.06|3.17||||||||3.17|-1.06|
72575953|NCT00474266|144678268|NON_INFERIORITY|Non-inferiority criterion: Lower limit \[LL\] of the 2-sided standardized asymptotic 95% confidence interval \[CI\] ≥-10%.|Difference in percentage|4.06|||||TWO_SIDED|95.0|-2.82|12.46||||||||12.46|-2.82|
72575954|NCT00474266|144678269|NON_INFERIORITY|Non-inferiority criterion: Lower limit \[LL\] of the 2-sided standardized asymptotic 95% confidence interval \[CI\] ≥ -10%|Difference in percentage|0.0|||||TWO_SIDED|95.0|-1.06|3.18||||||||3.18|-1.06|
72575955|NCT00474266|144678270|NON_INFERIORITY|Non-inferiority criterion: Lower limit \[LL\] of the 2-sided standardized asymptotic 95% confidence interval \[CI\] ≥-10%.|Difference in percentage|3.36|||||TWO_SIDED|95.0|-0.28|9.5||||||||9.5|-0.28|
72627830|NCT00565409|144783962|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|95.0|||||Cochran-Mantel-Haenszel|||Week 28||||<0.0001
72627831|NCT00565409|144783962|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|95.0|||||Cochran-Mantel-Haenszel|||Week 36||||<0.0001
72409997|NCT02799082|144328426|SUPERIORITY_OR_OTHER||||||<|0.0001||||||"The percentages stated relate to the total number of subjects for the respective week and treatment.~Cochran-Mantel-Haenszel Test stratified by center"|Cochran-Mantel-Haenszel|||||||<0.0001
72409998|NCT02799082|144328427|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
72541530|NCT03056001|144612840|OTHER|Estimation only|Median|5.7|||||TWO_SIDED|95.0|4.1|8.3|||||The Kaplan Meier method was used to estimate the median PFS (in months) for the population. The Greenwood method was used to estimate the confidence limits of the median progression free survival.|||8.3|4.1|
72541531|NCT03056001|144612841|OTHER|Estimation only.|Rate|0.367|||||TWO_SIDED|95.0|0.199|0.561|||||Confidence interval estimated using the Clopper Pearson method.|||0.561|0.199|
72541532|NCT03056001|144612842|OTHER|Estimation only|Median|8.0|||||TWO_SIDED|95.0|2.8|34.6|||||The Kaplan Meier method was used to estimate the median DoR (in months) for the population. The Greenwood method was used to estimate the confidence limits of the median duration of response.|||34.6|2.8|
72409999|NCT02799082|144328435|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
72410000|NCT02799082|144328436|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
72541533|NCT00363129|144612846|SUPERIORITY_OR_OTHER|||||||0.43|||||||Chi-squared|||||||0.43
72541534|NCT00363129|144612847|SUPERIORITY_OR_OTHER|||||||0.49|||||||Fisher Exact|||||||0.49
72541535|NCT00363129|144612848|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||||||1.00
72541536|NCT03567239|144612879|OTHER|"The PIADS is broken into 3 subgroups - Competence, Adaptability, and Self-Esteem. The minimum possible score is -3 and the maximum possible score is 3 for each subgroup - with positive 3 being the best. The 7-Point Likert scale was used in response to the question The device provided increased my ability to … in relation to the custom need they had. A response of 1 = Strongly disagree and 7 = strongly agree."|||||||||||||||||Median values: Overall = 2.42, Competence = 2.58, Adaptability = 2.33, Self-Esteem = 2.00, Likert = 7|||
72410001|NCT02442700|144328452|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Mixed Models Analysis|||||||<0.05
72541537|NCT03567239|144612880|OTHER|||||||||||||||||The NASA Task Load Index ranges from 1 to 21 with the lower the score the better.|Median vales: Overall = 4.83, Mental demand = 11, Physical demand = 4, Temporal demand = 6, Performance = 3, Effort = 3, Frustration = 5.|||
72541538|NCT03567239|144612881|OTHER|Median QUEST scores: Overall = 4.33, Device = 4.38, Services = 4.25.||||||||||||||||The QUEST (Quebec User Evaluation of Satisfaction with Assistive Technology) evaluates a patient's satisfaction with various assistive technologies. It has two subgroups, Device and Service on a scale of 1-5 with 5 being the best score.|Median QUEST scores: Overall = 4.33, Device = 4.38, Services = 4.25.|||
72541539|NCT00725725|144612885|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.5299||||0.3934|TWO_SIDED|95.0|-2.0781|5.138|||Mixed Models Analysis|||||5.1380|-2.0781|0.3934
72575956|NCT03344861|144678299|OTHER|No comparator arm.|Clopper-Pearson (binomial proportion)|0.05|||<|0.05|TWO_SIDED||||||exact Clopper-Pearson binomial method|One-sided 95% upper confidence limit for the event percentage was calculated using exact (Clopper-Pearson) method for binomial proportion.|One-sided 95% upper confidence limit for the event percentage was calculated using exact (Clopper-Pearson) method for binomial proportion|Adverse events will be listed, coded by MedDRA, by system organ class and preferred term.||||<0.05
72576816|NCT00261443|144680655|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.39||||0.006|TWO_SIDED|95.0|-0.67|-0.12||Baseline: ANOVA model, controlling for treatment, mood stabilizer, and index mood episode. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 48 Comparison||-0.12|-0.67|0.006
72410002|NCT00752908|144328454|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
72410003|NCT00153101|144328456|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.99||||0.8462||95.0|0.92|1.07|||Regression, Cox|||||1.07|0.92|0.8462
72410004|NCT00153101|144328456|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin was 1.13|Hazard Ratio (HR)|1.01||||0.0019||97.5|0.93|1.1|||Regression, Cox|||||1.10|0.93|0.0019
72410005|NCT00153101|144328457|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.0||||0.9086||95.0|0.93|1.09|||Regression, Cox|||||1.09|0.93|0.9086
72410006|NCT00153101|144328457|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin was 1.13|Hazard Ratio (HR)|0.99||||0.0004||97.5|0.9|1.08|||Regression, Cox|||||1.08|0.90|0.0004
72410007|NCT00153101|144328458|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.04||||0.4535||95.0|0.93|1.17|||Regression, Cox|||||1.17|0.93|0.4535
72541540|NCT00725725|144612885|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.2667||||0.3515|TWO_SIDED|95.0|-1.4665|4.0|||Mixed Models Analysis|||||4.0000|-1.4665|0.3515
72541541|NCT00725725|144612886|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.8246||||0.3597|TWO_SIDED|95.0|-5.8307|2.1815|||Mixed Models Analysis|||||2.1815|-5.8307|0.3597
72541542|NCT00725725|144612886|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4414||||0.777|TWO_SIDED|95.0|-3.5952|2.7124|||Mixed Models Analysis|||||2.7124|-3.5952|0.7770
72541543|NCT00725725|144612887|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.3356||||0.2683|TWO_SIDED|95.0|-1.8933|6.5644|||Mixed Models Analysis|||||6.5644|-1.8933|0.2683
72541544|NCT00725725|144612887|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.1317||||0.0844|TWO_SIDED|95.0|-0.4518|6.7152|||Mixed Models Analysis|||||6.7152|-0.4518|0.0844
72541545|NCT00725725|144612891|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3456||||0.8894|TWO_SIDED|95.0|-4.6211|5.3124|||Mixed Models Analysis|||||5.3124|-4.6211|0.8894
72541546|NCT00725725|144612891|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.0417||||0.3765|TWO_SIDED|95.0|-2.5526|6.636|||Mixed Models Analysis|||||6.6360|-2.5526|0.3765
72410008|NCT00153101|144328458|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.0||||0.9421||95.0|0.89|1.12|||Regression, Cox|||||1.12|0.89|0.9421
72541547|NCT00725725|144612892|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.2502||||0.8073|TWO_SIDED|95.0|-11.4963|8.9958|||Mixed Models Analysis|||||8.9958|-11.4963|0.8073
72541548|NCT00725725|144612892|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.0291||||0.661|TWO_SIDED|95.0|-7.2132|11.2714|||Mixed Models Analysis|||||11.2714|-7.2132|0.6610
72541549|NCT00725725|144612893|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.7296||||0.7895|TWO_SIDED|95.0|-4.7291|6.1883|||Mixed Models Analysis|||||6.1883|-4.7291|0.7895
72541550|NCT00725725|144612893|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.526||||0.5488|TWO_SIDED|95.0|-3.5495|6.6015|||Mixed Models Analysis|||||6.6015|-3.5495|0.5488
72541551|NCT00725725|144612894|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.2766||||0.6516|TWO_SIDED|95.0|-6.9269|4.3738|||Mixed Models Analysis|||||4.3738|-6.9269|0.6516
72410009|NCT00153101|144328459|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.08||||0.2909||95.0|0.94|1.23|||Regression, Cox|||||1.23|0.94|0.2909
72541552|NCT00725725|144612894|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.1867||||0.0256|TWO_SIDED|95.0|-11.5864|-0.7869|||Mixed Models Analysis|||||-0.7869|-11.5864|0.0256
72541553|NCT05003167|144612918|SUPERIORITY||F|8.48||||0.001|TWO_SIDED|95.0|||||ANOVA|||A mixed model ANOVA with session (pre-post-training) as a main effect and participant as a random factor was run via SAS 9.4. Alpha was set at .05.||||.001
72541554|NCT05003167|144612920|SUPERIORITY||F|2.29||||0.113|TWO_SIDED|95.0|||||ANOVA|df = 2,44||A mixed model ANOVA with session (pre-post-training) as a main effect and participant as a random factor was run via SAS 9.4. Alpha was set at .05.||||.113
72541555|NCT05003167|144612921|SUPERIORITY||F|3.17||||0.052|TWO_SIDED|95.0|||||ANOVA|||A mixed model ANOVA with session (pre-post-training) as a main effect and participant as a random factor was run via SAS 9.4. Alpha was set at .05.||||.052
72541556|NCT05003167|144612922|SUPERIORITY||F|0.07||||0.931|TWO_SIDED|95.0|||||ANOVA|||"A mixed model ANOVA with session (pre-post-training) as a main effect and participant as a random factor was run via SAS 9.4. Alpha was set at .05.~Results here are for percent of breaths at major boundaries."||||.931
72541557|NCT05003167|144612922|SUPERIORITY||F|0.23||||0.164|TWO_SIDED|95.0|||||ANOVA|||A mixed model ANOVA with session (pre-post-training) as a main effect and participant as a random factor was run via SAS 9.4. Alpha was set at .05. Results reflect percent of breaths at boundaries unrelated to syntax.||||0.164
72541558|NCT02367781|144612930|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.639|||<|0.0001|TWO_SIDED|95.0|0.536|0.763|||Log Rank|||||0.763|0.536|<.0001
72541559|NCT02367781|144612931|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.788||||0.0298|TWO_SIDED|95.0|0.636|0.977|||Log Rank|||||0.977|0.636|0.0298
72541560|NCT02367781|144612932|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.647|||<|0.0001|TWO_SIDED|95.0|0.545|0.768|||Log Rank|||ITT Population||0.768|0.545|<0.0001
72541561|NCT02367781|144612932|SUPERIORITY|Unstratified Analysis|Hazard Ratio (HR)|0.561|||<|0.0001|TWO_SIDED|95.0|0.432|0.728|||Log Rank|||TC1/2/3 or IC1/2/3-WT ITT Population||0.728|0.432|<0.0001
72541562|NCT02367781|144612932|SUPERIORITY|Unstratified Analysis|Hazard Ratio (HR)|0.549|||<|0.0001|TWO_SIDED|95.0|0.425|0.708|||Log Rank|||TC1/2/3 or IC1/2/3 ITT Population||0.708|0.425|<0.0001
72541563|NCT02367781|144612933|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.837||||0.0732|TWO_SIDED|95.0|0.689|1.017|||Log Rank|||||1.017|0.689|0.0732
72541564|NCT02367781|144612934|SUPERIORITY|Unstratified Analysis|Hazard Ratio (HR)|0.752||||0.083|TWO_SIDED|95.0|0.545|1.039|||Log Rank|||TC1/2/3 or IC1/2/3 ITT Population||1.039|0.545|0.0830
72541565|NCT02367781|144612934|SUPERIORITY|Unstratified Analysis|Hazard Ratio (HR)|0.746||||0.0813|TWO_SIDED|95.0|0.536|1.038|||Log Rank|||TC1/2/3 or IC1/2/3 WT ITT Population||1.038|0.536|0.0813
72541566|NCT02367781|144612935|SUPERIORITY|Stratified Analysis|Difference in Response Rate|19.21|||<|0.0001|TWO_SIDED|95.0|11.05|27.37|||Cochran-Mantel-Haenszel||Wald with Continuity Correction|||27.37|11.05|<.0001
72541567|NCT02367781|144612936|SUPERIORITY|Unstratified Analysis|Difference in Response Rate|16.89|||<|0.0001|TWO_SIDED|95.0|8.9|24.88|||Cochran-Mantel-Haenszel||Wald with Continuity Correction|ITT Population||24.88|8.90|<.0001
72541568|NCT02367781|144612936|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|2.22|||||TWO_SIDED|95.0|1.38|3.56||||||TC1/2/3 or IC1/2/3 ITT WT Population||3.56|1.38|
72541569|NCT02367781|144612936|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|2.21||||0.0007|TWO_SIDED|95.0|1.39|3.51|||Cochran-Mantel-Haenszel|||TC1/2/3 or IC1/2/3 ITT Population||3.51|1.39|0.0007
72541570|NCT02367781|144612937|SUPERIORITY|Unstratified Analysis|Hazard Ratio (HR)|0.614||||0.0002|TWO_SIDED|95.0|0.473|0.797|||Log Rank|||ITT Population||0.797|0.473|0.0002
72541571|NCT02367781|144612937|SUPERIORITY|Unstratified Analysis|Hazard Ratio (HR)|0.6||||0.0002|TWO_SIDED|95.0|0.458|0.785|||Log Rank|||ITT-WT Population||0.785|0.458|0.0002
72541572|NCT02367781|144612937|SUPERIORITY|Unstratified Analysis|Hazard Ratio (HR)|0.548||||0.0011|TWO_SIDED|95.0|0.379|0.791|||Log Rank|||TC1/2/3 or IC1/2/3 ITT Population||0.791|0.379|0.0011
72541573|NCT02367781|144612937|SUPERIORITY|Unstratified Analysis|Hazard Ratio (HR)|0.551||||0.0014|TWO_SIDED|95.0|0.381|0.798|||Log Rank|||TC1/2/3 or IC1/2/3 ITT WT Population||0.798|0.381|0.0014
72541574|NCT02367781|144612938|SUPERIORITY||Difference in Event Free Rate|7.46||||0.0647|TWO_SIDED|95.0|-0.45|15.37|||Z-test|||Event Free Rate (%) at Year 1 ITT WT Population||15.37|-0.45|0.0647
72541575|NCT02367781|144612938|SUPERIORITY||Difference in Event Free Rate|8.07||||0.0516|TWO_SIDED|95.0|-0.06|16.19|||Z-test|||Event Free Rate (%) at Year 2 ITT WT Population||16.19|-0.06|0.0516
72541576|NCT02367781|144612938|SUPERIORITY||Difference in Event Free Rate|7.19||||0.0683|TWO_SIDED|95.0|-0.54|14.91|||Z-test|||Event Free Rate (%) at Year 1 ITT Population||14.91|-0.54|0.0683
72541577|NCT02367781|144612938|SUPERIORITY||Difference in Event Free Rate|7.53||||0.0625|TWO_SIDED|95.0|-0.39|15.44|||Z-test|||Event Free Rate (%) at Year 2 ITT Population||15.44|-0.39|0.0625
72541578|NCT02367781|144612939|SUPERIORITY||Difference in Event Free Rate|6.69||||0.2385|TWO_SIDED|95.0|-4.44|17.83|||Z-test|||Event Free Rate (%) at Year 1 TC1/2/3 or IC1/2/3 ITT||17.83|-4.44|0.2385
72410010|NCT00153101|144328459|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.08||||0.2534||95.0|0.94|1.24|||Regression, Cox|||||1.24|0.94|0.2534
72410011|NCT00153101|144328460|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.92||||0.2248||95.0|0.79|1.06|||Regression, Cox|||||1.06|0.79|0.2248
72410012|NCT00153101|144328460|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.91||||0.1829||95.0|0.79|1.05|||Regression, Cox|||||1.05|0.79|0.1829
72410013|NCT00153101|144328461|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.95||||0.4984||95.0|0.82|1.1|||Regression, Cox|||||1.10|0.82|0.4984
72541579|NCT02367781|144612939|SUPERIORITY||Difference in Event Free Rate|8.64||||0.271|TWO_SIDED|95.0|-6.75|24.03|||Z-test|||Event Free Rate (%) at Year 2 TC1/2/3 or IC1/2/3 ITT||24.03|-6.75|0.2710
72541580|NCT02367781|144612939|SUPERIORITY||Difference in Event Free Rate|6.34||||0.2733|TWO_SIDED|95.0|-5.0|17.67|||Z-test|||Event Free Rate (%) Year 1 TC1/2/3 or IC1/2/3 ITT WT||17.67|-5.00|0.2733
72541581|NCT02367781|144612939|SUPERIORITY||Difference in Event Free Rate|8.69||||0.2909|TWO_SIDED|95.0|-7.44|24.81|||Z-test|||Event Free Rate (%) Year 2 TC1/2/3 or IC1/2/3 ITT WT||24.81|-7.44|0.2909
72575957|NCT03344861|144678324|OTHER||||||<|0.05|||||||exact Clopper-Pearson binomial method|One-sided 95% upper confidence limit for the event percentage, calculated using exact (Clopper-Pearson) method for binomial proportion.||"All adverse event terms are coded using MedDRA Dictionary version 21.1. NCS (Non-Clinical Significant) events were not included in the summary because their CTCAE grade and relationship were not collected. Subjects are counted once within each system organ class and each preferred term. An AE is defined as treatment related if its relationship to the study drug is recorded as reasonable possibility on the CRF (Case Report Form)."||||<0.05
72575958|NCT00469911|144678343|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
72575959|NCT00213135|144678355|SUPERIORITY_OR_OTHER||Relative Risk|0.43|STANDARD_ERROR_OF_MEAN|0.11|<|0.001|TWO_SIDED|95.0|0.35|0.54|||Wald Chi-square test|||||0.54|0.35|<0.001
72575960|NCT00213135|144678355|SUPERIORITY_OR_OTHER||Relative Risk|0.43|STANDARD_ERROR_OF_MEAN|0.12|<|0.001|TWO_SIDED|95.0|0.34|0.54|||Wald Chi-square test|||||0.54|0.34|<0.001
72575961|NCT01056289|144678386|NON_INFERIORITY_OR_EQUIVALENCE|Null hypothesis: absolute difference between the 2 discontinuation regimens in DESS total scores was \>2.5. Alternative hypothesis: absolute difference was ≤2.5; tested by calculating 95% 2-sided confidence intervals (CIs) on the mean difference between the 2 regimens. If absolute values of both confidence limits were ≤2.5, then the regimens were declared equivalent.|Mean Difference (Final Values)|1.16|||||TWO_SIDED|95.0|-0.51|2.83|||ANCOVA|||Difference: Placebo versus DVS SR 50 mg||2.83|-0.51|
72575962|NCT01056289|144678386|NON_INFERIORITY_OR_EQUIVALENCE|Null hypothesis: absolute difference between the 2 discontinuation regimens in DESS total scores was \>2.5. Alternative hypothesis: absolute difference was ≤2.5; tested by calculating 95% 2-sided confidence intervals (CIs) on the mean difference between the 2 regimens. If absolute values of both confidence limits were ≤2.5, then the regimens were declared equivalent.|Mean Difference (Final Values)|0.66|||||TWO_SIDED|95.0|-1.03|2.35|||ANCOVA|||Difference: DVS SR 25 mg versus DVS SR 50 mg||2.35|-1.03|
72575963|NCT01056289|144678386|NON_INFERIORITY_OR_EQUIVALENCE|Null hypothesis: absolute difference between the 2 discontinuation regimens in DESS total scores was \>2.5. Alternative hypothesis: absolute difference was ≤2.5; tested by calculating 95% 2-sided confidence intervals (CIs) on the mean difference between the 2 regimens. If absolute values of both confidence limits were ≤2.5, then the regimens were declared equivalent.|Mean Difference (Final Values)|0.5|||||TWO_SIDED|95.0|-0.88|1.89|||ANCOVA|||Difference: Placebo versus DVS SR 25 mg||1.89|-0.88|
72575964|NCT01917916|144678390|OTHER||Slope|2.4386|STANDARD_ERROR_OF_MEAN|0.3417|||TWO_SIDED|95.0|1.7504|3.1267|||||Perfect dose proportionality would correspond to a slope of 1. Standard error of mean is actually standard error of slope.|Dose proportionality was explored using the power model. Dose proportionality of BI 655064 was to be assessed based on the exposure parameter Cmax, determined for the 4 subcutaneous dose levels. This analysis is for the overall population.||3.1267|1.7504|
72575965|NCT01917916|144678391|OTHER||Slope|2.6033|STANDARD_ERROR_OF_MEAN|0.2499|||TWO_SIDED|95.0|2.0993|3.1073|||||Perfect dose proportionality would correspond to a slope of 1. Standard error of mean is actually standard error of slope.|Dose proportionality was explored using the power model. Dose proportionality of BI 655064 was to be assessed based on the exposure parameter AUC0-∞, determined for the 4 subcutaneous dose levels. This analysis is for the overall population.||3.1073|2.0993|
72627832|NCT00565409|144783963|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.2||||0.5263|TWO_SIDED|95.0|0.7|2.0||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 36||2.0|0.7|0.5263
72627833|NCT00565409|144783963|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.41||||0.1055|TWO_SIDED|95.0|0.9|2.3||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 36||2.3|0.9|0.1055
72627834|NCT00565409|144783963|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.85||||0.4348|TWO_SIDED|95.0|0.5|1.4||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 36||1.4|0.5|0.4348
72627835|NCT00565409|144783963|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.16||||0.0003|TWO_SIDED|95.0|1.4|3.3||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 40||3.3|1.4|0.0003
72410014|NCT00153101|144328461|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.12||||0.1203||95.0|0.97|1.29|||Regression, Cox|||||1.29|0.97|0.1203
72410015|NCT00153101|144328462|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.25||||0.4221|TWO_SIDED|95.0|0.73|2.15|||Regression, Cox|||||2.15|0.73|0.4221
72410016|NCT00153101|144328462|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.9||||0.7305||95.0|0.51|1.6|||Regression, Cox|||||1.60|0.51|0.7305
72410017|NCT00153101|144328463|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.88||||0.6248||95.0|0.54|1.45|||Regression, Cox|||||1.45|0.54|0.6248
72541582|NCT02367781|144612940|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.893||||0.3342|TWO_SIDED|95.0|0.711|1.123|||Log Rank|||||1.123|0.711|0.3342
72541583|NCT02517099|144612948|SUPERIORITY||Median Difference (Final Values)|2.0|STANDARD_ERROR_OF_MEAN|0.384||0.05|TWO_SIDED|95.0|1.591|8.8|||Wilcoxon (Mann-Whitney)|||||8.80|1.591|0.05
72541584|NCT01133392|144612952|SUPERIORITY_OR_OTHER||Ratio of geometric least square means|0.99|||||TWO_SIDED|90.0|0.948|1.034||||||||1.034|0.948|
72410018|NCT00153101|144328463|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.62||||0.0751|TWO_SIDED|95.0|0.36|1.05|||Regression, Cox|||||1.05|0.36|0.0751
72410019|NCT00153101|144328464|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.87||||0.3682||95.0|0.63|1.18|||Regression, Cox|||||1.18|0.63|0.3682
72541585|NCT01133392|144612953|SUPERIORITY_OR_OTHER||Ratio of geometric least square means|0.933|||||TWO_SIDED|90.0|0.897|0.972||||||||0.972|0.897|
72541586|NCT01133392|144612954|SUPERIORITY_OR_OTHER||Ratio of geometric least square means|1.005|||||TWO_SIDED|90.0|0.958|1.054||||||||1.054|0.958|
72541587|NCT01133392|144612955|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.1|||||TWO_SIDED|90.0|-0.4|0.5||||||||0.500|-0.400|
72541588|NCT01133392|144612956|SUPERIORITY_OR_OTHER||Ratio of geometric least square means|1.014|||||TWO_SIDED|90.0|0.961|1.07||||||||1.070|0.961|
72541589|NCT02842086|144612959|NON_INFERIORITY|Noninferiority of DVY to TVD was to be concluded if the upper bound of the 2-sided 95.003% CI of the rate ratio (DVY group over TVD group) in the HIV infection incidence rate was less than 1.62.|Rate Ratio|0.468|||||TWO_SIDED|95.003|0.191|1.149||||||Noninferiority was assessed using a 95.003% confidence interval (CI) constructed using a generalized model associated with a Poisson distribution and logarithmic link with the treatment group being the main effect and with a noninferiority margin of 1.62.||1.149|0.191|
72541590|NCT02842086|144612960|SUPERIORITY||Difference in least squares mean (LSM)|1.142|||<|0.0001|TWO_SIDED|95.0|0.628|1.655|||ANOVA|||Hip BMD results were compared between the 2 treatment groups using analysis of variance (ANOVA), which included baseline TVD for pre-exposure prophylaxis (PrEP) and treatment as fixed effects.||1.655|0.628|<0.0001
72541591|NCT02842086|144612961|SUPERIORITY||Difference in LSM|1.567|||<|0.0001|TWO_SIDED|95.0|0.913|2.22|||ANOVA|||Spine BMD results were compared between the 2 treatment groups using ANOVA, which included baseline TVD for PrEP and treatment as fixed effects.||2.220|0.913|<0.0001
72541592|NCT02842086|144612962|SUPERIORITY||||||<|0.0001||||||P-values were from the Van Elteren test stratified by baseline TVD for PrEP.|Van Elteren test|||||||<0.0001
72541593|NCT02842086|144612963|SUPERIORITY||||||<|0.0001||||||P-values were from the Van Elteren test stratified by baseline TVD for PrEP.|Van Elteren test|||||||<0.0001
72541594|NCT02842086|144612964|SUPERIORITY|||||||0.0048||||||P-value for difference between treatment groups in distributions of UPCR ≤ 200 mg/g versus \> 200 mg/g was from the rank analysis of covariance adjusting for baseline category and baseline TVD for PrEP.|Rank analysis of covariance|||||||0.0048
72541595|NCT02842086|144612965|SUPERIORITY||Difference in LSM|-0.02|||<|0.0001|TWO_SIDED|95.0|-0.02|-0.01|||ANCOVA|||Results were compared between the 2 treatment groups using the analysis of covariance (ANCOVA) model including baseline TVD for PrEP and treatment as fixed effects and baseline serum creatinine as a covariate.||-0.01|-0.02|<0.0001
72541596|NCT02842086|144612966|NON_INFERIORITY|Noninferiority of DVY to TVD was to be concluded if the upper bound of the 2-sided 95.003% CI of the rate ratio (DVY group over TVD group) in the HIV infection incidence rate was less than 1.62.|Rate Ratio|0.536|||||TWO_SIDED|95.003|0.227|1.264||||||Noninferiority was assessed using a 95.003% CI constructed using a generalized model associated with a Poisson distribution and logarithmic link with the treatment group being the main effect and with a noninferiority margin of 1.62.||1.264|0.227|
72541597|NCT02842086|144612967|SUPERIORITY||Difference in LSM|1.567|||<|0.0001|TWO_SIDED|95.0|0.896|2.237|||ANOVA|||Hip BMD results were compared between the 2 treatment groups using ANOVA, which included baseline TVD for PrEP and treatment as fixed effects.||2.237|0.896|<0.0001
72410020|NCT00153101|144328464|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.92||||0.6014||95.0|0.69|1.24|||Regression, Cox|||||1.24|0.69|0.6014
72410021|NCT00153101|144328465|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.14||||0.255||95.0|0.91|1.42|||Regression, Cox|||||1.42|0.91|0.2550
72410022|NCT00153101|144328465|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.07||||0.5297||95.0|0.86|1.34|||Regression, Cox|||||1.34|0.86|0.5297
72410023|NCT00153101|144328466|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.13||||0.4593||95.0|0.82|1.56|||Regression, Cox|||||1.56|0.82|0.4593
72410024|NCT00153101|144328466|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.95||||0.7468||95.0|0.68|1.32|||Regression, Cox|||||1.32|0.68|0.7468
72410025|NCT00153101|144328467|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.92||||0.5461|TWO_SIDED|95.0|0.71|1.2|||Regression, Cox|||||1.20|0.71|0.5461
72410026|NCT00153101|144328467|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.88||||0.3436||95.0|0.68|1.14|||Regression, Cox|||||1.14|0.68|0.3436
72410027|NCT00153101|144328468|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.88||||0.0133||95.0|0.8|0.97|||Regression, Cox|||||0.97|0.80|0.0133
72541598|NCT02842086|144612968|SUPERIORITY||Difference in LSM|2.253|||<|0.0001|TWO_SIDED|95.0|1.437|3.069|||ANOVA|||Spine BMD results were compared between the 2 treatment groups using ANOVA, which included baseline TVD for PrEP and treatment as fixed effects.||3.069|1.437|<0.0001
72541599|NCT02842086|144612969|SUPERIORITY||||||<|0.0001||||||P-values were from the Van Elteren test stratified by baseline TVD for PrEP.|Van Elteren test|||||||<0.0001
72541600|NCT02842086|144612970|SUPERIORITY||||||<|0.0001||||||P-values were from the Van Elteren test stratified by baseline TVD for PrEP.|Van Elteren test|||||||<0.0001
72541601|NCT02842086|144612971|SUPERIORITY|||||||0.2163||||||P-value for difference between treatment groups in distributions of UPCR ≤ 200 mg/g versus \> 200 mg/g was from the rank analysis of covariance adjusting for baseline category and baseline TVD for PrEP.|Rank analysis of covariance|||||||0.2163
72541602|NCT02842086|144612972|SUPERIORITY||Difference in LSM|-0.02|||<|0.0001|TWO_SIDED|95.0|-0.02|-0.01|||ANCOVA|||Results were compared between the 2 treatment groups using the ANCOVA model including baseline TVD for PrEP and treatment as fixed effects and baseline serum creatinine as a covariate.||-0.01|-0.02|<0.0001
72575966|NCT01917916|144678392|OTHER||Slope|3.1291|STANDARD_ERROR_OF_MEAN|0.392|||TWO_SIDED|95.0|2.3395|3.9187|||||Perfect dose proportionality would correspond to a slope of 1. Standard error of mean is actually standard error of slope.|Dose proportionality was explored using the power model. Dose proportionality of BI 655064 was to be assessed based on the exposure parameter AUC0-tz, determined for the 4 subcutaneous dose levels. This analysis is for the overall population.||3.9187|2.3395|
72575967|NCT02618759|144678413|SUPERIORITY|||||||0.0745|||||||Cochran-Mantel-Haenszel|||||||0.0745
72541603|NCT03751124|144612975|OTHER|Chi-square test was used for the comparison between relugolix plus E2/NETA group and placebo group.|Treatment difference|63.36|||<|0.0001|TWO_SIDED|95.0|52.85|73.86||P-value was based on the stratified test statistics via log-log transformation of the difference in survival curve at a fixed time point stratified by pivotal study baseline MBL volume and duration of prior exposure to relugolix.|Log-Log transformation|Log-Log transformation of survival curve based on stratified Kaplan-Meier analysis|The 95% confidence interval (CI) of treatment difference was calculated via linear transformation of the difference in survival function with pooled variance.|The primary efficacy analysis was the comparison of the relugolix plus E2/NETA group with the placebo group with respect to responder rate.||73.86|52.85|<0.0001
72575968|NCT02618759|144678414|SUPERIORITY|||||||0.231|||||||Cochran-Mantel-Haenszel|||||||0.2310
72575969|NCT02618759|144678415|SUPERIORITY|||||||0.1059|||||||Cochran-Mantel-Haenszel|||||||0.1059
72575970|NCT02618759|144678416|SUPERIORITY|||||||0.6962|||||||Cochran-Mantel-Haenszel|||||||0.6962
72575971|NCT02618759|144678417|SUPERIORITY|||||||1|||||||Cochran-Mantel-Haenszel|||||||1.0000
72575972|NCT02618759|144678418|SUPERIORITY|||||||0.1044|||||||Cochran-Mantel-Haenszel|||||||0.1044
72575973|NCT02932306|144678424|SUPERIORITY||||||<|0.001||||||Threshold for significance at 0.05.|ANCOVA|||Analysis was performed using analysis of covariance (ANCOVA) with factors of treatment group and analysis center and the respective baseline lesion count as a covariate.||||<0.001
72575974|NCT02932306|144678425|SUPERIORITY||||||<|0.001||||||Threshold for significance at 0.05.|ANCOVA|||Analysis was performed using ANCOVA with factors of treatment group and analysis center and the respective baseline lesion count as a covariate.||||<0.001
72575975|NCT02932306|144678426|SUPERIORITY||||||<|0.001||||||Threshold for significance at 0.05.|Regression, Logistic|||Analysis was performed using a logistic regression test (using Firth's Penalized Likelihood) with factors of treatment group and analysis center.||||<0.001
72575976|NCT00605540|144678431|SUPERIORITY_OR_OTHER|||||||0.09||95.0|||||Wilcoxon (Mann-Whitney)|||All data were analyzed using SigmaStat 3.2 (Inc., USA) software. Mean ± SD or median interquartile range (25-75%) was used depending on the data distribution. Wilcoxon test was applied to compare the characteristics at baseline to those observed after 3 years.||||0.09
72575977|NCT00843479|144678436|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.07||||0.001|||||||Wilcoxon (Mann-Whitney)|||||||0.001
72575978|NCT00843479|144678437|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.25||||0.001||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.001
72575979|NCT00843479|144678438|SUPERIORITY_OR_OTHER|||||||0.01||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.01
72575980|NCT00843479|144678439|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||Wilcoxon (Mann-Whitney)|||||||>0.05
72575981|NCT00843479|144678440|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||Wilcoxon (Mann-Whitney)|||||||>0.05
72575982|NCT00843479|144678441|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||Wilcoxon (Mann-Whitney)|||||||>0.05
72575983|NCT01544179|144678442|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.86||||0.273|TWO_SIDED|95.0|0.65|1.13|||Cox Proportional Hazards|||||1.13|0.65|0.273
72575984|NCT01544179|144678445|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.62||||0.029|TWO_SIDED|95.0|1.05|2.52|||Cox Proportional Hazards|||||2.52|1.05|0.029
72541604|NCT03751124|144612976|OTHER|Stratified log-rank test was used for the comparison between relugolix plus E2/NETA group and placebo group.|Hazard Ratio (HR)|0.13|||<|0.0001|TWO_SIDED|95.0|0.08|0.2||P-value for comparison of relugolix plus E2/NETA to placebo was based on the stratified log-rank test.|Log Rank||Hazard ratio (95% CI) of relugolix plus E2/NETA to placebo was based on a proportional hazard model stratified by pivotal study baseline MBL volume (\<225 mL or ≥225 mL) and duration of prior exposure to relugolix (28 weeks or 52 weeks).|||0.20|0.08|<0.0001
72410028|NCT00153101|144328468|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.93||||0.1251||95.0|0.84|1.02|||Regression, Cox|||||1.02|0.84|0.1251
72541605|NCT03751124|144612977|OTHER|Chi-square test was used for the comparison between relugolix plus E2/NETA group and placebo group.|Treatment difference|58.04|||<|0.0001|TWO_SIDED|95.0|46.97|69.11||P-value was based on the stratified test statistics via log-log transformation of the difference in survival curve at a fixed time point stratified by pivotal study baseline MBL volume and duration of prior exposure to relugolix.|Log-Log transformation|Log-Log transformation of survival curve based on stratified Kaplan-Meier analysis|The 95% CI of treatment difference was calculated via linear transformation of the difference in survival function with pooled variance.|||69.11|46.97|<0.0001
72541606|NCT03751124|144612978|SUPERIORITY||Treatment difference|44.12|||<|0.0001|TWO_SIDED|95.0|33.13|55.11||P-value for difference between relugolix plus E2/NETA and placebo is based on Cochran-Mantel-Haenszel test stratified by pivotal study baseline MBL volume (\<225 mL or ≥225 mL) and duration of prior exposure to relugolix (28 weeks or 52 weeks).|Cochran-Mantel-Haenszel||Treatment difference is relugolix plus E2/NETA minus placebo. 95% CI for difference is based on the normal approximation.|||55.11|33.13|<0.0001
72541607|NCT00948025|144613048|OTHER|Mann-Whitney U test was used to derive p-values.||||||0.0433||||||"1. a priori threshold for statistical significance set at p\<0.05.~2. the p-value was not adjusted for multiple comparisons."|Wilcoxon (Mann-Whitney)|||"1. P-value comparing static 2-point discrimination per visit derived from mixed linear modeling of longitudinal data.~2. P-Value is based on Mann-Whitney U test."||||0.0433
72541608|NCT03182920|144613086|SUPERIORITY||Ratio of geometric least squares means|1.21|||||TWO_SIDED|90.0|0.962|1.52||||||||1.52|0.962|
72541609|NCT03182920|144613087|SUPERIORITY||Ratio of geometric least squares means|1.26|||||TWO_SIDED|90.0|1.03|1.55||||||||1.55|1.03|
72541610|NCT02082912|144613091|SUPERIORITY||F statistic|0.216||||0.651|TWO_SIDED||||||ANOVA|||Values represent the time x treatment group interaction.||||0.651
72541611|NCT02082912|144613092|SUPERIORITY||F statistic|0.633||||0.447|TWO_SIDED||||||ANOVA|||Values represent the time x treatment group interaction.||||0.447
72541612|NCT02082912|144613093|SUPERIORITY||F statistic|0.557||||0.471|TWO_SIDED||||||ANOVA|||Values represent the time x treatment group interaction.||||0.471
72541613|NCT00782275|144613104|SUPERIORITY|||||||0.081|||||||exact binomial test|||The regimen was evaluated against an historical control with null and alternative 4-month PFS rates of 50% and 70%, respectively. With the final sample size of 40 eligible patients and using the same operating characteristics (alpha and beta 10%), the decision rule changes such that if 25 or more patients of 40 are alive and progression-free at 4 months then this regimen is considered promising.||||0.081
72541614|NCT00289731|144613113|NON_INFERIORITY|Non-inferiority was defined as the lower limit of the 95% CI for the difference between the two treatment groups (Twinrix Group minus Engerix-B+Havrix Group), in terms of seropositivity rates for anti-HAV antibody, being - 10%.|Difference in seropositivity rate|-1.66|||||TWO_SIDED|95.0|-5.34|1.48||||||Difference in seropositivity rates against hepatitis A virus (HAV) antigen: To demonstrate that the immunogenicity of Twinrix vaccine (Twinrix Group) administered at Months 0, 1 and 6 was non-inferior to that of separately administered monovalent vaccines Engerix-B at Months 0, 1 and 6 and Havrix at Months 0 and 6 (Engerix-B+Havrix Group), in terms of anti-HAV seropositivity rates, at Month 7.||1.48|-5.34|
72541615|NCT00289731|144613113|NON_INFERIORITY|Non-inferiority was defined as the lower limit of the 95% CI for the difference between the two treatment groups (Twinrix Group minus HB VAX PRO+Vaqta Group), in terms of seropositivity rates for anti-HAV antibody, being - 10%.|Difference in seropositivity rate|-1.63|||||TWO_SIDED|95.0|-5.31|1.6||||||Difference in seropositivity rates against hepatitis A virus (HAV) antigen: To demonstrate that the immunogenicity of Twinrix vaccine (Twinrix Group) administered at Months 0, 1 and 6 was non-inferior to that of separately administered monovalent vaccines HB VAX PRO at Months 0, 1 and 6 and Vaqta at Months 0 and 6 (HB VAX PRO+Vaqta Group), in terms of anti-HAV seropositivity rates, at Month 7.||1.60|-5.31|
72541616|NCT00289731|144613114|NON_INFERIORITY|Non-inferiority was defined as the lower limit of the 95% CI for the difference between the two treatment groups (Twinrix Group minus Engerix-B+Havrix Group), in terms of seroprotection rates for anti-HBs antibody, being - 10%.|Difference in seroprotection rate|12.04|||||TWO_SIDED|95.0|4.97|19.35||||||Difference in seroprotection rates against hepatitis B surface (HBs) antigen: To demonstrate that the immunogenicity of Twinrix vaccine (Twinrix Group) administered at Months 0, 1 and 6 was non-inferior to that of separately administered monovalent vaccines Engerix-B at Months 0, 1 and 6 and Havrix at Months 0 and 6 (Engerix-B+Havrix Group), in terms of anti-HBs seroprotection rates, at Month 7.||19.35|4.97|
72541617|NCT00289731|144613114|NON_INFERIORITY|Non-inferiority was defined as the lower limit of the 95% CI for the difference between the two treatment groups (Twinrix Group minus HB VAX PRO+Vaqta Group), in terms of seroprotection rates for anti-HBs antibody, being - 15%.|Difference in seroprotection rates|20.69|||||TWO_SIDED|95.0|12.92|28.62||||||Difference in seropositivity rates against hepatitis B surface (HBs) antigen: To demonstrate that the immunogenicity of Twinrix vaccine (Twinrix Group) administered at Months 0, 1 and 6 was non-inferior to that of separately administered monovalent vaccines HB VAX PRO at Months 0, 1 and 6 and Vaqta at Months 0 and 6 (HB VAX PRO+Vaqta Group), in terms of anti-HBs seroprotection rates, at Month 7.||28.62|12.92|
72541618|NCT00747747|144613147|SUPERIORITY_OR_OTHER||Frequency|0.0|||<|0.05|||||||Chi-squared|||Null hypothesis: no difference among groups.||||<0.05
72541619|NCT00747747|144613152|SUPERIORITY_OR_OTHER||Frequency|0.0|||<|0.05|||||||Chi-squared|||Null hypotheis: no difference among the groups.||||<0.05
72410029|NCT00153101|144328469|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.81||||0.0213||95.0|0.67|0.97|||Regression, Cox|||||0.97|0.67|0.0213
72410030|NCT00153101|144328469|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.9||||0.2396||95.0|0.75|1.07|||Regression, Cox|||||1.07|0.75|0.2396
72410031|NCT00153101|144328470|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.9||||0.0111||95.0|0.83|0.98|||Regression, Cox|||||0.98|0.83|0.0111
72541620|NCT02314520|144613167|SUPERIORITY|||||||0.271||||||0.05 is the threshold for significance for this primary outcome.|Fisher Exact|||||||0.271
72541621|NCT00467818|144613171|SUPERIORITY_OR_OTHER_LEGACY|||||||1|||||||t-test, 2 sided|||||||1.0
72541622|NCT00467818|144613172|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.1|TWO_SIDED||||||Mixed Models Analysis|||||||0.10
72541623|NCT00467818|144613174|SUPERIORITY||Mean Difference (Final Values)|0.5|||<|0.5|TWO_SIDED||||||Mixed Models Analysis|||||||<0.5
72541624|NCT00467818|144613175|SUPERIORITY||Mean Difference (Final Values)|0.5||||0.5|TWO_SIDED||||||Mixed Models Analysis|||||||0.5
72541625|NCT02143947|144613189|SUPERIORITY_OR_OTHER||||||>|0.1|TWO_SIDED||||||Mixed Models Analysis|||||||> .10
72541626|NCT02143947|144613190|SUPERIORITY_OR_OTHER||||||=|0.036|TWO_SIDED||||||Mixed Models Analysis|||||||= .036
72541627|NCT02143947|144613191|SUPERIORITY_OR_OTHER||||||>|0.1|TWO_SIDED||||||Mixed Models Analysis|||||||> .10
72541628|NCT02143947|144613192|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Mixed Models Analysis|||||||< .05
72541629|NCT01244815|144613193|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares (LS) Means|-3.2||||0.008|TWO_SIDED|95.0|-5.6|-0.8||p-value is adjusted by Hochberg's method for testing three asenapine groups versus the placebo group|Mixed Model for Repeated Measures (MMRM)|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 98, asenapine 2.5 mg - 101, asenapine 5.0 mg - 98, asenapine 10.0 mg - 98)||-0.8|-5.6|0.008
72541630|NCT01244815|144613193|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-5.3|||<|0.001|TWO_SIDED|95.0|-7.7|-2.9||p-value is adjusted by Hochberg's method for testing three asenapine groups versus the placebo group|MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 98, asenapine 2.5 mg - 101, asenapine 5.0 mg - 98, asenapine 10.0 mg - 98)||-2.9|-7.7|<0.001
72541631|NCT01244815|144613193|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-6.2|||<|0.001|TWO_SIDED|95.0|-8.6|-3.8||p-value is adjusted by Hochberg's method for testing three asenapine groups versus the placebo group|MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 98, asenapine 2.5 mg - 101, asenapine 5.0 mg - 98, asenapine 10.0 mg - 98)||-3.8|-8.6|<0.001
72541632|NCT01244815|144613193|SUPERIORITY_OR_OTHER_LEGACY||t-statistic|-4.92|||<|0.0001||||||p-value (adjusted to control Type I error in multiple testing) for dose-response pattern 1 (Placebo\<2.5 mg=5.0 mg=10.0 mg)|MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|t-statistic associated with the contrast of the MMRM model for dose-response pattern 1. Lower value indicates pattern provides better fit to data.|Investigation of dose-response relationship of change from baseline to Day 21 in Y-MRS total score was a Secondary study endpoint. Multiple contrast testing using MMRM model (FAS population) was used to evaluate 7 pre-defined dose-response patterns.||||<0.0001
72541633|NCT01244815|144613193|SUPERIORITY_OR_OTHER_LEGACY||t-statistic|-4.87|||<|0.0001||||||p-value (adjusted to control Type I error in multiple testing) for dose-response pattern 2 (Placebo=2.5 mg\<5.0 mg=10.0 mg)|MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|t-statistic associated with the contrast of the MMRM model for dose-response pattern 2. Lower value indicates pattern provides better fit to data.|Investigation of dose-response relationship of change from baseline to Day 21 in Y-MRS total score was a Secondary study endpoint. Multiple contrast testing using MMRM model (FAS population) was used to evaluate 7 pre-defined dose-response patterns.||||<0.0001
72410032|NCT00153101|144328470|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.92||||0.0606||95.0|0.85|1.0|||Regression, Cox|||||1.00|0.85|0.0606
72410033|NCT00153101|144328471|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.19||||0.0082||95.0|1.05|1.35|||Regression, Cox|||||1.35|1.05|0.0082
72541634|NCT01244815|144613193|SUPERIORITY_OR_OTHER_LEGACY||t-statistic|-3.4||||0.0021||||||p-value (adjusted to control Type I error in multiple testing) for dose-response pattern 3 (Placebo=2.5 mg=5.0 mg\<10.0 mg)|MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|t-statistic associated with the contrast of the MMRM model for dose-response pattern 3. Lower value indicates pattern provides better fit to data.|Investigation of dose-response relationship of change from baseline to Day 21 in Y-MRS total score was a Secondary study endpoint. Multiple contrast testing using MMRM model (FAS population) was used to evaluate 7 pre-defined dose-response patterns.||||0.0021
72575985|NCT01544179|144678446|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.92||||0.76|TWO_SIDED|95.0|0.55|1.55|||Regression, Logistic|||||1.55|0.55|0.760
72575986|NCT01544179|144678447|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.39||||0.308|TWO_SIDED|95.0|0.74|2.62|||Regression, Logistic|||||2.62|0.74|0.308
72410034|NCT00153101|144328471|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.08||||0.2164||95.0|0.95|1.23|||Regression, Cox|||||1.23|0.95|0.2164
72410035|NCT00153101|144328472|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.94||||0.3732||95.0|0.83|1.07|||Regression, Cox|||||1.07|0.83|0.3732
72410036|NCT00153101|144328472|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.06||||0.3633||95.0|0.94|1.2|||Regression, Cox|||||1.20|0.94|0.3633
72410037|NCT00153101|144328473|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.04||||0.2713||95.0|0.97|1.13|||Regression, Cox|||||1.13|0.97|0.2713
72410038|NCT00153101|144328473|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.03||||0.515||95.0|0.95|1.11|||Regression, Cox|||||1.11|0.95|0.5150
72410039|NCT00153101|144328474|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.92||||0.3485||95.0|0.77|1.1|||Regression, Cox|||for subjects without diabetes at baseline||1.10|0.77|0.3485
72541635|NCT01244815|144613193|SUPERIORITY_OR_OTHER_LEGACY||t-statistic|-5.28|||<|0.0001||||||p-value (adjusted to control Type I error in multiple testing) for dose-response pattern 4 (Placebo\<2.5 mg\<5.0 mg\<10.0 mg)|MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|t-statistic associated with the contrast of the MMRM model for dose-response pattern 4. Lower value indicates pattern provides better fit to data.|Investigation of dose-response relationship of change from baseline to Day 21 in Y-MRS total score was a Secondary study endpoint. Multiple contrast testing using MMRM model (FAS population) was used to evaluate 7 pre-defined dose-response patterns.||||<0.0001
72541636|NCT01244815|144613193|SUPERIORITY_OR_OTHER_LEGACY||t-statistic|-4.64|||<|0.0001||||||p-value (adjusted to control Type I error in multiple testing) for dose-response pattern 5 (Placebo=2.5 mg\<5.0 mg\<10.0 mg)|MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|t-statistic associated with the contrast of the MMRM model for dose-response pattern 5. Lower value indicates pattern provides better fit to data.|Investigation of dose-response relationship of change from baseline to Day 21 in Y-MRS total score was a Secondary study endpoint. Multiple contrast testing using MMRM model (FAS population) was used to evaluate 7 pre-defined dose-response patterns.||||<0.0001
72410040|NCT00153101|144328474|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.14||||0.1235||95.0|0.96|1.36|||Regression, Cox|||for subjects without diabetes at baseline||1.36|0.96|0.1235
72541637|NCT01244815|144613193|SUPERIORITY_OR_OTHER_LEGACY||t-statistic|-5.07|||<|0.0001||||||p-value (adjusted to control Type I error in multiple testing) for dose-response pattern 6 (Placebo\<2.5 mg=5.0 mg\<10.0 mg)|MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|t-statistic associated with the contrast of the MMRM model for dose-response pattern 6. Lower value indicates pattern provides better fit to data.|Investigation of dose-response relationship of change from baseline to Day 21 in Y-MRS total score was a Secondary study endpoint. Multiple contrast testing using MMRM model (FAS population) was used to evaluate 7 pre-defined dose-response patterns.||||<0.0001
72541638|NCT01244815|144613193|SUPERIORITY_OR_OTHER_LEGACY||t-statistic|-5.49|||<|0.0001||||||p-value (adjusted to control Type I error in multiple testing) for dose-response pattern 7 (Placebo\<2.5 mg\<5.0 mg=10.0 mg)|MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|t-statistic associated with the contrast of the MMRM model for dose-response pattern 7. Lower value indicates pattern provides better fit to data.|Investigation of dose-response relationship of change from baseline to Day 21 in Y-MRS total score was a Secondary study endpoint. Multiple contrast testing using MMRM model (FAS population) was used to evaluate 7 pre-defined dose-response patterns.||||<0.0001
72541639|NCT01244815|144613194|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.6|||<|0.001|TWO_SIDED|95.0|-0.9|-0.3||p-value is adjusted by Hochberg's method for testing three asenapine groups versus the placebo group|MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 98, asenapine 2.5 mg - 101, asenapine 5.0 mg - 98, asenapine 10.0 mg - 98)||-0.3|-0.9|<0.001
72541640|NCT01244815|144613194|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.7|||<|0.001|TWO_SIDED|95.0|-0.9|-0.4||p-value is adjusted by Hochberg's method for testing three asenapine groups versus the placebo group|MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 98, asenapine 2.5 mg - 101, asenapine 5.0 mg - 98, asenapine 10.0 mg - 98)||-0.4|-0.9|<0.001
72541641|NCT01244815|144613194|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.7|||<|0.001|TWO_SIDED|95.0|-1.0|-0.4||p-value is adjusted by Hochberg's method for testing three asenapine groups versus the placebo group|MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 98, asenapine 2.5 mg - 101, asenapine 5.0 mg - 98, asenapine 10.0 mg - 98)||-0.4|-1.0|<0.001
72575987|NCT01544179|144678448|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.92||||0.77|TWO_SIDED|95.0|0.53|1.59|||Regression, Logistic|||||1.59|0.53|0.770
72575988|NCT01544179|144678449|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.91||||0.507|TWO_SIDED|95.0|0.68|1.21|||Cox Proportional Hazards|||||1.21|0.68|0.507
72575989|NCT01544179|144678450|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.91||||0.725|TWO_SIDED|95.0|0.54|1.53|||Regression, Logistic|||||1.53|0.54|0.725
72575990|NCT01544179|144678451|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.92||||0.575|TWO_SIDED|95.0|0.69|1.23|||Cox Proportional Hazards|||||1.23|0.69|0.575
72575991|NCT01544179|144678452|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.01||||0.959|TWO_SIDED|95.0|0.61|1.68|||Regression, Logistic|||||1.68|0.61|0.959
72575992|NCT01544179|144678453|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.89||||0.437|TWO_SIDED|95.0|0.66|1.2|||Cox Proportional Hazards|||||1.20|0.66|0.437
72575993|NCT00049530|144678454|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||bionomial proportion test|||It is of interest to test the null hypothesis of 10% plasma b-FGF response rate versus the alternative hypothesis of 30% response rate. Based on the sample size of 30 eligible patients, there will be 84% power to detect this 20% difference in b-FGF response rates. This was based on a two-sided type I error of .05, using the one-sample binomial test.||||<0.001
72575994|NCT03857750|144678474|OTHER||Mean Difference (Final Values)|82.0|||<|0.001|TWO_SIDED|95.0|40.0|124.0|||t-test, 2 sided|||Comparing onset time of rocuronium||124|40|<0.001
72575995|NCT03857750|144678474|OTHER||Odds|19.48|||<|0.001|TWO_SIDED|95.0|||||Wilcoxon Mann-Whitney odd||95 % confidence interval is 7.63 to infinity|82||||<0.001
72575996|NCT03857750|144678476|OTHER||Mean Difference (Final Values)|31.0|||<|0.001|TWO_SIDED|95.0|14.0|48.0|||t-test, 2 sided|||Comparing duration of action of rocuronium||48|14|<0.001
72575997|NCT03857750|144678476|OTHER||Odds|6.35||||0.001|TWO_SIDED||||||Wilcoxon Mann-Whitney odd||95% Confidence interval is 2.59 to infinity.|Comparing duration of action of rocuronium||||0.001
72410041|NCT00153101|144328475|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.99||||0.869||95.0|0.89|1.11|||Chi-squared|||for subjects with available Mini Mental State Examination (MMSE) at baseline||1.11|0.89|0.8690
72410042|NCT00153101|144328475|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.04||||0.4337||95.0|0.94|1.17|||Chi-squared|||for subjects with available Mini Mental State Examination (MMSE) at baseline||1.17|0.94|0.4337
72410043|NCT00153101|144328476|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.94||||0.2666||95.0|0.83|1.05|||Regression, Cox|||for subjects without atrial fibrillation at baseline||1.05|0.83|0.2666
72575998|NCT01696058|144678477|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.106|STANDARD_ERROR_OF_MEAN|0.014|<|0.0001|TWO_SIDED|95.0|0.078|0.135|||Mixed Model Repeated Measure|||Results are from an mixed model repeated measure (MMRM) model. Fixed effects include treatment, visit, treatment by visit interaction, baseline and baseline by visit interaction. Patient is considered random and an unstructured covariance structure was used. Number of patients contributing to models: Tio+Placebo (566), Tio+Olo 5ug (563).||0.135|0.078|<.0001
72575999|NCT01696058|144678478|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.04|STANDARD_ERROR_OF_MEAN|0.013||0.0029|TWO_SIDED|95.0|0.014|0.065|||Mixed Model Repeated Measure|||Results are from an MMRM model. Fixed effects include treatment, visit, treatment by visit interaction, baseline and baseline by visit interaction. Patient is considered random and an unstructured covariance structure was used. Number of patients contributing to models: Tio+Placebo (555), Tio+Olo 5ug (550).||0.065|0.014|0.0029
72576000|NCT01696058|144678479|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.854|STANDARD_ERROR_OF_MEAN|0.461|<|0.0001|TWO_SIDED|95.0|-2.757|-0.951|||ANCOVA|||"Results are from ANCOVA model. Fixed effects include study, treatment and baseline.~Number of patients contributing to models: Tio+Placebo (1055), Tio+Olo 5ug (1039)."||-0.951|-2.757|<.0001
72576001|NCT01696058|144678480|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.015|<|0.0001|TWO_SIDED|95.0|0.071|0.129|||Mixed Model Repeated Measure|||"Results are from an MMRM model. Fixed effects include treatment, visit, treatment by visit interaction, baseline and baseline by visit interaction. Patient is considered random and an unstructured covariance structure was used.~Number of patients contributing to models: Tio+Placebo (566), Tio+Olo 5ug (563)."||0.129|0.071|<.0001
72576002|NCT01696058|144678481|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.118|STANDARD_ERROR_OF_MEAN|0.023|<|0.0001|TWO_SIDED|95.0|0.072|0.164|||Mixed Model Repeated Measure|||"Results are from an MMRM model. Fixed effects include treatment, visit, treatment by visit interaction, baseline and baseline by visit interaction. Patient is considered random and an unstructured covariance structure was used.~Number of patients contributing to models: Tio+Placebo (566), Tio+Olo 5ug (563)."||0.164|0.072|<.0001
72576003|NCT01696058|144678482|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.104|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001|TWO_SIDED|95.0|0.057|0.152|||Mixed Model Repeated Measure|||"Results are from an MMRM model. Fixed effects include treatment, visit, treatment by visit interaction, baseline and baseline by visit interaction. Patient is considered random and an unstructured covariance structure was used.~Number of patients contributing to models: Tio+Placebo (566), Tio+Olo 5ug (563)."||0.152|0.057|<.0001
72576004|NCT01696058|144678483|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.034|STANDARD_ERROR_OF_MEAN|0.022||0.1156|TWO_SIDED|95.0|-0.008|0.076|||Mixed Model Repeated Measure|||"Results are from an MMRM model. Fixed effects include treatment, visit, treatment by visit interaction, baseline and baseline by visit interaction. Patient is considered random and an unstructured covariance structure was used.~Number of patients contributing to models: Tio+Placebo (555), Tio+Olo 5ug (550)."||0.076|-0.008|0.1156
72576005|NCT01696058|144678484|SUPERIORITY_OR_OTHER||Mean difference from Tio+Placebo Week 12|7.237|STANDARD_ERROR_OF_MEAN|2.145||0.0008|TWO_SIDED|95.0|3.028|11.446|||ANCOVA|||"Week 12: Results are from non-MMRM ANCOVA models by week with LOCF up to each week. Fixed effects include treatment and baseline.~Number of patients contributing to models: Tio+Placebo (559), Tio+Olo 5ug (552)."||11.446|3.028|0.0008
72576006|NCT01696058|144678485|SUPERIORITY_OR_OTHER||Mean difference from Tio+Placebo Week 12|-0.568|STANDARD_ERROR_OF_MEAN|0.118|<|0.0001|TWO_SIDED|95.0|-0.8|-0.336|||ANCOVA|||"Week 12 - Results are from non-MMRM ANCOVA models by week with LOCF up to each week. Fixed effects include treatment and baseline.~Number of patients contributing to models: Tio+Placebo (559), Tio+Olo 5ug (555)."||-0.336|-0.800|<.0001
72576007|NCT01696058|144678486|SUPERIORITY_OR_OTHER||Mean difference from Tio+Placebo Week 1|-0.09|STANDARD_ERROR_OF_MEAN|0.045||0.0467|TWO_SIDED|95.0|-0.178|-0.001|||ANCOVA|||"Week 12 - Results are from non-MMRM ANCOVA models by week with LOCF up to each week. Fixed effects include treatment and baseline.~Number of patients contributing to models: Tio+Placebo (559), Tio+Olo 5ug (555)."||-0.001|-0.178|0.0467
72627836|NCT00565409|144783963|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.11||||0.5511|TWO_SIDED|95.0|0.7|1.7||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 40||1.7|0.7|0.5511
72410044|NCT00153101|144328476|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.96||||0.4784||95.0|0.85|1.08|||Regression, Cox|||for subjects without atrial fibrillation at baseline||1.08|0.85|0.4784
72627837|NCT00565409|144783963|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.92||||0.0013|TWO_SIDED|95.0|1.3|2.9||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 40||2.9|1.3|0.0013
72627838|NCT00565409|144783963|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.79|||<|0.0001|TWO_SIDED|95.0|1.8|4.3||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 48||4.3|1.8|<0.0001
72627839|NCT00565409|144783963|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.97||||0.9225|TWO_SIDED|95.0|0.6|1.5||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 48||1.5|0.6|0.9225
72627840|NCT00565409|144783963|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.95|||<|0.0001|TWO_SIDED|95.0|1.9|4.5||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 48||4.5|1.9|<0.0001
72627841|NCT00565409|144783963|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.2|||<|0.0001|TWO_SIDED|95.0|2.7|6.6||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 56||6.6|2.7|<0.0001
72410045|NCT00153101|144328477|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.87||||0.0483||95.0|0.76|1.0|||Regression, Cox|||||1.00|0.76|0.0483
72410046|NCT00153101|144328478|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.92||||0.2192||95.0|0.81|1.05|||Regression, Cox|||||1.05|0.81|0.2192
72410047|NCT00153101|144328479|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.03||||0.7764||95.0|0.85|1.24|||Regression, Cox|||||1.24|0.85|0.7764
72541642|NCT01244815|144613195|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|3.0||||0.018|TWO_SIDED|95.0|1.2|7.6||95% Confidence Interval and p-value are based on Wald statistic|Regression, Logistic|Model included terms of treatment and baseline Y-MRS total score|OR was adjusted for baseline. An OR of \>1 is considered to mean that asenapine has a higher probability of achieving Total Y-MRS 50% response.|Analysis is for asenapine versus placebo on Day 4 (LOCF)||7.6|1.2|0.018
72541643|NCT01244815|144613195|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|3.4||||0.008|TWO_SIDED|95.0|1.4|8.6||95% Confidence Interval and p-value are based on Wald statistic|Regression, Logistic|Model included terms of treatment and baseline Y-MRS total score|OR was adjusted for baseline. An OR of \>1 is considered to mean that asenapine has a higher probability of achieving Total Y-MRS 50% response.|Analysis is for asenapine versus placebo on Day 4 (LOCF)||8.6|1.4|0.008
72541644|NCT01244815|144613195|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.1||||0.129|TWO_SIDED|95.0|0.8|5.6||95% Confidence Interval and p-value are based on Wald statistic|Regression, Logistic|Model included terms of treatment and baseline Y-MRS total score|OR was adjusted for baseline. An OR of \>1 is considered to mean that asenapine has a higher probability of achieving Total Y-MRS 50% response.|Analysis is for asenapine versus placebo on Day 4 (LOCF)||5.6|0.8|0.129
72541645|NCT01244815|144613195|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.9||||0.003|TWO_SIDED|95.0|1.4|5.9||95% Confidence Interval and p-value are based on Wald statistic|Regression, Logistic|Model included terms of treatment and baseline Y-MRS total score|OR was adjusted for baseline. An OR of \>1 is considered to mean that asenapine has a higher probability of achieving Total Y-MRS 50% response.|Analysis is for asenapine versus placebo on Day 7 (LOCF)||5.9|1.4|0.003
72541646|NCT01244815|144613195|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.8||||0.005|TWO_SIDED|95.0|1.4|5.6||95% Confidence Interval and p-value are based on Wald statistic|Regression, Logistic|Model included terms of treatment and baseline Y-MRS total score|OR was adjusted for baseline. An OR of \>1 is considered to mean that asenapine has a higher probability of achieving Total Y-MRS 50% response.|Analysis is for asenapine versus placebo on Day 7 (LOCF)||5.6|1.4|0.005
72541647|NCT01244815|144613195|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|3.6|||<|0.001|TWO_SIDED|95.0|1.8|7.3||95% Confidence Interval and p-value are based on Wald statistic|Regression, Logistic|Model included terms of treatment and baseline Y-MRS total score|OR was adjusted for baseline. An OR of \>1 is considered to mean that asenapine has a higher probability of achieving Total Y-MRS 50% response.|Analysis is for asenapine versus placebo on Day 7 (LOCF)||7.3|1.8|<0.001
72541648|NCT01244815|144613195|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.2||||0.018|TWO_SIDED|95.0|1.1|4.1||95% Confidence Interval and p-value are based on Wald statistic|Regression, Logistic|Model included terms of treatment and baseline Y-MRS total score|OR was adjusted for baseline. An OR of \>1 is considered to mean that asenapine has a higher probability of achieving Total Y-MRS 50% response.|Analysis is for asenapine versus placebo on Day 14 (LOCF)||4.1|1.1|0.018
72541649|NCT01244815|144613195|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|4.1|||<|0.001|TWO_SIDED|95.0|2.2|7.6||95% Confidence Interval and p-value are based on Wald statistic|Regression, Logistic|Model included terms of treatment and baseline Y-MRS total score|OR was adjusted for baseline. An OR of \>1 is considered to mean that asenapine has a higher probability of achieving Total Y-MRS 50% response.|Analysis is for asenapine versus placebo on Day 14 (LOCF)||7.6|2.2|<0.001
72541650|NCT01244815|144613195|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|4.1|||<|0.001|TWO_SIDED|95.0|2.2|7.6|||Regression, Logistic|Model included terms of treatment and baseline Y-MRS total score|OR was adjusted for baseline. An OR of \>1 is considered to mean that asenapine has a higher probability of achieving Total Y-MRS 50% response.|Analysis is for asenapine versus placebo on Day 14 (LOCF)||7.6|2.2|<0.001
72541651|NCT01244815|144613195|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.9||||0.042|TWO_SIDED|95.0|1.0|3.4||95% Confidence Interval and p-value are based on Wald statistic|Regression, Logistic|Model included terms of treatment and baseline Y-MRS total score|OR was adjusted for baseline. An OR of \>1 is considered to mean that asenapine has a higher probability of achieving Total Y-MRS 50% response.|Analysis is for asenapine versus placebo on Day 21 (LOCF)||3.4|1.0|0.042
72541652|NCT01244815|144613195|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|3.2|||<|0.001|TWO_SIDED|95.0|1.7|5.8||95% Confidence Interval and p-value are based on Wald statistic|Regression, Logistic|Model included terms of treatment and baseline Y-MRS total score|OR was adjusted for baseline. An OR of \>1 is considered to mean that asenapine has a higher probability of achieving Total Y-MRS 50% response.|Analysis is for asenapine versus placebo on Day 21 (LOCF)||5.8|1.7|<0.001
72541653|NCT01244815|144613195|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.9|||<|0.001||95.0|1.6|5.3||95% Confidence Interval and p-value are based on Wald statistic|Regression, Logistic|Model included terms of treatment and baseline Y-MRS total score|OR was adjusted for baseline. An OR of \>1 is considered to mean that asenapine has a higher probability of achieving Total Y-MRS 50% response.|Analysis is for asenapine versus placebo on Day 21 (LOCF)||5.3|1.6|<0.001
72541654|NCT01244815|144613196|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.25||||0.014|TWO_SIDED|95.0|-0.45|-0.05|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 98, asenapine 2.5 mg - 101, asenapine 5.0 mg - 98, asenapine 10.0 mg - 98)||-0.05|-0.45|0.014
72541655|NCT01244815|144613196|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.17||||0.107|TWO_SIDED|95.0|-0.37|0.04|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 98, asenapine 2.5 mg - 101, asenapine 5.0 mg - 98, asenapine 10.0 mg - 98)||0.04|-0.37|0.107
72576008|NCT01696058|144678487|SUPERIORITY_OR_OTHER||Mean difference from Tio+Placebo Week 12|-0.483|STANDARD_ERROR_OF_MEAN|0.094|<|0.0001|TWO_SIDED|95.0|-0.668|-0.298|||ANCOVA|||"Week 12 - Results are from non-MMRM ANCOVA models by week with LOCF up to each week. Fixed effects include treatment and baseline.~Number of patients contributing to models: Tio+Placebo (559), Tio+Olo 5ug (555)."||-0.298|-0.668|<.0001
72410048|NCT00153101|144328480|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.79||||0.0574||95.0|0.62|1.01|||Regression, Cox|||||1.01|0.62|0.0574
72410049|NCT00153101|144328481|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.83||||0.1365||95.0|0.64|1.06|||Regression, Cox|||||1.06|0.64|0.1365
72541656|NCT01244815|144613196|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.21||||0.039|TWO_SIDED|95.0|-0.42|-0.01|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 98, asenapine 2.5 mg - 101, asenapine 5.0 mg - 98, asenapine 10.0 mg - 98)||-0.01|-0.42|0.039
72576009|NCT01934335|144678491|SUPERIORITY|||||||0.51|||||||t-test, 2 sided|||||||0.51
72576010|NCT01934335|144678492|SUPERIORITY|||||||0.35|||||||t-test, 2 sided|||||||0.35
72576011|NCT01934335|144678493|SUPERIORITY|||||||0.43|||||||t-test, 2 sided|||||||0.43
72576012|NCT05384171|144678497|SUPERIORITY||Partial Eta Squared (effect size)|0.02||||0.617|TWO_SIDED||||||ANCOVA|||||||.617
72576013|NCT05384171|144678499|SUPERIORITY||Partial Eta Squared (effect size)|0.089||||0.214|TWO_SIDED||||||ANCOVA|||Null hypothesis: Intervention and active control group intention follow-up means are equal when controlling for covariates (i.e., baseline intention scores and age)||||.214
72410050|NCT00153101|144328482|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.05||||0.694||95.0|0.82|1.34|||Regression, Cox|||||1.34|0.82|0.6940
72410051|NCT00153101|144328483|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.58||||0.0245||95.0|1.06|2.35|||Regression, Cox|||||2.35|1.06|0.0245
72410052|NCT00153101|144328484|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.8||||0.5798||95.0|0.36|1.76|||Regression, Cox|||||1.76|0.36|0.5798
72541657|NCT01244815|144613197|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.33||||0.006|TWO_SIDED|95.0|-0.56|-0.1|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 98, asenapine 2.5 mg - 101, asenapine 5.0 mg - 98, asenapine 10.0 mg - 98)||-0.10|-0.56|0.006
72541658|NCT01244815|144613197|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.35||||0.003|TWO_SIDED|95.0|-0.59|-0.12|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 98, asenapine 2.5 mg - 101, asenapine 5.0 mg - 98, asenapine 10.0 mg - 98)||-0.12|-0.59|0.003
72541659|NCT01244815|144613197|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.44|||<|0.001|TWO_SIDED|95.0|-0.67|-0.21|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 98, asenapine 2.5 mg - 101, asenapine 5.0 mg - 98, asenapine 10.0 mg - 98)||-0.21|-0.67|<0.001
72541660|NCT01244815|144613198|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.34||||0.011|TWO_SIDED|95.0|-0.61|-0.08|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 98, asenapine 2.5 mg - 101, asenapine 5.0 mg - 98, asenapine 10.0 mg - 98)||-0.08|-0.61|0.011
72541661|NCT01244815|144613198|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.63|||<|0.001|TWO_SIDED|95.0|-0.89|-0.36|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 98, asenapine 2.5 mg - 101, asenapine 5.0 mg - 98, asenapine 10.0 mg - 98)||-0.36|-0.89|<0.001
72541662|NCT01244815|144613198|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.61|||<|0.001|TWO_SIDED|95.0|-0.88|-0.35|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 98, asenapine 2.5 mg - 101, asenapine 5.0 mg - 98, asenapine 10.0 mg - 98)||-0.35|-0.88|<0.001
72576014|NCT05384171|144678499|SUPERIORITY||Partial Eta Squared (effect size)|0.001||||0.894|TWO_SIDED||||||ANCOVA|||Null hypothesis: Intervention and active control group attitude follow-up means are equal when controlling for covariates (i.e., baseline attitude scores and age)||||.894
72576015|NCT05384171|144678499|SUPERIORITY||Partial Eta Squared (Effect Size)|0.053||||0.359|TWO_SIDED||||||ANCOVA|||Null hypothesis: Intervention and active control group social norms follow-up means are equal when controlling for covariates (i.e., baseline social norms scores and age)||||.359
72576016|NCT05384171|144678499|SUPERIORITY||Partial Eta Squared (Effect Size)|0.058||||0.322|TWO_SIDED||||||ANCOVA|||Null hypothesis: Intervention and active control group perceived behavioral control follow-up means are equal when controlling for covariates (i.e., baseline perceived behavioral control scores and age)||||.322
72410053|NCT00153101|144328485|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.76||||0.0006||95.0|0.65|0.89|||Regression, Cox|||||0.89|0.65|0.0006
72410054|NCT00153101|144328486|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.66||||0.0085||95.0|0.48|0.9|||Regression, Cox|||||0.90|0.48|0.0085
72410055|NCT00153101|144328487|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.8||||0.0015||95.0|0.69|0.92|||Regression, Cox|||||0.92|0.69|0.0015
72576017|NCT05384171|144678500|SUPERIORITY||Partial Eta Squared (effect size)|0.001||||0.891|TWO_SIDED||||||ANCOVA|||||||.891
72576018|NCT00106964|144678509|SUPERIORITY_OR_OTHER|||||||0.044|||||||Chi-squared|||||||0.0440
72576019|NCT00106964|144678509|SUPERIORITY_OR_OTHER|||||||0.0157|||||||Chi-squared|||||||0.0157
72576020|NCT00106964|144678513|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.84||||0.5822||95.0|||||Regression, Cox|||||||0.5822
72576021|NCT00106964|144678513|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.05||||0.8698||95.0|||||Regression, Cox|||||||0.8698
72541663|NCT01244815|144613199|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.61|||<|0.001|TWO_SIDED|95.0|-0.9|-0.32|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 98, asenapine 2.5 mg - 101, asenapine 5.0 mg - 98, asenapine 10.0 mg - 98)||-0.32|-0.90|<0.001
72541664|NCT01244815|144613199|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.75|||<|0.001|TWO_SIDED|95.0|-1.04|-0.46|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 98, asenapine 2.5 mg - 101, asenapine 5.0 mg - 98, asenapine 10.0 mg - 98)||-0.46|-1.04|<0.001
72541665|NCT01244815|144613199|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.74|||<|0.001|TWO_SIDED|95.0|-1.03|-0.45|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 98, asenapine 2.5 mg - 101, asenapine 5.0 mg - 98, asenapine 10.0 mg - 98)||-0.45|-1.03|<0.001
72541666|NCT01244815|144613200|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.07||||0.536|TWO_SIDED|95.0|-0.28|0.15|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 98, asenapine 2.5 mg - 101, asenapine 5.0 mg - 98, asenapine 10.0 mg - 98)||0.15|-0.28|0.536
72541667|NCT01244815|144613200|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.03||||0.811|TWO_SIDED|95.0|-0.24|0.19|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 98, asenapine 2.5 mg - 101, asenapine 5.0 mg - 98, asenapine 10.0 mg - 98)||0.19|-0.24|0.811
72541668|NCT01244815|144613200|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|0.07||||0.556|TWO_SIDED|95.0|-0.15|0.28|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 98, asenapine 2.5 mg - 101, asenapine 5.0 mg - 98, asenapine 10.0 mg - 98)||0.28|-0.15|0.556
72541669|NCT01244815|144613201|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.21||||0.053|TWO_SIDED|95.0|-0.42|0.0|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 98, asenapine 2.5 mg - 101, asenapine 5.0 mg - 98, asenapine 10.0 mg - 98)||0.00|-0.42|0.053
72541670|NCT01244815|144613201|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.18||||0.094|TWO_SIDED|95.0|-0.4|0.03|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 98, asenapine 2.5 mg - 101, asenapine 5.0 mg - 98, asenapine 10.0 mg - 98)||0.03|-0.40|0.094
72541671|NCT01244815|144613201|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.15||||0.178|TWO_SIDED|95.0|-0.36|0.07|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 98, asenapine 2.5 mg - 101, asenapine 5.0 mg - 98, asenapine 10.0 mg - 98)||0.07|-0.36|0.178
72576022|NCT00106964|144678514|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.29||||0.0853|TWO_SIDED|95.0|0.07|1.19|||Regression, Logistic||Adjusted odds ratio (OR) Odds ratio depends on CD4 count resulting from interaction. For example, OR=0.29 for CD4 count = 0; OR= 2.91 for CD4 count = 460 (median CD4 count for the evaluable study population).|||1.19|0.07|0.0853
72576023|NCT00106964|144678514|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.99||||0.0244|TWO_SIDED|95.0|1.09|3.63|||Regression, Logistic||Adjusted odds ratio|||3.63|1.09|0.0244
72576024|NCT00168818|144678518|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority Analysis with NI margin 7.7%. This results from the null-hypotheses of non-inferiority testing, where the rate difference has to be below 7.7%. Non-inferiority can only be shown with CI.|Risk Difference (Percentage)|-0.7||||0.5648||95.0|-2.9|1.6||p-value is for superiority testing|Normal approximation|Normal approximation of independent binomial distribution without stratification||Risk difference versus Enoxaparin||1.6|-2.9|0.5648
72576025|NCT00168818|144678518|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority Analysis with NI margin 7.7%. This results from the null-hypotheses of non-inferiority testing, where the rate difference has to be below 7.7%. Non-inferiority can only be shown with CI.|Risk Difference (Percentage)|1.9||||0.1339||95.0|-0.6|4.4||p-value is for superiority testing|Normal approximation|Normal approximation of independent binomial distribution without stratification||Risk difference versus Enoxaparin||4.4|-0.6|0.1339
72576026|NCT00168818|144678519|SUPERIORITY_OR_OTHER||Risk Difference (Percentage)|-0.8||||0.3256||95.0|-2.5|0.8|||Normal approximation|Normal approximation of independent binomial distribution without stratification||Risk difference versus Enoxaparin||0.8|-2.5|0.3256
72576027|NCT00168818|144678519|SUPERIORITY_OR_OTHER||Risk Difference (Percentage)|0.4||||0.7052||95.0|-1.5|2.2|||Normal approximation|Normal approximation of independent binomial distribution without stratification||Risk difference versus Enoxaparin||2.2|-1.5|0.7052
72576028|NCT00168818|144678520|SUPERIORITY_OR_OTHER||Risk Difference (Percentage)|-1.1||||0.1863||95.0|-2.7|0.5|||Normal approximation|Normal approximation of independent binomial distribution without stratification||Risk difference versus Enoxaparin||0.5|-2.7|0.1863
72541672|NCT01244815|144613202|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.08||||0.506|TWO_SIDED|95.0|-0.33|0.16|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 98, asenapine 2.5 mg - 101, asenapine 5.0 mg - 98, asenapine 10.0 mg - 98)||0.16|-0.33|0.506
72541673|NCT01244815|144613202|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.19||||0.131|TWO_SIDED|95.0|-0.43|0.06|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 98, asenapine 2.5 mg - 101, asenapine 5.0 mg - 98, asenapine 10.0 mg - 98)||0.06|-0.43|0.131
72541674|NCT01244815|144613202|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.16||||0.211|TWO_SIDED|95.0|-0.4|0.09|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 98, asenapine 2.5 mg - 101, asenapine 5.0 mg - 98, asenapine 10.0 mg - 98)||0.09|-0.40|0.211
72541675|NCT01244815|144613203|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.23||||0.079|TWO_SIDED|95.0|-0.49|0.03|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 98, asenapine 2.5 mg - 101, asenapine 5.0 mg - 98, asenapine 10.0 mg - 98)||0.03|-0.49|0.079
72541676|NCT01244815|144613203|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.34||||0.01|TWO_SIDED|95.0|-0.6|-0.08|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 98, asenapine 2.5 mg - 101, asenapine 5.0 mg - 98, asenapine 10.0 mg - 98)||-0.08|-0.60|0.010
72541677|NCT01244815|144613203|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.2||||0.139|TWO_SIDED|95.0|-0.46|0.06|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 98, asenapine 2.5 mg - 101, asenapine 5.0 mg - 98, asenapine 10.0 mg - 98)||0.06|-0.46|0.139
72541678|NCT01244815|144613204|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-2.61||||0.004|TWO_SIDED|95.0|-4.38|-0.83|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 98, asenapine 2.5 mg - 101, asenapine 5.0 mg - 98, asenapine 10.0 mg - 98)||-0.83|-4.38|0.004
72541679|NCT01244815|144613204|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-2.17||||0.017|TWO_SIDED|95.0|-3.95|-0.39|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 98, asenapine 2.5 mg - 101, asenapine 5.0 mg - 98, asenapine 10.0 mg - 98)||-0.39|-3.95|0.017
72576029|NCT00168818|144678520|SUPERIORITY_OR_OTHER||Risk Difference (Percentage)|0.3||||0.702||95.0|-1.4|2.1|||Normal approximation|Normal approximation of independent binomial distribution without stratification||Risk difference versus Enoxaparin||2.1|-1.4|0.7020
72541680|NCT01244815|144613204|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-2.16||||0.017|TWO_SIDED|95.0|-3.93|-0.38|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 98, asenapine 2.5 mg - 101, asenapine 5.0 mg - 98, asenapine 10.0 mg - 98)||-0.38|-3.93|0.017
72541681|NCT01244815|144613205|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.79||||0.395|TWO_SIDED|95.0|-2.62|1.04|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 98, asenapine 2.5 mg - 101, asenapine 5.0 mg - 98, asenapine 10.0 mg - 98)||1.04|-2.62|0.395
72541682|NCT01244815|144613205|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-2.44||||0.009|TWO_SIDED|95.0|-4.26|-0.63|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 98, asenapine 2.5 mg - 101, asenapine 5.0 mg - 98, asenapine 10.0 mg - 98)||-0.63|-4.26|0.009
72541683|NCT01244815|144613205|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-1.44||||0.121|TWO_SIDED|95.0|-3.27|0.38|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 98, asenapine 2.5 mg - 101, asenapine 5.0 mg - 98, asenapine 10.0 mg - 98)||0.38|-3.27|0.121
72576030|NCT00168818|144678521|SUPERIORITY_OR_OTHER||Risk Difference (Percentage)|-1.1||||0.3173||95.0|-3.3|1.1|||Normal approximation|Normal approximation of independent binomial distribution without stratification||Risk difference versus Enoxaparin||1.1|-3.3|0.3173
72410056|NCT00153101|144328488|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.39||||0.0101||95.0|1.08|1.79|||Regression, Cox|||||1.79|1.08|0.0101
72410057|NCT00153101|144328489|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.01||||0.9563||95.0|0.82|1.24|||Regression, Cox|||||1.24|0.82|0.9563
72410058|NCT00153101|144328490|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.17||||0.0868||95.0|0.98|1.41|||Chi-squared|||||1.41|0.98|0.0868
72541684|NCT01244815|144613206|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-1.44||||0.135|TWO_SIDED|95.0|-3.33|0.45|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 98, asenapine 2.5 mg - 101, asenapine 5.0 mg - 98, asenapine 10.0 mg - 98)||0.45|-3.33|0.135
72541685|NCT01244815|144613206|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-2.19||||0.023|TWO_SIDED|95.0|-4.08|-0.3|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 98, asenapine 2.5 mg - 101, asenapine 5.0 mg - 98, asenapine 10.0 mg - 98)||-0.30|-4.08|0.023
72541686|NCT01244815|144613206|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-1.28||||0.189|TWO_SIDED|95.0|-3.2|0.63|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 98, asenapine 2.5 mg - 101, asenapine 5.0 mg - 98, asenapine 10.0 mg - 98)||0.63|-3.20|0.189
72541687|NCT01244815|144613207|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|4.29||||0.002|TWO_SIDED|95.0|1.56|7.02|||ANCOVA|Model included terms of (pooled) site, treatment and baseline|Estimate is asenapine versus placebo|||7.02|1.56|0.002
72541688|NCT01244815|144613207|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|6.95|||<|0.001|TWO_SIDED|95.0|4.22|9.68|||ANCOVA|Model included terms of (pooled) site, treatment and baseline|Estimate is asenapine versus placebo|||9.68|4.22|<0.001
72541689|NCT01244815|144613207|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|5.11|||<|0.001|TWO_SIDED|95.0|2.31|7.91|||ANCOVA|Model included terms of (pooled) site, treatment and baseline|Estimate is asenapine versus placebo|||7.91|2.31|<0.001
72541690|NCT01244815|144613208|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|2.24||||0.05|TWO_SIDED|95.0|0.0|4.48|||ANCOVA|Model included terms of (pooled) site, treatment and baseline|Estimate is asenapine versus placebo|||4.48|-0.00|0.050
72541691|NCT01244815|144613208|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|1.35||||0.239|TWO_SIDED|95.0|-0.9|3.59|||ANCOVA|Model included terms of (pooled) site, treatment and baseline|Estimate is asenapine versus placebo|||3.59|-0.90|0.239
72541692|NCT01244815|144613208|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|2.78||||0.018|TWO_SIDED|95.0|0.48|5.08|||ANCOVA|Model included terms of (pooled) site, treatment and baseline|Estimate is asenapine versus placebo|||5.08|0.48|0.018
72541693|NCT01244815|144613209|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|0.39||||0.001|TWO_SIDED|95.0|0.15|0.62|||ANCOVA|Model included terms of (pooled) site, treatment and baseline|Estimate is asenapine versus placebo|||0.62|0.15|0.001
72541694|NCT01244815|144613209|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|0.18||||0.135|TWO_SIDED|95.0|-0.06|0.41|||ANCOVA|Model included terms of (pooled) site, treatment and baseline|Estimate is asenapine versus placebo|||0.41|-0.06|0.135
72541695|NCT01244815|144613209|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|0.25||||0.044|TWO_SIDED|95.0|0.01|0.49|||ANCOVA|Model included terms of (pooled) site, treatment and baseline|Estimate is asenapine versus placebo|||0.49|0.01|0.044
72541696|NCT04126733|144613249|EQUIVALENCE|H0: ORR ≤ 5% versus H1: ORR \>5% The hypothesis was tested by a one-sided exact binomial test, assuming a background response rate for the combination to be at most 5%.|Rate|7.1||||0.2721||95.0|2.4|15.9||The target response rate for the combination treatment was 17%. Using a one-sided exact binomial test at a type-I error of at most 2.5% at least 8 responders out of the 70 patients were needed to achieve significance.|Exact Binomial Test|||||15.9|2.4|0.2721
72541697|NCT02629133|144613263|SUPERIORITY|||||||0.56|||||||Wilcoxon (Mann-Whitney)|||||||0.560
72541698|NCT02629133|144613263|SUPERIORITY|||||||0.76|||||||Wilcoxon (Mann-Whitney)|||Differences between conditions in the change in % heavy drinking/using days from baseline to 6 months||||0.760
72541699|NCT02629133|144613264|SUPERIORITY|||||||0.026|||||||Wilcoxon (Mann-Whitney)|||||||0.026
72541700|NCT02629133|144613264|SUPERIORITY|||||||0.029|||||||Wilcoxon (Mann-Whitney)|||Distributions were badly skewed, and the sample was too small for ZINB or other analyses. Therefore, we analyzed differences between conditions in changes in services/day over time (i.e., from baseline to 6 month post-shelter follow-up) using the Mann-Whitney U.||||0.029
72541701|NCT02629133|144613265|SUPERIORITY||Mean Difference (Final Values)|4.5||||0.325|TWO_SIDED|95.0|-4.5|13.5||We used hierarchical linear modeling (HLM) to predict 3-mo and 6-mo post-shelter scores from treatment condition, using baseline score as a covariate.|Mixed Models Analysis|||||13.5|-4.5|0.325
72541702|NCT02629133|144613266|SUPERIORITY||Mean Difference (Final Values)|1.19||||0.192|TWO_SIDED|95.0|-0.61|2.98||We used HLM to predict Cyber-Stalking Scores across 3 and 6 month post shelter follow-up points from treatment condition, using baseline score as a covariate.|Mixed Models Analysis||Higher scores represent more cyber-stalking over follow-up.|||2.98|-0.61|0.192
72541703|NCT02629133|144613267|SUPERIORITY||Mean Difference (Final Values)|-1.43||||0.119|TWO_SIDED|95.0|-3.24|0.38||We conducted HLM predicting SBC Total scores at 3 and 6 months post-shelter release from treatment condition, using baseline SBC score as a covariate.|Mixed Models Analysis||Higher is better (reflecting more safety behaviors used).|||0.38|-3.24|0.119
72541704|NCT02354976|144613294|OTHER||Geometric mean ratio for difference|0.92||||0.407|TWO_SIDED|95.0|0.76|1.12|||Mixed Models Analysis|||||1.12|0.76|0.407
72541705|NCT02354976|144613295|OTHER||Geometric mean ratio for difference|0.84||||0.077|TWO_SIDED|95.0|0.7|1.02|||Mixed Models Analysis|||||1.02|0.70|0.077
72576031|NCT00168818|144678521|SUPERIORITY_OR_OTHER||Risk Difference (Percentage)|1.9||||0.1274||95.0|-0.5|4.3|||Normal approximation|Normal approximation of independent binomial distribution without stratification||Risk difference versus Enoxaparin||4.3|-0.5|0.1274
72576032|NCT00168818|144678522|SUPERIORITY_OR_OTHER|||||||0.0694||95.0|||||Fisher Exact|||Comparison versus Enoxaparin||||0.0694
72576033|NCT00168818|144678522|SUPERIORITY_OR_OTHER|||||||0.0212||95.0|||||Fisher Exact|||Comparison versus Enoxaparin||||0.0212
72627842|NCT00565409|144783963|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.32||||0.2454|TWO_SIDED|95.0|0.9|2.0||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 56||2.0|0.9|0.2454
72627843|NCT00565409|144783963|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.15|||<|0.0001|TWO_SIDED|95.0|2.0|4.9||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 56||4.9|2.0|<0.0001
72627844|NCT00565409|144783963|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.83|||<|0.0001|TWO_SIDED|95.0|2.4|6.0||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 64||6.0|2.4|<0.0001
72627845|NCT00565409|144783963|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.22||||0.4919|TWO_SIDED|95.0|0.8|1.9||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 64||1.9|0.8|0.4919
72627846|NCT00565409|144783963|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.16|||<|0.0001|TWO_SIDED|95.0|2.0|4.9||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 64||4.9|2.0|<0.0001
72627847|NCT00565409|144783963|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.8|||<|0.0001|TWO_SIDED|95.0|3.0|7.6||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 72||7.6|3.0|<0.0001
72576034|NCT00168818|144678523|SUPERIORITY_OR_OTHER|||||||0.5062||95.0|||||Fisher Exact|||Comparison versus Enoxaparin||||0.5062
72576035|NCT00168818|144678523|SUPERIORITY_OR_OTHER|||||||0.3717||95.0|||||Fisher Exact|||Comparison versus Enoxaparin||||0.3717
72576036|NCT00168818|144678524|SUPERIORITY_OR_OTHER|||||||0.124||95.0|||||Fisher Exact|||Comparison versus Enoxaparin||||0.1240
72576037|NCT00168818|144678524|SUPERIORITY_OR_OTHER|||||||0.2497||95.0|||||Fisher Exact|||Comparison versus Enoxaparin||||0.2497
72627848|NCT00565409|144783963|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.47||||0.0658|TWO_SIDED|95.0|1.0|2.3||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 72||2.3|1.0|0.0658
72627849|NCT00565409|144783963|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.03|||<|0.0001|TWO_SIDED|95.0|2.0|4.7||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 72||4.7|2.0|<0.0001
72627850|NCT00565409|144783963|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.32|||<|0.0001|TWO_SIDED|95.0|2.7|6.8||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 80||6.8|2.7|<0.0001
72410059|NCT00153101|144328491|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.75||||0.0172||95.0|0.6|0.95|||Regression, Cox|||||0.95|0.60|0.0172
72410060|NCT00153101|144328492|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.9||||0.1431||95.0|0.78|1.04|||Regression, Cox|||||1.04|0.78|0.1431
72576038|NCT00168818|144678526|SUPERIORITY_OR_OTHER|||||||0.4352||95.0|||||Fisher Exact|||Comparison versus Enoxaparin||||0.4352
72627851|NCT00565409|144783963|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.25||||0.4014|TWO_SIDED|95.0|0.8|1.9||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 80||1.9|0.8|0.4014
72627852|NCT00565409|144783963|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.54|||<|0.0001|TWO_SIDED|95.0|2.3|5.5||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 80||5.5|2.3|<0.0001
72410061|NCT00153101|144328493|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.99||||0.8974||95.0|0.81|1.21|||Regression, Cox|||||1.21|0.81|0.8974
72576039|NCT00168818|144678526|SUPERIORITY_OR_OTHER|||||||0.6037||95.0|||||Fisher Exact|||Comparison versus Enoxaparin||||0.6037
72576040|NCT01994291|144678530|NON_INFERIORITY_OR_EQUIVALENCE|Non inferiority was to be declared if the lower limit of the confidence interval for the mean difference at Week 12 is greater than -3.0 letters.|Difference in LS means|-2.32|STANDARD_ERROR_OF_MEAN|1.52||0.1271|TWO_SIDED|80.0|-4.27|-0.37|||Mixed Models Analysis|||The null hypothesis was that the difference, in the mean change from baseline in BCVA in the PF-04634817 group,and the control group is less than or equal to -3 letters.||-0.37|-4.27|0.1271
72576041|NCT01994291|144678530|NON_INFERIORITY_OR_EQUIVALENCE|Non inferiority was to be declared if the lower limit of the confidence interval for the mean difference at Week 12 is greater than -3.0 letters.|Difference in LS means|-2.48|STANDARD_ERROR_OF_MEAN|1.36||0.0699|TWO_SIDED|80.0|-4.24|-0.73|||Mixed Models Analysis|||The null hypothesis was that the difference, in the mean change from baseline in BCVA in the PF-04634817 group,and the control group is less than or equal to -3 letters.||-0.73|-4.24|0.0699
72576042|NCT01994291|144678530|NON_INFERIORITY_OR_EQUIVALENCE|Non inferiority was to be declared if the lower limit of the confidence interval for the mean difference at Week 12 is greater than -3.0 letters.|Difference in LS means|-2.41|STANDARD_ERROR_OF_MEAN|1.17||0.0399|TWO_SIDED|80.0|-3.91|-0.91|||Mixed Models Analysis|||The null hypothesis was that the difference, in the mean change from baseline in BCVA in the PF-04634817 group,and the control group is less than or equal to -3 letters.||-0.91|-3.91|0.0399
72576043|NCT01994291|144678531|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.1416||||0.0218|TWO_SIDED|80.0|-0.2483|-0.0467|||Barnard test|||||-0.0467|-0.2483|0.0218
72627853|NCT00565409|144783963|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.53|||<|0.0001|TWO_SIDED|95.0|2.9|7.2||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 88||7.2|2.9|<0.0001
72627854|NCT00565409|144783963|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.23||||0.2824|TWO_SIDED|95.0|0.8|1.9||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 88||1.9|0.8|0.2824
72627855|NCT00565409|144783963|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.83|||<|0.0001|TWO_SIDED|95.0|2.5|5.9||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 88||5.9|2.5|<0.0001
72627856|NCT00565409|144783964|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 4||||<0.0001
72410062|NCT02610140|144328494|SUPERIORITY||Hazard Ratio (HR)|1.215||||0.859125|TWO_SIDED|95.0|0.85|||1-sided p-value from log-rank test (stratified by TTP on 1st line treatment). P-value is calculated based on alpha level 0.0125.|Log Rank||Hazard ratio (anetumab ravtansine / vinorelbine) was estimated using Cox proportional hazards models with Wald CIs, stratified by Time to progression (TTP) on 1st line treatment.|PFS anetumab ravtansine / vinorelbine||1,738|0.850|0.859125
72410063|NCT02610140|144328495|SUPERIORITY||Hazard Ratio (HR)|1.072||||0.655624|TWO_SIDED|95.0|0.763|1.506||1-sided p-value from log-rank test (stratified by TTP on 1st line treatment). Alpha spending/boundary for interim was 0.00245. Alpha boundary value for final analysis was 0.02421.|Log Rank||Hazard ratio (anetumab ravtansine/vinorelbine) was estimated using Cox proportional hazards models with Wald CIs, stratified by TTP on 1st line treatment.|OS anetumab ravtansine / vinorelbine||1.506|0.763|0.655624
72541706|NCT00986154|144613296|NON_INFERIORITY_OR_EQUIVALENCE|The study was designed to accumulate approximately 220 Overall primary efficacy events in the mITT (modified Intent to Treat) Analysis Set. Assuming equal efficacy (Hazard Ratio = 1.00), a total of 220 events gave a power of 85% to demonstrate that (LMW) heparin/edoxaban was non-inferior to the comparator, considering a relative non-inferiority margin of 1.5 (two sided α=0.05).|Hazard Ratio (HR)|0.89|||<|0.0001|TWO_SIDED|95.0|0.703|1.128|||Regression, Cox||Time to 1st event analyzed by Cox proportional hazards with terms treatment group, randomization stratification factors: Presenting Diagnosis (PE with/without DVT, DVT only); Baseline risk factors (temp factors; all others); Need for reduced dose|(LMW) heparin/edoxaban will be non-inferior to (LMW) heparin/warfarin in preventing recurrence of acute, symptomatic VTE following initial index event. (LMW) Heparin/edoxaban was considered non-inferior to the standard therapy (\[LMW\] heparin/warfarin) if the upper limit of the two-sided 95% confidence interval (CI) for the Hazard Ratio (\[LMW\] heparin/edoxaban to standard therapy) was less than 1.5. Events included in Overall study period if occurred on or after randomization date up to Day 365.||1.128|.703|<0.0001
72576044|NCT01994291|144678531|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.0442||||0.4209|TWO_SIDED|80.0|-0.1217|0.0261|||Barnard test.|||baseline in BCVA in the PF-04634817 group,and the control group is less than or equal to -3 letters.||0.0261|-0.1217|0.4209
72576045|NCT01994291|144678531|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.0849||||0.0778|TWO_SIDED|80.0|-0.1516|-0.0168|||Barnard test.|||||-0.0168|-0.1516|0.0778
72576046|NCT01994291|144678532|SUPERIORITY_OR_OTHER||Difference in LS means|114.07|STANDARD_ERROR_OF_MEAN|19.84|<|0.0001|TWO_SIDED|80.0|88.56|139.59|||Mixed Models Analysis|||||139.59|88.56|<0.0001
72576047|NCT01994291|144678532|SUPERIORITY_OR_OTHER||Difference in LS means|65.81|STANDARD_ERROR_OF_MEAN|18.36||0.0004|TWO_SIDED|80.0|42.2|89.43|||Mixed Models Analysis|||||89.43|42.20|0.0004
72576048|NCT01994291|144678532|SUPERIORITY_OR_OTHER||Difference in LS means|87.32|STANDARD_ERROR_OF_MEAN|15.44|<|0.0001|TWO_SIDED|80.0|67.45|107.19|||Mixed Models Analysis|||||107.19|67.45|<0.0001
72576049|NCT01994291|144678533|SUPERIORITY_OR_OTHER||Difference in LS means|7.98|STANDARD_ERROR_OF_MEAN|1.44|<|0.0001|TWO_SIDED|80.0|6.13|9.83|||ANCOVA|||||9.83|6.13|<0.0001
72627857|NCT00565409|144783964|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 8||||<0.0001
72627858|NCT00565409|144783964|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 12||||<0.0001
72627859|NCT00565409|144783964|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 20||||<0.0001
72627860|NCT00565409|144783964|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 28||||<0.0001
72576050|NCT01994291|144678533|SUPERIORITY_OR_OTHER||Difference in LS means|6.34|STANDARD_ERROR_OF_MEAN|1.28|<|0.0001|TWO_SIDED|80.0|4.7|7.98|||ANCOVA|||||7.98|4.70|<0.0001
72576051|NCT01994291|144678533|SUPERIORITY_OR_OTHER||Difference in LS means|7.07|STANDARD_ERROR_OF_MEAN|1.09|<|0.0001|TWO_SIDED|80.0|5.66|8.48|||ANCOVA|||||8.48|5.66|<0.0001
72576052|NCT01994291|144678534|SUPERIORITY_OR_OTHER||Difference in LS means|0.34|STANDARD_ERROR_OF_MEAN|0.17||0.0423|TWO_SIDED|80.0|0.13|0.55|||ANCOVA|||||0.55|0.13|0.0423
72576053|NCT01994291|144678534|SUPERIORITY_OR_OTHER||Difference in LS means|0.55|STANDARD_ERROR_OF_MEAN|0.15||0.0004|TWO_SIDED|80.0|0.36|0.75|||ANCOVA|||||0.75|0.36|0.0004
72576054|NCT01994291|144678534|SUPERIORITY_OR_OTHER||Difference in LS means|0.46|STANDARD_ERROR_OF_MEAN|0.13||0.0004|TWO_SIDED|80.0|0.3|0.63|||ANCOVA|||||0.63|0.30|0.0004
72576055|NCT03201445|144678561|OTHER||Difference in Percentage|-7.8|||||TWO_SIDED|95.0|-16.3|0.7|||||Difference in percentage and 95% confidence interval (CI) was based on a stratified Mantel-Haenszel test.|||0.7|-16.3|
72576056|NCT03201445|144678563|OTHER||Median Difference (Final Values)|-0.2|||||TWO_SIDED|95.0|-2.1|1.8|||||Difference in Medians and 95% CI for change from baseline at Week 13 was based on quantile regression.|||1.8|-2.1|
72576057|NCT03201445|144678565|OTHER||Median Difference (Final Values)|5.7|||||TWO_SIDED|95.0|-13.4|24.7|||||Difference in medians and 95% CI for change from baseline at Week 13 was based on quantile regression.|||24.7|-13.4|
72576058|NCT03201445|144678567|OTHER||Median Difference (Final Values)|1.0|||||TWO_SIDED|95.0|-2.8|4.9|||||Difference in Medians and 95% CI for change from baseline at Week 13 was based on quantile regression.|||4.9|-2.8|
72627861|NCT00565409|144783964|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||week 36||||<0.0001
72627862|NCT00565409|144783965|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.49||||0.0575|TWO_SIDED|95.0|1.0|2.3||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 36||2.3|1.0|0.0575
72627863|NCT00565409|144783965|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.48||||0.063|TWO_SIDED|95.0|1.0|2.3||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 36||2.3|1.0|0.0630
72627864|NCT00565409|144783965|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.02||||0.916|TWO_SIDED|95.0|0.7|1.6||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 36||1.6|0.7|0.9160
72627865|NCT00565409|144783965|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.76||||0.0147|TWO_SIDED|95.0|1.0|3.0||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 40||3.0|1.0|0.0147
72627866|NCT00565409|144783965|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.02||||0.8675|TWO_SIDED|95.0|0.6|1.6||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 40||1.6|0.6|0.8675
72576059|NCT03201445|144678569|OTHER||Median Difference (Final Values)|0.1|||||TWO_SIDED|95.0|-0.1|0.3|||||Difference in Medians and 95% CI for change from baseline at Week 13 was based on quantile regression.|||0.3|-0.1|
72576060|NCT03201445|144678571|OTHER||Median Difference (Final Values)|2.0|||||TWO_SIDED|95.0|0.0|4.0|||||Difference in Medians and 95% CI for change from baseline at Week 13 was based on quantile regression.|||4|0|
72576061|NCT01695863|144678587|SUPERIORITY||Mean Difference (Final Values)|0.54|||<|0.0001|TWO_SIDED|95.0|0.269|0.816|||t-test, 2 sided|||Right Colon||0.816|0.269|<0.0001
72576062|NCT01695863|144678587|SUPERIORITY||Mean Difference (Final Values)|0.39||||0.005|TWO_SIDED|95.0|0.122|0.655|||t-test, 2 sided|||Transverse Colon||0.655|0.122|0.005
72576063|NCT01695863|144678587|SUPERIORITY||Mean Difference (Final Values)|0.22||||0.08|TWO_SIDED|95.0|-0.029|0.484|||t-test, 2 sided|||Left Colon||0.484|-0.029|0.08
72576064|NCT01695863|144678588|SUPERIORITY||Mean Difference (Final Values)|-0.16||||0.093|TWO_SIDED||||||t-test, 2 sided|||Calcium||||0.093
72576065|NCT01695863|144678588|SUPERIORITY||Mean Difference (Final Values)|2.03||||0.801|TWO_SIDED||||||t-test, 2 sided|||Glucose||||0.801
72576066|NCT01695863|144678588|SUPERIORITY||Mean Difference (Final Values)|-0.44||||0.599|TWO_SIDED||||||t-test, 2 sided|||Blood Urea Nitrogen||||0.599
72576067|NCT01695863|144678588|SUPERIORITY||Mean Difference (Final Values)|-0.01||||0.696|TWO_SIDED||||||t-test, 2 sided|||Creatinine||||0.696
72576068|NCT01695863|144678588|SUPERIORITY||Mean Difference (Final Values)|-1.19||||0.042|TWO_SIDED||||||t-test, 2 sided|||Sodium||||.042
72576069|NCT01695863|144678588|SUPERIORITY||Mean Difference (Final Values)|0.07||||0.596|TWO_SIDED||||||t-test, 2 sided|||Potassium||||0.596
72576070|NCT01695863|144678588|SUPERIORITY||Mean Difference (Final Values)|-0.98||||0.107|TWO_SIDED||||||t-test, 2 sided|||Chloride||||0.107
72576071|NCT01695863|144678588|SUPERIORITY||Mean Difference (Final Values)|0.71||||0.351|TWO_SIDED||||||t-test, 2 sided|||Bicarbonate||||0.351
72576072|NCT01695863|144678589|SUPERIORITY||Mean Difference (Final Values)|-0.0438||||0.772|TWO_SIDED||||||t-test, 2 sided|||Nausea||||0.772
72576073|NCT01695863|144678589|SUPERIORITY||Mean Difference (Final Values)|-0.2821||||0.028|TWO_SIDED||||||t-test, 2 sided|||Vomiting||||0.028
72576074|NCT01695863|144678589|SUPERIORITY||Mean Difference (Final Values)|-0.2102||||0.235|TWO_SIDED||||||t-test, 2 sided|||Bloating||||0.235
72576075|NCT01695863|144678589|SUPERIORITY||Mean Difference (Final Values)|-0.0547||||0.707|TWO_SIDED||||||t-test, 2 sided|||Abdominal pain or cramping||||0.707
72576076|NCT01695863|144678589|SUPERIORITY||Mean Difference (Final Values)|-0.0269||||0.773|TWO_SIDED||||||t-test, 2 sided|||Ability to complete entire prep||||0.773
72576077|NCT01695863|144678589|SUPERIORITY||Mean Difference (Final Values)|0.0498||||0.766|TWO_SIDED||||||t-test, 2 sided|||Difficulty/Inconvenience in completing prep||||0.766
72576078|NCT00642278|144678596|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-0.45|STANDARD_ERROR_OF_MEAN|0.116|<|0.001|TWO_SIDED|95.0|-0.747|-0.148||Adjusted using Dunnett's procedure.|ANCOVA|ANCOVA model included terms for treatment, baseline value, and stratification factor (participation in mixed meal tolerance test).||||-0.148|-0.747|<0.001
72576079|NCT00642278|144678596|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-0.51|STANDARD_ERROR_OF_MEAN|0.116|<|0.001|TWO_SIDED|95.0|-0.804|-0.207||Adjusted using Dunnett's procedure.|ANCOVA|ANCOVA model included terms for treatment, baseline value, and stratification factor (participation in mixed meal tolerance test).||||-0.207|-0.804|<0.001
72576080|NCT00642278|144678596|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-0.54|STANDARD_ERROR_OF_MEAN|0.116|<|0.001|TWO_SIDED|95.0|-0.841|-0.244||Adjusted using Dunnett's procedure.|ANCOVA|ANCOVA model included terms for treatment, baseline value, and stratification factor (participation in mixed meal tolerance test).||||-0.244|-0.841|<0.001
72576081|NCT00642278|144678596|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-0.71|STANDARD_ERROR_OF_MEAN|0.117|<|0.001|TWO_SIDED|95.0|-1.006|-0.405||Adjusted using Dunnett's procedure.|ANCOVA|ANCOVA model included terms for treatment, baseline value, and stratification factor (participation in mixed meal tolerance test).||||-0.405|-1.006|<0.001
72576082|NCT00642278|144678596|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-0.73|STANDARD_ERROR_OF_MEAN|0.116|<|0.001|TWO_SIDED|95.0|-1.029|-0.432||Adjusted using Dunnett's procedure.|ANCOVA|ANCOVA model included terms for treatment, baseline value, and stratification factor (participation in mixed meal tolerance test).||||-0.432|-1.029|<0.001
72576083|NCT00642278|144678596|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-0.56|STANDARD_ERROR_OF_MEAN|0.116|<|0.001|TWO_SIDED|95.0|-0.862|-0.265||Adjusted using Dunnett's procedure.|ANCOVA|ANCOVA model included terms for treatment, baseline value, and stratification factor (participation in mixed meal tolerance test).||||-0.265|-0.862|<0.001
72576084|NCT00642278|144678597|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|0.27||0.001|TWO_SIDED|95.0|-1.39|-0.34|||ANCOVA|ANCOVA model included terms for treatment, baseline value, and stratification factor (participation in mixed meal tolerance test).||||-0.34|-1.39|0.001
72576085|NCT00642278|144678597|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-1.4|STANDARD_ERROR_OF_MEAN|0.27|<|0.001|TWO_SIDED|95.0|-1.98|-0.92|||ANCOVA|ANCOVA model included terms for treatment, baseline value, and stratification factor (participation in mixed meal tolerance test).||||-0.92|-1.98|<0.001
72576086|NCT00642278|144678597|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-1.8|STANDARD_ERROR_OF_MEAN|0.27|<|0.001|TWO_SIDED|95.0|-2.33|-1.27|||ANCOVA|ANCOVA model included terms for treatment, baseline value, and stratification factor (participation in mixed meal tolerance test).||||-1.27|-2.33|<0.001
72576087|NCT00642278|144678597|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-1.8|STANDARD_ERROR_OF_MEAN|0.27|<|0.001|TWO_SIDED|95.0|-2.32|-1.26|||ANCOVA|ANCOVA model included terms for treatment, baseline value, and stratification factor (participation in mixed meal tolerance test).||||-1.26|-2.32|<0.001
72576088|NCT00642278|144678597|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-1.7|STANDARD_ERROR_OF_MEAN|0.27|<|0.001|TWO_SIDED|95.0|-2.25|-1.19|||ANCOVA|ANCOVA model included terms for treatment, baseline value, and stratification factor (participation in mixed meal tolerance test).||||-1.19|-2.25|<0.001
72576089|NCT00642278|144678597|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.27|<|0.001|TWO_SIDED|95.0|-1.51|-0.46|||ANCOVA|ANCOVA model included terms for treatment, baseline value, and stratification factor (participation in mixed meal tolerance test).||||-0.46|-1.51|<0.001
72576090|NCT00642278|144678599|SUPERIORITY_OR_OTHER||Least-Sqaures Mean Difference|36.1|STANDARD_ERROR_OF_MEAN|5.1|<|0.001|TWO_SIDED|95.0|26.07|46.13|||ANCOVA|ANCOVA model included terms for treatment, baseline value, and stratification factor (participation in mixed meal tolerance test).||||46.13|26.07|<0.001
72576091|NCT00642278|144678599|SUPERIORITY_OR_OTHER||Least-Sqaures Mean Difference|49.3|STANDARD_ERROR_OF_MEAN|5.13|<|0.001|TWO_SIDED|95.0|39.17|59.34|||ANCOVA|ANCOVA model included terms for treatment, baseline value, and stratification factor (participation in mixed meal tolerance test).||||59.34|39.17|<0.001
72576092|NCT00642278|144678599|SUPERIORITY_OR_OTHER||Least-Sqaures Mean Difference|48.2|STANDARD_ERROR_OF_MEAN|5.2|<|0.001|TWO_SIDED|95.0|37.98|58.42|||ANCOVA|ANCOVA model included terms for treatment, baseline value, and stratification factor (participation in mixed meal tolerance test).||||58.42|37.98|<0.001
72576093|NCT00642278|144678599|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|49.0|STANDARD_ERROR_OF_MEAN|5.11|<|0.001|TWO_SIDED|95.0|38.91|59.01|||ANCOVA|ANCOVA model included terms for treatment, baseline value, and stratification factor (participation in mixed meal tolerance test).||||59.01|38.91|<0.001
72576094|NCT00642278|144678599|SUPERIORITY_OR_OTHER||Least-Sqaures Mean Difference|60.3|STANDARD_ERROR_OF_MEAN|5.13|<|0.001|TWO_SIDED|95.0|50.17|70.35|||ANCOVA|ANCOVA model included terms for treatment, baseline value, and stratification factor (participation in mixed meal tolerance test).||||70.35|50.17|<0.001
72576095|NCT00642278|144678599|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-3.3|STANDARD_ERROR_OF_MEAN|5.09||0.513|TWO_SIDED|95.0|-13.33|6.67|||ANCOVA|ANCOVA model included terms for treatment, baseline value, and stratification factor (participation in mixed meal tolerance test).||||6.67|-13.33|0.513
72576096|NCT00642278|144678601|SUPERIORITY_OR_OTHER||Least-Sqaures Mean Difference|-1.3|STANDARD_ERROR_OF_MEAN|0.5||0.009|TWO_SIDED|95.0|-2.2|-0.3|||ANCOVA|ANCOVA model included terms for treatment, baseline value, and stratification factor (participation in mixed meal tolerance test).||||-0.3|-2.2|0.009
72576097|NCT00642278|144678601|SUPERIORITY_OR_OTHER||Least-Sqaures Mean Difference|-1.5|STANDARD_ERROR_OF_MEAN|0.5||0.002|TWO_SIDED|95.0|-2.5|-0.6|||ANCOVA|ANCOVA model included terms for treatment, baseline value, and stratification factor (participation in mixed meal tolerance test).||||-0.6|-2.5|0.002
72576098|NCT00642278|144678601|SUPERIORITY_OR_OTHER||Least-Sqaures Mean Difference|-1.6|STANDARD_ERROR_OF_MEAN|0.5|<|0.001|TWO_SIDED|95.0|-2.6|-0.7|||ANCOVA|ANCOVA model included terms for treatment, baseline value, and mixed meal tolerance test.||||-0.7|-2.6|<0.001
72576099|NCT00642278|144678601|SUPERIORITY_OR_OTHER||Least-Sqaures Mean Difference|-2.3|STANDARD_ERROR_OF_MEAN|0.5|<|0.001|TWO_SIDED|95.0|-3.3|-1.4|||ANCOVA|ANCOVA model included terms for treatment, baseline value, and stratification factor (participation in mixed meal tolerance test).||||-1.4|-3.3|<0.001
72576100|NCT00642278|144678601|SUPERIORITY_OR_OTHER||Least-Sqaures Mean Difference|-2.3|STANDARD_ERROR_OF_MEAN|0.5|<|0.001|TWO_SIDED|95.0|-3.3|-1.4|||ANCOVA|ANCOVA model included terms for treatment, baseline value, and stratification factor (participation in mixed meal tolerance test).||||-1.4|-3.3|<0.001
72576101|NCT00642278|144678601|SUPERIORITY_OR_OTHER||Least-Sqaures Mean Difference|0.4|STANDARD_ERROR_OF_MEAN|0.5||0.371|TWO_SIDED|95.0|-0.5|1.4|||ANCOVA|ANCOVA model included terms for treatment, baseline value, and stratification factor (participation in mixed meal tolerance test).||||1.4|-0.5|0.371
72576102|NCT03713619|144678607|SUPERIORITY||Odds Ratio, log|1.75||||0.007|TWO_SIDED|95.0|1.12|2.73|||Regression, Logistic|||Logistic regression analysis of HiSCR50 response at Week 16 (multiple imputation)||2.73|1.12|0.0070
72576103|NCT03713619|144678607|SUPERIORITY||Odds Ratio (OR)|1.48||||0.0418|TWO_SIDED|95.0|0.95|2.32|||Regression, Logistic|||Logistic regression analysis of HiSCR50 response at Week 16 (multiple imputation)||2.32|0.95|0.0418
72576104|NCT03713619|144678608|SUPERIORITY||Least square Mean Difference|-23.05|||<|0.0001|TWO_SIDED|95.0|-33.9|-12.21|||ANCOVA|||Analysis of covariance of percentage change from baseline in AN count at Week 16 (multiple imputation)||-12.21|-33.90|<0.0001
72576105|NCT03713619|144678608|SUPERIORITY||Least Square Mean difference|-18.46||||0.0004|TWO_SIDED|95.0|-29.32|-7.6|||ANCOVA|||Analysis of covariance of percentage change from baseline in AN count at Week 16 (multiple imputation)||-7.60|-29.32|0.0004
72576106|NCT03713619|144678609|SUPERIORITY||Odds Ratio, log|0.42||||0.001|TWO_SIDED|95.0|0.25|0.73|||Regression, Logistic|||Logistic regression analysis of Flare over 16 weeks (multiple imputation)||0.73|0.25|0.0010
72576107|NCT03713619|144678609|SUPERIORITY||Odds Ratio (OR)|0.71||||0.0926|TWO_SIDED|95.0|0.43|1.17|||Regression, Logistic|||Logistic regression analysis of Flare over 16 weeks (multiple imputation)||1.17|0.43|0.0926
72576108|NCT03713619|144678610|SUPERIORITY||Odds Ratio (OR)|1.84||||0.0248|TWO_SIDED|95.0|1.0|3.4|||Regression, Logistic|||Logistic regression analysis of skin pain/NRS30 response at Week 16 (pooled data, multiple imputation)||3.40|1.00|0.0248
72576109|NCT03713619|144678610|SUPERIORITY||Odds Ratio, log|1.77||||0.0044|TWO_SIDED|95.0|1.15|2.0|||Regression, Logistic|||Logistic regression analysis of skin pain/NRS30 response at Week 16 (pooled data, multiple imputation)||2.0|1.15|0.0044
72576110|NCT03095638|144678611|OTHER||Ratio|1.0084|||||TWO_SIDED|90.0|0.8626|1.1789||||||||1.1789|0.8626|
72576111|NCT03095638|144678612|OTHER||Ratio|1.0121|||||TWO_SIDED|90.0|0.8648|1.1845||||||||1.1845|0.8648|
72576112|NCT03095638|144678613|OTHER||Ration|1.0329|||||TWO_SIDED|90.0|0.8623|1.2373||||||||1.2373|0.8623|
72576113|NCT03095638|144678614|OTHER||Ratio|1.6242|||||TWO_SIDED|90.0|1.4986|1.7604||||||||1.7604|1.4986|
72576114|NCT03095638|144678614|OTHER||Ratio|1.5448|||||TWO_SIDED|90.0|1.4253|1.6743||||||||1.6743|1.4253|
72576115|NCT03095638|144678615|OTHER||Ratio|1.6292|||||TWO_SIDED|90.0|1.503|1.7661||||||||1.7661|1.5030|
72576116|NCT03095638|144678615|OTHER||Ratio|1.5519|||||TWO_SIDED|90.0|1.4317|1.6822||||||||1.6822|1.4317|
72576117|NCT03095638|144678616|OTHER||Ratio|1.7933|||||TWO_SIDED|90.0|1.6226|1.9819||||||||1.9819|1.6226|
72576118|NCT03095638|144678616|OTHER||Ratio|1.7974|||||TWO_SIDED|90.0|1.6263|1.9865||||||||1.9865|1.6263|
72576119|NCT06281171|144678671|SUPERIORITY||||||<|0.001|||||||Regression, Linear|||||||<.001
72576120|NCT06281171|144678672|SUPERIORITY|||||||0.996|||||||t-test, 2 sided|||||||.996
72576121|NCT06281171|144678673|SUPERIORITY|||||||0.782|||||||t-test, 2 sided|||||||.782
72576122|NCT06281171|144678674|SUPERIORITY|||||||0.54|||||||Regression, Linear|||||||0.54
72576123|NCT06281171|144678675|SUPERIORITY|||||||0.03|||||||Regression, Linear|||||||0.03
72576124|NCT06281171|144678676|SUPERIORITY|||||||0.3|||||||Regression, Linear|||||||0.30
72576125|NCT06281171|144678677|SUPERIORITY|||||||0.06|||||||Regression, Linear|||||||0.06
72576126|NCT02552212|144678678|OTHER||Odds Ratio (OR)|15.231|||<|0.001|TWO_SIDED|95.0|7.336|31.623|||Regression, Logistic|||Odds ratio: CZP/Placebo and p-value were calculated using logistic regression with factors for treatment, region and Magnetic Resonance Imaging/C- Reactive Protein (MRI/CRP) classification.||31.623|7.336|<0.001
72576127|NCT02552212|144678679|OTHER||Odds Ratio (OR)|7.436|||<|0.001|TWO_SIDED|95.0|4.127|13.401|||Regression, Logistic|||Odds ratio: CZP/Placebo and p-value were calculated using logistic regression with factors for treatment, region and MRI/CRP classification.||13.401|4.127|<0.001
72576128|NCT02552212|144678689|OTHER||Odds Ratio (OR)|7.359|||<|0.001|TWO_SIDED|95.0|4.286|12.636|||Regression, Logistic|||Odds ratio: CZP/Placebo and p-value were calculated using logistic regression with factors for treatment, region MRI/CRP classification.||12.636|4.286|<0.001
72576129|NCT02552212|144678690|OTHER||Difference|-1.696|||<|0.001|TWO_SIDED|95.0|-2.11|-1.282|||ANCOVA|||From an ANCOVA model including scores at Baseline, treatment group, region and MRI/CRP classification.||-1.282|-2.110|<0.001
72576130|NCT02552212|144678691|OTHER||Difference|-1.585|||<|0.0001|TWO_SIDED|95.0|-2.132|-1.038|||ANCOVA|||From an ANCOVA model including scores at Baseline, treatment group, region and MRI/CRP classification.||-1.038|-2.132|<0.0001
72576131|NCT02552212|144678692|OTHER||Difference|-1.819|||<|0.001|TWO_SIDED|95.0|-2.25|-1.388|||ANCOVA|||From an ANCOVA model including scores at Baseline, treatment group, region and MRI/CRP classification.||-1.388|-2.250|<0.001
72576132|NCT02552212|144678693|OTHER||Difference|-1.29|||<|0.001|TWO_SIDED|95.0|-1.909|-0.672|||ANCOVA|||From an ANCOVA model including scores at Baseline, treatment group, region and MRI/CRP classification.||-0.672|-1.909|<0.001
72576133|NCT02552212|144678694|OTHER||Difference|-4.8687|||<|0.001|TWO_SIDED|95.0|-6.4014|-3.336|||ANCOVA|||From an ANCOVA model including scores at Baseline, treatment group, region and MRI/CRP classification.||-3.3360|-6.4014|<0.001
72576134|NCT02552212|144678695|OTHER||Odds Ratio (OR)|6.223|||<|0.001|TWO_SIDED|95.0|3.8|10.191|||Regression, Logistic|||Odds ratio: CZP/Placebo and p-value were calculated using logistic regression with factors for treatment, region and MRI/CRP classification.||10.191|3.800|<0.001
72576135|NCT02552212|144678696|OTHER||Difference|-0.183|||<|0.001|TWO_SIDED|95.0|-0.25|-0.117|||ANCOVA|||From an ANCOVA model including scores at Baseline, treatment group, region and MRI/CRP classification.||-0.117|-0.250|<0.001
72576136|NCT02552212|144678704|OTHER||Difference|-1.9|||<|0.001|TWO_SIDED|95.0|-2.62|-1.18|||ANCOVA|||From an ANCOVA model including scores at Baseline, treatment group, region and MRI/CRP classification.||-1.18|-2.62|<0.001
72576137|NCT02552212|144678705|OTHER||Odds Ratio (OR)|0.484|||=|0.247|TWO_SIDED|95.0|0.142|1.653|||Regression, Logistic|||Odds ratio: CZP/PBO and p-value were calculated using logistic regression with factors for treatment, region and MRI/CRP classification.||1.653|0.142|=0.247
72576138|NCT03020589|144678710|SUPERIORITY||Risk Ratio (RR)|1.27||||0.58|TWO_SIDED|95.0|0.67|2.05|||Fisher Exact|||||2.05|0.67|0.58
72576139|NCT03020589|144678711|SUPERIORITY||Risk Ratio (RR)|1.26||||0.46|TWO_SIDED|95.0|0.72|2.02|||Fisher Exact|||||2.02|0.72|0.46
72576140|NCT00205803|144678723|SUPERIORITY_OR_OTHER||Difference|-2.26|||||TWO_SIDED|95.0|-8.08|2.33||||||For serotype 4 the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||2.33|-8.08|
72576141|NCT00205803|144678723|SUPERIORITY_OR_OTHER||Difference|-0.49|||||TWO_SIDED|95.0|-9.93|8.65||||||For serotype 6B the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||8.65|-9.93|
72576142|NCT00205803|144678723|SUPERIORITY_OR_OTHER||Difference|-2.27|||||TWO_SIDED|95.0|-8.07|2.26||||||For serotype 9V the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||2.26|-8.07|
72576143|NCT00205803|144678723|SUPERIORITY_OR_OTHER||Difference|0.68||||||95.0|-4.96|6.16||||||For serotype 14 the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||6.16|-4.96|
72576144|NCT00205803|144678723|SUPERIORITY_OR_OTHER||Difference|-2.25||||||95.0|-8.18|2.36||||||For serotype 18C the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||2.36|-8.18|
72576145|NCT00205803|144678723|SUPERIORITY_OR_OTHER||Difference|0.7||||||95.0|-4.84|6.32||||||For serotype 19F the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||6.32|-4.84|
72576146|NCT00205803|144678723|SUPERIORITY_OR_OTHER||Difference|-0.69||||||95.0|-7.75|5.86||||||For serotype 23F the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||5.86|-7.75|
72576147|NCT00205803|144678723|SUPERIORITY_OR_OTHER||Difference|72.87||||||95.0|63.32|81.07||||||For serotype 1 the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||81.07|63.32|
72576148|NCT00205803|144678723|SUPERIORITY_OR_OTHER||Difference|84.92||||||95.0|76.73|91.05||||||For serotype 3 the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||91.05|76.73|
72576149|NCT00205803|144678723|SUPERIORITY_OR_OTHER||Difference|57.94||||||95.0|48.01|67.42||||||For serotype 5 the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||67.42|48.01|
72576150|NCT00205803|144678723|SUPERIORITY_OR_OTHER||Difference|62.81||||||95.0|52.33|72.2||||||For serotype 6A the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||72.20|52.33|
72576151|NCT00205803|144678723|SUPERIORITY_OR_OTHER||Difference|92.27||||||95.0|85.26|96.54||||||For serotype 7F the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||96.54|85.26|
72410064|NCT02610140|144328500|SUPERIORITY||Difference (%) improvement rate symptoms|4.65||||0.244|TWO_SIDED|95.0|-8.2|17.51|||Cochran-Mantel-Haenszel|1-sided Cochran-Mantel-Haenszel test, stratified by TTP on 1st line treatment||Anetumab ravtansine versus vinorelbine||17.51|-8.20|0.244
72576152|NCT00205803|144678723|SUPERIORITY_OR_OTHER||Difference|5.61||||||95.0|1.23|11.86||||||For serotype 19A the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||11.86|1.23|
72576153|NCT00205803|144678724|SUPERIORITY_OR_OTHER||Difference|-1.5||||||95.0|-7.9|3.6||||||For serotype 4 the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||3.6|-7.9|
72576154|NCT00205803|144678724|SUPERIORITY_OR_OTHER||Difference|0.0||||||95.0|-4.6|4.0||||||For serotype 6B the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||4.0|-4.6|
72576155|NCT00205803|144678724|SUPERIORITY_OR_OTHER||Difference|-1.3||||||95.0|-6.9|2.8||||||For serotype 9V the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||2.8|-6.9|
72576156|NCT00205803|144678724|SUPERIORITY_OR_OTHER||Difference|0.0||||||95.0|-4.6|4.0||||||For serotype 14 the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||4.0|-4.6|
72576157|NCT00205803|144678724|SUPERIORITY_OR_OTHER||Difference|0.0||||||95.0|-4.7|3.9||||||For serotype 18C the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||3.9|-4.7|
72576158|NCT00205803|144678724|SUPERIORITY_OR_OTHER||Difference|0.0||||||95.0|-4.6|4.0||||||For serotype 19F the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||4.0|-4.6|
72576159|NCT00205803|144678724|SUPERIORITY_OR_OTHER||Difference|2.2||||||95.0|-2.6|7.7||||||For serotype 23F the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||7.7|-2.6|
72576160|NCT00205803|144678724|SUPERIORITY_OR_OTHER||Difference|97.8||||||95.0|92.3|99.7||||||For serotype 1 the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||99.7|92.3|
72576161|NCT00205803|144678724|SUPERIORITY_OR_OTHER||Difference|83.6||||||95.0|73.2|90.8||||||For serotype 3 the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||90.8|73.2|
72576162|NCT00205803|144678724|SUPERIORITY_OR_OTHER||Difference|29.5||||||95.0|19.7|40.9||||||For serotype 5 the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||40.9|19.7|
72576163|NCT00205803|144678724|SUPERIORITY_OR_OTHER||Difference|12.0||||||95.0|5.9|20.4||||||For serotype 6A the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||20.4|5.9|
72576164|NCT00205803|144678724|SUPERIORITY_OR_OTHER||Difference|94.1||||||95.0|86.8|98.1||||||For serotype 7F the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||98.1|86.8|
72576165|NCT00205803|144678724|SUPERIORITY_OR_OTHER||Difference|0.0||||||95.0|-4.6|4.0||||||For serotype 19A the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||4.0|-4.6|
72576166|NCT00205803|144678725|SUPERIORITY_OR_OTHER||Ratio|0.76||||||95.0|0.59|0.96||||||For serotype 4 the GMC ratio (13vPnC/7vPnC) was calculated||0.96|0.59|
72576167|NCT00205803|144678725|SUPERIORITY_OR_OTHER||Ratio|0.96||||||95.0|0.62|1.48||||||For serotype 6B the GMC ratio (13vPnC/7vPnC) was calculated||1.48|0.62|
72576168|NCT00205803|144678725|SUPERIORITY_OR_OTHER||Difference|0.85||||||95.0|0.69|1.05||||||For serotype 9V the GMC ratio (13vPnC/7vPnC) was calculated||1.05|0.69|
72576169|NCT00205803|144678725|SUPERIORITY_OR_OTHER||Ratio|0.82||||||95.0|0.6|1.11||||||For serotype 14 the GMC ratio (13vPnC/7vPnC) was calculated||1.11|0.60|
72576170|NCT00205803|144678725|SUPERIORITY_OR_OTHER||Ratio|0.62||||||95.0|0.49|0.79||||||For serotype 18C the GMC ratio (13vPnC/7vPnC) was calculated||0.79|0.49|
72576171|NCT00205803|144678725|SUPERIORITY_OR_OTHER||Ratio|0.86||||||95.0|0.67|1.09||||||For serotype 19F the GMC ratio (13vPnC/7vPnC) was calculated||1.09|0.67|
72576172|NCT00205803|144678725|SUPERIORITY_OR_OTHER||Ratio|0.77||||||95.0|0.59|1.0||||||For serotype 23F the GMC ratio (13vPnC/7vPnC) was calculated||1.00|0.59|
72576173|NCT00205803|144678725|SUPERIORITY_OR_OTHER||Ratio|39.78||||||95.0|27.47|57.63||||||For serotype 1 the GMC ratio (13vPnC/7vPnC) was calculated||57.63|27.47|
72576174|NCT00205803|144678725|SUPERIORITY_OR_OTHER||Ratio|15.56||||||95.0|11.63|20.81||||||For serotype 3 the GMC ratio (13vPnC/7vPnC) was calculated||20.81|11.63|
72576175|NCT00205803|144678725|SUPERIORITY_OR_OTHER||Ratio|8.67||||||95.0|6.65|11.29||||||For serotype 5 the GMC ratio (13vPnC/7vPnC) was calculated||11.29|6.65|
72576176|NCT00205803|144678725|SUPERIORITY_OR_OTHER||Ratio|9.6||||||95.0|7.07|13.04||||||For serotype 6A the GMC ratio (13vPnC/7vPnC) was calculated||13.04|7.07|
72576177|NCT00205803|144678725|SUPERIORITY_OR_OTHER||Ratio|26.78||||||95.0|20.97|34.22||||||For serotype 7F the GMC ratio (13vPnC/7vPnC) was calculated||34.22|20.97|
72576178|NCT00205803|144678725|SUPERIORITY_OR_OTHER||Ratio|1.71||||||95.0|1.36|2.16||||||For serotype 19A the GMC ratio (13vPnC/7vPnC) was calculated||2.16|1.36|
72576179|NCT00205803|144678727|SUPERIORITY_OR_OTHER||Difference|3.08||||||95.0|-7.22|13.73||||||For Haemophilus influenzae type b the difference in percentage between the two groups (13vPnC - 7vPnC) at 0.15 µg/mL threshold was calculated||13.73|-7.22|
72576180|NCT00205803|144678727|SUPERIORITY_OR_OTHER||Difference|7.02||||||95.0|-7.28|21.14||||||For Haemophilus influenzae type b the difference in percentage between the two groups (13vPnC - 7vPnC) at 1.0 µg/mL threshold was calculated||21.14|-7.28|
72576181|NCT00205803|144678727|SUPERIORITY_OR_OTHER||Difference|0.0||||||95.0|-9.38|7.73||||||For Diphtheria the difference in percentage between the two groups (13vPnC - 7vPnC) at 0.01 IU/mL and 0.1 IU/mL thresholds was calculated||7.73|-9.38|
72576182|NCT00205803|144678727|SUPERIORITY_OR_OTHER||Difference|0.0||||||95.0|-9.38|7.73||||||For Tetanus the difference in percentage between the two groups (13vPnC - 7vPnC) at 0.01 IU/mL and 0.1 IU/mL thresholds was calculated||7.73|-9.38|
72576183|NCT00205803|144678727|SUPERIORITY_OR_OTHER||Difference|0.0||||||95.0|-5.97|5.68||||||For Polio Type 1 the difference in percentage between the two groups (13vPnC - 7vPnC) at 1:8 threshold was calculated||5.68|-5.97|
72541707|NCT00986154|144613297|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.0||||0.9933|TWO_SIDED|95.0|0.832|1.2|||Regression, Cox||Time to 1st event analyzed by Cox proportional hazards with terms treatment group, randomization stratification factors: Presenting Diagnosis (PE with/without DVT, DVT only); Baseline risk factors (temp factors; all others); Need for reduced dose.|||1.200|.832|.9933
72627867|NCT00565409|144783965|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.77||||0.0174|TWO_SIDED|95.0|1.1|3.0||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 40||3.0|1.1|0.0174
72627868|NCT00565409|144783965|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.24|||<|0.0001|TWO_SIDED|95.0|1.9|5.7||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 48||5.7|1.9|<0.0001
72627869|NCT00565409|144783965|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.85||||0.4941|TWO_SIDED|95.0|0.5|1.3||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 48||1.3|0.5|0.4941
72541708|NCT00986154|144613298|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.81||||0.004|TWO_SIDED|95.0|0.705|0.936|||Regression, Cox||Time to 1st event analyzed by Cox proportional hazards with terms treatment group, randomization stratification factors: Presenting Diagnosis (PE with/without DVT, DVT only); Baseline risk factors (temp factors; all others); Need for reduced dose|"Safety Analysis set includes all randomized subjects who received at least one dose of study drug.~Null hypothesis (LMW) heparin/edoxaban will be comparable to (LMW) heparin/warfarin in preventing recurrence of major or clinically relevant non-major bleeding."||.936|.705|.0040
72627870|NCT00565409|144783965|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.01|||<|0.0001|TWO_SIDED|95.0|2.3|7.0||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 48||7.0|2.3|<0.0001
72627871|NCT00565409|144783965|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.4|||<|0.0001|TWO_SIDED|95.0|2.0|5.9||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 56||5.9|2.0|<0.0001
72627872|NCT00565409|144783965|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.95||||0.8185|TWO_SIDED|95.0|0.6|1.5||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 56||1.5|0.6|0.8185
72627873|NCT00565409|144783965|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.66|||<|0.0001|TWO_SIDED|95.0|2.1|6.4||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 56||6.4|2.1|<0.0001
72541709|NCT03726437|144613299|SUPERIORITY|Analyses were performed to determine whether RealConsent was superior to Stress and Mood Management in reducing incidence of sexual violence victimization.|Risk Ratio (RR)|0.48||||0.0002|TWO_SIDED|95.0|0.33|0.69|||Mixed Models Analysis|Models adjusted for fixed effects.||||.69|.33|.0002
72627874|NCT00565409|144783965|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.78|||<|0.0001|TWO_SIDED|95.0|2.2|6.6||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 64||6.6|2.2|<0.0001
72627875|NCT00565409|144783965|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.17||||0.4254|TWO_SIDED|95.0|0.7|1.8||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 64||1.8|0.7|0.4254
72627876|NCT00565409|144783965|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.38|||<|0.0001|TWO_SIDED|95.0|1.9|5.9||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 64||5.9|1.9|<0.0001
72627877|NCT00565409|144783965|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.26|||<|0.0001|TWO_SIDED|95.0|1.8|5.8||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 72||5.8|1.8|<0.0001
72541710|NCT03726437|144613299|SUPERIORITY||Odds Ratio (OR)|0.77||||0.31|TWO_SIDED|95.0|0.47|1.28|||Mixed Models Analysis|Models adjusted for fixed effects.||||1.28|.47|.31
72541711|NCT03726437|144613300|SUPERIORITY||Adjusted OR|1.17||||0.03|TWO_SIDED|95.0|0.12|1.22|||Mixed Models Analysis|Model adjusted for fixed effects.||||1.22|0.12|.03
72627878|NCT00565409|144783965|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.06||||0.8766|TWO_SIDED|95.0|0.7|1.6||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 72||1.6|0.7|0.8766
72627879|NCT00565409|144783965|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.67|||<|0.0001|TWO_SIDED|95.0|2.1|6.4||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 72||6.4|2.1|<0.0001
72627880|NCT00565409|144783965|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.53|||<|0.0001|TWO_SIDED|95.0|2.0|6.4||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 80||6.4|2.0|<0.0001
72627881|NCT00565409|144783965|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.21||||0.3535|TWO_SIDED|95.0|0.8|1.9||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 80||1.9|0.8|0.3535
72627882|NCT00565409|144783965|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.44|||<|0.0001|TWO_SIDED|95.0|1.9|6.1||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 80||6.1|1.9|<0.0001
72627883|NCT00565409|144783965|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.45|||<|0.0001|TWO_SIDED|95.0|2.0|6.1||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 88||6.1|2.0|<0.0001
72627884|NCT00565409|144783965|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.25||||0.3231|TWO_SIDED|95.0|0.8|1.9||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 88||1.9|0.8|0.3231
72410065|NCT02610140|144328501|SUPERIORITY||Hazard Ratio (HR)|0.829||||0.313747|TWO_SIDED|95.0|0.386|1.779|||Log Rank|one-sided log-rank test stratified by time to progression (TTP) on first line treatment||Anetumab ravtansine versus vinorelbine||1.779|0.386|0.313747
72410066|NCT02610140|144328502|SUPERIORITY||Hazard Ratio (HR)|0.924||||0.378916|TWO_SIDED|95.0|0.557|1.533|||Log Rank|one-sided log-rank test stratified by time to progression (TTP) on first line treatment||Anetumab ravtansine versus vinorelbine||1.533|0.557|0.378916
72410067|NCT02610140|144328503|SUPERIORITY||Difference (%) improvement rate of pain|6.64||||0.214|TWO_SIDED|95.0|-9.4|22.68|||Cochran-Mantel-Haenszel|1-sided Cochran-Mantel-Haenszel test, stratified by TTP on 1st line treatment||||22.68|-9.40|0.214
72410068|NCT02610140|144328506|SUPERIORITY||Mean Difference (Final Values)|9.5|||||TWO_SIDED|95.0|0.1|39.3||||||||39.3|0.1|
72410069|NCT02610140|144328506|SUPERIORITY||Mean Difference (Final Values)|11.6|||||TWO_SIDED|95.0|0.0|35.9||||||||35.9|0.0|
72576184|NCT00205803|144678727|SUPERIORITY_OR_OTHER||Difference|-1.64||||||95.0|-8.8|4.24||||||For Polio Type 2 the difference in percentage between the two groups (13vPnC - 7vPnC) at 1:8 threshold was calculated||4.24|-8.80|
72576185|NCT00205803|144678727|SUPERIORITY_OR_OTHER||Difference|-1.64||||||95.0|-8.8|4.21||||||For Polio Type 3 the difference in percentage between the two groups (13vPnC - 7vPnC) at 1:8 threshold was calculated||4.21|-8.80|
72576186|NCT00205803|144678727|SUPERIORITY_OR_OTHER||Difference|0.0||||||95.0|-9.38|7.73||||||For Hepatitis b the difference in percentage between the two groups (13vPnC - 7vPnC) at 10 mIU/mL threshold was calculated||7.73|-9.38|
72576187|NCT00205803|144678727|SUPERIORITY_OR_OTHER||Difference|-1.74||||||95.0|-11.0|6.99||||||For Pertussis - FHA the difference in percentage between the two groups (13vPnC - 7vPnC) at 82.00 EU/MI threshold was calculated||6.99|-11.00|
72576188|NCT00205803|144678727|SUPERIORITY_OR_OTHER||Difference|-6.36||||||95.0|-17.03|3.16||||||For Pertussis - PT the difference in percentage between the two groups (13vPnC - 7vPnC) at 43.00 EU/mL threshold was calculated||3.16|-17.03|
72576189|NCT00205803|144678727|SUPERIORITY_OR_OTHER||Difference|1.33||||||95.0|-6.79|9.68||||||For Pertussis - Pertactin the difference in percentage between the two groups (13vPnC - 7vPnC) at 18.00 EU/mL threshold was calculated||9.68|-6.79|
72410070|NCT03169153|144328507|SUPERIORITY||||||<|0.0001|||||||Mixed effects repeated measures|||||||<0.0001
72410071|NCT00887341|144328508|SUPERIORITY_OR_OTHER|||||||0.238|||||||Chi-squared|||||||0.238
72410072|NCT00887341|144328515|SUPERIORITY_OR_OTHER|||||||0.121|||||||Chi-squared|||Week 4||||0.121
72410073|NCT00887341|144328515|SUPERIORITY_OR_OTHER|||||||0.809|||||||Chi-squared|||Week 8||||0.809
72410074|NCT00887341|144328515|SUPERIORITY_OR_OTHER|||||||0.367|||||||Chi-squared|||Week 12||||0.367
72410075|NCT00887341|144328515|SUPERIORITY_OR_OTHER|||||||0.339|||||||Chi-squared|||Week 16||||0.339
72410076|NCT00887341|144328515|SUPERIORITY_OR_OTHER|||||||0.017|||||||Chi-squared|||Week 20||||0.017
72410077|NCT00887341|144328515|SUPERIORITY_OR_OTHER|||||||0.451|||||||Chi-squared|||Final visit||||0.451
72410078|NCT00887341|144328516|SUPERIORITY_OR_OTHER|||||||0.377|||||||Chi-squared|||Week 4||||0.377
72410079|NCT00887341|144328516|SUPERIORITY_OR_OTHER|||||||0.387|||||||Chi-squared|||Week 8||||0.387
72576190|NCT00205803|144678728|SUPERIORITY_OR_OTHER||Ratio|1.21|||||TWO_SIDED|95.0|0.69|2.14||||||||2.14|0.69|
72576191|NCT00205803|144678729|SUPERIORITY_OR_OTHER||Ratio|0.97|||||TWO_SIDED|95.0|0.63|1.48||||||||1.48|0.63|
72576192|NCT00205803|144678730|SUPERIORITY_OR_OTHER||Ratio|0.83|||||TWO_SIDED|95.0|0.57|1.21||||||||1.21|0.57|
72410080|NCT00887341|144328516|SUPERIORITY_OR_OTHER|||||||0.304|||||||Chi-squared|||Week 12||||0.304
72410081|NCT00887341|144328516|SUPERIORITY_OR_OTHER|||||||0.509|||||||Chi-squared|||Week 16||||0.509
72410082|NCT00887341|144328516|SUPERIORITY_OR_OTHER|||||||0.11|||||||Chi-squared|||Week 20||||0.110
72410083|NCT00887341|144328516|SUPERIORITY_OR_OTHER|||||||0.504|||||||Chi-squared|||Final visit||||0.504
72410084|NCT00887341|144328517|SUPERIORITY_OR_OTHER|||||||0.327|||||||Chi-squared|||Week 4||||0.327
72410085|NCT00887341|144328517|SUPERIORITY_OR_OTHER|||||||0.786|||||||Chi-squared|||Week 8||||0.786
72410086|NCT00887341|144328517|SUPERIORITY_OR_OTHER|||||||0.482|||||||Chi-squared|||Week 12||||0.482
72410087|NCT00887341|144328517|SUPERIORITY_OR_OTHER|||||||0.68|||||||Chi-squared|||Week 16||||0.680
72410088|NCT00887341|144328517|SUPERIORITY_OR_OTHER|||||||0.69|||||||Chi-squared|||Week 20||||0.690
72410089|NCT00887341|144328517|SUPERIORITY_OR_OTHER|||||||0.516|||||||Chi-squared|||Final Visit||||0.516
72410090|NCT00887341|144328518|SUPERIORITY_OR_OTHER|||||||0.97|||||||Chi-squared|||Week 8||||0.970
72410091|NCT00887341|144328518|SUPERIORITY_OR_OTHER|||||||0.587|||||||Chi-squared|||Week 12||||0.587
72410092|NCT00887341|144328518|SUPERIORITY_OR_OTHER|||||||0.184|||||||Chi-squared|||Week 16||||0.184
72410093|NCT00887341|144328518|SUPERIORITY_OR_OTHER|||||||0.6|||||||Chi-squared|||Week 20||||0.600
72410094|NCT00887341|144328518|SUPERIORITY_OR_OTHER|||||||0.937|||||||Chi-squared|||Final Visit||||0.937
72410095|NCT01591681|144328527|SUPERIORITY_OR_OTHER||||||<|0.001||||||The a priori threshold for statistical significance is 0.05.|Repeated measures regression model|Repeated measures regression model was used accounting for correlated data from the same participant and for the overnight measures.||Sample size was computed to be 45 participants using the system for 42 nights (21 nights with system active and 21 control nights) for a total of 1,890 nights in order to have 90% power with a type 1 error rate of 5% to reject the null hypothesis of no difference in nocturnal hypoglycemia assuming a true population rate of 30% of control nights and 15% of intervention nights with hypoglycemia after adjusting for the correlation from repeated nights and misclassification due to sensor inaccuracy.||||<0.001
72410096|NCT01591681|144328528|SUPERIORITY_OR_OTHER||||||<|0.001||||||The a priori threshold for statistical significance is 0.05.|repeated measures logistic regression|Was used to test differences using mixed effects and a within subject autocorrelation structure to account for multiple nights from the same subject.||||||<0.001
72576193|NCT00205803|144678731|SUPERIORITY_OR_OTHER||Ratio|1.01|||||TWO_SIDED|95.0|0.66|1.53||||||Polio Type 1||1.53|0.66|
72576194|NCT00205803|144678731|SUPERIORITY_OR_OTHER||Ratio|0.91|||||TWO_SIDED|95.0|0.56|1.49||||||Polio Type 2||1.49|0.56|
72576195|NCT00205803|144678731|SUPERIORITY_OR_OTHER||Ratio|1.12|||||TWO_SIDED|95.0|0.69|1.84||||||Polio Type 3||1.84|0.69|
72576196|NCT00205803|144678732|SUPERIORITY_OR_OTHER||Ratio|0.92|||||TWO_SIDED|95.0|0.74|1.15||||||Pertussis - FHA||1.15|0.74|
72576197|NCT00205803|144678732|SUPERIORITY_OR_OTHER||Ratio|1.02|||||TWO_SIDED|95.0|0.83|1.25||||||Pertussis - PT||1.25|0.83|
72410097|NCT01591681|144328529|SUPERIORITY_OR_OTHER||||||<|0.001||||||The a priori threshold for statistical significance is 0.05.|Repeated measures regression model|Repeated measures regression model was used accounting for correlated data from the same participant and for the overnight measures.||||||<0.001
72576198|NCT00205803|144678732|SUPERIORITY_OR_OTHER||Ratio|1.04|||||TWO_SIDED|95.0|0.76|1.44||||||Pertussis - Pertactin||1.44|0.76|
72576199|NCT04080544|144678779|OTHER|Null-hypothesis significance testing|Slope|-1.42|STANDARD_ERROR_OF_MEAN|0.81||0.081|TWO_SIDED|95.0|-3.03|0.18||A priori threshold was two-sided 0.05. No adjustment for multiple comparisons.|Regression, Linear|Adjusted for age, sex, and years of education.||Regression testing the relationship of temporal tau SUVR to episodic memory.||0.18|-3.03|.081
72576200|NCT04080544|144678779|OTHER|Null-hypothesis significance test|Slope|-0.07|STANDARD_ERROR_OF_MEAN|0.13||0.604|TWO_SIDED|95.0|-0.32|0.19||A priori threshold was two-sided 0.05. No adjustment for multiple comparisons.|Regression, Linear|Adjusted for age, sex, and years of education.||Regression testing the interaction of temporal tau SUVR and amyloid SUVR in prediction of episodic memory.||0.19|-0.32|.604
72576201|NCT04080544|144678780|OTHER|Null-hypothesis significance test|Slope|1.77|STANDARD_ERROR_OF_MEAN|0.81||0.033|TWO_SIDED|95.0|0.15|3.39||A priori threshold was two-sided 0.05. No adjustment for multiple comparisons.|Regression, Linear|Adjusted for baseline age, sex, and years of education.||Regression testing the relationship between amyloid accumulation (annualized change score for amyloid SUVR) to temporal tau SUVR.||3.39|0.15|.033
72576202|NCT04080544|144678781|OTHER|Null-hypothesis significance testing|Slope|0.272|STANDARD_ERROR_OF_MEAN|0.7||0.699|TWO_SIDED|95.0|-1.12|1.66||A priori threshold was two-sided 0.05. No adjustment for multiple comparisons.|Regression, Linear|Adjusted for age, sex, and years of education.||Regression testing the relationship of temporal tau SUVR to speed of processing.||1.66|-1.12|.699
72576203|NCT04080544|144678781|OTHER|Null-hypothesis significance test|Slope|0.16|STANDARD_ERROR_OF_MEAN|0.11||0.154|TWO_SIDED|95.0|-0.06|0.38||A priori threshold was two-sided 0.05. No adjustment for multiple comparisons.|Regression, Linear|Adjusted for age, sex, and years of education.||Regression testing the interaction of temporal tau SUVR and amyloid SUVR in the prediction of speed of processing.||0.38|-0.06|.154
72576204|NCT04080544|144678782|OTHER|Null-hypothesis significance testing|Slope|-1.11|STANDARD_ERROR_OF_MEAN|0.74||0.137|TWO_SIDED|95.0|-2.58|0.36||A priori threshold was two-sided 0.05. No adjustment for multiple comparisons.|Regression, Linear|Adjusted for age, sex, and years of education.||Regression testing the relationship of temporal tau SUVR to reasoning function.||0.36|-2.58|.137
72576205|NCT04080544|144678782|OTHER|Null-hypothesis significance test|Slope|0.11|STANDARD_ERROR_OF_MEAN|0.13||0.428|TWO_SIDED|95.0|-0.16|0.37||A priori threshold was two-sided 0.05. No adjustment for multiple comparisons.|Regression, Linear|Adjusted for age, sex, and years of education.||Regression testing the interaction of temporal tau SUVR and amyloid SUVR in prediction of reasoning.||0.37|-0.16|.428
72576206|NCT04080544|144678783|OTHER|Null-hypothesis significance test|Slope|-0.7|STANDARD_ERROR_OF_MEAN|0.78||0.376|TWO_SIDED|95.0|-2.25|0.86||A priori threshold was two-sided 0.05. No adjustment for multiple comparisons.|Regression, Linear|Adjusted for age, sex, and years of education.||Regression testing the relationship of temporal tau SUVR to working memory.||0.86|-2.25|.376
72576207|NCT04080544|144678783|OTHER|Null-hypothesis significance test|Slope|0.27|STANDARD_ERROR_OF_MEAN|0.13||0.039|TWO_SIDED|95.0|0.01|0.53||A priori threshold was two-sided 0.05. No adjustment for multiple comparisons.|Regression, Linear|Adjusted for age, sex, and years of education.||Regression testing the interaction of temporal tau SUVR and amyloid SUVR in prediction of working memory.||0.53|0.01|.039
72576208|NCT04080544|144678783|OTHER|Null-hypothesis significance test|Slope|-0.47|STANDARD_ERROR_OF_MEAN|0.27||0.091|TWO_SIDED|||||A priori threshold was two-sided 0.017 after Bonferroni correction for multiple comparisons (3 post hoc tests).|sim_slopes (R interactions package)|||Post hoc simple slopes test of the amyloid x tau interaction (Statistical Analysis #2) at 1SD below the mean for amyloid||||.091
72576209|NCT04080544|144678783|OTHER|Null-hypothesis significance test|Slope|-0.2|STANDARD_ERROR_OF_MEAN|0.19||0.296|TWO_SIDED|||||A priori threshold was two-sided 0.017 after Bonferroni correction for multiple comparisons (3 post hoc tests).|sim_slopes (R interactions package)|||Post hoc simple slopes test of the amyloid x tau interaction (Statistical Analysis #2) at the mean for amyloid SUVR||||.296
72576210|NCT04080544|144678783|OTHER|Null-hypothesis significance test|Slope|0.07|STANDARD_ERROR_OF_MEAN|0.17||0.695|TWO_SIDED|||||A priori threshold was two-sided 0.017 after Bonferroni correction for multiple comparisons (3 post hoc tests).|sim_slopes (R interactions package)|||Post hoc simple slopes test of the amyloid x tau interaction (Statistical Analysis #2) at 1SD above the mean for amyloid SUVR||||.695
72576211|NCT04080544|144678784|OTHER|Null-hypothesis significance test|Slope|0.002|STANDARD_ERROR_OF_MEAN|0.001||0.012|TWO_SIDED|95.0|0.0004|0.004||A prior threshold was two-sided 0.05. No adjustment for multiple comparisons.|Regression, Linear|No adjustments were made.||Regression testing the relationship of age(linear) to inferior temporal SUVR.||0.004|0.0004|.012
72576212|NCT04080544|144678784|OTHER|Null-hypothesis significance test|Slope|-0.000005|STANDARD_ERROR_OF_MEAN|0.00004||0.905|TWO_SIDED|95.0|-0.000009|0.00008||A priori threshold was two-sided 0.05. No adjustment for multiple comparisons.|Regression, Linear|No adjustments were made.||Regression testing the relationship of age(quadratic) to inferior temporal SUVR.||0.00008|-0.000009|.905
72576213|NCT04080544|144678784|OTHER|Null-hypothesis significance test|Slope|0.002|STANDARD_ERROR_OF_MEAN|0.001||0.006|TWO_SIDED|||||A priori threshold was two-sided 0.05. No adjustment for multiple comparisons.|Regression, Linear|No adjustments were made.||Regression testing the relationship of age(growth model) to inferior temporal SUVR. Growth modeling was performed using SPSS curve estimation.||||.006
72576214|NCT04080544|144678784|OTHER|Null-hypothesis significance test|Slope|0.002|STANDARD_ERROR_OF_MEAN|0.001||0.018|TWO_SIDED|95.0|0.0003|0.003||A priori threshold was two-sided 0.05. No adjustment for multiple comparisons.|Regression, Linear|No adjustments were made.||Regression testing the relationship of age(linear) to middle temporal gyrus SUVR.||0.003|0.0003|.018
72576215|NCT04080544|144678784|OTHER|Null-hypothesis significance test|Slope|-0.00002|STANDARD_ERROR_OF_MEAN|0.00004||0.579|TWO_SIDED|95.0|-0.0001|0.00006||A priori threshold was two-sided 0.05. No adjustment for multiple comparisons.|Regression, Linear|No adjustment for multiple comparisons.||Regression testing the relationship of age(quadratic) to middle temporal SUVR.||0.00006|-0.0001|.579
72627885|NCT00565409|144783965|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.23|||<|0.0001|TWO_SIDED|95.0|1.9|5.6||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 88||5.6|1.9|<0.0001
72627886|NCT00565409|144783966|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 4||||<0.0001
72627887|NCT00565409|144783966|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 8||||<0.0001
72627888|NCT00565409|144783966|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 12||||<0.0001
72627889|NCT00565409|144783966|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|95.0|||||Cochran-Mantel-Haenszel|||Week 20||||<0.0001
72627890|NCT00565409|144783966|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 28||||<0.0001
72627891|NCT00565409|144783966|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 36||||<0.0001
72627892|NCT00565409|144783967|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.14||||0.0089|TWO_SIDED|95.0|0.9|5.2||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 36||5.2|0.9|0.0089
72627893|NCT00565409|144783967|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.87||||0.6932|TWO_SIDED|95.0|0.5|1.7||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 36||1.7|0.5|0.6932
72627894|NCT00565409|144783967|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.76||||0.0019|TWO_SIDED|95.0|1.2|6.1||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 36||6.1|1.2|0.0019
72627895|NCT00565409|144783967|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.53||||0.0797|TWO_SIDED|95.0|0.6|3.6||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 40||3.6|0.6|0.0797
72627896|NCT00565409|144783967|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.9||||0.8103|TWO_SIDED|95.0|0.4|1.9||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 40||1.9|0.4|0.8103
72627897|NCT00565409|144783967|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.87||||0.0903|TWO_SIDED|95.0|0.8|4.5||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 40||4.5|0.8|0.0903
72627898|NCT00565409|144783967|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.02||||0.0035|TWO_SIDED|95.0|1.2|7.8||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 48||7.8|1.2|0.0035
72410098|NCT01591681|144328530|SUPERIORITY_OR_OTHER||||||<|0.001||||||The a priori threshold for statistical significance is 0.05.|Repeated measures regression model|Repeated measures regression model was used accounting for correlated data from the same participant and for the overnight measures.||||||<0.001
72627899|NCT00565409|144783967|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.01||||0.977|TWO_SIDED|95.0|0.5|2.0||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 48||2.0|0.5|0.9770
72627900|NCT00565409|144783967|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.29||||0.0036|TWO_SIDED|95.0|1.3|8.3||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 48||8.3|1.3|0.0036
72627901|NCT00565409|144783967|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.8||||0.0038|TWO_SIDED|95.0|1.0|7.7||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 56||7.7|1.0|0.0038
72627902|NCT00565409|144783967|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.98||||0.9055|TWO_SIDED|95.0|0.5|2.0||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 56||2.0|0.5|0.9055
72627903|NCT00565409|144783967|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.36||||0.002|TWO_SIDED|95.0|1.2|9.8||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 56||9.8|1.2|0.0020
72627904|NCT00565409|144783967|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.35||||0.002|TWO_SIDED|95.0|1.3|8.8||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 64||8.8|1.3|0.0020
72627905|NCT00565409|144783967|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.87||||0.5763|TWO_SIDED|95.0|0.4|1.7||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 64||1.7|0.4|0.5763
72627906|NCT00565409|144783967|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.93||||0.0002|TWO_SIDED|95.0|1.5|10.0||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 64||10.0|1.5|0.0002
72627907|NCT00565409|144783967|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.21||||0.0004|TWO_SIDED|95.0|1.2|8.8||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 72||8.8|1.2|0.0004
72627908|NCT00565409|144783967|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.83||||0.4828|TWO_SIDED|95.0|0.4|1.6||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 72||1.6|0.4|0.4828
72627909|NCT00565409|144783967|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.52|||<|0.0001|TWO_SIDED|95.0|1.4|9.0||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 72||9.0|1.4|<0.0001
72627910|NCT00565409|144783967|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.28||||0.0002|TWO_SIDED|95.0|1.4|7.8||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 80||7.8|1.4|0.0002
72627911|NCT00565409|144783967|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.03||||0.8553|TWO_SIDED|95.0|0.6|1.9||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 80||1.9|0.6|0.8553
72627912|NCT00565409|144783967|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.56||||0.0003|TWO_SIDED|95.0|1.5|8.7||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 80||8.7|1.5|0.0003
72541712|NCT03726437|144613301|SUPERIORITY||Adjusted OR|-0.5|||<|0.05|TWO_SIDED|95.0|-1.27|0.27|||Mixed Models Analysis|Model adjusted for fixed effects.||||0.27|-1.27|<.05
72541713|NCT03726437|144613302|SUPERIORITY||Incidence rate ratio|0.81||||0.02|TWO_SIDED|95.0|0.67|0.97|||Mixed Models Analysis|Model adjusted for fixed effects.||||.97|.67|.02
72541714|NCT03726437|144613303|SUPERIORITY||Incidence rate ratio|1.05||||0.43|TWO_SIDED|95.0|0.92|1.2|||Mixed Models Analysis|Model adjusted for fixed effects.||||1.20|.92|.43
72541715|NCT03726437|144613304|SUPERIORITY||Adjusted OR|1.72||||0.006|TWO_SIDED|95.0|1.17|2.55|||Mixed Models Analysis|Model adjusted for fixed effects.||||2.55|1.17|.006
72541716|NCT00068445|144613305|SUPERIORITY|||||||0.56|||||||Wilcoxon (Mann-Whitney)|||||||0.56
72541717|NCT00068445|144613306|SUPERIORITY|||||||0.36|||||||Wilcoxon (Mann-Whitney)|||||||0.36
72541718|NCT00068445|144613307|SUPERIORITY|||||||0.25|||||||Wilcoxon (Mann-Whitney)|||||||0.25
72541719|NCT00068445|144613308|SUPERIORITY|||||||0.34|||||||Wilcoxon (Mann-Whitney)|||||||0.34
72541720|NCT00068445|144613309|SUPERIORITY|||||||0.53|||||||Wilcoxon (Mann-Whitney)|||||||0.53
72541721|NCT00068445|144613310|SUPERIORITY|||||||0.22|||||||Wilcoxon (Mann-Whitney)|||||||0.22
72541722|NCT00068445|144613311|SUPERIORITY|||||||0.33|||||||Wilcoxon (Mann-Whitney)|||||||0.33
72541723|NCT00068445|144613312|SUPERIORITY|||||||0.07|||||||Wilcoxon (Mann-Whitney)|||||||0.07
72541724|NCT00068445|144613313|SUPERIORITY|||||||0.91|||||||Wilcoxon (Mann-Whitney)|||||||0.91
72541725|NCT00068445|144613314|SUPERIORITY|||||||0.68|||||||Wilcoxon (Mann-Whitney)|||||||0.68
72541726|NCT00423488|144613323|SUPERIORITY_OR_OTHER_LEGACY||least-squares means|-11.5||||0.005||95.0|-19.4|-3.5|||ANOVA|The analysis of variance (ANOVA) model included term of treatment effect. If more than one basal value was available, the latest was used.||||-3.5|-19.4|0.005
72541727|NCT03118765|144613325|OTHER|ANOVA|LS mean ratio (%)|29.4|||||TWO_SIDED|90.0|21.14|41.0|||||Relative Bioavailability (%) based on CmaxSS for of GSP304 in comparison to SPIRIVA RESPIMAT|GSP 304 vs SPIRIVA RESPIMAT 5 μg comparison for relative bioavailability data based on CmaxSS was tested and the estimated treatment ratios for the treatment comparisons was presented.||41.00|21.14|
72541728|NCT03118765|144613325|OTHER|ANOVA|LS mean ratio (%)|57.0|||||TWO_SIDED|90.0|41.37|78.46|||||Relative Bioavailability (%) based on CmaxSS for of GSP304 in comparison to SPIRIVA RESPIMAT|GSP 304 vs SPIRIVA RESPIMAT 5 μg comparison for relative bioavailability data based on CmaxSS was tested and the estimated treatment ratios for the treatment comparisons was presented.||78.46|41.37|
72541729|NCT03118765|144613325|OTHER|ANOVA|LS mean ratio (%)|155.8|||||TWO_SIDED|90.0|111.88|216.99|||||Relative Bioavailability (%) based on CmaxSS for of GSP304 in comparison to SPIRIVA RESPIMAT|GSP 304 vs SPIRIVA RESPIMAT 5 μg comparison for relative bioavailability data based on CmaxSS was tested and the estimated treatment ratios for the treatment comparisons was presented.||216.99|111.88|
72541730|NCT03118765|144613326|OTHER|ANOVA|LS mean ratio (%)|39.7|||||TWO_SIDED|90.0|29.79|52.87|||||Relative Bioavailability (%) based on AUC0-tauSS for of GSP304 in comparison to SPIRIVA RESPIMAT|GSP 304 vs SPIRIVA RESPIMAT 5 μg comparison for relative bioavailability data based on AUC0-tauSS was tested and the estimated treatment ratios for the treatment comparisons was presented.||52.87|29.79|
72410099|NCT01591681|144328531|SUPERIORITY_OR_OTHER||||||<|0.001||||||The a priori threshold for statistical significance is 0.05.|Repeated measures regression model|Repeated measures regression model was used accounting for correlated data from the same participant and for the overnight measures.||||||<0.001
72541731|NCT03118765|144613326|OTHER|ANOVA|LS mean ratio (%)|85.2|||||TWO_SIDED|90.0|64.43|112.64|||||Relative Bioavailability (%) based on AUC0-tauSS for of GSP304 in comparison to SPIRIVA RESPIMAT|GSP 304 vs SPIRIVA RESPIMAT 5 μg comparison for relative bioavailability data based on AUC0-tauSS was tested and the estimated treatment ratios for the treatment comparisons was presented.||112.64|64.43|
72541732|NCT03118765|144613326|OTHER|ANOVA|LS mean ratio (%)|211.5|||||TWO_SIDED|90.0|158.8|281.8|||||Relative Bioavailability (%) based on AUC0-tauSS for of GSP304 in comparison to SPIRIVA RESPIMAT|GSP 304 vs SPIRIVA RESPIMAT 5 μg comparison for relative bioavailability data based on AUC0-tauSS was tested and the estimated treatment ratios for the treatment comparisons was presented.||281.80|158.80|
72541733|NCT03118765|144613327|SUPERIORITY||Mean Difference (Final Values)|0.06||||0.228|TWO_SIDED|95.0|-0.04|0.17|||MMRM|||GSP 304 vs Placebo comparison for change from baseline in trough FEV1 was tested at 0.05 significance level.||0.17|-0.04|0.228
72541734|NCT03118765|144613327|SUPERIORITY||Mean Difference (Net)|0.02||||0.655|TWO_SIDED|95.0|-0.08|0.13|||MMRM|||GSP 304 vs Placebo comparison for change from baseline in trough FEV1 was tested at 0.05 significance level.||0.13|-0.08|0.655
72541735|NCT03118765|144613327|SUPERIORITY||Mean Difference (Final Values)|0.01||||0.894|TWO_SIDED|95.0|-0.1|0.11|||MMRM|||GSP 304 vs Placebo comparison for change from baseline in trough FEV1 was tested at 0.05 significance level.||0.11|-0.10|0.894
72541736|NCT03118765|144613327|SUPERIORITY||Mean Difference (Final Values)|0.06||||0.26|TWO_SIDED|95.0|-0.04|0.16|||MMRM|||SPIRIVA RESPIMAT 5 μg vs Placebo comparison for change from baseline in trough FEV1 was tested at 0.05 significance level.||0.16|-0.04|0.260
72541737|NCT03118765|144613328|OTHER||||||||||||||||||The mean amount of tiotropium excreted in urine over the dosing interval on Day 1 for GSP304 10 μg was (Geo mean: 108200 pg) and for SPIRIVA RESPIMAT 5 μg was (Geo mean: 120300 pg).|||
72541738|NCT03118765|144613328|OTHER||||||||||||||||||The mean amount of tiotropium excreted in urine over the dosing interval on Day 1 for GSP304 20 μg was (Geo mean: 263100 pg) and for SPIRIVA RESPIMAT 5 μg was (Geo mean: 120300 pg).|||
72541739|NCT03118765|144613328|OTHER||||||||||||||||||The mean amount of tiotropium excreted in urine over the dosing interval on Day 1 for GSP304 40 μg was (Geo mean: 438300 pg) and for SPIRIVA RESPIMAT 5 μg was (Geo mean: 120300 pg).|||
72541740|NCT03118765|144613329|OTHER||||||||||||||||||The mean amount of tiotropium excreted in urine over the dosing interval on Day 21 for GSP304 10 μg was (Geo mean: 293700 pg) and for SPIRIVA RESPIMAT 5 μg was (Geo mean: 620200 pg).|||
72541741|NCT03118765|144613329|OTHER||||||||||||||||||The mean amount of tiotropium excreted in urine over the dosing interval on Day 21 for GSP304 20 μg was (Geo mean: 436500 pg) and for SPIRIVA RESPIMAT 5 μg was (Geo mean: 620200 pg).|||
72541742|NCT03118765|144613329|OTHER||||||||||||||||||The mean amount of tiotropium excreted in urine over the dosing interval on Day 21 for GSP304 40 μg was (Geo mean: 1249000 pg) and for SPIRIVA RESPIMAT 5 μg was (Geo mean: 620200 pg).|||
72541743|NCT03118765|144613330|OTHER||||||||||||||||||For GSP304 10 μg, the geometric mean Fe (%) eliminated in urine was 1.082% on Day 1 and for SPIRIVA RESPIMAT 5 μg, the geometric mean Fe (%) eliminated in urine was 2.407% on Day 1|||
72541744|NCT03118765|144613330|OTHER||||||||||||||||||For GSP304 20 μg, the geometric mean Fe (%) eliminated in urine was 1.316% on Day 1 and for SPIRIVA RESPIMAT 5 μg, the geometric mean Fe (%) eliminated in urine was 2.407% on Day 1|||
72541745|NCT03118765|144613330|OTHER||||||||||||||||||For GSP304 40 μg, the geometric mean Fe (%) eliminated in urine was 1.096% on Day 1 and for SPIRIVA RESPIMAT 5 μg, the geometric mean Fe (%) eliminated in urine was 2.407% on Day 1|||
72541746|NCT03118765|144613331|OTHER||||||||||||||||||For GSP304 10 μg, the geometric mean Fe (%) eliminated in urine was 2.937% on Day 21 and for SPIRIVA RESPIMAT 5 μg, the geometric mean Fe (%) eliminated in urine was 12.4% on Day 21|||
72541747|NCT03118765|144613331|OTHER||||||||||||||||||For GSP304 20 μg, the geometric mean Fe (%) eliminated in urine was 2.183% on Day 21 and for SPIRIVA RESPIMAT 5 μg, the geometric mean Fe (%) eliminated in urine was 12.4% on Day 21|||
72541748|NCT03118765|144613331|OTHER||||||||||||||||||For GSP304 40 μg, the geometric mean Fe (%) eliminated in urine was 3.123% on Day 21 and for SPIRIVA RESPIMAT 5 μg, the geometric mean Fe (%) eliminated in urine was 12.4% on Day 21|||
72541749|NCT03118765|144613332|OTHER||||||||||||||||||For GSP304 10 μg, geometric mean Cmax of tiotropium was 2.191 pg/mL and for SPIRIVA RESPIMAT 5 μg, geometric mean Cmax of tiotropium was 7.327 pg/mL on Day 1.|||
72541750|NCT03118765|144613332|OTHER||||||||||||||||||For GSP304 20 μg, geometric mean Cmax of tiotropium was 4.796 pg/mL and for SPIRIVA RESPIMAT 5 μg, geometric mean Cmax of tiotropium was 7.327 pg/mL on Day 1.|||
72541751|NCT03118765|144613332|OTHER||||||||||||||||||For GSP304 40 μg, geometric mean Cmax of tiotropium was 10.2 pg/mL and for SPIRIVA RESPIMAT 5 μg, geometric mean Cmax of tiotropium was 7.327 pg/mL on Day 1.|||
72541752|NCT03118765|144613333|OTHER||||||||||||||||||For GSP304 10 μg, geometric mean AUC0-tau of tiotropium was 8.597 pg\*h/mL and for SPIRIVA RESPIMAT 5 μg, geometric mean AUC0-tau of tiotropium was 19.59 pg\*h/mL on Day 1.|||
72541753|NCT03118765|144613333|OTHER||||||||||||||||||For GSP304 20 μg, geometric mean AUC0-tau of tiotropium was 18.00 pg\*h/mL and for SPIRIVA RESPIMAT 5 μg, geometric mean AUC0-tau of tiotropium was 19.59 pg\*h/mL on Day 1.|||
72541754|NCT03118765|144613333|OTHER||||||||||||||||||For GSP304 40 μg, geometric mean AUC0-tau of tiotropium was 42.69 pg\*h/mL and for SPIRIVA RESPIMAT 5 μg, geometric mean AUC0-tau of tiotropium was 19.59 pg\*h/mL on Day 1.|||
72541755|NCT03118765|144613336|OTHER||||||||||||||||||For GSP304 10 μg, the geometric mean CavSS was 0.9536 pg/mL on Day 21 and for SPIRIVA RESPIMAT 5 μg, the CavSS was 2.403 pg/mL on Day 21|||
72541756|NCT03118765|144613336|OTHER||||||||||||||||||For GSP304 20 μg, the geometric mean CavSS was 1.998 pg/mL on Day 21 and for SPIRIVA RESPIMAT 5 μg, the CavSS was 2.403 pg/mL on Day 21|||
72541757|NCT03118765|144613336|OTHER||||||||||||||||||For GSP304 40 μg, the geometric mean CavSS was 5.083 pg/mL on Day 21 and for SPIRIVA RESPIMAT 5 μg, the CavSS was 2.403 pg/mL on Day 21|||
72541758|NCT03118765|144613337|OTHER||||||||||||||||||Upon repeat dosing, tiotropium had accumulated by Day 21 with a geometric mean accumulation ratio (Rac) based on AUC of 2.617 for GSP304 10 μg and 2.815 for SPIRIVA RESPIMAT 5 μg.|||
72541759|NCT03118765|144613337|OTHER||||||||||||||||||Upon repeat dosing, tiotropium had accumulated by Day 21 with a geometric mean accumulation ratio (Rac) based on AUC of 2.522 for GSP304 20 μg and 2.815 for SPIRIVA RESPIMAT 5 μg.|||
72541760|NCT03118765|144613337|OTHER||||||||||||||||||Upon repeat dosing, tiotropium had accumulated by Day 21 with a geometric mean accumulation ratio (Rac) based on AUC of 2.926 for GSP304 40 μg and 2.815 for SPIRIVA RESPIMAT 5 μg.|||
72627913|NCT00565409|144783967|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.53|||<|0.0001|TWO_SIDED|95.0|1.6|7.6||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 88||7.6|1.6|<0.0001
72627914|NCT00565409|144783967|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.12||||0.5025|TWO_SIDED|95.0|0.6|2.0||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 88||2.0|0.6|0.5025
72627915|NCT00565409|144783967|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.62||||0.0001|TWO_SIDED|95.0|1.6|8.1||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 88||8.1|1.6|0.0001
72627916|NCT02347605|144784029|SUPERIORITY|||||||0.25||||||Adjusted for treatment order, session, room sequence|Mixed Models Analysis|||||||0.25
72627917|NCT02347605|144784030|SUPERIORITY|||||||0.18||||||Adjusted for treatment order, session, room sequence|Mixed Models Analysis|||||||0.18
72627918|NCT01918189|144784033|OTHER|Mixed models (using an unstructured correlation structure) regression over the baseline and 10-week post-baseline follow-up assessments were used to examine change in outcome measures for preliminary efficacy variables. The primary endpoint for the preliminary efficacy analyses is the mean difference in baseline to post-baseline follow-up scores on the primary measure of pain interference (i.e., WHYMPI-Interference Scale) at 10 weeks post-baseline.||||||0.008||||||a priori threshold for statistical significance is p \<0.05|Regression, Logistic|||||||0.008
72541761|NCT03118765|144613338|OTHER||||||||||||||||||Upon repeat dosing, tiotropium had accumulated by Day 21 with a geometric mean accumulation ratio (Rac) based on Cmax of 1.944 for GSP304 10 μg and 1.929 for SPIRIVA RESPIMAT 5 μg.|||
72541762|NCT03118765|144613338|OTHER||||||||||||||||||Upon repeat dosing, tiotropium had accumulated by Day 21 with a geometric mean accumulation ratio (Rac) based on Cmax of 1.808 for GSP304 20 μg and 1.929 for SPIRIVA RESPIMAT 5 μg.|||
72541763|NCT03118765|144613338|OTHER||||||||||||||||||Upon repeat dosing, tiotropium had accumulated by Day 21 with a geometric mean accumulation ratio (Rac) based on Cmax of 2.125 for GSP304 40 μg and 1.929 for SPIRIVA RESPIMAT 5 μg.|||
72541764|NCT03118765|144613339|SUPERIORITY||Mean Difference (Final Values)|0.13||||0.004|TWO_SIDED|95.0|0.04|0.21|||Mixed Models Analysis|||||0.21|0.04|0.004
72541765|NCT03118765|144613339|SUPERIORITY||Mean Difference (Final Values)|0.17|||<|0.001|TWO_SIDED|95.0|0.08|0.26|||Mixed Models Analysis|||||0.26|0.08|<0.001
72541766|NCT03118765|144613339|SUPERIORITY||Mean Difference (Final Values)|0.12||||0.007|TWO_SIDED|95.0|0.03|0.21|||Mixed Models Analysis|||||0.21|0.03|0.007
72541767|NCT03118765|144613339|SUPERIORITY||Mean Difference (Final Values)|0.17|||<|0.001|TWO_SIDED|95.0|0.08|0.26|||Mixed Models Analysis|||||0.26|0.08|<0.001
72541768|NCT03118765|144613340|SUPERIORITY||Mean Difference (Final Values)|0.18||||0.001|TWO_SIDED|95.0|0.08|0.28|||Mixed Models Analysis|||||0.28|0.08|0.001
72541769|NCT03118765|144613340|SUPERIORITY||Mean Difference (Final Values)|0.15||||0.005|TWO_SIDED|95.0|0.05|0.25|||Mixed Models Analysis|||||0.25|0.05|0.005
72541770|NCT03118765|144613340|SUPERIORITY||Mean Difference (Final Values)|0.11||||0.032|TWO_SIDED|95.0|0.01|0.21|||Mixed Models Analysis|||||0.21|0.01|0.032
72541771|NCT03118765|144613340|SUPERIORITY||Mean Difference (Final Values)|0.17||||0.001|TWO_SIDED|95.0|0.07|0.27|||Mixed Models Analysis|||||0.27|0.07|0.001
72541772|NCT03118765|144613341|SUPERIORITY||Mean Difference (Final Values)|0.09||||0.166|TWO_SIDED|95.0|-0.04|0.21|||Mixed Models Analysis|||||0.21|-0.04|0.166
72541773|NCT03118765|144613341|SUPERIORITY||Mean Difference (Final Values)|0.08||||0.182|TWO_SIDED|95.0|-0.04|0.21|||Mixed Models Analysis|||||0.21|-0.04|0.182
72541774|NCT03118765|144613341|SUPERIORITY||Mean Difference (Final Values)|0.05||||0.401|TWO_SIDED|95.0|-0.07|0.17|||Mixed Models Analysis|||||0.17|-0.07|0.401
72541775|NCT03118765|144613341|SUPERIORITY||Mean Difference (Final Values)|0.03||||0.574|TWO_SIDED|95.0|-0.09|0.16|||Mixed Models Analysis|||||0.16|-0.09|0.574
72541776|NCT03118765|144613342|SUPERIORITY||Mean Difference (Final Values)|0.05||||0.493|TWO_SIDED|95.0|-0.1|0.21|||Mixed Models Analysis|||||0.21|-0.10|0.493
72541777|NCT03118765|144613342|SUPERIORITY||Mean Difference (Final Values)|-0.01||||0.864|TWO_SIDED|95.0|-0.17|0.14|||Mixed Models Analysis|||||0.14|-0.17|0.864
72541778|NCT03118765|144613342|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.978|TWO_SIDED|95.0|-0.16|0.15|||Mixed Models Analysis|||||0.15|-0.16|0.978
72627919|NCT01918189|144784034|OTHER|Mixed models (using an unstructured correlation structure) regression over the baseline and 10-week post-baseline follow-up assessments were used to examine change in outcome measures for preliminary efficacy variables. The primary endpoint for the preliminary efficacy analyses is the mean difference in baseline to post-baseline follow-up scores on the primary measure of pain intensity at 10 weeks post-baseline.|Mean Difference (Final Values)|0.05||||0.27|TWO_SIDED|95.0||||a priori threshold for statistical significance is p\<0.05|Regression, Logistic|||||||0.27
72627920|NCT01918189|144784035|OTHER|Mixed models (using an unstructured correlation structure) regression over the baseline and 10-week post-baseline follow-up assessments were used to examine change in outcome measures for preliminary efficacy variables. The primary endpoint for the preliminary efficacy analyses is the mean difference in baseline to post-baseline follow-up scores on the measure of mood symptoms at 10 weeks post-baseline.|Mean Difference (Net)|0.05||||0.02|TWO_SIDED|95.0||||a priori threshold for statistical significance is p\<0.05|Regression, Logistic|||||||0.02
72410100|NCT01591681|144328532|SUPERIORITY_OR_OTHER|||||||0.71||||||The a priori threshold for statistical significance is 0.05.|repeated measures logistic regression|Was used to test differences using mixed effects and a within subject autocorrelation structure to account for multiple nights from the same subject.||||||0.71
72541779|NCT03118765|144613342|SUPERIORITY||Mean Difference (Final Values)|0.05||||0.5|TWO_SIDED|95.0|-0.1|0.2|||Mixed Models Analysis|||||0.20|-0.10|0.500
72541780|NCT03118765|144613343|SUPERIORITY||Mean Difference (Final Values)|0.12||||0.003|TWO_SIDED|95.0|0.04|0.2|||Mixed Models Analysis|||||0.20|0.04|0.003
72541781|NCT03118765|144613343|SUPERIORITY||Mean Difference (Final Values)|0.14||||0.001|TWO_SIDED|95.0|0.06|0.22|||Mixed Models Analysis|||||0.22|0.06|0.001
72541782|NCT03118765|144613343|SUPERIORITY||Mean Difference (Final Values)|0.13||||0.001|TWO_SIDED|95.0|0.06|0.21|||Mixed Models Analysis|||||0.21|0.06|0.001
72541783|NCT03118765|144613343|SUPERIORITY||Mean Difference (Final Values)|0.16|||<|0.001|TWO_SIDED|95.0|0.08|0.23|||Mixed Models Analysis|||||0.23|0.08|<0.001
72541784|NCT03118765|144613344|SUPERIORITY||Mean Difference (Final Values)|0.15||||0.002|TWO_SIDED|95.0|0.06|0.24|||Mixed Models Analysis|||||0.24|0.06|0.002
72541785|NCT03118765|144613344|SUPERIORITY||Mean Difference (Final Values)|0.09||||0.061|TWO_SIDED|95.0|0.0|0.18|||Mixed Models Analysis|||||0.18|-0.00|0.061
72541786|NCT03118765|144613344|SUPERIORITY||Mean Difference (Final Values)|0.07||||0.14|TWO_SIDED|95.0|-0.02|0.16|||Mixed Models Analysis|||||0.16|-0.02|0.140
72541787|NCT03118765|144613344|SUPERIORITY||Mean Difference (Final Values)|0.15||||0.002|TWO_SIDED|95.0|0.06|0.24|||Mixed Models Analysis|||||0.24|0.06|0.002
72541788|NCT00947518|144613359|SUPERIORITY_OR_OTHER|||||||0.99|TWO_SIDED|95.0|||||Kruskal-Wallis|||||||0.99
72541789|NCT00947518|144613360|SUPERIORITY_OR_OTHER|||||||0.46||95.0|||||ANOVA|||||||0.46
72541790|NCT00947518|144613361|SUPERIORITY_OR_OTHER|||||||0.06||95.0|||||Chi-squared|||||||0.06
72541791|NCT00947518|144613362|SUPERIORITY||||||<|0.05|||||||Chi-squared||||For comparison of categorical variables among the three groups, Chi2 test followed by Bonferroni's correction was used.|||<0.05
72576216|NCT04080544|144678784|OTHER|Null-hypothesis significance test|Slope|0.002|STANDARD_ERROR_OF_MEAN|0.001||0.008|TWO_SIDED|||||A priori threshold was two-sided 0.05. No adjustment for multiple comparisons.|Regression, Linear|No adjustments were made.||Regression testing the relationship of age(growth model) to middle temporal SUVR. Growth modeling was performed using SPSS curve estimation.||||.008
72576217|NCT04080544|144678784|OTHER|Null-hypothesis significance test|Slope|0.00006|STANDARD_ERROR_OF_MEAN|0.0004||0.897|TWO_SIDED|95.0|-0.001|0.001||A priori threshold was two-sided 0.05. No adjustment for multiple comparisons.|Regression, Linear|No adjustments were made.||Regression testing the relationship of age to superior temporal SUVR.||0.001|-0.001|.897
72576218|NCT04080544|144678784|OTHER|Null-hypothesis significance test|Slope|-0.00002|STANDARD_ERROR_OF_MEAN|0.00003||0.539|TWO_SIDED|95.0|-0.00007|0.00003||A priori threshold was two-sided 0.05. No adjustment for multiple comparisons.|Regression, Linear|No adjustments were made.||Regression testing the relationship of age(quadratic) to superior temporal SUVR.||0.00003|-0.00007|.539
72576219|NCT04080544|144678784|OTHER|Null-hypothesis significance test|Slope|-0.00001|STANDARD_ERROR_OF_MEAN|0.0004||0.973|TWO_SIDED|||||A priori threshold was two-sided 0.05. No adjustment for multiple comparisons.|Regression, Linear|No adjustments were made.||Regression testing the relationship of age(growth model) to superior temporal SUVR. Growth modeling was performed using SPSS curve estimation.||||.973
72576220|NCT04080544|144678784|OTHER|Null-hypothesis significance test|Slope|0.001|STANDARD_ERROR_OF_MEAN|0.001||0.2|TWO_SIDED|95.0|-0.001|0.003||A priori threshold was two-sided 0.05. No adjustment for multiple comparisons.|Regression, Linear|No adjustments were made.||Regression testing the relationship of age(linear) to entorhinal SUVR.||0.003|-0.001|.200
72576221|NCT04080544|144678784|OTHER|Null-hypothesis significance test|Slope|0.00005|STANDARD_ERROR_OF_MEAN|0.00005||0.346|TWO_SIDED|95.0|-0.00005|0.0001||A priori threshold was two-sided 0.05. No adjustment for multiple comparisons.|Regression, Linear|No adjustments were made.||Regression testing the relationship of age(quadratic) to entorhinal SUVR.||0.0001|-0.00005|.346
72410101|NCT01591681|144328533|SUPERIORITY_OR_OTHER|||||||0.62||||||The a priori threshold for statistical significance is 0.05.|repeated measures logistic regression|Was used to test differences using mixed effects and a within subject autocorrelation structure to account for multiple nights from the same subject.||||||0.62
72410102|NCT01591681|144328534|SUPERIORITY_OR_OTHER|||||||0.1||||||The a priori threshold for statistical significance is 0.05.|repeated measures logistic regression|Was used to test differences using mixed effects and a within subject autocorrelation structure to account for multiple nights from the same subject.||||||0.10
72576222|NCT04080544|144678784|OTHER|Null-hypothesis significance test|Slope|0.001|STANDARD_ERROR_OF_MEAN|0.001||0.283|TWO_SIDED|||||A priori threshold was two-sided 0.05. No adjustment for multiple comparisons.|Regression, Linear|No adjustments were made.||Regression testing relationship of age(growth model) to entorhinal SUVR. Growth modeling was performed using SPSS curve estimation.||||.283
72576223|NCT04080544|144678784|OTHER|Null-hypothesis significance test|Slope|0.002|STANDARD_ERROR_OF_MEAN|0.001||0.011|TWO_SIDED|95.0|0.0004|0.003||A priori threshold was two-sided 0.05. No adjustment for multiple comparisons.|Regression, Linear|No adjustments were made.||Regression testing the relationship of age(linear) to parahippocampal SUVR.||0.003|0.0004|.011
72576224|NCT04080544|144678784|OTHER|Null-hypothesis significance test|Slope|0.00002|STANDARD_ERROR_OF_MEAN|0.00003||0.536|TWO_SIDED|95.0|-0.00004|0.00009||A priori threshold was two-sided 0.05. No adjustment for multiple comparisons.|Regression, Linear|No adjustments were made.||Regression testing the relationship of age(quadratic) to parahippocampal SUVR.||0.00009|-0.00004|.536
72576225|NCT04080544|144678784|OTHER|Null-hypothesis significance test|Slope|0.001|STANDARD_ERROR_OF_MEAN|0.001||0.013|TWO_SIDED|||||A priori threshold was two-sided 0.05. No adjustment for multiple comparisons.|Regression, Linear|No adjustments were made.||Regression testing the relationship of age(growth model) to parahippocampal SUVR. Growth modeling was performed using SPSS curve estimation.||||.013
72576226|NCT04080544|144678784|OTHER|Null-hypothesis significance test|Slope|0.002|STANDARD_ERROR_OF_MEAN|0.0005|<|0.001|TWO_SIDED|95.0|0.001|0.003||A priori threshold was two-sided 0.05. No adjustment for multiple comparisons.|Regression, Linear|No adjustments were made.||Regression testing the relationship of age(linear) to fusiform SUVR.||0.003|0.001|<.001
72576227|NCT04080544|144678784|OTHER|Null-hypothesis significance test|Slope|0.00001|STANDARD_ERROR_OF_MEAN|0.00003||0.692|TWO_SIDED|95.0|-0.00004|0.00006||A priori threshold was two-sided 0.05. No adjustment for multiple comparisons.|Regression, Linear|No adjustments were made.||Regression testing the relationship of age(quadratic) to fusiform SUVR.||0.00006|-0.00004|.692
72576228|NCT04080544|144678784|OTHER|Null-hypothesis significance test|Slope|0.001|STANDARD_ERROR_OF_MEAN|0.0004|<|0.001|TWO_SIDED|||||A priori threshold was two-sided 0.05. No adjustment for multiple comparisons.|Regression, Linear|No adjustments were made.||Regression testing the relationship of age(growth model) to fusiform SUVR. Growth modeling was performed using SPSS curve estimation.||||<.001
72576229|NCT04080544|144678785|OTHER|Null-hypothesis significance testing|Slope|0.18|STANDARD_ERROR_OF_MEAN|0.18||0.331|TWO_SIDED|95.0|-0.18|0.53||A priori threshold was two-sided 0.05. No adjustment for multiple comparisons.|Regression, Linear|Adjusted for age, sex, and years of education.||Regression testing the relationship of temporal tau SUVR to inferior temporal gyrus cortical thickness.||0.53|-0.18|.331
72576230|NCT04080544|144678785|OTHER|Null-hypothesis significance testing|Slope|0.07|STANDARD_ERROR_OF_MEAN|0.16||0.636|TWO_SIDED|95.0|-0.24|0.39||A priori threshold was two-sided 0.05. No adjustment for multiple comparisons.|Regression, Linear|Adjusted for age, sex, and years of education||Regression testing the relationship between temporal tau SUVR to middle temporal gyrus cortical thickness.||0.39|-0.24|.636
72576231|NCT04080544|144678785|OTHER|Null-hypothesis significance testing|Slope|0.38|STANDARD_ERROR_OF_MEAN|0.16||0.024|TWO_SIDED|95.0|0.05|0.7||A priori threshold was two-sided 0.05. No adjustment for multiple comparisons.|Regression, Linear|Adjusted for age, sex, and years of education.||Regression testing the relationship between temporal tau SUVR to superior temporal gyrus cortical thickness.||0.70|0.05|.024
72541792|NCT01749033|144613388|SUPERIORITY_OR_OTHER_LEGACY|||||||0.76|||||||Chi-squared|||We planned a sample size of 429 to achieve a 80% power to detect an effect size difference of w=0.15 using 2 degrees of freedom chi-square test with a significance level (alpha) of .05.||||.76
72541793|NCT01749033|144613390|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.02||||0.05|TWO_SIDED||||||Chi-squared||The reported p value was calculated.|We planned a sample size of 429 to achieve a 80% power to detect an effect size difference of w=0.15 using 2 degrees of freedom chi-square test with a significance level (alpha) of .05.||||.05
72541794|NCT03125915|144613420|SUPERIORITY||Beta|-3.62||||0.03|TWO_SIDED|95.0|-6.78|-0.46||A multi-level latent growth curve (LGC) with a intercept and linear slope was specified. The main effects of SUM and CT video were modeled at level 2 in addition to their interaction. Drug use was specified as a binomial distribution.|multi-leve latent growth curve||For 1-Month Follow-Up, substance use module (SUM) among those who did not view CT Video|||-0.46|-6.78|.03
72541795|NCT03125915|144613420|SUPERIORITY||Beta|-1.67||||0.18|TWO_SIDED|95.0|-4.1|0.76||A multi-level latent growth curve (LGC) with an intercept and linear slope was specified. The main effects of SUM and CT video were modeled at level 2 in addition to their interaction. Drug use was specified as a binomial distribution.|multi-level latent growth curve||1-month follow-up, effect of SUM among those who did view the CT video.|||0.76|-4.10|.18
72541796|NCT03125915|144613420|SUPERIORITY||Beta|-0.35||||0.75|TWO_SIDED|95.0|-2.5|1.8||A multi-level latent growth curve (LGC) with an intercept and linear slope was specified. The main effects of SUM and CT video were modeled at level 2 in addition to their interaction. Drug use was specified as a binomial distribution.|multi-level latent growth curve||1-month follow up, effect of CT video among those who completed the SUM.|||1.80|-2.50|0.75
72541797|NCT03125915|144613420|SUPERIORITY||Beta|-2.3||||0.14|TWO_SIDED|95.0|-5.37|0.77||A multi-level latent growth curve (LGC) with an intercept and linear slope was specified. The main effects of SUM and CT video were modeled at level 2 in addition to their interaction. Drug use was specified as a binomial distribution.|multi-level latent growth curve||1-Month follow up, effect of CT video among those who did not complete SUM.|||0.77|-5.37|0.14
72541798|NCT03125915|144613420|SUPERIORITY||Beta|-2.79||||0.013|TWO_SIDED|95.0|-5.0|-0.58||A multi-level latent growth curve (LGC) with an intercept and linear slope was specified. The main effects of SUM and CT video were modeled at level 2 in addition to their interaction. Drug use was specified as a binomial distribution.|multi-level latent growth curve||3-Month follow up, effect of SUM among those who viewed the CT video.|||-0.58|-5.00|0.013
72541799|NCT03125915|144613420|SUPERIORITY||Beta|-2.09||||0.1|TWO_SIDED|95.0|-4.56|0.38||A multi-level latent growth curve (LGC) with an intercept and linear slope was specified. The main effects of SUM and CT video were modeled at level 2 in addition to their interaction. Drug use was specified as a binomial distribution.|multi-level latent growth curve||3-Month follow up, effect of SUM among those who did not view CT video|||0.38|-4.56|0.10
72541800|NCT03125915|144613420|SUPERIORITY||Beta|0.4||||0.78|TWO_SIDED|95.0|-2.35|3.16||A multi-level latent growth curve (LGC) with an intercept and linear slope was specified. The main effects of SUM and CT video were modeled at level 2 in addition to their interaction. Drug use was specified as a binomial distribution.|multi-level latent growth curve||3-month follow-up, effect of CT Video among those who completed the SUM|A multi-level latent growth curve (LGC) with an intercept and linear slope was specified. The main effects of SUM and CT video were modeled at level 2 in addition to their interaction. Drug use was specified as a binomial distribution.||3.16|-2.35|0.78
72541801|NCT03125915|144613420|SUPERIORITY||Beta|-0.3||||0.75|TWO_SIDED|95.0|-2.12|1.53||A multi-level latent growth curve (LGC) with an intercept and linear slope was specified. The main effects of SUM and CT video were modeled at level 2 in addition to their interaction. Drug use was specified as a binomial distribution.|multi-level latent growth curve||3-month follow-up, effect of CT video among those who did not complete SUM.|||1.53|-2.12|0.75
72541802|NCT03125915|144613420|SUPERIORITY||Beta|-3.93||||0.014|TWO_SIDED|95.0|-7.06|-0.81||A multi-level latent growth curve (LGC) with an intercept and linear slope was specified. The main effects of SUM and CT video were modeled at level 2 in addition to their interaction. Drug use was specified as a binomial distribution.|multi-level latent growth curve||6-month follow-up, effects of SUM among those who viewed the CT video.|||-0.81|-7.06|0.014
72541803|NCT03125915|144613420|SUPERIORITY||Beta|-0.57||||0.67|TWO_SIDED|95.0|-3.16|2.03||A multi-level latent growth curve (LGC) with an intercept and linear slope was specified. The main effects of SUM and CT video were modeled at level 2 in addition to their interaction. Drug use was specified as a binomial distribution.|multi-level latent growth curve||6-month follow up, effect of SUM among those who did not view CT video.|||2.03|-3.16|0.67
72541804|NCT03125915|144613420|SUPERIORITY||Beta|-0.24||||0.83|TWO_SIDED|95.0|-2.39|1.91||A multi-level latent growth curve (LGC) with an intercept and linear slope was specified. The main effects of SUM and CT video were modeled at level 2 in addition to their interaction. Drug use was specified as a binomial distribution.|multi-level latent growth curve||6-month follow up, effect of CT video among those who completed the SUM.|||1.91|-2.39|0.83
72541805|NCT03125915|144613420|SUPERIORITY||Beta|3.13||||0.05|TWO_SIDED|95.0|-0.004|6.25||A multi-level latent growth curve (LGC) with an intercept and linear slope was specified. The main effects of SUM and CT video were modeled at level 2 in addition to their interaction. Drug use was specified as a binomial distribution.|multi-level latent growth curve||6-month follow-up, effects of CT video among those who did not complete SUM.|||6.25|-0.004|0.05
72541806|NCT03125915|144613421|SUPERIORITY||Beta|0.05||||0.9|TWO_SIDED|95.0|-2.3|2.41||A multi-level latent growth curve (LGC) with an intercept and linear slope was specified. The main effects of SUM and CT video were modeled at level 2 in addition to their interaction. Drug use was specified as a binomial distribution.|multi-level latent growth curve||Effect of SUM on the latent intercept factor among those who did not view CT videos|||2.41|-2.30|0.90
72541807|NCT03125915|144613421|SUPERIORITY||Beta|0.26||||0.78|TWO_SIDED|95.0|-2.23|2.75||A multi-level latent growth curve (LGC) with an intercept and linear slope was specified. The main effects of SUM and CT video were modeled at level 2 in addition to their interaction. Drug use was specified as a binomial distribution.|multi-level latent growth curve||Effects of CT video on the latent intercept factor among those who did not view SUM.|||2.75|-2.23|0.78
72627921|NCT01918189|144784036|OTHER|Mixed models (using an unstructured correlation structure) regression over the baseline and 10-week post-baseline follow-up assessments were used to examine change in outcome measures for preliminary efficacy variables. The primary endpoint for the preliminary efficacy analyses is the mean difference in baseline to post-baseline follow-up scores on the measure of mood symptoms at 10 weeks post-baseline.|Mean Difference (Net)|0.05||||0.48|TWO_SIDED|||||a priori threshold for statistical significance is p\<0.05|Regression, Logistic|||||||0.48
72627922|NCT01918189|144784037|OTHER|Mixed models (using an unstructured correlation structure) regression over the baseline and 10-week post-baseline follow-up assessments were used to examine change in outcome measures for preliminary efficacy variables. The primary endpoint for the preliminary efficacy analyses is the mean difference in baseline to post-baseline follow-up scores on the measure of sleep at 10 weeks post-baseline.|Mean Difference (Net)|0.05||||0.18|TWO_SIDED|95.0||||a priori threshold for statistical significance is p\<0.05|Regression, Logistic|||||||0.18
72627923|NCT01918189|144784038|OTHER|Mixed models (using an unstructured correlation structure) regression over the baseline and 10-week post-baseline follow-up assessments were used to examine change in outcome measures for preliminary efficacy variables. The primary endpoint for the preliminary efficacy analyses is the mean difference in baseline to post-baseline follow-up scores on the measure of depression symptoms at 10 weeks post-baseline.|Mean Difference (Final Values)|0.05||||0.03|TWO_SIDED|95.0||||a priori threshold for statistical significance is p\<0.05|Regression, Logistic|||||||0.03
72627924|NCT00518180|144784074|NON_INFERIORITY_OR_EQUIVALENCE|The immunogenicity of MenACWY given concomitantly with HPV and Tdap was considered non inferior to the immunogenicity of MenACWY administered alone, if, for each serogroup, the lower limit of the two-sided 95% confidence interval (CI) for the difference in percentage of subjects with seroresponse at one month after MenACWY vaccination (PGroup I minus PGroup II) was greater than -10%.|Vaccine Group differences (%)|-2.0|||||TWO_SIDED|95.0|-6.0|3.0||||||Immune response to Men A when MenACWY is administered concomitantly with Tdap and HPV, compared with the immune response to MenACWY when administered alone. Method: ANCOVA. Parameter estimate: Vaccine Group Differences.||3|-6|
72627925|NCT00518180|144784074|NON_INFERIORITY_OR_EQUIVALENCE|The immunogenicity of MenACWY given concomitantly with HPV and Tdap was considered non inferior to the immunogenicity of MenACWY administered alone, if, for each serogroup, the lower limit of the two-sided 95% confidence interval (CI) for the difference in percentage of subjects with seroresponse at one month after MenACWY vaccination (PGroup I minus PGroup II) was greater than -10%.|Vaccine Group differences (%)|-1.0|||||TWO_SIDED|95.0|-6.0|3.0||||||Immune response to Men C when MenACWY is administered concomitantly with Tdap and HPV, compared with the immune response to MenACWY when administered alone. Method: ANCOVA. Parameter estimate: Vaccine Group Differences.||3|-6|
72627926|NCT00518180|144784074|NON_INFERIORITY_OR_EQUIVALENCE|The immunogenicity of MenACWY given concomitantly with HPV and Tdap was considered non inferior to the immunogenicity of MenACWY administered alone, if, for each serogroup, the lower limit of the two-sided 95% confidence interval (CI) for the difference in percentage of subjects with seroresponse at one month after MenACWY vaccination (PGroup I minus PGroup II) was greater than -10%.|Vaccine Group differences (%)|-4.0|||||TWO_SIDED|95.0|-9.0|1.0||||||Immune response to Men W when MenACWY is administered concomitantly with Tdap and HPV, compared with the immune response to MenACWY when administered alone. Method: ANCOVA. Parameter estimate: Vaccine Group Differences.||1|-9|
72627927|NCT00518180|144784074|NON_INFERIORITY_OR_EQUIVALENCE|The immunogenicity of MenACWY given concomitantly with HPV and Tdap was considered non inferior to the immunogenicity of MenACWY administered alone, if, for each serogroup, the lower limit of the two-sided 95% confidence interval (CI) for the difference in percentage of subjects with seroresponse at one month after MenACWY vaccination (PGroup I minus PGroup II) was greater than -10%.|Vaccine Group differences (%)|0.0|||||TWO_SIDED|95.0|-4.0|5.0||||||Immune response to Men Y when MenACWY is administered concomitantly with Tdap and HPV, compared with the immune response to MenACWY when administered alone. Method: ANCOVA. Parameter estimate: Vaccine Group Differences.||5|-4|
72369252|NCT00611026|144248561|SUPERIORITY_OR_OTHER|||||||0.0001|TWO_SIDED|||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with terms for country and treatment and ranked baseline value as a covariate.||Treatment difference fesoterodine vs placebo at Week 12.||||0.0001
72627928|NCT00518180|144784074|NON_INFERIORITY_OR_EQUIVALENCE|The immunogenicity of MenACWY given after Tdap was considered non inferior to the immunogenicity of MenACWY administered alone, if, for each serogroup, the lower limit of the two-sided 95% confidence interval (CI) for the difference in percentage of subjects with seroresponse at one month after MenACWY vaccination (PGroup III minus PGroup II) was greater than -10%.|Vaccine Group differences (%)|5.0|||||TWO_SIDED|95.0|1.0|10.0||||||Immune response to Men A when MenACWY is administered 1 month after Tdap, compared with the immune response to MenACWY when administered alone. Method: ANCOVA. Parameter estimate: Vaccine Group Differences.||10|1|
72627929|NCT00518180|144784074|NON_INFERIORITY_OR_EQUIVALENCE|The immunogenicity of MenACWY given after Tdap was considered non inferior to the immunogenicity of MenACWY administered alone, if, for each serogroup, the lower limit of the two-sided 95% confidence interval (CI) for the difference in percentage of subjects with seroresponse at one month after MenACWY vaccination (PGroup III minus PGroup II) was greater than -10%.|Vaccine Group differences (%)|-1.0|||||TWO_SIDED|95.0|-6.0|4.0||||||Immune response to Men C when MenACWY is administered 1 month after Tdap, compared with the immune response to MenACWY when administered alone. Method: ANCOVA. Parameter estimate: Vaccine Group Differences.||4|-6|
72627930|NCT00518180|144784074|NON_INFERIORITY_OR_EQUIVALENCE|The immunogenicity of MenACWY given after Tdap was considered non inferior to the immunogenicity of MenACWY administered alone, if, for each serogroup, the lower limit of the two-sided 95% confidence interval (CI) for the difference in percentage of subjects with seroresponse at one month after MenACWY vaccination (PGroup III minus PGroup II) was greater than -10%.|Vaccine Group differences (%)|-16.0|||||TWO_SIDED|95.0|-21.0|-10.0||||||Immune response to Men W when MenACWY is administered 1 month after Tdap, compared with the immune response to MenACWY when administered alone. Method: ANCOVA. Parameter estimate: Vaccine Group Differences.||-10|-21|
72627931|NCT00518180|144784074|NON_INFERIORITY_OR_EQUIVALENCE|The immunogenicity of MenACWY given after Tdap was considered non inferior to the immunogenicity of MenACWY administered alone, if, for each serogroup, the lower limit of the two-sided 95% confidence interval (CI) for the difference in percentage of subjects with seroresponse at one month after MenACWY vaccination (PGroup III minus PGroup II) was greater than -10%.|Vaccine Group differences (%)|-4.0|||||TWO_SIDED|95.0|-9.0|1.0||||||Immune response to Men Y when MenACWY is administered 1 month after Tdap, compared with the immune response to MenACWY when administered alone. Method: ANCOVA. Parameter estimate: Vaccine Group Differences.||1|-9|
72627932|NCT00518180|144784075|NON_INFERIORITY_OR_EQUIVALENCE|Non inferiority of the immune response to Tdap when administered concomitantly with MenACWY and HPV, compared with the immune response to Tdap when administered alone, was demonstrated for the diphteria and tetanus antigens if the lower limits of the two-sided 95% CIs around the difference in the percentages of subjects with ELISA anti-D toxin ≥ 1.0 IU/mL \[Group I minus Group III\] were greater than -10%.|Vaccine Group differences (%)|2.0|||||TWO_SIDED|95.0|1.0|4.0||||||Non inferiority of the immune response to diphteria antigen, when Tdap is administered concomitantly with MenACWY and HPV, compared with the immune response to Tdap when administered alone. Method: ANCOVA. Parameter estimate: Vaccine Group Differences.||4|1|
72627933|NCT00518180|144784075|NON_INFERIORITY_OR_EQUIVALENCE|Non inferiority of the immune response to Tdap when administered concomitantly with MenACWY and HPV, compared with the immune response to Tdap when administered alone, was demonstrated for the diphteria and tetanus antigens if the lower limits of the two-sided 95% CIs around the difference in the percentages of subjects with ELISA anti-D toxin ≥ 1.0 IU/mL \[Group I minus Group III\] were greater than -10%.|Vaccine Group differences (%)|0.0|||||TWO_SIDED|95.0|-1.0|1.0||||||Non inferiority of the immune response to tetanus antigen, when Tdap is administered concomitantly with MenACWY and HPV, compared with the immune response to Tdap when administered alone. Method: ANCOVA. Parameter estimate: Vaccine Group Differences.||1|-1|
72627934|NCT00518180|144784084|NON_INFERIORITY_OR_EQUIVALENCE|Tdap concomitant with MenACWY a was considered non inferior to Tdap alone if, for PT, FHA and pertactin, the lower limit of the two-sided 95% CI for the ratio of the GMCs (GMC Group I / GMC Group III) at 1 month after vaccination was \> 0.67.|Vaccine Group Ratio|0.8|||||TWO_SIDED|95.0|0.72|0.9||||||Non inferiority of the immune response to Tdap is administered concomitantly with MenACWY and HPV, compared with the immune response to Tdap when administered alone, for PT antigen. Method: ANCOVA. Parameter estimate: Vaccine Group Ratio.||0.9|0.72|
72627935|NCT00518180|144784084|NON_INFERIORITY_OR_EQUIVALENCE|Tdap concomitant with MenACWY a was considered non inferior to Tdap alone if, for PT, FHA and pertactin, the lower limit of the two-sided 95% CI for the ratio of the GMCs (GMC Group I / GMC Group III) at 1 month after vaccination was \> 0.67.|Vaccine Group Ratio|0.68|||||TWO_SIDED|95.0|0.58|0.81||||||Non inferiority of the immune response to Tdap when administered concomitantly with MenACWY and HPV, compared with the immune response to Tdap when administered alone, for PRN antigen. Method: ANCOVA. Parameter estimate: Vaccine Group Ratio.||0.81|0.58|
72627936|NCT00518180|144784084|NON_INFERIORITY_OR_EQUIVALENCE|Tdap concomitant with MenACWY a was considered non inferior to Tdap alone if, for PT, FHA and pertactin, the lower limit of the two-sided 95% CI for the ratio of the GMCs (GMC Group I / GMC Group III) at 1 month after vaccination was \> 0.67.|Vaccine Group Ratio|0.67|||||TWO_SIDED|95.0|0.58|0.76||||||Non inferiority of the immune response to Tdap when administered concomitantly with MenACWY and HPV, compared with the immune response to Tdap when administered alon, for FHA antigen. Method: ANCOVA. Parameter estimate: Vaccine Group Ratio.||0.76|0.58|
72410103|NCT01591681|144328535|SUPERIORITY_OR_OTHER||||||<|0.001||||||The a priori threshold for statistical significance is 0.05.|Repeated measures regression model|Repeated measures regression model was used accounting for correlated data from the same participant and for the overnight measures.||||||<0.001
72627937|NCT03060902|144784087|SUPERIORITY||F|10.16||||0.002|TWO_SIDED||||||ANOVA|||||||.002
72627938|NCT02972996|144784116|OTHER|||||||0.56|||||||ANCOVA|||Values are least-squares means ± SEs (adjusted for the baseline values) from ANCOVA linear mixed model that included covariates of age, baseline (pretreatment values), BMI and weight.||||0.56
72627939|NCT02972996|144784117|OTHER|||||||0.03|||||||ANCOVA|||||||0.03
72576232|NCT04080544|144678785|OTHER|Null-hypothesis significance testing|Slope|-0.27|STANDARD_ERROR_OF_MEAN|0.23||0.235|TWO_SIDED|95.0|-0.73|0.18||A priori threshold was two-sided 0.05. No adjustment for multiple comparisons.|Regression, Linear|Adjusted for age, sex, and years of education.||Regression testing the relationship between temporal tau SUVR to parahippocampal gyrus cortical thickness.||0.18|-0.73|.235
72576233|NCT04080544|144678785|OTHER|Null-hypothesis significance testing|Slope|0.19|STANDARD_ERROR_OF_MEAN|0.41||0.639|TWO_SIDED|95.0|-0.63|1.01||A priori threshold was two-sided 0.05. No adjustment for multiple comparisons.|Regression, Linear|Adjusted for age, sex, and years of education.||Regression testing the relationship between temporal tau SUVR to entorhinal gyrus cortical thickness.||1.01|-0.63|.639
72576234|NCT04080544|144678785|OTHER|Null-hypothesis significance test|Slope|0.19|STANDARD_ERROR_OF_MEAN|0.16||0.252|TWO_SIDED|95.0|-0.13|0.5||A priori threshold was two-sided 0.05. No adjustment for multiple comparisons.|Regression, Linear|Adjusted for age, sex, and years of education.||Regression testing the relationship of temporal tau SUVR to fusiform gyrus cortical thickness.||0.50|-0.13|.252
72576235|NCT04080544|144678786|OTHER|Null-hypothesis significance test|Slope|-233.74|STANDARD_ERROR_OF_MEAN|469.31||0.619|TWO_SIDED|95.0|-1163.28|695.79||A priori threshold was two-sided 0.05. No adjustment for multiple comparisons.|Regression, Linear|Adjusted for age, sex, and years of education.||Regression testing the relationship of temporal tau SUVR to hippocampal volume.||695.79|-1163.28|.619
72576236|NCT04080544|144678787|OTHER|Null-hypothesis significance test|Slope|9260.01|STANDARD_ERROR_OF_MEAN|3836.92||0.017|TWO_SIDED|95.0|1660.52|16859.51||A priori threshold was two-sided 0.05. No adjustment for multiple comparisons.|Regression, Linear|Adjusted for age, sex, and years of education.||Regression testing the relationship of temporal tau SUVR to volume of white matter hypointensities.||16859.51|1660.52|.017
72576237|NCT04080544|144678788|OTHER|Null-hypothesis significance test|Slope|0.29|STANDARD_ERROR_OF_MEAN|0.35||0.411|TWO_SIDED|95.0|-0.41|0.99||A priori threshold was two-sided 0.05. No adjustment for multiple comparisons.|Regression, Linear|Adjusted for age, sex, and years of education.||Regression testing the relationship of temporal tau SUVR to activation of inferior frontal gyrus (beta) on the semantic judgment fMRI task.||0.99|-0.41|.411
72576238|NCT04080544|144678788|OTHER|Null-hypothesis significance test|Slope|0.24|STANDARD_ERROR_OF_MEAN|0.29||0.412|TWO_SIDED|95.0|-0.34|0.81||A priori threshold was two-sided 0.05. No adjustment for multiple comparisons.|Regression, Linear|Adjusted for age, sex, and years of education.||Regression testing the relationship of temporal tau SUVR to middle temporal gyrus activation (beta) on the semantic judgment fMRI task.||0.81|-0.34|.412
72576239|NCT04080544|144678788|OTHER|Null-hypothesis significance test|Slope|0.31|STANDARD_ERROR_OF_MEAN|0.4||0.438|TWO_SIDED|95.0|-0.48|1.09||A priori threshold was two-sided 0.05. No adjustment for multiple comparisons.|Regression, Linear|Adjusted for age, sex, and years of education.||Regression testing the relationship of temporal tau SUVR to precuneus gyrus activation (beta) on the semantic judgment fMRI task.||1.09|-0.48|.438
72576240|NCT04080544|144678789|OTHER|Null-hypothesis significance test|Slope|-1.13|STANDARD_ERROR_OF_MEAN|0.5||0.026|TWO_SIDED|95.0|-2.12|-0.14||A priori threshold was two-sided 0.05. No adjustment for multiple comparisons.|Regression, Linear|Adjusted for age, sex, and years of education.||Regression testing the relationship of temporal tau SUVR to resting-state system segregation.||-0.14|-2.12|.026
72576241|NCT00197496|144678796|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-26.3|||<|0.05|TWO_SIDED|95.0|-72.1|19.6|||Regression, Linear|||||19.6|-72.1|<0.05
72576242|NCT00197496|144678799|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.8||||0.4|TWO_SIDED|95.0|-3.6|9.2|||Regression, Linear|||||9.2|-3.6|0.40
72576243|NCT01908907|144678930|SUPERIORITY_OR_OTHER||Median Difference (Net)|13.5|STANDARD_ERROR_OF_MEAN|6.5||0.07|TWO_SIDED|95.0|0.2|28.7|||Regression, Linear|Outcome was transformed using a natural logarithm transformation. Models included gestational age group since the randomization was blocked.|Since analyzed on the log scale, estimates provide are % change rather than absolute change between group.|All analyses used the intent-to-treat study population. A linear mixed model was used to assess differences in time to full feeds, days on study drug, and gestational age at discharge. These models included a random effect for multiples, which was maintained in the model after testing. Fixed effects included treatment and GA group for time to full feeds and days on study drug and treatment effect for gestational age at discharge.||28.7|0.2|0.07
72576244|NCT01908907|144678931|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.016|STANDARD_ERROR_OF_MEAN|0.008||0.048|TWO_SIDED||||||Regression, Linear|This is a complex regression model including linear and quadratic growth and interactions as specified above.||Linear mixed models were used to explore growth over time (weight, length and head circumference). These models included a random effect for intercepts and slopes to account for subject specific growth over time as well as a random effect for possible correlation between twins and triplets present in the data set. Fixed effects included both a linear and quadratic time effect, GA at birth, treatment group, full feeds (yes/no), and interactions. Non-significant interactions were eliminated.||||0.048
72576245|NCT00761657|144678939|OTHER|||||||0.2073||||||Threshold for significance at 0.05 level.|t-test, 2 sided|||P-value is from inter-group 2-sample t-tests comparing roxadustat change from baseline with placebo change from baseline.||||0.2073
72576246|NCT00761657|144678939|OTHER|||||||0.0046||||||Threshold for significance at 0.05 level.|t-test, 2 sided|||P-value is from inter-group 2-sample t-tests comparing roxadustat change from baseline with placebo change from baseline.||||0.0046
72410104|NCT01591681|144328536|SUPERIORITY_OR_OTHER|||||||0.98||||||The a priori threshold for statistical significance is 0.05.|Repeated measures regression model|Repeated measures regression model was used accounting for correlated data from the same participant and for the overnight measures.||||||0.98
72576247|NCT00761657|144678939|OTHER|||||||0.086||||||Threshold for significance at 0.05 level.|t-test, 2 sided|||P-value is from inter-group 2-sample t-tests comparing roxadustat change from baseline with placebo change from baseline.||||0.0860
72576248|NCT00761657|144678939|OTHER|||||||0.4005||||||Threshold for significance at 0.05 level.|t-test, 2 sided|||P-value is from inter-group 2-sample t-tests comparing roxadustat change from baseline with placebo change from baseline.||||0.4005
72576249|NCT00761657|144678939|OTHER||||||<|0.0001||||||Threshold for significance at 0.05 level.|t-test, 2 sided|||P-value is presented for Day 26-29 timepoint. P-value is from inter-group 2-sample t-tests comparing roxadustat change from baseline with placebo change from baseline.||||<0.0001
72576250|NCT00761657|144678939|OTHER||||||<|0.0001||||||Threshold for significance at 0.05 level.|t-test, 2 sided|||P-value is from inter-group 2-sample t-tests comparing roxadustat change from baseline with placebo change from baseline.||||<0.0001
72576251|NCT00761657|144678939|OTHER||||||<|0.0001||||||Threshold for significance at 0.05 level.|t-test, 2 sided|||P-value is from inter-group 2-sample t-tests comparing roxadustat change from baseline with placebo change from baseline.||||<0.0001
72576252|NCT00761657|144678939|OTHER||||||<|0.0001|||||||t-test, 2 sided|Threshold for significance at 0.05 level.||P-value is from inter-group 2-sample t-tests comparing roxadustat change from baseline with placebo change from baseline.||||<0.0001
72576253|NCT00761657|144678940|OTHER|||||||0.0507||||||Threshold for significance at 0.05 level.|t-test, 2 sided|||P-value is from inter-group 2-sample t-tests comparing roxadustat change from baseline with placebo change from baseline.||||0.0507
72576254|NCT00761657|144678940|OTHER|||||||0.4502||||||Threshold for significance at 0.05 level.|t-test, 2 sided|||P-value is from inter-group 2-sample t-tests comparing roxadustat change from baseline with placebo change from baseline.||||0.4502
72576255|NCT00761657|144678940|OTHER|Threshold for significance at 0.05 level.||||||0.1603|||||||t-test, 2 sided|||P-value is from inter-group 2-sample t-tests comparing roxadustat change from baseline with placebo change from baseline.||||0.1603
72576256|NCT00761657|144678940|OTHER|||||||0.9816||||||Threshold for significance at 0.05 level.|t-test, 2 sided|||P-value is from inter-group 2-sample t-tests comparing roxadustat change from baseline with placebo change from baseline.||||0.9816
72576257|NCT00761657|144678940|OTHER|||||||0.0139||||||Threshold for significance at 0.05 level.|t-test, 2 sided|||P-value is from inter-group 2-sample t-tests comparing roxadustat change from baseline with placebo change from baseline.||||0.0139
72576258|NCT00761657|144678940|OTHER||||||<|0.0001||||||Threshold for significance at 0.05 level.|t-test, 2 sided|||P-value is from inter-group 2-sample t-tests comparing roxadustat change from baseline with placebo change from baseline.||||<0.0001
72576259|NCT00761657|144678940|OTHER|||||||0.0001||||||Threshold for significance at 0.05 level.|t-test, 2 sided|||P-value is from inter-group 2-sample t-tests comparing roxadustat change from baseline with placebo change from baseline.||||0.0001
72576260|NCT00761657|144678940|OTHER||||||<|0.0001||||||Threshold for significance at 0.05 level.|t-test, 2 sided|||P-value is from inter-group 2-sample t-tests comparing roxadustat change from baseline with placebo change from baseline.||||<0.0001
72576261|NCT02500043|144678959|OTHER||Hazard Ratio (HR)|0.6917||||0.0003|TWO_SIDED|95.0|0.5597|0.8548||One-sided P-Value.|Log Rank|||TAS-102+BSC and Placebo+BSC were compared using the stratified log-rank test using the 3 randomization stratification factors (region, ECOG performance status, and prior treatment with ramucirumab). The hazard ratio was estimated using a stratified Cox's proportional hazard (CPH) model and survival was summarized using Kaplan Meier estimates.||0.8548|0.5597|0.0003
72576262|NCT02500043|144678960|OTHER||Hazard Ratio (HR)|0.5723|||||TWO_SIDED|95.0|0.4674|0.7008||||||TAS-102+BSC and Placebo+BSC were compared using the stratified log-rank test using the 3 randomization stratification factors (region, ECOG performance status, and prior treatment with ramucirumab). The hazard ratio was estimated using a stratified CPH model and survival was summarized using Kaplan Meier estimates.||0.7008|0.4674|
72576263|NCT03151408|144678967|SUPERIORITY|||||||0.8275||||||P-value stratified by cytogenetic risk factor and ECOG performance status|Log Rank|||||||0.8275
72576264|NCT03151408|144678968|OTHER|||||||0.1244|||||||Cochran-Mantel-Haenszel|||||||0.1244
72576265|NCT03151408|144678969|OTHER|||||||0.143|||||||Cochran-Mantel-Haenszel|||||||0.1430
72576266|NCT03151408|144678970|SUPERIORITY|||||||0.9977|||||||Cochran-Mantel-Haenszel|||||||0.9977
72576267|NCT03151408|144678971|OTHER|||||||0.9959|||||||Cochran-Mantel-Haenszel|||||||0.9959
72576268|NCT03151408|144678972|OTHER|||||||0.3502|||||||Cochran-Mantel-Haenszel|||||||0.3502
72576269|NCT03151408|144678973|OTHER|||||||0.0502|||||||Log Rank|||||||0.0502
72576270|NCT03151408|144678975|OTHER|||||||0.4656|||||||Log Rank|||||||0.4656
72576271|NCT03151408|144678976|OTHER|||||||0.7063|||||||Log Rank|||||||0.7063
72576272|NCT03151408|144678977|OTHER|||||||0.0592|||||||Log Rank|||||||0.0592
72576273|NCT03151408|144678978|OTHER|||||||0.3835|||||||Log Rank|||||||0.3835
72576274|NCT03151408|144678979|OTHER|||||||0.7099|||||||Cochran-Mantel-Haenszel|||||||0.7099
72576817|NCT00261443|144680655|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.35||||0.015|TWO_SIDED|95.0|-0.62|-0.07||Baseline: ANOVA model, controlling for treatment, mood stabilizer, and index mood episode. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 52 Comparison||-0.07|-0.62|0.015
72576818|NCT00261443|144680657|SUPERIORITY_OR_OTHER_LEGACY||Difference|0.04||||0.588|TWO_SIDED|95.0|-0.09|0.16||Baseline: ANOVA model, controlling for treatment, mood stabilizer, and index mood episode. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Baseline Comparison||0.16|-0.09|0.588
72576819|NCT00261443|144680657|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.01||||0.922|TWO_SIDED|95.0|-0.18|0.16||Baseline: ANOVA model, controlling for treatment, mood stabilizer, and index mood episode. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 4 Comparison||0.16|-0.18|0.922
72576820|NCT00261443|144680657|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.11||||0.266|TWO_SIDED|95.0|-0.3|0.08||Baseline: ANOVA model, controlling for treatment, mood stabilizer, and index mood episode. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 8 Comparison||0.08|-0.30|0.266
72576821|NCT00261443|144680657|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.14||||0.159|TWO_SIDED|95.0|-0.34|0.06||Baseline: ANOVA model, controlling for treatment, mood stabilizer, and index mood episode. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 12 Comparison||0.06|-0.34|0.159
72369253|NCT00611026|144248561|SUPERIORITY_OR_OTHER|||||||0.0805|TWO_SIDED|||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with terms for country and treatment and ranked baseline value as a covariate.||Treatment difference Tolterodine ER vs placebo at Week 12.||||0.0805
72541808|NCT03125915|144613421|SUPERIORITY||Beta|-1.18||||0.53|TWO_SIDED|95.0|-4.86|2.51||A multi-level latent growth curve (LGC) with an intercept and linear slope was specified. The main effects of SUM and CT video were modeled at level 2 in addition to their interaction. Drug use was specified as a binomial distribution.|multi-level latent growth curve||Effects of the interaction between SUM and CT video on the latent intercept.|||2.51|-4.86|0.53
72576275|NCT01235195|144678980|SUPERIORITY_OR_OTHER_LEGACY||Ratio (%) of adjusted means|104.86|||||TWO_SIDED|90.0|100.12|109.83|||||Reference treatment=Sertraline hydrochloride 50 mg hard gelatin capsule. Test treatment=sertraline hydrochloride 50 mg film-coated tablet.|Natural log-transformed AUC (0-72) analyzed using a mixed effect model with sequence, period, treatment as fixed effects; subject within sequence as a random effect. Estimates of adjusted mean differences (Test minus Reference) and corresponding 90% confidence intervals (CIs) were obtained from the model. Adjusted mean differences and 90% CIs for differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test divided by Reference) and 90% CIs for the ratios.||109.83|100.12|
72576276|NCT01235195|144678981|SUPERIORITY_OR_OTHER_LEGACY||Ratio (%) of adjusted means|105.34|||||TWO_SIDED|90.0|98.46|112.69|||||Reference treatment=Sertraline hydrochloride 50 mg hard gelatin capsule. Test treatment=sertraline hydrochloride 50 mg film-coated tablet.|Natural log-transformed Cmax analyzed using a mixed effect model with sequence, period, treatment as fixed effects; subject within sequence as a random effect. Estimates of adjusted mean differences (Test minus Reference) and corresponding 90% CIs were obtained from the model. Adjusted mean differences and 90% CIs for differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test divided by Reference) and 90% CIs for the ratios.||112.69|98.46|
72576277|NCT01235195|144678983|SUPERIORITY_OR_OTHER_LEGACY||Ratio (%) of adjusted means|106.1|||||TWO_SIDED|90.0|100.16|112.39|||||Reference treatment=Sertraline hydrochloride 50 mg hard gelatin capsule. Test treatment=sertraline hydrochloride 50 mg film-coated tablet.|Natural log-transformed AUC (0-∞) analyzed using a mixed effect model with sequence, period, treatment as fixed effects; subject within sequence as a random effect. Estimates of adjusted mean differences (Test minus Reference) and corresponding 90% CIs were obtained from the model. Adjusted mean differences and 90% CIs for differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test divided by Reference) and 90% CIs for the ratios.||112.39|100.16|
72576278|NCT01473524|144678986|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) General Association test stratified by randomization strata factor.||H0: The response rates are equal between placebo and 10 mg OCA. H1: The response rates are different between placebo and 10 mg OCA.||||<0.0001
72541809|NCT03125915|144613421|SUPERIORITY||Beta|1.83||||0.14|TWO_SIDED|95.0|-0.62|4.29||A multi-level latent growth curve (LGC) with an intercept and linear slope was specified. The main effects of SUM and CT video were modeled at level 2 in addition to their interaction. Drug use was specified as a binomial distribution.|multi-level latent growth curve||Effect of SUM on the latent slope factor among those who did not view CT Videos.|||4.29|-0.62|0.14
72541810|NCT03125915|144613421|SUPERIORITY||Beta|0.35||||0.76|TWO_SIDED|95.0|-2.02|2.72||A multi-level latent growth curve (LGC) with an intercept and linear slope was specified. The main effects of SUM and CT video were modeled at level 2 in addition to their interaction. Drug use was specified as a binomial distribution.|multi-level latent growth curve||Effects of CT Video on latent slope factor among those who did not complete the SUM.|||2.72|-2.02|0.76
72541811|NCT03125915|144613421|SUPERIORITY||Beta|-1.28||||0.45|TWO_SIDED|95.0|-4.62|2.06||A multi-level latent growth curve (LGC) with an intercept and linear slope was specified. The main effects of SUM and CT video were modeled at level 2 in addition to their interaction. Drug use was specified as a binomial distribution.|multi-level latent growth curve||Effects of the interaction between SUM and CT videos in the prediction of the latent slope factor.|||2.06|-4.62|0.45
72541812|NCT03125915|144613422|SUPERIORITY||Beta|-0.75||||0.02|TWO_SIDED|95.0|-1.39|-0.11||A multi-level latent growth curve (LGC) with an intercept and linear slope was specified. The main effects of SUM and CT video were modeled at level 2 in addition to their interaction. Drug use was specified as a binomial distribution.|multi-level latent growth curve||1-month follow-up, effect of SUM among those who viewed CT videos.|||-0.11|-1.39|0.02
72541813|NCT03125915|144613422|SUPERIORITY||Beta|-0.49||||0.1|TWO_SIDED|95.0|-1.07|0.09||A multi-level latent growth curve (LGC) with an intercept and linear slope was specified. The main effects of SUM and CT video were modeled at level 2 in addition to their interaction. Drug use was specified as a binomial distribution.|multi-level latent growth curve||1-month follow-up, effect of SUM among those who did not view CT videos.|||0.09|-1.07|0.10
72541814|NCT03125915|144613422|SUPERIORITY||Beta|-0.15||||0.63|TWO_SIDED|95.0|-0.77|0.47||A multi-level latent growth curve (LGC) with an intercept and linear slope was specified. The main effects of SUM and CT video were modeled at level 2 in addition to their interaction. Drug use was specified as a binomial distribution.|multi-level latent growth curve||1-month follow-up, effects of CT video among those who completed SUM.|||0.47|-0.77|0.63
72541815|NCT03125915|144613422|SUPERIORITY||Beta|-0.41||||0.19|TWO_SIDED|95.0|-1.01|0.2||A multi-level latent growth curve (LGC) with an intercept and linear slope was specified. The main effects of SUM and CT video were modeled at level 2 in addition to their interaction. Drug use was specified as a binomial distribution.|multi-level latent growth curve||1-month follow-up, effects of CT video among those who did not complete SUM.|||0.20|-1.01|0.19
72369254|NCT00611026|144248561|SUPERIORITY_OR_OTHER|||||||0.0093|TWO_SIDED|||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with terms for country and treatment and ranked baseline value as a covariate.||Treatment difference Tolterodine ER vs Fesoterodine at Week 12.||||0.0093
72627940|NCT03710889|144784135|OTHER|Within treatment paired t-tests were used to compare the differences in dynamic indices between Baseline and Month 3 using the Bone-Biopsy Population. If the normality assumption is not satisfied at the 0.01 significance level and visual inspection of the data deems it necessary, Wilcoxon signed-rank test is used. No adjustments for multiplicity were made. A 2-sided p-value \<0.05 was considered statistically significant.|||||<|0.0001|||||||Paired t-test, 2 sided|||||||<0.0001
72576279|NCT01473524|144678988|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) General Association test stratified by randomization strata factor.||H0: The response rates are equal between placebo and 10 mg OCA. H1: The response rates are different between placebo and 10 mg OCA.||||<0.0001
72576280|NCT01473524|144678989|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) General Association test stratified by randomization strata factor.||H0: The response rates are equal between placebo and 5-10 mg OCA. H1: The response rates are different between placebo and 5-10 mg OCA.||||<0.0001
72576281|NCT01473524|144678990|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) General Association test stratified by randomization strata factor.||H0: The response rates are equal between placebo and 5-10 mg OCA. H1: The response rates are different between placebo and 5-10 mg OCA.||||<0.0001
72576282|NCT01473524|144678991|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||ANCOVA|ANCOVA model with baseline value as a covariate and fixed effects for treatment and randomization strata factor.||||||<0.0001
72576283|NCT01473524|144678991|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||ANCOVA|ANCOVA model with baseline value as a covariate and fixed effects for treatment and randomization strata factor.||||||<0.0001
72576284|NCT01473524|144678992|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0004|||||||ANCOVA|ANCOVA model with baseline value as a covariate and fixed effects for treatment and randomization strata factor.||||||0.0004
72576285|NCT01473524|144678992|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||ANCOVA|ANCOVA model with baseline value as a covariate and fixed effects for treatment and randomization strata factor.||||||<0.0001
72576286|NCT01473524|144678993|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||ANCOVA|ANCOVA model with baseline value as a covariate and fixed effects for treatment and randomization strata factor.||||||<0.0001
72576287|NCT01473524|144678993|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANCOVA|ANCOVA model with baseline value as a covariate and fixed effects for treatment and randomization strata factor.||||||<0.0001
72576288|NCT01473524|144678994|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||ANCOVA|ANCOVA model with baseline value as a covariate and fixed effects for treatment and randomization strata factor.||||||<0.0001
72576289|NCT01473524|144678994|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||ANCOVA|ANCOVA model with baseline value as a covariate and fixed effects for treatment and randomization strata factor.||||||<0.0001
72627941|NCT04881760|144784142|SUPERIORITY||LS Mean difference (Final Values)|-5.64|||<|0.001|TWO_SIDED|95.0|-7.34|-3.94|||Mixed Models Analysis|||||-3.94|-7.34|<0.001
72410105|NCT01591681|144328537|SUPERIORITY_OR_OTHER|||||||0.93||||||The a priori threshold for statistical significance is 0.05.|Repeated measures regression model|Repeated measures regression model was used accounting for correlated data from the same participant and for the overnight measures.||||||0.93
72627942|NCT04881760|144784142|SUPERIORITY||LS Mean difference (Final Values)|-10.45|||<|0.001|TWO_SIDED|95.0|-12.21|-8.7|||Mixed Models Analysis|||||-8.70|-12.21|<0.001
72410106|NCT01649856|144328543|SUPERIORITY_OR_OTHER||Difference in Response Rates|8.2||||0.076||95.0|-1.1|17.5|||Chi-squared|||||17.5|-1.1|0.076
72410107|NCT04551105|144328596|SUPERIORITY||different in area under the LROC curve|0.0374|||<|0.05|TWO_SIDED|95.0|0.019|0.0557|||OR-DBM model|||||0.0557|0.0190|<0.05
72410108|NCT04551105|144328597|SUPERIORITY||Mean Difference (Net)|12.78|||<|0.05|TWO_SIDED||||||t-test, 2 sided|||||||<0.05
72576290|NCT01473524|144678995|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0003|TWO_SIDED||||||ANCOVA|ANCOVA model with baseline value as a covariate and fixed effects for treatment and randomization strata factor.||||||0.0003
72576291|NCT01473524|144678995|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||ANCOVA|ANCOVA model with baseline value as a covariate and fixed effects for treatment and randomization strata factor||||||<0.0001
72576292|NCT01473524|144678996|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||ANCOVA|ANCOVA model with baseline value as a covariate and fixed effects for treatment and randomization strata factor.||||||<0.0001
72576293|NCT01473524|144678996|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||ANCOVA|ANCOVA model with baseline value as a covariate and fixed effects for treatment and randomization strata factor.||||||<0.0001
72576294|NCT02383810|144678999|SUPERIORITY|The overall hypothesis system was represented by the following pool of partial hypothesis systems: Hok: πGi = πGj i = 1 to 3, and j = 2 to 4, and k = 1 to 6, and i ≠ j HAk: πGi ≠πGj i = 1 to 3, and j = 2 to 4, and k = 1 to 6, and i ≠ j where πG is the probability of absence of Grade ≥2 CID for the Group. Each Ho involved 2 groups.|||||<|0.1||||||Overall alpha level 0.10 was maintained by correction for multiplicity according to Hommel's procedure.|Chi-squared|||Overall null hypothesis: All elsiglutide dose groups had equal proportion of subjects with max Grade≥2 diarrhea and this was equal to the one in the placebo group. This includes 6 individual hypotheses (i.e., 3 to compare each dose group vs. placebo and 3 to compare dose groups vs. each other). Raw p-values from Chi square tests were corrected for multiplicity according to the Hommel's procedure. Each of 6 hypotheses was then evaluated based on corrected p-value at alpha 0.10 (two-sided).||||<0.1
72627943|NCT04881760|144784142|SUPERIORITY||LS Mean difference (Final Values)|-12.25|||<|0.001|TWO_SIDED|95.0|-14.42|-10.08|||Mixed Models Analysis|||||-10.08|-14.42|<0.001
72627944|NCT04881760|144784142|SUPERIORITY||LS Mean difference (Final Values)|-15.1|||<|0.001|TWO_SIDED|95.0|-16.9|-13.3|||Mixed Models Analysis|||||-13.30|-16.90|<0.001
72627945|NCT04881760|144784142|SUPERIORITY||LS Mean difference (Final Values)|-16.72|||<|0.001|TWO_SIDED|95.0|-18.86|-14.58|||Mixed Models Analysis|||||-14.58|-18.86|<0.001
72627946|NCT04881760|144784142|SUPERIORITY||LS Mean difference (Final Values)|-15.85|||<|0.001|TWO_SIDED|95.0|-17.57|-14.13|||Mixed Models Analysis|||||-14.13|-17.57|<0.001
72627947|NCT04881760|144784143|SUPERIORITY||LS Mean difference (Final Values)|-6.57|||<|0.001|TWO_SIDED|95.0|-8.94|-4.2|||Mixed Models Analysis|||||-4.20|-8.94|<0.001
72627948|NCT04881760|144784143|SUPERIORITY||LS Mean difference (Final Values)|-14.21|||<|0.001|TWO_SIDED|95.0|-17.64|-10.78|||Mixed Models Analysis|||||-10.78|-17.64|<0.001
72541816|NCT03125915|144613422|SUPERIORITY||Beta|-0.64||||0.01|TWO_SIDED|95.0|-1.13|-0.15||A multi-level latent growth curve (LGC) with an intercept and linear slope was specified. The main effects of SUM and CT video were modeled at level 2 in addition to their interaction. Drug use was specified as a binomial distribution.|multi-level latent growth curve||3-month follow-up, effect of SUM among those who completed the CT video.|||-0.15|-1.13|0.01
72541817|NCT03125915|144613422|SUPERIORITY||Beta|-0.49||||0.12|TWO_SIDED|95.0|-1.11|0.12||A multi-level latent growth curve (LGC) with an intercept and linear slope was specified. The main effects of SUM and CT video were modeled at level 2 in addition to their interaction. Drug use was specified as a binomial distribution.|multi-level latent growth curve||3-month follow-up, effects of SUM among those who did not complete CT video.|||0.12|-1.11|0.12
72541818|NCT03125915|144613422|SUPERIORITY||Beta|-0.34||||0.23|TWO_SIDED|95.0|-0.89|0.21||A multi-level latent growth curve (LGC) with an intercept and linear slope was specified. The main effects of SUM and CT video were modeled at level 2 in addition to their interaction. Drug use was specified as a binomial distribution.|multi-level latent growth curve||3-month follow-up, effects of CT video among those who completed SUM.|||0.21|-0.89|0.23
72541819|NCT03125915|144613422|SUPERIORITY||Beta|-0.19||||0.51|TWO_SIDED|95.0|-0.76|0.38||A multi-level latent growth curve (LGC) with an intercept and linear slope was specified. The main effects of SUM and CT video were modeled at level 2 in addition to their interaction. Drug use was specified as a binomial distribution.|multi-level latent growth curve||3-month follow-up, effect of CT video among those who did not complete SUM.|||0.38|-0.76|0.51
72627949|NCT04881760|144784143|SUPERIORITY||LS Mean difference (Final Values)|-15.72|||<|0.001|TWO_SIDED|95.0|-19.05|-12.4|||Mixed Models Analysis|||||-12.40|-19.05|<0.001
72627950|NCT04881760|144784143|SUPERIORITY||LS Mean difference (Final Values)|-19.62|||<|0.001|TWO_SIDED|95.0|-22.73|-16.51|||Mixed Models Analysis|||||-16.51|-22.73|<0.001
72627951|NCT04881760|144784143|SUPERIORITY||LS Mean difference (Final Values)|-21.78|||<|0.001|TWO_SIDED|95.0|-25.05|-18.51|||Mixed Models Analysis|||||-18.51|-25.05|<0.001
72627952|NCT04881760|144784143|SUPERIORITY||LS Mean difference (Final Values)|-22.11|||<|0.001|TWO_SIDED|95.0|-24.92|-19.31|||Mixed Models Analysis|||||-19.31|-24.92|<0.001
72627953|NCT04881760|144784144|SUPERIORITY||Risk Difference (RD)|33.0|||<|0.001|TWO_SIDED|95.0|17.0|49.0|||Regression, Logistic|||||49|17|<0.001
72627954|NCT04881760|144784144|SUPERIORITY||Risk Difference (RD)|61.0|||<|0.001|TWO_SIDED|95.0|45.0|77.0|||Regression, Logistic|||||77|45|<0.001
72410109|NCT04551105|144328598|SUPERIORITY||different in sensitivity|-0.0013|||<|0.05|TWO_SIDED|95.0|-0.2307|0.2281|||McNemar|||||0.2281|-0.2307|<0.05
72410110|NCT04551105|144328598|SUPERIORITY||different in specificity|0.1065|||<|0.05|TWO_SIDED|95.0|0.0008|0.2122|||McNemar|||||0.2122|0.0008|<0.05
72541820|NCT03125915|144613422|SUPERIORITY||Beta|-0.79||||0.003|TWO_SIDED|95.0|-1.32|-0.27||A multi-level latent growth curve (LGC) with an intercept and linear slope was specified. The main effects of SUM and CT video were modeled at level 2 in addition to their interaction. Drug use was specified as a binomial distribution.|multi-level latent growth curve||6-month follow-up, effects of SUM among those who viewed CT videos.|||-0.27|-1.32|0.003
72627955|NCT04881760|144784144|SUPERIORITY||Risk Difference (RD)|68.0|||<|0.001|TWO_SIDED|95.0|54.0|81.0|||Regression, Logistic|||||81|54|<0.001
72627956|NCT04881760|144784144|SUPERIORITY||Risk Difference (RD)|74.0|||<|0.001|TWO_SIDED|95.0|63.0|85.0|||Regression, Logistic|||||85|63|<0.001
72627957|NCT04881760|144784144|SUPERIORITY||Risk Difference (RD)|74.0|||<|0.001|TWO_SIDED|95.0|63.0|85.0|||Regression, Logistic|||||85|63|<0.001
72410111|NCT04551105|144328598|SUPERIORITY||different in PPV|-0.086|||<|0.05|TWO_SIDED|95.0|-0.1824|0.0104|||McNemar|||||0.0104|-0.1824|<0.05
72410112|NCT04551105|144328598|SUPERIORITY||different in NPV|0.086|||<|0.05|TWO_SIDED|95.0|-0.0104|0.1824|||McNemar|||||0.1824|-0.0104|<0.05
72627958|NCT04881760|144784144|SUPERIORITY||Risk Difference (RD)|71.0|||<|0.001|TWO_SIDED|95.0|59.0|82.0|||Regression, Logistic|||||82|59|<0.001
72627959|NCT04881760|144784145|SUPERIORITY||Risk Difference (RD)|37.0|||<|0.001|TWO_SIDED|95.0|20.0|54.0|||Regression, Logistic|||||54|20|<0.001
72627960|NCT04881760|144784145|SUPERIORITY||Risk Difference (RD)|60.0|||<|0.001|TWO_SIDED|95.0|44.0|76.0|||Regression, Logistic|||||76|44|<0.001
72627961|NCT04881760|144784145|SUPERIORITY||Risk Difference (RD)|70.0|||<|0.001|TWO_SIDED|95.0|57.0|83.0|||Regression, Logistic|||||83|57|<0.001
72627962|NCT04881760|144784145|SUPERIORITY||Risk Difference (RD)|73.0|||<|0.001|TWO_SIDED|95.0|62.0|84.0|||Regression, Logistic|||||84|62|<0.001
72627963|NCT04881760|144784145|SUPERIORITY||Risk Difference (RD)|73.0|||<|0.001|TWO_SIDED|95.0|62.0|84.0|||Regression, Logistic|||||84|62|<0.001
72627964|NCT04881760|144784145|SUPERIORITY||Risk Difference (RD)|73.0|||<|0.001|TWO_SIDED|95.0|67.0|84.0|||Regression, Logistic|||||84|67|<0.001
72627965|NCT04881760|144784146|SUPERIORITY||Risk Difference (RD)|22.0|||<|0.001|TWO_SIDED|95.0|11.0|33.0|||Regression, Logistic|||||33|11|<0.001
72627966|NCT04881760|144784146|SUPERIORITY||Risk Difference (RD)|56.0|||<|0.001|TWO_SIDED|95.0|38.0|73.0|||Regression, Logistic|||||73|38|<0.001
72627967|NCT04881760|144784146|SUPERIORITY||Risk Difference (RD)|69.0|||<|0.001|TWO_SIDED|95.0|53.0|85.0|||Regression, Logistic|||||85|53|<0.001
72627968|NCT04881760|144784146|SUPERIORITY||Risk Difference (RD)|80.0|||<|0.001|TWO_SIDED|95.0|66.0|93.0|||Regression, Logistic|||||93|66|<0.001
72627969|NCT04881760|144784146|SUPERIORITY||Risk Difference (RD)|91.0|||<|0.001|TWO_SIDED|95.0|83.0|100.0|||Regression, Logistic|||||100|83|<0.001
72627970|NCT04881760|144784146|SUPERIORITY||Risk Difference (RD)|87.0|||<|0.001|TWO_SIDED|95.0|78.0|96.0|||Regression, Logistic|||||96|78|<0.001
72627971|NCT04881760|144784147|SUPERIORITY||Risk Difference (RD)|18.0||||0.008|TWO_SIDED|95.0|5.0|31.0|||Regression, Logistic|||||31|5|0.008
72627972|NCT04881760|144784147|SUPERIORITY||Risk Difference (RD)|64.0|||<|0.001|TWO_SIDED|95.0|48.0|81.0|||Regression, Logistic|||||81|48|<0.001
72627973|NCT04881760|144784147|SUPERIORITY||Risk Difference (RD)|67.0|||<|0.001|TWO_SIDED|95.0|51.0|84.0|||Regression, Logistic|||||84|51|<0.001
72576295|NCT00926783|144679045|SUPERIORITY_OR_OTHER|||||||0.048||||||The p-value was based on Fisher's exact test. There were no adjustments for multiple comparisons.|Fisher Exact|||The null hypothesis is that rates of free from atrial arrhythmia for the two arms, Targeted and Generalized, are the same. The alternative hypothesis is that the rates are not the same. Due to the lack of literature data comparing these endpoints between two randomization groups, the sample size is not statistically powered to support statistical inferences.||||0.048
72576296|NCT00926783|144679046|SUPERIORITY_OR_OTHER|||||||0.002|||||||t-test, 2 sided|||The null hypothesis is that the total RF delivery times for both arms are equal. The alternative hypothesis is that the total RF delivery times are not equal. Due to the lack of literature data comparing these endpoints between two randomization groups, the sample size is not statistically powered to support statistical inferences.||||0.002
72576297|NCT02549027|144679053|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.24|||||TWO_SIDED|90.0|0.12|0.47|||||Ratio is MK-1064/placebo|Analysis used a step-down approach. Mean log treatment difference of the highest MK-1064 dose versus placebo (MK-1064 - placebo) and 90% confidence interval (CI) were computed and back-transformed to obtain the 90% CI interval for LPS treatment ratio. If the CI lies completely below 1, testing continued to next lower MK-1064 dose. The hypothesis that MK-1064 is superior to placebo in decreasing LPS was supported if the CI lies below 1 for at least one dose.||0.47|0.12|
72576298|NCT02549027|144679053|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.21|||||TWO_SIDED|90.0|0.1|0.41|||||Ratio is MK-1064/placebo|Analysis used a step-down approach. Mean log treatment difference of the highest MK-1064 dose versus placebo (MK-1064 - placebo) and 90% CI were computed and back-transformed to obtain the 90% CI interval for LPS treatment ratio. If the CI lies completely below 1, testing continued to next lower MK-1064 dose. The hypothesis that MK-1064 is superior to placebo in decreasing LPS was supported if the CI lies below 1 for at least one dose.||0.41|0.10|
72576299|NCT02549027|144679053|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.15|||||TWO_SIDED|90.0|0.08|0.3|||||Ratio is MK-1064/placebo|Analysis used a step-down approach. Mean log treatment difference of the highest MK-1064 dose versus placebo (MK-1064 - placebo) and 90% CI were computed and back-transformed to obtain the 90% CI interval for LPS treatment ratio. If the CI lies completely below 1, testing continued to next lower MK-1064 dose. The hypothesis that MK-1064 is superior to placebo in decreasing LPS was supported if the CI lies below 1 for at least one dose.||0.30|0.08|
72576300|NCT02549027|144679054|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.05|||||TWO_SIDED|90.0|0.02|0.11|||||Ratio is MK-6096/placebo|Mean log treatment difference of MK-6096 versus placebo (MK-6096 - placebo) and 90% CI were computed and back-transformed to obtain the 90% CI interval for LPS treatment ratio.||0.11|0.02|
72576301|NCT02549027|144679057|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.85|||||TWO_SIDED|90.0|0.67|1.07|||||Ratio is MK-1064/placebo|Analysis used a step-down approach. Mean log treatment difference of the highest MK-1064 dose versus placebo (MK-1064 - placebo) and 90% CI were computed and back-transformed to obtain the 90% CI interval for WASO treatment ratio. If the CI lies completely below 1, testing continued to next lower MK-1064 dose. The hypothesis that MK-1064 is superior to placebo in decreasing WASO was supported if the CI lies below 1 for at least one dose.||1.07|0.67|
72576302|NCT02549027|144679057|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.68|||||TWO_SIDED|90.0|0.54|0.86|||||Ratio is MK-1064/placebo|Analysis used a step-down approach. Mean log treatment difference of the highest MK-1064 dose versus placebo (MK-1064 - placebo) and 90% CI were computed and back-transformed to obtain the 90% CI interval for WASO treatment ratio. If the CI lies completely below 1, testing continued to next lower MK-1064 dose. The hypothesis that MK-1064 is superior to placebo in decreasing WASO was supported if the CI lies below 1 for at least one dose.||0.86|0.54|
72576303|NCT02549027|144679057|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.75|||||TWO_SIDED|90.0|0.6|0.95|||||Ratio is MK-1064/placebo|Analysis used a step-down approach. Mean log treatment difference of the highest MK-1064 dose versus placebo (MK-1064 - placebo) and 90% CI were computed and back-transformed to obtain the 90% CI interval for WASO treatment ratio. If the CI lies completely below 1, testing continued to next lower MK-1064 dose. The hypothesis that MK-1064 is superior to placebo in decreasing WASO was supported if the CI lies below 1 for at least one dose.||0.95|0.60|
72576304|NCT02549027|144679058|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.63|||||TWO_SIDED|90.0|0.5|0.79|||||Ratio is MK-6096/placebo|Mean log treatment difference of MK-6096 versus placebo (MK-6096 - placebo) and 90% CI were computed and back-transformed to obtain the 90% CI interval for WASO treatment ratio.||0.79|0.50|
72576305|NCT02549027|144679059|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.59|||||TWO_SIDED|90.0|-12.01|17.2|||||Difference is MK-1064 - placebo|Analysis used a step-up approach. Mean treatment difference in change from baseline of the lowest MK-1064 dose versus placebo (MK-1064 - placebo) and 90% CI were computed. If the CI lies completely below 25 milliseconds, testing continued to the next higher MK-1064 dose. The hypothesis that at least one dose of MK-1064 does not produce psychomotor impairment versus placebo as assessed by CRT will be supported if the CI lies below 25 milliseconds for at least one dose.||17.20|-12.01|
72369255|NCT00611026|144248562|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.2||0.0374|TWO_SIDED|95.0|-0.7|0.0|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.|Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.|Treatment difference fesoterodine vs placebo at Week 1.||-0.0|-0.7|0.0374
72576306|NCT02549027|144679059|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.28|||||TWO_SIDED|90.0|-9.33|19.88|||||Difference is MK-1064 - placebo|Analysis used a step-up approach. Mean treatment difference in change from baseline of the lowest MK-1064 dose versus placebo (MK-1064 - placebo) and 90% CI were computed. If the CI lies completely below 25 milliseconds, testing continued to the next higher MK-1064 dose. The hypothesis that at least one dose of MK-1064 does not produce psychomotor impairment versus placebo as assessed by CRT will be supported if the CI lies below 25 milliseconds for at least one dose.||19.88|-9.33|
72576307|NCT02549027|144679059|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.38|||||TWO_SIDED|90.0|-8.23|20.98|||||Difference is MK-1064 - placebo|Analysis used a step-up approach. Mean treatment difference in change from baseline of the lowest MK-1064 dose versus placebo (MK-1064 - placebo) and 90% CI were computed. If the CI lies completely below 25 milliseconds, testing continued to the next higher MK-1064 dose. The hypothesis that at least one dose of MK-1064 does not produce psychomotor impairment versus placebo as assessed by CRT will be supported if the CI lies below 25 milliseconds for at least one dose.||20.98|-8.23|
72627974|NCT04881760|144784147|SUPERIORITY||Risk Difference (RD)|81.0|||<|0.001|TWO_SIDED|95.0|69.0|94.0|||Regression, Logistic|||||94|69|<0.001
72627975|NCT04881760|144784147|SUPERIORITY||Risk Difference (RD)|82.0|||<|0.001|TWO_SIDED|95.0|71.0|94.0|||Regression, Logistic|||||94|71|<0.001
72627976|NCT04881760|144784147|SUPERIORITY||Risk Difference (RD)|84.0|||<|0.001|TWO_SIDED|95.0|74.0|94.0|||Regression, Logistic|||||94|74|<0.001
72627977|NCT04881760|144784148|SUPERIORITY||Risk Difference (RD)|9.0||||0.029|TWO_SIDED|95.0|1.0|17.0|||Regression, Logistic|||||17|1|0.029
72627978|NCT04881760|144784148|SUPERIORITY||Risk Difference (RD)|27.0|||<|0.001|TWO_SIDED|95.0|11.0|43.0|||Regression, Logistic|||||43|11|<0.001
72576308|NCT02549027|144679060|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.3|||||TWO_SIDED|90.0|-7.1|25.7|||||Difference is MK-6096 - placebo|Mean treatment difference in change from baseline of MK-6096 versus placebo (MK-6096 - placebo) and 90% CI were computed.||25.70|-7.10|
72576309|NCT01421511|144679069|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI was calculated for the observed differences in the early clinical response rates at 48 to 72 Hours after the first infusion of study drug using the method of Miettinen and Nurminen without stratification. Noninferiority was concluded if the lower limit of the 95% CI was greater than -10%.|Risk Difference (RD)|2.6|||||TWO_SIDED|95.0|-3.0|8.2|||||Risk difference corresponds to the tedizolid responder rate minus the linezolid responder rate.|||8.2|-3.0|
72576310|NCT01421511|144679070|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI was calculated for the observed differences in the programmatic clinical response at the EOT visit using the method of Miettinen and Nurminen without stratification. Noninferiority was concluded if the lower limit of the 95% CI was greater than -10% and the conditions of the hierarchical testing procedure were met.|Risk Difference (RD)|-1.0|||||TWO_SIDED|95.0|-6.1|4.1||Hierarchical testing procedure of Westfall and Krishen used to control for inflation of the overall type I error rate. If NI is declared for the primary, NI will be tested for the secondary outcomes in this order: Secondary Outcomes Measures 2 to 5.|||Risk difference corresponds to the tedizolid clinical response rate minus the linezolid clinical response rate.|||4.1|-6.1|
72576311|NCT01421511|144679071|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI was calculated for the observed differences in the clinical response rate based on the Investigator's assessment of clinical response at the EOT Visit using the method of Miettinen and Nurminen without stratification. Noninferiority was concluded if the lower limit of the 95% CI was greater than -10% and the conditions of the hierarchical testing procedure were met.|Risk Difference (RD)|-4.1|||||TWO_SIDED|95.0|-8.8|0.3|||||Risk difference corresponds to the tedizolid clinical response rate minus the linezolid clinical response rate.|||0.3|-8.8|
72576312|NCT01421511|144679072|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI was calculated for the observed differences in the clinical success rate based on the Investigator's assessment of clinical response at the PTE Visit using the method of Miettinen and Nurminen without stratification. Noninferiority was concluded if the lower limit of the 95% CI was greater than -10% and the conditions of the hierarchical testing procedure were met.|Risk Difference (RD)|0.3|||||TWO_SIDED|95.0|-4.8|5.3|||||Risk difference corresponds to the tedizolid clinical success rate minus the linezolid clinical success rate.|||5.3|-4.8|
72576313|NCT01421511|144679073|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI was calculated for the observed differences in the clinical success rate based on the Investigator's assessment of clinical response at the PTE Visit using the method of Miettinen and Nurminen without stratification. Noninferiority was concluded if the lower limit of the 95% CI was greater than -10% and the conditions of the hierarchical testing procedure were met.|Risk Difference (RD)|-3.7|||||TWO_SIDED|95.0|-7.7|0.2|||||Risk difference corresponds to the tedizolid clinical success rate minus the linezolid clinical success rate.|||0.2|-7.7|
72576314|NCT01421511|144679074|SUPERIORITY_OR_OTHER||Risk Difference (RD)|1.2|||||TWO_SIDED|95.0|-3.3|5.6|||||Risk difference corresponds to the tedizolid clinical response rate minus the linezolid clinical response rate.|A two-sided 95% CI was calculated for the observed differences in the clinical response rate based on the Investigator's assessment of clinical response at the 48-72 Hour Visit using the method of Miettinen and Nurminen without stratification.||5.6|-3.3|
72627979|NCT04881760|144784148|SUPERIORITY||Risk Difference (RD)|43.0|||<|0.001|TWO_SIDED|95.0|26.0|60.0|||Regression, Logistic|||||60|26|<0.001
72627980|NCT04881760|144784148|SUPERIORITY||Risk Difference (RD)|49.0|||<|0.001|TWO_SIDED|95.0|33.0|66.0|||Regression, Logistic|||||66|33|<0.001
72627981|NCT04881760|144784148|SUPERIORITY||Risk Difference (RD)|67.0|||<|0.001|TWO_SIDED|95.0|51.0|83.0|||Regression, Logistic|||||83|51|<0.001
72627982|NCT04881760|144784148|SUPERIORITY||Risk Difference (RD)|68.0|||<|0.001|TWO_SIDED|95.0|56.0|80.0|||Regression, Logistic|||||80|56|<0.001
72627983|NCT04881760|144784149|SUPERIORITY||Risk Difference (RD)|15.0||||0.002|TWO_SIDED|95.0|6.0|24.0|||Regression, Logistic|||||24|6|0.002
72627984|NCT04881760|144784149|SUPERIORITY||Risk Difference (RD)|53.0|||<|0.001|TWO_SIDED|95.0|36.0|70.0|||Regression, Logistic|||||70|36|<0.001
72627985|NCT04881760|144784149|SUPERIORITY||Risk Difference (RD)|63.0|||<|0.001|TWO_SIDED|95.0|47.0|79.0|||Regression, Logistic|||||79|47|<0.001
72627986|NCT04881760|144784149|SUPERIORITY||Risk Difference (RD)|71.0|||<|0.001|TWO_SIDED|95.0|55.0|87.0|||Regression, Logistic|||||87|55|<0.001
72627987|NCT04881760|144784149|SUPERIORITY||Risk Difference (RD)|75.0|||<|0.001|TWO_SIDED|95.0|62.0|89.0|||Regression, Logistic|||||89|62|<0.001
72627988|NCT04881760|144784149|SUPERIORITY||Risk Difference (RD)|82.0|||<|0.001|TWO_SIDED|95.0|71.0|92.0|||Regression, Logistic|||||92|71|<0.001
72627989|NCT04881760|144784150|SUPERIORITY||LS Mean difference (Final Values)|-6.46|||<|0.001|TWO_SIDED|95.0|-8.36|-4.56|||Mixed Models Analysis|||||-4.56|-8.36|<0.001
72627990|NCT04881760|144784150|SUPERIORITY||LS Mean difference (Final Values)|-11.32|||<|0.001|TWO_SIDED|95.0|-13.34|-9.3|||Mixed Models Analysis|||||-9.30|-13.34|<0.001
72627991|NCT04881760|144784150|SUPERIORITY||LS Mean difference (Final Values)|-13.52|||<|0.001|TWO_SIDED|95.0|-15.99|-11.05|||Mixed Models Analysis|||||-11.05|-15.99|<0.001
72627992|NCT04881760|144784150|SUPERIORITY||LS Mean difference (Final Values)|-16.43|||<|0.001|TWO_SIDED|95.0|-18.41|-14.45|||Mixed Models Analysis|||||-14.45|-18.41|<0.001
72541821|NCT03125915|144613422|SUPERIORITY||Beta|-0.25||||0.49|TWO_SIDED|95.0|-0.96|0.46||A multi-level latent growth curve (LGC) with an intercept and linear slope was specified. The main effects of SUM and CT video were modeled at level 2 in addition to their interaction. Drug use was specified as a binomial distribution.|multi-level latent growth curve||6-month follow-up, effect of SUM among those who did not view the CT video.|||0.46|-0.96|0.49
72541822|NCT03125915|144613422|SUPERIORITY||Beta|-0.53||||0.1|TWO_SIDED|95.0|-1.16|0.11||A multi-level latent growth curve (LGC) with an intercept and linear slope was specified. The main effects of SUM and CT video were modeled at level 2 in addition to their interaction. Drug use was specified as a binomial distribution.|multi-level latent growth curve||6-month follow-up, effect of CT video among those who completed SUM.|||0.11|-1.16|0.10
72576315|NCT01421511|144679075|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.9|||||TWO_SIDED|95.0|-3.2|4.9|||||Risk difference corresponds to the tedizolid clinical response rate minus the linezolid clinical response rate.|A two-sided 95% CI was calculated for the observed differences in the clinical response rate based on the Investigator's assessment of clinical response at the Day 7 Visit using the method of Miettinen and Nurminen without stratification.||4.9|-3.2|
72576316|NCT00469144|144679132|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||100 Days, Between Arms: Participants in CR||||0.9
72576317|NCT00469144|144679132|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||100 Days, Between Arms: Participants not in CR||||0.4
72576318|NCT00469144|144679132|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||1 Year, Between Arms: Participants in CR||||0.7
72576319|NCT00469144|144679132|SUPERIORITY_OR_OTHER_LEGACY|||||||0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||1 Year, Between Arms: Participants not in CR||||0.05
72627993|NCT04881760|144784150|SUPERIORITY||LS Mean difference (Final Values)|-18.48|||<|0.001|TWO_SIDED|95.0|-20.93|-16.04|||Mixed Models Analysis|||||-16.04|-20.93|<0.001
72627994|NCT04881760|144784150|SUPERIORITY||LS Mean difference (Final Values)|-17.26|||<|0.001|TWO_SIDED|95.0|-19.11|-15.4|||Mixed Models Analysis|||||-15.40|-19.11|<0.001
72627995|NCT04881760|144784151|SUPERIORITY||LS Mean difference (Final Values)|-7.53|||<|0.001|TWO_SIDED|95.0|-10.18|-4.88|||Mixed Models Analysis|||||-4.88|-10.18|<0.001
72627996|NCT04881760|144784151|SUPERIORITY||LS Mean difference (Final Values)|-15.48|||<|0.001|TWO_SIDED|95.0|-19.35|-11.6|||Mixed Models Analysis|||||-11.60|-19.35|<0.001
72627997|NCT04881760|144784151|SUPERIORITY||LS Mean difference (Final Values)|-17.29|||<|0.001|TWO_SIDED|95.0|-21.19|-13.39|||Mixed Models Analysis|||||-13.39|-21.19|<0.001
72541823|NCT03125915|144613422|SUPERIORITY||Beta|-0.02||||0.96|TWO_SIDED|95.0|-0.6|0.64||A multi-level latent growth curve (LGC) with an intercept and linear slope was specified. The main effects of SUM and CT video were modeled at level 2 in addition to their interaction. Drug use was specified as a binomial distribution.|multi-level latent growth curve||6-month follow-up, effect of CT video among those who did not complete SUM.|||0.64|-0.60|0.96
72576320|NCT01775189|144679138|SUPERIORITY_OR_OTHER||Least Squares (LS) mean Difference|9.5||||0.0001|TWO_SIDED|95.0|4.8|14.2||P-value was adjusted using Benjamini-Hochberg method.|Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||14.2|4.8|0.0001
72627998|NCT04881760|144784151|SUPERIORITY||LS Mean difference (Final Values)|-21.69|||<|0.001|TWO_SIDED|95.0|-25.25|-18.12|||Mixed Models Analysis|||||-18.12|-25.25|<0.001
72627999|NCT04881760|144784151|SUPERIORITY||LS Mean difference (Final Values)|-24.04|||<|0.001|TWO_SIDED|95.0|-27.72|-20.36|||Mixed Models Analysis|||||-20.36|-27.72|<0.001
72628000|NCT04881760|144784151|SUPERIORITY||LS Mean difference (Final Values)|-24.34|||<|0.001|TWO_SIDED|95.0|-27.4|-21.27|||Mixed Models Analysis|||||-21.27|-27.40|<0.001
72576321|NCT01775189|144679138|SUPERIORITY_OR_OTHER||LS Mean Difference|-32.3|||<|0.0001|TWO_SIDED|95.0|-37.0|-27.6||P-value was adjusted using Benjamini-Hochberg method.|Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-27.6|-37.0|<0.0001
72576322|NCT01775189|144679138|SUPERIORITY_OR_OTHER||LS Mean Difference|9.1||||0.0002|TWO_SIDED|95.0|4.5|13.8||P-value was adjusted using Benjamini-Hochberg method.|Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||13.8|4.5|0.0002
72628001|NCT04881760|144784152|SUPERIORITY||LS Mean difference (Final Values)|-2.15|||<|0.001|TWO_SIDED|95.0|-2.8|-1.5|||Mixed Models Analysis|||||-1.50|-2.80|<0.001
72628002|NCT04881760|144784152|SUPERIORITY||LS Mean difference (Final Values)|-3.98|||<|0.001|TWO_SIDED|95.0|-4.66|-3.29|||Mixed Models Analysis|||||-3.29|-4.66|<0.001
72628003|NCT04881760|144784152|SUPERIORITY||LS Mean difference (Final Values)|-4.64|||<|0.001|TWO_SIDED|95.0|-5.46|-3.82|||Mixed Models Analysis|||||-3.82|-5.46|<0.001
72628004|NCT04881760|144784152|SUPERIORITY||LS Mean difference (Final Values)|-5.66|||<|0.001|TWO_SIDED|95.0|-6.34|-4.99|||Mixed Models Analysis|||||-4.99|-6.34|<0.001
72628005|NCT04881760|144784152|SUPERIORITY||LS Mean difference (Final Values)|-6.35|||<|0.001|TWO_SIDED|95.0|-7.17|-5.53|||Mixed Models Analysis|||||-5.53|-7.17|<0.001
72628006|NCT04881760|144784152|SUPERIORITY||LS Mean difference (Final Values)|-5.95|||<|0.001|TWO_SIDED|95.0|-6.59|-5.32|||Mixed Models Analysis|||||-5.32|-6.59|<0.001
72628007|NCT04881760|144784153|SUPERIORITY||LS Mean difference (Final Values)|-2.5|||<|0.001|TWO_SIDED|95.0|-3.42|-1.57|||Mixed Models Analysis|||||-1.57|-3.42|<0.001
72628008|NCT04881760|144784153|SUPERIORITY||LS Mean difference (Final Values)|-5.42|||<|0.001|TWO_SIDED|95.0|-6.81|-4.03|||Mixed Models Analysis|||||-4.03|-6.81|<0.001
72628009|NCT04881760|144784153|SUPERIORITY||LS Mean difference (Final Values)|-5.95|||<|0.001|TWO_SIDED|95.0|-7.23|-4.67|||Mixed Models Analysis|||||-4.67|-7.23|<0.001
72628010|NCT04881760|144784153|SUPERIORITY||LS Mean difference (Final Values)|-7.4|||<|0.001|TWO_SIDED|95.0|-8.62|-6.18|||Mixed Models Analysis|||||-6.18|-8.62|<0.001
72628011|NCT04881760|144784153|SUPERIORITY||LS Mean difference (Final Values)|-8.3|||<|0.001|TWO_SIDED|95.0|-9.55|-7.05|||Mixed Models Analysis|||||-7.05|-9.55|<0.001
72541824|NCT01123980|144613423|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was considered to be confirmed if the upper bound of the two-sided 95% confidence interval (CI) was below or equal to 0.4% or equivalent if the p-value for the one-sided test of H0: D \> 0.4% against HA: D =\< 0.4%, was less than or equal to 2.5%, where D is the mean treatment difference (investigational product minus comparator). Furthermore, superiority of BIAsp 30 OD over insulin glargine OD was shown if the upper limit of the 95% CI for the difference is lower than 0%|Mean Difference (Net)|-0.12|STANDARD_ERROR_OF_MEAN|0.07|<|0.001||95.0|-0.25|0.02||The p-values correspond to one-sided hypotheses of either non-inferiority or superiority, statistical significance level is 2.5%.|ANCOVA|The estimates are from a normal linear regression model with treatment, country and previous OADs as factors and baseline HbA1c as a covariate||H0: The mean treatment difference (BIAsp 30 minus insulin glargine) \> 0.4%. HA: The mean treatment difference (BIAsp 30 minus insulin glargine) =\< 0.4%. Sample size was calculated to achieve a power of at least 90%, assuming an equal change in HbA1c and a common standard deviation of 1.25%||0.02|-0.25|< 0.001
72576323|NCT01775189|144679138|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4||||0.8806|TWO_SIDED|95.0|-5.0|4.3||P-value was adjusted using Benjamini-Hochberg method.|Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||4.3|-5.0|0.8806
72541825|NCT01123980|144613424|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.03|||<|0.001||95.0|-0.24|0.19||P-value for parallelism is overall test for parallel time profiles between treatment groups.|Mixed Models Analysis||Before breakfast|Repeated measures mixed model with an unstructured residual covarience matrix, including treatment, time, the treatment-by-time interaction, country and previous OADs as factors.||0.19|-0.24|<0.001
72541826|NCT01123980|144613424|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.07|||<|0.001||95.0|-0.45|0.58||P-value for parallelism is overall test for parallel time profiles between treatment groups.|Mixed Models Analysis||Two hours after breakfast|Repeated measures mixed model with an unstructured residual covarience matrix, including treatment, time, the treatment-by-time interaction, country and previous OADs as factors.||0.58|-0.45|<0.001
72541827|NCT01123980|144613424|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.14|||<|0.001||95.0|-0.31|0.58||P-value for parallelism is overall test for parallel time profiles between treatment groups.|Mixed Models Analysis||Before lunch|Repeated measures mixed model with an unstructured residual covarience matrix, including treatment, time, the treatment-by-time interaction, country and previous OADs as factors.||0.58|-0.31|<0.001
72541828|NCT01123980|144613424|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.28|||<|0.001||95.0|-0.26|0.82||P-value for parallelism is overall test for parallel time profiles between treatment groups.|Mixed Models Analysis||Two hours after lunch|Repeated measures mixed model with an unstructured residual covarience matrix, including treatment, time, the treatment-by-time interaction, country and previous OADs as factors.||0.82|-0.26|<0.001
72541829|NCT01123980|144613424|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.64|||<|0.001||95.0|0.22|1.06||P-value for parallelism is overall test for parallel time profiles between treatment groups.|Mixed Models Analysis||Before dinner|Repeated measures mixed model with an unstructured residual covarience matrix, including treatment, time, the treatment-by-time interaction, country and previous OADs as factors.||1.06|0.22|<0.001
72541830|NCT01123980|144613424|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.51|||<|0.001||95.0|-2.03|-1.0||P-value for parallelism is overall test for parallel time profiles between treatment groups.|Mixed Models Analysis||Two hours after dinner|Repeated measures mixed model with an unstructured residual covarience matrix, including treatment, time, the treatment-by-time interaction, country and previous OADs as factors.||-1.00|-2.03|<0.001
72541831|NCT01123980|144613424|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.25|||<|0.001||95.0|-1.73|-0.78||P-value for parallelism is overall test for parallel time profiles between treatment groups.|Mixed Models Analysis||Bedtime|Repeated measures mixed model with an unstructured residual covarience matrix, including treatment, time, the treatment-by-time interaction, country and previous OADs as factors.||-0.78|-1.73|<0.001
72576324|NCT01775189|144679138|SUPERIORITY_OR_OTHER||LS Mean Difference|41.4|||<|0.0001|TWO_SIDED|95.0|36.8|46.1||P-value was adjusted using Benjamini-Hochberg method.|Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||46.1|36.8|<0.0001
72628012|NCT04881760|144784153|SUPERIORITY||LS Mean difference (Final Values)|-8.42|||<|0.001|TWO_SIDED|95.0|-9.49|-7.35|||Mixed Models Analysis|||||-7.35|-9.49|<0.001
72541832|NCT01123980|144613424|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.47|||<|0.001||95.0|-0.81|-0.13||P-value for parallelism is overall test for parallel time profiles between treatment groups.|Mixed Models Analysis||02 - 04 a.m.|Repeated measures mixed model with an unstructured residual covarience matrix, including treatment, time, the treatment-by-time interaction, country and previous OADs as factors.||-0.13|-0.81|<0.001
72541833|NCT01123980|144613424|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.17|||<|0.001||95.0|-0.06|0.4||P-value for parallelism is overall test for parallel time profiles between treatment groups.|Mixed Models Analysis||Before breakfast the following day|Repeated measures mixed model with an unstructured residual covarience matrix, including treatment, time, the treatment-by-time interaction, country and previous OADs as factors.||0.40|-0.06|<0.001
72576325|NCT01775189|144679138|SUPERIORITY_OR_OTHER||LS Mean Difference|41.8|||<|0.0001|TWO_SIDED|95.0|37.1|46.4||P-value was adjusted using Benjamini-Hochberg method.|Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||46.4|37.1|<0.0001
72628013|NCT04881760|144784154|SUPERIORITY||LS Mean difference (Final Values)|-2.82||||0.022|TWO_SIDED|95.0|-5.23|-0.41|||Mixed Models Analysis|||||-0.41|-5.23|0.022
72410113|NCT02447991|144328599|SUPERIORITY||||||<|0.33||||||Significance level p \< 0.05|Chi-squared, Corrected|This analysis applies to proportion of treated episodes.||Hypothesis: Rizatriptan will be superior to placebo in reducing the severity of vertigo as measured by the proportion of treated episodes in which subjects experience a reduction in severity rating from Grade 3/2 to Grade 1/0 at 1 hour after taking study medication.||||<0.33
72410114|NCT02447991|144328600|SUPERIORITY||||||<|0.18||||||Signficant at p \< 0.05|Chi-squared, Corrected|This analysis applies to proportion of treated episodes||Hypothesis: Rizatriptan will be superior to placebo in reducing the severity of unsteadiness/dizziness as measured by the proportion of treated episodes in which subjects experience a reduction in severity rating from Grade 3/2 to Grade 1/0 at 1 hour after taking study medication||||<0.18
72410115|NCT02447991|144328601|SUPERIORITY||||||<|0.62||||||Significance threshold p\<0.05|Chi-squared, Corrected|This analysis applies to proportion of treated episodes.||Hypothesis: Rizatriptan will be superior to placebo in reducing the severity of vertigo as measured by the proportion of treated episodes in which subjects experience freedom from vestibular symptoms (i.e., severity rating of Grade 0) at 1 hour after taking study medication.||||<0.62
72541834|NCT01123980|144613425|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.96||||0.8583||95.0|0.64|1.46|||Regression, Logistic||The odds ratio and 95% confidence interval is for the HbA1c less than 7% treatment target were included.|The responder analysis was based on logistic regression model using treatment, country and previous OAD therapy (with or without a third OAD) as factors and baseline HbA1c as covariate.||1.46|0.64|0.8583
72541835|NCT01123980|144613426|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.07||||0.8013||95.0|0.64|1.79|||Regression, Logistic||The odds ratio and 95% confidence interval is for the HbA1c below or equal to 6.5% treatment target were included.|The responder analysis was based on logistic regression model using treatment, country and previous OAD therapy (with or without a third OAD) as factors and baseline HbA1c as covariate.||1.79|0.64|0.8013
72541836|NCT02094937|144613446|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.88|||||TWO_SIDED|95.0|0.31|2.49||||||||2.49|0.31|
72541837|NCT02094937|144613446|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.79|||||TWO_SIDED|95.0|0.28|2.19||||||||2.19|0.28|
72541838|NCT02094937|144613447|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.93|||||TWO_SIDED|95.0|0.9|4.12||||||||4.12|0.90|
72541839|NCT02094937|144613447|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.45|||||TWO_SIDED|95.0|0.66|3.2||||||||3.20|0.66|
72541840|NCT02450760|144613454|SUPERIORITY|||||||0.29|||||||Wilcoxon (Mann-Whitney)|||||||0.29
72541841|NCT02450760|144613455|SUPERIORITY|||||||0.95|||||||t-test, 2 sided|||||||0.95
72541842|NCT02450760|144613459|SUPERIORITY|||||||0.15|||||||Chi-squared|||||||0.15
72541843|NCT02450760|144613460|SUPERIORITY|||||||0.83|||||||Chi-squared|||||||0.83
72541844|NCT02450760|144613461|SUPERIORITY|||||||0.26|||||||Chi-squared|||||||0.26
72541845|NCT03053622|144613464|OTHER||Ratio of Geometric Least Squares Means|0.996|||||TWO_SIDED|90.0|0.807|1.23||||||||1.23|0.807|
72541846|NCT03053622|144613464|OTHER||Ratio of Geometric Least Squares Means|0.729|||||TWO_SIDED|90.0|0.591|0.898||||||||0.898|0.591|
72541847|NCT03053622|144613464|OTHER||Ratio of Geometric Least Squares Means|0.422|||||TWO_SIDED|90.0|0.343|0.518||||||||0.518|0.343|
72541848|NCT03053622|144613464|OTHER||Ratio of Geometric Least Squares Means|0.307|||||TWO_SIDED|90.0|0.249|0.379||||||||0.379|0.249|
72541849|NCT03053622|144613465|OTHER||Ratio of Geometric Least Squares Means|0.986|||||TWO_SIDED|90.0|0.81|1.2||||||||1.20|0.810|
72541850|NCT03053622|144613465|OTHER||Ratio of Geometric Least Squares Means|0.753|||||TWO_SIDED|90.0|0.619|0.916||||||||0.916|0.619|
72541851|NCT03053622|144613466|OTHER||Median Difference (Final Values)|0.28|||||TWO_SIDED|90.0|-0.1|48.4||||||||48.40|-0.10|
72541852|NCT03053622|144613466|OTHER||Median Difference (Final Values)|0.25|||||TWO_SIDED|90.0|-0.25|23.97|||||"In this outcome, the median difference is not calculated by subtracting two observations, it is derived by Hodges-Lehmann approach to estimating location shift. This method will give the value of 0.25."|||23.97|-0.25|
72541853|NCT00581386|144613469|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.125||||0.013||95.0|1.27|7.67|||Regression, Logistic|Logistic regression Number of obs = 217, LR chi2(2)=10.89, Prob\>chi2=0.0043,Log likelihood = -112.87788, Pseudo R2=0.0460|this is a simple odds ratio|||7.67|1.27|0.013
72541854|NCT00581386|144613469|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.81||||0.003||95.0|1.57|9.29|||Odds ratio|||||9.29|1.57|0.003
72541855|NCT00581386|144613470|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.006||||0.006||95.0|||||t-test, 2 sided|||||||0.006
72541856|NCT00581386|144613471|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.088||||0.003||95.0|1.728|14.99|||Regression, Logistic|||||14.99|1.728|0.003
72541857|NCT00581386|144613471|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|7.22||||0.0004||95.0|2.419|21.527|||Regression, Logistic|||||21.527|2.419|0.0004
72541858|NCT01355523|144613473|SUPERIORITY_OR_OTHER|||||||0.008||95.0|||||Chi-squared|||||||0.008
72541859|NCT01355523|144613473|SUPERIORITY_OR_OTHER||Number need to treat|2.95|||||TWO_SIDED|95.0|1.703|11.024||||||||11.024|1.703|
72541860|NCT01355523|144613473|SUPERIORITY_OR_OTHER||Relative Risk|0.25|||||TWO_SIDED|95.0|0.076|0.797||||||||0.797|0.076|
72541861|NCT01355523|144613474|SUPERIORITY_OR_OTHER|||||||0.125||95.0|||||Fisher Exact|||||||0.125
72541862|NCT01355523|144613475|SUPERIORITY_OR_OTHER|||||||0.46||95.0|||||Fisher Exact|||||||0.460
72541863|NCT01355523|144613476|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||Chi-squared|||||||0.002
72541864|NCT01355523|144613477|SUPERIORITY_OR_OTHER|||||||0.264||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.264
72576326|NCT01775189|144679139|SUPERIORITY_OR_OTHER||LS Mean Difference|6.6||||0.2176|TWO_SIDED|95.0|-4.0|17.1||P-value was adjusted using Benjamini-Hochberg method.|Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||17.1|-4.0|0.2176
72541865|NCT01355523|144613478|SUPERIORITY_OR_OTHER|||||||0.351||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.351
72541866|NCT01355523|144613479|SUPERIORITY_OR_OTHER|||||||0.446||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.446
72541867|NCT01355523|144613480|SUPERIORITY_OR_OTHER|||||||0.122||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.122
72541868|NCT01355523|144613481|SUPERIORITY_OR_OTHER|||||||0.907||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.907
72541869|NCT01355523|144613482|SUPERIORITY_OR_OTHER|||||||0.555||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.555
72541870|NCT01355523|144613483|SUPERIORITY_OR_OTHER|||||||0.93||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.930
72541871|NCT01355523|144613484|SUPERIORITY_OR_OTHER|||||||0.386||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.386
72541872|NCT01355523|144613485|SUPERIORITY_OR_OTHER|||||||0.241||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.241
72541873|NCT01355523|144613486|SUPERIORITY_OR_OTHER|||||||0.339||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.339
72541874|NCT01355523|144613487|SUPERIORITY_OR_OTHER|||||||0.578||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.578
72541875|NCT01355523|144613488|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Wilcoxon (Mann-Whitney)|||||||1.000
72541876|NCT01406873|144613515|SUPERIORITY||||||<|0.01|||||||ANCOVA|||||||<0.01
72576327|NCT01775189|144679139|SUPERIORITY_OR_OTHER||LS Mean Difference|-54.6|||<|0.0001|TWO_SIDED|95.0|-65.1|-44.1||P-value was adjusted using Benjamini-Hochberg method.|Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-44.1|-65.1|<0.0001
72628014|NCT04881760|144784154|SUPERIORITY||LS Mean difference (Final Values)|-7.73|||<|0.001|TWO_SIDED|95.0|-10.32|-5.13|||Mixed Models Analysis|||||-5.13|-10.32|<0.001
72628015|NCT04881760|144784154|SUPERIORITY||LS Mean difference (Final Values)|-9.95|||<|0.001|TWO_SIDED|95.0|-12.47|-7.43|||Mixed Models Analysis|||||-7.43|-12.47|<0.001
72628016|NCT04881760|144784154|SUPERIORITY||LS Mean difference (Final Values)|-11.14|||<|0.001|TWO_SIDED|95.0|-13.72|-8.56|||Mixed Models Analysis|||||-8.56|-13.72|<0.001
72541877|NCT00207714|144613519|SUPERIORITY_OR_OTHER|||||||0.01||||||A positive test is concluded if there is a significant difference between combined golimumab and placebo groups and at least one of the pair-wise comparisons at 0.05 level.|Cochran-Mantel-Haenszel|||Null hypothesis: No difference in ACR 20 response at Week 16 between combined golimumab groups and Placebo +MTX group. Sample of 35 participants per treatment groups (140 in combined golimumab group and 35 in Placebo +MTX group) provides greater than 90% power assuming 60% golimumab response and 25 % response in Placebo +MTX.||||0.010
72541878|NCT00207714|144613519|SUPERIORITY_OR_OTHER|||||||0.056|||||||Cochran-Mantel-Haenszel|||Null hypothesis: No difference in ACR 20 response at Wk 16 between golimumab 50 mg every 4 weeks and Placebo + MTX. Sample of 35 participants per treatment groups (140 in combined golimumab group and 35 in Placebo +MTX group) provides greater than 90% power assuming 60% golimumab response and 25% response in placebo.||||0.056
72541879|NCT00207714|144613519|SUPERIORITY_OR_OTHER|||||||0.281|||||||Cochran-Mantel-Haenszel|||Null hypothesis: No difference in ACR 20 response at Wk 16 between Golimumab 50 mg every 2 or 4 Weeks and Placebo + MTX. Sample of 35 participants per treatment groups (140 in combined golimumab group and 35 in Placebo +MTX group) provides greater than 90% power assuming 60% golimumab response and 25% response in placebo.||||0.281
72541880|NCT00207714|144613519|SUPERIORITY_OR_OTHER|||||||0.119|||||||Cochran-Mantel-Haenszel|||Null hypothesis: No difference in ACR 20 response at Wk 16 between Golimumab 100 mg every 4 weeks and Placebo + MTX. Sample of 35 participants per treatment groups (140 in combined golimumab group and 35 in Placebo +MTX group) provides greater than 90% power assuming 60% golimumab response and 25% response in placebo.||||0.119
72541881|NCT00207714|144613519|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||Null hypothesis: No difference in ACR 20 response at Wk 16 between Golimumab 100 mg every 2 or 4 Weeks and Placebo + MTX. Sample of 35 participants per treatment groups (140 in combined golimumab group and 35 in Placebo +MTX group) provides greater than 90% power assuming 60% golimumab response and 25% response in placebo.||||<0.001
72541882|NCT00207714|144613520|SUPERIORITY_OR_OTHER|||||||0.001|||||||ANOVA on van der Waerden normal scores.|||No difference in ACRn scores measured as percentage of improvement from baseline at Week 16 between Placebo + MTX and combined golimumab groups.||||0.001
72541883|NCT00207714|144613520|SUPERIORITY_OR_OTHER|||||||0.006|||||||ANOVA on van der Waerden normal scores.|||No difference in ACRn scores measured as percentage of improvement from baseline at Week 16 between Placebo + MTX and Golimumab 50 mg every 4 weeks||||0.006
72541884|NCT00207714|144613520|SUPERIORITY_OR_OTHER|||||||0.095|||||||ANOVA on van der Waerden normal scores.|||No difference in ACRn scores measured as percentage of improvement from baseline at Week 16 between Placebo + MTX and Golimumab 50 mg every 2 or 4 Weeks||||0.095
72541885|NCT00207714|144613520|SUPERIORITY_OR_OTHER|||||||0.01|||||||ANOVA on van der Waerden normal scores.|ANOVA on van der Waerden normal scores||No difference in ACRn scores measured as percentage of improvement from baseline at Week 16 between Placebo + MTX Golibumab 100 mg every 4 weeks||||0.010
72541886|NCT00207714|144613520|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA on van der Waerden normal scores.|||No difference in ACRn scores measured as percentage of improvement from baseline at Week 16 between Placebo + MTX Golimumab 100 mg every 2 or 4 Weeks||||<0.001
72541887|NCT02580318|144613540|OTHER||||||<|0.0001||||||the separate paired sample t-tests were conducted to compare the baseline BrAC to the BrAC after the manipulation (poor effort)|t-test, 2 sided|||this p value is calculated for poor effort||||<0.0001
72541888|NCT02580318|144613540|OTHER||||||<|0.0001||||||the separate paired sample t-tests were conducted to compare the baseline BrAC to the BrAC after the manipulation (hyperventilation - immediate)|t-test, 2 sided|||p value calculated for hyperventilation (immediate)||||<0.0001
72541889|NCT02580318|144613540|OTHER||||||<|0.0001||||||the separate paired sample t-tests were conducted to compare the baseline BrAC to the BrAC after the manipulation (5 minutes after hyperventilation)|t-test, 2 sided|||p value calculated for hyperventilation (after 5 minutes)||||<0.0001
72628017|NCT04881760|144784154|SUPERIORITY||LS Mean difference (Final Values)|-12.38|||<|0.001|TWO_SIDED|95.0|-14.87|-9.9|||Mixed Models Analysis|||||-9.90|-14.87|<0.001
72628018|NCT04881760|144784154|SUPERIORITY||LS Mean difference (Final Values)|-11.73|||<|0.001|TWO_SIDED|95.0|-14.04|-9.43|||Mixed Models Analysis|||||-9.43|-14.04|<0.001
72541890|NCT02580318|144613540|OTHER||||||<|0.0001||||||the separate paired sample t-tests were conducted to compare the baseline BrAC to the BrAC after the manipulation (10 minutes after hyperventilation)|t-test, 2 sided|||p value calculated for hyperventilation (after 10 minutes)||||<0.0001
72541891|NCT02580318|144613540|OTHER||||||<|0.0001||||||the separate paired sample t-tests were conducted to compare the baseline BrAC to the BrAC after the manipulation (immediately after drinking water)|t-test, 2 sided|||p value calculated for drinking water (immediate)||||<0.0001
72541892|NCT02580318|144613540|OTHER||||||<|0.0001||||||the separate paired sample t-tests were conducted to compare the baseline BrAC to the BrAC after the manipulation (5 minutes after drinking water)|t-test, 2 sided|||p value calculated for drinking water (5 minutes)||||<0.0001
72628019|NCT04881760|144784155|SUPERIORITY||LS Mean difference (Final Values)|-3.84||||0.01|TWO_SIDED|95.0|-6.77|-0.91|||Mixed Models Analysis|||||-0.91|-6.77|0.010
72628020|NCT04881760|144784155|SUPERIORITY||LS Mean difference (Final Values)|-11.94|||<|0.001|TWO_SIDED|95.0|-15.54|-8.33|||Mixed Models Analysis|||||-8.33|-15.54|<0.001
72628021|NCT04881760|144784155|SUPERIORITY||LS Mean difference (Final Values)|-12.22|||<|0.001|TWO_SIDED|95.0|-16.11|-8.33|||Mixed Models Analysis|||||-8.33|-16.11|<0.001
72628022|NCT04881760|144784155|SUPERIORITY||LS Mean difference (Final Values)|-15.88|||<|0.001|TWO_SIDED|95.0|-19.33|-12.43|||Mixed Models Analysis|||||-12.43|-19.33|<0.001
72628023|NCT04881760|144784155|SUPERIORITY||LS Mean difference (Final Values)|-15.85|||<|0.001|TWO_SIDED|95.0|-19.39|-12.31|||Mixed Models Analysis|||||-12.31|-19.39|<0.001
72628024|NCT04881760|144784155|SUPERIORITY||LS Mean difference (Final Values)|-16.95|||<|0.001|TWO_SIDED|95.0|-20.13|-13.78|||Mixed Models Analysis|||||-13.78|-20.13|<0.001
72628025|NCT00271544|144784201|SUPERIORITY_OR_OTHER||One sample proportion|0.955||||||95.0|0.92|0.955|||||1-side 95% confidence limit lower bound|||0.955|0.92|
72541893|NCT01735877|144613594|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.43|STANDARD_ERROR_OF_MEAN|1.52||0.77|||||||t-test, 2 sided|||At Baseline||||0.77
72541894|NCT01735877|144613594|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.12|||<|0.0001|TWO_SIDED|95.0|11.02|17.25|||ANCOVA|||Mean Change from baseline to 1 month||17.25|11.02|<0.0001
72541895|NCT01735877|144613594|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|22.56|||<|0.0001|TWO_SIDED|95.0|18.65|26.48|||ANCOVA|||Baseline to 3 month||26.48|18.65|<0.0001
72541896|NCT01735877|144613594|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|23.28|||<|0.0001|TWO_SIDED|95.0|18.94|27.62|||ANCOVA|||Baseline to 6 month||27.62|18.94|<0.0001
72541897|NCT01735877|144613595|SUPERIORITY_OR_OTHER|||||||0.99|||||||Chi-squared|||At Baseline||||0.99
72541898|NCT01735877|144613595|SUPERIORITY_OR_OTHER|||||||0.99|||||||Chi-squared|||At 1 month||||0.99
72541899|NCT01735877|144613595|SUPERIORITY_OR_OTHER|||||||0.03|||||||Chi-squared|||At 3 months||||0.03
72541900|NCT01735877|144613595|SUPERIORITY_OR_OTHER|||||||0.004|||||||Chi-squared|||At 6 months||||0.004
72541901|NCT01735877|144613596|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.51|STANDARD_ERROR_OF_MEAN|3.25||0.64|||||||t-test, 2 sided|||At Baseline||||0.64
72541902|NCT01735877|144613596|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.92||||0.002|TWO_SIDED|95.0|2.24|9.6|||ANCOVA|||Mean change from baseline to 1 month||9.60|2.24|0.002
72576328|NCT01775189|144679139|SUPERIORITY_OR_OTHER||LS Mean Difference|5.0||||0.3502|TWO_SIDED|95.0|-5.6|15.5||P-value was adjusted using Benjamini-Hochberg method.|Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||15.5|-5.6|0.3502
72576329|NCT01775189|144679139|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.6||||0.7624|TWO_SIDED|95.0|-12.1|8.9||P-value was adjusted using Benjamini-Hochberg method.|Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||8.9|-12.1|0.7624
72576330|NCT01775189|144679139|SUPERIORITY_OR_OTHER||LS Mean Difference|59.6|||<|0.0001|TWO_SIDED|95.0|49.0|70.1||P-value was adjusted using Benjamini-Hochberg method.|Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||70.1|49.0|<0.0001
72576331|NCT01775189|144679139|SUPERIORITY_OR_OTHER||LS Mean Difference|61.2|||<|0.0001|TWO_SIDED|95.0|50.6|71.7||P-value was adjusted using Benjamini-Hochberg method.|Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||71.7|50.6|<0.0001
72628026|NCT00271544|144784202|SUPERIORITY_OR_OTHER||One sample proportion|0.96||||||95.0|0.932|0.989||||||||0.989|0.932|
72628027|NCT00271544|144784203|SUPERIORITY_OR_OTHER||One sample mean|1.1|STANDARD_DEVIATION|0.9||||95.0|1.1|1.2|||||1-side 95% confidence limit upper bound|||1.2|1.1|
72628028|NCT00271544|144784204|SUPERIORITY_OR_OTHER||One sample mean|1.9|STANDARD_DEVIATION|2.0||||97.5|1.9|2.2|||||1-sided 97.5% confidence limit upper bound|||2.2|1.9|
72541903|NCT01735877|144613596|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.71||||0.005|TWO_SIDED|95.0|2.8|14.63|||ANCOVA|||Mean change from baseline to 3 month||14.63|2.80|0.005
72628029|NCT00271544|144784205|SUPERIORITY_OR_OTHER||One sample proportion|0.989||||||95.0|0.974|1.0||||||||1|0.974|
72541904|NCT01735877|144613596|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.63||||0.006|TWO_SIDED|95.0|2.67|14.6|||ANCOVA|||Mean change from baseline to 6 month||14.60|2.67|0.006
72541905|NCT01735877|144613597|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.64|STANDARD_ERROR_OF_MEAN|0.24||0.99|||||||t-test, 2 sided|||Baseline||||0.99
72541906|NCT01735877|144613597|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.68|||<|0.0001|TWO_SIDED|95.0|2.93|4.42|||ANCOVA|||Mean change from baseline to 1 month||4.42|2.93|<0.0001
72541907|NCT01735877|144613597|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.41|||<|0.0001|TWO_SIDED|95.0|2.61|4.21|||ANCOVA|||Mean change from baseline to 3 month||4.21|2.61|<0.0001
72541908|NCT01735877|144613597|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.21|||<|0.0001|TWO_SIDED|95.0|2.4|4.02|||ANCOVA|||Mean change from baseline to 6 month||4.02|2.40|<0.0001
72541909|NCT01735877|144613598|SUPERIORITY_OR_OTHER|||||||0.99|||||||Chi-squared|||At Baseline||||0.99
72541910|NCT01735877|144613598|SUPERIORITY_OR_OTHER|||||||0.99|||||||Chi-squared|||At month 1||||0.99
72541911|NCT01735877|144613598|SUPERIORITY_OR_OTHER|||||||0.04|||||||Chi-squared|||At month 3||||0.04
72541912|NCT01735877|144613598|SUPERIORITY_OR_OTHER|||||||0.01|||||||Chi-squared|||At month 6||||0.01
72541913|NCT00331773|144613669|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|This trial was designed to establish with 90% power and a two-sided significance level of 0.05 that Arm 2 (Hypofractionated 3D-CRT) results in a 5-year DFS that is not lower than Arm 1 by more than 7.65% (hazard ratio \[HR\] , 1.52). Patients analyzed according to assignment, with time-to event duration originating at random assignment. DFS distributions calculated using the Kaplan-Meier method. Treatment efficacy for DFS was tested by comparing cause-specific hazards with the log-rank statistic.|Hazard Ratio (HR)|0.85|||<|0.001|TWO_SIDED|95.0|0.64|1.14|||Log Rank||Reference arm = Conventional 3D-CRT|||1.14|0.64|<0.001
72576332|NCT01775189|144679140|SUPERIORITY_OR_OTHER||LS Mean Difference|24.5|||<|0.0001|TWO_SIDED|95.0|13.8|35.3||P-value was adjusted using Benjamini-Hochberg method.|Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||35.3|13.8|<0.0001
72628030|NCT00271544|144784206|SUPERIORITY_OR_OTHER||One sample proportion|0.973||||||95.0|0.95|0.996||||||||0.996|0.950|
72628031|NCT00271544|144784207|SUPERIORITY_OR_OTHER||One sample proportion|0.973||||||95.0|0.95|0.996||||||||0.996|0.950|
72628032|NCT03358030|144784221|OTHER||||||<|0.05|||||||ANOVA|||Day 12 through Day 260||||<0.05
72628033|NCT03358030|144784221|OTHER||||||<|0.05|||||||ANOVA|||Day 15 through Day 232||||<0.05
72628034|NCT03358030|144784222|OTHER||||||<|0.05|||||||Wilcoxon Rank Sum Test|Wilcoxon Rank Sum Test based on t approximation||Day 15 through Day 176||||< 0.05
72628035|NCT03358030|144784222|OTHER||||||<|0.05|||||||Wilcoxon Rank Sum Test|Wilcoxon Rank Sum Test based on t approximation||Day 12 through Day 176||||< 0.05
72576333|NCT01775189|144679140|SUPERIORITY_OR_OTHER||LS Mean Difference|-61.7|||<|0.0001|TWO_SIDED|95.0|-72.6|-50.9||P-value was adjusted using Benjamini-Hochberg method.|Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-50.9|-72.6|<0.0001
72576334|NCT01775189|144679140|SUPERIORITY_OR_OTHER||LS Mean Difference|18.2||||0.0012|TWO_SIDED|95.0|7.4|29.1||P-value was adjusted using Benjamini-Hochberg method.|Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||29.1|7.4|0.0012
72576335|NCT01775189|144679140|SUPERIORITY_OR_OTHER||LS Mean Difference|-6.3||||0.2507|TWO_SIDED|95.0|-17.2|4.5||P-value was adjusted using Benjamini-Hochberg method.|Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||4.5|-17.2|0.2507
72576336|NCT01775189|144679140|SUPERIORITY_OR_OTHER||LS Mean Difference|79.9|||<|0.0001|TWO_SIDED|95.0|69.2|90.7||P-value was adjusted using Benjamini-Hochberg method.|Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||90.7|69.2|<0.0001
72576337|NCT01775189|144679140|SUPERIORITY_OR_OTHER||LS Mean Difference|86.3|||<|0.0001|TWO_SIDED|95.0|75.4|97.1||P-value was adjusted using Benjamini-Hochberg method.|Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||97.1|75.4|<0.0001
72576338|NCT01775189|144679141|SUPERIORITY_OR_OTHER||LS Mean Difference|26.9||||0.0015|TWO_SIDED|95.0|10.6|43.1||P-value was adjusted using Benjamini-Hochberg method.|Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||43.1|10.6|0.0015
72576339|NCT01775189|144679141|SUPERIORITY_OR_OTHER||LS Mean Difference|-109.3|||<|0.0001|TWO_SIDED|95.0|-125.7|-93.0||P-value was adjusted using Benjamini-Hochberg method.|Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-93.0|-125.7|<0.0001
72628036|NCT00829244|144784227|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.7|STANDARD_ERROR_OF_MEAN|0.8||0.037|TWO_SIDED|95.0|-3.3|-0.1|||ANOVA|||The null hypothesis was that the difference between the mean number of oocytes \[CONSORT calculator dosing - Standard dosing\] was less than or equal to \[=\<\] (-3). The alternate hypothesis was that the difference was greater than \[\>\] (-3).||-0.1|-3.3|0.037
72628037|NCT00829244|144784228|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-511.37|STANDARD_ERROR_OF_MEAN|64.52|<|0.001|TWO_SIDED|95.0|-638.78|-383.96|||ANOVA|||||-383.96|-638.78|<0.001
72576340|NCT01775189|144679141|SUPERIORITY_OR_OTHER||LS Mean Difference|21.4||||0.0109|TWO_SIDED|95.0|5.1|37.8||P-value was adjusted using Benjamini-Hochberg method.|Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||37.8|5.1|0.0109
72576341|NCT01775189|144679141|SUPERIORITY_OR_OTHER||LS Mean Difference|-5.4||||0.5117|TWO_SIDED|95.0|-21.8|10.9||P-value was adjusted using Benjamini-Hochberg method.|Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||10.9|-21.8|0.5117
72576342|NCT01775189|144679141|SUPERIORITY_OR_OTHER||LS Mean Difference|130.8|||<|0.0001|TWO_SIDED|95.0|114.5|147.0||P-value was adjusted using Benjamini-Hochberg method.|Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||147.0|114.5|<0.0001
72576343|NCT01775189|144679141|SUPERIORITY_OR_OTHER||LS Mean Difference|136.2|||<|0.0001|TWO_SIDED|95.0|119.8|152.5||P-value was adjusted using Benjamini-Hochberg method.|Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||152.5|119.8|<0.0001
72576344|NCT00856375|144679196|OTHER|Hazard Ratio and 95% CI from univariate Cox regression model|Hazard Ratio (HR)|0.645|||=|0.07|TWO_SIDED|95.0|0.4|1.041|||Log Rank|||||1.041|0.4|= 0.07
72576345|NCT00856375|144679197|OTHER|Hazard ratio and 95% CI from univariate Cox regression model.|Hazard Ratio (HR)|0.91|||=|0.706|TWO_SIDED|95.0|0.557|1.486|||Log Rank|||||1.486|0.557|= 0.706
72576346|NCT00856375|144679198|OTHER|ORR 95% CI based on Exact (Clopper-Pearson) confidence limits. Odds ratio 95% CI based on asymptotic confidence limits.|Odds Ratio (OR)|2.054|||=|0.676|TWO_SIDED|95.0|0.355|11.9|||Fisher Exact|||||11.9|0.355|= 0.676
72576347|NCT00856375|144679199|SUPERIORITY||||||=|0.018|||||||Log Rank|||||||= 0.018
72576348|NCT02597127|144679212|SUPERIORITY|Two sample t-tests were performed to test the superiority of any dosing group over placebo. A Dunnett multiple t-test procedure was applied to adjust for multiple comparisons with six different dosing regimens.|||||<|0.0001||||||This P-Value applies to the comparison of the mean percent change at Day 180 for the 200 mg (Single-Dose) Inclisiran group versus Placebo (Single-Dose).|t-test, 1 sided|||||||<0.0001
72576349|NCT02597127|144679212|SUPERIORITY|Two sample t-tests were performed to test the superiority of any dosing group over placebo. A Dunnett multiple t-test procedure was applied to adjust for multiple comparisons with six different dosing regimens.|||||<|0.0001||||||This P-Value applies to the comparison of the mean percent change at Day 180 for the 300 mg (Single-Dose) Inclisiran group versus Placebo (Single-Dose).|t-test, 1 sided|||||||<0.0001
72576350|NCT02597127|144679212|SUPERIORITY|Two sample t-tests were performed to test the superiority of any dosing group over placebo. A Dunnett multiple t-test procedure was applied to adjust for multiple comparisons with six different dosing regimens.|||||<|0.0001||||||This P-Value applies to the comparison of the mean percent change at Day 180 for the 500 mg (Single-Dose) Inclisiran group versus Placebo (Single-Dose).|t-test, 1 sided|||||||<0.0001
72576351|NCT02597127|144679212|SUPERIORITY|Two sample t-tests were performed to test the superiority of any dosing group over placebo. A Dunnett multiple t-test procedure was applied to adjust for multiple comparisons with six different dosing regimens.|||||<|0.0001||||||This P-Value applies to the comparison of the mean percent change at Day 180 for the 100 mg Double-Dose) Inclisiran group versus Placebo (Double-Dose).|t-test, 1 sided|||||||<0.0001
72628038|NCT00829244|144784229|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-45.6|STANDARD_ERROR_OF_MEAN|4.12|<|0.001|TWO_SIDED|95.0|-53.75|-37.46|||ANOVA|||||-37.46|-53.75|<0.001
72628039|NCT00829244|144784230|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.2||0.933|TWO_SIDED|95.0|-0.4|0.5|||ANOVA|||||0.5|-0.4|0.933
72541914|NCT00331773|144613672|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Patients who died without biochemical failure were considered as competing risk at the time of death. Patients alive without biochemical failure at last follow-up were censored at that date. Estimates were calculated using cumulative risk and non-inferiority was assessed against a HR of 1.67. The log-rank test was used with a two-sided p-value of 0.05.|Hazard Ratio (HR)|0.77|||<|0.001|TWO_SIDED|95.0|0.51|1.17|||Log Rank||Reference arm = Conventional 3D-CRT|||1.17|0.51|< 0.001
72541915|NCT00331773|144613673|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was assessed against a HR of 1.54, translated from a 5% difference in overall survival with 90% overall survival in the Conventional 3D-CRT arm. The log-rank test was used with a two-sided p-value of 0.05.|Hazard Ratio (HR)|0.95||||0.008|TWO_SIDED|95.0|0.64|1.41|||Log Rank||Reference arm = Conventional 3D-CRT|||1.41|0.64|0.008
72576352|NCT02597127|144679212|SUPERIORITY|Two sample t-tests were performed to test the superiority of any dosing group over placebo. A Dunnett multiple t-test procedure was applied to adjust for multiple comparisons with six different dosing regimens.|||||<|0.0001||||||This P-Value applies to the comparison of the mean percent change at Day 180 for the 200 mg Double-Dose) Inclisiran group versus Placebo (Double-Dose).|t-test, 1 sided|||||||<0.0001
72576353|NCT02597127|144679212|SUPERIORITY|Two sample t-tests were performed to test the superiority of any dosing group over placebo. A Dunnett multiple t-test procedure was applied to adjust for multiple comparisons with six different dosing regimens.|||||<|0.0001||||||This P-Value applies to the comparison of the mean percent change at Day 180 for the 300 mg Double-Dose) Inclisiran group versus Placebo (Double-Dose).|t-test, 1 sided|||||||<0.0001
72576354|NCT02922738|144679222|SUPERIORITY||Cox Proportional Hazard|0.92||||0.54|TWO_SIDED|95.0|0.7|1.21|||Regression, Cox|||||1.21|0.70|0.54
72576355|NCT02922738|144679223|SUPERIORITY|||||||0.29|||||||Wilcoxon (Mann-Whitney)|||||||0.29
72576356|NCT00811928|144679235|NON_INFERIORITY_OR_EQUIVALENCE|The upper limit of the 95% Confidence Interval for the difference in incidence defined as (# of participants affected with proven or probable IFI/ # of participants in the FAS population at risk)\*100% (posaconazole minus fluconazole) had to be \< 4 in order to be considered non-inferior. IFI occurred: proven+probable|Difference for the incidence|-5.88|||||TWO_SIDED|95.0|-12.21|0.25|||||Posaconazole minus fluconazole|||0.25|-12.21|
72576357|NCT00811928|144679236|SUPERIORITY_OR_OTHER||Percentage of Participants|4.27|||||TWO_SIDED|95.0|1.4|9.7|||||IFI Incidence for the Posaconazole group = (# of participants affected with proven or probable IFI/ # of participants in the FAS population at risk)\*100%|||9.7|1.4|
72576358|NCT00811928|144679236|SUPERIORITY_OR_OTHER||Percentage of Participants|13.68|||||TWO_SIDED|95.0|8.0|21.3|||||IFI Incidence for the Fluconazole group = (# of participants affected with proven or probable IFI/ # of participants in the FAS population at risk)\*100%|||21.3|8.0|
72541916|NCT00331773|144613674|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|1.03||||0.85|TWO_SIDED|95.0|0.73|1.46||2-sided|Regression, Logistic||Reference arm = Conventional 3D-CRT|Acute GI toxicity rates were tabulated and dichotomized as \< grade 2 vs ≥ grade 2. To evaluate the differences by treatment arm, 2 X 2 subtables were formed and relative risk (RR) estimates with 95% confidence intervals (CIs) were computed.||1.46|0.73|0.85
72576359|NCT00811928|144679239|SUPERIORITY_OR_OTHER||Percentage of Participants|31.62|||||TWO_SIDED|95.0|23.3|40.9|||||IFI Incidence for the Posaconazole group = (# of participants affected with proven or probable IFI/ # of participants in the FAS population at risk)\*100%.|||40.9|23.3|
72576360|NCT00811928|144679239|SUPERIORITY_OR_OTHER||Percentage of Participants|41.88|||||TWO_SIDED|95.0|32.8|51.4|||||IFI Incidence for the Fluconazole group = (# of participants affected with proven or probable IFI/ # of participants in the FAS population at risk)\*100%|||51.4|32.8|
72576361|NCT00811928|144679240|SUPERIORITY_OR_OTHER||Percentage of Participants|2.56|||||TWO_SIDED|95.0|0.5|7.3|||||All-Cause Mortality Rate is the percentage of participants with mortality from any cause.|||7.3|0.5|
72576362|NCT00811928|144679240|SUPERIORITY_OR_OTHER||Percentage of Participants|5.98|||||TWO_SIDED|95.0|2.4|11.9|||||All-Cause Mortality Rate is the percentage of participants with mortality from any cause.|||11.9|2.4|
72576363|NCT04181723|144679262|SUPERIORITY||LSM difference|-3.1|STANDARD_ERROR_OF_MEAN|1.3||0.0175|TWO_SIDED|95.0|-5.7|-0.6|||Mixed-effects model for repeated measure|||||-0.6|-5.7|0.0175
72576364|NCT04181723|144679263|SUPERIORITY||LSM difference|-0.3|STANDARD_ERROR_OF_MEAN|0.1||0.003|TWO_SIDED|95.0|-0.5|-0.1|||Mixed-effects model for repeated measure|||||-0.1|-0.5|0.0030
72576365|NCT04181723|144679264|SUPERIORITY||LSM difference|1.0|STANDARD_ERROR_OF_MEAN|0.37||0.0064|TWO_SIDED|95.0|0.3|1.7|||Mixed-effects model for repeated measure|||||1.7|0.3|0.0064
72628040|NCT00829244|144784232|SUPERIORITY_OR_OTHER||Percent difference|3.6|||||TWO_SIDED|95.0|-11.0|18.2||||||||18.2|-11.0|
72576366|NCT04181723|144679265|SUPERIORITY||LSM difference|-4.5|STANDARD_ERROR_OF_MEAN|4.67||0.3376|TWO_SIDED|95.0|-13.8|4.8|||ANCOVA|||||4.8|-13.8|0.3376
72576367|NCT04181723|144679266|SUPERIORITY||LSM difference|-0.1|STANDARD_ERROR_OF_MEAN|0.11||0.3649|TWO_SIDED|95.0|-0.3|0.1|||Mixed-effects model for repeated measure|||||0.1|-0.3|0.3649
72576368|NCT04181723|144679267|SUPERIORITY||LSM difference|-0.1|STANDARD_ERROR_OF_MEAN|0.1||0.2114|TWO_SIDED|95.0|-0.3|0.1|||Mixed-effects model for repeated measure|||||0.1|-0.3|0.2114
72576369|NCT04181723|144679268|SUPERIORITY||LSM difference|-0.3|STANDARD_ERROR_OF_MEAN|0.15||0.0257|TWO_SIDED|95.0|-0.6|0.0|||Mixed-effects model for repeated measure|||||0.0|-0.6|0.0257
72576370|NCT04181723|144679269|SUPERIORITY||LSM difference|0.0|STANDARD_ERROR_OF_MEAN|0.08||0.9799|TWO_SIDED|95.0|-0.2|0.2|||Mixed-effects model for repeated measure|||||0.2|-0.2|0.9799
72576371|NCT04181723|144679270|SUPERIORITY||LSM difference|0.0|STANDARD_ERROR_OF_MEAN|0.05||0.5304|TWO_SIDED|95.0|-0.1|0.1|||Mixed-effects model for repeated measure|||||0.1|-0.1|0.5304
72576372|NCT04181723|144679271|SUPERIORITY||LSM difference|-0.8|STANDARD_ERROR_OF_MEAN|1.4||0.5855|TWO_SIDED|95.0|-3.5|2.0|||ANCOVA|||||2.0|-3.5|0.5855
72576373|NCT04181723|144679272|SUPERIORITY||LSM difference|0.1|STANDARD_ERROR_OF_MEAN|0.13||0.2507|TWO_SIDED|95.0|-0.1|0.4|||Mixed-effects model for repeated measure|||||0.4|-0.1|0.2507
72628041|NCT00829244|144784234|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.6|STANDARD_ERROR_OF_MEAN|6.6||0.926|TWO_SIDED|95.0|-12.3|13.6|||ANOVA|||||13.6|-12.3|0.926
72628042|NCT00829244|144784236|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.93|STANDARD_ERROR_OF_MEAN|0.78||0.235|TWO_SIDED|95.0|-0.61|2.47|||ANOVA|||||2.47|-0.61|0.235
72628043|NCT00829244|144784237|SUPERIORITY_OR_OTHER||Percent difference|0.6|||||TWO_SIDED|95.0|-13.5|14.6||||||||14.6|-13.5|
72541917|NCT00331773|144613674|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|1.31||||0.72|TWO_SIDED|95.0|0.29|5.81||2-sided|Regression, Logistic||Reference arm = Conventional 3D-CRT|Acute GI toxicity rates were tabulated and dichotomized as \< grade 3 vs ≥ grade 3. To evaluate the differences by treatment arm, 2 X 2 subtables were formed and relative risk (RR) estimates with 95% CIs were computed.||5.81|0.29|0.72
72541918|NCT00331773|144613674|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.99||||0.95|TWO_SIDED|95.0|0.82|1.21||2-sided|Regression, Logistic||Reference Arm = Conventional 3D-CRT|Acute GU toxicity rates were tabulated and dichotomized as \< grade 2 vs ≥ grade 2. To evaluate the differences by treatment arm, 2 X 2 subtables were formed and relative risk (RR) estimates with 95% CIs were computed.||1.21|0.82|0.95
72541919|NCT00331773|144613674|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|1.36||||0.39|TWO_SIDED|95.0|0.67|2.74||2-sided|Regression, Logistic||Reference arm = Conventional 3D-CRT|Acute GU toxicity rates were tabulated and dichotomized as \< grade 3 vs ≥ grade 3. To evaluate the differences by treatment arm, 2 X 2 subtables were formed and relative risk (RR) estimates with 95% CIs were computed.||2.74|0.67|0.39
72541920|NCT00331773|144613674|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|1.59||||0.005|TWO_SIDED|95.0|1.22|2.06||2-sided|Regression, Logistic||Reference arm = Conventional 3D-CRT|Late GI toxicity rates were tabulated and dichotomized as \< grade 2 vs ≥ grade 2. To evaluate the differences by treatment arm, 2 X 2 subtables were formed and relative risk (RR) estimates with 95% CIs were computed.||2.06|1.22|0.005
72541921|NCT00331773|144613674|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|1.55||||0.19|TWO_SIDED|95.0|0.8|2.99||2-sided|Regression, Logistic||Reference arm = Conventional 3D-CRT|Late GI toxicity rates were tabulated and dichotomized as \< grade 3 vs ≥ grade 3. To evaluate the differences by treatment arm, 2 X 2 subtables were formed and relative risk (RR) estimates with 95% CIs were computed.||2.99|0.80|0.19
72576374|NCT03203564|144679276|OTHER||Mean Difference (Final Values)|7.4|||||TWO_SIDED|90.0|0.68|14.12|||||Parameter estimate is done for Placebo-corrected change-from baseline QTcF (ΔΔQTcF) for Modufolin 500 mg/m2 at end of infusion.|"The primary analysis of QTcF was based on a linear mixed-effects model with change-from-baseline QTcF as the dependent variable, time (categorical), treatment, and time-by-treatment interaction as fixed effects, and baseline QTcF as a covariate. The least-squares (LS) mean and 2-sided 90 % CIs have been calculated for the contrast Modufolin® versus placebo at each dose of Modufolin® and each post-dose time point."||14.12|0.68|
72576375|NCT04630158|144679307|SUPERIORITY||Least Square (LS) mean difference|1.6|STANDARD_ERROR_OF_MEAN|5.1||0.93|TWO_SIDED|95.0|-8.5|11.7||Reporting the adjusted p-value derived based on Dunett procedure.|Mixed Models Analysis|mixed-model repeated measures (MMRM) analysis||||11.7|-8.5|0.930
72576376|NCT04630158|144679307|SUPERIORITY||Least Square (LS) mean difference|3.7|STANDARD_ERROR_OF_MEAN|5.11||0.699|TWO_SIDED|95.0|-6.4|13.8||Reporting the adjusted p-value derived based on Dunett procedure.|Mixed Models Analysis|mixed-model repeated measures (MMRM) analysis||||13.8|-6.4|0.699
72576377|NCT05162014|144679324|OTHER||Hazard Ratio (HR)|0.88|||||TWO_SIDED|95.0|0.76|1.02|||Regression, Cox|Cox proportional hazards regression models based on time-to-first acute pancreatitis used to estimate the hazard ratios.||||1.02|0.76|
72576378|NCT03496610|144679363|SUPERIORITY|||||||0.81|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum test performed given non-normal distribution of data by Shapiro Wilks Test. Null hypothesis is that there is no difference in oral morphine equivalent consumption between the two groups in the first 24hrs after surgery. Original sample size calculation based on α=0.05, β=0.8, difference in means=2, and effect size of 1.0.||||0.81
72576379|NCT03496610|144679364|SUPERIORITY|||||||0.4|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum test performed with α=0.05. The null hypothesis is that there is no difference between the two groups in pain on postoperative day 7.||||0.40
72576380|NCT03496610|144679365|SUPERIORITY|||||||0.74|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum test performed with α=0.05. The null hypothesis is that there is no difference in bloating severity between the two groups.||||0.74
72576381|NCT03496610|144679366|OTHER|||||||0.38|||||||Chi-squared|Degrees of freedom = 1||Compared using the Likelihood ratio test with α=0.05. The null hypothesis was that there is no difference between the groups.||||0.38
72576382|NCT02714426|144679367|OTHER|||||||0.024||||||A priori threshold for statistical significance was set at p \< .05. No adjustment was made for multiple comparisons. The critical effect of interest evaluated here was the Linear Occasion (1-14) x Group (Brain Health vs. Mindfulness) interaction.|Mixed Models Analysis|F(1,33) = 5.57, p = .024, no adjustments.||Mixed effects models were used. Independent variables were linear and quadratic time/occasion, intervention group, and group-by-time interactions if appropriate. Preparatory to modeling, preliminary unconditional models were run to determine best fitting approaches for repeated and random covariance structures. First-order Autoregressive was best (which specifies homogeneous variance over time but allows one correlation between occasions).||||.024
72576383|NCT02714426|144679368|OTHER|||||||0.333||||||A priori threshold for statistical significance was set at p \< .05. No adjustment was made for multiple comparisons. The critical effect of interest evaluated here was the Linear Occasion (1-14) x Group (Brain Health vs. Mindfulness) interaction.|Mixed Models Analysis|F(1,34) = 0.96, p = .333, no adjustments.||Mixed effects models were used. Independent variables were linear and quadratic time/occasion, intervention group, and group-by-time interactions if appropriate. Preparatory to modeling, preliminary unconditional models were run to determine best fitting approaches for repeated and random covariance structures. Diagonal repeated covariance was best (heterogeneous variance over time, and no residual cross-time covariances).||||0.333
72576384|NCT02714426|144679370|OTHER|||||||0.001||||||A priori threshold for statistical significance was set at p \< .05. No adjustment was made for multiple comparisons. The critical effect of interest evaluated here was the Linear Occasion (1-8) x Group (Brain Health vs. Mindfulness) interaction.|Mixed Models Analysis|F(1,31.069) = 15.046, p = .001, no adjustments.||Mixed effects models were used. Independent variables were linear and quadratic time/occasion, intervention group, and group-by-time interactions if appropriate. Preparatory to modeling, preliminary unconditional models were run to determine best fitting approaches for repeated and random covariance structures. Diagonal repeated covariance was best (heterogeneous variance over time, and no residual cross-time covariances).||||0.001
72628044|NCT02297412|144784279|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0186|||||||Wilcoxon (Mann-Whitney)|||||||0.0186
72628045|NCT02297412|144784280|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1146|||||||Wilcoxon (Mann-Whitney)|||||||0.1146
72628046|NCT02297412|144784281|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0243|||||||Wilcoxon (Mann-Whitney)|||||||0.0243
72541922|NCT00331773|144613674|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|1.31||||0.009|TWO_SIDED|95.0|1.07|1.61||2-sided|Regression, Logistic||Reference arm = Conventional 3D-CRT|Late GU toxicity rates were tabulated and dichotomized as \< grade 2 vs ≥ grade 2. To evaluate the differences by treatment arm, 2 X 2 subtables were formed and relative risk (RR) estimates with 95% CIs were computed.||1.61|1.07|0.009
72541923|NCT00331773|144613674|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|1.56||||0.22|TWO_SIDED|95.0|0.76|3.18||2-sided|Regression, Logistic||Reference arm = Conventional 3D-CRT|Late GU toxicity rates were tabulated and dichotomized as \< grade 3 vs ≥ grade 3. To evaluate the differences by treatment arm, 2 X 2 subtables were formed and relative risk (RR) estimates with 95% CIs were computed.||3.18|0.76|0.22
72541924|NCT00331773|144613675|SUPERIORITY_OR_OTHER_LEGACY|||||||0.72|||||||Wilcoxon (Mann-Whitney)|||EPIC Bowel Domain at 6 months||||0.72
72541925|NCT00331773|144613675|SUPERIORITY_OR_OTHER_LEGACY|||||||0.056|||||||Wilcoxon (Mann-Whitney)|||EPIC Urinary Domain at 6 months||||0.056
72541926|NCT00331773|144613675|SUPERIORITY_OR_OTHER_LEGACY|||||||0.99|||||||Wilcoxon (Mann-Whitney)|||EPIC Sexual Domain at 6 months||||0.99
72541927|NCT00331773|144613675|SUPERIORITY_OR_OTHER_LEGACY|||||||0.49|||||||Wilcoxon (Mann-Whitney)|||EPIC Hormonal Domain at 6 months||||0.49
72541928|NCT00331773|144613675|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0037|||||||Wilcoxon (Mann-Whitney)|||EPIC Bowel Domain at 12 months||||0.0037
72541929|NCT00331773|144613675|SUPERIORITY_OR_OTHER_LEGACY|||||||0.062|||||||Wilcoxon (Mann-Whitney)|||EPIC Urinary Domain at 12 months||||0.062
72541930|NCT00331773|144613675|SUPERIORITY_OR_OTHER_LEGACY|||||||0.94|||||||Wilcoxon (Mann-Whitney)|||EPIC Sexual Domain at 12 months||||0.94
72541931|NCT00331773|144613675|SUPERIORITY_OR_OTHER_LEGACY|||||||0.93|||||||Wilcoxon (Mann-Whitney)|||EPIC Hormonal Domain at 12 months||||0.93
72541932|NCT00331773|144613675|SUPERIORITY_OR_OTHER_LEGACY|||||||0.12|||||||Wilcoxon (Mann-Whitney)|||EPIC Bowel Domain at 24 months||||0.12
72541933|NCT00331773|144613675|SUPERIORITY_OR_OTHER_LEGACY|||||||0.81|||||||Wilcoxon (Mann-Whitney)|||EPIC Urinary Domain at 24 months||||0.81
72541934|NCT00331773|144613675|SUPERIORITY_OR_OTHER_LEGACY|||||||0.69|||||||Wilcoxon (Mann-Whitney)|||EPIC Sexual Domain at 24 months||||0.69
72541935|NCT00331773|144613675|SUPERIORITY_OR_OTHER_LEGACY|||||||0.68|||||||Wilcoxon (Mann-Whitney)|||EPIC Hormonal Domain at 24 months||||0.68
72541936|NCT00331773|144613675|SUPERIORITY_OR_OTHER_LEGACY|||||||0.071|||||||Wilcoxon (Mann-Whitney)|||EPIC Bowel Domain at 60 months||||0.071
72541937|NCT00331773|144613675|SUPERIORITY_OR_OTHER_LEGACY|||||||0.047|||||||Wilcoxon (Mann-Whitney)|||EPIC Urinary Domain at 60 months||||0.047
72576385|NCT02714426|144679371|OTHER|||||||0.448||||||A priori threshold for statistical significance was set at p \< .05. No adjustment was made for multiple comparisons. The critical effect of interest evaluated here was the Linear Occasion (1-14) x Group (Brain Health vs. Mindfulness) interaction.|Mixed Models Analysis|F(1,34) = 0.589, p = .0.448, no adjustments.||Mixed effects models were used. Independent variables were linear and quadratic time/occasion, intervention group, and group-by-time interactions if appropriate. Preparatory to modeling, preliminary unconditional models were run to determine best fitting approaches for repeated and random covariance structures. Diagonal repeated covariance was best (heterogeneous variance over time, and no residual cross-time covariances).||||0.448
72541938|NCT00331773|144613675|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4|||||||Wilcoxon (Mann-Whitney)|||EPIC Sexual Domain at 60 months||||0.4
72576822|NCT00261443|144680657|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.11||||0.305|TWO_SIDED|95.0|-0.31|0.1||Baseline: ANOVA model, controlling for treatment, mood stabilizer, and index mood episode. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 16 Comparison||0.10|-0.31|0.305
72541939|NCT00331773|144613675|SUPERIORITY_OR_OTHER_LEGACY|||||||0.91|||||||Wilcoxon (Mann-Whitney)|||EPIC Hormonal Domain at 60 months||||0.91
72541940|NCT00331773|144613677|SUPERIORITY_OR_OTHER_LEGACY|||||||0.55|||||||Wilcoxon (Mann-Whitney)|||The distribution of HSCL-25 at 6 months was calculated, and Wilcoxon test statistics were used to test the null hypothesis that responses are the same across the two treatment arms versus the alternative hypothesis that they are different. Significance level = 0.0125, two-sided test.||||0.55
72541941|NCT00331773|144613677|SUPERIORITY_OR_OTHER_LEGACY|||||||0.29|||||||Wilcoxon (Mann-Whitney)|||The distribution of HSCL-25 at 12 months was calculated, and Wilcoxon test statistics were used to test the null hypothesis that responses are the same across the two treatment arms versus the alternative hypothesis that they are different. Significance level = 0.0125, two-sided test.||||0.29
72541942|NCT00331773|144613677|SUPERIORITY_OR_OTHER_LEGACY|||||||0.23|||||||Wilcoxon (Mann-Whitney)|||The distribution of HSCL-25 at 24 months was calculated, and Wilcoxon test statistics were used to test the null hypothesis that responses are the same across the two treatment arms versus the alternative hypothesis that they are different. Significance level = 0.0125, two-sided test.||||0.23
72541943|NCT00331773|144613677|SUPERIORITY_OR_OTHER_LEGACY|||||||0.028|||||||Wilcoxon (Mann-Whitney)|||The distribution of HSCL-25 at 60 months (5 years) was calculated, and Wilcoxon test statistics were used to test the null hypothesis that responses are the same across the two treatment arms versus the alternative hypothesis that they are different. Significance level = 0.0125, two-sided test.||||0.028
72541944|NCT00331773|144613678|SUPERIORITY_OR_OTHER_LEGACY|||||||0.037|||||||Wilcoxon (Mann-Whitney)|Two-sided significance level = 0.05||Baseline VAS score||||0.037
72541945|NCT00331773|144613678|SUPERIORITY_OR_OTHER_LEGACY|||||||0.12||||||Two-sided significance level = 0.05|Wilcoxon (Mann-Whitney)|||Baseline index score||||0.12
72541946|NCT00331773|144613678|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7||||||Two-sided significance level = 0.05|Wilcoxon (Mann-Whitney)|||6-month VAS score||||0.70
72541947|NCT00331773|144613678|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2||||||Two-sided significance level = 0.05|Wilcoxon (Mann-Whitney)|||6-month index score||||0.20
72541948|NCT00331773|144613678|SUPERIORITY_OR_OTHER_LEGACY|||||||0.31||||||Two-sided significance level = 0.05|Wilcoxon (Mann-Whitney)|||12-month VAS score||||0.31
72541949|NCT00331773|144613678|SUPERIORITY_OR_OTHER_LEGACY|||||||0.19||||||Two-sided significance level = 0.05|Wilcoxon (Mann-Whitney)|||12-month index score||||0.19
72541950|NCT00331773|144613678|SUPERIORITY_OR_OTHER_LEGACY|||||||0.86||||||Two-sided significance level = 0.05|Wilcoxon (Mann-Whitney)|||24-month VAS score||||0.86
72541951|NCT00331773|144613678|SUPERIORITY_OR_OTHER_LEGACY|||||||0.45||||||Two-sided significance level = 0.05|Wilcoxon (Mann-Whitney)|||24-month index score||||0.45
72541952|NCT00331773|144613678|SUPERIORITY_OR_OTHER_LEGACY|||||||0.39||||||Two-sided significance level = 0.05|Wilcoxon (Mann-Whitney)|||60-month VAS score||||0.39
72541953|NCT00331773|144613678|SUPERIORITY_OR_OTHER_LEGACY|||||||0.56||||||Two-sided significance level = 0.05|Wilcoxon (Mann-Whitney)|||60-month index score||||0.56
72541954|NCT00661674|144613697|SUPERIORITY_OR_OTHER|||||||0.0001||||||p-value represents comparison between OOWS scores at T=180 and the baseline measurements at T=-30.|Friedman Test|||"Null Hypothesis: There will be no difference in OOWS scores when comparing treatment groups (Palonosetron \& Palonosetron + Hydroxyzine) with placebo.~Analysis of the data obtained in our prior study indicated that analysis of 10 individuals would provide 90% power to detect a treatment effect. Therefore, we examined the effect of three different pretreatments on naloxone-induced opiate withdrawal signs in 10 healthy individuals."||||0.0001
72541955|NCT00661674|144613698|SUPERIORITY_OR_OTHER|||||||0.2244||||||p-value represents comparison between SOWS scores at T=180 and the baseline measurements at T=-30.|Friedman Test|||"Null Hypothesis: There will be no difference in SOWS scores when comparing the 2 treatment groups (Palonosetron \& Palonosetron + Hydroxyzine) with placebo.~Analysis of the data obtained in our prior study indicated that analysis of 10 individuals would provide 90% power to detect a treatment effect. Therefore, we examined the effect of three different pretreatments on naloxone-induced opiate withdrawal signs in 10 healthy individuals."||||0.2244
72541956|NCT01872689|144613699|SUPERIORITY||Median Difference (Final Values)|0.98111|STANDARD_ERROR_OF_MEAN|1.31064||0.4555|TWO_SIDED|95.0|-1.61|3.57|||Mixed Models Analysis|||Mixed Linear model comparing Lebrikizumab to Placebo, with assessment as the outcome variable; assessment time by treatment as fixed effects; and participant baseline FVC (\<50%, 50 to 75%, \>75%) and participant by assessment time as random effects with unstructured covariance.||3.57|-1.61|0.4555
72541957|NCT01872689|144613699|SUPERIORITY||Mean Difference (Final Values)|0.49998|STANDARD_ERROR_OF_MEAN|0.84946||0.5566|TWO_SIDED|95.0|-1.17|2.17|||Mixed Models Analysis|||Mixed Linear model comparing Lebrikizumab to Placebo, with assessment as the outcome variable; assessment time by treatment as fixed effects; and participant baseline FVC (\<50%, 50 to 75%, \>75%) and participant by assessment time as random effects with unstructured covariance.||2.17|-1.17|0.5566
72541958|NCT01872689|144613700|SUPERIORITY||Median Difference (Final Values)|21.93023|STANDARD_ERROR_OF_MEAN|21.62248||0.3129|TWO_SIDED|95.0|-20.97|64.83|||Mixed Models Analysis|||Mixed Linear model comparing Lebrikizumab to Placebo, with assessment as the outcome variable; assessment time by treatment as fixed effects; and participant baseline FVC (\<50%, 50 to 75%, \>75%) and participant by assessment time as random effects with unstructured covariance.||64.83|-20.97|0.3129
72541959|NCT01872689|144613700|SUPERIORITY||Mean Difference (Final Values)|-21.4127|STANDARD_ERROR_OF_MEAN|16.8016||0.2036|TWO_SIDED|95.0|-54.5|11.67|||Mixed Models Analysis|||Mixed Linear model comparing Lebrikizumab to Placebo, with assessment as the outcome variable; assessment time by treatment as fixed effects; and participant baseline FVC (\<50%, 50 to 75%, \>75%) and participant by assessment time as random effects with unstructured covariance.||11.67|-54.50|0.2036
72541960|NCT01872689|144613702|SUPERIORITY||Hazard Ratio (HR)|0.79||||0.4299|TWO_SIDED|95.0|0.44|1.41|||Log Rank|||Stratified Analysis: stratified by baseline FVC (\<50%, 50 to 75%, \>75%)||1.41|0.44|0.4299
72541961|NCT01872689|144613702|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.3751|TWO_SIDED|95.0|0.56|1.24|||Log Rank|||Stratified Analysis: stratified by baseline FVC (\<50%, 50 to 75%, \>75%)||1.24|0.56|0.3751
72541962|NCT01872689|144613703|SUPERIORITY||Median Difference (Final Values)|0.54171|STANDARD_ERROR_OF_MEAN|1.05201||0.6075|TWO_SIDED|95.0|-1.54|2.62|||Mixed Models Analysis|||Mixed Linear model comparing Lebrikizumab to Placebo, with assessment as the outcome variable; assessment time by treatment as fixed effects; and participant baseline FVC (\<50%, 50 to 75%, \>75%) and participant by assessment time as random effects with unstructured covariance.||2.62|-1.54|0.6075
72541963|NCT01872689|144613703|SUPERIORITY||Mean Difference (Final Values)|0.18203|STANDARD_ERROR_OF_MEAN|0.65206||0.7803|TWO_SIDED|95.0|-1.1|1.47|||Mixed Models Analysis|||Mixed Linear model comparing Lebrikizumab to Placebo, with assessment as the outcome variable; assessment time by treatment as fixed effects; and participant baseline FVC (\<50%, 50 to 75%, \>75%) and participant by assessment time as random effects with unstructured covariance.||1.47|-1.10|0.7803
72541964|NCT01872689|144613705|SUPERIORITY||Hazard Ratio (HR)|0.65||||0.0972|TWO_SIDED|95.0|0.39|1.09|||Log Rank|||Stratified Analysis: stratified by baseline FVC (\<50%, 50 to 75%, \>75%)||1.09|0.39|0.0972
72541965|NCT01872689|144613705|SUPERIORITY||Hazard Ratio (HR)|1.01||||0.9344|TWO_SIDED|95.0|0.72|1.42|||Log Rank|||Stratified Analysis: stratified by baseline FVC (\<50%, 50 to 75%, \>75%)||1.42|0.72|0.9344
72541966|NCT01872689|144613706|SUPERIORITY||Median Difference (Final Values)|28.12302|STANDARD_ERROR_OF_MEAN|49.47253||0.5707|TWO_SIDED|95.0|-69.8|126.04|||Mixed Models Analysis||Mean Difference = Lebrikizumab - Placebo|Mixed Linear model comparing Lebrikizumab to Placebo, with assessment as the outcome variable; assessment time by treatment as fixed effects; and participant baseline FVC (\<50%, 50 to 75%, \>75%) and participant by assessment time as random effects with unstructured covariance.||126.04|-69.80|0.5707
72541967|NCT01872689|144613706|SUPERIORITY||Mean Difference (Final Values)|21.72972|STANDARD_ERROR_OF_MEAN|31.68767||0.4934|TWO_SIDED|95.0|-40.65|84.11|||Mixed Models Analysis||Mean Difference = Lebrikizumab - Placebo|Mixed Linear model comparing Lebrikizumab to Placebo, with assessment as the outcome variable; assessment time by treatment as fixed effects; and participant baseline FVC (\<50%, 50 to 75%, \>75%) and participant by assessment time as random effects with unstructured covariance.||84.11|-40.65|0.4934
72541968|NCT01872689|144613707|SUPERIORITY||Median Difference (Final Values)|-2.10204|STANDARD_ERROR_OF_MEAN|2.41325||0.3854|TWO_SIDED|95.0|-6.88|2.68|||Mixed Models Analysis|||Mixed Linear model comparing Lebrikizumab to Placebo, with assessment as the outcome variable; assessment time by treatment as fixed effects; and participant baseline FVC (\<50%, 50 to 75%, \>75%) and participant by assessment time as random effects with unstructured covariance.||2.68|-6.88|0.3854
72541969|NCT01872689|144613707|SUPERIORITY||Mean Difference (Final Values)|-0.16313|STANDARD_ERROR_OF_MEAN|1.37698||0.9057|TWO_SIDED|95.0|-2.87|2.55|||Mixed Models Analysis|||Mixed Linear model comparing Lebrikizumab to Placebo, with assessment as the outcome variable; assessment time by treatment as fixed effects; and participant baseline FVC (\<50%, 50 to 75%, \>75%) and participant by assessment time as random effects with unstructured covariance.||2.55|-2.87|0.9057
72541970|NCT01872689|144613709|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.4433|TWO_SIDED|95.0|0.54|1.31|||Log Rank|||Stratified Analysis: stratified by baseline FVC (\<50%, 50 to 75%, \>75%)||1.31|0.54|0.4433
72410116|NCT02447991|144328602|SUPERIORITY||||||<|0.19||||||Significance threshold p \< 0.05|Chi-squared, Corrected|This analysis applies to proportions of treated episodes||Hypothesis: Rizatriptan will be superior to placebo in reducing the severity of unsteadiness/dizziness as measured by the proportion of treated episodes in which subjects experience freedom from vestibular symptoms (i.e., severity rating of Grade 0) at 1 hour after taking study medication.||||<0.19
72541971|NCT01872689|144613711|SUPERIORITY||Hazard Ratio (HR)|1.07||||0.9366|TWO_SIDED|95.0|0.21|5.3|||Log Rank|||Stratified Analysis: stratified by baseline FVC (\<50%, 50 to 75%, \>75%)||5.30|0.21|0.9366
72541972|NCT01872689|144613711|SUPERIORITY||Hazard Ratio (HR)|0.45||||0.1346|TWO_SIDED|95.0|0.16|1.31|||Log Rank|||Stratified Analysis: stratified by baseline FVC (\<50%, 50 to 75%, \>75%)||1.31|0.16|0.1346
72541973|NCT01872689|144613713|SUPERIORITY||Hazard Ratio (HR)|0.89||||0.6815|TWO_SIDED|95.0|0.52|1.54|||Log Rank|||Stratified Analysis: stratified by baseline FVC (\<50%, 50 to 75%, \>75%)||1.54|0.52|0.6815
72541974|NCT01872689|144613715|SUPERIORITY||Hazard Ratio (HR)|0.72||||0.5685|TWO_SIDED|95.0|0.23|2.26|||Log Rank|||Stratified Analysis: stratified by baseline FVC (\<50%, 50 to 75%, \>75%)||2.26|0.23|0.5685
72541975|NCT01872689|144613715|SUPERIORITY||Hazard Ratio (HR)|0.68||||0.1976|TWO_SIDED|95.0|0.37|1.23|||Log Rank|||Stratified Analysis: stratified by baseline FVC (\<50%, 50 to 75%, \>75%)||1.23|0.37|0.1976
72541976|NCT03944707|144613784|SUPERIORITY||Mean Difference (Net)|0.03|STANDARD_DEVIATION|0.0698||0.6643|TWO_SIDED|80.0|-0.06|0.119||Probability LOU064 better than placebo|Bayesian model for repeated measures||Posterior mean difference (LOU064 - placebo) and 80% credible interval are presented.|||0.119|-0.060|0.6643
72541977|NCT03944707|144613788|SUPERIORITY||Median Difference (Net)|-0.09|STANDARD_DEVIATION|0.21||0.6609|TWO_SIDED|80.0|-0.35|0.18||Probability LOU064 better than placebo|Bayesian model for repeated measures||Posterior mean difference (LOU064 - placebo) and 80% credible interval are presented.|||0.18|-0.35|0.6609
72541978|NCT03944707|144613789|SUPERIORITY||Mean Difference (Net)|0.1|STANDARD_DEVIATION|7.13||0.5107|TWO_SIDED|80.0|-9.0|9.1||Probability LOU064 better than placebo|Bayesian model for repeated measures||Posterior mean difference (LOU064 - placebo) and 80% credible interval are presented.|Change from baseline in mean morning PEF||9.1|-9.0|0.5107
72541979|NCT03944707|144613789|SUPERIORITY||Mean Difference (Net)|-3.4|STANDARD_DEVIATION|9.15||0.3611|TWO_SIDED|80.0|-15.2|8.1||Probability LOU064 better than placebo|Bayesian model for repeated measures||Posterior mean difference (LOU064 - placebo) and 80% credible interval are presented.|Change from baseline in mean evening PEF||8.1|-15.2|0.3611
72541980|NCT03944707|144613790|SUPERIORITY||Mean Difference (Net)|-0.133|STANDARD_DEVIATION|0.1588||0.8022|TWO_SIDED|80.0|-0.336|0.071||Probability LOU064 better than placebo|Bayesian model||Posterior mean difference (LOU064 - placebo) and 80% credible interval are presented.|||0.071|-0.336|0.8022
72541981|NCT03944707|144613791|SUPERIORITY||Mean Difference (Net)|-0.05|STANDARD_DEVIATION|0.1573||0.6312|TWO_SIDED|80.0|-0.251|0.149||Probability LOU064 better than placebo|Bayesian model for repeated measures||Posterior mean difference (LOU064 - placebo) and 80% credible interval are presented.|Change from baseline in daytime asthma symptom score||0.149|-0.251|0.6312
72541982|NCT03944707|144613791|SUPERIORITY||Mean Difference (Net)|0.075|STANDARD_DEVIATION|0.0819||0.1752|TWO_SIDED|80.0|-0.028|0.18||Probability LOU064 better than placebo|Bayesian model for repeated measures||Posterior mean difference (LOU064 - placebo) and 80% credible interval are presented.|Change from baseline in nighttime asthma symptom score||0.180|-0.028|0.1752
72541983|NCT01507831|144613795|SUPERIORITY_OR_OTHER||LS Mean Difference|-61.9|||<|0.0001|TWO_SIDED|95.0|-64.3|-59.4||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. Placebo|Alirocumab group was compared to placebo group using an appropriate contrast statement.||-59.4|-64.3|<0.0001
72541984|NCT01507831|144613796|SUPERIORITY_OR_OTHER||LS Mean Difference|-63.5|||<|0.0001|TWO_SIDED|95.0|-65.9|-61.2||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. Placebo|A hierarchial testing procedure was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially in the order the endpoints are reported. The hierarchial testing sequence continued only when previous endpoint was statistically significant at 0.05 level.||-61.2|-65.9|<0.0001
72541985|NCT01507831|144613797|SUPERIORITY_OR_OTHER||LS Mean Difference|-64.8|||<|0.0001|TWO_SIDED|95.0|-67.2|-62.4||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-62.4|-67.2|<0.0001
72541986|NCT01507831|144613798|SUPERIORITY_OR_OTHER||LS Mean Difference|-65.5|||<|0.0001|TWO_SIDED|95.0|-67.9|-63.2||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-63.2|-67.9|<0.0001
72541987|NCT01507831|144613799|SUPERIORITY_OR_OTHER||LS Mean Difference|-61.3|||<|0.0001|TWO_SIDED|95.0|-64.0|-58.5||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-58.5|-64.0|<0.0001
72410117|NCT02447991|144328603|SUPERIORITY||||||<|0.14||||||Significance threshold p\<0.05|Chi-squared, Corrected|This analysis applies to proportion of treated episodes.||Hypothesis: Rizatriptan will be superior to placebo in reducing the severity of headaches as measured by the proportion of treated episodes in which subjects experience a reduction in severity rating from Grade 3/2 to Grade 1/0 at 1 hour after taking study medication.||||<0.14
72541988|NCT01507831|144613800|SUPERIORITY_OR_OTHER||LS Mean Difference|-54.0|||<|0.0001|TWO_SIDED|95.0|-56.3|-51.7||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-51.7|-56.3|<0.0001
72541989|NCT01507831|144613801|SUPERIORITY_OR_OTHER||LS Mean Difference|-55.5|||<|0.0001|TWO_SIDED|95.0|-57.7|-53.2||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-53.2|-57.7|<0.0001
72576823|NCT00261443|144680657|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.13||||0.251|TWO_SIDED|95.0|-0.35|0.09||Baseline: ANOVA model, controlling for treatment, mood stabilizer, and index mood episode. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 20 Comparison||0.09|-0.35|0.251
72541990|NCT01507831|144613802|SUPERIORITY_OR_OTHER||LS Mean Difference|-52.3|||<|0.0001|TWO_SIDED|95.0|-54.4|-50.2||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-50.2|-54.4|<0.0001
72541991|NCT01507831|144613803|SUPERIORITY_OR_OTHER||LS Mean Difference|-53.7|||<|0.0001|TWO_SIDED|95.0|-55.7|-51.6||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-51.6|-55.7|<0.0001
72541992|NCT01507831|144613804|SUPERIORITY_OR_OTHER||LS Mean Difference|-37.5|||<|0.0001|TWO_SIDED|95.0|-39.1|-35.9||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-35.9|-39.1|<0.0001
72541993|NCT01507831|144613805|SUPERIORITY_OR_OTHER||LS Mean Difference|-56.0|||<|0.0001|TWO_SIDED|95.0|-58.3|-53.7||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-53.7|-58.3|<0.0001
72541994|NCT01507831|144613806|SUPERIORITY_OR_OTHER||LS Mean Difference|-54.6|||<|0.0001|TWO_SIDED|95.0|-56.6|-52.6||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-52.6|-56.6|<0.0001
72541995|NCT01507831|144613807|SUPERIORITY_OR_OTHER||LS Mean Difference|-39.0|||<|0.0001|TWO_SIDED|95.0|-40.4|-37.5||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-37.5|-40.4|<0.0001
72541996|NCT01507831|144613808|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|71.5|||<|0.0001|TWO_SIDED|95.0|51.6|99.1||Threshold for significance ≤ 0.05.|Regression, Logistic|Multiple imputation approach followed by logistic regression model.|Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||99.1|51.6|<0.0001
72541997|NCT01507831|144613809|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|93.4|||<|0.0001|TWO_SIDED|95.0|66.1|132.0||Threshold for significance ≤ 0.05.|Regression, Logistic|Multiple imputation approach followed by logistic regression model.|Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||132.0|66.1|<0.0001
72541998|NCT01507831|144613810|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|74.6|||<|0.0001|TWO_SIDED|95.0|53.3|104.4||Threshold for significance ≤ 0.05.|Regression, Logistic|Multiple imputation approach followed by logistic regression model.|Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||104.4|53.3|<0.0001
72541999|NCT01507831|144613811|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|97.3|||<|0.0001|TWO_SIDED|95.0|68.2|138.9||Threshold for significance ≤ 0.05.|Regression, Logistic|Multiple imputation approach followed by logistic regression model.|Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||138.9|68.2|<0.0001
72542000|NCT01507831|144613812|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-25.6|||<|0.0001|TWO_SIDED|95.0|-28.1|-23.1||Threshold for significance ≤ 0.05.|Regression, Robust|Multiple imputation approach followed by a robust regression model.|Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-23.1|-28.1|<0.0001
72542001|NCT01507831|144613813|SUPERIORITY_OR_OTHER||LS Mean Difference|4.6|||<|0.0001|TWO_SIDED|95.0|3.3|5.9||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||5.9|3.3|<0.0001
72542002|NCT01507831|144613814|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-17.3|||<|0.0001|TWO_SIDED|95.0|-20.1|-14.6||Threshold for significance ≤ 0.05.|Regression, Robust|Multiple imputation approach followed by a robust regression model.|Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-14.6|-20.1|<0.0001
72542003|NCT01507831|144613815|SUPERIORITY_OR_OTHER||LS Mean Difference|2.9|||<|0.0001|TWO_SIDED|95.0|1.6|4.2||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||4.2|1.6|<0.0001
72542004|NCT01507831|144613816|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-25.1|||<|0.0001|TWO_SIDED|95.0|-27.4|-22.7||Threshold for significance ≤ 0.05.|Regression, Robust|Multiple imputation approach followed by a robust regression model.|Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-22.7|-27.4|<0.0001
72542005|NCT01507831|144613817|SUPERIORITY_OR_OTHER||LS Mean Difference|5.6|||<|0.0001|TWO_SIDED|95.0|4.3|6.8||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||6.8|4.3|<0.0001
72542006|NCT01507831|144613818|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-17.9|||<|0.0001|TWO_SIDED|95.0|-20.5|-15.3||Threshold for significance ≤ 0.05.|Regression, Robust|Multiple imputation approach followed by a robust regression model.|Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-15.3|-20.5|<0.0001
72542007|NCT01507831|144613819|SUPERIORITY_OR_OTHER||LS Mean Difference|4.0|||<|0.0001|TWO_SIDED|95.0|2.8|5.2||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||5.2|2.8|<0.0001
72542008|NCT02713243|144613839|SUPERIORITY||Mean Difference (Net)|4.04||||0.01|TWO_SIDED|95.0|0.98|7.11|||Mixed Models Analysis|||Week 1 (Period 1 \& 2)||7.11|0.98|0.01
72542009|NCT02713243|144613839|SUPERIORITY||Mean Difference (Net)|1.31||||0.401|TWO_SIDED|95.0|-1.77|4.38|||Mixed Models Analysis|||Week 2 (Period 1 \& 2)||4.38|-1.77|0.401
72542010|NCT02713243|144613839|SUPERIORITY||Mean Difference (Net)|2.67||||0.019|TWO_SIDED|95.0|0.46|4.89|||Mixed Models Analysis|||Week 1\&2 (Period 1 \& 2)||4.89|0.46|0.019
72542011|NCT02713243|144613844|SUPERIORITY||Mean Difference (Net)|0.12||||0.533|TWO_SIDED|95.0|-0.27|0.52|||Mixed Models Analysis|||Week 1 (Period 1 \& 2)||0.52|-0.27|0.533
72542012|NCT02713243|144613844|SUPERIORITY||Mean Difference (Net)|-0.09||||0.64|TWO_SIDED|95.0|-0.49|0.3|||Mixed Models Analysis|||Week 2 (Period 1 \& 2)||0.30|-0.49|0.640
72542013|NCT02713243|144613844|SUPERIORITY||Mean Difference (Net)|0.02||||0.916|TWO_SIDED|95.0|-0.27|0.3|||Mixed Models Analysis|||Week 1\&2 (Period 1 \& 2)||0.30|-0.27|0.916
72542014|NCT02766400|144613862|SUPERIORITY_OR_OTHER_LEGACY||Cohen's d effect size at 12 months|0.53|||<|0.001|TWO_SIDED|95.0|-0.12|1.19||a priori threshold was set at p\<0.05|Linear mixed models|F(4,150)=5.11|Effect size was calculated using mean change scores (baseline to month 12) and standard error of change (baseline to month 12) for each group.|All analyses were performed using the intent-to-treat principle so that comparisons were made according to the assigned intervention group regardless of study completion.||1.19|-0.12|<0.001
72542015|NCT00204932|144613863|NON_INFERIORITY_OR_EQUIVALENCE|Power analysis was based on test-retest variance of body fat mass measure by DEXA|||||<|0.05||95.0|||||ANOVA|||Analysis of variance to test CLA not equal to placebo||||<0.05
72542016|NCT00204932|144613863|SUPERIORITY||||||<|0.05|||||||ANOVA|||Pre- post treatment comparison o fat oxidation found that fat oxidation increased in CLA (4 +/- 8 g) and decreased in placebo (-7 +/- 11 g) groups during sleep. after 6 mo of supplementation.||||<0.05
72542017|NCT03593772|144613865|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|-0.04819|STANDARD_ERROR_OF_MEAN|0.02482||0.0535|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on Total POQ Score as the outcome variable. Linear mixed models were constructed with fixed effects terms for the treatment group (MR vs. WC), time (continuous), and a treatment group x time interaction term to test whether the rate of change in the instrument score differed by treatment group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.05. Borderline statistical significance was considered to be \<0.1.||||0.0535
72542018|NCT03593772|144613865|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|-0.00163|STANDARD_ERROR_OF_MEAN|0.001826||0.3729|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on Pain Rating as the outcome variable. Linear mixed models were constructed with fixed effects terms for the treatment group (MR vs. WC), time (continuous), and a treatment group x time interaction term to test whether the rate of change in the instrument score differed by treatment group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.05. Borderline statistical significance was considered to be \<0.1.||||0.3729
72542019|NCT03593772|144613865|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|-0.00593|STANDARD_ERROR_OF_MEAN|0.007228||0.4124|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on Mobility as the outcome variable. Linear mixed models were constructed with fixed effects terms for the treatment group (MR vs. WC), time (continuous), and a treatment group x time interaction term to test whether the rate of change in the instrument score differed by treatment group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.05. Borderline statistical significance was considered to be \<0.1.||||0.4124
72542020|NCT03593772|144613865|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|-0.00432|STANDARD_ERROR_OF_MEAN|0.009334||0.6442|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on Activities of Daily Living as outcome variable. Linear mixed models were constructed with fixed effects terms for treatment group (MR vs. WC), time (continuous), and a treatment group x time interaction term to test if the rate of change in the instrument score differed by treatment group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.05. Borderline statistical significance was considered to be \<0.1.||||0.6442
72576824|NCT00261443|144680657|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.17||||0.135|TWO_SIDED|95.0|-0.4|0.05||Baseline: ANOVA model, controlling for treatment, mood stabilizer, and index mood episode. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 24 Comparison||0.05|-0.40|0.135
72542021|NCT03593772|144613865|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|-0.00898|STANDARD_ERROR_OF_MEAN|0.006436||0.1641|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on Vitality as the outcome variable. Linear mixed models were constructed with fixed effects terms for the treatment group (MR vs. WC), time (continuous), and a treatment group x time interaction term to test whether the rate of change in the instrument score differed by treatment group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.05. Borderline statistical significance was considered to be \<0.1.||||0.1641
72542022|NCT03593772|144613865|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|-0.01952|STANDARD_ERROR_OF_MEAN|0.009846||0.0487|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on Neg. Affect as the outcome variable. Linear mixed models were constructed with fixed effects terms for the treatment group (MR vs. WC), time (continuous), and a treatment group x time interaction term to test whether the rate of change in the instrument score differed by treatment group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.05. Borderline statistical significance was considered to be \<0.1.||||0.0487
72542023|NCT03593772|144613865|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|-0.0066|STANDARD_ERROR_OF_MEAN|0.004644||0.1554|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on Fear as the outcome variable. Linear mixed models were constructed with fixed effects terms for the treatment group (MR vs. WC), time (continuous), and a treatment group x time interaction term to test whether the rate of change in the instrument score differed by treatment group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.05. Borderline statistical significance was considered to be \<0.1.||||0.1554
72410118|NCT02447991|144328604|SUPERIORITY||||||<|0.72||||||Significance threshold p \< 0.05|Chi-squared, Corrected|This analysis applies to proportion of treated episodes||Hypothesis: Rizatriptan will be superior to placebo in reducing the severity of photophobia/phonophobia as measured by the proportion of treated episodes in which subjects experience a reduction in severity rating from Grade 3/2 to Grade 1/0 at 1 hour after taking study medication.||||<0.72
72542024|NCT03593772|144613866|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|-0.00113|STANDARD_ERROR_OF_MEAN|0.000863||0.1924|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on Pain as the outcome variable. Linear mixed models were constructed with fixed effects terms for the treatment group (MR vs. WC), time (continuous), and a treatment group x time interaction term to test whether the rate of change in the instrument score differed by treatment group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.1924
72542025|NCT03593772|144613866|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|-0.0019|STANDARD_ERROR_OF_MEAN|0.001152||0.1002|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on Stress as the outcome variable. Linear mixed models were constructed with fixed effects terms for the treatment group (MR vs. WC), time (continuous), and a treatment group x time interaction term to test whether the rate of change in the instrument score differed by treatment group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.1002
72542026|NCT03593772|144613866|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|0.000343|STANDARD_ERROR_OF_MEAN|0.000996||0.7311|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on Tension as the outcome variable. Linear mixed models were constructed with fixed effects terms for the treatment group (MR vs. WC), time (continuous), and a treatment group x time interaction term to test whether the rate of change in the instrument score differed by treatment group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.7311
72369256|NCT00611026|144248562|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.2||0.3161|TWO_SIDED|95.0|-0.5|0.2|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.|Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.|Treatment difference Tolterodine ER vs placebo at Week 1.||0.2|-0.5|0.3161
72369257|NCT00611026|144248562|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.1||0.1817|TWO_SIDED|95.0|-0.5|0.1|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.|Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.|Treatment difference Tolterodine ER vs Fesoterodine at Week 1.||0.1|-0.5|0.1817
72542027|NCT03593772|144613867|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|-0.00241|STANDARD_ERROR_OF_MEAN|0.001716||0.1622|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on Pain as the outcome variable. Linear mixed models were constructed with fixed effects terms for the treatment group (MR vs. WC), time (continuous), and a treatment group x time interaction term to test whether the rate of change in the instrument score differed by treatment group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.1622
72542028|NCT03593772|144613867|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|-0.00235|STANDARD_ERROR_OF_MEAN|0.002052||0.254|TWO_SIDED||||||Mixed Models Analysis|||Analysis performed on Pain Interference with Activity as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.2540
72542029|NCT03593772|144613867|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|-0.00612|STANDARD_ERROR_OF_MEAN|0.002297||0.0082|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on Pain Interference with Sleep as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.0082
72542030|NCT03593772|144613867|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|-0.00636|STANDARD_ERROR_OF_MEAN|0.002378||0.0079|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on Pain Interference with Mood as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.0079
72542031|NCT03593772|144613867|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|-0.00334|STANDARD_ERROR_OF_MEAN|0.002367||0.1588|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on Pain Interference with Stress as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.1588
72542032|NCT03593772|144613868|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|-0.00974|STANDARD_ERROR_OF_MEAN|0.01379||0.4808|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on PCL-5 Total Score as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.4808
72542033|NCT03593772|144613869|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|-0.00033|STANDARD_ERROR_OF_MEAN|0.00856||0.9692|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on Physical Health Domain Score as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.9692
72542034|NCT03593772|144613869|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|0.01738|STANDARD_ERROR_OF_MEAN|0.007848||0.0277|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on Mental Health Domain Score as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.0277
72542035|NCT03593772|144613870|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|-0.00188|STANDARD_ERROR_OF_MEAN|0.003253||0.5642|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on Total PSQI Score as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.5642
72576386|NCT02714426|144679372|OTHER|||||||0.439||||||A priori threshold for statistical significance was set at p \< .05. No adjustment was made for multiple comparisons. The critical effect of interest evaluated here was the Linear Occasion (1-14) x Group (Brain Health vs. Mindfulness) interaction.|Mixed Models Analysis|F(1,31) = 0.616, p = 0.439, no adjustments.||Mixed effects models were used. Independent variables were linear and quadratic time/occasion, intervention group, and group-by-time interactions if appropriate. Preparatory to modeling, preliminary unconditional models were run to determine best fitting approaches for repeated and random covariance structures. Diagonal repeated covariance was best (heterogeneous variance over time, and no residual cross-time covariances).||||0.439
72542036|NCT03593772|144613870|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|-0.00092|STANDARD_ERROR_OF_MEAN|0.00079||0.2438|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on PSQI Subjective Sleep Quality Domain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.2438
72542037|NCT03593772|144613870|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|0.000304|STANDARD_ERROR_OF_MEAN|0.000885||0.7317|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on PSQI Sleep latency Domain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.7317
72542038|NCT03593772|144613870|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|-0.00062|STANDARD_ERROR_OF_MEAN|0.001327||0.6393|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on PSQI Sleep duration Domain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.6393
72542039|NCT03593772|144613870|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|-0.00112|STANDARD_ERROR_OF_MEAN|0.000873||0.1995|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on PSQI Sleep efficiency Domain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.1995
72542040|NCT03593772|144613870|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|-0.00072|STANDARD_ERROR_OF_MEAN|0.000675||0.2886|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on PSQI Sleep disturbance Domain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.2886
72542041|NCT03593772|144613870|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|0.002048|STANDARD_ERROR_OF_MEAN|0.001356||0.1323|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on PSQI Use of sleep medication Domain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.1323
72576387|NCT01727726|144679388|OTHER||Mean Difference (Final Values)|-1.48||||0.0078|TWO_SIDED|95.0|-2.56|-0.39|||Cochran-Mantel-Haenszel|Mixed-model repeated measures (MMRM)||||-0.39|-2.56|0.0078
72576388|NCT01727726|144679388|OTHER||Mean Difference (Final Values)|-0.3||||0.6642|TWO_SIDED|95.0|-1.63|1.04|||Cochran-Mantel-Haenszel|Mixed-model repeated measures (MMRM)||||1.04|-1.63|0.6642
72576389|NCT01727726|144679389|OTHER||Mean Difference (Final Values)|-0.23||||0.1334|TWO_SIDED|95.0|-0.52|0.07|||MMRM|Mixed-model repeated measures (MMRM)||||0.07|-0.52|0.1334
72369258|NCT00611026|144248562|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.2|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001|TWO_SIDED|95.0|-1.6|-0.8|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.|Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.|Treatment difference fesoterodine vs placebo at Week 4.||-0.8|-1.6|<0.0001
72576390|NCT01727726|144679389|OTHER||Mean Difference (Final Values)|0.42||||0.0237|TWO_SIDED|95.0|0.06|0.78|||MMRM|Mixed-model repeated measures (MMRM)||||0.78|0.06|0.0237
72576391|NCT01727726|144679390|OTHER||Mean Difference (Final Values)|-1.53||||0.0001|TWO_SIDED|95.0|-2.29|-0.76|||MMRM|Mixed-model repeated measures (MMRM)||Phase B week 2||-0.76|-2.29|0.0001
72576392|NCT01727726|144679390|OTHER||Mean Difference (Final Values)|-1.22||||0.0103|TWO_SIDED|95.0|-2.15|-0.29|||MMRM|Mixed-model repeated measures (MMRM)||Phase B Week 2||-0.29|-2.15|0.0103
72576393|NCT01727726|144679390|OTHER||Mean Difference (Final Values)|-1.17||||0.0185|TWO_SIDED|95.0|-2.15|-0.2|||MMRM|Mixed-model repeated measures (MMRM)||Phase B week 4||-0.20|-2.15|0.0185
72576394|NCT01727726|144679390|OTHER||Mean Difference (Final Values)|-0.08||||0.8949|TWO_SIDED|95.0|-1.27|1.11|||MMRM|Mixed-model repeated measures (MMRM)||Phase B Week 4||1.11|-1.27|0.8949
72576395|NCT01727726|144679391|OTHER||Mean Difference (Final Values)|-0.15||||0.035|TWO_SIDED|95.0|-0.29|-0.01|||Cochran-Mantel-Haenszel|||CGI-Severity of Illness Scale Score||-0.01|-0.29|0.0350
72576396|NCT01727726|144679391|OTHER||Mean Difference (Final Values)|-0.05||||0.5601|TWO_SIDED|95.0|-0.22|0.12|||Cochran-Mantel-Haenszel|||CGI-Severity of Illness Scale Score||0.12|-0.22|0.5601
72576397|NCT01727726|144679391|OTHER||Mean Difference (Final Values)|-0.19||||0.0146|TWO_SIDED|95.0|-0.35|-0.04|||Cochran-Mantel-Haenszel|||CGI-Improvement Scale Score||-0.04|-0.35|0.0146
72576398|NCT01727726|144679391|OTHER||Mean Difference (Final Values)|-0.04||||0.7127|TWO_SIDED|95.0|-0.23|0.15|||Cochran-Mantel-Haenszel|||CGI-Improvement Scale Score||0.15|-0.23|0.7127
72576399|NCT01727726|144679392|OTHER||Ratio of response rate|1.49||||0.2242|TWO_SIDED|95.0|0.78|2.84|||Cochran-Mantel-Haenszel|||Phase B Week 6||2.84|0.78|0.2242
72576400|NCT01727726|144679392|OTHER||Ratio of Response Rate|1.26||||0.5998|TWO_SIDED|95.0|0.53|2.98|||Cochran-Mantel-Haenszel|||Phase B Week 6||2.98|0.53|0.5998
72576401|NCT01727726|144679393|OTHER||Ratio of Response Rate|1.52||||0.3321|TWO_SIDED|95.0|0.66|3.49|||Cochran-Mantel-Haenszel|||Phase B Week 6||3.49|0.66|0.3321
72576402|NCT01727726|144679393|OTHER||Ratio of Response Rate|0.51||||0.3917|TWO_SIDED|95.0|0.11|2.46|||Cochran-Mantel-Haenszel|||Phase B Week 6||2.46|0.11|0.3917
72576403|NCT01727726|144679394|OTHER||Ratio of Response Rate|1.35||||0.0032|TWO_SIDED|95.0|1.1|1.66|||Cochran-Mantel-Haenszel|||Phase B Week 6||1.66|1.10|0.0032
72576404|NCT01727726|144679394|OTHER||Ratio of Response Rate|1.24||||0.0898|TWO_SIDED|95.0|0.98|1.59|||Cochran-Mantel-Haenszel|||Phase B Week 6||1.59|0.98|0.0898
72576405|NCT01727726|144679396|OTHER||Mean Difference (Final Values)|0.16||||0.448|TWO_SIDED|95.0|-0.25|0.56|||MMRM|Mixed-model repeated measures (MMRM)||Work/School Score||0.56|-0.25|0.4480
72628047|NCT02031302|144784282|OTHER|One-sided Clopper-Pearson 98.699% upper bound|||||<|0.0001||||||The proportion of patients who experience an event through 30 days post-procedure out of the patients who have either had an event within 30 days post-procedure or who were event-free with last follow-up at least 23 days post-procedure.|Chi-squared|||Note: the 95% CI is from Clopper-Pearson Exact Method. The analysis was only done for the Lotus valve arm as the Lotus with Depth Guard arm has not sufficient power for this statistical analysis.|One-sided Clopper-Pearson 98.699% upper bound: 4.11% Performance goal is 14%|||<.0001
72628048|NCT04712669|144784310|SUPERIORITY||Mean Difference (Final Values)|57.27|STANDARD_ERROR_OF_MEAN|24.773||0.0208|TWO_SIDED|95.0|8.716|105.824||LSM, SE, CIs for each treatment group; LSM Diff, SE, CIs, and p-value are estimated using an ANCOVA model incl. factors for treatment group and randomization strata with associated baseline value as a covariate.|ANCOVA|H0: The mean change from baseline in PVR at Week 24 is equal between placebo and rodatristat ethyl.||||105.824|8.716|0.0208
72628049|NCT04712669|144784310|SUPERIORITY||Mean Difference (Final Values)|58.406|STANDARD_ERROR_OF_MEAN|24.558||0.0174|TWO_SIDED|95.0|10.272|106.54||LSM, SE, CIs for each treatment group; LSM Diff, SE, CIs, and p-value are estimated using an ANCOVA model incl. factors for treatment group and randomization strata with associated baseline value as a covariate.|ANCOVA|H0: The mean change from baseline in PVR at Week 24 is equal between placebo and rodatristat ethyl.||||106.54|10.272|0.0174
72628050|NCT04712669|144784311|SUPERIORITY|||||||0.573||||||P-value based on ordinal logistic regression with treatment group and randomization stratification strata as factors at alpha=0.05.|Regression, Logistic|H0: The distribution of change from baseline in WHO FC at Week 24 is equal between placebo and rodatristat ethyl.||||||0.573
72628051|NCT04712669|144784311|SUPERIORITY|||||||0.9911||||||P-value based on ordinal logistic regression with treatment group and randomization stratification strata as factors at alpha=0.05.|Regression, Logistic|H0: The distribution of change from baseline in WHO FC at Week 24 is equal between placebo and rodatristat ethyl.||||||0.9911
72628052|NCT04712669|144784312|SUPERIORITY||Median Difference (Final Values)|-33.61|STANDARD_ERROR_OF_MEAN|18.121||0.0636|TWO_SIDED|95.0|-69.13|1.91||p-value (alpha=0.05) is estimated using the aligned rank stratified Wilcoxon test with the randomization stratification factors as strata.|Wilcoxon (Mann-Whitney)|H0: The distribution of change from baseline at Week 24 in 6MWT distance (meters) is equal between placebo and rodatristat ethyl.||||1.91|-69.13|0.0636
72628053|NCT04712669|144784312|SUPERIORITY||Median Difference (Final Values)|-19.05|STANDARD_ERROR_OF_MEAN|13.469||0.1573|TWO_SIDED|95.0|-45.45|7.35||p-value (alpha=0.05) is estimated using the aligned rank stratified Wilcoxon test with the randomization stratification factors as strata.|Wilcoxon (Mann-Whitney)|H0: The distribution of change from baseline at Week 24 in 6MWT distance (meters) is equal between placebo and rodatristat ethyl.||||7.35|-45.45|0.1573
72628054|NCT04712669|144784313|SUPERIORITY||Mean Difference (Final Values)|1125.9|STANDARD_ERROR_OF_MEAN|351.28||0.0014|TWO_SIDED|95.0|437.39|1814.39|||Mixed Models Analysis|H0: The mean change from baseline at Week 24 in NT-proBNP is equal between placebo and rodatristat ethyl.|Estimates from a REML MMRM with baseline covariate, fixed effects, and unstructured covariance.|||1814.39|437.39|0.0014
72628055|NCT04712669|144784313|SUPERIORITY||Mean Difference (Final Values)|866.3|STANDARD_ERROR_OF_MEAN|306.56||0.0047|TWO_SIDED|95.0|265.41|1467.16|||Mixed Models Analysis|H0: The mean change from baseline at Week 24 in NT-proBNP is equal between placebo and rodatristat ethyl.|Estimates from a REML MMRM with baseline covariate, fixed effects, and unstructured covariance.|||1467.16|265.41|0.0047
72576406|NCT01727726|144679396|OTHER||Mean Difference (Final Values)|0.52||||0.038|TWO_SIDED|95.0|0.03|1.02|||MMRM|Mixed-model repeated measures (MMRM)||Work/School Score||1.02|0.03|0.0380
72576407|NCT01727726|144679396|OTHER||Mean Difference (Final Values)|-0.34||||0.0436|TWO_SIDED|95.0|-0.66|-0.01|||MMRM|Mixed-model repeated measures (MMRM)||Social Life Score||-0.01|-0.66|0.0436
72628056|NCT03802396|144784314|OTHER|||||||0.025|||||||Wilcoxon (Mann-Whitney)|||||||0.025
72628057|NCT03802396|144784315|OTHER|||||||0.116|||||||Wilcoxon (Mann-Whitney)|||Baseline to 24 hours||||0.116
72628058|NCT03802396|144784315|OTHER|||||||0.388|||||||Wilcoxon (Mann-Whitney)|||Baseline to 6 weeks||||0.388
72628059|NCT03802396|144784316|OTHER|||||||0.569|||||||Wilcoxon (Mann-Whitney)|||Baseline to 24 hours||||0.569
72628060|NCT03802396|144784316|OTHER|||||||0.047|||||||Wilcoxon (Mann-Whitney)|||Baseline to 6 weeks||||0.047
72628061|NCT03802396|144784317|OTHER|||||||0.498|||||||Wilcoxon (Mann-Whitney)|||Baseline to 24 hours||||0.498
72628062|NCT03802396|144784317|OTHER|||||||0.745|||||||Wilcoxon (Mann-Whitney)|||Baseline to 6 weeks||||0.745
72628063|NCT03802396|144784318|OTHER|||||||0.177|||||||Wilcoxon (Mann-Whitney)|||Baseline to 24 hours||||0.177
72628064|NCT03802396|144784318|OTHER|||||||0.478|||||||Wilcoxon (Mann-Whitney)|||Baseline to 6 weeks||||0.478
72628065|NCT03802396|144784319|OTHER|||||||0.803|||||||t-test, 2 sided|||||||0.803
72628066|NCT03802396|144784321|OTHER||Risk Ratio (RR)|0.73||||0.286|TWO_SIDED|95.0|0.41|1.3|||Chi-squared|||||1.30|0.41|0.286
72628067|NCT03802396|144784322|OTHER|||||||0.189|||||||Wilcoxon (Mann-Whitney)|||||||0.189
72628068|NCT00163293|144784323|SUPERIORITY_OR_OTHER|||||||0.6625||95.0|||||Log Rank|||||||0.6625
72628069|NCT00163293|144784323|SUPERIORITY_OR_OTHER|||||||0.7303||95.0|||||Log Rank|||||||0.7303
72628070|NCT00163293|144784324|SUPERIORITY_OR_OTHER|||||||0.1291||95.0|||||Wald Chi-square|zero inflated Poisson model: adjustment for centre and age \[yrs\] (zero model), treatment and race (Poisson model)||||||0.1291
72628071|NCT00163293|144784324|SUPERIORITY_OR_OTHER|||||||0.0145||95.0|||||Wald Chi-square|zero inflated Poisson model: adjustment for centre and age \[yrs\] (zero model), treatment and race (Poisson model)||||||0.0145
72628072|NCT00163293|144784326|SUPERIORITY_OR_OTHER|||||||0.4754|||||||Kruskal-Wallis|||||||0.4754
72628073|NCT00163293|144784326|SUPERIORITY_OR_OTHER|||||||0.6844|||||||Kruskal-Wallis|||||||0.6844
72369259|NCT00611026|144248562|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.2||0.0054|TWO_SIDED|95.0|-1.0|-0.2|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.|Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.|Treatment difference Tolterodine ER vs placebo at Week 4.||-0.2|-1.0|0.0054
72576408|NCT01727726|144679396|OTHER||Mean Difference (Final Values)|0.43||||0.035|TWO_SIDED|95.0|0.03|0.84|||MMRM|Mixed-model repeated measures (MMRM)||Social Life Score||0.84|0.03|0.0350
72576409|NCT01727726|144679396|OTHER||Mean Difference (Final Values)|-0.35||||0.0424|TWO_SIDED|95.0|-0.69|-0.01|||MMRM|Mixed-model repeated measures (MMRM)||Family Life Score||-0.01|-0.69|0.0424
72576410|NCT01727726|144679396|OTHER||Mean Difference (Final Values)|0.33||||0.123|TWO_SIDED|95.0|-0.09|0.75|||MMRM|Mixed-model repeated measures (MMRM)||Family Life Score||0.75|-0.09|0.1230
72576411|NCT04762277|144679398|OTHER||Mean Difference (Net)|-4.1|||||TWO_SIDED|95.0|-31.7|23.4|||||Difference of Least Squares Means was calculated as: Spesolimab-Placebo.|MMRM accounting for the following sources of variation: fixed, categorical effects of treatment at each visit, the effect of stratum (stratification according to TNFi-naive population vs. TNFi-failure population) and the fixed continuous effects of baseline at each visit. The unstructured covariance structure was used to model the within patient measurements. To estimate denominator degrees of freedom the Kenward-Roger approximation was used.||23.4|-31.7|
72576412|NCT04762277|144679399|OTHER||Mean Difference (Net)|-96.6|||||TWO_SIDED|95.0|-154.5|-38.8|||||Difference of Least Squares Means was calculated as: Spesolimab-Placebo.|MMRM accounting for the following sources of variation: fixed, categorical effects of treatment at each visit, the effect of stratum (stratification according to TNFi-naive population vs. TNFi-failure population) and the fixed continuous effects of baseline at each visit. The unstructured covariance structure was used to model the within patient measurements. To estimate denominator degrees of freedom the Kenward-Roger approximation was used.||-38.8|-154.5|
72576413|NCT04762277|144679400|OTHER||Risk Difference (RD)|0.138|||||TWO_SIDED|95.0|-0.129|0.339|||||Risk difference was calculated as: Spesolimab - Placebo. 95% Confidence Interval (CI) for treatment difference is calculated by Chan and Zhang method.|The difference in the proportion of patients with a response between Spesolimab and placebo was analysed using a logistic regression model. The model included treatment and stratification factor (tumor necrosis factor inhibitor (TNFi)-naive population versus TNFi-failure population) as two categorical variables.||0.339|-0.129|
72576414|NCT04762277|144679401|OTHER||Mean Difference (Net)|-13.9|||||TWO_SIDED|95.0|-25.6|-2.3|||||Difference of Least Squares Means was calculated as: Spesolimab-Placebo.|MMRM accounting for the following sources of variation: fixed, categorical effects of treatment at each visit, the effect of stratum (stratification according to TNFi-naive population vs. TNFi-failure population) and the fixed continuous effects of baseline at each visit. The unstructured covariance structure was used to model the within patient measurements. To estimate denominator degrees of freedom the Kenward-Roger approximation was used.||-2.3|-25.6|
72576415|NCT04762277|144679402|OTHER||Mean Difference (Net)|-19.8|||||TWO_SIDED|95.0|-36.9|-2.7|||||Difference of Least Squares Means was calculated as : Spesolimab- Placebo.|MMRM accounting for the following sources of variation: fixed, categorical effects of treatment at each visit, the effect of stratum (stratification according to TNFi-naive population vs. TNFi-failure population) and the fixed continuous effects of baseline at each visit. The unstructured covariance structure was used to model the within patient measurements. To estimate denominator degrees of freedom the Kenward-Roger approximation was used.||-2.7|-36.9|
72576416|NCT04762277|144679403|OTHER||Risk Difference (RD)|0.057|||||TWO_SIDED|95.0|-0.132|0.186|||||Risk difference was calculated as: Spesolimab-Placebo. 95% Confidence Interval (CI) for treatment difference is calculated by Chan and Zhang method.|The difference in the proportion of patients with a response between Spesolimab and placebo was analysed using a logistic regression model. The model included treatment and stratification factor (tumor necrosis factor inhibitor (TNFi)-naive population versus TNFi-failure population) as two categorical variables.||0.186|-0.132|
72576417|NCT04762277|144679404|OTHER||Risk Difference (RD)|0.17|||||TWO_SIDED|95.0|-0.067|0.338|||||Risk Difference was calculated as: Spesolimab - Placebo. 95% Confidence Interval (CI) for treatment difference was calculated by Chan and Zhang method.|The difference in the proportion of patients with a response between Spesolimab and placebo was analysed using a logistic regression model. The model included treatment and stratification factor (tumor necrosis factor inhibitor (TNFi)-naive population versus TNFi-failure population) as two categorical variables.||0.338|-0.067|
72542042|NCT03593772|144613870|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|0.000209|STANDARD_ERROR_OF_MEAN|0.000793||0.7923|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on PSQI Daytime dysfunction Domain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.7923
72542043|NCT03593772|144613871|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|-0.00046|STANDARD_ERROR_OF_MEAN|0.001074||0.6679|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on COS Total Score as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.6679
72542044|NCT03593772|144613871|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|0.001083|STANDARD_ERROR_OF_MEAN|0.000769||0.1607|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on COS Total Score as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.1607
72542045|NCT03593772|144613871|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|0.000984|STANDARD_ERROR_OF_MEAN|0.00064||0.126|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on CSS- Total as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.1260
72542046|NCT03593772|144613871|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|0.000909|STANDARD_ERROR_OF_MEAN|0.000933||0.3311|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on CSS Self-Kindness Domain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.3311
72542047|NCT03593772|144613871|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|0.001041|STANDARD_ERROR_OF_MEAN|0.000887||0.2416|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on CSS Self-Judgment Domain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.2416
72542048|NCT03593772|144613871|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|-0.00087|STANDARD_ERROR_OF_MEAN|0.001016||0.3903|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on CSS Common Humanity Domain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.3903
72542049|NCT03593772|144613871|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|0.001186|STANDARD_ERROR_OF_MEAN|0.00095||0.2131|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on CSS Isolation Domain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.2131
72542050|NCT03593772|144613871|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|0.001485|STANDARD_ERROR_OF_MEAN|0.000933||0.113|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on CSS Mindfulness Domain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.1130
72542051|NCT03593772|144613871|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|0.001983|STANDARD_ERROR_OF_MEAN|0.000939||0.0358|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on CSS Over-identification Domain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.0358
72410119|NCT02447991|144328605|SUPERIORITY||||||<|0.48||||||Significance threshold p \< 0.05|Chi-squared, Corrected|This analysis applies to proportion of treated episodes||Hypothesis: Rizatriptan will be superior to placebo in reducing the severity of sensitivity to motion as measured by the proportion of treated episodes in which subjects experience a reduction in severity rating from Grade 3/2 to Grade 1/0 at 1 hour after taking study medication.||||<0.48
72410120|NCT02447991|144328606|SUPERIORITY||||||<|0.35||||||Significance threshold p \< 0.05|Chi-squared, Corrected|This analysis applies to proportion of treated episodes||Hypothesis: Rizatriptan will be superior to placebo in reducing the severity of nausea/vomiting as measured by the proportion of treated episodes in which subjects experience a reduction in severity rating from Grade 3/2 to Grade 1/0 at 1 hour after taking study medication..||||<0.35
72542052|NCT03593772|144613871|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|-0.00019|STANDARD_ERROR_OF_MEAN|0.000495||0.7027|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on CSS- Total Score as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.7027
72542053|NCT03593772|144613871|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|0.000761|STANDARD_ERROR_OF_MEAN|0.00073||0.2979|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on CSS Self-Kindness Domain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.2979
72576418|NCT04762277|144679405|OTHER||Risk Difference (RD)|0.183|||||TWO_SIDED|95.0|-0.079|0.375|||||Risk Difference was calculated as: Spesolimab - Placebo. 95% Confidence Interval (CI) for treatment difference was calculated by Chan and Zhang method.|The difference in the proportion of patients with a response between Spesolimab and placebo was analysed using a logistic regression model. The model included treatment and stratification factor (tumor necrosis factor inhibitor (TNFi)-naive population versus TNFi-failure population) as two categorical variables.||0.375|-0.079|
72576419|NCT04762277|144679406|OTHER||Risk Difference (RD)|-0.091|||||TWO_SIDED|95.0|-0.331|0.089|||||Risk Difference was calculated as: Spesolimab - Placebo. 95% Confidence Interval (CI) for treatment difference was calculated by Chan and Zhang method.|The difference in the proportion of patients with a response between Spesolimab and placebo was analysed using a logistic regression model. The model included treatment and stratification factor (tumor necrosis factor inhibitor (TNFi)-naive population versus TNFi-failure population) as two categorical variables.||0.089|-0.331|
72576420|NCT04762277|144679407|OTHER||Mean Difference (Net)|-0.1|||||TWO_SIDED|95.0|-4.4|4.3|||||Difference of Least Squares Means was calculated as: Spesolimab-Placebo.|MMRM accounting for the following sources of variation: fixed, categorical effects of treatment at each visit, the effect of stratum (stratification according to TNFi-naive population vs. TNFi-failure population) and the fixed continuous effects of baseline at each visit. The unstructured covariance structure was used to model the within patient measurements. To estimate denominator degrees of freedom the Kenward-Roger approximation was used.||4.3|-4.4|
72576421|NCT04762277|144679408|OTHER||Mean Difference (Net)|-1.3|||||TWO_SIDED|95.0|-9.5|6.9|||||Difference of Least Squares Means was calculated as: Spesolimab-Placebo.|MMRM accounting for the following sources of variation: fixed, categorical effects of treatment at each visit, the effect of stratum (stratification according to TNFi-naive population vs. TNFi-failure population) and the fixed continuous effects of baseline at each visit. The unstructured covariance structure was used to model the within patient measurements. To estimate denominator degrees of freedom the Kenward-Roger approximation was used.||6.9|-9.5|
72576422|NCT00658021|144679449|SUPERIORITY||LS Mean Difference|-0.28|STANDARD_ERROR_OF_MEAN|0.363||0.444|TWO_SIDED|95.0|-1.01|0.45|||Mixed Models Analysis|||Adjusted LS mean and treatment group difference in the change from baseline values at visit are obtained from a MMRM including treatment, baseline HbA1c, background diabetes therapy strata, week of visit, baseline HbA1c-by-visit interaction and treatment-by-visit interaction as fixed effects using an unstructured covariance matrix.||0.45|-1.01|0.444
72576423|NCT00658021|144679451|SUPERIORITY|||||||0.562|||||||Cochran-Mantel-Haenszel|||"Treatment difference in HbA1c \< 7% at Week 28:~Treatment group comparison is based on CMH test stratified by screening HbA1c and background diabetes therapy strata. P-value is from the general association statistics."||||0.562
72576424|NCT00658021|144679451|SUPERIORITY|||||||0.621|||||||Cochran-Mantel-Haenszel|||"Treatment difference in HbA1c \<= 6.5% at Week 28:~Treatment group comparison is based on CMH test stratified by screening HbA1c and background diabetes therapy strata. P-value is from the general association statistics."||||0.621
72576425|NCT00658021|144679451|SUPERIORITY|||||||0.229|||||||Cochran-Mantel-Haenszel|||"Treatment difference in HbA1c \< 6.5% at Week 28:~Treatment group comparison is based on CMH test stratified by screening HbA1c and background diabetes therapy strata. P-value is from the general association statistics."||||0.229
72576426|NCT00658021|144679452|SUPERIORITY||LS Mean Difference|-0.93|STANDARD_ERROR_OF_MEAN|0.327||0.005|TWO_SIDED|95.0|-1.58|-0.28|||Mixed Models Analysis|||"Treatment difference in body weight at Week 4:~Adjusted LS mean and treatment group difference in the change from baseline values at visit are obtained from a MMRM including treatment, baseline body weight, screening HbA1c strata, background diabetes therapy strata, week of visit, baseline body weight-by visit interaction and treatment-by-visit interaction as fixed effects using an unstructured covariance matrix."||-0.28|-1.58|0.005
72542054|NCT03593772|144613871|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|-0.00063|STANDARD_ERROR_OF_MEAN|0.000798||0.4278|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on CSS Self-Judgment Domain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.4278
72542055|NCT03593772|144613871|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|-0.0000074|STANDARD_ERROR_OF_MEAN|0.000877||0.9933|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on CSS Common Humanity Domain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.9933
72542056|NCT03593772|144613871|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|-0.00115|STANDARD_ERROR_OF_MEAN|0.000816||0.1589|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on CSS Isolation Domain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.1589
72542057|NCT03593772|144613871|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|0.000109|STANDARD_ERROR_OF_MEAN|0.000767||0.8875|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on CSS Mindfulness Domain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.8875
72576427|NCT00658021|144679452|SUPERIORITY||LS Mean Difference|-0.68|STANDARD_ERROR_OF_MEAN|0.669||0.314|TWO_SIDED|95.0|-2.0|0.65|||Mixed Models Analysis|||"Treatment difference in body weight at Week 12:~Adjusted LS mean and treatment group difference in the change from baseline values at visit are obtained from a MMRM including treatment, baseline body weight, screening HbA1c strata, background diabetes therapy strata, week of visit, baseline body weight-by visit interaction and treatment-by-visit interaction as fixed effects using an unstructured covariance matrix."||0.65|-2.00|0.314
72576428|NCT00658021|144679452|SUPERIORITY||LS Mean Difference|-0.37|STANDARD_ERROR_OF_MEAN|0.94||0.692|TWO_SIDED|95.0|-2.24|1.5|||Mixed Models Analysis|||"Treatment difference in body weight at Week 20:~Adjusted LS mean and treatment group difference in the change from baseline values at visit are obtained from a MMRM including treatment, baseline body weight, screening HbA1c strata, background diabetes therapy strata, week of visit, baseline body weight-by visit interaction and treatment-by-visit interaction as fixed effects using an unstructured covariance matrix."||1.50|-2.24|0.692
72576429|NCT00658021|144679452|SUPERIORITY||LS Mean Difference|-0.44|STANDARD_ERROR_OF_MEAN|1.065||0.679|TWO_SIDED|95.0|-2.56|1.68|||Mixed Models Analysis|||"Treatment difference in body weight at Week 28:~Adjusted LS mean and treatment group difference in the change from baseline values at visit are obtained from a MMRM including treatment, baseline body weight, screening HbA1c strata, background diabetes therapy strata, week of visit, baseline body weight-by visit interaction and treatment-by-visit interaction as fixed effects using an unstructured covariance matrix."||1.68|-2.56|0.679
72576430|NCT00658021|144679453|SUPERIORITY||LS Mean Difference|-0.281|STANDARD_ERROR_OF_MEAN|0.68||0.679|TWO_SIDED|95.0|-1.614|1.052|||ANCOVA|||Adjusted LS Mean and treatment group difference in the change from baseline values at Week 28 are obtained from multiple imputation ANCOVA including treatment, baseline fasting serum glucose, screening HbA1c strata and background diabetes therapy strata as fixed effects.||1.052|-1.614|0.679
72576431|NCT00658021|144679454|SUPERIORITY||LS Mean Difference|0.189|STANDARD_ERROR_OF_MEAN|0.5151||0.714|TWO_SIDED|95.0|-0.821|1.199|||ANCOVA|||Treatment difference for pre-meal SMBG: Adjusted LS Mean and treatment group difference in the change from baseline values at Week 28 are obtained from multiple imputation ANCOVA including treatment, baseline SMBG measure, screening HbA1c strata and background diabetes therapy strata as fixed effects.||1.199|-0.821|0.714
72576432|NCT00658021|144679454|SUPERIORITY||LS Mean Difference|0.513|STANDARD_ERROR_OF_MEAN|0.5245||0.329|TWO_SIDED|95.0|-0.516|1.541|||ANCOVA|||Treatment difference for post-meal SMBG: Adjusted LS Mean and treatment group difference in the change from baseline values at Week 28 are obtained from multiple imputation ANCOVA including treatment, baseline SMBG measure, screening HbA1c strata and background diabetes therapy strata as fixed effects.||1.541|-0.516|0.329
72628074|NCT01978145|144784359|NON_INFERIORITY_OR_EQUIVALENCE|Non- inferiority was demonstrated if lower limit of the CI (0.025 one sided significance level) for the difference of the mean change from Baseline in trough FEV1 of FSC administered BID by CB DPI versus FSC administered BID by MD DPI is greater than -45 milliliter (mL).|Mean Difference (Net)|0.025|||||TWO_SIDED|95.0|0.002|0.047|||Repeated Measures Mixed Models|||||0.047|0.002|
72576433|NCT00658021|144679454|SUPERIORITY||LS Mean Difference|0.21|STANDARD_ERROR_OF_MEAN|0.4015||0.601|TWO_SIDED|95.0|-0.577|0.997|||ANCOVA|||Treatment difference for post-prandial excursion SMBG: Adjusted LS Mean and treatment group difference in the change from baseline values at Week 28 are obtained from multiple imputation ANCOVA including treatment, baseline SMBG measure, screening HbA1c strata and background diabetes therapy strata as fixed effects.||0.997|-0.577|0.601
72628075|NCT01978145|144784360|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.004|||||TWO_SIDED|95.0|-0.019|0.027|||||The estimated value and 95% CI values are provided for Day 28|||0.027|-0.019|
72628076|NCT01978145|144784360|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.02|||||TWO_SIDED|95.0|-0.005|0.044|||||The estimated value and 95% CI values are provided for Day 56|||0.044|-0.005|
72628077|NCT01978145|144784361|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.166||||||95.0|-0.06|0.393||||||||0.393|-0.060|
72410121|NCT02447991|144328607|SUPERIORITY||||||<|0.022||||||Significance of threshold p\<0.05|Regression, Linear|This analysis applies to proportion of treated episodes.||Hypothesis: Rizatriptan will be superior to placebo on the Treatment Satisfaction Questionnaire for Medication at 48 hours after each attack treated with effectiveness of study medication||||<0.022
72410122|NCT02447991|144328607|SUPERIORITY||||||<|0.418||||||Significance of threshold p\<0.05|Regression, Linear|This analysis applies to proportion of treated episodes.||Hypothesis: Rizatriptan will be superior to placebo on the Treatment Satisfaction Questionnaire for Medication at 48 hours after each attack treated with side effects of study medication||||<0.418
72410123|NCT02447991|144328607|SUPERIORITY||||||<|0.674||||||Significance of threshold p\<0.05|Regression, Linear|This analysis applies to proportion of treated episodes.||Hypothesis: Rizatriptan will be superior to placebo on the Treatment Satisfaction Questionnaire for Medication at 48 hours after each attack treated with convenience of study medication||||<0.674
72542058|NCT03593772|144613871|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|-0.00032|STANDARD_ERROR_OF_MEAN|0.00078||0.6859|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on CSS Over-identification Domain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.6859
72410124|NCT02447991|144328607|SUPERIORITY||||||<|0.016||||||Significance of threshold of p\<0.05|Regression, Linear|This analysis applies to proportion of treated episodes.||Hypothesis: Rizatriptan will be superior to placebo on the Treatment Satisfaction Questionnaire for Medication at 48 hours after each attack treated with overall satisfaction of study medication||||<0.016
72410125|NCT02447991|144328608|SUPERIORITY||||||<|0.009||||||Significance threshold p\<0.05|Regression, Linear|This analysis applies to proportion of treated episodes.||Hypothesis: Rizatriptan will be superior to placebo on physical well-being||||<0.009
72542059|NCT03593772|144613872|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|-0.01408|STANDARD_ERROR_OF_MEAN|0.01085||0.1959|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on BDI total score as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.1959
72542060|NCT03593772|144613873|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|-0.00788|STANDARD_ERROR_OF_MEAN|0.005845||0.1792|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on Perceived Stress Scale Score as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.1792
72576434|NCT00658021|144679454|SUPERIORITY||LS Mean Difference|0.316|STANDARD_ERROR_OF_MEAN|0.4749||0.505|TWO_SIDED|95.0|-0.615|1.248|||ANCOVA|||Treatment difference for overall SMBG: Adjusted LS Mean and treatment group difference in the change from baseline values at Week 28 are obtained from multiple imputation ANCOVA including treatment, baseline SMBG measure, screening HbA1c strata and background diabetes therapy strata as fixed effects.||1.248|-0.615|0.505
72576435|NCT00658021|144679455|SUPERIORITY||LS Mean Difference|-10.82|STANDARD_ERROR_OF_MEAN|43.187||0.802|TWO_SIDED|95.0|-95.48|73.84|||ANCOVA|||Adjusted LS Mean and treatment group difference in the change from baseline values at Week 28 are obtained from multiple imputation ANCOVA including treatment, baseline fasting serum insulin, screening HbA1c strata and background diabetes therapy strata as fixed effects.||73.84|-95.48|0.802
72628078|NCT01978145|144784362|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.003|||||TWO_SIDED|95.0|-0.278|0.272|||||The estimated and 95% CI values are presented for Day 28.|||0.272|-0.278|
72410126|NCT02447991|144328608|SUPERIORITY||||||<|0.467||||||Significance threshold p\<0.05|Regression, Linear|This analysis applies to proportion of treated episodes.||Hypothesis: Rizatriptan will be superior to placebo on mental well-being||||<0.467
72410127|NCT02447991|144328609|SUPERIORITY||||||<|0.013||||||Significance threshold p\<0.05|Logistic regression with GEE|GEE=generalized estimating equations - this accounts for repeated measures within patients.This analysis applies to proportion of treated episodes.||Hypothesis: Rizatriptan will be tolerated as well as placebo with regard to fatigue.||||<0.013
72410128|NCT02447991|144328609|SUPERIORITY||||||<|0.021||||||Significance threshold p\<0.05|Logistic regression with GEE|GEE=generalized estimating equations - this accounts for repeated measures within patients. This analysis applies to proportion of treated episodes.||Hypothesis: Rizatriptan will be tolerated as well as placebo with regard to sleepiness/drowsiness||||<0.021
72410129|NCT02447991|144328610|SUPERIORITY||||||<|0.76||||||Significance threshold p\<0.05|Chi-squared, Corrected|This analysis applies to proportion of treated episodes.||Hypothesis: Rizatriptan will be superior to placebo in reducing the severity of vertigo measured by the proportion of treated episodes that subjects rate at grade 1/0 24 hours after taking study medication.||||<0.76
72576436|NCT00658021|144679456|SUPERIORITY||LS Mean Difference|-3.84|STANDARD_ERROR_OF_MEAN|18.542||0.836|TWO_SIDED|95.0|-40.19|32.51|||ANCOVA|||Treatment difference for HOMA-B: Adjusted LS Mean and treatment group difference in the change from baseline values at Week 28 are obtained from multiple imputation ANCOVA including treatment, baseline %HOMA-B, screening HbA1c strata and background diabetes therapy strata as fixed effects.||32.51|-40.19|0.836
72628079|NCT01978145|144784362|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.069||||||95.0|-0.349|0.212|||||The estimated and 95% CI values are presented for Day 56.|||0.212|-0.349|
72628080|NCT01978145|144784362|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.133|||||TWO_SIDED|95.0|-0.413|0.148|||||The estimated and 95% CI values are presented for Day 85.|||0.148|-0.413|
72628081|NCT01978145|144784363|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.24|||||TWO_SIDED|95.0|-0.7|1.19||||||||1.19|-0.70|
72628082|NCT01978145|144784364|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.6|||||TWO_SIDED|95.0|-1.1|-0.02||||||||-0.02|-1.10|
72410130|NCT02447991|144328611|SUPERIORITY||||||<|0.041||||||Significance threshold p \< 0.05|Chi-squared, Corrected|This analysis applies to proportion of treated episodes.||Hypothesis: Rizatriptan will be superior to placebo in reducing the severity of unsteadiness/dizziness episodes measured by the proportion of treated episodes that subjects rate at grade 1/0 24 hours after taking study medication.||||<0.041
72410131|NCT02447991|144328612|SUPERIORITY||||||<|0.12||||||Significance threshold p\<0.05|Chi-squared, Corrected|This analysis applies to proportion of treated episodes.||Hypothesis: Rizatriptan will be superior to placebo in reducing the severity of headaches measured by the proportion of treated episodes that subjects rate at grade 1/0 24 hours after taking study medication.||||<0.12
72410132|NCT02447991|144328613|SUPERIORITY||||||<|0.051||||||Significance threshold p\<0.05|Chi-squared, Corrected|This analysis applies to proportion of treated episodes.||Hypothesis: Rizatriptan will be superior to placebo in reducing the severity of photophobia/phonophobia measured by the proportion of treated episodes that subjects rate at grade 1/0 24 hours after taking study medication.||||<0.051
72410133|NCT02447991|144328614|SUPERIORITY||||||<|0.006||||||Significance threshold p\<0.05|Chi-squared, Corrected|This analysis applies to proportion of treated episodes.||Hypothesis: Rizatriptan will be superior to placebo in reducing the severity of sensitivity to motion measured by the proportion of treated episodes that subjects rate at grade 1/0 24 hours after taking study medication.||||<0.006
72410134|NCT02447991|144328615|SUPERIORITY||||||<|0.67||||||Significance threshold p\<0.05|Chi-squared, Corrected|This analysis applies to proportion of treated episodes.||Hypothesis: Rizatriptan will be superior to placebo in reducing the severity of nausea/vomiting measured by the proportion of treated episodes that subjects rate at grade 1/0 24 hours after taking study medication.||||<0.67
72410135|NCT00459134|144328616|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.66|STANDARD_ERROR_OF_MEAN|1.19||0.576|TWO_SIDED|95.0|-1.67|3.0||This p-value is not adjusted for multiple comparisons.|Mixed Models Analysis|Mixed effect repeated measures model constrained such that the baseline means were equal in the two groups.||The null hypothesis is that sexual function will be the same in both groups at 12 weeks. A Mixed effect repeated measures model constrained such that the baseline means were equal in the two groups was used to test this hypothesis.||3.00|-1.67|0.576
72542061|NCT03593772|144613874|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|0.00132|STANDARD_ERROR_OF_MEAN|0.01039||0.8991|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on Total RDAS as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.8991
72542062|NCT03593772|144613874|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|0.002105|STANDARD_ERROR_OF_MEAN|0.002349||0.3711|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on Decision Making Subdomain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.3711
72542063|NCT03593772|144613874|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|0.001864|STANDARD_ERROR_OF_MEAN|0.002348||0.428|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on Values Subdomain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.4280
72576437|NCT00658021|144679456|SUPERIORITY||LS Mean Difference|-0.28|STANDARD_ERROR_OF_MEAN|3.846||0.941|TWO_SIDED|95.0|-7.82|7.26|||ANCOVA|||Treatment difference for HOMA-S: Adjusted LS Mean and treatment group difference in the change from baseline values at Week 28 are obtained from multiple imputation ANCOVA including treatment, baseline %HOMA-S, screening HbA1c strata and background diabetes therapy strata as fixed effects.||7.26|-7.82|0.941
72576438|NCT00270855|144679474|NON_INFERIORITY_OR_EQUIVALENCE|A Wilcoxon signed-rank test was performed.|||||>|0.05|||||||t-test, 2 sided|||We evaluated differences between baseline and following the 16-week exercise intervention in the ACE group (i.e, baseline vs. post-intervention in ARE)||||>0.05
72576439|NCT00270855|144679474|NON_INFERIORITY_OR_EQUIVALENCE|A Wilcoxon signed-rank test was performed.|||||>|0.05|||||||t-test, 2 sided|||We evaluated differences between baseline and following the 16-week exercise intervention in the FESLCE group (i.e, baseline vs. post-intervention in FESLCE)||||>0.05
72576440|NCT00270855|144679475|NON_INFERIORITY_OR_EQUIVALENCE|A Wilcoxon signed-rank test was performed.|||||>|0.05|||||||t-test, 2 sided|||We evaluated differences between baseline and following the 16-week exercise intervention in the ACE group||||>0.05
72410136|NCT00459134|144328617|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.49|STANDARD_ERROR_OF_MEAN|1.73||0.01|TWO_SIDED|95.0|1.09|7.89||This p-value is not adjusted for multiple comparisons.|Mixed Models Analysis|Mixed effect repeated measures model constrained such that the baseline means were equal in the two groups.||The null hypothesis was that quality of life would be the same in both groups at 12 weeks. A mixed effect repeated measures model constrained such that the baseline means were equal in the two groups was used to test this hypothesis.||7.89|1.09|0.010
72410137|NCT00672477|144328659|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||< 0.0001
72576441|NCT00270855|144679475|NON_INFERIORITY_OR_EQUIVALENCE|A Wilcoxon signed-rank test was performed.|||||>|0.05|||||||t-test, 2 sided|||We evaluated differences between baseline and following the 16-week exercise intervention in the FESLCE group||||>0.05
72410138|NCT00672477|144328660|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Log Rank|||||||< 0.0001
72410139|NCT02057757|144328676|EQUIVALENCE|The equivalence margin is 1.25 Days.||||||0.5634|||||||Fay - Shaw|||||||0.5634
72628083|NCT02777086|144784380|SUPERIORITY||||||<|0.001|||||||ANCOVA|||3-month outcome measures were compared between the StaySafe and Comparison groups controlling for the baseline measure using generalized linear models.||||<.001
72628084|NCT01732536|144784386|SUPERIORITY|||||||0.1365|||||||ANCOVA|Based on between group comparison using ANCOVA model with baseline as a covariate and site and treatment as fixed effects||||||0.1365
72628085|NCT01732536|144784386|SUPERIORITY|||||||0.0505||||||Based on between group comparison using ANCOVA model with baseline as a covariate and site and treatment as fixed effects|ANCOVA|||The change from baseline to Day 90 in Nasal Obstruction/Congestion score in the subset of participants with higher polyp burden at baseline (grade 2 or higher polyps on each side; N=67).||||0.0505
72628086|NCT01732536|144784387|SUPERIORITY|||||||0.0985|||||||ANCOVA|Based on ANCOVA model with baseline as a covariate, site and treatment as fixed effect||||||0.0985
72628087|NCT01732536|144784387|SUPERIORITY|||||||0.049|||||||ANOVA|Based on ANCOVA model with baseline as a covariate, site and treatment as fixed effect||Bilateral polyp grade change in a subset of 67 patients with higher polyp burden at baseline (grade 2 or higher on each side confirmed by the independent panel)||||0.0490
72410140|NCT02057757|144328677|SUPERIORITY|||||||0.645||||||The p-value for each time point was calculated; Day 3|Fay - Shaw|||||||0.645
72410141|NCT02057757|144328677|SUPERIORITY|||||||0.989||||||The p-value for each value was calculated (Day 7).|Fay-Shaw|||||||0.989
72410142|NCT02057757|144328677|SUPERIORITY|||||||0.809||||||Day 14|Fay-Shaw|||||||0.809
72628088|NCT01732536|144784388|SUPERIORITY|||||||0.0099|||||||ANCOVA|||||||0.0099
72410143|NCT02057757|144328677|SUPERIORITY|||||||0.671||||||Day 28|Fay-Shaw|||||||0.671
72410144|NCT02057757|144328679|SUPERIORITY|||||||0.4277||||||Cough|Fay - Shaw|||||||0.4277
72410145|NCT02057757|144328679|SUPERIORITY|||||||0.4022||||||Sore Throat|Fay-Shaw|||||||0.4022
72410146|NCT02057757|144328679|SUPERIORITY|||||||0.5957||||||Fatigue|Fay-Shaw|||||||0.5957
72410147|NCT02057757|144328679|SUPERIORITY|||||||0.0446||||||Nasal Discharge|Fay-Shaw|||||||0.0446
72410148|NCT02057757|144328679|SUPERIORITY|||||||0.8628||||||Difficulty Breathing|Fay-Shaw|||||||0.8628
72410149|NCT02057757|144328679|SUPERIORITY|||||||0.16||||||Headache|Fay-Shaw|||||||0.16
72410150|NCT02057757|144328679|SUPERIORITY|||||||0.1234||||||Muscle Pain|Fay-Shaw|||||||0.1234
72410151|NCT02057757|144328679|SUPERIORITY|||||||0.2155||||||Nausea|Fay-Shaw|||||||0.2155
72410152|NCT02057757|144328679|SUPERIORITY|||||||0.5176||||||Vomiting|Fay-Shaw|||||||0.5176
72410153|NCT02057757|144328679|SUPERIORITY|||||||0.6986||||||Diarrhea|Fay-Shaw|||||||0.6986
72410154|NCT02057757|144328680|SUPERIORITY|||||||0.985|||||||Fay - Shaw|||||||0.9850
72410155|NCT02057757|144328681|SUPERIORITY|||||||0.681||||||Any Time|Fay - Shaw|||||||0.681
72410156|NCT02057757|144328681|SUPERIORITY|||||||0.341||||||Day 0|Fay-Shaw|||||||0.341
72410157|NCT02057757|144328681|SUPERIORITY|||||||0.321||||||Day 3|Fay-Shaw|||||||0.321
72410158|NCT02057757|144328681|SUPERIORITY|||||||0.957||||||Day 7|Fay-Shaw|||||||0.957
72410159|NCT02057757|144328681|SUPERIORITY|||||||0.788||||||Day 14|Fay-Shaw|||||||0.788
72410160|NCT02057757|144328681|SUPERIORITY|||||||0.544||||||Day 28|Fay-Shaw|||||||0.544
72410161|NCT02057757|144328682|SUPERIORITY|||||||0.671||||||Any Time|Fay - Shaw|||||||0.671
72410162|NCT02057757|144328682|SUPERIORITY|||||||0.325||||||Day 0|Fay-Shaw|||||||0.325
72410163|NCT02057757|144328682|SUPERIORITY|||||||0.987||||||Day 3|Fay-Shaw|||||||0.987
72410164|NCT02057757|144328682|SUPERIORITY|||||||0.987||||||Day 7|Fay-Shaw|||||||0.987
72628089|NCT01732536|144784389|SUPERIORITY|||||||0.0162||||||P-value for change from baseline to 90 days not adjusted for multiplicity|ANCOVA|ANCOVA model with baseline as a covariate and site and treatment as fixed effects||||||0.0162
72628090|NCT01732536|144784389|SUPERIORITY|||||||0.0175||||||P-value for change from baseline to 6 months not adjusted for multiplicity|ANCOVA|ANCOVA model with baseline as a covariate and site and treatment as fixed effects||||||0.0175
72628091|NCT01732536|144784390|SUPERIORITY|||||||0.0209||||||P-value not adjusted for multiplicity.|ANCOVA|Based on between arm comparison using ANCOVA model with baseline as a covariate and site and treatment as fixed effects||||||0.0209
72628092|NCT02122380|144784392|SUPERIORITY|||||||0.918|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in change of mean growth hormone (GH) levels between sitagliptin and placebo. The test was performed with a significance level of 0.05 (two sided). A sample size of 16 participants was needed to provide 93% power to detect a difference in GH means of 0.5 mcg/L.||||0.918
72628093|NCT02122380|144784393|SUPERIORITY|||||||0.054|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in change of early insulin secretion between sitagliptin and placebo. The test was performed with a significance level of 0.05 (two sided).||||0.054
72628094|NCT02122380|144784394|SUPERIORITY|||||||0.009|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in blood glucose levels between sitagliptin and placebo. The test was performed with a significance level of 0.05 (two sided).||||0.009
72628095|NCT02122380|144784395|SUPERIORITY|||||||0.022|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in the mass of visceral adipose tissue after sitagliptin vs. placebo. The test was performed with a significance level of 0.05 (two sided).||||0.022
72628096|NCT02122380|144784396|SUPERIORITY|||||||0.943|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in vascular function between sitagliptin and placebo treatments. The test was performed with a significance level of 0.05 (two sided).||||0.943
72628097|NCT03235050|144784442|SUPERIORITY||LS Mean Difference|-0.83|||<|0.001|TWO_SIDED|95.0|-1.06|-0.59|||ANCOVA|||||-0.59|-1.06|<0.001
72628098|NCT03235050|144784442|SUPERIORITY||LS Mean Difference|-1.04|||<|0.001|TWO_SIDED|95.0|-1.23|-0.85|||ANCOVA|||||-0.85|-1.23|<0.001
72628099|NCT03235050|144784442|SUPERIORITY||LS Mean Difference|-0.91|||<|0.001|TWO_SIDED|95.0|-1.11|-0.72|||ANCOVA|||||-0.72|-1.11|<0.001
72410165|NCT02057757|144328682|SUPERIORITY|||||||0.311||||||Day 14|Fay-Shaw|||||||0.311
72410166|NCT02057757|144328683|SUPERIORITY|||||||0.973||||||Any Time|Fay - Shaw|||||||0.973
72542064|NCT03593772|144613874|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|-0.00007|STANDARD_ERROR_OF_MEAN|0.003205||0.9831|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on Affection Subdomain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.9831
72410167|NCT02057757|144328683|SUPERIORITY|||||||0.575||||||Day 0|Fay-Shaw|||||||0.575
72410168|NCT02057757|144328683|SUPERIORITY|||||||0.548||||||Day 3|Fay-Shaw|||||||0.548
72410169|NCT02057757|144328683|SUPERIORITY|||||||0.987||||||Day 7|Fay-Shaw|||||||0.987
72542065|NCT03593772|144613874|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|0.003052|STANDARD_ERROR_OF_MEAN|0.006364||0.632|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on Total Consensus Domain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.6320
72542066|NCT03593772|144613874|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|0.00007|STANDARD_ERROR_OF_MEAN|0.002259||0.9755|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on Stability Subdomain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.9755
72542067|NCT03593772|144613874|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|0.00056|STANDARD_ERROR_OF_MEAN|0.001818||0.7584|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on Conflict Subdomain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.7584
72542068|NCT03593772|144613874|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|0.000297|STANDARD_ERROR_OF_MEAN|0.003444||0.9313|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on Total Satisfaction Domain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.9313
72542069|NCT03593772|144613874|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|-0.00129|STANDARD_ERROR_OF_MEAN|0.002097||0.5401|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on Activities Subdomain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.5401
72542070|NCT03593772|144613874|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|0.00018|STANDARD_ERROR_OF_MEAN|0.002471||0.9421|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on Discussion Subdomain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.9421
72576442|NCT00270855|144679476|NON_INFERIORITY_OR_EQUIVALENCE|A Wilcoxon signed-rank test was performed.||||||0.519|||||||t-test, 2 sided|||We evaluated differences between baseline and following the 16-week exercise intervention in the ACE group.||||0.519
72410170|NCT02057757|144328683|SUPERIORITY|||||||0.987||||||Day 14|Fay-Shaw|||||||0.987
72410171|NCT02057757|144328683|SUPERIORITY|||||||0.987||||||Day 28|Fay-Shaw|||||||0.987
72410172|NCT02057757|144328684|SUPERIORITY|||||||0.928||||||Pneumonia|Fay - Shaw|||||||0.928
72410173|NCT02057757|144328684|SUPERIORITY|||||||0.9669||||||ARDS|Fay-Shaw|||||||0.9669
72410174|NCT02057757|144328684|SUPERIORITY|||||||0.0832||||||Bronchitis|Fay-Shaw|||||||0.0832
72410175|NCT02057757|144328685|SUPERIORITY|||||||0.036||||||Adults (\>= 18 Years ) - Global Assessment: Have you felt as good as you did before you had the respiratory illness?|Fay - Shaw|||||||0.0360
72410176|NCT02057757|144328685|SUPERIORITY|||||||0.038||||||Adults (\>= 18 Years) - Global Assessment: Are you functioning as well as you were before you had the respiratory illness?|Fay-Shaw|||||||0.0380
72410177|NCT02057757|144328685|SUPERIORITY|||||||0.5035||||||Children (\< 18 Years) - Global Assessment: Have you/your child felt as good as you did before you had the respiratory illness?|Fay-Shaw|||||||0.5035
72410178|NCT02057757|144328685|SUPERIORITY|||||||0.9231||||||Children (\<18 Years) - Global Assessment: Are you/your child functioning as well as you/your child were before you/your child had the respiratory illness?|Fay-Shaw|||||||0.9231
72410179|NCT02057757|144328689|SUPERIORITY|||||||0.9785||||||No Detectable Virus on Day 3|Fay-Shaw|||||||0.9785
72542071|NCT03593772|144613874|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|-0.00151|STANDARD_ERROR_OF_MEAN|0.003983||0.7042|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on Total Cohesion Domain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.7042
72542072|NCT03593772|144613874|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|0.02128|STANDARD_ERROR_OF_MEAN|0.008331||0.0114|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on Total RDAS Score as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.0114
72542073|NCT03593772|144613874|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|0.002587|STANDARD_ERROR_OF_MEAN|0.001727||0.1358|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on Decision Making Subdomain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.1358
72576443|NCT00270855|144679476|NON_INFERIORITY_OR_EQUIVALENCE|A Wilcoxon signed-rank test was performed.|||||>|0.05|||||||t-test, 2 sided|||We evaluated differences between baseline and following the 16-week exercise intervention in the FESLCE group||||>0.05
72576444|NCT00270855|144679477|NON_INFERIORITY_OR_EQUIVALENCE|A Wilcoxon signed-rank test was performed.||||||0.615|||||||t-test, 2 sided|||We evaluated differences between baseline and following the 16-week exercise intervention in the ACE group||||0.615
72576445|NCT00270855|144679477|NON_INFERIORITY_OR_EQUIVALENCE|A Wilcoxon signed-rank test was performed.|||||>|0.05|||||||t-test, 2 sided|||We evaluated differences between baseline and following the 16-week exercise intervention in the FESLCE group||||>0.05
72576446|NCT00270855|144679478|NON_INFERIORITY_OR_EQUIVALENCE|A Wilcoxon signed-rank test was performed.|||||>|0.05|||||||t-test, 2 sided|||We evaluated differences between baseline and following the 16-week exercise intervention in the ACE group||||>0.05
72576447|NCT00270855|144679478|NON_INFERIORITY_OR_EQUIVALENCE|A Wilcoxon signed-rank test was performed.|||||>|0.05|||||||t-test, 2 sided|||We evaluated differences between baseline and following the 16-week exercise intervention in the FESLCE group||||>0.05
72576448|NCT00270855|144679479|NON_INFERIORITY_OR_EQUIVALENCE|A Mann-Whitney-u test was performed.|||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||We evaluated differences in the above variable between the ACE and FESLCE following the the 16-week exercise intervention||||>0.05
72576449|NCT00270855|144679480|NON_INFERIORITY_OR_EQUIVALENCE|A Mann-Whitney-u test was performed.|||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||We evaluated differences in the above variable between the ACE and FESLCE following the the 16-week exercise intervention||||>0.05
72576450|NCT00270855|144679481|NON_INFERIORITY_OR_EQUIVALENCE|A Mann-Whitney-u test was performed.|||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||We evaluated differences in the above variable between the ACE and FESLCE following the the 16-week exercise intervention||||>0.05
72576451|NCT00270855|144679482|NON_INFERIORITY_OR_EQUIVALENCE|A Mann-Whitney-u test was performed.|||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||We evaluated differences in the above variable between the ACE and FESLCE following the the 16-week exercise intervention||||>0.05
72576452|NCT00270855|144679483|NON_INFERIORITY_OR_EQUIVALENCE|A Mann-Whitney-u test was performed|||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||We evaluated differences in the above variable between the ACE and FESLCE following the the 16-week exercise intervention||||>0.05
72576453|NCT00270855|144679484|NON_INFERIORITY_OR_EQUIVALENCE|A Wilcoxon signed-rank test was performed.|||||>|0.05|||||||t-test, 2 sided|||We evaluated differences between baseline and following the 16-week exercise intervention in the ACE group||||>0.05
72410180|NCT00456092|144328726|SUPERIORITY||Odds Ratio (OR)|4.19||||0.002|TWO_SIDED|95.0|1.72|10.2||A p-value \< 0.025 (2-sided) is considered statistically significant, after adjusting for two treatment comparisons using the Bonferroni procedure.|Chi-squared, Corrected|||||10.20|1.72|0.002
72576454|NCT00270855|144679484|NON_INFERIORITY_OR_EQUIVALENCE|A Wilcoxon signed-rank test was performed.|||||>|0.05|||||||t-test, 2 sided|||We evaluated differences between baseline and following the 16-week exercise intervention in the FESLCE group||||>0.05
72576455|NCT00270855|144679485|NON_INFERIORITY_OR_EQUIVALENCE|A Wilcoxon signed-rank test was performed.|||||>|0.05|||||||t-test, 2 sided|||We evaluated differences between baseline and following the 16-week exercise intervention in the ACE group||||>0.05
72576456|NCT00270855|144679485|NON_INFERIORITY_OR_EQUIVALENCE|A Wilcoxon signed-rank test was performed.|||||>|0.05|||||||t-test, 2 sided|||We evaluated differences between baseline and following the 16-week exercise intervention in the FESLCE group||||>0.05
72576457|NCT00270855|144679486|NON_INFERIORITY_OR_EQUIVALENCE|Wilcoxon signed-rank test was performed|||||>|0.05|||||||t-test, 2 sided|||We evaluated differences between baseline and following the 16-week exercise intervention in the ACE group||||>0.05
72576458|NCT00270855|144679486|NON_INFERIORITY_OR_EQUIVALENCE|A Wilcoxon signed-rank test was performed.|||||>|0.05|||||||t-test, 2 sided|||We evaluated differences between baseline and following the 16-week exercise intervention in the FESLCE group||||>0.05
72576459|NCT00270855|144679487|NON_INFERIORITY_OR_EQUIVALENCE|A Wilcoxon signed-rank test was performed|||||>|0.05|||||||t-test, 2 sided|||We evaluated differences between baseline and following the 16-week exercise intervention in the ACE group||||>0.05
72576460|NCT00270855|144679487|NON_INFERIORITY_OR_EQUIVALENCE|A Wilcoxon signed-rank test was performed.|||||>|0.05|||||||t-test, 2 sided|||We evaluated differences between baseline and following the 16-week exercise intervention in the FESLCE group||||>0.05
72576461|NCT00270855|144679488|NON_INFERIORITY_OR_EQUIVALENCE|A Wilcoxon signed-rank test was performed|||||>|0.05|||||||t-test, 2 sided|||We evaluated differences between baseline and following the 16-week exercise intervention in the ACE group||||>0.05
72542074|NCT03593772|144613874|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|0.001402|STANDARD_ERROR_OF_MEAN|0.001796||0.4354|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on Values Subdomain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.4354
72542075|NCT03593772|144613874|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|0.005759|STANDARD_ERROR_OF_MEAN|0.002113||0.007|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on AffectionSubdomain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.0070
72410181|NCT00456092|144328726|SUPERIORITY||Odds Ratio (OR)|5.77|||<|0.001|TWO_SIDED|95.0|2.4|13.88||A p-value \< 0.025 (2-sided) is considered statistically significant, after adjusting for two treatment comparisons using the Bonferroni procedure.|Chi-squared, Corrected|||||13.88|2.40|< 0.001
72410182|NCT00456092|144328729|SUPERIORITY||Odds Ratio (OR)|5.12||||0.056|TWO_SIDED|95.0|1.06|24.67|||Chi-squared, Corrected|||||24.67|1.06|0.056
72576462|NCT00270855|144679488|NON_INFERIORITY_OR_EQUIVALENCE|A Wilcoxon signed-rank test was performed.|||||>|0.05|||||||t-test, 2 sided|||We evaluated differences between baseline and following the 16-week exercise intervention in the FESLCE group||||>0.05
72576463|NCT00270855|144679489|NON_INFERIORITY_OR_EQUIVALENCE|A Wilcoxon signed-rank test was performed|||||>|0.05|||||||t-test, 2 sided|||We evaluated differences between baseline and following the 16-week exercise intervention in the ACE group||||>0.05
72576464|NCT00270855|144679489|NON_INFERIORITY_OR_EQUIVALENCE|A Wilcoxon signed-rank test was performed.|||||>|0.05|||||||t-test, 2 sided|||We evaluated differences between baseline and following the 16-week exercise intervention in the FESLCE group||||>0.05
72576465|NCT00270855|144679490|NON_INFERIORITY_OR_EQUIVALENCE|A Wilcoxon signed-rank test was performed|||||>|0.05|||||||t-test, 2 sided|||We evaluated differences between baseline and following the 16-week exercise intervention in the ACE group||||>0.05
72576466|NCT00270855|144679490|NON_INFERIORITY_OR_EQUIVALENCE|A Wilcoxon signed-rank test was performed.|||||>|0.05|||||||t-test, 2 sided|||We evaluated differences between baseline and following the 16-week exercise intervention in the FESLCE group||||>0.05
72576467|NCT00270855|144679491|NON_INFERIORITY_OR_EQUIVALENCE|A Mann-Whitney-u test was performed.|||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||We evaluated differences in the above variable between the ACE and FESLCE following the the 16-week exercise intervention||||>0.05
72576468|NCT00270855|144679492|NON_INFERIORITY_OR_EQUIVALENCE|A Mann-Whitney-u test was performed|||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||We evaluated differences in the above variable between the ACE and FESLCE following the the 16-week exercise intervention||||>0.05
72576469|NCT00270855|144679493|NON_INFERIORITY_OR_EQUIVALENCE|A Mann-Whitney-u test was performed|||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||We evaluated differences in the above variable between the ACE and FESLCE following the the 16-week exercise intervention||||>0.05
72576470|NCT00270855|144679494|NON_INFERIORITY_OR_EQUIVALENCE|A Mann-Whitney-u test was performed|||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||We evaluated differences in the above variable between the ACE and FESLCE following the the 16-week exercise intervention||||>0.05
72576471|NCT00270855|144679495|OTHER|A Mann-Whitney U test was performed.|||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||We evaluated differences in the above variable between the ACE and FESLCE following the the 16-week exercise intervention||||>0.05
72576472|NCT00270855|144679496|NON_INFERIORITY_OR_EQUIVALENCE|We used a Mann-Whitney U test.|||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||we evaluated differences in the above variable between the ACE and FESLCE following the the 16-week exercise intervention||||>0.05
72576473|NCT00270855|144679497|NON_INFERIORITY_OR_EQUIVALENCE|A mann-whitney u test was performed.|||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||We evaluated differences in the above variable between the ACE and FESLCE following the the 16-week exercise intervention||||>0.05
72576474|NCT00270855|144679498|NON_INFERIORITY_OR_EQUIVALENCE|A Wilcoxon signed-rank test was performed.|||||>|0.05|||||||t-test, 2 sided|||We evaluated differences between baseline and following the 16-week exercise intervention in the ACE group||||>0.05
72576475|NCT00270855|144679498|NON_INFERIORITY_OR_EQUIVALENCE|A Wilcoxon signed-rank test was performed.|||||>|0.05|||||||t-test, 2 sided|||We evaluated differences between baseline and following the 16-week exercise intervention in the FESLCE group||||>0.05
72576476|NCT00270855|144679499|NON_INFERIORITY_OR_EQUIVALENCE|A Mann-Whitney U test was performed.|||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||We evaluated differences in the above variable between the ACE and FESLCE following the the 16-week exercise intervention||||>0.05
72576477|NCT02755649|144679522|SUPERIORITY||Difference in Percentages|29.5|||<|0.0001|TWO_SIDED|95.0|16.87|42.05||Threshold for significance at 0.05 level. P-values were derived by Cochran-Mantel-Haenszel (CMH) test stratified by disease severity (IGA 3 vs IGA 4) and prior Cyclosporine A (CSA) use (Yes, No).|Cochran-Mantel-Haenszel|||A hierarchical testing approach was used to control Type-1 error at 0.05 across 2 dose regimens. Difference is Dupilumab minus placebo. Confidence Interval (CI) calculated using normal approximation. Participants with missing values at Week 16 were categorized as non-responders at Week 16. Participants who used rescue treatment were categorized as non-responders from time rescue treatment was initiated.||42.05|16.87|< 0.0001
72576478|NCT02755649|144679522|SUPERIORITY||difference in percentages|33.0|||<|0.0001|TWO_SIDED|95.0|20.41|45.57||Threshold for significance at 0.05 level. P-values were derived by Cochran-Mantel-Haenszel (CMH) test stratified by disease severity (IGA 3 vs IGA 4) and prior Cyclosporine A (CSA) use (Yes, No).|Cochran-Mantel-Haenszel|||A hierarchical testing approach was used to control Type-1 error at 0.05 across 2 dose regimens. Difference is Dupilumab minus placebo. Confidence Interval (CI) calculated using normal approximation. Participants with missing values at Week 16 were categorized as non-responders at Week 16. Participants who used rescue treatment were categorized as non-responders from time rescue treatment was initiated.||45.57|20.41|< 0.0001
72628100|NCT03235050|144784443|SUPERIORITY||LS Mean Difference|-2.0|||<|0.001|TWO_SIDED|95.0|-3.08|-0.91|||ANCOVA|||||-0.91|-3.08|<0.001
72369108|NCT00478023|144248219|SUPERIORITY_OR_OTHER_LEGACY||Least square mean difference|20.8|||<|0.0001||95.0|13.7|28.0||Adjusted. The Hochberg procedure used for multiplicity comparisons|ANCOVA|ANCOVA with treatment and centre as fixed effects and baseline pain as covariate.|Only pain intensity assessments collected prior to the first dose of any additional analgesic medication considered. Afterwards LOCF used.|The null hypothesis is that all CG5503 IR dose groups are equal to the placebo group based on the mean sum of pain intensity difference at 24 hours (SPID24). The alternative hypothesis is that at least one CG5503 IR dose group is different from the placebo group based on the mean SPID24.||28.0|13.7|<0.0001
72410183|NCT00456092|144328729|SUPERIORITY||Odds Ratio (OR)|6.95||||0.012|TWO_SIDED|95.0|1.49|32.35|||Chi-squared, Corrected|||||32.35|1.49|0.012
72576479|NCT02755649|144679523|SUPERIORITY||Least square (LS) mean difference|-31.6|||<|0.0001|TWO_SIDED|95.0|-38.85|-24.3||Threshold for significance at 0.05 level|ANCOVA|||Hierarchical testing approach to control Type-1 error rate at 0.05 across 2 dose regimens.CI w/p-value based on treatment difference(dupilumab vs placebo) of LS mean percent change using multiple imputation (MI) w/ANCOVA model w/baseline measurement as covariate \& treatment, randomization strata(disease severity\[IGA 3 vs IGA 4\] \& prior CSA use\[Yes,No\]) as fixed factors.Efficacy data from participants who received rescue treatment were set to missing after timepoint of rescue, then imputed by MI||-24.3|-38.85|< 0.0001
72576480|NCT02755649|144679523|SUPERIORITY||LS Mean Difference|-33.1|||<|0.0001|TWO_SIDED|95.0|-40.42|-25.88||Threshold for significance at 0.05 level|ANCOVA|||Hierarchical testing approach was used to control Type-1 error rate at 0.05 across 2 dose regimens.CI with p-value based on treatment difference(dupilumab vs. placebo) of LS mean percent change using MI with ANCOVA model with baseline measurement as covariate \& treatment, randomization strata(disease severity\[IGA 3 vs IGA 4\] \& prior CSA use \[Yes,No\]) as fixed factors. Efficacy data from participants who received rescue treatment were set to missing after timepoint of rescue \& then imputed by MI.||-25.88|-40.42|< 0.0001
72576481|NCT02755649|144679524|SUPERIORITY||LS mean difference|-26.2|||<|0.0001|TWO_SIDED|95.0|-35.07|-17.41||Threshold for significance at 0.05 level.|ANCOVA|||Hierarchical testing approach was used to control Type-1 error rate at 0.05 across 2 dose regimens.CI with p-value based on treatment difference(dupilumab vs. placebo) of LS mean percent change using MI with ANCOVA model with baseline measurement as covariate \& treatment, randomization strata(disease severity\[IGA 3 vs IGA 4\] \& prior CSA use \[Yes,No\]) as fixed factors.Efficacy data from participants who received rescue treatment were set to missing after timepoint of rescue, then imputed by MI||-17.41|-35.07|< 0.0001
72628101|NCT03235050|144784443|SUPERIORITY||LS Mean Difference|-2.76|||<|0.001|TWO_SIDED|95.0|-3.65|-1.87|||ANCOVA|||||-1.87|-3.65|<0.001
72628102|NCT03235050|144784443|SUPERIORITY||LS Mean Difference|-3.62|||<|0.001|TWO_SIDED|95.0|-4.51|-2.73|||ANCOVA|||||-2.73|-4.51|<0.001
72410184|NCT00456092|144328730|SUPERIORITY||Odds Ratio (OR)|5.4||||0.204|TWO_SIDED|95.0|0.61|47.54|||Chi-squared, Corrected|||||47.54|0.61|0.204
72410185|NCT00456092|144328730|SUPERIORITY||Odds Ratio (OR)|4.12||||0.371|TWO_SIDED|95.0|0.45|37.88|||Chi-squared, Corrected|||||37.88|0.45|0.371
72628103|NCT03235050|144784444|SUPERIORITY||LS Mean Difference|-0.66|||<|0.001|TWO_SIDED|95.0|-0.92|-0.4|||ANCOVA|||Week 26||-0.40|-0.92|<0.001
72628104|NCT03235050|144784444|SUPERIORITY||LS Mean Difference|-0.81|||<|0.001|TWO_SIDED|95.0|-1.03|-0.6|||ANCOVA|||Week 26||-0.60|-1.03|<0.001
72628105|NCT03235050|144784444|SUPERIORITY||LS Mean Difference|-0.72|||<|0.001|TWO_SIDED|95.0|-0.94|-0.51|||ANCOVA|||Week 26||-0.51|-0.94|<0.001
72628106|NCT03235050|144784444|SUPERIORITY||LS Mean Difference|-0.52|||<|0.001|TWO_SIDED|95.0|-0.8|-0.24|||ANCOVA|||Week 54||-0.24|-0.80|<0.001
72628107|NCT03235050|144784444|SUPERIORITY||LS Mean Difference|-0.63|||<|0.001|TWO_SIDED|95.0|-0.86|-0.39|||ANCOVA|||Week 54||-0.39|-0.86|<0.001
72628108|NCT03235050|144784444|SUPERIORITY||LS Mean Difference|-0.57|||<|0.001|TWO_SIDED|95.0|-0.8|-0.34|||ANCOVA|||Week 54||-0.34|-0.80|<0.001
72628109|NCT03235050|144784445|SUPERIORITY||Odds Ratio, log|6.67|||<|0.001|TWO_SIDED|92.0|3.34|13.3|||Regression, Logistic|||Week 14||13.30|3.34|<0.001
72628110|NCT03235050|144784445|SUPERIORITY||Odds Ratio, log|9.95|||<|0.001|TWO_SIDED|95.0|5.39|18.36|||Regression, Logistic|||Week 14||18.36|5.39|<0.001
72628111|NCT03235050|144784445|SUPERIORITY||Odds Ratio, log|8.52|||<|0.001|TWO_SIDED|95.0|4.65|15.61|||Regression, Logistic|||Week 14||15.61|4.65|<0.001
72628112|NCT03235050|144784445|SUPERIORITY||Odds Ratio, log|3.74|||<|0.001|TWO_SIDED|95.0|1.98|7.03|||Regression, Logistic|||Week 26||7.03|1.98|<0.001
72628113|NCT03235050|144784445|SUPERIORITY||Odds Ratio, log|5.4|||<|0.001|TWO_SIDED|95.0|3.13|9.34|||Regression, Logistic|||Week 26||9.34|3.13|<0.001
72628114|NCT03235050|144784445|SUPERIORITY||Odds Ratio, log|5.2|||<|0.001|TWO_SIDED|95.0|3.02|8.97|||Regression, Logistic|||Week 26||8.97|3.02|<0.001
72628115|NCT03235050|144784445|SUPERIORITY||Odds Ratio, log|4.94|||<|0.001|TWO_SIDED|95.0|2.61|9.36|||Regression, Logistic|||Week 54||9.36|2.61|<0.001
72628116|NCT03235050|144784445|SUPERIORITY||Odds Ratio, log|4.55|||<|0.001|TWO_SIDED|95.0|2.62|7.89|||Regression, Logistic|||Week 54||7.89|2.62|<0.001
72628117|NCT03235050|144784445|SUPERIORITY||Odds Ratio, log|4.34|||<|0.001|TWO_SIDED|95.0|2.51|7.51|||Regression, Logistic|||Week 54||7.51|2.51|<0.001
72628118|NCT03235050|144784446|SUPERIORITY||LS Mean Difference|-2.09|||<|0.001|TWO_SIDED|95.0|-3.32|-0.85|||ANCOVA|||Week 26||-0.85|-3.32|<0.001
72628119|NCT03235050|144784446|SUPERIORITY||LS Mean Difference|-2.8|||<|0.001|TWO_SIDED|95.0|-3.82|-1.79|||ANCOVA|||Week 26||-1.79|-3.82|<0.001
72628120|NCT03235050|144784446|SUPERIORITY||LS Mean Difference|-3.46|||<|0.001|TWO_SIDED|95.0|-4.48|-2.44|||ANCOVA|||Week 26||-2.44|-4.48|<0.001
72628121|NCT03235050|144784446|SUPERIORITY||LS Mean Difference|-2.43|||<|0.001|TWO_SIDED|95.0|-3.86|-1.0|||ANCOVA|||Week 54||-1.00|-3.86|<0.001
72628122|NCT03235050|144784446|SUPERIORITY||LS Mean Difference|-2.24|||<|0.001|TWO_SIDED|95.0|-3.41|-1.06|||ANCOVA|||Week 54||-1.06|-3.41|<0.001
72628123|NCT03235050|144784446|SUPERIORITY||LS Mean Difference|-3.32|||<|0.001|TWO_SIDED|95.0|-4.49|-2.14|||ANCOVA|||Week 54||-2.14|-4.49|<0.001
72628124|NCT03235050|144784447|SUPERIORITY||LS Mean Difference|-1.95|||<|0.001|TWO_SIDED|95.0|-3.03|-0.87|||ANCOVA|||Week 14||-0.87|-3.03|<0.001
72628125|NCT03235050|144784447|SUPERIORITY||LS Mean Difference|-2.75|||<|0.001|TWO_SIDED|95.0|-3.63|-1.86|||ANCOVA|||Week 14||-1.86|-3.63|<0.001
72628126|NCT03235050|144784447|SUPERIORITY||LS Mean Difference|-3.71|||<|0.001|TWO_SIDED|95.0|-4.6|-2.82|||ANCOVA|||Week 14||-2.82|-4.60|<0.001
72542076|NCT03593772|144613874|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|0.01037|STANDARD_ERROR_OF_MEAN|0.004485||0.0217|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on Total Consensus Domain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.0217
72542077|NCT03593772|144613874|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|-0.00039|STANDARD_ERROR_OF_MEAN|0.001461||0.7881|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on Stability Subdomain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.7881
72542078|NCT03593772|144613874|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|0.004717|STANDARD_ERROR_OF_MEAN|0.00141||0.001|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on Conflict Subdomain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.0010
72542079|NCT03593772|144613874|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|0.004393|STANDARD_ERROR_OF_MEAN|0.002415||0.0693|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on Total Satisfaction Domain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.0693
72542080|NCT03593772|144613874|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|0.002959|STANDARD_ERROR_OF_MEAN|0.001887||0.1184|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on Activities Subdomain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.1184
72542081|NCT03593772|144613874|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|0.003436|STANDARD_ERROR_OF_MEAN|0.002262||0.1301|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on Discussion Subdomain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.1301
72542082|NCT03593772|144613874|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|0.006022|STANDARD_ERROR_OF_MEAN|0.003697||0.1049|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on Total Cohesion Domain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.1049
72542083|NCT05788237|144613910|OTHER||GMR|0.84|||||TWO_SIDED|95.0|0.662|1.062||||||GMR for RSV A: RSVpreF + qIRV combination to RSVpreF alone.||1.062|0.662|
72542084|NCT05788237|144613910|OTHER||GMR|0.79|||||TWO_SIDED|95.0|0.614|1.013||||||GMR for RSV B: RSVpreF + qIRV combination to RSVpreF alone.||1.013|0.614|
72542085|NCT05788237|144613911|OTHER||GMR|0.81|||||TWO_SIDED|95.0|0.632|1.044||||||GMR for HAI: H1N1 A/Wisconsin: RSVpreF + qIRV combination to RSVpreF alone.||1.044|0.632|
72628127|NCT03235050|144784447|SUPERIORITY||LS Mean Difference|-2.01||||0.002|TWO_SIDED|95.0|-3.27|-0.74|||ANCOVA|||Week 26||-0.74|-3.27|0.002
72542086|NCT05788237|144613911|OTHER||Geometric Mean Ratio|0.74|||||TWO_SIDED|95.0|0.567|0.957||||||GMR for HAI: H3N2 A/Darwin: RSVpreF + qIRV combination to RSVpreF alone.||0.957|0.567|
72542087|NCT05788237|144613911|OTHER||GMR|0.94|||||TWO_SIDED|95.0|0.741|1.181||||||GMR for HAI: B/Austria: RSVpreF + qIRV combination to RSVpreF alone.||1.181|0.741|
72542088|NCT05788237|144613911|OTHER||GMR|0.91|||||TWO_SIDED|95.0|0.707|1.174||||||GMR for HAI: B/Phuket: RSVpreF + qIRV combination to RSVpreF alone.||1.174|0.707|
72542089|NCT05788237|144613912|OTHER||Geometric Mean Ratio|1.05|||||TWO_SIDED|95.0|0.82|1.339||||||GMR for RSV A: RSVpreF + qIRV 1.0 mL (Group 1) combination to RSVpreF + qIRV 0.5 mL (Group 2)||1.339|0.820|
72542090|NCT05788237|144613912|OTHER||Geometric Mean Ratio|1.06|||||TWO_SIDED|95.0|0.833|1.352||||||GMR for RSV B: RSVpreF + qIRV 1.0 mL (Group 1) to RSVpreF + qIRV 0.5 mL (Group 2)||1.352|0.833|
72542091|NCT05788237|144613913|OTHER||GMR|1.19|||||TWO_SIDED|95.0|0.875|1.614||||||GMR for HAI: H1N1 A/Sydney: RSVpreF + qIRV 1.0 mL (Group 1) to RSVpreF + qIRV 0.5 mL (Group 2)||1.614|0.875|
72628128|NCT03235050|144784447|SUPERIORITY||LS Mean Difference|-2.74|||<|0.001|TWO_SIDED|95.0|-3.78|-1.71|||ANCOVA|||Week 26||-1.71|-3.78|<0.001
72628129|NCT03235050|144784447|SUPERIORITY||LS Mean Difference|-3.55|||<|0.001|TWO_SIDED|95.0|-4.59|-2.52|||ANCOVA|||Week 26||-2.52|-4.59|<0.001
72628130|NCT03235050|144784447|SUPERIORITY||LS Mean Difference|-2.27||||0.003|TWO_SIDED|95.0|-3.74|-0.79|||ANCOVA|||Week 54||-0.79|-3.74|0.003
72542092|NCT05788237|144613913|OTHER||Geometric Mean Ratio|1.13|||||TWO_SIDED|95.0|0.867|1.473||||||GMR for HAI: H3N2 A/Darwin: RSVpreF + qIRV 1.0 mL (Group 1) to RSVpreF + qIRV 0.5 mL (Group 2)||1.473|0.867|
72542093|NCT05788237|144613913|OTHER||Geometric Mean Ratio|1.08|||||TWO_SIDED|95.0|0.849|1.383||||||GMR for HAI: B/Austria: RSVpreF + qIRV 1.0 mL (Group 1) to RSVpreF + qIRV 0.5 mL (Group 2)||1.383|0.849|
72576482|NCT02755649|144679524|SUPERIORITY||LS Mean Difference]|-28.5|||<|0.0001|TWO_SIDED|95.0|-37.34|-19.68||Threshold for significance at 0.05 level|ANCOVA|||Hierarchical testing approach was used to control Type-1 error rate at 0.05 across 2 dose regimens.CI with p-value based on treatment difference(dupilumab vs. placebo) of LS mean percent change using MI with ANCOVA model with baseline measurement as covariate \& treatment, randomization strata(disease severity\[IGA 3 vs IGA 4\] \& prior CSA use \[Yes,No\]) as fixed factors.Efficacy data from participants who received rescue treatment were set to missing after timepoint of rescue, then imputed by MI.||-19.68|-37.34|< 0.0001
72576483|NCT02755649|144679525|SUPERIORITY||LS Mean Difference|-28.7|||<|0.0001|TWO_SIDED|95.0|-35.56|-21.93||Threshold for significance at 0.05 level|ANCOVA|||Hierarchical testing approach was used to control Type-1 error rate at 0.05 across 2 dose regimens.CI with p-value based on treatment difference(dupilumab vs. placebo) of LS mean percent change using MI with ANCOVA model with baseline measurement as covariate \& treatment, randomization strata(disease severity\[IGA 3 vs IGA 4\] \& prior CSA use \[Yes,No\]) as fixed factors.Efficacy data from participants who received rescue treatment were set to missing after timepoint of rescue, then imputed by MI.||-21.93|-35.56|< 0.0001
72410186|NCT00456092|144328731|SUPERIORITY||Odds Ratio (OR)|1.568||||0.264|TWO_SIDED|95.0|0.79|3.11|||Chi-squared, Corrected|||||3.11|0.79|0.264
72410187|NCT00456092|144328731|SUPERIORITY||Odds Ratio (OR)|1.98||||0.071|TWO_SIDED|95.0|1.0|3.91|||Chi-squared, Corrected|||||3.91|1.00|0.071
72410188|NCT00456092|144328732|SUPERIORITY||Odds Ratio (OR)|1.305||||0.549|TWO_SIDED|95.0|0.66|2.57|||Chi-squared, Corrected|||||2.57|0.66|0.549
72410189|NCT00456092|144328732|SUPERIORITY||Odds Ratio (OR)|1.033||||1|TWO_SIDED|95.0|0.53|2.03|||Chi-squared, Corrected|||||2.03|0.53|1.000
72410190|NCT00456092|144328733|SUPERIORITY||Odds Ratio (OR)|2.06||||0.083|TWO_SIDED|95.0|0.98|4.34|||Chi-squared, Corrected|||||4.34|0.98|0.083
72410191|NCT00456092|144328733|SUPERIORITY||Odds Ratio (OR)|1.63||||0.279|TWO_SIDED|95.0|0.77|3.44|||Chi-squared, Corrected|||||3.44|0.77|0.279
72410192|NCT00456092|144328734|SUPERIORITY||Odds Ratio (OR)|1.32||||0.548|TWO_SIDED|95.0|0.66|2.66|||Chi-squared, Corrected|||||2.66|0.66|0.548
72410193|NCT00456092|144328734|SUPERIORITY||Odds Ratio (OR)|1.04||||1|TWO_SIDED|95.0|0.52|2.11|||Chi-squared, Corrected|||||2.11|0.52|1.000
72410194|NCT00456092|144328737|SUPERIORITY||Treatment Difference|11.58||||0.136|TWO_SIDED||||||ANOVA|ANOVA model with treatment as the factor.|Treatment Difference = Apremilast 20 mg BID - Placebo|||||0.136
72542094|NCT05788237|144613913|OTHER||Geometric Mean Ratio|1.1|||||TWO_SIDED|95.0|0.866|1.392||||||GMR for HAI: B/Phuket: RSVpreF + qIRV 1.0 mL (Group 1) to RSVpreF + qIRV 0.5 mL (Group 2)||1.392|0.866|
72542095|NCT01335399|144613947|SUPERIORITY|||||||0.4358|||||||Stratified Log Rank|||||||0.4358
72576484|NCT02755649|144679525|SUPERIORITY||LS Mean Difference|-32.9|||<|0.0001|TWO_SIDED|95.0|-39.7|-26.06||Threshold for significance at 0.05 level|ANCOVA|||Hierarchical testing approach was used to control Type-1 error rate at 0.05 across 2 dose regimens.CI with p-value based on treatment difference(dupilumab vs. placebo) of LS mean percent change using MI with ANCOVA model with baseline measurement as covariate \& treatment, randomization strata(disease severity\[IGA 3 vs IGA 4\] \& prior CSA use \[Yes,No\]) as fixed factors.Efficacy data from participants who received rescue treatment were set to missing after timepoint of rescue, then imputed by MI.||-26.06|-39.7|< 0.0001
72576485|NCT02755649|144679526|SUPERIORITY||difference in percentages|26.1|||<|0.0001|TWO_SIDED|95.0|13.89|38.39||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||A hierarchical testing approach was used to control Type-1 error at 0.05 across the 2 dose regimens. Difference is dupilumab minus placebo. CI calculated using normal approximation. P-values were derived by CMH test stratified by disease severity (IGA 3 vs IGA 4) and prior CSA use (Yes,No). Participants who used rescue treatment were categorized as non-responders from time rescue treatment was initiated. Participants with missing values at Week 16 were categorized as non-responders at Week 16.||38.39|13.89|< 0.0001
72542096|NCT01335399|144613947|SUPERIORITY||Hazard Ratio (HR)|0.93|||||TWO_SIDED|95.71|0.77|1.12|||||E-Ld/Ld. Calculated using Cox proportional hazards modeling|||1.12|0.77|
72542097|NCT01335399|144613948|SUPERIORITY||CMH ESTIMATE OF COMMON ODDS RATIO|1.26||||0.2232|TWO_SIDED|95.0|0.87|1.82|||CMH ESTIMATE OF COMMON ODDS RATIO|||||1.82|0.87|0.2232
72576486|NCT02755649|144679526|SUPERIORITY||difference in percentages|31.5|||<|0.0001|TWO_SIDED|95.0|19.08|43.83||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||A hierarchical testing approach was used to control Type-1 error at 0.05 across the 2 dose regimens. Difference is dupilumab minus placebo. CI calculated using normal approximation. P-values were derived by CMH test stratified by disease severity (IGA 3 vs IGA 4) and prior CSA use (Yes,No). Participants who used rescue treatment were categorized as non-responders from time rescue treatment was initiated. Participants with missing values at Week 16 were categorized as non-responders at Week 16.||43.83|19.08|< 0.0001
72542098|NCT01335399|144613949|SUPERIORITY||Hazard Ratio (HR)|0.99||||0.8932|TWO_SIDED|95.0|0.82|1.19|||Stratified log rank test||Stratified by stage of disease (International Staging System 1 - 2 vs 3), age (\<75 years old vs \>= 75 years old) and ECOG performance status (0 vs 1 - 2) at randomization.|||1.19|0.82|0.8932
72542099|NCT01335399|144613951|SUPERIORITY||Hazard Ratio (HR)|0.93||||0.4358|TWO_SIDED|95.0|0.78|1.12|||Hazard Ratio|||||1.12|0.78|0.4358
72542100|NCT02464059|144613954|SUPERIORITY||Mean Difference (Final Values)|-65.5|STANDARD_DEVIATION|207.8||0.21|TWO_SIDED|95.0|-172.4|41.3||P-value is not adjusted for multiple comparisons. A priori threshold for significance is p\<0.05.|t-test, 2 sided|||||41.3|-172.4|0.21
72542101|NCT02464059|144613955|SUPERIORITY||Mean Difference (Final Values)|-0.55|STANDARD_DEVIATION|12.6||0.86|TWO_SIDED|95.0|-7.02|5.91||P-value is not adjusted for multiple comparisons. A priori threshold for significance is p\<0.05.|t-test, 2 sided|||||5.91|-7.02|0.86
72542102|NCT03990389|144613965|SUPERIORITY|||||||0.0618||||||Three degrees of freedom for the interaction test|Mixed Models Analysis|||||||0.0618
72542103|NCT03990389|144613965|SUPERIORITY||estimated treatment effect at month 1|-2.29|STANDARD_ERROR_OF_MEAN|1.8||0.63|TWO_SIDED|||||Bonferroni correction for 3 times points|Mixed Models Analysis|||||||0.63
72542104|NCT03990389|144613965|SUPERIORITY||estimated treatment effect at month 2|-5.19|STANDARD_ERROR_OF_MEAN|1.9||0.018|TWO_SIDED|||||Bonferroni correction for 3 times points|Mixed Models Analysis|||||||0.018
72542105|NCT03990389|144613965|SUPERIORITY||estimated treatment effect at month 3|-3.3|STANDARD_ERROR_OF_MEAN|1.9||0.234|TWO_SIDED|||||Bonferroni correction for 3 times points|Mixed Models Analysis|||||||0.234
72542106|NCT03990389|144613966|OTHER|||||||0.116|||||||t-test, 2 sided|||||||0.116
72542107|NCT02290028|144613971|SUPERIORITY||||||<|0.0001|||||||Exact, binomial|||Primary endpoint 1 was evaluated by performing an exact, binomial test comparing the observed proportion (overall complication-free rate at 6 months) to the performance goal of 90.0%, with Type I error (alpha) of 0.025 and power of 80%. The lower, two-sided 95% confidence bound for the overall complication-free rate must be greater than 90.0%.||||<0.0001
72542108|NCT02290028|144613972|SUPERIORITY||||||=|0.002|||||||Exact, binomial|||Primary endpoint 2 was evaluated by performing an exact, binomial test comparing an observed proportion (rate of acceptable LV pacing thresholds at the permanently programmed pacing vector at 3 months) to 88%, with Type I error (alpha) of 0.025 and power of 80%. The lower, two-sided 95% confidence bound for the percentage of subjects with an acceptable LV pacing threshold in the permanently programmed pacing vector must be greater than 88.0%.||||=0.002
72542109|NCT02290028|144613973|SUPERIORITY|||||||||||||||||Primary endpoint 3 will be evaluated by performing an exact, binomial test comparing the observed proportion (overall complication-free rate at 5 years) to the performance goal of 92.5%, with Type I error (alpha) of 0.025 and power of 80%. The lower, two-sided 95% confidence bound for the overall complication-free rate must be greater than 92.5%|On September 24, 2019, BIOTRONIK received FDA approval to transition the ongoing Sentus Post Approval Registry to a new EP PASSION real-world data methodology. As of study closure, the number of subjects with complete data required to perform the hypothesis test was not met. Therefore, this outcome measure was not analyzed.|||
72542110|NCT03202511|144613982|EQUIVALENCE|0.8 to 1.25 equivalence margin was used.|Geometric Mean Ratio|1.61|||||TWO_SIDED|90.0|1.47|1.77||||||||1.77|1.47|
72542111|NCT03202511|144613983|EQUIVALENCE|80 to 125% equivalence margin was used.|Geometric Mean Ratio|77.4|||||TWO_SIDED|90.0|61.4|97.6||||||||97.6|61.4|
72542112|NCT00830063|144614029|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-1.24|STANDARD_ERROR_OF_MEAN|0.26|<|0.001|TWO_SIDED|95.0|-1.76|-0.72||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Least square (LS) mean was estimated from the corresponding analysis of covariance (ANCOVA) model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95 percent (%) confidence interval (CI) was calculated on LS mean difference.||-0.72|-1.76|<0.001
72410195|NCT00456092|144328737|SUPERIORITY||Treatment Difference|13.53||||0.08|TWO_SIDED||||||ANOVA|ANOVA model with treatment as the factor.|Treatment Difference = Apremilast 20 mg BID - Placebo|||||0.080
72542113|NCT00830063|144614029|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.0|STANDARD_ERROR_OF_MEAN|0.26|<|0.001|TWO_SIDED|95.0|-1.52|-0.49||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.49|-1.52|<0.001
72542114|NCT00830063|144614029|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.72|STANDARD_ERROR_OF_MEAN|0.26||0.007|TWO_SIDED|95.0|-1.23|-0.2||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.20|-1.23|0.007
72542115|NCT00830063|144614029|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.48|STANDARD_ERROR_OF_MEAN|0.26||0.068|TWO_SIDED|95.0|-0.99|0.03||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||0.03|-0.99|0.068
72542116|NCT00830063|144614030|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.25|STANDARD_ERROR_OF_MEAN|0.24|<|0.001|TWO_SIDED|95.0|-1.73|-0.77||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.77|-1.73|<0.001
72542117|NCT00830063|144614030|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.03|STANDARD_ERROR_OF_MEAN|0.24|<|0.001|TWO_SIDED|95.0|-1.51|-0.55||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.55|-1.51|<0.001
72542118|NCT00830063|144614030|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.76|STANDARD_ERROR_OF_MEAN|0.24||0.002|TWO_SIDED|95.0|-1.24|-0.28||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.28|-1.24|0.002
72542119|NCT00830063|144614030|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.53|STANDARD_ERROR_OF_MEAN|0.24||0.03|TWO_SIDED|95.0|-1.01|-0.05||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.05|-1.01|0.030
72542120|NCT00830063|144614031|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.33|STANDARD_ERROR_OF_MEAN|0.09|<|0.001|TWO_SIDED|95.0|-0.5|-0.16||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.16|-0.50|<0.001
72542121|NCT00830063|144614031|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.21|STANDARD_ERROR_OF_MEAN|0.09||0.014|TWO_SIDED|95.0|-0.39|-0.04||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.04|-0.39|0.014
72542122|NCT00830063|144614031|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.19|STANDARD_ERROR_OF_MEAN|0.09||0.026|TWO_SIDED|95.0|-0.36|-0.02||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.02|-0.36|0.026
72410196|NCT00456092|144328738|SUPERIORITY||Hazard Ratio (HR)|0.95||||0.65|TWO_SIDED|95.0|0.745|1.211|||Chi-squared||Based on a proportional hazards model comparing the hazard functions associated with the treatment and placebo.|||1.211|0.745|0.650
72410197|NCT00456092|144328738|SUPERIORITY||Hazard Ratio (HR)|1.265||||0.283|TWO_SIDED|95.0|0.791|2.024|||Chi-squared||Based on a proportional hazards model comparing the hazard functions associated with the treatment and placebo.|||2.024|0.791|0.283
72576487|NCT02755649|144679527|SUPERIORITY||LS Mean Difference|-17.95|||<|0.0001|TWO_SIDED|95.0|-22.706|-13.197||Threshold for significance at 0.05 level|ANCOVA|||Hierarchical testing approach was used to control Type-1 error rate at 0.05 across 2 dose regimens.CI with p-value is based on treatment difference(dupilumab vs. placebo) of LS mean percent change using MI with ANCOVA model with baseline measurement as covariate \& treatment,randomization strata(disease severity\[IGA 3 vs IGA 4\] \& prior CSA use \[Yes,No\]) as fixed factors. Efficacy data from participants who received rescue treatment were set to missing after timepoint of rescue, then imputed by MI||-13.197|-22.706|< 0.0001
72576488|NCT02755649|144679527|SUPERIORITY||LS Mean Difference|-19.66|||<|0.0001|TWO_SIDED|95.0|-24.431|-14.895||Threshold for significance at 0.05 level|ANCOVA|||Hierarchical testing approach was used to control Type-1 error rate at 0.05 across 2 dose regimens.CI with p-value based on treatment difference(dupilumab vs. placebo) of LS mean percent change using MI with ANCOVA model with baseline measurement as covariate \& treatment, randomization strata(disease severity\[IGA 3 vs IGA 4\] \& prior CSA use \[Yes,No\]) as fixed factors.Efficacy data from participants who received rescue treatment were set to missing after timepoint of rescue, then imputed by MI.||-14.895|-24.431|< 0.0001
72576489|NCT02755649|144679528|SUPERIORITY||Difference in Percentages|25.2|||<|0.0001|TWO_SIDED|95.0|13.99|36.41||Threshold for significance at 0.05 level|Cochran-Mantel-Haenszel|||A hierarchical testing approach was used to control Type-1 error at 0.05 across the 2 dose regimens. Difference is dupilumab minus placebo. CI calculated using normal approximation. P-values were derived by CMH test stratified by disease severity (IGA 3 vs IGA 4) and prior CSA use (Yes,No). Participants who used rescue treatment were categorized as non-responders from time rescue treatment was initiated. Participants with missing values at Week 16 were categorized as non-responders at Week 16.||36.41|13.99|< 0.0001
72576490|NCT02755649|144679528|SUPERIORITY||Difference in Percentages|26.3|||<|0.0001|TWO_SIDED|95.0|14.95|37.65||Threshold for significance at 0.05 level|Cochran-Mantel-Haenszel|||A hierarchical testing approach was used to control Type-1 error at 0.05 across the 2 dose regimens. Difference is dupilumab minus placebo. CI calculated using normal approximation. P-values were derived by CMH test stratified by disease severity (IGA 3 vs IGA 4) and prior CSA use (Yes,No). Participants who used rescue treatment were categorized as non-responders from time rescue treatment was initiated. Participants with missing values at Week 16 were categorized as non-responders at Week 16.||37.65|14.95|< 0.0001
72576491|NCT02755649|144679529|SUPERIORITY||LS Mean Difference|-4.3|||<|0.0001|TWO_SIDED|95.0|-5.6|-3.04||Threshold for significance at 0.05 level|ANCOVA|||Hierarchical testing approach was used to control Type-1 error rate at 0.05 across 2 dose regimens.CI with p-value based on treatment difference(dupilumab vs. placebo) of LS mean percent change using MI with ANCOVA model with baseline measurement as covariate \& treatment, randomization strata(disease severity\[IGA 3 vs IGA 4\] \& prior CSA use \[Yes,No\]) as fixed factors.Efficacy data from participants who received rescue treatment were set to missing after timepoint of rescue, then imputed by MI.||-3.04|-5.6|< 0.0001
72576492|NCT02755649|144679529|SUPERIORITY||LS Mean Difference|-5.0|||<|0.0001|TWO_SIDED|95.0|-6.31|-3.74||Threshold for significance at 0.05 level|ANCOVA|||Hierarchical testing approach was used to control Type-1 error rate at 0.05 across 2 dose regimens.CI with p-value based on treatment difference(dupilumab vs. placebo) of LS mean percent change using MI with ANCOVA model with baseline measurement as covariate \& treatment, randomization strata(disease severity\[IGA 3 vs IGA 4\] \& prior CSA use \[Yes,No\])as fixed factors. Efficacy data from participants who received rescue treatment were set to missing after timepoint of rescue, then imputed by MI.||-3.74|-6.31|< 0.0001
72576493|NCT02755649|144679530|SUPERIORITY||LS Mean Difference|-7.1|||<|0.0001|TWO_SIDED|95.0|-8.78|-5.47||Threshold for significance at 0.05 level|ANCOVA|||Hierarchical testing approach was used to control Type-1 error rate at 0.05 across 2 dose regimens.CI with p-value based on treatment difference(dupilumab vs. placebo) of LS mean percent change using MI with ANCOVA model with baseline measurement as covariate \& treatment, randomization strata(disease severity\[IGA 3 vs IGA 4\] \& prior CSA use \[Yes,No\])as fixed factors. Efficacy data from participants who received rescue treatment were set to missing after timepoint of rescue, then imputed by MI.||-5.47|-8.78|< 0.0001
72628131|NCT03235050|144784447|SUPERIORITY||LS Mean Difference|-2.16|||<|0.001|TWO_SIDED|95.0|-3.37|-0.95|||ANCOVA|||Week 54||-0.95|-3.37|<0.001
72628132|NCT03235050|144784447|SUPERIORITY||LS Mean Difference|-3.42|||<|0.001|TWO_SIDED|95.0|-4.63|-2.2|||ANCOVA|||Week 54||-2.20|-4.63|<0.001
72628133|NCT03235050|144784448|SUPERIORITY||LS Mean Difference|0.7||||0.211|TWO_SIDED|95.0|-0.39|1.79|||ANCOVA|||Percent change at Week 14||1.79|-0.39|0.211
72410198|NCT00456092|144328739|SUPERIORITY||Hazard Ratio (HR)|1.337||||0.253|TWO_SIDED|95.0|0.791|2.26|||Chi-squared||Based on a proportional hazards model comparing the hazard functions associated with the treatment and placebo.|||2.260|0.791|0.253
72410199|NCT00456092|144328739|SUPERIORITY||Hazard Ratio (HR)|3.023||||0.026|TWO_SIDED|95.0|1.059|8.63|||Chi-squared||Based on a proportional hazards model comparing the hazard functions associated with the treatment and placebo.|||8.630|1.059|0.026
72628134|NCT03235050|144784448|SUPERIORITY||LS Mean Difference|-0.07||||0.881|TWO_SIDED|95.0|-0.96|0.83|||ANCOVA|||Percent change at Week 14||0.83|-0.96|0.881
72628135|NCT03235050|144784448|SUPERIORITY||LS Mean Difference|-0.93||||0.042|TWO_SIDED|95.0|-1.82|-0.04|||ANCOVA|||Percent change at Week 14||-0.04|-1.82|0.042
72410200|NCT00456092|144328740|SUPERIORITY||Hazard Ratio (HR)|1.006||||0.984|TWO_SIDED|95.0|0.457|2.215|||Chi-squared||Based on a proportional hazards model comparing the hazard functions associated with the treatment and placebo.|||2.215|0.457|0.984
72628136|NCT03235050|144784448|SUPERIORITY||LS Mean Difference|0.9||||0.158|TWO_SIDED|95.0|-0.35|2.14|||ANCOVA|||Percent change at Week 26||2.14|-0.35|0.158
72628137|NCT03235050|144784448|SUPERIORITY||LS Mean Difference|0.18||||0.734|TWO_SIDED|95.0|-0.85|1.2|||ANCOVA|||Percent change at Week 26||1.20|-0.85|0.734
72628138|NCT03235050|144784448|SUPERIORITY||LS Mean Difference|-0.48||||0.357|TWO_SIDED|95.0|-1.51|0.54|||ANCOVA|||Percent change at Week 26||0.54|-1.51|0.357
72628139|NCT03235050|144784448|SUPERIORITY||LS Mean Difference|-0.07||||0.921|TWO_SIDED|95.0|-1.51|1.37|||ANCOVA|||Percent change at Week 54||1.37|-1.51|0.921
72542123|NCT00830063|144614031|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.08|STANDARD_ERROR_OF_MEAN|0.09||0.349|TWO_SIDED|95.0|-0.25|0.09||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||0.09|-0.25|0.349
72576494|NCT02755649|144679530|SUPERIORITY||LS Mean Difference|-7.6|||<|0.0001|TWO_SIDED|95.0|-9.29|-5.97||Threshold for significance at 0.05 level|ANCOVA|||Hierarchical testing approach was used to control Type-1 error rate at 0.05 across 2 dose regimens.CI with p-value based on treatment difference(dupilumab vs. placebo) of LS mean percent change using MI with ANCOVA model with baseline measurement as covariate \& treatment, randomization strata(disease severity\[IGA 3 vs IGA 4\] \& prior CSA use \[Yes,No\])as fixed factors. Efficacy data from participants who received rescue treatment were set to missing after timepoint of rescue, then imputed by MI.||-5.97|-9.29|< 0.0001
72576495|NCT02755649|144679531|SUPERIORITY||Difference in Percentages|30.1|||=|0.0002|TWO_SIDED|95.0|14.63|45.64||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||A hierarchical testing approach was used to control Type-1 error at 0.05 across the 2 dose regimens. Difference is dupilumab minus placebo. CI calculated using normal approximation. P-values were derived by CMH test stratified by disease severity (IGA 3 vs IGA 4) and prior CSA use (Yes,No). Participants who used rescue treatment were categorized as non-responders from time rescue treatment was initiated. Participants with missing values at Week 16 were categorized as non-responders at Week 16.||45.64|14.63|= 0.0002
72576496|NCT02755649|144679531|SUPERIORITY||Difference in Percentages|31.6|||=|0.0001|TWO_SIDED|95.0|16.11|47.05||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||Hierarchical testing approach was used to control Type-1 error at 0.05 across the 2 dose regimens. Difference is dupilumab minus placebo. CI calculated using normal approximation. P-values derived by CMH test stratified by disease severity (IGA 3 vs IGA 4) and prior CSA use (Yes,No). Participants who used rescue treatment were categorized as non-responders from time rescue treatment was initiated. Participants with missing values at Week 16 were categorized as non-responders at Week 16.||47.05|16.11|= 0.0001
72576497|NCT02755649|144679532|SUPERIORITY||LS Mean Difference|-7.6|||=|0.0003|TWO_SIDED|95.0|-11.64|-3.51||Threshold for significance at 0.05 level|ANCOVA|||Hierarchical testing approach was used to control Type-1 error rate at 0.05 across 2 dose regimens.CI with p-value based on treatment difference(dupilumab vs. placebo) of LS mean percent change using MI with ANCOVA model with baseline measurement as covariate \& treatment, randomization strata(disease severity\[IGA 3 vs IGA 4\] \& prior CSA use \[Yes,No\]) as fixed factors.Efficacy data from participants who received rescue treatment were set to missing after timepoint of rescue, then imputed by MI.||-3.51|-11.64|= 0.0003
72576498|NCT02755649|144679532|SUPERIORITY||LS Mean Difference|-10.1|||<|0.0001|TWO_SIDED|95.0|-14.15|-5.95||Threshold for significance at 0.05 level|ANCOVA|||Hierarchical testing approach was used to control Type-1 error rate at 0.05 across 2 dose regimens.CI with p-value based on treatment difference(dupilumab vs. placebo) of LS mean percent change using MI with ANCOVA model with baseline measurement as covariate \& treatment, randomization strata(disease severity\[IGA 3 vs IGA 4\] \& prior CSA use \[Yes,No\]) as fixed factors.Efficacy data from participants who received rescue treatment were set to missing after timepoint of rescue, then imputed by MI.||-5.95|-14.15|< 0.0001
72576499|NCT02755649|144679533|SUPERIORITY||LS Mean Difference|-2.9|||=|0.0001|TWO_SIDED|95.0|-4.41|-1.43||Threshold for significance at 0.05 level|ANCOVA|||Hierarchical testing approach was used to control Type-1 error rate at 0.05 across 2 dose regimens.CI with p-value based on treatment difference(dupilumab vs. placebo) of LS mean percent change using MI with ANCOVA model with baseline measurement as covariate \& treatment, randomization strata(disease severity\[IGA 3 vs IGA 4\] \& prior CSA use \[Yes,No\]) as fixed factors.Efficacy data from participants who received rescue treatment were set to missing after timepoint of rescue, then imputed by MI.||-1.43|-4.41|= 0.0001
72576500|NCT02755649|144679533|SUPERIORITY||LS Mean Difference|-3.9|||<|0.0001|TWO_SIDED|95.0|-5.38|-2.4||Threshold for significance at 0.05 level|ANCOVA|||Hierarchical testing approach was used to control Type-1 error rate at 0.05 across 2 dose regimens.CI with p-value based on treatment difference(dupilumab vs. placebo) of LS mean percent change using MI with ANCOVA model with baseline measurement as covariate \& treatment, randomization strata(disease severity\[IGA 3 vs IGA 4\] \& prior CSA use \[Yes,No\]) as fixed factors.Efficacy data from participants who received rescue treatment were set to missing after timepoint of rescue, then imputed by MI.||-2.4|-5.38|< 0.0001
72576501|NCT02755649|144679534|SUPERIORITY||Difference in Percentages|29.5|||<|0.0001|TWO_SIDED|95.0|17.1|41.96||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||A hierarchical testing approach was used to control Type-1 error at 0.05 across the 2 dose regimens. Difference is dupilumab minus placebo. CI calculated using normal approximation. P-values were derived by CMH test stratified by disease severity (IGA 3 vs IGA 4) and prior CSA use (Yes,No). Participants who used rescue treatment were categorized as non-responders from time rescue treatment was initiated. Participants with missing values at Week 16 were categorized as non-responders at Week 16.||41.96|17.1|< 0.0001
72576502|NCT02755649|144679534|SUPERIORITY||Difference in Percentages|40.4|||<|0.0001|TWO_SIDED|95.0|28.24|52.61||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||A hierarchical testing approach was used to control Type-1 error at 0.05 across the 2 dose regimens. Difference is dupilumab minus placebo. CI calculated using normal approximation. P-values were derived by CMH test stratified by disease severity (IGA 3 vs IGA 4) and prior CSA use (Yes,No). Participants who used rescue treatment were categorized as non-responders from time rescue treatment was initiated. Participants with missing values at Week 16 were categorized as non-responders at Week 16.||52.61|28.24|< 0.0001
72369109|NCT00478023|144248219|SUPERIORITY_OR_OTHER_LEGACY||Least square mean difference|23.3|||<|0.0001||95.0|16.3|30.4||Adjusted. The Hochberg procedure used for multiplicity comparisons.|ANCOVA|ANCOVA with treatment and centre as fixed effects and baseline pain as covariate.|Only pain intensity assessments collected prior to the first dose of any additional analgesic medication considered. Afterwards LOCF used.|The null hypothesis is that all CG5503 IR dose groups are equal to the placebo group based on the mean sum of pain intensity difference at 24 hours (SPID24). The alternative hypothesis is that at least one CG5503 IR dose group is different from the placebo group based on the mean SPID24.||30.4|16.3|<0.0001
72410201|NCT00456092|144328740|SUPERIORITY||Hazard Ratio (HR)|0.872||||0.836|TWO_SIDED|95.0|0.158|4.797|||Chi-squared||Based on a proportional hazards model comparing the hazard functions associated with the treatment and placebo.|||4.797|0.158|0.836
72542124|NCT00830063|144614032|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.22|STANDARD_ERROR_OF_MEAN|0.24||0.355|TWO_SIDED|95.0|-0.69|0.25||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 2: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||0.25|-0.69|0.355
72542125|NCT00830063|144614032|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.57|STANDARD_ERROR_OF_MEAN|0.24||0.017|TWO_SIDED|95.0|-1.04|-0.1||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 2: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.10|-1.04|0.017
72576503|NCT02755649|144679535|SUPERIORITY||LS Mean Difference|-24.3|||<|0.0001|TWO_SIDED|95.0|-31.63|-16.88||Threshold for significance at 0.05 level.|ANCOVA|||A hierarchical testing approach was used to control Type-1 error rate at 0.05 across 2 dose regimens.CI with p-value based on treatment difference(dupilumab group vs. placebo)of LS mean percent change using MI with ANCOVA with baseline measurement as covariate \& treatment,randomization strata(disease severity\[IGA 3 vs IGA 4\] \& prior CSA use\[Yes,No\])as fixed factors.Efficacy data from participants who received rescue treatment were set to missing after timepoint of rescue, then imputed by MI.||-16.88|-31.63|< 0.0001
72576504|NCT02755649|144679535|SUPERIORITY||LS Mean Difference|-26.2|||<|0.0001|TWO_SIDED|95.0|-33.49|-18.86||Threshold for significance at 0.05 level.|ANCOVA|||Hierarchical testing approach was used to control Type-1 error rate at 0.05 across 2 dose regimens.CI with p-value based on treatment difference(dupilumab vs. placebo) of LS mean percent change using MI with ANCOVA model with baseline measurement as covariate \& treatment, randomization strata (disease severity\[IGA 3 vs IGA 4\] \& prior CSA use \[Yes,No\]) as fixed factors.Efficacy data from participants who received rescue treatment were set to missing after timepoint of rescue, then imputed by MI.||-18.86|-33.49|< 0.0001
72628140|NCT03235050|144784448|SUPERIORITY||LS Mean Difference|0.12||||0.847|TWO_SIDED|95.0|-1.07|1.3|||ANCOVA|||Percent change at Week 54||1.30|-1.07|0.847
72628141|NCT03235050|144784448|SUPERIORITY||LS Mean Difference|-0.96||||0.112|TWO_SIDED|95.0|-2.15|0.22|||ANCOVA|||Percent change at Week 54||0.22|-2.15|0.112
72628142|NCT03235050|144784449|SUPERIORITY||LS Mean Difference|0.59||||0.284|TWO_SIDED|95.0|-0.49|1.68|||ANCOVA|||Absolute change at Week 14||1.68|-0.49|0.284
72410202|NCT00456092|144328745|SUPERIORITY||Adjusted Mean Difference|1.4||||0.308|TWO_SIDED||||||ANOVA|ANOVA model including treatment group, methotrexate use, and baseline score.|Adjusted mean difference (Apremilast-Placebo) was based on the ANOVA model described above.|Mental Component||||0.308
72410203|NCT00456092|144328745|SUPERIORITY||Adjusted Mean Difference|4.1||||0.003|TWO_SIDED||||||ANOVA|ANOVA model including treatment group, methotrexate use, and baseline score.|Adjusted mean difference (Apremilast-Placebo) was based on the ANOVA model described above.|Mental Component||||0.003
72542126|NCT00830063|144614032|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.56|STANDARD_ERROR_OF_MEAN|0.24||0.02|TWO_SIDED|95.0|0.09|1.03||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 2: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||1.03|0.09|0.020
72542127|NCT00830063|144614032|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.21|STANDARD_ERROR_OF_MEAN|0.24||0.388|TWO_SIDED|95.0|-0.26|0.67||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 2: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||0.67|-0.26|0.388
72542128|NCT00830063|144614032|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.18|STANDARD_ERROR_OF_MEAN|0.24|<|0.001|TWO_SIDED|95.0|-1.65|-0.7||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 4: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.70|-1.65|<0.001
72542129|NCT00830063|144614032|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.6|STANDARD_ERROR_OF_MEAN|0.24|<|0.001|TWO_SIDED|95.0|-2.07|-1.13||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 4: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-1.13|-2.07|<0.001
72542130|NCT00830063|144614032|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.26|STANDARD_ERROR_OF_MEAN|0.24||0.274|TWO_SIDED|95.0|-0.73|0.21||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 4: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||0.21|-0.73|0.274
72542131|NCT00830063|144614032|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.69|STANDARD_ERROR_OF_MEAN|0.24||0.004|TWO_SIDED|95.0|-1.16|-0.22||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 4: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.22|-1.16|0.004
72628143|NCT03235050|144784449|SUPERIORITY||LS Mean Difference|-0.2||||0.658|TWO_SIDED|95.0|-1.09|0.69|||ANCOVA|||Absolute change at Week 14||0.69|-1.09|0.658
72628144|NCT03235050|144784449|SUPERIORITY||LS Mean Difference|-1.17||||0.01|TWO_SIDED|95.0|-2.06|-0.27|||ANCOVA|||Absolute change at Week 14||-0.27|-2.06|0.010
72628145|NCT03235050|144784449|SUPERIORITY||LS Mean Difference|0.7||||0.279|TWO_SIDED|95.0|-0.57|1.97|||ANCOVA|||Absolute change at Week 26||1.97|-0.57|0.279
72628146|NCT03235050|144784449|SUPERIORITY||LS Mean Difference|-0.04||||0.94|TWO_SIDED|95.0|-1.08|1.0|||ANCOVA|||Absolute change at Week 26||1.00|-1.08|0.940
72628147|NCT03235050|144784449|SUPERIORITY||LS Mean Difference|-0.85||||0.11|TWO_SIDED|95.0|-1.89|0.19|||ANCOVA|||Absolute change at Week 26||0.19|-1.89|0.110
72628148|NCT03235050|144784449|SUPERIORITY||LS Mean Difference|-0.26||||0.73|TWO_SIDED|95.0|-1.74|1.22|||ANCOVA|||Absolute change at Week 54||1.22|-1.74|0.730
72628149|NCT03235050|144784449|SUPERIORITY||LS Mean Difference|-0.15||||0.804|TWO_SIDED|95.0|-1.38|1.07|||ANCOVA|||Absolute change at Week 54||1.07|-1.38|0.804
72628150|NCT03235050|144784449|SUPERIORITY||LS Mean Difference|-1.41||||0.023|TWO_SIDED|95.0|-2.63|-0.19|||ANCOVA|||Absolute change at Week 54||-0.19|-2.63|0.023
72628151|NCT03235050|144784450|SUPERIORITY||Odds Ratio, log|8.37|||<|0.001|TWO_SIDED|95.0|2.38|29.43|||Regression, Logistic|||weight loss \>=5% at Week 14||29.43|2.38|<0.001
72542132|NCT00830063|144614032|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.25|STANDARD_ERROR_OF_MEAN|0.25|<|0.001|TWO_SIDED|95.0|-1.74|-0.75||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 8: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.75|-1.74|<0.001
72542133|NCT00830063|144614032|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.5|STANDARD_ERROR_OF_MEAN|0.25|<|0.001|TWO_SIDED|95.0|-2.0|-1.01||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 8: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-1.01|-2.00|<0.001
72628152|NCT03235050|144784450|SUPERIORITY||Odds Ratio, log|12.46|||<|0.001|TWO_SIDED|95.0|3.82|40.64|||Regression, Logistic|||weight loss \>=5% at Week 14||40.64|3.82|<0.001
72542134|NCT00830063|144614032|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.49|STANDARD_ERROR_OF_MEAN|0.25||0.051|TWO_SIDED|95.0|-0.99|0.0||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 8: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||0.00|-0.99|0.051
72542135|NCT00830063|144614032|SUPERIORITY_OR_OTHER_LEGACY||Slope|-0.75|STANDARD_ERROR_OF_MEAN|0.25||0.003|TWO_SIDED|95.0|-1.24|-0.25||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 8: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.25|-1.24|0.003
72542136|NCT00830063|144614032|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.59|STANDARD_ERROR_OF_MEAN|0.27|<|0.001|TWO_SIDED|95.0|-2.12|-1.07||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 12: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference||-1.07|-2.12|<0.001
72542137|NCT00830063|144614032|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.37|STANDARD_ERROR_OF_MEAN|0.27|<|0.001|TWO_SIDED|95.0|-1.9|-0.85||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 12: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference||-0.85|-1.90|<0.001
72542138|NCT00830063|144614032|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.89|STANDARD_ERROR_OF_MEAN|0.27|<|0.001|TWO_SIDED|95.0|-1.42|-0.37||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 12: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.37|-1.42|<0.001
72542139|NCT00830063|144614032|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.67|STANDARD_ERROR_OF_MEAN|0.27||0.012|TWO_SIDED|95.0|-1.19|-0.15||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 12: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.15|-1.19|0.012
72542140|NCT00830063|144614033|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.22|STANDARD_ERROR_OF_MEAN|0.24||0.355|TWO_SIDED|95.0|-0.69|0.25||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 2: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||0.25|-0.69|0.355
72542141|NCT00830063|144614033|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.57|STANDARD_ERROR_OF_MEAN|0.24||0.017|TWO_SIDED|95.0|-1.04|-0.1||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 2: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.10|-1.04|0.017
72542142|NCT00830063|144614033|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.56|STANDARD_ERROR_OF_MEAN|0.24||0.02|TWO_SIDED|95.0|0.09|1.03||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 2: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||1.03|0.09|0.020
72542143|NCT00830063|144614033|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.21|STANDARD_ERROR_OF_MEAN|0.24||0.388|TWO_SIDED|95.0|-0.26|0.67||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 2: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||0.67|-0.26|0.388
72542144|NCT00830063|144614033|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.98|STANDARD_ERROR_OF_MEAN|0.24|<|0.001|TWO_SIDED|95.0|-1.45|-0.52||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 4: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.52|-1.45|<0.001
72542145|NCT00830063|144614033|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.56|STANDARD_ERROR_OF_MEAN|0.24|<|0.001|TWO_SIDED|95.0|-2.02|-1.1||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 4: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-1.10|-2.02|<0.001
72542146|NCT00830063|144614033|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.22|STANDARD_ERROR_OF_MEAN|0.24||0.361|TWO_SIDED|95.0|-0.68|0.25||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 4: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||0.25|-0.68|0.361
72628153|NCT03235050|144784450|SUPERIORITY||Odds Ratio, log|21.26|||<|0.001|TWO_SIDED|95.0|6.55|68.97|||Regression, Logistic|||weight loss \>=5% at Week 14||68.97|6.55|<0.001
72628154|NCT03235050|144784450|SUPERIORITY||Odds Ratio, log|3.68|||<|0.001|TWO_SIDED|95.0|1.72|7.89|||Regression, Logistic|||weight loss \>=5% at Week 26||7.89|1.72|<0.001
72628155|NCT03235050|144784450|SUPERIORITY||Odds Ratio, log|3.95|||<|0.001|TWO_SIDED|95.0|2.0|7.78|||Regression, Logistic|||weight loss \>=5% at Week 26||7.78|2.00|<0.001
72628156|NCT03235050|144784450|SUPERIORITY||Odds Ratio, log|7.28|||<|0.001|TWO_SIDED|95.0|3.72|14.24|||Regression, Logistic|||weight loss \>=5% at Week 26||14.24|3.72|<0.001
72410204|NCT00456092|144328745|SUPERIORITY||Adjusted Mean Difference|1.6||||0.182|TWO_SIDED||||||ANOVA|ANOVA model including treatment group, methotrexate use, and baseline score.|Adjusted mean difference (Apremilast-Placebo) was based on the ANOVA model described above.|Physical Component||||0.182
72542147|NCT00830063|144614033|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.79|STANDARD_ERROR_OF_MEAN|0.23|<|0.001|TWO_SIDED|95.0|-1.25|-0.33||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 4: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.33|-1.25|<0.001
72576505|NCT02755649|144679536|SUPERIORITY||LS Mean Difference|-9.7|||=|0.0017|TWO_SIDED|95.0|-15.8|-3.66||Threshold for significance at 0.05 level|ANCOVA|||Hierarchical testing approach was used to control Type-1 error rate at 0.05 across 2 dose regimens. CI with p-value based on treatment difference(dupilumab vs. placebo) of LS mean percent change using MI with ANCOVA model with baseline measurement as covariate \& treatment, randomization strata(disease severity\[IGA 3 vs IGA 4\] \& prior CSA use \[Yes,No\]) as fixed factors.Efficacy data from participants who received rescue treatment were set to missing after timepoint of rescue, then imputed by MI.||-3.66|-15.8|= 0.0017
72576506|NCT02755649|144679536|SUPERIORITY||LS Mean Difference|-7.2|||=|0.0214|TWO_SIDED|95.0|-13.31|-1.06||Threshold for significance at 0.05 level|ANCOVA|||Hierarchical testing approach was used to control Type-1 error rate at 0.05 across 2 dose regimens.CI with p-value based on treatment difference(dupilumab vs. placebo) of LS mean percent change using MI with ANCOVA model with baseline measurement as covariate \& treatment, randomization strata(disease severity\[IGA 3 vs IGA 4\] \& prior CSA use \[Yes,No\]) as fixed factors.Efficacy data from participants who received rescue treatment were set to missing after timepoint of rescue, then imputed by MI.||-1.06|-13.31|= 0.0214
72576507|NCT02755649|144679537|SUPERIORITY||Difference in Percentages|-4.7|||=|0.1486|TWO_SIDED|95.0|-10.97|1.58|||Cochran-Mantel-Haenszel|||A hierarchical testing approach was used to control Type-1 error at 0.05 across the 2 dose regimens. Difference is dupilumab minus placebo. CI calculated using normal approximation. P-values were derived by CMH test stratified by disease severity (IGA 3 vs IGA 4) and prior CSA use (Yes,No). Participants who used rescue treatment were categorized as non-responders from time rescue treatment was initiated. Participants with missing values at Week 16 were categorized as non-responders at Week 16.||1.58|-10.97|= 0.1486
72576508|NCT02755649|144679537|SUPERIORITY||Difference in Percentages|-6.5|||=|0.0319|TWO_SIDED|95.0|-12.27|-0.65|||Cochran-Mantel-Haenszel|||A hierarchical testing approach was used to control Type-1 error at 0.05 across the 2 dose regimens. Difference is dupilumab minus placebo. CI calculated using normal approximation. P-values were derived by CMH test stratified by disease severity (IGA 3 vs IGA 4) and prior CSA use (Yes,No). Participants who used rescue treatment were categorized as non-responders from time rescue treatment was initiated. Participants with missing values at Week 16 were categorized as non-responders at Week 16.||-0.65|-12.27|= 0.0319
72576509|NCT02755649|144679538|SUPERIORITY||difference in percentages|0.0|||=|0.9829|TWO_SIDED|95.0|-3.6|3.53|||Cochran-Mantel-Haenszel|||A hierarchical testing approach was used to control Type-1 error at 0.05 across the 2 dose regimens. Difference is dupilumab minus placebo. CI calculated using normal approximation. P-values were derived by CMH test stratified by disease severity (IGA 3 vs IGA 4) and prior CSA use (Yes,No). Participants who used rescue treatment were categorized as non-responders from time rescue treatment was initiated. Participants with missing values at Week 16 were categorized as non-responders at Week 16.||3.53|-3.6|= 0.9829
72576510|NCT02755649|144679538|SUPERIORITY||difference in percentages|0.0|||=|1|TWO_SIDED|95.0|-3.6|3.63|||Cochran-Mantel-Haenszel|||A hierarchical testing approach was used to control Type-1 error at 0.05 across the 2 dose regimens. Difference is dupilumab minus placebo. CI calculated using normal approximation. P-values were derived by CMH test stratified by disease severity (IGA 3 vs IGA 4) and prior CSA use (Yes,No). Participants who used rescue treatment were categorized as non-responders from time rescue treatment was initiated. Participants with missing values at Week 16 were categorized as non-responders at Week 16.||3.63|-3.6|= 1
72576511|NCT02755649|144679539|SUPERIORITY||difference in percentages|0.9|||=|0.5619|TWO_SIDED|95.0|-2.19|3.97|||Cochran-Mantel-Haenszel|||A hierarchical testing approach was used to control Type-1 error at 0.05 across the 2 dose regimens. Difference is dupilumab minus placebo. CI calculated using normal approximation. P-values were derived by CMH test stratified by disease severity (IGA 3 vs IGA 4) and prior CSA use (Yes,No). Participants who used rescue treatment were categorized as non-responders from time rescue treatment was initiated. Participants with missing values at Week 16 were categorized as non-responders at Week 16.||3.97|-2.19|= 0.5619
72576512|NCT02755649|144679539|SUPERIORITY||difference in percentages|-0.9|||=|0.3241|TWO_SIDED|95.0|-2.73|0.88|||Cochran-Mantel-Haenszel|||A hierarchical testing approach was used to control Type-1 error at 0.05 across the 2 dose regimens. Difference is dupilumab minus placebo. CI calculated using normal approximation. P-values were derived by CMH test stratified by disease severity (IGA 3 vs IGA 4) and prior CSA use (Yes,No). Participants who used rescue treatment were categorized as non-responders from time rescue treatment was initiated. Participants with missing values at Week 16 were categorized as non-responders at Week 16.||0.88|-2.73|= 0.3241
72628157|NCT03235050|144784450|SUPERIORITY||Odds Ratio, log|3.71|||<|0.001|TWO_SIDED|95.0|1.84|7.45|||Regression, Logistic|||weight loss \>=5% at Week 54||7.45|1.84|<0.001
72410205|NCT00456092|144328745|SUPERIORITY||Adjusted Mean Difference|2.7||||0.026|TWO_SIDED||||||ANOVA|ANOVA model including treatment group, methotrexate use, and baseline score.|Adjusted mean difference (Apremilast-Placebo) was based on the ANOVA model described above.|Physical Component||||0.026
72542148|NCT00830063|144614033|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.06|STANDARD_ERROR_OF_MEAN|0.24|<|0.001|TWO_SIDED|95.0|-1.54|-0.59||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 8: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.59|-1.54|<0.001
72628158|NCT03235050|144784450|SUPERIORITY||Odds Ratio, log|2.73||||0.002|TWO_SIDED|95.0|1.46|5.09|||Regression, Logistic|||weight loss \>=5% at Week 54||5.09|1.46|0.002
72628159|NCT03235050|144784450|SUPERIORITY||Odds Ratio, log|4.48|||<|0.001|TWO_SIDED|95.0|2.42|8.3|||ANCOVA|||weight loss \>=5% at Week 54||8.30|2.42|<0.001
72628160|NCT03235050|144784450|SUPERIORITY||Odds Ratio, log|8.47||||0.048|TWO_SIDED|95.0|1.02|70.17|||Regression, Logistic|||weight loss \>=10% at Week 26||70.17|1.02|0.048
72410206|NCT00456092|144328746|SUPERIORITY||Adjusted Mean Difference|-2.1||||0.016|TWO_SIDED||||||ANOVA|ANOVA model using treatment group, methotrexate use, and interaction of treatment group and methotrexate use as factors.|The adjusted mean difference (Apremilast-Placebo) is based on an ANOVA model described above.|||||0.016
72410207|NCT00456092|144328746|SUPERIORITY||Adjusted Mean Difference|-1.4||||0.105|TWO_SIDED||||||ANOVA|ANOVA model using treatment group, methotrexate use, and interaction of treatment group and methotrexate use as factors.|The adjusted mean difference (Apremilast-Placebo) is based on an ANOVA model described above.|||||0.105
72542149|NCT00830063|144614033|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.57|STANDARD_ERROR_OF_MEAN|0.24|<|0.001|TWO_SIDED|95.0|-2.04|-1.09||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 8: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-1.09|-2.04|<0.001
72542150|NCT00830063|144614033|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.45|STANDARD_ERROR_OF_MEAN|0.24||0.063|TWO_SIDED|95.0|-0.93|0.02||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 8: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||0.02|-0.93|0.063
72542151|NCT00830063|144614033|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.96|STANDARD_ERROR_OF_MEAN|0.24|<|0.001|TWO_SIDED|95.0|-1.43|-0.48||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 8: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.48|-1.43|<0.001
72542152|NCT00830063|144614033|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.2|STANDARD_ERROR_OF_MEAN|0.25|<|0.001|TWO_SIDED|95.0|-1.7|-0.71||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 12: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.71|-1.70|<0.001
72542153|NCT00830063|144614033|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.35|STANDARD_ERROR_OF_MEAN|0.25|<|0.001|TWO_SIDED|95.0|-1.85|-0.86||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 12: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.86|-1.85|<0.001
72542154|NCT00830063|144614033|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.7|STANDARD_ERROR_OF_MEAN|0.25||0.006|TWO_SIDED|95.0|-1.19|-0.21||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 12: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.21|-1.19|0.006
72542155|NCT00830063|144614033|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.85|STANDARD_ERROR_OF_MEAN|0.25|<|0.001|TWO_SIDED|95.0|-1.34|-0.36||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 12: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.36|-1.34|<0.001
72542156|NCT00830063|144614034|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.22|STANDARD_ERROR_OF_MEAN|0.24||0.355|TWO_SIDED|95.0|-0.69|0.25||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 2: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||0.25|-0.69|0.355
72542157|NCT00830063|144614034|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.57|STANDARD_ERROR_OF_MEAN|0.24||0.017|TWO_SIDED|95.0|-1.04|-0.1||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 2: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.10|-1.04|0.017
72628161|NCT03235050|144784450|SUPERIORITY||Odds Ratio, log|13.81||||0.01|TWO_SIDED|95.0|1.85|102.91|||Regression, Logistic|||weight loss \>=10% at Week 26||102.91|1.85|0.010
72628162|NCT03235050|144784450|SUPERIORITY||Odds Ratio, log|13.09||||0.012|TWO_SIDED|95.0|1.75|97.68|||Regression, Logistic|||weight loss \>=10% at Week 26||97.68|1.75|0.012
72628163|NCT03235050|144784450|SUPERIORITY||Odds Ratio, log|6.92||||0.013|TWO_SIDED|95.0|1.49|32.07|||Regression, Logistic|||weight loss \>=10% at Week 54||32.07|1.49|0.013
72628164|NCT03235050|144784450|SUPERIORITY||Odds Ratio, log|4.98||||0.032|TWO_SIDED|95.0|1.15|21.6|||Regression, Logistic|||weight loss \>=10% at Week 54||21.60|1.15|0.032
72628165|NCT03235050|144784450|SUPERIORITY||Odds Ratio, log|7.91||||0.005|TWO_SIDED|95.0|1.86|33.64|||Regression, Logistic|||weight loss \>=10% at Week 54||33.64|1.86|0.005
72542158|NCT00830063|144614034|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.56|STANDARD_ERROR_OF_MEAN|0.24||0.02|TWO_SIDED|95.0|0.09|1.03||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 2: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||1.03|0.09|0.020
72542159|NCT00830063|144614034|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.21|STANDARD_ERROR_OF_MEAN|0.24||0.388|TWO_SIDED|95.0|-0.26|0.67||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 2: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||0.67|-0.26|0.388
72542160|NCT00830063|144614034|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.18|STANDARD_ERROR_OF_MEAN|0.24|<|0.001|TWO_SIDED|95.0|-1.65|-0.7||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 4: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.70|-1.65|<0.001
72542161|NCT00830063|144614034|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.6|STANDARD_ERROR_OF_MEAN|0.24|<|0.001|TWO_SIDED|95.0|-2.07|-1.13||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 4: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference||-1.13|-2.07|<0.001
72628166|NCT03235050|144784451|SUPERIORITY||Odds Ratio, log|0.09||||0.024|TWO_SIDED|95.0|0.01|0.73|||Regression, Logistic|||received rescue medication at 14 wks||0.73|0.01|0.024
72576513|NCT02755649|144679540|SUPERIORITY||difference in percentages|-0.4|||=|0.9518|TWO_SIDED|95.0|-12.6|11.9|||Cochran-Mantel-Haenszel|||A hierarchical testing approach was used to control Type-1 error at 0.05 across the 2 dose regimens. Difference is dupilumab minus placebo. CI calculated using normal approximation. P-values were derived by CMH test stratified by disease severity (IGA 3 vs IGA 4) and prior CSA use (Yes,No). Participants who used rescue treatment were categorized as non-responders from time rescue treatment was initiated. Participants with missing values at Week 16 were categorized as non-responders at Week 16.||11.9|-12.6|= 0.9518
72576514|NCT02755649|144679540|SUPERIORITY||difference in percentages|2.5|||=|0.6833|TWO_SIDED|95.0|-9.64|14.68|||Cochran-Mantel-Haenszel|||A hierarchical testing approach was used to control Type-1 error at 0.05 across the 2 dose regimens. Difference is dupilumab minus placebo. CI calculated using normal approximation. P-values were derived by CMH test stratified by disease severity (IGA 3 vs IGA 4) and prior CSA use (Yes,No). Participants who used rescue treatment were categorized as non-responders from time rescue treatment was initiated. Participants with missing values at Week 16 were categorized as non-responders at Week 16.||14.68|-9.64|= 0.6833
72576515|NCT02152605|144679541|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-4.03|||<|0.001|TWO_SIDED|95.0|-6.28|-1.79|||Mixed Models Analysis|||||-1.79|-6.28|<0.001
72576516|NCT02152605|144679542|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.122|||<|0.001|TWO_SIDED|95.0|0.071|0.172|||Mixed Models Analysis|||||0.172|0.071|<0.001
72628167|NCT03235050|144784451|SUPERIORITY||Odds Ratio, log|0.11|||<|0.001|TWO_SIDED|95.0|0.03|0.4|||Regression, Logistic|||received rescue medication at 14 wks||0.40|0.03|<0.001
72628168|NCT03235050|144784451|SUPERIORITY||Odds Ratio, log|0.07|||<|0.001|TWO_SIDED|95.0|0.02|0.33|||Regression, Logistic|||received rescue medication at 14 wks||0.33|0.02|<0.001
72628169|NCT03235050|144784451|SUPERIORITY||Odds Ratio, log|0.14||||0.002|TWO_SIDED|95.0|0.04|0.48|||Regression, Logistic|||received rescue medication at 26 wks||0.48|0.04|0.002
72628170|NCT03235050|144784451|SUPERIORITY||Odds Ratio, log|0.14|||<|0.001|TWO_SIDED|95.0|0.06|0.34|||Regression, Logistic|||received rescue medication at 26 wks||0.34|0.06|<0.001
72628171|NCT03235050|144784451|SUPERIORITY||Odds Ratio, log|0.11|||<|0.001|TWO_SIDED|95.0|0.04|0.28|||Regression, Logistic|||received rescue medication at 26 wks||0.28|0.04|<0.001
72628172|NCT03235050|144784451|SUPERIORITY||Odds Ratio, log|0.24|||<|0.001|TWO_SIDED|95.0|0.11|0.53|||Regression, Logistic|||received rescue medication at 54 wks||0.53|0.11|<0.001
72628173|NCT03235050|144784451|SUPERIORITY||Odds Ratio, log|0.24|||<|0.001|TWO_SIDED|95.0|0.13|0.44|||Regression, Logistic|||received rescue medication at 54 wks||0.44|0.13|<0.001
72410208|NCT00456092|144328748|SUPERIORITY||Adjusted Mean Difference|3.3||||0.028|TWO_SIDED||||||ANOVA|ANOVA model with treatment, methotrexate use, and interaction of treatment group and methotrexate use as factors and baseline score as the covariate.|The adjusted mean difference (Apremilast-Placebo) is based on an ANOVA model described above.|||||0.028
72628174|NCT03235050|144784451|SUPERIORITY||Odds Ratio, log|0.22|||<|0.001|TWO_SIDED|95.0|0.12|0.41|||Regression, Logistic|||received rescue medication at 54 wks||0.41|0.12|<0.001
72628175|NCT03235050|144784451|SUPERIORITY||Odds Ratio, log|0.22||||0.216|TWO_SIDED|95.0|0.02|2.43|||Regression, Logistic|||discontinued IP at 14 wks||2.43|0.02|0.216
72628176|NCT03235050|144784451|SUPERIORITY||Odds Ratio, log|0.28||||0.253|TWO_SIDED|95.0|0.03|2.52|||Regression, Logistic|||discontinued IP at 26 wks||2.52|0.03|0.253
72628177|NCT03235050|144784451|SUPERIORITY||Odds Ratio, log|0.21||||0.079|TWO_SIDED|95.0|0.04|1.19|||Regression, Logistic|||discontinued IP at 26 wks||1.19|0.04|0.079
72628178|NCT03235050|144784451|SUPERIORITY||Odds Ratio, log|0.27||||0.252|TWO_SIDED|95.0|0.03|2.5|||Regression, Logistic|||discontinued IP at 54 wks||2.50|0.03|0.252
72576517|NCT02152605|144679543|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.7|||<|0.001|TWO_SIDED|95.0|-1.1|-0.4|||Mixed Models Analysis|||||-0.4|-1.1|<0.001
72576518|NCT03301649|144679544|EQUIVALENCE|Therapeutic equivalence was demonstrated if 90% CI of percentage difference between generic ivermectin lotion and sklice (ivermectin) lotion group was within the range (-20%, +20%).|Difference in percentage of participants|1.9|||||TWO_SIDED|90.0|-3.9|7.8||||||If the 90% confidence interval (CI) for the absolute difference between the percentage of participants who were considered a treatment success in the generic ivermectin lotion and sklice (ivermectin) lotion was contained within the range (-20%, +20%) then therapeutic equivalence of the generic ivermectin lotion and sklice (ivermectin) lotion was considered to have been demonstrated.||7.8|-3.9|
72576519|NCT03301649|144679545|SUPERIORITY||||||<|0.0001||||||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||Analysis was performed using Cochran- Mantel-Haenszel test, stratified by clinical site in mITT population (using last observation carried forward \[LOCF\] method).||||<0.0001
72628179|NCT03235050|144784451|SUPERIORITY||Odds Ratio, log|0.32||||0.143|TWO_SIDED|95.0|0.07|1.47|||Regression, Logistic|||discontinued IP at 54 wks||1.47|0.07|0.143
72628180|NCT02415556|144784457|OTHER|"A spatial power variance-covariance structure was used to model within-subject correlated measurements where the number of days from the baseline visit was used as the power of the autoregressive correlation coefficient. Each efficacy and safety outcome variable was modeled separately.~The independent variables included: 4 treatment groups, TIMEG (baseline, on-treatment and post-treatment period), TIMEG \* treatment group.; an average number of treatment days; subjects as random effects."|Mean Difference (Final Values)|6.52||||0.025|TWO_SIDED|95.0|0.81|12.23||Mixed model p-value represents on-treatment difference between between Type 2 Diabetes Mellitus - Insulin vs. Type 2 Diabetes Mellitus - Placebo.|Mixed Models Analysis|||We set type-I error rate at 0.05, power of 0.80 or above, effect size of 15% improvement due to INI, and obtained n=120 for the DM group (60 DM-INI; 60 DM-Placebo) and n=90 for the Control group (45 Control-INI; 45 Control-Placebo) yielding 210 patients with data at the end of the treatment period.||12.23|0.81|0.025
72628222|NCT00492557|144784517|NON_INFERIORITY_OR_EQUIVALENCE|The criterion upon which to declare non-inferiority was if the lower limit of the 2-sided 95%CI for the GMT ratios, (13vPnC+TIV relative to 13vPnC administered 1 month after TIV+placebo) was greater than 0.5 (2-fold criterion).|GMT Ratio|0.7|||||TWO_SIDED|95.0|0.42|1.03|||||2-sided 95% CIs for the GMT ratio were calculated by back transformations of the 95% CIs based on the Student t distribution for the mean difference of the logarithmically transformed assay results.|Serotype 9V. The primary null hypothesis was: the log of the GMT in the group receiving 13vPnC + TIV minus the log of the GMT in the group receiving 13vPnC alone (1 month after TIV) \<= -0.693.||1.03|0.42|
72410209|NCT00456092|144328748|SUPERIORITY||Adjusted Mean Difference|4.3||||0.004|TWO_SIDED||||||ANOVA|ANOVA model with treatment, methotrexate use, and interaction of treatment group and methotrexate use as factors with baseline score as the covariate.|The adjusted mean difference (Apremilast-Placebo) is based on an ANOVA model described above.|||||0.004
72410210|NCT00563797|144328768|SUPERIORITY_OR_OTHER|||||||0.014|TWO_SIDED|||||F=7.73|Mixed Models Analysis|||Comparison is between baseline and during treatment.||||0.014
72410211|NCT00563797|144328769|SUPERIORITY_OR_OTHER|||||||0.0001|TWO_SIDED|||||F=36.32|Mixed Models Analysis|||Comparison of baseline and post-treatment||||.0001
72542162|NCT00830063|144614034|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.26|STANDARD_ERROR_OF_MEAN|0.24||0.274|TWO_SIDED|95.0|-0.73|0.21||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 4: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||0.21|-0.73|0.274
72542163|NCT00830063|144614034|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.69|STANDARD_ERROR_OF_MEAN|0.24||0.004|TWO_SIDED|95.0|-1.16|-0.22||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 4: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.22|-1.16|0.004
72576520|NCT03301649|144679545|SUPERIORITY||||||<|0.0001||||||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||Analysis was performed using Cochran- Mantel-Haenszel test, stratified by clinical site in mITT population (using LOCF method).||||<0.0001
72576521|NCT03301649|144679546|EQUIVALENCE|Therapeutic equivalence was demonstrated if 90% CI of percentage difference between generic ivermectin lotion and sklice (ivermectin) lotion group was within the range (-20%, +20%).|Difference in percentage of participants|0.9|||||TWO_SIDED|90.0|-2.6|4.5||||||If the 90% CI for the absolute difference between the percentage of participants who were considered a treatment success in the generic ivermectin lotion and sklice (ivermectin) lotion was contained within the range (-20%, +20%) then therapeutic equivalence of the generic ivermectin lotion and sklice (ivermectin) lotion was considered to have been demonstrated.||4.5|-2.6|
72576522|NCT03301649|144679547|SUPERIORITY||||||<|0.0001||||||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||Analysis was performed using Cochran- Mantel-Haenszel test, stratified by clinical site in mITT population (using LOCF method).||||<0.0001
72576523|NCT03301649|144679547|SUPERIORITY||||||<|0.0001||||||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||Analysis was performed using Cochran- Mantel-Haenszel test, stratified by clinical site in mITT population (using LOCF method).||||<0.0001
72628181|NCT02415556|144784457|OTHER|The independent variables in the model included a four-level indicator variable for the four treatment groups, a three-level time indicator variable (TIMEG) representing baseline, on-treatment and post-treatment period and an interaction term between TIMEG and treatment group. An average number of treatment days at each assessment visit was used as a continuous repeated variable and subjects were included as random effects. Each efficacy and safety outcome variable was modeled separately.|Mean Difference (Final Values)|5.28||||0.051|TWO_SIDED|95.0|-0.03|10.6||Mixed model p-value represents on-treatment difference between between Control - Insulin vs. Control - Placebo.|Mixed Models Analysis|||We set type-I error rate at 0.05, power of 0.80 or above, effect size of 15% improvement due to INI, and obtained n=120 for the DM group (60 DM-INI; 60 DM-Placebo) and n=90 for the Control group (45 Control-INI; 45 Control-Placebo) yielding 210 patients with data at the end of the treatment period.||10.60|-0.03|0.051
72410212|NCT00563797|144328770|SUPERIORITY_OR_OTHER|||||||0.025|TWO_SIDED||||||Mixed Models Analysis|||||||.025
72410213|NCT00563797|144328771|SUPERIORITY_OR_OTHER|||||||0.019|TWO_SIDED||||||Mixed Models Analysis|||||||.019
72410214|NCT02710630|144328772|SUPERIORITY_OR_OTHER||Ratio [Test/Reference]|119.33|STANDARD_DEVIATION|40.4|||TWO_SIDED|90.0|101.838|139.834|||||"The adjusted geometric mean (gMean) ratio \[%\] calculated as Dabigatran Etexilate Tablet: A1/Dabigatran Etexilate Capsule: Ref.~Standard deviation is actually intra-individual geometric coefficient of variation (gCV) \[%\]."|||139.834|101.838|
72410215|NCT02710630|144328772|SUPERIORITY_OR_OTHER||Ratio [Test/Reference]|52.97|STANDARD_DEVIATION|168.9|||TWO_SIDED|90.0|33.341|84.158|||||"The adjusted geometric mean (gMean) ratio \[%\] calculated as Dabigatran Etexilate Tablet: B1/Dabigatran Etexilate Capsule: Ref.~Standard deviation is actually intra-individual geometric coefficient of variation (gCV) \[%\]."|||84.158|33.341|
72410216|NCT02710630|144328772|SUPERIORITY_OR_OTHER||Ratio [Test/Reference]|59.01|STANDARD_DEVIATION|73.4|||TWO_SIDED|90.0|45.255|76.955|||||"The adjusted geometric mean (gMean) ratio \[%\] calculated as Dabigatran Etexilate Tablet: C1/Dabigatran Etexilate Capsule: Ref.~Standard deviation is actually intra-individual geometric coefficient of variation (gCV) \[%\]."|||76.955|45.255|
72410217|NCT02710630|144328772|SUPERIORITY_OR_OTHER||Ratio [Test/Reference]|108.21|STANDARD_DEVIATION|55.7|||TWO_SIDED|90.0|87.698|133.53|||||"The adjusted geometric mean (gMean) ratio \[%\] calculated as Dabigatran Etexilate Tablet: D1/Dabigatran Etexilate Capsule: Ref.~Standard deviation is actually intra-individual geometric coefficient of variation (gCV) \[%\]."|||133.530|87.698|
72542164|NCT00830063|144614034|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.25|STANDARD_ERROR_OF_MEAN|0.25|<|0.001|TWO_SIDED|95.0|-1.74|-0.75||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 8: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.75|-1.74|<0.001
72576524|NCT01917214|144679580|SUPERIORITY_OR_OTHER|||||||0.0308|||||||Log Rank|||||||0.0308
72576525|NCT02814890|144679598|OTHER|difference test||||||0.001|||||||Wilcoxon (Mann-Whitney)|||Sample size: Based on our previous data, pain score at rest 48 hours postoperatively when using ropivacaine only was of 2.8 with a standard deviation of 1.4. Assuming a decrease of pain score by 1.1 being clinically significant, twenty six patents in each group would be required for a study power of 80% (α=0.05,β=0.2). Considering possible dropouts, we aimed at recruiting 30 patients in each group with a total of 60 patients.||||0.001
72576526|NCT02814890|144679599|OTHER|difference test|Kendall's tau-b correlation coefficient|0.47|||||TWO_SIDED|||||||||||||
72576527|NCT02814890|144679601|SUPERIORITY||Risk Ratio (RR)|0.64|||>|0.05|TWO_SIDED||||||Fisher Exact|||||||>0.05
72542165|NCT00830063|144614034|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.5|STANDARD_ERROR_OF_MEAN|0.25|<|0.001|TWO_SIDED|95.0|-2.0|-1.01||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 8: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-1.01|-2.00|<0.001
72542166|NCT00830063|144614034|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.49|STANDARD_ERROR_OF_MEAN|0.25||0.051|TWO_SIDED|95.0|-0.99|0.0||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 8: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||0.00|-0.99|0.051
72542167|NCT00830063|144614034|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.75|STANDARD_ERROR_OF_MEAN|0.25||0.003|TWO_SIDED|95.0|-1.24|-0.25||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 8: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.25|-1.24|0.003
72542168|NCT00830063|144614034|SUPERIORITY_OR_OTHER_LEGACY||-1.59|-1.59|STANDARD_ERROR_OF_MEAN|0.27|<|0.001|TWO_SIDED|95.0|-2.12|-1.07||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 12: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-1.07|-2.12|<0.001
72542169|NCT00830063|144614034|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.37|STANDARD_ERROR_OF_MEAN|0.27|<|0.001|TWO_SIDED|95.0|-1.9|-0.85||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 12: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.85|-1.90|<0.001
72542170|NCT00830063|144614034|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.89|STANDARD_ERROR_OF_MEAN|0.27|<|0.001|TWO_SIDED|95.0|-1.42|-0.37||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 12: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.37|-1.42|<0.001
72542171|NCT00830063|144614034|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.67|STANDARD_ERROR_OF_MEAN|0.27||0.012|TWO_SIDED|95.0|-1.19|-0.15||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 12: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.15|-1.19|0.012
72542172|NCT00830063|144614035|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.51|STANDARD_ERROR_OF_MEAN|0.23||0.026|TWO_SIDED|95.0|-0.96|-0.06||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 2: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.06|-0.96|0.026
72542173|NCT00830063|144614035|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.87|STANDARD_ERROR_OF_MEAN|0.23|<|0.001|TWO_SIDED|95.0|-1.32|-0.43||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 2: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.43|-1.32|<0.001
72628223|NCT00492557|144784517|NON_INFERIORITY_OR_EQUIVALENCE|The criterion upon which to declare non-inferiority was if the lower limit of the 2-sided 95%CI for the GMT ratios, (13vPnC+TIV relative to 13vPnC administered 1 month after TIV+placebo) was greater than 0.5 (2-fold criterion).|GMT Ratio|0.9|||||TWO_SIDED|95.0|0.65|1.24|||||2-sided 95% CIs for the GMT ratio were calculated by back transformations of the 95% CIs based on the Student t distribution for the mean difference of the logarithmically transformed assay results.|Serotype 14. The primary null hypothesis was: the log of the GMT in the group receiving 13vPnC + TIV minus the log of the GMT in the group receiving 13vPnC alone (1 month after TIV) \<= -0.693.||1.24|0.65|
72542174|NCT00830063|144614035|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.22|STANDARD_ERROR_OF_MEAN|0.23||0.333|TWO_SIDED|95.0|-0.23|0.67||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 2: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||0.67|-0.23|0.333
72542175|NCT00830063|144614035|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.14|STANDARD_ERROR_OF_MEAN|0.23||0.527|TWO_SIDED|95.0|-0.59|0.3||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 2: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||0.30|-0.59|0.527
72542176|NCT00830063|144614035|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.03|STANDARD_ERROR_OF_MEAN|0.23|<|0.001|TWO_SIDED|95.0|-1.48|-0.57||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 4: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.57|-1.48|<0.001
72542177|NCT00830063|144614035|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.71|STANDARD_ERROR_OF_MEAN|0.23|<|0.001|TWO_SIDED|95.0|-2.16|-1.25||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 4: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-1.25|-2.16|<0.001
72542178|NCT00830063|144614035|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.13|STANDARD_ERROR_OF_MEAN|0.23||0.574|TWO_SIDED|95.0|-0.58|0.32||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 4: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||0.32|-0.58|0.574
72542179|NCT00830063|144614035|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.81|STANDARD_ERROR_OF_MEAN|0.23|<|0.001|TWO_SIDED|95.0|-1.26|-0.36||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 4: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.36|-1.26|<0.001
72542180|NCT00830063|144614035|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.13|STANDARD_ERROR_OF_MEAN|0.24|<|0.001|TWO_SIDED|95.0|-1.6|-0.67||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 8: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.67|-1.60|<0.001
72542181|NCT00830063|144614035|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.64|STANDARD_ERROR_OF_MEAN|0.24|<|0.001|TWO_SIDED|95.0|-2.1|-1.17||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 8: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-1.17|-2.10|<0.001
72542182|NCT00830063|144614035|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.45|STANDARD_ERROR_OF_MEAN|0.24||0.055|TWO_SIDED|95.0|-0.92|0.01||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 8: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||0.01|-0.92|0.055
72542183|NCT00830063|144614035|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.96|STANDARD_ERROR_OF_MEAN|0.24|<|0.001|TWO_SIDED|95.0|-1.42|-0.49||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 8: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.49|-1.42|<0.001
72542184|NCT00830063|144614035|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.27|STANDARD_ERROR_OF_MEAN|0.24|<|0.001|TWO_SIDED|95.0|-1.75|-0.79||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 12: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.79|-1.75|<0.001
72542185|NCT00830063|144614035|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.47|STANDARD_ERROR_OF_MEAN|0.24|<|0.001|TWO_SIDED|95.0|-1.95|-0.99||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 12: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.99|-1.95|<0.001
72542186|NCT00830063|144614035|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.67|STANDARD_ERROR_OF_MEAN|0.24||0.006|TWO_SIDED|95.0|-1.15|-0.19||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 12: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.19|-1.15|0.006
72542187|NCT00830063|144614035|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.87|STANDARD_ERROR_OF_MEAN|0.24|<|0.001|TWO_SIDED|95.0|-1.34|-0.39||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 12: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.39|-1.34|<0.001
72542188|NCT00830063|144614036|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.16|STANDARD_ERROR_OF_MEAN|0.08||0.045|TWO_SIDED|95.0|-0.32|0.0||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 2: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.00|-0.32|0.045
72542189|NCT00830063|144614036|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.18|STANDARD_ERROR_OF_MEAN|0.08||0.03|TWO_SIDED|95.0|-0.33|-0.02||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 2: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.02|-0.33|0.030
72542190|NCT00830063|144614036|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.18|STANDARD_ERROR_OF_MEAN|0.08||0.027|TWO_SIDED|95.0|0.02|0.34||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 2: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||0.34|0.02|0.027
72542191|NCT00830063|144614036|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.17|STANDARD_ERROR_OF_MEAN|0.08||0.04|TWO_SIDED|95.0|0.01|0.32||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 2: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||0.32|0.01|0.040
72542192|NCT00830063|144614036|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.51|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-0.66|-0.35||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 4: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.35|-0.66|<0.001
72542193|NCT00830063|144614036|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.56|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-0.72|-0.41||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 4: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.41|-0.72|<0.001
72542194|NCT00830063|144614036|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.16|STANDARD_ERROR_OF_MEAN|0.08||0.041|TWO_SIDED|95.0|-0.32|-0.01||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 4: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.01|-0.32|0.041
72542195|NCT00830063|144614036|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.22|STANDARD_ERROR_OF_MEAN|0.08||0.006|TWO_SIDED|95.0|-0.38|-0.06||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 4: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.06|-0.38|0.006
72542196|NCT00830063|144614036|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.44|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-0.6|-0.27||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 8: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.27|-0.60|<0.001
72542197|NCT00830063|144614036|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.45|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-0.62|-0.29||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 8: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.29|-0.62|<0.001
72542198|NCT00830063|144614036|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.22|STANDARD_ERROR_OF_MEAN|0.08||0.011|TWO_SIDED|95.0|-0.38|-0.05||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 8: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.05|-0.38|0.011
72542199|NCT00830063|144614036|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.23|STANDARD_ERROR_OF_MEAN|0.08||0.006|TWO_SIDED|95.0|-0.4|-0.07||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 8: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.07|-0.40|0.006
72542200|NCT00830063|144614036|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.43|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-0.6|-0.26||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 12: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.26|-0.60|<0.001
72542201|NCT00830063|144614036|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.31|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-0.48|-0.14||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 12: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference||-0.14|-0.48|<0.001
72542202|NCT00830063|144614036|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.26|STANDARD_ERROR_OF_MEAN|0.08||0.003|TWO_SIDED|95.0|-0.42|-0.09||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 12: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.09|-0.42|0.003
72628182|NCT02415556|144784458|OTHER|The independent variables in the model included a four-level indicator variable for the four treatment groups, a three-level time indicator variable (TIMEG) representing baseline, on-treatment and post-treatment period and an interaction term between TIMEG and treatment group. An average number of treatment days at each assessment visit was used as a continuous repeated variable and subjects were included as random effects. Each efficacy and safety outcome variable was modeled separately.|Mean Difference (Final Values)|8.31||||0.007|TWO_SIDED|95.0|2.33|14.29||Mixed model p-value represents on-treatment difference between between Type 2 Diabetes Mellitus - Insulin vs. Type 2 Diabetes Mellitus - Placebo.|Mixed Models Analysis|||We set type-I error rate at 0.05, power of 0.80 or above, effect size of 15% improvement due to INI, and obtained n=120 for the DM group (60 DM-INI; 60 DM-Placebo) and n=90 for the Control group (45 Control-INI; 45 Control-Placebo) yielding 210 patients with data at the end of the treatment period.||14.29|2.33|0.007
72542203|NCT00830063|144614036|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.14|STANDARD_ERROR_OF_MEAN|0.08||0.105|TWO_SIDED|95.0|-0.3|0.03||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 12: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||0.03|-0.30|0.105
72628183|NCT02415556|144784458|OTHER|The independent variables in the model included a four-level indicator variable for the four treatment groups, a three-level time indicator variable (TIMEG) representing baseline, on-treatment and post-treatment period and an interaction term between TIMEG and treatment group. An average number of treatment days at each assessment visit was used as a continuous repeated variable and subjects were included as random effects. Each efficacy and safety outcome variable was modeled separately.|Mean Difference (Final Values)|2.71||||0.342|TWO_SIDED|95.0|-2.9|8.32||Mixed model p-value represents on-treatment difference between between Control - Insulin vs. Control - Placebo.|Mixed Models Analysis|||We set type-I error rate at 0.05, power of 0.80 or above, effect size of 15% improvement due to INI, and obtained n=120 for the DM group (60 DM-INI; 60 DM-Placebo) and n=90 for the Control group (45 Control-INI; 45 Control-Placebo) yielding 210 patients with data at the end of the treatment period.||8.32|-2.90|0.342
72628184|NCT02415556|144784459|OTHER|The independent variables in the model included a four-level indicator variable for the four treatment groups, a three-level time indicator variable (TIMEG) representing baseline, on-treatment and post-treatment period and an interaction term between TIMEG and treatment group. An average number of treatment days at each assessment visit was used as a continuous repeated variable and subjects were included as random effects. Each efficacy and safety outcome variable was modeled separately.|Mean Difference (Final Values)|-0.37||||0.144|TWO_SIDED|95.0|-0.87|0.13||Mixed model p-value represents on-treatment difference between between Type 2 Diabetes Mellitus - Insulin vs. Type 2 Diabetes Mellitus - Placebo.|Mixed Models Analysis|||We set type-I error rate at 0.05, power of 0.80 or above, effect size of 15% improvement due to INI, and obtained n=120 for the DM group (60 DM-INI; 60 DM-Placebo) and n=90 for the Control group (45 Control-INI; 45 Control-Placebo) yielding 210 patients with data at the end of the treatment period.||0.13|-0.87|0.144
72628185|NCT02415556|144784459|OTHER|The independent variables in the model included a four-level indicator variable for the four treatment groups, a three-level time indicator variable (TIMEG) representing baseline, on-treatment and post-treatment period and an interaction term between TIMEG and treatment group. An average number of treatment days at each assessment visit was used as a continuous repeated variable and subjects were included as random effects. Each efficacy and safety outcome variable was modeled separately.|Mean Difference (Final Values)|-0.64||||0.008|TWO_SIDED|95.0|-1.11|-0.16||Mixed model p-value represents on-treatment difference between between Control - Insulin vs. Control - Placebo.|Mixed Models Analysis|||We set type-I error rate at 0.05, power of 0.80 or above, effect size of 15% improvement due to INI, and obtained n=120 for the DM group (60 DM-INI; 60 DM-Placebo) and n=90 for the Control group (45 Control-INI; 45 Control-Placebo) yielding 210 patients with data at the end of the treatment period.||-0.16|-1.11|0.008
72628186|NCT02415556|144784460|OTHER|The independent variables in the model included a four-level indicator variable for the four treatment groups, a three-level time indicator variable (TIMEG) representing baseline, on-treatment and post-treatment period and an interaction term between TIMEG and treatment group. An average number of treatment days at each assessment visit was used as a continuous repeated variable and subjects were included as random effects. Each efficacy and safety outcome variable was modeled separately.|Mean Difference (Final Values)|0.35||||0.149|TWO_SIDED|95.0|-0.13|0.83||Mixed model p-value represents on-treatment difference between between Type 2 Diabetes Mellitus - Insulin vs. Type 2 Diabetes Mellitus - Placebo.|Mixed Models Analysis|||We set type-I error rate at 0.05, power of 0.80 or above, effect size of 15% improvement due to INI, and obtained n=120 for the DM group (60 DM-INI; 60 DM-Placebo) and n=90 for the Control group (45 Control-INI; 45 Control-Placebo) yielding 210 patients with data at the end of the treatment period.||0.83|-0.13|0.149
72628187|NCT02415556|144784460|OTHER|The independent variables in the model included a four-level indicator variable for the four treatment groups, a three-level time indicator variable (TIMEG) representing baseline, on-treatment and post-treatment period and an interaction term between TIMEG and treatment group. An average number of treatment days at each assessment visit was used as a continuous repeated variable and subjects were included as random effects. Each efficacy and safety outcome variable was modeled separately.|Mean Difference (Final Values)|0.35||||0.134|TWO_SIDED|95.0|-0.11|0.8||Mixed model p-value represents on-treatment difference between between Control - Insulin vs. Control - Placebo.|Mixed Models Analysis|||We set type-I error rate at 0.05, power of 0.80 or above, effect size of 15% improvement due to INI, and obtained n=120 for the DM group (60 DM-INI; 60 DM-Placebo) and n=90 for the Control group (45 Control-INI; 45 Control-Placebo) yielding 210 patients with data at the end of the treatment period.||0.80|-0.11|0.134
72628188|NCT02415556|144784461|OTHER|The independent variables in the model included a four-level indicator variable for the four treatment groups, a three-level time indicator variable (TIMEG) representing baseline, on-treatment and post-treatment period and an interaction term between TIMEG and treatment group. An average number of treatment days at each assessment visit was used as a continuous repeated variable and subjects were included as random effects. Each efficacy and safety outcome variable was modeled separately.|Mean Difference (Final Values)|10.29||||0.03|TWO_SIDED|95.0|1.0|19.58|||Mixed Models Analysis|||||19.58|1.00|0.030
72628189|NCT02415556|144784461|OTHER|See primary aims.|Mean Difference (Final Values)|2.21||||0.607|TWO_SIDED|95.0|-6.22|10.63||See primary aims.|Mixed Models Analysis|||See primary aims.||10.63|-6.22|0.607
72628190|NCT02415556|144784462|OTHER|See primary aims.|Mean Difference (Final Values)|-2.1||||0.576|TWO_SIDED|95.0|-9.5|5.29||See primary aims.|Mixed Models Analysis|||See primary aims.||5.29|-9.50|0.576
72542204|NCT00830063|144614037|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.16|STANDARD_ERROR_OF_MEAN|0.08||0.045|TWO_SIDED|95.0|-0.32|0.0||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 2: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.00|-0.32|0.045
72410218|NCT02710630|144328772|SUPERIORITY_OR_OTHER||Ratio|110.21|STANDARD_DEVIATION|41.1|||TWO_SIDED|90.0|93.939|129.297|||||"The adjusted geometric mean (gMean) ratio \[%\] calculated as Dabigatran Etexilate Tablet: E1/Dabigatran Etexilate Capsule: Ref.~Standard deviation is actually intra-individual geometric coefficient of variation (gCV) \[%\]."|||129.297|93.939|
72542205|NCT00830063|144614037|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.18|STANDARD_ERROR_OF_MEAN|0.08||0.03|TWO_SIDED|95.0|-0.33|-0.02||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 2: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.02|-0.33|0.030
72542206|NCT00830063|144614037|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.18|STANDARD_ERROR_OF_MEAN|0.08||0.027|TWO_SIDED|95.0|0.02|0.34||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 2: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||0.34|0.02|0.027
72628191|NCT02415556|144784462|OTHER|See primary aims.|Mean Difference (Final Values)|-0.86||||0.802|TWO_SIDED|95.0|-7.58|5.87||See primary aims.|Mixed Models Analysis|||See primary aims.||5.87|-7.58|0.802
72628192|NCT02415556|144784463|EQUIVALENCE|CBF and vasoreactivity maps were analyzed on a voxel-by-voxel basis using Statistical non-Parametric Mapping (SnPM, http://www.sph.umich.edu/ni-stat/SnPM/), voxel-level threshold p \< 0.005.||||||0.03|||||||Voxel-Based Morphometry|||||||0.03
72628193|NCT01621178|144784466|NON_INFERIORITY|Non-Inferiority to Glargine with a 0.4% margin|Mean Difference (Final Values)|-0.05|||<|0.001|TWO_SIDED|95.0|-0.26|0.15|||Mixed Models Analysis|||Week 26||0.15|-0.26|<0.001
72628194|NCT01621178|144784466|NON_INFERIORITY|Non-Inferiority to Glargine with a 0.4% margin|Mean Difference (Final Values)|0.02|||<|0.001|TWO_SIDED|95.0|-0.18|0.22|||Mixed Models Analysis|||Week 26||0.22|-0.18|<0.001
72628195|NCT02896257|144784504|SUPERIORITY||Odds Ratio (OR)|3.66|||<|0.001|TWO_SIDED|95.0|2.5|5.38|||Regression, Logistic|Mixed-random effects for provider clustering and adjusting for smoking status. Multiple imputation by chained equations for missing smoking status.||||5.38|2.50|<0.001
72628196|NCT02896257|144784505|SUPERIORITY||Odds Ratio (OR)|0.8||||0.47|TWO_SIDED|95.0|0.44|1.47|||Regression, Logistic|Mixed-random effects for provider clustering and adjusting for smoking status. Multiple imputation by chained equations for missing smoking status.||||1.47|0.44|0.47
72628197|NCT02896257|144784506|SUPERIORITY||Odds Ratio (OR)|0.63||||0.42|TWO_SIDED|95.0|0.2|1.96|||Regression, Logistic|Mixed-random effects for provider clustering and adjusting for smoking status. Multiple imputation by chained equations for missing smoking status.||||1.96|0.20|0.42
72628198|NCT02465931|144784512|OTHER|||||||0.89|||||||t-test, 1 sided|||||||0.89
72628199|NCT00492557|144784513|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for a given virus subtype was demonstrated if the lower bound of the 2-sided, 95% confidence interval (CI), computed using the Chan and Zhang procedure, for the difference in proportions (13vPnC+TIV - TIV alone) was greater than -0.10.|Percent Difference|1.7|||||TWO_SIDED|95.0|-3.1|6.5||||||Influenza virus subtype: A/H1N1. Primary null hypothesis for each of the influenza virus subtypes is: proportion of participants achieving a 4-fold increase in titer when 13vPnC+TIV were administered concomitantly, minus the proportion of participants achieving a 4-fold increase in titer when TIV was administered alone (with placebo) \<= -0.10.||6.5|-3.1|
72628200|NCT00492557|144784513|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for a given virus subtype was demonstrated if the lower bound of the 2-sided, 95% CI, computed using the Chan and Zhang procedure, for the difference in proportions (13vPnC+TIV - TIV alone) was greater than -0.10.|Percent Difference|-4.6|||||TWO_SIDED|95.0|-10.4|1.3||||||Influenza virus subtype: A/H3N2. Primary null hypothesis for each of the influenza virus subtypes is: proportion of participants achieving a 4-fold increase in titer when 13vPnC+TIV were administered concomitantly, minus the proportion of participants achieving a 4-fold increase in titer when TIV was administered alone (with placebo) \<= -0.10.||1.3|-10.4|
72628201|NCT00492557|144784513|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for a given virus subtype was demonstrated if the lower bound of the 2-sided, 95% CI, computed using the Chan and Zhang procedure, for the difference in proportions (13vPnC+TIV - TIV alone) was greater than -0.10.|Percent Difference|-1.8|||||TWO_SIDED|95.0|-7.8|4.1||||||Influenza virus subtype: B. Primary null hypothesis for each of the influenza virus subtypes is: proportion of participants achieving a 4-fold increase in titer when 13vPnC+TIV were administered concomitantly, minus the proportion of participants achieving a 4-fold increase in titer when TIV was administered alone (with placebo) \<= -0.10.||4.1|-7.8|
72410219|NCT02710630|144328773|SUPERIORITY_OR_OTHER||Ratio [Test/Reference]|118.31|STANDARD_DEVIATION|44.2|||TWO_SIDED|90.0|99.569|140.579|||||"The adjusted geometric mean (gMean) ratio \[%\] calculated as Dabigatran Etexilate Tablet: A1/Dabigatran Etexilate Capsule: Ref.~Standard deviation is actually intra-individual geometric coefficient of variation (gCV) \[%\]."|||140.579|99.569|
72410220|NCT02710630|144328773|SUPERIORITY_OR_OTHER||Ratio [Test/Reference]|57.49|STANDARD_DEVIATION|132.3|||TWO_SIDED|90.0|38.502|85.837|||||"The adjusted geometric mean (gMean) ratio \[%\] calculated as Dabigatran Etexilate Tablet: B1/Dabigatran Etexilate Capsule: Ref.~Standard deviation is actually intra-individual geometric coefficient of variation (gCV) \[%\]."|||85.837|38.502|
72542207|NCT00830063|144614037|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.17|STANDARD_ERROR_OF_MEAN|0.08||0.04|TWO_SIDED|95.0|0.01|0.32||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 2: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||0.32|0.01|0.040
72542208|NCT00830063|144614037|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.48|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-0.64|-0.32||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 4: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.32|-0.64|<0.001
72542209|NCT00830063|144614037|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.58|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-0.74|-0.42||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 4: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.42|-0.74|<0.001
72542210|NCT00830063|144614037|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.14|STANDARD_ERROR_OF_MEAN|0.08||0.094|TWO_SIDED|95.0|-0.3|0.02||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 4: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||0.02|-0.30|0.094
72542211|NCT00830063|144614037|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.24|STANDARD_ERROR_OF_MEAN|0.08||0.003|TWO_SIDED|95.0|-0.4|-0.08||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 4: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.08|-0.40|0.003
72542212|NCT00830063|144614037|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-0.57|-0.23||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 8: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.23|-0.57|<0.001
72542213|NCT00830063|144614037|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.51|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-0.68|-0.35||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 8: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.35|-0.68|<0.001
72542214|NCT00830063|144614037|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.18|STANDARD_ERROR_OF_MEAN|0.08||0.032|TWO_SIDED|95.0|-0.35|-0.02||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 8: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.02|-0.35|0.032
72542215|NCT00830063|144614037|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.29|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-0.46|-0.13||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 8: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.13|-0.46|<0.001
72542216|NCT00830063|144614037|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.38|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-0.54|-0.21||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 12: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.21|-0.54|<0.001
72542217|NCT00830063|144614037|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.36|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-0.52|-0.19||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 12: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.19|-0.52|<0.001
72542218|NCT00830063|144614037|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.21|STANDARD_ERROR_OF_MEAN|0.08||0.012|TWO_SIDED|95.0|-0.38|-0.05||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 12: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.05|-0.38|0.012
72542219|NCT00830063|144614037|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.08||0.021|TWO_SIDED|95.0|-0.36|-0.03||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 12: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.03|-0.36|0.021
72542220|NCT01314703|144614075|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.85|STANDARD_ERROR_OF_MEAN|0.089|||TWO_SIDED|95.0|2.66|3.02|||ANOVA||ChloraPrep 10 minute abdomen|Hypothesis: ChloraPrep will exceed 3 log 10 reduction for the groin at 10 minutes and 2 log 10 reduction for the abdomen at 10 minutes. The 70% Isopropyl Alcohol was used as a positive control. All calculations were performed after taking the base-10 logarithm of the original values. The model was a mixed model Analysis of Variance (ANOVA).||3.02|2.66|
72542221|NCT01314703|144614075|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.038|STANDARD_ERROR_OF_MEAN|0.149|||TWO_SIDED|95.0|3.74|4.33|||ANOVA||ChloraPrep 10 minute groin|Hypothesis: ChloraPrep will exceed 3 log 10 reduction for the groin at 10 minutes and 2 log 10 reduction for the abdomen at 10 minutes. The 70% Isopropyl Alcohol was used as a positive control. All calculations were performed after taking the base-10 logarithm of the original values. The model was a mixed model Analysis of Variance (ANOVA).||4.33|3.74|
72542222|NCT01314703|144614075|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.53|STANDARD_ERROR_OF_MEAN|0.089|||TWO_SIDED|95.0|2.36|2.7|||ANOVA||70%Isopropyl Alcohol 10 minute abdomen|Hypothesis: ChloraPrep will exceed 3 log 10 reduction for the groin at 10 minutes and 2 log 10 reduction for the abdomen at 10 minutes. The 70% Isopropyl Alcohol was used as a positive control. All calculations were performed after taking the base-10 logarithm of the original values. The model was a mixed model Analysis of Variance (ANOVA).||2.70|2.36|
72410221|NCT02710630|144328773|SUPERIORITY_OR_OTHER||Ratio [Test/Reference]|61.94|STANDARD_DEVIATION|69.0|||TWO_SIDED|90.0|48.13|79.72|||||"The adjusted geometric mean (gMean) ratio \[%\] calculated as Dabigatran Etexilate Tablet: C1/Dabigatran Etexilate Capsule: Ref.~Standard deviation is actually intra-individual geometric coefficient of variation (gCV) \[%\]."|||79.720|48.130|
72410222|NCT02710630|144328773|SUPERIORITY_OR_OTHER||Ratio [Test/Reference]|108.26|STANDARD_DEVIATION|55.8|||TWO_SIDED|90.0|87.704|133.629|||||"The adjusted geometric mean (gMean) ratio \[%\] calculated as Dabigatran Etexilate Tablet: D1/Dabigatran Etexilate Capsule: Ref.~Standard deviation is actually intra-individual geometric coefficient of variation (gCV) \[%\]."|||133.629|87.704|
72542223|NCT01314703|144614075|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.53|STANDARD_ERROR_OF_MEAN|0.149|||TWO_SIDED|95.0|3.24|3.82|||ANOVA||70% Isopropyl Alcohol 10 minute groin|Hypothesis: ChloraPrep will exceed 3 log 10 reduction for the groin at 10 minutes and 2 log 10 reduction for the abdomen at 10 minutes. The 70% Isopropyl Alcohol was used as a positive control. All calculations were performed after taking the base-10 logarithm of the original values. The model was a mixed model Analysis of Variance (ANOVA).||3.82|3.24|
72542224|NCT01965535|144614191|SUPERIORITY_OR_OTHER||difference in proportions|1.4|||||TWO_SIDED|95.0|-5.9|8.6|||||The 2-sided 95% confidence interval (CI) on the difference in SVR12 rates between the 2 treatment groups was constructed based on stratum-adjusted Mantel-Haenszel (MH) proportions.|A sample size of 75 subjects in each treatment group would provide 80% power to detect a difference of 15% in SVR12 rates (80% vs 95%) between the 2 treatment groups.||8.6|-5.9|
72542225|NCT01493531|144614230|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.32|STANDARD_ERROR_OF_MEAN|0.05|<|0.0001|TWO_SIDED|95.0|0.23|0.41|||Cochran-Mantel-Haenszel|||||0.41|0.23|<0.0001
72542226|NCT01493531|144614230|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.43|STANDARD_ERROR_OF_MEAN|0.05|<|0.0001|TWO_SIDED|95.0|0.34|0.52|||Cochran-Mantel-Haenszel|||||0.52|0.34|<0.0001
72542227|NCT01493531|144614231|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.88||||0.5716|TWO_SIDED|95.0|0.57|1.37|||Negative Binomial Regression|||||1.37|0.57|0.5716
72542228|NCT01493531|144614231|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.93||||0.7454|TWO_SIDED|95.0|0.6|1.45|||Negative Binomial Regression|||||1.45|0.60|0.7454
72576528|NCT00741286|144679609|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0|||||Mixed Models Analysis|||A linear mixed model for a repeated measures covariance pattern model with unstructured covariances within subjects was used. Two fixed effects were included: 1 between-subjects treatment effect (group: cilostazol, control) and 1 within-subject time effect (time: baseline, 14 days, 90 days). A possible difference in treatment across 14- and 90-day follow-up was analyzed by time x treatment interactions.||||<0.05
72576529|NCT00741286|144679609|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0|||||t-test, 2 sided|||To determine between-group differences of changes in the PIs at 14 and 90 days from the baseline study.||||<0.05
72628202|NCT00492557|144784514|NON_INFERIORITY_OR_EQUIVALENCE|The criterion upon which to declare non-inferiority was the lower bound of the 2-sided, 95% CI for the geometric mean ratio greater than 0.5 (2-fold criterion).|Ratio of GMCs|0.79|||||TWO_SIDED|95.0|0.6|1.04|||||CIs for the ratio were back transformations of the CIs based on the Student t distribution for the mean difference of the logarithmically transformed assay results.|Serotype 1. The primary null hypothesis was: the log of the GMC in the group receiving 13vPnC and TIV concomitantly, minus the log of the GMC in the group receiving 13vPnC alone (1 month after TIV) \<= -0.693.||1.04|0.60|
72410223|NCT02710630|144328773|SUPERIORITY_OR_OTHER||Ratio [Test/Reference]|107.76|STANDARD_DEVIATION|43.0|||TWO_SIDED|90.0|91.238|127.281|||||"The adjusted geometric mean (gMean) ratio \[%\] calculated as Dabigatran Etexilate Tablet: E1/Dabigatran Etexilate Capsule: Ref.~Standard deviation is actually intra-individual geometric coefficient of variation (gCV) \[%\]."|||127.281|91.238|
72542229|NCT01493531|144614232|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.02||||0.8466|TWO_SIDED|95.0|-0.24|0.2|||Cochran-Mantel-Haenszel|||||0.2|-0.24|0.8466
72542230|NCT01493531|144614232|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.06||||0.6301|TWO_SIDED|95.0|-0.29|0.17|||Cochran-Mantel-Haenszel|||||0.17|-0.29|0.6301
72542231|NCT01946282|144614233|EQUIVALENCE|Assuming a FIT return rate of 29% for the outreach only group at an a=0.05, we estimated more than 90% power to detect an absolute difference greater than 5% when using a chi-square test of proportions to compare patients who received any incentive ($5 or $10) compared with patients who received outreach only.||||||0.59|||||||Chi-squared|||||||0.59
72576530|NCT00741286|144679610|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0|||||Chi-squared|||||||<0.05
72576531|NCT02318303|144679623|SUPERIORITY||Mean Difference (Final Values)|-1.1087|||<|0.0001|TWO_SIDED|97.5|-1.669|-0.5485|||ANCOVA|||||-0.5485|-1.6690|<0.0001
72576532|NCT02318303|144679623|SUPERIORITY||Mean Difference (Final Values)|-1.1703|||<|0.0001|TWO_SIDED|97.5|-1.7315|-0.609|||ANCOVA|||||-0.6090|-1.7315|<0.0001
72576533|NCT02318303|144679623|SUPERIORITY||Mean Difference (Final Values)|-0.7718||||0.002|TWO_SIDED|95.0|-1.2616|-0.282|||ANCOVA|||||-0.2820|-1.2616|0.0020
72576534|NCT02318303|144679623|SUPERIORITY||Mean Difference (Final Values)|-0.3563||||0.1524|TWO_SIDED|95.0|-0.8445|0.1319|||ANCOVA|||||0.1319|-0.8445|0.1524
72542232|NCT01946282|144614233|EQUIVALENCE|Assuming a FIT return rate of 29% for the outreach only group at an a=0.05, we estimated more than 90% power to detect an absolute difference greater than 5% when using a chi-square test of proportions to compare patients who received any incentive ($5 or $10) compared with patients who received outreach only.||||||0.75|||||||Chi-squared|||||||.75
72542233|NCT01946282|144614233|EQUIVALENCE|Assuming a FIT return rate of 29% for the outreach only group at an a=0.05, we estimated more than 90% power to detect an absolute difference greater than 5% when using a chi-square test of proportions to compare patients who received any incentive ($5 or $10) compared with patients who received outreach only.||||||0.08|||||||Chi-squared|||||||.080
72542234|NCT01946282|144614234|EQUIVALENCE|Based on design, at a significance level of 0.05 group size was set to detect an minimum absolute difference in return rate of 10%, while maintaining more than 90% power. Baseline return rates were projected per group using prior study data: 29% for the outreach only group, 45% in the $5 incentive group, and 53% in the $10 incentive group.||||||0.07|||||||Chi-squared|||||||0.070
72542235|NCT01946282|144614234|EQUIVALENCE|Based on design, at a significance level of 0.05 group size was set to detect an minimum absolute difference in return rate of 10%, while maintaining more than 90% power. Baseline return rates were projected per group using prior study data: 29% for the outreach only group, 45% in the $5 incentive group, and 53% in the $10 incentive group.||||||0.8|||||||Chi-squared|||||||0.80
72542236|NCT01946282|144614234|EQUIVALENCE|Based on design, at a significance level of 0.05 group size was set to detect an minimum absolute difference in return rate of 10%, while maintaining more than 90% power. Baseline return rates were projected per group using prior study data: 29% for the outreach only group, 45% in the $5 incentive group, and 53% in the $10 incentive group.||||||0.6|||||||Chi-squared|||||||0.60
72576535|NCT02318303|144679623|SUPERIORITY||Mean Difference (Final Values)|-0.4918||||0.0488|TWO_SIDED|95.0|-0.981|-0.0025|||ANCOVA|||||-0.0025|-0.9810|0.0488
72576536|NCT02318303|144679623|SUPERIORITY||Mean Difference (Final Values)|-0.7133||||0.0043|TWO_SIDED|95.0|-1.2031|-0.2235|||ANCOVA|||||-0.2235|-1.2031|0.0043
72628203|NCT00492557|144784514|NON_INFERIORITY_OR_EQUIVALENCE|The criterion upon which to declare non-inferiority was the lower bound of the 2-sided, 95% CI for the geometric mean ratio greater than 0.5 (2-fold criterion).|Ratio of GMCs|0.94|||||TWO_SIDED|95.0|0.78|1.13|||||CIs for the ratio were back transformations of the CIs based on the Student t distribution for the mean difference of the logarithmically transformed assay results.|Serotype 3. The primary null hypothesis was: the log of the GMC in the group receiving 13vPnC and TIV concomitantly, minus the log of the GMC in the group receiving 13vPnC alone (1 month after TIV) \<= -0.693.||1.13|0.78|
72410224|NCT02710630|144328774|SUPERIORITY_OR_OTHER||Ratio [Test/Reference]|118.26|STANDARD_DEVIATION|38.5|||TWO_SIDED|90.0|101.627|137.621|||||"The adjusted geometric mean (gMean) ratio \[%\] calculated as Dabigatran Etexilate Tablet: A1/Dabigatran Etexilate Capsule: Ref.~Standard deviation is actually intra-individual geometric coefficient of variation (gCV) \[%\]."|||137.621|101.627|
72542237|NCT01946282|144614234|EQUIVALENCE|Based on design, at a significance level of 0.05 group size was set to detect an minimum absolute difference in return rate of 10%, while maintaining more than 90% power. Baseline return rates were projected per group using prior study data: 29% for the outreach only group, 45% in the $5 incentive group, and 53% in the $10 incentive group.||||||0.31|||||||Chi-squared|||||||0.31
72542238|NCT01946282|144614234|EQUIVALENCE|Based on design, at a significance level of 0.05 group size was set to detect an minimum absolute difference in return rate of 10%, while maintaining more than 90% power. Baseline return rates were projected per group using prior study data: 29% for the outreach only group, 45% in the $5 incentive group, and 53% in the $10 incentive group.||||||0.82|||||||Chi-squared|||||||0.82
72542239|NCT01946282|144614234|EQUIVALENCE|Based on design, at a significance level of 0.05 group size was set to detect an minimum absolute difference in return rate of 10%, while maintaining more than 90% power. Baseline return rates were projected per group using prior study data: 29% for the outreach only group, 45% in the $5 incentive group, and 53% in the $10 incentive group.||||||0.033|||||||Chi-squared|||||||0.033
72542240|NCT01946282|144614234|EQUIVALENCE|We estimated needing 545 observations per incentive group to achieve power necessary to detect at least a 10% absolute difference in FIT return rate between patients who received the $5 incentive versus patients who received the $10 incentive, with assumed rates of 45% in the $5 incentive group and 53% in the $10 incentive group, a=0.05, and power=90%.||||||0.033|||||||Chi-squared|||||||0.033
72542241|NCT01946282|144614234|EQUIVALENCE||||||>|0.99|||||||Chi-squared|||||||>0.99
72542242|NCT01946282|144614234|EQUIVALENCE|||||||0.184|||||||Chi-squared|||||||0.184
72542243|NCT00845026|144614240|SUPERIORITY_OR_OTHER_LEGACY|||||||0.184||95.0||||No adjustments were made for multiplicity. All treatment comparisons were evaluated based on a two-sided significance level of 0.05.|Log Rank|||||||0.184
72576537|NCT00314951|144679624|NON_INFERIORITY_OR_EQUIVALENCE|The point estimate of the difference and the 2-sided 95% confidence interval (CI) for the difference between treatment groups were computed. If the lower limit of the CI was greater than -10%, the clinical non-inferiority of fidaxomicin was demonstrated. CIs for the difference of cure rates were calculated using the method recommended by Agresti and Caffo.|Risk Difference (RD)|2.6|||||TWO_SIDED|95.0|-2.9|8.0||||||H0: C(fidaxomicin) - C(Vancomycin) \<= -10% Power calculation is based on cure rate of 85% in both treatment groups, non-inferiority margin of 10%, 2.5% (1-sided) type I error rate with approximately 90% power gives a total of 530 subjects.||8.0|-2.9|
72576538|NCT00314951|144679625|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-9.4||||0.008|TWO_SIDED|95.0|-16.2|-2.5|||Chi-squared|||||-2.5|-16.2|0.008
72576539|NCT00314951|144679626|SUPERIORITY_OR_OTHER||Risk Difference (RD)|10.2||||0.007|TWO_SIDED|95.0|2.8|17.5|||Chi-squared|||||17.5|2.8|0.007
72576540|NCT01120704|144679653|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.906||||0.045|TWO_SIDED|95.0|0.822|0.998|||Regression, Cox|||The Cox regression model effects consisted of five treatment effects, 10 two-way treatment interactions, 10 three-way treatment interactions, and two covariates : two items from the Fagerstrom Test of Nicotine Dependence (Item 1: time to first cigarette; Item 4: cigarettes per day).||.998|.822|.045
72576541|NCT01120704|144679653|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.982||||0.705|TWO_SIDED|95.0|0.892|1.081|||Regression, Cox|||The Cox regression model effects consisted of five treatment effects, 10 two-way treatment interactions, 10 three-way treatment interactions, and two covariates : two items from the Fagerstrom Test of Nicotine Dependence (Item 1: time to first cigarette; Item 4: cigarettes per day).||1.081|.892|.705
72576542|NCT01120704|144679653|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.044||||0.382|TWO_SIDED|95.0|0.948|1.149|||Regression, Cox|||The Cox regression model effects consisted of five treatment effects, 10 two-way treatment interactions, 10 three-way treatment interactions, and two covariates : two items from the Fagerstrom Test of Nicotine Dependence (Item 1: time to first cigarette; Item 4: cigarettes per day).||1.149|.948|.382
72576543|NCT01120704|144679653|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.954||||0.339|TWO_SIDED|95.0|0.867|1.05|||Regression, Cox|||The Cox regression model effects consisted of five treatment effects, 10 two-way treatment interactions, 10 three-way treatment interactions, and two covariates : two items from the Fagerstrom Test of Nicotine Dependence (Item 1: time to first cigarette; Item 4: cigarettes per day).||1.050|.867|.339
72576544|NCT01120704|144679653|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.945||||0.248|TWO_SIDED|95.0|0.858|1.04|||Regression, Cox|||||1.040|.858|.248
72576545|NCT01120704|144679654|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.402||||0.011|TWO_SIDED|95.0|1.08|1.821|||Regression, Logistic|||The logistic regression model effects consisted of five treatment main effects and all treatment interactions. The main effects provide direct tests of the primary aim of the study, i.e., determining whether or not more intensive treatments (compared to less intensive treatments; e.g., 8 Weeks of Nicotine Patch and Nicotine Gum vs. 26 Weeks of Nicotine Patch and Nicotine Gum) would result in significantly higher abstinence at 52 weeks after target quit day.||1.821|1.080|.011
72576546|NCT01120704|144679654|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.008||||0.956|TWO_SIDED|95.0|0.769|1.321|||Regression, Logistic|||The logistic regression model effects consisted of five treatment main effects and all treatment interactions. The main effects provide direct tests of the primary aim of the study, i.e., determining whether or not more intensive treatments (compared to less intensive treatments; e.g., No Maintenance Counseling vs. Maintenance Counseling) would result in significantly higher abstinence at 52 weeks after target quit day.||1.321|.769|.956
72576547|NCT01120704|144679654|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.018||||0.885|TWO_SIDED|95.0|0.797|1.301|||Regression, Logistic|||The logistic regression model effects consisted of five treatment main effects and all treatment interactions. The main effects provide direct tests of the primary aim of the study, i.e., determining whether or not more intensive treatments (compared to less intensive treatments; e.g., No Cognitive Medication Adherence Counseling vs. Cognitive Medication Adherence Counseling) would result in significantly higher abstinence at 52 weeks after target quit day.||1.301|.797|.885
72576548|NCT01120704|144679654|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.852||||0.205|TWO_SIDED|95.0|0.664|1.092|||Regression, Logistic|||The logistic regression model effects consisted of five treatment main effects and all treatment interactions. The main effects provide direct tests of the primary aim of the study, i.e., determining whether or not more intensive treatments (compared to less intensive treatments; e.g., Electronic Medication Monitoring Device Without Feedback vs. Electronic Medication Monitoring Device Plus Feedback) would result in significantly higher abstinence at 52 weeks after target quit day.||1.092|.664|.205
72576549|NCT01120704|144679654|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.09||||0.514|TWO_SIDED|95.0|0.842|1.411|||Regression, Logistic|||The logistic regression model effects consisted of five treatment main effects and all treatment interactions. The main effects provide direct tests of the primary aim of the study, i.e., determining whether or not more intensive treatments (compared to less intensive treatments; e.g., No Automated Adherence Prompting Phone Calls vs. Automated Adherence Prompting Phone Calls) would result in significantly higher abstinence at 52 weeks after target quit day.||1.411|.842|.514
72576550|NCT03485365|144679663|OTHER|Bayesian Repeated Measures Model|Median Difference (Net)|-1.18|STANDARD_DEVIATION|0.494|||TWO_SIDED|95.0|-2.15|-0.2|||||Posterior median difference (GSK3858279 - Placebo) and 95% credible interval is presented.|||-0.20|-2.15|
72576551|NCT03485365|144679664|OTHER|Bayesian Repeated Measures Model|Median Difference (Net)|-1.09|STANDARD_DEVIATION|0.612|||TWO_SIDED|95.0|-2.29|0.12|||||Posterior median difference (GSK3858279 - Placebo) and 95% credible interval is presented.|||0.12|-2.29|
72576552|NCT03332979|144679698|OTHER|Multivariable regression analysis will be used to enable us to explore the impact of modifiable factors reflecting preparation for end of life on the MMCGI-SF.|||||<|0.05|||||||Regression, Linear||||Multivariable regression will be used to explore preparation for end of life on the MMCGI-SF. The analyses will use the MMCGI-SF as the dependent variable with five predictor variables (dementia knowledge \[DKAS\], Social support \[HLQ1\], Communication with healthcare professionals \[HLW4\], advance decisions and knowledge of end of life wishes of person with dementia. There will also be 10 confounders included in the model (gender of caregiver, living arrangement of person with dementia \[at home of a care home\], aged of person with dementia, dementia severity \[CDR\], change in closeness, religiosity \[DURAL\], deprivation and relationship of the carer to the person with dementia).|||<0.05
72576553|NCT05147324|144679706|SUPERIORITY|||||||0.7|||||||t-test, 2 sided|||||||0.70
72576554|NCT05147324|144679707|SUPERIORITY|||||||0.7|||||||t-test, 2 sided|||||||0.70
72576555|NCT05147324|144679715|SUPERIORITY|||||||0.03|||||||t-test, 2 sided|||||||0.03
72576556|NCT01175031|144679755|SUPERIORITY_OR_OTHER|||||||0.003|TWO_SIDED||||||signed-rank tests|||||||0.003
72576557|NCT00555360|144679759|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.74|STANDARD_DEVIATION|2.0||0.975|TWO_SIDED|95.0|-4.62|4.77|||Regression, Logistic|||||4.77|-4.62|.975
72576558|NCT00555360|144679760|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.87|STANDARD_DEVIATION|1.7||0.349|TWO_SIDED|95.0|-5.78|2.05|||Regression, Logistic|||||2.05|-5.78|.349
72576559|NCT00555360|144679761|SUPERIORITY_OR_OTHER||Difference in Percent|14.0|STANDARD_DEVIATION|6.0||0.007|TWO_SIDED|95.0|3.9|24.2|||Regression, Logistic|||||24.2|3.9|.007
72576560|NCT03301623|144679771|SUPERIORITY||Mean Difference (Net)|-0.69||||0.541|TWO_SIDED|95.0|-2.9|1.52|||Mixed Models Analysis|Test is on interaction term between time (pre/post intervention) and treatment group (CDSvsPEAT) dummy variables in the regression model.|The interaction term describes the effect of PEAT in the post period.|"Question: Which communication strategy used during the clinical encounter is more effective in reducing pain interference over time for patients with chronic pain who were taking opioids at baseline?~Regression model includes a fixed effect for time and an interaction effect between pre/post intervention and intervention arm dummy variables. Analysis is clustered at the participant level."||1.52|-2.9|.541
72576561|NCT03301623|144679772|SUPERIORITY||Odds Ratio (OR)|2.96||||0.019|TWO_SIDED|95.0|1.2|7.31|||Regression, Logistic|There were 69 providers with at least one CG-CAHPS response.|The interaction term describes the change in the PEAT group's scores in the post period.|"Question: Which communication strategy used during the clinical encounter is more effective in improving how satisfied patients feel over time after communicating with their physician about chronic pain treatment risks and benefits?~Regression model includes a fixed effect for time and an interaction effect between pre/post intervention and intervention arm dummy variables. Analysis is clustered at the PCP level."||7.31|1.20|.019
72628204|NCT00492557|144784514|NON_INFERIORITY_OR_EQUIVALENCE|The criterion upon which to declare non-inferiority was the lower bound of the 2-sided, 95% CI for the geometric mean ratio greater than 0.5 (2-fold criterion).|Ratio of GMCs|0.66|||||TWO_SIDED|95.0|0.51|0.87|||||CIs for the ratio were back transformations of the CIs based on the Student t distribution for the mean difference of the logarithmically transformed assay results.|Serotype 4. The primary null hypothesis was: the log of the GMC in the group receiving 13vPnC and TIV concomitantly, minus the log of the GMC in the group receiving 13vPnC alone (1 month after TIV) \<= -0.693.||0.87|0.51|
72628205|NCT00492557|144784514|NON_INFERIORITY_OR_EQUIVALENCE|The criterion upon which to declare non-inferiority was the lower bound of the 2-sided, 95% CI for the geometric mean ratio greater than 0.5 (2-fold criterion).|Ratio of GMCs|0.69|||||TWO_SIDED|95.0|0.55|0.86|||||CIs for the ratio were back transformations of the CIs based on the Student t distribution for the mean difference of the logarithmically transformed assay results.|Serotype 5. The primary null hypothesis was: the log of the GMC in the group receiving 13vPnC and TIV concomitantly, minus the log of the GMC in the group receiving 13vPnC alone (1 month after TIV) \<= -0.693.||0.86|0.55|
72628206|NCT00492557|144784514|NON_INFERIORITY_OR_EQUIVALENCE|The criterion upon which to declare non-inferiority was the lower bound of the 2-sided, 95% CI for the geometric mean ratio greater than 0.5 (2-fold criterion).|Ratio of GMCs|0.76|||||TWO_SIDED|95.0|0.61|0.94|||||CIs for the ratio were back transformations of the CIs based on the Student t distribution for the mean difference of the logarithmically transformed assay results.|Serotype 6A. The primary null hypothesis was: the log of the GMC in the group receiving 13vPnC and TIV concomitantly, minus the log of the GMC in the group receiving 13vPnC alone (1 month after TIV) \<= -0.693.||0.94|0.61|
72628207|NCT00492557|144784514|NON_INFERIORITY_OR_EQUIVALENCE|The criterion upon which to declare non-inferiority was the lower bound of the 2-sided, 95% CI for the geometric mean ratio greater than 0.5 (2-fold criterion).|Ratio of GMCs|0.97|||||TWO_SIDED|95.0|0.75|1.25|||||CIs for the ratio were back transformations of the CIs based on the Student t distribution for the mean difference of the logarithmically transformed assay results.|Serotype 6B. The primary null hypothesis was: the log of the GMC in the group receiving 13vPnC and TIV concomitantly, minus the log of the GMC in the group receiving 13vPnC alone (1 month after TIV) \<= -0.693.||1.25|0.75|
72628208|NCT00492557|144784514|NON_INFERIORITY_OR_EQUIVALENCE|The criterion upon which to declare non-inferiority was the lower bound of the 2-sided, 95% CI for the geometric mean ratio greater than 0.5 (2-fold criterion).|Ratio of GMCs|0.84|||||TWO_SIDED|95.0|0.67|1.07|||||CIs for the ratio were back transformations of the CIs based on the Student t distribution for the mean difference of the logarithmically transformed assay results.|Serotype 7F. The primary null hypothesis was: the log of the GMC in the group receiving 13vPnC and TIV concomitantly, minus the log of the GMC in the group receiving 13vPnC alone (1 month after TIV) \<= -0.693.||1.07|0.67|
72576562|NCT03301623|144679773|SUPERIORITY||Mean Difference (Final Values)|-0.42||||0.719|TWO_SIDED|95.0|-2.73|1.88|||Mixed Models Analysis||The interaction term describes the effect of PEAT in the post period.|"Question: Which communication strategy used during the clinical encounter is more effective in improving physical function over time for patients with chronic pain who were taking opioids at baseline?~Regression model includes a fixed effect for time and an interaction effect between pre/post intervention and intervention arm dummy variables. Analysis is clustered at the participant level."||1.88|-2.73|.719
72576563|NCT03301623|144679774|SUPERIORITY||Odds Ratio (OR)|1.63||||0.01|TWO_SIDED|95.0|1.13|2.36|||Mixed Models Analysis||The interaction term describes the effect of PEAT in the post period.|"Question: Which communication strategy used during the clinical encounter is more effective in reducing opioid prescriptions of more than 90 morphine milligrams equivalent (MME) over time for patients with chronic pain who were taking opioids at baseline?~Regression model includes a fixed effect for time and an interaction effect between pre/post intervention and intervention arm dummy variables. Analysis is clustered at the PCP level."||2.36|1.13|.010
72576564|NCT03301623|144679775|SUPERIORITY||Odds Ratio (OR)|0.76||||0.51|TWO_SIDED|95.0|0.34|1.71|||Mixed Models Analysis||The interaction term describes the effect of PEAT in the post period.|Question: Which communication strategy used during the clinical encounter is more effective in reducing co-prescription of opioids and benzodiazepines over time for patients with chronic pain who were taking opioids at baseline?||1.71|.34|.510
72576565|NCT03301623|144679776|SUPERIORITY||Odds Ratio (OR)|1.34||||0.26|TWO_SIDED|95.0|0.76|2.34|||Regression, Logistic|We employed robust standard errors clustered at the participant level. Time was controlled for using a fixed effect.|The interaction term describes the effect of PEAT in the post period.|PHQ-9 was categorized by assigning scores of 0, 1, 2, and 3 to the response categories (not at all: several days, more than half the days, nearly every day, respectively) and then summing. Scores of 5, 10, 15, and 20 represent cutpoints for mild, moderate, moderately severe and severe depression, respectively. The analysis was conducted as a multilevel ordered logistic regression.||2.34|.76|.260
72576566|NCT02092467|144679778|NON_INFERIORITY|Hazard ratio (95% CI) was based on a univariate Cox proportional hazard model with treatment \[All Tofacitinib (ie, tofacitinib 5 mg BID and tofacitinib 10 mg BID combined) and TNFi\] as covariate.|Hazard Ratio (HR)|1.48|||||TWO_SIDED|95.0|1.04|2.09|||||Primary comparison. Non-inferiority was to be claimed between All Tofacitinib and TNFi if the upper limit of the 95% CI for HR was \< 1.8 (non-inferiority criterion).|All Tofacitinib versus TNFi||2.09|1.04|
72576567|NCT02092467|144679778|NON_INFERIORITY|Hazard ratio (95% CI) was based on a univariate cox proportional hazard model with treatment (tofacitinib 5 mg BID, tofacitinib 10 mg BID and TNFi) as covariate.|Hazard Ratio (HR)|1.0|||||TWO_SIDED|95.0|0.7|1.43|||||Secondary comparison. Non-inferiority was to be claimed between tofacitinib 10 mg BID and tofacitinib 5 mg BID if the upper limit of the 95% CI for HR was \< 2.0 (non-inferiority criterion).|Tofacitinib 10 mg BID versus Tofacitinib 5 mg BID||1.43|0.70|
72576568|NCT02092467|144679778|OTHER|Hazard ratio (95% CI) was based on a univariate cox proportional hazard model with treatment (tofacitinib 5 mg BID, tofacitinib 10 mg BID and TNFi) as covariate.|Hazard Ratio (HR)|1.47|||||TWO_SIDED|95.0|1.0|2.18|||||Supportive analysis to the primary comparison between All Tofacitinib vs TNFi.|Tofacitinib 5 mg BID versus TNFi||2.18|1.00|
72628209|NCT00492557|144784514|NON_INFERIORITY_OR_EQUIVALENCE|The criterion upon which to declare non-inferiority was the lower bound of the 2-sided, 95% CI for the geometric mean ratio greater than 0.5 (2-fold criterion).|Ratio of GMCs|0.8|||||TWO_SIDED|95.0|0.63|1.02|||||CIs for the ratio were back transformations of the CIs based on the Student t distribution for the mean difference of the logarithmically transformed assay results.|Serotype 9V. The primary null hypothesis was: the log of the GMC in the group receiving 13vPnC and TIV concomitantly, minus the log of the GMC in the group receiving 13vPnC alone (1 month after TIV) \<= -0.693.||1.02|0.63|
72410225|NCT02710630|144328774|SUPERIORITY_OR_OTHER||Ratio [Test/Reference]|87.26|STANDARD_DEVIATION|60.2|||TWO_SIDED|90.0|69.404|109.722|||||"The adjusted geometric mean (gMean) ratio \[%\] calculated as Dabigatran Etexilate Tablet: B1/Dabigatran Etexilate Capsule: Ref.~Standard deviation is actually intra-individual geometric coefficient of variation (gCV) \[%\]."|||109.722|69.404|
72410226|NCT02710630|144328774|SUPERIORITY_OR_OTHER||Ratio [Test/Reference]|71.4|STANDARD_DEVIATION|49.2|||TWO_SIDED|90.0|58.828|86.648|||||"The adjusted geometric mean (gMean) ratio \[%\] calculated as Dabigatran Etexilate Tablet: C1/Dabigatran Etexilate Capsule: Ref.~Standard deviation is actually intra-individual geometric coefficient of variation (gCV) \[%\]."|||86.648|58.828|
72576569|NCT02092467|144679778|OTHER|Hazard ratio (95% CI) was based on a univariate cox proportional hazard model with treatment (tofacitinib 5 mg BID, tofacitinib 10 mg BID and TNFi) as covariate.|Hazard Ratio (HR)|1.48|||||TWO_SIDED|95.0|1.0|2.19|||||Supportive analysis to the primary comparison between All Tofacitinib vs TNFi.|Tofacitinib 10 mg BID versus TNFi||2.19|1.00|
72576570|NCT02092467|144679779|NON_INFERIORITY|Hazard ratio (95% CI) was based on a univariate Cox proportional hazard model with treatment \[All Tofacitinib (ie, tofacitinib 5 mg BID and tofacitinib 10 mg BID combined) and TNFi\] as covariate.|Hazard Ratio (HR)|1.33|||||TWO_SIDED|95.0|0.91|1.94|||||Primary comparison. Non-inferiority was to be claimed between All Tofacitinib and TNFi if the upper limit of the 95% CI for HR was \< 1.8 (non-inferiority criterion).|All Tofacitinib versus TNFi||1.94|0.91|
72576571|NCT02092467|144679779|NON_INFERIORITY|Hazard ratio (95% CI) was based on a univariate cox proportional hazard model with treatment (tofacitinib 5 mg BID, tofacitinib 10 mg BID and TNFi) as covariate.|Hazard Ratio (HR)|1.15|||||TWO_SIDED|95.0|0.77|1.71|||||Secondary Comparison. Non-inferiority was to be claimed between tofacitinib 10 mg BID and tofacitinib 5 mg BID if the upper limit of the 95% CI for HR was \<2.0 (non-inferiority criterion).|Tofacitinib 10 mg BID versus Tofacitinib 5 mg BID||1.71|0.77|
72576572|NCT02092467|144679779|OTHER|Hazard ratio (95% CI) was based on a univariate cox proportional hazard model with treatment (tofacitinib 5 mg BID, tofacitinib 10 mg BID and TNFi) as covariate.|Hazard Ratio (HR)|1.24|||||TWO_SIDED|95.0|0.81|1.91|||||Supportive analysis to the primary comparison between All Tofacitinib vs TNFi.|Tofacitinib 5 mg BID versus TNFi||1.91|0.81|
72576573|NCT02092467|144679779|OTHER|Hazard ratio (95% CI) was based on a univariate cox proportional hazard model with treatment (tofacitinib 5 mg BID, tofacitinib 10 mg BID and TNFi) as covariate.|Hazard Ratio (HR)|1.43|||||TWO_SIDED|95.0|0.94|2.18|||||Supportive analysis to the primary comparison between All Tofacitinib vs TNFi.|Tofacitinib 10 mg BID versus TNFi||2.18|0.94|
72576574|NCT01595386|144679802|NON_INFERIORITY_OR_EQUIVALENCE|Study sample size was powered to detect a 60% difference in LCOS between groups at α 0.05 and β 0.70, assuming the prevalence of LCOS after neonatal bypass of 65% (based on retrospective data of patients who died, required rescue steroids, ECMO, or epinephrine \> 0.1 μg/kg/min).||||||0.049|TWO_SIDED|||||A p-value of \<0.05 represents the threshold for statistical significance.|t-test, 2 sided|||||||0.049
72576575|NCT01595386|144679803|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation.||||||0.44|TWO_SIDED|95.0|||||Chi-squared|||||||0.44
72576576|NCT01595386|144679804|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation.||||||0.62|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||0.62
72576577|NCT01595386|144679805|NON_INFERIORITY_OR_EQUIVALENCE|There was not a power calculation for this statistic|||||<|0.05|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.05
72576578|NCT01595386|144679805|NON_INFERIORITY_OR_EQUIVALENCE|There was not a power calculation for this statistic|||||<|0.01|TWO_SIDED|95.0||||interleukin-6 at 12, 24, and 48 hour. A p-value of \<0.05 is the threshold for statistical significance.|Wilcoxon (Mann-Whitney)|||||||<0.01
72576579|NCT01595386|144679805|NON_INFERIORITY_OR_EQUIVALENCE|There was not a power calculation for this statistic|||||<|0.01|TWO_SIDED|95.0||||TNF-alpha at 12, 24, and 48 hours.A p-value of \<0.05 is the threshold for statistical significance.|Wilcoxon (Mann-Whitney)|||||||<0.01
72576580|NCT01595386|144679805|NON_INFERIORITY_OR_EQUIVALENCE|There was not a power calculation for this statistic|||||<|0.05|TWO_SIDED|95.0||||Interleukin1-beta at 24 and 48 hours.A p-value of \<0.05 is the threshold for statistical significance.|Wilcoxon (Mann-Whitney)|||||||<0.05
72576581|NCT01595386|144679805|NON_INFERIORITY_OR_EQUIVALENCE|There was not a power calculation for this statistic|||||<|0.05|TWO_SIDED|95.0||||Interleukin-8 at 24 and 48 hours.A p-value of \<0.05 is the threshold for statistical significance.|Wilcoxon (Mann-Whitney)|||||||<0.05
72628210|NCT00492557|144784514|NON_INFERIORITY_OR_EQUIVALENCE|The criterion upon which to declare non-inferiority was the lower bound of the 2-sided, 95% CI for the geometric mean ratio greater than 0.5 (2-fold criterion).|Ratio of GMCs|0.72|||||TWO_SIDED|95.0|0.53|0.97|||||CIs for the ratio were back transformations of the CIs based on the Student t distribution for the mean difference of the logarithmically transformed assay results.|Serotype 14. The primary null hypothesis was: the log of the GMC in the group receiving 13vPnC and TIV concomitantly, minus the log of the GMC in the group receiving 13vPnC alone (1 month after TIV) \<= -0.693.||0.97|0.53|
72628211|NCT00492557|144784514|NON_INFERIORITY_OR_EQUIVALENCE|The criterion upon which to declare non-inferiority was the lower bound of the 2-sided, 95% CI for the geometric mean ratio greater than 0.5 (2-fold criterion).|Ratio of GMCs|0.8|||||TWO_SIDED|95.0|0.64|1.01|||||CIs for the ratio were back transformations of the CIs based on the Student t distribution for the mean difference of the logarithmically transformed assay results.|Serotype 18C. The primary null hypothesis was: the log of the GMC in the group receiving 13vPnC and TIV concomitantly, minus the log of the GMC in the group receiving 13vPnC alone (1 month after TIV) \<= -0.693.||1.01|0.64|
72576582|NCT01595386|144679805|NON_INFERIORITY_OR_EQUIVALENCE|There was not a power calculation for this statistic||||||0.03|TWO_SIDED|95.0||||IL-10 at 4 hours.A p-value of \<0.05 is the threshold for statistical significance.|Wilcoxon (Mann-Whitney)|||||||0.03
72576583|NCT01595386|144679806|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation.|||||<|0.05|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.05
72576584|NCT01595386|144679807|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation.||||||0.04|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||0.04
72576585|NCT01595386|144679808|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation.||||||0.03|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||0.03
72576586|NCT01595386|144679809|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation.||||||0.7|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||0.7
72576587|NCT01595386|144679810|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation.||||||0.76|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||0.76
72576588|NCT01595386|144679811|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation.||||||0.23|TWO_SIDED|95.0|||||Fisher Exact|||||||0.23
72576589|NCT01595386|144679812|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation.|||||<|0.05|TWO_SIDED|95.0|||||Fisher Exact|||||||<0.05
72576590|NCT01595386|144679812|NON_INFERIORITY_OR_EQUIVALENCE|There was not a power calculation for this statistic|||||<|0.001|TWO_SIDED|95.0||||post-operative cortisol.A p-value of \<0.05 is the threshold for statistical significance.|Fisher Exact|||||||<0.001
72576591|NCT01595386|144679812|NON_INFERIORITY_OR_EQUIVALENCE|There was not a power calculation for this statistic||||||0.004|TWO_SIDED|95.0||||Adrenal Insufficiency after bypass.A p-value of \<0.05 is the threshold for statistical significance.|Fisher Exact|||||||0.004
72576592|NCT01595386|144679812|NON_INFERIORITY_OR_EQUIVALENCE|There was not a power calculation for this statistic||||||0.02|TWO_SIDED|95.0||||Development of Low cardiac output syndrome in subjects with Adrenal Insufficiency.A p-value of \<0.05 is the threshold for statistical significance.|Fisher Exact|||||||0.02
72576593|NCT02952898|144679823|SUPERIORITY||||||<|0.0001|||||||Chi-squared, Corrected|||Two-sided, continuity-corrected Chi-square tests was used to evaluate the superiority of GDC 695 gel's complete clearance proportion over that of the Vehicle treatment in the mITT population using LOCF.||||<0.0001
72576594|NCT02952898|144679823|SUPERIORITY||||||<|0.0001|||||||Chi-squared, Corrected|||Two-sided, continuity-corrected Chi-square tests was used to evaluate the superiority of Diclofenac sodium gel's complete clearance proportion over that of the Vehicle treatment in the mITT population using LOCF.||||<0.0001
72576595|NCT04400682|144679843|EQUIVALENCE|0.80-1.25 margins for equivalence|Mean ratio|1.015||||0|TWO_SIDED|90.0|0.9897|1.041|||ANOVA||||Ln(AUClast) : 0.989- 1.0410|1.0410|0.9897|0.0000
72576596|NCT04400682|144679844|EQUIVALENCE|0.80 - 1.25 equivalence margin is required.|Mean ratio|1.0361||||0.0033|TWO_SIDED|90.0|0.9294|1.1551|||ANOVA||||Ln(Cmax) : 0.9294 - 1.1551|1.1551|0.9294|0.0033
72542244|NCT02295280|144614280|SUPERIORITY|||||||0.14||||||Reduction in pain scores by at least 2 units six hours post administration|Mann Whitney U test|Mann Whitney U test used for analysis of this continuous variable as data were not normally distributed. Outcome was comparable at the 6-hour mark.||A sample size calculation of 35 patients in each group was based on an estimated reduction in headache pain score by at least two points, with an a of 0.05 and power of 90%, which is similar to estimates reported in prior studies in non-pregnant patients and felt to be a clinically significant decrease. Statistical analyses were performed using chi-square, Fisher's exact test for categorical variables, the independent Student's t-test and Kolmogorov-Smirnov for continuous variables.||||0.14
72542245|NCT00397839|144614290|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.58|||<|0.001||95.0|1.41|3.76|||ANCOVA|||||3.76|1.41|<0.001
72542246|NCT00397839|144614291|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.86||||0.118||95.0|-0.22|1.94|||ANCOVA|||||1.94|-0.22|0.118
72542247|NCT00397839|144614292|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.13|||<|0.001||95.0|1.34|2.92|||ANCOVA|||Total Hip subgroup||2.92|1.34|<0.001
72542248|NCT00397839|144614292|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.43||||0.012||95.0|0.32|2.55|||ANCOVA|||Femoral Neckm subgroup||2.55|0.32|0.012
72542249|NCT00397839|144614292|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.72||||0.004||95.0|0.56|2.88|||ANCOVA|||Trochanter subgroup||2.88|0.56|0.004
72542250|NCT00397839|144614293|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.75|||<|0.001||95.0|1.11|2.4|||ANCOVA|||Total Hip subgroup||2.40|1.11|<0.001
72542251|NCT00397839|144614293|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.18||||0.031||95.0|0.11|2.25|||ANCOVA|||Femoral Neck subgroup||2.25|0.11|0.031
72542252|NCT00397839|144614293|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.18||||0.031||95.0|0.11|2.25|||ANCOVA|||Trochanter subgroup||2.25|0.11|0.031
72542253|NCT00397839|144614294|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.91||||0.362||95.0|0.73|1.13|||Cochran-Mantel-Haenszel||Relative risk|Total Spine BMD at Month 6||1.13|0.73|0.362
72542254|NCT00397839|144614294|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.85||||0.044||95.0|0.72|1.01|||Cochran-Mantel-Haenszel||Relative risk|Total Spine BMD at Month 12||1.01|0.72|0.044
72542255|NCT00397839|144614294|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.46|||<|0.001||95.0|0.3|0.72|||Cochran-Mantel-Haenszel||Relative risk|Total Hip BMD at Month 6||0.72|0.30|<0.001
72542256|NCT00397839|144614294|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.57|||<|0.001||95.0|0.41|0.8|||Cochran-Mantel-Haenszel||Relative risk|Total Hip BMD at Month 12||0.80|0.41|<0.001
72542257|NCT00397839|144614294|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.41|||<|0.001||95.0|0.23|0.72|||Cochran-Mantel-Haenszel||Relative risk|Both Total Hip and Total Spine BMD at Month 6||0.72|0.23|<0.001
72542258|NCT00397839|144614294|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.5|||<|0.001||95.0|0.33|0.75|||Cochran-Mantel-Haenszel||Relative risk|Both Total Hip and Total Spine BMD||0.75|0.33|<0.001
72542259|NCT01989195|144614326|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||||||<.05
72542260|NCT02731833|144614344|SUPERIORITY_OR_OTHER||Least Square (LS) Mean Difference|-0.4|||<|0.0001|TWO_SIDED|95.0|-0.505|-0.3|||ANCOVA|Change from baseline in Schiff Sensitivity Score as response, treatment as factor and baseline Schiff sensitivity score as a covariate.|Difference is first named dentifrice minus second named dentifrice such that a negative difference favours first named dentifrice.|Statistical analyses was conducted under the null hypothesis (H0) of no difference between treatments versus the alternate hypothesis (H1) of a difference between treatments.||-0.300|-0.505|<0.0001
72542261|NCT01529749|144614433|SUPERIORITY|||||||1|||||||Chi-squared, Corrected|||||||1
72542262|NCT01529749|144614434|SUPERIORITY|||||||1|||||||Chi-squared, Corrected|||||||1
72542263|NCT01529749|144614435|SUPERIORITY|||||||1|||||||Chi-squared, Corrected|||||||1
72542264|NCT01529749|144614436|SUPERIORITY|||||||1|||||||Chi-squared, Corrected|||||||1
72542265|NCT01529749|144614437|SUPERIORITY|||||||1|||||||Chi-squared, Corrected|||||||1
72542266|NCT01529749|144614438|SUPERIORITY|||||||1|||||||Chi-squared, Corrected|||||||1
72542267|NCT01529749|144614439|SUPERIORITY|||||||1|||||||Chi-squared, Corrected|||||||1
72542268|NCT01529749|144614440|SUPERIORITY|||||||1|||||||Chi-squared, Corrected|||||||1
72576597|NCT04400682|144679845|EQUIVALENCE|0.80 - 1.25 equivalence margin is not required.|Mean ratio|1.0108||||0|TWO_SIDED|90.0|0.9856|1.0366|||ANOVA||||Ln(Cmax) : 0.9856 - 1.0366|1.0366|0.9856|0.0000
72576598|NCT02293863|144679849|OTHER||Hazard Ratio (HR)|1.08||||0.605|TWO_SIDED|80.0|0.83|1.4|||Wilcoxon (Mann-Whitney)|||||1.40|0.83|0.6050
72542269|NCT01529749|144614441|SUPERIORITY|||||||0.01|||||||Kruskal-Wallis|||||||0.01
72542270|NCT01529749|144614442|SUPERIORITY|||||||1|||||||Chi-squared, Corrected|||||||1
72542271|NCT01529749|144614443|SUPERIORITY|||||||1|||||||Chi-squared, Corrected|||||||1
72542272|NCT01529749|144614444|SUPERIORITY|||||||1|||||||Chi-squared, Corrected|||||||1
72542273|NCT01529749|144614445|SUPERIORITY|||||||1|||||||Chi-squared, Corrected|||||||1
72542274|NCT01529749|144614446|SUPERIORITY|||||||1|||||||Chi-squared, Corrected|||||||1
72542275|NCT01529749|144614447|SUPERIORITY|||||||1|||||||Chi-squared, Corrected|||||||1
72542276|NCT01529749|144614448|SUPERIORITY|||||||0.49|||||||Chi-squared, Corrected|||||||0.49
72542277|NCT01529749|144614449|SUPERIORITY|||||||0.02|||||||Kruskal-Wallis|||||||0.02
72542278|NCT00265083|144614457|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The positive test is defined if the comparison between combined golimumab and placebo is significant (p-value \<0.05), and at least one of the pair-wise comparisons is also significant (p-value \<0.05).|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel with stratification: screening CRP level (\<=1.5mg/dL, \>1.5mg/dL)||Null hypothesis: No difference in ASAS 20 response comparing Groups I vs II and Groups I vs III. The sample size of 75 patients (pts) in placebo and 135 pts per active group will provide \>=99% power to detect a difference in ASAS 20 response between treatment groups at alpha=0.05, assuming 50% of pts with screening CRP\<1.5mg/dL, and the difference in ASAS 20 response of 10-27.5% in pts with screening CRP\<1.5mg/dL and 32.5-45% in pts with screening CRP\>=1.5mg/dL, between Groups I vs II or III.||||<0.001
72542279|NCT00265083|144614457|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel with stratification: screening CRP level (\<=1.5mg/dL, \>1.5mg/dL)||||||<0.001
72542280|NCT00265083|144614457|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel with stratification: screening CRP level (\<=1.5mg/dL, \>1.5mg/dL)||||||<0.001
72410227|NCT02710630|144328774|SUPERIORITY_OR_OTHER||Ratio [Test/Reference]|116.67|STANDARD_DEVIATION|37.7|||TWO_SIDED|90.0|100.516|135.41|||||"The adjusted geometric mean (gMean) ratio \[%\] calculated as Dabigatran Etexilate Tablet: D1/Dabigatran Etexilate Capsule: Ref.~Standard deviation is actually intra-individual geometric coefficient of variation (gCV) \[%\]."|||135.410|100.516|
72410228|NCT02710630|144328774|SUPERIORITY_OR_OTHER||Ratio [Test/Reference]|109.85|STANDARD_DEVIATION|38.7|||TWO_SIDED|90.0|94.452|127.75|||||"The adjusted geometric mean (gMean) ratio \[%\] calculated as Dabigatran Etexilate Tablet: E1/Dabigatran Etexilate Capsule: Ref.~Standard deviation is actually intra-individual geometric coefficient of variation (gCV) \[%\]."|||127.750|94.452|
72542281|NCT00265083|144614458|SUPERIORITY_OR_OTHER||||||<|0.001||||||The positive test is defined if the comparison between combined golimumab and placebo is significant (p-value \<0.05), and at least one of the pair-wise comparisons is also significant (p-value \<0.05).|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel with stratification: screening CRP level (\<=1.5mg/dL, \>1.5mg/dL)||Null hypothesis: No difference in ASAS 20 response comparing Groups I vs. II and Groups I vs. III.||||<0.001
72542282|NCT00265083|144614458|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel with stratification: screening CRP level (\<=1.5mg/dL, \>1.5mg/dL)||Null hypothesis: no difference in ASAS 20 response between Group II and Group I.||||<0.001
72542283|NCT00265083|144614458|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel with stratification: screening CRP level (\<=1.5mg/dL, \>1.5mg/dL)||Null hypothesis: no difference in ASAS 20 response between Group III and Group I.||||<0.001
72542284|NCT00265083|144614459|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The positive test is defined if the comparison between combined golimumab and placebo is significant (p-value \<0.05), and at least one of the pair-wise comparisons is also significant (p-value \<0.05).|ANOVA on van der Waerden normal scores|ANOVA on van der Waerden normal scores with 2 factors: treatment group and screening C-reactive protein (CRP) level.||Null hypothesis: No difference in change from baseline in BASFI comparing Groups I vs. II and Groups I vs. III.||||<0.001
72542285|NCT00265083|144614459|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA on van der Waerden normal scores|ANOVA on van der Waerden normal scores with 2 factors: treatment group and screening C-reactive protein (CRP) level.||Null hypothesis: no difference in BASFI between Group II and Group I.||||<0.001
72542286|NCT00265083|144614459|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA on van der Waerden normal scores|ANOVA on van der Waerden normal scores with 2 factors: treatment group and screening C-reactive protein (CRP) level.||Null hypothesis: no difference in BASFI between Group III and Group I.||||<0.001
72542287|NCT00265083|144614460|SUPERIORITY_OR_OTHER|||||||0.288||95.0||||The positive test is defined if the comparison between combined golimumab and placebo is significant at the 0.05, and at least one of the pair-wise comparisons is also significant at the 0.05.|ANOVA on van der Waerden normal scores|ANOVA on van der Waerden normal scores with 2 factors: treatment group and screening C-reactive protein (CRP) level.||Null hypothesis: No difference in change from baseline in BASMI comparing Groups I vs. II and Groups I vs. III.||||0.288
72542288|NCT00265083|144614460|SUPERIORITY_OR_OTHER|||||||0.444||95.0|||||ANOVA on van der Waerden normal scores|ANOVA on van der Waerden normal scores with 2 factors: treatment group and screening C-reactive protein (CRP) level.||Null hypothesis: no difference in BASMI between Group II and Group I.||||0.444
72542289|NCT00265083|144614460|SUPERIORITY_OR_OTHER|||||||0.247||95.0|||||ANOVA on van der Waerden normal scores|ANOVA on van der Waerden normal scores with 2 factors: treatment group and screening C-reactive protein (CRP) level.||Null hypothesis: no difference in BASMI between Group III and Group I.||||0.247
72410229|NCT02710630|144328775|SUPERIORITY_OR_OTHER||Ratio [Test/Reference]|115.69|STANDARD_DEVIATION|40.2|||TWO_SIDED|90.0|98.783|135.491|||||"The adjusted geometric mean (gMean) ratio \[%\] calculated as Dabigatran Etexilate Tablet: A1/Dabigatran Etexilate Capsule: Ref.~Standard deviation is actually intra-individual geometric coefficient of variation (gCV) \[%\]."|||135.491|98.783|
72542290|NCT02919475|144614462|SUPERIORITY|||||||0.842|||||||Fisher Exact|||||||0.842
72542291|NCT02919475|144614462|SUPERIORITY|||||||0.841|||||||Fisher Exact|||||||0.841
72542292|NCT02919475|144614462|SUPERIORITY|||||||0.842|||||||Fisher Exact|||||||0.842
72542293|NCT02919475|144614462|SUPERIORITY||||||>|0.999|||||||Fisher Exact|||||||>0.999
72542294|NCT02919475|144614463|SUPERIORITY||||||>|0.999|||||||Fisher Exact|||||||>0.999
72542295|NCT02919475|144614463|SUPERIORITY|||||||0.832|||||||Fisher Exact|||||||0.832
72542296|NCT02919475|144614463|SUPERIORITY|||||||0.682|||||||Fisher Exact|||||||0.682
72542297|NCT02919475|144614463|SUPERIORITY|||||||0.665|||||||Fisher Exact|||||||0.665
72542298|NCT02919475|144614464|SUPERIORITY||||||>|0.999|||||||Fisher Exact|||||||>0.999
72576599|NCT02293863|144679849|OTHER||Hazard Ratio (HR)|1.13||||0.2028|TWO_SIDED|80.0|0.85|1.51|||Wilcoxon (Mann-Whitney)|||||1.51|0.85|0.2028
72576600|NCT02293863|144679851|OTHER||Difference in event rates|10.19||||0.1905|TWO_SIDED|80.0|-0.15|20.52|||Cochran-Mantel-Haenszel|||||20.52|-0.15|0.1905
72576601|NCT02293863|144679851|OTHER||Difference in event rates|7.91||||0.3168|TWO_SIDED|80.0|-2.64|18.47|||Cochran-Mantel-Haenszel|||||18.47|-2.64|0.3168
72576602|NCT02293863|144679852|OTHER||Difference in event rates|-7.92||||0.6043|TWO_SIDED|80.0|-27.5|11.66|||Cochran-Mantel-Haenszel|||||11.66|-27.50|0.6043
72576603|NCT02293863|144679852|OTHER||Difference in event rates|-14.58||||0.3865|TWO_SIDED|80.0|-36.13|6.97|||Cochran-Mantel-Haenszel|||||6.97|-36.13|0.3865
72628212|NCT00492557|144784514|NON_INFERIORITY_OR_EQUIVALENCE|The criterion upon which to declare non-inferiority was the lower bound of the 2-sided, 95% CI for the geometric mean ratio greater than 0.5 (2-fold criterion).|Ratio of GMCs|0.7|||||TWO_SIDED|95.0|0.56|0.87|||||CIs for the ratio were back transformations of the CIs based on the Student t distribution for the mean difference of the logarithmically transformed assay results.|Serotype 19A. The primary null hypothesis was: the log of the GMC in the group receiving 13vPnC and TIV concomitantly, minus the log of the GMC in the group receiving 13vPnC alone (1 month after TIV) \<= -0.693.||0.87|0.56|
72542299|NCT02919475|144614464|SUPERIORITY|||||||0.627|||||||Fisher Exact|||||||0.627
72542300|NCT02919475|144614464|SUPERIORITY|||||||0.794|||||||Fisher Exact|||||||0.794
72542301|NCT02919475|144614464|SUPERIORITY|||||||0.453|||||||Fisher Exact|||||||0.453
72542302|NCT02919475|144614465|SUPERIORITY|||||||0.113|||||||Fisher Exact|||||||0.113
72542303|NCT02919475|144614465|SUPERIORITY|||||||0.024|||||||Fisher Exact|||||||0.024
72542304|NCT02919475|144614465|SUPERIORITY|||||||0.056|||||||Fisher Exact|||||||0.056
72542305|NCT02919475|144614465|SUPERIORITY|||||||0.035|||||||Fisher Exact|||||||0.035
72542306|NCT01928446|144614472|SUPERIORITY||Cox Proportional Hazard|1.1||||0.61|TWO_SIDED|95.0|0.77|1.55|||Log Rank|||Model1 - Treatment only: unadjusted for other covariates||1.55|0.77|0.61
72542307|NCT01928446|144614472|SUPERIORITY||Cox Proportional Hazard|1.08||||0.67|TWO_SIDED|95.0|0.76|1.53|||Log Rank|||Model2 - Treatment only: unadjusted with Site as random Effect||1.53|0.76|0.67
72542308|NCT01928446|144614473|SUPERIORITY||Cox Proportional Hazard|1.49||||0.37|TWO_SIDED|95.0|0.61|3.64|||Log Rank|||||3.64|0.61|0.37
72542309|NCT01928446|144614474|SUPERIORITY||Cox Proportional Hazard|1.14||||0.77|TWO_SIDED|95.0|0.48|2.69|||Log Rank|||Model 5: Non-fatal self-directed violence subgroup||2.69|0.48|0.77
72542310|NCT01928446|144614474|SUPERIORITY||Cox Proportional Hazard|1.61||||0.22|TWO_SIDED|95.0|0.75|3.43|||Log Rank|||Model 6: Interrupted self-directed violence subgroup||3.43|0.75|0.22
72542311|NCT01928446|144614474|SUPERIORITY||Cox Proportional Hazard|0.92||||0.71|TWO_SIDED|95.0|0.58|1.45|||Log Rank|||Model 7: Hospitalization to prevent suicide||1.45|0.58|0.71
72542312|NCT00775983|144614481|NON_INFERIORITY_OR_EQUIVALENCE|Power: We assumed a standard deviation of five minutes based on historical clinic data for surgical abortions during this gestational duration range, a non-inferiority margin of five minutes, and a 10% potential attrition rate to power the study for a non-inferiority hypothesis. Thirty participants in each arm gave us 95% power to conclude non-inferiority of same day Dilapan-S compared to overnight laminaria with respect to procedure time of surgical abortions between 14-18 weeks gestation.|Mean Difference (Final Values)|2.1|||||TWO_SIDED|97.5|-0.3|4.5|||t-test, 2 sided|||Null Hypothesis: A surgical abortion performed between 14-18 weeks gestation performed after the cervix has been prepared with same-day Dilapan-S is inferior with respect to procedure time, which is specifically outside a five minute margin of non-inferiority, when compared to procedures during the same gestational duration range performed after the cervix has been prepared overnight with laminaria.||4.5|-0.3|
72542313|NCT00623623|144614491|OTHER||Relative risk|0.86||||0.195|TWO_SIDED|95.0|0.68|1.08|||modified Poisson regression model|modified Poisson regression model with robust error variance||No confirmatory statistical hypothesis was pre-specified. All statistical tests were of exploratory nature based on descriptive p-values for formal statistical hypotheses generation.||1.08|0.68|0.195
72542314|NCT00623623|144614492|OTHER||Relative risk|1.03||||0.904|TWO_SIDED|95.0|0.68|1.55|||modified Poisson regression|modified Poisson regression model with robust error variance||No confirmatory statistical hypothesis was pre-specified. All statistical tests were of exploratory nature based on descriptive p-values for formal statistical hypotheses generation.||1.55|0.68|0.904
72576604|NCT02293863|144679853|OTHER||Difference in event rates|1.99||||0.5379|TWO_SIDED|80.0|-5.57|9.56|||Cochran-Mantel-Haenszel|||Day 14||9.56|-5.57|0.5379
72576605|NCT02293863|144679853|OTHER||Difference in event rates|4.97||||0.2189|TWO_SIDED|80.0|-3.12|13.05|||Cochran-Mantel-Haenszel|||Day 14||13.05|-3.12|0.2189
72576606|NCT02293863|144679853|OTHER||Difference in event rates|2.14||||0.6594|TWO_SIDED|80.0|-6.04|10.31|||Cochran-Mantel-Haenszel|||Day 30||10.31|-6.04|0.6594
72576607|NCT02293863|144679853|OTHER||Difference in event rates|3.54||||0.5013|TWO_SIDED|80.0|-5.24|12.31|||Cochran-Mantel-Haenszel|||Day 30||12.31|-5.24|0.5013
72576608|NCT02293863|144679853|OTHER||Difference in event rates|2.21||||0.6849|TWO_SIDED|80.0|-6.28|10.69|||Cochran-Mantel-Haenszel|||Day 60||10.69|-6.28|0.6849
72576609|NCT02293863|144679853|OTHER||Difference in event rates|1.68||||0.7633|TWO_SIDED|80.0|-7.38|10.74|||Cochran-Mantel-Haenszel|||Day 60||10.74|-7.38|0.7633
72576610|NCT02293863|144679854|OTHER||Mean Difference (Final Values)|-3.73||||0.2407|TWO_SIDED|80.0|-6.41|-1.06|||ANOVA|||||-1.06|-6.41|0.2407
72576611|NCT02293863|144679854|OTHER||Mean Difference (Final Values)|-0.7||||0.8339|TWO_SIDED|80.0|-3.49|2.1|||ANOVA|||||2.10|-3.49|0.8339
72542315|NCT00623623|144614493|OTHER||Relative risk|0.97||||0.905|TWO_SIDED|95.0|0.6|1.58|||modified Poisson regression model|modified Poisson regression model with robust error variance||No confirmatory statistical hypothesis was pre-specified. All statistical tests were of exploratory nature based on descriptive p-values for formal statistical hypotheses generation.||1.58|0.60|0.905
72542316|NCT00623623|144614494|SUPERIORITY_OR_OTHER||Relative risk|0.73||||0.12|TWO_SIDED|95.0|0.49|1.08|||modified Poisson regression model|modified Poisson regression model with robust error variance||No confirmatory statistical hypothesis was pre-specified. All statistical tests were of exploratory nature based on descriptive p-values for formal statistical hypotheses generation.||1.08|0.49|0.120
72542317|NCT00623623|144614495|OTHER||Relative risk|0.79||||0.17|TWO_SIDED|95.0|0.57|1.11|||modified Poisson regression model|modified Poisson regression model with robust error variance||No confirmatory statistical hypothesis was pre-specified. All statistical tests were of exploratory nature based on descriptive p-values for formal statistical hypotheses generation.||1.11|0.57|0.170
72542318|NCT00623623|144614496|OTHER||Relative risk|1.1||||0.758|TWO_SIDED|95.0|0.61|1.97|||modified Poisson regression model|modified Poisson regression model with robust error variance||No confirmatory statistical hypothesis was pre-specified. All statistical tests were of exploratory nature based on descriptive p-values for formal statistical hypotheses generation.||1.97|0.61|0.758
72542319|NCT00623623|144614497|OTHER||Relative risk|1.1||||0.663|TWO_SIDED|95.0|0.73|1.66|||modified Poisson regression model|modified Poisson regression model with robust error variance||No confirmatory statistical hypothesis was pre-specified. All statistical tests were of exploratory nature based on descriptive p-values for formal statistical hypotheses generation.||1.66|0.73|0.663
72542320|NCT00623623|144614498|OTHER||Relative risk|1.72||||0.148|TWO_SIDED|95.0|0.82|3.6|||modified Poisson regression model|modified Poisson regression model with robust error variance||No confirmatory statistical hypothesis was pre-specified. All statistical tests were of exploratory nature based on descriptive p-values for formal statistical hypotheses generation.||3.60|0.82|0.148
72542321|NCT00623623|144614499|OTHER||Relative risk|0.5||||0.572|TWO_SIDED|95.0|0.05|5.52|||modified Poisson regression model|modified Poisson regression model with robust error variance||No confirmatory statistical hypothesis was pre-specified. All statistical tests were of exploratory nature based on descriptive p-values for formal statistical hypotheses generation.||5.52|0.05|0.572
72542322|NCT00623623|144614500|OTHER||Relative risk|0.81||||0.207|TWO_SIDED|95.0|0.58|1.13|||modified Poission Regression model|modified Poisson regression model with robust error variance||No confirmatory statistical hypothesis was pre-specified. All statistical tests were of exploratory nature based on descriptive p-values for formal statistical hypotheses generation.||1.13|0.58|0.207
72542323|NCT00623623|144614501|OTHER||Relative risk|0.81||||0.1|TWO_SIDED|95.0|0.63|1.04|||modified Poission Regression model|modified Poisson regression model with robust error variance||No confirmatory statistical hypothesis was pre-specified. All statistical tests were of exploratory nature based on descriptive p-values for formal statistical hypotheses generation.||1.04|0.63|0.100
72542324|NCT00623623|144614502|OTHER||Relative Risk|0.91||||0.511|TWO_SIDED|95.0|0.67|1.22|||modified Poission Regression model|modified Poisson regression model with robust error variance||No confirmatory statistical hypothesis was pre-specified. All statistical tests were of exploratory nature based on descriptive p-values for formal statistical hypotheses generation.||1.22|0.67|0.511
72542325|NCT00623623|144614503|OTHER||Relative Risk|1.75||||0.369|TWO_SIDED|95.0|0.52|5.97|||modified Poisson regression model|modified Poisson regression model with robust error variance||No confirmatory statistical hypothesis was pre-specified. All statistical tests were of exploratory nature based on descriptive p-values for formal statistical hypotheses generation.||5.97|0.52|0.369
72542326|NCT00623623|144614504|OTHER||Relative Risk|4.99||||0.168|TWO_SIDED|95.0|0.51|49.08|||modified Poisson regression model|modified Poisson regression model with robust error variance||No confirmatory statistical hypothesis was pre-specified. All statistical tests were of exploratory nature based on descriptive p-values for formal statistical hypotheses generation.||49.08|0.51|0.168
72542327|NCT00623623|144614505|OTHER||Relative Risk|8.02||||0.049|TWO_SIDED|95.0|1.0|63.97|||modified Poisson regression model|modified Poisson regression model with robust error variance||No confirmatory statistical hypothesis was pre-specified. All statistical tests were of exploratory nature based on descriptive p-values for formal statistical hypotheses generation.||63.97|1.00|0.049
72542328|NCT00623623|144614506|OTHER||Relative Risk|4.51||||0.054|TWO_SIDED|95.0|0.98|20.82|||modified Poisson regression model|modified Poisson regression model with robust error variance||No confirmatory statistical hypothesis was pre-specified. All statistical tests were of exploratory nature based on descriptive p-values for formal statistical hypotheses generation.||20.82|0.98|0.054
72542329|NCT00623623|144614507|OTHER||Relative Risk|2.0||||0.324|TWO_SIDED|95.0|0.5|7.99|||modified Poisson regression model|modified Poisson regression model with robust error variance||No confirmatory statistical hypothesis was pre-specified. All statistical tests were of exploratory nature based on descriptive p-values for formal statistical hypotheses generation.||7.99|0.50|0.324
72542330|NCT00623623|144614508|OTHER||Relative Risk|3.01||||0.032|TWO_SIDED|95.0|1.1|8.24|||modified Poisson regression model|modified Poisson regression model with robust error variance||No confirmatory statistical hypothesis was pre-specified. All statistical tests were of exploratory nature based on descriptive p-values for formal statistical hypotheses generation.||8.24|1.10|0.032
72542331|NCT00623623|144614509|OTHER||Relative Risk|1.36||||0.111|TWO_SIDED|95.0|0.93|1.97|||modified Poisson regression model|modified Poisson regression model with robust error variance||No confirmatory statistical hypothesis was pre-specified. All statistical tests were of exploratory nature based on descriptive p-values for formal statistical hypotheses generation.||1.97|0.93|0.111
72542332|NCT00623623|144614510|OTHER||Relative Risk|1.08||||0.397|TWO_SIDED|95.0|0.91|1.28|||modified Poisson regression model|modified Poisson regression model with robust error variance||No confirmatory statistical hypothesis was pre-specified. All statistical tests were of exploratory nature based on descriptive p-values for formal statistical hypotheses generation.||1.28|0.91|0.397
72576612|NCT02293863|144679855|OTHER||Mean Difference (Final Values)|-0.33||||0.279|TWO_SIDED|80.0|-0.6|-0.07|||ANOVA|||||-0.07|-0.60|0.2790
72576613|NCT02293863|144679855|OTHER||Mean Difference (Final Values)|-0.42||||0.1909|TWO_SIDED|80.0|-0.7|-0.15|||ANOVA|||||-0.15|-0.70|0.1909
72576614|NCT02293863|144679856|OTHER||Hazard Ratio (HR)|1.01||||0.7413|TWO_SIDED|80.0|0.77|1.32|||Wilcoxon (Mann-Whitney)|||||1.32|0.77|0.7413
72576615|NCT02293863|144679856|OTHER||Hazard Ratio (HR)|1.32||||0.4763|TWO_SIDED|80.0|0.99|1.77|||Wilcoxon (Mann-Whitney)|||||1.77|0.99|0.4763
72542333|NCT00623623|144614511|OTHER||Relative Risk|1.13||||0.107|TWO_SIDED|95.0|0.97|1.31|||modified Poisson regression model|modified Poisson regression model with robust error variance||No confirmatory statistical hypothesis was pre-specified. All statistical tests were of exploratory nature based on descriptive p-values for formal statistical hypotheses generation.||1.31|0.97|0.107
72542334|NCT00623623|144614512|OTHER||Relative Risk|0.84||||0.471|TWO_SIDED|95.0|0.53|1.34|||modified Poisson regression model|modified Poisson regression model with robust error variance||No confirmatory statistical hypothesis was pre-specified. All statistical tests were of exploratory nature based on descriptive p-values for formal statistical hypotheses generation.||1.34|0.53|0.471
72542335|NCT00623623|144614513|SUPERIORITY||Relative Risk|0.35||||0.003|TWO_SIDED|95.0|0.17|0.71|||modified Poisson regression model|modified Poisson regression model with robust error variance||No confirmatory statistical hypothesis was pre-specified. All statistical tests were of exploratory nature based on descriptive p-values for formal statistical hypotheses generation.||0.71|0.17|0.003
72542336|NCT00623623|144614514|OTHER||Relative risk|1.17||||0.451|TWO_SIDED|95.0|0.78|1.73|||modified Poisson regression model|modified Poisson regression model with robust error variance||||1.73|0.78|0.451
72542337|NCT00623623|144614515|OTHER||Relative Risk|0.87||||0.22|TWO_SIDED|95.0|0.69|1.09|||modified Poisson regression model|modified Poisson regression model with robust error variance||||1.09|0.69|0.220
72542338|NCT02499354|144614516|SUPERIORITY|||||||0.2742|||||||t-test, 1 sided|||||||0.2742
72542339|NCT02499354|144614517|SUPERIORITY|||||||0.55|||||||Chi-squared|||||||0.55
72542340|NCT01427920|144614527|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for subject-driven vs. investigator driven titration would be concluded if the upper bound of the two-sided 95% CI was below or equal to 0.4%.|Estimated treatment difference, Mean|0.25||||||95.0|0.04|0.46|||Regression, Linear|Model includes treatment, strata and region as factors and relevant baseline HbA1c as covariate.||FAS||0.46|0.04|
72542341|NCT01427920|144614528|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for subject-driven vs. investigator driven titration would be concluded if the upper bound of the two-sided 95% CI was below or equal to 0.4%.|Estimated treatment difference, Mean|0.26||||||95.0|0.05|0.48|||Regression, Linear|Model includes treatment, strata and region as factors and relevant baseline HbA1c as covariate.||PP||0.48|0.05|
72542342|NCT01427920|144614529|SUPERIORITY_OR_OTHER||Estimated treatment difference, Mean|0.13||||0.659||95.0|-0.44|0.69|||Regression, Linear|Model includes treatment, strata and region as factors and relevant baseline FPG as covariate.||H0: D = 0.0% against HA: D ≠ 0.0%, where D is the mean treatment difference (subject-driven titration minus investigator-driven titration).||0.69|-0.44|0.659
72410230|NCT02710630|144328775|SUPERIORITY_OR_OTHER||Ratio [Test/Reference]|50.43|STANDARD_DEVIATION|173.7|||TWO_SIDED|90.0|31.519|80.689|||||"The adjusted geometric mean (gMean) ratio \[%\] calculated as Dabigatran Etexilate Tablet: B1/Dabigatran Etexilate Capsule: Ref.~Standard deviation is actually intra-individual geometric coefficient of variation (gCV) \[%\]."|||80.689|31.519|
72542343|NCT01202994|144614542|OTHER||correlation coefficient|-0.45|||<|0.05|TWO_SIDED|||||This is a calculated p-value.|correlation|||The primary analysis is to examine the correlation between the practice effect z-score (presented in the Secondary Outcome section) and the standardized uptake value of flutemetamol (presented in the Outcome module).||||<0.05
72542344|NCT00837577|144614572|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.92|STANDARD_ERROR_OF_MEAN|0.09|<|0.001|TWO_SIDED|95.0|-1.09|-0.75||Adjusted for other prior antihyperglycemic medications (absence, presence).|Longitudinal data analysis (LDA)|LDA model included both baseline and post-baseline measurements as response variables. P-value calculated using least squares mean.||||-0.75|-1.09|<.001
72542345|NCT00837577|144614573|SUPERIORITY_OR_OTHER||Least squares mean difference|-51.3|STANDARD_ERROR_OF_MEAN|5.6|<|0.001|TWO_SIDED|95.0|-62.3|-40.2||Adjusted for other prior antihyperglycemic medications (absence, presence).|Longitudinal data analysis (LDA)|LDA model included both baseline and post-baseline measurements as response variables. P-value calculated using least squares mean.||||-40.2|-62.3|<.001
72576616|NCT02293863|144679857|OTHER||Hazard Ratio (HR)|1.01||||0.8806|TWO_SIDED|80.0|0.78|1.32|||Wilcoxon (Mann-Whitney)|||||1.32|0.78|0.8806
72576617|NCT02293863|144679857|OTHER||Hazard Ratio (HR)|1.05||||0.5447|TWO_SIDED|80.0|0.8|1.38|||Wilcoxon (Mann-Whitney)|||||1.38|0.80|0.5447
72576618|NCT02293863|144679858|OTHER||Hazard Ratio (HR)|0.7||||0.4171|TWO_SIDED|80.0|0.47|1.03|||Wilcoxon (Mann-Whitney)|||||1.03|0.47|0.4171
72542346|NCT00837577|144614574|SUPERIORITY_OR_OTHER||Least squares mean difference|-22.5|STANDARD_ERROR_OF_MEAN|3.8|<|0.001|TWO_SIDED|95.0|-30.0|-15.0||Adjusted for other prior antihyperglycemic medications (absence, presence).|Longitudinal data analysis (LDA)|LDA model included both baseline and post-baseline measurements as response variables. P-value calculated using least squares mean.||||-15.0|-30.0|<.001
72542347|NCT00919802|144614575|OTHER|||||||0.688|||||||t-test, 2 sided|||Global Response Assessment (GRA) scores were obtained 6 and 24 hours post oxytocin or saline administration.||||0.688
72576619|NCT02293863|144679858|OTHER||Hazard Ratio (HR)|0.9||||0.8322|TWO_SIDED|80.0|0.61|1.34|||Wilcoxon (Mann-Whitney)|||||1.34|0.61|0.8322
72576620|NCT02293863|144679859|OTHER||Difference in event rates|-1.42||||0.824|TWO_SIDED|80.0|-10.61|7.76|||Cochran-Mantel-Haenszel|||||7.76|-10.61|0.8240
72542348|NCT00919802|144614576|OTHER|paired t-test comparison of change in VAR from baseline 6 hours after drug; a change in VAR score was calculated for each subject for each arm and compared using a paired t-test||||||0.7252|||||||t-test, 2 sided|||||||0.7252
72542349|NCT01205529|144614582|SUPERIORITY||Odds Ratio (OR)|0.0||||1|TWO_SIDED||||||Regression, Logistic||0 participants with rare SCN5A non-synonymous variants met the primary outcome for ST-segment elevation.||Given the very small number of outcomes (N=4) and the small number of participants with the primary determinant (N=2), a Fisher's Exact Test is the appropriate test and it yields a P-value=1.000.|||1.0
72542350|NCT02059187|144614595|NON_INFERIORITY_OR_EQUIVALENCE|MK-1293 was to be considered non-inferior to Lantus in type 2 diabetes mellitus (T2DM) if the upper bound of the two-sided 95% confidence interval (CI) for the between-treatment difference (MK-1293 minus Lantus) in least-squares (LS) means was below 0.4% based on a cLDA model.|Difference in least squares means|0.03|||||TWO_SIDED|95.0|-0.12|0.18||||||||0.18|-0.12|
72542351|NCT02059187|144614596|SUPERIORITY_OR_OTHER||Difference in percentage|5.7|||||TWO_SIDED|95.0|-2.3|13.7||||||||13.7|-2.3|
72542352|NCT02059187|144614598|SUPERIORITY_OR_OTHER||Difference in percentage|0.0|||||TWO_SIDED|95.0|-8.5|8.5||||||||8.5|-8.5|
72542353|NCT02059187|144614599|SUPERIORITY_OR_OTHER||Difference in percent|6.8|||||TWO_SIDED|95.0|-0.6|14.2||||||||14.2|-0.6|
72542354|NCT02059187|144614600|SUPERIORITY_OR_OTHER||Difference in LS means|1.4|||||TWO_SIDED|95.0|-2.2|4.9||||||||4.9|-2.2|
72542355|NCT02059187|144614601|SUPERIORITY_OR_OTHER||Dofference in LS means|0.01|||||TWO_SIDED|95.0|-0.02|0.05||||||||0.05|-0.02|
72542356|NCT02059187|144614602|SUPERIORITY_OR_OTHER||Difference in LS means|3.5|||||TWO_SIDED|95.0|-3.7|10.7||||||||10.7|-3.7|
72542357|NCT02059187|144614603|SUPERIORITY_OR_OTHER||Difference in LS Means|-3.4|||||TWO_SIDED|95.0|-11.3|4.4||||||||4.4|-11.3|
72542358|NCT02059187|144614604|SUPERIORITY_OR_OTHER||Adjusted difference in percent|2.8|||||TWO_SIDED|95.0|-6.1|11.6|||||Calculated via Miettinen and Nurminen method, stratified by prior insulin status.|||11.6|-6.1|
72542359|NCT02059187|144614605|SUPERIORITY_OR_OTHER||Adjusted difference in percent|-0.9|||||TWO_SIDED|95.0|-8.3|6.5|||||Calculated via Miettinen and Nurminen method, stratified by prior insulin status.|||6.5|-8.3|
72542360|NCT03070431|144614606|SUPERIORITY|It was assumed that radiotherapy with 5x4 Gy results in 6-month LPFS of 67% and an increase by 20% is clinically relevant when using 5x5 Gy. For comparison of 5x5 Gy and a historical control (5x4 Gy), it was assumed that it can be performed with a simple Pearson-Chi-Square test (2-sided significance level of 5%, power of 79%) if 40 patients treated with 5x5 Gy and 400 patients of the control group qualified for Propensity-Score adjusted comparison, assuming 6-month LPFS rates of 87% and 67%.|Risk Difference (RD)|20.0|||<|0.05|TWO_SIDED||||||Cochran-Mantel-Haenszel|||historical control group treated with 5 x 4 Gy|"In a prospective study, 6-month LPFS rates were 86% after longer-course (mainly 3Gyx10) and 67% after short-course radiotherapy (mainly 4Gyx5) \[Rades D, et al., Int J Radiat Oncol Biol Phys 2009;73:228-34.\]. For sample size calculations, it was assumed that conventional radiotherapy with 4Gyx5 results in 6-month LPFS of 67% and that an increase by 20% is clinically relevant and realistic with 5Gyx5. A sample size of 40 eligible patients was required for the phase 2 trial assuming that that 6-month LPFS would be 87% and estimated with a precision of +/-20% expressed as the half length of the associated two-sided confidence interval (95%), and power of \>=80%.~For comparison of phase 2 cohort and historical control group, it was assumed that this could be performed with a simple Pearson-Chi-Square test using a two-sided significance level of 5% (10%) and a power of 79% (86%) if 40 patients received 5Gyx5 and N=400 of the control group qualified for Propensity-Score adjusted comparison."|||<0.05
72542361|NCT01889862|144614616|SUPERIORITY||Mean Difference (Net)|-973.02|||<|0.0001|TWO_SIDED|95.0|-1204.19|-741.85||Based on Mixed-Effect Model Repeated Measure (MMRM) model with change from baseline as the response variable, and treatment, visit and treatment by visit interaction and baseline blood phe concentration as factors.|ANCOVA|||Change in blood Phe concentration during Part 2 in subjects previously exposed to BMN165 who self administer BMN165 20mg/day compared with those who self administer matching placebo.||-741.85|-1204.19|<0.0001
72542362|NCT01889862|144614616|SUPERIORITY||Mean Difference (Net)|-588.5|||<|0.0001|TWO_SIDED|95.0|-830.07|-346.94||Based on Mixed-Effect Model Repeated Measure (MMRM) model with change from baseline as the response variable, and treatment, visit and treatment by visit interaction and baseline blood phe concentration as factors.|ANCOVA|||Change in blood Phe concentration during Part 2 in subjects previously exposed to BMN165 who self administer BMN165 40mg/day compared with those who self administer matching placebo.||-346.94|-830.07|<0.0001
72542363|NCT02065791|144614622|SUPERIORITY||Hazard Ratio (HR)|0.7|||<|0.0001|TWO_SIDED|95.0|0.59|0.82|||Cox Proportional Hazard|||Comparison for canagliflozin versus placebo is reported here.||0.82|0.59|< 0.0001
72542364|NCT02065791|144614623|SUPERIORITY||Hazard Ratio (HR)|0.69|||=|0.0001|TWO_SIDED|95.0|0.57|0.83|||Cox proportional hazard|||Comparison for canagliflozin versus placebo is reported here.||0.83|0.57|=0.0001
72542365|NCT02065791|144614624|SUPERIORITY||Hazard Ratio (HR)|0.8|||=|0.0121|TWO_SIDED|95.0|0.67|0.95|||Cox proportional hazard|||Comparison for canagliflozin versus placebo is reported here.||0.95|0.67|=0.0121
72542366|NCT02065791|144614625|SUPERIORITY||Hazard Ratio (HR)|0.61|||=|0.0003|TWO_SIDED|95.0|0.47|0.8|||Cox proportional hazards|||Comparison for canagliflozin versus placebo is reported here.||0.80|0.47|=0.0003
72542367|NCT02065791|144614626|SUPERIORITY||Hazard Ratio (HR)|0.66|||<|0.0001|TWO_SIDED|95.0|0.53|0.81|||Cox proportional hazards|||Comparison for canagliflozin versus placebo is reported here.||0.81|0.53|<0.0001
72542368|NCT02065791|144614627|SUPERIORITY||Hazard Ratio (HR)|0.78|||=|0.0502|TWO_SIDED|95.0|0.61|1.0|||Cox proportional hazards|||Comparison for canagliflozin versus placebo is reported here.||1.00|0.61|=0.0502
72542369|NCT02065791|144614628|SUPERIORITY||Hazard Ratio (HR)|0.83|||=|0.0727|TWO_SIDED|95.0|0.68|1.02|||Cox proportional hazard|||Comparison for canagliflozin versus placebo is reported here.||1.02|0.68|= 0.0727
72542370|NCT02065791|144614629|SUPERIORITY||Hazard Ratio (HR)|0.74||||0.0001|TWO_SIDED|95.0|0.63|0.86|||Cox proportional hazards|||Comparison for canagliflozin versus placebo is reported here.||0.86|0.63|0.0001
72576621|NCT02293863|144679859|OTHER||Difference in event rates|-1.6||||0.8111|TWO_SIDED|80.0|-11.48|8.28|||Cochran-Mantel-Haenszel|||||8.28|-11.48|0.8111
72576622|NCT02293863|144679860|OTHER||Difference in event rates|2.42||||0.7219|TWO_SIDED|80.0|-6.96|11.8|||Cochran-Mantel-Haenszel|||||11.80|-6.96|0.7219
72542371|NCT00272961|144614630|SUPERIORITY_OR_OTHER||Least Squares (LS) Mean Difference|8.37|STANDARD_ERROR_OF_MEAN|6.19||0.185|TWO_SIDED|95.0|-4.21|20.96|||ANCOVA|||Sitting SBP: p-value was obtained using an Analysis of Co-variance (ANCOVA) model on the maximum increase observed with baseline value as a covariate.||20.96|-4.21|0.185
72410231|NCT02710630|144328775|SUPERIORITY_OR_OTHER||Ratio [Test/Reference]|56.71|STANDARD_DEVIATION|74.2|||TWO_SIDED|90.0|43.388|74.122|||||"The adjusted geometric mean (gMean) ratio \[%\] calculated as Dabigatran Etexilate Tablet: C1/Dabigatran Etexilate Capsule: Ref.~Standard deviation is actually intra-individual geometric coefficient of variation (gCV) \[%\]."|||74.122|43.388|
72542372|NCT00272961|144614630|SUPERIORITY_OR_OTHER||LS Mean Difference|0.21|STANDARD_ERROR_OF_MEAN|5.59||0.97|TWO_SIDED|95.0|-11.16|11.59|||ANCOVA|||Sitting SBP: p-value was obtained using an ANCOVA model on the maximum increase observed with baseline value as a covariate.||11.59|-11.16|0.970
72542373|NCT00272961|144614630|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|5.71||0.994|TWO_SIDED|95.0|-11.66|11.57|||ANCOVA|||Sitting SBP: p-value was obtained using an ANCOVA model on the maximum increase observed with baseline value as a covariate.||11.57|-11.66|0.994
72542374|NCT00272961|144614630|SUPERIORITY_OR_OTHER||LS Mean Difference|1.01|STANDARD_ERROR_OF_MEAN|5.72||0.861|TWO_SIDED|95.0|-10.62|12.64|||ANCOVA|||Sitting SBP: p-value was obtained using an ANCOVA model on the maximum increase observed with baseline value as a covariate.||12.64|-10.62|0.861
72542375|NCT00272961|144614630|SUPERIORITY_OR_OTHER||LS Mean Difference|6.1|STANDARD_ERROR_OF_MEAN|4.9||0.221|TWO_SIDED|95.0|-3.79|15.99|||ANCOVA|||Standing SBP: p-value was obtained using an ANCOVA model on the maximum increase observed with baseline value as a covariate.||15.99|-3.79|0.221
72542376|NCT00272961|144614630|SUPERIORITY_OR_OTHER||LS Mean Difference|0.68|STANDARD_ERROR_OF_MEAN|4.49||0.88|TWO_SIDED|95.0|-8.37|9.73|||ANCOVA|||Standing SBP: p-value was obtained using an ANCOVA model on the maximum increase observed with baseline value as a covariate.||9.73|-8.37|0.880
72542377|NCT00272961|144614630|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.57|STANDARD_ERROR_OF_MEAN|4.56||0.9|TWO_SIDED|95.0|-9.78|8.63|||ANCOVA|||Standing SBP: p-value was obtained using an ANCOVA model on the maximum increase observed with baseline value as a covariate.||8.63|-9.78|0.900
72542378|NCT00272961|144614630|SUPERIORITY_OR_OTHER||LS Mean Difference|-5.71|STANDARD_ERROR_OF_MEAN|4.56||0.218|TWO_SIDED|95.0|-14.91|3.5|||ANCOVA|||Standing SBP: p-value was obtained using an ANCOVA model on the maximum increase observed with baseline value as a covariate.||3.50|-14.91|0.218
72576623|NCT02293863|144679860|OTHER||Difference in event rates|0.67||||0.9225|TWO_SIDED|80.0|-9.29|10.64|||Cochran-Mantel-Haenszel|||||10.64|-9.29|0.9225
72576624|NCT02293863|144679861|OTHER||Difference in event rates|1.99||||0.5379|TWO_SIDED|80.0|-5.57|9.56|||Cochran-Mantel-Haenszel|||||9.56|-5.57|0.5379
72576625|NCT02293863|144679861|OTHER||Difference in event rates|-1.85||||0.3667|TWO_SIDED|80.0|-9.88|6.18|||Cochran-Mantel-Haenszel|||||6.18|-9.88|0.3667
72576626|NCT02293863|144679862|OTHER||Hazard Ratio (HR)|0.66||||0.7827|TWO_SIDED|80.0|0.41|1.07|||Wilcoxon (Mann-Whitney)|||||1.07|0.41|0.7827
72576627|NCT02293863|144679862|OTHER||Hazard Ratio (HR)|0.58||||0.2522|TWO_SIDED|80.0|0.36|0.96|||Wilcoxon (Mann-Whitney)|||||0.96|0.36|0.2522
72576628|NCT04123561|144679874|SUPERIORITY|"The primary efficacy endpoint is defined as the change from Injection 1 Baseline in WOMAC Pain on a normalized scale of 0-4 at Week 12 between the randomized TLC599 12mg and Placebo groups.~The least-squares mean, alongside its corresponding 95% confidence interval, was used to estimate the treatment difference between TLC599 and Placebo, utilizing two-sided p-values."|Least Squares Mean Difference (LSMD)|-0.171|STANDARD_ERROR_OF_MEAN|0.0819||0.0372|TWO_SIDED|95.0|-0.331|-0.01|||ANCOVA|Parameters estimated via REML using the Newton-Raphson algorithm, and the Kenward-Roger method calculates denominator degrees of freedom.||||-0.010|-0.331|0.0372
72576629|NCT03462459|144679976|EQUIVALENCE|Proportional tests (Chi-squared) compared the episodes of C. difficile. Log-rank tests (Kaplan-Meier) were conducted to compare the non-recurrence proportions within the eight-week period. Multivariate Cox proportional hazard regression determined if treatment, age, and number of previous C. difficile episodes were predictors of recurrence.|See comments|-0.11||||0.22|TWO_SIDED|95.0|-35.1|8.0|||Chi-squared||Proportional tests compared episodes of C. difficile recurrence in eight weeks (vancomycin vs. placebo) using Chi-squared test. Log-rank tests compared the non-recurrence proportions within 8 weeks with the Kaplan-Meier method.||"Statistical analyses are primarily reported for the population who were randomized in the study (as randomized). The secondary statistical analyses are reported for the population who completed all three visits (as completed treatment). Proportional tests were conducted to compare the episodes of C. difficile recurrence in eight weeks following the completion of the study intervention in patients receiving vancomycin versus placebo using the Chi-squared test. Log-rank tests were conducted to compare the non-recurrence proportions within the eight-week period in patients receiving vancomycin versus placebo with the Kaplan-Meier method. A nonparametric Wilcoxon rank sum test was used to compare distributions of the number of days to the first recurrence of CDI after starting oral vancomycin or placebo. The significance level was set to be ≤0.05. All statistical analyses were conducted in R statistical software (version 4.4.0; R Core Team, 2024)"|8.0|-35.1|0.22
72576630|NCT03462459|144679978|EQUIVALENCE|Proportional difference tests comparing the proportion of patients with VRE colonization at Visit 3, compared to baseline. Significance level was set to 0.10.||||||0.1|||||||Proportional difference test|||||||0.10
72576631|NCT03452137|144680052|SUPERIORITY||Hazard Ratio (HR)|0.94||||0.6804|TWO_SIDED|95.0|0.7|1.26|||Log Rank||HR was estimated by Cox regression.|Stratified Analysis: The stratification factors were response to definitive local therapy, human papillomavirus (HPV) status and type of definitive local therapy as per interactive voice or web-based response system (IxRS).||1.26|0.70|0.6804
72576632|NCT03452137|144680053|SUPERIORITY||Hazard Ratio (HR)|0.96||||0.8371|TWO_SIDED|95.0|0.68|1.36|||Log Rank||HR was estimated by Cox regression.|Stratified Analysis: The stratification factors were response to definitive local therapy, HPV status and type of definitive local therapy as per interactive voice or web-based response system (IxRS).||1.36|0.68|0.8371
72576633|NCT03452137|144680054|SUPERIORITY||Hazard Ratio (HR)|0.98||||0.9115|TWO_SIDED|95.0|0.73|1.32|||Log Rank||HR was estimated by Cox regression|Stratified Analysis: The stratification factors were response to definitive local therapy, HPV status and type of definitive local therapy as per interactive voice or web-based response system (IxRS).||1.32|0.73|0.9115
72576634|NCT03452137|144680055|SUPERIORITY||Difference in Event Free Rate|-0.67||||0.8816|TWO_SIDED|95.0|-9.45|8.11|||Z test|||Difference in EFS Event-Free Rates at 1 year||8.11|-9.45|0.8816
72410232|NCT02710630|144328775|SUPERIORITY_OR_OTHER||Ratio [Test/Reference]|106.99|STANDARD_DEVIATION|52.8|||TWO_SIDED|90.0|87.554|130.732|||||"The adjusted geometric mean (gMean) ratio \[%\] calculated as Dabigatran Etexilate Tablet: D1/Dabigatran Etexilate Capsule: Ref.~Standard deviation is actually intra-individual geometric coefficient of variation (gCV) \[%\]."|||130.732|87.554|
72542379|NCT00272961|144614630|SUPERIORITY_OR_OTHER||LS Mean Difference|5.62|STANDARD_ERROR_OF_MEAN|2.68||0.044|TWO_SIDED|95.0|0.17|11.08|||ANCOVA|||Sitting DBP: p-value was obtained using an ANCOVA model on the maximum increase observed with baseline value as a covariate.||11.08|0.17|0.044
72542380|NCT00272961|144614630|SUPERIORITY_OR_OTHER||LS Mean Difference|1.43|STANDARD_ERROR_OF_MEAN|2.41||0.557|TWO_SIDED|95.0|-3.47|6.33|||ANCOVA|||Sitting DBP: p-value was obtained using an ANCOVA model on the maximum increase observed with baseline value as a covariate.||6.33|-3.47|0.557
72542381|NCT00272961|144614630|SUPERIORITY_OR_OTHER||LS Mean Difference|6.37|STANDARD_ERROR_OF_MEAN|2.5||0.016|TWO_SIDED|95.0|1.28|11.45|||ANCOVA|||Sitting DBP: p-value was obtained using an ANCOVA model on the maximum increase observed with baseline value as a covariate.||11.45|1.28|0.016
72542382|NCT00272961|144614630|SUPERIORITY_OR_OTHER||LS Mean Difference|0.99|STANDARD_ERROR_OF_MEAN|2.5||0.695|TWO_SIDED|95.0|-4.09|6.07|||ANCOVA|||Sitting DBP: p-value was obtained using an ANCOVA model on the maximum increase observed with baseline value as a covariate.||6.07|-4.09|0.695
72542383|NCT00272961|144614630|SUPERIORITY_OR_OTHER||LS Mean Difference|4.8|STANDARD_ERROR_OF_MEAN|2.56||0.067|TWO_SIDED|95.0|-0.36|9.95|||ANCOVA|||Standing DBP: p-value was obtained using an ANCOVA model on the maximum increase observed with baseline value as a covariate.||9.95|-0.36|0.067
72542384|NCT00272961|144614630|SUPERIORITY_OR_OTHER||LS Mean Difference|0.8|STANDARD_ERROR_OF_MEAN|2.36||0.737|TWO_SIDED|95.0|-3.96|5.55|||ANCOVA|||Standing DBP: p-value was obtained using an ANCOVA model on the maximum increase observed with baseline value as a covariate.||5.55|-3.96|0.737
72542385|NCT00272961|144614630|SUPERIORITY_OR_OTHER||LS Mean Difference|5.64|STANDARD_ERROR_OF_MEAN|2.4||0.023|TWO_SIDED|95.0|0.8|10.47|||ANCOVA|||Standing DBP: p-value was obtained using an ANCOVA model on the maximum increase observed with baseline value as a covariate.||10.47|0.80|0.023
72542386|NCT00272961|144614630|SUPERIORITY_OR_OTHER||LS Mean Difference|1.65|STANDARD_ERROR_OF_MEAN|2.4||0.495|TWO_SIDED|95.0|-3.2|6.5|||ANCOVA|||Standing DBP: p-value was obtained using an ANCOVA model on the maximum increase observed with baseline value as a covariate.||6.50|-3.20|0.495
72542387|NCT00272961|144614631|SUPERIORITY_OR_OTHER||LS Mean Difference|232.59|STANDARD_ERROR_OF_MEAN|201.83||0.2577|TWO_SIDED|95.0|-178.5|643.7|||ANCOVA|||Sitting SBP: p-value was obtained using an ANCOVA model on AUEC calculated over treatment and follow-up phases with baseline value as a covariate.||643.7|-178.5|0.2577
72542388|NCT00272961|144614631|SUPERIORITY_OR_OTHER||LS Mean Difference|103.67|STANDARD_ERROR_OF_MEAN|173.86||0.5552|TWO_SIDED|95.0|-250.5|457.8|||ANCOVA|||Sitting SBP: p-value was obtained using an ANCOVA model on AUEC calculated over treatment and follow-up phases with baseline value as a covariate.||457.8|-250.5|0.5552
72542389|NCT00272961|144614631|SUPERIORITY_OR_OTHER||LS Mean Difference|41.26|STANDARD_ERROR_OF_MEAN|177.26||0.8174|TWO_SIDED|95.0|-319.8|402.3|||ANCOVA|||Sitting SBP: p-value was obtained using an ANCOVA model on AUEC calculated over treatment and follow-up phases with baseline value as a covariate.||402.3|-319.8|0.8174
72542390|NCT00272961|144614631|SUPERIORITY_OR_OTHER||LS Mean Difference|166.4|STANDARD_ERROR_OF_MEAN|177.55||0.3557|TWO_SIDED|95.0|-195.3|528.1|||ANCOVA|||Sitting SBP: p-value was obtained using an ANCOVA model on AUEC calculated over treatment and follow-up phases with baseline value as a covariate.||528.1|-195.3|0.3557
72542391|NCT00272961|144614631|SUPERIORITY_OR_OTHER||LS Mean Difference|163.04|STANDARD_ERROR_OF_MEAN|130.15||0.2172|TWO_SIDED|95.0|-99.6|425.7|||ANCOVA|||Standing SBP: p-value was obtained using an ANCOVA model on AUEC calculated over treatment and follow-up phases with baseline value as a covariate.||425.7|-99.6|0.2172
72542392|NCT00272961|144614631|SUPERIORITY_OR_OTHER||LS Mean Difference|115.35|STANDARD_ERROR_OF_MEAN|116.03||0.3258|TWO_SIDED|95.0|-118.8|349.5|||ANCOVA|||Standing SBP: p-value was obtained using an ANCOVA model on AUEC calculated over treatment and follow-up phases with baseline value as a covariate.||349.5|-118.8|0.3258
72542393|NCT00272961|144614631|SUPERIORITY_OR_OTHER||LS Mean Difference|24.67|STANDARD_ERROR_OF_MEAN|117.88||0.8352|TWO_SIDED|95.0|-213.2|262.6|||ANCOVA|||Standing SBP: p-value was obtained using an ANCOVA model on AUEC calculated over treatment and follow-up phases with baseline value as a covariate.||262.6|-213.2|0.8352
72542394|NCT00272961|144614631|SUPERIORITY_OR_OTHER||LS Mean Difference|50.59|STANDARD_ERROR_OF_MEAN|117.93||0.6701|TWO_SIDED|95.0|-187.4|288.6|||ANCOVA|||Standing SBP: p-value was obtained using an ANCOVA model on AUEC calculated over treatment and follow-up phases with baseline value as a covariate.||288.6|-187.4|0.6701
72576635|NCT03452137|144680055|SUPERIORITY||Difference in Event Free Rate|0.46||||0.9234|TWO_SIDED|95.0|-8.86|9.78|||Z test|||Difference in EFS Event-Free Rates at 2 years||9.78|-8.86|0.9234
72576636|NCT03452137|144680055|SUPERIORITY||Difference in Event Free Rate|1.19||||0.809|TWO_SIDED|95.0|-8.49|10.88|||Z test|||Difference in EFS Event-Free Rates at 3 years||10.88|-8.49|0.8090
72576637|NCT03452137|144680055|SUPERIORITY||Difference in Event Free Rate|0.01||||0.9985|TWO_SIDED|95.0|-10.17|10.19|||Z test|||Difference in EFS Event-Free Rates at 4 years||10.19|-10.17|0.9985
72576638|NCT03452137|144680056|SUPERIORITY||Difference in Event Free Rate|5.17||||0.2393|TWO_SIDED|95.0|-3.44|13.79|||Z test|||Difference in EFS Event-Free Rates at 1 year||13.79|-3.44|0.2393
72576639|NCT03452137|144680056|SUPERIORITY||Difference in Event Free Rate|3.61||||0.4472|TWO_SIDED|95.0|-5.69|12.9|||Z test|||Difference in EFS Event-Free Rates at 2 years||12.90|-5.69|0.4472
72576640|NCT03452137|144680056|SUPERIORITY||Difference in Event Free Rate|3.14||||0.5222|TWO_SIDED|95.0|-6.49|12.77|||Z test|||Difference in EFS Event-Free Rates at 3 years||12.77|-6.49|0.5222
72576641|NCT03452137|144680056|SUPERIORITY||Difference in Event Free Rate|1.31||||0.7967|TWO_SIDED|95.0|-8.64|11.26|||Z test|||Difference in EFS Event-Free Rates at 4 years||11.26|-8.64|0.7967
72410233|NCT02710630|144328775|SUPERIORITY_OR_OTHER||Ratio [Test/Reference]|107.07|STANDARD_DEVIATION|40.7|||TWO_SIDED|90.0|91.399|125.432|||||"The adjusted geometric mean (gMean) ratio \[%\] calculated as Dabigatran Etexilate Tablet: E1/Dabigatran Etexilate Capsule: Ref.~Standard deviation is actually intra-individual geometric coefficient of variation (gCV) \[%\]."|||125.432|91.399|
72410234|NCT02710630|144328776|SUPERIORITY_OR_OTHER||Ratio [Test/Reference]|115.39|STANDARD_DEVIATION|45.3|||TWO_SIDED|90.0|96.74|137.644|||||"The adjusted geometric mean (gMean) ratio \[%\] calculated as Dabigatran Etexilate Tablet: A1/Dabigatran Etexilate Capsule: Ref.~Standard deviation is actually intra-individual geometric coefficient of variation (gCV) \[%\]."|||137.644|96.740|
72410235|NCT02710630|144328776|SUPERIORITY_OR_OTHER||Ratio [Test/Reference]|54.12|STANDARD_DEVIATION|138.6|||TWO_SIDED|90.0|35.818|81.774|||||"The adjusted geometric mean (gMean) ratio \[%\] calculated as Dabigatran Etexilate Tablet: B1/Dabigatran Etexilate Capsule: Ref.~Standard deviation is actually intra-individual geometric coefficient of variation (gCV) \[%\]."|||81.774|35.818|
72410236|NCT02710630|144328776|SUPERIORITY_OR_OTHER||Ratio [Test/Reference]|58.96|STANDARD_DEVIATION|71.4|||TWO_SIDED|90.0|45.489|76.431|||||"The adjusted geometric mean (gMean) ratio \[%\] calculated as Dabigatran Etexilate Tablet: C1/Dabigatran Etexilate Capsule: Ref.~Standard deviation is actually intra-individual geometric coefficient of variation (gCV) \[%\]."|||76.431|45.489|
72410237|NCT02710630|144328776|SUPERIORITY_OR_OTHER||Ratio [Test/Reference]|106.38|STANDARD_DEVIATION|57.0|||TWO_SIDED|90.0|85.846|131.836|||||"The adjusted geometric mean (gMean) ratio \[%\] calculated as Dabigatran Etexilate Tablet: D1/Dabigatran Etexilate Capsule: Ref.~Standard deviation is actually intra-individual geometric coefficient of variation (gCV) \[%\]."|||131.836|85.846|
72576642|NCT03452137|144680057|SUPERIORITY||Difference in Event Free Rate|2.77||||0.4819|TWO_SIDED|95.0|-4.95|10.49|||Z test|||Difference in OS Event-Free Rates at 2 years||10.49|-4.95|0.4819
72576643|NCT03452137|144680057|SUPERIORITY||Difference in Event Free Rate|-1.25||||0.7783|TWO_SIDED|95.0|-9.97|7.47|||Z test|||Difference in OS Event-Free Rates at 3 years||7.47|-9.97|0.7783
72576644|NCT03452137|144680057|SUPERIORITY||Difference in Event Free Rate|-1.07||||0.8924|TWO_SIDED|95.0|-16.56|14.42|||Z test|||Difference in OS Event-Free Rates at 5 years||14.42|-16.56|0.8924
72410238|NCT02710630|144328776|SUPERIORITY_OR_OTHER||Ratio [Test/Reference]|103.73|STANDARD_DEVIATION|43.3|||TWO_SIDED|90.0|87.74|122.628|||||"The adjusted geometric mean (gMean) ratio \[%\] calculated as Dabigatran Etexilate Tablet: E1/Dabigatran Etexilate Capsule: Ref.~Standard deviation is actually intra-individual geometric coefficient of variation (gCV) \[%\]."|||122.628|87.740|
72410239|NCT02710630|144328777|SUPERIORITY_OR_OTHER||Ratio [Test/Reference]|115.27|STANDARD_DEVIATION|38.4|||TWO_SIDED|90.0|99.063|134.13|||||"The adjusted geometric mean (gMean) ratio \[%\] calculated as Dabigatran Etexilate Tablet: A1/Dabigatran Etexilate Capsule: Ref.~Standard deviation is actually intra-individual geometric coefficient of variation (gCV) \[%\]."|||134.130|99.063|
72410240|NCT02710630|144328777|SUPERIORITY_OR_OTHER||Ratio [Test/Reference]|83.73|STANDARD_DEVIATION|62.8|||TWO_SIDED|90.0|66.033|106.163|||||"The adjusted geometric mean (gMean) ratio \[%\] calculated as Dabigatran Etexilate Tablet: B1/Dabigatran Etexilate Capsule: Ref.~Standard deviation is actually intra-individual geometric coefficient of variation (gCV) \[%\]."|||106.163|66.033|
72410241|NCT02710630|144328777|SUPERIORITY_OR_OTHER||Ratio [Test/Reference]|68.77|STANDARD_DEVIATION|50.3|||TWO_SIDED|90.0|56.452|83.782|||||"The adjusted geometric mean (gMean) ratio \[%\] calculated as Dabigatran Etexilate Tablet: C1/Dabigatran Etexilate Capsule: Ref.~Standard deviation is actually intra-individual geometric coefficient of variation (gCV) \[%\]."|||83.782|56.452|
72576645|NCT02089659|144680063|OTHER||Geometric Mean Ratio|0.99|||||TWO_SIDED|90.0|0.72|1.35|||||Moderate hepatic insufficiency / Healthy controls|||1.35|0.72|
72576646|NCT02089659|144680064|OTHER||Geometric Mean Ratio|0.9|||||TWO_SIDED|90.0|0.66|1.24|||||Moderate hepatic insufficiency / Healthy controls|||1.24|0.66|
72576647|NCT02089659|144680065|OTHER||Geometric Mean Ratio|0.93|||||TWO_SIDED|90.0|0.74|1.18|||||Moderate hepatic insufficiency / Healthy controls|||1.18|0.74|
72576648|NCT02089659|144680066|OTHER||Geometric Mean Ratio|0.99|||||TWO_SIDED|90.0|0.74|1.33|||||Moderate hepatic insufficiency / Healthy controls|||1.33|0.74|
72576649|NCT02657928|144680071|SUPERIORITY|||||||0.5004|||||||Log Rank|||||||0.5004
72576650|NCT02657928|144680072|SUPERIORITY|||||||0.9127|||||||Log Rank|||||||0.9127
72576651|NCT01564537|144680088|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.742||||0.012|TWO_SIDED|95.0|0.587|0.939|||Log Rank||HR is estimated from Cox Regression.|||0.939|0.587|0.012
72369110|NCT00478023|144248219|SUPERIORITY_OR_OTHER_LEGACY||Least square mean difference|20.6|||<|0.0001||95.0|13.4|27.8||No multiplicity adjustment used.|ANCOVA|ANCOVA with treatment and centre as fixed effects and baseline pain as covariate.|Only pain intensity assessments collected prior to the first dose of any additional analgesic medication considered. Afterwards LOCF used.|Null hypothesis of no treatment difference.||27.8|13.4|<0.0001
72542395|NCT00272961|144614631|SUPERIORITY_OR_OTHER||LS Mean Difference|225.57|STANDARD_ERROR_OF_MEAN|108.95||0.0466|TWO_SIDED|95.0|3.6|447.5|||ANCOVA|||Sitting DBP: p-value was obtained using an ANCOVA model on AUEC calculated over treatment and follow-up phases with baseline value as a covariate.||447.5|3.6|0.0466
72542396|NCT00272961|144614631|SUPERIORITY_OR_OTHER||LS Mean Difference|114.77|STANDARD_ERROR_OF_MEAN|93.2637||0.2274|TWO_SIDED|95.0|-75.2|304.8|||ANCOVA|||Sitting DBP: p-value was obtained using an ANCOVA model on AUEC calculated over treatment and follow-up phases with baseline value as a covariate.||304.8|-75.2|0.2274
72628213|NCT00492557|144784514|NON_INFERIORITY_OR_EQUIVALENCE|The criterion upon which to declare non-inferiority was the lower bound of the 2-sided, 95% CI for the geometric mean ratio greater than 0.5 (2-fold criterion).|Ratio of GMCs|0.65|||||TWO_SIDED|95.0|0.49|0.85|||||CIs for the ratio were back transformations of the CIs based on the Student t distribution for the mean difference of the logarithmically transformed assay results.|Serotype 19F. The primary null hypothesis was: the log of the GMC in the group receiving 13vPnC and TIV concomitantly, minus the log of the GMC in the group receiving 13vPnC alone (1 month after TIV) \<= -0.693.||0.85|0.49|
72628214|NCT00492557|144784514|NON_INFERIORITY_OR_EQUIVALENCE|The criterion upon which to declare non-inferiority was the lower bound of the 2-sided, 95% CI for the geometric mean ratio greater than 0.5 (2-fold criterion).|Ratio of GMCs|0.95|||||TWO_SIDED|95.0|0.71|1.27|||||CIs for the ratio were back transformations of the CIs based on the Student t distribution for the mean difference of the logarithmically transformed assay results.|Serotype 23F. The primary null hypothesis was: the log of the GMC in the group receiving 13vPnC and TIV concomitantly, minus the log of the GMC in the group receiving 13vPnC alone (1 month after TIV) \<= -0.693.||1.27|0.71|
72628215|NCT00492557|144784517|NON_INFERIORITY_OR_EQUIVALENCE|The criterion upon which to declare non-inferiority was if the lower limit of the 2-sided 95%CI for the GMT ratios, (13vPnC+TIV relative to 13vPnC administered 1 month after TIV+placebo) was greater than 0.5 (2-fold criterion).|GMT Ratio|0.9|||||TWO_SIDED|95.0|0.68|1.24|||||2-sided 95% CIs for the GMT ratio were calculated by back transformations of the 95% CIs based on the Student t distribution for the mean difference of the logarithmically transformed assay results.|Serotype 1. The primary null hypothesis was: the log of the GMT in the group receiving 13vPnC + TIV minus the log of the GMT in the group receiving 13vPnC alone (1 month after TIV) \<= -0.693.||1.24|0.68|
72542397|NCT00272961|144614631|SUPERIORITY_OR_OTHER||LS Mean Difference|224.89|STANDARD_ERROR_OF_MEAN|96.9259||0.0269|TWO_SIDED|95.0|27.5|422.3|||ANCOVA|||Sitting DBP: p-value was obtained using an ANCOVA model on AUEC calculated over treatment and follow-up phases with baseline value as a covariate.||422.3|27.5|0.0269
72542398|NCT00272961|144614631|SUPERIORITY_OR_OTHER||LS Mean Difference|133.22|STANDARD_ERROR_OF_MEAN|96.7383||0.178|TWO_SIDED|95.0|-63.8|330.3|||ANCOVA|||Sitting DBP: p-value was obtained using an ANCOVA model on AUEC calculated over treatment and follow-up phases with baseline value as a covariate.||330.3|-63.8|0.1780
72542399|NCT00272961|144614631|SUPERIORITY_OR_OTHER||LS Mean Difference|240.64|STANDARD_ERROR_OF_MEAN|114.32||0.0413|TWO_SIDED|95.0|9.9|471.4|||ANCOVA|||Standing DBP: p-value was obtained using an ANCOVA model on AUEC calculated over treatment and follow-up phases with baseline value as a covariate.||471.4|9.9|0.0413
72542400|NCT00272961|144614631|SUPERIORITY_OR_OTHER||LS Mean Difference|157.99|STANDARD_ERROR_OF_MEAN|102.21||0.1297|TWO_SIDED|95.0|-48.3|364.3|||ANCOVA|||Standing DBP: p-value was obtained using an ANCOVA model on AUEC calculated over treatment and follow-up phases with baseline value as a covariate.||364.3|-48.3|0.1297
72542401|NCT00272961|144614631|SUPERIORITY_OR_OTHER||LS Mean Difference|254.9|STANDARD_ERROR_OF_MEAN|104.0||0.0185|TWO_SIDED|95.0|45.0|464.8|||ANCOVA|||Standing DBP: p-value was obtained using an ANCOVA model on AUEC calculated over treatment and follow-up phases with baseline value as a covariate.||464.8|45.0|0.0185
72542402|NCT00272961|144614631|SUPERIORITY_OR_OTHER||LS Mean Difference|157.66|STANDARD_ERROR_OF_MEAN|104.33||0.1382|TWO_SIDED|95.0|-52.9|368.2|||ANCOVA|||Standing DBP: p-value was obtained using an ANCOVA model on AUEC calculated over treatment and follow-up phases with baseline value as a covariate.||368.2|-52.9|0.1382
72542403|NCT00272961|144614636|SUPERIORITY_OR_OTHER||LS Mean Difference|0.86|STANDARD_ERROR_OF_MEAN|3.0||0.7758|TWO_SIDED|95.0|-5.31|7.03|||ANCOVA|||Pre-Dose on Week 10: p-value was obtained using an ANCOVA model on the sitting-standing difference at Week 10 (Pre-Dose) with the sitting-standing difference at Baseline as a covariate.||7.03|-5.31|0.7758
72542404|NCT00272961|144614636|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.35|STANDARD_ERROR_OF_MEAN|2.45||0.888|TWO_SIDED|95.0|-5.4|4.71|||ANCOVA|||Pre-Dose on Week 10: p-value was obtained using an ANCOVA model on the sitting-standing difference at Week 10 (Pre-Dose) with the sitting-standing difference at Baseline as a covariate.||4.71|-5.40|0.8880
72542405|NCT00272961|144614636|SUPERIORITY_OR_OTHER||LS Mean Difference|1.86|STANDARD_ERROR_OF_MEAN|2.46||0.4573|TWO_SIDED|95.0|-3.21|6.93|||ANCOVA|||Pre-Dose on Week 10: p-value was obtained using an ANCOVA model on the sitting-standing difference at Week 10 (Pre-Dose) with the sitting-standing difference at Baseline as a covariate.||6.93|-3.21|0.4573
72542406|NCT00272961|144614636|SUPERIORITY_OR_OTHER||LS Mean Difference|2.17|STANDARD_ERROR_OF_MEAN|2.78||0.4424|TWO_SIDED|95.0|-3.56|7.91|||ANCOVA|||Pre-Dose on Week 10: p-value was obtained using an ANCOVA model on the sitting-standing difference at Week 10 (Pre-Dose) with the sitting-standing difference at Baseline as a covariate.||7.91|-3.56|0.4424
72542407|NCT00272961|144614636|SUPERIORITY_OR_OTHER||LS Mean Difference|3.18|STANDARD_ERROR_OF_MEAN|3.32||0.347|TWO_SIDED|95.0|-3.65|10.01|||ANCOVA|||Post-Dose on Week 10: p-value was obtained using an ANCOVA model on the sitting-standing difference at Week 10 (Post-Dose) with the sitting-standing difference at Baseline as a covariate.||10.01|-3.65|0.3470
72542408|NCT00272961|144614636|SUPERIORITY_OR_OTHER||LS Mean Difference|1.34|STANDARD_ERROR_OF_MEAN|2.72||0.6249|TWO_SIDED|95.0|-4.25|6.94|||ANCOVA|||Post-Dose on Week 10: p-value was obtained using an ANCOVA model on the sitting-standing difference at Week 10 (Post-Dose) with the sitting-standing difference at Baseline as a covariate.||6.94|-4.25|0.6249
72410242|NCT02710630|144328777|SUPERIORITY_OR_OTHER||Ratio [Test/Reference]|107.13|STANDARD_DEVIATION|49.6|||TWO_SIDED|90.0|88.616|129.51|||||"The adjusted geometric mean (gMean) ratio \[%\] calculated as Dabigatran Etexilate Tablet: D1/Dabigatran Etexilate Capsule: Ref.~Standard deviation is actually intra-individual geometric coefficient of variation (gCV) \[%\]."|||129.510|88.616|
72410243|NCT02710630|144328777|SUPERIORITY_OR_OTHER||Ratio [Test/Reference]|106.64|STANDARD_DEVIATION|38.9|||TWO_SIDED|90.0|91.625|124.114|||||"The adjusted geometric mean (gMean) ratio \[%\] calculated as Dabigatran Etexilate Tablet: E1/Dabigatran Etexilate Capsule: Ref.~Standard deviation is actually intra-individual geometric coefficient of variation (gCV) \[%\]."|||124.114|91.625|
72410244|NCT03224468|144328799|SUPERIORITY|Power was determined to be 85.2% using a Monte Carlo simulation approach in which data were simulated from a multi-level linear regression model with a subject-varying random intercept, a shared baseline across WLC and MMC, and fixed effects for a change over each time point. Simulated data were fit with a linear model estimated via GEE - simulations were repeated 1000 times and power was estimated as the proportion where the contrast between WLC and MM had p\<0.05.|Mean Difference (Net)|0.28|STANDARD_ERROR_OF_MEAN|0.06|<|0.001|TWO_SIDED|95.0|0.15|0.4||The p-value is adjusted for multiple comparisons using per Benjamini \& Hochberg (1995) across the five primary outcome measures. Effects were deemed significant for p\<0.05.|Regression, Linear|Estimates were obtained using generalized estimating equations (GEE) with robust standard errors obtained by the sandwich estimator.|Estimate is the mean difference in number of symptoms for MM above and beyond WLC (positive values denote higher number of symptoms for MM).|The mean difference in number of symptoms between the MM and WLC groups was estimated via a linear model with a dummy-coded contrast (0 for WLC, 1 for MM). The model adjusted for change at weeks 4 and 12 of the study, and for a subject's number of symptoms at baseline.||0.40|0.15|<0.001
72542409|NCT00272961|144614636|SUPERIORITY_OR_OTHER||LS Mean Difference|3.92|STANDARD_ERROR_OF_MEAN|2.73||0.1625|TWO_SIDED|95.0|-1.69|9.54|||ANCOVA|||Post-Dose on Week 10: p-value was obtained using an ANCOVA model on the sitting-standing difference at Week 10 (Post-Dose) with the sitting-standing difference at Baseline as a covariate.||9.54|-1.69|0.1625
72542410|NCT00272961|144614636|SUPERIORITY_OR_OTHER||LS Mean Difference|0.97|STANDARD_ERROR_OF_MEAN|3.08||0.7556|TWO_SIDED|95.0|-5.38|7.31|||ANCOVA|||Post-Dose on Week 10: p-value was obtained using an ANCOVA model on the sitting-standing difference at Week 10 (Post-Dose) with the sitting-standing difference at Baseline as a covariate.||7.31|-5.38|0.7556
72542411|NCT00272961|144614637|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.99|STANDARD_ERROR_OF_MEAN|1.59||0.0714|TWO_SIDED|95.0|-6.25|0.28|||ANCOVA|||Pre-Dose on Week 10: p-value was obtained using an ANCOVA model on the sitting-standing difference at Week 10 (Pre-Dose) with the sitting-standing difference at Baseline as a covariate.||0.28|-6.25|0.0714
72542412|NCT00272961|144614637|SUPERIORITY_OR_OTHER||LS Mean Difference|0.47|STANDARD_ERROR_OF_MEAN|1.34||0.7269|TWO_SIDED|95.0|-2.29|3.24|||ANCOVA|||Pre-Dose on Week 10: p-value was obtained using an ANCOVA model on the sitting-standing difference at Week 10 (Pre-Dose) with the sitting-standing difference at Baseline as a covariate.||3.24|-2.29|0.7269
72542413|NCT00272961|144614637|SUPERIORITY_OR_OTHER||LS Mean Difference|0.23|STANDARD_ERROR_OF_MEAN|1.36||0.8656|TWO_SIDED|95.0|-2.58|3.04|||ANCOVA|||Pre-Dose on Week 10: p-value was obtained using an ANCOVA model on the sitting-standing difference at Week 10 (Pre-Dose) with the sitting-standing difference at Baseline as a covariate.||3.04|-2.58|0.8656
72542414|NCT00272961|144614637|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.52|STANDARD_ERROR_OF_MEAN|1.4||0.7113|TWO_SIDED|95.0|-3.41|2.36|||ANCOVA|||Pre-Dose on Week 10: p-value was obtained using an ANCOVA model on the sitting-standing difference at Week 10 (Pre-Dose) with the sitting-standing difference at Baseline as a covariate.||2.36|-3.41|0.7113
72542415|NCT00272961|144614637|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.77|STANDARD_ERROR_OF_MEAN|2.21||0.2204|TWO_SIDED|95.0|-7.32|1.77|||ANCOVA|||Post-Dose on Week 10: p-value was obtained using an ANCOVA model on the sitting-standing difference at Week 10 (Post-Dose) with the sitting-standing difference at Baseline as a covariate.||1.77|-7.32|0.2204
72542416|NCT00272961|144614637|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.19|STANDARD_ERROR_OF_MEAN|1.87||0.5298|TWO_SIDED|95.0|-5.04|2.66|||ANCOVA|||Post-Dose on Week 10: p-value was obtained using an ANCOVA model on the sitting-standing difference at Week 10 (Post-Dose) with the sitting-standing difference at Baseline as a covariate.||2.66|-5.04|0.5298
72542417|NCT00272961|144614637|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.95|STANDARD_ERROR_OF_MEAN|1.9||0.3135|TWO_SIDED|95.0|-5.86|1.96|||ANCOVA|||Post-Dose on Week 10: p-value was obtained using an ANCOVA model on the sitting-standing difference at Week 10 (Post-Dose) with the sitting-standing difference at Baseline as a covariate.||1.96|-5.86|0.3135
72542418|NCT00272961|144614637|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.08|STANDARD_ERROR_OF_MEAN|1.95||0.2962|TWO_SIDED|95.0|-6.09|1.93|||ANCOVA|||Post-Dose on Week 10: p-value was obtained using an ANCOVA model on the sitting-standing difference at Week 10 (Post-Dose) with the sitting-standing difference at Baseline as a covariate.||1.93|-6.09|0.2962
72542419|NCT00272961|144614638|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.74|STANDARD_ERROR_OF_MEAN|5.39||0.4933|TWO_SIDED|95.0|-14.84|7.35|||ANCOVA|||Week 10 Sitting: p-value was obtained using an ANCOVA model on the post-dose minus pre-dose difference at Week 10 with the post-dose minus pre-dose difference at Baseline as a covariate.||7.35|-14.84|0.4933
72542420|NCT00272961|144614638|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.85|STANDARD_ERROR_OF_MEAN|4.57||0.408|TWO_SIDED|95.0|-13.26|5.57|||ANCOVA|||Week 10 Sitting: p-value was obtained using an ANCOVA model on the post-dose minus pre-dose difference at Week 10 with the post-dose minus pre-dose difference at Baseline as a covariate.||5.57|-13.26|0.4080
72576652|NCT01564537|144680089|SUPERIORITY||Hazard Ratio (HR)|0.939|||=|0.495|TWO_SIDED|95.0|0.784|1.125|||Log Rank||HR:estimated from Cox Regression with stratification factors: prior therapies, proteasome inhibitor, and ISS Stage at Screening with treatment as factor in model. \<1 hazard ratio for treatment=better prevention of death in drug arm vs control.|||1.125|0.784|=0.495
72576653|NCT01564537|144680090|SUPERIORITY||Hazard Ratio (HR)|0.916|||=|0.764|TWO_SIDED|95.0|0.516|1.626|||Log Rank||HR:estimated from Cox Regression with stratification factors: prior therapies, proteasome inhibitor, and ISS Stage at Screening with treatment as factor in model. \<1 hazard ratio for treatment=better prevention of death in drug arm vs control.|||1.626|0.516|=0.764
72628224|NCT00492557|144784517|NON_INFERIORITY_OR_EQUIVALENCE|The criterion upon which to declare non-inferiority was if the lower limit of the 2-sided 95%CI for the GMT ratios, (13vPnC+TIV relative to 13vPnC administered 1 month after TIV+placebo) was greater than 0.5 (2-fold criterion).|GMT Ratio|0.8|||||TWO_SIDED|95.0|0.59|1.14|||||2-sided 95% CIs for the GMT ratio were calculated by back transformations of the 95% CIs based on the Student t distribution for the mean difference of the logarithmically transformed assay results.|Serotype 18C. The primary null hypothesis was: the log of the GMT in the group receiving 13vPnC + TIV minus the log of the GMT in the group receiving 13vPnC alone (1 month after TIV) \<= -0.693.||1.14|0.59|
72628225|NCT00492557|144784517|NON_INFERIORITY_OR_EQUIVALENCE|The criterion upon which to declare non-inferiority was if the lower limit of the 2-sided 95%CI for the GMT ratios, (13vPnC+TIV relative to 13vPnC administered 1 month after TIV+placebo) was greater than 0.5 (2-fold criterion).|GMT Ratio|0.8|||||TWO_SIDED|95.0|0.61|1.12|||||2-sided 95% CIs for the GMT ratio were calculated by back transformations of the 95% CIs based on the Student t distribution for the mean difference of the logarithmically transformed assay results.|Serotype 19A. The primary null hypothesis was: the log of the GMT in the group receiving 13vPnC + TIV minus the log of the GMT in the group receiving 13vPnC alone (1 month after TIV) \<= -0.693.||1.12|0.61|
72628226|NCT00492557|144784517|NON_INFERIORITY_OR_EQUIVALENCE|The criterion upon which to declare non-inferiority was if the lower limit of the 2-sided 95%CI for the GMT ratios, (13vPnC+TIV relative to 13vPnC administered 1 month after TIV+placebo) was greater than 0.5 (2-fold criterion).|GMT Ratio|0.8|||||TWO_SIDED|95.0|0.57|1.16|||||2-sided 95% CIs for the GMT ratio were calculated by back transformations of the 95% CIs based on the Student t distribution for the mean difference of the logarithmically transformed assay results.|Serotype 19F. The primary null hypothesis was: the log of the GMT in the group receiving 13vPnC + TIV minus the log of the GMT in the group receiving 13vPnC alone (1 month after TIV) \<= -0.693.||1.16|0.57|
72628227|NCT00492557|144784517|NON_INFERIORITY_OR_EQUIVALENCE|The criterion upon which to declare non-inferiority was if the lower limit of the 2-sided 95%CI for the GMT ratios, (13vPnC+TIV relative to 13vPnC administered 1 month after TIV+placebo) was greater than 0.5 (2-fold criterion).|GMT Ratio|0.8|||||TWO_SIDED|95.0|0.54|1.27|||||2-sided 95% CIs for the GMT ratio were calculated by back transformations of the 95% CIs based on the Student t distribution for the mean difference of the logarithmically transformed assay results.|Serotype 23F. The primary null hypothesis was: the log of the GMT in the group receiving 13vPnC + TIV minus the log of the GMT in the group receiving 13vPnC alone (1 month after TIV) \<= -0.693.||1.27|0.54|
72628228|NCT02136914|144784566|SUPERIORITY||Least Squares Mean Difference|-7.9|STANDARD_ERROR_OF_MEAN|2.3||0.0009|TWO_SIDED|95.0|-12.5|-3.3|||Linear Mixed Model w/ Repeated Measures|Change from baseline is a dependent variable, treatment group is a factor, and the baseline value is a covariate.||46 subjects per treatment arm provided 90% power using a 2-sided test at 5% significance.||-3.3|-12.5|0.0009
72628229|NCT02136914|144784567|SUPERIORITY||Least Squares Mean Difference|-9.3|STANDARD_ERROR_OF_MEAN|2.7||0.0008|TWO_SIDED|95.0|-14.7|-4.0|||Linear Mixed Model w/ Repeated Measures|||||-4.0|-14.7|0.0008
72628230|NCT02136914|144784568|SUPERIORITY||Least Squares Mean Difference|2.74|STANDARD_ERROR_OF_MEAN|0.612|<|0.0001|TWO_SIDED|95.0|1.53|3.96||Change from Baseline in ON time without troublesome dyskinesia at Week 12.|Linear Mixed Model w/ Repeated Measures|||||3.96|1.53|<0.0001
72628231|NCT02136914|144784568|SUPERIORITY||Least Squares Mean Difference|2.22|STANDARD_ERROR_OF_MEAN|0.634||0.0007|TWO_SIDED|95.0|0.96|3.47||Change from Baseline in ON time without troublesome dyskinesia at Week 24.|Linear Mixed Model w/ Repeated Measures|||||3.47|0.96|0.0007
72628232|NCT02136914|144784568|SUPERIORITY||Least Squares Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|0.373||0.0171|TWO_SIDED|95.0|-1.64|-0.16||Change from Baseline in OFF time at Week 12.|Linear Mixed Model w/ Repeated Measures|||||-0.16|-1.64|0.0171
72628233|NCT02136914|144784568|SUPERIORITY||Least Squares Mean Difference|-0.81|STANDARD_ERROR_OF_MEAN|0.389||0.0406|TWO_SIDED|95.0|-1.58|-0.04||Change from Baseline in OFF time at Week 24.|Linear Mixed Model w/ Repeated Measures|||||-0.04|-1.58|0.0406
72628234|NCT02136914|144784568|SUPERIORITY||Least Squares Mean Difference|-1.54|STANDARD_ERROR_OF_MEAN|0.508||0.0031|TWO_SIDED|95.0|-2.55|-0.53||Change from Baseline in ON time with troublesome dyskinesia at Week 12.|Linear Mixed Model w/ Repeated Measures|||||-0.53|-2.55|0.0031
72628235|NCT02136914|144784568|SUPERIORITY||Least Squares Mean Difference|-1.45|STANDARD_ERROR_OF_MEAN|0.526||0.0072|TWO_SIDED|95.0|-2.49|-0.4||Change from Baseline in ON time with troublesome dyskinesia at Week 24.|Linear Mixed Model w/ Repeated Measures|||||-0.40|-2.49|0.0072
72628236|NCT02136914|144784569|SUPERIORITY||Least Squares Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|2.74||0.6833|TWO_SIDED|95.0|-6.6|4.3||Change from Baseline in MDS-UPDRS at Week 12.|Linear Mixed Model w/ Repeated Measures|||||4.3|-6.6|0.6833
72628237|NCT02136914|144784569|SUPERIORITY||Least Squares Mean Difference|2.1|STANDARD_ERROR_OF_MEAN|3.58||0.5557|TWO_SIDED|95.0|-5.0|9.2||Change from Baseline in MDS-UPDRS at Week 24.|Linear Mixed Model w/ Repeated Measures|||||9.2|-5.0|0.5557
72628238|NCT02136914|144784570|SUPERIORITY||||||<|0.0001||||||Baseline to Week 12|Cochran-Mantel-Haenszel|||||||<0.0001
72628239|NCT02136914|144784570|SUPERIORITY|||||||0.1071||||||Baseline to Week 24|Cochran-Mantel-Haenszel|||||||0.1071
72628240|NCT01493089|144784580|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.097||||0.563||95.0|||||Regression, Cox|||||||0.563
72628241|NCT01493089|144784581|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.903||||0.712||95.0|||||Regression, Cox|||||||0.712
72628242|NCT01493089|144784582|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.14||||0.457|TWO_SIDED|95.0|||||Regression, Cox|||||||0.457
72628243|NCT01493089|144784583|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.8||||0.625||95.0|-9.7|15.3|||Regression, Cox|||Sustained partial response||15.3|-9.7|0.625
72628244|NCT01493089|144784583|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.2||||0.755|TWO_SIDED|95.0|-15.0|10.6|||Regression, Cox|||Sustained response||10.6|-15.0|0.755
72628245|NCT01493089|144784583|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.8||||0.194|TWO_SIDED|95.0|-3.6|17.2|||Regression, Cox|||Sustained total relief||17.2|-3.6|0.194
72628246|NCT01493089|144784584|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.0||||0.501|TWO_SIDED|95.0|-15.0|7.0|||Regression, Cox|||Sustained partial response||7.0|-15.0|0.501
72628247|NCT01493089|144784584|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.7||||0.518|TWO_SIDED|95.0|-17.6|8.2|||Regression, Cox|||Sustained response||8.2|-17.6|0.518
72628248|NCT01493089|144784584|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.9||||0.794|TWO_SIDED|95.0|-11.2|13.1|||Regression, Cox|||Sustained total relief||13.1|-11.2|0.794
72628249|NCT01493089|144784585|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.4||||0.494|TWO_SIDED|95.0|-6.3|11.2|||Regression, Cox|||Sustained partial response||11.2|-6.3|0.494
72628250|NCT01493089|144784585|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.8||||0.751|TWO_SIDED|95.0|-14.7|9.1|||Regression, Cox|||Sustained response||9.1|-14.7|0.751
72628251|NCT01493089|144784585|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.4||||0.69|TWO_SIDED|95.0|-16.4|9.6|||Regression, Cox|||Sustained total relief||9.6|-16.4|0.690
72628252|NCT03012334|144784598|NON_INFERIORITY|Doses of lasmiditan were considered non-inferior to placebo if the upper 95% confidence limit on the difference in Standard Deviation of Lateral Position (SDLP) between that dose and placebo was less than 4.4 cm and lower doses also did not exceed the non-inferiority (NI) margin.|LS Mean|9.86|||<|0.001|TWO_SIDED|95.0|7.39|12.33||P-value is obtained from mixed effect model for testing difference versus placebo equals to zero.|Mixed Models Analysis|||||12.33|7.39|<.001
72628253|NCT03012334|144784598|NON_INFERIORITY|Doses of lasmiditan were considered non-inferior to placebo if the upper 95% confidence limit on the difference in SDLP between that dose and placebo was less than 4.4 cm and lower doses also did not exceed the non-inferiority (NI) margin.|LS Mean|15.35|||<|0.001|TWO_SIDED|95.0|12.87|17.82||P-value is obtained from mixed effect model for testing difference versus placebo equals to zero.|Mixed Models Analysis|||||17.82|12.87|<0.001
72628254|NCT03012334|144784598|NON_INFERIORITY|Doses of lasmiditan were considered non-inferior to placebo if the upper 95% confidence limit on the difference in SDLP between that dose and placebo was less than 4.4 cm and lower doses also did not exceed the non-inferiority (NI) margin.|LS Mean|21.06|||<|0.001|TWO_SIDED|95.0|18.6|23.52||P-value is obtained from mixed effect model for testing difference versus placebo equals to zero.|Mixed Models Analysis|||||23.52|18.60|<0.001
72628255|NCT03012334|144784598|SUPERIORITY||LS Mean|22.71|||<|0.001|TWO_SIDED|95.0|20.23|25.18|||Mixed Models Analysis|||||25.18|20.23|<0.001
72628256|NCT03012334|144784598|SUPERIORITY||LS Mean|-12.85|||<|0.001|TWO_SIDED|95.0|-15.32|-10.38|||Mixed Models Analysis|||||-10.38|-15.32|<0.001
72628257|NCT03012334|144784598|SUPERIORITY||LS Mean|-7.36|||<|0.001|TWO_SIDED|95.0|-9.84|-4.88|||Mixed Models Analysis|||||-4.88|-9.84|<0.001
72628258|NCT03012334|144784598|SUPERIORITY||LS Mean|-1.65||||0.19|TWO_SIDED|95.0|-4.11|0.82|||Mixed Models Analysis|||||0.82|-4.11|0.19
72329420|NCT03744910|144184289|OTHER||Treatment difference|-2.75|STANDARD_ERROR_OF_MEAN|1.563|||TWO_SIDED|95.0|-5.84|0.35||||||||0.35|-5.84|
72628259|NCT03012334|144784599|SUPERIORITY||LS Mean|1.6|||<|0.0001|TWO_SIDED|95.0|1.1744|2.0335|||Mixed Models Analysis|||||2.0335|1.1744|<0.0001
72628260|NCT03012334|144784599|SUPERIORITY||LS Mean|2.3|||<|0.0001|TWO_SIDED|95.0|1.8306|2.6926|||Mixed Models Analysis|||||2.6926|1.8306|<.0001
72628261|NCT03012334|144784599|SUPERIORITY||LS Mean|2.9|||<|0.0001|TWO_SIDED|95.0|2.4239|3.28|||Mixed Models Analysis|||||3.2800|2.4239|<0.0001
72628262|NCT03012334|144784599|SUPERIORITY||LS Mean|3.4|||<|0.0001|TWO_SIDED|95.0|2.9568|3.8193|||Mixed Models Analysis|||||3.8193|2.9568|<0.0001
72628263|NCT03012334|144784599|SUPERIORITY||LS Mean|-1.8|||<|0.0001|TWO_SIDED|95.0|-2.2137|-1.3546|||Mixed Models Analysis|||||-1.3546|-2.2137|<0.0001
72628264|NCT03012334|144784599|SUPERIORITY||LS Mean|-1.1|||<|0.0001|TWO_SIDED|95.0|-1.5574|-0.6956|||Mixed Models Analysis|||||-0.6956|-1.5574|<0.0001
72628265|NCT03012334|144784599|SUPERIORITY||LS Mean|-0.5||||0.0142|TWO_SIDED|95.0|-0.9642|-0.1081|||Mixed Models Analysis|||||-0.1081|-0.9642|0.0142
72628266|NCT03012334|144784601|SUPERIORITY||LS Mean|-12.6|||<|0.0001|TWO_SIDED|95.0|-18.6895|-6.5006|||Mixed Models Analysis|||||-6.5006|-18.6895|<.0001
72628267|NCT03012334|144784601|SUPERIORITY||LS Mean|-24.2|||<|0.0001|TWO_SIDED|95.0|-30.3631|-18.1357|||Mixed Models Analysis|||||-18.1357|-30.3631|<.0001
72628268|NCT03012334|144784601|SUPERIORITY||LS Mean|-28.4|||<|0.0001|TWO_SIDED|95.0|-34.442|-22.2897|||Mixed Models Analysis|||||-22.2897|-34.4420|<.0001
72628269|NCT03012334|144784601|SUPERIORITY||LS Mean|-30.4|||<|0.0001|TWO_SIDED|95.0|-36.5068|-24.277|||Mixed Models Analysis|||||-24.2770|-36.5068|<0.0001
72628270|NCT03012334|144784601|SUPERIORITY||LS Mean|17.8|||<|0.0001|TWO_SIDED|95.0|11.7029|23.8908|||Mixed Models Analysis|||||23.8908|11.7029|<.0001
72628271|NCT03012334|144784601|SUPERIORITY||LS Mean|6.1||||0.0489|TWO_SIDED|95.0|0.0297|12.2554|||Mixed Models Analysis|||||12.2554|0.0297|0.0489
72628272|NCT03012334|144784601|SUPERIORITY||LS Mean|2.0||||0.5123|TWO_SIDED|95.0|-4.05|8.1021|||Mixed Models Analysis|||||8.1021|-4.0500|0.5123
72628273|NCT03012334|144784601|SUPERIORITY||LS Mean|-26.4|||<|0.0001|TWO_SIDED|95.0|-32.4956|-20.3628|||Mixed Models Analysis|||||-20.3628|-32.4956|<.0001
72628274|NCT03012334|144784601|SUPERIORITY||LS Mean|-37.8|||<|0.0001|TWO_SIDED|95.0|-43.927|-31.7537|||Mixed Models Analysis|||||-31.7537|-43.9270|<.0001
72628275|NCT03012334|144784601|SUPERIORITY||LS Mean|-46.8|||<|0.0001|TWO_SIDED|95.0|-52.8147|-40.7268|||Mixed Models Analysis|||||-40.7268|-52.8147|<.0001
72628276|NCT03012334|144784601|SUPERIORITY||LS Mean|-52.6|||<|0.0001|TWO_SIDED|95.0|-58.649|-46.4682|||Mixed Models Analysis|||||-46.4682|-58.6490|<0.0001
72628277|NCT03012334|144784601|SUPERIORITY||LS Mean|26.1|||<|0.0001|TWO_SIDED|95.0|20.0635|32.1953|||Mixed Models Analysis|||||32.1953|20.0635|<.0001
72628278|NCT03012334|144784601|SUPERIORITY||LS Mean|14.7|||<|0.0001|TWO_SIDED|95.0|8.6325|20.804|||Mixed Models Analysis|||||20.8040|8.6325|<.0001
72628279|NCT03012334|144784601|SUPERIORITY||LS Mean|5.8||||0.0605|TWO_SIDED|95.0|-0.256|11.8317|||Mixed Models Analysis|||||11.8317|-0.2560|0.0605
72628280|NCT03012334|144784602|SUPERIORITY||LS Mean|-4.5|||<|0.001|TWO_SIDED|95.0|-6.14|-2.85|||Mixed Models Analysis|||||-2.85|-6.14|<0.001
72628281|NCT03012334|144784602|SUPERIORITY||LS Mean|-6.9|||<|0.001|TWO_SIDED|95.0|-8.58|-5.28|||Mixed Models Analysis|||||-5.28|-8.58|<0.001
72628282|NCT03012334|144784602|SUPERIORITY||LS Mean|-8.9|||<|0.001|TWO_SIDED|95.0|-10.52|-7.23|||Mixed Models Analysis|||||-7.23|-10.52|<0.001
72628283|NCT03012334|144784602|SUPERIORITY||LS Mean|-11.2|||<|0.001|TWO_SIDED|95.0|-12.81|-9.51|||Mixed Models Analysis|||||-9.51|-12.81|<0.001
72628284|NCT03012334|144784602|SUPERIORITY||LS Mean|6.7|||<|0.001|TWO_SIDED|95.0|5.02|8.31|||Mixed Models Analysis|||||8.31|5.02|<0.001
72628285|NCT03012334|144784602|SUPERIORITY||LS Mean|4.2|||<|0.001|TWO_SIDED|95.0|2.58|5.88|||Mixed Models Analysis|||||5.88|2.58|<0.001
72628286|NCT03012334|144784602|SUPERIORITY||LS Mean|2.3|||<|0.007|TWO_SIDED|95.0|0.64|3.93|||Mixed Models Analysis|||||3.93|0.64|<0.007
72628287|NCT03012334|144784603|SUPERIORITY||LS Mean|1.439|||<|0.0001|TWO_SIDED|95.0|1.2198|1.6583|||Mixed Models Analysis|||||1.6583|1.2198|<0.0001
72410248|NCT03224468|144328803|SUPERIORITY|Power was determined to be 90.4% using a Monte Carlo simulation approach in which data were simulated from a multi-level linear regression model with a subject-varying random intercept, a shared baseline across WLC and MMC, and fixed effects for a change over each time point. Simulated data were fit with a linear model estimated via GEE - simulations were repeated 1000 times and power was estimated as the proportion where the contrast between WLC and MM had p\<0.05.|Mean Difference (Net)|-0.79|STANDARD_ERROR_OF_MEAN|0.7|<|0.001|TWO_SIDED|95.0|-1.3|-0.43||The p-value is adjusted for multiple comparisons using per Benjamini \& Hochberg (1995) across the five primary outcome measures. Effects were deemed significant for p\<0.05.|Regression, Linear|Estimates were obtained using generalized estimating equations (GEE) with robust standard errors obtained by the sandwich estimator.|Estimate is the mean difference in number of symptoms for MM above and beyond WLC (positive values denote higher number of symptoms for MM).|The mean difference in number of symptoms between the MM and WLC groups was estimated via a linear model with a dummy-coded contrast (0 for WLC, 1 for MM). The model adjusted for change at weeks 4 and 12 of the study, and for a subject's number of symptoms at baseline.||-0.43|-1.30|<0.001
72410249|NCT03224468|144328804|SUPERIORITY||Mean Difference (Net)|0.8|STANDARD_ERROR_OF_MEAN|0.9|||TWO_SIDED|95.0|-1.0|2.5|||||Estimate is the mean difference in number of symptoms for MM above and beyond WLC (positive values denote higher number of symptoms for MM).|The mean difference in number of symptoms between the MM and WLC groups was estimated via a linear model with a dummy-coded contrast (0 for WLC, 1 for MM). The model adjusted for change at weeks 4 and 12 of the study, and for a subject's score at baseline.||2.5|-1.0|
72410250|NCT03224468|144328806|SUPERIORITY||Mean Difference (Net)|-7.7|STANDARD_ERROR_OF_MEAN|5.7|||TWO_SIDED|95.0|-19.0|3.5|||||Estimate is the mean difference in the congruency cost on response time for MM above and beyond WLC (positive values indicate higher cost for MM).|The mean difference in number of symptoms between the MM and WLC groups was estimated via a linear model with a dummy-coded contrast (0 for WLC, 1 for MM). The model adjusted for change at week 12 of the study, and for a subject's score at baseline.||3.5|-19.0|
72410251|NCT03224468|144328807|SUPERIORITY||Mean Difference (Net)|-24.1|STANDARD_ERROR_OF_MEAN|11.2|||TWO_SIDED|95.0|-45.9|-2.2|||||Estimate is the mean difference in the switching cost on response time for MM above and beyond WLC (positive values indicate higher cost for MM).|The mean difference in number of symptoms between the MM and WLC groups was estimated via a linear model with a dummy-coded contrast (0 for WLC, 1 for MM). The model adjusted for change at week 12 of the study, and for a subject's score at baseline.||-2.2|-45.9|
72410252|NCT03224468|144328808|SUPERIORITY||Mean Difference (Net)|0.002|STANDARD_ERROR_OF_MEAN|0.005|||TWO_SIDED|95.0|-0.007|0.011|||||Estimate is the mean difference in discriminability for MM above and beyond WLC (positive values indicate better ability to identify target items for MM).|The mean difference in number of symptoms between the MM and WLC groups was estimated via a linear model with a dummy-coded contrast (0 for WLC, 1 for MM). The model adjusted for change at week 12 of the study, and for a subject's score at baseline.||0.011|-0.007|
72410253|NCT03224468|144328809|SUPERIORITY||Mean Difference (Net)|-0.1|STANDARD_ERROR_OF_MEAN|0.9|||TWO_SIDED|95.0|-1.8|1.7|||||Estimate is the mean difference in number of total errors for MM above and beyond WLC (positive values indicate greater number of errors for MM).|The mean difference in number of symptoms between the MM and WLC groups was estimated via a linear model with a dummy-coded contrast (0 for WLC, 1 for MM). The model adjusted for change at week 12 of the study, and for a subject's score at baseline.||1.7|-1.8|
72410254|NCT03224468|144328810|SUPERIORITY||Mean Difference (Net)|-3.6|STANDARD_ERROR_OF_MEAN|2.0|||TWO_SIDED|95.0|-7.4|0.3|||||Estimate is the mean difference in number of repetition errors for MM above and beyond WLC (positive values indicate greater number of errors for MM).|The mean difference in number of symptoms between the MM and WLC groups was estimated via a linear model with a dummy-coded contrast (0 for WLC, 1 for MM). The model adjusted for change at week 12 of the study, and for a subject's score at baseline.||0.3|-7.4|
72410255|NCT03224468|144328811|SUPERIORITY||Mean Difference (Net)|-0.1|STANDARD_ERROR_OF_MEAN|0.1|||TWO_SIDED|95.0|-0.2|0.1|||||Estimate is the mean difference in discriminability for MM above and beyond WLC (positive values indicate a greater ability to recognize previously studied words for MM).|The mean difference in number of symptoms between the MM and WLC groups was estimated via a linear model with a dummy-coded contrast (0 for WLC, 1 for MM). The model adjusted for change at week 12 of the study, and for a subject's score at baseline.||0.1|-0.2|
72410256|NCT03224468|144328812|SUPERIORITY||Mean Difference (Net)|0.4|STANDARD_ERROR_OF_MEAN|0.3|||TWO_SIDED|95.0|-0.2|1.0|||||Estimate is the mean difference in number recalled for MM above and beyond WLC (positive values indicate a greater ability to recall previously studied words for MM).|The mean difference in number of symptoms between the MM and WLC groups was estimated via a linear model with a dummy-coded contrast (0 for WLC, 1 for MM). The model adjusted for change at week 12 of the study, and for a subject's score at baseline.||1.0|-0.2|
72577178|NCT04414345|144680916|SUPERIORITY||Disease Rate Ratio|0.98|STANDARD_DEVIATION|0.1|||TWO_SIDED|95.0|0.797|1.188||Posterior probability that the disease rate ratio (DRR) is less than 1 (i.e. CNM-Au8 slowed progression) was 0.59059. NOTE: p-value is not provided for Bayesian model.|Bayesian shared-parameter model|A Bayesian shared-parameter model of change in disease severity as measured by ALSFRS-R total score and mortality.|"DDR \<1 imply slowing of disease progression by CNM-Au8 relative to placebo. Note: reported Confidence Interval is actually a Bayesian credible interval."||"The DRR parameter for active treatment represents the relative change to the rate of decline of ALSFRS-R and the rate of mortality of treated participant relative to a placebo participant. The estimated DRR can also be interpreted as the average rate of decline in function and mortality.~The model includes covariates for baseline use of edaravone, baseline use of riluzole, months since onset of symptoms, and pre-baseline slope of ALSFRS-R, and random effects for regimen and participant-specific slopes."|1.188|0.797|
72410257|NCT02461589|144328813|OTHER||Treatment difference|-1.04|||<|0.0001|TWO_SIDED|95.0|-1.3|-0.77|||Mixed Models Analysis|||||-0.77|-1.30|<0.0001
72410258|NCT02461589|144328813|OTHER||Treatment difference|-1.34|||<|0.0001|TWO_SIDED|95.0|-1.61|-1.08|||Mixed Models Analysis|||||-1.08|-1.61|<0.0001
72410259|NCT02461589|144328813|OTHER||Treatment difference|-1.69|||<|0.0001|TWO_SIDED|95.0|-1.95|-1.42|||Mixed Models Analysis|||||-1.42|-1.95|<0.0001
72410260|NCT02461589|144328813|OTHER||Treatment difference|-1.86|||<|0.0001|TWO_SIDED|95.0|-2.12|-1.6|||Mixed Models Analysis|||||-1.60|-2.12|<0.0001
72628288|NCT03012334|144784603|SUPERIORITY||LS Mean|2.018|||<|0.0001|TWO_SIDED|95.0|1.7981|2.238|||Mixed Models Analysis|||||2.2380|1.7981|<0.0001
72329421|NCT03430843|144184328|SUPERIORITY||Hazard Ratio (HR)|0.7||||0.0001|TWO_SIDED|95.0|0.57|0.85|||1-sided, Log Rank Test|||||0.85|0.57|0.0001
72329422|NCT02574078|144184362|SUPERIORITY||Hazard Ratio (HR)|0.7||||0.505|TWO_SIDED|95.0|0.24|2.03|||Unstratified log-rank|||||2.03|0.24|0.5050
72329423|NCT02574078|144184362|SUPERIORITY||Hazard Ratio (HR)|0.74||||0.6284|TWO_SIDED|95.0|0.22|2.54|||Unstratified log-rank|||||2.54|0.22|0.6284
72421499|NCT01392300|144354183|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.09||0.429|TWO_SIDED|95.0|-0.2|0.1|||ANCOVA|||||0.1|-0.2|0.429
72628289|NCT03012334|144784603|SUPERIORITY||LS Mean|2.572|||<|0.0001|TWO_SIDED|95.0|2.3536|2.7909|||Mixed Models Analysis|||||2.7909|2.3536|<0.0001
72628290|NCT03012334|144784603|SUPERIORITY||LS Mean|2.553|||<|0.0001|TWO_SIDED|95.0|2.3331|2.773|||Mixed Models Analysis|||||2.7730|2.3331|<0.0001
72628291|NCT03012334|144784603|SUPERIORITY||LS Mean|-1.114|||<|0.0001|TWO_SIDED|95.0|-1.3333|-0.8948|||Mixed Models Analysis|||||-0.8948|-1.3333|<0.0001
72628292|NCT03012334|144784603|SUPERIORITY||LS Mean|-0.535|||<|0.0001|TWO_SIDED|95.0|-0.7549|-0.3151|||Mixed Models Analysis|||||-0.3151|-0.7549|<0.0001
72628293|NCT03012334|144784603|SUPERIORITY||LS Mean|0.019||||0.8629|TWO_SIDED|95.0|-0.1995|0.2379|||Mixed Models Analysis|||||0.2379|-0.1995|0.8629
72628294|NCT03012334|144784605|SUPERIORITY||LS Mean|0.18||||0.0002|TWO_SIDED|95.0|0.0849|0.2746|||Mixed Models Analysis|||||0.2746|0.0849|0.0002
72628295|NCT03012334|144784605|SUPERIORITY||LS Mean|0.303|||<|0.0001|TWO_SIDED|95.0|0.2082|0.3985|||Mixed Models Analysis|||||0.3985|0.2082|<.0001
72628296|NCT03012334|144784605|SUPERIORITY||LS Mean|0.372|||<|0.0001|TWO_SIDED|95.0|0.277|0.4662|||Mixed Models Analysis|||||0.4662|0.2770|<.0001
72628297|NCT03012334|144784605|SUPERIORITY||LS Mean|0.603|||<|0.0001|TWO_SIDED|95.0|0.508|0.6983|||Mixed Models Analysis|||||0.6983|0.5080|<.0001
72628298|NCT03012334|144784605|SUPERIORITY||LS Mean|-0.423|||<|0.0001|TWO_SIDED|95.0|-0.5183|-0.3286|||Mixed Models Analysis|||||-0.3286|-0.5183|<.0001
72628299|NCT03012334|144784605|SUPERIORITY||LS Mean|-0.3|||<|0.0001|TWO_SIDED|95.0|-0.3949|-0.2047|||Mixed Models Analysis|||||-0.2047|-0.3949|<0.0001
72628300|NCT03012334|144784605|SUPERIORITY||LS Mean|-0.232|||<|0.0001|TWO_SIDED|95.0|-0.3261|-0.137|||Mixed Models Analysis|||||-0.1370|-0.3261|<0.0001
72628301|NCT01008618|144784616|SUPERIORITY_OR_OTHER|||||||0.0846|||||||Log Rank|||||||0.0846
72628302|NCT00744861|144784629|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9905|||||||Cochran-Mantel-Haenszel|site stratified||||||0.9905
72410261|NCT01038921|144328838|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.0||||0.013|||||||Mixed Models Analysis|||Average change in systolic blood pressure from pre-treatment baseline to post-treatment at 10 weeks when those subjects were on Melatonin was compared to the average change in systolic blood pressure from pre-treatment baseline to post-treatment at 10 weeks when those same subjects were on Placebo using an intent-to-treat mixed model. Power was estimated based on having 30 subjects completing both the melatonin arm and the placebo arm.||||0.013
72410262|NCT01978119|144328839|NON_INFERIORITY_OR_EQUIVALENCE|Non- inferiority was demonstrated if lower limit of the CI (0.025 one sided significance level) for the difference of the mean change from Baseline in trough FEV1 of FSC administered BID by capsule-based unit dose DPI versus FSC administered BID by multi-dose DPI is greater than -125 milliliter (mL).|Mean Difference (Net)|0.028|||||TWO_SIDED|95.0|-0.024|0.08|||Repeated Measures Mixed Models|||||0.080|-0.024|
72410263|NCT01978119|144328840|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.352|||||TWO_SIDED|95.0|-1.039|0.334||||||||0.334|-1.039|
72410264|NCT01978119|144328841|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.278|||||TWO_SIDED|95.0|-0.372|0.927||||||||0.927|-0.372|
72410265|NCT01978119|144328842|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.007|||||TWO_SIDED|95.0|-0.074|0.088|||||Day 28 Change from Baseline Analysis|||0.088|-0.074|
72410266|NCT01978119|144328842|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.022||||||95.0|-0.049|0.092|||||Day 56 Change from Baseline Analysis|||0.092|-0.049|
72410267|NCT01978119|144328843|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.35|||||TWO_SIDED|95.0|-1.34|10.05||||||||10.05|-1.34|
72410268|NCT01978119|144328844|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.06|||||TWO_SIDED|95.0|-0.2|0.09||||||||0.09|-0.20|
72410269|NCT01978119|144328846|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.25|||||TWO_SIDED|95.0|-6.97|2.46||||||||2.46|-6.97|
72410270|NCT01978119|144328847|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.2|||||TWO_SIDED|95.0|-0.9|0.5||||||||0.5|-0.9|
72577179|NCT04414345|144680918|SUPERIORITY||Mean Difference (Net)|-0.78|STANDARD_ERROR_OF_MEAN|1.766||0.657|TWO_SIDED|95.0|-4.25|2.68|||Mixed Models Analysis|Covariates include baseline use of edaravone and riluzole, months since symptom onset, and pre-baseline ALSFRS-R slope.|CNM-Au8 24-week change from baseline relative to placebo 24-week change from baseline.|||2.68|-4.25|0.6570
72410271|NCT01978119|144328848|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.77|||||TWO_SIDED|95.0|-4.64|3.11||||||||3.11|-4.64|
72410272|NCT01958918|144328878|SUPERIORITY|||||||0.185|||||||ANOVA|||||||0.1850
72410273|NCT00659269|144328886|SUPERIORITY_OR_OTHER|||||||0.91|TWO_SIDED||||||ANOVA|||||||0.91
72410274|NCT04327934|144328890|EQUIVALENCE|We compared groups across treatments||||||0.018|||||||ANOVA|||||||0.018
72410275|NCT04327934|144328891|EQUIVALENCE|We compared across groups and within groups over time.|||||<|0.016|||||||ANOVA|||||||<0.016
72410276|NCT04327934|144328891|EQUIVALENCE|We compared across groups and within groups over time.||||||0.08|||||||ANOVA|||||||0.08
72410277|NCT04327934|144328894|OTHER|||||||0.05||||||Friedman's tests to compare slopes|Friedman's test|||||||0.05
72410278|NCT04327934|144328896|OTHER|||||||0.023|||||||t-test, 2 sided|||||||0.023
72410279|NCT04327934|144328896|OTHER||||||<|0.04|||||||ANOVA|||||||<0.04
72410280|NCT04327934|144328897|EQUIVALENCE|We compared groups across treatments||||||0.0023|||||||ANOVA|||||||0.0023
72410281|NCT04327934|144328898|OTHER||||||<|0.04|||||||ANOVA|||||||<0.04
72410282|NCT04327934|144328899|OTHER||||||<|0.04|||||||ANOVA|||||||<0.04
72410283|NCT03095417|144328913|SUPERIORITY|||||||0.747|||||||Mixed Models Analysis|||||||0.747
72410284|NCT03095417|144328914|SUPERIORITY|||||||0.032|||||||Mixed Models Analysis|||||||0.032
72410285|NCT03095417|144328915|SUPERIORITY|||||||0.264|||||||Mixed Models Analysis|||||||0.264
72410286|NCT03095417|144328916|SUPERIORITY|||||||0.511|||||||Mixed Models Analysis|||||||0.511
72410287|NCT03095417|144328917|SUPERIORITY|||||||0.677|||||||Mixed Models Analysis|||||||0.677
72410288|NCT03095417|144328918|SUPERIORITY|||||||0.815|||||||Mixed Models Analysis|||||||0.815
72410289|NCT03095417|144328919|SUPERIORITY|||||||0.719|||||||Mixed Models Analysis|||||||0.719
72410290|NCT03095417|144328920|SUPERIORITY|||||||0.346|||||||Mixed Models Analysis|||||||0.346
72410291|NCT03095417|144328921|SUPERIORITY|||||||0.91|||||||Mixed Models Analysis|||||||0.910
72410292|NCT03095417|144328922|SUPERIORITY|||||||0.794|||||||Mixed Models Analysis|||||||0.794
72410293|NCT03095417|144328923|SUPERIORITY|||||||0.626|||||||Mixed Models Analysis|||||||0.626
72410294|NCT03095417|144328924|SUPERIORITY|||||||0.774|||||||Mixed Models Analysis|||||||0.774
72410295|NCT01047683|144328930|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-33.1|||<|0.0001|TWO_SIDED|95.0|-46.6|-21.5||Nonparametric analysis p values were planned using Wilcoxon rank-sum test for each comparison between AMR101 and placebo. Comparisons between AMR101 and placebo were made using a significance level of 0.01 for the primary endpoint.|Wilcoxon rank-sum test|A prespecified step-down testing procedure was used to control Type I error rate using 4 g/day vs placebo then, if significant, 2 g/day vs placebo.|Median differences between the treatment groups and 95% CIs were estimated with the Hodges-Lehmann method.|A standard deviation of 45% in the TG measurements and a significance level of P \< 0.01 required a sample size of 69 completed patients per treatment group to provide greater than or equal to 90% power to detect a difference of 30% between AMR101 and placebo in the percentage of change from baseline in the fasting TG levels.||-21.5|-46.6|<0.0001
72410296|NCT01047683|144328930|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-19.7||||0.0051|TWO_SIDED|95.0|-33.3|-5.6|||Wilcoxon rank-sum test||Median differences between the treatment groups and 95% CIs were estimated with the Hodges-Lehmann method.|||-5.6|-33.3|0.0051
72410297|NCT01047683|144328931|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-28.6||||0.0005|TWO_SIDED|95.0|-43.4|-13.9||Nonparametric analysis p values were planned using Wilcoxon rank-sum test for each comparison between AMR101 and placebo. Comparisons between AMR101 and placebo were made using a significance level of 0.05 for secondary and exploratory endpoints.|Wilcoxon rank-sum test|A prespecified step-down testing procedure was used to control Type I error rate using 4 g/day vs placebo then, if significant, 2 g/day vs placebo.|Median differences between the treatment groups and 95% CIs were estimated with the Hodges-Lehmann method.|||-13.9|-43.4|0.0005
72628303|NCT02797821|144784639|OTHER||Least Squares (LS) Means Difference|-1.88|||<|0.0001|TWO_SIDED|95.0|-2.544|-1.216||REML-based repeated measures mixed model (treatment, visit, sex, Baseline PPi, Baseline weight group \[≥median vs \< median\], and study drug lot assignment as factors) with an unstructured covariance structure for within-participant correlation.|REML|A fixed sequence testing procedure was used to control the Type I error rate. A statistical adjustment of p-values was not performed.||A fixed sequence testing procedure was performed to compare the 3.0 mg/kg cohort with the 0.5 mg/kg cohort first. The hypothesis testing for the second comparison of the 2.0 mg/kg cohort compared with the 0.5 mg/kg cohort was only performed if the null hypothesis was rejected for the previous comparison at a significance level of 0.05 (p-value \<0.05). The primary endpoint was met if the null hypothesis was rejected for both comparisons at a significance level of 0.05 (both p-values \<0.05).||-1.216|-2.544|<0.0001
72628304|NCT02797821|144784639|OTHER||LS Means Difference|-1.193||||0.0008|TWO_SIDED|95.0|-1.805|-0.581||REML-based repeated measures mixed model (treatment, visit, sex, Baseline PPi, Baseline weight group \[≥median vs \< median\], and study drug lot assignment as factors) with an unstructured covariance structure for within-participant correlation.|REML|A fixed sequence testing procedure was used to control the Type I error rate. A statistical adjustment of p-values was not performed.||A fixed sequence testing procedure was performed to compare the 3.0 mg/kg cohort with the 0.5 mg/kg cohort first. The hypothesis testing for the second comparison of the 2.0 mg/kg cohort compared with the 0.5 mg/kg cohort was only performed if the null hypothesis was rejected for the first comparison at a significance level of 0.05 (p-value \<0.05). The primary endpoint was met if the null hypothesis was rejected for both comparisons at a significance level of 0.05 (both p-values \<0.05).||-0.581|-1.805|0.0008
72628305|NCT02797821|144784640|OTHER||LS Means Difference|-34.047||||0.0128|TWO_SIDED|95.0|-60.171|-7.922||REML-based repeated measures mixed model (treatment, visit, sex, Baseline PPi, Baseline weight group \[≥ median versus \< median\], and study drug lot assignment as factors) with an unstructured covariance structure for within-participant correlation.|Restricted maximum likelihood-based|A statistical adjustment of p-values was not performed.||||-7.922|-60.171|0.0128
72628306|NCT02797821|144784640|OTHER||LS Means Difference|-29.492||||0.0239|TWO_SIDED|95.0|-54.723|-4.261||REML-based repeated measures mixed model (treatment, visit, sex, Baseline PPi, Baseline weight group \[≥ median versus \< median\], and study drug lot assignment as factors) with an unstructured covariance structure for within-participant correlation.|Restricted maximum likelihood-based|A statistical adjustment of p-values was not performed.||||-4.261|-54.723|0.0239
72628307|NCT03961308|144784682|OTHER|Geometric least-squares means (LSMs) were calculated by exponentiating the LSMs derived from analysis of covariance (ANCOVA) with weight as a covariate. Confidence intervals (CIs) were calculated using treatment standard errors from the ANCOVA model and t-statistic for error degrees of freedom.|Ratio of Geometric LSMs|1.0734|||||TWO_SIDED|90.0|0.9963|1.1565||||||||1.1565|0.9963|
72628308|NCT03961308|144784683|OTHER|Geometric LSMs were calculated by exponentiating the LSMs derived from ANCOVA with weight as a covariate. CIs were calculated using treatment standard errors from the ANCOVA model and t-statistic for error degrees of freedom.|Ratio of Geometric LSMs|1.0824|||||TWO_SIDED|90.0|1.0169|1.1521||||||||1.1521|1.0169|
72628309|NCT03961308|144784684|OTHER|Geometric LSMs were calculated by exponentiating the LSMs derived from ANCOVA with weight as a covariate. CIs were calculated using treatment standard errors from the ANCOVA model and t-statistic for error degrees of freedom.|Ratio of Geometric LSMs|1.0465|||||TWO_SIDED|90.0|0.9935|1.1023||||||||1.1023|0.9935|
72628310|NCT01538199|144784697|SUPERIORITY_OR_OTHER|||||||0.04||||||a priori threshold for statistical significance: p≤0.05|t-test, 1 sided|We used a modified intent-to-treat approach with LOCF and unpaired Student's t-test (one-way), comparing the change in total severity score.||||||0.04
72628311|NCT01538199|144784697|SUPERIORITY_OR_OTHER|||||||0.08||||||a priori threshold for statistical significance: p≤0.05|t-test, 2 sided|Modified intent-to-treat approach with lost observation carried forward (LOCF) and a two-tailed t-test to compare the change in total severity score.||||||0.08
72329424|NCT02574078|144184362|SUPERIORITY||Hazard Ratio (HR)|0.7||||0.1988|TWO_SIDED|95.0|0.4|1.22|||Unstratified log-rank|||||1.22|0.40|0.1988
72329425|NCT02574078|144184362|SUPERIORITY||Hazard Ratio (HR)|0.73||||0.2722|TWO_SIDED|95.0|0.42|1.28|||Unstratified log-rank|||||1.28|0.42|0.2722
72628312|NCT01538199|144784697|SUPERIORITY_OR_OTHER|||||||0.01||||||a priori threshold for statistical significance: p≤0.05|t-test, 1 sided|One-tailed t-test to compare the change in total severity score for treatment completers.||This analysis includes only treatment completers (participants who who were followed for the entire 8-week study period and who received a clinical assessment immediately after).||||0.01
72628313|NCT01538199|144784697|SUPERIORITY_OR_OTHER|||||||0.02||||||a priori threshold for statistical significance: p≤0.05|t-test, 2 sided|Two-tailed t-test to compare the change in total severity score for treatment completers.||This analysis includes only treatment completers (participants who who were followed for the entire 8-week study period and who received a clinical assessment immediately after).||||0.02
72628314|NCT01538199|144784697|SUPERIORITY_OR_OTHER|||||||0.004|||||||t-test, 2 sided|||By means of a paired t-test we tested the significance of the change in the mean HAM-D17 total score (from baseline) to week 8. Although the primary comparison was with the last assessment (week 8). A last observation carried forward (LOCF) was also performed to account for one missing value at week 8.||||0.004
72628315|NCT01538199|144784700|SUPERIORITY_OR_OTHER|||||||0.18||||||a priori threshold for statistical significance: p≤0.05|t-test, 1 sided|Last observation carried forward (LOCF), one tailed t-test to compare change in QIDS score.||||||0.18
72628316|NCT01538199|144784700|SUPERIORITY_OR_OTHER|||||||0.01||||||a priori threshold for statistical significance: p≤0.05|t-test, 1 sided|One-tailed t-test to measure the change in QIDS score for treatment completers.||This analysis includes only treatment completers (participants who who were followed for the entire 8-week study period and who received a clinical assessment immediately after). One treatment completer in Group 1 was excluded because they consistently skipped several answers across self-rated scales for the duration of the study.||||0.01
72628317|NCT01538199|144784700|SUPERIORITY_OR_OTHER|||||||0.02||||||a priori threshold for statistical significance: p≤0.05|t-test, 2 sided|Two-tailed t-test measuring change in QIDS score for treatment completers.||This analysis includes only treatment completers (participants who who were followed for the entire 8-week study period and who received a clinical assessment immediately after). One treatment completer in Group 1 was excluded because they consistently skipped several answers across self-rated scales for the duration of the study.||||0.02
72628318|NCT03950856|144784702|OTHER||Difference in Percentage|1.3||||0.538|TWO_SIDED|95.0|-3.3|4.8|||Miettinen & Nurminen||V114 Combined Lots minus Prevnar 13™|Injection site erythema: V114 Combined Lots - Prevnar 13™||4.8|-3.3|0.538
72542664|NCT00575328|144615284|SUPERIORITY|Analysis is a test of statistical significance to evaluate whether the results are consistent with the assumption of there being no difference in the clinical improvement (i.e. change in MGH-SD score) of the two treatments (null hypothesis).|Mean Difference (Final Values)|3.6|STANDARD_DEVIATION|4.5||0.38|TWO_SIDED|95.0|-6.7|13.97||No adjustment for multiple comparisons. P value for significance set a priori at P\<0.05.|t-test, 2 sided|||Null hypothesis: There will be no difference in clinical improvement (i.e. change in MGH-SD score) between treatment arms. No formal power analysis was carried out, given the small study sample.|Analysis was not truly informative since the analyzable sample (n=6) was too small. Results should be interpreted with caution.|13.97|-6.7|0.38
72542665|NCT02522949|144615307|SUPERIORITY|||||||0.7146|||||||ANCOVA|||Oropharyngeal||||0.7146
72542666|NCT02522949|144615307|SUPERIORITY|||||||0.3543|||||||ANCOVA|||Nasal||||0.3543
72542667|NCT02522949|144615315|OTHER|||||||0.0232|||||||Exact Wilcoxon rank sum test|||||||0.0232
72542668|NCT02191579|144615335|SUPERIORITY||Odds Ratio (OR)|4.94|||<|0.001|TWO_SIDED|95.0|2.681|9.085||Odds ratio, 95% CI, and p-value were estimated using a logistic regression model adjusted by baseline headache days.|Regression, Logistic|||||9.085|2.681|<0.001
72542669|NCT02191579|144615336|SUPERIORITY||Mean Difference (Net)|-6.199|||<|0.001|TWO_SIDED|95.0|-7.936|-4.462||Estimated mean difference, 95% CI, and p-value were assessed using analysis of covariance adjusting for baseline headache days.|ANCOVA|||||-4.462|-7.936|<0.001
72542670|NCT02191579|144615337|SUPERIORITY||Median Difference (Net)|-4.248|||<|0.001||95.0|-5.766|-2.731||Estimated mean difference, 95% CI, and p-value for Week 30 were assessed using analysis of covariance adjusting for baseline headache days.|ANCOVA|||||-2.731|-5.766|<0.001
72542671|NCT02191579|144615338|SUPERIORITY||Odds Ratio (OR)|4.05|||<|0.001||95.0|2.014|8.157||Odds ratio, 95% CI, and p-value for the Week 29-32 interval were estimated using a logistic regression model adjusted by baseline headache days.|Regression, Logistic|||||8.157|2.014|<0.001
72628319|NCT03950856|144784702|OTHER||Difference in Percentage|14.6|||<|0.001|TWO_SIDED|95.0|7.9|21.4|||Miettinen & Nurminen||V114 Combined Lots minus Prevnar 13™|Injection site pain: V114 Combined Lots - Prevnar 13™||21.4|7.9|<0.001
72628320|NCT03950856|144784702|OTHER||Difference in Percentage|1.0||||0.686|TWO_SIDED|95.0|-4.3|5.3|||Miettinen & Nurminen||V114 Combined Lots minus Prevnar 13™|Injection site swelling: V114 Combined Lots - Prevnar 13™||5.3|-4.3|0.686
72542672|NCT00769015|144615339|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.54||||0.067|TWO_SIDED|95.0|0.27|1.06||Mantel-Haenszel chi-square test. The p-value refers to the overall test of between group differences in rates of depression.|Mantel Haenszel|||||1.06|.27|.067
72329426|NCT02574078|144184362|SUPERIORITY||Hazard Ratio (HR)|0.42||||0.0544|TWO_SIDED|95.0|0.17|1.04|||Unstratified log-rank|||||1.04|0.17|0.0544
72542673|NCT00769015|144615340|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.81||||0.75|TWO_SIDED|95.0|-5.92|4.3|||Linear Mixed effects model|||||4.30|-5.92|.75
72542674|NCT00769015|144615341|SUPERIORITY_OR_OTHER||Change in least squares mean|3.47||||0.68|TWO_SIDED|95.0|-12.22|5.29|||Mixed Models Analysis|||||5.29|-12.22|.68
72542675|NCT00769015|144615342|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.42||||0.34|TWO_SIDED|95.0|-2.58|7.41|||Least squares mean|||||7.41|-2.58|.34
72542676|NCT00769015|144615343|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.02||||0.68|TWO_SIDED|95.0|-9.8|5.76|||Least squares mean|||||5.76|-9.80|.68
72542677|NCT00769015|144615344|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.39||||0.68|TWO_SIDED|95.0|-4.04|6.82|||Least squares mean|||||6.82|-4.04|.68
72542678|NCT00769015|144615345|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.62||||0.68|TWO_SIDED|95.0|-5.94|9.17|||Least squares mean|||||9.17|-5.94|.68
72542679|NCT04288115|144615453|NON_INFERIORITY|An one-sided α-level of 0.05 will be used to determine the statistical significance of the non-inferiority test.|Difference in Group Means|-5.3||||0.0913|TWO_SIDED|90.0|-16.1|5.4||Group differences.|Welch's two-sample t-test|A one-sided p-value \< 0.05 indicates the discontinuation mean falls within the non-inferiority limit.|Differences reported as the sham discontinuation mean minus the real discontinuation mean.|A one-sided t-test will be used to determine whether the mean Hypothyroid Symptoms score for the real discontinuation group is no more than 14 points worse than the score of the sham discontinuation group at 6 months.||5.4|-16.1|0.0913
72542680|NCT04288115|144615453|OTHER|A two-sided α-level of 0.05 will be used to determine the statistical difference.|Difference in Group Means|0.8||||0.8793|TWO_SIDED|95.0|-9.4|10.9||Testing whether group means are different.|ANCOVA|A p-value \< 0.05 indicates the real discontinuation mean and the sham discontinuation mean are different. Adjusted for gender and baseline HSSs.|Differences reported as the sham discontinuation mean minus the real discontinuation mean. These differences have been adjusted for gender and baseline hypothyroid symptom scores.|Analysis of 6-week outcome||10.9|-9.4|0.8793
72542681|NCT04288115|144615453|OTHER|A two-sided α-level of 0.05 will be used to determine the statistical significance.|Difference in Group Means|-2.3||||0.686|TWO_SIDED|95.0|-14.0|9.3||Group differences.|ANCOVA|A p-value \< 0.05 indicates real discontinuation mean and sham discontinuation mean are different. Analyses adjusted for gender and baseline HSS.|Differences are reported as sham discontinuation mean minus real discontinuation mean. These differences have been adjusted for gender and baseline hypothyroid symptom scores.|Analysis of 6-month outcome||9.3|-14.0|0.6860
72542682|NCT04288115|144615454|NON_INFERIORITY|A one-sided α-level of 0.05 will be used to determine the statistical significance of the non-inferiority test.|Difference in Group Means|5.2||||0.0036|TWO_SIDED|90.0|-6.2|16.6||Group differences.|Welch's two-sample t-test|A one-sided p-value \< 0.05 indicates the discontinuation mean falls within the non-inferiority limit.|Differences reported as the sham discontinuation mean minus the real discontinuation mean.|A one-sided t-test will be used to determine whether the mean Tiredness score for the real discontinuation group is no more than 14 points worse than the score of the sham discontinuation group at 6 months.||16.6|-6.2|0.0036
72628321|NCT03950856|144784704|OTHER||Difference in Percentage|2.0||||0.272|TWO_SIDED|95.0|-1.9|4.7|||Miettinen & Nurminen||V114 Combined Lots minus Prevnar 13™|Arthralgia: V114 Combined Lots - Prevnar 13™||4.7|-1.9|0.272
72628322|NCT03950856|144784704|OTHER||Difference in Percentage|-0.7||||0.812|TWO_SIDED|95.0|-6.7|4.5|||Miettinen & Nurminen||V114 Combined Lots minus Prevnar 13™|Fatigue: V114 Combined Lots - Prevnar 13™||4.5|-6.7|0.812
72628323|NCT03950856|144784704|OTHER||Difference in Percentage|0.2||||0.947|TWO_SIDED|95.0|-5.6|5.0|||Miettinen & Nurminen||V114 Combined Lots minus Prevnar 13™|Headache: V114 Combined Lots - Prevnar 13™||5.0|-5.6|0.947
72628324|NCT03950856|144784704|OTHER||Difference in Percentage|5.2||||0.091|TWO_SIDED|95.0|-0.9|10.4|||Miettinen & Nurminen||V114 Combined Lots minus Prevnar 13™|Myalgia: V114 Combined Lots - Prevnar 13™||10.4|-0.9|0.091
72628325|NCT03950856|144784706|OTHER||Miettinen & Nurminen|0.0|||||TWO_SIDED|95.0|-1.6|0.2|||||V114 Combined Lots minus Prevnar 13™|V114 Combined Lots - Prevnar 13™||0.2|-1.6|
72628326|NCT03950856|144784707|EQUIVALENCE|Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.|GMT Ratio|0.99|||<|0.001|TWO_SIDED|95.0|0.83|1.18||Identical p-values for the lower and upper bounds.|cLDA model|P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).|Lot 1 divided by Lot 2|Serotype 1: GMT Ratio V114 Lot 1 / V114 Lot 2|GMT ratio and 95% CI were estimated from a cLDA model.|1.18|0.83|<0.001
72628327|NCT03950856|144784707|EQUIVALENCE|Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.|GMT Ratio|1.04|||<|0.001|TWO_SIDED|95.0|0.87|1.24||Identical p-values for the lower and upper bounds.|cLDA model|P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).|Lot 1 divided by Lot 3|Serotype 1: GMT Ratio V114 Lot 1 / V114 Lot 3|GMT ratio and 95% CI were estimated from a cLDA model.|1.24|0.87|<0.001
72628328|NCT03950856|144784707|EQUIVALENCE|Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.|GMT Ratio|1.05|||<|0.001|TWO_SIDED|95.0|0.88|1.25||Identical p-values for the lower and upper bounds.|cLDA model|P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).|Lot 2 divided by Lot 3|Serotype 1: GMT Ratio V114 Lot 2 / V114 Lot 3|GMT ratio and 95% CI were estimated from a cLDA model.|1.25|0.88|<0.001
72628329|NCT03950856|144784707|EQUIVALENCE|Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.|GMT Ratio|0.85|||<|0.001|TWO_SIDED|95.0|0.75|0.97||Identical p-values for the lower and upper bounds.|cLDA model|P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).|Lot 1 divided by Lot 2|Serotype 3: GMT Ratio V114 Lot 1 / V114 Lot 2|GMT ratio and 95% CI were estimated from a cLDA model.|0.97|0.75|<0.001
72628330|NCT03950856|144784707|EQUIVALENCE|Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.|GMT Ratio|0.92|||<|0.001|TWO_SIDED|95.0|0.81|1.05||Identical p-values for the lower and upper bounds.|cLDA model|P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).|Lot 1 divided by Lot 3|Serotype 3: GMT Ratio V114 Lot 1 / V114 Lot 3|GMT ratio and 95% CI were estimated from a cLDA model.|1.05|0.81|<0.001
72628331|NCT03950856|144784707|EQUIVALENCE|Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.|GMT Ratio|1.08|||<|0.001|TWO_SIDED|95.0|0.95|1.23||Identical p-values for the lower and upper bounds.|cLDA model|P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).|Lot 2 divided by Lot 3|Serotype 3: GMT Ratio V114 Lot 2 / V114 Lot 3|GMT ratio and 95% CI were estimated from a cLDA model.|1.23|0.95|<0.001
72628332|NCT03950856|144784707|EQUIVALENCE|Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.|GMT Ratio|0.82|||<|0.001|TWO_SIDED|95.0|0.7|0.97||Identical p-values for the lower and upper bounds.|cLDA model|P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).|Lot 1 divided by Lot 2|Serotype 4: GMT Ratio V114 Lot 1 / V114 Lot 2|GMT ratio and 95% CI were estimated from a cLDA model.|0.97|0.70|<0.001
72628333|NCT03950856|144784707|EQUIVALENCE|Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.|GMT Ratio|1.0|||<|0.001|TWO_SIDED|95.0|0.85|1.18||Identical p-values for the lower and upper bounds.|cLDA model|P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).|Lot 1 divided by Lot 3|Serotype 4: GMT Ratio V114 Lot 1 / V114 Lot 3|GMT ratio and 95% CI were estimated from a cLDA model.|1.18|0.85|<0.001
72628334|NCT03950856|144784707|EQUIVALENCE|Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.|GMT Ratio|1.21|||<|0.001|TWO_SIDED|95.0|1.03|1.43||Identical p-values for the lower and upper bounds.|cLDA model|P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).|Lot 2 divided by Lot 3|Serotype 4: GMT Ratio V114 Lot 2 / V114 Lot 3|GMT ratio and 95% CI were estimated from a cLDA model.|1.43|1.03|<0.001
72628335|NCT03950856|144784707|EQUIVALENCE|Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.|GMT Ratio|0.84|||<|0.001|TWO_SIDED|95.0|0.7|1.02||Identical p-values for the lower and upper bounds.|cLDA model|P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).|Lot 1 divided by Lot 2|Serotype 5: GMT Ratio V114 Lot 1 / V114 Lot 2|GMT ratio and 95% CI were estimated from a cLDA model.|1.02|0.70|<0.001
72628336|NCT03950856|144784707|EQUIVALENCE|Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.|GMT Ratio|1.0|||<|0.001|TWO_SIDED|95.0|0.83|1.2||Identical p-values for the lower and upper bounds.|cLDA model|P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).|Lot 1 divided by Lot 3|Serotype 5: GMT Ratio V114 Lot 1 / V114 Lot 3|GMT ratio and 95% CI were estimated from a cLDA model.|1.20|0.83|<0.001
72628337|NCT03950856|144784707|EQUIVALENCE|Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.|GMT Ratio|1.18|||<|0.001|TWO_SIDED|95.0|0.98|1.42||Identical p-values for the lower and upper bounds.|cLDA model|P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).|Lot 2 divided by Lot 3|Serotype 5: GMT Ratio V114 Lot 2 / V114 Lot 3|GMT ratio and 95% CI were estimated from a cLDA model.|1.42|0.98|<0.001
72628338|NCT03950856|144784707|EQUIVALENCE|Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.|GMT Ratio|0.96|||<|0.001|TWO_SIDED|95.0|0.82|1.12||Identical p-values for the lower and upper bounds.|cLDA model|P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).|Lot 1 divided by Lot 2|Serotype 6A: GMT Ratio V114 Lot 1 / V114 Lot 2|GMT ratio and 95% CI were estimated from a cLDA model.|1.12|0.82|<0.001
72628339|NCT03950856|144784707|EQUIVALENCE|Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.|GMT Ratio|0.95|||<|0.001|TWO_SIDED|95.0|0.82|1.12||Identical p-values for the lower and upper bounds.|cLDA model|P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).|Lot 1 divided by Lot 3|Serotype 6A: GMT Ratio V114 Lot 1 / V114 Lot 3|GMT ratio and 95% CI were estimated from a cLDA model.|1.12|0.82|<0.001
72628340|NCT03950856|144784707|EQUIVALENCE|Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.|GMT Ratio|0.99|||<|0.001|TWO_SIDED|95.0|0.85|1.16||Identical p-values for the lower and upper bounds.|cLDA model|P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).|Lot 2 divided by Lot 3|Serotype 6A: GMT Ratio V114 Lot 2 / V114 Lot 3|GMT ratio and 95% CI were estimated from a cLDA model.|1.16|0.85|<0.001
72628341|NCT03950856|144784707|EQUIVALENCE|Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.|GMT Ratio|0.96|||<|0.001|TWO_SIDED|95.0|0.82|1.12||Identical p-values for the lower and upper bounds.|cLDA model|P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).|Lot 1 divided by Lot 2|Serotype 6B: GMT Ratio V114 Lot 1 / V114 Lot 2|GMT ratio and 95% CI were estimated from a cLDA model.|1.12|0.82|<0.001
72628342|NCT03950856|144784707|EQUIVALENCE|Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.|GMT Ratio|1.01|||<|0.001|TWO_SIDED|95.0|0.86|1.18||Identical p-values for the lower and upper bounds.|cLDA model|P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).|Lot 1 divided by Lot 3|Serotype 6B: GMT Ratio V114 Lot 1 / V114 Lot 3|GMT ratio and 95% CI were estimated from a cLDA model.|1.18|0.86|<0.001
72628343|NCT03950856|144784707|EQUIVALENCE|Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.|GMT Ratio|1.05|||<|0.001|TWO_SIDED|95.0|0.9|1.23||Identical p-values for the lower and upper bounds.|cLDA model|P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).|Lot 2 divided by Lot 3|Serotype 6B: GMT Ratio V114 Lot 2 / V114 Lot 3|GMT ratio and 95% CI were estimated from a cLDA model.|1.23|0.90|<0.001
72628344|NCT03950856|144784707|EQUIVALENCE|Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.|GMT Ratio|0.82|||<|0.001|TWO_SIDED|95.0|0.72|0.93||Identical p-values for the lower and upper bounds.|cLDA model|P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).|Lot 1 divided by Lot 2|Serotype 7F: GMT Ratio V114 Lot 1 / V114 Lot 2|GMT ratio and 95% CI were estimated from a cLDA model.|0.93|0.72|<0.001
72628345|NCT03950856|144784707|EQUIVALENCE|Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.|GMT Ratio|0.89|||<|0.001|TWO_SIDED|95.0|0.79|1.01||Identical p-values for the lower and upper bounds.|cLDA model|P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).|Lot 1 divided by Lot 3|Serotype 7F: GMT Ratio V114 Lot 1 / V114 Lot 3|GMT ratio and 95% CI were estimated from a cLDA model.|1.01|0.79|<0.001
72628346|NCT03950856|144784707|EQUIVALENCE|Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.|GMT Ratio|1.09|||<|0.001|TWO_SIDED|95.0|0.96|1.24||Identical p-values for the lower and upper bounds.|cLDA model|P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).|Lot 2 divided by Lot 3|Serotype 7F: GMT Ratio V114 Lot 2 / V114 Lot 3|GMT ratio and 95% CI were estimated from a cLDA model.|1.24|0.96|<0.001
72628347|NCT03950856|144784707|EQUIVALENCE|Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.|GMT Ratio|1.01|||<|0.001|TWO_SIDED|95.0|0.88|1.16||Identical p-values for the lower and upper bounds.|cLDA model|P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).|Lot 1 divided by Lot 2|Serotype 9V: GMT Ratio V114 Lot 1 / V114 Lot 2|GMT ratio and 95% CI were estimated from a cLDA model.|1.16|0.88|<0.001
72628348|NCT03950856|144784707|EQUIVALENCE|Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.|GMT Ratio|0.98|||<|0.001|TWO_SIDED|95.0|0.85|1.12||Identical p-values for the lower and upper bounds.|cLDA model|P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).|Lot 1 divided by Lot 3|Serotype 9V: GMT Ratio V114 Lot 1 / V114 Lot 3|GMT ratio and 95% CI were estimated from a cLDA model.|1.12|0.85|<0.001
72628349|NCT03950856|144784707|EQUIVALENCE|Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.|GMT Ratio|0.97|||<|0.001|TWO_SIDED|95.0|0.84|1.11||Identical p-values for the lower and upper bounds.|cLDA model|P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).|Lot 2 divided by Lot 3|Serotype 9V: GMT Ratio V114 Lot 2 / V114 Lot 3|GMT ratio and 95% CI were estimated from a cLDA model.|1.11|0.84|<0.001
72628350|NCT03950856|144784707|EQUIVALENCE|Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.|GMT Ratio|0.94|||<|0.001|TWO_SIDED|95.0|0.81|1.1||Identical p-values for the lower and upper bounds.|cLDA model|P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).|Lot 1 divided by Lot 2|Serotype 14: GMT Ratio V114 Lot 1 / V114 Lot 2|GMT ratio and 95% CI were estimated from a cLDA model.|1.10|0.81|<0.001
72628351|NCT03950856|144784707|EQUIVALENCE|Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.|GMT Ratio|1.15|||<|0.001|TWO_SIDED|95.0|0.99|1.34||Identical p-values for the lower and upper bounds.|cLDA model|P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).|Lot 1 divided by Lot 3|Serotype 14: GMT Ratio V114 Lot 1 / V114 Lot 3|GMT ratio and 95% CI were estimated from a cLDA model.|1.34|0.99|<0.001
72628352|NCT03950856|144784707|EQUIVALENCE|Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.|GMT Ratio|1.22|||<|0.001|TWO_SIDED|95.0|1.05|1.43||Identical p-values for the lower and upper bounds.|cLDA model|P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).|Lot 2 divided by Lot 3|Serotype 14: GMT Ratio V114 Lot 2 / V114 Lot 3|GMT ratio and 95% CI were estimated from a cLDA model.|1.43|1.05|<0.001
72410298|NCT01047683|144328931|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-15.3||||0.1152|TWO_SIDED|95.0|-30.3|-0.7|||Wilcoxon rank-sum test||Median differences between the treatment groups and 95% CIs were estimated with the Hodges-Lehmann method.|||-0.7|-30.3|0.1152
72410299|NCT01047683|144328932|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-13.6||||0.0006|TWO_SIDED|95.0|-20.2|-6.3||Nonparametric analysis p values were planned using Wilcoxon rank-sum test for each comparison between AMR101 and placebo. Comparisons between AMR101 and placebo were made using a significance level of 0.05.|Wilcoxon rank-sum test|A prespecified step-down testing procedure was used to control Type I error rate using 4 g/day vs placebo then, if significant, 2 g/day vs placebo.|Median differences between the treatment groups and 95% CIs were estimated with the Hodges-Lehmann method.|||-6.3|-20.2|0.0006
72410300|NCT01047683|144328932|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-5.1||||0.2367|TWO_SIDED|95.0|-12.3|2.2|||Wilcoxon rank-sum test||Median differences between the treatment groups and 95% CIs were estimated with the Hodges-Lehmann method.|||2.2|-12.3|0.2367
72410301|NCT01047683|144328933|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-8.5||||0.0019|TWO_SIDED|95.0|-13.5|-3.2||Nonparametric analysis p values were planned using Wilcoxon rank-sum test for each comparison between AMR101 and placebo. Comparisons between AMR101 and placebo were made using a significance level of 0.05.|Wilcoxon rank-sum test|A prespecified step-down testing procedure was used to control Type I error rate using 4 g/day vs placebo then, if significant, 2 g/day vs placebo.|Median differences between the treatment groups and 95% CIs were estimated with the Hodges-Lehmann method.|||-3.2|-13.5|0.0019
72410302|NCT01047683|144328933|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-2.6||||0.2367|TWO_SIDED|95.0|-7.8|1.9|||Wilcoxon rank-sum test||Median differences between the treatment groups and 95% CIs were estimated with the Hodges-Lehmann method.|||1.9|-7.8|0.2367
72410303|NCT01047683|144328934|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-2.3||||0.6768|TWO_SIDED|95.0|-12.9|8.1||Nonparametric analysis p values were planned using Wilcoxon rank-sum test for each comparison between AMR101 and placebo. Comparisons between AMR101 and placebo were made using a significance level of 0.05.|Wilcoxon rank-sum test|A prespecified step-down testing procedure was used to control Type I error rate using 4 g/day vs placebo then, if significant, 2 g/day vs placebo.|Median differences between the treatment groups and 95% CIs were estimated with the Hodges-Lehmann method.|||8.1|-12.9|0.6768
72410304|NCT01047683|144328934|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|5.2||||0.3022|TWO_SIDED|95.0|-5.4|15.6|||Wilcoxon rank-sum test||Median differences between the treatment groups and 95% CIs were estimated with the Hodges-Lehmann method.|||15.6|-5.4|0.3022
72410305|NCT01047683|144328935|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-17.7|||<|0.0001|TWO_SIDED|95.0|-25.0|-11.3||Nonparametric analysis p values were planned using Wilcoxon rank-sum test for each comparison between AMR101 and placebo. Comparisons between AMR101 and placebo were made using a significance level of 0.05.|Wilcoxon rank-sum test|A prespecified step-down testing procedure was used to control Type I error rate using 4 g/day vs placebo then, if significant, 2 g/day vs placebo.|Median differences between the treatment groups and 95% CIs were estimated with the Hodges-Lehmann method.|||-11.3|-25.0|<0.0001
72410306|NCT01047683|144328935|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-8.1||||0.0182|TWO_SIDED|95.0|-15.1|-1.4|||Wilcoxon rank-sum test||Median differences between the treatment groups and 95% CIs were estimated with the Hodges-Lehmann method.|||-1.4|-15.1|0.0182
72410307|NCT00908960|144328937|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|6.7||||0.06|TWO_SIDED|95.0|1.03|43.17|||Fine and Gray regression|||||43.17|1.03|0.06
72410308|NCT01260922|144328968|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|102.16|||||TWO_SIDED|90.0|97.07|107.51|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||107.51|97.07|
72410309|NCT01260922|144328969|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Slope|94.75|||||TWO_SIDED|90.0|92.11|97.46|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||97.46|92.11|
72628353|NCT03950856|144784707|EQUIVALENCE|Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.|GMT Ratio|1.1|||<|0.001|TWO_SIDED|95.0|0.96|1.26||Identical p-values for the lower and upper bounds.|cLDA model|P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).|Lot 1 divided by Lot 2|Serotype 18C: GMT Ratio V114 Lot 1 / V114 Lot 2|GMT ratio and 95% CI were estimated from a cLDA model.|1.26|0.96|<0.001
72410310|NCT04165291|144328971|SUPERIORITY||||||<|0.01|||||||ANOVA|||||||<.01
72410311|NCT04165291|144328972|OTHER|||||||0.08|||||||ANOVA|||||||.08
72410312|NCT04165291|144328973|SUPERIORITY|||||||0.116|||||||Repeated Measures Analysis of Variance|||||||.116
72410313|NCT04165291|144328974|SUPERIORITY||Mean Difference (Final Values)|5.146|||<|0.05|TWO_SIDED||||||Mixed Models Analysis|||||||<.05
72410314|NCT04165291|144328975|SUPERIORITY|||||||0.13|||||||ANOVA|||||||.13
72410315|NCT04165291|144328976|SUPERIORITY|||||||0.35|||||||ANOVA|||||||.35
72410316|NCT02248922|144328977|OTHER|||||||0.4099|||||||ANOVA|||||||0.4099
72410317|NCT02248922|144328978|OTHER|||||||0.6961|||||||ANOVA|||||||0.6961
72410318|NCT02248922|144328979|OTHER|||||||0.354|||||||ANOVA|||||||0.3540
72410319|NCT02248922|144328980|OTHER|||||||0.591|||||||ANOVA|||||||0.5910
72410320|NCT02248922|144328981|OTHER|||||||0.4249|||||||ANOVA|||||||0.4249
72410321|NCT02248922|144328982|OTHER|||||||0.3963|||||||ANOVA|||||||0.3963
72410322|NCT02248922|144328983|OTHER|||||||0.3502|||||||ANOVA|||||||0.3502
72421500|NCT01392300|144354184|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.09||0.884|TWO_SIDED|95.0|-0.2|0.2|||ANCOVA|||||0.2|-0.2|0.884
72628354|NCT03950856|144784707|EQUIVALENCE|Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.|GMT Ratio|1.15|||<|0.001|TWO_SIDED|95.0|1.0|1.31||Identical p-values for the lower and upper bounds.|cLDA model|P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).|Lot 1 divided by Lot 3|Serotype 18C: GMT Ratio V114 Lot 1 / V114 Lot 3|GMT ratio and 95% CI were estimated from a cLDA model.|1.31|1.00|<0.001
72628355|NCT03950856|144784707|EQUIVALENCE|Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.|GMT Ratio|1.04|||<|0.001|TWO_SIDED|95.0|0.91|1.19||Identical p-values for the lower and upper bounds.|cLDA model|P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).|Lot 2 divided by Lot 3|Serotype 18C: GMT Ratio V114 Lot 2 / V114 Lot 3|GMT ratio and 95% CI were estimated from a cLDA model.|1.19|0.91|<0.001
72628356|NCT03950856|144784707|EQUIVALENCE|Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.|GMT Ratio|0.9|||<|0.001|TWO_SIDED|95.0|0.79|1.02||Identical p-values for the lower and upper bounds.|cLDA model|P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).|Lot 1 divided by Lot 2|Serotype 19A: GMT Ratio V114 Lot 1 / V114 Lot 2|GMT ratio and 95% CI were estimated from a cLDA model.|1.02|0.79|<0.001
72628357|NCT03950856|144784707|EQUIVALENCE|Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.|GMT Ratio|0.97|||<|0.001|TWO_SIDED|95.0|0.85|1.1||Identical p-values for the lower and upper bounds.|cLDA model|P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).|Lot 1 divided by Lot 3|Serotype 19A: GMT Ratio V114 Lot 1 / V114 Lot 3|GMT ratio and 95% CI were estimated from a cLDA model.|1.10|0.85|<0.001
72628358|NCT03950856|144784707|EQUIVALENCE|Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.|GMT Ratio|1.08|||<|0.001|TWO_SIDED|95.0|0.95|1.22||Identical p-values for the lower and upper bounds.|cLDA model|P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).|Lot 2 divided by Lot 3|Serotype 19A: GMT Ratio V114 Lot 2 / V114 Lot 3|GMT ratio and 95% CI were estimated from a cLDA model.|1.22|0.95|<0.001
72628359|NCT03950856|144784707|EQUIVALENCE|Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.|GMT Ratio|0.92|||<|0.001|TWO_SIDED|95.0|0.81|1.05||Identical p-values for the lower and upper bounds.|cLDA model|P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).|Lot 1 divided by Lot 2|Serotype 19F: GMT Ratio V114 Lot 1 / V114 Lot 2|GMT ratio and 95% CI were estimated from a cLDA model.|1.05|0.81|<0.001
72628360|NCT03950856|144784707|EQUIVALENCE|Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.|GMT Ratio|0.94|||<|0.001|TWO_SIDED|95.0|0.82|1.07||Identical p-values for the lower and upper bounds.|cLDA model|P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).|Lot 1 divided by Lot 3|Serotype 19F: GMT Ratio V114 Lot 1 / V114 Lot 3|GMT ratio and 95% CI were estimated from a cLDA model.|1.07|0.82|<0.001
72628361|NCT03950856|144784707|EQUIVALENCE|Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.|GMT Ratio|1.01|||<|0.001|TWO_SIDED|95.0|0.89|1.15||Identical p-values for the lower and upper bounds.|cLDA model|P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).|Lot 2 divided by Lot 3|Serotype 19F: GMT Ratio V114 Lot 2 / V114 Lot 3|GMT ratio and 95% CI were estimated from a cLDA model.|1.15|0.89|<0.001
72628362|NCT03950856|144784707|EQUIVALENCE|Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.|GMT Ratio|0.92|||<|0.001|TWO_SIDED|95.0|0.77|1.1||Identical p-values for the lower and upper bounds.|cLDA model|P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).|Lot 1 divided by Lot 2|Serotype 23F: GMT Ratio V114 Lot 1 / V114 Lot 2|GMT ratio and 95% CI were estimated from a cLDA model.|1.10|0.77|<0.001
72628363|NCT03950856|144784707|EQUIVALENCE|Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.|GMT Ratio|1.04|||<|0.001|TWO_SIDED|95.0|0.87|1.24||Identical p-values for the lower and upper bounds.|cLDA model|P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).|Lot 1 divided by Lot 3|Serotype 23F: GMT Ratio V114 Lot 1 / V114 Lot 3|GMT ratio and 95% CI were estimated from a cLDA model.|1.24|0.87|<0.001
72628364|NCT03950856|144784707|EQUIVALENCE|Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.|GMT Ratio|1.13|||<|0.001|TWO_SIDED|95.0|0.95|1.35||Identical p-values for the lower and upper bounds.|cLDA model|P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).|Lot 2 divided by Lot 3|Serotype 23F: GMT Ratio V114 Lot 2 / V114 Lot 3|GMT ratio and 95% CI were estimated from a cLDA model.|1.35|0.95|<0.001
72628365|NCT03950856|144784707|EQUIVALENCE|Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.|GMT Ratio|0.95|||<|0.001|TWO_SIDED|95.0|0.81|1.11||Identical p-values for the lower and upper bounds.|cLDA model|P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).|Lot 1 divided by Lot 2|Serotype 22F: GMT Ratio V114 Lot 1 / V114 Lot 2|GMT ratio and 95% CI were estimated from a cLDA model.|1.11|0.81|<0.001
72628366|NCT03950856|144784707|EQUIVALENCE|Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.|GMT Ratio|0.98|||<|0.001|TWO_SIDED|95.0|0.84|1.14||Identical p-values for the lower and upper bounds.|cLDA model|P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).|Lot 1 divided by Lot 3|Serotype 22F: GMT Ratio V114 Lot 1 / V114 Lot 3|GMT ratio and 95% CI were estimated from a cLDA model.|1.14|0.84|<0.001
72628367|NCT03950856|144784707|EQUIVALENCE|Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.|GMT Ratio|1.03|||<|0.001|TWO_SIDED|95.0|0.88|1.21||Identical p-values for the lower and upper bounds.|cLDA model|P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).|Lot 2 divided by Lot 3|Serotype 22F: GMT Ratio V114 Lot 2 / V114 Lot 3|GMT ratio and 95% CI were estimated from a cLDA model.|1.21|0.88|<0.001
72628368|NCT03950856|144784707|EQUIVALENCE|Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.|GMT Ratio|1.0|||<|0.001|TWO_SIDED|95.0|0.86|1.16||Identical p-values for the lower and upper bounds.|cLDA model|P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).|Lot 1 divided by Lot 2|Serotype 33F: GMT Ratio V114 Lot 1 / V114 Lot 2|GMT ratio and 95% CI were estimated from a cLDA model.|1.16|0.86|<0.001
72628369|NCT03950856|144784707|EQUIVALENCE|Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.|GMT Ratio|1.05|||<|0.001|TWO_SIDED|95.0|0.91|1.22||Identical p-values for the lower and upper bounds.|cLDA model|P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).|Lot 1 divided by Lot 3|Serotype 33F: GMT Ratio V114 Lot 1 / V114 Lot 3|GMT ratio and 95% CI were estimated from a cLDA model.|1.22|0.91|<0.001
72628370|NCT03950856|144784707|EQUIVALENCE|Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.|GMT Ratio|1.05|||<|0.001|TWO_SIDED|95.0|0.9|1.22||Identical p-values for the lower and upper bounds.|cLDA model|P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).|Lot 2 divided by Lot 3|Serotype 33F: GMT Ratio V114 Lot 2 / V114 Lot 3|GMT ratio and 95% CI were estimated from a cLDA model.|1.22|0.90|<0.001
72628371|NCT03950856|144784708|OTHER||GMC Ratio|0.96|||||TWO_SIDED|95.0|0.84|1.1|||||Lot 1 divided by Lot 2|Serotype 1: GMC Ratio V114 Lot 1 / V114 Lot 2|GMC ratio and 95% CI were estimated from a cLDA model.|1.10|0.84|
72628372|NCT03950856|144784708|OTHER||GMC Ratio|1.02|||||TWO_SIDED|95.0|0.89|1.17|||||Lot 1 divided by Lot 3|Serotype 1: GMC Ratio V114 Lot 1 / V114 Lot 3|GMC ratio and 95% CI were estimated from a cLDA model.|1.17|0.89|
72628373|NCT03950856|144784708|OTHER||GMC Ratio|1.06|||||TWO_SIDED|95.0|0.92|1.21|||||Lot 2 divided by Lot 3|Serotype 1: GMC Ratio V114 Lot 2 / V114 Lot 3|GMC ratio and 95% CI were estimated from a cLDA model.|1.21|0.92|
72628374|NCT03950856|144784708|OTHER||GMC Ratio|0.85|||||TWO_SIDED|95.0|0.77|0.95|||||Lot 1 divided by Lot 2|Serotype 3: GMC Ratio V114 Lot 1 / V114 Lot 2|GMC ratio and 95% CI were estimated from a cLDA model.|0.95|0.77|
72628375|NCT03950856|144784708|OTHER||GMC Ratio|1.01|||||TWO_SIDED|95.0|0.91|1.13|||||Lot 1 divided by Lot 3|Serotype 3: GMC Ratio V114 Lot 1 / V114 Lot 3|GMC ratio and 95% CI were estimated from a cLDA model.|1.13|0.91|
72410323|NCT01312961|144329029|SUPERIORITY||Odds Ratio (OR)|0.077|||<|0.0001|TWO_SIDED|95.0|0.021|0.28||Threshold for significance at 0.05 level.|Regression, Logistic||Dupilumab 300 mg vs. Placebo|Analysis was performed using a logistic regression model with treatment groups and stratification factor (prior ICS/LABA combination therapy dose) as covariates.||0.280|0.021|<0.0001
72628376|NCT03950856|144784708|OTHER||GMC Ratio|1.18|||||TWO_SIDED|95.0|1.06|1.32|||||Lot 2 divided by Lot 3|Serotype 3: GMC Ratio V114 Lot 2 / V114 Lot 3|GMC ratio and 95% CI were estimated from a cLDA model.|1.32|1.06|
72628377|NCT03950856|144784708|OTHER||GMC Ratio|0.82|||||TWO_SIDED|95.0|0.72|0.94|||||Lot 1 divided by Lot 2|Serotype 4: GMC Ratio V114 Lot 1 / V114 Lot 2|GMC ratio and 95% CI were estimated from a cLDA model.|0.94|0.72|
72628378|NCT03950856|144784708|OTHER||GMC Ratio|1.07|||||TWO_SIDED|95.0|0.94|1.23|||||Lot 1 divided by Lot 3|Serotype 4: GMC Ratio V114 Lot 1 / V114 Lot 3|GMC ratio and 95% CI were estimated from a cLDA model.|1.23|0.94|
72628379|NCT03950856|144784708|OTHER||GMC Ratio|1.31|||||TWO_SIDED|95.0|1.14|1.5||||P-value for the comparison of the GMT ratio to the upper bound (2.0).|Lot 2 divided by Lot 3|Serotype 4: GMC Ratio V114 Lot 2 / V114 Lot 3|GMC ratio and 95% CI were estimated from a cLDA model.|1.50|1.14|
72628380|NCT03950856|144784708|OTHER||GMC Ratio|0.82|||||TWO_SIDED|95.0|0.72|0.95|||||Lot 1 divided by Lot 2|Serotype 5: GMC Ratio V114 Lot 1 / V114 Lot 2|GMC ratio and 95% CI were estimated from a cLDA model.|0.95|0.72|
72628381|NCT03950856|144784708|OTHER||GMC Ratio|0.96|||||TWO_SIDED|95.0|0.84|1.11|||||Lot 1 divided by Lot 3|Serotype 5: GMC Ratio V114 Lot 1 / V114 Lot 3|GMC ratio and 95% CI were estimated from a cLDA model.|1.11|0.84|
72628382|NCT03950856|144784708|OTHER||GMC Ratio|1.17|||||TWO_SIDED|95.0|1.02|1.35|||||Lot 2 divided by Lot 3|Serotype 5: GMC Ratio V114 Lot 2 / V114 Lot 3|GMC ratio and 95% CI were estimated from a cLDA model.|1.35|1.02|
72628383|NCT03950856|144784708|OTHER||GMC Ratio|0.92|||||TWO_SIDED|95.0|0.78|1.07|||||Lot 1 divided by Lot 2|Serotype 6A: GMC Ratio V114 Lot 1 / V114 Lot 2|GMC ratio and 95% CI were estimated from a cLDA model.|1.07|0.78|
72628384|NCT03950856|144784708|OTHER||GMC Ratio|0.99|||||TWO_SIDED|95.0|0.85|1.16|||||Lot 1 divided by Lot 3|Serotype 6A: GMC Ratio V114 Lot 1 / V114 Lot 3|GMC ratio and 95% CI were estimated from a cLDA model.|1.16|0.85|
72421501|NCT01392300|144354185|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.1||0.844|TWO_SIDED|95.0|-0.2|0.2|||ANCOVA|||||0.2|-0.2|0.844
72628385|NCT03950856|144784708|OTHER||GMC Ratio|1.08|||||TWO_SIDED|95.0|0.93|1.27|||||Lot 2 divided by Lot 3|Serotype 6A: GMC Ratio V114 Lot 2 / V114 Lot 3|GMC ratio and 95% CI were estimated from a cLDA model.|1.27|0.93|
72628386|NCT03950856|144784708|OTHER||GMC Ratio|0.95|||||TWO_SIDED|95.0|0.82|1.11|||||Lot 1 divided by Lot 2|Serotype 6B: GMC Ratio V114 Lot 1 / V114 Lot 2|GMC ratio and 95% CI were estimated from a cLDA model.|1.11|0.82|
72628387|NCT03950856|144784708|OTHER||GMC Ratio|1.05|||||TWO_SIDED|95.0|0.9|1.22|||||Lot 1 divided by Lot 3|Serotype 6B: GMC Ratio V114 Lot 1 / V114 Lot 3|GMC ratio and 95% CI were estimated from a cLDA model.|1.22|0.90|
72628388|NCT03950856|144784708|OTHER||GMC Ratio|1.1|||||TWO_SIDED|95.0|0.94|1.28|||||Lot 2 divided by Lot 3|Serotype 6B: GMC Ratio V114 Lot 2 / V114 Lot 3|GMC ratio and 95% CI were estimated from a cLDA model.|1.28|0.94|
72628389|NCT03950856|144784708|OTHER||GMC Ratio|0.8|||||TWO_SIDED|95.0|0.7|0.92|||||Lot 1 divided by Lot 2|Serotype 7F: GMC Ratio V114 Lot 1 / V114 Lot 2|GMC ratio and 95% CI were estimated from a cLDA model.|0.92|0.70|
72628390|NCT03950856|144784708|OTHER||GMC Ratio|0.96|||||TWO_SIDED|95.0|0.84|1.1|||||Lot 1 divided by Lot 3|Serotype 7F: GMC Ratio V114 Lot 1 / V114 Lot 3|GMC ratio and 95% CI were estimated from a cLDA model.|1.10|0.84|
72628391|NCT03950856|144784708|OTHER||GMC Ratio|1.2|||||TWO_SIDED|95.0|1.04|1.37|||||Lot 2 divided by Lot 3|Serotype 7F: GMC Ratio V114 Lot 2 / V114 Lot 3|GMC ratio and 95% CI were estimated from a cLDA model.|1.37|1.04|
72628392|NCT03950856|144784708|OTHER||GMC Ratio|0.95|||||TWO_SIDED|95.0|0.83|1.08|||l||Lot 1 divided by Lot 2|Serotype 9V: GMC Ratio V114 Lot 1 / V114 Lot 2|GMC ratio and 95% CI were estimated from a cLDA model.|1.08|0.83|
72628393|NCT03950856|144784708|OTHER||GMC Ratio|0.99|||||TWO_SIDED|95.0|0.87|1.13|||||Lot 1 divided by Lot 3|Serotype 9V: GMC Ratio V114 Lot 1 / V114 Lot 3|GMC ratio and 95% CI were estimated from a cLDA model.|1.13|0.87|
72628394|NCT03950856|144784708|OTHER||GMC Ratio|1.04|||||TWO_SIDED|95.0|0.91|1.19|||||Lot 2 divided by Lot 3|Serotype 9V: GMC Ratio V114 Lot 2 / V114 Lot 3|GMC ratio and 95% CI were estimated from a cLDA model.|1.19|0.91|
72628395|NCT03950856|144784708|OTHER||GMC Ratio|0.86|||||TWO_SIDED|95.0|0.75|1.0|||||Lot 1 divided by Lot 2|Serotype 14: GMC Ratio V114 Lot 1 / V114 Lot 2|GMC ratio and 95% CI were estimated from a cLDA model.|1.00|0.75|
72628396|NCT03950856|144784708|OTHER||GMC Ratio|1.13|||||TWO_SIDED|95.0|0.98|1.31|||||Lot 1 divided by Lot 3|Serotype 14: GMC Ratio V114 Lot 1 / V114 Lot 3|GMC ratio and 95% CI were estimated from a cLDA model.|1.31|0.98|
72628397|NCT03950856|144784708|OTHER||GMC Ratio|1.31|||||TWO_SIDED|95.0|1.14|1.52|||||Lot 2 divided by Lot 3|Serotype 14: GMC Ratio V114 Lot 2 / V114 Lot 3|GMC ratio and 95% CI were estimated from a cLDA model.|1.52|1.14|
72628398|NCT03950856|144784708|OTHER||GMC Ratio|1.19|||||TWO_SIDED|95.0|1.04|1.36|||||Lot 1 divided by Lot 2|Serotype 18C: GMC Ratio V114 Lot 1 / V114 Lot 2|GMC ratio and 95% CI were estimated from a cLDA model.|1.36|1.04|
72628399|NCT03950856|144784708|OTHER||GMC Ratio|1.32|||||TWO_SIDED|95.0|1.15|1.51|||||Lot 1 divided by Lot 3|Serotype 18C: GMC Ratio V114 Lot 1 / V114 Lot 3|GMC ratio and 95% CI were estimated from a cLDA model.|1.51|1.15|
72628400|NCT03950856|144784708|OTHER||GMC Ratio|1.11|||||TWO_SIDED|95.0|0.97|1.27|||||Lot 2 divided by Lot 3|Serotype 18C: GMC Ratio V114 Lot 2 / V114 Lot 3|GMC ratio and 95% CI were estimated from a cLDA model.|1.27|0.97|
72628401|NCT03950856|144784708|OTHER||GMC Ratio|0.89|||||TWO_SIDED|95.0|0.78|1.02|||||Lot 1 divided by Lot 2|Serotype 19A: GMC Ratio V114 Lot 1 / V114 Lot 2|GMC ratio and 95% CI were estimated from a cLDA model.|1.02|0.78|
72628402|NCT03950856|144784708|OTHER||GMC Ratio|0.98|||||TWO_SIDED|95.0|0.86|1.11|||||Lot 1 divided by Lot 3|Serotype 19A: GMC Ratio V114 Lot 1 / V114 Lot 3|GMC ratio and 95% CI were estimated from a cLDA model.|1.11|0.86|
72628403|NCT03950856|144784708|OTHER||GMC Ratio|1.1|||||TWO_SIDED|95.0|0.96|1.25|||||Lot 2 divided by Lot 3|Serotype 19A: GMC Ratio V114 Lot 2 / V114 Lot 3|GMC ratio and 95% CI were estimated from a cLDA model.|1.25|0.96|
72628404|NCT03950856|144784708|OTHER||GMC Ratio|0.87|||||TWO_SIDED|95.0|0.76|1.0|||||Lot 1 divided by Lot 2|Serotype 19F: GMC Ratio V114 Lot 1 / V114 Lot 2|GMC ratio and 95% CI were estimated from a cLDA model.|1.00|0.76|
72628405|NCT03950856|144784708|OTHER||GMC Ratio|0.92|||||TWO_SIDED|95.0|0.8|1.05|||||Lot 1 divided by Lot 3|Serotype 19F: GMC Ratio V114 Lot 1 / V114 Lot 3|GMC ratio and 95% CI were estimated from a cLDA model.|1.05|0.80|
72628406|NCT03950856|144784708|OTHER||GMC Ratio|1.05|||||TWO_SIDED|95.0|0.92|1.21|||||Lot 2 divided by Lot 3|Serotype 19F: GMC Ratio V114 Lot 2 / V114 Lot 3|GMC ratio and 95% CI were estimated from a cLDA model.|1.21|0.92|
72628407|NCT03950856|144784708|OTHER||GMC Ratio|0.93|||||TWO_SIDED|95.0|0.8|1.07|||||Lot 1 divided by Lot 2|Serotype 23F: GMC Ratio V114 Lot 1 / V114 Lot 2|GMC ratio and 95% CI were estimated from a cLDA model.|1.07|0.80|
72628408|NCT03950856|144784708|OTHER||GMC Ratio|0.99|||||TWO_SIDED|95.0|0.86|1.15|||||Lot 1 divided by Lot 3|Serotype 23F: GMC Ratio V114 Lot 1 / V114 Lot 3|GMC ratio and 95% CI were estimated from a cLDA model.|1.15|0.86|
72628409|NCT03950856|144784708|OTHER||GMC Ratio|1.07|||||TWO_SIDED|95.0|0.93|1.24|||||Lot 2 divided by Lot 3|Serotype 23F: GMC Ratio V114 Lot 2 / V114 Lot 3|GMC ratio and 95% CI were estimated from a cLDA model.|1.24|0.93|
72628410|NCT03950856|144784708|OTHER||GMC Ratio|0.93|||||TWO_SIDED|95.0|0.81|1.08|||||Lot 1 divided by Lot 2|Serotype 22F: GMC Ratio V114 Lot 1 / V114 Lot 2|GMC ratio and 95% CI were estimated from a cLDA model.|1.08|0.81|
72628411|NCT03950856|144784708|OTHER||GMC Ratio|1.08|||||TWO_SIDED|95.0|0.93|1.26|||||Lot 1 divided by Lot 3|Serotype 22F: GMC Ratio V114 Lot 1 / V114 Lot 3|GMC ratio and 95% CI were estimated from a cLDA model.|1.26|0.93|
72628412|NCT03950856|144784708|OTHER||GMC Ratio|1.16|||||TWO_SIDED|95.0|1.0|1.35|||||Lot 2 divided by Lot 3|Serotype 22F: GMC Ratio V114 Lot 2 / V114 Lot 3|GMC ratio and 95% CI were estimated from a cLDA model.|1.35|1.00|
72628413|NCT03950856|144784708|OTHER||GMC Ratio|0.91|||||TWO_SIDED|95.0|0.79|1.06|||||Lot 1 divided by Lot 2|Serotype 33F: GMC Ratio V114 Lot 1 / V114 Lot 2|GMC ratio and 95% CI were estimated from a cLDA model.|1.06|0.79|
72628414|NCT03950856|144784708|OTHER||GMC Ratio|1.05|||||TWO_SIDED|95.0|0.9|1.22|||||Lot 1 divided by Lot 3|Serotype 33F: GMC Ratio V114 Lot 1 / V114 Lot 3|GMC ratio and 95% CI were estimated from a cLDA model.|1.22|0.90|
72628415|NCT03950856|144784708|OTHER||GMC Ratio|1.15|||||TWO_SIDED|95.0|0.99|1.34|||||Lot 2 divided by Lot 3|Serotype 33F: GMC Ratio V114 Lot 2 / V114 Lot 3|GMC ratio and 95% CI were estimated from a cLDA model.|1.34|0.99|
72628416|NCT03950856|144784709|OTHER||GMC Ratio|0.75|||||TWO_SIDED|95.0|0.62|0.91|||||V114 Combined Lots divided by Prevnar 13™|Serotype 1: GMC Ratio V114 Combined Lots / Prevnar 13™|GMC ratio and 95% CI were estimated from a cLDA model.|0.91|0.62|
72628417|NCT03950856|144784709|OTHER||GMC Ratio|1.39|||||TWO_SIDED|95.0|1.2|1.61|||||V114 Combined Lots divided by Prevnar 13™|Serotype 3: GMC Ratio V114 Combined Lots / Prevnar 13™|GMC ratio and 95% CI were estimated from a cLDA model.|1.61|1.20|
72628418|NCT03950856|144784709|OTHER||GMC Ratio|0.79|||||TWO_SIDED|95.0|0.66|0.94|||||V114 Combined Lots divided by Prevnar 13™|Serotype 4: GMC Ratio V114 Combined Lots / Prevnar 13™|GMC ratio and 95% CI were estimated from a cLDA model.|0.94|0.66|
72628419|NCT03950856|144784709|OTHER||GMC Ratio|0.89|||||TWO_SIDED|95.0|0.74|1.07|||||V114 Combined Lots divided by Prevnar 13™|Serotype 5: GMC Ratio V114 Combined Lots / Prevnar 13™|GMC ratio and 95% CI were estimated from a cLDA model.|1.07|0.74|
72628420|NCT03950856|144784709|OTHER||GMC Ratio|1.16|||||TWO_SIDED|95.0|0.95|1.43|||||V114 Combined Lots divided by Prevnar 13™|Serotype 6A: GMC Ratio V114 Combined Lots / Prevnar 13™|GMC ratio and 95% CI were estimated from a cLDA model.|1.43|0.95|
72628421|NCT03950856|144784709|OTHER||GMC Ratio|1.5|||||TWO_SIDED|95.0|1.21|1.86|||||V114 Combined Lots divided by Prevnar 13™|Serotype 6B: GMC Ratio V114 Combined Lots / Prevnar 13™|GMC ratio and 95% CI were estimated from a cLDA model.|1.86|1.21|
72628422|NCT03950856|144784709|OTHER||GMC Ratio|0.87|||||TWO_SIDED|95.0|0.73|1.04|||||V114 Combined Lots divided by Prevnar 13™|Serotype 7F: GMC Ratio V114 Combined Lots / Prevnar 13™|GMC ratio and 95% CI were estimated from a cLDA model.|1.04|0.73|
72628423|NCT03950856|144784709|OTHER||GMC Ratio|0.87|||||TWO_SIDED|95.0|0.72|1.04|||||V114 Combined Lots divided by Prevnar 13™|Serotype 9V: GMC Ratio V114 Combined Lots / Prevnar 13™|GMC ratio and 95% CI were estimated from a cLDA model.|1.04|0.72|
72628424|NCT03950856|144784709|OTHER||GMC Ratio|0.99|||||TWO_SIDED|95.0|0.82|1.2|||||V114 Combined Lots divided by Prevnar 13™|Serotype 14: GMC Ratio V114 Combined Lots / Prevnar 13™|GMC ratio and 95% CI were estimated from a cLDA model.|1.20|0.82|
72329427|NCT02574078|144184362|SUPERIORITY||Hazard Ratio (HR)|2.04||||0.0442|TWO_SIDED|95.0|1.0|4.16|||Unstratified log-rank|||||4.16|1.00|0.0442
72628425|NCT03950856|144784709|OTHER||GMC Ratio|1.26|||||TWO_SIDED|95.0|1.05|1.51|||||V114 Combined Lots divided by Prevnar 13™|Serotype 18C: GMC Ratio V114 Combined Lots / Prevnar 13™|GMC ratio and 95% CI were estimated from a cLDA model.|1.51|1.05|
72628426|NCT03950856|144784709|OTHER||GMC Ratio|0.97|||||TWO_SIDED|95.0|0.82|1.15|||||V114 Combined Lots divided by Prevnar 13™|Serotype 19A: GMC Ratio V114 Combined Lots / Prevnar 13™|GMC ratio and 95% CI were estimated from a cLDA model.|1.15|0.82|
72628427|NCT03950856|144784709|OTHER||GMC Ratio|1.03|||||TWO_SIDED|95.0|0.86|1.23|||||V114 Combined Lots divided by Prevnar 13™|Serotype 19F: GMC Ratio V114 Combined Lots / Prevnar 13™|GMC ratio and 95% CI were estimated from a cLDA model.|1.23|0.86|
72577180|NCT04414345|144680919|SUPERIORITY||Mean Difference (Net)|-3.1|STANDARD_ERROR_OF_MEAN|3.403||0.3621|TWO_SIDED|95.0|-9.78|3.58|||Mixed Models Analysis|Covariates include baseline use of edaravone and riluzole, months since symptom onset, and pre-baseline ALSFRS-R slope.|CNM-Au8 24-week change from baseline relative to placebo 24-week change from baseline.|||3.58|-9.78|0.3621
72577181|NCT04414345|144680920|SUPERIORITY|||||||0.7398|||||||Log Rank|||||||0.7398
72577182|NCT02052011|144680926|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.27|||||TWO_SIDED|95.0|-0.08|0.62||||||||0.62|-0.08|
72577183|NCT00000620|144680927|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.91||||0.12|TWO_SIDED|95.0|0.81|1.03||P-value presented is not adjusted for multiple comparisons. A priori significance level was 0.05.|Regression, Cox|||Adjustment performed for the following pre-specified factors: sub-trial assignment (Blood Pressure Trial or Lipid Trial), assignment to intensive BP group in BP Trial, assignment to fenofibrate group in Lipid Trial, the seven clinical center networks, and presence of clinical cardiovascular disease at baseline.||1.03|0.81|0.12
72577184|NCT00000620|144680928|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.19||||0.02|TWO_SIDED|95.0|1.03|1.38||P-value presented is not adjusted for multiple comparisons. A priori significance level was 0.05.|Regression, Cox|||Adjustment performed for the following pre-specified factors: sub-trial assignment (Blood Pressure Trial or Lipid Trial), assignment to intensive BP group in BP Trial, assignment to fenofibrate group in Lipid Trial, the seven clinical center networks, and presence of clinical cardiovascular disease at baseline.||1.38|1.03|0.02
72577185|NCT00000620|144680929|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.88||||0.2|TWO_SIDED|95.0|0.73|1.06||P-value is adjusted for interim monitoring. A priori significance level was 0.05.|Regression, Cox|Adjustment for the seven clinical center networks and presence of clinical cardiovascular disease at baseline as pre-specified in the study protocol.||Recruitment for the Blood PressureTrial was designed to enroll 4200 participant to have 94% power to detect a 20% reduction in the rate of MCE for patients in the intensive-therapy group as compared with the standard-therapy group, assuming a two-sided alpha level of 0.05, a primary-outcome rate of 4% per year in the standard-therapy group, and a planned average follow-up of approximately 5.6 years.||1.06|0.73|0.20
72577186|NCT00000620|144680930|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.59||||0.01|TWO_SIDED|95.0|0.39|0.89||P-value presented is not adjusted for multiple comparisons. A priori significance level was 0.05.|Regression, Cox|Adjustment for the seven clinical center networks and presence of clinical cardiovascular disease at baseline as pre-specified in the study protocol.||||0.89|0.39|0.01
72577187|NCT00000620|144680931|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.92||||0.32|TWO_SIDED|95.0|0.79|1.08||P-value is adjusted for interim monitoring. A priori significance level was 0.05.|Regression, Cox|Adjustment for the seven clinical center networks and presence of clinical cardiovascular disease at baseline as pre-specified in the study protocol.||Recruitment for the Glycemia Trial was designed to enroll 5800 participant to have 87% power to detect a 20% reduction in the rate of MCE for patients in the fenofibrate group as compared with the placebo group, assuming a two-sided alpha level of 0.05, a primary-outcome rate of 2.4% per year in the placebo group, and a planned average follow-up of approximately 5.6 years.||1.08|0.79|0.32
72577188|NCT00000620|144680932|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.94||||0.3|TWO_SIDED|95.0|0.85|1.05||P-value presented is not adjusted for multiple comparisons. A priori significance level was 0.05.|Regression, Cox|Adjustment for the seven clinical center networks and presence of clinical cardiovascular disease at baseline as pre-specified in the study protocol.||||1.05|0.85|0.30
72577189|NCT02960490|144680936|SUPERIORITY||Difference from Placebo|-4.7||||0.621|TWO_SIDED|95.0|-25.85|16.46|||Regression, Logistic|||||16.46|-25.85|0.621
72577190|NCT02952586|144680982|SUPERIORITY||Hazard Ratio (HR)|1.21||||0.9199|TWO_SIDED|95.0|0.928|1.573||The treatment arms were compared using a stratified, 1-sided, log rank Test. The three stratification factors were tumor (T) stage (\< T4 vs T4), Nodal (N) stage (N0 /N1/N2a/N2b vs N2c/N3), Human papillomavirus (HPV) status (Positive vs Negative).|Log Rank|||||1.573|0.928|0.9199
72577191|NCT02952586|144680983|SUPERIORITY||Hazard Ratio (HR)|1.31||||0.9372|TWO_SIDED|95.0|0.927|1.849||The treatment arms were compared using a stratified, 1-sided, log rank Test. The three stratification factors were tumor (T) stage (\< T4 vs T4), Nodal (N) stage (N0 /N1/N2a/N2b vs N2c/N3), Human papillomavirus (HPV) status (Positive vs Negative).|Log Rank|||||1.849|0.927|0.9372
72577192|NCT02952586|144680985|SUPERIORITY||Hazard Ratio (HR)|1.25||||0.9316|TWO_SIDED|95.0|0.93|1.694||The treatment arms were compared using a stratified, 1-sided, log rank Test. The three stratification factors were tumor (T) stage (\< T4 vs T4), Nodal (N) stage (N0 /N1/N2a/N2b vs N2c/N3), Human papillomavirus (HPV) status (Positive vs Negative).|Log Rank|||||1.694|0.930|0.9316
72577193|NCT02952586|144680986|SUPERIORITY||Odds Ratio (OR)|0.947||||0.6229|TWO_SIDED|95.0|0.663|1.352||The treatment arms were compared using a stratified, 1-sided, Cochran-Mantel-Haenszel Test. The 3 stratification factors were tumor stage (\< T4 vs T4), Nodal stage (N0 /N1/N2a/N2b vs N2c/N3), HPV status (Positive vs Negative).|Cochran-Mantel-Haenszel|||||1.352|0.663|0.6229
72628428|NCT03950856|144784709|OTHER||GMC Ratio|1.26|||||TWO_SIDED|95.0|1.03|1.54|||||V114 Combined Lots divided by Prevnar 13™|Serotype 23F: GMC Ratio V114 Combined Lots / Prevnar 13™|GMC ratio and 95% CI were estimated from a cLDA model.|1.54|1.03|
72628429|NCT03950856|144784709|OTHER||GMC Ratio|12.21|||||TWO_SIDED|95.0|10.11|14.74|||||V114 Combined Lots divided by Prevnar 13™|Serotype 22F: GMC Ratio V114 Combined Lots / Prevnar 13™|GMC ratio and 95% CI were estimated from a cLDA model.|14.74|10.11|
72628430|NCT03950856|144784709|OTHER||GMC Ratio|9.42|||||TWO_SIDED|95.0|7.96|11.13|||||V114 Combined Lots divided by Prevnar 13™|Serotype 33F: GMC Ratio V114 Combined Lots / Prevnar 13™|GMC ratio and 95% CI were estimated from a cLDA model.|11.13|7.96|
72628431|NCT01174563|144784763|SUPERIORITY||Hazard Ratio (HR)|0.58||||0.005|TWO_SIDED|95.0|0.41|0.83|||Log Rank|||||0.83|0.41|0.005
72542683|NCT04288115|144615454|OTHER|A two-sided α-level of 0.05 will be used to determine the statistical significance.|Difference in Group Means|2.3||||0.7104|TWO_SIDED|95.0|-10.1|14.7||Testing whether group means are different.|ANCOVA|A p-value \< 0.05 indicates real discontinuation mean and sham discontinuation mean are different. Analyses adjusted for gender and baseline score.|Differences reported as the sham discontinuation mean minus the real discontinuation mean. These mean differences have been adjusted for gender and baseline tiredness score.|Analysis of 6-week outcome||14.7|-10.1|0.7104
72542684|NCT04288115|144615454|OTHER|A two-sided α-level of 0.05 will be used to determine statistical significance.|Difference in Group Means|5.4||||0.3381|TWO_SIDED|95.0|-5.9|16.7||Group differences.|ANCOVA|A p-value \< 0.05 indicates real discontinuation mean and sham discontinuation mean are different. Analyses adjusted for gender and baseline score.|Differences reported as sham discontinuation mean minus real discontinuation mean. These differences have been adjusted for gender and baseline tiredness scores.|Analysis of 6-month outcome||16.7|-5.9|0.3381
72542685|NCT04288115|144615455|OTHER|A two-sided α-level of 0.05 will be used to determine the statistical significance.|Difference in Group Means|-0.02||||0.4684|TWO_SIDED|95.0|-0.076|0.036||Testing whether group means are different.|ANCOVA|A p-value \< 0.05 indicates real discontinuation mean and sham discontinuation mean are different. Analyses adjusted for gender and baseline score.|Differences reported as the sham discontinuation mean minus the real discontinuation mean. These differences have been adjusted for gender and baseline EQ-5D Descriptive scores.|Analysis of 6-week EQ-5D Descriptive score outcome.||0.036|-0.076|0.4684
72542686|NCT04288115|144615455|OTHER|A two-sided α-level of 0.05 will be used to determine the statistical significance.|Difference in Group Means|0.003||||0.9585|TWO_SIDED|95.0|-0.102|0.107||Testing whether group means are different.|ANCOVA|A p-value \< 0.05 indicates real discontinuation mean and sham discontinuation mean are different. Analyses adjusted for gender and baseline score.|Differences reported as the sham discontinuation mean minus the real discontinuation mean. These differences have been adjusted for gender and baseline EQ-5D Descriptive scores.|Analysis of 6-month EQ-5D Descriptive score outcome.||0.107|-0.102|0.9585
72542687|NCT04288115|144615455|OTHER|A two-sided α-level of 0.05 will be used to determine the statistical significance.|Difference in Group Means|7.0||||0.0643|TWO_SIDED|95.0|-0.4|14.4||Testing whether group means are different.|ANCOVA|A p-value \< 0.05 indicates real discontinuation mean and sham discontinuation mean are different. Analyses adjusted for gender and baseline score.|Differences reported as the sham discontinuation mean minus the real discontinuation mean. These differences have been adjusted for gender and baseline EQ-5D VAS scores.|Analysis of 6-week EQ-5D VAS score outcome.||14.4|-0.4|0.0643
72542688|NCT04288115|144615455|OTHER|A two-sided α-level of 0.05 will be used to determine the statistical significance.|Difference in Group Means|-6.2||||0.1742|TWO_SIDED|95.0|-15.3|2.9||Testing whether group means are different.|ANCOVA|A p-value \< 0.05 indicates real discontinuation mean and sham discontinuation mean are different. Analyses adjusted for gender and baseline scores.|Differences reported as the sham discontinuation mean minus the real discontinuation mean. These differences have been adjusted for gender and baseline EQ-5D VAS scores.|Analysis of 6-month EQ-5D VAS score outcome.||2.9|-15.3|0.1742
72542689|NCT04288115|144615456|OTHER|A two-sided α-level of 0.05 will be used to determine the statistical significance.|Difference in Group Means|-12.0||||0.1695|TWO_SIDED|95.0|-29.3|5.3||Testing whether group means are different.|ANCOVA|A p-value \< 0.05 indicates real discontinuation mean and sham discontinuation mean are different. Analyses adjusted for gender and baseline value.|Differences reported as the sham discontinuation mean minus the real discontinuation mean. These differences have been adjusted for gender and baseline total cholesterol value.|Analysis of 6-month total cholesterol outcome.||5.3|-29.3|0.1695
72542690|NCT04288115|144615456|OTHER|A two-sided α-level of 0.05 will be used to determine the statistical significance.|Difference in Group Means|-6.8||||0.3805|TWO_SIDED|95.0|-22.2|8.6||Testing whether group means are different.|ANCOVA|A p-value \< 0.05 indicates real discontinuation mean and sham discontinuation mean are different. Analyses adjusted for gender and baseline value.|Differences reported as the sham discontinuation mean minus the real discontinuation mean. These differences have been adjusted for gender and baseline LDL values.|Analysis of 6-month LDL outcome.||8.6|-22.2|0.3805
72577194|NCT02952586|144680987|SUPERIORITY||Hazard Ratio (HR)|1.21||||0.9061|TWO_SIDED|95.0|0.909|1.624||The treatment arms were compared using a stratified, 1-sided, log rank Test. The three stratification factors were tumor stage (\< T4 vs T4), Nodal stage (N0 /N1/N2a/N2b vs N2c/N3), HPV status (Positive vs Negative).|Log Rank|||||1.624|0.909|0.9061
72577195|NCT04411914|144681011|SUPERIORITY|||||||0.0009|||||||Spearman Correlation Coefficient|||||||0.0009
72577196|NCT04411914|144681012|OTHER|||||||0.0053|||||||Spearman Correlation Coefficient|"Spearman Correlation Coefficient, N=9 Prob \> \|r\| under H0: Rho=0"||||||0.0053
72577197|NCT01778634|144681016|SUPERIORITY||Odds Ratio (OR)|7.51|||<|0.0001|TWO_SIDED|95.0|2.53|22.27|||Cochran-Mantel-Haenszel|||||22.27|2.53|<0.0001
72577198|NCT01778634|144681017|SUPERIORITY||Risk Difference (RD)|0.11||||0.28|TWO_SIDED|95.0|-0.08|0.29|||Generalized Estimating Equations||Generalized Estimating Equations with an identity link|||0.29|-0.08|0.28
72577199|NCT01778634|144681018|SUPERIORITY|P values are based on GEE to account for twins||||||0.11|||||||GEE|||||||0.11
72628432|NCT01347060|144784774|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.8||||0.0051|TWO_SIDED|95.0|0.68|0.93||The P-value relates to differences in combined inpatient/emergency department.|Regression, Cox|Adjusted for baseline differences||||0.93|0.68|0.0051
72628433|NCT01347060|144784775|SUPERIORITY_OR_OTHER||Mean Difference (Net)|883.23||||0.001|TWO_SIDED|95.0|731.66|1041.69||The P-value is on the adjusted difference in total asthma costs.|Regression, Linear|Generalized Linear Model with a log-link and a gamma distribution adjusting for differences at baseline||||1041.69|731.66|0.001
72628434|NCT01347060|144784776|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.0001
72329428|NCT02574078|144184362|SUPERIORITY||Hazard Ratio (HR)|0.85||||0.5489|TWO_SIDED|95.0|0.5|1.45|||Log Rank|stratified by Disease Status (Recurrent Locally Advanced vs. Metastatic), Performance Status (ECOG 0 vs.1 vs. 2) as entered into the IVRS||||1.45|0.50|0.5489
72329429|NCT02574078|144184363|SUPERIORITY||Hazard Ratio (HR)|1.0||||0.9951|TWO_SIDED|95.0|0.35|2.91|||Unstratified log-rank|||||2.91|0.35|0.9951
72542691|NCT04288115|144615456|OTHER|A two-sided α-level of 0.05 will be used to determine the statistical significance.|Difference in Group Means|1.7||||0.5724|TWO_SIDED|95.0|-4.44|7.9||Testing whether group means are different.|ANCOVA|A p-value \< 0.05 indicates real discontinuation mean and sham discontinuation mean are different. Analyses adjusted for gender and baseline value.|Differences reported as the sham discontinuation mean minus the real discontinuation mean. These differences have been adjusted for gender and baseline HDL values.|Analysis of 6-month HDL outcome.||7.9|-4.44|0.5724
72542692|NCT04288115|144615456|OTHER|A two-sided α-level of 0.05 will be used to determine the statistical significance.|Difference in Group Means|-17.8||||0.3939|TWO_SIDED|95.0|-59.4|23.9||Testing whether group means are different.|ANCOVA|A p-value \< 0.05 indicates real discontinuation mean and sham discontinuation mean are different. Analyses adjusted for gender and baseline value.|Differences reported as the sham discontinuation mean minus the real discontinuation mean. These differences have been adjusted for gender and baseline triglyceride values.|Analysis of 6-month triglyceride outcome.||23.9|-59.4|0.3939
72542693|NCT04128696|144615501|SUPERIORITY||Hazard Ratio (HR)|1.51||||0.973|TWO_SIDED|95.0|0.99|2.29||Nominal p-value was calculated based on the one-sided log-rank test, stratified by PD-L1 expression (CPS ≥20 vs. 1≤ CPS \<20) and HPV status (oropharynx HPV positive vs oropharynx HPV negative/unknown and non-oropharynx).|Stratified Cox proportional hazard model|||The hazard ratio and 2-sided 95% CI was calculated from the Cox regression model with Efron's method of tie handling, a treatment covariate and stratified by PD-L1 expression (CPS ≥20 vs. 1≤ CPS \<20) and HPV status (oropharynx HPV positive vs oropharynx HPV negative/unknown and non-oropharynx).||2.29|0.99|0.973
72542694|NCT04128696|144615502|SUPERIORITY||Hazard Ratio (HR)|4.44|||>|0.999|TWO_SIDED|95.0|2.01|9.82||Nominal p-value was calculated based on the one-sided log-rank test, stratified by HPV status (oropharynx HPV positive vs oropharynx HPV negative/unknown and non-oropharynx).|Stratified Cox proportional hazard model|||The hazard ratio and 2-sided 95% CI was calculated from the Cox regression model with Efron's method of tie handling, a treatment covariate and stratified by HPV status (oropharynx HPV positive vs oropharynx HPV negative/unknown and non-oropharynx).||9.82|2.01|>0.999
72542695|NCT04128696|144615503|SUPERIORITY||Hazard Ratio (HR)|1.4||||0.989|TWO_SIDED|95.0|1.05|1.86||Nominal p-value was calculated based on the log-rank test, stratified by stratified by PD-L1 expression (CPS ≥20 vs. 1≤ CPS \<20) and HPV status (oropharynx HPV positive vs oropharynx HPV negative/unknown and non-oropharynx).|Stratified Cox proportional hazard model|||The hazard ratio and 2-sided 95% CI was calculated from the Cox regression model with Efron's method of tie handling, a treatment covariate and stratified by PD-L1 expression (CPS ≥20 vs. 1≤ CPS \<20) and HPV status (oropharynx HPV positive vs oropharynx HPV negative/unknown and non-oropharynx).||1.86|1.05|0.989
72542696|NCT04128696|144615504|SUPERIORITY||Hazard Ratio (HR)|1.48||||0.996|TWO_SIDED|95.0|1.1|1.99||Nominal p-value was calculated based on the log-rank test, stratified by PD-L1 expression (CPS ≥20 vs. 1≤ CPS \<20) and HPV status (oropharynx HPV positive vs oropharynx HPV negative/unknown and non-oropharynx).|Stratified Cox proportional hazard model|||The hazard ratio and 2-sided 95% CI was calculated from the cox regression model with Efron's method of tie handling, a treatment covariate and stratified by PD-L1 expression (CPS ≥20 vs. 1≤ CPS \<20) and HPV status (oropharynx HPV positive vs oropharynx HPV negative/unknown and non-oropharynx)||1.99|1.10|0.996
72542697|NCT04128696|144615505|SUPERIORITY||Hazard Ratio (HR)|1.55|||||TWO_SIDED|95.0|0.98|2.43|||Stratified Cox proportional hazard model|||The hazard ratio and 2-sided 95% CI was calculated from the Cox regression model with Efron's method of tie handling, a treatment covariate and stratified by HPV status (oropharynx HPV positive vs oropharynx HPV negative/unknown and non-oropharynx)||2.43|0.98|
72542698|NCT04128696|144615506|SUPERIORITY||Hazard Ratio (HR)|1.59|||||TWO_SIDED|95.0|1.0|2.53|||Stratified Cox proportional hazard model|||The hazard ratio and 2-sided 95% CI was calculated from the Cox regression model with Efron's method of tie handling, a treatment covariate and stratified by HPV status (oropharynx HPV positive vs oropharynx HPV negative/unknown and non-oropharynx).||2.53|1.00|
72542699|NCT04128696|144615511|OTHER||Difference in Percentage|-5.3|||||TWO_SIDED|95.0|-14.6|4.0||||||The comparison between the treatment groups was based on the stratified Miettinen \& Nurminen method with strata weighting by sample size and a single treatment covariate. Stratification factors included PD-L1 expression (CPS ≥20 vs. 1≤ CPS \<20) and HPV status (positive vs. negative). Participants with oropharynx HPV negative/unknown and non-oropharyngeal tumors were combined as the HPV negative group.||4.0|-14.6|
72542700|NCT04128696|144615512|OTHER||Difference in Percentage|-13.3|||||TWO_SIDED|95.0|-27.8|1.5||||||The comparison between the treatment groups was based on the stratified Miettinen \& Nurminen method with strata weighting by sample size and a single treatment covariate. Stratification factors included HPV status (positive vs. negative). Participants with oropharynx HPV negative/unknown and non-oropharyngeal tumors were combined as the HPV negative group.||1.5|-27.8|
72577200|NCT01778634|144681019|SUPERIORITY|P values are based on GEE to account for twins. The counts provided refer to to the numbers actually observed. The analysis to determine the p value accounted for the missing 11 patients using multiple imputation.||||||0.62|||||||GEE with multiple imputation|||||||0.62
72577201|NCT01778634|144681020|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.0
72577202|NCT01778634|144681021|SUPERIORITY|||||||0.88||||||To include non-survivors as bad values of this outcome we imputed a high value for the participants who died. Note, because we analyzed the data using a nonparametric test, the actual value doesn't affect the analysis, only the rank of the value.|Wilcoxon (Mann-Whitney)|||||||0.88
72577203|NCT01778634|144681022|SUPERIORITY||Median Difference (Final Values)|5.0||||0.94|TWO_SIDED|95.0|-15.0|26.0||To include non-survivors as bad values of this outcome we imputed a high value for the participants who died. Note, because we analyzed the data using a nonparametric test, the actual value doesn't affect the analysis, only the rank of the value.|Wilcoxon test after multiple outputation||Bootstrap|||26|-15|0.94
72329430|NCT02574078|144184363|SUPERIORITY||Hazard Ratio (HR)|0.87||||0.8321|TWO_SIDED|95.0|0.25|3.1|||Unstratified log-rank|||||3.10|0.25|0.8321
72577204|NCT01778634|144681023|SUPERIORITY|||||||0.49|||||||Fisher Exact|||||||0.49
72628435|NCT01542788|144784783|SUPERIORITY_OR_OTHER||Proportion difference|77.3|||<|0.001|TWO_SIDED|95.0|71.0|83.6||P-value is from the Cochran-Mantel-Haenszel test stratified by presence or absence of cirrhosis for the superiority of SOF+RBV over placebo.|Cochran-Mantel-Haenszel||The difference in proportions between treatment groups and associated 95% confidence interval (CI) are calculated based on stratum-adjusted Mantel-Haenszel proportions.|A sample size of 180 subjects in the active group and 60 in the placebo group would provide 99% power to detect a difference between group SVR12 rates of 40% using a 2-sided continuity-corrected chi-square test at significance level of 0.05.||83.6|71.0|< 0.001
72628436|NCT01542788|144784785|SUPERIORITY_OR_OTHER||Proportion difference|82.7|||||TWO_SIDED|95.0|76.8|88.5|||||The difference in proportions between treatment groups and associated 95% CI are calculated based on stratum-adjusted Mantel-Haenszel proportions.|||88.5|76.8|
72628437|NCT01542788|144784786|SUPERIORITY_OR_OTHER||Proportion difference|77.3|||<|0.001|TWO_SIDED|95.0|71.0|83.6||P-value is from the Cochran-Mantel-Haenszel test stratified by randomization stratification factor for the superiority of SOF+RBV over placebo.|Cochran-Mantel-Haenszel||The difference in proportions between treatment groups and associated 95% CI are calculated based on stratum-adjusted Mantel-Haenszel proportions.|||83.6|71.0|< 0.001
72628438|NCT04704193|144784793|OTHER|This arm includes descriptive statistics only.|count with proportion|0.955|||||TWO_SIDED|95.0|0.888|0.987||||||"Descriptive statistics only/proportion reported good or excellent~Q1a. Genetic testing is a blood test that looks for mutations in genes that can increase cancer risk"||.987|.888|
72628439|NCT04704193|144784793|OTHER|This arm includes descriptive statistics only.|count with proportion|0.931|||||TWO_SIDED|95.0|0.856|0.974||||||"Descriptive statistics only/proportion reported good or excellent~Q1b. Genetic test results may help guide my treatment options"||.974|.856|
72628440|NCT04704193|144784793|OTHER|This arm includes descriptive statistics only.|count with proportion|0.943|||||TWO_SIDED|95.0|0.872|0.981||||||"Descriptive statistics only/proportion reported good or excellent~Q1c. Genetic test results may help me understand the future risks of other cancers"||.981|.872|
72628441|NCT04704193|144784793|OTHER|This arm includes descriptive statistics only.|count with proportion|0.851|||||TWO_SIDED|95.0|0.758|0.918||||||"Descriptive statistics only/proportion reported good or excellent~Q1d. Genetic test results may increase stress to me and my family members"||.918|.758|
72628442|NCT04704193|144784793|OTHER|This arm includes descriptive statistics only.|count with proportion|0.931|||||TWO_SIDED|95.0|0.856|0.974||||||"Descriptive statistics only/proportion reported good or excellent~Q1e. There are 3 gene panel options that include either a small, medium, or large number of genes"||.974|.856|
72628443|NCT04704193|144784793|OTHER|This arm includes descriptive statistics only.|count with proportion|0.919|||||TWO_SIDED|95.0|0.839|0.967||||||"Descriptive statistics only/proportion reported good or excellent~Q1f. Gene test results may come back as positive, negative or uncertain"||.967|.839|
72628444|NCT04704193|144784794|OTHER|Summary statistics only|Mean|13.7|STANDARD_DEVIATION|5.6|||TWO_SIDED|||||||||||||
72628445|NCT00542178|144784795|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.67||||0.003|TWO_SIDED|95.0|0.51|0.87|||Regression, Logistic|Comparisons made using likelihood-ratio tests from logistic-regression models with adjustment for same study-design factors used in ACCORD analysis||Our recruitment goal for the ACCORD Eye study was set in order to achieve a statistical power of 88% to detect a 15% relative reduction with intensive glycemic control as compared with standard glycemic control||0.87|0.51|0.003
72628446|NCT00542178|144784795|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.23||||0.29|TWO_SIDED|95.0|0.84|1.79|||Regression, Logistic|Comparisons made using likelihood-ratio tests from logistic-regression models with adjustment for same study-design factors used in ACCORD analysis||Our recruitment goal for the ACCORD Eye study was set in order to achieve a statistical power of 80% to detect a 20% relative reduction with intensive blood pressure control as compared with standard blood pressure control||1.79|0.84|0.29
72628447|NCT00542178|144784795|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.6||||0.006|TWO_SIDED|95.0|0.42|0.87|||Regression, Logistic|Comparisons made using likelihood-ratio tests from logistic-regression models with adjustment for same study-design factors used in ACCORD analysis||Our recruitment goal for the ACCORD Eye study was set in order to achieve a statistical power of 91% to detect a 20% relative reduction with lipid control with a statin and fenofibrate as compared with lipid control with a statin alone||0.87|0.42|0.006
72628448|NCT00542178|144784796|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.997||||0.96|TWO_SIDED|95.0|0.901|1.104|||Regression, Cox|||||1.104|0.901|0.96
72628449|NCT00542178|144784796|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.952||||0.5|TWO_SIDED|95.0|0.825|1.099|||Regression, Cox|||||1.099|0.825|0.50
72628450|NCT00542178|144784796|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.88||||0.08|TWO_SIDED|95.0|0.762|1.016|||Regression, Cox|||||1.016|0.762|0.08
72628451|NCT00542178|144784797|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.884||||0.0355|TWO_SIDED|95.0|0.788|0.992|||Regression, Cox|||||0.992|0.788|0.0355
72628452|NCT00542178|144784797|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.891||||0.17|TWO_SIDED|95.0|0.755|1.051|||Regression, Cox|||||1.051|0.755|0.17
72628453|NCT00542178|144784797|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.015||||0.86|TWO_SIDED|95.0|0.865|1.19|||Regression, Cox|||||1.190|0.865|0.86
72628454|NCT00542178|144784798|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.09||||0.069|TWO_SIDED|95.0|0.71|1.69|||Regression, Logistic|||||1.69|0.71|0.069
72628455|NCT00542178|144784798|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.85||||0.63|TWO_SIDED|95.0|0.44|1.63|||Regression, Logistic|||||1.63|0.44|0.63
72329431|NCT02574078|144184363|SUPERIORITY||Hazard Ratio (HR)|0.74||||0.2938|TWO_SIDED|95.0|0.41|1.31|||Unstratified log-rank|||||1.31|0.41|0.2938
72628456|NCT00542178|144784798|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.09||||0.78|TWO_SIDED|95.0|0.6|1.96|||Regression, Logistic|||||1.96|0.60|0.78
72628457|NCT03449576|144784799|SUPERIORITY||Slope|5.3846|STANDARD_ERROR_OF_MEAN|6.5525||0.4154|TWO_SIDED|||||This P value is the interaction term between Visit and Treatment.|Regression, Linear||This is the beta value for the interaction term between Visit and Treatment.|Test of prediction of dependent variable -- the CAPS score-- with the interaction between Visit (pre/post) and treatment type (TMT vs. EXP+EDU), as well as independent variable, age||||0.4154
72628458|NCT03449576|144784800|SUPERIORITY||Slope|0.267397|STANDARD_ERROR_OF_MEAN|0.362521||0.4636|TWO_SIDED|||||This P value is the interaction term between Visit and Treatment.|Regression, Linear||This is the beta value for the interaction term between Visit and Treatment.|Test of prediction of dependent variable -- the SAS-SR score-- with the interaction between Visit (pre/post) and Treatment type (TMT vs. EXP+EDU), as well as independent variable, age||||0.4636
72628459|NCT03449576|144784801|SUPERIORITY||Slope|2.3355|STANDARD_ERROR_OF_MEAN|6.8791||0.735129|TWO_SIDED|||||This P value is the interaction term between Visit and Treatment.|Regression, Linear||This is the beta value for the interaction term between Visit and Treatment.|Test of prediction of dependent variable -- the PCL score-- with the interaction between Visit (pre/post) and treatment type (TMT vs. EXP+EDU), as well as independent variable, age||||0.735129
72628460|NCT03449576|144784802|SUPERIORITY||Slope|-2.64908|STANDARD_ERROR_OF_MEAN|4.76601||0.58|TWO_SIDED|||||This P value is the interaction term between Visit and Treatment.|Regression, Linear||This is the beta value for the interaction term between Visit and Treatment.|Test of prediction of dependent variable -- the AQ score-- with the interaction between Visit (pre/post) and treatment type (TMT vs. EXP+EDU), as well as independent variable, age||||0.580
72628461|NCT03449576|144784803|SUPERIORITY||Slope|1.3946|STANDARD_ERROR_OF_MEAN|5.7193||0.808|TWO_SIDED|||||This P value is the interaction term between Visit and Treatment.|Regression, Linear||This is the beta value for the interaction term between Visit and Treatment.|Test of prediction of dependent variable -- the ITS score-- with the interaction between Visit (pre/post) and treatment type (TMT vs. EXP+EDU), as well as independent variable, age||||0.808
72628462|NCT01492426|144784818|NON_INFERIORITY_OR_EQUIVALENCE|Test of noninferiority was based on noninferiority margin of -12% and 2-sided alpha level of 5%. That is, if the lower bound of the 95% CI \> -12%, the Daclatasvir arm would be considered nonnferior to the telaprevir arm.|Percentage difference|4.3|STANDARD_DEVIATION|3.885|||TWO_SIDED|95.0|-3.3|11.9||Test of noninferiority carried out by taking a confidence interval (CI) for the difference in rates (daclatasvir arm minus telapravir arm). If lower bound of 95% CI difference exceeded -12%, noninferiority was demonstrated. No p-value was computed.|Stratum-adjusted Mantel-Haenszel|||Percentage difference between SVR12 rate in the experimental and control arms was computed using a stratum-adjusted Mantel-Haenszel confidence interval (95% level) for the difference in rates. The stratification factors were IL28B rs1297860 single nucleotide polymorphism (CC or non-CC) and baseline cirrhosis status (absent or present), unless otherwise indicated.||11.9|-3.3|
72628463|NCT02026011|144784827|SUPERIORITY_OR_OTHER|||||||0.39||||||Medication effect: b = -0.15, SE = 0.17, t = -0.86, p = 0.39|Mixed Models Analysis|||||||0.39
72628464|NCT02026011|144784827|SUPERIORITY_OR_OTHER|||||||0.34||||||Genotype effect: b = 0.20, SE = 0.21, t = 0.96, p = 0.34|Mixed Models Analysis|||||||0.34
72628465|NCT02026011|144784827|SUPERIORITY_OR_OTHER|||||||0.04||||||BrAC effect: b = 0.13, SE = 0.06, t = 2.10, p = 0.04|Mixed Models Analysis|||||||0.04
72628466|NCT02026011|144784827|SUPERIORITY_OR_OTHER|||||||0.47||||||Medication by genotype interaction: b = 0.15, SE = 0.21, t = 0.73, p = 0.47|Mixed Models Analysis|||||||0.47
72628467|NCT02026011|144784827|SUPERIORITY_OR_OTHER|||||||0.13||||||Medication by genotype by BrAC interaction: b = -0.20, SE = 0.13, t = -1.52, p = 0.13|Mixed Models Analysis|||||||0.13
72628468|NCT02026011|144784828|SUPERIORITY_OR_OTHER|||||||0.23||||||Medication effect: b = 0.16, SE = 0.13, t = 1.20, p = 0.23|Mixed Models Analysis|||||||0.23
72628469|NCT02026011|144784828|SUPERIORITY_OR_OTHER|||||||0.09||||||Genotype effect: b = 0.37, SE = 0.22, t = 1.69, p = 0.09|Mixed Models Analysis|||||||0.09
72628470|NCT02026011|144784828|SUPERIORITY_OR_OTHER|||||||0.84||||||Medication by genotype interaction: b = 0.04, SE = 0.21, t = 0.20, p = 0.84|Mixed Models Analysis|||||||0.84
72577205|NCT01778634|144681024|SUPERIORITY||Odds Ratio (OR)|1.07||||0.88|TWO_SIDED|95.0|0.44|2.63|||Cochran-Mantel-Haenszel|||||2.63|0.44|0.88
72577206|NCT01778634|144681025|SUPERIORITY|||||||0.18|||||||Generalized Estimating Equations|||||||0.18
72628471|NCT02026011|144784828|SUPERIORITY_OR_OTHER|||||||0.05||||||Medication by genotype by BrAC interaction: b = -0.32, SE = 0.16, t = -1.93, p = 0.05|Mixed Models Analysis|||||||0.05
72628472|NCT02026011|144784829|SUPERIORITY_OR_OTHER|||||||0.55||||||Medication effect: b = 0.14, SE = 0.23, t = 0.61, p = 0.55|Mixed Models Analysis|||||||0.55
72577207|NCT01778634|144681027|SUPERIORITY|||||||0.05|||||||Generalized Estimating Equation|||||||0.05
72577208|NCT01778634|144681028|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.0
72577209|NCT01778634|144681029|SUPERIORITY|||||||0.18|||||||Generalized Estimating Equations|||||||0.18
72628473|NCT02026011|144784829|SUPERIORITY_OR_OTHER|||||||0.77||||||Genotype effect: b = -0.11, SE = 0.37, t = -0.30, p = 0.77|Mixed Models Analysis|||||||0.77
72628474|NCT02026011|144784829|SUPERIORITY_OR_OTHER|||||||0.04||||||BrAC effect: b = 0.30, SE = 0.15, t = 2.02, p = 0.04|Mixed Models Analysis|||||||0.04
72577210|NCT01778634|144681030|SUPERIORITY|||||||0.091|||||||Fisher Exact|||||||0.091
72628475|NCT02026011|144784829|SUPERIORITY_OR_OTHER|||||||0.47||||||Medication by genotype interaction: b = -0.21, SE = 0.29, t = -0.72, p = 0.47|Mixed Models Analysis|||||||0.47
72628476|NCT02026011|144784829|SUPERIORITY_OR_OTHER|||||||0.19||||||Medication by genotype by BrAC interaction: b = 0.28, SE = 0.21, t = 1.30, p = 0.19|Mixed Models Analysis|||||||0.19
72628477|NCT02026011|144784831|SUPERIORITY_OR_OTHER|||||||0.14||||||Medication effect: F(1,71) = 2.24, p = 0.14|Poisson Regression|||||||0.14
72628478|NCT02026011|144784831|SUPERIORITY_OR_OTHER|||||||0.02||||||Genotype effect: F(1, 71) = 5.79, p = 0.02|Poisson|||||||0.02
72577211|NCT01778634|144681031|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.0
72577212|NCT01778634|144681032|SUPERIORITY|||||||0.33|||||||Generalized Estimating Equations|||||||0.33
72577213|NCT01778634|144681033|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.0
72577214|NCT00719615|144681049|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05||95.0||||Only risk factors significant at the 0.10 level in univariate analysis were included in the multivariate model.|Fisher Exact|||Patient characteristics for each group were assessed using descriptive statistics, including medians, range, frequencies, and proportions. Categorical outcomes were compared between the 3 groups using a Fisher's exact test. A logistic regression modeling procedure was used to compare the odds of a low vitamin D levels between patient groups while adjusting for other risk factors: gender, age, BMI, season, and TNM staging.||||<0.05
72628479|NCT02026011|144784831|SUPERIORITY_OR_OTHER|||||||0.41||||||Medication by genotype interaction: F(1, 70) = 0.68, p = 0.41.|Poisson|||||||0.41
72577215|NCT00345943|144681065|OTHER||Mean Difference (Net)|-0.1|STANDARD_ERROR_OF_MEAN|0.04||0.03|TWO_SIDED||||||Mixed Models Analysis|Growth curve models with between-within degrees of freedom and a random effect for the intercept and fixed effects for predictors.|BN versus HC group effect|Growth curve models examined the following: group (BN versus HC) differences in cortical thickness (CT) at baseline; group differences in the rate of change in CT over time; and the persistence of group differences in CT over time.||||.03
72577216|NCT00345943|144681065|OTHER||Slope|0.053|STANDARD_ERROR_OF_MEAN|0.047|<|0.05|TWO_SIDED|95.0|-0.04|0.15|||Mixed Models Analysis|Growth curve models with between-within degrees of freedom and a random effect for the intercept and fixed effects for predictors.||Growth curve models examined the following: group (BN versus HC) differences in conflict-related BOLD signal at baseline; group differences in the rate of change in conflict-related BOLD signal over time; and the persistence of group differences in conflict-related BOLD signal over time.||0.15|-0.04|<.05
72577217|NCT00789737|144681069|SUPERIORITY_OR_OTHER|||||||0.0369||95.0|||||ANCOVA|||least squares mean; 80% power to detect a 0.3% change||||0.0369
72577218|NCT00789737|144681070|SUPERIORITY_OR_OTHER|||||||0.0373||95.0|||||ANCOVA|||||||0.0373
72577219|NCT00789737|144681075|SUPERIORITY_OR_OTHER||||||<|1e-05||95.0|||||ANCOVA|||||||<0.00001
72577220|NCT00384930|144681094|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Change from Baseline. Change = Endpoint minus Baseline.|Permutation Test|||This is the principal inferential analysis of the primary outcome.||||<0.001
72577221|NCT00384930|144681095|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.57||||0.025||95.0|-1.08|-0.07||P-value for Change from Baseline. Change=Endpoint - Baseline. P-values from ANCOVA model with effect of treatment group, geographic region, and baseline value of analyzed variable as a covariate, and were not adjusted for multiple comparisons.|ANCOVA||Mean Difference = 2.5 mg Tadalafil minus Placebo|||-0.07|-1.08|0.025
72577222|NCT00384930|144681095|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.9|||<|0.001||95.0|-1.4|-0.4||P-value for Change from Baseline. Change=Endpoint - Baseline. P-values from ANCOVA model with effect of treatment group, geographic region, and baseline value of analyzed variable as a covariate, and were not adjusted for multiple comparisons.|ANCOVA||Mean Difference = 5 mg Tadalafil minus Placebo|||-0.40|-1.40|<0.001
72577223|NCT00384930|144681095|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.96|||<|0.001||95.0|-1.45|-0.46||P-value for Change from Baseline. Change=Endpoint - Baseline. P-values from ANCOVA model with effect of treatment group, geographic region, and baseline value of analyzed variable as a covariate, and were not adjusted for multiple comparisons.|ANCOVA||Mean Difference = 10 mg Tadalafil minus Placebo|||-0.46|-1.45|<0.001
72577224|NCT00384930|144681095|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.07|||<|0.001||95.0|-1.58|-0.57||P-value for Change from Baseline. Change=Endpoint - Baseline. P-values from ANCOVA model with effect of treatment group, geographic region, and baseline value of analyzed variable as a covariate, and were not adjusted for multiple comparisons.|ANCOVA||Mean Difference = 20 mg Tadalafil minus Placebo|||-0.57|-1.58|<0.001
72577225|NCT00384930|144681096|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.97||||0.008||95.0|-1.69|-0.26||P-value for Change from Baseline. Change=Endpoint - Baseline. P-values from ANCOVA model with effect of treatment group, geographic region, and baseline value of analyzed variable as a covariate, and were not adjusted for multiple comparisons.|ANCOVA||Mean Difference = 2.5 mg Tadalafil minus Placebo|||-0.26|-1.69|0.008
72577226|NCT00384930|144681096|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.69|||<|0.001||95.0|-2.4|-0.98||P-value for Change from Baseline. Change=Endpoint - Baseline. P-values from ANCOVA model with effect of treatment group, geographic region, and baseline value of analyzed variable as a covariate, and were not adjusted for multiple comparisons.|ANCOVA||Mean Difference = 5 mg Tadalafil minus Placebo|||-0.98|-2.40|<0.001
72628480|NCT00272792|144784893|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 1 sided|||Compared Week 10 to Baseline.||||<0.001
72628481|NCT00272792|144784893|SUPERIORITY_OR_OTHER|||||||0.027||95.0|||||t-test, 1 sided|||Compared Week 10 to Baseline.||||0.027
72577227|NCT00384930|144681096|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.89|||<|0.001||95.0|-2.6|-1.18||P-value for Change from Baseline. Change=Endpoint - Baseline. P-values from ANCOVA model with effect of treatment group, geographic region, and baseline value of analyzed variable as a covariate, and were not adjusted for multiple comparisons.|ANCOVA||Mean Difference = 10 mg Tadalafil minus Placebo|||-1.18|-2.60|<0.001
72577228|NCT00384930|144681096|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.87|||<|0.001||95.0|-2.59|-1.15||P-value for Change from Baseline. Change=Endpoint - Baseline. P-values from ANCOVA model with effect of treatment group, geographic region, and baseline value of analyzed variable as a covariate, and were not adjusted for multiple comparisons.|ANCOVA||Mean Difference = 20 mg Tadalafil minus Placebo|||-1.15|-2.59|<0.001
72577229|NCT00384930|144681097|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.07||||0.503||95.0|-0.28|0.14||P-value for Change from Baseline. Change=Endpoint - Baseline. P-values from ANCOVA model with effect of treatment group, geographic region, and baseline value of analyzed variable as a covariate, and were not adjusted for multiple comparisons.|ANCOVA||Mean Difference = 2.5 mg Tadalafil minus Placebo|||0.14|-0.28|0.503
72577230|NCT00384930|144681097|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.13||||0.206||95.0|-0.34|0.07||P-value for Change from Baseline. Change=Endpoint - Baseline. P-values from ANCOVA model with effect of treatment group, geographic region, and baseline value of analyzed variable as a covariate, and were not adjusted for multiple comparisons.|ANCOVA||Mean Difference = 5 mg Tadalafil minus Placebo|||0.07|-0.34|0.206
72577231|NCT00384930|144681097|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.08||||0.452||95.0|-0.28|0.13||P-value for Change from Baseline. Change=Endpoint - Baseline. P-values from ANCOVA model with effect of treatment group, geographic region, and baseline value of analyzed variable as a covariate, and were not adjusted for multiple comparisons.|ANCOVA||Mean Difference = 10 mg Tadalafil minus Placebo|||0.13|-0.28|0.452
72628482|NCT00272792|144784894|SUPERIORITY_OR_OTHER|||||||0.009||95.0|||||Longitudinal Model|Longitudinal model with blood Phe measurements as the response variable and treatment group, visit, and baseline blood Phe level as covariates.||||||0.009
72628483|NCT02921789|144784895|SUPERIORITY||Difference|-12.7||||0.3705|TWO_SIDED|95.0|-34.5|9.0||Incidence rate comparisons are based on Fisher's Exact test and confidence intervals are based on Normal Approximation.|Fisher Exact|||||9.0|-34.5|0.3705
72628484|NCT02921789|144784896|SUPERIORITY||Difference|-12.7||||0.3705|TWO_SIDED|95.0|-34.5|9.0||Incidence rate comparisons are based on Fisher's Exact test and confidence intervals are based on Normal Approximation.|Fisher Exact|||Month 6||9.0|-34.5|0.3705
72628485|NCT02921789|144784896|SUPERIORITY||Difference|-12.4||||0.389|TWO_SIDED|95.0|-35.8|11.0||Incidence rate comparisons are based on Fisher's Exact test and confidence intervals are based on Normal Approximation.|Fisher Exact|||Month 12||11.0|-35.8|0.3890
72628486|NCT02921789|144784897|SUPERIORITY||Difference|6.9||||0.752|TWO_SIDED|95.0|-15.3|29.2||Incidence rate comparisons are based on Fisher's Exact test and confidence intervals are based on Normal Approximation.|Fisher Exact|||Month 3||29.2|-15.3|0.7520
72628487|NCT02921789|144784897|SUPERIORITY||Difference|6.9||||0.752||95.0|-15.3|29.2||Incidence rate comparisons are based on Fisher's Exact test and confidence intervals are based on Normal Approximation.|Fisher Exact|||Month 6||29.2|-15.3|0.7520
72577232|NCT00384930|144681097|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.26||||0.012||95.0|-0.47|-0.06||P-value for Change from Baseline. Change=Endpoint - Baseline. P-values from ANCOVA model with effect of treatment group, geographic region, and baseline value of analyzed variable as a covariate, and were not adjusted for multiple comparisons.|ANCOVA||Mean Difference = 20 mg Tadalafil minus Placebo|||-0.06|-0.47|0.012
72628488|NCT02921789|144784897|SUPERIORITY||Difference|5.0||||0.7597|TWO_SIDED|95.0|-18.9|29.0||Incidence rate comparisons are based on Fisher's Exact test and confidence intervals are based on Normal Approximation.|Fisher Exact|||Month 12||29.0|-18.9|0.7597
72628489|NCT02921789|144784898|SUPERIORITY||Difference|-0.3||||1||95.0|-24.9|24.3||Incidence rate comparisons are based on Fisher's Exact test and confidence intervals are based on Normal Approximation.|Fisher Exact|||||24.3|-24.9|1.0
72628490|NCT02921789|144784899|SUPERIORITY||Difference|-3.9||||1||95.0|-30.2|22.4||Incidence rate comparisons are based on Fisher's Exact test and confidence intervals are based on Normal Approximation.|Fisher Exact|||Month 3||22.4|-30.2|1.0
72628491|NCT02921789|144784899|SUPERIORITY||Difference|-6.2||||0.772||95.0|-31.7|19.3||Incidence rate comparisons are based on Fisher's Exact test and confidence intervals are based on Normal Approximation.|Fisher Exact|||Month 6||19.3|-31.7|0.7720
72577233|NCT00384930|144681098|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.26||||0.029||95.0|-0.49|-0.03||P-value for Change from Baseline. Change=Endpoint - Baseline. P-values from ANCOVA model with effect of treatment group, geographic region, and baseline value of analyzed variable as a covariate, and were not adjusted for multiple comparisons.|ANCOVA||Mean Difference = 2.5 mg Tadalafil minus Placebo|||-0.03|-0.49|0.029
72628492|NCT02921789|144784899|SUPERIORITY||Difference|-7.5||||0.772||95.0|-32.6|17.6||Incidence rate comparisons are based on Fisher's Exact test and confidence intervals are based on Normal Approximation.|Fisher Exact|||Month 12||17.6|-32.6|0.7720
72628493|NCT01766102|144784908|OTHER|||||||0.716|||||||t-test, 2 sided|||H0: Procedure time is not significantly different based on mammography type used||||0.716
72628494|NCT01766102|144784908|OTHER|||||||0.676|||||||t-test, 2 sided|||H0: Operating room time is not significantly different based on mammography type used||||0.676
72577234|NCT00384930|144681098|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.37||||0.002||95.0|-0.6|-0.14||P-value for Change from Baseline. Change=Endpoint - Baseline. P-values from ANCOVA model with effect of treatment group, geographic region, and baseline value of analyzed variable as a covariate, and were not adjusted for multiple comparisons.|ANCOVA||Mean Difference = 5 mg Tadalafil minus Placebo|||-0.14|-0.60|0.002
72577235|NCT00384930|144681098|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.43|||<|0.001||95.0|-0.66|-0.19||P-value for Change from Baseline. Change=Endpoint - Baseline. P-values from ANCOVA model with effect of treatment group, geographic region, and baseline value of analyzed variable as a covariate, and were not adjusted for multiple comparisons.|ANCOVA||Mean Difference = 10 mg Tadalafil minus Placebo|||-0.19|-0.66|<0.001
72577236|NCT00384930|144681098|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.4|||<|0.001||95.0|-0.64|-0.17||P-value for Change from Baseline. Change=Endpoint - Baseline. P-values from ANCOVA model with effect of treatment group, geographic region, and baseline value of analyzed variable as a covariate, and were not adjusted for multiple comparisons.|ANCOVA||Mean Difference = 20 mg Tadalafil minus Placebo|||-0.17|-0.64|<0.001
72577237|NCT00384930|144681099|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.13||||0.583||95.0|-0.58|0.33||P-value for Change from Baseline. Change=Endpoint - Baseline. P-values from ANCOVA model with effect of treatment group, geographic region, and baseline value of analyzed variable as a covariate, and were not adjusted for multiple comparisons.|ANCOVA||Mean Difference = 2.5 mg Tadalafil minus Placebo|||0.33|-0.58|0.583
72577238|NCT00384930|144681099|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.57||||0.013||95.0|-1.03|-0.12||P-value for Change from Baseline. Change=Endpoint - Baseline. P-values from ANCOVA model with effect of treatment group, geographic region, and baseline value of analyzed variable as a covariate, and were not adjusted for multiple comparisons.|ANCOVA||Mean Difference = 5 mg Tadalafil minus Placebo|||-0.12|-1.03|0.013
72577239|NCT00384930|144681099|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.55||||0.016||95.0|-1.0|-0.1||P-value for Change from Baseline. Change=Endpoint - Baseline. P-values from ANCOVA model with effect of treatment group, geographic region, and baseline value of analyzed variable as a covariate, and were not adjusted for multiple comparisons.|ANCOVA||Mean Difference = 10 mg Tadalafil minus Placebo|||-0.10|-1.00|0.016
72628495|NCT03423602|144784910|NON_INFERIORITY|Based on a Meta-Analysis of a focused systematic literature review from a comparable patient population, the estimated major vascular access site complication rate or PGsafety for the conservative Random Effect Model is 0.125 with a 95% Confidence Interval of 0.09 to 0.17. Given that the upper bound was 0.17 this justified the use of 0.13 as a valid PGsafety plus a non-inferiority margin of 0.04 yielding an overall non-inferiority limit (NLs) of 0.17 for Safety. Study power is greater than 90%|Wilson's exact test|0.0487|||<|0.0001|ONE_SIDED|95.0||0.0487|||Wilson's exact test|All 75 enrolled subjects, regardless of their enrolment status at 1-month post implantation, including all reported safety data where included.||"The test for non-inferiority for safety was based on a one-sided test (at the 0.025 significance level) for a binomial proportion with hypotheses:~H0s: Psafety ≥ NLs versus H1s: Psafety \< NLs Where: Psafety is the actual proportion of device related major vascular access site complications within the study population; and NLs is the non-inferiority limit for proportion of expected major vascular access site complications associated with cut-down and suture closure."||0.0487||<.0001
72329432|NCT02574078|144184363|SUPERIORITY||Hazard Ratio (HR)|0.81||||0.4819|TWO_SIDED|95.0|0.46|1.45|||Unstratified log-rank|||||1.45|0.46|0.4819
72628496|NCT04790786|144784918|EQUIVALENCE|Equivalence between two arms was defined as 95% posterior probability the odds ratio is within a given bound.||||||||||||Equivalence between two arms was defined as 95% posterior probability the odds ratio is within a given bound based on Bayesian probability.|Bayesian cumulative logistic model|Bayesian cumulative logistic model, Equivalence between two arms was defined as 95% posterior probability the odds ratio is within a given bound.||The primary analysis model was a Bayesian cumulative logistic model that adjusted for treatment location (infusion center or ED), age (\<30, 30-39, 40-49, 50-59, 60-69, 70-79, and ≥ 80 years), sex, and time (2-week epochs). Comparisons between individual mAb were based on the relative odds ratio between a given two arms for the primary outcome. An odds ratio for an arm to a comparator \>1 implies improved outcomes. A sliding scale with different levels of equivalence bounds was pre-defined|Equivalence between two arms was defined as 95% posterior probability the odds ratio is within a given bound.|||
72628497|NCT02852967|144784938|SUPERIORITY|||||||0.6384|||||||Fisher Exact|||LOCF at 16 weeks (Double-blind Treatment Period): Fisher's Exact Method analysis of the percentage of subjects treated with belumosudil 200 mg QD + placebo (n = 23) who achieved PASI 75 compared to the percentage of subjects treated with placebo (n = 18) who achieved PASI 75.||||0.6384
72628498|NCT02852967|144784938|SUPERIORITY|||||||0.6419|||||||Fisher Exact|||LOCF at 16 weeks (Double-blind Treatment Period): Fisher's Exact Method analysis of the percentage of subjects treated with belumosudil 200 mg BID + placebo (n = 22) who achieved PASI 75 compared to the percentage of subjects treated with placebo (n = 18) who achieved PASI 75.||||0.6419
72577240|NCT00384930|144681099|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.62||||0.007||95.0|-1.08|-0.17||P-value for Change from Baseline. Change=Endpoint - Baseline. P-values from ANCOVA model with effect of treatment group, geographic region, and baseline value of analyzed variable as a covariate, and were not adjusted for multiple comparisons.|ANCOVA||Mean Difference = 20 mg Tadalafil minus Placebo|||-0.17|-1.08|0.007
72577241|NCT00384930|144681100|SUPERIORITY_OR_OTHER|||||||0.133||95.0||||P-values are from Cochran-Mantel-Haenszel test stratified by the randomization strata factors (4 geographic regions, 2 levels of IPSS severity, 2 levels of ED history) as fixed effect, and were not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|||||||0.133
72577242|NCT00384930|144681100|SUPERIORITY_OR_OTHER|||||||0.003||95.0||||P-values are from Cochran-Mantel-Haenszel test stratified by the randomization strata factors (4 geographic regions, 2 levels of IPSS severity, 2 levels of ED history) as fixed effect, and were not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|||||||0.003
72577243|NCT00384930|144681100|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values are from Cochran-Mantel-Haenszel test stratified by the randomization strata factors (4 geographic regions, 2 levels of IPSS severity, 2 levels of ED history) as fixed effect, and were not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|||||||<0.001
72577244|NCT00384930|144681100|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values are from Cochran-Mantel-Haenszel test stratified by the randomization strata factors (4 geographic regions, 2 levels of IPSS severity, 2 levels of ED history) as fixed effect, and were not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|||||||<0.001
72577245|NCT00384930|144681101|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.14||||0.735||95.0|-0.69|0.98||P-value for Change from Baseline. Change=Endpoint - Baseline. P-values from ANCOVA model with effect of treatment group, geographic region, and baseline value of analyzed variable as a covariate, and were not adjusted for multiple comparisons.|ANCOVA||Mean Difference = 2.5 mg Tadalafil minus Placebo|||0.98|-0.69|0.735
72577246|NCT00384930|144681101|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.39||||0.355||95.0|-0.44|1.23||P-value for Change from Baseline. Change=Endpoint - Baseline. P-values from ANCOVA model with effect of treatment group, geographic region, and baseline value of analyzed variable as a covariate, and were not adjusted for multiple comparisons.|ANCOVA||Mean Difference = 5 mg Tadalafil minus Placebo|||1.23|-0.44|0.355
72577247|NCT00384930|144681101|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.34||||0.433||95.0|-0.5|1.17||P-value for Change from Baseline. Change=Endpoint - Baseline. P-values from ANCOVA model with effect of treatment group, geographic region, and baseline value of analyzed variable as a covariate, and were not adjusted for multiple comparisons.|ANCOVA||Mean Difference = 10 mg Tadalafil minus Placebo|||1.17|-0.50|0.433
72577248|NCT00384930|144681101|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.74||||0.089||95.0|-0.11|1.59||P-value for Change from Baseline. Change=Endpoint - Baseline. P-values from ANCOVA model with effect of treatment group, geographic region, and baseline value of analyzed variable as a covariate, and were not adjusted for multiple comparisons.|ANCOVA||Mean Difference = 20 mg Tadalafil minus Placebo|||1.59|-0.11|0.089
72628499|NCT02852967|144784938|SUPERIORITY||||||>|0.9999|||||||Fisher Exact|||LOCF at 16 weeks (Double-blind Treatment Period): Fisher's Exact Method analysis of the percentage of subjects treated with belumosudil 400 mg QD + placebo (n = 21) who achieved PASI 75 compared to the percentage of subjects treated with placebo (n = 18) who achieved PASI 75.||||> 0.9999
72628500|NCT02852967|144784938|SUPERIORITY|||||||0.3859|||||||Fisher Exact|||LOCF at 16 weeks (Double-blind Treatment Period): Fisher's Exact Method analysis of the percentage of subjects treated with belumosudil 600 mg (n = 26) who achieved PASI 75 compared to the percentage of subjects treated with placebo (n = 18) who achieved PASI 75.||||0.3859
72628501|NCT02852967|144784938|SUPERIORITY|||||||0.4435|||||||Fisher Exact|||LOCF at 16 weeks (Double-blind Treatment Period): Fisher's Exact Method analysis of the percentage of all subjects treated with belumosudil (n = 92) who achieved PASI 75 compared to the percentage of subjects treated with placebo (n = 18) who achieved PASI 75||||0.4435
72577249|NCT00384930|144681102|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.36|||<|0.001||95.0|1.56|5.17||P-value for Change from Baseline. Change=Endpoint - Baseline. P-values from ANCOVA model with effect of treatment group, geographic region, and baseline value of analyzed variable as a covariate, and were not adjusted for multiple comparisons.|ANCOVA||Mean Difference = 2.5 mg Tadalafil minus Placebo|||5.17|1.56|<0.001
72577250|NCT00384930|144681102|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.75|||<|0.001||95.0|2.95|6.54||P-value for Change from Baseline. Change=Endpoint - Baseline. P-values from ANCOVA model with effect of treatment group, geographic region, and baseline value of analyzed variable as a covariate, and were not adjusted for multiple comparisons.|ANCOVA||Mean Difference = 5 mg Tadalafil minus Placebo|||6.54|2.95|<0.001
72329433|NCT02574078|144184363|SUPERIORITY||Hazard Ratio (HR)|0.31||||0.0241|TWO_SIDED|95.0|0.11|0.91|||Unstratified log-rank|||||0.91|0.11|0.0241
72628502|NCT02852967|144784938|SUPERIORITY|||||||0.2721|||||||Fisher Exact|||Observed at 16 weeks (Double-blind Treatment Period): Fisher's Exact Method analysis of the percentage of subjects treated with belumosudil 200 mg QD + placebo (n = 14) who achieved PASI 75 compared to the percentage of subjects treated with placebo (n = 10) who achieved PASI 75.||||0.2721
72628503|NCT02852967|144784938|SUPERIORITY|||||||0.3577|||||||Fisher Exact|||Observed at 16 weeks (Double-blind Treatment Period): Fisher's Exact Method analysis of the percentage of subjects treated with belumosudil 200 mg BID+ Placebo (n = 15) who achieved PASI 75 compared to the percentage of subjects treated with placebo (n = 10) who achieved PASI 75.||||0.3577
72628504|NCT02852967|144784938|SUPERIORITY||||||>|0.9999|||||||Fisher Exact|||Observed at 16 weeks (Double-blind Treatment Period): Fisher's Exact Method analysis of the percentage of subjects treated with belumosudil 500 mg QD + Placebo (n = 17) who achieved PASI 75 compared to the percentage of subjects treated with placebo (n = 10) who achieved PASI 75.||||> 0.9999
72628505|NCT02852967|144784938|SUPERIORITY|||||||0.3402|||||||Fisher Exact|||Observed at 16 weeks (Double-blind Treatment Period): Fisher's Exact Method analysis of the percentage of subjects treated with belumosudil 600 mg/day (n = 16) who achieved PASI 75 compared to the percentage of subjects treated with placebo (n = 10) who achieved PASI 75.||||0.3402
72628506|NCT02852967|144784938|SUPERIORITY|||||||0.3542|||||||Fisher Exact|||Observed at 16 weeks (Double-blind Treatment Period): Fisher's Exact Method analysis of the percentage of all subjects treated with belumosudil 200 mg QD + Placebo (n = 62) who achieved PASI 75 compared to the percentage of subjects treated with placebo (n = 10) who achieved PASI 75.||||0.3542
72628507|NCT02852967|144784942|SUPERIORITY|||||||0.5728|||||||Fisher Exact|||Percentage of subjects treated with belumosudil compared to placebo who had a PGA rating of clear or almost clear||||0.5728
72628508|NCT02852967|144784942|SUPERIORITY|||||||0.1962|||||||Fisher Exact|||Percentage of subjects treated with belumosudil compared to placebo who had a PGA rating of clear or almost clear||||0.1962
72628509|NCT02852967|144784942|SUPERIORITY|Percentage of subjects treated with belumosudil compared to placebo who had a PGA rating of clear or almost clear|||||>|0.9999|||||||Fisher Exact|||||||> 0.9999
72628510|NCT02852967|144784942|SUPERIORITY|||||||0.5583|||||||Fisher Exact|||Percentage of subjects treated with belumosudil compared to placebo who had a PGA rating of clear or almost clear||||0.5583
72628511|NCT02852967|144784942|SUPERIORITY|||||||0.2538|||||||Fisher Exact|||Percentage of subjects treated with belumosudil compared to placebo who had a PGA rating of clear or almost clear||||0.2538
72628512|NCT02286895|144784957|NON_INFERIORITY|The protocol stated that non-inferiority would be achieved if the lower limit of the 95% confidence interval (2-sided) for the difference in sero-conversion percentages (group receiving rotavirus minus group not receiving rotavirus) was \> -10%.|Mean Difference (Net)|0.1|||||TWO_SIDED|95.0|-4.0|4.2||||||Based on results from a prior study, the sponsor assumed 90% sero-conversion rates in each Arms A and B for each antigen in the two co-primary objectives. To rule out a non-inferiority margin of no more than 10% with 95% power (95% power was chosen to give an overall power of at least 90%) and a one-sided type-one error rate of no more than 2.5%, 237 evaluable subjects were required in each group to explore the co-primary objectives.||4.2|-4.0|
72628513|NCT02286895|144784958|NON_INFERIORITY|The protocol stated that non-inferiority would be achieved if the lower limit of the 95% CI (2-sided) for the difference in sero-conversion percentages (group receiving rotavirus minus group not receiving rotavirus) was \> -10%.|Mean Difference (Net)|-4.1|||||TWO_SIDED|95.0|-12.2|4.0||||||Based on results from a prior study completed by PATH and CVD-Mali, the sponsor assumed 90% sero-conversion rates in each Arms A and B for each antigen in the two co-primary objectives. To rule out a non-inferiority margin of no more than 10% with 95% power (95% power was chosen to give an overall power of at least 90%) and a one-sided type-one error rate of no more than 2.5%, 237 evaluable subjects were required in each group to explore the co-primary objectives.||4.0|-12.2|
72628514|NCT02286895|144784959|NON_INFERIORITY|The protocol stated that non-inferiority would be achieved if the lower limit of the 95% confidence interval (2-sided) for the difference in sero-conversion percentages (group receiving rotavirus minus group not receiving rotavirus) was \> -10%.|Mean Difference (Net)|-2.4|||||TWO_SIDED|95.0|-7.5|2.7||||||Based on results from a prior study completed by PATH and CVD-Mali, the sponsor assumed 90% sero-conversion rates in each Arms A and B for each antigen in the two co-primary objectives. To rule out a non-inferiority margin of no more than 10% with 95% power (95% power was chosen to give an overall power of at least 90%) and a one-sided type-one error rate of no more than 2.5%, 237 evaluable subjects were required in each group to explore the co-primary objectives.||2.7|-7.5|
72628515|NCT02286895|144784960|EQUIVALENCE|Definition of equivalence/null hypothesis: geometric mean titer (GMT) of group receiving rotavirus vaccine divided by GMT of group not receiving rotavirus vaccine = 1.|geometric mean titer ratio|0.9|||||TWO_SIDED|95.0|0.8|1.1||||||||1.1|0.8|
72628516|NCT02286895|144784961|EQUIVALENCE|Definition of equivalence/null hypothesis: geometric mean concentration (GMC) of group receiving rotavirus vaccine/ GMC of group not receiving rotavirus vaccine = 1|geometric mean titer ratio|-0.7|||||TWO_SIDED|95.0|-5.2|3.8||||||||3.8|-5.2|
72628517|NCT02286895|144784962|EQUIVALENCE|Definition of equivalence/null hypothesis: geometric mean titer (GMT) of group receiving rotavirus vaccine divided by GMT of group not receiving rotavirus vaccine = 1.|geometric mean titer ratio|0.9|||||TWO_SIDED|95.0|0.7|1.3||||||||1.3|0.7|
72628518|NCT02286895|144784963|SUPERIORITY||Mean Difference (Net)|17.5|||||TWO_SIDED|95.0|9.7|25.3||||||Null hypothesis: percentage of the seroresponse to rotavirus in the group that received rotavirus vaccine minus the percentage of the seroresponse to rotavirus in the group that did not receive rotavirus vaccine is less than or equal to 0.||25.3|9.7|
72628519|NCT02286895|144784964|SUPERIORITY||Mean Difference (Net)|15.8|||||TWO_SIDED|95.0|8.1|23.4||||||Null hypothesis: percentage of the seroresponse to rotavirus in the group that received rotavirus vaccine minus the percentage of the seroresponse to rotavirus in the group that did not receive rotavirus vaccine is less than or equal to 0.||23.4|8.1|
72628520|NCT02286895|144784965|SUPERIORITY||Mean Difference (Net)|25.4|||||TWO_SIDED|95.0|14.6|36.2||||||Null hypothesis: percentage of the seroresponse to rotavirus in the group that received rotavirus vaccine minus the percentage of the seroresponse to rotavirus in the group that did not receive rotavirus vaccine is less than or equal to 0.||36.2|14.6|
72628521|NCT02286895|144784966|SUPERIORITY||Mean Difference (Net)|31.1|||||TWO_SIDED|95.0|23.1|39.0||||||Null hypothesis: percentage of the seroresponse to rotavirus in the group that received rotavirus vaccine minus the percentage of the seroresponse to rotavirus in the group that did not receive rotavirus vaccine is less than or equal to 0.||39.0|23.1|
72329434|NCT02574078|144184363|SUPERIORITY||Hazard Ratio (HR)|1.59||||0.1401|TWO_SIDED|95.0|0.85|2.95|||Unstratified log-rank|||||2.95|0.85|0.1401
72329435|NCT02574078|144184367|SUPERIORITY||Hazard Ratio (HR)|0.73||||0.2862|TWO_SIDED|95.0|0.4|1.31|||Log Rank|stratified by Disease Status (Recurrent Locally Advanced vs. Metastatic), Performance Status (ECOG 0 vs.1 vs. 2) as entered into the IVRS||||1.31|0.40|0.2862
72577251|NCT00384930|144681102|SUPERIORITY_OR_OTHER||Mean Difference (Net)|5.83|||<|0.001||95.0|4.04|7.62||P-value for Change from Baseline. Change=Endpoint - Baseline. P-values from ANCOVA model with effect of treatment group, geographic region, and baseline value of analyzed variable as a covariate, and were not adjusted for multiple comparisons.|ANCOVA||Mean Difference = 10 mg Tadalafil minus Placebo|||7.62|4.04|<0.001
72577252|NCT00384930|144681102|SUPERIORITY_OR_OTHER||Mean Difference (Net)|6.15|||<|0.001||95.0|4.35|7.95||P-value for Change from Baseline. Change=Endpoint - Baseline. P-values from ANCOVA model with effect of treatment group, geographic region, and baseline value of analyzed variable as a covariate, and were not adjusted for multiple comparisons.|ANCOVA||Mean Difference = 20 mg Tadalafil minus Placebo|||7.95|4.35|<0.001
72577253|NCT00384930|144681103|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.58||||0.005||95.0|-2.68|-0.48||P-values are from an ANCOVA model with effect of treatment group, geographic region, and IPSS baseline value (at Visit 3) as a covariate, and were not adjusted for multiple comparisons.|ANCOVA||Mean Difference = 2.5 mg Tadalafil minus Placebo|This is a supportive analysis of the primary outcome.||-0.48|-2.68|0.005
72577254|NCT00384930|144681103|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.6|||<|0.001||95.0|-3.69|-1.51||P-values are from an ANCOVA model with effect of treatment group, geographic region, and IPSS baseline value (at Visit 3) as a covariate, and were not adjusted for multiple comparisons.|ANCOVA||Mean Difference = 5 mg Tadalafil minus Placebo|This is a supportive analysis of the primary outcome.||-1.51|-3.69|<0.001
72577255|NCT00384930|144681103|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.9|||<|0.001||95.0|-3.99|-1.81||P-values are from an ANCOVA model with effect of treatment group, geographic region, and IPSS baseline value (at Visit 3) as a covariate, and were not adjusted for multiple comparisons.|ANCOVA||Mean Difference = 10 mg Tadalafil minus Placebo|This is a supportive analysis of the primary outcome.||-1.81|-3.99|<0.001
72577256|NCT00384930|144681103|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.94|||<|0.001||95.0|-4.04|-1.84||P-values are from an ANCOVA model with effect of treatment group, geographic region, and IPSS baseline value (at Visit 3) as a covariate, and were not adjusted for multiple comparisons.|ANCOVA||Mean Difference = 20 mg Tadalafil minus Placebo|This is a supportive analysis of the primary outcome.||-1.84|-4.04|<0.001
72577257|NCT03968978|144681107|OTHER||Proportion|98.2|||||TWO_SIDED|95.0|93.67|99.5|||Score CI|CI at Week 0 (in clinic)||||99.5|93.67|
72577258|NCT03968978|144681107|OTHER||Proportion|100.0|||||TWO_SIDED|95.0|96.65|100.0|||Score CI|CI at Week 4 (in clinic)||||100|96.65|
72577259|NCT03968978|144681107|OTHER||Proportion|100.0|||||TWO_SIDED|95.0|96.63|100.0|||Score CI|CI for Week 8 (in clinic)||||100.00|96.63|
72577260|NCT03968978|144681107|OTHER||Proportion|100.0|||||TWO_SIDED|95.0|96.63|100.0|||Score CI|CI for Week 12 (at home)||||100.00|96.63|
72577261|NCT03968978|144681107|OTHER||Proportion|95.4|||||TWO_SIDED|95.0|89.71|98.02|||Score CI|CI for Week 16 (at home)||||98.02|89.71|
72577262|NCT03968978|144681107|OTHER||Proportion|96.3|||||TWO_SIDED|95.0|90.94|98.56|||Score CI|CI for Week 20 (in clinic)||||98.56|90.94|
72577263|NCT03968978|144681107|OTHER||Proportion|100.0|||||TWO_SIDED|95.0|96.47|100.0|||Score CI|CI for Week 0 (in clinic)||||100.00|96.47|
72577264|NCT03968978|144681107|OTHER||Proportion|97.1|||||TWO_SIDED|95.0|91.93|99.02|||Score CI|CI for Week 4 (in clinic)||||99.02|91.93|
72577265|NCT03968978|144681107|OTHER||Proportion|98.1|||||TWO_SIDED|95.0|93.32|99.48|||Score CI|CI for Week 8 (in clinic)||||99.48|93.32|
72577266|NCT03968978|144681107|OTHER||Proportion|99.0|||||TWO_SIDED|95.0|94.8|99.83|||Score CI|CI for week 12 (at home)||||99.83|94.80|
72577267|NCT03968978|144681107|OTHER||Proportion|97.1|||||TWO_SIDED|95.0|91.93|99.02|||Score CI|CI for Week 16 (at home)||||99.02|91.93|
72577268|NCT03968978|144681107|OTHER||Proportion|97.1|||||TWO_SIDED|95.0|91.93|99.02|||Score CI|CI for Week 20 (in clinic)||||99.02|91.93|
72577269|NCT03968978|144681108|OTHER||Proportion|98.2|||||TWO_SIDED|95.0|93.67|99.5|||Score CI|CI at Week 0 (in clinic)||||99.50|93.67|
72577270|NCT03968978|144681108|OTHER||Proportion|100.0|||||TWO_SIDED|95.0|96.65|100.0|||Score CI|CI at Week 4 (in clinic)||||100.00|96.65|
72577271|NCT03968978|144681108|OTHER||Proportion|100.0|||||TWO_SIDED|95.0|96.63|100.0|||Score CI|CI for Week 8 (in clinic)||||100.00|96.63|
72577272|NCT03968978|144681108|OTHER||Proportion|100.0|||||TWO_SIDED|95.0|96.63|100.0|||Score CI|CI for Week 12 (at home)||||100.00|96.63|
72577273|NCT03968978|144681108|OTHER||Proportion|97.2|||||TWO_SIDED|95.0|92.8|99.04|||Score CI|CI for Week 16 (at home)||||99.04|92.80|
72577274|NCT03968978|144681108|OTHER||Proportion|99.1|||||TWO_SIDED|95.0|94.85|99.83|||Score CI|CI for Week 20 (in clinic)||||99.83|94.85|
72577275|NCT03968978|144681108|OTHER||Proportion|100.0|||||TWO_SIDED|95.0|96.46|100.0|||Score CI|CI for Week 0 (in clinic)||||100.00|96.46|
72577276|NCT03968978|144681108|OTHER||Proportion|97.2|||||TWO_SIDED|95.0|93.38|99.48|||Score CI|CI for Week 4 (in clinic)||||99.48|93.38|
72577277|NCT03968978|144681108|OTHER||Proportion|98.1|||||TWO_SIDED|95.0|93.32|99.48|||Other CI|CI for Week 8 (in clinic)||||99.48|93.32|
72577278|NCT03968978|144681108|OTHER||Proportion|100.0|||||TWO_SIDED|95.0|96.44|100.0|||Score CI|CI for week 12 (at home)||||100.00|96.44|
72577279|NCT03968978|144681108|OTHER||Proportion|100.0|||||TWO_SIDED|95.0|96.37|100.0|||Score CI|CI for Week 16 (at home)||||100.00|96.37|
72577280|NCT03968978|144681108|OTHER||Proportion|100.0|||||TWO_SIDED|95.0|96.37|100.0|||Score CI|CI for Week 20 (in clinic)||||100.00|96.37|
72577281|NCT03968978|144681109|OTHER||Proportion|1.8|||||TWO_SIDED|95.0|0.5|6.33|||Score CI|CI at Week 0 (in clinic)||||6.33|0.50|
72577282|NCT03968978|144681109|OTHER||Proportion|0.0|||||TWO_SIDED|95.0|0.0|3.35|||Score CI|CI at Week 4 (in clinic)||||3.35|0|
72577283|NCT03968978|144681109|OTHER||Proportion|0.0|||||TWO_SIDED|95.0|0.0|3.37|||Score CI|CI for Week 8 (in clinic)||||3.37|0|
72577284|NCT03968978|144681109|OTHER||Proportion|0.0|||||TWO_SIDED|95.0|0.0|3.37|||Score CI|CI for Week 12 (at home)||||3.37|0|
72577285|NCT03968978|144681109|OTHER||Proportion|2.8|||||TWO_SIDED|95.0|0.96|7.92|||Score CI|CI for Week 16 (at home)||||7.92|0.96|
72577286|NCT03968978|144681109|OTHER||Proportion|0.9|||||TWO_SIDED|95.0|0.17|5.15|||Score CI|CI for Week 20 (in clinic)||||5.15|0.17|
72577287|NCT03968978|144681109|SUPERIORITY||Proportion|0.0|||||TWO_SIDED|95.0|0.0|3.53|||Score CI|CI for Week 0 (in clinic)||||3.53|0|
72410324|NCT04278417|144329041|NON_INFERIORITY|Non-inferiority of brolucizumab to PRP with respect to change from baseline in BCVA at Week 54, considering a non-inferiority margin of 4 ETDRS letters. Assuming that the BCVA changes follow a normal distribution with equal means between treatments, and a common standard deviation of 10 letters, for a one-sided alpha level of 0.025, with 300 subjects per arm there is \>99% power to reject the null hypothesis that brolucizumab 6 mg is inferior to PRP.|LS mean difference|4.4|STANDARD_ERROR_OF_MEAN|1.03|<|0.001|TWO_SIDED|95.0|2.4|6.4|||ANCOVA|||1||6.4|2.4|<0.001
72410325|NCT04278417|144329041|SUPERIORITY||||||<|0.001|||||||ANCOVA|||2||||<0.001
72410326|NCT04278417|144329042|SUPERIORITY||Difference in % of Participants|39.4|||<|0.001|TWO_SIDED|95.0|32.0|46.8|||Cochran-Mantel-Haenszel|||||46.8|32.0|< 0.001
72410327|NCT04278417|144329044|SUPERIORITY||Difference in % of Participants|-41.1|||<|0.001|TWO_SIDED|95.0|-48.0|-34.2|||Cochran-Mantel-Haenszel|||||-34.2|-48.0|< 0.001
72410328|NCT04278417|144329047|SUPERIORITY||Difference in % of Participants|26.4|||<|0.001|TWO_SIDED|95.0|19.5|33.3|||Cochran-Mantel-Haenszel|||Week 54||33.3|19.5|<0.001
72410329|NCT01331694|144329062|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.64||||||95.0|1.5|1.79|||||Hazard ratio for hospitalization or emergency department visit for IP compared to FSC; HR estimate adjusted for age, sex, geographic region, pre-initial treatment comorbidities, and COPD-related utilization|||1.79|1.50|
72410330|NCT01331694|144329062|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.29||||||95.0|1.17|1.41|||||Hazard ratio for hospitalization or emergency department visit for TIO compared to FSC; HR estimate adjusted for age, sex, geographic region, pre-initial treatment comorbidities, and COPD-related utilization|||1.41|1.17|
72410331|NCT01331694|144329062|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.78||||||95.0|1.59|2.0|||||Hazard ratio for emergency department visit for IP compared to FSC; HR estimate adjusted for age, sex, geographic region, pre-initial treatment comorbidities, and COPD-related utilization|||2.00|1.59|
72410332|NCT01331694|144329062|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.33||||||95.0|1.17|1.51|||||Hazard ratio for emergency department visit for TIO compared to FSC; HR estimate adjusted for age, sex, geographic region, pre-initial treatment comorbidities, and COPD-related utilization|||1.51|1.17|
72410333|NCT01331694|144329062|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.65||||||95.0|1.41|1.94|||||Hazard ratio for outpatient visit with oral steroid fill for IP compared to FSC; HR estimate adjusted for age, sex, geographic region, pre-initial treatment comorbidities, and COPD-related utilization|||1.94|1.41|
72410334|NCT01331694|144329062|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.49||||||95.0|1.26|1.76|||||Hazard ratio for outpatient visit with oral steroid fill for TIO compared to FSC; HR estimate adjusted for age, sex, geographic region, pre-initial treatment comorbidities, and COPD-related utilization|||1.76|1.26|
72410335|NCT01331694|144329062|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.39||||||95.0|1.23|1.57|||||Hazard ratio for outpatient visit with antibiotic fill for IP compared to FSC; HR estimate adjusted for age, sex, geographic region, pre-initial treatment comorbidities, and COPD-related utilization|||1.57|1.23|
72410336|NCT01331694|144329062|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.33||||||95.0|1.17|1.51|||||Hazard ratio for outpatient visit with antibiotic fill for TIO compared to FSC; HR estimate adjusted for age, sex, geographic region, pre-initial treatment comorbidities, and COPD-related utilization|||1.51|1.17|
72410337|NCT00983580|144329065|SUPERIORITY|||||||0.448|||||||Chi-squared|||||||0.448
72410338|NCT00983580|144329066|SUPERIORITY|||||||0.358|||||||Wilcoxon (Mann-Whitney)|||This statistical analysis compares the difference between the number of patients with No adenoma recurrence at 12 months with those with adenoma recurrence at 12 months.||||0.358
72410339|NCT00983580|144329068|SUPERIORITY|||||||0.513|||||||t-test, 2 sided|||||||0.513
72410340|NCT01652716|144329074|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.37|STANDARD_ERROR_OF_MEAN|0.1349||0.0072|TWO_SIDED|95.0|-0.63|-0.1|||Mixed model for repeated measure (MMRM)|Based on a repeated measures mixed model including fixed categorical effects of treatment||||-0.10|-0.63|0.0072
72410341|NCT01652716|144329075|SUPERIORITY_OR_OTHER|||||||0.2247|||||||Cochran-Mantel-Haenszel|||||||0.2247
72410342|NCT01652716|144329076|SUPERIORITY_OR_OTHER||LS Mean Difference|-10.2|STANDARD_ERROR_OF_MEAN|5.841||0.1656|TWO_SIDED|95.0|-21.7|1.3||Adjusted|Cochran-Mantel-Haenszel|||||1.3|-21.7|0.1656
72410343|NCT01652716|144329077|SUPERIORITY_OR_OTHER||LS Mean Difference|0.4|STANDARD_ERROR_OF_MEAN|0.4497||0.3744|TWO_SIDED|95.0|-0.48|1.28|||Cochran-Mantel-Haenszel|||||1.28|-0.48|0.3744
72410344|NCT01652716|144329078|SUPERIORITY_OR_OTHER||LS Mean Difference|26.74|STANDARD_ERROR_OF_MEAN|15.8957||0.0985|TWO_SIDED|95.0|-5.16|58.64|||Cochran-Mantel-Haenszel|||||58.64|-5.16|0.0985
72410345|NCT00594256|144329135|SUPERIORITY_OR_OTHER||||||=|0.002||95.0|||||t-test, 2 sided|||Open label baseline final paired t test||||=0.002
72410346|NCT00594256|144329136|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||t-test, 2 sided|||Open label baseline final paired t test||||0.02
72410347|NCT00594256|144329137|SUPERIORITY_OR_OTHER|||||||0.04||95.0|||||t-test, 2 sided|||Open label baseline final paired t test||||0.04
72410348|NCT00594256|144329138|SUPERIORITY_OR_OTHER|||||||0.8||95.0|||||t-test, 2 sided|||Open label baseline final paired t test||||0.8
72410349|NCT00594256|144329139|SUPERIORITY_OR_OTHER||||||<|0.01||95.0|||||t-test, 1 sided|||Open label baseline final paired t test||||<0.01
72410350|NCT04160260|144329140|EQUIVALENCE|Omadacycline 300 mg PO provided equivalent total exposure as measured by AUC relative to omadacycline 100 mg IV.|Geometric Mean Ratio|95.17|||||TWO_SIDED|90.0|84.2|107.5|||||A t-test on the natural log-transformed PK parameter AUC(0-48) was performed to obtain the Geometric Mean Ratio and its confidence interval.|Comparison was performed with the 100 mg intravenous (IV) omadacycline treatment group (data were obtained from 6 completed studies-NCT numbers not available). Using the Day 1 plasma concentration profile of the 100 mg IV QD dosing from these studies, a BID dosing on Day 1 and a QD dosing on Day 2 was simulated using the superposition principle. Log Geometric Mean (GM) AUC(0-48) of omadacycline for the 100 mg IV omadacycline group was as follows:Participants analyzed=63; GM (SD)=9.98 (0.2091).||107.5|84.2|
72421502|NCT01342458|144354197|SUPERIORITY_OR_OTHER|||||||0.006|TWO_SIDED||||||Mixed Models Analysis|||Sample size was calculated based on pain WOMAC score and was accomplished using a moderate effect size (f=0.30). Standard deviation estimates were taken from our previous study. A sample size of 56 patients was needed to provide 80% power for detecting a moderate effect difference between the highest and lowest group pain means, with an alpha level of 0.05, a statistical design of F test of repeated measures (between and within effects), and assuming a 10% loss to follow-up.||||0.006
72410351|NCT04160260|144329141|EQUIVALENCE|Omadacycline 300 mg PO provided equivalent total exposure as measured by AUC relative to omadacycline 100 mg IV.|Geometric Mean Ratio|100.8|||||TWO_SIDED|90.0|88.0|115.5|||||A t-test on the natural log-transformed PK parameter AUC(0-24) was performed to obtain the Geometric Mean Ratio and its confidence interval.|Comparison was performed with the 100 mg IV omadacycline treatment group (data were obtained from 6 completed studies-NCT numbers not available). Using the Day 1 plasma concentration profile of the 100 mg IV QD dosing from these studies, a BID dosing on Day 1 and a QD dosing on Day 2 was simulated using the superposition principle. Log GM AUC(0-24) of omadacycline for the 100 mg IV omadacycline group was as follows:Participants analyzed=63; GM (SD)=9.26 (0.1985).||115.5|88.0|
72410352|NCT01612546|144329168|OTHER||||||<|0.01|||||||Fisher Exact|||||||<0.01
72410353|NCT02276495|144329173|SUPERIORITY|||||||0.668|||||||Kruskal-Wallis|||||||0.668
72410354|NCT02276495|144329174|SUPERIORITY|||||||0.006|||||||Kruskal-Wallis|||||||0.006
72410355|NCT02276495|144329175|SUPERIORITY|||||||0.013|||||||Kruskal-Wallis|||||||0.013
72410356|NCT00612313|144329181|SUPERIORITY_OR_OTHER||Difference in percentages|9.7||||0.02|TWO_SIDED|||||The estimated rate of time spent well was evaluated using a Poisson regression with adjustment for CDRS-R score at the end of the acute phase, age group, and gender.|Regression, Poisson||Differencein percentages represents estimated percentage for medication management + CBT Arm minus estimated percentage for medication management only Arm.|||||.02
72421503|NCT01342458|144354197|SUPERIORITY_OR_OTHER||Effect Size|1.46|||<|0.001|TWO_SIDED||||||post hoc newman keuls|||From baseline to 3rd month.||||<0.001
72421504|NCT01342458|144354197|SUPERIORITY_OR_OTHER||Effect size|1.94|||<|0.001|TWO_SIDED||||||post hoc Newman Keuls|||From baseline to 6th month.||||<0.001
72410357|NCT01016834|144329185|SUPERIORITY_OR_OTHER|||||||0.0007|||||||t-test, 2 sided|||For the primary analyses and other PPMQ-R variables, the mean of the differences between each subject's rating of overall treatment satisfaction at the end of study based on the subject's experience using Sumavel DosePro and the rating at baseline based on the subject's pre-study triptan treatment were compared using a two-sided paired t-test at the 5% level of significance||||0.0007
72410358|NCT01694706|144329195|NON_INFERIORITY_OR_EQUIVALENCE|no formal testing, investigation of bioavailability|Geometric Mean Ratio|120.35|STANDARD_DEVIATION|23.2||0.342|TWO_SIDED|90.0|102.09|141.88|||ANOVA|Ratio calculated as Faldaprevir after a high-fat meal divided by Faldaprevir in fasting|Standard deviation is actually the geometric coefficient of variation (gCV)|||141.88|102.09|0.3420
72410359|NCT01694706|144329195|NON_INFERIORITY_OR_EQUIVALENCE|no formal testing, investigation of bioavailability|Geometric Mean Ratio|94.33|STANDARD_DEVIATION|30.8||0.0962|TWO_SIDED|90.0|76.21|116.76|||ANOVA|Ratio calculated as Faldaprevir and Omeprazole divided by Faldaprevir in fasting|Standard deviation is actually the geometric coefficient of variation (gCV)|||116.76|76.21|0.0962
72410360|NCT01694706|144329196|NON_INFERIORITY_OR_EQUIVALENCE|no formal testing, investigation of bioavailability|Geometric Mean Ratio|118.79|STANDARD_DEVIATION|52.4||0.3993|TWO_SIDED|90.0|83.19|169.628|||ANOVA|Ratio calculated as Faldaprevir after a high-fat meal divided by Faldaprevir in fasting|Standard deviation is actually the geometric coefficient of variation (gCV)|||169.628|83.190|0.3993
72410361|NCT01694706|144329196|NON_INFERIORITY_OR_EQUIVALENCE|no formal testing, investigation of bioavailability|Geometric Mean Ratio|93.55|STANDARD_DEVIATION|53.0||0.2204|TWO_SIDED|90.0|65.783|133.03|||ANOVA|Ratio calculated as Faldaprevir and Omeprazole divided by Faldaprevir in fasting|Standard deviation is actually the geometric coefficient of variation (gCV)|||133.030|65.783|0.2204
72410362|NCT01694706|144329197|NON_INFERIORITY_OR_EQUIVALENCE|no formal testing, investigation of bioavailability|Geometric Mean Ratio|121.28|STANDARD_DEVIATION|24.0||0.3765|TWO_SIDED|90.0|102.32|143.74|||ANOVA|Ratio calculated as Faldaprevir after a high-fat meal divided by Faldaprevir in fasting|Standard deviation is actually the geometric coefficient of variation (gCV)|||143.74|102.32|0.3765
72410363|NCT01694706|144329197|NON_INFERIORITY_OR_EQUIVALENCE|no formal testing, investigation of bioavailability|Geometric Mean Ratio|94.72|STANDARD_DEVIATION|31.4||0.0946|TWO_SIDED|90.0|76.25|117.67|||ANOVA|Ratio calculated as Faldaprevir and Omeprazole divided by Faldaprevir in fasting|Standard deviation is actually the geometric coefficient of variation (gCV)|||117.67|76.25|0.0946
72410364|NCT02652780|144329206|SUPERIORITY||Mean Difference (Net)|-0.008||||0.8783|TWO_SIDED|95.0|-0.119|0.102|||ANCOVA|||A mixed model of analysis of covariance (ANCOVA) was used with change from baseline at Week 48 as the response, and participants, eyes of the participant as random factor, treatment and baseline LogMAR value as covariates in the model. P-value is used to assess the significance of the difference between All-GS010 and All-Sham with respect to change of LogMAR from baseline.||0.102|-0.119|0.8783
72410365|NCT01172938|144329218|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|19.0||||0.0001|TWO_SIDED|95.0|9.7|28.3|||Cochran-Mantel-Haenszel|2-sided p-value is based on the Cochran-Mantel-Haenszel (CMH) test adjusting for baseline disease modifying antirheumatic drug (DMARD) use.|Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the CMH weights. The 2-sided 95% confidence interval (CI) is based on a normal approximation to the weighted average.|In order to maintain the Type 1 error at the 0.05 significance level, the Hochberg procedure was to be used. The results of the endpoint were to be considered statistically significant if both the 30 mg apremilast dose versus placebo comparison and the 20 mg versus placebo comparison were statistically significant at the 0.05 significance level, or one of the comparisons was statistically significant at the 0.025 level.||28.3|9.7|0.0001
72410366|NCT01172938|144329218|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|11.3||||0.0166|TWO_SIDED|95.0|2.2|20.4|||Cochran-Mantel-Haenszel|2-sided p-value is based on the CMH test adjusting for baseline DMARD use.|Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the CMH weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|In order to maintain the Type 1 error at the 0.05 significance level, the Hochberg procedure was to be used. The results of the endpoint were to be considered statistically significant if both the 30 mg apremilast dose versus placebo comparison and the 20 mg versus placebo comparison were statistically significant at the 0.05 significance level, or one of the comparisons was statistically significant at the 0.025 level.||20.4|2.2|0.0166
72410367|NCT01172938|144329219|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.159||||0.0017|TWO_SIDED|95.0|-0.258|-0.06|||ANCOVA|Based on an ANCOVA model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.||Pairwise comparisons (30 mg vs placebo and 20 mg vs placebo) were conducted conditional on the primary endpoint results. If the primary endpoint was statistically significant for both apremilast dose groups, pairwise comparisons for the HAQ-DI were to be evaluated at the 0.05 level using the Hochberg procedure. If only one apremilast dose was statistically significant, then only the comparison between that apremilast dose and placebo was conducted for the HAQ-DI score, at the 0.025 level.||-0.060|-0.258|0.0017
72421505|NCT01342458|144354197|SUPERIORITY_OR_OTHER||Effect size|0.82||||0.001|TWO_SIDED||||||post hoc Newman-Keuls|||From baseline to 3rd month.||||0.001
72421506|NCT01342458|144354197|SUPERIORITY_OR_OTHER||Effect size|0.66|||<|0.001|TWO_SIDED||||||post hoc Newman-Keuls|||From baseline to 6th month.||||<0.001
72577288|NCT03968978|144681109|OTHER||Proportion|2.8|||||TWO_SIDED|95.0|0.97|7.99|||Score CI|CI for Week 4 (in clinic)||||7.99|0.97|
72577289|NCT03968978|144681109|OTHER||Proportion|1.9|||||TWO_SIDED|95.0|0.52|6.68|||Other CI|CI for Week 8 (in clinic)||||6.68|0.52|
72628522|NCT02286895|144784967|SUPERIORITY||Mean Difference (Net)|17.7|||||TWO_SIDED|95.0|12.0|23.5||||||Null hypothesis: percentage of the seroresponse to rotavirus in the group that received rotavirus vaccine minus the percentage of the seroresponse to rotavirus in the group that did not receive rotavirus vaccine is less than or equal to 0.||23.5|12.0|
72628523|NCT02286895|144784968|SUPERIORITY||Mean Difference (Net)|52.0|||||TWO_SIDED|95.0|37.7|66.3||||||Null hypothesis: percentage of the seroresponse to rotavirus in the group that received rotavirus vaccine minus the percentage of the seroresponse to rotavirus in the group that did not receive rotavirus vaccine is less than or equal to 0.||66.3|37.7|
72628524|NCT02286895|144784969|SUPERIORITY||geometric mean titer ratio|1.7|||||TWO_SIDED|95.0|1.2|2.4||||||Null hypothesis: geometric mean titer (GMT) in group receiving rotavirus vaccine/GMT in group not receiving rotavirus vaccine ≤ 1||2.4|1.2|
72628525|NCT02286895|144784970|SUPERIORITY||geometric mean titer ratio|2.3|||||TWO_SIDED|95.0|1.7|3.1||||||Null hypothesis: 28 days post-vaccination, geometric mean titer (GMT) in group receiving rotavirus vaccine/GMT in group not receiving rotavirus vaccine ≤ 1||3.1|1.7|
72628526|NCT02286895|144784971|SUPERIORITY||geometric mean titer ratio|2.0|||||TWO_SIDED|95.0|1.2|3.3||||||Null hypothesis: geometric mean titer (GMT) in group receiving rotavirus vaccine/GMT in group not receiving rotavirus vaccine ≤ 1||3.3|1.2|
72628527|NCT02286895|144784972|SUPERIORITY||geometric mean titer ratio|4.6|||||TWO_SIDED|95.0|2.4|8.9||||||Null hypothesis: geometric mean titer (GMT) in group receiving rotavirus vaccine/GMT in group not receiving rotavirus vaccine ≤ 1||8.9|2.4|
72628528|NCT01073293|144784991|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority of concomitant versus non-concomitant vaccination is demonstrated if the lower limit of the 95% confidence interval for the fold difference is \>0.5|Fold difference in GMT|0.95|||<|0.001|TWO_SIDED|95.0|0.86|1.05|||ANOVA|||Anti-HPV 6||1.05|0.86|<0.001
72628529|NCT01073293|144784991|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority of concomitant versus non-concomitant vaccination is demonstrated if the lower limit of the 95% confidence interval for the fold difference is \>0.5|Fold difference in GMT|0.97|||<|0.001|TWO_SIDED|95.0|0.87|1.07|||ANOVA|||Anti-HPV 11||1.07|0.87|<0.001
72628530|NCT01073293|144784991|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority of concomitant versus non-concomitant vaccination is demonstrated if the lower limit of the 95% confidence interval for the fold difference is \>0.5|Fold difference in GMT|0.94|||<|0.001|TWO_SIDED|95.0|0.85|1.04|||ANOVA|||Anti-HPV 16||1.04|0.85|<0.001
72628531|NCT01073293|144784991|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority of concomitant versus non-concomitant vaccination is demonstrated if the lower limit of the 95% confidence interval for the fold difference is \>0.5|Fold difference in GMT|0.95|||<|0.001|TWO_SIDED|95.0|0.84|1.07|||ANOVA|||Anti-HPV 18||1.07|0.84|<0.001
72628532|NCT01073293|144784991|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority of concomitant versus non-concomitant vaccination is demonstrated if the lower limit of the 95% confidence interval for the fold difference is \>0.5|Fold difference in GMT|0.94|||<|0.001|TWO_SIDED|95.0|0.84|1.06|||ANOVA|||Anti-HPV 31||1.06|0.84|<0.001
72628533|NCT01073293|144784991|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority of concomitant versus non-concomitant vaccination is demonstrated if the lower limit of the 95% confidence interval for the fold difference is \>0.5|Fold difference in GMT|0.9|||<|0.001|TWO_SIDED|95.0|0.81|1.0|||ANOVA|||Anti-HPV 33||1.00|0.81|<0.001
72577290|NCT03968978|144681109|OTHER||Proportion|0.0|||||TWO_SIDED|95.0|0.0|3.56|||Score CI|CI for week 12 (at home)||||3.56|0|
72577291|NCT03968978|144681109|OTHER||Proportion|0.0|||||TWO_SIDED|95.0|0.0|3.63|||Score CI|CI for Week 16 (at home)||||3.63|0|
72577292|NCT03968978|144681109|OTHER||Proportion|0.0|||||TWO_SIDED|95.0|0.0|3.63|||Score CI|CI for Week 20 (in clinic)||||3.63|0|
72577293|NCT00070499|144681160|SUPERIORITY_OR_OTHER_LEGACY|||||||0.073||95.0|||||Fisher Exact|||||||0.073
72577294|NCT00070499|144681160|SUPERIORITY_OR_OTHER_LEGACY|||||||0.31||95.0|||||Fisher Exact|||||||0.31
72577295|NCT00070499|144681162|SUPERIORITY_OR_OTHER_LEGACY|||||||0.29||95.0|||||Log Rank|||Log-rank test of overall survival||||0.29
72577296|NCT00070499|144681162|SUPERIORITY_OR_OTHER_LEGACY|||||||0.55||95.0|||||Log Rank|||Log-rank test of overall survival||||0.55
72577297|NCT00070499|144681163|SUPERIORITY_OR_OTHER_LEGACY|||||||0.074||95.0|||||Log Rank|||Log-rank test of relapse-free survival||||0.074
72577298|NCT00070499|144681163|SUPERIORITY_OR_OTHER_LEGACY|||||||0.29||95.0|||||Log Rank|||Log-rank test of relapse-free survival||||0.29
72577299|NCT02883049|144681165|SUPERIORITY||Hazard Ratio (HR)|1.022||||0.893|TWO_SIDED|95.0|0.74|1.413|||Log Rank||Hazard ratio = hazard rate for Arm B/hazard rate for Arm A|To compare the DFS of the randomized patients on HR B-ALL Arm A vs Arm B. With a total of 1800 patients accrued over 5 years with minimum follow up of 2 years, randomized 1:1 to the 2 arms, we will be able to detect an improvement in 5-year DFS from 90% to 94 (HR=0.5873) between IT MTX and ITT based regimens (2-sided log rank test, alpha=5%), with 84.2% power.||1.413|0.74|0.893
72577300|NCT02883049|144681166|SUPERIORITY||Hazard Ratio (HR)|1.019||||0.556|ONE_SIDED|97.5||1.335|||Log Rank||Hazard ratio = hazard rate for Experimental Arm 1 /hazard rate for Control Arm|To compare the DFS of the randomized patients on Control Arm vs. Experimental Arm 1. This study design will have 86.8% power (1-sided log rank test, adjusted alpha=0.025 for multiple comparisons) to detect an improvement in 4-year DFS from 70% to 79% (HR=0.661) between the control arm and the experimental arm.||1.335||0.556
72577301|NCT00826007|144681203|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.18|STANDARD_ERROR_OF_MEAN|0.36|<|0.001|TWO_SIDED|95.0|0.09|0.18|||Regression, Logistic|||||.18|.09|<0.001
72577302|NCT01392963|144681208|OTHER|||||||0.001|||||||Mixed Models Analysis|||||||0.001
72577303|NCT00369486|144681210|SUPERIORITY_OR_OTHER|||||||0.46||95.0||||Adjusted for baseline central subfield thickness|repeated measures least sq. regression|Models adjusted for baseline values and for correlated data from subjects with two study eyes.||Comparison of change in central subfield thickening from baseline to 34 weeks in all five groups.||||0.46
72577304|NCT00369486|144681211|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.5||||0.04||95.0|0.2|1.0|||generalized estimating equations|||Analysis combined posterior and anterior injection + laser groups to compare with laser only.||1.0|0.2|0.04
72577305|NCT00369486|144681211|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.2||||0.63||95.0|0.5|2.9|||generalized estimating equations|||Analysis combined posterior and anterior injection only groups to compare with laser only treatment group.||2.9|0.5|0.63
72577306|NCT00369486|144681212|SUPERIORITY_OR_OTHER|||||||0.94||95.0|||||repeated measures least sq. regression|Adjusted for baseline values and for the correlated data from subjects with two study eyes.||Comparison of the mean change in visual acuity letter score among the five groups at 34 weeks. Negative changes represent a worsening in visual acuity.||||0.94
72577307|NCT02856802|144681259|NON_INFERIORITY|Assumption that 15% of placebo and 42% of DFN 02 10 mg (treated) subjects would be pain-free at 2 hours. A sample size of 50 subjects in each DB1 dosing arm provided 86% power to detect this assumed difference between placebo and DFN-02 10 mg at a 5% (2-sided) level of significance.|Odds Ratio (OR)|2.68||||0.044|TWO_SIDED|95.0|1.05|6.83|||Fisher Exact|||Statistical testing and confidence intervals (CIs) were 2 sided and performed using a significance (alpha) level of 0.05. All statistical analyses were conducted with the statistical analysis system (SAS)® software package (version 9.3).||6.83|1.05|0.044
72577308|NCT02856802|144681260|NON_INFERIORITY|Non-inferiority conducted as specified in the statistical analysis plan (SAP).||||||0.007||||||The corresponding p-values from Fisher's exact test were computed for the comparison between treatment groups.|Fisher Exact|||||||0.007
72577309|NCT02856802|144681261|NON_INFERIORITY|No assumptions made.|Odds Ratio (OR)|1.31||||0.642|TWO_SIDED|95.0|0.52|3.3|||Fisher Exact|||Statistical testing and confidence intervals (CIs) were 2 sided and performed using a significance (alpha) level of 0.05. All statistical analyses were conducted with the SAS® software package (version 9.3).||3.30|0.52|0.642
72577310|NCT03092219|144681281|SUPERIORITY|||||||0.0001|TWO_SIDED|95.0|||||Fisher Exact|For this outcome measure, missing data were imputed using a LOCF (Last Observation Carried Forward) method.||||||0.0001
72577311|NCT01403051|144681327|SUPERIORITY_OR_OTHER|||||||0.001||||||2-sided test with type I error rate of 5%, not adjusted for multiple comparisons.|Stratified Wilcoxon rank sum test|Stratified Wilcoxon rank sum test for differences between the two treatment groups, stratified by the screening 25-OH vitamin (\<=20 vs. \>20 ng/mL)||The study was sized to have 80% power to detect a 2 % difference in BMD of the hip from baseline to week 48.||||0.001
72628534|NCT01073293|144784991|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority of concomitant versus non-concomitant vaccination is demonstrated if the lower limit of the 95% confidence interval for the fold difference is \>0.5|Fold difference in GMT|0.97|||<|0.001|TWO_SIDED|95.0|0.86|1.11|||ANOVA|||Anti-HPV 45||1.11|0.86|<0.001
72410368|NCT01172938|144329219|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.113||||0.0252|TWO_SIDED|95.0|-0.211|-0.014|||ANCOVA|Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.||Pairwise comparisons (30 mg vs placebo and 20 mg vs placebo) were conducted conditional on the primary endpoint results. If the primary endpoint was statistically significant for both apremilast dose groups, pairwise comparisons for the HAQ-DI were to be evaluated at the 0.05 level using the Hochberg procedure. If only one apremilast dose was statistically significant, then only the comparison between that apremilast dose and placebo was conducted for the HAQ-DI score, at the 0.025 level.||-0.014|-0.211|0.0252
72410369|NCT01172938|144329220|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|22.2|||<|0.0001|TWO_SIDED|95.0|13.4|30.9||Secondary endpoints from the placebo-controlled period (Weeks 16 and 24) were analyzed in a hierarchical fashion to control the Type I error rate as described above.|Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use.|Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the Cochran-Mantel-Haenszel (CMH) weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||30.9|13.4|<0.0001
72577312|NCT03743415|144681364|SUPERIORITY|The key parameter was the coefficient for the trial arm difference in linear mixed effects model that reflected average difference between arms over time (weeks 1-13).|Mean Difference (Final Values)|-0.27|STANDARD_ERROR_OF_MEAN|1.16||0.81|TWO_SIDED|95.0|-2.5|1.96||P-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was .05.|Mixed Models Analysis|Linear mixed effects models were used for 13 repeated measures of the symptom index, adjusting for baseline value.|Mean of SMSH alone minus mean of SMSH+TIPC|The null hypothesis was that the means of two groups were equal. The alternative hypothesis was that the means of two groups were not equal. The adjusted effect size d=0.54 between the SMSH alone group and SMSH+TIPC group was detectable with power of .94 in two-sided tests at .05 level of significance.||1.96|-2.50|.81
72577313|NCT03743415|144681364|SUPERIORITY|The key parameter was the coefficient for the trial arm difference at week 17 in linear mixed effects model.|Mean Difference (Final Values)|-0.58|STANDARD_ERROR_OF_MEAN|2.07||0.78|TWO_SIDED|95.0|-4.65|3.49||P-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was .05.|Mixed Models Analysis|The model included adjustment for baseline value of the symptom index.|Mean of SMSH alone minus SMSH+TIPC.|The null hypothesis was that the means of two groups were equal. The alternative hypothesis was that the means of two groups were not equal. The adjusted effect size d=0.54 between the SMSH alone group and SMSH+TIPC group was detectable with power of .94 in two-sided tests at .05 level of significance.||3.49|-4.65|.78
72577314|NCT03743415|144681364|SUPERIORITY|The key parameter was the coefficient for the trial arm difference in linear mixed effects model that included reflected average difference between arms over time (weeks 1-13).|Mean Difference (Final Values)|0.83|STANDARD_ERROR_OF_MEAN|0.76||0.27|TWO_SIDED|95.0|-0.66|2.32||P-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was .05.|Mixed Models Analysis|Baseline value of the outcome was adjusted for in the model.|Mean of SMSH minus SMSH+TIPC.|The null hypothesis was that the means of two groups were equal. The alternative hypothesis was that the means of two groups were not equal. The adjusted effect size d=0.54 between the SMSH alone group and SMSH+TIPC group was detectable with power of .94 in two-sided tests at .05 level of significance.||2.32|-0.66|.27
72577315|NCT03743415|144681364|SUPERIORITY|The key parameter was the coefficient for the trial arm difference at week 17 in linear mixed effects model.|Mean Difference (Final Values)|1.76|STANDARD_ERROR_OF_MEAN|1.35||0.19|TWO_SIDED|95.0|-0.88|4.39||P-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was .05.|Mixed Models Analysis|Baseline value of the outcome was adjusted for in the model.|Mean of SMSH alone minus SMSH+TIPC.|The null hypothesis was that the means of two groups were equal. The alternative hypothesis was that the means of two groups were not equal. The adjusted effect size d=0.54 between the SMSH alone group and SMSH+TIPC group was detectable with power of .94 in two-sided tests at .05 level of significance.||4.39|-0.88|.19
72577316|NCT03743415|144681365|SUPERIORITY|The key parameter was the coefficient for the trial arm difference in linear mixed effects model that included reflected average difference between arms over weeks 5-13.|Mean Difference (Final Values)|2.43|STANDARD_ERROR_OF_MEAN|2.46||0.53|TWO_SIDED|95.0|-3.3|6.36||P-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was .05.|Mixed Models Analysis|Baseline value of the outcome was adjusted for in the model.|Mean of SMSH alone minus SMSH+TIPC.|The null hypothesis was that the means of two groups were equal. The alternative hypothesis was that the means of two groups were not equal. . The adjusted effect size (Cohen's d=0.54) was used to power comparisons on the primary outcomes reported by groups from the second randomization. This analysis indicated that 60 per group would be required for power of .80 or greater in two-sided tests at α= 0.05.||6.36|-3.30|.53
72577317|NCT03743415|144681365|SUPERIORITY|The key parameter was the coefficient for the trial arm difference at week 17 in linear mixed effects model.|Mean Difference (Final Values)|1.99|STANDARD_ERROR_OF_MEAN|3.92||0.97|TWO_SIDED|95.0|-5.7|9.68||P-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was .05.|Mixed Models Analysis|Baseline value of the outcome was adjusted for in the model.|Mean of SMSH alone minus SMSH+TIPC.|The null hypothesis was that the means of two groups were equal. The alternative hypothesis was that the means of two groups were not equal. . The adjusted effect size (Cohen's d=0.54) was used to power comparisons on the primary outcomes reported by groups from the second randomization. This analysis indicated that 60 per group would be required for power of .80 or greater in two-sided tests at α= 0.05.||9.68|-5.70|.97
72628535|NCT01073293|144784991|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority of concomitant versus non-concomitant vaccination is demonstrated if the lower limit of the 95% confidence interval for the fold difference is \>0.5|Fold difference in GMT|0.95|||<|0.001|TWO_SIDED|95.0|0.85|1.06|||ANOVA|||Anti-HPV 52||1.06|0.85|<0.001
72628536|NCT01073293|144784991|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority of concomitant versus non-concomitant vaccination is demonstrated if the lower limit of the 95% confidence interval for the fold difference is \>0.5|Fold difference in GMT|0.89|||<|0.001|TWO_SIDED|95.0|0.8|0.99|||ANOVA|||Anti-HPV 58||0.99|0.80|<0.001
72410370|NCT01172938|144329220|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|12.4||||0.0038|TWO_SIDED|95.0|4.2|20.7||Secondary endpoints from the placebo-controlled period (Weeks 16 and 24) were analyzed in a hierarchical fashion to control the Type I error rate as described above.|Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use.|Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the Cochran-Mantel-Haenszel (CMH) weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||20.7|4.2|0.0038
72628537|NCT01073293|144784996|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority of concomitant versus non-concomitant vaccination is demonstrated if the lower limit of the 95% confidence interval for the percentage difference is greater than -10|Difference in percentage|0.2|||<|0.001|TWO_SIDED|95.0|-0.7|1.4|||Miettinen and Nurminen|||Anti-diphtheria titer \>=0.1 IU/mL||1.4|-0.7|<0.001
72410371|NCT01172938|144329221|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.182||||0.0005|TWO_SIDED|95.0|-0.283|-0.08||Secondary endpoints from the placebo-controlled period (Weeks 16 and 24) were analyzed in a hierarchical fashion to control the Type I error rate as described above.|ANCOVA|Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.||||-0.080|-0.283|0.0005
72410372|NCT01172938|144329221|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.135||||0.0091|TWO_SIDED|95.0|-0.236|-0.034||Secondary endpoints from the placebo-controlled period (Weeks 16 and 24) were analyzed in a hierarchical fashion to control the Type I error rate as described above.|ANCOVA|Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.||||-0.034|-0.236|0.0091
72410373|NCT01172938|144329222|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|2.42||||0.0056|TWO_SIDED|95.0|0.71|4.13||Secondary endpoints from the placebo-controlled period (Weeks 16 and 24) were analyzed in a hierarchical fashion to control the Type I error rate as described above.|ANCOVA|Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.||||4.13|0.71|0.0056
72410374|NCT01172938|144329222|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|1.7||||0.0504|TWO_SIDED|95.0|0.0|3.4||Secondary endpoints from the placebo-controlled period (Weeks 16 and 24) were analyzed in a hierarchical fashion to control the Type I error rate as described above.|ANCOVA|Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.||||3.40|-0.00|0.0504
72410375|NCT01172938|144329223|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|16.7||||0.0017|TWO_SIDED|95.0|6.6|26.8||Secondary endpoints from the placebo-controlled period (Weeks 16 and 24) were analyzed in a hierarchical fashion to control the Type I error rate as described above.|Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use.|Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the Cochran-Mantel-Haenszel (CMH) weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||26.8|6.6|0.0017
72410376|NCT01172938|144329223|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|8.9|||||TWO_SIDED|95.0|-1.2|18.9|||||Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the Cochran-Mantel-Haenszel (CMH) weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||18.9|-1.2|
72410377|NCT01172938|144329224|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-7.9||||0.0023|TWO_SIDED|95.0|-12.9|-2.8||Secondary endpoints from the placebo-controlled period (Weeks 16 and 24) were analyzed in a hierarchical fashion to control the Type I error rate as described above.|ANCOVA|Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.||||-2.8|-12.9|0.0023
72542701|NCT04128696|144615513|OTHER||Difference in Percentage|-11.8|||||TWO_SIDED|95.0|-22.4|-1.1||||||The comparison between treatment groups was based on the stratified Miettinen \& Nurminen method with strata weighting by sample size and a single treatment covariate. Stratification factors included PD-L1 expression (CPS ≥20 vs. 1≤ CPS \<20) and HPV status (positive vs. negative). Participants with oropharynx HPV negative/unknown and non-oropharyngeal tumors were combined as the HPV negative group.||-1.1|-22.4|
72410378|NCT01172938|144329224|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-5.8|||||TWO_SIDED|95.0|-10.8|-0.7|||||Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.|||-0.7|-10.8|
72410379|NCT01172938|144329225|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.4|||||TWO_SIDED|95.0|-1.2|0.4|||||Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.|||0.4|-1.2|
72410380|NCT01172938|144329225|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.5|||||TWO_SIDED|95.0|-1.3|0.3|||||Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.|||0.3|-1.3|
72410381|NCT01172938|144329226|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.3|||||TWO_SIDED|95.0|-1.1|0.4|||||Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.|||0.4|-1.1|
72410382|NCT01172938|144329226|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.5|||||TWO_SIDED|95.0|-1.3|0.3|||||Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.|||0.3|-1.3|
72628538|NCT01073293|144784996|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority of concomitant versus non-concomitant vaccination is demonstrated if the lower limit of the 95% confidence interval for the percentage difference is greater than -10|Difference in percentage|0.0|||<|0.001|TWO_SIDED|95.0|-1.1|1.2|||Miettinen and Nurminen|||Anti-tetanus titer \>=0.1 IU/mL||1.2|-1.1|<0.001
72628539|NCT01073293|144784997|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority of concomitant versus non-concomitant vaccination is demonstrated if the lower limit of the 95% confidence interval for the fold difference is \>0.67|Fold difference in GMT|0.95|||<|0.001|TWO_SIDED|95.0|0.85|1.06|||ANOVA|||Anti-PT||1.06|0.85|<0.001
72628540|NCT01073293|144784997|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority of concomitant versus non-concomitant vaccination is demonstrated if the lower limit of the 95% confidence interval for the fold difference is \>0.67|Fold difference in GMT|0.99|||<|0.001|TWO_SIDED|95.0|0.9|1.08|||ANOVA|||Anti-FHA||1.08|0.90|<0.001
72410383|NCT01172938|144329227|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-4.88|||||TWO_SIDED|95.0|-7.41|-2.34|||||Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.|||-2.34|-7.41|
72628541|NCT01073293|144784997|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority of concomitant versus non-concomitant vaccination is demonstrated if the lower limit of the 95% confidence interval for the fold difference is \>0.67|Difference in GMT|0.94|||<|0.001|TWO_SIDED|95.0|0.8|1.09|||ANOVA|||Anti-PRN||1.09|0.80|<0.001
72628542|NCT01073293|144784997|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority of concomitant versus non-concomitant vaccination is demonstrated if the lower limit of the 95% confidence interval for the fold difference is \>0.67|Difference in GMT|0.89||||0.005|TWO_SIDED|95.0|0.72|1.11|||ANOVA|||Anti-FIM 2/3||1.11|0.72|0.005
72628543|NCT01073293|144784998|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority of concomitant versus non-concomitant vaccination is demonstrated if the difference is statistically less than 10 percentage points|Difference in percentage|-0.2|||<|0.001|TWO_SIDED|95.0|-1.2|0.8|||Miettinen and Nurminen|||Poliovirus type 1||0.8|-1.2|<0.001
72628544|NCT01073293|144784998|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority of concomitant versus non-concomitant vaccination is demonstrated if the difference is statistically less than 10 percentage points|Difference in percentage|-0.2|||<|0.001|TWO_SIDED|95.0|-1.2|0.8|||Miettinen and Nurminen|||Poliovirus type 2||0.8|-1.2|<0.001
72628545|NCT01073293|144784998|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority of concomitant versus non-concomitant vaccination is demonstrated if the difference is statistically less than 10 percentage points|Difference in percentage|0.0|||<|0.001|TWO_SIDED|95.0|-0.8|0.8|||Miettinen and Nurminen|||Poliovirus type 3||0.8|-0.8|<0.001
72628546|NCT00077974|144785012|SUPERIORITY_OR_OTHER||Percent|33.0||||||95.0|24.2|42.8|||||Using exact method based on binomial distribution. Percent equals n divided by N times 100.|||42.8|24.2|
72410384|NCT01172938|144329227|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-4.39|||||TWO_SIDED|95.0|-6.92|-1.86|||||Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.|||-1.86|-6.92|
72542702|NCT04128696|144615514|OTHER||Difference in Percentage|-18.0|||||TWO_SIDED|95.0|-33.7|-1.4||||||The comparison between treatment groups was based on the stratified Miettinen \& Nurminen method with strata weighting by sample size and a single treatment covariate. Stratification factors included HPV status (positive vs. negative). Participants with oropharynx HPV negative/unknown and non-oropharyngeal tumors were combined as the HPV negative group.||-1.4|-33.7|
72542703|NCT04128696|144615523|SUPERIORITY||Hazard Ratio (HR)|1.17||||0.783|TWO_SIDED|95.0|0.78|1.77||Nominal p-value was calculated based on the one-sided log-rank test, stratified by PD-L1 expression (CPS ≥20 vs. 1≤ CPS \<20) and HPV status (oropharynx HPV positive vs oropharynx HPV negative/unknown and non-oropharynx).|Stratified Cox proportional hazard model|||The hazard ratio and 2-sided 95% CI was calculated from the Cox regression model with Efron's method of tie handling, a treatment covariate and stratified by PD-L1 expression (CPS ≥20 vs. 1≤ CPS \<20) and HPV status (oropharynx HPV positive vs oropharynx HPV negative/unknown and non-oropharynx).||1.77|0.78|0.783
72628547|NCT00256126|144785024|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
72628548|NCT02949011|144785040|SUPERIORITY||Median Difference|-29.1|||<|0.0001|TWO_SIDED|95.0|-42.8|-14.6||Adjusted p-value, two-sided significance level of 0.05|Stratified generalized Wilcoxon test|Peto-Prentice's generalized Wilcoxon test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||The primary analysis of the primary endpoint was a comparison between the baloxavir marboxil and placebo groups.||-14.6|-42.8|<0.0001
72628549|NCT02949011|144785040|SUPERIORITY||Median Difference|-7.7||||0.8347|TWO_SIDED|95.0|-22.7|7.9||Adjusted p-value, two-sided significance level of 0.05|Stratified generalized Wilcoxon test|Peto-Prentice's generalized Wilcoxon test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||The comparison between the baloxavir marboxil and the oseltamivir groups was conducted as a secondary analysis only if a statistically significant difference was observed in the primary analysis in order to maintain control of overall type I error.||7.9|-22.7|0.8347
72628550|NCT02949011|144785040|SUPERIORITY|||||||0.0008||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Log Rank|Log rank test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Analysis using the stratified log rank test was performed as a sensitivity analysis.||||0.0008
72628551|NCT02949011|144785040|SUPERIORITY|||||||0.8449||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Log Rank|Log rank test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Analysis using the stratified log rank test was performed as a sensitivity analysis.||||0.8449
72628552|NCT02949011|144785041|SUPERIORITY||||||<|0.0001||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 2||||<0.0001
72628553|NCT02949011|144785041|SUPERIORITY||||||<|0.0001||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 2||||<0.0001
72628554|NCT02949011|144785041|SUPERIORITY||||||<|0.0001||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 3||||<0.0001
72628555|NCT02949011|144785041|SUPERIORITY||||||<|0.0001||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 3||||<0.0001
72410385|NCT01172938|144329228|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.53|||||TWO_SIDED|95.0|-0.76|-0.31|||||Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.|||-0.31|-0.76|
72628556|NCT02949011|144785041|SUPERIORITY||||||<|0.0001||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 4||||<0.0001
72628557|NCT02949011|144785041|SUPERIORITY|||||||0.0044||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 4||||0.0044
72410386|NCT01172938|144329228|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.47|||||TWO_SIDED|95.0|-0.7|-0.25|||||Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.|||-0.25|-0.70|
72410387|NCT01172938|144329229|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|2.33|||||TWO_SIDED|95.0|0.43|4.23|||||Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.|||4.23|0.43|
72410388|NCT01172938|144329229|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.13|||||TWO_SIDED|95.0|-1.77|2.03|||||Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.|||2.03|-1.77|
72410389|NCT01172938|144329230|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|3.56|||||TWO_SIDED|95.0|1.72|5.4|||||Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.|||5.40|1.72|
72410390|NCT01172938|144329230|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|2.04|||||TWO_SIDED|95.0|0.21|3.88|||||Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.|||3.88|0.21|
72410391|NCT01172938|144329231|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|24.6|||||TWO_SIDED|95.0|15.2|34.0|||||Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the Cochran-Mantel-Haenszel (CMH) weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||34.0|15.2|
72577318|NCT03743415|144681365|SUPERIORITY|The key parameter was the coefficient for the trial arm difference in linear mixed effects model that included reflected average difference between arms over weeks 5-13.|Mean Difference (Final Values)|1.96|STANDARD_ERROR_OF_MEAN|1.94||0.31|TWO_SIDED|95.0|-1.83|5.75||P-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was .05.|Mixed Models Analysis|Baseline value of the outcome was adjusted for in the model.|Mean of SMSH alone minus SMSH+TIPC.|The null hypothesis was that the means of two groups were equal. The alternative hypothesis was that the means of two groups were not equal. . The adjusted effect size (Cohen's d=0.54) was used to power comparisons on the primary outcomes reported by groups from the second randomization. This analysis indicated that 60 per group would be required for power of .80 or greater in two-sided tests at α= 0.05.||5.75|-1.83|.31
72410392|NCT01172938|144329231|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|12.4|||||TWO_SIDED|95.0|3.4|21.5|||||Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the Cochran-Mantel-Haenszel (CMH) weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||21.5|3.4|
72410393|NCT01172938|144329232|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|-10.6|||||TWO_SIDED|95.0|-15.4|-5.7|||||Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.|||-5.7|-15.4|
72410394|NCT01172938|144329232|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-7.1|||||TWO_SIDED|95.0|-12.0|-2.2|||||Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.|||-2.2|-12.0|
72410395|NCT01172938|144329233|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.8|||||TWO_SIDED|95.0|-1.6|0.0|||||Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.|||0.0|-1.6|
72410396|NCT01172938|144329233|SUPERIORITY_OR_OTHER_LEGACY||LS Mean DIfference|-0.8|||||TWO_SIDED|95.0|-1.6|0.1|||||Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.|||0.1|-1.6|
72410397|NCT01172938|144329234|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.5|||||TWO_SIDED|95.0|-1.2|0.3|||||Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.|||0.3|-1.2|
72410398|NCT01172938|144329234|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.7|||||TWO_SIDED|95.0|-1.5|0.1|||||Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.|||0.1|-1.5|
72410399|NCT01172938|144329235|SUPERIORITY_OR_OTHER_LEGACY||LS mean Difference|-6.38|||||TWO_SIDED|95.0|-9.0|-3.75|||||Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.|||-3.75|-9.00|
72410400|NCT01172938|144329235|SUPERIORITY_OR_OTHER_LEGACY||LS mean Difference|-4.41|||||TWO_SIDED|95.0|-7.03|-1.79|||||Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.|||-1.79|-7.03|
72410401|NCT01172938|144329236|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.7|||||TWO_SIDED|95.0|-0.94|-0.46|||||Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.|||-0.46|-0.94|
72410402|NCT01172938|144329236|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.46|||||TWO_SIDED|95.0|-0.7|-0.22|||||Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.|||-0.22|-0.70|
72410403|NCT01172938|144329237|SUPERIORITY_OR_OTHER_LEGACY||LS mean Difference|2.21|||||TWO_SIDED|95.0|0.32|4.1|||||Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.|||4.10|0.32|
72410404|NCT01172938|144329237|SUPERIORITY_OR_OTHER_LEGACY||LS Mean DIfference|0.4|||||TWO_SIDED|95.0|-1.5|2.29|||||Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.|||2.29|-1.50|
72410405|NCT01172938|144329238|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|3.3|||||TWO_SIDED|95.0|-10.1|16.7|||||Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the Cochran-Mantel-Haenszel (CMH) weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||16.7|-10.1|
72628558|NCT02949011|144785041|SUPERIORITY||||||<|0.0001||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 5||||<0.0001
72410406|NCT01172938|144329238|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|7.3|||||TWO_SIDED|95.0|-6.5|21.1|||||Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the Cochran-Mantel-Haenszel (CMH) weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||21.1|-6.5|
72410407|NCT01172938|144329239|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|2.9|||||TWO_SIDED|95.0|-13.4|19.3|||||Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the Cochran-Mantel-Haenszel (CMH) weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||19.3|-13.4|
72410408|NCT01172938|144329239|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|7.7|||||TWO_SIDED|95.0|-9.1|24.6|||||Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the Cochran-Mantel-Haenszel (CMH) weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||24.6|-9.1|
72410409|NCT01172938|144329240|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|19.2|||||TWO_SIDED|95.0|9.0|29.3|||||Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the Cochran-Mantel-Haenszel (CMH) weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||29.3|9.0|
72410410|NCT01172938|144329240|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|16.6|||||TWO_SIDED|95.0|6.4|26.8|||||Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the Cochran-Mantel-Haenszel (CMH) weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||26.8|6.4|
72410411|NCT01172938|144329241|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|13.2|||||TWO_SIDED|95.0|-0.1|26.5|||||Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the Cochran-Mantel-Haenszel (CMH) weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||26.5|-0.1|
72542704|NCT04128696|144615524|SUPERIORITY||Hazard Ratio (HR)|1.0||||0.5|TWO_SIDED|95.0|0.5|2.0||Nominal p-value was calculated based on the log-rank test, stratified by HPV status (oropharynx HPV positive vs oropharynx HPV negative/unknown and non-oropharynx).|Stratified Cox proportional hazard model|||The hazard ratio and 2-sided 95% CI was calculated from the cox regression model with Efron's method of tie handling, a treatment covariate and stratified by HPV status (oropharynx HPV positive vs oropharynx HPV negative/unknown and non-oropharynx).||2.00|0.50|0.500
72410412|NCT01172938|144329241|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|11.3|||||TWO_SIDED|95.0|-2.4|25.0|||||Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the Cochran-Mantel-Haenszel (CMH) weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||25.0|-2.4|
72410413|NCT01172938|144329242|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|8.9|||||TWO_SIDED|95.0|-6.8|24.6|||||Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the Cochran-Mantel-Haenszel (CMH) weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||24.6|-6.8|
72410414|NCT01172938|144329242|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|7.7|||||TWO_SIDED|95.0|-8.7|24.2|||||Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the Cochran-Mantel-Haenszel (CMH) weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||24.2|-8.7|
72410415|NCT01172938|144329243|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|26.3|||||TWO_SIDED|95.0|17.1|35.5|||||Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the Cochran-Mantel-Haenszel (CMH) weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||35.5|17.1|
72628559|NCT02949011|144785041|SUPERIORITY|||||||0.1146||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 5||||0.1146
72410416|NCT01172938|144329243|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|14.2|||||TWO_SIDED|95.0|5.4|23.1|||||Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the Cochran-Mantel-Haenszel (CMH) weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||23.1|5.4|
72410417|NCT01172938|144329244|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|10.3|||||TWO_SIDED|95.0|3.7|16.8|||||Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the Cochran-Mantel-Haenszel (CMH) weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||16.8|3.7|
72410418|NCT01172938|144329244|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|9.5|||||TWO_SIDED|95.0|3.0|16.0|||||Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the Cochran-Mantel-Haenszel (CMH) weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||16.0|3.0|
72410419|NCT01172938|144329245|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|3.1|||||TWO_SIDED|95.0|-0.4|6.5|||||Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the Cochran-Mantel-Haenszel (CMH) weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||6.5|-0.4|
72410420|NCT01172938|144329245|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|4.8|||||TWO_SIDED|95.0|0.8|8.7|||||Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the Cochran-Mantel-Haenszel (CMH) weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||8.7|0.8|
72410421|NCT01172938|144329246|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|14.9|||||TWO_SIDED|95.0|8.3|21.5|||||Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the Cochran-Mantel-Haenszel (CMH) weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||21.5|8.3|
72410422|NCT01172938|144329246|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|10.1|||||TWO_SIDED|95.0|4.0|16.1|||||Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the Cochran-Mantel-Haenszel (CMH) weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||16.1|4.0|
72410423|NCT01172938|144329247|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|9.5|||||TWO_SIDED|95.0|4.8|14.2|||||Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the Cochran-Mantel-Haenszel (CMH) weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||14.2|4.8|
72628560|NCT02949011|144785041|SUPERIORITY|||||||0.0046||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 6||||0.0046
72410424|NCT01172938|144329247|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|4.7|||||TWO_SIDED|95.0|1.2|8.3|||||Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the Cochran-Mantel-Haenszel (CMH) weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||8.3|1.2|
72542705|NCT04128696|144615525|SUPERIORITY||Hazard Ratio (HR)|0.91||||0.329|TWO_SIDED|95.0|0.62|1.34||Nominal p-value was calculated based on the one-sided log-rank test, stratified by PD-L1 expression (CPS ≥20 vs. 1≤ CPS \<20) and HPV status (oropharynx HPV positive vs oropharynx HPV negative/unknown and non-oropharynx).|Stratified Cox proportional hazard model|||The hazard ratio and 2-sided 95% CI was calculated from the Cox regression model with Efron's method of tie handling, a treatment covariate and stratified by PD-L1 expression (CPS ≥20 vs. 1≤ CPS \<20) and HPV status (oropharynx HPV positive vs oropharynx HPV negative/unknown and non-oropharynx).||1.34|0.62|0.329
72628561|NCT02949011|144785041|SUPERIORITY|||||||0.441||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 6||||0.441
72628562|NCT02949011|144785041|SUPERIORITY|||||||0.0929||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 9||||0.0929
72628563|NCT02949011|144785041|SUPERIORITY|||||||0.0907||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 9||||0.0907
72628564|NCT02949011|144785042|SUPERIORITY|||||||0.7383||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 2||||0.7383
72628565|NCT02949011|144785042|SUPERIORITY|||||||0.9619||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 2||||0.9619
72628566|NCT02949011|144785042|SUPERIORITY|||||||0.0576||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 3||||0.0576
72628567|NCT02949011|144785042|SUPERIORITY|||||||0.1237||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 3||||0.1237
72628568|NCT02949011|144785042|SUPERIORITY|||||||0.3071||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 4||||0.3071
72628569|NCT02949011|144785042|SUPERIORITY|||||||0.9603||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 4||||0.9603
72628570|NCT02949011|144785042|SUPERIORITY|||||||0.0784||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 5||||0.0784
72628571|NCT02949011|144785042|SUPERIORITY|||||||0.5547||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 5||||0.5547
72628572|NCT02949011|144785042|SUPERIORITY|||||||0.3087||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 6||||0.3087
72628573|NCT02949011|144785042|SUPERIORITY|||||||0.9106||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 6||||0.9106
72628574|NCT02949011|144785042|SUPERIORITY|||||||0.0017||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 9||||0.0017
72628575|NCT02949011|144785042|SUPERIORITY|||||||0.3068||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 9||||0.3068
72410425|NCT01172938|144329248|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|7.6|||||TWO_SIDED|95.0|-2.8|17.9|||||Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the Cochran-Mantel-Haenszel (CMH) weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||17.9|-2.8|
72410426|NCT01172938|144329248|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|11.9|||||TWO_SIDED|95.0|0.8|23.0|||||Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the Cochran-Mantel-Haenszel (CMH) weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||23.0|0.8|
72410427|NCT01172938|144329249|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|-1.4|||||TWO_SIDED|95.0|-17.7|14.8|||||Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the Cochran-Mantel-Haenszel (CMH) weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||14.8|-17.7|
72410428|NCT01172938|144329249|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|2.4|||||TWO_SIDED|95.0|-14.8|19.6|||||Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the Cochran-Mantel-Haenszel (CMH) weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||19.6|-14.8|
72410429|NCT01172938|144329250|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|17.4|||||TWO_SIDED|95.0|6.6|28.2|||||Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the Cochran-Mantel-Haenszel (CMH) weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||28.2|6.6|
72410430|NCT01172938|144329250|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|16.8|||||TWO_SIDED|95.0|5.6|27.9|||||Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the Cochran-Mantel-Haenszel (CMH) weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||27.9|5.6|
72410431|NCT01172938|144329251|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|5.8|||||TWO_SIDED|95.0|-10.7|22.4|||||Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the Cochran-Mantel-Haenszel (CMH) weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||22.4|-10.7|
72410432|NCT01172938|144329251|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|8.8|||||TWO_SIDED|95.0|-8.5|26.2|||||Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the Cochran-Mantel-Haenszel (CMH) weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||26.2|-8.5|
72410433|NCT04188041|144329274|OTHER|see above||||||0.02|||||||Wilcoxon signed rank test|||Non-parametric Wilcoxon signed rank test for paired data was used to test for significant change in confidence.||||0.02
72410434|NCT02443298|144329293|SUPERIORITY||Hazard Ratio (HR)|1.46||||0.0255|TWO_SIDED|80.0|1.18|1.81|||Cox proportional hazards model||Comparison of Risankizumab to Placebo|This was analyzed by using a Cox proportional hazards model that included treatment and the stratification factor of OCS use at baseline as fixed effects.||1.81|1.18|0.0255
72410435|NCT02443298|144329294|SUPERIORITY||Hazard Ratio (HR)|1.47||||0.0131|TWO_SIDED|80.0|1.2|1.79|||Cox proportional hazards model||Comparison of Risankizumab to Placebo|This was analyzed by using a Cox proportional hazards model that included treatment and the stratification factor of OCS use at baseline as fixed effects.||1.79|1.20|0.0131
72410436|NCT02443298|144329295|SUPERIORITY||Rate Ratio|1.4937|STANDARD_ERROR_OF_MEAN|0.22||0.0065|TWO_SIDED|80.0|1.2366|1.8044|||Negative binomial regression||Comparison of Risankizumab to Placebo|Annualized rate is obtained from fitting a negative binomial regression including logarithm of the exposure as an offset, treatment, and OCS use at baseline as covariate.||1.8044|1.2366|0.0065
72410437|NCT02443298|144329296|SUPERIORITY||Hazard Ratio (HR)|1.18||||0.4619|TWO_SIDED|80.0|0.88|1.57|||Cox proportional hazards model||Comparison of Risankizumab to Placebo|Time to first event is obtained from fitting a Cox proportional-hazards model including treatment, and OCS use at baseline as covariate||1.57|0.88|0.4619
72410438|NCT02443298|144329297|SUPERIORITY||Rate Ratio|1.1317|STANDARD_ERROR_OF_MEAN|0.237||0.555|TWO_SIDED|80.0|0.8652|1.4803|||Negative binomial regression||Comparison of Risankizumab to Placebo|Annualized rate is obtained from fitting a negative binomial regression including logarithm of the exposure as an offset, treatment, and OCS use at baseline as covariate.||1.4803|0.8652|0.5550
72410439|NCT02443298|144329298|SUPERIORITY||Mean Difference (Final Values)|-0.039|STANDARD_ERROR_OF_MEAN|0.051||0.4423|TWO_SIDED|80.0|-0.104|0.026|||Mixed Models Analysis|Unstructured covariance structure for within-patient variation|Comparison of Risankizumab to Placebo|The adjusted mean (SE) are obtained from fitting a mixed effect repeated measures (MMRM) model including treatment, OCS use at baseline, test day, treatment-by-test day interaction, baseline, and baseline-by-test day interaction as covariates patient as a random effect.||0.026|-0.104|0.4423
72410440|NCT02443298|144329299|SUPERIORITY||Mean Difference (Final Values)|-0.068|STANDARD_ERROR_OF_MEAN|0.045||0.1377|TWO_SIDED|80.0|-0.126|-0.009|||Mixed Models Analysis|Unstructured covariance structure for within-patient variation|Comparison of Risankizumab to Placebo|The adjusted mean (SE) are obtained from fitting a mixed effect repeated measures (MMRM) model including treatment, OCS use at baseline, test day, treatment-by-test day interaction, baseline, and baseline-by-test day interaction as covariates patient as a random effect.||-0.009|-0.126|0.1377
72410441|NCT02443298|144329300|SUPERIORITY||Mean Difference (Final Values)|0.149|STANDARD_ERROR_OF_MEAN|0.115||0.1985|TWO_SIDED|80.0|0.0|0.297|||ANCOVA||Comparison of Risankizumab to Placebo|The adjusted mean (SE) are obtained from fitting an analysis of covariance (ANCOVA) model separately for each week including treatment, OCS use at baseline, and baseline as covariates. The weekly averages of daily measurements are calculated before fitting the model.||0.297|0.000|0.1985
72628576|NCT02949011|144785043|SUPERIORITY||||||<|0.0001||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 2||||<0.0001
72628577|NCT02949011|144785043|SUPERIORITY||||||<|0.0001||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 2||||<0.0001
72628578|NCT02949011|144785043|SUPERIORITY||||||<|0.0001||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 3||||<0.0001
72410442|NCT03586999|144329301|SUPERIORITY||proportion|0.3||||0.1|TWO_SIDED|90.0||||The proportion achieving a complete response will be calculated and will compared to null proportion of 30%. The population proportion for complete response rate, p-value and 90% confidence intervals for the complete response rate will be calculated.|t-test, 2 sided|||The study was to be suspended, if, at any time, there was sufficient evidence to suggest that the true probability of achieving a complete response falls below 30% while assuming the treatment drug will elicit a 56% complete response rate. Statistically significant evidence for this low complete response rate is defined as an observed complete response rate whose upper one-sided 90% confidence limit is 0-30%. Sample size calculations were made assuming 80% power.||||.1
72410443|NCT01591746|144329319|SUPERIORITY|||||||0.43|||||||Wilcoxon (Mann-Whitney)|||||||0.43
72410444|NCT01591746|144329320|SUPERIORITY|||||||0.56|||||||Wilcoxon (Mann-Whitney)|||||||0.56
72410445|NCT01591746|144329321|SUPERIORITY|||||||0.45|||||||Wilcoxon (Mann-Whitney)|||Right breast initial percent volume expansion||||0.45
72577319|NCT03743415|144681365|SUPERIORITY|The key parameter was the coefficient for the trial arm difference at week 17 in linear mixed effects model.|Mean Difference (Net)|3.3|STANDARD_ERROR_OF_MEAN|2.77||0.61|TWO_SIDED|95.0|-2.13|8.74||P-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was .05.|Mixed Models Analysis|Baseline value of the outcome was adjusted for in the model.|Mean of SMSH minus SMSH+TIPC|The null hypothesis was that the means of two groups were equal. The alternative hypothesis was that the means of two groups were not equal. The adjusted effect size (Cohen's d=0.54) was used to power comparisons on the primary outcomes reported by groups from the second randomization. This analysis indicated that 60 per group would be required for power of .80 or greater in two-sided tests at α= 0.05.||8.74|-2.13|.61
72577320|NCT03743415|144681366|SUPERIORITY|Key parameter was the difference between arms at week 13.|Mean Difference (Final Values)|-0.99|STANDARD_ERROR_OF_MEAN|1.14||0.44|TWO_SIDED|95.0|-3.12|1.35||P-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was .05.|Regression, Linear|Baseline value of the outcome was adjusted for in the model.|Mean of SMSH minus SMSH+TIPC.|The null hypothesis was that the means of two groups were equal. The alternative hypothesis was that the means of two groups were not equal. Sample size was determined by the power calculation for the primary outcome.||1.35|-3.12|.44
72577321|NCT03743415|144681366|SUPERIORITY|The null hypothesis was that the means of two groups were equal. The alternative hypothesis was that the means of two groups were not equal. Sample size was determined by the power calculation for the primary outcome.|Mean Difference (Final Values)|-0.07|STANDARD_ERROR_OF_MEAN|1.15||0.95|TWO_SIDED|95.0|-2.32|2.18||P-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was .05.|Mixed Models Analysis|Baseline value of the outcome was adjusted for in the model.|Mean of SMSH minus SMSH+TIPC.|The key parameter was the coefficient for the trial arm difference at week 17 in linear mixed effects model.||2.18|-2.32|.95
72577322|NCT03743415|144681366|SUPERIORITY|The key parameter was the coefficient for the trial arm difference at week 13 in linear mixed effects model.|Mean Difference (Final Values)|0.04|STANDARD_ERROR_OF_MEAN|0.96||0.97|TWO_SIDED|95.0|-1.85|1.93||P-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was .05.|Mixed Models Analysis|Baseline value of the outcome was adjusted for in the model.|Mean of SMSH minus SMSH+TIPC.|The null hypothesis was that the means of two groups were equal. The alternative hypothesis was that the means of two groups were not equal. Sample size was determined by the power calculation for the primary outcome.||1.93|-1.85|.97
72577323|NCT03743415|144681366|SUPERIORITY|The key parameter was the coefficient for the trial arm difference at week 17 in linear mixed effects model.|Mean Difference (Final Values)|0.32|STANDARD_ERROR_OF_MEAN|0.96||0.74|TWO_SIDED|95.0|-1.56|2.2||P-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was .05.|Mixed Models Analysis|Baseline value of the outcome was adjusted for in the model.|Mean of SMSH minus SMSH+TIPC.|The null hypothesis was that the means of two groups were equal. The alternative hypothesis was that the means of two groups were not equal. Sample size was determined by the power calculation for the primary outcome.||2.20|-1.56|.74
72577324|NCT03743415|144681367|SUPERIORITY|The key parameter was the coefficient for the trial arm difference at week 13 in linear mixed effects model.|Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|2.31||0.98|TWO_SIDED|95.0|-4.49|4.58||P-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was .05.|Mixed Models Analysis|Baseline value of the outcome was adjusted for in the model.|Mean of SMSH minus mean of SMSH+TIPC.|The null hypothesis was that the means of two groups were equal. The alternative hypothesis was that the means of two groups were not equal. Sample size was determined by the power calculation for the primary outcome.||4.58|-4.49|.98
72577325|NCT03743415|144681367|SUPERIORITY|The key parameter was the coefficient for the trial arm difference at week 17 in linear mixed effects model.|Mean Difference (Final Values)|-0.9|STANDARD_ERROR_OF_MEAN|2.34||0.7|TWO_SIDED|95.0|-5.48|3.68||P-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was .05.|Mixed Models Analysis|Baseline value of the outcome was adjusted for in the model.|Mean of SMSH minus SMSH+TIPC.|The null hypothesis was that the means of two groups were equal. The alternative hypothesis was that the means of two groups were not equal. Sample size was determined by the power calculation for the primary outcome.||3.68|-5.48|.70
72577326|NCT03743415|144681367|SUPERIORITY|The key parameter was the coefficient for the trial arm difference at week 13 in linear mixed effects model.|Mean Difference (Final Values)|-2.0|STANDARD_ERROR_OF_MEAN|1.85||0.27|TWO_SIDED|95.0|-5.62|1.62||P-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was .05.|Mixed Models Analysis|Baseline value of the outcome was adjusted for in the model.|Mean of SMSH minus SMSH+TIPC.|The null hypothesis was that the means of two groups were equal. The alternative hypothesis was that the means of two groups were not equal. Sample size was determined by the power calculation for the primary outcome.||1.62|-5.62|.27
72628579|NCT02949011|144785043|SUPERIORITY|||||||0.0024||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 3||||0.0024
72410446|NCT01591746|144329321|SUPERIORITY|||||||0.98|||||||Wilcoxon (Mann-Whitney)|||Left breast initial percent volume expansion||||0.98
72410447|NCT01591746|144329322|SUPERIORITY|||||||0.43|||||||Wilcoxon (Mann-Whitney)|||||||0.43
72410448|NCT01591746|144329323|SUPERIORITY|||||||0.37|||||||Wilcoxon (Mann-Whitney)|||||||0.37
72410449|NCT01591746|144329324|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||||||1.0
72410450|NCT00833924|144329359|SUPERIORITY_OR_OTHER||Rate of 30-day freedom from MAE|99.2|||<|0.01|TWO_SIDED|95.0|95.4|100.0|||Exact binomial test|||Null hypothesis: The 30-day Freedom from MAE for patients treated with the Zenith® Low Profile AAA Endovascular Graft does not meet the performance goal (88%).||100|95.4|<0.01
72410451|NCT00833924|144329360|SUPERIORITY_OR_OTHER||12-month Device Success Rate|97.3|||<|0.01|TWO_SIDED|95.0|92.4|99.4|||Exact binomial test|||Null hypothesis: The 12-month device success for patients treated with the Zenith® Low Profile AAA Endovascular Graft does not meet the performance goal (84%).||99.4|92.4|<0.01
72410452|NCT01485861|144329364|SUPERIORITY|Unstratified|Hazard Ratio (HR)|0.77||||0.1606|TWO_SIDED|90.0|0.56|1.04|||Log Rank|||||1.04|0.56|0.1606
72410453|NCT01485861|144329364|SUPERIORITY|Unstratified|Hazard Ratio (HR)|0.89||||0.53|TWO_SIDED|90.0|0.66|1.2|||Log Rank|||||1.20|0.66|0.5300
72410454|NCT01485861|144329364|SUPERIORITY|Strata are: prior enzalutamide (Yes vs. No), progression factor (prostate-specific antigen \[PSA\] only vs. other), and number of prior chemotherapy regimens for metastatic disease (one vs. more than one).|Hazard Ratio (HR)|0.75||||0.1689|TWO_SIDED|90.0|0.54|1.05|||Log Rank|||||1.05|0.54|0.1689
72410455|NCT01485861|144329364|SUPERIORITY|Strata are: prior enzalutamide (Yes vs. No), progression factor (PSA only vs. other), and number of prior chemotherapy regimens for metastatic disease (one vs. more than one).|Hazard Ratio (HR)|0.94||||0.7484|TWO_SIDED|90.0|0.69|1.28|||Log Rank|||||1.28|0.69|0.7484
72410456|NCT01485861|144329365|SUPERIORITY|Unstratified|Hazard Ratio (HR)|0.39||||0.0064|TWO_SIDED|90.0|0.22|0.7|||Log Rank|||||0.70|0.22|0.0064
72410457|NCT01485861|144329365|SUPERIORITY|Unstratified|Hazard Ratio (HR)|0.46||||0.0285|TWO_SIDED|90.0|0.25|0.83|||Log Rank|||||0.83|0.25|0.0285
72542706|NCT04128696|144615526|SUPERIORITY||Hazard Ratio (HR)|1.09||||0.608|TWO_SIDED|95.0|0.6|2.0||Nominal p-value was calculated based on the one-sided log-rank test, stratified by HPV status (oropharynx HPV positive vs oropharynx HPV negative/unknown and non-oropharynx).|Stratified Cox proportional hazard model|||The hazard ratio and 2-sided 95% CI was calculated from the Cox regression model with Efron's method of tie handling, a treatment covariate and stratified by HPV status (oropharynx HPV positive vs oropharynx HPV negative/unknown and non-oropharynx).||2.00|0.60|0.608
72542707|NCT00951899|144615530|SUPERIORITY_OR_OTHER|||||||0.0006||95.0||||A P value \< 0.05 was considered statistically significant|t-test, 2 sided|||Comparison of mean total GLP-1 concentration from baseline to 12 weeks in Colesevelam subjects||||0.0006
72542708|NCT00951899|144615530|SUPERIORITY_OR_OTHER|||||||0.3||95.0|||||t-test, 2 sided|||Comparison of mean total GLP-1 concentration from baseline to 12 weeks in Placebo subjects||||0.30
72577327|NCT03743415|144681367|SUPERIORITY|The key parameter was the coefficient for the trial arm difference at week 17 in linear mixed effects model.|Mean Difference (Final Values)|0.21|STANDARD_ERROR_OF_MEAN|1.84||0.91|TWO_SIDED|95.0|-3.4|3.81||P-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was .05.|Mixed Models Analysis|Baseline value of the outcome was adjusted for in the model.|Mean of SMSH minus SMSH+TIPC.|The null hypothesis was that the means of two groups were equal. The alternative hypothesis was that the means of two groups were not equal. Sample size was determined by the power calculation for the primary outcome.||3.81|-3.40|.91
72577328|NCT03743415|144681368|SUPERIORITY|The key parameter was the coefficient for the trial arm difference at week 13 in linear mixed effects model.|Mean Difference (Final Values)|-1.93|STANDARD_ERROR_OF_MEAN|1.06||0.06|TWO_SIDED|95.0|-3.98|0.19||P-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was .05.|Mixed Models Analysis|Baseline value of the outcome was adjusted for in the model.|Mean of SMSH minus SMSH+TIPC.|The null hypothesis was that the means of two groups were equal. The alternative hypothesis was that the means of two groups were not equal. Sample size was determined by the power calculation for the primary outcome.||0.19|-3.98|.06
72628580|NCT02949011|144785043|SUPERIORITY|||||||0.9127||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ven Elteren test|Van Elteren test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 4||||0.9127
72410458|NCT01485861|144329383|SUPERIORITY|Unstratified|Hazard Ratio (HR)|0.87||||0.417|TWO_SIDED|95.0|0.62|1.22|||Log Rank|||||1.22|0.62|0.4170
72410459|NCT01485861|144329383|SUPERIORITY|Unstratified|Hazard Ratio (HR)|0.93||||0.6712|TWO_SIDED|95.0|0.67|1.3|||Log Rank|||||1.30|0.67|0.6712
72410460|NCT01485861|144329383|SUPERIORITY||Hazard Ratio (HR)|0.89||||0.5164|TWO_SIDED|95.0|0.62|1.27|||Log Rank|||Strata were: prior enzalutamide (Yes vs. No), progression factor (PSA only vs. other), and number of prior chemotherapy regimens for metastatic disease (one vs. more than one).||1.27|0.62|0.5164
72410461|NCT01485861|144329383|SUPERIORITY||Hazard Ratio (HR)|1.02||||0.8955|TWO_SIDED|95.0|0.72|1.44|||Log Rank|||Strata were: prior enzalutamide (Yes vs. No), progression factor (PSA only vs. other), and number of prior chemotherapy regimens for metastatic disease (one vs. more than one).||1.44|0.72|0.8955
72410462|NCT01485861|144329384|SUPERIORITY|Unstratified|Hazard Ratio (HR)|0.63||||0.1472|TWO_SIDED|95.0|0.33|1.19|||Log Rank|||||1.19|0.33|0.1472
72410463|NCT01485861|144329384|SUPERIORITY|Unstratified|Hazard Ratio (HR)|0.45||||0.0157|TWO_SIDED|95.0|0.23|0.87|||Log Rank|||||0.87|0.23|0.0157
72410464|NCT01485861|144329387|SUPERIORITY||Hazard Ratio (HR)|0.7|||=|0.0665|TWO_SIDED|90.0|0.51|0.97|||Log Rank|||||0.97|0.51|= 0.0665
72410465|NCT01485861|144329387|SUPERIORITY||Hazard Ratio (HR)|0.99|||=|0.9319|TWO_SIDED|90.0|0.73|1.33|||Log Rank|||||1.33|0.73|= 0.9319
72410466|NCT01485861|144329387|SUPERIORITY||Hazard Ratio (HR)|0.7|||=|0.071|TWO_SIDED|90.0|0.5|0.97|||Log Rank|||Strata were: prior Enzalutamide (Yes vs. No), progression factor (PSA only vs. other), and number of prior chemotherapy regimens for metastatic disease (one vs. more than one).||0.97|0.50|= 0.0710
72410467|NCT01485861|144329387|SUPERIORITY||Hazard Ratio (HR)|0.95|||=|0.789|TWO_SIDED|90.0|0.7|1.31|||Log Rank|||Strata were: prior enzalutamide (Yes vs. No), progression factor (PSA only vs. other), and number of prior chemotherapy regimens for metastatic disease (one vs. more than one).||1.31|0.70|= 0.7890
72410468|NCT01485861|144329388|SUPERIORITY||Hazard Ratio (HR)|0.68|||=|0.2906|TWO_SIDED|90.0|0.37|1.25|||Log Rank|||||1.25|0.37|= 0.2906
72410469|NCT01485861|144329388|SUPERIORITY||Hazard Ratio (HR)|0.65|||=|0.2716|TWO_SIDED|90.0|0.35|1.22|||Log Rank|||||1.22|0.35|= 0.2716
72410470|NCT01485861|144329389|SUPERIORITY|Unstratified|Difference in response rates|1.97|||=|0.7913|TWO_SIDED|90.0|-10.25|14.18|||Chi-squared|||||14.18|-10.25|= 0.7913
72410471|NCT01485861|144329389|SUPERIORITY|Unstratified|Difference in response rates|-1.22|||=|0.8675|TWO_SIDED|90.0|-13.24|10.8|||Chi-squared|||||10.80|-13.24|= 0.8675
72410472|NCT01485861|144329390|SUPERIORITY||Difference in response rates|11.43|||=|0.4176|TWO_SIDED|90.0|-11.43|58.32|||Chi-squared|||||58.32|-11.43|= 0.4176
72410473|NCT01485861|144329390|SUPERIORITY||Difference in response rates|15.43|||=|0.2802|TWO_SIDED|90.0|-7.58|38.44|||Chi-squared|||||38.44|-7.58|= 0.2802
72410474|NCT01485861|144329391|SUPERIORITY||Difference in response rates|9.58|||=|0.3646|TWO_SIDED|90.0|-7.65|26.8|||Chi-squared|||||26.80|-7.65|= 0.3646
72410475|NCT01485861|144329391|SUPERIORITY||Difference in response rates|0.22|||=|0.9821|TWO_SIDED|90.0|-15.89|16.33|||Chi-squared|||||16.33|-15.89|= 0.9821
72410476|NCT01485861|144329392|SUPERIORITY||Difference in response rates|-3.17|||=|0.8489|TWO_SIDED|90.0|-30.93|24.58|||Chi-squared|||||24.58|-30.93|= 0.8489
72577329|NCT03743415|144681368|SUPERIORITY|The key parameter was the coefficient for the trial arm difference at week 17 in linear mixed effects model.|Mean Difference (Final Values)|-1.78|STANDARD_ERROR_OF_MEAN|1.0||0.09|TWO_SIDED|95.0|-3.81|0.11||P-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was .05.|Mixed Models Analysis|Baseline value of the outcome was adjusted for in the model.|Mean of SMSH minus SMSH+TIPC|The null hypothesis was that the means of two groups were equal. The alternative hypothesis was that the means of two groups were not equal. Sample size was determined by the power calculation for the primary outcome.||0.11|-3.81|.09
72410477|NCT01485861|144329392|SUPERIORITY||Difference in response rates|12.38|||=|0.5186|TWO_SIDED|90.0|-16.36|41.12|||Chi-squared|||||41.12|-16.36|= 0.5186
72410478|NCT01485861|144329393|SUPERIORITY|Unstratified|Hazard Ratio (HR)|1.31|||=|0.678|TWO_SIDED|90.0|0.45|3.8|||Log Rank|||||3.80|0.45|= 0.6780
72410479|NCT01485861|144329393|SUPERIORITY|Unstratified|Hazard Ratio (HR)|0.85|||=|0.8372|TWO_SIDED|90.0|0.24|3.02|||Log Rank|||||3.02|0.24|= 0.8372
72410480|NCT01485861|144329393|SUPERIORITY||Hazard Ratio (HR)|0.77|||=|0.7733|TWO_SIDED|90.0|0.17|3.5|||Log Rank|||Strata were: prior enzalutamide (Yes vs. No), progression factor (PSA only vs. other), and number of prior chemotherapy regimens for metastatic disease (one vs. more than one).||3.50|0.17|= 0.7733
72410481|NCT01485861|144329393|SUPERIORITY||Hazard Ratio (HR)|2.46|||=|0.4227|TWO_SIDED|90.0|0.36|16.59|||Log Rank|||Strata were: prior enzalutamide (Yes vs. No), progression factor (PSA only vs. other), and number of prior chemotherapy regimens for metastatic disease (one vs. more than one).||16.59|0.36|= 0.4227
72410482|NCT01485861|144329394|SUPERIORITY||Hazard Ratio (HR)|999.99|||=|0.3173|TWO_SIDED|90.0|0.0||NA = Not estimable due to limited number of events observed||Log Rank||\>||||0.00|= 0.3173
72410483|NCT01485861|144329394|SUPERIORITY||Hazard Ratio (HR)|999.99|||=|0.6171|TWO_SIDED|90.0|0.0||NA = Not estimable due to limited number of events observed||Log Rank||\>||||0.00|= 0.6171
72410484|NCT01485861|144329395|SUPERIORITY||Difference in response rates|3.75|||=|0.6652|TWO_SIDED|90.0|-10.47|17.97|||Chi-squared|||||17.97|-10.47|= 0.6652
72410485|NCT01485861|144329395|SUPERIORITY||Difference in response rates|7.48|||=|0.3734|TWO_SIDED|90.0|-6.29|21.24|||Chi-squared|||||21.24|-6.29|= 0.3734
72410486|NCT01485861|144329396|SUPERIORITY||Difference in response rates|4.41|||=|0.7633|TWO_SIDED|90.0|-19.76|28.58|||Chi-squared|||||28.58|-19.76|= 0.7633
72410487|NCT01485861|144329396|SUPERIORITY||Difference in response rates|4.41|||=|0.7633|TWO_SIDED|90.0|-19.76|28.58|||Chi-squared|||||28.58|-19.76|= 0.7633
72410488|NCT01485861|144329397|SUPERIORITY||Difference in response rates|2.24|||=|0.8317|TWO_SIDED|90.0|-15.07|19.54|||Chi-squared|||||19.54|-15.07|= 0.8317
72410489|NCT01485861|144329397|SUPERIORITY||Difference in response rates|5.14|||=|0.6139|TWO_SIDED|90.0|-11.6|21.88|||Chi-squared|||||21.88|-11.60|= 0.6139
72410490|NCT01485861|144329398|SUPERIORITY||Difference in response rates|34.85|||=|0.0505|TWO_SIDED|90.0|7.14|62.56|||Chi-squared|||||62.56|7.14|= 0.0505
72410491|NCT01485861|144329398|SUPERIORITY||Difference in response rates|-9.6|||=|0.4989|TWO_SIDED|90.0|-32.54|13.35|||Chi-squared|||||13.35|-32.54|= 0.4989
72410492|NCT01485861|144329401|SUPERIORITY|Unstratified|Hazard Ratio (HR)|0.95|||=|0.8483|TWO_SIDED|90.0|0.61|1.47|||Log Rank|||||1.47|0.61|= 0.8483
72410493|NCT01485861|144329401|SUPERIORITY|Unstratified|Hazard Ratio (HR)|1.08|||=|0.785|TWO_SIDED|90.0|0.7|1.65|||Log Rank|||||1.65|0.70|= 0.7850
72410494|NCT01485861|144329401|SUPERIORITY||Hazard Ratio (HR)|1.04|||=|0.8847|TWO_SIDED|90.0|0.66|1.65|||Log Rank|||Strata were: prior enzalutamide (Yes vs. No), progression factor (PSA only vs. other), and number of prior chemotherapy regimens for metastatic disease (one vs. more than one).||1.65|0.66|= 0.8847
72410495|NCT01485861|144329401|SUPERIORITY||Hazard Ratio (HR)|1.05|||=|0.8647|TWO_SIDED|90.0|0.67|1.63|||Log Rank|||Strata were: prior enzalutamide (Yes vs. No), progression factor (PSA only vs. other), and number of prior chemotherapy regimens for metastatic disease (one vs. more than one).||1.63|0.67|= 0.8647
72410496|NCT01485861|144329402|SUPERIORITY||Hazard Ratio (HR)|0.89|||=|0.8271|TWO_SIDED|90.0|0.39|2.06|||Log Rank|||||2.06|0.39|= 0.8271
72410497|NCT01485861|144329402|SUPERIORITY||Hazard Ratio (HR)|0.84|||=|0.7383|TWO_SIDED|90.0|0.35|2.02|||Log Rank|||||2.02|0.35|= 0.7383
72410498|NCT01410110|144329406|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.66|STANDARD_ERROR_OF_MEAN|4.41||0.55|TWO_SIDED|95.0|-11.57|6.25||a prior threshold p \< .05|t-test, 2 sided|df = 40||t-test for equality of means||6.25|-11.57|.55
72410499|NCT01410110|144329407|SUPERIORITY_OR_OTHER||Slope|0.162|STANDARD_ERROR_OF_MEAN|0.94||0.86|TWO_SIDED|95.0|-1.73|2.05||Time X Condition|Mixed Models Analysis|Mixed Models allows for all randomized participants (N=48) to be included in the model.||F Test (df = 1,39.32), Type III Fixed Effects for Time X Condition||2.05|-1.73|.86
72410500|NCT01410110|144329408|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.49|STANDARD_ERROR_OF_MEAN|2.41|<|0.31|TWO_SIDED|95.0|-7.36|2.39||a priori threshold p \< .05|t-test, 2 sided|||||2.39|-7.36|<.31
72410501|NCT01410110|144329409|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.152|STANDARD_ERROR_OF_MEAN|0.952||0.87|TWO_SIDED|95.0|-1.77|2.08||a priori threshold p \< .05|t-test, 2 sided|df=39||||2.08|-1.77|.87
72410502|NCT01410110|144329410|SUPERIORITY_OR_OTHER||Slope|-0.37|STANDARD_ERROR_OF_MEAN|0.84||0.67|TWO_SIDED|95.0|-2.07|1.33|||Mixed Models Analysis|Time X Condition||Type III Fixed Effects for Time X Condition F Test (df = 1,36.86)||1.33|-2.07|.67
72410503|NCT01410110|144329411|SUPERIORITY_OR_OTHER||Slope|-0.42|STANDARD_ERROR_OF_MEAN|0.62||0.5|TWO_SIDED|95.0|-1.67|0.83|||Mixed Models Analysis|Time X Condition||Type III Fixed Effects for Time X Condition, F Test F (df = 1,42.4)||.83|-1.67|.50
72329436|NCT03037476|144184380|OTHER|General Linear Model|Slope|-0.235||||0.03|TWO_SIDED|95.0|-0.446|-0.023|||Mixed Models Analysis|Negative Binomial Regression||Changes from Baseline to 6 Month Follow-up Outcomes reported in this section.||-.023|-.446|0.03
72410504|NCT01410110|144329412|SUPERIORITY_OR_OTHER||Slope|1.16|STANDARD_ERROR_OF_MEAN|0.42||0.008|TWO_SIDED|95.0|0.32|2.01|||Mixed Models Analysis|Time X Condition||Type III Fixed Effects Time X Condition F Test (df = 1,70.15)||2.01|.32|.008
72410505|NCT01410110|144329413|SUPERIORITY_OR_OTHER||Slope|2.025|STANDARD_ERROR_OF_MEAN|0.93||0.03|TWO_SIDED|95.0|0.169|3.93|||Mixed Models Analysis|Time X Condition||Type III Fixed Effects Time X Condition F Test (df = 1,37.8)||3.93|.169|.03
72542709|NCT02046369|144615548|SUPERIORITY|The primary efficacy endpoint (the change from baseline in CDRS-R total score at Week 6)will be analyzed using a likelihood-based mixed model for repeated measures (MMRM).The response (dependent) variable is the change from baseline in CDRS-R total score assessed weekly (Weeks 1 to 6).The MMRM model includes fixed effects terms for treatment, visit (as a categorical variable), pooled country, age stratum (stratification factor, CDRS-R total score at baseline, and treatment-by-visit interaction.|LS mean differnce (SE)|-5.7|STANDARD_ERROR_OF_MEAN|1.39|<|0.0001|TWO_SIDED|95.0|-8.4|-3.0|||LS mean differnece (SE)|||A mean difference in change from Baseline in CDRS-R total score of 5.0 units was assumed for the lurasidone 20-80 mg/day arm over the placebo arm, and a common standard deviation of 14.2 units (effect size=0.35), a sample size of 145 subjects per treatment arm was calculated to yield a power of 85%. With an expected attrition rate of 15%, approximately 170 subjects per treatment arm (340 in total) were to be randomized in a 1:1 ratio .||-3.0|-8.4|<0.0001
72542710|NCT02046369|144615549|SUPERIORITY||LS mean differnce (SE)|-1.1|STANDARD_ERROR_OF_MEAN|0.54||0.0385|TWO_SIDED|95.0|-2.2|-0.1|||LS mean differnece (SE)|||LS mean difference, and the associated 95% CI and p-value for change from baseline are based on Mixed Model for Repeated Measures (MMRM).||-0.1|-2.2|0.0385
72542711|NCT02046369|144615550|SUPERIORITY||LS mean differnce (SE)|3.9|STANDARD_ERROR_OF_MEAN|1.35||0.0044|TWO_SIDED|95.0|1.2|6.5|||LS mean differnece (SE)|||LS mean difference, and the associated 95% CI and p-value for change from baseline are based on Mixed Model for Repeated Measures (MMRM).||6.5|1.2|0.0044
72542712|NCT02046369|144615551|SUPERIORITY||LS mean differnce (SE)|4.7|STANDARD_ERROR_OF_MEAN|1.19|<|0.0001|TWO_SIDED|95.0|2.4|7.0|||LS mean differnece (SE)|||LS mean difference, and the associated 95% CI and p-value for change from baseline are based on Mixed Model for Repeated Measures (MMRM).||7.0|2.4|<0.0001
72542713|NCT02046369|144615552|SUPERIORITY||LS mean differnce (SE)|-0.7|STANDARD_ERROR_OF_MEAN|0.77||0.3715|TWO_SIDED|95.0|-2.2|0.8|||ANCOVA|||LS mean difference, and the associated 95% CI and p-value for change from baseline are based on Mixed Model for Repeated Measures (MMRM).||0.8|-2.2|0.3715
72542714|NCT02046369|144615553|SUPERIORITY||LS mean differnce (SE)|-0.44|STANDARD_ERROR_OF_MEAN|0.112|<|0.0001|TWO_SIDED|95.0|-0.66|-0.22||LS mean difference, and the associated 95% CI and p-value for change from baseline are based on Mixed Model for Repeated Measures (MMRM).|LS mean differnece (SE)|||||-0.22|-0.66|<0.0001
72542715|NCT02557672|144615584|SUPERIORITY||Ratio of the Geometric Means|0.98||||0.84|TWO_SIDED|95.0|0.81|1.19|||Regression, Linear|||||1.19|0.81|0.84
72542716|NCT02557672|144615585|SUPERIORITY||Odds Ratio (OR)|0.49||||0.09|TWO_SIDED|95.0|0.22|1.11|||Regression, Logistic|||||1.11|0.22|0.09
72542717|NCT02557672|144615586|SUPERIORITY||Odds Ratio, log|0.76||||0.51|TWO_SIDED|95.0|0.33|1.73|||Regression, Logistic|||||1.73|0.33|0.51
72628581|NCT02949011|144785043|SUPERIORITY|||||||0.5361||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 4||||0.5361
72542718|NCT02557672|144615587|SUPERIORITY||Odds Ratio (OR)|1.39||||0.53|TWO_SIDED|95.0|0.51|3.79|||Regression, Logistic|||||3.79|0.51|0.53
72542719|NCT02557672|144615588|SUPERIORITY||Odds Ratio (OR)|0.52||||0.39|TWO_SIDED|95.0|0.12|2.3|||Regression, Logistic|||||2.30|0.12|0.39
72542720|NCT00420290|144615589|SUPERIORITY_OR_OTHER|||||||0.008||95.0||||0.031 is the upper level of significance|ANCOVA|||Using data from 128 CHD patients, CRP data were highly skewed, and data were log transformed to achieve normality. With 14 pts in each group (total of 28), it was predicted the minimum detectable difference between control and intervention would be 15% (1.22 for control group and 1.00 for the intervention group), with an 80% power and an alpha of 0.05 using t test approach. Thus, planned sample size was 30 to complete the study.||||0.008
72542721|NCT00420290|144615590|SUPERIORITY_OR_OTHER|||||||0.03|||||||ANCOVA|||||||0.03
72542722|NCT00420290|144615591|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||ANCOVA|||||||>0.05
72542723|NCT00420290|144615592|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||ANCOVA|||||||>0.05
72542724|NCT00420290|144615593|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||ANCOVA|||||||>0.05
72542725|NCT02092961|144615594|SUPERIORITY_OR_OTHER||Treatment difference|-1.75||||0.022|TWO_SIDED|90.0|-2.75|-0.42||A negative value for change from baseline in OMERACT RAMRIS synovitis score indicates a better clinical condition.|Van Elteren|Estimated using the Van Elteren test stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant).|The point estimate for the median difference in change from baseline and associated 90% CI was calculated using the method of unstratified Hodges-Lehmann. A treatment difference \<0 indicates a benefit towards fostamatinib.|6 weeks||-0.42|-2.75|0.022
72542726|NCT02092961|144615594|SUPERIORITY_OR_OTHER||Treatment difference|0.5||||0.402|TWO_SIDED|90.0|-1.0|2.0||A negative value for change from baseline in OMERACT RAMRIS synovitis score indicates a better clinical condition.|Van Elteren|Estimated using the Van Elteren test stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant).|The point estimate for the median difference in change from baseline and associated 90% CI was calculated using the method of unstratified Hodges-Lehmann. A treatment difference \<0 indicates a benefit towards fostamatinib.|24 weeks||2.00|-1.00|0.402
72410506|NCT01410110|144329414|SUPERIORITY_OR_OTHER||Slope|3.86|STANDARD_ERROR_OF_MEAN|2.77||0.17|TWO_SIDED|95.0|-1.73|9.46||a priori p-value is .05. for two-tailed test. Positive estimated value is in the direction of the experimental condition.|Mixed Models Analysis|Time X Condition||Type III Fixed Effects for Time X Condition F Test (df = 1,39.8)||9.46|-1.73|.17
72410507|NCT02708745|144329419|SUPERIORITY|||||||0.29|||||||t-test, 2 sided|||||||.29
72410508|NCT02708745|144329420|SUPERIORITY|||||||0.18|||||||Chi-squared|||||||0.18
72410509|NCT02708745|144329421|SUPERIORITY|||||||0.78||||||For the barrier 'not having enough time to discuss vaccine concerns', P=0.78. For the barrier 'not realizing until late in visit that parent had vaccine concerns', P=0.37. For the barrier 'not understanding parent specific vaccine concerns', P=0.66.|Chi-squared|||||||0.78
72410510|NCT02480621|144329431|SUPERIORITY||Mean Difference (Net)|1.74|||<|0.1|TWO_SIDED||||||t-test, 2 sided|||||||<0.10
72410511|NCT01385059|144329432|OTHER||||||>|0.05|||||||t-test, 2 sided|||||||>0.05
72577330|NCT03743415|144681368|SUPERIORITY|The key parameter was the coefficient for the trial arm difference at week 13 in linear mixed effects model.|Mean Difference (Final Values)|0.14|STANDARD_ERROR_OF_MEAN|0.97||0.89|TWO_SIDED|95.0|-1.77|2.04||P-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was .05.|Mixed Models Analysis|Baseline value of the outcome was adjusted for in the model.|Mean of SMSH minus SMSH+TIPC|The null hypothesis was that the means of two groups were equal. The alternative hypothesis was that the means of two groups were not equal. Sample size was determined by the power calculation for the primary outcome.||2.04|-1.77|.89
72577331|NCT03743415|144681368|SUPERIORITY|The key parameter was the coefficient for the trial arm difference at week 17 in linear mixed effects model.|Mean Difference (Final Values)|0.96|STANDARD_ERROR_OF_MEAN|0.96||0.47|TWO_SIDED|95.0|-1.2|2.58||P-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was .05.|Mixed Models Analysis|Baseline value of the outcome was adjusted for in the model.|Mean of SMSH minus SMSH+TIPC.|The null hypothesis was that the means of two groups were equal. The alternative hypothesis was that the means of two groups were not equal. Sample size was determined by the power calculation for the primary outcome.||2.58|-1.20|.47
72577332|NCT03743415|144681369|SUPERIORITY|The key parameter was the coefficient for the trial arm difference at week 13 in linear mixed effects model.|Mean Difference (Final Values)|-1.41|STANDARD_ERROR_OF_MEAN|1.94||0.45|TWO_SIDED|95.0|-5.22|2.39||P-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was .05.|Mixed Models Analysis|Baseline value of the outcome was adjusted for in the model.|Mean of SMSH minus SMSH+TIPC.|The null hypothesis was that the means of two groups were equal. The alternative hypothesis was that the means of two groups were not equal. Sample size was determined by the power calculation for the primary outcome.||2.39|-5.22|.45
72577333|NCT03743415|144681369|SUPERIORITY|The key parameter was the coefficient for the trial arm difference at week 17 in linear mixed effects model.|Mean Difference (Final Values)|0.26|STANDARD_ERROR_OF_MEAN|1.97||0.82|TWO_SIDED|95.0|-3.59|4.12||P-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was .05.|Mixed Models Analysis|Baseline value of the outcome was adjusted for in the model.|Mean of SMSH minus SMSH+TIPC.|The null hypothesis was that the means of two groups were equal. The alternative hypothesis was that the means of two groups were not equal. Sample size was determined by the power calculation for the primary outcome.||4.12|-3.59|.82
72577334|NCT03743415|144681369|SUPERIORITY|The key parameter was the coefficient for the trial arm difference at week 13 in linear mixed effects model.|Mean Difference (Final Values)|0.55|STANDARD_ERROR_OF_MEAN|1.88||0.77|TWO_SIDED|95.0|-3.13|4.23||P-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was .05.|Mixed Models Analysis|Baseline value of the outcome was adjusted for in the model.|Mean of SMSH minus SMSH+TIPC.|The null hypothesis was that the means of two groups were equal. The alternative hypothesis was that the means of two groups were not equal. Sample size was determined by the power calculation for the primary outcome.||4.23|-3.13|.77
72628582|NCT02949011|144785043|SUPERIORITY|||||||0.5739||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 5||||0.5739
72410512|NCT03056690|144329436|SUPERIORITY|Mixed model repeated measures (MMRM) analysis model is performed with change from baseline (Week 8) as response; treatment, center (pooled where necessary), time (week 8) and treatment\*time as fixed effects, baseline and baseline\*time as covariates.|LSMean Difference|-0.34|STANDARD_ERROR_OF_MEAN|0.25||0.086|TWO_SIDED|90.0|-0.76|0.07|||MMRM|||||0.07|-0.76|0.086
72410513|NCT03056690|144329442|SUPERIORITY||Difference|0.2||||0.551|TWO_SIDED|90.0|-11.9|12.5|||Fisher Exact|CI for each treatment group and the difference of the proportions is an exact unconditional confidence interval based on Santner-Snell approach.||||12.5|-11.9|0.551
72410514|NCT03056690|144329443|SUPERIORITY||Difference|6.9||||0.202|TWO_SIDED|90.0|-5.2|19.1|||Fisher Exact|CI for each treatment group and the difference of the proportions is an exact unconditional confidence interval based on Santner-Snell approach.||||19.1|-5.2|0.202
72410515|NCT03056690|144329444|SUPERIORITY||Difference|1.7||||0.451|TWO_SIDED|90.0|-10.5|13.8|||Fisher Exact|CI for each treatment group and the difference of the proportions is an exact unconditional confidence interval based on Santner-Snell approach.||||13.8|-10.5|0.451
72410516|NCT03056690|144329445|SUPERIORITY||Difference|6.1||||0.174|TWO_SIDED|90.0|-6.2|18.1|||Fisher Exact|CI for each treatment group and the difference of the proportions is an exact unconditional confidence interval based on Santner-Snell approach.||||18.1|-6.2|0.174
72410517|NCT03056690|144329446|SUPERIORITY||Least Square (LS) Mean difference|-1.48|STANDARD_ERROR_OF_MEAN|2.04||0.235|TWO_SIDED|90.0|-4.86|1.9||MMRM analysis model is performed with change from baseline (Weeks 2, 4, and 8) as response; treatment, center (pooled where necessary), time (Weeks 2, 4 and 8), treatment\*time as fixed effects, baseline and baseline\*time as covariates.|MMRM|||Function Subscale: Week 2||1.90|-4.86|0.235
72410518|NCT03056690|144329446|SUPERIORITY||LSMean Difference|-2.97|STANDARD_ERROR_OF_MEAN|2.34||0.103|TWO_SIDED|90.0|-6.84|0.89||MMRM analysis model is performed with change from baseline (Weeks 2, 4, and 8) as response; treatment, center (pooled where necessary), time (Weeks 2, 4 and 8), treatment\*time as fixed effects, baseline and baseline\*time as covariates.|MMRM|||Function Subscale: Week 4||0.89|-6.84|0.103
72410519|NCT03056690|144329446|SUPERIORITY||LSMean Difference|-2.59|STANDARD_ERROR_OF_MEAN|2.53||0.154|TWO_SIDED|90.0|-6.78|1.6||MMRM analysis model is performed with change from baseline (Weeks 2, 4, and 8) as response; treatment, center (pooled where necessary), time (Weeks 2, 4 and 8), treatment\*time as fixed effects, baseline and baseline\*time as covariates.|MMRM|||Function Subscale: Week 8||1.60|-6.78|0.154
72410520|NCT03056690|144329446|SUPERIORITY||LSMean Difference|-1.34|STANDARD_ERROR_OF_MEAN|1.88||0.238|TWO_SIDED|90.0|-4.45|1.77||MMRM analysis model is performed with change from baseline (Weeks 2, 4, and 8) as response; treatment, center (pooled where necessary), time (Weeks 2, 4 and 8), treatment\*time as fixed effects, baseline and baseline\*time as covariates.|MMRM|||Symptoms Subscale: Week 2||1.77|-4.45|0.238
72410521|NCT03056690|144329446|SUPERIORITY||LSMean Difference|-3.73|STANDARD_ERROR_OF_MEAN|2.11||0.039|TWO_SIDED|90.0|-7.22|-0.24||MMRM analysis model is performed with change from baseline (Weeks 2, 4, and 8) as response; treatment, center (pooled where necessary), time (Weeks 2, 4 and 8), treatment\*time as fixed effects, baseline and baseline\*time as covariates.|MMRM|||Symptoms Subscale: Week 4||-0.24|-7.22|0.039
72410522|NCT03056690|144329446|SUPERIORITY||LSMean Difference|-3.06|STANDARD_ERROR_OF_MEAN|2.34||0.097|TWO_SIDED|90.0|-6.93|0.81||MMRM analysis model is performed with change from baseline (Weeks 2, 4, and 8) as response; treatment, center (pooled where necessary), time (Weeks 2, 4 and 8), treatment\*time as fixed effects, baseline and baseline\*time as covariates.|MMRM|||Symptoms Subscale: Week 8||0.81|-6.93|0.097
72410523|NCT03056690|144329446|SUPERIORITY||LSMean DIfference|-0.99|STANDARD_ERROR_OF_MEAN|0.63||0.057|TWO_SIDED|90.0|-2.03|0.04||MMRM analysis model is performed with change from baseline (Weeks 2, 4, and 8) as response; treatment, center (pooled where necessary), time (Weeks 2, 4 and 8), treatment\*time as fixed effects, baseline and baseline\*time as covariates.|MMRM|||Overall Impact Subscale: Week 2||0.04|-2.03|0.057
72410524|NCT03056690|144329446|SUPERIORITY||LSMean Difference|-1.34|STANDARD_ERROR_OF_MEAN|0.63||0.018|TWO_SIDED|90.0|-2.39|-0.29||MMRM analysis model is performed with change from baseline (Weeks 2, 4, and 8) as response; treatment, center (pooled where necessary), time (Weeks 2, 4 and 8), treatment\*time as fixed effects, baseline and baseline\*time as covariates.|MMRM|||Overall Impact Subscale: Week 4||-0.29|-2.39|0.018
72410525|NCT03056690|144329446|SUPERIORITY||LSMean Difference|-0.86|STANDARD_ERROR_OF_MEAN|0.7||0.111|TWO_SIDED|90.0|-2.02|0.3||MMRM analysis model is performed with change from baseline (Weeks 2, 4, and 8) as response; treatment, center (pooled where necessary), time (Weeks 2, 4 and 8), treatment\*time as fixed effects, baseline and baseline\*time as covariates.|MMRM|||Overall Impact Subscale: Week 8||0.30|-2.02|0.111
72410526|NCT03056690|144329447|SUPERIORITY||LSMean difference|-3.15|STANDARD_ERROR_OF_MEAN|2.36||0.092|TWO_SIDED|90.0|-7.05|0.75||ANCOVA model is performed with change from baseline at the EOT timepoint as response treatment and center (pooled where necessary) as fixed effects and baseline as a covariate.|ANCOVA|||Function Subscale||0.75|-7.05|0.092
72410527|NCT03056690|144329447|SUPERIORITY||LSMean difference|-3.29|STANDARD_ERROR_OF_MEAN|2.16||0.065|TWO_SIDED|90.0|-6.85|0.28||ANCOVA model is performed with change from baseline at the EOT timepoint as response treatment and center (pooled where necessary) as fixed effects and baseline as a covariate.|ANCOVA|||Symptoms subscale||0.28|-6.85|0.065
72410528|NCT03056690|144329447|SUPERIORITY||LSMean difference|-1.08|STANDARD_ERROR_OF_MEAN|0.65||0.049|TWO_SIDED|90.0|-2.15|-0.01||ANCOVA model is performed with change from baseline at the EOT timepoint as response treatment and center (pooled where necessary) as fixed effects and baseline as a covariate.|ANCOVA|||Overall Impact Subscale.||-0.01|-2.15|0.049
72410529|NCT03056690|144329448|SUPERIORITY|The 90% 2-sided CI is based on profile likelihood and 2-sided p-value is based on likelihood test. p-value is for the comparison of ASP0819 15 mg with Placebo from the above described proportional odds model.|Odds Ratio (OR)|1.43||||0.192|TWO_SIDED|90.0|0.91|2.24|||Likelihood test|||Week 2||2.24|0.91|0.192
72577335|NCT03743415|144681369|SUPERIORITY|The key parameter was the coefficient for the trial arm difference at week 17 in linear mixed effects model.|Mean Difference (Final Values)|-0.31|STANDARD_ERROR_OF_MEAN|1.87||0.86|TWO_SIDED|95.0|-3.98|3.34||P-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was .05.|Mixed Models Analysis|Baseline value of the outcome was adjusted for in the model.|Mean of SMSH minus SMSH+TIPC.|The null hypothesis was that the means of two groups were equal. The alternative hypothesis was that the means of two groups were not equal. Sample size was determined by the power calculation for the primary outcome.||3.34|-3.98|.86
72410530|NCT03056690|144329448|SUPERIORITY||Odds Ratio (OR)|1.33||||0.285|TWO_SIDED|90.0|0.86|2.07||The 90% 2-sided CI is based on profile likelihood and 2-sided p-value is based on likelihood test. p-value is for the comparison of ASP0819 15 mg with Placebo from the above described proportional odds model.|Likelihod test|||Week 4||2.07|0.86|0.285
72410531|NCT03056690|144329448|SUPERIORITY||Odds Ratio (OR)|1.2||||0.486|TWO_SIDED|90.0|0.78|1.87||The 90% 2-sided CI is based on profile likelihood and 2-sided p-value is based on likelihood test. p-value is for the comparison of ASP0819 15 mg with Placebo from the above described proportional odds model.|Likelihood test|||EOT||1.87|0.78|0.486
72410532|NCT03056690|144329449|SUPERIORITY|The 90% 2-sided CI is based on profile likelihood and 2-sided p-value is based on likelihood test.|Odds Ratio (OR)|1.32||||0.305|TWO_SIDED|90.0|0.85|2.05|||Likelihood test|||Week 8||2.05|0.85|0.305
72628583|NCT02949011|144785043|SUPERIORITY|||||||0.5466||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 5||||0.5466
72628584|NCT02949011|144785043|SUPERIORITY|||||||0.0543||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 6||||0.0543
72628585|NCT02949011|144785043|SUPERIORITY|||||||0.4677||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 6||||0.4677
72628586|NCT02949011|144785043|SUPERIORITY|||||||0.0266||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 9||||0.0266
72410533|NCT01767116|144329459|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The noninferiority of the rate of sustained virologic response at 12 weeks after treatment for the ABT-450/r/ABT-267 and ABT-333, plus placebo RBV treatment group as compared with the historical rate for telaprevir plus pegIFN-RBV was analyzed; the lower confidence bound of the 2-sided 95% confidence interval (95% CI) for the percentage of participants with sustained virologic response at 12 weeks after treatment must exceed 73% to achieve noninferiority.|Percentage of Participants|100.0|||||TWO_SIDED|95.0|98.2|100.0|||||95% CI was calculated using the Wilson score method for the single proportion because the point estimate was 100%..|For the primary efficacy endpoint of sustained virologic response at 12 weeks after treatment, based on a 2-sided significance level of 0.05 and an underlying rate of 92% or higher in each arm, a sample size of 200 participants per treatment arm provides \>95% power to demonstrate noninferiority of each regimen to the historical rate for telaprevir plus pegIFN and RBV therapy (84%) (based on the normal approximation of a single binomial proportion in a one-sample test for superiority).||100.0|98.2|
72410534|NCT01767116|144329459|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The noninferiority of the rate of sustained virologic response at 12 weeks after treatment for the ABT-450/r/ABT-267 and ABT-333, plus RBV treatment group as compared with the historical rate for telaprevir plus pegIFN-RBV was analyzed; the lower confidence bound of the 2-sided 95% CI for the percentage of participants with sustained virologic response at 12 weeks after treatment must exceed 73% to achieve noninferiority.|Percentage of Participants|99.5|||||TWO_SIDED|95.0|98.6|100.0|||||95% CI was calculated using the normal approximation to the binomial distribution.|For the primary efficacy endpoint of sustained virologic response at 12 weeks after treatment, based on a 2-sided significance level of 0.05 and an underlying rate of 92% or higher in each arm, a sample size of 200 participants per treatment arm provides \>95% power to demonstrate noninferiority of each regimen to the historical rate for telaprevir plus pegIFN and RBV therapy (84%) (based on the normal approximation of a single binomial proportion in a one-sample test for superiority).||100.0|98.6|
72410535|NCT01767116|144329460|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Noninferiority of the rate of sustained virologic response at 12 weeks after treatment for the ABT-450/r/ABT-267 and ABT-333, plus placebo RBV treatment group as compared with the ABT-450/r/ABT-267 and ABT-333, plus RBV treatment group was analyzed using a noninferiority margin of -10.5%. The lower confidence bound of the 2-sided 95% CI for the difference in percentage of participants with sustained virologic response at 12 weeks after treatment must exceed -10.5% to achieve noninferiority.|Difference in Percentage of Participants|0.5|||||TWO_SIDED|95.0|-0.5|1.4|||||95% CI was calculated using the normal approximation to the binomial distribution.|For the secondary efficacy endpoint of sustained virologic response at 12 weeks after treatment, based on a -10% margin, a 2-sided significance level of 0.05 and an underlying rate of 92% or higher in each arm, a sample size of 200 participants per arm provides \>95% power to demonstrate noninferiority of ABT-450/r/ABT-267 and ABT-333, plus Placebo RBV compared with ABT-450/r/ABT-267 and ABT-333, plus RBV (normal approximation of a single binomial proportion in a 1-sample test for superiority).||1.4|-0.5|
72410536|NCT01767116|144329461|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Fisher Exact|||||||<0.001
72542727|NCT02092961|144615595|SUPERIORITY_OR_OTHER||Treatment difference|0.0||||0.746|TWO_SIDED|90.0|-1.0|0.5||A negative value for change from baseline in OMERACT RAMRIS osteitis score indicates a better clinical condition.|Van Elteren|Estimated using the Van Elteren test stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant).|The point estimate for the median difference in change from baseline and associated 90% CI was calculated using the method of unstratified Hodges-Lehmann. A treatment difference \<0 indicates a benefit towards fostamatinib.|6 weeks||0.50|-1.00|0.746
72542728|NCT02092961|144615595|SUPERIORITY_OR_OTHER||Treatment difference|1.0||||0.413|TWO_SIDED|90.0|-1.5|3.5||A negative value for change from baseline in OMERACT RAMRIS synovitis score indicates a better clinical condition.|Van Elteren|Estimated using the Van Elteren test stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant).|The point estimate for the median difference in change from baseline and associated 90% CI was calculated using the method of unstratified Hodges-Lehmann. A treatment difference \<0 indicates a benefit towards fostamatinib.|24 weeks||3.50|-1.50|0.413
72542729|NCT02092961|144615596|SUPERIORITY_OR_OTHER||Treatment difference|0.0||||0.491|TWO_SIDED|90.0|0.0|0.0||A negative value for change from baseline in JSN score indicates a better clinical condition.|Van Elteren|Estimated using the Van Elteren test stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant).|The point estimate for the median difference in change from baseline and associated 90% CI was calculated using the method of unstratified Hodges-Lehmann. A treatment difference \<0 indicates a benefit towards fostamatinib.|6 weeks||0.00|0.00|0.491
72542730|NCT02092961|144615596|SUPERIORITY_OR_OTHER||Treatment difference|0.0||||0.341|TWO_SIDED|90.0|0.0|0.0||A negative value for change from baseline in JSN score indicates a better clinical condition.|Van Elteren|Estimated using the Van Elteren test stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant).|The point estimate for the median difference in change from baseline and associated 90% CI was calculated using the method of unstratified Hodges-Lehmann. A treatment difference \<0 indicates a benefit towards fostamatinib.|24 weeks||0.00|0.00|0.341
72542731|NCT02092961|144615597|SUPERIORITY_OR_OTHER||Treatment difference|0.0||||0.366|TWO_SIDED|90.0|-0.5|0.0||A negative value for change from baseline in OMERACT RAMRIS erosions score indicates a better clinical condition.|Van Elteren|Estimated using the Van Elteren test stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant).|The point estimate for the median difference in change from baseline and associated 90% CI was calculated using the method of unstratified Hodges-Lehmann. A treatment difference \<0 indicates a benefit towards fostamatinib.|6 weeks||0.00|-0.50|0.366
72542732|NCT02092961|144615597|SUPERIORITY_OR_OTHER||Treatment difference|1.25||||0.053|TWO_SIDED|90.0|0.5|2.5||A negative value for change from baseline in OMERACT RAMRIS erosions score indicates a better clinical condition.|Van Elteren|Estimated using the Van Elteren test stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant).|The point estimate for the median difference in change from baseline and associated 90% CI was calculated using the method of unstratified Hodges-Lehmann. A treatment difference \<0 indicates a benefit towards fostamatinib.|24 weeks||2.50|0.50|0.053
72628587|NCT02949011|144785043|SUPERIORITY|||||||0.1281||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 9||||0.1281
72410537|NCT01767116|144329462|SUPERIORITY_OR_OTHER_LEGACY||Percentage of Participants|100.0|||||TWO_SIDED|95.0|98.2|100.0|||||95% CI calculated using the Wilson score method for the single proportion; the lower confidence bound for the percentage of participants with sustained virologic response at 12 weeks after treatment must exceed 84% to achieve superiority.|For the secondary efficacy endpoint of sustained virologic response at 12 weeks after treatment, based on a 2-sided significance level of 0.05 and an underlying rate of 92% or higher in each arm, a sample size of 200 participants per treatment arm provides \>90% power to demonstrate superiority of each regimen to the historical rate for telaprevir plus pegIFN and RBV therapy (84%) (based on the normal approximation of a single binomial proportion in a one-sample test for superiority).||100.0|98.2|
72410538|NCT01767116|144329462|SUPERIORITY_OR_OTHER_LEGACY||Percentage of Participants|99.5|||||TWO_SIDED|95.0|98.6|100.0|||||95% CI calculated using the normal approximation to the binomial distribution; the lower confidence bound for the percentage of participants with sustained virologic response at 12 weeks after treatment must exceed 84% to achieve superiority.|For the secondary efficacy endpoint of sustained virologic response at 12 weeks after treatment, based on a 2-sided significance level of 0.05 and an underlying rate of 92% or higher in each arm, a sample size of 200 participants per treatment arm provides \>90% power to demonstrate superiority of each regimen to the historical rate for telaprevir plus pegIFN and RBV therapy (84%) (based on the normal approximation of a single binomial proportion in a one-sample test for superiority).||100.0|98.6|
72410539|NCT01242527|144329465|SUPERIORITY_OR_OTHER||Placebo adjusted % change from baseline|-21.68||||0.005|TWO_SIDED|95.0|-40.7|-2.89||P-value adjusted with Dunnett's procedure for multiple comparisons of Epanova vs olive oil|ANCOVA p-value on ranked data|ANCOVA model with baseline value as covariate, and treatment and user/non-user of lipid-altering drugs as factors|ANCOVA on log-scale TG with baseline value as covariate and treatment and user/non-user of lipid-altering drugs as factors|||-2.89|-40.70|0.005
72542733|NCT02092961|144615598|SUPERIORITY_OR_OTHER||Least Square Mean Treatment Difference|0.89||||0.006|TWO_SIDED|90.0|0.36|1.41|||ANCOVA|Includes terms for baseline as a continuous covariate and treatment and DMARD naivety (DMARD naive vs DMARD-IR/intolerant) as factors.||Change from baseline at Week 6. Nonresponder imputation applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of parenteral steroids, or for patients with no post baseline data. Patients who prematurely withdrew due to project closure have no imputation applied.||1.41|0.36|0.006
72628588|NCT02949011|144785044|SUPERIORITY||||||<|0.0001||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 2||||<0.0001
72628589|NCT02949011|144785044|SUPERIORITY||||||<|0.0001||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 2||||<0.0001
72628590|NCT02949011|144785044|SUPERIORITY||||||<|0.0001||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 3||||<0.0001
72628591|NCT02949011|144785044|SUPERIORITY|||||||0.0015||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 3||||0.0015
72410540|NCT01242527|144329465|SUPERIORITY_OR_OTHER||Placebo adjusted % change from baseline|-21.19||||0.007|TWO_SIDED|95.0|-40.32|-2.29||P-value adjusted with Dunnett's procedure for multiple comparisons of Epanova vs olive oil|ANCOVA p-value on ranked data|ANCOVA model with baseline value as covariate, and treatment and user/non-user of lipid-altering drugs as factors|ANCOVA on log-scale TG with baseline value as covariate, and treatment and user/non-user of lipid-altering drugs as factors|||-2.29|-40.32|0.007
72410541|NCT01242527|144329465|SUPERIORITY_OR_OTHER||Placebo adjusted % change from baseline|-26.6|||<|0.001|TWO_SIDED|95.0|-45.12|-8.38||P-value adjusted with Dunnett's procedure for multiple comparisons of Epanova vs olive oil|ANCOVA p-value on ranked data|ANCOVA model with baseline value as covariate, and treatment and user/non-user of lipid-altering drugs as factors|ANCOVA on log-scale TG with baseline value as covariate, and treatment and user/non-user of lipid-altering drugs as factors|||-8.38|-45.12|<0.001
72542734|NCT02092961|144615598|SUPERIORITY_OR_OTHER||Least Square Mean Treatment Difference|-0.34||||0.496|TWO_SIDED|90.0|-1.16|0.49|||ANCOVA|Includes terms for baseline as a continuous covariate and treatment and DMARD naivety (DMARD naive vs DMARD-IR/intolerant) as factors.||Change from baseline at Week 24. Nonresponder imputation applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of parenteral steroids, or for patients with no post baseline data. Patients who prematurely withdrew due to project closure have no imputation applied.||0.49|-1.16|0.496
72628592|NCT02949011|144785044|SUPERIORITY|||||||0.0028||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 4||||0.0028
72628593|NCT02949011|144785044|SUPERIORITY|||||||0.0265||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 4||||0.0265
72628594|NCT02949011|144785044|SUPERIORITY|||||||0.0247||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 5||||0.0247
72628595|NCT02949011|144785044|SUPERIORITY|||||||0.5298||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 5||||0.5298
72628596|NCT02949011|144785044|SUPERIORITY|||||||0.9554||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 6||||0.9554
72628597|NCT02949011|144785044|SUPERIORITY|||||||0.9075||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 6||||0.9075
72628598|NCT02949011|144785044|SUPERIORITY|||||||0.7624||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 9||||0.7624
72628599|NCT02949011|144785044|SUPERIORITY|||||||0.6156||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 9||||0.6156
72628600|NCT02949011|144785045|SUPERIORITY|||||||0.034||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||||||0.0340
72410542|NCT01975389|144329476|SUPERIORITY||Hazard Ratio (HR)|0.79||||0.021469|TWO_SIDED|95.0|0.65|0.97|||Log Rank|||Hazard ratio and 95% Confidence Interval (CI) were obtained from a Cox proportional hazards model stratified by geographic region and complete statin intolerance with treatment as a covariate.||0.97|0.65|0.021469
72628601|NCT02949011|144785045|SUPERIORITY|||||||0.2766||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||||||0.2766
72628602|NCT02949011|144785046|SUPERIORITY|||||||0.0072||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||||||0.0072
72628603|NCT02949011|144785046|SUPERIORITY|||||||0.733||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||||||0.7330
72410543|NCT01975389|144329477|SUPERIORITY||Hazard Ratio (HR)|0.75||||0.007597|TWO_SIDED|95.0|0.6|0.93|||Log Rank|||Hazard ratio and 95% CI were obtained from a Cox proportional hazards model stratified by geographic region and complete statin intolerance with treatment as a covariate.||0.93|0.60|0.007597
72410544|NCT01975389|144329478|SUPERIORITY||Hazard Ratio (HR)|0.82||||0.035958|TWO_SIDED|95.0|0.68|0.99|||Log Rank|||Hazard ratio and 95% CI were obtained from a Cox proportional hazards model stratified by geographic region and complete statin intolerance with treatment as a covariate.||0.99|0.68|0.035958
72410545|NCT01975389|144329479|SUPERIORITY||Hazard Ratio (HR)|0.78||||0.015694|TWO_SIDED|95.0|0.64|0.95|||Log Rank|||Hazard ratio and 95% CI were obtained from a Cox proportional hazards model stratified by geographic region and complete statin intolerance with treatment as a covariate.||0.95|0.64|0.015694
72410546|NCT01975389|144329480|SUPERIORITY||Hazard Ratio (HR)|0.95||||0.814224|TWO_SIDED|95.0|0.62|1.46|||Log Rank|||Hazard ratio and 95% CI were obtained from a Cox proportional hazards model stratified by geographic region and complete statin intolerance with treatment as a covariate.||1.46|0.62|0.814224
72410547|NCT01975389|144329481|SUPERIORITY||Hazard Ratio (HR)|0.79||||0.018053|TWO_SIDED|95.0|0.65|0.96|||Log Rank|||Hazard ratio and 95% CI were obtained from a Cox proportional hazards model stratified by geographic region and complete statin intolerance with treatment as a covariate.||0.96|0.65|0.018053
72628604|NCT02949011|144785047|SUPERIORITY||Median Difference|-48.0|||<|0.0001|TWO_SIDED|95.0|-48.0|-48.0||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Peto-Prentice's generalized Wilcoxon test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region||||-48.0|-48.0|<0.0001
72628605|NCT02949011|144785047|SUPERIORITY||Median Difference|-48.0|||<|0.0001|TWO_SIDED|95.0|-48.0|-24.0||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Peto-Prentice's generalized Wilcoxon test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region||||-24.0|-48.0|<0.0001
72628606|NCT02949011|144785048|SUPERIORITY||Median Difference|-24.0||||0.0006|TWO_SIDED|95.0|-96.0|0.0||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Peto-Prentice's generalized Wilcoxon test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region||||0.0|-96.0|0.0006
72628607|NCT02949011|144785048|SUPERIORITY||Median Difference|0.0||||0.237|TWO_SIDED|95.0|-48.0|24.0||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Peto-Prentice's generalized Wilcoxon test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region||||24.0|-48.0|0.2370
72628608|NCT02949011|144785049|SUPERIORITY|||||||0.7698||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||12 hours||||0.7698
72628609|NCT02949011|144785049|SUPERIORITY|||||||0.5777||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||12 hours||||0.5777
72628610|NCT02949011|144785049|SUPERIORITY|||||||0.1112||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||24 hours||||0.1112
72628611|NCT02949011|144785049|SUPERIORITY|||||||0.6483||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||24 hours||||0.6483
72628612|NCT02949011|144785049|SUPERIORITY|||||||0.0004||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||36 hours||||0.0004
72628613|NCT02949011|144785049|SUPERIORITY|||||||0.5625||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||36 hours||||0.5625
72410548|NCT01975389|144329482|SUPERIORITY||Hazard Ratio (HR)|0.82||||0.446033|TWO_SIDED|95.0|0.5|1.36|||Log Rank|||Hazard ratio and 95% CI were obtained from a Cox proportional hazards model stratified by geographic region and complete statin intolerance with treatment as a covariate.||1.36|0.50|0.446033
72410549|NCT01975389|144329483|SUPERIORITY||Hazard Ratio (HR)|0.75||||0.029977|TWO_SIDED|95.0|0.57|0.97|||Log Rank|||Hazard ratio and 95% CI were obtained from a Cox proportional hazards model stratified by geographic region and complete statin intolerance with treatment as a covariate.||0.97|0.57|0.029977
72410550|NCT01975389|144329484|SUPERIORITY||Hazard Ratio (HR)|0.44||||0.162615|TWO_SIDED|95.0|0.14|1.44|||Log Rank|||Hazard ratio and 95% CI were obtained from a Cox proportional hazards model stratified by geographic region and complete statin intolerance with treatment as a covariate.||1.44|0.14|0.162615
72410551|NCT01975389|144329485|SUPERIORITY||Hazard Ratio (HR)|0.77||||0.051534|TWO_SIDED|95.0|0.59|1.0|||Log Rank|||Hazard ratio and 95% CI were obtained from a Cox proportional hazards model stratified by geographic region and complete statin intolerance with treatment as a covariate.||1.00|0.59|0.051534
72410552|NCT01975389|144329486|SUPERIORITY||Hazard Ratio (HR)|0.67||||0.104998|TWO_SIDED|95.0|0.41|1.09|||Log Rank|||Hazard ratio and 95% CI were obtained from a Cox proportional hazards model stratified by geographic region and complete statin intolerance with treatment as a covariate.||1.09|0.41|0.104998
72410553|NCT01975389|144329487|SUPERIORITY||Hazard Ratio (HR)|0.78||||0.294331|TWO_SIDED|95.0|0.5|1.24|||Log Rank|||Hazard ratio and 95% CI were obtained from a Cox proportional hazards model stratified by geographic region and complete statin intolerance with treatment as a covariate.||1.24|0.50|0.294331
72410554|NCT01975389|144329489|SUPERIORITY||Hazard Ratio (HR)|0.67||||0.104998|TWO_SIDED|95.0|0.41|1.09|||Log Rank|||Hazard ratio and 95% CI were obtained from a Cox proportional hazards model stratified by geographic region and complete statin intolerance with treatment as a covariate.||1.09|0.41|0.104998
72410555|NCT01975389|144329490|SUPERIORITY||Hazard Ratio (HR)|0.9||||0.6012|TWO_SIDED|95.0|0.6|1.34|||Log Rank|||Hazard ratio and 95% CI were obtained from a Cox proportional hazards model stratified by geographic region and complete statin intolerance with treatment as a covariate.||1.34|0.60|0.601200
72410556|NCT01975389|144329491|SUPERIORITY||Hazard Ratio (HR)|1.09||||0.678061|TWO_SIDED|95.0|0.72|1.67|||Log Rank|||Hazard ratio and 95% CI were obtained from a Cox proportional hazards model stratified by geographic region and complete statin intolerance with treatment as a covariate.||1.67|0.72|0.678061
72410557|NCT01975389|144329492|SUPERIORITY||Hazard Ratio (HR)|0.77||||0.010457|TWO_SIDED|95.0|0.63|0.94|||Log Rank|||Hazard ratio and 95% CI were obtained from a Cox proportional hazards model stratified by geographic region and complete statin intolerance with treatment as a covariate.||0.94|0.63|0.010457
72410558|NCT01975389|144329493|SUPERIORITY||Hazard Ratio (HR)|1.19||||0.509847|TWO_SIDED|95.0|0.71|2.01|||Log Rank|||Hazard ratio and 95% CI were obtained from a Cox proportional hazards model stratified by geographic region and complete statin intolerance with treatment as a covariate.||2.01|0.71|0.509847
72410559|NCT01975389|144329494|SUPERIORITY||Hazard Ratio (HR)|0.72||||0.002981|TWO_SIDED|95.0|0.58|0.9|||Log Rank|||Hazard ratio and 95% CI were obtained from a Cox proportional hazards model stratified by geographic region and complete statin intolerance with treatment as a covariate.||0.90|0.58|0.002981
72410560|NCT01975389|144329495|SUPERIORITY||Hazard Ratio (HR)|0.95||||0.748975|TWO_SIDED|95.0|0.7|1.3|||Log Rank|||Hazard ratio and 95% CI were obtained from a Cox proportional hazards model stratified by geographic region and complete statin intolerance with treatment as a covariate.||1.30|0.70|0.748975
72410561|NCT01975389|144329496|SUPERIORITY||Hazard Ratio (HR)|0.91||||0.626157|TWO_SIDED|95.0|0.63|1.32|||Log Rank|||Hazard ratio and 95% CI were obtained from a Cox proportional hazards model stratified by geographic region and complete statin intolerance with treatment as a covariate.||1.32|0.63|0.626157
72410562|NCT01975389|144329497|SUPERIORITY||LS mean difference|-56.9|STANDARD_ERROR_OF_MEAN|0.51|<|0.001|TWO_SIDED|95.0|-57.91|-55.89|||MMRM|||Least square (LS) mean differences, associated 95% CI, and p-values were from an mixed model repeated measures (MMRM) model including observations through Week 70 with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographic region and complete statin intolerance.||-55.89|-57.91|<0.001
72410563|NCT01975389|144329498|SUPERIORITY||LS mean difference|-73.8|STANDARD_ERROR_OF_MEAN|0.67|<|0.001|TWO_SIDED|95.0|-75.11|-72.5|||MMRM|||LS mean differences, associated 95% CI, and p-values were from an MMRM model including observations through Week 70 with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographic region and complete statin intolerance.||-72.50|-75.11|<0.001
72410564|NCT01975389|144329499|SUPERIORITY||LS mean difference|-39.31|STANDARD_ERROR_OF_MEAN|0.64|<|0.001|TWO_SIDED|95.0|-40.55|-38.06|||ANCOVA|||LS-mean difference, associated 95% CI, and p-value were from an analysis of covariance (ANCOVA) model with fixed effects for treatment group, baseline value, geographic region and complete statin intolerance.||-38.06|-40.55|<0.001
72410565|NCT01975389|144329500|SUPERIORITY||LS mean difference|-51.87|STANDARD_ERROR_OF_MEAN|0.48|<|0.001|TWO_SIDED|95.0|-52.81|-50.94|||MMRM|||Non-HDLC: LS-mean differences, associated 95% CI, and p-values were from an MMRM model including observations through Week 70 with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographic region and complete statin intolerance.||-50.94|-52.81|<0.001
72410566|NCT01975389|144329500|SUPERIORITY||LS mean difference|-18.41|STANDARD_ERROR_OF_MEAN|0.79|<|0.001|TWO_SIDED|95.0|-19.96|-16.86|||MMRM|||VLDL-C: LS-mean differences, associated 95% CI, and p-values were from an MMRM model including observations through Week 70 with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographic region and complete statin intolerance.||-16.86|-19.96|<0.001
72410567|NCT01975389|144329500|SUPERIORITY||LS mean difference|-29.2|STANDARD_ERROR_OF_MEAN|1.14|<|0.001|TWO_SIDED|95.0|-31.44|-26.96|||MMRM|||RLP-C: LS-mean differences, associated 95% CI, and p-values were from an MMRM model including observations through Week 70 with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographic region and complete statin intolerance.||-26.96|-31.44|<0.001
72542735|NCT01663714|144615652|SUPERIORITY_OR_OTHER||percentage of participants|100.0|||||TWO_SIDED|95.0|100.0|100.0|||||The estimated value represents the percentage of participants with unconfirmed response.|||100|100|
72542736|NCT01663714|144615653|SUPERIORITY_OR_OTHER||percentage of participants|100.0|||||TWO_SIDED|95.0|100.0|100.0|||||The estimated value represents the percentage of participants with confirmed response.|||100|100|
72542737|NCT00597584|144615674|NON_INFERIORITY_OR_EQUIVALENCE|A non-inferiority margin of -1.0 g/dL was used in the primary efficacy assessments. Non-inferiority was established if the lower limit of the two-sided 95% confidence interval for the difference between the means of the primary endpoint (peginesatide minus control ESA) was ≥ -1.0 g/dL.|Least Squares Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.078|||TWO_SIDED|95.0|-0.05|0.26|||ANOVA|The ANOVA cell means model was used to estimate primary efficacy endpoint within the specified cells formed by the combination of treatment and strata||The sample size for this study has been determined based on a two group evaluation of non-inferiority using the t-distribution (one-sided significance level 0.025) with a non inferiority margin of -1.0 g/dL. A sample size of approximately 750 (peginesatide group of 500 and epoetin group of 250) provided at least 99% power for the evaluation of non-inferiority, assuming an expected treatment difference of 0.0 g/dL and a standard deviation of 1.5 g/dL.||0.26|-0.05|
72542738|NCT00597584|144615675|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.79|||||TWO_SIDED|95.0|0.5|1.24|||Cochran-Mantel-Haenszel|||||1.24|0.50|
72542739|NCT00597584|144615676|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.96|||||TWO_SIDED|95.0|0.87|1.07|||Cochran-Mantel-Haenszel|||||1.07|0.87|
72542740|NCT01294592|144615684|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-2.2|STANDARD_ERROR_OF_MEAN|0.28|<|0.001|TWO_SIDED|95.0|-2.8|-1.7||Month 1|t-test, 2 sided|Values are based on t-tests from the general linear model|Estimates are based on the adjusted means from the general linear model: Change from Baseline = Treatment + Cluster + Baseline Value. The adjusted mean difference is based on dutasteride plus tamsulosin minus Watchful Waiting All.|||-1.7|-2.8|<0.001
72542741|NCT01294592|144615684|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-2.1|STANDARD_ERROR_OF_MEAN|0.31|<|0.001|TWO_SIDED|95.0|-2.7|-1.5||Month 3|t-test, 2 sided|Values are based on t-tests from the general linear model|Estimates are based on the adjusted means from the general linear model: Change from Baseline = Treatment + Cluster + Baseline Value. The adjusted mean difference is based on dutasteride plus tamsulosin minus Watchful Waiting All.|||-1.5|-2.7|<0.001
72542742|NCT01294592|144615684|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.5|STANDARD_ERROR_OF_MEAN|0.31|<|0.001|TWO_SIDED|95.0|-2.1|-0.9||Month 6|t-test, 2 sided|Values are based on t-tests from the general linear model|Estimates are based on the adjusted means from the general linear model: Change from Baseline = Treatment + Cluster + Baseline Value. The adjusted mean difference is based on dutasteride plus tamsulosin minus Watchful Waiting All.|||-0.9|-2.1|<0.001
72542743|NCT01294592|144615684|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.6|STANDARD_ERROR_OF_MEAN|0.31|<|0.001|TWO_SIDED|95.0|-2.2|-1.0||Month 9|t-test, 2 sided|Values are based on t-tests from the general linear model|Estimates are based on the adjusted means from the general linear model: Change from Baseline = Treatment + Cluster + Baseline Value. The adjusted mean difference is based on dutasteride plus tamsulosin minus Watchful Waiting All.|||-1.0|-2.2|<0.001
72542744|NCT01294592|144615684|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.6|STANDARD_ERROR_OF_MEAN|0.32|<|0.001|TWO_SIDED|95.0|-2.2|-1.0||Month 12|t-test, 2 sided|Values are based on t-tests from the general linear model|Estimates are based on the adjusted means from the general linear model: Change from Baseline = Treatment + Cluster + Baseline Value. The adjusted mean difference is based on dutasteride plus tamsulosin minus Watchful Waiting All.|||-1.0|-2.2|<0.001
72542745|NCT01294592|144615684|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.6|STANDARD_ERROR_OF_MEAN|0.34|<|0.001|TWO_SIDED|95.0|-2.3|-1.0||Month 15|t-test, 2 sided|Values are based on t-tests from the general linear model|Estimates are based on the adjusted means from the general linear model: Change from Baseline = Treatment + Cluster + Baseline Value. The adjusted mean difference is based on dutasteride plus tamsulosin minus Watchful Waiting All.|||-1.0|-2.3|<0.001
72542746|NCT01294592|144615684|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.7|STANDARD_ERROR_OF_MEAN|0.35|<|0.001|TWO_SIDED|95.0|-2.4|-1.0||Month 18|t-test, 2 sided|Values are based on t-tests from the general linear model|Estimates are based on the adjusted means from the general linear model: Change from Baseline = Treatment + Cluster + Baseline Value. The adjusted mean difference is based on dutasteride plus tamsulosin minus Watchful Waiting All.|||-1.0|-2.4|<0.001
72542747|NCT01294592|144615684|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.9|STANDARD_ERROR_OF_MEAN|0.34|<|0.001|TWO_SIDED|95.0|-2.5|-1.2||Month 21|t-test, 2 sided|Values are based on t-tests from the general linear model|Estimates are based on the adjusted means from the general linear model: Change from Baseline = Treatment + Cluster + Baseline Value. The adjusted mean difference is based on dutasteride plus tamsulosin minus Watchful Waiting All.|||-1.2|-2.5|<0.001
72542748|NCT01294592|144615684|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.8|STANDARD_ERROR_OF_MEAN|0.34|<|0.001|TWO_SIDED|95.0|-2.5|-1.2||Month 24|t-test, 2 sided|Values are based on t-tests from the general linear model|Estimates are based on the adjusted means from the general linear model: Change from Baseline = Treatment + Cluster + Baseline Value. The adjusted mean difference is based on dutasteride plus tamsulosin minus Watchful Waiting All.|||-1.2|-2.5|<0.001
72542749|NCT03549130|144615695|SUPERIORITY||Least Square (LS) mean difference|-0.77||||0.2446|TWO_SIDED|95.0|-2.06|0.53||Between treatment p-values.|ANCOVA|Treatment,site used as factors;following variables as covariate:baseline, age,level of congestion symptoms at baseline,Berlin score,Epworth sleepiness|Difference between treatments of adjusted mean change from baseline.|Treatment comparison of NRQLQ between active and placebo strip group for Sleep problems.||0.53|-2.06|0.2446
72577336|NCT01701011|144681370|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Mixed Models Analysis|||IBM SPSS Statistics 20 was used to perform the statistical analysis. A mixed model for repeated measures was used to examine the differences between the three groups over time for the primary outcome, anxiety. All models were estimated by the method of restricted maximum likelihood (REML) and the Compound Symmetry covariance structure was chosen for the repeated measures. The analysiswas performed according to the intention to treat.||||<0.05
72577337|NCT01701011|144681370|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Mixed Models Analysis|||To test the difference in psychological well-being between three groups with a power of 95%,a ¼ 0.05 and a medium effect size ( f ¼ 0.25), a total of 297 participants were required (99 patients per group). Taking into account a 20% attrition rate, at least 124 women had to be recruited in each group.||||<0.05
72628614|NCT02949011|144785049|SUPERIORITY|||||||0.0072||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||48 hours||||0.0072
72410568|NCT01975389|144329500|SUPERIORITY||LS mean difference|-51.4|STANDARD_ERROR_OF_MEAN|0.5|<|0.001|TWO_SIDED|95.0|-52.37|-50.42|||MMRM|||Apo B: LS-mean differences, associated 95% CI, and p-values were from an MMRM model including observations through Week 52 with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographic region and complete statin intolerance.||-50.42|-52.37|<0.001
72410569|NCT01975389|144329500|SUPERIORITY||LS mean difference|6.91|STANDARD_ERROR_OF_MEAN|0.3|<|0.001|TWO_SIDED|95.0|6.33|7.5|||MMRM|||HDL-C: LS-mean differences, associated 95% CI, and p-values were from an MMRM model including observations through Week 70 with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographic region and complete statin intolerance.||7.50|6.33|<0.001
72410570|NCT01975389|144329500|SUPERIORITY||LS mean difference|4.4|STANDARD_ERROR_OF_MEAN|0.25|<|0.001|TWO_SIDED|95.0|3.9|4.9|||MMRM|||Apo A-I: LS-mean differences, associated 95% CI, and p-values were from an MMRM model including observations through Week 52 with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographic region and complete statin intolerance.||4.90|3.90|<0.001
72628615|NCT02949011|144785049|SUPERIORITY|||||||0.6234||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||48 hours||||0.6234
72628616|NCT02949011|144785049|SUPERIORITY|||||||0.0002||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||72 hours||||0.0002
72628617|NCT02949011|144785049|SUPERIORITY|||||||0.9547||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||72 hours||||0.9547
72628618|NCT02949011|144785049|SUPERIORITY|||||||0.0012||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||96 hours||||0.0012
72410571|NCT01975389|144329500|SUPERIORITY||LS mean difference|-37.99|STANDARD_ERROR_OF_MEAN|0.39|<|0.001|TWO_SIDED|95.0|-38.75|-37.22|||MMRM|||Total cholesterol: LS-mean differences, associated 95% CI, and p-values were from an MMRM model including observations through Week 70 with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographic region and complete statin intolerance.||-37.22|-38.75|<0.001
72410572|NCT01975389|144329501|SUPERIORITY||LS mean difference|0.82|||<|0.001|TWO_SIDED|95.0|0.81|0.83|||MMRM|||Triglycerides: LS-mean differences, associated 95% CI and p-values were from an MMRM model including observations through Week 70 on the difference of log-transformed observations with fixed effects for treatment group, visit, treatment group\*visit interaction, log-transformed baseline value, log-transformed baseline value\*visit interaction, geographical region and complete statin intolerance. The 95% CI was derived by exponentiating the LS-mean difference confidence interval from the log scale.||0.83|0.81|<0.001
72410573|NCT01975389|144329501|SUPERIORITY||LS mean difference|0.68|||<|0.001|TWO_SIDED|95.0|0.67|0.69|||MMRM|||Lp(a): LS-mean differences, associated 95% CI and p-values were from an MMRM model on the Difference of log-transformed observations with fixed effects for treatment group, visit, a treatment group\*visit interaction, log-transformed baseline value, log-transformed baseline value\*visit interaction, geographical region and complete statin intolerance. The 95% CI was derived by exponentiating the LS-mean difference confidence interval from the log scale.||0.69|0.67|<0.001
72410574|NCT01975389|144329502|SUPERIORITY||LS mean difference|1.06||||0.002|TWO_SIDED|95.0|1.02|1.09|||MMRM|||LS-mean differences, associated 95% CI and p-values were from an MMRM model on the difference of log-transformed observations with fixed effects for treatment group, visit, treatment group\*visit interaction, log-transformed baseline value, log-transformed baseline value\*visit interaction, geographical region and complete statin intolerance.||1.09|1.02|0.002
72628619|NCT02949011|144785049|SUPERIORITY|||||||0.186||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||96 hours||||0.1860
72628620|NCT02949011|144785049|SUPERIORITY|||||||0.0274||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||120 hours||||0.0274
72628621|NCT02949011|144785049|SUPERIORITY|||||||0.9635||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||120 hours||||0.9635
72628622|NCT02949011|144785049|SUPERIORITY|||||||0.0081||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||144 hours||||0.0081
72628623|NCT02949011|144785049|SUPERIORITY|||||||0.7425||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||144 hours||||0.7425
72628624|NCT02949011|144785049|SUPERIORITY|||||||0.0209||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||168 hours||||0.0209
72628625|NCT02949011|144785049|SUPERIORITY|||||||0.7448||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||168 hours||||0.7448
72628626|NCT02949011|144785049|SUPERIORITY|||||||0.0644||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||192 hours||||0.0644
72410575|NCT01072201|144329505|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
72628627|NCT02949011|144785049|SUPERIORITY|||||||0.4931||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||192 hours||||0.4931
72628628|NCT02949011|144785049|SUPERIORITY|||||||0.0708||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||216 hours||||0.0708
72628629|NCT02949011|144785049|SUPERIORITY|||||||0.4024||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||216 hours||||0.4024
72628630|NCT02949011|144785050|SUPERIORITY||Median Difference|-25.8|||<|0.0001||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Peto-Prentice's generalized Wilcoxon test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||||||<0.0001
72628631|NCT02949011|144785050|SUPERIORITY||Median Difference|-8.6||||0.9127||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Peto-Prentice's generalized Wilcoxon test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||||||0.9127
72628632|NCT02949011|144785051|SUPERIORITY||Median Difference|-15.1||||0.0013||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Peto-Prentice's generalized Wilcoxon test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||||||0.0013
72410576|NCT01072201|144329506|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
72410577|NCT01072201|144329507|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups||||0.05
72410578|NCT00360334|144329520|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.71|||<|0.001||95.0|2.62|8.46|||Regression, Logistic|||Odds Ratio (OR) = odds of a patient in the exenatide arm achieving the primary outcome divided by the odds of a patient in the insulin glargine arm achieving the primary outcome||8.46|2.62|<0.001
72410579|NCT00360334|144329521|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.76|||<|0.001||95.0|3.11|10.64|||Regression, Logistic|||Odds Ratio (OR) = odds of a patient in the exenatide arm achieving the secondary outcome divided by the odds of a patient in the insulin glargine arm achieving the secondary outcome||10.64|3.11|<0.001
72628633|NCT02949011|144785051|SUPERIORITY||Median Difference|2.3||||0.8498||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Peto-Prentice's generalized Wilcoxon test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||||||0.8498
72628634|NCT02949011|144785052|SUPERIORITY||Median Difference|-24.1||||0.0001||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Peto-Prentice's generalized Wilcoxon test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||||||0.0001
72628635|NCT02949011|144785052|SUPERIORITY||Median Difference|1.5||||0.9237||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Peto-Prentice's generalized Wilcoxon test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||||||0.9237
72628636|NCT02949011|144785053|SUPERIORITY||Median Difference|-19.8|||<|0.0001|TWO_SIDED|95.0|-28.8|-12.5||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Peto-Prentice's generalized Wilcoxon test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||||-12.5|-28.8|<0.0001
72628637|NCT02949011|144785053|SUPERIORITY||Median Difference|-3.5||||0.2425|TWO_SIDED|95.0|-9.1|2.7||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Peto-Prentice's generalized Wilcoxon test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||||2.7|-9.1|0.2425
72628638|NCT02949011|144785054|SUPERIORITY|||||||0.1713||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||12 hours||||0.1713
72628639|NCT02949011|144785054|SUPERIORITY|||||||0.2249||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||12 hours||||0.2249
72628640|NCT02949011|144785054|SUPERIORITY|||||||0.0387||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||24 hours||||0.0387
72628641|NCT02949011|144785054|SUPERIORITY|||||||0.3915||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||24 hours||||0.3915
72410580|NCT00360334|144329522|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||||||<0.001
72410581|NCT00360334|144329523|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.75||||0.28||95.0|0.44|1.26|||Regression, Logistic|||Odds Ratio (OR) = odds of a patient in the exenatide arm achieving the secondary outcome divided by the odds of a patient in the insulin glargine arm achieving the secondary outcome||1.26|0.44|0.280
72628642|NCT02949011|144785054|SUPERIORITY||||||<|0.0001||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||36 hours||||<0.0001
72410582|NCT00360334|144329524|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.7||||0.191||95.0|0.42|1.19|||Regression, Logistic|||Odds Ratio (OR) = odds of a patient in the exenatide arm achieving the secondary outcome divided by the odds of a patient in the insulin glargine arm achieving the secondary outcome||1.19|0.42|0.191
72410583|NCT00360334|144329525|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.43||||0.363||95.0|0.66|3.07|||Regression, Logistic|||Odds Ratio (OR) = odds of a patient in the exenatide arm achieving the secondary outcome divided by the odds of a patient in the insulin glargine arm achieving the secondary outcome||3.07|0.66|0.363
72542750|NCT03549130|144615695|SUPERIORITY||LS mean difference|-1.8||||0.0333|TWO_SIDED|95.0|-3.45|-0.14||Between treatment p-values.|ANCOVA|Treatment,site used as factors;following variables as covariate:baseline, age,level of congestion symptoms at baseline,Berlin score,Epworth sleepiness|Difference between treatments of adjusted mean change from baseline.|Treatment comparison of NRQLQ between active and placebo strip group for Sleep Time Problems.||-0.14|-3.45|0.0333
72542751|NCT03549130|144615695|SUPERIORITY||LS mean difference|-1.63||||0.0345|TWO_SIDED|95.0|-3.13|-0.12||Between treatment p-values.|ANCOVA|Treatment,site used as factors;following variables as covariate:baseline, age,level of congestion symptoms at baseline,Berlin score,Epworth sleepiness|Difference between treatments of adjusted mean change from baseline.|Treatment comparison of NRQLQ between active and placebo strip group for Symptoms on Waking in the Morning.||-0.12|-3.13|0.0345
72628643|NCT02949011|144785054|SUPERIORITY|||||||0.2617||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||36 hours||||0.2617
72542752|NCT03549130|144615695|SUPERIORITY||LS mean difference|-0.71||||0.1711|TWO_SIDED|95.0|-1.72|0.31||Between treatment p-values.|ANCOVA|Treatment,site used as factors;following variables as covariate:baseline, age,level of congestion symptoms at baseline,Berlin score,Epworth sleepiness|Difference between treatments of adjusted mean change from baseline.|Treatment comparison of NRQLQ between active and placebo strip group for Practical Problems.||0.31|-1.72|0.1711
72542753|NCT03549130|144615696|SUPERIORITY||LS mean difference|-0.47||||0.5063|TWO_SIDED|95.0|-1.85|0.92||Between treatment p-values.|ANCOVA|Treatment,site used as factors;following variables as covariate:baseline, age,level of congestion symptoms at baseline,Berlin score,Epworth sleepiness|Difference between treatments of adjusted mean change from baseline.|Treatment comparison of NRQLQ between active and placebo strip group for Sleep problems.||0.92|-1.85|0.5063
72542754|NCT03549130|144615696|SUPERIORITY||LS mean difference|-0.97||||0.2496|TWO_SIDED|95.0|-2.64|0.69||Between treatment p-values.|ANCOVA|Treatment,site used as factors;following variables as covariate:baseline, age,level of congestion symptoms at baseline,Berlin score,Epworth sleepiness|Difference between treatments of adjusted mean change from baseline.|Treatment comparison of NRQLQ between active and placebo strip group for Sleep time problems.||0.69|-2.64|0.2496
72542755|NCT03549130|144615696|SUPERIORITY||LS mean difference|-0.71||||0.3325|TWO_SIDED|95.0|-2.16|0.74||Between treatment p-values.|ANCOVA|Treatment,site used as factors;following variables as covariate:baseline, age,level of congestion symptoms at baseline,Berlin score,Epworth sleepiness|Difference between treatments of adjusted mean change from baseline.|Treatment comparison of NRQLQ between active and placebo strip group for symptoms on waking in the morning.||0.74|-2.16|0.3325
72542756|NCT03549130|144615696|SUPERIORITY||LS mean difference|-0.81||||0.1088|TWO_SIDED|95.0|-1.81|0.18||Between treatment p-values.|ANCOVA|Treatment,site used as factors;following variables as covariate:baseline, age,level of congestion symptoms at baseline,Berlin score,Epworth sleepiness|Difference between treatments of adjusted mean change from baseline.|Treatment comparison of NRQLQ between active and placebo strip group for practical problems.||0.18|-1.81|0.1088
72542757|NCT03549130|144615697|SUPERIORITY||LS mean difference|-0.25||||0.2513|TWO_SIDED|95.0|-0.68|0.18||Between treatment p-values.|ANCOVA|Treatment,site used as factors;following variables as covariate:baseline, age,level of congestion symptoms at baseline,Berlin score,Epworth sleepiness|Difference between treatments of adjusted mean change from baseline.|Treatment comparison of Symptoms on Waking in the Morning in NRQLQ between active and placebo strip group for feel tired and unrefreshed.||0.18|-0.68|0.2513
72542758|NCT03549130|144615697|SUPERIORITY||LS mean difference|-0.37||||0.0743|TWO_SIDED|95.0|-0.78|0.04||Between treatment p-values.|ANCOVA|Treatment,site used as factors;following variables as covariate:baseline, age,level of congestion symptoms at baseline,Berlin score,Epworth sleepiness|Difference between treatments of adjusted mean change from baseline.|Treatment comparison of Symptoms on Waking in the Morning in NRQLQ between active and placebo strip group for nasal congestion or stuffy nose.||0.04|-0.78|0.0743
72542759|NCT03549130|144615697|SUPERIORITY||LS mean difference|-0.55||||0.0158|TWO_SIDED|95.0|-0.99|-0.1||Between treatment p-values.|ANCOVA|Treatment,site used as factors;following variables as covariate:baseline, age,level of congestion symptoms at baseline,Berlin score,Epworth sleepiness|Difference between treatments of adjusted mean change from baseline.|Treatment comparison of Symptoms on Waking in the Morning in NRQLQ between active and placebo strip group for congestion in sinuses.||-0.10|-0.99|0.0158
72542760|NCT03549130|144615697|SUPERIORITY||LS mean difference|-0.47||||0.0489|TWO_SIDED|95.0|-0.94|0.0||Between treatment p-values.|ANCOVA|Treatment,site used as factors;following variables as covariate:baseline, age,level of congestion symptoms at baseline,Berlin score,Epworth sleepiness|Difference between treatments of adjusted mean change from baseline.|Treatment comparison of Symptoms on Waking in the Morning in NRQLQ between active and placebo strip group for time to clear nighttime drainage after waking up.||0.00|-0.94|0.0489
72542761|NCT03549130|144615698|SUPERIORITY||LS mean difference|-0.19||||0.3034|TWO_SIDED|95.0|-0.57|0.18||Between treatment p-values.|ANCOVA|Treatment,site used as factors;following variables as covariate:baseline, age,level of congestion symptoms at baseline,Berlin score,Epworth sleepiness|Difference between treatments of adjusted mean change from baseline.|Treatment comparison of Symptoms on Waking in the Morning in NRQLQ between active and placebo strip group for feel tired and unrefreshed.||0.18|-0.57|0.3034
72628644|NCT02949011|144785054|SUPERIORITY||||||<|0.0001||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||48 hours||||<0.0001
72628645|NCT02949011|144785054|SUPERIORITY|||||||0.8808||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||48 hours||||0.8808
72628646|NCT02949011|144785054|SUPERIORITY|||||||0.0001||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||72 hours||||0.0001
72628647|NCT02949011|144785054|SUPERIORITY|||||||0.5923||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||72 hours||||0.5923
72628648|NCT02949011|144785054|SUPERIORITY|||||||0.0064||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||96 hours||||0.0064
72628649|NCT02949011|144785054|SUPERIORITY|||||||0.6746||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||96 hours||||0.6746
72628650|NCT02949011|144785054|SUPERIORITY|||||||0.8167||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||120 hours||||0.8167
72628651|NCT02949011|144785054|SUPERIORITY|||||||0.3773||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||120 hours||||0.3773
72410584|NCT00360334|144329527|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Mixed Model Repeated Measures|||||||<0.001
72410585|NCT00360334|144329528|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Mixed Model Repeated Measures|||||||<0.001
72410586|NCT00360334|144329529|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Mixed Model Repeated Measures|||||||<0.001
72628652|NCT02949011|144785054|SUPERIORITY|||||||0.1041||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||144 hours||||0.1041
72628653|NCT02949011|144785054|SUPERIORITY|||||||0.3328||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||144 hours||||0.3328
72628654|NCT02949011|144785054|SUPERIORITY|||||||0.7867||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||168 hours||||0.7867
72628655|NCT02949011|144785054|SUPERIORITY|||||||0.864||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||168 hours||||0.8640
72628656|NCT02949011|144785054|SUPERIORITY|||||||0.6465||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||192 hours||||0.6465
72628657|NCT02949011|144785054|SUPERIORITY|||||||0.4265||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||192 hours||||0.4265
72628658|NCT02949011|144785054|SUPERIORITY|||||||0.6568||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||216 hours||||0.6568
72628659|NCT02949011|144785054|SUPERIORITY|||||||0.6102||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||216 hours||||0.6102
72628660|NCT02949011|144785055|SUPERIORITY||LS Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.07||0.0408|TWO_SIDED|95.0|-0.28|-0.01||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|ANCOVA with baseline composite symptom score, preexisting and worsened symptom, region, and body temperature at baseline as covariates.||12 hours||-0.01|-0.28|0.0408
72628661|NCT02949011|144785055|SUPERIORITY||LS Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.07||0.5324|TWO_SIDED|95.0|-0.18|0.09||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|ANCOVA with baseline composite symptom score, preexisting and worsened symptom, region, and body temperature at baseline as covariates.||12 hours||0.09|-0.18|0.5324
72628662|NCT02949011|144785055|SUPERIORITY||LS Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.06||0.0025|TWO_SIDED|95.0|-0.3|-0.06||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|ANCOVA with baseline composite symptom score, preexisting and worsened symptom, region, and body temperature at baseline as covariates.||24 hours||-0.06|-0.30|0.0025
72410587|NCT00360334|144329530|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Mixed Model Repeated Measures|||||||<0.001
72410588|NCT00360334|144329531|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Mixed Models Repeated Measures|||||||<0.001
72410589|NCT00360334|144329532|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|27.91||||0.001||95.0|3.7|210.54|||Regression, Logistic|||Odds Ratio (OR) = odds of a patient in the exenatide arm achieving the secondary outcome divided by the odds of a patient in the insulin glargine arm achieving the secondary outcome||210.54|3.70|0.001
72410590|NCT00360334|144329534|SUPERIORITY_OR_OTHER|||||||0.014||95.0|||||Mixed Model Repeated Measures|||||||0.014
72410591|NCT00360334|144329535|SUPERIORITY_OR_OTHER|||||||0.1||95.0|||||Mixed Model Repeated Measures|||||||0.100
72410592|NCT00360334|144329536|SUPERIORITY_OR_OTHER|||||||0.125||95.0|||||ANCOVA|||||||0.125
72410593|NCT00360334|144329537|SUPERIORITY_OR_OTHER|||||||0.471||95.0|||||ANCOVA|||||||0.471
72628663|NCT02949011|144785055|SUPERIORITY||LS Mean Difference|0.04|STANDARD_ERROR_OF_MEAN|0.06||0.4874|TWO_SIDED|95.0|-0.08|0.16||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|ANCOVA with baseline composite symptom score, preexisting and worsened symptom, region, and body temperature at baseline as covariates.||24 hours||0.16|-0.08|0.4874
72628664|NCT02949011|144785055|SUPERIORITY||LS Mean Difference|-0.36|STANDARD_ERROR_OF_MEAN|0.06|<|0.0001|TWO_SIDED|95.0|-0.47|-0.24||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|ANCOVA with baseline composite symptom score, preexisting and worsened symptom, region, and body temperature at baseline as covariates.||36 hours||-0.24|-0.47|<0.0001
72628665|NCT02949011|144785055|SUPERIORITY||LS Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.06||0.5414|TWO_SIDED|95.0|-0.15|0.08||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|ANCOVA with baseline composite symptom score, preexisting and worsened symptom, region, and body temperature at baseline as covariates.||36 hours||0.08|-0.15|0.5414
72410594|NCT00360334|144329538|SUPERIORITY_OR_OTHER|||||||0.601||95.0|||||ANCOVA|||||||0.601
72410595|NCT00360334|144329539|SUPERIORITY_OR_OTHER|||||||0.65||95.0|||||ANCOVA|||||||0.650
72410596|NCT00360334|144329540|SUPERIORITY_OR_OTHER|||||||0.017||95.0|||||ANCOVA|||||||0.017
72410597|NCT00360334|144329541|SUPERIORITY_OR_OTHER|||||||0.667||95.0|||||ANCOVA|||||||0.667
72410598|NCT00360334|144329542|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.675||||0.139||95.0|0.401|1.136|||Regression, Logistic|||Odds Ratio (OR) = odds of a patient in the exenatide arm achieving the secondary outcome divided by the odds of a patient in the insulin glargine arm achieving the secondary outcome||1.136|0.401|0.139
72410599|NCT00360334|144329543|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.317||||0.001||95.0|0.159|0.63|||Regression, Logistic|||Odds Ratio (OR) = odds of a patient in the exenatide arm achieving the secondary outcome divided by the odds of a patient in the insulin glargine arm achieving the secondary outcome||0.630|0.159|0.001
72542762|NCT03549130|144615698|SUPERIORITY||LS mean difference|-0.15||||0.4891|TWO_SIDED|95.0|-0.57|0.27||Between treatment p-values.|ANCOVA|Treatment,site used as factors;following variables as covariate:baseline, age,level of congestion symptoms at baseline,Berlin score,Epworth sleepiness|Difference between treatments of adjusted mean change from baseline.|Treatment comparison of Symptoms on Waking in the Morning in NRQLQ between active and placebo strip group for nasal congestion or stuffy nose.||0.27|-0.57|0.4891
72542763|NCT03549130|144615698|SUPERIORITY||LS mean difference|-0.01||||0.9498|TWO_SIDED|95.0|-0.43|0.4||Between treatment p-values.|ANCOVA|Treatment,site used as factors;following variables as covariate:baseline, age,level of congestion symptoms at baseline,Berlin score,Epworth sleepiness|Difference between treatments of adjusted mean change from baseline.|Treatment comparison of Symptoms on Waking in the Morning in NRQLQ between active and placebo strip group for congestion in sinuses.||0.40|-0.43|0.9498
72577338|NCT01701011|144681371|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Mixed Models Analysis|||IBM SPSS Statistics 20 was used to perform the statistical analysis. A mixed model for repeated measures was used to examine the differences between the three groups over time for the secondary outcome, depression. All models were estimated by the method of restricted maximum likelihood (REML) and the Compound Symmetry covariance structure was chosen for the repeated measures. The analysiswas performed according to the intention to treat.||||<0.05
72410600|NCT00360334|144329544|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.797||||0.716||95.0|0.235|2.705|||Regression, Logistic|||Odds Ratio (OR) = odds of a patient in the exenatide arm achieving the secondary outcome divided by the odds of a patient in the insulin glargine arm achieving the secondary outcome||2.705|0.235|0.716
72577339|NCT00976911|144681407|SUPERIORITY_OR_OTHER_LEGACY||Difference in Response Rates|15.7|||||TWO_SIDED|95.0|6.5|24.8||||||||24.8|6.5|
72577340|NCT00976911|144681407|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|TWO_SIDED||||||Pearson's chi-square|unstratified analysis||||||0.0010
72577341|NCT00976911|144681407|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0007|TWO_SIDED|||||Stratified analysis: The strata were chemotherapy selected (paclitaxel, PLD, or topotecan), prior anti-angiogenic therapy (yes or no), and platinum-free interval (\<3 or 3-6 months).|Cochran-Mantel-Haenszel|||||||0.0007
72577342|NCT00976911|144681408|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.45||||0.0202|TWO_SIDED|95.0|0.225|0.9||Unstratified analysis|Log Rank||Hazard ratio was estimated by unstratified Cox regression model.|||0.900|0.225|0.0202
72577343|NCT00976911|144681408|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0081|TWO_SIDED||||||Peto-Peto-Prentice|||||||0.0081
72577344|NCT00976911|144681410|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.379|||<|0.0001|TWO_SIDED|95.0|0.296|0.485|||Log Rank||Stratified analysis:Strata were chemotherapy selected (paclitaxel, PLD, or topotecan), prior anti-angiogenic therapy (yes or no), and platinum-free interval (less than \[\<\] 3 or 3-6 months). Cox regression model was used to determine the hazard ratio.|||0.485|0.296|<0.0001
72577345|NCT00976911|144681410|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.46|||<|0.0001|TWO_SIDED|95.0|0.366|0.577|||Log Rank|Unstratified analysis||||0.577|0.366|<0.0001
72577346|NCT00976911|144681410|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||Peto-Peto-Prentice|Unstratified analysis||||||<0.0001
72577347|NCT00976911|144681410|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||Peto-Peto-Prentice|Stratified analysis:Strata were chemotherapy selected, prior anti-angiogenic therapy, and platinum-free interval.||||||<0.0001
72577348|NCT00976911|144681411|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.833||||0.136|TWO_SIDED|95.0|0.655|1.059||Unstratified analysis|Log Rank|||||1.059|0.655|0.1360
72577349|NCT00976911|144681411|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0715|TWO_SIDED|||||Unstratified analysis|Peto-Peto-Prentice|||||||0.0715
72577350|NCT00976911|144681411|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.87||||0.2711|TWO_SIDED|95.0|0.678|1.116||Stratified analysis: The strata were chemotherapy selected (paclitaxel, PLD, or topotecan), prior anti-angiogenic therapy (yes or no), and platinum-free interval (\<3 or 3-6 months).|Log Rank|||||1.116|0.678|0.2711
72577351|NCT00976911|144681411|SUPERIORITY_OR_OTHER_LEGACY|||||||0.089|TWO_SIDED|||||Stratified analysis: The strata were chemotherapy selected (paclitaxel, PLD, or topotecan), prior anti-angiogenic therapy (yes or no), and platinum-free interval (\<3 or 3-6 months).|Peto-Peto-Prentice|||||||0.0890
72577352|NCT00976911|144681412|SUPERIORITY_OR_OTHER_LEGACY||Difference in Response Rates|8.8||||0.1859|TWO_SIDED|95.0|-3.8|21.4|||Fisher Exact||95% CI was approximated with Hauck-Anderson continuity correction.|Comparison of responders at baseline versus Week 8/9||21.4|-3.8|0.1859
72577353|NCT00976911|144681412|SUPERIORITY_OR_OTHER_LEGACY||Difference in Response Rates|3.5||||0.8309|TWO_SIDED|95.0|-14.0|20.9|||Fisher Exact||95% CI was approximated with Hauck-Anderson continuity correction.|Comparison of responders at baseline versus at Week 16/18||20.9|-14|0.8309
72577354|NCT00976911|144681412|SUPERIORITY_OR_OTHER_LEGACY||Difference in Response Rates|9.3||||0.579|TWO_SIDED|95.0|-15.0|34.1|||Fisher Exact||95% CI was approximated with Hauck-Anderson continuity correction.|Comparison of responders at baseline versus at Week 24||34.1|-15|0.5790
72628666|NCT02949011|144785055|SUPERIORITY||LS Mean Difference|-0.33|STANDARD_ERROR_OF_MEAN|0.06|<|0.0001|TWO_SIDED|95.0|-0.44|-0.22||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|ANCOVA with baseline composite symptom score, preexisting and worsened symptom, region, and body temperature at baseline as covariates.||48 hours||-0.22|-0.44|<0.0001
72628667|NCT02949011|144785055|SUPERIORITY||LS Mean Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.06||0.3185|TWO_SIDED|95.0|-0.17|0.05||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|ANCOVA with baseline composite symptom score, preexisting and worsened symptom, region, and body temperature at baseline as covariates.||48 hours||0.05|-0.17|0.3185
72628668|NCT02949011|144785055|SUPERIORITY||LS Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.05||0.0025|TWO_SIDED|95.0|-0.26|-0.06||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|ANCOVA with baseline composite symptom score, preexisting and worsened symptom, region, and body temperature at baseline as covariates.||72 hours||-0.06|-0.26|0.0025
72628669|NCT02949011|144785055|SUPERIORITY||LS Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.05||0.8299|TWO_SIDED|95.0|-0.09|0.11||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|ANCOVA with baseline composite symptom score, preexisting and worsened symptom, region, and body temperature at baseline as covariates.||72 hours||0.11|-0.09|0.8299
72628670|NCT02949011|144785055|SUPERIORITY||LS Mean Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.05||0.0878|TWO_SIDED|95.0|-0.19|0.01||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|ANCOVA with baseline composite symptom score, preexisting and worsened symptom, region, and body temperature at baseline as covariates.||96 hours||0.01|-0.19|0.0878
72628671|NCT02949011|144785055|SUPERIORITY||LS Mean Difference|0.02|STANDARD_ERROR_OF_MEAN|0.05||0.7498|TWO_SIDED|95.0|-0.09|0.12||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|ANCOVA with baseline composite symptom score, preexisting and worsened symptom, region, and body temperature at baseline as covariates.||96 hours||0.12|-0.09|0.7498
72410601|NCT00360334|144329545|SUPERIORITY_OR_OTHER|||||||0.113||95.0|||||ANCOVA on ranks|||||||0.113
72628672|NCT02949011|144785055|SUPERIORITY||LS Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.05||0.803|TWO_SIDED|95.0|-0.11|0.09||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|ANCOVA with baseline composite symptom score, preexisting and worsened symptom, region, and body temperature at baseline as covariates.||120 hours||0.09|-0.11|0.8030
72542764|NCT03549130|144615698|SUPERIORITY||LS mean difference|-0.36||||0.1235|TWO_SIDED|95.0|-0.83|0.1||Between treatment p-values.|ANCOVA|Treatment,site used as factors;following variables as covariate:baseline, age,level of congestion symptoms at baseline,Berlin score,Epworth sleepiness|Difference between treatments of adjusted mean change from baseline.|Treatment comparison of Symptoms on Waking in the Morning in NRQLQ between active and placebo strip group for time to clear nighttime drainage after waking up.||0.10|-0.83|0.1235
72542765|NCT03549130|144615699|SUPERIORITY|||||||0.8498||||||P-value are based on chi-square test|Chi-squared|||Treatment comparison of participants showing improvement based on NRQLQ on all of the items in sleep problems.||||0.8498
72542766|NCT03549130|144615699|SUPERIORITY|||||||0.4652||||||P-value are based on chi-square test|Chi-squared|||Treatment comparison of participants showing improvement based on NRQLQ on any of the items in sleep problems.||||0.4652
72542767|NCT03549130|144615699|SUPERIORITY|||||||0.439||||||P-value are based on chi-square test|Chi-squared|||Treatment comparison of participants showing improvement based on NRQLQ on all of the items in sleep time problems.||||0.4390
72542768|NCT03549130|144615699|SUPERIORITY|||||||0.2997||||||P-value are based on chi-square test|Chi-squared|||Treatment comparison of participants showing improvement based on NRQLQ on any of the items in sleep time problems.||||0.2997
72628673|NCT02949011|144785055|SUPERIORITY||LS Mean Difference|0.05|STANDARD_ERROR_OF_MEAN|0.05||0.3577|TWO_SIDED|95.0|-0.05|0.15||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|ANCOVA with baseline composite symptom score, preexisting and worsened symptom, region, and body temperature at baseline as covariates.||120 hours||0.15|-0.05|0.3577
72628674|NCT02949011|144785056|SUPERIORITY||Median Difference|-23.1||||0.0009||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Peto-Prentice's generalized Wilcoxon test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Cough||||0.0009
72628675|NCT02949011|144785056|SUPERIORITY||Median Difference|-0.2||||0.4074||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Peto-Prentice's generalized Wilcoxon test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Cough||||0.4074
72628676|NCT02949011|144785056|SUPERIORITY||Median Difference|-6.3||||0.2496||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Peto-Prentice's generalized Wilcoxon test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Sore Throat||||0.2496
72628677|NCT02949011|144785056|SUPERIORITY||Median Difference|0.9||||0.2963||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Peto-Prentice's generalized Wilcoxon test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Sore Throat||||0.2963
72410602|NCT00360334|144329546|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA on ranks|||||||<0.001
72542769|NCT03549130|144615699|SUPERIORITY|||||||0.1116||||||P-value are based on chi-square test|Chi-squared|||Treatment comparison of participants showing improvement based on NRQLQ on all of the items in symptoms on waking in AM.||||0.1116
72410603|NCT00360334|144329547|SUPERIORITY_OR_OTHER|||||||0.74||95.0|||||ANCOVA on ranks|||||||0.740
72542770|NCT03549130|144615699|SUPERIORITY|||||||0.5101||||||P-value are based on chi-square test|Chi-squared|||Treatment comparison of participants showing improvement based on NRQLQ on any of the items in symptoms on waking in AM.||||0.5101
72542771|NCT03549130|144615699|SUPERIORITY|||||||0.474||||||P-value are based on chi-square test|Chi-squared|||Treatment comparison of participants showing improvement based on NRQLQ on all of the items in practical problems.||||0.4740
72542772|NCT03549130|144615699|SUPERIORITY|||||||0.2787||||||P-value are based on chi-square test|Chi-squared|||Treatment comparison of participants showing improvement based on NRQLQ on any of the items in practical problems.||||0.2787
72542773|NCT03549130|144615700|SUPERIORITY|||||||0.5958||||||P-value are based on chi-square test|Chi-squared|||Treatment comparison of participants showing improvement based on NRQLQ on all of the items in sleep problems.||||0.5958
72542774|NCT03549130|144615700|SUPERIORITY|||||||0.7296||||||P-value are based on chi-square test|Chi-squared|||Treatment comparison of participants showing improvement based on NRQLQ on any of the items in sleep problems.||||0.7296
72542775|NCT03549130|144615700|SUPERIORITY|||||||0.7171||||||P-value are based on chi-square test|Chi-squared|||Treatment comparison of participants showing improvement based on NRQLQ on all of the items in sleep time problems.||||0.7171
72542776|NCT03549130|144615700|SUPERIORITY|||||||0.403||||||P-value are based on chi-square test|Chi-squared|||Treatment comparison of participants showing improvement based on NRQLQ on any of the items in sleep time problems.||||0.4030
72542777|NCT03549130|144615700|SUPERIORITY|||||||0.4741||||||P-value are based on chi-square test|Chi-squared|||Treatment comparison of participants showing improvement based on NRQLQ on all of the items in symptoms on waking in AM.||||0.4741
72542778|NCT03549130|144615700|SUPERIORITY|||||||0.5591||||||P-value are based on chi-square test|Chi-squared|||Treatment comparison of participants showing improvement based on NRQLQ on any of the items in symptoms on waking in AM.||||0.5591
72542779|NCT03549130|144615700|SUPERIORITY|||||||0.8285||||||P-value are based on chi-square test|Chi-squared|||Treatment comparison of participants showing improvement based on NRQLQ on all of the items in practical problems.||||0.8285
72542780|NCT03549130|144615700|SUPERIORITY|||||||0.3487||||||P-value are based on chi-square test|Chi-squared|||Treatment comparison of participants showing improvement based on NRQLQ on any of the items in practical problems.||||0.3487
72542781|NCT04356573|144615708|SUPERIORITY|||||||0.05|||||||t-test, 2 sided|||||||0.05
72542782|NCT01577537|144615711|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
72542783|NCT00950833|144615718|NON_INFERIORITY|The immune memory would be demonstrated if the lower limit (LL) of the 95% confidence interval (CI) around the geometric mean concentration (GMC) ratios (Pooled Synflorix I+II Group over Synflorix III Group) was higher than 1 for pneumococcal serotype 1.|GMC ratio for anti-1|6.17|||||TWO_SIDED|95.0|5.03|7.58|||ANOVA|||To demonstrate the immunological memory induced for anti-pneumococcal serotype 1 following primary vaccination in study 107017 (NCT00370318) and booster vaccination in study 107137 (NCT00496015) with the Synflorix™ vaccine, through evaluation of early antibody responses after an additional dose of Synflorix™ vaccine at 40-48 months of age, compared to the Synflorix III Group.||7.58|5.03|
72577355|NCT00976911|144681412|SUPERIORITY_OR_OTHER_LEGACY||Difference in Response Rates|-4.8||||0.7339|TWO_SIDED|95.0|-40.0|30.6|||Fisher Exact||95% CI was approximated with Hauck-Anderson continuity correction.|Comparison of responders at baseline versus at Week 30||30.6|-40|0.7339
72577356|NCT01266031|144681425|SUPERIORITY_OR_OTHER|||||||0.26||||||Null hypothesis is: PFS 6 months of Bevacizumab = PFS 6 months of Bevacizumab + Vorinostat.|Chi-squared|||Null hypothesis is: progression free survival (PFS) 6 months of Bevacizumab = PFS 6 months of Bevacizumab + Vorinostat.||||0.26
72577357|NCT00447876|144681471|SUPERIORITY_OR_OTHER_LEGACY||Treatment difference|0.2|||=|0.182|TWO_SIDED|95.0|-0.06|0.46|||Fisher Exact|||The responders rate at Week 6 was compared between treatment groups by a two-sided Fisher exact test.||0.46|-0.06|=0.182
72628678|NCT02949011|144785056|SUPERIORITY||Median Difference|-10.6||||0.039||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Peto-Prentice's generalized Wilcoxon test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Headache||||0.0390
72542784|NCT00950833|144615718|NON_INFERIORITY|The immune memory would be demonstrated if the lower limit (LL) of the 95% confidence interval (CI) around the geometric mean concentration (GMC) ratios (Pooled SynflorixI+II Group over Synflorix Group) was higher than 1 for pneumococcal serotype 4.|GMC ratio for anti-4|2.86|||||TWO_SIDED|95.0|2.38|3.45|||ANOVA|||To demonstrate the immunological memory for anti-pneumococcal serotype 4 induced following primary vaccination in study 107017 (NCT00370318) and booster vaccination in study 107137 (NCT00496015) with the Synflorix™ vaccine, through evaluation of early antibody responses after an additional dose of Synflorix™ vaccine at 40-48 months of age, compared to the Synflorix III Group.||3.45|2.38|
72542785|NCT00950833|144615718|NON_INFERIORITY|The immune memory would be demonstrated if the lower limit (LL) of the 95% confidence interval (CI) around the geometric mean concentration (GMC) ratios (Pooled Synflorix I+II Group over Synflorix III Group) was higher than 1 for pneumococcal serotype 5.|GMC ratio for anti-5|13.47|||||TWO_SIDED|95.0|10.96|16.55|||ANOVA|||To demonstrate the immunological memory for anti-pneumococcal serotype 5 induced following primary vaccination in study 107017 (NCT00370318) and booster vaccination in study 107137 (NCT00496015) with the Synflorix™ vaccine, through evaluation of early antibody responses after an additional dose of Synflorix™ vaccine at 40-48 months of age, compared to the Synflorix III Group.||16.55|10.96|
72542786|NCT00950833|144615718|NON_INFERIORITY|The immune memory would be demonstrated if the lower limit (LL) of the 95% confidence interval (CI) around the geometric mean concentration (GMC) ratios (Pooled Synflorix I+II Group over Synflorix III Group) was higher than 1 for pneumococcal serotype 6B.|GMC ratio for anti-6B|28.81|||||TWO_SIDED|95.0|22.54|36.81|||ANOVA|||To demonstrate the immunological memory for anti-pneumococcal serotype 6B induced following primary vaccination in study 107017 (NCT00370318) and booster vaccination in study 107137 (NCT00496015) with the Synflorix™ vaccine, through evaluation of early antibody responses after an additional dose of Synflorix™ vaccine at 40-48 months of age, compared to the Synflorix III Group.||36.81|22.54|
72577358|NCT00447876|144681472|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.222|||||||Cochran-Mantel-Haenszel|||Gerbershagen's Global scores were compared at Week 18 using a Cochran-Mantel-Haenszel analysis of variance statistic with adjustment to the baseline score.||||=0.222
72577359|NCT00447876|144681474|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-8.837|||=|0.423|TWO_SIDED|95.0|-30.94|13.266|||ANCOVA|||SPID was compared between the two treatment groups using a fixed effect analysis of covariance (ANCOVA) taking into account the SPID value as dependent variable, the baseline pain intensity as co-variable, and the treatment group as explicative variable.||13.266|-30.940|=0.423
72577360|NCT00447876|144681476|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-4.173|||=|0.682|TWO_SIDED|95.0|-24.64|16.294|||ANCOVA|||SPID was compared between the two treatment groups using a fixed effect ANCOVA taking into account the SPID value as dependent variable, the baseline pain intensity as co-variable, and the treatment group as explicative variable.||16.294|-24.640|=0.682
72577361|NCT00447876|144681478|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-8.066|||=|0.438|TWO_SIDED|95.0|-28.91|12.779|||ANCOVA|||The sum of pain threshold difference (i.e. SPID expressed as AUC) was compared between the two treatment groups using a fixed effect ANCOVA taking into account the SPID AUC value as dependent variable, the baseline pain intensity as co-variable, and the treatment group as explicative variable.||12.779|-28.910|=0.438
72577362|NCT00447876|144681480|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.594|||=|0.937|TWO_SIDED|95.0|-14.575|15.762|||ANCOVA|||The sum of pressure threshold difference (i.e. SPID expressed as AUC) was compared between the two treatment groups using a fixed effect ANCOVA taking into account the SPID AUC value as dependent variable, the baseline pain intensity as co-variable, and the treatment group as explicative variable.||15.762|-14.575|=0.937
72577363|NCT00447876|144681481|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.8|||=|0.8|TWO_SIDED|95.0|-6.8|5.3||The difference (most affected side - control side) in ROM for the dorsal extension was analyzed using a fixed effect ANCOVA, using Week 18 results as the dependent variable and baseline value as covariate.|ANCOVA|||||5.3|-6.8|=0.800
72577364|NCT00447876|144681482|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.862|||||||Wilcoxon rank sum test|||Dysport® vs placebo at Week 2. The variables for global assessment of pain assessed by the Investigator were described at each visit as ordinal qualitative variables and were compared between the two treatment groups by means of a non parametric Wilcoxon rank sum test.||||=0.862
72577365|NCT00447876|144681482|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.317|||||||Wilcoxon rank sum test|||Dysport® vs placebo at Week 6. The variables for global assessment of pain assessed by the Investigator were described at each visit as ordinal qualitative variables and were compared between the two treatment groups by means of a non parametric Wilcoxon rank sum test.||||=0.317
72577366|NCT00447876|144681482|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.525|||||||Wilcoxon rank sum test|||Dysport® vs placebo at Week 10. The variables for global assessment of pain assessed by the Investigator were described at each visit as ordinal qualitative variables and were compared between the two treatment groups by means of a non parametric Wilcoxon rank sum test.||||=0.525
72577367|NCT00447876|144681482|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.931|||||||Wilcoxon rank sum test|||Dysport® vs placebo at Week 14. The variables for global assessment of pain assessed by the Investigator were described at each visit as ordinal qualitative variables and were compared between the two treatment groups by means of a non parametric Wilcoxon rank sum test.||||=0.931
72577368|NCT00447876|144681482|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.353|||||||Wilcoxon rank sum test|||Dysport® vs placebo at Week 18. The variables for global assessment of pain assessed by the Investigator were described at each visit as ordinal qualitative variables and were compared between the two treatment groups by means of a non parametric Wilcoxon rank sum test.||||=0.353
72577369|NCT00447876|144681483|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.882|||||||Wilcoxon rank sum test|||Dysport® vs placebo at Week 2. The variables for global assessment of pain assessed by the patient were described at each visit as ordinal qualitative variables and were compared between the two treatment groups by means of a non parametric Wilcoxon rank sum test.||||=0.882
72577370|NCT00447876|144681483|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.489|||||||Wilcoxon rank sum test|||Dysport® vs placebo at Week 6. The variables for global assessment of pain assessed by the patient were described at each visit as ordinal qualitative variables and were compared between the two treatment groups by means of a non parametric Wilcoxon rank sum test.||||=0.489
72577371|NCT00447876|144681483|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.66|||||||Wilcoxon rank sum test|||Dysport® vs placebo at Week 10. The variables for global assessment of pain assessed by the patient were described at each visit as ordinal qualitative variables and were compared between the two treatment groups by means of a non parametric Wilcoxon rank sum test.||||=0.660
72577372|NCT00447876|144681483|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.485|||||||Wilcoxon rank sum test|||Dysport® vs placebo at Week 14. The variables for global assessment of pain assessed by the patient were described at each visit as ordinal qualitative variables and were compared between the two treatment groups by means of a non parametric Wilcoxon rank sum test.||||=0.485
72577373|NCT00447876|144681483|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.392|||||||Wilcoxon rank sum test|||Dysport® vs placebo at Week 18. The variables for global assessment of pain assessed by the patient were described at each visit as ordinal qualitative variables and were compared between the two treatment groups by means of a non parametric Wilcoxon rank sum test.||||=0.392
72577374|NCT01256944|144681484|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
72410604|NCT03837496|144329565|SUPERIORITY||Slope|-0.66||||0.504|TWO_SIDED|95.0|-2.59|1.27||a priori threshold p\<0.05|ANCOVA|Adjusted for distress and receipt of ovarian suppression.||Analysis comparing the change in monthly adherence to adjuvant endocrine therapy across the study period adjusting for distress and receipt of ovarian suppression.||1.27|-2.59|.504
72410605|NCT03837496|144329565|SUPERIORITY||Slope|-0.17||||0.225|TWO_SIDED|95.0|-0.44|-0.1||a priori threshold p\<0.05|ANCOVA|Adjusted for distress and receipt of ovarian suppression||Analysis comparing the change in weekly adherence rates to adjuvant endocrine therapy across the study period adjusting for distress and receipt of ovarian suppression.||-0.10|-0.44|.225
72410606|NCT03837496|144329566|SUPERIORITY||Mean Difference (Final Values)|0.13||||0.63|TWO_SIDED|95.0|-0.4|0.66||a priori threshold p \< 0.05|ANCOVA|Adjusted for baseline values of criterion outcomes, distress and receipt of ovarian suppression||Analysis comparing the change in self-reported endocrine therapy adherence between groups on the MARS-5 scale from baseline to 12-weeks post-baseline adjusting for distress, receipt of ovarian suppression, and baseline values of criterion outcome.||0.66|-0.40|.630
72410607|NCT03837496|144329567|SUPERIORITY||Mean Difference (Final Values)|2.58||||0.186|TWO_SIDED|95.0|-1.27|6.44||a priori threshold p \< 0.05|ANCOVA|Adjusted for baseline values of criterion outcomes, distress and receipt of ovarian suppression||Analysis comparing the change in satisfaction with adjuvant endocrine therapy between groups on the CTSQ from baseline to 12 weeks post-baseline adjusting for distress, receipt of ovarian suppression, and baseline values of criterion outcome.||6.44|-1.27|.186
72410608|NCT03837496|144329568|SUPERIORITY||Mean Difference (Final Values)|-0.79||||0.562|TWO_SIDED|95.0|-3.49|1.91||a priori threshold p \< 0.05|ANCOVA|Adjusted for baseline values of criterion outcomes, distress and receipt of ovarian suppression||Analysis comparing the change in symptom distress between groups on the BCPT scale from baseline to 12-weeks post-baseline adjusting for distress, receipt of ovarian suppression, and baseline values of criterion outcome.||1.91|-3.49|.562
72410609|NCT01208233|144329601|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.735||||0.4962|TWO_SIDED|80.0|0.41|1.31|||Regression, Logistic|LOCF was used to impute missing data.||||1.31|0.41|0.4962
72410610|NCT01208233|144329601|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.561||||0.2517|TWO_SIDED|80.0|0.29|1.07|||Regression, Logistic|The analysis was based on OC.||||1.07|0.29|0.2517
72410611|NCT01208233|144329602|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.141|STANDARD_ERROR_OF_MEAN|3.942||0.9716|TWO_SIDED|80.0|-4.972|5.254|||Mixed Models Analysis|||Paretic hand||5.254|-4.972|0.9716
72410612|NCT01208233|144329603|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.789|STANDARD_ERROR_OF_MEAN|7.2392||0.1417|TWO_SIDED|80.0|1.401|20.177|||Mixed Models Analysis|||Paretic to non-paretic hand ratio (%)||20.177|1.401|0.1417
72410613|NCT01208233|144329604|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.33|STANDARD_ERROR_OF_MEAN|5.4241||0.0611|TWO_SIDED|80.0|-17.351|-3.31|||Mixed Models Analysis|||Paretic hand||-3.310|-17.351|0.0611
72410614|NCT01208233|144329604|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.235|STANDARD_ERROR_OF_MEAN|3.2899||0.9433|TWO_SIDED|80.0|-4.011|4.48|||Mixed Models Analysis|||Non-paretic hand||4.480|-4.011|0.9433
72410615|NCT01208233|144329605|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.812|STANDARD_ERROR_OF_MEAN|6.8448||0.0654|TWO_SIDED|80.0|-21.668|-3.957|||Mixed Models Analysis|||Paretic to non-paretic hand ratio (%)||-3.957|-21.668|0.0654
72410616|NCT01208233|144329606|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.972||||0.951|TWO_SIDED|80.0|0.54|1.76|||Regression, Logistic|||LOCF was used to impute missing data.||1.76|0.54|0.9510
72410617|NCT01208233|144329607|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.854||||0.7234|TWO_SIDED|80.0|0.48|1.51|||Regression, Logistic|||LOCF was used to impute missing data.||1.51|0.48|0.7234
72410618|NCT01208233|144329608|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.283|STANDARD_ERROR_OF_MEAN|0.6755||0.6759|TWO_SIDED|80.0|-1.156|0.589|||Mixed Models Analysis|||||0.589|-1.156|0.6759
72410619|NCT01208233|144329609|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.433||||0.4213|TWO_SIDED|80.0|0.81|2.54|||Regression, Logistic|||BI \>=95, LOCF was used to impute missing data.||2.54|0.81|0.4213
72410620|NCT01208233|144329609|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.651||||0.276|TWO_SIDED|80.0|0.92|2.98|||Regression, Logistic|||BI=100, LOCF was used to impute missing data.||2.98|0.92|0.2760
72410621|NCT01208233|144329610|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.599|STANDARD_ERROR_OF_MEAN|4.4547||0.2118|TWO_SIDED|80.0|-0.15|11.348|||Mixed Models Analysis|||||11.348|-0.150|0.2118
72410622|NCT01208233|144329611|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.062|STANDARD_ERROR_OF_MEAN|1.7844||0.5541|TWO_SIDED|80.0|-1.252|3.375|||Mixed Models Analysis|||||3.375|-1.252|0.5541
72410623|NCT01208233|144329612|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.334|STANDARD_ERROR_OF_MEAN|0.4178||0.426|TWO_SIDED|80.0|-0.874|0.205|||Mixed Models Analysis|||||0.205|-0.874|0.4260
72410624|NCT01208233|144329613|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.477|STANDARD_ERROR_OF_MEAN|5.4394||0.65|TWO_SIDED|80.0|-4.547|9.5|||Mixed Models Analysis|||(L+R)/28 × 100%||9.500|-4.547|0.6500
72410625|NCT01208233|144329613|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.874|STANDARD_ERROR_OF_MEAN|6.7431||0.5671|TWO_SIDED|80.0|-4.834|12.583|||Mixed Models Analysis|||(L/14) × 100%||12.583|-4.834|0.5671
72410626|NCT01208233|144329613|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.049|STANDARD_ERROR_OF_MEAN|5.2816||0.843|TWO_SIDED|80.0|-5.771|7.87|||Mixed Models Analysis|||(R/14) × 100%||7.870|-5.771|0.8430
72410627|NCT01208233|144329614|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.106|STANDARD_ERROR_OF_MEAN|0.0733||0.1512|TWO_SIDED|80.0|0.011|0.201|||Mixed Models Analysis|||(L R)/(L+R)||0.201|0.011|0.1512
72410628|NCT01208233|144329615|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.279|STANDARD_ERROR_OF_MEAN|0.5041||0.0128|TWO_SIDED|80.0|-1.929|-0.629|||Mixed Models Analysis|||||-0.629|-1.929|0.0128
72410629|NCT01208233|144329616|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.089|STANDARD_ERROR_OF_MEAN|0.1226||0.4713|TWO_SIDED|80.0|-0.07|0.248|||Mixed Models Analysis|||||0.248|-0.070|0.4713
72410630|NCT01208233|144329623|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.516|STANDARD_ERROR_OF_MEAN|2.7201||0.8501|TWO_SIDED|80.0|-4.026|2.995|||Mixed Models Analysis|||Non-paretic hand||2.995|-4.026|0.8501
72577375|NCT01256944|144681485|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
72577376|NCT01256944|144681486|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
72577377|NCT01256944|144681488|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
72577378|NCT01256944|144681489|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
72577379|NCT01256944|144681490|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
72410631|NCT01181895|144329624|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.07||||0.244|TWO_SIDED|95.0|-0.048|0.188||P-value for the adjusted treatment difference for Vilanterol 25 µg OD versus Placebo.|ANCOVA||The estimated value represents the adjusted treatment difference in the weighted mean 0-24 hour FEV1 (Liters) at Week 12 for Vilanterol 25 µg OD versus Placebo.|||0.188|-0.048|0.244
72410632|NCT01181895|144329624|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.006||||0.926|TWO_SIDED|95.0|-0.124|0.113||P-value for the adjusted treatment difference for Salmetarol 50 µg BID versus Placebo.|ANCOVA||The estimated value represents the adjusted treatment difference in the weighted mean 0-24 hour FEV1 (Liters) at Week 12 for Salmeterol 50 µg BID versus Placebo.|||0.113|-0.124|0.926
72542787|NCT00950833|144615718|NON_INFERIORITY|The immune memory would be demonstrated if the lower limit (LL) of the 95% confidence interval (CI) around the geometric mean concentration (GMC) ratios (Pooled Synflorix I+II Group over Synflorix III Group) was higher than 1 for pneumococcal serotype 7F.|GMC ratio for anti-7F|4.75|||||TWO_SIDED|95.0|3.9|5.78|||ANOVA|||To demonstrate the immunological memory for anti-pneumococcal serotype 7F induced following primary vaccination in study 107017 (NCT00370318) and booster vaccination in study 107137 (NCT00496015) with the Synflorix™ vaccine, through evaluation of early antibody responses after an additional dose of Synflorix™ vaccine at 40-48 months of age, compared to the Synflorix III Group.||5.78|3.9|
72542788|NCT00950833|144615718|NON_INFERIORITY|The immune memory would be demonstrated if the lower limit (LL) of the 95% confidence interval (CI) around the geometric mean concentration (GMC) ratios (Pooled Synflorix I+II Group over Synflorix III Group) was higher than 1 for pneumococcal serotype 9V.|GMC ratio for anti-9V|14.1|||||TWO_SIDED|95.0|11.21|17.75|||ANOVA|||To demonstrate the immunological memory for anti-pneumococcal serotype 9V induced following primary vaccination in study 107017 (NCT00370318) and booster vaccination in study 107137 (NCT00496015) with the Synflorix™ vaccine, through evaluation of early antibody responses after an additional dose of Synflorix™ vaccine at 40-48 months of age, compared to the Synflorix III Group.||17.75|11.21|
72542789|NCT00950833|144615718|NON_INFERIORITY|The immune memory would be demonstrated if the lower limit (LL) of the 95% confidence interval (CI) around the geometric mean concentration (GMC) ratios (Pooled Synflorix I+II Group over Synflorix III Group) was higher than 1 for pneumococcal serotype 14.|GMC ratio for anti-14|22.92|||||TWO_SIDED|95.0|17.51|30.0|||ANOVA|||To demonstrate the immunological memory for anti-pneumococcal serotype 14 induced following primary vaccination in study 107017 (NCT00370318) and booster vaccination in study 107137 (NCT00496015) with the Synflorix™ vaccine, through evaluation of early antibody responses after an additional dose of Synflorix™ vaccine at 40-48 months of age, compared to the Synflorix III Group.||30|17.51|
72542790|NCT00950833|144615718|NON_INFERIORITY|The immune memory would be demonstrated if the lower limit (LL) of the 95% confidence interval (CI) around the geometric mean concentration (GMC) ratios (Pooled Synflorix I+II Group over Synflorix III Group) was higher than 1 for pneumococcal serotype 18C.|GMC ratio for anti-18C|10.01|||||TWO_SIDED|95.0|7.95|12.61|||ANOVA|||To demonstrate the immunological memory for anti-pneumococcal serotype 18C induced following primary vaccination in study 107017 (NCT00370318) and booster vaccination in study 107137 (NCT00496015) with the Synflorix™ vaccine, through evaluation of early antibody responses after an additional dose of Synflorix™ vaccine at 40-48 months of age, compared to the Synflorix III Group.||12.61|7.95|
72542791|NCT00950833|144615718|NON_INFERIORITY|The immune memory would be demonstrated if the lower limit (LL) of the 95% confidence interval (CI) around the geometric mean concentration (GMC) ratios (Pooled Synflorix I+II Group over Synflorix III Group) was higher than 1 for pneumococcal serotype 19F.|GMC ratio for anti-19F|9.25|||||TWO_SIDED|95.0|7.29|11.74|||ANOVA|||To demonstrate the immunological memory for anti-pneumococcal serotype 19F induced following primary vaccination in study 107017 (NCT00370318) and booster vaccination in study 107137 (NCT00496015) with the Synflorix™ vaccine, through evaluation of early antibody responses after an additional dose of Synflorix™ vaccine at 40-48 months of age, compared to the Synflorix III Group.||11.74|7.29|
72542792|NCT00950833|144615718|NON_INFERIORITY|The immune memory would be demonstrated if the lower limit (LL) of the 95% confidence interval (CI) around the geometric mean concentration (GMC) ratios (Pooled Synflorix I+II Group over Synflorix III Group) was higher than 1 for pneumococcal serotype 23F.|GMC ratio for anti-23F|36.52|||||TWO_SIDED|95.0|27.59|48.34|||ANOVA|||To demonstrate the immunological memory for anti-pneumococcal serotype 23F induced following primary vaccination in study 107017 (NCT00370318) and booster vaccination in study 107137 (NCT00496015) with the Synflorix™ vaccine, through evaluation of early antibody responses after an additional dose of Synflorix™ vaccine at 40-48 months of age, compared to the Synflorix III Group.||48.34|27.59|
72542793|NCT04132232|144615745|SUPERIORITY|||||||0.06|||||||Chi-squared|||||||0.06
72542794|NCT00368537|144615746|NON_INFERIORITY_OR_EQUIVALENCE|A 2-sided 95% CI (corrected for continuity) was calculated for the true difference between the cure rates. Non-inferiority will be concluded if the lower limit of the 2-sided CI is greater than -15%.|Risk Difference (RD)|0.0||||||95.0|-8.7|8.6|||||Confidence interval calculated using asymptotic method corrected for continuity. Difference= Tigecycline minus Ampicillin-Sulbactam or Amoxicillin-Clavulanate.|||8.6|-8.7|
72542795|NCT00368537|144615747|NON_INFERIORITY_OR_EQUIVALENCE|A 2-sided 95% CI (corrected for continuity) was calculated for the true difference between the cure rates. Non-inferiority will be concluded if the lower limit of the 2-sided CI is greater than -15%.|Risk Difference (RD)|2.2||||||95.0|-9.6|14.0|||||Confidence interval calculated using asymptotic method corrected for continuity. Difference= Tigecycline minus Ampicillin-Sulbactam or Amoxicillin-Clavulanate.|||14.0|-9.6|
72542796|NCT00368537|144615748|NON_INFERIORITY_OR_EQUIVALENCE|A 2-sided 95% CI (corrected for continuity) was calculated for the true difference between the cure rates. Non-inferiority will be concluded if the lower limit of the 2-sided CI is greater than -15%.|Risk Difference (RD)|2.4||||||95.0|-9.6|14.4|||||Confidence interval calculated using asymptotic method corrected for continuity. Difference= Tigecycline minus Ampicillin-Sulbactam or Amoxicillin-Clavulanate.|Group comparison of eradication + presumed eradication||14.4|-9.6|
72577380|NCT01256944|144681491|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
72577381|NCT01256944|144681493|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
72577382|NCT01256944|144681494|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
72410633|NCT01891734|144329634|SUPERIORITY_OR_OTHER||Cohen's d|0.3|||<|0.05|TWO_SIDED|95.0|||||Mixed Models Analysis|||||||<0.05
72410634|NCT01891734|144329635|SUPERIORITY_OR_OTHER||Cohen's d|0.3|||<|0.05|TWO_SIDED|95.0|||||Mixed Models Analysis|||||||<0.05
72628679|NCT02949011|144785056|SUPERIORITY||Median Difference|2.0||||0.7877||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Peto-Prentice's generalized Wilcoxon test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Headache||||0.7877
72628680|NCT02949011|144785056|SUPERIORITY||Median Difference|-12.1||||0.0017||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Peto-Prentice's generalized Wilcoxon test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Nasal Congestion||||0.0017
72628681|NCT02949011|144785056|SUPERIORITY||Median Difference|1.5||||0.8119||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Peto-Prentice's generalized Wilcoxon test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Nasal Congestion||||0.8119
72628682|NCT02949011|144785056|SUPERIORITY||Median Difference|-3.6||||0.007||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Peto-Prentice's generalized Wilcoxon test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Feverishness or Chills||||0.0070
72628683|NCT02949011|144785056|SUPERIORITY||Median Difference|-0.7||||0.9191||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Peto-Prentice's generalized Wilcoxon test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Feverishness or Chills||||0.9191
72628684|NCT02949011|144785056|SUPERIORITY||Median Difference|-7.7||||0.0232||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Peto-Prentice's generalized Wilcoxon test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Muscle or Joint Pain||||0.0232
72628685|NCT02949011|144785056|SUPERIORITY||Median Difference|4.0||||0.5436||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Peto-Prentice's generalized Wilcoxon test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Muscle or Joint Pain||||0.5436
72628686|NCT02949011|144785056|SUPERIORITY||Median Difference|-7.5||||0.0207||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Peto-Prentice's generalized Wilcoxon test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Fatigue||||0.0207
72628687|NCT02949011|144785056|SUPERIORITY||Median Difference|-1.9||||0.371||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Peto-Prentice's generalized Wilcoxon test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Fatigue||||0.3710
72410635|NCT04028388|144329639|SUPERIORITY||Hazard Ratio (HR)|1.22||||0.1465|TWO_SIDED|95.0|0.56|2.65|||Wilcoxon (Mann-Whitney)|||||2.65|0.56|0.1465
72542797|NCT00368537|144615750|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-1.2||||0.444||95.0|-4.4|2.0|||Fisher Exact|2-sided||Intensive care unit||2.0|-4.4|0.444
72542798|NCT01368276|144615755|SUPERIORITY_OR_OTHER||Treatment Difference|-42.9||||0.2645|TWO_SIDED|||||Descriptive|Fisher Exact||Talimogene laherparepvec - GM-CSF|||||0.2645
72410636|NCT04028388|144329643|SUPERIORITY||Hazard Ratio (HR)|1.76||||0.4576|TWO_SIDED|95.0|0.39|7.93|||Log Rank|||DOR is calculated in the subpopulation of subjects experiencing a response (CR or PR). Hazard Ratio \< 1 means that tested drug (ModraDoc006/r) has better outcome.||7.93|0.39|0.4576
72628688|NCT02949011|144785057|SUPERIORITY||Median Difference|-23.4||||0.4634||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Peto-Prentice's generalized Wilcoxon test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||||||0.4634
72628689|NCT02949011|144785057|SUPERIORITY||Median Difference|-0.6||||0.6386||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Peto-Prentice's generalized Wilcoxon test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||||||0.6386
72628690|NCT02949011|144785058|SUPERIORITY|||||||0.0112||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Fisher Exact|||||||0.0112
72628691|NCT02949011|144785058|SUPERIORITY|||||||0.8478||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Fisher Exact|||||||0.8478
72628692|NCT02949011|144785059|SUPERIORITY||||||<|0.0001||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Fisher Exact|||Any Complications||||<0.0001
72628693|NCT02949011|144785059|SUPERIORITY|||||||0.2558||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Fisher Exact|||Any Complications||||0.2558
72628694|NCT00163189|144785061|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Student's paired t-test|||Month 36||||<0.001
72628695|NCT00163189|144785062|SUPERIORITY_OR_OTHER_LEGACY|||||||0.008|||||||Student's paired t-test|||Month 36||||0.008
72628696|NCT02941614|144785118|OTHER|Conducted test of null hypothesis of no difference vs any, between intervention and control sites at three different time periods (6- vs. 3-months, 12- vs. 6-months, 12- vs. 3-months), as well as omnibus test of treatment-by-time interaction.|see above|-0.21||||0.92|TWO_SIDED|95.0|-4.48|4.05|||Mixed Models Analysis|We used a difference-in-differences model to estimate the time, treatment, and time-by-treatment effects.||Data below is for FACT-B 3 month Total Score||4.05|-4.48|0.92
72542799|NCT01368276|144615756|SUPERIORITY_OR_OTHER||Treatment Difference|-1.2||||1|TWO_SIDED|95.0|-57.3|54.9||Descriptive|Fisher Exact||Talimogene laherparepvec - GM-CSF|||54.9|-57.3|1.0000
72542800|NCT00711867|144615770|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin was defined as -0.5 C.|Mean Difference (Final Values)|-0.34||||||95.0|-0.55|-0.14|||t-test, 2 sided|||H0: Mu\_VH - Mu\_BH \<= -0.5 C.||-0.14|-0.55|
72628697|NCT02941614|144785118|OTHER|Conducted test of null hypothesis of no difference vs any, between intervention and control sites at three different time periods (6- vs. 3-months, 12- vs. 6-months, 12- vs. 3-months), as well as omnibus test of treatment-by-time interaction.|see above|1.37||||0.57|TWO_SIDED|95.0|-3.41|6.15|||Mixed Models Analysis|We used a difference-in-differences model to estimate the time, treatment, and time-by-treatment effects.||The data below is for FACT-B 6 month Total Score||6.15|-3.41|0.57
72628698|NCT02941614|144785118|OTHER|Conducted test of null hypothesis of no difference vs any, between intervention and control sites at three different time periods (6- vs. 3-months, 12- vs. 6-months, 12- vs. 3-months), as well as omnibus test of treatment-by-time interaction|see above|1.18||||0.62|TWO_SIDED|95.0|-3.54|5.89|||Mixed Models Analysis|We used a difference-in-differences model to estimate the time, treatment, and time-by-treatment effects||The data below is for the Fact-B 12 month Total Score||5.89|-3.54|0.62
72628699|NCT02941614|144785118|OTHER|Conducted test of null hypothesis of no difference vs any, between intervention and control sites at three different time periods (6- vs. 3-months, 12- vs. 6-months, 12- vs. 3-months), as well as omnibus test of treatment-by-time interaction.|see above|0.12||||0.83|TWO_SIDED|95.0|-0.99|1.23|||Mixed Models Analysis|We used a difference-in-differences model to estimate the time, treatment, and time-by-treatment effects.||The data below is for the Fact-B 3 month Physical Well-Being Subscale||1.23|-0.99|0.83
72628700|NCT02941614|144785118|OTHER|Conducted test of null hypothesis of no difference vs any, between intervention and control sites at three different time periods (6- vs. 3-months, 12- vs. 6-months, 12- vs. 3-months), as well as omnibus test of treatment-by-time interaction|see above|0.15||||0.82|TWO_SIDED|95.0|-1.15|1.45|||Mixed Models Analysis|We used a difference-in-differences model to estimate the time, treatment, and time-by-treatment effects.||Data below is for the Fact-B 6 month Physical Well-Being Subscale||1.45|-1.15|0.82
72628701|NCT02941614|144785118|OTHER|Conducted test of null hypothesis of no difference vs any, between intervention and control sites at three different time periods (6- vs. 3-months, 12- vs. 6-months, 12- vs. 3-months), as well as omnibus test of treatment-by-time interaction|see above|-0.13||||0.84|TWO_SIDED|95.0|-1.41|1.15|||Mixed Models Analysis|We used a difference-in-differences model to estimate the time, treatment, and time-by-treatment effects.||Data below is for the Fact-B 12 month Physical Well-Being Subscale||1.15|-1.41|0.84
72628702|NCT02941614|144785118|OTHER|Conducted test of null hypothesis of no difference vs any, between intervention and control sites at three different time periods (6- vs. 3-months, 12- vs. 6-months, 12- vs. 3-months), as well as omnibus test of treatment-by-time interaction|see above|-0.17||||0.77|TWO_SIDED|95.0|-1.31|0.96|||Mixed Models Analysis|We used a difference-in-differences model to estimate the time, treatment, and time-by-treatment effects.||The data below is for the Fact-B 3 month Social/Family Well-Being Subscale||0.96|-1.31|0.77
72628703|NCT02941614|144785118|OTHER|Conducted test of null hypothesis of no difference vs any, between intervention and control sites at three different time periods (6- vs. 3-months, 12- vs. 6-months, 12- vs. 3-months), as well as omnibus test of treatment-by-time interaction|see above|-0.56||||0.42|TWO_SIDED|95.0|-1.91|0.79|||Mixed Models Analysis|We used a difference-in-differences model to estimate the time, treatment, and time-by-treatment effects.||The data below is for the Fact-B 6 month Social/Family Well-Being Subscale||0.79|-1.91|0.42
72628704|NCT02941614|144785118|OTHER|Conducted test of null hypothesis of no difference vs any, between intervention and control sites at three different time periods (6- vs. 3-months, 12- vs. 6-months, 12- vs. 3-months), as well as omnibus test of treatment-by-time interaction|see above|-0.08||||0.9|TWO_SIDED|95.0|-1.41|1.24|||Mixed Models Analysis|We used a difference-in-differences model to estimate the time, treatment, and time-by-treatment effects.||The data below is for the Fact-B 12 month Social/Family Well-Being Subscale||1.24|-1.41|0.90
72628705|NCT02941614|144785118|OTHER|Conducted test of null hypothesis of no difference vs any, between intervention and control sites at three different time periods (6- vs. 3-months, 12- vs. 6-months, 12- vs. 3-months), as well as omnibus test of treatment-by-time interaction|see above|0.05||||0.9|TWO_SIDED|95.0|-0.76|0.87|||Mixed Models Analysis|We used a difference-in-differences model to estimate the time, treatment, and time-by-treatment effects.||The data below is for the Fact-B 3 month Emotional Well-Being Subscale||0.87|-0.76|0.90
72628706|NCT02941614|144785118|OTHER|Conducted test of null hypothesis of no difference vs any, between intervention and control sites at three different time periods (6- vs. 3-months, 12- vs. 6-months, 12- vs. 3-months), as well as omnibus test of treatment-by-time interaction|see above|0.58||||0.25|TWO_SIDED|95.0|-0.4|1.56|||Mixed Models Analysis|We used a difference-in-differences model to estimate the time, treatment, and time-by-treatment effects.||The data below is for the Fact B 6 month Emotional Well-Being Subscale||1.56|-0.40|0.25
72628707|NCT02941614|144785118|OTHER|Conducted test of null hypothesis of no difference vs any, between intervention and control sites at three different time periods (6- vs. 3-months, 12- vs. 6-months, 12- vs. 3-months), as well as omnibus test of treatment-by-time interaction|see above|0.6||||0.22|TWO_SIDED|95.0|-0.36|1.57|||Mixed Models Analysis|We used a difference-in-differences model to estimate the time, treatment, and time-by-treatment effects.||The data below is for the Fact-B 12 month Emotional Well-Being Subscale||1.57|-0.36|0.22
72628708|NCT02941614|144785118|OTHER|Conducted test of null hypothesis of no difference vs any, between intervention and control sites at three different time periods (6- vs. 3-months, 12- vs. 6-months, 12- vs. 3-months), as well as omnibus test of treatment-by-time interaction|see above|0.14||||0.81|TWO_SIDED|95.0|-1.05|1.34|||Mixed Models Analysis|We used a difference-in-differences model to estimate the time, treatment, and time-by-treatment effects.||The data below is for Fact-B 3 month Functional Well-Being Subscale||1.34|-1.05|0.81
72410637|NCT04028388|144329644|SUPERIORITY||Hazard Ratio (HR)|1.5||||0.0776|TWO_SIDED|95.0|0.65|3.48|||Wilcoxon (Mann-Whitney)|||"Difference between the cohorts is tested with Log-rank test and estimated using Univariate Cox model.~Wilcoxon test is used if proportional hazards assumption is not fulfilled. Hazard Ratio \< 1 means that tested drug (ModraDoc006/r) has better outcome"||3.48|0.65|0.0776
72628709|NCT02941614|144785118|OTHER|Conducted test of null hypothesis of no difference vs any, between intervention and control sites at three different time periods (6- vs. 3-months, 12- vs. 6-months, 12- vs. 3-months), as well as omnibus test of treatment-by-time interaction|see above|0.54||||0.45|TWO_SIDED|95.0|-0.85|1.94|||Mixed Models Analysis|We used a difference-in-differences model to estimate the time, treatment, and time-by-treatment effects.||The data below is for Fact-B 6 month Functional Well-Being Subscale||1.94|-0.85|0.45
72329437|NCT03037476|144184380|OTHER|General Linear Model|Slope|-0.149||||0.164|TWO_SIDED|95.0|-0.36|0.061|||Mixed Models Analysis|Negative Binomial Regression||Changes from Baseline to 12 Month Follow-up reported in this section.||.061|-.360|0.164
72542801|NCT04133519|144615771|SUPERIORITY||Odds Ratio (OR)|1.16||||0.5352|TWO_SIDED|95.0|0.73|1.84||P value from Cochran-Mantel-Haenszel testing of H0: OR=1; H1: OR≠1 adjusting for IBS subtype and gender|Cochran-Mantel-Haenszel|||P value from Cochran-Mantel-Haenszel testing of H0: OR=1; H1: OR≠1 adjusting for IBS subtype and gender||1.84|0.73|0.5352
72542802|NCT04133519|144615771|SUPERIORITY||Odds Ratio (OR)|1.76||||0.0232|TWO_SIDED|95.0|1.08|2.87|||Cochran-Mantel-Haenszel||Odds ratio reflects the odds of the number of GDH responders being greater than the number of MR responders for abdominal pain intensity.|The final 4 weeks of the on-treatment period (weeks 9-12) was a pre-specified period for analysis of the primary endpoint measure of abdominal pain due to IBS. An abdominal pain intensity responder was defined as a participant whose daily abdominal pain intensity averaged over the last 4 weeks of phase s (weeks 9 through 12) was at least 30% reduced compared with the daily abdominal pain intensity averaged over the 4 weeks of phase 1.||2.87|1.08|0.0232
72542803|NCT04133519|144615771|SUPERIORITY||Odds Ratio (OR)|1.76||||0.0254|TWO_SIDED|95.0|1.07|2.89||P-value from Cochran-Mantel-Haenszel Test testing H0: OR=1; H1: OR\<\>1 adjusting for IBS subtype and gender|Cochran-Mantel-Haenszel||Odds ratio reflects the odds of GDH being superior to MR.|"Abdominal pain scores were averaged each week on treatment (1-12) and compared with the average baseline abdominal pain score. Participants that recorded a \> 30% decrease in abdominal pain in at least half the weeks on treatment were considered responders.~This analysis was specified in FDA Guidance for Industry, Irritable Bowel Syndrome - Clinical Evaluation of Drugs for Treatment, May 2012. Both the analysis period and the responder threshold (30%) are specified by the FDA Guidance."|Among all subjects, 64.0% reported Adequate Relief and 67.7% reported overall satisfaction with Regulora.|2.89|1.07|0.0254
72542804|NCT04133519|144615772|SUPERIORITY||Mean Difference (Final Values)|0.6||||0.8115|TWO_SIDED|95.0|-0.434|0.554|||ANOVA|||The least square (LS) mean difference between the GDH and MR groups using an analysis of variance (ANOVA) model||0.554|-0.434|0.8115
72542805|NCT04133519|144615773|SUPERIORITY||Mean Difference (Final Values)|0.044||||0.7564|TWO_SIDED|95.0|-0.236|0.325|||ANOVA|||Average abdominal pain frequency at Week 13-16 will be statistically compared between GDH and comparator using an ANOVA model adjusted for gender and IBS subtype. The daily pain frequency measurement was derived from the daily pain intensity measurement. Days where severity was \>0 were considered a day with pain and were recorded as positive. Days with a score of 0 were days without pain. Mean represents the mean number of days in each time period with abdominal pain.||0.325|-0.236|0.7564
72542806|NCT04133519|144615774|SUPERIORITY||Odds Ratio (OR)|1.17||||0.4753|TWO_SIDED|95.0|0.76|1.81||P-value from Cochran-Mantel-Haenszel Test testing H0: OR=1; H1: OR\<\>1 adjusting for IBS subtype and gender|Cochran-Mantel-Haenszel||GDH:MR Relative Risk|A Stool Consistency Responder is defined as a \>=30% improvement in the proportion of Bristol Stool Form Scale (BSFS) scores that fall within Group 2 (normal stools)||1.81|0.76|0.4753
72577383|NCT00005957|144681495|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.91||||0.38|TWO_SIDED|95.0|0.72|1.13|||Log Rank||Hazard ratio (HR) estimation is for Standard Breast Irradiation arm versus Breast Radiation plus regional radiation arm.|It was estimated that the actuarial five year survival of patients on the control arm of this trial would be 80% and a 5% increase in five year survival with experiment arm is clinically interesting to detect. A sample size of 1832 will ensure 80% power to detect such a difference with two-sided alpha of 0.05.||1.13|0.72|0.38
72577384|NCT00005957|144681496|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.76||||0.01|TWO_SIDED|95.0|0.61|0.94|||Log Rank|||||0.94|0.61|0.01
72577385|NCT02047734|144681504|SUPERIORITY||Rate Ratio|0.623|||<|0.0001|TWO_SIDED|95.0|0.506|0.768||To account for multiple comparisons, each of the 2 treatment comparisons was tested at the alpha = 0.025 level.|Poisson regression model|Adjusted for region, age, and Baseline number of GdE lesions, and Included the natural log transformation of time on study as an offset term.|Rate Ratio = Ozanimod / IFN β-1a|||0.768|0.506|<0.0001
72577386|NCT02047734|144681504|SUPERIORITY||Rate Ratio|0.791||||0.0167|TWO_SIDED|95.0|0.652|0.958||To account for multiple comparisons, each of the 2 treatment comparisons was tested at the alpha = 0.025 level.|Poisson Regression Model|Adjusted for region, age, and Baseline number of GdE lesions, and Included the natural log transformation of time on study as an offset term.|Rate Ratio = Ozanimod / IFN β-1a|||0.958|0.652|0.0167
72577387|NCT02047734|144681505|SUPERIORITY||Rate Ratio|0.576|||<|0.0001|TWO_SIDED|95.0|0.465|0.714||To control for type 1 error, the key secondary endpoints were tested in order in a sequential, closed hierarchical testing procedure. Each comparison was tested at the alpha = 0.05 level.|Negative Binomial Regression Model|Adjusted for region, age, and Baseline GdE lesions, and included the natural log transformation of available number of MRI scans as an offset term.|Rate Ratio = Ozanimod / IFN β-1a|||0.714|0.465|<0.0001
72577388|NCT02047734|144681505|SUPERIORITY||Rate Ratio|0.657||||0.0001|TWO_SIDED|95.0|0.531|0.813||To control for type 1 error, the key secondary endpoints were tested in order in a sequential, closed hierarchical testing procedure. Each comparison was tested at the alpha = 0.05 level.|Negative binomial regression model|Adjusted for region, age, and Baseline GdE lesions and included the natural log transformation of available number of MRI scans as an offset term.|Rate Ratio = Ozanimod / IFN β-1a|||0.813|0.531|0.0001
72542807|NCT04133519|144615775|SUPERIORITY||Mean Difference (Final Values)|0.08||||0.6793|TWO_SIDED|95.0|-0.301|0.46|||Mixed Models Analysis|||"The analysis is based on the mixed model repeated measures (MMRM) analysis of variance model for IBS-C participants:~parameter = treatment + timepoint + treatment\*timepoint + gender + subject error + random Means are the mean daily number of bowel movements for a 24-hour period."||0.460|-0.301|0.6793
72542808|NCT04133519|144615775|SUPERIORITY||Mean Difference (Final Values)|0.173||||0.9468|TWO_SIDED|95.0|-4.904|5.249|||Mixed Models Analysis|||"The analysis is based on the mixed model repeated measures (MMRM) analysis of variance model for IBS-D participants:~parameter = treatment + timepoint + treatment\*timepoint + gender + subject error + random Means are the mean daily number of bowel movements for a 24-hour period."||5.249|-4.904|0.9468
72542809|NCT04133519|144615776|SUPERIORITY||Median Difference (Final Values)|-1.602||||0.5015|TWO_SIDED|95.0|-6.282|3.077|||Mixed Models Analysis|||"The analysis is based on the mixed model repeated measures (MMRM) analysis of variance model:~parameter = treatment + timepoint + treatment\*timepoint + gender + subject error + random The unstructured covariance matrix was used to model the within-participant correlation. The model-based least square (LS) means and LS mean differences (GDH minus comparator) and associated 95% CIs for each week and overall were estimated."||3.077|-6.282|0.5015
72542810|NCT04133519|144615777|SUPERIORITY||Mean Difference (Final Values)|4.586||||0.2117|TWO_SIDED|95.0|-2.619|11.79|||Mixed Models Analysis|||"Percent Overall Work Impairment Due to IBS defined as the percent time missed by not showing up for work, plus the percent time missed while working, and calculated as: Q2/(Q2+Q4)+\[(1-(Q2/(Q2+Q4))x(Q5/10)\]."||11.790|-2.619|0.2117
72542811|NCT04133519|144615778|SUPERIORITY||Mean Difference (Net)|2.372||||0.3676|TWO_SIDED|95.0|-2.793|7.537|||Mixed Models Analysis|||The analysis is based on the mixed model repeated measures (MMRM) analysis of variance model: parameter = treatment + timepoint + treatment\*timepoint + gender + subject error + random||7.537|-2.793|0.3676
72542812|NCT00475852|144615791|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.7||||0.313|TWO_SIDED|95.0|-2.1|0.7|||Cochran-Mantel-Haenszel|Stratified by geographical region.||||0.7|-2.1|0.313
72542813|NCT00475852|144615792|SUPERIORITY_OR_OTHER|||||||0.03|||||||Van Elteren test|Controlled for region.||||||0.030
72542814|NCT00475852|144615793|SUPERIORITY_OR_OTHER|||||||0.007|||||||Van Elteren test|Controlled for region.||||||0.007
72542815|NCT00475852|144615794|SUPERIORITY_OR_OTHER|||||||0.318|||||||Van Elteren test|Controlled for region.||||||0.318
72542816|NCT00475852|144615795|SUPERIORITY_OR_OTHER|||||||0.018|||||||Van Elteren test|Controlled for region.||||||0.018
72542817|NCT00475852|144615796|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.5||||0.295|TWO_SIDED|95.0|-1.5|0.5|||Cochran-Mantel-Haenszel|Controlled for region.||||0.5|-1.5|0.295
72542818|NCT00475852|144615797|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.2|STANDARD_ERROR_OF_MEAN|0.17||0.16|||||||ANOVA|Controlled for region.|This analysis excluded subjects who were lost to follow-up, or withdrawal of consent before Day 30, or whose Day 30 visit occurred prior to Day 30.|||||0.160
72542819|NCT00475852|144615798|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.9||||0.238|TWO_SIDED|95.0|-2.4|0.6|||Cochran-Mantel-Haenszel|Controlled for region.|For subjects with a Day 30 visit prior to Day 30, information from their Day 180 visit, if available, was used to impute the mortality and rehospitalization status at Day 30.|||0.6|-2.4|0.238
72542820|NCT00475852|144615802|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.09||||0.109|TWO_SIDED|95.0|0.98|1.21|||Cochran-Mantel-Haenszel|Controlled for region.||||1.21|0.98|0.109
72577389|NCT02047734|144681506|SUPERIORITY||Rate Ratio|0.471||||0.0006|TWO_SIDED|95.0|0.306|0.725||To control for type 1 error, the key secondary endpoints were tested in order in a sequential, closed hierarchical testing procedure. Each comparison was tested at the alpha = 0.05 level.|Negative Binomial Regression Model|Adjusted for region, age, and Baseline GdE lesions with the natural log transformation of available MRI scans at Month 24 as an offset term.|Rate ratio = Ozanimod / IFN β-1a|||0.725|0.306|0.0006
72577390|NCT02047734|144681506|SUPERIORITY||Rate Ratio|0.528||||0.003|TWO_SIDED|95.0|0.346|0.805||To control for type 1 error, the key secondary endpoints were tested in order in a sequential, closed hierarchical testing procedure. Each comparison was tested at the alpha = 0.05 level.|Negative binomial regression model,|Adjusted for region, age, and Baseline GdE lesions with the natural log transformation of available MRI scans at Month 24 as an offset term.|Rate ratio = Ozanimod / IFN β-1a|||0.805|0.346|0.0030
72329438|NCT03037476|144184381|OTHER|General Linear Model|Slope|-0.24||||0.603|TWO_SIDED|95.0|-1.12|0.65|||Mixed Models Analysis|Poisson Regression||Change in Medical Misuse of Prescription Stimulant Medication Among those with ADHD Diagnosis from Baseline to 6 Month Followup||.650|-1.120|.603
72542821|NCT02273206|144615818|SUPERIORITY|||||||0.2562|||||||Chi-squared|p\<0.05||Colorectal Cancer Screening Intervention Arm Difference||||0.2562
72542822|NCT02273206|144615818|SUPERIORITY|||||||0.9795|||||||Chi-squared|p\<0.05||Breast Cancer Screening Intervention Arm Difference||||0.9795
72542823|NCT02273206|144615818|SUPERIORITY|||||||0.3917|||||||Chi-squared|p\<0.05||Cervical Cancer Screening Intervention Arm Difference||||0.3917
72542824|NCT02273206|144615819|SUPERIORITY|Test the coefficient for intervention|Odds Ratio (OR)|1.346||||0.0677|TWO_SIDED|95.0|0.979|1.851||Treatment Group (CCI vs PCM)|Regression, Logistic|p\<0.05|In the logistic regression model, adjustments were made for PHQ9 at baseline, improvement of depression by one level, baseline colorectal cancer up to date status, age, and income.|||1.851|0.979|0.0677
72542825|NCT02273206|144615820|SUPERIORITY|Test the coefficient for intervention|Odds Ratio (OR)|1.031||||0.8501|TWO_SIDED|95.0|0.753|1.41||Treatment Group (CCI vs PCM)|Regression, Logistic|p\<0.05|In the logistic regression model, adjustments were made for PHQ9 at baseline, improvement of depression by one level, baseline breast cancer up to date status, age, and income|||1.410|0.753|0.8501
72542826|NCT02273206|144615821|SUPERIORITY|Test the coefficient for intervention|Odds Ratio (OR)|0.876||||0.4432|TWO_SIDED|95.0|0.625|1.228||Treatment Group(CCI vs PCM)|Regression, Logistic|p\<0.05|In the logistic regression model, adjustments were made for PHQ9 at baseline, improvement of depression by one level, baseline cervical cancer up to date status, age, and income.|||1.228|0.625|0.4432
72542827|NCT02273206|144615822|SUPERIORITY|||||||0.39|||||||Two-sample t-test|p\<0.05||PHQ9 Intervention Arm Difference between baseline and 12-month follow up||||0.39
72542828|NCT02273206|144615823|SUPERIORITY|||||||0.6|||||||Chi-squared|||The Hopkins Symptom Checklist (SCL-20) at baseline.||||0.60
72542829|NCT02273206|144615823|SUPERIORITY|||||||0.86|||||||Chi-squared|||The Hopkins Symptom Checklist (SCL-20) at 6 Months||||0.86
72410638|NCT04028388|144329646|SUPERIORITY||Hazard Ratio (HR)|1.4||||0.2539|TWO_SIDED|95.0|0.79|2.49|||Log Rank|||"Difference between the cohorts is tested with Log-rank test and estimated using Univariate Cox model.~Wilcoxon test is used if proportional hazards assumption is not fulfilled. Hazard Ratio \< 1 means that tested drug (ModraDoc006/r) has better outcome."||2.49|0.79|0.2539
72410639|NCT04028388|144329647|SUPERIORITY||Hazard Ratio (HR)|1.35||||0.3062|TWO_SIDED|95.0|0.76|2.42|||Wilcoxon (Mann-Whitney)|||"Difference between the cohorts is tested with Log-rank test and estimated using Univariate Cox model.~Wilcoxon test is used if proportional hazards assumption is not fulfilled. Hazard Ratio \< 1 means that tested drug (ModraDoc006/r) has better outcome."||2.42|0.76|0.3062
72542830|NCT02273206|144615824|SUPERIORITY|||||||0.6|||||||Chi-squared|||The Hopkins Symptom Checklist (SCL-20) at Baseline.||||0.60
72542831|NCT02273206|144615824|SUPERIORITY|||||||0.23|||||||Chi-squared|||The Hopkins Symptom Checklist (SCL-20) at 12 months.||||0.23
72628710|NCT02941614|144785118|OTHER|Conducted test of null hypothesis of no difference vs any, between intervention and control sites at three different time periods (6- vs. 3-months, 12- vs. 6-months, 12- vs. 3-months), as well as omnibus test of treatment-by-time interaction|see above|-0.11||||0.87|TWO_SIDED|95.0|-1.48|1.26|||Mixed Models Analysis|We used a difference-in-differences model to estimate the time, treatment, and time-by-treatment effects.||The data below is for the Fact-B 12 month Functional Well-Being Subscale||1.26|-1.48|0.87
72410640|NCT01114516|144329666|SUPERIORITY_OR_OTHER|||||||0.018|TWO_SIDED||||||Log Rank|||Kaplan Meier survival analysis||||0.018
72410641|NCT01114516|144329667|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.48|||||TWO_SIDED|95.0|1.06|2.05||||||||2.05|1.06|
72410642|NCT01114516|144329668|SUPERIORITY_OR_OTHER|||||||0.393|TWO_SIDED||||||Kruskal-Wallis|||||||0.393
72410643|NCT01431508|144329671|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05||95.0|||||t-test, 2 sided|||Comparison of Week 12 and Baseline||||<0.05
72542832|NCT02273206|144615825|SUPERIORITY|||||||0.4483|||||||Chi-squared|p\<0.05||Colorectal Cancer Screening Intervention Arm Difference at 12 Months||||0.4483
72542833|NCT02273206|144615825|SUPERIORITY|||||||0.1706|||||||Chi-squared|p\<0.05||Cervical Cancer Screening Intervention Arm Difference at 12 Months||||0.1706
72542834|NCT02273206|144615825|SUPERIORITY|||||||0.3568|||||||Chi-squared|p\<0.05||Breast Cancer Screening Intervention Arm Difference at 12 Months||||0.3568
72542835|NCT02273206|144615826|SUPERIORITY|||||||0.85|||||||Chi-squared|||Mental Health Care Utilization - Mental Health Visits at baseline.||||0.85
72542836|NCT02273206|144615826|SUPERIORITY|||||||0.23|||||||Chi-squared|||Mental Health Care Utilization - Mental Health Visits at 6 months.||||0.23
72577391|NCT02047734|144681507|SUPERIORITY||Hazard Ratio (HR)|1.045||||0.8224|TWO_SIDED|95.0|0.711|1.537||To control for type 1 error, the key secondary endpoints were tested in order in a sequential, closed hierarchical testing procedure. Each comparison was tested at the alpha = 0.05 level.|Cox proportional hazards model|Adjusted for region (Eastern Europe vs Rest of World) age at Baseline, and Baseline EDSS score|Hazard ratio (Ozanimod / IFN β-1a) based on Cox proportional hazard model with factors for treatment group, adjusted for region, age at Baseline, and Baseline EDSS score.|||1.537|0.711|0.8224
72577392|NCT02047734|144681507|SUPERIORITY||Hazard Ratio (HR)|0.798||||0.2849|TWO_SIDED|95.0|0.528|1.206||To control for type 1 error, the key secondary endpoints were tested in order in a sequential, closed hierarchical testing procedure. Each comparison was tested at the alpha = 0.05 level.|Cox proportional hazards model|Adjusted for region (Eastern Europe vs Rest of World), age at Baseline, and Baseline EDSS score|Hazard ratio (Ozanimod / IFN β-1a) based on Cox proportional hazard model with factors for treatment group, adjusted for region, age at Baseline, and Baseline EDSS score.|||1.206|0.528|0.2849
72577393|NCT02047734|144681508|SUPERIORITY||Hazard Ratio (HR)|1.435||||0.1353|TWO_SIDED|95.0|0.893|2.305||To control for type 1 error, the key secondary endpoints were tested in order in a sequential, closed hierarchical testing procedure. Each comparison was tested at the alpha = 0.05 level.|Cox proportional hazard model|Adjusted for region (Eastern Europe vs Rest of World), age at Baseline, and Baseline EDSS score|Hazard ratio (Ozanimod / IFN β-1a) based on Cox proportional hazard model with factors for treatment group, adjusted for region, age at Baseline, and Baseline EDSS score.|||2.305|0.893|0.1353
72577394|NCT02047734|144681508|SUPERIORITY||Hazard Ratio (HR)|1.098||||0.7154|TWO_SIDED|95.0|0.664|1.815||To control for type 1 error, the key secondary endpoints were tested in order in a sequential, closed hierarchical testing procedure. Each comparison was tested at the alpha = 0.05 level.|Cox proportional hazard model|Adjusted for region (Eastern Europe vs Rest of World), age at Baseline, and Baseline EDSS score|Hazard ratio (Ozanimod / IFN β-1a) based on Cox proportional hazard model with factors for treatment group, adjusted for region, age at Baseline, and Baseline EDSS score.|||1.815|0.664|0.7154
72577395|NCT02047734|144681509|SUPERIORITY||Difference|9.4||||0.0047|TWO_SIDED|95.0|2.9|15.8|||Cochran-Mantel-Haenszel|Stratified by region (Eastern Europe vs Rest of the World) and Baseline EDSS category||||15.8|2.9|0.0047
72577396|NCT02047734|144681509|SUPERIORITY||Difference|7.1||||0.032|TWO_SIDED|95.0|0.6|13.6|||Cochran-Mantel-Haenszel|Stratified by region (Eastern Europe vs Rest of the World) and Baseline EDSS category||||13.6|0.6|0.0320
72577397|NCT02047734|144681510|SUPERIORITY||Difference|5.4||||0.0466|TWO_SIDED|95.0|0.0|10.8|||Cochran-Mantel-Haenszel|Based on the Cochran-Mantel-Haenszel test stratified by region (Eastern Europe vs. rest of the world) and Baseline EDSS category||||10.8|0.0|0.0466
72577398|NCT02047734|144681510|SUPERIORITY||Difference|5.1||||0.0581|TWO_SIDED|95.0|-0.3|10.5|||Cochran-Mantel-Haenszel|Based on the Cochran-Mantel-Haenszel test stratified by region (Eastern Europe vs. rest of the world) and Baseline EDSS category||||10.5|-0.3|0.0581
72577399|NCT02047734|144681511|SUPERIORITY||Difference in means|0.244|||<|0.0001|TWO_SIDED|95.0|0.125|0.363||Based on the analysis of covariance model, adjusted for region (Eastern Europe vs. rest of the world), Baseline EDSS category, and brain volume at Baseline|ANCOVA||Difference in means based on the analysis of covariance model, adjusted for region (Eastern Europe vs. rest of the world), Baseline EDSS category, and brain volume at Baseline.|||0.363|0.125|<0.0001
72577400|NCT02047734|144681511|SUPERIORITY||Difference in means|0.224||||0.0002|TWO_SIDED|95.0|0.106|0.342||Based on the analysis of covariance model, adjusted for region (Eastern Europe vs. rest of the world), Baseline EDSS category, and brain volume at Baseline.|ANCOVA||Difference in means based on the analysis of covariance model, adjusted for region (Eastern Europe vs. rest of the world), Baseline EDSS category, and brain volume at Baseline.|||0.342|0.106|0.0002
72410644|NCT00129259|144329674|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||ANCOVA|P-value for testing treatment effect uses change in ln(AUC+1) as the outcome variable and adjusts for baseline ln(AUC+1).||"Null hypothesis: The mean change from baseline to Month 24 in the 4-hour C-peptide AUC does not differ between treatment groups after adjusting for baseline C-peptide AUC.~Alternative hypothesis: The mean change from baseline to Month 24 in the 4-hour C-peptide AUC differs between the treatment groups after adjusting for baseline values."||||0.002
72410645|NCT00129259|144329675|SUPERIORITY_OR_OTHER|||||||0.697||95.0|||||ANCOVA|ANCOVA adjusts for baseline HbA1c.||"Null hypothesis: The mean change in HbA1c from baseline (pre-treatment) to Month 24 does not differ between treatment groups.~Alternative hypothesis: The mean change in HbA1c from baseline to Month 24 differs between treatment groups."||||0.697
72628711|NCT02941614|144785118|OTHER|Conducted test of null hypothesis of no difference vs any, between intervention and control sites at three different time periods (6- vs. 3-months, 12- vs. 6-months, 12- vs. 3-months), as well as omnibus test of treatment-by-time interaction|see above|0.16||||0.8|TWO_SIDED|95.0|-1.13|1.45|||Mixed Models Analysis|We used a difference-in-differences model to estimate the time, treatment, and time-by-treatment effects.||The data below is for the Fact-B 3 month Breast Cancer Subscale||1.45|-1.13|0.80
72542837|NCT02273206|144615826|SUPERIORITY|||||||0.98|||||||Chi-squared|||Mental Health Care Utilization - Mental Health Visits at 12 months.||||0.98
72542838|NCT02273206|144615826|SUPERIORITY|||||||0.57|||||||Chi-squared|||Mental Health Care Utilization - Mental Health Prescriptions at baseline.||||0.57
72542839|NCT02273206|144615826|SUPERIORITY|||||||0.92|||||||Chi-squared|||Mental Health Care Utilization - Mental Health Prescriptions at 6 months.||||0.92
72542840|NCT02273206|144615826|SUPERIORITY|||||||0.99|||||||Chi-squared|||Mental Health Care Utilization - Mental Health Prescriptions at 12 months.||||0.99
72542841|NCT02273206|144615827|SUPERIORITY|||||||0.2|||||||Chi-squared|||Satisfaction with decision to participate in colorectal cancer screening at baseline.||||0.20
72542842|NCT02273206|144615827|SUPERIORITY|||||||0.17|||||||Chi-squared|||Satisfaction with decision to participate in colorectal cancer screening at 6 months.||||0.17
72542843|NCT02273206|144615827|SUPERIORITY|||||||0.69|||||||Chi-squared|||Satisfaction with decision to participate in colorectal cancer screening at 12 months.||||0.69
72542844|NCT02273206|144615827|SUPERIORITY|||||||0.72|||||||Chi-squared|||Satisfaction with decision to participate in breast cancer screening at baseline.||||0.72
72542845|NCT02273206|144615827|SUPERIORITY|||||||0.72|||||||Chi-squared|||Satisfaction with decision to participate in breast cancer screening at 6 months.||||0.72
72542846|NCT02273206|144615827|SUPERIORITY|||||||0.87|||||||Chi-squared|||Satisfaction with decision to participate in breast cancer screening at 12 months.||||0.87
72542847|NCT02273206|144615827|SUPERIORITY|||||||0.65|||||||Chi-squared|||Satisfaction with decision to participate in cervical cancer screening at baseline.||||0.65
72542848|NCT02273206|144615827|SUPERIORITY|||||||0.82|||||||Chi-squared|||Satisfaction with decision to participate in cervical cancer screening at 6 months.||||0.82
72542849|NCT02273206|144615827|SUPERIORITY|||||||0.92|||||||Chi-squared|||Satisfaction with decision to participate in cervical cancer screening at 12 months.||||0.92
72542850|NCT02273206|144615827|SUPERIORITY|||||||0.56|||||||Chi-squared|||Satisfaction with decision to participate in Mental Health Care at 12 months.||||0.56
72542851|NCT02273206|144615828|SUPERIORITY|||||||0.17|||||||Chi-squared|||Physician Recommendation of Colorectal Cancer Screening at baseline.||||0.17
72542852|NCT02273206|144615828|SUPERIORITY|||||||0.38|||||||Chi-squared|||Physician Recommendation of Colorectal Cancer Screening at 6 months.||||0.38
72542853|NCT02273206|144615828|SUPERIORITY|||||||0.07|||||||Chi-squared|||Physician Recommendation of Colorectal Cancer Screening at 12 months.||||0.07
72542854|NCT02273206|144615828|SUPERIORITY|||||||0.99|||||||Chi-squared|||Physician Recommendation of Breast Cancer Screening at baseline.||||0.99
72542855|NCT02273206|144615828|SUPERIORITY|||||||0.15|||||||Chi-squared|||Physician Recommendation of Breast Cancer Screening at 6 months.||||0.15
72542856|NCT02273206|144615828|SUPERIORITY|||||||0.55|||||||Chi-squared|||Physician Recommendation of Breast Cancer Screening at 12 months.||||0.55
72542857|NCT02273206|144615828|SUPERIORITY|||||||0.34|||||||Chi-squared|||Physician Recommendation of Cervical Cancer Screening at baseline.||||0.34
72542858|NCT02273206|144615828|SUPERIORITY|||||||0.31|||||||Chi-squared|||Physician Recommendation of Cervical Cancer Screening at 6 months. .||||0.31
72542859|NCT02273206|144615828|SUPERIORITY|||||||0.39|||||||Chi-squared|||Physician Recommendation of Cervical Cancer Screening at 12 months.||||0.39
72542860|NCT02273206|144615828|SUPERIORITY|||||||0.87|||||||Chi-squared|||Physician Recommendation of Mental Health Care at baseline.||||0.87
72542861|NCT02273206|144615828|SUPERIORITY|||||||0.83|||||||Chi-squared|||Physician Recommendation of Mental Health Care at 6 months.||||0.83
72542862|NCT02273206|144615828|SUPERIORITY|||||||0.36|||||||Chi-squared|||Physician Recommendation of Mental Health Care at 12 months.||||0.36
72542863|NCT02273206|144615829|SUPERIORITY|||||||0.95|||||||Chi-squared|||Generalized Anxiety Disorder scale at baseline. Coding of the measure was based on Spitzer, R.L., Kroenke, K., Williams, J.B., \& Lowe, B. (2006).||||0.95
72542864|NCT02273206|144615829|SUPERIORITY|||||||0.08|||||||Chi-squared|||Generalized Anxiety Disorder scale score at 6 months. Coding of the measure was based on Spitzer, R.L., Kroenke, K., Williams, J.B., \& Lowe, B. (2006).||||0.08
72542865|NCT02273206|144615829|SUPERIORITY|||||||0.27|||||||Chi-squared|||Generalized Anxiety Disorder scale score at 12 months. Coding of the measure was based on Spitzer, R.L., Kroenke, K., Williams, J.B., \& Lowe, B. (2006).||||0.27
72542866|NCT02273206|144615830|SUPERIORITY|||||||0.54|||||||Chi-squared|||Medical Outcomes Study Health Survey at baseline. Continuous summary score was converted into 4 categories using quartiles as cut-points.||||0.54
72542867|NCT02273206|144615830|SUPERIORITY|||||||0.68|||||||Chi-squared|||Medical Outcomes Study Health Survey at 6 months. Continuous summary score was converted into 4 categories using quartiles as cut-points.||||0.68
72542868|NCT02273206|144615830|SUPERIORITY|||||||0.68|||||||Chi-squared|||Medical Outcomes Study Health Survey at 12 months. Continuous summary score was converted into 4 categories using quartiles as cut-points.||||0.68
72542869|NCT02273206|144615831|SUPERIORITY|||||||0.74|||||||Chi-squared|||Colorectal Cancer Screening attitudes at baseline. Continuous summary score was converted into 4 categories using quartiles as cut-points.||||0.74
72542870|NCT02273206|144615831|SUPERIORITY|||||||0.86|||||||Chi-squared|||Colorectal Cancer Screening attitudes at 6 months. Continuous summary score was converted into 4 categories using quartiles as cut-points.||||0.86
72410646|NCT00129259|144329676|SUPERIORITY_OR_OTHER|||||||0.11||95.0|||||ANCOVA|ANCOVA adjusts for baseline daily insulin use per kg||"Null hypothesis: The mean change from baseline to Month 24 in daily insulin use per kg does not differ between the treatment and control groups.~Alternative hypothesis: The mean change from baseline to Month 24 in daily insulin use per kg differs between the treatment and control groups."||||0.110
72410647|NCT00023452|144329702|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The noninferiority test statistic was based on the difference of the nonparametric Kaplan-Meier estimators. The asymptotic variance of the test statistic was obtained through Greenwood's formula and a two-sided 95% confidence interval (CI) was constructed for the difference. If the upper bound of the CI was smaller than the noninferiority margin 0.75%, then the null hypothesis would be rejected and noninferiority could be claimed.|Difference in Cumulative TB Disease Rate|-0.24|||||ONE_SIDED|95.0||0.01|||||The difference in cumulative TB disease rate is the rate in the 3RPT/INH arm minus the rate in the 9INH arm.|||0.01||
72410648|NCT00023452|144329703|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The noninferiority test statistic was based on the difference of the nonparametric Kaplan-Meier estimators. The asymptotic variance of the test statistic was obtained through Greenwood's formula and a two-sided 95% CI was constructed for the difference. If the upper bound of the CI was smaller than the noninferiority margin 0.75%, then the null hypothesis would be rejected and noninferiority could be claimed.|Difference in Cumulative TB Rate|-0.21|||||ONE_SIDED|95.0||0.04|||||The difference in cumulative TB disease rate is the percentage in the 3RPT/INH arm minus the percentage in the 9INH arm.|||0.04||
72410649|NCT00023452|144329704|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The noninferiority test statistic was based on the difference of the nonparametric Kaplan-Meier estimators. The asymptotic variance of the test statistic was obtained through Greenwood's formula and a two-sided 95% CI was constructed for the difference. If the upper bound of the CI was smaller than the noninferiority margin 0.75%, then the null hypothesis would be rejected and noninferiority could be claimed.|Difference in Cumulative TB Disease Rate|-0.25|||||ONE_SIDED|95.0||0.03|||||The difference in cumulative TB disease rate is the percentage in the 3RPT/INH arm minus the percentage in the 9INH arm.|||0.03||
72410650|NCT00023452|144329705|SUPERIORITY_OR_OTHER_LEGACY|||||||0.02||95.0|||||Chi-squared|||||||0.02
72410651|NCT00023452|144329706|SUPERIORITY_OR_OTHER_LEGACY|||||||0.24||95.0|||||Chi-squared|||Grade 3 Drug Toxicity||||0.24
72410652|NCT00023452|144329706|SUPERIORITY_OR_OTHER_LEGACY|||||||0.59||95.0|||||Chi-squared|||Grade 4 Drug Toxicity||||0.59
72410653|NCT00023452|144329707|SUPERIORITY_OR_OTHER_LEGACY|||||||0.22||95.0|||||Chi-squared|||||||0.22
72410654|NCT00023452|144329709|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||Chi-squared|||||||<0.001
72410655|NCT00023452|144329710|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||Chi-squared|||||||<0.0001
72421507|NCT01342458|144354198|SUPERIORITY_OR_OTHER|||||||0.015|TWO_SIDED||||||Mixed Models Analysis|||We used a casewise two-way ANOVA for repeated measures (two independent groups and three repeated measures/assessments), followed by a post hoc Newman-Keuls to verify the interaction effect of group vs. time between T0 (baseline), T3 (3th month) and T6 (6th month).||||0.015
72421508|NCT01342458|144354198|SUPERIORITY_OR_OTHER||Effect size|0.66|||<|0.001|TWO_SIDED||||||post hoc Newman-Keuls|||From baseline to 3rd month.||||<0.001
72542871|NCT02273206|144615831|SUPERIORITY|||||||0.79|||||||Chi-squared|||Colorectal Cancer Screening attitudes at 12 months. Continuous summary score was converted into 4 categories using quartiles as cut-points.||||0.79
72542872|NCT02273206|144615831|SUPERIORITY|||||||0.91|||||||Chi-squared|||Breast Cancer Screening attitudes at baseline. Continuous summary score was converted into 4 categories using quartiles as cut-points.||||0.91
72542873|NCT02273206|144615831|SUPERIORITY|||||||0.71|||||||Chi-squared|||Breast Cancer Screening attitudes at 6 months. Continuous summary score was converted into 4 categories using quartiles as cut-points.||||0.71
72542874|NCT02273206|144615831|SUPERIORITY|||||||0.77|||||||Chi-squared|||Breast Cancer Screening attitudes at 12 months. Continuous summary score was converted into 4 categories using quartiles as cut-points.||||0.77
72542875|NCT02273206|144615831|SUPERIORITY|||||||0.64|||||||Chi-squared|||Cervical Cancer Screening attitudes at baseline. Continuous summary score was converted into 4 categories using quartiles as cut-points.||||0.64
72542876|NCT02273206|144615831|SUPERIORITY|||||||0.11|||||||Chi-squared|||Cervical Cancer Screening attitudes at 6 months. Continuous summary score was converted into 4 categories using quartiles as cut-points.||||0.11
72542877|NCT02273206|144615831|SUPERIORITY|||||||1|||||||Chi-squared|||Cervical Cancer Screening attitudes at 12 months. Continuous summary score was converted into 4 categories using quartiles as cut-points.||||1.00
72542878|NCT02273206|144615833|SUPERIORITY|||||||0.56|||||||Chi-squared|||Satisfaction with decision to participate in Mental Health Care at 12 months. Recoding of the continuous measure was based on quartiles.||||0.56
72542879|NCT02273206|144615834|SUPERIORITY|||||||0.18|||||||Chi-squared|||Devaluation-Discrimination Scale Score at baseline. Continuous summary score was converted into 4 categories using quartiles as cut-points.||||0.18
72577401|NCT02047734|144681512|SUPERIORITY||Difference in means|0.043||||0.248|TWO_SIDED|95.0|-0.03|0.116|||ANCOVA|Based on the analysis of covariance model, adjusted for region, Baseline EDSS category, and Baseline MSFC Z-score|Difference in means are based on the analysis of covariance model, adjusted for region (Eastern Europe vs Rest of the World), Baseline EDSS category, and the Baseline MSFC Z-score.|||0.116|-0.030|0.2480
72577402|NCT02047734|144681512|SUPERIORITY||Difference in means|0.093||||0.0123|TWO_SIDED|95.0|0.02|0.165|||ANCOVA|Based on the analysis of covariance model, adjusted for region, Baseline EDSS category, and Baseline MSFC Z-score|Difference in means based on the analysis of covariance model, adjusted for region (Eastern Europe vs Rest of the World), Baseline EDSS category, and the Baseline MSFC Z-score.|||0.165|0.020|0.0123
72542880|NCT02273206|144615834|SUPERIORITY|||||||0.32|||||||Chi-squared|||Devaluation-Discrimination Scale score at 12 months. Continuous summary score was converted into 4 categories using quartiles as cut-points.||||0.32
72542881|NCT02273206|144615835|SUPERIORITY|||||||0.5|||||||Chi-squared|||Ambulatory Care Experiences - Shared Decision Making at baseline. Continuous summary score was converted into 4 categories using quartiles as cut-points.||||0.50
72542882|NCT02273206|144615835|SUPERIORITY|||||||0.51|||||||Chi-squared|||Ambulatory Care Experiences - Shared Decision Making at six months. Continuous summary score was converted into 4 categories using quartiles as cut-points.||||0.51
72542883|NCT02273206|144615835|SUPERIORITY|||||||0.02|||||||Chi-squared|||Ambulatory Care Experiences - Shared Decision Making at twelve months. Continuous summary score was converted into 4 categories using quartiles as cut-points.||||0.02
72542884|NCT02273206|144615835|SUPERIORITY|||||||0.91|||||||Chi-squared|||Ambulatory Care Experiences - Access at baseline. Continuous summary score was converted into 4 categories using quartiles as cut-points.||||0.91
72542885|NCT02273206|144615835|SUPERIORITY|||||||0.69|||||||Chi-squared|||Ambulatory Care Experiences - Access at six months. Continuous summary score was converted into 4 categories using quartiles as cut-points.||||0.69
72542886|NCT02273206|144615835|SUPERIORITY|||||||0.63|||||||Chi-squared|||Ambulatory Care Experiences - Access at twelve months. Continuous summary score was converted into 4 categories using quartiles as cut-points.||||0.63
72542887|NCT02273206|144615835|SUPERIORITY|||||||0.55|||||||Chi-squared|||Ambulatory Care Experiences - Care Coordination at baseline. Continuous summary score was converted into 4 categories using quartiles as cut-points.||||0.55
72542888|NCT02273206|144615835|SUPERIORITY|||||||0.34|||||||Chi-squared|||Ambulatory Care Experiences - Care Coordination at six months. Continuous summary score was converted into 4 categories using quartiles as cut-points.||||0.34
72542889|NCT02273206|144615835|SUPERIORITY|||||||0.19|||||||Chi-squared|||Ambulatory Care Experiences - Care Coordination at twelve months. Continuous summary score was converted into 4 categories using quartiles as cut-points.||||0.19
72577403|NCT02047734|144681513|SUPERIORITY||Difference in means|1.345||||0.0988|TWO_SIDED|95.0|-0.252|2.943|||ANCOVA|Based on the analysis of covariance model, adjusted for region, Baseline EDSS category, and Baseline summary score|Difference in means based on the analysis of covariance model, adjusted for region (Eastern Europe vs Rest of the World), Baseline EDSS category, and Baseline summary score.|Analysis of Physical Health Composite Summary Score||2.943|-0.252|0.0988
72577404|NCT02047734|144681513|SUPERIORITY||Difference in means|1.849||||0.0228|TWO_SIDED|95.0|0.258|3.44|||ANCOVA|Based on the analysis of covariance model, adjusted for region, Baseline EDSS category, and Baseline summary score.|Difference in means based on the analysis of covariance model, adjusted for region (Eastern Europe vs Rest of the World), Baseline EDSS category, and Baseline summary score.|Analysis of Physical Health Composite Summary Score||3.440|0.258|0.0228
72577405|NCT02047734|144681513|SUPERIORITY||Difference in means|0.38||||0.6997|TWO_SIDED|95.0|-1.553|2.313|||ANCOVA|Based on the analysis of covariance model, adjusted for region, Baseline EDSS category, and Baseline summary score|Difference in means based on the analysis of covariance model, adjusted for region (Eastern Europe vs Rest of the World), Baseline EDSS category, and Baseline summary score.|Analysis of Mental Health Composite Summary Score||2.313|-1.553|0.6997
72577406|NCT02047734|144681513|SUPERIORITY||Difference in means|0.587||||0.5501|TWO_SIDED|95.0|-1.339|2.513|||ANCOVA|Based on the analysis of covariance model, adjusted for region, Baseline EDSS category, and the Baseline summary score|Difference in means based on the analysis of covariance model, adjusted for region (Eastern Europe vs Rest of the World), Baseline EDSS category, and Baseline summary score.|Analysis of Mental Health Composite Summary Score||2.513|-1.339|0.5501
72577407|NCT02047734|144681515|SUPERIORITY||||||<|0.0001|||||||Rank ANCOVA|Adjusted for region and Baseline EDSS category, with the dependent variable as the residual of the rank of brain volume at Baseline||||||<0.0001
72577408|NCT02047734|144681515|SUPERIORITY||||||<|0.0001|||||||Rank ANCOVA|Adjusted for region and Baseline EDSS category, with the dependent variable as the residual of the rank of brain volume at Baseline||||||<0.0001
72577409|NCT00789035|144681539|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.52|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001|TWO_SIDED|95.0|-0.74|-0.29||No formal testing so adjustment for multiple comparisons was not necessary.|ANCOVA|Based on ANCOVA with terms for baseline, treatment, number of previous anti-diabetic medications and country.|Difference calculated as empa 5mg minus placebo|||-0.29|-0.74|<0.0001
72577410|NCT00789035|144681539|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.57|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001|TWO_SIDED|95.0|-0.8|-0.35||No formal testing so adjustment for multiple comparisons was not necessary.|ANCOVA|Based on ANCOVA with terms for baseline, treatment, number of previous anti-diabetic medications and country.|Difference calculated as empa 10mg minus placebo|||-0.35|-0.80|<0.0001
72577411|NCT00789035|144681539|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.72|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001|TWO_SIDED|95.0|-0.94|-0.5||No formal testing so adjustment for multiple comparisons was not necessary.|ANCOVA|Based on ANCOVA with terms for baseline, treatment, number of previous anti-diabetic medications and country.|Difference calculated as empa 25mg minus placebo|||-0.50|-0.94|<0.0001
72577412|NCT01651793|144681647|SUPERIORITY|||||||0.05||||||P value reference to the beverage x time interaction effect|ANCOVA|||Hypotheses were tested using a series (all outcome variables) of 2 Treatment x 4 Time point, repeated measures ANCOVAs that controlled for the prior night's sleep. Primary interests were the presence of statistically significant interactions of time and either cocoa versus placebo, cocoa + caffeine versus cocoa, or cocoa + caffeine versus caffeine-only. Significant interactions were decomposed using one-way ANOVAs and t-tests with familywise error controlled using LSD post-hoc tests.||||0.05
72577413|NCT02892149|144681654|NON_INFERIORITY|Establishment of non-inferiority was based on a margin of -0.75 g/dL applied to the difference in mean change: Vadadustat minus Darbepoetin alfa.|Least squares mean difference|-0.17|STANDARD_ERROR_OF_MEAN|0.03|||TWO_SIDED|95.0|-0.23|-0.1||||||Treatment comparison: Vadadustat minus Darbepoetin Alfa||-0.10|-0.23|
72542890|NCT02273206|144615835|SUPERIORITY|||||||0.47|||||||Chi-squared|||Ambulatory Care Experiences - Quality at baseline. Continuous summary score was converted into 4 categories using quartiles as cut-points.||||0.47
72542891|NCT02273206|144615835|SUPERIORITY|||||||0.38|||||||Chi-squared|||Ambulatory Care Experiences - Quality at six months. Continuous summary score was converted into 4 categories using quartiles as cut-points.||||0.38
72542892|NCT02273206|144615835|SUPERIORITY|||||||0.98|||||||Chi-squared|||Ambulatory Care Experiences - Quality at twelve months. Continuous summary score was converted into 4 categories using quartiles as cut-points.||||0.98
72542893|NCT02273206|144615836|SUPERIORITY|||||||0.78|||||||Chi-squared|||Medication Adherence at baseline. Coding of the measure was based on Morisky et al. (2008).||||0.78
72542894|NCT02273206|144615836|SUPERIORITY|||||||0.2|||||||Chi-squared|||Medication Adherence at 6 months. Coding of the measure was based on Morisky et al. (2008).||||0.20
72542895|NCT02273206|144615836|SUPERIORITY|||||||0.77|||||||Chi-squared|||Medication Adherence at 12 Months. Coding of the measure was based on Morisky et al. (2008).||||0.77
72542896|NCT02273206|144615837|SUPERIORITY|||||||0.7|||||||Chi-squared|||Self-efficacy at baseline.Continuous summary score was converted into 4 categories using quartiles as cut-points.||||0.70
72628712|NCT02941614|144785118|OTHER|Conducted test of null hypothesis of no difference vs any, between intervention and control sites at three different time periods (6- vs. 3-months, 12- vs. 6-months, 12- vs. 3-months), as well as omnibus test of treatment-by-time interaction|see above|0.73||||0.35|TWO_SIDED|95.0|-0.79|2.24|||Mixed Models Analysis|We used a difference-in-differences model to estimate the time, treatment, and time-by-treatment effects.||The data below is for the Fact-B 6 month Breast Cancer Subscale||2.24|-0.79|0.35
72628713|NCT02941614|144785118|OTHER|Conducted test of null hypothesis of no difference vs any, between intervention and control sites at three different time periods (6- vs. 3-months, 12- vs. 6-months, 12- vs. 3-months), as well as omnibus test of treatment-by-time interaction|see above|0.6||||0.42|TWO_SIDED|95.0|-0.88|2.09|||Mixed Models Analysis|We used a difference-in-differences model to estimate the time, treatment, and time-by-treatment effects.||The data below is for the Fact-B 12 month Breast Cancer Subscale||2.09|-0.88|0.42
72628714|NCT02941614|144785119|OTHER|Conducted test of null hypothesis of no difference vs any, between intervention and control sites at three different time periods (6- vs. 3-months, 12- vs. 6-months, 12- vs. 3-months), as well as omnibus test of treatment-by-time interaction.|see above|-0.03||||0.59|TWO_SIDED|95.0|-0.15|0.09||We used a difference-in-differences model to estimate the time, treatment, and time-by-treatment effects|Mixed Models Analysis|||Data below is for the BCPT survey 3 month Total Score.||0.09|-0.15|0.59
72628715|NCT02941614|144785119|OTHER|Conducted test of null hypothesis of no difference vs any, between intervention and control sites at three different time periods (6- vs. 3-months, 12- vs. 6-months, 12- vs. 3-months), as well as omnibus test of treatment-by-time interaction|see above|0.05||||0.47|TWO_SIDED|95.0|-0.09|0.19|||Mixed Models Analysis|We used a difference-in-differences model to estimate the time, treatment, and time-by-treatment effects||The data below is the BCPT survey 6 month Total Score||0.19|-0.09|0.47
72628716|NCT02941614|144785119|OTHER|Conducted test of null hypothesis of no difference vs any, between intervention and control sites at three different time periods (6- vs. 3-months, 12- vs. 6-months, 12- vs. 3-months), as well as omnibus test of treatment-by-time interaction|see above|-0.06||||0.37|TWO_SIDED|95.0|-0.2|0.07|||Mixed Models Analysis|We used a difference-in-differences model to estimate the time, treatment, and time-by-treatment effects||The data below is the BCPT survey 12 month Total Score||0.07|-0.20|0.37
72628717|NCT02941614|144785119|OTHER|Conducted test of null hypothesis of no difference vs any, between intervention and control sites at three different time periods (6- vs. 3-months, 12- vs. 6-months, 12- vs. 3-months), as well as omnibus test of treatment-by-time interaction|see above|-0.05||||0.65|TWO_SIDED|95.0|-0.26|0.17|||Mixed Models Analysis|We used a difference-in-differences model to estimate the time, treatment, and time-by-treatment effects||The data below is the BCPT survey 3 month Hot Flashes Sub-Scale||0.17|-0.26|0.65
72628718|NCT02941614|144785119|OTHER|Conducted test of null hypothesis of no difference vs any, between intervention and control sites at three different time periods (6- vs. 3-months, 12- vs. 6-months, 12- vs. 3-months), as well as omnibus test of treatment-by-time interaction|see above|0.08||||0.54|TWO_SIDED|95.0|-0.17|0.33|||Mixed Models Analysis|We used a difference-in-differences model to estimate the time, treatment, and time-by-treatment effects||The data below is the BCPT survey 6 month Hot Flashes Sub-Scale||0.33|-0.17|0.54
72628719|NCT02941614|144785119|OTHER|Conducted test of null hypothesis of no difference vs any, between intervention and control sites at three different time periods (6- vs. 3-months, 12- vs. 6-months, 12- vs. 3-months), as well as omnibus test of treatment-by-time interaction|see above|-0.02||||0.87|TWO_SIDED|95.0|-0.27|0.22|||Mixed Models Analysis|We used a difference-in-differences model to estimate the time, treatment, and time-by-treatment effects||The data below is the BCPT survey 12 month Hot Flashes Sub-Scale||0.22|-0.27|0.87
72628720|NCT02941614|144785119|OTHER|Conducted test of null hypothesis of no difference vs any, between intervention and control sites at three different time periods (6- vs. 3-months, 12- vs. 6-months, 12- vs. 3-months), as well as omnibus test of treatment-by-time interaction|see above|-0.06||||0.32|TWO_SIDED|95.0|-0.17|0.06|||Mixed Models Analysis|We used a difference-in-differences model to estimate the time, treatment, and time-by-treatment effects||The data below is the BCPT survey 3 month Nausea Sub-Scale||0.06|-0.17|0.32
72628721|NCT02941614|144785119|OTHER|Conducted test of null hypothesis of no difference vs any, between intervention and control sites at three different time periods (6- vs. 3-months, 12- vs. 6-months, 12- vs. 3-months), as well as omnibus test of treatment-by-time interaction|see above|0.0||||0.96|TWO_SIDED|95.0|-0.15|0.14|||Mixed Models Analysis|We used a difference-in-differences model to estimate the time, treatment, and time-by-treatment effects||The data below is the BCPT survey 6 month Nausea Sub-Scale||0.14|-0.15|0.96
72628722|NCT02941614|144785119|OTHER|Conducted test of null hypothesis of no difference vs any, between intervention and control sites at three different time periods (6- vs. 3-months, 12- vs. 6-months, 12- vs. 3-months), as well as omnibus test of treatment-by-time interaction|see above|-0.07||||0.32|TWO_SIDED|95.0|-0.21|0.07|||Mixed Models Analysis|We used a difference-in-differences model to estimate the time, treatment, and time-by-treatment effects||The data below is the BCPT survey 12 month Nausea Sub-Scale||0.07|-0.21|0.32
72542897|NCT02273206|144615837|SUPERIORITY|||||||0.89|||||||Chi-squared|||Self-efficacy at 6 months. Continuous summary score was converted into 4 categories using quartiles as cut-points.||||0.89
72628723|NCT02941614|144785119|OTHER|Conducted test of null hypothesis of no difference vs any, between intervention and control sites at three different time periods (6- vs. 3-months, 12- vs. 6-months, 12- vs. 3-months), as well as omnibus test of treatment-by-time interaction|see above|-0.07||||0.44|TWO_SIDED|95.0|-0.24|0.11|||Mixed Models Analysis|We used a difference-in-differences model to estimate the time, treatment, and time-by-treatment effects||The data below is the BCPT survey 3 month Bladder Control Sub-Scale||0.11|-0.24|0.44
72628724|NCT02941614|144785119|OTHER|Conducted test of null hypothesis of no difference vs any, between intervention and control sites at three different time periods (6- vs. 3-months, 12- vs. 6-months, 12- vs. 3-months), as well as omnibus test of treatment-by-time interaction|see above|0.09||||0.38|TWO_SIDED|95.0|-0.11|0.3|||Mixed Models Analysis|We used a difference-in-differences model to estimate the time, treatment, and time-by-treatment effects||The data below is the BCPT survey 6 month Bladder Control Sub-Scale||0.30|-0.11|0.38
72542898|NCT02273206|144615837|SUPERIORITY|||||||0.95|||||||Chi-squared|||Self-efficacy at 12 months. Continuous summary score was converted into 4 categories using quartiles as cut-points.||||0.95
72628725|NCT02941614|144785119|OTHER|Conducted test of null hypothesis of no difference vs any, between intervention and control sites at three different time periods (6- vs. 3-months, 12- vs. 6-months, 12- vs. 3-months), as well as omnibus test of treatment-by-time interaction|see above|-0.07||||0.47|TWO_SIDED|95.0|-0.28|0.13|||Mixed Models Analysis|We used a difference-in-differences model to estimate the time, treatment, and time-by-treatment effects||The data below is for the BCPT survey 12 month Bladder Control Sub-Scale||0.13|-0.28|0.47
72628726|NCT02941614|144785119|OTHER|Conducted test of null hypothesis of no difference vs any, between intervention and control sites at three different time periods (6- vs. 3-months, 12- vs. 6-months, 12- vs. 3-months), as well as omnibus test of treatment-by-time interaction|see above|-0.17||||0.13|TWO_SIDED|95.0|-0.39|0.05|||Mixed Models Analysis|We used a difference-in-differences model to estimate the time, treatment, and time-by-treatment effects||The data below is the BCPT survey 3 month Vaginal Problems Sub-Scale||0.05|-0.39|0.13
72628727|NCT02941614|144785119|OTHER|Conducted test of null hypothesis of no difference vs any, between intervention and control sites at three different time periods (6- vs. 3-months, 12- vs. 6-months, 12- vs. 3-months), as well as omnibus test of treatment-by-time interaction|see above|-0.29||||0.03|TWO_SIDED|95.0|-0.55|-0.02|||Mixed Models Analysis|We used a difference-in-differences model to estimate the time, treatment, and time-by-treatment effects||The data below is the BCPT survey 6 month Vaginal Problems Sub-Scale||-0.02|-0.55|0.03
72628728|NCT02941614|144785119|OTHER|Conducted test of null hypothesis of no difference vs any, between intervention and control sites at three different time periods (6- vs. 3-months, 12- vs. 6-months, 12- vs. 3-months), as well as omnibus test of treatment-by-time interaction|see above|-0.19||||0.14|TWO_SIDED|95.0|-0.45|0.06|||Mixed Models Analysis|We used a difference-in-differences model to estimate the time, treatment, and time-by-treatment effects||The data below is the BCPT survey 12 month Vaginal Problems Sub-Scale||0.06|-0.45|0.14
72628729|NCT02941614|144785119|OTHER|Conducted test of null hypothesis of no difference vs any, between intervention and control sites at three different time periods (6- vs. 3-months, 12- vs. 6-months, 12- vs. 3-months), as well as omnibus test of treatment-by-time interaction|see above|0.07||||0.53|TWO_SIDED|95.0|-0.14|0.28|||Mixed Models Analysis|We used a difference-in-differences model to estimate the time, treatment, and time-by-treatment effects||The data below is the BCPT survey 3 month Musculoskeletal Pain Sub-Scale||0.28|-0.14|0.53
72628730|NCT02941614|144785119|OTHER|Conducted test of null hypothesis of no difference vs any, between intervention and control sites at three different time periods (6- vs. 3-months, 12- vs. 6-months, 12- vs. 3-months), as well as omnibus test of treatment-by-time interaction|see above|0.1||||0.47|TWO_SIDED|95.0|-0.16|0.35|||Mixed Models Analysis|We used a difference-in-differences model to estimate the time, treatment, and time-by-treatment effects||The data below is the BCPT survey 6 month Musculoskeletal Pain Sub-Scale||0.35|-0.16|0.47
72628731|NCT02941614|144785119|OTHER|Conducted test of null hypothesis of no difference vs any, between intervention and control sites at three different time periods (6- vs. 3-months, 12- vs. 6-months, 12- vs. 3-months), as well as omnibus test of treatment-by-time interaction|see above|0.07||||0.57|TWO_SIDED|95.0|-0.18|0.33|||Mixed Models Analysis|We used a difference-in-differences model to estimate the time, treatment, and time-by-treatment effects||The data below is the BCPT survey 12 month Musculoskeletal Pain Sub-Scale||0.33|-0.18|0.57
72628732|NCT02941614|144785119|OTHER|Conducted test of null hypothesis of no difference vs any, between intervention and control sites at three different time periods (6- vs. 3-months, 12- vs. 6-months, 12- vs. 3-months), as well as omnibus test of treatment-by-time interaction|see above|0.02||||0.85|TWO_SIDED|95.0|-0.18|0.21|||Mixed Models Analysis|We used a difference-in-differences model to estimate the time, treatment, and time-by-treatment effects||The data below is the BCPT survey 3 month Cognitive Problems Sub-Scale||0.21|-0.18|0.85
72628733|NCT02941614|144785119|OTHER|Conducted test of null hypothesis of no difference vs any, between intervention and control sites at three different time periods (6- vs. 3-months, 12- vs. 6-months, 12- vs. 3-months), as well as omnibus test of treatment-by-time interaction|see above|0.1||||0.38|TWO_SIDED|95.0|-0.12|0.32|||Mixed Models Analysis|We used a difference-in-differences model to estimate the time, treatment, and time-by-treatment effects||The data below is the BCPT survey 6 month Cognitive Problems Sub-Scale||0.32|-0.12|0.38
72628734|NCT02941614|144785119|OTHER|Conducted test of null hypothesis of no difference vs any, between intervention and control sites at three different time periods (6- vs. 3-months, 12- vs. 6-months, 12- vs. 3-months), as well as omnibus test of treatment-by-time interaction|see above|-0.13||||0.23|TWO_SIDED|95.0|-0.35|0.09|||Mixed Models Analysis|We used a difference-in-differences model to estimate the time, treatment, and time-by-treatment effects||The data below is the BCPT survey 12 month Cognitive Problems Sub-Scale||0.09|-0.35|0.23
72628735|NCT02941614|144785119|OTHER|Conducted test of null hypothesis of no difference vs any, between intervention and control sites at three different time periods (6- vs. 3-months, 12- vs. 6-months, 12- vs. 3-months), as well as omnibus test of treatment-by-time interaction|see above|-0.14||||0.18|TWO_SIDED|95.0|-0.35|0.07|||Mixed Models Analysis|We used a difference-in-differences model to estimate the time, treatment, and time-by-treatment effects||The data below is the BCPT survey 3 month Weight Problems Sub-Scale||0.07|-0.35|0.18
72628736|NCT02941614|144785119|OTHER|Conducted test of null hypothesis of no difference vs any, between intervention and control sites at three different time periods (6- vs. 3-months, 12- vs. 6-months, 12- vs. 3-months), as well as omnibus test of treatment-by-time interaction|see above|-0.12||||0.35|TWO_SIDED|95.0|-0.36|0.13|||Mixed Models Analysis|We used a difference-in-differences model to estimate the time, treatment, and time-by-treatment effects||The data below is the BCPT survey 6 month Weight Problems Sub-Scale||0.13|-0.36|0.35
72628737|NCT02941614|144785119|OTHER|Conducted test of null hypothesis of no difference vs any, between intervention and control sites at three different time periods (6- vs. 3-months, 12- vs. 6-months, 12- vs. 3-months), as well as omnibus test of treatment-by-time interaction|see above|-0.12||||0.34|TWO_SIDED|95.0|-0.36|0.12|||Mixed Models Analysis|We used a difference-in-differences model to estimate the time, treatment, and time-by-treatment effects||The data below is the BCPT survey 12 month Weight Problems Sub-Scale||0.12|-0.36|0.34
72628738|NCT02941614|144785119|OTHER|Conducted test of null hypothesis of no difference vs any, between intervention and control sites at three different time periods (6- vs. 3-months, 12- vs. 6-months, 12- vs. 3-months), as well as omnibus test of treatment-by-time interaction|see above|0.09||||0.22|TWO_SIDED|95.0|-0.06|0.25|||Mixed Models Analysis|We used a difference-in-differences model to estimate the time, treatment, and time-by-treatment effects||The data below is the BCPT survey 3 month Arm Problems Sub-Scale||0.25|-0.06|0.22
72628739|NCT02941614|144785119|OTHER|Conducted test of null hypothesis of no difference vs any, between intervention and control sites at three different time periods (6- vs. 3-months, 12- vs. 6-months, 12- vs. 3-months), as well as omnibus test of treatment-by-time interaction|see above|0.11||||0.26|TWO_SIDED|95.0|-0.08|0.29|||Mixed Models Analysis|We used a difference-in-differences model to estimate the time, treatment, and time-by-treatment effects||The data below is the BCPT survey 6 month Arm Problems Sub-Scale||0.29|-0.08|0.26
72628740|NCT02941614|144785119|OTHER|Conducted test of null hypothesis of no difference vs any, between intervention and control sites at three different time periods (6- vs. 3-months, 12- vs. 6-months, 12- vs. 3-months), as well as omnibus test of treatment-by-time interaction|see above|0.09||||0.34|TWO_SIDED|95.0|-0.09|0.27|||Mixed Models Analysis|We used a difference-in-differences model to estimate the time, treatment, and time-by-treatment effects||The data below is the BCPT survey 12 month Arm Problems Sub-Scale||0.27|-0.09|0.34
72628741|NCT02941614|144785120|OTHER||Rate Ratio|0.86||||0.006|TWO_SIDED|95.0|0.77|0.96|||Regression, Poisson|||||0.96|0.77|0.006
72628742|NCT02941614|144785121|OTHER||Rate Ratio|1.07||||0.356|TWO_SIDED|95.0|0.93|1.07|||Regression, Poisson|||||1.07|0.93|0.356
72628743|NCT02941614|144785122|OTHER||Rate Ratio|1.02||||0.919|TWO_SIDED|95.0|0.73|1.41|||Regression/Poisson|||||1.41|0.73|0.919
72628744|NCT02941614|144785123|OTHER||Rate Ratio|1.16||||0.367|TWO_SIDED|95.0|0.84|1.62|||Regression, Poisson|||The data below applies to Emergency Department visits||1.62|0.84|0.367
72628745|NCT02941614|144785123|OTHER||Rate Ratio|0.84||||0.497|TWO_SIDED|95.0|0.51|1.38|||Regression, Poisson|||The data below applies to Urgent Care visits||1.38|0.51|0.497
72628746|NCT01908140|144785150|NON_INFERIORITY_OR_EQUIVALENCE|non-inferiority margin=-0,055 L|Mean Difference (Final Values)|0.093|||<|0.001|TWO_SIDED|95.0|0.063|0.123|||MMRM|If non-inferiority on the PP was achieved then switch to superiority was tested on the ITT.||This sample size of 900 had 90% power to show that the lower bound of the two-sided 95% confidence interval for the difference between Aclidinium bromide 400 μg/Formoterol Fumarate 12 μg and SeretideTM AccuhalerTM (50/500 μg) in Peak FEV1 at 24 weeks is above -0,055 L||0.123|0.063|<0.001
72628747|NCT01908140|144785151|NON_INFERIORITY_OR_EQUIVALENCE|non-inferiority limit -0.5 units|Mean Difference (Final Values)|-0.001|||>|0.05|TWO_SIDED|95.0|-0.46|0.46|||MMRM|||The total sample size provided 81% nominal power to show that the lower bound of the two-sided 95 confidence interval for the difference between Aclidinium bromide 400 μg/Formoterol fumarate 12 μg and SeretideTM AccuhalerTM (50/500 μg) in transitional dyspnoea index (TDI) at 24 weeks is above -0,5||0.46|-0.46|>0.05
72628748|NCT02013609|144785161|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Mixed Models Analysis|Mixed model repeated measure (MMRM) with model terms: Baseline, visit, and Baseline by visit interaction||The null hypothesis of zero in mean change from Baseline in MADRS total score at Week 12 was tested at significance level of 0.05. Since this is an exploratory trial, no methods to control type I error rate were performed.||||<0.0001
72628749|NCT02013609|144785162|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Mixed Models Analysis|MMRM with model terms: Baseline, visit, and Baseline by visit interaction||Statistical analysis at Week 12.||||<0.0001
72628750|NCT02013609|144785167|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Mixed Models Analysis|MMRM with model terms: Baseline, visit, and Baseline by visit interaction.||Statistical analysis at Week 12.||||<0.0001
72628751|NCT02013609|144785168|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Mixed Models Analysis|MMRM with model terms: Baseline, visit, and Baseline by visit interaction||Statistical analysis at Week 12.||||<0.0001
72628752|NCT02013609|144785169|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||The p-value is the same for each of single item sub-scores of tasks: work/ school, social life and family life/ home responsibilities|Mixed Models Analysis|MMRM with model terms: Baseline, visit, and Baseline by visit interaction||Statistical analysis at Week 12 of single item sub-scores of tasks: work/ school, social life and family life/ home responsibilities||||<0.0001
72628753|NCT02013609|144785170|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Mixed Models Analysis|MMRM with model terms: Baseline, visit, and Baseline by visit interaction||Statistical analysis at Week 12.||||<0.0001
72628754|NCT02013609|144785171|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Mixed Models Analysis|MMRM with model terms: Baseline, visit, and Baseline by visit interaction||Statistical analysis at Week 12||||<0.0001
72628755|NCT02013609|144785172|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Mixed Models Analysis|MMRM with model terms: Baseline, visit, and Baseline by visit interaction||Statistical analysis at Week 12||||<0.0001
72628756|NCT02013609|144785173|SUPERIORITY_OR_OTHER|||||||0.3439|TWO_SIDED||||||t-test, 2 sided|p-value for change from Baseline using t-test.||Statistical analysis at Week 12 for p-inhibition failures (Go cues)||||0.3439
72628757|NCT02013609|144785173|SUPERIORITY_OR_OTHER|||||||0.3385|TWO_SIDED||||||t-test, 2 sided|p-value for change from Baseline using t-test.||Statistical analysis at Week 12 for p-inhibition failures (No-Go cues)||||0.3385
72628758|NCT02013609|144785174|SUPERIORITY_OR_OTHER|||||||0.2052|TWO_SIDED||||||t-test, 2 sided|p-value for change from Baseline using t-test.||Statistical analysis at Week 12 for mean reaction time (Go cues)||||0.2052
72628759|NCT02013609|144785174|SUPERIORITY_OR_OTHER|||||||0.3224|TWO_SIDED||||||t-test, 2 sided|p-value for change from Baseline using t-test.||Statistical analysis at Week 12 for mean reaction time (No-Go cues)||||0.3224
72628760|NCT02013609|144785175|SUPERIORITY_OR_OTHER|||||||0.3169|TWO_SIDED||||||t-test, 2 sided|p-value for change from Baseline using t-test.||Statistical analysis at Week 12||||0.3169
72628761|NCT02013609|144785176|SUPERIORITY_OR_OTHER|||||||0.3352|TWO_SIDED||||||t-test, 2 sided|||Statistical analysis at Week 12||||0.3352
72628762|NCT02013609|144785177|SUPERIORITY_OR_OTHER|||||||0.3517|TWO_SIDED||||||t-test, 2 sided|||Statistical analysis at Week 12 for delay discounting task k value||||0.3517
72628763|NCT02013609|144785177|SUPERIORITY_OR_OTHER|||||||0.3799|TWO_SIDED||||||t-test, 2 sided|||Statistical analysis at Week 12 for delay discounting task h value||||0.3799
72628764|NCT02013609|144785178|SUPERIORITY_OR_OTHER|||||||0.261|TWO_SIDED||||||t-test, 2 sided|||Statistical analysis at Week 12 (AUC for food)||||0.2610
72628765|NCT02013609|144785178|SUPERIORITY_OR_OTHER|||||||0.8138|TWO_SIDED||||||t-test, 2 sided|||Statistical analysis at Week 12 (AUC for money)||||0.8138
72628766|NCT02013609|144785179|SUPERIORITY_OR_OTHER|||||||0.8138|TWO_SIDED||||||t-test, 2 sided|||Statistical analysis at Week 12 (AUC for money)||||0.8138
72628767|NCT02013609|144785180|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Mixed Models Analysis|MMRM with model terms: Baseline, visit, and Baseline by visit interaction||Statistical analysis at Week 12.||||<0.0001
72628768|NCT00856609|144785181|OTHER||Slope|-624.8||||0.01|TWO_SIDED|95.0|-901.8|-347.8|||ANCOVA|||||-347.8|-901.8|0.01
72410656|NCT00023452|144329711|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The noninferiority test statistic was based on the difference of the nonparametric Kaplan-Meier estimators. The asymptotic variance of the test statistic was obtained through Greenwood's formula and a two-sided 95% CI was constructed for the difference. If the upper bound of the CI was smaller than the noninferiority margin 0.75%, then the null hypothesis would be rejected and noninferiority could be claimed.|Difference in Cumulative TB Disease Rate|-0.19|||||ONE_SIDED|95.0||0.06|||||The difference in cumulative TB disease rate is the percentage in the 3RPT/INH arm minus the percentage in the 9INH arm.|||0.06||
72410657|NCT02939105|144329739|OTHER||success proportion|86.7|||||TWO_SIDED|95.0|69.3|96.2||||||||96.2|69.3|
72410658|NCT01940705|144329741|SUPERIORITY||Mean Difference (Final Values)|5.578||||0.001|TWO_SIDED||||||ANOVA|||Analysis for Hearing Aid Skills and Knowledge test Skills scale||||0.001
72410659|NCT01940705|144329741|SUPERIORITY||Mean Difference (Final Values)|4.235||||0.003|TWO_SIDED||||||ANOVA|||Analysis for Hearing Aid Skills and Knowledge test Knowledge scale||||0.003
72410660|NCT01940705|144329742|SUPERIORITY||Mean Difference (Final Values)|0.956||||0.414|TWO_SIDED||||||ANOVA|||||||0.414
72410661|NCT01940705|144329743|SUPERIORITY||Mean Difference (Final Values)|0.27||||0.847|TWO_SIDED||||||ANOVA|||||||0.847
72410662|NCT00139997|144329744|SUPERIORITY_OR_OTHER|||||||0.028||95.0|||||t-test, 2 sided|||||||0.028
72410663|NCT03779841|144329753|SUPERIORITY||Risk Ratio (RR)|0.8||||0.1612|TWO_SIDED|95.0|0.58|1.1|||Cochran-Mantel-Haenszel|||P-values and Risk Ratios (and their corresponding 95% CI) for each pairwise comparison of AGN-151607 versus Placebo are obtained from Cochran-Mantel-Haenszel (CMH) test controlling for type of surgery (presence or absence of valve surgery) and age group (\< 65 or ≥ 65 years).||1.10|0.58|0.1612
72628769|NCT00856609|144785182|OTHER||Slope|-24.0||||0.01|TWO_SIDED|95.0|-89.7|41.4|||ANCOVA|||||41.4|-89.7|0.01
72410664|NCT03779841|144329753|SUPERIORITY||Risk Ratio (RR)|1.04||||0.7789|TWO_SIDED|95.0|0.79|1.37|||Cochran-Mantel-Haenszel|||P-values and Risk Ratios (and their corresponding 95% CI) for each pairwise comparison of AGN-151607 versus Placebo are obtained from Cochran-Mantel-Haenszel (CMH) test controlling for type of surgery (presence or absence of valve surgery) and age group (\< 65 or ≥ 65 years).||1.37|0.79|0.7789
72410665|NCT03779841|144329754|SUPERIORITY|||||||0.2972|||||||stratified Wilcoxon (Van Elteren)|||P-value is obtained from stratified Wilcoxon (Van Elteren) test versus Placebo with type of surgery (presence or absence of valve surgery) and age group (\< 65 or ≥ 65 years) as stratification factors.||||0.2972
72410666|NCT03779841|144329754|SUPERIORITY|||||||0.8722|||||||stratified Wilcoxon (Van Elteren)|||P-value is obtained from stratified Wilcoxon (Van Elteren) test versus Placebo with type of surgery (presence or absence of valve surgery) and age group (\< 65 or ≥ 65 years) as stratification factors.||||0.8722
72410667|NCT03779841|144329755|SUPERIORITY||Risk Ratio (RR)|0.99||||0.9814|TWO_SIDED|95.0|0.5|1.96|||Cochran-Mantel-Haenszel|||P-values and Risk Ratios (and their corresponding 95% CI) for each pairwise comparison of AGN-151607 versus Placebo are obtained from Cochran-Mantel-Haenszel (CMH) test controlling for type of surgery (presence or absence of valve surgery) and age group (\< 65 or ≥ 65 years).||1.96|0.50|0.9814
72410668|NCT03779841|144329755|SUPERIORITY||Risk Ratio (RR)|0.99||||0.9715|TWO_SIDED|95.0|0.5|1.97|||Cochran-Mantel-Haenszel|||P-values and Risk Ratios (and their corresponding 95% CI) for each pairwise comparison of AGN-151607 versus Placebo are obtained from Cochran-Mantel-Haenszel (CMH) test controlling for type of surgery (presence or absence of valve surgery) and age group (\< 65 or ≥ 65 years).||1.97|0.50|0.9715
72542899|NCT03063632|144615841|OTHER|||||||||||||||||Per Global Response Score used in Mycosis Fungoides and Sezary Syndrome, Response is assessed by the standard response criteria: Complete Response (CR), complete disappearance of all clinical evidence of disease where all categories (i.e., skin, lymph nodes, viscera, blood) have complete response/noninvolved; Partial Response (PR), regression of measurable disease; Stable Disease (SD), failure to attain CR, PR, or PD.|Simple statistics. Non-responders excluded from analysis.|||
72542900|NCT03063632|144615842|OTHER||||||||||||||||||Kaplan-Meier method|||
72542901|NCT03063632|144615843|OTHER|||||||||||||||||Progression is assessed by the standard response criteria used in Mycosis Fungoides and Sezary Syndrome (skin, lymph nodes, viscera, blood, global). Per Global Response Score, progression is defined as Progressive Disease (PD) in any category (i.e., skin, lymph nodes, viscera, blood).|Kaplan-Meier method|||
72628770|NCT00856609|144785183|OTHER||Slope|-1.48||||0.05|TWO_SIDED|95.0|-3.02|0.05|||ANCOVA|||||0.05|-3.02|0.05
72410669|NCT03779841|144329756|SUPERIORITY|||||||0.1281|||||||Log Rank|||P-value is from stratified log-rank test versus Placebo with type of surgery (presence or absence of valve surgery) and age group (\< 65 or ≥ 65 years) as stratification factors.||||0.1281
72410670|NCT03779841|144329756|SUPERIORITY|||||||0.882|||||||Log Rank|||P-value is from stratified log-rank test versus Placebo with type of surgery (presence or absence of valve surgery) and age group (\< 65 or ≥ 65 years) as stratification factors.||||0.8820
72410671|NCT03779841|144329757|SUPERIORITY||Risk Ratio (RR)|0.79||||0.1623|TWO_SIDED|95.0|0.57|1.1|||Cochran-Mantel-Haenszel|||P-values and Risk Ratios (and their corresponding 95% CI) for each pairwise comparison of AGN-151607 versus Placebo are obtained from Cochran-Mantel-Haenszel (CMH) test controlling for type of surgery (presence or absence of valve surgery) and age group (\< 65 or ≥ 65 years).||1.10|0.57|0.1623
72421509|NCT01342458|144354198|SUPERIORITY_OR_OTHER||Effect size|0.7|||<|0.001|TWO_SIDED||||||post hoc Newman-Keuls|||From baseline to 6th month.||||<0.001
72421510|NCT01342458|144354198|SUPERIORITY_OR_OTHER||Effect size|0.25|||<|0.001|TWO_SIDED||||||post hoc Newman-Keuls|||From baseline to 3rd month.||||<0.001
72542902|NCT03063632|144615844|OTHER||||||||||||||||||Kaplan-Meier method|||
72542903|NCT03063632|144615845|OTHER||||||||||||||||||Binomial distribution|||
72542904|NCT02570165|144615849|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|191.1|||||TWO_SIDED|95.0|101.07|284.26|||||The 95% Bayesian credible interval for the mean difference between batefenterol 37.5 µg dose and placebo (batefenterol 37.5 µg minus placebo) was estimated.|||284.26|101.07|
72628771|NCT00783432|144785186|SUPERIORITY_OR_OTHER|||||||0.368||95.0||||This is the Baseline P-Value|ANOVA|||Sample size was based on ICH Guideline E1:The Extent of Population Exposure to Assess Clinical Safety for Drugs Intended for Long-Term Treatment of Non-Life-Threatening Conditions. Comparisons performed using ANCOVA with baseline as a covariate. The model included treatment group and country as fixed effects to estimate least squares means.||||0.368
72410672|NCT03779841|144329757|SUPERIORITY||Risk Ratio (RR)|1.04||||0.7776|TWO_SIDED|95.0|0.78|1.39|||Cochran-Mantel-Haenszel|||P-values and Risk Ratios (and their corresponding 95% CI) for each pairwise comparison of AGN-151607 versus Placebo are obtained from Cochran-Mantel-Haenszel (CMH) test controlling for type of surgery (presence or absence of valve surgery) and age group (\< 65 or ≥ 65 years).||1.39|0.78|0.7776
72628772|NCT00783432|144785186|SUPERIORITY_OR_OTHER|||||||0.327||95.0||||This P-Value if for Month 1|ANCOVA|||Sample size was based on ICH Guideline E1:The Extent of Population Exposure to Assess Clinical Safety for Drugs Intended for Long-Term Treatment of Non-Life-Threatening Conditions. Comparisons performed using ANCOVA with baseline as a covariate. The model included treatment group and country as fixed effects to estimate least squares means.||||0.327
72628773|NCT00783432|144785186|SUPERIORITY_OR_OTHER|||||||0.991||95.0||||This P-Value is for Month 3|ANCOVA|||Sample size was based on ICH Guideline E1:The Extent of Population Exposure to Assess Clinical Safety for Drugs Intended for Long-Term Treatment of Non-Life-Threatening Conditions. Comparisons performed using ANCOVA with baseline as a covariate. The model included treatment group and country as fixed effects to estimate least squares means.||||0.991
72628774|NCT00783432|144785186|SUPERIORITY_OR_OTHER|||||||0.168||95.0||||This P-Value is for Month 6|ANCOVA|||Sample size was based on ICH Guideline E1:The Extent of Population Exposure to Assess Clinical Safety for Drugs Intended for Long-Term Treatment of Non-Life-Threatening Conditions. Comparisons performed using ANCOVA with baseline as a covariate. The model included treatment group and country as fixed effects to estimate least squares means.||||0.168
72628775|NCT00783432|144785186|SUPERIORITY_OR_OTHER|||||||0.319||95.0||||This P-Value is for Month 9|ANCOVA|||Sample size was based on ICH Guideline E1:The Extent of Population Exposure to Assess Clinical Safety for Drugs Intended for Long-Term Treatment of Non-Life-Threatening Conditions. Comparisons performed using ANCOVA with baseline as a covariate. The model included treatment group and country as fixed effects to estimate least squares means.||||0.319
72628776|NCT00783432|144785186|SUPERIORITY_OR_OTHER|||||||0.725||||||This P-Value is for Month 12/ET|ANCOVA|||Sample size was based on ICH Guideline E1:The Extent of Population Exposure to Assess Clinical Safety for Drugs Intended for Long-Term Treatment of Non-Life-Threatening Conditions. Comparisons performed using ANCOVA with baseline as a covariate. The model included treatment group and country as fixed effects to estimate least squares means.||||0.725
72410673|NCT03779841|144329758|SUPERIORITY||Risk Ratio (RR)|0.79||||0.1603|TWO_SIDED|95.0|0.56|1.1|||Cochran-Mantel-Haenszel|||P-values and Risk Ratios (and their corresponding 95% CI) for each pairwise comparison of AGN-151607 versus Placebo are obtained from Cochran-Mantel-Haenszel (CMH) test controlling for type of surgery (presence or absence of valve surgery) and age group (\< 65 or ≥ 65 years).||1.10|0.56|0.1603
72410674|NCT03779841|144329758|SUPERIORITY||Risk Ratio (RR)|1.06||||0.6706|TWO_SIDED|95.0|0.8|1.42|||Cochran-Mantel-Haenszel|||P-values and Risk Ratios (and their corresponding 95% CI) for each pairwise comparison of AGN-151607 versus Placebo are obtained from Cochran-Mantel-Haenszel (CMH) test controlling for type of surgery (presence or absence of valve surgery) and age group (\< 65 or ≥ 65 years).||1.42|0.80|0.6706
72628777|NCT01436110|144785187|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.037||||0.43|TWO_SIDED|95.0|-0.055|0.128|||ANCOVA|||||0.128|-0.055|0.430
72628778|NCT01436110|144785187|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.102||||0.03|TWO_SIDED|95.0|0.01|0.194|||ANCOVA|||||0.194|0.010|0.030
72628779|NCT03273907|144785200|SUPERIORITY|The primary null hypothesis tested was that the observed rate of clinically relevant complications associated with CyPass Micro-Stent placement and stability is greater than or equal to the performance target rate of 7.00 percent.||||||0.187|||||||Exact one-sided binomial test|P-value is provided from exact one-sided binomial test with type I error 0.05 comparing CyPass System with performance criterion of 7.00 percent.||||||0.1870
72628780|NCT00110214|144785207|NON_INFERIORITY_OR_EQUIVALENCE|Superiority and futility analyses were conducted for the OS end point. The Lan-Demets analog of the Emerson-Fleming sequential boundary was used to maintain the overall significance level of alpha=0.05 while conducting interim analyses on OS. The final analysis was performed when 748 deaths had been observed. An intention-to-treat approach was used in the analysis for all the clinical end points with the exception of toxicity.|Hazard Ratio (HR)|0.91||||0.181|TWO_SIDED|95.0|0.7|1.05||The primary analysis was adjusted for the stratification factors (24-mo survival probability as predicted by a validated nomogram (\<10%,10%-29.9%,\>=30%), age (\<65, \>=65 years) and prior history of arterial events (yes, no)).|Log Rank|||||1.05|0.7|0.181
72628781|NCT00110214|144785208|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||||||<0.001
72628782|NCT00110214|144785209|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.8|||<|0.001|TWO_SIDED|95.0|0.71|0.91||The primary analysis was adjusted for the stratification factors (24-mo survival probability as predicted by a validated nomogram (\<10%,10%-29.9%,\>=30%), age (\<65, \>=65 years) and prior history of arterial events (yes, no)).|Log Rank|||||0.91|0.71|<0.001
72542905|NCT02570165|144615849|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|231.6|||||TWO_SIDED|95.0|149.31|310.02|||||The 95% Bayesian credible interval for differences between each individual batefenterol 75 µg dose and placebo was estimated.|||310.02|149.31|
72542906|NCT02570165|144615849|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|261.8|||||TWO_SIDED|95.0|189.85|332.25|||||The 95% Bayesian credible interval for differences between each individual batefenterol 150 µg dose and placebo was estimated.|||332.25|189.85|
72542907|NCT02570165|144615849|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|281.4|||||TWO_SIDED|95.0|212.35|351.3|||||The 95% Bayesian credible interval for differences between each individual batefenterol 300 µg dose and placebo was estimated.|||351.30|212.35|
72542908|NCT02570165|144615849|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|292.8|||||TWO_SIDED|95.0|223.02|364.42|||||The 95% Bayesian credible interval for differences between each individual batefenterol 600 µg dose and placebo was estimated.|||364.42|223.02|
72628783|NCT01088503|144785211|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.03||||0.7108|TWO_SIDED|95.0|0.88|1.22||Statistical analysis adjusted for the differences in baseline characteristics between participants treated with prasugrel vs. clopidogrel using propensity scoring.|Log Rank|||||1.22|0.88|0.7108
72628784|NCT01088503|144785212|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.464|||||TWO_SIDED||||||||Odds Ratio for selection of Prasugrel for participants with DES vs BMS.|||||
72628785|NCT01088503|144785212|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.23|||||TWO_SIDED||||||||Odds Ratio for selection of Prasugrel for participants with STEMI vs not STEMI|||||
72628786|NCT01088503|144785212|SUPERIORITY_OR_OTHER||Odds Ratio, log|1.657|||||TWO_SIDED||||||||Odds Ratio for selection of Prasugrel for participants who were Other Race vs Caucasian.|||||
72410675|NCT03779841|144329759|SUPERIORITY||Risk Ratio (RR)|0.78||||0.1583|TWO_SIDED|95.0|0.55|1.1|||Cochran-Mantel-Haenszel|||P-values and Risk Ratios (and their corresponding 95% CI) for each pairwise comparison of AGN-151607 versus Placebo are obtained from Cochran-Mantel-Haenszel (CMH) test controlling for type of surgery (presence or absence of valve surgery) and age group (\< 65 or ≥ 65 years).||1.10|0.55|0.1583
72577414|NCT02892149|144681655|NON_INFERIORITY|The prespecified non-inferiority margin was 1.25 (per Food and Drug Administration \[FDA\]) and 1.30 (per European Medicines Agency \[EMA\]).|Hazard Ratio (HR)|0.96||||0.4745|TWO_SIDED|95.0|0.828|1.117|||Log Rank|Based on non-parametric analysis.||Statistical analysis from study AKB-6548-CI-0017 has been reported in this section.||1.117|0.828|0.4745
72577415|NCT02892149|144681655|NON_INFERIORITY|The prespecified non-inferiority margin was 1.25 (per FDA) and 1.30 (per EMA).|Hazard Ratio (HR)|0.96|||=|0.4877|TWO_SIDED|95.0|0.833|1.113|||Log Rank|Based on non-parametric analysis.||MACE analysis was performed on pooled data from studies AKB-6548-CI-0016 (NCT02865850) and AKB-6548-CI-0017 (NCT02892149). Time to first MACE for the Vadadustat and Darbepoetin alfa treatment groups was as follows: participants with events = 355 and 377 respectively; median time to first event (Q1, Q3) = 46.14 (24.71, 77.14) weeks versus 47.00 (22.43, 74.43) weeks, respectively. Statistical analysis from the pooled data has been reported in this section.||1.113|0.833|=0.4877
72577416|NCT02892149|144681656|NON_INFERIORITY|Establishment of non-inferiority was based on a margin of -0.75 g/dL applied to the difference in mean change: Vadadustat minus Darbepoetin alfa.|Least squares mean difference|-0.18|STANDARD_ERROR_OF_MEAN|0.04|||TWO_SIDED|95.0|-0.25|-0.12||||||Treatment comparison: Vadadustat minus Darbepoetin Alfa||-0.12|-0.25|
72577417|NCT02892149|144681657|NON_INFERIORITY|The prespecified non-inferiority margin was 1.25 (per FDA) and 1.30 (per EMA).|Hazard Ratio (HR)|0.96||||0.3718|TWO_SIDED|95.0|0.832|1.097|||Log Rank|Based on non-parametric analysis.||Statistical analysis from study AKB-6548-CI-0017 has been reported in this section.||1.097|0.832|0.3718
72577418|NCT02892149|144681657|NON_INFERIORITY|The prespecified non-inferiority margin was 1.25 (per FDA) and 1.30 (per EMA).|Hazard Ratio (HR)|0.96|||=|0.4096|TWO_SIDED|95.0|0.84|1.096|||Log Rank|Based on non-parametric analysis.||MACE analysis was performed on pooled data from studies AKB-6548-CI-0016 (NCT02865850) and AKB-6548-CI-0017 (NCT02892149). Time to first MACE plus hospitalization for heart failure or thromboembolic event Excluding vascular access thrombosis for the Vadadustat and Darbepoetin alfa treatment groups was as follows: participants with events = 420 and 449 respectively; median time to first event (Q1, Q3) = 42.07 (21.50, 71.14) weeks versus 45.29 (22.29, 72.43) weeks, respectively.||1.096|0.840|=0.4096
72577419|NCT02892149|144681658|NON_INFERIORITY|The prespecified non-inferiority margin was 1.25 (per FDA) and 1.30 (per EMA).|Hazard Ratio (HR)|0.94||||0.3875|TWO_SIDED|95.0|0.777|1.131|||Gray's test|Based on non-parametric analysis.||Statistical analysis from study AKB-6548-CI-0017 has been reported in this section.||1.131|0.777|0.3875
72577420|NCT02892149|144681658|NON_INFERIORITY|The prespecified non-inferiority margin was 1.25 (per FDA) and 1.30 (per EMA).|Hazard Ratio (HR)|0.95|||=|0.5007|TWO_SIDED|95.0|0.795|1.144|||Gray's test|||MACE analysis was performed on pooled data from studies AKB-6548-CI-0016 (NCT02865850) and AKB-6548-CI-0017 (NCT02892149). Time to first cardiovascular MACE for the Vadadustat and Darbepoetin alfa treatment groups was as follows: participants with events = 225 and 242 respectively; median time to first event (Q1, Q3) = 43.29 (21.71, 77.14) weeks versus 45.79 (21.14, 73.86) weeks, respectively. Statistical analysis from the pooled data has been reported in this section.||1.144|0.795|=0.5007
72577421|NCT02892149|144681659|NON_INFERIORITY|The prespecified non-inferiority margin was 1.25 (per FDA) and 1.30 (per EMA).|Hazard Ratio (HR)|0.96||||0.6281|TWO_SIDED|95.0|0.761|1.203|||Gray's test|Based on non-parametric analysis.||Statistical analysis from study AKB-6548-CI-0017 has been reported in this section.||1.203|0.761|0.6281
72577422|NCT02892149|144681659|NON_INFERIORITY|The prespecified non-inferiority margin was 1.25 (per FDA) and 1.30 (per EMA).|Hazard Ratio (HR)|0.96|||=|0.6284|TWO_SIDED|95.0|0.766|1.195|||Gray's test|Based on non-parametric analysis.||MACE analysis was performed on pooled data from studies AKB-6548-CI-0016 (NCT02865850) and AKB-6548-CI-0017 (NCT02892149). Time to first cardiovascular death for the Vadadustat and Darbepoetin alfa treatment groups was as follows: participants with events = 150 and 160 respectively; median time to first event (Q1, Q3) = 43.71 (27.43, 77.14) weeks versus 49.29 (24.43, 74.07) weeks, respectively. Statistical analysis from the pooled data has been reported in this section.||1.195|0.766|=0.6284
72577423|NCT02892149|144681660|NON_INFERIORITY|The prespecified non-inferiority margin was 1.25 (per FDA) and 1.30 (per EMA).|Hazard Ratio (HR)|0.96||||0.5811|TWO_SIDED|95.0|0.816|1.136|||Log Rank|Based on non-parametric analysis.||Statistical analysis from study AKB-6548-CI-0017 has been reported in this section.||1.136|0.816|0.5811
72577424|NCT02892149|144681660|NON_INFERIORITY|The prespecified non-inferiority margin was 1.25 (per FDA) and 1.30 (per EMA).|Hazard Ratio (HR)|0.95|||=|0.4878|TWO_SIDED|95.0|0.812|1.118|||Log Rank|Based on non-parametric analysis.||MACE analysis was performed on pooled data from studies AKB-6548-CI-0016 (NCT02865850) and AKB-6548-CI-0017 (NCT02892149). Time to first all-cause mortality for the Vadadustat and Darbepoetin alfa treatment groups was as follows: participants with events = 291 and 310 respectively; median time to first event (Q1, Q3) = 50.00 (29.71, 79.00) weeks versus 49.57 (25.86, 77.29) weeks, respectively. Statistical analysis from the pooled data has been reported in this section.||1.118|0.812|=0.4878
72577425|NCT00863772|144681683|SUPERIORITY_OR_OTHER_LEGACY||Least squares (LS) mean difference|0.29|STANDARD_ERROR_OF_MEAN|0.37||0.434|TWO_SIDED|95.0|-0.44|1.01|||ANCOVA|||Analysis of co-variance (ANCOVA) model was used with treatment as main effect, baseline value as a covariate, and study site as a random effect.||1.01|-0.44|0.434
72577426|NCT00863772|144681683|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.05|STANDARD_ERROR_OF_MEAN|0.37||0.883|TWO_SIDED|95.0|-0.68|0.79|||ANCOVA|||ANCOVA model was used with treatment as main effect, baseline value as a covariate, and study site as a random effect.||0.79|-0.68|0.883
72628787|NCT01088503|144785212|SUPERIORITY_OR_OTHER||Odds Ratio, log|1.684|||||TWO_SIDED||||||||Odds Ratio for selection of Prasugrel for participants who had cardiogenic shock within 24 hours vs no cardiogenic shock within 24 hours.|||||
72628788|NCT01088503|144785212|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.195|||||TWO_SIDED||||||||Odds Ratio for selection of Prasugrel for participants who were male vs not male.|||||
72421511|NCT01342458|144354198|SUPERIORITY_OR_OTHER||Effect size|0.16|||<|0.001|TWO_SIDED||||||post hoc Newman-Keuls|||From baseline to 6th month.||||<0.001
72628789|NCT01088503|144785212|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.12|||||TWO_SIDED||||||||Odds Ratio for selection of Prasugrel for participants with EQ-5D US index = 1 vs. \<1.|||||
72628790|NCT01088503|144785212|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.116|||||TWO_SIDED||||||||Odds Ratio for selection of Prasugrel for participants who were married vs not married.|||||
72628791|NCT01088503|144785212|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.125|||||TWO_SIDED||||||||Odds Ratio for selection of Prasugrel for participants who had diabetes vs no diabetes.|||||
72628792|NCT01088503|144785212|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.172|||||TWO_SIDED||||||||Odds Ratio for selection of Prasugrel for participants with no BMS or DES placement vs BMS.|||||
72628793|NCT01088503|144785213|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.3||||0.1882|TWO_SIDED|95.0|0.88|1.93||Statistical analysis adjusted for the differences in baseline characteristics between participants treated with prasugrel vs. clopidogrel using propensity scoring.|Log Rank||Hazard ratio (HR) is for the analysis at 12 months.|||1.93|0.88|0.1882
72628794|NCT01088503|144785214|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.967|||||TWO_SIDED|95.0|0.849|1.103|||||Statistical analysis adjusted for the differences in baseline characteristics between participants treated with prasugrel vs. clopidogrel using propensity scoring.|||1.103|0.849|
72628795|NCT01088503|144785218|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.05|||||TWO_SIDED||||||||Odds Ratio for selection of Prasugrel for participants who had pre-procedure hemoglobin evaluation vs no hemoglobin evaluation.|||||
72628796|NCT01088503|144785219|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.005|||||TWO_SIDED||||||||Odds Ratio for selection of Prasugrel for participants with Duke CAD Index vs no Duke CAD Index.|||||
72410676|NCT03779841|144329759|SUPERIORITY||Risk Ratio (RR)|1.07||||0.6694|TWO_SIDED|95.0|0.8|1.43|||Cochran-Mantel-Haenszel|||P-values and Risk Ratios (and their corresponding 95% CI) for each pairwise comparison of AGN-151607 versus Placebo are obtained from Cochran-Mantel-Haenszel (CMH) test controlling for type of surgery (presence or absence of valve surgery) and age group (\< 65 or ≥ 65 years).||1.43|0.80|0.6694
72628797|NCT00186628|144785227|SUPERIORITY_OR_OTHER|||||||0.07|TWO_SIDED||||||Log Rank|||||||.07
72628798|NCT02581891|144785230|NON_INFERIORITY|The non-inferiority margin is set to 5 letters.|LS mean difference|-2.0199|STANDARD_ERROR_OF_MEAN|1.3833||0.0162|TWO_SIDED|95.0|-4.747|0.7073|||ANCOVA|||||0.7073|-4.7470|0.0162
72628799|NCT01076010|144785252|OTHER||25% Quartile (months)|8.0|||||TWO_SIDED|95.0|4.4|12.9||||||||12.9|4.4|
72628800|NCT01076010|144785252|OTHER||50% Quartile (months)|15.2|||||TWO_SIDED|95.0|11.1||DR was only summarized for subjects who had an objective tumor response. Upper limit of confidence interval could not be determined.||||||||11.1|
72628801|NCT01076010|144785252|OTHER||25% Quartile (months)|12.9|||||TWO_SIDED|95.0|5.6||DR was only summarized for subjects who had an objective tumor response. Upper limit of confidence interval could not be determined.||||||||5.6|
72628802|NCT01076010|144785253|OTHER||25% Quartile (months)|3.6|||||TWO_SIDED|95.0|1.9|5.2||||||||5.2|1.9|
72542909|NCT02570165|144615850|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|182.2|||||TWO_SIDED|95.0|99.8|264.6|||||The 95% confidence interval for the difference between 37.5 µg Batefenterol and Placebo was estimated.|||264.60|99.80|
72628803|NCT01076010|144785253|OTHER||50% Quartile (months)|11.0|||||TWO_SIDED|95.0|7.3|12.7||||||||12.7|7.3|
72628804|NCT01076010|144785253|OTHER||75% Quartile (months)|20.9|||||TWO_SIDED|95.0|16.5||For the subjects in each treatment arm, PFS is calculated from the first dose date of the respective study drugs. Upper limit of confidence interval could not be determined.||||||||16.5|
72628805|NCT01076010|144785253|OTHER||25% Quartile (months)|7.2|||||TWO_SIDED|95.0|3.5|9.2||||||||9.2|3.5|
72628806|NCT01076010|144785254|OTHER||25% Quartile (months)|8.2|||||TWO_SIDED|95.0|6.0|12.1||||||||12.1|6.0|
72542910|NCT02570165|144615850|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|196.6|||||TWO_SIDED|95.0|128.4|264.8|||||The 95% confidence interval for the difference between 75 µg Batefenterol and Placebo was estimated.|||264.80|128.40|
72542911|NCT02570165|144615850|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|204.6|||||TWO_SIDED|95.0|137.2|272.1|||||The 95% confidence interval for the difference between 150 µg Batefenterol and Placebo was estimated.|||272.10|137.20|
72542912|NCT02570165|144615850|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|208.9|||||TWO_SIDED|95.0|138.7|279.2|||||The 95% confidence interval for the difference between 300 µg Batefenterol and Placebo was estimated.|||279.20|138.70|
72542913|NCT02570165|144615850|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|211.1|||||TWO_SIDED|95.0|138.6|283.7|||||The 95% confidence interval for the difference between 600 µg Batefenterol and Placebo was estimated.|||283.70|138.60|
72542914|NCT00362401|144615864|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||ANOVA|||The comparison of the three valve groups with respect to the objective sound measures was made by the one-way ANOVA method. The null hypothesis is that there is no difference on intensity of heart valve sounds among the three groups.||||<0.05
72542915|NCT03182686|144615885|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||"H0:π ≤ π0 versus HA:π \> π0~Where π0 is the hypothesized clinically significant value for the proportion of responders. The value will be 30% in this study. This test will be tested using an exact binomial test. That is, given the sample size of n, the number of responders X, and the value of π0 =0.30, then probability that X or more events would be observed will be calculated as the p-value. Since this is a one-sided test, the alpha level will be 0.025."||||<0.0001
72628807|NCT01076010|144785254|OTHER||50% Quartile (months)|21.6|||||TWO_SIDED|95.0|17.0|27.6||||||||27.6|17.0|
72628808|NCT01076010|144785254|OTHER||75% Quartile (months)|30.7|||||TWO_SIDED|95.0|28.8||For the subjects in each treatment arm, OS is calculated from the first dose date of the respective study drugs. Upper limit of confidence interval could not be determined.||||||||28.8|
72628809|NCT03767881|144785263|NON_INFERIORITY|The upper limit of a 97.8% confidence limit of the mean days to resolution of acute cholecystitis is compared to a Performance Goal of 3.5 days.|Mean Difference (Final Values)|3.5|||||ONE_SIDED|97.8||10.78|||t-test, 1 sided|||||10.78||
72628810|NCT03767881|144785264|NON_INFERIORITY|The upper limit of a 99.7% confidence limit of the proportion of patients with reintervention, including migration and occlusion, is compared to a Performance Goal of 46.2%.|Performance Goal|16.7|||||ONE_SIDED|99.7||42.0|||1-sided Clopper-Pearson 99.7% CI|||||42.0||
72628811|NCT03498716|144785301|SUPERIORITY|Stratified Analysis: The stratification factors used in the analysis are axillary nodal status, surgery (breast conserving vs. mastectomy),and tumor PD-L1 status.|Hazard Ratio (HR)|1.11||||0.3846|TWO_SIDED|95.0|0.87|1.42|||Log Rank|||||1.42|0.87|0.3846
72628812|NCT00265850|144785315|SUPERIORITY||Hazard Ratio (HR)|0.88||||0.08|TWO_SIDED|95.0|0.77|1.01|||Log Rank|||||1.01|0.77|0.08
72628813|NCT00265850|144785316|SUPERIORITY||Hazard Ratio (HR)|0.95||||0.45|TWO_SIDED|95.0|0.84|1.08|||Log Rank|||||1.08|0.84|0.45
72577427|NCT00863772|144681684|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.13|STANDARD_ERROR_OF_MEAN|0.37||0.72|TWO_SIDED|95.0|-0.59|0.86|||ANCOVA|||Analysis of co-variance (ANCOVA) model was used with treatment as main effect, baseline value as a covariate, and study site as a random effect.||0.86|-0.59|0.720
72577428|NCT00863772|144681684|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.37||0.985|TWO_SIDED|95.0|-0.73|0.74|||ANCOVA|||ANCOVA model was used with treatment as main effect, baseline value as a covariate, and study site as a random effect.||0.74|-0.73|0.985
72577429|NCT01307748|144681768|OTHER|||||||0.005||||||The p value was adjusted for multiple comparisons using false discovery rate.|ANCOVA|Repeated-measures ANOVA with time (stress, post-stress) as a within factor and aroma (lavender, coconut, water) as a between-group factor was used.||The null hypothesis stated that there were no differences between the groups in cortisol level trajectory over time.||||.005
72577430|NCT01307748|144681770|OTHER|||||||0.01||||||P value was adjusted for multiple comparisons using false discovery rate|ANCOVA|A 3 (lavender, coconut, water) by 2 ( prime, no prime) Analysis of Covariance (ANCOVA), with years of education as a covariate was used.||||||.01
72577431|NCT00315731|144681780|NON_INFERIORITY_OR_EQUIVALENCE|Comparability of AUC values after dosimetric dose of fission-derived 131I-tositumomab with historical data from tellurium-derived 131I-tositumomab|Ratio of AUC(0-120)|0.97|||||TWO_SIDED|90.0|0.85|1.12|||||Ratio of AUC(0-120) is the ratio of AUC(0-120) values following infusion of fission-derived 131I-tositumomab to those following infusion of tellurium-derived 131I-tositumomab.|||1.12|0.85|
72577432|NCT00315731|144681781|NON_INFERIORITY_OR_EQUIVALENCE|Comparability of AUC values after dosimetric dose of fission-derived 131I-tositumomab with historical data from tellurium-derived 131I-tositumomab|Ratio of AUC(0-168)|0.96|||||TWO_SIDED|90.0|0.83|1.11|||||Ratio of AUC(0-168) is the ratio of AUC(0-168) values following infusion of fission-derived 131I-tositumomab to those following infusion of tellurium-derived 131I-tositumomab.|||1.11|0.83|
72577433|NCT00315731|144681782|NON_INFERIORITY_OR_EQUIVALENCE|Comparability of AUC values after dosimetric dose of fission-derived 131I-tositumomab with historical data from tellurium-derived 131I-tositumomab|Ratio of AUC(0 to infinity)|0.93|||||TWO_SIDED|90.0|0.78|1.1||||||||1.10|0.78|
72577434|NCT00315731|144681783|NON_INFERIORITY_OR_EQUIVALENCE|Comparability of AUC values after dosimetric dose of fission-derived 131I-tositumomab with historical data from tellurium-derived 131I-tositumomab|Ratio of Cmax|0.98|||||TWO_SIDED|90.0|0.87|1.11||||||||1.11|0.87|
72577435|NCT04614246|144681791|OTHER||LS-Mean|-1.63|STANDARD_ERROR_OF_MEAN|0.38|||TWO_SIDED|80.0|-2.13|-1.14|||Mixed Models Analysis|||80% confidence interval (CI) for change in mean worst EAPP from baseline to Week 12||-1.14|-2.13|
72577436|NCT04614246|144681791|OTHER||LS-Mean|-2.13|STANDARD_ERROR_OF_MEAN|0.41|||TWO_SIDED|80.0|-2.66|-1.61|||Mixed Models Analysis|||80% confidence interval (CI) for change in mean worst EAPP from baseline to Week 12||-1.61|-2.66|
72577437|NCT04614246|144681791|OTHER||LS-Mean|-1.96|STANDARD_ERROR_OF_MEAN|0.41|||TWO_SIDED|80.0|-2.48|-1.43|||Mixed Models Analysis|||80% confidence interval (CI) for change in mean worst EAPP from baseline to Week 12||-1.43|-2.48|
72577438|NCT04614246|144681791|OTHER||LS-Mean|-1.94|STANDARD_ERROR_OF_MEAN|0.38|||TWO_SIDED|80.0|-2.44|-1.45|||Mixed Models Analysis|||80% confidence interval (CI) for change in mean worst EAPP from baseline to Week 12||-1.45|-2.44|
72577439|NCT04614246|144681792|OTHER|mixed model repeated measures|Difference of least square-mean|0.29|STANDARD_ERROR_OF_MEAN|0.54|||TWO_SIDED|95.0|-0.77|1.35||||||Difference of least square-mean (95% Confidence Interval, CI) - Eliapixant arms vs Placebo arm (pairwise comparison) - change in mean worst EAPP from baseline to Week 12 - pPPS||1.35|-0.77|
72577440|NCT04614246|144681792|OTHER|mixed model repeated measures (MMRM)|Difference of least square-mean|-0.18|STANDARD_ERROR_OF_MEAN|0.55|||TWO_SIDED|95.0|-1.27|0.91||||||Difference of least square-mean (95% Confidence Interval, CI) - Eliapixant arms vs Placebo arm (pairwise comparison) - change in mean worst EAPP from baseline to Week 12 - pPPS||0.91|-1.27|
72577441|NCT04614246|144681792|OTHER|mixed model repeated measures (MMRM)|Difference of least square-mean|-0.08|STANDARD_ERROR_OF_MEAN|0.56|||TWO_SIDED|98.0|-1.17|1.02||||||Difference of least square-mean (95% Confidence Interval, CI) - Eliapixant arms vs Placebo arm (pairwise comparison) - change in mean worst EAPP from baseline to Week 12 - pPPS||1.02|-1.17|
72577442|NCT04614246|144681792|OTHER|mixed model repeated measures (MMRM)|Difference of least square-mean|0.29|STANDARD_ERROR_OF_MEAN|0.54|||TWO_SIDED|80.0|-0.4|0.98||||||Difference of least square-mean (80% Confidence Interval, CI) - Eliapixant arms vs Placebo arm (pairwise comparison) - change in mean worst EAPP from baseline to Week 12 - pPPS||0.98|-0.4|
72577443|NCT04614246|144681792|OTHER|mixed model repeated measures (MMRM)|Difference of least square-mean|-0.18|STANDARD_ERROR_OF_MEAN|0.55|||TWO_SIDED|80.0|-0.89|0.53||||||Difference of least square-mean (80% Confidence Interval, CI) - Eliapixant arms vs Placebo arm (pairwise comparison) - change in mean worst EAPP from baseline to Week 12 - pPPS||0.53|-0.89|
72577444|NCT04614246|144681792|OTHER|mixed model repeated measures (MMRM)|Difference of least square-mean|-0.08|STANDARD_ERROR_OF_MEAN|0.56|||TWO_SIDED|80.0|-0.79|0.64||||||Difference of least square-mean (80% Confidence Interval, CI) - Eliapixant arms vs Placebo arm (pairwise comparison) - change in mean worst EAPP from baseline to Week 12 - pPPS||0.64|-0.79|
72577445|NCT02207634|144681848|NON_INFERIORITY|The non-inferiority margin was 0.19, calculated as 20% of the observed common standard deviation, which was estimated from observations in the placebo group by a repeated measured mixed-effect linear model with visit as a covariate. If the upper bound of the 95% CI for the difference between the placebo and evolocumab group in mean change from baseline for Z score averaged across the visits was less than the non-inferiority margin non-inferiority criteria were met.|Treatment Difference|0.0072|STANDARD_ERROR_OF_MEAN|0.0375|||TWO_SIDED|95.0|-0.0664|0.0808||||||A repeated measures mixed-effect linear model was used to estimate treatment difference (placebo - evolocumab) in change from baseline and associated 95% confidence intervals (CI). The model included stratification factors for Study 20110118 (final screening low-density lipoprotein cholesterol \[LDL-C\] and geographical region), age, education level, baseline SWM strategy index Z score, treatment group, visit, and treatment by visit interaction.||0.0808|-0.0664|
72577446|NCT02207634|144681849|OTHER||Treatment Difference|0.0333|STANDARD_ERROR_OF_MEAN|0.0363|||TWO_SIDED|95.0|-0.0378|0.1045||||||A repeated measures mixed-effect linear model was used to estimate treatment difference (placebo - evolocumab) in change from baseline and associated 95% confidence intervals (CI). The model included stratification factors for Study 20110118 (final screening LDL-C and geographical region), age, education level, baseline SWM between-errors Z score, treatment group, visit, and treatment by visit interaction.||0.1045|-0.0378|
72577447|NCT02207634|144681850|OTHER||Treatment Difference|0.0226|STANDARD_ERROR_OF_MEAN|0.033|||TWO_SIDED|95.0|-0.0422|0.0873||||||A repeated measures mixed-effect linear model was used to estimate treatment difference (placebo - evolocumab) in change from baseline and associated 95% confidence intervals (CI). The model included stratification factors for Study 20110118 (final screening LDL-C and geographical region), age, education level, baseline PAL total errors adjusted Z score, treatment group, visit, and treatment by visit interaction.||0.0873|-0.0422|
72577448|NCT02207634|144681851|OTHER||Treatment Difference|0.0727|STANDARD_ERROR_OF_MEAN|0.0382|||TWO_SIDED|95.0|-0.0022|0.1477||||||A repeated measures mixed-effect linear model was used to estimate treatment difference ( placebo - evolocumab) in change from baseline and associated 95% confidence intervals (CI). The model included stratification factors for Study 20110118 (final screening LDL-C and geographical region), age, education level, baseline RTI median 5-choice reaction time Z score, treatment group, visit, and treatment by visit interaction.||0.1477|-0.0022|
72628814|NCT01657305|144785323|SUPERIORITY_OR_OTHER||||||<|0.0001||||||2-sided, significance level = 0.05|t-test, 2 sided|||"All participants received both treatments and treatments were intra-individually compared.~Hypotheses tested: H0: δ = 0 and H1: δ ≠ 0 with δ being the difference in time to wound closure between treatments.~Negative values for the intra-individual time difference indicate faster healing of the Oleogel-S10-treated wound half.~For right-censored observations (no wound closure observed in blinded photo evaluation), wound closure was conservatively calculated as +1 day after the last photo."||||<0.0001
72628815|NCT01657305|144785327|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.6|STANDARD_DEVIATION|13.4|<|0.0001|TWO_SIDED|95.0|6.0|11.2||Day 7|t-test, 2 sided||Difference in degree of epithelialization \[%\] (Oleogel-S10 minus standard of care)|||11.2|6.0|<0.0001
72628816|NCT01657305|144785327|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.1|STANDARD_DEVIATION|17.0|<|0.0001|TWO_SIDED|95.0|6.9|13.4||Day 10|t-test, 2 sided||Difference in degree of epithelialization \[%\] (Oleogel-S10 minus standard of care)|||13.4|6.9|<0.0001
72628817|NCT01657305|144785327|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.9|STANDARD_DEVIATION|17.0|<|0.0001|TWO_SIDED|95.0|4.6|11.1||Day 14|t-test, 2 sided||Difference in degree of epithelialization \[%\] (Oleogel-S10 minus standard of care)|||11.1|4.6|<0.0001
72628818|NCT01657305|144785327|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.4|STANDARD_DEVIATION|18.3|<|0.0001|TWO_SIDED|95.0|3.9|10.9||Day 18|t-test, 2 sided||Difference in degree of epithelialization \[%\] (Oleogel-S10 minus standard of care)|||10.9|3.9|<0.0001
72577449|NCT00591773|144681862|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.86|||<|0.001|TWO_SIDED|95.0|-18.54|-13.19||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented. Overall 0.05 level of significance for multiple comparisons controlled using closed testing procedure.|ANCOVA|||||-13.19|-18.54|<0.001
72577450|NCT00591773|144681862|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.45|||<|0.001|TWO_SIDED|95.0|-18.13|-12.76||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented. Overall 0.05 level of significance for multiple comparisons controlled using closed testing procedure.|ANCOVA|||||-12.76|-18.13|<0.001
72577451|NCT00591773|144681863|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.4|||<|0.001|TWO_SIDED|95.0|-17.81|-10.99||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented. Overall 0.05 level of significance for multiple comparisons controlled using closed testing procedure.|ANCOVA|||||-10.99|-17.81|<0.001
72577452|NCT00591773|144681863|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.68|||<|0.001|TWO_SIDED|95.0|-16.1|-9.25||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented. Overall 0.05 level of significance for multiple comparisons controlled using closed testing procedure.|ANCOVA|||||-9.25|-16.10|<0.001
72577453|NCT00591773|144681864|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.29|||<|0.001|TWO_SIDED|95.0|-12.02|-8.56||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-8.56|-12.02|<0.001
72577454|NCT00591773|144681864|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.49|||<|0.001|TWO_SIDED|95.0|-12.23|-8.76||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-8.76|-12.23|<0.001
72577455|NCT00591773|144681865|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.25|||<|0.001|TWO_SIDED|95.0|-9.25|-5.25||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-5.25|-9.25|<0.001
72577456|NCT00591773|144681865|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.05|||<|0.001|TWO_SIDED|95.0|-9.06|-5.05||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-5.05|-9.06|<0.001
72577457|NCT00591773|144681866|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.8|||<|0.001|TWO_SIDED|95.0|-19.56|-14.04||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-14.04|-19.56|<0.001
72577458|NCT00591773|144681866|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.24|||<|0.001|TWO_SIDED|95.0|-19.01|-13.47||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-13.47|-19.01|<0.001
72577459|NCT00591773|144681867|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.02|||<|0.001|TWO_SIDED|95.0|-12.86|-9.18||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-9.18|-12.86|<0.001
72577460|NCT00591773|144681867|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.2|||<|0.001|TWO_SIDED|95.0|-13.04|-9.35||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-9.35|-13.04|<0.001
72628819|NCT01657305|144785327|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.4|STANDARD_DEVIATION|14.1|<|0.0001|TWO_SIDED|95.0|3.7|9.1||Day 21|t-test, 2 sided||Difference in degree of epithelialization \[%\] (Oleogel-S10 minus standard of care)|||9.1|3.7|<0.0001
72628820|NCT01657305|144785327|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.9|STANDARD_DEVIATION|12.9|=|0.0021|TWO_SIDED|95.0|1.5|6.4||Day 28|t-test, 2 sided||Difference in degree of epithelialization \[%\] (Oleogel-S10 minus standard of care)|||6.4|1.5|=0.0021
72577461|NCT00591773|144681868|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.93|||<|0.001|TWO_SIDED|95.0|-15.92|-9.94||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-9.94|-15.92|<0.001
72577462|NCT00591773|144681868|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.84|||<|0.001|TWO_SIDED|95.0|-15.83|-9.84||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-9.84|-15.83|<0.001
72577463|NCT00591773|144681869|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.16|||<|0.001|TWO_SIDED|95.0|-10.14|-6.19||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-6.19|-10.14|<0.001
72577464|NCT00591773|144681869|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.17|||<|0.001|TWO_SIDED|95.0|-10.15|-6.19||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-6.19|-10.15|<0.001
72577465|NCT00591773|144681870|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.52|||<|0.001|TWO_SIDED|95.0|-20.39|-14.64||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-14.64|-20.39|<0.001
72577466|NCT00591773|144681870|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.95|||<|0.001|TWO_SIDED|95.0|-19.84|-14.05||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-14.05|-19.84|<0.001
72577467|NCT00591773|144681871|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.54|||<|0.001|TWO_SIDED|95.0|-13.49|-9.59||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-9.59|-13.49|<0.001
72577468|NCT00591773|144681871|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.68|||<|0.001|TWO_SIDED|95.0|-13.64|-9.72||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-9.72|-13.64|<0.001
72628821|NCT01180127|144785349|SUPERIORITY_OR_OTHER|||||||0.0001|TWO_SIDED||||||Repeated measures ANOVA|||Repeated measures ANOVA for the interaction of time (baseline vs 12 week) and flavanol group.||||.0001
72410677|NCT03779841|144329760|SUPERIORITY||Risk Ratio (RR)|0.81||||0.2578|TWO_SIDED|95.0|0.55|1.18|||Cochran-Mantel-Haenszel|||P-values and Risk Ratios (and their corresponding 95% CI) for each pairwise comparison of AGN-151607 versus Placebo are obtained from Cochran-Mantel-Haenszel (CMH) test controlling for type of surgery (presence or absence of valve surgery) and age group (\< 65 or ≥ 65 years).||1.18|0.55|0.2578
72542916|NCT00529568|144615931|SUPERIORITY_OR_OTHER||Percentage difference in SVR|6.0||||0.0202|TWO_SIDED|95.0|1.2|10.9||Stratified Cochran-Mantel-Haenszel (CMH) chi-square test adjusted for the randomization strata|Cochran-Mantel-Haenszel||The estimated value reflects the percentage of participants with SVR in the eltrombopag group minus the percentage of participants with SVR in the placebo group. Adjusted for the actual strata: HCV genotype, baseline platelet count, and HCV RNA.|||10.9|1.2|0.0202
72542917|NCT00931385|144615965|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.148|STANDARD_ERROR_OF_MEAN|0.018|<|0.0001||95.0|0.113|0.183|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Olo 5 mcg qd minus Placebo|||0.183|0.113|<0.0001
72542918|NCT00931385|144615965|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.148|STANDARD_ERROR_OF_MEAN|0.018|<|0.0001||95.0|0.113|0.183|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Olo 10 mcg qd minus Placebo|||0.183|0.113|<0.0001
72542919|NCT00931385|144615965|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.141|STANDARD_ERROR_OF_MEAN|0.018|<|0.0001||95.0|0.106|0.177|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Form 12 mcg bid minus Placebo|||0.177|0.106|<0.0001
72542920|NCT00931385|144615966|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.109|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.073|0.146|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Olo 5 mcg qd minus Placebo|||0.146|0.073|<0.0001
72542921|NCT00931385|144615966|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.127|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.091|0.164|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Olo 10 mcg qd minus Placebo|||0.164|0.091|<0.0001
72542922|NCT00931385|144615966|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.172|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.135|0.209|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Form 12 mcg bid minus Placebo|||0.209|0.135|<0.0001
72542923|NCT00931385|144615967|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.128|STANDARD_ERROR_OF_MEAN|0.017|<|0.0001||95.0|0.094|0.163|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Olo 5 mcg qd minus Placebo|||0.163|0.094|<0.0001
72542924|NCT00931385|144615967|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.137|STANDARD_ERROR_OF_MEAN|0.017|<|0.0001||95.0|0.103|0.172|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Olo 10 mcg qd minus Placebo|||0.172|0.103|<0.0001
72542925|NCT00931385|144615967|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.156|STANDARD_ERROR_OF_MEAN|0.018|<|0.0001||95.0|0.122|0.191|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Form 12 mcg bid minus Placebo|||0.191|0.122|<0.0001
72410678|NCT03779841|144329760|SUPERIORITY||Risk Ratio (RR)|1.05||||0.7526|TWO_SIDED|95.0|0.76|1.47|||Cochran-Mantel-Haenszel|||P-values and Risk Ratios (and their corresponding 95% CI) for each pairwise comparison of AGN-151607 versus Placebo are obtained from Cochran-Mantel-Haenszel (CMH) test controlling for type of surgery (presence or absence of valve surgery) and age group (\< 65 or ≥ 65 years).||1.47|0.76|0.7526
72542926|NCT00931385|144615968|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.164|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.126|0.201|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Olo 5 mcg qd minus Placebo|||0.201|0.126|<0.0001
72542927|NCT00931385|144615968|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.164|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.127|0.202|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Olo 10 mcg qd minus Placebo|||0.202|0.127|<0.0001
72542928|NCT00931385|144615968|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.198|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.16|0.236|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Form 12 mcg bid minus Placebo|||0.236|0.160|<0.0001
72410679|NCT03779841|144329761|SUPERIORITY||Risk Ratio (RR)|0.8||||0.2549|TWO_SIDED|95.0|0.55|1.18|||Cochran-Mantel-Haenszel|||P-values and Risk Ratios (and their corresponding 95% CI) for each pairwise comparison of AGN-151607 versus Placebo are obtained from Cochran-Mantel-Haenszel (CMH) test controlling for type of surgery (presence or absence of valve surgery) and age group (\< 65 or ≥ 65 years).||1.18|0.55|0.2549
72542929|NCT00931385|144615969|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.174|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001||95.0|0.135|0.214|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Olo 5 mcg qd minus Placebo|||0.214|0.135|<0.0001
72542930|NCT00931385|144615969|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.166|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001||95.0|0.127|0.206|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Olo 10 mcg qd minus Placebo|||0.206|0.127|<0.0001
72542931|NCT00931385|144615969|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.218|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001||95.0|0.178|0.257|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Form 12 mcg bid minus Placebo|||0.257|0.178|<0.0001
72542932|NCT00931385|144615970|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.106|STANDARD_ERROR_OF_MEAN|0.021|<|0.0001||95.0|0.064|0.147|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Olo 5 mcg qd minus Placebo|||0.147|0.064|<0.0001
72628822|NCT01180127|144785350|SUPERIORITY_OR_OTHER|||||||0.038|TWO_SIDED|||||The ANCOVA model included a main effect for both flavanol and exercise, so this p-value is for the effect of flavanol on Modbent controlling for baseline Modbent and exercise|ANCOVA|||ANCOVA used to test main effect of flavanol||||0.038
72628823|NCT01180127|144785350|SUPERIORITY_OR_OTHER|||||||0.815|TWO_SIDED|||||The ANCOVA included both a main effect for flavanol and exercise, so this p-value is for the test of exercise controlling for baseline Modbent and flavanol|ANCOVA|||ANCOVA used to test main effect of exercise||||0.815
72628824|NCT01180127|144785351|SUPERIORITY_OR_OTHER|||||||0.853|TWO_SIDED||||||ANCOVA|||ANCOVA for testing main effect of flavanol||||0.853
72628825|NCT01180127|144785351|SUPERIORITY_OR_OTHER|||||||0.581|TWO_SIDED||||||ANCOVA|||ANCOVA for testing main effect of exercise||||0.581
72410680|NCT03779841|144329761|SUPERIORITY||Risk Ratio (RR)|1.03||||0.8544|TWO_SIDED|95.0|0.73|1.45|||Cochran-Mantel-Haenszel|||P-values and Risk Ratios (and their corresponding 95% CI) for each pairwise comparison of AGN-151607 versus Placebo are obtained from Cochran-Mantel-Haenszel (CMH) test controlling for type of surgery (presence or absence of valve surgery) and age group (\< 65 or ≥ 65 years).||1.45|0.73|0.8544
72628826|NCT01180127|144785352|SUPERIORITY_OR_OTHER|||||||0.237|TWO_SIDED||||||ANCOVA|||ANCOVA was used to test for an exercise effect.||||0.237
72628827|NCT03821272|144785366|SUPERIORITY||non-recurrence rate|0.45||||0.31|TWO_SIDED|95.0|0.17|0.77|||Fisher Exact|||||0.77|0.17|0.31
72628828|NCT03821272|144785367|SUPERIORITY||non-recurrence rate|0.8||||0.31|TWO_SIDED|95.0|0.28|0.99|||Fisher Exact|||||0.99|0.28|0.31
72628829|NCT03821272|144785368|SUPERIORITY||non-recurrence rate|0.56||||0.58|TWO_SIDED|95.0|0.21|0.86|||Fisher Exact|||||0.86|0.21|0.58
72410681|NCT03779841|144329762|SUPERIORITY||Risk Ratio (RR)|0.74||||0.1718|TWO_SIDED|95.0|0.48|1.14|||Cochran-Mantel-Haenszel|||P-values and Risk Ratios (and their corresponding 95% CI) for each pairwise comparison of AGN-151607 versus Placebo are obtained from Cochran-Mantel-Haenszel (CMH) test controlling for type of surgery (presence or absence of valve surgery) and age group (\< 65 or ≥ 65 years).||1.14|0.48|0.1718
72410682|NCT03779841|144329762|SUPERIORITY||Risk Ratio (RR)|0.83||||0.3801|TWO_SIDED|95.0|0.54|1.27|||Cochran-Mantel-Haenszel|||P-values and Risk Ratios (and their corresponding 95% CI) for each pairwise comparison of AGN-151607 versus Placebo are obtained from Cochran-Mantel-Haenszel (CMH) test controlling for type of surgery (presence or absence of valve surgery) and age group (\< 65 or ≥ 65 years).||1.27|0.54|0.3801
72410683|NCT03779841|144329763|SUPERIORITY||Risk Ratio (RR)|0.87||||0.5531|TWO_SIDED|95.0|0.54|1.39|||Cochran-Mantel-Haenszel|||P-values and Risk Ratios (and their corresponding 95% CI) for each pairwise comparison of AGN-151607 versus Placebo are obtained from Cochran-Mantel-Haenszel (CMH) test controlling for type of surgery (presence or absence of valve surgery) and age group (\< 65 or ≥ 65 years).||1.39|0.54|0.5531
72542933|NCT00931385|144615970|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.113|STANDARD_ERROR_OF_MEAN|0.021|<|0.0001||95.0|0.072|0.155|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Olo 10 mcg qd minus Placebo|||0.155|0.072|<0.0001
72542934|NCT00931385|144615970|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.133|STANDARD_ERROR_OF_MEAN|0.021|<|0.0001||95.0|0.092|0.175|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Form 12 mcg bid minus Placebo|||0.175|0.092|<0.0001
72542935|NCT00931385|144615971|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.226|STANDARD_ERROR_OF_MEAN|0.03|<|0.0001||95.0|0.167|0.284|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Olo 5 mcg qd minus Placebo|||0.284|0.167|<0.0001
72628830|NCT03821272|144785369|SUPERIORITY||non-recurrence rate|0.8||||0.58|TWO_SIDED|95.0|0.28|0.99|||Fisher Exact|||||0.99|0.28|0.58
72628831|NCT02255435|144785388|SUPERIORITY||LS Mean difference (Net)|0.1||||0.1524|TWO_SIDED|95.0|-0.04|0.23|||Mixed Models Analysis|Treatment group, time, and the interaction between treatment and time were used as fixed factors.|Difference is omaveloxolone - placebo|||0.23|-0.04|0.1524
72628832|NCT02255435|144785388|SUPERIORITY||LS Mean difference (Net)|0.03||||0.7086|TWO_SIDED|95.0|-0.11|0.16|||Mixed Models Analysis|Treatment group, time, and the interaction between treatment and time were used as fixed factors.|Difference is omaveloxolone - placebo|||0.16|-0.11|0.7086
72628833|NCT02255435|144785388|SUPERIORITY||LS Mean difference (Net)|-0.13||||0.0651|TWO_SIDED|95.0|-0.26|0.01|||Mixed Models Analysis|Treatment group, time, and the interaction between treatment and time were used as fixed factors.|Difference is omaveloxolone - placebo|||0.01|-0.26|0.0651
72329439|NCT03037476|144184381|OTHER|General Linear Model|Slope|-0.336||||0.465|TWO_SIDED|95.0|-1.238|0.566|||Mixed Models Analysis|Poisson Regression||Change in Medical Misuse of Prescription Stimulant Medication Among those with ADHD Diagnosis from Baseline to 12 Month Followup||.566|-1.238|.465
72628834|NCT02255435|144785388|SUPERIORITY||LS Mean difference (Net)|0.02||||0.7937|TWO_SIDED|95.0|-0.12|0.15|||Mixed Models Analysis|Treatment group, time, and the interaction between treatment and time were used as fixed factors.|Difference is omaveloxolone - placebo|||0.15|-0.12|0.7937
72628835|NCT02255435|144785388|SUPERIORITY||LS Mean difference (Net)|-0.04||||0.5587|TWO_SIDED|95.0|-0.18|0.1|||Mixed Models Analysis|Treatment group, time, and the interaction between treatment and time were used as fixed factors.|Difference is omaveloxolone - placebo|||0.10|-0.18|0.5587
72628836|NCT02255435|144785388|SUPERIORITY||LS Mean difference (Net)|-0.02||||0.7285|TWO_SIDED|95.0|-0.13|0.09|||Mixed Models Analysis|Treatment group, time, and the interaction between treatment and time were used as fixed factors.|Difference is omaveloxolone - placebo|||0.09|-0.13|0.7285
72628837|NCT02255435|144785388|SUPERIORITY||LS Mean difference (Net)|0.03||||0.5802|TWO_SIDED|95.0|-0.09|0.15|||Mixed Models Analysis|Treatment group, time, and the interaction between treatment and time were used as fixed factors.|Difference is omaveloxolone - placebo|||0.15|-0.09|0.5802
72628838|NCT02255435|144785388|SUPERIORITY||LS Mean difference (Net)|0.0||||0.9698|TWO_SIDED|95.0|-0.08|0.08|||Mixed Models Analysis|Treatment group, time, and the interaction between treatment and time were used as fixed factors.|Difference is omaveloxolone - placebo|Comparison of Omaveloxolone capsules pooled with Placebo capsules||0.08|-0.08|0.9698
72628839|NCT02255435|144785389|SUPERIORITY||LS Mean difference (Net)|-2.4|STANDARD_ERROR_OF_MEAN|0.956||0.0141|TWO_SIDED|95.0|-4.31|-0.5|||Mixed Models Analysis|Fixed factors: treatment group, time, interaction between treatment and time, interaction between baseline and time; covariates: site, baseline mFARS|Difference is omaveloxolone - placebo.|||-0.50|-4.31|0.0141
72410684|NCT03779841|144329763|SUPERIORITY||Risk Ratio (RR)|0.82||||0.4213|TWO_SIDED|95.0|0.51|1.33|||Cochran-Mantel-Haenszel|||P-values and Risk Ratios (and their corresponding 95% CI) for each pairwise comparison of AGN-151607 versus Placebo are obtained from Cochran-Mantel-Haenszel (CMH) test controlling for type of surgery (presence or absence of valve surgery) and age group (\< 65 or ≥ 65 years).||1.33|0.51|0.4213
72410685|NCT03779841|144329764|SUPERIORITY||Risk Ratio (RR)|0.92||||0.804|TWO_SIDED|95.0|0.49|1.73|||Cochran-Mantel-Haenszel|||P-values and Risk Ratios (and their corresponding 95% CI) for each pairwise comparison of AGN-151607 versus Placebo are obtained from Cochran-Mantel-Haenszel (CMH) test controlling for type of surgery (presence or absence of valve surgery) and age group (\< 65 or ≥ 65 years).||1.73|0.49|0.8040
72410686|NCT03779841|144329764|SUPERIORITY||Risk Ratio (RR)|1.1||||0.7573|TWO_SIDED|95.0|0.61|1.98|||Cochran-Mantel-Haenszel|||P-values and Risk Ratios (and their corresponding 95% CI) for each pairwise comparison of AGN-151607 versus Placebo are obtained from Cochran-Mantel-Haenszel (CMH) test controlling for type of surgery (presence or absence of valve surgery) and age group (\< 65 or ≥ 65 years).||1.98|0.61|0.7573
72410687|NCT03779841|144329765|SUPERIORITY||Risk Ratio (RR)|0.69||||0.4065|TWO_SIDED|95.0|0.28|1.67|||Cochran-Mantel-Haenszel|||P-values and Risk Ratios (and their corresponding 95% CI) for each pairwise comparison of AGN-151607 versus Placebo are obtained from Cochran-Mantel-Haenszel (CMH) test controlling for type of surgery (presence or absence of valve surgery) and age group (\< 65 or ≥ 65 years).||1.67|0.28|0.4065
72410688|NCT03779841|144329765|SUPERIORITY||Risk Ratio (RR)|1.28||||0.5257|TWO_SIDED|95.0|0.6|2.7|||Cochran-Mantel-Haenszel|||P-values and Risk Ratios (and their corresponding 95% CI) for each pairwise comparison of AGN-151607 versus Placebo are obtained from Cochran-Mantel-Haenszel (CMH) test controlling for type of surgery (presence or absence of valve surgery) and age group (\< 65 or ≥ 65 years).||2.70|0.60|0.5257
72577469|NCT00591773|144681872|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.04|||<|0.001|TWO_SIDED|95.0|-17.13|-10.94||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-10.94|-17.13|<0.001
72577470|NCT00591773|144681872|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.48|||<|0.001|TWO_SIDED|95.0|-16.58|-10.37||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-10.37|-16.58|<0.001
72577471|NCT00591773|144681873|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.42|||<|0.001|TWO_SIDED|95.0|-11.65|-7.2||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-7.20|-11.65|<0.001
72577472|NCT00591773|144681873|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.69|||<|0.001|TWO_SIDED|95.0|-11.92|-7.46||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-7.46|-11.92|<0.001
72577473|NCT00591773|144681874|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.09|||<|0.001|TWO_SIDED|95.0|2.38|7.03||P-value for response criteria for systolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value is presented.|Regression, Logistic|||||7.03|2.38|<0.001
72577474|NCT00591773|144681874|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.03|||<|0.001|TWO_SIDED|95.0|1.82|5.03||P-value for response criteria for systolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value is presented.|Regression, Logistic|||||5.03|1.82|<0.001
72577475|NCT00591773|144681875|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.72|||<|0.001|TWO_SIDED|95.0|1.9|7.27||P-value for response criteria for diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic diastolic blood pressure as a covariate. The unadjusted p-value is presented.|Regression, Logistic|||||7.27|1.90|<0.001
72410689|NCT03779841|144329766|SUPERIORITY||Risk Ratio (RR)|0.78||||0.1612|TWO_SIDED|95.0|0.55|1.11|||Cochran-Mantel-Haenszel|||P-values and Risk Ratios (and their corresponding 95% CI) for each pairwise comparison of AGN-151607 versus Placebo are obtained from Cochran-Mantel-Haenszel (CMH) test controlling for type of surgery (presence or absence of valve surgery) and age group (\< 65 or ≥ 65 years).||1.11|0.55|0.1612
72410690|NCT03779841|144329766|SUPERIORITY||Risk Ratio (RR)|1.0||||0.9966|TWO_SIDED|95.0|0.74|1.35|||Cochran-Mantel-Haenszel|||P-values and Risk Ratios (and their corresponding 95% CI) for each pairwise comparison of AGN-151607 versus Placebo are obtained from Cochran-Mantel-Haenszel (CMH) test controlling for type of surgery (presence or absence of valve surgery) and age group (\< 65 or ≥ 65 years).||1.35|0.74|0.9966
72577476|NCT00591773|144681875|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.7||||0.002|TWO_SIDED|95.0|1.46|5.0||P-value for response criteria for diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic diastolic blood pressure as a covariate. The unadjusted p-value is presented.|Regression, Logistic|||||5.00|1.46|0.002
72577477|NCT00591773|144681876|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.0|||<|0.001|TWO_SIDED|95.0|2.41|6.64||P-value for joint response criteria for systolic blood pressure and diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value is presented.|Regression, Logistic|||||6.64|2.41|<0.001
72577478|NCT00591773|144681876|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.96|||<|0.001|TWO_SIDED|95.0|1.83|4.79||P-value for joint response criteria for systolic blood pressure and diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value is presented.|Regression, Logistic|||||4.79|1.83|<0.001
72577479|NCT00459355|144681877|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||MANCOVA|||||||<0.0001
72577480|NCT00459355|144681878|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||MANCOVA|||||||<.0001
72577481|NCT00459355|144681879|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED||||||MANCOVA|||||||.002
72577482|NCT02135614|144681880|SUPERIORITY||Treatment difference|0.12||||0.46|TWO_SIDED|95.0|-0.2|0.43||P-value was calculated from the ANCOVA model including baseline values, Clinical Frailty Scale (CFS) score, and stratification factor as covariates.|ANCOVA|||||0.43|-0.20|0.46
72628840|NCT02255435|144785390|SUPERIORITY||LS Mean difference (Net)|-1.81||||0.231|TWO_SIDED|95.0|-4.8|1.18|||Mixed Models Analysis|Treatment group, time, and the interaction between treatment and time were used as fixed factors.|Difference is omaveloxolone - placebo.|||1.18|-4.80|0.2310
72410691|NCT03779841|144329767|SUPERIORITY||Risk Ratio (RR)|0.68||||0.3374|TWO_SIDED|95.0|0.3|1.52|||Cochran-Mantel-Haenszel|||P-values and Risk Ratios (and their corresponding 95% CI) for each pairwise comparison of AGN-151607 versus Placebo are obtained from Cochran-Mantel-Haenszel (CMH) test controlling for type of surgery (presence or absence of valve surgery) and age group (\< 65 or ≥ 65 years).||1.52|0.30|0.3374
72410692|NCT03779841|144329767|SUPERIORITY||Risk Ratio (RR)|1.23||||0.5403|TWO_SIDED|95.0|0.62|2.45|||Cochran-Mantel-Haenszel|||P-values and Risk Ratios (and their corresponding 95% CI) for each pairwise comparison of AGN-151607 versus Placebo are obtained from Cochran-Mantel-Haenszel (CMH) test controlling for type of surgery (presence or absence of valve surgery) and age group (\< 65 or ≥ 65 years).||2.45|0.62|0.5403
72410693|NCT03779841|144329768|SUPERIORITY||Risk Ratio (RR)|3.94||||0.0163|TWO_SIDED|95.0|1.16|13.42|||Cochran-Mantel-Haenszel|||P-values and Risk Ratios (and their corresponding 95% CI) for each pairwise comparison of AGN-151607 versus Placebo are obtained from Cochran-Mantel-Haenszel (CMH) test controlling for type of surgery (presence or absence of valve surgery) and age group (\< 65 or ≥ 65 years).||13.42|1.16|0.0163
72410694|NCT03779841|144329768|SUPERIORITY||Risk Ratio (RR)|2.7||||0.1101|TWO_SIDED|95.0|0.76|9.64|||Cochran-Mantel-Haenszel|||P-values and Risk Ratios (and their corresponding 95% CI) for each pairwise comparison of AGN-151607 versus Placebo are obtained from Cochran-Mantel-Haenszel (CMH) test controlling for type of surgery (presence or absence of valve surgery) and age group (\< 65 or ≥ 65 years).||9.64|0.76|0.1101
72410695|NCT03779841|144329769|SUPERIORITY||Risk Ratio (RR)|0.86||||0.3339|TWO_SIDED|95.0|0.64|1.16|||Cochran-Mantel-Haenszel|||P-values and Risk Ratios (and their corresponding 95% CI) for each pairwise comparison of AGN-151607 versus Placebo are obtained from Cochran-Mantel-Haenszel (CMH) test controlling for type of surgery (presence or absence of valve surgery) and age group (\< 65 or ≥ 65 years).||1.16|0.64|0.3339
72410696|NCT03779841|144329769|SUPERIORITY||Risk Ratio (RR)|1.1||||0.4614|TWO_SIDED|95.0|0.85|1.42|||Cochran-Mantel-Haenszel|||P-values and Risk Ratios (and their corresponding 95% CI) for each pairwise comparison of AGN-151607 versus Placebo are obtained from Cochran-Mantel-Haenszel (CMH) test controlling for type of surgery (presence or absence of valve surgery) and age group (\< 65 or ≥ 65 years).||1.42|0.85|0.4614
72410697|NCT03483623|144329803|SUPERIORITY|||||||0.0001||||||Statistical analysis applies to all combinations-NATO WELP, NATO FIS, RAVEN WELP, RAVEN FIS|ANOVA|||Statistical analysis applies to all combinations-NATO WELP, NATO FIS, RAVEN WELP, RAVEN FIS||||0.0001
72410698|NCT03483623|144329804|SUPERIORITY|||||||0.0001||||||Statistical analysis applies to all combinations-NATO WELP, NATO FIS, RAVEN WELP, RAVEN FIS|ANOVA|||Statistical analysis applies to all combinations-NATO WELP, NATO FIS, RAVEN WELP, RAVEN FIS||||0.0001
72410699|NCT03483623|144329805|SUPERIORITY|||||||0.0001||||||Statistical analysis applies to all combinations-NATO WELP, NATO FIS, RAVEN WELP, RAVEN FIS|ANOVA|||Statistical analysis applies to all combinations-NATO WELP, NATO FIS, RAVEN WELP, RAVEN FIS||||0.0001
72410700|NCT03483623|144329806|SUPERIORITY|||||||0.0001||||||Statistical analysis applies to all combinations-NATO WELP, NATO FIS, RAVEN WELP, RAVEN FIS|ANOVA|||Statistical analysis applies to all combinations-NATO WELP, NATO FIS, RAVEN WELP, RAVEN FIS||||0.0001
72410701|NCT03483623|144329807|SUPERIORITY|||||||0.0001||||||Statistical analysis applies to all combinations-NATO WELP, NATO FIS, RAVEN WELP, RAVEN FIS|ANOVA|||Statistical analysis applies to all combinations-NATO WELP, NATO FIS, RAVEN WELP, RAVEN FIS||||0.0001
72410702|NCT03483623|144329808|SUPERIORITY|||||||0.0001||||||Statistical analysis applies to all combinations-NATO WELP, NATO FIS, RAVEN WELP, RAVEN FIS|ANOVA|||Statistical analysis applies to all combinations-NATO WELP, NATO FIS, RAVEN WELP, RAVEN FIS||||0.0001
72410703|NCT03483623|144329809|SUPERIORITY|||||||0.0001||||||Statistical analysis applies to all combinations-NATO WELP, NATO FIS, RAVEN WELP, RAVEN FIS|ANOVA|||Statistical analysis applies to all combinations-NATO WELP, NATO FIS, RAVEN WELP, RAVEN FIS||||0.0001
72410704|NCT03483623|144329810|SUPERIORITY|||||||0.0001||||||Statistical analysis applies to all combinations-NATO WELP, NATO FIS, RAVEN WELP, RAVEN FIS|ANOVA|||Statistical analysis applies to all combinations-NATO WELP, NATO FIS, RAVEN WELP, RAVEN FIS||||0.0001
72410705|NCT05955560|144329841|SUPERIORITY|||||||0.04||||||A two-sided paired t-test was used and p-value derived. The threshold for statistical significance was p \< 0.05|t-test, 2 sided|||||||0.04
72410706|NCT04621500|144329846|OTHER|The sequencing transcriptional profile cannot be analyzed by a statistical method.|||||||||||||||||In this open label study, the RNA sequencing transcription analysis was performed to assess if the transcriptome would be modified by vitamin D supplementation and it uniformaly was.|||
72410707|NCT01040871|144329866|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.038||||0.915|TWO_SIDED|95.0|0.529|2.037|||Cochran-Mantel-Haenszel|Stratified by IPI score|Odds ratio: VR-CAP CR rate relative to R-CHOP CR rate|||2.037|0.529|0.915
72542936|NCT00931385|144615971|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.229|STANDARD_ERROR_OF_MEAN|0.03|<|0.0001||95.0|0.17|0.287|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Olo 10 mcg qd minus Placebo|||0.287|0.170|<0.0001
72628841|NCT02255435|144785390|SUPERIORITY||LS Mean difference (Net)|-0.52||||0.7298|TWO_SIDED|95.0|-3.51|2.47|||Mixed Models Analysis|Treatment group, time, and the interaction between treatment and time were used as fixed factors.|Difference is omaveloxolone - placebo.|||2.47|-3.51|0.7298
72410708|NCT02451748|144329874|EQUIVALENCE|ANOVA||||||0.5378||||||Tukey adjustment for multiple comparisons|ANOVA|A priori threshold was \<0.05.||The mean mRNA expression for IL-7 was compared between all three visits simultaneously in RA Peripheral Blood Nonnuclear Cells. The comparison between the first and second visit is as follows.||||0.5378
72410709|NCT02451748|144329874|EQUIVALENCE|ANOVA||||||0.919||||||Tukey adjustment for multiple comparisons|ANOVA|A priori threshold was \<0.05.||The mean mRNA expression for IL-7 was compared between all three visits simultaneously in RA Peripheral Blood Nonnuclear Cells. The comparison between the first and third visit is as follows.||||0.919
72628842|NCT02255435|144785390|SUPERIORITY||LS Mean difference (Net)|-0.99||||0.5102|TWO_SIDED|95.0|-3.99|2.0|||Mixed Models Analysis|Treatment group, time, and the interaction between treatment and time were used as fixed factors.|Difference is omaveloxolone - placebo.|||2.00|-3.99|0.5102
72628843|NCT02255435|144785390|SUPERIORITY||LS Mean difference (Net)|-0.95||||0.5281|TWO_SIDED|95.0|-3.94|2.04|||Mixed Models Analysis|Treatment group, time, and the interaction between treatment and time were used as fixed factors.|Difference is omaveloxolone - placebo.|||2.04|-3.94|0.5281
72628844|NCT02255435|144785390|SUPERIORITY||LS Mean difference (Net)|-1.42||||0.3458|TWO_SIDED|95.0|-4.42|1.57|||Mixed Models Analysis|Treatment group, time, and the interaction between treatment and time were used as fixed factors.|Difference is omaveloxolone - placebo.|||1.57|-4.42|0.3458
72628845|NCT02255435|144785390|SUPERIORITY||LS Mean difference (Net)|-2.3||||0.0587|TWO_SIDED|95.0|-4.68|0.09|||Mixed Models Analysis|Treatment group, time, and the interaction between treatment and time were used as fixed factors.|Difference is omaveloxolone - placebo.|||0.09|-4.68|0.0587
72542937|NCT00931385|144615971|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.203|STANDARD_ERROR_OF_MEAN|0.03|<|0.0001||95.0|0.144|0.262|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Form 12 mcg bid minus Placebo|||0.262|0.144|<0.0001
72628846|NCT02255435|144785390|SUPERIORITY||LS Mean difference (Net)|0.58||||0.648|TWO_SIDED|95.0|-1.94|3.1|||Mixed Models Analysis|Treatment group, time, and the interaction between treatment and time were used as fixed factors.|Difference is omaveloxolone - placebo.|||3.10|-1.94|0.6480
72628847|NCT02255435|144785390|SUPERIORITY||LS Mean difference (Net)|-1.1||||0.2174|TWO_SIDED|95.0|-2.87|0.66|||Mixed Models Analysis|Treatment group, time, and the interaction between treatment and time were used as fixed factors.|Difference is omaveloxolone - placebo.|Comparison of Omaveloxolone capsules pooled with Placebo capsules||0.66|-2.87|0.2174
72628848|NCT06262477|144785391|EQUIVALENCE|The natural log (ln)- transformed Cmax was analysed using analysis of covariance (ANCOVA) model, which included actual treatment \& body weight category (\<75 kilograms \[kg\], ≥75 kg) as factors. The ratio of geometric least square means (GLSM), and corresponding confidence interval (CI) was obtained by taking the exponential of the differences in LSMs and corresponding CIs on the ln scale.|Ratio of GLSM|1.05|||||TWO_SIDED|90.3|0.974|1.13||||||||1.13|0.974|
72628849|NCT06262477|144785392|EQUIVALENCE|The natural log (ln)- transformed AUC0-inf was analyzed using ANCOVA model, which included actual treatment \& body weight category (\<75 kg, ≥75 kg) as factors. The ratio of GLSM, and corresponding CI was obtained by taking the exponential of the differences in LSMs and corresponding CIs on the ln scale.|Ratio of GLSM|1.07|||||TWO_SIDED|90.3|0.988|1.15||||||||1.15|0.988|
72329440|NCT03037476|144184382|OTHER|General Linear Model|Slope|-0.059||||0.486|TWO_SIDED|95.0|-0.227|0.108|||Mixed Models Analysis|Negative Binomial Regression||Change in Past 12 Month Tobacco Use from Baseline to 6 Month Followup||.108|-.227|.486
72628850|NCT06262477|144785393|EQUIVALENCE|The natural log (ln)- transformed AUC0-t was analyzed using ANCOVA model, which included actual treatment \& body weight category (\<75 kg, ≥75 kg) as factors. The ratio of GLSM, and corresponding CI was obtained by taking the exponential of the differences in LSMs and corresponding CIs on the ln scale.|Ratio of GLSM|1.06|||||TWO_SIDED|90.3|0.985|1.15||||||||1.15|0.985|
72628851|NCT01169259|144785441|SUPERIORITY||Hazard Ratio (HR)|0.96||||0.47|TWO_SIDED|95.0|0.88|1.06|||Regression, Cox|||||1.06|0.88|0.47
72628852|NCT01169259|144785441|SUPERIORITY||Hazard Ratio (HR)|1.03||||0.56|TWO_SIDED|95.0|0.93|1.13|||Regression, Cox|||||1.13|0.93|0.56
72628853|NCT01169259|144785442|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.69|TWO_SIDED|95.0|0.85|1.12|||Regression, Cox|||||1.12|0.85|0.69
72628854|NCT01169259|144785442|SUPERIORITY||Hazard Ratio (HR)|0.92||||0.24|TWO_SIDED|95.0|0.8|1.06|||Regression, Cox|||||1.06|0.80|0.24
72628855|NCT01169259|144785443|SUPERIORITY||Hazard Ratio (HR)|0.83||||0.08|TWO_SIDED|95.0|0.67|1.02|||Regression, Cox|||||1.02|0.67|0.08
72628856|NCT01169259|144785443|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.79|TWO_SIDED|95.0|0.79|1.2|||Regression, Cox|||||1.20|0.79|0.79
72628857|NCT01169259|144785444|SUPERIORITY||Hazard Ratio (HR)|1.02||||0.9|TWO_SIDED|95.0|0.79|1.31|||Regression, Cox|||||1.31|0.79|0.90
72628858|NCT01169259|144785444|SUPERIORITY||Hazard Ratio (HR)|0.9||||0.43|TWO_SIDED|95.0|0.7|1.16|||Regression, Cox|||||1.16|0.70|0.43
72628859|NCT01169259|144785445|SUPERIORITY||Hazard Ratio (HR)|0.88||||0.19|TWO_SIDED|95.0|0.72|1.07|||Regression, Cox|||||1.07|0.72|0.19
72628860|NCT01169259|144785445|SUPERIORITY||Hazard Ratio (HR)|1.15||||0.17|TWO_SIDED|95.0|0.94|1.39|||Regression, Cox|||||1.39|0.94|0.17
72628861|NCT01169259|144785446|SUPERIORITY||Hazard Ratio (HR)|1.09||||0.67|TWO_SIDED|95.0|0.73|1.62|||Regression, Cox|||||1.62|0.73|0.67
72628862|NCT01169259|144785446|SUPERIORITY||Hazard Ratio (HR)|1.23||||0.31|TWO_SIDED|95.0|0.83|1.83|||Regression, Cox|||||1.83|0.83|0.31
72628863|NCT01169259|144785447|SUPERIORITY||Hazard Ratio (HR)|0.96||||0.53|TWO_SIDED|95.0|0.86|1.08|||Regression, Cox|||||1.08|0.86|0.53
72628864|NCT01169259|144785447|SUPERIORITY||Hazard Ratio (HR)|0.93||||0.21|TWO_SIDED|95.0|0.82|1.04|||Regression, Cox|||||1.04|0.82|0.21
72628865|NCT01169259|144785448|SUPERIORITY||Hazard Ratio (HR)|0.96||||0.73|TWO_SIDED|95.0|0.78|1.19|||Regression, Cox|||||1.19|0.78|0.73
72628866|NCT01169259|144785448|SUPERIORITY||Hazard Ratio (HR)|0.72||||0.003|TWO_SIDED|95.0|0.59|0.9|||Regression, Cox|||||0.90|0.59|0.003
72628867|NCT01169259|144785449|SUPERIORITY||Hazard Ratio (HR)|0.95||||0.68|TWO_SIDED|95.0|0.76|1.2|||Regression, Cox|||||1.20|0.76|0.68
72628868|NCT01169259|144785449|SUPERIORITY||Hazard Ratio (HR)|1.04||||0.72|TWO_SIDED|95.0|0.83|1.31|||Regression, Cox|||||1.31|0.83|0.72
72628869|NCT01169259|144785450|SUPERIORITY||Hazard Ratio (HR)|1.11||||0.38|TWO_SIDED|95.0|0.88|1.4|||Regression, Cox|||||1.40|0.88|0.38
72628870|NCT01169259|144785450|SUPERIORITY||Hazard Ratio (HR)|0.96||||0.73|TWO_SIDED|95.0|0.76|1.21|||Regression, Cox|||||1.21|0.76|0.73
72628871|NCT01169259|144785451|SUPERIORITY||Hazard Ratio (HR)|0.99||||0.87|TWO_SIDED|95.0|0.87|1.12|||Regression, Cox|||||1.12|0.87|0.87
72628872|NCT01169259|144785451|SUPERIORITY||Hazard Ratio (HR)|1.02||||0.79|TWO_SIDED|95.0|0.9|1.15|||Regression, Cox|||||1.15|0.90|0.79
72628873|NCT01169259|144785452|SUPERIORITY||Hazard Ratio (HR)|0.94||||0.33|TWO_SIDED|95.0|0.83|1.06|||Regression, Cox|||||1.06|0.83|0.33
72628874|NCT01169259|144785452|SUPERIORITY||Hazard Ratio (HR)|1.13||||0.056|TWO_SIDED|95.0|1.0|1.28|||Regression, Cox|||||1.28|1.00|0.056
72628875|NCT01169259|144785453|SUPERIORITY||Hazard Ratio (HR)|0.93||||0.38|TWO_SIDED|95.0|0.79|1.09|||Regression, Cox|||||1.09|0.79|0.38
72628876|NCT01169259|144785453|SUPERIORITY||Hazard Ratio (HR)|0.89||||0.18|TWO_SIDED|95.0|0.76|1.05|||Regression, Cox|||||1.05|0.76|0.18
72628877|NCT01169259|144785454|SUPERIORITY||Hazard Ratio (HR)|0.75||||0.024|TWO_SIDED|95.0|0.59|0.96|||Regression, Cox|||||0.96|0.59|0.024
72628878|NCT01169259|144785454|SUPERIORITY||Hazard Ratio (HR)|0.93||||0.58|TWO_SIDED|95.0|0.73|1.19|||Regression, Cox|||||1.19|0.73|0.58
72628879|NCT01169259|144785455|SUPERIORITY||Hazard Ratio (HR)|0.96||||0.62|TWO_SIDED|95.0|0.84|1.11|||Regression, Cox|||||1.11|0.84|0.62
72628880|NCT01169259|144785455|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.72|TWO_SIDED|95.0|0.84|1.12|||Regression, Cox|||||1.12|0.84|0.72
72628881|NCT01169259|144785456|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.78|TWO_SIDED|95.0|0.79|1.19|||Regression, Cox|||||1.19|0.79|0.78
72628882|NCT01169259|144785456|SUPERIORITY||Hazard Ratio (HR)|0.78||||0.016|TWO_SIDED|95.0|0.63|0.95|||Regression, Cox|||||0.95|0.63|0.016
72628883|NCT01169259|144785457|SUPERIORITY||Hazard Ratio (HR)|0.75||||0.058|TWO_SIDED|95.0|0.55|1.01|||Regression, Cox|||||1.01|0.55|0.058
72628884|NCT01169259|144785457|SUPERIORITY||Hazard Ratio (HR)|0.99||||0.94|TWO_SIDED|95.0|0.73|1.33|||Regression, Cox|||||1.33|0.73|0.94
72628885|NCT01169259|144785458|SUPERIORITY||Hazard Ratio (HR)|0.96||||0.61|TWO_SIDED|95.0|0.83|1.12|||Regression, Cox|||||1.12|0.83|0.61
72628886|NCT01169259|144785458|SUPERIORITY||Hazard Ratio (HR)|0.83||||0.016|TWO_SIDED|95.0|0.71|0.97|||Regression, Cox|||||0.97|0.71|0.016
72628887|NCT01169259|144785459|SUPERIORITY||Hazard Ratio (HR)|1.07||||0.61|TWO_SIDED|95.0|0.83|1.39|||Regression, Cox|||||1.39|0.83|0.61
72410710|NCT02451748|144329874|EQUIVALENCE|ANOVA||||||0.4255||||||Tukey adjustment for multiple comparisons|ANOVA|A priori threshold was \<0.05.||The mean mRNA expression for IL-7 was compared between all three visits simultaneously in RA Peripheral Blood Nonnuclear Cells. The comparison between the second and third visit is as follows.||||0.4255
72628888|NCT01169259|144785459|SUPERIORITY||Hazard Ratio (HR)|0.96||||0.74|TWO_SIDED|95.0|0.74|1.24|||Regression, Cox|||||1.24|0.74|0.74
72628889|NCT01169259|144785460|SUPERIORITY||Hazard Ratio (HR)|0.76||||0.37|TWO_SIDED|95.0|0.42|1.38|||Regression, Cox|||||1.38|0.42|0.37
72628890|NCT01169259|144785460|SUPERIORITY||Hazard Ratio (HR)|1.32||||0.37|TWO_SIDED|95.0|0.72|2.39|||Regression, Cox|||||2.39|0.72|0.37
72628891|NCT01169259|144785461|SUPERIORITY||Hazard Ratio (HR)|1.6||||0.15|TWO_SIDED|95.0|0.84|3.06|||Regression, Cox|||||3.06|0.84|0.15
72628892|NCT01169259|144785461|SUPERIORITY||Hazard Ratio (HR)|0.5||||0.04|TWO_SIDED|95.0|0.26|0.97|||Regression, Cox|||||0.97|0.26|0.04
72628893|NCT01169259|144785462|SUPERIORITY||Hazard Ratio (HR)|1.27||||0.27|TWO_SIDED|95.0|0.83|1.95|||Regression, Cox|||||1.95|0.83|0.27
72628894|NCT01169259|144785462|SUPERIORITY||Hazard Ratio (HR)|0.76||||0.198|TWO_SIDED|95.0|0.49|1.16|||Regression, Cox|||||1.16|0.49|0.198
72628895|NCT01169259|144785463|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.58|TWO_SIDED|95.0|0.46|1.54|||Regression, Cox|||||1.54|0.46|0.58
72628896|NCT01169259|144785463|SUPERIORITY||Hazard Ratio (HR)|1.1||||0.76|TWO_SIDED|95.0|0.6|2.01|||Regression, Cox|||||2.01|0.60|0.76
72628897|NCT01169259|144785464|SUPERIORITY||Hazard Ratio (HR)|0.93||||0.56|TWO_SIDED|95.0|0.71|1.2|||Regression, Cox|||||1.20|0.71|0.56
72628898|NCT01169259|144785464|SUPERIORITY||Hazard Ratio (HR)|0.72||||0.014|TWO_SIDED|95.0|0.55|0.93|||Regression, Cox|||||0.93|0.55|0.014
72628899|NCT01169259|144785465|SUPERIORITY||Odds Ratio (OR)|1.08|||||TWO_SIDED|95.0|0.92|1.27||||||||1.27|0.92|
72628900|NCT01169259|144785465|SUPERIORITY||Odds Ratio (OR)|0.98|||||TWO_SIDED|95.0|0.83|1.15||||||||1.15|0.83|
72628901|NCT01169259|144785466|SUPERIORITY||Odds Ratio (OR)|1.02|||||TWO_SIDED|95.0|0.82|1.26||||||||1.26|0.82|
72628902|NCT01169259|144785466|SUPERIORITY||Odds Ratio (OR)|1.05|||||TWO_SIDED|95.0|0.84|1.29||||||||1.29|0.84|
72628903|NCT05507333|144785470|OTHER||Proportion of clinically cured patients|0.62|||||TWO_SIDED|95.0|0.4073|0.7909|||||"The proportion of clinically cured patients at Day 7-14 was calculated and presented together with a two-sided 95% CI based on the Wilson score for the proportion of Yes with continuity correction."|"It was assumed that the true clinical cure rate was 54% in the treatment group, therefore a sample size of 24 patients was needed to obtain 80% power to show that the one-sided 95% CI for the clinical cure rate was above 30%. A sample size of 26 was used to account for patients with missing data.~Hypotheses for the primary endpoint:~Null hypothesis: Clinical cure rate is less than or equal to 30%.~Alternative hypothesis (one-sided): Clinical cure rate is above 30%"||0.7909|0.4073|
72628904|NCT05507333|144785471|OTHER||Proportion with cont. clinical response|0.85|||||TWO_SIDED|95.0|0.5366|0.9729|||||"The proportion of participants with continued clinical response at Day 25 (Yes) was calculated and presented together with a two-sided 95% CI. The CI was based on the Wilson score for the proportion of Yes with a continuity correction."|||0.9729|0.5366|
72628905|NCT05507333|144785472|OTHER||Proportion with clin and mycol. cure|0.38|||||TWO_SIDED|95.0|0.2091|0.5927|||||"The proportion of participants with clinical and mycological cure at Day 7-14 (Yes) was calculated and presented with a 95% CI. The CI was based on the Wilson score for the proportion of participants with Yes with a continuity correction."|||0.5927|0.2091|
72628906|NCT05507333|144785473|OTHER||Proportion with mycological cure|0.54|||||TWO_SIDED|95.0|0.3375|0.7286|||||"The proportion of participants with mycological cure at Day 7-14 (Yes) was calculated and presented with a 95% CI. The CI was based on the Wilson score for the proportion of participants with Yes with a continuity correction."|||0.7286|0.3375|
72628907|NCT05507333|144785474|OTHER||Proportion with mycological cure|0.77|||||TWO_SIDED|95.0|0.4598|0.9384|||||"The proportion of participants with mycological cure at Day 25 (Yes) was calculated and presented with a 95% CI. The CI was based on the Wilson score for the proportion of participants recorded as Yes with a continuity correction."|||0.9384|0.4598|
72628908|NCT05507333|144785475|OTHER||Proportion with absence of Candida|0.58|||||TWO_SIDED|95.0|0.3719|0.7603|||||"The proportion of participants that did not show Candida hyphae in the wet smear (absence of/Yes) at Day 7-14 was calculated and presented together with a 95% CI based on the Wilson score for the proportion of Yes with a continuity correction."|||0.7603|0.3719|
72628909|NCT05507333|144785476|OTHER||Mean Difference (Net)|-4.5|STANDARD_DEVIATION|3.15|||TWO_SIDED|95.0|-5.77|-3.23|||||The mean change in the score for composite vulvovaginal signs and symptoms from Screening to Day 7-14 was calculated and presented together with a 95% CI.|||-3.23|-5.77|
72628910|NCT05507333|144785477|OTHER||Proportion with reduction CVVS score|0.88|||||TWO_SIDED|95.0|0.6872|0.9697|||||"The proportion of participants having a reduction in signs and symptoms (CVVS scores) on Day 7-14 vs. Screening was calculated and presented with a 95% CI based on the Wilson score for the prop. with Yes with a continuity correction."|||0.9697|0.6872|
72628911|NCT03959527|144785499|NON_INFERIORITY|A single oral 3 g dose of zoliflodacin would be considered as non-inferior to a combination of a single IM 500 mg dose of ceftriaxone and a single 1 g oral dose of azithromycin if the upper bound of the 2-sided 95% CI for the microbiological cure rate of the combination therapy minus zoliflodacin was less than 12% (prespecified non-inferiority \[NI\] margin for the primary endpoint).|Risk Difference (RD)|5.31|||||TWO_SIDED|95.0|1.38|8.65|||||95% CI of the treatment difference of ceftriaxone+ azithromycin combination minus zoliflodacin|Point estimate for the treatment difference in proportion of ceftriaxone/azithromycin combination and zoliflodacin with microbiological cure and 2-sided 95% CI calculated by Newcombe score method.||8.65|1.38|
72628912|NCT02867384|144785562|SUPERIORITY|||||||0.0008|||||||Fisher Exact|||||||0.0008
72628913|NCT02585323|144785578|SUPERIORITY||Adjusted difference in mean change|13.1||||0.05|TWO_SIDED|95.0|1.6|24.5|||ANCOVA|||We performed an intent-to-treat analysis. For the main comparison, we used analysis of covariance (ANCOVA) to estimate an adjusted mean difference comparing time in MVPA at 13 weeks (primary end point) between groups, adjusting for baseline MVPA, diagnosis, and blocking.||24.5|1.6|0.05
72628914|NCT02585323|144785579|SUPERIORITY||Adjusted difference in mean change|-29.5||||0.05|TWO_SIDED|95.0|-75.8|16.7|||ANCOVA|||||16.7|-75.8|0.05
72628915|NCT02585323|144785580|SUPERIORITY||Adjusted difference in mean change|-1.4||||0.05|TWO_SIDED|95.0|-7.8|4.9|||ANCOVA|||||4.9|-7.8|0.05
72628916|NCT02585323|144785581|SUPERIORITY||Adjusted diff in mean change at T0-T1|2.5||||0.05|TWO_SIDED|95.0|-4.2|9.5|||ANCOVA|||||9.5|-4.2|0.05
72628917|NCT02585323|144785582|SUPERIORITY||Adjusted diff in mean change at T0-T1|-3.8||||0.05|TWO_SIDED|95.0|-14.9|7.2|||ANCOVA|||||7.2|-14.9|0.05
72628918|NCT02585323|144785583|SUPERIORITY||Adjusted diff in mean change at T0-T1|2.8||||0.05|TWO_SIDED|95.0|-3.3|8.8|||ANCOVA|||||8.8|-3.3|0.05
72628919|NCT02585323|144785584|SUPERIORITY||Adjusted diff in mean change at T0-T1|1.4||||0.05|TWO_SIDED|95.0|-5.0|7.9|||ANCOVA|||||7.9|-5.0|0.05
72628920|NCT02585323|144785585|SUPERIORITY||Adjusted diff in mean change at T0-T1|-0.4||||0.05|TWO_SIDED|95.0|-1.7|0.8|||ANCOVA|||||0.8|-1.7|0.05
72628921|NCT02585323|144785586|SUPERIORITY||Adjusted diff in mean change at T0-T1|-2.3||||0.05|TWO_SIDED|95.0|-6.6|1.9|||ANCOVA|||||1.9|-6.6|0.05
72628922|NCT02585323|144785587|SUPERIORITY||Adjusted diff in mean change at T0-T1|0.7||||0.05|TWO_SIDED|95.0|0.2|1.2|||ANCOVA|||||1.2|0.2|0.05
72628923|NCT02585323|144785588|SUPERIORITY||Adjusted diff in mean change at T0-T1|0.7||||0.05|TWO_SIDED|95.0|0.2|1.1|||ANCOVA|||||1.1|0.2|0.05
72628924|NCT02585323|144785589|SUPERIORITY||Adjusted diff in mean change at T0-T1|0.3||||0.05|TWO_SIDED|95.0|-0.3|0.9|||ANCOVA|||||0.9|-0.3|0.05
72628925|NCT02585323|144785590|SUPERIORITY||Adjusted diff in mean change at T0-T1|-0.1||||0.05|TWO_SIDED|95.0|-0.4|0.2|||ANCOVA|||||0.2|-0.4|0.05
72628926|NCT02585323|144785591|SUPERIORITY||Adjusted diff in mean change at T0-T1|0.2||||0.05|TWO_SIDED|95.0|-0.1|0.5|||ANCOVA|||||0.5|-0.1|0.05
72628927|NCT02585323|144785592|SUPERIORITY||Adjusted diff in mean change at T0-T1|0.1||||0.05|TWO_SIDED|95.0|-0.6|0.8|||ANCOVA|||||0.8|-0.6|0.05
72628928|NCT02585323|144785593|SUPERIORITY||Adjusted diff in mean change at T0-T1|0.1||||0.05|TWO_SIDED|95.0|-0.1|0.3|||ANCOVA|||||0.3|-0.1|0.05
72628929|NCT02960893|144785629|SUPERIORITY||LS Mean|0.2|STANDARD_ERROR_OF_MEAN|0.4||0.519|TWO_SIDED|95.0|-0.5|0.9||Significance was evaluated at a 2-sided alpha level of 0.05|Mixed Model with Repeated Measures|Fixed effects: treatment, baseline (BL) gait severity, visit, treatment-by-visit interaction; Covariate: BL Total SARA score; Random effect: subject||||0.9|-0.5|0.519
72628930|NCT03692312|144785635|SUPERIORITY||Mean Difference (Final Values)|1.75|STANDARD_ERROR_OF_MEAN|0.875||0.0514|TWO_SIDED|95.0|-0.01|3.51|||MMRM|||Analysis is a mixed model for repeated measures (MMRM) analysis with treatment, visit, age group and treatment by visit interaction as fixed effects and baseline value as a covariate. An unstructured variance-covariance matrix has been used.||3.51|-0.01|0.0514
72628931|NCT03692312|144785636|SUPERIORITY||Mean Difference (Final Values)|0.34|STANDARD_ERROR_OF_MEAN|0.268||0.2124|TWO_SIDED|95.0|-0.2|0.88|||MMRM|||Analysis is a mixed model for repeated measures (MMRM) analysis with treatment, visit, age group and treatment by visit interaction as fixed effects and baseline value as a covariate. An unstructured variance-covariance matrix has been used.||0.88|-0.20|0.2124
72628932|NCT03692312|144785637|SUPERIORITY||Mean Difference (Final Values)|4.74|STANDARD_ERROR_OF_MEAN|1.104|<|0.0001|TWO_SIDED|95.0|2.51|6.96|||MMRM|||Analysis is a mixed model for repeated measures (MMRM) analysis with treatment, visit, age group and treatment by visit interaction as fixed effects and baseline value as a covariate. An unstructured variance-covariance matrix has been used.||6.96|2.51|<0.0001
72628933|NCT03692312|144785638|SUPERIORITY||Mean Difference (Final Values)|3.18|STANDARD_ERROR_OF_MEAN|1.099||0.0059|TWO_SIDED|95.0|0.96|5.39|||MMRM|||Analysis is a mixed model for repeated measures (MMRM) analysis with treatment, visit, age group and treatment by visit interaction as fixed effects and baseline value as a covariate. An unstructured variance-covariance matrix has been used.||5.39|0.96|0.0059
72628934|NCT03692312|144785639|SUPERIORITY||Mean Difference (Final Values)|-0.08|STANDARD_ERROR_OF_MEAN|0.108||0.4634|TWO_SIDED|95.0|-0.3|0.14|||MMRM|||Analysis is a mixed model for repeated measures (MMRM) analysis with treatment, visit, age group and treatment by visit interaction as fixed effects and baseline value as a covariate. An unstructured variance-covariance matrix has been used.||0.14|-0.30|0.4634
72628935|NCT03692312|144785640|SUPERIORITY||Mean Difference (Final Values)|-0.35|STANDARD_ERROR_OF_MEAN|0.564||0.5385|TWO_SIDED|95.0|-1.49|0.79|||MMRM|||Analysis is a mixed model for repeated measures (MMRM) analysis with treatment, visit, age group and treatment by visit interaction as fixed effects and baseline value as a covariate. An unstructured variance-covariance matrix has been used.||0.79|-1.49|0.5385
72628936|NCT03692312|144785643|SUPERIORITY||Mean Difference (Final Values)|0.29|STANDARD_ERROR_OF_MEAN|0.764||0.711|TWO_SIDED|95.0|-1.26|1.83|||MMRM|||Analysis is a mixed model for repeated measures (MMRM) analysis with treatment, visit, age group and treatment by visit interaction as fixed effects and baseline value as a covariate. An unstructured variance-covariance matrix has been used.||1.83|-1.26|0.7110
72628937|NCT03692312|144785644|SUPERIORITY||Mean Difference (Final Values)|0.09|STANDARD_ERROR_OF_MEAN|0.326||0.7861|TWO_SIDED|95.0|-0.57|0.75|||MMRM|||Analysis is a mixed model for repeated measures (MMRM) analysis with treatment, visit, age group and treatment by visit interaction as fixed effects and baseline value as a covariate. An unstructured variance-covariance matrix has been used.||0.75|-0.57|0.7861
72628938|NCT03692312|144785645|SUPERIORITY||Mean Difference (Final Values)|0.06|STANDARD_ERROR_OF_MEAN|0.123||0.6282|TWO_SIDED|95.0|-0.19|0.31|||MMRM|||Analysis is a mixed model for repeated measures (MMRM) analysis with treatment, visit, age group and treatment by visit interaction as fixed effects and baseline value as a covariate. A compound symmetry variance-covariance matrix has been used.||0.31|-0.19|0.6282
72628939|NCT03692312|144785646|SUPERIORITY|||||||0.0428|||||||t-test, 2 sided|||||||0.0428
72628940|NCT03692312|144785647|SUPERIORITY||Ratio|0.77|STANDARD_ERROR_OF_MEAN|0.094||0.0379|TWO_SIDED|95.0|0.6|0.98|||MMRM|||Analysis is a mixed model for repeated measures (MMRM) analysis with treatment, visit, age group and treatment by visit interaction as fixed effects and baseline value as a covariate. An unstructured variance-covariance matrix has been used.||0.98|0.60|0.0379
72628941|NCT03692312|144785649|SUPERIORITY|||||||0.078|||||||t-test, 2 sided|||Cmax upper quantiles group compared to the placebo group for mean change from baseline; two-tailed t-test assuming unequal variance.||||0.078
72628942|NCT03692312|144785651|SUPERIORITY|||||||0.29|||||||t-test, 2 sided|||Cmax upper quantiles group compared to the placebo group for mean change from baseline; two-tailed t-test assuming unequal variance.||||0.29
72628943|NCT03692312|144785653|SUPERIORITY|||||||0.077|||||||t-test, 2 sided|||Cmax upper quantiles group compared to the placebo group for mean change from baseline (absolute value); two-tailed t-test assuming unequal variance.||||0.077
72628944|NCT03692312|144785654|SUPERIORITY|||||||0.071|||||||t-test, 2 sided|||Cmax upper quantiles group compared to placebo group for mean Raw Score; two-tailed t-test assuming unequal variance.||||0.071
72628945|NCT06170242|144785663|SUPERIORITY|P-values are from analysis of covariance (ANCOVA) with treatment group as main effect and the baseline value as a covariate. The baseline value is defined as the qRT-PCR viral load value at the time of first dose of IMP.|Difference in least square (LS) means|-540.56|||<|0.0001|TWO_SIDED|95.0|-680.8|-400.33|||ANCOVA|||High Dose versus (vs) Placebo||-400.33|-680.80|<0.0001
72628946|NCT06170242|144785663|SUPERIORITY|P-values are from ANCOVA with treatment group as main effect and the baseline value as a covariate. The baseline value is defined as the qRT-PCR viral load value at the time of first dose of IMP.|Difference in LS mean|-523.12|||<|0.0001|TWO_SIDED|95.0|-674.46|-371.78|||ANCOVA|||Low Dose vs Placebo||-371.78|-674.46|<0.0001
72628947|NCT06170242|144785663|SUPERIORITY|P-values are from ANCOVA with treatment group as main effect and the baseline value as a covariate. The baseline value is defined as the qRT-PCR viral load value at the time of first dose of IMP.|Difference in LS means|-536.3|||<|0.0001|TWO_SIDED|95.0|-641.71|-430.89|||ANCOVA|||Pooled EDP-323 vs Placebo||-430.89|-641.71|<0.0001
72628948|NCT06170242|144785664|SUPERIORITY|P-values are from ANCOVA with treatment group as main effect and the baseline value as a covariate. The baseline value is defined as the qRT-PCR viral load value at the time of first dose of IMP.|Difference in LS mean|-3.83|||<|0.0001|TWO_SIDED|95.0|-4.85|-2.81|||ANCOVA|||High Dose vs Placebo||-2.81|-4.85|<0.0001
72628949|NCT06170242|144785664|SUPERIORITY|P-values are from ANCOVA with treatment group as main effect and the baseline value as a covariate. The baseline value is defined as the qRT-PCR viral load value at the time of first dose of IMP.|Difference in LS mean|-4.16|||<|0.0001|TWO_SIDED|95.0|-5.44|-2.89|||ANCOVA|||Low Dose vs Placebo||-2.89|-5.44|<0.0001
72628950|NCT06170242|144785665|SUPERIORITY|P-values are from ANCOVA with treatment group as main effect and the baseline value as a covariate. The baseline value is defined as the qRT-PCR viral load value at the time of first dose of IMP.|Difference in LS mean|-0.29||||0.633|TWO_SIDED|95.0|-1.5|0.92|||ANCOVA|||High Dose vs Placebo||0.92|-1.50|0.6330
72628951|NCT06170242|144785665|SUPERIORITY|P-values are from ANCOVA with treatment group as main effect and the baseline value as a covariate. The baseline value is defined as the qRT-PCR viral load value at the time of first dose of IMP.|Difference in LS mean|-0.14||||0.8309|TWO_SIDED|95.0|-1.46|1.17|||ANCOVA|||Lose Dose vs Placebo||1.17|-1.46|0.8309
72628952|NCT06170242|144785667|SUPERIORITY|P-values are from ANCOVA with treatment group as main effect and the baseline value as a covariate. The baseline value is defined as the qRT-PCR viral load value at the time of first dose of IMP.|Difference in LS mean|-1.57||||0.0021|TWO_SIDED|95.0|-2.53|-0.61|||ANCOVA|||High Dose vs Placebo.||-0.61|-2.53|0.0021
72628953|NCT06170242|144785667|SUPERIORITY|P-values are from ANCOVA with treatment group as main effect and the baseline value as a covariate. The baseline value is defined as the qRT-PCR viral load value at the time of first dose of IMP.|Difference in LS mean|-1.09||||0.0905|TWO_SIDED|95.0|-2.35|0.18|||ANCOVA|||Lose Dose vs Placebo||0.18|-2.35|0.0905
72628954|NCT06170242|144785670|SUPERIORITY|P-values are from ANCOVA with treatment group as main effect and the baseline value as a covariate. The baseline value is defined as the cell culture viral load value at the time of first dose of IMP.|Difference in LS mean|-203.63|||<|0.0001|TWO_SIDED|95.0|-272.18|-135.07|||ANCOVA|||High Dose vs Placebo||-135.07|-272.18|<0.0001
72628955|NCT06170242|144785670|SUPERIORITY|P-values are from ANCOVA with treatment group as main effect and the baseline value as a covariate. The baseline value is defined as the cell culture viral load value at the time of first dose of IMP.|Difference in LS mean|-215.03|||<|0.0001|TWO_SIDED|95.0|-288.84|-141.22|||ANCOVA|||Low Dose vs Placebo||-141.22|-288.84|<0.0001
72628956|NCT06170242|144785671|SUPERIORITY|P-values are from ANCOVA with treatment group as main effect and the baseline value as a covariate. The baseline value is defined as the cell culture viral load value at the time of first dose of IMP.|Difference in LS mean|-3.22|||<|0.0001|TWO_SIDED|95.0|-4.05|-2.4|||ANCOVA|||High Dose vs Placebo||-2.40|-4.05|<0.0001
72628957|NCT06170242|144785671|SUPERIORITY|P-values are from ANCOVA with treatment group as main effect and the baseline value as a covariate. The baseline value is defined as the cell culture viral load value at the time of first dose of IMP.|Difference in LS mean|-3.23|||<|0.0001|TWO_SIDED|95.0|-4.11|-2.34|||ANCOVA|||Low Dose vs Placebo||-2.34|-4.11|<0.0001
72628958|NCT06170242|144785672|SUPERIORITY|P-values are from ANCOVA with treatment group as main effect and the baseline value as a covariate. The baseline value is defined as the cell culture viral load value at the time of first dose of IMP.|Difference in LS mean|1.44||||0.0238|TWO_SIDED|95.0|0.2|2.68|||ANCOVA|||High Dose vs Placebo||2.68|0.20|0.0238
72628959|NCT06170242|144785672|SUPERIORITY|P-values are from ANCOVA with treatment group as main effect and the baseline value as a covariate. The baseline value is defined as the cell culture viral load value at the time of first dose of IMP.|Difference in LS mean|1.68||||0.0134|TWO_SIDED|95.0|0.36|2.99|||ANCOVA|||Low Dose vs Placebo||2.99|0.36|0.0134
72628960|NCT06170242|144785674|SUPERIORITY|P-values are from ANCOVA with treatment group as main effect and the baseline value as a covariate. The baseline value is defined as the cell culture viral load value at the time of first dose of IMP.|Difference in LS mean|-2.18||||0.0389|TWO_SIDED|95.0|-4.23|-0.12|||ANCOVA|||High Dose vs Placebo||-0.12|-4.23|0.0389
72628961|NCT06170242|144785674|SUPERIORITY|P-values are from ANCOVA with treatment group as main effect and the baseline value as a covariate. The baseline value is defined as the cell culture viral load value at the time of first dose of IMP.|Difference in LS mean|-1.31||||0.2713|TWO_SIDED|95.0|-3.73|1.1|||ANCOVA|||Low Dose vs Placebo||1.10|-3.73|0.2713
72628962|NCT06170242|144785676|SUPERIORITY|P-values are from ANCOVA with treatment group as main effect and the baseline value as a covariate. The baseline value is defined as the TSS value at the time of first dose of IMP.|Difference in LS mean|-280.61|||<|0.0001|TWO_SIDED|95.0|-404.44|-156.77|||ANCOVA|||High Dose vs Placebo||-156.77|-404.44|<0.0001
72628963|NCT06170242|144785676|SUPERIORITY|P-values are from ANCOVA with treatment group as main effect and the baseline value as a covariate. The baseline value is defined as the TSS value at the time of first dose of IMP.|Difference in LS mean|-301.15|||<|0.0001|TWO_SIDED|95.0|-428.53|-173.76|||ANCOVA|||Low Dose vs Placebo||-173.76|-428.53|<0.0001
72628964|NCT06170242|144785677|SUPERIORITY|P-values are from ANCOVA with treatment group as main effect and the baseline value as a covariate. The baseline value is defined as the TSS value at the time of first dose of IMP.|Difference in LS mean|-3.64|||<|0.0001|TWO_SIDED|95.0|-5.26|-2.02|||ANCOVA|||High Dose vs Placebo||-2.02|-5.26|<0.0001
72628965|NCT06170242|144785677|SUPERIORITY|P-values are from ANCOVA with treatment group as main effect and the baseline value as a covariate. The baseline value is defined as the TSS value at the time of first dose of IMP.|Difference in LS mean|-3.7|||<|0.0001|TWO_SIDED|95.0|-5.35|-2.05|||ANCOVA|||Low Dose vs Placebo||-2.05|-5.35|<0.0001
72628966|NCT06170242|144785678|SUPERIORITY|P-values are from ANCOVA with treatment group as main effect and the baseline value as a covariate. The baseline value is defined as the TSS value at the time of first dose of IMP.|Difference in LS mean|-1.08||||0.0552|TWO_SIDED|95.0|-2.19|0.03|||ANCOVA|||High Dose vs Placebo||0.03|-2.19|0.0552
72628967|NCT06170242|144785678|SUPERIORITY|P-values are from ANCOVA with treatment group as main effect and the baseline value as a covariate. The baseline value is defined as the TSS value at the time of first dose of IMP.|Difference in LS mean|-0.38||||0.5599|TWO_SIDED|95.0|-1.69|0.92|||ANCOVA|||Low Dose vs Placebo||0.92|-1.69|0.5599
72628968|NCT06170242|144785679|SUPERIORITY|P-values are from ANCOVA with treatment group as main effect and the baseline value as a covariate. The baseline value is defined as the TSS value at the time of first dose of IMP.|Difference in LS mean|-1.04||||0.0307|TWO_SIDED|95.0|-1.97|-0.1|||ANCOVA|||High Dose vs Placebo||-0.10|-1.97|0.0307
72628969|NCT06170242|144785679|SUPERIORITY|P-values are from ANCOVA with treatment group as main effect and the baseline value as a covariate. The baseline value is defined as the TSS value at the time of first dose of IMP.|Difference in LS mean|-0.53||||0.4119|TWO_SIDED|95.0|-1.81|0.76|||ANCOVA|||||0.76|-1.81|0.4119
72628970|NCT06170242|144785680|SUPERIORITY|P-values are from ANCOVA with treatment group as main effect and the baseline value as a covariate. The baseline value is defined as the biospecimen value at the time of first dose of IMP.|Difference in LS mean|-13.37||||0.0042|TWO_SIDED|95.0|-22.34|-4.4|||ANCOVA|||High Dose vs Placebo||-4.40|-22.34|0.0042
72628971|NCT06170242|144785680|SUPERIORITY|P-values are from ANCOVA with treatment group as main effect and the baseline value as a covariate. The baseline value is defined as the biospecimen value at the time of first dose of IMP.|Difference in LS mean|-13.19||||0.0058|TWO_SIDED|95.0|-22.38|-4.0|||ANCOVA|||Low Dose vs Placebo||-4.00|-22.38|0.0058
72628972|NCT06170242|144785681|SUPERIORITY|P-values are from ANCOVA with treatment group as main effect and the baseline value as a covariate. The baseline value is defined as the biospecimen value at the time of first dose of IMP.|Difference in LS mean|-18.72||||0.0026|TWO_SIDED|95.0|-30.61|-6.84|||ANCOVA|||High Dose vs Placebo||-6.84|-30.61|0.0026
72628973|NCT06170242|144785681|SUPERIORITY|P-values are from ANCOVA with treatment group as main effect and the baseline value as a covariate. The baseline value is defined as the biospecimen value at the time of first dose of IMP.|Difference in LS mean|-19.28||||0.0022|TWO_SIDED|95.0|-31.3|-7.26|||ANCOVA|||||-7.26|-31.30|0.0022
72628974|NCT05365958|144785791|SUPERIORITY||||||<|0.001|||||||Repeated Measures t-test of differences|||||||<.001
72628975|NCT05365958|144785792|SUPERIORITY||||||<|0.001|||||||Repeated Measures t-test of differences|||||||<.001
72628976|NCT05098158|144785796|EQUIVALENCE|Paired t tests had .05 set as level of significance to reject null hypothesis. Sample powered to generate effect size for future studies.|Mean Difference (Final Values)|3.9|||<|0.001|TWO_SIDED|||||Actual p value results above; Not adjusted due to pilot study aim to generate effect size comparing pre and posttest data|t-test, 2 sided|||Paired t tests of pre and posttest data||||<0.001
72628977|NCT05098158|144785797|EQUIVALENCE|Paired t tests had .05 set as level of significance to reject null hypothesis. Sample powered to generate effect size for future studies.|Mean Difference (Final Values)|5.6||||0.003|TWO_SIDED|||||Actual p value results above; Not adjusted due to pilot study aim to generate effect size comparing pre and posttest data|t-test, 2 sided|||Paired t tests of pre and posttest data||||0.003
72628978|NCT05098158|144785798|EQUIVALENCE|Paired t tests had .05 set as level of significance to reject null hypothesis. Sample powered to generate effect size for future studies.|Mean Difference (Final Values)|3.1||||0.011|TWO_SIDED|||||Actual p value results above; Not adjusted due to pilot study aim to generate effect size comparing pre and posttest data|t-test, 2 sided|||Paired t tests of pre and posttest data||||0.011
72410711|NCT02451748|144329874|EQUIVALENCE|ANOVA||||||0.1037||||||Tukey adjustment for multiple comparisons|ANOVA|A priori threshold was \<0.05.||The mean mRNA expression for IL-7R was compared between all three visits simultaneously in RA Peripheral Blood Nonnuclear Cells. The comparison between the first and second visit is as follows.||||0.1037
72410712|NCT02451748|144329874|EQUIVALENCE|ANOVA||||||0.0008||||||Tukey adjustment for multiple comparisons|ANOVA|A priori threshold was \<0.05.||The mean mRNA expression for IL-7R was compared between all three visits simultaneously in RA Peripheral Blood Nonnuclear Cells. The comparison between the first and third visit is as follows.||||0.0008
72410713|NCT02451748|144329874|EQUIVALENCE|ANOVA||||||0.0001||||||Tukey adjustment for multiple comparisons|ANOVA|A priori threshold was \<0.05.||The mean mRNA expression for IL-7R was compared between all three visits simultaneously in RA Peripheral Blood Nonnuclear Cells. The comparison between the second and third visit is as follows.||||0.0001
72421512|NCT01342458|144354199|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||We used a casewise two-way ANOVA for repeated measures (two independent groups and three repeated measures/assessments), followed by a post hoc Newman-Keuls test to verify the interaction effect of group vs. time between T0 (baseline), T3 (3th month) and T6 (6th month).||||<0.001
72577483|NCT02135614|144681881|SUPERIORITY||Treatment difference|0.08||||0.046|TWO_SIDED|95.0|0.0|0.16||P-value was calculated from the ANCOVA model including the baseline value, CFS score and stratification factor as covariates.|ANCOVA|||||0.16|0.00|0.046
72577484|NCT02135614|144681882|SUPERIORITY|||||||0.39||||||P-value was calculated from the negative binomial model with the stratification factor as covariate.|Negative Binomial Model|||||||0.39
72577485|NCT02135614|144681883|SUPERIORITY|||||||0.004||||||P-value from the negative binomial model comparing the rate ratio between treatment groups, adjusted for the stratification factor.|Negative Binomial Model|||||||0.004
72577486|NCT03713632|144681912|SUPERIORITY||Odds Ratio (OR)|1.64||||0.0149|TWO_SIDED|95.0|1.05|2.55||one-sided p-value|Regression, Logistic|||||2.55|1.05|0.0149
72577487|NCT03713632|144681912|SUPERIORITY||Odds Ratio (OR)|1.9||||0.0022|TWO_SIDED|95.0|1.22|2.96||one-sided p-value|Regression, Logistic|||||2.96|1.22|0.0022
72577488|NCT03713632|144681913|SUPERIORITY||Mean Difference (Net)|-16.33||||0.0051|TWO_SIDED|95.0|-28.79|-3.88||one-side p-value|ANCOVA|||||-3.88|-28.79|0.0051
72577489|NCT03713632|144681913|SUPERIORITY||Mean Difference (Net)|-22.94||||0.0001|TWO_SIDED|95.0|-35.24|-10.63||one-side p-value|ANCOVA|||||-10.63|-35.24|0.0001
72577490|NCT03713632|144681914|SUPERIORITY||Odds Ratio (OR)|0.68||||0.0732|TWO_SIDED|95.0|0.41|1.14||one-sided p-value|Regression, Logistic|||||1.14|0.41|0.0732
72577491|NCT03713632|144681914|SUPERIORITY||Odds Ratio (OR)|0.49||||0.0049|TWO_SIDED|95.0|0.29|0.84||one-sided p-value|Regression, Logistic|||||0.84|0.29|0.0049
72577492|NCT03713632|144681915|SUPERIORITY||Odds Ratio (OR)|2.29||||0.0026|TWO_SIDED|95.0|1.28|4.09||one-sided p-value|Regression, Logistic|||||4.09|1.28|0.0026
72577493|NCT03713632|144681915|SUPERIORITY||Odds Ratio (OR)|1.86||||0.0206|TWO_SIDED|95.0|1.03|3.37||one-sided p-value|Regression, Logistic|||||3.37|1.03|0.0206
72577494|NCT00101283|144682040|SUPERIORITY_OR_OTHER_LEGACY||Overall Response Percent|18.8|||||TWO_SIDED|90.0|5.4|41.7|||||Overall response percent for Pemetrexed/Carboplatin arm (percent of eligible, treated patients with complete or partial response)|The treatment was to be considered promising if a true response rate of 40% or higher was observed, whereas a rate of 15% or less would not be of interest. 3 or more responses were required to expand accrual to a second stage. This expansion did not occur.||41.7|5.4|
72329441|NCT03037476|144184382|OTHER|General Linear Model|Slope|0.006||||0.942|TWO_SIDED|95.0|-0.16|0.172|||Mixed Models Analysis|Negative Binomial Regression||Change in Past 12 Month Tobacco Use from Baseline to 12 Month Followup||.172|-.160|.942
72577495|NCT00101283|144682040|SUPERIORITY_OR_OTHER_LEGACY||Overall Response Percent|0.0|||||TWO_SIDED|90.0|0.0|20.6|||||Overall response percent for Pemetrexed/Gemcitabine arm (percent of eligible, treated patients with complete or partial response)|The treatment was to be considered promising if a true response rate of 40% or higher was observed, whereas a rate of 15% or less would not be of interest. 3 or more responses were required to expand accrual to a second stage. This expansion did not occur.||20.6|0.0|
72577496|NCT05084924|144682049|SUPERIORITY|||||||0.049|||||||ANOVA|Main effect of stimulation: F(2,32) = 3.32||||||0.049
72577497|NCT05084924|144682050|SUPERIORITY|||||||0.004||||||Main effect of stimulation: F(2,32) = 6.67|ANOVA|||||||0.004
72577498|NCT03774407|144682051|OTHER|||||||0.002||||||This P value reported was for bladder urinary frequency change from baseline to 9 months|p value|||||||0.002
72577499|NCT04841577|144682054|NON_INFERIORITY|Non-inferiority is demonstrated if the upper limit of the 2-sided 95% confidence interval (CI) of the group GMT ratio \[Control group divided by Co Ad group\] for RSVPreF3 OA investigational vaccine is ≤ (equal to or smaller than) 1.5.|Adjusted group GMT ratio|1.27|||||TWO_SIDED|95.0|1.12|1.44||||||Adjusted ratios of Control group over Co-Ad Group in RSV-A Neutralizing antibody GMTs at one month after RSV\_PreF3 OA investigational vaccination. An Analysis of Covariance (ANCOVA) model was used to analyse post-vaccination log-transformed titers of RSV-A neutralizing antibodies The ANCOVA model included the treatment group, the age category (age at vaccination: 60-69, 70-79 or \>=80 years), country and sex as fixed effects and the pre-dose log-10 titer as covariate.||1.44|1.12|
72577500|NCT04841577|144682055|NON_INFERIORITY|Non-inferiority is demonstrated if the upper limit of the 2-sided 95% confidence interval (CI) of the group GMT ratio \[Control group divided by Co Ad group\] for each of the FLU vaccine strains is ≤1.5.|Adjusted geometric mean titer ratio|1.17|||||TWO_SIDED|95.0|1.02|1.35||||||For the Flu A/Hong Kong/2671/2019 (H3N2) strain, an ANCOVA model was used to analyze post-vaccination log-transformed titers. The ANCOVA model included the treatment group, the age category (age at vaccination: 60-69, 70-79 or \>=80 years), country and sex as fixed effects and the pre-dose log-10 transformed titer as covariate.||1.35|1.02|
72577501|NCT04841577|144682055|NON_INFERIORITY|Non-inferiority is demonstrated if the upper limit of the 2-sided 95% confidence interval (CI) of the group GMT ratio \[Control group divided by Co Ad group\] for each of the FLU vaccine strains is ≤1.5.|Adjusted geometric mean Titer ratio|1.22|||||TWO_SIDED|95.0|1.03|1.44||||||For the Flu A/Victoria/2570/2019 (H1N1) strain, an ANCOVA model was used to analyze post-vaccination log-transformed titers. The ANCOVA model included the treatment group, the age category (age at vaccination: 60-69, 70-79 or \>=80 years), country and sex as fixed effects and the pre-dose log-10 transformed titer as covariate.||1.44|1.03|
72410714|NCT00673049|144329891|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.091||||0.35|TWO_SIDED|95.0|0.909|1.31||One-sided significance level at alpha=0.024 was used. Two-sided p-value was reported.|Log Rank|Nominal p-values were reported without adjustment for the interim analysis.||P-value was calculated using log-rank test stratified by gender (Male or Female), Eastern Cooperative Oncology Group (ECOG) performance status (less than or equal to \[=\<1\] or 2), and region (United States/Canada, European Union, rest of world). The stratified Cox proportional hazards model was fitted to estimate the hazard ratio, using the same stratification variables as above.||1.310|0.909|0.35
72410715|NCT00673049|144329892|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.075||||0.426|TWO_SIDED|95.0|0.898|1.287||One-sided significance level at alpha=0.001 was used. Two-sided p-value was reported.|Log Rank|||P-value was calculated using log-rank test stratified by gender (Male or Female), ECOG performance status (less than or equal to \[=\<1\] or 2), and region (United States/Canada, European Union, rest of world). The stratified Cox proportional hazards model was fitted to estimate the hazard ratio, using the same stratification variables as above.||1.287|0.898|0.426
72410716|NCT00673049|144329893|SUPERIORITY_OR_OTHER||Difference in response rates|1.668||||0.338|TWO_SIDED|95.0|-1.7|5.1|||Chi-squared|||||5.1|-1.7|0.338
72410717|NCT01175824|144329901|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the upper limit of the 95% confidence interval (CI) of the difference in the LS mean between the two treatment arms (twice-daily insulin lispro Low Mixture minus the comparator arm) at 24 weeks is \<0.4%.|LS mean difference|-0.21|||||TWO_SIDED|95.0|-0.38|-0.04||||||||-0.04|-0.38|
72410718|NCT01175824|144329902|SUPERIORITY_OR_OTHER|||||||0.1858||95.0|||||Mixed Models Analysis|||||||0.1858
72410719|NCT01175824|144329903|SUPERIORITY_OR_OTHER|||||||0.3588||95.0||||HbA1c concentration \<7%|Fisher Exact|||||||0.3588
72542938|NCT00931385|144615972|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.147|STANDARD_ERROR_OF_MEAN|0.03|<|0.0001||95.0|0.087|0.207|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Olo 5 mcg qd minus Placebo|||0.207|0.087|<0.0001
72542939|NCT00931385|144615972|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.171|STANDARD_ERROR_OF_MEAN|0.03|<|0.0001||95.0|0.112|0.231|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Olo 10 mcg qd minus Placebo|||0.231|0.112|<0.0001
72577502|NCT04841577|144682055|NON_INFERIORITY|Non-inferiority is demonstrated if the upper limit of the 2-sided 95% confidence interval (CI) of the group GMT ratio \[Control group divided by Co Ad group\] for each of the FLU vaccine strains is ≤1.5.|Adjusted geometric mean Titer ratio|1.17|||||TWO_SIDED|95.0|1.04|1.32||||||For the Flu B/Phuket/3073/2013 (Yamagata) strain, an ANCOVA model was used to analyze post-vaccination log-transformed titers. The ANCOVA model included the treatment group, the age category (age at vaccination: 60-69, 70-79 or \>=80 years), country and sex as fixed effects and the pre-dose log-10 transformed titer as covariate.||1.32|1.04|
72577503|NCT04841577|144682055|NON_INFERIORITY|Non-inferiority is demonstrated if the upper limit of the 2-sided 95% confidence interval (CI) of the group GMT ratio \[Control group divided by Co Ad group\] for each of the FLU vaccine strains is ≤1.5.|Adjusted geometric mean Titer ratio|1.1|||||TWO_SIDED|95.0|0.95|1.26||||||For the Flu B/Washington/02/2019 (Victoria) strain, an ANOVA model was used to analyze post-vaccination log-transformed titers. The ANCOVA model included the treatment group, the age category (age at vaccination: 60-69, 70-79 or \>=80 years), country and sex as fixed effects and the pre-dose log-10 transformed titer as covariate.||1.26|0.95|
72577504|NCT04841577|144682056|NON_INFERIORITY|Non-inferiority is demonstrated if the upper limit of the 2-sided 95% CI on the group difference (Control group minus Co-Ad group) in seroconversion rate is ≤10% for HI antibody titers.|Difference in percentage|2.6|||||TWO_SIDED|95.0|-4.13|9.3|||Miettinen and Nurminen|||For the Flu A/Hong Kong/2671/2019 (H3N2) strain, the 2-sided 95% CI on group difference in seroconversion rate (Control group minus Co-Ad group).||9.30|-4.13|
72577505|NCT04841577|144682056|NON_INFERIORITY|Non-inferiority is demonstrated if the upper limit of the 2-sided 95% CI on the group difference (Control group minus Co-Ad group) in seroconversion rate is ≤10% for HI antibody titers.|Difference in percentage|4.53|||||TWO_SIDED|95.0|-0.77|9.83|||Miettinen and Nurminen|||For the Flu A/Victoria/2570/2019 (H1N1) strain, the 2-sided 95% CI on group difference in seroconversion rate (Control group minus Co-Ad group).||9.83|-0.77|
72577506|NCT04841577|144682056|NON_INFERIORITY|Non-inferiority is demonstrated if the upper limit of the 2-sided 95% CI on the group difference (Control group minus Co-Ad group) in seroconversion rate is ≤10% for HI antibody titers.|Difference in percentage|4.04|||||TWO_SIDED|95.0|-2.21|10.28|||Miettinen and Nurminen|||For the Flu B/Phuket/3073/2013 (Yamagata) strain, the 2-sided 95% CI on group difference in seroconversion rate (Control group minus Co-Ad group).||10.28|-2.21|
72577507|NCT04841577|144682056|NON_INFERIORITY|Non-inferiority is demonstrated if the upper limit of the 2-sided 95% CI on the group difference (Control group minus Co-Ad group) in seroconversion rate is ≤10% for HI antibody titers.|Difference in percentage|0.41|||||TWO_SIDED|95.0|-6.07|6.9|||Miettinen and Nurminen|||For the Flu B/Washington/02/2019 (Victoria) strain, the 2-sided 95% CI on group difference in seroconversion rate (Control group minus Co-Ad group).||6.90|-6.07|
72410720|NCT01175824|144329903|SUPERIORITY_OR_OTHER|||||||0.5958||95.0||||HbA1c \<=6.5%|Fisher Exact|||||||0.5958
72410721|NCT01175824|144329904|SUPERIORITY_OR_OTHER|||||||0.0827||95.0||||p-value is for the Week 12 comparison|Mixed Models Analysis|||||||0.0827
72410722|NCT01175824|144329904|SUPERIORITY_OR_OTHER|||||||0.5353||95.0||||p-value is for the Week 24 comparison|Mixed Models Analysis|||||||0.5353
72410723|NCT01175824|144329908|SUPERIORITY_OR_OTHER|||||||0.2833||95.0||||p-value is for the comparison at Week 12.|Mixed Models Analysis|||||||0.2833
72410724|NCT01175824|144329908|SUPERIORITY_OR_OTHER|||||||0.0176||95.0||||p-value is for the comparison at Week 24.|Mixed Models Analysis|||||||0.0176
72421513|NCT01342458|144354199|SUPERIORITY_OR_OTHER||Effect size|1.28|||<|0.001|TWO_SIDED||||||post hoc Newman-Keuls|||From baseline to 3rd month.||||<0.001
72542940|NCT00931385|144615972|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.251|STANDARD_ERROR_OF_MEAN|0.03|<|0.0001||95.0|0.191|0.311|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Form 12 mcg bid minus Placebo|||0.311|0.191|<0.0001
72628979|NCT05098158|144785799|EQUIVALENCE|Paired t tests had .05 set as level of significance to reject null hypothesis. Sample powered to generate effect size for future studies.|Mean Difference (Final Values)|1.9||||0.168|TWO_SIDED|||||Actual p value results above; Not adjusted due to pilot study aim to generate effect size comparing pre and posttest data|t-test, 2 sided|||Paired t tests of pre and posttest data||||0.168
72628980|NCT05098158|144785800|EQUIVALENCE|Paired t tests had .05 set as level of significance to reject null hypothesis. Sample powered to generate effect size for future studies.|Mean Difference (Final Values)|1.1||||0.456|TWO_SIDED|||||Actual p value results above; Not adjusted due to pilot study aim to generate effect size comparing pre and posttest data|t-test, 2 sided|||Paired t tests of pre and posttest data||||0.456
72628981|NCT05098158|144785801|EQUIVALENCE|Paired t tests had .05 set as level of significance to reject null hypothesis. Sample powered to generate effect size for future studies.|Mean Difference (Final Values)|0.8||||0.517|TWO_SIDED|||||Actual p value results above; Not adjusted due to pilot study aim to generate effect size comparing pre and posttest data|t-test, 2 sided|||Paired t tests of pre and posttest data||||0.517
72628982|NCT05098158|144785802|EQUIVALENCE|Paired t tests had .05 set as level of significance to reject null hypothesis. Sample powered to generate effect size for future studies.|Mean Difference (Net)|3.2||||0.012|TWO_SIDED|||||Actual p value results above; Not adjusted due to pilot study aim to generate effect size comparing pre and posttest data|t-test, 2 sided|||Paired t tests of pre and posttest data||||0.012
72628983|NCT05098158|144785803|EQUIVALENCE|Paired t tests had .05 set as level of significance to reject null hypothesis. Sample powered to generate effect size for future studies.|Mean Difference (Net)|0.3||||0.811|TWO_SIDED|||||Actual p value results above; Not adjusted due to pilot study aim to generate effect size comparing pre and posttest data|t-test, 2 sided|||||||0.811
72628984|NCT05098158|144785804|EQUIVALENCE|Paired t tests had .05 set as level of significance to reject null hypothesis. Sample powered to generate effect size for future studies.|Mean Difference (Final Values)|0.1||||0.941|TWO_SIDED|||||Actual p value results above; Not adjusted due to pilot study aim to generate effect size comparing pre and posttest data|t-test, 2 sided|||Paired t tests of pre and posttest dat||||0.941
72628985|NCT05098158|144785805|OTHER|Descriptive statistics to report the percentage of offered telehealth sessions that were attended \[#attended/#offered = % attended\]|percentage|95.8|||||TWO_SIDED|||||||||||||
72628986|NCT03776812|144785807|OTHER||Hazard Ratio (HR)|0.83||||0.3293|TWO_SIDED|95.0|0.56|1.22|||Cox proportional hazards model|||||1.22|0.56|0.3293
72628987|NCT03776812|144785807|OTHER||Hazard Ratio (HR)|0.66||||0.0384|TWO_SIDED|95.0|0.44|0.98|||Cox proportional hazards model|||||0.98|0.44|0.0384
72628988|NCT01013649|144785832|SUPERIORITY||Hazard Ratio (HR)|1.04||||0.62|TWO_SIDED|95.0|0.79|1.38||One-sided significance level = 0.15|Log Rank||Reference level = Arm I|A total of 200 deaths between the arms will provide 80% power to detect a signal for an increase in median overall survival from 22 to 28.8 months and 90% power to detect a signal for an increase in median overall survival from 22 to 30.6 months (HRs of 0.76 and 0.72, respectively, in favor of the erlotinib arm) with the addition of erlotinib and a 1-sided alpha of 0.15||1.38|0.79|0.62
72628989|NCT01013649|144785833|SUPERIORITY||Hazard Ratio (HR)|0.96||||0.38|TWO_SIDED|90.0|0.79|1.18||One-sided significance level = 0.05.|Log Rank||Reference level = Arm III|316 deaths from step 2 randomized patients provides 80% power, with 0.05 1-sided alpha, to detect an OS increase (HR=0.76 in favor of arm IV), corresponding to increasing median OS from 17 to 22.5 months with the addition of RT. For analysis triggered by patients having 5 years potential follow-up from step 2 randomization, it is projected that at least 265 events will be observed, providing at least 72% power. The trigger used for the primary analysis was 5-years of follow-up (270 deaths).||1.18|0.79|0.38
72628990|NCT01013649|144785834|SUPERIORITY||Hazard Ratio (HR)|1.02|||||TWO_SIDED|95.0|0.8|1.31|||||Reference level = Arm I|||1.31|0.80|
72421514|NCT01342458|144354199|SUPERIORITY_OR_OTHER||Effect size|1.58|||<|0.001|TWO_SIDED||||||post hoc Newman-Keuls|||From baseline to 6th month.||||<0.001
72628991|NCT01013649|144785835|SUPERIORITY||Hazard Ratio (HR)|0.82|||||TWO_SIDED|90.0|0.68|0.99|||||Reference level = Arm III|||0.99|0.68|
72628992|NCT04285567|144785841|SUPERIORITY||Difference in Rates|26.6||||0.0004|TWO_SIDED|95.0|12.33|40.87|||Cochran-Mantel-Haenszel||95% CI for difference in rates were constructed using Anderson-Hauck method.|P-value estimated using Cochran-Mantel-Haenszel (CMH) test stratified by the IvRS randomization stratification factors.||40.87|12.33|0.0004
72628993|NCT04285567|144785843|SUPERIORITY||Difference in Rates|20.78||||0.0053|TWO_SIDED|95.0|6.66|34.9|||Cochran-Mantel-Haenszel||95% CI for difference in rates were constructed using Anderson-Hauck method.|P-value estimated using CMH test stratified by the IvRS randomization stratification factors.||34.90|6.66|0.0053
72628994|NCT04285567|144785844|SUPERIORITY||Difference in Rates|31.63|||<|0.0001|TWO_SIDED|95.0|16.55|46.71|||Cochran-Mantel-Haenszel||95% CI for difference in rates were constructed using Anderson-Hauck method.|P-value estimated using CMH test stratified by the IvRS randomization stratification factors.||46.71|16.55|< .0001
72628995|NCT04285567|144785845|SUPERIORITY||Difference in Response Rates|9.68||||0.1119|TWO_SIDED|95.0|-2.05|21.41|||Cochran-Mantel-Haenszel||95% CI for difference in rates were constructed using Anderson-Hauck method.|P-value estimated using CMH test stratified by the IvRS randomization stratification factors.||21.41|-2.05|0.1119
72628996|NCT04285567|144785846|SUPERIORITY||Difference in Response Rates|17.44||||0.0154|TWO_SIDED|95.0|1.96|32.93|||Cochran-Mantel-Haenszel||95% CI for difference in rates were constructed using Anderson-Hauck method.|P-value estimated using CMH test stratified by the IvRS randomization stratification factors.||32.93|1.96|0.0154
72628997|NCT04285567|144785847|SUPERIORITY||Difference in Rates|18.93||||0.0054|TWO_SIDED|95.0|0.91|36.95|||Cochran-Mantel-Haenszel||95% CI for difference in rates were constructed using Anderson-Hauck method.|P-value estimated using CMH test stratified by the IvRS randomization stratification factors.||36.95|0.91|0.0054
72628998|NCT04285567|144785848|SUPERIORITY||Difference in Rates|26.79||||0.0038|TWO_SIDED|95.0|3.86|49.72|||Cochran-Mantel-Haenszel||95% CI for difference in rates were constructed using Anderson-Hauck method.|P-value estimated using CMH test stratified by the IvRS randomization stratification factors.||49.72|3.86|0.0038
72329442|NCT03037476|144184382|OTHER|General Linear Model|Slope|-0.042||||0.552|TWO_SIDED|95.0|-0.18|0.097|||Mixed Models Analysis|Poisson Regression||Change in Past 12 Month Alcohol Use from Baseline to 6 Month Followup||.097|-.180|.552
72410725|NCT01175824|144329914|SUPERIORITY_OR_OTHER||LS mean difference|-0.22|||||TWO_SIDED|95.0|-0.39|-0.05||||Superiority will be concluded if of 95% CI upper limit for treatment difference (2x-daily insulin lispro LM minus the comparator arm) at 24 wks is \<0%||||-0.05|-0.39|
72410726|NCT00924950|144329915|SUPERIORITY||Mean Difference (Final Values)|0.8571||||0.0008|TWO_SIDED||||||t-test, 2 sided|||||||0.0008
72410727|NCT04193202|144329917|SUPERIORITY||Estimated difference|0.75||||0.034|TWO_SIDED|95.0|0.06|1.44|||Longitudinal ANCOVA|The model included terms for treatment group, visit, interaction of treatment by visit, gender, and baseline LCQ total score.|The estimated difference is the treatment difference in model based mean change from baseline at Week 12|||1.44|0.06|0.034
72410728|NCT04193202|144329918|OTHER||Estimated Difference|-6.92||||0.006|TWO_SIDED|95.0|-11.88|-1.97||Nominal p value, not controlled for multiplicity|Longitudinal ANCOVA|The model included terms for treatment group, visit, interaction of treatment by visit, gender, and baseline mean weekly cough severity VAS score.|The estimated difference is the treatment difference in model based mean change from baseline at Week 12.|||-1.97|-11.88|0.006
72410729|NCT02979535|144329921|OTHER||GMT ratio|0.947|||||TWO_SIDED|95.0|0.773|1.16||||||Antigen HPV-16||1.16|0.773|
72410730|NCT02979535|144329921|OTHER||GMT ratio|0.986|||||TWO_SIDED|95.0|0.803|1.21||||||Antigen HPV-18||1.21|0.803|
72410731|NCT02979535|144329922|OTHER||GMT ratio|0.977|||||TWO_SIDED|95.0|0.653|1.46||||||Dengue Virus Serotype 1||1.46|0.653|
72542941|NCT00931385|144615973|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.186|STANDARD_ERROR_OF_MEAN|0.028|<|0.0001||95.0|0.132|0.241|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Olo 5 mcg qd minus Placebo|||0.241|0.132|<0.0001
72410732|NCT02979535|144329922|OTHER||GMT ratio|0.911|||||TWO_SIDED|95.0|0.654|1.27||||||Dengue Virus Serotype 2||1.27|0.654|
72542942|NCT00931385|144615973|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|0.028|<|0.0001||95.0|0.145|0.254|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Olo 10 mcg qd minus Placebo|||0.254|0.145|<0.0001
72542943|NCT00931385|144615973|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.227|STANDARD_ERROR_OF_MEAN|0.028|<|0.0001||95.0|0.172|0.282|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Form 12 mcg bid minus Placebo|||0.282|0.172|<0.0001
72542944|NCT00931385|144615974|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.261|STANDARD_ERROR_OF_MEAN|0.035|<|0.0001||95.0|0.191|0.33|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Olo 5 mcg qd minus Placebo|||0.330|0.191|<0.0001
72542945|NCT00931385|144615974|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.252|STANDARD_ERROR_OF_MEAN|0.036|<|0.0001||95.0|0.183|0.322|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Olo 10 mcg qd minus Placebo|||0.322|0.183|<0.0001
72542946|NCT00931385|144615974|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.302|STANDARD_ERROR_OF_MEAN|0.036|<|0.0001||95.0|0.232|0.372|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Form 12 mcg bid minus Placebo|||0.372|0.232|<0.0001
72577508|NCT04841577|144682058|OTHER||Adjusted group GMT ratio|1.28|||||TWO_SIDED|95.0|1.09|1.51||||||Adjusted ratios of Control group over Co-Ad Group in RSV-B Neutralizing antibody GMTs at one month after RSV\_PreF3 OA investigational vaccination. An Analysis of Covariance (ANCOVA) model was used to analyse post-vaccination log-transformed titers of RSV-B neutralizing antibodies. The ANCOVA model included the treatment group, the age category (age at vaccination: 60-69, 70-79 or \>=80 years), country and sex as fixed effects and the pre-dose log-10 titer as covariate.||1.51|1.09|
72577509|NCT00182325|144682068|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
72410733|NCT02979535|144329922|OTHER||GMT ratio|0.921|||||TWO_SIDED|95.0|0.727|1.17||||||Dengue Virus Serotype 3||1.17|0.727|
72410734|NCT02979535|144329922|OTHER||GMT ratio|0.931|||||TWO_SIDED|95.0|0.733|1.18||||||Dengue Virus Serotype 4||1.18|0.733|
72410735|NCT04820673|144329942|OTHER||||||<|0.0001||||||P\<0.0001, calculated by t-test, corresponds to baseline response group domain scores in comparison to week-12 domain scores (CFB). CFB is calculated using available matching data for each domain. Higher domain scores indicate higher disease burden.|t-test, 2 sided|||Week 12 vs Baseline||||<.0001
72410736|NCT00767000|144329962|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.51|||<|0.001||95.0|-0.8|-0.22|||Constrained longitudinal model|||Analysis for change from baseline to Week 14||-0.22|-0.80|<0.001
72410737|NCT00767000|144329962|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.64|||<|0.001||95.0|-0.93|-0.36|||Constrained longitudinal model|||Analysis for change from baseline to Week 14||-0.36|-0.93|<0.001
72410738|NCT00767000|144329962|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.81|||<|0.001||95.0|-1.1|-0.53|||Contrained longitudinal model|||Analysis for change from baseline to Week 14||-0.53|-1.10|<0.001
72410739|NCT00767000|144329962|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.75|||<|0.001||95.0|-1.04|-0.46|||Constrained longitudinal model|||Analysis for change from baseline to Week 14||-0.46|-1.04|<0.001
72410740|NCT00767000|144329963|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-36.6|||<|0.001||95.0|-55.6|-17.5|||Constrained longitudial model|||Analysis for change from baseline to Week 14||-17.5|-55.6|<0.001
72542947|NCT00931385|144615975|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.154|STANDARD_ERROR_OF_MEAN|0.034|<|0.0001||95.0|0.087|0.221|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Olo 5 mcg qd minus Placebo|||0.221|0.087|<0.0001
72542948|NCT00931385|144615975|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.154|STANDARD_ERROR_OF_MEAN|0.034|<|0.0001||95.0|0.086|0.221|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Olo 10 mcg qd minus Placebo|||0.221|0.086|<0.0001
72542949|NCT00931385|144615975|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.183|STANDARD_ERROR_OF_MEAN|0.034|<|0.0001||95.0|0.115|0.25|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Form 12 mcg bid minus Placebo|||0.250|0.115|<0.0001
72542950|NCT01364259|144616007|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.0||||0.175|TWO_SIDED||||||Fisher Exact||Our odds ratio is equal to 0\*5/9\*2 because we have a zero cell in the two by two table. Hence the OR = 0.|||||0.175
72577510|NCT00182325|144682069|SUPERIORITY|||||||0.84|||||||t-test, 2 sided|||||||0.84
72421515|NCT01342458|144354199|SUPERIORITY_OR_OTHER||Effect size|0.68|||<|0.001|TWO_SIDED||||||post hoc Newman-Keuls|||From baseline to 3rd month.||||<0.001
72542951|NCT04444752|144616008|SUPERIORITY|Pairwise comparisons for each CBP-201 group vs placebo were performed and a serial gate-keeping procedure was used for multiplicity adjustment. Each CBP-201 group was compared to placebo group in order from highest dose (300 mg Q2W) to the lowest dose frequency (300 mg Q4W), until statistical signficance at p=0.05 level was not achieved.|Mean Difference (Final Values)|23.36|STANDARD_ERROR_OF_MEAN|6.794||0.0007|TWO_SIDED|||||Adjusted for multiplicity using a serial gatekeeping procedure at the 5% in descending order: 1. 300 mg dose Q2W 2. 150 mg dose Q2W 3. 300 mg dose Q4W vs placebo|ANCOVA|The data were analyzed using an ANCOVA model adjusted for treatment, baseline vIGA (moderate, severe), and baseline EASI.||"The primary efficacy analysis includes comparison of percentage reduction in EASI from baseline to Week 16 for CBP-201 300 mg Q2W regimen vs placebo.~The sample size of the study was determined based on power calculations for the primary endpoint in patients receiving CBP-201 300 mg Q2W.~Null hypothesis: CBP-201 300 Q2W is not superior to placebo in terms of percent reduction in EASI Score from Baseline to Week 16."||||0.0007
72542952|NCT04444752|144616008|SUPERIORITY|Pairwise comparisons for each CBP-201 group vs placebo were performed and a serial gatekeeping procedure was used for multiplicity adjustment. Each CBP-201 group was compared with the placebo group in order from the highest dose (300 mg Q2W) to the lowest dose frequency (300 mg Q4W), until statistical significance at 0.05 level was not achieved.|Mean Difference (Final Values)|17.89|STANDARD_ERROR_OF_MEAN|6.537||0.0067|TWO_SIDED|||||Adjusted for multiplicity using a serial gatekeeping procedure at the 5% in descending order: 1. 300 mg dose Q2W 2. 150 mg Q2W 3. 300 mg Q4W vs placebo.|ANCOVA|The data were analyzed using an ANCOVA model with terms for treatment, baseline vIGA (moderate, severe), and baseline EASI.||"The sample size of the study was determined based on power calculations for the primary endpoint in patients receiving CBP-201 300 mg Q2W.~Null hypothesis: CBP-201 150 Q2W is not superior to placebo in terms of percent reduction in EASI Score from Baseline to Week 16."||||0.0067
72542953|NCT04444752|144616008|SUPERIORITY|Pairwise comparisons for each CBP-201 group vs placebo were performed and a serial gatekeeping procedure was used for multiplicity adjustment. Each CBP-201 group was compared with placebo in order from highest dose (300 mg Q2W) to the lowest dose frequency (300 mg Q4W), until statistical significance at the 0.05 level was not achieved.|Mean Difference (Final Values)|23.83|STANDARD_ERROR_OF_MEAN|6.575||0.0004|TWO_SIDED|||||Adjusted for mulitplicity using a serial gatekeeping procedure at the 5% in descending order: 1. 300 mg dose Q2W 2. 150 mg Q2W 3. 300 mg Q4W vs placebo.|ANCOVA|The data were anlayzed using an ANCOVA model with terms for treatment, baseline vIGA (moderate, severe), and baseline EASI||"The efficacy analysis includes comparing percentage reduction in EASI from baseline to Week 16 for CBP-201 300 mg Q4W regimen vs placebo.~The sample size of the study was determined based on power calculations for the primary endpoint in patients receiving CBP-201 300 mg Q2W.~Null hypothesis: CBP-201 300 Q4W is not superior to placebo in terms of percent reduction in EASI Score from Baseline to Week 16."||||0.0004
72542954|NCT04444752|144616009|SUPERIORITY|The secondary efficacy analysis includes comparison of the number of patients achieving a vIGA score of 0/1 (clear/almost clear) at Week 16 for each CBP-201 300 mg Q2W vs placebo.|Difference in vIGA Response Rate|28.1||||0.0089|TWO_SIDED|||||There were no adjustments for multiple comparisons. For IGA response, counts, percentage, and 95% CIs obtained using the Clopper-Pearson method and were presented for pairwise comparisons for each CBP-201 group vs. placebo.|Chi-squared|||Null hypothesis: CBP-201 300 Q2W is not superior to placebo in terms of the number of patients achieving a vIGA score of 0/1 (clear/almost clear) at Week 16.||||0.0089
72542955|NCT02270983|144616014|SUPERIORITY||Least squares mean difference|1.325|STANDARD_ERROR_OF_MEAN|0.45||0.0035|TWO_SIDED|95.0|0.439|2.211|||ANCOVA|||||2.211|0.439|0.0035
72542956|NCT02270983|144616014|SUPERIORITY||Least squares mean difference|1.908|STANDARD_ERROR_OF_MEAN|0.451|<|0.0001|TWO_SIDED|95.0|1.021|2.796|||ANCOVA|||||2.796|1.021|<0.0001
72542957|NCT02270983|144616015|SUPERIORITY||Cox Proportional Hazard|1.28||||0.1429|TWO_SIDED|95.0|0.92|1.77|||Log Rank|||||1.77|0.92|0.1429
72542958|NCT02270983|144616015|SUPERIORITY||Cox Proportional Hazard|1.43||||0.0287|TWO_SIDED|95.0|1.04|1.97|||Log Rank|||||1.97|1.04|0.0287
72542959|NCT02270983|144616016|SUPERIORITY||Odds Ratio (OR)|1.37||||0.3332|TWO_SIDED|95.0|0.73|2.58|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel tests comparing specified treatment groups, controlling for geographic region.||||2.58|0.73|0.3332
72542960|NCT02270983|144616016|SUPERIORITY||Odds Ratio (OR)|1.92||||0.0506|TWO_SIDED|95.0|1.0|3.68|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel tests comparing specified treatment groups, controlling for geographic region.||||3.68|1.00|0.0506
72542961|NCT02270983|144616017|SUPERIORITY||Least squares mean difference|0.751|STANDARD_ERROR_OF_MEAN|0.217||0.0007|TWO_SIDED|95.0|0.324|1.178|||ANCOVA|||||1.178|0.324|0.0007
72542962|NCT02270983|144616017|SUPERIORITY||Least squares mean difference|0.987|STANDARD_ERROR_OF_MEAN|0.217|<|0.0001|TWO_SIDED|95.0|0.558|1.416|||ANCOVA|||||1.416|0.558|<0.0001
72542963|NCT02270983|144616018|SUPERIORITY||Least squares mean difference|-0.46|STANDARD_ERROR_OF_MEAN|0.145||0.0017|TWO_SIDED|95.0|-0.746|-0.174|||ANCOVA|||||-0.174|-0.746|0.0017
72542964|NCT02270983|144616018|SUPERIORITY||Least squares mean difference|-0.669|STANDARD_ERROR_OF_MEAN|0.146|<|0.0001|TWO_SIDED|95.0|-0.957|-0.382|||ANCOVA|||||-0.382|-0.957|<0.0001
72542965|NCT02270983|144616019|SUPERIORITY||Least squares mean difference|0.033|STANDARD_ERROR_OF_MEAN|0.205||0.872|TWO_SIDED|95.0|-0.371|0.437|||ANCOVA|||||0.437|-0.371|0.8720
72542966|NCT02270983|144616019|SUPERIORITY||Least squares mean difference|-0.607|STANDARD_ERROR_OF_MEAN|0.205||0.0034|TWO_SIDED|95.0|-1.011|-0.203|||ANCOVA|||||-0.203|-1.011|0.0034
72542967|NCT00740727|144616056|SUPERIORITY_OR_OTHER||% of subjects with infusion pain|11.1||||||95.0|1.4|34.7|||95% binomial exact confidence interval|||This analysis reports the number of subjects (of 18 possible) who experienced pain, during EASI placement or infusion, at the a priori-defined level of at least 3 on a 10-point pain scale.||34.7|1.4|
72577511|NCT00182325|144682070|SUPERIORITY|||||||0.68|||||||t-test, 2 sided|||||||0.68
72577512|NCT00182325|144682071|SUPERIORITY|||||||0.67|||||||t-test, 2 sided|||||||0.67
72577513|NCT00182325|144682072|SUPERIORITY|||||||0.57|||||||t-test, 2 sided|||||||0.57
72577514|NCT00182325|144682073|SUPERIORITY|||||||0.17|||||||t-test, 2 sided|||||||0.17
72577515|NCT00182325|144682074|SUPERIORITY|||||||0.46|||||||t-test, 2 sided|||||||0.46
72577516|NCT00182325|144682075|SUPERIORITY|||||||0.57|||||||t-test, 2 sided|||||||0.57
72577517|NCT00182325|144682076|SUPERIORITY|||||||0.26|||||||t-test, 2 sided|||||||0.26
72577518|NCT00182325|144682077|SUPERIORITY|||||||0.12|||||||t-test, 2 sided|||||||0.12
72628999|NCT04285567|144785850|SUPERIORITY||Difference in Response Rates|3.05||||0.4199|TWO_SIDED|95.0|-5.73|11.84|||Cochran-Mantel-Haenszel||95% CI for difference in rates were constructed using Anderson-Hauck method.|P-value estimated using CMH test stratified by the IvRS randomization stratification factors.||11.84|-5.73|0.4199
72629000|NCT04758637|144785859|SUPERIORITY||Mean Difference (Final Values)|7.62||||0|TWO_SIDED|95.0|2.4|13.59||The calculated p-value is 7.62E-10.|Zero-inflated Poisson mixed regression|Model estimates were used to derive estimated difference in difference value. Confidence intervals were bootstrapped using 1000 repetitions.||Null hypothesis is the difference in difference in estimated mean pill counts from the last week of baseline (week 26) to the last week of the intervention period (week 53) between control and non-fatal is 0.||13.59|2.4|0
72629001|NCT04758637|144785859|SUPERIORITY||Mean Difference (Final Values)|-14.65||||0|TWO_SIDED|95.0|-25.14|-6.97||The calculated p-value is 2E-16.|Zero-inflated Poisson mixed regression|Model estimates were used to derive estimated difference in difference value. Confidence intervals were bootstrapped using 1000 repetitions.||Null hypothesis is the difference in difference in estimated means from the study start (week 0) to the study end (week 23) between control and fatal is 0.||-6.97|-25.14|0
72629002|NCT04758637|144785860|SUPERIORITY||Slope|0.72||||0.219|TWO_SIDED|95.0|-0.43|1.86|||Regression, Logistic|||||1.86|-0.43|0.219
72629003|NCT04758637|144785860|SUPERIORITY||Slope|-0.72||||0.229|TWO_SIDED|95.0|-1.9|0.46|||Regression, Logistic|||||0.46|-1.9|0.229
72629004|NCT04183283|144785904|SUPERIORITY||Mean Difference (Final Values)|2.49||||0.75|TWO_SIDED|90.0|-10.66|15.65|||ANOVA|||Ring/CA conc: Vehicle, Type: ROI||15.65|-10.66|0.75
72577519|NCT01890434|144682112|SUPERIORITY||Sensitivity Difference|16.7||||9e-05|ONE_SIDED|95.0|9.3||||McNemar|McNemar one-sided test at alpha level of 5%||Sensitivity of gadobutrol-enhanced CMRI was compared with sensitivity of unenhanced CMRI evaluated by Reader 1.|||9.3|0.00009
72577520|NCT01890434|144682112|SUPERIORITY||Sensitivity Difference|26.0|||<|0.0001|ONE_SIDED|95.0|18.2||||McNemar|McNemar one-sided test at alpha level of 5%||Sensitivity of gadobutrol-enhanced CMRI was compared with sensitivity of unenhanced CMRI evaluated by Reader 2.|||18.2|<0.0001
72577521|NCT01890434|144682112|SUPERIORITY||Sensitivity Difference|32.0|||<|0.0001|ONE_SIDED|95.0|24.5||||McNemar|McNemar one-sided test at alpha level of 5%||Sensitivity of gadobutrol-enhanced CMRI was compared with sensitivity of unenhanced CMRI evaluated by Reader 3.|||24.5|<0.0001
72577522|NCT01890434|144682113|SUPERIORITY||Sensitivity Difference|21.0||||5e-05|ONE_SIDED|95.0|12.1||||McNemar|McNemar one-sided test at alpha level of 2.5%||Sensitivity of gadobutrol-enhanced CMRI was compared with sensitivity of unenhanced CMRI evaluated by Reader 1.|||12.1|0.00005
72577523|NCT01890434|144682113|SUPERIORITY||Sensitivity Difference|36.2|||<|0.0001|ONE_SIDED|95.0|26.3||||McNemar|McNemar one-sided test at alpha level of 2.5%||Sensitivity of gadobutrol-enhanced CMRI was compared with sensitivity of unenhanced CMRI evaluated by Reader 2.|||26.3|<0.0001
72577524|NCT01890434|144682113|SUPERIORITY||Sensitivity Difference|41.0|||<|0.0001|ONE_SIDED|95.0|31.8||||McNemar|McNemar one-sided test at alpha level of 2.5%||Sensitivity of gadobutrol-enhanced CMRI was compared with sensitivity of unenhanced CMRI evaluated by Reader 3.|||31.8|<0.0001
72577525|NCT01890434|144682118|SUPERIORITY||Sensitivity Difference|21.3|||<|0.0001|TWO_SIDED|95.0|12.9|28.4|||McNemar|McNemar 2-sided test at alpha level of 5%||Sensitivity of gadobutrol-enhanced CMRI was compared with sensitivity of unenhanced CMRI.||28.4|12.9|<0.0001
72577526|NCT01890434|144682118|SUPERIORITY||Sensitivity Difference|21.3|||<|0.0001|TWO_SIDED|90.0|14.2|27.2|||McNemar|McNemar 2-sided test at alpha level of 10%||||27.2|14.2|<0.0001
72577527|NCT01890434|144682120|NON_INFERIORITY|A non-inferiority margin was set as 15%|Sensitivity Difference|5.7||||0.2733|TWO_SIDED|95.0|-5.4|14.9|||McNemar|McNemar 2-sided test at alpha level of 5%||Sensitivity of gadobutrol-enhanced CMRI was compared with sensitivity of GSPECT evaluated by majority BR.||14.9|-5.4|0.2733
72577528|NCT01890434|144682120|NON_INFERIORITY|A non-inferiority margin was set as 15%.|Sensitivity Difference|0.0||||1|TWO_SIDED|95.0|-8.6|7.2|||McNemar|McNemar 2-sided test at alpha level of 5%||Sensitivity of gadobutrol-enhanced CMRI was compared with sensitivity of GSPECT evaluated by investigator.||7.2|-8.6|1.0000
72577529|NCT01890434|144682122|NON_INFERIORITY|A non-inferiority margin was set as 15%.|Specificity Difference|11.1||||0.001|TWO_SIDED|95.0|4.1|17.0|||McNemar|McNemar 2-sided test at alpha level of 5%||Specificity of gadobutrol-enhanced CMRI was compared with specificity of GSPECT by majority BR.||17.0|4.1|0.0010
72577530|NCT01890434|144682122|NON_INFERIORITY|A non-inferiority margin was set as 15%.|Specificity Difference|7.8||||0.0094|TWO_SIDED|95.0|1.6|13.2|||McNemar|McNemar 2-sided test at alpha level of 5%||Specificity of gadobutrol-enhanced CMRI was compared with specificity of GSPECT by investigator.||13.2|1.6|0.0094
72577531|NCT02257385|144682144|NON_INFERIORITY_OR_EQUIVALENCE|Alternate hypothesis:the difference between the trt means (umeclidinium/vilanterol minus indacaterol + tiotropium bromide) would be \> -50 milliliters (mL). If the lower CI (2.5% 1-sided significance level) of the statistical test should fall above -50 mL, then umeclidinium/vilanterol may be deemed statistically non-inferior to indacaterol plus tiotropium. If the lower CI (2.5% 1-sided significance) of the statistical testing exceeded 0 then, statistical superiority would have been established.|Least Squares Mean Difference|0.001||||0.964|TWO_SIDED|95.0|-0.029|0.03|||Mixed Models Analysis|||||0.030|-0.029|0.964
72577532|NCT02257385|144682145|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.023||||0.145|TWO_SIDED|95.0|-0.054|0.008|||Mixed Models Analysis|||||0.008|-0.054|0.145
72577533|NCT02686138|144682201|SUPERIORITY||Risk Difference (RD)|12.85|||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
72577534|NCT02686138|144682202|SUPERIORITY||Risk Difference (RD)|14.11|||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
72577535|NCT02686138|144682203|SUPERIORITY||Risk Difference (RD)|11.5||||0.004|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.004
72577536|NCT02686138|144682204|SUPERIORITY||Risk Difference (RD)|11.16||||0.003|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.003
72577537|NCT02686138|144682205|SUPERIORITY||Risk Difference (RD)|10.3||||0.01|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.01
72577538|NCT02686138|144682206|SUPERIORITY||Risk Difference (RD)|10.17||||0.013|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.013
72577539|NCT02686138|144682207|SUPERIORITY||Risk Difference (RD)|13.1|||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
72577540|NCT02686138|144682208|SUPERIORITY||Risk Difference (RD)|16.18|||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
72577541|NCT02686138|144682209|SUPERIORITY||Risk Difference (RD)|9.17||||0.015|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.015
72410741|NCT00767000|144329963|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-26.7||||0.005||95.0|-45.4|-8.1|||Constrained longitudinal model|||Analysis for change from baseline to Week 14||-8.1|-45.4|0.005
72410742|NCT00767000|144329963|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-35.0|||<|0.001||95.0|-54.0|-16.0|||Constrained longitudinal model|||Analysis for change from baseline to Week 14||-16.0|-54.0|<0.001
72410743|NCT00767000|144329963|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-36.9|||<|0.001||95.0|-55.9|-17.9|||Constrained longitudinal model|||Analysis for change from baseline to Week 14||-17.9|-55.9|<0.001
72577542|NCT02458287|144682230|SUPERIORITY_OR_OTHER||LS Mean Difference|-63.4|STANDARD_ERROR_OF_MEAN|4.4|<|0.001|TWO_SIDED|95.0|-72.0|-54.7|||Mixed Models Repeated Measures (MMRM)|||LS-mean difference, associated 95% confidence intervals, and p-value are from MMRM model with fixed effects for treatment groups, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction as covariates.||-54.7|-72.0|<0.001
72410744|NCT00767000|144329964|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|1.8||||0.791||95.0|-11.6|15.2|||Constrained longitudinal model|||Analysis for change from baseline to Week 14||15.2|-11.6|0.791
72410745|NCT00767000|144329964|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|10.3||||0.121||95.0|-2.7|23.2|||Constrained longitudinal model|||Analysis for change from baseline to Week 14||23.2|-2.7|0.121
72410746|NCT00767000|144329964|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-9.3||||0.169||95.0|-22.6|4.0|||Constrained longitudinal model|||Analysis for change from baseline to Week 14||4.0|-22.6|0.169
72410747|NCT00767000|144329964|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|6.7||||0.321||95.0|-6.6|20.0|||Constrained longitudinal model|||Analysis for change from baseline to Week 14||20.0|-6.6|0.321
72542968|NCT00740727|144616057|SUPERIORITY_OR_OTHER||% subjects with next-day EASI site pain|0.0||||||97.5|0.0|18.5|||binomial exact confidence interval|Because the point estimate was zero, the statistical software (STATA version 10MP) reports a one-sided 97.5% confidence interval.||This analysis reports the number of subjects (of 18 possible) who experienced pain, as assessed on next-day follow-up (24 hours after EASI infusion), at the a priori-defined level of at least 3 on a 10-point pain scale.||18.5|0|
72542969|NCT04364165|144616058|SUPERIORITY||Odds Ratio (OR)|2.0||||0.01|TWO_SIDED|95.0|1.44|2.78|||Regression, Logistic|||||2.78|1.44|.01
72542970|NCT04364165|144616059|SUPERIORITY||Odds Ratio (OR)|1.44||||0.41|TWO_SIDED|95.0|0.36|5.78|||Regression, Logistic|||||5.78|0.36|.41
72542971|NCT01473758|144616086|SUPERIORITY_OR_OTHER||LS Mean Difference|1.404|STANDARD_ERROR_OF_MEAN|3.07||0.6491|TWO_SIDED|95.0|-4.731|7.538||The model contains neutrophil count at Baseline and treatment as independent variables, fixed effects.|ANCOVA|||||7.538|-4.731|0.6491
72542972|NCT01473758|144616087|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.412|STANDARD_ERROR_OF_MEAN|2.687||0.8786|TWO_SIDED|95.0|-5.766|4.943||The model contains neutrophil count at Baseline and treatment as independent variables, fixed effects.|ANCOVA|||||4.943|-5.766|0.8786
72542973|NCT01677910|144616144|SUPERIORITY||Mean Difference (Net)|-0.81|||<|0.001|TWO_SIDED|95.0|-1.283|-0.337|||Wilcoxon rank sum||Mean difference is calculated as LX1606-Placebo|Primary analysis used a blocked 2-sample Wilcoxon rank sum statistic stratified by the urinary 5-HIAA stratification at randomization.||-0.337|-1.283|< 0.001
72542974|NCT01677910|144616144|SUPERIORITY||Mean Difference (Net)|-0.833|||<|0.001|TWO_SIDED|95.0|-1.292|-0.374|||Wilcoxon rank sum||Mean difference is calculated as LX1606-Placebo|Primary analysis used a blocked 2-sample Wilcoxon rank sum statistic stratified by the urinary 5-HIAA stratification at randomization.||-0.374|-1.292|< 0.001
72542975|NCT03341273|144616155|NON_INFERIORITY|The non-inferiority margin is 12.5%. Non-inferiority of placebo is concluded if the lower limit of the 95% confidence interval for the difference in proportions of clinical improvement is greater than -12.5%.|Risk Difference (RD)|-6.0|||||TWO_SIDED|95.0|-15.0|2.0||The null hypothesis was evaluated using a non-inferiority test and non-inferiority of placebo was concluded if the lower limit of the 95% confidence interval for the difference in proportions of clinical improvement was greater than -12.5%.|||Multiple imputation with a linear model to impute missing clinical values of improvement. The study day that D5V occurred on was included as a covariate in the final model and the estimates for risk difference assume that study day of D5V is 5.|Null Hypothesis: Proportion in placebo - Proportion in azithromycin = -12.5%||2|-15|
72542976|NCT03341273|144616156|NON_INFERIORITY|The non-inferiority margin is 12.5%. Non-inferiority of placebo is concluded if the lower limit of the 95% confidence interval for the difference in proportions of clinical improvement is greater than -12.5%.|Risk Difference (RD)|-4.0|||||TWO_SIDED|95.0|-12.0|3.0||The null hypothesis was evaluated using a non-inferiority test and non-inferiority of placebo was concluded if the lower limit of the 95% confidence interval for the difference in proportions of clinical improvement was greater than -12.5%.|||Multiple imputation with a linear model to impute missing clinical values of improvement. The study day that D11V occurred on was included as a covariate in the final model and the estimates for risk difference assume that study day of D11V is 11.|Null Hypothesis: Proportion in placebo - Proportion in azithromycin = -12.5%||3|-12|
72542977|NCT03341273|144616157|NON_INFERIORITY|The non-inferiority margin is 12.5%. Non-inferiority of placebo is concluded if the lower limit of the 95% confidence interval for the difference in proportions of clinical improvement is greater than -12.5%.|Risk Difference (RD)|-7.0|||||TWO_SIDED|95.0|-13.0|0.0||The null hypothesis was evaluated using a non-inferiority test and non-inferiority of placebo was concluded if the lower limit of the 95% confidence interval for the difference in proportions of clinical improvement was greater than -12.5%.|||Multiple imputation with a linear model to impute missing clinical values of improvement. The study day that D11V occurred on was included as a covariate in the final model and the estimates for risk difference assume that study day of D28V is 28.|Null Hypothesis: Proportion in placebo - Proportion in azithromycin = -12.5%||0|-13|
72410748|NCT02039505|144329978|SUPERIORITY||Adjusted Odds Ratio|1.37||||0.2722|TWO_SIDED|95.0|0.779|2.399|||Cochran-Mantel-Haenszel||Cochran-Mantel-Haenszel (CMH) test was used for analysis. Prior tumor necrosis factor alpha (TNFα) antagonist use (yes/no) was used as stratification factor.|||2.399|0.779|0.2722
72410749|NCT02039505|144329979|SUPERIORITY||Adjusted Odds Ratio|2.88||||0.021|TWO_SIDED|95.0|1.168|7.108|||Cochran-Mantel-Haenszel||CMH test was used for analysis. Prior TNFα antagonist use (yes/no) was used as stratification factor.|||7.108|1.168|0.0210
72421516|NCT01342458|144354199|SUPERIORITY_OR_OTHER||Effect size|0.42|||<|0.001|TWO_SIDED||||||post hoc Newman-Keuls|||From baseline to 6th month.||||<0.001
72629005|NCT04183283|144785904|SUPERIORITY||Mean Difference (Final Values)|-5.37||||0.5|TWO_SIDED|90.0|-18.49|7.76|||ANOVA|||Ring/CA conc: Vehicle, Type: ROI||7.76|-18.49|0.50
72629006|NCT04183283|144785904|SUPERIORITY||Mean Difference (Final Values)|1.68||||0.83|TWO_SIDED|90.0|-11.48|14.84|||ANOVA|||Ring/CA conc: Vehicle, Type: ROI||14.84|-11.48|0.83
72629007|NCT04183283|144785904|SUPERIORITY||Mean Difference (Final Values)|-0.88||||0.84|TWO_SIDED|90.0|-7.91|6.15|||ANOVA|||Ring/CA conc: Vehicle, Type: Entire Image||6.15|-7.91|0.84
72629008|NCT04183283|144785904|SUPERIORITY||Mean Difference (Final Values)|1.89||||0.66|TWO_SIDED|90.0|-5.13|8.9|||ANOVA|||Ring/CA conc: Vehicle, Type: Entire Image||8.90|-5.13|0.66
72629009|NCT04183283|144785904|SUPERIORITY||Mean Difference (Final Values)|0.65||||0.88|TWO_SIDED|90.0|-6.38|7.68|||ANOVA|||Ring/CA conc: Vehicle, Type: Entire Image||7.68|-6.38|0.88
72629010|NCT04183283|144785904|SUPERIORITY||Mean Difference (Final Values)|-53.83||||0.54|TWO_SIDED|90.0|-200.7|93.05|||ANOVA|||Ring/CA conc: 3% Type: ROI||93.05|-200.70|0.54
72629011|NCT04183283|144785904|SUPERIORITY||Mean Difference (Final Values)|-40.51||||0.65|TWO_SIDED|90.0|-187.01|105.98|||ANOVA|||Ring/CA conc: 3% Type: ROI||105.98|-187.01|0.65
72629012|NCT04183283|144785904|SUPERIORITY||Mean Difference (Final Values)|-52.99||||0.55|TWO_SIDED|90.0|-199.87|93.88|||ANOVA|||Ring/CA conc: 3% Type: ROI||93.88|-199.87|0.55
72629013|NCT04183283|144785904|SUPERIORITY||Mean Difference (Final Values)|-36.65||||0.18|TWO_SIDED|90.0|-81.85|8.56|||ANOVA|||Ring/CA conc: 3%, Type: Entire Image||8.56|-81.85|0.18
72629014|NCT04183283|144785904|SUPERIORITY||Mean Difference (Final Values)|-22.49||||0.41|TWO_SIDED|90.0|-67.58|22.59|||ANOVA|||Ring/CA conc: 3%, Type: Entire Image||22.59|-67.58|0.41
72629015|NCT04183283|144785904|SUPERIORITY||Mean Difference (Final Values)|-33.86||||0.22|TWO_SIDED|90.0|-79.06|11.34|||ANOVA|||Ring/CA conc: 3%, Type: Entire Image||11.34|-79.06|0.22
72629016|NCT04183283|144785904|SUPERIORITY||Mean Difference (Final Values)|-30.66||||0.74|TWO_SIDED|90.0|-183.08|121.76|||ANOVA|||Ring/CA conc: 10%, Type: ROI||121.76|-183.08|0.74
72629017|NCT04183283|144785904|SUPERIORITY||Mean Difference (Final Values)|-98.77||||0.28|TWO_SIDED|90.0|-250.79|53.25|||ANOVA|||Ring/CA conc: 10%, Type: ROI||53.25|-250.79|0.28
72629018|NCT04183283|144785904|SUPERIORITY||Mean Difference (Final Values)|-214.89||||0.02|TWO_SIDED|90.0|-367.31|-62.48|||ANOVA|||Ring/CA conc: 10%, Type: ROI||-62.48|-367.31|0.02
72629019|NCT04183283|144785904|SUPERIORITY||Mean Difference (Final Values)|-3.89||||0.93|TWO_SIDED|90.0|-81.44|73.66|||ANOVA|||Ring/CA conc: 10% , Type: Entire Image||73.66|-81.44|0.93
72629020|NCT04183283|144785904|SUPERIORITY||Mean Difference (Final Values)|-191.02|||<|0.0001|TWO_SIDED|90.0|-268.37|-113.67|||ANOVA|||Ring/CA conc: 10% , Type: Entire Image||-113.67|-268.37|<.0001
72629021|NCT04183283|144785904|SUPERIORITY||Mean Difference (Final Values)|-252.24|||<|0.0001|TWO_SIDED|90.0|-329.79|-174.68|||ANOVA|||Ring/CA conc: 10%, Type: Entire Image||-174.68|-329.79|<.0001
72629022|NCT04183283|144785905|SUPERIORITY||Mean Difference (Final Values)|-0.06||||0.99|TWO_SIDED|90.0|-8.28|8.15|||ANOVA|||Ring/CA conc: Vehicle, Type: ROI||8.15|-8.28|0.99
72629023|NCT04183283|144785905|SUPERIORITY||Mean Difference (Final Values)|-0.59||||0.91|TWO_SIDED|90.0|-8.78|7.6|||ANOVA|||Ring/CA conc: Vehicle, Type: ROI||7.60|-8.78|0.91
72629024|NCT04183283|144785905|SUPERIORITY||Mean Difference (Final Values)|2.53||||0.61|TWO_SIDED|90.0|-5.69|10.74|||ANOVA|||Ring/CA conc: Vehicle, Type: ROI||10.74|-5.69|0.61
72629025|NCT04183283|144785905|SUPERIORITY||Mean Difference (Final Values)|-1.29||||0.8|TWO_SIDED|90.0|-9.58|7.0|||ANOVA|||Ring/CA conc: Vehicle, Type: Entire Image||7.00|-9.58|0.80
72629026|NCT04183283|144785905|SUPERIORITY||Mean Difference (Final Values)|1.45||||0.77|TWO_SIDED|90.0|-6.83|9.72|||ANOVA|||Ring/CA conc: Vehicle, Type: Entire Image||9.72|-6.83|0.77
72629027|NCT04183283|144785905|SUPERIORITY||Mean Difference (Final Values)|1.85||||0.71|TWO_SIDED|90.0|-6.45|10.14|||ANOVA|||Ring/CA conc: Vehicle, Type: Entire Image||10.14|-6.45|0.71
72629028|NCT04183283|144785905|SUPERIORITY||Mean Difference (Final Values)|-18.38||||0.38|TWO_SIDED|90.0|-53.27|16.51|||ANOVA|||Ring/CA conc: 3%, Type: ROI||16.51|-53.27|0.38
72629029|NCT04183283|144785905|SUPERIORITY||Mean Difference (Final Values)|-2.97||||0.89|TWO_SIDED|90.0|-37.76|31.83|||ANOVA|||Ring/CA conc: 3%, Type: ROI||31.83|-37.76|0.89
72629030|NCT04183283|144785905|SUPERIORITY||Mean Difference (Final Values)|-10.12||||0.63|TWO_SIDED|90.0|-45.0|24.77|||ANOVA|||Ring/CA conc: 3%, Type: ROI||24.77|-45.00|0.63
72629031|NCT04183283|144785905|SUPERIORITY||Mean Difference (Final Values)|-11.31||||0.21|TWO_SIDED|90.0|-26.21|3.58|||ANOVA|||Ring/CA conc: 3%, Type: Entire Image||3.58|-26.21|0.21
72629032|NCT04183283|144785905|SUPERIORITY||Mean Difference (Final Values)|-3.19||||0.72|TWO_SIDED|90.0|-18.04|11.67|||ANOVA|||Ring/CA conc: 3%, Type: Entire Image||11.67|-18.04|0.72
72629033|NCT04183283|144785905|SUPERIORITY||Mean Difference (Final Values)|-10.46||||0.25|TWO_SIDED|90.0|-25.35|4.44|||ANOVA|||Ring/CA conc: 3%, Type: Entire Image||4.44|-25.35|0.25
72629034|NCT04183283|144785905|SUPERIORITY||Mean Difference (Final Values)|7.27||||0.69|TWO_SIDED|90.0|-22.71|37.25|||ANOVA|||Ring/CA conc: 10%, Type: ROI||37.25|-22.71|0.69
72629035|NCT04183283|144785905|SUPERIORITY||Mean Difference (Final Values)|-20.7||||0.25|TWO_SIDED|90.0|-50.6|9.2|||ANOVA|||Ring/CA conc: 10%, Type: ROI||9.2|-50.60|0.25
72629036|NCT04183283|144785905|SUPERIORITY||Mean Difference (Final Values)|-34.79||||0.06|TWO_SIDED|90.0|-64.77|-4.81|||ANOVA|||Ring/CA conc: 10%, Type: ROI||-4.81|-64.77|0.06
72629037|NCT04183283|144785905|SUPERIORITY||Mean Difference (Final Values)|10.01||||0.51|TWO_SIDED|90.0|-15.4|35.42|||ANOVA|||Ring/CA conc: 10% Type: Entire Image||35.42|-15.4|0.51
72629038|NCT04183283|144785905|SUPERIORITY||Mean Difference (Final Values)|-53.63|||<|0.001|TWO_SIDED|90.0|-78.98|-28.29|||ANOVA|||Ring/CA conc: 10% Type: Entire Image||-28.29|-78.98|<0.001
72629039|NCT04183283|144785905|SUPERIORITY||Mean Difference (Final Values)|-79.5|||<|0.0001|TWO_SIDED|90.0|-104.91|-54.09|||ANOVA|||Ring/CA conc: 10% Type: Entire Image||-54.09|-104.91|<.0001
72629040|NCT06005597|144785911|SUPERIORITY||Least Squares (LS) Means|-48.61|STANDARD_ERROR_OF_MEAN|4.959|<|0.0001|TWO_SIDED|95.0|-58.33|-38.89|||ANCOVA|||||-38.89|-58.33|<.0001
72629041|NCT06005597|144785912|SUPERIORITY||Least Squares (LS) Means|-27.94|STANDARD_ERROR_OF_MEAN|4.893|<|0.0001|TWO_SIDED|95.0|-37.53|-18.35|||ANCOVA|||||-18.35|-37.53|<.0001
72629042|NCT06005597|144785913|SUPERIORITY||Least Squares (LS) Means|-16.76|STANDARD_ERROR_OF_MEAN|4.918||0.0007|TWO_SIDED|95.0|-26.4|-7.12|||ANCOVA|||||-7.12|-26.40|0.0007
72629043|NCT06005597|144785914|SUPERIORITY||Least Squares (LS) Means|-31.85|STANDARD_ERROR_OF_MEAN|4.993|<|0.0001|TWO_SIDED|95.0|-41.64|-22.07|||ANCOVA|||||-22.07|-41.64|<.0001
72629044|NCT06005597|144785915|SUPERIORITY||Least Squares (LS) Means|-45.13|STANDARD_ERROR_OF_MEAN|4.233|<|0.0001|TWO_SIDED|95.0|-53.43|-36.84|||ANCOVA|||||-36.84|-53.43|<.0001
72629045|NCT06005597|144785916|SUPERIORITY||Least Squares (LS) Means|-29.19|STANDARD_ERROR_OF_MEAN|3.467|<|0.0001|TWO_SIDED|95.0|-35.99|-22.4|||ANCOVA|||||-22.40|-35.99|<.0001
72629046|NCT06005597|144785917|SUPERIORITY||Least Squares (LS) Means|-29.9|STANDARD_ERROR_OF_MEAN|4.274|<|0.0001|TWO_SIDED|95.0|-38.28|-21.53|||ANCOVA|||||-21.53|-38.28|<.0001
72629047|NCT06005597|144785918|SUPERIORITY||Least Squares (LS) Means|-19.78|STANDARD_ERROR_OF_MEAN|3.549|<|0.0001|TWO_SIDED|95.0|-26.73|-12.82|||ANCOVA|||||-12.82|-26.73|<.0001
72629048|NCT06005597|144785919|SUPERIORITY||Least Squares (LS) Means|-25.44|STANDARD_ERROR_OF_MEAN|4.198|<|0.0001|TWO_SIDED|95.0|-33.67|-17.22|||ANCOVA|||||-17.22|-33.67|<.0001
72577543|NCT02458287|144682239|SUPERIORITY_OR_OTHER||LS Mean Difference|-43.0|STANDARD_ERROR_OF_MEAN|4.53|<|0.001|TWO_SIDED|95.0|-51.9|-34.0|||MMRM|||LS-mean differences and associated 95% confidence intervals, and p-values are from an MMRM model with fixed effects for treatment groups, visit, treatment group \* visit interaction, baseline value, baseline value \* visit interaction as covariates.||-34.0|-51.9|<0.001
72629049|NCT06005597|144785920|SUPERIORITY||Least Squares (LS) Means|-14.21|STANDARD_ERROR_OF_MEAN|3.495|<|0.0001|TWO_SIDED|95.0|-21.06|-7.36|||ANCOVA|||||-7.36|-21.06|<.0001
72629050|NCT06005597|144785921|SUPERIORITY||Least Squares (LS) Means|-15.23|STANDARD_ERROR_OF_MEAN|4.236||0.0003|TWO_SIDED|95.0|-23.53|-6.93|||ANCOVA|||||-6.93|-23.53|0.0003
72629051|NCT06005597|144785922|SUPERIORITY||Least Squares (LS) Means|-9.42|STANDARD_ERROR_OF_MEAN|3.493||0.007|TWO_SIDED|95.0|-16.26|-2.57|||ANCOVA|||||-2.57|-16.26|0.007
72629052|NCT03375320|144785923|SUPERIORITY||||||<|0.0001|||||||One-sided unstratified log-rank|||||||<0.0001
72629053|NCT03375320|144785923|SUPERIORITY||||||<|0.0001|||||||One-sided unstratified log-rank|||||||<0.0001
72629054|NCT03375320|144785924|SUPERIORITY|||||||0.2438|||||||One-sided stratified log-rank|||||||0.2438
72629055|NCT03375320|144785924|SUPERIORITY|||||||0.4426|||||||One-sided stratified log-rank|||||||0.4426
72629056|NCT03375320|144785926|SUPERIORITY|||||||0.05|||||||Chi-squared|||||||0.05
72329443|NCT03037476|144184382|OTHER|General Linear Model|Slope|0.037||||0.608|TWO_SIDED|95.0|-0.104|0.177|||Mixed Models Analysis|Poisson Regression||Change in Past 12 Month Alcohol Use from Baseline to 12 Month Followup||.177|-.104|.608
72329444|NCT03037476|144184382|OTHER|General Linear Model|Slope|0.015||||0.84|TWO_SIDED|95.0|-0.13|0.16|||Mixed Models Analysis|Poisson Regression||Change in Past 12 Month Other Drug Use from Baseline to 6 Month Followup||.160|-.130|.840
72577544|NCT02458287|144682240|SUPERIORITY_OR_OTHER||LS Mean Difference|-39.7|STANDARD_ERROR_OF_MEAN|2.86|<|0.001|TWO_SIDED|95.0|-45.4|-34.1|||MMRM|||LS-mean differences and associated 95% confidence intervals, and p-values are from an MMRM model with fixed effects for treatment groups, visit, treatment group \* visit interaction, baseline value, baseline value \* visit interaction as covariates.||-34.1|-45.4|<0.001
72629057|NCT03375320|144785926|SUPERIORITY|||||||0.01|||||||Chi-squared|||||||0.01
72629058|NCT04323098|144785927|SUPERIORITY|||||||0.0057||||||P-value was based on two-sided t-test against 0.|t-test, 2 sided|||||||0.0057
72629059|NCT05611996|144785965|SUPERIORITY||Mean Difference (Net)|-1.783|STANDARD_ERROR_OF_MEAN|0.772||0.025|TWO_SIDED|95.0|-3.336|-0.23||The a priori threshold for statistical significance is p=0.05.|Mixed Models Analysis||Score difference = Post-intervention - Baseline|Null hypothesis: there is no difference in the mean Patient Health Questionnaire-9 (PHQ-9) scores from baseline to post-intervention for all study participants.||-0.230|-3.336|0.025
72629060|NCT05611996|144785965|SUPERIORITY||Mean Difference (Net)|-2.42|STANDARD_ERROR_OF_MEAN|0.814||0.005|TWO_SIDED|95.0|-4.057|-0.784||The a priori threshold for statistical significance is p=0.05.|Mixed Models Analysis||Score difference = 3-month - Baseline|Null hypothesis: there is no difference in the mean Patient Health Questionnaire-9 (PHQ-9) scores from baseline to 3-month for all study participants.||-0.784|-4.057|0.005
72629061|NCT05611996|144785965|SUPERIORITY||Mean Difference (Net)|-0.5468|STANDARD_ERROR_OF_MEAN|0.1744||0.004|TWO_SIDED|95.0|-0.9039|-0.1897||The a priori threshold for statistical significance is p=0.05.|Mixed Models Analysis||The mean difference of the PHQ-9 score by each unit increase of the time(each week increase)|Null hypothesis: There is no difference in the mean Patient Health Questionnaire-9 (PHQ-9) scores over time for all study participants.||-0.1897|-0.9039|0.0040
72629062|NCT04479475|144785975|OTHER|The Wilcoxon signed-rank test is a non-parametric statistical test. We used it to assess repeated measures of missed methadone doses.|Mean Difference (Final Values)|7.9|STANDARD_DEVIATION|10.8||0.0094|TWO_SIDED|||||Exact p-value reported due to small sample size|Wilcoxon signed-rank test||We opted not to include the 95% confidence interval due to the non-parametric nature of the data.|||||0.0094
72629063|NCT05879991|144785978|OTHER||Ratio of adjusted geometric means [%]|76.18|||||TWO_SIDED|90.0|70.21|82.65|||||Ratio \[%\] = (adjusted geometric mean zongertinib / adjusted geometric mean \[14C\]zongertinib)\*100. Intra-individual geometric coefficient of variation (gCV) \[%\] = 7.9|"Ratio of adjusted geometric means was calculated using an ANOVA model on the logarithmic scale.~The PK endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model, which included the effect 'subjects' as a random effect and 'treatment' as a fixed effect. These quantities were then back-transformed to the original scale."||82.65|70.21|
72629064|NCT05879991|144785983|OTHER||Ratio of adjusted geometric means [%]|26.1|||||TWO_SIDED|90.0|22.12|30.79|||||Ratio \[%\] = (adjusted geometric mean zongertinib / adjusted geometric mean \[14C\]zongertinib)\*100. Intra-individual geometric coefficient of variation (gCV) \[%\] = 16.0|Ratio of adjusted geometric means was calculated using an ANOVA model on the logarithmic scale. The PK endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model, which included the effect 'subjects' as a random effect and 'treatment' as a fixed effect. These quantities were then back-transformed to the original scale.||30.79|22.12|
72629065|NCT05879991|144785984|OTHER||Ratio of adjusted geometric means [%]|76.99|||||TWO_SIDED|90.0|70.92|83.59|||||Ratio \[%\] = (adjusted geometric mean zongertinib / adjusted geometric mean \[14C\]zongertinib)\*100. Intra-individual geometric coefficient of variation (gCV) \[%\] = 7.9|Ratio of adjusted geometric means was calculated using an ANOVA model on the logarithmic scale. The PK endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model, which included the effect 'subjects' as a random effect and 'treatment' as a fixed effect. These quantities were then back-transformed to the original scale.||83.59|70.92|
72629066|NCT05464069|144786041|SUPERIORITY|||||||0.16||||||Significant level \< 0.05|t-test, 2 sided|||||||0.160
72629067|NCT04572243|144786049|SUPERIORITY||Median Difference (Final Values)|-86.08|||||TWO_SIDED|95.0|-144.01|-28.14||||||||-28.14|-144.01|
72629068|NCT04572243|144786050|SUPERIORITY||Odds Ratio (OR)|6.0|||||TWO_SIDED|95.0|0.81|44.35||||||||44.35|0.81|
72629069|NCT04976192|144786070|OTHER||LS Mean Difference|-0.31|||||TWO_SIDED|95.0|-1.56|0.94||||||||0.94|-1.56|
72629070|NCT04976192|144786071|OTHER||LS Mean Difference|-0.39|||||TWO_SIDED|90.0|-1.37|0.58||||||||0.58|-1.37|
72629071|NCT04976192|144786071|OTHER||Relative Potency|0.89|||||||||||||Relative potency of TEV-45779 and XOLAIR is a co-primary efficacy endpoint for FDA submission.|The relative potency of the test drug to the reference drug was defined as the dose of the test drug that produced the same biological response as 1 unit of the dose of the reference drug. Relative potency was demonstrated if the 90% confidence interval (CI) for relative potency fell entirely within the equivalence margins.||||
72629072|NCT04073225|144786108|SUPERIORITY||Mean Difference (Net)|-33.8||||0.323|TWO_SIDED|95.0|-100.9|33.2|||Mixed Models Analysis|||Mixed effects models were fit including fixed effects for intervention arm, visit (baseline, 12 week) and intervention by visit interaction; and random intercepts and slopes for each participant.||33.2|-100.9|.323
72629073|NCT04073225|144786109|SUPERIORITY||Mean Difference (Net)|-81.3||||0.057|TWO_SIDED|95.0|-165.2|2.5|||Mixed Models Analysis|||Mixed effects models were fit including fixed effects for intervention arm, visit (baseline, 12 week) and intervention by visit interaction; and random intercepts and slopes for each participant.||2.5|-165.2|.057
72629074|NCT04073225|144786110|SUPERIORITY||Mean Difference (Net)|3.1||||0.047|TWO_SIDED|95.0|0.03|6.08|||Mixed Models Analysis|||Mixed effects models were fit including fixed effects for intervention arm, visit (baseline, 12 week) and intervention by visit interaction; and random intercepts and slopes for each participant.||6.08|0.03|.047
72629075|NCT04073225|144786111|SUPERIORITY||Mean Difference (Net)|0.59||||0.565|TWO_SIDED|95.0|-1.4|2.6|||Mixed Models Analysis|||Mixed effects models were fit including fixed effects for intervention arm, visit (baseline, 12 week) and intervention by visit interaction; and random intercepts and slopes for each participant.||2.6|-1.4|.565
72629076|NCT04073225|144786112|SUPERIORITY||Mean Difference (Net)|1.27|STANDARD_ERROR_OF_MEAN|0.825||0.147|TWO_SIDED|95.0|-0.5|3.03|||t-test, 2 sided|||||3.03|-0.50|0.147
72629077|NCT04073225|144786113|SUPERIORITY||Mean Difference (Net)|99.4||||0.605|TWO_SIDED|95.0|-334.3|533.0|||t-test, 2 sided|||We conducted t-tests of differences in volumetric change comparing intervention to control arms.||533.0|-334.3|.605
72629078|NCT04073225|144786114|SUPERIORITY||Mean Difference (Net)|130.8||||0.59|TWO_SIDED|95.0|-259.7|248.6|||t-test, 2 sided|||We conducted t-tests of differences in volumetric change comparing intervention to control arms.||248.6|-259.7|.590
72629079|NCT04073225|144786115|SUPERIORITY||Mean Difference (Net)|-24.72|STANDARD_ERROR_OF_MEAN|73.85||0.743|TWO_SIDED|95.0|-183.11|133.68|||t-test, 2 sided|||||133.68|-183.11|.743
72629080|NCT04073225|144786116|SUPERIORITY||Mean Difference (Net)|-1.1|STANDARD_ERROR_OF_MEAN|3.13||0.731|TWO_SIDED|95.0|-7.91|5.71|||t-test, 2 sided|||||5.71|-7.91|0.731
72629081|NCT00124306|144786257|SUPERIORITY||Mean Difference (Net)|-1.5|||||TWO_SIDED|95.0|-2.5|-0.5||||||IC Symptom Index - change from baseline to 12 weeks||-0.5|-2.5|
72629082|NCT00124306|144786257|SUPERIORITY||Mean Difference (Net)|-1.2|||||TWO_SIDED|95.0|-2.3|-0.2||||||IC Problem Index - change from baseline to 12 weeks||-0.2|-2.3|
72629083|NCT00124306|144786257|SUPERIORITY||Mean Difference (Net)|-3.8|||||TWO_SIDED|95.0|-6.3|-1.3||||||Wisconsin Symptom Survey - change from baseline to 12 weeks||-1.3|-6.3|
72629084|NCT02112916|144786260|SUPERIORITY||Hazard Ratio (HR)|0.782||||0.074|TWO_SIDED|95.0|0.561|1.091|||Log Rank||Hazard ratio = hazard rate for Arm B/hazard rate for Arm A|To compare the EFS of the randomized patients (T-ALL+T-LLy) on Arm A vs Arm B. Study was designed to accrue 1200 eligible, evaluable randomized patients (to provide 90.5% power to detect an improvement in 4-year EFS from 85% to 90% with an alpha of 0.05 (one-sided log-rank test) (Hazard Ratio (HR)=0.6483). Study was closed to accrual early due to results from AALL0434 for nelarabine.||1.091|0.561|0.074
72629085|NCT02999477|144786297|EQUIVALENCE|The null hypothesis is no change in the amount of PD-L1 expression from baseline to after a two-week run in of nabpaclitaxel. The test was using one-sided alpha (type I error) of 0.05. The margin is zero.||||||1|||||||McNemar|||||||1.0
72629086|NCT02999477|144786297|EQUIVALENCE|The null hypothesis is no change in the amount of PD-L1 expression from baseline to after a two-week run in of nabpaclitaxel or pembrolizumab. The test was using one-sided alpha (type I error) of 0.05.||||||1|||||||McNemar|||||||1.0
72629087|NCT04266795|144786305|SUPERIORITY||Hazard Ratio (HR)|0.99|||=|0.477|TWO_SIDED|95.0|0.61|1.6|||Log Rank|P-value was comparison of EFS between treatment groups and was based on the 1-sided stratified log-rank test statistic.|Hazard ratio was based on an unadjusted stratified Cox proportional hazard regression model with stratification factors (randomization strata of age and AML subtype) and treatment as a factor in the model.|||1.60|0.61|=0.477
72629088|NCT02655016|144786361|SUPERIORITY||Hazard Ratio (HR)|0.62|||<|0.0001|TWO_SIDED|95.0|0.502|0.755||p-value was calculated based on stratified log-rank test using randomization stratification factors: administration of neoadjuvant chemotherapy, best response to platinum therapy and homologous recombination deficiency (HRD) status.|Log Rank||If hazard ratio was found to be \<1 then niraparib can be considered as superior to placebo.|||0.755|0.502|<0.0001
72629089|NCT02655016|144786362|SUPERIORITY||Hazard Ratio (HR)|0.7||||0.1238|TWO_SIDED|95.0|0.442|1.106||p-value was calculated based on stratified log-rank test using randomization stratification factors: administration of neoadjuvant chemotherapy, best response to platinum therapy and HRD status.|Log Rank||If hazard ratio was found to be \<1 then niraparib can be considered as superior to placebo.|||1.106|0.442|0.1238
72629090|NCT02655016|144786363|SUPERIORITY||Hazard Ratio (HR)|0.65||||0.0001|TWO_SIDED|95.0|0.521|0.802||p-value was calculated based on stratified log-rank test using randomization stratification factors: administration of neoadjuvant chemotherapy, best response to platinum therapy and HRD status.|Log Rank||If hazard ratio was found to be \<1 then niraparib can be considered as superior to placebo.|||0.802|0.521|0.0001
72629091|NCT02655016|144786364|SUPERIORITY||Hazard Ratio (HR)|0.81||||0.2242|TWO_SIDED|95.0|0.577|1.139||p-value was calculated based on stratified log-rank test using randomization stratification factors: administration of neoadjuvant chemotherapy, best response to platinum therapy and HRD status.|Log Rank||If hazard ratio was found to be \<1 then niraparib can be considered as superior to placebo.|||1.139|0.577|0.2242
72629092|NCT03734029|144786431|SUPERIORITY||Cox Proportional Hazard|0.5085|||<|0.0001|TWO_SIDED|95.0|0.4012|0.6444||Two-sided p-value from stratified log-rank test, Hazard ratio and 95% CI from stratified Cox proportional hazards model using stratification factors: HER2 status, number of prior lines of chemotherapy, hormone Receptor/CDK status, as defined by IXRS.|Log Rank|||||0.6444|0.4012|<0.0001
72577545|NCT02458287|144682240|SUPERIORITY_OR_OTHER||LS Mean Difference|-26.7|STANDARD_ERROR_OF_MEAN|2.96|<|0.001|TWO_SIDED|95.0|-32.5|-20.8|||MMRM|||LS-mean differences and associated 95% confidence intervals, and p-values are from an MMRM model with fixed effects for treatment groups, visit, treatment group \* visit interaction, baseline value, baseline value \* visit interaction as covariates.||-20.8|-32.5|<0.001
72410750|NCT02039505|144329985|SUPERIORITY||Adjusted Odds Ratio|1.66||||0.198|TWO_SIDED|95.0|0.762|3.596|||Cochran-Mantel-Haenszel||CMH test was used for analysis. Prior TNFα antagonist use (yes/no) was used as stratification factor.|||3.596|0.762|0.1980
72629093|NCT04818034|144786443|OTHER|paired t-test|paired t-test|0.965|STANDARD_DEVIATION|37.0||0.965|ONE_SIDED|96.0|||||paired t-test|||||||0.965
72629094|NCT06946888|144786444|OTHER|A generalized estimating equation (GEE) model included group (intervention group vs. control group), week (categorical: 0-8), group × week interaction, and age as covariates. Robust (sandwich) standard errors were used. Regression coefficients (B), standard errors, Wald chi-squared statistics, 95% confidence intervals, and p-values for group × week comparisons are reported.||||||0.837||||||This is the first week of tracking. A P value \< 0.05 indicated a statistically significant difference.|Generalized Estimating Equations, GEE|Repeated-measures GEE was used to examine the group × time interaction between week 0 and week 1.||Generalized estimating equations (GEE) were chosen over repeated-measures analysis of variance or generalized linear mixed models because they provide estimates of the population mean, are robust to correlated error specifications, can accommodate missing data under the MAR/MCAR assumptions, and do not require sphericity. All tests were two-tailed, with α = 0.05.||||0.837
72629095|NCT06946888|144786444|OTHER|A generalized estimating equation (GEE) model included group (intervention group vs. control group), week (categorical: 0-8), group × week interaction, and age as covariates. Robust (sandwich) standard errors were used. Regression coefficients (B), standard errors, Wald chi-squared statistics, 95% confidence intervals, and p-values for group × week comparisons are reported.||||||0.428||||||This is the second week of tracking data. A P value \< 0.05 indicated a statistically significant difference.|Generalized Estimating Equations, GEE|Repeated-measures GEE was used to examine the group × time interaction between week 0 and week 2.||Generalized estimating equations (GEE) were chosen over repeated-measures analysis of variance or generalized linear mixed models because they provide estimates of the population mean, are robust to correlated error specifications, can accommodate missing data under the MAR/MCAR assumptions, and do not require sphericity. All tests were two-tailed, with α = 0.05.||||0.428
72629096|NCT06946888|144786444|OTHER|A generalized estimating equation (GEE) model included group (intervention group vs. control group), week (categorical: 0-8), group × week interaction, and age as covariates. Robust (sandwich) standard errors were used. Regression coefficients (B), standard errors, Wald chi-squared statistics, 95% confidence intervals, and p-values for group × week comparisons are reported.||||||0.269||||||This is the third week of tracking data. A P value \< 0.05 indicated a statistically significant difference.|Generalized Estimating Equations, GEE|Repeated-measures GEE was used to examine the group × time interaction between week 0 and week 3.||Generalized estimating equations (GEE) were chosen over repeated-measures analysis of variance or generalized linear mixed models because they provide estimates of the population mean, are robust to correlated error specifications, can accommodate missing data under the MAR/MCAR assumptions, and do not require sphericity. All tests were two-tailed, with α = 0.05.||||0.269
72629097|NCT06946888|144786444|OTHER|A generalized estimating equation (GEE) model included group (intervention group vs. control group), week (categorical: 0-8), group × week interaction, and age as covariates. Robust (sandwich) standard errors were used. Regression coefficients (B), standard errors, Wald chi-squared statistics, 95% confidence intervals, and p-values for group × week comparisons are reported.||||||0.015||||||This is the fourth week of tracking data. A P value \< 0.05 indicated a statistically significant difference.|Generalized Estimating Equations, GEE|Repeated-measures GEE was used to examine the group × time interaction between week 0 and week 4.||Generalized estimating equations (GEE) were chosen over repeated-measures analysis of variance or generalized linear mixed models because they provide estimates of the population mean, are robust to correlated error specifications, can accommodate missing data under the MAR/MCAR assumptions, and do not require sphericity. All tests were two-tailed, with α = 0.05.||||0.015
72629098|NCT06946888|144786444|OTHER|A generalized estimating equation (GEE) model included group (intervention group vs. control group), week (categorical: 0-8), group × week interaction, and age as covariates. Robust (sandwich) standard errors were used. Regression coefficients (B), standard errors, Wald chi-squared statistics, 95% confidence intervals, and p-values for group × week comparisons are reported.||||||0.163||||||This is the fifth week of tracking data. A P value \< 0.05 indicated a statistically significant difference.|Generalized Estimating Equations, GEE|Repeated-measures GEE was used to examine the group × time interaction between week 0 and week 5.||Generalized estimating equations (GEE) were chosen over repeated-measures analysis of variance or generalized linear mixed models because they provide estimates of the population mean, are robust to correlated error specifications, can accommodate missing data under the MAR/MCAR assumptions, and do not require sphericity. All tests were two-tailed, with α = 0.05.||||0.163
72329445|NCT03037476|144184382|OTHER|General Linear Model|Slope|0.007||||0.927|TWO_SIDED|95.0|-0.142|0.155|||Mixed Models Analysis|Poisson Regression||Change in Past 12 Month Other Drug Use from Baseline to 12 Month Followup||.155|-.142|.927
72410751|NCT02039505|144329986|SUPERIORITY||Adjusted Odds Ratio|1.33||||0.3168|TWO_SIDED|95.0|0.755|2.356|||Cochran-Mantel-Haenszel||CMH test was used for analysis. Prior TNFα antagonist use (yes/no) was used as stratification factor.|||2.356|0.755|0.3168
72577546|NCT02458287|144682241|SUPERIORITY_OR_OTHER||LS Mean Difference|-57.9|STANDARD_ERROR_OF_MEAN|4.25|<|0.001|TWO_SIDED|95.0|-66.2|-49.5|||MMRM|||LS-mean differences and associated 95% confidence intervals, and p-values are from an MMRM model with fixed effects for treatment groups, visit, treatment group \* visit interaction, baseline value, baseline value \* visit interaction as covariates.||-49.5|-66.2|<0.001
72577547|NCT02458287|144682241|SUPERIORITY_OR_OTHER||LS Mean Difference|-35.8|STANDARD_ERROR_OF_MEAN|4.38|<|0.001|TWO_SIDED|95.0|-44.4|-27.1|||MMRM|||LS-mean differences and associated 95% confidence intervals, and p-values are from an MMRM model with fixed effects for treatment groups, visit, treatment group \* visit interaction, baseline value, baseline value \* visit interaction as covariates.||-27.1|-44.4|<0.001
72577548|NCT02458287|144682242|SUPERIORITY_OR_OTHER||LS Mean Difference|-56.2|STANDARD_ERROR_OF_MEAN|3.84|<|0.001|TWO_SIDED|95.0|-63.7|-48.6|||MMRM|||LS-mean differences and associated 95% confidence intervals, and p-values are from an MMRM model with fixed effects for treatment groups, visit, treatment group \* visit interaction, baseline value, baseline value \* visit interaction as covariates.||-48.6|-63.7|<0.001
72577549|NCT02458287|144682242|SUPERIORITY_OR_OTHER||LS Mean Difference|-37.2|STANDARD_ERROR_OF_MEAN|3.99|<|0.001|TWO_SIDED|95.0|-45.0|-29.3|||MMRM|||LS-mean differences and associated 95% confidence intervals, and p-values are from an MMRM model with fixed effects for treatment groups, visit, treatment group \* visit interaction, baseline value, baseline value \* visit interaction as covariates.||-29.3|-45.0|<0.001
72577550|NCT02800642|144682276|OTHER||||||<|0.0001|||||||Exact one-sided 1-sample binomial test|||"The null hypothesis the proportion of participants with a ≥ 15-letter gain in BCVA at Week 76 is ≤ 40% on the 2.5% level of significance (one-sided) was performed using the following criterion: If the p value is less than 2.5%, the null hypothesis will be rejected. Otherwise, the null hypothesis will be regarded as not rejected and may still be true"||||<0.0001
72577551|NCT02800642|144682277|OTHER||||||=|0.8822|||||||Exact one-sided 1-sample binomial test|||"The null hypothesis the proportion of participants with a mean treatment interval of ≥ 8 weeks is ≤ 50% on the 2.5% level of significance (one-sided) was performed using the following criterion: If the p value is less than 2.5%, the null hypothesis will be rejected. Otherwise, the null hypothesis will be regarded as not rejected and may still be true"||||=0.8822
72577552|NCT01004003|144682286|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.437|||||TWO_SIDED|95.0|0.805|2.565|||||"Hazard ratio (HR) from Cox proportional hazards model stratified by macroscopic vacular invasion, extrahepatic spread, or both present vs both absent.~HR below 1 favors Nintedanib."|||2.565|0.805|
72577553|NCT01004003|144682289|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.351|||||TWO_SIDED|95.0|0.779|2.343|||||"Hazard ratio from Cox proportional hazards model stratified by macroscopic vacular invasion, extrahepatic spread, or both present vs both absent.~HR below 1 favors Nintedanib."|||2.343|0.779|
72577554|NCT01004003|144682290|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.877|||||TWO_SIDED|95.0|0.522|1.473|||||"Hazard ratio from Cox proportional hazards model stratified by macroscopic vacular invasion, extrahepatic spread, or both present vs both absent.~HR below 1 favors Nintedanib."|||1.473|0.522|
72629099|NCT06946888|144786444|OTHER|A generalized estimating equation (GEE) model included group (intervention group vs. control group), week (categorical: 0-8), group × week interaction, and age as covariates. Robust (sandwich) standard errors were used. Regression coefficients (B), standard errors, Wald chi-squared statistics, 95% confidence intervals, and p-values for group × week comparisons are reported.||||||0.14||||||This is the sixth week of tracking data. A P value \< 0.05 indicated a statistically significant difference.|Generalized Estimating Equations, GEE|Repeated-measures GEE was used to examine the group × time interaction between week 0 and week 6.||Generalized estimating equations (GEE) were chosen over repeated-measures analysis of variance or generalized linear mixed models because they provide estimates of the population mean, are robust to correlated error specifications, can accommodate missing data under the MAR/MCAR assumptions, and do not require sphericity. All tests were two-tailed, with α = 0.05.||||0.140
72577555|NCT00517556|144682291|SUPERIORITY|||||||0.05|||||||Mixed Models Analysis|||||||0.05
72577556|NCT01130597|144682346|SUPERIORITY_OR_OTHER_LEGACY||Percentage of Participants|90.5|||||TWO_SIDED|95.0|80.4|96.4|||||Clopper-Pearson was used to arrive at the 95% Confidence Interval|||96.4|80.4|
72577557|NCT01130597|144682351|SUPERIORITY_OR_OTHER_LEGACY||Percentage of Participants|84.1|||||TWO_SIDED|95.0|72.7|92.1|||||Clopper-Pearson was used to arrive at the 95% Confidence Interval|||92.1|72.7|
72577558|NCT05819203|144682420|SUPERIORITY|||||||0.0013|||||||Wilcoxon (Mann-Whitney)|||Comparison of the means of AUC on global score or ARSSQ during the first 10 days of the study between both groups.||||0.0013
72577559|NCT05819203|144682421|SUPERIORITY|||||||0.0209|||||||Cox survival regression and p Wald|||Comparison of the mean duration of common cold during the study between both groups.||||0.0209
72577560|NCT05819203|144682422|SUPERIORITY|||||||0.0399|||||||Cox survival regression and p Wald|||Comparison of the mean duration of impact of common cold on quality of life during the study between both groups.||||0.0399
72577561|NCT05819203|144682423|SUPERIORITY|||||||0.0015|||||||Poisson regression|||||||0.0015
72577562|NCT05819203|144682424|SUPERIORITY||||||>|0.05||||||not significant|Poisson regression|||||||>0.05
72577563|NCT05819203|144682425|SUPERIORITY|||||||0.0029|||||||Poisson regression|||||||0.0029
72577564|NCT05819203|144682426|SUPERIORITY|||||||0.0006|||||||Poisson regression|||||||0.0006
72577565|NCT05819203|144682427|SUPERIORITY|||||||0.0513|||||||Poisson regression|||||||0.0513
72577566|NCT05819203|144682428|SUPERIORITY|||||||0.0789|||||||Poisson regression|||||||0.0789
72577567|NCT05819203|144682429|SUPERIORITY||||||<|0.0001|||||||Poisson regression|||||||<0.0001
72577568|NCT05819203|144682430|SUPERIORITY|Comparison of the means of AUC on global score or ARSSQ during the first 10 days of the study between both groups.||||||0.0034|||||||t-test, 2 sided|||||||0.0034
72577569|NCT02521376|144682435|OTHER||Geometric Mean Ratio (GMR)|43.69|||||TWO_SIDED|90.0|24.59|77.62||||||||77.62|24.59|
72577570|NCT02521376|144682435|OTHER||GMR|233.63|||||TWO_SIDED|90.0|141.85|384.79||||||||384.79|141.85|
72577571|NCT02521376|144682435|OTHER||GMR|219.2|||||TWO_SIDED|90.0|139.74|343.84||||||||343.84|139.74|
72577572|NCT02521376|144682435|OTHER||GMR|108.5|||||TWO_SIDED|90.0|77.2|152.48||||||||152.48|77.20|
72577573|NCT02521376|144682436|OTHER||GMR|55.71|||||TWO_SIDED|90.0|34.7|89.42||||||||89.42|34.70|
72577574|NCT02521376|144682436|OTHER||GMR|211.94|||||TWO_SIDED|90.0|132.49|339.03||||||||339.03|132.49|
72577575|NCT02521376|144682436|OTHER||GMR|171.33|||||TWO_SIDED|90.0|108.17|271.37||||||||271.37|108.17|
72629100|NCT06946888|144786444|OTHER|A generalized estimating equation (GEE) model included group (intervention group vs. control group), week (categorical: 0-8), group × week interaction, and age as covariates. Robust (sandwich) standard errors were used. Regression coefficients (B), standard errors, Wald chi-squared statistics, 95% confidence intervals, and p-values for group × week comparisons are reported.||||||0.079||||||This is the seventh week of tracking data. A P value \< 0.05 indicated a statistically significant difference.|Generalized Estimating Equations, GEE|Repeated-measures GEE was used to examine the group × time interaction between week 0 and week 7.||Generalized estimating equations (GEE) were chosen over repeated-measures analysis of variance or generalized linear mixed models because they provide estimates of the population mean, are robust to correlated error specifications, can accommodate missing data under the MAR/MCAR assumptions, and do not require sphericity. All tests were two-tailed, with α = 0.05.||||0.079
72629101|NCT06946888|144786444|OTHER|A generalized estimating equation (GEE) model included group (intervention group vs. control group), week (categorical: 0-8), group × week interaction, and age as covariates. Robust (sandwich) standard errors were used. Regression coefficients (B), standard errors, Wald chi-squared statistics, 95% confidence intervals, and p-values for group × week comparisons are reported.||||||0.151||||||This is the eighth week of tracking data. A P value \< 0.05 indicated a statistically significant difference.|Generalized Estimating Equations, GEE|Repeated-measures GEE was used to examine the group × time interaction between week 0 and week 8.||Generalized estimating equations (GEE) were chosen over repeated-measures analysis of variance or generalized linear mixed models because they provide estimates of the population mean, are robust to correlated error specifications, can accommodate missing data under the MAR/MCAR assumptions, and do not require sphericity. All tests were two-tailed, with α = 0.05.||||0.151
72629102|NCT06946888|144786445|OTHER|A generalized estimating equation (GEE) model included group (intervention group vs. control group), week (categorical: 0-8), group × week interaction, and age as covariates. Robust (sandwich) standard errors were used. Regression coefficients (B), standard errors, Wald chi-squared statistics, 95% confidence intervals, and p-values for group × week comparisons are reported.||||||0.63||||||This is the first week of tracking. A P value \< 0.05 indicated a statistically significant difference.|Generalized Estimating Equations, GEE|Repeated-measures GEE was used to examine the group × time interaction between week 0 and week 1.||Generalized estimating equations (GEE) were chosen over repeated-measures analysis of variance or generalized linear mixed models because they provide estimates of the population mean, are robust to correlated error specifications, can accommodate missing data under the MAR/MCAR assumptions, and do not require sphericity. All tests were two-tailed, with α = 0.05.||||0.63
72629103|NCT06946888|144786445|OTHER|A generalized estimating equation (GEE) model included group (intervention group vs. control group), week (categorical: 0-8), group × week interaction, and age as covariates. Robust (sandwich) standard errors were used. Regression coefficients (B), standard errors, Wald chi-squared statistics, 95% confidence intervals, and p-values for group × week comparisons are reported.||||||0.608||||||This is the second week of tracking data. A P value \< 0.05 indicated a statistically significant difference.|Generalized Estimating Equations, GEE|Repeated-measures GEE was used to examine the group × time interaction between week 0 and week 2.||Generalized estimating equations (GEE) were chosen over repeated-measures analysis of variance or generalized linear mixed models because they provide estimates of the population mean, are robust to correlated error specifications, can accommodate missing data under the MAR/MCAR assumptions, and do not require sphericity. All tests were two-tailed, with α = 0.05.||||0.608
72629104|NCT06946888|144786445|OTHER|A generalized estimating equation (GEE) model included group (intervention group vs. control group), week (categorical: 0-8), group × week interaction, and age as covariates. Robust (sandwich) standard errors were used. Regression coefficients (B), standard errors, Wald chi-squared statistics, 95% confidence intervals, and p-values for group × week comparisons are reported.||||||0.244||||||This is the third week of tracking data. A P value \< 0.05 indicated a statistically significant difference.|Generalized Estimating Equations, GEE|Repeated-measures GEE was used to examine the group × time interaction between week 0 and week 3.||Generalized estimating equations (GEE) were chosen over repeated-measures analysis of variance or generalized linear mixed models because they provide estimates of the population mean, are robust to correlated error specifications, can accommodate missing data under the MAR/MCAR assumptions, and do not require sphericity. All tests were two-tailed, with α = 0.05.||||0.244
72629105|NCT06946888|144786445|OTHER|A generalized estimating equation (GEE) model included group (intervention group vs. control group), week (categorical: 0-8), group × week interaction, and age as covariates. Robust (sandwich) standard errors were used. Regression coefficients (B), standard errors, Wald chi-squared statistics, 95% confidence intervals, and p-values for group × week comparisons are reported.||||||0.052||||||This is the fourth week of tracking data. A P value \< 0.05 indicated a statistically significant difference.|Generalized Estimating Equations, GEE|Repeated-measures GEE was used to examine the group × time interaction between week 0 and week 4.||Generalized estimating equations (GEE) were chosen over repeated-measures analysis of variance or generalized linear mixed models because they provide estimates of the population mean, are robust to correlated error specifications, can accommodate missing data under the MAR/MCAR assumptions, and do not require sphericity. All tests were two-tailed, with α = 0.05.||||0.052
72629106|NCT06946888|144786445|OTHER|A generalized estimating equation (GEE) model included group (intervention group vs. control group), week (categorical: 0-8), group × week interaction, and age as covariates. Robust (sandwich) standard errors were used. Regression coefficients (B), standard errors, Wald chi-squared statistics, 95% confidence intervals, and p-values for group × week comparisons are reported.||||||0.229||||||This is the fifth week of tracking data. A P value \< 0.05 indicated a statistically significant difference.|Generalized Estimating Equations, GEE|Repeated-measures GEE was used to examine the group × time interaction between week 0 and week 5.||Generalized estimating equations (GEE) were chosen over repeated-measures analysis of variance or generalized linear mixed models because they provide estimates of the population mean, are robust to correlated error specifications, can accommodate missing data under the MAR/MCAR assumptions, and do not require sphericity. All tests were two-tailed, with α = 0.05.||||0.229
72629107|NCT06946888|144786445|OTHER|A generalized estimating equation (GEE) model included group (intervention group vs. control group), week (categorical: 0-8), group × week interaction, and age as covariates. Robust (sandwich) standard errors were used. Regression coefficients (B), standard errors, Wald chi-squared statistics, 95% confidence intervals, and p-values for group × week comparisons are reported.||||||0.184||||||This is the sixth week of tracking data. A P value \< 0.05 indicated a statistically significant difference.|Generalized Estimating Equations, GEE|Repeated-measures GEE was used to examine the group × time interaction between week 0 and week 6.||Generalized estimating equations (GEE) were chosen over repeated-measures analysis of variance or generalized linear mixed models because they provide estimates of the population mean, are robust to correlated error specifications, can accommodate missing data under the MAR/MCAR assumptions, and do not require sphericity. All tests were two-tailed, with α = 0.05.||||0.184
72629108|NCT06946888|144786445|OTHER|A generalized estimating equation (GEE) model included group (intervention group vs. control group), week (categorical: 0-8), group × week interaction, and age as covariates. Robust (sandwich) standard errors were used. Regression coefficients (B), standard errors, Wald chi-squared statistics, 95% confidence intervals, and p-values for group × week comparisons are reported.||||||0.148||||||This is the seventh week of tracking data. A P value \< 0.05 indicated a statistically significant difference.|Generalized Estimating Equations, GEE|Repeated-measures GEE was used to examine the group × time interaction between week 0 and week 7.||Generalized estimating equations (GEE) were chosen over repeated-measures analysis of variance or generalized linear mixed models because they provide estimates of the population mean, are robust to correlated error specifications, can accommodate missing data under the MAR/MCAR assumptions, and do not require sphericity. All tests were two-tailed, with α = 0.05.||||0.148
72629109|NCT06946888|144786445|OTHER|A generalized estimating equation (GEE) model included group (intervention group vs. control group), week (categorical: 0-8), group × week interaction, and age as covariates. Robust (sandwich) standard errors were used. Regression coefficients (B), standard errors, Wald chi-squared statistics, 95% confidence intervals, and p-values for group × week comparisons are reported.||||||0.143||||||This is the eighth week of tracking data. A P value \< 0.05 indicated a statistically significant difference.|Generalized Estimating Equations, GEE|Repeated-measures GEE was used to examine the group × time interaction between week 0 and week 8.||Generalized estimating equations (GEE) were chosen over repeated-measures analysis of variance or generalized linear mixed models because they provide estimates of the population mean, are robust to correlated error specifications, can accommodate missing data under the MAR/MCAR assumptions, and do not require sphericity. All tests were two-tailed, with α = 0.05.||||0.143
72629110|NCT06946888|144786446|OTHER|A generalized estimating equation (GEE) model included group (intervention group vs. control group), week (categorical: 0-8), group × week interaction, and age as covariates. Robust (sandwich) standard errors were used. Regression coefficients (B), standard errors, Wald chi-squared statistics, 95% confidence intervals, and p-values for group × week comparisons are reported.||||||0.333||||||This is the first week of tracking. A P value \< 0.05 indicated a statistically significant difference.|Generalized Estimating Equations, GEE|Repeated-measures GEE was used to examine the group × time interaction between week 0 and week 1.||Generalized estimating equations (GEE) were chosen over repeated-measures analysis of variance or generalized linear mixed models because they provide estimates of the population mean, are robust to correlated error specifications, can accommodate missing data under the MAR/MCAR assumptions, and do not require sphericity. All tests were two-tailed, with α = 0.05.||||0.333
72577576|NCT02521376|144682436|OTHER||GMR|107.35|||||TWO_SIDED|90.0|72.71|158.51||||||||158.51|72.71|
72577577|NCT03597464|144682442|OTHER|"The model is based on a logistic regression with terms for treatment, baseline UPCR, biopsy class, MMF use at baseline and region.~Subjects who withdrew from the study prior to the visit assessments and thus provide insufficient visit data were defined as non-responders."|Odds Ratio (OR)|2.3||||0.004|TWO_SIDED|95.0|1.3|4.05|||Regression, Logistic|||Month 12 (AURORA 2 baseline)||4.05|1.30|0.004
72577578|NCT03597464|144682442|OTHER|"The model is based on a logistic regression with terms for treatment, baseline UPCR, biopsy class, MMF use at baseline and region.~Subjects who withdrew from the study prior to the visit assessments and thus provide insufficient visit data were defined as non-responders."|Odds Ratio (OR)|2.19||||0.006|TWO_SIDED|95.0|1.25|3.83|||Regression, Logistic|||Month 18||3.83|1.25|0.006
72577579|NCT03597464|144682442|OTHER|"The model is based on a logistic regression with terms for treatment, baseline UPCR, biopsy class, MMF use at baseline and region.~Subjects who withdrew from the study prior to the visit assessments and thus provide insufficient visit data were defined as non-responders."|Odds Ratio (OR)|1.81||||0.035|TWO_SIDED|95.0|1.04|3.16|||Regression, Logistic|||Month 24||3.16|1.04|0.035
72577580|NCT03597464|144682442|OTHER|"The model is based on a logistic regression with terms for treatment, baseline UPCR, biopsy class, MMF use at baseline and region.~Subjects who withdrew from the study prior to the visit assessments and thus provide insufficient visit data were defined as non-responders."|Odds Ratio (OR)|2.24||||0.005|TWO_SIDED|95.0|1.28|3.92|||Regression, Logistic|||Month 30||3.92|1.28|0.005
72577581|NCT03597464|144682442|OTHER|"The model is based on a logistic regression with terms for treatment, baseline UPCR, biopsy class, MMF use at baseline and region.~Subjects who withdrew from the study prior to the visit assessments and thus provide insufficient visit data were defined as non-responders."|Odds Ratio (OR)|1.74||||0.051|TWO_SIDED|95.0|1.0|3.03|||Regression, Logistic|||Month 36||3.03|1.00|0.051
72577582|NCT03597464|144682443|OTHER|"The model is based on a logistic regression with terms for treatment, baseline UPCR, biopsy class, MMF use at baseline and region.~Subjects who withdrew from the study prior to the visit assessments and thus provide insufficient visit data were defined as non-responders."|Odds Ratio (OR)|3.99|||<|0.001|TWO_SIDED|95.0|1.88|8.46|||Regression, Logistic|||Month 12 (AURORA 2 baseline)||8.46|1.88|<0.001
72577583|NCT03597464|144682443|OTHER|"The model is based on a logistic regression with terms for treatment, baseline UPCR, biopsy class, MMF use at baseline and region.~Subjects who withdrew from the study prior to the visit assessments and thus provide insufficient visit data were defined as non-responders."|Odds Ratio (OR)|2.5||||0.008|TWO_SIDED|95.0|1.28|4.88|||Regression, Logistic|||Month 18||4.88|1.28|0.008
72410752|NCT02039505|144329987|SUPERIORITY||Adjusted Odds Ratio|3.48||||0.0067|TWO_SIDED|95.0|1.407|8.626|||Cochran-Mantel-Haenszel||CMH test was used for analysis. Prior TNFα antagonist use (yes/no) was used as stratification factor.|||8.626|1.407|0.0067
72577584|NCT03597464|144682443|OTHER|"The model is based on a logistic regression with terms for treatment, baseline UPCR, biopsy class, MMF use at baseline and region.~Subjects who withdrew from the study prior to the visit assessments and thus provide insufficient visit data were defined as non-responders."|Odds Ratio (OR)|2.68||||0.001|TWO_SIDED|95.0|1.46|4.91|||Regression, Logistic|||Month 24||4.91|1.46|0.001
72410753|NCT02039505|144329988|SUPERIORITY||Adjusted Odds Ratio|3.49||||0.0066|TWO_SIDED|95.0|1.409|8.642|||Cochran-Mantel-Haenszel||CMH test was used for analysis. Prior TNFα antagonist use (yes/no) was used as stratification factor.|||8.642|1.409|0.0066
72577585|NCT03597464|144682443|OTHER|"The model is based on a logistic regression with terms for treatment, baseline UPCR, biopsy class, MMF use at baseline and region.~Subjects who withdrew from the study prior to the visit assessments and thus provide insufficient visit data were defined as non-responders."|Odds Ratio (OR)|1.86||||0.04|TWO_SIDED|95.0|1.03|3.34|||Regression, Logistic|||Month 30||3.34|1.03|0.040
72577586|NCT03597464|144682443|OTHER|"The model is based on a logistic regression with terms for treatment, baseline UPCR, biopsy class, MMF use at baseline and region.~Subjects who withdrew from the study prior to the visit assessments and thus provide insufficient visit data were defined as non-responders."|Odds Ratio (OR)|1.39||||0.29|TWO_SIDED|95.0|0.75|2.58|||Regression, Logistic|||Month 36||2.58|0.75|0.290
72577587|NCT03597464|144682444|OTHER||Odds Ratio (OR)|0.56||||0.045|TWO_SIDED|95.0|0.32|0.99|||Regression, Logistic|||Number of subjects with adequate renal response. This model is based on a logistic regression with terms for treatment, baseline urine protein creatinine ratio (UPCR), biopsy class, mycophenolate mofetil (MMF) use at baseline and region. An odds ratio \< unity indicates benefit for voclosporin.||0.99|0.32|0.045
72577588|NCT03597464|144682445|SUPERIORITY||Least Squares Mean difference|-0.8||||0.238|TWO_SIDED|95.0|-2.1|0.5|||Mixed Models Analysis|||Month 18||0.5|-2.1|0.238
72577589|NCT03597464|144682445|SUPERIORITY||Least Squares Mean difference|-0.7||||0.215|TWO_SIDED|95.0|-1.8|0.4|||Mixed Models Analysis|||Month 24||0.4|-1.8|0.215
72577590|NCT03597464|144682445|SUPERIORITY||Least Squares Mean difference|-0.7||||0.246|TWO_SIDED|95.0|-1.8|0.5|||Mixed Models Analysis|||Month 36||0.5|-1.8|0.246
72577591|NCT03597464|144682446|SUPERIORITY||Least Squares Mean difference|-0.65||||0.001|TWO_SIDED|95.0|-1.05|-0.26|||Mixed Models Analysis|||Month 12 (AURORA 2 baseline)||-0.26|-1.05|0.001
72577592|NCT03597464|144682446|SUPERIORITY||Least Squares Mean difference|-0.63||||0.029|TWO_SIDED|95.0|-1.2|-0.07|||Mixed Models Analysis|||Month 18||-0.07|-1.20|0.029
72577593|NCT03597464|144682446|SUPERIORITY||Least Squares Mean difference|-0.77||||0.002|TWO_SIDED|95.0|-1.24|-0.29|||Mixed Models Analysis|||Month 24||-0.29|-1.24|0.002
72577594|NCT03597464|144682446|SUPERIORITY||Least Squares Mean difference|-0.91||||0.002|TWO_SIDED|95.0|-1.49|-0.33|||Mixed Models Analysis|||Month 30||-0.33|-1.49|0.002
72577595|NCT03597464|144682446|SUPERIORITY||Least Squares Mean difference|-0.48||||0.106|TWO_SIDED|95.0|-1.06|-0.1|||Mixed Models Analysis|||Month 36||-0.10|-1.06|0.106
72577596|NCT03597464|144682447|SUPERIORITY||Least Squares Mean difference|-2.7||||0.041|TWO_SIDED|95.0|-5.3|-0.1|||Mixed Models Analysis|||Month 12 (AURORA 2 baseline)||-0.1|-5.3|0.041
72577597|NCT03597464|144682447|SUPERIORITY||Least Squares Mean difference|-1.8||||0.292|TWO_SIDED|95.0|-5.1|1.6|||Mixed Models Analysis|||Month 18||1.6|-5.1|0.292
72577598|NCT03597464|144682447|SUPERIORITY||Least Squares Mean difference|-2.2||||0.282|TWO_SIDED|95.0|-6.1|1.8|||Mixed Models Analysis|||Month 24||1.8|-6.1|0.282
72577599|NCT03597464|144682447|SUPERIORITY||Least Squares Mean difference|0.9||||0.659|TWO_SIDED|95.0|-3.2|5.1|||Mixed Models Analysis|||Month 30||5.1|-3.2|0.659
72577600|NCT03597464|144682447|SUPERIORITY||Least Squares Mean difference|1.8||||0.438|TWO_SIDED|95.0|-2.8|6.4|||Mixed Models Analysis|||Month 36||6.4|-2.8|0.438
72577601|NCT03597464|144682448|SUPERIORITY||Least Squares Mean difference|-67.7||||0.002|TWO_SIDED|95.0|-110.4|-25.1|||Mixed Models Analysis|||Month 12 (AURORA 2 baseline)||-25.1|-110.4|0.002
72577602|NCT03597464|144682448|SUPERIORITY||Least Squares Mean difference|-87.7||||0.007|TWO_SIDED|95.0|-151.2|-24.2|||Mixed Models Analysis|||Month 18||-24.2|-151.2|0.007
72577603|NCT03597464|144682448|SUPERIORITY||Least Squares Mean difference|-47.0||||0.035|TWO_SIDED|95.0|-90.8|-3.3|||Mixed Models Analysis|||Month 24||-3.3|-90.8|0.035
72577604|NCT03597464|144682448|SUPERIORITY||Least Squares Mean difference|-73.1||||0.005|TWO_SIDED|95.0|-123.5|-22.6|||Mixed Models Analysis|||Month 30||-22.6|-123.5|0.005
72577605|NCT03597464|144682448|SUPERIORITY||Least Squares Mean difference|-19.0||||0.537|TWO_SIDED|95.0|-79.7|41.7|||Mixed Models Analysis|||Month 36||41.7|-79.7|0.537
72577606|NCT03597464|144682449|SUPERIORITY||Least Squares Mean difference|0.084|||<|0.001|TWO_SIDED|95.0|0.035|0.134|||Mixed Models Analysis|||Month 12 (AURORA 2 baseline)||0.134|0.035|<0.001
72577607|NCT03597464|144682449|SUPERIORITY||Least Squares Mean difference|0.051||||0.209|TWO_SIDED|95.0|-0.029|0.131|||Mixed Models Analysis|||Month 18||0.131|-0.029|0.209
72577608|NCT03597464|144682449|SUPERIORITY||Least Squares Mean difference|0.057||||0.353|TWO_SIDED|95.0|-0.064|0.178|||Mixed Models Analysis|||Month 24||0.178|-0.064|0.353
72577609|NCT03597464|144682449|SUPERIORITY||Least Squares Mean difference|-0.036||||0.616|TWO_SIDED|95.0|-0.176|0.105|||Mixed Models Analysis|||Month 30||0.105|-0.176|0.616
72577610|NCT03597464|144682449|SUPERIORITY||Least Squares Mean difference|-0.077||||0.372|TWO_SIDED|95.0|-0.248|0.094|||Mixed Models Analysis|||Month 36||0.094|-0.248|0.372
72577611|NCT02682927|144682473|SUPERIORITY||Percentage difference from Placebo|62.29|||||TWO_SIDED|95.0|47.72|72.8|||||Estimate was obtained from the LSMeans on the log scale as follows: 100 x \[1 - exp(LS mean active - LS mean placebo).|||72.80|47.72|
72542978|NCT03341273|144616158|SUPERIORITY|DOOR is a composite endpoint created using clinical outcomes from Day 1 through Day 5 Visit. It is based on adequate clinical improvement at Day 5 Visit and solicited events from Day 1 through Day 5 Visit.|Pr(Higher DOOR in Placebo at Day 5 Visit|0.63|||<|0.001|TWO_SIDED|95.0|0.57|0.68||Missing DOOR values at Day 5 Visit were first imputed using linear regression using baseline covariates and available DOOR components as covariates.|Wilcoxon (Mann-Whitney)|The Mann-Whitney test was run on the multiple imputed datasets to generate estimates of DOOR probability and p-value||Null: The sum of the probability that a participant assigned to placebo will have a higher DOOR at Day 5 visit than if assigned to the Azithromycin plus one-half the probability of equal DOORs at Day 5 Visit is 50% (i.e., no difference in DOOR at Day 5 Visit).||0.68|0.57|<0.001
72542979|NCT01717456|144616182|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.0|STANDARD_DEVIATION|6.72||0.05|TWO_SIDED|95.0||||No adjustment for multiple comparisons.|t-test, 2 sided|||||||.05
72542980|NCT03751020|144616220|SUPERIORITY||Mean Difference (Net)|-6.34|||<|0.01|TWO_SIDED|95.0|-11.03|-1.64|||Mixed Models Analysis|||The primary comparison was between EW and control to test the interaction between treatment and time.||-1.64|-11.03|<0.01
72542981|NCT03751020|144616221|SUPERIORITY||Mean Difference (Net)|-0.33||||0.03|TWO_SIDED|95.0|-0.62|-0.03|||Mixed Models Analysis|||The primary comparison was between EW and control to test the interaction between treatment and time.||-0.03|-0.62|0.03
72542982|NCT03751020|144616222|SUPERIORITY||Mean Difference (Net)|-4.03||||0.07|TWO_SIDED|95.0|-8.55|0.47|||Mixed Models Analysis|||The primary comparison was between EW and control to test the interaction between treatment and time.||0.47|-8.55|0.07
72542983|NCT03751020|144616223|SUPERIORITY||Mean Difference (Net)|1.12||||0.73|TWO_SIDED|95.0|-6.48|8.77|||Mixed Models Analysis|||The primary comparison was between EW and control to test the interaction between treatment and time.||8.77|-6.48|0.73
72542984|NCT03751020|144616224|SUPERIORITY||Mean Difference (Net)|-1.28||||0.1|TWO_SIDED|95.0|-2.8|0.24|||Mixed Models Analysis|||The primary comparison was between EW and control to test the interaction between treatment and time.||0.24|-2.80|0.10
72542985|NCT03751020|144616225|SUPERIORITY||Mean Difference (Net)|0.09||||0.76|TWO_SIDED|95.0|-1.19|1.57|||Mixed Models Analysis|||The primary comparison was between EW and control to test the interaction between treatment and time.||1.57|-1.19|0.76
72542986|NCT00033631|144616250|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.0||||0.98|TWO_SIDED|95.0|0.83|1.2||Two-sided test, significance level = 0.05|Log Rank||Reference level = 70.2 Gy arm|The original target sample size was 1520 patients with a requirement of 715 deaths to test the hypothesis of overall survival (OS) efficacy of the 79.2 Gy arm. The trial was designed to detect a hazard ratio (HR) of 1.30 (standard/high-dose) with 90% statistical power at a one-sided significance level of 0.025.||1.2|0.83|0.98
72542987|NCT00033631|144616251|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.59|||<|0.0001|TWO_SIDED|95.0|0.5|0.7||Two-sided significance level = 0.05|Gray's test|Reference arm is 70.2 Gy arm||||0.70|0.50|<0.0001
72542988|NCT00033631|144616252|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.66||||0.14|TWO_SIDED|95.0|0.38|1.15|||Gray's test|Two-sided significance level = 0.05|Reference level is 70.2 Gy arm|||1.15|0.38|0.14
72542989|NCT00033631|144616253|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.41||||0.0001|TWO_SIDED|95.0|0.25|0.66|||Gray's test|Two-sided significance level = 0.05|Reference level = 70.2 Gy arm|||0.66|0.25|0.0001
72542990|NCT00033631|144616254|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.65||||0.051|TWO_SIDED|95.0|0.42|1.01||Two-sided significance level = 0.05|Gray's test||Reference level is the 70.2 Gy level|||1.01|0.42|0.051
72542991|NCT00033631|144616255|SUPERIORITY_OR_OTHER_LEGACY|||||||0.29||||||Two-sided significance level = 0.05|Chi-squared|||||||0.29
72542992|NCT00033631|144616256|SUPERIORITY|||||||0.0513|||||||Chi-squared|Two-sided significance level = 0.05||With an expected percentage of erectile disfunction (ED) at 12 months of 29%, a two-sided significance level of 0.05, and 688 patients per arm provides 90% statistical power to detect a reduction in ED to 19%. This calculation assumes 26% ED at baseline and 80% compliance at 12 months. Only participants with baseline ED are analyzed.||||0.0513
72542993|NCT00033631|144616257|SUPERIORITY|||||||0.59|||||||Chi-squared|Two-sided significance level = 0.05||||||0.59
72542994|NCT00528879|144616261|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.38|STANDARD_ERROR_OF_MEAN|0.1014||0.0002||||||Tested at alpha=0.019, applying the Dunnett adjustment|ANCOVA|||||||0.0002
72542995|NCT00528879|144616261|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.41|STANDARD_ERROR_OF_MEAN|0.1016|<|0.0001||||||Tested at alpha=0.019, applying the Dunnett adjustment|ANCOVA|||||||<0.0001
72542996|NCT00528879|144616261|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.54|STANDARD_ERROR_OF_MEAN|0.1021|<|0.0001||||||Tested at alpha=0.019, applying the Dunnett adjustment|ANCOVA|||||||<0.0001
72542997|NCT00528879|144616262|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.8|STANDARD_ERROR_OF_MEAN|3.774|<|0.0019||||||Statistically significant according to hierarchical testing procedure (p\<0.05).|ANCOVA|||||||<0.0019
72542998|NCT00528879|144616262|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.5|STANDARD_ERROR_OF_MEAN|3.781|<|0.0001||||||Statistically significant according to hierarchical testing procedure (p\<0.05).|ANCOVA|||||||<0.0001
72542999|NCT00528879|144616262|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.5|STANDARD_ERROR_OF_MEAN|3.819|<|0.0001||||||Statistically significant according to hierarchical testing procedure (p\<0.05).|ANCOVA|||||||<0.0001
72543000|NCT00528879|144616263|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.32|STANDARD_ERROR_OF_MEAN|0.3344|<|0.0001||||||Statistically significant according to hierarchical testing procedure (p\<0.05).|ANCOVA|||||||<0.0001
72543001|NCT00528879|144616263|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.16|STANDARD_ERROR_OF_MEAN|0.3344|<|0.0001||||||Statistically significant according to hierarchical testing procedure (p\<0.05).|ANCOVA|||||||<0.0001
72629111|NCT06946888|144786446|OTHER|A generalized estimating equation (GEE) model included group (intervention group vs. control group), week (categorical: 0-8), group × week interaction, and age as covariates. Robust (sandwich) standard errors were used. Regression coefficients (B), standard errors, Wald chi-squared statistics, 95% confidence intervals, and p-values for group × week comparisons are reported.||||||0.273||||||This is the second week of tracking data. A P value \< 0.05 indicated a statistically significant difference.|Generalized Estimating Equations, GEE|Repeated-measures GEE was used to examine the group × time interaction between week 0 and week 2.||Generalized estimating equations (GEE) were chosen over repeated-measures analysis of variance or generalized linear mixed models because they provide estimates of the population mean, are robust to correlated error specifications, can accommodate missing data under the MAR/MCAR assumptions, and do not require sphericity. All tests were two-tailed, with α = 0.05.||||0.273
72629112|NCT06946888|144786446|OTHER|A generalized estimating equation (GEE) model included group (intervention group vs. control group), week (categorical: 0-8), group × week interaction, and age as covariates. Robust (sandwich) standard errors were used. Regression coefficients (B), standard errors, Wald chi-squared statistics, 95% confidence intervals, and p-values for group × week comparisons are reported.||||||0.424||||||This is the third week of tracking data. A P value \< 0.05 indicated a statistically significant difference.|Generalized Estimating Equations, GEE|Repeated-measures GEE was used to examine the group × time interaction between week 0 and week 3.||Generalized estimating equations (GEE) were chosen over repeated-measures analysis of variance or generalized linear mixed models because they provide estimates of the population mean, are robust to correlated error specifications, can accommodate missing data under the MAR/MCAR assumptions, and do not require sphericity. All tests were two-tailed, with α = 0.05.||||0.424
72629113|NCT06946888|144786446|OTHER|A generalized estimating equation (GEE) model included group (intervention group vs. control group), week (categorical: 0-8), group × week interaction, and age as covariates. Robust (sandwich) standard errors were used. Regression coefficients (B), standard errors, Wald chi-squared statistics, 95% confidence intervals, and p-values for group × week comparisons are reported.||||||0.482||||||This is the fourth week of tracking data. A P value \< 0.05 indicated a statistically significant difference.|Generalized Estimating Equations, GEE|Repeated-measures GEE was used to examine the group × time interaction between week 0 and week 4.||Generalized estimating equations (GEE) were chosen over repeated-measures analysis of variance or generalized linear mixed models because they provide estimates of the population mean, are robust to correlated error specifications, can accommodate missing data under the MAR/MCAR assumptions, and do not require sphericity. All tests were two-tailed, with α = 0.05.||||0.482
72629114|NCT06946888|144786446|OTHER|A generalized estimating equation (GEE) model included group (intervention group vs. control group), week (categorical: 0-8), group × week interaction, and age as covariates. Robust (sandwich) standard errors were used. Regression coefficients (B), standard errors, Wald chi-squared statistics, 95% confidence intervals, and p-values for group × week comparisons are reported.||||||0.627||||||This is the fifth week of tracking data. A P value \< 0.05 indicated a statistically significant difference.|Generalized Estimating Equations, GEE|Repeated-measures GEE was used to examine the group × time interaction between week 0 and week 5.||Generalized estimating equations (GEE) were chosen over repeated-measures analysis of variance or generalized linear mixed models because they provide estimates of the population mean, are robust to correlated error specifications, can accommodate missing data under the MAR/MCAR assumptions, and do not require sphericity. All tests were two-tailed, with α = 0.05.||||0.627
72629115|NCT06946888|144786446|OTHER|A generalized estimating equation (GEE) model included group (intervention group vs. control group), week (categorical: 0-8), group × week interaction, and age as covariates. Robust (sandwich) standard errors were used. Regression coefficients (B), standard errors, Wald chi-squared statistics, 95% confidence intervals, and p-values for group × week comparisons are reported.||||||0.806||||||This is the sixth week of tracking data. A P value \< 0.05 indicated a statistically significant difference.|Generalized Estimating Equations, GEE|Repeated-measures GEE was used to examine the group × time interaction between week 0 and week 6.||Generalized estimating equations (GEE) were chosen over repeated-measures analysis of variance or generalized linear mixed models because they provide estimates of the population mean, are robust to correlated error specifications, can accommodate missing data under the MAR/MCAR assumptions, and do not require sphericity. All tests were two-tailed, with α = 0.05.||||0.806
72629116|NCT06946888|144786446|OTHER|A generalized estimating equation (GEE) model included group (intervention group vs. control group), week (categorical: 0-8), group × week interaction, and age as covariates. Robust (sandwich) standard errors were used. Regression coefficients (B), standard errors, Wald chi-squared statistics, 95% confidence intervals, and p-values for group × week comparisons are reported.||||||0.786||||||This is the seventh week of tracking data. A P value \< 0.05 indicated a statistically significant difference.|Generalized Estimating Equations, GEE|Repeated-measures GEE was used to examine the group × time interaction between week 0 and week 7.||Generalized estimating equations (GEE) were chosen over repeated-measures analysis of variance or generalized linear mixed models because they provide estimates of the population mean, are robust to correlated error specifications, can accommodate missing data under the MAR/MCAR assumptions, and do not require sphericity. All tests were two-tailed, with α = 0.05.||||0.786
72543002|NCT00528879|144616263|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.97|STANDARD_ERROR_OF_MEAN|0.3365|<|0.0001||||||Statistically significant according to hierarchical testing procedure (p\<0.05).|ANCOVA|||||||<0.0001
72543003|NCT00528879|144616264|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|7.1||||0.1775||||||Statistically significant according to hierarchical testing procedure (p\<0.05).|Modified logistic regression|||||||0.1775
72543004|NCT00528879|144616264|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.7||||0.0275||||||Statistically significant according to hierarchical testing procedure (p\<0.05).|Modified logistic regression|||||||0.0275
72543005|NCT00528879|144616264|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.7||||0.0062||||||Statistically significant according to hierarchical testing procedure (p\<0.05).|Modified logistic regression|||||||0.0062
72543006|NCT00528879|144616265|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.68|STANDARD_ERROR_OF_MEAN|0.3515||||||||Sequential testing procedures were used, and no test was performed for this comparison due to the fact that the previous comparison was not significant.|ANCOVA|||||||
72629117|NCT06946888|144786446|OTHER|A generalized estimating equation (GEE) model included group (intervention group vs. control group), week (categorical: 0-8), group × week interaction, and age as covariates. Robust (sandwich) standard errors were used. Regression coefficients (B), standard errors, Wald chi-squared statistics, 95% confidence intervals, and p-values for group × week comparisons are reported.||||||0.497||||||This is the eighth week of tracking data. A P value \< 0.05 indicated a statistically significant difference.|Generalized Estimating Equations, GEE|Repeated-measures GEE was used to examine the group × time interaction between week 0 and week 8.||Generalized estimating equations (GEE) were chosen over repeated-measures analysis of variance or generalized linear mixed models because they provide estimates of the population mean, are robust to correlated error specifications, can accommodate missing data under the MAR/MCAR assumptions, and do not require sphericity. All tests were two-tailed, with α = 0.05.||||0.497
72629118|NCT06946888|144786447|OTHER|A generalized estimating equation (GEE) model included group (intervention group vs. control group), week (categorical: 0-8), group × week interaction, and age as covariates. Robust (sandwich) standard errors were used. Regression coefficients (B), standard errors, Wald chi-squared statistics, 95% confidence intervals, and p-values for group × week comparisons are reported.||||||0.857||||||This is the first week of tracking data. A P value \< 0.05 indicated a statistically significant difference.|Generalized Estimating Equations, GEE|Repeated-measures GEE was used to examine the group × time interaction between week 0 and week 1.||Generalized estimating equations (GEE) were chosen over repeated-measures analysis of variance or generalized linear mixed models because they provide estimates of the population mean, are robust to correlated error specifications, can accommodate missing data under the MAR/MCAR assumptions, and do not require sphericity. All tests were two-tailed, with α = 0.05.||||0.857
72629119|NCT06946888|144786447|OTHER|A generalized estimating equation (GEE) model included group (intervention group vs. control group), week (categorical: 0-8), group × week interaction, and age as covariates. Robust (sandwich) standard errors were used. Regression coefficients (B), standard errors, Wald chi-squared statistics, 95% confidence intervals, and p-values for group × week comparisons are reported.||||||0.684||||||This is the second week of tracking data. A P value \< 0.05 indicated a statistically significant difference.|Generalized Estimating Equations, GEE|Repeated-measures GEE was used to examine the group × time interaction between week 0 and week 2.||Generalized estimating equations (GEE) were chosen over repeated-measures analysis of variance or generalized linear mixed models because they provide estimates of the population mean, are robust to correlated error specifications, can accommodate missing data under the MAR/MCAR assumptions, and do not require sphericity. All tests were two-tailed, with α = 0.05.||||0.684
72629120|NCT06946888|144786447|OTHER|A generalized estimating equation (GEE) model included group (intervention group vs. control group), week (categorical: 0-8), group × week interaction, and age as covariates. Robust (sandwich) standard errors were used. Regression coefficients (B), standard errors, Wald chi-squared statistics, 95% confidence intervals, and p-values for group × week comparisons are reported.||||||0.333||||||This is the third week of tracking data. A P value \< 0.05 indicated a statistically significant difference.|Generalized Estimating Equations, GEE|Repeated-measures GEE was used to examine the group × time interaction between week 0 and week 3.||Generalized estimating equations (GEE) were chosen over repeated-measures analysis of variance or generalized linear mixed models because they provide estimates of the population mean, are robust to correlated error specifications, can accommodate missing data under the MAR/MCAR assumptions, and do not require sphericity. All tests were two-tailed, with α = 0.05.||||0.333
72629121|NCT06946888|144786447|OTHER|A generalized estimating equation (GEE) model included group (intervention group vs. control group), week (categorical: 0-8), group × week interaction, and age as covariates. Robust (sandwich) standard errors were used. Regression coefficients (B), standard errors, Wald chi-squared statistics, 95% confidence intervals, and p-values for group × week comparisons are reported.||||||0.09||||||This is the fourth week of tracking data. A P value \< 0.05 indicated a statistically significant difference.|Generalized Estimating Equations, GEE|Repeated-measures GEE was used to examine the group × time interaction between week 0 and week 4.||Generalized estimating equations (GEE) were chosen over repeated-measures analysis of variance or generalized linear mixed models because they provide estimates of the population mean, are robust to correlated error specifications, can accommodate missing data under the MAR/MCAR assumptions, and do not require sphericity. All tests were two-tailed, with α = 0.05.||||0.090
72629122|NCT06946888|144786447|OTHER|A generalized estimating equation (GEE) model included group (intervention group vs. control group), week (categorical: 0-8), group × week interaction, and age as covariates. Robust (sandwich) standard errors were used. Regression coefficients (B), standard errors, Wald chi-squared statistics, 95% confidence intervals, and p-values for group × week comparisons are reported.||||||0.545||||||This is the fifth week of tracking data. A P value \< 0.05 indicated a statistically significant difference.|Generalized Estimating Equations, GEE|Repeated-measures GEE was used to examine the group × time interaction between week 0 and week 5.||Generalized estimating equations (GEE) were chosen over repeated-measures analysis of variance or generalized linear mixed models because they provide estimates of the population mean, are robust to correlated error specifications, can accommodate missing data under the MAR/MCAR assumptions, and do not require sphericity. All tests were two-tailed, with α = 0.05.||||0.545
72329446|NCT03037476|144184382|OTHER|General Linear Model|Slope|-0.01||||0.932|TWO_SIDED|95.0|-0.244|0.223|||Mixed Models Analysis|Poisson Regression||Change in Past 12 Month Nonmedical Prescription Drug Use from Baseline to 6 Month Followup||.223|-.244|.932
72543007|NCT00528879|144616265|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.84|STANDARD_ERROR_OF_MEAN|0.3022||0.0068||||||Statistically significant according to hierarchical testing procedure (p\<0.05).|ANCOVA|||||||0.0068
72543008|NCT00528879|144616265|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.78|STANDARD_ERROR_OF_MEAN|0.3535||0.029||||||Statistically significant according to hierarchical testing procedure (p\<0.05).|ANCOVA|||||||0.0290
72410754|NCT02039505|144329989|SUPERIORITY||Adjusted Odds Ratio|2.02||||0.209|TWO_SIDED|95.0|0.677|6.033|||Cochran-Mantel-Haenszel||CMH test was used for analysis. Prior TNFα antagonist use (yes/no) was used as stratification factor.|||6.033|0.677|0.2090
72410755|NCT02039505|144329990|SUPERIORITY||Adjusted Odds Ratio|3.38||||0.1571|TWO_SIDED|95.0|0.636|17.981|||Cochran-Mantel-Haenszel||CMH test was used for analysis. Prior TNFα antagonist use (yes/no) was used as stratification factor.|||17.981|0.636|0.1571
72410756|NCT00097591|144329997|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.82||||0.002|TWO_SIDED|95.0|0.726|0.927||The primary outcome measure was analyzed first in the UA/NSTEMI population, followed by All ACS subjects, followed by the STEMI population.|Gehan-Wilcoxon|||For UA/NSTEMI population||0.927|0.726|0.002
72410757|NCT00097591|144329997|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.793||||0.019|TWO_SIDED|95.0|0.649|0.968|||Gehan-Wilcoxon|||For STEMI population||0.968|0.649|0.019
72410758|NCT00097591|144329997|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.812|||<|0.001|TWO_SIDED|95.0|0.732|0.902|||Gehan-Wilcoxon|Clinical presentation, UA/NSTEMI versus STEMI, was used as a stratification factor.||For All ACS population||0.902|0.732|<0.001
72410759|NCT00097591|144329998|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.314||||0.002|TWO_SIDED|95.0|1.107|1.559|||Log Rank|Clinical presentation, UA/NSTEMI versus STEMI, was used as a stratification factor.||For non-CABG TIMI Major or Minor Bleeding||1.559|1.107|0.002
72410760|NCT00097591|144329998|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.315||||0.029|TWO_SIDED|95.0|1.028|1.683|||Log Rank|Clinical presentation, UA/NSTEMI versus STEMI, was used as a stratification factor.||For non-CABG TIMI Major Bleeding||1.683|1.028|0.029
72410761|NCT00097591|144329998|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.517||||0.015|TWO_SIDED|95.0|1.083|2.126|||Log Rank|Clinical presentation, UA/NSTEMI versus STEMI, was used as a stratification factor.||For the subset of non-CABG TIMI Major Bleeding - Life-threatening events (LT)||2.126|1.083|0.015
72410762|NCT00097591|144329998|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|4.191||||0.002|TWO_SIDED|95.0|1.158|11.113|||Log Rank|Clinical presentation, UA/NSTEMI versus STEMI, was used as a stratification factor.||For the subset of non-CABG TIMI Major Bleeding - LT - Fatal||11.113|1.1580|0.002
72410763|NCT00097591|144329998|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.119||||0.736|TWO_SIDED|95.0|0.582|2.152|||Log Rank|Clinical presentation, UA/NSTEMI versus STEMI, was used as a stratification factor.||For the subset of non-CABG TIMI Major Bleeding - LT - Symptomatic intracranial hemorrage (ICH)||2.152|0.582|0.736
72410764|NCT00097591|144329998|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.617||||0.016|TWO_SIDED|95.0|1.159|5.908|||Log Rank|Clinical presentation, UA/NSTEMI versus STEMI, was used as a stratification factor.||For the subset of non-CABG TIMI Major Bleeding - LT - Requiring inotropes||5.908|1.159|0.016
72410765|NCT00097591|144329998|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.998||||0.995|TWO_SIDED|95.0|0.528|1.885|||Log Rank|Clinical presentation, UA/NSTEMI versus STEMI, was used as a stratification factor.||For the subset of non-CABG TIMI Major Bleeding - LT - Requiring surgical intervention||1.885|0.528|0.995
72410766|NCT00097591|144329998|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.499||||0.084|TWO_SIDED|95.0|0.945|2.379|||Log Rank|Clinical presentation, UA/NSTEMI versus STEMI, was used as a stratification factor.||For the subset of non-CABG TIMI Major Bleeding - LT - Requiring transfusion (\>=4 units)||2.379|0.945|0.084
72410767|NCT00097591|144329998|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.313||||0.022|TWO_SIDED|95.0|1.04|1.656|||Log Rank|Clinical presentation, UA/NSTEMI versus STEMI, was used as a stratification factor.||For the subset of non-CABG TIMI Minor Bleeding||1.656|1.040|0.022
72410768|NCT00097591|144329999|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.784|||<|0.001|TWO_SIDED|95.0|0.688|0.894|||Log Rank|Clinical presentation, UA/NSTEMI versus STEMI, was used as a stratification factor.||Through 30 days||0.894|0.688|<0.001
72410769|NCT00097591|144329999|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.794|||<|0.001|TWO_SIDED|95.0|0.703|0.896|||Log Rank|Clinical presentation, UA/NSTEMI versus STEMI, was used as a stratification factor.||Through 90 days||0.896|0.703|<0.001
72410770|NCT00097591|144330000|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.767|||<|0.001|TWO_SIDED|95.0|0.672|0.876|||Log Rank|Clinical presentation, UA/NSTEMI versus STEMI, was used as a stratification factor.||Through 30 days||0.876|0.672|<0.001
72410771|NCT00097591|144330000|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.797|||<|0.001|TWO_SIDED|95.0|0.705|0.901|||Log Rank|Clinical presentation, UA/NSTEMI versus STEMI, was used as a stratification factor.||Through 90 days||0.901|0.705|<0.001
72410772|NCT00097591|144330001|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.838|||<|0.001|TWO_SIDED|95.0|0.762|0.921|||Log Rank|Clinical presentation, UA/NSTEMI versus STEMI, was used as a stratification factor.||||0.921|0.762|<0.001
72410773|NCT00097591|144330002|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.831|||<|0.001|TWO_SIDED|95.0|0.751|0.919|||Log Rank|Clinical presentation, UA/NSTEMI versus STEMI, was used as a stratification factor.||||0.919|0.751|<0.001
72410774|NCT01282710|144330010|SUPERIORITY_OR_OTHER|||||||0.04627||95.0|||||Mixed Models Analysis|||"Agreement between SureCALL® and IUPC Contraction Peak Events~Null hypothesis: the mean peak difference between TOCO and IUPC is equal to 0. Alternative hypothesis: the mean peak difference is not equal to 0."||||.04627
72410775|NCT01282710|144330010|SUPERIORITY_OR_OTHER|||||||0.1676||95.0|||||Mixed Models Analysis|||"Agreement between TOCO and IUPC Contraction Peak Events~Null hypothesis: the mean peak difference between TOCO and IUPC is equal to 0. Alternative hypothesis: the mean peak difference is not equal to 0."||||0.1676
72410776|NCT00009737|144330011|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was tested by comparing the upper limit of the 95% confidence interval for the hazard ratio to the non-inferiority margin of 1.25 in a first step, and then of 1.20 in a second step.|Hazard Ratio (HR)|0.87||||0.053|TWO_SIDED|95.0|0.75|1.0||For difference between arms, \< 0.001 for non-inferiority|Wald Chi-Square Test|||||1.00|0.75|0.053
72629123|NCT06946888|144786447|OTHER|A generalized estimating equation (GEE) model included group (intervention group vs. control group), week (categorical: 0-8), group × week interaction, and age as covariates. Robust (sandwich) standard errors were used. Regression coefficients (B), standard errors, Wald chi-squared statistics, 95% confidence intervals, and p-values for group × week comparisons are reported.||||||0.251||||||This is the sixth week of tracking data. A P value \< 0.05 indicated a statistically significant difference.|Generalized Estimating Equations, GEE|Repeated-measures GEE was used to examine the group × time interaction between week 0 and week 6.||Generalized estimating equations (GEE) were chosen over repeated-measures analysis of variance or generalized linear mixed models because they provide estimates of the population mean, are robust to correlated error specifications, can accommodate missing data under the MAR/MCAR assumptions, and do not require sphericity. All tests were two-tailed, with α = 0.05.||||0.251
72629124|NCT06946888|144786447|OTHER|A generalized estimating equation (GEE) model included group (intervention group vs. control group), week (categorical: 0-8), group × week interaction, and age as covariates. Robust (sandwich) standard errors were used. Regression coefficients (B), standard errors, Wald chi-squared statistics, 95% confidence intervals, and p-values for group × week comparisons are reported.||||||0.701||||||This is the seventh week of tracking data. A P value \< 0.05 indicated a statistically significant difference.|Generalized Estimating Equations, GEE|Repeated-measures GEE was used to examine the group × time interaction between week 0 and week 7.||Generalized estimating equations (GEE) were chosen over repeated-measures analysis of variance or generalized linear mixed models because they provide estimates of the population mean, are robust to correlated error specifications, can accommodate missing data under the MAR/MCAR assumptions, and do not require sphericity. All tests were two-tailed, with α = 0.05.||||0.701
72629125|NCT06946888|144786447|OTHER|A generalized estimating equation (GEE) model included group (intervention group vs. control group), week (categorical: 0-8), group × week interaction, and age as covariates. Robust (sandwich) standard errors were used. Regression coefficients (B), standard errors, Wald chi-squared statistics, 95% confidence intervals, and p-values for group × week comparisons are reported.||||||0.08||||||This is the eighth week of tracking data. A P value \< 0.05 indicated a statistically significant difference.|Generalized Estimating Equations, GEE|Repeated-measures GEE was used to examine the group × time interaction between week 0 and week 8.||Generalized estimating equations (GEE) were chosen over repeated-measures analysis of variance or generalized linear mixed models because they provide estimates of the population mean, are robust to correlated error specifications, can accommodate missing data under the MAR/MCAR assumptions, and do not require sphericity. All tests were two-tailed, with α = 0.05.||||0.080
72629126|NCT06946888|144786448|OTHER|A generalized estimating equation (GEE) model included group (intervention group vs. control group), week (categorical: 0-8), group × week interaction, and age as covariates. Robust (sandwich) standard errors were used. Regression coefficients (B), standard errors, Wald chi-squared statistics, 95% confidence intervals, and p-values for group × week comparisons are reported.||||||0.636||||||This is the first week of tracking data. A P value \< 0.05 indicated a statistically significant difference.|Generalized Estimating Equations, GEE|Repeated-measures GEE was used to examine the group × time interaction between week 0 and week 1.||Generalized estimating equations (GEE) were chosen over repeated-measures analysis of variance or generalized linear mixed models because they provide estimates of the population mean, are robust to correlated error specifications, can accommodate missing data under the MAR/MCAR assumptions, and do not require sphericity. All tests were two-tailed, with α = 0.05.||||0.636
72629127|NCT06946888|144786448|OTHER|A generalized estimating equation (GEE) model included group (intervention group vs. control group), week (categorical: 0-8), group × week interaction, and age as covariates. Robust (sandwich) standard errors were used. Regression coefficients (B), standard errors, Wald chi-squared statistics, 95% confidence intervals, and p-values for group × week comparisons are reported.||||||0.909||||||This is the second week of tracking data. A P value \< 0.05 indicated a statistically significant difference.|Generalized Estimating Equations, GEE|Repeated-measures GEE was used to examine the group × time interaction between week 0 and week 2.||Generalized estimating equations (GEE) were chosen over repeated-measures analysis of variance or generalized linear mixed models because they provide estimates of the population mean, are robust to correlated error specifications, can accommodate missing data under the MAR/MCAR assumptions, and do not require sphericity. All tests were two-tailed, with α = 0.05.||||0.909
72629128|NCT06946888|144786448|OTHER|A generalized estimating equation (GEE) model included group (intervention group vs. control group), week (categorical: 0-8), group × week interaction, and age as covariates. Robust (sandwich) standard errors were used. Regression coefficients (B), standard errors, Wald chi-squared statistics, 95% confidence intervals, and p-values for group × week comparisons are reported.||||||0.627||||||This is the third week of tracking data. A P value \< 0.05 indicated a statistically significant difference.|Generalized Estimating Equations, GEE|Repeated-measures GEE was used to examine the group × time interaction between week 0 and week 3.||Generalized estimating equations (GEE) were chosen over repeated-measures analysis of variance or generalized linear mixed models because they provide estimates of the population mean, are robust to correlated error specifications, can accommodate missing data under the MAR/MCAR assumptions, and do not require sphericity. All tests were two-tailed, with α = 0.05.||||0.627
72629129|NCT06946888|144786448|OTHER|A generalized estimating equation (GEE) model included group (intervention group vs. control group), week (categorical: 0-8), group × week interaction, and age as covariates. Robust (sandwich) standard errors were used. Regression coefficients (B), standard errors, Wald chi-squared statistics, 95% confidence intervals, and p-values for group × week comparisons are reported.||||||0.474||||||This is the fourth week of tracking data. A P value \< 0.05 indicated a statistically significant difference.|Generalized Estimating Equations, GEE|Repeated-measures GEE was used to examine the group × time interaction between week 0 and week 4.||Generalized estimating equations (GEE) were chosen over repeated-measures analysis of variance or generalized linear mixed models because they provide estimates of the population mean, are robust to correlated error specifications, can accommodate missing data under the MAR/MCAR assumptions, and do not require sphericity. All tests were two-tailed, with α = 0.05.||||0.474
72629130|NCT06946888|144786448|OTHER|A generalized estimating equation (GEE) model included group (intervention group vs. control group), week (categorical: 0-8), group × week interaction, and age as covariates. Robust (sandwich) standard errors were used. Regression coefficients (B), standard errors, Wald chi-squared statistics, 95% confidence intervals, and p-values for group × week comparisons are reported.||||||0.378||||||This is the fifth week of tracking data. A P value \< 0.05 indicated a statistically significant difference.|Generalized Estimating Equations, GEE|Repeated-measures GEE was used to examine the group × time interaction between week 0 and week 5.||Generalized estimating equations (GEE) were chosen over repeated-measures analysis of variance or generalized linear mixed models because they provide estimates of the population mean, are robust to correlated error specifications, can accommodate missing data under the MAR/MCAR assumptions, and do not require sphericity. All tests were two-tailed, with α = 0.05.||||0.378
72629131|NCT06946888|144786448|OTHER|A generalized estimating equation (GEE) model included group (intervention group vs. control group), week (categorical: 0-8), group × week interaction, and age as covariates. Robust (sandwich) standard errors were used. Regression coefficients (B), standard errors, Wald chi-squared statistics, 95% confidence intervals, and p-values for group × week comparisons are reported.||||||0.768||||||This is the sixth week of tracking data. A P value \< 0.05 indicated a statistically significant difference.|Generalized Estimating Equations, GEE|Repeated-measures GEE was used to examine the group × time interaction between week 0 and week 6.||Generalized estimating equations (GEE) were chosen over repeated-measures analysis of variance or generalized linear mixed models because they provide estimates of the population mean, are robust to correlated error specifications, can accommodate missing data under the MAR/MCAR assumptions, and do not require sphericity. All tests were two-tailed, with α = 0.05.||||0.768
72629132|NCT06946888|144786448|OTHER|A generalized estimating equation (GEE) model included group (intervention group vs. control group), week (categorical: 0-8), group × week interaction, and age as covariates. Robust (sandwich) standard errors were used. Regression coefficients (B), standard errors, Wald chi-squared statistics, 95% confidence intervals, and p-values for group × week comparisons are reported.||||||0.909||||||This is the seventh week of tracking data. A P value \< 0.05 indicated a statistically significant difference.|Generalized Estimating Equations, GEE|Repeated-measures GEE was used to examine the group × time interaction between week 0 and week 7.||Generalized estimating equations (GEE) were chosen over repeated-measures analysis of variance or generalized linear mixed models because they provide estimates of the population mean, are robust to correlated error specifications, can accommodate missing data under the MAR/MCAR assumptions, and do not require sphericity. All tests were two-tailed, with α = 0.05.||||0.909
72629133|NCT06946888|144786448|OTHER|A generalized estimating equation (GEE) model included group (intervention group vs. control group), week (categorical: 0-8), group × week interaction, and age as covariates. Robust (sandwich) standard errors were used. Regression coefficients (B), standard errors, Wald chi-squared statistics, 95% confidence intervals, and p-values for group × week comparisons are reported.||||||0.449||||||This is the eighth week of tracking data. A P value \< 0.05 indicated a statistically significant difference.|Generalized Estimating Equations, GEE|Repeated-measures GEE was used to examine the group × time interaction between week 0 and week 8.||Generalized estimating equations (GEE) were chosen over repeated-measures analysis of variance or generalized linear mixed models because they provide estimates of the population mean, are robust to correlated error specifications, can accommodate missing data under the MAR/MCAR assumptions, and do not require sphericity. All tests were two-tailed, with α = 0.05.||||0.449
72629134|NCT06946888|144786449|OTHER|A generalized estimating equation (GEE) model included group (intervention group vs. control group), week (categorical: 0-8), group × week interaction, and age as covariates. Robust (sandwich) standard errors were used. Regression coefficients (B), standard errors, Wald chi-squared statistics, 95% confidence intervals, and p-values for group × week comparisons are reported.||||||0.593||||||This is the first week of tracking data. A P value \< 0.05 indicated a statistically significant difference.|Generalized Estimating Equations, GEE|Repeated-measures GEE was used to examine the group × time interaction between week 0 and week 1.||Generalized estimating equations (GEE) were chosen over repeated-measures analysis of variance or generalized linear mixed models because they provide estimates of the population mean, are robust to correlated error specifications, can accommodate missing data under the MAR/MCAR assumptions, and do not require sphericity. All tests were two-tailed, with α = 0.05.||||0.593
72629135|NCT06946888|144786449|OTHER|A generalized estimating equation (GEE) model included group (intervention group vs. control group), week (categorical: 0-8), group × week interaction, and age as covariates. Robust (sandwich) standard errors were used. Regression coefficients (B), standard errors, Wald chi-squared statistics, 95% confidence intervals, and p-values for group × week comparisons are reported.||||||0.994||||||This is the second week of tracking data. A P value \< 0.05 indicated a statistically significant difference.|Generalized Estimating Equations, GEE|Repeated-measures GEE was used to examine the group × time interaction between week 0 and week 2.||Generalized estimating equations (GEE) were chosen over repeated-measures analysis of variance or generalized linear mixed models because they provide estimates of the population mean, are robust to correlated error specifications, can accommodate missing data under the MAR/MCAR assumptions, and do not require sphericity. All tests were two-tailed, with α = 0.05.||||0.994
72629136|NCT06946888|144786449|OTHER|A generalized estimating equation (GEE) model included group (intervention group vs. control group), week (categorical: 0-8), group × week interaction, and age as covariates. Robust (sandwich) standard errors were used. Regression coefficients (B), standard errors, Wald chi-squared statistics, 95% confidence intervals, and p-values for group × week comparisons are reported.||||||0.959||||||This is the third week of tracking data. A P value \< 0.05 indicated a statistically significant difference.|Generalized Estimating Equations, GEE|Repeated-measures GEE was used to examine the group × time interaction between week 0 and week 3.||Generalized estimating equations (GEE) were chosen over repeated-measures analysis of variance or generalized linear mixed models because they provide estimates of the population mean, are robust to correlated error specifications, can accommodate missing data under the MAR/MCAR assumptions, and do not require sphericity. All tests were two-tailed, with α = 0.05.||||0.959
72410777|NCT00009737|144330012|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was tested by comparing the upper limit of the 95% confidence interval for the hazard ratio to the non-inferiority margin of 1.25|Hazard Ratio (HR)|0.86||||0.041|TWO_SIDED|95.0|0.74|0.99||For difference between arms, \< 0.001 for non-inferiority|Wald Chi-Square Test|||||0.99|0.74|0.041
72629137|NCT06946888|144786449|OTHER|A generalized estimating equation (GEE) model included group (intervention group vs. control group), week (categorical: 0-8), group × week interaction, and age as covariates. Robust (sandwich) standard errors were used. Regression coefficients (B), standard errors, Wald chi-squared statistics, 95% confidence intervals, and p-values for group × week comparisons are reported.||||||0.946||||||This is the fourth week of tracking data. A P value \< 0.05 indicated a statistically significant difference.|Generalized Estimating Equations, GEE|Repeated-measures GEE was used to examine the group × time interaction between week 0 and week 4.||Generalized estimating equations (GEE) were chosen over repeated-measures analysis of variance or generalized linear mixed models because they provide estimates of the population mean, are robust to correlated error specifications, can accommodate missing data under the MAR/MCAR assumptions, and do not require sphericity. All tests were two-tailed, with α = 0.05.||||0.946
72577612|NCT02682927|144682473|SUPERIORITY||Percentage difference from Placebo|64.75|||||TWO_SIDED|95.0|51.85|74.19|||||Estimate was obtained from the LSMeans on the log scale as follows: 100 x \[1 - exp(LS mean active - LS mean placebo).|||74.19|51.85|
72577613|NCT02682927|144682474|SUPERIORITY||Percentage difference from Placebo|32.43|||||TWO_SIDED|95.0|6.19|51.33|||||Estimate was obtained from the LSMeans on the log scale as follows: 100 x \[1 - exp(LS mean active - LS mean placebo).|||51.33|6.19|
72577614|NCT02682927|144682474|SUPERIORITY||Percentage difference from Placebo|49.88|||||TWO_SIDED|95.0|31.31|63.43|||||Estimate was obtained from the LSMeans on the log scale as follows: 100 x \[1 - exp(LS mean active - LS mean placebo).|||63.43|31.31|
72577615|NCT02682927|144682476|SUPERIORITY||Odds Ratio (OR)|4.773||||0.009|TWO_SIDED|95.0|1.475|15.45|||Regression, Logistic|||||15.450|1.475|0.009
72577616|NCT02682927|144682476|SUPERIORITY||Odds Ratio (OR)|14.96|||<|0.001|TWO_SIDED|95.0|4.484|49.915|||Regression, Logistic|||||49.915|4.484|<0.001
72577617|NCT02682927|144682476|SUPERIORITY||Odds Ratio (OR)|13.4||||0.0001|TWO_SIDED|95.0|3.6|49.8|||Regression, Logistic|||||49.8|3.6|0.0001
72577618|NCT02682927|144682476|SUPERIORITY||Odds Ratio (OR)|53.3|||<|0.0001|TWO_SIDED|95.0|12.9|220.5|||Regression, Logistic|||||220.5|12.9|<0.0001
72577619|NCT02682927|144682479|SUPERIORITY|||||||0.035|||||||Wilcoxon rank sum test|||||||0.035
72577620|NCT02682927|144682479|SUPERIORITY||||||<|0.001|||||||Wilcoxon rank sum test|||||||<0.001
72329447|NCT03037476|144184382|OTHER|General Linear Model|Slope|-0.057||||0.648|TWO_SIDED|95.0|-0.3|0.187|||Mixed Models Analysis|Poisson Regression||Change in Past 12 Month Nonmedical Prescription Drug Use from Baseline to 12 Month Followup||0.187|-.300|.648
72577621|NCT02682927|144682479|SUPERIORITY||Comparing active with placebo|||||0.0002|||||||Wilcoxon rank sum test|||||||0.0002
72577622|NCT02682927|144682479|SUPERIORITY||||||<|0.0001|||||||Wilcoxon rank sum test|||||||<0.0001
72577623|NCT00676780|144682498|SUPERIORITY_OR_OTHER||||||=|0.027||95.0|||||Wilcoxon (Mann-Whitney)|||||||=0.027
72577624|NCT00676780|144682499|SUPERIORITY_OR_OTHER|||||||0.023||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.023
72577625|NCT00676780|144682500|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon (Mann-Whitney)|||Null hypothesis is no change, i.e. median change = 0.0||||<0.001
72577626|NCT02126826|144682525|SUPERIORITY_OR_OTHER||Slope|0.7865|||||TWO_SIDED|90.0|0.6193|0.9537|||ANCOVA|||Investigation of dose proportionality - dose groups 50mg to 300mg||0.9537|0.6193|
72577627|NCT02126826|144682525|SUPERIORITY_OR_OTHER||Slope|1.0171|||||TWO_SIDED|90.0|0.8378|1.1964|||ANCOVA|||Investigation of dose proportionality - dose groups 50mg to 200mg||1.1964|0.8378|
72577628|NCT02126826|144682527|SUPERIORITY_OR_OTHER||Slope|0.9511|||||TWO_SIDED|90.0|0.7654|1.1367|||ANCOVA|||Investigation of dose proportionality - dose groups 50mg to 300mg||1.1367|0.7654|
72577629|NCT02126826|144682527|SUPERIORITY_OR_OTHER||Slope|1.0834|||||TWO_SIDED|90.0|0.8655|1.3013|||ANCOVA|||Investigation of dose proportionality - dose groups 50mg to 200mg||1.3013|0.8655|
72577630|NCT02126826|144682529|SUPERIORITY_OR_OTHER||Slope|0.7832|||||TWO_SIDED|90.0|0.6235|0.9428|||ANCOVA|||Investigation of dose proportionality - dose groups 50mg to 300mg||0.9428|0.6235|
72577631|NCT02126826|144682529|SUPERIORITY_OR_OTHER||Slope|1.0365|||||TWO_SIDED|90.0|0.8593|1.2137|||ANCOVA|||Investigation of dose proportionality - dose groups 50mg to 200mg||1.2137|0.8593|
72577632|NCT02126826|144682531|SUPERIORITY_OR_OTHER||Slope|0.9433|||||TWO_SIDED|90.0|0.7744|1.1122|||ANCOVA|||Investigation of dose proportionality - dose groups 50mg to 300mg||1.1122|0.7744|
72577633|NCT02126826|144682531|SUPERIORITY_OR_OTHER||Slope|1.081|||||TWO_SIDED|90.0|0.8583|1.3037|||ANCOVA|||Investigation of dose proportionality - dose groups 50mg to 200mg||1.3037|0.8583|
72577634|NCT03888066|144682532|SUPERIORITY||Mean Difference (Final Values)|-0.097|STANDARD_ERROR_OF_MEAN|0.015|<|0.001|TWO_SIDED|95.0|-0.128|-0.067|||Mixed model for repeated measures (MMRM)|||Difference in adjusted mean changes (SE)||-0.067|-0.128|< 0.001
72577635|NCT03888066|144682533|SUPERIORITY||Hazard Ratio (HR)|0.63|||=|0.006|TWO_SIDED|95.0|0.45|0.87||Threshold for statistical significance = 0.05|Regression, Cox|||"Hazard Ratio patiromer vs placebo.~The HR for the time to first hyperkalemia event for patiromer vs placebo was calculated. HR and p-value come from a Cox proportional regression model adjusted for geographic region, sex, Baseline T2DM status, Baseline K+ value, and Baseline eGFR.~HR = Hazard Ratio; T2DM=Type 2 diabetes mellitus; eGFR=Estimated glomerular filtration rate"||0.87|0.45|= 0.006
72577636|NCT03888066|144682534|SUPERIORITY||Hazard Ratio (HR)|0.62|||=|0.006|TWO_SIDED|95.0|0.45|0.87||Threshold for statistical significance = 0.05|Regression, Cox|||"Hazard Ratio patiromer vs placebo.~The HR for the time to first hyperkalemia event for patiromer vs placebo was calculated. HR and p-value come from a Cox proportional regression model adjusted for geographic region, sex, Baseline T2DM status, Baseline K+ value, and Baseline eGFR.~HR = Hazard Ratio; T2DM=Type 2 diabetes mellitus; eGFR=Estimated glomerular filtration rate"||0.87|0.45|= 0.006
72577637|NCT03888066|144682535|SUPERIORITY||Annualized event rate ratio|0.658|||<|0.001|TWO_SIDED|95.0|0.534|0.81|||Negative binomial model adjusted for cov|||"NBMAC Annualized event RR patiromer vs placebo.~NBMAC adjusted for geographical region, sex, Baseline T2DM status, Baseline K+ value, and Baseline eGFR. Rate ratio less than 1 favors patiromer.~NBMAC=Negative binomial model adjusted for covariates; RR=Rate Ratio; T2DM=Type 2 diabetes mellitus; eGFR=Estimated glomerular filtration rate"||0.81|0.534|< 0.001
72577638|NCT03888066|144682536|SUPERIORITY||Win Ratio|1.526|||<|0.001|TWO_SIDED|95.0|1.231|1.906|||Win Ratio|||"Win ratio for composite.~Win ratio approach: Patients in the new treatment and control groups are formed into matched pairs based on their risk profiles. For each matched pair, the new treatment patient is labelled winner/loser depending on CV/hyperkalemia event first. The win ratio is the total number of winners divided by the total numbers of losers."||1.906|1.231|<0.001
72577639|NCT03888066|144682536|SUPERIORITY||Win Ratio|0.914|||=|0.744|TWO_SIDED|95.0|0.526|1.578|||Win Ratio|||"Win ratio CV death and hospitalization.~Win ratio approach: Patients in the new treatment and control groups are formed into matched pairs based on their risk profiles. For each matched pair, the new treatment patient is labelled winner/loser depending on CV/hyperkalemia event first. The win ratio is the total number of winners divided by the total numbers of losers. Unmatched win ratio is presented for this endpoint. Win ratio above 1 favors patiromer."||1.578|0.526|= 0.744
72410778|NCT00009737|144330013|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was tested by comparing the upper limit of the 95% confidence interval for the hazard ratio to the non-inferiority margin of 1.25|Hazard Ratio (HR)|0.84||||0.071|TWO_SIDED|95.0|0.69|1.01||For difference between arms, \< 0.001 for non-inferiority|Wald Chi-Square Test|||||1.01|0.69|0.071
72410779|NCT01807585|144330017|NON_INFERIORITY|Non-inferiority was determined by the application of a Z-test with a 10% non-inferiority margin as well as examination of confidence intervals.|Risk Difference (RD)|3.5|||<|0.0001|TWO_SIDED|95.0|-0.7|7.6|||One tailed Z-test|||Last Observation Carried Forward (LOCF)||7.6|-0.7|<0.0001
72410780|NCT01163682|144330020|NON_INFERIORITY|"This tests determined the odds of an increase of greater than or equal to 2 points on the BPI-SF worst pain score, from baseline to 16 weeks, among those in the intervention arm (electo-acupuncture), compared to those in the control arm (sham acupuncture). This change was considered to be clinically meaningful.~Null Hypothesis: electro-acupucture does not prevent taxane-induced peripheral neuropathy"|Odds Ratio (OR)|1.16||||0.25|TWO_SIDED|95.0|0.9|1.5|||Regression, Logistic|||||1.50|0.90|0.25
72410781|NCT01163682|144330021|NON_INFERIORITY|This tests determined the odds of an increase of greater than or equal to 5 points on the FACT-NTX scale, from baseline to 16 weeks, among those in the intervention arm (electo-acupuncture), compared to those in the control arm (sham acupuncture). This change was considered to be clinically meaningful.|Odds Ratio (OR)|1.25||||0.09|TWO_SIDED|95.0|0.97|1.62|||Regression, Logistic|||||1.62|0.97|0.09
72410782|NCT02504645|144330023|SUPERIORITY|||||||0.2631|TWO_SIDED|0.0|||||Chi-squared|||||||0.2631
72410783|NCT00359762|144330025|NON_INFERIORITY_OR_EQUIVALENCE|Non inferiority test was based on the upper 1-sided 97.5% CI for the hazard ratio of Exenatide/Glimepiride;the upper bound was compared to 1.25: if \<1.25, the hypothesis that the risk of treatment failure with Exenatide is more than 1.25 times greater than the risk with Glimepiride is rejected.Superiority test was based on the 2-sided 95% CI for the hazard ratio. If CI excludes 1, the hypothesis that the risk of treatment failure with Exenatide is equal to that with Glimepiride is rejected.|Hazard Ratio|0.748||||0.002|TWO_SIDED|95.0|0.623|0.899|||Regression, Cox|Time to treatment failure was modeled using Cox regression with treatment and baseline HbA1c as predictive terms.||The null hypothesis (H0) and alternative hypothesis (H1) for the primary analysis (i.e., non-inferiority) are:H0: hazards of treatment for Exenatide/hazards of treatment for Glimepiride \>=1.25.H1: hazards of treatment for Exenatide/hazards of treatment for Glimepiride \< 1.25. With 527 patients in each arm, the study would have approximately 90% power to conclude non-inferiority of Exenatide to Glimepiride.||0.899|0.623|0.0020
72410784|NCT00359762|144330026|SUPERIORITY_OR_OTHER|||||||0.0315|TWO_SIDED|99.95|||||Log Rank|||Kaplan-Meier survival curves for time to treatment failure were compared between treatment groups using log rank test.||||0.0315
72410785|NCT00359762|144330027|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-1.66|STANDARD_ERROR_OF_MEAN|5.56||0.7648|TWO_SIDED|95.0|-12.58|9.25|||Mixed Models Analysis|||Mixed-model Repeated Measures (MMRM) analysis includes treatment, visit, and treatment by visit interaction, and baseline value as a covariate. The unstructured covariance matrix was used.||9.25|-12.58|0.7648
72410786|NCT00359762|144330028|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-14.35|STANDARD_ERROR_OF_MEAN|7.399||0.0528|TWO_SIDED|95.0|-28.88|0.17|||ANCOVA|||Change in HOMA-B from baseline to endpoint was analyzed by an analysis of covariance (ANCOVA) model that includes treatment and baseline HbA1c stratum (\<=7.3%, \>7.3% to \<=8.2%, \>8.2%) as factors and baseline value as a covariate.||0.17|-28.88|0.0528
72410787|NCT00359762|144330029|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.032||0.904|TWO_SIDED|95.0|-0.07|0.06|||Mixed Models Analysis|||MMRM analysis includes treatment, visit, and treatment by visit interaction, and baseline value as a covariate. The unstructured covariance matrix was used.||0.06|-0.07|0.9040
72410788|NCT00359762|144330030|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.017||0.25|TWO_SIDED|95.0|-0.05|0.01|||ANCOVA|||Change in fasting proinsulin/insulin ratio from baseline to endpoint was analyzed by an ANCOVA model that includes treatment and baseline HbA1c stratum (\<=7.3%, \>7.3% to \<=8.2%, \>8.2%) as factors and baseline value as a covariate.||0.01|-0.05|0.2500
72410789|NCT00359762|144330031|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.56|STANDARD_ERROR_OF_MEAN|4.497||0.9001|TWO_SIDED|95.0|-9.4|8.27|||Mixed Models Analysis|||MMRM analysis includes treatment, visit, and treatment by visit interaction, and baseline value as a covariate. The unstructured covariance matrix was used.||8.27|-9.40|0.9001
72410790|NCT00359762|144330032|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|11.19|STANDARD_ERROR_OF_MEAN|4.966||0.0246|TWO_SIDED|95.0|1.44|20.95|||ANCOVA|||Change in DI30/DG30 ratio from baseline to endpoint was analyzed by an ANCOVA model that includes treatment and baseline HbA1c stratum (\<=7.3%, \>7.3% to \<=8.2%, \>8.2%) as factors and baseline value as a covariate.||20.95|1.44|0.0246
72543009|NCT00528879|144616266|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.38|STANDARD_ERROR_OF_MEAN|0.3681||||||||Sequential testing procedures were used, and no test was performed for this comparison due to the fact that the previous comparison was not significant.|ANCOVA|||||||
72543010|NCT00528879|144616266|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.19|STANDARD_ERROR_OF_MEAN|0.3745|<|0.0001||||||Statistically significant according to hierarchical testing procedure (p\<0.05).|ANCOVA|||||||<0.0001
72410791|NCT00359762|144330033|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|4.67|STANDARD_ERROR_OF_MEAN|1.598||0.0036|TWO_SIDED|95.0|1.53|7.81|||Mixed Models Analysis|||MMRM analysis includes treatment, visit, and treatment by visit interaction, and baseline value as a covariate. The unstructured covariance matrix was used.||7.81|1.53|0.0036
72410792|NCT00359762|144330034|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|7.33|STANDARD_ERROR_OF_MEAN|2.128||0.0006|TWO_SIDED|95.0|3.15|11.5|||ANCOVA|||Change in disposition index from baseline to endpoint was analyzed by an ANCOVA model that includes treatment and baseline HbA1c stratum (\<=7.3%, \>7.3% to \<=8.2%, \>8.2%) as factors and baseline value as a covariate.||11.50|3.15|0.0006
72543011|NCT00528879|144616266|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.08|STANDARD_ERROR_OF_MEAN|0.3791|<|0.0001||||||Statistically significant according to hierarchical testing procedure (p\<0.05).|ANCOVA|||||||<0.0001
72543012|NCT00528879|144616273|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.38|STANDARD_ERROR_OF_MEAN|0.1109||||||||Sequential testing procedures were used, and no test was performed for this comparison due to the fact that the previous comparison was not significant.|ANCOVA|||||||
72543013|NCT00528879|144616273|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.1129||0.0004||||||Statistically significant according to hierarchical testing procedure (p\<0.05).|ANCOVA|||||||0.0004
72410793|NCT00359762|144330035|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.07||0.0128|TWO_SIDED|95.0|-0.31|-0.04|||Mixed Models Analysis|||MMRM analysis includes treatment, visit, and treatment by visit interaction, and baseline value as a covariate. The unstructured covariance matrix was used.||-0.04|-0.31|0.0128
72410794|NCT00359762|144330036|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.05||0.0015|TWO_SIDED|95.0|-0.26|-0.06|||ANCOVA|||Change in HbA1c from baseline to endpoint was analyzed by an ANCOVA model that includes treatment as factor and baseline value as a covariate.||-0.06|-0.26|0.0015
72629138|NCT06946888|144786449|OTHER|A generalized estimating equation (GEE) model included group (intervention group vs. control group), week (categorical: 0-8), group × week interaction, and age as covariates. Robust (sandwich) standard errors were used. Regression coefficients (B), standard errors, Wald chi-squared statistics, 95% confidence intervals, and p-values for group × week comparisons are reported.||||||0.715||||||This is the fifth week of tracking data. A P value \< 0.05 indicated a statistically significant difference.|Generalized Estimating Equations, GEE|Repeated-measures GEE was used to examine the group × time interaction between week 0 and week 5.||Generalized estimating equations (GEE) were chosen over repeated-measures analysis of variance or generalized linear mixed models because they provide estimates of the population mean, are robust to correlated error specifications, can accommodate missing data under the MAR/MCAR assumptions, and do not require sphericity. All tests were two-tailed, with α = 0.05.||||0.715
72629139|NCT06946888|144786449|OTHER|A generalized estimating equation (GEE) model included group (intervention group vs. control group), week (categorical: 0-8), group × week interaction, and age as covariates. Robust (sandwich) standard errors were used. Regression coefficients (B), standard errors, Wald chi-squared statistics, 95% confidence intervals, and p-values for group × week comparisons are reported.||||||0.422||||||This is the sixth week of tracking data. A P value \< 0.05 indicated a statistically significant difference.|Generalized Estimating Equations, GEE|Repeated-measures GEE was used to examine the group × time interaction between week 0 and week 6.||Generalized estimating equations (GEE) were chosen over repeated-measures analysis of variance or generalized linear mixed models because they provide estimates of the population mean, are robust to correlated error specifications, can accommodate missing data under the MAR/MCAR assumptions, and do not require sphericity. All tests were two-tailed, with α = 0.05.||||0.422
72410795|NCT00359762|144330037|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.69|STANDARD_ERROR_OF_MEAN|0.174|<|0.0001|TWO_SIDED|95.0|-1.03|-0.34|||Mixed Models Analysis|||MMRM includes treatment, visit, and treatment by visit interaction, and baseline value as a covariate. The unstructured covariance matrix was used.||-0.34|-1.03|<.0001
72410796|NCT00359762|144330038|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.47|STANDARD_ERROR_OF_MEAN|0.183||0.0109|TWO_SIDED|95.0|-0.83|-0.11|||ANCOVA|||Change in fasting plasma glucose from baseline to endpoint was analyzed by an ANCOVA model that includes treatment and baseline HbA1c stratum (\<=7.3%, \>7.3% to \<=8.2%, \>8.2%) as factors and baseline value as a covariate.||-0.11|-0.83|0.0109
72410797|NCT00359762|144330039|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-2.8|STANDARD_ERROR_OF_MEAN|0.424|<|0.0001|TWO_SIDED|95.0|-3.64|-1.97|||Mixed Models Analysis|||MMRM analysis includes treatment, visit, and treatment by visit interaction, and baseline value as a covariate. The unstructured covariance matrix was used.||-1.97|-3.64|<.0001
72410798|NCT00359762|144330040|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-2.19|STANDARD_ERROR_OF_MEAN|0.327|<|0.0001|TWO_SIDED|95.0|-2.84|-1.55|||ANCOVA|||Change in postprandial (2 hours) plasma glucose from baseline to endpoint was analyzed by an ANCOVA model that includes treatment and baseline HbA1c stratum (\<=7.3%, \>7.3% to \<=8.2%, \>8.2%) as factors and baseline value as a covariate.||-1.55|-2.84|<.0001
72410799|NCT00359762|144330041|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-5.4|STANDARD_ERROR_OF_MEAN|0.463|<|0.0001|TWO_SIDED|95.0|-6.31|-4.49|||Mixed Models Analysis|||MMRM analysis includes treatment, visit, and treatment by visit interaction and baseline value as a covariate. The unstructured covariance matrix was used.||-4.49|-6.31|<.0001
72543014|NCT00528879|144616273|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.57|STANDARD_ERROR_OF_MEAN|0.1146|<|0.0001||||||Statistically significant according to hierarchical testing procedure (p\<0.05).|ANCOVA|||||||<0.0001
72410800|NCT00359762|144330042|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-5.2|STANDARD_ERROR_OF_MEAN|1.228|<|0.0001|TWO_SIDED|95.0|-7.61|-2.79|||Mixed Models Analysis|||MMRM analysis includes treatment, visit, and treatment by visit interaction, and baseline value as a covariate. The unstructured covariance matrix was used.||-2.79|-7.61|<.0001
72410801|NCT00359762|144330043|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-1.71|STANDARD_ERROR_OF_MEAN|0.75||0.0228|TWO_SIDED|95.0|-3.18|-0.24|||Mixed Models Analysis|||MMRM analysis includes treatment, visit, and treatment by visit interaction, and baseline value as a covariate. The unstructured covariance matrix was used.||-0.24|-3.18|0.0228
72410802|NCT00359762|144330044|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.72|STANDARD_ERROR_OF_MEAN|0.805||0.3737|TWO_SIDED|95.0|-2.3|0.86|||Mixed Models Analysis|||MMRM analysis includes treatment, visit, and visit by treatment interaction, and baseline value as a covariate. The unstructured covariance matrix was used.||0.86|-2.30|0.3737
72410803|NCT00359762|144330045|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.26|STANDARD_ERROR_OF_MEAN|0.089||0.0042|TWO_SIDED|95.0|-0.43|-0.08|||Mixed Models Analysis|||MMRM analysis includes treatment, visit, and treatment by visit interaction, and baseline value as a covariate. The unstructured covariance matrix was used.||-0.08|-0.43|0.0042
72410804|NCT00359762|144330046|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.02|STANDARD_ERROR_OF_MEAN|0.079||0.7914|TWO_SIDED|95.0|-0.13|0.18|||Mixed Models Analysis|||MMRM analysis includes treatment, visit, and treatment by visit interaction, and baseline value as a covariate. The unstructured covariance matrix was used.||0.18|-0.13|0.7914
72577640|NCT03888066|144682537|SUPERIORITY||Win Ratio|1.248|||=|0.048|TWO_SIDED|95.0|1.003|1.564|||Win Ratio|||"Win ratio for composite.~Win ratio approach: Patients in the new treatment and control groups are formed into matched pairs based on their risk profiles. For each matched pair, the new treatment patient is labelled winner/loser depending on CV/hyperkalemia event first. The win ratio is the total number of winners divided by the total numbers of losers. Unmatched win ratio is presented for this endpoint. Win ratio above 1 favors patiromer."||1.564|1.003|= 0.048
72577641|NCT05013008|144682545|OTHER|The hypotheses 'H0i: βi=0' (i=1,…,27) were tested at a two-sided significance level of 5%, where βi was the estimator for the difference in log-transformed ratios of biomarker levels of Visit 11 to Visit 3 between finerenone and placebo group for the i-th of the 27 pre-specified biomarkers.|||||=|0.001||||||Benjamini-Hochberg adjusted P-value was calculated using the log2-scaled NPX value.|t-test, 2 sided|||The NPX difference (corresponding to log-transformed ratio to baseline) of Matrilysin (P09237) was analyzed.||||= 0.001
72577642|NCT05013008|144682545|OTHER|The hypotheses 'H0i: βi=0' (i=1,…,27) were tested at a two-sided significance level of 5%, where βi was the estimator for the difference in log-transformed ratios of biomarker levels of Visit 11 to Visit 3 between finerenone and placebo group for the i-th of the 27 pre-specified biomarkers.|||||=|0.002||||||Benjamini-Hochberg adjusted P-value was calculated using the log2-scaled NPX value.|t-test, 2 sided|||The NPX difference (corresponding to log-transformed ratio to baseline) of von Willebrand factor (P04275) was analyzed.||||= 0.002
72577643|NCT05013008|144682545|OTHER|The hypotheses 'H0i: βi=0' (i=1,…,27) were tested at a two-sided significance level of 5%, where βi was the estimator for the difference in log-transformed ratios of biomarker levels of Visit 11 to Visit 3 between finerenone and placebo group for the i-th of the 27 pre-specified biomarkers.|||||=|0.044||||||Benjamini-Hochberg adjusted P-value was calculated using the log2-scaled NPX value.|t-test, 2 sided|||The NPX difference (corresponding to log-transformed ratio to baseline) of CCN family member 4 (O95388) was analyzed.||||= 0.044
72577644|NCT05013008|144682545|OTHER|The hypotheses 'H0i: βi=0' (i=1,…,27) were tested at a two-sided significance level of 5%, where βi was the estimator for the difference in log-transformed ratios of biomarker levels of Visit 11 to Visit 3 between finerenone and placebo group for the i-th of the 27 pre-specified biomarkers.|||||=|0.044||||||Benjamini-Hochberg adjusted P-value was calculated using the log2-scaled NPX value.|t-test, 2 sided|||The NPX difference (corresponding to log-transformed ratio to baseline) of TGF beta-1 proprotein (P01137) was analyzed.||||= 0.044
72577645|NCT05013008|144682545|OTHER|The hypotheses 'H0i: βi=0' (i=1,…,27) were tested at a two-sided significance level of 5%, where βi was the estimator for the difference in log-transformed ratios of biomarker levels of Visit 11 to Visit 3 between finerenone and placebo group for the i-th of the 27 pre-specified biomarkers.|||||=|0.127||||||Benjamini-Hochberg adjusted P-value was calculated using the log2-scaled NPX value.|t-test, 2 sided|||The NPX difference (corresponding to log-transformed ratio to baseline) of TGF beta receptor type 3 (Q03167) was analyzed.||||= 0.127
72577646|NCT05013008|144682545|OTHER|The hypotheses 'H0i: βi=0' (i=1,…,27) were tested at a two-sided significance level of 5%, where βi was the estimator for the difference in log-transformed ratios of biomarker levels of Visit 11 to Visit 3 between finerenone and placebo group for the i-th of the 27 pre-specified biomarkers.|||||=|0.21||||||Benjamini-Hochberg adjusted P-value was calculated using the log2-scaled NPX value.|t-test, 2 sided|||The NPX differences (corresponding to log-transformed ratio to baseline) of IL-15 receptor subunit alpha (Q13261) was analyzed.||||= 0.210
72577647|NCT05013008|144682545|OTHER|The hypotheses 'H0i: βi=0' (i=1,…,27) were tested at a two-sided significance level of 5%, where βi was the estimator for the difference in log-transformed ratios of biomarker levels of Visit 11 to Visit 3 between finerenone and placebo group for the i-th of the 27 pre-specified biomarkers.|||||=|0.215||||||Benjamini-Hochberg adjusted P-value was calculated using the log2-scaled NPX value.|t-test, 2 sided|||The NPX difference (corresponding to log-transformed ratio to baseline) of Metalloproteinase inhibitor 1 (P01033) was analyzed.||||= 0.215
72577648|NCT05013008|144682545|OTHER|The hypotheses 'H0i: βi=0' (i=1,…,27) were tested at a two-sided significance level of 5%, where βi was the estimator for the difference in log-transformed ratios of biomarker levels of Visit 11 to Visit 3 between finerenone and placebo group for the i-th of the 27 pre-specified biomarkers.|||||=|0.215||||||Benjamini-Hochberg adjusted P-value was calculated using the log2-scaled NPX value.|t-test, 2 sided|||The NPX difference (corresponding to log-transformed ratio to baseline) of Pappalysin-1 (Q13219) was analyzed.||||= 0.215
72577649|NCT05013008|144682545|OTHER|The hypotheses 'H0i: βi=0' (i=1,…,27) were tested at a two-sided significance level of 5%, where βi was the estimator for the difference in log-transformed ratios of biomarker levels of Visit 11 to Visit 3 between finerenone and placebo group for the i-th of the 27 pre-specified biomarkers.|||||=|0.745||||||Benjamini-Hochberg adjusted P-value was calculated using the log2-scaled NPX value.|t-test, 2 sided|||The NPX difference (corresponding to log-transformed ratio to baseline) of Proto-oncogene c-Src (P12931) was analyzed.||||= 0.745
72577650|NCT05013008|144682545|OTHER|The hypotheses 'H0i: βi=0' (i=1,…,27) were tested at a two-sided significance level of 5%, where βi was the estimator for the difference in log-transformed ratios of biomarker levels of Visit 11 to Visit 3 between finerenone and placebo group for the i-th of the 27 pre-specified biomarkers.|||||=|0.762||||||Benjamini-Hochberg adjusted P-value was calculated using the log2-scaled NPX value.|t-test, 2 sided|||The NPX difference (corresponding to log-transformed ratio to baseline) of Protein AMBP (P02760) was analyzed.||||= 0.762
72577651|NCT05013008|144682545|OTHER|The hypotheses 'H0i: βi=0' (i=1,…,27) were tested at a two-sided significance level of 5%, where βi was the estimator for the difference in log-transformed ratios of biomarker levels of Visit 11 to Visit 3 between finerenone and placebo group for the i-th of the 27 pre-specified biomarkers.|||||=|0.762||||||Benjamini-Hochberg adjusted P-value was calculated using the log2-scaled NPX value.|t-test, 2 sided|||The NPX difference (corresponding to log-transformed ratio to baseline) of Uromodulin (P07911) was analyzed.||||= 0.762
72410805|NCT00359762|144330047|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.06|STANDARD_ERROR_OF_MEAN|0.019||0.0011|TWO_SIDED|95.0|0.02|0.1|||Mixed Models Analysis|||MMRM analysis includes treatment, visit, and treatment by visit interaction, and baseline value as a covariate. The unstructured covariance matrix was used.||0.10|0.02|0.0011
72410806|NCT00359762|144330048|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.29|STANDARD_ERROR_OF_MEAN|0.037|<|0.0001|TWO_SIDED|95.0|0.22|0.37|||Negative Binomial Model|||The number of hypoglycemic episodes by patient were compared between treatment groups using a negative binomial model with effects for treatment and baseline HbA1c and the logarithm of the days of exposure as the offset variable.||0.37|0.22|<.0001
72410807|NCT00359762|144330049|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.28|STANDARD_ERROR_OF_MEAN|0.141||0.0508|TWO_SIDED|95.0|0.0|0.55|||Mixed Models Analysis|||MMRM analysis includes treatment, visit, and treatment by visit interaction, and baseline value at Period III as a covariate. The compound symmetric covariance structure was assumed.||0.55|-0.00|0.0508
72410808|NCT04808609|144330052|OTHER|feasibility test|Risk Ratio (RR)|1.27|STANDARD_ERROR_OF_MEAN|1.63||0.77|TWO_SIDED|95.0|0.24|6.76|||Fisher Exact|||||6.76|0.24|0.77
72410809|NCT04808609|144330053|OTHER|feasibility test|Risk Ratio (RR)|1.27|STANDARD_ERROR_OF_MEAN|0.84||0.66|TWO_SIDED|95.0|0.43|3.78|||Chi-squared|||||3.78|0.43|0.66
72410810|NCT04808609|144330054|OTHER|feasibility test|Cohen's D|0.21|STANDARD_ERROR_OF_MEAN|0.33||0.59|TWO_SIDED|95.0|-0.44|0.86|||t-test, 2 sided|||||0.86|-0.44|0.59
72410811|NCT04808609|144330054|OTHER|feasibility|Cohen's D|0.41|STANDARD_ERROR_OF_MEAN|0.17||0.02|TWO_SIDED|95.0|0.07|0.74|||t-test, 1 sided|||Results from Paired T-Test assessing the with-subject time effect on exhaled CO in ppm from baseline to 12 weeks||0.74|0.07|0.02
72410812|NCT04808609|144330055|OTHER|feasibility test|Cohen's D|0.16|STANDARD_ERROR_OF_MEAN|0.31||0.61|TWO_SIDED|95.0|-0.46|0.78|||t-test, 2 sided|||||0.78|-0.46|0.61
72410813|NCT04808609|144330056|OTHER|feasibility test|Cohen's D|0.19|STANDARD_ERROR_OF_MEAN|0.31||0.55|TWO_SIDED|95.0|-0.42|0.8|||t-test, 2 sided|||||0.80|-0.42|0.55
72410814|NCT04808609|144330057|OTHER|feasibility test|Cohen's D|0.004|STANDARD_ERROR_OF_MEAN|0.31||0.99|TWO_SIDED|95.0|-0.61|0.62|||t-test, 2 sided|||||0.62|-0.61|0.99
72410815|NCT04177693|144330083|SUPERIORITY|||||||0.112|||||||Kruskal-Wallis|||||||0.112
72410816|NCT04177693|144330084|SUPERIORITY|||||||0.613|||||||Kruskal-Wallis|||||||0.613
72410817|NCT04177693|144330085|SUPERIORITY|||||||0.202|||||||Kruskal-Wallis|||||||0.202
72329448|NCT03037476|144184382|OTHER|General Linear Model|Slope|-0.059||||0.702|TWO_SIDED|95.0|-0.363|0.245|||Mixed Models Analysis|Poisson Regression||Change in Past 3 Month Tobacco Use from Baseline to 6 Month Followup||.245|-.363|.702
72410818|NCT04177693|144330086|SUPERIORITY|||||||0.508|||||||Kruskal-Wallis|||||||0.508
72410819|NCT04177693|144330087|SUPERIORITY|||||||0.237|||||||Kruskal-Wallis|||||||0.237
72410820|NCT04177693|144330088|SUPERIORITY|||||||0.327|||||||Kruskal-Wallis|||||||0.327
72410821|NCT04177693|144330089|SUPERIORITY|||||||0.633|||||||Kruskal-Wallis|||||||0.633
72410822|NCT04177693|144330090|SUPERIORITY|||||||0.146|||||||Kruskal-Wallis|||||||0.146
72410823|NCT04177693|144330091|SUPERIORITY|||||||0.372|||||||t-test, 2 sided|||||||0.372
72410824|NCT04177693|144330092|SUPERIORITY|||||||0.07|||||||t-test, 2 sided|||||||0.07
72410825|NCT04177693|144330093|SUPERIORITY|||||||0.24|||||||t-test, 2 sided|||||||0.24
72410826|NCT04382326|144330106|NON_INFERIORITY|Comparison was conducted for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the percentage differences (20vPnC - 13vPnC) was greater than -10%.|percentage difference|-8.6|||||TWO_SIDED|95.0|-12.1|-5.1||||||Serotype 1: 2-Sided CI were calculated based on the Miettinen and Nurminen method for the difference in proportions, expressed as a percentage||-5.1|-12.1|
72410827|NCT04382326|144330106|NON_INFERIORITY|Comparison was conducted for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the percentage differences (20vPnC - 13vPnC) was greater than -10%.|percentage difference|-15.5|||||TWO_SIDED|95.0|-20.1|-10.8||||||Serotype 3: 2-Sided CI were calculated based on the Miettinen and Nurminen method for the difference in proportions, expressed as a percentage.||-10.8|-20.1|
72410828|NCT04382326|144330106|NON_INFERIORITY|Comparison was conducted for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the percentage differences (20vPnC - 13vPnC) was greater than -10%.|percentage difference|-8.4|||||TWO_SIDED|95.0|-12.0|-4.9||||||Serotype 4: 2-Sided CI were calculated based on the Miettinen and Nurminen method for the difference in proportions, expressed as a percentage||-4.9|-12.0|
72410829|NCT04382326|144330106|NON_INFERIORITY|Comparison was conducted for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the percentage differences (20vPnC - 13vPnC) was greater than -10%.|percentage difference|-4.3|||||TWO_SIDED|95.0|-7.8|-0.8||||||Serotype 5: 2-Sided CI were calculated based on the Miettinen and Nurminen method for the difference in proportions, expressed as a percentage||-0.8|-7.8|
72410830|NCT04382326|144330106|NON_INFERIORITY|Comparison was conducted for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the percentage differences (20vPnC - 13vPnC) was greater than -10%.|percentage difference|-2.4|||||TWO_SIDED|95.0|-4.6|-0.2||||||Serotype 6A: 2-Sided CI were calculated based on the Miettinen and Nurminen method for the difference in proportions, expressed as a percentage||-0.2|-4.6|
72543015|NCT00528879|144616274|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.1|STANDARD_ERROR_OF_MEAN|2.769||||||||Sequential testing procedures were used, and no test was performed for this comparison due to the fact that the previous comparison was not significant.|ANCOVA|||||||
72543016|NCT00528879|144616274|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.1|STANDARD_ERROR_OF_MEAN|2.762|<|0.0001||||||Statistically significant according to hierarchical testing procedure (p\<0.05).|ANCOVA|||||||<0.0001
72543017|NCT00528879|144616274|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.7|STANDARD_ERROR_OF_MEAN|2.808|<|0.0001||||||Statistically significant according to hierarchical testing procedure (p\<0.05).|ANCOVA|||||||<0.0001
72543018|NCT00528879|144616275|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.9||||||||||Sequential testing procedures were used, and no test was performed for this comparison due to the fact that the previous comparison was not significant.|Modified logistic regression|||||||
72543019|NCT00528879|144616275|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.7||||0.8627|||||||Modified logistic regression|||||||0.8627
72543020|NCT00528879|144616275|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.3||||0.0149||||||Statistically significant according to hierarchical testing procedure (p\<0.05).|Modified logistic regression|||||||0.0149
72543021|NCT00078819|144616276|SUPERIORITY|The significance levels for primary and secondary efficacy end points were controlled at 0.05 with the use of a sequential testing scheme in this order: PASI 75, PASI 50, a physician's global assessment of clear or almost clear, percentage improvement from baseline in CDLQI, and PASI 90.|||||<|0.0001|||||||Cochran-Mantel-Haenszel|Two-sided Cochran-Mantel-Haenszel test stratified by age group||||||<0.0001
72543022|NCT00078819|144616277|SUPERIORITY|The significance levels for primary and secondary efficacy end points were controlled at 0.05 with the use of a sequential testing scheme in this order: PASI 75, PASI 50, a physician's global assessment of clear or almost clear, percentage improvement from baseline in CDLQI, and PASI 90.|||||<|0.0001|||||||Cochran-Mantel-Haenszel|Two-sided Cochran-Mantel-Haenszel test stratified by age group||||||<0.0001
72543023|NCT00078819|144616278|SUPERIORITY|The significance levels for primary and secondary efficacy end points were controlled at 0.05 with the use of a sequential testing scheme in this order: PASI 75, PASI 50, a physician's global assessment of clear or almost clear, percentage improvement from baseline in CDLQI, and PASI 90.|||||<|0.0001|||||||Cochran-Mantel-Haenszel|Two-sided Cochran-Mantel-Haenszel test stratified by age group||||||<0.0001
72543024|NCT00078819|144616279|SUPERIORITY|The significance levels for primary and secondary efficacy end points were controlled at 0.05 with the use of a sequential testing scheme in this order: PASI 75, PASI 50, a physician's global assessment of clear or almost clear, percentage improvement from baseline in CDLQI, and PASI 90.|||||<|0.0001|||||||Van Elteren test|Two-sided van Elteren's test stratified by age group||||||<0.0001
72543025|NCT00078819|144616280|SUPERIORITY|The significance levels for primary and secondary efficacy end points were controlled at 0.05 with the use of a sequential testing scheme in this order: PASI 75, PASI 50, a physician's global assessment of clear or almost clear, percentage improvement from baseline in CDLQI, and PASI 90.|||||<|0.0001|||||||Cochran-Mantel-Haenszel|Two-sided Cochran-Mantel-Haenszel test stratified by age group||||||<0.0001
72543026|NCT00323609|144616289|SUPERIORITY_OR_OTHER|||||||0.214||95.0|||||Fisher Exact|||||||0.214
72543027|NCT00323609|144616290|SUPERIORITY_OR_OTHER|||||||0.43||95.0||||P-value was obtained from ANCOVA with baseline value as covariate.|ANCOVA|||Statistical analysis at 7 days.||||0.430
72543028|NCT00323609|144616290|SUPERIORITY_OR_OTHER|||||||0.655||95.0||||P-value was obtained from ANCOVA with baseline value as covariate.|ANCOVA|||Statistical analysis at 30 days.||||0.655
72543029|NCT00323609|144616290|SUPERIORITY_OR_OTHER|||||||0.756||95.0||||P-value was obtained from ANCOVA with baseline value as covariate.|ANCOVA|||Statistical analysis at 3 months.||||0.756
72543030|NCT00323609|144616290|SUPERIORITY_OR_OTHER|||||||0.503||95.0||||P-value was obtained from ANCOVA with baseline value as covariate.|ANCOVA|||Statistical analysis at 12 months.||||0.503
72543031|NCT00323609|144616290|SUPERIORITY_OR_OTHER|||||||0.837||95.0||||P-value was obtained from ANCOVA with baseline value as covariate.|ANCOVA|||Statistical analysis at 24 months.||||0.837
72543032|NCT00323609|144616291|SUPERIORITY_OR_OTHER|||||||0.785||95.0||||P-value was obtained from ANCOVA with baseline value as covariate.|ANCOVA|||Statistical analysis at 30 days||||0.785
72543033|NCT00323609|144616291|SUPERIORITY_OR_OTHER|||||||0.393||95.0||||P-value was obtained from ANCOVA with baseline value as covariate.|ANCOVA|||Statistical analysis at 3 months.||||0.393
72543034|NCT00323609|144616291|SUPERIORITY_OR_OTHER|||||||0.875||95.0||||P-value was obtained from ANCOVA with baseline value as covariate.|ANCOVA|||Statistical analysis at 12 months||||0.875
72543035|NCT00323609|144616291|SUPERIORITY_OR_OTHER|||||||0.833||95.0||||P-value was obtained from ANCOVA with baseline value as covariate.|ANCOVA|||Statistical analysis at 24 months.||||0.833
72543036|NCT00323609|144616292|SUPERIORITY_OR_OTHER|||||||0.18||95.0||||P-value was obtained from ANCOVA with baseline value as covariate.|ANCOVA|||Statistical analysis of SF-36 PCS result at 30 days.||||0.180
72543037|NCT00323609|144616292|SUPERIORITY_OR_OTHER|||||||0.822||95.0||||P-value was obtained from ANCOVA with baseline value as covariate.|ANCOVA|||Statistical analysis of SF-36 PCS result at 3 months||||0.822
72543038|NCT00323609|144616292|SUPERIORITY_OR_OTHER|||||||0.291||95.0||||P-value was obtained from ANCOVA with baseline value as covariate.|ANCOVA|||Statistical analysis of SF-36 PCS result at 12 months||||0.291
72543039|NCT00323609|144616292|SUPERIORITY_OR_OTHER|||||||0.996||95.0||||P-value was obtained from ANCOVA with baseline value as covariate.|ANCOVA|||Statistical analysis of SF-36 PCS result at 24 months||||0.996
72543040|NCT00323609|144616292|SUPERIORITY_OR_OTHER|||||||0.983||95.0||||P-value was obtained from ANCOVA with baseline value as covariate.|ANCOVA|||Statistical analysis of SF-36 MCS result at 30 days||||0.983
72543041|NCT00323609|144616292|SUPERIORITY_OR_OTHER|||||||0.576||95.0||||P-value was obtained from ANCOVA with baseline value as covariate.|ANCOVA|||Statistical analysis of SF-36 MCS result at 3 months||||0.576
72543042|NCT00323609|144616292|SUPERIORITY_OR_OTHER|||||||0.393||95.0||||P-value was obtained from ANCOVA with baseline value as covariate.|ANCOVA|||Statistical analysis of SF-36 MCS result at 12 months||||0.393
72543043|NCT00323609|144616292|SUPERIORITY_OR_OTHER|||||||0.722||95.0||||P-value was obtained from ANCOVA with baseline value as covariate.|ANCOVA|||Statistical analysis of SF-36 MCS result at 24 months||||0.722
72543044|NCT00323609|144616293|SUPERIORITY_OR_OTHER|||||||0.318||95.0||||P-value was obtained from ANCOVA with baseline value as covariate.|ANCOVA|||Statistical analysis at 30 days.||||0.318
72543045|NCT00323609|144616293|SUPERIORITY_OR_OTHER|||||||0.523||95.0||||P-value was obtained from ANCOVA with baseline value as covariate.|ANCOVA|||Statistical analysis at 3 months.||||0.523
72543046|NCT00323609|144616293|SUPERIORITY_OR_OTHER|||||||0.634||95.0||||P-value was obtained from ANCOVA with baseline value as covariate.|ANCOVA|||Statistical analysis at 12 months.||||0.634
72543047|NCT00323609|144616293|SUPERIORITY_OR_OTHER|||||||0.457||95.0||||P-value was obtained from ANCOVA with baseline value as covariate.|ANCOVA|||Statistical analysis at 24 months.||||0.457
72543048|NCT00323609|144616294|SUPERIORITY_OR_OTHER|||||||0.818||95.0|||||Fisher Exact|||||||0.818
72543049|NCT00323609|144616295|SUPERIORITY_OR_OTHER|||||||0.226||95.0|||||Fisher Exact|||||||0.226
72543050|NCT00323609|144616296|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|||||||1.0
72410831|NCT04382326|144330106|NON_INFERIORITY|Comparison was conducted for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the percentage differences (20vPnC - 13vPnC) was greater than -10%.|percentage difference|-4.1|||||TWO_SIDED|95.0|-7.0|-1.2||||||Serotype 6B: 2-Sided CI were calculated based on the Miettinen and Nurminen method for the difference in proportions, expressed as a percentage||-1.2|-7.0|
72543051|NCT00323609|144616297|SUPERIORITY_OR_OTHER|||||||0.112||95.0||||P-value was obtained from ANCOVA with Absolute Height Loss (AHL) as covariate.|ANCOVA|||Statistical analysis at pre-discharge.||||0.112
72543052|NCT00323609|144616297|SUPERIORITY_OR_OTHER|||||||0.364||95.0||||P-value was obtained from ANCOVA with Absolute Height Loss (AHL) as covariate.|ANCOVA|||Statistical analysis at 3 months.||||0.364
72629140|NCT06946888|144786449|OTHER|A generalized estimating equation (GEE) model included group (intervention group vs. control group), week (categorical: 0-8), group × week interaction, and age as covariates. Robust (sandwich) standard errors were used. Regression coefficients (B), standard errors, Wald chi-squared statistics, 95% confidence intervals, and p-values for group × week comparisons are reported.||||||0.379||||||This is the seventh week of tracking data. A P value \< 0.05 indicated a statistically significant difference.|Generalized Estimating Equations, GEE|Repeated-measures GEE was used to examine the group × time interaction between week 0 and week 7.||Generalized estimating equations (GEE) were chosen over repeated-measures analysis of variance or generalized linear mixed models because they provide estimates of the population mean, are robust to correlated error specifications, can accommodate missing data under the MAR/MCAR assumptions, and do not require sphericity. All tests were two-tailed, with α = 0.05.||||0.379
72629141|NCT06946888|144786449|OTHER|A generalized estimating equation (GEE) model included group (intervention group vs. control group), week (categorical: 0-8), group × week interaction, and age as covariates. Robust (sandwich) standard errors were used. Regression coefficients (B), standard errors, Wald chi-squared statistics, 95% confidence intervals, and p-values for group × week comparisons are reported.||||||0.302||||||This is the eighth week of tracking data. A P value \< 0.05 indicated a statistically significant difference.|Generalized Estimating Equations, GEE|Repeated-measures GEE was used to examine the group × time interaction between week 0 and week 8.||Generalized estimating equations (GEE) were chosen over repeated-measures analysis of variance or generalized linear mixed models because they provide estimates of the population mean, are robust to correlated error specifications, can accommodate missing data under the MAR/MCAR assumptions, and do not require sphericity. All tests were two-tailed, with α = 0.05.||||0.302
72543053|NCT00323609|144616297|SUPERIORITY_OR_OTHER|||||||0.185||95.0||||P-value was obtained from ANCOVA with Absolute Height Loss (AHL) as covariate.|ANCOVA|||Statistical analysis at 12 months.||||0.185
72543054|NCT00323609|144616297|SUPERIORITY_OR_OTHER|||||||0.1||95.0||||P-value was obtained from ANCOVA with Absolute Height Loss (AHL) as covariate.|ANCOVA|||Statistical analysis at 24 months.||||0.100
72543055|NCT00323609|144616298|SUPERIORITY_OR_OTHER|||||||0.005||95.0||||P-value was obtained from ANCOVA with Absolute Height Loss (AHL) as covariate.|ANCOVA|||Statistical analysis at pre-discharge.||||0.005
72543056|NCT00323609|144616298|SUPERIORITY_OR_OTHER|||||||0.382||95.0||||P-value was obtained from ANCOVA with Absolute Height Loss (AHL) as covariate.|ANCOVA|||Statistical analysis at 3 months.||||0.382
72577652|NCT05013008|144682545|OTHER|The hypotheses 'H0i: βi=0' (i=1,…,27) were tested at a two-sided significance level of 5%, where βi was the estimator for the difference in log-transformed ratios of biomarker levels of Visit 11 to Visit 3 between finerenone and placebo group for the i-th of the 27 pre-specified biomarkers.|||||=|0.762||||||Benjamini-Hochberg adjusted P-value was calculated using the log2-scaled NPX value.|t-test, 2 sided|||The NPX difference (corresponding to log-transformed ratio to baseline) of Aminopeptidase N (P15144) was analyzed.||||= 0.762
72577653|NCT05013008|144682545|OTHER|The hypotheses 'H0i: βi=0' (i=1,…,27) were tested at a two-sided significance level of 5%, where βi was the estimator for the difference in log-transformed ratios of biomarker levels of Visit 11 to Visit 3 between finerenone and placebo group for the i-th of the 27 pre-specified biomarkers.|||||=|0.762||||||Benjamini-Hochberg adjusted P-value was calculated using the log2-scaled NPX value.|t-test, 2 sided|||The NPX difference (corresponding to log-transformed ratio to baseline) of TNFRSF1A (P19438) was analyzed.||||= 0.762
72577654|NCT05013008|144682545|OTHER|The hypotheses 'H0i: βi=0' (i=1,…,27) were tested at a two-sided significance level of 5%, where βi was the estimator for the difference in log-transformed ratios of biomarker levels of Visit 11 to Visit 3 between finerenone and placebo group for the i-th of the 27 pre-specified biomarkers.|||||=|0.917||||||Benjamini-Hochberg adjusted P-value was calculated using the log2-scaled NPX value.|t-test, 2 sided|||The NPX difference (corresponding to log-transformed ratio to baseline) of Plasminogen activator inhibitor 1 (P05121) was analyzed.||||= 0.917
72577655|NCT05013008|144682545|OTHER|The hypotheses 'H0i: βi=0' (i=1,…,27) were tested at a two-sided significance level of 5%, where βi was the estimator for the difference in log-transformed ratios of biomarker levels of Visit 11 to Visit 3 between finerenone and placebo group for the i-th of the 27 pre-specified biomarkers.|||||=|0.917||||||Benjamini-Hochberg adjusted P-value was calculated using the log2-scaled NPX value.|t-test, 2 sided|||The NPX difference (corresponding to log-transformed ratio to baseline) of CCN family member 2 (P29279) was analyzed.||||= 0.917
72577656|NCT05013008|144682545|OTHER|The hypotheses 'H0i: βi=0' (i=1,…,27) were tested at a two-sided significance level of 5%, where βi was the estimator for the difference in log-transformed ratios of biomarker levels of Visit 11 to Visit 3 between finerenone and placebo group for the i-th of the 27 pre-specified biomarkers.|||||=|0.917||||||Benjamini-Hochberg adjusted P-value was calculated using the log2-scaled NPX value.|t-test, 2 sided|||The NPX difference (corresponding to log-transformed ratio to baseline) of uPAR (Q03405) was analyzed.||||= 0.917
72577657|NCT05013008|144682545|OTHER|The hypotheses 'H0i: βi=0' (i=1,…,27) were tested at a two-sided significance level of 5%, where βi was the estimator for the difference in log-transformed ratios of biomarker levels of Visit 11 to Visit 3 between finerenone and placebo group for the i-th of the 27 pre-specified biomarkers.|||||=|0.917||||||Benjamini-Hochberg adjusted P-value was calculated using the log2-scaled NPX value.|t-test, 2 sided|||The NPX difference (corresponding to log-transformed ratio to baseline) of C-C motif chemokine 14 (Q16627) was analyzed.||||= 0.917
72410832|NCT04382326|144330106|NON_INFERIORITY|Comparison was conducted for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the percentage differences (20vPnC - 13vPnC) was greater than -10%.|percentage difference|-1.0|||||TWO_SIDED|95.0|-2.7|0.7||||||Serotype 7F: 2-sided CI were calculated based on the Miettinen and Nurminen method for the difference in proportions, expressed as a percentage||0.7|-2.7|
72410833|NCT04382326|144330106|NON_INFERIORITY|Comparison was conducted for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the percentage differences (20vPnC - 13vPnC) was greater than -10%.|percentage difference|-7.9|||||TWO_SIDED|95.0|-11.3|-4.6||||||Serotype 9V: 2-Sided CI were calculated based on the Miettinen and Nurminen method for the difference in proportions, expressed as a percentage||-4.6|-11.3|
72410834|NCT04382326|144330106|NON_INFERIORITY|Comparison was conducted for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the percentage differences (20vPnC - 13vPnC) was greater than -10%.|percentage difference|-0.8|||||TWO_SIDED|95.0|-3.1|1.6||||||Serotype 14: 2-Sided CI were calculated based on the Miettinen and Nurminen method for the difference in proportions, expressed as a percentage||1.6|-3.1|
72410835|NCT04382326|144330106|NON_INFERIORITY|Comparison was conducted for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the percentage differences (20vPnC - 13vPnC) was greater than -10%.|percentage difference|-0.6|||||TWO_SIDED|95.0|-3.1|1.9||||||Serotype 18C: 2-Sided CI were calculated based on the Miettinen and Nurminen method for the difference in proportions, expressed as a percentage||1.9|-3.1|
72410836|NCT04382326|144330106|NON_INFERIORITY|Comparison was conducted for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the percentage differences (20vPnC - 13vPnC) was greater than -10%.|percentage difference|-1.0|||||TWO_SIDED|95.0|-2.6|0.5||||||Serotype 19A: 2-Sided CI were calculated based on the Miettinen and Nurminen method for the difference in proportions, expressed as a percentage||0.5|-2.6|
72410837|NCT04382326|144330106|NON_INFERIORITY|Comparison was conducted for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the percentage differences (20vPnC - 13vPnC) was greater than -10%.|percentage difference|0.2|||||TWO_SIDED|95.0|-1.5|2.0||||||Serotype 19F: 2-Sided CI were calculated based on the Miettinen and Nurminen method for the difference in proportions, expressed as a percentage||2.0|-1.5|
72410838|NCT04382326|144330106|NON_INFERIORITY|Comparison was conducted for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the percentage differences (20vPnC - 13vPnC) was greater than -10%.|percentage difference|-7.6|||||TWO_SIDED|95.0|-11.4|-3.9||||||Serotype 23F: 2-Sided CI were calculated based on the Miettinen and Nurminen method for the difference in proportions, expressed as a percentage||-3.9|-11.4|
72410839|NCT04382326|144330106|NON_INFERIORITY|For the additional 7 serotypes, the compared results were from serotype 23F (13vPnC serotype with the lowest percentage, not including serotype 3) in the 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the percentage differences (20vPnC - lowest 13vPnC) was greater than -10%.|percentage difference|11.2|||||TWO_SIDED|95.0|8.6|14.0||||||Serotype 8: 2-Sided CI were calculated based on the Miettinen and Nurminen method for the difference in proportions, expressed as a percentage||14.0|8.6|
72410840|NCT04382326|144330106|NON_INFERIORITY|For the additional 7 serotypes, the compared results were from serotype 23F (13vPnC serotype with the lowest percentage, not including serotype 3) in the 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the percentage differences (20vPnC - lowest 13vPnC) was greater than -10%.|percentage difference|-3.3|||||TWO_SIDED|95.0|-6.9|0.3||||||Serotype 10A: 2-Sided CI were calculated based on the Miettinen and Nurminen method for the difference in proportions, expressed as a percentage||0.3|-6.9|
72410841|NCT04382326|144330106|NON_INFERIORITY|For the additional 7 serotypes, the compared results were from serotype 23F (13vPnC serotype with the lowest percentage, not including serotype 3) in the 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the percentage differences (20vPnC - lowest 13vPnC) was greater than -10%.|percentage difference|7.1||||||95.0|4.2|10.2||||||Serotype 11A: 2-Sided CI were calculated based on the Miettinen and Nurminen method for the difference in proportions, expressed as a percentage||10.2|4.2|
72410842|NCT04382326|144330106|NON_INFERIORITY|For the additional 7 serotypes, the compared results were from serotype 23F (13vPnC serotype with the lowest percentage, not including serotype 3) in the 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the percentage differences (20vPnC - lowest 13vPnC) was greater than -10%.|percentage difference|-18.1|||||TWO_SIDED|95.0|-22.1|-14.0||||||Serotype 12F: 2-Sided CI were calculated based on the Miettinen and Nurminen method for the difference in proportions, expressed as a percentage||-14.0|-22.1|
72543057|NCT00323609|144616298|SUPERIORITY_OR_OTHER|||||||0.196||95.0||||P-value was obtained from ANCOVA with Absolute Height Loss (AHL) as covariate.|ANCOVA|||Statistical analysis at 12 months.||||0.196
72543058|NCT00323609|144616298|SUPERIORITY_OR_OTHER|||||||0.281||95.0||||P-value was obtained from ANCOVA with Absolute Height Loss (AHL) as covariate.|ANCOVA|||Statistical analysis at 24 months.||||0.281
72543059|NCT00323609|144616299|SUPERIORITY_OR_OTHER|||||||0.033||95.0||||P-value was obtained from ANCOVA with Absolute Height Loss (AHL) as covariate.|ANCOVA|||Statistical analysis at pre-discharge.||||0.033
72543060|NCT00323609|144616299|SUPERIORITY_OR_OTHER|||||||0.981||95.0||||P-value was obtained from ANCOVA with Absolute Height Loss (AHL) as covariate.|ANCOVA|||Statistical analysis at 3 months.||||0.981
72543061|NCT00323609|144616299|SUPERIORITY_OR_OTHER|||||||0.631||95.0||||P-value was obtained from ANCOVA with Absolute Height Loss (AHL) as covariate.|ANCOVA|||Statistical analysis at 12 months.||||0.631
72543062|NCT00323609|144616299|SUPERIORITY_OR_OTHER|||||||0.79||95.0||||P-value was obtained from ANCOVA with Absolute Height Loss (AHL) as covariate.|ANCOVA|||Statistical analysis at 24 months.||||0.790
72543063|NCT00323609|144616300|SUPERIORITY_OR_OTHER|||||||0.663||95.0||||P-value was obtained from ANCOVA with baseline value as covariate.|ANCOVA|||Statistical analysis at pre-discharge.||||0.663
72543064|NCT00323609|144616300|SUPERIORITY_OR_OTHER|||||||0.933||95.0||||P-value was obtained from ANCOVA with baseline value as covariate.|ANCOVA|||Statistical analysis at 3 months.||||0.933
72410843|NCT04382326|144330106|NON_INFERIORITY|For the additional 7 serotypes, the compared results were from serotype 23F (13vPnC serotype with the lowest percentage, not including serotype 3) in the 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the percentage differences (20vPnC - lowest 13vPnC) was greater than -10%.|percentage difference|12.7|||||TWO_SIDED|95.0|10.2|15.4||||||Serotype 15B: 2-Sided CI were calculated based on the Miettinen and Nurminen method for the difference in proportions, expressed as a percentage||15.4|10.2|
72410844|NCT04382326|144330106|NON_INFERIORITY|For the additional 7 serotypes, the compared results were from serotype 23F (13vPnC serotype with the lowest percentage, not including serotype 3) in the 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the percentage differences (20vPnC - lowest 13vPnC) was greater than -10%.|percentage difference|12.8|||||TWO_SIDED|95.0|10.3|15.5||||||Serotype 22F: 2-Sided CI were calculated based on the Miettinen and Nurminen method for the difference in proportions, expressed as a percentage||15.5|10.3|
72410845|NCT04382326|144330106|NON_INFERIORITY|For the additional 7 serotypes, the compared results were from serotype 23F (13vPnC serotype with the lowest percentage, not including serotype 3) in the 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the percentage differences (20vPnC - lowest 13vPnC) was greater than -10%.|percentage difference|1.1|||||TWO_SIDED|95.0|-2.2|4.5||||||Serotype 33F: 2-Sided CI were calculated based on the Miettinen and Nurminen method for the difference in proportions, expressed as a percentage||4.5|-2.2|
72410846|NCT04382326|144330107|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC was to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the IgG GMR of 20vPnC to 13vPnC for the serotype is greater than 0.5 (2-fold NI margin).|Geometric Mean Ratio|0.69|||||TWO_SIDED|95.0|0.63|0.76||||||Serotype 1: GMR and 2-Sided CI were calculated by exponentiating the mean difference (20vPnC-13vPnC) of the logarithms of the IgG concentrations and the corresponding CI (based on the Student's t distribution).||0.76|0.63|
72410847|NCT04382326|144330107|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC was to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the IgG GMR of 20vPnC to 13vPnC for the serotype is greater than 0.5 (2-fold NI margin).|Geometric Mean Ratio|0.66|||||TWO_SIDED|95.0|0.61|0.73||||||Serotype 3: GMR and 2-Sided CI were calculated by exponentiating the mean difference (20vPnC-13vPnC) of the logarithms of the IgG concentrations and the corresponding CI (based on the Student's t distribution).||0.73|0.61|
72410848|NCT04382326|144330107|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC was to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the IgG GMR of 20vPnC to 13vPnC for the serotype is greater than 0.5 (2-fold NI margin).|Geometric Mean Ratio|0.78||||||95.0|0.7|0.86||||||Serotype 4: GMR and 2-Sided CI were calculated by exponentiating the mean difference (20vPnC-13vPnC) of the logarithms of the IgG concentrations and the corresponding CI (based on the Student's t distribution).||0.86|0.70|
72410849|NCT04382326|144330107|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC was to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the IgG GMR of 20vPnC to 13vPnC for the serotype is greater than 0.5 (2-fold NI margin).|Geometric Mean Ratio|0.74|||||TWO_SIDED|95.0|0.67|0.82||||||Serotype 5: GMR and 2-Sided CI were calculated by exponentiating the mean difference (20vPnC-13vPnC) of the logarithms of the IgG concentrations and the corresponding CI (based on the Student's t distribution).||0.82|0.67|
72410850|NCT04382326|144330107|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC was to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the IgG GMR of 20vPnC to 13vPnC for the serotype is greater than 0.5 (2-fold NI margin).|Geometric Mean Ratio|0.77|||||TWO_SIDED|95.0|0.7|0.85||||||Serotype 6A: GMR and 2-Sided CI were calculated by exponentiating the mean difference (20vPnC-13vPnC) of the logarithms of the IgG concentrations and the corresponding CI (based on the Student's t distribution).||0.85|0.70|
72410851|NCT04382326|144330107|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC was to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the IgG GMR of 20vPnC to 13vPnC for the serotype is greater than 0.5 (2-fold NI margin).|Geometric Mean Ratio|0.7|||||TWO_SIDED|95.0|0.62|0.79||||||Serotype 6B: GMR and 2-Sided CI were calculated by exponentiating the mean difference (20vPnC-13vPnC) of the logarithms of the IgG concentrations and the corresponding CI (based on the Student's t distribution).||0.79|0.62|
72543065|NCT00323609|144616300|SUPERIORITY_OR_OTHER|||||||0.089||95.0||||P-value was obtained from ANCOVA with baseline value as covariate.|ANCOVA|||Statistical analysis at 12 months.||||0.089
72410852|NCT04382326|144330107|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC was to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the IgG GMR of 20vPnC to 13vPnC for the serotype is greater than 0.5 (2-fold NI margin).|Geometric Mean Ratio|0.76|||||TWO_SIDED|95.0|0.7|0.82||||||Serotype 7F: GMR and 2-Sided CI were calculated by exponentiating the mean difference (20vPnC-13vPnC) of the logarithms of the IgG concentrations and the corresponding CI (based on the Student's t distribution).||0.82|0.70|
72421517|NCT01342458|144354200|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||We used a casewise two-way ANOVA for repeated measures (two independent groups and three repeated measures/assessments), followed by a post hoc Newman-Keuls test to verify the interaction effect of group vs. time between T0 (baseline), T3 (3th month) and T6 (6th month).||||<0.001
72543066|NCT00323609|144616300|SUPERIORITY_OR_OTHER|||||||0.036||95.0||||P-value was obtained from ANCOVA with baseline value as covariate.|ANCOVA|||Statistical analysis at 24 months.||||0.036
72543067|NCT00323609|144616301|SUPERIORITY_OR_OTHER|||||||0.472||95.0||||P-value was obtained from ANCOVA with baseline value as covariate.|ANCOVA|||Statistical analysis at pre-discharge.||||0.472
72543068|NCT00323609|144616301|SUPERIORITY_OR_OTHER|||||||0.745||95.0||||P-value was obtained from ANCOVA with baseline value as covariate.|ANCOVA|||Statistical analysis at 3 months.||||0.745
72543069|NCT00323609|144616301|SUPERIORITY_OR_OTHER|||||||0.565||95.0||||P-value was obtained from ANCOVA with baseline value as covariate.|ANCOVA|||Statistical analysis at 12 months.||||0.565
72410853|NCT04382326|144330107|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC was to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the IgG GMR of 20vPnC to 13vPnC for the serotype is greater than 0.5 (2-fold NI margin).|Geometric Mean Ratio|0.8||||||95.0|0.73|0.88||||||Serotype 9V: GMR and 2-Sided CI were calculated by exponentiating the mean difference (20vPnC-13vPnC) of the logarithms of the IgG concentrations and the corresponding CI (based on the Student's t distribution).||0.88|0.73|
72543070|NCT00323609|144616301|SUPERIORITY_OR_OTHER|||||||0.687||95.0||||P-value was obtained from ANCOVA with baseline value as covariate.|ANCOVA|||Statistical analysis at 24 months.||||0.687
72543071|NCT00267293|144616306|NON_INFERIORITY_OR_EQUIVALENCE|Power for 80%|||||<|0.001||||||comparision of mean temperatures from repeated exposure. At hour 6 temperature|Mixed Models Analysis|||Power for 80%||||<0.001
72543072|NCT00267293|144616306|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Binary outcome \<38C and \>=38C|Chi-squared|||||||<.0001
72543073|NCT00950599|144616307|SUPERIORITY_OR_OTHER|||||||0.9888||95.0||||A significance level of alpha = 0.05 was used for the trend test.|Kruskal-Wallis|ANCOVA Model: post-pre=pre treatment.||A test for log-linear trend across saxagliptin doses was performed using a linear contrast among the saxagliptin doses from an analysis of covariance (ANCOVA) model. The ANCOVA model was the same model used for the first secondary endpoint.||||0.9888
72543074|NCT00950599|144616308|SUPERIORITY_OR_OTHER|||||||0.9888||95.0||||Positive efficacy trend among doses of saxagliptin by assessing the adjusted mean change from baseline in A1C in the 0-40 mg cohort.|ANCOVA|ANCOVA Model: post-pre=pretreatment. Contrast Coefficients: -2, -1, 0, 1 2.||||||0.9888
72543075|NCT03803085|144616401|SUPERIORITY|||||||0.02|||||||Mixed Models Analysis|||||||0.02
72543076|NCT03803085|144616402|SUPERIORITY|||||||0.03|||||||Mixed Models Analysis|||||||0.03
72543077|NCT03803085|144616403|SUPERIORITY|||||||0.06||||||p\<0.05 was considered significant.|Mixed Models Analysis|||||||0.06
72543078|NCT01684722|144616412|SUPERIORITY||Mean Difference (Final Values)|0.9||||0.25|TWO_SIDED|95.0|-0.7|2.5|||Mixed Models Analysis|||||2.5|-0.7|0.25
72543079|NCT01684722|144616412|SUPERIORITY||Mean Difference (Final Values)|0.9||||0.27|TWO_SIDED|95.0|-0.7|2.6|||Mixed Models Analysis|||||2.6|-0.7|0.27
72543080|NCT01684722|144616413|SUPERIORITY||Ratio of change from baseline, active to|0.99||||0.9|TWO_SIDED|95.0|0.84|1.17|||Mixed Models Analysis|||||1.17|0.84|0.90
72543081|NCT01684722|144616413|SUPERIORITY||Ratio of change from baseline, active to|0.96||||0.64|TWO_SIDED|95.0|0.81|1.14|||Mixed Models Analysis|||||1.14|0.81|0.64
72543082|NCT03979677|144616420|OTHER|HDI and DHI analyzed using linear mixed-effects models with two within-participant factors, Intervention (pre-intervention, post-intervention) and Inventory (DHI, HDI). All models included participant as a random factor. Models constructed using lmer function of the lme package in R and analyzed using anova function in base R. Significant main effects and interactions were evaluated using emmeans . Pairwise comparisons were adjusted to account for false-discovery rates.|||||<|0.0001||||||Multiple comparisons were adjusted.|linear mixed-effects models|||||||<.0001
72543083|NCT03979677|144616421|OTHER|HDI and DHI analyzed using linear mixed-effects models with two within-participant factors, Intervention (pre-intervention, post-intervention) and Inventory (DHI, HDI). All models included participant as a random factor. Models constructed using lmer function of the lme package in R and analyzed using anova function in base R. Significant main effects and interactions were evaluated using emmeans . Pairwise comparisons were adjusted to account for false-discovery rates.|||||<|0.0001||||||Point change in DHI was tests.|linear mixed-effects models|||||||<.0001
72543084|NCT00479401|144616436|NON_INFERIORITY_OR_EQUIVALENCE|A non-inferiority hypothesis comparing pramipexole ER to pramipexole IR was to be tested using a non-inferiority margin of -3 points. The primary efficacy endpoint in UPDRS part II+III was the change from baseline (week 0) to week 33 on the UPDRS Parts II+III score combined. The statistical model was analysis of covariance, controlling for baseline UPDRS Part II+III. Fixed terms in the model were treatment, country, and UPDRS Part II+III score at baseline.|Mean Difference (Final Values)|-0.2|||||TWO_SIDED|95.0|-2.2|1.7|||ANCOVA|Null hypothesis was tested using an analysis of covariance model with α = 0.05 in full analysis set with last observation carried forward.|PPX ER non-inferior to PPX IR, if the lower limit of the confidence interval for the difference is higher than the non-inferiority margin of -3|A non-inferiority hypothesis (H0: μER - μIR \< -3 vs. H1: μER - μIR ≥ -3) comparing pramipexole ER to pramipexole IR was tested using a non-inferiority margin of -3 points.||1.7|-2.2|
72543085|NCT00947765|144616484|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.0001
72543086|NCT00947765|144616485|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.0001
72543087|NCT00947765|144616486|SUPERIORITY_OR_OTHER|||||||0.0022||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0022
72543088|NCT00947765|144616487|SUPERIORITY_OR_OTHER|||||||0.003||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.003
72543089|NCT00947765|144616488|SUPERIORITY_OR_OTHER|||||||0.0127||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0127
72543090|NCT00947765|144616489|SUPERIORITY_OR_OTHER|||||||0.0184||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0184
72543091|NCT00947765|144616490|SUPERIORITY_OR_OTHER|||||||0.0058||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0058
72543092|NCT00947765|144616491|SUPERIORITY_OR_OTHER|||||||0.0064||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0064
72543093|NCT05478603|144616505|OTHER||Ratio of adjusted geometric means|94.88|||||TWO_SIDED|90.0|70.86|127.04|||ANOVA||The ratio and 90% CI are expressed as percentages.|"One-way ANOVA was used on the natural log transformed PK parameters with hepatic function group as a fixed factor.~The adjusted mean differences and the corresponding 90% confidence intervals derived from ANOVA were exponentiated to provide estimate of the ratio of adjusted geometric means (Test \[hepatic impairment group\]/Reference \[without hepatic impairment group\]) and 90% confidence intervals for the ratio."||127.04|70.86|
72543094|NCT05478603|144616505|OTHER||Ratio of adjusted geometric means|99.75|||||TWO_SIDED|90.0|74.5|133.56|||ANOVA||The ratio and 90% CI are expressed as percentages.|"One-way ANOVA was used on the natural log transformed PK parameters with hepatic function group as a fixed factor.~The adjusted mean differences and the corresponding 90% confidence intervals derived from ANOVA were exponentiated to provide estimate of the ratio of adjusted geometric means (Test \[hepatic impairment group\]/Reference \[without hepatic impairment group\]) and 90% confidence intervals for the ratio."||133.56|74.50|
72543095|NCT05478603|144616505|OTHER||Ratio of adjusted geometric means|68.7|||||TWO_SIDED|90.0|51.31|91.98|||ANOVA||The ratio and 90% CI are expressed as percentages.|"One-way ANOVA was used on the natural log transformed PK parameters with hepatic function group as a fixed factor.~The adjusted mean differences and the corresponding 90% confidence intervals derived from ANOVA were exponentiated to provide estimate of the ratio of adjusted geometric means (Test \[hepatic impairment group\]/Reference \[without hepatic impairment group\]) and 90% confidence intervals for the ratio."||91.98|51.31|
72543096|NCT05478603|144616506|OTHER||Ratio of adjusted geometric means|101.87|||||TWO_SIDED|90.0|59.74|173.71|||ANOVA||The ratio and 90% CI are expressed as percentages.|"One-way ANOVA was used on the natural log transformed PK parameters with hepatic function group as a fixed factor.~The adjusted mean differences and the corresponding 90% confidence intervals derived from ANOVA were exponentiated to provide estimate of the ratio of adjusted geometric means (Test \[hepatic impairment group\]/Reference \[without hepatic impairment group\]) and 90% confidence intervals for the ratio."||173.71|59.74|
72543097|NCT05478603|144616506|OTHER||Ratio of adjusted geometric means|156.07|||||TWO_SIDED|90.0|91.53|266.14|||ANOVA||The ratio and 90% CI are expressed as percentages.|"One-way ANOVA was used on the natural log transformed PK parameters with hepatic function group as a fixed factor.~The adjusted mean differences and the corresponding 90% confidence intervals derived from ANOVA were exponentiated to provide estimate of the ratio of adjusted geometric means (Test \[hepatic impairment group\]/Reference \[without hepatic impairment group\]) and 90% confidence intervals for the ratio."||266.14|91.53|
72543098|NCT05478603|144616506|OTHER||Ratio of adjusted geometric means|96.48|||||TWO_SIDED|90.0|56.58|164.51|||ANOVA||The ratio and 90% CI are expressed as percentages.|"One-way ANOVA was used on the natural log transformed PK parameters with hepatic function group as a fixed factor.~The adjusted mean differences and the corresponding 90% confidence intervals derived from ANOVA were exponentiated to provide estimate of the ratio of adjusted geometric means (Test \[hepatic impairment group\]/Reference \[without hepatic impairment group\]) and 90% confidence intervals for the ratio."||164.51|56.58|
72543099|NCT05478603|144616507|OTHER||Ratio of adjusted geometric means|102.21|||||TWO_SIDED|90.0|59.91|174.39|||ANOVA||The ratio and 90% CI are expressed as percentages.|"One-way ANOVA was used on the natural log transformed PK parameters with hepatic function group as a fixed factor.~The adjusted mean differences and the corresponding 90% confidence intervals derived from ANOVA were exponentiated to provide estimate of the ratio of adjusted geometric means (Test \[hepatic impairment group\]/Reference \[without hepatic impairment group\]) and 90% confidence intervals for the ratio."||174.39|59.91|
72543100|NCT05478603|144616507|OTHER||Ratio of adjusted geometric means|152.91|||||TWO_SIDED|90.0|89.62|260.9|||ANOVA||The ratio and 90% CI are expressed as percentages.|"One-way ANOVA was used on the natural log transformed PK parameters with hepatic function group as a fixed factor.~The adjusted mean differences and the corresponding 90% confidence intervals derived from ANOVA were exponentiated to provide estimate of the ratio of adjusted geometric means (Test \[hepatic impairment group\]/Reference \[without hepatic impairment group\]) and 90% confidence intervals for the ratio."||260.90|89.62|
72543101|NCT05478603|144616507|OTHER||Ratio of adjusted geometric means|97.08|||||TWO_SIDED|90.0|56.9|165.65|||ANOVA||The ratio and 90% CI are expressed as percentages.|"One-way ANOVA was used on the natural log transformed PK parameters with hepatic function group as a fixed factor.~The adjusted mean differences and the corresponding 90% confidence intervals derived from ANOVA were exponentiated to provide estimate of the ratio of adjusted geometric means (Test \[hepatic impairment group\]/Reference \[without hepatic impairment group\]) and 90% confidence intervals for the ratio."||165.65|56.90|
72543102|NCT05478603|144616508|OTHER||Ratio of adjusted geometric means|93.29|||||TWO_SIDED|90.0|64.61|134.69|||ANOVA||The ratio and 90% CI are expressed as percentages.|"One-way ANOVA was used on the natural log transformed PK parameters with hepatic function group as a fixed factor.~The adjusted mean differences and the corresponding 90% confidence intervals derived from ANOVA were exponentiated to provide estimate of the ratio of adjusted geometric means (Test \[hepatic impairment group\]/Reference \[without hepatic impairment group\]) and 90% confidence intervals for the ratio."||134.69|64.61|
72543103|NCT05478603|144616508|OTHER||Ratio of adjusted geometric means|106.68|||||TWO_SIDED|90.0|73.89|154.03|||ANOVA||The ratio and 90% CI are expressed as percentages.|"One-way ANOVA was used on the natural log transformed PK parameters with hepatic function group as a fixed factor.~The adjusted mean differences and the corresponding 90% confidence intervals derived from ANOVA were exponentiated to provide estimate of the ratio of adjusted geometric means (Test \[hepatic impairment group\]/Reference \[without hepatic impairment group\]) and 90% confidence intervals for the ratio."||154.03|73.89|
72577658|NCT05013008|144682545|OTHER|The hypotheses 'H0i: βi=0' (i=1,…,27) were tested at a two-sided significance level of 5%, where βi was the estimator for the difference in log-transformed ratios of biomarker levels of Visit 11 to Visit 3 between finerenone and placebo group for the i-th of the 27 pre-specified biomarkers.|||||=|0.979||||||Benjamini-Hochberg adjusted P-value was calculated using the log2-scaled NPX value.|t-test, 2 sided|||The NPX difference (corresponding to log-transformed ratio to baseline) of C-C motif chemokine 16 (O15467) was analyzed.||||= 0.979
72577659|NCT05013008|144682545|OTHER|The hypotheses 'H0i: βi=0' (i=1,…,27) were tested at a two-sided significance level of 5%, where βi was the estimator for the difference in log-transformed ratios of biomarker levels of Visit 11 to Visit 3 between finerenone and placebo group for the i-th of the 27 pre-specified biomarkers.|||||=|0.979||||||Benjamini-Hochberg adjusted P-value was calculated using the log2-scaled NPX value.|t-test, 2 sided|||The NPX difference (corresponding to log-transformed ratio to baseline) of Collagen alpha-1(I) chain (P02452) was analyzed.||||= 0.979
72577660|NCT05013008|144682545|OTHER|The hypotheses 'H0i: βi=0' (i=1,…,27) were tested at a two-sided significance level of 5%, where βi was the estimator for the difference in log-transformed ratios of biomarker levels of Visit 11 to Visit 3 between finerenone and placebo group for the i-th of the 27 pre-specified biomarkers.|||||=|0.979||||||Benjamini-Hochberg adjusted P-value was calculated using the log2-scaled NPX value.|t-test, 2 sided|||The NPX difference (corresponding to log-transformed ratio to baseline) of Decorin (P07585) was analyzed.||||= 0.979
72410854|NCT04382326|144330107|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC was to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the IgG GMR of 20vPnC to 13vPnC for the serotype is greater than 0.5 (2-fold NI margin).|Geometric Mean Ratio|0.9|||||TWO_SIDED|95.0|0.81|1.0||||||Serotype 14: GMR and 2-Sided CI were calculated by exponentiating the mean difference (20vPnC-13vPnC) of the logarithms of the IgG concentrations and the corresponding CI (based on the Student's t distribution).||1.00|0.81|
72410855|NCT04382326|144330107|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC was to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the IgG GMR of 20vPnC to 13vPnC for the serotype is greater than 0.5 (2-fold NI margin).|Geometric Mean Ratio|0.74||||||95.0|0.67|0.82||||||Serotype 18C: GMR and 2-Sided CI were calculated by exponentiating the mean difference (20vPnC-13vPnC) of the logarithms of the IgG concentrations and the corresponding CI (based on the Student's t distribution).||0.82|0.67|
72410856|NCT04382326|144330107|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC was to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the IgG GMR of 20vPnC to 13vPnC for the serotype is greater than 0.5 (2-fold NI margin).|Geometric Mean Ratio|0.85|||||TWO_SIDED|95.0|0.77|0.94||||||Serotype 19A: GMR and 2-Sided CI were calculated by exponentiating the mean difference (20vPnC-13vPnC) of the logarithms of the IgG concentrations and the corresponding CI (based on the Student's t distribution).||0.94|0.77|
72410857|NCT04382326|144330107|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC was to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the IgG GMR of 20vPnC to 13vPnC for the serotype is greater than 0.5 (2-fold NI margin).|Geometric Mean Ratio|0.86|||||TWO_SIDED|95.0|0.78|0.96||||||Serotype 19F: GMR and 2-Sided CI were calculated by exponentiating the mean difference (20vPnC-13vPnC) of the logarithms of the IgG concentrations and the corresponding CI (based on the Student's t distribution).||0.96|0.78|
72410858|NCT04382326|144330107|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC was to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the IgG GMR of 20vPnC to 13vPnC for the serotype is greater than 0.5 (2-fold NI margin).|Geometric Mean Ratio|0.64|||||TWO_SIDED|95.0|0.57|0.72||||||Serotype 23F: GMR and 2-Sided CI were calculated by exponentiating the mean difference (20vPnC-13vPnC) of the logarithms of the IgG concentrations and the corresponding CI (based on the Student's t distribution).||0.72|0.57|
72410859|NCT04382326|144330107|NON_INFERIORITY|For the additional 7 serotypes, the compared results were from serotype 1 (13vPnC serotype with the lowest GMC, not including serotype 3) in the 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/lowest 13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|1.87|||||TWO_SIDED|95.0|1.71|2.06||||||Serotype 8: GMR and 2-Sided CI were calculated by exponentiating the mean difference (20vPnC - lowest 13vPnC) of the logarithms of the IgG concentrations and the corresponding CI (based on the Student's t distribution).||2.06|1.71|
72410860|NCT04382326|144330107|NON_INFERIORITY|For the additional 7 serotypes, the compared results were from serotype 1 (13vPnC serotype with the lowest GMC, not including serotype 3) in the 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/lowest 13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|2.94||||||95.0|2.64|3.26||||||Serotype 10A: GMR and 2-Sided CI were calculated by exponentiating the mean difference (20vPnC - lowest 13vPnC) of the logarithms of the IgG concentrations and the corresponding CI (based on the Student's t distribution).||3.26|2.64|
72410861|NCT04382326|144330107|NON_INFERIORITY|For the additional 7 serotypes, the compared results were from serotype 1 (13vPnC serotype with the lowest GMC, not including serotype 3) in the 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/lowest 13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|1.67|||||TWO_SIDED|95.0|1.51|1.84||||||Serotype 11A: GMR and 2-Sided CI were calculated by exponentiating the mean difference (20vPnC - lowest 13vPnC) of the logarithms of the IgG concentrations and the corresponding CI (based on the Student's t distribution).||1.84|1.51|
72577661|NCT05013008|144682545|OTHER|The hypotheses 'H0i: βi=0' (i=1,…,27) were tested at a two-sided significance level of 5%, where βi was the estimator for the difference in log-transformed ratios of biomarker levels of Visit 11 to Visit 3 between finerenone and placebo group for the i-th of the 27 pre-specified biomarkers.|||||=|0.979||||||Benjamini-Hochberg adjusted P-value was calculated using the log2-scaled NPX value.|t-test, 2 sided|||The NPX differences (corresponding to log-transformed ratio to baseline) of C-C motif chemokine 2 (P13500) was analyzed.||||= 0.979
72577662|NCT05013008|144682545|OTHER|The hypotheses 'H0i: βi=0' (i=1,…,27) were tested at a two-sided significance level of 5%, where βi was the estimator for the difference in log-transformed ratios of biomarker levels of Visit 11 to Visit 3 between finerenone and placebo group for the i-th of the 27 pre-specified biomarkers.|||||=|0.979||||||Benjamini-Hochberg adjusted P-value was calculated using the log2-scaled NPX value.|t-test, 2 sided|||The NPX difference (corresponding to log-transformed ratio to baseline) of Matrix metalloproteinase-9 (P14780) was analyzed.||||= 0.979
72577663|NCT05013008|144682545|OTHER|The hypotheses 'H0i: βi=0' (i=1,…,27) were tested at a two-sided significance level of 5%, where βi was the estimator for the difference in log-transformed ratios of biomarker levels of Visit 11 to Visit 3 between finerenone and placebo group for the i-th of the 27 pre-specified biomarkers.|||||=|0.979||||||Benjamini-Hochberg adjusted P-value was calculated using the log2-scaled NPX value.|t-test, 2 sided|||The NPX differences (corresponding to log-transformed ratio to baseline) of E-selectin (P16581) was analyzed.||||= 0.979
72629142|NCT06946888|144786450|OTHER|A generalized estimating equation (GEE) model included group (intervention group vs. control group), week (categorical: 0-8), group × week interaction, and age as covariates. Robust (sandwich) standard errors were used. Regression coefficients (B), standard errors, Wald chi-squared statistics, 95% confidence intervals, and p-values for group × week comparisons are reported.||||||0.913||||||This is the first week of tracking data. A P value \< 0.05 indicated a statistically significant difference.|Generalized Estimating Equations, GEE|Repeated-measures GEE was used to examine the group × time interaction between week 0 and week 1.||Generalized estimating equations (GEE) were chosen over repeated-measures analysis of variance or generalized linear mixed models because they provide estimates of the population mean, are robust to correlated error specifications, can accommodate missing data under the MAR/MCAR assumptions, and do not require sphericity. All tests were two-tailed, with α = 0.05.||||0.913
72410862|NCT04382326|144330107|NON_INFERIORITY|For the additional 7 serotypes, the compared results were from serotype 1 (13vPnC serotype with the lowest GMC, not including serotype 3) in the 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/lowest 13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|0.88||||||95.0|0.79|0.97||||||Serotype 12F: GMR and 2-Sided CI were calculated by exponentiating the mean difference (20vPnC - lowest 13vPnC) of the logarithms of the IgG concentrations and the corresponding CI (based on the Student's t distribution).||0.97|0.79|
72410863|NCT04382326|144330107|NON_INFERIORITY|For the additional 7 serotypes, the compared results were from serotype 1 (13vPnC serotype with the lowest GMC, not including serotype 3) in the 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/lowest 13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|5.95||||||95.0|5.39|6.55||||||Serotype 15B: GMR and 2-Sided CI were calculated by exponentiating the mean difference (20vPnC - lowest 13vPnC) of the logarithms of the IgG concentrations and the corresponding CI (based on the Student's t distribution).||6.55|5.39|
72410864|NCT04382326|144330107|NON_INFERIORITY|For the additional 7 serotypes, the compared results were from serotype 1 (13vPnC serotype with the lowest GMC, not including serotype 3) in the 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/lowest 13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|5.01||||||95.0|4.54|5.52||||||Serotype 22F: GMR and 2-Sided CI were calculated by exponentiating the mean difference (20vPnC - lowest 13vPnC) of the logarithms of the IgG concentrations and the corresponding CI (based on the Student's t distribution).||5.52|4.54|
72410865|NCT04382326|144330107|NON_INFERIORITY|For the additional 7 serotypes, the compared results were from serotype 1 (13vPnC serotype with the lowest GMC, not including serotype 3) in the 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/lowest 13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|4.4|||||TWO_SIDED|95.0|3.99|4.85||||||Serotype 33F: GMR and 2-Sided CI were calculated by exponentiating the mean difference (20vPnC - lowest 13vPnC) of the logarithms of the IgG concentrations and the corresponding CI (based on the Student's t distribution).||4.85|3.99|
72410866|NCT04382326|144330108|NON_INFERIORITY|Noninferiority was declared if the lower bound of the 2-sided 95% CI for the percentage differences (20vPnC - 13vPnC) was greater than -10%.|Percentage Difference|-4.3|||||TWO_SIDED|95.0|-7.5|-1.4||||||Diphtheria: 2-Sided CI was calculated using the Miettinen and Nurminen method for the difference in proportions, expressed as a percentage.||-1.4|-7.5|
72410867|NCT04382326|144330108|NON_INFERIORITY|Noninferiority was declared if the lower bound of the 2-sided 95% CI for the percentage differences (20vPnC - 13vPnC) was greater than -10%.|Percentage Difference|0.3|||||TWO_SIDED|95.0|-1.0|1.7||||||Tetanus: 2-Sided CI was calculated using the Miettinen and Nurminen method for the difference in proportions, expressed as a percentage.||1.7|-1.0|
72577664|NCT05013008|144682545|OTHER|The hypotheses 'H0i: βi=0' (i=1,…,27) were tested at a two-sided significance level of 5%, where βi was the estimator for the difference in log-transformed ratios of biomarker levels of Visit 11 to Visit 3 between finerenone and placebo group for the i-th of the 27 pre-specified biomarkers.|||||=|0.979||||||Benjamini-Hochberg adjusted P-value was calculated using the log2-scaled NPX value.|t-test, 2 sided|||The NPX difference (corresponding to log-transformed ratio to baseline) of Thrombospondin-2 (P35442) was analyzed.||||= 0.979
72577665|NCT05013008|144682545|OTHER|The hypotheses 'H0i: βi=0' (i=1,…,27) were tested at a two-sided significance level of 5%, where βi was the estimator for the difference in log-transformed ratios of biomarker levels of Visit 11 to Visit 3 between finerenone and placebo group for the i-th of the 27 pre-specified biomarkers.|||||=|0.979||||||Benjamini-Hochberg adjusted P-value was calculated using the log2-scaled NPX value.|t-test, 2 sided|||The NPX difference (corresponding to log-transformed ratio to baseline) of RARRES2 (Q99969) was analyzed.||||= 0.979
72577666|NCT05013008|144682545|OTHER|The hypotheses 'H0i: βi=0' (i=1,…,27) were tested at a two-sided significance level of 5%, where βi was the estimator for the difference in log-transformed ratios of biomarker levels of Visit 11 to Visit 3 between finerenone and placebo group for the i-th of the 27 pre-specified biomarkers.|||||=|0.979||||||Benjamini-Hochberg adjusted P-value was calculated using the log2-scaled NPX value.|t-test, 2 sided|||The NPX difference (corresponding to log-transformed ratio to baseline) of C-X-C motif chemokine 16 (Q9H2A7) was analyzed.||||= 0.979
72577667|NCT05013008|144682545|OTHER|The hypotheses 'H0i: βi=0' (i=1,…,27) were tested at a two-sided significance level of 5%, where βi was the estimator for the difference in log-transformed ratios of biomarker levels of Visit 11 to Visit 3 between finerenone and placebo group for the i-th of the 27 pre-specified biomarkers.|||||=|0.979||||||Benjamini-Hochberg adjusted P-value was calculated using the log2-scaled NPX value.|t-test, 2 sided|||The NPX difference (corresponding to log-transformed ratio to baseline) of Dickkopf-related protein 3 (Q9UBP4) was analyzed.||||= 0.979
72421518|NCT01342458|144354200|SUPERIORITY_OR_OTHER||Effect size|1.45|||<|0.001|TWO_SIDED||||||post hoc Newman-Keuls|||From baseline to 3rd month.||||<0.001
72577668|NCT02111603|144682555|SUPERIORITY_OR_OTHER|||||||0.012|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Comparison of on-treatment total fecal bile acid excretion with baseline total fecal bile acid excretion.||||0.012
72577669|NCT03106987|144682561|OTHER||Hazard Ratio (HR)|0.566||||0.022|TWO_SIDED|95.0|0.372|0.868|||Stratified log-rank||Hazard Ratio (Cox Proportional Hazards model)|||0.868|0.372|0.0220
72577670|NCT03106987|144682561|OTHER||Hazard Ratio (HR)|0.43||||0.0023|TWO_SIDED|95.0|0.264|0.708|||Stratified log-rank||Hazard Ratio (Cox Proportional Hazards model)|||0.708|0.264|0.0023
72577671|NCT02114385|144682572|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority required that the lower bound of the two-sided confidence interval (CI) of the GMT ratio was \>0.50|GMT Ratio|1.23|||<|0.001|TWO_SIDED|95.0|1.04|1.45|||ANOVA||GMT ratio = GMT (V503) / GMT (Gardasil)|HPV Type 6||1.45|1.04|<0.001
72577672|NCT02114385|144682572|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority required that the lower bound of the two-sided confidence interval (CI) of the GMT ratio was \>0.50|GMT Ratio|0.89|||<|0.001|TWO_SIDED|95.0|0.76|1.04|||ANOVA||GMT ratio = GMT (V503) / GMT (Gardasil)|HPV Type 11||1.04|0.76|<0.001
72329449|NCT03037476|144184382|OTHER|General Linear Model|Slope|-0.1||||0.524|TWO_SIDED|95.0|-0.408|0.208|||Mixed Models Analysis|Poisson Regression||Change in Past 3 Month Tobacco Use from Baseline to 12 Month Followup||.208|-.408|.524
72577673|NCT02114385|144682572|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority required that the lower bound of the two-sided confidence interval (CI) of the GMT ratio was \>0.50|GMT Ratio|1.04|||<|0.001|TWO_SIDED|95.0|0.89|1.21|||ANOVA||GMT ratio = GMT (V503) / GMT (Gardasil)|HPV Type 16||1.21|0.89|<0.001
72410868|NCT04382326|144330108|NON_INFERIORITY|Noninferiority was declared if the lower bound of the 2-sided 95% CI for the percentage differences (20vPnC - 13vPnC) was greater than -10%.|Percentage Difference|-0.2||||||95.0|-3.5|3.1||||||Pertussis (PT): 2-Sided CI was calculated using the Miettinen and Nurminen method for the difference in proportions, expressed as a percentage.||3.1|-3.5|
72410869|NCT04382326|144330108|NON_INFERIORITY|Noninferiority was declared if the lower bound of the 2-sided 95% CI for the percentage differences (20vPnC - 13vPnC) was greater than -10%.|Percentage Difference|0.6||||||95.0|-2.5|3.9||||||Pertussis (FHA): 2-Sided CI was calculated using the Miettinen and Nurminen method for the difference in proportions, expressed as a percentage.||3.9|-2.5|
72577674|NCT02114385|144682572|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority required that the lower bound of the two-sided confidence interval (CI) of the GMT ratio was \>0.50|GMT Ratio|1.12|||<|0.001|TWO_SIDED|95.0|0.91|1.37|||ANOVA||GMT ratio = GMT (V503) / GMT (Gardasil)|HPV Type 18||1.37|0.91|<0.001
72577675|NCT02995408|144682633|SUPERIORITY||Mean Difference (Final Values)|-0.99||||0.23|TWO_SIDED|95.0|-2.63|0.65||p-value was calculated|t-test, 2 sided|||||0.65|-2.63|.23
72577676|NCT02995408|144682634|SUPERIORITY||Mean Difference (Final Values)|5.78||||0.024|TWO_SIDED|95.0|0.78|10.78||.05 is the threshold for significance|t-test, 2 sided|||We examined between group (3RP treatment versus wait-list) differences in pre-post change scores of resiliency.||10.78|.78|0.024
72577677|NCT02995408|144682635|SUPERIORITY||Mean Difference (Final Values)|7.78||||0.001|TWO_SIDED|95.0|3.45|12.12||p=.05 is the threshold for significance.|t-test, 2 sided|||||12.12|3.45|0.001
72577678|NCT00295061|144682636|NON_INFERIORITY_OR_EQUIVALENCE|A total sample size of 20 subjects could demonstrate comparability of an AUC(0-7days) with 90% power up to a standard deviation of 0.288 of the difference in the log scale, expected mean treatment difference of 0 (= ratio of 1), a lower equivalence limit of -0.223 (= log 0.8), upper limit of 0.223 (= log 1.25) and a one-sided alpha of 0.05 (90% CI).|Geometric least square means ratio|1.03||||||90.0|0.97|1.09||||||To compare AUC 0-7 days between the two treatments (Alpha-1 MP vs. Prolastin),natural log-transformed AUC 0-7 days values were analyzed by analysis of variance (ANOVA).||1.09|0.97|
72577679|NCT00704132|144682640|SUPERIORITY_OR_OTHER||Difference in Least-Squares Mean|-111.0|||<|0.001||95.0|-158.0|-63.9|||ANCOVA||Sitagliptin minus Placebo|||-63.9|-158.0|<0.001
72577680|NCT03633825|144682652|SUPERIORITY||Risk Ratio (RR)|1.23|||=|0.02|TWO_SIDED|95.0|1.03|1.46|||Chi-squared|||||1.46|1.03|=.02
72577681|NCT03633825|144682653|SUPERIORITY||Risk Ratio (RR)|1.2|||=|0.19|TWO_SIDED|95.0|0.91|1.59|||Chi-squared|||||1.59|0.91|=.19
72577682|NCT05199090|144682680|OTHER||adjusted means|-1.9||||0.0182|TWO_SIDED|80.0|-2.9|-0.9|||MMRM analysis|||Comparison of adjusted means||-0.9|-2.9|0.0182
72577683|NCT05199090|144682680|OTHER||adjusted means|-1.3||||0.1205|TWO_SIDED|80.0|-2.4|-0.2|||MMRM analysis|||||-0.2|-2.4|0.1205
72577684|NCT05199090|144682680|OTHER||adjusted means|-1.3||||0.0931|TWO_SIDED|80.0|-2.2|-0.3|||MMRM analysis|||||-0.3|-2.2|0.0931
72577685|NCT05199090|144682680|OTHER||adjusted means|0.6||||0.4994|TWO_SIDED|80.0|-0.5|1.7|||MMRM analysis|||||1.7|-0.5|0.4994
72577686|NCT05199090|144682680|OTHER||adjusted means|1.0||||0.2295|TWO_SIDED|80.0|-0.1|2.1|||MMRM analysis|||||2.1|-0.1|0.2295
72577687|NCT05199090|144682680|OTHER||adjusted means|-0.7||||0.2114|TWO_SIDED|80.0|-1.3|0.0|||MMRM analysis|||||0.0|-1.3|0.2114
72577688|NCT02027428|144682685|SUPERIORITY||Hazard Ratio (HR)|0.85||||0.3486|TWO_SIDED|95.0|0.61|1.19||Stratification factors evaluated in the sparse strata elimination algorithm: stage of disease (IIIB or IV) at diagnosis, ECOG performance status (0 or 1) at end of Induction, and tumor response (CR/PR or SD) at end of Induction.|stratified log-rank test||Hazard ratio: nab-paclitaxel + BSC / BSC Alone|5% level of significance. Hazard ratio is based on stratified Cox proportional hazards regression model. The following stratification factors were evaluated in the sparse strata elimination algorithm: stage of disease (IIIB or IV) at diagnosis, ECOG performance status (0 or 1) at end of Induction, and tumor response (CR/PR or SD) at the end of Induction.||1.19|0.61|0.3486
72329450|NCT03037476|144184382|OTHER|General Linear Model|Slope|0.008||||0.913|TWO_SIDED|95.0|-0.137|0.153|||Mixed Models Analysis|Poisson Regression||Change in Past 3 Month Alcohol Use from Baseline to 6 Month Followup||.153|-.137|.913
72577689|NCT02027428|144682686|SUPERIORITY||Hazard Ratio (HR)|0.68||||0.0365|TWO_SIDED|95.0|0.47|0.98||Stratification factors evaluated in the sparse strata elimination algorithm: stage of disease (IIIB or IV) at diagnosis, ECOG performance status (0 or 1) at end of Induction, and tumor response (CR/PR or SD) at end of Induction.|stratified log-rank test||Hazard ratio: nab-paclitaxel + BSC / BSC Alone|5% level of significance. Hazard ratio is based on stratified Cox proportional hazards regression model. The following stratification factors were evaluated in the sparse strata elimination algorithm: stage of disease (IIIB or IV) at diagnosis, ECOG performance status (0 or 1) at end of Induction, and tumor response (CR/PR or SD) at the end of Induction.||0.98|0.47|0.0365
72577690|NCT02027428|144682687|SUPERIORITY||Overall response rate ratio|1.2||||0.087|TWO_SIDED|95.0|0.948|1.519||Stratification factors evaluated in the sparse strata elimination algorithm: stage of disease (IIIB or IV) at diagnosis, ECOG performance status (0 or 1) at the end of Induction, and tumor response (CR/PR or SD) at the end of Induction.|Cochran-Mantel-Haenszel||response ratio: nab-paclitaxel + BSC / BSC Alone|5% level of significance. The rate ratio and its 95% CI were based on the non-stratified analysis.||1.519|0.948|0.0870
72577691|NCT02027428|144682688|SUPERIORITY||Hazard Ratio (HR)|0.87||||0.4164|TWO_SIDED|95.0|0.62|1.22||Stratification factors evaluated in the sparse strata elimination algorithm: stage of disease (IIIB or IV) at diagnosis, ECOG performance status (0 or 1) at end of Induction, and tumor response (CR/PR or SD) at end of Induction.|stratified log-rank test||Hazard ratio: nab-paclitaxel + BSC / BSC Alone|5% level of significance. Hazard ratio is based on stratified Cox proportional hazards regression model. The following stratification factors were evaluated in the sparse strata elimination algorithm: stage of disease (IIIB or IV) at diagnosis, ECOG performance status (0 or 1) at end of Induction, and tumor response (CR/PR or SD) at the end of Induction.||1.22|0.62|0.4164
72629143|NCT06946888|144786450|OTHER|A generalized estimating equation (GEE) model included group (intervention group vs. control group), week (categorical: 0-8), group × week interaction, and age as covariates. Robust (sandwich) standard errors were used. Regression coefficients (B), standard errors, Wald chi-squared statistics, 95% confidence intervals, and p-values for group × week comparisons are reported.||||||0.802||||||This is the second week of tracking data. A P value \< 0.05 indicated a statistically significant difference.|Generalized Estimating Equations, GEE|Repeated-measures GEE was used to examine the group × time interaction between week 0 and week 2.||Generalized estimating equations (GEE) were chosen over repeated-measures analysis of variance or generalized linear mixed models because they provide estimates of the population mean, are robust to correlated error specifications, can accommodate missing data under the MAR/MCAR assumptions, and do not require sphericity. All tests were two-tailed, with α = 0.05.||||0.802
72629144|NCT06946888|144786450|OTHER|A generalized estimating equation (GEE) model included group (intervention group vs. control group), week (categorical: 0-8), group × week interaction, and age as covariates. Robust (sandwich) standard errors were used. Regression coefficients (B), standard errors, Wald chi-squared statistics, 95% confidence intervals, and p-values for group × week comparisons are reported.||||||0.605||||||This is the third week of tracking data. A P value \< 0.05 indicated a statistically significant difference.|Generalized Estimating Equations, GEE|Repeated-measures GEE was used to examine the group × time interaction between week 0 and week 3.||Generalized estimating equations (GEE) were chosen over repeated-measures analysis of variance or generalized linear mixed models because they provide estimates of the population mean, are robust to correlated error specifications, can accommodate missing data under the MAR/MCAR assumptions, and do not require sphericity. All tests were two-tailed, with α = 0.05.||||0.605
72629145|NCT06946888|144786450|OTHER|A generalized estimating equation (GEE) model included group (intervention group vs. control group), week (categorical: 0-8), group × week interaction, and age as covariates. Robust (sandwich) standard errors were used. Regression coefficients (B), standard errors, Wald chi-squared statistics, 95% confidence intervals, and p-values for group × week comparisons are reported.||||||0.35||||||This is the fourth week of tracking data. A P value \< 0.05 indicated a statistically significant difference.|Generalized Estimating Equations, GEE|Repeated-measures GEE was used to examine the group × time interaction between week 0 and week 4.||Generalized Estimating Equations were used to analyze repeated measures data and to assess the interaction effect between group and time. Potential interfering factors such as age and years of work experience were controlled during the analysis, and the effect size (Cohen's d) and its 95% confidence interval were calculated to assist in interpreting the clinical significance. Statistical analysis was performed using SPSS version XX or R version XX, and the significance level was set at p \< 0.05.||||0.350
72629146|NCT06946888|144786450|OTHER|A generalized estimating equation (GEE) model included group (intervention group vs. control group), week (categorical: 0-8), group × week interaction, and age as covariates. Robust (sandwich) standard errors were used. Regression coefficients (B), standard errors, Wald chi-squared statistics, 95% confidence intervals, and p-values for group × week comparisons are reported.||||||1||||||This is the fifth week of tracking data. A P value \< 0.05 indicated a statistically significant difference.|Generalized Estimating Equations, GEE|Repeated-measures GEE was used to examine the group × time interaction between week 0 and week 5.||Generalized estimating equations (GEE) were chosen over repeated-measures analysis of variance or generalized linear mixed models because they provide estimates of the population mean, are robust to correlated error specifications, can accommodate missing data under the MAR/MCAR assumptions, and do not require sphericity. All tests were two-tailed, with α = 0.05.||||1.000
72629147|NCT06946888|144786450|OTHER|A generalized estimating equation (GEE) model included group (intervention group vs. control group), week (categorical: 0-8), group × week interaction, and age as covariates. Robust (sandwich) standard errors were used. Regression coefficients (B), standard errors, Wald chi-squared statistics, 95% confidence intervals, and p-values for group × week comparisons are reported.||||||0.744||||||This is the sixth week of tracking data. A P value \< 0.05 indicated a statistically significant difference.|Generalized Estimating Equations, GEE|Repeated-measures GEE was used to examine the group × time interaction between week 0 and week 6.||Generalized estimating equations (GEE) were chosen over repeated-measures analysis of variance or generalized linear mixed models because they provide estimates of the population mean, are robust to correlated error specifications, can accommodate missing data under the MAR/MCAR assumptions, and do not require sphericity. All tests were two-tailed, with α = 0.05.||||0.744
72629148|NCT06946888|144786450|OTHER|A generalized estimating equation (GEE) model included group (intervention group vs. control group), week (categorical: 0-8), group × week interaction, and age as covariates. Robust (sandwich) standard errors were used. Regression coefficients (B), standard errors, Wald chi-squared statistics, 95% confidence intervals, and p-values for group × week comparisons are reported.||||||0.202||||||This is the seventh week of tracking data. A P value \< 0.05 indicated a statistically significant difference.|Generalized Estimating Equations, GEE|Repeated-measures GEE was used to examine the group × time interaction between week 0 and week 7.||Generalized estimating equations (GEE) were chosen over repeated-measures analysis of variance or generalized linear mixed models because they provide estimates of the population mean, are robust to correlated error specifications, can accommodate missing data under the MAR/MCAR assumptions, and do not require sphericity. All tests were two-tailed, with α = 0.05.||||0.202
72629149|NCT06946888|144786450|OTHER|A generalized estimating equation (GEE) model included group (intervention group vs. control group), week (categorical: 0-8), group × week interaction, and age as covariates. Robust (sandwich) standard errors were used. Regression coefficients (B), standard errors, Wald chi-squared statistics, 95% confidence intervals, and p-values for group × week comparisons are reported.||||||0.918||||||This is the eighth week of tracking data. A P value \< 0.05 indicated a statistically significant difference.|Generalized Estimating Equations, GEE|Repeated-measures GEE was used to examine the group × time interaction between week 0 and week 8.||Generalized estimating equations (GEE) were chosen over repeated-measures analysis of variance or generalized linear mixed models because they provide estimates of the population mean, are robust to correlated error specifications, can accommodate missing data under the MAR/MCAR assumptions, and do not require sphericity. All tests were two-tailed, with α = 0.05.||||0.918
72421519|NCT01342458|144354200|SUPERIORITY_OR_OTHER||Effect size|1.69||||0.019|TWO_SIDED||||||post hoc Newman-Keuls|||From baseline to 6th month.||||0.019
72421520|NCT01342458|144354200|SUPERIORITY_OR_OTHER||Effect size|0.66|||<|0.001|TWO_SIDED||||||post hoc Newman-Keuls|||From baseline to 3rd month.||||<0.001
72329451|NCT03037476|144184382|OTHER|General Linear Model|Slope|0.032||||0.676|TWO_SIDED|95.0|-0.117|0.181|||Mixed Models Analysis|Poisson Regresision||Change in Past 3 Month Alcohol Use from Baseline to 12 Month Followup||.181|-.117|.676
72421521|NCT01342458|144354200|SUPERIORITY_OR_OTHER||Effect size|0.44|||<|0.001|TWO_SIDED||||||post hoc Newman-Keuls|||From baseline to 6th month.||||<0.001
72329452|NCT03037476|144184382|OTHER|General Linear Model|Slope|-0.035||||0.712|TWO_SIDED|95.0|-0.223|0.152|||Mixed Models Analysis|Poisson Regression||Change in Past 3 Month Marijuana Use from Baseline to 6 Month Followup||.152|-.223|.712
72577692|NCT02027428|144682689|SUPERIORITY||Hazard Ratio (HR)|0.68||||0.0381|TWO_SIDED|95.0|0.47|0.98||Stratification factors evaluated in the sparse strata elimination algorithm: stage of disease (IIIB or IV) at diagnosis, ECOG performance status (0 or 1) at end of Induction, and tumor response (CR/PR or SD) at end of Induction.|stratified log-rank test||Hazard ratio: nab-paclitaxel + BSC / BSC Alone|5% level of significance. Hazard ratio is based on stratified Cox proportional hazards regression model. The following stratification factors were evaluated in the sparse strata elimination algorithm: stage of disease (IIIB or IV) at diagnosis, ECOG performance status (0 or 1) at end of Induction, and tumor response (CR/PR or SD) at the end of Induction.||0.98|0.47|0.0381
72577693|NCT02027428|144682690|SUPERIORITY||Overall response rate ratio|3.15||||0.0978|TWO_SIDED|95.0|0.733|13.574||5% level of significance.|Cochran-Mantel-Haenszel||Response rate ratio: nab-paclitaxel + BSC / BSC Alone|||13.574|0.733|0.0978
72577694|NCT02027428|144682691|SUPERIORITY||disease control rate ratio|0.99|||||TWO_SIDED|95.0|0.978|1.007|||||Disease control rate ratio: nab-paclitaxel + BSC / BSC Alone|The rate ratio and its 95% confidence interval are based on non-stratified analysis.||1.007|0.978|
72577695|NCT02027428|144682693|SUPERIORITY||Hazard Ratio (HR)|0.93|||||TWO_SIDED|95.0|0.59|1.47|||||Hazard ratio: nab-paclitaxel + BSC / BSC Alone|Hazard ratio was based on stratified Cox proportional hazards regression model. The following stratification factors were evaluated in the sparse strata elimination algorithm: stage of disease (IIIB or IV) at diagnosis, ECOG performance status (0 or 1) at the end of Induction, and tumor response (CR/PR or SD) at the end of Induction.||1.47|0.59|
72577696|NCT04784533|144682702|SUPERIORITY||Difference in percentages|16.2|||||TWO_SIDED|95.0|5.5|26.8|||||Treatment difference is calculated as the difference between the percentage of responders in the 12 mg BID group versus the 8 mg BID group.|Week 12||26.8|5.5|
72577697|NCT04784533|144682702|SUPERIORITY||Difference in percentages|12.1|||||TWO_SIDED|95.0|1.3|22.9|||||Treatment difference is calculated as the difference between the percentage of responders in the 12 mg BID group versus the 8 mg BID group.|Week 16||22.9|1.3|
72577698|NCT04784533|144682702|SUPERIORITY||Difference in percentages|26.4|||||TWO_SIDED|95.0|15.4|37.5|||||Treatment difference is calculated as the difference between the percentage of responders in the 12 mg BID group versus the 8 mg BID group.|Week 20||37.5|15.4|
72577699|NCT04784533|144682702|SUPERIORITY||Difference in percentages|19.9|||||TWO_SIDED|95.0|8.5|31.3|||||Treatment difference is calculated as the difference between the percentage of responders in the 12 mg BID group versus the 8 mg BID group.|Week 24||31.3|8.5|
72577700|NCT04784533|144682703|SUPERIORITY||Difference in percentages|0.6|||||TWO_SIDED|95.0|-2.7|3.9|||||Treatment difference is calculated as the difference between the percentage of responders in the 12 mg BID group versus the 8 mg BID group.|Week 8||3.9|-2.7|
72577701|NCT04784533|144682703|SUPERIORITY||Difference in percentages|10.6|||||TWO_SIDED|95.0|3.3|17.9|||||Treatment difference is calculated as the difference between the percentage of responders in the 12 mg BID group versus the 8 mg BID group.|Week 12||17.9|3.3|
72577702|NCT04784533|144682703|SUPERIORITY||Difference in percentages|14.0|||||TWO_SIDED|95.0|5.3|22.8|||||Treatment difference is calculated as the difference between the percentage of responders in the 12 mg BID group versus the 8 mg BID group.|Week 16||22.8|5.3|
72577703|NCT04784533|144682703|SUPERIORITY||Difference in percentages|19.4|||||TWO_SIDED|95.0|9.2|29.5|||||Treatment difference is calculated as the difference between the percentage of responders in the 12 mg BID group versus the 8 mg BID group.|Week 20||29.5|9.2|
72577704|NCT04784533|144682703|SUPERIORITY||Difference in percentages|20.8|||||TWO_SIDED|95.0|9.8|31.7|||||Treatment difference is calculated as the difference between the percentage of responders in the 12 mg BID group versus the 8 mg BID group.|Week 24||31.7|9.8|
72577705|NCT04784533|144682704|SUPERIORITY||Least Square (LS) Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|1.18|||TWO_SIDED|95.0|-2.8|1.8|||||LS means,standard error(SE),and confidence intervals(CIs) are based on mixed model repeated measures(MMRM)analysis with effects for treatment,visit,treatment-by-visit interaction,and baseline value.The Model uses an unstructured covariance structure.|Week 4||1.8|-2.8|
72577706|NCT04784533|144682704|SUPERIORITY||LS Mean Difference|-7.3|STANDARD_ERROR_OF_MEAN|2.32|||TWO_SIDED|95.0|-11.9|-2.7|||||LS means, SE, and CIs are based on an MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value. The model is fit using an unstructured covariance structure.|Week 8||-2.7|-11.9|
72577707|NCT04784533|144682704|SUPERIORITY||LS Mean Difference|-12.4|STANDARD_ERROR_OF_MEAN|3.5|||TWO_SIDED|95.0|-19.3|-5.5|||||LS means, SE, and CIs are based on an MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value. The model is fit using an unstructured covariance structure.|Week 12||-5.5|-19.3|
72577708|NCT04784533|144682704|SUPERIORITY||LS Mean Difference|-14.6|STANDARD_ERROR_OF_MEAN|3.9|||TWO_SIDED|95.0|-22.2|-6.9|||||LS means, SE, and CIs are based on an MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value. The model is fit using an unstructured covariance structure.|Week 16||-6.9|-22.2|
72577709|NCT04784533|144682704|SUPERIORITY||LS Mean Difference|-15.4|STANDARD_ERROR_OF_MEAN|4.2|||TWO_SIDED|95.0|-23.7|-7.2|||||LS means, SE, and CIs are based on an MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value. The model is fit using an unstructured covariance structure.|Week 20||-7.2|-23.7|
72577710|NCT04784533|144682704|SUPERIORITY||LS Mean Difference|-15.4|STANDARD_ERROR_OF_MEAN|4.36|||TWO_SIDED|95.0|-24.0|-6.8|||||LS means, SE, and CIs are based on an MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value. The model is fit using an unstructured covariance structure.|Week 24||-6.8|-24.0|
72577711|NCT04784533|144682705|SUPERIORITY||Difference in percentages|20.9|||||TWO_SIDED|95.0|9.9|31.8|||||Treatment difference is calculated as the difference between the percentage of responders in the 12 mg BID group versus the 8 mg BID group.|Week 12||31.8|9.9|
72543104|NCT05478603|144616508|OTHER||Ratio of adjusted geometric means|246.28|||||TWO_SIDED|90.0|170.57|355.58|||ANOVA||The ratio and 90% CI are expressed as percentages.|"One-way ANOVA was used on the natural log transformed PK parameters with hepatic function group as a fixed factor.~The adjusted mean differences and the corresponding 90% confidence intervals derived from ANOVA were exponentiated to provide estimate of the ratio of adjusted geometric means (Test \[hepatic impairment group\]/Reference \[without hepatic impairment group\]) and 90% confidence intervals for the ratio."||355.58|170.57|
72543105|NCT05478603|144616509|OTHER||Ratio of adjusted geometric means|88.5|||||TWO_SIDED|90.0|64.13|122.12|||ANOVA||The ratio and 90% CI are expressed as percentages.|"One-way ANOVA was used on the natural log transformed PK parameters with hepatic function group as a fixed factor.~The adjusted mean differences and the corresponding 90% confidence intervals derived from ANOVA were exponentiated to provide estimate of the ratio of adjusted geometric means (Test \[hepatic impairment group\]/Reference \[without hepatic impairment group\]) and 90% confidence intervals for the ratio."||122.12|64.13|
72543106|NCT05478603|144616509|OTHER||Ratio of adjusted geometric means|106.4|||||TWO_SIDED|90.0|77.11|146.83|||ANOVA||The ratio and 90% CI are expressed as percentages.|"One-way ANOVA was used on the natural log transformed PK parameters with hepatic function group as a fixed factor.~The adjusted mean differences and the corresponding 90% confidence intervals derived from ANOVA were exponentiated to provide estimate of the ratio of adjusted geometric means (Test \[hepatic impairment group\]/Reference \[without hepatic impairment group\]) and 90% confidence intervals for the ratio."||146.83|77.11|
72543107|NCT05478603|144616509|OTHER||Ratio of adjusted geometric means|169.19|||||TWO_SIDED|90.0|122.61|233.47|||ANOVA||The ratio and 90% CI are expressed as percentages.|"One-way ANOVA was used on the natural log transformed PK parameters with hepatic function group as a fixed factor.~The adjusted mean differences and the corresponding 90% confidence intervals derived from ANOVA were exponentiated to provide estimate of the ratio of adjusted geometric means (Test \[hepatic impairment group\]/Reference \[without hepatic impairment group\]) and 90% confidence intervals for the ratio."||233.47|122.61|
72543108|NCT05478603|144616510|OTHER||Ratio of adjusted geometric means|95.12|||||TWO_SIDED|90.0|52.6|172.03|||ANOVA||The ratio and 90% CI are expressed as percentages.|"One-way ANOVA was used on the natural log transformed PK parameters with hepatic function group as a fixed factor.~The adjusted mean differences and the corresponding 90% confidence intervals derived from ANOVA were exponentiated to provide estimate of the ratio of adjusted geometric means (Test \[hepatic impairment group\]/Reference \[without hepatic impairment group\]) and 90% confidence intervals for the ratio."||172.03|52.60|
72543109|NCT05478603|144616510|OTHER||Ratio of adjusted geometric means|166.77|||||TWO_SIDED|90.0|92.21|301.62|||ANOVA||The ratio and 90% CI are expressed as percentages.|"One-way ANOVA was used on the natural log transformed PK parameters with hepatic function group as a fixed factor.~The adjusted mean differences and the corresponding 90% confidence intervals derived from ANOVA were exponentiated to provide estimate of the ratio of adjusted geometric means (Test \[hepatic impairment group\]/Reference \[without hepatic impairment group\]) and 90% confidence intervals for the ratio."||301.62|92.21|
72543110|NCT05478603|144616510|OTHER||Ratio of adjusted geometric means|237.76|||||TWO_SIDED|90.0|131.46|430.0|||ANOVA||The ratio and 90% CI are expressed as percentages.|"One-way ANOVA was used on the natural log transformed PK parameters with hepatic function group as a fixed factor.~The adjusted mean differences and the corresponding 90% confidence intervals derived from ANOVA were exponentiated to provide estimate of the ratio of adjusted geometric means (Test \[hepatic impairment group\]/Reference \[without hepatic impairment group\]) and 90% confidence intervals for the ratio."||430.00|131.46|
72543111|NCT05478603|144616511|OTHER||Ratio of adjusted geometric means|95.34|||||TWO_SIDED|90.0|52.67|172.59|||ANOVA||The ratio and 90% CI are expressed as percentages.|"One-way ANOVA was used on the natural log transformed PK parameters with hepatic function group as a fixed factor.~The adjusted mean differences and the corresponding 90% confidence intervals derived from ANOVA were exponentiated to provide estimate of the ratio of adjusted geometric means (Test \[hepatic impairment group\]/Reference \[without hepatic impairment group\]) and 90% confidence intervals for the ratio."||172.59|52.67|
72543112|NCT05478603|144616511|OTHER||Ratio of adjusted geometric means|163.09|||||TWO_SIDED|90.0|90.1|295.22|||ANOVA||The ratio and 90% CI are expressed as percentages.|"One-way ANOVA was used on the natural log transformed PK parameters with hepatic function group as a fixed factor.~The adjusted mean differences and the corresponding 90% confidence intervals derived from ANOVA were exponentiated to provide estimate of the ratio of adjusted geometric means (Test \[hepatic impairment group\]/Reference \[without hepatic impairment group\]) and 90% confidence intervals for the ratio."||295.22|90.10|
72543113|NCT05478603|144616511|OTHER||Ratio of adjusted geometric means|239.47|||||TWO_SIDED|90.0|132.29|433.47|||ANOVA||The ratio and 90% CI are expressed as percentages.|"One-way ANOVA was used on the natural log transformed PK parameters with hepatic function group as a fixed factor.~The adjusted mean differences and the corresponding 90% confidence intervals derived from ANOVA were exponentiated to provide estimate of the ratio of adjusted geometric means (Test \[hepatic impairment group\]/Reference \[without hepatic impairment group\]) and 90% confidence intervals for the ratio."||433.47|132.29|
72577712|NCT04784533|144682705|SUPERIORITY||Difference in percentages|13.8|||||TWO_SIDED|95.0|2.5|25.2|||||Treatment difference is calculated as the difference between the percentage of responders in the 12 mg BID group versus the 8 mg BID group.|Week 16||25.2|2.5|
72577713|NCT04784533|144682705|SUPERIORITY||Difference in percentages|15.6|||||TWO_SIDED|95.0|4.1|27.0|||||Treatment difference is calculated as the difference between the percentage of responders in the 12 mg BID group versus the 8 mg BID group.|Week 20||27.0|4.1|
72577714|NCT04784533|144682705|SUPERIORITY||Difference in percentages|14.4|||||TWO_SIDED|95.0|2.9|25.9|||||Treatment difference is calculated as the difference between the percentage of responders in the 12 mg BID group versus the 8 mg BID group.|Week 24||25.9|2.9|
72577715|NCT04784533|144682706|SUPERIORITY||Difference in percentages|22.9|||||TWO_SIDED|95.0|11.9|34.0|||||Treatment difference is calculated as the difference between the percentage of responders in the 12 mg BID group versus the 8 mg BID group.|Week 12||34.0|11.9|
72577716|NCT04784533|144682706|SUPERIORITY||Difference in percentages|21.9|||||TWO_SIDED|95.0|10.7|33.1|||||Treatment difference is calculated as the difference between the percentage of responders in the 12 mg BID group versus the 8 mg BID group.|Week 16||33.1|10.7|
72577717|NCT04784533|144682706|SUPERIORITY||Difference in percentages|22.6|||||TWO_SIDED|95.0|11.2|33.9|||||Treatment difference is calculated as the difference between the percentage of responders in the 12 mg BID group versus the 8 mg BID group.|Week 20||33.9|11.2|
72410870|NCT04382326|144330108|NON_INFERIORITY|Noninferiority was declared if the lower bound of the 2-sided 95% CI for the percentage differences (20vPnC - 13vPnC) was greater than -10%.|Percentage Difference|-1.3||||||95.0|-4.7|2.2||||||Pertussis (PRN): 2-Sided CI was calculated using the Miettinen and Nurminen method for the difference in proportions, expressed as a percentage.2-Sided CIs are calculated using the Miettinen and Nurminen method for the difference in proportions, expressed as a percentage.||2.2|-4.7|
72410871|NCT04382326|144330108|NON_INFERIORITY|Noninferiority was declared if the lower bound of the 2-sided 95% CI for the percentage differences (20vPnC - 13vPnC) was greater than -10%.|Percentage Difference|0.0||||||95.0|-3.2|2.9||||||HBsAg: 2-Sided CI was calculated using the Miettinen and Nurminen method for the difference in proportions, expressed as a percentage.||2.9|-3.2|
72410872|NCT04382326|144330108|NON_INFERIORITY|Noninferiority was declared if the lower bound of the 2-sided 95% CI for the percentage differences (20vPnC - 13vPnC) was greater than -10%.|Percentage Difference|0.0||||||95.0|-3.4|3.2||||||Poliovirus (Type 1): 2-Sided CI was calculated using the Miettinen and Nurminen method for the difference in proportions, expressed as a percentage.||3.2|-3.4|
72410873|NCT04382326|144330108|NON_INFERIORITY|Noninferiority was declared if the lower bound of the 2-sided 95% CI for the percentage differences (20vPnC - 13vPnC) was greater than -10%.|Percentage Difference|0.8||||||95.0|-2.4|4.6||||||Poliovirus (Type 2): 2-Sided CI was calculated using the Miettinen and Nurminen method for the difference in proportions, expressed as a percentage.||4.6|-2.4|
72410874|NCT04382326|144330108|NON_INFERIORITY|Noninferiority was declared if the lower bound of the 2-sided 95% CI for the percentage differences (20vPnC - 13vPnC) was greater than -10%.|Percentage Difference|0.0||||||95.0|-3.2|3.1||||||Poliovirus (Type 3): 2-Sided CI was calculated using the Miettinen and Nurminen method for the difference in proportions, expressed as a percentage.||3.1|-3.2|
72410875|NCT04382326|144330108|NON_INFERIORITY|Noninferiority was declared if the lower bound of the 2-sided 95% CI for the percentage differences (20vPnC - 13vPnC) was greater than -10%.|Percentage Difference|0.0|||||TWO_SIDED|95.0|-3.0|3.0||||||Hib (≥0.15 μg/mL): 2-Sided CI were calculated using the Miettinen and Nurminen method for the difference in proportions, expressed as a percentage.||3.0|-3.0|
72410876|NCT04382326|144330109|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC is to the corresponding serotype in 13vPnC group. Noninferiority was declared for if the lower bound of the 2-sided 95% CI for the IgG GMR of 20vPnC to 13vPnC for the serotype is greater than 0.5 (2-fold NI margin).|Geometric Mean Ratios|0.65|||||TWO_SIDED|95.0|0.59|0.72||||||Serotype 1: GMR and 2-Sided CI were calculated by exponentiating the mean difference (20vPnC-13vPnC) of the logarithms of the IgG concentrations and the corresponding CI (based on the Student's t distribution).||0.72|0.59|
72410877|NCT04382326|144330109|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC is to the corresponding serotype in 13vPnC group. Noninferiority was declared for if the lower bound of the 2-sided 95% CI for the IgG GMR of 20vPnC to 13vPnC for the serotype is greater than 0.5 (2-fold NI margin).|Geometric Mean Ratio|0.7|||||TWO_SIDED|95.0|0.64|0.76||||||Serotype 3: GMR and 2-Sided CI were calculated by exponentiating the mean difference (20vPnC-13vPnC) of the logarithms of the IgG concentrations and the corresponding CI (based on the Student's t distribution).||0.76|0.64|
72410878|NCT04382326|144330109|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC is to the corresponding serotype in 13vPnC group. Noninferiority was declared for if the lower bound of the 2-sided 95% CI for the IgG GMR of 20vPnC to 13vPnC for the serotype is greater than 0.5 (2-fold NI margin).|Geometric Mean Ratio|0.7||||||95.0|0.63|0.78||||||Serotype 4: GMR and 2-Sided CI were calculated by exponentiating the mean difference (20vPnC-13vPnC) of the logarithms of the IgG concentrations and the corresponding CI (based on the Student's t distribution).||0.78|0.63|
72410879|NCT04382326|144330109|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC is to the corresponding serotype in 13vPnC group. Noninferiority was declared for if the lower bound of the 2-sided 95% CI for the IgG GMR of 20vPnC to 13vPnC for the serotype is greater than 0.5 (2-fold NI margin).|Geometric Mean Ratio|0.69||||||95.0|0.61|0.77||||||Serotype 5: GMR and 2-Sided CI were calculated by exponentiating the mean difference (20vPnC-13vPnC) of the logarithms of the IgG concentrations and the corresponding CI (based on the Student's t distribution).||0.77|0.61|
72543114|NCT00185211|144616540|SUPERIORITY_OR_OTHER|||||||0.0027||95.0||||A 2-sided error level of 0.0253 was used for analyses at month 36 and 60 in order to keep the study-wise error level at 0.05. A conditional sequential testing approach was used for the family of null hypotheses of the primary efficacy variables.|Log Rank|||"The null hypothesis for comparison of initial IFNB-1b versus initial placebo treatment was:~H0: The survival functions (i.e., the probability that time to CDMS is ≥ t) are identical for both treatment arms for all points in time t\>0.~The two-sided alternative hypothesis was:~H1: The survival functions (i.e., the probability that time to CDMS is ≥ t) are not identical for both treatment arms for some points in time t\>0."||||0.0027
72543115|NCT00185211|144616540|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.663||||0.0028||97.47|0.488|0.902|||Regression, Cox|covariate adjustment: steroid use during first event, onset of disease, categorized number of T2 lesions at screening|The direction of comparison is initial IFNB-1b (numerator) versus initial placebo (denominator), i.e. the Hazard Ratio represents the relative risk of initial IFNB-1b treatment compared to initial placebo treatment.|Time to CDMS was modelled by a Cox proportional hazards regression model with the following covariates: treatment group, steroid use during first event (yes vs. no), onset of disease (monofocal vs. multifocal) and number of T2 lesions at screening (categories: 2-4, 5-8 and at least 9 T2 lesions). The null hypothesis was: Initial IFNB-1b and initial placebo do not differ with regard to the hazard for CDMS, i.e. hazard ratio = 1.||0.902|0.488|0.0028
72543116|NCT00185211|144616541|SUPERIORITY_OR_OTHER|||||||0.1768||95.0||||A 2-sided error level of 0.0253 was used for analyses at month 36 and 60 in order to keep the study-wise error level at 0.05. A conditional sequential testing approach was used for the family of null hypotheses of the primary efficacy variables.|Log Rank|||The null hypothesis for comparison of initial IFNB-1b versus initial placebo treatment was: H0: The survival functions (i.e., the probability that time to confirmed EDSS progression is ≥ t) are not identical for both treatment arms for some points in time t\>0. The two-sided alternative hypothesis was: H1: The survival functions (i.e., the probability that time to confirmed EDSS progression is ≥ t) are identical for both treatment arms for some points in time t\>0.||||0.1768
72543117|NCT00185211|144616541|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.764||||0.1604||97.47|0.497|1.174|||Regression, Cox|The variable used as additional covariate adjustment was volume of T2 lesions on screening MRI.|The direction of comparison is initial IFNB-1b (numerator) versus initial placebo (denominator), i.e. the Hazard Ratio represents the relative risk of initial IFNB-1b treatment compared to initial placebo treatment.|Time to confirmed EDSS progression was modelled by a Cox proportional hazards regression model with the following covariates: treatment group and volume of T2 lesions on screening MRI. The null hypothesis was: Initial IFNB-1b and initial placebo do not differ with regard to the hazard for confirmed EDSS progression, i.e. hazard ratio = 1.||1.174|0.497|0.1604
72543118|NCT00185211|144616542|SUPERIORITY_OR_OTHER|||||||0.888||95.0||||A 2-sided error level of 0.0253 was used for analyses at month 36 and 60 in order to keep the study-wise error level at 0.05. A conditional sequential testing approach was used for the family of null hypotheses of the primary efficacy variables.|non-parametric ANCOVA|Variable used as covariate: FAMS TOI measured at baseline||"The null hypothesis H0: The distribution of FAMS TOI at month 60, adjusted for baseline FAMS TOI, is identical for both treatment arms was tested against the alternative hypothesis HA: The distribution of FAMS TOI at month 60, adjusted for baseline FAMS TOI, is not the same in the two treatment arms using a non-parametric analysis of covariance (ANCOVA)."||||0.8880
72543119|NCT00185211|144616542|SUPERIORITY_OR_OTHER|||||||0.3832||95.0|||||ANCOVA|Variable used as covariate: FAMS TOI measured at baseline||"The null hypothesis H0: The mean FAMS TOI at month 60, adjusted for baseline FAMS TOI, is identical for both treatment arms was tested against the alternative hypothesis HA: The mean FAMS TOI at month 60, adjusted for baseline FAMS TOI, is not the same in the two treatment arms using a parametric analysis of covariance (ANCOVA)."||||0.3832
72543120|NCT00185211|144616543|SUPERIORITY_OR_OTHER|||||||6e-06||95.0||||The two-sided error level for the exploratory analysis of the secondary outcome measures was of 0.05.|Log Rank|||"The null hypothesis for comparison of initial IFNB-1b versus initial placebo treatment was:~H0: The survival functions (i.e., the probability that time to McDonald MS is ≥ t) are identical for both treatment arms for all points in time t\>0.~The two-sided alternative hypothesis was:~H1: The survival functions (i.e., the probability that time to McDonald MS is ≥ t) are not identical for both treatment arms for some points in time t\>0."||||0.000006
72543121|NCT00185211|144616543|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.583|||<|1e-06||95.0|0.474|0.718|||Regression, Cox|covariate adjustment: steroid use during first event, onset of disease, categorized number of T2 lesions at screening|The direction of comparison is initial IFNB-1b versus initial placebo, i.e. the Hazard Ratio represents the relative risk of initial IFNB-1b treatment compared to initial placebo treatment.|Time to McDonald MS was modelled by a Cox proportional hazards regression model with the following covariates: treatment group, steroid use during first event (yes vs. no), onset of disease (monofocal vs. multifocal) and number of T2 lesions at screening (categories: 2-4, 5-8 and at least 9 T2 lesions). The null hypothesis was: Initial IFNB-1b and initial placebo do not differ with regard to the hazard for McDonald MS, i.e. hazard ratio = 1.||0.718|0.474|< 0.000001
72552595|NCT01015625|144636040|SUPERIORITY|A two-sided significance level of 5% was used.|Cox Proportional Hazard|1.45||||0.147|TWO_SIDED|95.0|0.87|2.42|||Log Rank||From the Cox Proportional hazard model with surgery vs no surgery fitted as a covariate. A hazard ratio \> 1.0 indicates a higher average event rate and a shorter time to distant progression for surgery relative to no surgery.|To determine the effect of local therapy (surgery) compared to systemic therapy only in synchronous metastasized breast cancer patients in terms of time from randomization to distant progression. Distant progression is defined as detection of new lesions or progression of existing metastases in locations different then breast. Participants last known to be alive without a distant progression were censored at their last contact date or at the data cut-off date whichever came first.||2.42|0.87|0.147
72577718|NCT04784533|144682706|SUPERIORITY||Difference in percentages|19.5|||||TWO_SIDED|95.0|8.1|31.0|||||Treatment difference is calculated as the difference between the percentage of responders in the 12 mg BID group versus the 8 mg BID group.|Week 24||31.0|8.1|
72577719|NCT04784533|144682707|SUPERIORITY||LS Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.16|||TWO_SIDED|95.0|-0.9|-0.3|||||LS means, SE, and CIs are based on an MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value. The model is fit using an unstructured covariance structure.|Week 12||-0.3|-0.9|
72577720|NCT04784533|144682707|SUPERIORITY||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.18|||TWO_SIDED|95.0|-1.1|-0.4|||||LS means, SE, and CIs are based on an MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value. The model is fit using an unstructured covariance structure.|Week 16||-0.4|-1.1|
72577721|NCT04784533|144682707|SUPERIORITY||LS Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.19|||TWO_SIDED|95.0|-1.2|-0.4|||||LS means, SE, and CIs are based on an MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value. The model is fit using an unstructured covariance structure.|Week 20||-0.4|-1.2|
72543122|NCT00185211|144616544|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.797||||0.1265||95.0|0.595|1.066||The two-sided error level for the exploratory analysis of the secondary outcome measures was of 0.05.|Andersen-Gill Model|Covariate adjustment: steroid use during first event, onset of disease, categorized number of T2 lesions at screening|The direction of comparison is initial IFNB-1b (numerator) versus initial placebo (denominator), i.e. the Hazard Ratio represents the relative risk of initial IFNB-1b treatment compared to initial placebo treatment.|The time to recurrent relapses was modelled by an extension of Cox's PH regression model (Andersen-Gill Model) for recurrent events with the following covariates: treatment group, steroid use during first event (yes vs. no), onset of disease (monofocal vs. multifocal) and number of T2 lesions at screening (2-4, 5-8 and at least 9 T2 lesions). The null hypothesis was: Initial IFNB-1b and initial placebo do not differ with regard to the hazard for recurrent relapses, i.e. hazard ratio = 1.||1.066|0.595|0.1265
72577722|NCT04784533|144682707|SUPERIORITY||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.2|||TWO_SIDED|95.0|-1.2|-0.3|||||LS means, SE, and CIs are based on an MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value. The model is fit using an unstructured covariance structure.|Week 24||-0.3|-1.2|
72577723|NCT04784533|144682708|SUPERIORITY||Least Square (LS) Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.16|||TWO_SIDED|95.0|-0.7|-0.1|||||LS means, SE, and CIs are based on an MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score. The model is fit using an unstructured covariance structure.|Week 12||-0.1|-0.7|
72577724|NCT04784533|144682708|SUPERIORITY||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.18|||TWO_SIDED|95.0|-1.0|-0.3|||||LS means, SE, and CIs are based on an MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score. The model is fit using an unstructured covariance structure.|Week 16||-0.3|-1.0|
72577725|NCT04784533|144682708|SUPERIORITY||LS Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.18|||TWO_SIDED|95.0|-1.2|-0.5|||||LS means, SE, and CIs are based on an MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score. The model is fit using an unstructured covariance structure.|Week 20||-0.5|-1.2|
72577726|NCT04784533|144682708|SUPERIORITY||LS Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.21|||TWO_SIDED|95.0|-1.2|-0.4|||||LS means, SE, and CIs are based on an MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score. The model is fit using an unstructured covariance structure.|Week 24||-0.4|-1.2|
72577727|NCT04784533|144682709|SUPERIORITY||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.13|||TWO_SIDED|95.0|-0.7|-0.2|||||LS means, SEs, and CIs are based on a mixed model repeated measures analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score. The model is fit using an unstructured covariance structure.|Satisfied Thickness Hair Coverage: Week 12||-0.2|-0.7|
72577728|NCT04784533|144682709|SUPERIORITY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.13|||TWO_SIDED|95.0|-0.7|-0.2|||||LS means, SEs, and CIs are based on a mixed model repeated measures analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score. The model is fit using an unstructured covariance structure.|Satisfied Thickness Hair Coverage: Week 16||-0.2|-0.7|
72577729|NCT04784533|144682709|SUPERIORITY||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.13|||TWO_SIDED|95.0|-0.8|-0.3|||||LS means, SEs, and CIs are based on a mixed model repeated measures analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score. The model is fit using an unstructured covariance structure.|Satisfied Thickness Hair Coverage: Week 20||-0.3|-0.8|
72577730|NCT04784533|144682709|SUPERIORITY||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|-0.8|-0.2|||||LS means, SEs, and CIs are based on a mixed model repeated measures analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score. The model is fit using an unstructured covariance structure.|Satisfied Thickness Hair Coverage: Week 24||-0.2|-0.8|
72577731|NCT04784533|144682709|SUPERIORITY||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.12|||TWO_SIDED|95.0|-0.8|-0.3|||||LS means, SEs, and CIs are based on a mixed model repeated measures analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score. The model is fit using an unstructured covariance structure.|Satisfied Evenness Hair Coverage: Week 12||-0.3|-0.8|
72577732|NCT04784533|144682709|SUPERIORITY||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.12|||TWO_SIDED|95.0|-0.7|-0.3|||||LS means, SEs, and CIs are based on a mixed model repeated measures analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score. The model is fit using an unstructured covariance structure.|Satisfied Evenness Hair Coverage: Week 16||-0.3|-0.7|
72577733|NCT04784533|144682709|SUPERIORITY||LS Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.13|||TWO_SIDED|95.0|-0.8|-0.3|||||LS means, SEs, and CIs are based on a mixed model repeated measures analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score. The model is fit using an unstructured covariance structure.|Satisfied Evenness Hair Coverage: Week 20||-0.3|-0.8|
72577734|NCT04784533|144682709|SUPERIORITY||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|-0.8|-0.3|||||LS means, SEs, and CIs are based on a mixed model repeated measures analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score. The model is fit using an unstructured covariance structure.|Satisfied Evenness Hair Coverage: Week 24||-0.3|-0.8|
72577735|NCT04784533|144682709|SUPERIORITY||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|-0.8|-0.2|||||LS means, SEs, and CIs are based on a mixed model repeated measures analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score. The model is fit using an unstructured covariance structure.|How Satisfied With Your Eyebrows: Week 12||-0.2|-0.8|
72410880|NCT04382326|144330109|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC is to the corresponding serotype in 13vPnC group. Noninferiority was declared for if the lower bound of the 2-sided 95% CI for the IgG GMR of 20vPnC to 13vPnC for the serotype is greater than 0.5 (2-fold NI margin).|Geometric Mean Ratio|0.72||||||95.0|0.65|0.81||||||Serotype 6A: GMR and 2-Sided CI were calculated by exponentiating the mean difference (20vPnC-13vPnC) of the logarithms of the IgG concentrations and the corresponding CI (based on the Student's t distribution).||0.81|0.65|
72410881|NCT04382326|144330109|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC is to the corresponding serotype in 13vPnC group. Noninferiority was declared for if the lower bound of the 2-sided 95% CI for the IgG GMR of 20vPnC to 13vPnC for the serotype is greater than 0.5 (2-fold NI margin).|Geometric Mean Ratio|0.6|||||TWO_SIDED|95.0|0.51|0.7||||||Serotype 6B: GMR and 2-Sided CI were calculated by exponentiating the mean difference (20vPnC-13vPnC) of the logarithms of the IgG concentrations and the corresponding CI (based on the Student's t distribution).||0.70|0.51|
72410882|NCT04382326|144330109|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC is to the corresponding serotype in 13vPnC group. Noninferiority was declared for if the lower bound of the 2-sided 95% CI for the IgG GMR of 20vPnC to 13vPnC for the serotype is greater than 0.5 (2-fold NI margin).|Geometric Mean Ratio|0.75||||||95.0|0.69|0.81||||||Serotype 7F: GMR and 2-Sided CI were calculated by exponentiating the mean difference (20vPnC-13vPnC) of the logarithms of the IgG concentrations and the corresponding CI (based on the Student's t distribution).||0.81|0.69|
72410883|NCT04382326|144330109|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC is to the corresponding serotype in 13vPnC group. Noninferiority was declared for if the lower bound of the 2-sided 95% CI for the IgG GMR of 20vPnC to 13vPnC for the serotype is greater than 0.5 (2-fold NI margin).|Geometric Mean Ratio|0.72|||||TWO_SIDED|95.0|0.65|0.8||||||Serotype 9V: GMR and 2-Sided CI were calculated by exponentiating the mean difference (20vPnC-13vPnC) of the logarithms of the IgG concentrations and the corresponding CI (based on the Student's t distribution).||0.80|0.65|
72410884|NCT04382326|144330109|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC is to the corresponding serotype in 13vPnC group. Noninferiority was declared for if the lower bound of the 2-sided 95% CI for the IgG GMR of 20vPnC to 13vPnC for the serotype is greater than 0.5 (2-fold NI margin).|Geometric Mean Ratio|0.79||||||95.0|0.71|0.89||||||Serotype 14: GMR and 2-Sided CI were calculated by exponentiating the mean difference (20vPnC-13vPnC) of the logarithms of the IgG concentrations and the corresponding CI (based on the Student's t distribution).||0.89|0.71|
72410885|NCT04382326|144330109|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC is to the corresponding serotype in 13vPnC group. Noninferiority was declared for if the lower bound of the 2-sided 95% CI for the IgG GMR of 20vPnC to 13vPnC for the serotype is greater than 0.5 (2-fold NI margin).|Geometric Mean Ratio|0.77||||||95.0|0.7|0.84||||||Serotype 18C: GMR and 2-Sided CI were calculated by exponentiating the mean difference (20vPnC-13vPnC) of the logarithms of the IgG concentrations and the corresponding CI (based on the Student's t distribution).||0.84|0.70|
72577736|NCT04784533|144682709|SUPERIORITY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.13|||TWO_SIDED|95.0|-0.6|-0.1|||||LS means, SEs, and CIs are based on a mixed model repeated measures analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score. The model is fit using an unstructured covariance structure.|How Satisfied With Your Eyebrows: Week 16||-0.1|-0.6|
72577737|NCT04784533|144682709|SUPERIORITY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|-0.7|-0.1|||||LS means, SEs, and CIs are based on a mixed model repeated measures analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score. The model is fit using an unstructured covariance structure.|How Satisfied With Your Eyebrows: Week 20||-0.1|-0.7|
72410886|NCT04382326|144330109|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC is to the corresponding serotype in 13vPnC group. Noninferiority was declared for if the lower bound of the 2-sided 95% CI for the IgG GMR of 20vPnC to 13vPnC for the serotype is greater than 0.5 (2-fold NI margin).|Geometric Mean Ratio|0.79|||||TWO_SIDED|95.0|0.72|0.86||||||Serotype 19A: GMR and 2-Sided CI were calculated by exponentiating the mean difference (20vPnC-13vPnC) of the logarithms of the IgG concentrations and the corresponding CI (based on the Student's t distribution).||0.86|0.72|
72577738|NCT04784533|144682709|SUPERIORITY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|-0.7|-0.2|||||LS means, SEs, and CIs are based on a mixed model repeated measures analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score. The model is fit using an unstructured covariance structure.|How Satisfied With Your Eyebrows: Week 24||-0.2|-0.7|
72577739|NCT04784533|144682709|SUPERIORITY||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.13|||TWO_SIDED|95.0|-0.7|-0.2|||||LS means, SEs, and CIs are based on a mixed model repeated measures analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score. The model is fit using an unstructured covariance structure.|How Satisfied With Your Eyelashes: Week 12||-0.2|-0.7|
72421522|NCT01342458|144354201|SUPERIORITY_OR_OTHER|||||||0.019|TWO_SIDED||||||Mixed Models Analysis|||We used a casewise two-way ANOVA for repeated measures (two independent groups and three repeated measures/assessments), followed by a post hoc Newman-Keuls test to verify the interaction effect of group vs. time between T0 (baseline), T3 (3th month) and T6 (6th month).||||0.019
72577740|NCT04784533|144682709|SUPERIORITY||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.13|||TWO_SIDED|95.0|-0.7|-0.2|||||LS means, SEs, and CIs are based on a mixed model repeated measures analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score. The model is fit using an unstructured covariance structure.|How Satisfied With Your Eyelashes: Week 16||-0.2|-0.7|
72577741|NCT04784533|144682709|SUPERIORITY||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.13|||TWO_SIDED|95.0|-0.7|-0.2|||||LS means, SEs, and CIs are based on a mixed model repeated measures analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score. The model is fit using an unstructured covariance structure.|How Satisfied With Your Eyelashes: Week 20||-0.2|-0.7|
72577742|NCT04784533|144682709|SUPERIORITY||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|-0.8|-0.3|||||LS means, SEs, and CIs are based on a mixed model repeated measures analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score. The model is fit using an unstructured covariance structure.|How Satisfied With Your Eyelashes: Week 24||-0.3|-0.8|
72577743|NCT00307437|144682713|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel (CMH) chi square|Stratified by baseline weight \[less than or equal to 90 kg vs greater than 90 kg)\].||||||<0.001
72577744|NCT00307437|144682713|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||To control for the multiplicity for the primary endpoint analysis, the Holm's procedure was used at an overall significance level of 0.05.|Cochran-Mantel-Haenszel (CMH) chi square|Stratified by baseline weight \[less than or equal 90 kg vs greater than 90 kg)\].||Null Hypothesis: No difference between ustekinumab 90 mg or 45 mg and placebo at an overall significance level of 0.05. Sample Size: With 1200 participants (400 in each treatment group), simulation studies were conducted to calculate the power to detect a treatment difference in the primary endpoint between ustekinumab groups and placebo using a CMH test stratified by baseline weight \[\<=90kg vs \> 90 kg). For all the scenarios evaluated, the power is \>99% at an overall significance level of 0.05.||||<0.001
72577745|NCT00307437|144682714|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel (CMH) chi square|Stratified by baseline weight \[less than or equal 90 kg vs greater than 90 kg)\].||||||<0.001
72577746|NCT00307437|144682714|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||To control the multiplicity for the primary and the secondary endpoint analyses, Holm's procedure was used but the two comparisons for the primary endpoint need to be significant first.|Cochran-Mantel-Haenszel (CMH) chi square|Stratified by baseline weight \[less than or equal 90 kg vs greater than 90 kg)\].||Null Hypothesis: No difference between ustekinumab 90 mg or 45 mg and placebo at an overall significancd level of 0.05.||||<0.001
72577747|NCT00307437|144682715|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA on van der Waerden normal scores|Analysis of variance on van der Waerden normal scores (Conover, 1980) with treatment and baseline weight (≤ 90kg vs \> 90 kg) as factors in the model||||||<0.001
72577748|NCT00307437|144682715|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||To control the multiplicity for the primary and the secondary endpoint analyses, Holm's procedure was used but the two comparisons for the primary endpoint and the two comparisons for the 1st second endpoint analyses need to be significant first.|ANOVA on van der Waerden normal scores|Analysis of varianceon van der Waerden normal scores (Conover, 1980) with treatment and baseline weight (≤90 kg vs \>90 kg) as factors in the model||Null Hypothesis: No difference between ustekinumab 90 mg or 45 mg and placebo at an overall significance level of 0.05.||||<0.001
72577749|NCT00307437|144682716|SUPERIORITY_OR_OTHER|||||||0.468||95.0|||||Cochran-Mantel-Haenszel (row mean score)|Stratified by baseline weight \[less than or equal to 90 kg vs greater than 90 kg)\].||||||0.468
72577750|NCT00307437|144682716|SUPERIORITY_OR_OTHER|||||||0.21||95.0|||||Cochran-Mantel-Haenszel (row mean score)|Stratified by baseline weight \[less than or equal to 90 kg vs greater than 90 kg)\].||||||0.210
72577751|NCT00307437|144682716|SUPERIORITY_OR_OTHER|||||||0.014||95.0||||To control the overall multiplicity, the combined groups was tested first and each dose will then be tested; but the primary and the 1st 2 secondary endpoint analyses need to be significant before this endpoint can be tested.|Cochran-Mantel-Haenszel (row mean score)|Stratified by baseline weight \[less than or equal to 90 kg vs greater than 90 kg)\].||Null Hypothesis: No difference between combined q8 group and the combined q12 group, 45 mg q8 and 45 mg q12, 90 mg q8 and 90 mg q12 at an overall significance level of 0.05.||||0.014
72577752|NCT01613313|144682753|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|50.0|||||TWO_SIDED|||||||No p value||This is a proof of concept dose escalation study. No power justification has been implemented. Descriptive data provided for each arm.||||
72577753|NCT01613313|144682754|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|50.0|||||TWO_SIDED|||||||||This is a proof of concept dose escalation study. No power of justification was implemented. Descriptive statistics was provided for each arm only.||||
72577754|NCT02766283|144682762|SUPERIORITY_OR_OTHER|||||||0.9|||||||Chi-squared|||||||0.90
72577755|NCT02766283|144682763|SUPERIORITY_OR_OTHER|||||||0.022|||||||Chi-squared|||||||0.022
72577756|NCT00708227|144682771|SUPERIORITY|||||||0.27|||||||ANOVA|||||||0.27
72577757|NCT00708227|144682772|SUPERIORITY|||||||0.15|||||||ANOVA|||||||0.15
72577758|NCT00708227|144682773|SUPERIORITY|||||||0.06|||||||ANOVA|||||||0.06
72410887|NCT04382326|144330109|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC is to the corresponding serotype in 13vPnC group. Noninferiority was declared for if the lower bound of the 2-sided 95% CI for the IgG GMR of 20vPnC to 13vPnC for the serotype is greater than 0.5 (2-fold NI margin).|Geometric Mean Ratio|0.79||||||95.0|0.73|0.86||||||Serotype 19F: GMR and 2-Sided CI were calculated by exponentiating the mean difference (20vPnC-13vPnC) of the logarithms of the IgG concentrations and the corresponding CI (based on the Student's t distribution).||0.86|0.73|
72410888|NCT04382326|144330109|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC is to the corresponding serotype in 13vPnC group. Noninferiority was declared for if the lower bound of the 2-sided 95% CI for the IgG GMR of 20vPnC to 13vPnC for the serotype is greater than 0.5 (2-fold NI margin).|Geometric Mean Ratio|0.66|||||TWO_SIDED|95.0|0.58|0.75||||||Serotype 23F: GMR and 2-Sided CI were calculated by exponentiating the mean difference (20vPnC-13vPnC) of the logarithms of the IgG concentrations and the corresponding CI (based on the Student's t distribution).||0.75|0.58|
72410889|NCT04382326|144330109|NON_INFERIORITY|For the additional 7 serotypes, the compared results are from serotype 19A (13vPnC serotype with the lowest GMC, not including serotype 3) in the 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/lowest 13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|1.98||||||95.0|1.81|2.16||||||Serotype 8: GMR and 2-Sided CI were calculated by exponentiating the mean difference (20vPnC - lowest 13vPnC) of the logarithms of the IgG concentrations and the corresponding CI (based on the Student's t distribution).||2.16|1.81|
72410890|NCT04382326|144330109|NON_INFERIORITY|For the additional 7 serotypes, the compared results are from serotype 19A (13vPnC serotype with the lowest GMC, not including serotype 3) in the 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/lowest 13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|1.32||||||95.0|1.18|1.49||||||Serotype 10A: GMR and 2-Sided CI were calculated by exponentiating the mean difference (20vPnC - lowest 13vPnC) of the logarithms of the IgG concentrations and the corresponding CI (based on the Student's t distribution).||1.49|1.18|
72410891|NCT04382326|144330109|NON_INFERIORITY|For the additional 7 serotypes, the compared results are from serotype 19A (13vPnC serotype with the lowest GMC, not including serotype 3) in the 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/lowest 13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|1.52||||||95.0|1.39|1.67||||||Serotype 11A: GMR and 2-Sided CI were calculated by exponentiating the mean difference (20vPnC - lowest 13vPnC) of the logarithms of the IgG concentrations and the corresponding CI (based on the Student's t distribution).||1.67|1.39|
72410892|NCT04382326|144330109|NON_INFERIORITY|For the additional 7 serotypes, the compared results are from serotype 19A (13vPnC serotype with the lowest GMC, not including serotype 3) in the 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/lowest 13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|0.6||||||95.0|0.54|0.67||||||Serotype 12F: GMR and 2-Sided CI were calculated by exponentiating the mean difference (20vPnC - lowest 13vPnC) of the logarithms of the IgG concentrations and the corresponding CI (based on the Student's t distribution).||0.67|0.54|
72410893|NCT04382326|144330109|NON_INFERIORITY|For the additional 7 serotypes, the compared results are from serotype 19A (13vPnC serotype with the lowest GMC, not including serotype 3) in the 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/lowest 13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|4.82|||||TWO_SIDED|95.0|4.39|5.3||||||Serotype 15B: GMR and 2-Sided CI were calculated by exponentiating the mean difference (20vPnC - lowest 13vPnC) of the logarithms of the IgG concentrations and the corresponding CI (based on the Student's t distribution).||5.30|4.39|
72410894|NCT04382326|144330109|NON_INFERIORITY|For the additional 7 serotypes, the compared results are from serotype 19A (13vPnC serotype with the lowest GMC, not including serotype 3) in the 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/lowest 13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|4.06||||||95.0|3.68|4.48||||||Serotype 22F: GMR and 2-Sided CI were calculated by exponentiating the mean difference (20vPnC - lowest 13vPnC) of the logarithms of the IgG concentrations and the corresponding CI (based on the Student's t distribution).||4.48|3.68|
72410895|NCT04382326|144330109|NON_INFERIORITY|For the additional 7 serotypes, the compared results are from serotype 19A (13vPnC serotype with the lowest GMC, not including serotype 3) in the 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/lowest 13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|1.64||||||95.0|1.46|1.83||||||Serotype 33F: GMR and 2-Sided CI were calculated by exponentiating the mean difference (20vPnC - lowest 13vPnC) of the logarithms of the IgG concentrations and the corresponding CI (based on the Student's t distribution).||1.83|1.46|
72410896|NCT04382326|144330117|NON_INFERIORITY|Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR of 20vPnC group to 13vPnC group is greater than 0.5 (2-fold NI margin).|Geometric Mean Ratios|1.29||||||95.0|1.05|1.58||||||Measles: GMR and 2-Sided CI were calculated by exponentiating the mean difference (20vPnC - 13vPnC) of the logarithms of the concentrations and the corresponding CI (based on the Student's t distribution).||1.58|1.05|
72410897|NCT04382326|144330118|NON_INFERIORITY|Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR of 20vPnC group to 13vPnC group is greater than 0.5 (2-fold NI margin).|Geometric Mean Ratios|1.08|||||TWO_SIDED|95.0|0.85|1.38||||||Mumps: GMR and 2-Sided CI were calculated by exponentiating the mean difference (20vPnC - 13vPnC) of the logarithms of the concentrations and the corresponding CI (based on the Student's t distribution).||1.38|0.85|
72421523|NCT01342458|144354201|SUPERIORITY_OR_OTHER||Effect size|1.07|||<|0.001|TWO_SIDED||||||post hoc Newman-Keuls|||From baseline to 3rd month.||||<0.001
72577759|NCT04007991|144682778|SUPERIORITY||Difference in Least Square Mean|-3.44|STANDARD_ERROR_OF_MEAN|1.351|=|0.011|TWO_SIDED|95.0|-6.09|-0.79||Change from baseline in YGTSS score as a continuous variable was based on mixed model for repeated measures (MMRM) analysis of covariance (ANCOVA) model with an unstructured covariance matrix.|ANCOVA|||||-0.79|-6.09|=0.011
72577760|NCT02640482|144682805|NON_INFERIORITY|The noninferiority of the rate of sustained virologic response at 12 weeks after treatment for Arm A as compared with the historical rate for patients treated with the current standard of care (SOF + RBV for 12 weeks) was analyzed; the lower confidence bound of the 2-sided 95% confidence interval (95% CI) for the percentage of participants with sustained virologic response at 12 weeks after treatment must exceed 89% to achieve noninferiority.|Percentage of Participants|99.5|||||TWO_SIDED|95.0|98.5|100.0||||||Based on a 2-sided significance level of 0.05 and an underlying rate of ≥96% in the Arm A (180 participants) provides \>90% power to demonstrate noninferiority of ABT-493/ABT-530 to the historical rate for patients treated with the current standard of care (SOF + RBV for 12 weeks) (95%) (based on the normal approximation of using a single binomial proportion a one-sample test for superiority).||100.0|98.5|
72577761|NCT02640482|144682806|SUPERIORITY|The superiority of the rate of sustained virologic response at 12 weeks after treatment for Arm A as compared with the historical rate for patients treated with the current standard of care (SOF + RBV for 12 weeks) was analyzed; the lower confidence bound of the 2-sided 95% confidence interval (95% CI) for the percentage of participants with sustained virologic response at 12 weeks after treatment must exceed 95% to achieve superiority.|Percentage of Participants|99.5|||||TWO_SIDED|95.0|98.5|100.0||||||Based on a 2-sided significance level of 0.05 and an underlying rate of ≥96% in the Arm A (180 participants) provides \>90% power to demonstrate superiority of ABT-493/ABT-530 to the historical rate for patients treated with the current standard of care (SOF + RBV for 12 weeks) (95%) (based on the normal approximation of a single binomial proportion using a one-sample test for superiority).||100.0|98.5|
72577762|NCT02462291|144682821|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.27||||1|TWO_SIDED|95.0|-7.9|5.4|||ANOVA|||Baseline||5.4|-7.9|1
72577763|NCT02462291|144682821|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|33.3|||<|0.01|TWO_SIDED|95.0|26.4|40.2|||ANOVA|||After the treatment||40.2|26.4|<0.01
72577764|NCT02462291|144682821|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-31.5|||<|0.01|TWO_SIDED|95.0|-38.2|-24.8|||ANOVA|||PRE Vs POST||-24.8|-38.2|<0.01
72577765|NCT02462291|144682821|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.1||||1|TWO_SIDED|95.0|-3.7|9.9|||ANOVA|||PRE Vs POST||9.9|-3.7|1
72577766|NCT02462291|144682822|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.14||||1|TWO_SIDED|95.0|-0.8|0.5|||ANOVA|||Baseline||0.5|-0.8|1
72577767|NCT02462291|144682822|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.94|||<|0.01|TWO_SIDED|95.0|-2.6|-1.2|||ANOVA|||After the treatment||-1.2|-2.6|<0.01
72577768|NCT02462291|144682822|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.94|||<|0.01|TWO_SIDED|95.0|0.28|1.61|||ANOVA|||PRE Vs POST||1.61|0.28|<0.01
72577769|NCT02462291|144682822|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.84|||<|0.01|TWO_SIDED|95.0|-1.52|-0.17|||ANOVA|||PRE Vs POST||-0.17|-1.52|<0.01
72577770|NCT02462291|144682823|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.74|||=|0.84|TWO_SIDED|95.0|-3.6|2.1|||ANOVA|||Baseline||2.1|-3.6|= 0.84
72577771|NCT02462291|144682823|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.31|||=|0.9|TWO_SIDED|95.0|-4.3|1.7|||ANOVA|||After the treatment||1.7|-4.3|= 0.9
72577772|NCT02462291|144682823|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.22||||0.88|TWO_SIDED|95.0|-3.14|2.69|||ANOVA|||PRE Vs POST||2.69|-3.14|0.88
72577773|NCT02462291|144682823|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.78||||0.89|TWO_SIDED|95.0|-3.73|2.16|||ANOVA|||PRE Vs POST||2.16|-3.73|0.89
72577774|NCT02462291|144682824|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.37||||0.9|TWO_SIDED|95.0|-5.48|2.73|||ANOVA|||Baseline||2.73|-5.48|0.9
72577775|NCT02462291|144682824|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.62||||0.59|TWO_SIDED|95.0|-1.6|6.9|||ANOVA|||After the treatment||6.90|-1.60|0.59
72577776|NCT02462291|144682824|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.99||||0.34|TWO_SIDED|95.0|-7.15|1.16|||ANOVA|||PRE Vs POST||1.16|-7.15|0.34
72577777|NCT02462291|144682824|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.03||||0.9|TWO_SIDED|95.0|-3.17|5.23|||ANOVA|||PRE Vs POST||5.23|-3.17|0.9
72577778|NCT02462291|144682825|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.36||||0.83|TWO_SIDED|95.0|-1.41|2.14|||ANOVA|||Baseline||2.14|-1.41|0.83
72577779|NCT02462291|144682825|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.69|||<|0.01|TWO_SIDED|95.0|0.84|4.53|||ANOVA|||After the treatment||4.53|0.84|<0.01
72577780|NCT02462291|144682825|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.14||||0.01|TWO_SIDED|95.0|-3.94|-0.34|||ANOVA|||PRE Vs POST||-0.34|-3.94|0.010
72577781|NCT02462291|144682825|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.18||||0.84|TWO_SIDED|95.0|-1.64|2.0|||ANOVA|||PRE Vs POST||2.00|-1.64|0.84
72577782|NCT02462291|144682826|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.39||||0.11|TWO_SIDED|95.0|-0.16|2.95|||ANOVA|||Baseline||2.95|-0.16|0.11
72577783|NCT02462291|144682826|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.79||||0.7|TWO_SIDED|95.0|-0.81|2.41|||ANOVA|||After the treatment||2.41|-0.81|0.7
72577784|NCT02462291|144682826|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.4||||0.88|TWO_SIDED|95.0|-1.17|1.98|||ANOVA|||PRE Vs POST||1.98|-1.17|0.88
72577785|NCT02462291|144682826|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.19||||0.95|TWO_SIDED|95.0|-1.78|1.39|||ANOVA|||PRE Vs POST||1.39|-1.78|0.95
72577786|NCT02462291|144682827|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.13||||0.95|TWO_SIDED|95.0|-0.67|0.4|||ANOVA|||Baseline||0.40|-0.67|0.95
72577787|NCT02462291|144682827|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.43||||0.23|TWO_SIDED|95.0|-0.12|0.99|||ANOVA|||After the treatment||0.99|-0.12|0.23
72577788|NCT02462291|144682827|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.96|TWO_SIDED|95.0|-0.65|0.44|||ANOVA|||PRE Vs POST||0.44|-0.65|0.96
72577789|NCT02462291|144682827|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.46||||0.15|TWO_SIDED|95.0|-0.08|1.01|||ANOVA|||PRE Vs POST||1.01|-0.08|0.15
72577790|NCT02462291|144682828|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.06||||0.84|TWO_SIDED|95.0|-1.14|1.27|||ANOVA|||Baseline||1.27|-1.14|0.84
72577791|NCT02462291|144682828|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.28||||0.81|TWO_SIDED|95.0|-0.96|1.54|||ANOVA|||After the treatment||1.54|-0.96|0.81
72577792|NCT02462291|144682828|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.48||||0.86|TWO_SIDED|95.0|-1.71|0.74|||ANOVA|||PRE Vs POST||0.74|-1.71|0.86
72577793|NCT02462291|144682828|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.26||||0.75|TWO_SIDED|95.0|-1.49|0.97|||ANOVA|||PRE Vs POST||0.97|-1.49|0.75
72577794|NCT02462291|144682829|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.7||||0.94|TWO_SIDED|95.0|-74.4|44.9|||ANOVA|||Baseline||44.9|-74.4|0.94
72577795|NCT02462291|144682829|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.36||||0.87|TWO_SIDED|95.0|-53.47|70.2|||ANOVA|||After the treatment||70.20|-53.47|0.87
72577796|NCT02462291|144682829|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-29.7||||0.78|TWO_SIDED|95.0|-90.19|30.78|||ANOVA|||PRE Vs POST||30.78|-90.19|0.78
72577797|NCT02462291|144682829|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.6||||0.84|TWO_SIDED|95.0|-67.7|54.5|||ANOVA|||PRE Vs POST||54.5|-67.7|0.84
72577798|NCT02462291|144682830|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.41||||0.74|TWO_SIDED|95.0|-3.73|4.56|||ANOVA|||Baseline||4.56|-3.73|0.74
72577799|NCT02462291|144682830|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.25||||0.82|TWO_SIDED|95.0|-5.54|3.04|||ANOVA|||After the treatment||3.04|-5.54|0.82
72577800|NCT02462291|144682830|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.63||||0.59|TWO_SIDED|95.0|-3.57|4.82|||ANOVA|||PRE Vs POST||4.82|-3.57|0.59
72577801|NCT02462291|144682830|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.04||||0.69|TWO_SIDED|95.0|-5.28|3.19|||ANOVA|||PRE Vs POST||3.19|-5.28|0.69
72577802|NCT02462291|144682831|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.23||||0.9|TWO_SIDED|95.0|-0.64|1.09|||ANOVA|||Baseline||1.09|-0.64|0.9
72577803|NCT02462291|144682831|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.86|||<|0.01|TWO_SIDED|95.0|1.96|3.76|||ANOVA|||After the treatment||3.76|1.96|<0.01
72577804|NCT02462291|144682831|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.92|||<|0.01|TWO_SIDED|95.0|-3.8|-2.04|||ANOVA|||PRE Vs POST||-2.04|-3.80|<0.01
72577805|NCT02462291|144682831|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.28||||0.88|TWO_SIDED|95.0|-1.17|0.59|||ANOVA|||PRE Vs POST||0.59|-1.17|0.88
72577806|NCT02462291|144682832|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.17||||0.83|TWO_SIDED|95.0|-0.72|0.37|||ANOVA|||Baseline||0.37|-0.72|0.83
72577807|NCT02462291|144682832|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.72||||0.005|TWO_SIDED|95.0|0.15|1.29|||ANOVA|||After the treatment||1.29|0.15|0.005
72577808|NCT02462291|144682832|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.65||||0.013|TWO_SIDED|95.0|-1.21|-0.09|||ANOVA|||PRE Vs POST||-0.09|-1.21|0.013
72577809|NCT02462291|144682832|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.24||||0.87|TWO_SIDED|95.0|-0.31|0.81|||ANOVA|||PRE Vs POST||0.81|-0.31|0.87
72577810|NCT02462291|144682833|SUPERIORITY_OR_OTHER||Chi-squared value|0.542|||=|0.91|TWO_SIDED||||||Chi-squared||Power of performed test with alpha = 0.050: 0.082; 3 degrees of freedom|||||= 0.910
72577811|NCT02462291|144682834|SUPERIORITY_OR_OTHER||Chi-squared value|17.73|||<|0.001|TWO_SIDED||||||Chi-squared||Power of performed test with alpha = 0.050: 0.965; 3 degrees of freedom|||||<0.001
72577812|NCT02462291|144682835|SUPERIORITY_OR_OTHER||Chi-squared value|5.749||||0.124|TWO_SIDED||||||Chi-squared||Power of performed test with alpha = 0.050: 0.488; 3 degrees of freedom|||||0.124
72577813|NCT02462291|144682836|SUPERIORITY_OR_OTHER||Chi-squared value|0.008||||1|TWO_SIDED||||||Chi-squared||Power of performed test with alpha = 0.050: 0.050; 3 degrees of freedom|||||1
72577814|NCT02462291|144682837|SUPERIORITY_OR_OTHER||Chi-squared value|1.049||||0.789|TWO_SIDED||||||Chi-squared||Power of performed test with alpha = 0.050: 0.116; 3 degrees of freedom|||||0.789
72577815|NCT01753297|144682880|OTHER|||||||0.158|||||||Log Rank|||A two-sided log-rank test was used to compare time to BRFS between both treatment groups.|Analysis on BRFS was based on 61 BR events (comprised of 35 BR events in the active surveillance arm and 26 BR events in the triptorelin arm).|||0.158
72329453|NCT03037476|144184382|OTHER|General Linear Model|Slope|0.005||||0.956|TWO_SIDED|95.0|-0.186|0.197|||Mixed Models Analysis|Poisson Regression||Change in Past 3 Month Marijuana Use from Baseline to 12 Month Followup||0.197|-.186|.956
72421524|NCT01342458|144354201|SUPERIORITY_OR_OTHER||Effect size|1.31|||<|0.001|TWO_SIDED||||||post hoc Newman-Keuls|||From baseline to 6th month.||||<0.001
72543123|NCT00185211|144616545|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.7971||||0.0141||95.0|0.665|0.9554||The two-sided error level for the exploratory analysis of the secondary outcome measures was of 0.05.|generalized linear Poisson regression|covariate adjustment: steroid use during first event, onset of disease, categorized number of T2 lesions at screening|The direction of comparison is initial IFNB-1b (numerator) versus initial placebo (denominator), i.e. the Risk Ratio represents the relative risk of initial IFNB-1b treatment compared to initial placebo treatment.|Relapse rate was analyzed by a generalized linear Poisson regression model with individual relapse counts as dependent variable, covariates: treatment arm, steroid use during first event, onset of disease and categorized number of T2 lesions at screening and offset variable natural log of time (in years) as difference between last clinical visit and baseline visit. The treatment effect on the relapse rate was of primary interest.||0.9554|0.6650|0.0141
72543124|NCT00185211|144616546|SUPERIORITY_OR_OTHER|||||||0.6078||95.0||||The two-sided error level for the exploratory analysis of the secondary outcome measures was of 0.05.|non-parametric ANCOVA|Variable used as covariate: MSFC Z-scores measured at baseline||"The null hypothesis H0: The distribution of MSFC Z-scores at month 60 adjusted for baseline MSFC Z-score is identical for both treatment arms was tested against the alternative hypothesis HA: The distribution of MSFC Z-scores at month 60 adjusted for baseline MSFC Z-score is not the same in the two treatment groups based on a non-parametric analysis of covariance (ANCOVA)."||||0.6078
72577816|NCT01753297|144682880|OTHER||Hazard Ratio (HR)|0.65||||0.1|TWO_SIDED|95.0|0.38|1.09|||Regression, Cox|||"Comparison between treatment groups: Triptorelin compared to Active surveillance.~A Cox proportional hazard model was fitted to compute hazards ratios (HRs) and the corresponding 95% CIs with treatment group, country (China as reference), centre (the largest centre as reference), and Gleason score on prostatectomy specimen (in categories: ≤6 / =7 / ≥8, with ≤6 considered as the reference) as fixed factors."||1.09|0.38|0.100
72577817|NCT01753297|144682880|OTHER||Hazard Ratio (HR)|1.49||||0.502|TWO_SIDED|95.0|0.46|4.79|||Regression, Cox|||"Comparison between countries: Russia compared to China.~A Cox proportional hazard model was fitted to compute HRs and the corresponding 95% CIs with treatment group, country (China as reference), centre (the largest centre as reference), and Gleason score on prostatectomy specimen (in categories: ≤6 / =7 / ≥8, with ≤6 considered as the reference) as fixed factors."|Interactions effect between treatment group and each covariate (country, centre(country) and Gleason score) were tested one by one in separate models. An interaction effect was considered as significant if p-value was \<0.20. Interaction between treatment group and country: p=0.970.|4.79|0.46|0.502
72577818|NCT01753297|144682880|OTHER|||||||0.671|||||||Regression, Cox|||"Centre effect.~A Cox proportional hazard model was fitted to compute HRs and the corresponding 95% CIs with treatment group, country (China as reference), centre (the largest centre as reference), and Gleason score on prostatectomy specimen (in categories: ≤6 / =7 / ≥8, with ≤6 considered as the reference) as fixed factors."|Interactions effect between treatment group and each covariate (country, centre(country) and Gleason score) were tested one by one in separate models. An interaction effect was considered as significant if p-value was \<0.20. Interaction between treatment group and centre: p=0.241.|||0.671
72577819|NCT01753297|144682880|OTHER||Hazard Ratio (HR)|2.35||||0.093|TWO_SIDED|95.0|0.87|6.39|||Regression, Cox|||"Comparison between Gleason score categories: Gleason score of =7 compared to Gleason score ≤6.~A Cox proportional hazard model was fitted to compute HRs and the corresponding 95% CIs with treatment group, country (China as reference), centre (the largest centre as reference), and Gleason score on prostatectomy specimen (in categories: ≤6 / =7 / ≥8, with ≤6 considered as the reference) as fixed factors."|Interactions effect between treatment group and each covariate (country, centre(country) and Gleason score) were tested one by one in separate models. An interaction effect was considered as significant if p-value was \<0.20. Interaction between treatment group and Gleason score: p=0.272.|6.39|0.87|0.093
72577820|NCT01753297|144682880|OTHER||Hazard Ratio (HR)|2.03||||0.168|TWO_SIDED|95.0|0.74|5.55|||Regression, Cox|||"Comparison between Gleason score categories: Gleason score of ≥8 compared to Gleason score ≤6.~A Cox proportional hazard model was fitted to compute HRs and the corresponding 95% CIs with treatment group, country (China as reference), centre (the largest centre as reference), and Gleason score on prostatectomy specimen (in categories: ≤6 / =7 / ≥8, with ≤6 considered as the reference) as fixed factors."||5.55|0.74|0.168
72577821|NCT01753297|144682882|OTHER|||||||0.639|||||||Log Rank|||A two-sided log-rank test was used to compare time to EFS between both treatment groups.|Analysis was based on 2 EFS events in the active surveillance arm and 3 EFS events in the triptorelin arm.|||0.639
72577822|NCT01753297|144682882|OTHER||Hazard Ratio (HR)|1.52||||0.653|TWO_SIDED|95.0|0.24|9.59|||Regression, Cox|||"Comparison between treatment groups: Triptorelin compared to Active surveillance.~A Cox proportional hazard model was fitted to compute HRs and the corresponding 95% CIs with treatment group, country (China as reference), centre (the largest centre as reference), and Gleason score on prostatectomy specimen (in categories: ≤6 / =7 / ≥8, with ≤6 considered as the reference) as fixed factors."||9.59|0.24|0.653
72577823|NCT01753297|144682882|OTHER|||||||0.999|||||||Regression, Cox|||"Country effect.~A Cox proportional hazard model was fitted to compute HRs and the corresponding 95% CIs with treatment group, country (China as reference), centre (the largest centre as reference), and Gleason score on prostatectomy specimen (in categories: ≤6 / =7 / ≥8, with ≤6 considered as the reference) as fixed factors."||||0.999
72577824|NCT01753297|144682882|OTHER|||||||1|||||||Regression, Cox|||"Centre effect.~A Cox proportional hazard model was fitted to compute HRs and the corresponding 95% CIs with treatment group, country (China as reference), centre (the largest centre as reference), and Gleason score on prostatectomy specimen (in categories: ≤6 / =7 / ≥8, with ≤6 considered as the reference) as fixed factors."||||1.000
72543125|NCT00185211|144616546|SUPERIORITY_OR_OTHER|||||||0.8245||95.0||||The two-sided error level for the exploratory analysis of the secondary outcome measures was of 0.05.|ANCOVA|Variable used as covariate: MSFC Z-scores measured at baseline||"The null hypothesis H0: The mean MSFC Z-scores at month 60 adjusted for baseline MSFC Z-score are identical for both treatment arms was tested against the alternative hypothesis HA: The mean MSFC Z-scores at month 60 adjusted for baseline MSFC Z-score are not the same in the two treatment groups based on a non-parametric analysis of covariance (ANCOVA)."||||0.8245
72543126|NCT00185211|144616547|SUPERIORITY_OR_OTHER|||||||0.0062||95.0||||The two-sided error level for the exploratory analysis of the secondary outcome measures was of 0.05.|non-parametric ANCOVA|Variable used as covariate: number of Gd-enhancing lesions on T1 at screening||"The null hypothesis H0: The distribution of the cumulative number of newly active lesions at month 60 adjusted for the number of Gadolinium (Gd)-enhancing lesions on T1 at screening is identical for both treatment arms. was tested against the corresponding two-sided alternative hypothesis based on a non-parametric analysis of covariance (ANCOVA)."||||0.0062
72543127|NCT00185211|144616547|SUPERIORITY_OR_OTHER||Relative effect size|0.7351||||0.0435||95.0|0.5436|0.994||The two-sided error level for the exploratory analysis of the secondary outcome measures was of 0.05.|generalized linear model|Distribution: negative binomial distribution; covariate: number of Gd-enhancing lesions on T1 at screening|The direction of comparison is initial IFNB-1b versus initial placebo.|Assuming that the cumulative number of newly active lesions at month 60 follows a negative binomial distribution, a generalized linear model (logarithmic link function, covariate: number of Gd-enhancing lesions on T1 at BENEFIT screening) was set up in order to analyze the treatment effect on that MRI outcome.||0.9940|0.5436|0.0435
72543128|NCT00185211|144616548|SUPERIORITY_OR_OTHER|||||||0.7801||95.0||||The two-sided error level for the exploratory analysis of the secondary outcome measures was of 0.05.|non-parametric ANCOVA|Variable used as covariate: T2 lesion volume at screening||"The null hypothesis H0: The distribution of the absolute change of T2 lesion volume at month 60 adjusted for the T2 lesion volume at screening is identical for both treatment arms. was tested against the corresponding two-sided alternative hypothesis based on a non-parametric analysis of covariance (ANCOVA)."||||0.7801
72543129|NCT00185211|144616548|SUPERIORITY_OR_OTHER|||||||0.9408||95.0||||The two-sided error level for the exploratory analysis of the secondary outcome measures was of 0.05.|ANCOVA|Variable used as covariate: T2 lesion volume at screening||"The null hypothesis H0: The mean absolute change of T2 lesion volume at month 60 adjusted for the T2 lesion volume at screening is identical for both treatment arms. was tested against the corresponding two-sided alternative hypothesis based on a parametric analysis of covariance (ANCOVA)."||||0.9408
72543130|NCT00185211|144616549|SUPERIORITY_OR_OTHER|||||||0.6619||95.0||||The two-sided error level for the exploratory analysis of the secondary outcome measures was of 0.05.|non-parametric ANCOVA|Variable used as covariate: Volume of black holes at screening||"The null hypothesis H0: The distribution of the absolute change of volume of black holes at month 60 adjusted for the volume of black holes at screening is identical for both treatment arms. was tested against the corresponding two-sided alternative hypothesis based on a non-parametric analysis of covariance (ANCOVA)."||||0.6619
72543131|NCT00185211|144616549|SUPERIORITY_OR_OTHER|||||||0.8558||95.0||||The two-sided error level for the exploratory analysis of the secondary outcome measures was of 0.05.|ANCOVA|Variable used as covariate: Volume of black holes at screening||"The null hypothesis H0: The mean absolute change of volume of black holes at month 60 adjusted for the volume of black holes at screening is identical for both treatment arms. was tested against the corresponding two-sided alternative hypothesis based on a parametric analysis of covariance (ANCOVA)."||||0.8558
72543132|NCT00185211|144616550|SUPERIORITY_OR_OTHER|||||||0.1208||95.0||||The two-sided error level for the exploratory analysis of the secondary outcome measures was of 0.05.|non-parametric ANCOVA|Variable used as covariate: Brain volume at screening||"The null hypothesis H0: The distribution of the percentage change of brain volume at month 60 adjusted for the brain volume at screening is identical for both treatment arms. was tested against the corresponding two-sided alternative hypothesis based on a non-parametric analysis of covariance (ANCOVA)."||||0.1208
72543133|NCT00185211|144616550|SUPERIORITY_OR_OTHER|||||||0.0719||95.0||||The two-sided error level for the exploratory analysis of the secondary outcome measures was of 0.05.|ANCOVA|Variable used as covariate: Brain volume at screening||"The null hypothesis H0: The mean percentage change of brain volume at month 60 adjusted for the brain volume at screening is identical for both treatment arms. was tested against the corresponding two-sided alternative hypothesis based on a parametric analysis of covariance (ANCOVA)."||||0.0719
72543134|NCT02544633|144616551|SUPERIORITY|An exact test for single proportion (two-sided a=5%) will be performed to test H0: ORR \<=20% against H1: ORR \>20%.|Objective response rate|10.7||||0.94|TWO_SIDED|95.0|2.27|28.23|||exact test|||||28.23|2.27|0.94
72543135|NCT02544633|144616551|SUPERIORITY||Objective response rate|15.0||||0.79|TWO_SIDED|95.0|3.21|37.89|||exact test|||||37.89|3.21|0.79
72543136|NCT02544633|144616551|SUPERIORITY||Objective response rate|25.0||||0.47|TWO_SIDED|95.0|3.19|65.09|||Exact Test|||||65.09|3.19|0.47
72543137|NCT02544633|144616551|SUPERIORITY||Objective response rate|0.0|||>|0.999|TWO_SIDED|95.0|0.0|26.46|||Exact test|||||26.46|0.00|>0.999
72543138|NCT02257632|144616575|SUPERIORITY||Mean Difference (Final Values)|-14.98|||<|0.0001|TWO_SIDED|95.0|-19.64|-10.32||missing Baseline VEGF-A level covariate values were imputed by the mean value of non-missing Baseline VEGF-A level from all other patients|ANCOVA|including treatment group and center as fixed effect factors and Baseline VEGF-A as a covariate||||-10.32|-19.64|<0.0001
72543139|NCT02257632|144616576|SUPERIORITY||Mean Difference (Final Values)|-11.46|||<|0.0001|TWO_SIDED|95.0|-15.98|-6.94||missing Baseline VEGF-A level covariate values were imputed by the mean value of non-missing Baseline VEGF-A level from all the patients with values|ANCOVA|including treatment group and center as fixed effect factors and Baseline VEGF-A as a covariate||||-6.94|-15.98|< 0.0001
72329454|NCT03037476|144184382|OTHER|General Linear Model|Slope|0.149||||0.446|TWO_SIDED|95.0|-0.234|0.531|||Mixed Models Analysis|Poisson Regression||Change in Past 3 Month Stimulant Use from Baseline to 6 Month Followup||.531|-.234|.446
72421525|NCT01342458|144354201|SUPERIORITY_OR_OTHER||Effect size|0.71|||<|0.001|TWO_SIDED||||||post hoc Newman-Keuls|||From baseline to 3rd month.||||<0.001
72421526|NCT01342458|144354201|SUPERIORITY_OR_OTHER||Effect size|0.45|||<|0.001|TWO_SIDED||||||post hoc Newman-Keuls|||From baseline to 6th month.||||<0.001
72577825|NCT01753297|144682882|OTHER|||||||0.583|||||||Regression, Cox|||"Gleason score effect.~A Cox proportional hazard model was fitted to compute HRs and the corresponding 95% CIs with treatment group, country (China as reference), centre (the largest centre as reference), and Gleason score on prostatectomy specimen (in categories: ≤6 / =7 / ≥8, with ≤6 considered as the reference) as fixed factors."||||0.583
72577826|NCT01753297|144682884|OTHER|||||||0.557|||||||Log Rank|||A two-sided log-rank test was used to compare time to OS between both treatment groups.|1 death occurred in the active surveillance arm and 2 deaths occurred in the triptorelin arm.|||0.557
72577827|NCT01753297|144682887|OTHER|||||||0.525|||||||Log Rank|||A two-sided log-rank test was used to compare PSADT between both treatment groups.|Analysis was based on 9 PSADT events in the active surveillance arm and 6 PSADT events in the triptorelin arm.|||0.525
72577828|NCT01753297|144682887|OTHER||Hazard Ratio (HR)|1.72||||0.435|TWO_SIDED|95.0|0.44|6.73|||Regression, Cox|||"Comparison between treatment groups: Triptorelin compared to Active surveillance.~A Cox proportional hazard model was fitted to compute HRs and the corresponding 95% CIs with treatment group, country (China as reference), centre (the largest centre as reference), and Gleason score on prostatectomy specimen (in categories: ≤6 / =7 / ≥8, with ≤6 considered as the reference) as fixed factors."||6.73|0.44|0.435
72577829|NCT01753297|144682887|OTHER|||||||0.761|||||||Regression, Cox|||"Country effect.~A Cox proportional hazard model was fitted to compute HRs and the corresponding 95% CIs with treatment group, country (China as reference), centre (the largest centre as reference), and Gleason score on prostatectomy specimen (in categories: ≤6 / =7 / ≥8, with ≤6 considered as the reference) as fixed factors."||||0.761
72577830|NCT01753297|144682887|OTHER|||||||0.652|||||||Regression, Cox|||"Centre effect.~A Cox proportional hazard model was fitted to compute HRs and the corresponding 95% CIs with treatment group, country (China as reference), centre (the largest centre as reference), and Gleason score on prostatectomy specimen (in categories: ≤6 / =7 / ≥8, with ≤6 considered as the reference) as fixed factors."||||0.652
72577831|NCT01753297|144682887|OTHER|||||||0.726|||||||Regression, Cox|||"Gleason score effect.~A Cox proportional hazard model was fitted to compute HRs and the corresponding 95% CIs with treatment group, country (China as reference), centre (the largest centre as reference), and Gleason score on prostatectomy specimen (in categories: ≤6 / =7 / ≥8, with ≤6 considered as the reference) as fixed factors."||||0.726
72577832|NCT00230178|144682893|SUPERIORITY_OR_OTHER||Difference in response rate %|21.0||||0.0009||95.0|8.6|32.7|||Wilson's method|||||32.7|8.6|0.0009
72577833|NCT00230178|144682893|SUPERIORITY_OR_OTHER||Difference in response rate %|12.3||||0.0632||95.0|-0.9|25.0|||Wilson's method|||||25.0|-0.9|0.0632
72577834|NCT00230178|144682894|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANOVA|||||||<0.0001
72577835|NCT00230178|144682894|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANOVA|||||||<0.0001
72577836|NCT03577301|144682896|SUPERIORITY||Wald Chi Square|3.3||||0.35|TWO_SIDED||||||Negative Binomial Regression|Model testing whether condition predicted illicit drug use at 3 months.||||||0.35
72577837|NCT03577301|144682896|SUPERIORITY||Wald Chi Square|1.97||||0.58|TWO_SIDED||||||Negative Binomial Regression|Model testing whether condition predicted illicit drug use at 6 months.||||||0.58
72577838|NCT03577301|144682896|SUPERIORITY||Wald Chi Square|1.68||||0.64|TWO_SIDED||||||Negative Binomial Regression|Model testing whether condition predicted illicit drug use at 9 months.||||||0.64
72577839|NCT03577301|144682896|SUPERIORITY||Wald Chi Square|1.15||||0.76|TWO_SIDED||||||Negative Binomial Regression|Model testing whether condition predicted illicit drug use at 12 months.||||||0.76
72543140|NCT00936884|144616598|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|83.6|||<|0.0001|TWO_SIDED|97.5|6.5|1074.7||Comparison of the MNTX group and the placebo group in the proportion of subjects having a RFBM within 4 hours after the first injection was performed by using a 2-sided Cochran-Mantel-Haenszel Chi square test at the alpha level of 0.025.|Chi-squared|||||1074.7|6.50|<0.0001
72543141|NCT00936884|144616599|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|56.64|||<|0.0001|TWO_SIDED|97.5|40.62|72.66||Comparison of the MNTX group and the placebo group was based on ANOVA model with the proportion of injections resulting in RFBM within 4 hours during the double-blind period as the dependent variable and the treatment group as the fixed effect. .|ANOVA||Estimated value is the difference in least squared means for MNTX vs. placebo (MNTX minus placebo). Based on the ANOVA model, there is 97.5% confidence that the difference between MNTX and placebo falls between the lower and upper limits presented.|||72.66|40.62|<0.0001
72543142|NCT00936884|144616600|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|23.38|||<|0.0001|TWO_SIDED|97.5|10.91|50.14||Comparison of the MNTX group and the placebo group in the proportion of subjects having a RFBM within 4 hours after each injection was performed by using a 2-sided Cochran-Mantel-Haenszel Chi square test at the alpha level of 0.025.|Chi-squared|||||50.14|10.91|< 0.0001
72543143|NCT01859390|144616634|SUPERIORITY||Mean Difference (Final Values)|-0.13||||0.46|TWO_SIDED|95.0|-0.49|0.22|||t-test, 2 sided|||Two-sample T-test||0.22|-0.49|0.460
72577840|NCT03577301|144682897|SUPERIORITY||Wald Chi Square|3.08||||0.38|TWO_SIDED||||||Negative Binomial Regression|Model testing whether condition predicted condomless anal sex acts at 3 months.||||||0.38
72577841|NCT03577301|144682897|SUPERIORITY||Wald Chi Square|1.26||||0.74|TWO_SIDED||||||Negative Binomial Regression|Model testing whether condition predicted condomless anal sex acts at 6 months.||||||0.74
72577842|NCT03577301|144682897|SUPERIORITY||Wald Chi Square|1.27||||0.74|TWO_SIDED||||||Negative Binomial Regression|Model testing whether condition predicted condomless anal sex acts at 9 months.||||||0.74
72577843|NCT03577301|144682897|SUPERIORITY||Slope|3.66||||0.3|TWO_SIDED||||||Negative Binomial Regression|Model testing whether condition predicted condomless anal sex acts at 12 months.||||||0.300
72577844|NCT03577301|144682898|SUPERIORITY||Wald Chi Square|1.3||||0.73|TWO_SIDED||||||Negative Binomial Regression|Model testing whether condition predicted marijuana use days at 3 months.||||||0.73
72577845|NCT03577301|144682898|SUPERIORITY||Wald Chi Square|1.68||||0.64|TWO_SIDED||||||Negative Binomial Regression|Model testing whether condition predicted marijuana use days at 6 months.||||||0.64
72577846|NCT03577301|144682898|SUPERIORITY||Wald Chi Square|0.64||||0.89|TWO_SIDED||||||Negative Binomial Regression|Model testing whether condition predicted marijuana use days at 9 months.||||||0.89
72577847|NCT03577301|144682898|SUPERIORITY||Wald Chi Square|1.08||||0.78|TWO_SIDED||||||Negative Binomial Regression|Model testing whether condition predicted marijuana use days at 12 months.||||||0.78
72577848|NCT03577301|144682899|SUPERIORITY||Wald Chi Square|2.37||||0.5|TWO_SIDED||||||Negative Binomial Regression|Model testing whether condition predicted alcohol use days at 3 months.||||||0.50
72577849|NCT03577301|144682899|SUPERIORITY||Wald Chi Square|2.98||||0.34|TWO_SIDED||||||Negative Binomial Regression|Model testing whether condition predicted alcohol use days at 6 months.||||||0.34
72543144|NCT01859390|144616634|SUPERIORITY||Mean Difference (Final Values)|-0.17||||0.325|TWO_SIDED|95.0|-0.513|0.173|||Regression, Linear||"Regression Model predictors include: AquADEKs-2 arm, Age \>=18 years, Sex, Screening FEV1%Predicted \>70%, Chronic use of Inhaled Antibiotics and Azithromycin.~The estimated value is the mean difference between groups for 16 week change in log10 MPO."|||0.173|-0.513|0.325
72543145|NCT01859390|144616635|SUPERIORITY||Difference in Proportions-SAE incidence|-12.9||||0.302|TWO_SIDED|95.0|-32.1|7.8|||Fisher Exact|||||7.8|-32.1|0.302
72577850|NCT03577301|144682899|SUPERIORITY||Wald Chi Square|1.59||||0.66|TWO_SIDED||||||Negative Binomial Regression|Model testing whether condition predicted alcohol use days at 9 months.||||||0.66
72577851|NCT03577301|144682899|SUPERIORITY||Wald Chi Square|2.74||||0.43|TWO_SIDED||||||Negative Binomial Regression|Model testing whether condition predicted alcohol use days at 12 months.||||||0.43
72577852|NCT01931878|144682900|SUPERIORITY_OR_OTHER|||||||0.031|TWO_SIDED||||||t-test, 2 sided|||comparison of mean RLS Scale scores between 21 incoA and 21 saline injections||||0.031
72577853|NCT01931878|144682901|SUPERIORITY_OR_OTHER|||||||0.0088|TWO_SIDED||||||Fisher Exact|||||||0.0088
72577854|NCT01931878|144682902|SUPERIORITY_OR_OTHER|||||||0.0855|TWO_SIDED||||||Fisher Exact|||||||0.0855
72577855|NCT04315506|144682940|SUPERIORITY||Odds Ratio (OR)|1.14||||0.5384|TWO_SIDED|95.0|0.75|1.72||The analysis was a two-intervention arm comparison. Adjustments for multiple tests and outcomes were not required.|Regression, Logistic||Odds of quitting in Enuf Snuff group (SGR) compared to Enough Snuff (control)|||1.72|0.75|0.5384
72577856|NCT04315506|144682941|SUPERIORITY||Slope|-0.1057||||0.6624|TWO_SIDED|95.0|-0.5808|0.3693||P-value above is for the treatment-by-time squared term in the statistical model for longitudinal data; quadratic change in outcome determined, compared trajectory of outcome change in EnufSnuff (SGR) compared to Enough Snuff (control)|Mixed Models Analysis|Multi-level, mixed-effects model for longitudinal data was conducted.|Slope difference estimate reported above, estimate compares trajectory slope coefficient for EnufSnuff (SGR) to slope coefficient for Enough Snuff (control).|For secondary outcomes, the study was not powered. The null hypothesis was no between-treatment arm difference in the trajectory of change from baseline to six months.||0.3693|-0.5808|0.6624
72577857|NCT04315506|144682942|SUPERIORITY||Slope|0.0946||||0.232|TWO_SIDED|95.0|-0.0609|0.2501||A multi-level, mixed-effects model for longitudinal data was applied. The p-value provided above was for the treatment-by-time effect used to test for differences in the trajectory of change in craving reduction between the two treatment groups.|Mixed Models Analysis|Multi-level, mixed-effects model for longitudinal data was conducted. (trajectory analysis)|Slope difference estimate reported above, estimate compares trajectory slope coefficient for EnufSnuff (SGR) to slope coefficient for Enough Snuff (control).|For secondary outcomes, the study was not powered. The null hypothesis was no between-treatment arm difference in the trajectory of change from baseline to six months.||0.2501|-0.0609|0.2320
72543146|NCT01859390|144616636|SUPERIORITY||Rate Ratio|0.94||||0.486|TWO_SIDED|95.0|0.78|1.13|||Poisson Model|||Rate Ratio for Adverse Events calculated using Poisson Regression with an offset for the log of follow-up time in weeks. The total number of follow-up weeks in the AquADEKs-2 group was 642 and in the Control group was 639.||1.13|0.78|0.486
72543147|NCT01859390|144616636|SUPERIORITY|Rate Ratio for Serious Adverse Events calculated using Poisson Regression with an offset for the log of follow-up time in weeks. The total number of follow-up weeks in the AquADEKs-2 group was 642 and in the Control group was 639.|Rate Ratio|0.74||||0.269|TWO_SIDED|95.0|0.43|1.26|||Poisson Regression|||||1.26|0.43|0.269
72543148|NCT01859390|144616637|SUPERIORITY|Two sample T-test|Median Difference (Final Values)|1.43||||0.4463|TWO_SIDED|95.0|-2.3|5.16|||t-test, 2 sided|||||5.16|-2.30|0.4463
72543149|NCT01859390|144616638|SUPERIORITY||Median Difference (Final Values)|0.04||||0.8623|TWO_SIDED|95.0|-0.37|0.44|||t-test, 2 sided|||||0.44|-0.37|0.8623
72543150|NCT01859390|144616639|SUPERIORITY||Cox Proportional Hazard|0.536||||0.0534|TWO_SIDED|95.0|0.284|1.009||Not adjusted for multiple comparisons. Alpha at 0.05.|Regression, Cox||"Cox model parameters include: AquADEKs-2 arm, Age \>=18 years, Sex, Screening FEV1 % Predicted \>70%, Chronic use of Inhaled Antibiotics and Azithromycin.~The parameter of interest is the Hazard Ratio comparing the AquADEKs-2 arm to the control arm."|||1.009|0.284|0.0534
72543151|NCT01859390|144616640|SUPERIORITY||Rate Ratio|0.72||||0.1731|TWO_SIDED|95.0|0.44|1.16|||Poisson Model|||Rate Ratio for PEx calculated using Poisson Regression with an offset for the log of follow-up time in months. The total number of follow-up months in the AquADEKs-2 group was 148 and in the Control group was 147.||1.16|0.44|0.1731
72543152|NCT01859390|144616641|SUPERIORITY|Difference in Proportions|Mean Difference (Final Values)|-14.8||||0.2363|TWO_SIDED|95.0|-35.1|7.4||Not adjusted for multiple comparisons. Alpha at 0.05.|Fisher Exact|||||7.4|-35.1|0.2363
72543153|NCT01859390|144616642|SUPERIORITY|Difference in Proportions|Median Difference (Final Values)|-15.7||||0.19|TWO_SIDED|95.0|-34.5|4.8|||Fisher Exact|||||4.8|-34.5|0.1900
72543154|NCT01706198|144616670|OTHER||Adjusted Odds Ratio|2.0|||<|0.001|TWO_SIDED|95.0|1.7|2.34||The analysis method was logistic regression adjusted for randomized treatment, asthma maintenance therapy (AMT) at Baseline per randomization stratification, Baseline ACT total score, Baseline ACT total score squared, gender and age.|Regression, Logistic||Adjusted odds ratio comparing FF/VI with Usual Care has been presented.|||2.34|1.70|<0.001
72543155|NCT01706198|144616671|OTHER||Adjusted Odds Ratio|1.92|||<|0.001|TWO_SIDED|95.0|1.67|2.2||Logistic regression adjusted for randomized treatment, AMT at Baseline per randomization stratification, Baseline ACT total score, Baseline ACT total score squared, gender and age.|Regression, Logistic||Adjusted odds ratio comparing FF/VI with Usual Care for Week 12 has been presented.|||2.20|1.67|<0.001
72543156|NCT01706198|144616671|OTHER||Adjusted Odds Ratio|1.66|||<|0.001|TWO_SIDED|95.0|1.45|1.91||Logistic regression adjusted for randomized treatment, AMT at Baseline per randomization stratification, Baseline ACT total score, Baseline ACT total score squared, gender and age.|Regression, Logistic||Adjusted odds ratio comparing FF/VI with Usual Care for Week 40 has been presented.|||1.91|1.45|<0.001
72543157|NCT01706198|144616671|OTHER||Adjusted Odds Ratio|1.76|||<|0.001|TWO_SIDED|95.0|1.54|2.02||Logistic regression adjusted for randomized treatment, AMT at Baseline per randomization stratification, Baseline ACT total score, Baseline ACT total score squared, gender and age.|Regression, Logistic||Adjusted odds ratio comparing FF/VI with Usual Care for Week 52 has been presented.|||2.02|1.54|<0.001
72543158|NCT01706198|144616672|OTHER||Adjusted Odds Ratio|2.09|||<|0.001|TWO_SIDED|95.0|1.82|2.4||The analysis method was logistic regression adjusted for randomized treatment, AMT at Baseline per randomization stratification, Baseline ACT total score, gender and age.|Regression, Logistic||Adjusted odds ratio comparing FF/VI with Usual Care at Week 12 has been presented.|||2.40|1.82|<0.001
72543159|NCT01706198|144616672|OTHER||Adjusted Odds Ratio|1.96|||<|0.001|TWO_SIDED|95.0|1.7|2.25||The analysis method was logistic regression adjusted for randomized treatment, AMT at Baseline per randomization stratification, Baseline ACT total score, gender and age.|Regression, Logistic||Adjusted odds ratio comparing FF/VI with Usual Care at Week 24 has been presented.|||2.25|1.70|<0.001
72543160|NCT01706198|144616672|OTHER||Adjusted Odds Ratio|1.79|||<|0.001|TWO_SIDED|95.0|1.56|2.06||The analysis method was logistic regression adjusted for randomized treatment, AMT at Baseline per randomization stratification, Baseline ACT total score, gender and age.|Regression, Logistic||Adjusted odds ratio comparing FF/VI with Usual Care at Week 40 has been presented.|||2.06|1.56|<0.001
72543161|NCT01706198|144616672|OTHER||Adjusted Odds Ratio|1.95|||<|0.001|TWO_SIDED|95.0|1.69|2.24||The analysis method was logistic regression adjusted for randomized treatment, AMT at Baseline per randomization stratification, Baseline ACT total score, gender and age.|Regression, Logistic||Adjusted odds ratio comparing FF/VI with Usual Care at Week 52 has been presented.|||2.24|1.69|<0.001
72543162|NCT01706198|144616673|OTHER||Adjusted Odds Ratio|2.28|||<|0.001|TWO_SIDED|95.0|1.98|2.62||The analysis method was logistic regression adjusted for randomized treatment, AMT at Baseline per randomization stratification, Baseline ACT total score, gender and age.|Regression, Logistic||Adjusted odds ratio comparing FF/VI with Usual Care at Week 12 has been presented.|||2.62|1.98|<0.001
72543163|NCT01706198|144616673|OTHER||Adjusted Odds Ratio|2.09|||<|0.001|TWO_SIDED|95.0|1.81|2.41||The analysis method was logistic regression adjusted for randomized treatment, AMT at Baseline per randomization stratification, Baseline ACT total score, gender and age.|Regression, Logistic||Adjusted odds ratio comparing FF/VI with Usual Care at Week 24 has been presented.|||2.41|1.81|<0.001
72543164|NCT01706198|144616673|OTHER||Adjusted Odds Ratio|1.76|||<|0.001|TWO_SIDED|95.0|1.53|2.02||The analysis method was logistic regression adjusted for randomized treatment, AMT at Baseline per randomization stratification, Baseline ACT total score, gender and age.|Regression, Logistic||Adjusted odds ratio comparing FF/VI with Usual Care at Week 40 has been presented.|||2.02|1.53|<0.001
72543165|NCT01706198|144616673|OTHER||Adjusted Odds Ratio|1.91|||<|0.001|TWO_SIDED|95.0|1.66|2.21||The analysis method was logistic regression adjusted for randomized treatment, AMT at Baseline per randomization stratification, Baseline ACT total score, gender and age.|Regression, Logistic||Adjusted odds ratio comparing FF/VI with Usual Care at Week 52 has been presented.|||2.21|1.66|<0.001
72410898|NCT04382326|144330119|NON_INFERIORITY|Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR of 20vPnC group to 13vPnC group is greater than 0.5 (2-fold NI margin).|Geometric Mean Ratios|1.23|||||TWO_SIDED|95.0|1.02|1.48||||||Rubella: GMR and 2-Sided CI were calculated by exponentiating the mean difference (20vPnC - 13vPnC) of the logarithms of the concentrations and the corresponding CI (based on the Student's t distribution).||1.48|1.02|
72410899|NCT04382326|144330120|NON_INFERIORITY|Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR of 20vPnC group to 13vPnC group is greater than 0.5 (2-fold NI margin).|Geometric Mean Ratios|0.99|||||TWO_SIDED|95.0|0.84|1.17||||||Varicella: GMR and 2-Sided CI were calculated by exponentiating the mean difference (20vPnC - 13vPnC) of the logarithms of the concentrations and the corresponding CI (based on the Student's t distribution)||1.17|0.84|
72410900|NCT03017508|144330121|SUPERIORITY||Mean Difference (Final Values)|-8.34|STANDARD_DEVIATION|18.34||0.056|TWO_SIDED||||||t-test, 2 sided|||Paired t-test on VAS scores during speech comparing sublingual riluzole to placebo||||0.056
72410901|NCT02114892|144330189|SUPERIORITY_OR_OTHER_LEGACY|||||||0.131|||||||Wilcoxon (Mann-Whitney)|||||||0.131
72410902|NCT02114892|144330190|SUPERIORITY_OR_OTHER_LEGACY|||||||0.859|||||||Wilcoxon (Mann-Whitney)|||||||0.859
72543166|NCT01706198|144616674|OTHER||Mean Difference (Net)|1.54|||<|0.001|TWO_SIDED|95.0|1.3|1.77||MMRM adjusted for randomized treatment, AMT at Baseline per randomization stratification, Baseline ACT total score, randomized treatment-by-Baseline ACT total score interaction, gender, age, visit and randomized treatment by visit interaction.|Mixed Model Repeated Measures (MMRM)||Treatment difference of FF/VI versus Usual Care at Week 12 has been presented.|||1.77|1.30|<0.001
72543167|NCT01706198|144616674|OTHER||Mean Difference (Net)|1.5|||<|0.001|TWO_SIDED|95.0|1.25|1.76||MMRM adjusted for randomized treatment, AMT at Baseline per randomization stratification, Baseline ACT total score, randomized treatment-by-Baseline ACT total score interaction, gender, age, visit and randomized treatment by visit interaction.|MMRM||Treatment difference of FF/VI versus Usual Care at Week 24 has been presented.|||1.76|1.25|<0.001
72410903|NCT02114892|144330191|SUPERIORITY_OR_OTHER_LEGACY|||||||0.07|||||||Wilcoxon (Mann-Whitney)|||||||0.070
72410904|NCT02114892|144330192|SUPERIORITY_OR_OTHER_LEGACY|||||||0.338|||||||Wilcoxon (Mann-Whitney)|||||||0.338
72410905|NCT02114892|144330193|SUPERIORITY_OR_OTHER_LEGACY|||||||0.278|||||||Wilcoxon (Mann-Whitney)|||||||0.278
72410906|NCT02114892|144330194|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||||||<0.01
72410907|NCT02114892|144330195|SUPERIORITY_OR_OTHER_LEGACY|||||||0.083|||||||Wilcoxon (Mann-Whitney)|||||||0.083
72410908|NCT02114892|144330196|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||||||<0.01
72410909|NCT02114892|144330197|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||||||<0.01
72410910|NCT02114892|144330198|SUPERIORITY_OR_OTHER_LEGACY|||||||0.946|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.946
72410911|NCT02114892|144330199|SUPERIORITY_OR_OTHER_LEGACY|||||||0.365|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.365
72410912|NCT02114892|144330200|SUPERIORITY_OR_OTHER_LEGACY|||||||0.557|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.557
72410913|NCT02114892|144330201|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.01|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<0.01
72410914|NCT02114892|144330202|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.01|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<0.01
72410915|NCT02114892|144330203|SUPERIORITY_OR_OTHER_LEGACY|||||||0.672|||||||Wilcoxon (Mann-Whitney)|||||||0.672
72410916|NCT02753751|144330204|SUPERIORITY|The Mantel-Haenszel test was used, accounting for each hospital as an individual stratum, and to obtain the pooled relative risks across hospitals without adjusting for other baseline factors. (Alert arm is the numerator, control arm is the denominator.) Patients discharged prior to 14 days without an outcome of interest were assumed to be free of that outcome at 14 days. A p-value of \<=0.04 was considered statistically significant to account for the interim analysis.|Risk Ratio (RR)|1.02||||0.67|TWO_SIDED|95.0|0.93|1.13||A p-value of \<=0.04 was considered statistically significant to account for the interim analysis.|Cochran-Mantel-Haenszel|||In our retrospective analysis of patients with AKI at 3 potential study hospitals, the composite outcome was 24.5%. A clinically meaningful relative reduction in this risk would be 20%. 5,024 patients (2,512 in each group) would have 90% power to detect a difference in outcome at least this extreme at a two-sided alpha of 0.05 as calculated using the Cochran-Mantel-Haenszel test. We have elected to increase this number by 20% to account for potential contamination.||1.13|0.93|0.67
72410917|NCT00718042|144330216|SUPERIORITY_OR_OTHER||Specificity|99.86|||||TWO_SIDED|95.0|99.79|99.91|||Point Estimate||Numerator = All blood donors tested nonreactive from all True Negative blood donors (16,223) Denominator = All True Negative blood donors (16,246) True Negative excludes donor specimens positive by supplemental testing (3)|||99.91|99.79|
72410918|NCT00718042|144330218|SUPERIORITY_OR_OTHER||Point estimate|100.0|||||TWO_SIDED|95.0|96.7|100.0|||Sensitivity|||||100.00|96.70|
72410919|NCT00718042|144330221|SUPERIORITY_OR_OTHER||Percentage|99.1|||||TWO_SIDED|95.0|97.4|99.8|||Percentage Negative|||||99.8|97.4|
72410920|NCT00614939|144330225|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.42|STANDARD_ERROR_OF_MEAN|0.151||0.007|TWO_SIDED|95.0|-0.71|-0.12|||ANCOVA|\*Adjusted for baseline HbA1c||||-0.12|-0.71|0.007
72410921|NCT00614939|144330226|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-12.34|STANDARD_ERROR_OF_MEAN|12.847||0.339||95.0|-37.91|13.22|||ANCOVA|\*Adjusted for baseline FPG||"Additional details about the analysis, such as null hypothesis and power calculation:~Due to a statistically significant treatment-by-baseline renal impairment interaction, fasting plasma glucose results were analyzed separately for each baseline renal impairment category."||13.22|-37.91|0.339
72410922|NCT00614939|144330227|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.36|STANDARD_ERROR_OF_MEAN|16.938||0.798|TWO_SIDED|95.0|-38.65|29.93|||ANCOVA|\*Adjusted for baseline FPG||"Additional details about the analysis, such as null hypothesis and power calculation:~Due to a statistically significant treatment-by-baseline renal impairment interaction, fasting plasma glucose results were analyzed separately for each baseline renal impairment category."||29.93|-38.65|0.798
72410923|NCT00614939|144330228|SUPERIORITY_OR_OTHER||Mean Difference (Net)|44.01|STANDARD_ERROR_OF_MEAN|30.815||0.164|TWO_SIDED|95.0|-18.93|106.94|||ANCOVA|\*Adjusted for baseline FPG||"Additional details about the analysis, such as null hypothesis and power calculation:~Due to a statistically significant treatment-by-baseline renal impairment interaction, fasting plasma glucose results were analyzed separately for each baseline renal impairment category."||106.94|-18.93|0.164
72410924|NCT00614939|144330229|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.68|STANDARD_ERROR_OF_MEAN|0.713|||TWO_SIDED|95.0|-2.1|0.74|||Footnote|\*Adjusted for baseline FPG||"Additional details about the analysis, such as null hypothesis and power calculation:~Due to a statistically significant treatment-by-baseline renal impairment interaction, fasting plasma glucose results were analyzed separately for each baseline renal impairment category."||0.74|-2.10|
72410925|NCT00614939|144330230|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.24|STANDARD_ERROR_OF_MEAN|0.941|||TWO_SIDED|95.0|-2.14|1.67|||Footnote|\*Adjusted for baseline FPG||"Additional details about the analysis, such as null hypothesis and power calculation:~Due to a statistically significant treatment-by-baseline renal impairment interaction, fasting plasma glucose results were analyzed separately for each baseline renal impairment category."||1.67|-2.14|
72410926|NCT00614939|144330231|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.44|STANDARD_ERROR_OF_MEAN|1.709|||TWO_SIDED|95.0|-1.05|5.93|||Footnote|\*Adjusted for baseline FPG||"Additional details about the analysis, such as null hypothesis and power calculation:~Due to a statistically significant treatment-by-baseline renal impairment interaction, fasting plasma glucose results were analyzed separately for each baseline renal impairment category."||5.93|-1.05|
72577858|NCT00919126|144682943|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|The analysis of covariance was adjusted for quantity of propofol (mg) administered during the induction period, gender, type of surgery and centre.||The dose of propofol adjusted to BSA and maintenance duration was expected to be 4.0 mg/m².min in the control group, 2.8 mg/m².min in one xenon group and 3.0 mg/m².min in the other xenon group. With an expected common standard deviation of 2.0 mg/m².min, a type I error of 0.05 (two-sided) and a power of 0.80, the sample size required to show a statistically significant difference between the three groups was estimated to be 48 patients per group, resulting in a total of 144 randomised patients.||||<0.0001
72577859|NCT00919126|144682943|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.0256|||<|0.0001|TWO_SIDED|95.0|2.328|3.724||Pairwise comparison performed using Tukey's test.|ANCOVA|The analysis of covariance was adjusted for quantity of propofol (mg) administered during the induction period, gender, type of surgery and centre.|The difference Xenon 70% in Oxygen minus Medical Air in Oxygen was assessed.|||3.724|2.328|<0.0001
72577860|NCT00919126|144682943|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.2905|||<|0.0001|TWO_SIDED|95.0|1.57|3.011||Pairwise comparison performed using Tukey's test.|ANCOVA|The analysis of covariance was adjusted for quantity of propofol (mg) administered during the induction period, gender, type of surgery and centre.|The difference Xenon 50% in Oxygen minus Medical Air in Oxygen was assessed.|||3.011|1.570|<0.0001
72577861|NCT00919126|144682943|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.7351||||0.0365|TWO_SIDED|95.0|0.038|1.432||Pairwise comparison was performed using the Tukey's test.|ANCOVA|The analysis of covariance was adjusted for quantity of propofol (mg) administered during the induction period, gender, type of surgery and centre.|The difference Xenon 70% in Oxygen minus Xenon 50% in Oxygen was assessed|||1.432|0.038|0.0365
72577862|NCT02032680|144682968|SUPERIORITY|||||||0.3749|||||||Cochran-Armitage Trend Test|||The two treatments were compared to see whether participants in one achieved a higher level on their goals (i.e., the maximum level achieved on the goal).||||0.3749
72577863|NCT03593395|144682973|OTHER|Estimation only|Least Square Mean Estimate|2.46|||||TWO_SIDED|95.0|1.81|3.34|||||Estimates are from generalized linear mixed model with a negative binomial distribution log link construct and length of follow up offset. Includes fixed effects for site size, baseline acute utilization, and random effect for cluster (site).|||3.34|1.81|
72410927|NCT00614939|144330232|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.82|STANDARD_ERROR_OF_MEAN|0.228|||TWO_SIDED|95.0|-1.27|-0.37|||Repeated Measures|"Number of subjects with observed values at Week 52 was n=26 for saxagliptin and n=34 for placebo~\*Adjusted for baseline HbA1c"||||-0.37|-1.27|
72410928|NCT00614939|144330233|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-17.98|STANDARD_ERROR_OF_MEAN|18.475|||TWO_SIDED|95.0|-54.28|18.33|||Repeated Measures|"Number of subjects with observed values at Week 52 was n=17 for saxagliptin and n=16 for placebo~\*Adjusted for baseline FPG"||"Additional details about the analysis, such as null hypothesis and power calculation:~Due to a statistically significant treatment-by-baseline renal impairment interaction, fasting plasma glucose results were analyzed separately for each baseline renal impairment category."||18.33|-54.28|
72410929|NCT00614939|144330234|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-15.73|STANDARD_ERROR_OF_MEAN|25.326|||TWO_SIDED|95.0|-65.77|34.3|||Repeated Measures|"Number of subjects with observed values at Week 52 was n=5 for saxagliptin and n=11 for placebo.~\*Adjusted for baseline FPG"||"Additional details about the analysis, such as null hypothesis and power calculation:~Due to a statistically significant treatment-by-baseline renal impairment interaction, fasting plasma glucose results were analyzed separately for each baseline renal impairment category."||34.30|-65.77|
72577864|NCT03593395|144682973|OTHER|Estimation only.|Least Square Mean Estimate|2.96|||||TWO_SIDED|95.0|2.09|4.19|||||Estimates are from generalized linear mixed model with a negative binomial distribution log link construct and length of follow up offset. Includes fixed effects for site size, baseline acute utilization, and random effect for cluster (site).|||4.19|2.09|
72577865|NCT00687830|144682997|SUPERIORITY_OR_OTHER||||||<|0.01||95.0|||||t-test, 2 sided|||||||<0.01
72577866|NCT00687830|144682998|SUPERIORITY_OR_OTHER|||||||0.04||95.0|||||Chi-squared|||||||0.04
72577867|NCT00606632|144683028|SUPERIORITY|||||||0.023|||||||McNemar|||||||0.023
72577868|NCT00606632|144683028|SUPERIORITY||||||<|0.01|||||||McNemar|||||||<0.01
72410930|NCT00614939|144330235|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-38.09|STANDARD_ERROR_OF_MEAN|53.822|||TWO_SIDED|95.0|-144.44|68.26|||Repeated Measures|"Number of subjects with observed values at Week 52 was n=2 for saxagliptin and n=5 for placebo.~\*Adjusted for baseline FPG"||"Additional details about the analysis, such as null hypothesis and power calculation:~Due to a statistically significant treatment-by-baseline renal impairment interaction, fasting plasma glucose results were analyzed separately for each baseline renal impairment category."||68.26|-144.44|
72410931|NCT00614939|144330236|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.97|STANDARD_ERROR_OF_MEAN|1.027|||TWO_SIDED|95.0|-2.99|1.04|||Repeated Measures|"Number of subjects with observed values at Week 52 was n=17 for saxagliptin and n=16 for placebo.~\*Adjusted for baseline FPG"||"Additional details about the analysis, such as null hypothesis and power calculation:~Due to a statistically significant treatment-by-baseline renal impairment interaction, fasting plasma glucose results were analyzed separately for each baseline renal impairment category."||1.04|-2.99|
72577869|NCT00711880|144683041|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-0.96||||0.004|TWO_SIDED|95.0|-1.59|-0.32|||ANCOVA|||The change in Numerical Rating Scale Peripheral Neuropathic Pain scores was compared between treatment groups using analysis of covariance (ANCOVA). The model included treatment and centre as factors and baseline Numerical Rating Scale Peripheral Neuropathic Pain score as a covariate.||-0.32|-1.59|0.004
72577870|NCT00711880|144683042|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-8.03||||0.007|TWO_SIDED|95.0|-13.83|-2.23|||ANCOVA|||The change in Neuropathic Pain Scale scores was compared between treatment groups using ANCOVA. The model included treatment and centre as factors and baseline Neuropathic Pain Scale score as a covariate.||-2.23|-13.83|0.007
72577871|NCT00711880|144683043|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-0.43||||0.001|TWO_SIDED|95.0|-0.67|-0.19|||ANCOVA|||The change in sleep disturbance scores was compared between treatment groups using ANCOVA. The model included treatment and centre as factors and mean baseline sleep disturbance score as a covariate.||-0.19|-0.67|0.001
72577872|NCT00711880|144683044|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-5.85||||0.003|TWO_SIDED|95.0|-9.62|-2.09|||ANCOVA|||The change in total Pain Disability Index scores was compared between treatment groups using ANCOVA. The model included treatment and centre as factors and mean baseline total Pain Disability Index score as a covariate.||-2.09|-9.62|0.003
72577873|NCT00711880|144683045|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-0.82||||0.042|TWO_SIDED|95.0|-1.6|-0.03|||ANCOVA|||The change in Dynamic Allodynia Test score was compared between treatment groups using ANCOVA. The model included treatment and centre as factors and mean baseline Dynamic Allodynia Test score as a covariate.||-0.03|-1.60|0.042
72577874|NCT00711880|144683046|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|12.73||||0.144|TWO_SIDED|95.0|-4.4|29.85|||ANCOVA|||The change in Static Allodynia Test score was compared between treatment groups using ANCOVA. The model included treatment and centre as factors and mean baseline Static Allodynia Test score as a covariate.||29.85|-4.40|0.144
72577875|NCT00711880|144683047|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-0.75||||0.483|TWO_SIDED|95.0|-2.84|1.35|||ANCOVA|||The change in total General Health Questionnaire score was compared between treatment groups using ANCOVA. The model included treatment and centre as factors and mean baseline total General Health Questionnaire score as a covariate.||1.35|-2.84|0.483
72577876|NCT00711880|144683048|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|0.02||||0.924|TWO_SIDED|95.0|-0.46|0.5|||ANCOVA|||The change in selective reminding test score was compared between treatment groups using ANCOVA. The model included treatment and centre as factors and mean baseline selective reminding test score as a covariate.||0.50|-0.46|0.924
72577877|NCT00711880|144683049|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|0.53||||0.214|TWO_SIDED|95.0|-0.31|1.38|||ANCOVA|||The change in 10/36 spatial recall test score was compared between treatment groups using ANCOVA. The model included treatment and centre as factors and mean baseline 10/36 spatial recall test score as a covariate.||1.38|-0.31|0.214
72577878|NCT00711880|144683050|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-2.15||||0.158|TWO_SIDED|95.0|-5.15|0.85|||ANCOVA|||The change in symbol digit modalities test score was compared between treatment groups using ANCOVA. The model included treatment and centre as factors and mean baseline symbol digit modalities test score as a covariate.||0.85|-5.15|0.158
72577879|NCT00711880|144683051|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|1.28||||0.656|TWO_SIDED|95.0|-4.47|7.04|||ANCOVA|||The change in paced auditory serial addition task score was compared between treatment groups using ANCOVA. The model included treatment and centre as factors and mean baseline paced auditory serial addition task test score as a covariate.||7.04|-4.47|0.656
72577880|NCT00711880|144683052|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-0.08||||0.962|TWO_SIDED|95.0|-3.56|3.39|||ANCOVA|||The change in word list generation test score was compared between treatment groups using ANCOVA. The model included treatment and centre as factors and mean baseline word list generation test score as a covariate.||3.39|-3.56|0.962
72577881|NCT00711880|144683053|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|32.26|||<|0.001|TWO_SIDED|95.0|16.4|48.12|||Fisher Exact|||The proportion of subjects who considered their condition 'Very Much Improved', 'Much Improved' or 'Minimally Improved' was compared between treatment groups for each question, using Fisher's Exact Test.||48.12|16.40|<0.001
72577882|NCT00711880|144683055|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|29.03||||0.001||95.0|13.39|44.67|||Fisher Exact|||The proportion of subjects who considered their condition 'Very Much Improved', 'Much Improved' or 'Minimally Improved' was compared between treatment groups for each question, using Fisher's Exact Test.||44.67|13.39|0.001
72577883|NCT04238650|144683060|EQUIVALENCE|Two treatments are judged not to be different from one another if the 90% CI of the ratio of a log-transformed exposure measure (AUC) falls completely within the range 0.80-1.25. The PK parameter AUC\[0-∞\] was log-transformed (base e) prior to analysis and was analysed using an ANCOVA model. The model included treatment as a fixed effect and body weight as a covariate.|Ratio of GLSM|1.04|||||TWO_SIDED|90.0|0.981|1.11||||||||1.11|0.981|
72410932|NCT00614939|144330237|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.89|STANDARD_ERROR_OF_MEAN|1.405|||TWO_SIDED|95.0|-3.66|1.89|||Repeated Measures|"Number of subjects with observed values at Week 52 was n=5 for saxagliptin and n=11 for placebo.~\*Adjusted for baseline FPG"||"Additional details about the analysis, such as null hypothesis and power calculation:~Due to a statistically significant treatment-by-baseline renal impairment interaction, fasting plasma glucose results were analyzed separately for each baseline renal impairment category."||1.89|-3.66|
72543168|NCT01706198|144616674|OTHER||Mean Difference (Net)|1.37|||<|0.001|TWO_SIDED|95.0|1.11|1.63||MMRM adjusted for randomized treatment, AMT at Baseline per randomization stratification, Baseline ACT total score, randomized treatment-by-Baseline ACT total score interaction, gender, age, visit and randomized treatment by visit interaction.|MMRM||Treatment difference of FF/VI versus Usual Care at Week 40 has been presented.|||1.63|1.11|<0.001
72543169|NCT01706198|144616674|OTHER||Mean Difference (Net)|1.5|||<|0.001|TWO_SIDED|95.0|1.24|1.76||MMRM adjusted for randomized treatment, AMT at Baseline per randomization stratification, Baseline ACT total score, randomized treatment-by-Baseline ACT total score interaction, gender, age, visit and randomized treatment by visit interaction.|MMRM||Treatment difference of FF/VI versus Usual Care at Week 52 has been presented.|||1.76|1.24|<0.001
72543170|NCT01706198|144616676|OTHER||Ratio|1.03||||0.786|TWO_SIDED|95.0|0.83|1.28||GLM assuming negative binomial distribution (NBD) adjusted for randomized treatment, asthma maintenance therapy at Baseline per randomization stratification, ACT total score at Baseline per randomization stratification, gender and age|Generalized Linear Model (GLM)||Ratio comparing FF/VI with Usual Care has been presented.|||1.28|0.83|0.786
72543171|NCT01706198|144616677|OTHER||Ratio|1.02||||0.461|TWO_SIDED|95.0|0.97|1.08||GLM assuming NBD adjusted for randomized treatment, asthma maintenance therapy at Baseline per randomization stratification, ACT total score at Baseline per randomization stratification, gender and age|Generalized Linear Model (GLM)||Ratio comparing FF/VI with Usual Care has been presented.|||1.08|0.97|0.461
72577884|NCT04238650|144683061|EQUIVALENCE|Two treatments are judged not to be different from one another if the 90% CI of the ratio of a log-transformed exposure measure (Cmax) falls completely within the range 0.80-1.25. The PK parameter Cmax was log-transformed (base e) prior to analysis and was analysed using an ANCOVA model. The model included treatment as a fixed effect and body weight as a covariate.|Ratio of GLSM|1.13|||||TWO_SIDED|90.0|1.03|1.24||||||||1.24|1.03|
72577885|NCT04238650|144683062|EQUIVALENCE|Two treatments are judged not to be different from one another if the 90% CI of the ratio of a log-transformed exposure measure (AUC) falls completely within the range 0.80-1.25. The PK parameter AUClast was log-transformed (base e) prior to analysis and was analysed using an ANCOVA model. The model included treatment as a fixed effect and body weight as a covariate.|Ratio of GLSM|1.05|||||TWO_SIDED|90.0|0.997|1.11||||||||1.11|0.997|
72577886|NCT03277066|144683069|SUPERIORITY||Lest-Squared Mean Differences|0.011||||0.011|TWO_SIDED||||||Mixed Models Analysis|||||||0.0110
72577887|NCT03277066|144683069|SUPERIORITY||Lest-Squared Mean Differences|0.2835||||0.2835|TWO_SIDED||||||Mixed Models Analysis|||||||0.2835
72577888|NCT02370238|144683079|SUPERIORITY||Hazard Ratio (HR)|1.14||||0.589|TWO_SIDED|95.0|0.71|1.81||p-value based on a log-rank test stratified by randomized sub-populations, newly diagnosed metastatic patients and patients that had relapsed following a prior (neo)adjuvant chemotherapy regimen.|Log Rank|||||1.81|0.71|0.589
72577889|NCT02370238|144683080|SUPERIORITY||Hazard Ratio (HR)|1.03||||0.897|TWO_SIDED|95.0|0.64|1.65||p-value based on a log-rank test stratified by randomized sub-populations, newly diagnosed metastatic patients and patients that had relapsed following a prior (neo)adjuvant chemotherapy regimen.|Log Rank|||||1.65|0.64|0.897
72577890|NCT02370238|144683081|SUPERIORITY||Odds Ratio (OR)|1.262||||0.667|TWO_SIDED|95.0|0.4909|3.963||P-value is based on Zelen's test for homogeneity of the odds ratios.|Zelen's test|||||3.963|0.4909|0.667
72577891|NCT02370238|144683083|SUPERIORITY|||||||0.767||||||For the All Patients group, p-value was based on a log-rank test stratified by actual sub-populations, newly diagnosed metastatic patients and patients that had relapsed following a prior (neo)adjuvant chemotherapy regimen.|Log Rank|||||||0.767
72577892|NCT02370238|144683084|SUPERIORITY||Odds Ratio (OR)|1.101||||0.667|TWO_SIDED|95.0|0.437|2.79||P-value was based on Zelen's test for homogeneity of the odds ratios|Zelen's test|||||2.790|0.437|0.667
72577893|NCT03417778|144683101|OTHER|If the upper bound of the 2-sided 90% CIs of the GLSM ratio for AUClast of filgotinib falls within the \[50%, 200%\] bound, the null hypothesis that participants with hepatic impairment exhibit AUClast change of at least 2-fold for filgotinib compared with participants with normal liver function will be rejected.|GLSM Ratio|161.14|||||TWO_SIDED|90.0|80.77|321.48||||||An analysis of variance (ANOVA) model was fitted to the natural logarithmic transformed values of the AUClast. Two-sided 90% confidence intervals (CI) were calculated for the geometric least-squares mean (GLSM) ratio of AUClast between hepatic impairment group versus the matched control (normal hepatic function) group.||321.48|80.77|
72577894|NCT03417778|144683102|OTHER|If the upper bound of the 2-sided 90% CIs of the GLSM ratio for AUClast of GS-829845 falls within the \[50%, 200%\] bound, the null hypothesis that participants with hepatic impairment exhibit AUClast change of at least 2-fold for GS-829845 compared with participants with normal liver function will be rejected.|GLSM Ratio|122.08|||||TWO_SIDED|90.0|69.67|213.89||||||An ANOVA model was fitted to the natural logarithmic transformed values of the AUClast. Two-sided 90% CI were calculated for the GLSM ratio of AUClast between hepatic impairment group versus the matched control (normal hepatic function) group.||213.89|69.67|
72577895|NCT03417778|144683103|OTHER|If the upper bound of the 2-sided 90% CIs of the GLSM ratio for AUCinf of filgotinib falls within the \[50%, 200%\] bound, the null hypothesis that participants with hepatic impairment exhibit AUCinf change of at least 2-fold for filgotinib compared with participants with normal liver function will be rejected.|GLSM Ratio|159.15|||||TWO_SIDED|90.0|82.22|308.06||||||An ANOVA model was fitted to the natural logarithmic transformed values of the AUCinf. Two-sided 90% CI were calculated for the GLSM ratio of AUCinf between hepatic impairment group versus the matched control (normal hepatic function) group.||308.06|82.22|
72577896|NCT03417778|144683104|OTHER|If the upper bound of the 2-sided 90% CIs of the GLSM ratio for AUCinf of GS-829845 falls within the \[50%, 200%\] bound, the null hypothesis that participants with hepatic impairment exhibit AUCinf change of at least 2-fold for GS-829845 compared with participants with normal liver function will be rejected.|GLSM Ratio|122.32|||||TWO_SIDED|90.0|69.9|214.07||||||An ANOVA model was fitted to the natural logarithmic transformed values of the AUCinf. Two-sided 90% CI were calculated for the GLSM ratio of AUCinf between hepatic impairment group versus the matched control (normal hepatic function) group.||214.07|69.90|
72577897|NCT03417778|144683105|OTHER|If the upper bound of the 2-sided 90% CIs of the GLSM ratio for Cmax of filgotinib falls within the \[50%, 200%\] bound, the null hypothesis that participants with hepatic impairment exhibit Cmax change of at least 2-fold for filgotinib compared with participants with normal liver function will be rejected.|GLSM Ratio|115.98|||||TWO_SIDED|90.0|58.75|228.98||||||An ANOVA model was fitted to the natural logarithmic transformed values of the Cmax. Two-sided 90% CI were calculated for the GLSM ratio of Cmax between hepatic impairment group versus the matched control (normal hepatic function) group.||228.98|58.75|
72577898|NCT03417778|144683106|OTHER|If the upper bound of the 2-sided 90% CIs of the GLSM ratio for Cmax of GS-829845 falls within the \[50%, 200%\] bound, the null hypothesis that participants with hepatic impairment exhibit Cmax change of at least 2-fold for GS-829845 compared with participants with normal liver function will be rejected.|GLSM Ratio|102.85|||||TWO_SIDED|90.0|60.12|175.98||||||An ANOVA model was fitted to the natural logarithmic transformed values of the Cmax. Two-sided 90% CI were calculated for the GLSM ratio of Cmax between hepatic impairment group versus the matched control (normal hepatic function) group.||175.98|60.12|
72577899|NCT01569295|144683146|SUPERIORITY||Hazard Ratio (HR)|0.35|||<|0.0001|TWO_SIDED|95.0|0.27|0.45|||Stratified log-rank test||Hazard Ratio is estimated using Cox proportional hazard model, adjusted for randomization stratification factors.|||0.45|0.27|< 0.0001
72577900|NCT01569295|144683147|SUPERIORITY||Odds Ratio (OR)|3.02|||<|0.0001|TWO_SIDED|95.0|1.98|4.62||Odds ratio,p-value and 95% Confidence Interval(CI) were calculated from Cochran-Mantel-Haenszel(CMH) Chi-square test stratified by stratification factor in EDC(del17p/TP53,immunoglobulin heavy chain variable region(IgHV) mutation and disease status).|Cochran-Mantel-Haenszel|||||4.62|1.98|<0.0001
72577901|NCT01569295|144683148|SUPERIORITY||Odds Ratio (OR)|28.81|||<|0.0001|TWO_SIDED|95.0|10.5|79.02||Odds ratio, p-value and 95% CI were calculated from the CMH Chi-square test stratified by stratification factors in EDC (del17p/TP53, IgHV mutation and disease status).|Cochran-Mantel-Haenszel|||||79.02|10.50|<0.0001
72577902|NCT01569295|144683149|SUPERIORITY||Hazard Ratio (HR)|0.78||||0.098|TWO_SIDED|95.0|0.59|1.03|||Stratified log-rank test|||||1.03|0.59|0.098
72577903|NCT01569295|144683150|SUPERIORITY||Odds Ratio (OR)|9.55||||0.011|TWO_SIDED|95.0|1.19|76.81||Odds ratio, 95% CI and p-value are calculated from the CMH Chi-square test stratified by stratification factors in EDC (del17p/TP53, IgHV mutation and disease status).|Cochran-Mantel-Haenszel|||||76.81|1.19|0.011
72577904|NCT03837743|144683192|SUPERIORITY||Mean Difference (Final Values)|0.2|STANDARD_DEVIATION|0.42||0.022|TWO_SIDED||||||Paired t-test|||Difference in Change (week 4)||||0.022
72577905|NCT03837743|144683192|SUPERIORITY||Mean Difference (Final Values)|0.2|STANDARD_DEVIATION|0.8||0.296|TWO_SIDED||||||Paired t-test|||Difference in Change (week 8)||||0.296
72577906|NCT00086281|144683212|SUPERIORITY_OR_OTHER|||||||0.009||95.0|||||ANOVA on ranks|||||||0.009
72577907|NCT00086281|144683212|SUPERIORITY_OR_OTHER|||||||0.0244||95.0||||Bonferroni adjusted P-Value|ANOVA on ranks|||||||0.0244
72577908|NCT00086281|144683212|SUPERIORITY_OR_OTHER|||||||0.0119||95.0||||Bonferroni adjusted P-Value|ANOVA on ranks|||||||0.0119
72577909|NCT00086281|144683212|SUPERIORITY_OR_OTHER|||||||0.5055||95.0||||Bonferroni adjusted P-Value|ANOVA on ranks|||||||0.5055
72577910|NCT00086281|144683212|SUPERIORITY_OR_OTHER|||||||0.3132||95.0||||Bonferroni adjusted P-Value|ANOVA on ranks|||||||0.3132
72577911|NCT04873934|144683219|SUPERIORITY||LS mean difference|-46.9|||<|0.001|TWO_SIDED|97.5|-55.4|-38.5|||Mixed Models Analysis|||||-38.5|-55.4|< 0.001
72577912|NCT04873934|144683220|SUPERIORITY||Odds Ratio (OR)|5.42|||<|0.001|TWO_SIDED|97.5|3.29|8.91|||Regression, Logistic|||||8.91|3.29|< 0.001
72410933|NCT00614939|144330238|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.14|STANDARD_ERROR_OF_MEAN|2.985|||TWO_SIDED|95.0|-8.04|3.76|||Repeated Measures|"Number of subjects with observed values at Week 52 was n=2 for saxagliptin and n=5 for placebo.~\*Adjusted for baseline FPG"||"Additional details about the analysis, such as null hypothesis and power calculation:~Due to a statistically significant treatment-by-baseline renal impairment interaction, fasting plasma glucose results were analyzed separately for each baseline renal impairment category."||3.76|-8.04|
72410934|NCT04096560|144330249|SUPERIORITY||LS Mean Difference|26.4|STANDARD_ERROR_OF_MEAN|3.15|<|0.001|TWO_SIDED|95.0|20.07|32.73||The analysis used a linear MMRM with fixed effects for baseline (Day -1 mean values), treatment, visit, and treatment-by-visit interaction. Visit was repeated factor in the model.|MMRM|The unstructured covariance structure was used for the repeated statement.||||32.73|20.07|<0.001
72410935|NCT04096560|144330249|SUPERIORITY||LS Mean Difference|29.9|STANDARD_ERROR_OF_MEAN|3.08|<|0.001|TWO_SIDED|95.0|23.68|36.07||The analysis used a linear MMRM with fixed effects for baseline (Day -1 mean values), treatment, visit, and treatment-by-visit interaction. Visit was repeated factor in the model.|MMRM|The unstructured covariance structure was used for the repeated statement.||||36.07|23.68|<0.001
72410936|NCT04096560|144330249|SUPERIORITY||LS Mean Difference|35.0|STANDARD_ERROR_OF_MEAN|3.14|<|0.001|TWO_SIDED|95.0|28.73|41.34||The analysis used a linear MMRM with fixed effects for baseline (Day -1 mean values), treatment, visit, and treatment-by-visit interaction. Visit was repeated factor in the model.|MMRM|The unstructured covariance structure was used for the repeated statement.||||41.34|28.73|<0.001
72543172|NCT01706198|144616679|OTHER||Ratio|0.99||||0.822|TWO_SIDED|95.0|0.91|1.08||GLM assuming NBD adjusted for randomized treatment, asthma maintenance therapy at Baseline per randomization stratification, ACT total score at Baseline per randomization stratification, gender and age|Generalized Linear Model (GLM)||Ratio comparing FF/VI with Usual Care has been presented.|||1.08|0.91|0.822
72543173|NCT01706198|144616680|OTHER||Ratio|1.1|||<|0.001|TWO_SIDED|95.0|1.05|1.15||GLM assuming NBD adjusted for randomized treatment, asthma maintenance therapy at Baseline per randomization stratification, ACT total score at Baseline per randomization stratification, gender and age|Generalized Linear Model (GLM)||Ratio comparing FF/VI with Usual Care has been presented.|||1.15|1.05|<0.001
72543174|NCT01706198|144616682|OTHER||Ratio|0.98||||0.697|TWO_SIDED|95.0|0.88|1.09||GLM assuming NBD adjusted for randomized treatment; asthma maintenance therapy and ACT total score at Baseline per randomization stratification; number of severe asthma exacerbations in previous year prior to randomization categorized; gender \& age|Generalized Linear Model (GLM)||Ratio comparing FF/VI with Usual Care has been presented.|||1.09|0.88|0.697
72543175|NCT01706198|144616683|OTHER||Hazard Ratio (HR)|0.96||||0.504|TWO_SIDED|95.0|0.86|1.07||Cox proportional hazards model with randomized treatment, asthma maintenance therapy at Baseline per randomization stratification, ACT total score at Baseline per randomization stratification, gender and age as covariates|Cox proportional hazards model||A hazard ratio \<1 indicated a lower risk with FF/VI compared with Usual Care|||1.07|0.86|0.504
72329455|NCT03037476|144184382|OTHER|General Linear Model|Slope|0.055||||0.793|TWO_SIDED|95.0|-0.353|0.462|||Mixed Models Analysis|Poisson Regression||Change in Past 3 Month Stimulant Use from Baseline to 12 Month Followup||.462|-.353|.793
72410937|NCT04096560|144330256|SUPERIORITY||LS Mean Difference|-10.1|STANDARD_ERROR_OF_MEAN|1.96|<|0.001|TWO_SIDED|95.0|-14.07|-6.16||The analysis used a linear MMRM with fixed effects for baseline (Day -1 mean values), treatment, visit, and treatment-by-visit interaction. Visit was repeated factor in the model.|MMRM|The unstructured covariance structure was used for the repeated statement.||||-6.16|-14.07|<0.001
72410938|NCT04096560|144330256|SUPERIORITY||LS Mean Difference|-11.4|STANDARD_ERROR_OF_MEAN|1.89|<|0.001|TWO_SIDED|95.0|-15.2|-7.56||The analysis used a linear MMRM with fixed effects for baseline (Day -1 mean values), treatment, visit, and treatment-by-visit interaction. Visit was repeated factor in the model.|MMRM|The unstructured covariance structure was used for the repeated statement.||||-7.56|-15.20|<0.001
72410939|NCT04096560|144330256|SUPERIORITY||LS Mean Difference|-13.0|STANDARD_ERROR_OF_MEAN|1.95|<|0.001|TWO_SIDED|95.0|-16.96|-9.09||The analysis used a linear MMRM with fixed effects for baseline (Day -1 mean values), treatment, visit, and treatment-by-visit interaction. Visit was repeated factor in the model.|MMRM|The unstructured covariance structure was used for the repeated statement.||||-9.09|-16.96|<0.001
72410940|NCT04096560|144330257|SUPERIORITY||IRR|0.05|||=|0.002|TWO_SIDED|95.0|0.007|0.317||The incidence rate was the exponentiated LS means and the incidence rate ratio (IRR) was the exponentiated LS mean differences from the generalized estimating equation (GEE) Poisson regression model.|MMRM|The Poisson regression with natural log link was on the count of cataplexy per week.||||0.317|0.007|=0.002
72543176|NCT01706198|144616684|OTHER||Mean Difference (Final Values)|-0.8|||<|0.001|TWO_SIDED|95.0|-1.1|-0.5||ANCOVA adjusted for randomized treatment, asthma maintenance therapy at Baseline per randomization stratification, ACT total score at Baseline per randomization stratification, gender,age \& number of salbutamol inhalers in year prior to randomization|ANCOVA||Difference of FF/VI versus Usual Care has been presented.|||-0.5|-1.1|<0.001
72410941|NCT04096560|144330257|SUPERIORITY||IRR|0.2|||=|0.019|TWO_SIDED|95.0|0.05|0.767||The incidence rate was the exponentiated LS means and the IRR was the exponentiated LS mean differences from the GEE Poisson regression model.|MMRM|The Poisson regression with natural log link was on the count of cataplexy per week.||||0.767|0.050|=0.019
72410942|NCT04096560|144330257|SUPERIORITY||IRR|0.15|||=|0.001|TWO_SIDED|95.0|0.047|0.482||The incidence rate was the exponentiated LS means and the IRR was the exponentiated LS mean differences from the GEE Poisson regression model.|MMRM|The Poisson regression with natural log link was on the count of cataplexy per week.||||0.482|0.047|=0.001
72410943|NCT01144338|144330266|SUPERIORITY|Superiority test of EQW over Placebo H0: HR ≥ 1 vs. H1: HR \< 1|Hazard Ratio (HR)|0.91||||0.061|TWO_SIDED|95.0|0.832|1.004|||Regression, Cox|||||1.004|0.832|0.061
72543177|NCT01706198|144616685|OTHER||Hazard Ratio (HR)|1.23|||<|0.001|TWO_SIDED|95.0|1.09|1.38||Cox proportional hazards model with randomized treatment, asthma maintenance therapy at Baseline per randomization stratification, ACT total score at Baseline per randomization stratification, gender and age as covariates|Cox proportional hazards model||Hazard ratio for FF/VI versus Usual Care has been presented|||1.38|1.09|<0.001
72577913|NCT04873934|144683221|SUPERIORITY||LS mean difference|-42.0|||<|0.001|TWO_SIDED|95.0|-47.3|-36.7|||Mixed Models Analysis|||Day 90||-36.7|-47.3|< 0.001
72543178|NCT01706198|144616686|OTHER||Adjusted Odds Ratio|1.79|||<|0.001|TWO_SIDED|95.0|1.55|2.06||Logistic regression adjusted for randomized treatment, asthma maintenance therapy at Baseline per randomization stratification, ACT total score at Baseline per randomization stratification, gender, age and Baseline score.|Regression, Logistic||Adjusted odds ratio of FF/VI with Usual Care has been presented.|||2.06|1.55|<0.001
72543179|NCT01706198|144616687|OTHER||Adjusted Odds Ratio|1.51|||<|0.001|TWO_SIDED|95.0|1.31|1.73||Logistic regression adjusted for randomized treatment, asthma maintenance therapy at Baseline per randomization stratification, ACT total score at Baseline per randomization stratification, gender, age and Baseline score.|Regression, Logistic||Adjusted odds ratio of FF/VI versus Usual Care has been presented.|||1.73|1.31|<0.001
72543180|NCT01706198|144616688|NON_INFERIORITY|Non-inferiority is demonstrated if the upper limit of the two-sided 95% confidence interval for the incidence ratio is less than 2.|Incidence ratio|1.4|||||TWO_SIDED|95.0|0.8|2.7|||||Incidence ratio was calculated as percentage of participants who had at least one SAE of pneumonia in the FF/VI group divided by the percentage of participants who had at least one SAE of pneumonia in the Usual Care group.|||2.7|0.8|
72543181|NCT01706198|144616689|OTHER||Hazard Ratio (HR)|1.45||||0.255|TWO_SIDED|95.0|0.77|2.74||Cox proportional hazards model with randomized treatment, asthma maintenance therapy at Baseline per randomization stratification, ACT total score at Baseline per randomization stratification, gender and age as covariates.|Cox proportional hazards model||Hazard ratio for FF/VI versus Usual Care has been presented.|||2.74|0.77|0.255
72543182|NCT04229303|144616709|OTHER||Slope|0.62|||<|0.0001|TWO_SIDED|90.0|0.424|0.821|||General power constant model|||Statistics for Voriconazole AUC0-t||0.821|0.424|<0.0001
72543183|NCT04229303|144616709|OTHER||Slope|1.21||||0.0363|TWO_SIDED|90.0|1.05|1.362|||General power linear model|||Statistics for Voriconazole AUC0-t||1.362|1.050|0.0363
72543184|NCT04229303|144616709|OTHER||Geometric mean difference|13.48|||<|0.0001|TWO_SIDED|90.0|10.096|17.994|||ANOVA|||Statistics for Voriconazole AUC0-t, 40mg vs 5mg||17.994|10.096|<0.0001
72543185|NCT04229303|144616709|OTHER||Slope|1.85|||<|0.0001|TWO_SIDED|90.0|1.728|1.963|||General power constant model|||Statistics for N-oxide Voriconazole AUC0-t||1.963|1.728|<0.0001
72543186|NCT04229303|144616709|OTHER||Slope|0.87||||0.0201|TWO_SIDED|90.0|0.789|0.96|||General power linear model|||Statistics for N-oxide Voriconazole AUC0-t||0.960|0.789|0.0201
72543187|NCT04229303|144616709|OTHER||Geometric mean difference|6.16|||<|0.0001|TWO_SIDED|90.0|5.253|7.217|||ANOVA|||Statistics for N-oxide Voriconazole AUC0-t, 40mg vs 5mg||7.217|5.253|<0.0001
72543188|NCT04229303|144616709|OTHER||Slope|0.81|||<|0.0001|TWO_SIDED|90.0|0.661|0.958|||General power constant model|||Statistics for Voriconazole AUC0-inf||0.958|0.661|<0.0001
72543189|NCT04229303|144616709|OTHER||Slope|1.12||||0.1278|TWO_SIDED|90.0|0.99|1.245|||General power linear model|||Statistics for Voriconazole AUC0-inf||1.245|0.990|0.1278
72543190|NCT04229303|144616709|OTHER||Geometric mean difference|9.43|||<|0.0001|TWO_SIDED|90.0|6.834|13.012|||ANOVA|||Statistics for Voriconazole AUC0-inf, 40mg vs 5mg||13.012|6.834|<0.0001
72577914|NCT04873934|144683221|SUPERIORITY||LS mean difference|-30.8|||<|0.001|TWO_SIDED|95.0|-37.4|-24.3|||Mixed Models Analysis|||Day 270||-24.3|-37.4|< 0.001
72543191|NCT04229303|144616709|OTHER||Slope|1.98|||<|0.0001|TWO_SIDED|90.0|1.86|2.106|||General power constant model|||Statistics for N-oxide Voriconazole AUC0-inf||2.106|1.860|<0.0001
72543192|NCT04229303|144616709|OTHER||Slope|0.79||||0.0082|TWO_SIDED|90.0|0.67|0.912|||General power linear model|||Statistics for N-oxide Voriconazole AUC0-inf||0.912|0.670|0.0082
72543193|NCT04229303|144616709|OTHER||Geometric mean difference|5.86|||<|0.0001|TWO_SIDED|90.0|4.627|7.421|||ANOVA|||Statistics for N-oxide Voriconazole AUC0-inf, 40mg vs 5mg||7.421|4.627|<0.0001
72543194|NCT04229303|144616710|OTHER||Slope|0.12||||0.2575|TWO_SIDED|90.0|-0.06|0.308|||General power constant model|||Statistics for Voriconazole Cmax||0.308|-0.060|0.2575
72543195|NCT04229303|144616710|OTHER||Slope|1.17||||0.0491|TWO_SIDED|90.0|1.03|1.316|||General power linear model|||Statistics for Voriconazole Cmax||1.316|1.030|0.0491
72543196|NCT04229303|144616710|OTHER||Geometric mean difference|11.17|||<|0.0001|TWO_SIDED|90.0|8.435|14.803|||ANOVA|||Statistics for Voriconazole Cmax, 40mg vs 5mg||14.803|8.435|<0.0001
72543197|NCT04229303|144616710|OTHER||Slope|1.25|||<|0.0001|TWO_SIDED|90.0|1.135|1.363|||General power constant model|||Statistics for N-oxide Voriconazole Cmax||1.363|1.135|<0.0001
72543198|NCT04229303|144616710|OTHER||Slope|0.74||||0.0003|TWO_SIDED|90.0|0.634|0.843|||General power linear model|||Statistics for N-oxide Voriconazole Cmax||0.843|0.634|0.0003
72543199|NCT04229303|144616710|OTHER||Geometric mean difference|4.97|||<|0.0001|TWO_SIDED|90.0|3.946|6.254|||ANOVA|||Statistics for N-oxide Voriconazole Cmax, 40mg vs 5mg||6.254|3.946|<0.0001
72543200|NCT04229303|144616717|OTHER||Slope|2.0||||0.0004|TWO_SIDED|90.0|1.528|2.617|||ANOVA|||Statistics for Voriconazole AUC0-t Day 1||2.617|1.528|0.0004
72543201|NCT04229303|144616717|OTHER||Slope|4.73|||<|0.0001|TWO_SIDED|90.0|3.612|6.187|||ANOVA|||Statistics for Voriconazole AUC0-t Day 1||6.187|3.612|<0.0001
72543202|NCT04229303|144616717|OTHER||Slope|2.81|||<|0.0001|TWO_SIDED|90.0|2.017|3.925|||ANOVA|||Statistics for Voriconazole AUC0-t day 10||3.925|2.017|<0.0001
72543203|NCT04229303|144616717|OTHER||Slope|5.28|||<|0.0001|TWO_SIDED|90.0|3.783|7.361|||ANOVA|||Statistics for Voriconazole AUC0-t Day 10||7.361|3.783|<0.0001
72543204|NCT04229303|144616717|OTHER||Slope|1.97|||<|0.0001|TWO_SIDED|90.0|1.615|2.396|||ANOVA|||Statistics for N-oxide Voriconazole AUC0-t Day 1||2.396|1.615|<0.0001
72543205|NCT04229303|144616717|OTHER||Slope|5.09|||<|0.0001|TWO_SIDED|90.0|4.178|6.196|||ANOVA|||Statistics for N-oxide Voriconazole AUC0-t Day 1||6.196|4.178|<0.0001
72543206|NCT04229303|144616717|OTHER||Slope|2.45||||0.0002|TWO_SIDED|90.0|1.791|3.349|||ANOVA|||Statistics for N-oxide Voriconazole AUC0-t Day 10||3.349|1.791|0.0002
72577915|NCT04873934|144683221|SUPERIORITY||LS mean difference|-37.7|||<|0.001|TWO_SIDED|95.0|-44.5|-31.0|||Mixed Models Analysis|||Day 330||-31.0|-44.5|< 0.001
72577916|NCT04873934|144683222|SUPERIORITY||LS mean difference|-46.7|||<|0.001|TWO_SIDED|95.0|-52.7|-40.8|||ANCOVA|||||-40.8|-52.7|< 0.001
72543207|NCT04229303|144616717|OTHER||Slope|4.6|||<|0.0001|TWO_SIDED|90.0|3.365|6.294|||ANOVA|||Statistics for N-oxide Voriconazole AUC0-t Day 10||6.294|3.365|<0.0001
72543208|NCT04229303|144616717|OTHER||Slope|1.99||||0.0005|TWO_SIDED|90.0|1.524|2.602|||ANOVA|||Statistics for Voriconazole AUC0-inf Day 1||2.602|1.524|0.0005
72543209|NCT04229303|144616717|OTHER||Slope|4.58|||<|0.0001|TWO_SIDED|90.0|3.505|5.984|||ANOVA|||Statistics for Voriconazole AUC0-inf Day 1||5.984|3.505|<0.0001
72543210|NCT04229303|144616717|OTHER||Slope|2.65||||0.0003|TWO_SIDED|90.0|1.851|3.781|||ANOVA|||Statistics for Voriconazole AUC0-inf Day 10||3.781|1.851|0.0003
72543211|NCT04229303|144616717|OTHER||Slope|5.04|||<|0.0001|TWO_SIDED|90.0|3.587|7.088|||ANOVA|||Statistics for Voriconazole AUC0-inf Day 10||7.088|3.587|<0.0001
72543212|NCT04229303|144616717|OTHER||Slope|1.93|||<|0.0001|TWO_SIDED|90.0|1.569|2.384|||ANOVA|||Statistics for N-oxide Voriconazole AUC0-inf Day 1||2.384|1.569|<0.0001
72543213|NCT04229303|144616717|OTHER||Slope|4.56|||<|0.0001|TWO_SIDED|90.0|3.608|5.759|||ANOVA|||Statistics for N-oxide Voriconazole AUC0-inf Day 1||5.759|3.608|<0.0001
72543214|NCT04229303|144616717|OTHER||Slope|2.4||||0.0007|TWO_SIDED|90.0|1.694|3.402|||ANOVA|||Statistics for N-oxide Voriconazole AUC0-inf Day 10||3.402|1.694|0.0007
72543215|NCT04229303|144616717|OTHER||Slope|4.22|||<|0.0001|TWO_SIDED|90.0|2.975|5.974|||ANOVA|||Statistics for N-oxide Voriconazole AUC0-inf Day 10||5.974|2.975|<0.0001
72543216|NCT04229303|144616718|OTHER||Slope|2.03||||0.0003|TWO_SIDED|90.0|1.562|2.65|||ANOVA|||Statistics for Voriconazole Cmax Day 1||2.650|1.562|0.0003
72543217|NCT04229303|144616718|OTHER||Slope|4.87|||<|0.0001|TWO_SIDED|90.0|3.74|6.345|||ANOVA|||Statistics for Voriconazole Cmax Day 1||6.345|3.740|<0.0001
72543218|NCT04229303|144616718|OTHER||Slope|2.67|||<|0.0001|TWO_SIDED|90.0|2.081|3.429|||ANOVA|||Statistics for Voriconazole Cmax Day 10||3.429|2.081|<0.0001
72543219|NCT04229303|144616718|OTHER||Slope|5.97|||<|0.0001|TWO_SIDED|90.0|4.647|7.658|||ANOVA|||Statistics for Voriconazole Cmax Day 10||7.658|4.647|<0.0001
72543220|NCT04229303|144616718|OTHER||Slope|2.02|||<|0.0001|TWO_SIDED|90.0|1.688|2.406|||ANOVA|||Statistics for N-oxide Voriconazole Cmax Day 1||2.406|1.688|<0.0001
72543221|NCT04229303|144616718|OTHER||Slope|4.73|||<|0.0001|TWO_SIDED|90.0|3.964|5.65|||ANOVA|||Statistics for N-oxide Voriconazole Cmax Day 1||5.650|3.964|<0.0001
72543222|NCT04229303|144616718|OTHER||Slope|2.12|||<|0.0001|TWO_SIDED|90.0|1.655|2.711|||ANOVA|||Statistics for N-oxide Voriconazole Cmax Day 10||2.711|1.655|<0.0001
72543223|NCT04229303|144616718|OTHER||Slope|4.01|||<|0.0001|TWO_SIDED|90.0|3.135|5.135|||ANOVA|||Statistics for N-oxide Voriconazole Cmax day 10||5.135|3.135|<0.0001
72543224|NCT04229303|144616739|OTHER||Geometric mean ratio|0.13|||||TWO_SIDED|90.0|0.107|0.146||||||Part 3 - ZP-059 20mg: Oral Voriconazole (200mg VFEND)||0.146|0.107|
72543225|NCT04229303|144616739|OTHER||Geometric mean ratio|2.1|||||TWO_SIDED|90.0|1.545|2.853||||||ZP-059 20mg: Part 3 / Part 1||2.853|1.545|
72543226|NCT04229303|144616739|OTHER||Geometric mean ratio|2.63|||||TWO_SIDED|90.0|1.953|3.544||||||ZP-059 20mg: Part 3 / Part 2 Day 1||3.544|1.953|
72543227|NCT04229303|144616739|OTHER||Geometric mean ratio|1.87|||||TWO_SIDED|90.0|1.386|2.52||||||ZP-059 20mg: Part 3 / Part 2 Day 10||2.520|1.386|
72543228|NCT04229303|144616740|OTHER||Geometric mean ratio|0.07|||||TWO_SIDED|90.0|0.059|0.075||||||Part 3 ZP-059 20mg: Oral Voriconazole (200mg VFEND®)||0.075|0.059|
72543229|NCT04229303|144616740|OTHER||Geometric mean ratio|1.27|||||TWO_SIDED|90.0|0.85|1.891||||||ZP-059 20mg: Part 3 / Part 1||1.891|0.850|
72543230|NCT04229303|144616740|OTHER||Geometric mean ratio|2.63|||||TWO_SIDED|90.0|1.953|3.544||||||ZP-059 20mg: Part 3 / Part 2 Day 1||3.544|1.953|
72543231|NCT04229303|144616740|OTHER||Geometric mean ratio|1.87|||||TWO_SIDED|90.0|1.386|2.52||||||ZP-059 20mg: Part 3 / Part 2 Day 10||2.520|1.386|
72543232|NCT00606684|144616741|SUPERIORITY_OR_OTHER||Least squares mean difference|0.092|||<|0.001|TWO_SIDED|95.0|0.039|0.144|||ANCOVA|||||0.144|0.039|<0.001
72543233|NCT00606684|144616741|SUPERIORITY_OR_OTHER||Least squares mean difference|0.098|||<|0.001|TWO_SIDED|95.0|0.046|0.15|||ANCOVA|||||0.150|0.046|<0.001
72543234|NCT00606684|144616741|SUPERIORITY_OR_OTHER||Least squares mean difference|0.11|||<|0.001|TWO_SIDED|95.0|0.057|0.162|||ANCOVA|||||0.162|0.057|<0.001
72543235|NCT00606684|144616741|SUPERIORITY_OR_OTHER||Least squares mean difference|0.137|||<|0.001|TWO_SIDED|95.0|0.085|0.19|||ANCOVA|||||0.190|0.085|<0.001
72543236|NCT00606684|144616741|SUPERIORITY_OR_OTHER||Least squares mean difference|0.165|||<|0.001|TWO_SIDED|95.0|0.112|0.217|||ANCOVA|||||0.217|0.112|<0.001
72577917|NCT04873934|144683223|SUPERIORITY||LS mean difference|-37.3|||<|0.001|TWO_SIDED|95.0|-42.4|-32.2|||ANCOVA|||||-32.2|-42.4|< 0.001
72577918|NCT04873934|144683224|SUPERIORITY||Odds Ratio (OR)|11.87|||<|0.001|TWO_SIDED|95.0|6.33|22.25|||Regression, Logistic|||||22.25|6.33|< 0.001
72577919|NCT04873934|144683225|SUPERIORITY||Odds Ratio (OR)|4.38|||<|0.001|TWO_SIDED|95.0|1.92|9.99|||Regression, Logistic|||Achieving LDL-C \< 100 mg/dL||9.99|1.92|< 0.001
72543237|NCT02763579|144616745|SUPERIORITY||Stratified Hazard Ratio|0.77||||0.017|TWO_SIDED|95.0|0.62|0.96|||Log Rank|||||0.96|0.62|0.0170
72543238|NCT02763579|144616746|SUPERIORITY||Stratified Hazard Ratio|0.7||||0.0069|TWO_SIDED|95.0|0.54|0.91|||Log Rank|||||0.91|0.54|0.0069
72543239|NCT02763579|144616747|SUPERIORITY||Odds Ratio (OR)|0.87|||||TWO_SIDED|95.0|0.55|1.37||||||||1.37|0.55|
72543240|NCT02763579|144616748|SUPERIORITY||Hazard Ratio (HR)|0.715||||0.0063|TWO_SIDED|95.0|0.562|0.911|||Log Rank|||||0.911|0.562|0.0063
72543241|NCT02763579|144616749|SUPERIORITY||Difference in Event Free Rate|8.47||||0.0593|TWO_SIDED|95.0|-0.33|17.27|||Z-test|||PFS Rate at 6 months||17.27|-0.33|0.0593
72543242|NCT02763579|144616749|SUPERIORITY||Difference in Event Free Rate|7.27||||0.0133|TWO_SIDED|95.0|1.52|13.02|||Z-test|||PFS Rate at 1 year||13.02|1.52|0.0133
72543243|NCT02763579|144616750|SUPERIORITY||Difference in Event Free Rate|13.46||||0.0095|TWO_SIDED|95.0|3.29|23.64|||Z-test|||OS Rate at 1 year||23.64|3.29|0.0095
72543244|NCT02763579|144616751|SUPERIORITY|Stratified analysis. Stratification factors: Sex (male vs female) and ECOG (0 vs 1).|Hazard Ratio (HR)|1.221||||0.3604|TWO_SIDED|95.0|0.795|1.874|||Log Rank|||Cough||1.874|0.795|0.3604
72543245|NCT02763579|144616751|SUPERIORITY|Stratified analysis. Stratification factors: Sex (male vs female) and ECOG (0 vs 1).|Hazard Ratio (HR)|1.058||||0.7712|TWO_SIDED|95.0|0.722|1.553|||Log Rank|||Pain in Chest||1.553|0.722|0.7712
72543246|NCT02763579|144616751|SUPERIORITY|Stratified analysis. Stratification factors: Sex (male vs female) and ECOG (0 vs 1).|Hazard Ratio (HR)|1.077||||0.6922|TWO_SIDED|95.0|0.747|1.552|||Log Rank|||Pain in Arm or Shoulder||1.552|0.747|0.6922
72543247|NCT02763579|144616751|SUPERIORITY|Stratified analysis. Stratification factors: Sex (male vs female) and ECOG (0 vs 1).|Hazard Ratio (HR)|0.748||||0.065|TWO_SIDED|95.0|0.549|1.019|||Log Rank|||Dyspnea||1.019|0.549|0.0650
72543248|NCT02144259|144616758|SUPERIORITY_OR_OTHER||||||<|0.05|||||||GEE|||Because the expected amount of postpartum weight loss in non-breastfeeding women is not documented in the literature, we chose a sample size that would enable us to detect a one standard deviation difference in weight loss between the 3 groups at the primary 6 month endpoint. We used generalized estimating equations (GEEs) to test differences among all 3 groups over all the study periods.||||<0.05
72543249|NCT02144259|144616760|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Chi-squared|||||||<0.05
72543250|NCT04169282|144616778|SUPERIORITY|||||||0.108|||||||t-test, 1 sided|paired t-test for normally distributed and transformed data or Wilcoxon's Signed Rank test for non-parametric paired data||||||0.108
72543251|NCT04169282|144616779|SUPERIORITY|||||||0.003|||||||t-test, 1 sided|paired t-test for normally distributed and transformed data or Wilcoxon's Signed Rank test for non-parametric paired data||||||0.003
72543252|NCT04169282|144616780|SUPERIORITY|||||||0.025|||||||t-test, 1 sided|paired t-test for normally distributed and transformed data or Wilcoxon's Signed Rank test for non-parametric paired data||||||0.025
72543253|NCT00621686|144616787|SUPERIORITY_OR_OTHER|||||||0.069|||||||Log Rank|||||||0.069
72543254|NCT01170364|144616802|SUPERIORITY||||||<|0.004|||||||paired sample t-test, two tailed|||||||<0.004
72543255|NCT01381900|144616803|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-0.51|STANDARD_ERROR_OF_MEAN|0.071|<|0.001|TWO_SIDED|95.0|-0.644|-0.367|||ANCOVA|||||-0.367|-0.644|<0.001
72543256|NCT01381900|144616803|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-0.59|STANDARD_ERROR_OF_MEAN|0.071|<|0.001|TWO_SIDED|95.0|-0.731|-0.453|||ANCOVA|||||-0.453|-0.731|<0.001
72543257|NCT01381900|144616804|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-1.03|STANDARD_ERROR_OF_MEAN|0.173|<|0.001|TWO_SIDED|95.0|-1.375|-0.694|||ANCOVA|||||-0.694|-1.375|<0.001
72577920|NCT04873934|144683225|SUPERIORITY||Odds Ratio (OR)|8.24|||<|0.001|TWO_SIDED|95.0|4.97|13.65|||Regression, Logistic|||Achieving LDL-C \< 55 mg/dL||13.65|4.97|< 0.001
72577921|NCT04873934|144683226|SUPERIORITY||LS mean difference|-37.5|||<|0.001|TWO_SIDED|95.0|-44.8|-30.3|||Mixed Models Analysis|||Apolipoprotein B||-30.3|-44.8|< 0.001
72577922|NCT04873934|144683226|SUPERIORITY||LS mean difference|-6.4||||0.188|TWO_SIDED|95.0|-16.0|3.1|||Mixed Models Analysis|||VLDL Cholesterol||3.1|-16.0|0.188
72577923|NCT04873934|144683226|SUPERIORITY||LS mean difference|-37.7|||<|0.001|TWO_SIDED|95.0|-44.0|-31.4|||Mixed Models Analysis|||Non-HDL Cholesterol||-31.4|-44.0|< 0.001
72577924|NCT04873934|144683226|SUPERIORITY||LS mean difference|-25.5|||<|0.001|TWO_SIDED|95.0|-30.2|-20.7|||Mixed Models Analysis|||Total Cholesterol||-20.7|-30.2|< 0.001
72577925|NCT04873934|144683226|SUPERIORITY||LS mean difference|-16.4||||0.145|TWO_SIDED|95.0|-38.4|5.7|||Mixed Models Analysis|||Lipoprotein(a)||5.7|-38.4|0.145
72577926|NCT04873934|144683226|SUPERIORITY||LS mean difference|3.5||||0.141|TWO_SIDED|95.0|-1.2|8.1|||Mixed Models Analysis|||HDL Cholesterol||8.1|-1.2|0.141
72577927|NCT04873934|144683226|SUPERIORITY||LS mean difference|-5.0||||0.339|TWO_SIDED|95.0|-15.2|5.3|||Mixed Models Analysis|||Triglycerides||5.3|-15.2|0.339
72577928|NCT04873934|144683227|SUPERIORITY||LS mean difference|-28.4|||<|0.001|TWO_SIDED|95.0|-33.0|-23.9|||Mixed Models Analysis|||Apolipoprotein B||-23.9|-33.0|< 0.001
72577929|NCT04873934|144683227|SUPERIORITY||LS mean difference|-2.1||||0.078|TWO_SIDED|95.0|-4.5|0.2|||Mixed Models Analysis|||VLDL Cholesterol||0.2|-4.5|0.078
72577930|NCT04873934|144683227|SUPERIORITY||LS mean difference|-40.1|||<|0.001|TWO_SIDED|95.0|-47.5|-32.8|||Mixed Models Analysis|||Non-HDL Cholesterol||-32.8|-47.5|< 0.001
72577931|NCT04873934|144683227|SUPERIORITY||LS mean difference|-37.7|||<|0.001|TWO_SIDED|95.0|-45.3|-30.2|||Mixed Models Analysis|||Total Cholesterol||-30.2|-45.3|< 0.001
72577932|NCT04873934|144683227|SUPERIORITY||LS mean difference|1.9||||0.065|TWO_SIDED|95.0|-0.1|3.8|||Mixed Models Analysis|||HDL Cholesterol||3.8|-0.1|0.065
72577933|NCT04873934|144683227|SUPERIORITY||LS mean difference|-8.7||||0.222|TWO_SIDED|95.0|-22.8|5.3|||Mixed Models Analysis|||Triglycerides||5.3|-22.8|0.222
72577934|NCT04873934|144683228|SUPERIORITY||LS mean difference|-14.0||||0.005|TWO_SIDED|95.0|-23.8|-4.2|||Mixed Models Analysis|||Lipoprotein(a)||-4.2|-23.8|0.005
72577935|NCT04873934|144683229|SUPERIORITY||Odds Ratio (OR)|0.43||||0.031|TWO_SIDED|95.0|0.2|0.93|||proportional odds model|||||0.93|0.20|0.031
72577936|NCT04873934|144683230|SUPERIORITY||LS mean difference|-0.039||||0.043|TWO_SIDED|95.0|-0.077|-0.001|||ANCOVA|||||-0.001|-0.077|0.043
72577937|NCT04873934|144683231|SUPERIORITY||Odds Ratio (OR)|0.76||||0.346|TWO_SIDED|95.0|0.43|1.35|||Regression, Logistic|||||1.35|0.43|0.346
72577938|NCT04803305|144683287|SUPERIORITY||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|1.01|||TWO_SIDED|90.0|-2.38|1.18|||||Week 4|||1.18|-2.38|
72577939|NCT04803305|144683288|SUPERIORITY||Mean Difference (Final Values)|1.2|STANDARD_ERROR_OF_MEAN|1.07|||TWO_SIDED|90.0|-0.75|3.15|||||Week 1|||3.15|-0.75|
72577940|NCT04803305|144683288|SUPERIORITY||Mean Difference (Final Values)|1.1|STANDARD_ERROR_OF_MEAN|0.78|||TWO_SIDED|90.0|-0.28|2.49|||||Week 2|||2.49|-0.28|
72577941|NCT04803305|144683288|SUPERIORITY||Mean Difference (Final Values)|1.03|STANDARD_ERROR_OF_MEAN|1.11|||TWO_SIDED|90.0|-0.93|2.99|||||Week 3|||2.99|-0.93|
72577942|NCT04803305|144683288|SUPERIORITY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|1.14|||TWO_SIDED|90.0|-2.02|2.02|||||Week 5|||2.02|-2.02|
72577943|NCT04803305|144683288|SUPERIORITY||Mean Difference (Final Values)|-0.8|STANDARD_ERROR_OF_MEAN|1.29|||TWO_SIDED|90.0|-3.11|1.51|||||Week 6|||1.51|-3.11|
72577944|NCT04803305|144683289|SUPERIORITY||Mean Difference (Final Values)|-0.32|STANDARD_ERROR_OF_MEAN|1.98|||TWO_SIDED|90.0|-4.18|3.53|||||Week 1|||3.53|-4.18|
72577945|NCT04803305|144683289|SUPERIORITY||Mean Difference (Final Values)|-2.16|STANDARD_ERROR_OF_MEAN|1.58|||TWO_SIDED|90.0|-5.49|1.16|||||Week 2|||1.16|-5.49|
72577946|NCT04803305|144683289|SUPERIORITY||Mean Difference (Final Values)|0.72|STANDARD_ERROR_OF_MEAN|0.76|||TWO_SIDED|90.0|-0.62|2.06|||||Week 3|||2.06|-0.62|
72577947|NCT04803305|144683289|SUPERIORITY||Mean Difference (Final Values)|0.45|STANDARD_ERROR_OF_MEAN|0.97|||TWO_SIDED|90.0|-1.29|2.2|||||Week 4|||2.20|-1.29|
72577948|NCT04803305|144683289|SUPERIORITY||Mean Difference (Final Values)|0.68|STANDARD_ERROR_OF_MEAN|1.04|||TWO_SIDED|90.0|-1.21|2.57|||||Week 5|||2.57|-1.21|
72410944|NCT01144338|144330267|NON_INFERIORITY|Non-inferiority test of EQW over Placebo H0: HR ≥ 1.3 vs. H1: HR \< 1.3|Hazard Ratio (HR)|0.91|||<|0.001|TWO_SIDED|95.0|0.832|1.004|||Regression, Cox|||This analysis uses the same endpoint and cox regression method as the primary efficacy analysis. However, the statistical hypothesis is a non-inferiority test with a margin of HR=1.3.||1.004|0.832|< 0.001
72577949|NCT04803305|144683289|SUPERIORITY||Mean Difference (Final Values)|1.86|STANDARD_ERROR_OF_MEAN|0.84|||TWO_SIDED|90.0|0.34|3.39|||||Week 6|||3.39|0.34|
72577950|NCT00754546|144683292|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0|||||ANOVA|||"ANOVA was used to examine the interaction between mode of exercise and treatment effect.~Twenty patients were considered adequate to provide a power of 85% with an alpha of 0.05."||||< 0.05
72577951|NCT00754546|144683292|SUPERIORITY_OR_OTHER|||||||0.024||95.0|||||t-test, 2 sided|||Comparing arformoterol with placebo with treadmill exercise||||0.024
72577952|NCT00754546|144683292|SUPERIORITY_OR_OTHER|||||||0.038||95.0|||||t-test, 2 sided|||Arformoterol versus normal saline with cycle exercise||||0.038
72577953|NCT03765788|144683320|SUPERIORITY||Odds Ratio (OR)|9.31|||||TWO_SIDED|95.0|3.54|26.29|||||Odd Ratio (posterior median) median and 95% credibility interval calculated using the Bayesian inference|Odds Ratio||26.29|3.54|
72577954|NCT00113763|144683341|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||Log Rank|Stratified by baseline IVRS ECOG performance status and geographic region||Null hypothesis was no difference between treatment groups||||<0.0001
72577955|NCT00113763|144683342|SUPERIORITY_OR_OTHER_LEGACY|||||||0.806||||||This analysis was conducted contingent on a statistically significant difference in the primary outcome, and adjusted to an a priori threshold for statistical significance at a 4% level for a multiple comparison involving objective tumor response|Log Rank|Stratified by baseline IVRS ECOG performance status and geographic region||Null hypothesis was no difference between treatment groups||||0.806
72577956|NCT04933383|144683351|SUPERIORITY||difference/ratio of least square means|180.6||||0.000813|TWO_SIDED|95.0|106.42|306.48|||ANCOVA|||"The primary efficacy endpoint is the change from baseline in PC20 after each treatment period (baseline is defined at Visit 1).~For primary efficacy analysis, the mean PC20 changes from baseline between AQ001S and the comparator were compared by analysis of covariance (ANCOVA) for crossover design. A p-value was calculated for the difference of the parameter between AQ001S and the comparator.~Additionally, an adjusted 95%-CI for the mean difference was obtained by the ANCOVA."||306.48|106.42|0.000813
72577957|NCT00180661|144683353|SUPERIORITY|||||||0.001|||||||t-test, 2 sided|||||||0.001
72577958|NCT00180661|144683354|SUPERIORITY|||||||0.005|||||||t-test, 2 sided|||||||0.005
72577959|NCT02794870|144683383|OTHER||% vaccine recipients with solicited AEs|60.0|||||TWO_SIDED|90.0|39.0|78.0||||||||78|39|
72577960|NCT02794870|144683383|OTHER||% placebo recipients with solicited AEs|27.0|||||TWO_SIDED|90.0|8.0|56.0||||||||56|8|
72577961|NCT02794870|144683384|OTHER||% vaccinees with unsolicited AEs|35.0|||||TWO_SIDED|90.0|18.0|56.0||||||||56|18|
72577962|NCT02794870|144683384|OTHER||% placebo with unsolicited AEs|18.0|||||TWO_SIDED|90.0|3.0|47.0||||||||47|3|
72577963|NCT02794870|144683389|SUPERIORITY||||||<|0.01||||||Due to unequal sample sizes, a 1-sided Fisher's exact test was used to test the hypothesis that proportions of greater than or equal to 4-fold rises were higher in the vaccinated than in the placebo group. Statistical significance level was 0.05.|Fisher Exact|||||||<0.01
72577964|NCT02794870|144683390|SUPERIORITY||||||<|0.001||||||The threshold for statistical significance is 0.05.|Log Rank|||||||<0.001
72577965|NCT02652611|144683399|SUPERIORITY||Odds Ratio (OR)|0.3|||=|0.57|TWO_SIDED|95.0|-0.8|1.4|||t-test, 2 sided|||We reported the average pain and function from 6 to 24 months postinjury with 95% confidence intervals (CIs) and summarized pain and function at 6, 9, 12, 18, and 24 months postinjury with means and standard deviations and medians with interquartile ranges.||1.4|-0.8|=0.57
72577966|NCT02652611|144683400|SUPERIORITY||Mean Difference (Final Values)|4.7||||0.21|TWO_SIDED|95.0|-2.9|12.3|||t-test, 2 sided|||||12.3|-2.9|0.21
72577967|NCT02237092|144683403|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<0.001
72577968|NCT02237092|144683404|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
72577969|NCT02237092|144683405|SUPERIORITY_OR_OTHER||||||<|0.02|TWO_SIDED||||||t-test, 2 sided|||||||<0.02
72577970|NCT02237092|144683406|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.58|||<|0.05|TWO_SIDED|95.0|1.05|2.58|||NNT|||||2.58|1.05|<0.05
72577971|NCT02661217|144683445|SUPERIORITY||Risk Ratio (RR)|0.896||||0.099|TWO_SIDED|95.0|0.786|1.021|||Cochran-Mantel-Haenszel|||||1.021|0.786|0.099
72577972|NCT02661217|144683446|SUPERIORITY||Risk Ratio (RR)|0.906||||0.034|TWO_SIDED|95.0|0.827|0.993|||Cochran-Mantel-Haenszel|||||0.993|0.827|0.034
72577973|NCT02661217|144683447|SUPERIORITY||Risk Ratio (RR)|0.96||||0.089|TWO_SIDED|95.0|0.916|1.006|||Cochran-Mantel-Haenszel|||||1.006|0.916|0.089
72577974|NCT02604407|144683452|SUPERIORITY_OR_OTHER_LEGACY||Difference of LS Mean|-8.1|||<|0.001|TWO_SIDED|95.0|-11.7|-4.4|||Mixed-effects model for repeated measure||Between treatment groups of SHP465 12.5 mg and Placebo.|||-4.4|-11.7|<0.001
72577975|NCT02604407|144683452|SUPERIORITY_OR_OTHER_LEGACY||Difference of LS Mean|-13.4|||<|0.001|TWO_SIDED|95.0|-17.1|-9.7|||Mixed-effects model for repeated measure||Between treatment groups of SHP465 37.5 mg and Placebo.|||-9.7|-17.1|<0.001
72577976|NCT02054338|144683546|SUPERIORITY||Hazard Ratio (HR)|1.05||||0.54|TWO_SIDED|95.0|0.91|1.2|||Log Rank|||Kaplan-Meier curves and life tables by treatment arm to describe time-dependent parameters. Stratified Cox proportional model was used to compare the 2 treatment arms. A stratified Cox proportional hazards model and logistic regression were applied to the progression-free survival and to the tumour response, respectively.||1.20|0.91|0.54
72577977|NCT02054338|144683547|SUPERIORITY||Hazard Ratio (HR)|0.98||||0.86|TWO_SIDED|95.0|0.87|1.19|||Log Rank|||||1.19|0.87|0.86
72577978|NCT02054338|144683548|SUPERIORITY||Hazard Ratio (HR)|11.3||||0.1|TWO_SIDED|95.0|8.7|14.4|||Log Rank|||||14.4|8.7|0.10
72577979|NCT00428116|144683561|SUPERIORITY_OR_OTHER|||||||0.15|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||WAZ-score comparison at 18 months||||0.15
72577980|NCT00428116|144683561|SUPERIORITY_OR_OTHER|||||||0.45|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||HAZ score at 18 months||||0.45
72577981|NCT00428116|144683562|SUPERIORITY_OR_OTHER|||||||0.39|TWO_SIDED||||||log rank or Cox regression|incidence with Cox regression utilized Anderson-Gill method to handle recurrent events||SAEs||||0.39
72577982|NCT00428116|144683562|SUPERIORITY_OR_OTHER|||||||0.6|TWO_SIDED||||||Cox regression Anderson Gill|||Pneumonia||||0.60
72577983|NCT00428116|144683562|SUPERIORITY_OR_OTHER|||||||0.6|TWO_SIDED||||||Regression, Cox|||Pneumonia||||0.60
72577984|NCT00428116|144683562|SUPERIORITY_OR_OTHER|||||||0.77|TWO_SIDED||||||Regression, Cox|||Diarrhea||||0.77
72577985|NCT00428116|144683562|SUPERIORITY_OR_OTHER|||||||0.29|TWO_SIDED||||||Log Rank|||Death||||0.29
72577986|NCT03852537|144683567|SUPERIORITY|||||||0.494|||||||Fisher Exact|||||||0.494
72577987|NCT03852537|144683568|SUPERIORITY|||||||0.666|||||||Fisher Exact|||||||0.666
72577988|NCT03852537|144683569|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.000
72577989|NCT03852537|144683571|SUPERIORITY|||||||0.477|||||||Fisher Exact|||||||0.477
72577990|NCT03852537|144683572|SUPERIORITY|||||||1|||||||Chi-squared|||||||1.000
72577991|NCT03852537|144683573|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.000
72577992|NCT03852537|144683574|SUPERIORITY|||||||0.011|||||||Fisher Exact|||||||0.011
72577993|NCT03852537|144683575|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.000
72577994|NCT03852537|144683577|SUPERIORITY|||||||0.213|||||||Chi-squared|||||||0.213
72577995|NCT03901092|144683598|OTHER||Fleiss' kappa|0.87|||||TWO_SIDED|95.0|0.83|0.91||||||Fleiss' kappa is a statistical measure for assessing the reliability of agreement between a fixed number of raters when assigning categorical ratings to a number of items or classifying items. The primary hypothesis to be tested was that the lower bound of two-sided 95% confidence interval of Fleiss' Kappa will be greater than or equal to 0.6.||0.91|0.83|
72577996|NCT03901092|144683601|OTHER||Fleiss' kappa|0.84|||||TWO_SIDED|95.0|0.8|0.88||||||Fleiss' kappa is a statistical measure for assessing the reliability of agreement between a fixed number of raters when assigning categorical ratings to a number of items or classifying items. The primary hypothesis to be tested was that the lower bound of two-sided 95% confidence interval of Fleiss' Kappa will be greater than or equal to 0.6.||0.88|0.80|
72577997|NCT03901092|144683602|OTHER||Fleiss' kappa|0.9|||||TWO_SIDED|95.0|0.85|0.95||||||Fleiss' kappa is a statistical measure for assessing the reliability of agreement between a fixed number of raters when assigning categorical ratings to a number of items or classifying items. The hypothesis to be tested was that the lower bound of two-sided 95% confidence interval of Fleiss' Kappa will be greater than or equal to 0.6.||0.95|0.85|
72577998|NCT03901092|144683603|OTHER||Cohen's kappa|0.89|||||TWO_SIDED|95.0|0.69|1.0||||||Cohen's kappa statistic for Reader 1||1.00|0.69|
72577999|NCT03901092|144683603|OTHER||Cohen's kappa|0.71|||||TWO_SIDED|95.0|0.41|1.0||||||Cohen's kappa statistic for Reader 2||1.00|0.41|
72578000|NCT03901092|144683603|OTHER||Cohen's kappa|0.6|||||TWO_SIDED|95.0|0.24|0.95||||||Cohen's kappa statistic for Reader 3||0.95|0.24|
72578001|NCT03901092|144683603|OTHER||Cohen's kappa|0.89|||||TWO_SIDED|95.0|0.67|1.0||||||Cohen's kappa statistic for Reader 4||1.00|0.67|
72578002|NCT03901092|144683603|OTHER||Cohen's kappa|0.79|||||TWO_SIDED|95.0|0.52|1.0||||||Cohen's kappa statistic for Reader 5||1.00|0.52|
72578003|NCT00396565|144683634|SUPERIORITY_OR_OTHER||Least squares mean difference|-12.7|STANDARD_ERROR_OF_MEAN|2.26|<|0.0001||95.0|-17.16|-8.25|||ANCOVA|ANCOVA model with treatment as a factor and baseline score as a covariate||||-8.25|-17.16|<0.0001
72578004|NCT00396565|144683635|SUPERIORITY_OR_OTHER||Least squares mean difference|-3.8|STANDARD_ERROR_OF_MEAN|0.68|<|0.0001||95.0|-5.17|-2.51|||ANCOVA|ANCOVA model with treatment as a factor and with baseline score as a covariate.||||-2.51|-5.17|<0.0001
72578005|NCT00396565|144683636|SUPERIORITY_OR_OTHER||Least squares mean difference|-2.5|STANDARD_ERROR_OF_MEAN|0.6|<|0.0001||95.0|-3.71|-1.33|||ANCOVA|ANCOVA model with treatment as a factor and with baseline score as a covariate||||-1.33|-3.71|<0.0001
72578006|NCT00396565|144683637|SUPERIORITY_OR_OTHER||Least squares mean difference|-6.2|STANDARD_ERROR_OF_MEAN|1.21|<|0.0001||95.0|-8.58|-3.8|||ANCOVA|ANCOVA model with treatment as a factor, and with baseline score as a covariate||||-3.80|-8.58|<0.0001
72578007|NCT00396565|144683638|SUPERIORITY_OR_OTHER|||||||0.0007|||||||Fisher Exact|||||||0.0007
72578008|NCT00396565|144683639|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001||95.0|-0.84|-0.34|||ANCOVA|ANCOVA model with treatment as a factor, and baseline score as a covariate||||-0.34|-0.84|<0.0001
72578009|NCT01252277|144683641|SUPERIORITY_OR_OTHER||||||<|0.001||||||No adjustment for multiple comparisons. A priori threshold for statistical significance, p\<0.05.|Wilcoxon (Mann-Whitney)|||||||<0.001
72578010|NCT01252277|144683642|SUPERIORITY_OR_OTHER|||||||0.021|TWO_SIDED|||||No adjustment for multiple comparisons|Wilcoxon (Mann-Whitney)|||||||0.021
72578011|NCT01252277|144683643|SUPERIORITY_OR_OTHER||||||<|0.001||||||No adjustment for multiple comparisons. A priori threshold for statistical significance p\<0.05|Wilcoxon (Mann-Whitney)|||||||<0.001
72578012|NCT01252277|144683644|SUPERIORITY_OR_OTHER|||||||0.48||||||No adjustment for multiple comparisons. A priori threshold for statistical significance, p\<0.05|Wilcoxon (Mann-Whitney)|||||||0.48
72578013|NCT03097991|144683677|SUPERIORITY||Slope|1.86|STANDARD_ERROR_OF_MEAN|1.86||0.32|TWO_SIDED||||||Mixed Models Analysis||Group x Timepoint Effect|||||.32
72578014|NCT03097991|144683677|SUPERIORITY||Slope|-0.84|STANDARD_ERROR_OF_MEAN|1.33||0.53|TWO_SIDED||||||Mixed Models Analysis||Group Effect|||||.53
72578015|NCT03097991|144683678|SUPERIORITY||Slope|-3.04|STANDARD_ERROR_OF_MEAN|1.63||0.07|TWO_SIDED||||||Mixed Models Analysis||Group x Timepoint Effect|||||.07
72410945|NCT01144338|144330268|SUPERIORITY|Superiority test of EQW over Placebo H0: HR ≥ 1 vs. H1: HR \< 1|Hazard Ratio (HR)|0.86||||0.016|TWO_SIDED|95.0|0.77|0.97|||Regression, Cox|||||0.97|0.77|0.016
72410946|NCT01144338|144330269|SUPERIORITY|Superiority test of EQW over Placebo H0: HR ≥ 1 vs. H1: HR \< 1|Hazard Ratio (HR)|0.88||||0.096|TWO_SIDED|95.0|0.76|1.02|||Regression, Cox|||||1.02|0.76|0.096
72410947|NCT01144338|144330270|SUPERIORITY|Superiority test of EQW over Placebo H0: HR ≥ 1 vs. H1: HR \< 1|Hazard Ratio (HR)|0.97||||0.622|TWO_SIDED|95.0|0.85|1.1|||Regression, Cox|||||1.10|0.85|0.622
72410948|NCT01144338|144330271|SUPERIORITY|Superiority test of EQW over Placebo H0: HR ≥ 1 vs. H1: HR \< 1|Hazard Ratio (HR)|0.85||||0.095|TWO_SIDED|95.0|0.7|1.03|||Regression, Cox|||||1.03|0.70|0.095
72543258|NCT01381900|144616804|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-1.43|STANDARD_ERROR_OF_MEAN|0.173|<|0.001|TWO_SIDED|95.0|-1.769|-1.089|||ANCOVA|||||-1.089|-1.769|<0.001
72543259|NCT01381900|144616805|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-2.2|STANDARD_ERROR_OF_MEAN|0.3|<|0.001|TWO_SIDED|95.0|-2.7|-1.6|||ANCOVA|||||-1.6|-2.7|<0.001
72543260|NCT01381900|144616805|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-2.3|STANDARD_ERROR_OF_MEAN|0.3|<|0.001|TWO_SIDED|95.0|-2.9|-1.8|||ANCOVA|||||-1.8|-2.9|<0.001
72543261|NCT01381900|144616806|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.26|||||TWO_SIDED|95.0|2.09|5.09|||Regression, Logistic|||||5.09|2.09|
72543262|NCT01381900|144616806|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.99|||||TWO_SIDED|95.0|2.55|6.27|||Regression, Logistic|||||6.27|2.55|
72410949|NCT01144338|144330272|SUPERIORITY|Superiority test of EQW over Placebo H0: HR ≥ 1 vs. H1: HR \< 1|Hazard Ratio (HR)|1.05||||0.402|TWO_SIDED|95.0|0.94|1.18|||Regression, Cox|||||1.18|0.94|0.402
72410950|NCT01144338|144330273|SUPERIORITY|Superiority test of EQW over Placebo H0: HR ≥ 1 vs. H1: HR \< 1|Hazard Ratio (HR)|0.94||||0.485|TWO_SIDED|95.0|0.78|1.13|||Regression, Cox|||||1.13|0.78|0.485
72410951|NCT01971346|144330307|OTHER|||||||0.38||||||Type III TNF-alpha p-value=0.36. Type III IFN-alpha p-value=0.36. Interaction was not included in this model.|Regression, Linear|||A cumulative score reflecting change in PASI during the course of treatment was calculated and treated as a continuous response variable. Linear modeling was done to determine if change in PASI score was associated with the baseline TNF-alpha signal, baseline IFN-alpha signal and/or an interaction between these two signals.||||0.38
72410952|NCT01971346|144330308|OTHER|||||||0.03||||||Test of Hypotheses for Between subject effect of PASI profile p-value=0.03 Test of Hypotheses for Within subject effect of Time p-value=0.38 Test of Hypotheses for Within subject effect of Time\*PASI profile p-value=0.31|ANOVA|||The strength of the TNF-alpha cytokine signals will be treated as a response variable in a univariate repeated measure analysis of variance, with PASI response profile and time as covariates. Testing if TNF-alpha signals are significantly altered during the course of etanercept therapy and if such changes differ between subjects with different PASI response profiles.||||0.03
72410953|NCT01971346|144330309|OTHER|||||||0.34||||||Test of Hypotheses for Between subject effect of PASI profile p-value=0.34 Test of Hypotheses for Within subject effect of Time p-value=0.73 Test of Hypotheses for Within subject effect of Time\*PASI profile p-value=0.57|ANOVA|||The strength of the IFN-alpha cytokine signals will be treated as a response variable in a univariate repeated measure analysis of variance, with PASI response profile and time as covariates. Testing if IFN-alpha signals are significantly altered during the course of etanercept therapy and if such changes differ between subjects with different PASI response profiles.||||0.34
72410954|NCT03735862|144330312|OTHER|Paired t-Test|||||<|0.001|||||||t-test, 1 sided|||Difference between baseline and follow-up||||<0.001
72410955|NCT03735862|144330313|SUPERIORITY||||||<|0.0001|||||||McNemar|||Difference between baseline and follow-up||||<0.0001
72410956|NCT04122443|144330319|SUPERIORITY||Mean Difference (Final Values)|1.1|||||TWO_SIDED|95.0|0.3|1.9||||||||1.9|0.3|
72410957|NCT04122443|144330320|SUPERIORITY||Mean Difference (Final Values)|13.0|||||TWO_SIDED|95.0|-3.0|29.0||||||||29|-3|
72410958|NCT04122443|144330321|SUPERIORITY||Mean Difference (Final Values)|9.0|||||TWO_SIDED|95.0|-5.0|23.0||||||||23|-5|
72410959|NCT04122443|144330322|SUPERIORITY||Mean Difference (Final Values)|6.0|||||TWO_SIDED|95.0|-10.0|21.0||||||||21|-10|
72543263|NCT01381900|144616807|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.55|||||TWO_SIDED|95.0|1.45|4.48|||Regression, Logistic|||||4.48|1.45|
72543264|NCT01381900|144616807|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.29|||||TWO_SIDED|95.0|1.88|5.75|||Regression, Logistic|||||5.75|1.88|
72543265|NCT02965820|144616836|SUPERIORITY||||||=|0.003|||||||Mixed Models Analysis|||||||=0.0030
72543266|NCT01967888|144616837|SUPERIORITY||t-test|-1.2||||0.542|TWO_SIDED|95.0|-14.3|0.0|||Cochran-Mantel-Haenszel|||||000|-14.3|0.542
72543267|NCT01967888|144616838|SUPERIORITY||least square mean difference|-0.1601778||||0.092|TWO_SIDED|95.0|-0.317803|-0.0025525|||t-test, 2 sided|||||-0.0025525|-0.3178030|0.092
72543268|NCT01967888|144616839|SUPERIORITY||least square mean difference|-0.1178242||||0.161|TWO_SIDED|95.0|-0.287431|0.0517825|||t-test, 2 sided|||||0.0517825|-0.2874310|0.161
72543269|NCT01967888|144616840|SUPERIORITY||least square mean difference|0.0136||||0.846|TWO_SIDED|95.0|-0.0508|0.0781|||t-test, 2 sided|||||0.0781|-0.0508|0.846
72543270|NCT01967888|144616841|SUPERIORITY||least square mean difference|-0.025||||0.817|TWO_SIDED|95.0|-0.0939|0.0689|||t-test, 2 sided|||||0.0689|-0.0939|0.817
72543271|NCT01967888|144616842|SUPERIORITY||least square mean difference|-9.4641||||0.57|TWO_SIDED|95.0|-42.49|23.5618|||Mixed Models Analysis|||||23.5618|-42.4900|0.570
72543272|NCT01967888|144616843|SUPERIORITY||least square mean difference|-22.9454|||=|0.074|TWO_SIDED|95.0|-48.1826|2.2918|||Mixed Models Analysis|||||2.2918|-48.1826|=0.074
72543273|NCT01967888|144616844|SUPERIORITY||least square mean difference|-0.2074|||=|0.358|TWO_SIDED|95.0|-0.6538|0.2389|||Mixed Models Analysis|||||0.2389|-0.6538|=0.358
72543274|NCT01967888|144616845|SUPERIORITY||least square mean difference|-0.277|||=|0.288|TWO_SIDED|95.0|-0.7936|0.2396|||Mixed Models Analysis|||||0.2396|-0.7936|=0.288
72578016|NCT03097991|144683678|SUPERIORITY||Slope|0.54|STANDARD_ERROR_OF_MEAN|1.36||0.69|TWO_SIDED||||||Mixed Models Analysis||||Group Effect|||.69
72578017|NCT03097991|144683679|SUPERIORITY||Slope|2.44|STANDARD_ERROR_OF_MEAN|2.0||0.22|TWO_SIDED||||||Mixed Models Analysis||Group x Timepoint Effect|||||.22
72578018|NCT03097991|144683679|SUPERIORITY||Slope|0.84|STANDARD_ERROR_OF_MEAN|1.33||0.53|TWO_SIDED||||||Mixed Models Analysis||Group effect|||||.53
72578019|NCT03097991|144683680|SUPERIORITY||Slope|-1.73|STANDARD_ERROR_OF_MEAN|1.76||0.33|TWO_SIDED||||||Mixed Models Analysis||Group x Timepoint Effect|||||.33
72578020|NCT03097991|144683680|SUPERIORITY||Slope|0.54|STANDARD_ERROR_OF_MEAN|1.36||0.69|TWO_SIDED||||||Mixed Models Analysis||Group Effect|||||.69
72578021|NCT03097991|144683681|SUPERIORITY||Slope|0.04|STANDARD_ERROR_OF_MEAN|0.17||0.81|TWO_SIDED||||||Mixed Models Analysis||Group Effect|||||.81
72578022|NCT03097991|144683681|SUPERIORITY||Slope|0.01|STANDARD_ERROR_OF_MEAN|0.02||0.56|TWO_SIDED||||||Mixed Models Analysis||Group x Timepoint Effect|||||.56
72578023|NCT03097991|144683682|SUPERIORITY||Slope|0.04|STANDARD_ERROR_OF_MEAN|0.13||0.77|TWO_SIDED||||||Mixed Models Analysis||Group Effect|||||.77
72578024|NCT03097991|144683682|SUPERIORITY||Slope|-0.003|STANDARD_ERROR_OF_MEAN|0.02||0.85|TWO_SIDED||||||Mixed Models Analysis||Group x Timepoint Effect|||||.85
72578025|NCT03097991|144683683|SUPERIORITY||Slope|0.01|STANDARD_ERROR_OF_MEAN|0.02||0.56|TWO_SIDED||||||Mixed Models Analysis||Group x Timepoint Effect|||||.56
72578026|NCT03097991|144683683|SUPERIORITY||Slope|0.04|STANDARD_ERROR_OF_MEAN|0.17||0.81|TWO_SIDED||||||Mixed Models Analysis||Group Effect|||||.81
72578027|NCT03097991|144683684|SUPERIORITY||Slope|-0.003|STANDARD_ERROR_OF_MEAN|0.02||0.85|TWO_SIDED||||||Mixed Models Analysis||Group x Timepoint effect|||||.85
72578028|NCT03097991|144683684|SUPERIORITY||Slope|0.04|STANDARD_ERROR_OF_MEAN|0.13||0.77|TWO_SIDED||||||Mixed Models Analysis||Group Effect|||||.77
72578029|NCT03097991|144683685|SUPERIORITY||Slope|21.01|STANDARD_ERROR_OF_MEAN|5.91|<|0.001|TWO_SIDED||||||Mixed Models Analysis||Group x Timepoint|||||<.001
72578030|NCT03097991|144683685|SUPERIORITY||Slope|2.98|STANDARD_ERROR_OF_MEAN|4.75|<|0.001|TWO_SIDED||||||Mixed Models Analysis||Group|||||<.001
72578031|NCT03097991|144683686|SUPERIORITY||Slope|0.68|STANDARD_ERROR_OF_MEAN|0.49|<|0.05|TWO_SIDED||||||Mixed Models Analysis|linear mixed effects|Group|||||<.05
72578032|NCT03097991|144683686|SUPERIORITY||Slope|0.26|STANDARD_ERROR_OF_MEAN|0.6|<|0.05|TWO_SIDED||||||Mixed Models Analysis||Group x Timepoint|||||<.05
72578033|NCT03097991|144683687|SUPERIORITY||Slope|3.52|STANDARD_ERROR_OF_MEAN|4.14||0.39|TWO_SIDED||||||Mixed Models Analysis||Group|"We analyzed the CTS scales Psychological Aggression and Physical Assault. Inspection of the latter in the raw data and descriptives showed extremely consistent selection of the lowest value of the scale (no incidents of assault) across all respondents, so we did not conduct inferential tests."||||.39
72578034|NCT03097991|144683687|SUPERIORITY||Slope|-13.38|STANDARD_ERROR_OF_MEAN|4.86|<|0.005|TWO_SIDED||||||Mixed Models Analysis||Group x Time|||||<.005
72578035|NCT03097991|144683688|SUPERIORITY||Slope|-1.17|STANDARD_ERROR_OF_MEAN|1.25||0.24|TWO_SIDED||||||Mixed Models Analysis||Group|||||.24
72578036|NCT03097991|144683688|EQUIVALENCE|ANOVA found a main effect of group, F(1, 155) = 6.85, p \< .05, η2G = .04.|Mean Difference (Final Values)|6.85|||<|0.05|TWO_SIDED||||||ANOVA||Group|||||<.05
72578037|NCT03097991|144683689|SUPERIORITY||Slope|-2.53|STANDARD_ERROR_OF_MEAN|1.04||0.02|TWO_SIDED||||||Mixed Models Analysis||Parent x Group|||||.02
72578038|NCT03097991|144683689|SUPERIORITY||Slope|0.45|STANDARD_ERROR_OF_MEAN|0.78||0.56|TWO_SIDED||||||Mixed Models Analysis||Group|||||.56
72578039|NCT03097991|144683690|SUPERIORITY||Slope|0.94|STANDARD_ERROR_OF_MEAN|0.9||0.3|TWO_SIDED||||||Mixed Models Analysis||Parent x Group|||||.30
72578040|NCT03097991|144683690|SUPERIORITY||Slope|-0.62|STANDARD_ERROR_OF_MEAN|0.67||0.36|TWO_SIDED||||||Mixed Models Analysis||Group|||||.36
72543275|NCT01967888|144616846|SUPERIORITY||least square mean difference|0.09716|||=|0.98|TWO_SIDED|95.0|-7.41834|7.61266|||Mixed Models Analysis|||||7.61266|-7.41834|=0.980
72543276|NCT01967888|144616847|SUPERIORITY||least square mean difference|1.07617|||=|0.785|TWO_SIDED|95.0|-6.76562|8.91796|||Mixed Models Analysis|||||8.91796|-6.76562|=0.785
72543277|NCT01967888|144616848|SUPERIORITY|||||||0.176|||||||Wilcoxon (Mann-Whitney)|||||||0.176
72543278|NCT01967888|144616849|SUPERIORITY|||||||0.403|||||||Wilcoxon (Mann-Whitney)|||||||0.403
72543279|NCT01967888|144616850|SUPERIORITY||Treatment effect|2.1||||0.842|TWO_SIDED|95.0|-18.2|22.33|||Chi-squared|||||22.33|-18.20|0.842
72543280|NCT01967888|144616851|SUPERIORITY||Hazard Ratio (HR)|3.21||||0.339|TWO_SIDED|95.0|0.29|34.97|||Anderson-Gill model|||||34.97|0.29|0.339
72543281|NCT01967888|144616852|SUPERIORITY||Treatment effect|5.0||||0.64|TWO_SIDED|95.0|-15.91|25.93|||Chi-squared|||||25.93|-15.91|0.640
72543282|NCT01967888|144616858|SUPERIORITY|||||||0.448|||||||Wilcoxon rank-sum test|||||||0.448
72410960|NCT03149328|144330330|EQUIVALENCE|Based on a power analysis for an ANCOVA comparing 2 groups using the area under the curve approach, a total sample 459 (655 x 70% response rate) will provide 80% power to detect effect sizes (f2) of moderate magnitude at a statistical significance level of 0.05 (e.g., f2 ranging from 0.15 for 1 covariate to 0.19 for 10 covariates).||||||0.3||||||Threshold for statistical significance was p=0.05|ANCOVA|||We will examine the trajectories of outcome measures for patients in the comparator and intervention groups. The area under the curve (AUC) will be calculated for each trajectory during the period that the patient is participating to create a summary score. Null Hypothesis is that both groups are the same.||||0.30
72410961|NCT03149328|144330331|EQUIVALENCE|Based on a power analysis for an ANCOVA comparing 2 groups using the area under the curve approach, a total sample 459 (655 x 70% response rate) will provide 80% power to detect effect sizes (f2) of moderate magnitude at a statistical significance level of 0.05 (e.g., f2 ranging from 0.15 for 1 covariate to 0.19 for 10 covariates).||||||0.28|||||||ANCOVA|||We will examine the trajectories of outcome measures for patients in the comparator and intervention groups. The area under the curve (AUC) will be calculated for each trajectory during the period that the patient is participating to create a summary score. Null Hypothesis = both groups are the same||||0.28
72410962|NCT03149328|144330332|EQUIVALENCE|Based on a power analysis for an ANCOVA comparing 2 groups using the area under the curve approach, a total sample 459 (655 x 70% response rate) will provide 80% power to detect effect sizes (f2) of moderate magnitude at a statistical significance level of 0.05 (e.g., f2 ranging from 0.15 for 1 covariate to 0.19 for 10 covariates)||||||0.22||||||Threshold for statistical Significance was p = 0.05|ANCOVA|||"Analysis of covariance (ANCOVA) will be used as the method of analysis to compare outcomes of both groups while controlling for within- and between-group differences, such as comorbidities, gender, age and dialysis type. ANCOVA is necessary to control for baseline and potential confounders.~Null hypotheses = No difference between groups in the number of hospitalizations"||||0.22
72410963|NCT03149328|144330332|EQUIVALENCE|Based on a power analysis for an ANCOVA comparing 2 groups using the area under the curve approach, a total sample 459 (655 x 70% response rate) will provide 80% power to detect effect sizes (f2) of moderate magnitude at a statistical significance level of 0.05 (e.g., f2 ranging from 0.15 for 1 covariate to 0.19 for 10 covariates)||||||0.1||||||Threshold for statistical Significance was p = 0.05|ANCOVA|||"Analysis of covariance (ANCOVA) will be used as the method of analysis to compare outcomes of both groups while controlling for within- and between-group differences, such as comorbidities, gender, age and dialysis type. ANCOVA is necessary to control for baseline and potential confounders.~Null hypotheses = No difference between groups in the number of emergency room visits"||||0.10
72410964|NCT03149328|144330333|EQUIVALENCE|Based on a power analysis for an ANCOVA comparing 2 groups using the area under the curve approach, a total sample 459 (655 x 70% response rate) will provide 80% power to detect effect sizes (f2) of moderate magnitude at a statistical significance level of 0.05 (e.g., f2 ranging from 0.15 for 1 covariate to 0.19 for 10 covariates)||||||0.18||||||Threshold for statistical significance p = 0.05|ANCOVA|||"Analysis of covariance (ANCOVA) will be used as the method of analysis to compare outcomes of both groups while controlling for within- and between-group differences, such as comorbidities, gender, age and dialysis type. ANCOVA is necessary to control for baseline and potential confounders.~Null hypotheses = No difference between groups"||||0.18
72410965|NCT03149328|144330334|EQUIVALENCE|Based on a power analysis for an ANCOVA comparing 2 groups using the area under the curve approach, a total sample 459 (655 x 70% response rate) will provide 80% power to detect effect sizes (f2) of moderate magnitude at a statistical significance level of 0.05 (e.g., f2 ranging from 0.15 for 1 covariate to 0.19 for 10 covariates)||||||0.79||||||Threshold for statistical significance p = 0.05|ANCOVA|||"Analysis of covariance (ANCOVA) will be used as the method of analysis to compare outcomes of both groups while controlling for within- and between-group differences, such as comorbidities, gender, age and dialysis type. ANCOVA is necessary to control for baseline and potential confounders.~Null hypotheses = No difference between groups"||||0.79
72543283|NCT01967888|144616859|SUPERIORITY|||||||0.91|||||||Wilcoxon rank-sum test|||||||0.910
72410966|NCT03149328|144330335|EQUIVALENCE|Based on a power analysis for an ANCOVA comparing 2 groups using the area under the curve approach, a total sample 459 (655 x 70% response rate) will provide 80% power to detect effect sizes (f2) of moderate magnitude at a statistical significance level of 0.05 (e.g., f2 ranging from 0.15 for 1 covariate to 0.19 for 10 covariates)|||||<|0.001||||||Threshold for statistical significance p = 0.05|ANCOVA|||"Analysis of covariance (ANCOVA) will be used as the method of analysis to compare outcomes of both groups while controlling for within- and between-group differences, such as comorbidities, gender, age and dialysis type. ANCOVA is necessary to control for baseline and potential confounders.~Null hypotheses = No difference between groups"||||<0.001
72410967|NCT01306617|144330348|SUPERIORITY_OR_OTHER|||||||0.547|TWO_SIDED||||||Regression, Logistic|Arm, baseline log10 HCV RNA level (\<=800,000, \>800,000), IL-28B genotype (CC, non-CC), and HCV subgenotype (1a, 1b) were used as strata.||For the percentage of subjects with HCV RNA suppressed below the LLOD from Week 4 through Week 12, if it was assumed that 60% of subjects would be successfully suppressed from Week 4 through Week 12, then 20 subjects in arm 1 would give a 95% 2-sided confidence interval (CI) of (38.5%, 81.5%), 10 subjects in arm 2 would give a 95% CI of (29.6%, 90.4%), and 15 subjects in arm 3 would give a 95% CI of (35.2%, 84.8%) for the percentage of subjects suppressed using the binomial exact method.||||0.547
72410968|NCT01306617|144330348|SUPERIORITY_OR_OTHER|||||||0.207|TWO_SIDED||||||Regression, Logistic|Arm, baseline log10 HCV RNA level (\<=800,000, \>800,000), IL-28B genotype (CC, non-CC), and HCV subgenotype (1a, 1b) were used as strata.||||||0.207
72410969|NCT01306617|144330349|SUPERIORITY_OR_OTHER|||||||0.061|TWO_SIDED||||||Cochran-Mantel-Haenszel|Arm, baseline log10 HCV RNA level (\<=800,000, \>800,000), IL-28B genotype (CC, non-CC), and HCV subgenotype (1a, 1b) were used as strata.||||||0.061
72410970|NCT01306617|144330350|SUPERIORITY_OR_OTHER|||||||0.061|TWO_SIDED||||||Cochran-Mantel-Haenszel|Arm, baseline log10 HCV RNA level (\<=800,000, \>800,000), IL-28B genotype (CC, non-CC), and HCV subgenotype (1a, 1b) were used as strata.||||||0.061
72543284|NCT01967888|144616860|SUPERIORITY|||||||1|||||||Wilcoxon rank-sum test|||||||1.000
72543285|NCT01967888|144616865|SUPERIORITY||least square mean difference|31.3491|||=|0.5018|TWO_SIDED|95.0|-60.998|123.7|||Mixed Models Analysis|||||123.70|-60.9980|=0.5018
72410971|NCT01306617|144330350|SUPERIORITY_OR_OTHER|||||||0.375|TWO_SIDED||||||Cochran-Mantel-Haenszel|Arm, baseline log10 HCV RNA level (\<=800,000, \>800,000), IL-28B genotype (CC, non-CC), and HCV subgenotype (1a, 1b) were used as strata.||||||0.375
72410972|NCT01306617|144330351|SUPERIORITY_OR_OTHER|||||||0.312|TWO_SIDED||||||Cochran-Mantel-Haenszel|Arm, baseline log10 HCV RNA level (\<=800,000, \>800,000), IL-28B genotype (CC, non-CC), and HCV subgenotype (1a, 1b) were used as strata.||||||0.312
72410973|NCT01306617|144330351|SUPERIORITY_OR_OTHER|||||||0.012|TWO_SIDED||||||Cochran-Mantel-Haenszel|Arm, baseline log10 HCV RNA level (\<=800,000, \>800,000), IL-28B genotype (CC, non-CC), and HCV subgenotype (1a, 1b) were used as strata.||||||0.012
72410974|NCT01306617|144330352|SUPERIORITY_OR_OTHER|||||||0.312|TWO_SIDED||||||Cochran-Mantel-Haenszel|Arm, baseline log10 HCV RNA level (\<=800,000, \>800,000), IL-28B genotype (CC, non-CC), and HCV subgenotype (1a, 1b) were used as strata.||||||0.312
72410975|NCT01306617|144330352|SUPERIORITY_OR_OTHER|||||||0.012|TWO_SIDED||||||Cochran-Mantel-Haenszel|Arm, baseline log10 HCV RNA level (\<=800,000, \>800,000), IL-28B genotype (CC, non-CC), and HCV subgenotype (1a, 1b) were used as strata.||||||0.012
72543286|NCT01967888|144616866|SUPERIORITY||Least square mean difference|23.5454|||=|0.4537|TWO_SIDED|95.0|-38.6619|85.7528|||Mixed Models Analysis|||||85.7528|-38.6619|=0.4537
72543287|NCT01859325|144616911|SUPERIORITY||Median Difference (Final Values)|-0.36||||0.406|TWO_SIDED|95.0|-1.41|0.67|||Wilcoxon (Mann-Whitney)|||Samples size based on published data on populations of early treated patients undergoing ART interruption. The power based on a 2-sample t-test with a 2-tailed alpha of .05 and a total sample size of 30 is approximately 91% to detect a 1.25 log10 reduction in the rebound plasma viremia between vaccine and placebo groups.||0.67|-1.41|0.406
72578041|NCT03097991|144683691|SUPERIORITY||Slope|-0.75|STANDARD_ERROR_OF_MEAN|0.55||0.17|TWO_SIDED||||||Mixed Models Analysis||Parent x Group|||||.17
72410976|NCT01306617|144330353|SUPERIORITY_OR_OTHER|||||||0.395|TWO_SIDED||||||Log Rank|||||||0.395
72410977|NCT01306617|144330353|SUPERIORITY_OR_OTHER|||||||0.01|TWO_SIDED||||||Log Rank|||||||0.010
72410978|NCT01306617|144330354|SUPERIORITY_OR_OTHER|||||||0.048|TWO_SIDED||||||Log Rank|||||||0.048
72410979|NCT01130740|144330360|SUPERIORITY_OR_OTHER|||||||0.158|TWO_SIDED||||||Mixed Models Analysis|||This is a comparison of 6-month outcomes between the two study groups. (Primary comparison is for 12 months.)||||0.158
72410980|NCT01130740|144330360|SUPERIORITY_OR_OTHER|||||||0.008|TWO_SIDED||||||Mixed Models Analysis|||This is the 12-month comparison between the 2 study groups, which is the primary study analysis.||||0.008
72410981|NCT01130740|144330361|SUPERIORITY_OR_OTHER|||||||0.274|TWO_SIDED||||||Mixed Models Analysis|||This is the between-group 12-month comparison.||||0.274
72410982|NCT01130740|144330362|SUPERIORITY_OR_OTHER|||||||0.177|TWO_SIDED||||||Mixed Models Analysis|||||||0.177
72410983|NCT03403634|144330363|SUPERIORITY|||||||0.046||||||significance level = 0.05|t-test, 1 sided|df = 11. one-sided as post treatment increases were of interest. the fold changes were log-transformed prior to inferences.||||||0.046
72410984|NCT03223298|144330404|SUPERIORITY|||||||0.8|||||||Wilcoxon (Mann-Whitney)|||3-month mean change (from pre-op) in Jaw Pain compared between the Botox group and Placebo group.||||0.80
72410985|NCT03223298|144330405|SUPERIORITY|||||||0.5|||||||Wilcoxon (Mann-Whitney)|||3-month mean Jaw Function Limitation Scale score compared between Botox group and placebo group.||||0.50
72410986|NCT03223298|144330406|SUPERIORITY|||||||0.3|||||||Wilcoxon (Mann-Whitney)|||Change in MIO with Pain at 3-months post-intervention compared between Botox group and Placebo group.||||0.30
72410987|NCT03223298|144330406|SUPERIORITY|||||||0.5|||||||Wilcoxon (Mann-Whitney)|||Change in MIO without Pain at 3-months post-intervention compared between Botox group and Placebo group.||||0.50
72410988|NCT03223298|144330407|SUPERIORITY|||||||0.4|||||||Wilcoxon (Mann-Whitney)|||Mean change at 3 months post intervention - General Health Score, compared between Botox group and Placebo group.||||0.40
72410989|NCT01627249|144330432|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.5|||<|0.001|TWO_SIDED|95.0|1.4|5.7|||ANCOVA||Reported P-values have been adjusted for multiple treatment group comparisons.|Aflibercept vs. Bevacizumab||5.7|1.4|<0.001
72410990|NCT01627249|144330432|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.1||||0.034|TWO_SIDED|95.0|0.1|4.2|||ANCOVA||Reported P-values have been adjusted for multiple treatment group comparisons.|Aflibercept vs. Ranibizumab||4.2|0.1|0.034
72410991|NCT01627249|144330432|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.4||||0.12|TWO_SIDED|95.0|-0.4|3.2|||ANCOVA||Reported P-values have been adjusted for multiple treatment group comparisons.|Ranibizumab vs. Bevacizumab||3.2|-0.4|0.12
72410992|NCT01627249|144330433|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-69.9|||<|0.001|TWO_SIDED|95.0|-91.1|-48.6|||ANCOVA||Reported P-values have been adjusted for multiple treatment group comparisons.|Aflibercept vs Bevacizumab||-48.6|-91.1|<0.001
72410993|NCT01627249|144330433|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-18.6||||0.036|TWO_SIDED|95.0|-36.0|-1.2|||ANCOVA||Reported P-values have been adjusted for multiple treatment group comparisons.|Aflibercept vs Ranibizumab||-1.2|-36|0.036
72410994|NCT01627249|144330433|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-51.2|||<|0.001|TWO_SIDED|95.0|-71.2|-31.3|||ANCOVA||Reported P-values have been adjusted for multiple treatment group comparisons.|Ranibizumab vs Bevacizumab||-31.3|-71.2|<0.001
72410995|NCT01627249|144330434|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|6.5||||0.001|TWO_SIDED|95.0|2.9|10.1|||ANCOVA||Reported P-values have been adjusted for multiple treatment group comparisons.|Aflibercept vs. Bevacizumab||10.1|2.9|0.001
72410996|NCT01627249|144330434|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.7||||0.0031|TWO_SIDED|95.0|1.4|8.0|||ANCOVA||Reported P-values have been adjusted for multiple treatment group comparisons.|Aflibercept vs. Ranibizumab||8.0|1.4|0.0031
72543288|NCT03840135|144616922|SUPERIORITY||Mean Difference (Final Values)|-0.22|||<|0.05|TWO_SIDED|95.0|-0.6|0.16|||t-test, 2 sided|||The value of δ = -0.52 days was considered as the boundary of superiority. The end of the fever period is considered to have an axillary body temperature of ≤36.9 ° C in two consecutive measurements (morning-evening / evening-morning).||0.16|-0.6|<0.05
72578042|NCT03097991|144683691|SUPERIORITY||Slope|0.33|STANDARD_ERROR_OF_MEAN|0.47||0.48|TWO_SIDED||||||Mixed Models Analysis||Group|||||.48
72578043|NCT03097991|144683692|SUPERIORITY||Slope|1.15|STANDARD_ERROR_OF_MEAN|7.34||0.88|TWO_SIDED||||||Mixed Models Analysis||Group|||||.88
72578044|NCT03097991|144683692|SUPERIORITY||Slope|7.94|STANDARD_ERROR_OF_MEAN|9.0||0.38|TWO_SIDED||||||Mixed Models Analysis||Group x Time|||||.38
72410997|NCT01627249|144330434|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.8||||0.21|TWO_SIDED|95.0|-1.1|4.8|||ANCOVA||Reported P-values have been adjusted for multiple treatment group comparisons.|Ranibizumab vs Bevacizumab||4.8|-1.1|0.21
72410998|NCT01627249|144330435|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.7||||0.69|TWO_SIDED|95.0|-1.3|2.7|||ANCOVA||Reported P-values have been adjusted for multiple treatment group comparisons.|Aflibercept vs Bevacizumab||2.7|-1.3|0.69
72410999|NCT01627249|144330435|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.4||||0.69|TWO_SIDED|95.0|-2.3|1.5|||ANCOVA||Reported P-values have been adjusted for multiple treatment group comparisons.|Aflibercept vs Ranibizumab||1.5|-2.3|0.69
72411000|NCT01627249|144330435|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.1||||0.69|TWO_SIDED|95.0|-0.9|3.1|||ANCOVA||Reported P-values have been adjusted for multiple treatment group comparisons.|Ranibizumab vs Bevacizumab||3.1|-0.9|0.69
72411001|NCT01138124|144330483|SUPERIORITY_OR_OTHER||Unadjusted Odds Ratio|2.04|||<|0.0001|TWO_SIDED|95.0|1.51|2.75|||Conditional Logistic Regression||"Comparison: Ever (without 2 year lag) and Never (without 2 year lag)."|||2.75|1.51|<0.0001
72411002|NCT01138124|144330483|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.82||||0.0001|TWO_SIDED|95.0|1.34|2.46|||Conditional Logistic Regression||"Comparison: Ever (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, chronic pancreatitis, neuropathic pain, epilepsy."|||2.46|1.34|0.0001
72411003|NCT01138124|144330483|SUPERIORITY_OR_OTHER||Unadjusted Odds Ratio|1.52||||0.0627|TWO_SIDED|95.0|0.98|2.36|||Conditional Logistic Regression||"Comparison: Ever (with 2 year lag) and Never (with 2 year lag)."|||2.36|0.98|0.0627
72411004|NCT01138124|144330483|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.33||||0.2183|TWO_SIDED|95.0|0.85|2.08|||Conditional Logistic Regression||"Comparison: Ever (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, chronic pancreatitis, neuropathic pain, epilepsy."|||2.08|0.85|0.2183
72543289|NCT03840135|144616923|SUPERIORITY||||||<|0.05|||||||χ2 Pearson criterion|||||||<0.05
72329456|NCT03037476|144184382|OTHER|General Linear Model|Slope|-0.001||||0.999|TWO_SIDED|95.0|-2.005|2.003|||Mixed Models Analysis|Negative Binomial Regression||Change in Past 3 Month Heroin Use from Baseline to 6 Month Followup||2.003|-2.005|.999
72543290|NCT03840135|144616924|SUPERIORITY||||||<|0.05|||||||χ2 Pearson criterion|||||||<0.05
72543291|NCT03840135|144616925|SUPERIORITY||||||<|0.05|||||||χ2 Pearson criterion|||||||<0.05
72543292|NCT03840135|144616926|SUPERIORITY||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
72543293|NCT03840135|144616927|SUPERIORITY||||||<|0.05|||||||χ2 Pearson criterion|||||||<0.05
72543294|NCT03840135|144616928|SUPERIORITY||||||<|0.05|||||||χ2 Pearson criterion|||||||<0.05
72543295|NCT03840135|144616931|SUPERIORITY||||||<|0.05|||||||Fisher Exact|||||||<0.05
72543296|NCT03840135|144616932|SUPERIORITY||||||<|0.05|||||||Chi-squared|||||||<0.05
72578045|NCT03097991|144683693|SUPERIORITY||Slope|-1.89|STANDARD_ERROR_OF_MEAN|1.05||0.07|TWO_SIDED||||||Mixed Models Analysis||Parent x Group|||||.07
72578046|NCT03097991|144683693|SUPERIORITY||Slope|2.52|STANDARD_ERROR_OF_MEAN|0.74|<|0.001|TWO_SIDED||||||Mixed Models Analysis||Group|||||<.001
72578047|NCT03097991|144683694|SUPERIORITY||Slope|-0.04|STANDARD_ERROR_OF_MEAN|0.38||0.92|TWO_SIDED||||||Mixed Models Analysis||Group|||||.92
72578048|NCT03097991|144683694|SUPERIORITY||Slope|1.12|STANDARD_ERROR_OF_MEAN|0.57||0.05|TWO_SIDED||||||Mixed Models Analysis||Group x Timepoint|||||.05
72578049|NCT03097991|144683695|SUPERIORITY||Slope|0.11|STANDARD_ERROR_OF_MEAN|0.47||0.81|TWO_SIDED||||||Mixed Models Analysis||Group|||||.81
72578050|NCT03097991|144683695|SUPERIORITY||Slope|-0.67|STANDARD_ERROR_OF_MEAN|0.7||0.34|TWO_SIDED||||||Mixed Models Analysis||Group x Timepoint|||||.34
72578051|NCT03097991|144683696|SUPERIORITY||Slope|-0.1|STANDARD_ERROR_OF_MEAN|0.33||0.76|TWO_SIDED||||||Mixed Models Analysis||Group|||||.76
72578052|NCT03097991|144683696|SUPERIORITY||Slope|0.31|STANDARD_ERROR_OF_MEAN|0.49||0.53|TWO_SIDED||||||Mixed Models Analysis||Group x Timepoint|||||.53
72578053|NCT03097991|144683697|SUPERIORITY||Slope|-0.02|STANDARD_ERROR_OF_MEAN|0.16||0.88|TWO_SIDED||||||Mixed Models Analysis||Group|||||.88
72578054|NCT03097991|144683697|SUPERIORITY||Slope|0.01|STANDARD_ERROR_OF_MEAN|0.23||0.95|TWO_SIDED||||||Mixed Models Analysis||Group x Timepoint|||||.95
72578055|NCT03097991|144683698|SUPERIORITY||Slope|0.82|STANDARD_ERROR_OF_MEAN|1.13||0.47|TWO_SIDED||||||Mixed Models Analysis||Group x Timepoint|||||.47
72578056|NCT03097991|144683698|SUPERIORITY||Slope|-1.68|STANDARD_ERROR_OF_MEAN|0.93||0.07|TWO_SIDED||||||Mixed Models Analysis||Group|||||.07
72578057|NCT03097991|144683699|SUPERIORITY||Slope|0.54|STANDARD_ERROR_OF_MEAN|1.32||0.68|TWO_SIDED||||||Mixed Models Analysis||Group x Timepoint|||||.68
72578058|NCT03097991|144683699|SUPERIORITY||Slope|-1.68|STANDARD_ERROR_OF_MEAN|0.93||0.07|TWO_SIDED||||||Mixed Models Analysis||Group|||||.07
72578059|NCT03097991|144683700|SUPERIORITY||Slope|-0.85|STANDARD_ERROR_OF_MEAN|1.9||0.65|TWO_SIDED||||||Mixed Models Analysis||Group|||||.65
72578060|NCT03097991|144683700|SUPERIORITY||Slope|-1.65|STANDARD_ERROR_OF_MEAN|2.44||0.5|TWO_SIDED||||||Mixed Models Analysis||Group x Timepoint|||||.50
72578061|NCT03097991|144683701|SUPERIORITY||Slope|0.92|STANDARD_ERROR_OF_MEAN|1.3||0.48|TWO_SIDED||||||Mixed Models Analysis||Group|||||.48
72578062|NCT03097991|144683701|SUPERIORITY||Slope|-1.92|STANDARD_ERROR_OF_MEAN|1.72||0.27|TWO_SIDED||||||Mixed Models Analysis||Group x Timepoint|||||.27
72578063|NCT03097991|144683702|SUPERIORITY||Slope|-1.15|STANDARD_ERROR_OF_MEAN|1.22||0.01|TWO_SIDED||||||Mixed Models Analysis||Group|||||.01
72578064|NCT03097991|144683702|SUPERIORITY||Slope|1.08|STANDARD_ERROR_OF_MEAN|1.96||0.58|TWO_SIDED||||||Mixed Models Analysis||Group x Timepoint|||||.58
72578065|NCT02006732|144683705|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.299|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001|TWO_SIDED|95.0|0.261|0.336|||Mixed Effects Model for Repeated Measure|||||0.336|0.261|<0.0001
72578066|NCT02006732|144683705|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.105|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001|TWO_SIDED|95.0|0.069|0.141|||Mixed Effects Model for Repeated Measure|||||0.141|0.069|<0.0001
72578067|NCT02006732|144683705|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.284|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001|TWO_SIDED|95.0|0.246|0.323|||Mixed Effects Model for Repeated Measure|||||0.323|0.246|<0.0001
72578068|NCT02006732|144683705|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.091|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001|TWO_SIDED|95.0|0.053|0.128|||Mixed Effects Model for Repeated Measure|||||0.128|0.053|<0.0001
72578069|NCT02006732|144683705|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.194|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001|TWO_SIDED|95.0|0.156|0.232|||Mixed Effects Model for Repeated Measure|||||0.232|0.156|<0.0001
72578070|NCT02006732|144683705|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.014|STANDARD_ERROR_OF_MEAN|0.019||0.4499|TWO_SIDED|95.0|-0.023|0.051|||Mixed Effects Model for Repeated Measure|||||0.051|-0.023|0.4499
72578071|NCT02006732|144683706|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.166|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001|TWO_SIDED|95.0|0.129|0.203|||Mixed Effects Model for Repeated Measure|||||0.203|0.129|<0.0001
72578072|NCT02006732|144683706|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.039|STANDARD_ERROR_OF_MEAN|0.019||0.0395|TWO_SIDED|95.0|0.002|0.076|||Mixed Effects Model for Repeated Measure|||||0.076|0.002|0.0395
72578073|NCT02006732|144683706|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.169|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001|TWO_SIDED|95.0|0.132|0.207|||Mixed Effects Model for Repeated Measure|||||0.207|0.132|<0.0001
72578074|NCT02006732|144683706|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.042|STANDARD_ERROR_OF_MEAN|0.019||0.0269|TWO_SIDED|95.0|0.005|0.079|||Mixed Effects Model for Repeated Measure|||||0.079|0.005|0.0269
72578075|NCT02006732|144683706|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.127|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001|TWO_SIDED|95.0|0.09|0.165|||Mixed Effects Model for Repeated Measure|||||0.165|0.090|<0.0001
72578076|NCT02006732|144683706|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.003|STANDARD_ERROR_OF_MEAN|0.019||0.8669|TWO_SIDED|95.0|-0.04|0.034|||Mixed Effects Model for Repeated Measure|||||0.034|-0.040|0.8669
72578077|NCT02006732|144683707|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.564|STANDARD_ERROR_OF_MEAN|0.986|<|0.0001|TWO_SIDED|95.0|-6.499|-2.629|||Mixed Effects Model for Repeated Measure|||||-2.629|-6.499|<0.0001
72578078|NCT02006732|144683707|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.717|STANDARD_ERROR_OF_MEAN|0.974||0.078|TWO_SIDED|95.0|-3.628|0.193|||Mixed Effects Model for Repeated Measure|||||0.193|-3.628|0.0780
72578079|NCT02006732|144683707|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.666|STANDARD_ERROR_OF_MEAN|0.991||0.0002|TWO_SIDED|95.0|-5.611|-1.721|||Mixed Effects Model for Repeated Measure|||||-1.721|-5.611|0.0002
72578080|NCT02006732|144683707|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.82|STANDARD_ERROR_OF_MEAN|0.979||0.4028|TWO_SIDED|95.0|-2.741|1.102|||Mixed Effects Model for Repeated Measure|||||1.102|-2.741|0.4028
72578081|NCT02006732|144683707|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.846|STANDARD_ERROR_OF_MEAN|0.993||0.0042|TWO_SIDED|95.0|-4.796|-0.897|||Mixed Effects Model for Repeated Measure|||||-0.897|-4.796|0.0042
72578082|NCT02006732|144683707|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.898|STANDARD_ERROR_OF_MEAN|0.971||0.3555|TWO_SIDED|95.0|-2.804|1.008|||Mixed Effects Model for Repeated Measure|||||1.008|-2.804|0.3555
72578083|NCT02006732|144683708|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.668|STANDARD_ERROR_OF_MEAN|0.71|<|0.0001|TWO_SIDED|95.0|-6.06|-3.276|||Mixed Effects Model for Repeated Measure|||||-3.276|-6.060|<0.0001
72578084|NCT02006732|144683708|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.097|STANDARD_ERROR_OF_MEAN|0.701||0.0028|TWO_SIDED|95.0|-3.471|-0.723|||Mixed Effects Model for Repeated Measure|||||-0.723|-3.471|0.0028
72578085|NCT02006732|144683708|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.846|STANDARD_ERROR_OF_MEAN|0.711|<|0.0001|TWO_SIDED|95.0|-5.24|-2.451|||Mixed Effects Model for Repeated Measure|||||-2.451|-5.240|<0.0001
72578086|NCT02006732|144683708|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.274|STANDARD_ERROR_OF_MEAN|0.702||0.0696|TWO_SIDED|95.0|-2.651|0.102|||Mixed Effects Model for Repeated Measure|||||0.102|-2.651|0.0696
72578087|NCT02006732|144683708|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.571|STANDARD_ERROR_OF_MEAN|0.714||0.0003|TWO_SIDED|95.0|-3.971|-1.171|||Mixed Effects Model for Repeated Measure|||||-1.171|-3.971|0.0003
72578088|NCT02006732|144683708|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.822|STANDARD_ERROR_OF_MEAN|0.698||0.2387|TWO_SIDED|95.0|-2.191|0.546|||Mixed Effects Model for Repeated Measure|||||0.546|-2.191|0.2387
72578089|NCT02006732|144683709|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.252|STANDARD_ERROR_OF_MEAN|0.033|<|0.0001|TWO_SIDED|95.0|0.187|0.317|||Mixed Effects Model for Repeated Measure|||||0.317|0.187|<0.0001
72578090|NCT02006732|144683709|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.061|STANDARD_ERROR_OF_MEAN|0.033||0.0614|TWO_SIDED|95.0|-0.003|0.125|||Mixed Effects Model for Repeated Measure|||||0.125|-0.003|0.0614
72578091|NCT02006732|144683709|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.305|STANDARD_ERROR_OF_MEAN|0.033|<|0.0001|TWO_SIDED|95.0|0.24|0.37|||Mixed Effects Model for Repeated Measure|||||0.370|0.240|<0.0001
72578092|NCT02006732|144683709|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.114|STANDARD_ERROR_OF_MEAN|0.033||0.0005|TWO_SIDED|95.0|0.049|0.178|||Mixed Effects Model for Repeated Measure|||||0.178|0.049|0.0005
72578093|NCT02006732|144683709|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.191|STANDARD_ERROR_OF_MEAN|0.033|<|0.0001|TWO_SIDED|95.0|0.126|0.256|||Mixed Effects Model for Repeated Measure|||||0.256|0.126|<0.0001
72578094|NCT02006732|144683709|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.053|STANDARD_ERROR_OF_MEAN|0.033||0.1089|TWO_SIDED|95.0|-0.117|0.012|||Mixed Effects Model for Repeated Measure|||||0.012|-0.117|0.1089
72578095|NCT02006732|144683710|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.195|STANDARD_ERROR_OF_MEAN|0.27|<|0.0001|TWO_SIDED|95.0|0.665|1.725|||Mixed Effects Model for Repeated Measure|||||1.725|0.665|<0.0001
72578096|NCT02006732|144683710|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.582|STANDARD_ERROR_OF_MEAN|0.267||0.0296|TWO_SIDED|95.0|0.058|1.106|||Mixed Effects Model for Repeated Measure|||||1.106|0.058|0.0296
72578097|NCT02006732|144683710|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.263|STANDARD_ERROR_OF_MEAN|0.272|<|0.0001|TWO_SIDED|95.0|0.73|1.796|||Mixed Effects Model for Repeated Measure|||||1.796|0.730|<0.0001
72578098|NCT02006732|144683710|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.65|STANDARD_ERROR_OF_MEAN|0.269||0.0159|TWO_SIDED|95.0|0.122|1.178|||Mixed Effects Model for Repeated Measure|||||1.178|0.122|0.0159
72578099|NCT02006732|144683710|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.613|STANDARD_ERROR_OF_MEAN|0.273||0.0248|TWO_SIDED|95.0|0.078|1.148|||Mixed Effects Model for Repeated Measure|||||1.148|0.078|0.0248
72578100|NCT02006732|144683710|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.068|STANDARD_ERROR_OF_MEAN|0.266||0.7984|TWO_SIDED|95.0|-0.59|0.454|||Mixed Effects Model for Repeated Measure|||||0.454|-0.590|0.7984
72578101|NCT02006732|144683711|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.623|STANDARD_ERROR_OF_MEAN|0.193|<|0.0001|TWO_SIDED|95.0|1.245|2.0|||Mixed Effects Model for Repeated Measure|||||2.000|1.245|<0.0001
72578102|NCT02006732|144683711|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.594|STANDARD_ERROR_OF_MEAN|0.19||0.0019|TWO_SIDED|95.0|0.22|0.967|||Mixed Effects Model for Repeated Measure|||||0.967|0.220|0.0019
72578103|NCT02006732|144683711|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.611|STANDARD_ERROR_OF_MEAN|0.193|<|0.0001|TWO_SIDED|95.0|1.232|1.989|||Mixed Effects Model for Repeated Measure|||||1.989|1.232|<0.0001
72578104|NCT02006732|144683711|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.582|STANDARD_ERROR_OF_MEAN|0.191||0.0023|TWO_SIDED|95.0|0.207|0.956|||Mixed Effects Model for Repeated Measure|||||0.956|0.207|0.0023
72578105|NCT02006732|144683711|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.029|STANDARD_ERROR_OF_MEAN|0.194|<|0.0001|TWO_SIDED|95.0|0.649|1.41|||Mixed Effects Model for Repeated Measure|||||1.410|0.649|<0.0001
72578106|NCT02006732|144683711|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.012|STANDARD_ERROR_OF_MEAN|0.189||0.9494|TWO_SIDED|95.0|-0.359|0.383|||Mixed Effects Model for Repeated Measure|||||0.383|-0.359|0.9494
72578107|NCT02006732|144683712|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.432|STANDARD_ERROR_OF_MEAN|0.033|<|0.0001|TWO_SIDED|95.0|0.366|0.498|||Mixed Effects Model for Repeated Measure|||||0.498|0.366|<0.0001
72578108|NCT02006732|144683712|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.148|STANDARD_ERROR_OF_MEAN|0.033|<|0.0001|TWO_SIDED|95.0|0.084|0.212|||Mixed Effects Model for Repeated Measure|||||0.212|0.084|<0.0001
72411005|NCT01138124|144330484|SUPERIORITY_OR_OTHER||Unadjusted Odds Ratio|2.82|||<|0.0001|TWO_SIDED|95.0|1.86|4.28|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag)."|||4.28|1.86|<0.0001
72411006|NCT01138124|144330484|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|2.53|||<|0.0001|TWO_SIDED|95.0|1.66|3.85|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, chronic pancreatitis, neuropathic pain, epilepsy"|||3.85|1.66|<0.0001
72411007|NCT01138124|144330484|SUPERIORITY_OR_OTHER||Unadjusted Odds Ratio|2.75||||0.001|TWO_SIDED|95.0|1.51|5.03|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag)."|||5.03|1.51|0.001
72411008|NCT01138124|144330484|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|2.44||||0.0042|TWO_SIDED|95.0|1.32|4.49|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, chronic pancreatitis, neuropathic pain, epilepsy."|||4.49|1.32|0.0042
72543297|NCT01827371|144616933|NON_INFERIORITY_OR_EQUIVALENCE|Hypotheses Evaluation: The difference between the mean log2 peak titer for the control arm (Study Arm A) and each investigational arm (Study Arm B, C, or D) and the associated two sided 98.33% confidence intervals (CI) for the estimated population mean difference were calculated. If the upper limit of the 98.33% CI was less than 1, Study Arm B, C or D was considered to be non-inferior to Study Arm A.|Mean Difference (Log2 Scale)|1.32|||||TWO_SIDED|98.33|0.72|1.93||||||"Hypotheses: H0: log2(GMT(Arm A))-log2 (GMT(Arm B)) ≥ 1 or GMT(Arm A)/GMT (Arm B) ≥2 H1: log2(GMT(Arm A))-log2(GMT(Arm B)) \< 1 or GMT(Arm A)/GMT(Arm B) \< 2.~Sample Size: The SD for log2 PRNT based on a prior study was\~1.9. The margin of non-inferiority was specified as a 2-fold difference on the original scale (1 on the log2 scale). The objective included three non-inferiority evaluations (A vs. B, A vs. C, A vs. D). Thus, a Bonferroni-corrected alpha of 2.5% / 3 = 0.833% was used. Power=80%"||1.93|0.72|
72578109|NCT02006732|144683712|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.455|STANDARD_ERROR_OF_MEAN|0.034|<|0.0001|TWO_SIDED|95.0|0.387|0.522|||Mixed Effects Model for Repeated Measure|||||0.522|0.387|<0.0001
72578110|NCT02006732|144683712|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.171|STANDARD_ERROR_OF_MEAN|0.034|<|0.0001|TWO_SIDED|95.0|0.105|0.236|||Mixed Effects Model for Repeated Measure|||||0.236|0.105|<0.0001
72411009|NCT01138124|144330484|SUPERIORITY_OR_OTHER||Unadjusted Odds Ratio|1.8||||0.0645|TWO_SIDED|95.0|0.97|3.36|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag)."|||3.36|0.97|0.0645
72411010|NCT01138124|144330484|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.65||||0.1232|TWO_SIDED|95.0|0.87|3.11|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, chronic pancreatitis, neuropathic pain, epilepsy."|||3.11|0.87|0.1232
72411011|NCT01138124|144330484|SUPERIORITY_OR_OTHER||Unadjusted Odds Ratio|0.55||||0.316|TWO_SIDED|95.0|0.17|1.78|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag)."|||1.78|0.17|0.3160
72411012|NCT01138124|144330484|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|0.48||||0.2234|TWO_SIDED|95.0|0.15|1.57|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, chronic pancreatitis, neuropathic pain, epilepsy."|||1.57|0.15|0.2234
72578111|NCT02006732|144683712|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.284|STANDARD_ERROR_OF_MEAN|0.034|<|0.0001|TWO_SIDED|95.0|0.217|0.35|||Mixed Effects Model for Repeated Measure|||||0.350|0.217|<0.0001
72411013|NCT01138124|144330484|SUPERIORITY_OR_OTHER||Unadjusted Odds Ratio|1.35||||0.3071|TWO_SIDED|95.0|0.76|2.42|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag)."|||2.42|0.76|0.3071
72411014|NCT01138124|144330484|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.17||||0.6062|TWO_SIDED|95.0|0.65|2.11|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, chronic pancreatitis, neuropathic pain, epilepsy."|||2.11|0.65|0.6062
72411015|NCT01138124|144330484|SUPERIORITY_OR_OTHER||Unadjusted Odds Ratio|1.31||||0.5205|TWO_SIDED|95.0|0.58|2.97|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag)."|||2.97|0.58|0.5205
72411016|NCT01138124|144330484|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.11||||0.8042|TWO_SIDED|95.0|0.48|2.57|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, chronic pancreatitis, neuropathic pain, epilepsy."|||2.57|0.48|0.8042
72411017|NCT01138124|144330485|SUPERIORITY_OR_OTHER||Unadjusted Odds Ratio|3.15|||<|0.0001|TWO_SIDED|95.0|2.04|4.86|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag)."|||4.86|2.04|<0.0001
72578112|NCT02006732|144683712|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.022|STANDARD_ERROR_OF_MEAN|0.033||0.4974|TWO_SIDED|95.0|-0.087|0.042|||Mixed Effects Model for Repeated Measure|||||0.042|-0.087|0.4974
72578113|NCT01198132|144683745|SUPERIORITY_OR_OTHER||Rate ratio|0.8||||0.3797|TWO_SIDED|95.0|0.48|1.32|||Poisson log-linear model|||||1.32|0.48|0.3797
72578114|NCT03516513|144683755|SUPERIORITY|t-tests||||||0.905|||||||t-test, 2 sided|||||||0.905
72578115|NCT03516513|144683755|SUPERIORITY|t-test||||||0.32|||||||t-test, 2 sided|||||||.320
72411018|NCT01138124|144330485|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|2.88|||<|0.0001|TWO_SIDED|95.0|1.85|4.46|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, chronic pancreatitis, neuropathic pain, epilepsy."|||4.46|1.85|<0.0001
72578116|NCT03516513|144683756|SUPERIORITY|||||||0.155||||||Not adjusted for multiple comparisons|t-test, 2 sided|||||||.155
72578117|NCT03516513|144683756|SUPERIORITY|||||||0.974||||||Not adjusted for multiple comparisons|t-test, 2 sided|||||||.974
72578118|NCT03516513|144683758|SUPERIORITY|||||||0.212|||||||t-test, 2 sided|||||||.212
72578119|NCT03516513|144683759|SUPERIORITY|||||||0.507|||||||t-test, 2 sided|||||||.507
72578120|NCT03516513|144683760|SUPERIORITY|||||||0.091|||||||t-test, 2 sided|||||||.091
72578121|NCT00345631|144683771|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-15.68|||<|0.0001|TWO_SIDED|95.0|-19.04|-12.31||Multiplicity is addressed for the two co-primary effectiveness endpoints via a closed testing procedure where the time to hemostasis will be assessed first and then time to ambulation only if significance is first achieved for time to hemostasis.|t-test, 2 sided|||"Null hypothesis: The mean time to hemostasis for the manual compression (MC) arm is less or equal to that for the vascular closure device (VCD) arm.~The trial is powered to detect a 5 minute reduction in mean time to hemostasis and a 2 hour reduction in mean time to ambulation for VCD vs. MC with over 90% power and a 5% two-sided (2.5% one-sided) Type I error"||-12.31|-19.04|<0.0001
72578122|NCT00345631|144683772|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-3.7||||0.0028|TWO_SIDED|95.0|-5.53|-1.87||Multiplicity is addressed for the two co-primary effectiveness endpoints via a closed testing procedure where the time to hemostasis will be assessed first and then time to ambulation only if significance is first achieved for time to hemostasis.|t-test, 2 sided|||"Null hypothesis:The mean time to ambulation for the manual compression (MC) arm is less or equal to that for the vascular closure device (VCD) arm.~The trial is powered to detect a 5 minute reduction in mean time to hemostasis and a 2 hour reduction in mean time to ambulation for VCD vs. MC with over 90% power and a 5% two-sided (2.5% one-sided) Type I error"||-1.87|-5.53|0.0028
72578123|NCT00345631|144683773|NON_INFERIORITY_OR_EQUIVALENCE|The sample size is adequate to rule out a 4% or larger disadvantage for VCD vs. MC (null hypothesis: 2.5% MC vs. 6.5% VCD) in the incidence of major complications for VCD vs. MC using a 95% upper confidence bound for the VCD - MC difference with 80% power and a 5% one-sided Type I error|Mean Difference (Final Values)|0.0||||0.0006|ONE_SIDED|95.0||1.14||P-value was calculated using unconditional exact test of non-inferiority for difference of two binomial proportions (VCD vs. MC) with a margin of 4%.|unconditional exact test|||Based on pre-planned hypotheses, a minimum sample size of 390 randomized patients (260 VCD patients and 130 MC patients) would demonstrate non-inferiority for the primary safety endpoint and superiority for both co-primary effectiveness endpoints in comparing VCD vs. MC.||1.14||0.0006
72578124|NCT00345631|144683774|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.7||||0.154|TWO_SIDED|95.0|-7.84|0.45|||t-test, 2 sided|||Null hypothesis: The mean time to eligibility for hospital discharge for the manual compression (MC) arm is equal to that for the vascular closure device (VCD) arm.||0.45|-7.84|0.1540
72578125|NCT00345631|144683775|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.57||||0.3612|TWO_SIDED|95.0|-7.46|2.31|||t-test, 2 sided|||Null hypothesis: The mean time to hospital discharge for the manual compression (MC) arm is equal to that for the vascular closure device (VCD) arm.||2.31|-7.46|0.3612
72578126|NCT00345631|144683778|SUPERIORITY_OR_OTHER||Proportion difference|0.7||||0.85|TWO_SIDED|95.0|-4.8|7.4|||t-test, 2 sided|||Null hypothesis: The percentages of patients achieving procedure success between the vascular closure device and manual compression arms are equal.||7.4|-4.8|0.85
72543298|NCT01827371|144616933|NON_INFERIORITY_OR_EQUIVALENCE|Hypotheses Evaluation: The difference between the mean log2 peak titer for the control arm (Study Arm A) and each investigational arm (Study Arm B, C, or D) and the associated two sided 98.33% confidence intervals (CI) for the estimated population mean difference were calculated. If the upper limit of the 98.33% CI was less than 1, Study Arm B, C or D was considered to be non-inferior to Study Arm A.|Mean Difference (Log2 Scale)|0.86|||||TWO_SIDED|98.33|0.26|1.47||||||"Hypotheses: H0: log2(GMT(Arm A))-log2 (GMT(Arm C)) ≥ 1 or GMT(Arm A)/GMT (Arm C) ≥2 H1: log2(GMT(Arm A))-log2(GMT(Arm C)) \< 1 or GMT(Arm A)/GMT(Arm C) \< 2.~Sample Size: The SD for log2 PRNT based on a prior study was\~1.9. The margin of non-inferiority was specified as a 2-fold difference on the original scale (1 on the log2 scale). The objective included three non-inferiority evaluations (A vs. B, A vs. C, A vs. D). Thus, a Bonferroni-corrected alpha of 2.5% / 3 = 0.833% was used. Power=80%"||1.47|0.26|
72543299|NCT01827371|144616933|NON_INFERIORITY_OR_EQUIVALENCE|Hypotheses Evaluation: The difference between the mean log2 peak titer for the control arm (Study Arm A) and each investigational arm (Study Arm B, C, or D) and the associated two sided 98.33% confidence intervals (CI) for the estimated population mean difference were calculated. If the upper limit of the 98.33% CI was less than 1, Study Arm B, C or D was considered to be non-inferior to Study Arm A.|Mean Difference (Log2 Scale)|0.41|||||TWO_SIDED|98.33|-0.17|1.0007||||||"Hypotheses: H0: log2(GMT(Arm A))-log2 (GMT(Arm D)) ≥ 1 or GMT(Arm A)/GMT (Arm D) ≥2 H1: log2(GMT(Arm A))-log2(GMT(Arm D)) \< 1 or GMT(Arm A)/GMT(Arm D) \< 2.~Sample Size: The SD for log2 PRNT based on a prior study was\~1.9. The margin of non-inferiority was specified as a 2-fold difference on the original scale (1 on the log2 scale). The objective included three non-inferiority evaluations (A vs. B, A vs. C, A vs. D). Thus, a Bonferroni-corrected alpha of 2.5% / 3 = 0.833% was used. Power=80%"||1.0007|-0.17|
72543300|NCT01827371|144616934|SUPERIORITY_OR_OTHER|||||||0.4782|TWO_SIDED|||||alpha= 5%|Fisher Exact|||"Hypothesis:~H0: Pr('Pain at Injection Site ' Arm A) = Pr('Pain at Injection Site ' Arm D) H1: Pr('Pain at Injection Site ' Arm A) not = Pr('Pain at Injection Site ' Arm D)"||||0.4782
72543301|NCT01827371|144616934|SUPERIORITY_OR_OTHER|||||||0.1704|TWO_SIDED|||||alpha= 5%|Fisher Exact|||"Hypothesis:~H0: Pr('Itchiness at Injection Site' Arm A) = Pr('Itchiness at Injection Site' Arm D) H1: Pr('Itchiness at Injection Site' Arm A) not = Pr('Itchiness at Injection Site' Arm D)"||||0.1704
72543302|NCT01827371|144616934|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED|||||alpha= 5%|Fisher Exact|||"Hypothesis:~H0: Pr('Underarm pain' Arm A) = Pr('Underarm pain' Arm D) H1: Pr('Underarm pain' Arm A) not = Pr('Underarm pain' Arm D)"||||1.000
72543303|NCT01827371|144616934|SUPERIORITY_OR_OTHER|||||||0.6171|TWO_SIDED|||||alpha= 5%|Fisher Exact|||"Hypothesis:~H0: Pr('Underarm swelling' Arm A) = Pr('Underarm swelling' Arm D) H1: Pr('Underarm swelling' Arm A) not = Pr('Underarm swelling' Arm D)"||||0.6171
72543304|NCT01827371|144616934|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||alpha=5%|Fisher Exact|||"Hypothesis:~H0: Pr('Redness at Injection Site' Arm A) = Pr('Redness at Injection Site' Arm D) H1: Pr('Redness at Injection Site' Arm A) not = Pr('Redness at Injection Site' Arm D)"||||<0.0001
72543305|NCT01827371|144616934|SUPERIORITY_OR_OTHER|||||||0.005|TWO_SIDED|||||alpha=5%|Fisher Exact|||"Hypothesis:~H0: Pr('Swelling at Injection Site' Arm A) = Pr('Swelling at Injection Site' Arm D) H1: Pr('Swelling at Injection Site' Arm A) not = Pr('Swelling at Injection Site' Arm D)"||||0.0050
72543306|NCT01827371|144616934|SUPERIORITY_OR_OTHER|||||||0.0012|TWO_SIDED|||||alpha=5%|Fisher Exact|||"Hypothesis:~H0: Pr('Any Solicited Local Reaction' Arm A) = Pr('Any Solicited Local Reaction' Arm D) H1: Pr('Any Solicited Local Reaction' Arm A) not = Pr('Any Solicited Local Reaction' Arm D)"||||0.0012
72543307|NCT01827371|144616935|NON_INFERIORITY_OR_EQUIVALENCE|Hypotheses Evaluation: The difference between the mean log2 peak titer for the control arm (Study Arm A) and each investigational arm (Study Arm B, C, or D) and the associated two sided 98.33% confidence intervals (CI) for the estimated population mean difference were calculated. If the upper limit of the 98.33% CI was less than 1, Study Arm B, C or D was considered to be non-inferior to Study Arm A.|Mean Difference (Log2 Scale)|0.76|||||TWO_SIDED|98.33|0.37|1.15||||||"Hypotheses: H0: log2(GMT(Arm A))-log2 (GMT(Arm B)) ≥ 1 or GMT(Arm A)/GMT (Arm B) ≥2 H1: log2(GMT(Arm A))-log2(GMT(Arm B)) \< 1 or GMT(Arm A)/GMT(Arm B) \< 2.~The margin of non-inferiority was specified as a 2-fold difference on the original scale (1 on the log2 scale). The objective included three non-inferiority evaluations (A vs. B, A vs. C, A vs. D). Thus, a Bonferroni-corrected alpha of 2.5% / 3 = 0.833% was used."||1.15|0.37|
72543308|NCT01827371|144616935|NON_INFERIORITY_OR_EQUIVALENCE|Hypotheses Evaluation: The difference between the mean log2 peak titer for the control arm (Study Arm A) and each investigational arm (Study Arm B, C, or D) and the associated two sided 98.33% confidence intervals (CI) for the estimated population mean difference were calculated. If the upper limit of the 98.33% CI was less than 1, Study Arm B, C or D was considered to be non-inferior to Study Arm A.|Mean Difference (Log2 Scale)|0.3|||||TWO_SIDED|98.33|-0.06|0.67||||||"Hypotheses: H0: log2(GMT(Arm A))-log2 (GMT(Arm C)) ≥ 1 or GMT(Arm A)/GMT (Arm C) ≥2 H1: log2(GMT(Arm A))-log2(GMT(Arm C)) \< 1 or GMT(Arm A)/GMT(Arm C) \< 2.~The margin of non-inferiority was specified as a 2-fold difference on the original scale (1 on the log2 scale). The objective included three non-inferiority evaluations (A vs. B, A vs. C, A vs. D). Thus, a Bonferroni-corrected alpha of 2.5% / 3 = 0.833% was used."||0.67|-0.06|
72543309|NCT01827371|144616935|NON_INFERIORITY_OR_EQUIVALENCE|Hypotheses Evaluation: The difference between the mean log2 peak titer for the control arm (Study Arm A) and each investigational arm (Study Arm B, C, or D) and the associated two sided 98.33% confidence intervals (CI) for the estimated population mean difference were calculated. If the upper limit of the 98.33% CI was less than 1, Study Arm B, C or D was considered to be non-inferior to Study Arm A.|Mean Difference (Log2 Scale)|-0.1|||||TWO_SIDED|98.33|-0.5|0.3||||||"Hypotheses: H0: log2(GMT(Arm A))-log2 (GMT(Arm D)) ≥ 1 or GMT(Arm A)/GMT (Arm D) ≥2 H1: log2(GMT(Arm A))-log2(GMT(Arm D)) \< 1 or GMT(Arm A)/GMT(Arm D) \< 2.~The margin of non-inferiority was specified as a 2-fold difference on the original scale (1 on the log2 scale). The objective included three non-inferiority evaluations (A vs. B, A vs. C, A vs. D). Thus, a Bonferroni-corrected alpha of 2.5% / 3 = 0.833% was used."||0.30|-0.50|
72543310|NCT01361607|144616939|SUPERIORITY||Median Difference (Final Values)|-1.84||||0.2735|TWO_SIDED|95.0|-6.19|1.5|||Wilcoxon (Mann-Whitney)|||||1.50|-6.19|0.2735
72543311|NCT01809314|144616950|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon signed-rank test|||The difference between Baseline and Month 4 was analyzed using the Wilcoxon signed-rank test.||||<0.0001
72543312|NCT01809314|144616951|SUPERIORITY_OR_OTHER|||||||0.001|||||||Wilcoxon signed-rank test|||Overall (all categories combined) change from Baseline in ECOG performance status at Month 4 was analyzed using Wilcoxon signed-rank test.||||0.001
72543313|NCT00219557|144616958|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.758||||0.1026|TWO_SIDED|95.0|0.49|1.17||One-sided log-rank test at alpha = 0.1 significance level was used.|Log Rank|||Differences in OS between treatment arms was analyzed by the stratified log-rank test where the stratification factors are Eastern Cooperative Oncology Group (ECOG) performance status (less than or equal to 1 or 2) and extent of disease (locally advanced or metastatic).||1.170|0.490|0.1026
72543314|NCT00219557|144616969|SUPERIORITY_OR_OTHER||Difference in response rate|4.3||||0.661|TWO_SIDED|95.0|-4.0|12.7|||Fisher Exact|||Difference in percent of participants with overall response expressed as response rate, was used for calculation of 95% confidence interval (CI).||12.7|-4.0|0.661
72543315|NCT00219557|144616971|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.9648||||0.4466|TWO_SIDED|95.0|0.54|1.73||One-sided log-rank test at alpha = 0.1 significance level was used.|Log Rank|||Differences in PFS between treatment arms was analyzed by the stratified log-rank test where the stratification factors are ECOG performance status (less than equal to 1 or 2) and extent of disease (locally advanced or metastatic).||1.7300|0.5400|0.4466
72543316|NCT00219557|144616973|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.44|||||TWO_SIDED|95.0|-19.06|2.19||||||For change in global QoL at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.||2.19|-19.06|
72543317|NCT00219557|144616973|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.02|||||TWO_SIDED|95.0|-15.4|3.36||||||For change in physical functioning at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.||3.36|-15.4|
72543318|NCT00219557|144616973|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.32|||||TWO_SIDED|95.0|-23.77|5.12||||||For change in role functioning at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.||5.12|-23.77|
72543319|NCT00219557|144616973|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.73|||||TWO_SIDED|95.0|-15.25|5.79||||||For change in emotional functioning at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.||5.79|-15.25|
72543320|NCT00219557|144616973|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.11|||||TWO_SIDED|95.0|-15.83|5.61||||||For change in cognitive functioning at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.||5.61|-15.83|
72543321|NCT00219557|144616973|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.33|||||TWO_SIDED|95.0|-18.72|12.06||||||For change in social functioning at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.||12.06|-18.72|
72543322|NCT00219557|144616973|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.41|||||TWO_SIDED|95.0|-1.62|22.44||||||For change in fatigue at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.||22.44|-1.62|
72543323|NCT00219557|144616973|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.3|||||TWO_SIDED|95.0|-16.55|7.96||||||For change in nausea and vomiting at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.||7.96|-16.55|
72543324|NCT00219557|144616973|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.37|||||TWO_SIDED|95.0|-7.57|22.32||||||For change in pain at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.||22.32|-7.57|
72543325|NCT00219557|144616973|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.51|||||TWO_SIDED|95.0|-1.28|26.3||||||For change in dyspnea at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.||26.30|-1.28|
72543326|NCT00219557|144616973|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.9|||||TWO_SIDED|95.0|-5.7|25.49||||||For change in insomnia at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.||25.49|-5.70|
72543327|NCT00219557|144616973|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.63|||||TWO_SIDED|95.0|-4.81|32.07||||||For change in appetite loss at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.||32.07|-4.81|
72543328|NCT00219557|144616973|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.67|||||TWO_SIDED|95.0|-11.62|20.96||||||For change in constipation at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.||20.96|-11.62|
72411019|NCT01138124|144330485|SUPERIORITY_OR_OTHER||Unadjusted Odds Ratio|2.75||||0.0015|TWO_SIDED|95.0|1.47|5.13|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag)."|||5.13|1.47|0.0015
72411020|NCT01138124|144330485|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|2.45||||0.0053|TWO_SIDED|95.0|1.31|4.62|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, chronic pancreatitis, neuropathic pain, epilepsy."|||4.62|1.31|0.0053
72411021|NCT01138124|144330485|SUPERIORITY_OR_OTHER||Unadjusted Odds Ratio|1.68||||0.0777|TWO_SIDED|95.0|0.94|2.99|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag)."|||2.99|0.94|0.0777
72543329|NCT00219557|144616973|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.28|||||TWO_SIDED|95.0|-15.1|12.54||||||For change in diarrhea at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.||12.54|-15.1|
72543330|NCT00219557|144616973|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.43|||||TWO_SIDED|95.0|-4.67|15.53||||||For change in financial difficulties at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.||15.53|-4.67|
72543331|NCT00219557|144616973|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.83|||||TWO_SIDED|95.0|-32.34|0.67||||||For change in global QoL at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.||0.67|-32.34|
72543332|NCT00219557|144616973|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.58|||||TWO_SIDED|95.0|-24.12|0.96||||||For change in physical functioning at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.||0.96|-24.12|
72578127|NCT03390426|144683794|SUPERIORITY|"this is a superiority study and the non-inferiority or equivalence analysis is not required"|||||<|0.05||||||Comparisons were made between the two groups using a two-sample t-test or Mann-Whitney U test for continuous variables and Fisher's exact test for categorical variables. p-value of \<0.05 was considered to be statistically significant.|t-test, 2 sided|Comparisons were made using a two-sample t-test or Mann-Whitney U test for continuous variables and Fisher's exact test for categorical variables.||We determined 30 subjects were needed to detect a 50% difference in THN incidence between the two groups using a one-sided Fisher's exact test with alpha = 0.05 and 80% power while allowing up to 20% drop-out. For primary and secondary outcomes, comparisons were made between the two groups using a two-sample t-test or Mann-Whitney U test for continuous variables and Fisher's exact test for categorical variables. p-value of \<0.05 was considered to be statistically significant.||||<0.05
72578128|NCT02924727|144683816|SUPERIORITY||Hazard Ratio (HR)|0.9012||||0.1659|TWO_SIDED|95.0|0.7778|1.0441|||Cox's Proportional Hazard Model|||Primary Composite||1.0441|0.7778|0.1659
72578129|NCT02924727|144683816|SUPERIORITY||Hazard Ratio (HR)|0.874||||0.2031|TWO_SIDED|95.0|0.7104|1.0754|||Cox's Proportional Hazard Model|||CV Death||1.0754|0.7104|0.2031
72578130|NCT02924727|144683816|SUPERIORITY||Hazard Ratio (HR)|0.8653||||0.1679|TWO_SIDED|95.0|0.7044|1.0629|||Cox's Proportional Hazard Model|||First HF Hospitalization||1.0629|0.7044|0.1679
72578131|NCT02924727|144683816|SUPERIORITY||Hazard Ratio (HR)|0.6831||||0.0667|TWO_SIDED|95.0|0.4546|1.0266|||Cox's Proportional Hazard Model|||First Outpatient HF||1.0266|0.4546|0.0667
72578132|NCT02924727|144683817|SUPERIORITY||Hazard Ratio (HR)|0.9133||||0.2507|TWO_SIDED|95.0|0.7824|1.0662|||Cox's Proportional Hazard Model|||CV death or HF hospitalization||1.0662|0.7824|0.2507
72578133|NCT02924727|144683818|SUPERIORITY||Hazard Ratio (HR)|0.8422||||0.0732|TWO_SIDED|95.0|0.6979|1.0163|||Cox's Proportional Hazard Model|||HF hospitalization or Outpatient HF||1.0163|0.6979|0.0732
72578134|NCT02924727|144683819|SUPERIORITY||Hazard Ratio (HR)|0.9007||||0.1785|TWO_SIDED|95.0|0.7734|1.0489|||Cox's Proportional Hazard Model|||CV death, Non-fatal spontaneous MI or Non-fatal stroke||1.0489|0.7734|0.1785
72578135|NCT02924727|144683820|SUPERIORITY||Rate Ratio|0.8361||||0.0452|TWO_SIDED|95.0|0.7018|0.9961|||Negative Binomial regression model|||Total Number of Confirmed Composite Endpoints||0.9961|0.7018|0.0452
72578136|NCT02924727|144683821|SUPERIORITY||Hazard Ratio (HR)|0.8751||||0.1556|TWO_SIDED|95.0|0.7279|1.052|||Cox's Proportional Hazard Model|||All-Cause Death||1.0520|0.7279|0.1556
72578137|NCT00509795|144683826|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin was set at 10%. The power is 90% according to the sample size estimation of the study protocol. Although not in the analysis plan for the study, in a separate communication, the FDA further explained that, whereas the 10% non-inferiority margin would be used to assess non-inferiority, a 5% non-inferiority margin would be used to assess clinical equivalence.|Risk Difference (RD)|-0.7|||||TWO_SIDED|95.1|-4.4|3.1|||||The difference is calculated as ranibizumab minus IAI. A positive value favors IAI 2.0Q4. As adjustment of multiple comparisons as conditional sequence of statistical hypotheses is used with alpha = 0.049.|The statistical approach included a conditional sequence of calculations of the 95.1% CI using normal approximation of the difference between the proportion of patients with maintained vision at Week 52 for the group treated with 0.5 mg ranibizumab and the proportion of patients with maintained vision for each of the groups treated with IAI.||3.1|-4.4|
72411022|NCT01138124|144330485|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.5||||0.1762|TWO_SIDED|95.0|0.83|2.69|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, chronic pancreatitis, neuropathic pain, epilepsy."|||2.69|0.83|0.1762
72411023|NCT01138124|144330485|SUPERIORITY_OR_OTHER||Unadjusted Odds Ratio|0.82||||0.699|TWO_SIDED|95.0|0.29|2.28|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag)."|||2.28|0.29|0.6990
72411024|NCT01138124|144330485|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|0.72||||0.5274|TWO_SIDED|95.0|0.26|2.01|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, chronic pancreatitis, neuropathic pain, epilepsy."|||2.01|0.26|0.5274
72411025|NCT01138124|144330485|SUPERIORITY_OR_OTHER||Unadjusted Odds Ratio|1.34||||0.3245|TWO_SIDED|95.0|0.75|2.39|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag)."|||2.39|0.75|0.3245
72411026|NCT01138124|144330485|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.15||||0.6388|TWO_SIDED|95.0|0.64|2.07|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, chronic pancreatitis, neuropathic pain, epilepsy."|||2.07|0.64|0.6388
72411027|NCT01138124|144330485|SUPERIORITY_OR_OTHER||Unadjusted Odds Ratio|1.11||||0.796|TWO_SIDED|95.0|0.49|2.51|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag)."|||2.51|0.49|0.796
72411028|NCT01138124|144330485|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|0.94||||0.8772|TWO_SIDED|95.0|0.41|2.15|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, chronic pancreatitis, neuropathic pain, epilepsy."|||2.15|0.41|0.8772
72411029|NCT01138124|144330486|SUPERIORITY_OR_OTHER||Unadjusted Odds Ratio|2.9|||<|0.0001|TWO_SIDED|95.0|1.88|4.47|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag)."|||4.47|1.88|<0.0001
72411030|NCT01138124|144330486|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|2.65|||<|0.0001|TWO_SIDED|95.0|1.71|4.11|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, chronic pancreatitis, neuropathic pain, epilepsy."|||4.11|1.71|<0.0001
72411031|NCT01138124|144330486|SUPERIORITY_OR_OTHER||Unadjusted Odds Ratio|2.19||||0.0212|TWO_SIDED|95.0|1.12|4.25|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag)."|||4.25|1.12|0.0212
72411032|NCT01138124|144330486|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.95||||0.0522|TWO_SIDED|95.0|0.99|3.81|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, chronic pancreatitis, neuropathic pain, epilepsy."|||3.81|0.99|0.0522
72411033|NCT01138124|144330486|SUPERIORITY_OR_OTHER||Unadjusted Odds Ratio|1.87||||0.0337|TWO_SIDED|95.0|1.05|3.32|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag)."|||3.32|1.05|0.0337
72411034|NCT01138124|144330486|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.64||||0.0947|TWO_SIDED|95.0|0.92|2.95|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, chronic pancreatitis, neuropathic pain, epilepsy."|||2.95|0.92|0.0947
72578138|NCT00509795|144683826|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin was set at 10%. The power is 90% according to the sample size estimation of the study protocol. Although not in the analysis plan for the study, in a separate communication, the FDA further explained that, whereas the 10% non-inferiority margin would be used to assess non-inferiority, a 5% non-inferiority margin would be used to assess clinical equivalence.|Risk Difference (RD)|-1.5|||||TWO_SIDED|95.1|-5.1|2.1|||||The difference is calculated as ranibizumab minus IAI. A negative value favors the IAI 0.5Q4 group. As adjustment of multiple comparisons as conditional sequence of statistical hypotheses is used with alpha = 0.049.|The statistical approach included a conditional sequence of calculations of the 95.1% CI using normal approximation of the difference between the proportion of patients with maintained vision at Week 52 for the group treated with 0.5 mg ranibizumab and the proportion of patients with maintained vision for each of the groups treated with IAI (EYLEA, VEGF Trap-Eye).||2.1|-5.1|
72578139|NCT00509795|144683826|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin was set at 10%. The power is 90% according to the sample size estimation of the study protocol. Although not in the analysis plan for the study, in a separate communication, the FDA further explained that, whereas the 10% non-inferiority margin would be used to assess non-inferiority, a 5% non-inferiority margin would be used to assess clinical equivalence.|Risk Difference (RD)|-0.7|||||TWO_SIDED|95.1|-4.5|3.1|||||The difference is calculated as ranibizumab minus IAI. A negative value favors the IAI 2.0Q8 group. As adjustment of multiple comparisons as conditional sequence of statistical hypotheses is used with alpha = 0.049.|The statistical approach included a conditional sequence of calculations of the 95.1% CI using normal approximation of the difference between the proportion of patients with maintained vision at Week 52 for the group treated with 0.5 mg ranibizumab and the proportion of patients with maintained vision for each of the groups treated with IAI (EYLEA, VEGF Trap-Eye).||3.1|-4.5|
72578140|NCT00509795|144683827|SUPERIORITY_OR_OTHER||Differences in Least Squares means|3.15||||0.0054|TWO_SIDED|95.1|0.92|5.37||As adjustment of multiple comparisons, a conditional sequence of statistical hypotheses is used with alpha = 0.049|ANCOVA||The difference is calculated as IAI minus ranibizumab. A positive value favors IAI 2.0Q4.|The pairwise comparison is performed as contrast statement in the analysis of covariance model with treatment group as fixed factor (all 4 treatment groups) and the baseline measure as covariate. The null hypothesis is that both mean changes are equal.||5.37|0.92|0.0054
72578141|NCT00509795|144683827|SUPERIORITY_OR_OTHER||Differences in Least Squares means|0.8||||0.4793|TWO_SIDED|95.1|-3.03|1.43||As adjustment of multiple comparisons, a conditional sequence of statistical hypotheses is used with alpha = 0.049|ANCOVA||The difference is calculated as IAI minus ranibizumab. A positive value favors IAI 0.5Q4.|The pairwise comparison is performed as contrast statement in the analysis of covariance model with treatment group as fixed factor (all 4 treatment groups) and the baseline measure as covariate. The null hypothesis is that both mean changes are equal.||1.43|-3.03|0.4793
72578142|NCT00509795|144683827|SUPERIORITY_OR_OTHER||Differences in Least Squares Means|0.26||||0.8179|TWO_SIDED|95.1|-1.97|2.49||As adjustment of multiple comparisons, a conditional sequence of statistical hypotheses is used with alpha = 0.049|ANCOVA||The difference is calculated as IAI minus ranibizumab. A positive value favors IAI 2.0Q8.|The pairwise comparison is performed as contrast statement in the analysis of covariance model with treatment group as fixed factor (all 4 treatment groups) and the baseline measure as covariate. The null hypothesis is that both mean changes are equal.||2.49|-1.97|0.8179
72578143|NCT00509795|144683828|SUPERIORITY_OR_OTHER||Risk Difference (RD)|6.6||||0.1042|TWO_SIDED|95.1|-1.0|14.1||As adjustment of multiple comparisons, a conditional sequence of statistical hypotheses is used with alpha = 0.049.|Chi-squared||The difference is calculated as IAI minus ranibizumab. A positive value favors IAI 2.0Q4.|The null hypothesis is that both percentages are equal.||14.1|-1.0|0.1042
72578144|NCT00509795|144683828|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-6.0||||0.1037|TWO_SIDED|95.1|-13.2|1.2||As adjustment of multiple comparisons, a conditional sequence of statistical hypotheses is used with alpha = 0.049.|Chi-squared||The difference is calculated as IAI minus ranibizumab. A positive value favors IAI 0.5Q4.|The null hypothesis is that both percentages are equal.||1.2|-13.2|0.1037
72578145|NCT00509795|144683828|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.4||||0.93|TWO_SIDED|95.1|-7.7|7.0||As adjustment of multiple comparisons, a conditional sequence of statistical hypotheses is used with alpha = 0.049.|Chi-squared||The difference is calculated as VEGF Trap-Eye minus ranibizumab. A positive value favors VEGF Trap-Eye 2.0Q8.|The pairwise The null hypothesis is that both percentages are equal.||7.0|-7.7|0.93
72578146|NCT00509795|144683829|SUPERIORITY_OR_OTHER||Differences Least Squares means|1.28||||0.209|TWO_SIDED|95.1|-0.73|3.28||As adjustment of multiple comparisons, a conditional sequence of statistical hypotheses is used with alpha = 0.049|ANCOVA||The difference is calculated as IAI minus ranibizumab. A positive value favors IAI 2.0Q4.|The pairwise comparison is performed as contrast statement in the analysis of covariance model with treatment group as fixed factor (all 4 treatment groups) and the baseline measure as covariate. The null hypothesis is that both mean changes are equal.||3.28|-0.73|0.2090
72578147|NCT00509795|144683829|SUPERIORITY_OR_OTHER||Differences in Least Squares means|-0.67||||0.5128|TWO_SIDED|95.1|-2.69|1.35||As adjustment of multiple comparisons, a conditional sequence of statistical hypotheses is used with alpha = 0.049|ANCOVA||The difference is calculated as IAI minus ranibizumab. A positive value favors IAI 0.5Q4.|The pairwise comparison is performed as contrast statement in the analysis of covariance model with treatment group as fixed factor (all 4 treatment groups) and the baseline measure as covariate. The null hypothesis is that both mean changes are equal.||1.35|-2.69|0.5128
72329457|NCT03037476|144184382|OTHER|General Linear Model|Slope|0.999||||0.397|TWO_SIDED|95.0|-1.312|3.31|||Mixed Models Analysis|Negative Binomial Regression||Change in Past 3 Month Heroin Use from Baseline to 12 Month Followup||3.310|-1.312|.397
72411035|NCT01138124|144330486|SUPERIORITY_OR_OTHER||Unadjusted Odds Ratio|1.42||||0.3928|TWO_SIDED|95.0|0.64|3.16|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag)."|||3.16|0.64|0.3928
72411036|NCT01138124|144330486|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.21||||0.6502|TWO_SIDED|95.0|0.54|2.72|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, chronic pancreatitis, neuropathic pain, epilepsy."|||2.72|0.54|0.6502
72411037|NCT01138124|144330486|SUPERIORITY_OR_OTHER||Unadjusted Odds Ratio|1.34||||0.3275|TWO_SIDED|95.0|0.75|2.39|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag)."|||2.39|0.75|0.3275
72411038|NCT01138124|144330486|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.15||||0.6365|TWO_SIDED|95.0|0.64|2.08|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, chronic pancreatitis, neuropathic pain, epilepsy."|||2.08|0.64|0.6365
72411039|NCT01138124|144330486|SUPERIORITY_OR_OTHER||Unadjusted Odds Ratio|1.01||||0.9858|TWO_SIDED|95.0|0.42|2.41|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag)."|||2.41|0.42|0.9858
72411040|NCT01138124|144330486|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|0.87||||0.7671|TWO_SIDED|95.0|0.36|2.12|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, chronic pancreatitis, neuropathic pain, epilepsy."|||2.12|0.36|0.7671
72411041|NCT01138124|144330487|SUPERIORITY_OR_OTHER||Unadjusted Odds Ratio|1.79||||0.0031|TWO_SIDED|95.0|1.22|2.63|||Conditional Logistic Regression||"Comparison: Ever (without 2 year lag) and Never (without 2 year lag)."|||2.63|1.22|0.0031
72543333|NCT00219557|144616973|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-18.65|||||TWO_SIDED|95.0|-35.47|-1.83||||||For change in role functioning at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.||-1.83|-35.47|
72329458|NCT03037476|144184382|OTHER|General Linear Model|Slope|0.465||||0.303|TWO_SIDED|95.0|-0.419|1.349|||Mixed Models Analysis|Negative Binomial Regression||Change in Past 3 Month Nonmedical Prescription Drug Use from Baseline to 6 Month Followup||1.349|-.419|.303
72411042|NCT01138124|144330487|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.68||||0.0095|TWO_SIDED|95.0|1.13|2.49|||Conditional Logistic Regression||"Comparison: Ever (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, hypertension, diuretic use, diabetes, neuropathic pain, and epilepsy."|||2.49|1.13|0.0095
72411043|NCT01138124|144330487|SUPERIORITY_OR_OTHER||Unadjusted Odds Ratio|1.65||||0.097|TWO_SIDED|95.0|0.91|2.99|||Conditional Logistic Regression||"Comparison: Ever (with 2 year lag) and Never (with 2 year lag)."|||2.99|0.91|0.0970
72411044|NCT01138124|144330487|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.63||||0.1123|TWO_SIDED|95.0|0.89|2.97|||Conditional Logistic Regression||"Comparison: Ever (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, hypertension, diuretic use, diabetes, neuropathic pain, and epilepsy."|||2.97|0.89|0.1123
72411045|NCT01138124|144330488|SUPERIORITY_OR_OTHER||Unadjusted Odds Ratio|2.53||||0.0012|TWO_SIDED|95.0|1.44|4.44|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag)"|||4.44|1.44|0.0012
72411046|NCT01138124|144330488|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|2.34||||0.0034|TWO_SIDED|95.0|1.32|4.14|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, hypertension, diuretic use, diabetes, neuropathic pain, and epilepsy."|||4.14|1.32|0.0034
72411047|NCT01138124|144330488|SUPERIORITY_OR_OTHER||Unadjusted Odds Ratio|2.18||||0.0856|TWO_SIDED|95.0|0.9|5.32|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, hypertension, diuretic use, diabetes, neuropathic pain, and epilepsy."|||5.32|0.9|0.0856
72411048|NCT01138124|144330488|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|2.14||||0.0996|TWO_SIDED|95.0|0.87|5.28|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, hypertension, diuretic use, diabetes, neuropathic pain, and epilepsy."|||5.28|0.87|0.0996
72411049|NCT01138124|144330488|SUPERIORITY_OR_OTHER||Unadjusted Odds Ratio|1.89||||0.0563|TWO_SIDED|95.0|0.98|3.63|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag)."|||3.63|0.98|0.0563
72411050|NCT01138124|144330488|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.77||||0.0896|TWO_SIDED|95.0|0.92|3.43|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, hypertension, diuretic use, diabetes, neuropathic pain, and epilepsy."|||3.43|0.92|0.0896
72411051|NCT01138124|144330488|SUPERIORITY_OR_OTHER||Unadjusted Odds Ratio|1.4||||0.5308|TWO_SIDED|95.0|0.49|4.01|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag)."|||4.01|0.49|0.5308
72411052|NCT01138124|144330488|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.39||||0.5458|TWO_SIDED|95.0|0.48|4.02|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, hypertension, diuretic use, diabetes, neuropathic pain, and epilepsy."|||4.02|0.48|0.5458
72411053|NCT01138124|144330488|SUPERIORITY_OR_OTHER||Unadjusted Odds Ratio|0.87||||0.7744|TWO_SIDED|95.0|0.35|2.19|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag)."|||2.19|0.35|0.7744
72411054|NCT01138124|144330488|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|0.83||||0.6999|TWO_SIDED|95.0|0.33|2.11|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, hypertension, diuretic use, diabetes, neuropathic pain, and epilepsy."|||2.11|0.33|0.6999
72543334|NCT00219557|144616973|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.92|||||TWO_SIDED|95.0|-29.16|1.32||||||For change in emotional functioning at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.||1.32|-29.16|
72543335|NCT00219557|144616973|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.1|||||TWO_SIDED|95.0|-20.97|6.77||||||For change in cognitive functioning at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.||6.77|-20.97|
72543336|NCT00219557|144616973|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.62|||||TWO_SIDED|95.0|-28.28|9.04||||||For change in social functioning at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.||9.04|-28.28|
72543337|NCT00219557|144616973|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.14|||||TWO_SIDED|95.0|-1.27|33.54||||||For change in fatigue at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.||33.54|-1.27|
72543338|NCT00219557|144616973|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.8|||||TWO_SIDED|95.0|-18.78|15.18||||||For change in nausea and vomiting at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.||15.18|-18.78|
72543339|NCT00219557|144616973|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.59|||||TWO_SIDED|95.0|-3.22|36.39||||||For change in pain at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.||36.39|-3.22|
72329459|NCT03037476|144184382|OTHER|General Linear Model|Slope|0.939|||<|0.05|TWO_SIDED|95.0|0.128|1.751|||Mixed Models Analysis|Negative Binomial Regression||Change in Past 3 Month Nonmedical Prescription Drug Use from Baseline to 12 Month Followup||1.751|.128|<.05
72543340|NCT00219557|144616973|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.39|||||TWO_SIDED|95.0|-5.68|26.47||||||For change in dyspnea at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.||26.47|-5.68|
72543341|NCT00219557|144616973|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.59|||||TWO_SIDED|95.0|-20.19|23.36||||||For change in insomnia at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.||23.36|-20.19|
72411055|NCT01138124|144330488|SUPERIORITY_OR_OTHER||Unadjusted Odds Ratio|1.32||||0.6528|TWO_SIDED|95.0|0.39|4.47|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag)."|||4.47|0.39|0.6528
72411056|NCT01138124|144330488|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.3||||0.6722|TWO_SIDED|95.0|0.38|4.47|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, hypertension, diuretic use, diabetes, neuropathic pain, and epilepsy."|||4.47|0.38|0.6722
72411057|NCT01138124|144330489|SUPERIORITY_OR_OTHER||Unadjusted Odds Ratio|3.24|||<|0.0001|TWO_SIDED|95.0|1.79|5.85|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag)."|||5.85|1.79|<0.0001
72411058|NCT01138124|144330489|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|2.9||||0.0005|TWO_SIDED|95.0|1.59|5.28|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, hypertension, diuretic use, diabetes, neuropathic pain, and epilepsy."|||5.28|1.59|0.0005
72411059|NCT01138124|144330489|SUPERIORITY_OR_OTHER||Unadjusted Odds Ratio|2.54||||0.042|TWO_SIDED|95.0|1.03|6.25|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag)."|||6.25|1.03|0.042
72411060|NCT01138124|144330489|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|2.4||||0.0603|TWO_SIDED|95.0|0.96|5.98|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, hypertension, diuretic use, diabetes, neuropathic pain, and epilepsy."|||5.98|0.96|0.0603
72411061|NCT01138124|144330489|SUPERIORITY_OR_OTHER||Unadjusted Odds Ratio|1.35||||0.3762|TWO_SIDED|95.0|0.69|2.65|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag)."|||2.65|0.69|0.3762
72329460|NCT03037476|144184383|OTHER|General Linear Model|Slope|-0.1816||||0.151|TWO_SIDED|95.0|-0.4295|0.0663|||Mixed Models Analysis|Negative binomial regression||Change in ASSIST Score over time: 6 month follow up||0.0663|-0.4295|0.151
72543342|NCT00219557|144616973|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.24|||||TWO_SIDED|95.0|-7.62|40.1||||||For change in appetite loss at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.||40.1|-7.62|
72411062|NCT01138124|144330489|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.33||||0.4073|TWO_SIDED|95.0|0.68|2.63|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, hypertension, diuretic use, diabetes, neuropathic pain, and epilepsy."|||2.63|0.68|0.4073
72543343|NCT00219557|144616973|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.76|||||TWO_SIDED|95.0|-17.49|23.02||||||For change in constipation at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.||23.02|-17.49|
72543344|NCT00219557|144616973|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.87|||||TWO_SIDED|95.0|-16.29|22.03||||||For change in diarrhea at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.||22.03|-16.29|
72543345|NCT00219557|144616973|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.56|||||TWO_SIDED|95.0|-9.81|20.92||||||For change in financial difficulties at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.||20.92|-9.81|
72543346|NCT00219557|144616973|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.97|||||TWO_SIDED|95.0|-19.52|7.57||||||For change in global QoL at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.||7.57|-19.52|
72543347|NCT00219557|144616973|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.64|||||TWO_SIDED|95.0|-19.75|8.46||||||For change in physical functioning at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.||8.46|-19.75|
72543348|NCT00219557|144616973|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.53|||||TWO_SIDED|95.0|-39.11|4.05||||||For change in role functioning at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.||4.05|-39.11|
72543349|NCT00219557|144616973|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.25|||||TWO_SIDED|95.0|-26.5|2.0||||||For change in emotional functioning at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.||2.00|-26.5|
72543350|NCT00219557|144616973|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.99|||||TWO_SIDED|95.0|-23.13|9.15||||||For change in cognitive functioning at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.||9.15|-23.13|
72543351|NCT00219557|144616973|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.09|||||TWO_SIDED|95.0|-30.48|16.31||||||For change in social functioning at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.||16.31|-30.48|
72543352|NCT00219557|144616973|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.88|||||TWO_SIDED|95.0|-5.86|27.63||||||For change in fatigue at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.||27.63|-5.86|
72543353|NCT00219557|144616973|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.1|||||TWO_SIDED|95.0|-24.11|1.91||||||For change in nausea and vomiting at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.||1.91|-24.11|
72543354|NCT00219557|144616973|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.13|||||TWO_SIDED|95.0|-24.26|14.0||||||For change in pain at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.||14.00|-24.26|
72543355|NCT00219557|144616973|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.13|||||TWO_SIDED|95.0|-14.18|24.44||||||For change in dyspnea at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.||24.44|-14.18|
72543356|NCT00219557|144616973|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.33|||||TWO_SIDED|95.0|-26.25|13.59||||||For change in insomnia at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.||13.59|-26.25|
72543357|NCT00219557|144616973|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.03|||||TWO_SIDED|95.0|-15.26|33.32||||||For change in appetite loss at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.||33.32|-15.26|
72543358|NCT00219557|144616973|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.56|||||TWO_SIDED|95.0|-25.71|26.82||||||For change in constipation at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.||26.82|-25.71|
72543359|NCT00219557|144616973|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.97|||||TWO_SIDED|95.0|-24.07|28.01||||||For change in diarrhea at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.||28.01|-24.07|
72329461|NCT03037476|144184383|OTHER|General Linear Model|Slope|-0.0601||||0.642|TWO_SIDED|95.0|-0.3133|0.1931|||Mixed Models Analysis|Negative Binomial Regression||Changes in ASSIST scores at 12 month follow up||0.1931|-0.3133|0.642
72543360|NCT00219557|144616973|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.48|||||TWO_SIDED|95.0|-5.89|24.86||||||For change in financial difficulties at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.||24.86|-5.89|
72543361|NCT00219557|144616973|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-20.01|||||TWO_SIDED|95.0|-43.19|3.17||||||For change in global QoL at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.||3.17|-43.19|
72543362|NCT00219557|144616973|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.57|||||TWO_SIDED|95.0|-27.24|10.1||||||For change in physical functioning at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.||10.10|-27.24|
72543363|NCT00219557|144616973|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.07|||||TWO_SIDED|95.0|-41.1|8.96||||||For change in role functioning at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.||8.96|-41.10|
72543364|NCT00219557|144616973|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-24.11|||||TWO_SIDED|95.0|-42.72|-5.5||||||For change in emotional functioning at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.||-5.50|-42.72|
72543365|NCT00219557|144616973|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.52|||||TWO_SIDED|95.0|-29.66|10.61||||||For change in cognitive functioning at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.||10.61|-29.66|
72411063|NCT01138124|144330489|SUPERIORITY_OR_OTHER||Unadjusted Odds Ratio|0.95||||0.9294|TWO_SIDED|95.0|0.29|3.12|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag)."|||3.12|0.29|0.9294
72329462|NCT03037476|144184384|OTHER|General Linear Model|Slope|-0.2177||||0.074|TWO_SIDED|95.0|-0.4566|0.0213|||Mixed Models Analysis|Negative Binomial Regression||Change in consequence score at 6 month follow up||0.0213|-0.4566|0.074
72411064|NCT01138124|144330489|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|0.99||||0.9875|TWO_SIDED|95.0|0.3|3.29|||Wilcoxon (Mann-Whitney)||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, hypertension, diuretic use, diabetes, neuropathic pain, and epilepsy."|||3.29|0.3|0.9875
72411065|NCT01138124|144330489|SUPERIORITY_OR_OTHER||Unadjusted Odds Ratio|1.19||||0.66|TWO_SIDED|95.0|0.54|2.63|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag)."|||2.63|0.54|0.66
72411066|NCT01138124|144330489|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.1||||0.811|TWO_SIDED|95.0|0.5|2.45|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, hypertension, diuretic use, diabetes, neuropathic pain, and epilepsy."|||2.45|0.5|0.8110
72543366|NCT00219557|144616973|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-20.24|||||TWO_SIDED|95.0|-47.93|7.46||||||For change in social functioning at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.||7.46|-47.93|
72543367|NCT00219557|144616973|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|25.0|||||TWO_SIDED|95.0|3.23|46.77||||||For change in fatigue at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.||46.77|3.23|
72543368|NCT00219557|144616973|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.25|||||TWO_SIDED|95.0|-13.49|25.99||||||For change in nausea and vomiting at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.||25.99|-13.49|
72543369|NCT00219557|144616973|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|19.64|||||TWO_SIDED|95.0|-7.12|46.41||||||For change in pain at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.||46.41|-7.12|
72543370|NCT00219557|144616973|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|22.02|||||TWO_SIDED|95.0|0.38|43.66||||||For change in dyspnea at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.||43.66|0.38|
72543371|NCT00219557|144616973|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.12|||||TWO_SIDED|95.0|-18.49|38.73||||||For change in insomnia at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.||38.73|-18.49|
72543372|NCT00219557|144616973|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|20.83|||||TWO_SIDED|95.0|-13.98|55.65||||||For change in appetite loss at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.||55.65|-13.98|
72543373|NCT00219557|144616973|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.9|||||TWO_SIDED|95.0|-19.02|42.83||||||For change in constipation at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.||42.83|-19.02|
72543374|NCT00219557|144616973|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.9|||||TWO_SIDED|95.0|-16.13|39.94||||||For change in diarrhea at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.||39.94|-16.13|
72543375|NCT00219557|144616973|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|||||TWO_SIDED|95.0|-23.38|23.38||||||For change in financial difficulties at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.||23.38|-23.38|
72543376|NCT00219557|144616973|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.66|||||TWO_SIDED|95.0|-34.53|17.21||||||For change in global QoL at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups||17.21|-34.53|
72543377|NCT00219557|144616973|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.98|||||TWO_SIDED|95.0|-52.01|26.04||||||For change in physical functioning at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.||26.04|-52.01|
72543378|NCT00219557|144616973|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-26.32|||||TWO_SIDED|95.0|-71.87|19.24||||||For change in role functioning at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.||19.24|-71.87|
72543379|NCT00219557|144616973|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.14|||||TWO_SIDED|95.0|-26.59|14.31||||||For change in emotional functioning at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.||14.31|-26.59|
72543380|NCT00219557|144616973|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.99|||||TWO_SIDED|95.0|-35.46|11.48||||||For change in cognitive functioning at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.||11.48|-35.46|
72543381|NCT00219557|144616973|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.04|||||TWO_SIDED|95.0|-20.97|49.04||||||For change in social functioning at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.||49.04|-20.97|
72543382|NCT00219557|144616973|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|23.39|||||TWO_SIDED|95.0|-15.83|62.61||||||For change in fatigue at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.||62.61|-15.83|
72543383|NCT00219557|144616973|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.95|||||TWO_SIDED|95.0|-30.84|38.73||||||For change in nausea and vomiting at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.||38.73|-30.84|
72543384|NCT00219557|144616973|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|24.56|||||TWO_SIDED|95.0|-13.08|62.2||||||For change in pain at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.||62.20|-13.08|
72543385|NCT00219557|144616973|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.85|||||TWO_SIDED|95.0|-38.65|34.94||||||For change in dyspnea at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.||34.94|-38.65|
72543386|NCT00219557|144616973|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.65|||||TWO_SIDED|95.0|-37.43|56.73||||||For change in insomnia at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.||56.73|-37.43|
72543387|NCT00219557|144616973|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.16|||||TWO_SIDED|95.0|-71.22|97.54||||||For change in appetite loss at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.||97.54|-71.22|
72543388|NCT00219557|144616973|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|22.81|||||TWO_SIDED|95.0|-22.61|68.22||||||For change in constipation at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.||68.22|-22.61|
72411067|NCT01138124|144330489|SUPERIORITY_OR_OTHER||Unadjusted Odds Ratio|1.7||||0.3336|TWO_SIDED|95.0|0.58|4.96|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag)."|||4.96|0.58|0.3336
72329463|NCT03037476|144184384|OTHER|General Linear Model|Slope|-0.1165||||0.351|TWO_SIDED|95.0|-0.3612|0.1282|||Mixed Models Analysis|Negative Binomial Regression||Change in consequence score at 12 month follow up||0.1282|-0.3612|0.351
72411068|NCT01138124|144330489|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.63||||0.3782|TWO_SIDED|95.0|0.55|4.84|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, hypertension, diuretic use, diabetes, neuropathic pain, and epilepsy."|||4.84|0.55|0.3782
72411069|NCT01138124|144330490|SUPERIORITY_OR_OTHER||Unadjusted Odds Ratio|1.89||||0.0841|TWO_SIDED|95.0|0.92|3.88|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag)."|||3.88|0.92|0.0841
72411070|NCT01138124|144330490|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.75||||0.1313|TWO_SIDED|95.0|0.85|3.63|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, hypertension, diuretic use, diabetes, neuropathic pain, and epilepsy."|||3.63|0.85|0.1313
72411071|NCT01138124|144330490|SUPERIORITY_OR_OTHER||Unadjusted Odds Ratio|2.03||||0.1488|TWO_SIDED|95.0|0.78|5.34|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag)."|||5.34|0.78|0.1488
72411072|NCT01138124|144330490|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|2.05||||0.1495|TWO_SIDED|95.0|0.77|5.46|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, hypertension, diuretic use, diabetes, neuropathic pain, and epilepsy."|||5.46|0.77|0.1495
72411073|NCT01138124|144330490|SUPERIORITY_OR_OTHER||Unadjusted Odds Ratio|2.44||||0.0013|TWO_SIDED|95.0|1.42|4.22|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag)."|||4.22|1.42|0.0013
72411074|NCT01138124|144330490|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|2.34||||0.0026|TWO_SIDED|95.0|1.35|4.07|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, hypertension, diuretic use, diabetes, neuropathic pain, and epilepsy."|||4.07|1.35|0.0026
72411075|NCT01138124|144330490|SUPERIORITY_OR_OTHER||Unadjusted Odds Ratio|1.78||||0.2421|TWO_SIDED|95.0|0.68|4.69|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag)."|||4.69|0.68|0.2421
72411076|NCT01138124|144330490|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.7||||0.2899|TWO_SIDED|95.0|0.64|4.53|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, hypertension, diuretic use, diabetes, neuropathic pain, and epilepsy."|||4.53|0.64|0.2899
72543389|NCT00219557|144616973|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.75|||||TWO_SIDED|95.0|-39.1|35.59||||||For change in diarrhea at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.||35.59|-39.10|
72543390|NCT00219557|144616973|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|23.98|||||TWO_SIDED|95.0|1.09|46.86||||||For change in financial difficulties at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.||46.86|1.09|
72543391|NCT00219557|144616973|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.04|||||TWO_SIDED|95.0|-39.03|63.11||||||For change in global QoL at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.||63.11|-39.03|
72543392|NCT00219557|144616973|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|18.89|||||TWO_SIDED|95.0|-20.74|58.52||||||For change in physical functioning at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.||58.52|-20.74|
72543393|NCT00219557|144616973|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-48.33|||||TWO_SIDED|95.0|-111.94|15.28||||||For change in role functioning at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.||15.28|-111.94|
72543394|NCT00219557|144616973|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.93|||||TWO_SIDED|95.0|-22.59|20.74||||||For change in emotional functioning at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.||20.74|-22.59|
72543395|NCT00219557|144616973|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.22|||||TWO_SIDED|95.0|-24.98|39.43||||||For change in cognitive functioning at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.||39.43|-24.98|
72543396|NCT00219557|144616973|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.0|||||TWO_SIDED|95.0|-57.71|77.71||||||For change in social functioning at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.||77.71|-57.71|
72543397|NCT00219557|144616973|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.04|||||TWO_SIDED|95.0|-58.87|24.79||||||For change in fatigue at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.||24.79|-58.87|
72543398|NCT00219557|144616973|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.0|||||TWO_SIDED|95.0|-43.1|13.1||||||For change in nausea and vomiting at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.||13.10|-43.10|
72543399|NCT00219557|144616973|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.78|||||TWO_SIDED|95.0|-41.75|57.3||||||For change in pain at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.||57.30|-41.75|
72411077|NCT01138124|144330490|SUPERIORITY_OR_OTHER||Unadjusted Odds Ratio|0.99||||0.9723|TWO_SIDED|95.0|0.42|2.29|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag)."|||2.29|0.42|0.9723
72411078|NCT01138124|144330490|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|0.91||||0.8206|TWO_SIDED|95.0|0.39|2.13|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, hypertension, diuretic use, diabetes, neuropathic pain, and epilepsy."|||2.13|0.39|0.8206
72411079|NCT01138124|144330490|SUPERIORITY_OR_OTHER||Unadjusted Odds Ratio|1.15||||0.8135|TWO_SIDED|95.0|0.35|3.82|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag)."|||3.82|0.35|0.8135
72411080|NCT01138124|144330490|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.15||||0.8173|TWO_SIDED|95.0|0.34|3.86|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, hypertension, diuretic use, diabetes, neuropathic pain, and epilepsy."|||3.86|0.34|0.8173
72411081|NCT00575588|144330514|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.06|STANDARD_ERROR_OF_MEAN|0.053|||TWO_SIDED|95.0|-0.05|0.16||||||||0.16|-0.05|
72411082|NCT00575588|144330515|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-33.2|||<|0.0001|TWO_SIDED|95.0|-38.1|-28.5||Between group comparison significant after controlling overall alpha of the study|Fisher Exact|||||-28.5|-38.1|<0.0001
72411083|NCT00575588|144330516|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.2|STANDARD_ERROR_OF_MEAN|0.24|<|0.0001||95.0|-2.7|-1.7||Between group comparison significant after controlling overall alpha of the study|ANCOVA|||||-1.7|-2.7|<0.0001
72543400|NCT00219557|144616973|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.67|||||TWO_SIDED|95.0|-53.79|20.46||||||For change in dyspnea at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.||20.46|-53.79|
72543401|NCT00219557|144616973|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-21.11|||||TWO_SIDED|95.0|-73.14|30.92||||||For change in insomnia at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.||30.92|-73.14|
72543402|NCT00219557|144616973|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-32.22|||||TWO_SIDED|95.0|-115.58|51.13||||||For change in appetite loss at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.||51.13|-115.58|
72543403|NCT00219557|144616973|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|53.33|||||TWO_SIDED|95.0|-18.6|125.26||||||For change in constipation at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.||125.26|-18.60|
72543404|NCT00219557|144616973|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.33|||||TWO_SIDED|95.0|-34.92|41.58||||||For change in diarrhea at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.||41.58|-34.92|
72543405|NCT00219557|144616973|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.67|||||TWO_SIDED|95.0|-34.3|20.96||||||For change in financial difficulties at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.||20.96|-34.3|
72543406|NCT00219557|144616973|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|20.83|||||TWO_SIDED|95.0|-58.94|100.6||||||For change in global QoL at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.||100.60|-58.94|
72543407|NCT00219557|144616973|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.33|||||TWO_SIDED|95.0|-44.54|63.2||||||For change in physical functioning at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.||63.20|-44.54|
72543408|NCT00219557|144616973|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|20.0|||||TWO_SIDED|95.0|-35.3|75.3||||||For change in role functioning at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.||75.30|-35.30|
72543409|NCT00219557|144616973|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.5|||||TWO_SIDED|95.0|-51.66|36.66||||||For change in emotional functioning at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.||36.66|-51.66|
72543410|NCT00219557|144616973|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.67|||||TWO_SIDED|95.0|-36.06|69.39||||||For change in cognitive functioning at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.||69.39|-36.06|
72543411|NCT00219557|144616973|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.0|||||TWO_SIDED|95.0|-76.36|86.36||||||For change in social functioning at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.||86.36|-76.36|
72411084|NCT00575588|144330517|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.002|STANDARD_ERROR_OF_MEAN|0.001||0.04|TWO_SIDED|95.0|-0.0046|-0.0001||Between group comparison significant after controlling overall alpha of the study|Mixed Models Analysis|||||-0.0001|-0.0046|0.040
72411085|NCT00575588|144330518|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.05|STANDARD_ERROR_OF_MEAN|0.059|||TWO_SIDED|95.0|-0.17|0.06|||Repeated Measures|||||0.06|-0.17|
72411086|NCT00575588|144330519|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-34.9|||||TWO_SIDED|95.0|-39.8|-30.0||||||||-30.0|-39.8|
72411087|NCT00575588|144330520|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.76|STANDARD_ERROR_OF_MEAN|0.286|||TWO_SIDED|95.0|-3.32|-2.2|||Repeated Measures|||||-2.20|-3.32|
72543412|NCT00219557|144616973|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.78|||||TWO_SIDED|95.0|-77.63|42.08||||||For change in fatigue at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.||42.08|-77.63|
72543413|NCT00219557|144616973|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.67|||||TWO_SIDED|95.0|-62.33|28.99||||||For change in nausea and vomiting at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.||28.99|-62.33|
72543414|NCT00219557|144616973|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.33|||||TWO_SIDED|95.0|-79.59|96.26||||||For change in pain at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.||96.26|-79.59|
72543415|NCT00219557|144616973|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-18.52|||||TWO_SIDED|95.0|-89.98|52.94||||||For change in dyspnea at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.||52.94|-89.98|
72543416|NCT00219557|144616973|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-20.0|||||TWO_SIDED|95.0|-133.08|93.08||||||For change in insomnia at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.||93.08|-133.08|
72543417|NCT00219557|144616973|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-36.67|||||TWO_SIDED|95.0|-151.27|77.94||||||For change in appetite loss at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.||77.94|-151.27|
72543418|NCT00219557|144616973|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.33|||||TWO_SIDED|95.0|-72.58|65.91||||||For change in constipation at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.||65.91|-72.58|
72543419|NCT00219557|144616973|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|73.33|||||TWO_SIDED|95.0|-16.45|163.12||||||For change in diarrhea at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.||163.12|-16.45|
72543420|NCT00219557|144616973|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.33|||||TWO_SIDED|95.0|-48.23|41.56||||||For change in financial difficulties at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.||41.56|-48.23|
72411088|NCT00575588|144330521|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.0035|STANDARD_ERROR_OF_MEAN|0.0007|||TWO_SIDED|95.0|-0.0048|-0.0022|||Mixed Models Analysis|||||-0.0022|-0.0048|
72411089|NCT01854827|144330524|SUPERIORITY|Percent was evaluated relative to 80% where statistical superiority was demonstrated if the one-sided, 90% Clopper-Pearson lower confidence bound was \> 80%.|Percent of patients|79.3|||||ONE_SIDED|90.0|63.2||||||||The lower bound of the 90% Clopper-Pearson confidence interval was \< 80%, therefore the study failed to achieve the feasibility definition stated in the protocol.||63.2|
72411090|NCT01854827|144330525|SUPERIORITY|Percent was evaluated relative to 80% where statistical superiority was demonstrated if the one-sided, 90% Clopper-Pearson lower confidence bound was \> 80%.|Percent of patients|79.3|||||ONE_SIDED|90.0|63.2||||||||The lower bound of the 90% Clopper-Pearson confidence interval was \< 80%, therefore the study failed to achieve the feasibility definition stated in the protocol.||63.2|
72411091|NCT01854827|144330526|OTHER|Percents with serious AEs prior to liver transplant were calculated, along with one-sided 90% Clopper-Pearson confidence interval lower bounds.|Percent of patients|89.7|||||ONE_SIDED|90.0|75.4||||||||||75.4|
72411092|NCT01854827|144330527|OTHER|Percent of patients with level 3-5 toxicity are presented along with one-sided 90% Clopper-Pearson confidence interval lower bound.|Percent of patients|89.7|||||ONE_SIDED|90.0|75.4||||||||||75.4|
72411093|NCT01854827|144330528|OTHER|Percent of patients with other expected AEs are presented along with one-sided 90% Clopper-Pearson confidence limit lower bound.|Percent of patients|27.6|||||ONE_SIDED|90.0|14.5||||||||||14.5|
72411094|NCT01854827|144330529|SUPERIORITY|One-sided testing for superiority of IVIG to historical control.|Odds Ratio (OR)|0.67||||0.5486|ONE_SIDED|90.0||2.38|||Regression, Logistic|||IVIG was compared to the historical placebo control from the START study (n=64): PMID: 24794368 NCT00294684||2.38||0.5486
72411095|NCT01854827|144330530|SUPERIORITY|One-sided testing for superiority of IVIG relative to historical control.|Odds Ratio (OR)|0.33||||0.8455|ONE_SIDED|90.0||1.22|||Regression, Logistic|||IVIG was compared for superiority to the historical control of START study placebo (N=64). PMID: 24794368 NCT00294684||1.22||0.8455
72411096|NCT01854827|144330531|SUPERIORITY|One-sided.|Odds Ratio (OR)|0.29||||0.8431|ONE_SIDED|90.0||1.24||One-sided|Regression, Logistic|||IVIG was compared for superiority to the historical START placebo control (N=64).||1.24||0.8431
72411097|NCT01854827|144330532|SUPERIORITY|One-sided for IVIG superior to historical START placebo control. PMID: 24794368 NCT00294684|Risk Difference (RD)|-11.9|||||ONE_SIDED|90.0||2.1||||||K-M estimates for survival for IVIG vs the historical START placebo control are provided, along with one-sided 90% upper bounds of the confidence intervals.||2.1||
72543421|NCT00219557|144616973|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|15.62|||||TWO_SIDED|95.0|-74.75|106.0||||||For change in global QoL at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.||106.00|-74.75|
72543422|NCT00219557|144616973|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|33.33|||||TWO_SIDED|95.0|-17.22|83.89||||||For change in physical functioning at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.||83.89|-17.22|
72543423|NCT00219557|144616973|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.17|||||TWO_SIDED|95.0|-58.04|66.37||||||For change in role functioning at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.||66.37|-58.04|
72543424|NCT00219557|144616973|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.21|||||TWO_SIDED|95.0|-28.19|38.61||||||For change in emotional functioning at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.||38.61|-28.19|
72543425|NCT00219557|144616973|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|31.25|||||TWO_SIDED|95.0|-40.94|103.44||||||For change in cognitive functioning at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.||103.44|-40.94|
72543426|NCT00219557|144616973|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|27.08|||||TWO_SIDED|95.0|-91.02|145.18||||||For change in social functioning at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.||145.18|-91.02|
72543427|NCT00219557|144616973|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.28|||||TWO_SIDED|95.0|-99.46|68.9||||||For change in fatigue at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.||68.90|-99.46|
72543428|NCT00219557|144616973|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-25.0|||||TWO_SIDED|95.0|-69.69|19.69||||||For change in nausea and vomiting at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.||19.69|-69.69|
72543429|NCT00219557|144616973|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|||||TWO_SIDED|95.0|-77.4|77.4||||||For change in pain at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.||77.40|-77.40|
72543430|NCT00219557|144616973|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.29|||||TWO_SIDED|95.0|-82.89|54.32||||||For change in dyspnea at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.||54.32|-82.89|
72543431|NCT00219557|144616973|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.17|||||TWO_SIDED|95.0|-87.02|78.69||||||For change in insomnia at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.||78.69|-87.02|
72543432|NCT00219557|144616973|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-25.0|||||TWO_SIDED|95.0|-184.57|134.57||||||For change in appetite loss at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.||134.57|-184.57|
72543433|NCT00219557|144616973|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.33|||||TWO_SIDED|95.0|-105.73|89.06||||||For change in constipation at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.||89.06|-105.73|
72543434|NCT00219557|144616973|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|79.17|||||TWO_SIDED|95.0|-29.72|188.06||||||For change in diarrhea at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.||188.06|-29.72|
72329464|NCT03037476|144184385|OTHER|General Linear Model|Slope|0.044||||0.255|TWO_SIDED|95.0|-0.032|0.1197|||Mixed Models Analysis|Negative Binomial Regression||Change in peak alcohol quantity at 6 months (reported by number of standard drinks)||0.1197|-0.032|0.255
72543435|NCT00219557|144616973|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.17|||||TWO_SIDED|95.0|-57.74|49.41||||||For change in financial difficulties at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.||49.41|-57.74|
72543436|NCT00219557|144616973|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.67|||||TWO_SIDED|95.0|-39.62|72.95||||||For change in global QoL at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.||72.95|-39.62|
72543437|NCT00219557|144616973|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|27.62|||||TWO_SIDED|95.0|-6.42|61.66||||||For change in physical functioning at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.||61.66|-6.42|
72543438|NCT00219557|144616973|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|26.19|||||TWO_SIDED|95.0|-29.28|81.66||||||For change in role functioning at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.||81.66|-29.28|
72543439|NCT00219557|144616973|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.57|||||TWO_SIDED|95.0|-63.74|56.6||||||For change in emotional functioning at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.||56.6|-63.74|
72543440|NCT00219557|144616973|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|23.81|||||TWO_SIDED|95.0|-31.66|79.28||||||For change in cognitive functioning at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.||79.28|-31.66|
72543441|NCT00219557|144616973|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|28.57|||||TWO_SIDED|95.0|-53.82|110.96||||||For change in social functioning at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.||110.96|-53.82|
72543442|NCT00219557|144616973|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-30.16|||||TWO_SIDED|95.0|-94.53|34.21||||||For change in fatigue at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.||34.21|-94.53|
72543443|NCT00219557|144616973|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.67|||||TWO_SIDED|95.0|-83.26|49.93||||||For change in nausea and vomiting at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.||49.93|-83.26|
72543444|NCT00219557|144616973|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.76|||||TWO_SIDED|95.0|-97.98|88.45||||||For change in pain at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.||88.45|-97.98|
72411098|NCT02571452|144330534|SUPERIORITY||Mean Difference (Net)|-3.6|STANDARD_ERROR_OF_MEAN|1.53||0.021|TWO_SIDED|95.0|-6.65|-0.55||The threshold for statistical significance was p=.05.|Mixed Models Analysis|||||-0.55|-6.65|.021
72411099|NCT02571452|144330535|SUPERIORITY||Mean Difference (Net)|0.52|STANDARD_ERROR_OF_MEAN|0.57||0.568|TWO_SIDED|95.0|-1.26|2.3||The threshold for statistical significance was p=.05.|Mixed Models Analysis|||||2.30|-1.26|.568
72411100|NCT02571452|144330536|SUPERIORITY||Mean Difference (Net)|-4.1|STANDARD_ERROR_OF_MEAN|0.89|<|0.001|TWO_SIDED|95.0|-5.87|-2.33||The threshold for statistical significance was p=.05.|Mixed Models Analysis|||||-2.33|-5.87|<.001
72411101|NCT02571452|144330537|SUPERIORITY||Mean Difference (Net)|-0.66|STANDARD_ERROR_OF_MEAN|0.49||0.173|TWO_SIDED|95.0|-1.61|0.29||The threshold for statistical significance was p=.05.|Mixed Models Analysis|||||0.29|-1.61|.173
72411102|NCT02660944|144330553|SUPERIORITY|Two-sample t-test with Satterthwaite approximation|Mean Difference (Final Values)|0.37||||0.845|TWO_SIDED|95.0|-3.42|4.15|||t-test, 2 sided|||Change from baseline at Day 85 RSLV-132 versus placebo||4.15|-3.42|0.845
72543445|NCT00219557|144616973|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.11|||||TWO_SIDED|95.0|-86.68|64.46||||||For change in dyspnea at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.||64.46|-86.68|
72543446|NCT00219557|144616973|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.76|||||TWO_SIDED|95.0|-55.41|64.93||||||For change in insomnia at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.||64.93|-55.41|
72543447|NCT00219557|144616973|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.52|||||TWO_SIDED|95.0|-129.86|110.82||||||For change in appetite loss at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.||110.82|-129.86|
72411103|NCT02660944|144330553|SUPERIORITY|Two-sample t-test with Satterthwaite approximation|Mean Difference (Final Values)|-0.48||||0.818|TWO_SIDED|95.0|-4.66|3.7|||t-test, 2 sided|||Change from baseline at Day 169 RSLV-132 versus placebo||3.70|-4.66|0.818
72543448|NCT00219557|144616973|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.05|||||TWO_SIDED|95.0|-117.92|79.82||||||For change in constipation at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.||79.82|-117.92|
72543449|NCT00219557|144616973|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|76.19|||||TWO_SIDED|95.0|-6.75|159.13||||||For change in diarrhea at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.||159.13|-6.75|
72543450|NCT00219557|144616973|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.76|||||TWO_SIDED|95.0|-64.93|55.41||||||For change in financial difficulties at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.||55.41|-64.93|
72543451|NCT00219557|144616973|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.56|||||TWO_SIDED|95.0|-271.74|260.62||||||For change in global QoL at Cycle 11 Day 1, mean change difference was used to compare the two treatment groups.||260.62|-271.74|
72421527|NCT01342458|144354202|SUPERIORITY_OR_OTHER|||||||0.425|TWO_SIDED||||||Mixed Models Analysis|||We used a casewise two-way ANOVA for repeated measures (two independent groups and three repeated measures/assessments), followed by a post hoc Newman-Keuls test to verify the interaction effect of group vs. time between T0 (baseline), T3 (3th month) and T6 (6th month).||||0.425
72543452|NCT00219557|144616973|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|15.56|||||TWO_SIDED|95.0|-166.87|197.98||||||For change in physical functioning at Cycle 11 Day 1, mean change difference was used to compare the two treatment groups.||197.98|-166.87|
72543453|NCT00219557|144616973|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|27.78|||||TWO_SIDED|95.0|-238.4|293.96||||||For change in role functioning at Cycle 11 Day 1, mean change difference was used to compare the two treatment groups.||293.96|-238.4|
72543454|NCT00219557|144616973|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.67|||||TWO_SIDED|95.0|-275.22|241.89||||||For change in emotional functioning at Cycle 11 Day 1, mean change difference was used to compare the two treatment groups.||241.89|-275.22|
72543455|NCT00219557|144616973|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.56|||||TWO_SIDED|95.0|-307.94|319.05||||||For change in cognitive functioning at Cycle 11 Day 1, mean change difference was used to compare the two treatment groups.||319.05|-307.94|
72543456|NCT00219557|144616973|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|27.78|||||TWO_SIDED|95.0|-238.4|293.96||||||For change in social functioning at Cycle 11 Day 1, mean change difference was used to compare the two treatment groups.||293.96|-238.40|
72543457|NCT00219557|144616973|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.81|||||TWO_SIDED|95.0|-215.01|244.64||||||For change in fatigue at Cycle 11 Day 1, mean change difference was used to compare the two treatment groups.||244.64|-215.01|
72543458|NCT00219557|144616973|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.11|||||TWO_SIDED|95.0|-302.38|324.6||||||For change in nausea and vomiting at Cycle 11 Day 1, mean change difference was used to compare the two treatment groups.||324.60|-302.38|
72421528|NCT01342458|144354203|SUPERIORITY_OR_OTHER|||||||0.443|TWO_SIDED||||||Mixed Models Analysis|||We used a casewise two-way ANOVA for repeated measures (two independent groups and three repeated measures/assessments), followed by a post hoc Newman-Keuls test to verify the interaction effect of group vs. time between T0 (baseline), T3 (3th month) and T6 (6th month).||||0.443
72421529|NCT01342458|144354204|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|10.0|||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Difference in paracetamol intake at 6-month.||||<0.001
72543459|NCT00219557|144616973|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|38.89|||||TWO_SIDED|95.0|-305.85|383.63||||||For change in pain at Cycle 11 Day 1, mean change difference was used to compare the two treatment groups.||383.63|-305.85|
72329465|NCT03037476|144184385|OTHER|General Linear Model|Slope|0.0315||||0.428|TWO_SIDED|95.0|-0.0463|0.1092|||Mixed Models Analysis|Negative Binomial Regression||Change in peak alcohol quantity (reported in standard drinks) at 12 month follow-up||0.1092|-0.0463|0.428
72411104|NCT00534352|144330557|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence was shown for Cmin as the 90% confidence intervals (CI) of the LSmean ratio was within the 80-125% limits.|Least Square (LS) mean ratio|95.47||||||90.0|82.77|110.1||No p-values.|Mixed Models Analysis (Cmin)|The linear mixed effects model was controlled for treatment as fixed effects, and subject as a random effect.|The results are for the mean ratio of Cmin. Numerator: Treatment B Denominator: Treatment A|Previous studies showed that the intrasubject variability on the log transformed Cmax and AUC12h of TMC125 was less than or equal to 40%. Based on this and with complete data on 20 patients, the 90% CI of the true ratio of the means was expected to be contained within 81-124% of the observed ratio of the means.||110.1|82.77|
72411105|NCT00534352|144330557|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence was shown for Cmax as the 90% confidence intervals (CI) of the LSmean ratio was within the 80-125% limits.|Least Square (LS) mean ratio|102.6||||||90.0|92.91|113.3||No p-values.|Mixed Models Analysis (Cmax)|The linear mixed effects model was controlled for treatment as fixed effects, and subject as a random effect.|The results are for the mean ratio of Cmax. Numerator: Treatment B Denominator: Treatment A|Previous studies showed that the intrasubject variability on the log transformed Cmax and AUC12h of TMC125 was less than or equal to 40%. Based on this and with complete data on 20 patients, the 90% CI of the true ratio of the means was expected to be contained within 81-124% of the observed ratio of the means.||113.3|92.91|
72411106|NCT00534352|144330557|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence was shown for AUC24 as the 90% confidence intervals (CI) of the LSmean ratio was within the 80-125% limits.|LS means of ratios|98.97||||||90.0|89.23|109.8||No p-values.|Mixed Models Analysis (AUC24)|The linear mixed effects model was controlled for treatment as fixed effects, and subject as a random effect.|The results are for the mean ratio of AUC24. Numerator: Treatment B Denominator: Treatment A|Previous studies showed that the intrasubject variability on the log transformed Cmax and AUC12h of TMC125 was less than or equal to 40%. Based on this and with complete data on 20 patients, the 90% CI of the true ratio of the means was expected to be contained within 81-124% of the observed ratio of the means.||109.8|89.23|
72411107|NCT00534352|144330557|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence was shown for Css,av as the 90% confidence intervals (CI) of the LSmean ratio was within the 80-125% limits.|Least Square (LS) mean ratio|99.3||||||90.0|89.39|110.3||No p-values.|Mixed Models Analysis (Css,av)|The linear mixed effects model was controlled for treatment as fixed effects, and subject as a random effect.|The results are for the mean ratio of Css,av. Numerator: Treatment B Denominator: Treatment A|Previous studies showed that the intrasubject variability on the log transformed Cmax and AUC12h of TMC125 was less than or equal to 40%. Based on this and with complete data on 20 patients, the 90% CI of the true ratio of the means was expected to be contained within 81-124% of the observed ratio of the means.||110.3|89.39|
72411108|NCT04796610|144330569|SUPERIORITY||Odds Ratio (OR)|0.55||||0.49|TWO_SIDED|95.0|0.1|2.98|||Regression, Logistic|Model is adjusted for participant age|Results are presented for an indicator where 0=control and 1=intervention|||2.98|.1|0.49
72329466|NCT03037476|144184386|OTHER|General Linear Model|Slope|0.0021||||0.966|TWO_SIDED|95.0|-0.0936|0.0978|||Mixed Models Analysis|Negative Binomial Regression||Change in DDQ score at 6 months||0.0978|-0.0936|0.966
72411109|NCT04796610|144330570|SUPERIORITY||Odds Ratio (OR)|16.82||||0.011|TWO_SIDED|95.0|1.93|146.91||Model is adjusted for participant age|Regression, Logistic||Results are presented for an indicator where 0=control and 1=intervention|||146.91|1.93|.011
72411110|NCT04796610|144330571|SUPERIORITY||Mean Difference (Final Values)|0.52||||0.03|TWO_SIDED|95.0|0.07|0.97|||Regression, Linear|Model is adjusted for participant age|Results are presented for an indicator where 0=control and 1=intervention|||0.97|0.07|.03
72543460|NCT00219557|144616973|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.11|||||TWO_SIDED|95.0|-355.85|333.63||||||For change in dyspnea at Cycle 11 Day 1, mean change difference was used to compare the two treatment groups.||333.63|-355.85|
72543461|NCT00219557|144616973|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|22.22|||||TWO_SIDED|95.0|-322.52|366.97||||||For change in insomnia at Cycle 11 Day 1, mean change difference was used to compare the two treatment groups.||366.97|-322.52|
72543462|NCT00219557|144616973|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|44.44|||||TWO_SIDED|95.0|-208.53|297.42||||||For change in appetite loss at Cycle 11 Day 1, mean change difference was used to compare the two treatment groups.||297.42|-208.53|
72543463|NCT00219557|144616973|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|||||TWO_SIDED|95.0|-165.61|165.61||||||For change in constipation at Cycle 11 Day 1, mean change difference was used to compare the two treatment groups.||165.61|-165.61|
72543464|NCT00219557|144616973|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|77.78|||||TWO_SIDED|95.0|-17.84|173.39||||||For change in diarrhea at Cycle 11 Day 1, mean change difference was used to compare the two treatment groups.||173.39|-17.84|
72543465|NCT00219557|144616973|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.11|||||TWO_SIDED|95.0|-106.73|84.5||||||For change in financial difficulties at Cycle 11 Day 1, mean change difference was used to compare the two treatment groups.||84.5|-106.73|
72543466|NCT00219557|144616973|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-54.17|||||TWO_SIDED|95.0|-512.66|404.33||||||For change in global QoL at EoS, mean change difference was used to compare the two treatment groups.||404.33|-512.66|
72543467|NCT00219557|144616973|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-70.0|||||TWO_SIDED|95.0|-143.36|3.36||||||For change in physical functioning at EoS, mean change difference was used to compare the two treatment groups.||3.36|-143.36|
72543468|NCT00219557|144616973|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-33.33|||||TWO_SIDED|95.0|-400.13|333.46||||||For change in role functioning at EoS, mean change difference was used to compare the two treatment groups.||333.46|-400.13|
72543469|NCT00219557|144616973|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-41.67|||||TWO_SIDED|95.0|-591.86|508.53||||||For change in emotional functioning at EoS, mean change difference was used to compare the two treatment groups.||508.53|-591.86|
72411111|NCT02059148|144330572|SUPERIORITY_OR_OTHER||Ratio of Geometric LSMeans|1.24|||||TWO_SIDED|90.0|1.11|1.38||||||||1.38|1.11|
72543470|NCT00219557|144616973|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-66.67|||||TWO_SIDED|95.0|-66.67|-66.67||||||For change in cognitive functioning at EoS, mean change difference was used to compare the two treatment groups.||-66.67|-66.67|
72543471|NCT00219557|144616973|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-83.33|||||TWO_SIDED|95.0|-450.13|283.46||||||For change in social functioning at EoS, mean change difference was used to compare the two treatment groups.||283.46|-450.13|
72543472|NCT00219557|144616973|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|66.67|||||TWO_SIDED|95.0|-177.86|311.2||||||For change in fatigue at EoS, mean change difference was used to compare the two treatment groups.||311.2|-177.86|
72543473|NCT00219557|144616973|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|33.33|||||TWO_SIDED|95.0|-333.46|400.13||||||For change in nausea and vomiting at EoS, mean change difference was used to compare the two treatment groups.||400.13|-333.46|
72543474|NCT00219557|144616973|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|25.0|||||TWO_SIDED|95.0|-1258.79|1308.79||||||For change in pain at EoS, mean change difference was used to compare the two treatment groups.||1308.79|-1258.79|
72543475|NCT00219557|144616973|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|83.33|||||TWO_SIDED|95.0|-283.46|450.13||||||For change in dyspnea at EoS, mean change difference was used to compare the two treatment groups.||450.13|-283.46|
72543476|NCT00219557|144616973|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|33.33|||||TWO_SIDED|95.0|-700.26|766.93||||||For change in insomnia at EoS, mean change difference was used to compare the two treatment groups.||766.93|-700.26|
72543477|NCT00219557|144616973|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|50.0|||||TWO_SIDED|95.0|-1050.39|1150.39||||||For change in appetite loss at EoS, mean change difference was used to compare the two treatment groups.||1150.39|-1050.39|
72543478|NCT00219557|144616973|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.67|||||TWO_SIDED|95.0|-1850.65|1817.32||||||For change in constipation at EoS, mean change difference was used to compare the two treatment groups.||1817.32|-1850.65|
72411112|NCT02059148|144330573|SUPERIORITY_OR_OTHER||Ratio of Geometric LSMeans|1.14|||||TWO_SIDED|90.0|1.05|1.23||||||||1.23|1.05|
72411113|NCT02059148|144330574|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|1.95||||0.0006|TWO_SIDED|90.0|1.0|2.0|||Wilcoxon (Mann-Whitney)|||||2.00|1.00|0.0006
72411114|NCT00403546|144330591|SUPERIORITY||Mean Difference (Final Values)|0.01||||0.98|TWO_SIDED|95.0|-1.09|1.12|||Mixed Models Analysis|||At Baseline||1.12|-1.09|0.980
72411115|NCT00403546|144330591|SUPERIORITY||Mean Difference (Net)|1.02||||0.033|TWO_SIDED|95.0|0.08|1.95|||Mixed Models Analysis|||At Week 2||1.95|0.08|0.033
72543479|NCT00219557|144616973|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|33.33|||||TWO_SIDED|95.0|-700.26|766.93||||||For change in diarrhea at EoS, mean change difference was used to compare the two treatment groups.||766.93|-700.26|
72543480|NCT00219557|144616973|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.67|||||TWO_SIDED|95.0|-383.46|350.13||||||For change in financial difficulties at EoS, mean change difference was used to compare the two treatment groups.||350.13|-383.46|
72543481|NCT00219557|144616974|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.59|||||TWO_SIDED|95.0|-10.11|15.29||||||For change in pancreatic pain at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.||15.29|-10.11|
72543482|NCT00219557|144616974|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.41|||||TWO_SIDED|95.0|-13.39|20.2||||||For change in eating related items at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.||20.20|-13.39|
72543483|NCT00219557|144616974|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|19.7|||||TWO_SIDED|95.0|5.96|33.43||||||For change in altered bowel habits at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.||33.43|5.96|
72543484|NCT00219557|144616974|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.7|||||TWO_SIDED|95.0|0.93|24.47||||||For change in jaundice at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.||24.47|0.93|
72543485|NCT00219557|144616974|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|15.1|||||TWO_SIDED|95.0|1.28|28.91||||||For change in body image at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.||28.91|1.28|
72543486|NCT00219557|144616974|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.36|||||TWO_SIDED|95.0|-14.59|23.3||||||For change in health care satisfaction at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.||23.30|-14.59|
72543487|NCT00219557|144616974|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-21.19|||||TWO_SIDED|95.0|-37.53|-4.85||||||For change in sexual functioning at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.||-4.85|-37.53|
72543488|NCT00219557|144616974|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.82|||||TWO_SIDED|95.0|-25.04|9.4||||||For change in ascites at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.||9.40|-25.04|
72543489|NCT00219557|144616974|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.95|||||TWO_SIDED|95.0|-9.59|21.5||||||For change in indigestion at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.||21.50|-9.59|
72543490|NCT00219557|144616974|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.39|||||TWO_SIDED|95.0|-1.61|30.4||||||For change in flatulence at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.||30.40|-1.61|
72578148|NCT00509795|144683829|SUPERIORITY_OR_OTHER||Differences in Least Squares means|-0.6||||0.5579|TWO_SIDED|95.1|-2.61|1.42||As adjustment of multiple comparisons, a conditional sequence of statistical hypotheses is used with alpha = 0.049|ANCOVA||The difference is calculated as IAI minus ranibizumab. A positive value favors IAI 2.0Q8.|The pairwise comparison is performed as contrast statement in the analysis of covariance model with treatment group as fixed factor (all 4 treatment groups) and the baseline measure as covariate. The null hypothesis is that both mean changes are equal.||1.42|-2.61|0.5579
72543491|NCT00219557|144616974|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.5|||||TWO_SIDED|95.0|2.78|22.22||||||For change in cachexia at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.||22.22|2.78|
72543492|NCT00219557|144616974|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.88|||||TWO_SIDED|95.0|1.36|20.39||||||For change in side effects at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.||20.39|1.36|
72543493|NCT00219557|144616974|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.33|||||TWO_SIDED|95.0|-16.36|11.71||||||For change in fear of future health at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.||11.71|-16.36|
72543494|NCT00219557|144616974|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.21|||||TWO_SIDED|95.0|-11.78|24.2||||||For change in ability to plan future at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.||24.20|-11.78|
72543495|NCT00219557|144616974|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.87|||||TWO_SIDED|95.0|0.79|28.94||||||For change in pancreatic pain at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.||28.94|0.79|
72329467|NCT03037476|144184386|OTHER|General Linear Model|Slope|-0.0559||||0.265|TWO_SIDED|95.0|-0.1542|0.0424|||Mixed Models Analysis|Negative Binomial Regression||Change in DDQ score at 12 month follow-up||0.0424|-0.1542|0.265
72411116|NCT00403546|144330591|SUPERIORITY||Mean Difference (Net)|0.73||||0.171|TWO_SIDED|95.0|-0.32|1.77|||Mixed Models Analysis|||At Week 4||1.77|-0.32|0.171
72411117|NCT00403546|144330591|SUPERIORITY||Mean Difference (Net)|0.5||||0.38|TWO_SIDED|95.0|-0.62|1.62|||Mixed Models Analysis|||At Week 6||1.62|-0.62|0.380
72411118|NCT00403546|144330591|SUPERIORITY||Mean Difference (Net)|-0.12||||0.84|TWO_SIDED|95.0|-1.32|1.08|||Mixed Models Analysis|||At Week 8||1.08|-1.32|0.840
72411119|NCT00403546|144330592|SUPERIORITY||Mean Difference (Final Values)|-0.18||||0.737|TWO_SIDED|95.0|-1.23|0.88|||Mixed Models Analysis|||At Baseline||0.88|-1.23|0.737
72411120|NCT00403546|144330592|SUPERIORITY||Mean Difference (Net)|-0.14||||0.764|TWO_SIDED|95.0|-1.09|0.8|||Mixed Models Analysis|||At Week 2||0.80|-1.09|0.764
72411121|NCT00403546|144330592|SUPERIORITY||Mean Difference (Net)|0.25||||0.642|TWO_SIDED|95.0|-0.82|1.32|||Mixed Models Analysis|||At Week 4||1.32|-0.82|0.642
72411122|NCT00403546|144330592|SUPERIORITY||Mean Difference (Net)|-0.34||||0.57|TWO_SIDED|95.0|-1.5|0.83|||Mixed Models Analysis|||At Week 6||0.83|-1.50|0.570
72411123|NCT00403546|144330592|SUPERIORITY||Mean Difference (Net)|-0.09||||0.894|TWO_SIDED|95.0|-1.34|1.17|||Mixed Models Analysis|||At Week 8||1.17|-1.34|0.894
72411124|NCT00403546|144330594|SUPERIORITY||Mean Difference (Net)|-1.82||||0.599|TWO_SIDED|95.0|-8.68|5.05|||Mixed Models Analysis|||SBP at Baseline||5.05|-8.68|0.599
72411125|NCT00403546|144330594|SUPERIORITY||Mean Difference (Net)|3.53||||0.235|TWO_SIDED|95.0|-2.31|9.37|||Mixed Models Analysis|||SBP at Week 1||9.37|-2.31|0.235
72411126|NCT00403546|144330594|SUPERIORITY||Mean Difference (Net)|2.83||||0.449|TWO_SIDED|95.0|-3.8|8.57|||Mixed Models Analysis|||SBP at Week 2||8.57|-3.80|0.449
72411127|NCT00403546|144330594|SUPERIORITY||Mean Difference (Net)|3.64||||0.301|TWO_SIDED|95.0|-3.28|10.56|||Mixed Models Analysis|||SBP at Week 4||10.56|-3.28|0.301
72578149|NCT00509795|144683830|SUPERIORITY_OR_OTHER||Differences in Least Squares means|-0.33||||0.3575|TWO_SIDED|95.1|-1.04|0.38||As adjustment of multiple comparisons, a conditional sequence of statistical hypotheses is used with alpha = 0.049|ANCOVA||The difference is calculated as IAI minus ranibizumab. A negative value favors IAI 2.0Q4|The pairwise comparison is performed as contrast statement in the analysis of covariance model with treatment group as fixed factor (all 4 treatment groups) and the baseline measure as covariate. The null hypothesis is that both mean changes are equal.||0.38|-1.04|0.3575
72411128|NCT00403546|144330594|SUPERIORITY||Mean Difference (Net)|-0.75||||0.842|TWO_SIDED|95.0|-8.13|6.63|||Mixed Models Analysis|||SBP at Week 6||6.63|-8.13|0.842
72411129|NCT00403546|144330594|SUPERIORITY||Mean Difference (Net)|6.33||||0.109|TWO_SIDED|95.0|-1.43|14.09|||Mixed Models Analysis|||SBP at Week 8||14.09|-1.43|0.109
72411130|NCT00403546|144330594|SUPERIORITY||Mean Difference (Net)|-0.8||||0.741|TWO_SIDED|95.0|-5.62|4.02|||Mixed Models Analysis|||DBP at Baseline||4.02|-5.62|0.741
72411131|NCT00403546|144330594|SUPERIORITY||Mean Difference (Net)|1.44||||0.552|TWO_SIDED|95.0|-3.32|6.19|||Mixed Models Analysis|||DBP at Week 1||6.19|-3.32|0.552
72411132|NCT00403546|144330594|SUPERIORITY||Mean Difference (Net)|2.83||||0.268|TWO_SIDED|95.0|-2.18|7.84|||Mixed Models Analysis|||DBP at Week 2||7.84|-2.18|0.268
72411133|NCT00403546|144330594|SUPERIORITY||Mean Difference (Net)|1.02||||0.719|TWO_SIDED|95.0|-4.53|6.56|||Mixed Models Analysis|||DBP at Week 4||6.56|-4.53|0.719
72411134|NCT00403546|144330594|SUPERIORITY||Mean Difference (Net)|-2.86||||0.334|TWO_SIDED|95.0|-8.68|2.96|||Mixed Models Analysis|||DBP at Week 6||2.96|-8.68|0.334
72411135|NCT00403546|144330594|SUPERIORITY||Mean Difference (Net)|4.38||||0.151|TWO_SIDED|95.0|-1.61|10.37|||Mixed Models Analysis|||DBP at Week 8||10.37|-1.61|0.151
72411136|NCT00403546|144330596|SUPERIORITY||Mean Difference (Final Values)|2.77||||0.416|TWO_SIDED|95.0|-3.97|9.5|||Mixed Models Analysis|Mixed models analysis with random slopes||At Baseline||9.50|-3.97|0.416
72411137|NCT00403546|144330596|SUPERIORITY||Mean Difference (Net)|0.37||||0.854|TWO_SIDED|95.0|-3.59|4.33|||Mixed Models Analysis|||At Week 2||4.33|-3.59|0.854
72329468|NCT03037476|144184387|OTHER|General Linear Model|Slope|-0.0128||||0.868|TWO_SIDED|95.0|-0.1633|0.1378|||Mixed Models Analysis|Negative Binomial Regression||Change in RAPI count at 6 month follow-up||0.1378|-0.1633|0.868
72411138|NCT00403546|144330596|SUPERIORITY||Mean Difference (Net)|1.95||||0.406|TWO_SIDED|95.0|-2.68|6.58|||Mixed Models Analysis|||At Week 4||6.58|-2.68|0.406
72411139|NCT00403546|144330596|SUPERIORITY||Mean Difference (Net)|-3.01||||0.256|TWO_SIDED|95.0|-8.23|2.21|||Mixed Models Analysis|||At Week 6||2.21|-8.23|0.256
72411140|NCT00403546|144330596|SUPERIORITY||Mean Difference (Net)|-1.37||||0.642|TWO_SIDED|95.0|-7.2|4.45|||Mixed Models Analysis|||At Week 8||4.45|-7.20|0.642
72411141|NCT00403546|144330598|SUPERIORITY||Mean Difference (Final Values)|-0.67||||0.135|TWO_SIDED|95.0|-1.55|0.2|||Mixed Models Analysis|||At Baseline||0.20|-1.55|0.135
72411142|NCT00403546|144330598|SUPERIORITY||Mean Difference (Net)|0.44||||0.262|TWO_SIDED|95.0|-0.33|1.21|||Mixed Models Analysis|||At Week 2||1.21|-0.33|0.262
72411143|NCT00403546|144330598|SUPERIORITY||Mean Difference (Net)|0.58||||0.209|TWO_SIDED|95.0|-0.33|1.49|||Mixed Models Analysis|||At Week 4||1.49|-0.33|0.209
72411144|NCT00403546|144330598|SUPERIORITY||Mean Difference (Net)|0.03||||0.95|TWO_SIDED|95.0|-1.01|1.07|||Mixed Models Analysis|||At Week 6||1.07|-1.01|0.950
72411145|NCT00403546|144330598|SUPERIORITY||Mean Difference (Net)|0.57||||0.34|TWO_SIDED|95.0|-0.61|1.76|||Mixed Models Analysis|||At Week 8||1.76|-0.61|0.340
72411146|NCT02673697|144330607|NON_INFERIORITY|"The primary analysis will calculate the Bayesian posterior probability that the difference \[MACCECONTROL~\- MACCEPERCEVAL\] is lower than 0.05 (predetermined non-inferiority margin): The null hypothesis will be rejected, and non-inferiority concluded, if the posterior probability exceeds 0.9775 at the final analysis."||||||0.9914||||||The null hypothesis will be rejected, and non-inferiority concluded, if the posterior probability exceeds 0.9775 at the final analysis.|Bayesian|||"A the primary analysis will compare Perceval valve (Treatment arm) vs. standard sutured stented valve (Control arm) on the Per Protocol population.~A one-sided non-inferiority test, using the non-inferiority margin Δ=0.05, will be performed to compare the two arms on the proportion of subjects that are event-free at one year (primary analysis)."||||0.9914
72411147|NCT03893448|144330619|OTHER||Percentage Point Difference|-4.8|||=|0.039|TWO_SIDED|95.0|-9.3|-0.2|||Miettinen & Nurminen||V114-Prevnar 13™|Injection site erythema Estimated difference, CI, and p-value are calculated based on the Miettinen \& Nurminen method||-0.2|-9.3|= 0.039
72411148|NCT03893448|144330619|OTHER||Percentage Point Difference|-0.4|||=|0.836|TWO_SIDED|95.0|-4.6|3.7|||Miettinen & Nurminen||V114-Prevnar 13™|Injection site induration Estimated difference, CI, and p-value are calculated based on the Miettinen \& Nurminen method||3.7|-4.6|= 0.836
72411149|NCT03893448|144330619|OTHER||Percentage Point Difference|2.9|||=|0.235|TWO_SIDED|95.0|-1.9|7.6|||Miettinen & Nurminen||V114-Prevnar 13™|Injection site pain Estimated difference, CI, and p-value are calculated based on the Miettinen \& Nurminen method||7.6|-1.9|= 0.235
72411150|NCT03893448|144330619|OTHER||Percentage Point Difference|2.4|||=|0.26|TWO_SIDED|95.0|-1.7|6.5|||Miettinen & Nurminen||V114-Prevnar 13™|Injection site swelling Estimated difference, CI, and p-value are calculated based on the Miettinen \& Nurminen method||6.5|-1.7|= 0.260
72411151|NCT03893448|144330620|OTHER||Percentage Point Difference|-1.8|||=|0.446|TWO_SIDED|95.0|-6.3|2.8|||Miettinen & Nurminen||V114-Prevnar 13™|Decreased appetite Estimated difference, CI, and p-value are calculated based on the Miettinen \& Nurminen method||2.8|-6.3|= 0.446
72411152|NCT03893448|144330620|OTHER||Percentage Point Difference|1.0|||=|0.622|TWO_SIDED|95.0|-3.0|5.1|||Miettinen & Nurminen||V114-Prevnar 13™|Irritability Estimated difference, CI, and p-value are calculated based on the Miettinen \& Nurminen method||5.1|-3.0|= 0.622
72411153|NCT03893448|144330620|OTHER||Percentage Point Difference|-3.0|||=|0.202|TWO_SIDED|95.0|-7.6|1.6|||Miettinen & Nurminen||V114-Prevnar 13™|Somnolence (drowsiness) Estimated difference, CI, and p-value are calculated based on the Miettinen \& Nurminen method||1.6|-7.6|= 0.202
72411154|NCT03893448|144330620|OTHER||Percentage Point Difference|0.0|||=|0.985|TWO_SIDED|95.0|-2.4|2.3|||Miettinen & Nurminen||V114-Prevnar 13™|Urticaria (Hives) Estimated difference, CI, and p-value are calculated based on the Miettinen \& Nurminen method||2.3|-2.4|= 0.985
72411155|NCT03893448|144330621|OTHER||Percentage Point Difference|0.0|||||TWO_SIDED|95.0|-0.4|0.4|||||V114-Prevnar 13™|Estimated difference, CI, and p-value are calculated based on the Miettinen \& Nurminen method||0.4|-0.4|
72411156|NCT03893448|144330622|NON_INFERIORITY|A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevnar 13™) being \>-10 percentage points (1-sided p-value \<0.025).|Percentage Point Difference|-3.4|||<|0.001|TWO_SIDED|95.0|-5.2|-1.8||p-value is 1-sided|Miettinen & Nurminen||V114-Prevnar 13™|Serotype 1 Estimated difference, CI, and p-value are calculated based on the Miettinen \& Nurminen method||-1.8|-5.2|< 0.001
72411157|NCT03893448|144330622|NON_INFERIORITY|A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevnar 13™) being \>-10 percentage points (1-sided p-value \<0.025).|Percentage Point Difference|15.6|||<|0.001|TWO_SIDED|95.0|12.1|19.2||p-value is 1-sided|Miettinen & Nurminen||V114-Prevnar 13™|Serotype 3 Estimated difference, CI, and p-value are calculated based on the Miettinen \& Nurminen method||19.2|12.1|< 0.001
72411158|NCT03893448|144330622|NON_INFERIORITY|A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevnar 13™) being \>-10 percentage points (1-sided p-value \<0.025).|Percentage Point Difference|-2.2|||<|0.001|TWO_SIDED|95.0|-4.0|-0.6||p-value is 1-sided|Miettinen & Nurminen||V114-Prevnar 13™|Serotype 4 Estimated difference, CI, and p-value are calculated based on the Miettinen \& Nurminen method||-0.6|-4.0|< 0.001
72411159|NCT03893448|144330622|NON_INFERIORITY|A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevnar 13™) being \>-10 percentage points (1-sided p-value \<0.025).|Percentage Point Difference|-2.1|||<|0.001|TWO_SIDED|95.0|-4.2|-0.2||p-value is 1-sided|Miettinen & Nurminen||V114-Prevnar 13™|Serotype 5 Estimated difference, CI, and p-value are calculated based on the Miettinen \& Nurminen method||-0.2|-4.2|< 0.001
72411160|NCT03893448|144330622|NON_INFERIORITY|A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevnar 13™) being \>-10 percentage points (1-sided p-value \<0.025).|Percentage Point Difference|-4.9|||<|0.001|TWO_SIDED|95.0|-7.1|-3.0||p-value is 1-sided|Miettinen & Nurminen||V114-Prevnar 13™|Serotype 6A Estimated difference, CI, and p-value are calculated based on the Miettinen \& Nurminen method||-3.0|-7.1|< 0.001
72411161|NCT03893448|144330622|NON_INFERIORITY|A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevnar 13™) being \>-10 percentage points (1-sided p-value \<0.025).|Percentage Point Difference|-3.4|||<|0.001|TWO_SIDED|95.0|-6.6|-0.3||p-value is 1-sided|Miettinen & Nurminen||V114-Prevnar 13™|Serotype 6B Estimated difference, CI, and p-value are calculated based on the Miettinen \& Nurminen method||-0.3|-6.6|< 0.001
72411162|NCT03893448|144330622|NON_INFERIORITY|A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevnar 13™) being \>-10 percentage points (1-sided p-value \<0.025).|Percentage Point Difference|-0.8|||<|0.001|TWO_SIDED|95.0|-1.9|-0.1||p-value is 1-sided|Miettinen & Nurminen||V114-Prevnar 13™|Serotype 7F Estimated difference, CI, and p-value are calculated based on the Miettinen \& Nurminen method||-0.1|-1.9|< 0.001
72411163|NCT03893448|144330622|NON_INFERIORITY|A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevnar 13™) being \>-10 percentage points (1-sided p-value \<0.025).|Percentage Point Difference|-1.0|||<|0.001|TWO_SIDED|95.0|-2.8|0.6||p-value is 1-sided|Miettinen & Nurminen||V114-Prevnar 13™|Serotype 9V Estimated difference, CI, and p-value are calculated based on the Miettinen \& Nurminen method||0.6|-2.8|< 0.001
72411164|NCT03893448|144330622|NON_INFERIORITY|A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevnar 13™) being \>-10 percentage points (1-sided p-value \<0.025).|Percentage Point Difference|0.0|||<|0.001|TWO_SIDED|95.0|-1.6|1.6||p-value is 1-sided|Miettinen & Nurminen||V114-Prevnar 13™|Serotype 14 Estimated difference, CI, and p-value are calculated based on the Miettinen \& Nurminen method||1.6|-1.6|< 0.001
72411165|NCT03893448|144330622|NON_INFERIORITY|A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevnar 13™) being \>-10 percentage points (1-sided p-value \<0.025).|Percentage Point Difference|-0.9|||<|0.001|TWO_SIDED|95.0|-2.6|0.7||p-value is 1-sided|Miettinen & Nurminen||V114-Prevnar 13™|Serotype 18C Estimated difference, CI, and p-value are calculated based on the Miettinen \& Nurminen method||0.7|-2.6|< 0.001
72543496|NCT00219557|144616974|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.49|||||TWO_SIDED|95.0|-7.45|34.42||||||For change in eating related items at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.||34.42|-7.45|
72543497|NCT00219557|144616974|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|18.86|||||TWO_SIDED|95.0|0.17|37.55||||||For change in altered bowel habits at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.||37.55|0.17|
72543498|NCT00219557|144616974|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.57|||||TWO_SIDED|95.0|0.66|22.48||||||For change in jaundice at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.||22.48|0.66|
72543499|NCT00219557|144616974|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|18.72|||||TWO_SIDED|95.0|0.49|36.95||||||For change in body image at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.||36.95|0.49|
72543500|NCT00219557|144616974|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.61|||||TWO_SIDED|95.0|-32.4|11.17||||||For change in health care satisfaction at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.||11.17|-32.40|
72543501|NCT00219557|144616974|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.32|||||TWO_SIDED|95.0|-14.63|17.27||||||For change in sexual functioning at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.||17.27|-14.63|
72543502|NCT00219557|144616974|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.54|||||TWO_SIDED|95.0|-14.7|17.78||||||For change in ascites at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.||17.78|-14.70|
72543503|NCT00219557|144616974|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.05|||||TWO_SIDED|95.0|-10.65|32.75||||||For change in indigestion at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.||32.75|-10.65|
72543504|NCT00219557|144616974|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.4|||||TWO_SIDED|95.0|-17.33|24.13||||||For change in flatulence at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.||24.13|-17.33|
72543505|NCT00219557|144616974|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.27|||||TWO_SIDED|95.0|-4.4|22.93||||||For change in cachexia at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.||22.93|-4.40|
72543506|NCT00219557|144616974|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|19.19|||||TWO_SIDED|95.0|2.99|35.39||||||For change in side effects at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.||35.39|2.99|
72543507|NCT00219557|144616974|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.63|||||TWO_SIDED|95.0|-23.7|22.43||||||For change in fear of future health at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.||22.43|-23.70|
72543508|NCT00219557|144616974|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|21.51|||||TWO_SIDED|95.0|-3.1|46.12||||||For change in ability to plan future at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.||46.12|-3.10|
72543509|NCT00219557|144616974|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.19|||||TWO_SIDED|95.0|-21.57|13.19||||||For change in pancreatic pain at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.||13.19|-21.57|
72543510|NCT00219557|144616974|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.6|||||TWO_SIDED|95.0|-32.86|7.66||||||For change in eating related items at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.||7.66|-32.86|
72543511|NCT00219557|144616974|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.25|||||TWO_SIDED|95.0|-10.33|34.82||||||For change in altered bowel habits at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.||34.82|-10.33|
72543512|NCT00219557|144616974|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.84|||||TWO_SIDED|95.0|-0.18|25.85||||||For change in jaundice at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.||25.85|-0.18|
72543513|NCT00219557|144616974|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.85|||||TWO_SIDED|95.0|-16.45|24.14||||||For change in body image at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.||24.14|-16.45|
72578150|NCT00509795|144683830|SUPERIORITY_OR_OTHER||Differences in Least Squares means|0.71||||0.0507|TWO_SIDED|95.1|-0.01|1.42||As adjustment of multiple comparisons, a conditional sequence of statistical hypotheses is used with alpha = 0.049|ANCOVA||The difference is calculated as IAI minus ranibizumab. A negative value favors IAI 0.5Q4|The pairwise comparison is performed as contrast statement in the analysis of covariance model with treatment group as fixed factor (all 4 treatment groups) and the baseline measure as covariate. The null hypothesis is that both mean changes are equal.||1.42|-0.01|0.0507
72578151|NCT00509795|144683830|SUPERIORITY_OR_OTHER||Differences in Least Squares means|0.86||||0.0173|TWO_SIDED|95.1|0.15|1.58||As adjustment of multiple comparisons, a conditional sequence of statistical hypotheses is used with alpha = 0.049|ANCOVA||The difference is calculated as IAI minus ranibizumab. A negative value favors IAI 2.0Q8|The pairwise comparison is performed as contrast statement in the analysis of covariance model with treatment group as fixed factor (all 4 treatment groups) and the baseline measure as covariate. The null hypothesis is that both mean changes are equal.||1.58|0.15|0.0173
72411166|NCT03893448|144330622|NON_INFERIORITY|A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevnar 13™) being \>-10 percentage points (1-sided p-value \<0.025).|Percentage Point Difference|-1.8|||<|0.001|TWO_SIDED|95.0|-3.2|-0.8||p-value is 1-sided|Miettinen & Nurminen||V114-Prevnar 13™|Serotype 19A Estimated difference, CI, and p-value are calculated based on the Miettinen \& Nurminen method||-0.8|-3.2|< 0.001
72578152|NCT04102189|144683831|SUPERIORITY||Treatment difference|-16.75|||<|0.0001|TWO_SIDED|95.0|-20.27|-13.23|||ANCOVA|||Responses were analyzed using an analysis of covariance model with randomized treatment, stratification groups (sex and Tanner stage at baseline) and the interaction between stratification groups as factors and baseline BMI as covariate.||-13.23|-20.27|<.0001
72578153|NCT02933255|144683872|OTHER||||||<|0.0001||||||The reported p-value is representative of changes in CD8+T cell infiltration within the total tissue at time of prostatectomy compared to baseline.|Wilcoxon Signed Rank Test|||||||<0.0001
72578154|NCT02933255|144683872|OTHER|||||||0.04||||||The reported p-value is representative of changes in CD8+T cell infiltration in the center of the tumor at time of prostatectomy compared to baseline.|Wilcoxon Signed Rank Test|||||||0.04
72578155|NCT02933255|144683872|OTHER|||||||0.002||||||The reported p-value is representative of changes in CD8+T cell infiltration in the invasive margin at time of prostatectomy compared to baseline.|Wilcoxon Signed Rank Test|||||||0.002
72578156|NCT02933255|144683872|OTHER|||||||0.46||||||The reported p-value is representative of changes in CD8+T cell infiltration in the normal region at time of prostatectomy compared to baseline.|Wilcoxon Signed Rank Test|||||||0.46
72578157|NCT02933255|144683872|OTHER||||||<|0.0001||||||The reported p-value is representative of changes in CD4 T cell helper infiltration in the total tissue at time of prostatectomy compared to baseline.|Wilcoxon Signed Rank Test|||||||<0.0001
72578158|NCT02933255|144683872|OTHER|||||||0.016||||||The reported p-value is representative of changes in CD4 T cell helper infiltration in the center of the tumor at time of prostatectomy compared to baseline.|Wilcoxon Signed Rank Test|||||||0.016
72578159|NCT02933255|144683872|OTHER|||||||0.002||||||The reported p-value is representative of changes in CD4 T cell helper infiltration in the invasive margin at time of prostatectomy compared to baseline.|Wilcoxon Signed Rank Test|||||||0.002
72578160|NCT02933255|144683872|OTHER|||||||0.38||||||The reported p-value is representative of changes in CD4 T cell helper infiltration in the normal region at time of prostatectomy compared to baseline.|Wilcoxon Signed Rank Test|||||||0.38
72578161|NCT02933255|144683874|OTHER|The reported p-value is representative of changes in soluble factors at 4 weeks of therapy compared to baseline in the lead-in metastatic castration-resistant prostate cancer (mCRPC) cohort.||||||0.064|||||||Wilcoxon Signed Rank Test|||||||0.064
72578162|NCT02933255|144683874|OTHER|The reported p-value is representative of changes in soluble factors at 4 weeks of therapy compared to baseline in the neoadjuvant cohort.||||||0.001|||||||Wilcoxon Signed Rank Test|||||||0.001
72578163|NCT02933255|144683874|OTHER|||||||0.003||||||The reported p-value is representative of changes in soluble factors at 10 weeks of therapy compared to baseline in the lead-in metastatic castration-resistant prostate cancer (mCRPC) cohort.|Wilcoxon Signed Rank Test|||||||0.003
72578164|NCT02933255|144683874|OTHER|||||||0.003||||||The reported p-value is representative of changes in soluble factors at 10 weeks of therapy compared to baseline in the neoadjuvant cohort.|Wilcoxon Signed Rank Test|||||||0.003
72578165|NCT02933255|144683874|OTHER|||||||0.004||||||The reported p-value is representative of changes in soluble factors at 20 weeks of therapy compared to baseline in the lead-in metastatic castration-resistant prostate cancer (mCRPC) cohort.|Wilcoxon Signed Rank Test|||||||0.004
72578166|NCT02933255|144683874|OTHER|||||||0.004||||||The reported p-value is representative of changes in soluble factors at 20 weeks of therapy compared to baseline in the neoadjuvant cohort.|Wilcoxon Signed Rank Test|||||||0.004
72329469|NCT03037476|144184387|OTHER|General Linear Model|Slope|-0.0445||||0.573|TWO_SIDED|95.0|-0.1993|0.1102|||Mixed Models Analysis|Negative Binomial Regression||Change in RAPI count at 12 month follow-up||0.1102|-0.1993|0.573
72578167|NCT02933255|144683875|OTHER|||||||0.002||||||The reported p-value is representative of changes in TNFα at 4 weeks of therapy compared to baseline in the lead-in metastatic castration-resistant prostate cancer (mCRPC) cohort.|Wilcoxon Signed Rank Test|||||||0.002
72578168|NCT02933255|144683875|OTHER|||||||0.042||||||The reported p-value is representative of changes in TNFα at 4 weeks of therapy compared to baseline in the neoadjuvant cohort.|Wilcoxon Signed Rank Test|||||||0.042
72578169|NCT02933255|144683875|OTHER|||||||0.233||||||The reported p-value is representative of changes in TNFα at 10 weeks of therapy compared to baseline in the lead-in metastatic castration-resistant prostate cancer (mCRPC) cohort.|Wilcoxon Signed Rank Test|||||||0.233
72578170|NCT02933255|144683875|OTHER|||||||0.052||||||The reported p-value is representative of changes in TNFα at 10 weeks of therapy compared to baseline in the neoadjuvant cohort.|Wilcoxon Signed Rank Test|||||||0.052
72578171|NCT02933255|144683875|OTHER|||||||0.055||||||The reported p-value is representative of changes in TNFα at 20 weeks of therapy compared to baseline in the lead-in metastatic castration-resistant prostate cancer (mCRPC) cohort.|Wilcoxon Signed Rank Test|||||||0.055
72578172|NCT02933255|144683875|OTHER|||||||0.203||||||The reported p-value is representative of changes in TNFα at 20 weeks of therapy compared to baseline in the neoadjuvant cohort.|Wilcoxon Signed Rank Test|||||||0.203
72578173|NCT02933255|144683875|OTHER||||||<|0.001||||||The reported p-value is representative of changes in IL-10 at 4 weeks of therapy compared to baseline in the lead-in metastatic castration-resistant prostate cancer (mCRPC) cohort.|Wilcoxon Signed Rank Test|||||||<0.001
72578174|NCT02933255|144683875|OTHER|||||||0.034||||||The reported p-value is representative of changes in IL-10 at 4 weeks of therapy compared to baseline in the neoadjuvant cohort.|Wilcoxon Signed Rank Test|||||||0.034
72578175|NCT02933255|144683875|OTHER||||||<|0.001||||||The reported p-value is representative of changes in IL-10 at 10 weeks of therapy compared to baseline in the lead-in metastatic castration-resistant prostate cancer (mCRPC) cohort.|Wilcoxon Signed Rank Test|||||||<0.001
72578176|NCT02933255|144683875|OTHER|||||||0.034||||||The reported p-value is representative of changes in IL-10 at 10 weeks of therapy compared to baseline in the neoadjuvant cohort.|Wilcoxon Signed Rank Test|||||||0.034
72578177|NCT02933255|144683875|OTHER|||||||0.004||||||The reported p-value is representative of changes in IL-10 at 20 weeks of therapy compared to baseline in the lead-in metastatic castration-resistant prostate cancer (mCRPC) cohort.|Wilcoxon Signed Rank Test|||||||0.004
72578178|NCT02933255|144683875|OTHER|||||||0.129||||||The reported p-value is representative of changes in IL-10 at 20 weeks of therapy compared to baseline in the neoadjuvant cohort.|Wilcoxon Signed Rank Test|||||||0.129
72578179|NCT02933255|144683877|OTHER|||||||0.339||||||The reported p-value is representative of changes in CD4+ T cells at week 4 post treatment compared to baseline in the lead-in metastatic castration-resistant prostate cancer cohort.|Wilcoxon Signed Rank Test|||||||0.339
72578180|NCT02933255|144683877|OTHER|||||||0.037||||||The reported p-value is representative of changes in CD4+ T cells at week 4 post treatment compared to baseline in the neoadjuvant cohort.|Wilcoxon Signed Rank Test|||||||0.037
72578181|NCT02933255|144683877|OTHER|||||||0.009||||||The reported p-value is representative of changes in CD4+ T cells at week 10 post treatment compared to baseline in the lead-in metastatic castration-resistant prostate cancer cohort.|Wilcoxon Signed Rank Test|||||||0.009
72578182|NCT02933255|144683877|OTHER|||||||0.844||||||The reported p-value is representative of changes in CD4+ T cells at week 10 post treatment compared to baseline in the neoadjuvant cohort.|Wilcoxon Signed Rank Test|||||||0.844
72543514|NCT00219557|144616974|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.05|||||TWO_SIDED|95.0|-23.23|37.34||||||For change in health care satisfaction at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.||37.34|-23.23|
72543515|NCT00219557|144616974|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.53|||||TWO_SIDED|95.0|-26.55|21.5||||||For change in sexual functioning at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.||21.50|-26.55|
72543516|NCT00219557|144616974|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.46|||||TWO_SIDED|95.0|-27.48|8.56||||||For change in ascites at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.||8.56|-27.48|
72543517|NCT00219557|144616974|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.96|||||TWO_SIDED|95.0|-30.62|16.7||||||For change in indigestion at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.||16.70|-30.62|
72543518|NCT00219557|144616974|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.71|||||TWO_SIDED|95.0|-20.37|27.8||||||For change in flatulence at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.||27.80|-20.37|
72543519|NCT00219557|144616974|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.04|||||TWO_SIDED|95.0|-5.73|31.81||||||For change in cachexia at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.||31.81|-5.73|
72543520|NCT00219557|144616974|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|15.12|||||TWO_SIDED|95.0|-3.23|33.46||||||For change in side effects at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.||33.46|-3.23|
72543521|NCT00219557|144616974|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.91|||||TWO_SIDED|95.0|-36.18|20.37||||||For change in fear of future health at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.||20.37|-36.18|
72543522|NCT00219557|144616974|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|15.38|||||TWO_SIDED|95.0|-20.24|51.01||||||For change in ability to plan future at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.||51.01|-20.24|
72543523|NCT00219557|144616974|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.25|||||TWO_SIDED|95.0|-10.09|32.59||||||For change in pancreatic pain at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.||32.59|-10.09|
72543524|NCT00219557|144616974|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.41|||||TWO_SIDED|95.0|-25.22|40.03||||||For change in eating related items at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.||40.03|-25.22|
72543525|NCT00219557|144616974|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|28.28|||||TWO_SIDED|95.0|4.23|52.32||||||For change in altered bowel habits at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.||52.32|4.23|
72543526|NCT00219557|144616974|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|24.22|||||TWO_SIDED|95.0|5.09|43.34||||||For change in jaundice at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.||43.34|5.09|
72543527|NCT00219557|144616974|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|25.11|||||TWO_SIDED|95.0|-0.16|50.38||||||For change in body image at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.||50.38|-0.16|
72543528|NCT00219557|144616974|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.07|||||TWO_SIDED|95.0|-47.95|27.8||||||For change in health care satisfaction at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.||27.80|-47.95|
72543529|NCT00219557|144616974|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.61|||||TWO_SIDED|95.0|-21.78|14.57||||||For change in sexual functioning at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.||14.57|-21.78|
72543530|NCT00219557|144616974|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.98|||||TWO_SIDED|95.0|-17.02|28.99||||||For change in ascites at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.||28.99|-17.02|
72543531|NCT00219557|144616974|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|22.08|||||TWO_SIDED|95.0|-5.39|49.55||||||For change in indigestion at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.||49.55|-5.39|
72543532|NCT00219557|144616974|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.78|||||TWO_SIDED|95.0|-15.33|34.89||||||For change in flatulence at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.||34.89|-15.33|
72543533|NCT00219557|144616974|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|15.81|||||TWO_SIDED|95.0|-10.43|42.06||||||For change in cachexia at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.||42.06|-10.43|
72543534|NCT00219557|144616974|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|21.77|||||TWO_SIDED|95.0|1.11|42.43||||||For change in side effects at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.||42.43|1.11|
72543535|NCT00219557|144616974|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.81|||||TWO_SIDED|95.0|-41.91|12.28||||||For change in fear of future health at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.||12.28|-41.91|
72543536|NCT00219557|144616974|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|31.11|||||TWO_SIDED|95.0|1.6|60.62||||||For change in ability to plan future at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.||60.62|1.60|
72543537|NCT00219557|144616974|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.74|||||TWO_SIDED|95.0|-20.62|38.1||||||For change in pancreatic pain at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.||38.10|-20.62|
72543538|NCT00219557|144616974|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.24|||||TWO_SIDED|95.0|-68.52|42.05||||||For change in eating related items at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.||42.05|-68.52|
72543539|NCT00219557|144616974|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|22.06|||||TWO_SIDED|95.0|-7.93|52.05||||||For change in altered bowel habits at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.||52.05|-7.93|
72543540|NCT00219557|144616974|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|18.63|||||TWO_SIDED|95.0|-5.64|42.89||||||For change in jaundice at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.||42.89|-5.64|
72543541|NCT00219557|144616974|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|23.96|||||TWO_SIDED|95.0|-9.93|57.84||||||For change in body image at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.||57.84|-9.93|
72543542|NCT00219557|144616974|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.54|||||TWO_SIDED|95.0|-32.7|59.78||||||For change in health care satisfaction at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.||59.78|-32.70|
72543543|NCT00219557|144616974|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.14|||||TWO_SIDED|95.0|-29.46|55.74||||||For change in sexual functioning at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.||55.74|-29.46|
72543544|NCT00219557|144616974|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.37|||||TWO_SIDED|95.0|-24.04|36.79||||||For change in ascites at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.||36.79|-24.04|
72543545|NCT00219557|144616974|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|20.59|||||TWO_SIDED|95.0|-17.94|59.12||||||For change in indigestion at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.||59.12|-17.94|
72411167|NCT03893448|144330622|NON_INFERIORITY|A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevnar 13™) being \>-10 percentage points (1-sided p-value \<0.025).|Percentage Point Difference|-1.0|||<|0.001|TWO_SIDED|95.0|-2.1|-0.4||p-value is 1-sided|Miettinen & Nurminen||V114-Prevnar 13™|Serotype 19F Estimated difference, CI, and p-value are calculated based on the Miettinen \& Nurminen method||-0.4|-2.1|< 0.001
72411168|NCT03893448|144330622|NON_INFERIORITY|A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevnar 13™) being \>-10 percentage points (1-sided p-value \<0.025).|Percentage Point Difference|-0.3|||<|0.001|TWO_SIDED|95.0|-3.2|2.7||p-value is 1-sided|Miettinen & Nurminen||V114-Prevnar 13™|Serotype 23F Estimated difference, CI, and p-value are calculated based on the Miettinen \& Nurminen method||2.7|-3.2|< 0.001
72578183|NCT02933255|144683877|OTHER|||||||0.204||||||The reported p-value is representative of changes in CD8+ T cells at week 4 post treatment compared to baseline in the lead-in metastatic castration-resistant prostate cancer cohort.|Wilcoxon Signed Rank Test|||||||0.204
72578184|NCT02933255|144683877|OTHER|||||||0.084||||||The reported p-value is representative of changes in CD8+ T cells at week 4 post treatment compared to baseline in the neoadjuvant cohort.|Wilcoxon Signed Rank Test|||||||0.084
72578185|NCT02933255|144683877|OTHER|||||||0.042||||||The reported p-value is representative of changes in CD8+ T cells at week 10 post treatment compared to baseline in the lead-in metastatic castration-resistant prostate cancer cohort.|Wilcoxon Signed Rank Test|||||||0.042
72578186|NCT02933255|144683877|OTHER|||||||0.688||||||The reported p-value is representative of changes in CD8+ T cells at week 10 post treatment compared to baseline in the neoadjuvant cohort.|Wilcoxon Signed Rank Test|||||||0.688
72578187|NCT02933255|144683877|OTHER||||||<|0.001||||||The reported p-value is representative of changes in Treg cells at week 4 post treatment compared to baseline in the lead-in metastatic castration-resistant prostate cancer cohort.|Wilcoxon Signed Rank Test|||||||<0.001
72578188|NCT02933255|144683877|OTHER|||||||0.733||||||The reported p-value is representative of changes in Treg cells at week 4 post treatment compared to baseline in the neoadjuvant cohort.|Wilcoxon Signed Rank Test|||||||0.733
72578189|NCT02933255|144683877|OTHER|||||||0.519||||||The reported p-value is representative of changes in Treg cells at week 10 post treatment compared to baseline in the lead-in metastatic castration-resistant prostate cancer cohort.|Wilcoxon Signed Rank Test|||||||0.519
72578190|NCT02933255|144683877|OTHER|||||||0.695||||||The reported p-value is representative of changes in Treg cells at week 10 post treatment compared to baseline in the neoadjuvant cohort.|Wilcoxon Signed Rank Test|||||||0.695
72578191|NCT02933255|144683877|OTHER|||||||0.034||||||The reported p-value is representative of changes in cDC cells at week 4 post treatment compared to baseline in the lead-in metastatic castration-resistant prostate cancer cohort.|Wilcoxon Signed Rank Test|||||||0.034
72578192|NCT02933255|144683877|OTHER|||||||0.301||||||The reported p-value is representative of changes in cDC cells at week 4 post treatment compared to baseline in the neoadjuvant cohort.|Wilcoxon Signed Rank Test|||||||0.301
72578193|NCT02933255|144683877|OTHER|||||||0.38||||||The reported p-value is representative of changes in cDC cells at week 10 post treatment compared to baseline in the lead-in metastatic castration-resistant prostate cancer cohort.|Wilcoxon Signed Rank Test|||||||0.38
72578194|NCT02933255|144683877|OTHER|||||||0.014||||||The reported p-value is representative of changes in cDC cells at week 10 post treatment compared to baseline in the neoadjuvant cohort.|Wilcoxon Signed Rank Test|||||||0.014
72578195|NCT02933255|144683877|OTHER|||||||0.791||||||The reported p-value is representative of changes in monocytes at week 4 post treatment compared to baseline in the lead-in metastatic castration-resistant prostate cancer cohort.|Wilcoxon Signed Rank Test|||||||0.791
72578196|NCT02933255|144683877|OTHER|||||||0.042||||||The reported p-value is representative of changes in monocytes at week 4 post treatment compared to baseline in the neoadjuvant cohort.|Wilcoxon Signed Rank Test|||||||0.042
72578197|NCT02933255|144683877|OTHER|||||||0.424||||||The reported p-value is representative of changes in monocytes at week 10 post treatment compared to baseline in the lead-in metastatic castration-resistant prostate cancer cohort.|Wilcoxon Signed Rank Test|||||||0.424
72578198|NCT02933255|144683877|OTHER|||||||0.77||||||The reported p-value is representative of changes in monocytes at week 10 post treatment compared to baseline in the lead-in neoadjuvant cohort.|Wilcoxon Signed Rank Test|||||||0.77
72411169|NCT03893448|144330622|NON_INFERIORITY|A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevnar 13™) being \>-10 percentage points (1-sided p-value \<0.025).|Percentage Point Difference|6.7|||<|0.001|TWO_SIDED|95.0|4.6|9.2||p-value is 1-sided|Miettinen & Nurminen||V114-Prevnar 13™|Serotype 22F This analysis represents the difference between response rate to Serotype 22F in recipients of V114 and lowest response (Serotype 23F at 91.8) in recipients of Prevnar 13™ for shared serotypes, excluding serotype 3. Estimated difference, CI, and p-value are calculated based on the Miettinen \& Nurminen method||9.2|4.6|< 0.001
72543546|NCT00219557|144616974|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.29|||||TWO_SIDED|95.0|-20.12|40.71||||||For change in flatulence at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.||40.71|-20.12|
72543547|NCT00219557|144616974|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|25.74|||||TWO_SIDED|95.0|-8.22|59.69||||||For change in cachexia at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.||59.69|-8.22|
72543548|NCT00219557|144616974|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|38.56|||||TWO_SIDED|95.0|5.32|71.81||||||For change in side effects at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.||71.81|5.32|
72543549|NCT00219557|144616974|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.44|||||TWO_SIDED|95.0|-53.14|44.25||||||For change in fear of future health at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.||44.25|-53.14|
72543550|NCT00219557|144616974|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.17|||||TWO_SIDED|95.0|-69.9|61.57||||||For change in ability to plan future at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.||61.57|-69.90|
72543551|NCT00219557|144616974|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.96|||||TWO_SIDED|95.0|-24.52|50.45||||||For change in pancreatic pain at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.||50.45|-24.52|
72543552|NCT00219557|144616974|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-23.15|||||TWO_SIDED|95.0|-76.41|30.11||||||For change in eating related items at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.||30.11|-76.41|
72543553|NCT00219557|144616974|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.44|||||TWO_SIDED|95.0|-71.89|33.0||||||For change in altered bowel habits at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.||33.00|-71.89|
72543554|NCT00219557|144616974|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|47.22|||||TWO_SIDED|95.0|7.31|87.13||||||For change in jaundice at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.||87.13|7.31|
72543555|NCT00219557|144616974|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|41.67|||||TWO_SIDED|95.0|-36.0|119.34||||||For change in body image at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.||119.34|-36.00|
72543556|NCT00219557|144616974|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|38.89|||||TWO_SIDED|95.0|-5.05|82.83||||||For change in health care satisfaction at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.||82.83|-5.05|
72543557|NCT00219557|144616974|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|32.14|||||TWO_SIDED|95.0|-2.09|66.37||||||For change in sexual functioning at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.||66.37|-2.09|
72543558|NCT00219557|144616974|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.41|||||TWO_SIDED|95.0|-44.46|29.64||||||For change in indigestion at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.||29.64|-44.46|
72543559|NCT00219557|144616974|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.96|||||TWO_SIDED|95.0|-40.45|66.37||||||For change in flatulence at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.||66.37|-40.45|
72543560|NCT00219557|144616974|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.89|||||TWO_SIDED|95.0|-32.71|60.49||||||For change in cachexia at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.||60.49|-32.71|
72543561|NCT00219557|144616974|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|30.86|||||TWO_SIDED|95.0|-16.16|77.89||||||For change in side effects at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.||77.89|-16.16|
72543562|NCT00219557|144616974|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|20.83|||||TWO_SIDED|95.0|-44.95|86.62||||||For change in fear of future health at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.||86.62|-44.95|
72543563|NCT00219557|144616974|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-18.52|||||TWO_SIDED|95.0|-115.22|78.19||||||For change in ability to plan future at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.||78.19|-115.22|
72543564|NCT00219557|144616974|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|23.46|||||TWO_SIDED|95.0|-39.71|86.63||||||For change in pancreatic pain at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.||86.63|-39.71|
72543565|NCT00219557|144616974|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.96|||||TWO_SIDED|95.0|-130.69|104.76||||||For change in eating related items at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.||104.76|-130.69|
72543566|NCT00219557|144616974|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|48.15|||||TWO_SIDED|95.0|-7.12|103.42||||||For change in altered bowel habits at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.||103.42|-7.12|
72543567|NCT00219557|144616974|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|92.59|||||TWO_SIDED|95.0|63.16|122.02||||||For change in jaundice at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.||122.02|63.16|
72543568|NCT00219557|144616974|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.56|||||TWO_SIDED|95.0|-85.03|96.14||||||For change in body image at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.||96.14|-85.03|
72543569|NCT00219557|144616974|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|37.04|||||TWO_SIDED|95.0|-29.46|103.54||||||For change in health care satisfaction at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.||103.54|-29.46|
72543570|NCT00219557|144616974|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.14|||||TWO_SIDED|95.0|-41.45|27.16||||||For change in sexual functioning at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.||27.16|-41.45|
72543571|NCT00219557|144616974|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.7|||||TWO_SIDED|95.0|-67.04|59.64||||||For change in ascites at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.||59.64|-67.04|
72543572|NCT00219557|144616974|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.41|||||TWO_SIDED|95.0|-104.79|89.97||||||For change in indigestion at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.||89.97|-104.79|
72543573|NCT00219557|144616974|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|22.22|||||TWO_SIDED|95.0|-58.8|103.25||||||For change in flatulence at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.||103.25|-58.80|
72543574|NCT00219557|144616974|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|27.78|||||TWO_SIDED|95.0|-36.28|91.83||||||For change in cachexia at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.||91.83|-36.28|
72543575|NCT00219557|144616974|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.11|||||TWO_SIDED|95.0|-74.3|96.52||||||For change in side effects at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.||96.52|-74.30|
72411170|NCT03893448|144330622|NON_INFERIORITY|A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevnar 13™) being \>-10 percentage points (1-sided p-value \<0.025).|Percentage Point Difference|-4.5|||<|0.001|TWO_SIDED|95.0|-7.8|-1.3||p-value is 1-sided|Miettinen & Nurminen||V114-Prevnar 13™|Serotype 33F This analysis represents the difference between response rate to Serotype 33F in recipients of V114 and lowest response (Serotype 23F at 91.8) in recipients of Prevnar 13™ for shared serotypes, excluding serotype 3. Estimated difference, CI, and p-value are calculated based on the Miettinen \& Nurminen method||-1.3|-7.8|< 0.001
72411171|NCT03893448|144330623|NON_INFERIORITY|A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevnar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio (V114 / Prevnar 13™)|0.64|||<|0.001|TWO_SIDED|95.0|0.59|0.69|||t-test, 1 sided||V114/Prevnar 13™|Serotype 1 GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||0.69|0.59|< 0.001
72411172|NCT03893448|144330623|NON_INFERIORITY|A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevnar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio (V114 / Prevnar 13™)|1.73|||<|0.001|TWO_SIDED|95.0|1.61|1.87|||t-test, 1 sided||V114/Prevnar 13™|Serotype 3 GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||1.87|1.61|< 0.001
72411173|NCT03893448|144330623|NON_INFERIORITY|A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevnar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio (V114 / Prevnar 13™)|0.95|||<|0.001|TWO_SIDED|95.0|0.88|1.03|||t-test, 1 sided||V114/Prevnar 13™|Serotype 4 GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||1.03|0.88|< 0.001
72411174|NCT03893448|144330623|NON_INFERIORITY|A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevnar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio (V114 / Prevnar 13™)|0.72|||<|0.001|TWO_SIDED|95.0|0.66|0.8|||t-test, 1 sided||V114/Prevnar 13™|Serotype 5 GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||0.80|0.66|< 0.001
72411175|NCT03893448|144330623|NON_INFERIORITY|A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevnar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio (V114 / Prevnar 13™)|0.52|||=|0.167|TWO_SIDED|95.0|0.48|0.58|||t-test, 1 sided||V114/Prevnar 13™|Serotype 6A GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||0.58|0.48|= 0.167
72411176|NCT03893448|144330623|NON_INFERIORITY|A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevnar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio (V114 / Prevnar 13™)|0.81|||<|0.001|TWO_SIDED|95.0|0.71|0.93|||t-test, 1 sided||V114/Prevnar 13™|Serotype 6B GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||0.93|0.71|< 0.001
72411177|NCT03893448|144330623|NON_INFERIORITY|A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevnar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio (V114 / Prevnar 13™)|0.77|||<|0.001|TWO_SIDED|95.0|0.71|0.83|||t-test, 1 sided||V114/Prevnar 13™|Serotype 7F GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||0.83|0.71|< 0.001
72543576|NCT00219557|144616974|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-29.17|||||TWO_SIDED|95.0|-142.55|84.21||||||For change in fear of future health at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.||84.21|-142.55|
72578199|NCT02933255|144683877|OTHER|||||||0.001||||||The reported p-value is representative of changes in CD4+ki67+ T cells at week 4 post treatment compared to baseline in the lead-in metastatic castration-resistant prostate cancer cohort.|Wilcoxon Signed Rank Test|||||||0.001
72578200|NCT02933255|144683877|OTHER|||||||0.105||||||The reported p-value is representative of changes in CD4+ki67+ T cells at week 4 post treatment compared to baseline in the neoadjuvant cohort.|Wilcoxon Signed Rank Test|||||||0.105
72578201|NCT02933255|144683877|OTHER|||||||0.622||||||The reported p-value is representative of changes in CD4+ki67+ T cells at week 10 post treatment compared to baseline in the lead-in metastatic castration-resistant prostate cancer cohort.|Wilcoxon Signed Rank Test|||||||0.622
72578202|NCT02933255|144683877|OTHER|||||||0.313||||||The reported p-value is representative of changes in CD4+ki67+ T cells at week 10 post treatment compared to baseline in the neoadjuvant cohort.|Wilcoxon Signed Rank Test|||||||0.313
72578203|NCT02933255|144683877|OTHER||||||<|0.001||||||The reported p-value is representative of changes in CD4+ EM ki67+ T cells at week 4 post treatment compared to baseline in the lead-in metastatic castration-resistant prostate cancer cohort.|Wilcoxon Signed Rank Test|||||||<0.001
72578204|NCT02933255|144683877|OTHER|||||||0.049||||||The reported p-value is representative of changes in CD4+ EM ki67+ T cells at week 4 post treatment compared to baseline in the neoadjuvant cohort.|Wilcoxon Signed Rank Test|||||||0.049
72578205|NCT02933255|144683877|OTHER|||||||0.47||||||The reported p-value is representative of changes in CD4+ EM ki67+ T cells at week 10 post treatment compared to baseline in the lead-in metastatic castration-resistant prostate cancer cohort.|Wilcoxon Signed Rank Test|||||||0.47
72578206|NCT02933255|144683877|OTHER|||||||0.313||||||The reported p-value is representative of changes in CD4+ EM ki67+ T cells at week 10 post treatment compared to baseline in the neoadjuvant cohort.|Wilcoxon Signed Rank Test|||||||0.313
72578207|NCT02933255|144683877|OTHER|||||||0.001||||||The reported p-value is representative of changes in CD4+ ICOS+ T cells at week 4 post treatment compared to baseline in the lead-in metastatic castration-resistant prostate cancer cohort.|Wilcoxon Signed Rank Test|||||||0.001
72578208|NCT02933255|144683877|OTHER|||||||0.092||||||The reported p-value is representative of changes in CD4+ ICOS+ T cells at week 4 post treatment compared to baseline in the neoadjuvant cohort.|Wilcoxon Signed Rank Test|||||||0.092
72578209|NCT02933255|144683877|OTHER|||||||0.176||||||The reported p-value is representative of changes in CD4+ ICOS+ T cells at week 10 post treatment compared to baseline in the lead-in metastatic castration-resistant prostate cancer cohort.|Wilcoxon Signed Rank Test|||||||0.176
72578210|NCT02933255|144683877|OTHER|||||||0.232||||||The reported p-value is representative of changes in CD4+ ICOS+ T cells at week 10 post treatment compared to baseline in the neoadjuvant cohort.|Wilcoxon Signed Rank Test|||||||0.232
72578211|NCT02933255|144683877|OTHER||||||<|0.001||||||The reported p-value is representative of changes in CD8+ ki67+ T cells at week 4 post treatment compared to baseline in the lead-in metastatic castration-resistant prostate cancer cohort.|Wilcoxon Signed Rank Test|||||||<0.001
72578212|NCT02933255|144683877|OTHER|||||||0.131||||||The reported p-value is representative of changes in CD8+ ki67+ T cells at week 4 post treatment compared to baseline in the neoadjuvant cohort.|Wilcoxon Signed Rank Test|||||||0.131
72578213|NCT02933255|144683877|OTHER|||||||0.424||||||The reported p-value is representative of changes in CD8+ ki67+ T cells at week 10 post treatment compared to baseline in the lead-in metastatic castration-resistant prostate cancer cohort.|Wilcoxon Signed Rank Test|||||||0.424
72329470|NCT03037476|144184388|OTHER|General Linear Model|Slope|-0.0899||||0.266|TWO_SIDED|95.0|-0.2484|0.0685|||Mixed Models Analysis|Negative Binomial Regression||Change in past 12 month marijuana use at 6 month follow-up||0.0685|-0.2484|0.266
72578214|NCT02933255|144683877|OTHER|||||||0.438||||||The reported p-value is representative of changes in CD8+ ki67+ T cells at week 10 post treatment compared to baseline in the neoadjuvant cohort.|Wilcoxon Signed Rank Test|||||||0.438
72578215|NCT02933255|144683877|OTHER||||||<|0.001||||||The reported p-value is representative of changes in Treg ICOS+ cells at week 4 post treatment compared to baseline in the lead-in metastatic castration-resistant prostate cancer cohort.|Wilcoxon Signed Rank Test|||||||<0.001
72578216|NCT02933255|144683877|OTHER|||||||0.151||||||The reported p-value is representative of changes in Treg ICOS+ cells at week 4 post treatment compared to baseline in the neoadjuvant cohort.|Wilcoxon Signed Rank Test|||||||0.151
72578217|NCT02933255|144683877|OTHER|||||||0.569||||||The reported p-value is representative of changes in Treg ICOS+ cells at week 10 post treatment compared to baseline in the lead-in metastatic castration-resistant prostate cancer cohort.|Wilcoxon Signed Rank Test|||||||0.569
72578218|NCT02933255|144683877|OTHER|||||||0.105||||||The reported p-value is representative of changes in Treg ICOS+ cells at week 10 post treatment compared to baseline in the neoadjuvant cohort.|Wilcoxon Signed Rank Test|||||||0.105
72578219|NCT02933255|144683877|OTHER|||||||0.012||||||The reported p-value is representative of changes in NK ki67+ cells at week 4 post treatment compared to baseline in the lead-in metastatic castration-resistant prostate cancer cohort.|Wilcoxon Signed Rank Test|||||||0.012
72578220|NCT02933255|144683877|OTHER|||||||0.677||||||The reported p-value is representative of changes in NK ki67+ cells at week 4 post treatment compared to baseline in the neoadjuvant cohort.|Wilcoxon Signed Rank Test|||||||0.677
72578221|NCT02933255|144683877|OTHER|||||||0.424||||||The reported p-value is representative of changes in NK ki67+ cells at week 10 post treatment compared to baseline in the lead-in metastatic castration-resistant prostate cancer cohort.|Wilcoxon Signed Rank Test|||||||0.424
72578222|NCT02933255|144683877|OTHER|||||||0.432||||||The reported p-value is representative of changes in NK ki67+ cells at week 10 post treatment compared to baseline in the neoadjuvant cohort.|Wilcoxon Signed Rank Test|||||||0.432
72578223|NCT02933255|144683877|OTHER|||||||0.016||||||The reported p-value is representative of changes in NK NKG2D+ cells at week 4 post treatment compared to baseline in the lead-in metastatic castration-resistant prostate cancer cohort.|Wilcoxon Signed Rank Test|||||||0.016
72578224|NCT02933255|144683877|OTHER|||||||0.733||||||The reported p-value is representative of changes in NK NKG2D+ cells at week 4 post treatment compared to baseline in the neoadjuvant cohort.|Wilcoxon Signed Rank Test|||||||0.733
72543577|NCT00219557|144616974|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-55.56|||||TWO_SIDED|95.0|-212.46|101.35||||||For change in ability to plan future at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.||101.35|-212.46|
72543578|NCT00219557|144616974|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.67|||||TWO_SIDED|95.0|-62.93|96.26||||||For change in pancreatic pain at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.||96.26|-62.93|
72543579|NCT00219557|144616974|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.29|||||TWO_SIDED|95.0|-87.74|116.31||||||For change in eating related items at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.||116.31|-87.74|
72543580|NCT00219557|144616974|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|73.81|||||TWO_SIDED|95.0|7.9|139.72||||||For change in altered bowel habits at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.||139.72|7.90|
72543581|NCT00219557|144616974|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|76.19|||||TWO_SIDED|95.0|33.64|118.74||||||For change in jaundice at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.||118.74|33.64|
72543582|NCT00219557|144616974|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|28.57|||||TWO_SIDED|95.0|-64.64|121.79||||||For change in body image at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.||121.79|-64.64|
72543583|NCT00219557|144616974|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|35.71|||||TWO_SIDED|95.0|-28.11|99.53||||||For change in health care satisfaction at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.||99.53|-28.11|
72543584|NCT00219557|144616974|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.33|||||TWO_SIDED|95.0|-104.01|77.34||||||For change in sexual functioning at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.||77.34|-104.01|
72543585|NCT00219557|144616974|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-44.44|||||TWO_SIDED|95.0|-140.03|51.14||||||For change in ascites at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.||51.14|-140.03|
72543586|NCT00219557|144616974|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.76|||||TWO_SIDED|95.0|-88.45|97.98||||||For change in indigestion at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.||97.98|-88.45|
72543587|NCT00219557|144616974|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.29|||||TWO_SIDED|95.0|-54.32|82.89||||||For change in flatulence at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.||82.89|-54.32|
72543588|NCT00219557|144616974|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|23.81|||||TWO_SIDED|95.0|-66.45|114.07||||||For change in cachexia at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.||114.07|-66.45|
72543589|NCT00219557|144616974|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|31.75|||||TWO_SIDED|95.0|-56.14|119.63||||||For change in side effects at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.||119.63|-56.14|
72543590|NCT00219557|144616974|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-50.0|||||TWO_SIDED|95.0|-163.35|63.35||||||For change in fear of future health at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.||63.35|-163.35|
72543591|NCT00219557|144616974|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.29|||||TWO_SIDED|95.0|-125.23|96.66||||||For change in ability to plan future at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.||96.66|-125.23|
72543592|NCT00219557|144616974|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|25.0|||||TWO_SIDED|95.0|-45.18|95.18||||||For change in pancreatic pain at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.||95.18|-45.18|
72543593|NCT00219557|144616974|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|25.0|||||TWO_SIDED|95.0|-45.18|95.18||||||For change in eating related items at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.||95.18|-45.18|
72543594|NCT00219557|144616974|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|77.78|||||TWO_SIDED|95.0|14.55|141.0||||||For change in altered bowel habits at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.||141.00|14.55|
72543595|NCT00219557|144616974|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|86.11|||||TWO_SIDED|95.0|40.61|131.61||||||For change in jaundice at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.||131.61|40.61|
72543596|NCT00219557|144616974|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|25.0|||||TWO_SIDED|95.0|-56.48|106.48||||||For change in body image at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.||106.48|-56.48|
72543597|NCT00219557|144616974|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|47.22|||||TWO_SIDED|95.0|-37.69|132.13||||||For change in health care satisfaction at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.||132.13|-37.69|
72543598|NCT00219557|144616974|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|20.0|||||TWO_SIDED|95.0|-70.68|110.68||||||For change in sexual functioning at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.||110.68|-70.68|
72543599|NCT00219557|144616974|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-33.33|||||TWO_SIDED|95.0|-91.87|25.2||||||For change in ascites at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.||25.20|-91.87|
72543600|NCT00219557|144616974|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|27.78|||||TWO_SIDED|95.0|-41.89|97.45||||||For change in indigestion at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.||97.45|-41.89|
72543601|NCT00219557|144616974|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.67|||||TWO_SIDED|95.0|-34.03|67.36||||||For change in flatulence at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.||67.36|-34.03|
72543602|NCT00219557|144616974|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.33|||||TWO_SIDED|95.0|-100.19|116.86||||||For change in cachexia at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.||116.86|-100.19|
72543603|NCT00219557|144616974|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|25.93|||||TWO_SIDED|95.0|-53.73|105.58||||||For change in side effects at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.||105.58|-53.73|
72543604|NCT00219557|144616974|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|||||TWO_SIDED|95.0|-117.07|117.07||||||For change in ability to plan future at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.||117.07|-117.07|
72543605|NCT00219557|144616974|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.89|||||TWO_SIDED|95.0|-221.53|249.31||||||For change in pancreatic pain at Cycle 11 Day 1, mean change difference was used to compare the two treatment groups.||249.31|-221.53|
72543606|NCT00219557|144616974|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.56|||||TWO_SIDED|95.0|-260.62|271.74||||||For change in eating related items at Cycle 11 Day 1, mean change difference was used to compare the two treatment groups.||271.74|-260.62|
72543607|NCT00219557|144616974|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|66.67|||||TWO_SIDED|95.0|-152.41|285.75||||||For change in altered bowel habits at Cycle 11 Day 1, mean change difference was used to compare the two treatment groups.||285.75|-152.41|
72543608|NCT00219557|144616974|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|100.0|||||TWO_SIDED|95.0|-119.08|319.08||||||For change in jaundice at Cycle 11 Day 1, mean change difference was used to compare the two treatment groups.||319.08|-119.08|
72543609|NCT00219557|144616974|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|33.33|||||TWO_SIDED|95.0|-185.75|252.41||||||For change in body image at Cycle 11 Day 1, mean change difference was used to compare the two treatment groups.||252.41|-185.75|
72543610|NCT00219557|144616974|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|44.44|||||TWO_SIDED|95.0|-82.04|170.93||||||For change in health care satisfaction at Cycle 11 Day 1, mean change difference was used to compare the two treatment groups.||170.93|-82.04|
72543611|NCT00219557|144616974|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|||||TWO_SIDED|95.0|-733.59|733.59||||||For change in sexual functioning at Cycle 11 Day 1, mean change difference was used to compare the two treatment groups.||733.59|-733.59|
72543612|NCT00219557|144616974|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.11|||||TWO_SIDED|95.0|-202.34|180.12||||||For change in ascites at Cycle 11 Day 1, mean change difference was used to compare the two treatment groups.||180.12|-202.34|
72543613|NCT00219557|144616974|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.11|||||TWO_SIDED|95.0|-84.5|106.73||||||For change in indigestion at Cycle 11 Day 1, mean change difference was used to compare the two treatment groups.||106.73|-84.50|
72543614|NCT00219557|144616974|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.11|||||TWO_SIDED|95.0|-84.5|106.73||||||For change in flatulence at Cycle 11 Day 1, mean change difference was used to compare the two treatment groups.||106.73|-84.50|
72543615|NCT00219557|144616974|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|38.89|||||TWO_SIDED|95.0|-87.6|165.37||||||For change in cachexia at Cycle 11 Day 1, mean change difference was used to compare the two treatment groups.||165.37|-87.60|
72543616|NCT00219557|144616974|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|44.44|||||TWO_SIDED|95.0|-208.53|297.42||||||For change in side effects at Cycle 11 Day 1, mean change difference was used to compare the two treatment groups.||297.42|-208.53|
72543617|NCT00219557|144616974|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-22.22|||||TWO_SIDED|95.0|-275.19|230.75||||||For change in ability to plan future at Cycle 11 Day 1, mean change difference was used to compare the two treatment groups.||230.75|-275.19|
72543618|NCT00219557|144616974|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|58.33|||||TWO_SIDED|95.0|-491.86|608.53||||||For change in pancreatic pain at EoS, mean change difference was used to compare the two treatment groups.||608.53|-491.86|
72543619|NCT00219557|144616974|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|25.0|||||TWO_SIDED|95.0|-1258.79|1308.79||||||For change in eating related items at EoS, mean change difference was used to compare the two treatment groups.||1308.79|-1258.79|
72543620|NCT00219557|144616974|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|83.33|||||TWO_SIDED|95.0|-283.46|450.13||||||For change in altered bowel habits at EoS, mean change difference was used to compare the two treatment groups.||450.13|-283.46|
72543621|NCT00219557|144616974|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.33|||||TWO_SIDED|95.0|-175.06|191.73||||||For change in jaundice at EoS, mean change difference was used to compare the two treatment groups.||191.73|-175.06|
72543622|NCT00219557|144616974|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|||||TWO_SIDED|95.0|-733.59|733.59||||||For change in ascites at EoS, mean change difference was used to compare the two treatment groups.||733.59|-733.59|
72543623|NCT00219557|144616974|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|||||TWO_SIDED|95.0|-733.59|733.59||||||For change in indigestion at EoS, mean change difference was used to compare the two treatment groups.||733.59|-733.59|
72543624|NCT00219557|144616974|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|83.33|||||TWO_SIDED|95.0|-283.46|450.13||||||For change in flatulence at EoS, mean change difference was used to compare the two treatment groups.||450.13|-283.46|
72543625|NCT00219557|144616974|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|30.56|||||TWO_SIDED|95.0|-1375.5|1436.61||||||For change in side effects at EoS, mean change difference was used to compare the two treatment groups.||1436.61|-1375.5|
72543626|NCT02345486|144616993|SUPERIORITY||Mean Difference (Final Values)|0.7||||0.001|TWO_SIDED|95.0|0.66|0.74|||Wilcoxon (Mann-Whitney)||"reported mean difference is a difference in proportions."|||0.74|0.66|0.001
72543627|NCT03124381|144617038|NON_INFERIORITY|Non-inferiority concluded if the upper bound of the two-sided 95% confidence interval (based on ANCOVA) is less than 15 percentage points. Terms for treatment, gender, center as factors and baseline as covariate.|Mean Difference (Net)|3.19|STANDARD_ERROR_OF_MEAN|5.164|||TWO_SIDED|95.0|-7.04|13.42||||||Non-inferiority test performed after significance vs. baseline confirmed for each cell. The null hypothesis for the non-inferiority test was H0: A-B≥15%, where A and B are the mean percent change at Week 12 of global face total acne lesion count of the Gel-Cream + Acne Mask cell and Acne Mask cell, respectively.||13.42|-7.04|
72411178|NCT03893448|144330623|NON_INFERIORITY|A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevnar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio (V114 / Prevnar 13™)|0.91|||<|0.001|TWO_SIDED|95.0|0.84|1.0|||t-test, 1 sided||V114/Prevnar 13™|Serotype 9V GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||1.00|0.84|< 0.001
72411179|NCT03893448|144330623|NON_INFERIORITY|A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevnar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio (V114 / Prevnar 13™)|0.7|||<|0.001|TWO_SIDED|95.0|0.63|0.78|||t-test, 1 sided||V114/Prevnar 13™|Serotype 14 GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||0.78|0.63|< 0.001
72411180|NCT03893448|144330623|NON_INFERIORITY|A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevnar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio (V114 / Prevnar 13™)|0.76|||<|0.001|TWO_SIDED|95.0|0.7|0.83|||t-test, 1 sided||V114/Prevnar 13™|Serotype 18C GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||0.83|0.70|< 0.001
72411181|NCT03893448|144330623|NON_INFERIORITY|A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevnar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio (V114 / Prevnar 13™)|0.71|||<|0.001|TWO_SIDED|95.0|0.65|0.77|||t-test, 1 sided||V114/Prevnar 13™|Serotype 19A GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||0.77|0.65|< 0.001
72411182|NCT03893448|144330623|NON_INFERIORITY|A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevnar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio (V114 / Prevnar 13™)|0.74|||<|0.001|TWO_SIDED|95.0|0.69|0.79|||t-test, 1 sided||V114/Prevnar 13™|Serotype 19F GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||0.79|0.69|< 0.001
72411183|NCT03893448|144330623|NON_INFERIORITY|A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevnar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio (V114 / Prevnar 13™)|0.89|||<|0.001|TWO_SIDED|95.0|0.8|0.99|||t-test, 1 sided||V114/Prevnar 13™|Serotype 23F GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||0.99|0.80|< 0.001
72411184|NCT03893448|144330623|NON_INFERIORITY|A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevnar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio (V114 / Prevnar 13™)|3.64|||<|0.001|TWO_SIDED|95.0|3.33|3.98|||t-test, 1 sided||V114/Prevnar 13™|Serotype 22F IgG GMC for Serotype 22F in recipients of V114 was compared to lowest IgG GMC (Serotype 4 at 1.35 ug/mL) for shared serotype in recipients of Prevnar 13™, excluding serotype 3. GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||3.98|3.33|< 0.001
72578225|NCT02933255|144683877|OTHER|||||||0.519||||||The reported p-value is representative of changes in NK NKG2D+ cells at week 10 post treatment compared to baseline in the lead-in metastatic castration-resistant prostate cancer cohort.|Wilcoxon Signed Rank Test|||||||0.519
72411185|NCT03893448|144330623|NON_INFERIORITY|A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevnar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio (V114 / Prevnar 13™)|1.24|||<|0.001|TWO_SIDED|95.0|1.1|1.39|||t-test, 1 sided||V114/Prevnar 13™|Serotype 33F IgG GMC for Serotype 33F in recipients of V114 was compared to lowest IgG GMC (Serotype 4 at 1.35 ug/mL) for shared serotype in recipients of Prevnar 13™, excluding serotype 3. GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||1.39|1.10|< 0.001
72578226|NCT02933255|144683877|OTHER|||||||0.557||||||The reported p-value is representative of changes in NK NKG2D+ cells at week 10 post treatment compared to baseline in the neoadjuvant cohort.|Wilcoxon Signed Rank Test|||||||0.557
72578227|NCT02933255|144683877|OTHER|||||||0.034||||||The reported p-value is representative of changes in NK NKp46+ cells at week 4 post treatment compared to baseline in the lead-in metastatic castration-resistant prostate cancer cohort.|Wilcoxon Signed Rank Test|||||||0.034
72578228|NCT02933255|144683877|OTHER|||||||0.092||||||The reported p-value is representative of changes in NK NKp46+ cells at week 4 post treatment compared to baseline in the neoadjuvant cohort.|Wilcoxon Signed Rank Test|||||||0.092
72578229|NCT02933255|144683877|OTHER|||||||0.733||||||The reported p-value is representative of changes in NK NKp46+ cells at week 10 post treatment compared to baseline in the lead-in metastatic castration-resistant prostate cancer cohort.|Wilcoxon Signed Rank Test|||||||0.733
72578230|NCT02933255|144683877|OTHER|||||||0.922||||||The reported p-value is representative of changes in NK NKp46+ cells at week 10 post treatment compared to baseline in the neoadjuvant cohort.|Wilcoxon Signed Rank Test|||||||0.922
72578231|NCT02933255|144683877|OTHER|||||||0.176||||||The reported p-value is representative of changes in CD8+ naive T cells at week 4 post treatment compared to baseline in the lead-in metastatic castration-resistant prostate cancer cohort.|Wilcoxon Signed Rank Test|||||||0.176
72578232|NCT02933255|144683877|OTHER|||||||0.049||||||The reported p-value is representative of changes in CD8+ naive T cells at week 4 post treatment compared to baseline in the neoadjuvant cohort.|Wilcoxon Signed Rank Test|||||||0.049
72578233|NCT02933255|144683877|OTHER|||||||0.001||||||The reported p-value is representative of changes in CD8+ naive T cells at week 10 post treatment compared to baseline in the lead-in metastatic castration-resistant prostate cancer cohort.|Wilcoxon Signed Rank Test|||||||0.001
72578234|NCT02933255|144683877|OTHER|||||||0.563||||||The reported p-value is representative of changes in CD8+ naive T cells at week 10 post treatment compared to baseline in the neoadjuvant cohort.|Wilcoxon Signed Rank Test|||||||0.563
72578235|NCT02933255|144683877|OTHER|||||||0.012||||||The reported p-value is representative of changes in CD8+ CM T cells at week 4 post treatment compared to baseline in the lead-in metastatic castration-resistant prostate cancer cohort.|Wilcoxon Signed Rank Test|||||||0.012
72578236|NCT02933255|144683877|OTHER|||||||0.084||||||The reported p-value is representative of changes in CD8+ CM T cells at week 4 post treatment compared to baseline in the neoadjuvant cohort.|Wilcoxon Signed Rank Test|||||||0.084
72578237|NCT02933255|144683877|OTHER|||||||0.016||||||The reported p-value is representative of changes in CD8+ CM T cells at week 10 post treatment compared to baseline in the lead-in metastatic castration-resistant prostate cancer cohort.|Wilcoxon Signed Rank Test|||||||0.016
72578238|NCT02933255|144683877|OTHER|||||||0.688||||||The reported p-value is representative of changes in CD8+ CM T cells at week 10 post treatment compared to baseline in the neoadjuvant cohort.|Wilcoxon Signed Rank Test|||||||0.688
72578239|NCT02933255|144683877|OTHER|||||||0.38||||||The reported p-value is representative of changes in gMDSC at week 4 post treatment compared to baseline in the lead-in metastatic castration-resistant prostate cancer cohort.|Wilcoxon Signed Rank Test|||||||0.38
72578240|NCT02933255|144683877|OTHER|||||||0.021||||||The reported p-value is representative of changes in gMDSC at week 4 post treatment compared to baseline in the neoadjuvant cohort.|Wilcoxon Signed Rank Test|||||||0.021
72578241|NCT02933255|144683877|OTHER|||||||0.91||||||The reported p-value is representative of changes in gMDSC at week 10 post treatment compared to baseline in the lead-in metastatic castration-resistant prostate cancer cohort.|Wilcoxon Signed Rank Test|||||||0.91
72578242|NCT02933255|144683877|OTHER|||||||0.084||||||The reported p-value is representative of changes in gMDSC at week 10 post treatment compared to baseline in the neoadjuvant cohort.|Wilcoxon Signed Rank Test|||||||0.084
72329471|NCT03037476|144184388|OTHER|General Linear Model|Slope|-0.0197||||0.816|TWO_SIDED|95.0|-0.1859|0.1465|||Mixed Models Analysis|Negative Binomial Regression||Past 12 month marijuana use at 12 month follow-up||0.1465|-0.1859|0.816
72578243|NCT02933255|144683877|OTHER|||||||0.151||||||The reported p-value is representative of changes in intermediate monocytes at week 4 post treatment compared to baseline in the lead-in metastatic castration-resistant prostate cancer cohort.|Wilcoxon Signed Rank Test|||||||0.151
72578244|NCT02933255|144683877|OTHER|||||||0.042||||||The reported p-value is representative of changes in intermediate monocytes at week 4 post treatment compared to baseline in the neoadjuvant cohort.|Wilcoxon Signed Rank Test|||||||0.042
72578245|NCT02933255|144683877|OTHER|||||||0.424||||||The reported p-value is representative of changes in intermediate monocytes at week 10 post treatment compared to baseline in the lead-in metastatic castration-resistant prostate cancer cohort.|Wilcoxon Signed Rank Test|||||||0.424
72578246|NCT02933255|144683877|OTHER|||||||0.846||||||The reported p-value is representative of changes in intermediate monocytes at week 10 post treatment compared to baseline in the neoadjuvant cohort.|Wilcoxon Signed Rank Test|||||||0.846
72578247|NCT02933255|144683877|OTHER|||||||0.339||||||The reported p-value is representative of changes in non-classical monocytes at week 4 post treatment compared to baseline in the lead-in metastatic castration-resistant prostate cancer cohort.|Wilcoxon Signed Rank Test|||||||0.339
72578248|NCT02933255|144683877|OTHER|||||||0.012||||||The reported p-value is representative of changes in non-classical monocytes at week 4 post treatment compared to baseline in the neoadjuvant cohort.|Wilcoxon Signed Rank Test|||||||0.012
72578249|NCT02933255|144683877|OTHER|||||||0.622||||||The reported p-value is representative of changes in non-classical monocytes at week 10 post treatment compared to baseline in the lead-in metastatic castration-resistant prostate cancer cohort.|Wilcoxon Signed Rank Test|||||||0.622
72578250|NCT02933255|144683877|OTHER|||||||0.492||||||The reported p-value is representative of changes in non-classical monocytes at week 10 post treatment compared to baseline in the neoadjuvant cohort.|Wilcoxon Signed Rank Test|||||||0.492
72578251|NCT02933255|144683877|OTHER|||||||0.11||||||The reported p-value is representative of changes in CD4+ CM T cells at week 4 post treatment compared to baseline in the lead-in metastatic castration-resistant prostate cancer cohort.|Wilcoxon Signed Rank Test|||||||0.11
72578252|NCT02933255|144683877|OTHER|||||||0.02||||||The reported p-value is representative of changes in CD4+ CM T cells at week 4 post treatment compared to baseline in the neoadjuvant cohort.|Wilcoxon Signed Rank Test|||||||0.02
72578253|NCT02933255|144683877|OTHER|||||||0.052||||||The reported p-value is representative of changes in CD4+ CM T cells at week 10 post treatment compared to baseline in the lead-in metastatic castration-resistant prostate cancer cohort.|Wilcoxon Signed Rank Test|||||||0.052
72578254|NCT02933255|144683877|OTHER|||||||0.844||||||The reported p-value is representative of changes in CD4+ CM T cells at week 10 post treatment compared to baseline in the neoadjuvant cohort.|Wilcoxon Signed Rank Test|||||||0.844
72578255|NCT02933255|144683877|OTHER||||||>|0.999||||||The reported p-value is representative of changes in CD4+ naive T cells at week 4 post treatment compared to baseline in the lead-in metastatic castration-resistant prostate cancer cohort.|Wilcoxon Signed Rank Test|||||||>0.999
72578256|NCT02933255|144683877|OTHER|||||||0.049||||||The reported p-value is representative of changes in CD4+ naive T cells at week 4 post treatment compared to baseline in the neoadjuvant cohort.|Wilcoxon Signed Rank Test|||||||0.049
72578257|NCT02933255|144683877|OTHER|||||||0.339||||||The reported p-value is representative of changes in CD4+ naive T cells at week 10 post treatment compared to baseline in the lead-in metastatic castration-resistant prostate cancer cohort.|Wilcoxon Signed Rank Test|||||||0.339
72578258|NCT02933255|144683877|OTHER||||||>|0.999||||||The reported p-value is representative of changes in CD4+ naive T cells at week 10 post treatment compared to baseline in the neoadjuvant cohort.|Wilcoxon Signed Rank Test|||||||>0.999
72411186|NCT03893448|144330624|NON_INFERIORITY|A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevnar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio (V114 / Prevnar 13™)|0.66|||<|0.001|TWO_SIDED|95.0|0.62|0.72|||t-test, 1 sided||V114/Prevnar 13™|Serotype 1 GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||0.72|0.62|< 0.001
72411187|NCT03893448|144330624|NON_INFERIORITY|A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevnar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio (V114 / Prevnar 13™)|1.35|||<|0.001|TWO_SIDED|95.0|1.25|1.46|||t-test, 1 sided||V114/Prevnar 13™|Serotype 3 GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||1.46|1.25|< 0.001
72411188|NCT03893448|144330624|NON_INFERIORITY|A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevnar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio (V114 / Prevnar 13™)|0.77|||<|0.001|TWO_SIDED|95.0|0.71|0.84|||t-test, 1 sided||V114/Prevnar 13™|Serotype 4 GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||0.84|0.71|< 0.001
72411189|NCT03893448|144330624|NON_INFERIORITY|A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevnar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio (V114 / Prevnar 13™)|0.63|||<|0.001|TWO_SIDED|95.0|0.58|0.69|||t-test, 1 sided||V114/Prevnar 13™|Serotype 5 GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||0.69|0.58|< 0.001
72411190|NCT03893448|144330624|NON_INFERIORITY|A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevnar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio (V114 / Prevnar 13™)|0.6|||<|0.001|TWO_SIDED|95.0|0.54|0.65|||t-test, 1 sided||V114/Prevnar 13™|Serotype 6A GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||0.65|0.54|< 0.001
72411191|NCT03893448|144330624|NON_INFERIORITY|A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevnar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio (V114 / Prevnar 13™)|0.74|||<|0.001|TWO_SIDED|95.0|0.67|0.81|||t-test, 1 sided||V114/Prevnar 13™|Serotype 6B GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||0.81|0.67|< 0.001
72411192|NCT03893448|144330624|NON_INFERIORITY|A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevnar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio (V114 / Prevnar 13™)|0.7|||<|0.001|TWO_SIDED|95.0|0.65|0.77|||t-test, 1 sided||V114/Prevnar 13™|Serotype 7F GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||0.77|0.65|< 0.001
72411193|NCT03893448|144330624|NON_INFERIORITY|A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevnar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio (V114 / Prevnar 13™)|0.73|||<|0.001|TWO_SIDED|95.0|0.67|0.8|||t-test, 1 sided||V114/Prevnar 13™|Serotype 9V GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||0.80|0.67|< 0.001
72411194|NCT03893448|144330624|NON_INFERIORITY|A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevnar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio (V114 / Prevnar 13™)|0.81|||<|0.001|TWO_SIDED|95.0|0.73|0.89|||t-test, 1 sided||V114/Prevnar 13™|Serotype 14 GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||0.89|0.73|< 0.001
72411195|NCT03893448|144330624|NON_INFERIORITY|A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevnar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio (V114 / Prevnar 13™)|0.85|||<|0.001|TWO_SIDED|95.0|0.78|0.93|||t-test, 1 sided||V114/Prevnar 13™|Serotype 18C GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||0.93|0.78|< 0.001
72411196|NCT03893448|144330624|NON_INFERIORITY|A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevnar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio (V114 / Prevnar 13™)|0.74|||<|0.001|TWO_SIDED|95.0|0.68|0.8|||t-test, 1 sided||V114/Prevnar 13™|Serotype 19A GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||0.80|0.68|< 0.001
72411197|NCT03893448|144330624|NON_INFERIORITY|A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevnar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio (V114 / Prevnar 13™)|0.79|||<|0.001|TWO_SIDED|95.0|0.74|0.86|||t-test, 1 sided||V114/Prevnar 13™|Serotype 19F GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||0.86|0.74|< 0.001
72578259|NCT00451178|144683903|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.989|||||TWO_SIDED|95.0|0.223|4.393|||||Hazard ratio comparing PFS of participants with a high expression of EIF4EBP1 Cytoplasm \[(R-CHOP and Enzastaurin) and (R-CHOP) combined\] versus participants with a low expression of EIF4EBP1 Cytoplasm \[(R-CHOP and Enzastaurin) and (R-CHOP) combined\].|The correlation of biomarker EIF4EBP1 Cytoplasm with PFS.||4.393|0.223|
72578260|NCT00451178|144683903|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.071|||||TWO_SIDED|95.0|0.316|3.628|||||Hazard ratio comparing PFS of participants with a high expression of EIF4E Cytoplasm \[(R-CHOP and Enzastaurin) and (R-CHOP) combined\] versus participants with a low expression of EIF4E Cytoplasm \[(R-CHOP and Enzastaurin) and (R-CHOP) combined\].|The correlation of biomarker EIF4E Cytoplasm with PFS.||3.628|0.316|
72578261|NCT00451178|144683903|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.658|||||TWO_SIDED|95.0|0.454|6.053|||||Hazard ratio comparing PFS of participants with a high expression of HDAC2 Nucleus \[(R-CHOP and Enzastaurin) and (R-CHOP) combined\] versus participants with a low expression of HDAC2 Nucleus \[(R-CHOP and Enzastaurin) and (R-CHOP) combined\].|The correlation of biomarker HDAC2 Nucleus with PFS.||6.053|0.454|
72578262|NCT00451178|144683903|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|4.082|||||TWO_SIDED|95.0|0.455|36.628|||||Hazard ratio comparing PFS of participants with a high expression of PCREB Nucleus \[(R-CHOP and Enzastaurin) and (R-CHOP) combined\] versus participants with a low expression of PCREB Nucleus \[(R-CHOP and Enzastaurin) and (R-CHOP) combined\].|The correlation of biomarker PCREB Nucleus with PFS.||36.628|0.455|
72578263|NCT00451178|144683903|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.636|||||TWO_SIDED|95.0|0.18|2.253|||||Hazard ratio comparing PFS of participants with a high expression of PEIF3746 Cytoplasm \[(R-CHOP and Enzastaurin) and (R-CHOP) combined\] versus participants with a low expression of PEIF3746 Cytoplasm \[(R-CHOP and Enzastaurin) and (R-CHOP) combined\].|The correlation of biomarker PEIF3746 Cytoplasm with PFS.||2.253|0.180|
72578264|NCT00451178|144683903|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.362|||||TWO_SIDED|95.0|0.083|1.576|||||Hazard ratio comparing PFS of participants with a high expression of PEIF3746 Nucleus \[(R-CHOP and Enzastaurin) and (R-CHOP) combined\] versus participants with a low expression of PEIF3746 Nucleus \[(R-CHOP and Enzastaurin) and (R-CHOP) combined\].|The correlation of biomarker PEIF3746 Nucleus with PFS.||1.576|0.083|
72578265|NCT00451178|144683903|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.522|||||TWO_SIDED|95.0|0.473|4.901|||||Hazard ratio comparing PFS of participants with a high expression of PEIFS209 Cytoplasm \[(R-CHOP and Enzastaurin) and (R-CHOP) combined\] versus participants with a low expression of PEIFS209 Cytoplasm \[(R-CHOP and Enzastaurin) and (R-CHOP) combined\].|The correlation of biomarker PEIFS209 Cytoplasm with PFS.||4.901|0.473|
72578266|NCT00451178|144683903|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.908|||||TWO_SIDED|95.0|0.223|3.699|||||Hazard ratio comparing PFS of participants with a high expression of PEIFS65 Nucleus \[(R-CHOP and Enzastaurin) and (R-CHOP) combined\] versus participants with a low expression of PEIFS65 Nucleus \[(R-CHOP and Enzastaurin) and (R-CHOP) combined\].|The correlation of biomarker PEIFS65 Nucleus with PFS.||3.699|0.223|
72578267|NCT00451178|144683903|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.843|||||TWO_SIDED|95.0|0.432|7.867|||||Hazard ratio comparing PFS of participants with a high expression of PEIFT70 Nucleus \[(R-CHOP and Enzastaurin) and (R-CHOP) combined\] versus participants with a low expression of PEIFT70 Nucleus \[(R-CHOP and Enzastaurin) and (R-CHOP) combined\].|The correlation of biomarker PEIFT70 Nucleus with PFS.||7.867|0.432|
72578268|NCT00451178|144683903|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.926|||||TWO_SIDED|95.0|0.276|3.109|||||Hazard ratio comparing PFS of participants with a high expression of P GSK3B Cytoplasm \[(R-CHOP and Enzastaurin) and (R-CHOP) combined\] versus participants with a low expression of P GSK3B Cytoplasm \[(R-CHOP and Enzastaurin) and (R-CHOP) combined\].|The correlation of biomarker P GSK3B Cytoplasm with PFS.||3.109|0.276|
72578269|NCT00451178|144683903|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.985|||||TWO_SIDED|95.0|0.32|3.033|||||Hazard ratio comparing PFS of participants with a high expression of PKCb2 Cytoplasm \[(R-CHOP and Enzastaurin) and (R-CHOP) combined\] versus participants with a low expression of PKCb2 Cytoplasm \[(R-CHOP and Enzastaurin) and (R-CHOP) combined\].|The correlation of biomarker PKCb2 Cytoplasm with PFS.||3.033|0.320|
72578270|NCT00451178|144683903|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.817|||||TWO_SIDED|95.0|0.242|2.758|||||Hazard ratio comparing PFS of participants with a high expression of PTEN Cytoplasm \[(R-CHOP and Enzastaurin) and (R-CHOP) combined\] versus participants with a low expression of PTEN Cytoplasm \[(R-CHOP and Enzastaurin) and (R-CHOP) combined\].|The correlation of biomarker PTEN Cytoplasm with PFS.||2.758|0.242|
72578271|NCT04324073|144684019|SUPERIORITY||Median posterior absolute risk differenc|0.2|||||TWO_SIDED|90.0|-11.7|12.2||Posterior probability|Bayesian analysis|Adjusted for age and centre|% Confidence Interval is % Credibility interval here|||12.2|-11.7|
72578272|NCT04324073|144684020|SUPERIORITY||Median posterior Hazard Ratio|1.1|||||TWO_SIDED|90.0|0.69|1.74||Posterior probability|Bayesian analysis|HR adjusted for age and centre|% Confidence interval is % Credible interval here|||1.74|0.69|
72578273|NCT04324073|144684021|SUPERIORITY||Median posterior absolute risk differenc|-7.3|||||TWO_SIDED|90.0|-22.5|8.7||Posterior probability|Bayesian analysis|Adjusted on age and centre|% Confidence Interval is %Credible Interval here. Results are presented as the proportion not improved, so that an effective treatment would be associated with a decrease in proportion.|||8.7|-22.5|
72578274|NCT04324073|144684022|SUPERIORITY||Median posterior Hazard Ratio|1.05|||||TWO_SIDED|90.0|0.55|2.07||Posterior probability|Bayesian analysis||% Confidence Interval is % Credible Interval here|||2.07|0.55|
72578275|NCT04324073|144684023|SUPERIORITY|Day 14|Hazard Ratio (HR)|0.68|||||TWO_SIDED|95.0|0.23|2.03|||Regression, Cox|adjusted for age and sex||||2.03|0.23|
72578276|NCT04324073|144684023|SUPERIORITY||Hazard Ratio (HR)|0.65|||||TWO_SIDED|95.0|0.27|1.59|||Regression, Cox|||Day 28||1.59|0.27|
72578277|NCT04324073|144684023|SUPERIORITY||Hazard Ratio (HR)|0.7|||||TWO_SIDED|95.0|0.31|1.58|||Regression, Cox|||Day 90||1.58|0.31|
72578278|NCT04324073|144684023|SUPERIORITY||Hazard Ratio (HR)|0.95|||||TWO_SIDED|95.0|0.4|2.25|||Regression, Cox|||Day 14||2.25|0.40|
72578279|NCT04324073|144684023|SUPERIORITY||Hazard Ratio (HR)|0.89|||||TWO_SIDED|95.0|0.4|1.96|||Regression, Cox|||Day 28||1.96|0.40|
72578280|NCT04324073|144684023|SUPERIORITY||Hazard Ratio (HR)|0.74|||||TWO_SIDED|95.0|0.35|1.58|||Regression, Cox|||Day 90||1.58|0.35|
72543628|NCT03124381|144617038|SUPERIORITY|Superiority concluded if the upper bound of the two-sided 95% confidence interval of the treatment difference is less than 0. Terms for treatment, gender, and center as factors and baseline score as covariate.|Mean Difference (Net)|3.19|STANDARD_ERROR_OF_MEAN|5.164||0.538|TWO_SIDED|95.0|-7.04|13.42|||ANCOVA|||Superiority test performed after non-inferiority confirmed as described above. The null hypothesis for the superiority test was H0: A-B = 0, where A and B are the mean percent change at Week 12 of global face total acne lesion count of the Acne Mask and the Gel-Cream + Acne Mask cell, respectively.||13.42|-7.04|0.538
72543629|NCT01328054|144617091|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.31|STANDARD_ERROR_OF_MEAN|2.151|||TWO_SIDED|90.0|2.72|9.89|||||Confidence interval (CI), estimated value and dispersion value of is presented for pre dose|||9.89|2.72|
72329472|NCT03037476|144184388|OTHER|General Linear Model|Slope|-0.1031||||0.209|TWO_SIDED|95.0|-0.2639|0.0577|||Mixed Models Analysis|Negative Binomial Regression||Change in past 6 month marijuana use at 6 month follow-up||0.0577|-0.2639|0.209
72543630|NCT01328054|144617091|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.43|STANDARD_ERROR_OF_MEAN|2.059|||TWO_SIDED|90.0|3.0|9.87|||||CI, estimated value and dispersion value of is presented for 1 hour post dose|||9.87|3.00|
72543631|NCT01328054|144617091|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.71|STANDARD_ERROR_OF_MEAN|1.734|||TWO_SIDED|90.0|4.82|10.6|||||CI, estimated value and dispersion value of is presented for 2 hour post dose|||10.60|4.82|
72543632|NCT01328054|144617091|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.42|STANDARD_ERROR_OF_MEAN|2.085|||TWO_SIDED|90.0|2.94|9.89|||||CI, estimated value and dispersion value of is presented for 3 hour post dose|||9.89|2.94|
72543633|NCT01328054|144617091|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.6|STANDARD_ERROR_OF_MEAN|2.434|||TWO_SIDED|90.0|2.54|10.65|||||CI, estimated value and dispersion value of is presented for 4 hour post dose|||10.65|2.54|
72543634|NCT01328054|144617091|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.86|STANDARD_ERROR_OF_MEAN|2.573|||TWO_SIDED|90.0|1.57|10.14|||||CI, estimated value and dispersion value of is presented for 6 hour post dose|||10.14|1.57|
72543635|NCT01328054|144617091|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.91|STANDARD_ERROR_OF_MEAN|2.735|||TWO_SIDED|90.0|0.35|9.47|||||CI, estimated value and dispersion value of is presented for 8 hour post dose|||9.47|0.35|
72543636|NCT01328054|144617091|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.75|STANDARD_ERROR_OF_MEAN|2.8|||TWO_SIDED|90.0|4.08|13.42|||||CI, estimated value and dispersion value of is presented for 10 hour post dose|||13.42|4.08|
72543637|NCT01328054|144617091|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.76|STANDARD_ERROR_OF_MEAN|2.759|||TWO_SIDED|90.0|1.16|10.36|||||CI, estimated value and dispersion value of is presented for 12 hour post dose|||10.36|1.16|
72543638|NCT01328054|144617091|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.75|STANDARD_ERROR_OF_MEAN|2.164|||TWO_SIDED|90.0|0.15|7.36|||||CI, estimated value and dispersion value of is presented for 24 hour post dose|||7.36|0.15|
72543639|NCT00291330|144617113|NON_INFERIORITY_OR_EQUIVALENCE|Non inferiority margin was set up to 2.75 for the HR analysis|Hazard Ratio (HR)|1.05|||<|0.0001||95.0|0.65|1.7||Non-inferiority P-Value. Two Statistical analyses performed on primary endpoint. Both non inferiority for the risk difference and for the hazard ratio analyses to be reached in order to conclude positively on the primary endpoint.|Regression, Cox|Patients without events are censored at the end of post treatment period (day 224)||Hazard ratio vs. Warfarin (events occurring between randomisation and end of post treatment period). The time to first occurrence of the primary endpoint was compared between treatment groups using the Cox proportional hazards (PH) model, including the factors treatment, active cancer at baseline, symptomatic PE at baseline, and the interaction between active cancer and symptomatic PE.||1.70|0.65|<0.0001
72543640|NCT00291330|144617113|NON_INFERIORITY_OR_EQUIVALENCE|Non inferiority margin was set up to 3.6% for the risk difference based on KM estimates|Risk Difference (Percentage)|0.4|||<|0.0001||95.0|-0.8|1.5||Non-inferiority P-Value. Two Statistical analyses performed on primary endpoint. Both non inferiority for the risk difference and for the hazard ratio analyses to be reached in order to conclude positively on the primary endpoint.|Kaplan Meier weighted estimates|||Risk difference vs. Warfarin for Proportion of patients with VTE or death related to VTE at 6 months. Point estimate and 95% CI for the overall risk difference obtained based on the Kaplan Meier (KM) estimates at 6 months (180 days) after adjusting for the stratification factors active cancer at baseline and symptomatic PE at baseline.||1.50|-0.80|<0.0001
72543641|NCT00291330|144617113|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.1||||||95.0|0.65|1.84|||Regression, Cox|Patients without events are censored at day 180||Hazard ratio vs. Warfarin (events occurring between randomisation and the day 180). The time to first occurrence of the primary endpoint was compared between treatment groups using the Cox proportional hazards (PH) model, including the factors treatment, active cancer at baseline, symptomatic PE at baseline, and the interaction between active cancer and symptomatic PE.||1.84|0.65|
72543642|NCT00291330|144617114|SUPERIORITY_OR_OTHER||Risk Difference (Percentage)|0.3||||0.622||95.0|-1.0|1.7|||Kaplan Meier weighted estimates|||Risk difference vs. Warfarin for Proportion of patients with VTE or death at 6 months. Point estimate and 95% CI for the overall risk difference obtained based on the Kaplan Meier (KM) estimates at 6 months (180 days) after adjusting for the stratification factors active cancer at baseline and symptomatic PE at baseline.||1.70|-1.00|0.6220
72543643|NCT00291330|144617114|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.0||||0.9844||95.0|0.69|1.46|||Regression, Cox|Patients without events are censored at the end of post treatment period (day 224)||Hazard ratio vs. Warfarin (events occurring between randomisation and end of post treatment period). The time to first occurrence of the endpoint was compared between treatment groups using the Cox proportional hazards (PH) model, including the factors treatment, active cancer at baseline, symptomatic PE at baseline, and the interaction between active cancer and symptomatic PE.||1.46|0.69|0.9844
72543644|NCT00291330|144617115|SUPERIORITY_OR_OTHER||Risk Difference (Percentage)|-0.2||||0.6466||95.0|-1.1|0.7|||Kaplan Meier weighted estimates|||Risk difference vs. Warfarin for Proportion of patients with symptomatic DVT at 6 months. Point estimate and 95% CI for the overall risk difference obtained based on the Kaplan Meier (KM) estimates at 6 months (180 days) after adjusting for the stratification factors active cancer at baseline and symptomatic PE at baseline.||0.70|-1.10|0.6466
72543645|NCT00291330|144617115|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.76||||0.385||95.0|0.4|1.42|||Regression, Cox|Patients without events are censored at the end of post treatment period (day 224)||Hazard ratio vs. Warfarin (events occurring between randomisation and end of post treatment period). The time to first occurrence of the endpoint was compared between treatment groups using the Cox proportional hazards (PH) model, including the factors treatment, active cancer at baseline, symptomatic PE at baseline, and the interaction between active cancer and symptomatic PE.||1.42|0.40|0.3850
72329473|NCT03037476|144184388|OTHER|General Linear Model|Slope|-0.006||||0.944|TWO_SIDED|95.0|-0.1729|0.1608|||Mixed Models Analysis|Negative Binomial Regression||Change in past 6 month marijuana use at 12 month follow-up||0.1608|-0.1729|0.944
72578281|NCT04324073|144684024|SUPERIORITY||Median posterior OR|1.11|||||TWO_SIDED|95.0|0.53|2.34|||Proportionnal odds model|Bayesian analysis. Adjusted for age and centre.|% Confidence Interval is % Credible Interval here|Day 4||2.34|0.53|
72578282|NCT04324073|144684024|SUPERIORITY||Median posterior OR|1.02|||||TWO_SIDED|95.0|0.49|2.08|||Proportionnal odds model|Bayesian analysis. Adjusted for age and centre.|% Confidence Interval is % Credible Interval here|Day 7||2.08|0.49|
72578283|NCT04324073|144684024|SUPERIORITY||Median posterior OR|0.79|||||TWO_SIDED|95.0|0.42|1.47|||Proportionnal odds model|Bayesian analysis. Adjusted for age and centre.|% Confidence Interval is % Credible Interval here|Day 14||1.47|0.42|
72578284|NCT04324073|144684024|SUPERIORITY||Median posterior OR|0.88|||||TWO_SIDED|95.0|0.38|2.02|||Proportionnal odds model|Bayesian analysis. Adjusted for age and centre.|% Confidence Interval is % Credible Interval here|Day 4||2.02|0.38|
72578285|NCT04324073|144684024|SUPERIORITY||Median posterior OR|1.07|||||TWO_SIDED|95.0|0.47|2.4|||Proportionnal odds model|Bayesian analysis. Adjusted for age and centre.|% Confidence Interval is % Credible Interval here|Day 14||2.40|0.47|
72578286|NCT04324073|144684024|SUPERIORITY||Median posterior OR|1.13|||||TWO_SIDED|95.0|0.5|2.57|||Proportionnal odds model|Bayesian analysis. Adjusted for age and sex|% Confidence Interval is % Credible Interval here|Day 90||2.57|0.50|
72578287|NCT04324073|144684025|SUPERIORITY||Median Difference (Net)|-1.5|||||TWO_SIDED|95.0|-6.1|3.9||||adjusted on age and centre||||3.9|-6.1|
72578288|NCT04324073|144684026|SUPERIORITY||Hazard Ratio (HR)|1.06|||||TWO_SIDED|95.0|0.72|1.57|||Fine-Gray model|adjusted for age and centre||Day 28||1.57|0.72|
72578289|NCT04324073|144684026|SUPERIORITY||Hazard Ratio (HR)|1.29|||||TWO_SIDED|95.0|0.74|2.25|||Fine-Gray model|Adjusted for age and centre||Day 90||2.25|0.74|
72578290|NCT04324073|144684026|SUPERIORITY||Hazard Ratio (HR)|1.2|||||TWO_SIDED|95.0|0.59|2.44|||Fine-Gray model|adjusted for age and centre||Day 28||2.44|0.59|
72578291|NCT04324073|144684026|SUPERIORITY||Hazard Ratio (HR)|1.07|||||TWO_SIDED|95.0|0.74|1.55|||Fine-Gray model|Adjusted for age and centre||Day 90||1.55|0.74|
72578292|NCT04324073|144684027|SUPERIORITY||Hazard Ratio (HR)|1.19|||||TWO_SIDED|95.0|0.81|1.75|||Fine-Gray model|Adjusted on age and centre||Day 28||1.75|0.81|
72578293|NCT04324073|144684027|SUPERIORITY||Hazard Ratio (HR)|1.15|||||TWO_SIDED|95.0|0.8|1.67|||Fine-Gray model|Adjusted on age and centre||Day 90||1.67|0.80|
72578294|NCT04324073|144684027|SUPERIORITY||Hazard Ratio (HR)|1.21|||||TWO_SIDED|95.0|0.55|2.66|||Fine-Gray model|Adjusted on age and centre||Day 28||2.66|0.55|
72578295|NCT04324073|144684027|SUPERIORITY||Hazard Ratio (HR)|1.3|||||TWO_SIDED|95.0|0.71|2.37|||Fine-Gray model|Adjusted on age and centre||Day 90||2.37|0.71|
72578296|NCT04324073|144684028|SUPERIORITY||Hazard Ratio (HR)|0.78|||||TWO_SIDED|95.0|0.42|1.44|||Fine-Gray model|Adjusted for age and centre||Day 28||1.44|0.42|
72578297|NCT04324073|144684028|SUPERIORITY||Hazard Ratio (HR)|0.84|||||TWO_SIDED|95.0|0.49|1.47|||Fine-Gray model|adjusted for age and centre||Day 90||1.47|0.49|
72578298|NCT05833139|144684030|OTHER||Geometric mean ratio (T/R) [%]|141.2|||||TWO_SIDED|90.0|126.3|157.7|||ANOVA||Intra-individual geometric coefficient of variation (gCV%) = 18.0|"The statistical model used was an analysis of variance (ANOVA) on the logarithmic scale. AUC0-∞ was log transformed (natural logarithm) prior to fitting the ANOVA model, considering the effect 'participant' as random and treatment as fixed."||157.7|126.3|
72578299|NCT05833139|144684031|OTHER||Geometric mean ratio (T/R) [%]|126.9|||||TWO_SIDED|90.0|106.6|151.0|||ANOVA||Intra-individual geometric coefficient of variation (gCV%) = 28.7|"The statistical model used was an analysis of variance (ANOVA) on the logarithmic scale. Cmax was log transformed (natural logarithm) prior to fitting the ANOVA model, considering the effect 'participant' as random and treatment as fixed."||151.0|106.6|
72578300|NCT05833139|144684032|OTHER||Geometric mean ratio (T/R) [%]|142.8|||||TWO_SIDED|90.0|126.0|161.9|||ANOVA||Intra-individual geometric coefficient of variation (gCV%) = 20.4|"The statistical model used was an analysis of variance (ANOVA) on the logarithmic scale. AUC0-tz was log transformed (natural logarithm) prior to fitting the ANOVA model, considering the effect 'participant' as random and treatment as fixed."||161.9|126.0|
72578301|NCT03922529|144684033|SUPERIORITY||Mean Difference (Final Values)|0.5|STANDARD_ERROR_OF_MEAN|0.8||0.543|TWO_SIDED||||||Mixed Models Analysis|Adjusted for baseline value of the outcome as a covariate using linear mixed models and multiple imputation for missing data.|The adjusted difference from a model may not necessarily match the raw difference between groups.|||||0.5430
72578302|NCT03922529|144684034|SUPERIORITY||Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|0.8||0.7625|TWO_SIDED||||||Mixed Models Analysis|Adjusted for baseline value of the outcome as a covariate using linear mixed models and multiple imputation for missing data.|The adjusted difference from a model may not necessarily match the raw difference between groups.|||||0.7625
72578303|NCT03922529|144684035|SUPERIORITY||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.7||0.8842|TWO_SIDED||||||Mixed Models Analysis|Adjusted for baseline value of the outcome as a covariate using linear mixed models and multiple imputation for missing data.|The adjusted difference from a model may not necessarily match the raw difference between groups.|||||0.8842
72578304|NCT03922529|144684036|SUPERIORITY||Mean Difference (Final Values)|1.0|STANDARD_ERROR_OF_MEAN|1.2||0.4086|TWO_SIDED||||||Mixed Models Analysis|Adjusted for baseline value of the outcome as a covariate using linear mixed models and multiple imputation for missing data.|The adjusted difference from a model may not necessarily match the raw difference between groups.|||||0.4086
72578305|NCT03922529|144684037|SUPERIORITY||Mean Difference (Net)|1.0|STANDARD_ERROR_OF_MEAN|1.2||0.3841|TWO_SIDED||||||Mixed Models Analysis|Adjusted for baseline value of the outcome as a covariate using linear mixed models and multiple imputation for missing data.|The adjusted difference from a model may not necessarily match the raw difference between groups.|||||0.3841
72411198|NCT03893448|144330624|NON_INFERIORITY|A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevnar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio (V114 / Prevnar 13™)|0.61|||<|0.001|TWO_SIDED|95.0|0.56|0.68|||t-test, 1 sided||V114/Prevnar 13™|Serotype 23F GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||0.68|0.56|< 0.001
72411199|NCT03893448|144330624|NON_INFERIORITY|A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevnar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio (V114 / Prevnar 13™)|4.69|||<|0.001|TWO_SIDED|95.0|4.3|5.11|||t-test, 1 sided||V114/Prevnar 13™|Serotype 22F IgG GMC for Serotype 22F in recipients of V114 was compared to the lowest IgG GMC (Serotype 4 at 1.60 ug/mL) for shared serotype in recipients of Prevnar 13™, excluding serotype 3. GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||5.11|4.30|< 0.001
72411200|NCT03893448|144330624|NON_INFERIORITY|A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevnar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio (V114 / Prevnar 13™)|2.59|||<|0.001|TWO_SIDED|95.0|2.36|2.83|||t-test, 1 sided||V114/Prevnar 13™|Serotype 33F IgG GMC for Serotype 33F in recipients of V114 was compared to the lowest IgG GMC (Serotype 4 at 1.60 ug/mL) for shared serotype in recipients of Prevnar 13™, excluding serotype 3. GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||2.83|2.36|< 0.001
72411201|NCT03893448|144330625|NON_INFERIORITY|A conclusion of non-inferiority of Pentacel™ administered concomitantly with V114 to Pentacel™ administered concomitantly with Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevnar 13™) being greater than -10% (1-sided p-value \<0.025).|Percentage Point Difference|-0.7|||<|0.001|TWO_SIDED|95.0|-2.6|1.1||p-value is 1-sided|Miettinen & Nurminen||V114-Prevnar 13™|Diphtheria toxoid % ≥0.1 IU/mL Estimated difference, CI, and p-value are based on the Miettinen \& Nurminen method.||1.1|-2.6|< 0.001
72329474|NCT03037476|144184388|OTHER|General Linear Model|Slope|-0.0391||||0.654|TWO_SIDED|95.0|-0.2102|0.132|||Mixed Models Analysis|Negative Binomial Regression||Change in past month marijuana use at 6 month follow-up||0.1320|-0.2102|0.654
72411202|NCT03893448|144330625|NON_INFERIORITY|A conclusion of non-inferiority of Pentacel™ administered concomitantly with V114 to Pentacel™ administered concomitantly with Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevnar 13™) being greater than -5% (1-sided p-value \<0.025).|Percentage Point Difference|0.2|||<|0.001|TWO_SIDED|95.0|-0.4|0.8||p-value is 1-sided|Miettinen & Nurminen||V114-Prevnar 13™|Tetanus toxoid: % ≥0.1 IU/mL Estimated difference, CI, and p-value are based on the Miettinen \& Nurminen method.||0.8|-0.4|< 0.001
72411203|NCT03893448|144330625|NON_INFERIORITY|A conclusion of non-inferiority of Pentacel™ administered concomitantly with V114 to Pentacel™ administered concomitantly with Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevnar 13™) being greater than -10% (1-sided p-value \<0.025).|Percentage Point Difference|0.5|||<|0.001|TWO_SIDED|95.0|-0.7|1.9||p-value is 1-sided|Miettinen & Nurminen||V114-Prevnar 13™|Pertussis toxin (PT): % ≥ 5 EU/mL Estimated difference, CI, and p-value are based on the Miettinen \& Nurminen method.||1.9|-0.7|< 0.001
72411204|NCT03893448|144330625|NON_INFERIORITY|A conclusion of non-inferiority of Pentacel™ administered concomitantly with V114 to Pentacel™ administered concomitantly with Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevnar 13™) being greater than -10% (1-sided p-value \<0.025).|Percentage Point Difference|-0.3|||<|0.001|TWO_SIDED|95.0|-1.3|0.8||p-value is 1-sided|Miettinen & Nurminen||V114-Prevnar 13™|Pertussis filamentous hemagglutinin (FHA): % ≥5 EU/mL Estimated difference, CI, and p-value are based on the Miettinen \& Nurminen method.||0.8|-1.3|< 0.001
72411205|NCT03893448|144330625|NON_INFERIORITY|A conclusion of non-inferiority of Pentacel™ administered concomitantly with V114 to Pentacel™ administered concomitantly with Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevnar 13™) being greater than -10% (1-sided p-value \<0.025).|Percentage Point Difference|2.0|||<|0.001|TWO_SIDED|95.0|-3.1|7.1||p-value is 1-sided|Miettinen & Nurminen||V114-Prevnar 13™|Pertussis fimbrae types 2/3 (FIM 2/3): % ≥20 EU/mL Estimated difference, CI, and p-value are based on the Miettinen \& Nurminen method.||7.1|-3.1|< 0.001
72411206|NCT03893448|144330625|NON_INFERIORITY|A conclusion of non-inferiority of Pentacel™ administered concomitantly with V114 to Pentacel™ administered concomitantly with Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevnar 13™) being greater than -10% (1-sided p-value \<0.025).|Percentage Point Difference|1.8|||<|0.001|TWO_SIDED|95.0|-3.2|6.8||p-value is 1-sided|Miettinen & Nurminen||V114-Prevnar 13™|Pertussis pertactin (PRN): % ≥5 EU/mL Estimated difference, CI, and p-value are based on the Miettinen \& Nurminen method.||6.8|-3.2|< 0.001
72411207|NCT03893448|144330625|NON_INFERIORITY|A conclusion of non-inferiority of Pentacel™ administered concomitantly with V114 to Pentacel™ administered concomitantly with Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevnar 13™) being greater than -5% (1-sided p-value \<0.025).|Percentage Point Difference|0.0|||<|0.001|TWO_SIDED|95.0|-0.7|0.8||p-value is 1-sided|Miettinen & Nurminen||V114-Prevnar 13™|Poliovirus 1: % NAb ≥1:8 dilution Estimated difference, CI, and p-value are based on the Miettinen \& Nurminen method.||0.8|-0.7|< 0.001
72411208|NCT03893448|144330625|NON_INFERIORITY|A conclusion of non-inferiority of Pentacel™ administered concomitantly with V114 to Pentacel™ administered concomitantly with Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevnar 13™) being greater than -5% (1-sided p-value \<0.025).|Percentage Point Difference|0.0|||<|0.001|TWO_SIDED|95.0|-0.6|0.6||p-value is 1-sided|Miettinen & Nurminen||V114-Prevnar 13™|Poliovirus 2: % NAb ≥1:8 dilution Estimated difference, CI, and p-value are based on the Miettinen \& Nurminen method.||0.6|-0.6|< 0.001
72578306|NCT03922529|144684038|SUPERIORITY||Mean Difference (Final Values)|1.7|STANDARD_ERROR_OF_MEAN|1.2||0.1393|TWO_SIDED||||||Mixed Models Analysis|Adjusted for baseline value of the outcome as a covariate using linear mixed models and multiple imputation for missing data.|||The adjusted difference from a model may not necessarily match the raw difference between groups.|||0.1393
72578307|NCT03922529|144684039|SUPERIORITY||Mean Difference (Final Values)|-1.1|STANDARD_ERROR_OF_MEAN|12.3||0.9257|TWO_SIDED||||||Mixed Models Analysis|Adjusted for baseline value of the outcome as a covariate using linear mixed models and multiple imputation for missing data.|The adjusted difference from a model may not necessarily match the raw difference between groups.|||||0.9257
72578308|NCT03922529|144684040|SUPERIORITY||Mean Difference (Final Values)|-5.2|STANDARD_ERROR_OF_MEAN|11.8||0.6588|TWO_SIDED||||||Mixed Models Analysis|Adjusted for baseline value of the outcome as a covariate using linear mixed models and multiple imputation for missing data.|The adjusted difference from a model may not necessarily match the raw difference between groups.|||||0.6588
72578309|NCT03922529|144684041|SUPERIORITY||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|13.0||0.992|TWO_SIDED||||||Mixed Models Analysis|Adjusted for baseline value of the outcome as a covariate using linear mixed models and multiple imputation for missing data.|The adjusted difference from a model may not necessarily match the raw difference between groups.|||||0.9920
72578310|NCT03922529|144684042|SUPERIORITY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.3||0.9504|TWO_SIDED||||||Mixed Models Analysis|Adjusted for baseline value of the outcome as a covariate using linear mixed models and multiple imputation for missing data.|The adjusted difference from a model may not necessarily match the raw difference between groups.|||||0.9504
72578311|NCT03922529|144684043|SUPERIORITY||Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|0.3||0.6228|TWO_SIDED||||||Mixed Models Analysis|Adjusted for baseline value of the outcome as a covariate using linear mixed models and multiple imputation for missing data.|The adjusted difference from a model may not necessarily match the raw difference between groups.|||||0.6228
72578312|NCT03922529|144684044|SUPERIORITY||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.3||0.7966|TWO_SIDED||||||Mixed Models Analysis|Adjusted for baseline value of the outcome as a covariate using linear mixed models and multiple imputation for missing data.|The adjusted difference from a model may not necessarily match the raw difference between groups.|||||0.7966
72578313|NCT03922529|144684045|SUPERIORITY||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.1||0.5071|TWO_SIDED||||||Mixed Models Analysis|Adjusted for baseline value of the outcome as a covariate using linear mixed models and multiple imputation for missing data.|The adjusted difference from a model may not necessarily match the raw difference between groups.|||||0.5071
72578314|NCT03922529|144684046|SUPERIORITY||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.1||0.5553|TWO_SIDED||||||Mixed Models Analysis|Adjusted for baseline value of the outcome as a covariate using linear mixed models and multiple imputation for missing data.|The adjusted difference from a model may not necessarily match the raw difference between groups.|||||0.5553
72578315|NCT03922529|144684047|SUPERIORITY||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.1||0.1194|TWO_SIDED||||||Mixed Models Analysis|Adjusted for baseline value of the outcome as a covariate using linear mixed models and multiple imputation for missing data.|The adjusted difference from a model may not necessarily match the raw difference between groups.|||||0.1194
72578316|NCT03922529|144684048|SUPERIORITY||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.8||0.9012|TWO_SIDED||||||Mixed Models Analysis|Adjusted for baseline value of the outcome as a covariate using linear mixed models and multiple imputation for missing data.|The adjusted difference from a model may not necessarily match the raw difference between groups.|||||0.9012
72578317|NCT03922529|144684049|SUPERIORITY||Mean Difference (Final Values)|0.7|STANDARD_ERROR_OF_MEAN|0.9||0.4279|TWO_SIDED||||||Mixed Models Analysis|Adjusted for baseline value of the outcome as a covariate using linear mixed models and multiple imputation for missing data.|The adjusted difference from a model may not necessarily match the raw difference between groups.|||||0.4279
72578318|NCT03922529|144684050|SUPERIORITY||Mean Difference (Final Values)|1.1|STANDARD_ERROR_OF_MEAN|0.8||0.1932|TWO_SIDED||||||Mixed Models Analysis|Adjusted for baseline value of the outcome as a covariate using linear mixed models and multiple imputation for missing data.|The adjusted difference from a model may not necessarily match the raw difference between groups.|||||0.1932
72543646|NCT00291330|144617116|SUPERIORITY_OR_OTHER||Risk Difference (Percentage)|0.3||||0.2981||95.0|-0.3|1.0|||Kaplan Meier weighted estimates|||Risk difference vs. Warfarin for Proportion of patients with symptomatic non-fatal PE at 6 months. Point estimate and 95% CI for the overall risk difference obtained based on the Kaplan Meier (KM) estimates at 6 months (180 days) after adjusting for the stratification factors active cancer at baseline and symptomatic PE at baseline.||1.00|-0.30|0.2981
72578319|NCT03922529|144684051|SUPERIORITY||Mean Difference (Final Values)|1.4|STANDARD_ERROR_OF_MEAN|1.2||0.2723|TWO_SIDED||||||Mixed Models Analysis|Adjusted for baseline value of the outcome as a covariate using linear mixed models and multiple imputation for missing data.|The adjusted difference from a model may not necessarily match the raw difference between groups.|||||0.2723
72578320|NCT03922529|144684052|SUPERIORITY||Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|1.2||0.8951|TWO_SIDED||||||Mixed Models Analysis|Adjusted for baseline value of the outcome as a covariate using linear mixed models and multiple imputation for missing data.|The adjusted difference from a model may not necessarily match the raw difference between groups.|||||0.8951
72543647|NCT00291330|144617116|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.0||||0.1092||95.0|0.86|4.68|||Regression, Cox|Patients without events are censored at the end of post treatment period (day 224)||Hazard ratio vs. Warfarin (events occurring between randomisation and end of post treatment period). The time to first occurrence of the endpoint was compared between treatment groups using the Cox proportional hazards (PH) model, including the factors treatment, active cancer at baseline, symptomatic PE at baseline, and the interaction between active cancer and symptomatic PE.||4.68|0.86|0.1092
72543648|NCT00291330|144617117|SUPERIORITY_OR_OTHER||Risk Difference (Percentage)|-0.3||||0.5327||95.0|-1.2|0.6|||Kaplan Meier weighted estimates|||Risk difference at 6 months vs. Warfarin for Proportion of patients who died due to VTE . Point estimate and 95% CI for the overall risk difference obtained based on the Kaplan Meier (KM) estimates at 6 months (180 days) after adjusting for the stratification factors active cancer at baseline and symptomatic PE at baseline.||0.60|-1.20|0.5327
72543649|NCT00291330|144617117|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.33||||0.3332||95.0|0.03|3.15|||Regression, Cox|Patients without events are censored at the end of post treatment period (day 224)||Hazard ratio vs. Warfarin (events occurring between randomisation and end of post treatment period). The time to first occurrence of the endpoint was compared between treatment groups using the Cox proportional hazards (PH) model, including the factors treatment, active cancer at baseline, symptomatic PE at baseline, and the interaction between active cancer and symptomatic PE.||3.15|0.03|0.3332
72543650|NCT00291330|144617118|SUPERIORITY_OR_OTHER||Risk Difference (Percentage)|-0.1||||0.8018||95.0|-1.0|0.8|||Kaplan Meier weighted estimates|||Risk difference at 6 months vs. Warfarin for Proportion of patients who died from any cause. Point estimate and 95% CI for the overall risk difference obtained based on the Kaplan Meier (KM) estimates at 6 months (180 days) after adjusting for the stratification factors active cancer at baseline and symptomatic PE at baseline.||0.80|-1.00|0.8018
72543651|NCT00291330|144617118|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.94||||0.8203||95.0|0.54|1.63|||Regression, Cox|Patients without events are censored at the end of post treatment period (day 224)||Hazard ratio vs. Warfarin (events occurring between randomisation and end of post treatment period). The time to first occurrence of the endpoint was compared between treatment groups using the Cox proportional hazards (PH) model, including the factors treatment, active cancer at baseline, symptomatic PE at baseline, and the interaction between active cancer and symptomatic PE.||1.63|0.54|0.8203
72543652|NCT00291330|144617119|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.82||||0.5063||95.0|0.45|1.48|||Regression, Cox|||Hazard ratio vs. Warfarin for the category major bleeding events (events occurring between 1st intake of study drug and last intake of study drug + 6 days). The time to first occurrence of the endpoint was compared between treatment groups using the Cox proportional hazards (PH) model, including the factors treatment, active cancer at baseline, symptomatic PE at baseline, and the interaction between active cancer and symptomatic PE.||1.48|0.45|0.5063
72543653|NCT00291330|144617119|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.71||||0.0002|TWO_SIDED|95.0|0.59|0.85|||Regression, Cox|||Hazard ratio vs. Warfarin for the category of any bleeding events (events occurring between 1st intake of study drug and last intake of study drug + 6 days). The time to first occurrence of the endpoint was compared between treatment groups using the Cox proportional hazards (PH) model, including the factors treatment, active cancer at baseline, symptomatic PE at baseline, and the interaction between active cancer and symptomatic PE.||0.85|0.59|0.0002
72543654|NCT02462382|144617159|EQUIVALENCE|The univariate analyses were conducted using Independent t-Tests for continuous variables and Fisher Exact Tests or Chi-Square Tests of Independence for categorical comparisons.|Fisher Exact Tests|0.041||||0.006|TWO_SIDED|||||POD 1 1cm incision.|Chi-squared|||Comparisons of pain scores using a Visual Analog Scale (VAS) based on Post-Operative Day (POD).||||.006
72578321|NCT03922529|144684053|SUPERIORITY||Mean Difference (Final Values)|1.3|STANDARD_ERROR_OF_MEAN|1.2||0.2574|TWO_SIDED||||||Mixed Models Analysis|Adjusted for baseline value of the outcome as a covariate using linear mixed models and multiple imputation for missing data.|The adjusted difference from a model may not necessarily match the raw difference between groups.|||||0.2574
72543655|NCT00409188|144617183|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.893||||0.1566|TWO_SIDED|95.0|0.763|1.044|||Regression, Cox|||||1.044|0.763|0.1566
72543656|NCT00409188|144617184|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.845||||0.0226|TWO_SIDED|95.0|0.732|0.977|||Regression, Cox|||||0.977|0.732|0.0226
72543657|NCT00409188|144617185|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.868||||0.0528|TWO_SIDED|95.0|0.752|1.002|||Regression, Cox|||||1.002|0.752|0.0528
72543658|NCT00433381|144617222|OTHER|||||||||||||||||Null hypothesis: 20% of patients progression-free at six months. Alternative hypothesis: 35%. Type I and II error rates = 0.10. Required sample size = 57.|The determination of treatment efficacy was to be made made based on the following rules: If 16 or more of the cases (16/57=28.1%) are progression free and alive at 6 months, then reject the null hypothesis that the rate is no better than 20%. If 15 or fewer of the cases (15/57=26.3%) are progression free and alive at 6 months, then reject the alternative hypothesis that the rate is at least 35%.|||
72411209|NCT03893448|144330625|NON_INFERIORITY|A conclusion of non-inferiority of Pentacel™ administered concomitantly with V114 to Pentacel™ administered concomitantly with Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevnar 13™) being greater than -5% (1-sided p-value \<0.025).|Percentage Point Difference|0.0|||<|0.001|TWO_SIDED|95.0|-0.6|0.6||p-value is 1-sided|Miettinen & Nurminen||V114-Prevnar 13™|Poliovirus 3: % NAb ≥1:8 dilution Estimated difference, CI, and p-value are based on the Miettinen \& Nurminen method.||0.6|-0.6|< 0.001
72411210|NCT03893448|144330625|NON_INFERIORITY|A conclusion of non-inferiority of Pentacel™ administered concomitantly with V114 to Pentacel™ administered concomitantly with Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevnar 13™) being greater than -10% (1-sided p-value \<0.025).|Percentage Point Difference|-1.4|||<|0.001|TWO_SIDED|95.0|-4.3|1.5||p-value is 1-sided|Miettinen & Nurminen||V114-Prevnar 13™|Haemophilus influenzae Type B polyribosylribitol phosphate (Hib-PRP): % ≥0.15 ug/mL Estimated difference, CI, and p-value are based on the Miettinen \& Nurminen method.||1.5|-4.3|< 0.001
72411211|NCT03893448|144330626|NON_INFERIORITY|A conclusion of non-inferiority of Pentacel™ administered concomitantly with V114 to Pentacel™ administered concomitantly with Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevnar 13™) being \>0.67 (1-sided p-value \<0.025).|GMC Ratio (V114 / Prevnar 13™)|0.99|||<|0.001|TWO_SIDED|95.0|0.89|1.09|||t-test, 1 sided||V114/Prevnar 13™|Pertussis - PT GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||1.09|0.89|< 0.001
72411212|NCT03893448|144330626|NON_INFERIORITY|A conclusion of non-inferiority of Pentacel™ administered concomitantly with V114 to Pentacel™ administered concomitantly with Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevnar 13™) being \>0.67 (1-sided p-value \<0.025).|GMC Ratio (V114 / Prevnar 13™)|0.98|||<|0.001|TWO_SIDED|95.0|0.87|1.09|||t-test, 1 sided||V114/Prevnar 13™|Pertussis - FHA GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||1.09|0.87|< 0.001
72411213|NCT03893448|144330626|NON_INFERIORITY|A conclusion of non-inferiority of Pentacel™ administered concomitantly with V114 to Pentacel™ administered concomitantly with Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevnar 13™) being \>0.67 (1-sided p-value \<0.025).|GMC Ratio (V114 / Prevnar 13™)|1.08|||<|0.001|TWO_SIDED|95.0|0.91|1.28|||t-test, 1 sided||V114/Prevnar 13™|Pertussis - FIM 2/3 GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||1.28|0.91|< 0.001
72411214|NCT03893448|144330626|NON_INFERIORITY|A conclusion of non-inferiority of Pentacel™ administered concomitantly with V114 to Pentacel™ administered concomitantly with Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevnar 13™) being \>0.67 (1-sided p-value \<0.025).|GMC Ratio (V114 / Prevnar 13™)|1.0|||<|0.001|TWO_SIDED|95.0|0.84|1.19|||t-test, 1 sided||V114/Prevnar 13™|Pertussis - PRN GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||1.19|0.84|< 0.001
72411215|NCT03893448|144330627|NON_INFERIORITY|A conclusion of non-inferiority of VAQTA™ administered concomitantly with V114 to VAQTA™ administered concomitantly with Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevnar 13™) being greater than -10% (1-sided p-value \<0.025).|Percentage Point Difference|0.3|||<|0.001|TWO_SIDED|95.0|-1.6|2.2||p value is 1-sided|Miettinen & Nurminen||V114-Prevnar 13™|Estimated difference, CI, and p-value are based on the Miettinen \& Nurminen method.||2.2|-1.6|< 0.001
72411216|NCT03893448|144330628|NON_INFERIORITY|A conclusion of non-inferiority of M-M-R™ II administered concomitantly with V114 to M-M-R™ II administered concomitantly with Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevnar 13™) being greater than -5% (1-sided p-value \<0.025).|Percentage Point Difference|-0.2|||<|0.001|TWO_SIDED|95.0|-1.8|1.3||p-value is 1-sided|Miettinen & Nurminen||V114-Prevnar 13™|Measles antigen ≥255 mIU/mL Estimated difference, CI, and p-value are based on the Miettinen \& Nurminen method.||1.3|-1.8|< 0.001
72411217|NCT03893448|144330628|NON_INFERIORITY|A conclusion of non-inferiority of M-M-R™ II administered concomitantly with V114 to M-M-R™ II administered concomitantly with Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevnar 13™) being greater than -5% (1-sided p-value \<0.025).|Percentage Point Difference|-1.7|||<|0.001|TWO_SIDED|95.0|-3.8|0.2||p-value is 1-sided|Miettinen & Nurminen||V114-Prevnar 13™|Mumps antigen ≥10 mumps Ab units/mL Estimated difference, CI, and p-value are based on the Miettinen \& Nurminen method.||0.2|-3.8|< 0.001
72329475|NCT03037476|144184388|OTHER|General Linear Model|Slope|-0.0646||||0.481|TWO_SIDED|95.0|-0.2444|0.1152|||Mixed Models Analysis|Negative Binomial Regression||Change in past month marijuana use at 12 month follow-up||0.1152|-0.2444|0.481
72578322|NCT03922529|144684054|SUPERIORITY||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|1.0||0.8307|TWO_SIDED||||||Mixed Models Analysis|Adjusted for baseline value of the outcome as a covariate using linear mixed models and multiple imputation for missing data.|The adjusted difference from a model may not necessarily match the raw difference between groups.|||||0.8307
72578323|NCT03922529|144684055|SUPERIORITY||Mean Difference (Final Values)|0.5|STANDARD_ERROR_OF_MEAN|1.0||0.614|TWO_SIDED||||||Mixed Models Analysis|Adjusted for baseline value of the outcome as a covariate using linear mixed models and multiple imputation for missing data.|The adjusted difference from a model may not necessarily match the raw difference between groups.|||||0.6140
72578324|NCT03922529|144684056|SUPERIORITY||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|1.0||0.7327|TWO_SIDED||||||Mixed Models Analysis|Adjusted for baseline value of the outcome as a covariate using linear mixed models and multiple imputation for missing data.|The adjusted difference from a model may not necessarily match the raw difference between groups.|||||0.7327
72578325|NCT03922529|144684057|SUPERIORITY|||||||0.7651|||||||Wilcoxon rank sum|||||||0.7651
72578326|NCT03922529|144684058|SUPERIORITY||Incident Rate Ratio|1.15||||0.3974|TWO_SIDED|95.0|0.83|1.59|||Negative binomial regression models|||||1.59|0.83|0.3974
72578327|NCT03922529|144684059|SUPERIORITY||Mean Difference (Final Values)|1.7|STANDARD_ERROR_OF_MEAN|1.5||0.2727|TWO_SIDED||||||Mixed Models Analysis|Adjusted for baseline value of the outcome as a covariate using linear mixed models and multiple imputation for missing data.|The adjusted difference from a model may not necessarily match the raw difference between groups.|||||0.2727
72578328|NCT03922529|144684060|SUPERIORITY||Mean Difference (Final Values)|1.2|STANDARD_ERROR_OF_MEAN|1.5||0.4269|TWO_SIDED||||||Mixed Models Analysis|Adjusted for baseline value of the outcome as a covariate using linear mixed models and multiple imputation for missing data.|The adjusted difference from a model may not necessarily match the raw difference between groups.|||||0.4269
72578329|NCT03922529|144684061|SUPERIORITY||Mean Difference (Final Values)|1.2|STANDARD_ERROR_OF_MEAN|1.6||0.4354|TWO_SIDED||||||Mixed Models Analysis|Adjusted for baseline value of the outcome as a covariate using linear mixed models and multiple imputation for missing data.|The adjusted difference from a model may not necessarily match the raw difference between groups.|||||0.4354
72578330|NCT03922529|144684062|SUPERIORITY||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.4||0.8695|TWO_SIDED||||||Mixed Models Analysis|Adjusted for baseline value of the outcome as a covariate using linear mixed models and multiple imputation for missing data.|The adjusted difference from a model may not necessarily match the raw difference between groups.|||||0.8695
72578331|NCT03922529|144684063|SUPERIORITY||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.4||0.7075|TWO_SIDED||||||Mixed Models Analysis|Adjusted for baseline value of the outcome as a covariate using linear mixed models and multiple imputation for missing data.|The adjusted difference from a model may not necessarily match the raw difference between groups.|||||0.7075
72578332|NCT03922529|144684064|SUPERIORITY||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.5||0.8936|TWO_SIDED||||||Mixed Models Analysis|Adjusted for baseline value of the outcome as a covariate using linear mixed models and multiple imputation for missing data.|The adjusted difference from a model may not necessarily match the raw difference between groups.|||||0.8936
72578333|NCT03922529|144684065|SUPERIORITY|||||||0.2794|||||||Chi-squared|||||||0.2794
72578334|NCT03922529|144684066|SUPERIORITY|||||||0.6177|||||||Chi-squared|||||||0.6177
72578335|NCT03922529|144684067|SUPERIORITY|||||||0.144|||||||Chi-squared|||||||0.1440
72578336|NCT03922529|144684068|SUPERIORITY|||||||0.1122|||||||Chi-squared|||||||0.1122
72578337|NCT03922529|144684069|SUPERIORITY||Odds Ratio (OR)|1.01||||0.9653|TWO_SIDED|95.0|0.63|1.62|||Regression, Logistic|||||1.62|0.63|0.9653
72578338|NCT01277601|144684082|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Raw p-values comparing treatments were based on a log-rank test stratified by HBeAg status and viral genotype.|Log Rank|||||||< 0.001
72578339|NCT01277601|144684082|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED|||||Raw p-values comparing treatments were based on a log-rank test stratified by HBeAg status and viral genotype.|Log Rank|||||||0.002
72578340|NCT03785600|144684098|OTHER||||||<|0.02||||||a priori threshold is \<0.05.|t-test, 2 sided|||||||<0.02
72578341|NCT02291510|144684106|SUPERIORITY_OR_OTHER||% Ratio of LS Means|35.4|||<|0.001|TWO_SIDED|90.0|32.27|38.74|||ANOVA|Included treatment, sequence, and period and as fixed effects and subject nested within sequence as a random effect.||2000 mg Met XR QD is the denominator for the % ratio of least squares (LS) means and the comparator for the p-values.||38.74|32.27|<0.001
72578342|NCT02291510|144684106|SUPERIORITY_OR_OTHER||% Ratio of LS Means|52.3|||<|0.001|TWO_SIDED|90.0|47.77|57.36|||ANOVA|Included treatment, sequence, and period and as fixed effects and subject nested within sequence as a random effect.||2000 mg Met XR QD is the denominator for the % ratio of LS means and the comparator for the p-values.||57.36|47.77|<0.001
72578343|NCT02291510|144684106|SUPERIORITY_OR_OTHER||% Ratio of LS Means|32.1|||<|0.001|TWO_SIDED|90.0|29.3|35.18|||ANOVA|Included treatment, sequence, and period and as fixed effects and subject nested within sequence as a random effect.||1000 mg Met IR BID is the denominator for the % ratio of LS means and the comparator for the p-values.||35.18|29.30|<0.001
72329476|NCT03037476|144184389|OTHER|General Linear Model|Slope|-0.0411||||0.487|TWO_SIDED|95.0|-0.1569|0.0747|||Mixed Models Analysis|Negative Binomial Regression||Change in RMPI count at 6 month follow-up||0.0747|-0.1569|0.487
72578344|NCT02291510|144684106|SUPERIORITY_OR_OTHER||% Ratio of LS Means|47.5|||<|0.001|TWO_SIDED|90.0|43.38|52.09|||ANOVA|Included treatment, sequence, and period and as fixed effects and subject nested within sequence as a random effect.||1000 mg Met IR BID is the denominator for the % ratio of LS means and the comparator for the p-values.||52.09|43.38|<0.001
72578345|NCT02291510|144684106|SUPERIORITY_OR_OTHER||% Ratio of LS Means|110.1||||0.0832|TWO_SIDED|90.0|100.5|120.68|||ANOVA|Included treatment, sequence, and period and as fixed effects and subject nested within sequence as a random effect.||2000 mg Met XR QD is the denominator for the % ratio of LS means and the comparator for the p-values.||120.68|100.50|0.0832
72578346|NCT02291510|144684107|SUPERIORITY_OR_OTHER||% Ratio of LS Means|35.9|||<|0.001|TWO_SIDED|90.0|32.43|39.77|||ANOVA|Included treatment, sequence, and period and as fixed effects and subject nested within sequence as a random effect.||2000 mg Met XR QD is the denominator for the % ratio of LS means and the comparator for the p-values.||39.77|32.43|<0.001
72329477|NCT03037476|144184389|OTHER|General Linear Model|Slope|0.0177||||0.772|TWO_SIDED|95.0|-0.1021|0.1375|||Mixed Models Analysis|Negative Binomial Regression||Change in RMPI count at 12 month follow-up||0.1375|-0.1021|0.772
72578347|NCT02291510|144684107|SUPERIORITY_OR_OTHER||% Ratio of LS Means|53.0|||<|0.001|TWO_SIDED|90.0|47.88|58.71|||ANOVA|Included treatment, sequence, and period and as fixed effects and subject nested within sequence as a random effect.||2000 mg Met XR QD is the denominator for the % ratio of LS means and the comparator for the p-values.||58.71|47.88|<0.001
72578348|NCT02291510|144684107|SUPERIORITY_OR_OTHER||% Ratio of LS Means|45.3|||<|0.001|TWO_SIDED|90.0|40.88|50.13|||ANOVA|Included treatment, sequence, and period and as fixed effects and subject nested within sequence as a random effect.||1000 mg Met IR BID is the denominator for the % ratio of LS means and the comparator for the p-values.||50.13|40.88|<0.001
72578349|NCT02291510|144684107|SUPERIORITY_OR_OTHER||% Ratio of LS Means|66.8|||<|0.001|TWO_SIDED|90.0|60.34|74.0|||ANOVA|Included treatment, sequence, and period and as fixed effects and subject nested within sequence as a random effect.||1000 mg Met IR BID is the denominator for the % ratio of LS means and the comparator for the p-values.||74.00|60.34|<0.001
72578350|NCT02291510|144684107|SUPERIORITY_OR_OTHER||% Ratio of LS Means|79.3||||0.0004|TWO_SIDED|90.0|71.65|87.86|||ANOVA|Included treatment, sequence, and period and as fixed effects and subject nested within sequence as a random effect.||2000 mg Met XR QD is the denominator for the % ratio of LS means and the comparator for the p-values.||87.86|71.65|0.0004
72578351|NCT02567435|144684108|SUPERIORITY||3-Year EFS|65.8||||0.44|TWO_SIDED||||||Log Rank|||||||0.44
72578352|NCT02567435|144684109|SUPERIORITY||3-Year OS|78.2||||0.56|TWO_SIDED||||||Log Rank|||||||0.56
72578353|NCT01272037|144684133|OTHER||Hazard Ratio (HR)|1.02||||0.35|TWO_SIDED|95.0|0.98|1.05|||Regression, Cox|A Cox model was used that included treatment arm, recurrence score, menopausal status, and the chemotherapy\*recurrence score interaction term.||This test describes the interaction of the treatment arm with the recurrence score in the analysis of invasive disease-free survival in the overall study population, to determine whether chemotherapy benefit depends on the recurrence score. If the interaction was statistically significant, the interaction term was planned to be included in the Cox model to evaluate the invasive disease-free survival outcome.||1.05|0.98|0.35
72578354|NCT01272037|144684133|OTHER||Hazard Ratio (HR)|1.71||||0.008|TWO_SIDED|95.0|1.15|2.54|||Regression, Cox|A Cox model was used that included treatment arm, recurrence score, menopausal status, and the chemotherapy\*menopausal status interaction term.||This test describes the interaction of the treatment arm with menopausal status (one of the study stratification factors) in the analysis of invasive disease-free survival in the overall study population, to determine whether chemotherapy benefit depends on menopausal status. If the interaction was statistically significant, separate analyses of IDFS were planned to be conducted by menopausal status.||2.54|1.15|0.008
72578355|NCT01272037|144684133|SUPERIORITY||Hazard Ratio (HR)|0.6||||0.002|TWO_SIDED|95.0|0.43|0.83|||Regression, Cox||To compare the Chemo and Endocrine Therapy arm to the Endocrine Therapy Alone arm, a Cox model was used with adjustment for the continuous recurrence score.|This analysis includes only premenopausal participants.||0.83|0.43|0.002
72578356|NCT01272037|144684133|SUPERIORITY||Hazard Ratio (HR)|1.02||||0.89|TWO_SIDED|95.0|0.82|1.26|||Regression, Cox||To compare the Chemo and Endocrine Therapy arm to the Endocrine Therapy Alone arm, a Cox model was used with adjustment for the continuous recurrence score.|This analysis includes only postmenopausal participants.||1.26|0.82|0.89
72578357|NCT01272037|144684140|SUPERIORITY||Hazard Ratio (HR)|0.58||||0.009|TWO_SIDED|95.0|0.39|0.87|||Regression, Cox|||This analysis includes only premenopausal participants.|To compare DRFS between the Chemo and Endocrine Therapy arm and the Endocrine Therapy Alone arm, a Cox model was used with adjustment for the continuous recurrence score.|0.87|0.39|0.009
72411218|NCT03893448|144330628|NON_INFERIORITY|A conclusion of non-inferiority of M-M-R™ II administered concomitantly with V114 to M-M-R™ II administered concomitantly with Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevnar 13™) being greater than -5% (1-sided p-value \<0.025).|Percentage Point Difference|-0.9|||<|0.001|TWO_SIDED|95.0|-2.3|0.5||p-value is 1-sided|Miettinen & Nurminen||V114-Prevnar 13™|Rubella antigen ≥10 IU/mL Estimated difference, CI, and p-value are based on the Miettinen \& Nurminen method.||0.5|-2.3|< 0.001
72411219|NCT03893448|144330629|NON_INFERIORITY|A conclusion of non-inferiority of VARIVAX™ administered concomitantly with V114 to VARIVAX™ administered concomitantly with Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevnar 13™) being greater than -10% (1-sided p-value \<0.025).|Percentage Point Difference|-1.3|||<|0.001|TWO_SIDED|95.0|-3.2|0.5||p-value is 1-sided|Miettinen & Nurminen||V114-Prevnar 13™|Estimated difference, CI, and p-value are based on the Miettinen \& Nurminen method.||0.5|-3.2|< 0.001
72329478|NCT03037476|144184390|OTHER|General Linear Model|Slope|0.1285||||0.075|TWO_SIDED|95.0|-0.0131|0.2702|||Mixed Models Analysis|Negative Binomial Regression||Change in PBS count at 6 month follow up||0.2702|-0.0131|0.075
72411220|NCT03893448|144330630|NON_INFERIORITY|A conclusion of non-inferiority of HIBERIX™ administered concomitantly with V114 to HIBERIX™ administered concomitantly with Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevnar 13™) being greater than -10% (1-sided p-value \<0.025).|Percentage Point Difference|-1.1|||<|0.001|TWO_SIDED|95.0|-2.2|-0.5||p-value is 1-sided|Miettinen & Nurminen||V114-Prevnar 13™|Estimated difference, CI, and p-value are based on the Miettinen \& Nurminen method.||-0.5|-2.2|< 0.001
72329479|NCT03037476|144184390|OTHER|General Linear Model|Slope|0.0936||||0.207|TWO_SIDED|95.0|-0.0517|0.2388|||Mixed Models Analysis|Negative Binomial Regression||Change in PBS count at 12 month follow up||0.2388|-0.0517|0.207
72578358|NCT01272037|144684140|SUPERIORITY||Hazard Ratio (HR)|1.05||||0.7|TWO_SIDED|95.0|0.81|1.37|||Regression, Cox||To compare DRFS between the Chemo and Endocrine Therapy arm and the Endocrine Therapy Alone arm, a Cox model was used with adjustment for the continuous recurrence score.|This analysis includes only postmenopausal participants.||1.37|0.81|0.70
72578359|NCT04856930|144684141|SUPERIORITY||Least Square (LS) Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|1.25||0.7841|TWO_SIDED|90.0|-2.42|1.73||LS Mean, Standard error, 90% CI, p-value based on LRMM which included: treatment, visit, treatment by visit interaction, and Hurley Stage at baseline (II vs. III) as categorical covariates; baseline AN count as continuous covariate.|Linear repeated measures model (LRMM)|||||1.73|-2.42|0.7841
72578360|NCT04856930|144684141|SUPERIORITY||LS Mean Difference|1.3|STANDARD_ERROR_OF_MEAN|1.25||0.2885|TWO_SIDED|90.0|-0.74|3.4||LS Mean, Standard error, 90% CI, p-value based on LRMM which included: treatment, visit, treatment by visit interaction, and Hurley Stage at baseline (II vs. III) as categorical covariates; baseline AN count as continuous covariate.|LRMM|||||3.40|-0.74|0.2885
72578361|NCT04856930|144684142|SUPERIORITY||LS Mean Difference|-4.8|STANDARD_ERROR_OF_MEAN|8.97||0.5939|TWO_SIDED|90.0|-19.66|10.07||LS Mean, Standard error, 90% CI, p-value based on LRMM which included: treatment, visit, treatment by visit interaction, and Hurley Stage at baseline (II vs. III) as categorical covariates; baseline AN count as continuous covariate.|LRMM|||||10.07|-19.66|0.5939
72578362|NCT04856930|144684142|SUPERIORITY||LS Mean Difference|3.5|STANDARD_ERROR_OF_MEAN|8.95||0.7002|TWO_SIDED|90.0|-11.38|18.29||LS Mean, Standard error, 90% CI, p-value based on LRMM which included: treatment, visit, treatment by visit interaction, and Hurley Stage at baseline (II vs. III) as categorical covariates; baseline AN count as continuous covariate.|LRMM|||||18.29|-11.38|0.7002
72578363|NCT04856930|144684143|SUPERIORITY||Risk Difference (RD)|5.3|||||TWO_SIDED|90.0|-13.3|23.4|||||Estimate parameter and 90% CI was based on Unadjusted Risk Difference and exact unconditional confidence intervals (CI).|||23.4|-13.3|
72578364|NCT04856930|144684143|SUPERIORITY||Risk Difference (RD)|3.3|||||TWO_SIDED|90.0|-14.6|21.0|||||Estimate parameter and 90% C was based on Unadjusted Risk Difference and exact unconditional CIs.|||21.0|-14.6|
72578365|NCT04856930|144684144|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.54||0.7282|TWO_SIDED|90.0|-1.08|0.7||LS Mean, Standard error, 90% CI, p-value based on LRMM which included: treatment, visit, treatment by visit interaction, and Hurley Stage at baseline (II vs. III) as categorical covariates and baseline worst HS Pain NRS as a continuous covariate.|LRMM|||||0.70|-1.08|0.7282
72578366|NCT04856930|144684144|SUPERIORITY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.54||0.5019|TWO_SIDED|90.0|-1.25|0.53||LS Mean, Standard error, 90% CI, p-value based on LRMM which included: treatment, visit, treatment by visit interaction, and Hurley Stage at baseline (II vs. III) as categorical covariates and baseline worst HS Pain NRS as a continuous covariate.|LRMM|||||0.53|-1.25|0.5019
72578367|NCT04856930|144684145|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.49||0.7698|TWO_SIDED|90.0|-0.96|0.67||LS Mean, Standard error, 90% CI, p-value based on LRMM which included: treatment, visit, treatment by visit interaction, and Hurley Stage at baseline (II vs. III) as categorical covariates and baseline average HS Pain NRS as a continuous covariate.|LRMM|||||0.67|-0.96|0.7698
72578368|NCT04856930|144684145|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.49||0.7468|TWO_SIDED|90.0|-0.97|0.65||LS Mean, Standard error, 90% CI, p-value based on LRMM which included: treatment, visit, treatment by visit interaction, and Hurley Stage at baseline (II vs. III) as categorical covariates and baseline average HS Pain NRS as a continuous covariate.|LRMM|||||0.65|-0.97|0.7468
72578369|NCT04856930|144684146|SUPERIORITY||LS Mean Difference|-25.7|STANDARD_ERROR_OF_MEAN|23.46||0.275|TWO_SIDED|90.0|-64.57|13.14||LS Mean, Standard error, 90% CI, p-value based on LRMM which included: treatment, visit, treatment by visit interaction, and Hurley Stage at baseline (II vs. III) as categorical covariates and baseline worst HS Pain NRS as a continuous covariate.|LRMM|||||13.14|-64.57|0.2750
72578370|NCT04856930|144684146|SUPERIORITY||LS Mean Difference|-21.2|STANDARD_ERROR_OF_MEAN|23.81||0.3757|TWO_SIDED|90.0|-60.6|18.28||LS Mean, Standard error, 90% CI, p-value based on LRMM which included: treatment, visit, treatment by visit interaction, and Hurley Stage at baseline (II vs. III) as categorical covariates and baseline worst HS Pain NRS as a continuous covariate.|LRMM|||||18.28|-60.60|0.3757
72578371|NCT04856930|144684147|SUPERIORITY||LS Mean Difference|-6.6|STANDARD_ERROR_OF_MEAN|13.04||0.6146|TWO_SIDED|90.0|-28.22|15.05||LS Mean, Standard error, 90% CI, p-value based on LRMM which included: treatment, visit, treatment by visit interaction, and Hurley Stage at baseline (II vs. III) as categorical covariates and baseline average HS Pain NRS as a continuous covariate.|LRMM|||||15.05|-28.22|0.6146
72411221|NCT03893448|144330631|SUPERIORITY||GMC Ratio (V114 / Prevnar 13™)|92.03|||<|0.001|TWO_SIDED|95.0|83.47|101.47|||t-test, 1 sided||V114/Prevnar 13™|Serotype 22F GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||101.47|83.47|< 0.001
72578372|NCT04856930|144684147|SUPERIORITY||LS Mean Difference|-8.9|STANDARD_ERROR_OF_MEAN|12.95||0.4951|TWO_SIDED|90.0|-30.35|12.62||LS Mean, Standard error, 90% CI, p-value based on LRMM which included: treatment, visit, treatment by visit interaction, and Hurley Stage at baseline (II vs. III) as categorical covariates and baseline average HS Pain NRS as a continuous covariate.|LRMM|||||12.62|-30.35|0.4951
72578373|NCT03022084|144684211|NON_INFERIORITY|The probability that Desyncra is non-inferior to CBT, defined by the sponsor as the event that mean TQ score change from baseline in the Desyncra arm is no more than 3.5 points worse than the mean TQ change in the CBT arm.|||||||||||||Bayesian|Data collected to date were analyzed using a Bayesian approach.|||Data collected to date were analyzed using a Bayesian approach.|||
72578374|NCT03104400|144684237|SUPERIORITY|The overall type I error rate of the primary and the 14 ranked secondary endpoints was controlled using a two-part sequential graphical multiple testing procedure starting with the primary endpoint using α/2 for each dose followed by a prespecified α transfer path.|Response Rate Difference|34.5|||<|0.0001|TWO_SIDED|95.0|28.2|40.7|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted for the main stratification factor of current DMARD use (yes/no).|Response Rate Difference = Upadacitinib - Placebo|||40.7|28.2|<0.0001
72578375|NCT03104400|144684237|SUPERIORITY|The overall type I error rate of the primary and the 14 ranked secondary endpoints was controlled using a two-part sequential graphical multiple testing procedure starting with the primary endpoint using α/2 for each dose followed by a prespecified α transfer path.|Response Rate Difference|42.3|||<|0.0001|TWO_SIDED|95.0|36.3|48.3|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted for the main stratification factor of current DMARD use (yes/no).|Response Rate Difference = Upadacitinib - Placebo|||48.3|36.3|<0.0001
72578376|NCT03104400|144684238|SUPERIORITY|The overall type I error rate of the primary and the 14 ranked secondary endpoints was controlled using a two-part sequential graphical multiple testing procedure starting with the primary endpoint using α/2 for each dose followed by a prespecified α transfer path.|Least Squares (LS) Mean Difference|-0.28|||<|0.0001|TWO_SIDED|95.0|-0.35|-0.22|||Mixed Effect Model Repeated Measurement|MMRM analysis including treatment, visit, treatment-by-visit interaction, current DMARD use (yes/no) as fixed factors and Baseline value as covariate.|Treatment Difference = Upadacitinib - Placebo|||-0.22|-0.35|<0.0001
72578377|NCT03104400|144684238|SUPERIORITY|The overall type I error rate of the primary and the 14 ranked secondary endpoints was controlled using a two-part sequential graphical multiple testing procedure starting with the primary endpoint using α/2 for each dose followed by a prespecified α transfer path.|LS Mean Difference|-0.34|||<|0.0001|TWO_SIDED|95.0|-0.4|-0.27|||Mixed Effect Model Repeated Measurement|MMRM analysis including treatment, visit, treatment-by-visit interaction, current DMARD use (yes/no) as fixed factors and Baseline value as covariate.|Treatment Difference = Upadacitinib - Placebo|||-0.27|-0.40|<0.0001
72578378|NCT03104400|144684239|SUPERIORITY|The overall type I error rate of the primary and the 14 ranked secondary endpoints was controlled using a two-part sequential graphical multiple testing procedure starting with the primary endpoint using α/2 for each dose followed by a prespecified α transfer path.|Response Rate Difference|31.1|||<|0.0001|TWO_SIDED|95.0|24.7|37.5|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusting for the main stratification factor of current DMARD use (yes/no).|Response Rate Difference = Upadacitinib - Placebo|||37.5|24.7|<0.0001
72578379|NCT03104400|144684239|SUPERIORITY|The overall type I error rate of the primary and the 14 ranked secondary endpoints was controlled using a two-part sequential graphical multiple testing procedure starting with the primary endpoint using α/2 for each dose followed by a prespecified α transfer path.|Response Rate Difference|43.1|||<|0.0001|TWO_SIDED|95.0|36.7|49.6|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusting for the main stratification factor of current DMARD use (yes/no).|Response Rate Difference = Upadacitinib - Placebo|||49.6|36.7|<0.0001
72578380|NCT03104400|144684240|SUPERIORITY|The overall type I error rate of the primary and the 14 ranked secondary endpoints was controlled using a two-part sequential graphical multiple testing procedure starting with the primary endpoint using α/2 for each dose followed by a prespecified α transfer path.|Response Rate Difference|41.3|||<|0.0001|TWO_SIDED|95.0|32.8|49.8|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusting for the main stratification factor of current DMARD use (yes/no).|Response Rate Difference = Upadacitinib - Placebo|||49.8|32.8|<0.0001
72578381|NCT03104400|144684240|SUPERIORITY|The overall type I error rate of the primary and the 14 ranked secondary endpoints was controlled using a two-part sequential graphical multiple testing procedure starting with the primary endpoint using α/2 for each dose followed by a prespecified α transfer path.|Response Rate Difference|41.1|||<|0.0001|TWO_SIDED|95.0|32.5|49.6|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted for the main stratification factor of current DMARD use (yes/no).|Response Rate Difference = Upadacitinib - Placebo|||49.6|32.5|<0.0001
72578382|NCT03104400|144684241|SUPERIORITY|The overall type I error rate of the primary and the 14 ranked secondary endpoints was controlled using a two-part sequential graphical multiple testing procedure starting with the primary endpoint using α/2 for each dose followed by a prespecified α transfer path.|LS Mean Difference|-0.29||||0.0002|TWO_SIDED|95.0|-0.44|-0.14|||ANCOVA|ANCOVA model including treatment and the stratification factor current DMARD use (yes/no) as fixed factors and Baseline value as covariate.|Treatment Difference = Upadacitinib - Placebo|||-0.14|-0.44|0.0002
72578383|NCT03104400|144684241|SUPERIORITY|The overall type I error rate of the primary and the 14 ranked secondary endpoints was controlled using a two-part sequential graphical multiple testing procedure starting with the primary endpoint using α/2 for each dose followed by a prespecified α transfer path.|LS Mean Difference|-0.21||||0.0069|TWO_SIDED|95.0|-0.36|-0.06|||ANCOVA|ANCOVA model including treatment and the stratification factor current DMARD use (yes/no) as fixed factors and Baseline value as covariate.|Treatment Difference = Upadacitinib - Placebo|||-0.06|-0.36|0.0069
72578384|NCT03104400|144684242|SUPERIORITY|The overall type I error rate of the primary and the 14 ranked secondary endpoints was controlled using a two-part sequential graphical multiple testing procedure starting with the primary endpoint using α/2 for each dose followed by a prespecified α transfer path.|Response Rate Difference|24.3|||<|0.0001|TWO_SIDED|95.0|18.8|29.8||Cochran-Mantel-Haenszel (CMH) test adjusted for the main stratification factor of current DMARD use (yes/no).|Cochran-Mantel-Haenszel||Response Rate Difference = Upadacitinib - Placebo|||29.8|18.8|<0.0001
72578385|NCT03104400|144684242|SUPERIORITY|The overall type I error rate of the primary and the 14 ranked secondary endpoints was controlled using a two-part sequential graphical multiple testing procedure starting with the primary endpoint using α/2 for each dose followed by a prespecified α transfer path.|Response Rate Difference|33.1|||<|0.0001|TWO_SIDED|95.0|27.4|38.8|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted for the main stratification factor of current DMARD use (yes/no).|Response Rate Difference = Upadacitinib - Placebo|||38.8|27.4|<0.0001
72578386|NCT03104400|144684243|SUPERIORITY|The overall type I error rate of the primary and the 14 ranked secondary endpoints was controlled using a two-part sequential graphical multiple testing procedure starting with the primary endpoint using α/2 for each dose followed by a prespecified α transfer path.|Response Rate Difference|21.3|||<|0.0001|TWO_SIDED|95.0|13.0|29.7|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted for the main stratification factor of current DMARD use (yes/no).|Response Rate Difference = Upadacitinib - Placebo|||29.7|13.0|<0.0001
72329480|NCT03037476|144184391|OTHER|General Linear Model|Slope|-0.1604|||<|0.001|TWO_SIDED|95.0|-0.2525|-0.0683|||Mixed Models Analysis|Negative Binomial Regression||Change in perceived norm (in perceived days of use in past year) at 6 month follow up||-0.0683|-0.2525|<0.001
72411222|NCT03893448|144330631|SUPERIORITY||GMC Ratio (V114 / Prevnar 13™)|29.5|||<|0.001|TWO_SIDED|95.0|26.16|33.26|||t-test, 1 sided||V114/Prevnar 13™|Serotype 33F GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||33.26|26.16|< 0.001
72578387|NCT03104400|144684243|SUPERIORITY|The overall type I error rate of the primary and the 14 ranked secondary endpoints was controlled using a two-part sequential graphical multiple testing procedure starting with the primary endpoint using α/2 for each dose followed by a prespecified α transfer path.|Response Rate Difference|25.3|||<|0.0001|TWO_SIDED|95.0|16.9|33.7|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted for the main stratification factor of current DMARD use (yes/no).|Response Rate Difference = Upadacitinib - Placebo|||33.7|16.9|<0.0001
72578388|NCT03104400|144684244|NON_INFERIORITY|"Non-inferiority of each upadacitinib dose versus adalimumab was assessed using Koch's 3-arm approach; non-inferiority was achieved if upadacitinib preserved at least 50% of the placebo-subtracted adalimumab effect.~The overall type I error rate of the primary and the 14 ranked secondary endpoints was controlled using a two-part sequential graphical multiple testing procedure starting with the primary endpoint using α/2 for each dose followed by a prespecified α transfer path."|Percent Adalimumab Effect Preservation|119.381|||<|0.0001|TWO_SIDED|95.0|97.987|147.942|||Koch 3-Arm Test||The percent of adalimumab effect preservation is the point estimate of 3-arm non-inferiority analysis, which is calculated by (Upadacitinib - Placebo) / (Adalimumab - Placebo) \* 100.|||147.942|97.987|<0.0001
72578389|NCT03104400|144684244|NON_INFERIORITY|"Non-inferiority of each upadacitinib dose versus adalimumab was assessed using Koch's 3-arm approach; non-inferiority was achieved if upadacitinib preserved at least 50% of the placebo-subtracted adalimumab effect.~The overall type I error rate of the primary and the 14 ranked secondary endpoints was controlled using a two-part sequential graphical multiple testing procedure starting with the primary endpoint using α/2 for each dose followed by a prespecified α transfer path."|Percent Adalimumab Effect Preservation|146.604|||<|0.0001|TWO_SIDED|95.0|122.817|180.398|||Koch 3-Arm Test||The percent of adalimumab effect preservation is the point estimate of 3-arm non-inferiority analysis, which is calculated by (Upadacitinib - Placebo) / (Adalimumab - Placebo) \* 100.|||180.398|122.817|<0.0001
72578390|NCT03104400|144684245|SUPERIORITY|The overall type I error rate of the primary and the 14 ranked secondary endpoints was controlled using a two-part sequential graphical multiple testing procedure starting with the primary endpoint using α/2 for each dose followed by a prespecified α transfer path.|LS Mean Difference|4.67|||<|0.0001|TWO_SIDED|95.0|3.67|5.67|||Mixed Effect Model Repeated Measurement|MMRM analysis including treatment, visit, treatment-by-visit interaction, current DMARD use (yes/no) as fixed factors and Baseline value as covariate.|Treatment Difference = Upadacitinib - Placebo|||5.67|3.67|<0.0001
72578391|NCT03104400|144684245|SUPERIORITY|The overall type I error rate of the primary and the 14 ranked secondary endpoints was controlled using a two-part sequential graphical multiple testing procedure starting with the primary endpoint using α/2 for each dose followed by a prespecified α transfer path.|LS Mean Difference|5.72|||<|0.0001|TWO_SIDED|95.0|4.71|6.72|||Mixed Effect Model Repeated Measurement|MMRM analysis including treatment, visit, treatment-by-visit interaction, current DMARD use (yes/no) as fixed factors and Baseline value as covariate.|Treatment Difference = Upadacitinib - Placebo|||6.72|4.71|<0.0001
72578392|NCT03104400|144684246|SUPERIORITY|The overall type I error rate of the primary and the 14 ranked secondary endpoints was controlled using a two-part sequential graphical multiple testing procedure starting with the primary endpoint using α/2 for each dose followed by a prespecified α transfer path.|LS Mean Difference|3.5|||<|0.0001|TWO_SIDED|95.0|2.4|4.7|||Mixed Effect Model Repeated Measurement|MMRM analysis including treatment, visit, treatment-by-visit interaction, current DMARD use (yes/no) as fixed factors and Baseline value as covariate.|Treatment Difference = Upadacitinib - Placebo|||4.7|2.4|<0.0001
72578393|NCT03104400|144684246|SUPERIORITY|The overall type I error rate of the primary and the 14 ranked secondary endpoints was controlled using a two-part sequential graphical multiple testing procedure starting with the primary endpoint using α/2 for each dose followed by a prespecified α transfer path.|LS Mean Difference|4.3|||<|0.0001|TWO_SIDED|95.0|3.1|5.5|||Mixed Effect Model Repeated Measurement|MMRM analysis including treatment, visit, treatment-by-visit interaction, current DMARD use (yes/no) as fixed factors and Baseline value as covariate.|Treatment Difference = Upadacitinib - Placebo|||5.5|3.1|<0.0001
72578394|NCT03104400|144684247|SUPERIORITY|The overall type I error rate of the primary and the 14 ranked secondary endpoints was controlled using a two-part sequential graphical multiple testing procedure starting with the primary endpoint using α/2 for each dose followed by a prespecified α transfer path.|Response Rate Difference|5.6||||0.0815|TWO_SIDED|95.0|-0.6|11.8|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusting for the main stratification factor of current DMARD use (yes/no).|Response Rate Difference = Upadacitinib - Adalimumab|||11.8|-0.6|0.0815
72578395|NCT03104400|144684247|SUPERIORITY|The overall type I error rate of the primary and the 14 ranked secondary endpoints was controlled using a two-part sequential graphical multiple testing procedure starting with the primary endpoint using α/2 for each dose followed by a prespecified α transfer path.|LS Mean Difference|13.5|||<|0.0001|TWO_SIDED|95.0|7.5|19.4|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted for the main stratification factor of current DMARD use (yes/no).|Response Rate Difference = Upadacitinib - Adalimumab|||19.4|7.5|<0.0001
72578396|NCT03104400|144684248|OTHER|The overall type I error rate of the primary and the 14 ranked secondary endpoints was controlled using a two-part sequential graphical multiple testing procedure starting with the primary endpoint using α/2 for each dose followed by a prespecified α transfer path.|Response Rate Difference|36.8|||<|0.0001|TWO_SIDED|95.0|25.7|47.9||This comparison was not tested for statistical significance because the hierarchical testing procedures stopped at ACR 20 at Week 12 superiority test of upadacitinib 15 mg versus adalimumab 40 mg.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusting for the main stratification factor of current DMARD use (yes/no).|Response Rate Difference = Upadacitinib - Placebo|||47.9|25.7|<0.0001
72411223|NCT03893448|144330632|SUPERIORITY||Percentage Point Difference|95.1|||<|0.001|TWO_SIDED|95.0|93.1|96.5||p-value is 1-sided|Miettinen & Nurminen||V114-Prevnar 13™|Serotype 22F Estimated difference, CI, and p-value are based on the Miettinen \& Nurminen method.||96.5|93.1|< 0.001
72411224|NCT03893448|144330632|SUPERIORITY||Percentage Point Difference|85.2|||<|0.001|TWO_SIDED|95.0|82.3|87.7||p-value is 1-sided|Miettinen & Nurminen||V114-Prevnar 13™|Serotype 33F Estimated difference, CI, and p-value are based on the Miettinen \& Nurminen method.||87.7|82.3|< 0.001
72411225|NCT03893448|144330633|SUPERIORITY||GMC Ratio (V114 / Prevnar 13™)|68.8|||<|0.001|TWO_SIDED|95.0|63.1|75.02|||t-test, 1 sided||V114/Prevnar 13™|Serotype 22F GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||75.02|63.10|< 0.001
72543659|NCT00433381|144617223|OTHER|||||||||||||||||Null hypothesis: 35% discontinuation rate of bevacizumab and temozolomide. Alternative hypothesis: 5%. Type I and II error rates = 0.10. Sample size = 29.|The determination of treatment tolerability was to be made based on the following rules: If 6 or fewer of the cases (6/29=20.6%) stop treatment due to medical conditions, then reject the null hypothesis that the discontinuation rate is at least 35% and conclude tolerability. If 7 or more of the cases (7/29=24.1%) stop treatment due to medical conditions, then reject the alternative hypothesis that the discontinuation rate no more than 15%.|||
72543660|NCT00433381|144617224|OTHER|Receiver Operating Characteristic (ROC) analysis|Area Under the Curve (AUC)|0.5|||||TWO_SIDED|95.0|0.09|0.91||||||Accuracy estimate, as measured by the Area under the Curve (AUC), for the prediction of PFS-6 by change in metabolic ratio of tumor NAA/Cho at 2 weeks||0.91|0.09|
72543661|NCT00433381|144617224|OTHER|ROC analysis|Area Under the Curve (AUC)|0.54|||||TWO_SIDED|95.0|0.14|0.95||||||AUC (Accuracy) estimate for the prediction of PFS-6 by change in metabolic ratio of tumor Cho/Cr at 2 weeks||0.95|0.14|
72578397|NCT03104400|144684248|OTHER|The overall type I error rate of the primary and the 14 ranked secondary endpoints was controlled using a two-part sequential graphical multiple testing procedure starting with the primary endpoint using α/2 for each dose followed by a prespecified α transfer path.|Response Rate Difference|39.8|||<|0.0001|TWO_SIDED|95.0|28.8|50.9||This comparison was not tested for statistical significance because the hierarchical testing procedures stopped at ACR 20 at Week 12 superiority test of upadacitinib 15 mg versus adalimumab 40 mg.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted for the main stratification factor of current DMARD use (yes/no).|Response Rate Difference = Upadacitinib - Placebo|||50.9|28.8|<0.0001
72578398|NCT03104400|144684249|OTHER|The overall type I error rate of the primary and the 14 ranked secondary endpoints was controlled using a two-part sequential graphical multiple testing procedure starting with the primary endpoint using α/2 for each dose followed by a prespecified α transfer path.|LS Mean Difference|0.0||||0.897|TWO_SIDED|95.0|-0.3|0.3||This comparison was not tested for statistical significance because the hierarchical testing procedures stopped at ACR 20 at Week 12 superiority test of upadacitinib 15 mg versus adalimumab 40 mg.|Mixed Effect Model Repeated Measurement|MMRM analysis including treatment, visit, treatment-by-visit interaction, current DMARD use (yes/no) as fixed factors and Baseline value as covariate.|Treatment Difference = Upadacitinib - Adalimumab|||0.3|-0.3|0.8970
72578399|NCT03104400|144684249|OTHER|The overall type I error rate of the primary and the 14 ranked secondary endpoints was controlled using a two-part sequential graphical multiple testing procedure starting with the primary endpoint using α/2 for each dose followed by a prespecified α transfer path.|LS Mean Difference|-0.5||||0.0028|TWO_SIDED|95.0|-0.7|-0.2||This comparison was not tested for statistical significance because the hierarchical testing procedures stopped at ACR 20 at Week 12 superiority test of upadacitinib 15 mg versus adalimumab 40 mg.|Mixed Effect Model Repeated Measurement|MMRM analysis including treatment, visit, treatment-by-visit interaction, current DMARD use (yes/no) as fixed factors and Baseline value as covariate.|Treatment Difference = Upadacitinib - Adalimumab|||-0.2|-0.7|0.0028
72578400|NCT03104400|144684250|OTHER|The overall type I error rate of the primary and the 14 ranked secondary endpoints was controlled using a two-part sequential graphical multiple testing procedure starting with the primary endpoint using α/2 for each dose followed by a prespecified α transfer path.|LS Mean Difference|-0.08||||0.0162|TWO_SIDED|95.0|-0.15|-0.01||This comparison was not tested for statistical significance because the hierarchical testing procedures stopped at ACR 20 at Week 12 superiority test of upadacitinib 15 mg versus adalimumab 40 mg.|Mixed Effect Model Repeated Measurement|MMRM analysis including treatment, visit, treatment-by-visit interaction, current DMARD use (yes/no) as fixed factors and Baseline value as covariate.|Treatment Difference = Upadacitinib - Adalimumab|||-0.01|-0.15|0.0162
72578401|NCT03104400|144684250|OTHER|The overall type I error rate of the primary and the 14 ranked secondary endpoints was controlled using a two-part sequential graphical multiple testing procedure starting with the primary endpoint using α/2 for each dose followed by a prespecified α transfer path.|LS Mean Difference|-0.14|||<|0.0001|TWO_SIDED|95.0|-0.2|-0.07||This comparison was not tested for statistical significance because the hierarchical testing procedures stopped at ACR 20 at Week 12 superiority test of upadacitinib 15 mg versus adalimumab 40 mg.|Mixed Effect Model Repeated Measurement|MMRM analysis including treatment, visit, treatment-by-visit interaction, current DMARD use (yes/no) as fixed factors and Baseline value as covariate.|Treatment Difference = Upadacitinib - Adalimumab|||-0.07|-0.20|<0.0001
72578402|NCT03104400|144684251|OTHER|The overall type I error rate of the primary and the 14 ranked secondary endpoints was controlled using a two-part sequential graphical multiple testing procedure starting with the primary endpoint using α/2 for each dose followed by a prespecified α transfer path.|LS Mean Difference|-17.1|||<|0.0001|TWO_SIDED|95.0|-19.6|-14.6||This comparison was not tested for statistical significance because the hierarchical testing procedures stopped at ACR 20 at Week 12 superiority test of upadacitinib 15 mg versus adalimumab 40 mg.|Mixed Effect Model Repeated Measurement|MMRM analysis including treatment, visit, treatment-by-visit interaction, current DMARD use (yes/no) as fixed factors and Baseline value as covariate.|Treatment Difference = Upadacitinib - Placebo|||-14.6|-19.6|<0.0001
72543662|NCT00433381|144617224|OTHER|ROC analysis|Area Under the Curve (AUC)|0.46|||||TWO_SIDED|95.0|0.0|0.99||||||AUC (Accuracy) estimate for the prediction of PFS-6 by change in metabolic ratio of tumor NAA/Cr at 2 weeks||0.99|0|
72543663|NCT00433381|144617224|OTHER||Area Under the Curve (AUC)|0.85|||||TWO_SIDED|95.0|0.53|1.0||||||AUC (Accuracy) estimate for the prediction of PFS-6 by change in metabolic ratio of tumor NAA/Cho at 8 weeks||1|0.53|
72543664|NCT00433381|144617224|OTHER||Area Under the Curve (AUC)|0.83|||||TWO_SIDED|95.0|0.47|1.0||||||AUC (Accuracy) estimate for the prediction of PFS-6 by change in metabolic ratio of tumor Cho/Cr at 8 weeks||1|0.47|
72543665|NCT00433381|144617224|OTHER||Area Under the Curve (AUC)|0.6|||||TWO_SIDED|95.0|0.11|1.0||||||AUC (Accuracy) estimate for the prediction of PFS-6 by change in metabolic ratio of tumor NAA/Cr at 8 weeks||1|0.11|
72543666|NCT00433381|144617224|OTHER||Area Under the Curve (AUC)|0.75|||||TWO_SIDED|95.0|0.21|1.0||||||AUC (Accuracy) estimate for the prediction of PFS-6 by change in metabolic ratio of tumor NAA/Cho at 16 weeks||1|0.21|
72543667|NCT00433381|144617224|OTHER|ROC analysis|Area Under the Curve (AUC)|1.0|||||TWO_SIDED|95.0|1.0|1.0||||||AUC (Accuracy) estimate for the prediction of PFS-6 by change in metabolic ratio of tumor Cho/Cr at 16 weeks||1|1|
72543668|NCT00433381|144617224|OTHER|ROC analysis|Area Under the Curve (AUC)|0.46|||||TWO_SIDED|95.0|0.0|1.0||||||AUC (Accuracy) estimate for the prediction of PFS-6 by change in metabolic ratio of tumor NAA/Cr at 16 weeks||1|0|
72543669|NCT00433381|144617224|OTHER|ROC analysis|Area Under the Curve (AUC)|0.39|||||TWO_SIDED|95.0|0.0|0.88||||||AUC (Accuracy) estimate for the prediction of PFS-6 by change in metabolic ratio of periphery NAA/Cho at 2 weeks||0.88|0|
72543670|NCT00433381|144617224|OTHER|ROC analysis|Area Under the Curve (AUC)|0.52|||||TWO_SIDED|95.0|0.13|0.91||||||AUC (Accuracy) estimate for the prediction of PFS-6 by change in metabolic ratio of periphery Cho/Cr at 2 weeks||0.91|0.13|
72543671|NCT00433381|144617224|OTHER|ROC analysis|Area Under the Curve (AUC)|0.54|||||TWO_SIDED|95.0|0.06|1.0||||||AUC (Accuracy) estimate for the prediction of PFS-6 by change in metabolic ratio of periphery NAA/Cr at 2 weeks||1|0.06|
72543672|NCT00433381|144617224|OTHER|ROC analysis|Area Under the Curve (AUC)|0.47|||||TWO_SIDED|95.0|0.02|0.92||||||AUC (Accuracy) estimate for the prediction of PFS-6 by change in metabolic ratio of periphery NAA/Cho at 8 weeks||0.92|0.02|
72543673|NCT00433381|144617224|OTHER|ROC analysis|Area Under the Curve (AUC)|0.41|||||TWO_SIDED|95.0|0.01|0.8||||||AUC (Accuracy) estimate for the prediction of PFS-6 by change in metabolic ratio of periphery Cho/Cr at 8 weeks||0.80|0.01|
72543674|NCT00433381|144617224|OTHER|ROC analysis|Area Under the Curve (AUC)|0.63|||||TWO_SIDED|95.0|0.22|1.0||||||AUC (Accuracy) estimate for the prediction of PFS-6 by change in metabolic ratio of periphery NAA/Cr at 8 weeks||1|0.22|
72543675|NCT00433381|144617224|OTHER|ROC analysis|Area Under the Curve (AUC)|1.0|||||TWO_SIDED|95.0|1.0|1.0||||||AUC (Accuracy) estimate for the prediction of PFS-6 by change in metabolic ratio of periphery NAA/Cho at 16 weeks||1|1|
72543676|NCT00433381|144617224|OTHER|ROC analysis|Area Under the Curve (AUC)|1.0|||||TWO_SIDED|95.0|1.0|1.0||||||AUC (Accuracy) estimate for the prediction of PFS-6 by change in metabolic ratio of periphery Cho/Cr at 16 weeks||1|1|
72543677|NCT00433381|144617224|OTHER|ROC analysis|Area Under the Curve (AUC)|0.93|||||TWO_SIDED|95.0|0.73|1.0||||||AUC (Accuracy) estimate for the prediction of PFS-6 by change in metabolic ratio of periphery NAA/Cr at 16 weeks||1|0.73|
72543678|NCT00433381|144617225|OTHER|ROC analysis|Area Under the Curve (AUC)|0.42|||||TWO_SIDED|95.0|0.0|0.92||||||AUC (Accuracy) estimate for the prediction of 12 month overall survival by change in metabolic ratio of tumor NAA/Cho at 2 weeks||0.92|0|
72543679|NCT00433381|144617225|OTHER|ROC analysis|Area Under the Curve (AUC)|0.42|||||TWO_SIDED|95.0|0.0|0.88||||||AUC (Accuracy) estimate for the prediction of 12 month overall survival by change in metabolic ratio of tumor Cho/Cr at 2 weeks||0.88|0|
72543680|NCT00433381|144617225|OTHER|ROC analysis|Accuracy: Area Under the ROC|0.67|||||TWO_SIDED|95.0|0.25|1.0||||||AUC (Accuracy) estimate for the prediction of 12 month overall survival by change in metabolic ratio of tumor NAA/Cr at 2 weeks||1|0.25|
72543681|NCT00433381|144617225|OTHER|ROC analysis|Area Under the Curve (AUC)|0.8|||||TWO_SIDED|95.0|0.47|1.0||||||AUC (Accuracy) estimate for the prediction of 12 month overall survival by change in metabolic ratio of tumor NAA/Cho at 8 weeks||1|0.47|
72543682|NCT00433381|144617225|OTHER|ROC analysis|Area Under the Curve (AUC)|0.78|||||TWO_SIDED|95.0|0.44|1.0||||||AUC (Accuracy) estimate for the prediction of 12 month overall survival by change in metabolic ratio of tumor Cho/Cr at 8 weeks||1|0.44|
72543683|NCT00433381|144617225|OTHER|ROC analysis|Area Under the Curve (AUC)|0.6|||||TWO_SIDED|95.0|0.17|1.0||||||AUC (Accuracy) estimate for the prediction of 12 month overall survival by change in metabolic ratio of tumor NAA/Cr at 8 weeks||1|0.17|
72543684|NCT00433381|144617225|OTHER|ROC analysis|Area Under the Curve (AUC)|0.8|||||TWO_SIDED|95.0|0.45|1.0||||||AUC (Accuracy) estimate for the prediction of 12 month overall survival by change in metabolic ratio of tumor NAA/Cho at 16 weeks||1|0.45|
72543685|NCT00433381|144617225|OTHER|ROC analysis|Area Under the Curve (AUC)|0.73|||||TWO_SIDED|95.0|0.19|1.0||||||AUC (Accuracy) estimate for the prediction of 12 month overall survival by change in metabolic ratio of tumor Cho/Cr at 16 weeks||1|0.19|
72543686|NCT00433381|144617225|OTHER|ROC analysis|Area Under the Curve (AUC)|0.57|||||TWO_SIDED|95.0|0.03|1.0||||||AUC (Accuracy) estimate for the prediction of 12 month overall survival by change in metabolic ratio of tumor NAA/Cr at 16 weeks||1|0.03|
72543687|NCT00433381|144617225|OTHER|ROC analysis|Area Under the Curve (AUC)|0.6|||||TWO_SIDED|95.0|0.2|1.0||||||AUC (Accuracy) estimate for the prediction of 12 month overall survival by change in metabolic ratio of periphery NAA/Cho at 2 weeks||1|0.20|
72543688|NCT00433381|144617225|OTHER|ROC analysis|Area Under the Curve (AUC)|0.72|||||TWO_SIDED|95.0|0.36|1.0||||||AUC (Accuracy) estimate for the prediction of 12 month overall survival by change in metabolic ratio of periphery Cho/Cr at 2 weeks||1|0.36|
72543689|NCT00433381|144617225|OTHER|ROC analysis|Area Under the Curve (AUC)|0.5|||||TWO_SIDED|95.0|0.06|0.94||||||AUC (Accuracy) estimate for the prediction of 12 month overall survival by change in metabolic ratio of periphery NAA/Cr at 2 weeks||0.94|0.06|
72543690|NCT00433381|144617225|OTHER|ROC analysis|Area Under the Curve (AUC)|0.58|||||TWO_SIDED|95.0|0.22|0.95||||||AUC (Accuracy) estimate for the prediction of 12 month overall survival by change in metabolic ratio of periphery NAA/Cho at 8 weeks||0.95|0.22|
72411226|NCT03893448|144330633|SUPERIORITY||GMC Ratio (V114 / Prevnar 13™)|44.91|||<|0.001|TWO_SIDED|95.0|41.04|49.14|||t-test, 1 sided||V114/Prevnar 13™|Serotype 33F GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||49.14|41.04|< 0.001
72411227|NCT03893448|144330636|SUPERIORITY||Percentage Point Difference|15.6|||<|0.001|TWO_SIDED|95.0|12.1|19.2||p-value is 1-sided|Miettinen & Nurminen||V114-Prevnar 13™|Estimated difference, CI, and p-value are based on the Miettinen \& Nurminen method||19.2|12.1|< 0.001
72411228|NCT03893448|144330637|SUPERIORITY||GMC Ratio (V114 / Prevnar 13™)|1.73|||<|0.001|TWO_SIDED|95.0|1.61|1.87|||t-test, 1 sided||V114/Prevnar 13™|GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||1.87|1.61|< 0.001
72411229|NCT03893448|144330638|SUPERIORITY||GMC Ratio (V114 / Prevnar 13™)|1.35|||<|0.001|TWO_SIDED|95.0|1.25|1.46|||t-test, 1 sided||V114/Prevnar 13™|GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||1.46|1.25|< 0.001
72543691|NCT00433381|144617225|OTHER|ROC analysis|Area Under the Curve (AUC)|0.5|||||TWO_SIDED|95.0|0.13|0.87||||||AUC (Accuracy) estimate for the prediction of 12 month overall survival by change in metabolic ratio of periphery Cho/Cr at 8 weeks||0.87|0.13|
72543692|NCT00433381|144617225|OTHER|ROC analysis|Area Under the Curve (AUC)|0.78|||||TWO_SIDED|95.0|0.47|1.0||||||AUC (Accuracy) estimate for the prediction of 12 month overall survival by change in metabolic ratio of periphery NAA/Cr at 8 weeks||1|0.47|
72543693|NCT00433381|144617225|OTHER|ROC analysis|Area Under the Curve (AUC)|1.0|||||TWO_SIDED|95.0|1.0|1.0||||||AUC (Accuracy) estimate for the prediction of 12 month overall survival by change in metabolic ratio of periphery NAA/Cho at 16 weeks||1|1|
72543694|NCT00433381|144617225|OTHER|ROC analysis|Area Under the Curve (AUC)|0.89|||||TWO_SIDED|95.0|0.63|1.0||||||AUC (Accuracy) estimate for the prediction of 12 month overall survival by change in metabolic ratio of periphery Cho/Cr at 16 weeks||1|0.63|
72543695|NCT00433381|144617225|OTHER|ROC analysis|Area Under the Curve (AUC)|1.0|||||TWO_SIDED|95.0|1.0|1.0||||||AUC (Accuracy) estimate for the prediction of 12 month overall survival by change in metabolic ratio of periphery NAA/Cr at 16 weeks||1|1|
72543696|NCT00433381|144617226|OTHER||||||||||||||||||The determination of treatment efficacy was to be made made based on the following rules: If 16 or more of the cases (16/57=28.1%) are progression free and alive at 6 months, then reject the null hypothesis that the rate is no better than 20%. If 15 or fewer of the cases (15/57=26.3%) are progression free and alive at 6 months, then reject the alternative hypothesis that the rate is at least 35%.|||
72543697|NCT00433381|144617228|OTHER|Agreement was assessed using a Kappa statistic|Kappa Statistic|0.39|||||TWO_SIDED|95.0|0.21|0.57||||||Agreement between Local and Central determinations 6-month PFS, based on imaging, was evaluated using Kappa statistics||0.57|0.21|
72329481|NCT03037476|144184391|OTHER|General Linear Model|Slope|-0.1441|||<|0.003|TWO_SIDED|95.0|-0.2404|-0.0478|||Mixed Models Analysis|Negative Binomial Regression||Change in perceived norm (perceived number of days of use in past year) at 12 month follow up||-0.0478|-0.2404|<.003
72411230|NCT01070810|144330650|SUPERIORITY|||||||0.4|||||||Wilcoxon (Mann-Whitney)|||||||0.40
72543698|NCT00433381|144617229|OTHER|Sensitivity|Sensitivity|0.6|||||TWO_SIDED|95.0|0.46|0.73||||||Sensitivity||0.73|0.46|
72543699|NCT00433381|144617229|OTHER|Specificity|Specificity|0.78|||||TWO_SIDED|95.0|0.66|0.87||||||Specificity||0.87|0.66|
72543700|NCT01084005|144617247|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.64|STANDARD_ERROR_OF_MEAN|0.08|<|0.0001||95.0|-0.81|-0.48|||ANCOVA|||||-0.48|-0.81|<0.0001
72543701|NCT01084005|144617248|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.35|STANDARD_ERROR_OF_MEAN|0.05|<|0.0001||95.0|-0.45|-0.24|||ANCOVA|||||-0.24|-0.45|<0.0001
72543702|NCT01084005|144617249|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.57|STANDARD_ERROR_OF_MEAN|0.07|<|0.0001||95.0|-0.71|-0.43|||ANCOVA|||||-0.43|-0.71|<0.0001
72543703|NCT01084005|144617250|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.62|STANDARD_ERROR_OF_MEAN|0.08|<|0.0001||95.0|-0.77|-0.47|||ANCOVA|||||-0.47|-0.77|<0.0001
72543704|NCT01084005|144617251|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-20.7|STANDARD_ERROR_OF_MEAN|4.8|<|0.0001||95.0|-30.2|-11.2|||ANCOVA|||||-11.2|-30.2|<0.0001
72543705|NCT01084005|144617252|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-18.6|STANDARD_ERROR_OF_MEAN|3.1|<|0.0001||95.0|-24.7|-12.6|||Mixed Models Analysis|||||-12.6|-24.7|<0.0001
72543706|NCT01084005|144617253|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-21.5|STANDARD_ERROR_OF_MEAN|3.4|<|0.0001||95.0|-28.1|-14.8|||Mixed Models Analysis|||||-14.8|-28.1|<0.0001
72543707|NCT01084005|144617254|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-21.6|STANDARD_ERROR_OF_MEAN|4.2|<|0.0001||95.0|-29.8|-13.4|||Mixed Models Analysis|||||-13.4|-29.8|<0.0001
72543708|NCT01084005|144617255|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|8.319|||<|0.0001||95.0|3.321|20.837|||Regression, Logistic|||||20.837|3.321|<0.0001
72543709|NCT01084005|144617258|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.214||||0.0048|TWO_SIDED|95.0|0.073|0.625|||Regression, Logistic|||Lina 5 mg qd vs Placebo||0.625|0.073|0.0048
72543710|NCT00549198|144617259|SUPERIORITY_OR_OTHER|||||||0.435||95.0||||The model includes the following covariates: treatment, visit, baseline GFR by MDRD, baseline BMI, race group, treatment\*visit, baseline GFR by MDRD\*visit and baseline BMI\*visit.|Mixed Models Analysis|The correlation matrix for within-subject errors is unstructured.||||||0.435
72543711|NCT00549198|144617260|SUPERIORITY_OR_OTHER|||||||0.057||95.0||||The model includes the following covariates: treatment, visit, baseline GFR by MDRD, baseline BMI, race group, age group, treatment\*visit, baseline GFR by MDRD\*visit and baseline BMI\*visit.|Mixed Models Analysis|The correlation matrix for within-subject errors is unstructured.||||||0.057
72543712|NCT00549198|144617261|SUPERIORITY_OR_OTHER|||||||0.06||95.0||||The model includes the following covariates: treatment, visit, baseline GFR by MDRD, baseline BMI, race group, treatment\*visit, baseline GFR by MDRD\*visit and baseline BMI\*visit.|Mixed Models Analysis|The correlation matrix for within-subject errors is unstructured.||||||0.060
72543713|NCT00549198|144617262|SUPERIORITY_OR_OTHER|||||||0.186||95.0||||The model includes the following covariates: treatment, visit, baseline GFR by CG, baseline BMI, race group, age group, hypertension, treatment\*visit, baseline GFR by CG\*visit and baseline BMI\*visit.|Mixed Models Analysis|The correlation matrix for within-subject errors is unstructured.||||||0.186
72543714|NCT00549198|144617263|SUPERIORITY_OR_OTHER|||||||0.413||95.0||||The model includes the following covariates: treatment, visit, baseline GFR by CG, baseline BMI, race group, age group, hypertension, treatment\*visit, baseline GFR by CG\*visit and baseline BMI\*visit.|Mixed Models Analysis|The correlation matrix for within-subject errors is unstructured.||||||0.413
72543715|NCT00549198|144617264|SUPERIORITY_OR_OTHER|||||||0.315||95.0||||The model includes the following covariates: treatment, visit, baseline GFR by CG, baseline BMI, race group, baseline CD4, treatment\*visit, baseline GFR by CG\*visit, baseline BMI\*visit and baseline CD4\*visit.|Mixed Models Analysis|The correlation matrix for within-subject errors is unstructured.||||||0.315
72543716|NCT00549198|144617271|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The model includes the following covariates: treatment, visit, baseline spine BMD, baseline BMI, race group, age group, hypertension, treatment\*visit, baseline spine BMD\*visit and baseline BMI\*visit.|Mixed Models Analysis|The correlation matrix for within-subject errors is unstructured.||||||<0.001
72543717|NCT00549198|144617272|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The model includes the following covariates: treatment, visit, baseline hip BMD, baseline BMI, race group, risk factor, country group, treatment\*visit, baseline hip BMD\*visit and baseline BMI\*visit.|Mixed Models Analysis|The correlation matrix for within-subject errors is unstructured.||||||<0.001
72543718|NCT00549198|144617273|SUPERIORITY_OR_OTHER|||||||0.036||95.0||||The model includes the following covariates: treatment, visit, baseline spine BMD, baseline BMI, race group, age group, treatment\*visit, baseline spine BMD\*visit and baseline BMI\*visit.|Mixed Models Analysis|The correlation matrix for within-subject errors is unstructured.||||||0.036
72543719|NCT00549198|144617274|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The model includes the following covariates: treatment, visit, baseline hip BMD, baseline BMI, race group, risk factor, prohibited medication, previous fracture, treatment\*visit, baseline hip BMD\*visit and baseline BMI\*visit.|Mixed Models Analysis|Correlation matrix for within-subject errors is unstructured.||||||<0.001
72543720|NCT00549198|144617275|SUPERIORITY_OR_OTHER|||||||0.112||95.0||||The model includes the following covariates: treatment, visit, baseline spine BMD, baseline BMI, race group, age group, treatment\*visit, baseline spine BMD\*visit and baseline BMI\*visit.|Mixed Models Analysis|correlation matrix for within-subject errors is unstructured.||||||0.112
72543721|NCT00549198|144617276|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The model includes the following covariates: treatment, visit, baseline hip BMD, baseline BMI, race group, risk factor, prohibited medication, previous fracture, treatment\*visit, baseline hip BMD\*visit, and baseline BMI\*visit.|Mixed Models Analysis|The correlation matrix for within-subject errors is unstructured.||||||<0.001
72543722|NCT00549198|144617309|SUPERIORITY_OR_OTHER|||||||0.3025||95.0||||The model includes the following covariates: treatment, age, baseline biomarker value, and gender.|ANOVA|Estimates are calculated from an ANOVA model. Parameters are analyzed based on log transformed data.||||||0.3025
72543723|NCT00549198|144617310|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||The model includes the following covariates: treatment, age, baseline biomarker value, baseline CD4, and gender.|ANOVA|Estimates are calculated from an ANOVA model. Parameters are analyzed based on log transformed data.||||||<0.0001
72543724|NCT00549198|144617311|SUPERIORITY_OR_OTHER|||||||0.3323||95.0||||The model includes the following covariates: treatment, age, and baseline biomarker value.|ANOVA|Estimates are calculated from an ANOVA model. Parameters are analyzed based on log transformed data.||||||0.3323
72543725|NCT00549198|144617312|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||The model includes the following covariates: treatment, baseline biomarker value, baseline CD4, and gender.|ANOVA|Estimates are calculated from an ANOVA model. Parameters are analyzed based on log transformed data.||||||<0.0001
72411231|NCT01070810|144330651|SUPERIORITY||Hazard Ratio (HR)|0.99||||0.97|TWO_SIDED|95.0|0.61|1.62|||Regression, Cox|||Time to shock reversal was complicated by a high incidence of death prior to the event. To account for this we classified death as a competing risk event and used the estimated cumulative incidence function (CIF) to illustrate the comparison of CIFs between the two treatment groups using the Fine-Gray competing risk model. We tested the subdistribution hazards of these two CIF functions and obtained the estimated hazard ratio with 95% confidence intervals.||1.62|0.61|0.97
72411232|NCT01070810|144330652|SUPERIORITY|||||||0.15|||||||t-test, 2 sided|||||||0.15
72411233|NCT01070810|144330653|SUPERIORITY|||||||0.03|||||||Wilcoxon (Mann-Whitney)|||||||0.03
72411234|NCT01070810|144330654|SUPERIORITY|||||||0.1|||||||Chi-squared|||||||0.10
72411235|NCT05061446|144330662|OTHER||Difference in percentage|6.7|||||TWO_SIDED|95.0|-5.96|19.29||||||||19.29|-5.96|
72411236|NCT05061446|144330662|OTHER||Difference in percentage|26.3|||||TWO_SIDED|95.0|6.52|46.12||||||||46.12|6.52|
72411237|NCT05061446|144330663|OTHER||Difference in percentage|6.7|||||TWO_SIDED|95.0|-5.96|19.29||||||||19.29|-5.96|
72543726|NCT00549198|144617313|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||The model includes the following covariates: treatment, age, and baseline biomarker value.|ANOVA|Estimates are calculated from ana ANOVA model. Parameters are analyzed based on log transformed data.||||||<0.0001
72543727|NCT00549198|144617314|SUPERIORITY_OR_OTHER|||||||0.0019||95.0||||The model includes the following covariates: treatment, baseline biomarker value, and gender.|ANOVA|Estimates are calculated from an ANOVA model.||||||0.0019
72543728|NCT00549198|144617315|SUPERIORITY_OR_OTHER|||||||0.0019||95.0||||The model includes the following covariates: treatment, age, baseline biomarker value, and baseline CD4.|ANOVA|Estimates are calculated from an ANOVA model.||||||0.0019
72543729|NCT00549198|144617316|SUPERIORITY_OR_OTHER|||||||0.0266||95.0||||The model includes the following covariates: treatment, baseline biomarker value, and baseline CD4.|ANOVA|Estimates are calculated from an ANOVA model.||||||0.0266
72543730|NCT02967133|144617347|SUPERIORITY|||||||0.5186|||||||Log Rank|||||||0.5186
72543731|NCT01034137|144617348|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.996|||<|0.001|TWO_SIDED|95.0|1.589|2.506|||Cochran-Mantel-Haenszel|||The SRR was compared between the treatment groups by means of the Cochran-Mantel-Haenszel (CMH) test taking into account the stratification factors used for randomization.||2.506|1.589|< 0.001
72543732|NCT01034137|144617348|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.855|||<|0.001|TWO_SIDED|95.0|1.481|2.323|||Cochran-Mantel-Haenszel|||The SRR was compared between the treatment groups by means of the CMH test taking into account the stratification factors used for randomization.||2.323|1.481|< 0.001
72578403|NCT03104400|144684251|OTHER|The overall type I error rate of the primary and the 14 ranked secondary endpoints was controlled using a two-part sequential graphical multiple testing procedure starting with the primary endpoint using α/2 for each dose followed by a prespecified α transfer path.|LS Mean Difference|-19.8|||<|0.0001|TWO_SIDED|95.0|-22.3|-17.3||This comparison was not tested for statistical significance because the hierarchical testing procedures stopped at ACR 20 at Week 12 superiority test of upadacitinib 15 mg versus adalimumab 40 mg.|Mixed Effect Model Repeated Measurement|MMRM analysis including treatment, visit, treatment-by-visit interaction, current DMARD use (yes/no) as fixed factors and Baseline value as covariate.|Treatment Difference = Upadacitinib - Placebo|||-17.3|-22.3|<0.0001
72543733|NCT01034137|144617348|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.03||||0.616|TWO_SIDED|95.0|0.915|1.16|||Cochran-Mantel-Haenszel|||The SRR was compared between the treatment groups by means of the CMH test taking into account the stratification factors used for randomization.||1.160|0.915|0.616
72543734|NCT00936377|144617390|SUPERIORITY_OR_OTHER|||||||0.64|||||||Wilcoxon (Mann-Whitney)|||||||0.64
72543735|NCT00936377|144617390|SUPERIORITY_OR_OTHER|||||||0.27|||||||Wilcoxon (Mann-Whitney)|||||||0.27
72543736|NCT00936377|144617391|SUPERIORITY_OR_OTHER|||||||0.05|||||||Wilcoxon (Mann-Whitney)|||||||0.05
72411238|NCT05061446|144330663|OTHER||Difference in percentage|26.3|||||TWO_SIDED|95.0|6.52|46.12||||||||46.12|6.52|
72411239|NCT05061446|144330664|OTHER||Difference in percentage|20.0|||||TWO_SIDED|95.0|-0.24|40.24||||||||40.24|-0.24|
72411240|NCT05061446|144330664|OTHER||Difference in percentage|31.6|||||TWO_SIDED|95.0|10.68|52.48||||||||52.48|10.68|
72411241|NCT05061446|144330665|OTHER||Difference in percentage|6.7|||||TWO_SIDED|95.0|-5.96|19.29||||||||19.29|-5.96|
72411242|NCT05061446|144330665|OTHER||Difference in percentage|5.3|||||TWO_SIDED|95.0|-4.78|15.3||||||||15.30|-4.78|
72543737|NCT00936377|144617391|SUPERIORITY_OR_OTHER|||||||0.05|||||||Wilcoxon (Mann-Whitney)|||||||0.05
72543738|NCT00936377|144617392|SUPERIORITY_OR_OTHER|||||||0.066|||||||Wilcoxon (Mann-Whitney)|||||||0.066
72578404|NCT03104400|144684252|OTHER||Response Rate Difference|24.3|||<|0.0001|TWO_SIDED|95.0|18.7|29.9||This comparison was not part of the pre-specified multiplicity testing sequence.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted for the main stratification factor of current DMARD use (yes/no).|Response Rate Difference = Upadacitinib - Placebo|||29.9|18.7|<0.0001
72578405|NCT03104400|144684252|OTHER||Response Rate Difference|38.5|||<|0.0001|TWO_SIDED|95.0|32.8|44.3||This comparison was not part of the pre-specified multiplicity testing sequence.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusting for the main stratification factor of current DMARD use (yes/no).|Response Rate Difference = Upadacitinib - Placebo|||44.3|32.8|<0.0001
72578406|NCT03104400|144684253|OTHER||Response Rate Difference|13.3|||<|0.0001|TWO_SIDED|95.0|9.5|17.0||This comparison was not part of the pre-specified multiplicity testing sequence.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusting for the main stratification factor of current DMARD use (yes/no).|Response Rate Difference = Upadacitinib - Placebo|||17.0|9.5|<0.0001
72578407|NCT03104400|144684253|OTHER||Response Rate Difference|22.9|||<|0.0001|TWO_SIDED|95.0|18.5|27.3||This comparison was not part of the pre-specified multiplicity testing sequence.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusting for the main stratification factor of current DMARD use (yes/no).|Response Rate Difference = Upadacitinib - Placebo|||27.3|18.5|<0.0001
72578408|NCT03104400|144684254|OTHER||Response Rate Difference|16.1|||<|0.0001|TWO_SIDED|95.0|10.9|21.4||This comparison was not part of the pre-specified multiplicity testing sequence.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusting for the main stratification factor of current DMARD use (yes/no).|Response Rate Difference = Upadacitinib - Placebo|||21.4|10.9|<0.0001
72411243|NCT05061446|144330666|OTHER||Difference in percentage|26.2|||||TWO_SIDED|95.0|-1.22|53.6||||||||53.60|-1.22|
72411244|NCT05061446|144330666|OTHER||Difference in percentage|45.5|||||TWO_SIDED|95.0|19.3|71.68||||||||71.68|19.30|
72578409|NCT03104400|144684254|OTHER||Response Rate Difference|26.2|||<|0.0001|TWO_SIDED|95.0|20.7|31.8||This comparison was not part of the pre-specified multiplicity testing sequence.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusting for the main stratification factor of current DMARD use (yes/no).|Response Rate Difference = Upadacitinib - Placebo|||31.8|20.7|<0.0001
72578410|NCT02129608|144684276|SUPERIORITY_OR_OTHER|||||||0.398|||||||t-test, 2 sided|||||||0.398
72411245|NCT03880578|144330669|SUPERIORITY||Mean Difference (Final Values)|-10.3|||<|0.001|TWO_SIDED|95.0|-14.9|-5.7|||Mixed Models Analysis|The outcome measure is change over time between treatment groups, reported as a mean adjusted difference.|change in the composite score of the ThyPRO between groups|||-5.7|-14.9|<0.001
72411246|NCT03880578|144330670|SUPERIORITY||Mean Difference (Final Values)|-2.14||||0.06|TWO_SIDED|95.0|-4.34|0.06|||Mixed Models Analysis|||||0.06|-4.34|0.06
72411247|NCT03880578|144330671|SUPERIORITY||Median Difference (Final Values)|1.7|||<|0.001|TWO_SIDED|95.0|1.27|2.03|||Mixed Models Analysis||MAD obtained after log transformation of TSH|||2.03|1.27|<0.001
72411248|NCT03880578|144330672|SUPERIORITY||Mean Difference (Final Values)|-0.61|||<|0.001|TWO_SIDED|95.0|-0.87|-0.35|||Mixed Models Analysis|||FT3||-0.35|-0.87|<0.001
72578411|NCT02129608|144684276|SUPERIORITY_OR_OTHER|||||||0.436|||||||t-test, 2 sided|||||||0.436
72578412|NCT02129608|144684277|SUPERIORITY_OR_OTHER|||||||0.07|||||||t-test, 2 sided|||||||0.070
72578413|NCT02129608|144684277|SUPERIORITY_OR_OTHER|||||||0.95|||||||t-test, 2 sided|||||||0.950
72411249|NCT03880578|144330672|SUPERIORITY||Mean Difference (Final Values)|-0.83||||0.12|TWO_SIDED|95.0|-1.81|0.15|||Mixed Models Analysis|||FT4||0.15|-1.81|0.12
72411250|NCT03880578|144330673|SUPERIORITY||Mean Difference (Final Values)|-11.6|||<|0.001|TWO_SIDED|95.0|-14.6|-8.5|||Mixed Models Analysis|||||-8.5|-14.6|<0.001
72411251|NCT03299192|144330693|SUPERIORITY|||||||0.001||||||This feasibility study is small and not designed to look at outcome statistics|GEE with Ancova features|||||||.001
72411252|NCT01418209|144330696|SUPERIORITY_OR_OTHER|||||||0.02||||||P-values from active treatment vs. placebo contrasts in a repeated measures linear model of outcome as a function of treatment arm, clinical site, week, and baseline outcome. The a priori threshold for statistical significance was 0.025.|repeated measures linear model|Robust standard errors were calculated using generalized estimating equations to account for within-participant correlation between repeated measures.||Outcome differences between active treatment and placebo||||0.02
72543739|NCT00936377|144617392|SUPERIORITY_OR_OTHER|||||||0.27|||||||Wilcoxon (Mann-Whitney)|||||||0.27
72411253|NCT01418209|144330696|SUPERIORITY_OR_OTHER|||||||0.02||||||p-values from active treatment vs. placebo contrasts in a repeated measures linear model of outcome as a function of treatment arm, clinical site, week, and baseline outcome. The a priori threshold of statistical significance was 0.025.|repeated measures linear model|Robust standard errors were calculated using generalized estimating equations to account for within-participant correlation between repeated measures.||Outcome differences between active treatment and placebo||||0.02
72543740|NCT00936377|144617393|SUPERIORITY_OR_OTHER|||||||0.18||||||Percentage of CIWA scores rates as severe|Chi-squared, Corrected|||Percentage of CIWA scores rates as severe||||0.18
72543741|NCT00936377|144617393|SUPERIORITY_OR_OTHER|||||||0.35||||||Percentage of CIWA scores rates as severe|Chi-squared, Corrected|||||||0.35
72543742|NCT00936377|144617394|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||For hypotension||||1
72543743|NCT00936377|144617394|SUPERIORITY_OR_OTHER|||||||0.47|||||||Fisher Exact|||For hypotension||||0.47
72543744|NCT00936377|144617394|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||For bradycardia||||1
72578414|NCT00451204|144684278|SUPERIORITY_OR_OTHER||Rate ratio|0.63||||0.077|TWO_SIDED|95.0|0.37|1.05|||negative binomial regression|adjusted for age, BL EDSS score, # of relapses in previous 12 mo, time since dx, previous glatiramer acetate tx, and previous interferon beta tx.||||1.05|0.37|0.077
72411254|NCT01418209|144330697|SUPERIORITY_OR_OTHER||||||<|0.001||||||P-values from active treatment vs. placebo contrasts in a repeated measures linear model of outcome as a function of treatment arm, clinical site, week, and baseline outcome. The a priori threshold for statistical significance was 0.025.|repeated measures linear model|Robust standard errors were calculated using generalized estimating equations to account for within-participant correlation between repeated measures||VMS frequency values were log transformed for modeling.||||<0.001
72543745|NCT00936377|144617394|SUPERIORITY_OR_OTHER|||||||0.2|||||||Fisher Exact|||For bradycardia||||0.2
72543746|NCT00936377|144617395|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Repeated measures ANOVA|||||||<0.05
72543747|NCT00936377|144617396|SUPERIORITY_OR_OTHER|||||||0.5|||||||Wilcoxon (Mann-Whitney)|||||||0.5
72543748|NCT00936377|144617396|SUPERIORITY_OR_OTHER|||||||0.95|||||||Wilcoxon (Mann-Whitney)|||||||0.95
72543749|NCT00936377|144617397|SUPERIORITY_OR_OTHER|||||||0.43|||||||Wilcoxon (Mann-Whitney)|||||||0.43
72543750|NCT00936377|144617397|SUPERIORITY_OR_OTHER|||||||0.64|||||||Wilcoxon (Mann-Whitney)|||||||0.64
72543751|NCT01764854|144617398|SUPERIORITY|||||||0.46|||||||ANCOVA|||AZD1722 in-patient and Placebo in-patient are not included in this analysis since it was only a one week evaluation period and an effect was not expected. Also the size (n=8) of the group was too small to .perform this analysis.||||0.46
72543752|NCT01764854|144617399|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||AZD1722 out-patient and Placebo out-patient were not included in this analysis since stool was only collected in the clinical pharmacology unit of the in-patient groups.||||<0.0001
72543753|NCT00472446|144617423|SUPERIORITY_OR_OTHER|||||||0.028|||||||t-test, 2 sided|||null hypothesis: no difference in outcome measure between superficial cervical block and placebo treatment (irrespective of timing of treatment)||||.028
72543754|NCT00472446|144617424|SUPERIORITY_OR_OTHER|||||||0.016|||||||Non-parametric ANOVA-type statistic|Non-parametric ANOVA-type statistic for pooled main effects with Box approximation, full model||null hypothesis: no difference in outcome measure between superficial cervical block and placebo treatment (irrespective of timing of treatment)||||0.016
72543755|NCT00472446|144617424|SUPERIORITY_OR_OTHER|||||||0.723|||||||Non-parametric ANOVA-type statistic|Non-parametric ANOVA-type statistic for pooled main effects with Box approximation, full model||null hypothesis: no difference in outcome measure pre-operative versus post-operative application||||0.723
72578415|NCT00451204|144684279|SUPERIORITY_OR_OTHER||Rate ratio|0.65||||0.098|TWO_SIDED|95.0|0.39|1.08|||negative binomial regression|adjusted for age, BL EDSS score, # of relapses in previous 12 months, time since dx, previous GA treatment, and previous interferon beta treatment.||||1.08|0.39|0.098
72578416|NCT00451204|144684280|SUPERIORITY_OR_OTHER||Rate ratio|0.63||||0.096|TWO_SIDED|95.0|0.36|1.09|||negative binomial regression|adjusted for age, BL EDSS score, # of relapses in previous 12 months, time since dx, previous GA treatment, and previous interferon beta treatment.||||1.09|0.36|0.096
72578417|NCT00451204|144684281|SUPERIORITY_OR_OTHER||Rate ratio|0.7||||0.179|TWO_SIDED|95.0|0.42|1.17|||negative binomial regression|adjusted for age, BL EDSS score, # of relapses in previous 12 months, time since dx, previous GA treatment, and previous interferon beta treatment.||||1.17|0.42|0.179
72578418|NCT00451204|144684282|SUPERIORITY_OR_OTHER||Rate ratio|0.49||||0.016|TWO_SIDED|95.0|0.28|0.88|||negative binomial regression|adjusted for age, BL EDSS score, # of relapses in previous 12 months, time since dx, previous GA treatment, and previous interferon beta treatment.||||0.88|0.28|0.016
72578419|NCT00451204|144684283|SUPERIORITY_OR_OTHER||Rate ratio|0.52||||0.012|TWO_SIDED|95.0|0.31|0.86|||negative binomial regression|adjusted for age, BL EDSS score, # of relapses in previous 12 months, time since dx, previous GA treatment, and previous interferon beta treatment.||||0.86|0.31|0.012
72578420|NCT00794339|144684294|EQUIVALENCE|equivalence margin=0||||||0.4883|||||||Wilcoxon (Mann-Whitney)|||Participants were divided into two groups by whether their T/M Ratio fell at or above vs. below the observed median of 7.3 and the the median survival was compared between the 2 groups.||||0.4883
72578421|NCT00794339|144684295|EQUIVALENCE|no equivalence margin|Slope|-0.1235|STANDARD_ERROR_OF_MEAN|1.6988||0.1924|TWO_SIDED||||||Regression, Logistic|||Logistic Regression Modeling Complete Metabolic Response by T/M Ratio||||0.1924
72543756|NCT00472446|144617426|SUPERIORITY_OR_OTHER|||||||0.94|TWO_SIDED||||||Fisher Exact|mid p value of the two-sided Fisher test||"null hypothesis: outcome measure (Proportion of patients taking analgetics) is equal between superficial cervical block and placebo treatment (irrespective of timing)~Proportion taking Paracetamol:"||||0.94
72543757|NCT00472446|144617426|SUPERIORITY_OR_OTHER|||||||0.58|TWO_SIDED||||||Fisher Exact|mid p value of two-sided Fisher test||"null hypothesis: outcome measure (Proportion of patients taking analgetics) is equal between superficial cervical block and placebo treatment (irrespective of timing)~Proportion taking Metamizole:"||||0.58
72543758|NCT00472446|144617427|SUPERIORITY_OR_OTHER|||||||0.328|TWO_SIDED||||||Non-parametric ANOVA-type|Non-parametric ANOVA-type statistic for pooled main effects with Box approximation, full model||"null hypothesis: no difference in pooled dose of analgetics, superficial block versus Placebo~outcome: paracetamol"||||0.328
72543759|NCT00472446|144617427|SUPERIORITY_OR_OTHER|||||||0.81|TWO_SIDED||||||Non-parametric ANOVA-type|Non-parametric ANOVA-type statistic for pooled main effects with Box approximation, full model||"null hypothesis: no difference in pooled dose of analgetics, superficial block versus Placebo~outcome: metamizole"||||0.81
72543760|NCT00472446|144617427|SUPERIORITY_OR_OTHER|||||||0.331|TWO_SIDED||||||Non-parametric ANOVA-type statistic|Non-parametric ANOVA-type statistic for pooled main effects with Box approximation, full model||"null hypothesis: no difference in outcome measure pre-operative and post-operative application~outcome measure: pooled paracetamol dose"||||0.331
72543761|NCT00472446|144617427|SUPERIORITY_OR_OTHER|||||||0.44|TWO_SIDED||||||Non-parametric ANOVA-type statistic|Non-parametric ANOVA-type statistic for pooled main effects with Box approximation, full model||"null hypothesis: no difference in outcome measure pre-operative and post-operative application~outcome measure: pooled metamizole dose"||||0.440
72543762|NCT00472446|144617428|SUPERIORITY_OR_OTHER|||||||0.925|TWO_SIDED||||||non-parametric ANOVA-type statistic|non-parametric ANOVA-type statistic for pooled main effects, full model||null hypothesis: no difference in outcome measure for superficial cervical block versus placebo treatment||||0.925
72543763|NCT01275313|144617429|EQUIVALENCE|Power calculation: To determine a difference of 20% in the control group and 10% in the treatment group with 80% power, 440 participants would be needed.||||||0.77|||||||Chi-squared, Corrected|||Null hypothesis: At-risk nursing home residents provided with an individually-configured manual lightweight wheelchair and skin protection cushion have the same incidence of pressure injury development compared to individuals using a facility-provided manual wheelchair modified with a skin protection cushion and related adjustments.||||0.77
72543764|NCT01165684|144617430|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was considered confirmed if the upper bound of the two-sided 95% CI was below or equal to 0.4% or equivalently if the p-value for the one-sided test of was less than or equal to 2.5%, where D is the mean treatment difference (step-wise regimen minus basal-bolus regimen).|Estimated treatment difference, Mean|0.14||||0.088||95.0|-0.02|0.3|||Regression, Linear|||||0.30|-0.02|0.088
72543765|NCT01165684|144617431|SUPERIORITY_OR_OTHER||Estimated treatment difference, Mean|0.55|||<|0.001||95.0|0.42|0.69|||Regression, Linear|||||0.69|0.42|<0.001
72543766|NCT01165684|144617432|SUPERIORITY_OR_OTHER||Estimated treatment difference, Mean|0.37|||<|0.001||95.0|0.21|0.53|||Regression, Linear|||||0.53|0.21|<0.001
72543767|NCT01165684|144617433|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.85|||<|0.001||95.0|4.12|11.39|||Regression, Logistic|||||11.39|4.12|<0.001
72543768|NCT01165684|144617434|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.38|||<|0.001||95.0|1.56|3.64|||Regression, Logistic|||||3.64|1.56|<0.001
72543769|NCT01165684|144617435|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.36||||0.146||95.0|0.9|2.07|||Regression, Logistic|||||2.07|0.90|0.146
72543770|NCT01165684|144617438|SUPERIORITY_OR_OTHER||Estimated Mean|0.12||||0.635||95.0|-0.37|0.6|||Regression, Linear|||||0.60|-0.37|0.635
72543771|NCT01165684|144617441|SUPERIORITY_OR_OTHER||Estimated mean|0.36||||0.046||95.0|0.01|0.71|||Regression, Linear|||||0.71|0.01|0.046
72543772|NCT01165684|144617442|SUPERIORITY_OR_OTHER||Estimated mean|-0.48||||0.228||95.0|-1.25|0.3|||Regression, Linear|||||0.30|-1.25|0.228
72543773|NCT01165684|144617443|SUPERIORITY_OR_OTHER||Estimated mean|-0.17||||0.224||95.0|-0.45|0.11|||Regression, Linear|||||0.11|-0.45|0.224
72543774|NCT01797120|144617504|SUPERIORITY||Hazard Ratio (HR)|0.61||||0.02|TWO_SIDED|95.0|0.4|0.92|||Log Rank|Log rank test was stratified on ECOG performance status, measurable disease, and prior chemotherapy for metastatic disease||||0.92|0.40|0.02
72543775|NCT01797120|144617505|SUPERIORITY|||||||0.01|||||||Fisher Exact|||||||0.01
72543776|NCT01797120|144617506|SUPERIORITY|||||||0.47|||||||Fisher Exact|||||||0.47
72543777|NCT02462421|144617508|OTHER|Probability that the observed difference was the result of random variation rather than a difference between the two populations.||||||0.92||||||No adjustment for multiple comparisons. Viewed as unnecessary inasmuch as none of the comparisons achieved p\<0.05.|t-test, 2 sided|||"Each of the variant genotypes was compared to the control group (homozygous for major alleles at all three genetic loci) in an unpaired t-test. The study was terminated early because it was clear that we would not meet our recruitment targets and that the study was likely underpowered.~Null hypothesis: pharmacodynamic response is the same in the control group and homozygotes for the genetic variant."||||0.92
72543778|NCT02462421|144617508|OTHER|Probability that the observed difference was the result of random variation rather than a difference between the two populations.||||||0.63||||||Not corrected for multiple comparisons|t-test, 2 sided|||Null hypothesis: pharmacodynamic response is the same in the control group and homozygotes for the genetic variant.||||0.63
72543779|NCT02462421|144617508|OTHER|Probability that the observed difference was the result of random variation rather than a difference between the two populations.||||||0.86||||||Not adjusted for multiple comparisons|t-test, 2 sided|||Null hypothesis: pharmacodynamic response is the same in the control group and homozygotes for the genetic variant.||||0.86
72543780|NCT02462421|144617509|OTHER|"We compared the two groups (wild type versus SLC2A9 variant homozygotes. Null hypothesis: there are no differences between the two groups with respect to the pharmacodynamic effect of canagliflozin on fractional excretion of uric acid in the urine."||||||0.04||||||Because the study was terminated early, we did not have sufficient statistical power to adjust for multiple comparisons. We are reporting a nominal p-value without adjusting for multiple comparisons|t-test, 2 sided|||The study was terminated early because of slow recruitment. As a result the study did not achieve the statistical power that had been planned.||||0.04
72543781|NCT02462421|144617510|OTHER|Probability that the observed difference was the result of random variation rather than a difference between the two populations.||||||0.07||||||Not corrected for multiple comparisons|t-test, 2 sided|||Null hypothesis: pharmacodynamic response is the same in the control group and homozygotes for the genetic variant.||||0.07
72543782|NCT02462421|144617510|OTHER|Probability that the observed difference was the result of random variation rather than a difference between the two populations.||||||0.53||||||Not corrected for multiple comparisons.|t-test, 2 sided|||Null hypothesis: pharmacodynamic response is the same in the control group and homozygotes for the genetic variant.||||0.53
72543783|NCT02462421|144617510|OTHER|Probability that the observed difference was the result of random variation rather than a difference between the two populations.||||||0.92||||||Not corrected for multiple comparisons.|t-test, 2 sided|||Null hypothesis: pharmacodynamic response is the same in the control group and homozygotes for the genetic variant.||||0.92
72543784|NCT02462421|144617511|OTHER|Probability that the observed difference was the result of random variation rather than a difference between the two populations.|||||<|0.01||||||Not corrected for multiple comparisons.|t-test, 2 sided|||Null hypothesis: pharmacodynamic response is the same in the control group and homozygotes for the genetic variant.||||<0.01
72543785|NCT02462421|144617511|OTHER|Probability that the observed difference was the result of random variation rather than a difference between the two populations.||||||0.77||||||Not corrected for multiple comparisons.|t-test, 2 sided|||Null hypothesis: pharmacodynamic response is the same in the control group and homozygotes for the genetic variant.||||0.77
72543786|NCT02462421|144617511|OTHER|Probability that the observed difference was the result of random variation rather than a difference between the two populations.||||||0.65||||||Not corrected for multiple comparisons.|t-test, 2 sided|||Null hypothesis: pharmacodynamic response is the same in the control group and homozygotes for the genetic variant.||||0.65
72543787|NCT02462421|144617512|OTHER|Null hypothesis: None of the three genotypes is associated with an alteration in the pharmacodynamic effect of canagliflozin on urinary Na excretion||||||0.2||||||Because the study was terminated early, the study does not have sufficient statistical power to adjust for multiple comparisons. Accordingly, nominal p-values are reported.|t-test, 2 sided|||"The wild type genotype group was compared to homozygotes for each of the three other genotypes."||||0.20
72543788|NCT02462421|144617512|OTHER|Probability that the observed difference was the result of random variation rather than a difference between the two populations.||||||0.01|||||||t-test, 2 sided|||Null hypothesis: pharmacodynamic response is the same in the control group and homozygotes for the genetic variant.||||0.01
72543789|NCT02462421|144617512|OTHER|Probability that the observed difference was the result of random variation rather than a difference between the two populations.||||||0.16||||||Not corrected for multiple comparisons.|t-test, 2 sided|||Null hypothesis: pharmacodynamic response is the same in the control group and homozygotes for the genetic variant.||||0.16
72543790|NCT02462421|144617513|OTHER|Probability that the observed difference was the result of random variation rather than a difference between the two populations.||||||0.21||||||Not corrected for multiple comparisons.|t-test, 2 sided|||Null hypothesis: pharmacodynamic response is the same in the control group and homozygotes for the genetic variant.||||0.21
72543791|NCT02462421|144617513|OTHER|Probability that the observed difference was the result of random variation rather than a difference between the two populations.||||||0.92||||||Not corrected for multiple comparisons.|t-test, 2 sided|||Null hypothesis: pharmacodynamic response is the same in the control group and homozygotes for the genetic variant.||||0.92
72543792|NCT02462421|144617513|OTHER|Probability that the observed difference was the result of random variation rather than a difference between the two populations.||||||0.39||||||Not corrected for multiple comparisons.|t-test, 2 sided|||Not corrected for multiple comparisons.||||0.39
72543793|NCT01339910|144617537|SUPERIORITY||Difference in 18 month OS (MAC-RIC)|9.8||||0.07|TWO_SIDED|95.0|-0.8|20.3||This final test was performed at a 0.049 significance level, since 0.001 was spent at interim analyses and the overall significance level was 0.050.|Difference in Kaplan-Meier estimators|||The null hypothesis is that there is no difference in overall survival at 18 months post-randomization between AML/MDS participants receiving MAC and RIC conditioning regimens. 18 month overall survival was compared between treatment arms using the difference in Kaplan-Meier estimators, which should be close to 0 under the null hypothesis.||20.3|-0.8|0.07
72578422|NCT00794339|144684296|EQUIVALENCE|equivalence margin = 0||||||0.309|||||||Wilcoxon (Mann-Whitney)|||Participants were divided into two groups: those at or above the median for T/M Ratio (7.3) vs. those below, and the time to primary tumor recurrence was compared between the 2 goups.||||0.3090
72411255|NCT01418209|144330697|SUPERIORITY_OR_OTHER|||||||0.005||||||P-values from active treatment vs. placebo contrasts in a repeated measures linear model of outcome as a function of treatment arm, clinical site, week, and baseline outcome. The a priori threshold for statistical significance was 0.025.|repeated measures linear model|Robust standard errors were calculated using generalized estimating equations to account for within-participant correlation between repeated measures||VMS frequency values were log transformed for modeling.||||0.005
72543794|NCT01339910|144617538|SUPERIORITY||Difference in 18 month RFS (MAC-RIC)|20.4|||<|0.01|TWO_SIDED|95.0|8.9|32.0||Test performed at a significance level of 0.05|Difference in Kaplan-Meier estimators|||The null hypothesis is that there is no difference in relapse-free survival at 18 months post-randomization between AML/MDS participants receiving MAC and RIC conditioning regimens. 18 month relapse-free survival was compared between treatment arms using the difference in Kaplan-Meier estimators, which should be close to 0 under the null hypothesis.||32.0|8.9|< 0.01
72578423|NCT00794339|144684297|EQUIVALENCE|equivalence margin=0||||||0.5291|||||||Regression, Logistic|||Logistic Regression Evaluating Tissue to Muscle (T/M) uptake ratio as a Predictor of PELVIC Lymph Node Metastases at Baseline||||0.5291
72578424|NCT00794339|144684297|EQUIVALENCE|equivalence margin=0||||||0.9684|||||||Regression, Logistic|||Logistic Regression Evaluating Tissue to Muscle (T/M) uptake Ratio as a Predictor of COMMON ILIAC Lymph Node Metastases at Baseline||||0.9684
72578425|NCT00794339|144684297|EQUIVALENCE|equivalence margin=0||||||0.7327|||||||Regression, Logistic|||Logistic Regression Evaluating Tissue to Muscle (T/M) uptake Ratio as a Predictor of Para Aortic Lymph Node Metastases at Baseline||||0.7327
72578426|NCT00794339|144684307|EQUIVALENCE|equivalence margin=0||||||0.4981|||||||Wilcoxon (Mann-Whitney)|||Participants were divided into two groups by whether their T/M Ratio fell at or above vs. below the observed median of 7.3 and the time to observe new distant metastases was compared between the groups||||.4981
72411256|NCT01418209|144330699|SUPERIORITY_OR_OTHER|||||||0.01||||||P-values from active treatment vs. placebo contrasts in a repeated measures linear model of outcome as a function of treatment arm, clinical site, week, and baseline outcome. The a priori threshold for statistical significance was 0.025.|repeated measures linear model|Robust standard errors were calculated using generalized estimating equations to account for within-participant correlation between repeated measures.||Outcome differences between active treatment and placebo||||0.01
72578427|NCT01495702|144684358|NON_INFERIORITY_OR_EQUIVALENCE|The null hypothesis was that the Stribild group was at least 12% worse than the NNRTI+FTC/TDF group with respect to the percentage of participants maintaining HIV-1 RNA \< 50 copies/mL at Week 48. The alternative hypothesis was that the Stribild group was less than 12% worse than the NNRTI+FTC/TDF group.|Difference in proportions|5.3||||0.066|TWO_SIDED|95.0|-0.5|12.0|||Fisher Exact||The 95% confidence interval (CI) for the difference was from unconditional exact method using 2 inverted 1-sided tests with the standardized statistic using StatXact.|||12.0|-0.5|0.066
72578428|NCT04152863|144684362|SUPERIORITY||Mean Difference (Net)|11.9||||0.1812|TWO_SIDED|90.0|-9.5|32.5|||Stratified Miettinen & Nurminen method|To ensure adequate number of participants, strata were combined according to sSAP when one treatment had 0 participants in a particular stratum.||||32.5|-9.5|0.1812
72578429|NCT04152863|144684362|SUPERIORITY||Mean Difference (Net)|4.8||||0.3548|TWO_SIDED|90.0|-16.2|25.5|||Stratified Miettinen & Nurminen method|To ensure adequate number of participants, strata were combined according to sSAP when one treatment had 0 participants in a particular stratum.||||25.5|-16.2|0.3548
72578430|NCT04152863|144684362|OTHER|Difference in percentage based on Miettinen \& Nurminen method.|Difference in %|7.1|||||TWO_SIDED|90.0|-14.6|28.2||||||||28.2|-14.6|
72578431|NCT04152863|144684363|OTHER|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate.|Hazard Ratio (HR)|1.06|||||TWO_SIDED|95.0|0.5|2.27||||||||2.27|0.50|
72578432|NCT04152863|144684363|OTHER|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate.|Hazard Ratio (HR)|1.08|||||TWO_SIDED|95.0|0.51|2.29||||||||2.29|0.51|
72578433|NCT04152863|144684363|OTHER|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate.|Hazard Ratio (HR)|1.01|||||TWO_SIDED|95.0|0.5|2.04||||||||2.04|0.50|
72578434|NCT04152863|144684365|OTHER|Difference in percentage based on Miettinen \& Nurminen method.|Difference in percentage|-2.1|||||TWO_SIDED|90.0|-23.1|19.2||||||||19.2|-23.1|
72578435|NCT04152863|144684365|OTHER|Difference in percentage based on Miettinen \& Nurminen method.|Difference in percentage|-2.1|||||TWO_SIDED|90.0|-23.1|19.2||||||||19.2|-23.1|
72578436|NCT04152863|144684365|OTHER|Difference in percentage based on Miettinen \& Nurminen method.|Difference in %|0.0|||||TWO_SIDED|90.0|-21.2|21.2||||||||21.2|-21.2|
72578437|NCT04152863|144684366|OTHER|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate.|Hazard Ratio (HR)|1.45|||||TWO_SIDED|95.0|0.7|3.02||||||||3.02|0.70|
72578438|NCT04152863|144684366|OTHER|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate.|Hazard Ratio (HR)|1.29|||||TWO_SIDED|95.0|0.62|2.68||||||||2.68|0.62|
72578439|NCT04152863|144684366|OTHER|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate.|Hazard Ratio (HR)|1.16|||||TWO_SIDED|95.0|0.6|2.22||||||||2.22|0.60|
72578440|NCT04152863|144684368|OTHER|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate.|Hazard Ratio (HR)|1.64|||||TWO_SIDED|95.0|0.71|3.79||||||||3.79|0.71|
72578441|NCT04152863|144684368|OTHER|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate.|Hazard Ratio (HR)|1.12|||||TWO_SIDED|95.0|0.47|2.68||||||||2.68|0.47|
72578442|NCT04152863|144684368|OTHER|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate.|Hazard Ratio (HR)|1.39|||||TWO_SIDED|95.0|0.64|3.02||||||||3.02|0.64|
72578443|NCT05044195|144684399|NON_INFERIORITY|Non-inferiority criteria for the GMT ratio: upper limit (UL) of the 95% confidence interval (CI) for the inter-group GMT ratio is ≤1.5 for each vaccine strain|GMT ratio|0.802|||||TWO_SIDED|95.0|0.738|0.871||||||A/H1N1||0.871|0.738|
72578444|NCT05044195|144684399|NON_INFERIORITY|Non-inferiority criteria for the GMT ratio: UL of the 95% CI for the inter-group GMT ratio is ≤1.5 for each vaccine strain|GMT ratio|0.9|||||TWO_SIDED|95.0|0.819|0.989||||||A/H3N2||0.989|0.819|
72578445|NCT05044195|144684399|NON_INFERIORITY|Non-inferiority criteria for the GMT ratio: UL of the 95% CI for the inter-group GMT ratio is ≤1.5 for each vaccine strain|GMT ratio|0.944|||||TWO_SIDED|95.0|0.88|1.012||||||B/Yamagata||1.012|0.880|
72578446|NCT05044195|144684399|NON_INFERIORITY|Non-inferiority criteria for the GMT ratio: UL of the 95% CI for the inter-group GMT ratio is ≤1.5 for each vaccine strain|GMT ratio|0.992|||||TWO_SIDED|95.0|0.923|1.067||||||B/Victoria||1.067|0.923|
72578447|NCT05044195|144684400|NON_INFERIORITY|Non-inferiority criteria for the SCR difference: UL of the 95% CI for the difference in SCR is ≤10% for each vaccine strain|SCR difference|-4.4|||||TWO_SIDED|95.0|-7.97|-0.74||||||A/H1N1||-0.74|-7.97|
72578448|NCT05044195|144684400|NON_INFERIORITY|Non-inferiority criteria for the SCR difference: UL of the 95% CI for the difference in SCR is ≤10% for each vaccine strain|SCR difference|-1.8|||||TWO_SIDED|95.0|-6.14|2.48||||||A/H3N2||2.48|-6.14|
72578449|NCT05044195|144684400|NON_INFERIORITY|Non-inferiority criteria for the SCR difference: UL of the 95% CI for the difference in SCR is ≤10% for each vaccine strain|SCR difference|-2.4|||||TWO_SIDED|95.0|-6.77|2.0||||||B/Yamagata||2.00|-6.77|
72578450|NCT05044195|144684400|NON_INFERIORITY|Non-inferiority criteria for the SCR difference: UL of the 95% CI for the difference in SCR is ≤10% for each vaccine strain|SCR difference|-3.9|||||TWO_SIDED|95.0|-8.31|0.45||||||B/Victoria||0.45|-8.31|
72578451|NCT05044195|144684401|SUPERIORITY||GMT ratio|0.808|||||TWO_SIDED|95.0|0.745|0.876||||||A/H1N1||0.876|0.745|
72578452|NCT05044195|144684401|SUPERIORITY||GMT ratio|0.91|||||TWO_SIDED|95.0|0.829|0.998||||||A/H3N2||0.998|0.829|
72578453|NCT05044195|144684401|SUPERIORITY||GMT ratio|0.947|||||TWO_SIDED|95.0|0.884|1.014||||||B/Yamagata||1.014|0.884|
72578454|NCT05044195|144684401|SUPERIORITY||GMT ratio|1.0|||||TWO_SIDED|95.0|0.931|1.075||||||B/Victoria||1.075|0.931|
72578455|NCT05044195|144684402|OTHER||GMT ratio|0.87|||||TWO_SIDED|95.0|0.803|0.944||||||A/H1N1||0.944|0.803|
72578456|NCT05044195|144684402|OTHER||GMT ratio|0.953|||||TWO_SIDED|95.0|0.88|1.032||||||A/H3N2||1.032|0.880|
72578457|NCT05044195|144684402|OTHER||GMT ratio|1.013|||||TWO_SIDED|95.0|0.953|1.077||||||B/Yamagata||1.077|0.953|
72578458|NCT05044195|144684402|OTHER||GMT ratio|1.028|||||TWO_SIDED|95.0|0.963|1.098||||||B/Victoria||1.098|0.963|
72578459|NCT05044195|144684410|OTHER||GMT ratio|0.838|||||TWO_SIDED|95.0|0.751|0.936||||||A/H1N1 (50 to 59 years)||0.936|0.751|
72578460|NCT05044195|144684410|OTHER||GMT ratio|0.924|||||TWO_SIDED|95.0|0.821|1.04||||||A/H3N2 (50 to 59 years)||1.040|0.821|
72578461|NCT05044195|144684410|OTHER||GMT ratio|0.926|||||TWO_SIDED|95.0|0.845|1.015||||||B/Yamagata (50 to 59 years)||1.015|0.845|
72578462|NCT05044195|144684410|OTHER||GMT ratio|0.989|||||TWO_SIDED|95.0|0.901|1.087||||||B/Victoria (50 to 59 years)||1.087|0.901|
72578463|NCT05044195|144684410|OTHER||GMT ratio|0.767|||||TWO_SIDED|95.0|0.681|0.864||||||A/H1N1 (60 to 64 years)||0.864|0.681|
72578464|NCT05044195|144684410|OTHER||GMT ratio|0.89|||||TWO_SIDED|95.0|0.766|1.033||||||A/H3N2 (60 to 64 years)||1.033|0.766|
72578465|NCT05044195|144684410|OTHER||GMT ratio|0.974|||||TWO_SIDED|95.0|0.879|1.079||||||B/Yamagata (60 to 64 years)||1.079|0.879|
72578466|NCT05044195|144684410|OTHER||GMT ratio|1.013|||||TWO_SIDED|95.0|0.905|1.133||||||B/Victoria (60 to 64 years)||1.133|0.905|
72578467|NCT05044195|144684411|OTHER||GMT ratio|0.844|||||TWO_SIDED|95.0|0.761|0.935||||||A/H1N1 (yes)||0.935|0.761|
72578468|NCT05044195|144684411|OTHER||GMT ratio|1.01|||||TWO_SIDED|95.0|0.904|1.128||||||A/H3N2 (yes)||1.128|0.904|
72578469|NCT05044195|144684411|OTHER||GMT ratio|0.948|||||TWO_SIDED|95.0|0.883|1.016||||||B/Yamagata (yes)||1.016|0.883|
72578470|NCT05044195|144684411|OTHER||GMT ratio|0.997|||||TWO_SIDED|95.0|0.926|1.073||||||B/Victoria (yes)||1.073|0.926|
72578471|NCT05044195|144684411|OTHER||GMT ratio|0.772|||||TWO_SIDED|95.0|0.677|0.88||||||A/H1N1 (no)||0.880|0.677|
72578472|NCT05044195|144684411|OTHER||GMT ratio|0.801|||||TWO_SIDED|95.0|0.683|0.941||||||A/H3N2 (no)||0.941|0.683|
72578473|NCT05044195|144684411|OTHER||GMT ratio|0.945|||||TWO_SIDED|95.0|0.831|1.076||||||B/Yamagata (no)||1.076|0.831|
72578474|NCT05044195|144684411|OTHER||GMT ratio|1.007|||||TWO_SIDED|95.0|0.881|1.151||||||B/Victoria (no)||1.151|0.881|
72578475|NCT05044195|144684412|OTHER||GMT ratio|0.82|||||TWO_SIDED|95.0|0.752|0.894||||||A/H1N1 (Comorbidity Risk Score \<50)||0.894|0.752|
72578476|NCT05044195|144684412|OTHER||GMT ratio|0.933|||||TWO_SIDED|95.0|0.846|1.029||||||A/H3N2 (Comorbidity Risk Score \<50)||1.029|0.846|
72578477|NCT05044195|144684412|OTHER||GMTratio|0.972|||||TWO_SIDED|95.0|0.904|1.046||||||B/Yamagata (Comorbidity Risk Score \<50)||1.046|0.904|
72578478|NCT05044195|144684412|OTHER||GMT ratio|1.013|||||TWO_SIDED|95.0|0.938|1.094||||||B/Victoria (Comorbidity Risk Score \<50)||1.094|0.938|
72578479|NCT05044195|144684412|OTHER||GMT ratio|0.706|||||TWO_SIDED|95.0|0.553|0.902||||||A/H1N1 (Comorbidity Risk Score ≥50)||0.902|0.553|
72578480|NCT05044195|144684412|OTHER||GMT ratio|0.734|||||TWO_SIDED|95.0|0.549|0.982||||||A/H3N2 (Comorbidity Risk Score ≥50)||0.982|0.549|
72578481|NCT05044195|144684412|OTHER||GMT ratio|0.773|||||TWO_SIDED|95.0|0.638|0.935||||||B/Yamagata (Comorbidity Risk Score ≥50)||0.935|0.638|
72578482|NCT05044195|144684412|OTHER||GMT ratio|0.905|||||TWO_SIDED|95.0|0.739|1.107||||||B/Victoria (Comorbidity Risk Score ≥50)||1.107|0.739|
72578483|NCT02585778|144684423|SUPERIORITY||LS Mean Difference|-47.8|||<|0.0001|TWO_SIDED|95.0|-60.7|-35.0||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab vs. Placebo|Alirocumab group was compared to placebo group using an appropriate contrast statement.||-35.0|-60.7|<0.0001
72578484|NCT02585778|144684423|SUPERIORITY||LS Mean Difference|-49.0|||<|0.0001|TWO_SIDED|95.0|-54.4|-43.6||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab vs. Placebo|Alirocumab group was compared to placebo group using an appropriate contrast statement.||-43.6|-54.4|<0.0001
72578485|NCT02585778|144684425|SUPERIORITY||LS Mean Difference|-50.6|||<|0.0001|TWO_SIDED|95.0|-63.4|-37.9||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab vs. Placebo|A hierarchical testing procedure was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when previous endpoint was statistically significant at 0.05 level. Hierarchical testing procedure was followed for T1DM and T2DM participants separately.||-37.9|-63.4|<0.0001
72578486|NCT02585778|144684425|SUPERIORITY||LS Mean Difference|-51.6|||<|0.0001|TWO_SIDED|95.0|-56.9|-46.4||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant in relevant diabetes stratum).||-46.4|-56.9|<0.0001
72578487|NCT02585778|144684426|SUPERIORITY||LS Mean Difference|-48.4|||<|0.0001|TWO_SIDED|95.0|-61.2|-35.5||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant in relevant diabetes stratum).||-35.5|-61.2|<0.0001
72578488|NCT02585778|144684426|SUPERIORITY||LS Mean Difference|-45.7|||<|0.0001|TWO_SIDED|95.0|-50.9|-40.4||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant in relevant diabetes stratum).||-40.4|-50.9|<0.0001
72578489|NCT02585778|144684427|SUPERIORITY||LS Mean Difference|-44.8|||<|0.0001|TWO_SIDED|95.0|-56.9|-32.8||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant in relevant diabetes stratum).||-32.8|-56.9|<0.0001
72578490|NCT02585778|144684427|SUPERIORITY||LS Mean Difference|-50.2|||<|0.0001|TWO_SIDED|95.0|-55.2|-45.3||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant in relevant diabetes stratum).||-45.3|-55.2|<0.0001
72543795|NCT01339910|144617539|SUPERIORITY||||||<|0.001||||||Test performed at a significance level of 0.05|Gray's test|||The null hypothesis is that there is no difference in the cumulative incidence of disease relapse during the first 18 months post-randomization between AML/MDS participants receiving MAC and RIC conditioning regimens. Cumulative incidence of disease relapse was compared between treatment arms using Gray's test, treating death as a competing risk.||||< 0.001
72543796|NCT01339910|144617540|SUPERIORITY|||||||0.002||||||Test performed at a significance level of 0.05|Gray's test|||The null hypothesis is that there is no difference in the cumulative incidence of treatment-related mortality during the first 18 months post-randomization between AML/MDS participants receiving MAC and RIC conditioning regimens. Cumulative incidence of treatment-related mortality was compared between treatment arms using Gray's test, treating disease relapse as a competing risk.||||0.002
72543797|NCT01339910|144617541|SUPERIORITY|||||||0.002||||||Test performed at a significance level of 0.05|Difference in Aalen-Johansen estimators|||The null hypothesis is that there is no difference in the cumulative incidence of neutrophil engraftment at Day 28 post-transplant between AML/MDS participants receiving MAC and RIC conditioning regimens. Cumulative incidence of neutrophil engraftment at Day 28 was compared between treatment arms using the difference in Aalen-Johansen estimators, which should be close to 0 under the null hypothesis. Death was treated as a competing risk.||||0.002
72543798|NCT01339910|144617541|SUPERIORITY|||||||0.065||||||Test performed at a significance level of 0.05|Difference in Aalen-Johansen estimators|||The null hypothesis is that there is no difference in the cumulative incidence of platelet engraftment at Day 60 post-transplant between AML/MDS participants receiving MAC and RIC conditioning regimens. Cumulative incidence of platelet engraftment at Day 60 was compared between treatment arms using the difference in Aalen-Johansen estimators, which should be close to 0 under the null hypothesis. Death was treated as a competing risk.||||0.065
72543799|NCT01339910|144617542|SUPERIORITY|||||||0.005||||||Test performed at a significance level of 0.05|Chi-squared|3 degrees of freedom||The null hypothesis is that there is no difference in the proportions of participants with full chimerism, mixed chimerism, graft rejection, and death prior to assessment at Day 28 post-transplant between AML/MDS participants receiving MAC and RIC conditioning regimens.||||0.005
72543800|NCT01339910|144617542|SUPERIORITY|||||||0.011||||||Test performed at a significance level of 0.05|Chi-squared|3 degrees of freedom||The null hypothesis is that there is no difference in the proportions of participants with full chimerism, mixed chimerism, graft rejection, and death prior to assessment at Day 100 post-transplant between AML/MDS participants receiving MAC and RIC conditioning regimens.||||0.011
72543801|NCT01339910|144617542|SUPERIORITY|||||||0.39||||||Test performed at a significance level of 0.05|Chi-squared|3 degrees of freedom||The null hypothesis is that there is no difference in the proportions of participants with full chimerism, mixed chimerism, graft rejection, and death prior to assessment at 18 months post-transplant between AML/MDS participants receiving MAC and RIC conditioning regimens.||||0.39
72543802|NCT01339910|144617543|SUPERIORITY|||||||0.024||||||Test performed at a significance level of 0.05|Gray's test|||The null hypothesis is that there is no difference in the cumulative incidence of grade II-IV acute GVHD during the first 100 days post-randomization between AML/MDS participants receiving MAC and RIC conditioning regimens. Cumulative incidence of grade II-IV acute GVHD was compared between treatment arms using Gray's test, treating death as a competing risk.||||0.024
72543803|NCT01339910|144617543|SUPERIORITY|||||||0.066||||||Test performed at a significance level of 0.05|Gray's test|||The null hypothesis is that there is no difference in the cumulative incidence of grade III-IV acute GVHD during the first 100 days post-randomization between AML/MDS participants receiving MAC and RIC conditioning regimens. Cumulative incidence of grade III-IV acute GVHD was compared between treatment arms using Gray's test, treating death as a competing risk.||||0.066
72543804|NCT01339910|144617544|SUPERIORITY|||||||0.019||||||Test performed at a significance level of 0.05|Gray's test|||The null hypothesis is that there is no difference in the cumulative incidence of chronic GVHD during the first 18 months post-randomization between AML/MDS participants receiving MAC and RIC conditioning regimens. Cumulative incidence of chronic GVHD was compared between treatment arms using Gray's test, treating death as a competing risk.||||0.019
72543805|NCT02555618|144617600|NON_INFERIORITY_OR_EQUIVALENCE|Non inferiority margin is set to -20%.|Rate difference|1.7|||||TWO_SIDED|95.0|-7.983|11.415|||||TAK-850 - Influenza HA Vaccine|The analysis is difference of seroconversion rate between treatment groups for A/H1N1 Strain-Day 22.||11.415|-7.983|
72543806|NCT02555618|144617600|NON_INFERIORITY_OR_EQUIVALENCE|Non inferiority margin is set to -20%.|Rate difference|-4.8|||||TWO_SIDED|95.0|-13.974|4.403|||||TAK-850 - Influenza HA Vaccine|The analysis is difference of seroconversion rate between treatment groups for A/H3N2 Strain-Day 22.||4.403|-13.974|
72543807|NCT02555618|144617600|NON_INFERIORITY_OR_EQUIVALENCE|Non inferiority margin is set to -20%.|Rate difference|2.6|||||TWO_SIDED|95.0|-6.082|11.32|||||TAK-850 - Influenza HA Vaccine|The analysis is difference of seroconversion rate between treatment groups for B Strain-Day 22.||11.320|-6.082|
72543808|NCT02555618|144617601|NON_INFERIORITY_OR_EQUIVALENCE|Non inferiority margin is set to 0.5.|Ratio of GMTs|0.99|||||TWO_SIDED|95.0|0.7984|1.2253|||||TAK-850/Influenza HA Vaccine|The analysis is Geometric Mean Ratio between treatment groups for A/H1N1 Strain-Day 22.||1.2253|0.7984|
72543809|NCT02555618|144617601|NON_INFERIORITY_OR_EQUIVALENCE|Non inferiority margin is set to 0.5.|Ratio of GMTs|0.76|||||TWO_SIDED|95.0|0.5544|1.05|||||TAK-850/Influenza HA Vaccine|The analysis is Geometric Mean Ratio between treatment groups for A/H3N2 Strain-Day 22.||1.0500|0.5544|
72543810|NCT02555618|144617601|NON_INFERIORITY_OR_EQUIVALENCE|Non inferiority margin is set to 0.5.|Ratio of GMTs|1.06|||||TWO_SIDED|95.0|0.8134|1.3931|||||TAK-850/Influenza HA Vaccine|The analysis is Geometric Mean Ratio between treatment groups for B Strain-Day 22.||1.3931|0.8134|
72543811|NCT02555618|144617604|NON_INFERIORITY_OR_EQUIVALENCE|Non inferiority margin is set to -20%.|Rate difference|6.8|||||TWO_SIDED|95.0|-3.02|16.348||||||The analysis is difference of seroconversion rate between treatment groups for A/H1N1 Strain-Day 22.||16.348|-3.020|
72543812|NCT02555618|144617604|NON_INFERIORITY_OR_EQUIVALENCE|Non inferiority margin is set to -20%.|Rate difference|-8.8|||||TWO_SIDED|95.0|-18.282|0.901||||||The analysis is difference of seroconversion rate between treatment groups for A/H3N2 Strain-Day 22.||0.901|-18.282|
72578491|NCT02585778|144684428|SUPERIORITY||LS Mean Difference|-42.7|||<|0.0001|TWO_SIDED|95.0|-54.9|-30.5||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant in relevant diabetes stratum).||-30.5|-54.9|<0.0001
72329482|NCT03037476|144184392|OTHER|General Linear Model|Slope|-0.0157||||0.743|TWO_SIDED|95.0|-0.1096|0.0782|||Mixed Models Analysis|Poisson regression||Change in MSLQ score at 6 month follow-up||0.0782|-0.1096|0.743
72543813|NCT02555618|144617604|NON_INFERIORITY_OR_EQUIVALENCE|Non inferiority margin is set to -20%.|Rate difference|-2.3|||||TWO_SIDED|95.0|-11.461|6.835||||||The analysis is difference of seroconversion rate between treatment groups for B Strain-Day 22.||6.835|-11.461|
72543814|NCT02555618|144617605|NON_INFERIORITY_OR_EQUIVALENCE|Non inferiority margin is set to 0.5.|Ratio of GMTs|1.05|||||TWO_SIDED|95.0|0.9559|1.1473|||||TAK-850/Influenza HA Vaccine|The analysis is Geometric Mean Ratio between treatment groups for A/H1N1 Strain-Day 22.||1.1473|0.9559|
72543815|NCT02555618|144617605|NON_INFERIORITY_OR_EQUIVALENCE|Non inferiority margin is set to 0.5.|Ratio of GMTs|0.9|||||TWO_SIDED|95.0|0.7862|1.0241|||||TAK-850/Influenza HA Vaccine|The analysis is Geometric Mean Ratio between treatment groups for A/H3N2 Strain-Day 22.||1.0241|0.7862|
72543816|NCT02555618|144617605|NON_INFERIORITY_OR_EQUIVALENCE|Non inferiority margin is set to 0.5.|Ratio of GMTs|0.98|||||TWO_SIDED|95.0|0.9273|1.0364|||||TAK-850/Influenza HA Vaccine|The analysis is Geometric Mean Ratio between treatment groups for B Strain-Day 22.||1.0364|0.9273|
72543817|NCT02555618|144617608|NON_INFERIORITY_OR_EQUIVALENCE|Non inferiority margin is set to -20%.|Rate difference|14.7|||||TWO_SIDED|95.0|5.489|23.577||||||The analysis is difference of seroconversion rate between treatment groups for A/H1N1 Strain-Day 22.||23.577|5.489|
72411257|NCT01418209|144330699|SUPERIORITY_OR_OTHER|||||||0.07||||||P-values from active treatment vs. placebo contrasts in a repeated measures linear model of outcome as a function of treatment arm, clinical site, week, and baseline outcome. The a priori threshold for statistical significance was 0.025.|repeated measures linear model|Robust standard errors were calculated using generalized estimating equations to account for within-participant correlation between repeated measures.||Outcome differences between active treatment and placebo||||0.07
72411258|NCT01418209|144330701|SUPERIORITY_OR_OTHER||||||<|0.001||||||P-values from active treatment vs. placebo contrasts in a repeated measures linear model of outcome as a function of treatment arm, clinical site, week, and baseline outcome. The a priori threshold for statistical significance was 0.025.|repeated measures linear model|Robust standard errors were calculated using generalized estimating equations to account for within-participant correlation between repeated measures.||Outcome differences between active treatment and placebo.||||<0.001
72411259|NCT01418209|144330701|SUPERIORITY_OR_OTHER|||||||0.03||||||P-values from active treatment vs. placebo contrasts in a repeated measures linear model of outcome as a function of treatment arm, clinical site, week, and baseline outcome. The a priori threshold for statistical significance was 0.025.|repeated measures linear model|Robust standard errors were calculated using generalized estimating equations to account for within-participant correlation between repeated measures.||Outcome differences between active treatment and placebo||||0.03
72411260|NCT04737538|144330703|OTHER||Mean Difference (Final Values)|-11.0|STANDARD_ERROR_OF_MEAN|1.12|<|0.0001|TWO_SIDED|95.0|-13.3|-8.8|||Non-parametric method (Van Elteren test)|||||-8.8|-13.3|<0.0001
72411261|NCT04737538|144330704|OTHER||Mean Difference (Final Values)|0.4|STANDARD_ERROR_OF_MEAN|1.01||0.4488|TWO_SIDED|95.0|-1.6|2.4|||Non-parametric method (Van Elteren test)|||||2.4|-1.6|0.4488
72543818|NCT02555618|144617608|NON_INFERIORITY_OR_EQUIVALENCE|Non inferiority margin is set to -20%.|Rate difference|-1.9|||||TWO_SIDED|95.0|-10.614|6.928||||||The analysis is difference of seroconversion rate between treatment groups for A/H3N2 Strain-Day 22.||6.928|-10.614|
72543819|NCT02555618|144617608|NON_INFERIORITY_OR_EQUIVALENCE|Non inferiority margin is set to -20%.|Rate difference|-2.4|||||TWO_SIDED|95.0|-10.346|5.579||||||The analysis is difference of seroconversion rate between treatment groups for B-Strain.||5.579|-10.346|
72543820|NCT02555618|144617609|NON_INFERIORITY_OR_EQUIVALENCE|Non inferiority margin is set to 0.5.|Ratio of GMTs|1.48|||||TWO_SIDED|95.0|1.1221|1.9623|||||TAK-850/Influenza HA Vaccine|The analysis is Geometric Mean Ratio between treatment groups for A/H1N1 Strain-Day 22.||1.9623|1.1221|
72411262|NCT04737538|144330705|OTHER||Mean Difference (Final Values)|-11.5|STANDARD_ERROR_OF_MEAN|1.18|<|0.0001|TWO_SIDED|95.0|-13.8|-9.1|||Non-parametric method (Van Elteren test)|||||-9.1|-13.8|<0.0001
72543821|NCT02555618|144617609|NON_INFERIORITY_OR_EQUIVALENCE|Non inferiority margin is set to 0.5.|Ratio of GMTs|1.07|||||TWO_SIDED|95.0|0.7806|1.4564|||||TAK-850/Influenza HA Vaccine|The analysis is Geometric Mean Ratio between treatment groups for A/H3N2 Strain-Day 22.||1.4564|0.7806|
72543822|NCT02555618|144617609|NON_INFERIORITY_OR_EQUIVALENCE|Non inferiority margin is set to 0.5.|Ratio of GMTs|1.07|||||TWO_SIDED|95.0|0.8166|1.3934|||||TAK-850/Influenza HA Vaccine|The analysis is Geometric Mean Ratio between treatment groups for B Strain-Day 22.||1.3934|0.8166|
72578492|NCT02585778|144684428|SUPERIORITY||LS Mean Difference|-44.1|||<|0.0001|TWO_SIDED|95.0|-49.0|-39.2||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant in relevant diabetes stratum).||-39.2|-49.0|<0.0001
72578493|NCT02585778|144684429|SUPERIORITY||LS Mean Difference|-42.7|||<|0.0001|TWO_SIDED|95.0|-54.2|-31.3||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant in relevant diabetes stratum).||-31.3|-54.2|<0.0001
72578494|NCT02585778|144684429|SUPERIORITY||LS Mean Difference|-38.7|||<|0.0001|TWO_SIDED|95.0|-43.4|-33.9||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant in relevant diabetes stratum).||-33.9|-43.4|<0.0001
72578495|NCT02585778|144684430|SUPERIORITY||LS Mean Difference|-39.0|||<|0.0001|TWO_SIDED|95.0|-49.4|-28.7||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant in relevant diabetes stratum).||-28.7|-49.4|<0.0001
72578496|NCT02585778|144684430|SUPERIORITY||LS Mean Difference|-36.7|||<|0.0001|TWO_SIDED|95.0|-40.9|-32.5||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant in relevant diabetes stratum).||-32.5|-40.9|<0.0001
72578497|NCT02585778|144684431|SUPERIORITY||LS Mean Difference|-29.2|||<|0.0001|TWO_SIDED|95.0|-37.8|-20.7||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant in relevant diabetes stratum).||-20.7|-37.8|<0.0001
72578498|NCT02585778|144684431|SUPERIORITY||LS Mean Difference|-27.6|||<|0.0001|TWO_SIDED|95.0|-31.2|-24.1||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant in relevant diabetes stratum).||-24.1|-31.2|<0.0001
72578499|NCT02585778|144684432|SUPERIORITY||Odds Ratio (OR)|117.0|||<|0.0001|TWO_SIDED|95.0|13.1|1041.8||Threshold for significance at 0.05 level.|Regression, Logistic|Multiple imputation approach followed by logistic regression model.|Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant in relevant diabetes stratum).||1041.8|13.1|<0.0001
72578500|NCT02585778|144684432|SUPERIORITY||Odds Ratio (OR)|84.6|||<|0.0001|TWO_SIDED|95.0|36.5|196.1||Threshold for significance at 0.05 level|Regression, Logistic|Multiple imputation approach followed by logistic regression model.|Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant in relevant diabetes stratum).||196.1|36.5|<0.0001
72411263|NCT01312467|144330734|SUPERIORITY_OR_OTHER||||||>|0.773|TWO_SIDED||||||A paired t-test|||||||> 0.773
72411264|NCT00560833|144330807|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.4|||<|0.01|TWO_SIDED|95.0|-2.3|-0.4||Dunnet-adjusted from ANCOVA with factors for treatment and (pooled) center and a covariate for baseline value.|ANCOVA|||||-0.4|-2.3|<0.01
72543823|NCT02555618|144617612|NON_INFERIORITY_OR_EQUIVALENCE|Non inferiority margin is set to -20%.|Rate difference|1.1|||||TWO_SIDED|95.0|-7.195|9.423|||||TAK-850 - Influenza HA Vaccine|The analysis is difference of seroconversion rate between treatment groups for A/H1N1 Strain-Day 22.||9.423|-7.195|
72543824|NCT02555618|144617612|NON_INFERIORITY_OR_EQUIVALENCE|Non inferiority margin is set to -20%.|Rate difference|-0.8|||||TWO_SIDED|95.0|-10.369|8.803|||||TAK-850 - Influenza HA Vaccine|The analysis is difference of seroconversion rate between treatment groups for A/H3N2 Strain-Day 22.||8.803|-10.369|
72543825|NCT02555618|144617612|NON_INFERIORITY_OR_EQUIVALENCE|Non inferiority margin is set to -20%.|Rate difference|3.2|||||TWO_SIDED|95.0|-6.406|12.757|||||TAK-850 - Influenza HA Vaccine|The analysis is difference of seroconversion rate between treatment groups for B Strain-Day 22.||12.757|-6.406|
72543826|NCT02555618|144617613|NON_INFERIORITY_OR_EQUIVALENCE|Non inferiority margin is set to 0.5.|Ratio of GMTs|1.07|||||TWO_SIDED|95.0|0.9106|1.2484|||||TAK-850/Influenza HA Vaccine|The analysis is Geometric Mean Ratio between treatment groups for A/H1N1 Strain-Day 22.||1.2484|0.9106|
72543827|NCT02555618|144617613|NON_INFERIORITY_OR_EQUIVALENCE|Non inferiority margin is set to 0.5.|Ratio of GMTs|0.98|||||TWO_SIDED|95.0|0.8686|1.0969|||||TAK-850/Influenza HA Vaccine|The analysis is Geometric Mean Ratio between treatment groups for A/H3N2-Day 22.||1.0969|0.8686|
72543828|NCT02555618|144617613|NON_INFERIORITY_OR_EQUIVALENCE|Non inferiority margin is set to 0.5.|Ratio of GMTs|1.05|||||TWO_SIDED|95.0|0.9622|1.1427|||||TAK-850/Influenza HA Vaccine|The analysis is Geometric Mean Ratio between treatment groups for B Strain-Day 22.||1.1427|0.9622|
72543829|NCT02063698|144617619|SUPERIORITY|||||||1|||||||Fisher Exact|||Day 2: BPI Worst Pain Past 24 Hours||||1.0
72543830|NCT02063698|144617619|SUPERIORITY|||||||0.45|||||||Fisher Exact|||Day 3: BPI Worst Pain Past 24 Hours||||0.45
72543831|NCT02063698|144617619|SUPERIORITY|||||||0.38|||||||Fisher Exact|||Day 4: BPI Worst Pain Past 24 Hours||||0.38
72543832|NCT02063698|144617619|SUPERIORITY|||||||0.12|||||||Fisher Exact|||Day 5: BPI Worst Pain Past 24 Hours||||0.12
72543833|NCT02063698|144617619|SUPERIORITY|||||||0.7|||||||Fisher Exact|||Day 6: BPI Worst Pain Past 24 Hours||||0.70
72543834|NCT02063698|144617619|SUPERIORITY|||||||1|||||||Fisher Exact|||Day 7: BPI Worst Pain Past 24 Hours||||1.0
72578501|NCT02585778|144684433|SUPERIORITY||Odds Ratio (OR)|52.9|||<|0.0001|TWO_SIDED|95.0|16.6|168.3||Threshold for significance at 0.05 level.|Regression, Logistic|Multiple imputation approach followed by logistic regression model.|Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||168.3|16.6|<0.0001
72578502|NCT02585778|144684434|SUPERIORITY||Odds Ratio (OR)|33.2|||<|0.0001|TWO_SIDED|95.0|8.0|137.4||Threshold for significance at 0.05 level.|Regression, Logistic|Multiple imputation approach followed by logistic regression model.|Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant in relevant diabetes stratum).||137.4|8.0|<0.0001
72411265|NCT00560833|144330807|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.2|||<|0.01|TWO_SIDED|95.0|-3.1|-1.2||Dunnet-adjusted from ANCOVA with factors for treatment and (pooled) center and a covariate for baseline value.|ANCOVA|||||-1.2|-3.1|<0.01
72411266|NCT00560833|144330807|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.9|||<|0.01|TWO_SIDED|95.0|-2.9|-1.0||Dunnet-adjusted from ANCOVA with factors for treatment and (pooled) center and a covariate for baseline value.|ANCOVA|||||-1.0|-2.9|<0.01
72543835|NCT02063698|144617619|SUPERIORITY|||||||0.44|||||||Fisher Exact|||Day 8: BPI Worst Pain Past 24 Hours||||0.44
72543836|NCT02063698|144617620|SUPERIORITY|||||||0.44|||||||Equal variance t-test|||||||0.44
72543837|NCT02063698|144617621|SUPERIORITY|||||||0.13|||||||Equal variance t-test|||||||0.13
72543838|NCT02063698|144617623|SUPERIORITY|||||||0.025|||||||Chi-squared|||||||0.025
72543839|NCT02063698|144617624|SUPERIORITY|||||||0.01|||||||Chi-squared|||||||0.01
72543840|NCT02063698|144617625|SUPERIORITY|||||||0.02|||||||Chi-squared|||||||0.02
72543841|NCT02063698|144617626|SUPERIORITY|||||||0.01|||||||Chi-squared|||||||0.01
72543842|NCT02063698|144617627|SUPERIORITY|||||||0.04|||||||Chi-squared|||||||0.04
72543843|NCT02741271|144617635|SUPERIORITY||LSM Difference|5.21|||<|0.001|TWO_SIDED|95.0|3.21|7.2|||cLDA with multiple imputation|Primary Analysis Method, using the constrained Longitudinal Data Analysis (cLDA) model for missing data|Between-Treatment Difference|||7.20|3.21|<0.001
72543844|NCT02741271|144617638|SUPERIORITY||LSM Difference|6.05|||<|0.001|TWO_SIDED|95.0|3.53|8.56|||cLDA with multiple imputation|Primary Analysis Method|Between-Treatment Difference at 4 hr Post-Dose|||8.56|3.53|<0.001
72543845|NCT02741271|144617638|SUPERIORITY||LSM Difference|7.04|||<|0.001|TWO_SIDED|95.0|4.74|9.35|||cLDA with multiple imputation|Primary Analysis Method|Between-Treatment Difference at 2 hr Post-Dose|||9.35|4.74|<0.001
72543846|NCT02741271|144617638|SUPERIORITY||LSM Difference|6.19|||<|0.001|TWO_SIDED|95.0|4.09|8.28|||cLDA with multiple imputation|Primary Analysis Method|Between-Treatment Difference at 60 min Post-Dose|||8.28|4.09|<0.001
72543847|NCT02741271|144617638|SUPERIORITY||LSM Difference|6.89|||<|0.001|TWO_SIDED|95.0|5.1|8.67|||cLDA with multiple imputation|Primary Analysis Method|Between-Treatment Difference at 30 min Post-Dose|||8.67|5.10|<0.001
72543848|NCT02741271|144617638|SUPERIORITY||LSM Difference|6.64|||<|0.001|TWO_SIDED|95.0|4.89|8.39|||cLDA with multiple imputation|Primary Analysis Method|Between-Treatment Difference at 15 min Post-Dose|||8.39|4.89|<0.001
72543849|NCT02741271|144617638|SUPERIORITY||LSM Difference|4.2|||<|0.001|TWO_SIDED|95.0|2.5|5.91|||cLDA with multiple imputation|Primary Analysis Method|Between-Treatment Difference at 5 min Post-Dose|||5.91|2.50|<0.001
72543850|NCT02741271|144617639|SUPERIORITY||LSM Difference|6.32|||<|0.001|TWO_SIDED|95.0|4.36|8.27|||cLDA|Secondary Outcome Measure on Day 1|Between-Treatment Difference at 4 hr Post-Dose|||8.27|4.36|<0.001
72543851|NCT02741271|144617639|SUPERIORITY||LSM Difference|3.33||||0.026|TWO_SIDED|95.0|0.41|6.26|||cLDA|Secondary Outcome Measure at Week 12|Between-Treatment Difference at 4 hr Post-Dose|||6.26|0.41|0.026
72543852|NCT02741271|144617640|SUPERIORITY||LSM Difference|1.63||||0.197|TWO_SIDED|95.0|-0.85|4.11|||cLDA|Secondary Outcome Measure|Between-Treatment Difference|||4.11|-0.85|0.197
72543853|NCT00410410|144617650|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.73||||0.124|TWO_SIDED|95.0|0.48|1.09||Cochran-Mantel-Haenszel Chi square p-value and RR along with 95% confidence interval provided, adjusting for randomization strata (whether a participant had an inadequate response and/or intolerance to anti-TNF therapy).|Cochran-Mantel-Haenszel|Conditional on ABA 30/\~10 mg/kg vs PLA comparison being statistically significant at 5% level, ABA \~10 vs PLA to be tested at 5% significance level.||Null hypothesis=no treatment difference between ABA arm and placebo (PLA) arm. ABA 30/\~10 mg/kg vs PLA: power=98%, sample size=140 per arm,expected PLA response rate=40%, ABA 30/\~10 mg/kg=65%. ABA \~10 mg/kg vs. PLA: power=90%, sample size=140 per arm, 5% significance; expected PLA response rate= 40%, ABA \~10=60%.||1.09|0.48|0.124
72543854|NCT00410410|144617652|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.2|||||TWO_SIDED|95.0|0.06|0.67||Cochran-Mantel-Haenszel Chi square p-value and RR along with 95% confidence interval provided, adjusting for randomization strata.|Cochran-Mantel-Haenszel|Conditional on ABA 30/\~10 vs PLA comparison for clinical response being significant at 5% level, this comparison for remission will be tested at 5%.|Conditional on both the remission comparison for ABA 30/\~10 vs PLA, and the clinical response comparison for ABA\~10 vs PLA being significant at 5%, the secondary remission comparison for ABA \~10 vs PLA will be tested at 5%.|Null hypothesis=no treatment difference between each of the ABA and placebo (PLA). At 5% significance level, Aba 30/\~10 vs. PLA: power=96%, sample size=140 per arm, expected PLA rate=15%. ABA 30/\~10 =35%; Aba \~10 vs. PLA: power=82%, sample size=140 per arm, expected PLA response rate= 15%, ABA/\~10 mg/kg=30%||0.67|.06|
72543855|NCT00410410|144617653|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.66|||||TWO_SIDED|95.0|0.42|1.05||Cochran-Mantel-Haenszel Chi square p-value and RR along with 95% confidence interval provided, adjusting for randomization strata.|Cochran-Mantel-Haenszel|If ABA 30/\~10 vs PLA remission comparison is significant at 5% level, the mucosal healing comparison for the same treatment group will be tested at 5%|Conditional on both the comparison for mucosal healing for ABA 30/\~10 vs PLA and the comparison for remission for ABA \~10 vs. PLA being significant, the comparison for mucosal healing for ABA \~10 vs PLA will be tested at 5%.|Null hypothesis=no treatment difference (relative risk \[RR\] of ABA over placebo=1) for mucosal healing. ABA 30/\~10 vs. placebo: power=99%, sample size=140 per arm, expected PLA response rate=30%, ABA 30/\~10 mg/kg=60%. ABA \~10 vs. placebo: power=98%, sample size=140 per arm, 5% significance; expected PLA response rate= 30%, ABA \~10 mg/kg=55%||1.05|0.42|
72543856|NCT00410410|144617654|SUPERIORITY_OR_OTHER|||||||0.044||||||All statistical testing was performed at a pre-specified alpha-level of 5%.|Cochran-Armitage Trend Test|||The Cochran-Armitage trend test was performed to evaluate whether a relationship existed between the response and dose regimen by comparing the proportion of participants in response across all four treatment arms.||||0.044
72543857|NCT00410410|144617660|SUPERIORITY_OR_OTHER|||||||0.149||||||All statistical testing was performed at a pre-specified alpha-level of 5%|Cochran-Armitage Trend Test|||The Cochran-Armitage trend test was performed to evaluate whether a relationship existed between the response and dose regimen by comparing the proportion of participants in response across all four treatment arms. Normal approximation was used if the number of responses in a treatment group is at least 5. Otherwise an exact method was used.||||0.149
72543858|NCT02868281|144617717|OTHER||Odds Ratio (OR)|7.87||||0.027|TWO_SIDED|95.0|1.29|48.11|||Mixed effect logistic regression||The model included treatment, Baseline ACT total score, Baseline ACT total score squared, center, type of Baseline controller, gender and age, with the center as a random factor.|||48.11|1.29|0.027
72543859|NCT02868281|144617718|OTHER||Difference in Least Squares Mean|-0.1||||0.222|TWO_SIDED|95.0|-0.2|0.0|||Mixed Model Repeat Measures||Weeks 1-4. The model included covariates of treatment, center, Baseline ACT total score, type of Baseline controller, gender, age and treatment-by-visit interaction, with the center as a random factor.|||0.0|-0.2|0.222
72543860|NCT02868281|144617718|OTHER||Difference in Least Squares Mean|-0.1||||0.156|TWO_SIDED|95.0|-0.2|0.0|||Mixed Model Repeat Measures||Weeks 5-8. The model included covariates of treatment, center, Baseline ACT total score, type of Baseline controller, gender, age and treatment-by-visit interaction, with the center as a random factor.|||0.0|-0.2|0.156
72543861|NCT02868281|144617718|OTHER||Difference in Least Squares Mean|-0.1||||0.245|TWO_SIDED|95.0|-0.2|0.0|||Mixed Model Repeat Measures||Weeks 9-12. The model included covariates of treatment, center, Baseline ACT total score, type of Baseline controller, gender, age and treatment-by-visit interaction, with the center as a random factor.|||0.0|-0.2|0.245
72543862|NCT02868281|144617718|OTHER||Difference in Least Squares Mean|-0.1||||0.057|TWO_SIDED|95.0|-0.2|0.0|||Mixed Model Repeat Measures||Weeks 13-16. The model included covariates of treatment, center, Baseline ACT total score, type of Baseline controller, gender, age and treatment-by-visit interaction, with the center as a random factor.|||0.0|-0.2|0.057
72543863|NCT02868281|144617718|OTHER||Difference in Least Squares Mean|-0.1||||0.151|TWO_SIDED|95.0|-0.2|0.0|||Mixed Model Repeat Measures||Weeks 17-20. The model included covariates of treatment, center, Baseline ACT total score, type of Baseline controller, gender, age and treatment-by-visit interaction, with the center as a random factor.|||0.0|-0.2|0.151
72578503|NCT02585778|144684434|SUPERIORITY||Odds Ratio (OR)|27.1|||<|0.0001|TWO_SIDED|95.0|14.2|51.5||Threshold for significance at 0.05 level.|Regression, Logistic|Multiple imputation approach followed by logistic regression model.|Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant in relevant diabetes stratum).||51.5|14.2|<0.0001
72578504|NCT02585778|144684435|SUPERIORITY||Odds Ratio (OR)|55.5||||0.0002|TWO_SIDED|95.0|6.5|473.7||Threshold for significance at 0.05 level.|Regression, Logistic|Multiple imputation approach followed by logistic regression model.|Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant in relevant diabetes stratum).||473.7|6.5|0.0002
72578505|NCT02585778|144684435|SUPERIORITY||Odds Ratio (OR)|103.3|||<|0.0001|TWO_SIDED|95.0|24.6|433.1||Threshold for significance at 0.05 level.|Regression, Logistic|Multiple imputation approach followed by logistic regression model.|Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant in relevant diabetes stratum).||433.1|24.6|<0.0001
72578506|NCT02585778|144684436|SUPERIORITY||Adjusted Mean Difference|-18.7||||0.0039|TWO_SIDED|95.0|-31.4|-6.0||Threshold for significance at 0.05 level.|Regression, Robust|Multiple imputation approach followed by robust regression model.|Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant in relevant diabetes stratum).||-6.0|-31.4|0.0039
72411267|NCT00560833|144330807|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.9|||<|0.01|TWO_SIDED|95.0|-2.9|-1.0||Dunnet-adjusted from ANCOVA with factors for treatment and (pooled) center and a covariate for baseline value.|ANCOVA|||||-1.0|-2.9|<0.01
72411268|NCT00560833|144330809|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0||||0.06|TWO_SIDED|95.0|-2.0|0.0||Dunnet-adjusted from ANCOVA with factors for treatment and (pooled) center and a covariate for baseline value.|ANCOVA|||||0.0|-2.0|0.06
72411269|NCT00560833|144330809|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.0|||<|0.01|TWO_SIDED|95.0|-3.0|-0.9||Dunnet-adjusted from ANCOVA with factors for treatment and (pooled) center and a covariate for baseline value.|ANCOVA|||||-0.9|-3.0|<0.01
72411270|NCT00560833|144330809|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.9|||<|0.01|TWO_SIDED|95.0|-2.9|-0.9||Dunnet-adjusted from ANCOVA with factors for treatment and (pooled) center and a covariate for baseline value.|ANCOVA|||||-0.9|-2.9|<0.01
72411271|NCT00560833|144330809|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.5|||<|0.01|TWO_SIDED|95.0|-2.6|-0.5||Dunnet-adjusted from ANCOVA with factors for treatment and (pooled) center and a covariate for baseline value.|ANCOVA|||||-0.5|-2.6|<0.01
72411272|NCT00560833|144330810|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.03||||0.62|TWO_SIDED|95.0|-0.09|0.03||Dunnet-adjusted from ANCOVA with factors for treatment and (pooled) center and a covariate for baseline value.|ANCOVA|||||0.03|-0.09|0.62
72543864|NCT02868281|144617718|OTHER||Difference in Least Squares Mean|-0.1||||0.114|TWO_SIDED|95.0|-0.2|0.0|||Mixed Model Repeat Measures||Weeks 21-24. The model included covariates of treatment, center, Baseline ACT total score, type of Baseline controller, gender, age and treatment-by-visit interaction, with the center as a random factor.|||0.0|-0.2|0.114
72411273|NCT00560833|144330810|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.06||||0.02|TWO_SIDED|95.0|-0.12|-0.01||Dunnet-adjusted from ANCOVA with factors for treatment and (pooled) center and a covariate for baseline value.|ANCOVA|||||-0.01|-0.12|0.02
72411274|NCT00560833|144330810|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.07||||0.01|TWO_SIDED|95.0|-0.13|-0.01||Dunnet-adjusted from ANCOVA with factors for treatment and (pooled) center and a covariate for baseline value.|ANCOVA|||||-0.01|-0.13|0.01
72411275|NCT00560833|144330810|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.06||||0.02|TWO_SIDED|95.0|-0.12|-0.01||Dunnet-adjusted from ANCOVA with factors for treatment and (pooled) center and a covariate for baseline value.|ANCOVA|||||-0.01|-0.12|0.02
72543865|NCT02868281|144617719|OTHER||Difference in Least Squares Mean|-0.05||||0.487|TWO_SIDED|95.0|-0.18|0.09|||Mixed Model Repeat Measures||Weeks 1-4. The model included covariates of treatment, center, Baseline ACT total score, type of Baseline controller, gender, age and treatment-by-visit interaction, with the center as a random factor.|||0.09|-0.18|0.487
72543866|NCT02868281|144617719|OTHER||Difference in Least Squares Mean|-0.04||||0.546|TWO_SIDED|95.0|-0.16|0.09|||Mixed Model Repeat Measures||Weeks 5-8. The model included covariates of treatment, center, Baseline ACT total score, type of Baseline controller, gender, age and treatment-by-visit interaction, with the center as a random factor.|||0.09|-0.16|0.546
72543867|NCT02868281|144617719|OTHER||Difference in Least Squares Mean|-0.06||||0.314|TWO_SIDED|95.0|-0.17|0.06|||Mixed Model Repeat Measures||Weeks 9-12. The model included covariates of treatment, center, Baseline ACT total score, type of Baseline controller, gender, age and treatment-by-visit interaction, with the center as a random factor.|||0.06|-0.17|0.314
72543868|NCT02868281|144617719|OTHER||Difference in Least Squares Mean|-0.07||||0.197|TWO_SIDED|95.0|-0.19|0.04|||Mixed Model Repeat Measures||Weeks 13-16. The model included covariates of treatment, center, Baseline ACT total score, type of Baseline controller, gender, age and treatment-by-visit interaction, with the center as a random factor.|||0.04|-0.19|0.197
72543869|NCT02868281|144617719|OTHER||Difference in Least Squares Mean|-0.06||||0.282|TWO_SIDED|95.0|-0.17|0.06|||Mixed Model Repeat Measures||Weeks 17-20. The model included covariates of treatment, center, Baseline ACT total score, type of Baseline controller, gender, age and treatment-by-visit interaction, with the center as a random factor.|||0.06|-0.17|0.282
72543870|NCT02868281|144617719|OTHER||Difference in Least Squares Mean|-0.03||||0.543|TWO_SIDED|95.0|-0.15|0.08|||Mixed Model Repeat Measures||Weeks 21-24. The model included covariates of treatment, center, Baseline ACT total score, type of Baseline controller, gender, age and treatment-by-visit interaction, with the center as a random factor.|||0.08|-0.15|0.543
72543871|NCT02868281|144617720|OTHER||Difference in Least Squares Mean|0.06||||0.273|TWO_SIDED|95.0|-0.059|0.18|||Mixed Model Repeat Measures||The model included covariates of treatment, center, Baseline FEV1, type of Baseline controller, gender and age, with the center as a random factor.|||0.180|-0.059|0.273
72578507|NCT02585778|144684436|SUPERIORITY||Adjusted Mean Difference|-18.4|||<|0.0001|TWO_SIDED|95.0|-23.7|-13.2||Threshold for significance at 0.05 level.|Regression, Robust|Multiple imputation approach followed by robust regression model.|Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant in relevant diabetes stratum).||-13.2|-23.7|<0.0001
72578508|NCT02585778|144684437|SUPERIORITY||LS Mean Difference|3.9||||0.3434|TWO_SIDED|95.0|-4.2|12.0||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant in relevant diabetes stratum).||12.0|-4.2|0.3434
72578509|NCT02585778|144684437|SUPERIORITY||LS Mean Difference|4.4||||0.01|TWO_SIDED|95.0|1.1|7.7||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant in relevant diabetes stratum).||7.7|1.1|0.0100
72411276|NCT00560833|144330811|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01||||1|TWO_SIDED|95.0|-0.06|0.07||Dunnet-adjusted from ANCOVA with factors for treatment and (pooled) center and a covariate for baseline value.|ANCOVA|||||0.07|-0.06|1.0
72543872|NCT02868281|144617721|OTHER||Difference in Least Squares Mean|-12.0||||0.367|TWO_SIDED|95.0|-40.3|16.3|||Mixed Model Repeat Measures||Weeks 1-4. The model included covariates of treatment, center, Baseline ACT total score, type of Baseline controller, gender, age and treatment-by-visit interaction, with the center as a random factor.|||16.3|-40.3|0.367
72543873|NCT02868281|144617721|OTHER||Difference in Least Squares Mean|-7.2||||0.587|TWO_SIDED|95.0|-35.5|21.2|||Mixed Model Repeat Measures||Weeks 5-8. The model included covariates of treatment, center, Baseline ACT total score, type of Baseline controller, gender, age and treatment-by-visit interaction, with the center as a random factor.|||21.2|-35.5|0.587
72578510|NCT02585778|144684438|SUPERIORITY||Adjusted Mean Difference|-5.7||||0.0902|TWO_SIDED|95.0|-12.3|0.9||Threshold for significance at 0.05 level.|Regression, Robust|Multiple imputation approach followed by robust regression model.|Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant in relevant diabetes stratum).||0.9|-12.3|0.0902
72578511|NCT01044264|144684515|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|BE of the test to reference in the per protocol population|Wilcoxon Rank Sum Test|100.0|||||TWO_SIDED|90.0|92.47|113.54|||Wilcoxon Rank Sum Test|||||113.54|92.47|
72578512|NCT01685840|144684519|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.98||||0.88|TWO_SIDED|95.0|0.79|1.22||A sample size of 1100 patients was expected to provide approximately 90% power to detect a difference in the primary endpoint with an assumed type I error rate of 0.05, 2-sided. Analysis was adjusted for age, sex, ejection fraction, NT-proBNP and DM.|Regression, Cox|||||1.22|0.79|0.88
72578513|NCT01685840|144684520|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.86||||0.37|TWO_SIDED|95.0|0.62|1.2|||Regression, Cox|||||1.20|0.62|0.37
72578514|NCT01685840|144684521|SUPERIORITY_OR_OTHER||Mean Difference (Net)|9.0||||0.53|TWO_SIDED|95.0|-20.0|39.0|||Bang-Tsiatis Partitioned Estimator|||||39|-20|0.53
72578515|NCT01685840|144684522|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.94||||0.75|TWO_SIDED|95.0|0.65|1.37|||Regression, Cox|||||1.37|0.65|0.75
72578516|NCT01685840|144684523|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.04||||0.76|TWO_SIDED|95.0|0.82|1.31|||Regression, Cox|||||1.31|0.82|0.76
72578517|NCT01685840|144684524|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.29||||0.08|TWO_SIDED|95.0|0.97|1.72|||Anderson-Gill Intensity Model|||||1.72|0.97|0.08
72578518|NCT01685840|144684525|SUPERIORITY|||||||0.636|||||||Mixed Models Analysis|||Baseline||||0.636
72578519|NCT01685840|144684525|SUPERIORITY|||||||0.628|||||||Mixed Models Analysis|||3 month||||0.628
72329483|NCT03037476|144184392|OTHER|General Linear Model|Slope|0.0133||||0.784|TWO_SIDED|95.0|-0.0816|0.1081|||Mixed Models Analysis|Poisson regression||Change in MSLQ score at 12 month follow up||0.1081|-0.0816|0.784
72578520|NCT01685840|144684525|SUPERIORITY|||||||0.586|||||||Mixed Models Analysis|||6 month||||0.586
72578521|NCT01685840|144684525|SUPERIORITY|||||||0.669|||||||Mixed Models Analysis|||12 month||||0.669
72411277|NCT00560833|144330811|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.03||||0.72|TWO_SIDED|95.0|-0.09|0.04||Dunnet-adjusted from ANCOVA with factors for treatment and (pooled) center and a covariate for baseline value.|ANCOVA|||||0.04|-0.09|0.72
72578522|NCT01685840|144684525|SUPERIORITY|||||||0.949|||||||Mixed Models Analysis|||24 month||||0.949
72578523|NCT01685840|144684526|SUPERIORITY||Mean Difference (Final Values)|0.88||||0.404|TWO_SIDED|95.0|-1.188|2.947||Adjusted P-value|Mixed Models Analysis|||3 month||2.947|-1.188|0.404
72578524|NCT01685840|144684526|SUPERIORITY||Mean Difference (Final Values)|1.478||||0.219|TWO_SIDED|95.0|-0.881|3.836||Adjusted P-value|Mixed Models Analysis|||6 month||3.836|-0.881|0.219
72578525|NCT01685840|144684526|SUPERIORITY||Mean Difference (Final Values)|2.099||||0.104|TWO_SIDED|95.0|-0.433|4.63||Adjusted P-value|Mixed Models Analysis|||12 month||4.630|-0.433|0.104
72578526|NCT01685840|144684526|SUPERIORITY||Mean Difference (Final Values)|1.999||||0.228|TWO_SIDED|95.0|-1.253|5.25|||Mixed Models Analysis|||24 month||5.250|-1.253|0.228
72578527|NCT01685840|144684527|SUPERIORITY||Mean Difference (Final Values)|0.017||||0.421|TWO_SIDED|95.0|-0.025|0.06||Adjusted P-value|Mixed Models Analysis|||3 month||0.060|-0.025|0.421
72578528|NCT01685840|144684527|SUPERIORITY||Mean Difference (Final Values)|0.028||||0.239|TWO_SIDED|95.0|-0.018|0.074||Adjusted P-value|Mixed Models Analysis|||6 month||0.074|-0.018|0.239
72578529|NCT01685840|144684527|SUPERIORITY||Mean Difference (Final Values)|0.021||||0.402|TWO_SIDED|95.0|-0.028|0.07|||Mixed Models Analysis|||12 month||0.070|-0.028|0.402
72578530|NCT01685840|144684527|SUPERIORITY||Mean Difference (Final Values)|0.009||||0.78|TWO_SIDED|95.0|-0.057|0.076||Adjusted P-value|Mixed Models Analysis|||24 month||0.076|-0.057|0.780
72578531|NCT01685840|144684528|SUPERIORITY||Mean Difference (Final Values)|-2.131||||0.268|TWO_SIDED|95.0|-5.902|1.64||Adjusted P-value|Mixed Models Analysis|||3 month||1.640|-5.902|0.268
72578532|NCT01685840|144684528|SUPERIORITY||Mean Difference (Final Values)|1.069||||0.599|TWO_SIDED|95.0|-2.921|5.058|||Mixed Models Analysis|||6 month||5.058|-2.921|0.599
72578533|NCT01685840|144684528|SUPERIORITY||Mean Difference (Final Values)|-0.389||||0.852|TWO_SIDED|95.0|-4.486|3.707||Adjusted P-value|Mixed Models Analysis|||12 month||3.707|-4.486|0.852
72543874|NCT02868281|144617721|OTHER||Difference in Least Squares Mean|-4.7||||0.721|TWO_SIDED|95.0|-33.1|23.7|||Mixed Model Repeat Measures||Weeks 9-12. The model included covariates of treatment, center, Baseline ACT total score, type of Baseline controller, gender, age and treatment-by-visit interaction, with the center as a random factor.|||23.7|-33.1|0.721
72411278|NCT00560833|144330811|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.06||||0.13|TWO_SIDED|95.0|-0.12|0.01||Dunnet-adjusted from ANCOVA with factors for treatment and (pooled) center and a covariate for baseline value.|ANCOVA|||||0.01|-0.12|0.13
72411279|NCT00560833|144330811|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.05||||0.15|TWO_SIDED|95.0|-0.12|0.01||Dunnet-adjusted from ANCOVA with factors for treatment and (pooled) center and a covariate for baseline value.|ANCOVA|||||0.01|-0.12|0.15
72411280|NCT00019682|144330818|SUPERIORITY|||||||0.035|||||||Chi-squared|||||||0.035
72411281|NCT00019682|144330819|SUPERIORITY|||||||0.008||||||Unadjusted 2 tail p value.|Log Rank|||||||0.008
72411282|NCT00019682|144330820|SUPERIORITY||||||>|0.05|||||||Fisher Exact|||||||>0.05
72411283|NCT00019682|144330821|NON_INFERIORITY|Evaluated inferiority in quality of life outcomes between arms.|||||>|0.05|||||||Mixed Models Analysis|||FACT-G scale||||>0.05
72543875|NCT02868281|144617721|OTHER||Difference in Least Squares Mean|-3.3||||0.801|TWO_SIDED|95.0|-31.7|25.1|||Mixed Model Repeat Measures||Weeks 13-16. The model included covariates of treatment, center, Baseline ACT total score, type of Baseline controller, gender, age and treatment-by-visit interaction, with the center as a random factor.|||25.1|-31.7|0.801
72543876|NCT02868281|144617721|OTHER||Difference in Least Squares Mean|-5.0||||0.704|TWO_SIDED|95.0|-33.3|23.4|||Mixed Model Repeat Measures||Weeks 17-20. The model included covariates of treatment, center, Baseline ACT total score, type of Baseline controller, gender, age and treatment-by-visit interaction, with the center as a random factor.|||23.4|-33.3|0.704
72543877|NCT02868281|144617721|OTHER||Difference in Least Squares Mean|-4.0||||0.762|TWO_SIDED|95.0|-32.4|24.5|||Mixed Model Repeat Measures||Weeks 21-24. The model included covariates of treatment, center, Baseline ACT total score, type of Baseline controller, gender, age and treatment-by-visit interaction, with the center as a random factor.|||24.5|-32.4|0.762
72543878|NCT02868281|144617722|OTHER||Difference in Least Squares Mean|-12.8||||0.354|TWO_SIDED|95.0|-42.1|16.5|||Mixed Model Repeat Measures||Weeks 1-4. The model included covariates of treatment, center, Baseline ACT total score, type of Baseline controller, gender, age and treatment-by-visit interaction, with the center as a random factor.|||16.5|-42.1|0.354
72543879|NCT02868281|144617722|OTHER||Difference in Least Squares Mean|-8.4||||0.538|TWO_SIDED|95.0|-37.8|21.0|||Mixed Model Repeat Measures||Weeks 5-8. The model included covariates of treatment, center, Baseline ACT total score, type of Baseline controller, gender, age and treatment-by-visit interaction, with the center as a random factor.|||21.0|-37.8|0.538
72543880|NCT02868281|144617722|OTHER||Difference in Least Squares Mean|-5.0||||0.716|TWO_SIDED|95.0|-34.4|24.5|||Mixed Model Repeat Measures||Weeks 9-12. The model included covariates of treatment, center, Baseline ACT total score, type of Baseline controller, gender, age and treatment-by-visit interaction, with the center as a random factor.|||24.5|-34.4|0.716
72543881|NCT02868281|144617722|OTHER||Difference in Least Squares Mean|-3.1||||0.822|TWO_SIDED|95.0|-32.5|26.3|||Mixed Model Repeat Measures||Weeks 13-16. The model included covariates of treatment, center, Baseline ACT total score, type of Baseline controller, gender, age and treatment-by-visit interaction, with the center as a random factor.|||26.3|-32.5|0.822
72543882|NCT02868281|144617722|OTHER||Difference in Least Squares Mean|-4.0||||0.767|TWO_SIDED|95.0|-33.4|25.4|||Mixed Model Repeat Measures||Weeks 17-20. The model included covariates of treatment, center, Baseline ACT total score, type of Baseline controller, gender, age and treatment-by-visit interaction, with the center as a random factor.|||25.4|-33.4|0.767
72543883|NCT02868281|144617722|OTHER||Difference in Least Squares Mean|-3.8||||0.779|TWO_SIDED|95.0|-33.4|25.7|||Mixed Model Repeat Measures||Weeks 21-24. The model included covariates of treatment, center, Baseline ACT total score, type of Baseline controller, gender, age and treatment-by-visit interaction, with the center as a random factor.|||25.7|-33.4|0.779
72543884|NCT02868281|144617723|OTHER||Difference in Least Squares Mean|0.3||||0.059|TWO_SIDED|95.0|0.0|0.6|||Mixed Model Repeat Measures||The model included covariates of treatment, center, Baseline AQLQ(S) score, type of Baseline controller, gender and age, with the center as a random factor.|||0.6|-0.0|0.059
72543885|NCT02868281|144617724|OTHER||Hazard Ratio (HR)|1.843||||0.01|TWO_SIDED|95.0|1.16|2.926|||Cox proportional hazards model||The model included treatment, Baseline ACT total score, center, type of Baseline controller, gender and age as covariates.|||2.926|1.160|0.010
72543886|NCT02868281|144617725|OTHER||Rate Ratio|1.09||||0.897|TWO_SIDED|95.0|0.32|3.73|||Generalised linear model||The model included treatment, Baseline ACT total score, type of Baseline controller, gender and age as covariates.|||3.73|0.32|0.897
72543887|NCT01841359|144617745|OTHER|||||||0.9|||||||Wilcoxon (Mann-Whitney)|||||||0.90
72543888|NCT01841359|144617746|OTHER|||||||0.08|||||||t-test, 2 sided|||||||0.08
72543889|NCT01841359|144617747|OTHER||||||=|0.20492|||||||t-test, 2 sided|||||||= 0.20492
72543890|NCT01841359|144617748|OTHER|||||||0.2655|||||||t-test, 2 sided|||||||0.2655
72543891|NCT01841359|144617749|OTHER|||||||0.64|||||||Wilcoxon (Mann-Whitney)|||||||0.64
72543892|NCT01841359|144617750|OTHER|||||||0.597|||||||t-test, 2 sided|||||||0.597
72543893|NCT01841359|144617751|OTHER|||||||0.37|||||||t-test, 2 sided|||||||0.37
72543894|NCT01841359|144617752|OTHER|||||||0.14|||||||t-test, 2 sided|||||||0.14
72543895|NCT01841359|144617753|OTHER|||||||0.412|||||||t-test, 2 sided|||||||0.412
72543896|NCT01841359|144617754|OTHER|||||||0.89|||||||t-test, 2 sided|||||||0.890
72543897|NCT01841359|144617755|OTHER|||||||0.69|||||||Fisher Exact|||||||0.69
72543898|NCT02151461|144617756|OTHER|A mixed-effects model for analysis of covariance (ANCOVA) was used to analyze changes from Baseline in plasma glucose AUC(0-3hr) at Week 4 in the Day 28 Evaluable population. The model includes factors for treatment group and fasting plasma glucose stratum.||||||0.0435||||||Baseline plasma glucose AUC(0-3hr) is adjusted as a covariate.|ANCOVA|||||||0.0435
72543899|NCT02151461|144617756|OTHER|||||||0.065|||||||ANCOVA|||||||0.065
72543900|NCT02151461|144617756|OTHER|||||||0.1216|||||||ANCOVA|||||||0.1216
72411284|NCT00019682|144330821|NON_INFERIORITY|Evaluated inferiority in quality of life outcomes between arms.|||||>|0.05|||||||Mixed Models Analysis|||FACT-F scale||||>0.05
72411285|NCT00019682|144330821|NON_INFERIORITY|Evaluated inferiority in quality of life outcomes between arms.|||||>|0.05|||||||Mixed Models Analysis|||SF-36 scale||||>0.05
72578534|NCT01685840|144684528|SUPERIORITY||Mean Difference (Final Values)|-3.343||||0.221|TWO_SIDED|95.0|-8.708|2.022||Adjusted P-value|Mixed Models Analysis|||24 month||2.022|-8.708|0.221
72578535|NCT01685840|144684529|SUPERIORITY||Mean Difference (Final Values)|-0.816||||0.615|TWO_SIDED|95.0|-3.999|2.367||Adjusted P-value|Mixed Models Analysis|||3 month||2.367|-3.999|0.615
72578536|NCT01685840|144684529|SUPERIORITY||Mean Difference (Final Values)|0.252||||0.878|TWO_SIDED|95.0|-2.977|3.482||Adjusted P-value|Mixed Models Analysis|||6 month||3.482|-2.977|0.878
72578537|NCT01685840|144684529|SUPERIORITY||Mean Difference (Final Values)|-1.406||||0.441|TWO_SIDED|95.0|-4.989|2.178||Adjusted P-value|Mixed Models Analysis|||12 month||2.178|-4.989|0.441
72578538|NCT01685840|144684529|SUPERIORITY||Mean Difference (Final Values)|1.091||||0.653|TWO_SIDED|95.0|-3.673|5.856||Adjusted P-value|Mixed Models Analysis|||24 month||5.856|-3.673|0.653
72578539|NCT01685840|144684530|SUPERIORITY||Mean Difference (Final Values)|-1.226||||0.199|TWO_SIDED|95.0|-3.097|0.645||Adjusted P-value|Mixed Models Analysis|||3 month||0.645|-3.097|0.199
72578540|NCT01685840|144684530|SUPERIORITY||Mean Difference (Final Values)|-0.742||||0.465|TWO_SIDED|95.0|-2.735|1.25|||Mixed Models Analysis|||6 month||1.250|-2.735|0.465
72578541|NCT01685840|144684530|SUPERIORITY||Mean Difference (Final Values)|-0.074||||0.943|TWO_SIDED|95.0|-2.119|1.97||Adjusted P-value|Mixed Models Analysis|||12 month||1.970|-2.119|0.943
72578542|NCT01685840|144684530|SUPERIORITY||Mean Difference (Final Values)|1.478||||0.294|TWO_SIDED|95.0|-1.286|4.241||Adjusted P-value|Mixed Models Analysis|||24 month||4.241|-1.286|0.294
72578543|NCT01685840|144684531|SUPERIORITY||Mean Difference (Final Values)|-1.579||||0.294|TWO_SIDED|95.0|-4.527|1.369||Adjusted P-value|Mixed Models Analysis|||3 month||1.369|-4.527|0.294
72578544|NCT01685840|144684531|SUPERIORITY||Mean Difference (Final Values)|-0.946||||0.555|TWO_SIDED|95.0|-4.096|2.203||Adjusted P-value|Mixed Models Analysis|||6 month||2.203|-4.096|0.555
72578545|NCT01685840|144684531|SUPERIORITY||Mean Difference (Final Values)|-0.798||||0.643|TWO_SIDED|95.0|-4.178|2.583||Adjusted P-value|Mixed Models Analysis|||12 month||2.583|-4.178|0.643
72578546|NCT01685840|144684531|SUPERIORITY||Mean Difference (Final Values)|-0.647||||0.757|TWO_SIDED|95.0|-4.767|3.472||Adjusted P-value|Mixed Models Analysis|||24 month||3.472|-4.767|0.757
72411286|NCT00019682|144330821|NON_INFERIORITY|Evaluated inferiority in quality of life outcomes between arms.|||||>|0.05|||||||Mixed Models Analysis|||SDS scale||||>0.05
72578547|NCT01685840|144684532|SUPERIORITY||Mean Difference (Final Values)|-0.484||||0.837|TWO_SIDED|95.0|-5.102|4.133||Adjusted P-value|Mixed Models Analysis|||3 month||4.133|-5.102|0.837
72578548|NCT01685840|144684532|SUPERIORITY||Mean Difference (Final Values)|-2.693||||0.288|TWO_SIDED|95.0|-7.662|2.276||Adjusted P-value|Mixed Models Analysis|||6 month||2.276|-7.662|0.288
72578549|NCT01685840|144684532|SUPERIORITY||Mean Difference (Final Values)|-1.539||||0.567|TWO_SIDED|95.0|-6.81|3.732||Adjusted P-value|Mixed Models Analysis|||12 month||3.732|-6.810|0.567
72578550|NCT01685840|144684532|SUPERIORITY||Mean Difference (Final Values)|2.512||||0.475|TWO_SIDED|95.0|-4.394|9.419||Adjusted P-value|Mixed Models Analysis|||24 month||9.419|-4.394|0.475
72578551|NCT01685840|144684533|SUPERIORITY||Mean Difference (Final Values)|1.057||||0.696|TWO_SIDED|95.0|-4.25|6.364||Adjusted P-value|Mixed Models Analysis|||3 month||6.364|-4.250|0.696
72578552|NCT01685840|144684533|SUPERIORITY||Mean Difference (Final Values)|1.966||||0.497|TWO_SIDED|95.0|-3.715|7.647||Adjusted P-value|Mixed Models Analysis|||6 months||7.647|-3.715|0.497
72578553|NCT01685840|144684533|SUPERIORITY||Mean Difference (Final Values)|6.564||||0.035|TWO_SIDED|95.0|0.456|12.673||Adjusted P-value|Mixed Models Analysis|||12 month||12.673|0.456|0.035
72578554|NCT01685840|144684533|SUPERIORITY||Mean Difference (Final Values)|2.857||||0.488|TWO_SIDED|95.0|-5.247|10.961||Adjusted P-value|Mixed Models Analysis|||24 month||10.961|-5.247|0.488
72578555|NCT01685840|144684534|SUPERIORITY||Mean Difference (Final Values)|0.017||||0.992|TWO_SIDED|95.0|-3.383|3.417||Adjusted P-value|Mixed Models Analysis|||3 month||3.417|-3.383|0.992
72578556|NCT01685840|144684534|SUPERIORITY||Mean Difference (Final Values)|0.28||||0.882|TWO_SIDED|95.0|-3.409|3.969||Adjusted P-value|Mixed Models Analysis|||6 month||3.969|-3.409|0.882
72578557|NCT01685840|144684534|SUPERIORITY||Mean Difference (Final Values)|0.904||||0.647|TWO_SIDED|95.0|-2.973|4.782||Adjusted P-value|Mixed Models Analysis|||12 month||4.782|-2.973|0.647
72578558|NCT01685840|144684534|SUPERIORITY||Mean Difference (Final Values)|0.322||||0.903|TWO_SIDED|95.0|-4.894|5.538||Adjusted P-value|Mixed Models Analysis|||24 month||5.538|-4.894|0.903
72578559|NCT01685840|144684535|SUPERIORITY|||||||0.74|||||||Wilcoxon (Mann-Whitney)|||Hospitalizations||||0.74
72578560|NCT01685840|144684535|SUPERIORITY|||||||0.45|||||||Wilcoxon (Mann-Whitney)|||ER only events||||0.45
72578561|NCT01685840|144684535|SUPERIORITY|||||||0.67|||||||Wilcoxon (Mann-Whitney)|||Rehab facilities||||0.67
72578562|NCT01685840|144684535|SUPERIORITY|||||||0.47|||||||Wilcoxon (Mann-Whitney)|||Total admissions||||0.47
72578563|NCT01685840|144684536|SUPERIORITY|||||||0.88|||||||Wilcoxon (Mann-Whitney)|||Hospital Costs||||0.88
72578564|NCT01685840|144684536|SUPERIORITY|||||||0.69|||||||Wilcoxon (Mann-Whitney)|||Physician Fees||||0.69
72578565|NCT01685840|144684536|SUPERIORITY|||||||0.88|||||||Wilcoxon (Mann-Whitney)|||Total Cost||||0.88
72578566|NCT01406444|144684537|SUPERIORITY|||||||0.03|||||||Linear random effects model|||||||0.03
72578567|NCT01406444|144684538|SUPERIORITY|||||||0.002|||||||Linear random effects model|||||||0.002
72578568|NCT01406444|144684538|SUPERIORITY|||||||0.04|||||||Linear random effects model|||||||0.04
72543901|NCT02151461|144617757|OTHER|A mixed-effects model for analysis of covariance (ANCOVA) was used to analyze changes from Baseline in incremental plasma glucose AUC at Week 4 in the Day 28 Evaluable population. The model will include factors for treatment group and fasting plasma glucose stratum.||||||0.8867|||||||ANCOVA|The model includes factors for treatment group and fasting plasma glucose stratum.||||||0.8867
72411287|NCT02199691|144330827|NON_INFERIORITY|95% confidence interval (CI) of the difference was calculated from the Wilson Score Method without continuity correction. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference between the 2 percentages was \> -10%.|Percentage Difference|9.2|||||TWO_SIDED|95.0|3.4|15.0||||||Serogroup A||15|3.4|
72411288|NCT02199691|144330827|NON_INFERIORITY|95% CI of the difference was calculated from the Wilson Score Method without continuity correction. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference between the 2 percentages was \> -10%.|Percentage Difference|24.6|||||TWO_SIDED|95.0|20.3|29.0||||||Serogroup C||29|20.3|
72411289|NCT02199691|144330827|NON_INFERIORITY|95% CI of the difference was calculated from the Wilson Score Method without continuity correction. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference between the 2 percentages was \> -10%.|Percentage Difference|16.2|||||TWO_SIDED|95.0|12.3|20.2||||||||20.2|12.3|
72411290|NCT02199691|144330827|NON_INFERIORITY|95% CI of the difference was calculated from the Wilson Score Method without continuity correction. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference between the 2 percentages was \> -10%.|Percentage Difference|19.6|||||TWO_SIDED|95.0|14.2|24.8||||||Serogroup W||24.8|14.2|
72411291|NCT02199691|144330828|NON_INFERIORITY|95% CI of the difference was calculated from the Wilson Score Method without continuity correction. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference between the 2 percentages was \> -10%.|Percentage Difference|5.0|||||TWO_SIDED|95.0|-0.8|10.5||||||Serogroup A||10.5|-0.8|
72411292|NCT02199691|144330828|NON_INFERIORITY|95% CI of the difference was calculated from the Wilson Score Method without continuity correction. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference between the 2 percentages was \> -10%.|Percentage Difference|0.0|||||TWO_SIDED|95.0|-2.5|2.4||||||Serogroup C||2.4|-2.5|
72411293|NCT02199691|144330828|NON_INFERIORITY|95% CI of the difference was calculated from the Wilson Score Method without continuity correction. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference between the 2 percentages was \> -10%.|Percentage Difference|-1.4|||||TWO_SIDED|95.0|-4.3|1.2||||||Serogroup Y||1.2|-4.3|
72411294|NCT02199691|144330828|NON_INFERIORITY|95% CI of the difference was calculated from the Wilson Score Method without continuity correction. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference between the 2 percentages was \> -10%.|Percentage Difference|-2.3|||||TWO_SIDED|95.0|-7.3|2.6||||||Serogroup W||2.6|-7.3|
72543902|NCT02151461|144617757|OTHER|||||||0.7641|||||||ANCOVA|||||||0.7641
72543903|NCT02151461|144617757|OTHER|||||||0.2518|||||||ANCOVA|||||||0.2518
72543904|NCT02151461|144617758|OTHER|||||||0.0179|||||||ANCOVA|Total daily dose is twice the respective dose, Pairwise comparison using Treatment D as the reference group||||||0.0179
72543905|NCT02151461|144617758|OTHER|||||||0.0736|||||||ANCOVA|||||||0.0736
72543906|NCT02151461|144617758|OTHER|||||||0.0475|||||||ANCOVA|||||||0.0475
72543907|NCT02151461|144617759|OTHER|||||||0.0089|||||||ANCOVA|Total daily dose is twice the respective dose. Pairwise Comparison using Treatment D as the Reference Group||||||0.0089
72543908|NCT02151461|144617759|OTHER|||||||0.376|||||||ANCOVA|||||||0.376
72543909|NCT02151461|144617759|OTHER|||||||0.0578|||||||ANCOVA|||||||0.0578
72543910|NCT02151461|144617760|OTHER|||||||0.2177|||||||ANCOVA|Total daily dose is twice the respective dose. Pairwise Comparison using Treatment D as the Reference Group||The HOMA Calculator,is an algorithm that takes account of variations in hepatic and peripheral glucose resistance, increases in insulin secretion curve for plasma glucose concentrations above 10 mmol/L (180 mg/dL), and contribution of circulating proinsulin (eg, C-peptide) to estimate steady state beta cell function (%HOMA-B) and insulin sensitivity (%HOMA-S), as percentages of a normal reference population. %HOMA-IR was analyzed on a logarithmic scale (natural logarithmic transformation).||||0.2177
72543911|NCT02151461|144617760|OTHER|||||||0.4144|||||||ANCOVA|||||||0.4144
72543912|NCT02151461|144617760|OTHER|||||||0.3117|||||||ANCOVA|||||||0.3117
72543913|NCT02151461|144617761|OTHER|Average Change in Pre-meal Glucose Level||||||0.011|||||||ANCOVA|Total daily dose is twice the respective dose Pairwise comparison using Treatment D as the reference group||||||0.011
72543914|NCT02151461|144617761|OTHER|Average Change in Pre-meal Glucose Level||||||0.0152|||||||ANCOVA|||||||0.0152
72543915|NCT02151461|144617761|OTHER|Average Change in Pre-meal Glucose Level||||||0.0284|||||||ANCOVA|||||||0.0284
72543916|NCT02151461|144617761|OTHER|Average Change in Post-meal Glucose Level||||||0.1273|||||||ANCOVA|Total daily dose is twice the respective dose Pairwise comparison using Treatment D as the reference group||||||0.1273
72543917|NCT02151461|144617761|OTHER|Average Change in Post-meal Glucose Level||||||0.0085|||||||ANCOVA|||||||0.0085
72543918|NCT02151461|144617761|OTHER|Average Change in Post-meal Glucose Level||||||0.1289|||||||ANCOVA|||||||0.1289
72543919|NCT02151461|144617762|OTHER|Plasma Insulin Absolute AUC(0-2hr) (h\*uIU/mL)||||||0.3143|||||||ANCOVA|Total daily dose is twice the respective dose. Pairwise comparison using Treatment D as the reference group.||||||0.3143
72543920|NCT02151461|144617762|OTHER|Plasma Insulin Absolute AUC(0-2hr) (h\*uIU/mL)||||||0.5677|||||||ANCOVA|||||||0.5677
72543921|NCT02151461|144617762|OTHER|Plasma Insulin Absolute AUC(0-2hr) (h\*uIU/mL)||||||0.8407|||||||ANCOVA|||||||0.8407
72543922|NCT02151461|144617763|OTHER|||||||0.9789|||||||ANCOVA|Total daily dose is twice the respective dose Pairwise comparison using Treatment D as the reference group||||||0.9789
72543923|NCT02151461|144617763|OTHER|||||||0.841|||||||ANCOVA|||||||0.841
72543924|NCT02151461|144617763|OTHER|||||||0.748|||||||ANCOVA|||||||0.748
72543925|NCT01102777|144617768|SUPERIORITY_OR_OTHER|||||||0.142|TWO_SIDED||||||Regression, Linear|Adjusted for baseline value of outcome, MMRC dyspnea score, and urban versus rural residence.||||||0.142
72411295|NCT02199691|144330829|NON_INFERIORITY|95% CI of the difference was calculated from the Wilson Score Method without continuity correction. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the ratio was \>2/3.|Geometric Mean Ratio|0.845|||||TWO_SIDED|95.0|0.722|0.99||||||PT: Geometric Mean Ratio||0.99|0.722|
72543926|NCT01102777|144617769|SUPERIORITY_OR_OTHER|||||||0.502|TWO_SIDED||||||Mixed Models Analysis|Based on mixed models, adjusting for group, time, group\*time interaction, MMRC score, and urban versus rural residence.||||||.502
72543927|NCT01102777|144617770|SUPERIORITY_OR_OTHER|||||||0.9|TWO_SIDED||||||Regression, Linear|Adjusted for baseline value and rural residence.||||||.90
72543928|NCT01102777|144617771|SUPERIORITY_OR_OTHER|||||||0.93|TWO_SIDED||||||Regression, Linear|Adjusted for baseline value and rural residence.||||||.93
72543929|NCT01102777|144617772|SUPERIORITY_OR_OTHER|||||||0.08|TWO_SIDED||||||Zero inflated Poisson regression|Adjusted for age, gender, oxygen use, and arm.||||||.08
72578569|NCT04700137|144684568|SUPERIORITY||Mean Difference (Final Values)|-1.0||||0.31|TWO_SIDED|95.0|-3.0|1.0||p\<0.05 = a priori threshold for statistical significance|Regression, Linear|Linear regression with robust standard errors, adjusting for the baseline score as a precision variable.|A T-score of 50 represents the mean of the US general population (based on the 2010 Census) and 10 T-score units represents one standard deviation. Higher T-score indicates higher loneliness.|Difference in loneliness among patients by intervention arm at follow-up (6 months).||1.0|-3.0|0.31
72543930|NCT01102777|144617773|SUPERIORITY_OR_OTHER|||||||0.731|TWO_SIDED||||||Mixed Models Analysis|Based on mixed models, adjusting for group, time, group\*time interaction, MMRC score, and urban versus rural residence.||||||0.731
72543931|NCT01102777|144617774|SUPERIORITY_OR_OTHER|||||||0.52|||||||Mixed Models Analysis|Based on mixed models, adjusting for time, MMRC score, and urban versus rural residence.||||||.52
72543932|NCT01102777|144617775|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0|||||TWO_SIDED|||||||||The determination of arm occurred after recruitment, and Study Reach is a recruitment value.||||
72543933|NCT01102777|144617776|SUPERIORITY_OR_OTHER|||||||0.11|||||||Regression, Linear|Adjusting for time, MMRC score, and urban versus rural residence.||||||.11
72543934|NCT01102777|144617777|SUPERIORITY_OR_OTHER|||||||0.01|||||||Mixed Models Analysis|Based on mixed models, adjusting for time, MMRC score, and urban versus rural residence.||||||.01
72543935|NCT01965652|144617782|SUPERIORITY_OR_OTHER||LS Mean Difference|1.28|STANDARD_ERROR_OF_MEAN|0.226|<|0.0001|TWO_SIDED|95.0|0.83|1.72||The significance level was set at 0.05 (2-sided). The analysis of efficacy endpoints was not adjusted for multiplicity; hence, the p-values are purely nominal. A mixed-effects model repeated measures (MMRM) method was used for the comparisons.|Mixed-effects model repeated measures|The MMRM method included the opioid dose strata as a covariate and treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 12 Analysis||1.72|0.83|<0.0001
72543936|NCT01965652|144617782|SUPERIORITY_OR_OTHER||LS Mean Difference|1.0|STANDARD_ERROR_OF_MEAN|0.24|<|0.0001|TWO_SIDED|95.0|0.53|1.47|||Mixed-effects model repeated measures|The MMRM method included the opioid dose strata as a covariate and treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 24 Analysis||1.47|0.53|<0.0001
72543937|NCT01965652|144617782|SUPERIORITY_OR_OTHER||LS Mean Difference|1.01|STANDARD_ERROR_OF_MEAN|0.249|<|0.0001|TWO_SIDED|95.0|0.52|1.5|||Mixed-effects model repeated measures|The MMRM method included the opioid dose strata as a covariate and treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 36 Analysis||1.50|0.52|<0.0001
72543938|NCT01965652|144617782|SUPERIORITY_OR_OTHER||LS Mean Difference|1.0|STANDARD_ERROR_OF_MEAN|0.259||0.0001|TWO_SIDED|95.0|0.49|1.51|||Mixed-effects model repeated measures|The MMRM method included the opioid dose strata as a covariate and treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 52 Analysis||1.51|0.49|0.0001
72578570|NCT04700137|144684568|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.83|TWO_SIDED|95.0|-1.8|2.2||p\<0.05 = a priori threshold for statistical significance|Regression, Linear|Linear regression with robust standard errors, adjusting for the baseline score as a precision variable.|A T-score of 50 represents the mean of the US general population (based on the 2010 Census) and 10 T-score units represents one standard deviation. Higher T-score indicates higher loneliness.|Difference in loneliness among healthcare providers/staff by intervention arm at follow-up (6 months).||2.2|-1.8|0.83
72543939|NCT01965652|144617784|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.35|STANDARD_ERROR_OF_MEAN|0.05|<|0.0001|TWO_SIDED|95.0|-0.44|-0.25|||Mixed-effects model repeated measures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 2 Analysis||-0.25|-0.44|<0.0001
72543940|NCT01965652|144617784|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.25|STANDARD_ERROR_OF_MEAN|0.055|<|0.0001|TWO_SIDED|95.0|-0.36|-0.14|||Mixed-effects model repeated measures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 12 Analysis||-0.14|-0.36|<0.0001
72543941|NCT01965652|144617784|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.29|STANDARD_ERROR_OF_MEAN|0.056|<|0.0001|TWO_SIDED|95.0|-0.4|-0.18|||Mixed-effects model repeated measures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 24 Analysis||-0.18|-0.40|<0.0001
72543942|NCT01965652|144617784|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.35|STANDARD_ERROR_OF_MEAN|0.057|<|0.0001|TWO_SIDED|95.0|-0.47|-0.24|||Mixed-effects model repeated measures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 36 Analysis||-0.24|-0.47|<0.0001
72543943|NCT01965652|144617784|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.24|STANDARD_ERROR_OF_MEAN|0.059|<|0.0001|TWO_SIDED|95.0|-0.35|-0.12|||Mixed-effects model repeated measures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 52 Analysis||-0.12|-0.35|<0.0001
72543944|NCT01965652|144617785|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.054||0.0002|TWO_SIDED|95.0|-0.31|-0.1|||Mixed-effects model repeated measures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 2 Analysis||-0.10|-0.31|0.0002
72411296|NCT02199691|144330829|NON_INFERIORITY|95% CI of the difference was calculated from the Wilson Score Method without continuity correction. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the ratio was \>2/3.|Geometric Mean Ratio|0.746|||||TWO_SIDED|95.0|0.661|0.842||||||FHA: Geometric Mean Ratio||0.842|0.661|
72543945|NCT01965652|144617785|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.06||0.0173|TWO_SIDED|95.0|-0.26|-0.03|||Mixed-effects model repeated meaures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 12 Analysis||-0.03|-0.26|0.0173
72543946|NCT01965652|144617785|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.061||0.0035|TWO_SIDED|95.0|-0.3|-0.06|||Mixed-effects model repeated measures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 24 Analysis||-0.06|-0.30|0.0035
72543947|NCT01965652|144617785|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.28|STANDARD_ERROR_OF_MEAN|0.061|<|0.0001|TWO_SIDED|95.0|-0.4|-0.16|||Mixed-effects model repeated measures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 36 Analysis||-0.16|-0.40|<0.0001
72543948|NCT01965652|144617785|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.064||0.0336|TWO_SIDED|95.0|-0.26|-0.01|||Mixed-effects model repeated measures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 52 Analysis||-0.01|-0.26|0.0336
72543949|NCT01965652|144617786|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.25|STANDARD_ERROR_OF_MEAN|0.057|<|0.0001|TWO_SIDED|95.0|-0.37|-0.14|||Mixed-effects model repeated measures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 2 Analysis||-0.14|-0.37|<0.0001
72543950|NCT01965652|144617786|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.063||0.0114|TWO_SIDED|95.0|-0.28|-0.04|||Mixed-effects model repeated measures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 12 Analysis||-0.04|-0.28|0.0114
72543951|NCT01965652|144617786|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.23|STANDARD_ERROR_OF_MEAN|0.065||0.0003|TWO_SIDED|95.0|-0.36|-0.11|||Mixed-effects model repeated measures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 24 Analysis||-0.11|-0.36|0.0003
72543952|NCT01965652|144617786|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.25|STANDARD_ERROR_OF_MEAN|0.064|<|0.0001|TWO_SIDED|95.0|-0.38|-0.13|||Mixed-effects model repeated measures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 36 Analysis||-0.13|-0.38|<0.0001
72543953|NCT01965652|144617786|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.066||0.0119|TWO_SIDED|95.0|-0.29|-0.04|||Mixed-effects model repeated measures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 52 Analysis||-0.04|-0.29|0.0119
72543954|NCT01965652|144617787|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.51|STANDARD_ERROR_OF_MEAN|0.063|<|0.0001|TWO_SIDED|95.0|-0.64|-0.39|||Mixed-effects model repeated measures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 2 Analysis||-0.39|-0.64|<0.0001
72543955|NCT01965652|144617787|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.38|STANDARD_ERROR_OF_MEAN|0.066|<|0.0001|TWO_SIDED|95.0|-0.51|-0.26|||Mixed-effects model repeated measures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 12 Analysis||-0.26|-0.51|<0.0001
72543956|NCT01965652|144617787|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.067|<|0.0001|TWO_SIDED|95.0|-0.54|-0.27|||Mixed-effects model repeated measures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 24 Analysis||-0.27|-0.54|<0.0001
72543957|NCT01965652|144617787|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.48|STANDARD_ERROR_OF_MEAN|0.071|<|0.0001|TWO_SIDED|95.0|-0.62|-0.34|||Mixed-effects model repeated measures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 36 Analysis||-0.34|-0.62|<0.0001
72543958|NCT01965652|144617787|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.37|STANDARD_ERROR_OF_MEAN|0.072|<|0.0001|TWO_SIDED|95.0|-0.52|-0.23|||Mixed-effects model repeated measures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 52 Analysis||-0.23|-0.52|<0.0001
72543959|NCT01965652|144617788|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.047|<|0.0001|TWO_SIDED|95.0|-0.49|-0.3|||Mixed-effects model repeated measures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 2 Analysis||-0.30|-0.49|<0.0001
72543960|NCT01965652|144617788|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.36|STANDARD_ERROR_OF_MEAN|0.051|<|0.0001|TWO_SIDED|95.0|-0.46|-0.26|||Mixed-effects model repeated measures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 12 Analysis||-0.26|-0.46|<0.0001
72543961|NCT01965652|144617788|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.33|STANDARD_ERROR_OF_MEAN|0.054|<|0.0001|TWO_SIDED|95.0|-0.43|-0.22|||Mixed-effects model repeated measures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 24 Analysis||-0.22|-0.43|<0.0001
72543962|NCT01965652|144617788|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.055|<|0.0001|TWO_SIDED|95.0|-0.5|-0.29|||Mixed-effects model repeated measures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 36 Analysis||-0.29|-0.50|<0.0001
72411297|NCT02199691|144330829|NON_INFERIORITY|95% CI of the difference was calculated from the Wilson Score Method without continuity correction. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the ratio was \>2/3.|Geometric Mean Ratio|0.753|||||TWO_SIDED|95.0|0.627|0.903||||||PRN: Geometric Mean Ratio||0.903|0.627|
72411298|NCT02199691|144330829|NON_INFERIORITY|95% CI of the difference was calculated from the Wilson Score Method without continuity correction. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the ratio was \>2/3.|Geometric Mean Ratio|0.679|||||TWO_SIDED|95.0|0.525|0.878||||||FIM: Geometric Mean Ratio||0.878|0.525|
72411299|NCT02199691|144330830|NON_INFERIORITY|95% CI of the difference was calculated from the Wilson Score Method without continuity correction. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference between the 2 percentages was \>-10%.|Percentage Difference|-1.1|||||TWO_SIDED|95.0|-3.3|1.3||||||Serogroup Diphtheria||1.3|-3.3|
72543963|NCT01965652|144617788|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.31|STANDARD_ERROR_OF_MEAN|0.056|<|0.0001|TWO_SIDED|95.0|-0.42|-0.2|||Mixed-effects model repeated measures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 52 Analysis||-0.20|-0.42|<0.0001
72543964|NCT01965652|144617789|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.39|STANDARD_ERROR_OF_MEAN|0.056|<|0.0001|TWO_SIDED|95.0|-0.5|-0.28|||Mixed-effects model repeated measures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 2 Analysis||-0.28|-0.50|<0.0001
72543965|NCT01965652|144617789|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.32|STANDARD_ERROR_OF_MEAN|0.063|<|0.0001|TWO_SIDED|95.0|-0.44|-0.2|||Mixed-effects model repeated measures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 12 Anaysis||-0.20|-0.44|<0.0001
72543966|NCT01965652|144617789|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.27|STANDARD_ERROR_OF_MEAN|0.065|<|0.0001|TWO_SIDED|95.0|-0.4|-0.15|||Mixed-effects model repeated measures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 24 Analysis||-0.15|-0.40|<0.0001
72543967|NCT01965652|144617789|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.34|STANDARD_ERROR_OF_MEAN|0.068|<|0.0001|TWO_SIDED|95.0|-0.48|-0.21|||Mixed-effects model repeated measures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 36 Analysis||-0.21|-0.48|<0.0001
72543968|NCT01965652|144617789|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.28|STANDARD_ERROR_OF_MEAN|0.067|<|0.0001|TWO_SIDED|95.0|-0.41|-0.15|||Mixed-effects model repeated measures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 52 Analysis||-0.15|-0.41|<0.0001
72543969|NCT01965652|144617790|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.24|STANDARD_ERROR_OF_MEAN|0.051|<|0.0001|TWO_SIDED|95.0|-0.34|-0.14|||Mixed-effects model repeated measures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 2 Analysis||-0.14|-0.34|<0.0001
72543970|NCT01965652|144617790|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.24|STANDARD_ERROR_OF_MEAN|0.055|<|0.0001|TWO_SIDED|95.0|-0.35|-0.14|||Mixed-effects model repeated measures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 12 Analysis||-0.14|-0.35|<0.0001
72543971|NCT01965652|144617790|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.25|STANDARD_ERROR_OF_MEAN|0.057|<|0.0001|TWO_SIDED|95.0|-0.36|-0.14|||Mixed-effects model repeated measures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 24 Analysis||-0.14|-0.36|<0.0001
72543972|NCT01965652|144617790|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.31|STANDARD_ERROR_OF_MEAN|0.059|<|0.0001|TWO_SIDED|95.0|-0.43|-0.19|||Mixed-effects model repeated measures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 36 Analysis||-0.19|-0.43|<0.0001
72578571|NCT04700137|144684569|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.05|TWO_SIDED|95.0|0.0|0.5||p\<0.05 = a priori threshold for statistical significance|Regression, Linear|Linear regression with robust standard errors, adjusting for the baseline score as a precision variable.||Difference in suicidal ideation and behavior (C-SSRS) among patients by intervention arm at follow-up (6 months).||0.5|0.0|0.05
72578572|NCT04700137|144684569|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.2|TWO_SIDED|95.0|-0.4|0.1||p\<0.05 = a priori threshold for statistical significance|Regression, Linear|Linear regression with robust standard errors, adjusting for the baseline score as a precision variable.||Difference in suicidal ideation and behavior (C-SSRS) among healthcare providers/staff by intervention arm at follow-up (6 months).||0.1|-0.4|0.2
72578573|NCT04700137|144684570|SUPERIORITY||Mean Difference (Final Values)|-0.4||||0.45|TWO_SIDED|95.0|-1.5|0.7||p\<0.05 = a priori threshold for statistical significance|Regression, Linear|Linear regression with robust standard errors, adjusting for the baseline score as a precision variable.||Difference in depression (PHQ-9) among patients by intervention arm at follow-up (6 months).||0.7|-1.5|0.45
72578574|NCT04700137|144684570|SUPERIORITY||Median Difference (Final Values)|0.3||||0.51|TWO_SIDED|95.0|-0.7|1.3||p\<0.05 = a priori threshold for statistical significance|Regression, Linear|Linear regression with robust standard errors, adjusting for the baseline score as a precision variable.||Difference in depression (PHQ-9) among healthcare providers/staff by intervention arm at follow-up (6 months).||1.3|-0.7|0.51
72578575|NCT04700137|144684571|SUPERIORITY||Mean Difference (Final Values)|-0.3||||0.54|TWO_SIDED|95.0|-1.3|0.7||p\<0.05 = a priori threshold for statistical significance|Regression, Linear|Linear regression with robust standard errors, adjusting for the baseline score as a precision variable.||Difference in anxiety (GAD-7) among patients by intervention arm at follow-up (6 months).||0.7|-1.3|0.54
72578576|NCT04700137|144684571|SUPERIORITY||Mean Difference (Final Values)|1.0||||0.04|TWO_SIDED|95.0|0.1|2.0||p\<0.05 = a priori threshold for statistical significance|Regression, Linear|Linear regression with robust standard errors, adjusting for the baseline score as a precision variable.||Difference in anxiety (GAD-7) among healthcare providers/staff by intervention arm at follow-up (6 months).||2.0|0.1|0.04
72543973|NCT01965652|144617790|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.21|STANDARD_ERROR_OF_MEAN|0.061||0.0006|TWO_SIDED|95.0|-0.33|-0.09|||Mixed-effects model repeated measures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 52 Analysis||-0.09|-0.33|0.0006
72543974|NCT01965652|144617791|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.39|STANDARD_ERROR_OF_MEAN|0.054|<|0.0001|TWO_SIDED|95.0|-0.5|-0.29|||Mixed-effects model repeated measures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 2 Analysis||-0.29|-0.50|<0.0001
72543975|NCT01965652|144617791|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.36|STANDARD_ERROR_OF_MEAN|0.06|<|0.0001|TWO_SIDED|95.0|-0.48|-0.24|||Mixed-effects model repeated measures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 12 Analysis||-0.24|-0.48|<0.0001
72543976|NCT01965652|144617791|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.33|STANDARD_ERROR_OF_MEAN|0.061|<|0.0001|TWO_SIDED|95.0|-0.45|-0.21|||Mixed-effects model repeated measures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 24 Analysis||-0.21|-0.45|<0.0001
72543977|NCT01965652|144617791|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.42|STANDARD_ERROR_OF_MEAN|0.062|<|0.0001|TWO_SIDED|95.0|-0.54|-0.3|||Mixed-effects model repeated measures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 36 Analysis||-0.30|-0.54|<0.0001
72543978|NCT01965652|144617791|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.32|STANDARD_ERROR_OF_MEAN|0.064|<|0.0001|TWO_SIDED|95.0|-0.44|-0.19|||Mixed-effects model repeated measures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 52 Analysis||-0.19|-0.44|<0.0001
72543979|NCT01965652|144617792|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.67|STANDARD_ERROR_OF_MEAN|0.07|<|0.0001|TWO_SIDED|95.0|-0.81|-0.53|||Mixed-effects model repeated measures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 2 Analysis||-0.53|-0.81|<0.0001
72543980|NCT01965652|144617792|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.58|STANDARD_ERROR_OF_MEAN|0.075|<|0.0001|TWO_SIDED|95.0|-0.73|-0.43|||Mixed-effects model repeated measures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 12 Analysis||-0.43|-0.73|<0.0001
72543981|NCT01965652|144617792|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.51|STANDARD_ERROR_OF_MEAN|0.077|<|0.0001|TWO_SIDED|95.0|-0.66|-0.36|||Mixed-effects model repeated measures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 24 Analysis||-0.36|-0.66|<0.0001
72543982|NCT01965652|144617792|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.54|STANDARD_ERROR_OF_MEAN|0.08|<|0.0001|TWO_SIDED|95.0|-0.69|-0.38|||Mixed-effects model repeated measures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 36 Analysis||-0.38|-0.69|<0.0001
72543983|NCT01965652|144617792|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.48|STANDARD_ERROR_OF_MEAN|0.083|<|0.0001|TWO_SIDED|95.0|-0.64|-0.32|||Mixed-effects model repeated measures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 52 Analysis||-0.32|-0.64|<0.0001
72543984|NCT01965652|144617793|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.0001
72543985|NCT01121900|144617794|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence is established when the ratio of geometric Least Squares means (LSmeans) and confidence interval calculated from the exponential of the difference between the Test and Reference product for the ln-transformed parameter Cmax is between 80% and 125%.|Mean ratio|39.8|||||TWO_SIDED|90.0|34.4|46.0|||||Test/reference (%)|||46.0|34.4|
72543986|NCT01121900|144617795|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence is established when the ratio of geometric Least Squares means (LSmeans) and confidence interval calculated from the exponential of the difference between the Test and Reference product for the ln-transformed parameter AUC(0-tlast) is between 80% and 125%.|Mean ratio|80.9|||||TWO_SIDED|90.0|74.2|88.3|||||Test/reference (%)|||88.3|74.2|
72543987|NCT01121900|144617796|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence is established when the ratio of geometric Least Squares means (LSmeans) and confidence interval calculated from the exponential of the difference between the Test and Reference product for the ln-transformed parameter AUC(0-∞) is between 80% and 125%.|Mean ratio|83.5|||||TWO_SIDED|90.0|76.5|91.1|||||Test/reference (%)|||91.1|76.5|
72543988|NCT00566709|144617811|SUPERIORITY_OR_OTHER|||||||0.03|TWO_SIDED||||||t-test, 2 sided|||||||0.03
72543989|NCT00566709|144617812|SUPERIORITY_OR_OTHER|||||||0.07|TWO_SIDED||||||Chi-squared, Corrected|||||||0.07
72543990|NCT00566709|144617813|SUPERIORITY_OR_OTHER|||||||0.56|TWO_SIDED||||||Chi-squared, Corrected|||||||0.56
72329484|NCT03037476|144184393|OTHER|General Linear Model|Slope|-0.0061||||0.914|TWO_SIDED|95.0|-0.1161|0.104|||Mixed Models Analysis|Poisson regression||Change in cumulative grade point average at 6 month follow up||0.104|-0.1161|0.914
72411300|NCT02199691|144330830|NON_INFERIORITY|95% CI of the difference was calculated from the Wilson Score Method without continuity correction. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference between the 2 percentages was \>-10%.|Percentage Difference|0.1|||||TWO_SIDED|95.0|-1.2|1.9||||||Serogroup Tetanus||1.9|-1.2|
72543991|NCT00566709|144617814|SUPERIORITY_OR_OTHER|||||||0.79|TWO_SIDED||||||t-test, 2 sided|||||||0.79
72411301|NCT02199691|144330831|NON_INFERIORITY|95% CI of the difference was calculated from the Wilson Score Method without continuity correction. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference between the 2 percentages was \>-10%.|Percentage Difference|1.8|||||TWO_SIDED|95.0|-1.8|6.3||||||HPV Type 6||6.3|-1.8|
72543992|NCT00566709|144617815|SUPERIORITY_OR_OTHER|||||||0.77|TWO_SIDED||||||Chi-squared, Corrected|||||||0.77
72543993|NCT00566709|144617816|SUPERIORITY_OR_OTHER|||||||0.22|TWO_SIDED||||||Chi-squared, Corrected|||||||0.22
72543994|NCT03443869|144617820|NON_INFERIORITY|LET was concluded non-inferior to VGCV if the upper bound of the two-sided 95% CI for difference in percentage of participants with adjudicated CMV disease (LET - VGCV) was no higher than 10%|Stratum-adjusted Treatment Difference|-1.4|||||TWO_SIDED|95.0|-6.5|3.8|||||Difference = LET minus VGCV|The Observed failure (OF) approach was used to handle missing values, that is participants who had discontinued prematurely from the study for any reason were not considered failures||3.8|-6.5|
72543995|NCT03443869|144617821|OTHER||Stratum-adjusted Treatment Difference|-1.7|||||TWO_SIDED|95.0|-3.4|0.1|||||Difference = LET minus VGCV|The Observed failure (OF) approach was used to handle missing values, that is participants who had discontinued prematurely from the study for any reason were not considered failures||0.1|-3.4|
72543996|NCT03443869|144617823|OTHER||Difference in Percentages|-0.1|||||TWO_SIDED|95.0|-4.4|4.2|||||Difference = LET minus VGCV|||4.2|-4.4|
72543997|NCT03443869|144617824|OTHER||Difference in Percentages|-3.7|||||TWO_SIDED|95.0|-7.0|-0.9|||||Difference = LET minus VGCV|||-0.9|-7.0|
72543998|NCT02884206|144617879|NON_INFERIORITY|To demonstrate non-inferiority that LCZ696 does not lead to a relevant decrease in cognition compared to valsartan at year 3, the lower bound of 95% CI does not include the pre-specified non-inferiority (NI) boundary (Cohen's D) of -0.3. An effect size of 0.3 in Cohen's D is generally considered as small.|LSM|-0.018||||0.7363|TWO_SIDED|95.0|-0.123|0.087|||ANCOVA|||Repeated measure ANCOVA|Cohen's D: -0.0277, 95% CI: -0.1101 to 0.0778|0.0870|-0.1230|0.7363
72578577|NCT04700137|144684572|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.84|TWO_SIDED|95.0|-2.1|1.7||p\<0.05 = a priori threshold for statistical significance|Regression, Linear|Linear regression with robust standard errors.|T-score of 50 = mean of the US general population (2010 Census); 10 T-score units = one standard deviation. Higher T-scores = higher stress. T-scores equal to or greater than 60.5 (adults) or 60.8 (adolescents) are moderate or high risk.|Change in stress from baseline to 6 months among patients.||1.7|-2.1|0.84
72543999|NCT02884206|144617880|NON_INFERIORITY|To show that the point estimate of SUVr difference in mean change over 3 years is in favor of LCZ696 and the non-inferiority is demonstrated, with the upper bound of the 95% CI excluding the NI boundary of 0.01.|Least Squares Mean|-0.0292||||0.0579|TWO_SIDED|95.0|-0.0593|0.001|||ANCOVA|||Multiple Imputation ANCOVA in Global cortical composite||0.0010|-0.0593|0.0579
72544000|NCT02884206|144617881|SUPERIORITY||Least Squares Mean|0.0007||||0.9916|TWO_SIDED|95.0|-0.1339|0.1353|||ANCOVA|||Repeated measure ANCOVA for memory domain|Cohen's D: 0.0009; 95% CI: -0.0912 to 0.0922|0.1353|-0.1339|0.9916
72544001|NCT02884206|144617881|SUPERIORITY||Least Squares Mean|0.0327||||0.6348|TWO_SIDED|95.0|-0.1024|0.1677|||ANCOVA|||Repeated measure ANCOVA for executive function domain|Cohen's D: 0.0391, 95% CI: -0.0727 to 0.1192|0.1677|-0.1024|0.6348
72544002|NCT02884206|144617881|SUPERIORITY||Least Squares Mean|-0.1042||||0.2403|TWO_SIDED|95.0|-0.2783|0.07|||ANCOVA|||Repeated measure ANCOVA for attention domain|Cohen's D: -0.0967, 95% CI: -0.1542 to 0.0387|0.0700|-0.2783|0.2403
72544003|NCT02884206|144617882|SUPERIORITY||Least Squares Mean|-0.1105||||0.7081|TWO_SIDED|95.0|-0.6906|0.4696|||ANCOVA|||Repeated measure ANCOVA|Cohen's D: -0.0308, 95% CI: -0.1208 to 0.0820|0.4696|-0.6906|0.7081
72544004|NCT05117099|144617912|SUPERIORITY|||||||0.548|||||||ANOVA|||||||.548
72544005|NCT05117099|144617914|SUPERIORITY|||||||0.915|||||||ANOVA|||||||.915
72544006|NCT05117099|144617915|SUPERIORITY|||||||0.663|||||||ANOVA|||||||.663
72544007|NCT05117099|144617916|SUPERIORITY|||||||0.138|||||||ANOVA|||||||.138
72544008|NCT05117099|144617917|SUPERIORITY|||||||0.114|||||||ANOVA|||||||.114
72544009|NCT05117099|144617918|SUPERIORITY|||||||0.065|||||||ANOVA|||||||.065
72544010|NCT05117099|144617919|SUPERIORITY|||||||0.394|||||||ANOVA|||||||.394
72544011|NCT05117099|144617920|SUPERIORITY|||||||0.388|||||||ANOVA|||||||.388
72544012|NCT05117099|144617921|SUPERIORITY|||||||0.332|||||||ANOVA|||||||.332
72544013|NCT03654898|144617986|SUPERIORITY||cross-tabulation|0.48||||0.49|TWO_SIDED||||||Chi-squared|||||||0.49
72544014|NCT03654898|144617986|SUPERIORITY||Odds Ratio (OR)|1.06||||0.67|TWO_SIDED|95.0|0.8|1.42|||Regression, Logistic|Adjusted logistic regression||||1.42|0.80|0.67
72544015|NCT03654898|144617987|SUPERIORITY||Cross-tabulation|0.71||||0.4|TWO_SIDED||||||Chi-squared|||||||0.40
72544016|NCT03654898|144617988|SUPERIORITY||Cross-tabulation|0.5||||0.78|TWO_SIDED||||||Chi-squared|||Test 1 was for TFVdp while test 2 was for 3TCtp.||||0.78
72544017|NCT03654898|144617988|SUPERIORITY||Cross-tabulation|2.13||||0.34|TWO_SIDED||||||Chi-squared|||Test 2 was for 3TCtp while test 1 was for TFVdp.||||0.34
72544018|NCT01271933|144617989|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0186|TWO_SIDED|||||The p-value was calculated using log-rank test for comparing pregabalin CR with placebo|Log Rank|||||||0.0186
72544019|NCT01271933|144617993|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.41||0.331|TWO_SIDED|95.0|-1.2|0.4||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model|ANCOVA|||||0.4|-1.2|0.3310
72544020|NCT01271933|144617996|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.4||0.9247|TWO_SIDED|95.0|-0.8|0.8||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||||0.8|-0.8|0.9247
72578578|NCT04700137|144684572|SUPERIORITY||Mean Difference (Final Values)|1.5||||0.18|TWO_SIDED|95.0|-0.7|3.7||p\<0.05 = a priori threshold for statistical significance|Regression, Linear|Linear regression with robust standard errors.|T-score of 50 = mean of the US general population (2010 Census); 10 T-score units = one standard deviation. Higher T-scores = higher stress. T-scores equal to or greater than 60.5 (adults) or 60.8 (adolescents) are moderate or high risk.|Change in stress from baseline to 6 months among healthcare providers/staff.||3.7|-0.7|0.18
72578579|NCT04700137|144684573|SUPERIORITY||Mean Difference (Final Values)|0.5||||0.38|TWO_SIDED|95.0|-0.6|1.6||p\<0.05 = a priori threshold for statistical significance|Regression, Linear|Linear regression with robust standard errors, adjusting for the baseline score as a precision variable.||Difference in perceived burdensomeness (INQ15) among patients by intervention arm at follow-up (6 months).||1.6|-0.6|0.38
72578580|NCT04700137|144684573|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.81|TWO_SIDED|95.0|-0.8|1.0||p\<0.05 = a priori threshold for statistical significance|Regression, Linear|Linear regression with robust standard errors, adjusting for the baseline score as a precision variable.||Difference in perceived burdensomeness (INQ15) among healthcare providers/staff by intervention arm at follow-up (6 months).||1.0|-0.8|0.81
72578581|NCT04700137|144684573|SUPERIORITY||Mean Difference (Final Values)|-0.4||||0.73|TWO_SIDED|95.0|-2.6|1.8||p\<0.05 = a priori threshold for statistical significance|Regression, Linear|Linear regression with robust standard errors, adjusting for the baseline score as a precision variable.||Difference in thwarted belongingness (INQ15) among patients by intervention arm at follow-up (6 months).||1.8|-2.6|0.73
72578582|NCT04700137|144684573|SUPERIORITY||Mean Difference (Final Values)|1.2||||0.24|TWO_SIDED|95.0|-0.8|3.2||p\<0.05 = a priori threshold for statistical significance|Regression, Linear|Linear regression with robust standard errors, adjusting for the baseline score as a precision variable.||Difference in thwarted belongingness (INQ15) among healthcare providers/staff by intervention arm at follow-up (6 months).||3.2|-0.8|0.24
72544021|NCT01271933|144618005|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.6|STANDARD_ERROR_OF_MEAN|7.12||0.4314|TWO_SIDED|95.0|-19.7|8.5||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model|ANCOVA|||This analysis is for the domain: Subjective Wake after Sleep Onset||8.5|-19.7|0.4314
72544022|NCT01271933|144618005|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.3|STANDARD_ERROR_OF_MEAN|9.26||0.8915|TWO_SIDED|95.0|-17.1|19.6||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||This analysis is for the domain: Subjective Latency to Sleep Onset||19.6|-17.1|0.8915
72544023|NCT01271933|144618006|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.3|STANDARD_ERROR_OF_MEAN|0.41||0.4571|TWO_SIDED|95.0|-0.5|1.1||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||||1.1|-0.5|0.4571
72544024|NCT01271933|144618007|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|0.2||0.3779|TWO_SIDED|95.0|-0.2|0.6||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||||0.6|-0.2|0.3779
72544025|NCT01271933|144618008|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.4|STANDARD_ERROR_OF_MEAN|0.34||0.2009|TWO_SIDED|95.0|-0.2|1.1||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||||1.1|-0.2|0.2009
72544026|NCT01271933|144618010|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.48||0.1845|TWO_SIDED|95.0|-1.6|0.3||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||||0.3|-1.6|0.1845
72544027|NCT01271933|144618013|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-9.9|STANDARD_ERROR_OF_MEAN|4.52||0.0305|TWO_SIDED|95.0|-18.9|1.0||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||This analysis is for the domain: Sleep disturbance||1.0|-18.9|0.0305
72544028|NCT01271933|144618013|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.2|STANDARD_ERROR_OF_MEAN|5.17||0.3133|TWO_SIDED|95.0|-5.0|15.5||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||This analysis is for the domain: Snoring||15.5|-5.0|0.3133
72544029|NCT01271933|144618013|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.9|STANDARD_ERROR_OF_MEAN|3.71||0.2985|TWO_SIDED|95.0|-11.2|3.5||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||This analysis is for the domain: Awakening Short of Breath or with a Headache||3.5|-11.2|0.2985
72544030|NCT01271933|144618013|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|6.8|STANDARD_ERROR_OF_MEAN|5.49||0.2159|TWO_SIDED|95.0|-4.1|17.7||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||This analysis is for the domain: Sleep adequacy||17.7|-4.1|0.2159
72578583|NCT04700137|144684575|SUPERIORITY||Risk Difference (RD)|-5.6||||0.12|TWO_SIDED|95.0|-12.5|1.4||p\<0.05 = a priori threshold for statistical significance|GLM|Generalized linear model (GLM) with an identity link and binomial variance||Number of participants with increased tobacco use among patients randomized to CC+ vs CC||1.4|-12.5|0.12
72578584|NCT04700137|144684575|SUPERIORITY||Risk Difference (RD)|-6.1||||0.03|TWO_SIDED|95.0|-11.5|-0.7||p\<0.05 = a priori threshold for statistical significance|GLM|Generalized linear model (GLM) with an identity link and binomial variance||Number of participants with increased tobacco use among healthcare providers/staff randomized to CC+ vs CC||-0.7|-11.5|0.03
72411302|NCT02199691|144330831|NON_INFERIORITY|95% CI of the difference was calculated from the Wilson Score Method without continuity correction. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference between the 2 percentages was \>-10%.|Percentage Difference|0.8|||||TWO_SIDED|95.0|-1.3|3.9||||||HPV Type 11||3.9|-1.3|
72411303|NCT02199691|144330831|NON_INFERIORITY|95% CI of the difference was calculated from the Wilson Score Method without continuity correction. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference between the 2 percentages was \>-10%.|Percentage Difference|0.4|||||TWO_SIDED|95.0|-1.9|3.6||||||HPV Type 16||3.6|-1.9|
72411304|NCT02199691|144330831|NON_INFERIORITY|95% CI of the difference was calculated from the Wilson Score Method without continuity correction. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference between the 2 percentages was \>-10%.|Percentage Difference|0.4|||||TWO_SIDED|95.0|-1.9|3.6||||||HPV Type 18||3.6|-1.9|
72411305|NCT01782131|144330927|NON_INFERIORITY|Based on Miettinen and Nurminen's method stratified by the risk for mortality/poor outcome (high risk, not high risk) and using Cochran-Mantel-Haenszel weighting scheme. The p-Value is based on the one-sided non-inferiority test. Non-inferiority of posaconazole vs. voriconazole is established if the upper limit of the 95% confidence interval is less than 10%.|Estimated Difference in Percent|-5.3|||<|0.0001|TWO_SIDED|95.0|-11.6|1.0|||Miettinen and Nurminen|||||1.0|-11.6|<.0001
72411306|NCT01782131|144330928|OTHER|Based on Miettinen and Nurminen's method stratified by the risk for mortality/poor outcome (high risk, not high risk) and using Cochran-Mantel-Haenszel weighting scheme.|Estimated Difference in Percent|0.3|||||TWO_SIDED|95.0|-8.2|8.8||||||||8.8|-8.2|
72411307|NCT01782131|144330929|OTHER|Based on Miettinen and Nurminen's method stratified by the risk for mortality/poor outcome (high risk, not high risk) and using Cochran-Mantel-Haenszel weighting scheme.|Estimated Difference in Percent|-2.5|||||TWO_SIDED|95.0|-9.9|4.9||||||||4.9|-9.9|
72411308|NCT01782131|144330930|OTHER|Based on Miettinen and Nurminen's method stratified by the risk for mortality/poor outcome (high risk, not high risk) and using Cochran-Mantel-Haenszel weighting scheme.|Estimated Difference in Percent|3.1|||||TWO_SIDED|95.0|-6.9|13.1||||||||13.1|-6.9|
72544031|NCT01271933|144618013|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.2|STANDARD_ERROR_OF_MEAN|4.1||0.2041|TWO_SIDED|95.0|-13.4|2.9||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||This analysis is for the domain: Somnolence||2.9|-13.4|0.2041
72578585|NCT04700137|144684575|SUPERIORITY||Risk Difference (RD)|-1.1||||0.83|TWO_SIDED|95.0|-10.7|8.5||p\<0.05 = a priori threshold for statistical significance|GLM|Generalized linear model (GLM) with an identity link and binomial variance||Number of participants with increased alcohol use among patients randomized to CC+ vs CC||8.5|-10.7|0.83
72578586|NCT04700137|144684575|SUPERIORITY||Risk Difference (RD)|2.2||||0.67|TWO_SIDED|95.0|-8.0|12.5||p\<0.05 = a priori threshold for statistical significance|GLM|Generalized linear model (GLM) with an identity link and binomial variance||Number of participants with increased alcohol use among healthcare providers/staff randomized to CC+ vs CC||12.5|-8.0|0.67
72411309|NCT01782131|144330931|OTHER|Based on Miettinen and Nurminen's method stratified by the risk for mortality/poor outcome (high risk, not high risk) and using Cochran-Mantel-Haenszel weighting scheme.|Estimated Difference in Percent|-3.4|||||TWO_SIDED|95.0|-13.9|7.1||||||||7.1|-13.9|
72411310|NCT01782131|144330932|OTHER|Based on Miettinen and Nurminen's method stratified by the risk for mortality/poor outcome (high risk, not high risk) and using Cochran-Mantel-Haenszel weighting scheme.|Difference in Percent|-0.6|||||TWO_SIDED|95.0|-11.2|10.1||||||||10.1|-11.2|
72411311|NCT01782131|144330933|OTHER||Survival Rate in Percent|60.7||||0.2767|TWO_SIDED|95.0|52.8|67.8||Based on Stratified Log-Rank method stratified by the risk for mortality/poor outcome (high risk, not high risk).|Kaplan-Meier|From product-limit (Kaplan-Meier) method for censored data.||Analysis of Time to All-Cause Mortality Through Day 114: Posaconazole vs. Voriconazole||67.8|52.8|0.2767
72411312|NCT01782131|144330934|OTHER|Based on Miettinen and Nurminen's method.|Difference in Percent|20.4|||||TWO_SIDED|95.0|-4.1|42.7||||||||42.7|-4.1|
72411313|NCT01782131|144330935|OTHER|Based on Miettinen and Nurminen's method.|Difference in Percent|11.3|||||TWO_SIDED|95.0|-6.9|28.6||||||||28.6|-6.9|
72411314|NCT01782131|144330936|OTHER||Difference in Percent|0.3||||0.8305|TWO_SIDED|95.0|-2.9|3.6|||Miettinen & Nurminen|||Abnormal Hepatic Laboratory Value||3.6|-2.9|0.8305
72411315|NCT01782131|144330936|OTHER||Difference in Percent|-3.6||||0.3633|TWO_SIDED|95.0|-11.3|4.2|||Miettinen & Nurminen|||CNS and Visual Disturbances||4.2|-11.3|0.3633
72411316|NCT01782131|144330936|OTHER||Difference in Percent|-2.8||||0.3724|TWO_SIDED|95.0|-9.1|3.4|||Miettinen & Nurminen|||Dermatologic Reactions||3.4|-9.1|0.3724
72411317|NCT01782131|144330936|OTHER||Difference in Percent|1.0||||0.6431|TWO_SIDED|95.0|-3.4|5.5|||Miettinen & Nurminen|||Adrenal Insufficiency or Temporal Hypotension||5.5|-3.4|0.6431
72411318|NCT01782131|144330937|OTHER|Based on Miettinen \& Nurminen|Difference in Percent|0.0|||||TWO_SIDED|95.0|-2.8|2.8||||||||2.8|-2.8|
72411319|NCT01782131|144330938|OTHER|Based on Miettinen \& Nurminen method.|Difference in Percent|-10.2|||||TWO_SIDED|95.0|-17.9|-2.4||||||||-2.4|-17.9|
72411320|NCT01782131|144330939|OTHER|Based on Miettinen \& Nurminen method.|Difference in Percent|1.9|||||TWO_SIDED|95.0|-6.1|9.8||||||||9.8|-6.1|
72411321|NCT01782131|144330940|OTHER|Based on Miettinen \& Nurminen method.|Difference in Percent|-1.4|||||TWO_SIDED|95.0|-5.6|2.7||||||||2.7|-5.6|
72544032|NCT01271933|144618013|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.8|STANDARD_ERROR_OF_MEAN|3.81||0.1319|TWO_SIDED|95.0|-13.4|1.8||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||This analysis is for the domain: Sleep Problems Index I||1.8|-13.4|0.1319
72578587|NCT04700137|144684575|SUPERIORITY||Risk Difference (RD)|2.9||||0.42|TWO_SIDED|95.0|-4.1|9.9||p\<0.05 = a priori threshold for statistical significance|GLM|Generalized linear model (GLM) with an identity link and binomial variance||Number of participants with increased marijuana/cannabis use among patients randomized to CC+ vs CC||9.9|-4.1|0.42
72411322|NCT01782131|144330941|OTHER|Based on Miettinen \& Nurminen method.|Difference in Percent|-3.2|||||TWO_SIDED|95.0|-11.0|4.5||||||||4.5|-11.0|
72544033|NCT01271933|144618013|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.7|STANDARD_ERROR_OF_MEAN|3.89||0.1473|TWO_SIDED|95.0|-13.4|2.0||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||This analysis is for the domain: Sleep Problems Index II||2.0|-13.4|0.1473
72544034|NCT01271933|144618014|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|0.2||0.3596|TWO_SIDED|95.0|-0.2|0.6||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||||0.6|-0.2|0.3596
72544035|NCT01271933|144618016|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.25||||0.4985|TWO_SIDED|95.0|0.66|2.36||Nominal p-value for two-sided test.|two-sided test|||"Odds ratio is the probability of the event occurring in Pregabalin 330 - 495 mg/day relative to the event occurring in Placebo for Pregabalin.~Odds ratio \> 1 is in favor of Pregabalin 330 - 495 mg/day."||2.36|0.66|0.4985
72578588|NCT04700137|144684575|SUPERIORITY||Risk Difference (RD)|-2.1||||0.53|TWO_SIDED|95.0|-8.7|4.5||p\<0.05 = a priori threshold for statistical significance|GLM|Generalized linear model (GLM) with an identity link and binomial variance||Number of participants with increased marijuana/cannabis use among healthcare providers/staff randomized to CC+ vs CC||4.5|-8.7|0.53
72578589|NCT04700137|144684575|SUPERIORITY||Risk Difference (RD)|-2.5||||0.2|TWO_SIDED|95.0|-6.3|1.4||p\<0.05 = a priori threshold for statistical significance|GLM|Generalized linear model (GLM) with an identity link and binomial variance||Number of participants with increased illicit drug use among patients randomized to CC+ vs CC||1.4|-6.3|0.20
72578590|NCT04700137|144684575|SUPERIORITY||Risk Difference (RD)|-0.7||||0.62|TWO_SIDED|95.0|-3.4|2.0||p\<0.05 = a priori threshold for statistical significance|GLM|Generalized linear model (GLM) with an identity link and binomial variance||Number of participants with increased illicit drug use among healthcare providers/staff randomized to CC+ vs CC||2.0|-3.4|0.62
72578591|NCT04700137|144684576|SUPERIORITY||Risk Difference (RD)|-4.5||||0.41|TWO_SIDED|95.0|-15.4|6.3||p\<0.05 = a priori threshold for statistical significance|GLM|Generalized linear model (GLM) with an identity link and binomial variance||Difference in proportion of patients attending mental healthcare appointments by intervention arm at follow-up (6 months).||6.3|-15.4|0.41
72578592|NCT04700137|144684576|SUPERIORITY||Risk Difference (RD)|5.5||||0.31|TWO_SIDED|95.0|-5.2|16.2||p\<0.05 = a priori threshold for statistical significance|GLM|Generalized linear model (GLM) with an identity link and binomial variance||Difference in proportion of healthcare providers/staff attending mental healthcare appointments by intervention arm at follow-up (6 months).||16.2|-5.2|0.31
72578593|NCT04386616|144684605|SUPERIORITY||Hazard Ratio (HR)|1.01||||0.9266|TWO_SIDED|95.0|0.75|1.36||p\<0.05 threshold for statistical significance|Unstratified Log Rank||The hazard ratio was calculated as the MSTT1041A Arm relative to the Placebo Arm.|||1.36|0.75|0.9266
72578594|NCT04386616|144684605|SUPERIORITY||Hazard Ratio (HR)|1.15||||0.357|TWO_SIDED|95.0|0.86|1.54||p\<0.05 threshold for statistical significance|Unstratified Log Rank||The hazard ratio was calculated as the UTTR1147A Arm relative to the Placebo Arm.|||1.54|0.86|0.3570
72578595|NCT04386616|144684605|SUPERIORITY||Hazard Ratio (HR)|1.0||||0.9812|TWO_SIDED|95.0|0.74|1.36||p\<0.05 threshold for statistical significance|Stratified Log Rank|The analysis was adjusted for the baseline characteristics of region of enrollment and need for mechanical ventilation.|The hazard ratio was calculated as the MSTT1041A Arm relative to the Placebo Arm.|||1.36|0.74|0.9812
72544036|NCT01271933|144618018|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.4|STANDARD_ERROR_OF_MEAN|4.1||0.74|TWO_SIDED|95.0|-9.5|6.8||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||This analysis is for the domain: SF-36 Physical Functioning||6.8|-9.5|0.7400
72544037|NCT01271933|144618018|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.6|STANDARD_ERROR_OF_MEAN|4.89||0.5938|TWO_SIDED|95.0|-7.1|12.3||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||This analysis is for the domain: SF-36 Role-Physical||12.3|-7.1|0.5938
72544038|NCT01271933|144618018|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.2|STANDARD_ERROR_OF_MEAN|4.61||0.4842|TWO_SIDED|95.0|-5.9|12.4||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||This analysis is for the domain: SF-36 Pain Index||12.4|-5.9|0.4842
72544039|NCT01271933|144618018|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.1|STANDARD_ERROR_OF_MEAN|3.45||0.0827|TWO_SIDED|95.0|-12.9|0.8||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model|ANCOVA|||This analysis is for the domain: SF-36 General Health Perceptions||0.8|-12.9|0.0827
72578596|NCT04386616|144684605|SUPERIORITY||Hazard Ratio (HR)|1.1||||0.5151|TWO_SIDED|95.0|0.82|1.49||p\<0.05 threshold for statistical significance|Stratified Log Rank|The analysis was adjusted for the baseline characteristics of region of enrollment and need for mechanical ventilation.|The hazard ratio was calculated as the UTTR1147A Arm relative to the Placebo Arm.|||1.49|0.82|0.5151
72578597|NCT04386616|144684606|SUPERIORITY||Hazard Ratio (HR)|1.03||||0.8373|TWO_SIDED|95.0|0.77|1.39|||Unstratified Log Rank||The hazard ratio was calculated as the MSTT1041A Arm relative to the Placebo Arm.|||1.39|0.77|0.8373
72578598|NCT04386616|144684606|SUPERIORITY||Hazard Ratio (HR)|1.15||||0.3396|TWO_SIDED|95.0|0.86|1.55|||Unstratified Log Rank||The hazard ratio was calculated as the UTTR1147A Arm relative to the Placebo Arm.|||1.55|0.86|0.3396
72578599|NCT04386616|144684606|SUPERIORITY||Hazard Ratio (HR)|1.03||||0.8619|TWO_SIDED|95.0|0.76|1.39|||Stratified Log Rank|The analysis was adjusted for the baseline characteristics of region of enrollment and need for mechanical ventilation.|The hazard ratio was calculated as the MSTT1041A Arm relative to the Placebo Arm.|||1.39|0.76|0.8619
72578600|NCT04386616|144684606|SUPERIORITY||Hazard Ratio (HR)|1.11||||0.4913|TWO_SIDED|95.0|0.82|1.5|||Stratified Log Rank|The analysis was adjusted for the baseline characteristics of region of enrollment and need for mechanical ventilation.|The hazard ratio was calculated as the UTTR1147A Arm relative to the Placebo Arm.|||1.50|0.82|0.4913
72578601|NCT04386616|144684607|SUPERIORITY||Hazard Ratio (HR)|1.11||||0.4711|TWO_SIDED|95.0|0.83|1.49|||Unstratified Log Rank||The hazard ratio was calculated as the MSTT1041A Arm relative to the Placebo Arm.|||1.49|0.83|0.4711
72544040|NCT01271933|144618018|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.5|STANDARD_ERROR_OF_MEAN|4.73||0.4561|TWO_SIDED|95.0|-12.09|5.8||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||This analysis is for the domain: SF-36 Vitality||5.8|-12.09|0.4561
72544041|NCT01271933|144618018|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|4.31||0.9645|TWO_SIDED|95.0|-8.8|8.4||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||This analysis is for the domain: SF-36 Social Functioning||8.4|-8.8|0.9645
72544042|NCT01271933|144618018|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.6|STANDARD_ERROR_OF_MEAN|5.41||0.7636|TWO_SIDED|95.0|-9.1|12.4||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||This analysis is for the domain: SF-36 Role-Emotional||12.4|-9.1|0.7636
72544043|NCT01271933|144618018|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.3|STANDARD_ERROR_OF_MEAN|3.54||0.7067|TWO_SIDED|95.0|-5.7|8.4||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||This analysis is for the domain: SF-36 Mental Health Index||8.4|-5.7|0.7067
72544044|NCT01271933|144618018|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|1.78||0.8352|TWO_SIDED|95.0|-3.9|3.2||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||This analysis is for the domain: Physical Component Score||3.2|-3.9|0.8352
72544045|NCT01271933|144618018|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|2.22||0.9347|TWO_SIDED|95.0|-4.2|4.6||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||This analysis is for the domain: Mental Component Score||4.6|-4.2|0.9347
72544046|NCT01271933|144618020|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.9|STANDARD_ERROR_OF_MEAN|0.69||0.1901|TWO_SIDED|95.0|-0.5|2.3||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||HADS-A Anxiety scale||2.3|-0.5|0.1901
72544047|NCT01271933|144618020|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.65||0.6914|TWO_SIDED|95.0|-1.6|1.0||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||HADS-D Depression scale||1.0|-1.6|0.6914
72578602|NCT04386616|144684607|SUPERIORITY||Hazard Ratio (HR)|1.16||||0.3135|TWO_SIDED|95.0|0.87|1.56|||Unstratified Log Rank||The hazard ratio was calculated as the UTTR1147A Arm relative to the Placebo Arm.|||1.56|0.87|0.3135
72578603|NCT04386616|144684607|SUPERIORITY||Hazard Ratio (HR)|1.09||||0.5735|TWO_SIDED|95.0|0.81|1.48|||Stratified Log Rank|The analysis was adjusted for the baseline characteristics of region of enrollment and need for mechanical ventilation.|The hazard ratio was calculated as the MSTT1041A Arm relative to the Placebo Arm.|||1.48|0.81|0.5735
72578604|NCT04386616|144684607|SUPERIORITY||Hazard Ratio (HR)|1.08||||0.5973|TWO_SIDED|95.0|0.8|1.46|||Stratified Log Rank|The analysis was adjusted for the baseline characteristics of region of enrollment and need for mechanical ventilation.|The hazard ratio was calculated as the UTTR1147A Arm relative to the Placebo Arm.|||1.46|0.80|0.5973
72578605|NCT04386616|144684608|SUPERIORITY||Median Difference (Net)|-1.0||||0.5304|||||||Van Elteren||The median difference was calculated as the MSTT1041A Arm minus the Placebo Arm.|||||0.5304
72578606|NCT04386616|144684608|SUPERIORITY||Median Difference (Net)|-4.5||||0.5058|||||||Van Elteren||The median difference was calculated as the UTT1147A Arm minus the Placebo Arm.|||||0.5058
72578607|NCT04386616|144684609|SUPERIORITY||Odds Ratio (OR)|1.05||||0.8451|TWO_SIDED|95.0|0.64|1.72|||Chi-squared||The odds ratio was calculated as the MSTT1041A Arm relative to the Placebo Arm.|||1.72|0.64|0.8451
72578608|NCT04386616|144684609|SUPERIORITY||Odds Ratio (OR)|1.09||||0.7267|TWO_SIDED|95.0|0.67|1.79|||Chi-squared||The odds ratio was calculated as the UTTR1147A Arm relative to the Placebo Arm.|||1.79|0.67|0.7267
72578609|NCT04386616|144684609|SUPERIORITY||Odds Ratio (OR)|1.06||||0.8458|TWO_SIDED|95.0|0.63|1.79|||Cochran-Mantel-Haenszel|The analysis was adjusted for the baseline characteristics of region of enrollment and need for mechanical ventilation.|The odds ratio was calculated as the MSTT1041A Arm relative to the Placebo Arm.|||1.79|0.63|0.8458
72578610|NCT04386616|144684609|SUPERIORITY||Odds Ratio (OR)|1.08||||0.7907|TWO_SIDED|95.0|0.64|1.81|||Cochran-Mantel-Haenszel|The analysis was adjusted for the baseline characteristics of region of enrollment and need for mechanical ventilation.|The odds ratio was calculated as the UTTR1147A Arm relative to the Placebo Arm.|||1.81|0.64|0.7907
72578611|NCT04386616|144684610|SUPERIORITY||Median Difference (Final Values)|0.0||||0.5273|||||||Van Elteren||The median difference was calculated as the MSTT1041A Arm minus the Placebo Arm.|||||0.5273
72578612|NCT04386616|144684610|SUPERIORITY||Median Difference (Final Values)|0.0||||0.6515|||||||Van Elteren||The median difference was calculated as the UTT1147A Arm minus the Placebo Arm.|||||0.6515
72578613|NCT04386616|144684610|SUPERIORITY||Odds Ratio (OR)|1.16||||0.5475|TWO_SIDED|95.0|0.71|1.91|||Proportional Odds Model|The analysis was adjusted for the baseline characteristics of region of enrollment and need for mechanical ventilation.|The odds ratio was calculated as the MSTT1041A Arm relative to the Placebo Arm.|||1.91|0.71|0.5475
72578614|NCT04386616|144684610|SUPERIORITY||Odds Ratio (OR)|1.16||||0.5652|TWO_SIDED|95.0|0.71|1.89|||Proportional Odds Model|The analysis was adjusted for the baseline characteristics of region of enrollment and need for mechanical ventilation.|The odds ratio was calculated as the UTTR1147A Arm relative to the Placebo Arm.|||1.89|0.71|0.5652
72544048|NCT01271933|144618022|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.4|STANDARD_ERROR_OF_MEAN|0.41||0.3721|TWO_SIDED|95.0|-0.5|1.2||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||This analysis is for the domain: Item 1: Physical activities||1.2|-0.5|0.3721
72544049|NCT01271933|144618022|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|0.64||0.8084|TWO_SIDED|95.0|-1.1|1.4||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||This analysis is for the domain: Item 2: Feel good||1.4|-1.1|0.8084
72544050|NCT01271933|144618022|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.35||0.6312|TWO_SIDED|95.0|-0.9|0.5||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||This analysis is for the domain: Item 3: Work missed||0.5|-0.9|0.6312
72544051|NCT01271933|144618022|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.57||0.8824|TWO_SIDED|95.0|-1.0|1.2||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||This analysis is for the domain: Item 4: Do job||1.2|-1.0|0.8824
72578615|NCT04386616|144684611|SUPERIORITY||Median Difference (Final Values)|0.0||||0.3401|||||||Van Elteren||The median difference was calculated as the MSTT1041A Arm minus the Placebo Arm.|||||0.3401
72578616|NCT04386616|144684611|SUPERIORITY||Median Difference (Final Values)|0.0||||0.4676|||||||Van Elteren||The median difference was calculated as the UTT1147A Arm minus the Placebo Arm.|||||0.4676
72411323|NCT00587587|144330963|SUPERIORITY_OR_OTHER|||||||1||||||"P-value compares overall incidence of AEs between groups, ie Apligraf 12/17 and Control 10/13.~UADE is defined in 21CFR812.3(s)"|Fisher Exact|||Fisher's exact test used to evaluate treatment differences between Apligraf subjects and Control subjects experiencing any AEs.||||1.0000
72411324|NCT00587587|144330964|SUPERIORITY_OR_OTHER|||||||0.5863||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.5863
72544052|NCT01271933|144618022|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|0.49||0.2742|TWO_SIDED|95.0|-1.5|0.4||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||This analysis is for the domain: Item 5: Pain||0.4|-1.5|0.2742
72544053|NCT01271933|144618022|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.46||0.852|TWO_SIDED|95.0|-0.8|1.0||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||This analysis is for the domain: Item 6: Fatigue||1.0|-0.8|0.8520
72544054|NCT01271933|144618022|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.55||0.5264|TWO_SIDED|95.0|-1.4|0.7||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||This analysis is for the domain: Item 7: Rested||0.7|-1.4|0.5264
72544055|NCT01271933|144618022|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.55||0.6601|TWO_SIDED|95.0|-1.3|0.9||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||This analysis is for the domain: Item 8: Stiffness||0.9|-1.3|0.6601
72544056|NCT01271933|144618022|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.56||0.8937|TWO_SIDED|95.0|-1.2|1.0||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||This analysis is for the domain: Item 9: Anxiety||1.0|-1.2|0.8937
72544057|NCT01271933|144618022|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.47||0.9151|TWO_SIDED|95.0|-1.0|0.9||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||This analysis is for the domain: Item 10: Depression||0.9|-1.0|0.9151
72578617|NCT04386616|144684611|SUPERIORITY||Odds Ratio (OR)|1.31||||0.3408|TWO_SIDED|95.0|0.75|2.29|||Proportional Odds Model|The analysis was adjusted for the baseline characteristics of region of enrollment and need for mechanical ventilation.|The odds ratio was calculated as the MSTT1041A Arm relative to the Placebo Arm.|||2.29|0.75|0.3408
72578618|NCT04386616|144684611|SUPERIORITY||Odds Ratio (OR)|1.32||||0.332|TWO_SIDED|95.0|0.76|2.29|||Proportional Odds Model|The analysis was adjusted for the baseline characteristics of region of enrollment and need for mechanical ventilation.|The odds ratio was calculated as the UTTR1147A Arm relative to the Placebo Arm.|||2.29|0.76|0.3320
72578619|NCT04386616|144684612|SUPERIORITY||Difference in percentage of participants|3.83|||||TWO_SIDED|95.0|-7.57|15.24|||||The difference in percentage of participants was calculated as the MSTT1041A Arm minus the Placebo Arm.|||15.24|-7.57|
72578620|NCT04386616|144684612|SUPERIORITY||Difference in percentage of participants|-0.38|||||TWO_SIDED|95.0|-11.46|10.7|||||The difference in percentage of participants was calculated as the UTTR1147A Arm minus the Placebo Arm.|||10.70|-11.46|
72411325|NCT00587587|144330965|SUPERIORITY_OR_OTHER|||||||0.3783||95.0|||||Fisher Exact|||||||0.3783
72411326|NCT00587587|144330966|SUPERIORITY_OR_OTHER|||||||0.7149|||||||Wilcoxon (Mann-Whitney)|||Treatment differences in scar firmness evaluated using a 2-tailed Wilcoxon rank sum test with pooled variances.||||0.7149
72411327|NCT00587587|144330967|SUPERIORITY_OR_OTHER|||||||0.167||95.0|||||Wilcoxon (Mann-Whitney)|||Treatment differences in scar thickness evaluated using a 2-tailed Wilcoxon rank sum test||||0.1670
72411328|NCT00587587|144330968|SUPERIORITY_OR_OTHER|||||||0.7221|TWO_SIDED|0.0|||||Wilcoxon (Mann-Whitney)|||Global assessments analyzed as ordinal ranks. Treatment differences in global assessment evaluated using a 2-tailed Wilcoxon rank sum test with pooled variances.||||0.7221
72544058|NCT01271933|144618022|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|3.91||0.9045|TWO_SIDED|95.0|-8.2|7.3||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||This analysis is for the total score||7.3|-8.2|0.9045
72544059|NCT01271933|144618024|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|0.31||0.4606|TWO_SIDED|95.0|-0.4|0.9||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||This analysis is for the domain: General Fatigue||0.9|-0.4|0.4606
72544060|NCT01271933|144618024|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.37||0.4703|TWO_SIDED|95.0|-1.0|0.5||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||This analysis is for the domain: Physical Fatigue||0.5|-1.0|0.4703
72544061|NCT01271933|144618024|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.3|STANDARD_ERROR_OF_MEAN|0.36||0.4009|TWO_SIDED|95.0|-0.4|1.0||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||This analysis is for the domain: Reduced activity||1.0|-0.4|0.4009
72544062|NCT01271933|144618024|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.6|STANDARD_ERROR_OF_MEAN|0.35||0.0695|TWO_SIDED|95.0|-0.1|1.3||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||This analysis is for the domain: Reduced motivation||1.3|-0.1|0.0695
72544063|NCT01271933|144618024|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.27||0.5869|TWO_SIDED|95.0|-0.7|0.4||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||This analysis is for the domain: Mental fatigue||0.4|-0.7|0.5869
72544064|NCT01271933|144618026|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.29||||0.0296|TWO_SIDED|95.0|1.09|4.81||Nominal p-value for two-sided test.|two-sided test|||This analysis is for the domain: Benefit from treatment||4.81|1.09|0.0296
72544065|NCT01271933|144618026|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.29||||0.4691|TWO_SIDED|95.0|0.64|2.61||Nominal p-value for two-sided test|two-sided test|||This analysis is for the domain: Satisfaction from treatment||2.61|0.64|0.4691
72578621|NCT04386616|144684612|SUPERIORITY||Odds Ratio (OR)|1.22||||0.4804|TWO_SIDED|95.0|0.7|2.1|||Chi-squared||The odds ratio was calculated as the MSTT1041A Arm relative to the Placebo Arm.|||2.10|0.70|0.4804
72544066|NCT01271933|144618026|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.98||||0.9577|TWO_SIDED|95.0|0.48|2.01||Nominal p-value for two-sided test|two-sided test|||This analysis is for the domain: Willingness to continue treatment||2.01|0.48|0.9577
72544067|NCT01271933|144618028|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|19.3|STANDARD_ERROR_OF_MEAN|9.85||0.0562|TWO_SIDED|95.0|-0.5|39.2||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||This analysis is for the domain: Percent Work Time Missed||39.2|-0.5|0.0562
72544068|NCT01271933|144618028|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.1|STANDARD_ERROR_OF_MEAN|3.96||0.7892|TWO_SIDED|95.0|-7.0|9.2||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||This analysis is for the domain: Percent Impairment While Working||9.2|-7.0|0.7892
72544069|NCT01271933|144618028|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.2|STANDARD_ERROR_OF_MEAN|1.82||0.0819|TWO_SIDED|95.0|-0.4|6.8||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||This analysis is for the domain: Percent Activity Impairment||6.8|-0.4|0.0819
72544070|NCT01271933|144618028|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.6|STANDARD_ERROR_OF_MEAN|1.91||0.4135|TWO_SIDED|95.0|-2.2|5.4||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||This analysis is for the domain: Percent Overall Work Impairment||5.4|-2.2|0.4135
72544071|NCT01271933|144618039|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.4|STANDARD_ERROR_OF_MEAN|0.24||0.1224|TWO_SIDED|95.0|-0.1|0.9||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||||0.9|-0.1|0.1224
72544072|NCT01271933|144618040|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.2|STANDARD_ERROR_OF_MEAN|4.06||0.768|TWO_SIDED|95.0|-9.3|6.9||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||||6.9|-9.3|0.7680
72544073|NCT01271933|144618041|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.9|STANDARD_ERROR_OF_MEAN|1.29||0.136|TWO_SIDED|95.0|-4.5|0.6||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||||0.6|-4.5|0.1360
72544074|NCT01271933|144618042|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|6489.5|STANDARD_ERROR_OF_MEAN|12579.5||0.6077|TWO_SIDED|95.0|-18648.6|31627.6||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||This analysis is for the domain: Total daytime activity||31627.6|-18648.6|0.6077
72544075|NCT01271933|144618043|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.6|STANDARD_ERROR_OF_MEAN|1.38||0.6647|TWO_SIDED|95.0|-2.2|3.4||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||||3.4|-2.2|0.6647
72544076|NCT00591253|144618125|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.0||||0.001|TWO_SIDED|95.0|-7.97|-2.04||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented. Overall 0.05 level of significance for multiple comparisons controlled using closed testing procedure.|ANCOVA|||||-2.04|-7.97|0.001
72544077|NCT00591253|144618125|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.78|||<|0.001|TWO_SIDED|95.0|-10.69|-4.86||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented. Overall 0.05 level of significance for multiple comparisons controlled using closed testing procedure.|ANCOVA|||||-4.86|-10.69|<0.001
72544078|NCT00591253|144618126|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.48|||<|0.001|TWO_SIDED|95.0|-10.18|-2.78||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented. Overall 0.05 level of significance for multiple comparisons controlled using closed testing procedure.|ANCOVA|||||-2.78|-10.18|<0.001
72544079|NCT00591253|144618126|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.54|||<|0.001|TWO_SIDED|95.0|-10.27|-2.81||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented. Overall 0.05 level of significance for multiple comparisons controlled using closed testing procedure.|ANCOVA|||||-2.81|-10.27|<0.001
72544080|NCT00591253|144618127|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.44||||0.001|TWO_SIDED|95.0|-5.47|-1.4||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-1.40|-5.47|0.001
72544081|NCT00591253|144618127|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.77|||<|0.001|TWO_SIDED|95.0|-7.78|-3.77||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-3.77|-7.78|<0.001
72544082|NCT00591253|144618128|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.12||||0.004|TWO_SIDED|95.0|-5.22|-1.02||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-1.02|-5.22|0.004
72544083|NCT00591253|144618128|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.96||||0.006|TWO_SIDED|95.0|-5.08|-0.84||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-0.84|-5.08|0.006
72544084|NCT00591253|144618129|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.09||||0.001|TWO_SIDED|95.0|-8.14|-2.04||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-2.04|-8.14|0.001
72544085|NCT00591253|144618129|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.97|||<|0.001|TWO_SIDED|95.0|-10.96|-4.97||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-4.97|-10.96|<0.001
72544086|NCT00591253|144618130|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.74|||<|0.001|TWO_SIDED|95.0|-5.86|-1.61||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-1.61|-5.86|<0.001
72544087|NCT00591253|144618130|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.9|||<|0.001|TWO_SIDED|95.0|-7.99|-3.81||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-3.81|-7.99|<0.001
72411329|NCT00587587|144330969|SUPERIORITY_OR_OTHER|||||||0.408|||||||Wilcoxon (Mann-Whitney)|||Global assessments analyzed as ordinal ranks. Treatment differences in global assessment evaluated using a 2-tailed Wilcoxon rank sum test with pooled variances.||||0.4080
72544088|NCT00591253|144618131|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.91||||0.008|TWO_SIDED|95.0|-8.54|-1.27||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-1.27|-8.54|0.008
72544089|NCT00591253|144618131|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.27|||<|0.001|TWO_SIDED|95.0|-10.85|-3.69||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-3.69|-10.85|<0.001
72544090|NCT00591253|144618132|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.05||||0.024|TWO_SIDED|95.0|-5.69|-0.4||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-0.40|-5.69|0.024
72544091|NCT00591253|144618132|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.79|||<|0.001|TWO_SIDED|95.0|-8.39|-3.19||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-3.19|-8.39|<0.001
72544092|NCT00591253|144618133|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.3||||0.001|TWO_SIDED|95.0|-8.52|-2.08||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-2.08|-8.52|0.001
72544093|NCT00591253|144618133|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.71|||<|0.001|TWO_SIDED|95.0|-10.88|-4.55||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-4.55|-10.88|<0.001
72544094|NCT00591253|144618134|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.81||||0.001|TWO_SIDED|95.0|-6.08|-1.54||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-1.54|-6.08|0.001
72544095|NCT00591253|144618134|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.65|||<|0.001|TWO_SIDED|95.0|-7.88|-3.41||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-3.41|-7.88|<0.001
72544096|NCT00591253|144618135|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.86||||0.014|TWO_SIDED|95.0|-8.72|-1.01||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-1.01|-8.72|0.014
72544097|NCT00591253|144618135|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.71|||<|0.001|TWO_SIDED|95.0|-12.5|-4.92||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-4.92|-12.50|<0.001
72544098|NCT00591253|144618136|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.04||||0.012|TWO_SIDED|95.0|-7.17|-0.91||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-0.91|-7.17|0.012
72544099|NCT00591253|144618136|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.55|||<|0.001|TWO_SIDED|95.0|-10.63|-4.48||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-4.48|-10.63|<0.001
72544100|NCT00591253|144618137|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.15||||0.004|TWO_SIDED|95.0|1.27|3.65||P-value for response criteria for systolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value is presented.|Regression, Logistic|||||3.65|1.27|0.004
72411330|NCT00587587|144330970|SUPERIORITY_OR_OTHER|||||||0.9556||0.0|||||Wilcoxon (Mann-Whitney)|||Differences evaluated using a 2-tailed Wilcoxon rank sum test with pooled variances.||||0.9556
72544101|NCT00591253|144618137|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.93||||0.016|TWO_SIDED|95.0|1.13|3.31||P-value for response criteria for systolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value is presented.|Regression, Logistic|||||3.31|1.13|0.016
72544102|NCT00591253|144618138|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.85||||0.018|TWO_SIDED|95.0|1.11|3.08||P-value for response criteria for diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic diastolic blood pressure as a covariate. The unadjusted p-value is presented.|Regression, Logistic|||||3.08|1.11|0.018
72544103|NCT00591253|144618138|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.89||||0.015|TWO_SIDED|95.0|1.13|3.16||P-value for response criteria for diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic diastolic blood pressure as a covariate. The unadjusted p-value is presented.|Regression, Logistic|||||3.16|1.13|0.015
72544104|NCT00591253|144618139|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.35||||0.004|TWO_SIDED|95.0|1.31|4.24||P-value for joint response criteria for systolic blood pressure and diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value is presented.|Regression, Logistic|||||4.24|1.31|0.004
72544105|NCT00591253|144618139|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.84|||<|0.001|TWO_SIDED|95.0|1.57|5.13||P-value for joint response criteria for systolic blood pressure and diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value is presented.|Regression, Logistic|||||5.13|1.57|<0.001
72544106|NCT01504867|144618155|SUPERIORITY_OR_OTHER|||||||0.53|||||||Wald|This was a large sample (Wald) test estimated using a conditional logistic regression model with site as a stratification variable.||The primary outcome significance level was adjusted for multiple testing associated with the interim analysis. Its significance level is 92.6%||||0.53
72544107|NCT01504867|144618156|SUPERIORITY_OR_OTHER||||||>|0.99|||||||Chi-squared|||||||>0.99
72544108|NCT01504867|144618157|SUPERIORITY_OR_OTHER|||||||0.36|||||||Chi-squared|||||||0.36
72544109|NCT01504867|144618158|SUPERIORITY_OR_OTHER|||||||0.23|||||||Chi-squared|||||||0.23
72544110|NCT01504867|144618159|SUPERIORITY_OR_OTHER|||||||0.72|||||||Wilcoxon (Mann-Whitney)|||||||0.72
72411331|NCT01722331|144330981|SUPERIORITY||Difference in percentages|56.6|||<|0.001|TWO_SIDED|95.0|49.6|62.8|||Cochran-Mantel-Haenszel|Stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.||||62.8|49.6|<0.001
72411332|NCT01722331|144330981|SUPERIORITY||Difference in percentages|58.0|||<|0.001|TWO_SIDED|95.0|51.0|64.1|||Cochran-Mantel-Haenszel|Stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.||||64.1|51.0|<0.001
72544111|NCT01504867|144618160|SUPERIORITY_OR_OTHER|||||||0.08|||||||Chi-squared|||||||0.08
72544112|NCT01504867|144618161|SUPERIORITY_OR_OTHER|||||||0.79|||||||Wilcoxon (Mann-Whitney)|||||||0.79
72544113|NCT01365845|144618164|SUPERIORITY_OR_OTHER||Non-parametric paired t-test (Wilcoxon)|29.1||||0.0078|||||||Wilcoxon (Mann-Whitney)|||||||0.0078
72544114|NCT03210259|144618169|EQUIVALENCE|Equivalence was concluded if the confidence interval (CI) for the least squares (LS) means ratio was included in the pre-defined equivalence range of 80.00% to 125.00%.|Least squares means ratio|105.19|||||TWO_SIDED|90.2|96.58|114.64|||||The least squares means were from ANCOVA. Ratio was calculated with the switching arm in the numerator and the continuous arm in the denominator.|The null hypothesis was that the ratio of expected means for Switching vs. Continuous Humira is less than 80.00% or more than 125.00%.||114.64|96.58|
72544115|NCT03210259|144618170|EQUIVALENCE|Equivalence was concluded if the confidence interval (CI) for the LS means ratio was included in the pre-defined equivalence range of 80.00% to 125.00%.|Least squares means ratio|101.14|||||TWO_SIDED|90.2|93.26|109.7|||||The least squares means were from ANCOVA. Ratio was calculated with the switching arm in the numerator and the continuous arm in the denominator.|The null hypothesis was that the ratio of expected means for Switching vs. Continuous Humira is less than 80.00% or more than 125.00%.||109.70|93.26|
72544116|NCT03210259|144618171|OTHER||Least squares means ratio|107.31|||||TWO_SIDED|90.2|97.33|118.43|||||The least squares means were from ANCOVA. Ratio was calculated with the switching arm as numerator and the continuous arm as the denominator.|No hypothesis was defined and no statistical test was performed.||118.43|97.33|
72544117|NCT03210259|144618173|OTHER||Risk Difference (RD)|5.75|||||TWO_SIDED|90.0|-2.45|13.96|||||Risk difference was calculated as Switching arm minus Continuous Humira.|No hypothesis was tested.||13.96|-2.45|
72544118|NCT03210259|144618174|OTHER||Risk Difference (RD)|5.63|||||TWO_SIDED|90.0|-4.35|15.62|||||Risk difference was calculated as Switching arm minus Continuous Humira.|No hypothesis was tested.||15.62|-4.35|
72544119|NCT02110706|144618180|OTHER|"A futility (non-superiority) design is a screening tool to identify whether agents should be candidates for phase III trials while minimizing costs/sample size If futility is declared, results would imply not cost effective to conduct a future phase III clinical trial If futility is not declared, suggests that there could be a clinically meaningful effect - supports exploration in a larger, phase III trial"|Odds Ratio (OR)|1.14||||0.03|ONE_SIDED|90.0||2.41|||Regression, Logistic|||"This futility design tests the following hypothesis:~H0: Rituximab improves outcome by at least 30% compared to placebo (pR - pP ≥ 0.30 - not futile) versus HA: Rituximab does not improve outcome by at least 30% compared to placebo (pR - pP \< 0.30 - futile)"||2.41||0.03
72544120|NCT02110706|144618181|SUPERIORITY||Odds Ratio (OR)|0.72||||0.63|TWO_SIDED|90.0|0.23|2.21|||t-test, 2 sided|||% of study participants with treatment related AEs||2.21|0.23|0.63
72544121|NCT02110706|144618181|SUPERIORITY||Odds Ratio (OR)|0.75||||0.65|TWO_SIDED|90.0|0.27|2.11|||t-test, 2 sided|||% study participants with treatment related SAEs||2.11|0.27|0.65
72544122|NCT02110706|144618182|OTHER||Mean Difference (Final Values)|-0.11||||0.93|ONE_SIDED|90.0||2.02|||Regression, Linear|||This objective was assessed longitudinally by comparing the final score at the end of the study to the score obtained at baseline. The outcome was defined as the change from baseline to week 52 in the MGC. This hypothesis was assessed using a linear regression model, adjusted for differences in baseline MGC scores.||2.02||0.93
72544123|NCT02110706|144618183|OTHER||Mean Difference (Final Values)|-1.09||||0.39|ONE_SIDED|90.0||1.03|||Regression, Linear|||This objective was assessed longitudinally by comparing the final score at the end of the study to the score obtained at baseline. The outcome was defined as the change from baseline to week 52 in the QMG. This hypothesis was assessed using a linear regression model, adjusted for differences in baseline QMG scores.||1.03||0.39
72544124|NCT00252187|144618189|SUPERIORITY_OR_OTHER|||||||0.004||95.0|||||Chi-squared|||Change in end systolic LV volume index compared between two groups||||0.004
72544125|NCT00252187|144618189|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||Chi-squared|||Change in LV end diastolic volume was compared between two groups||||0.001
72578622|NCT04386616|144684612|SUPERIORITY||Odds Ratio (OR)|0.98||||0.9418|TWO_SIDED|95.0|0.56|1.71|||Chi-squared||The odds ratio was calculated as the UTTR1147A Arm relative to the Placebo Arm.|||1.71|0.56|0.9418
72578623|NCT04386616|144684612|SUPERIORITY||Odds Ratio (OR)|1.29||||0.4988|TWO_SIDED|95.0|0.68|2.44|||Cochran-Mantel-Haenszel|The analysis was adjusted for the baseline characteristics of region of enrollment and need for mechanical ventilation.|The odds ratio was calculated as the MSTT1041A Arm relative to the Placebo Arm.|||2.44|0.68|0.4988
72578624|NCT04386616|144684612|SUPERIORITY||Odds Ratio (OR)|1.02||||0.9043|TWO_SIDED|95.0|0.54|1.96|||Cochran-Mantel-Haenszel|The analysis was adjusted for the baseline characteristics of region of enrollment and need for mechanical ventilation.|The odds ratio was calculated as the UTTR1147A Arm relative to the Placebo Arm.|||1.96|0.54|0.9043
72578625|NCT04386616|144684613|SUPERIORITY||Median Difference (Net)|0.0||||0.8007|||||||Van Elteren||Median difference was calculated as the MSTT1041A Arm minus the Placebo Arm.|||||0.8007
72578626|NCT04386616|144684613|SUPERIORITY||Median Difference (Net)|0.0||||0.8633|||||||Van Elteren||Median difference was calculated as the UTTR1147A Arm minus the Placebo Arm.|||||0.8633
72578627|NCT04386616|144684614|SUPERIORITY||Difference in percentage of participants|-3.59|||||TWO_SIDED|95.0|-16.31|9.12|||||The difference in percentage of participants was calculated as the MSTT1041A Arm minus the Placebo Arm.|||9.12|-16.31|
72544126|NCT00252187|144618190|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||Chi-squared|||||||0.001
72544127|NCT00252187|144618192|SUPERIORITY_OR_OTHER|||||||0.14||95.0|||||Chi-squared|||||||0.14
72544128|NCT00252187|144618193|SUPERIORITY_OR_OTHER|||||||0.006||95.0|||||Chi-squared|||||||0.006
72544129|NCT03764059|144618197|NON_INFERIORITY|The test for non-inferiority is based on a 95% CI of the difference between the investigational and control groups with respect to the rate of clinically acceptable restorations at 1-year post placement. The non-inferiority margin was 7%. To establish non-inferiority the lower limit has to be \> -7%|Risk Difference (RD)|4.2|||<|0.0001|TWO_SIDED|95.0||9.2|||Cochran-Mantel-Haenszel|||||9.2|- 0.6|< 0.0001
72544130|NCT01154153|144618238|SUPERIORITY_OR_OTHER||Treatment Ratio of Geometric mean|0.966|||||TWO_SIDED|95.0|0.892|1.045|||ANCOVA||The treatment ratio was calculated as an exponential of the mean difference between treatments in log scale.|Missing cortisol values were imputed with multiple imputation. AUC(0-24 hr) was calculated for each imputation and analyzed with log-transformation using an ANCOVA model and analyzed with treatment, sex, and age group as fixed effects, and log-transformed baseline value as a covariate. The mean difference in log scale between treatments and its standard error were calculated by Least Squares mean. Results from multiply imputed data were combined using SAS procedure MIANALYZE.||1.045|0.892|
72544131|NCT01154153|144618239|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.85|STANDARD_ERROR_OF_MEAN|0.24||0.0007|TWO_SIDED|95.0|-1.34|-0.37|||ANCOVA|For ANCOVA, treatment arm, randomization strata were fixed effects and baseline value was a covariate.||||-0.37|-1.34|0.0007
72544132|NCT01154153|144618240|SUPERIORITY_OR_OTHER|||||||0.1332||95.0||||Based on the ordinal evaluation score and adjusted for the randomization strata.|Cochran-Mantel-Haenszel|||||||0.1332
72544133|NCT01154153|144618241|SUPERIORITY_OR_OTHER|||||||0.3314||95.0||||Based on the ordinal evaluation score and adjusted for the randomization strata.|Cochran-Mantel-Haenszel|||||||0.3314
72544134|NCT00210626|144618264|SUPERIORITY_OR_OTHER|||||||0.3807||95.0|||||ANCOVA|Covariate used is Baseline SF-36 PF Score. Baseline SF-36 PF Score was collected prior to the start of Procrit or Placebo treatment||The null hypothesis is that there is no difference between Procrit and Placebo in average SF-36 Physical Function Scores||||0.3807
72544135|NCT00210626|144618265|SUPERIORITY_OR_OTHER|||||||0.7038||95.0|||||Chi-squared|||||||0.7038
72544136|NCT02473510|144618266|SUPERIORITY_OR_OTHER||Rate Difference|0.4|||||TWO_SIDED|95.0|-5.2|2.6||||||||2.6|-5.2|
72544137|NCT02473510|144618267|SUPERIORITY_OR_OTHER||Rate Difference|16.7|||||TWO_SIDED|95.0|3.6|27.6||||||Up to Day 8||27.6|3.6|
72544138|NCT02473510|144618267|SUPERIORITY_OR_OTHER||Rate Difference|17.9|||||TWO_SIDED|95.0|4.4|29.3||||||Up to Day 15||29.3|4.4|
72578628|NCT04386616|144684614|SUPERIORITY||Difference in percentage of participants|-12.0|||||TWO_SIDED|95.0|-24.67|0.67|||||The difference in percentage of participants was calculated as the UTTR1147A Arm minus the Placebo Arm.|||0.67|-24.67|
72578629|NCT04386616|144684614|SUPERIORITY||Odds Ratio (OR)|0.86||||0.556|TWO_SIDED|95.0|0.53|1.41|||Chi-squared||The odds ratio was calculated as the MSTT1041A Arm relative to the Placebo Arm.|||1.41|0.53|0.5560
72544139|NCT01261325|144618276|SUPERIORITY_OR_OTHER_LEGACY||Percent reduction over PBO|22.8|||<|0.001|TWO_SIDED|95.0|13.3|31.2||"Type I error rate of 0.05 based on a Hochberg multiple comparison procedure would be considered statistically significant or similar, as accurate and appropriate."|ANCOVA|Effects of treatment, country, combination of LEV status and number of previous AEDs, and log-transformed baseline seizure frequency are in the model.||||31.2|13.3|<0.001
72544140|NCT01261325|144618276|SUPERIORITY_OR_OTHER_LEGACY||Percent reduction over PBO|23.2|||<|0.001|TWO_SIDED|95.0|13.8|31.6||Statistically significant with control of Type I error rate based on a Hochberg multiple comparison procedure.|ANCOVA|Effects of treatment, country, combination of LEV status and number of previous AEDs, and log-transformed baseline seizure frequency are in the model.||||31.6|13.8|<0.001
72544141|NCT01261325|144618277|SUPERIORITY_OR_OTHER_LEGACY||Odds ratio (BRV versus PBO)|2.39|||<|0.001|TWO_SIDED|95.0|1.6|3.6||Statistically significant with control of Type I error rate based on a Hochberg multiple comparison procedure.|Regression, Logistic|Effects of treatment, country, combination of LEV status and number of previous AEDs, and log-transformed baseline seizure frequency are in the model.||||3.6|1.6|<0.001
72544142|NCT01261325|144618277|SUPERIORITY_OR_OTHER_LEGACY||Odds ratio (BRV versus PBO)|2.19|||<|0.001|TWO_SIDED|95.0|1.5|3.3||Statistically significant with control of Type I error rate based on a Hochberg multiple comparison procedure.|Regression, Logistic|Effects of treatment, country, combination of LEV status and number of previous AEDs, and log-transformed baseline seizure frequency are in the model.||||3.3|1.5|<0.001
72544143|NCT01261325|144618278|SUPERIORITY_OR_OTHER_LEGACY||Median difference vs placebo|15.8|||<|0.001|TWO_SIDED|95.0|7.6|24.2||Statistically significant at a nominal 0.050 significance level.|Wilcoxon (Mann-Whitney)||Hodges-Lehmann non-parametric effect estimates and corresponding two-sided 95% confidence intervals are provided above.|||24.2|7.6|<0.001
72544144|NCT01261325|144618278|SUPERIORITY_OR_OTHER_LEGACY||Median difference vs placebo|18.1|||<|0.001|TWO_SIDED|95.0|10.4|26.4||Statistically significant at a nominal 0.050 significance level.|Wilcoxon (Mann-Whitney)||Hodges-Lehmann non-parametric effect estimates and corresponding two-sided 95% confidence intervals are provided above.|||26.4|10.4|<0.001
72544145|NCT01261325|144618282|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.67|||<|0.001|TWO_SIDED|95.0|0.56|0.82||Statistically significant at a nominal 0.050 significance level.|Semi-parametric hazards regression model|Effects of treatment, country, combination of LEV status and number of previous AEDs, and log-transformed baseline seizure frequency are in the model.|Hazard ratio is Brivaracetam versus Placebo.|||0.82|0.56|<0.001
72578630|NCT04386616|144684614|SUPERIORITY||Odds Ratio (OR)|0.62||||0.0502|TWO_SIDED|95.0|0.38|1.0|||Chi-squared||The odds ratio was calculated as the UTTR1147A Arm relative to the Placebo Arm.|||1.00|0.38|0.0502
72578631|NCT04386616|144684614|SUPERIORITY||Odds Ratio (OR)|0.91||||0.7002|TWO_SIDED|95.0|0.51|1.6|||Cochran-Mantel-Haenszel|The analysis was adjusted for the baseline characteristics of region of enrollment and need for mechanical ventilation.|The odds ratio was calculated as the MSTT1041A Arm relative to the Placebo Arm.|||1.60|0.51|0.7002
72578632|NCT04386616|144684614|SUPERIORITY||Odds Ratio (OR)|0.57||||0.0448|TWO_SIDED|95.0|0.32|0.99|||Cochran-Mantel-Haenszel|The analysis was adjusted for the baseline characteristics of region of enrollment and need for mechanical ventilation.|The odds ratio was calculated as the UTTR1147A Arm relative to the Placebo Arm.|||0.99|0.32|0.0448
72578633|NCT04386616|144684615|SUPERIORITY||Median Difference (Net)|-0.48||||0.4845|||||||Van Elteren||Median difference was calculated as the MSTT1041A Arm minus the Placebo Arm.|||||0.4845
72578634|NCT04386616|144684615|SUPERIORITY||Median Difference (Net)|-3.1||||0.057|||||||Van Elteren||Median difference was calculated as the UTTR1147A Arm minus the Placebo Arm.|||||0.0570
72578635|NCT04386616|144684616|SUPERIORITY||Hazard Ratio (HR)|1.19||||0.4456|TWO_SIDED|95.0|0.76|1.88|||Unstratified Log Rank||The hazard ratio was calculated as the MSTT1041A Arm relative to the Placebo Arm.|||1.88|0.76|0.4456
72578636|NCT04386616|144684616|SUPERIORITY||Hazard Ratio (HR)|0.92||||0.7213|TWO_SIDED|95.0|0.57|1.48|||Unstratified Log Rank||The hazard ratio was calculated as the UTTR1147A Arm relative to the Placebo Arm.|||1.48|0.57|0.7213
72578637|NCT04386616|144684616|SUPERIORITY||Hazard Ratio (HR)|1.22||||0.3963|TWO_SIDED|95.0|0.77|1.96|||Stratified Log Rank|The analysis was adjusted for the baseline characteristics of region of enrollment and need for mechanical ventilation.|The hazard ratio was calculated as the MSTT1041A Arm relative to the Placebo Arm.|||1.96|0.77|0.3963
72411333|NCT01722331|144330982|SUPERIORITY||Difference in percentages|52.1|||<|0.001|TWO_SIDED|95.0|44.8|58.5|||Cochran-Mantel-Haenszel|Stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.||||58.5|44.8|<0.001
72411334|NCT01722331|144330982|SUPERIORITY||Difference in percentages|50.9|||<|0.001|TWO_SIDED|95.0|43.6|57.4|||Cochran-Mantel-Haenszel|Stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.||||57.4|43.6|<0.001
72578638|NCT04386616|144684616|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.9174|TWO_SIDED|95.0|0.6|1.58|||Stratified Log Rank|The analysis was adjusted for the baseline characteristics of region of enrollment and need for mechanical ventilation.|The hazard ratio was calculated as the UTTR1147A Arm relative to the Placebo Arm.|||1.58|0.60|0.9174
72578639|NCT04386616|144684617|OTHER||Difference in Mortality Rates|2.49|||||TWO_SIDED|95.0|-4.51|9.49|||||The difference in mortality rates is calculated as the MSTT1041A Arm minus the Placebo Arm.|||9.49|-4.51|
72578640|NCT04386616|144684617|OTHER||Difference in Mortality Rates|2.36|||||TWO_SIDED|95.0|-4.58|9.31|||||The difference in mortality rates is calculated as the UTTR1147A Arm minus the Placebo Arm.|||9.31|-4.58|
72578641|NCT04386616|144684617|SUPERIORITY||Odds Ratio (OR)|1.46||||0.4336|TWO_SIDED|95.0|0.57|3.74|||Chi-squared||The odds ratio was calculated as the MSTT1041A Arm relative to the Placebo Arm.|||3.74|0.57|0.4336
72411335|NCT01722331|144330986|SUPERIORITY||Difference in percentages|32.9|||<|0.001|TWO_SIDED|95.0|26.8|38.8|||Cochran-Mantel-Haenszel|Stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.||||38.8|26.8|<0.001
72544146|NCT01261325|144618282|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.65|||<|0.001|TWO_SIDED|95.0|0.54|0.79||Statistically significant at a nominal 0.050 significance level.|Semi-parametric hazards regression model|Effects of treatment, country, combination of LEV status and number of previous AEDs, and log-transformed baseline seizure frequency are in the model.|Hazard ratio is Brivaracetam versus Placebo.|||0.79|0.54|<0.001
72544147|NCT01261325|144618283|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.65|||<|0.001|TWO_SIDED|95.0|0.53|0.8||Statistically significant at a nominal 0.050 significance level.|Semi-parametric hazards regression model|Effects of treatment, country, combination of LEV status and number of previous AEDs, and log-transformed baseline seizure frequency are in the model.|Hazard ratio is Brivaracetam versus Placebo.|||0.80|0.53|<0.001
72578642|NCT04386616|144684617|SUPERIORITY||Odds Ratio (OR)|1.43||||0.4543|TWO_SIDED|95.0|0.56|3.68|||Chi-squared||The odds ratio was calculated as the UTTR1147A Arm relative to the Placebo Arm.|||3.68|0.56|0.4543
72578643|NCT04386616|144684617|SUPERIORITY||Odds Ratio (OR)|1.46||||0.49|TWO_SIDED|95.0|0.54|3.97|||Cochran-Mantel-Haenszel|The analysis was adjusted for the baseline characteristics of region of enrollment and need for mechanical ventilation.|The odds ratio was calculated as the MSTT1041A Arm relative to the Placebo Arm.|||3.97|0.54|0.4900
72578644|NCT04386616|144684617|SUPERIORITY||Odds Ratio (OR)|1.58||||0.3595|TWO_SIDED|95.0|0.58|4.28|||Cochran-Mantel-Haenszel|The analysis was adjusted for the baseline characteristics of region of enrollment and need for mechanical ventilation.|The odds ratio was calculated as the UTTR1147A Arm relative to the Placebo Arm.|||4.28|0.58|0.3595
72578645|NCT04386616|144684618|OTHER||Difference in Mortality Rates|3.42|||||TWO_SIDED|95.0|-5.42|12.26|||||The difference in mortality rates is calculated as the MSTT1041A Arm minus the Placebo Arm.|||12.26|-5.42|
72578646|NCT04386616|144684618|OTHER||Difference in Mortality Rates|1.68|||||TWO_SIDED|95.0|-6.89|10.26|||||The difference in mortality rates is calculated as the UTTR1147A Arm minus the Placebo Arm.|||10.26|-6.89|
72578647|NCT04386616|144684618|SUPERIORITY||Odds Ratio (OR)|1.36||||0.4067|TWO_SIDED|95.0|0.66|2.8|||Chi-squared||The odds ratio was calculated as the MSTT1041A Arm relative to the Placebo Arm.|||2.80|0.66|0.4067
72578648|NCT04386616|144684618|SUPERIORITY||Odds Ratio (OR)|1.17||||0.6728|TWO_SIDED|95.0|0.56|2.46|||Chi-squared||The odds ratio was calculated as the UTTR1147A Arm relative to the Placebo Arm.|||2.46|0.56|0.6728
72578649|NCT04386616|144684618|SUPERIORITY||Odds Ratio (OR)|1.33||||0.5495|TWO_SIDED|95.0|0.62|2.87|||Cochran-Mantel-Haenszel|The analysis was adjusted for the baseline characteristics of region of enrollment and need for mechanical ventilation.|The odds ratio was calculated as the MSTT1041A Arm relative to the Placebo Arm.|||2.87|0.62|0.5495
72578650|NCT04386616|144684618|SUPERIORITY||Odds Ratio (OR)|1.24||||0.5551|TWO_SIDED|95.0|0.57|2.71|||Cochran-Mantel-Haenszel|The analysis was adjusted for the baseline characteristics of region of enrollment and need for mechanical ventilation.|The odds ratio was calculated as the UTTR1147A Arm relative to the Placebo Arm.|||2.71|0.57|0.5551
72578651|NCT04386616|144684619|SUPERIORITY||Hazard Ratio (HR)|1.31||||0.3831|TWO_SIDED|95.0|0.71|2.4|||Unstratified Log Rank||The hazard ratio was calculated as the MSTT1041A Arm relative to the Placebo Arm.|||2.40|0.71|0.3831
72578652|NCT04386616|144684619|SUPERIORITY||Hazard Ratio (HR)|1.18||||0.5925|TWO_SIDED|95.0|0.65|2.15|||Unstratified Log Rank||The hazard ratio was calculated as the UTTR1147A Arm relative to the Placebo Arm.|||2.15|0.65|0.5925
72411336|NCT01722331|144330986|SUPERIORITY||Difference in percentages|32.1|||<|0.001|TWO_SIDED|95.0|25.9|38.0|||Cochran-Mantel-Haenszel|Stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.||||38.0|25.9|<0.001
72578653|NCT04386616|144684619|SUPERIORITY||Hazard Ratio (HR)|1.11||||0.7487|TWO_SIDED|95.0|0.6|2.05|||Stratified Log Rank|The analysis was adjusted for the baseline characteristics of region of enrollment and need for mechanical ventilation.|The hazard ratio was calculated as the MSTT1041A Arm relative to the Placebo Arm.|||2.05|0.60|0.7487
72578654|NCT04386616|144684619|SUPERIORITY||Hazard Ratio (HR)|1.18||||0.6092|TWO_SIDED|95.0|0.63|2.21|||Stratified Log Rank|The analysis was adjusted for the baseline characteristics of region of enrollment and need for mechanical ventilation.|The hazard ratio was calculated as the UTTR1147A Arm relative to the Placebo Arm.|||2.21|0.63|0.6092
72578655|NCT00993421|144684631|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Mixed Models Analysis|||Hypothesis: Treatment with a combination of LY377604 + sibutramine for 24 weeks would result in weight loss that was significantly greater than treatment with either sibutramine or LY377604 alone.||||<0.001
72578656|NCT00993421|144684631|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Mixed Models Analysis|||Hypothesis: Treatment with a combination of LY377604 + sibutramine for 24 weeks would result in weight loss that was significantly greater than treatment with either sibutramine or LY377604 alone.||||<0.001
72578657|NCT00993421|144684631|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Mixed Models Analysis|||Hypothesis: Treatment with a combination of LY377604 + sibutramine for 24 weeks would result in weight loss that was significantly greater than treatment with either sibutramine or LY377604 alone.||||<0.001
72578658|NCT00993421|144684631|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Mixed Models Analysis|||Hypothesis: Treatment with a combination of LY377604 + sibutramine for 24 weeks would result in weight loss that was significantly greater than treatment with either sibutramine or LY377604 alone.||||<0.001
72578659|NCT00993421|144684631|SUPERIORITY_OR_OTHER|||||||0.041||95.0|||||Mixed Models Analysis|||Hypothesis: Treatment with a combination of LY377604 + sibutramine for 24 weeks would result in weight loss that was significantly greater than treatment with either sibutramine or LY377604 alone.||||0.041
72578660|NCT00993421|144684631|SUPERIORITY_OR_OTHER|||||||0.668||95.0|||||Mixed Models Analysis|||Hypothesis: Treatment with a combination of LY377604 + sibutramine for 24 weeks would result in weight loss that was significantly greater than treatment with either sibutramine or LY377604 alone.||||0.668
72578661|NCT00993421|144684631|SUPERIORITY_OR_OTHER|||||||0.437||95.0|||||Mixed Models Analysis|||Hypothesis: Treatment with a combination of LY377604 + sibutramine for 24 weeks would result in weight loss that was significantly greater than treatment with either sibutramine or LY377604 alone.||||0.437
72411337|NCT01722331|144330987|SUPERIORITY||Difference in percentages|12.7|||<|0.001|TWO_SIDED|95.0|8.3|17.2|||Cochran-Mantel-Haenszel|Stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.||||17.2|8.3|<0.001
72411338|NCT01722331|144330987|SUPERIORITY||Difference in percentages|12.7|||<|0.001|TWO_SIDED|95.0|8.0|17.3|||Cochran-Mantel-Haenszel|Stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.||||17.3|8.0|<0.001
72411339|NCT01722331|144330989|OTHER||Difference in least squares means|-7.7|||<|0.001|TWO_SIDED|95.0|-8.6|-6.8|||Constrained Longitudinal Data Analysis|Terms for time, the interaction of time by treatment, body weight (\<=90 kg, \>90 kg), and prior exposure to biologic therapy for psoriasis (yes/no).||||-6.8|-8.6|<0.001
72411340|NCT01722331|144330989|OTHER||Difference in least squares means|-7.4|||<|0.001|TWO_SIDED|95.0|-8.3|-6.5|||Constrained Longitudinal Data Analysis|Terms for time, the interaction of time by treatment, body weight (\<=90 kg, \>90 kg), and prior exposure to biologic therapy for psoriasis (yes/no).||||-6.5|-8.3|<0.001
72411341|NCT01722331|144330990|OTHER||Difference in percentages|38.9|||<|0.001|TWO_SIDED|95.0|31.9|45.4|||Cochran-Mantel-Haenszel|Stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.||||45.4|31.9|<0.001
72411342|NCT01722331|144330990|OTHER||Difference in percentages|36.1|||<|0.001|TWO_SIDED|95.0|29.3|42.5|||Cochran-Mantel-Haenszel|Stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.||||42.5|29.3|<0.001
72411343|NCT00262834|144330992|SUPERIORITY_OR_OTHER_LEGACY|||||||0.42||95.0|||||Wilcoxon (Mann-Whitney)|Wilcoxon rank-sum tests were used to compare the differences (post-pre) between groups.||||||0.42
72411344|NCT00262834|144330993|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank-sum tests were used to compare the differences (post-pre) between groups.||||||0.50
72411345|NCT00262834|144330994|OTHER|||||||0.24|||||||Wilcoxon (Mann-Whitney)|||||||0.24
72411346|NCT04564833|144330998|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
72411347|NCT04564833|144330998|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
72411348|NCT04564833|144330999|SUPERIORITY|||||||0.3954|||||||ANCOVA|||||||0.3954
72411349|NCT04564833|144330999|SUPERIORITY|||||||0.0682|||||||ANCOVA|||||||0.0682
72411350|NCT04564833|144331000|SUPERIORITY|||||||0.6755|||||||Fisher Exact|||||||0.6755
72544148|NCT01261325|144618283|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.58|||<|0.001|TWO_SIDED|95.0|0.47|0.71||Statistically significant at a nominal 0.050 significance level.|Semi-parametric hazards regression model|Effects of treatment, country, combination of LEV status and number of previous AEDs, and log-transformed baseline seizure frequency are in the model.|Hazard ratio is Brivaracetam versus Placebo.|||0.71|0.47|<0.001
72411351|NCT04564833|144331000|SUPERIORITY|||||||0.6758|||||||Fisher Exact|||||||0.6758
72411352|NCT04564833|144331001|SUPERIORITY||||||>|0.9999|||||||Fisher Exact|||||||>0.9999
72411353|NCT04564833|144331001|SUPERIORITY||||||>|0.9999|||||||Fisher Exact|||||||>0.9999
72411354|NCT04265755|144331013|OTHER|Adjusted analysis utilizes a logistic regression model which includes age, sex, dose switch, Baseline value of interest, and mPRS as covariates and presents the mPRS estimates.|Odds Ratio (OR)|1.01||||0.86|TWO_SIDED|95.0|0.9|1.13|||Regression, Logistic||Based on a 1 standard deviation increase in mPRS.|Odds of achieving at least 50% reduction from Baseline in mean MMD over months 4, 5, and 6 in relation to mPRS.||1.13|0.90|0.86
72411355|NCT00701389|144331031|NON_INFERIORITY_OR_EQUIVALENCE|If the upper bound of the 90% CI is less than 5 mmHg, the primary hypothesis would be supported.|Difference in Least Squares Means|1.5|||||TWO_SIDED|90.0|0.0|3.0|||Mixed Effect Model|||100 mg sumatriptan/600 mg telcagepant minus 100 mg sumatriptan/telcagepant placebo||3.0|0.0|
72411356|NCT00701389|144331032|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|1.2|||||TWO_SIDED|90.0|-0.2|2.7|||Mixed Effect Model|||sumatriptan placebo/600 mg telcagepant minus sumatriptan placebo/telcagepant placebo||2.7|-0.2|
72411357|NCT00618657|144331057|OTHER||Standard Error|0.03|||||TWO_SIDED|||||||||||||
72411358|NCT00618657|144331057|OTHER||Standard Error|0.03|||||TWO_SIDED|||||||||||||
72411359|NCT01762761|144331061|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|26.08|||<|0.001|TWO_SIDED|95.0|7.29|93.26|||Regression, Logistic|||||93.26|7.29|<0.001
72411360|NCT01762761|144331062|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|23.8|||<|0.001|TWO_SIDED|95.0|8.54|66.33|||Regression, Logistic|||||66.33|8.54|<0.001
72411361|NCT01762761|144331063|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|8.52|||<|0.001|TWO_SIDED|95.0|3.84|18.94|||Regression, Logistic|||||18.94|3.84|<0.001
72411362|NCT01762761|144331064|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.28||||0.001|TWO_SIDED|95.0|0.13|0.59|||Mixed Models Analysis|||||0.59|0.13|0.001
72411363|NCT01762761|144331065|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.59||||0.306|TWO_SIDED|95.0|0.21|1.64|||Mixed Models Analysis|||||1.64|0.21|0.306
72411364|NCT01762761|144331066|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|6.12|||<|0.001|TWO_SIDED|95.0|4.01|9.34|||Log Rank|||||9.34|4.01|<0.001
72411365|NCT01762761|144331067|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.13|||<|0.001|TWO_SIDED|95.0|0.05|0.37|||Regression, Logistic|||||0.37|0.05|<0.001
72578662|NCT00993421|144684631|SUPERIORITY_OR_OTHER|||||||0.249||95.0|||||Mixed Models Analysis|||Hypothesis: Treatment with a combination of LY377604 + sibutramine for 24 weeks would result in weight loss that was significantly greater than treatment with either sibutramine or LY377604 alone.||||0.249
72578663|NCT00352417|144684654|SUPERIORITY_OR_OTHER|||||||0.97|||||||t-test, 2 sided|Satterthwaite's method||||||0.97
72578664|NCT00352417|144684655|SUPERIORITY_OR_OTHER|||||||0.37|||||||t-test, 2 sided|Satterthwaite's method||||||0.37
72578665|NCT00352417|144684656|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|||||||<0.0001
72578666|NCT00352417|144684657|SUPERIORITY_OR_OTHER||||||<|0.01|||||||ANCOVA|ANCOVA was performed on the natural log transformed data||||||<0.01
72578667|NCT00352417|144684658|SUPERIORITY_OR_OTHER||||||<|0.01|||||||ANCOVA|||||||<0.01
72578668|NCT04034927|144684690|SUPERIORITY||Odds Ratio (OR)|0.707|||||TWO_SIDED|95.0|0.241|2.068|||||The numerator is the experimental arm (odds of response) and the denominator is the control arm (odds of response).|Odds ratio for experimental arm (O + T) response compared to control arm (O) response.||2.068|0.241|
72544149|NCT01261325|144618284|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.75||||0.009|TWO_SIDED|95.0|0.6|0.93||Statistically significant at a nominal 0.050 significance level.|Semi-parametric hazards regression model|Effects of treatment, country, combination of LEV status and number of previous AEDs, and log-transformed baseline seizure frequency are in the model.||||0.93|0.60|0.009
72544150|NCT01261325|144618284|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.68|||<|0.001|TWO_SIDED|95.0|0.55|0.85||Statistically significant at a nominal 0.050 significance level.|Semi-parametric hazards regression model|Effects of treatment, country, combination of LEV status and number of previous AEDs, and log-transformed baseline seizure frequency are in the model.||||0.85|0.55|<0.001
72544151|NCT02524106|144618289|OTHER||percentage difference|61.0||||0.028|TWO_SIDED||||||Mixed Models Analysis|||||||0.028
72544152|NCT02524106|144618290|OTHER||percentage difference|39.0||||0.096|TWO_SIDED||||||Mixed Models Analysis|||||||0.096
72544153|NCT00990561|144618292|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.0|||<|0.001|TWO_SIDED|95.0|||||t-test, 2 sided|||Null hypothesis = there is no difference between using ultravate once daily vs. twice daily||||<0.001
72544154|NCT02826603|144618293|SUPERIORITY||Odds Ratio (OR)|2.21|||<|0.0001|TWO_SIDED|95.0|1.72|2.84|||Regression, Logistic|||||2.84|1.72|<0.0001
72578669|NCT03996447|144684693|SUPERIORITY||Mean Difference (Final Values)|1.82|STANDARD_ERROR_OF_MEAN|0.03|<|0.0001|TWO_SIDED|95.0|1.76|1.88||To demonstrate the superiority, a statistically significant (one-sided p-value ≤0.025) positive difference in mean scores in border delineation, internal morphology and degree of contrast enhancement of lesions had to be met for 2 out of 3 readers.|t-test, 2 sided|||Criterion: Border delineation; Reader 1. The null hypothesis was that the difference in mean scores between Paired images and Pre-contrast images for each of the 3 co-primary criteria was equal to 0. The Null hypothesis was rejected if the difference was significantly different from zero with a type 1 error set at 0.025. To conclude the superiority of gadopiclenol-enhanced MRI, the null hypothesis had to be rejected for all co-criteria simultaneously and for at least 2 out of 3 readers.||1.88|1.76|<.0001
72578670|NCT03996447|144684693|SUPERIORITY||Mean Difference (Final Values)|1.9|STANDARD_ERROR_OF_MEAN|0.05|<|0.0001|TWO_SIDED|95.0|1.81|2.0||To demonstrate the superiority, a statistically significant (one-sided p-value ≤0.025) positive difference in mean scores in border delineation, internal morphology and degree of contrast enhancement of lesions had to be met for 2 out of 3 readers.|t-test, 2 sided|||Criterion: Border delineation; Reader 2. The null hypothesis was that the difference in mean scores between Paired images and Pre-contrast images for each of the 3 co-primary criteria was equal to 0. The Null hypothesis was rejected if the difference was significantly different from zero with a type 1 error at 0.025. To conclude the superiority of gadopiclenol-enhanced MRI, the null hypothesis had to be rejected for all co-criteria simultaneously.||2.00|1.81|<.0001
72578671|NCT03996447|144684693|SUPERIORITY||Mean Difference (Final Values)|1.36|STANDARD_ERROR_OF_MEAN|0.04|<|0.0001|TWO_SIDED|95.0|1.29|1.44||To demonstrate the superiority, a statistically significant (one-sided p-value ≤0.025) positive difference in mean scores in border delineation, internal morphology and degree of contrast enhancement of lesions had to be met for 2 out of 3 readers.|t-test, 2 sided|||Criterion: Border delineation; Reader 3. The null hypothesis was that the difference in mean scores between Paired images and Pre-contrast images for each of the 3 co-primary criteria was equal to 0. The Null hypothesis was rejected if the difference was significantly different from zero with a type 1 error at 0.025. To conclude the superiority of gadopiclenol-enhanced MRI, the null hypothesis had to be rejected for all co-criteria simultaneously.||1.44|1.29|<.0001
72578672|NCT03996447|144684693|SUPERIORITY||Mean Difference (Final Values)|2.26|STANDARD_ERROR_OF_MEAN|0.03|<|0.0001|TWO_SIDED|95.0|2.2|2.33||To demonstrate the superiority, a statistically significant (one-sided p-value ≤0.025) positive difference in mean scores in border delineation, internal morphology and degree of contrast enhancement of lesions had to be met for 2 out of 3 readers.|t-test, 2 sided|||Criterion: Internal morphology; Reader 1. The null hypothesis was that the difference in mean scores between Paired images and Pre-contrast images for each of the 3 co-primary criteria was equal to 0. The Null hypothesis was rejected if the difference was significantly different from zero with a type 1 error at 0.025. To conclude the superiority of gadopiclenol-enhanced MRI, the null hypothesis had to be rejected for all co-criteria simultaneously.||2.33|2.20|<.0001
72544155|NCT02826603|144618294|SUPERIORITY||Odds Ratio (OR)|2.1|||<|0.0001|TWO_SIDED|95.0|1.63|2.72|||Regression, Logistic|||||2.72|1.63|<0.0001
72544156|NCT02826603|144618295|SUPERIORITY||Odds Ratio (OR)|2.62|||<|0.0001|TWO_SIDED|95.0|1.89|3.62|||Regression, Logistic|||||3.62|1.89|<0.0001
72544157|NCT02826603|144618296|SUPERIORITY||Odds Ratio (OR)|3.53|||<|0.0001|TWO_SIDED|95.0|2.65|4.71|||Regression, Logistic|||||4.71|2.65|<0.0001
72544158|NCT02826603|144618297|SUPERIORITY||Odds Ratio (OR)|2.33|||<|0.0001|TWO_SIDED|95.0|1.8|3.01|||Regression, Logistic|||||3.01|1.80|<0.0001
72544159|NCT02826603|144618298|SUPERIORITY||Odds Ratio (OR)|2.57|||<|0.0001|TWO_SIDED|95.0|1.96|3.37|||Regression, Logistic|||||3.37|1.96|<0.0001
72544160|NCT02826603|144618299|SUPERIORITY||Odds Ratio (OR)|2.5|||<|0.0001|TWO_SIDED|95.0|1.89|3.31|||Regression, Logistic|||||3.31|1.89|<0.0001
72544161|NCT02826603|144618300|SUPERIORITY||Odds Ratio (OR)|2.86|||<|0.0001|TWO_SIDED|95.0|1.96|4.17|||Regression, Logistic|||||4.17|1.96|<0.0001
72544162|NCT02826603|144618301|SUPERIORITY||Odds Ratio (OR)|2.85|||<|0.0001|TWO_SIDED|95.0|2.19|3.71|||Regression, Logistic|||||3.71|2.19|<0.0001
72544163|NCT02826603|144618302|SUPERIORITY||Odds Ratio (OR)|1.84|||<|0.0001|TWO_SIDED|95.0|1.41|2.41|||Regression, Logistic|||||2.41|1.41|<0.0001
72544164|NCT03558997|144618334|SUPERIORITY||Least Square (LS) Mean Difference|4.73||||0.7185|TWO_SIDED|95.0|-21.023|30.487|||ANCOVA|A Multiple imputation (MI) method addressed missing values in AUC (percent change from baseline) - Seeds: 16115 and 51161 with imputation size 40.|The confidence interval (CI) with p-value was based on treatment difference (Dupilumab + SCIT vs SCIT) of the LS mean using analysis of covariance (ANCOVA) model with baseline measurement as covariate and the treatment as fixed factor.|||30.487|-21.023|0.7185
72544165|NCT03558997|144618335|SUPERIORITY||Least Square (LS) Mean Difference|0.3||||0.5438|TWO_SIDED|95.0|-0.661|1.254|||ANCOVA|A Multiple imputation (MI) method addressed missing values in AUC (percent change from baseline) - Seeds: 16115 and 51161 with imputation size 40.|The confidence interval (CI) with p-value was based on treatment difference (Dupilumab + SCIT vs SCIT) of the LS mean using analysis of covariance (ANCOVA) model with baseline measurement as covariate and the treatment as fixed factor.|||1.254|-0.661|0.5438
72544166|NCT03558997|144618336|SUPERIORITY||Least Square (LS) Mean Difference|0.03||||0.9559|TWO_SIDED|95.0|-0.877|0.928|||ANCOVA|A Multiple imputation (MI) method addressed missing values in AUC (percent change from baseline) - Seeds: 16115 and 51161 with imputation size 40.|The confidence interval (CI) with p-value was based on treatment difference (Dupilumab vs Placebo) of the LS mean using analysis of covariance (ANCOVA) model with baseline measurement as covariate and the treatment as fixed factor.|||0.928|-0.877|0.9559
72544167|NCT03558997|144618337|SUPERIORITY||Least Square (LS) Mean Difference|7.25||||0.5416|TWO_SIDED|95.0|-16.028|30.53|||ANCOVA|A Multiple imputation (MI) method addressed missing values in AUC (percent change from baseline) - Seeds: 16115 and 51161 with imputation size 40.|The confidence interval (CI) with p-value was based on treatment difference (Dupilumab vs Placebo) of the LS mean using analysis of covariance (ANCOVA) model with baseline measurement as covariate and the treatment as fixed factor.|||30.530|-16.028|0.5416
72544168|NCT03558997|144618338|SUPERIORITY||Least Square (LS) Mean Difference|-0.94||||0.0414|TWO_SIDED|95.0|-1.848|-0.037|||ANCOVA|A Multiple imputation (MI) method addressed missing values in AUC (percent change from baseline) - Seeds: 16115 and 51161 with imputation size 40.|The confidence interval (CI) with p-value was based on treatment difference (Dupilumab + SCIT vs Dupilumab) of LS mean difference using analysis of covariance (ANCOVA) model with baseline measurement as covariate and the treatment as fixed factor.|||-0.037|-1.848|0.0414
72544169|NCT03558997|144618339|SUPERIORITY||Least Square (LS) Mean Difference|-30.45||||0.0108|TWO_SIDED|95.0|-53.874|-7.034|||ANCOVA|A Multiple imputation (MI) method addressed missing values in AUC (percent change from baseline) - Seeds: 16115 and 51161 with imputation size 40.|The confidence interval (CI) with p-value was based on treatment difference (Dupilumab + SCIT vs Dupilumab) of LS mean difference using analysis of covariance (ANCOVA) model with baseline measurement as covariate and the treatment as fixed factor.|||-7.034|-53.874|0.0108
72544170|NCT03558997|144618340|SUPERIORITY||Median Difference|0.665||||0.1449|TWO_SIDED|95.0|-0.77|3.21|||ANCOVA||P-value was based on treatment differences of median change using rank based ANCOVA model with baseline measurement as covariate \& treatment as fixed factors. Median difference \& its 95% CI estimated with Hodges-Lehmann method.|||3.2100|-0.770|0.1449
72544171|NCT03558997|144618341|SUPERIORITY||Median Difference|335.3||||0.1231|TWO_SIDED|95.0|-551.47|1746.55|||ANCOVA||P-value was based on treatment differences of median change using rank based ANCOVA model with baseline measurement as covariate \& treatment as fixed factors. Median difference \& its 95% CI estimated with Hodges-Lehmann method.|||1746.55|-551.47|0.1231
72411366|NCT01762761|144331068|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|16.54||||0.008|TWO_SIDED|95.0|2.09|131.12|||Regression, Logistic|||||131.12|2.09|0.008
72411367|NCT01762761|144331069|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||van Elteren stratified rank test|||||||<0.001
72411368|NCT01762761|144331070|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||van Elteren stratified rank test|||||||<0.001
72544172|NCT03558997|144618342|SUPERIORITY||Median Difference|-13.325|||<|0.0001|TWO_SIDED|95.0|-23.94|-8.36|||ANCOVA||P-value was based on treatment differences of median change using rank based ANCOVA model with baseline measurement as covariate \& treatment as fixed factors. Median difference \& its 95% CI estimated with Hodges-Lehmann method.|||-8.3600|-23.9400|<0.0001
72544173|NCT03558997|144618343|SUPERIORITY||Median Difference|-134.6|||<|0.0001|TWO_SIDED|95.0|-205.51|-94.98|||ANCOVA||P-value was based on treatment differences of median change using rank based ANCOVA model with baseline measurement as covariate \& treatment as fixed factors. Median difference \& its 95% CI estimated with Hodges-Lehmann method.|||-94.98|-205.51|<0.0001
72544174|NCT03558997|144618344|SUPERIORITY||Median Difference|0.84|||<|0.0001|TWO_SIDED|95.0|0.45|1.27|||ANCOVA||P-value was based on treatment differences of median change using rank based ANCOVA model with baseline measurement as covariate \& treatment as fixed factors. Median difference \& its 95% CI estimated with Hodges-Lehmann method.|||1.2700|0.4500|<0.0001
72544175|NCT02033876|144618346|SUPERIORITY|||||||0.43|||||||ANCOVA|||||||0.43
72544176|NCT02033876|144618347|SUPERIORITY|||||||0.65|||||||ANCOVA|||||||0.65
72544177|NCT02033876|144618349|SUPERIORITY|||||||0.37|||||||ANCOVA|||||||0.37
72544178|NCT02033876|144618350|SUPERIORITY|||||||0.51|||||||ANCOVA|||||||0.51
72544179|NCT02033876|144618351|SUPERIORITY|||||||0.4|||||||ANCOVA|||||||0.4
72544180|NCT02033876|144618352|SUPERIORITY|||||||0.8|||||||ANCOVA|||||||0.8
72544181|NCT02033876|144618353|SUPERIORITY|||||||0.006|||||||ANCOVA|||||||0.006
72544182|NCT01360632|144618358|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.19||||0.0925|TWO_SIDED|95.0|-2.58|0.2|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||The primary analysis was performed on the Efficacy Sample by fitting a Mixed Model Repeated Measures (MMRM) analysis with an unstructured variance covariance structure in which the change from the end of Phase A (Week 8) in MADRS Total Score (at Weeks 9 to 14) was the dependent variable. The model included fixed class effect terms for treatment, trial site, visit week, and an interaction term of treatment by visit week.||0.2|-2.58|0.0925
72544183|NCT01360632|144618358|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.52||||0.0327|TWO_SIDED|95.0|-2.92|-0.13|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||The primary analysis was performed on the Efficacy Sample by fitting a MMRM analysis with an unstructured variance covariance structure in which the change from the end of Phase A (Week 8) in MADRS Total Score (at Weeks 9 to 14) was the dependent variable. The model included fixed class effect terms for treatment, trial site, visit week, and an interaction term of treatment by visit week.||-0.13|-2.92|0.0327
72544184|NCT01360632|144618359|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.3||||0.0737|TWO_SIDED|95.0|-2.73|0.13|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.||0.13|-2.73|0.0737
72544185|NCT01360632|144618359|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.95||||0.0079|TWO_SIDED|95.0|-3.39|-0.51|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.||-0.51|-3.39|0.0079
72544186|NCT01360632|144618360|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.06||||0.0096|TWO_SIDED|95.0|-1.86|-0.26|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis at Week 9. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.||-0.26|-1.86|0.0096
72544187|NCT01360632|144618360|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.33||||0.4137|TWO_SIDED|95.0|-1.14|0.47|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis at Week 9. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.||0.47|-1.14|0.4137
72544188|NCT01360632|144618360|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.44||||0.0065|TWO_SIDED|95.0|-2.47|-0.4|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate||Statistical analysis at Week 10. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.||-0.4|-2.47|0.0065
72544189|NCT01360632|144618360|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.89||||0.0914|TWO_SIDED|95.0|-1.93|0.14|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis at Week 10. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.||0.14|-1.93|0.0914
72411369|NCT01381172|144331105|OTHER|The primary analysis employed a Bayesian repeated measures linear model to estimate group differences in mean pVO2 at 24 weeks from baseline, with 30% borrowing of information (70% down-weighting) from the corresponding treatment group difference observed in the FIX-5 study subgroup. The Bayesian posterior probability would need to be \> 0.975 to be considered a positive result with statistical significance.||||||0.975||||||The posterior probability (Pr) that the mean difference in pVO2 (Δ3) between device and control groups is greater than zero must exceed 0.975 to meet the primary effectiveness endpoint.|Bayesian posterior probability|||The FIX-HF-5C Study was a study designed to confirm the preliminary evidence reported in the FIX-HF-5 subgroup analysis demonstrating improvement in subjects with LVEF 25-45% and NYHA class III-IV. A Bayesian statistical approach was employed to leverage the data available, particularly the pVO2 results, from the FIX-HF-5 subgroup.||||0.975
72411370|NCT04079933|144331119|EQUIVALENCE|Null hypothesis = Test and Control groups will have equivalent levels of percent change from baseline in urinary total NNAL; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of percent change from baseline in urinary total NNAL|Mean Difference (Net)|-12.6||||0.2347|TWO_SIDED|95.0|-33.5|8.27|||t-test, 2 sided||"Difference in Least Square (LS) means (Test - Control) using Mixed Effects Repeated Measures Model 1:~Percent Change from baseline = study group + visit + study group\*visit + subject + random error, fitted with unstructured covariance matrix."|Null hypothesis = Test and Control groups will have equivalent levels of percent change from baseline in urinary total NNAL; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of percent change from baseline in urinary total NNAL||8.27|-33.5|0.2347
72411371|NCT04079933|144331119|EQUIVALENCE|Null hypothesis = Test and Control groups will have equivalent levels of percent change from baseline in urinary total NNAL; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of percent change from baseline in urinary total NNAL|Mean Difference (Net)|-11.9||||0.2905|TWO_SIDED|95.0|-33.9|10.2|||t-test, 2 sided||"Difference in LS means (Test - Control) using Mixed Effects Repeated Measures Model 2:~%Change from baseline = study group +visit +study group\*visit +CPD +Sex +Race +BMI +Age +subject +random error, fitted with unstructured covariance matrix."|Null hypothesis = Test and Control groups will have equivalent levels of percent change from baseline in urinary total NNAL; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of percent change from baseline in urinary total NNAL||10.2|-33.9|0.2905
72411372|NCT04079933|144331120|EQUIVALENCE|Null hypothesis = Test and Control groups will have equivalent levels of change from baseline in urinary total NNAL; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of change from baseline to end of study in urinary total NNAL|Mean Difference (Net)|-3.72||||0.9433|TWO_SIDED|95.0|-107.0|99.4|||t-test, 2 sided||"Difference in LS means (Test - Control) using Mixed Effects Repeated Measures Model 1:~Change from baseline = study group + visit + study group\*visit + subject +random error, fitted with unstructured covariance matrix"|Null hypothesis = Test and Control groups will have equivalent levels of change from baseline in urinary total NNAL; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of change from baseline to end of study in urinary total NNAL||99.4|-107|0.9433
72578673|NCT03996447|144684693|SUPERIORITY||Mean Difference (Final Values)|1.77|STANDARD_ERROR_OF_MEAN|0.04|<|0.0001|TWO_SIDED|95.0|1.69|1.85||To demonstrate the superiority, a statistically significant (one-sided p-value ≤0.025) positive difference in mean scores in border delineation, internal morphology and degree of contrast enhancement of lesions had to be met for 2 out of 3 readers.|t-test, 2 sided|||Criterion: Internal morphology; Reader 2. The null hypothesis was that the difference in mean scores between Paired images and Pre-contrast images for each of the 3 co-primary criteria was equal to 0. The Null hypothesis was rejected if the difference was significantly different from zero with a type 1 error at 0.025. To conclude the superiority of gadopiclenol-enhanced MRI, the null hypothesis had to be rejected for all co-criteria simultaneously.||1.85|1.69|<.0001
72578674|NCT03996447|144684693|SUPERIORITY||Mean Difference (Final Values)|1.96|STANDARD_ERROR_OF_MEAN|0.05|<|0.0001|TWO_SIDED|95.0|1.85|2.06||To demonstrate the superiority, a statistically significant (one-sided p-value ≤0.025) positive difference in mean scores in border delineation, internal morphology and degree of contrast enhancement of lesions had to be met for 2 out of 3 readers.|t-test, 2 sided|||Criterion: Internal morphology; Reader 3. The null hypothesis was that the difference in mean scores between Paired images and Pre-contrast images for each of the 3 co-primary criteria was equal to 0. The Null hypothesis was rejected if the difference was significantly different from zero with a type 1 error at 0.025. To conclude the superiority of gadopiclenol-enhanced MRI, the null hypothesis had to be rejected for all co-criteria simultaneously.||2.06|1.85|<.0001
72578675|NCT03996447|144684693|SUPERIORITY||Mean Difference (Final Values)|2.77|STANDARD_ERROR_OF_MEAN|0.04|<|0.0001|TWO_SIDED|95.0|2.69|2.85||To demonstrate the superiority, a statistically significant (one-sided p-value ≤0.025) positive difference in mean scores in border delineation, internal morphology and degree of contrast enhancement of lesions had to be met for 2 out of 3 readers.|t-test, 2 sided|||Criterion: Contrast enhancement; Reader 1. The null hypothesis was that the difference in mean scores between Paired images and Pre-contrast images for each of the 3 co-primary criteria was equal to 0. The Null hypothesis was rejected if the difference was significantly different from zero with a type 1 error at 0.025. To conclude the superiority of gadopiclenol-enhanced MRI, the null hypothesis had to be rejected for all co-criteria simultaneously.||2.85|2.69|<.0001
72578676|NCT03996447|144684693|SUPERIORITY||Mean Difference (Final Values)|2.58|STANDARD_ERROR_OF_MEAN|0.05|<|0.0001|TWO_SIDED|95.0|2.49|2.67||To demonstrate the superiority, a statistically significant (one-sided p-value ≤0.025) positive difference in mean scores in border delineation, internal morphology and degree of contrast enhancement of lesions had to be met for 2 out of 3 readers.|t-test, 2 sided|||Criterion: Contrast enhancement - Reader 2. The null hypothesis was that the difference in mean scores between Paired images and Pre-contrast images for each of the 3 co-primary criteria was equal to 0. The Null hypothesis was rejected if the difference was significantly different from zero with a type 1 error at 0.025. To conclude the superiority of gadopiclenol-enhanced MRI, the null hypothesis had to be rejected for all co-criteria simultaneously.||2.67|2.49|<.0001
72578677|NCT03996447|144684693|SUPERIORITY||Mean Difference (Final Values)|2.9|STANDARD_ERROR_OF_MEAN|0.03|<|0.0001|TWO_SIDED|95.0|2.84|2.95||To demonstrate the superiority, a statistically significant (one-sided p-value ≤0.025) positive difference in mean scores in border delineation, internal morphology and degree of contrast enhancement of lesions had to be met for 2 out of 3 readers.|t-test, 2 sided|||Criterion: Contrast enhancement; Reader 3. The null hypothesis was that the difference in mean scores between Paired images and Pre-contrast images for each of the 3 co-primary criteria was equal to 0. The Null hypothesis was rejected if the difference was significantly different from zero with a type 1 error at 0.025. To conclude the superiority of gadopiclenol-enhanced MRI, the null hypothesis had to be rejected for all co-criteria simultaneously.||2.95|2.84|<.0001
72578678|NCT03996447|144684694|NON_INFERIORITY|Non-inferiority between gadopiclenol and gadobutrol was concluded if the lower bound of this confidence interval was above the non-inferiority margin set to 0.35 for at least 2 out of 3 blinded readers and for the 3 co-primary criteria simultaneously.|Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001|TWO_SIDED|95.0|-0.06|0.02||The Null hypothesis was rejected if the 2-sided 95% Confidence Interval (CI) for the difference \[gadopiclenol scores mean - gadobutrol scores mean\] had its lower limit above -0.35.|t-test, 2 sided|The Student's t-based 95% CIs of the difference between gadopiclenol and gadobutrol were constructed for each of 3 co-primary criteria.||Criterion: Border delineation; Reader 1. The null hypothesis was that the difference in mean scores between gadopiclenol and gadobutrol for each of the 3 primary criteria was equal to the non inferiority margin (-0.35). The alternative hypothesis was that the difference in mean scores between gadopiclenol and gadobutrol for each of the 3 co-primary criteria was greater than the non inferiority margin.||0.02|-0.06|<0.0001
72578679|NCT03996447|144684694|NON_INFERIORITY|Non-inferiority between gadopiclenol and gadobutrol was concluded if the lower bound of this confidence interval was above the non-inferiority margin set to 0.35 for at least 2 out of 3 blinded readers and for the 3 co-primary criteria simultaneously.|Mean Difference (Final Values)|0.03|STANDARD_ERROR_OF_MEAN|0.04|<|0.0001|TWO_SIDED|95.0|-0.04|0.11||The Null hypothesis was rejected if the 2-sided 95% Confidence Interval (CI) for the difference \[gadopiclenol scores mean - gadobutrol scores mean\] had its lower limit above -0.35.|t-test, 2 sided|The Student's t-based 95% CIs of the difference between gadopiclenol and gadobutrol were constructed for each of 3 co-primary criteria.||Criterion: Border delineation; Reader 2. The null hypothesis was that the difference in mean scores between gadopiclenol and gadobutrol for each of the 3 primary criteria was equal to the non inferiority margin (-0.35). The alternative hypothesis was that the difference in mean scores between gadopiclenol and gadobutrol for each of the 3 co-primary criteria was greater than the non inferiority margin.||0.11|-0.04|<0.0001
72578680|NCT03996447|144684694|NON_INFERIORITY|Non-inferiority margin : -0.35|Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001|TWO_SIDED|95.0|-0.01|0.05|||t-test, 2 sided|||Criterion: Border delineation; Reader 3||0.05|-0.01|<0.0001
72578681|NCT03996447|144684694|NON_INFERIORITY|Non-inferiority margin : -0.35|Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001|TWO_SIDED|95.0|-0.04|0.03|||t-test, 2 sided|||Criterion: Internal morphology; Reader 1||0.03|-0.04|<0.0001
72578682|NCT03996447|144684694|NON_INFERIORITY|Non-inferiority margin : -0.35|Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.03|<|0.0001|TWO_SIDED|95.0|-0.05|0.09|||t-test, 2 sided|||Criterion: Internal morphology; Reader 2||0.09|-0.05|<0.0001
72578683|NCT03996447|144684694|NON_INFERIORITY|Non-inferiority margin : -0.35|Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001|TWO_SIDED|95.0|0.01|0.08|||t-test, 2 sided|||Criterion: Internal morphology; Reader 3||0.08|0.01|<0.0001
72578684|NCT03996447|144684694|NON_INFERIORITY|Non-inferiority margin : -0.35|Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.03||0.0001|TWO_SIDED|95.0|-0.04|0.07|||t-test, 2 sided|||Criterion: Contrast enhancement; Reader 1||0.07|-0.04|0.0001
72578685|NCT03996447|144684694|NON_INFERIORITY|Non-inferiority margin : -0.35|Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.04|<|0.0001|TWO_SIDED|95.0|-0.03|0.12|||t-test, 2 sided|||Criterion: Contrast enhancement; Reader 2||0.12|-0.03|<0.0001
72578686|NCT03996447|144684694|NON_INFERIORITY|Non-inferiority margin : -0.35|Mean Difference (Final Values)|0.09|STANDARD_ERROR_OF_MEAN|0.03|<|0.0001|TWO_SIDED|95.0|0.03|0.15|||t-test, 2 sided|||Criterion: Contrast enhancement; Reader 3||0.15|0.03|<0.0001
72578687|NCT01009814|144684700|OTHER||Mean Difference (Net)|-0.1089|STANDARD_ERROR_OF_MEAN|0.212||0.6102|TWO_SIDED|90.0|-0.4656|0.2477|||ANCOVA|||Null hypothesis was that there was 0 difference in mean log10 decrease in HIV RNA at Day 9 between two groups.||0.2477|-0.4656|0.6102
72578688|NCT01009814|144684700|OTHER||Mean Difference (Net)|-0.1266|STANDARD_ERROR_OF_MEAN|0.2076||0.5452|TWO_SIDED|90.0|-0.4758|0.2225|||ANCOVA|||Null hypothesis was that there was 0 difference in mean log10 decrease in HIV RNA at Day 9 between two groups.||0.2225|-0.4758|0.5452
72578689|NCT01009814|144684700|OTHER||Mean Difference (Net)|-0.1682|STANDARD_ERROR_OF_MEAN|0.2055||0.4178|TWO_SIDED|90.0|-0.5139|0.1775|||ANCOVA|||Null hypothesis was that there was 0 difference in mean log10 decrease in HIV RNA at Day 9 between two groups.||0.1775|-0.5139|0.4178
72578690|NCT01009814|144684700|OTHER||Mean Difference (Net)|-0.4885|STANDARD_ERROR_OF_MEAN|0.2075||0.0233|TWO_SIDED|90.0|-0.8375|-0.1395|||ANCOVA|||Null hypothesis was that there was 0 difference in mean log10 decrease in HIV RNA at Day 9 between two groups.||-0.1395|-0.8375|0.0233
72578691|NCT01009814|144684700|OTHER||Mean Difference (Net)|-0.0177|STANDARD_ERROR_OF_MEAN|0.2043||0.9314|TWO_SIDED|90.0|-0.3613|0.3259|||ANCOVA|||Null hypothesis was that there was 0 difference in mean log10 decrease in HIV RNA at Day 9 between two groups.||0.3259|-0.3613|0.9314
72578692|NCT01009814|144684700|OTHER||Mean Difference (Net)|-0.0592|STANDARD_ERROR_OF_MEAN|0.2045||0.7734|TWO_SIDED|90.0|-0.4032|0.2847|||ANCOVA|||Null hypothesis was that there was 0 difference in mean log10 decrease in HIV RNA at Day 9 between two groups.||0.2847|-0.4032|0.7734
72578693|NCT01009814|144684700|OTHER||Mean Difference (Net)|-0.3796|STANDARD_ERROR_OF_MEAN|0.2043||0.0702|TWO_SIDED|90.0|-0.7232|-0.036|||ANCOVA|||Null hypothesis was that there was 0 difference in mean log10 decrease in HIV RNA at Day 9 between two groups.||-0.0360|-0.7232|0.0702
72578694|NCT01009814|144684700|OTHER||Mean Difference (Net)|-0.0415|STANDARD_ERROR_OF_MEAN|0.1993||0.8359|TWO_SIDED|90.0|-0.3768|0.2937|||ANCOVA|||Null hypothesis was that there was 0 difference in mean log10 decrease in HIV RNA at Day 9 between two groups.||0.2937|-0.3768|0.8359
72578695|NCT01009814|144684700|OTHER||Mean Difference (Net)|-0.3619|STANDARD_ERROR_OF_MEAN|0.1988||0.0759|TWO_SIDED|90.0|-0.6962|-0.0275|||ANCOVA|||Null hypothesis was that there was 0 difference in mean log10 decrease in HIV RNA at Day 9 between two groups.||-0.0275|-0.6962|0.0759
72411373|NCT04079933|144331120|EQUIVALENCE|Null hypothesis = Test and Control groups will have equivalent levels of change from baseline in urinary total NNAL; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of change from baseline in urinary total NNAL|Mean Difference (Net)|-12.2||||0.8264|TWO_SIDED|95.0|-122.0|97.5|||t-test, 2 sided||"Difference in LS means (Test - Control) using Mixed Effects Repeated Measures Model 2:~Change from baseline= study group + visit + study group\*visit + CPD + Sex + Race + BMI + Age + subject + random error, fitted with unstructured covariance matrix"|Null hypothesis = Test and Control groups will have equivalent levels of change from baseline in urinary total NNAL; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of change from baseline in urinary total NNAL||97.5|-122|0.8264
72411374|NCT04079933|144331121|EQUIVALENCE|Null hypothesis = Test and Control groups will have equivalent levels of change from baseline in nicotine equivalents; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of change from baseline in nicotine equivalents|Mean Difference (Net)|-1.13||||0.4903|TWO_SIDED|95.0|-4.35|2.1|||t-test, 2 sided||"Difference in LS means (Test - Control) using Mixed Effects Repeated Measures Model 1:~Change from baseline = study group + visit + study group\*visit + subject +random error, fitted with unstructured covariance matrix"|Null hypothesis = Test and Control groups will have equivalent levels of change from baseline in nicotine equivalents; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of change from baseline in nicotine equivalents||2.10|-4.35|0.4903
72411375|NCT04079933|144331121|EQUIVALENCE|Null hypothesis = Test and Control groups will have equivalent levels of change from baseline in nicotine equivalents; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of change from baseline in nicotine equivalents|Mean Difference (Net)|-1.4||||0.4251|TWO_SIDED|95.0|-4.88|2.07|||t-test, 2 sided||"Difference in LS means (Test - Control) using Mixed Effects Repeated Measures Model 2:~Change from baseline= study group + visit + study group\*visit + CPD + Sex + Race + BMI + Age + subject + random error, fitted with unstructured covariance matrix"|Null hypothesis = Test and Control groups will have equivalent levels of change from baseline in nicotine equivalents; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of change from baseline in nicotine equivalents||2.07|-4.88|0.4251
72411376|NCT04079933|144331122|EQUIVALENCE|Null hypothesis = Test and Control groups will have equivalent levels of percent change from baseline to end of study in nicotine equivalents; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of percent change from baseline to end of study in nicotine equivalents|Mean Difference (Net)|-9.83||||0.406|TWO_SIDED|95.0|-33.2|13.5|||t-test, 2 sided||"Difference in Least Square means (Test - Control) using Mixed Effects Repeated Measures Model 1:~Percent Change from baseline = study group + visit + study group\*visit + subject + random error, fitted with unstructured covariance matrix."|Null hypothesis = Test and Control groups will have equivalent levels of percent change from baseline to end of study in nicotine equivalents; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of percent change from baseline to end of study in nicotine equivalents||13.5|-33.2|0.4060
72411377|NCT04079933|144331122|EQUIVALENCE|Null hypothesis = Test and Control groups will have equivalent levels of percent change from baseline to end of study in nicotine equivalents; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of percent change from baseline to end of study in nicotine equivalents|Mean Difference (Net)|-10.3||||0.4165|TWO_SIDED|95.0|-35.4|14.7|||t-test, 2 sided||"Difference in LS means (Test - Control) using Mixed Effects Repeated Measures Model 2:~%Change from baseline = study group +visit +study group\*visit +CPD +Sex +Race +BMI +Age +subject +random error, fitted with unstructured covariance matrix."|Null hypothesis = Test and Control groups will have equivalent levels of percent change from baseline to end of study in nicotine equivalents; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of percent change from baseline to end of study in nicotine equivalents||14.7|-35.4|0.4165
72411378|NCT04079933|144331123|EQUIVALENCE|Null hypothesis = Test and Control groups will have equivalent levels of change from baseline in S-PMA; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of change from baseline in S-PMA|Mean Difference (Net)|-269.0||||0.724|TWO_SIDED|95.0|-1773.0|1235.0|||t-test, 2 sided||"Difference in LS means (Test - Control) using Mixed Effects Repeated Measures Model 1:~Change from baseline = study group + visit + study group\*visit + subject +random error, fitted with unstructured covariance matrix"|Null hypothesis = Test and Control groups will have equivalent levels of change from baseline in S-PMA; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of change from baseline in S-PMA||1235|-1773|0.7240
72411379|NCT04079933|144331123|EQUIVALENCE|Null hypothesis = Test and Control groups will have equivalent levels of change from baseline in S-PMA; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of change from baseline in S-PMA|Mean Difference (Net)|50.5||||0.9508|TWO_SIDED|95.0|-1566.0|1667.0|||t-test, 2 sided||"Difference in LS means (Test - Control) using Mixed Effects Repeated Measures Model 2:~Change from baseline= study group + visit + study group\*visit + CPD + Sex + Race + BMI + Age + subject + random error, fitted with unstructured covariance matrix"|Null hypothesis = Test and Control groups will have equivalent levels of change from baseline in S-PMA; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of change from baseline in S-PMA||1667|-1566|0.9508
72578696|NCT01009814|144684700|OTHER||Mean Difference (Net)|-0.3203|STANDARD_ERROR_OF_MEAN|0.1993||0.1155|TWO_SIDED|90.0|-0.6555|0.0149|||ANCOVA|||Null hypothesis was that there was 0 difference in mean log10 decrease in HIV RNA at Day 9 between two groups.||0.0149|-0.6555|0.1155
72578697|NCT01644617|144684744|SUPERIORITY_OR_OTHER||Difference in Least Squares Means (LSM)|-3.62|||<|0.001|TWO_SIDED|95.0|-4.85|-2.39|||ANCOVA||Analysis by ANCOVA with treatment and baseline endpoint score as fixed effects and adjusted for different error variation for each treatment group.|||-2.39|-4.85|<0.001
72578698|NCT01644617|144684744|SUPERIORITY_OR_OTHER||Difference in LSM|-1.98||||0.003|TWO_SIDED|95.0|-3.24|-0.72|||ANCOVA||Analysis by ANCOVA with treatment and baseline endpoint score as fixed effects and adjusted for different error variation for each treatment group.|||-0.72|-3.24|0.003
72578699|NCT01644617|144684745|SUPERIORITY_OR_OTHER||Difference in LSM|-2.08|||<|0.001|TWO_SIDED|95.0|-3.14|-1.03|||ANCOVA||Analysis by ANCOVA with treatment and baseline endpoint score as fixed effects and adjusted for different error variation for each treatment group.|||-1.03|-3.14|<0.001
72578700|NCT01644617|144684745|SUPERIORITY_OR_OTHER||Difference in LSM|-1.23||||0.032||95.0|-2.36|-0.11|||ANCOVA||Analysis by ANCOVA with treatment and baseline endpoint score as fixed effects and adjusted for different error variation for each treatment group.|||-0.11|-2.36|0.032
72578701|NCT01644617|144684746|SUPERIORITY_OR_OTHER||Difference in LSM|-1.37||||0.007|TWO_SIDED|95.0|-2.34|-0.39|||ANCOVA||Analysis by ANCOVA with treatment and baseline endpoint score as fixed effects and adjusted for different error variation for each treatment group.|||-0.39|-2.34|0.007
72578702|NCT01644617|144684746|SUPERIORITY_OR_OTHER||Difference in LSM|-0.54||||0.198|TWO_SIDED|95.0|-1.38|0.29|||ANCOVA||Analysis by ANCOVA with treatment and baseline endpoint score as fixed effects and adjusted for different error variation for each treatment group.|||0.29|-1.38|0.198
72578703|NCT01644617|144684747|SUPERIORITY_OR_OTHER||Difference in LSM|-4.84|||<|0.001|TWO_SIDED|95.0|-6.59|-3.09|||ANCOVA||Analysis by ANCOVA with treatment and baseline endpoint score as fixed effects and adjusted for different error variation for each treatment group.|||-3.09|-6.59|<0.001
72578704|NCT01644617|144684747|SUPERIORITY_OR_OTHER||Difference in LSM|-2.65||||0.003|TWO_SIDED|95.0|-4.35|-0.95|||ANCOVA||Analysis by ANCOVA with treatment and baseline endpoint score as fixed effects and adjusted for different error variation for each treatment group.|||-0.95|-4.35|0.003
72578705|NCT01644617|144684748|SUPERIORITY_OR_OTHER||Difference in LSM|-2.62|||<|0.001|TWO_SIDED|95.0|-4.12|-1.13|||ANCOVA||Analysis by ANCOVA with treatment and baseline endpoint score as fixed effects and adjusted for different error variation for each treatment group.|||-1.13|-4.12|<0.001
72578706|NCT01644617|144684748|SUPERIORITY_OR_OTHER||Difference in LSM|-1.37||||0.091|TWO_SIDED|95.0|-2.96|0.22|||ANCOVA||Analysis by ANCOVA with treatment and baseline endpoint score as fixed effects and adjusted for different error variation for each treatment group.|||0.22|-2.96|0.091
72578707|NCT01644617|144684749|SUPERIORITY_OR_OTHER||Difference in LSM|-1.97||||0.004|TWO_SIDED|95.0|-3.3|-0.64|||ANCOVA||Analysis by ANCOVA with treatment and baseline endpoint score as fixed effects and adjusted for different error variation for each treatment group.|||-0.64|-3.30|0.004
72578708|NCT01644617|144684749|SUPERIORITY_OR_OTHER||Difference in LSM|-0.83||||0.181|TWO_SIDED|95.0|-2.06|0.4|||ANCOVA||Analysis by ANCOVA with treatment and baseline endpoint score as fixed effects and adjusted for different error variation for each treatment group.|||0.40|-2.06|0.181
72578709|NCT01644617|144684750|SUPERIORITY_OR_OTHER||Difference in LSM|-1.27|||<|0.001|TWO_SIDED|95.0|-1.92|-0.62|||ANCOVA||Analysis by ANCOVA with treatment and baseline endpoint score as fixed effects and adjusted for different error variation for each treatment group.|||-0.62|-1.92|<0.001
72578710|NCT01644617|144684750|SUPERIORITY_OR_OTHER||Difference in LSM|-0.77||||0.023|TWO_SIDED|95.0|-1.43|-0.11|||ANCOVA||Analysis by ANCOVA with treatment and baseline endpoint score as fixed effects and adjusted for different error variation for each treatment group.|||-0.11|-1.43|0.023
72578711|NCT01644617|144684751|SUPERIORITY_OR_OTHER||Difference in LSM|-0.53||||0.082|TWO_SIDED|95.0|-1.13|0.07|||ANCOVA||Analysis by ANCOVA with treatment and baseline endpoint score as fixed effects and adjusted for different error variation for each treatment group.|||0.07|-1.13|0.082
72578712|NCT01644617|144684751|SUPERIORITY_OR_OTHER||Difference in LSM|-0.13||||0.691|TWO_SIDED|95.0|-0.79|0.52|||ANCOVA||Analysis by ANCOVA with treatment and baseline endpoint score as fixed effects and adjusted for different error variation for each treatment group.|||0.52|-0.79|0.691
72578713|NCT01644617|144684752|SUPERIORITY_OR_OTHER||Difference in LSM|-0.61||||0.023|TWO_SIDED|95.0|-1.14|-0.09|||ANCOVA||Analysis by ANCOVA with treatment and baseline endpoint score as fixed effects and adjusted for different error variation for each treatment group.|||-0.09|-1.14|0.023
72578714|NCT01644617|144684752|SUPERIORITY_OR_OTHER||Difference in LSM|-0.34||||0.235|TWO_SIDED|95.0|-0.9|0.22|||ANCOVA||Analysis by ANCOVA with treatment and baseline endpoint score as fixed effects and adjusted for different error variation for each treatment group.|||0.22|-0.90|0.235
72578715|NCT01644617|144684755|SUPERIORITY_OR_OTHER||Difference in LSM: D. pteronyssinus|0.55|||<|0.001|TWO_SIDED|95.0|0.43|0.68|||ANOVA||Analysis by ANOVA with treatment as fixed effect and adjusted for different error variation for each treatment group.|||0.68|0.43|<0.001
72578716|NCT01644617|144684755|SUPERIORITY_OR_OTHER||Difference in LSM: D. pteronyssinus|0.42|||<|0.001|TWO_SIDED|95.0|0.33|0.52|||ANOVA||Analysis by ANOVA with treatment as fixed effect and adjusted for different error variation for each treatment group.|||0.52|0.33|<0.001
72578717|NCT01644617|144684755|SUPERIORITY_OR_OTHER||Difference in LSM: D. farinae|0.52|||<|0.001|TWO_SIDED|95.0|0.41|0.64|||ANOVA||Analysis by ANOVA with treatment as fixed effect and adjusted for different error variation for each treatment group.|||0.64|0.41|<0.001
72578718|NCT01644617|144684755|SUPERIORITY_OR_OTHER||Difference in LSM: D. farinae|0.39|||<|0.001|TWO_SIDED|95.0|0.3|0.48|||ANOVA||Analysis by ANOVA with treatment as fixed effect and adjusted for different error variation for each treatment group.|||0.48|0.30|<0.001
72578719|NCT01644617|144684756|SUPERIORITY_OR_OTHER||Difference in LSM: D. pteronyssinus|0.23|||<|0.001|TWO_SIDED|95.0|0.13|0.33|||ANOVA||Analysis by ANOVA with treatment as fixed effect and adjusted for different error variation for each treatment group.|||0.33|0.13|<0.001
72578720|NCT01644617|144684756|SUPERIORITY_OR_OTHER||Difference in LSM: D. pteronyssinus|0.19|||<|0.001|TWO_SIDED|95.0|0.12|0.25|||ANOVA||Analysis by ANOVA with treatment as fixed effect and adjusted for different error variation for each treatment group.|||0.25|0.12|<0.001
72578721|NCT01644617|144684756|SUPERIORITY_OR_OTHER||Difference in LSM: D. farinae|0.32|||<|0.001|TWO_SIDED|95.0|0.23|0.42|||ANOVA||Analysis by ANOVA with treatment as fixed effect and adjusted for different error variation for each treatment group.|||0.42|0.23|<0.001
72578722|NCT01644617|144684756|SUPERIORITY_OR_OTHER||Difference in LSM: D. farinae|0.25|||<|0.001|TWO_SIDED|95.0|0.16|0.33|||ANOVA||Analysis by ANOVA with treatment as fixed effect and adjusted for different error variation for each treatment group.|||0.33|0.16|<0.001
72578723|NCT01644617|144684757|SUPERIORITY_OR_OTHER||Difference in Percentage Versus Placebo|12.4||||||95.0|-3.6|28.9|||||Analysis based on the Miettinen and Nurminen method|||28.9|-3.6|
72578724|NCT01644617|144684757|SUPERIORITY_OR_OTHER||Difference in Percentage Versus Placebo|9.8|||||TWO_SIDED|95.0|-7.0|26.6|||||Analysis based on the Miettinen and Nurminen method|||26.6|-7.0|
72578725|NCT01644617|144684758|SUPERIORITY_OR_OTHER||Difference in Percentage Versus Placebo|-7.5|||||TWO_SIDED|95.0|-22.6|6.7|||||Analysis based on the Miettinen and Nurminen method|||6.7|-22.6|
72578726|NCT01644617|144684758|SUPERIORITY_OR_OTHER||Difference in Percentage Versus Placebo|-14.6|||||TWO_SIDED|95.0|-28.5|-5.4|||||Analysis based on the Miettinen and Nurminen method|||-5.4|-28.5|
72578727|NCT02075515|144684759|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Superiority Criterion: The two-sided 95 % CI of the GMC ratio between all pairs of lots are within \[0.67, 1.5\]|Adjusted GMC Ratio|0.97|||||TWO_SIDED|95.0|0.86|1.09|||ANCOVA|||||1.09|0.86|
72544190|NCT01360632|144618360|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.39||||0.0139|TWO_SIDED|95.0|-2.5|-0.28|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis at Week 11. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.||-0.28|-2.5|0.0139
72544191|NCT01360632|144618360|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.71||||0.2097|TWO_SIDED|95.0|-1.82|0.4|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis at Week 11. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.||0.4|-1.82|0.2097
72544192|NCT01360632|144618360|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.56||||0.0099|TWO_SIDED|95.0|-2.75|-0.38|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis at Week 12. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.||-0.38|-2.75|0.0099
72578728|NCT02075515|144684759|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Superiority Criterion: The two-sided 95 % CI of the GMC ratio between all pairs of lots are within \[0.67, 1.5\]|Adjustd GMC Ratio|0.96|||||TWO_SIDED|95.0|0.85|1.08|||ANCOVA|||||1.08|0.85|
72578729|NCT02075515|144684759|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Superiority Criterion: The two-sided 95 % CI of the GMC ratio between all pairs of lots are within \[0.67, 1.5\].|Adjusted GMC ratio|0.99|||||TWO_SIDED|95.0|0.88|1.1|||ANCOVA|||||1.10|0.88|
72578730|NCT01297985|144684769|SUPERIORITY||MIXREG Estimate|1.55|STANDARD_ERROR_OF_MEAN|0.62||0.013|TWO_SIDED||||||Mixed Effects Random Regression|||"This mixed effects random regression analysis tested whether intervention participants would report larger increases than controls in self-perceived Recovery and that this effect would be maintained overtime; and that intervention participants would report greater increases in hopefulness than controls, also maintained longitudinally~This first model reports on Recovery over time."||||.013
72578731|NCT01297985|144684770|SUPERIORITY||MIXREG Estimate|0.04|STANDARD_ERROR_OF_MEAN|0.02||0.01|TWO_SIDED||||||Mixed Effects Random Regression|This analysis used Random Regression Modeling; this first model included depressive symptoms as moderator||"We tested 3 moderating variables: BSI depressive symptom, anxiety, and general symptom distress. In these three models, we hypothesized that the intervention participants with high levels of each type of symptoms would experience greater gains in empowerment over time than participants with low levels of symptoms, as well as control participants with both high and low symptom level.~This model includes depressive symptoms as the moderator (High depressive symptoms X time X study condition)"||||0.01
72578732|NCT01297985|144684770|SUPERIORITY||MIXREG Estimate|0.04|STANDARD_ERROR_OF_MEAN|0.02||0.01|TWO_SIDED||||||Mixed Effects Random Regression|This analysis used Random Regression Modeling; this second model included anxiety symptoms as moderator||"We tested 3 moderating variables: depressive symptom, anxiety, and general symptom distress. In these three models, we hypothesized that the intervention participants with high levels of each type of symptoms would experience greater gains in empowerment over time than participants with low levels of symptoms, as well as control participants with both high and low symptom level.~This model includes anxiety as the moderator (high anxiety X time X study condition)"||||0.01
72578733|NCT01297985|144684770|SUPERIORITY||MIXREG Estimate|0.03|STANDARD_ERROR_OF_MEAN|0.01||0.022|TWO_SIDED||||||Mixed Effects Random Regression|This analysis used Random Regression Modeling; this third model included the general symptom distress as moderator||"We tested 3 moderating variables: BSI depressive symptom, anxiety, and general symptom distress. In these three models, we hypothesized that the intervention participants with high levels of each type of symptoms would experience greater gains in empowerment over time than participants with low levels of symptoms, as well as control participants with both high and low symptom level.~This model includes general symptom distress as the moderator (high symptom distress X time X study condition)"||||.022
72578734|NCT01297985|144684771|SUPERIORITY||MIXREG Estimate|0.33|STANDARD_ERROR_OF_MEAN|0.012|<|0.01|TWO_SIDED||||||Mixed Effects Random Regression|||This mixed effects random regression analysis tested whether intervention participants would report larger increases than controls in Hopefulness that would be maintained longitudinally||||<.01
72578735|NCT01297985|144684772|SUPERIORITY||MIXREG Estimate|0.12|STANDARD_ERROR_OF_MEAN|0.04|<|0.01|TWO_SIDED||||||Mixed Effects Random Regression|||This analysis Mixed Effects Random Regression Modeling to test whether self-advocacy scores changed overtime by study condition status. Reported below are findings for the self-advocacy assertiveness sub scale.||||<0.01
72578736|NCT01297985|144684773|SUPERIORITY||MIXREG Estimate|0.042|STANDARD_ERROR_OF_MEAN|0.018||0.017|TWO_SIDED||||||Mixed Effects Random Regression|||||||0.017
72578737|NCT01807065|144684788|OTHER|||||||0.06|||||||Log Rank|||||||0.06
72578738|NCT05246670|144684794|SUPERIORITY||Mean Difference (Final Values)|2.21|||||TWO_SIDED|95.0|-1.33|5.74||||||||5.74|-1.33|
72544193|NCT01360632|144618360|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.29||||0.034|TWO_SIDED|95.0|-2.48|-0.1|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis at Week 12. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.||-0.1|-2.48|0.034
72578739|NCT05246670|144684794|SUPERIORITY||Mean Difference (Final Values)|0.09|||||TWO_SIDED|95.0|-5.23|5.41||||||||5.41|-5.23|
72578740|NCT05246670|144684794|SUPERIORITY||Mean Difference (Final Values)|2.11|||||TWO_SIDED|95.0|-2.87|7.09||||||||7.09|-2.87|
72411380|NCT04079933|144331124|EQUIVALENCE|Null hypothesis = Test and Control groups will have equivalent levels of percent change from baseline to end of study in S-PMA; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of percent change from baseline to end of study in S-PMA|Mean Difference (Net)|-19.0||||0.1524|TWO_SIDED|95.0|-45.1|7.12|||t-test, 2 sided||"Difference in Least Square means (Test - Control) using Mixed Effects Repeated Measures Model 1:~Percent Change from baseline = study group + visit + study group\*visit + subject + random error, fitted with unstructured covariance matrix."|Null hypothesis = Test and Control groups will have equivalent levels of percent change from baseline to end of study in S-PMA; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of percent change from baseline to end of study in S-PMA||7.12|-45.1|0.1524
72411381|NCT04079933|144331124|EQUIVALENCE|Null hypothesis = Test and Control groups will have equivalent levels of percent change from baseline to end of study in S-PMA; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of percent change from baseline to end of study in S-PMA|Mean Difference (Net)|-12.1||||0.4014|TWO_SIDED|95.0|-40.4|16.3|||t-test, 2 sided||"Difference in LS means (Test - Control) using Mixed Effects Repeated Measures Model 2:~%Change from baseline = study group +visit +study group\*visit +CPD +Sex +Race +BMI +Age +subject +random error, fitted with unstructured covariance matrix."|Null hypothesis = Test and Control groups will have equivalent levels of percent change from baseline to end of study in S-PMA; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of percent change from baseline to end of study in S-PMA||16.3|-40.4|0.4014
72411382|NCT04079933|144331125|EQUIVALENCE|Null hypothesis = Test and Control groups will have equivalent levels of change from baseline in carboxyhemoglobin; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of change from baseline in carboxyhemoglobin|Mean Difference (Net)|-0.507||||0.0241|TWO_SIDED|95.0|-0.946|-0.0674|||t-test, 2 sided||"Difference in LS means (Test - Control) using Mixed Effects Repeated Measures Model 1:~Change from baseline = study group + visit + study group\*visit + subject +random error, fitted with unstructured covariance matrix"|Null hypothesis = Test and Control groups will have equivalent levels of change from baseline in carboxyhemoglobin; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of change from baseline in carboxyhemoglobin||-0.0674|-0.946|0.0241
72411383|NCT04079933|144331125|EQUIVALENCE|Null hypothesis = Test and Control groups will have equivalent levels of change from baseline in carboxyhemoglobin; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of change from baseline in carboxyhemoglobin|Mean Difference (Net)|-0.367||||0.1292|TWO_SIDED|95.0|-0.843|0.108|||t-test, 2 sided||"Difference in LS means (Test - Control) using Mixed Effects Repeated Measures Model 2:~Change from baseline= study group + visit + study group\*visit + CPD + Sex + Race + BMI + Age + subject + random error, fitted with unstructured covariance matrix"|Null hypothesis = Test and Control groups will have equivalent levels of change from baseline in carboxyhemoglobin; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of change from baseline in carboxyhemoglobin||0.108|-0.843|0.1292
72411384|NCT04079933|144331126|EQUIVALENCE|Null hypothesis = Test and Control groups will have equivalent levels of percent change from baseline to end of study in carboxyhemoglobin; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of percent change from baseline to end of study in carboxyhemoglobin|Mean Difference (Net)|-10.0||||0.0333|TWO_SIDED|95.0|-19.2|-0.803|||t-test, 2 sided||"Difference in Least Square means (Test - Control) using Mixed Effects Repeated Measures Model 1:~Percent Change from baseline = study group + visit + study group\*visit + subject + random error, fitted with unstructured covariance matrix."|Null hypothesis = Test and Control groups will have equivalent levels of percent change from baseline to end of study in carboxyhemoglobin; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of percent change from baseline to end of study in carboxyhemoglobin||-0.803|-19.2|0.0333
72411385|NCT04079933|144331126|EQUIVALENCE|Null hypothesis = Test and Control groups will have equivalent levels of percent change from baseline to end of study in carboxyhemoglobin; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of percent change from baseline to end of study in carboxyhemoglobin|Mean Difference (Net)|-6.76||||0.1767|TWO_SIDED|95.0|-16.6|3.08|||t-test, 2 sided||"Difference in LS means (Test - Control) using Mixed Effects Repeated Measures Model 2:~%Change from baseline = study group +visit +study group\*visit +CPD +Sex +Race +BMI +Age +subject +random error, fitted with unstructured covariance matrix."|Null hypothesis = Test and Control groups will have equivalent levels of percent change from baseline to end of study in carboxyhemoglobin; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of percent change from baseline to end of study in carboxyhemoglobin||3.08|-16.6|0.1767
72544194|NCT01360632|144618360|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.53||||0.0177|TWO_SIDED|95.0|-2.8|-0.27|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis at Week 13. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.||-0.27|-2.8|0.0177
72544195|NCT01360632|144618360|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.71||||0.0085|TWO_SIDED|95.0|-2.98|-0.44|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis at Week 13. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.||-0.44|-2.98|0.0085
72578741|NCT00911300|144684830|SUPERIORITY_OR_OTHER||Percentage of participants|0.5||||1|TWO_SIDED|95.0|-2.0|3.1|||Fisher Exact||The estimated value is the absolute percent difference between Fondaparinux and UFH/VKA.|||3.1|-2.0|1.000
72421530|NCT01181726|144354213|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|104.66|||||TWO_SIDED|90.0|94.22|116.25|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||116.25|94.22|
72544196|NCT01360632|144618361|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.92||||0.0286|TWO_SIDED|95.0|-1.74|-0.1|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 1 at Week 9. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.||-0.1|-1.74|0.0286
72544197|NCT01360632|144618361|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.42||||0.3173|TWO_SIDED|95.0|-1.24|0.4|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 2 at Week 9. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.||0.4|-1.24|0.3173
72544198|NCT01360632|144618361|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.17||||0.0313|TWO_SIDED|95.0|-2.23|-0.11|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate||Statistical analysis 1 at Week 10. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.||-0.11|-2.23|0.0313
72544199|NCT01360632|144618361|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.97||||0.0732|TWO_SIDED|95.0|-2.04|0.09|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 2 at Week 10. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.||0.09|-2.04|0.0732
72578742|NCT05124691|144684845|SUPERIORITY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||pairwise comparisons of cure rates within the three study groups, considering an overall significance level of 0.05. To account for multiple testing, a Bonferroni correction was applied, resulting in an adjusted significance level of 0.0167||||<0.0001
72578743|NCT05124691|144684845|SUPERIORITY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||Pairwise comparisons of cure rates within the three study groups, considering an overall significance level of 0.05. To account for multiple testing, a Bonferroni correction was applied, resulting in an adjusted significance level of 0.0167||||<0.0001
72578744|NCT05124691|144684845|SUPERIORITY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||Pairwise comparisons of cure rates within the three study groups, considering an overall significance level of 0.05. To account for multiple testing, a Bonferroni correction was applied, resulting in an adjusted significance level of 0.0167||||<0.0001
72578745|NCT05124691|144684848|SUPERIORITY||||||<|0.0001|||||||Mantel Haenszel|||Pairwise comparisons of cure rates were conducted between Albendazole and FDCx3, as well as FDCx1 and FDCx3, but not between Albendazole and FDCx1, since both contain the same dose regimen of the active drug. An overall significance level of 0.05 was considered, and to account for multiple testing, a Bonferroni correction was applied.||||<0.0001
72578746|NCT05124691|144684848|SUPERIORITY||||||=|0.0007|||||||Cochran-Mantel-Haenszel|||Pairwise comparisons of cure rates were conducted between Albendazole and FDCx3, as well as FDCx1 and FDCx3, but not between Albendazole and FDCx1, since both contain the same dose regimen of the active drug. An overall significance level of 0.05 was considered, and to account for multiple testing, a Bonferroni correction was applied.||||=0.0007
72578747|NCT05124691|144684851|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||< 0.001
72578748|NCT05124691|144684851|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
72578749|NCT05124691|144684851|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
72578750|NCT04345913|144684865|OTHER|This test is used to compare the survival distributions of different groups in a survival analysis. It's a nonparametric test.||||||0.5259|||||||Log Rank|||||||0.5259
72578751|NCT04345913|144684870|OTHER|This test is used to compare the survival distributions of different groups in a survival analysis. It's a nonparametric test.||||||0.706|||||||Log Rank|||||||0.7060
72329485|NCT03037476|144184393|OTHER|General Linear Model|Slope|-0.0092||||0.871|TWO_SIDED|95.0|-0.1202|0.1018|||Mixed Models Analysis|General Linear Model||Change in cumulative grade point average at 12 month follow up||0.1018|-0.1202|0.871
72544200|NCT01360632|144618361|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.36||||0.0206|TWO_SIDED|95.0|-2.51|-0.21|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 1 at Week 11. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.||-0.21|-2.51|0.0206
72578752|NCT02211417|144684902|SUPERIORITY|||||||0.057|||||||Cochran-Mantel-Haenszel|||||||0.057
72578753|NCT00490841|144684918|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||1-sided exact binomial test|||"objective is to demonstrate the binary restenosis rate at 9 months is \< 28.6% OPC. Assumptions for the primary endpoint analysis:~* H0: Restenosis Rate ≥ 28.6%~* HA: Restenosis Rate \< 28.6%~* Assumed binary restenosis rate = 20%~* Power = 80%~* One-sided type I error = 5%~With the above assumptions, 161 samples would be required. To account for approximately 20% lost to follow-up rate, 202 subjects will be enrolled in the study. The sample size calculation was performed using PASS 2005."||||< 0.0001
72578754|NCT02503787|144684981|SUPERIORITY||||||<|0.01|||||||t-test, 2 sided|||A negative value for change in pain represents a reduction (improvement) of the subject's pain score. The null hypothesis was that the mean change from baseline to 3 months equals 0. The sample provided over 90% power, with two-sided significance level of 0.05, to detect a change of 2 points.||||<0.01
72578755|NCT00174954|144685000|SUPERIORITY_OR_OTHER|||||||0.785||95.0||||The a priori threshold for statistical significance was 0.05.|paired t-test|||||||0.785
72578756|NCT00174954|144685001|SUPERIORITY_OR_OTHER|||||||0.02||95.0||||The a priori threshold for statistical significance is 0.05.|paired t-test|||||||0.020
72578757|NCT00839254|144685002|SUPERIORITY|VE (defined as 1 minus Relative Risk (RR)) was calculated by comparing numbers of culture-confirmed IPD. The number of subjects with IPD in each cluster was compared between groups (10PN3+1 vs Control). This comparison was done using a negative binomial log-linear model with correction for dispersion group- and cluster-related effect.|VE (1-RR)|100.0|||<|0.0001|TWO_SIDED|95.0|82.8|100.0||P-value was calculated using a classical log linear Poisson regression with strata, without taking into account the multiplicity of the endpoints.|Regression, Linear|||Analysis aimed at providing an estimate of vaccine effectiveness (VE) at preventing culture-confirmed IPD by comparing PYARs between groups taking into account the following parameters: T, n, n+ (number of clusters with at least one event culture-confirmed ID), and n/T. VE of the 10Pn vaccine in preventing culture-confirmed IPD due to the 10 vaccine serotypes was demonstrated if the 2-sided p-value calculated for the null hypothesis H0 = (vaccine-type \[VT\] IPD VE = 0%) was lower than (\<) 5%.||100|82.8|<0.0001
72578758|NCT00839254|144685003|SUPERIORITY|VE (defined as 1 minus Relative Risk (RR)) was calculated by comparing numbers of culture-confirmed IPD. The number of subjects with IPD in each cluster was compared between groups (10PN2+1 vs Control). This comparison was done using a negative binomial log-linear model with correction for dispersion group- and cluster-related effect.|VE (1-RR)|91.8|||=|0.0009|TWO_SIDED|95.0|58.3|99.6||p-value was calculated using a classical log linear Poisson regression with strata, without taking into account the multiplicity of the endpoints.|Regression, Linear|||Analysis aimed at providing an estimate of vaccine effectiveness (VE) at preventing culture-confirmed IPD by comparing PYARs between groups taking into account the following parameters: T, n, n+ (number of clusters with at least one event culture-confirmed ID), and n/T. VE of the 10Pn vaccine in preventing culture-confirmed IPD due to the 10 vaccine serotypes was demonstrated if the 2-sided p-value calculated for the null hypothesis H0 = (vaccine-type \[VT\] IPD VE = 0%) was lower than (\<) 5%.||99.6|58.3|= 0.0009
72578759|NCT02687529|144685098|EQUIVALENCE|The number of positive and negative CST001 assay results for each subject, across all sites and operators were compared. In order for a subject to have a concordant result, the same assay call must be observed for all replicates across all sites (6/6).|proportion of concordant calls|83.33|||||TWO_SIDED|95.0|72.13|91.38||||||||91.38|72.13|
72578760|NCT02374138|144685099|SUPERIORITY|||||||0.93||||||By repeated measures, p-value adjusted for age and gender|Generalized Linear Model Analysis|||At 6 Months||||0.93
72578761|NCT02374138|144685100|SUPERIORITY|||||||0.87||||||By repeated measures, p-value adjusted for age and gender|Generalized Linear Model Analysis|||At 6 month follow up||||0.87
72578762|NCT02374138|144685100|SUPERIORITY|||||||0.25||||||By repeated measures, p-value adjusted for age and gender|Generalized Linear Model Analysis|||At 12 month follow up||||0.25
72578763|NCT02374138|144685102|SUPERIORITY|||||||0.35||||||By repeated measures, p-value adjusted for age and gender|Generalized Linear Model Analysis|||ICS Use at 6 Month Follow Up||||0.35
72578764|NCT02374138|144685102|SUPERIORITY|||||||0.34||||||By repeated measures, p-value adjusted for age and gender|Generalized Linear Model Analysis|||ICS Use at 12 Month Follow Up||||0.34
72578765|NCT02374138|144685102|SUPERIORITY|||||||0.35||||||By repeated measures, p-value adjusted for age and gender|Generalized Linear Model Analysis|||LTRA Use at 6 Months||||0.35
72578766|NCT02374138|144685102|SUPERIORITY|||||||0.62||||||By repeated measures, p-value adjusted for age and gender|Generalized Linear Model Analysis|||LTRA use at 12 Month Follow Up||||0.62
72578767|NCT02374138|144685103|SUPERIORITY|||||||0.63||||||Adjusted for child age, gender, and baseline value|Generalized Linear Model Analysis|||ED visits over 6 months||||0.63
72578768|NCT02374138|144685103|SUPERIORITY|||||||0.44||||||Adjusted for child age, gender, and baseline value|Generalized Linear Model Analysis|||ED Visits between 6 and 12 Month follow up||||0.44
72578769|NCT02374138|144685104|SUPERIORITY|||||||0.98||||||Adjusted for child age, gender, and baseline value|Generalized Linear Model Analysis|||Courses of systemic steroids over 6 months||||0.98
72578770|NCT02374138|144685104|SUPERIORITY|||||||0.48||||||Adjusted for child age, gender, and baseline value|Generalized Linear Model Analysis|||Courses of systemic steroids between 6m and 12m FU||||0.48
72578771|NCT02374138|144685105|SUPERIORITY|||||||0.32||||||By repeated measures, p-value adjusted for age and gender|Generalized Linear Model Analysis|||At 6 Month Follow Up||||0.32
72578772|NCT02374138|144685105|SUPERIORITY|||||||0.06||||||By repeated measures, p-value adjusted for age and gender|Generalized Linear Model Analysis|||At 12 Month Follow Up||||0.06
72578773|NCT02374138|144685106|SUPERIORITY|||||||0.32||||||By repeated measures, p-value adjusted for age and gender|Generalized Linear Model Analysis|||At 6 Month follow up||||0.32
72578774|NCT02374138|144685106|SUPERIORITY|||||||0.44||||||By repeated measures, p-value adjusted for age and gender|Generalized Linear Model Analysis|||At 12 month follow up||||0.44
72578775|NCT02374138|144685107|SUPERIORITY|||||||0.7||||||Repeated measures, p-value adjusted for age and gender|Generalized Linear Model Analysis|||At 6 Month Follow Up||||0.70
72578776|NCT02374138|144685107|SUPERIORITY|||||||0.8||||||Repeated measures, p-value adjusted for age and gender|Generalized Linear Model Analysis|||At 12 Month Follow Up||||0.80
72578777|NCT02374138|144685108|SUPERIORITY|||||||0.53||||||Repeated measures, p-value adjusted for age and gender|Generalized Linear Model Analysis|||6 Month Follow Up||||0.53
72578778|NCT02374138|144685108|SUPERIORITY|||||||0.77||||||Repeated measures, p-value adjusted for age and gender|Generalized Linear Model Analysis|||12 Month Follow up||||0.77
72578779|NCT02374138|144685109|SUPERIORITY|||||||0.53||||||Repeated measures, p-value adjusted for age and gender|Generalized Linear Model Analysis|||Quality of Life at 6 Month Follow up||||0.53
72544201|NCT01360632|144618361|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.91||||0.1233|TWO_SIDED|95.0|-2.06|0.25|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 2 at Week 11. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.||0.25|-2.06|0.1233
72544202|NCT01360632|144618361|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.61||||0.0097|TWO_SIDED|95.0|-2.84|-0.39|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 1 at Week 12. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.||-0.39|-2.84|0.0097
72544203|NCT01360632|144618361|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.63||||0.0092|TWO_SIDED|95.0|-2.86|-0.41|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 2 at Week 12. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.||-0.41|-2.86|0.0092
72578780|NCT02374138|144685109|SUPERIORITY|||||||0.57||||||Repeated measures, p-value adjusted for age and gender|Generalized Linear Model Analysis|||Quality of Life at 12 Month Follow up||||0.57
72329486|NCT03037476|144184393|OTHER|General Linear Model|Slope|0.003||||0.957|TWO_SIDED|95.0|-0.1063|0.1124|||Mixed Models Analysis|Poisson regression||Change in last term GPA at 6 month follow-up||0.1124|-0.1063|0.957
72578781|NCT02374138|144685110|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.0
72544204|NCT01360632|144618361|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.63||||0.0139|TWO_SIDED|95.0|-2.94|-0.33|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 1 at Week 13. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.||-0.33|-2.94|0.0139
72544205|NCT01360632|144618361|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.12||||0.0015|TWO_SIDED|95.0|-3.42|-0.81|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 2 at Week 13. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.||-0.81|-3.42|0.0015
72544206|NCT01360632|144618362|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.55||||0.0008|TWO_SIDED|95.0|-0.87|-0.23||MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.|Mixed Models Analysis|||Statistical analysis 1 at Week 11. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.||-0.23|-0.87|0.0008
72544207|NCT01360632|144618362|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.09||||0.5792|TWO_SIDED|95.0|-0.41|0.23||MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.|Mixed Models Analysis|||Statistical analysis 2 at Week 11. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B||0.23|-0.41|0.5792
72544208|NCT01360632|144618362|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.49||||0.0091|TWO_SIDED|95.0|-0.87|-0.12|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 1 at Week 14. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.||-0.12|-0.87|0.0091
72544209|NCT01360632|144618362|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.37||||0.0474|TWO_SIDED|95.0|-0.73|0.0|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 1 at Week 14. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.||0|-0.73|0.0474
72544210|NCT01360632|144618363|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.58||||0.0015|TWO_SIDED|95.0|-0.94|-0.22||MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.|Mixed Models Analysis|||Statistical analysis 1 at Week 11. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.||-0.22|-0.94|0.0015
72544211|NCT01360632|144618363|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.21||||0.2627|TWO_SIDED|95.0|-0.56|0.15||MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate|Mixed Models Analysis|||Statistical analysis 2 at Week 11. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.||0.15|-0.56|0.2627
72544212|NCT01360632|144618363|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.49||||0.0158|TWO_SIDED|95.0|-0.89|-0.09|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 1 at Week 14. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3||-0.09|-0.89|0.0158
72544213|NCT01360632|144618363|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.48||||0.0191|TWO_SIDED|95.0|-0.88|-0.08|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 2 at Week 14. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.||-0.08|-0.88|0.0191
72544214|NCT01360632|144618364|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.45||||0.0377|TWO_SIDED|95.0|-0.88|-0.03|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||For Item: Work/School: Week 11||-0.03|-0.88|0.0377
72544215|NCT01360632|144618364|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.43||||0.0741|TWO_SIDED|95.0|-0.91|0.04||MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.|Mixed Models Analysis||-0.43|For Item: Work/School: Week 14||0.04|-0.91|0.0741
72544216|NCT01360632|144618364|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.37||||0.0966|TWO_SIDED|95.0|-0.07|0.81||MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.|Mixed Models Analysis|||For Item: Work/School: Week 11||0.81|-0.07|0.0966
72544217|NCT01360632|144618364|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.18||||0.4774|TWO_SIDED|95.0|-0.66|0.31|||Mixed Models Analysis|||For Item: Work/School: Week 14||0.31|-0.66|0.4774
72544218|NCT01360632|144618364|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.41||||0.0263|TWO_SIDED|95.0|-0.76|-0.05||MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.|Mixed Models Analysis|||Social life: Week 11||-0.05|-0.76|0.0263
72544219|NCT01360632|144618364|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.48||||0.0214|TWO_SIDED|95.0|-0.89|-0.07|||Mixed Models Analysis|||Social life: Week 14||-0.07|-0.89|0.0214
72544220|NCT01360632|144618364|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.04||||0.8281|TWO_SIDED|95.0|-0.4|0.32||MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.|Mixed Models Analysis|||Social life: Week 11||0.32|-0.40|0.8281
72544221|NCT01360632|144618364|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.4||||0.054|TWO_SIDED|95.0|-0.8|0.01|||Mixed Models Analysis|||Social life: Week 14||0.01|-0.80|0.0540
72544222|NCT01360632|144618364|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.63||||0.0008|TWO_SIDED|95.0|-0.99|-0.26||MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.|Mixed Models Analysis|||Family life: Week 11||-0.26|-0.99|0.0008
72544223|NCT01360632|144618364|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.55||||0.0093|TWO_SIDED|95.0|-0.97|-0.14|||Mixed Models Analysis|||Family life: Week 14||-0.14|-0.97|0.0093
72544224|NCT01360632|144618364|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.23||||0.2182|TWO_SIDED|95.0|-0.59|0.14|||Mixed Models Analysis|||Family life: Week 11||0.14|-0.59|0.2182
72544225|NCT01360632|144618364|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.48||||0.0256|TWO_SIDED|95.0|-0.9|-0.06||MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.|Mixed Models Analysis|||Family life: Week 14||-0.06|-0.90|0.0256
72544226|NCT01360632|144618365|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.53||||0.0341|TWO_SIDED|95.0|-1.01|-0.04||MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.|Mixed Models Analysis|||Work/school: Week 11||-0.04|-1.01|0.0341
72544227|NCT01360632|144618365|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.46||||0.0816|TWO_SIDED|95.0|-0.99|0.06||MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.|Mixed Models Analysis|||School/work: Week 14||0.06|-0.99|0.0816
72544228|NCT01360632|144618365|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.29||||0.2561|TWO_SIDED|95.0|-0.21|0.78||MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.|Mixed Models Analysis|||Work/school: Week 11||0.78|-0.21|0.2561
72411386|NCT04079933|144331127|EQUIVALENCE|Null hypothesis = Test and Control groups will have equivalent levels of change from baseline in exhaled carbon monoxide; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of change from baseline in exhaled carbon monoxide|Mean Difference (Net)|-1.51||||0.2961|TWO_SIDED|95.0|-4.36|1.34|||t-test, 2 sided||"Difference in LS means (Test - Control) using Mixed Effects Repeated Measures Model 1:~Change from baseline = study group + visit + study group\*visit + subject +random error, fitted with unstructured covariance matrix"|Null hypothesis = Test and Control groups will have equivalent levels of change from baseline in exhaled carbon monoxide; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of change from baseline in exhaled carbon monoxide||1.34|-4.36|0.2961
72411387|NCT04079933|144331127|EQUIVALENCE|Null hypothesis = Test and Control groups will have equivalent levels of change from baseline in exhaled carbon monoxide; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of change from baseline in exhaled carbon monoxide|Mean Difference (Net)|-1.05||||0.5015|TWO_SIDED|95.0|-4.12|2.03|||t-test, 2 sided||"Difference in LS means (Test - Control) using Mixed Effects Repeated Measures Model 2:~Change from baseline= study group + visit + study group\*visit + CPD + Sex + Race + BMI + Age + subject + random error, fitted with unstructured covariance matrix"|Null hypothesis = Test and Control groups will have equivalent levels of change from baseline in exhaled carbon monoxide; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of change from baseline in exhaled carbon monoxide||2.03|-4.12|0.5015
72411388|NCT04079933|144331128|EQUIVALENCE|Null hypothesis = Test and Control groups will have equivalent levels of percent change from baseline to end of study in exhaled carbon monoxide; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of percent change from baseline to end of study in exhaled carbon monoxide|Mean Difference (Net)|-12.1||||0.2048|TWO_SIDED|95.0|-30.9|6.68|||t-test, 2 sided||"Difference in Least Square means (Test - Control) using Mixed Effects Repeated Measures Model 1:~Percent Change from baseline = study group + visit + study group\*visit + subject + random error, fitted with unstructured covariance matrix."|Null hypothesis = Test and Control groups will have equivalent levels of percent change from baseline to end of study in exhaled carbon monoxide; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of percent change from baseline to end of study in exhaled carbon monoxide||6.68|-30.9|0.2048
72411389|NCT04079933|144331128|EQUIVALENCE|Null hypothesis = Test and Control groups will have equivalent levels of percent change from baseline to control in exhaled carbon monoxide; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of percent change from baseline to control in exhaled carbon monoxide|Mean Difference (Net)|-7.32||||0.4731|TWO_SIDED|95.0|-27.4|12.8|||t-test, 2 sided||"Difference in LS means (Test - Control) using Mixed Effects Repeated Measures Model 2:~%Change from baseline = study group +visit +study group\*visit +CPD +Sex +Race +BMI +Age +subject +random error, fitted with unstructured covariance matrix."|Null hypothesis = Test and Control groups will have equivalent levels of percent change from baseline to control in exhaled carbon monoxide; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of percent change from baseline to control in exhaled carbon monoxide||12.8|-27.4|0.4731
72411390|NCT04079933|144331129|EQUIVALENCE|Null hypothesis = Test and Control groups will have equivalent levels of change from baseline in cigarettes smoked per day; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of change from baseline in cigarettes smoked per day|Mean Difference (Net)|-3.86|||<|0.0001|TWO_SIDED|95.0|-5.25|-2.47|||t-test, 2 sided||"Difference in LS means (Test - Control) using Mixed Effects Repeated Measures Model 1:~Change from baseline = study group + visit + study group\*visit + subject +random error, fitted with unstructured covariance matrix"|Null hypothesis = Test and Control groups will have equivalent levels of change from baseline in cigarettes smoked per day; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of change from baseline in cigarettes smoked per day||-2.47|-5.25|<0.0001
72544229|NCT01360632|144618365|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.29||||0.2952|TWO_SIDED|95.0|-0.82|0.25||MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.|Mixed Models Analysis|||Work/school: Week 14||0.25|-0.82|0.2952
72544230|NCT01360632|144618365|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.43||||0.0331|TWO_SIDED|95.0|-0.82|-0.03||MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.|Mixed Models Analysis|||Social life: Week 11||-0.03|-0.82|0.0331
72544231|NCT01360632|144618365|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.47||||0.0352|TWO_SIDED|95.0|-0.9|-0.03|||Mixed Models Analysis|||Social life: Week 14||-0.03|-0.90|0.0352
72544232|NCT01360632|144618365|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.14||||0.486|TWO_SIDED|95.0|-0.54|0.25||MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.|Mixed Models Analysis|||Social life: Week 11||0.25|-0.54|0.4860
72544233|NCT01360632|144618365|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.49||||0.0282|TWO_SIDED|95.0|-0.93|-0.05||MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.|Mixed Models Analysis|||Social life: Week 14||-0.05|-0.93|0.0282
72544234|NCT01360632|144618365|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.62||||0.0016|TWO_SIDED|95.0|-1.01|-0.24||MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.|Mixed Models Analysis|||Family life: Week 11||-0.24|-1.01|0.0016
72544235|NCT01360632|144618365|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.51||||0.0186|TWO_SIDED|95.0|-0.94|-0.09|||Mixed Models Analysis|||Family life: Week 14||-0.09|-0.94|0.0186
72544236|NCT01360632|144618365|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.35||||0.0824|TWO_SIDED|95.0|-0.73|0.04||MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.|Mixed Models Analysis|||Family life: Week 11||0.04|-0.73|0.0824
72544237|NCT01360632|144618365|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.59||||0.0077|TWO_SIDED|95.0|-1.02|-0.16||MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.|Mixed Models Analysis|||Family life: Week 14||-0.16|-1.02|0.0077
72544238|NCT01360632|144618366|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.09||||0.0436|TWO_SIDED|95.0|-0.18|0.0|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 1 at Week 9. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.||0|-0.18|0.0436
72544239|NCT01360632|144618366|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.06||||-0.06|TWO_SIDED|95.0|-0.15|0.03|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 2 at Week 9. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.||0.03|-0.15|-0.06
72544240|NCT01360632|144618366|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.21||||0.0012|TWO_SIDED|95.0|-0.34|-0.08|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 1 at Week 10. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.||-0.08|-0.34|0.0012
72544241|NCT01360632|144618366|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.14||||0.0266|TWO_SIDED|95.0|-0.27|-0.02|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 2 at Week 10. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.||-0.02|-0.27|0.0266
72544242|NCT01360632|144618366|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2||||0.0034|TWO_SIDED|95.0|-0.33|-0.07|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 1 at Week 11. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.||-0.07|-0.33|0.0034
72544243|NCT01360632|144618366|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.07||||0.3053|TWO_SIDED|95.0|-0.2|0.06|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 2 at Week 11. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.||0.06|-0.2|0.3053
72544244|NCT01360632|144618366|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.15||||0.0541|TWO_SIDED|95.0|-0.29|0.0|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 1 at Week 12. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.||0|-0.29|0.0541
72544245|NCT01360632|144618366|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.13||||0.0912|TWO_SIDED|95.0|-0.28|0.02|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 2 at Week 12. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.||0.02|-0.28|0.0912
72578782|NCT02374138|144685113|SUPERIORITY|||||||0.58||||||Repeated measures, p-value adjusted for age and gender|Generalized Linear Model Analysis|||Score on Brief COPE at 12 Months||||0.58
72329487|NCT03037476|144184393|OTHER|General Linear Model|Slope|0.0006||||0.992|TWO_SIDED|95.0|-0.1098|0.1109|||Mixed Models Analysis|Poisson regression||Change in last term GPA at 12 month follow-up||0.1109|-0.1098|0.992
72421531|NCT01181726|144354214|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|97.4|||||TWO_SIDED|90.0|93.91|101.02|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||101.02|93.91|
72578783|NCT02374138|144685115|SUPERIORITY|||||||0.46||||||Repeated measures, p-value adjusted for age and gender|Generalized Linear Model Analysis|||Score on LOT-R at 6 Month Follow Up||||0.46
72578784|NCT02374138|144685115|SUPERIORITY|||||||0.62||||||Repeated measures, p-value adjusted for age and gender|Generalized Linear Model Analysis|||Score on LOT-R at 12 Month Follow Up||||0.62
72578785|NCT02374138|144685117|SUPERIORITY|By repeated measures, p-value adjusted for age and gender||||||0.35|||||||Generalized Linear Model Analysis|||||||0.35
72578786|NCT02374138|144685118|SUPERIORITY|Daytime asthma symptoms in prior 14d at 6-month follow up||||||0.54|||||||Generalized Linear Model Analysis|By repeated measures, p-value adjusted for age and gender||||||0.54
72578787|NCT02374138|144685118|SUPERIORITY|Daytime Asthma Symptoms at 12 month follow up||||||0.11|||||||Generalized Linear Model Analysis|By repeated measures, p-value adjusted for age and gender||||||0.11
72578788|NCT02374138|144685118|SUPERIORITY|Days of Activity Limitations at 6 month follow up||||||0.82|||||||Generalized Linear Model Analysis|By repeated measures, p-value adjusted for age and gender||||||0.82
72578789|NCT02374138|144685118|SUPERIORITY|Days of Activity Limitations at 12 month follow up||||||0.84|||||||Generalized Linear Model Analysis|By repeated measures, p-value adjusted for age and gender||||||0.84
72578790|NCT02374138|144685118|SUPERIORITY|Days of Quick Relief Medicine Use at 6 month follow up||||||0.7|||||||Generalized Linear Model Analysis|By repeated measures, p-value adjusted for age and gender||||||0.70
72578791|NCT02374138|144685118|SUPERIORITY|Days of Quick Relief Medicine Use at 12 month follow up||||||0.58|||||||Generalized Linear Model Analysis|By repeated measures, p-value adjusted for age and gender||||||0.58
72578792|NCT02374138|144685119|OTHER|Univariate test||||||0.2|||||||Chi-squared|||Parent education||||0.20
72578793|NCT02374138|144685120|SUPERIORITY|||||||0.91||||||Repeated measures, p-value adjusted for age and gender|Generalized Linear Model Analysis|||ETS exposure at 6 Month Follow Up||||0.91
72578794|NCT02374138|144685120|SUPERIORITY|||||||0.98||||||Repeated measures, p-value adjusted for age and gender|Generalized Linear Model Analysis|||ETS Exposure at 12 Month Follow up||||0.98
72578795|NCT02374138|144685121|OTHER|Univariate test||||||0.94|||||||Chi-squared|||||||0.94
72578796|NCT02374138|144685122|SUPERIORITY|||||||0.02||||||p-value adjusted for age and gender|Generalized Linear Model Analysis|||Parent use of mental health resources at 6 Months||||0.02
72578797|NCT02374138|144685122|SUPERIORITY|||||||0.85||||||p-value adjusted for age and gender|Generalized Linear Model Analysis|||Parent use of mental health resources at 12 Months||||0.85
72578798|NCT02374138|144685123|OTHER|Univariate test||||||0.9|||||||Wilcoxon (Mann-Whitney)|||||||0.90
72578799|NCT03736031|144685181|SUPERIORITY|||||||0.09|||||||two-sample independent t-test|An alpha of 0.05 was used.||||||0.09
72578800|NCT03736031|144685182|SUPERIORITY|||||||0.81|||||||two-sample independent t-test|An alpha of 0.05 was used.||||||0.81
72578801|NCT03736031|144685183|SUPERIORITY|||||||0.33|||||||t-test, 2 sided|||||||0.33
72578802|NCT03736031|144685184|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.0
72578803|NCT02555254|144685203|SUPERIORITY|||||||0.55|||||||Wilcoxon's rank test|||||||0.55
72578804|NCT06075277|144685211|OTHER||Ratios of adjusted geometric means [%]|126.64|||||TWO_SIDED|90.0|112.09|143.08|||||Ratio calculated as test/reference\*100. Intra-individual Geometric coefficient of variation \[%\] = 19.8|Relative bioavailability of Zongertinib administered in fed state (Test) compared with Zongertinib administered in fasted state (Reference) was estimated by the ratios of the gMeans (Test/Reference). Their corresponding 2-sided 90% confidence intervals (CIs) were provided. This method corresponds to 2 one-sided t-test procedures, each at the 5% significance level.||143.08|112.09|
72578805|NCT06075277|144685212|OTHER||Ratios of adjusted geometric means [%]|126.12|||||TWO_SIDED|90.0|106.34|149.58|||||Ratio calculated as test/reference\*100. Intra-individual Geometric coefficient of variation \[%\] = 27.9.|Relative bioavailability of Zongertinib administered in fed state (Test) compared with Zongertinib administered in fasted state (Reference) was estimated by the ratios of the gMeans (Test/Reference). Their corresponding 2-sided 90% confidence intervals (CIs) were provided. This method corresponds to 2 one-sided t-test procedures, each at the 5% significance level.||149.58|106.34|
72544246|NCT01360632|144618366|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.12||||0.1553|TWO_SIDED|95.0|-0.28|0.04|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 1 at Week 13. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.||0.04|-0.28|0.1553
72544247|NCT01360632|144618366|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.11||||0.1855|TWO_SIDED|95.0|-0.27|0.05|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 2 at Week 13. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.||0.05|-0.27|0.1855
72544248|NCT01360632|144618366|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.11||||0.2015|TWO_SIDED|95.0|-0.28|0.06|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 1 at Week 14. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.||0.06|-0.28|0.2015
72544249|NCT01360632|144618366|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.15||||0.0852|TWO_SIDED|95.0|-0.32|0.02|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 2 at Week 14. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.||0.02|-0.32|0.0852
72544250|NCT01360632|144618367|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.08||||0.0817|TWO_SIDED|95.0|-0.17|0.01|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 1 at Week 9. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.||0.01|-0.17|0.0817
72544251|NCT01360632|144618367|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.07||||0.1406|TWO_SIDED|95.0|-0.16|0.02|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 2 at Week 9. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.||0.02|-0.16|0.1406
72544252|NCT01360632|144618367|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.17||||0.011|TWO_SIDED|95.0|-0.29|-0.04|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 1 at Week 10. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.||-0.04|-0.29|0.011
72544253|NCT01360632|144618367|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.14||||0.0287|TWO_SIDED|95.0|-0.27|-0.02|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 2 at Week 10. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.||-0.02|-0.27|0.0287
72544254|NCT01360632|144618367|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.19||||0.0071|TWO_SIDED|95.0|-0.32|-0.05|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 1 at Week 11. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.||-0.05|-0.32|0.0071
72544255|NCT01360632|144618367|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.08||||0.2503|TWO_SIDED|95.0|-0.22|-0.06|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 2 at Week 11. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.||-0.06|-0.22|0.2503
72544256|NCT01360632|144618367|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.15||||0.0539|TWO_SIDED|95.0|-0.3|0.0|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 1 at Week 12. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.||0|-0.3|0.0539
72578806|NCT06075277|144685213|OTHER||Ratios of adjusted geometric means [%]|126.04|||||TWO_SIDED|90.0|111.7|142.21|||||Ratio calculated as test/reference\*100. Intra-individual Geometric coefficient of variation \[%\] = 19.6.|Relative bioavailability of Zongertinib administered in fed state (Test) compared with Zongertinib administered in fasted state (Reference) was estimated by the ratios of the gMeans (Test/Reference). Their corresponding 2-sided 90% confidence intervals (CIs) were provided. This method corresponds to 2 one-sided t-test procedures, each at the 5% significance level.||142.21|111.70|
72578807|NCT03975491|144685216|SUPERIORITY||Mean Difference (Net)|20.9||||0.32|TWO_SIDED|95.0|-17.1|76.2|||Mixed Models Analysis||From a model that included the baseline value of the dependent variable and sex (randomization stratification factor) as covariates.|||76.2|-17.1|0.32
72578808|NCT03975491|144685217|SUPERIORITY||Mean Difference (Net)|11.4||||0.25|TWO_SIDED|95.0|-7.5|34.0|||Mixed Models Analysis||From a model that included the baseline value of the dependent variable and sex (randomization stratification factor) as covariates.|||34.0|-7.5|0.25
72578809|NCT03975491|144685218|SUPERIORITY||Mean Difference (Net)|-3.6||||0.52|TWO_SIDED|95.0|-13.7|7.7|||Mixed Models Analysis||From a model that included the baseline value of the dependent variable and sex (randomization stratification factor) as covariates.|||7.7|-13.7|0.52
72578810|NCT03975491|144685219|SUPERIORITY||Mean Difference (Net)|0.59||||0.21|TWO_SIDED|95.0|-0.33|1.51|||Mixed Models Analysis||From a model that included the baseline value of the dependent variable and sex (randomization stratification factor) as covariates.|||1.51|-0.33|0.21
72578811|NCT03975491|144685221|SUPERIORITY||Mean Difference (Net)|0.0005||||0.73|TWO_SIDED|95.0|-0.0024|0.0034|||Mixed Models Analysis||From a model that included the baseline value of the dependent variable and sex (randomization stratification factor) as covariates.|||0.0034|-0.0024|0.73
72578812|NCT02260570|144685224|SUPERIORITY||F value|24.1|||<|0.0001|TWO_SIDED|||||This p-value is adjusted for multiple comparisons.|ANOVA|F(1,1,60) = 24.1, p \< 0.0001, adjusted r\^2 = 0.275||||||<0.0001
72578813|NCT02260570|144685225|SUPERIORITY||F value|6.23||||0.0184|TWO_SIDED|||||This p-value is adjusted for multiple comparisons.|ANOVA|F(1,30) = 6.23, p = 0.0184, adjusted r\^2 = 0.144||||||0.0184
72578814|NCT05026177|144685226|SUPERIORITY||Mean Difference (Final Values)|0.45||||0.5335|TWO_SIDED|95.0|-0.96|1.86|||Mixed Models Analysis|||||1.86|-0.96|0.5335
72578815|NCT05026177|144685226|SUPERIORITY||Mean Difference (Final Values)|0.38||||0.5836|TWO_SIDED|95.0|-0.99|1.76|||Mixed Models Analysis|||||1.76|-0.99|0.5836
72578816|NCT05026177|144685227|SUPERIORITY||Mean Difference (Final Values)|-1.57||||0.0763|TWO_SIDED|95.0|-3.3|0.17|||Mixed Models Analysis|||||0.17|-3.30|0.0763
72578817|NCT05026177|144685227|SUPERIORITY||Mean Difference (Final Values)|-1.24||||0.153|TWO_SIDED|95.0|-2.93|0.46|||Mixed Models Analysis|||||0.46|-2.93|0.1530
72578818|NCT04856917|144685239|SUPERIORITY||LS Mean Difference|2.9|STANDARD_ERROR_OF_MEAN|3.21||0.3757|TWO_SIDED|90.0|-2.47|8.19|||LRMM|||Least square (LS) Mean, SE, 90% CI, \& p-value was based on a linear repeated measures model (LRMM) which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline facial inflammatory lesion count as continuous covariate.||8.19|-2.47|0.3757
72578819|NCT04856917|144685239|SUPERIORITY||LS Mean Difference|1.6|STANDARD_ERROR_OF_MEAN|3.22||0.6183|TWO_SIDED|90.0|-3.73|6.95|||LRMM|||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline facial inflammatory lesion count as continuous covariate.||6.95|-3.73|0.6183
72578820|NCT04856917|144685240|SUPERIORITY||LS Mean Difference|2.0|STANDARD_ERROR_OF_MEAN|1.7||0.249|TWO_SIDED|90.0|-0.85|4.8||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline facial inflammatory lesion count as continuous covariate.|LRMM|||Imsidolimab 400/200 mg vs Placebo: Week 2||4.80|-0.85|0.2490
72578821|NCT04856917|144685240|SUPERIORITY||LS Mean Difference|3.1|STANDARD_ERROR_OF_MEAN|1.72||0.0708|TWO_SIDED|90.0|0.28|5.99||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline facial inflammatory lesion count as continuous covariate.|LRMM|||Imsidolimab 200/100 mg vs Placebo: Week 2||5.99|0.28|0.0708
72578822|NCT04856917|144685240|SUPERIORITY||LS Mean Difference|7.9|STANDARD_ERROR_OF_MEAN|2.68||0.004|TWO_SIDED|90.0|3.44|12.34||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline facial inflammatory lesion count as continuous covariate.|LRMM|||Imsidolimab 400/200 mg vs Placebo: Week 4||12.34|3.44|0.0040
72578823|NCT04856917|144685240|SUPERIORITY||LS Mean Difference|3.4|STANDARD_ERROR_OF_MEAN|2.71||0.206|TWO_SIDED|90.0|-1.05|7.94||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline facial inflammatory lesion count as continuous covariate.|LRMM|||Imsidolimab 200/100 mg vs Placebo: Week 4||7.94|-1.05|0.2060
72544257|NCT01360632|144618367|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.16||||0.0398|TWO_SIDED|95.0|-0.31|-0.01|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 2 at Week 12. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.||-0.01|-0.31|0.0398
72544258|NCT01360632|144618367|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.13||||0.1168|TWO_SIDED|95.0|-0.3|0.03|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 1 at Week 13. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.||0.03|-0.3|0.1168
72544259|NCT01360632|144618367|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.16||||0.0621|TWO_SIDED|95.0|-0.32|0.01|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 2 at Week 13. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.||0.01|-0.32|0.0621
72544260|NCT01360632|144618367|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.15||||0.089|TWO_SIDED|95.0|-0.32|0.02|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 1 at Week 14. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.||0.02|-0.32|0.089
72544261|NCT01360632|144618367|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2||||0.0213|TWO_SIDED|95.0|-0.38|-0.03|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 2 at Week 14. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.||-0.03|-0.38|0.0213
72544262|NCT01360632|144618368|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.28||||0.0228|TWO_SIDED|95.0|-2.37|-0.18|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 1 at Week 9. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.||-0.18|-2.37|0.0228
72544263|NCT01360632|144618368|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.37||||0.5081|TWO_SIDED|95.0|-1.47|0.73|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 2 at Week 9. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.||0.73|-1.47|0.5081
72329488|NCT03037476|144184394|OTHER|General Linear Model|Slope|0.039||||0.447|TWO_SIDED|95.0|-0.0615|0.1395|||Mixed Models Analysis|Negative Binomial Regression||Change in past month alcohol frequency at 6 month follow-up||0.1395|-.0615|0.447
72544264|NCT01360632|144618368|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.86||||0.0064|TWO_SIDED|95.0|-3.2|-0.53|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 1 at Week 10. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.||-0.53|-3.2|0.0064
72578824|NCT04856917|144685240|SUPERIORITY||LS Mean Difference|2.1|STANDARD_ERROR_OF_MEAN|2.66||0.4341|TWO_SIDED|90.0|-2.33|6.51||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline facial inflammatory lesion count as continuous covariate.|LRMM|||Imsidolimab 400/200 mg vs Placebo: Week 8||6.51|-2.33|0.4341
72578825|NCT04856917|144685240|SUPERIORITY||LS Mean Difference|0.9|STANDARD_ERROR_OF_MEAN|2.73||0.7307|TWO_SIDED|90.0|-3.59|5.48||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline facial inflammatory lesion count as continuous covariate.|LRMM|||Imsidolimab 200/100 mg vs Placebo: Week 8||5.48|-3.59|0.7307
72578826|NCT04856917|144685240|SUPERIORITY||LS Mean Difference|2.9|STANDARD_ERROR_OF_MEAN|2.93||0.3261|TWO_SIDED|90.0|-1.97|7.77||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline facial inflammatory lesion count as continuous covariate.|LRMM|||Imsidolimab 400/200 mg vs Placebo: Week 20||7.77|-1.97|0.3261
72578827|NCT04856917|144685240|SUPERIORITY||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|2.95||0.8221|TWO_SIDED|90.0|-5.56|4.23||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline facial inflammatory lesion count as continuous covariate.|LRMM|||Imsidolimab 200/100 mg vs Placebo: Week 20||4.23|-5.56|0.8221
72578828|NCT04856917|144685241|SUPERIORITY||LS Mean Difference|6.4|STANDARD_ERROR_OF_MEAN|6.2||0.3008|TWO_SIDED|90.0|-3.84|16.73||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline facial inflammatory lesion count as continuous covariate.|LRMM|||Imsidolimab 400/200 mg vs Placebo: Week 2||16.73|-3.84|0.3008
72578829|NCT04856917|144685241|SUPERIORITY||LS Mean Difference|10.8|STANDARD_ERROR_OF_MEAN|6.27||0.0878|TWO_SIDED|90.0|0.4|21.19||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline facial inflammatory lesion count as continuous covariate.|LRMM|||Imsidolimab 200/100 mg vs Placebo: Week 2||21.19|0.40|0.0878
72578830|NCT04856917|144685241|SUPERIORITY||LS Mean Difference|26.6|STANDARD_ERROR_OF_MEAN|8.42||0.002|TWO_SIDED|90.0|12.64|40.57||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline facial inflammatory lesion count as continuous covariate.|LRMM|||Imsidolimab 400/200 mg vs Placebo: Week 4||40.57|12.64|0.0020
72578831|NCT04856917|144685241|SUPERIORITY||LS Mean Difference|14.0|STANDARD_ERROR_OF_MEAN|8.5||0.1029|TWO_SIDED|90.0|-0.12|28.09||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline facial inflammatory lesion count as continuous covariate.|LRMM|||Imsidolimab 200/100 mg vs Placebo: Week 4||28.09|-0.12|0.1029
72578832|NCT04856917|144685241|SUPERIORITY||LS Mean Difference|5.4|STANDARD_ERROR_OF_MEAN|8.82||0.5427|TWO_SIDED|90.0|-9.25|20.02||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline facial inflammatory lesion count as continuous covariate.|LRMM|||Imsidolimab 400/200 mg vs Placebo: Week 8||20.02|-9.25|0.5427
72578833|NCT04856917|144685241|SUPERIORITY||LS Mean Difference|5.0|STANDARD_ERROR_OF_MEAN|9.06||0.5833|TWO_SIDED|90.0|-10.05|20.02||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline facial inflammatory lesion count as continuous covariate.|LRMM|||Imsidolimab 200/100 mg vs Placebo: Week 8||20.02|-10.05|0.5833
72578834|NCT04856917|144685241|SUPERIORITY||LS Mean Difference|10.8|STANDARD_ERROR_OF_MEAN|10.98||0.3293|TWO_SIDED|90.0|-7.46|28.99||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline facial inflammatory lesion count as continuous covariate.|LRMM|||Imsidolimab 400/200 mg vs Placebo: Week 12||28.99|-7.46|0.3293
72578835|NCT04856917|144685241|SUPERIORITY||LS Mean Difference|14.5|STANDARD_ERROR_OF_MEAN|10.99||0.19|TWO_SIDED|90.0|-3.74|32.74||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline facial inflammatory lesion count as continuous covariate.|LRMM|||Imsidolimab 200/100 mg vs Placebo: Week 12||32.74|-3.74|0.1900
72578836|NCT04856917|144685241|SUPERIORITY||LS Mean Difference|11.7|STANDARD_ERROR_OF_MEAN|9.38||0.2168|TWO_SIDED|90.0|-3.91|27.23||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline facial inflammatory lesion count as continuous covariate.|LRMM|||Imsidolimab 400/200 mg vs Placebo: Week 20||27.23|-3.91|0.2168
72578837|NCT04856917|144685241|SUPERIORITY||LS Mean Difference|7.8|STANDARD_ERROR_OF_MEAN|9.42||0.4089|TWO_SIDED|90.0|-7.82|23.45||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline facial inflammatory lesion count as continuous covariate.|LRMM|||Imsidolimab 200/100 mg vs Placebo: Week 20||23.45|-7.82|0.4089
72544265|NCT01360632|144618368|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.89||||0.1898|TWO_SIDED|95.0|-2.23|0.44|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 2 at Week 10. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.||0.44|-2.23|0.1898
72544266|NCT01360632|144618368|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.09||||0.0074|TWO_SIDED|95.0|-3.62|-0.56|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 1 at Week 11. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.||-0.56|-3.62|0.0074
72544267|NCT01360632|144618368|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.42||||0.5935|TWO_SIDED|95.0|-1.95|1.11|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 2 at Week 11. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.||1.11|-1.95|0.5935
72544268|NCT01360632|144618368|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.9||||0.0211|TWO_SIDED|95.0|-3.52|-0.29|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 1 at Week 12. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.||-0.29|-3.52|0.0211
72544269|NCT01360632|144618368|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.34||||0.1031|TWO_SIDED|95.0|-2.96|0.27|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 2 at Week 12. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.||0.27|-2.96|0.1031
72544270|NCT01360632|144618368|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1366||||0.1366|TWO_SIDED|95.0|-3.02|0.41|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 1 at Week 13. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.||0.41|-3.02|0.1366
72544271|NCT01360632|144618368|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.96||||0.2709|TWO_SIDED|95.0|-2.68|0.75|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 2 at Week 13. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.||0.75|-2.68|0.2709
72544272|NCT01360632|144618368|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.6||||0.0812|TWO_SIDED|95.0|-3.4|0.2|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 1 at Week 14. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.||0.2|-3.4|0.0812
72544273|NCT01360632|144618368|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.52||||0.1001|TWO_SIDED|95.0|-3.33|0.29|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 2 at Week 14. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.||0.29|-3.33|0.1001
72578838|NCT04856917|144685242|SUPERIORITY||LS Mean Difference|2.0|STANDARD_ERROR_OF_MEAN|2.53||0.4229|TWO_SIDED|90.0|-2.16|6.24||LS Mean, SE, 90% CI, \& p-value was based on LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs 4) as categorical covariates \& baseline facial non-inflammatory lesion count as continuous covariate|LRMM|||Imsidolimab 400/200 mg vs Placebo: Week 2||6.24|-2.16|0.4229
72544274|NCT01360632|144618369|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.12||||0.0496|TWO_SIDED|95.0|-2.24|0.0|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 1 at Week 9. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.||0|-2.24|0.0496
72578839|NCT04856917|144685242|SUPERIORITY||LS Mean Difference|1.3|STANDARD_ERROR_OF_MEAN|2.56||0.6027|TWO_SIDED|90.0|-2.91|5.59||LS Mean, SE, 90% CI, \& p-value was based on LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs 4) as categorical covariates \& baseline facial non-inflammatory lesion count as continuous covariate|LRMM|||Imsidolimab 200/100 mg vs Placebo: Week 2||5.59|-2.91|0.6027
72578840|NCT04856917|144685242|SUPERIORITY||LS Mean Difference|2.8|STANDARD_ERROR_OF_MEAN|2.5||0.2655|TWO_SIDED|90.0|-1.35|6.95||LS Mean, SE, 90% CI, \& p-value was based on LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs 4) as categorical covariates \& baseline facial non-inflammatory lesion count as continuous covariate|LRMM|||Imsidolimab 400/200 mg vs Placebo: Week 4||6.95|-1.35|0.2655
72544275|NCT01360632|144618369|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.49||||0.387|TWO_SIDED|95.0|-1.61|0.63|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 2 at Week 9. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.||0.63|-1.61|0.387
72544276|NCT01360632|144618369|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.75||||0.0125|TWO_SIDED|95.0|-3.13|-0.38|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 1 at Week 10. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.||-0.38|-3.13|0.0125
72544277|NCT01360632|144618369|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.19||||0.0898|TWO_SIDED|95.0|-2.57|0.19|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 2 at Week 10. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.||0.19|-2.57|0.0898
72544278|NCT01360632|144618369|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.31||||0.004|TWO_SIDED|95.0|-3.88|-0.74|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 1 at Week 11. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.||-0.74|-3.88|0.004
72544279|NCT01360632|144618369|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.83||||0.301|TWO_SIDED|95.0|-2.4|0.74|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 2 at Week 11. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.||0.74|-2.4|0.301
72544280|NCT01360632|144618369|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.15||||0.0118|TWO_SIDED|95.0|-3.82|-0.48|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 1 at Week 12. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.||-0.48|-3.82|0.0118
72544281|NCT01360632|144618369|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.87||||0.0287|TWO_SIDED|95.0|-3.54|-0.19|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 2 at Week 12. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.||-0.19|-3.54|0.0287
72544282|NCT01360632|144618369|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.63||||0.0686|TWO_SIDED|95.0|-3.39|0.12|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 1 at Week 13. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.||0.12|-3.39|0.0686
72544283|NCT01360632|144618369|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.72||||0.056|TWO_SIDED|95.0|-3.47|0.04|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 2 at Week 13. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.||0.04|-3.47|0.056
72578841|NCT04856917|144685242|SUPERIORITY||LS Mean Difference|1.2|STANDARD_ERROR_OF_MEAN|2.53||0.6229|TWO_SIDED|90.0|-2.95|5.44||LS Mean, SE, 90% CI, \& p-value was based on LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs 4) as categorical covariates \& baseline facial non-inflammatory lesion count as continuous covariate|LRMM|||Imsidolimab 200/100 mg vs Placebo: Week 4||5.44|-2.95|0.6229
72544284|NCT01360632|144618369|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.9||||0.0448|TWO_SIDED|95.0|-3.75|-0.04|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 1 at Week 14. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.||-0.04|-3.75|0.0448
72544285|NCT01360632|144618369|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.13||||0.0251|TWO_SIDED|95.0|-3.98|-0.27|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 2 at Week 14. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.||-0.27|-3.98|0.0251
72544286|NCT01360632|144618370|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.67||||0.1732|TWO_SIDED|95.0|-1.63|0.29|||ANCOVA|||Statistical analysis 1 at Week 14. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The last observation carried forward (LOCF) method was used to impute missing data.||0.29|-1.63|0.1732
72578842|NCT04856917|144685242|SUPERIORITY||LS Mean Difference|3.1|STANDARD_ERROR_OF_MEAN|3.74||0.4091|TWO_SIDED|90.0|-3.1|9.3||LS Mean, SE, 90% CI, \& p-value was based on LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs 4) as categorical covariates \& baseline facial non-inflammatory lesion count as continuous covariate|LRMM|||Imsidolimab 400/200 mg vs Placebo: Week 8||9.30|-3.10|0.4091
72578843|NCT04856917|144685242|SUPERIORITY||LS Mean Difference|5.9|STANDARD_ERROR_OF_MEAN|3.83||0.1274|TWO_SIDED|90.0|-0.47|12.25||LS Mean, SE, 90% CI, \& p-value was based on LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs 4) as categorical covariates \& baseline facial non-inflammatory lesion count as continuous covariate|LRMM|||Imsidolimab 200/100 mg vs Placebo: Week 8||12.25|-0.47|0.1274
72578844|NCT04856917|144685242|SUPERIORITY||LS Mean Difference|4.8|STANDARD_ERROR_OF_MEAN|3.76||0.2075|TWO_SIDED|90.0|-1.47|11.01||LS Mean, SE, 90% CI, \& p-value was based on LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs 4) as categorical covariates \& baseline facial non-inflammatory lesion count as continuous covariate|LRMM|||Imsidolimab 400/200 mg vs Placebo: Week 12||11.01|-1.47|0.2075
72578845|NCT04856917|144685242|SUPERIORITY||LS Mean Difference|4.4|STANDARD_ERROR_OF_MEAN|3.77||0.2484|TWO_SIDED|90.0|-1.88|10.64||LS Mean, SE, 90% CI, \& p-value was based on LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs 4) as categorical covariates \& baseline facial non-inflammatory lesion count as continuous covariate|LRMM|||Imsidolimab 200/100 mg vs Placebo: Week 12||10.64|-1.88|0.2484
72578846|NCT04856917|144685242|SUPERIORITY||LS Mean Difference|3.5|STANDARD_ERROR_OF_MEAN|3.61||0.3399|TWO_SIDED|90.0|-2.53|9.45||LS Mean, SE, 90% CI, \& p-value was based on LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs 4) as categorical covariates \& baseline facial non-inflammatory lesion count as continuous covariate|LRMM|||Imsidolimab 400/200 mg vs Placebo: Week 20||9.45|-2.53|0.3399
72578847|NCT04856917|144685242|SUPERIORITY||LS Mean Difference|7.0|STANDARD_ERROR_OF_MEAN|3.62||0.0545|TWO_SIDED|90.0|1.03|13.05||LS Mean, SE, 90% CI, \& p-value was based on LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs 4) as categorical covariates \& baseline facial non-inflammatory lesion count as continuous covariate|LRMM|||Imsidolimab 200/100 mg vs Placebo: Week 20||13.05|1.03|0.0545
72578848|NCT04856917|144685243|SUPERIORITY||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|11.69||0.9679|TWO_SIDED|90.0|-19.86|18.91||LS Mean, SE, 90% CI, \& p-value was based on LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs 4) as categorical covariates \& baseline facial non-inflammatory lesion count as continuous covariate|LRMM|||Imsidolimab 400/200 mg vs Placebo: Week 2||18.91|-19.86|0.9679
72578849|NCT04856917|144685243|SUPERIORITY||LS Mean Difference|-1.3|STANDARD_ERROR_OF_MEAN|11.83||0.9152|TWO_SIDED|90.0|-20.87|18.35||LS Mean, SE, 90% CI, \& p-value was based on LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs 4) as categorical covariates \& baseline facial non-inflammatory lesion count as continuous covariate|LRMM|||Imsidolimab 200/100 mg vs Placebo: Week 2||18.35|-20.87|0.9152
72578850|NCT04856917|144685243|SUPERIORITY||LS Mean Difference|7.3|STANDARD_ERROR_OF_MEAN|9.64||0.449|TWO_SIDED|90.0|-8.67|23.32||LS Mean, SE, 90% CI, \& p-value was based on LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs 4) as categorical covariates \& baseline facial non-inflammatory lesion count as continuous covariate|LRMM|||Imsidolimab 400/200 mg vs Placebo: Week 4||23.32|-8.67|0.4490
72578851|NCT04856917|144685243|SUPERIORITY||LS Mean Difference|3.4|STANDARD_ERROR_OF_MEAN|9.74||0.7246|TWO_SIDED|90.0|-12.72|19.6||LS Mean, SE, 90% CI, \& p-value was based on LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs 4) as categorical covariates \& baseline facial non-inflammatory lesion count as continuous covariate|LRMM|||Imsidolimab 200/100 mg vs Placebo: Week 4||19.60|-12.72|0.7246
72578852|NCT04856917|144685243|SUPERIORITY||LS Mean Difference|13.8|STANDARD_ERROR_OF_MEAN|18.88||0.4655|TWO_SIDED|90.0|-17.49|45.14||LS Mean, SE, 90% CI, \& p-value was based on LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs 4) as categorical covariates \& baseline facial non-inflammatory lesion count as continuous covariate|LRMM|||Imsidolimab 400/200 mg vs Placebo: Week 8||45.14|-17.49|0.4655
72578853|NCT04856917|144685243|SUPERIORITY||LS Mean Difference|30.5|STANDARD_ERROR_OF_MEAN|19.33||0.1178|TWO_SIDED|90.0|-1.59|62.54||LS Mean, SE, 90% CI, \& p-value was based on LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs 4) as categorical covariates \& baseline facial non-inflammatory lesion count as continuous covariate|LRMM|||Imsidolimab 200/100 mg vs Placebo: Week 8||62.54|-1.59|0.1178
72578854|NCT04856917|144685243|SUPERIORITY||LS Mean Difference|23.1|STANDARD_ERROR_OF_MEAN|17.71||0.1938|TWO_SIDED|90.0|-6.22|52.52||LS Mean, SE, 90% CI, \& p-value was based on LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs 4) as categorical covariates \& baseline facial non-inflammatory lesion count as continuous covariate|LRMM|||Imsidolimab 400/200 mg vs Placebo: Week 12||52.52|-6.22|0.1938
72578855|NCT04856917|144685243|SUPERIORITY||LS Mean Difference|29.7|STANDARD_ERROR_OF_MEAN|17.85||0.0991|TWO_SIDED|90.0|0.08|59.29||LS Mean, SE, 90% CI, \& p-value was based on LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs 4) as categorical covariates \& baseline facial non-inflammatory lesion count as continuous covariate|LRMM|||Imsidolimab 200/100 mg vs Placebo: Week 12||59.29|0.08|0.0991
72578856|NCT04856917|144685243|SUPERIORITY||LS Mean Difference|15.0|STANDARD_ERROR_OF_MEAN|15.44||0.3337|TWO_SIDED|90.0|-10.62|40.59||LS Mean, SE, 90% CI, \& p-value was based on LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs 4) as categorical covariates \& baseline facial non-inflammatory lesion count as continuous covariate|LRMM|||Imsidolimab 400/200 mg vs Placebo: Week 20||40.59|-10.62|0.3337
72578857|NCT04856917|144685243|SUPERIORITY||LS Mean Difference|31.2|STANDARD_ERROR_OF_MEAN|15.48||0.0465|TWO_SIDED|90.0|5.5|56.87||LS Mean, SE, 90% CI, \& p-value was based on LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs 4) as categorical covariates \& baseline facial non-inflammatory lesion count as continuous covariate|LRMM|||Imsidolimab 200/100 mg vs Placebo: Week 20||56.87|5.50|0.0465
72578858|NCT04856917|144685244|SUPERIORITY||LS Mean Difference|3.7|STANDARD_ERROR_OF_MEAN|2.95||0.215|TWO_SIDED|90.0|-1.21|8.56||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline total facial lesion count as continuous covariate.|LRMM|||Imsidolimab 400/200 mg vs Placebo: Week 2||8.56|-1.21|0.2150
72578859|NCT04856917|144685244|SUPERIORITY||LS Mean Difference|5.1|STANDARD_ERROR_OF_MEAN|2.97||0.0864|TWO_SIDED|90.0|0.21|10.05||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline total facial lesion count as continuous covariate.|LRMM|||Imsidolimab 200/100 mg vs Placebo: Week 2||10.05|0.21|0.0864
72578860|NCT04856917|144685244|SUPERIORITY||LS Mean Difference|10.4|STANDARD_ERROR_OF_MEAN|3.88||0.0084|TWO_SIDED|90.0|3.97|16.85||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline total facial lesion count as continuous covariate.|LRMM|||Imsidolimab 400/200 mg vs Placebo: Week 4||16.85|3.97|0.0084
72578861|NCT04856917|144685244|SUPERIORITY||LS Mean Difference|5.5|STANDARD_ERROR_OF_MEAN|3.91||0.16|TWO_SIDED|90.0|-0.95|12.01||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline total facial lesion count as continuous covariate.|LRMM|||Imsidolimab 200/100 mg vs Placebo: Week 4||12.01|-0.95|0.1600
72578862|NCT04856917|144685244|SUPERIORITY||LS Mean Difference|4.7|STANDARD_ERROR_OF_MEAN|5.23||0.3671|TWO_SIDED|90.0|-3.94|13.41||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline total facial lesion count as continuous covariate.|LRMM|||Imsidolimab 400/200 mg vs Placebo: Week 8||13.41|-3.94|0.3671
72578863|NCT04856917|144685244|SUPERIORITY||LS Mean Difference|7.6|STANDARD_ERROR_OF_MEAN|5.35||0.1587|TWO_SIDED|90.0|-1.28|16.46||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline total facial lesion count as continuous covariate.|LRMM|||Imsidolimab 200/100 mg vs Placebo: Week 8||16.46|-1.28|0.1587
72578864|NCT04856917|144685244|SUPERIORITY||LS Mean Difference|7.6|STANDARD_ERROR_OF_MEAN|5.8||0.1932|TWO_SIDED|90.0|-2.03|17.21||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline total facial lesion count as continuous covariate.|LRMM|||Imsidolimab 400/200 mg vs Placebo: Week 12||17.21|-2.03|0.1932
72578865|NCT04856917|144685244|SUPERIORITY||LS Mean Difference|6.7|STANDARD_ERROR_OF_MEAN|5.82||0.2518|TWO_SIDED|90.0|-2.95|16.37||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline total facial lesion count as continuous covariate.|LRMM|||Imsidolimab 200/100 mg vs Placebo: Week 12||16.37|-2.95|0.2518
72329489|NCT03037476|144184394|OTHER|General Linear Model|Slope|0.0398||||0.443|TWO_SIDED|95.0|-0.0619|0.1414|||Mixed Models Analysis|Negative Binomial Regression||Change in past month alcohol frequency at 12 month follow-up||0.1414|-0.0619|0.443
72578866|NCT04856917|144685244|SUPERIORITY||LS Mean Difference|6.7|STANDARD_ERROR_OF_MEAN|5.53||0.232|TWO_SIDED|90.0|-2.53|15.83||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline total facial lesion count as continuous covariate.|LRMM|||Imsidolimab 400/200 mg vs Placebo: Week 20||15.83|-2.53|0.2320
72578867|NCT04856917|144685244|SUPERIORITY||LS Mean Difference|7.1|STANDARD_ERROR_OF_MEAN|5.55||0.2014|TWO_SIDED|90.0|-2.08|16.35||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline total facial lesion count as continuous covariate.|LRMM|||Imsidolimab 200/100 mg vs Placebo: Week 20||16.35|-2.08|0.2014
72578868|NCT04856917|144685245|SUPERIORITY||LS Mean Difference|3.9|STANDARD_ERROR_OF_MEAN|4.94||0.4361|TWO_SIDED|90.0|-4.34|12.06||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline total facial lesion count as continuous covariate.|LRMM|||Imsidolimab 400/200 mg vs Placebo: Week 2||12.06|-4.34|0.4361
72578869|NCT04856917|144685245|SUPERIORITY||LS Mean Difference|8.2|STANDARD_ERROR_OF_MEAN|4.98||0.1018|TWO_SIDED|90.0|-0.04|16.48||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline total facial lesion count as continuous covariate.|LRMM|||Imsidolimab 200/100 mg vs Placebo: Week 2||16.48|-0.04|0.1018
72578870|NCT04856917|144685245|SUPERIORITY||LS Mean Difference|16.3|STANDARD_ERROR_OF_MEAN|5.79||0.0059|TWO_SIDED|90.0|6.66|25.88||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline total facial lesion count as continuous covariate.|LRMM|||Imsidolimab 400/200 mg vs Placebo: Week 4||25.88|6.66|0.0059
72578871|NCT04856917|144685245|SUPERIORITY||LS Mean Difference|9.9|STANDARD_ERROR_OF_MEAN|5.83||0.0913|TWO_SIDED|90.0|0.26|19.59||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline total facial lesion count as continuous covariate.|LRMM|||Imsidolimab 200/100 mg vs Placebo: Week 4||19.59|0.26|0.0913
72578872|NCT04856917|144685245|SUPERIORITY||LS Mean Difference|5.3|STANDARD_ERROR_OF_MEAN|7.7||0.4921|TWO_SIDED|90.0|-7.47|18.09||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline total facial lesion count as continuous covariate.|LRMM|||Imsidolimab 400/200 mg vs Placebo: Week 8||18.09|-7.47|0.4921
72578873|NCT04856917|144685245|SUPERIORITY||LS Mean Difference|11.1|STANDARD_ERROR_OF_MEAN|7.89||0.1607|TWO_SIDED|90.0|-1.95|24.24||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline total facial lesion count as continuous covariate.|LRMM|||Imsidolimab 200/100 mg vs Placebo: Week 8||24.24|-1.95|0.1607
72578874|NCT04856917|144685245|SUPERIORITY||LS Mean Difference|14.2|STANDARD_ERROR_OF_MEAN|9.19||0.1244|TWO_SIDED|90.0|-1.02|29.48||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline total facial lesion count as continuous covariate.|LRMM|||Imsidolimab 400/200 mg vs Placebo: Week 12||29.48|-1.02|0.1244
72578875|NCT04856917|144685245|SUPERIORITY||LS Mean Difference|15.2|STANDARD_ERROR_OF_MEAN|9.2||0.1004|TWO_SIDED|90.0|-0.02|30.51||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline total facial lesion count as continuous covariate.|LRMM|||Imsidolimab 200/100 mg vs Placebo: Week 12||30.51|-0.02|0.1004
72578876|NCT04856917|144685245|SUPERIORITY||LS Mean Difference|12.4|STANDARD_ERROR_OF_MEAN|9.64||0.2015|TWO_SIDED|90.0|-3.61|28.39||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline total facial lesion count as continuous covariate.|LRMM|||Imsidolimab 400/200 mg vs Placebo: Week 20||28.39|-3.61|0.2015
72578877|NCT04856917|144685245|SUPERIORITY||LS Mean Difference|15.8|STANDARD_ERROR_OF_MEAN|9.66||0.1057|TWO_SIDED|90.0|-0.27|31.81||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline total facial lesion count as continuous covariate.|LRMM|||Imsidolimab 200/100 mg vs Placebo: Week 20||31.81|-0.27|0.1057
72578878|NCT04856917|144685246|SUPERIORITY||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.08||0.5157|TWO_SIDED|90.0|-0.08|0.19||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline facial IGA as continuous covariate.|LRMM|||Imsidolimab 400/200 mg vs Placebo: Week 2||0.19|-0.08|0.5157
72578879|NCT04856917|144685246|SUPERIORITY||LS Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|0.08||0.0178|TWO_SIDED|90.0|0.06|0.34||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline facial IGA as continuous covariate.|LRMM|||Imsidolimab 200/100 mg vs Placebo: Week 2||0.34|0.06|0.0178
72578880|NCT04856917|144685246|SUPERIORITY||LS Mean Difference|0.3|STANDARD_DEVIATION|0.12||0.0132|TWO_SIDED|90.0|0.1|0.48||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline facial IGA as continuous covariate.|LRMM|||Imsidolimab 400/200 mg vs Placebo: Week 4||0.48|0.10|0.0132
72578881|NCT04856917|144685246|SUPERIORITY||LS Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|0.12||0.0034|TWO_SIDED|90.0|0.16|0.54||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline facial IGA as continuous covariate.|LRMM|||Imsidolimab 200/100 mg vs Placebo: Week 4||0.54|0.16|0.0034
72578882|NCT04856917|144685246|SUPERIORITY||LS Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|0.13||0.051|TWO_SIDED|90.0|0.04|0.47||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline facial IGA as continuous covariate.|LRMM|||Imsidolimab 400/200 mg vs Placebo: Week 8||0.47|0.04|0.0510
72578883|NCT04856917|144685246|SUPERIORITY||LS Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|0.13||0.0608|TWO_SIDED|90.0|0.03|0.47||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline facial IGA as continuous covariate.|LRMM|||Imsidolimab 200/100 mg vs Placebo: Week 8||0.47|0.03|0.0608
72578884|NCT04856917|144685246|SUPERIORITY||LS Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|0.17||0.2702|TWO_SIDED|90.0|-0.1|0.48||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline facial IGA as continuous covariate.|LRMM|||Imsidolimab 400/200 mg vs Placebo: Week 12||0.48|-0.10|0.2702
72578885|NCT04856917|144685246|SUPERIORITY||LS Mean Difference|0.4|STANDARD_ERROR_OF_MEAN|0.17||0.0249|TWO_SIDED|90.0|0.11|0.69||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline facial IGA as continuous covariate.|LRMM|||Imsidolimab 200/100 mg vs Placebo: Week 12||0.69|0.11|0.0249
72578886|NCT04856917|144685246|SUPERIORITY||LS Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|0.18||0.1853|TWO_SIDED|90.0|-0.06|0.55||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline facial IGA as continuous covariate.|LRMM|||Imsidolimab 400/200 mg vs Placebo: Week 20||0.55|-0.06|0.1853
72578887|NCT04856917|144685246|SUPERIORITY||LS Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|0.18||0.2974|TWO_SIDED|90.0|-0.11|0.5||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline facial IGA as continuous covariate.|LRMM|||Imsidolimab 200/100 mg vs Placebo: Week 20||0.50|-0.11|0.2974
72578888|NCT04856917|144685247|SUPERIORITY||Risk Difference (RD)|-2.5||||0.339|TWO_SIDED|90.0|-6.62|1.63||P-value for the adjusted risk difference between imsidolimab and placebo was obtained from generalized Cochran-Mantel-Haenszel test (ANOVA for row means), adjusting for facial IGA score at baseline.|Cochran-Mantel-Haenszel|||Imsidolimab 400/200 mg vs Placebo: Week 4||1.63|-6.62|0.3390
72578889|NCT04856917|144685247|SUPERIORITY||Risk Difference (RD)|-2.6||||0.3243|TWO_SIDED|90.0|-6.79|1.59||P-value for the adjusted risk difference between imsidolimab and placebo was obtained from generalized Cochran-Mantel-Haenszel test (ANOVA for row means), adjusting for facial IGA score at baseline.|Cochran-Mantel-Haenszel|||Imsidolimab 200/100 mg vs Placebo: Week 4||1.59|-6.79|0.3243
72578890|NCT04856917|144685247|SUPERIORITY||Risk Difference (RD)|0.0||||1|TWO_SIDED|90.0|-5.91|5.91||P-value for the adjusted risk difference between imsidolimab and placebo was obtained from generalized Cochran-Mantel-Haenszel test (ANOVA for row means), adjusting for facial IGA score at baseline.|Cochran-Mantel-Haenszel|||Imsidolimab 400/200 mg vs Placebo: Week 8||5.91|-5.91|1.0000
72578891|NCT04856917|144685247|SUPERIORITY||Risk Difference (RD)|-2.66||||0.332|TWO_SIDED|90.0|-6.96|1.63||P-value for the adjusted risk difference between imsidolimab and placebo was obtained from generalized Cochran-Mantel-Haenszel test (ANOVA for row means), adjusting for facial IGA score at baseline.|Cochran-Mantel-Haenszel|||Imsidolimab 200/100 mg vs Placebo: Week 8||1.63|-6.96|0.3320
72578892|NCT04856917|144685247|SUPERIORITY||Risk Difference (RD)|-2.45||||0.7595|TWO_SIDED|90.0|-15.5|10.59||P-value for the adjusted risk difference between imsidolimab and placebo was obtained from generalized Cochran-Mantel-Haenszel test (ANOVA for row means), adjusting for facial IGA score at baseline.|Cochran-Mantel-Haenszel|||Imsidolimab 400/200 mg vs Placebo: Week 12||10.59|-15.50|0.7595
72578893|NCT04856917|144685247|SUPERIORITY||Risk Difference (RD)|-14.11||||0.0209|TWO_SIDED|90.0|-23.66|-4.57||P-value for the adjusted risk difference between imsidolimab and placebo was obtained from generalized Cochran-Mantel-Haenszel test (ANOVA for row means), adjusting for facial IGA score at baseline.|Cochran-Mantel-Haenszel|||Imsidolimab 200/100 mg vs Placebo: Week 12||-4.57|-23.66|0.0209
72544287|NCT01360632|144618370|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.34||||0.0066|TWO_SIDED|95.0|-2.31|-0.37|||ANCOVA|||Statistical analysis 2 at Week 14. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The last observation carried forward (LOCF) method was used to impute missing data.||-0.37|-2.31|0.0066
72544288|NCT01360632|144618371|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.78||||0.1226|TWO_SIDED|95.0|-1.78|0.21|||ANCOVA|||Statistical analysis 1 at Week 14. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.||0.21|-1.78|0.1226
72544289|NCT01360632|144618371|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.69||||0.001|TWO_SIDED|95.0|-2.69|-0.68|||ANCOVA|||Statistical analysis 2 at Week 14. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.||-0.68|-2.69|0.001
72544290|NCT01360632|144618372|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.8164|TWO_SIDED|95.0|-0.93|0.73|||ANCOVA|||Statistical analysis 1 at Week 14. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||0.73|-0.93|0.8164
72544291|NCT01360632|144618372|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.55||||0.1939|TWO_SIDED|95.0|-1.39|0.28|||ANCOVA|||Statistical analysis 2 at Week 14. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||0.28|-1.39|0.1939
72544292|NCT01360632|144618373|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.28||||0.5192|TWO_SIDED|95.0|-1.14|0.57|||ANCOVA|||Statistical analysis 1 at Week 14. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.||0.57|-1.14|0.5192
72544293|NCT01360632|144618373|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.88||||0.0443|TWO_SIDED|95.0|-1.75|-0.02|||ANCOVA|||Statistical analysis 2 at Week 14. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.||-0.02|-1.75|0.0443
72544294|NCT01360632|144618374|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.14||||0.0248|TWO_SIDED|95.0|-0.26|-0.02|||Cochran-Mantel-Haenszel|P-value and treatment difference (CI) are derived from Cochran-Mantel-Haenszel (CMH) row mean score differ test controlling for study center.||Statistical analysis 1 at Week 9. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||-0.02|-0.26|0.0248
72578894|NCT04856917|144685247|SUPERIORITY||Risk Difference (RD)|-4.56||||0.6094|TWO_SIDED|90.0|-18.99|9.87||P-value for the adjusted risk difference between imsidolimab and placebo was obtained from generalized Cochran-Mantel-Haenszel test (ANOVA for row means), adjusting for facial IGA score at baseline.|Cochran-Mantel-Haenszel|||Imsidolimab 400/200 mg vs Placebo: Week 20||9.87|-18.99|0.6094
72578895|NCT04856917|144685247|SUPERIORITY||Risk Difference (RD)|-10.28||||0.2076|TWO_SIDED|90.0|-23.34|2.78||P-value for the adjusted risk difference between imsidolimab and placebo was obtained from generalized Cochran-Mantel-Haenszel test (ANOVA for row means), adjusting for facial IGA score at baseline.|Cochran-Mantel-Haenszel|||Imsidolimab 200/100 mg vs Placebo: Week 20||2.78|-23.34|0.2076
72578896|NCT04856917|144685248|SUPERIORITY||Risk Difference (RD)|0.1||||0.4482|TWO_SIDED|90.0|-0.1|0.29||Adjusted P-value obtained from Cochran-Mantel-Haenszel test (ANOVA for row means), adjusting for facial IGA at baseline.|Cochran-Mantel-Haenszel||Somers'D statistic and tanh\^(-1) transformed 90% CI.|Imsidolimab 400/200 mg vs Placebo: Week 2||0.29|-0.10|0.4482
72578897|NCT04856917|144685248|SUPERIORITY||Risk Difference (RD)|0.14||||0.4529|TWO_SIDED|90.0|-0.05|0.33||Adjusted P-value obtained from Cochran-Mantel-Haenszel test (ANOVA for row means), adjusting for facial IGA at baseline.|Cochran-Mantel-Haenszel||Somers'D statistic and tanh\^(-1) transformed 90% CI.|Imsidolimab 200/100 mg vs Placebo: Week 2||0.33|-0.05|0.4529
72578898|NCT04856917|144685248|SUPERIORITY||Risk Difference (RD)|-0.01||||0.932|TWO_SIDED|90.0|-0.2|0.18||Adjusted P-value obtained from Cochran-Mantel-Haenszel test (ANOVA for row means), adjusting for facial IGA at baseline.|Cochran-Mantel-Haenszel||Somers'D statistic and tanh\^(-1) transformed 90% CI.|Imsidolimab 400/200 mg vs Placebo: Week 4||0.18|-0.20|0.9320
72578899|NCT04856917|144685248|SUPERIORITY||Risk Difference (RD)|-0.03||||0.3151|TWO_SIDED|90.0|-0.22|0.16||Adjusted P-value obtained from Cochran-Mantel-Haenszel test (ANOVA for row means), adjusting for facial IGA at baseline.|Cochran-Mantel-Haenszel||Somers'D statistic and tanh\^(-1) transformed 90% CI.|Imsidolimab 200/100 mg vs Placebo: Week 4||0.16|-0.22|0.3151
72578900|NCT04856917|144685248|SUPERIORITY||Risk Difference (RD)|-0.14||||0.2908|TWO_SIDED|90.0|-0.32|0.06||Adjusted P-value obtained from Cochran-Mantel-Haenszel test (ANOVA for row means), adjusting for facial IGA at baseline.|Cochran-Mantel-Haenszel||Somers'D statistic and tanh\^(-1) transformed 90% CI.|Imsidolimab 400/200 mg vs Placebo: Week 8||0.06|-0.32|0.2908
72578901|NCT04856917|144685248|SUPERIORITY||Risk Difference (RD)|0.05||||0.7277|TWO_SIDED|90.0|-0.15|0.24||Adjusted P-value obtained from Cochran-Mantel-Haenszel test (ANOVA for row means), adjusting for facial IGA at baseline.|Cochran-Mantel-Haenszel||Somers'D statistic and tanh\^(-1) transformed 90% CI.|Imsidolimab 200/100 mg vs Placebo: Week 8||0.24|-0.15|0.7277
72578902|NCT04856917|144685248|SUPERIORITY||Risk Difference (RD)|-0.03||||0.8463|TWO_SIDED|90.0|-0.23|0.17||Adjusted P-value obtained from Cochran-Mantel-Haenszel test (ANOVA for row means), adjusting for facial IGA at baseline.|Cochran-Mantel-Haenszel||Somers'D statistic and tanh\^(-1) transformed 90% CI.|Imsidolimab 400/200 mg vs Placebo: Week 12||0.17|-0.23|0.8463
72578903|NCT04856917|144685248|SUPERIORITY||Risk Difference (RD)|-0.08||||0.5281|TWO_SIDED|90.0|-0.28|0.11||Adjusted P-value obtained from Cochran-Mantel-Haenszel test (ANOVA for row means), adjusting for facial IGA at baseline.|Cochran-Mantel-Haenszel||Somers'D statistic and tanh\^(-1) transformed 90% CI.|Imsidolimab 200/100 mg vs Placebo: Week 12||0.11|-0.28|0.5281
72578904|NCT04856917|144685248|SUPERIORITY||Risk Difference (RD)|-0.09||||0.5747|TWO_SIDED|90.0|-0.28|0.11||Adjusted P-value obtained from Cochran-Mantel-Haenszel test (ANOVA for row means), adjusting for facial IGA at baseline.|Cochran-Mantel-Haenszel||Somers'D statistic and tanh\^(-1) transformed 90% CI.|Imsidolimab 400/200 mg vs Placebo: Week 20||0.11|-0.28|0.5747
72578905|NCT04856917|144685248|SUPERIORITY||Risk Difference (RD)|-0.05||||0.5081|TWO_SIDED|90.0|-0.24|0.14||Adjusted P-value obtained from Cochran-Mantel-Haenszel test (ANOVA for row means), adjusting for facial IGA at baseline.|Cochran-Mantel-Haenszel||Somers'D statistic and tanh\^(-1) transformed 90% CI.|Imsidolimab 200/100 mg vs Placebo: Week 20||0.14|-0.24|0.5081
72578906|NCT04856917|144685249|SUPERIORITY||Risk Difference (RD)|0.01||||0.8338|TWO_SIDED|90.0|-0.19|0.2||Adjusted P-value obtained from Cochran-Mantel-Haenszel test (ANOVA for row means), adjusting for facial IGA at baseline.|Cochran-Mantel-Haenszel||Somers'D statistic and tanh\^(-1) transformed 90% CI.|Imsidolimab 400/200 mg vs Placebo: Week 2||0.20|-0.19|0.8338
72578907|NCT04856917|144685249|SUPERIORITY||Risk Difference (RD)|-0.12||||0.1142|TWO_SIDED|90.0|-0.31|0.09||Adjusted P-value obtained from Cochran-Mantel-Haenszel test (ANOVA for row means), adjusting for facial IGA at baseline.|Cochran-Mantel-Haenszel||Somers'D statistic and tanh\^(-1) transformed 90% CI.|Imsidolimab 200/100 mg vs Placebo: Week 2||0.09|-0.31|0.1142
72578908|NCT04856917|144685249|SUPERIORITY||Risk Difference (RD)|-0.2||||0.3433|TWO_SIDED|90.0|-0.38|0.0||Adjusted P-value obtained from Cochran-Mantel-Haenszel test (ANOVA for row means), adjusting for facial IGA at baseline.|Cochran-Mantel-Haenszel||Somers'D statistic and tanh\^(-1) transformed 90% CI.|Imsidolimab 400/200 mg vs Placebo: Week 4||0.00|-0.38|0.3433
72578909|NCT04856917|144685249|SUPERIORITY||Risk Difference (RD)|-0.17||||0.1129|TWO_SIDED|90.0|-0.37|0.04||Adjusted P-value obtained from Cochran-Mantel-Haenszel test (ANOVA for row means), adjusting for facial IGA at baseline.|Cochran-Mantel-Haenszel||Somers'D statistic and tanh\^(-1) transformed 90% CI.|Imsidolimab 200/100 mg vs Placebo: Week 2||0.04|-0.37|0.1129
72578910|NCT04856917|144685249|SUPERIORITY||Risk Difference (RD)|-0.2||||0.2842|TWO_SIDED|90.0|-0.38|0.0||Adjusted P-value obtained from Cochran-Mantel-Haenszel test (ANOVA for row means), adjusting for facial IGA at baseline.|Cochran-Mantel-Haenszel||Somers'D statistic and tanh\^(-1) transformed 90% CI.|Imsidolimab 400/200 mg vs Placebo: Week 8||0.00|-0.38|0.2842
72578911|NCT04856917|144685249|SUPERIORITY||Risk Difference (RD)|-0.34||||0.0212|TWO_SIDED|90.0|-0.52|-0.13||Adjusted P-value obtained from Cochran-Mantel-Haenszel test (ANOVA for row means), adjusting for facial IGA at baseline.|Cochran-Mantel-Haenszel||Somers'D statistic and tanh\^(-1) transformed 90% CI.|Imsidolimab 200/100 mg vs Placebo: Week 8||-0.13|-0.52|0.0212
72578912|NCT04856917|144685249|SUPERIORITY||Risk Difference (RD)|-0.07||||0.7665|TWO_SIDED|90.0|-0.28|0.14||Adjusted P-value obtained from Cochran-Mantel-Haenszel test (ANOVA for row means), adjusting for facial IGA at baseline.|Cochran-Mantel-Haenszel||Somers'D statistic and tanh\^(-1) transformed 90% CI.|Imsidolimab 400/200 mg vs Placebo: Week 12||0.14|-0.28|0.7665
72578913|NCT04856917|144685249|SUPERIORITY||Risk Difference (RD)|-0.22||||0.1777|TWO_SIDED|90.0|-0.42|0.0||Adjusted P-value obtained from Cochran-Mantel-Haenszel test (ANOVA for row means), adjusting for facial IGA at baseline.|Cochran-Mantel-Haenszel||Somers'D statistic and tanh\^(-1) transformed 90% CI.|Imsidolimab 200/100 mg vs Placebo: Week 12||-0.00|-0.42|0.1777
72578914|NCT04856917|144685249|SUPERIORITY||Risk Difference (RD)|-0.12||||0.3741|TWO_SIDED|90.0|-0.33|0.09||Adjusted P-value obtained from Cochran-Mantel-Haenszel test (ANOVA for row means), adjusting for facial IGA at baseline.|Cochran-Mantel-Haenszel||Somers'D statistic and tanh\^(-1) transformed 90% CI.|Imsidolimab 400/200 mg vs Placebo: Week 20||0.09|-0.33|0.3741
72578915|NCT04856917|144685249|SUPERIORITY||Risk Difference (RD)|-0.13||||0.3321|TWO_SIDED|90.0|-0.33|0.09||Adjusted P-value obtained from Cochran-Mantel-Haenszel test (ANOVA for row means), adjusting for facial IGA at baseline.|Cochran-Mantel-Haenszel||Somers'D statistic and tanh\^(-1) transformed 90% CI.|Imsidolimab 200/100 mg vs Placebo: Week 20||0.09|-0.33|0.3321
72578916|NCT04856917|144685250|SUPERIORITY||LS Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|1.11||0.7932|TWO_SIDED|90.0|-1.56|2.14||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline DLQI as continuous covariate.|LRMM|||Imsidolimab 400/200 mg vs Placebo: Week 2||2.14|-1.56|0.7932
72578917|NCT04856917|144685250|SUPERIORITY||LS Mean Difference|0.9|STANDARD_ERROR_OF_MEAN|1.12||0.4365|TWO_SIDED|90.0|-0.99|2.73||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline DLQI as continuous covariate.|LRMM|||Imsidolimab 200/100 mg vs Placebo: Week 2||2.73|-0.99|0.4365
72578918|NCT04856917|144685250|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|1.04||0.8543|TWO_SIDED|90.0|-1.92|1.54||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline DLQI as continuous covariate.|LRMM|||Imsidolimab 400/200 mg vs Placebo: Week 4||1.54|-1.92|0.8543
72578919|NCT04856917|144685250|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|1.05||0.8726|TWO_SIDED|90.0|-1.91|1.58||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline DLQI as continuous covariate.|LRMM|||Imsidolimab 200/100 mg vs Placebo: Week 4||1.58|-1.91|0.8726
72578920|NCT04856917|144685250|SUPERIORITY||LS Mean Difference|0.6|STANDARD_ERROR_OF_MEAN|1.07||0.5983|TWO_SIDED|90.0|-1.22|2.35||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline DLQI as continuous covariate.|LRMM|||Imsidolimab 400/200 mg vs Placebo: Week 8||2.35|-1.22|0.5983
72578921|NCT04856917|144685250|SUPERIORITY||LS Mean Difference|1.0|STANDARD_ERROR_OF_MEAN|1.09||0.3396|TWO_SIDED|90.0|-0.77|2.86||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline DLQI as continuous covariate.|LRMM|||Imsidolimab 200/100 mg vs Placebo: Week 8||2.86|-0.77|0.3396
72329490|NCT03037476|144184395|OTHER|General Linear Model|Slope|0.0002||||0.997|TWO_SIDED|95.0|-0.1066|0.107|||Mixed Models Analysis|Negative Binomial Regression||Change in past month alcohol typical quantity at 6 months||0.1070|-0.1066|0.997
72578922|NCT04856917|144685250|SUPERIORITY||LS Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.97||0.5305|TWO_SIDED|90.0|-2.23|1.01||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline DLQI as continuous covariate.|LRMM|||Imsidolimab 400/200 mg vs Placebo: Week 12||1.01|-2.23|0.5305
72578923|NCT04856917|144685250|SUPERIORITY||LS Mean Difference|1.7|STANDARD_ERROR_OF_MEAN|0.96||0.0819|TWO_SIDED|90.0|0.09|3.29||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline DLQI as continuous covariate.|LRMM|||Imsidolimab 200/100 mg vs Placebo: Week 12||3.29|0.09|0.0819
72578924|NCT04856917|144685250|SUPERIORITY||LS Mean Difference|2.5|STANDARD_ERROR_OF_MEAN|1.09||0.0243|TWO_SIDED|90.0|0.69|4.31||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline DLQI as continuous covariate.|LRMM|||Imsidolimab 400/200 mg vs Placebo: Week 20||4.31|0.69|0.0243
72578925|NCT04856917|144685250|SUPERIORITY||LS Mean Difference|1.7|STANDARD_ERROR_OF_MEAN|1.05||0.1061|TWO_SIDED|90.0|-0.03|3.46||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline DLQI as continuous covariate.|LRMM|||Imsidolimab 200/100 mg vs Placebo: Week 20||3.46|-0.03|0.1061
72578926|NCT04856917|144685251|SUPERIORITY||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|1.67||0.9333|TWO_SIDED|90.0|-2.69|2.97||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline CDLQI as continuous covariate.|LRMM|||Imsidolimab 400/200 mg vs Placebo: Week 2||2.97|-2.69|0.9333
72578927|NCT04856917|144685251|SUPERIORITY||LS Mean Difference|1.4|STANDARD_ERROR_OF_MEAN|1.67||0.3972|TWO_SIDED|90.0|-1.4|4.27||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline CDLQI as continuous covariate.|LRMM|||Imsidolimab 200/100 mg vs Placebo: Week 2||4.27|-1.40|0.3972
72578928|NCT04856917|144685251|SUPERIORITY||LS Mean Difference|2.1|STANDARD_ERROR_OF_MEAN|1.11||0.0662|TWO_SIDED|90.0|0.23|3.99||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline CDLQI as continuous covariate.|LRMM|||Imsidolimab 400/200 mg vs Placebo: Week 4||3.99|0.23|0.0662
72578929|NCT04856917|144685251|SUPERIORITY||LS Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|1.11||0.8898|TWO_SIDED|90.0|-1.73|2.04||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline CDLQI as continuous covariate.|LRMM|||Imsidolimab 200/100 mg vs Placebo: Week 4||2.04|-1.73|0.8898
72578930|NCT04856917|144685251|SUPERIORITY||LS Mean Difference|1.0|STANDARD_ERROR_OF_MEAN|1.06||0.3664|TWO_SIDED|90.0|-0.85|2.82||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline CDLQI as continuous covariate.|LRMM|||Imsidolimab 400/200 mg vs Placebo: Week 8||2.82|-0.85|0.3664
72578931|NCT04856917|144685251|SUPERIORITY||LS Mean Difference|2.1|STANDARD_ERROR_OF_MEAN|1.1||0.0655|TWO_SIDED|90.0|0.25|4.05||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline CDLQI as continuous covariate.|LRMM|||Imsidolimab 200/100 mg vs Placebo: Week 8||4.05|0.25|0.0655
72578932|NCT04856917|144685251|SUPERIORITY||LS Mean Difference|0.5|STANDARD_ERROR_OF_MEAN|1.2||0.6921|TWO_SIDED|90.0|-1.61|2.57||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline CDLQI as continuous covariate.|LRMM|||Imsidolimab 400/200 mg vs Placebo: Week 12||2.57|-1.61|0.6921
72578933|NCT04856917|144685251|SUPERIORITY||LS Mean Difference|2.7|STANDARD_ERROR_OF_MEAN|1.23||0.0406|TWO_SIDED|90.0|0.59|4.88||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline CDLQI as continuous covariate.|LRMM|||Imsidolimab 200/100 mg vs Placebo: Week 12||4.88|0.59|0.0406
72578934|NCT04856917|144685251|SUPERIORITY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|1.04||0.6872|TWO_SIDED|90.0|-2.24|1.38||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline CDLQI as continuous covariate.|LRMM|||Imsidolimab 400/200 mg vs Placebo: Week 20||1.38|-2.24|0.6872
72578935|NCT04856917|144685251|SUPERIORITY||LS Mean Difference|1.1|STANDARD_ERROR_OF_MEAN|1.08||0.3392|TWO_SIDED|90.0|-0.81|2.92||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline CDLQI as continuous covariate.|LRMM|||Imsidolimab 200/100 mg vs Placebo: Week 20||2.92|-0.81|0.3392
72578936|NCT01169337|144685254|SUPERIORITY|||||||0.0005|||||||Log Rank|stratified 1-sided log-rank test||||||0.0005
72578937|NCT03355469|144685285|SUPERIORITY||Mean Difference (Final Values)|3.53||||0.045|TWO_SIDED|95.0|0.08|6.99||Benjamini and Hochberg method was used to decrease the false discovery rate with an overall error rate of 0.05. The B\&H P-value threshold for this comparison was 0.017.|ANCOVA|Linear ANCOVA model adjusted for pre-intervention FMD.||Intention to treat Full Maximum Likelihood based comparisons of baseline covariate adjusted pre- to post-intervention 0 min unscaled FMD change, where the difference is between treatment combination #2 and treatment combination #1 (i.e. treatment combination # 2 - treatment combination #1).||6.99|0.08|0.045
72578938|NCT03355469|144685285|SUPERIORITY||Mean Difference (Final Values)|1.15||||0.507|TWO_SIDED|95.0|-2.42|4.73||Benjamini and Hochberg method was used to decrease the false discovery rate with an overall error rate of 0.05. The B\&H P-value threshold for this comparison was 0.050.|ANCOVA|ANCOVA linear model adjusted for pre-intervention FMD.||Intention to treat Full Maximum Likelihood based comparisons of baseline covariate adjusted pre- to post-intervention 0 min unscaled FMD change, where the difference is between treatment combination #2 and treatment combination #1 (i.e. treatment combination # 2 - treatment combination #1).||4.73|-2.42|0.507
72578939|NCT03355469|144685285|SUPERIORITY||Mean Difference (Final Values)|4.98||||0.014|TWO_SIDED|95.0|1.14|8.83||Benjamini and Hochberg method was used to decrease the false discovery rate with an overall error rate of 0.05. The B\&H P-value threshold for this comparison was 0.008.|ANCOVA|ANCOVA linear model adjusted for pre-intervention FMD.||Intention to treat Full Maximum Likelihood based comparisons of baseline covariate adjusted pre- to post-intervention 0 min unscaled FMD change, where the difference is between treatment combination #2 and treatment combination #1 (i.e. treatment combination # 2 - treatment combination #1).||8.83|1.14|0.014
72578940|NCT03355469|144685285|SUPERIORITY||Mean Difference (Final Values)|2.38||||0.237|TWO_SIDED|95.0|-1.66|6.42||Benjamini and Hochberg method was used to decrease the false discovery rate with an overall error rate of 0.05. The B\&H P-value threshold for this comparison was 0.033.|ANCOVA|ANCOVA linear model adjusted for pre-intervention FMD.||Intention to treat Full Maximum Likelihood based comparisons of baseline covariate adjusted pre- to post-intervention 0 min unscaled FMD change, where the difference is between treatment combination #2 and treatment combination #1 (i.e. treatment combination # 2 - treatment combination #1).||6.42|-1.66|0.237
72578941|NCT03355469|144685285|SUPERIORITY||Mean Difference (Final Values)|1.45||||0.486|TWO_SIDED|95.0|-2.8|5.7||Benjamini and Hochberg method was used to decrease the false discovery rate with an overall error rate of 0.05. The B\&H P-value threshold for this comparison was 0.042.|ANCOVA|ANCOVA linear model adjusted for pre-intervention FMD.||Intention to treat Full Maximum Likelihood based comparisons of baseline covariate adjusted pre- to post-intervention 0 min unscaled FMD change, where the difference is between treatment combination #2 and treatment combination #1 (i.e. treatment combination # 2 - treatment combination #1).||5.70|-2.80|0.486
72578942|NCT03355469|144685285|SUPERIORITY||Mean Difference (Final Values)|3.83||||0.081|TWO_SIDED|95.0|-0.53|8.19||Benjamini and Hochberg method was used to decrease the false discovery rate with an overall error rate of 0.05. The B\&H P-value threshold for this comparison was 0.025.|ANCOVA|ANCOVA linear model adjusted for pre-intervention FMD.||Intention to treat Full Maximum Likelihood based comparisons of baseline covariate adjusted pre- to post-intervention 0 min unscaled FMD change, where the difference is between treatment combination #2 and treatment combination #1 (i.e. treatment combination # 2 - treatment combination #1).||8.19|-0.53|0.081
72578943|NCT03355469|144685286|SUPERIORITY||Mean Difference (Final Values)|0.0073||||0.373|TWO_SIDED|95.0|-0.0093|0.024||Benjamini and Hochberg method was used to decrease the false discovery rate with an overall error rate of 0.05. The B\&H P-value threshold for this comparison was 0.025.|ANCOVA|ANCOVA linear model adjusted for pre-intervention GIR.||Intention to treat Full Maximum Likelihood based comparisons of baseline covariate adjusted pre- to post-intervention GIR, where the difference is between treatment combination #2 and treatment combination #1 (i.e. treatment combination # 2 - treatment combination #1).||0.0240|-0.0093|0.373
72578944|NCT03355469|144685286|SUPERIORITY||Mean Difference (Final Values)|0.0097||||0.198|TWO_SIDED|95.0|-0.0055|0.025||Benjamini and Hochberg method was used to decrease the false discovery rate with an overall error rate of 0.05. The B\&H P-value threshold for this comparison was 0.008.|ANCOVA|ANCOVA linear model adjusted for pre-intervention GIR.||Intention to treat Full Maximum Likelihood based comparisons of baseline covariate adjusted pre- to post-intervention GIR, where the difference is between treatment combination #2 and treatment combination #1 (i.e. treatment combination # 2 - treatment combination #1).||0.0250|-0.0055|0.198
72411391|NCT04079933|144331129|EQUIVALENCE|Null hypothesis = Test and Control groups will have equivalent levels of change from baseline in cigarettes smoked per day; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of change from baseline in cigarettes smoked per day|Mean Difference (Net)|-3.74|||<|0.0001|TWO_SIDED|95.0|-5.14|-2.34|||t-test, 2 sided||"Difference in LS means (Test - Control) using Mixed Effects Repeated Measures Model 2:~Change from baseline= study group + visit + study group\*visit + CPD + Sex + Race + BMI + Age + subject + random error, fitted with unstructured covariance matrix"|Null hypothesis = Test and Control groups will have equivalent levels of change from baseline in cigarettes smoked per day; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of change from baseline in cigarettes smoked per day||-2.34|-5.14|<0.0001
72578945|NCT03355469|144685286|SUPERIORITY||Mean Difference (Final Values)|0.0041||||0.622|TWO_SIDED|95.0|-0.0129|0.0211||Benjamini and Hochberg method was used to decrease the false discovery rate with an overall error rate of 0.05. The B\&H P-value threshold for this comparison was 0.033.|ANCOVA|ANCOVA linear model adjusted for pre-intervention GIR.||Intention to treat Full Maximum Likelihood based comparisons of baseline covariate adjusted pre- to post-intervention GIR, where the difference is between treatment combination #2 and treatment combination #1 (i.e. treatment combination # 2 - treatment combination #1).||0.0211|-0.0129|0.622
72578946|NCT03355469|144685286|SUPERIORITY||Mean Difference (Final Values)|-0.0024||||0.666|TWO_SIDED|95.0|-0.0136|0.0088||Benjamini and Hochberg method was used to decrease the false discovery rate with an overall error rate of 0.05. The B\&H P-value threshold for this comparison was 0.050.|ANCOVA|ANCOVA linear model adjusted for pre-intervention GIR.||Intention to treat Full Maximum Likelihood based comparisons of baseline covariate adjusted pre- to post-intervention GIR, where the difference is between treatment combination #2 and treatment combination #1 (i.e. treatment combination # 2 - treatment combination #1).||0.0088|-0.0136|0.666
72578947|NCT03355469|144685286|SUPERIORITY||Mean Difference (Final Values)|-0.0032||||0.634|TWO_SIDED|95.0|-0.0169|0.0104||Benjamini and Hochberg method was used to decrease the false discovery rate with an overall error rate of 0.05. The B\&H P-value threshold for this comparison was 0.042.|ANCOVA|ANCOVA linear model adjusted for pre-intervention GIR.||Intention to treat Full Maximum Likelihood based comparisons of baseline covariate adjusted pre- to post-intervention GIR, where the difference is between treatment combination #2 and treatment combination #1 (i.e. treatment combination # 2 - treatment combination #1).||0.0104|-0.0169|0.634
72578948|NCT03355469|144685286|SUPERIORITY||Mean Difference (Final Values)|-0.0056||||0.336|TWO_SIDED|95.0|-0.0174|0.0062||Benjamini and Hochberg method was used to decrease the false discovery rate with an overall error rate of 0.05. The B\&H P-value threshold for this comparison was 0.017.|ANCOVA|ANCOVA linear model adjusted for pre-intervention GIR.||Intention to treat Full Maximum Likelihood based comparisons of baseline covariate adjusted pre- to post-intervention GIR, where the difference is between treatment combination #2 and treatment combination #1 (i.e. treatment combination # 2 - treatment combination #1).||0.0062|-0.0174|0.336
72578949|NCT03355469|144685287|SUPERIORITY||Mean Difference (Final Values)|1.51||||0.671|TWO_SIDED|95.0|-5.68|8.69||Benjamini and Hochberg method was used to decrease the false discovery rate with an overall error rate of 0.05. The B\&H P-value threshold for this comparison was 0.042.|ANCOVA|ANCOVA linear model adjusted for pre-intervention AIx75.||Intention to treat Full Maximum Likelihood based comparisons of baseline covariate adjusted pre- to post-intervention AIx75 change, where the difference is between treatment combination #2 and treatment combination #1 (i.e. treatment combination # 2 - treatment combination #1).||8.69|-5.68|0.671
72578950|NCT03355469|144685287|SUPERIORITY||Mean Difference (Final Values)|-4.82||||0.17|TWO_SIDED|95.0|-11.84|2.19||Benjamini and Hochberg method was used to decrease the false discovery rate with an overall error rate of 0.05. The B\&H P-value threshold for this comparison was 0.025.|ANCOVA|ANCOVA linear model adjusted for pre-intervention AIx75.||Intention to treat Full Maximum Likelihood based comparisons of baseline covariate adjusted pre- to post-intervention AIx75 change, where the difference is between treatment combination #2 and treatment combination #1 (i.e. treatment combination # 2 - treatment combination #1).||2.19|-11.84|0.170
72578951|NCT03355469|144685287|SUPERIORITY||Mean Difference (Final Values)|-0.66||||0.839|TWO_SIDED|95.0|-7.29|5.97||Benjamini and Hochberg method was used to decrease the false discovery rate with an overall error rate of 0.05. The B\&H P-value threshold for this comparison was 0.050.|ANCOVA|ANCOVA linear model adjusted for pre-intervention AIx75.||Intention to treat Full Maximum Likelihood based comparisons of baseline covariate adjusted pre- to post-intervention AIx75 change, where the difference is between treatment combination #2 and treatment combination #1 (i.e. treatment combination # 2 - treatment combination #1).||5.97|-7.29|0.839
72411392|NCT04079933|144331130|EQUIVALENCE|Null hypothesis = Test and Control groups will have equivalent levels of percent change from baseline to end of study in cigarettes smoked per day; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of percent change from baseline to end of study in cigarettes smoked per day|Mean Difference (Net)|-22.5|||<|0.0001|TWO_SIDED|95.0|-30.5|-14.5|||t-test, 2 sided||"Difference in Least Square means (Test - Control) using Mixed Effects Repeated Measures Model 1:~Percent Change from baseline = study group + visit + study group\*visit + subject + random error, fitted with unstructured covariance matrix."|Null hypothesis = Test and Control groups will have equivalent levels of percent change from baseline to end of study in cigarettes smoked per day; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of percent change from baseline to end of study in cigarettes smoked per day||-14.5|-30.5|<0.0001
72578952|NCT03355469|144685287|SUPERIORITY||Mean Difference (Final Values)|6.33||||0.024|TWO_SIDED|95.0|0.86|11.8||Benjamini and Hochberg method was used to decrease the false discovery rate with an overall error rate of 0.05. The B\&H P-value threshold for this comparison was 0.008.|ANCOVA|ANCOVA linear model adjusted for pre-intervention AIx75.||Intention to treat Full Maximum Likelihood based comparisons of baseline covariate adjusted pre- to post-intervention AIx75 change, where the difference is between treatment combination #2 and treatment combination #1 (i.e. treatment combination # 2 - treatment combination #1).||11.80|0.86|0.024
72578953|NCT03355469|144685287|SUPERIORITY||Mean Difference (Final Values)|-2.16||||0.385|TWO_SIDED|95.0|-7.16|2.83||Benjamini and Hochberg method was used to decrease the false discovery rate with an overall error rate of 0.05. The B\&H P-value threshold for this comparison was 0.033.|ANCOVA|ANCOVA linear model adjusted for pre-intervention AIx75.||Intention to treat Full Maximum Likelihood based comparisons of baseline covariate adjusted pre- to post-intervention AIx75 change, where the difference is between treatment combination #2 and treatment combination #1 (i.e. treatment combination # 2 - treatment combination #1).||2.83|-7.16|0.385
72578954|NCT03355469|144685287|SUPERIORITY||Mean Difference (Final Values)|4.17||||0.08|TWO_SIDED|95.0|-0.53|8.86||Benjamini and Hochberg method was used to decrease the false discovery rate with an overall error rate of 0.05. The B\&H P-value threshold for this comparison was 0.017.|ANCOVA|ANCOVA linear model adjusted for pre-intervention AIx75.||Intention to treat Full Maximum Likelihood based comparisons of baseline covariate adjusted pre- to post-intervention AIx75 change, where the difference is between treatment combination #2 and treatment combination #1 (i.e. treatment combination # 2 - treatment combination #1).||8.86|-0.53|0.080
72578955|NCT03355469|144685288|SUPERIORITY||Mean Difference (Final Values)|-0.032||||0.088|TWO_SIDED|95.0|-0.069|0.005||Benjamini and Hochberg method was used to decrease the false discovery rate with an overall error rate of 0.05. The B\&H P-value threshold for this comparison was 0.017.|ANCOVA|ANCOVA linear model adjusted for pre-intervention MBF.||Intention to treat Full Maximum Likelihood based comparisons of baseline covariate adjusted pre- to post-intervention MBF change, where the difference is between treatment combination #2 and treatment combination #1 (i.e. treatment combination # 2 - treatment combination #1).||0.005|-0.069|0.088
72578956|NCT03355469|144685288|SUPERIORITY||Mean Difference (Final Values)|0.001||||0.96|TWO_SIDED|95.0|-0.059|0.062||Benjamini and Hochberg method was used to decrease the false discovery rate with an overall error rate of 0.05. The B\&H P-value threshold for this comparison was 0.050.|ANCOVA|ANCOVA linear model adjusted for pre-intervention MBF.||Intention to treat Full Maximum Likelihood based comparisons of baseline covariate adjusted pre- to post-intervention MBF change, where the difference is between treatment combination #2 and treatment combination #1 (i.e. treatment combination # 2 - treatment combination #1).||0.062|-0.059|0.960
72578957|NCT03355469|144685288|SUPERIORITY||Mean Difference (Final Values)|-0.052||||0.075|TWO_SIDED|95.0|-0.109|0.006||Benjamini and Hochberg method was used to decrease the false discovery rate with an overall error rate of 0.05. The B\&H P-value threshold for this comparison was 0.008.|ANCOVA|ANCOVA linear model adjusted for pre-intervention MBF.||Intention to treat Full Maximum Likelihood based comparisons of baseline covariate adjusted pre- to post-intervention MBF change, where the difference is between treatment combination #2 and treatment combination #1 (i.e. treatment combination # 2 - treatment combination #1).||0.006|-0.109|0.075
72578958|NCT03355469|144685288|SUPERIORITY||Mean Difference (Final Values)|-0.033||||0.258|TWO_SIDED|95.0|-0.094|0.028||Benjamini and Hochberg method was used to decrease the false discovery rate with an overall error rate of 0.05. The B\&H P-value threshold for this comparison was 0.033.|ANCOVA|ANCOVA linear model adjusted for pre-intervention MBF.||Intention to treat Full Maximum Likelihood based comparisons of baseline covariate adjusted pre- to post-intervention MBF change, where the difference is between treatment combination #2 and treatment combination #1 (i.e. treatment combination # 2 - treatment combination #1).||0.028|-0.094|0.258
72578959|NCT03355469|144685288|SUPERIORITY||Mean Difference (Final Values)|-0.02||||0.443|TWO_SIDED|95.0|-0.075|0.035||Benjamini and Hochberg method was used to decrease the false discovery rate with an overall error rate of 0.05. The B\&H P-value threshold for this comparison was 0.042.|ANCOVA|ANCOVA linear model adjusted for pre-intervention MBF.||Intention to treat Full Maximum Likelihood based comparisons of baseline covariate adjusted pre- to post-intervention MBF change, where the difference is between treatment combination #2 and treatment combination #1 (i.e. treatment combination # 2 - treatment combination #1).||0.035|-0.075|0.443
72578960|NCT03355469|144685288|SUPERIORITY||Mean Difference (Final Values)|-0.053||||0.144|TWO_SIDED|95.0|-0.126|0.02||Benjamini and Hochberg method was used to decrease the false discovery rate with an overall error rate of 0.05. The B\&H P-value threshold for this comparison was 0.025.|ANCOVA|ANCOVA linear model adjusted for pre-intervention MBF.||Intention to treat Full Maximum Likelihood based comparisons of baseline covariate adjusted pre- to post-intervention MBF change, where the difference is between treatment combination #2 and treatment combination #1 (i.e. treatment combination # 2 - treatment combination #1).||0.020|-0.126|0.144
72544295|NCT01360632|144618374|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.1334|TWO_SIDED|95.0|-0.22|0.03|||Cochran-Mantel-Haenszel|P-value and treatment difference (CI) are derived from CMH row mean scores statistics controlling for study center.||Statistical analysis 2 at Week 9. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||0.03|-0.22|0.1334
72578961|NCT03355469|144685289|SUPERIORITY||Mean Difference (Final Values)|-0.007||||0.147|TWO_SIDED|95.0|-0.017|0.003||Benjamini and Hochberg method was used to decrease the false discovery rate with an overall error rate of 0.05. The B\&H P-value threshold for this comparison was 0.017.|ANCOVA|ANCOVA linear model adjusted for pre-intervention MFV.||Intention to treat Full Maximum Likelihood based comparisons of baseline covariate adjusted pre- to post-intervention MFV change, where the difference is between treatment combination #2 and treatment combination #1 (i.e. treatment combination # 2 - treatment combination #1).||0.003|-0.017|0.147
72578962|NCT03355469|144685289|SUPERIORITY||Mean Difference (Final Values)|0.001||||0.943|TWO_SIDED|95.0|-0.016|0.017||Benjamini and Hochberg method was used to decrease the false discovery rate with an overall error rate of 0.05. The B\&H P-value threshold for this comparison was 0.050.|ANCOVA|ANCOVA linear model adjusted for pre-intervention MFV.||Intention to treat Full Maximum Likelihood based comparisons of baseline covariate adjusted pre- to post-intervention MFV change, where the difference is between treatment combination #2 and treatment combination #1 (i.e. treatment combination # 2 - treatment combination #1).||0.017|-0.016|0.943
72578963|NCT03355469|144685289|SUPERIORITY||Mean Difference (Final Values)|-0.012||||0.108|TWO_SIDED|95.0|-0.027|0.003||Benjamini and Hochberg method was used to decrease the false discovery rate with an overall error rate of 0.05. The B\&H P-value threshold for this comparison was 0.008.|ANCOVA|ANCOVA linear model adjusted for pre-intervention MFV.||Intention to treat Full Maximum Likelihood based comparisons of baseline covariate adjusted pre- to post-intervention MFV change, where the difference is between treatment combination #2 and treatment combination #1 (i.e. treatment combination # 2 - treatment combination #1).||0.003|-0.027|0.108
72578964|NCT03355469|144685289|SUPERIORITY||Mean Difference (Final Values)|-0.008||||0.319|TWO_SIDED|95.0|-0.024|0.009||Benjamini and Hochberg method was used to decrease the false discovery rate with an overall error rate of 0.05. The B\&H P-value threshold for this comparison was 0.033.|ANCOVA|ANCOVA linear model adjusted for pre-intervention MFV.||Intention to treat Full Maximum Likelihood based comparisons of baseline covariate adjusted pre- to post-intervention MFV change, where the difference is between treatment combination #2 and treatment combination #1 (i.e. treatment combination # 2 - treatment combination #1).||0.009|-0.024|0.319
72411393|NCT04079933|144331130|EQUIVALENCE|Null hypothesis = Test and Control groups will have equivalent levels of percent change from baseline to end of study in cigarettes smoked per day; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of percent change from baseline to end of study in cigarettes smoked per day|Mean Difference (Net)|-22.3|||<|0.0001|TWO_SIDED|95.0|-30.4|-14.1|||t-test, 2 sided||"Difference in LS means (Test - Control) using Mixed Effects Repeated Measures Model 2:~%Change from baseline = study group +visit +study group\*visit +CPD +Sex +Race +BMI +Age +subject +random error, fitted with unstructured covariance matrix."|Null hypothesis = Test and Control groups will have equivalent levels of percent change from baseline to end of study in cigarettes smoked per day; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of percent change from baseline to end of study in cigarettes smoked per day||-14.1|-30.4|<0.0001
72578965|NCT03355469|144685289|SUPERIORITY||Mean Difference (Final Values)|-0.005||||0.496|TWO_SIDED|95.0|-0.019|0.01||Benjamini and Hochberg method was used to decrease the false discovery rate with an overall error rate of 0.05. The B\&H P-value threshold for this comparison was 0.042.|ANCOVA|ANCOVA linear model adjusted for pre-intervention MFV.||Intention to treat Full Maximum Likelihood based comparisons of baseline covariate adjusted pre- to post-intervention MFV change, where the difference is between treatment combination #2 and treatment combination #1 (i.e. treatment combination # 2 - treatment combination #1).||0.010|-0.019|0.496
72578966|NCT03355469|144685289|SUPERIORITY||Mean Difference (Final Values)|-0.012||||0.187|TWO_SIDED|95.0|-0.031|0.007||Benjamini and Hochberg method was used to decrease the false discovery rate with an overall error rate of 0.05. The B\&H P-value threshold for this comparison was 0.025.|ANCOVA|ANCOVA linear model adjusted for pre-intervention MFV.||Intention to treat Full Maximum Likelihood based comparisons of baseline covariate adjusted pre- to post-intervention MFV change, where the difference is between treatment combination #2 and treatment combination #1 (i.e. treatment combination # 2 - treatment combination #1).||0.007|-0.031|0.187
72578967|NCT03355469|144685290|SUPERIORITY||Mean Difference (Final Values)|-0.23||||0.086|TWO_SIDED|95.0|-0.495|0.035||Benjamini and Hochberg method was used to decrease the false discovery rate with an overall error rate of 0.05. The B\&H P-value threshold for this comparison was 0.008.|ANCOVA|ANCOVA linear model adjusted for pre-intervention MBV.||Intention to treat Full Maximum Likelihood based comparisons of baseline covariate adjusted pre- to post-intervention MBV change, where the difference is between treatment combination #2 and treatment combination #1 (i.e. treatment combination # 2 - treatment combination #1).||0.035|-0.495|0.086
72578968|NCT03355469|144685290|SUPERIORITY||Mean Difference (Final Values)|0.11||||0.608|TWO_SIDED|95.0|-0.354|0.574||Benjamini and Hochberg method was used to decrease the false discovery rate with an overall error rate of 0.05. The B\&H P-value threshold for this comparison was 0.050.|ANCOVA|ANCOVA linear model adjusted for pre-intervention MBV.||Intention to treat Full Maximum Likelihood based comparisons of baseline covariate adjusted pre- to post-intervention MBV change, where the difference is between treatment combination #2 and treatment combination #1 (i.e. treatment combination # 2 - treatment combination #1).||0.574|-0.354|0.608
72578969|NCT03355469|144685290|SUPERIORITY||Mean Difference (Final Values)|-0.344||||0.11|TWO_SIDED|95.0|-0.779|0.09||Benjamini and Hochberg method was used to decrease the false discovery rate with an overall error rate of 0.05. The B\&H P-value threshold for this comparison was 0.017.|ANCOVA|ANCOVA linear model adjusted for pre-intervention MBV.||Intention to treat Full Maximum Likelihood based comparisons of baseline covariate adjusted pre- to post-intervention MBV change, where the difference is between treatment combination #2 and treatment combination #1 (i.e. treatment combination # 2 - treatment combination #1).||0.090|-0.779|0.110
72578970|NCT03355469|144685290|SUPERIORITY||Mean Difference (Final Values)|-0.34||||0.145|TWO_SIDED|95.0|-0.818|0.137||Benjamini and Hochberg method was used to decrease the false discovery rate with an overall error rate of 0.05. The B\&H P-value threshold for this comparison was 0.033.|ANCOVA|ANCOVA linear model adjusted for pre-intervention MBV.||Intention to treat Full Maximum Likelihood based comparisons of baseline covariate adjusted pre- to post-intervention MBV change, where the difference is between treatment combination #2 and treatment combination #1 (i.e. treatment combination # 2 - treatment combination #1).||0.137|-0.818|0.145
72578971|NCT03355469|144685290|SUPERIORITY||Mean Difference (Final Values)|-0.114||||0.565|TWO_SIDED|95.0|-0.538|0.309||Benjamini and Hochberg method was used to decrease the false discovery rate with an overall error rate of 0.05. The B\&H P-value threshold for this comparison was 0.042.|ANCOVA|ANCOVA linear model adjusted for pre-intervention MBV.||Intention to treat Full Maximum Likelihood based comparisons of baseline covariate adjusted pre- to post-intervention MBV change, where the difference is between treatment combination #2 and treatment combination #1 (i.e. treatment combination # 2 - treatment combination #1).||0.309|-0.538|0.565
72578972|NCT03355469|144685290|SUPERIORITY||Mean Difference (Final Values)|-0.454||||0.11|TWO_SIDED|95.0|-1.025|0.116||Benjamini and Hochberg method was used to decrease the false discovery rate with an overall error rate of 0.05. The B\&H P-value threshold for this comparison was 0.025.|ANCOVA|ANCOVA linear model adjusted for pre-intervention MBV.||Intention to treat Full Maximum Likelihood based comparisons of baseline covariate adjusted pre- to post-intervention MBV change, where the difference is between treatment combination #2 and treatment combination #1 (i.e. treatment combination # 2 - treatment combination #1).||0.116|-1.025|0.110
72578973|NCT01708941|144685291|SUPERIORITY|||||||0.49|||||||Log Rank|||The primary comparison was ipilimumab + HDI versus ipilimumab alone, across ipilimumab dose (Arms A \& C versus Arms B \& D)||||0.490
72544296|NCT01360632|144618374|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.27||||0.0009|TWO_SIDED|95.0|-0.42|-0.11|||Cochran-Mantel-Haenszel|P-value and treatment difference (CI) are derived from CMH row mean score differ test controlling for study center.||Statistical analysis 1 at Week 10. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||-0.11|-0.42|0.0009
72544297|NCT01360632|144618374|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.24||||0.0019|TWO_SIDED|95.0|-0.38|-0.09|||Cochran-Mantel-Haenszel|P-value and treatment difference (CI) are derived from CMH row mean scores statistics controlling for study center||Statistical analysis 2 at Week 10. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||-0.09|-0.38|0.0019
72544298|NCT01360632|144618374|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.26||||0.0009|TWO_SIDED|95.0|-0.42|-0.11|||Cochran-Mantel-Haenszel|P-value and treatment difference (CI) are derived from CMH row mean score differ test controlling for study center||Statistical analysis 1 at Week 11. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||-0.11|-0.42|0.0009
72544299|NCT01360632|144618374|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.18||||0.0254|TWO_SIDED|95.0|-0.34|-0.02|||Cochran-Mantel-Haenszel|P-value and treatment difference (CI) are derived from CMH row mean score differ test controlling for study center.||Statistical analysis 2 at Week 11. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||-0.02|-0.34|0.0254
72544300|NCT01360632|144618374|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.25||||0.0035|TWO_SIDED|95.0|-0.41|-0.08|||Cochran-Mantel-Haenszel|P-value and treatment difference (CI) are derived from CMH row mean score differ test controlling for study center.||Statistical analysis 1 at Week 12. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||-0.08|-0.41|0.0035
72544301|NCT01360632|144618374|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.21||||0.0152|TWO_SIDED|95.0|-0.39|-0.04|||Cochran-Mantel-Haenszel|P-value and treatment difference (CI) are derived from CMH row mean score differ test controlling for study center.||Statistical analysis 2 at Week 12. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||-0.04|-0.39|0.0152
72544302|NCT01360632|144618374|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.25||||0.004|TWO_SIDED|95.0|-0.42|-0.08|||Cochran-Mantel-Haenszel|P-value and treatment difference (CI) are derived from CMH row mean score differ test controlling for study center.||Statistical analysis 1 at Week 13. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||-0.08|-0.42|0.004
72544303|NCT01360632|144618374|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.23||||0.013|TWO_SIDED|95.0|-0.42|-0.05|||Cochran-Mantel-Haenszel|P-value and treatment difference (CI) are derived from CMH row mean score differ test controlling for study center.||Statistical analysis 2 at Week 13. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||-0.05|-0.42|0.013
72544304|NCT01360632|144618374|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.16||||0.0755|TWO_SIDED|95.0|-0.33|0.02|||Cochran-Mantel-Haenszel|P-value and treatment difference (CI) are derived from CMH row mean score differ test controlling for study center.||Statistical analysis 1 at Week 14. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||0.02|-0.33|0.0755
72578974|NCT01708941|144685292|SUPERIORITY|||||||0.144|||||||Log Rank|||PFS comparison of higher dose ipilimumab versus lower dose ipilimumab (Arms A \& B versus Arms C \& D)||||0.144
72578975|NCT01708941|144685293|SUPERIORITY|||||||0.691|||||||Log Rank|||||||0.691
72578976|NCT01708941|144685294|SUPERIORITY|||||||0.868|||||||Log Rank|||Comparison of higher dose ipilimumab versus lower dose ipilimumab across HDI status (Arms A \& B versus Arms C \& D)||||0.868
72578977|NCT01575548|144685297|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.21|TWO_SIDED|95.0|0.54|1.29|||Log Rank|Stratified log rank test was used to compare DFS between the two arms.||||1.29|0.54|0.21
72578978|NCT03952585|144685312|NON_INFERIORITY|Estimated 9-month PFS = 96.5% and lower acceptable threshold = 91.8%, resulting in a non-inferiority margin of 4.7%. H0: HR = 2.4; alternative hypothesis (HA): HR=1.0. One-sided type I error rate of 10% (20% after Bonferroni adjustment for each experimental arm comparison), 80% power, 24 months of accrual with 1 year of additional follow-up, and 1% increasing yearly rate of drop-out up to 3%, a log rank test requires 22 events from 266 patients per comparison resulting in 133 patients per arm.|Hazard Ratio (HR)|7.42|||||ONE_SIDED|90.0||19.46|||||Reference level = Arm 1|The null hypothesis (H0) for each comparison in phase II will be rejected if the 90% upper confidence of the hazard ratio (HR) (experimental arm / standard arm) is less than HR=2.4.||19.46||
72578979|NCT03952585|144685312|NON_INFERIORITY|Estimated 9-month PFS = 96.5% and lower acceptable threshold = 91.8%, resulting in a non-inferiority margin of 4.7%. H0: HR = 2.4; alternative hypothesis (HA): HR=1.0. One-sided type I error rate of 10% (20% after Bonferroni adjustment for each experimental arm comparison), 80% power, 24 months of accrual with 1 year of additional follow-up, and 1% increasing yearly rate of drop-out up to 3%, a log rank test requires 22 events from 266 patients per comparison resulting in 133 patients per arm.|Hazard Ratio (HR)|5.55|||||ONE_SIDED|90.0||14.85|||||Reference level = Arm 1|The null hypothesis (H0) for each comparison in phase II will be rejected if the 90% upper confidence of the hazard ratio (HR) (experimental arm / standard arm) is less than HR=2.4.||14.85||
72578980|NCT03952585|144685315|SUPERIORITY||Hazard Ratio (HR)|20.56|||||TWO_SIDED|95.0|1.05|403.31|||||Cause-specific; reference level = Arm 1|||403.31|1.05|
72578981|NCT03952585|144685315|SUPERIORITY||Hazard Ratio (HR)|12.87|||||TWO_SIDED|95.0|0.58|287.93|||||Reference level = Arm 1|||287.93|0.58|
72578982|NCT03952585|144685316|SUPERIORITY||Cox Proportional Hazard|1.78|||||TWO_SIDED|95.0|0.34|9.46|||||Cause-specific; reference level = Arm 1|||9.46|0.34|
72578983|NCT03952585|144685316|SUPERIORITY||Cox Proportional Hazard|1.43|||||TWO_SIDED|95.0|0.24|8.45|||||Cause-specific; reference level = Arm 1|||8.45|0.24|
72578984|NCT03952585|144685317|SUPERIORITY||Hazard Ratio (HR)|5.58|||||TWO_SIDED|95.0|0.67|46.41|||||Reference level = Arm 1|||46.41|0.67|
72578985|NCT03952585|144685317|SUPERIORITY||Hazard Ratio (HR)|4.87|||||TWO_SIDED|95.0|0.57|41.74|||||Reference level = Arm 1|||41.74|0.57|
72578986|NCT02048813|144685329|SUPERIORITY||Hazard Ratio (HR)|0.35|||<|0.001|TWO_SIDED|95.0|0.22|0.56|||Log Rank|||||0.56|0.22|<.001
72578987|NCT02048813|144685330|SUPERIORITY||Hazard Ratio (HR)|0.17|||<|0.001|TWO_SIDED|95.0|0.05|0.54|||Log Rank|||||0.54|0.05|<.001
72578988|NCT01708954|144685341|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.37|||||TWO_SIDED|80.0|0.25|0.53|||||Hazard ratio of Arm C/Arm A|||0.53|0.25|
72578989|NCT01708954|144685341|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.39|||||TWO_SIDED|80.0|0.27|0.55|||||Hazard ratio of Arm B/Arm A|||0.55|0.27|
72578990|NCT03631199|144685376|EQUIVALENCE|Nominal p-values are presented without any statistical inference since there was no adjustment for multiplicity.|Hazard Ratio (HR)|0.62||||0.00164|TWO_SIDED|95.0|0.45|0.86|||Log Rank|||Chest pain||0.86|0.45|0.00164
72421532|NCT01181726|144354215|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|97.6|||||TWO_SIDED|90.0|94.05|101.3|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||101.30|94.05|
72544305|NCT01360632|144618374|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2||||0.0527|TWO_SIDED|95.0|-0.39|0.0|||Cochran-Mantel-Haenszel|P-value and treatment difference (CI) are derived from CMH row mean score differ test controlling for study center||Statistical analysis 2 at Week 14. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||0|-0.39|0.0527
72544306|NCT01360632|144618375|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.14||||0.0275|TWO_SIDED|95.0|-0.26|-0.01|||Cochran-Mantel-Haenszel|P-value and treatment difference (CI) are derived from CMH row mean score differ test controlling for study center.||Statistical analysis 1 at Week 9. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.||-0.01|-0.26|0.0275
72544307|NCT01360632|144618375|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.09||||0.1583|TWO_SIDED|95.0|-0.22|0.04|||Cochran-Mantel-Haenszel|P-value and treatment difference (CI) are derived from CMH row mean score differ test controlling for study center.||Statistical analysis 2 at Week 9. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.||0.04|-0.22|0.1583
72544308|NCT01360632|144618375|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.25||||0.0021|TWO_SIDED|95.0|-0.41|-0.09|||Cochran-Mantel-Haenszel|P-value and treatment difference (CI) are derived from CMH row mean score differ test controlling for study center.||Statistical analysis 1 at Week 10. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.||-0.09|-0.41|0.0021
72544309|NCT01360632|144618375|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.24||||0.0018|TWO_SIDED|95.0|-0.4|-0.09|||Cochran-Mantel-Haenszel|P-value and treatment difference (CI) are derived from CMH row mean score differ test controlling for study center.||Statistical analysis 2 at Week 10. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.||-0.09|-0.4|0.0018
72544310|NCT01360632|144618375|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.27||||0.0011|TWO_SIDED|95.0|-0.43|-0.11|||Cochran-Mantel-Haenszel|P-value and treatment difference (CI) are derived from CMH row mean score differ test controlling for study center.||Statistical analysis 1 at Week 11. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.||-0.11|-0.43|0.0011
72578991|NCT03631199|144685376|EQUIVALENCE|Nominal p-values are presented without any statistical inference since there was no adjustment for multiplicity.|Hazard Ratio (HR)|0.59||||0.00069|TWO_SIDED|95.0|0.43|0.82|||Log Rank|||Cough||0.82|0.43|0.00069
72578992|NCT03631199|144685376|EQUIVALENCE|Nominal p-values are presented without any statistical inference since there was no adjustment for multiplicity.|Hazard Ratio (HR)|0.66||||0.00045|TWO_SIDED|95.0|0.51|0.84|||Log Rank|||Dyspnea||0.84|0.51|0.00045
72578993|NCT03631199|144685377|EQUIVALENCE|Nominal p-values are presented without any statistical inference since there was no adjustment for multiplicity.|Hazard Ratio (HR)|0.86||||0.113|TWO_SIDED|95.0|0.66|1.1|||Log Rank|||Quality of Life||1.10|0.66|0.113
72578994|NCT03631199|144685377|EQUIVALENCE|Nominal p-values are presented without any statistical inference since there was no adjustment for multiplicity.|Hazard Ratio (HR)|0.68||||0.00433|TWO_SIDED|95.0|0.51|0.91|||Log Rank|||Shortness of Breath||0.91|0.51|0.00433
72578995|NCT03631199|144685377|EQUIVALENCE|Nominal p-values are presented without any statistical inference since there was no adjustment for multiplicity.|Hazard Ratio (HR)|0.93||||0.294|TWO_SIDED|95.0|0.72|1.2|||Log Rank|||Pain||1.20|0.72|0.294
72578996|NCT03651700|144685406|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|||||||<.05
72544311|NCT01360632|144618375|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.19||||0.0235|TWO_SIDED|95.0|-0.36|-0.03|||Cochran-Mantel-Haenszel|P-value and treatment difference (CI) are derived from CMH row mean score differ test controlling for study center.||Statistical analysis 2 at Week 11. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.||-0.03|-0.36|0.0235
72578997|NCT03651700|144685407|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|||||||<.05
72578998|NCT03698019|144685425|SUPERIORITY||Hazard Ratio (HR)|0.64||||0.004|TWO_SIDED||||||Log Rank|||||||0.004
72578999|NCT00588770|144685430|SUPERIORITY|||||||0.22||||||The P value was based on stratified log rank test, stratified by choice of chemotherapy combination, performance status, weight loss in the last 6 months, and prior radiation of the head and neck.|Log Rank|||The study hypothesis is that the addition of bevacizumab will improve the median survival by 35% from 8.5 months (based on E1395 and E5397) to 11.5 months.||||0.22
72579000|NCT01856192|144685435|SUPERIORITY|||||||0.03|||||||Log Rank|Stratified log rank test||||||0.03
72579001|NCT04976621|144685453|OTHER|Because this was a feasibility study, we did not compute inferential statistics and did not include a power calculation.||||||||||||Because this was a feasibility study, inferential statistics were not computed.||||This feasibility study assessed preliminary evidence of treatment response. We have reported only descriptive statistics for quantitative findings. We have not reported inferential statistics, in keeping with the purpose of the VA SPiRE grant mechanism through which the study was funded. We assessed change in participant response by comparing the mean change in the outcome from baseline to follow-up in Group 1 (BA) and Group 2 (TAU). We inspected trends and directions of change in both groups.|Because this is a feasibility study, inferential statistics were not computed. We examined the trends and direction of change in the baseline mean score and follow-up mean score between the two groups.|||
72579002|NCT04976621|144685454|OTHER|||||||||||||||||This feasibility study assessed preliminary evidence of treatment response. We have reported only descriptive statistics for quantitative findings. We have not reported inferential statistics, in keeping with the purpose of the VA SPiRE grant mechanism through which the study was funded. We assessed change in participant response by comparing the mean change in the outcome from baseline to follow-up in Group 1 (BA) and Group 2 (TAU). We inspected trends and directions of change in both groups.|Because this is a feasibility study, inferential statistics were not computed. We examined the trends and direction of change in the baseline mean score and follow-up mean score between the two groups.|||
72579003|NCT04976621|144685455|OTHER|||||||||||||||||This feasibility study assessed preliminary evidence of treatment response. We have reported only descriptive statistics for quantitative findings. We have not reported inferential statistics, in keeping with the purpose of the VA SPiRE grant mechanism through which the study was funded. We assessed change in participant response by comparing the mean change in the outcome from baseline to follow-up in Group 1 (BA) and Group 2 (TAU). We inspected trends and directions of change in both groups.|Because this is a feasibility study, inferential statistics were not computed. We examined the trends and direction of change in the baseline mean score and follow-up mean score between the two groups.|||
72579004|NCT04976621|144685456|OTHER||||||||||||||||||This analysis involved examination of the percentage that scored above a mean of 3.0 (our criteria for acceptability in this feasibility study).|||
72579005|NCT04976621|144685457|OTHER|||||||||||||||||Descriptive statistics are used to describe acceptability/satisfaction for those who received the BA intervention. This tool is completed after the last intervention session when the qualitative interview is also conducted.|Descriptive statistics are used in this feasibility study. We are not using inferential statistics to test for statistical significance.|||
72579006|NCT04976621|144685458|OTHER||||||||||||||||||Descriptive statistics are used to describe recruitment.|||
72544312|NCT01360632|144618375|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.27||||0.0021|TWO_SIDED|95.0|-0.44|-0.1|||Cochran-Mantel-Haenszel|P-value and treatment difference (CI) are derived from CMH row mean score differ test controlling for study center.||Statistical analysis 1 at Week 12. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.||-0.10|-0.44|0.0021
72544313|NCT01360632|144618375|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.24||||0.0111|TWO_SIDED|95.0|-0.42|-0.05|||Cochran-Mantel-Haenszel|P-value and treatment difference (CI) are derived from CMH row mean score differ test controlling for study center.||Statistical analysis 2 at Week 12. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.||-0.05|-0.42|0.0111
72544314|NCT01360632|144618375|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.26||||0.003|TWO_SIDED|95.0|-0.44|-0.09|||Cochran-Mantel-Haenszel|P-value and treatment difference (CI) are derived from CMH row mean score differ test controlling for study center.||Statistical analysis 1 at Week 13. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.||-0.09|-0.44|0.0030
72544315|NCT01360632|144618375|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.28||||0.0046|TWO_SIDED|95.0|-0.47|-0.09|||Cochran-Mantel-Haenszel|P-value and treatment difference (CI) are derived from CMH row mean score differ test controlling for study center.||Statistical analysis 2 at Week 13. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.||-0.09|-0.47|0.0046
72544316|NCT01360632|144618375|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.21||||0.0237|TWO_SIDED|95.0|-0.39|-0.03|||Cochran-Mantel-Haenszel|P-value and treatment difference (CI) are derived from CMH row mean score differ test controlling for study center.||Statistical analysis 1 at Week 14. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.||-0.03|-0.39|0.0237
72544317|NCT01360632|144618375|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.25||||0.0171|TWO_SIDED|95.0|-0.45|-0.04|||Cochran-Mantel-Haenszel|P-value and treatment difference (CI) are derived from CMH row mean score differ test controlling for study center.||Statistical analysis 2 at Week 14. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.||-0.04|-0.45|0.0171
72544318|NCT01360632|144618376|SUPERIORITY_OR_OTHER||Ratio of response rate|1.37||||0.5279|TWO_SIDED|95.0|0.51|3.68|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 1 at Week 9. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||3.68|0.51|0.5279
72544319|NCT01360632|144618376|SUPERIORITY_OR_OTHER||Ratio of response rate|0.13||||0.0141|TWO_SIDED|95.0|0.02|0.94|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 2 at Week 9. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||0.94|0.02|0.0141
72544320|NCT01360632|144618376|SUPERIORITY_OR_OTHER||Ratio of response rate|1.92||||0.0484|TWO_SIDED|95.0|0.99|3.72|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 1 at Week 10. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||3.72|0.99|0.0484
72544321|NCT01360632|144618376|SUPERIORITY_OR_OTHER||Ratio of response rate|1.23||||0.5813|TWO_SIDED|95.0|0.6|2.5|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 2 at Week 10. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||2.50|0.60|0.5813
72544322|NCT01360632|144618376|SUPERIORITY_OR_OTHER||Ratio of response rate|1.51||||0.1236|TWO_SIDED|95.0|0.9|2.54|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 1 at Week 11. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||2.54|0.90|0.1236
72544323|NCT01360632|144618376|SUPERIORITY_OR_OTHER||Ratio of response rate|1.21||||0.4998|TWO_SIDED|95.0|0.7|2.1|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 2 at Week 11. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||2.10|0.70|0.4998
72579007|NCT04976621|144685459|OTHER||||||||||||||||||One measure of retention was the percent in each group who completed the study, meaning completed the Time 2 follow-up interview (that occurred 3-4 months after the baseline interview). Another measure of retention was the percent in the treatment group that completed four or more treatment sessions.|||
72579008|NCT04976621|144685460|OTHER||||||||||||||||||For each of five participants who received the intervention, we reviewed a transcript of 1 intervention session for treatment fidelity. The criterion is that no more than 15% of sessions observed or audiotaped will have a mean less than 2.0.|||
72579009|NCT05992623|144685461|SUPERIORITY|||||||0.565|||||||Chi-squared|||||||0.565
72579010|NCT05992623|144685462|SUPERIORITY|||||||0.617|||||||Chi-squared|||||||0.617
72579011|NCT05992623|144685463|SUPERIORITY||Mean Difference (Final Values)|0.04|||<|0.05|TWO_SIDED||||||Chi-squared|||||||<0.05
72544324|NCT01360632|144618376|SUPERIORITY_OR_OTHER||Ratio of response rate|1.64||||0.0365|TWO_SIDED|95.0|1.03|2.61|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 1 at Week 12. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||2.61|1.03|0.0365
72544325|NCT01360632|144618376|SUPERIORITY_OR_OTHER||Ratio of response rate|1.52||||0.0822|TWO_SIDED|95.0|0.95|2.43|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 2 at Week 12. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||2.43|0.95|0.0822
72544326|NCT01360632|144618376|SUPERIORITY_OR_OTHER||Ratio of response rate|1.19||||0.4049|TWO_SIDED|95.0|0.79|1.78|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 1 at Week 13. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||1.78|0.79|0.4049
72544327|NCT01360632|144618376|SUPERIORITY_OR_OTHER||Ratio of response rate|1.23||||0.2951|TWO_SIDED|95.0|0.84|1.8|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 2 at Week 13. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||1.80|0.84|0.2951
72544328|NCT01360632|144618376|SUPERIORITY_OR_OTHER||Ratio of response rate|1.53||||0.0248|TWO_SIDED|95.0|1.06|2.2|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 1 at Week 14. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||2.20|1.06|0.0248
72544329|NCT01360632|144618376|SUPERIORITY_OR_OTHER||Ratio of response rate|1.51||||0.0326|TWO_SIDED|95.0|1.03|2.21|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 2 at Week 14. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||2.21|1.03|0.0326
72544330|NCT01360632|144618377|SUPERIORITY_OR_OTHER||Ratio of response rate|0.87||||0.7993|TWO_SIDED|95.0|0.3|2.55|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 1 at Week 9. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.||2.55|0.30|0.7993
72544331|NCT01360632|144618377|SUPERIORITY_OR_OTHER||Ratio of response rate|0.11||||0.0118|TWO_SIDED|95.0|0.01|0.93|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 2 at Week 9. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.||0.93|0.01|0.0118
72544332|NCT01360632|144618377|SUPERIORITY_OR_OTHER||Ratio of response rate|1.5||||0.2825|TWO_SIDED|95.0|0.71|3.16|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 1 at Week 10. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.||3.16|0.71|0.2825
72579012|NCT05219448|144685500|SUPERIORITY||Mean Difference (Final Values)|7.4||||0.17|TWO_SIDED|95.0|-3.2|18.0||Unadjusted p value presented. The a priori threshold for statistical significance is 0.05.|Regression, Linear|||Null hypothesis: The change in added sugar intake from baseline to 6-months will be the same when compared to children in the no-treatment control arm (measured through hair biomarker).||18.0|-3.2|0.17
72579013|NCT05219448|144685501|SUPERIORITY||Mean Difference (Final Values)|-5.1||||0.6|TWO_SIDED|95.0|-24.3|14.0||Unadjusted P-value. The threshold for significance is 0.05.|Regression, Linear|||Null hypothesis: The change in added sugar intake from baseline to 6-months will be the same for caregivers in community A arm when compared to caregivers in the no-treatment control arm (measured through hair biomarker).||14.0|-24.3|0.60
72579014|NCT05219448|144685501|SUPERIORITY||Mean Difference (Final Values)|-24.7||||0.013|TWO_SIDED|95.0|-44.1|-5.4||The P-value is unadjusted. The threshold for significance is 0.05.|Regression, Linear|||Null hypothesis: The change in added sugar intake from baseline to 6-months will be the same for caregivers in community B when compared to caregivers in the no-treatment control arm (measured through hair biomarker).||-5.4|-44.1|0.013
72579015|NCT04739800|144685637|EQUIVALENCE|This is the Hazard Ratio of Group 2 compared to Group 1.|Hazard Ratio (HR)|1.0|||||TWO_SIDED|95.0|0.44|2.31|||||This is the Hazard Ratio of Group 2 compared to Group 1.|||2.31|0.44|
72579016|NCT04739800|144685637|EQUIVALENCE|This is the Hazard Ratio of Group 3 compared to Group 1.|Hazard Ratio (HR)|1.21|||||TWO_SIDED|95.0|0.52|2.84|||||This is the Hazard Ratio of Group 3 compared to Group 1.|||2.84|0.52|
72579017|NCT04739800|144685637|EQUIVALENCE|This is the Hazard Ratio of Group 4 compared to Group 1.|Hazard Ratio (HR)|1.34|||||TWO_SIDED|95.0|0.58|3.08|||||||This is the Hazard Ratio of Group 4 compared to Group 1.|3.08|0.58|
72579018|NCT04739800|144685640|EQUIVALENCE|This is the Hazard Ratio of Group 2 compared to Group 1.|Hazard Ratio (HR)|1.41|||||TWO_SIDED|95.0|0.44|4.47|||||This is the Hazard Ratio for Group 2 compared to Group 1.|||4.47|0.44|
72579019|NCT04739800|144685640|EQUIVALENCE|This is the Hazard Ratio of Group 3 compared to Group 1.|Hazard Ratio (HR)|1.3|||||TWO_SIDED|95.0|0.4|4.19|||||This is the Hazard Ratio of Group 3 compared to Group 1.|||4.19|0.40|
72544333|NCT01360632|144618377|SUPERIORITY_OR_OTHER||Ratio of response rate|1.2||||0.6375|TWO_SIDED|95.0|0.58|2.5|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 2 at Week 10. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.||2.50|0.58|0.6375
72579020|NCT04739800|144685640|EQUIVALENCE|This is the Hazard Ratio of Group 4 compared to Group 1.|Hazard Ratio (HR)|1.34|||||TWO_SIDED|95.0|0.58|3.08|||||This is the Hazard Ratio of Group 4 compared to Group 1.|||3.08|0.58|
72579021|NCT01906515|144685648|SUPERIORITY_OR_OTHER||||||<|0.01||95.0|||||t-test, 2 sided|||||||<0.01
72579022|NCT01906515|144685649|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
72544334|NCT01360632|144618377|SUPERIORITY_OR_OTHER||Ratio of response rate|1.62||||0.0923|TWO_SIDED|95.0|0.92|2.82|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 1 at Week 11. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.||2.82|0.92|0.0923
72544335|NCT01360632|144618377|SUPERIORITY_OR_OTHER||Ratio of response rate|1.29||||0.3812|TWO_SIDED|95.0|0.73|2.3|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 2 at Week 11. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.||2.30|0.73|0.3812
72544336|NCT01360632|144618377|SUPERIORITY_OR_OTHER||Ratio of response rate|1.63||||0.0464|TWO_SIDED|95.0|1.0|2.65|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 1 at Week 12. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.||2.65|1.00|0.0464
72544337|NCT01360632|144618377|SUPERIORITY_OR_OTHER||Ratio of response rate|1.62||||0.049|TWO_SIDED|95.0|1.0|2.64|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 2 at Week 12. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.||2.64|1.00|0.0490
72544338|NCT01360632|144618377|SUPERIORITY_OR_OTHER||Ratio of response rate|1.32||||0.2124|TWO_SIDED|95.0|0.85|2.06|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 1 at Week 13. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.||2.06|0.85|0.2124
72544339|NCT01360632|144618377|SUPERIORITY_OR_OTHER||Ratio of response rate|1.41||||0.1078|TWO_SIDED|95.0|0.93|2.14|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 2 at Week 13. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.||2.14|0.93|0.1078
72544340|NCT01360632|144618377|SUPERIORITY_OR_OTHER||Ratio of response rate|1.69||||0.0094|TWO_SIDED|95.0|1.14|2.5|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 1 at Week 14. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.||2.50|1.14|0.0094
72544341|NCT01360632|144618377|SUPERIORITY_OR_OTHER||Ratio of response rate|1.65||||0.0162|TWO_SIDED|95.0|1.09|2.5|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 2 at Week 14. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.||2.50|1.09|0.0162
72544342|NCT01360632|144618378|SUPERIORITY_OR_OTHER||Ratio of remission rate|1.03||||0.9498|TWO_SIDED|95.0|0.37|2.9|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 1 at Week 9. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||2.90|0.37|0.9498
72544343|NCT01360632|144618378|SUPERIORITY_OR_OTHER||Ratio of response rate|0.13||||0.0141|TWO_SIDED|95.0|0.02|0.94|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 2 at Week 9. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||0.94|0.02|0.0141
72544344|NCT01360632|144618378|SUPERIORITY_OR_OTHER||Ratio of response rate|0.93||||0.8609|TWO_SIDED|95.0|0.4|2.17|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 1 at Week 10. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||2.17|0.40|0.8609
72544345|NCT01360632|144618378|SUPERIORITY_OR_OTHER||Ratio of response rate|0.59||||0.2846|TWO_SIDED|95.0|0.22|1.54|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 2 at Week 10. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||1.54|0.22|0.2846
72544346|NCT01360632|144618378|SUPERIORITY_OR_OTHER||Ratio of response rate|1.5||||0.248|TWO_SIDED|95.0|0.75|2.99|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 1 at Week 11. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||2.99|0.75|0.2480
72579023|NCT01377012|144685667|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.21||||0.0004|TWO_SIDED|95.0|1.4|3.4|||Regression, Logistic|||||3.4|1.4|0.0004
72579024|NCT01377012|144685667|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.21||||0.0004|TWO_SIDED|95.0|1.4|3.4|||Regression, Logistic|||||3.4|1.4|0.0004
72579025|NCT06360081|144685677|EQUIVALENCE|The assessment of bioequivalence was based on two-sided 90% CIs for the ratios of the geometric means (gMean) (T/R) using an acceptance range of 80.0 to 125.0%.|Ratio of adjusted geometric means (T/R)|99.89|||<|0.0001|TWO_SIDED|90.0|97.08|102.78||p-value was calculated for ratios outside the 80.0 to 125.0% interval.|ANOVA||Ratio as percentage \[%\] Intra-individual geometric coefficient of variation (gCV) = 9.0%.|PK endpoints were back transformed to the original scale to provide the point estimate and 90% confidence intervals (CIs) for each endpoint. The model included effects accounting for variation in sequence, subjects within sequences, period, and treatment. The effect 'subjects within sequences' was considered as random, whereas the others were considered as fixed. Confidence intervals were calculated based on the residual error from the ANOVA.||102.78|97.08|<0.0001
72579026|NCT06360081|144685678|EQUIVALENCE|The assessment of bioequivalence was based on two-sided 90% CIs for the ratios of the geometric means (gMean) (T/R) using an acceptance range of 80.0 to 125.0%.|Ratio of adjusted geometric means (T/R)|100.83|||<|0.0001|TWO_SIDED|90.0|96.43|105.44||p-value was calculated for ratios outside the 80.0 to 125.0% interval.|ANOVA||Ratio as percentage \[%\] Intra-individual geometric coefficient of variation (gCV) = 14.2%.|PK endpoints were back transformed to the original scale to provide the point estimate and 90% confidence intervals (CIs) for each endpoint. The model included effects accounting for variation in sequence, subjects within sequences, period, and treatment. The effect 'subjects within sequences' was considered as random, whereas the others were considered as fixed. Confidence intervals were calculated based on the residual error from the ANOVA.||105.44|96.43|<0.0001
72579027|NCT04140032|144685687|SUPERIORITY||Difference between groups in change in B|-0.18|STANDARD_DEVIATION|0.06||0.003|TWO_SIDED|95.0|-0.31|-0.06|||Mixed Models Analysis|p \< 0.05 considered significant||||-0.06|-0.31|0.003
72579028|NCT04140032|144685688|SUPERIORITY||Odds ratio for difference between groups|1.29||||0.7|TWO_SIDED|95.0|0.034|4.91|||Mixed Models Analysis|p \< 0.05 considered significant|Reported dispersion parameter is standard error of log(OR)|||4.91|.034|0.7
72579029|NCT04140032|144685689|SUPERIORITY||Difference between groups in change in f|-0.2|STANDARD_DEVIATION|0.19||0.3|TWO_SIDED|95.0|-0.58|0.17|||Mixed Models Analysis|||||0.17|-0.58|0.3
72579030|NCT04140032|144685693|SUPERIORITY||Odds ratio for difference between groups|1.1|STANDARD_ERROR_OF_MEAN|0.35||0.8|TWO_SIDED|95.0|0.56|2.16|||Mixed Models Analysis|p \< 0.05 considered significant|Reported dispersion parameter is standard error of log(OR)|||2.16|0.56|0.8
72579031|NCT04140032|144685693|SUPERIORITY||Odds ratio for difference between groups|1.1||||0.8|TWO_SIDED|95.0|0.56|2.16|||Mixed Models Analysis|p \< 0.05 considered significant|Reported dispersion parameter is standard error of log(OR)|||2.16|0.56|0.8
72579032|NCT02276807|144685745|SUPERIORITY||Mean Difference (Final Values)|0.345|||<|0.05|TWO_SIDED||||||ANOVA|2 (Condition: TAU, BA-PC) X 2 (Time: Baseline vs. Week 12) repeated measures ANOVA||||||<0.05
72579033|NCT02276807|144685746|SUPERIORITY||Mean Difference (Final Values)|0.046|||<|0.05|TWO_SIDED||||||ANOVA|2 (Condition: TAU vs. BA-PC) X 2 (time: Baseline vs. week 12) repeated measures ANOVA||||||<0.05
72579034|NCT02276807|144685747|SUPERIORITY||Mean Difference (Final Values)|0.666|||<|0.05|TWO_SIDED||||||ANOVA|2 (Condition: TAU, BA-PC) X 2 (Time: Baseline, Week 12) Repeated Measures ANOVA||||||<0.05
72579035|NCT02276807|144685748|SUPERIORITY||Mean Difference (Final Values)|0.014|||<|0.05|TWO_SIDED||||||ANOVA|2 (Condition: TAU vs. BA-PC) X 2 (Time: Baseline, Week 12) Repeated Measures ANOVA||||||<0.05
72579036|NCT02276807|144685749|SUPERIORITY||Mean Difference (Final Values)|0.722|||<|0.05|TWO_SIDED||||||ANOVA|2 (Condition: TAU vs. BA-PC) X 2 (Time: Baseline vs. Week 12) Repeated Measures ANOVA||||||<0.05
72579037|NCT03971474|144685750|SUPERIORITY||Hazard Ratio (HR)|0.69||||0.05|TWO_SIDED|80.0|0.51|0.92||If either P value from the two tests (standard stratified log-rank and weighted log-rank) was \< 0.0972, the study would be considered to have rejected the null at the one-sided 10% level.|Log Rank|Testing was performed using a standard stratified log-rank test.|Treatment effects comparing the RP arm to the SOC arm were summarized using a Cox proportional hazards model including the stratification factors (PD-L1 status and histology) and 80% CIs.|Comparison of OS was performed using a standard stratified log-rank test and a weighted log-rank test. The study had 90% power to detect the scenario with overlapping curves up to 3 months and a hazard ratio of 0.5 after 3 months, assuming exponentially distributed survival times, a median OS of 10.5 months in the SOC arm, and uniform accrual over 21-24 months. This analysis reports the standard stratified log-rank test.||0.92|0.51|0.05
72579038|NCT03971474|144685750|SUPERIORITY|||||||0.15||||||If either p-value from the two tests (standard stratified log-rank and weighted log-rank) was \< 0.0972, the study would be considered to have rejected the null at the one-sided 10% level.|Log Rank|||Comparison of OS was performed using a standard stratified log-rank test and a weighted log-rank test. The study had 90% power to detect the scenario with overlapping curves up to 3 months and a hazard ratio of 0.5 after 3 months, assuming exponentially distributed survival times, a median OS of 10.5 months in the SOC arm, and uniform accrual over 21-24 months. This analysis reports the weighted log-rank test.||||0.15
72579039|NCT03971474|144685751|SUPERIORITY|||||||0.19||||||Proportions were compared using a chi-squared test at the one-sided 5% level.|Chi-squared|||||||0.19
72579040|NCT03971474|144685752|SUPERIORITY|||||||0.38||||||Proportions were compared using a chi-squared test at the one-sided 5% level.|Chi-squared|||||||0.38
72579041|NCT03971474|144685755|SUPERIORITY||Hazard Ratio (HR)|0.86||||0.25|TWO_SIDED|80.0|0.66|1.14|||Log Rank|Testing was performed using a standard stratified log-rank test.|Treatment effects comparing the RP arm to the SOC arm were summarized using a Cox proportional hazards model including the stratification factors (PD-L1 status and histology) and 80% CIs.|Comparison of IA-PFS was performed using a standard stratified log-rank test and a weighted log-rank test with weights equal to 1-S(t), where S(t) is the pooled survival estimate at time t (G\[rho=0, gamma=1\]). The weighted test weights later events over earlier events and has more power than the standard log-rank test under a delayed separation in the curves. This analysis reports the standard stratified log-rank test.||1.14|0.66|0.25
72579042|NCT03971474|144685755|SUPERIORITY|||||||0.14|||||||Log Rank|Testing was performed using a weighted log-rank test.||Comparison of IA-PFS between the RP and SOC arms was performed using a standard stratified log-rank test and a weighted log-rank test with weights equal to 1-S(t), where S(t) is the pooled survival estimate at time t (G\[rho=0, gamma=1\]). The weighted test weights later events over earlier events and has more power than the standard log-rank test under a delayed separation in the curves. This analysis reports the weighted log-rank test.||||0.14
72579043|NCT03971474|144685756|SUPERIORITY||Hazard Ratio (HR)|0.74||||0.16|TWO_SIDED|80.0|0.5|1.1||One-sided p-values were calculated using a standard log-rank test.|Log Rank||Treatment effects comparing the RP arm to the SOC arm were summarized using a Cox proportional hazards model and 80% CIs.|This analysis includes the results for the PD-L1 \< 1% subgroup.||1.10|0.50|0.16
72579044|NCT03971474|144685756|SUPERIORITY||Hazard Ratio (HR)|0.66||||0.08|TWO_SIDED|80.0|0.45|0.97||One-sided p-values were calculated using a standard log-rank test.|Log Rank||Treatment effects comparing the RP arm to the SOC arm were summarized using a Cox proportional hazards model and 80% CIs.|This analysis includes the results for the PD-L1 \>= 1% subgroup.||0.97|0.45|0.08
72579045|NCT03971474|144685756|SUPERIORITY||Hazard Ratio (HR)|0.43||||0.005|TWO_SIDED|80.0|0.28|0.65||One-sided p-values were calculated using a standard log-rank test.|Log Rank||Treatment effects comparing the RP arm to the SOC arm were summarized using a Cox proportional hazards model and 80% CIs.|This analysis includes the results for the squamous histology subgroup.||0.65|0.28|0.005
72579046|NCT03971474|144685756|SUPERIORITY||Hazard Ratio (HR)|0.95||||0.43|TWO_SIDED|80.0|0.67|1.35||One-sided p-values were calculated using a standard log-rank test.|Log Rank||Treatment effects comparing the RP arm to the SOC arm were summarized using a Cox proportional hazards model and 80% CIs.|This analysis includes the results for the non-squamous histology subgroup.||1.35|0.67|0.43
72579047|NCT03971474|144685757|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.28|TWO_SIDED|80.0|0.58|1.22||One-sided p-values were calculated using a standard log-rank test.|Log Rank||Treatment effects comparing the RP arm to the SOC arm were summarized using a Cox proportional hazards model and 80% CIs.|This analysis includes the results for the PD-L1 \< 1% subgroup.||1.22|0.58|0.28
72579048|NCT03971474|144685757|SUPERIORITY||Hazard Ratio (HR)|0.67||||0.07|TWO_SIDED|80.0|0.48|0.95||One-sided p-values were calculated using a standard log-rank test.|Log Rank||Treatment effects comparing the RP arm to the SOC arm were summarized using a Cox proportional hazards model and 80% CIs.|This analysis includes the results for the PD-L1 \>= 1% subgroup.||0.95|0.48|0.07
72579049|NCT03971474|144685757|SUPERIORITY||Hazard Ratio (HR)|0.55||||0.02|TWO_SIDED|80.0|0.38|0.8||One-sided p-values were calculated using a standard log-rank test.|Log Rank||Treatment effects comparing the RP arm to the SOC arm were summarized using a Cox proportional hazards model and 80% CIs.|This analysis includes the results for the squamous histology subgroup.||0.80|0.38|0.02
72579050|NCT03971474|144685757|SUPERIORITY||Hazard Ratio (HR)|0.95||||0.41|TWO_SIDED|80.0|0.69|1.29||One-sided p-values were calculated using a standard log-rank test.|Log Rank||Treatment effects comparing the RP arm to the SOC arm were summarized using a Cox proportional hazards model and 80% CIs.|This analysis includes the results for the non-squamous histology subgroup.||1.29|0.69|0.41
72579051|NCT01937871|144685776|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.41|||||TWO_SIDED|95.0|-2.25|-0.57||||||||-0.57|-2.25|
72579052|NCT01937871|144685780|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.85|||||TWO_SIDED|95.0|-1.87|0.18||||||||0.18|-1.87|
72579053|NCT01565356|144685843|SUPERIORITY_OR_OTHER||Kappa statistic|1.0|||||TWO_SIDED|95.0|1.0|1.0||||||Cohen's (simple) kappa statistic||1.00|1.00|
72544347|NCT01360632|144618378|SUPERIORITY_OR_OTHER||Ratio of response rate|1.13||||0.7513|TWO_SIDED|95.0|0.54|2.37|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 2 at Week 11. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||2.37|0.54|0.7513
72544348|NCT01360632|144618378|SUPERIORITY_OR_OTHER||Ratio of response rate|1.82||||0.0554|TWO_SIDED|95.0|0.99|3.35|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 1 at Week 12. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||3.35|0.99|0.0554
72544349|NCT01360632|144618378|SUPERIORITY_OR_OTHER||Ratio of response rate|1.48||||0.2409|TWO_SIDED|95.0|0.76|2.87|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 2 at Week 12. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||2.87|0.76|0.2409
72544350|NCT01360632|144618378|SUPERIORITY_OR_OTHER||Ratio of response rate|1.18||||0.5538|TWO_SIDED|95.0|0.69|2.02|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 1 at Week 13. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||2.02|0.69|0.5538
72544351|NCT01360632|144618378|SUPERIORITY_OR_OTHER||Ratio of response rate|1.44||||0.1743|TWO_SIDED|95.0|0.85|2.41|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 2 at Week 13. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||2.41|0.85|0.1743
72544352|NCT01360632|144618378|SUPERIORITY_OR_OTHER||Ratio of response rate|1.3||||0.2843|TWO_SIDED|95.0|0.81|2.07|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 1 at Week 14. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||2.07|0.81|0.2843
72544353|NCT01360632|144618378|SUPERIORITY_OR_OTHER||Ratio of response rate|1.19||||0.464|TWO_SIDED|95.0|0.74|1.92|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 2 at Week 14. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||1.92|0.74|0.4640
72544354|NCT01360632|144618379|SUPERIORITY_OR_OTHER||Ratio of response rate|0.6||||0.3867|TWO_SIDED|95.0|0.18|1.97|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 1 at Week 9. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.||1.97|0.18|0.3867
72544355|NCT01360632|144618379|SUPERIORITY_OR_OTHER||Ratio of response rate|0.11||||0.0118|TWO_SIDED|95.0|0.01|0.93|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 2 at Week 9. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.||0.93|0.01|0.0118
72544356|NCT01360632|144618379|SUPERIORITY_OR_OTHER||Ratio of response rate|0.59||||0.32|TWO_SIDED|95.0|0.21|1.66|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 1 at Week 10. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.||1.66|0.21|0.3200
72544357|NCT01360632|144618379|SUPERIORITY_OR_OTHER||Ratio of response rate|0.6||||0.3266|TWO_SIDED|95.0|0.23|1.62|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 2 at Week 10. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.||1.62|0.23|0.3266
72544358|NCT01360632|144618379|SUPERIORITY_OR_OTHER||Ratio of response rate|1.47||||0.3027|TWO_SIDED|95.0|0.7|3.1|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 1 at Week 11 All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.||3.10|0.70|0.3027
72544359|NCT01360632|144618379|SUPERIORITY_OR_OTHER||Ratio of response rate|1.17||||0.696|TWO_SIDED|95.0|0.54|2.52|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 2 at Week 11 All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.||2.52|0.54|0.6960
72544360|NCT01360632|144618379|SUPERIORITY_OR_OTHER||Ratio of response rate|1.62||||0.1368|TWO_SIDED|95.0|0.86|3.07||CMH general association test controlling for trial site|Cochran-Mantel-Haenszel|||Statistical analysis 1 at Week 12 All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.||3.07|0.86|0.1368
72544361|NCT01360632|144618379|SUPERIORITY_OR_OTHER||Ratio of response rate|1.48||||0.2387|TWO_SIDED|95.0|0.76|2.89|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 2 at Week 12. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.||2.89|0.76|0.2387
72544362|NCT01360632|144618379|SUPERIORITY_OR_OTHER||Ratio of response rate|1.26||||0.4498|TWO_SIDED|95.0|0.69|2.28|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 1 at Week 13. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.||2.28|0.69|0.4498
72544363|NCT01360632|144618379|SUPERIORITY_OR_OTHER||Ratio of response rate|1.6||||0.1009|TWO_SIDED|95.0|0.91|2.82|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 2 at Week 13. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.||2.82|0.91|0.1009
72544364|NCT01360632|144618379|SUPERIORITY_OR_OTHER||Ratio of response rate|1.45||||0.1499|TWO_SIDED|95.0|0.87|2.41|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 1 at Week 14. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.||2.41|0.87|0.1499
72544365|NCT01360632|144618379|SUPERIORITY_OR_OTHER||Ratio of response rate|1.31||||0.3012|TWO_SIDED|95.0|0.78|2.18|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 2 at Week 14. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.||2.18|0.78|0.3012
72544366|NCT01360632|144618380|SUPERIORITY_OR_OTHER||Ratio of response rate|1.41||||0.2873|TWO_SIDED|95.0|0.75|2.65|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 1 at Week 9. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||2.65|0.75|0.2873
72544367|NCT01360632|144618380|SUPERIORITY_OR_OTHER||Ratio of response rate|1.37||||0.2677|TWO_SIDED|95.0|0.79|2.36|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 2 at Week 9. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||2.36|0.79|0.2677
72544368|NCT01360632|144618380|SUPERIORITY_OR_OTHER||Ratio of response rate|1.8||||0.0031|TWO_SIDED|95.0|1.21|2.68|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 1 at Week 10. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||2.68|1.21|0.0031
72579054|NCT01894087|144685845|SUPERIORITY||Incidence Rate Ratio|0.72|||||TWO_SIDED|95.0|0.59|0.87|||||Numerator is Therapist-led Brief Intervention, Denominator is Enhanced Usual Care only.|Multivariable Poisson regression of outcome of overdose risk behavior sum score at 6 months, adjusting for baseline level of the outcome||0.87|0.59|
72579055|NCT01894087|144685846|SUPERIORITY||Slope|0.1|||||TWO_SIDED|95.0|-0.2|0.4|||||Numerator is the Therapist-Led Brief Intervention and Denominator is Enhanced Usual Care only|Multivariable linear regression of the outcome of standardized sum score of overdose symptom knowledge at 6 months follow-up, adjusted for baseline level of overdose symptom knowledge.||0.40|-0.20|
72579056|NCT01894087|144685847|SUPERIORITY||Incidence Rate Ratio|1.11|||||TWO_SIDED|95.0|0.93|1.33|||||This item was reverse coded; higher scores indicate lower intention to avoid overdose risk (for the strategy of using opioids as prescribed). Numerator was the Therapist-Led Brief Intervention and the denominator was Enhanced Usual Care only.|Multivariable Poisson regression of the outcome of intention to use opioids as prescribed, adjusting for baseline level of the outcome.||1.33|0.93|
72579057|NCT01894087|144685847|SUPERIORITY||Incidence Rate Ratio|0.76|||||TWO_SIDED|95.0|0.65|0.9|||||This item was reverse coded; higher scores indicate lower intention to avoid overdose risk (for the strategy of reducing or avoiding opioid use). Numerator was the Therapist-Led Brief Intervention and the denominator was Enhanced Usual Care only.|Multivariable Poisson regression of the outcome of intention to avoid or reduce opioid use, adjusting for baseline level of the outcome.||0.90|0.65|
72579058|NCT01894087|144685847|SUPERIORITY||Incidence Rate Ratio|0.97|||||TWO_SIDED|95.0|0.8|1.19|||||This item was reverse coded; higher scores indicate lower intention to avoid overdose risk (for the strategy of not combining opioids with other drugs). Numerator was Therapist-Led Brief Intervention and denominator was Enhanced Usual Care only.|Multivariable Poisson regression of the outcome of intention to avoid combining opioids with other substances, adjusting for baseline level of the outcome.||1.19|0.80|
72579059|NCT01894087|144685848|SUPERIORITY||Incidence Rate Ratio|0.81|||||TWO_SIDED|95.0|0.7|0.92|||||Numerator is Therapist-Led Brief Intervention, Denominator is Enhanced Usual Care only|Multivariable Poisson regression for the outcome of total COMM score at follow-up, adjusting for baseline level of the outcome||0.92|0.70|
72579060|NCT05534061|144685935|SUPERIORITY||Odds Ratio (OR)|0.98||||0.944|TWO_SIDED|95.0|0.62|1.56||A priori threshold for statistical significance was p\<.05.|Regression, Logistic|A multilevel logistic regression model was specified.|Contingency Management Alone coded as the reference group.|||1.56|0.62|.944
72579061|NCT05534061|144685936|SUPERIORITY||Odds Ratio (OR)|1.01||||0.952|TWO_SIDED|95.0|0.62|1.65||A priori threshold for statistical significance was p\<.05.|Regression, Logistic|A multilevel logistic regression model was specified.|Contingency Management Alone coded as the reference group.|||1.65|0.62|.952
72579062|NCT05534061|144685937|SUPERIORITY||Odds Ratio (OR)|1.16||||0.768|TWO_SIDED|95.0|0.43|3.11||A priori threshold for statistical significance was p\<.05.|Regression, Logistic|A multilevel logistic regression model was specified.|Contingency Management Alone coded as the reference group.|||3.11|0.43|.768
72579063|NCT05534061|144685938|SUPERIORITY||Odds Ratio (OR)|3.96||||0.008|TWO_SIDED|95.0|1.43|10.94||A priori threshold for statistical significance was p\<.05.|Regression, Logistic|A multilevel logistic regression model was specified.|Contingency Management Alone coded as the reference group.|||10.94|1.43|.008
72579064|NCT04138823|144685960|OTHER||Probability of DLT rate in [0.16,0.33)|0.172|||||||||||Bayesian logistic regression model|||Probability of DLT rate was determined using a Bayesian 2-parameter logistic regression model with overdose control.||||
72579065|NCT04138823|144685960|OTHER||Probability of DLT rate in [0.33, 1.00]|0.01||||||||||||||Probability of DLT rate was determined using a Bayesian 2-parameter logistic regression model with overdose control.||||
72579066|NCT04138823|144685960|OTHER||Probabilty of DLT rate in [0.16, 0.33)|0.362||||||||||||||Probability of DLT rate was determined using a Bayesian 2-parameter logistic regression model with overdose control.||||
72579067|NCT04138823|144685960|OTHER||Probability of DLT rate in [0.33, 1.00]|0.046||||||||||||||Probability of DLT rate was determined using a Bayesian 2-parameter logistic regression model with overdose control.||||
72579068|NCT04138823|144685960|OTHER||Probability of DLT rate in [0.16, 0.33)|0.478||||||||||||||"Probability of DLT rate was determined using a Bayesian 2-parameter logistic regression model with overdose control.~The 200 mg BI 891065 BID dose was modelled as equivalent to a 300 mg QD dose in terms of dose-toxicity relationship."||||
72579069|NCT04138823|144685960|OTHER||Probability of DLT rate in [0.33, 1.00]|0.118||||||||||||||"Probability of DLT rate was determined using a Bayesian 2-parameter logistic regression model with overdose control.~The 200 mg BI 891065 BID dose was modelled as equivalent to a 300 mg QD dose in terms of dose-toxicity relationship."||||
72579070|NCT02466685|144685967|SUPERIORITY||Mean Difference (Final Values)|5.0|STANDARD_DEVIATION|9.4|<|0.05|TWO_SIDED||||||ANCOVA|||||||<0.05
72579071|NCT02391987|144685977|SUPERIORITY|||||||0.73|||||||Cochran-Mantel-Haenszel|||||||0.73
72579072|NCT02391987|144685978|SUPERIORITY|||||||0.98|||||||Cochran-Mantel-Haenszel|||||||0.98
72579073|NCT02391987|144685979|SUPERIORITY|||||||0.37|||||||Fisher Exact|||||||0.37
72579074|NCT02213289|144686075|SUPERIORITY|||||||0.0024|||||||One-sided Z-test|This was a test of whether the observed 1-year survival rate was significantly different from historical 50% rate.||||||0.0024
72579075|NCT01579747|144686134|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||t-test, 2 sided|||Normality of distribution was assessed with the Shapiro-Wilk test. For normally-distributed continuous variables, the groups' distributions were described as means and standard deviations (SD). Student's t-test was used to compare groups in these cases with statistically-significant differences summarized using 95% confidence intervals as appropriate. For all comparisons, two-tailed p\<0.05 was considered statistically significant.||||<0.05
72411394|NCT04079933|144331131|EQUIVALENCE|Null hypothesis = Test and Control groups will have equivalent levels of change from baseline to end of study for Fagerstrom Test score for Cigarette Dependence; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of change from baseline to end of study for Fagerstrom Test score for Cigarette Dependence|Mean Difference (Net)|-0.408||||0.0919|TWO_SIDED|95.0|-0.884|0.0673|||t-test, 2 sided||"Difference in LS mean change between study groups using Mixed Effects Repeated Measures Model 1:~Change from baseline=study group + visit + study group\*visit + subject + random error, fitted with unstructured covariance matrix"|Null hypothesis = Test and Control groups will have equivalent levels of change from baseline to end of study for Fagerstrom Test score for Cigarette Dependence; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of change from baseline to end of study for Fagerstrom Test score for Cigarette Dependence||0.0673|-0.884|0.0919
72411395|NCT04079933|144331131|EQUIVALENCE|Null hypothesis = Test and Control groups will have equivalent levels of change from baseline to end of study for Fagerstrom Test score for Cigarette Dependence; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of change from baseline to end of study for Fagerstrom Test score for Cigarette Dependence|Mean Difference (Net)|-0.405||||0.0975|TWO_SIDED|95.0|-0.886|0.0751|||t-test, 2 sided||"Difference in LS means (Test - Control) using Mixed Effects Repeated Measures Model 2:~Change from baseline= study group + visit + study group\*visit + CPD + Sex + Race + BMI + Age + subject + random error, fitted with unstructured covariance matrix"|Null hypothesis = Test and Control groups will have equivalent levels of change from baseline to end of study for Fagerstrom Test score for Cigarette Dependence; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of change from baseline to end of study for Fagerstrom Test score for Cigarette Dependence||0.0751|-0.886|0.0975
72411396|NCT04079933|144331131|EQUIVALENCE|"Statistical Analysis of Difference in Percent Change from Baseline in Total Score of Fagerstrom Test for Cigarette Dependence between the Study Groups.~Null hypothesis = Test and Control groups will have equivalent levels of percent change from baseline to end of study for Fagerstrom Test score for Cigarette Dependence; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of percent change from baseline to end of study for Fagerstrom Test score for Cigarette Dependence"|Mean Difference (Net)|-8.31||||0.0643|TWO_SIDED|95.0|-17.1|0.499|||t-test, 2 sided||"Difference in LS mean percent change between study groups using Mixed Effects Repeated Measures Model 1:~Change from baseline=study group + visit + study group\*visit + subject + random error, fitted with unstructured covariance matrix"|"Statistical Analysis of Difference in Percent Change from Baseline in Total Score of Fagerstrom Test for Cigarette Dependence between the Study Groups.~Null hypothesis = Test and Control groups will have equivalent levels of percent change from baseline to end of study for Fagerstrom Test score for Cigarette Dependence; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of percent change from baseline to end of study for Fagerstrom Test score for Cigarette Dependence"||0.499|-17.1|0.0643
72411397|NCT04079933|144331131|EQUIVALENCE|"Statistical Analysis of Difference in Percent Change from Baseline in Total Score of Fagerstrom Test for Cigarette Dependence between the Study Groups.~Null hypothesis = Test and Control groups will have equivalent levels of percent change from baseline to end of study for Fagerstrom Test score for Cigarette Dependence; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of percent change from baseline to end of study for Fagerstrom Test score for Cigarette Dependence"|Mean Difference (Net)|-8.84||||0.0517|TWO_SIDED|95.0|-17.7|0.0661|||t-test, 2 sided||"Difference in LS means (Test - Control) using Mixed Effects Repeated Measures Model 2:~Change from baseline= study group + visit + study group\*visit + CPD + Sex + Race + BMI + Age + subject + random error, fitted with unstructured covariance matrix"|"Statistical Analysis of Difference in Percent Change from Baseline in Total Score of Fagerstrom Test for Cigarette Dependence between the Study Groups.~Null hypothesis = Test and Control groups will have equivalent levels of percent change from baseline to end of study for Fagerstrom Test score for Cigarette Dependence; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of percent change from baseline to end of study for Fagerstrom Test score for Cigarette Dependence"||0.0661|-17.7|0.0517
72411398|NCT04079933|144331132|EQUIVALENCE|Null hypothesis = Test and Control groups will have equivalent levels of change in quit attempts from baseline to end of study; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of change in quit attempts from baseline to end of study|Probability|0.216||||0.216|TWO_SIDED||||||Fisher Exact||Estimated value is the probability of observed distribution assuming the null hypothesis|Null hypothesis = Test and Control groups will have equivalent levels of change in quit attempts from baseline to end of study; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of change in quit attempts from baseline to end of study||||0.2160
72544369|NCT01360632|144618380|SUPERIORITY_OR_OTHER||Ratio of response rate|1.7||||0.0066|TWO_SIDED|95.0|1.15|2.5|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 2 at Week 10. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||2.50|1.15|0.0066
72579076|NCT04182334|144686135|SUPERIORITY|||||||0.775|||||||Mixed Models Analysis|||||||0.775
72579077|NCT04182334|144686136|SUPERIORITY|||||||0.995|||||||Mixed Models Analysis|||||||0.995
72579078|NCT04182334|144686137|SUPERIORITY|||||||0.674|||||||Mixed Models Analysis|||||||0.674
72579079|NCT04182334|144686138|SUPERIORITY|||||||0.326|||||||Mixed Models Analysis|||||||0.326
72579080|NCT04182334|144686139|SUPERIORITY|||||||0.463|||||||Wilcoxon (Mann-Whitney)|||||||0.463
72579081|NCT04182334|144686140|SUPERIORITY|||||||0.449|||||||Wilcoxon (Mann-Whitney)|||||||0.449
72579082|NCT04182334|144686141|SUPERIORITY|||||||0.505|||||||Wilcoxon (Mann-Whitney)|||||||0.505
72579083|NCT04182334|144686142|SUPERIORITY|||||||0.612|||||||Wilcoxon (Mann-Whitney)|||||||0.612
72579084|NCT04182334|144686143|SUPERIORITY|||||||0.058|||||||Wilcoxon (Mann-Whitney)|||||||0.058
72579085|NCT04182334|144686144|SUPERIORITY|||||||0.196|||||||Wilcoxon (Mann-Whitney)|||||||0.196
72579086|NCT02454608|144686196|SUPERIORITY_OR_OTHER|||||||0.01|||||||Mixed Models Analysis|||||||0.01
72579087|NCT02454608|144686197|SUPERIORITY_OR_OTHER|||||||0.001|||||||Mixed Models Analysis|||||||0.001
72579088|NCT02454608|144686198|SUPERIORITY_OR_OTHER|||||||0.25|||||||Mixed Models Analysis|||||||0.25
72579089|NCT02454608|144686199|SUPERIORITY_OR_OTHER|||||||0.02|||||||t-test, 2 sided|||||||0.02
72579090|NCT02454608|144686200|SUPERIORITY_OR_OTHER|||||||0.6|||||||t-test, 2 sided|||||||0.6
72544370|NCT01360632|144618380|SUPERIORITY_OR_OTHER||Ratio of response rate|1.34||||0.0665|TWO_SIDED|95.0|0.98|1.83|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 1 at Week 11. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||1.83|0.98|0.0665
72544371|NCT01360632|144618380|SUPERIORITY_OR_OTHER||Ratio of response rate|1.41||||0.025|TWO_SIDED|95.0|1.05|1.91|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 2 at Week 11. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||1.91|1.05|0.0250
72544372|NCT01360632|144618380|SUPERIORITY_OR_OTHER||Ratio of response rate|1.18||||0.2224|TWO_SIDED|95.0|0.9|1.54|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 1 at Week 12. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||1.54|0.90|0.2224
72544373|NCT01360632|144618380|SUPERIORITY_OR_OTHER||Ratio of response rate|1.31||||0.0369|TWO_SIDED|95.0|1.01|1.68|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 2 at Week 12. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||1.68|1.01|0.0369
72544374|NCT01360632|144618380|SUPERIORITY_OR_OTHER||Ratio of response rate|1.36||||0.0179|TWO_SIDED|95.0|1.05|1.75|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 1 at Week 13. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||1.75|1.05|0.0179
72544375|NCT01360632|144618380|SUPERIORITY_OR_OTHER||Ratio of response rate|1.49||||0.0011|TWO_SIDED|95.0|1.17|1.89|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 2 at Week 13. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||1.89|1.17|0.0011
72544376|NCT01360632|144618380|SUPERIORITY_OR_OTHER||Ratio of response rate|1.12||||0.3249|TWO_SIDED|95.0|0.89|1.41|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 1 at Week 14. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||1.41|0.89|0.3249
72579091|NCT02454608|144686201|SUPERIORITY_OR_OTHER|||||||0.78|||||||t-test, 2 sided|||||||0.78
72579092|NCT02454608|144686202|SUPERIORITY_OR_OTHER|||||||0.7|||||||t-test, 2 sided|||||||0.7
72544377|NCT01360632|144618380|SUPERIORITY_OR_OTHER||Ratio of response rate|1.33||||0.0122|TWO_SIDED|95.0|1.06|1.66|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 2 at Week 14. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||1.66|1.06|0.0122
72544378|NCT01360632|144618381|SUPERIORITY_OR_OTHER||Ratio of response rate|1.22||||0.5836|TWO_SIDED|95.0|0.6|2.49|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 1 at Week 9. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.||2.49|0.60|0.5836
72579093|NCT00486525|144686258|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.075|STANDARD_ERROR_OF_MEAN|0.058||0.2|TWO_SIDED|95.0|-0.19|0.039|||Mixed Models Analysis|The Kenward-Roger adjustment to the degrees of freedom was used to control Type I error rates.|Yoga minus Control immediately post-treatment|Mixed effect models were used to test the intervention's effect on primary outcomes. Fixed effects included visit, intervention group, their interaction, and baseline outcome levels. Random effects included a subject-specific random intercept, accounting for within-subject correlation, and a random effect for yoga-group, accounting for the partially-nested data arising from small groups being present in the intervention arm but not in the control arm.||0.039|-0.19|0.20
72411399|NCT04079933|144331132|EQUIVALENCE|Null hypothesis = Test and Control groups will have equivalent levels of change in quit attempts from baseline to end of study; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of change in quit attempts from baseline to end of study|Probability|0.0648||||0.0648|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Null hypothesis = Test and Control groups will have equivalent levels of change in quit attempts from baseline to end of study; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of change in quit attempts from baseline to end of study||||0.0648
72544379|NCT01360632|144618381|SUPERIORITY_OR_OTHER||Ratio of response rate|1.31||||0.3792|TWO_SIDED|95.0|0.73|2.37|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 2 at Week 9. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.||2.37|0.73|0.3792
72544380|NCT01360632|144618381|SUPERIORITY_OR_OTHER||Ratio of response rate|1.77||||0.0101|TWO_SIDED|95.0|1.14|2.74|||Ratio of response rate|CMH general association test controlling for trial site||Statistical analysis 1 at Week 10. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.||2.74|1.14|0.0101
72544381|NCT01360632|144618381|SUPERIORITY_OR_OTHER||Ratio of response rate|1.75||||0.0065|TWO_SIDED|95.0|1.17|2.63|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 2 at Week 10. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.||2.63|1.17|0.0065
72544382|NCT01360632|144618381|SUPERIORITY_OR_OTHER||Ratio of response rate|1.41||||0.0526|TWO_SIDED|95.0|1.0|1.99|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 1 at Week 11. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.||1.99|1.00|0.0526
72544383|NCT01360632|144618381|SUPERIORITY_OR_OTHER||Ratio of response rate|1.51||||0.0156|TWO_SIDED|95.0|1.08|2.11|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 2 at Week 11. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.||2.11|1.08|0.0156
72544384|NCT01360632|144618381|SUPERIORITY_OR_OTHER||Ratio of response rate|1.22||||0.1689|TWO_SIDED|95.0|0.92|1.63|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 1 at Week 12. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.||1.63|0.92|0.1689
72544385|NCT01360632|144618381|SUPERIORITY_OR_OTHER||Ratio of response rate|1.37||||0.0231|TWO_SIDED|95.0|1.04|1.8|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 2 at Week 12. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.||1.80|1.04|0.0231
72544386|NCT01360632|144618381|SUPERIORITY_OR_OTHER||Ratio of response rate|1.4||||0.0175|TWO_SIDED|95.0|1.06|1.84|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 1 at Week 13. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.||1.84|1.06|0.0175
72544387|NCT01360632|144618381|SUPERIORITY_OR_OTHER||Ratio of response rate|1.59||||0.0004|TWO_SIDED|95.0|1.22|2.07|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 2 at Week 13. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.||2.07|1.22|0.0004
72544388|NCT01360632|144618381|SUPERIORITY_OR_OTHER||Ratio of response rate|1.21||||0.1396|TWO_SIDED|95.0|0.94|1.55|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 1 at Week 14. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.||1.55|0.94|0.1396
72544389|NCT01360632|144618381|SUPERIORITY_OR_OTHER||Ratio of response rate|1.46||||0.0016|TWO_SIDED|95.0|1.15|1.86|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 2 at Week 14. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.||1.86|1.15|0.0016
72544390|NCT02173301|144618383|SUPERIORITY|||||||0.066|||||||Mixed Models Analysis|Restricted Maximum Likelihood (REML) - an REML-based mixed model for repeated measures (MMRM) with and with baseline PASI score as covariate||||||0.066
72544391|NCT02173301|144618383|SUPERIORITY|||||||0.001|||||||Mixed Models Analysis|Restricted Maximum Likelihood (REML) - an REML-based mixed model for repeated measures (MMRM) with and with baseline PASI score as covariate||||||0.001
72544392|NCT02173301|144618383|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|Restricted Maximum Likelihood (REML) - an REML-based mixed model for repeated measures (MMRM) with and with baseline PASI score as covariate||||||<0.001
72544393|NCT02173301|144618384|SUPERIORITY|||||||0.501|||||||Regression, Logistic|||Week 12 comparison||||0.501
72544394|NCT02173301|144618384|SUPERIORITY|||||||0.34|||||||Regression, Logistic|||Week 12 comparison||||0.340
72544395|NCT02173301|144618384|SUPERIORITY|||||||0.075|||||||Regression, Logistic|||Week 12 comparison||||0.075
72544396|NCT02173301|144618385|SUPERIORITY|||||||0.229|||||||Regression, Logistic|||Week 12 comparison||||0.229
72544397|NCT02173301|144618385|SUPERIORITY|||||||0.604|||||||Regression, Logistic|||Week 12 comparison||||0.604
72544398|NCT02173301|144618385|SUPERIORITY|||||||0.573|||||||Regression, Logistic|||Week 12 comparison||||0.573
72579094|NCT00486525|144686258|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.13|STANDARD_ERROR_OF_MEAN|0.06||0.027|TWO_SIDED|95.0|-0.25|-0.015|||Mixed Models Analysis|The Kenward-Roger adjustment to the degrees of freedom was used to control Type I error rates.|Yoga minus Control 3 months post-treatment|Mixed effect models were used to test the intervention's effect on primary outcomes. Fixed effects included visit, intervention group, their interaction, and baseline outcome levels. Random effects included a subject-specific random intercept, accounting for within-subject correlation, and a random effect for yoga-group, accounting for the partially-nested data arising from small groups being present in the intervention arm but not in the control arm.||-0.015|-0.25|0.027
72579095|NCT00486525|144686258|SUPERIORITY_OR_OTHER||Slope|-0.021|STANDARD_ERROR_OF_MEAN|0.02||0.28|TWO_SIDED|95.0|-0.06|0.018|||Mixed Models Analysis|The Kenward-Roger adjustment to the degrees of freedom was used to control Type I error rates.|Model used continuous yoga practice frequency in place of group assignment to predict primary outcomes immediately post-treatment.|Secondary analysis on change of ln (TNF-a) for each 10 minute increase in yoga practice frequency, adjusting for baseline outcome levels, age, and SAD.||0.018|-0.060|0.28
72579096|NCT00486525|144686258|SUPERIORITY_OR_OTHER||Slope|-0.038|STANDARD_ERROR_OF_MEAN|0.02||0.063|TWO_SIDED|95.0|-0.079|0.0021|||Mixed Models Analysis|The Kenward-Roger adjustment to the degrees of freedom was used to control Type I error rates.|Model used continuous yoga practice frequency in place of group assignment to predict primary outcomes 3 months post-treatment.|Secondary analysis on change of ln (TNF-a) for each 10 minute increase in yoga practice frequency, adjusting for baseline outcome levels, age, and SAD.||0.0021|-0.079|0.063
72579097|NCT00486525|144686259|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.079|STANDARD_ERROR_OF_MEAN|0.062||0.2|TWO_SIDED|95.0|-0.2|-0.042|||Mixed Models Analysis|The Kenward-Roger adjustment to the degrees of freedom was used to control Type I error rates.|Yoga minus Control immediately post-treatment|Mixed effect models were used to test the intervention's effect on primary outcomes. Fixed effects included visit, intervention group, their interaction, and baseline outcome levels. Random effects included a subject-specific random intercept, accounting for within-subject correlation, and a random effect for yoga-group, accounting for the partially-nested data arising from small groups being present in the intervention arm but not in the control arm.||-0.042|-0.2|0.2
72579098|NCT00486525|144686259|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.16|STANDARD_ERROR_OF_MEAN|0.064||0.015|TWO_SIDED|95.0|-0.28|-0.031|||Mixed Models Analysis|The Kenward-Roger adjustment to the degrees of freedom was used to control Type I error rates.|Yoga minus Control 3 months post-treatment|Mixed effect models were used to test the intervention's effect on primary outcomes. Fixed effects included visit, intervention group, their interaction, and baseline outcome levels. Random effects included a subject-specific random intercept, accounting for within-subject correlation, and a random effect for yoga-group, accounting for the partially-nested data arising from small groups being present in the intervention arm but not in the control arm.||-0.031|-0.28|0.015
72579099|NCT00486525|144686259|SUPERIORITY_OR_OTHER||Slope|-0.022|STANDARD_ERROR_OF_MEAN|0.021||0.3|TWO_SIDED|95.0|-0.063|0.019|||Mixed Models Analysis|The Kenward-Roger adjustment to the degrees of freedom was used to control Type I error rates.|Model used continuous yoga practice frequency in place of group assignment to predict primary outcomes immediately post-treatment.|Secondary analysis on change of ln (IL-6) for each 10 minute increase in yoga practice frequency, adjusting for baseline outcome levels, age, and SAD.||0.019|-0.063|0.3
72579100|NCT00486525|144686259|SUPERIORITY_OR_OTHER||Slope|-0.056|STANDARD_ERROR_OF_MEAN|0.022||0.01|TWO_SIDED|95.0|-0.098|-0.013|||Mixed Models Analysis|The Kenward-Roger adjustment to the degrees of freedom was used to control Type I error rates.|Model used continuous yoga practice frequency in place of group assignment to predict primary outcomes 3 months post-treatment.|Secondary analysis on change of ln (IL-6) for each 10 minute increase in yoga practice frequency, adjusting for baseline outcome levels, age, and SAD.||-0.013|-0.098|0.01
72579101|NCT00486525|144686260|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.11||0.33|TWO_SIDED|95.0|-0.31|0.11|||Mixed Models Analysis|The Kenward-Roger adjustment to the degrees of freedom was used to control Type I error rates.|Yoga minus Control immediately post-treatment|Mixed effect models were used to test the intervention's effect on primary outcomes. Fixed effects included visit, intervention group, their interaction, and baseline outcome levels. Random effects included a subject-specific random intercept, accounting for within-subject correlation, and a random effect for yoga-group, accounting for the partially-nested data arising from small groups being present in the intervention arm but not in the control arm.||0.11|-0.31|0.33
72579102|NCT00486525|144686260|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.23|STANDARD_ERROR_OF_MEAN|0.11||0.037|TWO_SIDED|95.0|-0.44|-0.014|||Mixed Models Analysis|The Kenward-Roger adjustment to the degrees of freedom was used to control Type I error rates.|Yoga minus Control 3 months post-treatment|Mixed effect models were used to test the intervention's effect on primary outcomes. Fixed effects included visit, intervention group, their interaction, and baseline outcome levels. Random effects included a subject-specific random intercept, accounting for within-subject correlation, and a random effect for yoga-group, accounting for the partially-nested data arising from small groups being present in the intervention arm but not in the control arm.||-0.014|-0.44|0.037
72579103|NCT00486525|144686260|SUPERIORITY_OR_OTHER||Slope|-0.034|STANDARD_ERROR_OF_MEAN|0.0235||0.33|TWO_SIDED|95.0|-0.1|0.035|||Mixed Models Analysis|The Kenward-Roger adjustment to the degrees of freedom was used to control Type I error rates.|Model used continuous yoga practice frequency in place of group assignment to predict primary outcomes immediately post-treatment.|Secondary analysis on change of ln (IL-1b) for each 10 minute increase in yoga practice frequency, adjusting for baseline outcome levels, age, and SAD.||0.035|-0.10|0.33
72579104|NCT00486525|144686260|SUPERIORITY_OR_OTHER||Slope|-0.078|STANDARD_ERROR_OF_MEAN|0.036||0.03|TWO_SIDED|95.0|-0.15|-0.0074|||Mixed Models Analysis|The Kenward-Roger adjustment to the degrees of freedom was used to control Type I error rates.|Model used continuous yoga practice frequency in place of group assignment to predict primary outcomes 3 months post-treatment.|Secondary analysis on change of ln (IL-1b) for each 10 minute increase in yoga practice frequency, adjusting for baseline outcome levels, age, and SAD.||-0.0074|-0.15|0.03
72329491|NCT03037476|144184395|OTHER|General Linear Model|Slope|-0.0136||||0.808|TWO_SIDED|95.0|-0.1236|0.0963|||Mixed Models Analysis|Negative Binomial Regression||Change in past month typical alcohol quantity at 12 month follow-up||0.0963|-0.1236|0.808
72411400|NCT04079933|144331133|EQUIVALENCE|Null hypothesis = Test and Control groups will have equivalent levels of change in quitting intentions from baseline to end of study; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of change in quitting intentions from baseline to end of study|Probability|0.5977||||0.5977|TWO_SIDED||||||Fisher Exact||Estimated value is the probability of observed distribution assuming the null hypothesis|Null hypothesis = Test and Control groups will have equivalent levels of change in quitting intentions from baseline to end of study; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of change in quitting intentions from baseline to end of study||||0.5977
72579105|NCT00486525|144686261|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.2|STANDARD_ERROR_OF_MEAN|2.2||0.058|TWO_SIDED|95.0|-8.5|0.15|||Mixed Models Analysis|The Kenward-Roger adjustment to the degrees of freedom was used to control Type I error rates.|Yoga minus Control immediately post-treatment|Mixed effect models were used to test the intervention's effect on primary outcomes. Fixed effects included visit, intervention group, their interaction, and baseline outcome levels. Random effects included a subject-specific random intercept, accounting for within-subject correlation, and a random effect for yoga-group, accounting for the partially-nested data arising from small groups being present in the intervention arm but not in the control arm.||0.15|-8.5|0.058
72579106|NCT00486525|144686261|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.0|STANDARD_ERROR_OF_MEAN|2.2||0.002|TWO_SIDED|95.0|-11.4|-2.7|||Mixed Models Analysis|The Kenward-Roger adjustment to the degrees of freedom was used to control Type I error rates.|Yoga minus Control 3 months post-treatment|Mixed effect models were used to test the intervention's effect on primary outcomes. Fixed effects included visit, intervention group, their interaction, and baseline outcome levels. Random effects included a subject-specific random intercept, accounting for within-subject correlation, and a random effect for yoga-group, accounting for the partially-nested data arising from small groups being present in the intervention arm but not in the control arm.||-2.7|-11.4|0.002
72579107|NCT00486525|144686261|SUPERIORITY_OR_OTHER||Slope|-1.7|STANDARD_ERROR_OF_MEAN|0.7||0.019|TWO_SIDED|95.0|-3.1|-0.28|||Mixed Models Analysis|The Kenward-Roger adjustment to the degrees of freedom was used to control Type I error rates.|Model used continuous yoga practice frequency in place of group assignment to predict primary outcomes immediately post-treatment.|Secondary analysis on change of MFSI-SF Fatigue for each 10 minute increase in yoga practice frequency, adjusting for baseline outcome levels, age, and SAD.||-0.28|-3.1|0.019
72579108|NCT00486525|144686261|SUPERIORITY_OR_OTHER||Slope|-2.8|STANDARD_ERROR_OF_MEAN|0.71||0.0001|TWO_SIDED|95.0|-4.2|-1.4|||Mixed Models Analysis|The Kenward-Roger adjustment to the degrees of freedom was used to control Type I error rates.|Model used continuous yoga practice frequency in place of group assignment to predict primary outcomes 3 months post-treatment.|Secondary analysis on change of MFSI-SF fatigue for each 10 minute increase in yoga practice frequency, adjusting for baseline outcome levels, age, and SAD.||-1.4|-4.2|0.0001
72579109|NCT00486525|144686262|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.4|STANDARD_ERROR_OF_MEAN|2.5||0.01|TWO_SIDED|95.0|1.4|11.4|||Mixed Models Analysis|The Kenward-Roger adjustment to the degrees of freedom was used to control Type I error rates.|Yoga minus Control immediately post-treatment|Mixed effect models were used to test the intervention's effect on primary outcomes. Fixed effects included visit, intervention group, their interaction, and baseline outcome levels. Random effects included a subject-specific random intercept, accounting for within-subject correlation, and a random effect for yoga-group, accounting for the partially-nested data arising from small groups being present in the intervention arm but not in the control arm.||11.4|1.4|0.01
72579110|NCT00486525|144686262|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.6|STANDARD_ERROR_OF_MEAN|2.5||0.01|TWO_SIDED|95.0|1.5|11.6|||Mixed Models Analysis|The Kenward-Roger adjustment to the degrees of freedom was used to control Type I error rates.|Yoga minus Control 3 months post-treatment|Mixed effect models were used to test the intervention's effect on primary outcomes. Fixed effects included visit, intervention group, their interaction, and baseline outcome levels. Random effects included a subject-specific random intercept, accounting for within-subject correlation, and a random effect for yoga-group, accounting for the partially-nested data arising from small groups being present in the intervention arm but not in the control arm.||11.6|1.5|0.01
72579111|NCT00486525|144686262|SUPERIORITY_OR_OTHER||Slope|2.1|STANDARD_ERROR_OF_MEAN|0.85||0.016|TWO_SIDED|95.0|0.4|3.75|||Mixed Models Analysis|The Kenward-Roger adjustment to the degrees of freedom was used to control Type I error rates.|Model used continuous yoga practice frequency in place of group assignment to predict primary outcomes immediately post-treatment.|Secondary analysis on change of vitality (SF-36) for each 10 minute increase in yoga practice frequency, adjusting for baseline outcome levels, age, and SAD.||3.75|0.40|0.016
72579112|NCT00486525|144686262|SUPERIORITY_OR_OTHER||Slope|2.5|STANDARD_ERROR_OF_MEAN|0.85||0.0045|TWO_SIDED|95.0|0.77|4.14|||Mixed Models Analysis|The Kenward-Roger adjustment to the degrees of freedom was used to control Type I error rates.|Model used continuous yoga practice frequency in place of group assignment to predict primary outcomes 3 months post-treatment.|Secondary analysis on change of vitality (SF-36) for each 10 minute increase in yoga practice frequency, adjusting for baseline outcome levels, age, and SAD.||4.14|0.77|0.0045
72579113|NCT00486525|144686263|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.1|STANDARD_ERROR_OF_MEAN|0.98||0.28|TWO_SIDED|95.0|-3.0|0.88|||Mixed Models Analysis|The Kenward-Roger adjustment to the degrees of freedom was used to control Type I error rates.|Yoga minus Control immediately post-treatment|Mixed effect models were used to test the intervention's effect on primary outcomes. Fixed effects included visit, intervention group, their interaction, and baseline outcome levels. Random effects included a subject-specific random intercept, accounting for within-subject correlation, and a random effect for yoga-group, accounting for the partially-nested data arising from small groups being present in the intervention arm but not in the control arm.||0.88|-3.0|0.28
72579114|NCT00486525|144686263|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.3|STANDARD_ERROR_OF_MEAN|0.99||0.21|TWO_SIDED|95.0|-3.2|0.69|||Mixed Models Analysis|The Kenward-Roger adjustment to the degrees of freedom was used to control Type I error rates.|Yoga minus Control 3 months post-treatment|Mixed effect models were used to test the intervention's effect on primary outcomes. Fixed effects included visit, intervention group, their interaction, and baseline outcome levels. Random effects included a subject-specific random intercept, accounting for within-subject correlation, and a random effect for yoga-group, accounting for the partially-nested data arising from small groups being present in the intervention arm but not in the control arm.||0.69|-3.2|0.21
72579115|NCT00486525|144686263|SUPERIORITY_OR_OTHER||Slope|-0.66|STANDARD_ERROR_OF_MEAN|0.34||0.051|TWO_SIDED|95.0|-1.3|0.0039|||Mixed Models Analysis|The Kenward-Roger adjustment to the degrees of freedom was used to control Type I error rates.|Model used continuous yoga practice frequency in place of group assignment to predict primary outcomes immediately post-treatment.|Secondary analysis on change of CES-D for each 10 minute increase in yoga practice frequency, adjusting for baseline outcome levels, age, and SAD.||0.0039|-1.3|0.051
72579116|NCT00486525|144686263|SUPERIORITY_OR_OTHER||Slope|-0.56|STANDARD_ERROR_OF_MEAN|0.34||0.098|TWO_SIDED|95.0|-1.2|0.1|||Mixed Models Analysis|The Kenward-Roger adjustment to the degrees of freedom was used to control Type I error rates.|Model used continuous yoga practice frequency in place of group assignment to predict primary outcomes 3 months post-treatment.|Secondary analysis on change of CESD for each 10 minute increase in yoga practice frequency, adjusting for baseline outcome levels, age, and SAD.||0.10|-1.2|0.098
72579117|NCT03573830|144686264|SUPERIORITY||Mean Difference (Final Values)|0.12||||0.002|TWO_SIDED|95.0|0.04|0.2||Threshold for significance: \<0.05|t-test, 2 sided|||||0.20|0.04|0.002
72579118|NCT03573830|144686265|SUPERIORITY||Mean Difference (Final Values)|0.15||||0|TWO_SIDED|95.0|0.07|0.22||Threshold for significance: 0.05|t-test, 2 sided|||||0.22|0.07|0.000
72579119|NCT03573830|144686266|SUPERIORITY||Mean Difference (Final Values)|0.02||||0.352|TWO_SIDED|95.0|-0.03|0.07||Threshold for significance: 0.05|t-test, 2 sided|||||0.07|-0.03|0.352
72579120|NCT03573830|144686267|SUPERIORITY||Mean Difference (Final Values)|0.45||||0|TWO_SIDED|95.0|0.34|0.56||Threshold for significance: \<0.05|t-test, 2 sided|||||0.56|0.34|0.000
72579121|NCT03573830|144686268|SUPERIORITY||Mean Difference (Final Values)|0.13||||0.002|TWO_SIDED|95.0|0.05|0.22||Threshold for significance: 0.05|t-test, 2 sided|||||0.22|0.05|0.002
72579122|NCT03573830|144686269|SUPERIORITY||Mean Difference (Final Values)|32.56||||0.033|TWO_SIDED|95.0|2.65|62.46||Threshold for significance: \<0.05|t-test, 2 sided|||||62.46|2.65|0.033
72579123|NCT03573830|144686271|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.065|TWO_SIDED|95.0|0.0|0.19||Threshold for significance: \<0.05|t-test, 2 sided|||||0.19|0.00|0.065
72579124|NCT03573830|144686272|SUPERIORITY||Mean Difference (Final Values)|0.14||||0.03|TWO_SIDED|95.0|0.01|0.28||Threshold for significance: \<0.05|t-test, 2 sided|||||0.28|0.01|0.030
72579125|NCT01769456|144686274|OTHER||||||<|0.0001||||||Reported p-value is the calculated value provided by SAS output.|Wilcoxon Signed Rank Test|||||||< 0.0001
72579126|NCT01769456|144686275|OTHER|||||||0.0236|||||||Wilcoxon Signed Rank Test|||||||0.0236
72579127|NCT01769456|144686276|OTHER|||||||0.0003|||||||Wilcoxon Signed Rank Test|||||||0.0003
72579128|NCT01769456|144686277|OTHER|||||||0.0236|||||||Wilcoxon Signed Rank Test|||||||0.0236
72579129|NCT02969382|144686311|SUPERIORITY||Mean Difference (Net)|-7.5|STANDARD_ERROR_OF_MEAN|2.23||0.001|TWO_SIDED|95.0|-11.9|-3.0|||Mixed Models Analysis|||||-3.0|-11.9|0.001
72579130|NCT02969382|144686312|SUPERIORITY||Mean Difference (Net)|-0.5|STANDARD_ERROR_OF_MEAN|0.12|<|0.001|TWO_SIDED|95.0|-0.7|-0.2|||Mixed Models Analysis|||||-0.2|-0.7|<0.001
72579131|NCT02969382|144686313|SUPERIORITY||Mean Difference (Net)|-1.7|STANDARD_ERROR_OF_MEAN|0.71||0.019|TWO_SIDED|95.0|-3.1|-0.3|||Mixed Models Analysis|||||-0.3|-3.1|0.019
72544399|NCT00325403|144618401|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehmann (H-L)|23.0||||0.0125|TWO_SIDED|95.0|4.0|41.0||P-Value|ANCOVA|||Using an allocation ratio of 2:1 between oral treprostinil and placebo, a fixed sample size of approximately 195 subjects with access to 0.25 mg tablets at randomization would provide at least 90% power at a significance level of 0.01 (two-sided hypothesis) to detect a between-treatment difference in the change from Baseline to Week 12 in distance traversed during the 6-minute walk, assuming a true underlying treatment difference of 45 meters with a SD of 75 meters in both treatment groups.||41|4|0.0125
72544400|NCT00325403|144618402|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehmann (H-L)|13.0||||0.0653|TWO_SIDED|95.0|-2.0|33.0|||ANCOVA|||||33|-2|0.0653
72544401|NCT00325403|144618403|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehmann (H-L)|17.0||||0.0307|TWO_SIDED|95.0|1.0|33.0|||ANCOVA|||||33|1|0.0307
72544402|NCT00325403|144618404|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehmann (H-L)|12.0||||0.0518|TWO_SIDED|95.0|0.0|24.0|||ANCOVA|||||24|0|0.0518
72544403|NCT00325403|144618405|SUPERIORITY_OR_OTHER_LEGACY|||||||1||95.0|||||Fisher Exact|||||||1.000
72544404|NCT00325403|144618406|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehmann (H-L)|0.0||||0.738|TWO_SIDED|95.0|0.0|0.0||"In cases where the value corresponding to overall poorest relative change was imputed for walk distance, a value of IV was used for the WHO functional classification for PAH."|Wilcoxon rank sum test||The values for the estimated parameter and 95% confidence interval were calculated.|||0|0|0.7380
72544405|NCT00325403|144618407|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehmann (H-L)|0.0||||0.4887|TWO_SIDED|95.0|-1.0|0.0|||Wilcoxon rank-sum test|||||0|-1|0.4887
72544406|NCT00325403|144618408|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehmann (H-L)|0.0||||0.6116|TWO_SIDED|95.0|0.0|1.0|||Wilcoxon sum-rank test|||||1|0|0.6116
72579132|NCT02969382|144686314|SUPERIORITY||Mean Difference (Net)|-1.5|STANDARD_ERROR_OF_MEAN|0.55||0.008|TWO_SIDED|95.0|-2.6|-0.4|||Mixed Models Analysis|||||-0.4|-2.6|0.008
72544407|NCT00325403|144618410|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehmann (H-L)|26.0||||0.0326|TWO_SIDED|95.0|1.0|49.0|||ANCOVA|||||49|1|0.0326
72544408|NCT00325403|144618411|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehmann (H-L)|16.0||||0.2275|TWO_SIDED|95.0|-15.0|47.0|||ANCOVA|||||47|-15|0.2275
72544409|NCT00325403|144618412|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehmann (H-L)|32.0||||0.0024|TWO_SIDED|95.0|10.0|55.0|||ANCOVA|||||55|10|0.0024
72544410|NCT00325403|144618413|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehmann (H-L)|25.5||||0.0001|TWO_SIDED|95.0|10.0|41.0|||ANCOVA|||||41|10|0.0001
72544411|NCT00325403|144618414|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehmann (H-L)|17.0||||0.0025|TWO_SIDED|95.0|3.0|33.0|||ANCOVA|||||33|3|0.0025
72579133|NCT02969382|144686315|SUPERIORITY||Mean Difference (Net)|-4.3|STANDARD_ERROR_OF_MEAN|1.15|<|0.001|TWO_SIDED|95.0|-6.6|-2.0|||Mixed Models Analysis|||||-2.0|-6.6|<0.001
72579134|NCT02969382|144686316|SUPERIORITY||Mean Difference (Net)|-4.3|STANDARD_ERROR_OF_MEAN|1.26|<|0.001|TWO_SIDED|95.0|-6.8|-1.8|||Mixed Models Analysis|||||-1.8|-6.8|<0.001
72544412|NCT00325403|144618415|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehmann (H-L)|20.0||||0.0008|TWO_SIDED|95.0|7.0|34.0|||ANCOVA|||||34|7|0.0008
72544413|NCT00325403|144618416|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehmann (H-L)|14.0||||0.0025|TWO_SIDED|95.0|3.9|25.0|||ANCOVA|||||25|3.9|0.0025
72544414|NCT00672620|144618437|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.58|STANDARD_ERROR_OF_MEAN|1.036||0.577|TWO_SIDED|95.0|-2.61|1.46||Pre-specified sequential statistical testing procedure indicates that when p-value \>0.05, hierarchical testing stops and for subsequent endpoints in the sequence a nominal p-value is provided.|ANCOVA|ANCOVA with treatment and center as fixed factors, baseline HAM-D24 as covariate.||All statistical tests were 2-sided with 95% confidence intervals (CIs), and with P-values evaluated at the 5% significance level (ie, statistical significance if P\<0.05). To control for multiplicity, a pre-specified sequential testing procedure was applied to compare 5 mg and 2.5 mg vortioxetine to placebo; as soon as an endpoint was non-significant at 0.05, the testing procedure stopped for all subsequent endpoints.||1.46|-2.61|0.577
72544415|NCT00672620|144618437|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.54|STANDARD_ERROR_OF_MEAN|1.038||0.138|TWO_SIDED|95.0|-3.58|0.5|||ANCOVA|ANCOVA with treatment and center as fixed factors, baseline HAM-D24 as covariate.||||0.50|-3.58|0.138
72544416|NCT00672620|144618437|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.96|STANDARD_ERROR_OF_MEAN|1.047||0.005|TWO_SIDED|95.0|-5.02|-0.91|||ANCOVA|ANCOVA with treatment and center as fixed factors, baseline HAM-D24 as covariate.||||-0.91|-5.02|0.005
72544417|NCT03211156|144618454|OTHER|||||||0.757|||||||Chi-squared, Corrected|||||||0.757
72544418|NCT03211156|144618455|OTHER|||||||0.048|||||||Fisher Exact|||||||0.048
72544419|NCT00829413|144618456|SUPERIORITY_OR_OTHER||Difference in Sensitivity (%)|37.8|||<|0.0001|TWO_SIDED|95.0|27.4|48.2|||McNemar|||||48.2|27.4|<.0001
72544420|NCT00829413|144618456|SUPERIORITY_OR_OTHER||Difference in Sensitivity (%)|40.3|||<|0.0001|TWO_SIDED|95.0|30.4|50.3|||McNemar|||||50.3|30.4|<.0001
72544421|NCT00829413|144618456|SUPERIORITY_OR_OTHER||Difference in Sensitivity (%)|75.6|||<|0.0001|TWO_SIDED|95.0|67.9|83.3|||McNemar|||||83.3|67.9|<.0001
72544422|NCT00829413|144618457|SUPERIORITY_OR_OTHER||Difference in Specificity (%)|7.9||||0.138|TWO_SIDED|95.0|-2.4|18.2|||McNemar|||||18.2|-2.4|0.1380
72544423|NCT00829413|144618457|SUPERIORITY_OR_OTHER||Difference in Specificity (%)|28.6|||<|0.0001|TWO_SIDED|95.0|19.7|37.5|||McNemar|||||37.5|19.7|<.0001
72544424|NCT00829413|144618457|SUPERIORITY_OR_OTHER||Difference in Specificity (%)|50.7|||<|0.0001|TWO_SIDED|95.0|42.0|59.5|||McNemar|||||59.5|42.0|<.0001
72544425|NCT00829413|144618458|SUPERIORITY_OR_OTHER||Difference in Accuracy (%)|21.6|||<|0.0001|TWO_SIDED|95.0|14.1|29.2|||McNemar|||||29.2|14.1|<.0001
72544426|NCT00829413|144618458|SUPERIORITY_OR_OTHER||Difference in Accuracy (%)|34.0|||<|0.0001|TWO_SIDED|95.0|27.3|40.7|||McNemar|||||40.7|27.3|<.0001
72579135|NCT02969382|144686317|SUPERIORITY||Mean Difference (Net)|-1.8|STANDARD_ERROR_OF_MEAN|0.75||0.02|TWO_SIDED|95.0|-3.2|-0.3|||Mixed Models Analysis|||||-0.3|-3.2|0.020
72579136|NCT02969382|144686318|SUPERIORITY||Odds Ratio (OR)|2.645||||0.002|TWO_SIDED|95.0|1.422|4.921|||Regression, Logistic|||||4.921|1.422|0.002
72579137|NCT02969382|144686320|OTHER|||||||0.498|||||||Fisher Exact|||||||0.498
72579138|NCT02969382|144686321|OTHER||||||>|0.999|||||||Fisher Exact|||||||>0.999
72579139|NCT02969382|144686322|OTHER|||||||0.498|||||||Fisher Exact|||||||0.498
72544427|NCT00829413|144618458|SUPERIORITY_OR_OTHER||Difference in Accuracy (%)|75.6|||<|0.0001|TWO_SIDED|95.0|67.9|83.3|||McNemar|||||83.3|67.9|<.0001
72544428|NCT00829413|144618459|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wald Test|||||||<.0001
72544429|NCT00829413|144618459|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wald Test|||||||<.0001
72544430|NCT00829413|144618459|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wald Test|||||||<.0001
72544431|NCT00829413|144618460|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wald Test|||||||<.0001
72544432|NCT00829413|144618460|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wald Test|||||||<.0001
72544433|NCT00829413|144618460|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wald Test|||||||<.0001
72544434|NCT00124020|144618477|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin of 20% was specified based on historical regulatory precedent.|Risk Difference (RD)|0.2||||||95.0|-6.8|7.2||p-values were not calculated in deference to confidence intervals.||||||7.2|-6.8|
72544435|NCT01127581|144618485|SUPERIORITY_OR_OTHER||Median Difference (Net)|-677.0|||<|0.001|TWO_SIDED|95.0|||||Log Rank||Sample size 675 per group provides 90% power to see an improvement of ≥320 minutes (20% improvement from DVI) in time to vaginal delivery between MVI 200 \& DVI assuming a median time of 1600 minutes for DVI \& 34% dropout rate based on 5% 2-sided test|Subjects who underwent a cesarean delivery during the first hospitalization were censored using the longest time interval from study drug administration to cesarean delivery during the first hospitalization, independent of treatment group. Subjects who, in their first hospitalization, were discharged prior to delivery or withdrew consent prior to delivery were censored using the longest time interval from study drug administration to labor and delivery discharge, independent of treatment group.||||<0.001
72544436|NCT01127581|144618486|NON_INFERIORITY_OR_EQUIVALENCE|A sample size of 675 subjects per group will provide a sufficient number of subjects to assess non-inferiority of MVI 200 with respect to rate of cesarean delivery, based on an alpha level of 5% and 80% power for a two-sided approach using a 10% non-inferiority limit (relative to the DVI rate), assuming a 30% rate of cesarean delivery in the DVI group compared to a 26% rate in the MVI 200 group.|Difference in Populations|-1.1|||||TWO_SIDED|95.0|-5.79|3.59|||Chi-squared||MVI 200 - DVI|The analysis of the cesarean delivery rates during the first hospitalization was based on a between-treatment-group difference. If the upper limit of the asymptotic two-sided 95% confidence interval of the difference in event rates (MVI minus DVI) was less than the calculated non-inferiority margin (10% relative to the DVI rate, i.e., 0.1 times DVI rate), then MVI 200 would be considered non-inferior to DVI.||3.59|-5.79|
72544437|NCT01127581|144618487|SUPERIORITY_OR_OTHER||Median Difference (Net)|-543.0|||<|0.001|TWO_SIDED|95.0|||||Log Rank||MVI 200 - DVI|Subjects who did not deliver during the first hospitalization were censored using the longest time interval from study drug administration to labor and delivery discharge without delivery, independent of treatment group.||||<0.001
72544438|NCT01127581|144618488|SUPERIORITY_OR_OTHER||Median Difference (Net)|-390.0|||<|0.001|TWO_SIDED|95.0|||||Log Rank||MVI 200 - DVI|Subjects who never went into active labor during the first hospitalization were censored using the longest time interval from study drug administration to delivery during the first hospitalization, independent of treatment group. Subjects who, in their first hospitalization, were discharged prior to delivery or withdrew consent prior to delivery were censored using the longest time interval from study drug administration to labor and delivery discharge, independent of treatment group.||||<0.001
72544439|NCT01127581|144618489|SUPERIORITY_OR_OTHER||Difference in Proportions|-26.0|||<|0.001|TWO_SIDED|95.0|||||Fisher Exact||MVI 200 - DVI|||||<0.001
72544440|NCT01127581|144618490|SUPERIORITY_OR_OTHER||Difference in Proportions|9.67|||<|0.001|TWO_SIDED|95.0|||||Fisher Exact||MVI 200 - DVI|||||<0.001
72544441|NCT01127581|144618491|SUPERIORITY_OR_OTHER||Difference in Proportions|26.96|||<|0.001|TWO_SIDED|95.0|||||Fisher Exact||MVI 200 - DVI|||||<0.001
72544442|NCT01127581|144618492|SUPERIORITY_OR_OTHER||Difference in Proportions|13.9|||<|0.001|TWO_SIDED|95.0|||||Fisher Exact||MVI 200 - DVI|||||<0.001
72544443|NCT01127581|144618493|SUPERIORITY_OR_OTHER||Difference in Proportions|29.8|||<|0.001|TWO_SIDED|95.0|||||Fisher Exact||MVI 200 - DVI|||||<0.001
72544444|NCT01127581|144618494|SUPERIORITY_OR_OTHER||Difference in Proportions|1.68|||<|0.001|TWO_SIDED|95.0|||||Fisher Exact||MVI 200 - DVI|||||<0.001
72544445|NCT02927847|144618509|OTHER||t-value|0.138||||0.891|TWO_SIDED||||||t-test, 2 sided|||||||0.891
72544446|NCT02927847|144618510|OTHER||t-value|-0.575||||0.571|TWO_SIDED||||||t-test, 2 sided|||||||0.571
72544447|NCT02927847|144618511|OTHER||Odds Ratio (OR)|1.17||||0.739|TWO_SIDED||||||Regression, Cox|||||||0.739
72544448|NCT00723554|144618533|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-6.1|||<|0.001|TWO_SIDED|95.0|-6.9|-5.4|||t-test, 2 sided|||Comparison of the change in average inhalation times from Period I (PD-6) to Period II (PD-15)||-5.4|-6.9|<0.001
72544449|NCT00723554|144618537|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.2||||0.59|TWO_SIDED|95.0|-1.0|0.6|||t-test, 2 sided|||Comparison of the change in average number of days of dosing from Period I (PD-6) to Period II (PD-15)||0.6|-1.0|0.59
72544450|NCT00723554|144618541|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.5|||<|0.001|TWO_SIDED|95.0|0.2|0.7|||t-test, 2 sided|||Comparison of the change in average number of daily doses from Period I (PD-6) to Period II (PD-15)||0.7|0.2|<0.001
72544451|NCT00723554|144618545|SUPERIORITY_OR_OTHER||Mean Difference (Net)|11.0|||<|0.0001|TWO_SIDED|95.0|6.5|15.6|||t-test, 2 sided|||Comparison of the change in percentage of complete doses delivered from Period I (PD-6) to Period II (PD-15)||15.6|6.5|<0.0001
72411401|NCT04079933|144331134|EQUIVALENCE|Null hypothesis = The Day 1(Weekly Recall) and Day 8 (Daily Tracking using IVRS) methods will have equivalent levels of change in mean exposure of NNAL; Alternate hypothesis = The Day 1(Weekly Recall) and Day 8 (Daily Tracking using IVRS) methods will NOT have equivalent levels of change from baseline to end of study in mean exposure of NNAL|Mean Difference (Net)|10.0||||0.4388|TWO_SIDED|95.0|-15.5|35.5|||t-test, 2 sided|||Null hypothesis = The Day 1(Weekly Recall) and Day 8 (Daily Tracking using IVRS) methods will have equivalent levels of change in mean exposure of NNAL; Alternate hypothesis = The Day 1(Weekly Recall) and Day 8 (Daily Tracking using IVRS) methods will NOT have equivalent levels of change from baseline to end of study in mean exposure of NNAL||35.5|-15.5|0.4388
72544452|NCT01614509|144618573|NON_INFERIORITY_OR_EQUIVALENCE|Central retinal thickness was measured using an optical coherence tomography by every visit intended for all participants.||||||0.6||95.0|||||Wilcoxon (Mann-Whitney)|||Central retinal thickness was measured using an optical coherence tomography by every visit. And we compare the difference of central retinal thickness between two groups||||0.60
72544453|NCT00125931|144618578|SUPERIORITY_OR_OTHER|||||||0.01|ONE_SIDED|95.0|||||ANOVA|||comparison of mean scores at hour 2 vs 3||||0.01
72544454|NCT00125931|144618579|SUPERIORITY_OR_OTHER|||||||0.01||95.0|||||t-test, 1 sided|||comparison of mean score on treatment vs post-treatment days||||0.01
72544455|NCT00125931|144618579|SUPERIORITY_OR_OTHER|||||||0.4||95.0|||||t-test, 1 sided|||comparison of mean scores at pre-treatment vs treatment days||||0.4
72544456|NCT01086215|144618603|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Mixed Models Analysis|Alternative hypothesis is change in occlusion \>0||||||<0.0001
72544457|NCT01086215|144618603|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Mixed Models Analysis|Alternative hypothesis is change in occlusion \>0||||||<0.0001
72544458|NCT01086215|144618603|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Mixed Models Analysis|Alternative hypothesis is change in occlusion \>0||||||<0.0001
72544459|NCT01086215|144618603|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Mixed Models Analysis|Alternative hypothesis is change in occlusion \>0||||||<0.0001
72579140|NCT05490771|144686324|SUPERIORITY|||||||0.0341|||||||one-sided exact binomial test|||The ORR was compared against a null benchmark value of 5%. If the observed ORR were ≥5 of 31 (16%), it would then be concluded that the agent is promising and worthy of further investigation. When the number of analyzable cases (who were eligible and treated, and with outside assay results confirmed by the central MATCH assay) was \<31, the one-sided exact binomial test would be used for significance test with one-side type I error rate of 5%.||||0.0341
72544460|NCT00408876|144618640|SUPERIORITY_OR_OTHER|||||||0.503||95.0|||||Repeated Measures|||||||0.503
72544461|NCT00408876|144618640|SUPERIORITY_OR_OTHER|||||||0.447||95.0|||||Repeated Measures|||||||0.447
72544462|NCT00408876|144618640|SUPERIORITY_OR_OTHER|||||||0.084||95.0|||||Repeated Measures|||||||0.084
72544463|NCT00408876|144618640|SUPERIORITY_OR_OTHER|||||||0.964||95.0|||||Repeated Measures|||||||0.964
72544464|NCT00408876|144618640|SUPERIORITY_OR_OTHER|||||||0.451||95.0|||||Repeated Measures|||||||0.451
72544465|NCT00408876|144618640|SUPERIORITY_OR_OTHER|||||||0.333||95.0|||||Repeated Measures|||||||0.333
72544466|NCT00408876|144618641|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.21||||0.318||95.0|-0.62|0.2|||t-test, 2 sided|||||0.20|-0.62|0.318
72544467|NCT00408876|144618641|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.49||||0.005||95.0|-0.83|-0.15|||t-test, 2 sided|||||-0.15|-0.83|0.005
72544468|NCT00408876|144618641|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.27||||0.124||95.0|-0.61|0.07|||t-test, 2 sided|||||0.07|-0.61|0.124
72544469|NCT00408876|144618641|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.28||||0.183||95.0|-0.7|0.13|||t-test, 2 sided|||||0.13|-0.70|0.183
72544470|NCT00408876|144618641|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.06||||0.778||95.0|-0.48|0.36|||t-test, 2 sided|||||0.36|-0.48|0.778
72544471|NCT00408876|144618641|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.22||||0.21||95.0|-0.13|0.57|||t-test, 2 sided|||||0.57|-0.13|0.210
72544472|NCT00408876|144618642|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.97||||0.161||95.0|-2.32|0.39|||t-test, 2 sided|||||0.39|-2.32|0.161
72544473|NCT00408876|144618642|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.41||||0.019||95.0|-2.59|-0.24|||t-test, 2 sided|||||-0.24|-2.59|0.019
72544474|NCT00408876|144618642|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.56||||0.01||95.0|-2.74|-0.38|||t-test, 2 sided|||||-0.38|-2.74|0.010
72544475|NCT00408876|144618642|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.45||||0.526||95.0|-1.83|0.94|||t-test, 2 sided|||||0.94|-1.83|0.526
72544476|NCT00408876|144618642|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.59||||0.397||95.0|-1.96|0.78|||t-test, 2 sided|||||0.78|-1.96|0.397
72544477|NCT00408876|144618642|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.15||||0.813||95.0|-1.35|1.06|||t-test, 2 sided|||||1.06|-1.35|0.813
72544478|NCT00408876|144618643|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.15||||0.657||95.0|-0.5|0.79|||t-test, 2 sided|||||0.79|-0.50|0.657
72544479|NCT00408876|144618643|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.23||||0.384||95.0|-0.76|0.29|||t-test, 2 sided|||||0.29|-0.76|0.384
72544480|NCT00408876|144618643|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.56||||0.04||95.0|-1.1|-0.03|||t-test, 2 sided|||||-0.03|-1.10|0.040
72544481|NCT00408876|144618643|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.38||||0.253||95.0|-1.03|0.27|||t-test, 2 sided|||||0.27|-1.03|0.253
72544482|NCT00408876|144618643|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.71||||0.034||95.0|-1.36|-0.05|||t-test, 2 sided|||||-0.05|-1.36|0.034
72544483|NCT00408876|144618643|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.33||||0.232||95.0|-0.86|0.21|||t-test, 2 sided|||||0.21|-0.86|0.232
72544484|NCT00408876|144618644|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.33||||0.365||95.0|-0.39|1.05|||t-test, 2 sided|||||1.05|-0.39|0.365
72544485|NCT00408876|144618644|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.36||||0.232||95.0|-0.95|0.23|||t-test, 2 sided|||||0.23|-0.95|0.232
72544486|NCT00408876|144618644|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.3||||0.314||95.0|-0.9|0.29|||t-test, 2 sided|||||0.29|-0.90|0.314
72579141|NCT02422797|144686354|NON_INFERIORITY|Non-inferiority was concluded if the lower bound of a two-sided 95% confidence interval for the difference in response rates between the two treatment arms was greater than -10%.|Risk Difference (RD)|0.2|||||TWO_SIDED|95.0|-3.9|4.2|||||Estimates based on Cochran-Mantel Haenszel stratified analysis adjusting for Baseline stratification factors: Age group (\< or \>=50 years old) and Baseline third agent (PI, NNRTI, INSTI).|||4.2|-3.9|
72579142|NCT02422797|144686356|OTHER||Risk Difference (RD)|-1.1|||||TWO_SIDED|95.0|-4.0|1.8|||||Cochran-Mantel Haenszel stratified analysis adjusting for Baseline stratification factors: Age group (\< or \>=50 years old) and Baseline third agent (PI, NNRTI, INSTI). No formal non-inferiority margin has been pre-specified for secondary endpoints.|||1.8|-4.0|
72579143|NCT02422797|144686367|OTHER|||||||0.007||||||P-value for interaction between treatment group and Baseline third agent (25 hydroxy-vitamin D)|ANCOVA|||||||0.007
72579144|NCT02422797|144686367|SUPERIORITY||Odds Ratio (OR)|0.861||||0.011|TWO_SIDED|95.0|0.767|0.967||P value assessed the difference between treatment groups (25 hydroxy-vitamin D - INSTI)|ANCOVA||Estimates were calculated from an ANCOVA model adjusting for Baseline third agent class, age, sex, BMI category, smoking status and Baseline biomarker level.|||0.967|0.767|0.011
72579145|NCT02422797|144686367|SUPERIORITY||Odds Ratio (OR)|1.012||||0.745|TWO_SIDED|95.0|0.943|1.085||P value assessed the difference between treatment groups (25 hydroxy-vitamin D - NNRTI)|ANCOVA||Estimates were calculated from an ANCOVA model adjusting for Baseline third agent class, age, sex, BMI category, smoking status and Baseline biomarker level.|||1.085|0.943|0.745
72579146|NCT02422797|144686367|SUPERIORITY||Odds Ratio (OR)|0.877||||0.018|TWO_SIDED|95.0|0.787|0.977||P value assessed the difference between treatment groups (25 hydroxy-vitamin D - PI)|ANCOVA||Estimates were calculated from an ANCOVA model adjusting for Baseline third agent class, age, sex, BMI category, smoking status and Baseline biomarker level.|||0.977|0.787|0.018
72579147|NCT02422797|144686369|OTHER|||||||0.001||||||P-value for interaction between treatment group and Baseline third agent (bone-specific alkaline phosphatase)|ANCOVA|||||||0.001
72579148|NCT02422797|144686369|SUPERIORITY||Odds Ratio (OR)|0.728|||<|0.001|TWO_SIDED|95.0|0.686|0.773||P value assessed the difference between treatment groups (bone-specific alkaline phosphatase - NNRTI)|ANCOVA||Estimates were calculated from an ANCOVA model adjusting for Baseline third agent class, age, sex, BMI category, smoking status and Baseline biomarker level.|||0.773|0.686|<.001
72579149|NCT02422797|144686369|SUPERIORITY||Odds Ratio (OR)|0.865||||0.004|TWO_SIDED|95.0|0.785|0.954||P value assessed the difference between treatment groups (bone-specific alkaline phosphatase - INSTI)|ANCOVA||Estimates were calculated from an ANCOVA model adjusting for Baseline third agent class, age, sex, BMI category, smoking status and Baseline biomarker level.|||0.954|0.785|0.004
72579150|NCT02422797|144686369|SUPERIORITY||Odds Ratio (OR)|0.788|||<|0.001|TWO_SIDED|95.0|0.719|0.864||P value assessed the difference between treatment groups (bone-specific alkaline phosphatase - PI)|ANCOVA||Estimates were calculated from an ANCOVA model adjusting for Baseline third agent class, age, sex, BMI category, smoking status and Baseline biomarker level.|||0.864|0.719|<.001
72579151|NCT02422797|144686369|OTHER|||||||0.677||||||P-value for interaction between treatment group and Baseline third agent (procollagen type 1-N-propeptide)|ANCOVA|||||||0.677
72579152|NCT02422797|144686369|SUPERIORITY||Odds Ratio (OR)|0.867|||<|0.001|TWO_SIDED|95.0|0.823|0.914||P value assessed the difference between treatment groups (procollagen type 1-N-propeptide)|ANCOVA||Estimates were calculated from an ANCOVA model adjusting for Baseline third agent class, age, sex, BMI category, smoking status and Baseline biomarker level.|||0.914|0.823|<.001
72579153|NCT02422797|144686369|OTHER||||||<|0.001||||||P-value for interaction between treatment group and Baseline third agent (osteocalcin)|ANCOVA|||||||<.001
72579154|NCT02422797|144686369|SUPERIORITY||Odds Ratio (OR)|0.853|||<|0.001|TWO_SIDED|95.0|0.799|0.91||P value assessed the difference between treatment groups (osteocalcin - NNRTI)|ANCOVA||Estimates were calculated from an ANCOVA model adjusting for Baseline third agent class, age, sex, BMI category, smoking status and Baseline biomarker level.|||0.910|0.799|<.001
72579155|NCT02422797|144686369|SUPERIORITY||Odds Ratio (OR)|0.886||||0.028|TWO_SIDED|95.0|0.796|0.987||P value assessed the difference between treatment groups (osteocalcin - INSTI)|ANCOVA||Estimates were calculated from an ANCOVA model adjusting for Baseline third agent class, age, sex, BMI category, smoking status and Baseline biomarker level.|||0.987|0.796|0.028
72579156|NCT02422797|144686369|SUPERIORITY||Odds Ratio (OR)|0.743|||<|0.001|TWO_SIDED|95.0|0.672|0.822||P value assessed the difference between treatment groups (osteocalcin - PI)|ANCOVA||Estimates were calculated from an ANCOVA model adjusting for Baseline third agent class, age, sex, BMI category, smoking status and Baseline biomarker level.|||0.822|0.672|<.001
72579157|NCT02422797|144686369|OTHER|||||||0.782||||||P-value for interaction between treatment group and Baseline third agent (type 1 collagen cross-linked C-telopeptide)|ANCOVA|||||||0.782
72579158|NCT02422797|144686369|SUPERIORITY||Odds Ratio (OR)|0.818|||<|0.001|TWO_SIDED|95.0|0.751|0.891||P value assessed the difference between treatment groups (type 1 collagen cross-linked C-telopeptide)|ANCOVA||Estimates were calculated from an ANCOVA model adjusting for Baseline third agent class, age, sex, BMI category, smoking status and Baseline biomarker level.|||0.891|0.751|<.001
72579159|NCT02422797|144686382|OTHER|||||||0.179||||||One-sided p-value from weighted least squares chi-squared statistic. A p-value \<=0.10 was used to indicate statistically significant evidence of heterogeneity in the difference in proportions across levels of each analysis strata.|Chi-squared, Corrected|||||||0.179
72579160|NCT02422797|144686382|OTHER||Risk Difference (RD)|3.5|||||TWO_SIDED|95.0|-1.6|8.6|||||NNRTI: No formal non-inferiority margin has been pre-specified for secondary endpoints.|||8.6|-1.6|
72579161|NCT02422797|144686382|OTHER||Risk Difference (RD)|-2.4|||||TWO_SIDED|95.0|-12.1|7.4|||||INSTI: No formal non-inferiority margin has been pre-specified for secondary endpoints.|||7.4|-12.1|
72579162|NCT02422797|144686382|OTHER||Risk Difference (RD)|-5.4|||||TWO_SIDED|95.0|-13.9|3.1|||||PI: No formal non-inferiority margin has been pre-specified for secondary endpoints.|||3.1|-13.9|
72579163|NCT02422797|144686390|OTHER|||||||0.43||||||P-value for interaction between treatment group and Baseline symptom bother score (Week 4)|ANCOVA|||||||0.430
72579164|NCT02422797|144686390|OTHER||Mean Difference (Final Values)|-1.239||||0.039|TWO_SIDED|95.0|-2.414|-0.064||P value assessed the difference between treatment groups (Symptom Bother Score - Week 4)|ANCOVA||Estimates were calculated from an ANCOVA model adjusting for age, Baseline third agent, gender, race and Baseline score.|||-0.064|-2.414|0.039
72579165|NCT02422797|144686390|OTHER|||||||0.542||||||P-value for interaction between treatment group and Baseline symptom bother score (Week 24)|ANCOVA|||||||0.542
72544487|NCT00408876|144618644|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.69||||0.062||95.0|-1.41|0.03|||t-test, 2 sided|||||0.03|-1.41|0.062
72544488|NCT00408876|144618644|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.64||||0.083||95.0|-1.36|0.08|||t-test, 2 sided|||||0.08|-1.36|0.083
72544489|NCT00408876|144618644|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.05||||0.859||95.0|-0.54|0.65|||t-test, 2 sided|||||0.65|-0.54|0.859
72544490|NCT00408876|144618645|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0||||0.984||95.0|-0.34|0.34|||t-test, 2 sided|||||0.34|-0.34|0.984
72544491|NCT00408876|144618645|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.41||||0.004||95.0|-0.7|-0.13|||t-test, 2 sided|||||-0.13|-0.70|0.004
72579166|NCT02422797|144686390|SUPERIORITY||Mean Difference (Final Values)|-0.528||||0.448|TWO_SIDED|95.0|-1.896|0.84||P value assessed the difference between treatment groups (Symptom Bother Score - Week 24)|ANCOVA||Estimates were calculated from an ANCOVA model adjusting for age, Baseline third agent, gender, race and Baseline score.|||0.840|-1.896|0.448
72579167|NCT02422797|144686390|OTHER|||||||0.402||||||P-value for interaction between treatment group and Baseline symptom bother score (Week 48)|ANCOVA|||||||0.402
72579168|NCT02422797|144686390|SUPERIORITY||Mean Difference (Final Values)|-1.037||||0.164|TWO_SIDED|95.0|-2.501|0.426||P value assessed the difference between treatment groups (Symptom Bother Score - Week 48)|ANCOVA||Estimates were calculated from an ANCOVA model adjusting for age, Baseline third agent, gender, race and Baseline score.|||0.426|-2.501|0.164
72579169|NCT02422797|144686393|SUPERIORITY|||||||0.037||||||P-value assessed the HIVTSQs Total Score difference between treatment groups (Week 4)|Wilcoxon rank sum test|||||||0.037
72579170|NCT02422797|144686393|SUPERIORITY|||||||0.101||||||P-value assessed the HIVTSQs Total Score difference between treatment groups (Week 24)|Wilcoxon rank sum test|||||||0.101
72544492|NCT00408876|144618645|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.53|||<|0.001||95.0|-0.81|-0.24|||t-test, 2 sided|||||-0.24|-0.81|<0.001
72544493|NCT00408876|144618645|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.42||||0.018||95.0|-0.76|-0.07|||t-test, 2 sided|||||-0.07|-0.76|0.018
72544494|NCT00408876|144618645|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.53||||0.003||95.0|-0.87|-0.19|||t-test, 2 sided|||||-0.19|-0.87|0.003
72579171|NCT02422797|144686393|SUPERIORITY|||||||0.042||||||P-value assessed the HIVTSQs Total score difference between treatment groups (Week 48)|Wilcoxon rank sum test|||||||0.042
72579172|NCT02422797|144686393|SUPERIORITY|||||||0.132||||||P-value assessed the HIVTSQs lifestyle/ease sub- score difference between treatment groups (Week 4)|Wilcoxon rank sum test|||||||0.132
72544495|NCT00408876|144618645|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.11||||0.442||95.0|-0.4|0.17|||t-test, 2 sided|||||0.17|-0.40|0.442
72544496|NCT00408876|144618646|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.31||||0.464||95.0|-0.52|1.14|||t-test, 2 sided|||||1.14|-0.52|0.464
72544497|NCT00408876|144618646|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.68||||0.052||95.0|-1.36|0.0|||t-test, 2 sided|||||0.00|-1.36|0.052
72544498|NCT00408876|144618646|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.68||||0.052||95.0|-1.37|0.01|||t-test, 2 sided|||||0.01|-1.37|0.052
72544499|NCT00408876|144618646|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.99||||0.021||95.0|-1.83|-0.15|||t-test, 2 sided|||||-0.15|-1.83|0.021
72544500|NCT00408876|144618646|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.99||||0.02||95.0|-1.83|-0.16|||t-test, 2 sided|||||-0.16|-1.83|0.020
72544501|NCT00408876|144618646|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.01||||0.988||95.0|-0.7|0.69|||t-test, 2 sided|||||0.69|-0.70|0.988
72544502|NCT00408876|144618647|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.21||||0.543||95.0|-0.46|0.88|||t-test, 2 sided|||||0.88|-0.46|0.543
72544503|NCT00408876|144618647|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.55||||0.053||95.0|-1.1|0.01|||t-test, 2 sided|||||0.01|-1.10|0.053
72544504|NCT00408876|144618647|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.65||||0.024||95.0|-1.21|-0.09|||t-test, 2 sided|||||-0.09|-1.21|0.024
72544505|NCT00408876|144618647|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.75||||0.03||95.0|-1.43|-0.07|||t-test, 2 sided|||||-0.07|-1.43|0.030
72544506|NCT00408876|144618647|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.85||||0.014||95.0|-1.54|-0.17|||t-test, 2 sided|||||-0.17|-1.54|0.014
72544507|NCT00408876|144618647|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1||||0.727||95.0|-0.66|0.46|||t-test, 2 sided|||||0.46|-0.66|0.727
72579173|NCT02422797|144686393|SUPERIORITY|||||||0.022||||||P-value assessed the HIVTSQs lifestyle/ease sub- score difference between treatment groups (Week 24)|Wilcoxon rank sum test|||||||0.022
72579174|NCT02422797|144686393|SUPERIORITY|||||||0.004||||||P-value assessed the HIVTSQs lifestyle/ease sub- score difference between treatment groups (Week 48)|Wilcoxon rank sum test|||||||0.004
72579175|NCT02422797|144686393|SUPERIORITY|||||||0.076||||||P-value assessed the HIVTSQs General satisfaction/CS sub- score difference between treatment groups (Week 4)|Wilcoxon rank sum test|||||||0.076
72579176|NCT02422797|144686393|SUPERIORITY|||||||0.073||||||P-value assessed the HIVTSQs General satisfaction/CS sub- score difference between treatment groups (Week 24)|Wilcoxon rank sum test|||||||0.073
72579177|NCT02422797|144686393|SUPERIORITY|||||||0.547||||||P-value assessed the HIVTSQs General satisfaction/CS sub- score difference between treatment groups (Week 48)|Wilcoxon rank sum test|||||||0.547
72579178|NCT00403585|144686482|SUPERIORITY_OR_OTHER||||||<|0.001||||||The p value represents the comparison between baseline data and data at Week 156.|Wilcoxon signed rank|||||||<0.001
72579179|NCT02964312|144686490|SUPERIORITY||Proportion|89.5|||||TWO_SIDED|95.0|83.5|93.9||||||The null hypothesis was that the proportion of responders at 6 months would be 50%. Since there was not direct comparison group, the hypothesis was set as a superiority comparison to a target proportion (66%) with a power level \>90%.||93.9|83.5|
72411402|NCT04079933|144331135|EQUIVALENCE|Null hypothesis = The Day 1(Weekly Recall) and Day 8 (Daily Tracking using IVRS) methods will have equivalent levels of change in mean exposure of nicotine metabolites; Alternate hypothesis = The Day 1(Weekly Recall) and Day 8 (Daily Tracking using IVRS) methods will NOT have equivalent levels of change from baseline to end of study in mean exposure of nicotine metabolites|Mean Difference (Net)|0.45||||0.339|TWO_SIDED|95.0|-0.48|1.38|||t-test, 2 sided|||Null hypothesis = The Day 1(Weekly Recall) and Day 8 (Daily Tracking using IVRS) methods will have equivalent levels of change in mean exposure of nicotine metabolites; Alternate hypothesis = The Day 1(Weekly Recall) and Day 8 (Daily Tracking using IVRS) methods will NOT have equivalent levels of change from baseline to end of study in mean exposure of nicotine metabolites||1.38|-0.48|0.3390
72411403|NCT04079933|144331136|EQUIVALENCE|Null hypothesis = The Day 1(Weekly Recall) and Day 8 (Daily Tracking using IVRS) methods will have equivalent levels of change in mean exposure of S-PMA; Alternate hypothesis = The Day 1(Weekly Recall) and Day 8 (Daily Tracking using IVRS) methods will NOT have equivalent levels of change from baseline to end of study in mean exposure of S-PMA|Mean Difference (Net)|-205.0||||0.4526|TWO_SIDED|95.0|-745.0|334.0|||t-test, 2 sided|||Null hypothesis = The Day 1(Weekly Recall) and Day 8 (Daily Tracking using IVRS) methods will have equivalent levels of change in mean exposure of S-PMA; Alternate hypothesis = The Day 1(Weekly Recall) and Day 8 (Daily Tracking using IVRS) methods will NOT have equivalent levels of change from baseline to end of study in mean exposure of S-PMA||334|-745|0.4526
72544508|NCT00408876|144618648|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.09||||0.813||95.0|-0.63|0.8|||t-test, 2 sided|||||0.80|-0.63|0.813
72544509|NCT00408876|144618648|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.63||||0.035||95.0|-1.21|-0.04|||t-test, 2 sided|||||-0.04|-1.21|0.035
72544510|NCT00408876|144618648|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.58||||0.054||95.0|-1.17|0.01|||t-test, 2 sided|||||0.01|-1.17|0.054
72544511|NCT00408876|144618648|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.71||||0.051||95.0|-1.43|0.0|||t-test, 2 sided|||||0.00|-1.43|0.051
72544512|NCT00408876|144618648|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.67||||0.07||95.0|-1.39|0.05|||t-test, 2 sided|||||0.05|-1.39|0.070
72544513|NCT00408876|144618648|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.05||||0.872||95.0|-0.54|0.64|||t-test, 2 sided|||||0.64|-0.54|0.872
72544514|NCT00408876|144618649|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.11||||0.79||95.0|-0.68|0.89|||t-test, 2 sided|||||0.89|-0.68|0.790
72544515|NCT00408876|144618649|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.93||||0.005||95.0|-1.57|-0.28|||t-test, 2 sided|||||-0.28|-1.57|0.005
72544516|NCT00408876|144618649|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.87||||0.009||95.0|-1.52|-0.22|||t-test, 2 sided|||||-0.22|-1.52|0.009
72544517|NCT00408876|144618649|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.03||||0.011||95.0|-1.83|-0.24|||t-test, 2 sided|||||-0.24|-1.83|0.011
72544518|NCT00408876|144618649|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.97||||0.016||95.0|-1.77|-0.18|||t-test, 2 sided|||||-0.18|-1.77|0.016
72579180|NCT02964312|144686493|SUPERIORITY||||||<|0.001||||||P values are based on paired t-tests for change from baseline with p\<0.05 indicating significance.|t-test, 2 sided|||||||<0.001
72579181|NCT03126435|144686541|SUPERIORITY|||||||0.6647|||||||Log Rank|P-Value is from a stratified log-rank test.||||||0.6647
72544519|NCT00408876|144618649|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.06||||0.857||95.0|-0.6|0.72|||t-test, 2 sided|||||0.72|-0.60|0.857
72544520|NCT00408876|144618650|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.03||||0.948||95.0|-0.81|0.76|||t-test, 2 sided|||||0.76|-0.81|0.948
72544521|NCT00408876|144618650|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.55||||0.096||95.0|-1.2|0.1|||t-test, 2 sided|||||0.10|-1.20|0.096
72544522|NCT00408876|144618650|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.39||||0.239||95.0|-1.05|0.26|||t-test, 2 sided|||||0.26|-1.05|0.239
72544523|NCT00408876|144618650|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.53||||0.196||95.0|-1.32|0.27|||t-test, 2 sided|||||0.27|-1.32|0.196
72544524|NCT00408876|144618650|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.37||||0.367||95.0|-1.17|0.43|||t-test, 2 sided|||||0.43|-1.17|0.367
72544525|NCT00408876|144618650|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.16||||0.637||95.0|-0.5|0.82|||t-test, 2 sided|||||0.82|-0.50|0.637
72544526|NCT00408876|144618651|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.05||||0.887||95.0|-0.76|0.65|||t-test, 2 sided|||||0.65|-0.76|0.887
72544527|NCT00408876|144618651|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.81||||0.006||95.0|-1.4|-0.23|||t-test, 2 sided|||||-0.23|-1.40|0.006
72544528|NCT00408876|144618651|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.26||||0.392||95.0|-0.84|0.33|||t-test, 2 sided|||||0.33|-0.84|0.392
72544529|NCT00408876|144618651|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.76||||0.036||95.0|-1.48|-0.05|||t-test, 2 sided|||||-0.05|-1.48|0.036
72544530|NCT00408876|144618651|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.2||||0.573||95.0|-0.92|0.51|||t-test, 2 sided|||||0.51|-0.92|0.573
72544531|NCT00408876|144618651|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.56||||0.064||95.0|-0.03|1.15|||t-test, 2 sided|||||1.15|-0.03|0.064
72544532|NCT00408876|144618652|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.36||||0.374||95.0|-1.15|0.43|||t-test, 2 sided|||||0.43|-1.15|0.374
72544533|NCT00408876|144618652|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.9||||0.007||95.0|-1.55|-0.25|||t-test, 2 sided|||||-0.25|-1.55|0.007
72544534|NCT00408876|144618652|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.46||||0.169||95.0|-1.12|0.2|||t-test, 2 sided|||||0.20|-1.12|0.169
72544535|NCT00408876|144618652|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.54||||0.182||95.0|-1.35|0.26|||t-test, 2 sided|||||0.26|-1.35|0.182
72544536|NCT00408876|144618652|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1||||0.802||95.0|-0.91|0.7|||t-test, 2 sided|||||0.70|-0.91|0.802
72544537|NCT00408876|144618652|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.44||||0.191||95.0|-0.22|1.11|||t-test, 2 sided|||||1.11|-0.22|0.191
72544538|NCT00408876|144618653|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.25||||0.556||95.0|-1.1|0.59|||t-test, 2 sided|||||0.59|-1.10|0.556
72579182|NCT03126435|144686542|SUPERIORITY|||||||0.4345|||||||Log Rank|P-Value is from a stratified log-rank test.||||||0.4345
72579183|NCT03126435|144686543|SUPERIORITY|||||||0.2632|||||||Regression, Logistic|P-value is from logistic regression model adjusted for stratification factors among non-missing records||||||0.2632
72579184|NCT03126435|144686545|SUPERIORITY|||||||0.1002|||||||Regression, Logistic|P-value is from logistic regression model adjusted for stratification factors among non-missing records.||||||0.1002
72544539|NCT00408876|144618653|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.73||||0.041||95.0|-1.42|-0.03|||t-test, 2 sided|||||-0.03|-1.42|0.041
72544540|NCT00408876|144618653|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.44||||0.22||95.0|-1.14|0.26|||t-test, 2 sided|||||0.26|-1.14|0.220
72544541|NCT00408876|144618653|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.47||||0.278||95.0|-1.33|0.38|||t-test, 2 sided|||||0.38|-1.33|0.278
72544542|NCT00408876|144618653|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.18||||0.673||95.0|-1.04|0.68|||t-test, 2 sided|||||0.68|-1.04|0.673
72544543|NCT00408876|144618653|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.29||||0.422||95.0|-0.42|1.0|||t-test, 2 sided|||||1.00|-0.42|0.422
72544544|NCT00408876|144618654|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.39||||0.234||95.0|-1.03|0.25|||t-test, 2 sided|||||0.25|-1.03|0.234
72544545|NCT00408876|144618654|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.93|||<|0.001||95.0|-1.46|-0.4|||t-test, 2 sided|||||-0.40|-1.46|<0.001
72544546|NCT00408876|144618654|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.34||||0.213||95.0|-0.87|0.2|||t-test, 2 sided|||||0.20|-0.87|0.213
72544547|NCT00408876|144618654|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.54||||0.105||95.0|-1.19|0.11|||t-test, 2 sided|||||0.11|-1.19|0.105
72544548|NCT00408876|144618654|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.05||||0.876||95.0|-0.6|0.7|||t-test, 2 sided|||||0.70|-0.60|0.876
72544549|NCT00408876|144618654|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.59||||0.033||95.0|0.05|1.13|||t-test, 2 sided|||||1.13|0.05|0.033
72544550|NCT00408876|144618655|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.04||||0.925||95.0|-0.73|0.8|||t-test, 2 sided|||||0.80|-0.73|0.925
72544551|NCT00408876|144618655|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.85||||0.008||95.0|-1.49|-0.22|||t-test, 2 sided|||||-0.22|-1.49|0.008
72544552|NCT00408876|144618655|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.49||||0.132||95.0|-1.12|0.15|||t-test, 2 sided|||||0.15|-1.12|0.132
72544553|NCT00408876|144618655|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.89||||0.024||95.0|-1.67|-0.12|||t-test, 2 sided|||||-0.12|-1.67|0.024
72544554|NCT00408876|144618655|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.52||||0.184||95.0|-1.3|0.25|||t-test, 2 sided|||||0.25|-1.30|0.184
72544555|NCT00408876|144618655|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.37||||0.262||95.0|-0.27|1.01|||t-test, 2 sided|||||1.01|-0.27|0.262
72544556|NCT00408876|144618656|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.07||||0.849||95.0|-0.84|0.69|||t-test, 2 sided|||||0.69|-0.84|0.849
72544557|NCT00408876|144618656|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.73||||0.024||95.0|-1.36|-0.1|||t-test, 2 sided|||||-0.10|-1.36|0.024
72544558|NCT00408876|144618656|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.09||||0.773||95.0|-0.73|0.54|||t-test, 2 sided|||||0.54|-0.73|0.773
72544559|NCT00408876|144618656|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.66||||0.097||95.0|-1.43|0.12|||t-test, 2 sided|||||0.12|-1.43|0.097
72544560|NCT00408876|144618656|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.02||||0.96||95.0|-0.79|0.75|||t-test, 2 sided|||||0.75|-0.79|0.960
72544561|NCT00408876|144618656|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.64||||0.052||95.0|0.0|1.28|||t-test, 2 sided|||||1.28|0.00|0.052
72544562|NCT00408876|144618657|SUPERIORITY_OR_OTHER|||||||0.756||95.0|||||Repeated Measures|||||||0.756
72544563|NCT00408876|144618657|SUPERIORITY_OR_OTHER|||||||0.507||95.0|||||Repeated Measures|||||||0.507
72544564|NCT00408876|144618657|SUPERIORITY_OR_OTHER|||||||0.056||95.0|||||Repeated Measures|||||||0.056
72544565|NCT00408876|144618657|SUPERIORITY_OR_OTHER|||||||0.816||95.0|||||Repeated Measures|||||||0.816
72544566|NCT00408876|144618657|SUPERIORITY_OR_OTHER|||||||0.208||95.0|||||Repeated Measures|||||||0.208
72544567|NCT00408876|144618657|SUPERIORITY_OR_OTHER|||||||0.212||95.0|||||Repeated Measures|||||||0.212
72544568|NCT00408876|144618658|SUPERIORITY_OR_OTHER|||||||0.885||95.0|||||Repeated Measures|||||||0.885
72544569|NCT00408876|144618658|SUPERIORITY_OR_OTHER|||||||0.026||95.0|||||Repeated Measures|||||||0.026
72544570|NCT00408876|144618658|SUPERIORITY_OR_OTHER|||||||0.007||95.0|||||Repeated Measures|||||||0.007
72544571|NCT00408876|144618658|SUPERIORITY_OR_OTHER|||||||0.095||95.0|||||Repeated Measures|||||||0.095
72544572|NCT00408876|144618658|SUPERIORITY_OR_OTHER|||||||0.04||95.0|||||Repeated Measures|||||||0.040
72544573|NCT00408876|144618658|SUPERIORITY_OR_OTHER|||||||0.635||95.0|||||Repeated Measures|||||||0.635
72544574|NCT00408876|144618659|SUPERIORITY_OR_OTHER|||||||0.575||95.0|||||Repeated Measures|||||||0.575
72544575|NCT00408876|144618659|SUPERIORITY_OR_OTHER|||||||0.009||95.0|||||Repeated Measures|||||||0.009
72544576|NCT00408876|144618659|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Repeated Measures|||||||<0.001
72544577|NCT00408876|144618659|SUPERIORITY_OR_OTHER|||||||0.115||95.0|||||Repeated Measures|||||||0.115
72544578|NCT00408876|144618659|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||Repeated Measures|||||||0.002
72544579|NCT00408876|144618659|SUPERIORITY_OR_OTHER|||||||0.072||95.0|||||Repeated Measures|||||||0.072
72544580|NCT00408876|144618660|SUPERIORITY_OR_OTHER|||||||0.516||95.0|||||Repeated Measures|||||||0.516
72544581|NCT00408876|144618660|SUPERIORITY_OR_OTHER|||||||0.006||95.0|||||Repeated Measures|||||||0.006
72544582|NCT00408876|144618660|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Repeated Measures|||||||<0.001
72544583|NCT00408876|144618660|SUPERIORITY_OR_OTHER|||||||0.112||95.0|||||Repeated Measures|||||||0.112
72544584|NCT00408876|144618660|SUPERIORITY_OR_OTHER|||||||0.01||95.0|||||Repeated Measures|||||||0.010
72544585|NCT00408876|144618660|SUPERIORITY_OR_OTHER|||||||0.219||95.0|||||Repeated Measures|||||||0.219
72544586|NCT00408876|144618661|SUPERIORITY_OR_OTHER|||||||0.309||95.0|||||Repeated Measures|||||||0.309
72544587|NCT00408876|144618661|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||Repeated Measures|||||||0.001
72544588|NCT00408876|144618661|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Repeated Measures|||||||<0.001
72544589|NCT00408876|144618661|SUPERIORITY_OR_OTHER|||||||0.116||95.0|||||Repeated Measures|||||||0.116
72544590|NCT00408876|144618661|SUPERIORITY_OR_OTHER|||||||0.033||95.0|||||Repeated Measures|||||||0.033
72544591|NCT00408876|144618661|SUPERIORITY_OR_OTHER|||||||0.48||95.0|||||Repeated Measures|||||||0.480
72544592|NCT00408876|144618662|SUPERIORITY_OR_OTHER|||||||0.709||95.0|||||Repeated Measures|||||||0.709
72544593|NCT00408876|144618662|SUPERIORITY_OR_OTHER|||||||0.012||95.0|||||Repeated Measures|||||||0.012
72544594|NCT00408876|144618662|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||Repeated Measures|||||||0.001
72544595|NCT00408876|144618662|SUPERIORITY_OR_OTHER|||||||0.097||95.0|||||Repeated Measures|||||||0.097
72544596|NCT00408876|144618662|SUPERIORITY_OR_OTHER|||||||0.023||95.0|||||Repeated Measures|||||||0.023
72544597|NCT00408876|144618662|SUPERIORITY_OR_OTHER|||||||0.435||95.0|||||Repeated Measures|||||||0.435
72544598|NCT00408876|144618663|SUPERIORITY_OR_OTHER|||||||0.931||95.0|||||Repeated Measures|||||||0.931
72544599|NCT00408876|144618663|SUPERIORITY_OR_OTHER|||||||0.007||95.0|||||Repeated Measures|||||||0.007
72544600|NCT00408876|144618663|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Repeated Measures|||||||<0.001
72544601|NCT00408876|144618663|SUPERIORITY_OR_OTHER|||||||0.036||95.0|||||Repeated Measures|||||||0.036
72544602|NCT00408876|144618663|SUPERIORITY_OR_OTHER|||||||0.007||95.0|||||Repeated Measures|||||||0.007
72544603|NCT00408876|144618663|SUPERIORITY_OR_OTHER|||||||0.416||95.0|||||Repeated Measures|||||||0.416
72544604|NCT00408876|144618664|SUPERIORITY_OR_OTHER|||||||0.634||95.0|||||Repeated Measures|||||||0.634
72544605|NCT00408876|144618664|SUPERIORITY_OR_OTHER|||||||0.031||95.0|||||Repeated Measures|||||||0.031
72544606|NCT00408876|144618664|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||Repeated Measures|||||||0.002
72544607|NCT00408876|144618664|SUPERIORITY_OR_OTHER|||||||0.026||95.0|||||Repeated Measures|||||||0.026
72544608|NCT00408876|144618664|SUPERIORITY_OR_OTHER|||||||0.003||95.0|||||Repeated Measures|||||||0.003
72544609|NCT00408876|144618664|SUPERIORITY_OR_OTHER|||||||0.313||95.0|||||Repeated Measures|||||||0.313
72544610|NCT00408876|144618665|SUPERIORITY_OR_OTHER|||||||0.91||95.0|||||Repeated Measures|||||||0.910
72544611|NCT00408876|144618665|SUPERIORITY_OR_OTHER|||||||0.026||95.0|||||Repeated Measures|||||||0.026
72544612|NCT00408876|144618665|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Repeated Measures|||||||<0.001
72544613|NCT00408876|144618665|SUPERIORITY_OR_OTHER|||||||0.09||95.0|||||Repeated Measures|||||||0.090
72544614|NCT00408876|144618665|SUPERIORITY_OR_OTHER|||||||0.006||95.0|||||Repeated Measures|||||||0.006
72544615|NCT00408876|144618665|SUPERIORITY_OR_OTHER|||||||0.171||95.0|||||Repeated Measures|||||||0.171
72544616|NCT00408876|144618666|SUPERIORITY_OR_OTHER|||||||0.733||95.0|||||Repeated Measures|||||||0.733
72544617|NCT00408876|144618666|SUPERIORITY_OR_OTHER|||||||0.022||95.0|||||Repeated Measures|||||||0.022
72544618|NCT00408876|144618666|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Repeated Measures|||||||<0.001
72544619|NCT00408876|144618666|SUPERIORITY_OR_OTHER|||||||0.128||95.0|||||Repeated Measures|||||||0.128
72544620|NCT00408876|144618666|SUPERIORITY_OR_OTHER|||||||0.013||95.0|||||Repeated Measures|||||||0.013
72544621|NCT00408876|144618666|SUPERIORITY_OR_OTHER|||||||0.225||95.0|||||Repeated Measures|||||||0.225
72544622|NCT00408876|144618667|SUPERIORITY_OR_OTHER|||||||0.89||95.0|||||Repeated Measures|||||||0.890
72544623|NCT00408876|144618667|SUPERIORITY_OR_OTHER|||||||0.079||95.0|||||Repeated Measures|||||||0.079
72544624|NCT00408876|144618667|SUPERIORITY_OR_OTHER|||||||0.035||95.0|||||Repeated Measures|||||||0.035
72544625|NCT00408876|144618667|SUPERIORITY_OR_OTHER|||||||0.117||95.0|||||Repeated Measures|||||||0.117
72544626|NCT00408876|144618667|SUPERIORITY_OR_OTHER|||||||0.06||95.0|||||Repeated Measures|||||||0.060
72544627|NCT00408876|144618667|SUPERIORITY_OR_OTHER|||||||0.647||95.0|||||Repeated Measures|||||||0.647
72544628|NCT00408876|144618668|SUPERIORITY_OR_OTHER|||||||0.243||95.0|||||Repeated Measures|||||||0.243
72544629|NCT00408876|144618668|SUPERIORITY_OR_OTHER|||||||0.11||95.0|||||Repeated Measures|||||||0.110
72544630|NCT00408876|144618668|SUPERIORITY_OR_OTHER|||||||0.236||95.0|||||Repeated Measures|||||||0.236
72544631|NCT00408876|144618668|SUPERIORITY_OR_OTHER|||||||0.014||95.0|||||Repeated Measures|||||||0.014
72544632|NCT00408876|144618668|SUPERIORITY_OR_OTHER|||||||0.036||95.0|||||Repeated Measures|||||||0.036
72544633|NCT00408876|144618668|SUPERIORITY_OR_OTHER|||||||0.756||95.0|||||Repeated Measures|||||||0.756
72544634|NCT00408876|144618669|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.23||||0.465||95.0|-0.84|0.39|||t-test, 2 sided|||||0.39|-0.84|0.465
72544635|NCT00408876|144618669|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.79||||0.002||95.0|-1.3|-0.29|||t-test, 2 sided|||||-0.29|-1.30|0.002
72544636|NCT00408876|144618669|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.31||||0.233||95.0|-0.82|0.2|||t-test, 2 sided|||||0.20|-0.82|0.233
72544637|NCT00408876|144618669|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.56||||0.075||95.0|-1.19|0.06|||t-test, 2 sided|||||0.06|-1.19|0.075
72544638|NCT00408876|144618669|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.08||||0.798||95.0|-0.71|0.54|||t-test, 2 sided|||||0.54|-0.71|0.798
72544639|NCT00408876|144618669|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.48||||0.066||95.0|-0.03|1.0|||t-test, 2 sided|||||1.00|-0.03|0.066
72544640|NCT00408876|144618670|SUPERIORITY_OR_OTHER|||||||0.869||95.0|||||Fisher Exact|||||||0.869
72544641|NCT00408876|144618670|SUPERIORITY_OR_OTHER|||||||0.141||95.0|||||Fisher Exact|||||||0.141
72544642|NCT00408876|144618670|SUPERIORITY_OR_OTHER|||||||0.033||95.0|||||Fisher Exact|||||||0.033
72544643|NCT00408876|144618670|SUPERIORITY_OR_OTHER|||||||0.142||95.0|||||Fisher Exact|||||||0.142
72544644|NCT00408876|144618670|SUPERIORITY_OR_OTHER|||||||0.049||95.0|||||Fisher Exact|||||||0.049
72544645|NCT00408876|144618670|SUPERIORITY_OR_OTHER|||||||0.587||95.0|||||Fisher Exact|||||||0.587
72544646|NCT00408876|144618671|SUPERIORITY_OR_OTHER|||||||0.356||95.0|||||Fisher Exact|||||||0.356
72544647|NCT00408876|144618671|SUPERIORITY_OR_OTHER|||||||0.472||95.0|||||Fisher Exact|||||||0.472
72544648|NCT00408876|144618671|SUPERIORITY_OR_OTHER|||||||0.255||95.0|||||Fisher Exact|||||||0.255
72544649|NCT00408876|144618671|SUPERIORITY_OR_OTHER|||||||0.107||95.0|||||Fisher Exact|||||||0.107
72544650|NCT00408876|144618671|SUPERIORITY_OR_OTHER|||||||0.053||95.0|||||Fisher Exact|||||||0.053
72544651|NCT00408876|144618671|SUPERIORITY_OR_OTHER|||||||0.779||95.0|||||Fisher Exact|||||||0.779
72544652|NCT00408876|144618672|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.21||||0.747||95.0|-1.47|1.06|||t-test, 2 sided|||||1.06|-1.47|0.747
72544653|NCT00408876|144618672|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.07||||0.045||95.0|-2.12|-0.02|||t-test, 2 sided|||||-0.02|-2.12|0.045
72411404|NCT04079933|144331137|EQUIVALENCE|Null hypothesis = The Day 1(Weekly Recall) and Day 8 (Daily Tracking using IVRS) methods will have equivalent levels of change in mean exposure of carboxyhemoglobin; Alternate hypothesis = The Day 1(Weekly Recall) and Day 8 (Daily Tracking using IVRS) methods will NOT have equivalent levels of change from baseline to end of study in mean exposure of carboxyhemoglobin|Mean Difference (Net)|0.0||||0.944|TWO_SIDED|95.0|-0.2|0.2|||t-test, 2 sided|||Null hypothesis = The Day 1(Weekly Recall) and Day 8 (Daily Tracking using IVRS) methods will have equivalent levels of change in mean exposure of carboxyhemoglobin; Alternate hypothesis = The Day 1(Weekly Recall) and Day 8 (Daily Tracking using IVRS) methods will NOT have equivalent levels of change from baseline to end of study in mean exposure of carboxyhemoglobin||0.2|-0.2|0.9440
72544654|NCT00408876|144618672|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.3||||0.58||95.0|-0.76|1.36|||t-test, 2 sided|||||1.36|-0.76|0.580
72544655|NCT00408876|144618672|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.86||||0.185||95.0|-2.14|0.41|||t-test, 2 sided|||||0.41|-2.14|0.185
72544656|NCT00408876|144618672|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.51||||0.438||95.0|-0.77|1.79|||t-test, 2 sided|||||1.79|-0.77|0.438
72544657|NCT00408876|144618672|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.37||||0.012||95.0|0.3|2.44|||t-test, 2 sided|||||2.44|0.30|0.012
72544658|NCT00408876|144618673|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.46||||0.729||95.0|-2.16|3.08|||t-test, 2 sided|||||3.08|-2.16|0.729
72544659|NCT00408876|144618673|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.02||||0.352||95.0|-1.14|3.18|||t-test, 2 sided|||||3.18|-1.14|0.352
72544660|NCT00408876|144618673|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.81||||0.465||95.0|-3.0|1.37|||t-test, 2 sided|||||1.37|-3.00|0.465
72544661|NCT00408876|144618673|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.56||||0.677||95.0|-2.09|3.21|||t-test, 2 sided|||||3.21|-2.09|0.677
72544662|NCT00408876|144618673|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.27||||0.345||95.0|-3.92|1.38|||t-test, 2 sided|||||1.38|-3.92|0.345
72544663|NCT00408876|144618673|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.84||||0.102||95.0|-4.04|0.37|||t-test, 2 sided|||||0.37|-4.04|0.102
72544664|NCT00408876|144618674|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.04||||0.977||95.0|-2.91|2.83|||t-test, 2 sided|||||2.83|-2.91|0.977
72544665|NCT00408876|144618674|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.9||||0.451||95.0|-1.44|3.24|||t-test, 2 sided|||||3.24|-1.44|0.451
72544666|NCT00408876|144618674|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.74||||0.15||95.0|-0.63|4.11|||t-test, 2 sided|||||4.11|-0.63|0.150
72544667|NCT00408876|144618674|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.94||||0.524||95.0|-1.96|3.83|||t-test, 2 sided|||||3.83|-1.96|0.524
72544668|NCT00408876|144618674|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.78||||0.23||95.0|-1.13|4.69|||t-test, 2 sided|||||4.69|-1.13|0.230
72544669|NCT00408876|144618674|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.84||||0.491||95.0|-1.55|3.23|||t-test, 2 sided|||||3.23|-1.55|0.491
72544670|NCT00408876|144618675|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.15||||0.645||95.0|-0.49|0.79|||t-test, 2 sided|||||0.79|-0.49|0.645
72544671|NCT00408876|144618675|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.6||||0.027||95.0|0.07|1.12|||t-test, 2 sided|||||1.12|0.07|0.027
72544672|NCT00408876|144618675|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.75||||0.006||95.0|0.22|1.29|||t-test, 2 sided|||||1.29|0.22|0.006
72544673|NCT00408876|144618675|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.44||||0.18||95.0|-0.21|1.1|||t-test, 2 sided|||||1.10|-0.21|0.180
72544674|NCT00408876|144618675|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.6||||0.069||95.0|-0.05|1.25|||t-test, 2 sided|||||1.25|-0.05|0.069
72544675|NCT00408876|144618675|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.16||||0.564||95.0|-0.38|0.7|||t-test, 2 sided|||||0.70|-0.38|0.564
72544676|NCT00408876|144618676|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.04||||0.929||95.0|-0.92|1.0|||t-test, 2 sided|||||1.00|-0.92|0.929
72544677|NCT00408876|144618676|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.58||||0.147||95.0|-0.21|1.36|||t-test, 2 sided|||||1.36|-0.21|0.147
72544678|NCT00408876|144618676|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.16||||0.7||95.0|-0.64|0.95|||t-test, 2 sided|||||0.95|-0.64|0.700
72544679|NCT00408876|144618676|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.54||||0.279||95.0|-0.44|1.51|||t-test, 2 sided|||||1.51|-0.44|0.279
72544680|NCT00408876|144618676|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.11||||0.822||95.0|-0.86|1.09|||t-test, 2 sided|||||1.09|-0.86|0.822
72544681|NCT00408876|144618676|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.42||||0.299||95.0|-1.22|0.38|||t-test, 2 sided|||||0.38|-1.22|0.299
72544682|NCT00408876|144618677|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.18||||0.766||95.0|-1.33|0.98|||t-test, 2 sided|||||0.98|-1.33|0.766
72544683|NCT00408876|144618677|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.6||||0.217||95.0|-0.35|1.55|||t-test, 2 sided|||||1.55|-0.35|0.217
72544684|NCT00408876|144618677|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.07||||0.88||95.0|-0.89|1.04|||t-test, 2 sided|||||1.04|-0.89|0.880
72544685|NCT00408876|144618677|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.78||||0.193||95.0|-0.39|1.94|||t-test, 2 sided|||||1.94|-0.39|0.193
72544686|NCT00408876|144618677|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.25||||0.675||95.0|-0.92|1.42|||t-test, 2 sided|||||1.42|-0.92|0.675
72544687|NCT00408876|144618677|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.53||||0.288||95.0|-1.5|0.45|||t-test, 2 sided|||||0.45|-1.50|0.288
72544688|NCT00408876|144618678|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.42||||0.501||95.0|-1.66|0.81|||t-test, 2 sided|||||0.81|-1.66|0.501
72544689|NCT00408876|144618678|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.33||||0.524||95.0|-0.69|1.35|||t-test, 2 sided|||||1.35|-0.69|0.524
72544690|NCT00408876|144618678|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.89||||0.089||95.0|-0.14|1.91|||t-test, 2 sided|||||1.91|-0.14|0.089
72544691|NCT00408876|144618678|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.75||||0.234||95.0|-0.49|2.0|||t-test, 2 sided|||||2.00|-0.49|0.234
72544692|NCT00408876|144618678|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.31||||0.04||95.0|0.06|2.56|||t-test, 2 sided|||||2.56|0.06|0.040
72544693|NCT00408876|144618678|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.56||||0.289||95.0|-0.48|1.59|||t-test, 2 sided|||||1.59|-0.48|0.289
72544694|NCT00408876|144618679|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.03||||0.862||95.0|-0.27|0.32|||t-test, 2 sided|||||0.32|-0.27|0.862
72544695|NCT00408876|144618679|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.11||||0.368||95.0|-0.13|0.35|||t-test, 2 sided|||||0.35|-0.13|0.368
72544696|NCT00408876|144618679|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.06||||0.628||95.0|-0.18|0.31|||t-test, 2 sided|||||0.31|-0.18|0.628
72544697|NCT00408876|144618679|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.09||||0.573||95.0|-0.21|0.38|||t-test, 2 sided|||||0.38|-0.21|0.573
72544698|NCT00408876|144618679|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.03||||0.819||95.0|-0.26|0.33|||t-test, 2 sided|||||0.33|-0.26|0.819
72544699|NCT00408876|144618679|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.05||||0.687||95.0|-0.3|0.2|||t-test, 2 sided|||||0.20|-0.30|0.687
72544700|NCT00408876|144618680|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.01||||0.972||95.0|-0.48|0.5|||t-test, 2 sided|||||0.50|-0.48|0.972
72544701|NCT00408876|144618680|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0||||0.99||95.0|-0.4|0.4|||t-test, 2 sided|||||0.40|-0.40|0.990
72544702|NCT00408876|144618680|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.05||||0.793||95.0|-0.35|0.46|||t-test, 2 sided|||||0.46|-0.35|0.793
72544703|NCT00408876|144618680|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.01||||0.981||95.0|-0.5|0.49|||t-test, 2 sided|||||0.49|-0.50|0.981
72544704|NCT00408876|144618680|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.05||||0.857||95.0|-0.45|0.54|||t-test, 2 sided|||||0.54|-0.45|0.857
72544705|NCT00408876|144618680|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.05||||0.805||95.0|-0.36|0.46|||t-test, 2 sided|||||0.46|-0.36|0.805
72544706|NCT00408876|144618681|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.24||||0.34||95.0|-0.26|0.75|||t-test, 2 sided|||||0.75|-0.26|0.340
72544707|NCT00408876|144618681|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.04||||0.848||95.0|-0.45|0.37|||t-test, 2 sided|||||0.37|-0.45|0.848
72544708|NCT00408876|144618681|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.12||||0.573||95.0|-0.54|0.3|||t-test, 2 sided|||||0.30|-0.54|0.573
72544709|NCT00408876|144618681|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.29||||0.272||95.0|-0.79|0.22|||t-test, 2 sided|||||0.22|-0.79|0.272
72544710|NCT00408876|144618681|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.36||||0.161||95.0|-0.88|0.15|||t-test, 2 sided|||||0.15|-0.88|0.161
72544711|NCT00408876|144618681|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.08||||0.711||95.0|-0.5|0.34|||t-test, 2 sided|||||0.34|-0.50|0.711
72544712|NCT00408876|144618682|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.22||||0.713||95.0|-1.39|0.95|||t-test, 2 sided|||||0.95|-1.39|0.713
72544713|NCT00408876|144618682|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.52||||0.288||95.0|-0.44|1.49|||t-test, 2 sided|||||1.49|-0.44|0.288
72544714|NCT00408876|144618682|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.46||||0.351||95.0|-1.44|0.51|||t-test, 2 sided|||||0.51|-1.44|0.351
72544715|NCT00408876|144618682|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.74||||0.219||95.0|-0.44|1.93|||t-test, 2 sided|||||1.93|-0.44|0.219
72544716|NCT00408876|144618682|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.24||||0.686||95.0|-1.43|0.94|||t-test, 2 sided|||||0.94|-1.43|0.686
72544717|NCT00408876|144618682|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.98||||0.05||95.0|-1.97|0.0|||t-test, 2 sided|||||0.00|-1.97|0.050
72544718|NCT00408876|144618683|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.01||||0.663||95.0|-0.06|0.04|||t-test, 2 sided|||||0.04|-0.06|0.663
72544719|NCT00408876|144618683|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.02||||0.33||95.0|-0.02|0.06|||t-test, 2 sided|||||0.06|-0.02|0.330
72544720|NCT00408876|144618683|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.03||||0.143||95.0|-0.01|0.07|||t-test, 2 sided|||||0.07|-0.01|0.143
72579185|NCT03126435|144686546|SUPERIORITY|||||||0.9882|||||||Regression, Logistic|P-value is from logistic regression model adjusted for stratification factors among non-missing records.||||||0.9882
72579186|NCT01023035|144686550|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.7|||||TWO_SIDED|95.0|-8.6|7.2|||Mantel-Haenszel, modified Koch method|||The modified Koch method was used to calculate the stratum-adjusted Mantel-Haenszel (MH) difference between the SVR rates for the Erythropoietin Use Arm versus the Ribavirin Dose Reduction Arm and corresponding 95% confidence interval with continuity correction.||7.2|-8.6|
72579187|NCT03127514|144686562|SUPERIORITY|||||||0.03||||||A two-tailed P value of 0.05 or less was considered to indicate statistical significance.|Mixed Models Analysis|Random-slope, shared-baseline, linear mixed model was adjusted for age and prebaseline ALSFRS-R slope||||||0.03
72579188|NCT02413229|144686582|SUPERIORITY|||||||0.3571|||||||Cochran-Mantel-Haenszel|||||||0.3571
72579189|NCT02413229|144686582|SUPERIORITY|||||||0.5224|||||||Cochran-Mantel-Haenszel|||||||0.5224
72579190|NCT02413229|144686582|SUPERIORITY|||||||0.389|||||||Cochran-Mantel-Haenszel|||||||0.3890
72579191|NCT02413229|144686582|SUPERIORITY|||||||0.0325|||||||Cochran-Mantel-Haenszel|||||||.0325
72579192|NCT00699816|144686584|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.63||||0.01|TWO_SIDED|95.0|0.43|0.94|||Log Rank|||||0.94|0.43|0.01
72579193|NCT00699816|144686585|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.21||||0.008|TWO_SIDED|95.0|0.06|0.75|||Log Rank|||||0.75|0.06|0.008
72579194|NCT00699816|144686586|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.19||||0.02|TWO_SIDED|95.0|0.04|0.87|||Log Rank|||||0.87|0.04|0.02
72579195|NCT01526655|144686591|SUPERIORITY|||||||0.011||||||Main effect over time p\<0.001; Interaction effect p=0.65. Threshold for statistical significance p\<0.05|ANOVA|||||||0.011
72579196|NCT01526655|144686592|SUPERIORITY|||||||0.03||||||"P-value main effect between groups. Effect over time p \< 0.0001. Interaction effect p 0.02.~Threshold for statistical significance p\<0.05."|ANOVA||||Tukey post hoc test (p-values): hsCRP time 4 p 0.02; hsCRP time 5 p \<0.001.|||0.03
72579197|NCT01526655|144686593|SUPERIORITY||||||<|0.01||||||"P-value main effect between groups. Effect over time p \< 0.0001. Interaction effect p \< 0.0001.~Threshold for statistical significance p \< 0.05."|ANOVA||||Tukey post hoc test (p-value): WBC time 3 p \< 0.0001.|||<0.01
72579198|NCT01526655|144686594|SUPERIORITY|||||||0.03|||||||ANOVA||||Tukey post hoc test (p-value): IL-6 time 3 p \< 0.01.|||0.03
72579199|NCT01526655|144686595|SUPERIORITY|||||||0.03||||||"P-value main effect between groups. Effect over time p \< 0.0001. Interaction effect p \< 0.01.~Threshold for statistical significance p \< 0.05."|ANOVA||||Tukey post hoc test (p-value): CK time 4 p \< 0.0001.|||0.03
72579200|NCT01526655|144686596|SUPERIORITY|||||||0.06||||||"P-value main effect between groups. Effect over time p \< 0.0001. Interaction effect p \< 0.01.~Threshold for statistical significance p \< 0.05."|ANOVA||||Tukey post hoc test (p-value): cortisol time 3 p \< 0.0001.|||0.06
72579201|NCT01526655|144686597|SUPERIORITY|||||||0.06|||||||t-test, 2 sided|||||||0.06
72579202|NCT01526655|144686598|SUPERIORITY|||||||0.04|||||||t-test, 2 sided|||||||0.04
72579203|NCT04020887|144686606|SUPERIORITY||Median Difference (Final Values)|6.0|||||TWO_SIDED|95.0|-6.01|18.01||||||Difference in time to PACU discharge determination from observation to interaction phase \[ Time Frame: 6 months\]: The difference in discharge readiness time between the observation and interaction phases will be compared.||18.01|-6.01|
72579204|NCT04020887|144686607|SUPERIORITY||Difference Between Proportions|29.8|||||TWO_SIDED|95.0|23.82|35.66||||||||35.66|23.82|
72579205|NCT04020887|144686608|SUPERIORITY||Difference Between Proportions|-2.67|||||TWO_SIDED|95.0|-8.18|3.02||||||||3.02|-8.18|
72579206|NCT04020887|144686609|SUPERIORITY||Difference Between Proportions|13.03|||||TWO_SIDED|95.0|5.16|20.79||||||||20.79|5.16|
72579207|NCT04020887|144686610|SUPERIORITY||Difference Between Proportions|0.51|||||TWO_SIDED|95.0|-1.63|3.07||||||||3.07|-1.63|
72579208|NCT04020887|144686611|SUPERIORITY||Difference Between Proportions|7.9|||||TWO_SIDED|95.0|3.13|12.71||||||||12.71|3.13|
72579209|NCT02374346|144686716|NON_INFERIORITY_OR_EQUIVALENCE|Associations between categorical variables were tested by χ2 test, while differences between categorical and continuous variables were tested by Student's t test. Univariate analysis was performed with the computation of unadjusted odds ratios with 95% confidence intervals. A stepwise multiple logistic regression analysis was conducted to find independent factors.|Odds Ratio (OR)|3.23||||0.001|TWO_SIDED|95.0|2.04|5.13|||t-test, 2 sided|||Sevoflurane administration in developing postoperative headache||5.13|2.04|0.001
72579210|NCT02374346|144686716|NON_INFERIORITY_OR_EQUIVALENCE|Associations between categorical variables were tested by χ2 test, while differences between categorical and continuous variables were tested by Student's t test. Univariate analysis was performed with the computation of unadjusted odds ratios with 95% confidence intervals. A stepwise multiple logistic regression analysis was conducted to find independent factors.|Odds Ratio (OR)|1.85||||0.006|TWO_SIDED|95.0|1.19|2.84|||t-test, 2 sided|||Smoking as a factor for developing postoperative headache||2.84|1.19|0.006
72579211|NCT02374346|144686716|NON_INFERIORITY_OR_EQUIVALENCE|Associations between categorical variables were tested by χ2 test, while differences between categorical and continuous variables were tested by Student's t test. Univariate analysis was performed with the computation of unadjusted odds ratios with 95% confidence intervals. A stepwise multiple logistic regression analysis was conducted to find independent factors.|Odds Ratio (OR)|2.11||||0.008|TWO_SIDED|95.0|1.22|3.66|||t-test, 2 sided|||Intraoperative hypotension associated with postoperative headache in total sample||3.66|1.22|0.008
72579212|NCT02374346|144686716|NON_INFERIORITY_OR_EQUIVALENCE|Associations between categorical variables were tested by χ2 test, while differences between categorical and continuous variables were tested by Student's t test. Univariate analysis was performed with the computation of unadjusted odds ratios with 95% confidence intervals. A stepwise multiple logistic regression analysis was conducted to find independent factors.|Odds Ratio (OR)|1.85||||0.024|TWO_SIDED|95.0|1.08|3.15|||t-test, 2 sided|||Female gender as a factor for developing postoperative headache||3.15|1.08|0.024
72579213|NCT02374346|144686716|NON_INFERIORITY_OR_EQUIVALENCE|Associations between categorical variables were tested by χ2 test, while differences between categorical and continuous variables were tested by Student's t test. Univariate analysis was performed with the computation of unadjusted odds ratios with 95% confidence intervals. A stepwise multiple logistic regression analysis was conducted to find independent factors.|Odds Ratio (OR)|4.56||||0.005|TWO_SIDED|95.0|1.58|13.17|||t-test, 2 sided|||Association of female gender and postoperative headache||13.17|1.58|0.005
72411405|NCT04079933|144331138|EQUIVALENCE|Null hypothesis = The Day 1(Weekly Recall) and Day 8 (Daily Tracking using IVRS) methods will have equivalent levels of change in mean exposure of carbon monoxide; Alternate hypothesis = The Day 1(Weekly Recall) and Day 8 (Daily Tracking using IVRS) methods will NOT have equivalent levels of change from baseline to end of study in mean exposure of carbon monoxide|Mean Difference (Net)|0.0||||0.7484|TWO_SIDED|95.0|-1.0|1.0|||t-test, 2 sided|||Null hypothesis = The Day 1(Weekly Recall) and Day 8 (Daily Tracking using IVRS) methods will have equivalent levels of change in mean exposure of carbon monoxide; Alternate hypothesis = The Day 1(Weekly Recall) and Day 8 (Daily Tracking using IVRS) methods will NOT have equivalent levels of change from baseline to end of study in mean exposure of carbon monoxide||1|-1|0.7484
72411406|NCT04079933|144331139|EQUIVALENCE|Null hypothesis = Cigarette consumption (CPD) determined using the Day 1 (Weekly Recall) and Day 8 (Daily Tracking using IVRS) methods will be equivalent; Alternate hypothesis = Cigarette consumption (CPD) determined using the Day 1(Weekly Recall) and Day 8 (Daily Tracking using IVRS) methods will NOT be equivalent|Mean Difference (Net)|0.0||||0.9992|TWO_SIDED|95.0|0.0|0.0|||t-test, 2 sided|||Null hypothesis = Cigarette consumption (CPD) determined using the Day 1 (Weekly Recall) and Day 8 (Daily Tracking using IVRS) methods will be equivalent; Alternate hypothesis = Cigarette consumption (CPD) determined using the Day 1(Weekly Recall) and Day 8 (Daily Tracking using IVRS) methods will NOT be equivalent||0|0|0.9992
72411407|NCT04079933|144331161|EQUIVALENCE|Null hypothesis = Test and Control groups will have equivalent number of subjects in subgroups based on urinary total NNAL change from baseline to end of study; Alternate hypothesis = Test and Control groups will NOT have equivalent number of subjects in subgroups based on urinary total NNAL change from baseline to end of study|Probability|0.1661||||0.1661|TWO_SIDED||||||Cochran-Mantel-Haenszel||Estimated value is the probability of observed distribution assuming the null hypothesis|Null hypothesis = Test and Control groups will have equivalent number of subjects in subgroups based on urinary total NNAL change from baseline to end of study; Alternate hypothesis = Test and Control groups will NOT have equivalent number of subjects in subgroups based on urinary total NNAL change from baseline to end of study||||0.1661
72544721|NCT00408876|144618683|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.03||||0.218||95.0|-0.02|0.08|||t-test, 2 sided|||||0.08|-0.02|0.218
72544722|NCT00408876|144618683|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.04||||0.1||95.0|-0.01|0.09|||t-test, 2 sided|||||0.09|-0.01|0.100
72544723|NCT00408876|144618683|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.01||||0.614||95.0|-0.03|0.05|||t-test, 2 sided|||||0.05|-0.03|0.614
72544724|NCT00408876|144618684|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.22||||0.786||95.0|-1.83|1.39|||t-test, 2 sided|||||1.39|-1.83|0.786
72544725|NCT00408876|144618684|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.52||||0.445||95.0|-1.85|0.81|||t-test, 2 sided|||||0.81|-1.85|0.445
72544726|NCT00408876|144618684|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.39||||0.043||95.0|0.04|2.74|||t-test, 2 sided|||||2.74|0.04|0.043
72544727|NCT00408876|144618684|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.3||||0.721||95.0|-1.92|1.33|||t-test, 2 sided|||||1.33|-1.92|0.721
72544728|NCT00408876|144618684|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.61||||0.053||95.0|-0.02|3.24|||t-test, 2 sided|||||3.24|-0.02|0.053
72544729|NCT00408876|144618684|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.91||||0.006||95.0|0.54|3.27|||t-test, 2 sided|||||3.27|0.54|0.006
72544730|NCT00408876|144618685|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.39||||0.378||95.0|-0.48|1.25|||t-test, 2 sided|||||1.25|-0.48|0.378
72544731|NCT00408876|144618685|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.13||||0.723||95.0|-0.84|0.59|||t-test, 2 sided|||||0.59|-0.84|0.723
72544732|NCT00408876|144618685|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.22||||0.542||95.0|-0.95|0.5|||t-test, 2 sided|||||0.50|-0.95|0.542
72544733|NCT00408876|144618685|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.52||||0.245||95.0|-1.39|0.36|||t-test, 2 sided|||||0.36|-1.39|0.245
72544734|NCT00408876|144618685|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.61||||0.169||95.0|-1.48|0.26|||t-test, 2 sided|||||0.26|-1.48|0.169
72544735|NCT00408876|144618685|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1||||0.796||95.0|-0.82|0.63|||t-test, 2 sided|||||0.63|-0.82|0.796
72544736|NCT00408876|144618687|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||||||<0.001
72544737|NCT00408876|144618687|SUPERIORITY_OR_OTHER|||||||0.015||95.0|||||t-test, 2 sided|||||||0.015
72544738|NCT00408876|144618687|SUPERIORITY_OR_OTHER|||||||0.015||95.0|||||t-test, 2 sided|||||||0.015
72544739|NCT00408876|144618688|SUPERIORITY_OR_OTHER|||||||0.039||95.0|||||t-test, 2 sided|||||||0.039
72544740|NCT00408876|144618689|SUPERIORITY_OR_OTHER|||||||0.048||95.0|||||t-test, 2 sided|||||||0.048
72544741|NCT00408876|144618690|SUPERIORITY_OR_OTHER|||||||0.015||95.0|||||t-test, 2 sided|||||||0.015
72544742|NCT00408876|144618690|SUPERIORITY_OR_OTHER|||||||0.046||95.0|||||t-test, 2 sided|||||||0.046
72544743|NCT00408876|144618691|SUPERIORITY_OR_OTHER|||||||0.039||95.0|||||t-test, 2 sided|||||||0.039
72544744|NCT00408876|144618692|SUPERIORITY_OR_OTHER|||||||0.042||95.0|||||t-test, 2 sided|||||||0.042
72544745|NCT00408876|144618693|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||||||<0.001
72544746|NCT00408876|144618694|SUPERIORITY_OR_OTHER|||||||0.031||95.0|||||t-test, 2 sided|||||||0.031
72544747|NCT00408876|144618695|SUPERIORITY_OR_OTHER|||||||0.03||95.0|||||t-test, 2 sided|||||||0.030
72544748|NCT00408876|144618696|SUPERIORITY_OR_OTHER|||||||0.005||95.0|||||t-test, 2 sided|||||||0.005
72544749|NCT00408876|144618696|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||||||<0.001
72544750|NCT00408876|144618696|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||t-test, 2 sided|||||||0.001
72544751|NCT00408876|144618697|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.38||||0.348||95.0|-4.28|1.51|||t-test, 2 sided|||||1.51|-4.28|0.348
72544752|NCT00408876|144618697|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.5||||0.04||95.0|0.11|4.89|||t-test, 2 sided|||||4.89|0.11|0.040
72411408|NCT04079933|144331161|EQUIVALENCE|Null hypothesis = Test and Control groups will have equivalent number of subjects in subgroups based on urinary total NNAL change from baseline to end of study; Alternate hypothesis = Test and Control groups will NOT have equivalent number of subjects in subgroups based on urinary total NNAL change from baseline to end of study|Probability|0.2139||||0.2139|TWO_SIDED||||||Fisher Exact||Estimated value is the probability of observed distribution assuming the null hypothesis|Null hypothesis = Test and Control groups will have equivalent number of subjects in subgroups based on urinary total NNAL change from baseline to end of study; Alternate hypothesis = Test and Control groups will NOT have equivalent number of subjects in subgroups based on urinary total NNAL change from baseline to end of study||||0.2139
72544753|NCT00408876|144618697|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.61||||0.191||95.0|-0.81|4.03|||t-test, 2 sided|||||4.03|-0.81|0.191
72544754|NCT00408876|144618697|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.89||||0.009||95.0|0.97|6.8|||t-test, 2 sided|||||6.80|0.97|0.009
72544755|NCT00408876|144618697|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.0||||0.044||95.0|0.08|5.91|||t-test, 2 sided|||||5.91|0.08|0.044
72544756|NCT00408876|144618697|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.89||||0.473||95.0|-3.33|1.55|||t-test, 2 sided|||||1.55|-3.33|0.473
72544757|NCT00408876|144618698|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.4||||0.846||95.0|-3.61|4.4|||t-test, 2 sided|||||4.40|-3.61|0.846
72544758|NCT00408876|144618698|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.14||||0.934||95.0|-3.45|3.17|||t-test, 2 sided|||||3.17|-3.45|0.934
72544759|NCT00408876|144618698|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.03||||0.234||95.0|-1.32|5.39|||t-test, 2 sided|||||5.39|-1.32|0.234
72544760|NCT00408876|144618698|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.54||||0.794||95.0|-4.58|3.5|||t-test, 2 sided|||||3.50|-4.58|0.794
72544761|NCT00408876|144618698|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.64||||0.426||95.0|-2.4|5.67|||t-test, 2 sided|||||5.67|-2.40|0.426
72544762|NCT00408876|144618698|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.17||||0.207||95.0|-1.21|5.55|||t-test, 2 sided|||||5.55|-1.21|0.207
72544763|NCT00408876|144618699|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.17||||0.901||95.0|-2.54|2.89|||t-test, 2 sided|||||2.89|-2.54|0.901
72544764|NCT00408876|144618699|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.11||||0.926||95.0|-2.35|2.14|||t-test, 2 sided|||||2.14|-2.35|0.926
72544765|NCT00408876|144618699|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.62||||0.002||95.0|1.35|5.9|||t-test, 2 sided|||||5.90|1.35|0.002
72544766|NCT00408876|144618699|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.28||||0.841||95.0|-3.02|2.46|||t-test, 2 sided|||||2.46|-3.02|0.841
72544767|NCT00408876|144618699|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.45||||0.014||95.0|0.71|6.19|||t-test, 2 sided|||||6.19|0.71|0.014
72544768|NCT00408876|144618699|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.73||||0.001||95.0|1.44|6.02|||t-test, 2 sided|||||6.02|1.44|0.001
72544769|NCT00408876|144618700|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.7||||0.057||95.0|-1.41|0.02|||t-test, 2 sided|||||0.02|-1.41|0.057
72544770|NCT00408876|144618700|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.46||||0.128||95.0|-1.05|0.13|||t-test, 2 sided|||||0.13|-1.05|0.128
72544771|NCT00408876|144618700|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.82||||0.007||95.0|-1.42|-0.22|||t-test, 2 sided|||||-0.22|-1.42|0.007
72544772|NCT00408876|144618700|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.24||||0.518||95.0|-0.48|0.96|||t-test, 2 sided|||||0.96|-0.48|0.518
72544773|NCT00408876|144618700|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.12||||0.734||95.0|-0.85|0.6|||t-test, 2 sided|||||0.60|-0.85|0.734
72544774|NCT00408876|144618700|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.36||||0.239||95.0|-0.97|0.24|||t-test, 2 sided|||||0.24|-0.97|0.239
72411409|NCT01731171|144331216|OTHER|The effect of treatment was calculated using logistic regression and the Cox proportional hazard function employing age, gender, and race as covariates.|Cox Proportional Hazard|0.37|||=|0.029|TWO_SIDED|95.0|||||Regression, Logistic||Values less than one favor adjunctive probiotic treatment, while values higher than one favor the placebo.|||||=.029
72411410|NCT01731171|144331217|SUPERIORITY||||||=|0.022|||||||Chi-squared|||||||=.022
72411411|NCT01731171|144331218|SUPERIORITY||||||=|0.009|||||||Regression, Linear|||||||=.009
72411412|NCT01731171|144331219|SUPERIORITY||||||=|0.017|||||||Kruskal-Wallis|||||||=.017
72411413|NCT01736852|144331226|NON_INFERIORITY|non-inferiority margin of 10%, α = 0.025, power = 0.80,||||||0.06|||||||Fisher Exact|||.ample size calculations were performed using an expected rate of 4% for each group,a one-sided exact test, α = 0.025, power = 0.80, non-inferiority margin of 10% resulting in a sample size of 124 patients or 62 patients per treatment arm.||||0.06
72411414|NCT03207750|144331227|NON_INFERIORITY|Lower limit (LL) of the two-sided asymptotic standardized 95% Confidence Interval (CI) for the difference in seroprotective concentration (HRV PCV-free Liquid group minus HRV Lyophilized group) for each of anti-D antibodies should be ≥-10%.|Difference in anti-D concentration|0.0|||||TWO_SIDED|95.0|-0.8|0.79||||||Non-inferiority of the immune responses to 3 doses of Pediarix, Hiberix and Prevenar 13 when co-administered with 2 doses of the PCV-free liquid HRV vaccine, as compared to when co-administered with lyophilized HRV vaccine in terms of group difference in percentage of subjects with seroprotective concentrations (≥ 0.1 IU/mL) of anti-D antibodies.||0.79|-0.80|
72411415|NCT03207750|144331227|NON_INFERIORITY|Lower limit (LL) of the two-sided asymptotic standardized 95% Confidence Interval (CI) for the difference in seroprotective concentration (HRV PCV-free Liquid group minus HRV Lyophilized group) for each of anti-T antibodies should be ≥-10%.|Difference in anti-T concentration|0.0|||||TWO_SIDED|95.0|-0.79|0.77||||||Non-inferiority of the immune responses to 3 doses of Pediarix, Hiberix and Prevenar 13 when co-administered with 2 doses of the PCV-free liquid HRV vaccine, as compared to when co-administered with lyophilized HRV vaccine in terms of group difference in percentage of subjects with seroprotective concentrations (≥ 0.1 IU/mL) of anti-T antibodies.||0.77|-0.79|
72579214|NCT02374346|144686716|NON_INFERIORITY_OR_EQUIVALENCE|Associations between categorical variables were tested by χ2 test, while differences between categorical and continuous variables were tested by Student's t test. Univariate analysis was performed with the computation of unadjusted odds ratios with 95% confidence intervals. A stepwise multiple logistic regression analysis was conducted to find independent factors.|Odds Ratio (OR)|3.79||||0.006|TWO_SIDED|95.0|1.48|9.72|||t-test, 2 sided|||Association of intraoperative hypotension and postoperative headache||9.72|1.48|0.006
72579215|NCT02374346|144686716|NON_INFERIORITY_OR_EQUIVALENCE|Associations between categorical variables were tested by χ2 test, while differences between categorical and continuous variables were tested by Student's t test. Univariate analysis was performed with the computation of unadjusted odds ratios with 95% confidence intervals. A stepwise multiple logistic regression analysis was conducted to find independent factors.|Odds Ratio (OR)|3.86||||0.041|TWO_SIDED|95.0|1.06|14.06|||t-test, 2 sided|||Association of caffeine consumption and postoperative headache||14.06|1.06|0.041
72579216|NCT02374346|144686716|NON_INFERIORITY_OR_EQUIVALENCE|Associations between categorical variables were tested by χ2 test, while differences between categorical and continuous variables were tested by Student's t test.Univariate analysis was performed with the computation of unadjusted odds ratios with 95% confidence intervals. A stepwise multiple logistic regression analysis was conducted to find independent factors.|Odds Ratio (OR)|4.26||||0.001|TWO_SIDED|95.0|1.82|9.95|||t-test, 2 sided|||Association of sevoflurane administration and postoperative headache||9.95|1.82|0.001
72579217|NCT04807400|144686717|SUPERIORITY||Least Squares Mean|-31.8|STANDARD_ERROR_OF_MEAN|3.1|<|0.001|TWO_SIDED|95.0|-37.91|-25.77||p-values are adjusted using Holm's procedure.|ANCOVA|||||-25.77|-37.91|<0.001
72579218|NCT04807400|144686717|SUPERIORITY||Least Squares Mean|-32.1|STANDARD_ERROR_OF_MEAN|3.17|<|0.001|TWO_SIDED|95.0|-38.35|-25.94||p-values are adjusted using Holm's procedure.|ANCOVA|||||-25.94|-38.35|<0.001
72579219|NCT04807400|144686719|SUPERIORITY||Least-squares Mean|1.4|STANDARD_ERROR_OF_MEAN|0.39|<|0.001|TWO_SIDED|95.0|0.62|2.13|||ANOVA|||||2.13|0.62|<0.001
72579220|NCT04807400|144686719|SUPERIORITY||Least-squares Mean|1.3|STANDARD_ERROR_OF_MEAN|0.38|<|0.001|TWO_SIDED|95.0|0.6|2.1|||ANOVA|||||2.10|0.60|<0.001
72579221|NCT04807400|144686720|SUPERIORITY||Least-squares Mean|-0.03|STANDARD_ERROR_OF_MEAN|0.326||0.9347|TWO_SIDED|95.0|-0.67|0.61|||ANOVA|||||0.61|-0.67|0.9347
72579222|NCT04807400|144686721|SUPERIORITY||Least-squares Mean|1.0|STANDARD_ERROR_OF_MEAN|2.34||0.6759|TWO_SIDED|95.0|-3.62|5.58|||ANCOVA|||||5.58|-3.62|0.6759
72579223|NCT04807400|144686721|SUPERIORITY||Least-squares Mean|1.3|STANDARD_ERROR_OF_MEAN|2.31||0.5756|TWO_SIDED|95.0|-3.25|5.84|||ANCOVA|||||5.84|-3.25|0.5756
72579224|NCT04807400|144686722|SUPERIORITY||Least-squares Mean|0.3|STANDARD_ERROR_OF_MEAN|1.69||0.858|TWO_SIDED|95.0|-3.02|3.62|||ANCOVA|||||3.62|-3.02|0.8580
72579225|NCT01330303|144686733|NON_INFERIORITY_OR_EQUIVALENCE|This is a bioequivalence study performed to support the register of tamsulosin hydrochloride, produced by Synthon BV, as a branded generic, to be marketed by GlaxoSmithKline Brasil Ltda., according to the requirements of the Brazilian Regulatory Agency - National Agency of Sanitary Surveillance (ANVISA).|Ratio T formulation/R formulation|101.89||||||90.0|94.91|109.39|||||The ratios between the geometric means of the test (T) and reference (R) formulations were calculated.|||109.39|94.91|
72579226|NCT01330303|144686734|NON_INFERIORITY_OR_EQUIVALENCE|This is a bioequivalence study performed to support the register of tamsulosin hydrochloride, produced by Synthon BV, as a branded generic, to be marketed by GlaxoSmithKline Brasil Ltda., according to the requirements of the Brazilian Regulatory Agency - National Agency of Sanitary Surveillance (ANVISA).|Ratio T formulation/R formulation|101.91||||||90.0|95.0|109.33|||||The ratios between the geometric means of the test (T) and reference (R) formulations were calculated.|||109.33|95.00|
72579227|NCT01330303|144686735|NON_INFERIORITY_OR_EQUIVALENCE|This is a bioequivalence study performed to support the register of tamsulosin hydrochloride, produced by Synthon BV, as a branded generic, to be marketed by GlaxoSmithKline Brasil Ltda., according to the requirements of the Brazilian Regulatory Agency - National Agency of Sanitary Surveillance (ANVISA).|Ratio T formulation/R formulation|94.04||||||90.0|86.33|102.44|||||The ratios between the geometric means of the test (T) and reference (R) formulations were calculated.|||102.44|86.33|
72579228|NCT00125515|144686782|SUPERIORITY_OR_OTHER|||||||0.32|TWO_SIDED|95.0|||||Chi-squared|||all statistical analysis were two tailed and employed an alpha significance level of 0.05.||||0.32
72579229|NCT00207883|144686784|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Fisher Exact|||||||<0.001
72579230|NCT02359994|144686786|NON_INFERIORITY|Non-inferiority was assessed with a pre-specified non-inferiority margin of 10%, such that the endpoint is successfully met if the non-inferiority one-sided p-value is less than 0.025 or, equivalently, if the lower bound of a two-sided 95% confidence interval for the difference between PerClot and Arista hemostasis rates is greater than -10%.|Difference in percentage of participants|-1.4||||0.005|TWO_SIDED|95.0|-7.5|4.8|||Farrington-Manning score test||Directionality for difference in the percentage of participants achieving endpoint: PerClot - Arista|The primary efficacy hypothesis is that the percentage of participants achieving hemostasis of the treated bleeding site at 7 minutes in the overall PerClot group is non-inferior to the percentage of participants achieving hemostasis at 7 minutes in the Arista group, the active control.||4.8|-7.5|0.005
72579231|NCT02359994|144686787|NON_INFERIORITY|Non-inferiority was assessed with a pre-specified non-inferiority margin of 10%, such that the endpoint is successfully met if the non-inferiority one-sided p-value is less than 0.025 or, equivalently, if the lower bound of a two-sided 95% confidence interval for the difference between PerClot and Arista hemostasis rates is greater than -10%.|Difference in Percentage of Participants|4.8|||<|0.001|TWO_SIDED|95.0|-2.4|12.0|||Farrington-Manning score test||Directionality for difference in the percentage of participants achieving endpoint: PerClot - Arista|The secondary efficacy hypothesis is that the percentage of participants achieving hemostasis of the treated bleeding site at 5 minutes in the overall PerClot group is non-inferior to the percentage of participants achieving hemostasis at 5 minutes in the Arista group, the active control.||12.0|-2.4|<0.001
72579232|NCT04460885|144686821|NON_INFERIORITY|The response and change from baseline in response after 52 weeks are analysed using an analysis of covariance (ANCOVA) model with treatment and region as fixed factors, and baseline response as covariate.|Treatment difference|-0.19|||<|0.0001|TWO_SIDED|95.0|-0.36|-0.03|||ANCOVA|||||-0.03|-0.36|<0.0001
72579233|NCT03956355|144686884|SUPERIORITY||Risk Ratio (RR)|5.78|||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.0001
72579234|NCT03956355|144686885|SUPERIORITY||Risk Ratio (RR)|2.76|||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.0001
72579235|NCT03956355|144686886|SUPERIORITY||Risk Ratio (RR)|2.68||||0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.0001
72579236|NCT03956355|144686887|SUPERIORITY||Least squares mean difference|-3.28|||<|0.0001|TWO_SIDED||||||ANCOVA|||||||<0.0001
72579237|NCT03956355|144686888|SUPERIORITY||Risk Ratio (RR)|8.54||||0.0005|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.0005
72579238|NCT00733005|144687017|SUPERIORITY_OR_OTHER_LEGACY|||||||0.102||95.0|||||ANCOVA|||||||0.102
72579239|NCT00733005|144687018|SUPERIORITY_OR_OTHER_LEGACY|||||||0.019||95.0|||||ANCOVA|||||||0.019
72579240|NCT00266630|144687020|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.0|||||TWO_SIDED|95.0|-4.1|-1.9||||||||-1.90|-4.10|
72579241|NCT00266630|144687024|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.8|||||TWO_SIDED|95.0|-25.58|-14.06||||||||-14.06|-25.58|
72579242|NCT00886015|144687245|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.36|||||TWO_SIDED|95.0|0.96|1.93||||||||1.93|0.96|
72579243|NCT00886015|144687246|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.67|||||TWO_SIDED|95.0|0.46|0.98||||||||0.98|0.46|
72579244|NCT00886015|144687247|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.88|||||TWO_SIDED|95.0|0.66|1.18||||||||1.18|0.66|
72579245|NCT00886015|144687248|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.65|||||TWO_SIDED|95.0|0.44|0.98||||||||0.98|0.44|
72579246|NCT00886015|144687249|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.64|||||TWO_SIDED|95.0|0.42|0.97||||||Mild ECA compared with Normal||0.97|0.42|
72579247|NCT00886015|144687249|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.63|||||TWO_SIDED|95.0|0.39|1.01||||||Moderate ECA compared with Normal||1.01|0.39|
72579248|NCT00886015|144687249|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.62|||||TWO_SIDED|95.0|0.35|1.1||||||Severe ECA compared with Normal||1.10|0.35|
72579249|NCT00886015|144687250|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.22|||||TWO_SIDED|95.0|0.97|1.53||||||||1.53|0.97|
72579250|NCT02548156|144687269|SUPERIORITY_OR_OTHER||Ratio of LS mean|1.52|||<|0.0001|TWO_SIDED|95.0||||From ANCOVA of log transformed data: subject (random), treatment (fixed) and period (fixed) as factors, participant-level baseline and period-level baseline minus participant-level baseline as covariates.|ANCOVA||Treatment difference from ANCOVA of log transformed data. This therefore represents the ratio of the first named treatment to the second named treatment. A ratio \>1 favors the first named treatment.|Test and Reference dentifrice combined vs. Comparator dentifrice||||<0.0001
72579251|NCT01983566|144687273|NON_INFERIORITY_OR_EQUIVALENCE|The actual number of subjects analyzed is 16. No formal statistical hypothesis was tested.|Geometric mean ratio (%)|115.8||||0.3944|TWO_SIDED|90.0|63.52|211.11||The p-value relates to the null hypothesis of non-equivalence (bioequivalence test). P-value for ratio outside interval 80-125%.|ANOVA||This model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequence', 'period', and 'treatment'. The statistical analysis result is based on the adjusted means.|"The difference between the expected means for log(Dele low fat) and log(Dele fasted) was estimated by the differences in the adjusted means (Least Squares Means), and a 2 sided 90% confidence interval (CI) based on the t-distribution was computed.~These were then back transformed. The estimation model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequence', 'period', and 'treatment'."||211.11|63.52|0.3944
72579252|NCT01983566|144687274|NON_INFERIORITY_OR_EQUIVALENCE|The actual number of subjects analyzed is 16. No formal statistical hypothesis was tested.|Geometric mean ratio (%)|114.83||||0.3674|TWO_SIDED|90.0|74.803|176.281||The p-value relates to the null hypothesis of non-equivalence (bioequivalence test). P-value for ratio outside interval 80-125%.|ANOVA||This model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequence', 'period', and 'treatment'. The statistical analysis result is based on the adjusted means.|"The difference between the expected means for log(Dele low fat) and log(Dele fasted) was estimated by the differences in the adjusted means (Least Squares Means), and a 2 sided 90% CI based on the t-distribution was computed.~These were then back transformed. This estimation model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequence', 'period', and 'treatment'."||176.281|74.803|0.3674
72579253|NCT01068262|144687276|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|69.2|||||TWO_SIDED|90.0|50.9|80.2|||Linear mixed effect model|Back-transformed least squares estimates and confidence intervals from a linear mixed effect model were performed on natural log-transformed values.||||80.2|50.9|
72579254|NCT01068262|144687276|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1|||||TWO_SIDED|90.0|-14.7|14.9|||Linear mixed effects model|Back-transformed least squares estimates and confidence intervals from a linear mixed effect model were performed on natural log-transformed values.||||14.9|-14.7|
72579255|NCT01068262|144687277|SUPERIORITY_OR_OTHER||Estimate|0.9|||||TWO_SIDED|90.0|0.75|1.07||Hypothesis: Following 4 weeks of Qw oral dosing of Odanacatib 50 mg, there is no clinically important difference in the true GMR (male/postmenopausal female) of the AUC0-168hr. The GMR is contained within the interval (0.4, 2.0).|Geometric Mean Ratio (GMR); male/female|||||1.07|0.75|
72579256|NCT01068262|144687278|SUPERIORITY_OR_OTHER||GMR|0.93|||||TWO_SIDED|90.0|0.82|1.04|||GMR|||||1.04|0.82|
72579257|NCT01068262|144687279|SUPERIORITY_OR_OTHER||Estimate|0.95|||||TWO_SIDED|90.0|0.66|1.35|||GMR|||||1.35|0.66|
72579258|NCT01473407|144687308|NON_INFERIORITY_OR_EQUIVALENCE|An equivalence margin of +/- 0.5 was considered relevant to demonstrate the equivalence of the two products.|LS Mean Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.066|||TWO_SIDED|95.0|-0.25|0.01||||||Least Square (LS) mean and 95 percent confidence interval (CI) were derived from an ANCOVA model with fixed effect of treatment.||0.01|-0.25|
72579259|NCT01473407|144687309|NON_INFERIORITY_OR_EQUIVALENCE|An equivalence margin of +/- 0.5 was considered relevant to demonstrate the equivalence of the two products.|LS Mean Difference|0.37|STANDARD_ERROR_OF_MEAN|5.483|||TWO_SIDED|95.0|-10.4|11.13||||||LS mean and 95 percent CI were derived from an ANCOVA model with fixed effect of treatment.||11.13|-10.40|
72579260|NCT01473407|144687310|SUPERIORITY_OR_OTHER|||||||0.7563||||||P-value was calculated from a Wilcoxon Rank Sum test and t-approximation was used.|Wilcoxon Rank Sum test|||||||0.7563
72579261|NCT01473407|144687311|SUPERIORITY_OR_OTHER|||||||0.1061||||||P-value was calculated from a Wilcoxon Rank Sum test and t-approximation was used.|Wilcoxon Rank Sum test|||||||0.1061
72579262|NCT01473407|144687312|SUPERIORITY_OR_OTHER|||||||0.3369||||||P-value was calculated from a Wilcoxon Rank Sum test and t-approximation was used.|Wilcoxon Rank Sum test|||||||0.3369
72579263|NCT01027702|144687332|OTHER|||||||||||||||||"This was a dose-escalation study to determine a target DLI dose at which the:~1. Probability of CD4+ cells \> 100/µL by Day +120 is at least 66% and~2. Probability of grade II and III GVHD is at most 33%, probability of grade III GVHD is at most 17%, and no grade IV GVHD occurs Patients were assigned in cohorts of 3."|"The study design consisted of two phases, a dose-escalation phase and a dose-confirmation phase. In the dose-escalation phase, patients were assigned in cohorts of 3. The dose escalation plan was:~* If a grade IV acute GVHD event was observed at any dose, no more patients were assigned to this or higher dose levels unless the methotrexate dosing was modified.~* If none of the initial three patients at a dose level experienced grade II/III GVHD and \< 2/3 had a CD4+ count \> 100 at Day +120, the next three patients were assigned to the next higher dose level.~* If 1 out of 3 patients had grade III GVHD or 1 - 2 out of 3 patients had grade II GVHD and/or \> 2/3 have a CD4+ count \> 100 at Day +120, the dose was repeated for the next 3 patients.~The dose of 5 x 10\^4 CD3+ cells/kg was determined to be the optimal dose."|||
72579264|NCT01027702|144687333|OTHER|||||||||||||||||"This was a dose-escalation study to determine a target DLI dose at which the:~1. Probability of CD4+ cells \> 100/µL by Day +120 is at least 66% and~2. Probability of grade II and III GVHD is at most 33%, probability of grade III GVHD is at most 17%, and no grade IV GVHD occurs Patients were assigned in cohorts of 3."|"The study design consisted of two phases, a dose-escalation phase and a dose-confirmation phase. In the dose-escalation phase, patients were assigned in cohorts of 3. The dose escalation plan was:~If a grade IV acute GVHD event was observed at any dose, no more patients were assigned to this or higher dose levels unless the methotrexate dosing was modified.~If none of the initial three patients at a dose level experienced grade II/III GVHD and \< 2/3 had a CD4+ count \> 100 at Day +120, the next three patients were assigned to the next higher dose level.~If 1 out of 3 patients had grade III GVHD or 1 - 2 out of 3 patients had grade II GVHD and/or \> 2/3 have a CD4+ count \> 100 at Day +120, the dose was repeated for the next 3 patients.~The dose of 5 x 10\^4 CD3+ cells/kg was determined to be the optimal dose."|||
72579265|NCT01153425|144687344|OTHER|unpaired t-test for the difference of the means between the two arms|||||>|0.05|||||||t-test, 2 sided|||paired t-test for change from baseline to 24 months||||>0.05
72579266|NCT02932462|144687354|SUPERIORITY|||||||0.4557|||||||Cochran-Mantel-Haenszel|||||||0.4557
72579267|NCT02932462|144687355|SUPERIORITY|||||||0.8096|||||||Cochran-Mantel-Haenszel|||||||0.8096
72579268|NCT02932462|144687356|SUPERIORITY|||||||0.7652|||||||Cochran-Mantel-Haenszel|||||||0.7652
72579269|NCT02652949|144687357|SUPERIORITY||Event rate|0.023|||<|0.0001|ONE_SIDED|97.5||0.081|||Exact binomial test|||"The primary study endpoint, major device effect at 30 days, is a dichotomous study outcome; hence, an exact method based on the binomial distribution was used for the hypothesis testing. The primary study endpoint was tested against a performance goal of 16%:~H0: p ≥ 16% vs. Ha: p \<16%, where p denotes the true event rate of primary study endpoint in the target population."||0.081||<0.0001
72579270|NCT03022370|144687373|SUPERIORITY||Odds Ratio (OR)|0.92|||=|0.686|TWO_SIDED|95.0|0.62|1.37|||Regression, Logistic|||||1.37|0.62|=0.686
72579271|NCT03022370|144687373|SUPERIORITY||Odds Ratio (OR)|0.71|||=|0.032|TWO_SIDED|95.0|0.51|0.97|||Regression, Logistic|||||0.97|0.51|=0.032
72579272|NCT03022370|144687374|SUPERIORITY||Odds Ratio (OR)|0.9||||0.555|TWO_SIDED|95.0|0.64|1.28|||Regression, Logistic|||||1.28|0.64|0.555
72579273|NCT03022370|144687374|SUPERIORITY||Odds Ratio (OR)|0.74||||0.072|TWO_SIDED|95.0|0.54|1.03|||Regression, Logistic|||||1.03|0.54|0.072
72579274|NCT03022370|144687375|SUPERIORITY||Odds Ratio (OR)|0.93||||0.672|TWO_SIDED|95.0|0.66|1.31|||Regression, Logistic|||||1.31|0.66|0.672
72579275|NCT03022370|144687375|SUPERIORITY||Odds Ratio (OR)|0.7||||0.019|TWO_SIDED|95.0|0.52|0.94|||Regression, Logistic|||||0.94|0.52|0.019
72579276|NCT03022370|144687376|SUPERIORITY||Slope|-0.01||||0.984|TWO_SIDED|95.0|-0.88|0.86|||Regression, Linear|||||0.86|-0.88|0.984
72579277|NCT03022370|144687376|SUPERIORITY||Slope|0.06||||0.839|TWO_SIDED|95.0|-0.51|0.63|||Regression, Linear|||||0.63|-0.51|0.839
72579278|NCT03022370|144687377|SUPERIORITY||Slope|0.97|||<|0.0001|TWO_SIDED|95.0|0.43|1.51|||Tobit|Log + 1 performed on data||||1.51|0.43|<0.0001
72579279|NCT03022370|144687377|SUPERIORITY||Slope|0.21||||0.521|TWO_SIDED|95.0|-0.42|0.83|||Tobit|Log plus 1 to transform data||||0.83|-0.42|0.521
72579280|NCT03022370|144687378|SUPERIORITY||Slope|0.25||||0.718|TWO_SIDED|95.0|-1.09|1.58|||Regression, Linear|||||1.58|-1.09|0.718
72579281|NCT03022370|144687378|SUPERIORITY||Slope|-0.3||||0.712|TWO_SIDED|95.0|-1.87|1.28|||Regression, Linear|||||1.28|-1.87|0.712
72579282|NCT03022370|144687379|SUPERIORITY||Slope|-1.52||||0.067|TWO_SIDED|95.0|-3.14|0.11|||Regression, Linear|||||0.11|-3.14|0.067
72579283|NCT03022370|144687379|SUPERIORITY||Slope|-0.75||||0.398|TWO_SIDED|95.0|-2.48|0.99|||Regression, Linear|||||0.99|-2.48|0.398
72579284|NCT03022370|144687380|SUPERIORITY||Odds Ratio (OR)|1.29||||0.228|TWO_SIDED|95.0|0.85|1.97|||Regression, Logistic|||||1.97|0.85|0.228
72579285|NCT03022370|144687380|SUPERIORITY||Odds Ratio (OR)|0.86||||0.558|TWO_SIDED|95.0|0.53|1.41|||Regression, Logistic|||||1.41|0.53|0.558
72579286|NCT03022370|144687381|SUPERIORITY||Slope|0.14||||0.679|TWO_SIDED|95.0|-0.52|0.8|||Regression, Linear|||||0.80|-0.52|0.679
72579287|NCT03022370|144687381|SUPERIORITY||Slope|0.55||||0.08|TWO_SIDED|95.0|-0.07|1.16|||Regression, Linear|||||1.16|-0.07|0.08
72579288|NCT03022370|144687382|SUPERIORITY||Slope|-0.13||||0.81|TWO_SIDED|95.0|-1.21|0.95|||Regression, Linear|||||0.95|-1.21|0.810
72579289|NCT03022370|144687382|SUPERIORITY||Slope|-1.03||||0.041|TWO_SIDED|95.0|-2.01|-0.04|||Regression, Linear|||||-0.04|-2.01|0.041
72579290|NCT03022370|144687383|SUPERIORITY||Odds Ratio (OR)|1.14||||0.635|TWO_SIDED|95.0|0.67|1.92|||Regression, Logistic|||||1.92|0.67|0.635
72579291|NCT03022370|144687383|SUPERIORITY||Odds Ratio (OR)|0.72||||0.256|TWO_SIDED|95.0|0.41|1.27|||Regression, Logistic|||||1.27|0.41|0.256
72579292|NCT03022370|144687384|SUPERIORITY||Odds Ratio (OR)|1.16||||0.526|TWO_SIDED|95.0|0.73|1.84|||Regression, Logistic|||||1.84|0.73|0.526
72579293|NCT03022370|144687384|SUPERIORITY||Odds Ratio (OR)|1.02||||0.931|TWO_SIDED|95.0|0.67|1.56|||Regression, Logistic|||||1.56|0.67|0.931
72579294|NCT03022370|144687385|SUPERIORITY||Odds Ratio (OR)|0.92||||0.691|TWO_SIDED|95.0|0.63|1.36|||Regression, Logistic|||||1.36|0.63|0.691
72579295|NCT03022370|144687385|SUPERIORITY||Odds Ratio (OR)|0.92||||0.692|TWO_SIDED|95.0|0.6|1.4|||Regression, Logistic|||||1.40|0.60|0.692
72579296|NCT03022370|144687386|SUPERIORITY||Slope|-0.31||||0.137|TWO_SIDED|95.0|-0.72|0.24|||Regression, Linear|||||0.24|-0.72|0.137
72579297|NCT03022370|144687386|SUPERIORITY||Slope|-0.09||||0.721|TWO_SIDED|95.0|-0.58|0.4|||Regression, Linear|||||0.40|-0.58|0.721
72579298|NCT03022370|144687387|SUPERIORITY||Slope|-0.23||||0.332|TWO_SIDED|95.0|-0.7|0.24|||Regression, Linear|||||0.24|-0.70|0.332
72579299|NCT03022370|144687387|SUPERIORITY||Slope|-0.19||||0.468|TWO_SIDED|95.0|-0.71|0.32|||Regression, Linear|||||0.32|-0.71|0.468
72579300|NCT03022370|144687388|SUPERIORITY||Odds Ratio (OR)|1.3||||0.174|TWO_SIDED|95.0|0.89|1.9|||Regression, Logistic|||||1.90|0.89|0.174
72579301|NCT03022370|144687388|SUPERIORITY||Odds Ratio (OR)|1.49||||0.129|TWO_SIDED|95.0|0.89|2.5|||Regression, Logistic|||||2.50|0.89|0.129
72579302|NCT03022370|144687389|SUPERIORITY||Odds Ratio (OR)|1.3||||0.174|TWO_SIDED|95.0|0.89|1.9|||Regression, Logistic|||||1.90|0.89|0.174
72411416|NCT03207750|144331228|NON_INFERIORITY|Lower limit (LL) of the two-sided asymptotic standardized 95% CI for the difference in seroprotective concentration (HRV PCV-free Liquid group minus HRV Lyophilized group) for each of anti-HB antibodies should be ≥-10%.|Difference in anti-HB concentration|-0.65|||||TWO_SIDED|95.0|-1.9|0.16||||||Non-inferiority of the immune responses to 3 doses of Pediarix, Hiberix and Prevenar 13 when co-administered with 2 doses of the PCV-free liquid HRV vaccine, as compared to when co-administered with lyophilized HRV vaccine in terms of group difference in percentage of subjects with seroprotective concentrations (≥ 10 mIU/mL) of anti-HB antibodies.||0.16|-1.90|
72579303|NCT03022370|144687389|SUPERIORITY||Odds Ratio (OR)|0.96||||0.836|TWO_SIDED|95.0|0.64|1.43|||Regression, Logistic|||||1.43|0.64|0.836
72579304|NCT01311687|144687390|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.45|||<|0.001|TWO_SIDED|95.0|0.35|0.59|||Stratified Log Rank Test|Stratified by age, disease population, and prior number of anti myeloma therapy.|Hazard ratio is for Pomalidomide Plus Low-Dose Dexamethasone : High Dose Dexamethasone|||0.59|0.35|<0.001
72579305|NCT01311687|144687391|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.49|||<|0.001|TWO_SIDED|95.0|0.39|0.61|||Stratified log-rank test|Stratified by age, disease population, and prior number of anti myeloma therapy.|Hazard ratio is for Pomalidomide Plus Low-Dose Dexamethasone : High Dose Dexamethasone|||0.61|0.39|<0.001
72579306|NCT01311687|144687393|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.53|||<|0.001|TWO_SIDED|95.0|0.37|0.74|||Log Rank||Hazard ratio is for Pomalidomide Plus Low-Dose Dexamethasone : High Dose Dexamethasone|||0.74|0.37|<0.001
72579307|NCT01311687|144687394|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.7||||0.009|TWO_SIDED|95.0|0.54|0.92|||Log Rank||Hazard ratio is for Pomalidomide Plus Low-Dose Dexamethasone : High Dose Dexamethasone|||0.92|0.54|0.009
72579308|NCT01311687|144687395|SUPERIORITY||Hazard Ratio (HR)|0.74||||0.005|TWO_SIDED|95.0|0.6|0.91|||Log Rank||Hazard ratio is for Pomalidomide Plus Low-Dose Dexamethasone : High Dose Dexamethasone|||0.91|0.60|0.005
72579309|NCT01311687|144687396|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|7.53|||<|0.001|TWO_SIDED|95.0|3.19|17.77|||Fisher Exact||Odds ratio is for pomalidomide plus low-dose dexamethasone : high dose dexamethasone|||17.77|3.19|< 0.001
72411417|NCT03207750|144331229|NON_INFERIORITY|Lower limit (LL) of the two-sided asymptotic standardized 95% CI for the difference in seroprotective concentration (HRV PCV-free Liquid group minus HRV Lyophilized group) for each of anti-poliovirus type 1 antibodies should be ≥-5%.|Difference in anti-polio 1 concentration|0.21|||||TWO_SIDED|95.0|-0.6|1.15||||||Non-inferiority of the immune responses to 3 doses of Pediarix, Hiberix and Prevenar 13 when co-administered with 2 doses of the PCV-free liquid HRV vaccine, as compared to when co-administered with lyophilized HRV vaccine in terms of group difference in percentage of subjects with seroprotective titers (≥ 8 ED50) of anti-poliovirus type 1 antibodies.||1.15|-0.60|
72544775|NCT01488019|144618710|NON_INFERIORITY|The hazard ratio and 90% two-sided confidence interval for the hazard ratio comparing Perforomist to placebo were estimated. Non-inferiority was declared if the upper limit of the two-sided 90% confidence interval was wholly less than 1.5.|Hazard Ratio (HR)|0.965|||||TWO_SIDED|90.0|0.711|1.308||Hazard Ratio was calculated as Perforomist vs Placebo. The non-inferiority margin for the hazard ratio is 1.5. Subjects with no primary event at withdrawal or study completion were treated as censored observations at time of withdrawal|Regression, Cox|Treatment, site group, and bronchodilator reversibility included as covariates in the model.|Hazard Ratio was calculated as Perforomist Inhalation Solution vs Placebo. The non-inferiority margin for the hazard ratio is 1.5.|||1.308|0.711|
72411418|NCT03207750|144331229|NON_INFERIORITY|Lower limit (LL) of the two-sided asymptotic standardized 95% CI for the difference in seroprotective concentration (HRV PCV-free Liquid group minus HRV Lyophilized group) for each of anti-poliovirus type 2 antibodies should be ≥-5%.|Difference in anti-polio 2 concentration|-0.01|||||TWO_SIDED|95.0|-1.02|0.98||||||Non-inferiority of the immune responses to 3 doses of Pediarix, Hiberix and Prevenar 13 when co-administered with 2 doses of the PCV-free liquid HRV vaccine, as compared to when co-administered with lyophilized HRV vaccine in terms of group difference in percentage of subjects with seroprotective titers (≥ 8 ED50) of anti-poliovirus type 2 antibodies.||0.98|-1.02|
72544776|NCT02400710|144618724|SUPERIORITY_OR_OTHER|||||||0.05|TWO_SIDED||||||ANOVA|||||||.05
72544777|NCT02400710|144618725|SUPERIORITY_OR_OTHER|||||||0.05|TWO_SIDED||||||Chi-squared|||||||.05
72544778|NCT04147715|144618736|OTHER|The drug interaction was assessed by whether the 90% CIs for the geometric least squares mean ratio of Cmax, Cτ, and AUC0-τ of S-648414 were completely contained within the range of 0.8000 to 1.2500.|Geometric Least Squares Mean Ratio|0.9913|||||TWO_SIDED|90.0|0.9232|1.0645|||||Ratio = S-648414 + Dolutegravir / S-648414|The effect of dolutegravir on the PK of S-648414 was assessed by analysis of variance (ANOVA) fit with a linear mixed effect model with the natural log (ln)-transformed Cmax as the dependent variable, treatment as fixed effect, and participant as random effect. The difference and 90% confidence interval (CI) between the ln-transformed Cmax of S-648414 + dolutegravir and S-648414 alone were estimated then back-transformed to obtain the corresponding geometric least squares mean ratio and 90% CI.||1.0645|0.9232|
72544779|NCT04147715|144618736|OTHER|The drug interaction was assessed by whether the 90% CIs for the geometric least squares mean ratio of Cmax, Cτ, and AUC0-τ of S-648414 were completely contained within the range of 0.8000 to 1.2500.|Geometric Least Squares Mean Ratio|0.9754|||||TWO_SIDED|90.0|0.8916|1.0671|||||Ratio = S-648414 + Dolutegravir / S-648414|The effect of dolutegravir on the PK of S-648414 was assessed by an ANOVA fitted with a linear mixed effect model with the natural log-transformed Cmax as the dependent variable, treatment as fixed effect, and participant as random effect. The difference and 90% CI between the ln-transformed Cmax of S-648414 + dolutegravir and S-648414 alone were estimated then back-transformed to obtain the corresponding geometric least squares mean ratio and 90% CI.||1.0671|0.8916|
72544780|NCT04147715|144618738|OTHER|The drug interaction was assessed by whether the 90% CIs for the geometric least squares mean ratio of Cmax, Cτ, and AUC0-τ of S-648414 were completely contained within the range of 0.8000 to 1.2500.|Geometric Least Squares Mean Ratio|1.0353|||||TWO_SIDED|90.0|0.9421|1.1377|||||Ratio = S-648414 + Dolutegravir / S-648414|The effect of dolutegravir on the PK of S-648414 was assessed using an ANOVA fitted with a linear mixed effect model with the natural log-transformed Cτ as the dependent variable, treatment as a fixed effect, and participant as a random effect. The difference and 90% CI between the ln-transformed Cτ of S-648414 + dolutegravir and S-648414 alone were estimated then back-transformed to obtain the corresponding geometric least squares mean ratio and 90% CI.||1.1377|0.9421|
72544781|NCT04147715|144618738|OTHER|The drug interaction was assessed by whether the 90% CIs for the geometric least squares mean ratio of Cmax, Cτ, and AUC0-τ of S-648414 were completely contained within the range of 0.8000 to 1.2500.|Geometric Least Squares Mean Ratio|0.9096|||||TWO_SIDED|90.0|0.8791|0.9411|||||Ratio = S-648414 + Dolutegravir / S-648414|The effect of dolutegravir on the PK of S-648414 was assessed using an ANOVA fitted with a linear mixed effect model with the natural log-transformed Cτ as the dependent variable, treatment as a fixed effect, and participant as a random effect. The difference and 90% CI between the ln-transformed Cτ of S-648414 + dolutegravir and S-648414 alone were estimated then back-transformed to obtain the corresponding geometric least squares mean ratio and 90% CI.||0.9411|0.8791|
72544782|NCT04147715|144618739|OTHER|The drug interaction was assessed by whether the 90% CIs for the geometric least squares mean ratio of Cmax, Cτ, and AUC0-τ of S-648414 were completely contained within the range of 0.8000 to 1.2500.|Geometric Least Squares Mean Ratio|1.0071|||||TWO_SIDED|90.0|0.9679|1.0479|||||Ratio = S-648414 + Dolutegravir / S-648414|The effect of dolutegravir on the PK of S-648414 was assessed using an ANOVA fitted with a linear mixed effect model with the natural log-transformed AUC0-τ as the dependent variable, treatment as a fixed effect, and participant as a random effect. The difference and 90% CI between the ln-transformed AUC0-τ of S-648414 + dolutegravir and S-648414 alone were estimated then back-transformed to obtain the corresponding geometric least squares mean ratio and 90% CI.||1.0479|0.9679|
72579310|NCT01311687|144687397|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|8.44|||<|0.001|TWO_SIDED|95.0|3.32|21.42|||Fisher Exact||Odds ratio is for Pomalidomide Plus Low-Dose Dexamethasone : High Dose Dexamethasone|||21.42|3.32|< 0.001
72579311|NCT01311687|144687398|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.46|||<|0.001|TWO_SIDED|95.0|0.36|0.59|||Stratified Log Rank Test|Stratified by age, diseases population, and prior number of anti myeloma therapy.|Hazard ratio is for Pomalidomide Plus Low-Dose Dexamethasone : High Dose Dexamethasone|||0.59|0.36|< 0.001
72411419|NCT03207750|144331229|NON_INFERIORITY|Lower limit (LL) of the two-sided asymptotic standardized 95% CI for the difference in seroprotective concentration (HRV PCV-free Liquid group minus HRV Lyophilized group) for each of anti-poliovirus type 3 antibodies should be ≥-5%.|Difference in anti-polio 3 concentration|0.0|||||TWO_SIDED|95.0|-0.87|0.84||||||Non-inferiority of the immune responses to 3 doses of Pediarix, Hiberix and Prevenar 13 when co-administered with 2 doses of the PCV-free liquid HRV vaccine, as compared to when co-administered with lyophilized HRV vaccine in terms of group difference in percentage of subjects with seroprotective titers (≥ 8 ED50) of anti-poliovirus type 3 antibodies.||0.84|-0.87|
72411420|NCT03207750|144331230|NON_INFERIORITY|Lower limit (LL) of the two-sided 95% CI on GMC ratios (HRV PCV-free Liquid group over HRV Lyophilized group) for each of anti-PT antibodies should be ≥ 0.67.|GMC ratio|0.94|||||TWO_SIDED|95.0|0.86|1.03|||ANOVA|ANOVA model that included the vaccine group as fixed effect.||Non-inferiority of the immune responses to 3 doses of Pediarix, Hiberix and Prevenar 13 when co-administered with 2 doses of the PCV-free liquid HRV vaccine, as compared to when co-administered with lyophilized HRV vaccine in terms of GMC ratios for anti-PT antibodies.||1.03|0.86|
72411421|NCT03207750|144331230|NON_INFERIORITY|Lower limit (LL) of the two-sided 95% CI on GMC ratios (HRV PCV-free Liquid group over HRV Lyophilized group) for each of anti-FHA antibodies should be ≥ 0.67.|GMC ratio|1.0|||||TWO_SIDED|95.0|0.92|1.08|||ANOVA|ANOVA model that included the vaccine group as fixed effect.||Non-inferiority of the immune responses to 3 doses of Pediarix, Hiberix and Prevenar 13 when co-administered with 2 doses of the PCV-free liquid HRV vaccine, as compared to when co-administered with lyophilized HRV vaccine in terms of GMC ratios for anti-FHA antibodies.||1.08|0.92|
72411422|NCT03207750|144331230|NON_INFERIORITY|Lower limit (LL) of the two-sided 95% CI on GMC ratios (HRV PCV-free Liquid group over HRV Lyophilized group) for each of anti-PRN antibodies should be ≥ 0.67.|GMC ratio|0.97|||||TWO_SIDED|95.0|0.86|1.1|||ANOVA|ANOVA model that included the vaccine group as fixed effect.||Non-inferiority of the immune responses to 3 doses of Pediarix, Hiberix and Prevenar 13 when co-administered with 2 doses of the PCV-free liquid HRV vaccine, as compared to when co-administered with lyophilized HRV vaccine in terms of GMC ratios for anti-PRN antibodies.||1.10|0.86|
72411423|NCT03207750|144331231|NON_INFERIORITY|Lower limit (LL) of the two-sided 95% CI on GMC ratios (HRV PCV-free Liquid group over HRV Lyophilized group) for S. pneumoniae serotype 1 should be ≥ 0.5.|GMC ratio|1.03|||||TWO_SIDED|95.0|0.93|1.14|||ANOVA|ANOVA model that included the vaccine group as fixed effect.||Non-inferiority of the immune responses to 3 doses of Pediarix, Hiberix and Prevenar 13 when co-administered with 2 doses of the PCV-free liquid HRV vaccine, as compared to when co-administered with lyophilized HRV vaccine in terms of GMC ratios for Streptococcus pneumoniae (S. pneumoniae) serotype 1.||1.14|0.93|
72411424|NCT03207750|144331231|NON_INFERIORITY|Lower limit (LL) of the two-sided 95% CI on GMC ratios (HRV PCV-free Liquid group over HRV Lyophilized group) for S. pneumoniae serotype 3 should be ≥ 0.5.|GMC ratio|1.0|||||TWO_SIDED|95.0|0.91|1.11|||ANOVA|ANOVA model that included the vaccine group as fixed effect.||Non-inferiority of the immune responses to 3 doses of Pediarix, Hiberix and Prevenar 13 when co-administered with 2 doses of the PCV-free liquid HRV vaccine, as compared to when co-administered with lyophilized HRV vaccine in terms of GMC ratios for Streptococcus pneumoniae (S. pneumoniae) serotype 3.||1.11|0.91|
72411425|NCT03207750|144331231|NON_INFERIORITY|Lower limit (LL) of the two-sided 95% CI on GMC ratios (HRV PCV-free Liquid group over HRV Lyophilized group) for S. pneumoniae serotype 4 should be ≥ 0.5.|GMC ratio|0.99|||||TWO_SIDED|95.0|0.9|1.09|||ANOVA|ANOVA model that included the vaccine group as fixed effect.||Non-inferiority of the immune responses to 3 doses of Pediarix, Hiberix and Prevenar 13 when co-administered with 2 doses of the PCV-free liquid HRV vaccine, as compared to when co-administered with lyophilized HRV vaccine in terms of GMC ratios for Streptococcus pneumoniae (S. pneumoniae) serotype 4.||1.09|0.90|
72411426|NCT03207750|144331231|NON_INFERIORITY|Lower limit (LL) of the two-sided 95% CI on GMC ratios (HRV PCV-free Liquid group over HRV Lyophilized group) for S. pneumoniae serotype 5 should be ≥ 0.5.|GMC ratio|1.05|||||TWO_SIDED|95.0|0.94|1.17|||ANOVA|ANOVA model that included the vaccine group as fixed effect.||Non-inferiority of the immune responses to 3 doses of Pediarix, Hiberix and Prevenar 13 when co-administered with 2 doses of the PCV-free liquid HRV vaccine, as compared to when co-administered with lyophilized HRV vaccine in terms of GMC ratios for Streptococcus pneumoniae (S. pneumoniae) serotype 5.||1.17|0.94|
72411427|NCT03207750|144331231|NON_INFERIORITY|Lower limit (LL) of the two-sided 95% CI on GMC ratios (HRV PCV-free Liquid group over HRV Lyophilized group) for S. pneumoniae serotype 6A should be ≥ 0.5.|GMC ratio|1.01|||||TWO_SIDED|95.0|0.92|1.12|||ANOVA|ANOVA model that included the vaccine group as fixed effect.||Non-inferiority of the immune responses to 3 doses of Pediarix, Hiberix and Prevenar 13 when co-administered with 2 doses of the PCV-free liquid HRV vaccine, as compared to when co-administered with lyophilized HRV vaccine in terms of GMC ratios for Streptococcus pneumoniae (S. pneumoniae) serotype 6A.||1.12|0.92|
72411428|NCT03207750|144331231|NON_INFERIORITY|Lower limit (LL) of the two-sided 95% CI on GMC ratios (HRV PCV-free Liquid group over HRV Lyophilized group) for S. pneumoniae serotype 6B should be ≥ 0.5.|GMC ratio|0.96|||||TWO_SIDED|95.0|0.83|1.12|||ANOVA|ANOVA model that included the vaccine group as fixed effect.||Non-inferiority of the immune responses to 3 doses of Pediarix, Hiberix and Prevenar 13 when co-administered with 2 doses of the PCV-free liquid HRV vaccine, as compared to when co-administered with lyophilized HRV vaccine in terms of GMC ratios for Streptococcus pneumoniae (S. pneumoniae) serotype 6B.||1.12|0.83|
72579312|NCT01965860|144687479|SUPERIORITY|||||||0.001|||||||ANOVA|||"Prior to the study a power analysis was performed to calculate the number of participants required in each of the three groups. Previous work comparing OSATS derived scores in endovascular interventions shows a Cohen D of two. Using a of .05, a power of .80, and an expected dropout rate of 10%, the minimum number of surgical trainees required per group was seven.~Null hypothesis for primary outcome: no difference in technical performance during real life procedures between the three groups"||||0.001
72579313|NCT01965860|144687479|OTHER|||||||0.003|||||||ANOVA|||Null Hypothesis: There is no difference in Pre and Post test MCQ score||||0.003
72579314|NCT01965860|144687479|OTHER|||||||0.001|||||||ANOVA|||Null Hypothesis: There is no difference in Pre and Post test MCQ score||||0.001
72579315|NCT01965860|144687479|OTHER|||||||0.228|||||||ANOVA|||Null Hypothesis: There is no difference in Pre and Post test MCQ score||||0.228
72544783|NCT04147715|144618739|OTHER|The drug interaction was assessed by whether the 90% CIs for the geometric least squares mean ratio of Cmax, Cτ, and AUC0-τ of S-648414 were completely contained within the range of 0.8000 to 1.2500.|Geometric Least Squares Mean Ratio|0.9852|||||TWO_SIDED|90.0|0.9605|1.0105|||||Ratio = S-648414 + Dolutegravir / S-648414|The effect of dolutegravir on the PK of S-648414 was assessed using an ANOVA fitted with a linear mixed effect model with the natural log-transformed AUC0-τ as the dependent variable, treatment as a fixed effect, and participant as a random effect. The difference and 90% CI between the ln-transformed AUC0-τ of S-648414 + dolutegravir and S-648414 alone were estimated then back-transformed to obtain the corresponding geometric least squares mean ratio and 90% CI.||1.0105|0.9605|
72544784|NCT04147715|144618741|OTHER|The drug interaction was assessed by whether the 90% CIs for the geometric least squares mean ratio of Cmax, Cτ, and AUC0-τ of dolutegravir were completely contained within the range of 0.8000 to 1.2500.|Geometric Least Squares Mean Ratio|1.1806|||||TWO_SIDED|90.0|1.1171|1.2477|||||Ratio = S-648414 + Dolutegravir / Dolutegravir|The effect of S-648414 on the plasma PK of dolutegravir was assessed using an ANOVA fitted with a linear mixed effect model with the natural log-transformed Cmax as the dependent variable, treatment as a fixed effect, and participant as a random effect. The difference and 90% CI between the ln-transformed Cmax of dolutegravir plus S-648414 and dolutegravir alone was estimated then back-transformed to obtain the corresponding geometric least squares mean ratio and 90% CI.||1.2477|1.1171|
72544785|NCT04147715|144618741|OTHER|The drug interaction was assessed by whether the 90% CIs for the geometric least squares mean ratio of Cmax, Cτ, and AUC0-τ of dolutegravir were completely contained within the range of 0.8000 to 1.2500.|Geometric Least Squares Mean Ratio|1.048|||||TWO_SIDED|90.0|0.9656|1.1373|||||Ratio = S-648414 + Dolutegravir / Dolutegravir|The effect of S-648414 on the plasma PK of dolutegravir was assessed using an ANOVA fitted with a linear mixed effect model with the natural log-transformed Cmax as the dependent variable, treatment as a fixed effect, and participant as a random effect. The difference and 90% CI between the ln-transformed Cmax of dolutegravir plus S-648414 and dolutegravir alone was estimated then back-transformed to obtain the corresponding geometric least squares mean ratio and 90% CI.||1.1373|0.9656|
72544786|NCT04147715|144618743|OTHER|The drug interaction was assessed by whether the 90% CIs for the geometric least squares mean ratio of Cmax, Cτ, and AUC0-τ of dolutegravir were completely contained within the range of 0.8000 to 1.2500.|Geometric Least Squares Mean Ratio|1.3445|||||TWO_SIDED|90.0|1.2352|1.4636|||||Ratio = S-648414 + Dolutegravir / Dolutegravir|The effect of S-648414 on the plasma PK of dolutegravir was assessed using an ANOVA fitted with a linear mixed effect model with the natural log-transformed Cτ as the dependent variable, treatment as a fixed effect, and participant as a random effect. The difference and 90% CI between the ln-transformed Cτ of dolutegravir plus S-648414 and dolutegravir alone was estimated then back-transformed to obtain the corresponding geometric least squares mean ratio and 90% CI.||1.4636|1.2352|
72544787|NCT04147715|144618743|OTHER|The drug interaction was assessed by whether the 90% CIs for the geometric least squares mean ratio of Cmax, Cτ, and AUC0-τ of dolutegravir were completely contained within the range of 0.8000 to 1.2500.|Geometric Least Squares Mean Ratio|1.0769|||||TWO_SIDED|90.0|1.0137|1.1441|||||Ratio = S-648414 + Dolutegravir / Dolutegravir|The effect of S-648414 on the plasma PK of dolutegravir was assessed using an ANOVA fitted with a linear mixed effect model with the natural log-transformed Cτ as the dependent variable, treatment as a fixed effect, and participant as a random effect. The difference and 90% CI between the ln-transformed Cτ of dolutegravir plus S-648414 and dolutegravir alone was estimated then back-transformed to obtain the corresponding geometric least squares mean ratio and 90% CI.||1.1441|1.0137|
72544788|NCT04147715|144618744|OTHER|The drug interaction was assessed by whether the 90% CIs for the geometric least squares mean ratio of Cmax, Cτ, and AUC0-τ of dolutegravir were completely contained within the range of 0.8000 to 1.2500.|Geometric Least Squares Mean Ratio|1.1939|||||TWO_SIDED|90.0|1.1176|1.2754|||||Ratio = S-648414 + Dolutegravir / Dolutegravir|The effect of S-648414 on the plasma PK of dolutegravir was assessed using an ANOVA fitted with a linear mixed effect model with the natural log-transformed AUC0-τ as the dependent variable, treatment as a fixed effect, and participant as a random effect. The difference and 90% CI between the ln-transformed AUC0-τ of dolutegravir plus S-648414 and dolutegravir alone was estimated then back-transformed to obtain the corresponding geometric least squares mean ratio and 90% CI.||1.2754|1.1176|
72544789|NCT04147715|144618744|OTHER|The drug interaction was assessed by whether the 90% CIs for the geometric least squares mean ratio of Cmax, Cτ, and AUC0-τ of dolutegravir were completely contained within the range of 0.8000 to 1.2500.|Geometric Least Squares Mean Ratio|1.0482|||||TWO_SIDED|90.0|0.9881|1.1119|||||Ratio = S-648414 + Dolutegravir / Dolutegravir|The effect of S-648414 on the plasma PK of dolutegravir was assessed using an ANOVA fitted with a linear mixed effect model with the natural log-transformed AUC0-τ as the dependent variable, treatment as a fixed effect, and participant as a random effect. The difference and 90% CI between the ln-transformed AUC0-τ of dolutegravir plus S-648414 and dolutegravir alone was estimated then back-transformed to obtain the corresponding geometric least squares mean ratio and 90% CI.||1.1119|0.9881|
72544790|NCT04147715|144618746|OTHER||Slope|0.9857|||||TWO_SIDED|95.0|0.9341|1.0373||||||The dose proportionality of plasma PK parameters of S-648414 was examined for all fasted groups in Part 1 using the power model. The power model assumes a linear relationship between the ln-transformed parameter and ln-transformed dose where ln(Cmax) = Intercept + Slope × ln(Dose) + Random error||1.0373|0.9341|
72579316|NCT01965860|144687479|OTHER|||||||0.001|||||||ANOVA|||Null Hypothesis: There is no difference in Pre and Post test GRS score||||0.001
72579317|NCT01965860|144687479|OTHER|||||||0.008|||||||ANOVA|||Null Hypothesis: There is no difference in Pre and Post test GRS score||||0.008
72579318|NCT01965860|144687479|OTHER|||||||0.164|||||||ANOVA|||Null Hypothesis: There is no difference in Pre and Post test GRS score||||0.164
72579319|NCT01965860|144687479|OTHER|||||||0.001|||||||ANOVA|||Null Hypothesis: There is no difference in Pre and Post test Examiner's checklist score||||0.001
72579320|NCT01965860|144687479|OTHER|||||||0.001|||||||ANOVA|||Null Hypothesis: There is no difference in Pre and Post test Examiner's checklist score||||0.001
72579321|NCT01965860|144687479|OTHER|||||||0.19|||||||ANOVA|||Null Hypothesis: There is no difference in Pre and Post test Examiner's checklist score||||0.190
72579322|NCT02288325|144687484|SUPERIORITY||Hazard Ratio (HR)|0.56||||0.0212|TWO_SIDED|95.0|0.33|0.92|||Log Rank|||||0.92|0.33|0.0212
72579323|NCT03656744|144687509|SUPERIORITY|||||||0.199|||||||ANCOVA|||||||0.199
72579324|NCT03656744|144687509|SUPERIORITY|||||||0.011|||||||ANCOVA|||||||0.011
72579325|NCT03656744|144687510|SUPERIORITY|||||||0.152|||||||ANCOVA|||||||0.152
72544791|NCT04147715|144618746|OTHER||Geometric Least Squares Mean Ratio|0.8786|||||TWO_SIDED|90.0|0.7705|1.0019|||||Ratio = Fed / Fasted|"The effect of food on the plasma PK of S-648414 was examined after a single dose of 100 mg S-648414 in the fed state and fasted state using an ANOVA fitted with a linear mixed effect model with ln-transformed Cmax as the dependent variable, treatment as a fixed effect, and participant as random effect.~The difference and 90% CI between the fed and fasted state ln-transformed Cmax were estimated, then back-transformed to obtain the corresponding geometric least squares mean ratio and 90% CI."||1.0019|0.7705|
72544792|NCT04147715|144618748|OTHER||Slope|1.0252|||||TWO_SIDED|95.0|0.984|1.0665||||||The dose proportionality of plasma PK parameters of S-648414 was examined for all fasted groups in Part 1 using the power model. The power model assumes a linear relationship between the ln-transformed parameter and ln-transformed dose where ln(AUC0-last) = Intercept + Slope × ln(Dose) + Random error||1.0665|0.9840|
72579326|NCT03656744|144687510|SUPERIORITY|||||||0.109|||||||ANCOVA|||||||0.109
72411429|NCT03207750|144331231|NON_INFERIORITY|Lower limit (LL) of the two-sided 95% CI on GMC ratios (HRV PCV-free Liquid group over HRV Lyophilized group) for S. pneumoniae serotype 7F should be ≥ 0.5.|GMC ratio|0.99|||||TWO_SIDED|95.0|0.91|1.08|||ANOVA|ANOVA model that included the vaccine group as fixed effect.||Non-inferiority of the immune responses to 3 doses of Pediarix, Hiberix and Prevenar 13 when co-administered with 2 doses of the PCV-free liquid HRV vaccine, as compared to when co-administered with lyophilized HRV vaccine in terms of GMC ratios for Streptococcus pneumoniae (S. pneumoniae) serotype 7F.||1.08|0.91|
72579327|NCT03656744|144687511|SUPERIORITY|||||||0.034|||||||ANCOVA|||||||0.034
72579328|NCT03656744|144687511|SUPERIORITY|||||||0.004|||||||ANCOVA|||||||0.004
72579329|NCT03656744|144687512|SUPERIORITY|||||||0.884|||||||Regression, Logistic|||||||0.884
72579330|NCT03656744|144687512|SUPERIORITY|||||||0.236|||||||Regression, Logistic|||||||0.236
72579331|NCT03656744|144687513|SUPERIORITY|||||||0.196|||||||ANCOVA|||||||0.196
72579332|NCT03656744|144687513|SUPERIORITY|||||||0.016|||||||ANCOVA|||||||0.016
72579333|NCT03656744|144687514|SUPERIORITY|||||||0.294|||||||Cochran-Mantel-Haenszel|||||||0.294
72579334|NCT03656744|144687515|SUPERIORITY|||||||0.287|||||||Regression, Logistic|||||||0.287
72579335|NCT03656744|144687515|SUPERIORITY|||||||0.09|||||||Regression, Logistic|||||||0.090
72579336|NCT03656744|144687516|SUPERIORITY|||||||0.201|||||||ANCOVA|||||||0.201
72329492|NCT01498692|144184399|SUPERIORITY_OR_OTHER||Percent Target Lesion Failure|2.4|||<|0.0001|ONE_SIDED|95.0||7.3|||One-group exact binomial test|||A one-group exact binomial test was used to test the hypothesis that the primary endpoint rate in the PROMUS Element cohort is less than the predefined performance goal of 21.1%.||7.3||<0.0001
72579337|NCT03656744|144687516|SUPERIORITY|||||||0.534|||||||ANCOVA|||||||0.534
72579338|NCT03656744|144687517|SUPERIORITY|||||||0.955|||||||ANCOVA|||||||0.955
72579339|NCT03656744|144687517|SUPERIORITY|||||||0.072|||||||ANCOVA|||||||0.072
72579340|NCT03656744|144687518|SUPERIORITY|||||||0.041|||||||ANCOVA|||||||0.041
72579341|NCT03656744|144687518|SUPERIORITY|||||||0.12|||||||ANCOVA|||||||0.120
72579342|NCT03656744|144687519|SUPERIORITY|||||||0.955|||||||ANCOVA|||||||0.955
72579343|NCT03656744|144687519|SUPERIORITY|||||||0.072|||||||ANCOVA|||||||0.072
72579344|NCT03656744|144687520|SUPERIORITY|||||||0.488|||||||ANCOVA|||||||0.488
72579345|NCT03656744|144687520|SUPERIORITY|||||||0.022|||||||ANCOVA|||||||0.022
72579346|NCT03656744|144687521|SUPERIORITY|||||||0.674|||||||ANCOVA|||||||0.674
72579347|NCT03656744|144687521|SUPERIORITY|||||||0.03|||||||ANCOVA|||||||0.030
72579348|NCT03656744|144687522|SUPERIORITY|||||||0.588|||||||Regression, Logistic|||||||0.588
72579349|NCT03656744|144687522|SUPERIORITY|||||||0.103|||||||Regression, Logistic|||||||0.103
72579350|NCT03656744|144687523|SUPERIORITY|||||||0.236|||||||ANCOVA|||||||0.236
72579351|NCT03656744|144687523|SUPERIORITY|||||||0.944|||||||ANCOVA|||||||0.944
72579352|NCT03656744|144687524|SUPERIORITY|||||||0.267|||||||ANCOVA|||||||0.267
72579353|NCT03656744|144687524|SUPERIORITY|||||||0.911|||||||ANCOVA|||||||0.911
72579354|NCT03656744|144687525|SUPERIORITY|||||||0.387|||||||ANCOVA|||||||0.387
72579355|NCT03656744|144687525|SUPERIORITY|||||||0.855|||||||ANCOVA|||||||0.855
72579356|NCT03656744|144687526|SUPERIORITY|||||||0.107|||||||ANCOVA|||||||0.107
72579357|NCT03656744|144687526|SUPERIORITY|||||||0.489|||||||ANCOVA|||||||0.489
72579358|NCT03656744|144687527|SUPERIORITY|||||||0.515|||||||ANCOVA|||||||0.515
72579359|NCT03656744|144687527|SUPERIORITY|||||||0.887|||||||ANCOVA|||||||0.887
72579360|NCT03656744|144687528|SUPERIORITY|||||||0.003|||||||ANCOVA|||||||0.003
72579361|NCT03656744|144687528|SUPERIORITY|||||||0.016|||||||ANCOVA|||||||0.016
72579362|NCT03656744|144687529|SUPERIORITY|||||||0.124|||||||ANCOVA|||||||0.124
72579363|NCT03656744|144687529|SUPERIORITY|||||||0.171|||||||ANCOVA|||||||0.171
72579364|NCT03295630|144687568|OTHER||Mean Difference (Final Values)|-17.7|||||TWO_SIDED|||||||||Difference (steps) between accelerometer quantified step count (thigh placement) and observed step count||||
72579365|NCT03295630|144687568|OTHER||Intraclass Correlation Coefficient|0.46|||||TWO_SIDED|95.0|-0.1|0.78||||||Correlation between accelerometer quantified step count (thigh placement) and observed step count||0.78|-0.1|
72579366|NCT03295630|144687568|OTHER||Mean Difference (Final Values)|-0.84|||||TWO_SIDED|||||||||Difference (steps) between accelerometer quantified steps (ankle placement) and observed step count||||
72579367|NCT03295630|144687568|OTHER||Intraclass Correlation Coefficient|0.99|||||TWO_SIDED|95.0|0.99|1.0||||||Correlation between accelerometer quantified steps (ankle placement) and observed steps||1.0|0.99|
72544793|NCT04147715|144618748|OTHER||Geometric Least Squares Mean Ratio|0.9598|||||TWO_SIDED|90.0|0.8585|1.073|||||Ratio = Fed / Fasted|The effect of food on the plasma PK of S-648414 was examined after a single dose of 100 mg S-648414 in the fed and fasted state using an ANOVA fitted with a linear mixed effect model, with ln-transformed AUC0-last as the dependent variable, treatment as a fixed effect, and participant as random effect. The difference and 90% CI between the fed and fasted state ln-transformed AUC0-last were estimated, then back-transformed to obtain the corresponding geometric least squares mean ratio and 90% CI.||1.0730|0.8585|
72544794|NCT04147715|144618749|OTHER||Slope|1.028|||||TWO_SIDED|95.0|0.9866|1.0695||||||The dose proportionality of plasma PK parameters of S-648414 was examined for all fasted groups in Part 1 using the power model. The power model assumes a linear relationship between the ln-transformed parameter and ln-transformed dose where ln(AUC0-inf) = Intercept + Slope × ln(Dose) + Random error||1.0695|0.9866|
72579368|NCT01950390|144687593|SUPERIORITY||Hazard Ratio (HR)|0.94||||0.383|ONE_SIDED|90.0||1.23||One-sided|Log Rank|Stratification factors of BRAF mutation status (wild type/mutation) and prior therapy (yes/no) were used in the stratified analysis|One-sided 90% Repeated Confidence Interval for Hazard Ratio with Arm A as Reference|||1.23||0.383
72579369|NCT01950390|144687594|SUPERIORITY||Hazard Ratio (HR)|0.85||||0.358|TWO_SIDED|95.0|0.61|1.2||Two-sided|Log Rank|Stratified Log rank test||||1.20|0.61|0.358
72579370|NCT01950390|144687595|SUPERIORITY|||||||0.482||||||Two-sided|Chi-squared|||||||0.482
72579371|NCT01950390|144687597|SUPERIORITY|||||||0.937||||||Two-sided|Chi-squared|||||||0.937
72579372|NCT01232452|144687653|SUPERIORITY||Hazard Ratio (HR)|1.03||||0.848|TWO_SIDED|95.0|0.73|1.47|||Log Rank|||||1.47|0.73|0.848
72579373|NCT01232452|144687654|SUPERIORITY|||||||0.338|||||||Fisher Exact|||||||0.338
72579374|NCT05024747|144687665|OTHER||Ratio T/R|96.68|||||TWO_SIDED|90.0|90.0|103.85||||||Statistical comparison was analyzed between Test vs Reference based on Baseline Adjusted Data.||103.85|90.00|
72579375|NCT05024747|144687666|OTHER||Ratio T/R|92.37|||||TWO_SIDED|90.0|85.45|99.84||||||Statistical comparison was analyzed between Test vs Reference based on Baseline Adjusted Data.||99.84|85.45|
72579376|NCT05024747|144687667|OTHER||Ratio T/R|92.54|||||TWO_SIDED|90.0|85.63|100.01||||||Statistical comparison was analyzed between Test vs Reference based on Baseline Adjusted Data.||100.01|85.63|
72579377|NCT05024747|144687668|OTHER||Hodges- Lehmann's median difference|-0.0192||||0.0833|TWO_SIDED|95.0|-0.0542|0.0044|||Wilcoxon Signed Rank Test|||Statistical comparison was analyzed between Test vs Reference.||0.0044|-0.0542|0.0833
72579378|NCT05024747|144687669|OTHER||Hodges- Lehmann's median difference|-6.0||||0.0205|TWO_SIDED|95.0|-10.5|0.0|||Wilcoxon Signed Rank Test|||Statistical comparison was analyzed between Test vs Reference.||0.0000|-10.5000|0.0205
72579379|NCT05024747|144687670|OTHER||Hodges- Lehmann's median difference|0.3225||||0.0946|TWO_SIDED|95.0|-0.0949|0.681|||Wilcoxon Signed Rank Test|||Statistical comparison was analyzed between Test vs Reference.||0.6810|-0.0949|0.0946
72579380|NCT04584684|144687682|SUPERIORITY|||||||0.89||||||The a priori threshold for statistical significance is \<0.05.|Mixed Models Analysis|||SARS CoV-2 N1||||0.89
72579381|NCT04584684|144687682|SUPERIORITY|||||||0.88||||||The a priori threshold for statistical significance is \<0.05.|Mixed Models Analysis|||SARS CoV-2 N1||||0.88
72579382|NCT04584684|144687682|SUPERIORITY|||||||0.82||||||The a priori threshold for statistical significance is \<0.05.|Mixed Models Analysis|||SARS CoV-2 N1||||0.82
72579383|NCT04584684|144687682|SUPERIORITY|||||||0.65||||||The a priori threshold for statistical significance is \<0.05.|Mixed Models Analysis|||SARS CoV-2 N1||||0.65
72579384|NCT04584684|144687682|SUPERIORITY|||||||0.77||||||The a priori threshold for statistical significance is \<0.05.|Mixed Models Analysis|||SARS CoV-2 N1||||0.77
72579385|NCT04584684|144687682|SUPERIORITY|||||||0.76||||||The a priori threshold for statistical significance is \<0.05.|Mixed Models Analysis|||SARS CoV-2 N2||||0.76
72579386|NCT04584684|144687682|SUPERIORITY|||||||0.8||||||The a priori threshold for statistical significance is \<0.05.|Mixed Models Analysis|||SARS CoV-2 N2||||0.80
72579387|NCT04584684|144687682|SUPERIORITY|||||||0.71||||||The a priori threshold for statistical significance is \<0.05.|Mixed Models Analysis|||SARS CoV-2 N2||||0.71
72579388|NCT04584684|144687682|SUPERIORITY|||||||0.6||||||The a priori threshold for statistical significance is \<0.05.|Mixed Models Analysis|||SARS CoV-2 N2||||0.60
72579389|NCT04584684|144687682|SUPERIORITY|||||||0.8||||||The a priori threshold for statistical significance is \<0.05.|Mixed Models Analysis|||SARS CoV-2 N2||||0.80
72579390|NCT02955212|144687697|SUPERIORITY||Response Rate Difference|40.2|||<|0.001|TWO_SIDED|95.0|30.5|50.0|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification factor of country.|Response Rate Difference = Upadacitinib - Placebo|||50.0|30.5|<0.001
72579391|NCT02955212|144687698|SUPERIORITY||Least Squares (LS) Mean Difference|-1.61|||<|0.001|TWO_SIDED|95.0|-1.86|-1.36|||ANCOVA|ANCOVA model including treatment as the fixed factor, and Baseline value and the stratification factor country as the covariates.|LS Mean Difference = Upadacitinib - Placebo|||-1.36|-1.86|<0.001
72579392|NCT02955212|144687699|SUPERIORITY||LS Mean Difference|-0.44|||<|0.001|TWO_SIDED|95.0|-0.55|-0.33|||ANCOVA|ANCOVA model including treatment as the fixed factor, and Baseline value and the stratification factor country as the covariates.|LS Mean Difference = Upadacitinib - Placebo|||-0.33|-0.55|<0.001
72544795|NCT04147715|144618749|OTHER||Geometric Least Squares Mean Ratio|0.9646|||||TWO_SIDED|90.0|0.8643|1.0766|||||Ratio = Fed / Fasted|The effect of food on the plasma PK of S-648414 was examined after a single dose of 100 mg S-648414 in the fed and fasted state using an ANOVA fitted with a linear mixed effect model, with ln-transformed AUC0-inf as the dependent variable, treatment as a fixed effect, and participant as random effect. The difference and 90% CI between the fed and fasted state ln-transformed AUC0-inf were estimated, then back-transformed to obtain the corresponding geometric least squares mean ratio and 90% CI.||1.0766|0.8643|
72544796|NCT04147715|144618750|OTHER||Geometric Least Squares Mean Ratio|1.0272|||||TWO_SIDED|90.0|0.9949|1.0606|||||Ratio = Fed / Fasted|The effect of food on the plasma PK of S-648414 was examined after a single dose of 100 mg S-648414 in the fed and fasted state using an ANOVA fitted with a linear mixed effect model, with ln-transformed t1/2,z as the dependent variable, treatment as a fixed effect, and participant as random effect. The difference and 90% CI between the fed and fasted state ln-transformed t1/2,z were estimated, then back-transformed to obtain the corresponding geometric least squares mean ratio and 90% CI.||1.0606|0.9949|
72544797|NCT04147715|144618757|OTHER||Geometric Least Squares Mean Ratio|1.5167|||||TWO_SIDED|90.0|1.2654|1.818|||||Ratio = 50 mg / 30 mg|"The dose proportionality of plasma S-648414 Cmax after a single dose of S-648414 (Day 1) was assessed using an ANOVA model fitted to the ln-transformed Cmax, with dose group fitted as a fixed factor.~The point estimates and 90% CIs were generated for the ratios of the 50 mg dose to 30 mg dose ln-transformed Cmax, then back-transformed to obtain the corresponding geometric least squares mean ratio and 90% CI."||1.8180|1.2654|
72544798|NCT04147715|144618757|OTHER||Geometric Least Squares Mean Ratio|1.8372|||||TWO_SIDED|90.0|1.5696|2.1506|||||Ratio = 50 mg / 30 mg|"The dose proportionality of plasma S-648414 Cmax after multiple doses of S-648414 (Day 14) was assessed using an ANOVA model fitted to the ln-transformed Cmax, with dose group fitted as a fixed factor.~The point estimates and 90% CIs were generated for the ratios of the 50 mg dose to 30 mg dose ln-transformed Cmax, then back-transformed to obtain the corresponding geometric least squares mean ratio and 90% CI."||2.1506|1.5696|
72544799|NCT04147715|144618757|OTHER||Geometric Least Squares Mean Ratio|1.7489|||||TWO_SIDED|90.0|1.525|2.0057|||||Ratio = Day 14 / Day 1|"The accumulation ratio of Cmax in the 30 mg dose group was calculated as the ratio of Day 14 to Day 1 using an ANOVA fitted with a linear mixed model with ln-transformed Cmax, Day as a fixed effect and participant as a random effect.~The difference and 90% CI between the ln-transformed Cmax on Day 1 and Day 14 were estimated then back-transformed to obtain the corresponding geometric least squares mean ratio and 90% CI."||2.0057|1.5250|
72544800|NCT04147715|144618757|OTHER||Geometric Least Squares Mean Ratio|2.1453|||||TWO_SIDED|90.0|1.9741|2.3313|||||Ratio = Day 14 / Day 1|"The accumulation ratio of Cmax in the 50 mg dose group was calculated as the ratio of Day 14 to Day 1 using an ANOVA fitted with a linear mixed model with ln-transformed Cmax, Day as a fixed effect and participant as a random effect.~The difference and 90% CI between the ln-transformed Cmax on Day 1 and Day 14 were estimated then back-transformed to obtain the corresponding geometric least squares mean ratio and 90% CI."||2.3313|1.9741|
72544801|NCT04147715|144618759|OTHER||Geometric Least Squares Mean Ratio|1.6277|||||TWO_SIDED|90.0|1.4038|1.8874|||||Ratio = 50 mg / 30 mg|"The dose proportionality of plasma S-648414 AUC0-τ after a single dose of S-648414 (Day 1) was assessed using an ANOVA model fitted to the ln-transformed AUC0-τ, with dose group fitted as a fixed factor.~The point estimates and 90% CIs were generated for the ratios of the 50 mg dose to 30 mg dose ln-transformed AUC0-τ, then back-transformed to obtain the corresponding geometric least squares mean ratio and 90% CI."||1.8874|1.4038|
72544802|NCT04147715|144618759|OTHER||Geometric Least Squares Mean Ratio|1.7454|||||TWO_SIDED|90.0|1.4785|2.0605|||||Ratio = 50 mg / 30 mg|"The dose proportionality of plasma S-648414 AUC0-τ after multiple doses of S-648414 (Day 14) was assessed using an ANOVA model fitted to the ln-transformed AUC0-τ, with dose group fitted as a fixed factor.~The point estimates and 90% CIs were generated for the ratios of the 50 mg dose to 30 mg dose ln-transformed AUC0-τ, then back-transformed to obtain the corresponding geometric least squares mean ratio and 90% CI."||2.0605|1.4785|
72579393|NCT02955212|144687700|SUPERIORITY||LS Mean Difference|5.57|||<|0.001|TWO_SIDED|95.0|4.13|7.01|||Mixed Effect Model Repeat Measurement|MMRM model with treatment, visit, treatment-by-visit interaction and stratification factor of country as fixed effects and Baseline value as covariate|LS Mean Difference = Upadacitinib - Placebo|||7.01|4.13|<0.001
72544803|NCT04147715|144618759|OTHER||Geometric Least Squares Mean Ratio|1.9102|||||TWO_SIDED|90.0|1.7788|2.0513|||||Ratio = Day 14 / Day 1|"The accumulation ratio of AUC0-τ in the 30 mg dose group was calculated as the ratio of Day 14 to Day 1 using an ANOVA fitted with a linear mixed model with ln-transformed AUC0-τ, Day as a fixed effect and participant as a random effect.~The difference and 90% CI between the ln-transformed AUC0-τ on Day 1 and Day 14 were estimated then back-transformed to obtain the corresponding geometric least squares mean ratio and 90% CI."||2.0513|1.7788|
72544804|NCT04147715|144618759|OTHER||Geometric Least Squares Mean Ratio|2.0478|||||TWO_SIDED|90.0|1.9203|2.1837|||||Ratio = Day 14 / Day 1|"The accumulation ratio of AUC0-τ in the 50 mg dose group was calculated as the ratio of Day 14 to Day 1 using an ANOVA fitted with a linear mixed model with ln-transformed AUC0-τ, Day as a fixed effect and participant as a random effect.~The difference and 90% CI between the ln-transformed AUC0-τ on Day 1 and Day 14 were estimated then back-transformed to obtain the corresponding geometric least squares mean ratio and 90% CI."||2.1837|1.9203|
72579394|NCT02955212|144687701|SUPERIORITY||Response Rate Difference|32.5|||<|0.001|TWO_SIDED|95.0|23.4|41.7|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification factor country.|Response Rate Difference = Upadacitinib - Placebo|||41.7|23.4|<0.001
72579395|NCT02955212|144687702|SUPERIORITY||Response Rate Difference|24.3|||<|0.001|TWO_SIDED|24.3|16.6|31.9|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification factor of country.|Response Rate Difference = Upadacitinib - Placebo|||31.9|16.6|<0.001
72579396|NCT02955212|144687703|SUPERIORITY||Response Rate Difference|24.3|||<|0.001|TWO_SIDED|95.0|15.6|32.9|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification factor of country.|Response Rate Difference = Upadacitinib - Placebo|||32.9|15.6|<0.001
72544805|NCT04147715|144618766|OTHER|The drug interaction was assessed by whether the 90% CIs for the geometric least squares mean ratio of Cmax, AUC0-last, and AUC0-inf of midazolam were completely contained within the range of 0.8000 to 1.2500.|Geometric Least Squares Mean Ratio|0.9241|||||TWO_SIDED|90.0|0.8057|1.06|||||Ratio = 30 mg S-648414 + Midazolam / Midazolam|The effect of S-648414 on the PK of midazolam (a CYP3A substrate) was assessed using an ANOVA fitted with a linear mixed effect model with ln-transformed Cmax as the dependent variable, treatment as a fixed effect, and participant as a random effect. The difference and 90% CI between the ln-transformed Cmax of midazolam plus S-648414 and midazolam alone was estimated then back-transformed to obtain the corresponding geometric least squares mean ratios and 90% CIs.||1.0600|0.8057|
72544806|NCT04147715|144618766|OTHER|The drug interaction was assessed by whether the 90% CIs for the geometric least squares mean ratio of Cmax, AUC0-last, and AUC0-inf of midazolam were completely contained within the range of 0.8000 to 1.2500.|Geometric Least Squares Mean Ratio|1.0303|||||TWO_SIDED|90.0|0.9299|1.1415|||||Ratio = 50 mg S-648414 + Midazolam / Midazolam|The effect of S-648414 on the PK of midazolam (a CYP3A substrate) was assessed using an ANOVA fitted with a linear mixed effect model with ln-transformed Cmax as the dependent variable, treatment as a fixed effect, and participant as a random effect. The difference and 90% CI between the ln-transformed Cmax of midazolam plus S-648414 and midazolam alone was estimated then back-transformed to obtain the corresponding geometric least squares mean ratios and 90% CIs.||1.1415|0.9299|
72579397|NCT02955212|144687704|SUPERIORITY||Response Rate Difference|32.5|||<|0.001|TWO_SIDED|95.0|24.0|41.0|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification factor of country.|Response Rate Difference = Upadacitinib - Placebo|||41.0|24.0|<0.001
72579398|NCT02955212|144687705|SUPERIORITY||Response Rate Difference|17.8|||<|0.001|TWO_SIDED|95.0|11.0|24.5|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification factor of country.|Response Rate Difference = Upadacitinib - Placebo|||24.5|11.0|<0.001
72579399|NCT02955212|144687706|SUPERIORITY||Response Rate Difference|19.5|||<|0.001|TWO_SIDED|95.0|12.1|27.0|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification factor of country|Response Rate Difference = Upadacitinib - Placebo|||27.0|12.1|<0.001
72579400|NCT02664181|144687710|SUPERIORITY|||||||0.05|||||||Fisher Exact|||Partial remission rate was compared between both arms. The null hypothesis is that there is no difference in partial remission rate between the two arms, with a p-value of \< 0.05 indicating significance||||0.05
72579401|NCT02664181|144687711|SUPERIORITY||Hazard Ratio (HR)|0.4||||0.06|TWO_SIDED|95.0|0.13|1.21|||Log Rank|||||1.21|0.13|0.06
72579402|NCT02664181|144687712|SUPERIORITY||Hazard Ratio (HR)|0.4||||0.19|TWO_SIDED|95.0|0.11|1.62|||Log Rank||Data from Kaplan-Meier analyses|||1.62|0.11|0.19
72579403|NCT02556801|144687748|SUPERIORITY||Test statistic|1.823||||0.057|ONE_SIDED||||||MCP-Mod Method|The primary dose-response analysis was performed by applying linear, Emax, logistic and exponential models.The p-value was based on Emax model.||||||0.057
72579404|NCT02556801|144687748|SUPERIORITY||Treatment effect|-1.96|STANDARD_DEVIATION|1.17|||TWO_SIDED|90.0|-3.89|-0.03||||||||-0.03|-3.89|
72579405|NCT02556801|144687748|SUPERIORITY||Treatment effect|-1.83|STANDARD_ERROR_OF_MEAN|1.14|||TWO_SIDED|90.0|-3.72|0.06||||||||0.06|-3.72|
72579406|NCT02556801|144687748|SUPERIORITY||Treatment effect|-2.33|STANDARD_ERROR_OF_MEAN|1.15|||TWO_SIDED|90.0|-4.23|-0.43||||||||-0.43|-4.23|
72579407|NCT02556801|144687749|SUPERIORITY||Treatment effect|-1.92|STANDARD_ERROR_OF_MEAN|1.17|=|0.051|TWO_SIDED|90.0|-3.85|0.01|||Mixed Models Analysis|||||0.01|-3.85|=0.051
72579408|NCT02556801|144687749|SUPERIORITY||Treatment effect|-1.79|STANDARD_ERROR_OF_MEAN|1.14||0.059|TWO_SIDED|90.0|-3.68|0.1|||Mixed Models Analysis|||||0.10|-3.68|0.059
72579409|NCT02556801|144687749|SUPERIORITY||Treatment effect|-2.3|STANDARD_ERROR_OF_MEAN|1.15||0.024|TWO_SIDED|90.0|-4.2|-0.4|||Mixed Models Analysis|||||-0.40|-4.20|0.024
72579410|NCT02556801|144687750|SUPERIORITY||Treatment effect|-0.6|STANDARD_ERROR_OF_MEAN|1.08||0.291|TWO_SIDED|90.0|-2.39|1.19|||Mixed Models Analysis|||||1.19|-2.39|0.291
72579411|NCT02556801|144687750|SUPERIORITY||Treatment effect|-1.84|STANDARD_ERROR_OF_MEAN|1.06|=|0.042|TWO_SIDED|90.0|-3.6|-0.09|||Mixed Models Analysis|||||-0.09|-3.60|=0.042
72579412|NCT02556801|144687750|SUPERIORITY||Treatment effect|-1.78|STANDARD_ERROR_OF_MEAN|1.08||0.05|TWO_SIDED|90.0|-3.56|0.0|||Mixed Models Analysis|||||0.00|-3.56|0.050
72579413|NCT02556801|144687751|SUPERIORITY||Treatment effect|-0.89|STANDARD_ERROR_OF_MEAN|0.63|=|0.079|TWO_SIDED|90.0|-1.93|0.15|||Mixed Models Analysis|||||0.15|-1.93|=0.079
72579414|NCT02556801|144687751|SUPERIORITY||Treatment effect|-0.88|STANDARD_ERROR_OF_MEAN|0.61|=|0.076|TWO_SIDED|90.0|-1.89|0.13|||Mixed Models Analysis|||||0.13|-1.89|=0.076
72579415|NCT02556801|144687751|SUPERIORITY||Treatment effect|-1.11|STANDARD_ERROR_OF_MEAN|0.62|=|0.038|TWO_SIDED|0.62|-2.13|-0.08|||Mixed Models Analysis|||||-0.08|-2.13|=0.038
72579416|NCT02556801|144687752|SUPERIORITY||Treatment effect|-0.07|STANDARD_ERROR_OF_MEAN|0.58|=|0.451|TWO_SIDED|90.0|-1.03|0.88|||Mixed Models Analysis|||||0.88|-1.03|=0.451
72579417|NCT02556801|144687752|SUPERIORITY||Treatment effect|-0.62|STANDARD_ERROR_OF_MEAN|0.56|=|0.137|TWO_SIDED|90.0|-1.55|0.32|||Mixed Models Analysis|||||0.32|-1.55|=0.137
72579418|NCT02556801|144687752|SUPERIORITY||Treatment effect|-0.5|STANDARD_ERROR_OF_MEAN|0.57|=|0.195|TWO_SIDED|90.0|-1.45|0.46|||Mixed Models Analysis|||||0.46|-1.45|=0.195
72579419|NCT02556801|144687753|SUPERIORITY||Treatment effect|-0.354|STANDARD_ERROR_OF_MEAN|0.183|=|0.028|TWO_SIDED|90.0|-0.657|-0.05|||ANOVA|||||-0.050|-0.657|=0.028
72579420|NCT02556801|144687753|SUPERIORITY||Treatment effect|-0.394|STANDARD_ERROR_OF_MEAN|0.186|=|0.018|TWO_SIDED|90.0|-0.702|-0.086|||ANOVA|||||-0.086|-0.702|=0.018
72579421|NCT02556801|144687753|SUPERIORITY||Treatment effect|-0.28|STANDARD_ERROR_OF_MEAN|0.182|=|0.063|TWO_SIDED|90.0|-0.581|0.021|||ANOVA|||||0.021|-0.581|=0.063
72579422|NCT02556801|144687754|SUPERIORITY||Treatment effect|1.92|||<|0.001|TWO_SIDED|90.0|1.41|2.6|||Mixed Models Analysis|||Analysis of change from baseline of serum specific IgE levels after 5 months (Visit 4)||2.60|1.41|<0.001
72579423|NCT02556801|144687754|SUPERIORITY||Treatment effect|2.43|||<|0.001|TWO_SIDED|90.0|1.8|3.27|||Mixed Models Analysis|||Analysis of change from baseline of serum specific IgE levels after 5 months (Visit 4)||3.27|1.80|<0.001
72579424|NCT02556801|144687754|SUPERIORITY||Treatment effect|2.34|||<|0.001|TWO_SIDED|90.0|1.73|3.15|||Mixed Models Analysis|||Analysis of change from baseline of serum specific IgE levels after 5 months (Visit 4)||3.15|1.73|<0.001
72579425|NCT02556801|144687754|SUPERIORITY||Treatment effect|1.42||||0.029|TWO_SIDED|90.0|1.05|1.93|||Mixed Models Analysis|||Analysis of change from baseline of serum specific IgE levels after 10 months (Visit 6)||1.93|1.05|0.029
72579426|NCT02556801|144687754|SUPERIORITY||Treatment effect|1.67||||0.003|TWO_SIDED|90.0|1.24|2.25|||Mixed Models Analysis|||Analysis of change from baseline of serum specific IgE levels after 10 months (Visit 6)||2.25|1.24|0.003
72579427|NCT02556801|144687754|SUPERIORITY||Treatment effect|1.37||||0.042|TWO_SIDED|90.0|1.01|1.85|||Mixed Models Analysis|||Analysis of change from baseline of serum specific IgE levels after 10 months (Visit 6)||1.85|1.01|0.042
72579428|NCT02556801|144687755|SUPERIORITY||Treatment effect|1.11||||0.057|TWO_SIDED|90.0|1.0|1.23|||Mixed Models Analysis|||Analysis of change from baseline of serum specific IgG ATG levels after 5 months (Visit 4)||1.23|1.00|0.057
72579429|NCT02556801|144687755|SUPERIORITY||Treatment effect|1.29|||<|0.001|TWO_SIDED|90.0|1.17|1.43|||Mixed Models Analysis|||Analysis of change from baseline of serum specific IgG ATG levels after 5 months (Visit 4)||1.43|1.17|<0.001
72579430|NCT02556801|144687755|SUPERIORITY||Treatment effect|1.24|||<|0.001|TWO_SIDED|90.0|1.12|1.37|||Mixed Models Analysis|||Analysis of change from baseline of serum specific IgG ATG levels after 5 months (Visit 4)||1.37|1.12|<0.001
72329493|NCT00443872|144184448|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.5|STANDARD_DEVIATION|1.0|<|0.01|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||Comparison of mean group scores at baseline and 12 weeks||||<0.01
72579431|NCT02556801|144687755|SUPERIORITY||Treatment effect|1.23||||0.015|TWO_SIDED|90.0|1.05|1.45|||Mixed Models Analysis|||Analysis of change from baseline of serum specific IgG ATG levels after 10 months (Visit 6)||1.45|1.05|0.015
72579432|NCT02556801|144687755|SUPERIORITY||Treatment effect|1.6|||<|0.001|TWO_SIDED|90.0|1.37|1.87|||Mixed Models Analysis|||Analysis of change from baseline of serum specific IgG ATG levels after 10 months (Visit 6)||1.87|1.37|<0.001
72579433|NCT02556801|144687755|SUPERIORITY||Treatment effect|1.39|||<|0.001|TWO_SIDED|90.0|1.19|1.62|||Mixed Models Analysis|||Analysis of change from baseline of serum specific IgG ATG levels after 10 months (Visit 6)||1.62|1.19|<0.001
72579434|NCT02556801|144687755|SUPERIORITY||Treatment effect|0.99||||0.341|TWO_SIDED|90.0|0.93|1.04|||Mixed Models Analysis|||Analysis of change from baseline of serum specific IgG AP1 levels after 5 months (Visit 4)||1.04|0.93|0.341
72579435|NCT02556801|144687755|SUPERIORITY||Treatment effect|1.1||||0.003|TWO_SIDED|90.0|1.04|1.16|||Mixed Models Analysis|||Analysis of change from baseline of serum specific IgG AP1 levels after 5 months (Visit 4)||1.16|1.04|0.003
72579436|NCT02556801|144687755|SUPERIORITY||Treatment effect|1.02||||0.269|TWO_SIDED|90.0|0.97|1.08|||Mixed Models Analysis|||Analysis of change from baseline of serum specific IgG AP1 levels after 5 months (Visit 4)||1.08|0.97|0.269
72579437|NCT02556801|144687755|SUPERIORITY||Treatment effect|1.02||||0.312|TWO_SIDED|90.0|0.95|1.1|||Mixed Models Analysis|||Analysis of change from baseline of serum specific IgG AP1 levels after 10 months (Visit 6)||1.10|0.95|0.312
72579438|NCT02556801|144687755|SUPERIORITY||Treatment effect|1.22|||<|0.001|TWO_SIDED|90.0|1.13|1.31|||Mixed Models Analysis|||Analysis of change from baseline of serum specific IgG AP1 levels after 10 months (Visit 6)||1.31|1.13|<0.001
72579439|NCT02556801|144687755|SUPERIORITY||Treatment effect|1.11||||0.008|TWO_SIDED|90.0|1.03|1.2|||Mixed Models Analysis|||Analysis of change from baseline of serum specific IgG AP1 levels after 10 months (Visit 6)||1.20|1.03|0.008
72579440|NCT02556801|144687755|SUPERIORITY||Treatment effect|1.04||||0.212|TWO_SIDED|90.0|0.96|1.14|||Mixed Models Analysis|||Analysis of change from baseline of serum specific IgG AP5 levels after 5 months (Visit 4)||1.14|0.96|0.212
72579441|NCT02556801|144687755|SUPERIORITY||Treatment effect|1.16||||0.002|TWO_SIDED|90.0|1.07|1.27|||Mixed Models Analysis|||Analysis of change from baseline of serum specific IgG AP5 levels after 5 months (Visit 4)||1.27|1.07|0.002
72579442|NCT02556801|144687755|SUPERIORITY||Treatment effect|1.15||||0.004|TWO_SIDED|90.0|1.06|1.25|||Mixed Models Analysis|||Analysis of change from baseline of serum specific IgG AP5 levels after 5 months (Visit 4)||1.25|1.06|0.004
72579443|NCT02556801|144687755|SUPERIORITY||Treatment effect|1.09||||0.126|TWO_SIDED|90.0|0.96|1.24|||Mixed Models Analysis|||Analysis of change from baseline of serum specific IgG AP5 levels after 10 months (Visit 6)||1.24|0.96|0.126
72579444|NCT02556801|144687755|SUPERIORITY||Treatment effect|1.28|||<|0.001|TWO_SIDED|90.0|1.13|1.45|||Mixed Models Analysis|||Analysis of change from baseline of serum specific IgG AP5 levels after 10 months (Visit 6)||1.45|1.13|<0.001
72579445|NCT02556801|144687755|SUPERIORITY||Treatment effect|1.26||||0.002|TWO_SIDED|90.0|1.11|1.43|||Mixed Models Analysis|||Analysis of change from baseline of serum specific IgG AP5 levels after 10 months (Visit 6)||1.43|1.11|0.002
72579446|NCT02556801|144687756|SUPERIORITY||Treatment effect|1.33||||0.032|TWO_SIDED|90.0|1.03|1.7|||Mixed Models Analysis|||Analysis of change from baseline of serum specific IgG4 ATG levels after 5 months (Visit 4)||1.70|1.03|0.032
72579447|NCT02556801|144687756|SUPERIORITY||Treatment effect|2.15|||<|0.001|TWO_SIDED|90.0|1.68|2.74|||Mixed Models Analysis|||Analysis of change from baseline of serum specific IgG4 ATG levels after 5 months (Visit 4)||2.74|1.68|<0.001
72411430|NCT03207750|144331231|NON_INFERIORITY|Lower limit (LL) of the two-sided 95% CI on GMC ratios (HRV PCV-free Liquid group over HRV Lyophilized group) for S. pneumoniae serotype 9V should be ≥ 0.5.|GMC ratio|1.03|||||TWO_SIDED|95.0|0.93|1.14|||ANOVA|ANOVA model that included the vaccine group as fixed effect.||Non-inferiority of the immune responses to 3 doses of Pediarix, Hiberix and Prevenar 13 when co-administered with 2 doses of the PCV-free liquid HRV vaccine, as compared to when co-administered with lyophilized HRV vaccine in terms of GMC ratios for Streptococcus pneumoniae (S. pneumoniae) serotype 9V.||1.14|0.93|
72579448|NCT02556801|144687756|SUPERIORITY||Treatment effect|2.03|||<|0.001|TWO_SIDED|90.0|1.59|2.59|||Mixed Models Analysis|||Analysis of change from baseline of serum specific IgG4 ATG levels after 5 months (Visit 4)||2.59|1.59|<0.001
72579449|NCT02556801|144687756|SUPERIORITY||Treatment effect|1.48||||0.024|TWO_SIDED|90.0|1.07|2.06|||Mixed Models Analysis|||Analysis of change from baseline of serum specific IgG4 ATG levels after 10 months (Visit 6)||2.06|1.07|0.024
72579450|NCT02556801|144687756|SUPERIORITY||Treatment effect|2.88|||<|0.001|TWO_SIDED|90.0|2.09|3.98|||Mixed Models Analysis|||Analysis of change from baseline of serum specific IgG4 ATG levels after 10 months (Visit 6)||3.98|2.09|<0.001
72579451|NCT02556801|144687756|SUPERIORITY||Treatment effect|2.12|||<|0.001|TWO_SIDED|90.0|1.54|2.93|||Mixed Models Analysis|||Analysis of change from baseline of serum specific IgG4 ATG levels after 10 months (Visit 6)||2.93|1.54|<0.001
72579452|NCT02556801|144687756|SUPERIORITY||Treatment effect|1.18||||0.102|TWO_SIDED|90.0|0.95|1.47|||Mixed Models Analysis|||Analysis of change from baseline of serum specific IgG4 AP1 levels after 5 months (Visit 4)||1.47|0.95|0.102
72579453|NCT02556801|144687756|SUPERIORITY||Treatment effect|1.99|||<|0.001|TWO_SIDED|90.0|1.61|2.46|||Mixed Models Analysis|||Analysis of change from baseline of serum specific IgG4 AP1 levels after 5 months (Visit 4)||2.46|1.61|<0.001
72411431|NCT03207750|144331231|NON_INFERIORITY|Lower limit (LL) of the two-sided 95% CI on GMC ratios (HRV PCV-free Liquid group over HRV Lyophilized group) for S. pneumoniae serotype 14 should be ≥ 0.5.|GMC ratio|1.0|||||TWO_SIDED|95.0|0.89|1.13|||ANOVA|ANOVA model that included the vaccine group as fixed effect.||Non-inferiority of the immune responses to 3 doses of Pediarix, Hiberix and Prevenar 13 when co-administered with 2 doses of the PCV-free liquid HRV vaccine, as compared to when co-administered with lyophilized HRV vaccine in terms of GMC ratios for Streptococcus pneumoniae (S. pneumoniae) serotype 14.||1.13|0.89|
72579454|NCT02556801|144687756|SUPERIORITY||Treatment effect|1.57|||<|0.001|TWO_SIDED|90.0|1.27|1.94|||Mixed Models Analysis|||Analysis of change from baseline of serum specific IgG4 AP1 levels after 5 months (Visit 4)||1.94|1.27|<0.001
72579455|NCT02556801|144687756|SUPERIORITY||Treatment effect|1.39||||0.019|TWO_SIDED|90.0|1.07|1.81|||Mixed Models Analysis|||Analysis of change from baseline of serum specific IgG4 AP1 levels after 10 months (Visit 6)||1.81|1.07|0.019
72579456|NCT02556801|144687756|SUPERIORITY||Treatment effect|2.38|||<|0.001|TWO_SIDED|90.0|1.84|3.08|||Mixed Models Analysis|||Analysis of change from baseline of serum specific IgG4 AP1 levels after 10 months (Visit 6)||3.08|1.84|<0.001
72579457|NCT02556801|144687756|SUPERIORITY||Treatment effect|1.7|||<|0.001|TWO_SIDED|90.0|1.31|2.19|||Mixed Models Analysis|||Analysis of change from baseline of serum specific IgG4 AP1 levels after 10 months (Visit 6)||2.19|1.31|<0.001
72579458|NCT02556801|144687756|SUPERIORITY||Treatment effect|1.52||||0.048|TWO_SIDED|90.0|1.01|2.31|||Mixed Models Analysis|||Analysis of change from baseline of serum specific IgG4 AP5 levels after 5 months (Visit 4)||2.31|1.01|0.048
72329494|NCT00443872|144184449|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.0|||<|0.01|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.01
72579459|NCT02556801|144687756|SUPERIORITY||Treatment effect|2.35|||<|0.001|TWO_SIDED|90.0|1.56|3.53|||Mixed Models Analysis|||Analysis of change from baseline of serum specific IgG4 AP5 levels after 5 months (Visit 4)||3.53|1.56|<0.001
72579460|NCT02556801|144687756|SUPERIORITY||Treatment effect|2.83|||<|0.001|TWO_SIDED|90.0|1.88|4.24|||Mixed Models Analysis|||Analysis of change from baseline of serum specific IgG4 AP5 levels after 5 months (Visit 4)||4.24|1.88|<0.001
72579461|NCT02556801|144687756|SUPERIORITY||Treatment effect|1.67||||0.04|TWO_SIDED|90.0|1.03|2.69|||Mixed Models Analysis|||Analysis of change from baseline of serum specific IgG4 AP5 levels after 10 months (Visit 6)||2.69|1.03|0.040
72411432|NCT03207750|144331231|NON_INFERIORITY|Lower limit (LL) of the two-sided 95% CI on GMC ratios (HRV PCV-free Liquid group over HRV Lyophilized group) for S. pneumoniae serotype 18C should be ≥ 0.5.|GMC ratio|1.03|||||TWO_SIDED|95.0|0.92|1.14|||ANOVA|ANOVA model that included the vaccine group as fixed effect.||Non-inferiority of the immune responses to 3 doses of Pediarix, Hiberix and Prevenar 13 when co-administered with 2 doses of the PCV-free liquid HRV vaccine, as compared to when co-administered with lyophilized HRV vaccine in terms of GMC ratios for Streptococcus pneumoniae (S. pneumoniae) serotype 18C.||1.14|0.92|
72411433|NCT03207750|144331231|NON_INFERIORITY|Lower limit (LL) of the two-sided 95% CI on GMC ratios (HRV PCV-free Liquid group over HRV Lyophilized group) for S. pneumoniae serotype 19A should be ≥ 0.5.|GMC ratio|1.04|||||TWO_SIDED|95.0|0.93|1.15|||ANOVA|ANOVA model that included the vaccine group as fixed effect.||Non-inferiority of the immune responses to 3 doses of Pediarix, Hiberix and Prevenar 13 when co-administered with 2 doses of the PCV-free liquid HRV vaccine, as compared to when co-administered with lyophilized HRV vaccine in terms of GMC ratios for Streptococcus pneumoniae (S. pneumoniae) serotype 19A.||1.15|0.93|
72411434|NCT03207750|144331231|NON_INFERIORITY|Lower limit (LL) of the two-sided 95% CI on GMC ratios (HRV PCV-free Liquid group over HRV Lyophilized group) for S. pneumoniae serotype 19F should be ≥ 0.5.|GMC ratio|1.03|||||TWO_SIDED|95.0|0.95|1.12|||ANOVA|ANOVA model that included the vaccine group as fixed effect.||Non-inferiority of the immune responses to 3 doses of Pediarix, Hiberix and Prevenar 13 when co-administered with 2 doses of the PCV-free liquid HRV vaccine, as compared to when co-administered with lyophilized HRV vaccine in terms of GMC ratios for Streptococcus pneumoniae (S. pneumoniae) serotype 19F.||1.12|0.95|
72411435|NCT03207750|144331231|NON_INFERIORITY|Lower limit (LL) of the two-sided 95% CI on GMC ratios (HRV PCV-free Liquid group over HRV Lyophilized group) for S. pneumoniae serotype 23F should be ≥ 0.5.|GMC ratio|0.98|||||TWO_SIDED|95.0|0.87|1.1|||ANOVA|ANOVA model that included the vaccine group as fixed effect.||Non-inferiority of the immune responses to 3 doses of Pediarix, Hiberix and Prevenar 13 when co-administered with 2 doses of the PCV-free liquid HRV vaccine, as compared to when co-administered with lyophilized HRV vaccine in terms of GMC ratios for Streptococcus pneumoniae (S. pneumoniae) serotype 23F.||1.10|0.87|
72544807|NCT04147715|144618768|OTHER|The drug interaction was assessed by whether the 90% CIs for the geometric least squares mean ratio of Cmax, AUC0-last, and AUC0-inf of midazolam were completely contained within the range of 0.8000 to 1.2500|Geometric Least Squares Mean Ratio|0.842|||||TWO_SIDED|90.0|0.6628|1.0696|||||Ratio = 30 mg S-648414 + Midazolam / Midazolam|The effect of S-648414 on the PK of midazolam (a CYP3A substrate) was assessed using an ANOVA fitted with a linear mixed effect model with ln-transformed AUC0-last as the dependent variable, treatment as a fixed effect, and participant as a random effect. The difference and 90% CI between the ln-transformed AUC0-last of midazolam plus S-648414 and midazolam alone was estimated then back-transformed to obtain the corresponding geometric least squares mean ratios and 90% CIs.||1.0696|0.6628|
72411436|NCT03207750|144331232|NON_INFERIORITY|Lower limit (LL) of the two-sided asymptotic standardized 95% CI for the difference in seroprotective concentrations (HRV PCV-free Liquid group minus HRV Lyophilized group) for each of anti-PRP antibodies should be ≥-5%.|Difference in anti-PRP concentration|0.17|||||TWO_SIDED|95.0|-1.94|2.28||||||Non-inferiority of the immune responses to 3 doses of Pediarix, Hiberix and Prevenar 13 when co-administered with 2 doses of the PCV-free liquid HRV vaccine, as compared to when co-administered with lyophilized HRV vaccine in terms of group difference in percentage of subjects with concentrations (≥ 0.15 µg/mL) of anti-PRP antibodies.||2.28|-1.94|
72579462|NCT02556801|144687756|SUPERIORITY||Treatment effect|2.68|||<|0.001|TWO_SIDED|90.0|1.67|4.3|||Mixed Models Analysis|||Analysis of change from baseline of serum specific IgG4 AP5 levels after 10 months (Visit 6)||4.30|1.67|<0.001
72579463|NCT02556801|144687756|SUPERIORITY||Treatment effect|2.88|||<|0.001|TWO_SIDED|90.0|1.8|4.62|||Mixed Models Analysis|||Analysis of change from baseline of serum specific IgG4 AP5 levels after 10 months (Visit 6)||4.62|1.80|<0.001
72579464|NCT03668808|144687759|SUPERIORITY||||||<|0.05||||||The threshold for statistical significance was p=0.05.|t-test, 2 sided|||Null hypothesis is there was no difference in Time in Range (70-140mg/dl) in the initial 24 hours at destination, whether after Eastward travel or Westward travel, between Insulin Degludec \& Insulin Glargine U100. Travel direction not tested. Criterion for significance set at 0.05; using paired t-test analysis, a sample size of 21 subjects would achieve a power of at least 77% to detect a difference of 10% between basal insulins assuming the standard deviation of the difference is \<106 minutes.||||<0.05
72579465|NCT03668808|144687760|SUPERIORITY||||||<|0.05||||||The threshold for statistical significance was p=0.05|t-test, 2 sided|||Null hypothesis is there was no difference in Time in Range (70-180mg/dl) in the initial 24 hours at destination, whether after Eastward travel or Westward travel, between Insulin Degludec \& Insulin Glargine U100. Travel direction not tested. Criterion for significance set at 0.05; using paired t-test analysis, a sample size of 21 subjects would achieve a power of at least 77% to detect a difference of 10% between basal insulins assuming the standard deviation of the difference is \<106 minutes.||||<0.05
72579466|NCT03668808|144687761|SUPERIORITY||||||<|0.05||||||The threshold for statistical significance was p=0.05.|t-test, 2 sided|||Null hypothesis is there was no difference in Mean ± SD CGM glucose (mg/dl) in flight, East or West travel, and in 72 hours at destination, whether after East or West travel, between Insulin Degludec \& Insulin Glargine U100. Travel direction not tested. Criterion for significance was at 0.05. Using paired t-test analysis, a sample size of 21 subjects would achieve a power of at least 77% to detect a difference of 10% between basal insulins assuming the SD of the difference is \<106 minutes.||||<0.05
72579467|NCT03668808|144687762|SUPERIORITY||||||<|0.05||||||The threshold for statistical significance was p=0.05.|t-test, 2 sided|||Null hypothesis is that there was no difference in CGM % time \<70 mg/dl in flight, East or West travel, and in 72 hours at destination, whether after East or West travel, between Insulin Degludec and Insulin Glargine U100. Travel direction not tested. Criterion for significance was at 0.05. Using paired t-test analysis, a sample size of 21 subjects would achieve a power of at least 77% to detect a difference of 10% between basal insulins assuming the SD of the difference is \<106 minutes.||||<0.05
72579468|NCT03668808|144687763|SUPERIORITY||||||<|0.05||||||The threshold for statistical significance was p=0.05.|t-test, 2 sided|||Null hypothesis is that there was no difference in CGM % time 70-180 mg/dl in flight, East or West travel, and in 72 hours at destination, whether after East or West travel, between Insulin Degludec \& Insulin Glargine U100. Travel direction not tested. Criterion for significance was at 0.05. Using paired t-test analysis, a sample size of 21 subjects would achieve a power of at least 77% to detect a difference of 10% between basal insulins assuming the SD of the difference is \<106 minutes.||||<0.05
72579469|NCT03668808|144687764|SUPERIORITY||||||<|0.05||||||The threshold for statistical significance was p=0.05.|t-test, 2 sided|||Null hypothesis is that there was no difference in CGM % time \>180 mg/dl in flight, East or West travel, and in 72 hours at destination, whether after East or West travel, between Insulin Degludec \& Insulin Glargine U100. Travel direction not tested. Criterion for significance was at 0.05. Using paired t-test analysis, a sample size of 21 subjects would achieve a power of at least 77% to detect a difference of 10% between basal insulins assuming the SD of the difference is \<106 minutes.||||<0.05
72579470|NCT03668808|144687765|SUPERIORITY||||||<|0.05||||||The threshold for statistical significance was p=0.05.|t-test, 2 sided|||Null hypothesis is there was no difference in CGM - Coefficient of Variation (CV) in flight, East or West travel, and in 72 hours at destination, whether after East or West travel, between Insulin Degludec \& Insulin Glargine U100. Travel direction not tested. Criterion for significance was at 0.05. Using paired t-test analysis, a sample size of 21 subjects would achieve a power of at least 77% to detect a difference of 10% between basal insulins assuming the SD of the difference is \<106 minutes.||||<0.05
72579471|NCT03668808|144687766|SUPERIORITY||||||<|0.05||||||The threshold for statistical significance was p=0.05.|t-test, 2 sided|||Null hypothesis is there was no difference in CGM Fasting Blood Glucose (FBG) at 0600 local time at destination, whether after East or West travel, between Insulin Degludec and Insulin Glargine U100. Travel direction not tested. Criterion for significance was set at 0.05, and using a paired t-test analysis, a sample size of 21 subjects would achieve a power of at least 77% to detect a difference of 10% between basal insulins assuming the standard deviation of the difference is \<106 minutes.||||<0.05
72579472|NCT03668808|144687767|SUPERIORITY||||||<|0.01||||||The threshold for statistical significance was p=0.05.|t-test, 2 sided|||Null hypothesis is that there was no difference in Liverpool Jet-Lag Questionnaire after 24 and 48 hours at the destination, whether after Eastward travel or after Westward travel, between Insulin Degludec and Insulin Glargine U100. Travel direction not tested. The criterion for significance was set at 0.05, and using a paired t-test analysis, a sample size of 21 subjects would achieve a power of at least 77% to detect a difference of 10% between basal insulins.||||<0.01
72579473|NCT03668808|144687768|SUPERIORITY||||||<|0.05||||||The tests were performed with a significance level of 0.05 (two-sided).|Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in Sleep quantity measured by ActiGraph in 24 hours at the destination, whether after Eastward or after Westward travel, between Insulin Degludec and Insulin Glargine U100. Travel direction not tested. The criterion for significance was set at 0.05, and using a paired t-test analysis, a sample size of 21 subjects would achieve a power of at least 77% to detect a difference of 10% between basal insulins.||||<0.05
72579474|NCT03668808|144687769|SUPERIORITY||||||<|0.05||||||The tests were performed with a significance level of 0.05 (two-sided).|Wilcoxon (Mann-Whitney)|||Null hypothesis is there was no difference in Sleep efficiency measured by ActiGraph in 24 hours at the destination, whether after Eastward or after Westward travel, between Insulin Degludec and Insulin Glargine U100. Travel direction not tested. The criterion for significance was set at 0.05, and using a paired t-test analysis, a sample size of 21 subjects would achieve a power of at least 77% to detect a difference of 10% between basal insulins.||||<0.05
72579475|NCT05274178|144687770|OTHER||||||>|0.05|||||||t-test, 2 sided|||||||>.05
72579476|NCT05274178|144687770|OTHER||||||>|0.05|||||||t-test, 2 sided|||||||>.05
72579477|NCT02839772|144687773|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.581|STANDARD_ERROR_OF_MEAN|0.296|<|0.001|TWO_SIDED|95.0|0.997|2.164|||Mixed Models Analysis|t=5.341, df=89.347||"The null hypothesis was that an evidence-based skin care intervention with added glycerine does not improve skin barrier function (SBF) in the legs/feet or enhance the disease related quality of life of Ethiopian people with podoconiosis when compared to the control group using the current skin care regimen.~Statistical analysis compared the changes in TEWL at the top of the outer lower legs by group from baseline after 3 months of interventions."||2.164|0.997|<0.001
72579478|NCT02839772|144687774|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.684|STANDARD_ERROR_OF_MEAN|0.346|<|0.001|TWO_SIDED|95.0|1.002|2.367|||Mixed Models Analysis|t=4.871, df=189.789||"The null hypothesis was that an evidence-based skin care intervention with added glycerine does not improve skin barrier function in the legs/feet or enhance the disease related quality of life of Ethiopian people with podoconiosis when compared to the control group using the current skin care regimen.~Statistical analysis compared the changes in TEWL at the mid-point of the outer lower legs by group from baseline after 3 months of interventions."||2.367|1.002|<0.001
72579479|NCT02839772|144687775|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.97|STANDARD_ERROR_OF_MEAN|0.386|<|0.001|TWO_SIDED|95.0|1.21|2.731|||Mixed Models Analysis|t=5.111, df=189.620||"The null hypothesis was that an evidence-based skin care intervention with added glycerine does not improve skin barrier function in the legs/feet or enhance the disease related quality of life of Ethiopian people with podoconiosis when compared to the control group using the current skin care regimen.~Statistical analysis compared the changes in TEWL at the base of the outer lower legs by group from baseline after 3 months of interventions."||2.731|1.210|<0.001
72579480|NCT02839772|144687776|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.751|STANDARD_ERROR_OF_MEAN|0.39||0.002|TWO_SIDED|95.0|0.656|2.846|||Mixed Models Analysis|t=3.154, df=189.580||"The null hypothesis was that an evidence-based skin care intervention with added glycerine does not improve skin barrier function in the legs/feet or enhance the disease related quality of life of Ethiopian people with podoconiosis when compared to the control group using the current skin care regimen.~Statistical analysis compared the changes in TEWL at the top of the feet by group from baseline after 3 months of interventions."||2.846|0.656|0.002
72579481|NCT02839772|144687777|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.075|STANDARD_ERROR_OF_MEAN|0.515|<|0.001|TWO_SIDED|95.0|-3.042|-1.1078|||Mixed Models Analysis|t=-4.236,df=165.310||"The null hypothesis was that an evidence-based skin care intervention with added glycerine does not improve skin barrier function in the legs/feet or enhance the disease related quality of life of Ethiopian people with podoconiosis when compared to the control group using the current skin care regimen.~Statistical analysis compared the changes in SCH at the top of the outer lower legs by group from baseline after 3 months of interventions."||-1.1078|-3.042|<0.001
72579482|NCT02839772|144687778|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.658|STANDARD_ERROR_OF_MEAN|0.467|<|0.001|TWO_SIDED|95.0|-2.581|-0.736|||Mixed Models Analysis|t=-3.549, df=180.923||"The null hypothesis was that an evidence-based skin care intervention with added glycerine does not improve skin barrier function in the legs/feet or enhance the disease related quality of life of Ethiopian people with podoconiosis when compared to the control group using the current skin care regimen.~Statistical analysis compared the changes in SCH at the mid-point of the outer lower legs by group from baseline after 3 months of interventions."||-0.736|-2.581|<0.001
72579483|NCT02839772|144687779|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.641|STANDARD_ERROR_OF_MEAN|0.473||0.001|TWO_SIDED|95.0|-2.574|-0.708|||Mixed Models Analysis|t=-3.471, df=186.308||"The null hypothesis was that an evidence-based skin care intervention with added glycerine does not improve skin barrier function in the legs/feet or enhance the disease related quality of life of Ethiopian people with podoconiosis when compared to the control group using the current skin care regimen.~Statistical analysis compared the changes in SCH at the base of the outer lower legs by group from baseline after 3 months of interventions."||-0.708|-2.574|0.001
72544808|NCT04147715|144618768|OTHER|The drug interaction was assessed by whether the 90% CIs for the geometric least squares mean ratio of Cmax, AUC0-last, and AUC0-inf of midazolam were completely contained within the range of 0.8000 to 1.2500.|Geometric Least Squares Mean Ratio|0.8542|||||TWO_SIDED|90.0|0.7185|1.0155|||||Ratio = 50 mg S-648414 + Midazolam / Midazolam|The effect of S-648414 on the PK of midazolam (a CYP3A substrate) was assessed using an ANOVA fitted with a linear mixed effect model with ln-transformed AUC0-last as the dependent variable, treatment as a fixed effect, and participant as a random effect. The difference and 90% CI between the ln-transformed AUC0-last of midazolam plus S-648414 and midazolam alone was estimated then back-transformed to obtain the corresponding geometric least squares mean ratios and 90% CIs.||1.0155|0.7185|
72544809|NCT04147715|144618769|OTHER|The drug interaction was assessed by whether the 90% CIs for the geometric least squares mean ratio of Cmax, AUC0-last, and AUC0-inf of midazolam were completely contained within the range of 0.8000 to 1.2500.|Geometric Least Squares Mean Ratio|0.8377|||||TWO_SIDED|90.0|0.6645|1.0561|||||Ratio = 30 mg S-648414 + Midazolam / Midazolam|The effect of S-648414 on the PK of midazolam (a CYP3A substrate) was assessed using an ANOVA fitted with a linear mixed effect model with ln-transformed AUC0-inf as the dependent variable, treatment as a fixed effect, and participant as a random effect. The difference and 90% CI between the ln-transformed AUC0-inf of midazolam plus S-648414 and midazolam alone was estimated then back-transformed to obtain the corresponding geometric least squares mean ratios and 90% CIs.||1.0561|0.6645|
72544810|NCT04147715|144618769|OTHER|The drug interaction was assessed by whether the 90% CIs for the geometric least squares mean ratio of Cmax, AUC0-last, and AUC0-inf of midazolam were completely contained within the range of 0.8000 to 1.2500.|Geometric Least Squares Mean Ratio|0.8529|||||TWO_SIDED|90.0|0.7213|1.0085|||||Ratio = 50 mg S-648414 + Midazolam / Midazolam|The effect of S-648414 on the PK of midazolam (a CYP3A substrate) was assessed using an ANOVA fitted with a linear mixed effect model with ln-transformed AUC0-inf as the dependent variable, treatment as a fixed effect, and participant as a random effect. The difference and 90% CI between the ln-transformed AUC0-inf of midazolam plus S-648414 and midazolam alone was estimated then back-transformed to obtain the corresponding geometric least squares mean ratios and 90% CIs.||1.0085|0.7213|
72544811|NCT03404206|144618783|SUPERIORITY||||||<|0.001|||||||Log Rank|||||||<0.001
72544812|NCT03404206|144618783|SUPERIORITY||||||<|0.001|||||||Log Rank|||||||<0.001
72544813|NCT03404206|144618784|SUPERIORITY||Least squares means|-34.73|||||TWO_SIDED|95.0|-45.67|-23.8|||ANCOVA|||||-23.8|-45.67|
72544814|NCT03404206|144618784|SUPERIORITY||Least squares means|-73.43|||||TWO_SIDED|95.0|-89.01|-57.85|||ANCOVA|||||-57.85|-89.01|
72544815|NCT03404206|144618784|SUPERIORITY||Least squares means|-38.7|||||TWO_SIDED|95.0|-54.29|-23.11|||ANCOVA|||||-23.11|-54.29|
72544816|NCT03404206|144618785|SUPERIORITY||Least squares means|-18.21|||||TWO_SIDED|95.0|-23.52|-12.89|||ANCOVA|||||-12.89|-23.52|
72544817|NCT03404206|144618785|SUPERIORITY||Least squares means|-33.72|||||TWO_SIDED|95.0|-41.29|-26.14|||ANCOVA|||||-26.14|-41.29|
72544818|NCT03404206|144618785|SUPERIORITY||Least squares means|-15.51|||||TWO_SIDED|95.0|-23.09|-7.93|||ANCOVA|||||-7.93|-23.09|
72544819|NCT02629965|144618807|SUPERIORITY||Mean Difference (Final Values)|0.115|STANDARD_ERROR_OF_MEAN|0.019|<|0.001|TWO_SIDED|95.0|0.077|0.153|||Mixed Models Analysis|Mixed Effect Model Repeated Measures includes treatment and period as fixed effects, study baseline as a covariate and patient as a random effect.|Adjusted mean of differences between treatments and standard error||Mixed effect repeated measurement was used to calculate adjusted mean values as well as treatment contrasts together with the 95% confidence intervals (CIs) and p-values.|0.153|0.077|<0.001
72544820|NCT02629965|144618808|SUPERIORITY||Mean Difference (Final Values)|4.168|STANDARD_ERROR_OF_MEAN|5.26||0.4291|TWO_SIDED|95.0|-6.211|14.548|||Mixed Models Analysis|Mixed Effect Model Repeated Measures includes treatment and period as fixed effects, study baseline as a covariate and patient as a random effect.|Adjusted mean of differences between treatments and standard error||Mixed effect repeated measurement was used to calculate adjusted mean values as well as treatment contrasts together with the 95% confidence intervals (CIs) and p-values.|14.548|-6.211|0.4291
72544821|NCT02629965|144618809|SUPERIORITY||Mean Difference (Final Values)|9.501|STANDARD_ERROR_OF_MEAN|83.704||0.9098|TWO_SIDED|95.0|-155.692|174.694|||Mixed Models Analysis|Mixed Effect Model Repeated Measures includes treatment and period as fixed effects, study baseline as a covariate and patient as a random effect.|Adjusted mean of differences between treatments and standard error||Mixed effect repeated measurement was used to calculate adjusted mean values as well as treatment contrasts together with the 95% confidence intervals (CIs) and p-values.|174.694|-155.692|0.9098
72544822|NCT02629965|144618810|SUPERIORITY||Mean Difference (Final Values)|-0.292|STANDARD_ERROR_OF_MEAN|0.469||0.5338|TWO_SIDED|95.0|-1.217|0.633|||Mixed Models Analysis|Mixed Effect Model Repeated Measures includes treatment and period as fixed effects, study baseline as a covariate and patient as a random effect.|Adjusted mean of differences between treatments and standard error||Mixed effect repeated measurement was used to calculate adjusted mean values as well as treatment contrasts together with the 95% confidence intervals (CIs) and p-values.|0.633|-1.217|0.5338
72544823|NCT02629965|144618811|SUPERIORITY||Mean Difference (Final Values)|0.939|STANDARD_ERROR_OF_MEAN|1.007||0.3524|TWO_SIDED|95.0|-1.048|2.926|||Mixed Models Analysis|Mixed Effect Model Repeated Measures includes treatment and period as fixed effects, study baseline as a covariate and patient as a random effect.|Adjusted mean of differences between treatments and standard error||Mixed effect repeated measurement was used to calculate adjusted mean values as well as treatment contrasts together with the 95% confidence intervals (CIs) and p-values.|2.926|-1.048|0.3524
72544824|NCT02629965|144618812|SUPERIORITY||Mean Difference (Final Values)|2.257|STANDARD_ERROR_OF_MEAN|2.647||0.3949|TWO_SIDED|95.0|-2.966|7.481|||Mixed Models Analysis|Mixed Effect Model Repeated Measures includes treatment and period as fixed effects, study baseline as a covariate and patient as a random effect.|Adjusted mean of differences between treatments and standard error||Mixed effect repeated measurement was used to calculate adjusted mean values as well as treatment contrasts together with the 95% confidence intervals (CIs) and p-values.|7.481|-2.966|0.3949
72579484|NCT02839772|144687780|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.041|STANDARD_ERROR_OF_MEAN|0.572|<|0.001|TWO_SIDED|95.0|-3.168|-0.911|||Mixed Models Analysis|t=-3.565, df=186.739||"The null hypothesis was that an evidence-based skin care intervention with added glycerine does not improve skin barrier function in the legs/feet or enhance the disease related quality of life of Ethiopian people with podoconiosis when compared to the control group using the current skin care regimen.~Statistical analysis compared the changes in SCH at the base of the top of the feet by group from baseline after 3 months of interventions."||-0.911|-3.168|<0.001
72579485|NCT02839772|144687781|SUPERIORITY_OR_OTHER||Odds Ratio, log|0.452|STANDARD_ERROR_OF_MEAN|0.255||0.076|TWO_SIDED|95.0|-0.048|0.952||A cumulative logistic link function was used|Generalized estimating equation analysis|Wald Chi squared=3.138, df=1||"The null hypothesis was that an evidence-based skin care intervention with added glycerine does not improve skin barrier function in the legs/feet or enhance the disease related quality of life of Ethiopian people with podoconiosis when compared to the control group using the current skin care regimen.~Statistical analysis calculated the odds of the stage of podoconiosis by group being more severe at the 4th visit."||0.952|-0.048|0.076
72544825|NCT02629965|144618813|SUPERIORITY||Mean Difference (Final Values)|2.42|STANDARD_ERROR_OF_MEAN|3.543||0.4955|TWO_SIDED|95.0|-4.572|9.411|||Mixed Models Analysis|Mixed Effect Model Repeated Measures includes treatment and period as fixed effects, study baseline as a covariate and patient as a random effect.|Adjusted mean of differences between treatments and standard error||Mixed effect repeated measurement was used to calculate adjusted mean values as well as treatment contrasts together with the 95% confidence intervals (CIs) and p-values.|9.411|-4.572|0.4955
72544826|NCT02629965|144618814|SUPERIORITY||Mean Difference (Final Values)|0.134|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001|TWO_SIDED|95.0|0.091|0.176|||Mixed Models Analysis|Mixed Effect Model Repeated Measures includes treatment and period as fixed effects, study baseline as a covariate and patient as a random effect.|Adjusted mean of differences between treatments and standard error||Mixed effect repeated measurement was used to calculate adjusted mean values as well as treatment contrasts together with the 95% confidence intervals (CIs) and p-values.|0.176|0.091|<0.0001
72579486|NCT02839772|144687782|SUPERIORITY_OR_OTHER||Odds Ratio, log|-0.224||||0.527|TWO_SIDED|95.0|-0.469|0.917||A Bernouilli distribution with a logistic link function was used.|Generalized estimating equation analysis|Wald chi-square=0.410, df=1||"The null hypothesis was that an evidence-based skin care intervention with added glycerine does not improve skin barrier function in the legs/feet or enhance the disease related quality of life of Ethiopian people with podoconiosis when compared to the control group using the current skin care regimen.~Statistical analysis calculated the odds of mossy changes being present in the lower legs/feet by group at the 4th visit."||0.917|-0.469|0.527
72579487|NCT02839772|144687783|SUPERIORITY_OR_OTHER||Odds Ratio, log|-1.29|STANDARD_ERROR_OF_MEAN|0.446||0.031|TWO_SIDED|95.0|-2.161|-0.411||A Bernouilli distribution with a logistic link function was used|Generalized estimating equation analysis|Wald chi-square=8.304, df=1||"The null hypothesis was that an evidence-based skin care intervention with added glycerine does not improve skin barrier function in the legs/feet or enhance the disease related quality of life of Ethiopian people with podoconiosis when compared to the control group using the current skin care regimen.~Statistical analysis calculated the odds of participants having a bad odour emanating from their lower legs/feet by group at the 4th visit. Bad odour results in a decease in quality of life."||-0.411|-2.161|0.031
72579488|NCT02839772|144687784|SUPERIORITY_OR_OTHER||Odds Ratio, log|2.062|STANDARD_ERROR_OF_MEAN|0.741||0.005|TWO_SIDED|95.0|0.61|3.514||A Poisson distribution with a logarithmic link function was used|Generalized estimating equation analysis|Wald chi-square=7.745, df=1||"The null hypothesis was that an evidence-based skin care intervention with added glycerine does not improve skin barrier function in the legs/feet or enhance the disease related quality of life of Ethiopian people with podoconiosis when compared to the control group using the current skin care regimen.~Statistical analysis calculated the odds of wounds being present on the lower legs/feet of participants by group at the 4th visit."||3.514|0.610|0.005
72579489|NCT02839772|144687785|SUPERIORITY_OR_OTHER||Group ratio estimate|2.09|STANDARD_ERROR_OF_MEAN|1.102||0.058|TWO_SIDED|0.058|-0.069|4.25||A Poisson distribution with a logarithmic link function was used.|Generalized estimation equation|df=1|Those in the experimental group were expected to have fewer work days lost due to ADL.|"The null hypothesis was that an evidence-based skin care intervention with added glycerine does not improve skin barrier function in the legs/feet or enhance the disease related quality of life of Ethiopian people with podoconiosis when compared to the control group using the current skin care regimen.~Statistical analysis calculated the odds by group of having had fewer work days lost in the previous month at the 4th visit due to ADL."||4.250|-0.069|0.058
72544827|NCT02629965|144618815|SUPERIORITY||Mean Difference (Final Values)|0.105|STANDARD_ERROR_OF_MEAN|0.009|<|0.0001|TWO_SIDED|95.0|0.088|0.123|||Mixed Models Analysis|Mixed Effect Model Repeated Measures includes treatment and period as fixed effects, study baseline as a covariate and patient as a random effect.|Adjusted mean of differences between treatments and standard error||Mixed effect repeated measurement was used to calculate adjusted mean values as well as treatment contrasts together with the 95% confidence intervals (CIs) and p-values.|0.123|0.088|<0.0001
72544828|NCT02629965|144618816|SUPERIORITY||Mean Difference (Final Values)|0.163|STANDARD_ERROR_OF_MEAN|0.017|<|0.0001|TWO_SIDED|95.0|0.13|0.197|||Mixed Models Analysis|Mixed Effect Model Repeated Measures includes treatment and period as fixed effects, study baseline as a covariate and patient as a random effect.|Adjusted mean of differences between treatments and standard error||Mixed effect repeated measurement was used to calculate adjusted mean values as well as treatment contrasts together with the 95% confidence intervals (CIs) and p-values.|0.197|0.130|<0.0001
72544829|NCT02629965|144618817|SUPERIORITY||Mean Difference (Final Values)|0.133|STANDARD_ERROR_OF_MEAN|0.015|<|0.0001|TWO_SIDED|95.0|0.103|0.162|||Mixed Models Analysis|Mixed Effect Model Repeated Measures includes treatment and period as fixed effects, study baseline as a covariate and patient as a random effect.|Adjusted mean of differences between treatments and standard error||Mixed effect repeated measurement was used to calculate adjusted mean values as well as treatment contrasts together with the 95% confidence intervals (CIs) and p-values.|0.162|0.103|<0.0001
72544830|NCT02629965|144618818|SUPERIORITY||Mean Difference (Final Values)|0.128|STANDARD_ERROR_OF_MEAN|0.014|<|0.0001|TWO_SIDED|95.0|0.1|0.156|||Mixed Models Analysis|Mixed Effect Model Repeated Measures includes treatment and period as fixed effects, study baseline as a covariate and patient as a random effect.|Adjusted mean of differences between treatments and standard error||Mixed effect repeated measurement was used to calculate adjusted mean values as well as treatment contrasts together with the 95% confidence intervals (CIs) and p-values.|0.156|0.100|<0.0001
72579490|NCT02839772|144687786|SUPERIORITY_OR_OTHER||||||<|0.001||||||The p value was \< 0.001 at all time points.|Spearman's correlation coefficient|The correlation at the 1st visit was 0.252, at the 2nd 0.306, at the 3rd 0.291 and at the 4th 0.265.||The null hypothesis was that an evidence-based skin care intervention with added glycerine does not improve skin barrier function in the legs/feet or enhance the disease related quality of life of Ethiopian people with podoconiosis when compared to the control group using the current skin care regimen.||||<0.001
72579491|NCT02839772|144687787|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.288|STANDARD_ERROR_OF_MEAN|0.204||0.158|TWO_SIDED|95.0|-0.113|0.69|||Mixed Models Analysis|df=185.386||"The null hypothesis was that an evidence-based skin care intervention with added glycerine does not improve skin barrier function in the legs/feet or enhance the disease related quality of life of Ethiopian people with podoconiosis when compared to the control group using the current skin care regimen.~A reduction in leg circumference indicates an improvement in the disease."||0.690|-0.113|0.158
72579492|NCT02839772|144687788|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.575|STANDARD_ERROR_OF_MEAN|0.162|<|0.001|TWO_SIDED|95.0|0.255|0.895|||Mixed Models Analysis|df=169.916, t=3.550||"The null hypothesis was that an evidence-based skin care intervention with added glycerine does not improve skin barrier function in the legs/feet or enhance the disease related quality of life of Ethiopian people with podoconiosis when compared to the control group using the current skin care regimen.~A reduction in foot circumference indicates an improvement in the disease."||0.895|0.255|<0.001
72579493|NCT02839772|144687789|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.063|STANDARD_ERROR_OF_MEAN|0.54||0.907|TWO_SIDED|95.0|-1.129|1.002|||Mixed Models Analysis|t=-0.117, df=178.814||"The null hypothesis was that an evidence-based skin care intervention with added glycerine does not improve skin barrier function in the legs/feet or enhance the disease related quality of life of Ethiopian people with podoconiosis when compared to the control group using the current skin care regimen.~Podoconiosis has a large effect on a person's quality of life. abnormal looking legs/feet, wounds and the related bad odour plus social isolation result in stigma and social isolation.."||1.002|-1.129|0.907
72579494|NCT01895777|144687795|NON_INFERIORITY|Non-inferiority margin of 20%|Difference in Rates|-0.038|||=|0.0001|TWO_SIDED|90.0|-0.141|0.066||p-value for non-inferiority is actually \<0.0001|Cochran-Mantel-Haenszel||Difference in rates (SOC - DE)|The primary analysis of the primary efficacy endpoint used the randomised set, following the intention-to-treat principle, based on adjudication-confirmed data. Age group was used as stratification factor using a Mantel-Haenszel type weighted average of differences.||0.066|-0.141|= 0.0001
72579495|NCT01895777|144687796|OTHER||Kaplan-Meier estimate|0.0|||||TWO_SIDED|90.0|-0.032|0.032|||Kaplan-Meier estimate||Kaplan-Meier estimate of rate difference.|Time-to event endpoint using Kaplan-Meier estimates based on adjudication-confirmed data. Due to the low event rate of major bleeding, age group stratification was not considered.||0.032|-0.032|
72579496|NCT01895777|144687802|OTHER||Hazard Ratio (HR)|1.145|||||TWO_SIDED|90.0|0.736|1.78||||||Any bleeding events was analysed as time-to-event endpoint using a stratified Cox proportional hazard model with treatment as a covariate in the model and age group as the stratification factor. A pooling of age groups was performed as no events were observed in certain age group.||1.780|0.736|
72579497|NCT01895777|144687803|OTHER||Hazard Ratio (HR)|69990000.0||||0.9976|TWO_SIDED|90.0|0.0|999999999.0|||Cox proportional hazard model||Upper Limit of the 90% confidence interval was not assessable|All-cause mortality was analyzed as time-to-event endpoint using a stratified Cox proportional hazard model with treatment as a covariate in the model.||999999999|0.000|0.9976
72579498|NCT03735121|144687811|NON_INFERIORITY|The null hypothesis that atezolizumab SC is inferior to atezolizumab IV is rejected if the lower bound of the 2-sided 90% confidence interval \[CI\] of the geometric mean ratio is greater than or equal to (≥) the non-inferiority margin 0.8.|Geometric mean ratio|1.05|||||TWO_SIDED|90.0|0.88|1.24||||||||1.24|0.88|
72579499|NCT03735121|144687812|NON_INFERIORITY|The null hypothesis that atezolizumab SC is inferior to atezolizumab IV is rejected if the lower bound of the 2-sided 90% CI of the geometric mean ratio is ≥ the non-inferiority margin 0.8.|Geometric mean ratio|0.87|||||TWO_SIDED|90.0|0.83|0.92||||||||0.92|0.83|
72579500|NCT01277211|144687852|SUPERIORITY_OR_OTHER_LEGACY||Ratio of Pearl Indices|0.61||||0.531|TWO_SIDED|95.0|0.19|2.29|||Poisson distribution method|Differences between treatment groups was explored using an exact 95% CI for the ratio of the two Pearl Indices based on the Poisson distribution.||Differences between the two treatment groups (ENG-EE vs. DRSP-EE) were explored using an exact 95% CI for the Ratio of the two Pearl Indices based on the Poisson distribution.||2.29|0.19|0.531
72544831|NCT02629965|144618819|SUPERIORITY||Mean Difference (Final Values)|0.082|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|0.056|0.108|||Mixed Models Analysis|Mixed Effect Model Repeated Measures includes treatment and period as fixed effects, study baseline as a covariate and patient as a random effect.|Adjusted mean of differences between treatments and standard error||Mixed effect repeated measurement was used to calculate adjusted mean values as well as treatment contrasts together with the 95% confidence intervals (CIs) and p-values.|0.108|0.056|<0.0001
72544832|NCT02629965|144618820|SUPERIORITY||Mean Difference (Final Values)|0.086|STANDARD_ERROR_OF_MEAN|0.014|<|0.0001|TWO_SIDED|95.0|0.058|0.114|||Mixed Models Analysis|Mixed Effect Model Repeated Measures includes treatment and period as fixed effects, study baseline as a covariate and patient as a random effect.|Adjusted mean of differences between treatments and standard error||Mixed effect repeated measurement was used to calculate adjusted mean values as well as treatment contrasts together with the 95% confidence intervals (CIs) and p-values.|0.114|0.058|<0.0001
72544833|NCT02629965|144618821|SUPERIORITY||Mean Difference (Final Values)|0.083|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|0.059|0.108|||Mixed Models Analysis|Mixed Effect Model Repeated Measures includes treatment and period as fixed effects, study baseline as a covariate and patient as a random effect.|Adjusted mean of differences between treatments and standard error||Mixed effect repeated measurement was used to calculate adjusted mean values as well as treatment contrasts together with the 95% confidence intervals (CIs) and p-values.|0.108|0.059|<0.0001
72544834|NCT02629965|144618822|SUPERIORITY||Mean Difference (Final Values)|0.152|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001|TWO_SIDED|95.0|0.114|0.189|||Mixed Models Analysis|Mixed Effect Model Repeated Measures includes treatment and period as fixed effects, study baseline as a covariate and patient as a random effect.|Adjusted mean of differences between treatments and standard error||Mixed effect repeated measurement was used to calculate adjusted mean values as well as treatment contrasts together with the 95% confidence intervals (CIs) and p-values.|0.189|0.114|<0.0001
72579501|NCT01277211|144687853|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentages, Cycle 1|-3.0||||0.346|TWO_SIDED|95.0|-9.9|3.1|||Miettinen and Nurminen method|||For Cycle 1, a two-sided 95% CI for the difference in percentage between the treatment groups (ENG-EE vs. DRSP-EE) was calculated using the method of Miettinen and Nurminen.||3.1|-9.9|0.346
72579502|NCT01277211|144687853|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentages, Cycle 2|-6.2||||0.029|TWO_SIDED|95.0|-12.7|-0.6|||Miettinen and Nurminen method|||For Cycle 2, a two-sided 95% CI for the difference in percentage between the treatment groups (ENG-EE vs. DRSP-EE) was calculated using the method of Miettinen and Nurminen.||-0.6|-12.7|0.029
72579503|NCT01277211|144687853|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentages, Cycle 3|-5.8||||0.019|TWO_SIDED|95.0|-11.8|-0.9|||Miettinen and Nurminen method|||For Cycle 3, a two-sided 95% CI for the difference in percentage between the treatment groups (ENG-EE vs. DRSP-EE) was calculated using the method of Miettinen and Nurminen.||-0.9|-11.8|0.019
72579504|NCT01277211|144687853|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentages, Cycle 4|-8.0||||0.001|TWO_SIDED|95.0|-14.0|-2.9|||Miettinen and Nurminen method|||For Cycle 4, a two-sided 95% CI for the difference in percentage between the treatment groups (ENG-EE vs. DRSP-EE) was calculated using the method of Miettinen and Nurminen.||-2.9|-14.0|0.001
72579505|NCT01277211|144687853|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentages, Cycle 5|-1.3||||0.556|TWO_SIDED|95.0|-6.4|2.6|||Miettinen and Nurminen method|||For Cycle 5, a two-sided 95% CI for the difference in percentage between the treatment groups (ENG-EE vs. DRSP-EE) was calculated using the method of Miettinen and Nurminen.||2.6|-6.4|0.556
72579506|NCT01277211|144687853|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentages, Cycle 6|-3.9||||0.089|TWO_SIDED|95.0|-9.5|0.5|||Miettinen and Nurminen method|||For Cycle 6, a two-sided 95% CI for the difference in percentage between the treatment groups (ENG-EE vs. DRSP-EE) was calculated using the method of Miettinen and Nurminen.||0.5|-9.5|0.089
72579507|NCT01277211|144687853|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentages, Cycle 7|-3.7||||0.11|TWO_SIDED|95.0|-9.4|0.8|||Miettinen and Nurminen method|||For Cycle 7, a two-sided 95% CI for the difference in percentage between the treatment groups (ENG-EE vs. DRSP-EE) was calculated using the method of Miettinen and Nurminen.||0.8|-9.4|0.110
72579508|NCT01277211|144687853|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentages, Cycle 8|-4.3||||0.049|TWO_SIDED|95.0|-9.8|0.0|||Miettinen and Nurminen method|||For Cycle 8, a two-sided 95% CI for the difference in percentage between the treatment groups (ENG-EE vs. DRSP-EE) was calculated using the method of Miettinen and Nurminen.||-0.0|-9.8|0.049
72579509|NCT01277211|144687853|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentages, Cycle 9|-1.1||||0.621|TWO_SIDED|95.0|-6.2|2.9|||Miettinen and Nurminen method|||For Cycle 9, a two-sided 95% CI for the difference in percentage between the treatment groups (ENG-EE vs. DRSP-EE) was calculated using the method of Miettinen and Nurminen.||2.9|-6.2|0.621
72579510|NCT01277211|144687853|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentages, Cycle 10|-4.4||||0.041|TWO_SIDED|95.0|-10.0|-0.2|||Miettinen and Nurminen method|||For Cycle 10, a two-sided 95% CI for the difference in percentage between the treatment groups (ENG-EE vs. DRSP-EE) was calculated using the method of Miettinen and Nurminen.||-0.2|-10.0|0.041
72579511|NCT01277211|144687853|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentages, Cycle 11|-3.8||||0.046|TWO_SIDED|95.0|-8.9|-0.1|||Miettinen and Nurminen method|||For Cycle 11, a two-sided 95% CI for the difference in percentage between the treatment groups (ENG-EE vs. DRSP-EE) was calculated using the method of Miettinen and Nurminen.||-0.1|-8.9|0.046
72579512|NCT01277211|144687853|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentages, Cycle 12|-4.4||||0.037|TWO_SIDED|95.0|-9.9|-0.2|||Miettinen and Nurminen method|||For Cycle 12, a two-sided 95% CI for the difference in percentage between the treatment groups (ENG-EE vs. DRSP-EE) was calculated using the method of Miettinen and Nurminen.||-0.2|-9.9|0.037
72544835|NCT02330081|144618823|NON_INFERIORITY|The FDA validation level requirements for test platelet quality is that the lower 1-sided 95% confidence limit of platelet recovery must be ≥ 66% of fresh control platelet values|Risk Ratio (RR)|83.3|STANDARD_ERROR_OF_MEAN|4.97|||ONE_SIDED|95.0|76.2||||||Estimate is the ratio of the mean platelet recovery of treatment over control||||76.2|
72544836|NCT02330081|144618824|NON_INFERIORITY|One of the FDA validation level requirements for test platelet quality is that the lower 1-sided 95% confidence limit of the mean platelet survival time must be ≥58% of fresh control platelet mean survival time|Mean Ratio Survival Time|81.0|STANDARD_ERROR_OF_MEAN|2.0|||ONE_SIDED|95.0|77.0||||||Estimate is the ratio of the mean platelet survival time of treatment over control||||77.0|
72544837|NCT00905489|144618842|SUPERIORITY_OR_OTHER||Ratio NVP XR: NVP IR (%)|91.2|STANDARD_ERROR_OF_MEAN|1.05||0.008|TWO_SIDED|90.0|83.47|99.64|||Mixed Models Analysis|Adjusted geometric means are estimated from the mixed model for intra-individual comparison.||||99.64|83.47|0.0080
72544838|NCT02668302|144618869|SUPERIORITY|||||||0.4709|||||||t-test, 2 sided|P-values from two-sample T-test with equal variance assumption||||||0.4709
72544839|NCT00895583|144618878|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.7||||0.239|TWO_SIDED|95.0|0.4|1.3||Two-sided alpha equals (=) 0.05.|Fisher Exact|||||1.3|0.4|0.239
72544840|NCT00895583|144618879|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.8||||0.422|TWO_SIDED|95.0|0.5|1.4||Alpha was unadjusted.|Fisher Exact|||||1.4|0.5|0.422
72544841|NCT00895583|144618880|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.8||||0.524|TWO_SIDED|95.0|0.5|1.4||Alpha was unadjusted.|Fisher Exact|||Month 12||1.4|0.5|0.524
72544842|NCT00895583|144618880|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.7||||0.298|TWO_SIDED|95.0|0.4|1.2||Alpha was unadjusted.|Fisher Exact|||Month 24||1.2|0.4|0.298
72544843|NCT00895583|144618881|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.6||||0.055|TWO_SIDED|95.0|0.3|1.0||Alpha was unadjusted.|Fisher Exact|||Month 12||1.0|0.3|0.055
72544844|NCT00895583|144618881|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.8||||0.33|TWO_SIDED|95.0|0.4|1.3||Alpha was unadjusted.|Fisher Exact|||Month 24||1.3|0.4|0.330
72544845|NCT00895583|144618882|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.8||||0.543|TWO_SIDED|95.0|0.4|1.5||Alpha was unadjusted.|Fisher Exact|||Month 12||1.5|0.4|0.543
72544846|NCT00895583|144618882|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.0||||1|TWO_SIDED|95.0|0.6|1.8||Alpha was unadjusted.|Fisher Exact|||Month 24||1.8|0.6|1.000
72544847|NCT00895583|144618884|SUPERIORITY_OR_OTHER||Least Squares (LS) Mean Difference|3.0|STANDARD_ERROR_OF_MEAN|1.3||0.019|TWO_SIDED|95.0|0.5|5.5||Alpha was unadjusted.|ANCOVA|Analysis of covariance (ANCOVA) with treatment as a factor and baseline GFR as a covariate.||Change from randomization at Month 6||5.5|0.5|0.019
72544848|NCT00895583|144618884|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.9|STANDARD_ERROR_OF_MEAN|1.5||0.215|TWO_SIDED|95.0|-4.8|1.1||Alpha was unadjusted.|ANCOVA|ANCOVA with treatment as a factor and baseline GFR as a covariate.||Change from randomization at Month 12||1.1|-4.8|0.215
72544849|NCT00895583|144618884|SUPERIORITY_OR_OTHER||LS Mean Difference|0.6|STANDARD_ERROR_OF_MEAN|1.7||0.722|TWO_SIDED|95.0|-2.7|3.9||Alpha was unadjusted.|ANCOVA|ANCOVA with treatment as a factor and baseline GFR as a covariate.||Change from randomization at Month 18||3.9|-2.7|0.722
72544850|NCT00895583|144618884|SUPERIORITY_OR_OTHER||LS Mean Difference|0.7|STANDARD_ERROR_OF_MEAN|1.9||0.71|TWO_SIDED|95.0|-3.0|4.4||Alpha was unadjusted.|ANCOVA|ANCOVA with treatment as a factor and baseline GFR as a covariate.||Change from randomization at Month 24||4.4|-3.0|0.710
72579513|NCT01277211|144687853|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentages, Cycle 13|-4.5||||0.048|TWO_SIDED|95.0|-10.4|0.0|||Miettinen and Nurminen method|||For Cycle 13, a two-sided 95% CI for the difference in percentage between the treatment groups (ENG-EE vs. DRSP-EE) was calculated using the method of Miettinen and Nurminen.||-0.0|-10.4|0.048
72544851|NCT00895583|144618885|SUPERIORITY_OR_OTHER||Slope difference (SRL-TAC)|-1.8||||0.131|TWO_SIDED|95.0|-4.2|0.5|||Random coefficient model||Random coefficient model with GFR as the dependent variable and study day as the independent variable.|Slope difference (sirolimus \[SRL\] minus tacrolimus \[TAC\])||0.5|-4.2|0.131
72544852|NCT00895583|144618887|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.9|STANDARD_ERROR_OF_MEAN|2.4||0.105|TWO_SIDED|95.0|-8.6|0.8||Alpha was unadjusted.|ANCOVA|ANCOVA with treatment as a factor and baseline serum creatinine as a covariate.||Change from randomization at Month 6||0.8|-8.6|0.105
72544853|NCT00895583|144618887|SUPERIORITY_OR_OTHER||LS Mean Difference|7.7|STANDARD_ERROR_OF_MEAN|3.3||0.023|TWO_SIDED|95.0|1.1|14.3||Alpha was unadjusted.|ANCOVA|ANCOVA with treatment as a factor and baseline serum creatinine as a covariate.||Change from randomization at Month 12||14.3|1.1|0.023
72544854|NCT00895583|144618887|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|3.4||0.955|TWO_SIDED|95.0|-6.8|6.4||Alpha was unadjusted.|ANCOVA|ANCOVA with treatment as a factor and baseline serum creatinine as a covariate.||Change from randomization at Month 18||6.4|-6.8|0.955
72544855|NCT00895583|144618887|SUPERIORITY_OR_OTHER||LS Mean Difference|3.2|STANDARD_ERROR_OF_MEAN|5.8||0.582|TWO_SIDED|95.0|-8.2|14.6||Alpha was unadjusted.|ANCOVA|ANCOVA with treatment as a factor and baseline serum creatinine as a covariate.||Change from randomization at Month 24||14.6|-8.2|0.582
72544856|NCT00895583|144618888|SUPERIORITY_OR_OTHER|||||||0.006|TWO_SIDED|||||Alpha was unadjusted.|Fisher Exact|||||||0.006
72544857|NCT00895583|144618889|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED|||||Alpha was unadjusted.|Fisher Exact|||Post-randomization to Month 12 Post-transplantation||||1.000
72544858|NCT00895583|144618889|SUPERIORITY_OR_OTHER|||||||0.215|TWO_SIDED|||||Alpha was unadjusted.|Fisher Exact|||Post-randomization to Month 24 post-transplantation||||0.215
72544859|NCT00895583|144618890|SUPERIORITY_OR_OTHER|||||||0.499|TWO_SIDED|||||Alpha was unadjusted.|Fisher Exact|||Month 6||||0.499
72544860|NCT00895583|144618890|SUPERIORITY_OR_OTHER|||||||0.067|TWO_SIDED|||||Alpha was unadjusted.|Fisher Exact|||Month 12||||0.067
72544861|NCT00895583|144618890|SUPERIORITY_OR_OTHER|||||||0.061|TWO_SIDED|||||Alpha was unadjusted.|Fisher Exact|||Month 18||||0.061
72544862|NCT00895583|144618890|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED|||||Alpha was unadjusted.|Fisher Exact|||Month 24||||0.020
72579514|NCT01277211|144687854|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentages, Cycle 1|-6.0||||0.015|TWO_SIDED|95.0|-12.0|-1.1|||Miettinen and Nurminen method|||For Cycle 1, a two-sided 95% CI for the difference in percentage between the treatment groups (ENG-EE vs. DRSP-EE) was calculated using the method of Miettinen and Nurminen.||-1.1|-12.0|0.015
72579515|NCT01277211|144687854|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentages, Cycle 2|-4.9||||0.012|TWO_SIDED|95.0|-10.1|-1.0|||Miettinen and Nurminen method|||For Cycle 2, a two-sided 95% CI for the difference in percentage between the treatment groups (ENG-EE vs. DRSP-EE) was calculated using the method of Miettinen and Nurminen.||-1.0|-10.1|0.012
72544863|NCT00895583|144618893|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED|||||Alpha was unadjusted.|Fisher Exact|||On-therapy Period||||1.000
72579516|NCT01277211|144687854|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentages, Cycle 3|-6.5||||0.002|TWO_SIDED|95.0|-12.0|-2.2|||Miettinen and Nurminen method|||For Cycle 3, a two-sided 95% CI for the difference in percentage between the treatment groups (ENG-EE vs. DRSP-EE) was calculated using the method of Miettinen and Nurminen.||-2.2|-12.0|0.002
72579517|NCT01277211|144687854|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentages, Cycle 4|-3.6||||0.044|TWO_SIDED|95.0|-8.5|-0.1|||Miettinen and Nurminen method|||For Cycle 4, a two-sided 95% CI for the difference in percentage between the treatment groups (ENG-EE vs. DRSP-EE) was calculated using the method of Miettinen and Nurminen.||-0.1|-8.5|0.044
72544864|NCT00895583|144618893|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED|||||Alpha was unadjusted.|Fisher Exact|||Off-therapy Period||||1.000
72544865|NCT00895583|144618894|SUPERIORITY_OR_OTHER|||||||0.284|TWO_SIDED|||||Alpha was unadjusted.|Fisher Exact|||Baseline||||0.284
72544866|NCT00895583|144618894|SUPERIORITY_OR_OTHER|||||||0.046|TWO_SIDED|||||Alpha was unadjusted.|Fisher Exact|||Month 12||||0.046
72544867|NCT00895583|144618894|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED|||||Alpha was unadjusted.|Fisher Exact|||Month 24||||1.000
72544868|NCT00895583|144618895|SUPERIORITY_OR_OTHER||Difference in Adjusted Means|0.81|STANDARD_ERROR_OF_MEAN|0.12|<|0.001|TWO_SIDED|||||Alpha was unadjusted.|ANCOVA|ANCOVA with treatment as a factor and baseline as a covariate.||TC, Month 12||||<0.001
72544869|NCT00895583|144618895|SUPERIORITY_OR_OTHER||Difference in Adjusted Mean|0.61|STANDARD_ERROR_OF_MEAN|0.14|<|0.001|TWO_SIDED|||||Alpha was unadjusted.|ANCOVA|ANCOVA with treatment as a factor and baseline as a covariate.||TC, Month 24||||<0.001
72579518|NCT01277211|144687854|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentages, Cycle 5|-1.0||||0.609|TWO_SIDED|95.0|-5.7|2.5|||Miettinen and Nurminen method|||For Cycle 5, a two-sided 95% CI for the difference in percentage between the treatment groups (ENG-EE vs. DRSP-EE) was calculated using the method of Miettinen and Nurminen.||2.5|-5.7|0.609
72579519|NCT01277211|144687854|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentages, Cycle 6|-3.9||||0.062|TWO_SIDED|95.0|-9.3|0.2|||Miettinen and Nurminen method|||For Cycle 6, a two-sided 95% CI for the difference in percentage between the treatment groups (ENG-EE vs. DRSP-EE) was calculated using the method of Miettinen and Nurminen.||0.2|-9.3|0.062
72579520|NCT01277211|144687854|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentages, Cycle 7|-4.1||||0.019|TWO_SIDED|95.0|-9.0|-0.6|||Miettinen and Nurminen method|||For Cycle 7, a two-sided 95% CI for the difference in percentage between the treatment groups (ENG-EE vs. DRSP-EE) was calculated using the method of Miettinen and Nurminen.||-0.6|-9.0|0.019
72544870|NCT00895583|144618895|SUPERIORITY_OR_OTHER||Difference in Adjusted Means|-0.01|STANDARD_ERROR_OF_MEAN|0.03||0.824|TWO_SIDED|||||Alpha was unadjusted.|ANCOVA|ANCOVA with treatment as a factor and baseline as a covariate.||HDL-C, Month 12||||0.824
72544871|NCT00895583|144618895|SUPERIORITY_OR_OTHER||Difference in Adjusted Means|-0.02|STANDARD_ERROR_OF_MEAN|0.05||0.735|TWO_SIDED|||||Alpha was unadjusted.|ANCOVA|ANCOVA with treatment as a factor and baseline as a covariate.||HDL-C, Month 24||||0.735
72544872|NCT00895583|144618895|SUPERIORITY_OR_OTHER||Difference in Adjusted Means|0.49|STANDARD_ERROR_OF_MEAN|0.11|<|0.001|TWO_SIDED|||||Alpha was unadjusted.|ANCOVA|ANCOVA with treatment as a factor and baseline as a covariate.||LDL-C, Month 12||||<0.001
72544873|NCT00895583|144618895|SUPERIORITY_OR_OTHER||Difference in Adjusted Means|0.42|STANDARD_ERROR_OF_MEAN|0.13||0.001|TWO_SIDED|||||Alpha was unadjusted.|ANCOVA|ANCOVA with treatment as a factor and baseline as a covariate.||LDL-C, Month 24||||0.001
72544874|NCT00895583|144618895|SUPERIORITY_OR_OTHER||Difference in Adjusted Means|0.65|STANDARD_ERROR_OF_MEAN|0.13|<|0.001|TWO_SIDED|||||Alpha was unadjusted.|ANCOVA|ANCOVA with treatment as a factor and baseline as a covariate.||Triglycerides, Month 12||||<0.001
72544875|NCT00895583|144618895|SUPERIORITY_OR_OTHER||Difference in Adjusted Means|0.37|STANDARD_ERROR_OF_MEAN|0.16||0.028|TWO_SIDED|||||Alpha was unadjusted.|ANCOVA|ANCOVA with treatment as a factor and baseline as a covariate.||Triglycerides, Month 24||||0.028
72544876|NCT00895583|144618896|SUPERIORITY_OR_OTHER|||||||0.429|TWO_SIDED|||||Alpha was unadjusted.|Fisher Exact|||Anti-hypertensives, Baseline||||0.429
72544877|NCT00895583|144618896|SUPERIORITY_OR_OTHER|||||||0.326|TWO_SIDED|||||Alpha was unadjusted.|Fisher Exact|||Anti-hypertensives, Month 12||||0.326
72544878|NCT00895583|144618896|SUPERIORITY_OR_OTHER|||||||0.517|TWO_SIDED|||||Alpha was unadjusted.|Fisher Exact|||Anti-hypertensives, Month 24||||0.517
72544879|NCT00895583|144618896|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED|||||Alpha was unadjusted.|Fisher Exact|||Diabetes agents (insulin), Baseline||||1.000
72544880|NCT00895583|144618896|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED|||||Alpha was unadjusted.|Fisher Exact|||Diabetes agent (insulin), Month 12||||1.000
72544881|NCT00895583|144618896|SUPERIORITY_OR_OTHER|||||||0.223|TWO_SIDED|||||Alpha was unadjusted.|Fisher Exact|||Diabetes agent (insulin), Month 24||||0.223
72544882|NCT00895583|144618896|SUPERIORITY_OR_OTHER|||||||0.498|TWO_SIDED|||||Alpha was unadjusted.|Fisher Exact|||Diabetes agent (non-insulin), Baseline||||0.498
72544883|NCT00895583|144618896|SUPERIORITY_OR_OTHER|||||||0.566|TWO_SIDED|||||Alpha was unadjusted.|Fisher Exact|||Diabetes agent (non-insulin), Month 12||||0.566
72544884|NCT00895583|144618896|SUPERIORITY_OR_OTHER|||||||0.423|TWO_SIDED|||||Alpha was unadjusted.|Fisher Exact|||Diabetes agent (non-insulin), Month 24||||0.423
72544885|NCT00895583|144618896|SUPERIORITY_OR_OTHER|||||||0.033|TWO_SIDED|||||Alpha was unadjusted.|Fisher Exact|||Lipid-lowering agents, Baseline||||0.033
72544886|NCT00895583|144618896|SUPERIORITY_OR_OTHER|||||||0.9|TWO_SIDED|||||Alpha was unadjusted.|Fisher Exact|||Lipid-lowering agents, Month 12||||0.900
72544887|NCT00895583|144618896|SUPERIORITY_OR_OTHER|||||||0.802|TWO_SIDED|||||Alpha was unadjusted.|Fisher Exact|||Lipid-lowering agents, Month 24||||0.802
72544888|NCT00895583|144618896|SUPERIORITY_OR_OTHER|||||||0.26|TWO_SIDED|||||Alpha was unadjusted.|Fisher Exact|||ESAs, Baseline||||0.260
72544889|NCT00895583|144618896|SUPERIORITY_OR_OTHER|||||||0.086|TWO_SIDED|||||Alpha was unadjusted.|Fisher Exact|||ESAs, Month 12||||0.086
72544890|NCT00895583|144618896|SUPERIORITY_OR_OTHER|||||||0.723|TWO_SIDED|||||Alpha was unadjusted.|Fisher Exact|||ESAs, Month 24||||0.723
72544891|NCT00895583|144618897|SUPERIORITY_OR_OTHER||Treatment Ratio|1.71|||<|0.001|TWO_SIDED|95.0|1.38|2.11||Alpha was unadjusted.|ANCOVA|ANCOVA model with change in the logarithmic Upr/Cr as dependent variable, treatment and logarithmic pre-randomization value as covariate.||Change from pre-randomization at Month 12; treatment ratio (SRC/TAC) in adjusted geometric mean fold-change from baseline.||2.11|1.38|<0.001
72544892|NCT00895583|144618897|SUPERIORITY_OR_OTHER||Treatment Ratio|1.77|||<|0.001|TWO_SIDED|95.0|1.39|2.26||Alpha was unadjusted.|ANCOVA|ANCOVA model with change in the logarithmic Upr/Cr as dependent variable, treatment and logarithmic pre-randomization value as covariate.||Change from pre-randomization at Month 24; treatment ratio (SRC/TAC) in adjusted geometric mean fold-change from baseline.||2.26|1.39|<0.001
72544893|NCT00895583|144618898|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED|||||Alpha was unadjusted.|Fisher Exact|||Pre-randomization||||1.000
72544894|NCT00895583|144618898|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED|||||Alpha was unadjusted.|Fisher Exact|||On-Therapy Period||||0.020
72544895|NCT00895583|144618898|SUPERIORITY_OR_OTHER|||||||0.021|TWO_SIDED|||||Alpha was unadjusted.|Fisher Exact|||Off-Therapy Period||||0.021
72544896|NCT00895583|144618899|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Alpha is unadjusted.|Fisher Exact|||||||<0.001
72544897|NCT00895583|144618900|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Alpha was unadjusted.|Fisher Exact|||On-Therapy Period, any treatment||||<0.001
72579521|NCT01277211|144687854|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentages, Cycle 8|-1.9||||0.308|TWO_SIDED|95.0|-6.7|1.6|||Miettinen and Nurminen method|||For Cycle 8, a two-sided 95% CI for the difference in percentage between the treatment groups (ENG-EE vs. DRSP-EE) was calculated using the method of Miettinen and Nurminen.||1.6|-6.7|0.308
72544898|NCT00895583|144618900|SUPERIORITY_OR_OTHER|||||||0.685|TWO_SIDED|||||Alpha was unadjusted.|Fisher Exact|||Off-Therapy Period, any treatment||||0.685
72544899|NCT00895583|144618901|SUPERIORITY_OR_OTHER||Difference in Adjusted Means|0.0|STANDARD_ERROR_OF_MEAN|0.0||0.521|TWO_SIDED|||||Alpha was unadjusted.|ANCOVA|||||||0.521
72544900|NCT00895583|144618902|SUPERIORITY_OR_OTHER||Difference in Adjusted Means|-0.28|STANDARD_ERROR_OF_MEAN|0.25||0.265|TWO_SIDED|||||Alpha is unadjusted.|ANCOVA||ANCOVA with treatment as a factor and baseline as a covariate.|||||0.265
72544901|NCT00895583|144618903|SUPERIORITY_OR_OTHER||Difference in Adjusted Means|10.02|STANDARD_ERROR_OF_MEAN|23.61||0.672|TWO_SIDED|||||Alpha was unadjusted.|ANCOVA||ANCOVA with treatment as a factor and baseline as a covariate.|||||0.672
72544902|NCT00895583|144618904|SUPERIORITY_OR_OTHER||Difference in Adjusted Means|-0.45|STANDARD_ERROR_OF_MEAN|0.67||0.504|TWO_SIDED|||||Alpha was unadjusted.|ANCOVA||ANCOVA with treatment as a factor and baseline as a covariate.|||||0.504
72544903|NCT00895583|144618905|SUPERIORITY_OR_OTHER||Difference in Adjusted Means|-0.56|STANDARD_ERROR_OF_MEAN|1.18||0.637|TWO_SIDED|||||Alpha was unadjusted.|ANCOVA|ANCOVA with treatment as a factor and baseline as a covariate.||||||0.637
72579522|NCT01277211|144687854|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentages, Cycle 9|-4.2||||0.027|TWO_SIDED|95.0|-9.3|-0.4|||Miettinen and Nurminen method|||For Cycle 9, a two-sided 95% CI for the difference in percentage between the treatment groups (ENG-EE vs. DRSP-EE) was calculated using the method of Miettinen and Nurminen.||-0.4|-9.3|0.027
72544904|NCT00895583|144618906|SUPERIORITY_OR_OTHER||Difference in Adjusted Means|0.08|STANDARD_ERROR_OF_MEAN|1.48||0.955|TWO_SIDED|||||Alpha was unadjusted.|ANCOVA|ANCOVA with treatment as a factor and baseline as a covariate.||||||0.955
72544905|NCT00895583|144618907|SUPERIORITY_OR_OTHER||Difference in Adjusted Means|216.29|STANDARD_ERROR_OF_MEAN|198.84||0.279|TWO_SIDED|||||Alpha was unadjusted.|ANCOVA|ANCOVA with treatment as a factor and baseline as a covariate.||||||0.279
72544906|NCT00895583|144618908|SUPERIORITY_OR_OTHER||Difference in Adjusted Means|-0.22|STANDARD_ERROR_OF_MEAN|0.23||0.337|TWO_SIDED|||||Alpha was unadjusted.|ANCOVA|||||||0.337
72544907|NCT00895583|144618909|SUPERIORITY_OR_OTHER|||||||0.025|TWO_SIDED|||||Alpha was unadjusted.|Fisher Exact|||New onset (from baseline up to On-Therapy Month 24)||||0.025
72544908|NCT00895583|144618909|SUPERIORITY_OR_OTHER|||||||0.012|TWO_SIDED|||||Alpha was unadjusted.|Fisher Exact|||New onset at 1 year (from baseline up to On-Therapy Month 12)||||0.012
72544909|NCT00895583|144618909|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED|||||Alpha was unadjusted.|Fisher Exact|||New onset at 2 years (from On-Therapy Month 12 to On-Therapy Month 24)||||1.000
72544910|NCT00895583|144618910|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED|||||Alpha was unadjusted.|Fisher Exact|||Insulin (12-Month)||||1.000
72544911|NCT00895583|144618910|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED|||||Alpha was unadjusted.|Fisher Exact|||Non-insulin (12-Month)||||1.000
72544912|NCT00895583|144618910|SUPERIORITY_OR_OTHER|||||||0.386|TWO_SIDED|||||Alpha was unadjusted.|Fisher Exact|||Non-insulin (24-Month)||||0.386
72544913|NCT00895583|144618910|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED|||||Alpha was unadjusted.|Fisher Exact|||Insulin (24-Month)||||1.000
72544914|NCT00895583|144618911|SUPERIORITY_OR_OTHER|||||||0.129|TWO_SIDED||||||Fisher Exact|||||||0.129
72544915|NCT00895583|144618912|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Fisher Exact|||||||1.000
72544916|NCT00895583|144618913|SUPERIORITY_OR_OTHER|||||||0.276|TWO_SIDED||||||Fisher Exact|||||||0.276
72544917|NCT00895583|144618914|SUPERIORITY_OR_OTHER|||||||0.158|TWO_SIDED||||||Fisher Exact|||||||0.158
72544918|NCT01710306|144618951|SUPERIORITY|||||||0.1996|||||||Chi-squared|||||||0.1996
72544919|NCT01191255|144618956|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||The P-value for the change in mean serum phosphorus was calculated via an ANCOVA model with treatment as the fixed effect and Week-52-baseline as the co-variate.|ANCOVA|||||||<0.0001
72544920|NCT01191255|144618957|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||The P-value for the change in mean serum Ferritin were created via an ANCOVA model with treatment as the fixed effect and Study-baseline as the co-variate.|ANCOVA|||||||<0.0001
72544921|NCT01191255|144618958|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|||||||<0.0001
72544922|NCT01191255|144618959|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
72544923|NCT01191255|144618960|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<0.05
72544924|NCT02196506|144618961|SUPERIORITY||Mean Difference (Final Values)|-2.3||||0.0074|TWO_SIDED|95.0|-3.97|-0.62|||Mixed Models Analysis|||Statistical Analysis at Week 14||-0.62|-3.97|0.0074
72411437|NCT03207750|144331233|NON_INFERIORITY|Lower limit (LL) of the two-sided asymptotic standardized 95% CI for the difference in seroprotective concentrations (HRV PCV-free Liquid group minus HRV Lyophilized group) for each of anti-PRP antibodies should be ≥-10%.|Difference in anti-PRP concentration|-0.88|||||TWO_SIDED|95.0|-5.75|3.99||||||Non-inferiority of the immune responses to 3 doses of Pediarix, Hiberix and Prevenar 13 when co-administered with 2 doses of the PCV-free liquid HRV vaccine, as compared to when co-administered with lyophilized HRV vaccine in terms of group difference in percentage of subjects with concentrations (≥ 1.0 µg/mL) of anti-PRP antibodies.||3.99|-5.75|
72411438|NCT03207750|144331234|OTHER|p-value on the difference in seroresponse (HRV PCV-free Liquid group minus HRV Lyophilized group) between groups should be \<=0.025 for PT antigen.|||||<|0.0001|||||||t-test, 1 sided|p-value was computed by integrating on p-values of 1 sided test with alpha=0.025 \& the posterior probability of the cut-off in HRV Lyophilized group||To rule out 10% decrease in seroresponse to PT antigen in subjects who received Pediarix co-administered with PCV-free-Liquid-HRV vaccine compared to subjects who received Pediarix co-administered with currently licensed lyophilized HRV vaccine where seroresponse was defined as percentage of subjects who showed a concentration above a threshold that led to 95% seroresponse in HRV lyophilized group.||||<.0001
72411439|NCT03207750|144331234|OTHER|p-value on the difference in seroresponse (HRV PCV-free Liquid group minus HRV Lyophilized group) between groups should be \<=0.025 for FHA antigen.|||||<|0.0001|||||||t-test, 1 sided|p-value was computed by integrating on p-values of 1 sided test with alpha=0.025 \& the posterior probability of the cut-off in HRV lyophilized group||To rule out 10% decrease in seroresponse to FHA antigen in subjects who received Pediarix co-administered with PCV-free-Liquid-HRV vaccine compared to subjects who received Pediarix co-administered with currently licensed lyophilized HRV vaccine where seroresponse was defined as percentage of subjects who showed a concentration above a threshold that led to 95% seroresponse in HRV lyophilized group.||||<.0001
72544925|NCT02196506|144618962|SUPERIORITY||Mean Difference (Final Values)|-0.22||||0.3331|TWO_SIDED|95.0|-0.66|0.23|||Mixed Models Analysis|||Statistical Analysis at Week 14||0.23|-0.66|0.3331
72544926|NCT02196506|144618963|SUPERIORITY||Mean Difference (Final Values)|-2.25||||0.0263|TWO_SIDED|95.0|-4.23|-0.27|||Mixed Models Analysis|||Statistical Analysis at Week 14||-0.27|-4.23|0.0263
72544927|NCT02196506|144618964|SUPERIORITY||Mean Difference (Final Values)|-2.98||||0.0099|TWO_SIDED|95.0|-5.24|-0.72|||Mixed Models Analysis|||Statistical Analysis at Week 14||-0.72|-5.24|0.0099
72544928|NCT01743677|144618981|SUPERIORITY||Least Squares Mean Difference|-1.29|||||TWO_SIDED|90.0|-3.15|0.56||||||||0.56|-3.15|
72544929|NCT01743677|144618982|SUPERIORITY||Least Squares Mean Difference|-1.42|||||TWO_SIDED|90.0|-3.28|0.43||||||||0.43|-3.28|
72544930|NCT01743677|144618983|SUPERIORITY||Least Squares Mean Difference|-2.29|||||TWO_SIDED|90.0|-4.15|-0.44||||||||-0.44|-4.15|
72544931|NCT01743677|144618984|SUPERIORITY||Least Squares Mean Difference|-1.35|||||TWO_SIDED|90.0|-3.21|0.5||||||||0.50|-3.21|
72544932|NCT01743677|144618985|SUPERIORITY||Least Squares Mean Difference|1.08|||||TWO_SIDED|90.0|-0.78|2.93||||||||2.93|-0.78|
72411440|NCT03207750|144331234|OTHER|p-value on the difference in seroresponse (HRV PCV-free Liquid group minus HRV Lyophilized group) between groups should be \<=0.025 for PRN antigen.|||||<|0.0001|||||||t-test, 1 sided|p-value was computed by integrating on p-values of 1 sided test with alpha=0.025 \& the posterior probability of the cut-off in HRV Lyophilized group||To rule out 10% decrease in seroresponse to PRN antigen in subjects who received Pediarix co-administered with PCV-free-Liquid-HRV vaccine compared to subjects who received Pediarix co-administered with currently licensed lyophilized HRV vaccine where seroresponse was defined as percentage of subjects who showed a concentration above a threshold that led to 95% seroresponse in HRV lyophilized group.||||<.0001
72411441|NCT01700946|144331279|SUPERIORITY|||||||0.035|||||||Log Rank|||||||0.035
72411442|NCT01700946|144331280|SUPERIORITY|||||||0.105|||||||Log Rank|||||||0.105
72544933|NCT01743677|144618986|SUPERIORITY||Least Squares Mean Difference|0.86|||||TWO_SIDED|90.0|-1.0|2.71||||||||2.71|-1.00|
72544934|NCT01743677|144618987|SUPERIORITY||Least Squares Mean Difference|1.15|||||TWO_SIDED|90.0|-0.71|3.0||||||||3.00|-0.71|
72544935|NCT01743677|144618988|SUPERIORITY||Least Squares Mean Difference|2.15|||||TWO_SIDED|90.0|0.29|4.0||||||||4.00|0.29|
72544936|NCT01743677|144618989|SUPERIORITY||Least Squares Mean Difference|1.35|||||TWO_SIDED|90.0|-0.5|3.21||||||||3.21|-0.50|
72544937|NCT01743677|144618990|SUPERIORITY||Least Squares Mean Difference|11.29|||||TWO_SIDED|90.0|9.62|12.96||||||||12.96|9.62|
72544938|NCT01743677|144618991|SUPERIORITY||Least Squares Mean Difference|0.16|||||TWO_SIDED|90.0|-2.11|2.44||||||0.25 hour post-dose||2.44|-2.11|
72544939|NCT01743677|144618991|SUPERIORITY||Least Squares Mean Difference|1.78|||||TWO_SIDED|90.0|-0.49|4.06||||||0.5 hour post-dose||4.06|-0.49|
72544940|NCT01743677|144618991|SUPERIORITY||Least Squares Mean Difference|2.99|||||TWO_SIDED|90.0|0.71|5.26||||||1 hour post-dose||5.26|0.71|
72544941|NCT01743677|144618991|SUPERIORITY||Least Squares Mean Difference|1.08|||||TWO_SIDED|90.0|-1.19|3.36||||||2 hours post-dose||3.36|-1.19|
72544942|NCT01743677|144618991|SUPERIORITY||Least Squares Mean Difference|2.16|||||TWO_SIDED|90.0|-0.11|4.44||||||4 hours post-dose||4.44|-0.11|
72544943|NCT01743677|144618991|SUPERIORITY||Least Squares Mean Difference|0.05|||||TWO_SIDED|90.0|-2.22|2.33||||||8 hours post-dose||2.33|-2.22|
72544944|NCT01743677|144618991|SUPERIORITY||Least Squares Mean Difference|0.49|||||TWO_SIDED|90.0|-1.79|2.76||||||12 hours post-dose||2.76|-1.79|
72544945|NCT01743677|144618991|SUPERIORITY||Least Squares Mean Difference|2.1|||||TWO_SIDED|90.0|-0.17|4.38||||||16 hours post-dose||4.38|-0.17|
72544946|NCT01743677|144618991|SUPERIORITY||Least Squares Mean Difference|0.79|||||TWO_SIDED|90.0|-1.49|3.06||||||24 hours post-dose||3.06|-1.49|
72579523|NCT01277211|144687854|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentages, Cycle 10|-2.9||||0.098|TWO_SIDED|95.0|-7.6|0.5|||Miettinen and Nurminen method|||For Cycle 10, a two-sided 95% CI for the difference in percentage between the treatment groups (ENG-EE vs. DRSP-EE) was calculated using the method of Miettinen and Nurminen.||0.5|-7.6|0.098
72579524|NCT01277211|144687854|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentages, Cycle 11|-4.4||||0.009|TWO_SIDED|95.0|-9.4|-1.0|||Miettinen and Nurminen method|||For Cycle 11, a two-sided 95% CI for the difference in percentage between the treatment groups (ENG-EE vs. DRSP-EE) was calculated using the method of Miettinen and Nurminen.||-1.0|-9.4|0.009
72544947|NCT01715415|144619002|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Based on historical SVR rates for noncirrhotic peg-interferon/ribavirin (pegIFN/RBV) treatment-experienced subjects administered telaprevir plus pegIFN/RBV, the lower confidence bound (LCB) of the 95% confidence interval (CI) must have exceeded 60% to achieve noninferiority of the ABT-450/r/ABT-267 and ABT-333, plus RBV treatment group as compared with the historical rate for telaprevir plus pegIFN and RBV, and the LCB of the 95% CI must have exceeded 70% to achieve superiority.|Percentage of Participants with SVR12|96.3|||||TWO_SIDED|95.0|94.1|98.4|||||95% CI calculated using the normal approximation to the binomial distribution. In order to control the Type I error rate at 0.05, a fixed-sequence testing procedure was used to proceed through the primary and numbered secondary efficacy endpoints.|With a sample size of 300 subjects and assuming that 85% of the subjects in Arm A will achieve sustained virologic response (SVR) 12, this study has greater than 90% power to demonstrate non-inferiority with a 2-sided 95% lower confidence bound greater than 60% and greater than 90% power to demonstrate superiority with a 2-sided 95% lower confidence bound greater than 70% (based on the normal approximation of a single binomial proportion).||98.4|94.1|
72544948|NCT01715415|144619003|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||In order to control the Type I error rate at 0.05, a fixed-sequence testing procedure will be used to proceed through the primary and the first 3 secondary endpoints in the order numbered below.|Fisher Exact|||||||<0.001
72544949|NCT01715415|144619004|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Based on historical SVR rates for noncirrhotic pegIFN/RBV treatment-experienced subjects of the appropriate HCV genotype 1 subtype administered telaprevir plus pegIFN/RBV, the lower confidence bound (LCB) of the 95% confidence interval (CI) must have exceeded 65% to achieve superiority of the ABT-450/r/ABT-267 and ABT-333, plus RBV treatment group as compared with the historical rate for telaprevir plus pegIFN and RBV.|Percentage of Participants with SVR12|96.0|||||TWO_SIDED|95.0|93.0|98.9|||||95% CI calculated using the normal approximation to the binomial distribution.|||98.9|93.0|
72544950|NCT01715415|144619005|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Based on historical SVR rates for noncirrhotic pegIFN/RBV treatment-experienced subjects of the appropriate HCV genotype 1 subtype administered telaprevir plus pegIFN/RBV, the lower confidence bound (LCB) of the 95% confidence interval (CI) must have exceeded 77% to achieve superiority of the ABT-450/r/ABT-267 and ABT-333, plus RBV treatment group as compared with the historical rate for telaprevir plus pegIFN and RBV.|Percentage of Participants with SVR12|96.7|||||TWO_SIDED|95.0|93.6|99.9||||||||99.9|93.6|
72544951|NCT03586830|144619030|SUPERIORITY||Difference of least square (LS) means|-4.56|STANDARD_ERROR_OF_MEAN|0.757|<|0.001|TWO_SIDED|95.0|-6.05|-3.06|||Hochberg Approach|||||-3.06|-6.05|<.001
72544952|NCT03586830|144619030|SUPERIORITY||Difference of LS Means|-5.85|STANDARD_ERROR_OF_MEAN|0.755|<|0.001|TWO_SIDED|95.0|-7.34|-4.36|||Hochberg Approach|||||-4.36|-7.34|<.001
72544953|NCT03586830|144619030|SUPERIORITY||Difference of LS Means|-7.23|STANDARD_ERROR_OF_MEAN|0.748|<|0.001|TWO_SIDED|95.0|-8.7|-5.75|||Hochberg Approach|||||-5.75|-8.70|<.001
72544954|NCT04578548|144619034|SUPERIORITY||Geometric Mean Difference|-0.91||||0.606|TWO_SIDED|95.0|-4.34|2.64|||Random coefficient regression model|||Based on a random coefficient regression model (linear slope model) on htTKV log-transformed values with time (in weeks) as a continuous variable, treatment, time-by-treatment interaction and a random intercept and slope. The treatment effect was determined by using estimated slopes for each treatment group on the basis of the time-by-treatment interaction term from the mixed model.||2.64|-4.34|0.606
72544955|NCT04578548|144619036|SUPERIORITY||Least-squares mean difference|-2.31||||0.171|TWO_SIDED|95.0|-5.64|1.02|||Random coefficient regression model|||Least-squares mean difference (95% CI) from a random coefficient regression model (linear slope model) on eGFR values with time (in weeks) as a continuous variable, the time-by-treatment interaction and a random intercept and slope. The treatment effect was determined by using estimated slopes for each treatment group on the basis of the time-by-treatment interaction term from the mixed model.||1.02|-5.64|0.171
72579525|NCT01277211|144687854|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentages, Cycle 12|-6.2||||0.002|TWO_SIDED|95.0|-11.7|-2.1|||Miettinen and Nurminen method|||For Cycle 12, a two-sided 95% CI for the difference in percentage between the treatment groups (ENG-EE vs. DRSP-EE) was calculated using the method of Miettinen and Nurminen.||-2.1|-11.7|0.002
72579526|NCT01277211|144687854|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentages, Cycle 13|-4.5||||0.043|TWO_SIDED|95.0|-10.2|-0.1|||Miettinen and Nurminen method|||For Cycle 13, a two-sided 95% CI for the difference in percentage between the treatment groups (ENG-EE vs. DRSP-EE) was calculated using the method of Miettinen and Nurminen.||-0.1|-10.2|0.043
72579527|NCT00879086|144687855|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportions|-16.7|||=|0.0941|TWO_SIDED|95.0|-36.1|2.4||The two treatment groups were compared, controlling for baseline pre-existing neuropathy (CTCAE Grade 0 or 1) and number of prior chemotherapy regimens (less than or equal to 3 or greater than 3), with both covariates included as binary variables.|Cochran-Mantel-Haenszel||Extended Mantel-Haenszel test statistics with stratification adjustment for pre-existing baseline neuropathy (CTCAE Grade 0 or 1) and number of prior chemotherapy regimens (greater than or equal to 3 or greater than 3)|||2.4|-36.1|=0.0941
72579528|NCT00879086|144687856|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportions|-18.4||||0.0492|TWO_SIDED|95.0|-36.0|-0.3||Controlled for baseline pre-existing neuropathy (CTCAE Grade 0 or 1) and number of prior chemotherapy regimens (greater than or equal to 3 or greater than 3), with both covariates included as binary variables.|Cochran-Mantel-Haenszel||Extended Mantel-Haenszel test statistics with stratification adjustment for pre-existing baseline neuropathy (CTCAE Grade 0 or 1) and number of prior chemotherapy regimens (greater than or equal to 3 or greater than 3)|||-0.3|-36.0|0.0492
72579529|NCT00719186|144687872|SUPERIORITY_OR_OTHER|||||||0.007|||||||Chi-squared|||||||0.007
72579530|NCT01866098|144687926|SUPERIORITY|||||||0.83|||||||Mixed Models Analysis|Estimated treatment differences between groups analyzed using mixed-model analysis. Model includes the baseline value age; sex; compliance; ethnicity.||||||0.83
72579531|NCT01866098|144687927|SUPERIORITY|||||||0.1|||||||Chi-squared|||||||0.10
72579532|NCT01866098|144687928|SUPERIORITY|||||||0.19|||||||Mixed Models Analysis|Estimated treatment differences between groups analyzed using mixed-model analysis. Model includes the baseline value age; sex; compliance; ethnicity.||||||0.19
72579533|NCT01866098|144687929|SUPERIORITY|||||||0.96|||||||Mixed Models Analysis|Estimated treatment differences between groups analyzed using mixed-model analysis. Model includes the baseline value age; sex; compliance; ethnicity.||||||0.96
72544956|NCT00395083|144619040|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.13||||0.62|TWO_SIDED|95.0|0.7|1.8|||Log Rank|||||1.80|0.70|0.62
72544957|NCT00395083|144619041|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.13||||0.62|TWO_SIDED|95.0|0.7|1.8|||Regression, Cox|||||1.80|0.70|0.62
72544958|NCT00395083|144619042|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|3.0||||0.003|TWO_SIDED|95.0|1.46|6.17|||Regression, Cox|||||6.17|1.46|0.003
72544959|NCT00395083|144619043|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|3.0||||0.002|TWO_SIDED|95.0|1.46|6.17|||Log Rank|||||6.17|1.46|0.002
72544960|NCT00972153|144619044|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||Descriptive statistics (means, medians, frequencies) were used to evaluate the distributions of variables. One-way analysis of variance and independent t-tests or Mann-Whitney U tests were used to compare patient and environmental characteristics between groups. Generalized estimating equations were used to evaluate the effects of group and other factors on airborne CFUs/cubic meter at the surgical site in each 10 minute interval.||||<0.001
72544961|NCT00972153|144619045|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||Descriptive statistics (means, medians, frequencies) were used to evaluate the distributions of variables. One-way analysis of variance and independent t-tests or Mann-Whitney U tests were used to compare patient and environmental characteristics between groups. Generalized estimating equations were used to evaluate the effects of group and other factors on airborne CFUs/cubic meter at the surgical site in each 10 minute interval.||||<0.001
72544962|NCT04136626|144619046|SUPERIORITY||Mean Difference (Final Values)|-2.0475||||0.0871|TWO_SIDED|95.0|-4.3977|0.3027||The p-value was not adjusted for multiple comparisons because this was the pre-specified primary endpoint comparison. The a priori threshold for statistical significance was alpha=.05.|Mixed Models Analysis|Repeated measures were modeled with a first-order heterogeneous auto-regressive (ARH(1)) covariance structure.|The effect is presented as the Perspectives OCD group outcome compared to the Health and Well-Being Program group outcome at the trial end-point (week 12).|Null hypothesis: there is no significant difference in Y-BOCS total scores between the treatment groups at endpoint (week 12).||0.3027|-4.3977|0.0871
72544963|NCT04136626|144619046|SUPERIORITY||Difference in the amount of change|-3.4385||||0.0036|TWO_SIDED|95.0|-5.7394|-1.1376||The p-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was alpha=.05.|Mixed Models Analysis|Repeated measures were modeled with a first-order heterogeneous auto-regressive (ARH(1)) covariance structure.|The effect is presented as the difference in the amount of symptom reduction (week 12 - week 0) between Perspectives OCD and the Health and Well-Being Program group (i.e., a group difference in the amount of change over time).|Null hypothesis: there is no significant difference in the change from baseline to end-of-treatment Y-BOCS total scores between the treatment groups.||-1.1376|-5.7394|0.0036
72544964|NCT04136626|144619047|SUPERIORITY||Mean Difference (Final Values)|-0.8743||||0.3616|TWO_SIDED|95.0|-2.7666|1.0181||The a priori threshold for statistical significance was alpha=.05.|Mixed Models Analysis|Repeated measures were modeled with a first-order heterogeneous auto-regressive (ARH(1)) covariance structure.|The effect is presented as the Perspectives OCD group outcome compared to the Health and Well-Being Program group outcome at the trial end-point (week 12).|Null hypothesis: there is no significant difference in depression severity (QIDS-SR total scores) between the treatment groups at endpoint (week 12).||1.0181|-2.7666|0.3616
72544965|NCT04136626|144619047|SUPERIORITY||Difference in the amount of change|-1.3076||||0.1973|TWO_SIDED|95.0|-3.3014|0.6862||The a priori threshold for statistical significance was alpha=.05.|Mixed Models Analysis|Repeated measures were modeled with a first-order heterogeneous auto-regressive (ARH(1)) covariance structure.|The effect is presented as the difference in the amount of symptom reduction (week 12 - week 0) between Perspectives OCD and the Health and Well-Being Program group (i.e., a group difference in the amount of change over time).|Null hypothesis: there is no significant difference in the change from baseline to end-of-treatment depression severity (QIDS-SR total scores) between the treatment groups.||0.6862|-3.3014|0.1973
72544966|NCT04136626|144619048|SUPERIORITY||Mean Difference (Final Values)|-2.7992||||0.1289|TWO_SIDED|95.0|-6.4246|0.8262||The a priori threshold for statistical significance was alpha=.05.|Mixed Models Analysis|Repeated measures were modeled with a first-order heterogeneous auto-regressive (ARH(1)) covariance structure.|The effect is presented as the Perspectives OCD group outcome compared to the Health and Well-Being Program group outcome at the trial end-point (week 12).|Null hypothesis: there is no significant difference in functional impairment (WSAS total scores) between the treatment groups at endpoint (week 12).||0.8262|-6.4246|0.1289
72544967|NCT04136626|144619048|SUPERIORITY||Difference in the amount of change|-4.5704||||0.0137|TWO_SIDED|95.0|-8.1939|-0.9468||The a priori threshold for statistical significance was alpha=.05.|Mixed Models Analysis|Repeated measures were modeled with a first-order heterogeneous auto-regressive (ARH(1)) covariance structure.|The effect is presented as the difference in the amount of symptom reduction (week 12 - week 0) between Perspectives OCD and the Health and Well-Being Program group (i.e., a group difference in the amount of change over time).|Null hypothesis: there is no significant difference in the change from baseline to end-of-treatment functional impairment (WSAS total scores) between the treatment groups.||-0.9468|-8.1939|0.0137
72544968|NCT04136626|144619049|SUPERIORITY||Mean Difference (Final Values)|4.3953||||0.1796|TWO_SIDED|95.0|-2.0543|10.8448||The a priori threshold for statistical significance was alpha=.05.|Mixed Models Analysis|Repeated measures were modeled with a first-order heterogeneous auto-regressive (ARH(1)) covariance structure.|The effect is presented as the Perspectives OCD group outcome compared to the Health and Well-Being Program group outcome at the trial end-point (week 12).|Null hypothesis: there is no significant difference in quality of life (Q-LES-Q-SF percentage scores) between the treatment groups at endpoint (week 12).||10.8448|-2.0543|0.1796
72579534|NCT01866098|144687930|SUPERIORITY|||||||0.92|||||||Mixed Models Analysis|Estimated treatment differences between groups analyzed using mixed-model analysis. Model includes the baseline value age; sex; compliance; ethnicity.||||||0.92
72579535|NCT01866098|144687931|SUPERIORITY|||||||0.98|||||||Mixed Models Analysis|Estimated treatment differences between groups analyzed using mixed-model analysis. Model includes the baseline value age; sex; compliance; ethnicity.||||||0.98
72579536|NCT01866098|144687932|SUPERIORITY|||||||0.95|||||||Mixed Models Analysis|Estimated treatment differences between groups analyzed using mixed-model analysis. Model includes the baseline value age; sex; compliance; ethnicity.||||||0.95
72411443|NCT01700946|144331281|SUPERIORITY|||||||0.1181|||||||Fisher Exact|||||||0.1181
72544969|NCT04136626|144619049|SUPERIORITY||Difference in the amount of change|6.7962||||0.04|TWO_SIDED|95.0|0.314|13.2785||The a priori threshold for statistical significance was alpha=.05.|Mixed Models Analysis|Repeated measures were modeled with a first-order heterogeneous auto-regressive (ARH(1)) covariance structure.|The effect is presented as the difference in the amount of symptom reduction (week 12 - week 0) between Perspectives OCD and the Health and Well-Being Program group (i.e., a group difference in the amount of change over time).|Null hypothesis: there is no significant difference in the change from baseline to end-of-treatment quality of life (Q-LES-Q-SF percentage scores) between the treatment groups.||13.2785|0.3140|0.0400
72544970|NCT02410252|144619103|OTHER||%|100.0|||||TWO_SIDED|||||There was no statistical analysis conducted on demographic characteristics or baseline surveys|descriptive analysis|||Descriptive statistics were used to characterize the study sample, and survey responses.||||
72544971|NCT02410252|144619103|OTHER|Only percents were calculated, no formal statistical analysis was completed.||||||||||||Statistical analysis was not completed. This was a feasibility study with small n and was not powered to determine statistical significance.||||Only percent will be calculated. No statistical analysis will be conducted.|No statistical analysis was conducted as part of this study.|||
72544972|NCT02410252|144619104|OTHER||%|0.29||||0.13|TWO_SIDED|||||Significance was set at p\<0.05|Cochran-Mantel-Haenszel|||"GAD-7 scores were coded as a categorical variable as follows: mild anxiety (total score 0 to 5) and moderate/ severe anxiety (total score 6-15).~Proportion of participants with mild and moderate/ severe anxiety at enrollment and closeout was compared using Cochran's Q test."||||0.13
72544973|NCT02410252|144619105|OTHER||%|84.0||||0.05|TWO_SIDED||||||descriptive analysis|||Descriptive statistics were used to characterize the study sample, and survey responses. All analysis was conducted using STATA version 14.2 with an alpha of 0.05 set a priori. Since this was an exploratory study with descriptive statistics, a complete case analysis approach was adopted for this study||||0.05
72579537|NCT01866098|144687933|SUPERIORITY|||||||0.43|||||||Mixed Models Analysis|Estimated treatment differences between groups analyzed using mixed-model analysis. Model includes the baseline value age; sex; compliance; ethnicity.||||||0.43
72579538|NCT03649347|144687934|SUPERIORITY||||||<|0.001||||||Interaction effect: p\<.001, np2=.720|ANOVA|Main effect of time: p\<.001, np2=.798; main effect of group: p\<.001, np2=.711||A repeated measures ANOVA was conducted to assess main effects of group (AR therapy intervention versus no treatment control), time (baseline, one week follow up, and one month follow up) as well as an interaction effect. The P-Value shown below is for the interaction effect. Post-hoc power analysis indicated actual power 99%, critical F=4.76.||||<.001
72579539|NCT03649347|144687935|SUPERIORITY||||||<|0.001||||||Interaction effect: p\<.001, np2=.542|ANOVA|Main effect of time: p\<.001, np2=.598; and main effect of group: p\<.001, np2=.439||A repeated measures ANOVA was conducted to assess main effects of group (AR therapy intervention versus no treatment control), time (baseline, one week follow up, and one month follow up) as well as an interaction effect. The P-Value shown below is for the interaction effect. Post-hoc power analysis indicated actual power 96%, critical F=4.76.||||<.001
72579540|NCT03649347|144687937|SUPERIORITY||||||<|0.005||||||Interaction effect: p\<.005, np2=.481|ANOVA|Main effect of time: p\<.001, np2=.572; and main effect of group p\<.001, np2=.626||A repeated measures ANOVA was conducted to assess main effects of group (AR therapy intervention versus no treatment control), time (baseline, one week follow up, and one month follow up) as well as an interaction effect. The P-Value shown below is for the interaction effect. Post-hoc power analysis indicated actual power 99%, critical F=3.49.||||<.005
72579541|NCT02517463|144687954|NON_INFERIORITY_OR_EQUIVALENCE|"The PPP from a previous study was 67.2%. Assuming the PPP in the preovulatory and post-ovulatory groups were equivalent, and taking 10% to be the maximum permitted difference for equivalence, a minimum of 273 subjects in each group would be required to confirm equivalence between the two groups with a power of 80% and type I error of 0.05. Therefore, our recruitment of 700 subjects with more than 300 in each group was sufficient."|||||<|0.0001|||||||Chi-squared|||||||<0.0001
72544974|NCT00387712|144619107|OTHER|Analysis of variance between groups across time is the primary analyses.||||||0.001||||||Group (high velocity training vs. low velocity duration training) by time (baseline to post-6 months) for the primary outcome category (peak fitness) using repeated measures analysis of variance. No adjustment for multiple comparisons is needed.|ANOVA|No other adjustments such as degrees of freedom was necessary.||"Power Calculation: It was calculated that 29 subjects should be randomized to 2 groups to achieve a significant time by group interaction for peak fitness for high-velocity or low velocity duration training groups, assuming a power of 90 percent power and alpha = 0.01, two-tailed analyses.~Primary analyses is a group by time analysis of variance in peak fitness levels between the higher-intensity and lower intensity training groups across baseline to 6 months post-exercise time points."||||0.001
72544975|NCT00387712|144619108|OTHER|Primary analyses is a group by time analysis of variance in myosin heavy chain levels levels between the higher-intensity and lower intensity training groups across baseline to 6 months post-exercise time points.||||||0.11|||||||ANOVA|||Power Calculation: It was calculated that 22 participants should be randomized to 2 groups to achieve a significant time by group interaction for myosin heavy chain isoforms for high-velocity or low velocity duration training groups, assuming a power of 90 percent power and alpha = 0.01, two-tailed analyses.||||0.11
72544976|NCT00387712|144619109|OTHER|Analysis of variance between groups across time is the primary analyses.||||||0.81||||||Group (high velocity training vs. low velocity duration training) by time (baseline to post-6 months) for the secondary outcome category (30 ft walk time - fastest comfortable gait) using repeated measures analysis of variance.|ANOVA|No other adjustments such as degrees of freedom was necessary.||Primary analyses is a group by time analysis of variance in 30 foot walk time (sec) between the higher-intensity and lower intensity training groups across baseline to 6 months post-exercise time points.||||0.81
72544977|NCT00322309|144619121|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.9|STANDARD_DEVIATION|2.6|>|0.05|TWO_SIDED|95.0|||||t-test, 2 sided|||It was hypothesized that there would be no significant difference between the two treatment groups for benzoylecgonine data collected for Week 11.||||>0.05
72579542|NCT02517463|144687955|SUPERIORITY_OR_OTHER|||||||0.564|TWO_SIDED||||||Fisher Exact|||||||0.564
72544978|NCT00322309|144619122|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.8|STANDARD_DEVIATION|6.6|>|0.05|TWO_SIDED|95.0|||||t-test, 2 sided|||It was hypothesized that means scores for the CGI-O would not differ significantly for these values obtained in the final treatment week, Week 11.||||>0.05
72544979|NCT00322309|144619123|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.05|STANDARD_DEVIATION|5.4|>|0.05|TWO_SIDED|||||This analysis involves a between group comparison.|t-test, 2 sided|||It hypothesized that the two treatment groups would not differ significantly with respect to the total HAM-D scores obtained in the final week of the study (Week 11).||||>0.05
72544980|NCT00322309|144619124|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0|STANDARD_DEVIATION|18.0|>|0.05||95.0||||Percent of capsules administered does not differ significantly between the two groups.|t-test, 2 sided|||It was hypothesized that there would be no significant difference in the mean percentage of capsules of those dispensed between the two groups.||||>0.05
72544981|NCT00322309|144619125|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0|STANDARD_DEVIATION|8.5|>|0.05||95.0|||||t-test, 2 sided|||It was hypothesized that there would not be a significant difference between the two groups in the mean percent of urines positive for riboflavin.||||>0.05
72544982|NCT01772368|144619129|OTHER|linearity statistical test|||||<|0.0001||||||A fixed-sequence testing procedure was employed to control the overall Type I error rate at the 2 sided 0.05 level.|ANCOVA|Fixed effects of sequence, period and treatment; a random effect of subject within sequence; and a covariate of period-specific baseline FEV1.||A linear in log-dose-trend contrast was constructed to evaluate the dose-response trend, where the logarithm of dose was defined precisely as log (dose+1) to accommodate the case of Fp MDPI 100 mcg, since the dose used in this trend analysis was the salmeterol dose. The study was considered positive if the trend test was positive and the test involving the highest FS MDPI dose (100/50 mcg) compared with Fp MDPI 100 mcg was positive, regardless of the results of the tests for the other doses.||||<0.0001
72579543|NCT02517463|144687956|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
72579544|NCT03449446|144687959|SUPERIORITY||Difference in percentages|0.6||||0.9449|TWO_SIDED|95.0|-17.6|18.8||The p-value between each pair of treatment groups presented were obtained by the stratum-adjusted Mantel-Haenszel (MH) method, with baseline diabetes mellitus status and baseline cirrhosis status as stratification factors.|Mantel Haenszel||The percentage difference and 95% C.I. presented were obtained by the stratum-adjusted MH method, with baseline diabetes mellitus status and baseline cirrhosis status as stratification factors.|||18.8|-17.6|0.9449
72544983|NCT01772368|144619129|SUPERIORITY||LSM difference|251.3|||<|0.0001|TWO_SIDED|95.0|215.6|287.1||A fixed-sequence testing procedure was employed to control the overall Type I error rate at the 2 sided 0.05 level.|ANCOVA|Fixed effects of sequence, period and treatment; a random effect of subject within sequence; and a covariate of period-specific baseline FEV1.|FS MDPI 100/50 mcg - Fp MDPI 100 mcg|The estimated treatment difference from the ANCOVA model between FS MDPI 100/50 mcg dose group and Fp MDPI 100 mcg group is presented together with the two-sided 95% CI for the difference and the p-value.||287.1|215.6|<0.0001
72544984|NCT01772368|144619129|SUPERIORITY||LSM difference|227.56|||<|0.0001|TWO_SIDED|95.0|191.6|263.5||A fixed-sequence testing procedure was employed to control the overall Type I error rate at the 2 sided 0.05 level.|ANCOVA|Fixed effects of sequence, period and treatment; a random effect of subject within sequence; and a covariate of period-specific baseline FEV1.|FS MDPI 100/25 mcg - Fp MDPI 100 mcg|The estimated treatment difference from the ANCOVA model between FS MDPI 100/25 mcg dose group and Fp MDPI 100 mcg group is presented together with the two-sided 95% CI for the difference and the p-value.||263.5|191.6|<0.0001
72579545|NCT03449446|144687959|SUPERIORITY||Difference in percentages|0.4||||0.9646|TWO_SIDED|95.0|-17.6|18.4||The p-value between each pair of treatment groups presented were obtained by the stratum-adjusted MH method, with baseline diabetes mellitus status and baseline cirrhosis status as stratification factors.|Mantel Haenszel||The percentage difference and 95% C.I. presented were obtained by the stratum-adjusted MH method, with baseline diabetes mellitus status and baseline cirrhosis status as stratification factors.|||18.4|-17.6|0.9646
72544985|NCT01772368|144619129|SUPERIORITY||LSM difference|196.85|||<|0.0001|TWO_SIDED|95.0|161.2|232.5||A fixed-sequence testing procedure was employed to control the overall Type I error rate at the 2 sided 0.05 level.|ANCOVA|Fixed effects of sequence, period and treatment; a random effect of subject within sequence; and a covariate of period-specific baseline FEV1.|FS MDPI 100/12.5 mcg - Fp MDPI 100 mcg|The estimated treatment difference from the ANCOVA model between FS MDPI 100/512.5 mcg dose group and Fp MDPI 100 mcg group is presented together with the two-sided 95% CI for the difference and the p-value.||232.5|161.2|<0.0001
72544986|NCT01772368|144619129|SUPERIORITY||LSM difference|151.71|||<|0.0001|TWO_SIDED|95.0|115.9|187.5||A fixed-sequence testing procedure was employed to control the overall Type I error rate at the 2 sided 0.05 level.|ANCOVA|Fixed effects of sequence, period and treatment; a random effect of subject within sequence; and a covariate of period-specific baseline FEV1.|FS MDPI 100/6.25 mcg - Fp MDPI 100 mcg|The estimated treatment difference from the ANCOVA model between FS MDPI 100/6.25 mcg dose group and Fp MDPI 100 mcg group is presented together with the two-sided 95% CI for the difference and the p-value.||187.5|115.9|<0.0001
72544987|NCT01772368|144619129|SUPERIORITY||LSM difference|193.42|||<|0.0001|TWO_SIDED|95.0|157.4|229.5||A fixed-sequence testing procedure was employed to control the overall Type I error rate at the 2 sided 0.05 level.|ANCOVA|Fixed effects of sequence, period and treatment; a random effect of subject within sequence; and a covariate of period-specific baseline FEV1.|Advair Diskus 100/50 mcg - Fp MDPI 100|The estimated treatment difference from the ANCOVA model between Advair Diskus 100/50 mcg dose group and Fp MDPI 100 mcg group is presented together with the two-sided 95% CI for the difference and the p-value.||229.5|157.4|<0.0001
72544988|NCT01772368|144619129|SUPERIORITY||LSM difference|57.88||||0.0017|TWO_SIDED|95.0|22.0|93.7||A fixed-sequence testing procedure was employed to control the overall Type I error rate at the 2 sided 0.05 level.|ANCOVA|Fixed effects of sequence, period and treatment; a random effect of subject within sequence; and a covariate of period-specific baseline FEV1.|FS MDPI 100/50 - Advair Diskus 100/50 mcg|The estimated treatment difference from the ANCOVA model between FS MDPI 100/50 mcg dose group and Advair Diskus 100/50 mcg group is presented together with the two-sided 95% CI for the difference and the p-value.||93.7|22.0|0.0017
72544989|NCT01772368|144619129|SUPERIORITY||LSM difference|34.14||||0.0624|TWO_SIDED|95.0|-1.8|70.1||A fixed-sequence testing procedure was employed to control the overall Type I error rate at the 2 sided 0.05 level.|ANCOVA|Fixed effects of sequence, period and treatment; a random effect of subject within sequence; and a covariate of period-specific baseline FEV1.|FS MDPI 100/25 mcg - Advair Diskus 100/50 mcg|The estimated treatment difference from the ANCOVA model between FS MDPI 100/25 mcg dose group and Advair Diskus 100/50 mcg group is presented together with the two-sided 95% CI for the difference and the p-value.||70.1|-1.8|0.0624
72544990|NCT01772368|144619129|SUPERIORITY||LSM difference|3.42||||0.8503|TWO_SIDED|95.0|-32.3|39.1||A fixed-sequence testing procedure was employed to control the overall Type I error rate at the 2 sided 0.05 level.|ANCOVA|Fixed effects of sequence, period and treatment; a random effect of subject within sequence; and a covariate of period-specific baseline FEV1.|FS MDPI 100/12.5mcg - Advair Diskus 100/50 mcg|The estimated treatment difference from the ANCOVA model between FS MDPI 100/12.5 mcg dose group and Advair Diskus 100/50 mcg group is presented together with the two-sided 95% CI for the difference and the p-value.||39.1|-32.3|0.8503
72579546|NCT03449446|144687959|SUPERIORITY||Difference in percentages|3.7||||0.6219|TWO_SIDED|95.0|-10.9|18.3||The p-value between each pair of treatment groups presented were obtained by the stratum-adjusted MH method, with baseline diabetes mellitus status and baseline cirrhosis status as stratification factors.|Mantel Haenszel||The percentage difference and 95% C.I. presented were obtained by the stratum-adjusted MH method, with baseline diabetes mellitus status and baseline cirrhosis status as stratification factors.|||18.3|-10.9|0.6219
72579547|NCT03449446|144687959|SUPERIORITY||Difference in percentages|8.8||||0.2554|TWO_SIDED|95.0|-6.4|24.1||The p-value between each pair of treatment groups presented were obtained by the stratum-adjusted MH method, with baseline diabetes mellitus status and baseline cirrhosis status as stratification factors.|Mantel Haenszel||The percentage difference and 95% C.I. presented were obtained by the stratum-adjusted MH method, with baseline diabetes mellitus status and baseline cirrhosis status as stratification factors.|||24.1|-6.4|0.2554
72579548|NCT03449446|144687959|SUPERIORITY||Difference in percentages|10.8||||0.1658|TWO_SIDED|95.0|-4.5|26.1||The p-value between each pair of treatment groups presented were obtained by the stratum-adjusted MH method, with baseline diabetes mellitus status and baseline cirrhosis status as stratification factors.|Mantel Haenszel||The percentage difference and 95% C.I. presented were obtained by the stratum-adjusted MH method, with baseline diabetes mellitus status and baseline cirrhosis status as stratification factors.|||26.1|-4.5|0.1658
72579549|NCT03449446|144687959|SUPERIORITY||Difference in percentages|3.2||||0.6963|TWO_SIDED|95.0|-12.9|19.4||The p-value between each pair of treatment groups presented were obtained by the stratum-adjusted MH method, with baseline diabetes mellitus status and baseline cirrhosis status as stratification factors.|Mantel Haenszel||The percentage difference and 95% C.I. presented were obtained by the stratum-adjusted MH method, with baseline diabetes mellitus status and baseline cirrhosis status as stratification factors.|||19.4|-12.9|0.6963
72579550|NCT03449446|144687959|SUPERIORITY||Difference in percentages|10.0||||0.2441|TWO_SIDED|95.0|-6.8|26.8||The p-value between each pair of treatment groups presented were obtained by the stratum-adjusted MH method, with baseline diabetes mellitus status and baseline cirrhosis status as stratification factors.|Mantel Haenszel||The percentage difference and 95% C.I. presented were obtained by the stratum-adjusted MH method, with baseline diabetes mellitus status and baseline cirrhosis status as stratification factors.|||26.8|-6.8|0.2441
72579551|NCT03449446|144687959|SUPERIORITY||Difference in percentages|5.2||||0.5229|TWO_SIDED|95.0|-10.7|21.0||The p-value between each pair of treatment groups presented were obtained by the stratum-adjusted MH method, with baseline diabetes mellitus status and baseline cirrhosis status as stratification factors.|Mantel Haenszel||The percentage difference and 95% C.I. presented were obtained by the stratum-adjusted MH method, with baseline diabetes mellitus status and baseline cirrhosis status as stratification factors.|||21.0|-10.7|0.5229
72579552|NCT03449446|144687959|SUPERIORITY||Difference in percentages|10.4||||0.2149|TWO_SIDED|95.0|-6.0|26.9||The p-value between each pair of treatment groups presented were obtained by the stratum-adjusted MH method, with baseline diabetes mellitus status and baseline cirrhosis status as stratification factors.|Mantel Haenszel||The percentage difference and 95% C.I. presented were obtained by the stratum-adjusted MH method, with baseline diabetes mellitus status and baseline cirrhosis status as stratification factors.|||26.9|-6.0|0.2149
72579553|NCT02448368|144687960|NON_INFERIORITY_OR_EQUIVALENCE|The sample size is not based on formal power calculations, as this study is designed only to provide an initial assessment of the Pharmacokinetics (PK), Pharmacodynamics (PD), and safety profile of RDEA3170.|Geometric Least Squares Mean Ratio|232.0|||||TWO_SIDED|90.0|202.0|266.0|||Mixed Models Analysis|A mixed effect model on the natural log-transformed PK parameters Cmax, AUClast, and AUC∞ with fixed effect for treatment.||||266|202|
72579554|NCT02448368|144687960|NON_INFERIORITY_OR_EQUIVALENCE|The sample size is not based on formal power calculations, as this study is designed only to provide an initial assessment of the PK, PD, and safety profile of RDEA3170.|Geometric Least Squares mean Ratio|181.0|||||TWO_SIDED|90.0|164.0|200.0|||Mixed Models Analysis|A mixed effect model on the natural log-transformed PK parameters Cmax, AUClast, and AUC∞ with fixed effect for treatment.||||200|164|
72411444|NCT01168934|144331293|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|43.44|||||TWO_SIDED|90.0|39.68|47.56||||||Natural log transformed AUC (0 - ∞)(dn) of crizotinib was analyzed using mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% confidence intervals (CIs) for the differences was exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||47.56|39.68|
72411445|NCT01168934|144331296|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|44.67|||||TWO_SIDED|90.0|40.9|48.78||||||Natural log transformed AUClast(dn) of crizotinib was analyzed using mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences was exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||48.78|40.90|
72411446|NCT01504438|144331311|OTHER|||||||0.29|||||||ANOVA|||||||0.29
72411447|NCT01504438|144331312|OTHER|||||||0.31|||||||ANOVA|||||||0.31
72411448|NCT01504438|144331313|OTHER|||||||0.07|||||||ANOVA|||||||0.07
72411449|NCT01504438|144331314|OTHER|||||||0.04|||||||ANOVA|||||||0.04
72411450|NCT04666441|144331363|SUPERIORITY||Difference of LS Means|-0.57|STANDARD_ERROR_OF_MEAN|0.16||0.0004|TWO_SIDED|95.0|-0.88|-0.25|||ANCOVA|||Difference vs. Placebo (log10 copies/mL)||-0.25|-0.88|0.0004
72411451|NCT04666441|144331363|SUPERIORITY||Difference of LS Means|-0.66|STANDARD_ERROR_OF_MEAN|0.17|<|0.0001|TWO_SIDED|95.0|-0.99|-0.34|||ANCOVA|||Difference vs. Placebo (log10 copies/mL)||-0.34|-0.99|<0.0001
72544991|NCT01772368|144619129|SUPERIORITY||LSM difference|-41.72||||0.0229|TWO_SIDED|95.0|-77.6|-5.8||A fixed-sequence testing procedure was employed to control the overall Type I error rate at the 2 sided 0.05 level.|ANCOVA|Fixed effects of sequence, period and treatment; a random effect of subject within sequence; and a covariate of period-specific baseline FEV1.|FS MDPI 100/6.25 mcg - Advair Diskus 100/50 mcg|The estimated treatment difference from the ANCOVA model between FS MDPI 100/6.25 mcg dose group and Advair Diskus 100/50 mcg group is presented together with the two-sided 95% CI for the difference and the p-value.||-5.8|-77.6|0.0229
72544992|NCT01772368|144619129|SUPERIORITY||LSM difference|-193.42|||<|0.0001|TWO_SIDED|95.0|-229.5|-157.4||A fixed-sequence testing procedure was employed to control the overall Type I error rate at the 2 sided 0.05 level.|ANCOVA|Fixed effects of sequence, period and treatment; a random effect of subject within sequence; and a covariate of period-specific baseline FEV1.|Fp MDPI 100 mcg - Advair Diskus 100/50 mcg|The estimated treatment difference from the ANCOVA model between Fp MDPI 100 mcg dose group and Advair Diskus 100/50 mcg group is presented together with the two-sided 95% CI for the difference and the p-value.||-157.4|-229.5|<0.0001
72579555|NCT02448368|144687960|NON_INFERIORITY_OR_EQUIVALENCE|The sample size is not based on formal power calculations, as this study is designed only to provide an initial assessment of the PK, PD, and safety profile of RDEA3170.|Geometric Least Squares mean Ratio|106.0|||||TWO_SIDED|90.0|91.5|124.0|||Mixed Models Analysis|A mixed effect model on the natural log-transformed PK parameters Cmax, AUClast, and AUC∞ with fixed effect for treatment.||||124|91.5|
72579556|NCT02448368|144687962|NON_INFERIORITY_OR_EQUIVALENCE|The sample size is not based on formal power calculations, as this study is designed only to provide an initial assessment of the PK, PD, and safety profile of RDEA3170.|Geometric Least Squares mean Ratio|170.0|||||TWO_SIDED|90.0|147.0|195.0|||Mixed Models Analysis|A mixed effect model on the natural log-transformed PK parameters Cmax, AUClast, and AUC∞ with fixed effect for treatment.||||195|147|
72579557|NCT02448368|144687962|NON_INFERIORITY_OR_EQUIVALENCE|The sample size is not based on formal power calculations, as this study is designed only to provide an initial assessment of the PK, PD, and safety profile of RDEA3170.|Geometric Least Squares mean Ratio|170.0|||||TWO_SIDED|90.0|146.0|199.0|||Mixed Models Analysis|A mixed effect model on the natural log-transformed PK parameters Cmax, AUClast, and AUC∞ with fixed effect for treatment.||||199|146|
72579558|NCT02448368|144687962|NON_INFERIORITY_OR_EQUIVALENCE|The sample size is not based on formal power calculations, as this study is designed only to provide an initial assessment of the PK, PD, and safety profile of RDEA3170.|Geometric Least Squares mean Ratio|129.0|||||TWO_SIDED|90.0|114.0|146.0|||Mixed Models Analysis|A mixed effect model on the natural log-transformed PK parameters Cmax, AUClast, and AUC∞ with fixed effect for treatment.||||146|114|
72579559|NCT02448368|144687963|NON_INFERIORITY_OR_EQUIVALENCE|The sample size is not based on formal power calculations, as this study is designed only to provide an initial assessment of the PK, PD, and safety profile of RDEA3170.|Geometric Least Squares mean Ratio|161.0|||||TWO_SIDED|90.0|139.0|187.0|||Mixed Models Analysis|A mixed effect model on the natural log-transformed PK parameters Cmax, AUClast, and AUC∞ with fixed effect for treatment.||||187|139|
72579560|NCT02448368|144687963|NON_INFERIORITY_OR_EQUIVALENCE|The sample size is not based on formal power calculations, as this study is designed only to provide an initial assessment of the PK, PD, and safety profile of RDEA3170.|Geometric Least Squares mean Ratio|159.0|||||TWO_SIDED|90.0|135.0|188.0|||Mixed Models Analysis|A mixed effect model on the natural log-transformed PK parameters Cmax, AUClast, and AUC∞ with fixed effect for treatment.||||188|135|
72579561|NCT02448368|144687963|NON_INFERIORITY_OR_EQUIVALENCE|The sample size is not based on formal power calculations, as this study is designed only to provide an initial assessment of the PK, PD, and safety profile of RDEA3170.|Geometric Least Squares mean Ratio|131.0|||||TWO_SIDED|90.0|116.0|147.0|||Mixed Models Analysis|A mixed effect model on the natural log-transformed PK parameters Cmax, AUClast, and AUC∞ with fixed effect for treatment.||||147|116|
72579562|NCT02448368|144687965|NON_INFERIORITY_OR_EQUIVALENCE|The sample size is not based on formal power calculations, as this study is designed only to provide an initial assessment of the PK, PD, and safety profile of RDEA3170.|Geometric Least Squares mean Ratio|99.4|||||TWO_SIDED|90.0|88.3|112.0|||Mixed Models Analysis|A mixed effect model on the natural log-transformed PK parameters Cmax, AUClast, and AUC∞ with fixed effect for treatment.||||112|88.3|
72411452|NCT04666441|144331363|SUPERIORITY||Difference of LS Means|-0.56|STANDARD_ERROR_OF_MEAN|0.16||0.0007|TWO_SIDED|95.0|-0.89|-0.24|||ANCOVA|||Difference vs. Placebo (log10 copies/mL)||-0.24|-0.89|0.0007
72411453|NCT04666441|144331363|SUPERIORITY||Difference of LS Means|-0.71|STANDARD_ERROR_OF_MEAN|0.17|<|0.0001|TWO_SIDED|95.0|-1.05|-0.38|||ANCOVA|||Difference vs. Placebo (log10 copies/mL)||-0.38|-1.05|<0.0001
72411454|NCT04666441|144331363|SUPERIORITY||Difference of LS Means|-0.56|STANDARD_ERROR_OF_MEAN|0.16||0.0006||95.0|-0.88|-0.24|||ANCOVA|||Difference vs. Placebo (log10 copies/mL)||-0.24|-0.88|0.0006
72579563|NCT02448368|144687965|NON_INFERIORITY_OR_EQUIVALENCE|The sample size is not based on formal power calculations, as this study is designed only to provide an initial assessment of the PK, PD, and safety profile of RDEA3170.|Geometric Least Squares mean Ratio|99.9|||||TWO_SIDED|90.0|85.5|117.0|||Mixed Models Analysis|A mixed effect model on the natural log-transformed PK parameters Cmax, AUClast, and AUC∞ with fixed effect for treatment.||||117|85.5|
72579564|NCT02448368|144687965|NON_INFERIORITY_OR_EQUIVALENCE|The sample size is not based on formal power calculations, as this study is designed only to provide an initial assessment of the PK, PD, and safety profile of RDEA3170.|Geometric Least Squares mean Ratio|116.0|||||TWO_SIDED|90.0|94.8|143.0|||Mixed Models Analysis|A mixed effect model on the natural log-transformed PK parameters Cmax, AUClast, and AUC∞ with fixed effect for treatment.||||143|94.8|
72579565|NCT02448368|144687966|NON_INFERIORITY_OR_EQUIVALENCE|The sample size is not based on formal power calculations, as this study is designed only to provide an initial assessment of the PK, PD, and safety profile of RDEA3170.|Geometric Least Squares mean Ratio|107.0|||||TWO_SIDED|90.0|98.3|116.0|||Mixed Models Analysis|A mixed effect model on the natural log-transformed PK parameters Cmax, AUClast, and AUC∞ with fixed effect for treatment.||||116|98.3|
72411455|NCT04666441|144331363|SUPERIORITY||Difference of LS Means|-0.56|STANDARD_ERROR_OF_MEAN|0.16||0.0007||95.0|-0.87|-0.24|||ANCOVA|||Difference vs. Placebo (log10 copies/mL)||-0.24|-0.87|0.0007
72411456|NCT04666441|144331364|SUPERIORITY||Difference of LS Means|-0.47|STANDARD_ERROR_OF_MEAN|0.13||0.0002||95.0|-0.72|-0.23|||ANCOVA|||||-0.23|-0.72|0.0002
72411457|NCT04666441|144331364|SUPERIORITY||Difference of LS Means|-0.57|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001||95.0|-0.82|-0.32|||ANCOVA|||||-0.32|-0.82|<0.0001
72544993|NCT01772368|144619130|SUPERIORITY||LSM difference|226.77|||<|0.0001|TWO_SIDED|95.0|172.4|281.1||significance of 0.05 or alpha of 0.05.|ANCOVA|Fixed effects of sequence, period and treatment; a random effect of subject within sequence; and a covariate of period-specific baseline FEV1.|FS MDPI 100/50 mcg - Fp MDPI 100 mcg|The estimated treatment difference from the ANCOVA model between each FS MDPI 100/50 mcg dose group and Fp MDPI 100 mcg group is presented together with the two-sided 95% CI for the difference and the p-value.||281.1|172.4|<0.0001
72544994|NCT01772368|144619130|SUPERIORITY||LSM difference|198.32|||<|0.0001|TWO_SIDED|95.0|143.7|252.9||significance of 0.05 or alpha of 0.05.|ANCOVA|Fixed effects of sequence, period and treatment; a random effect of subject within sequence; and a covariate of period-specific baseline FEV1.|FS MDPI 100/25 mcg - Fp MDPI 100 mcg|The estimated treatment difference from the ANCOVA model between each FS MDPI 100/25 mcg dose group and Fp MDPI 100 mcg group is presented together with the two-sided 95% CI for the difference and the p-value.||252.9|143.7|<0.0001
72544995|NCT01772368|144619130|SUPERIORITY||LSM difference|158.99|||<|0.0001|TWO_SIDED|95.0|104.7|213.3||significance of 0.05 or alpha of 0.05.|ANCOVA|Fixed effects of sequence, period and treatment; a random effect of subject within sequence; and a covariate of period-specific baseline FEV1.|FS MDPI 100/12.5 mcg - Fp MDPI 100 mcg|The estimated treatment difference from the ANCOVA model between each FS MDPI 100/12.5 mcg dose group and Fp MDPI 100 mcg group is presented together with the two-sided 95% CI for the difference and the p-value.||213.3|104.7|<0.0001
72544996|NCT01772368|144619130|SUPERIORITY||LSM difference|116.96|||<|0.0001|TWO_SIDED|95.0|62.4|171.6||significance of 0.05 or alpha of 0.05.|ANCOVA|Fixed effects of sequence, period and treatment; a random effect of subject within sequence; and a covariate of period-specific baseline FEV1.|FS MDPI 100/6.25 mcg - Fp MDPI 100 mcg|The estimated treatment difference from the ANCOVA model between each FS MDPI 100/6.25 mcg dose group and Fp MDPI 100 mcg group is presented together with the two-sided 95% CI for the difference and the p-value.||171.6|62.4|<0.0001
72544997|NCT01772368|144619130|SUPERIORITY||LSM difference|159.01|||<|0.0001|TWO_SIDED|95.0|104.3|213.7||significance of 0.05 or alpha of 0.05.|ANCOVA|Fixed effects of sequence, period and treatment; a random effect of subject within sequence; and a covariate of period-specific baseline FEV1.|Advair Diskus 100/50 mcg - Fp MDPI 100 mcg|The estimated treatment difference from the ANCOVA model between each Advair Diskus 100/50 mcg dose group and Fp MDPI 100 mcg group is presented together with the two-sided 95% CI for the difference and the p-value.||213.7|104.3|<0.0001
72544998|NCT01772368|144619130|SUPERIORITY||LSM difference|67.76||||0.015|TWO_SIDED|95.0|13.3|122.2||significance of 0.05 or alpha of 0.05.|ANCOVA|Fixed effects of sequence, period and treatment; a random effect of subject within sequence; and a covariate of period-specific baseline FEV1.|FS MDPI 100/50 mcg - Advair Diskus 100/50 mcg|The estimated treatment difference from the ANCOVA model between each FS MDPI 100/50 mcg dose group and Advair Diskus 100/50 mcg group is presented together with the two-sided 95% CI for the difference and the p-value.||122.2|13.3|0.0150
72411458|NCT04666441|144331364|SUPERIORITY||Difference of LS Means|-0.58|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001||95.0|-0.83|-0.33|||ANCOVA|||||-0.33|-0.83|<0.0001
72411459|NCT04666441|144331364|SUPERIORITY||Difference of LS Means|-0.49|STANDARD_ERROR_OF_MEAN|0.13||0.0002||95.0|-0.75|-0.24|||ANCOVA|||||-0.24|-0.75|0.0002
72411460|NCT04666441|144331364|SUPERIORITY||Difference of LS Means|-0.37|STANDARD_ERROR_OF_MEAN|0.13||0.004||95.0|-0.62|-0.12|||ANCOVA|||||-0.12|-0.62|0.0040
72411461|NCT04666441|144331364|SUPERIORITY||Difference of LS Means|-0.42|STANDARD_ERROR_OF_MEAN|0.12||0.0007||95.0|-0.67|-0.18|||ANCOVA|||||-0.18|-0.67|0.0007
72544999|NCT01772368|144619130|SUPERIORITY||LSM difference|39.31||||0.1578|TWO_SIDED|95.0|-15.3|94.0||significance of 0.05 or alpha of 0.05.|ANCOVA|Fixed effects of sequence, period and treatment; a random effect of subject within sequence; and a covariate of period-specific baseline FEV1.|FS MDPI 100/25 mcg - Advair Diskus 100/50 mcg|The estimated treatment difference from the ANCOVA model between each FS MDPI 100/25 mcg dose group and Advair Diskus 100/50 mcg group is presented together with the two-sided 95% CI for the difference and the p-value.||94.0|-15.3|0.1578
72545000|NCT01772368|144619130|SUPERIORITY||LSM difference|-0.02||||0.9993|TWO_SIDED|95.0|-54.4|54.4||significance of 0.05 or alpha of 0.05.|ANCOVA|Fixed effects of sequence, period and treatment; a random effect of subject within sequence; and a covariate of period-specific baseline FEV1.|FS MDPI 100/12.5 mcg - Advair Diskus 100/50 mcg|The estimated treatment difference from the ANCOVA model between each FS MDPI 100/12.5 mcg dose group and Advair Diskus 100/50 mcg group is presented together with the two-sided 95% CI for the difference and the p-value.||54.4|-54.4|0.9993
72411462|NCT04666441|144331365|SUPERIORITY||Difference of LS Means|-0.57|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-0.82|-0.33|||ANCOVA|||Baseline Viral Load \>10\^4 copies/mL Difference vs. Placebo (log10 copies/mL)||-0.33|-0.82|<0.0001
72411463|NCT04666441|144331365|SUPERIORITY||Difference of LS Means|-0.65|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-0.9|-0.4|||ANCOVA|||Baseline Viral Load \>10\^5 copies/mL Difference vs. Placebo (log10 copies/mL)||-0.40|-0.90|<0.0001
72411464|NCT04666441|144331365|SUPERIORITY||Difference of LS Means|-0.7|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-0.97|-0.42|||ANCOVA|||Baseline Viral Load \>10\^6 copies/mL Difference vs. Placebo (log10 copies/mL)||-0.42|-0.97|<0.0001
72411465|NCT04666441|144331365|SUPERIORITY||Difference of LS Means|-0.88|STANDARD_ERROR_OF_MEAN|0.16|<|0.0001|TWO_SIDED|95.0|-1.19|-0.58|||ANCOVA|||Baseline Viral Load \>10\^7 copies/mL Difference vs. Placebo (log10 copies/mL)||-0.58|-1.19|<0.0001
72411466|NCT04666441|144331365|SUPERIORITY||Difference of LS Means|-0.58|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-0.84|-0.33|||ANCOVA|||Baseline Viral Load \>10\^4 copies/mL Difference vs. Placebo (log10 copies/mL)||-0.33|-0.84|<0.0001
72411467|NCT04666441|144331365|SUPERIORITY||Difference of LS Means|-0.69|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-0.95|-0.43|||ANCOVA|||Baseline Viral Load \>10\^5 copies/mL Difference vs. Placebo (log10 copies/mL)||-0.43|-0.95|<0.0001
72411468|NCT04666441|144331365|SUPERIORITY||Difference of LS Means|-0.71|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-0.98|-0.44|||ANCOVA|||Baseline Viral Load \>10\^6 copies/mL Difference vs. Placebo (log10 copies/mL)||-0.44|-0.98|<0.0001
72411469|NCT04666441|144331365|SUPERIORITY||Difference of LS Means|-0.95|STANDARD_ERROR_OF_MEAN|0.16|<|0.0001|TWO_SIDED|95.0|-1.25|-0.64|||ANCOVA|||Baseline Viral Load \>10\^7 copies/mL Difference vs. Placebo (log10 copies/mL)||-0.64|-1.25|<0.0001
72411470|NCT04666441|144331365|SUPERIORITY||Difference of LS Means|-0.62|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-0.87|-0.37|||ANCOVA|||Baseline Viral Load \>10\^4 copies/mL Difference vs. Placebo (log10 copies/mL)||-0.37|-0.87|<0.0001
72411471|NCT04666441|144331365|SUPERIORITY||Difference of LS Means|-0.67|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-0.93|-0.42|||ANCOVA|||Baseline Viral Load \>10\^5 copies/mL Difference vs. Placebo (log10 copies/mL)||-0.42|-0.93|<0.0001
72411472|NCT04666441|144331365|SUPERIORITY||Difference of LS Means|-0.72|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-0.99|-0.44|||ANCOVA|||Baseline Viral Load \>10\^6 copies/mL Difference vs. Placebo (log10 copies/mL)||-0.44|-0.99|<0.0001
72545001|NCT01772368|144619130|SUPERIORITY||LSM difference|-42.05||||0.1311|TWO_SIDED|95.0|-96.7|12.6||significance of 0.05 or alpha of 0.05.|ANCOVA|Fixed effects of sequence, period and treatment; a random effect of subject within sequence; and a covariate of period-specific baseline FEV1.|FS MDPI 100/6.25 mcg - Advair Diskus 100/50 mcg|The estimated treatment difference from the ANCOVA model between each FS MDPI 100/6.25 mcg dose group and Advair Diskus 100/50 mcg group is presented together with the two-sided 95% CI for the difference and the p-value.||12.6|-96.7|0.1311
72545002|NCT01772368|144619130|SUPERIORITY||LSM difference|-159.01|||<|0.0001|TWO_SIDED|95.0|-213.7|-104.3||significance of 0.05 or alpha of 0.05.|ANCOVA|Fixed effects of sequence, period and treatment; a random effect of subject within sequence; and a covariate of period-specific baseline FEV1.|Fp MDPI 100 mcg - Advair Diskus 100/50 mcg|The estimated treatment difference from the ANCOVA model between each Fp MDPI 100 mcg dose group and Advair Diskus 100/50 mcg group is presented together with the two-sided 95% CI for the difference and the p-value.||-104.3|-213.7|<0.0001
72545003|NCT01772368|144619131|SUPERIORITY||geometric mean ratio|1.929|||||TWO_SIDED|90.0|1.69|2.202||||||The analysis is based on ANOVA model of the log transformed data, with fixed effects of sequence, period and treatment, and a random effect for subject within sequence. n=58||2.202|1.690|
72545004|NCT01772368|144619131|SUPERIORITY||geometric mean ratio|0.8|||||TWO_SIDED|90.0|0.702|0.911||||||The analysis is based on ANOVA model of the log transformed data, with fixed effects of sequence, period and treatment, and a random effect for subject within sequence. n=59||0.911|0.702|
72545005|NCT01772368|144619131|SUPERIORITY||geometric mean ratio|0.427|||||TWO_SIDED|90.0|0.376|0.485||||||The analysis is based on ANOVA model of the log transformed data, with fixed effects of sequence, period and treatment, and a random effect for subject within sequence. n=61||0.485|0.376|
72545006|NCT01772368|144619131|SUPERIORITY||LSM difference|0.172|||||TWO_SIDED|90.0|0.151|0.196||||||The analysis is based on ANOVA model of the log transformed data, with fixed effects of sequence, period and treatment, and a random effect for subject within sequence. n=59||0.196|0.151|
72545007|NCT01772368|144619132|SUPERIORITY||geometric mean ratio|3.622|||||TWO_SIDED|90.0|3.149|4.168||||||The analysis is based on ANOVA model of the log transformed data, with fixed effects of sequence, period and treatment, and a random effect for subject within sequence. n=58||4.168|3.149|
72411473|NCT04666441|144331365|SUPERIORITY||Difference of LS Means|-0.93|STANDARD_ERROR_OF_MEAN|0.16|<|0.0001|TWO_SIDED|95.0|-1.25|-0.61|||ANCOVA|||Baseline Viral Load \>10\^7 copies/mL Difference vs. Placebo (log10 copies/mL)||-0.61|-1.25|<0.0001
72411474|NCT04666441|144331365|SUPERIORITY||Difference of LS Means|-0.56|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-0.8|-0.31|||ANCOVA|||Baseline Viral Load \>10\^4 copies/mL Difference vs. Placebo (log10 copies/mL)||-0.31|-0.80|<0.0001
72411475|NCT04666441|144331365|SUPERIORITY||Difference of LS Means|-0.64|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-0.89|-0.38|||ANCOVA|||Baseline Viral Load \>10\^5 copies/mL Difference vs. Placebo (log10 copies/mL)||-0.38|-0.89|<0.0001
72411476|NCT04666441|144331365|SUPERIORITY||Difference of LS Means|-0.7|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-0.97|-0.43|||ANCOVA|||Baseline Viral Load \>10\^6 copies/mL Difference vs. Placebo (log10 copies/mL)||-0.43|-0.97|<0.0001
72411477|NCT04666441|144331365|SUPERIORITY||Difference of LS Means|-0.84|STANDARD_ERROR_OF_MEAN|0.16|<|0.0001|TWO_SIDED|95.0|-1.15|-0.52|||ANCOVA|||Baseline Viral Load \>10\^7 copies/mL Difference vs. Placebo (log10 copies/mL)||-0.52|-1.15|<0.0001
72411478|NCT04666441|144331365|SUPERIORITY||Difference of LS Means|-0.51|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-0.76|-0.27|||ANCOVA|||Baseline Viral Load \>10\^4 copies/mL Difference vs. Placebo (log10 copies/mL)||-0.27|-0.76|<0.0001
72545008|NCT01772368|144619132|SUPERIORITY||geometric mean ratio|1.534|||||TWO_SIDED|90.0|1.335|1.763||||||The analysis is based on ANOVA model of the log transformed data, with fixed effects of sequence, period and treatment, and a random effect for subject within sequence. n=59||1.763|1.335|
72545009|NCT01772368|144619132|SUPERIORITY||geometric mean ratio|0.795|||||TWO_SIDED|90.0|0.694|0.911||||||The analysis is based on ANOVA model of the log transformed data, with fixed effects of sequence, period and treatment, and a random effect for subject within sequence. n=61||0.911|0.694|
72545010|NCT01772368|144619132|SUPERIORITY||geometric mean ratio|0.339|||||TWO_SIDED|90.0|0.295|0.39||||||The analysis is based on ANOVA model of the log transformed data, with fixed effects of sequence, period and treatment, and a random effect for subject within sequence. n=59||0.390|0.295|
72579566|NCT02448368|144687966|NON_INFERIORITY_OR_EQUIVALENCE|The sample size is not based on formal power calculations, as this study is designed only to provide an initial assessment of the PK, PD, and safety profile of RDEA3170.|Geometric Least Squares mean Ratio|104.0|||||TWO_SIDED|90.0|95.0|113.0|||Mixed Models Analysis|A mixed effect model on the natural log-transformed PK parameters Cmax, AUClast, and AUC∞ with fixed effect for treatment.||||113|95.0|
72579567|NCT02448368|144687966|NON_INFERIORITY_OR_EQUIVALENCE|The sample size is not based on formal power calculations, as this study is designed only to provide an initial assessment of the PK, PD, and safety profile of RDEA3170|Geometric Least Squares mean Ratio|115.0|||||TWO_SIDED|90.0|95.3|140.0|||Mixed Models Analysis|A mixed effect model on the natural log-transformed PK parameters Cmax, AUClast, and AUC∞ with fixed effect for treatment.||||140|95.3|
72579568|NCT02448368|144687967|NON_INFERIORITY_OR_EQUIVALENCE|The sample size is not based on formal power calculations, as this study is designed only to provide an initial assessment of the PK, PD, and safety profile of RDEA3170|Geometric Least Squares mean Ratio|107.0|||||TWO_SIDED|90.0|98.1|116.0|||Mixed Models Analysis|A mixed effect model on the natural log-transformed PK parameters Cmax, AUClast, and AUC∞ with fixed effect for treatment.||||116|98.1|
72579569|NCT02448368|144687967|NON_INFERIORITY_OR_EQUIVALENCE|The sample size is not based on formal power calculations, as this study is designed only to provide an initial assessment of the PK, PD, and safety profile of RDEA3170|Geometric Least Squares mean Ratio|103.0|||||TWO_SIDED|90.0|94.6|113.0|||Mixed Models Analysis|A mixed effect model on the natural log-transformed PK parameters Cmax, AUClast, and AUC∞ with fixed effect for treatment.||||113|94.6|
72579570|NCT02448368|144687967|NON_INFERIORITY_OR_EQUIVALENCE|The sample size is not based on formal power calculations, as this study is designed only to provide an initial assessment of the PK, PD, and safety profile of RDEA3170|Geometric Least Squares mean Ratio|113.0|||||TWO_SIDED|90.0|93.3|137.0|||Mixed Models Analysis|A mixed effect model on the natural log-transformed PK parameters Cmax, AUClast, and AUC∞ with fixed effect for treatment.||||137|93.3|
72579571|NCT02890355|144688007|SUPERIORITY||Hazard Ratio (HR)|1.23||||0.28|TWO_SIDED|95.0|0.85|1.78||a priori threshold for statistical significance, one sided p=0.02|Log Rank|||||1.78|0.85|0.28
72579572|NCT02890355|144688009|SUPERIORITY||Hazard Ratio (HR)|1.39||||0.09|TWO_SIDED|95.0|0.96|2.02|||Log Rank|||||2.02|0.96|0.09
72579573|NCT01128179|144688016|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.1121||||0.3186|TWO_SIDED|95.0|-0.3389|0.1146||The a priori significance level was 5%. There was no adjustment for multiple comparisons.|ANCOVA|||Assuming that the natural logarithm transformed serum intact FGF-23 is normally distributed with a mean of 3.5 and a standard deviation of 0.46, 33 subjects randomised 2:1 (lanthanum carbonate to placebo) will be sufficient to detect with 80% power at the 5% 2-sided significance level a decrease of 0.5 in the mean difference (placebo minus lanthanum carbonate) of the log-transformed data at Week 12.||0.1146|-0.3389|0.3186
72579574|NCT01128179|144688017|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|6.54||||0.2995|TWO_SIDED|95.0|-6.15|19.23||The p-value was unadjusted and had no a priori significance level.|ANCOVA|||The null hypothesis was that there would be no difference between the 2 treatment groups in the mean change from baseline of serum iPTH at Week 12 (LOCF) in an analysis of covariance (ANCOVA) with treatment as a factor and the baseline iPTH as a covariate. The study was not powered for the analysis of this parameter.||19.23|-6.15|0.2995
72579575|NCT01128179|144688018|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.11||||0.3252|TWO_SIDED|95.0|-5.36|15.57||The p-value was unadjusted and had no a priori significance level.|ANCOVA|||The null hypothesis was that there would be no difference between the 2 treatment groups in the mean change from baseline of 1,25-Dihydroxy Vitamin D at Week 12 (LOCF) when utilizing an analysis of covariance (ANCOVA) with treatment as a factor and the baseline 1,25-Dihydroxy Vitamin D as a covariate. The study was not powered for the analysis of this parameter.||15.57|-5.36|0.3252
72579576|NCT01128179|144688019|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.7||||0.1459|TWO_SIDED|95.0|-8.845|1.403||The p-value was unadjusted and had no a priori significance level.|ANCOVA|||The null hypothesis was that there would be no difference between the 2 treatment groups in the mean change from baseline of Urinary Fractional Excretion of Phosphate at Week 12 (LOCF) when utilizing an analysis of covariance (ANCOVA) with treatment as a factor and the baseline Urinary Fractional Excretion of Phosphate as a covariate. The study was not powered for the analysis of this parameter.||1.403|-8.845|0.1459
72579577|NCT01128179|144688020|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.0297||||0.6134|TWO_SIDED|95.0|-0.1492|0.0897||The p-value was unadjusted and had no a priori significance level.|ANCOVA|||The null hypothesis was that there would be no difference between the 2 treatment groups in the mean change from baseline of Serum Phosphate at Week 12 (LOCF) in an analysis of covariance (ANCOVA) with treatment as a factor and the baseline Serum Phosphate as a covariate. The study was not powered for the analysis of this parameter||0.0897|-0.1492|0.6134
72545011|NCT02449291|144619140|SUPERIORITY|||||||0.016|ONE_SIDED|95.0||||One-sided p-value. After adjustment for multiplicity using Hommel's method. (Note: unadjusted p value = 0.016) A priori threshold for statistical significance = 0.025.|Chi-squared|||The primary efficacy analysis was a comparison of the incidence of the primary efficacy variable between the two groups that received APD421 and the group that received placebo, using Pearson's χ2 test. The threshold for determining statistical significance in the comparison of incidence of success between the active and placebo groups (the primary efficacy analysis) was a p-value of 2.5% one-sided.||||0.016
72411479|NCT04666441|144331365|SUPERIORITY||Difference of LS Means|-0.58|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-0.83|-0.33|||ANCOVA|||Baseline Viral Load \>10\^5 copies/mL Difference vs. Placebo (log10 copies/mL)||-0.33|-0.83|<0.0001
72411480|NCT04666441|144331365|SUPERIORITY||Difference of LS Means|-0.55|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-0.82|-0.28|||ANCOVA|||Baseline Viral Load \>10\^6 copies/mL Difference vs. Placebo (log10 copies/mL)||-0.28|-0.82|<0.0001
72411481|NCT04666441|144331365|SUPERIORITY||Difference of LS Means|-0.63|STANDARD_ERROR_OF_MEAN|0.16|<|0.0001|TWO_SIDED|95.0|-0.95|-0.32|||ANCOVA|||Baseline Viral Load \>10\^7 copies/mL Difference vs. Placebo (log10 copies/mL)||-0.32|-0.95|<0.0001
72411482|NCT04666441|144331365|SUPERIORITY||Difference of LS Means|-0.48|STANDARD_ERROR_OF_MEAN|0.13||0.0002|TWO_SIDED|95.0|-0.73|-0.23|||ANCOVA|||Baseline Viral Load \>10\^4 copies/mL Difference vs. Placebo (log10 copies/mL)||-0.23|-0.73|0.0002
72411483|NCT04666441|144331365|SUPERIORITY||Difference of LS Means|-0.56|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-0.82|-0.31|||ANCOVA|||Baseline Viral Load \>10\^5 copies/mL Difference vs. Placebo (log10 copies/mL)||-0.31|-0.82|<0.0001
72411484|NCT04666441|144331365|SUPERIORITY||Difference of LS Means|-0.6|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-0.87|-0.33|||ANCOVA|||Baseline Viral Load \>10\^6 copies/mL Difference vs. Placebo (log10 copies/mL)||-0.33|-0.87|<0.0001
72411485|NCT04666441|144331365|SUPERIORITY||Difference of LS Means|-0.84|STANDARD_ERROR_OF_MEAN|0.16|<|0.0001|TWO_SIDED|95.0|-1.16|-0.52|||ANCOVA|||Baseline Viral Load \>10\^7 copies/mL Difference vs. Placebo (log10 copies/mL)||-0.52|-1.16|<0.0001
72411486|NCT04666441|144331366|SUPERIORITY||Difference of LS Means|-0.41|STANDARD_ERROR_OF_MEAN|0.12||0.0005|TWO_SIDED|95.0|-0.64|-0.18|||ANCOVA|||Baseline Viral Load \>10\^4 copies/mL Difference vs. Placebo (log10 copies/mL)||-0.18|-0.64|0.0005
72411487|NCT04666441|144331366|SUPERIORITY||Difference of LS Means|-0.46|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-0.69|-0.23|||ANCOVA|||Baseline Viral Load \>10\^5 copies/mL Difference vs. Placebo (log10 copies/mL)||-0.23|-0.69|<0.0001
72545012|NCT02449291|144619140|SUPERIORITY|||||||0.016||||||One-sided p-value. After adjustment for multiplicity using Hommel's method. (Note: unadjusted p value = 0.015) A priori threshold for statistical significance = 0.025.|Chi-squared|||The primary efficacy analysis was a comparison of the incidence of the primary efficacy variable between the two groups that received APD421 and the group that received placebo, using Pearson's χ2 test. The threshold for determining statistical significance in the comparison of incidence of success between the active and placebo groups (the primary efficacy analysis) was a p-value of 2.5% one-sided.||||0.016
72545013|NCT02449291|144619141|SUPERIORITY|||||||0.009||||||One-sided p-value. No adjustment for multiple comparisons. A priori threshold for statistical significance = 0.025.|Chi-squared|||||||0.009
72545014|NCT02449291|144619141|SUPERIORITY|||||||0.002||||||One-sided p-value. No adjustment for multiple comparisons. A priori threshold for statistical significance = 0.025.|Chi-squared|||||||0.002
72411488|NCT04666441|144331366|SUPERIORITY||Difference of LS Means|-0.51|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-0.75|-0.26|||ANCOVA|||Baseline Viral Load \>10\^6 copies/mL Difference vs. Placebo (log10 copies/mL)||-0.26|-0.75|<0.0001
72411489|NCT04666441|144331366|SUPERIORITY||Difference of LS Means|-0.6|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-0.88|-0.32|||ANCOVA|||Baseline Viral Load \>10\^7 copies/mL Difference vs. Placebo (log10 copies/mL)||-0.32|-0.88|<0.0001
72411490|NCT04666441|144331366|SUPERIORITY||Difference of LS Means|-0.45|STANDARD_ERROR_OF_MEAN|0.12||0.0003|TWO_SIDED|95.0|-0.69|-0.21|||ANCOVA|||Baseline Viral Load \>10\^4 copies/mL Difference vs. Placebo (log10 copies/mL)||-0.21|-0.69|0.0003
72411491|NCT04666441|144331366|SUPERIORITY||Difference of LS Means|-0.53|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-0.77|-0.29|||ANCOVA|||Baseline Viral Load \>10\^5 copies/mL Difference vs. Placebo (log10 copies/mL)||-0.29|-0.77|<0.0001
72411492|NCT04666441|144331366|SUPERIORITY||Difference of LS Means|-0.53|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-0.78|-0.29|||ANCOVA|||Baseline Viral Load \>10\^6 copies/mL Difference vs. Placebo (log10 copies/mL)||-0.29|-0.78|<0.0001
72411493|NCT04666441|144331366|SUPERIORITY||Difference of LS Means|-0.69|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-0.98|-0.41|||ANCOVA|||Baseline Viral Load \>10\^7 copies/mL Difference vs. Placebo (log10 copies/mL)||-0.41|-0.98|<0.0001
72411494|NCT04666441|144331366|SUPERIORITY||Difference of LS Means|-0.48|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-0.72|-0.25|||ANCOVA|||Baseline Viral Load \>10\^4 copies/mL Difference vs. Placebo (log10 copies/mL)||-0.25|-0.72|<0.0001
72411495|NCT04666441|144331366|SUPERIORITY||Difference of LS Means|-0.51|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-0.74|-0.28|||ANCOVA|||Baseline Viral Load \>10\^5 copies/mL Difference vs. Placebo (log10 copies/mL)||-0.28|-0.74|<0.0001
72411496|NCT04666441|144331366|SUPERIORITY||Difference of LS Means|-0.54|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-0.79|-0.3|||ANCOVA|||Baseline Viral Load \>10\^6 copies/mL Difference vs. Placebo (log10 copies/mL)||-0.30|-0.79|<0.0001
72411497|NCT04666441|144331366|SUPERIORITY||Difference of LS Means|-0.7|STANDARD_ERROR_OF_MEAN|0.15|<|0.0001|TWO_SIDED|95.0|-0.99|-0.4|||ANCOVA|||Baseline Viral Load \>10\^7 copies/mL Difference vs. Placebo (log10 copies/mL)||-0.40|-0.99|<0.0001
72411498|NCT04666441|144331366|SUPERIORITY||Difference of LS Means|-0.39|STANDARD_ERROR_OF_MEAN|0.12||0.0009|TWO_SIDED|95.0|-0.63|-0.16|||ANCOVA|||Baseline Viral Load \>10\^4 copies/mL Difference vs. Placebo (log10 copies/mL)||-0.16|-0.63|0.0009
72545015|NCT02449291|144619142|SUPERIORITY|||||||0.17||||||One-sided p-value. No adjustment for multiple comparisons. A priori threshold for statistical significance = 0.025.|Chi-squared|||||||0.170
72545016|NCT02449291|144619142|SUPERIORITY|||||||0.552||||||One-sided p-value. No adjustment for multiple comparisons. A priori threshold for statistical significance = 0.025.|Chi-squared|||||||0.552
72545017|NCT02449291|144619143|SUPERIORITY|||||||0.003|||||||Regression, Cox|||||||0.003
72545018|NCT02449291|144619143|SUPERIORITY||||||<|0.001|||||||Regression, Cox|||||||<0.001
72545019|NCT02449291|144619144|SUPERIORITY|||||||0.209|||||||Chi-squared|||||||0.209
72545020|NCT02449291|144619144|SUPERIORITY|||||||0.44|||||||Chi-squared|||||||0.440
72545021|NCT02449291|144619145|SUPERIORITY|||||||0.009|||||||Chi-squared|||||||0.009
72545022|NCT02449291|144619145|SUPERIORITY|||||||0.009|||||||Chi-squared|||||||0.009
72545023|NCT02449291|144619146|SUPERIORITY|||||||0.115|||||||Chi-squared|||||||0.115
72545024|NCT02449291|144619146|SUPERIORITY|||||||0.222|||||||Chi-squared|||||||0.222
72545025|NCT02449291|144619147|SUPERIORITY|||||||0.474|||||||Chi-squared|||||||0.474
72545026|NCT02449291|144619147|SUPERIORITY|||||||0.505|||||||Chi-squared|||||||0.505
72411499|NCT04666441|144331366|SUPERIORITY||Difference of LS Means|-0.46|STANDARD_ERROR_OF_MEAN|0.12||0.0001|TWO_SIDED|95.0|-0.69|-0.23|||ANCOVA|||Baseline Viral Load \>10\^5 copies/mL Difference vs. Placebo (log10 copies/mL)||-0.23|-0.69|0.0001
72411500|NCT04666441|144331366|SUPERIORITY||Difference of LS Means|-0.52|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-0.77|-0.27|||ANCOVA|||Baseline Viral Load \>10\^6 copies/mL Difference vs. Placebo (log10 copies/mL)||-0.27|-0.77|<0.0001
72411501|NCT04666441|144331366|SUPERIORITY||Difference of LS Means|-0.63|STANDARD_ERROR_OF_MEAN|0.15|<|0.0001|TWO_SIDED|95.0|-0.92|-0.34|||ANCOVA|||Baseline Viral Load \>10\^7 copies/mL Difference vs. Placebo (log10 copies/mL)||-0.34|-0.92|<0.0001
72411502|NCT04666441|144331366|SUPERIORITY||Difference of LS Means|-0.34|STANDARD_ERROR_OF_MEAN|0.12||0.0046|TWO_SIDED|95.0|-0.57|-0.1|||ANCOVA|||Baseline Viral Load \>10\^4 copies/mL Difference vs. Placebo (log10 copies/mL)||-0.10|-0.57|0.0046
72411503|NCT04666441|144331366|SUPERIORITY||Difference of LS Means|-0.39|STANDARD_ERROR_OF_MEAN|0.12||0.0011|TWO_SIDED|95.0|-0.62|-0.15|||ANCOVA|||Baseline Viral Load \>10\^5 copies/mL Difference vs. Placebo (log10 copies/mL)||-0.15|-0.62|0.0011
72545027|NCT02449291|144619148|SUPERIORITY|||||||0.103|||||||Wilcoxon (Mann-Whitney)|||||||0.103
72545028|NCT02449291|144619148|SUPERIORITY|||||||0.166|||||||Wilcoxon (Mann-Whitney)|||||||0.166
72545029|NCT02449291|144619149|SUPERIORITY|||||||0.06|||||||Wilcoxon (Mann-Whitney)|||||||0.06
72545030|NCT02449291|144619149|SUPERIORITY|||||||0.029|||||||Wilcoxon (Mann-Whitney)|||||||0.029
72545031|NCT03551730|144619150|SUPERIORITY||Least Squares Means (Difference)|-0.23|||<|0.0001|TWO_SIDED||||||ANCOVA|||||||<0.0001
72545032|NCT03551730|144619150|SUPERIORITY||Least Squares Means (Difference)|-0.2|||<|0.0001|TWO_SIDED||||||ANCOVA|||||||<0.0001
72545033|NCT03551730|144619150|SUPERIORITY||Least Squares Means (Difference)|-0.23|||<|0.0001|TWO_SIDED||||||ANCOVA|||||||<0.0001
72545034|NCT03551730|144619151|SUPERIORITY||Least Squares Means (Difference)|53922.58||||0.1529|TWO_SIDED||||||ANCOVA|||||||0.1529
72545035|NCT03551730|144619151|SUPERIORITY||Least Squares Means (Difference)|124993.1|||<|0.0001|TWO_SIDED||||||ANCOVA|||||||<0.0001
72579578|NCT01128179|144688021|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0294||||0.5636|TWO_SIDED|95.0|-0.0739|0.1328||The p-value was unadjusted and had no a priori significance level.|ANCOVA|||The null hypothesis was that there would be no difference between the 2 treatment groups in the mean change from baseline of Serum Total Calcium at Week 12 (LOCF) in an analysis of covariance (ANCOVA) with treatment as a factor and the baseline Serum Total Calcium as a covariate. The study was not powered for the analysis of this parameter.||0.1328|-0.0739|0.5636
72545036|NCT03551730|144619151|SUPERIORITY||Least Squares Means (Difference)|96385.09||||0.0032|TWO_SIDED||||||ANCOVA|||||||0.0032
72545037|NCT02363010|144619158|SUPERIORITY|||||||0.68||||||A prior threshold for statistical significance was p \< .05.|ANOVA|Controlling for baseline weight.||Exploring group differences in 12 month weight losses.||||.68
72545038|NCT02363010|144619158|SUPERIORITY|||||||0.11||||||A prior threshold for significance was p\<.05.|ANOVA|Controlling for baseline weight.||Exploring group differences in 18 month weight losses.||||.11
72545039|NCT02363010|144619159|SUPERIORITY|||||||0.41||||||A priori threshold for statistical significance was p \< .05.|Compound Poisson general linear models|Controlling for baseline MVPA.||Exploring group differences in 12 month moderator to vigorous physical activity (MVPA).||||.41
72545040|NCT02363010|144619159|SUPERIORITY|||||||0.46||||||A priori threshold for statistical significance was p \< .05.|Compound Poisson general linear models|Controlling for baseline MVPA.||Exploring group differences in 12 month MVPA.||||.46
72545041|NCT02363010|144619159|SUPERIORITY|||||||0.82||||||A priori threshold for statistical significance was p\< .05.|Compound Poisson general linear models|Controlling for baseline MVPA.||Exploring group differences in 12 month MVPA.||||.82
72545042|NCT02363010|144619159|SUPERIORITY|||||||0.42||||||A priori threshold for statistical significance was p \< .05.|Compound Poisson general linear models|Controlling for baseline MVPA.||Exploring group differences in 18 month MVPA.||||.42
72545043|NCT02363010|144619159|SUPERIORITY|||||||0.28||||||A priori threshold for statistical significance was p \< .05.|Compound Poisson general linear models|Controlling for baseline MVPA.||Exploring group differences in 18 month MVPA.||||.28
72545044|NCT02363010|144619159|SUPERIORITY|||||||0.82||||||A priori threshold for statistical significance was p \< .05.|Compound Poisson general linear models|Controlling for baseline MVPA.||Exploring group differences in 18 month MVPA.||||.82
72545045|NCT02363010|144619160|SUPERIORITY|||||||0.06||||||A priori threshold for statistical significance was p \< .05.|ANOVA|Controlling for baseline half-mile walk time.||Exploring group differences in 12 month cardiorespiratory fitness, measured by half-mile walk time.||||.06
72545046|NCT02363010|144619160|SUPERIORITY|||||||0.3||||||A priori threshold for statistical significance was p \< .05.|ANOVA|Controlling for baseline half-mile walk time.||Exploring group differences in 18 month cardiorespiratory fitness, measured by half-mile walk time.||||.30
72545047|NCT02363010|144619161|SUPERIORITY|||||||0.59||||||A priori threshold for statistical significance was p \< .05.|ANOVA|Controlling for baseline waist circumference.||Exploring group differences in 12 month waist circumference.||||.59
72545048|NCT02363010|144619161|SUPERIORITY|||||||0.57||||||A priori threshold for statistical significance was p \< .05.|ANOVA|Controlling for baseline waist circumference.||Exploring group differences in 18 month waist circumference.||||.57
72545049|NCT02363010|144619162|SUPERIORITY|||||||0.978||||||A priori threshold for statistical significance was p \< .05.|Regression, Linear|Controlling for baseline weight.||The null hypothesis was that baseline Emotional Overeating would not significantly moderate the relationship between the three treatment conditions and 36-month weight loss. As a note, multiple imputation for missing weight loss data was not conducted for exploratory moderation analyses.||||.978
72545050|NCT02363010|144619162|SUPERIORITY|||||||0.998||||||A priori threshold for statistical significance was p \<.05.|Regression, Poison|Controlling for baseline MVPA. Poisson linear regression was used as MVPA data distribution was zero-inflated.||The null hypothesis was that baseline Emotional Overeating would not significantly moderate the relationship between the three treatment conditions and 36-month MVPA. As a note, multiple imputation for missing MVPA data was not conducted for exploratory moderation analyses.||||.998
72545051|NCT02363010|144619162|SUPERIORITY|||||||0.878||||||A priori threshold for statistical significance was p \< .05.|Regression, Linear|Controlling for baseline weight.||The null hypothesis was that 6-month Emotional Overeating would not significantly moderate the relationship between the three treatment conditions and 36-month weight loss. As a note, multiple imputation for missing weight loss data was not conducted for exploratory moderation analyses.||||.878
72545052|NCT02363010|144619162|SUPERIORITY|||||||0.602||||||A priori threshold for statistical significance was p \< .05.|Regression, Poison|Controlling for baseline MVPA. Poisson linear regression was used as MVPA data distribution was zero-inflated.||The null hypothesis was that 6-month Emotional Overeating would not significantly moderate the relationship between the three treatment conditions and 36-month MVPA. As a note, multiple imputation for missing MVPA data was not conducted for exploratory moderation analyses.||||.602
72545053|NCT02363010|144619163|SUPERIORITY|||||||0.487||||||A prior threshold for statistical significance was p \< .05.|Regression, Linear|Controlling for baseline weight.||The null hypothesis was that baseline Disinhibited Eating would not significantly moderate the relationship between the three treatment conditions and 36-month weight loss. As a note, multiple imputation for missing weight loss data was not conducted for exploratory moderation analyses.||||.487
72411504|NCT04666441|144331366|SUPERIORITY||Difference of LS Means|-0.37|STANDARD_ERROR_OF_MEAN|0.13||0.0029|TWO_SIDED|95.0|-0.62|-0.13|||ANCOVA|||Baseline Viral Load \>10\^6 copies/mL Difference vs. Placebo (log10 copies/mL)||-0.13|-0.62|0.0029
72545054|NCT02363010|144619163|SUPERIORITY|||||||0.262||||||A prior threshold for statistical significance was p \< .05.|Regression, Poison|Controlling for baseline MVPA. Poisson linear regression was used as MVPA data distribution was zero-inflated.||The null hypothesis was that baseline Disinhibited Eating would not significantly moderate the relationship between the three treatment conditions and 36-month MVPA. As a note, multiple imputation for missing MVPA data was not conducted for exploratory moderation analyses.||||.262
72411505|NCT04666441|144331366|SUPERIORITY||Difference of LS Means|-0.37|STANDARD_ERROR_OF_MEAN|0.15||0.012|TWO_SIDED|95.0|-0.66|-0.08|||ANCOVA|||Baseline Viral Load \>10\^7 copies/mL Difference vs. Placebo (log10 copies/mL)||-0.08|-0.66|0.0120
72545055|NCT02363010|144619163|SUPERIORITY|||||||0.851||||||A prior threshold for statistical significance was p \< .05.|Regression, Linear|Controlling for baseline weight.||The null hypothesis was that 6-month Disinhibited Eating would not significantly moderate the relationship between the three treatment conditions and 36-month weight loss. As a note, multiple imputation for missing weight loss data was not conducted for exploratory moderation analyses.||||.851
72545056|NCT02363010|144619163|SUPERIORITY|||||||0.978||||||A prior threshold for statistical significance was p \< .05.|Regression, Poison|Controlling for baseline MVPA. Poisson linear regression was used as MVPA data distribution was zero-inflated.||The null hypothesis was that 6-month Disinhibited Eating would not significantly moderate the relationship between the three treatment conditions and 36-month MVPA. As a note, multiple imputation for missing MVPA data was not conducted for exploratory moderation analyses.||||.978
72545057|NCT02363010|144619164|SUPERIORITY|||||||0.796||||||A prior threshold for statistical significance was p \< .05.|Regression, Linear|Controlling for baseline weight.||The null hypothesis was that baseline Hedonic Hunger would not significantly moderate the relationship between the three treatment conditions and 36-month weight loss. As a note, multiple imputation for missing weight loss data was not conducted for exploratory moderation analyses.||||.796
72545058|NCT02363010|144619164|SUPERIORITY|||||||0.481||||||A prior threshold for statistical significance was p \< .05.|Regression, Poison|Controlling for baseline MVPA. Poisson linear regression was used as MVPA data distribution was zero-inflated.||The null hypothesis was that baseline Hedonic Hunger would not significantly moderate the relationship between the three treatment conditions and 36-month MVPA. As a note, multiple imputation for missing MVPA data was not conducted for exploratory moderation analyses.||||.481
72545059|NCT02363010|144619164|SUPERIORITY|||||||0.872||||||A prior threshold for statistical significance was p \< .05.|Regression, Linear|Controlling for baseline weight.||The null hypothesis was that 6-month Hedonic Hunger would not significantly moderate the relationship between the three treatment conditions and 36-month weight loss. As a note, multiple imputation for missing weight loss data was not conducted for exploratory moderation analyses.||||.872
72545060|NCT02363010|144619164|SUPERIORITY|||||||0.802||||||A prior threshold for statistical significance was p \< .05.|Regression, Poison|Controlling for baseline MVPA. Poisson linear regression was used as MVPA data distribution was zero-inflated.||The null hypothesis was that 6-month Hedonic Hunger would not significantly moderate the relationship between the three treatment conditions and 36-month weight loss. As a note, multiple imputation for missing weight loss data was not conducted for exploratory moderation analyses.||||.802
72545061|NCT02363010|144619165|SUPERIORITY|||||||0.926||||||A prior threshold for statistical significance was p \< .05.|Regression, Linear|Controlling for baseline weight.||The null hypothesis was that baseline Appetitive Response to Exercise would not significantly moderate the relationship between the three treatment conditions and 36-month weight loss. As a note, multiple imputation for missing weight loss data was not conducted for exploratory moderation analyses.||||.926
72545062|NCT02363010|144619165|SUPERIORITY|||||||0.82||||||A prior threshold for statistical significance was p \< .05.|Regression, Poison|Controlling for baseline MVPA. Poisson linear regression was used as MVPA data distribution was zero-inflated.||The null hypothesis was that baseline Appetitive Response to Exercise would not significantly moderate the relationship between the three treatment conditions and 36-month MVPA. As a note, multiple imputation for missing MVPA data was not conducted for exploratory moderation analyses.||||.820
72545063|NCT02363010|144619165|SUPERIORITY|||||||0.127||||||A prior threshold for statistical significance was p \< .05.|Regression, Linear|Controlling for baseline weight.||The null hypothesis was that 6-month Appetitive Response to Exercise would not significantly moderate the relationship between the three treatment conditions and 36-month weight loss. As a note, multiple imputation for missing weight loss data was not conducted for exploratory moderation analyses.||||.127
72545064|NCT02363010|144619165|SUPERIORITY|||||||0.814||||||A prior threshold for statistical significance was p \< .05.|Regression, Poison|Controlling for baseline MVPA. Poisson linear regression was used as MVPA data distribution was zero-inflated.||The null hypothesis was that 6-month Appetitive Response to Exercise would not significantly moderate the relationship between the three treatment conditions and 36-month MVPA. As a note, multiple imputation for missing MVPA data was not conducted for exploratory moderation analyses.||||.814
72411506|NCT04666441|144331366|SUPERIORITY||Difference of LS Means|-0.33|STANDARD_ERROR_OF_MEAN|0.12||0.0062|TWO_SIDED|95.0|-0.56|-0.09|||ANCOVA|||Baseline Viral Load \>10\^4 copies/mL Difference vs. Placebo (log10 copies/mL)||-0.09|-0.56|0.0062
72545065|NCT04549259|144619181|SUPERIORITY||Odds Ratio (OR)|3.23||||0.33|TWO_SIDED|||||All tests performed were 2-sided. Given that the study was a pilot, we used α = .25 as a significance level cutoff and focus primarily on patterns in the data and effect sizes.|Mixed Models Analysis|||We fit a generalized linear mixed model using the glmer function and a logit link in the R package lme4. The model included a random effect for participant. Predictors (fixed effects) included time (baseline vs. follow-up), random assignments, and interactions between assignments and time. We adjusted for mode of survey completion. Significant interactions indicated differential changes in outcomes over time for those randomly assigned vs. not randomly assigned to different interventions.||||.33
72545066|NCT04549259|144619181|SUPERIORITY||Odds Ratio (OR)|1.76||||0.63|TWO_SIDED|||||All tests performed were 2-sided. Given that the study was a pilot, we used α = .25 as a significance level cutoff and focus primarily on patterns in the data and effect sizes.|Mixed Models Analysis|||We fit a generalized linear mixed model using the glmer function and a logit link in the R package lme4. The model included a random effect for participant. Predictors (fixed effects) included time (baseline vs. follow-up), random assignments, and interactions between assignments and time. We adjusted for mode of survey completion. Significant interactions indicated differential changes in outcomes over time for those randomly assigned vs. not randomly assigned to different interventions.||||.63
72545067|NCT04549259|144619181|SUPERIORITY||Odds Ratio (OR)|0.68||||0.78|TWO_SIDED|||||All tests performed were 2-sided. Given that the study was a pilot, we used α = .25 as a significance level cutoff and focus primarily on patterns in the data and effect sizes.|Mixed Models Analysis|||We fit a generalized linear mixed model using the glmer function and a logit link in the R package lme4. The model included a random effect for participant. Predictors (fixed effects) included time (baseline vs. follow-up), random assignments, and interactions between assignments and time. We adjusted for mode of survey completion. Significant interactions indicated differential changes in outcomes over time for those randomly assigned vs. not randomly assigned to different interventions.||||.78
72545068|NCT04549259|144619181|SUPERIORITY||Odds Ratio (OR)|0.87||||0.9|TWO_SIDED|||||All tests performed were 2-sided. Given that the study was a pilot, we used α = .25 as a significance level cutoff and focus primarily on patterns in the data and effect sizes.|Mixed Models Analysis|||We fit a generalized linear mixed model using the glmer function and a logit link in the R package lme4. The model included a random effect for participant. Predictors (fixed effects) included time (baseline vs. follow-up), random assignments, and interactions between assignments and time. We adjusted for mode of survey completion. Significant interactions indicated differential changes in outcomes over time for those randomly assigned vs. not randomly assigned to different interventions.||||.90
72579579|NCT01128179|144688022|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.0129||||0.922|TWO_SIDED|95.0|-0.2811|0.2553||The p-value was unadjusted and had no a priori significance level.|ANCOVA|||The null hypothesis was that there would be no difference between the 2 treatment groups in the mean change from baseline of Calcium-Phosphate Product at Week 12 (LOCF) in an analysis of covariance (ANCOVA) with treatment as a factor and the baseline Calcium-Phosphate Product as a covariate.||0.2553|-0.2811|0.9220
72579580|NCT01682811|144688023|OTHER|||||||0.0001|||||||t-test, 1 sided|||One-sample t-test comparing the absolute value to an alternate expected value of zero.||||0.0001
72579581|NCT01682811|144688026|OTHER|||||||0.24|||||||t-test, 2 sided|||Paired comparisons between treated and placebo lesions within subject.||||0.24
72579582|NCT01682811|144688029|OTHER|||||||0.002|||||||t-test, 2 sided|||||||0.002
72579583|NCT00720382|144688040|SUPERIORITY_OR_OTHER|||||||0.783||95.0|||||ANCOVA|ANCOVA was used as a model containing treatment group and site as fixed effects with the baseline value used as covariate||Overall baseline score||||0.783
72579584|NCT00720382|144688040|SUPERIORITY_OR_OTHER|||||||0.971|TWO_SIDED|95.0|||||ANCOVA|ANCOVA was used as a model containing treatment group and site as fixed effects with the baseline value used as covariate||Change from baseline to Month 1||||0.971
72579585|NCT00720382|144688040|SUPERIORITY_OR_OTHER|||||||0.206|TWO_SIDED|95.0|||||ANCOVA|ANCOVA was used as a model containing treatment group and site as fixed effects with the baseline value used as covariate||Change from baseline to Month 3||||0.206
72579586|NCT00720382|144688040|SUPERIORITY_OR_OTHER|||||||0.111||95.0|||||ANCOVA|ANCOVA was used as a model containing treatment group and site as fixed effects with the baseline value used as covariate||Change from baseline to Month 6||||0.111
72579587|NCT00720382|144688040|SUPERIORITY_OR_OTHER|||||||0.181||95.0|||||ANCOVA|ANCOVA was used as a model containing treatment group and site as fixed effects with the baseline value used as covariate||Change from baseline to Month 9||||0.181
72579588|NCT00720382|144688040|SUPERIORITY_OR_OTHER|||||||0.037|||||||ANCOVA|ANCOVA was used as a model containing treatment group and site as fixed effects with the baseline value used as covariate||Change from Baseline to Month 12/Early Term||||0.037
72579589|NCT03860974|144688047|NON_INFERIORITY|"We tested the non-inferiority of serratus block compared with PVB using the 95% CI associated with the Wilcoxon-Mann-Whitney test with continuity correction. If the lower limit of the 95% CI for median average PACU pain scores was greater than -1.25 , we would conclude non-inferiority. The non-inferiority of serratus blocks with regard to opioid consumption was similarly tested to a predefined non-inferiority margin of 2 mg intravenous morphine equivalents."|Median Difference (Final Values)|4.0||||0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.001
72411507|NCT04666441|144331366|SUPERIORITY||Difference of LS Means|-0.39|STANDARD_ERROR_OF_MEAN|0.12||0.0011|TWO_SIDED|95.0|-0.62|-0.16|||ANCOVA|||Baseline Viral Load \>10\^5 copies/mL Difference vs. Placebo (log10 copies/mL)||-0.16|-0.62|0.0011
72411508|NCT04666441|144331366|SUPERIORITY||Difference of LS Means|-0.41|STANDARD_ERROR_OF_MEAN|0.13||0.0011|TWO_SIDED|95.0|-0.66|-0.17|||ANCOVA|||Baseline Viral Load \>10\^6 copies/mL Difference vs. Placebo (log10 copies/mL)||-0.17|-0.66|0.0011
72411509|NCT04666441|144331366|SUPERIORITY||Difference of LS Means|-0.58|STANDARD_ERROR_OF_MEAN|0.15||0.0001|TWO_SIDED|95.0|-0.87|-0.29|||ANCOVA|||Baseline Viral Load \>10\^7 copies/mL Difference vs. Placebo (log10 copies/mL)||-0.29|-0.87|0.0001
72411510|NCT04666441|144331370|SUPERIORITY||Difference of LS Means|-0.49|STANDARD_ERROR_OF_MEAN|0.18||0.007||95.0|-0.85|-0.14|||Mixed Model for Repeated Measures (MMRM)|||Difference vs. Placebo, by Day 3 (log10 copies/mL)||-0.14|-0.85|0.0070
72579590|NCT01499095|144688072|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|"Stepwise closed testing approach was to assess non-inferiority and superiority sequentially:~1. Non-inferiority of HOE901-U300 vs Lantus: Upper bound of two-sided 95% confidence interval (CI) of difference between HOE901-U300 and Lantus on mITT population is \<0.4%.~2. Superiority (only if non-inferiority has been demonstrated): Upper bound of two-sided 95% CI for difference in mean change in HbA1c from baseline to endpoint between HOE901-U300 and Lantus on mITT population is \<0."|Least Squares (LS) Mean difference|-0.01|STANDARD_ERROR_OF_MEAN|0.066|||TWO_SIDED|95.0|-0.139|0.119||||||Analysis was performed using an analysis of covariance (ANCOVA) model with treatment, strata of screening HbA1c (\<8.0 and \>=8.0%), and country as fixed effects and using the HbA1c baseline value as a covariate.||0.119|-0.139|
72579591|NCT01499095|144688073|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.77||||0.038|TWO_SIDED|95.0|0.61|0.99|||Cochran-Mantel-Haenszel|||A one-sided test (at alpha=0.025) for superiority of HOE901-U300 over Lantus was to be performed in case the non-inferiority of HOE901-U300 vs Lantus for the primary endpoint was demonstrated. Analysis was performed using Cochran-Mantel-Haenszel (CMH) method with treatment as a factor and stratified on strata of screening HbA1c (\<8.0 and \>=8.0%).||0.99|0.61|0.0380
72579592|NCT01499095|144688074|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.201||0.8279|TWO_SIDED|95.0|-0.438|0.35|||ANCOVA|||Change in pre-injection SMPG was analysed using an ANCOVA model with treatment, strata of screening HbA1c (\<8.0 and \>=8.0%), and country as fixed effects and using the pre-injection SMPG baseline value as a covariate. A test for superiority of HOE901-U300 over Lantus was to be performed one-sided at level alpha = 0.025 if previous analysis for nocturnal hypoglycaemia was significant.||0.350|-0.438|0.8279
72579593|NCT01499095|144688083|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.13|STANDARD_ERROR_OF_MEAN|0.142|||TWO_SIDED|95.0|-0.152|0.415||||||Analysis was performed using Analysis of covariance (ANCOVA) model with treatment regimen and country as fixed effects and baseline (Month 6) HbA1c value as a covariate.||0.415|-0.152|
72579594|NCT01995513|144688093|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.828||||0.2176|TWO_SIDED|95.0|0.612|1.119||P-value was based on log-rank test stratified by PSA response (greater than or equal to \[\>=\] 0 percent \[%\] to less than \[\<\] 30% vs \>=30%) at Week 13 in the open-label period.|Log Rank||Hazard ratio was based on a Cox regression model (with treatment as the only covariate) stratified by PSA response (\>=0% to \<30% vs \>=30%) at Week 13 in the open-label period and is relative to Enzalutamide-placebo with \< 1 favoring Enzalutamide.|||1.119|0.612|0.2176
72579595|NCT01995513|144688094|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.874||||0.45|TWO_SIDED|95.0|0.617|1.239||P-value was based on log-rank test stratified by PSA response (\>=0% to \<30% vs \>=30%) at Week 13 in the open-label period.|Log Rank||Hazard ratio was based on a Cox regression model (with treatment as the only covariate) stratified by PSA response (\>=0% to \<30% vs \>=30%) at Week 13 in the open-label period and is relative to Enzalutamide-placebo with \< 1 favoring Enzalutamide.|||1.239|0.617|0.4500
72579596|NCT01995513|144688095|SUPERIORITY_OR_OTHER_LEGACY||Difference in Response Rate|-1.65||||0.3101|TWO_SIDED|95.0|-4.82|1.51||P-value was based on Cochran-Mantel-Haenszel mean score test stratified by PSA response (\>=0% to \<30% vs \>=30%) at Week 13 in the open-label period.|Cochran-Mantel-Haenszel||Difference in response rate was based upon standard normal approximation.|This analysis is reported for participants with \>=50% decrease from baseline in PSA response.||1.51|-4.82|0.3101
72579597|NCT01995513|144688095|SUPERIORITY_OR_OTHER_LEGACY||Difference in Response Rate|-0.04||||0.9917|TWO_SIDED|95.0|-3.9|3.82||P-value was based on Cochran-Mantel-Haenszel mean score test stratified by PSA response (\>=0% to \<30% vs \>=30%) at Week 13 in the open-label period.|Cochran-Mantel-Haenszel||Difference in response rate was based upon standard normal approximation.|This analysis is reported for participants with \>=30% decrease from baseline in PSA response.||3.82|-3.90|0.9917
72579598|NCT01995513|144688096|SUPERIORITY_OR_OTHER_LEGACY||Difference in Objective Response Rate|-5.0||||0.1653|TWO_SIDED|95.0|-11.75|1.75||P-value was based on Cochran-Mantel-Haenszel mean score test stratified by PSA response (\>=0% to \<30% vs \>=30%) at Week 13 in the open-label period.|Cochran-Mantel-Haenszel||Difference in objective response rate was based upon standard normal approximation.|This analysis is reported for participants with CR+PR.||1.75|-11.75|0.1653
72579599|NCT01995513|144688096|SUPERIORITY_OR_OTHER_LEGACY||Difference in Objective Response Rate|10.92||||0.3216|TWO_SIDED|95.0|-10.37|32.21||P-value was based on Cochran-Mantel-Haenszel mean score test stratified by PSA response (\>=0% to \<30% vs \>=30%) at Week 13 in the open-label period.|Cochran-Mantel-Haenszel||Difference in objective response rate was based upon standard normal approximation.|This analysis is reported for participants with CR+PR+SD.||32.21|-10.37|0.3216
72579600|NCT01995513|144688097|SUPERIORITY_OR_OTHER_LEGACY||Difference in Progression Rate|9.09||||0.2963|TWO_SIDED|95.0|-7.69|25.87||P-value was based on Cochran-Mantel-Haenszel mean score test stratified by PSA response (\>=0% to \<30% vs \>=30%) at Week 13 in the open-label period.|Cochran-Mantel-Haenszel||Difference in Progression Rate was based upon normal approximation.|||25.87|-7.69|0.2963
72579601|NCT01995513|144688098|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.861||||0.3818|TWO_SIDED|95.0|0.616|1.204||P-value was based on log-rank test stratified by PSA response (\>=0% to \<30% vs \>=30%) at Week 13 in the open-label period.|Log Rank||Hazard ratio was based on a Cox regression model (with treatment as the only covariate) stratified by PSA response (\>=0% to \<30% vs \>=30%) at Week 13 in the open-label period and is relative to Enzalutamide-placebo with \< 1 favoring Enzalutamide.|||1.204|0.616|0.3818
72579602|NCT01995513|144688105|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.399||||0.0739|TWO_SIDED|95.0|0.967|2.025||P-value was based on log-rank test stratified by PSA response (\>=0% to \<30% vs \>=30%) at Week 13 in the open-label period|Log Rank||Hazard ratio was based on a Cox regression model (with treatment as the only covariate) stratified by PSA response (\>=0% to \<30% vs \>=30%) at Week 13 in the open-label period and is relative to Enzalutamide-placebo with \< 1 favoring Enzalutamide.|||2.025|0.967|0.0739
72579603|NCT00247676|144688133|SUPERIORITY_OR_OTHER||clinical benefit response rate|37.8||||||95.0|22.5|55.2|||||Clinical benefit response rate: percent of patients with confirmed CR, confirmed PR, or SD for at least 12 weeks according to RECIST, relative to total treated patients.|||55.2|22.5|
72411511|NCT04666441|144331370|SUPERIORITY||Difference of LS Means|-0.69|STANDARD_ERROR_OF_MEAN|0.19||0.0002|TWO_SIDED|95.0|-1.06|-0.33|||Mixed Model for Repeated Measures (MMRM)|||Difference vs. Placebo, by Day 3 (log10 copies/mL)||-0.33|-1.06|0.0002
72411512|NCT04666441|144331370|SUPERIORITY||Difference of LS Means|-0.63|STANDARD_ERROR_OF_MEAN|0.19||0.0008||95.0|-1.0|-0.26|||Mixed Model for Repeated Measures (MMRM)|||Difference vs. Placebo, by Day 3 (log10 copies/mL)||-0.26|-1.00|0.0008
72545069|NCT04549259|144619181|OTHER|Single group change over time.|Odds Ratio (OR)|2.89||||0.38|TWO_SIDED|||||All tests performed were 2-sided. Given that the study was a pilot, we used α = .25 as a significance level cutoff and focus primarily on patterns in the data and effect sizes.|Mixed Models Analysis|||"Given that our factorial design resulted in many control participants who were assigned to alternative interventions, for this pilot we also report on changes over time in outcomes for participants randomly assigned to each intervention. These changes tested with mixed models that contained only participants assigned to each intervention. Here, time was the predictor of interest, and we again controlled for mode of survey administration."||||.38
72545070|NCT04549259|144619181|OTHER|Single group change over time.|Odds Ratio (OR)|1.25||||0.78|TWO_SIDED|||||All tests performed were 2-sided. Given that the study was a pilot, we used α = .25 as a significance level cutoff and focus primarily on patterns in the data and effect sizes.|Mixed Models Analysis|||"Given that our factorial design resulted in many control participants who were assigned to alternative interventions, for this pilot we also report on changes over time in outcomes for participants randomly assigned to each intervention. These changes tested with mixed models that contained only participants assigned to each intervention. Here, time was the predictor of interest, and we again controlled for mode of survey administration."||||.78
72545071|NCT04549259|144619181|OTHER|Single group change over time.|Odds Ratio (OR)|2.32||||0.45|TWO_SIDED|||||All tests performed were 2-sided. Given that the study was a pilot, we used α = .25 as a significance level cutoff and focus primarily on patterns in the data and effect sizes.|Mixed Models Analysis|||"Given that our factorial design resulted in many control participants who were assigned to alternative interventions, for this pilot we also report on changes over time in outcomes for participants randomly assigned to each intervention. These changes tested with mixed models that contained only participants assigned to each intervention. Here, time was the predictor of interest, and we again controlled for mode of survey administration."||||.45
72545072|NCT04549259|144619181|OTHER|Single group change over time.|Odds Ratio (OR)|0.92||||0.91|TWO_SIDED|||||All tests performed were 2-sided. Given that the study was a pilot, we used α = .25 as a significance level cutoff and focus primarily on patterns in the data and effect sizes.|Mixed Models Analysis|||"Given that our factorial design resulted in many control participants who were assigned to alternative interventions, for this pilot we also report on changes over time in outcomes for participants randomly assigned to each intervention. These changes tested with mixed models that contained only participants assigned to each intervention. Here, time was the predictor of interest, and we again controlled for mode of survey administration."||||.91
72545073|NCT04549259|144619182|SUPERIORITY||B|2.58|STANDARD_ERROR_OF_MEAN|2.8||0.36|TWO_SIDED|||||All tests performed were 2-sided. Given that the study was a pilot, we used α = .25 as a significance level cutoff and focus primarily on patterns in the data and effect sizes.|Mixed Models Analysis|||We fit a linear mixed model using the lmer function in the R package lme4. The model included a random effect for participant and utilized all available data. Predictors (fixed effects) included time (baseline vs. follow-up), random assignments, and interactions between assignments and time. We adjusted for mode of survey completion. Significant interactions indicated differential changes in outcomes over time for those randomly assigned vs. not randomly assigned to different interventions.||||.36
72579604|NCT00247676|144688138|SUPERIORITY_OR_OTHER||objective response rate|2.7||||||95.0|0.1|14.2|||||percentage of patients with confirmed CR or confirmed PR according to RECIST, relative to the total number of treated patients.|||14.2|0.1|
72579605|NCT00247676|144688142|SUPERIORITY_OR_OTHER||probability|0.324||||||95.0|0.168|0.479|||||probability derived from Kaplan-Meier estimate.|||0.479|0.168|
72579606|NCT01750190|144688172|SUPERIORITY||Least Square Mean Difference|1.85|STANDARD_ERROR_OF_MEAN|0.059|<|0.0001|TWO_SIDED|95.0|1.735|1.967|||ANCOVA|MI (Multiple Imputation) ANCOVA|Roxadustat - Placebo Treatment Difference|Treatment comparison was made using the multiple imputation strategy by combining the results of analysis of covariance (ANCOVA) model with baseline Hb and baseline estimated glomerular filtration rate (eGFR) as covariates and treatment and other randomization stratification factors, except baseline Hb (≤8 g/dL versus \>8 g/dL) and eGFR (\<30 versus ≥30 milliliters \[mL\]/minutes \[min\]/1.73 meters \[m\]\^2), as fixed effects.||1.967|1.735|<0.0001
72579607|NCT01750190|144688173|SUPERIORITY||Odds Ratio (OR)|77.56|||<|0.0001|TWO_SIDED|95.0|44.73|134.48|||Cochran-Mantel-Haenszel||Roxadustat/Placebo Odds ratio|||134.48|44.73|<0.0001
72579608|NCT01750190|144688174|SUPERIORITY||Least Square Mean Difference|1.88|STANDARD_ERROR_OF_MEAN|1.88|<|0.0001|TWO_SIDED|95.0|1.73|2.037|||Mixed Models Analysis|MMRM Analysis|Roxadustat - placebo treatment difference|Treatment comparison was made using MMRM with baseline Hb and baseline eGFR as covariates, and treatment, visit, visit-by-treatment interaction, and the randomization stratification factors, except baseline Hb (≤8 g/dL versus \>8 g/dL) and eGFR (\<30 versus ≥30 mL/min/1.73m\^2), as fixed effects.||2.037|1.730|<0.0001
72411513|NCT04666441|144331370|SUPERIORITY||Difference of LS Means|-0.48|STANDARD_ERROR_OF_MEAN|0.19||0.0125||95.0|-0.85|-0.1|||Mixed Model for Repeated Measures (MMRM)|||Difference vs. Placebo, by Day 3 (log10 copies/mL)||-0.10|-0.85|0.0125
72579609|NCT01750190|144688175|SUPERIORITY||Least Square Mean Difference|1.9|STANDARD_ERROR_OF_MEAN|0.122|<|0.0001|TWO_SIDED|95.0|1.663|2.143|||ANCOVA|MI ANCOVA|Roxadustat - placebo treatment difference|Treatment comparison was made using the multiple imputation strategy by combining the results of ANCOVA model with baseline Hb and baseline eGFR as covariates , and treatment and other randomization stratification factors, except baseline Hb (≤8 g/dL versus \>8 g/dL) and eGFR (\<30 versus ≥30 mL/min/1.73m\^2 ), as fixed effects.||2.143|1.663|<0.0001
72579610|NCT01750190|144688176|SUPERIORITY||Odds Ratio (OR)|15.47|||<|0.0001|TWO_SIDED|95.0|10.79|22.189|||Cochran-Mantel-Haenszel||Roxadustat/placebo odds ratio|||22.189|10.79|<0.0001
72411514|NCT04666441|144331370|SUPERIORITY||Difference of LS Means|-0.34|STANDARD_ERROR_OF_MEAN|0.18||0.0696||95.0|-0.7|0.03|||Mixed Model for Repeated Measures (MMRM)|||Difference vs. Placebo, by Day 3 (log10 copies/mL)||0.03|-0.70|0.0696
72545074|NCT04549259|144619182|SUPERIORITY||B|-0.42|STANDARD_ERROR_OF_MEAN|2.78||0.88|TWO_SIDED|||||All tests performed were 2-sided. Given that the study was a pilot, we used α = .25 as a significance level cutoff and focus primarily on patterns in the data and effect sizes.|Mixed Models Analysis|||We fit a linear mixed model using the lmer function in the R package lme4. The model included a random effect for participant and utilized all available data. Predictors (fixed effects) included time (baseline vs. follow-up), random assignments, and interactions between assignments and time. We adjusted for mode of survey completion. Significant interactions indicated differential changes in outcomes over time for those randomly assigned vs. not randomly assigned to different interventions.||||.88
72545075|NCT04549259|144619182|SUPERIORITY||B|0.38|STANDARD_ERROR_OF_MEAN|2.8||0.89|TWO_SIDED|||||All tests performed were 2-sided. Given that the study was a pilot, we used α = .25 as a significance level cutoff and focus primarily on patterns in the data and effect sizes.|Mixed Models Analysis|||We fit a linear mixed model using the lmer function in the R package lme4. The model included a random effect for participant and utilized all available data. Predictors (fixed effects) included time (baseline vs. follow-up), random assignments, and interactions between assignments and time. We adjusted for mode of survey completion. Significant interactions indicated differential changes in outcomes over time for those randomly assigned vs. not randomly assigned to different interventions.||||.89
72545076|NCT04549259|144619182|SUPERIORITY||B|-0.99|STANDARD_ERROR_OF_MEAN|2.78||0.73|TWO_SIDED|||||All tests performed were 2-sided. Given that the study was a pilot, we used α = .25 as a significance level cutoff and focus primarily on patterns in the data and effect sizes.|Mixed Models Analysis|||We fit a linear mixed model using the lmer function in the R package lme4. The model included a random effect for participant and utilized all available data. Predictors (fixed effects) included time (baseline vs. follow-up), random assignments, and interactions between assignments and time. We adjusted for mode of survey completion. Significant interactions indicated differential changes in outcomes over time for those randomly assigned vs. not randomly assigned to different interventions.||||.73
72545077|NCT04549259|144619182|OTHER|Single group change over time.|B|4.88|STANDARD_ERROR_OF_MEAN|1.83||0.01|TWO_SIDED|||||All tests performed were 2-sided. Given that the study was a pilot, we used α = .25 as a significance level cutoff and focus primarily on patterns in the data and effect sizes.|Mixed Models Analysis|||"Given that our factorial design resulted in many control participants who were assigned to alternative interventions, for this pilot we also report on changes over time in outcomes for participants randomly assigned to each intervention. These changes tested with mixed models that contained only participants assigned to each intervention. Here, time was the predictor of interest, and we again controlled for mode of survey administration."||||.01
72545078|NCT04549259|144619182|OTHER|Single group change over time.|B|3.28|STANDARD_ERROR_OF_MEAN|2.03||0.12|TWO_SIDED|||||All tests performed were 2-sided. Given that the study was a pilot, we used α = .25 as a significance level cutoff and focus primarily on patterns in the data and effect sizes.|Mixed Models Analysis|||"Given that our factorial design resulted in many control participants who were assigned to alternative interventions, for this pilot we also report on changes over time in outcomes for participants randomly assigned to each intervention. These changes tested with mixed models that contained only participants assigned to each intervention. Here, time was the predictor of interest, and we again controlled for mode of survey administration."||||.12
72545079|NCT04549259|144619182|OTHER|Single group change over time.|B|3.82|STANDARD_ERROR_OF_MEAN|2.06||0.08|TWO_SIDED|||||All tests performed were 2-sided. Given that the study was a pilot, we used α = .25 as a significance level cutoff and focus primarily on patterns in the data and effect sizes.|Mixed Models Analysis|||"Given that our factorial design resulted in many control participants who were assigned to alternative interventions, for this pilot we also report on changes over time in outcomes for participants randomly assigned to each intervention. These changes tested with mixed models that contained only participants assigned to each intervention. Here, time was the predictor of interest, and we again controlled for mode of survey administration."||||.08
72579611|NCT01750190|144688177|SUPERIORITY||Least Square Mean Difference|-17.26|STANDARD_ERROR_OF_MEAN|1.73|<|0.0001|TWO_SIDED|95.0|-20.65|-13.87|||Mixed Models Analysis|MMRM Analysis|Roxadustat- placebo treatment difference|Treatment comparison was made using MMRM with baseline LDL cholesterol as a covariate, and treatment, visit, visit-by-treatment interaction, and the randomization stratification factors as fixed effects.||-13.87|-20.65|<0.0001
72579612|NCT01750190|144688178|SUPERIORITY||Least Square Mean Difference|0.21|STANDARD_ERROR_OF_MEAN|0.528||0.6924|TWO_SIDED|95.0|-0.827|1.245|||ANCOVA|MI ANCOVA|Roxadustat - placebo treatment difference|||1.245|-0.827|0.6924
72579613|NCT01750190|144688179|SUPERIORITY||Hazard Ratio (HR)|0.26|||<|0.0001|TWO_SIDED|95.0|0.165|0.406||From a Cox Proportional hazards model adjusting for baseline Hb, baseline eGFR and other randomization stratification factors, except baseline Hb (≤8 g/dL versus \>8 g/dL) and eGFR (\<30 versus ≥30 mL/min/1.73 m\^2).|Cox Proportional hazards model|||||0.406|0.165|<0.0001
72411515|NCT04666441|144331370|SUPERIORITY||Difference of LS Means|-0.43|STANDARD_ERROR_OF_MEAN|0.18||0.0187|TWO_SIDED|95.0|-0.79|-0.07|||Mixed Model for Repeated Measures (MMRM)|||Difference vs. Placebo, by Day 3 (log10 copies/mL)||-0.07|-0.79|0.0187
72411516|NCT04666441|144331370|SUPERIORITY||Difference of LS Means|-0.96|STANDARD_ERROR_OF_MEAN|0.22|<|0.0001||95.0|-1.39|-0.52|||Mixed Model for Repeated Measures (MMRM)|||Difference vs. Placebo, by Day 5 (log10 copies/mL)||-0.52|-1.39|<0.0001
72411517|NCT04666441|144331370|SUPERIORITY||Difference of LS Means|-1.09|STANDARD_ERROR_OF_MEAN|0.23|<|0.0001||95.0|-1.53|-0.64|||Mixed Model for Repeated Measures (MMRM)|||Difference vs. Placebo, by Day 5 (log10 copies/mL)||-0.64|-1.53|<0.0001
72411518|NCT04666441|144331370|SUPERIORITY||Difference of LS Means|-1.03|STANDARD_ERROR_OF_MEAN|0.23|<|0.0001||95.0|-1.48|-0.59|||Mixed Model for Repeated Measures (MMRM)|||Difference vs. Placebo, by Day 5 (log10 copies/mL)||-0.59|-1.48|<0.0001
72411519|NCT04666441|144331370|SUPERIORITY||Difference of LS Means|-1.05|STANDARD_ERROR_OF_MEAN|0.23|<|0.0001||95.0|-1.5|-0.6|||Mixed Model for Repeated Measures (MMRM)|||Difference vs. Placebo, by Day 5 (log10 copies/mL)||-0.60|-1.50|<0.0001
72411520|NCT04666441|144331370|SUPERIORITY||Difference of LS Means|-0.9|STANDARD_ERROR_OF_MEAN|0.22|<|0.0001|TWO_SIDED|95.0|-1.34|-0.46|||Mixed Model for Repeated Measures (MMRM)|||Difference vs. Placebo, by Day 5 (log10 copies/mL)||-0.46|-1.34|<0.0001
72545080|NCT04549259|144619182|OTHER|Single group change over time.|B|3.19|STANDARD_ERROR_OF_MEAN|1.99||0.12|TWO_SIDED|||||All tests performed were 2-sided. Given that the study was a pilot, we used α = .25 as a significance level cutoff and focus primarily on patterns in the data and effect sizes.|Mixed Models Analysis|||"Given that our factorial design resulted in many control participants who were assigned to alternative interventions, for this pilot we also report on changes over time in outcomes for participants randomly assigned to each intervention. These changes tested with mixed models that contained only participants assigned to each intervention. Here, time was the predictor of interest, and we again controlled for mode of survey administration."||||.12
72411521|NCT04666441|144331370|SUPERIORITY||Difference of LS Means|-0.92|STANDARD_ERROR_OF_MEAN|0.22|<|0.0001||95.0|-1.35|-0.48|||Mixed Model for Repeated Measures (MMRM)|||Difference vs. Placebo, by Day 5 (log10 copies/mL)||-0.48|-1.35|<0.0001
72411522|NCT04666441|144331370|SUPERIORITY||Difference of LS Means|-0.79|STANDARD_ERROR_OF_MEAN|0.22||0.0004||95.0|-1.23|-0.35|||Mixed Model for Repeated Measures (MMRM)|||Difference vs. Placebo, by Day 7 (log10 copies/mL)||-0.35|-1.23|0.0004
72411523|NCT04666441|144331370|SUPERIORITY||Difference of LS Means|-0.63|STANDARD_ERROR_OF_MEAN|0.23||0.0058||95.0|-1.08|-0.18|||Mixed Model for Repeated Measures (MMRM)|||Difference vs. Placebo, by Day 7 (log10 copies/mL)||-0.18|-1.08|0.0058
72411524|NCT04666441|144331370|SUPERIORITY||Difference of LS Means|-0.66|STANDARD_ERROR_OF_MEAN|0.23||0.0046||95.0|-1.11|-0.2|||Mixed Model for Repeated Measures (MMRM)|||Difference vs. Placebo, by Day 7 (log10 copies/mL)||-0.20|-1.11|0.0046
72545081|NCT04549259|144619183|SUPERIORITY||Odds Ratio (OR)|22.3||||0.049|TWO_SIDED|||||All tests performed were 2-sided. Given that the study was a pilot, we used α = .25 as a significance level cutoff and focus primarily on patterns in the data and effect sizes.|Mixed Models Analysis|||We fit a generalized linear mixed model using the glmer function and a logit link in the R package lme4. The model included a random effect for participant. Predictors (fixed effects) included time (baseline vs. follow-up), random assignments, and interactions between assignments and time. We adjusted for mode of survey completion. Significant interactions indicated differential changes in outcomes over time for those randomly assigned vs. not randomly assigned to different interventions.||||.049
72545082|NCT04549259|144619183|SUPERIORITY||Odds Ratio (OR)|1.86||||0.66|TWO_SIDED|||||All tests performed were 2-sided. Given that the study was a pilot, we used α = .25 as a significance level cutoff and focus primarily on patterns in the data and effect sizes.|Mixed Models Analysis|||We fit a generalized linear mixed model using the glmer function and a logit link in the R package lme4. The model included a random effect for participant. Predictors (fixed effects) included time (baseline vs. follow-up), random assignments, and interactions between assignments and time. We adjusted for mode of survey completion. Significant interactions indicated differential changes in outcomes over time for those randomly assigned vs. not randomly assigned to different interventions.||||.66
72545083|NCT04549259|144619183|SUPERIORITY||Odds Ratio (OR)|0.68||||0.78|TWO_SIDED|||||All tests performed were 2-sided. Given that the study was a pilot, we used α = .25 as a significance level cutoff and focus primarily on patterns in the data and effect sizes.|Mixed Models Analysis|||We fit a generalized linear mixed model using the glmer function and a logit link in the R package lme4. The model included a random effect for participant. Predictors (fixed effects) included time (baseline vs. follow-up), random assignments, and interactions between assignments and time. We adjusted for mode of survey completion. Significant interactions indicated differential changes in outcomes over time for those randomly assigned vs. not randomly assigned to different interventions.||||.78
72545084|NCT04549259|144619183|SUPERIORITY||Odds Ratio (OR)|0.43||||0.54|TWO_SIDED|||||All tests performed were 2-sided. Given that the study was a pilot, we used α = .25 as a significance level cutoff and focus primarily on patterns in the data and effect sizes.|Mixed Models Analysis|||We fit a generalized linear mixed model using the glmer function and a logit link in the R package lme4. The model included a random effect for participant. Predictors (fixed effects) included time (baseline vs. follow-up), random assignments, and interactions between assignments and time. We adjusted for mode of survey completion. Significant interactions indicated differential changes in outcomes over time for those randomly assigned vs. not randomly assigned to different interventions.||||.54
72545085|NCT04549259|144619183|OTHER|Single group change over time.|Odds Ratio (OR)|6.26||||0.09|TWO_SIDED|||||All tests performed were 2-sided. Given that the study was a pilot, we used α = .25 as a significance level cutoff and focus primarily on patterns in the data and effect sizes.|Mixed Models Analysis|||"Given that our factorial design resulted in many control participants who were assigned to alternative interventions, for this pilot we also report on changes over time in outcomes for participants randomly assigned to each intervention. These changes tested with mixed models that contained only participants assigned to each intervention. Here, time was the predictor of interest, and we again controlled for mode of survey administration."||||.09
72545086|NCT04549259|144619183|OTHER|Single group change over time.|Odds Ratio (OR)|2.05||||0.4|TWO_SIDED|||||All tests performed were 2-sided. Given that the study was a pilot, we used α = .25 as a significance level cutoff and focus primarily on patterns in the data and effect sizes.|Mixed Models Analysis|||"Given that our factorial design resulted in many control participants who were assigned to alternative interventions, for this pilot we also report on changes over time in outcomes for participants randomly assigned to each intervention. These changes tested with mixed models that contained only participants assigned to each intervention. Here, time was the predictor of interest, and we again controlled for mode of survey administration."||||.40
72411525|NCT04666441|144331370|SUPERIORITY||Difference of LS Means|-0.73|STANDARD_ERROR_OF_MEAN|0.23||0.0019||95.0|-1.18|-0.27|||Mixed Model for Repeated Measures (MMRM)|||Difference vs. Placebo, by Day 7 (log10 copies/mL)||-0.27|-1.18|0.0019
72579614|NCT01750190|144688180|SUPERIORITY||Hazard Ratio (HR)|0.17|||<|0.0001|TWO_SIDED|95.0|0.108|0.267||From a Cox Proportional hazards model adjusting for baseline Hb, baseline eGFR and the randomization stratification factors, except baseline Hb (\<=8 g/dL versus \>8 g/dL) and eGFR (\<30 versus \>=30 mL/min/1.73m\^2).|Cox Proportional hazards model|||First 24 Weeks of Treatment||0.267|0.108|<0.0001
72579615|NCT01750190|144688180|SUPERIORITY||Hazard Ratio (HR)|0.19|||<|0.0001|TWO_SIDED|95.0|0.138|0.276||From a Cox Proportional hazards model adjusting for baseline Hb, baseline eGFR and other randomization stratification factors, except baseline Hb (≤8 g/dL versus \>8 g/dL) and eGFR (\<30 versus ≥30 mL/min/1.73 m\^2).|Cox Proportional hazards model|||First 52 Weeks of Treatment||0.276|0.138|<0.0001
72411526|NCT04666441|144331370|SUPERIORITY||Difference of LS Means|-0.89|STANDARD_ERROR_OF_MEAN|0.23|<|0.0001||95.0|-1.33|-0.44|||Mixed Model for Repeated Measures (MMRM)|||Difference vs. Placebo, by Day 7 (log10 copies/mL)||-0.44|-1.33|<0.0001
72411527|NCT04666441|144331370|SUPERIORITY||Difference of LS Means|-0.6|STANDARD_ERROR_OF_MEAN|0.22||0.0079||95.0|-1.04|-0.16|||Mixed Model for Repeated Measures (MMRM)|||Difference vs. Placebo, by Day 7 (log10 copies/mL)||-0.16|-1.04|0.0079
72579616|NCT04194645|144688311|OTHER|The statistical model used for the analysis of the endpoint was an Analysis of Variance (ANOVA ) model on the logarithmic scale. This model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|Ratio of geometric mean (T2/R)|97.71|||||TWO_SIDED|90.0|91.45|104.4|||ANOVA||Intra- individual coefficient of variation (gCV %) = 8.9|No formal hypothesis was tested.||104.40|91.45|
72579617|NCT04194645|144688311|OTHER|The statistical model used for the analysis of the endpoint was an Analysis of Variance (ANOVA ) model on the logarithmic scale. This model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|Ratio of geometric mean (T1/T2)|112.88|||||TWO_SIDED|90.0|98.82|128.94|||ANOVA||Intra- individual coefficient of variation (gCV %) = 16.8|No formal hypothesis was tested.||128.94|98.82|
72579618|NCT04194645|144688312|OTHER|The statistical model used for the analysis of the endpoint was an Analysis of Variance (ANOVA ) model on the logarithmic scale. This model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|Ratio of geometric mean (T2/R)|48.02|||||TWO_SIDED|90.0|41.86|55.09|||ANOVA||Intra- individual coefficient of variation (gCV %) = 18.5|No formal hypothesis was tested.||55.09|41.86|
72579619|NCT04194645|144688312|OTHER|The statistical model used for the analysis of the endpoint was an Analysis of Variance (ANOVA ) model on the logarithmic scale. This model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|Ratio of geometric mean (T1/T2)|122.8|||||TWO_SIDED|90.0|105.04|143.56|||ANOVA||Intra- individual coefficient of variation (gCV %) = 19.8|No formal hypothesis was tested.||143.56|105.04|
72579620|NCT04194645|144688315|OTHER|The statistical model used for the analysis of the endpoint was an Analysis of Variance (ANOVA ) model on the logarithmic scale. This model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|Ratio of geometric mean (T2/R)|98.32|||||TWO_SIDED|90.0|91.98|105.09|||ANOVA||Intra- individual coefficient of variation (gCV %) = 8.9|No formal hypothesis was tested.||105.09|91.98|
72545087|NCT04549259|144619183|OTHER|Single group change over time.|Odds Ratio (OR)|1.42||||0.66|TWO_SIDED|||||All tests performed were 2-sided. Given that the study was a pilot, we used α = .25 as a significance level cutoff and focus primarily on patterns in the data and effect sizes.|Mixed Models Analysis|||"Given that our factorial design resulted in many control participants who were assigned to alternative interventions, for this pilot we also report on changes over time in outcomes for participants randomly assigned to each intervention. These changes tested with mixed models that contained only participants assigned to each intervention. Here, time was the predictor of interest, and we again controlled for mode of survey administration."||||.66
72545088|NCT04549259|144619183|OTHER|Single group change over time.|Odds Ratio (OR)|1.14||||0.87|TWO_SIDED|||||All tests performed were 2-sided. Given that the study was a pilot, we used α = .25 as a significance level cutoff and focus primarily on patterns in the data and effect sizes.|Mixed Models Analysis|||"Given that our factorial design resulted in many control participants who were assigned to alternative interventions, for this pilot we also report on changes over time in outcomes for participants randomly assigned to each intervention. These changes tested with mixed models that contained only participants assigned to each intervention. Here, time was the predictor of interest, and we again controlled for mode of survey administration."||||.87
72545089|NCT04549259|144619184|SUPERIORITY||B|-1.74|STANDARD_ERROR_OF_MEAN|1.47||0.24|TWO_SIDED|||||All tests performed were 2-sided. Given that the study was a pilot, we used α = .25 as a significance level cutoff and focus primarily on patterns in the data and effect sizes.|Mixed Models Analysis|||We fit a linear mixed model using the lmer function in the R package lme4. The model included a random effect for participant and utilized all available data. Predictors (fixed effects) included time (baseline vs. follow-up), random assignments, and interactions between assignments and time. We adjusted for mode of survey completion. Significant interactions indicated differential changes in outcomes over time for those randomly assigned vs. not randomly assigned to different interventions.||||.24
72545090|NCT04549259|144619184|SUPERIORITY||B|-2.05|STANDARD_ERROR_OF_MEAN|1.46||0.17|TWO_SIDED|||||All tests performed were 2-sided. Given that the study was a pilot, we used α = .25 as a significance level cutoff and focus primarily on patterns in the data and effect sizes.|Mixed Models Analysis|||We fit a linear mixed model using the lmer function in the R package lme4. The model included a random effect for participant and utilized all available data. Predictors (fixed effects) included time (baseline vs. follow-up), random assignments, and interactions between assignments and time. We adjusted for mode of survey completion. Significant interactions indicated differential changes in outcomes over time for those randomly assigned vs. not randomly assigned to different interventions.||||.17
72545091|NCT04549259|144619184|SUPERIORITY||B|0.64|STANDARD_ERROR_OF_MEAN|1.47||0.66|TWO_SIDED|||||All tests performed were 2-sided. Given that the study was a pilot, we used α = .25 as a significance level cutoff and focus primarily on patterns in the data and effect sizes.|Mixed Models Analysis|||We fit a linear mixed model using the lmer function in the R package lme4. The model included a random effect for participant and utilized all available data. Predictors (fixed effects) included time (baseline vs. follow-up), random assignments, and interactions between assignments and time. We adjusted for mode of survey completion. Significant interactions indicated differential changes in outcomes over time for those randomly assigned vs. not randomly assigned to different interventions.||||.66
72545092|NCT04549259|144619184|SUPERIORITY||B|-0.21|STANDARD_ERROR_OF_MEAN|1.46||0.89|TWO_SIDED|||||All tests performed were 2-sided. Given that the study was a pilot, we used α = .25 as a significance level cutoff and focus primarily on patterns in the data and effect sizes.|Mixed Models Analysis|||We fit a linear mixed model using the lmer function in the R package lme4. The model included a random effect for participant and utilized all available data. Predictors (fixed effects) included time (baseline vs. follow-up), random assignments, and interactions between assignments and time. We adjusted for mode of survey completion. Significant interactions indicated differential changes in outcomes over time for those randomly assigned vs. not randomly assigned to different interventions.||||.89
72545093|NCT04549259|144619184|OTHER|Single group change over time.|B|-1.6|STANDARD_ERROR_OF_MEAN|0.75||0.045|TWO_SIDED|||||All tests performed were 2-sided. Given that the study was a pilot, we used α = .25 as a significance level cutoff and focus primarily on patterns in the data and effect sizes.|Mixed Models Analysis|||"Given that our factorial design resulted in many control participants who were assigned to alternative interventions, for this pilot we also report on changes over time in outcomes for participants randomly assigned to each intervention. These changes tested with mixed models that contained only participants assigned to each intervention. Here, time was the predictor of interest, and we again controlled for mode of survey administration."||||.045
72545094|NCT04549259|144619184|OTHER|Single group change over time.|B|-1.81|STANDARD_ERROR_OF_MEAN|0.95||0.07|TWO_SIDED|||||All tests performed were 2-sided. Given that the study was a pilot, we used α = .25 as a significance level cutoff and focus primarily on patterns in the data and effect sizes.|Mixed Models Analysis|||"Given that our factorial design resulted in many control participants who were assigned to alternative interventions, for this pilot we also report on changes over time in outcomes for participants randomly assigned to each intervention. These changes tested with mixed models that contained only participants assigned to each intervention. Here, time was the predictor of interest, and we again controlled for mode of survey administration."||||.07
72545095|NCT04549259|144619184|OTHER|Single group change over time.|B|-0.51|STANDARD_ERROR_OF_MEAN|0.88||0.57|TWO_SIDED|||||All tests performed were 2-sided. Given that the study was a pilot, we used α = .25 as a significance level cutoff and focus primarily on patterns in the data and effect sizes.|Mixed Models Analysis|||"Given that our factorial design resulted in many control participants who were assigned to alternative interventions, for this pilot we also report on changes over time in outcomes for participants randomly assigned to each intervention. These changes tested with mixed models that contained only participants assigned to each intervention. Here, time was the predictor of interest, and we again controlled for mode of survey administration."||||.57
72545096|NCT04549259|144619184|OTHER|Single group change over time.|B|-0.92|STANDARD_ERROR_OF_MEAN|1.12||0.42|TWO_SIDED|||||All tests performed were 2-sided. Given that the study was a pilot, we used α = .25 as a significance level cutoff and focus primarily on patterns in the data and effect sizes.|Mixed Models Analysis|||"Given that our factorial design resulted in many control participants who were assigned to alternative interventions, for this pilot we also report on changes over time in outcomes for participants randomly assigned to each intervention. These changes tested with mixed models that contained only participants assigned to each intervention. Here, time was the predictor of interest, and we again controlled for mode of survey administration."||||.42
72545097|NCT01492582|144619194|NON_INFERIORITY|Non-inferiority required that the lower bound of the one-sided 99.688% confidence interval (CI) of the geometric mean titer (GMT) ratio was \>0.5.|lower bound one-sided CI of GMT ratio|1.74|||||ONE_SIDED||||||||GMT ratio = GMT (cancer survivor) / GMT (historical healthy population)|"Historical Healthy Population Reference:~QUADRIVALENT~Male and female, all age groups:~Merck Pub 9883616 (Gardasil Package Insert, April 2011, pp 24-26)"||||
72545098|NCT01492582|144619194|NON_INFERIORITY|Non-inferiority required that the lower bound of the one-sided 99.688% confidence interval (CI) of the geometric mean titer (GMT) ratio was \>0.5.|lower bound one-sided CI of GMT ratio|1.76|||||TWO_SIDED|||||||||"Historical Healthy Population Reference:~QUADRIVALENT~Male and female, all age groups:~Merck Pub 9883616 (Gardasil Package Insert, April 2011, pp 24-26)"|GMT ratio = GMT (cancer survivor) / GMT (historical healthy population)|||
72545099|NCT01492582|144619194|NON_INFERIORITY|Non-inferiority required that the lower bound of the one-sided 99.688% confidence interval (CI) of the geometric mean titer (GMT) ratio was \>0.5.|lower bound one-sided CI of GMT ratio|2.15|||||TWO_SIDED|||||||||"Historical Healthy Population Reference:~QUADRIVALENT~Male and female, all age groups:~Merck Pub 9883616 (Gardasil Package Insert, April 2011, pp 24-26)"|GMT ratio = GMT (cancer survivor) / GMT (historical healthy population)|||
72545100|NCT01492582|144619194|NON_INFERIORITY|Non-inferiority required that the lower bound of the one-sided 99.688% confidence interval (CI) of the geometric mean titer (GMT) ratio was \>0.5.|lower bound one-sided CI of GMT ratio|1.0|||||TWO_SIDED|||||||||"Historical Healthy Population Reference:~QUADRIVALENT~Male and female, all age groups:~Merck Pub 9883616 (Gardasil Package Insert, April 2011, pp 24-26)"|GMT ratio = GMT (cancer survivor) / GMT (historical healthy population)|||
72545101|NCT01492582|144619194|NON_INFERIORITY|Non-inferiority required that the lower bound of the one-sided 99.688% confidence interval (CI) of the geometric mean titer (GMT) ratio was \>0.5.|lower bound one-sided CI of GMT ratio|1.52|||||TWO_SIDED|||||||||"Historical Healthy Population Reference:~QUADRIVALENT~Male and female, all age groups:~Merck Pub 9883616 (Gardasil Package Insert, April 2011, pp 24-26)"|GMT ratio = GMT (cancer survivor) / GMT (historical healthy population)|||
72545102|NCT01492582|144619194|NON_INFERIORITY|Non-inferiority required that the lower bound of the one-sided 99.688% confidence interval (CI) of the geometric mean titer (GMT) ratio was \>0.5.|lower bound one-sided CI of GMT ratio|1.48|||||TWO_SIDED|||||||||"Historical Healthy Population Reference:~QUADRIVALENT~Male and female, all age groups:~Merck Pub 9883616 (Gardasil Package Insert, April 2011, pp 24-26)"|GMT ratio = GMT (cancer survivor) / GMT (historical healthy population)|||
72545103|NCT01492582|144619194|NON_INFERIORITY|Non-inferiority required that the lower bound of the one-sided 99.688% confidence interval (CI) of the geometric mean titer (GMT) ratio was \>0.5.|lower bound one-sided CI of GMT ratio|2.48|||||TWO_SIDED|||||||||"Historical Healthy Population Reference:~QUADRIVALENT~Male and female, all age groups:~Merck Pub 9883616 (Gardasil Package Insert, April 2011, pp 24-26)"|GMT ratio = GMT (cancer survivor) / GMT (historical healthy population)|||
72545104|NCT01492582|144619194|NON_INFERIORITY|Non-inferiority required that the lower bound of the one-sided 99.688% confidence interval (CI) of the geometric mean titer (GMT) ratio was \>0.5.|lower bound one-sided CI of GMT ratio|1.0|||||TWO_SIDED|||||||||"Historical Healthy Population Reference:~QUADRIVALENT~Male and female, all age groups:~Merck Pub 9883616 (Gardasil Package Insert, April 2011, pp 24-26)"|GMT ratio = GMT (cancer survivor) / GMT (historical healthy population)|||
72545105|NCT01492582|144619194|NON_INFERIORITY|Non-inferiority required that the lower bound of the one-sided 99.688% confidence interval (CI) of the geometric mean titer (GMT) ratio was \>0.5.|lower bound one-sided CI GMT ratio|1.23|||||TWO_SIDED|||||||||"Historical Healthy Population Reference:~NONAVALENT~Girls 9-15, Boys 9-15, Women 16-26:~Petersen LK, Restrepo J, Moreira ED, Jr., et al. Impact of baseline covariates on the immunogenicity of the 9-valent HPV vaccine - A combined analysis of five phase III clinical trials. Papillomavirus Res. 2017;3:105-115;"|GMT ratio = GMT (cancer survivor) / GMT (historical healthy population)|||
72545106|NCT01492582|144619194|NON_INFERIORITY|Non-inferiority required that the lower bound of the one-sided 99.688% confidence interval (CI) of the geometric mean titer (GMT) ratio was \>0.5.|lower bound one-sided CI of GMT ratio|1.12|||||TWO_SIDED|||||||||"Historical Healthy Population Reference:~NONAVALENT~Girls 9-15, Boys 9-15, Women 16-26:~Petersen LK, Restrepo J, Moreira ED, Jr., et al. Impact of baseline covariates on the immunogenicity of the 9-valent HPV vaccine - A combined analysis of five phase III clinical trials. Papillomavirus Res. 2017;3:105-115;"|GMT ratio = GMT (cancer survivor) / GMT (historical healthy population)|||
72545107|NCT01492582|144619194|NON_INFERIORITY|Non-inferiority required that the lower bound of the one-sided 99.688% confidence interval (CI) of the geometric mean titer (GMT) ratio was \>0.5.|lower bound one-sided CI of GMT ratio|1.46|||||TWO_SIDED|||||||||"Historical Healthy Population Reference:~NONAVALENT~Men 16-26:~Castellsague X, Giuliano AR, Goldstone S, et al. Immunogenicity and safety of the 9-valent HPV vaccine in men. Vaccine. 2015;33(48):6892-6901. (HM data)."|GMT ratio = GMT (cancer survivor) / GMT (historical healthy population)|||
72545108|NCT01492582|144619194|NON_INFERIORITY|Non-inferiority required that the lower bound of the one-sided 99.688% confidence interval (CI) of the geometric mean titer (GMT) ratio was \>0.5.|lower bound one-sided CI of GMT ratio|1.61|||||TWO_SIDED|||||||||"Historical Healthy Population Reference:~NONAVALENT~Girls 9-15, Boys 9-15, Women 16-26:~Petersen LK, Restrepo J, Moreira ED, Jr., et al. Impact of baseline covariates on the immunogenicity of the 9-valent HPV vaccine - A combined analysis of five phase III clinical trials. Papillomavirus Res. 2017;3:105-115;"|GMT ratio = GMT (cancer survivor) / GMT (historical healthy population)|||
72545109|NCT01492582|144619194|NON_INFERIORITY|Non-inferiority required that the lower bound of the one-sided 99.688% confidence interval (CI) of the geometric mean titer (GMT) ratio was \>0.5.|lower bound one-sided CI of GMT ratio|1.39|||||TWO_SIDED|||||||||"Historical Healthy Population Reference:~NONAVALENT~Girls 9-15, Boys 9-15, Women 16-26:~Petersen LK, Restrepo J, Moreira ED, Jr., et al. Impact of baseline covariates on the immunogenicity of the 9-valent HPV vaccine - A combined analysis of five phase III clinical trials. Papillomavirus Res. 2017;3:105-115;"|GMT ratio = GMT (cancer survivor) / GMT (historical healthy population)|||
72545110|NCT01492582|144619194|NON_INFERIORITY|Non-inferiority required that the lower bound of the one-sided 99.688% confidence interval (CI) of the geometric mean titer (GMT) ratio was \>0.5.|lower bound one-sided CI of GMT ratio|1.1|||||TWO_SIDED|||||||||"Historical Healthy Population Reference:~NONAVALENT~Girls 9-15, Boys 9-15, Women 16-26:~Petersen LK, Restrepo J, Moreira ED, Jr., et al. Impact of baseline covariates on the immunogenicity of the 9-valent HPV vaccine - A combined analysis of five phase III clinical trials. Papillomavirus Res. 2017;3:105-115;"|GMT ratio = GMT (cancer survivor) / GMT (historical healthy population)|||
72545111|NCT01492582|144619194|NON_INFERIORITY|Non-inferiority required that the lower bound of the one-sided 99.688% confidence interval (CI) of the geometric mean titer (GMT) ratio was \>0.5.|lower bound one-sided CI of GMT ratio|1.65|||||TWO_SIDED|||||||||"Historical Healthy Population Reference:~NONAVALENT~Men 16-26:~Castellsague X, Giuliano AR, Goldstone S, et al. Immunogenicity and safety of the 9-valent HPV vaccine in men. Vaccine. 2015;33(48):6892-6901. (HM data)."|GMT ratio = GMT (cancer survivor) / GMT (historical healthy population)|||
72545112|NCT01492582|144619194|NON_INFERIORITY|Non-inferiority required that the lower bound of the one-sided 99.688% confidence interval (CI) of the geometric mean titer (GMT) ratio was \>0.5.|lower bound one-sided CI of GMT ratio|-0.44|||||TWO_SIDED|||||||||"Historical Healthy Population Reference:~NONAVALENT~Girls 9-15, Boys 9-15, Women 16-26:~Petersen LK, Restrepo J, Moreira ED, Jr., et al. Impact of baseline covariates on the immunogenicity of the 9-valent HPV vaccine - A combined analysis of five phase III clinical trials. Papillomavirus Res. 2017;3:105-115;"|GMT ratio = GMT (cancer survivor) / GMT (historical healthy population)|||
72579621|NCT04194645|144688315|OTHER|The statistical model used for the analysis of the endpoint was an Analysis of Variance (ANOVA ) model on the logarithmic scale. This model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|Ratio of geometric mean (T1/T2)|112.94|||||TWO_SIDED|90.0|98.75|129.18|||ANOVA||Intra- individual coefficient of variation (gCV %) = 16.9|No formal hypothesis was tested.||129.18|98.75|
72579622|NCT03076775|144688316|SUPERIORITY|||||||0.97|||||||Wilcoxon (Mann-Whitney)|||||||0.97
72579623|NCT03076775|144688317|SUPERIORITY|||||||0.24|||||||Wilcoxon (Mann-Whitney)|||||||0.24
72579624|NCT03076775|144688318|SUPERIORITY|||||||0.15|||||||Wilcoxon (Mann-Whitney)|||||||0.15
72579625|NCT03076775|144688319|SUPERIORITY|||||||0.55|||||||Wilcoxon (Mann-Whitney)|||||||0.55
72579626|NCT03076775|144688320|SUPERIORITY|||||||0.83|||||||Chi-squared|||||||0.83
72545113|NCT01492582|144619195|SUPERIORITY||||||<|0.001|||||||Chi-squared, Corrected|||Injection site - Pain, any; Injection site - Swelling, any; Injection site - Erythema, any; Systemic - Nausea Historical Healthy Population: Reported from Gardasil Package Insert 04/2015, Tables 1, 2, 5, and 6||||<0.001
72545114|NCT01492582|144619195|SUPERIORITY|||||||0.03|||||||Chi-squared, Corrected|||Systemic - Fever Historical Healthy Population: Reported from Gardasil Package Insert 04/2015, Tables 1, 2, 5, and 6||||0.03
72579627|NCT03076775|144688321|SUPERIORITY|||||||0.79|||||||Chi-squared|||||||0.79
72579628|NCT03076775|144688322|SUPERIORITY|||||||0.97|||||||t-test, 2 sided|||||||0.97
72579629|NCT03076775|144688323|SUPERIORITY|||||||0.44|||||||Wilcoxon (Mann-Whitney)|||||||0.44
72579630|NCT03076775|144688324|SUPERIORITY|||||||0.16|||||||Chi-squared|||||||0.16
72579631|NCT03076775|144688325|SUPERIORITY|||||||0.59|||||||Wilcoxon (Mann-Whitney)|||||||0.59
72545115|NCT01492582|144619195|SUPERIORITY|||||||0.48|||||||Chi-squared, Corrected|||Systemic - Dizziness Historical Healthy Population: Reported from Gardasil Package Insert 04/2015, Tables 1, 2, 5, and 6||||0.48
72579632|NCT01783886|144688331|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.1|||<|0.0001|TWO_SIDED|97.5|10.9|17.2|||ANCOVA||Least Square (LS) mean difference from ANCOVA. The estimate is calculated as EYLEA minus Laser.|||17.2|10.9|<0.0001
72579633|NCT01783886|144688331|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.6|||<|0.0001|TWO_SIDED|97.5|10.2|16.9|||ANCOVA||LS mean difference from ANCOVA. The estimate is calculated as EYLEA minus Laser.|||16.9|10.2|<0.0001
72579634|NCT01783886|144688332|SUPERIORITY_OR_OTHER||CMH adjusted difference|47.4|||<|0.0001|TWO_SIDED|97.5|35.0|59.9|||Cochran-Mantel-Haenszel||Cochran-Mantel-Haenszel (CMH). The estimate is calculated as EYLEA minus Laser.|||59.9|35.0|<0.0001
72579635|NCT01783886|144688332|SUPERIORITY_OR_OTHER||CMH adjusted difference|39.2|||<|0.0001|TWO_SIDED|97.5|26.3|52.1|||Cochran-Mantel-Haenszel||The estimate is calculated as EYLEA minus Laser.|||52.1|26.3|<0.0001
72579636|NCT01783886|144688333|SUPERIORITY_OR_OTHER||CMH adjusted difference|31.1|||<|0.0001|TWO_SIDED|97.5|19.2|43.0|||Cochran-Mantel-Haenszel||The estimate is calculated as EYLEA minus Laser.|||43.0|19.2|<0.0001
72579637|NCT01783886|144688333|SUPERIORITY_OR_OTHER||CMH adjusted difference|24.3|||<|0.0001|TWO_SIDED|97.5|12.6|35.9|||Cochran-Mantel-Haenszel||The estimate is calculated as EYLEA minus Laser.|||35.9|12.6|<0.0001
72545116|NCT01492582|144619195|SUPERIORITY||||||<|0.001|||||||Chi-squared, Corrected|||Injection site - Pain, any; Injection site - Swelling, any; Injection site - Erythema, any; Systemic - Nausea; Systemic - Fatigue Historical Healthy Population - As reported by Moreira et. al, 2016, Pediatrics, Table 5||||<0.001
72545117|NCT01492582|144619195|SUPERIORITY|||||||0.07|||||||Chi-squared, Corrected|||Systemic - Headache Historical Healthy Population - As reported by Moreira et. al, 2016, Pediatrics, Table 5||||0.07
72545118|NCT01492582|144619195|SUPERIORITY|||||||0.28|||||||Chi-squared, Corrected|||Systemic - Fever Historical Healthy Population - As reported by Moreira et. al, 2016, Pediatrics, Table 5||||0.28
72545119|NCT01492582|144619195|SUPERIORITY|||||||0.45|||||||Fisher Exact|||Systemic - Dizziness Historical Healthy Population - As reported by Moreira et. al, 2016, Pediatrics, Table 5||||0.45
72579638|NCT01783886|144688334|SUPERIORITY_OR_OTHER||CMH adjusted difference|39.1|||<|0.0001|TWO_SIDED|97.5|26.0|52.2|||Cochran-Mantel-Haenszel||The estimate is calculated as EYLEA minus Laser.|||52.2|26.0|<0.0001
72579639|NCT01783886|144688334|SUPERIORITY_OR_OTHER||CMH adjusted difference|40.6|||<|0.0001|TWO_SIDED|97.5|27.6|53.7|||Cochran-Mantel-Haenszel||The estimate is calculated as EYLEA minus Laser.|||53.7|27.6|<0.0001
72579640|NCT01783886|144688335|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-130.5|||<|0.0001|TWO_SIDED|97.5|-171.2|-89.9|||ANCOVA||LS mean difference from ANCOVA. The estimate is calculated as EYLEA minus Laser.|||-89.9|-171.2|<0.0001
72579641|NCT01783886|144688335|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-131.4|||<|0.0001|TWO_SIDED|97.5|-172.8|-89.9|||ANCOVA||LS mean difference from ANCOVA. The estimate is calculated as EYLEA minus Laser.|||-89.9|-172.8|<0.0001
72579642|NCT01783886|144688336|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.78||||0.0364|TWO_SIDED|97.5|-0.41|11.97|||ANCOVA||LS mean difference from ANCOVA. The estimate is calculated as EYLEA minus Laser.|||11.97|-0.41|0.0364
72579643|NCT01783886|144688336|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.87||||0.0113|TWO_SIDED|97.5|0.8|12.94|||ANCOVA||LS mean difference from ANCOVA. The estimate is calculated as EYLEA minus Laser.|||12.94|0.80|0.0113
72579644|NCT01783886|144688337|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.81||||0.2688|TWO_SIDED|97.5|-2.9|8.53|||ANCOVA||LS mean difference from ANCOVA. The estimate is calculated as EYLEA minus Laser.|||8.53|-2.90|0.2688
72579645|NCT01783886|144688337|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.01||||0.0009|TWO_SIDED|97.5|2.64|13.37|||ANCOVA||LS mean difference from ANCOVA. The estimate is calculated as EYLEA minus Laser.|||13.37|2.64|0.0009
72579646|NCT04542057|144688338|SUPERIORITY||LS mean difference|0.0941|STANDARD_ERROR_OF_MEAN|0.01501|<|0.0001|TWO_SIDED|95.0|0.0647|0.1236||The analysis of covariance (ANCOVA) model was used to model the change from baseline FEV1 to average FEV1 AUC0-12h with treatment, region, background medication strata and smoking strata as fixed effects and baseline FEV1 as covariate.|ANCOVA|||||0.1236|0.0647|<0.0001
72579647|NCT00825786|144688426|SUPERIORITY||Hazard Ratio (HR)|0.71||||0.14|TWO_SIDED|95.0|0.46|1.09|||Log Rank||group 2 vs. group 1 (sequential vs combined)|||1.09|0.46|0.14
72579648|NCT00825786|144688427|SUPERIORITY|||||||0.02|||||||Log Rank|||||||0.02
72579649|NCT00825786|144688428|SUPERIORITY|||||||0.66|||||||Log Rank|||||||0.66
72579650|NCT00825786|144688429|SUPERIORITY|||||||0.6|||||||ANCOVA|||||||0.60
72579651|NCT00825786|144688430|SUPERIORITY|||||||0.34|||||||ANCOVA|||||||0.34
72579652|NCT00825786|144688431|SUPERIORITY|||||||0.15|||||||Log Rank|||||||0.15
72579653|NCT00825786|144688432|SUPERIORITY|||||||0.88|||||||ANCOVA|||||||0.88
72579654|NCT00770328|144688433|SUPERIORITY|||||||0.0005|||||||Wilcoxon (Mann-Whitney)|||||||0.0005
72411528|NCT04666441|144331370|SUPERIORITY||Difference of LS Means|-0.45|STANDARD_ERROR_OF_MEAN|0.23||0.0515||95.0|-0.9|0.0|||Mixed Model for Repeated Measures (MMRM)|||Difference vs. Placebo, by Day 15 (log10 copies/mL)||0.00|-0.90|0.0515
72411529|NCT04666441|144331370|SUPERIORITY||Difference of LS Means|-0.31|STANDARD_ERROR_OF_MEAN|0.23||0.1864||95.0|-0.77|0.15|||Mixed Model for Repeated Measures (MMRM)|||Difference vs. Placebo, by Day 15 (log10 copies/mL)||0.15|-0.77|0.1864
72411530|NCT04666441|144331370|SUPERIORITY||Difference of LS Means|-0.25|STANDARD_ERROR_OF_MEAN|0.24||0.2866||95.0|-0.72|0.21|||Mixed Model for Repeated Measures (MMRM)|||Difference vs. Placebo, by Day 15 (log10 copies/mL)||0.21|-0.72|0.2866
72545120|NCT01172600|144619223|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.13||||0.84|TWO_SIDED|95.0|-1.43|1.17|||Regression, Linear|The analysis adjusted for VAS at baseline (before 1st block), number of epidural blocks received, and imbalanced baseline variables.|This is an intention- to-treat analysis. We assigned missing outcomes to 10 patients.|||1.17|-1.43|0.84
72545121|NCT01172600|144619223|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.03||||0.12|TWO_SIDED|95.0|-2.34|0.28|||Regression, Linear||This is a per-protocol analysis, using 68 patients with completed data.|||0.28|-2.34|0.12
72579655|NCT00770328|144688434|SUPERIORITY|||||||0.0114|||||||Wilcoxon (Mann-Whitney)|||||||0.0114
72579656|NCT03452943|144688437|OTHER||LS mean difference|-0.7||||0.692|TWO_SIDED|95.0|-4.1|2.8||Threshold for significance at 0.05 level.|Mixed Models Analysis|||||2.8|-4.1|0.692
72579657|NCT03541317|144688455|SUPERIORITY|A test of the null hypothesis that there is no difference between these two strategies on the sum of the average number of CBT sessions delivered to students by SPs over the four post-randomization phases during Stages 1 and 2|Difference in sum of means*|9.7||||0.63|TWO_SIDED|95.0|-30.03|49.4|||weighted least squares regression|Marginal means under each implementation strategy estimated after each of 4 post-randomization phases (NeCamp, Kilbourne, \& Almirall 2017)|\*Difference in the sum of the means estimated at each post-randomization phase.|||49.40|-30.03|0.63
72579658|NCT03541317|144688456|SUPERIORITY|A test of the null hypothesis that there is no difference between these two strategies on the sum of the average number of brief individual CBT sessions (\<15 min.) delivered to students by SPs over the four post-randomization phases occurring during Stages 1 and 2.|Difference in sum of means*|3.78||||0.72|TWO_SIDED|95.0|-16.88|24.44|||weighted least squares regression|Marginal means under each embedded implementation strategy estimated after each of 4 post-randomization phases (NeCamp, Kilbourne \& Almirall 2017)|\*Difference in the sum of the means estimated at each post-randomization phase|||24.44|-16.88|0.72
72411531|NCT04666441|144331370|SUPERIORITY||Difference of LS Means|-0.11|STANDARD_ERROR_OF_MEAN|0.24||0.647||95.0|-0.58|0.36|||Mixed Model for Repeated Measures (MMRM)|||Difference vs. Placebo, by Day 15 (log10 copies/mL)||0.36|-0.58|0.6470
72411532|NCT04666441|144331370|SUPERIORITY||Difference of LS Means|-0.51|STANDARD_ERROR_OF_MEAN|0.23||0.028||95.0|-0.97|-0.06|||Mixed Model for Repeated Measures (MMRM)|||Difference vs. Placebo, by Day 15 (log10 copies/mL)||-0.06|-0.97|0.0280
72411533|NCT04666441|144331370|SUPERIORITY||Difference of LS Means|-0.39|STANDARD_ERROR_OF_MEAN|0.23||0.0854||95.0|-0.84|0.05|||Mixed Models Analysis|||Difference vs. Placebo, by Day 15 (log10 copies/mL)||0.05|-0.84|0.0854
72579659|NCT03541317|144688457|SUPERIORITY|A test of the null hypothesis that there is no difference between these two strategies on the sum of the average number of brief individual CBT sessions (\>15 min.) delivered to students by SPs over the four post-randomization phases occurring during Stages 1 and 2.|Difference in sum of means*|7.85||||0.46|TWO_SIDED|95.0|-13.2|28.91|||Weighted Least Squares Regression|Marginal means under each embedded implementation strategy estimated after each of 4 post-randomization phases (NeCamp, Kilbourne \& Almirall 2017).|Difference in the sum of the means estimated at each post-randomization phase|||28.91|-13.20|0.46
72579660|NCT03541317|144688458|SUPERIORITY||Difference in sum of means*|-0.66||||0.87|TWO_SIDED|95.0|-8.49|7.16|||Weighted Least Squares Regression|Marginal means under each embedded implementation strategy estimated after each of 4 post-randomization phases (NeCamp, Kilbourne \& Almirall 2017).|Difference in the sum of the means estimated at each post-randomization phase|A test of the null hypothesis that there is no difference between these two strategies on the sum of the average number of group CBT sessions delivered to students by SPs over the four post-randomization phase occurring during Stages 1 and 2.||7.16|-8.49|0.87
72411534|NCT04666441|144331370|SUPERIORITY||Difference of LS Means|-0.31|STANDARD_ERROR_OF_MEAN|0.19||0.1078|TWO_SIDED|95.0|-0.69|0.07|||Mixed Model for Repeated Measures (MMRM)|||Difference vs. Placebo, by Day 22 (log10 copies/mL)||0.07|-0.69|0.1078
72411535|NCT04666441|144331370|SUPERIORITY||Difference of LS Means|-0.24|STANDARD_ERROR_OF_MEAN|0.19||0.2235||95.0|-0.62|0.14|||Mixed Model for Repeated Measures (MMRM)|||Difference vs. Placebo, by Day 22 (log10 copies/mL)||0.14|-0.62|0.2235
72411536|NCT04666441|144331370|SUPERIORITY||Difference of LS Means|-0.29|STANDARD_ERROR_OF_MEAN|0.2||0.1369||95.0|-0.68|0.09|||Mixed Model for Repeated Measures (MMRM)|||Difference vs. Placebo, by Day 22 (log10 copies/mL)||0.09|-0.68|0.1369
72411537|NCT04666441|144331370|SUPERIORITY||Difference of LS Means|-0.09|STANDARD_ERROR_OF_MEAN|0.2||0.661||95.0|-0.48|0.31|||Mixed Model for Repeated Measures (MMRM)|||Difference vs. Placebo, by Day 22 (log10 copies/mL)||0.31|-0.48|0.6610
72411538|NCT04666441|144331370|SUPERIORITY||Difference of LS Means|-0.43|STANDARD_ERROR_OF_MEAN|0.19||0.0284||95.0|-0.81|-0.05|||Mixed Model for Repeated Measures (MMRM)|||Difference vs. Placebo, by Day 22 (log10 copies/mL)||-0.05|-0.81|0.0284
72545122|NCT01172600|144619224|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.29||||0.63|TWO_SIDED|98.3|-1.8|1.21|||Mixed Models Analysis|Mixed model with repeated measures, adjusting for VAS pain score at baseline, number of epidural blocks received, and imbalanced baseline variables.|This analysis was per-protocol, using only patients with completed data.|||1.21|-1.80|0.63
72579661|NCT02593110|144688493|SUPERIORITY||Mean Difference (Final Values)|-24.41||||0.1107|TWO_SIDED|95.0|-54.59|5.78|||ANCOVA|||||5.78|-54.59|0.1107
72411539|NCT04666441|144331370|SUPERIORITY||Difference of LS Means|-0.33|STANDARD_ERROR_OF_MEAN|0.19||0.08||95.0|-0.71|0.04|||Mixed Model for Repeated Measures (MMRM)|||Difference vs. Placebo, by Day 22 (log10 copies/mL)||0.04|-0.71|0.0800
72411540|NCT02752048|144331389|OTHER|Change in time to rise from the floor from baseline to Week 24 were calculated to evaluate|Mean Difference (Final Values)|-1.378||||0.596|TWO_SIDED|95.0|-6.757|4.0|||t-test, 2 sided|||||4.000|-6.757|0.596
72411541|NCT02752048|144331389|OTHER|Change in time to rise from the floor from baseline to Week 24 were calculated to evaluate|Mean Difference (Final Values)|1.349||||0.433|TWO_SIDED|95.0|-2.22|4.918|||t-test, 2 sided|||||4.918|-2.220|0.433
72411542|NCT02752048|144331390|OTHER|Change in 10-m walk/run test from baseline to Week 24 were calculated to evaluate|Mean Difference (Final Values)|-0.484||||0.382|TWO_SIDED|95.0|-1.618|0.65|||t-test, 2 sided|||||0.650|-1.618|0.382
72579662|NCT02593110|144688493|SUPERIORITY||Mean Difference (Final Values)|9.78||||0.5378|TWO_SIDED|95.0|-21.84|41.39|||ANCOVA|||||41.39|-21.84|0.5378
72579663|NCT02593110|144688493|SUPERIORITY||Mean Difference (Final Values)|0.71||||0.956|TWO_SIDED|95.0|-24.96|26.38|||ANCOVA|||||26.38|-24.96|0.9560
72579664|NCT02593110|144688494|SUPERIORITY||Mean Difference (Final Values)|31.35||||0.6121|TWO_SIDED|95.0|-92.42|155.12|||ANCOVA|||||155.12|-92.42|0.6121
72579665|NCT02593110|144688494|SUPERIORITY||Mean Difference (Final Values)|141.78||||0.0116|TWO_SIDED|95.0|33.14|250.42|||ANCOVA|||||250.42|33.14|0.0116
72579666|NCT02593110|144688494|SUPERIORITY||Mean Difference (Final Values)|-14.75||||0.8146|TWO_SIDED|95.0|-140.89|111.39|||ANCOVA|||||111.39|-140.89|0.8146
72579667|NCT02593110|144688495|SUPERIORITY||Mean Difference (Final Values)|0.92||||0.8755|TWO_SIDED|95.0|-10.84|12.68|||ANCOVA|||||12.68|-10.84|0.8755
72579668|NCT02593110|144688495|SUPERIORITY||Mean Difference (Final Values)|2.44||||0.7651|TWO_SIDED|95.0|-13.83|18.7|||ANCOVA|||||18.70|-13.83|0.7651
72579669|NCT02593110|144688495|SUPERIORITY||Mean Difference (Final Values)|6.88||||0.3776|TWO_SIDED|95.0|-8.65|22.41|||ANCOVA|||||22.41|-8.65|0.3776
72579670|NCT02593110|144688496|SUPERIORITY||Mean Difference (Final Values)|-8.06||||0.1782|TWO_SIDED|95.0|-19.91|3.79|||ANCOVA|||||3.79|-19.91|0.1782
72579671|NCT02593110|144688496|SUPERIORITY||Mean Difference (Final Values)|-5.27||||0.3555|TWO_SIDED|95.0|-16.61|6.07|||ANCOVA|||||6.07|-16.61|0.3555
72579672|NCT02593110|144688496|SUPERIORITY||Mean Difference (Final Values)|5.75||||0.3294|TWO_SIDED|95.0|-5.99|17.49|||ANCOVA|||||17.49|-5.99|0.3294
72579673|NCT02593110|144688497|SUPERIORITY||Mean Difference (Final Values)|-8.72||||0.1569|TWO_SIDED|95.0|-20.91|3.47|||ANCOVA|||||3.47|-20.91|0.1569
72579674|NCT02593110|144688497|SUPERIORITY||Mean Difference (Final Values)|-2.07||||0.7692|TWO_SIDED|95.0|-16.16|12.02|||ANCOVA|||||12.02|-16.16|0.7692
72579675|NCT02593110|144688497|SUPERIORITY||Mean Difference (Final Values)|3.09||||0.6306|TWO_SIDED|95.0|-9.74|15.91|||ANCOVA|||||15.91|-9.74|0.6306
72579676|NCT02593110|144688498|SUPERIORITY||Mean Difference (Final Values)|-7.86||||0.3542|TWO_SIDED|95.0|-24.74|9.02|||ANCOVA|||||9.02|-24.74|0.3542
72579677|NCT02593110|144688498|SUPERIORITY||Mean Difference (Final Values)|-0.64||||0.9417|TWO_SIDED|95.0|-17.98|16.71|||ANCOVA|||||16.71|-17.98|0.9417
72579678|NCT02593110|144688498|SUPERIORITY||Mean Difference (Final Values)|5.45||||0.4508|TWO_SIDED|95.0|-8.96|19.86|||ANCOVA|||||19.86|-8.96|0.4508
72579679|NCT04604795|144688528|OTHER||Ratio of geometric mean|1.05|||||TWO_SIDED|90.0|0.833|1.331|||||Log transformed Cmax was analyzed using a mixed model with fixed effects for regimen and period, and participants as random effect.|||1.331|0.833|
72579680|NCT04604795|144688528|OTHER||Ratio of geometric mean|6.45|||||TWO_SIDED|90.0|4.916|8.474|||||Log transformed Cmax was analyzed using a mixed model with regimen, period, and regimen by period as fixed effects and participants as random effect.|||8.474|4.916|
72579681|NCT04604795|144688537|OTHER||Ratio of geometric mean|1.53|||||TWO_SIDED|90.0|1.268|1.847|||||AUC(0-inf) was analyzed using a mixed model with fixed effects for regimen and period, and participants as random effect.|||1.847|1.268|
72579682|NCT04604795|144688537|OTHER||Ratio of geometric mean|12.51|||||TWO_SIDED|90.0|10.141|15.423|||||Log transformed AUC(0-inf) was analyzed using a mixed model with regimen, period, and regimen by period as fixed effects and participants as random effect.|||15.423|10.141|
72579683|NCT04604795|144688574|OTHER||Ratio of geometric mean|0.47|||||TWO_SIDED|90.0|0.318|0.693|||||Day 5 (High fat meal) versus (vs) Day 3 (fasted)|||0.693|0.318|
72579684|NCT04604795|144688574|OTHER||Ratio of geometric mean|0.6|||||TWO_SIDED|90.0|0.405|0.882|||||Day 7 (Standard meal) vs Day 3 (fasted)|||0.882|0.405|
72579685|NCT04604795|144688574|OTHER||Ratio of geometric mean|0.29|||||TWO_SIDED|90.0|0.194|0.427|||||Day 5 (High fat meal) vs Day 3 (fasted)|||0.427|0.194|
72579686|NCT04604795|144688574|OTHER||Ratio of geometric mean|0.43|||||TWO_SIDED|90.0|0.292|0.643|||||Day 7 (Standard meal) vs Day 3 (fasted)|||0.643|0.292|
72579687|NCT04604795|144688574|OTHER||Ratio of geometric mean|0.42|||||TWO_SIDED|90.0|0.28|0.617|||||Day 5 (High fat meal) vs Day 3 (fasted)|||0.617|0.280|
72579688|NCT04604795|144688574|OTHER||Ratio of geometric mean|0.61|||||TWO_SIDED|90.0|0.41|0.903|||||Day 7 (Standard meal) vs Day 3 (fasted)|||0.903|0.410|
72579689|NCT04604795|144688576|OTHER||Ratio of geometric mean|1.02|||||TWO_SIDED|90.0|0.867|1.205|||||Day 5 (High fat meal) vs Day 3 (fasted)|||1.205|0.867|
72579690|NCT04604795|144688576|OTHER||Ratio of geometric mean|1.11|||||TWO_SIDED|90.0|0.941|1.308|||||Day 7 (Standard meal) vs Day 3 (fasted)|||1.308|0.941|
72579691|NCT04604795|144688576|OTHER||Ratio of geometric mean|0.79|||||TWO_SIDED|90.0|0.671|0.933|||||Day 5 (High fat meal) vs Day 3 (fasted)|||0.933|0.671|
72579692|NCT04604795|144688576|OTHER||Ratio of geometric mean|0.85|||||TWO_SIDED|90.0|0.724|1.007|||||Day 7 (Standard meal) vs Day 3 (fasted)|||1.007|0.724|
72579693|NCT04604795|144688576|OTHER||Ratio of geometric mean|0.84|||||TWO_SIDED|90.0|0.713|0.992|||||Day 5 (High fat meal) vs Day 3 (fasted)|||0.992|0.713|
72579694|NCT04604795|144688576|OTHER||Ratio of geometric mean|0.99|||||TWO_SIDED|90.0|0.837|1.165|||||Day 7 (Standard meal) vs Day 3 (fasted)|||1.165|0.837|
72579695|NCT02096744|144688595|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratios of the geometric means Catapres-TTS-3(Oppanol/Vistanex) using an acceptance range of 80.00 to 125.00%.|Adjusted Geometric Mean ratio|102.33|STANDARD_ERROR_OF_MEAN|19.0|<|0.0001|TWO_SIDED|90.0|95.74|109.37|||ANOVA|ANOVA on the logarithmic scale including effects for 'Group', 'sequence', 'subjects within sequences', 'period', and 'treatment'.|"The estimated value is actually the ratio of Catapres-TTS-3 with Oppanol and Catapres-TTS-3 with Vistanex.~The value in parameter dispersion type and dispersion value is actually the intra-individual gCV."|||109.37|95.74|<0.0001
72411543|NCT02752048|144331390|OTHER|Change in 10-m walk/run test from baseline to Week 24 were calculated to evaluate|Mean Difference (Final Values)|-0.397||||0.501|TWO_SIDED|95.0|-1.61|0.817|||t-test, 2 sided|||||0.817|-1.610|0.501
72579696|NCT02096744|144688596|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratios of the geometric means Catapres-TTS-3(Oppanol/Vistanex) using an acceptance range of 80.00 to 125.00%.|Adjusted Geometric Means ratio|104.25|STANDARD_ERROR_OF_MEAN|16.6|<|0.0001|TWO_SIDED|90.0|98.367|110.487|||ANOVA|ANOVA on the logarithmic scale including effects for 'Group', 'sequence', 'subjects within sequences', 'period', and 'treatment'.|"The estimated value is actually the ratio of Catapres-TTS-3 with Oppanol and Catapres-TTS-3 with Vistanex.~The value in parameter dispersion type and dispersion value is actually the intra-individual gCV."|||110.487|98.367|<0.0001
72579697|NCT02096744|144688597|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratios of the geometric means Catapres-TTS-3(Oppanol/Vistanex) using an acceptance range of 80.00 to 125.00%.|Adjusted Geometric Means ratio|102.78|STANDARD_ERROR_OF_MEAN|15.8|<|0.0001|TWO_SIDED|90.0|97.25|108.63|||ANOVA|ANOVA on the logarithmic scale including effects for 'Group', 'sequence', 'subjects within sequences', 'period', and 'treatment'.|"The estimated value is actually the ratio of Catapres-TTS-3 with Oppanol and Catapres-TTS-3 with Vistanex.~The value in parameter dispersion type and dispersion value is actually the intra-individual gCV."|||108.63|97.25|<0.0001
72579698|NCT02096744|144688598|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratios of the geometric means Catapres-TTS-3(Oppanol/Vistanex) using an acceptance range of 80.00 to 125.00%.|Adjusted Geometric Means ratio|104.04|STANDARD_ERROR_OF_MEAN|16.7|<|0.0001|TWO_SIDED|90.0|98.148|110.294|||ANOVA|ANOVA on the logarithmic scale including effects for 'Group','sequence', 'subjects within sequences', 'period', and 'treatment'.|"The estimated value is actually the ratio of Catapres-TTS-3 with Oppanol and Catapres-TTS-3 with Vistanex.~The value in parameter dispersion type and dispersion value is actually the intra-individual gCV."|||110.294|98.148|<0.0001
72579699|NCT03048552|144688612|SUPERIORITY|||||||0.148|||||||Fisher Exact|||||||0.148
72579700|NCT03048552|144688613|SUPERIORITY||||||<|0.01|||||||Fisher Exact|||||||<0.01
72579701|NCT03048552|144688614|SUPERIORITY|||||||0.818|||||||Fisher Exact|||||||0.818
72579702|NCT03048552|144688616|SUPERIORITY|||||||0.625|||||||Fisher Exact|||||||0.625
72579703|NCT03172494|144688617|NON_INFERIORITY|Non-inferiority of insulin degludec/liraglutide versus insulin degludec was considered as confirmed if the 95% confidence interval (CI) for the mean treatment difference lied entirely below 0.4%. Non-inferiority was investigated on the FAS.|Mean treatment difference|-0.59|||<|0.0001|TWO_SIDED|95.0|-0.73|-0.46|||ANCOVA|||The change from baseline in HbA1c after 26 weeks of treatment was analysed using an analysis of covariance (ANCOVA) model with treatment and previous oral anti-diabetic (OAD) treatment as fixed factors and baseline HbA1c as covariate. Missing values were imputed by last observation carried forward (LOCF).||-0.46|-0.73|<0.0001
72411544|NCT02752048|144331391|OTHER|Change in time to up and go from baseline to Week 24 were calculated to evaluate|Mean Difference (Final Values)|-0.533||||0.549|TWO_SIDED|95.0|-2.363|1.298|||t-test, 2 sided|||||1.298|-2.363|0.549
72579704|NCT03172494|144688617|SUPERIORITY||Mean treatment difference|-0.63|||<|0.0001|TWO_SIDED|95.0|-0.76|-0.49|||ANCOVA|||The change from baseline in HbA1c after 26 weeks of treatment was analysed using an ANCOVA model with treatment and previous OAD treatment as fixed factors and baseline HbA1c as covariate. Missing values were imputed by LOCF.||-0.49|-0.76|<0.0001
72579705|NCT03086551|144688679|OTHER||Effect Size - Cohen's d|0.2|||||TWO_SIDED||||||||Cohen's d was calculated as time to complete the sequence at the pre-baseline assessment minus the time it took to complete the sequence at the post-intervention assessment. The denominator reflected pooled variance.|Magnitude of change in sequence completion time from pre-baseline to post-intervention for the Active arm. Cohen's d was calculated as a measure of effect size.||||
72579706|NCT03086551|144688679|OTHER||Effect Size - Cohen's d|0.69|||||TWO_SIDED||||||||Cohen's d was calculated as time to complete the sequence at the pre-baseline assessment minus the time it took to complete the sequence at the post-intervention assessment. The denominator reflected pooled variance.|Magnitude of change in sequence completion time from pre-baseline to post-intervention for the Sham arm. Cohen's d was calculated as a measure of effect size.||||
72411545|NCT02752048|144331391|OTHER|Change in time to up and go from baseline to Week 24 were calculated to evaluate|Mean Difference (Final Values)|-0.225||||0.767|TWO_SIDED|95.0|-1.801|1.351|||t-test, 2 sided|||||1.351|-1.801|0.767
72579707|NCT03086551|144688679|OTHER|Cohen's d effect size was calculated to compare the magnitude of change in time to complete the movement sequence from pre-baseline to post-intervention across the Active and Sham arms.|Effect Size - Cohen's d|-0.8|||||TWO_SIDED||||||||Cohen's d was calculated as the change from pre- to post-intervention for the Active arm minus change from pre- to post-intervention for the Sham arm. The denominator reflected pooled variance.|||||
72579708|NCT03086551|144688680|OTHER||Effect Size - Cohen's d|-0.08|||||TWO_SIDED||||||||Cohen's d was calculated as aggregate time to complete all elements at the pre-baseline assessment minus the aggregate time it took to complete all elements at the post-intervention assessment. The denominator reflected pooled variance.|The magnitude of transfer of the task specific practice to functional activities of daily live for the stroke affected limb was assessed by calculating the magnitude of change (Cohen's d) in time to complete the activities of the Jebsen-Taylor Hand Function Test from pre-baseline to post-intervention in the Active arm.||||
72579709|NCT03086551|144688680|OTHER||Effect Size - Cohen's d|0.5|||||TWO_SIDED||||||||Cohen's d was calculated as aggregate time to complete all elements at the pre-baseline assessment minus the aggregate time it took to complete all elements at the post-intervention assessment. The denominator reflected pooled variance.|The magnitude of transfer of the task specific practice to functional activities of daily live for the stroke affected limb was assessed by calculating the magnitude of change (Cohen's d) in time to complete the activities of the Jebsen-Taylor Hand Function Test from pre-baseline to post-intervention in the Sham arm.||||
72579710|NCT03086551|144688680|OTHER||Effect Size - Cohen's d|-1.84|||||TWO_SIDED||||||||Cohen's d was calculated as the change from pre- to post-intervention for the Active arm minus the change from pre- to post-intervention for the Sham arm. The denominator reflected pooled variance.|Comparison across study arm of the magnitude of improvement in aggregate time to complete all elements of the Jebsen-Taylor Hand Function Test for the stroke affected limb. Cohen's d was calculated as a measure of effect size.||||
72579711|NCT03086551|144688680|OTHER||Effect Size - Cohen's d|0.38|||||TWO_SIDED||||||||Cohen's d was calculated as aggregate time to complete all elements at the pre-baseline assessment minus the aggregate time it took to complete all elements at the post-intervention assessment. The denominator reflected pooled variance.|The magnitude of transfer of the task specific practice to functional activities of daily live for the non-stroke affected limb was assessed by calculating the magnitude of change (Cohen's d) in time to complete the activities of the Jebsen-Taylor Hand Function Test from pre-baseline to post-intervention in the Active arm.||||
72579712|NCT03086551|144688680|OTHER||Effect Size - Cohen's d|0.08|||||TWO_SIDED||||||||Cohen's d was calculated as aggregate time to complete all elements at the pre-baseline assessment minus the aggregate time it took to complete all elements at the post-intervention assessment. The denominator reflected pooled variance.|The magnitude of transfer of the task specific practice to functional activities of daily live for the non-stroke affected limb was assessed by calculating the magnitude of change (Cohen's d) in time to complete the activities of the Jebsen-Taylor Hand Function Test from pre-baseline to post-intervention in the Sham arm.||||
72579713|NCT03086551|144688680|OTHER||Effect Size - Cohen's d|0.38|||||TWO_SIDED||||||||Cohen's d was calculated as the change from pre- to post-intervention for the Active arm minus the change from pre- to post-intervention for the Sham arm. The denominator reflected pooled variance.|Comparison across study arm of the magnitude of improvement in aggregate time to complete all elements of the Jebsen-Taylor Hand Function Test for the non-stroke affected limb. Cohen's d was calculated as a measure of effect size.||||
72545123|NCT01172600|144619225|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.11||||0.16|TWO_SIDED|98.3|-3.05|0.82|||Mixed Models Analysis|Mixed model with repeated measures, adjusting for VAS pain score at baseline, number of epidural blocks received, and imbalanced baseline variables.|This analysis was per-protocol, using only patients with completed data.|||0.82|-3.05|0.16
72545124|NCT03907280|144619236|OTHER|Absolute bioavailability comparison|Ratio of the geometric means (T1/R) [%]|0.5|STANDARD_ERROR_OF_MEAN|1.15|||TWO_SIDED|90.0|0.39|0.63|||Mixed Models Analysis||The standard error of the mean is actually the geometric standard error.|Exploratory trial, no formal hypotheses were tested. Analysis of variance (ANOVA) on the logarithmic scale including effects for treatment sequence ('fixed effect'), subjects nested within treatment sequences ('random effect'), and treatment ('fixed effect').||0.63|0.39|
72411546|NCT00132769|144331392|SUPERIORITY_OR_OTHER||Difference in LS Mean|1.48||||0.278|TWO_SIDED|95.0|-1.21|4.18|||ANCOVA|||||4.18|-1.21|0.278
72411547|NCT00132769|144331393|SUPERIORITY_OR_OTHER||Difference in Percent|-5.66||||0.543|TWO_SIDED|95.0|-24.45|13.13|||Cochran-Mantel-Haenszel|||||13.13|-24.45|0.543
72545125|NCT03907280|144619236|OTHER|Absolute bioavailability comparison|Ratio of the geometric means (T2/R) [%]|40.26|STANDARD_ERROR_OF_MEAN|1.15|||TWO_SIDED|90.0|31.68|51.15|||Mixed Models Analysis||The standard error of the mean is actually the geometric standard error.|Exploratory trial, no formal hypotheses were tested. Analysis of variance (ANOVA) on the logarithmic scale including effects for treatment sequence ('fixed effect'), subjects nested within treatment sequences ('random effect'), and treatment ('fixed effect').||51.15|31.68|
72545126|NCT03907280|144619236|OTHER|Absolute bioavailability comparison|Ratio of the geometric means (T3/R) [%]|40.24|STANDARD_ERROR_OF_MEAN|1.15|||TWO_SIDED|90.0|31.86|50.83|||Mixed Models Analysis|The standard error of the mean is actually the geometric standard error.||Exploratory trial, no formal hypotheses were tested. Analysis of variance (ANOVA) on the logarithmic scale including effects for treatment sequence ('fixed effect'), subjects nested within treatment sequences ('random effect'), and treatment ('fixed effect').||50.83|31.86|
72545127|NCT00909727|144619237|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.5|STANDARD_ERROR_OF_MEAN|2.9|<|0.0001|TWO_SIDED|95.0|6.6|18.3||The primary endpoint and key secondary endpoints were tested in sequence. test 1: primary (α=0.05); test 2: using Hochberg's step-up procedure on weight (Wk 24) and sweat chloride (Wk 24)(α=0.05); test 3: CFQ-R respiratory domain score (Wk 24).|Mixed Models Analysis|Denominator degrees of freedom were estimated using the Kenward-Roger approximation. No imputation of missing data was done.||The primary analysis for the primary efficacy variable was based on a Mixed-Effects Model for Repeated Measures (MMRM). The model included absolute change from baseline in percent predicted forced expiratory volume in 1 second (FEV1) as the dependent variable, treatment (ivacaftor versus placebo) and visit (Day 15, Week 8, Week 16, and Week 24) as fixed effects, and subject as a random effect, with adjustment for the continuous baseline value of percent predicted FEV1.||18.3|6.6|<0.0001
72545128|NCT00909727|144619238|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.0|STANDARD_ERROR_OF_MEAN|2.7||0.0006|TWO_SIDED|95.0|4.5|15.5||There was no adjustment for multiple comparisons.|Mixed Models Analysis|Denominator degrees of freedom were estimated using the Kenward-Roger approximation. no imputation of missing data was done.||Analysis for this variable was similar to that of the primary analysis of the primary efficacy endpoint, a Mixed-Effects Model for Repeated Measures (MMRM). Estimates were obtained from MMRM with dependent variable absolute change from baseline, fixed effects for categorical visit \& treatment group, \& adjustment for the continuous baseline value of percent predicted FEV1, using unstructured covariance matrix.||15.5|4.5|0.0006
72545129|NCT00909727|144619239|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.1|STANDARD_ERROR_OF_MEAN|3.7||0.1092|TWO_SIDED|95.0|-1.4|13.5||The primary endpoint and key secondary endpoints were tested in sequence. test 1: primary (α=0.05); test 2: using Hochberg's step-up procedure on weight (Wk 24) and sweat chloride (Wk 24)(α=0.05); test 3: CFQ-R respiratory domain score (Wk 24).|Mixed Models Analysis|||Through Week 24: Analysis for this variable was similar to that of the primary analysis of the primary efficacy endpoint, a Mixed-Effects Model for Repeated Measures (MMRM), with the addition of the baseline domain score as a covariate.||13.5|-1.4|0.1092
72545130|NCT00909727|144619239|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.1|STANDARD_ERROR_OF_MEAN|3.3||0.1354|TWO_SIDED|95.0|-1.6|11.8||There was no adjustment for multiple comparisons.|Mixed Models Analysis|||Through Week 48: Analysis for this variable was similar to that of the primary analysis of the primary efficacy endpoint, a Mixed-Effects Model for Repeated Measures (MMRM), with the addition of the baseline domain score as a covariate.||11.8|-1.6|0.1354
72545131|NCT00909727|144619240|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-54.3|STANDARD_ERROR_OF_MEAN|3.7|<|0.0001|TWO_SIDED|95.0|-61.8|-46.8||The primary endpoint and key secondary endpoints were tested in sequence. test 1: primary (α=0.05); test 2: using Hochberg's step-up procedure on weight (Wk 24) and sweat chloride (Wk 24)(α=0.05); test 3: CFQ-R respiratory domain score (Wk 24).|Mixed Models Analysis|||Through Week 24: Analysis for this variable was similar to that of the primary analysis of the primary efficacy endpoint. Estimates were from Mixed-Effects Model for Repeated Measures (MMRM) with dependent variable absolute change from baseline, fixed effects for categorical visit and treatment group, and adjustment for continuous baseline value for sweat chloride and percent predicted forced expiratory volume in 1 second (FEV1), using unstructured covariance matrix.||-46.8|-61.8|<0.0001
72545132|NCT00909727|144619240|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-53.5|STANDARD_ERROR_OF_MEAN|3.7|<|0.0001|TWO_SIDED|95.0|-60.9|-46.0||There was no adjustment for multiple comparisons.|Mixed Models Analysis|||Through Week 48: Analysis for this variable was similar to that of the primary analysis of the primary efficacy endpoint. Estimates were from Mixed-Effects Model for Repeated Measures (MMRM) with dependent variable absolute change from baseline, fixed effects for categorical visit and treatment group, and adjustment for continuous baseline value for sweat chloride and percent predicted forced expiratory volume in 1 second (FEV1), using unstructured covariance matrix.||-46.0|-60.9|<0.0001
72545133|NCT00909727|144619241|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.9|STANDARD_ERROR_OF_MEAN|0.5||0.0004|TWO_SIDED|95.0|0.9|2.9||The primary endpoint and key secondary endpoints were tested in sequence. test 1: primary (α=0.05); test 2: using Hochberg's step-up procedure on weight (Wk 24) and sweat chloride (Wk 24)(α=0.05); test 3: CFQ-R respiratory domain score (Wk 24).|Mixed Models Analysis|||At Week 24: Analysis for this variable was based on a Linear Mixed Effect (LME) model with dependent variable weight; treatment as a fixed effect; and intercept, visit, and treatment by visit interaction as random effects, with adjustment for baseline percent predicted forced expiratory volume in 1 second (FEV1) severity.||2.9|0.9|0.0004
72579714|NCT03086551|144688681|OTHER||Effect Size - Cohen's d|-0.86|||||TWO_SIDED||||||||Cohen's d was calculated as the change from pre- to immediately post-stimulation (within the same session) for the Active arm minus the change from pre- to immediately post-stimulation for the Sham arm. The denominator reflected pooled variance.|The immediate effect of continuous theta burst stimulation over dorsolateral prefrontal cortex prior to practice was assessed by determining the magnitude of the effect of Active stimulation from pre-intervention to immediately post-intervention in Session 1 of the intervention. Cohen's d was used to derive effect size. The Sham stimulation change was used as the control.||||
72411548|NCT00132769|144331400|SUPERIORITY_OR_OTHER||LS mean ratio between treatments|0.84||||0.225|TWO_SIDED|95.0|0.63|1.12|||ANCOVA|||||1.12|0.63|0.225
72411549|NCT02670629|144331403|SUPERIORITY_OR_OTHER_LEGACY|||||||0.003|TWO_SIDED||||||Chi-squared|||||||0.003
72411550|NCT03285477|144331406|SUPERIORITY||||||<|0.0001||||||P-value threshold for statistical significance was 0.5%|Cochran-Mantel-Haenszel|||Statistical significance in the study for Day 57 complete clearance rate was analyzed using a Cochran-Mantel-Haenszel model controlling for treatment location (face or scalp) and treatment group (Placebo versus KX2-391 Ointment 1%).||||<0.0001
72411551|NCT03285477|144331407|SUPERIORITY||||||<|0.0001||||||P-value threshold for statistical significance was 0.5%|Cochran-Mantel-Haenszel|||Statistical significance in the study for Day 57 partial clearance rate was analyzed using a Cochran-Mantel-Haenszel model controlling for treatment location (face or scalp) and treatment group (Placebo versus KX2-391 Ointment 1%).||||<0.0001
72411552|NCT01085318|144331418|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|864.1||||0.061|||||||Wilcoxon (Mann-Whitney)|||||||0.061
72411553|NCT01085318|144331419|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|644.99|||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
72411554|NCT04286594|144331422|OTHER|Change in single group over time|Mean Difference (Final Values)|11.667|STANDARD_DEVIATION|5.051|<|0.001|TWO_SIDED|95.0|8.457|14.876|||t-test, 1 sided|||||14.876|8.457|<0.001
72411555|NCT03047447|144331462|OTHER|||||||0.001||||||Change over time from week 0 to week 10 with HgA1c for experimental ketogenic group vs.control exercise and non-exercise groups.|ANOVA|||||||0.001
72545134|NCT00909727|144619241|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.8|STANDARD_ERROR_OF_MEAN|0.7||0.0002|TWO_SIDED|95.0|1.3|4.2||P-value is for the treatment effect at Week 48 (obtained as a linear contrast of treatment at Day 336). There was no adjustment for multiple comparisons.|Mixed Models Analysis|||At Week 48: Analysis for this variable was based on a Linear Mixed Effect (LME) model with random intercept and random slope, treatment as a fixed effect, and visit (days on study) and treatment by visit interaction as random effects, with adjustment for categorical baseline percent predicted forced expiratory volume in 1 second (FEV1) severity.||4.2|1.3|0.0002
72411556|NCT03047447|144331463|OTHER|||||||0.001|||||||ANOVA|Change over time from week 0 to week 10 with weight for experimental ketogenic group vs.control exercise and non-exercise groups.||||||0.001
72411557|NCT03047447|144331464|OTHER|||||||0.001|||||||ANOVA|Change over time from week 0 to week 10 with BMI for experimental ketogenic group vs.control exercise and non-exercise groups.||||||0.001
72411558|NCT03047447|144331465|OTHER|||||||0.001|||||||ANOVA|Change over time from week 0 to week 10 with body fat mass for experimental ketogenic group vs.control exercise and non-exercise groups.||||||0.001
72411559|NCT03047447|144331466|OTHER|||||||0.001|||||||ANOVA|Change over time from week 0 to week 10 with blood ketones for experimental ketogenic group vs.control exercise and non-exercise groups.||||||0.001
72411560|NCT01073618|144331480|SUPERIORITY_OR_OTHER||Efficacy rate (percent)|75.15|||||TWO_SIDED|95.0|71.36|78.94|||Normal approximation to binomial||Confidence Interval (CI) by normal approximation to binomial.|Efficacy Rate (treatment effective) = Percentage of evaluable participants with clinical response of cure or improvement||78.94|71.36|
72411561|NCT00466193|144331486|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value is for treatment|ANCOVA|||||||<0.001
72411562|NCT00466193|144331488|SUPERIORITY_OR_OTHER|||||||0.006||95.0||||p-value is for treatment|ANCOVA|||||||0.006
72411563|NCT00466193|144331491|SUPERIORITY_OR_OTHER|||||||0.0041||95.0||||P-value is for treatment|ANCOVA|||||||0.0041
72411564|NCT01075074|144331531|SUPERIORITY_OR_OTHER|||||||0.006||||||Corrected for 6 comparisons.|Kruskal-Wallis|||A sample size of 23 subjects per group was estimated to achieve 80% power to detect a 10 point difference in the aggregated QOR40 score for the 3 study groups to be compared assuming an overall standard deviation of 12.||||0.006
72411565|NCT01075074|144331531|SUPERIORITY_OR_OTHER||Median Difference (Net)|16.0||||0.03|TWO_SIDED|95.0|1.0|30.0|||Wilcoxon (Mann-Whitney)|||||30|1|0.03
72411566|NCT01075074|144331531|SUPERIORITY_OR_OTHER||Median Difference (Net)|17.0||||0.01|TWO_SIDED|95.0|2.0|31.0|||Wilcoxon (Mann-Whitney)|||||31|2|0.01
72411567|NCT01075074|144331531|SUPERIORITY_OR_OTHER||Median Difference (Net)|1.0||||1|TWO_SIDED|95.0|-16.0|12.0|||Wilcoxon (Mann-Whitney)|||||12|-16|1.0
72411568|NCT01075074|144331532|SUPERIORITY_OR_OTHER|||||||0.0003||95.0||||P values is corrected for 6 comparisons|Kruskal-Wallis|||||||0.0003
72411569|NCT01075074|144331532|SUPERIORITY_OR_OTHER|||||||0.0003||95.0||||Corrected for 6 comparisons|Kruskal-Wallis|||||||0.0003
72411570|NCT01075074|144331532|SUPERIORITY_OR_OTHER||Median Difference (Net)|195.0||||0.0004|TWO_SIDED|95.0|98.0|300.0|||Wilcoxon (Mann-Whitney)|||||300|98|0.0004
72411571|NCT01075074|144331532|SUPERIORITY_OR_OTHER||Median Difference (Net)|195.0||||0.0003|TWO_SIDED|95.0|98.0|278.0|||Wilcoxon (Mann-Whitney)|||||278|98|0.0003
72411572|NCT01075074|144331532|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.0||||0.86|TWO_SIDED|95.0|-105.0|83.0|||Wilcoxon (Mann-Whitney)|||||83|-105|0.86
72579715|NCT03086551|144688681|OTHER||Effect Size - Cohen's d|-0.04|||||TWO_SIDED||||||||Cohen's d was calculated as the change from pre- to immediately post-stimulation (within the same session) for the Active arm minus the change from pre- to immediately post-stimulation for the Sham arm. The denominator reflected pooled variance.|The immediate effect of continuous theta burst stimulation over dorsolateral prefrontal cortex prior to practice was assessed by determining the magnitude of the effect of Active stimulation from pre-intervention to immediately post-intervention in Session 2 of the intervention. Cohen's d was used to derive effect size. The Sham stimulation change was used as the control.||||
72579716|NCT03086551|144688681|OTHER||Effect Size - Cohen's d|-0.69|||||TWO_SIDED||||||||Cohen's d was calculated as the change from pre- to immediately post-stimulation (within the same session) for the Active arm minus the change from pre- to immediately post-stimulation for the Sham arm. The denominator reflected pooled variance.|The immediate effect of continuous theta burst stimulation over dorsolateral prefrontal cortex prior to practice was assessed by determining the magnitude of the effect of Active stimulation from pre-intervention to immediately post-intervention in Session 3 of the intervention. Cohen's d was used to derive effect size. The Sham stimulation change was used as the control.||||
72579717|NCT03086551|144688681|OTHER||Effect Size - Cohen's d|0.28|||||TWO_SIDED||||||||Cohen's d was calculated as the change from pre- to immediately post-stimulation (within the same session) for the Active arm minus the change from pre- to immediately post-stimulation for the Sham arm. The denominator reflected pooled variance.|The immediate effect of continuous theta burst stimulation over dorsolateral prefrontal cortex prior to practice was assessed by determining the magnitude of the effect of Active stimulation from pre-intervention to immediately post-intervention in Session 4 of the intervention. Cohen's d was used to derive effect size. The Sham stimulation change was used as the control.||||
72579718|NCT03086551|144688682|OTHER||Effect Size - Cohen's d|-0.31|||||TWO_SIDED||||||||Cohen's d was calculated as the amplitude of the motor evoked potential at the post-intervention assessment minus the amplitude of the motor evoked potential at the pre-baseline assessment. The denominator reflected pooled variance.|Comparison of first dorsal interosseous motor evoked potential (MEP) amplitude elicited from the ipsilesional motor cortex pre-baseline to post-intervention for the Active arm when transcranial magnetic stimulator intensity was set to 120% of resting motor threshold. Estimate of effect size was derived using Cohen's d.||||
72579719|NCT03086551|144688682|OTHER||Effect Size - Cohen's d|-0.85|||||TWO_SIDED||||||||Cohen's d was calculated as the amplitude of the motor evoked potential at the post-intervention assessment minus the amplitude of the motor evoked potential at the pre-baseline assessment. The denominator reflected pooled variance.|Comparison of first dorsal interosseous motor evoked potential (MEP) amplitude elicited from the ipsilesional motor cortex pre-baseline to post-intervention for the Sham arm when transcranial magnetic stimulator intensity was set to 120% of resting motor threshold. Estimate of effect size was derived using Cohen's d.||||
72579720|NCT03086551|144688682|OTHER||Effect Size - Cohen's d|-0.35|||||TWO_SIDED||||||||Cohen's d was calculated as the amplitude of the motor evoked potential at the post-intervention assessment minus the amplitude of the motor evoked potential at the pre-baseline assessment. The denominator reflected pooled variance.|Comparison of the first dorsal interosseous motor evoked potential (MEP) amplitude elicited from the ipsilesional motor cortex pre-baseline to post-intervention for the Active arm when transcranial magnetic stimulator intensity was set to 150% of resting motor threshold. Estimate of effect size was derived using Cohen's d.||||
72579721|NCT03086551|144688682|OTHER||Effect Size - Cohen's d|1.13|||||TWO_SIDED||||||||Cohen's d was calculated as the amplitude of the motor evoked potential at the post-intervention assessment minus the amplitude of the motor evoked potential at the pre-baseline assessment. The denominator reflected pooled variance.|Comparison of the first dorsal interosseous motor evoked potential (MEP) amplitude elicited from the ipsilesional motor cortex pre-baseline to post-intervention for the Sham arm when transcranial magnetic stimulator intensity was set to 150% of resting motor threshold. Estimate of effect size was derived using Cohen's d.||||
72579722|NCT03086551|144688683|OTHER||Effect Size - Cohen's d|-0.15|||||TWO_SIDED||||||||Cohen's d was calculated as the change from pre- to post-intervention for the Active arm minus the change from pre- to post-intervention for the Sham arm. The denominator reflected pooled variance.|Comparison of the first dorsal interosseous motor evoked potential (MEP) amplitude elicited from the ipsilesional motor cortex pre-baseline to post-intervention across the Active and Sham arms when transcranial magnetic stimulator intensity was set to 120% of resting motor threshold. Comparison quantified as effect size using Cohen's d.||||
72579723|NCT03086551|144688683|OTHER||Effect Size - Cohen's d|-1.46|||||TWO_SIDED||||||||Cohen's d was calculated as the change from pre- to post-intervention for the Active arm minus the change from pre- to post-intervention for the Sham arm. The denominator reflected pooled variance.|Comparison of the first dorsal interosseous motor evoked potential (MEP) amplitude elicited from the ipsilesional motor cortex pre-baseline to post-intervention across the Active and Sham arms when transcranial magnetic stimulator intensity was set to 150% of resting motor threshold. Comparison quantified as effect size using Cohen's d.||||
72579724|NCT02487225|144688713|SUPERIORITY|||||||0.5796|||||||Kruskal-Wallis|||Admission (baseline)||||0.5796
72579725|NCT02487225|144688713|SUPERIORITY|||||||0.8415|||||||Kruskal-Wallis|||Day 5||||0.8415
72579726|NCT02487225|144688714|SUPERIORITY|||||||0.1109|||||||Kruskal-Wallis|||Admission (baseline)||||0.1109
72579727|NCT02487225|144688714|SUPERIORITY|||||||0.4619|||||||Kruskal-Wallis|||||||0.4619
72579728|NCT02487225|144688715|SUPERIORITY|||||||0.1236|||||||Kruskal-Wallis|||Admission (baseline)||||0.1236
72579729|NCT02487225|144688715|SUPERIORITY|||||||0.9468|||||||Kruskal-Wallis|||Day 5||||0.9468
72579730|NCT02487225|144688716|SUPERIORITY|||||||0.157|||||||Kruskal-Wallis|||Admission (baseline)||||0.157
72579731|NCT02487225|144688716|SUPERIORITY|||||||0.3173|||||||Kruskal-Wallis|||Day 5||||0.3173
72411573|NCT01075074|144331533|SUPERIORITY_OR_OTHER|||||||0.0005||95.0||||Corrected for multiple comparisons (n=6).|Kruskal-Wallis|||||||0.0005
72411574|NCT01075074|144331533|SUPERIORITY_OR_OTHER||Median Difference (Net)|38.0||||0.01|TWO_SIDED|95.0|8.0|50.0|||Wilcoxon (Mann-Whitney)|||||50|8|0.01
72411575|NCT01075074|144331533|SUPERIORITY_OR_OTHER||Median Difference (Net)|40.0||||0.003|TWO_SIDED|95.0|12.0|47.0|||Wilcoxon (Mann-Whitney)|||||47|12|0.003
72545135|NCT04081337|144619250|SUPERIORITY||LS Mean Difference|19.68||||0.5733|TWO_SIDED|95.0|-50.36|89.72|||ANCOVA|||||89.72|-50.36|0.5733
72545136|NCT04081337|144619251|SUPERIORITY||LS Mean Difference|-855.94|||<|0.0001|TWO_SIDED|95.0|-1090.87|-621.02|||ANCOVA|||||-621.02|-1090.87|<0.0001
72545137|NCT04081337|144619252|SUPERIORITY||LS Mean Difference|-3.22||||0.9481|TWO_SIDED|95.0|-102.65|96.2|||ANCOVA|||||96.20|-102.65|0.9481
72545138|NCT04081337|144619253|SUPERIORITY||LS Mean Difference|-0.034|||<|0.0001|TWO_SIDED|95.0|-0.051|-0.018|||ANCOVA|||||-0.018|-0.051|<0.0001
72411576|NCT01075074|144331533|SUPERIORITY_OR_OTHER||Median Difference (Net)|1.0||||0.95|TWO_SIDED|95.0|-18.0|20.0|||Wilcoxon (Mann-Whitney)|||||20|-18|0.95
72411577|NCT01075074|144331534|SUPERIORITY_OR_OTHER|||||||0.03||95.0||||Corrected for multiple comparisons (n=6).|Kruskal-Wallis|||||||0.03
72545139|NCT04081337|144619254|SUPERIORITY||LS Mean difference|-0.028||||0.0031|TWO_SIDED|95.0|-0.045|-0.01|||ANCOVA|||||-0.010|-0.045|0.0031
72545140|NCT04081337|144619255|SUPERIORITY||LS Mean difference|251.89||||0.0004|TWO_SIDED|95.0|119.09|384.69|||ANCOVA|||||384.69|119.09|0.0004
72545141|NCT04081337|144619256|SUPERIORITY||LS Mean difference|-6.87||||0.0005|TWO_SIDED|95.0|-10.51|-3.22|||ANCOVA|||For Adjusted protein oxidation||-3.22|-10.51|0.0005
72545142|NCT04081337|144619256|SUPERIORITY||LS Mean difference|14.48|||<|0.0001|TWO_SIDED|95.0|8.02|20.93|||ANCOVA|||For Adjusted fat oxidation||20.93|8.02|<0.0001
72545143|NCT04081337|144619256|SUPERIORITY||LS Mean difference|-26.64||||0.0001|TWO_SIDED|95.0|-39.46|-13.83|||ANCOVA|||Adjusted carbohydrate oxidation||-13.83|-39.46|0.0001
72545144|NCT04081337|144619257|SUPERIORITY||LS Mean difference|-8.47|||<|0.0001|TWO_SIDED|95.0|-11.04|-5.9|||Mixed Models Analysis|||||-5.90|-11.04|<0.0001
72545145|NCT04081337|144619258|SUPERIORITY||LS Mean difference|-4.08|||<|0.0001|TWO_SIDED|95.0|-5.12|-3.05|||Mixed Models Analysis|||||-3.05|-5.12|<0.0001
72545146|NCT04081337|144619259|SUPERIORITY||LS Mean difference|-5.08|||<|0.0001|TWO_SIDED|95.0|-6.93|-3.22|||ANCOVA|||||-3.22|-6.93|<0.0001
72545147|NCT04081337|144619260|SUPERIORITY||LS Mean Difference|-1.14||||0.0304|TWO_SIDED|95.0|-2.16|-0.11|||ANCOVA|||||-0.11|-2.16|0.0304
72545148|NCT04081337|144619261|SUPERIORITY||LS Mean difference|-1.83|||<|0.0001|TWO_SIDED|95.0|-2.6|-1.06|||ANCOVA|||For Triglyceride||-1.06|-2.60|<0.0001
72545149|NCT04081337|144619261|SUPERIORITY||LS Mean difference|-0.84|||<|0.0001|TWO_SIDED|95.0|-1.19|-0.48|||ANCOVA|||For VLDL||-0.48|-1.19|<0.0001
72545150|NCT04081337|144619261|SUPERIORITY||LS Mean difference|-0.53||||0.0436|TWO_SIDED|95.0|-1.05|-0.02|||ANCOVA|||For HDL||-0.02|-1.05|0.0436
72545151|NCT04081337|144619261|SUPERIORITY||LS Mean Difference|0.45||||0.0002|TWO_SIDED|95.0|0.23|0.66|||ANCOVA|||For Free fatty acid||0.66|0.23|0.0002
72545152|NCT04081337|144619262|SUPERIORITY||LS Mean Difference|0.03||||0.8762|TWO_SIDED|95.0|-0.34|0.4|||ANCOVA|||||0.40|-0.34|0.8762
72545153|NCT04081337|144619263|SUPERIORITY||LS Mean difference|3.49||||0.0126|TWO_SIDED|95.0|0.79|6.19|||ANCOVA|||||6.19|0.79|0.0126
72411578|NCT01075074|144331534|SUPERIORITY_OR_OTHER||Median Difference (Net)|30.0||||0.01|TWO_SIDED|95.0|0.0|60.0|||Wilcoxon (Mann-Whitney)|||||60|0|0.01
72411579|NCT01075074|144331534|SUPERIORITY_OR_OTHER||Median Difference (Net)|30.0||||0.04|TWO_SIDED|95.0|0.0|60.0|||Wilcoxon (Mann-Whitney)|||||60|0|0.04
72411580|NCT01075074|144331534|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.0||||0.92|TWO_SIDED|95.0|-30.0|30.0|||Wilcoxon (Mann-Whitney)|||||30|-30|0.92
72411581|NCT00844194|144331561|SUPERIORITY_OR_OTHER||LSmean|-1.49|||<|0.0001|TWO_SIDED|95.0|-1.89|-1.1|||ANCOVA|with last observation carried forward (LOCF)||||-1.10|-1.89|< 0.0001
72411582|NCT00844194|144331561|SUPERIORITY_OR_OTHER||LSmean|-1.67|||<|0.0001|TWO_SIDED|95.0|-2.3|-1.04|||ANCOVA|||||-1.04|-2.30|< 0.0001
72545154|NCT04081337|144619264|SUPERIORITY||LS Mean Difference|-1.26||||0.0222|TWO_SIDED|95.0|-2.34|-0.19|||ANCOVA|||||-0.19|-2.34|0.0222
72545155|NCT04081337|144619265|SUPERIORITY||LS Mean difference|-0.36|||<|0.0001|TWO_SIDED|95.0|-0.48|-0.23|||ANCOVA|||||-0.23|-0.48|<0.0001
72545156|NCT01578707|144619282|SUPERIORITY||||||<|0.0001|||||||Log Rank|||||||<0.0001
72545157|NCT01578707|144619283|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||||||<.0001
72545158|NCT01578707|144619284|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1653|||||||Log Rank|||||||0.1653
72545159|NCT03175120|144619310|SUPERIORITY||Treatment contrast|-0.92|||<|0.0001|TWO_SIDED|95.0|-1.09|-0.75|||ANCOVA|||The response and change from baseline in response after 26 weeks are analysed using an analysis of covariance (ANCOVA) model with treatment and previous anti-diabetic treatment as fixed factors and corresponding baseline value as covariate.||-0.75|-1.09|<.0001
72545160|NCT00678392|144619371|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.665|||<|0.0001|TWO_SIDED|95.0|0.544|0.812||P-value was obtained from 1-sided log rank test, stratified by eastern cooperative oncology group (ECOG) and prior treatment. One-sided log-rank test at 0.025 level of significance was used to compare PFS between the 2 treatment arms.|Log Rank|||||0.812|0.544|<0.0001
72545161|NCT00678392|144619372|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.969||||0.3744|TWO_SIDED|95.0|0.8|1.174|||Log Rank|P-value was obtained from a 1-sided log-rank test of treatment stratified by ECOG performance status and prior treatment.||||1.174|0.800|0.3744
72545162|NCT00678392|144619373|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|2.056||||0.0001|TWO_SIDED|95.0|1.408|3.003|||Cochran-Mantel-Haenszel|P-value was obtained from a 1-sided Cochran-Mantel-Haenszel test of treatment stratified by ECOG performance status and prior treatment.||||3.003|1.408|0.0001
72545163|NCT03255031|144619393|SUPERIORITY|||||||0.067||||||The threshold for statistical significance was p = 0.05|Mixed Models Analysis|||||||0.067
72545164|NCT03255031|144619394|SUPERIORITY|||||||0.004||||||The threshold for statistical significance was p = 0.05|Mixed Models Analysis|||||||0.004
72579732|NCT00625872|144688717|SUPERIORITY_OR_OTHER||Least squares (LS) mean difference|-0.43|STANDARD_ERROR_OF_MEAN|1.1||0.7232|TWO_SIDED|95.0|-3.93|3.08||The statistical test was 2-sided and performed at the 5 percent significance level.|ANCOVA|||Analysis of covariance (ANCOVA) method was used to calculate p-value with treatment, baseline value, study duration and site as covariates.||3.08|-3.93|0.7232
72579733|NCT00625872|144688718|SUPERIORITY_OR_OTHER||LS Mean difference|-1.61|STANDARD_ERROR_OF_MEAN|0.51||0.1941|TWO_SIDED|95.0|-8.04|4.82||The statistical test was 2-sided and performed at the 5 percent significance level.|ANCOVA|||ANCOVA method was used to calculate p-value with treatment, baseline value, study duration and site as covariates.||4.82|-8.04|0.1941
72579734|NCT00625872|144688720|SUPERIORITY_OR_OTHER|||||||0.0532||95.0||||The statistical test was 2-sided and performed at the 5 percent significance level.|Kruskal-Wallis|||For K-ABC Test (Sequential Processing): Kruskal-Wallis Analysis of Variance (ANOVA) model was used to calculate p-value.||||0.0532
72579735|NCT00625872|144688720|SUPERIORITY_OR_OTHER|||||||0.3383||95.0||||The statistical test was 2-sided and performed at the 5 percent significance level.|Kruskal-Wallis|||For K-ABC Test (Simultaneous Processing): Kruskal-Wallis ANOVA model was used to calculate p-value.||||0.3383
72579736|NCT00625872|144688720|SUPERIORITY_OR_OTHER|||||||0.683||95.0||||The statistical test was 2-sided and performed at the 5 percent significance level.|Kruskal-Wallis|||For K-ABC Test (Achievement): Kruskal-Wallis ANOVA model was used to calculate p-value.||||0.6830
72579737|NCT00625872|144688720|SUPERIORITY_OR_OTHER|||||||0.4935||95.0||||The statistical test was 2-sided and performed at the 5 percent significance level.|Kruskal-Wallis|||For K-ABC Test (Non-Verbal): Kruskal-Wallis ANOVA model was used to calculate p-value.||||0.4935
72579738|NCT00625872|144688720|SUPERIORITY_OR_OTHER|||||||0.3458||95.0||||The statistical test was 2-sided and performed at the 5 percent significance level.|Kruskal-Wallis|||For K-ABC Test (Mental Processing Composite): Kruskal-Wallis ANOVA model was used to calculate p-value.||||0.3458
72579739|NCT00625872|144688722|SUPERIORITY_OR_OTHER|||||||0.6256||95.0||||The statistical test was 2-sided and performed at the 5 percent significance level.|Kruskal-Wallis|||For KITAP Test (Distractibility): Kruskal-Wallis ANOVA model was used to calculate p-value.||||0.6256
72579740|NCT00625872|144688722|SUPERIORITY_OR_OTHER|||||||0.859||95.0||||The statistical test was 2-sided and performed at the 5 percent significance level.|Kruskal-Wallis|||For KITAP Test (Alertness): Kruskal-Wallis ANOVA model was used to calculate p-value.||||0.8590
72579741|NCT00625872|144688722|SUPERIORITY_OR_OTHER|||||||1||95.0||||The statistical test was 2-sided and performed at the 5 percent significance level.|Kruskal-Wallis|||For KITAP Test (Flexibility): Kruskal-Wallis ANOVA model was used to calculate p-value.||||1.0000
72579742|NCT00625872|144688722|SUPERIORITY_OR_OTHER|||||||0.1234||95.0||||The statistical test was 2-sided and performed at the 5 percent significance level.|Kruskal-Wallis|||For KITAP Test (Go/No Go): Kruskal-Wallis ANOVA model was used to calculate p-value.||||0.1234
72579743|NCT00625872|144688722|SUPERIORITY_OR_OTHER|||||||0.3291||95.0||||The statistical test was 2-sided and performed at the 5 percent significance level.|Kruskal-Wallis|||For KITAP Test (Vigilance): Kruskal-Wallis ANOVA model was used to calculate p-value.||||0.3291
72579744|NCT00625872|144688741|SUPERIORITY_OR_OTHER||LS Mean difference|0.14|STANDARD_ERROR_OF_MEAN|2.54||0.956|TWO_SIDED|95.0|-5.71|6.0||The statistical test was 2-sided and performed at the 5 percent significance level.|ANCOVA|||ANCOVA method was used to calculate p-value with treatment, baseline value, study duration and site as covariates.||6.00|-5.71|0.9560
72579745|NCT00625872|144688757|SUPERIORITY_OR_OTHER||LS Mean difference|0.55|STANDARD_ERROR_OF_MEAN|0.31||0.1107|TWO_SIDED|95.0|-0.15|1.25||The statistical test was 2-sided and performed at the 5 percent significance level.|ANCOVA|||ANCOVA method was used to calculate p-value with treatment, baseline value, study duration and site as covariates.||1.25|-0.15|0.1107
72579746|NCT00625872|144688759|SUPERIORITY_OR_OTHER||LS Mean difference|4.67|STANDARD_ERROR_OF_MEAN|1.54||0.0161|TWO_SIDED|95.0|1.13|8.21||The statistical test was 2-sided and performed at the 5 percent significance level.|ANCOVA|||ANCOVA method was used to calculate p-value with treatment, baseline value, study duration and site as covariates.||8.21|1.13|0.0161
72579747|NCT00625872|144688768|SUPERIORITY_OR_OTHER||LS Mean difference|-0.35|STANDARD_ERROR_OF_MEAN|0.25||0.187|TWO_SIDED|95.0|-0.89|0.2||The statistical test was 2-sided and performed at the 5 percent significance level.|ANCOVA|||Triceps SDS: ANCOVA method was used to calculate p-value with treatment, baseline value, study duration and site as covariates.||0.20|-0.89|0.1870
72579748|NCT00625872|144688768|SUPERIORITY_OR_OTHER||LS Mean difference|-0.15|STANDARD_ERROR_OF_MEAN|0.15||0.3494|TWO_SIDED|95.0|-0.49|0.19||The statistical test was 2-sided and performed at the 5 percent significance level.|ANCOVA|||Subscapular SDS: ANCOVA method was used to calculate p-value with treatment, baseline value, study duration and site as covariates.||0.19|-0.49|0.3494
72579749|NCT00625872|144688768|SUPERIORITY_OR_OTHER||LS Mean difference|-0.27|STANDARD_ERROR_OF_MEAN|0.12||0.0458|TWO_SIDED|95.0|-0.54|-0.01||The statistical test was 2-sided and performed at the 5 percent significance level.|ANCOVA|||Suprailiac SDS: ANCOVA method was used to calculate p-value with treatment, baseline value, study duration and site as covariates.||-0.01|-0.54|0.0458
72579750|NCT04208750|144688770|OTHER|Difference between independent proportions||||||||||||||||Added the number of participants from each study arm who preferred each refraction type and then converted it to the proportions|For each outcome, we compared the proportion of participants from both study arms who preferred the VR800 refraction to the proportion of participants who preferred the Standard refraction using a 2-sample test for equality of proportions.|||
72579751|NCT02201277|144688771|SUPERIORITY|||||||1|||||||t-test, 2 sided|||A Fisher's exact test was used to determine if there was a difference in the numbers of filters with penetration for each type. The numbers were not powered enough to make extensive tests in this area meaningful.||||1.0
72579752|NCT02201277|144688771|EQUIVALENCE|rate of penetration||||||1|||||||t-test, 1 sided|||||||1.0
72579753|NCT01512160|144688797|SUPERIORITY_OR_OTHER||Least squares (LS) mean difference|-1.1|STANDARD_ERROR_OF_MEAN|1.9|||TWO_SIDED|90.0|-4.3|2.2||||||Analysis of co-variance (ANCOVA) model was used with treatment as a fixed effect and baseline pain intensity as a covariate. LS mean estimates of the treatment difference along with 90 percent (%) confidence interval (CI) was presented.||2.2|-4.3|
72579754|NCT01512160|144688797|SUPERIORITY_OR_OTHER||LS mean difference|-0.9|STANDARD_ERROR_OF_MEAN|1.9|||TWO_SIDED|90.0|-4.1|2.3||||||ANCOVA model was used with treatment as a fixed effect and baseline pain intensity as a covariate. LS mean estimates of the treatment difference along with 90% CI was presented.||2.3|-4.1|
72411583|NCT00406029|144331701|SUPERIORITY_OR_OTHER||Difference in LS Means|0.2||||0.753|TWO_SIDED|95.0|-0.9|1.2||The alpha threshold for statistical significance is 0.049 (2-sided).|ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.2|-0.9|0.753
72545165|NCT03151499|144619403|OTHER||Geometric mean (gMean) ratio (%)|7.8|STANDARD_ERROR_OF_MEAN|1.19|||TWO_SIDED|90.0|5.74|10.601|||||gMean ratio = BI 409306 + Rifampicin pretreatment (T) / BI 409306 (R). Standard Error of the mean is actually the Geometric Standard Error.|The main focus is on estimation, therefore no hypothesis was tested. The statistical analysis model for the primary endpoints is an ANOVA (analysis of variance). This model included effects accounting for the following sources of variation: 'subjects' and 'treatment'. The effect 'subjects' will be considered as random, whereas the treatment effect will be considered as fixed. The PK endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model.||10.601|5.740|
72411584|NCT00406029|144331701|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.7||||0.162|TWO_SIDED|95.0|-1.7|0.3||The alpha threshold for statistical significance is 0.049 (2-sided).|ANCOVA|||LS means treatment difference in change from baseline at endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.3|-1.7|0.162
72411585|NCT00406029|144331701|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.0||||0.049|TWO_SIDED|95.0|-2.1|0.0||The alpha threshold for statistical significance is 0.049 (2-sided).|ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.0|-2.1|0.049
72579755|NCT01512160|144688797|SUPERIORITY_OR_OTHER||LS mean difference|3.5|STANDARD_ERROR_OF_MEAN|1.9|||TWO_SIDED|90.0|0.3|6.7||||||ANCOVA model was used with treatment as a fixed effect and baseline pain intensity as a covariate. LS mean estimates of the treatment difference along with 90% CI was presented.||6.7|0.3|
72579756|NCT01512160|144688801|SUPERIORITY_OR_OTHER||LS mean difference|-0.4|STANDARD_ERROR_OF_MEAN|1.4|||TWO_SIDED|90.0|-2.8|1.9||||||SPID 0-6: LS mean estimates of the treatment difference along with 90% CI were based on ANCOVA model including treatment as a fixed effect and baseline pain intensity as a covariate.||1.9|-2.8|
72579757|NCT01512160|144688801|SUPERIORITY_OR_OTHER||LS mean difference|-0.3|STANDARD_ERROR_OF_MEAN|1.4|||TWO_SIDED|90.0|-2.7|2.0||||||SPID 0-6: LS mean estimates of the treatment difference along with 90% CI were based on ANCOVA model including treatment as a fixed effect and baseline pain intensity as a covariate.||2.0|-2.7|
72579758|NCT01512160|144688801|SUPERIORITY_OR_OTHER||LS mean difference|2.8|STANDARD_ERROR_OF_MEAN|1.4|||TWO_SIDED|90.0|0.4|5.1||||||SPID 0-6: LS mean estimates of the treatment difference along with 90% CI were based on ANCOVA model including treatment as a fixed effect and baseline pain intensity as a covariate.||5.1|0.4|
72579759|NCT01512160|144688801|SUPERIORITY_OR_OTHER||LS mean difference|-1.0|STANDARD_ERROR_OF_MEAN|7.0|||TWO_SIDED|90.0|-12.6|10.5||||||SPID 0-24: LS mean estimates of the treatment difference along with 90% CI were based on ANCOVA model including treatment as a fixed effect and baseline pain intensity as a covariate.||10.5|-12.6|
72579760|NCT01512160|144688801|SUPERIORITY_OR_OTHER||LS mean difference|-0.1|STANDARD_ERROR_OF_MEAN|6.9|||TWO_SIDED|90.0|-11.5|11.4||||||SPID 0-24: LS mean estimates of the treatment difference along with 90% CI were based on ANCOVA model including treatment as a fixed effect and baseline pain intensity as a covariate.||11.4|-11.5|
72579761|NCT01512160|144688801|SUPERIORITY_OR_OTHER||LS mean difference|7.6|STANDARD_ERROR_OF_MEAN|7.0|||TWO_SIDED|90.0|-4.0|19.1||||||SPID 0-24: LS mean estimates of the treatment difference along with 90% CI were based on ANCOVA model including treatment as a fixed effect and baseline pain intensity as a covariate.||19.1|-4.0|
72579762|NCT01512160|144688802|SUPERIORITY_OR_OTHER||LS mean difference|0.2|STANDARD_ERROR_OF_MEAN|9.5|||TWO_SIDED|90.0|-15.6|16.1||||||LS mean estimates of the treatment difference along with 90% CI were based on ANCOVA model including treatment as a fixed effect and baseline pain intensity as a covariate.||16.1|-15.6|
72579763|NCT01512160|144688802|SUPERIORITY_OR_OTHER||LS mean difference|-0.8|STANDARD_ERROR_OF_MEAN|9.4|||TWO_SIDED|90.0|-16.5|14.8||||||LS mean estimates of the treatment difference along with 90% CI were based on ANCOVA model including treatment as a fixed effect and baseline pain intensity as a covariate.||14.8|-16.5|
72579764|NCT01512160|144688802|SUPERIORITY_OR_OTHER||LS mean difference|9.3|STANDARD_ERROR_OF_MEAN|9.5|||TWO_SIDED|90.0|-6.6|25.1||||||LS mean estimates of the treatment difference along with 90% CI were based on ANCOVA model including treatment as a fixed effect and baseline pain intensity as a covariate.||25.1|-6.6|
72579765|NCT01512160|144688803|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.8|||||TWO_SIDED|90.0|0.5|1.5||||||Hazard Ratio (HR) estimates of the treatment difference along with 90% CI were based Cox proportional hazards model including treatment and baseline pain intensity as fixed effects.||1.5|0.5|
72411586|NCT00406029|144331701|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.2||||0.019|TWO_SIDED|95.0|-2.2|-0.2||The alpha threshold for statistical significance is 0.049 (2-sided).|ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.||-0.2|-2.2|0.019
72411587|NCT00406029|144331702|SUPERIORITY_OR_OTHER||Difference in LS Means|0.0||||0.935|TWO_SIDED|95.0|-0.9|0.8|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.8|-0.9|0.935
72411588|NCT00406029|144331702|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.4||||0.326|TWO_SIDED|95.0|-1.3|0.4|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.4|-1.3|0.326
72579766|NCT01512160|144688803|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.2|||||TWO_SIDED|90.0|0.7|2.1||||||HR estimates of the treatment difference along with 90% CI were based Cox proportional hazards model including treatment and baseline pain intensity as fixed effects.||2.1|0.7|
72579767|NCT01512160|144688803|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.1|||||TWO_SIDED|90.0|0.6|2.0||||||HR estimates of the treatment difference along with 90% CI were based Cox proportional hazards model including treatment and baseline pain intensity as fixed effects.||2.0|0.6|
72579768|NCT01512160|144688804|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.0|||||TWO_SIDED|90.0|0.5|2.1||||||HR estimates of the treatment difference along with 90% CI were based Cox proportional hazards model including treatment and baseline pain intensity as fixed effects.||2.1|0.5|
72579769|NCT01512160|144688804|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.9|||||TWO_SIDED|90.0|0.4|1.8||||||HR estimates of the treatment difference along with 90% CI were based Cox proportional hazards model including treatment and baseline pain intensity as fixed effects.||1.8|0.4|
72579770|NCT01512160|144688804|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.5|||||TWO_SIDED|90.0|0.7|2.9||||||HR estimates of the treatment difference along with 90% CI were based Cox proportional hazards model including treatment and baseline pain intensity as fixed effects.||2.9|0.7|
72579771|NCT01512160|144688805|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.0|||||TWO_SIDED|90.0|0.6|1.9||||||HR estimates of the treatment difference along with 90% CI were based Cox proportional hazards model including treatment and baseline pain intensity as fixed effects.||1.9|0.6|
72545166|NCT03151499|144619404|OTHER||Geometric mean (gMean) ratio (%)|9.77|STANDARD_ERROR_OF_MEAN|1.232|||TWO_SIDED|90.0|6.767|14.098|||||gMean ratio = BI 409306 + Rifampicin pretreatment (T) / BI 409306 (R). Standard Error of the mean is actually the Geometric Standard Error.|The main focus is on estimation, therefore no hypothesis was tested. The statistical analysis model for the primary endpoints is an ANOVA (analysis of variance). This model included effects accounting for the following sources of variation: 'subjects' and 'treatment'. The effect 'subjects' will be considered as random, whereas the treatment effect will be considered as fixed. The PK endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model.||14.098|6.767|
72545167|NCT03151499|144619405|OTHER||Geometric mean (gMean) ratio (%)|8.23|STANDARD_ERROR_OF_MEAN|1.187|||TWO_SIDED|90.0|6.081|11.126|||||gMean ratio = BI 409306 + Rifampicin pretreatment (T) / BI 409306 (R). Standard Error of the mean is actually the Geometric Standard Error.|Since the main focus is on estimation and not testing, therefore no hypothesis was tested.The statistical analysis model is an ANOVA (analysis of variance) model on the logarithmic scale. This model included effects accounting for the following sources of variation: 'subjects' and 'treatment'. The effect 'subjects' will be considered as random, whereas the treatment effect will be considered as fixed. The PK endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model.||11.126|6.081|
72545168|NCT03563027|144619407|SUPERIORITY||Mean Difference (Net)|433.0||||0.81|TWO_SIDED|95.0|-337.0|1203.0|||Regression, Linear|||||1203|-337|.81
72545169|NCT03563027|144619407|SUPERIORITY||Mean Difference (Net)|1224.0||||0.005|TWO_SIDED|95.0|451.0|1996.0|||Regression, Linear|||||1996|451|.005
72545170|NCT03563027|144619408|SUPERIORITY||Mean Difference (Net)|-160.0||||0.92|TWO_SIDED|95.0|-983.0|663.0|||Regression, Linear|||||663|-983|.92
72545171|NCT03563027|144619408|SUPERIORITY||Mean Difference (Net)|564.0||||0.37|TWO_SIDED|95.0|-261.0|1389.0|||Regression, Linear|||||1389|-261|.37
72545172|NCT03563027|144619409|SUPERIORITY||Median Difference (Net)|0.21|||<|0.001|TWO_SIDED|95.0|0.18|0.24|||Regression, Linear|||||.24|.18|<.001
72545173|NCT03563027|144619409|SUPERIORITY||Mean Difference (Net)|0.34|||<|0.001|TWO_SIDED|95.0|0.31|0.37|||Regression, Linear|||||.37|.31|<.001
72545174|NCT03563027|144619410|SUPERIORITY||Mean Difference (Net)|0.09|||<|0.001|TWO_SIDED|95.0|0.06|0.1|||Regression, Linear|||||0.1|.06|<.001
72545175|NCT03563027|144619410|SUPERIORITY||Median Difference (Net)|0.18|||<|0.001|TWO_SIDED|95.0|0.15|0.2|||Regression, Linear|||||.20|.15|<.001
72545176|NCT00415532|144619411|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.172|||<|0.0001||95.0|0.084|0.352||Significant level is set at 0.05|Cochran-Mantel-Haenszel|||||0.352|0.084|<0.0001
72545177|NCT00415532|144619412|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.307||||0.0005||95.0|0.154|0.611||Significant level is set at 0.05|Cochran-Mantel-Haenszel|||||0.611|0.154|0.0005
72545178|NCT00415532|144619415|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0133||||||Significant level is set at 0.05|Mixed Models Analysis|||||||0.0133
72545179|NCT00415532|144619416|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3434||||||Significant level is set at 0.05|Mixed Models Analysis|||||||0.3434
72545180|NCT00415532|144619417|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0076||||||Significant level is set at 0.05|Mixed Models Analysis|||||||0.0076
72545181|NCT00415532|144619418|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0246||||||Significant level is set at 0.05|Mixed Models Analysis|||||||0.0246
72579772|NCT01512160|144688805|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.3|||||TWO_SIDED|90.0|0.7|2.4||||||HR estimates of the treatment difference along with 90% CI were based Cox proportional hazards model including treatment and baseline pain intensity as fixed effects.||2.4|0.7|
72579773|NCT01512160|144688805|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.7|||||TWO_SIDED|90.0|0.4|1.3||||||HR estimates of the treatment difference along with 90% CI were based Cox proportional hazards model including treatment and baseline pain intensity as fixed effects.||1.3|0.4|
72545182|NCT01952574|144619428|SUPERIORITY|To maintain the type I error at ≤ 0.05, the pairwise comparison was tested in a sequential testing procedure in the order of erenumab 70 mg vs placebo, 21 mg vs placebo, and 7 mg vs placebo. The lower dose group was only to be tested when the higher dose group was tested as significant.|LS Mean Difference|-1.12||||0.021|TWO_SIDED|95.0|-2.06|-0.17|||Generalized Linear Mixed Model|||The primary analysis utilized a generalized linear mixed model which included treatment, visit, treatment by visit, the stratification factor region, and baseline value as covariates.||-0.17|-2.06|0.021
72545183|NCT01952574|144619428|SUPERIORITY|To maintain the type I error at ≤ 0.05, the pairwise comparison was tested in a sequential testing procedure in the order of erenumab 70 mg vs placebo, 21 mg vs placebo, and 7 mg vs placebo. The lower dose group was only to be tested when the higher dose group was tested as significant.|LS Mean Difference|-0.1||||0.83|TWO_SIDED|95.0|-1.07|0.86|||Generalized Linear Mixed Model|||The primary analysis utilized a generalized linear mixed model which included treatment, visit, treatment by visit, the stratification factor region, and baseline value as covariates.||0.86|-1.07|0.83
72545184|NCT01952574|144619428|SUPERIORITY|To maintain the type I error at ≤ 0.05, the pairwise comparison was tested in a sequential testing procedure in the order of erenumab 70 mg vs placebo, 21 mg vs placebo, and 7 mg vs placebo. The lower dose group was only to be tested when the higher dose group was tested as significant.|LS Mean Difference|0.11||||0.82|TWO_SIDED|92.0|-0.83|1.05|||Generalized Linear Mixed Model|||The primary analysis utilized a generalized linear mixed model which included treatment, visit, treatment by visit, the stratification factor region, and baseline value as covariates.||1.05|-0.83|0.82
72579774|NCT00852202|144688823|SUPERIORITY|||||||0.7408|||||||ANCOVA|||||||0.7408
72579775|NCT00852202|144688823|SUPERIORITY|||||||0.9961|||||||ANCOVA|||||||0.9961
72579776|NCT00852202|144688824|SUPERIORITY|||||||0.3441|||||||ANCOVA|||||||0.3441
72579777|NCT00852202|144688824|SUPERIORITY|||||||0.2683|||||||ANCOVA|||||||0.2683
72411589|NCT00406029|144331702|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.8||||0.07|TWO_SIDED|95.0|-1.7|0.1|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.1|-1.7|0.070
72411590|NCT00406029|144331702|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.0||||0.02|TWO_SIDED|95.0|-1.9|-0.2|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.||-0.2|-1.9|0.020
72411591|NCT00406029|144331702|SUPERIORITY_OR_OTHER||Difference in LS Means|0.0||||0.982|TWO_SIDED|95.0|-1.0|1.0|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.0|-1.0|0.982
72545185|NCT01952574|144619429|SUPERIORITY||Odds Ratio (OR)|2.0||||0.011|TWO_SIDED|95.0|1.17|3.42|||Generalised Linear Mixed Model|Generalized linear mixed model including treatment, visit, treatment by visit, stratification factor region, and baseline value as covariates.||The generalized linear mixed model includes data for all participants in the efficacy analysis set with at least one percent change from baseline value in monthly migraine days (152 participants in the placebo group and 104 in the erenumab 70 mg group)||3.42|1.17|0.011
72545186|NCT01952574|144619429|SUPERIORITY||Odds Ratio (OR)|1.25||||0.44|TWO_SIDED|95.0|0.71|2.18|||Generalized Linear Mixed Model|Generalized linear mixed model including treatment, visit, treatment by visit, stratification factor region, and baseline value as covariates.||The generalized linear mixed model includes data for all participants in the efficacy analysis set with at least one change from baseline value in monthly migraine days (152 participants in the placebo group and 99 in the erenumab 21 mg group)||2.18|0.71|0.44
72545187|NCT01952574|144619429|SUPERIORITY||Odds Ratio (OR)|0.93||||0.8|TWO_SIDED|95.0|0.53|1.63|||Generalized Linear Mixed Model|Generalized linear mixed model including treatment, visit, treatment by visit, stratification factor region, and baseline value as covariates.||The generalized linear mixed model includes data for all participants in the efficacy analysis set with at least one change from baseline value in monthly migraine days (152 participants in the placebo group and 107 in the erenumab 7 mg group)||1.63|0.53|0.80
72545188|NCT01952574|144619430|SUPERIORITY||LS Mean Difference|-0.4||||0.13|TWO_SIDED|95.0|-0.92|0.12|||Generalized Linear Mixed Model|Generalized linear mixed model including treatment, visit, treatment by visit, the stratification factor region, and baseline value as covariates.||||0.12|-0.92|0.13
72545189|NCT01952574|144619430|SUPERIORITY||LS Mean Difference|0.02||||0.95|TWO_SIDED|95.0|-0.51|0.54|||Generalized Linear Mixed Model|Generalized linear mixed model including treatment, visit, treatment by visit, the stratification factor region, and baseline value as covariates.||||0.54|-0.51|0.95
72545190|NCT01952574|144619430|SUPERIORITY||LS Mean Difference|0.37||||0.16|TWO_SIDED|95.0|-0.14|0.87|||Generalized Linear Mixed Model|Generalized linear mixed model including treatment, visit, treatment by visit, the stratification factor region, and baseline value as covariates.||||0.87|-0.14|0.16
72545191|NCT00770991|144619446|SUPERIORITY_OR_OTHER|||||||0.065|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||All patients received BRB suppositories and were pooled for the analysis comparing baseline and end of study polyp counts.||||0.065
72545192|NCT00770991|144619447|SUPERIORITY_OR_OTHER|||||||0.016|TWO_SIDED|95.0|||||Chi-squared|||||||0.016
72545193|NCT00770991|144619448|SUPERIORITY_OR_OTHER|||||||0.043|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.043
72411592|NCT00406029|144331702|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.5||||0.281|TWO_SIDED|95.0|-1.5|0.4|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.4|-1.5|0.281
72411593|NCT00406029|144331702|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.6||||0.261|TWO_SIDED|95.0|-1.6|0.4|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.4|-1.6|0.261
72411594|NCT00406029|144331702|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.4||||0.447|TWO_SIDED|95.0|-1.4|0.6|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.6|-1.4|0.447
72411595|NCT00406029|144331702|SUPERIORITY_OR_OTHER||Difference in LS Means|0.5||||0.378|TWO_SIDED|95.0|-0.6|1.6|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.6|-0.6|0.378
72545194|NCT02040766|144619459|SUPERIORITY||Mean Difference (Final Values)|2.81||||0.0063|TWO_SIDED|95.0|0.796|4.821||significance at 0.05.|ANCOVA|||ANCOVA model with effects due to baseline trough morning percent predicted FEV1, sex, age, current protocol-allowed asthma therapy (inhaled corticosteroid (ICS) or non-corticosteroid (NCS) therapy) at the time of screening visit, during the run-in period, and during treatment.||4.821|0.796|0.0063
72545195|NCT02040766|144619459|SUPERIORITY||Mean Difference (Final Values)|0.63||||0.5332|TWO_SIDED|95.0|-1.354|2.614||significance at 0.05.|ANCOVA|||ANCOVA model with effects due to baseline trough morning percent predicted FEV1, sex, age, current protocol-allowed asthma therapy (ICS or NCS therapy) at the time of screening visit, during the run-in period, and during treatment.||2.614|-1.354|0.5332
72545196|NCT02040766|144619459|SUPERIORITY||Mean Difference (Final Values)|0.92||||0.3649|TWO_SIDED|95.0|-1.077|2.924||significance at 0.05|ANCOVA|||ANCOVA model with effects due to baseline trough morning percent predicted FEV1, sex, age, current protocol-allowed asthma therapy (ICS or NCS therapy) at the time of screening visit, during the run-in period, and during treatment.||2.924|-1.077|0.3649
72545197|NCT02040766|144619459|SUPERIORITY||Mean Difference (Final Values)|1.09||||0.2823|TWO_SIDED|95.0|-0.902|3.088|||ANCOVA|||||3.088|-0.902|0.2823
72411596|NCT00406029|144331702|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.6||||0.299|TWO_SIDED|95.0|-1.7|0.5|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.5|-1.7|0.299
72411597|NCT00406029|144331702|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.5||||0.377|TWO_SIDED|95.0|-1.6|0.6|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.6|-1.6|0.377
72411598|NCT00406029|144331702|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.2||||0.707|TWO_SIDED|95.0|-1.3|0.9|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.9|-1.3|0.707
72579778|NCT02972892|144688825|NON_INFERIORITY|Using t-test, comparison of the weighted average percent duration between the Et Control and control device was performed by calculating the difference and its 95% 2-sided confidence interval between the two arms. Non-inferiority will be concluded if the lower limit of the 95% confidence interval is ≥ -5% for both EtAA.|Mean Difference (Net)|10.9|||<|0.001|TWO_SIDED|95.0|6.89|15.01|||t-test, 2 sided|||Using t-test, comparison of the weighted average percent duration between the Et Control and control device was performed by calculating the difference and its 95% 2-sided confidence interval between the two arms. Non-inferiority will be concluded if the lower limit of the 95% confidence interval is ≥ -5% for both EtAA.||15.01|6.89|<.001
72579779|NCT02972892|144688826|NON_INFERIORITY|Using t-test, comparison of the weighted average percent duration between the Et Control and control device was performed by calculating the difference and its 95% 2-sided confidence interval between the two arms. Non-inferiority will be concluded if the lower limit of the 95% confidence interval is ≥ -5% for both EtAA.|Mean Difference (Net)|52.1|||<|0.001|TWO_SIDED|95.0|46.25|57.95|||t-test, 2 sided|||Using t-test, comparison of the weighted average percent duration between the Et Control and control device was performed by calculating the difference and its 95% 2-sided confidence interval between the two arms. Non-inferiority will be concluded if the lower limit of the 95% confidence interval is ≥ -5% for both EtAA.||57.95|46.25|<.001
72579780|NCT02972892|144688827|NON_INFERIORITY|Using t-test, comparison of the weighted average percent duration between the Et Control and control device will be performed by calculating the difference and its 95% 2-sided confidence interval between the two arms. Non-inferiority will be concluded if the lower limit of the 95% confidence interval is ≥ -5% for EtO2.|Mean Difference (Net)|5.3|||<|0.001|TWO_SIDED|95.0|2.64|8.04|||t-test, 2 sided|||Using t-test, comparison of the weighted average percent duration between the Et Control and control device will be performed by calculating the difference and its 95% 2-sided confidence interval between the two arms. Non-inferiority will be concluded if the lower limit of the 95% confidence interval is ≥ -5% for EtO2.||8.04|2.64|<.001
72579781|NCT02972892|144688828|NON_INFERIORITY|Using t-test, comparison of the weighted average percent duration between the Et Control and control device will be performed by calculating the difference and its 95% 2-sided confidence interval between the two arms. Non-inferiority will be concluded if the lower limit of the 95% confidence interval is ≥ -5% for EtO2.|Mean Difference (Net)|44.5|||<|0.001|TWO_SIDED|95.0|35.56|53.41|||t-test, 2 sided|||Using t-test, comparison of the weighted average percent duration between the Et Control and control device will be performed by calculating the difference and its 95% 2-sided confidence interval between the two arms. Non-inferiority will be concluded if the lower limit of the 95% confidence interval is ≥ -5% for EtO2.||53.41|35.56|<.001
72579782|NCT02694328|144688854|SUPERIORITY||Least Squares Mean Difference|-2.38|STANDARD_ERROR_OF_MEAN|0.765||0.003|TWO_SIDED|95.0|-3.88|-0.88||P-value was adjusted using the Cui, Hung, and Wang (CHW) method to account for the unblinded interim analysis for sample size re-estimation.|ANCOVA|Missing values at Week 24 were imputed using multiple imputation.||||-0.88|-3.88|0.003
72579783|NCT02694328|144688855|SUPERIORITY||Risk Difference (RD)|-13.7||||0.003|TWO_SIDED|95.0|-22.8|-4.6||P-value was adjusted using the CHW method to account for the unblinded interim analysis for sample size re-estimation.|Regression, Logistic|Missing values at Week 24 were imputed using multiple imputation.|Risk difference (RD) of ALKS 3831 vs. Olanzapine|||-4.6|-22.8|0.003
72579784|NCT02694328|144688856|SUPERIORITY||Risk Difference (RD)|-15.9||||0.001|TWO_SIDED|95.0|-25.3|-6.5|||Regression, Logistic|Missing values at Week 24 were imputed using multiple imputation.|Risk difference (RD) ALKS 3831 vs. Olanzapine|||-6.5|-25.3|0.001
72579785|NCT04205812|144688864|SUPERIORITY||Hazard Ratio (HR)|0.75||||0.0042|TWO_SIDED|95.0|0.6|0.93||The p-value was based on a stratified log-rank test at an overall 1-sided 2.5% level of significance, using O'Brien and Fleming boundary to adjust for alpha spending at interim analysis.|Log Rank||A stratified Cox regression with Efron's method for tie handling was used to estimate the hazard ratio.|||0.93|0.60|0.0042
72579786|NCT04205812|144688865|SUPERIORITY||Hazard Ratio (HR)|0.64|||<|0.0001|TWO_SIDED|95.0|0.52|0.79|||Log Rank|The p-value was based on the stratified log-rank test for PFS.|A stratified Cox regression with Efron's method for tie handling was used to estimate the hazard ratio.|||0.79|0.52|<0.0001
72411599|NCT00406029|144331702|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.3||||0.562|TWO_SIDED|95.0|-1.4|0.7|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.7|-1.4|0.562
72411600|NCT00406029|144331702|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.7||||0.156|TWO_SIDED|95.0|-1.7|0.3|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.3|-1.7|0.156
72411601|NCT00406029|144331702|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.5||||0.292|TWO_SIDED|95.0|-1.6|0.5|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.5|-1.6|0.292
72411602|NCT00406029|144331702|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.2||||0.034|TWO_SIDED|95.0|-2.2|-0.1|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.||-0.1|-2.2|0.034
72411603|NCT00406029|144331702|SUPERIORITY_OR_OTHER||Difference in LS Means|0.2||||0.762|TWO_SIDED|95.0|-0.9|1.2|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.2|-0.9|0.762
72411604|NCT00406029|144331702|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.9||||0.092|TWO_SIDED|95.0|-1.9|0.1|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.1|-1.9|0.092
72411605|NCT00406029|144331702|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.3||||0.013|TWO_SIDED|95.0|-2.3|-0.3|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.||-0.3|-2.3|0.013
72411606|NCT00406029|144331702|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.5||||0.005|TWO_SIDED|95.0|-2.5|-0.4|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.||-0.4|-2.5|0.005
72545198|NCT02040766|144619460|SUPERIORITY||Mean Difference (Final Values)|11.3||||0.0001|TWO_SIDED|95.0|5.58|17.06|||Mixed Models Analysis|||||17.06|5.58|0.0001
72411607|NCT00406029|144331702|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.6||||0.293|TWO_SIDED|95.0|-1.8|0.6|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.6|-1.8|0.293
72411608|NCT00406029|144331702|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.9||||0.095|TWO_SIDED|95.0|-2.0|0.2|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.2|-2.0|0.095
72545199|NCT02040766|144619460|SUPERIORITY||Mean Difference (Final Values)|8.5||||0.0041|TWO_SIDED|95.0|2.71|14.24|||Mixed Models Analysis|||||14.24|2.71|0.0041
72545200|NCT02040766|144619460|SUPERIORITY||Mean Difference (Final Values)|7.6||||0.0103|TWO_SIDED|95.0|1.79|13.35|||Mixed Models Analysis|||||13.35|1.79|0.0103
72545201|NCT02040766|144619460|SUPERIORITY||Mean Difference (Final Values)|6.5||||0.0278|TWO_SIDED|95.0|0.71|12.23|||Mixed Models Analysis|||||12.23|0.71|0.0278
72545202|NCT02040766|144619461|SUPERIORITY||Mean Difference (Final Values)|11.7|||<|0.0001|TWO_SIDED|95.0|5.96|17.45|||Mixed Models Analysis|||||17.45|5.96|<0.0001
72545203|NCT02040766|144619461|SUPERIORITY||Mean Difference (Final Values)|10.0||||0.0007|TWO_SIDED|95.0|4.2|15.76|||Mixed Models Analysis|||||15.76|4.20|0.0007
72545204|NCT02040766|144619461|SUPERIORITY||Mean Difference (Final Values)|9.9||||0.0008|TWO_SIDED|95.0|4.11|15.68|||Mixed Models Analysis|||||15.68|4.11|0.0008
72545205|NCT02040766|144619461|SUPERIORITY||Mean Difference (Final Values)|8.7||||0.0031|TWO_SIDED|95.0|2.95|14.49|||Mixed Models Analysis|||||14.49|2.95|0.0031
72545206|NCT02040766|144619462|SUPERIORITY||Mean Difference (Final Values)|-0.36||||0.0002|TWO_SIDED|95.0|-0.548|-0.174|||Mixed Models Analysis|||||-0.174|-0.548|0.0002
72545207|NCT02040766|144619462|SUPERIORITY||Mean Difference (Final Values)|-0.14||||0.132|TWO_SIDED|95.0|-0.331|0.044|||Mixed Models Analysis|||||0.044|-0.331|0.1320
72545208|NCT02040766|144619462|SUPERIORITY||Mean Difference (Final Values)|-0.05||||0.5866|TWO_SIDED|95.0|-0.24|0.136|||Mixed Models Analysis|||||0.136|-0.240|0.5866
72545209|NCT02040766|144619462|SUPERIORITY||Mean Difference (Final Values)|-0.18||||0.0587|TWO_SIDED|95.0|-0.369|0.007|||Mixed Models Analysis|||||0.007|-0.369|0.0587
72545210|NCT02040766|144619463|SUPERIORITY||Mean Difference (Final Values)|-0.16||||0.0011|TWO_SIDED|95.0|-0.261|-0.065|||Mixed Models Analysis|||||-0.065|-0.261|0.0011
72545211|NCT02040766|144619463|SUPERIORITY||Mean Difference (Final Values)|-0.09||||0.0869|TWO_SIDED|95.0|-0.185|0.013|||Mixed Models Analysis|||||0.013|-0.185|0.0869
72545212|NCT02040766|144619463|SUPERIORITY||Mean Difference (Final Values)|-0.04||||0.4388|TWO_SIDED|95.0|-0.138|0.06|||Mixed Models Analysis|||||0.060|-0.138|0.4388
72545213|NCT02040766|144619463|SUPERIORITY||Mean Difference (Final Values)|-0.08||||0.1041|TWO_SIDED|95.0|-0.18|0.017|||Mixed Models Analysis|||||0.017|-0.180|0.1041
72545214|NCT02040766|144619464|SUPERIORITY|||||||0.287|||||||Log Rank|||||||0.2870
72545215|NCT02040766|144619464|SUPERIORITY|||||||0.5257|||||||Log Rank|||||||0.5257
72411609|NCT00406029|144331702|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.2||||0.04||95.0|-2.3|-0.1|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.||-0.1|-2.3|0.040
72411610|NCT00406029|144331702|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.4||||0.011|TWO_SIDED|95.0|-2.5|-0.3|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.||-0.3|-2.5|0.011
72545216|NCT02040766|144619464|SUPERIORITY|||||||0.9982|||||||Log Rank|||||||0.9982
72545217|NCT02040766|144619464|SUPERIORITY|||||||0.7633|||||||Log Rank|||||||0.7633
72579787|NCT04205812|144688866|SUPERIORITY|||||||0.0012||||||The p-value was calculated at the 1-sided 2.5% level from stratified Cochran-Mantel-Haenszel test.|Cochran-Mantel-Haenszel|||||||0.0012
72411611|NCT00406029|144331703|SUPERIORITY_OR_OTHER||Difference in LS Means|0.3||||0.47|TWO_SIDED|95.0|-0.6|1.2|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.2|-0.6|0.470
72579788|NCT06473519|144688881|NON_INFERIORITY|Noninferiority of immune responses induced by MDVRSV preF compared to SDVRSV preF, assessed for RSVA\&B at 1month after vaccination. Null hypotheses(H0): RSVA(H0A)=ln(μMDV)-ln(μSDV)\<=-ln(1.5);RSVB(H0B):ln(μMDV)-ln(μSDV)\<=-ln(1.5), where ln(μMDV)\&ln(μSDV) are means of natural log-transformed antibody concentrations 1month after vaccination for MDV and SDV groups, respectively. Noninferiority=if lower bounds of 2-sided95%CI for GMT ratios (MDV/SDV) were \>0.67(noninferiority margin=1.5)for RSVA\&B.|Geometric mean ratio|0.96|||||TWO_SIDED|95.0|0.84|1.1|||||GMR was calculated as group mean difference of logarithmically transformed antibody levels, back transformed to original units.|RSV A||1.10|0.84|
72579789|NCT06473519|144688881|NON_INFERIORITY|Noninferiority of immune responses induced by MDVRSV preF compared to SDVRSV preF, assessed for RSVA\&B at 1 month after vaccination. Null hypotheses(H0):RSVA(H0A)=ln(μMDV)-ln(μSDV)\<=-ln(1.5);RSVB(H0B):ln(μMDV)-ln(μSDV)\<=-ln(1.5), where ln(μMDV)\&ln(μSDV) are means of natural log-transformed antibody concentrations 1 month after vaccination for MDV and SDV groups, respectively. Noninferiority=if lower bounds of 2-sided 95%CI for GMT ratios(MDV/SDV) were \>0.67(noninferiority margin=1.5)for RSVA\&B.|Geometric mean ratio|0.91|||||TWO_SIDED|95.0|0.79|1.06|||||GMR was calculated as group mean difference of logarithmically transformed antibody levels, back transformed to original units.|RSV B||1.06|0.79|
72579790|NCT02514447|144688894|SUPERIORITY||||||<|0.0001||||||A Hochberg-based gatekeeping procedure was used to control the global familywise error rate across the multiple null hypotheses (primary and key secondary myelosuppression efficacy endpoints) in a strong sense at a 1-sided 0.10 level.|non-parametric ANCOVA|Hochberg-based gatekeeping procedure||Analysis was for Part 2 data: Treatment difference was evaluated using a nonparametric analysis of covariance (ANCOVA). The nonparametric ANCOVA included study baseline ANC value as covariate, stratification factors of ECOG performance status (0 to 1 versus 2) and sensitivity to first line treatment (sensitive or resistant) and treatment as fixed effects.||||<0.0001
72579791|NCT02514447|144688895|SUPERIORITY|||||||0.016||||||A Hochberg-based gatekeeping procedure was used to control the global familywise error rate across the multiple null hypotheses (primary and key secondary myelosuppression efficacy endpoints) in a strong sense at a 1-sided 0.10 level.|Modified Poisson|Hochberg-based gatekeeping procedure||The occurrence of SN was a binary variable. Treatment group difference was analyzed using modified Poisson regression to account for the variable duration of the Treatment Period for each patient. The model included baseline ANC as a covariate, stratification factors of ECOG performance status (0 or 1 vs 2), sensitivity to 1st line treatment (sensitive or resistant), and treatment as fixed effects. The logarithm transformation of # of cycles was included as an offset variable in the modeling.||||0.0160
72579792|NCT04776148|144688929|OTHER|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by presence of liver metastasis (Yes/No).|Hazard Ratio (HR)|0.69||||0.0003|TWO_SIDED|95.0|0.56|0.85||One-sided p-value based on log-rank test stratified by presence of liver metastasis|Log Rank|||||0.85|0.56|0.0003
72411612|NCT00406029|144331703|SUPERIORITY_OR_OTHER||Difference in LS Means|0.3||||0.505|TWO_SIDED|95.0|-0.6|1.2|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.2|-0.6|0.505
72411613|NCT00406029|144331703|SUPERIORITY_OR_OTHER||Difference in LS Means|0.7||||0.114|TWO_SIDED|95.0|-0.2|1.7|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.7|-0.2|0.114
72411614|NCT00406029|144331703|SUPERIORITY_OR_OTHER||Difference in LS Means|0.9||||0.042|TWO_SIDED|95.0|0.0|1.8|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.8|0.0|0.042
72411615|NCT00406029|144331703|SUPERIORITY_OR_OTHER||Difference in LS Means|0.2||||0.684|TWO_SIDED|94.0|-0.8|1.3|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.3|-0.8|0.684
72411616|NCT00406029|144331703|SUPERIORITY_OR_OTHER||Difference in LS Means|0.4||||0.489|TWO_SIDED|95.0|-0.7|1.4|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.4|-0.7|0.489
72411617|NCT00406029|144331703|SUPERIORITY_OR_OTHER||Difference in LS Means|0.5||||0.305|TWO_SIDED|95.0|-0.5|1.6|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.6|-0.5|0.305
72411618|NCT00406029|144331703|SUPERIORITY_OR_OTHER||Difference in LS Means|0.4||||0.451|TWO_SIDED|95.0|-0.6|1.4|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.4|-0.6|0.451
72411619|NCT00406029|144331703|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.3||||0.68|TWO_SIDED|95.0|-1.5|1.0|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.0|-1.5|0.680
72411620|NCT00406029|144331703|SUPERIORITY_OR_OTHER||Difference in LS Means|0.4||||0.466|TWO_SIDED|95.0|-0.8|1.6|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.6|-0.8|0.466
72411621|NCT00406029|144331703|SUPERIORITY_OR_OTHER||Difference in LS Means|0.5||||0.45|TWO_SIDED|95.0|-0.8|1.7|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.7|-0.8|0.450
72411622|NCT00406029|144331703|SUPERIORITY_OR_OTHER||Difference in LS Means|0.4||||0.523|TWO_SIDED|95.0|-0.8|1.6|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.6|-0.8|0.523
72411623|NCT00406029|144331703|SUPERIORITY_OR_OTHER||Difference in LS Means|0.6||||0.309|TWO_SIDED|95.0|-0.6|1.8|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.8|-0.6|0.309
72411624|NCT00406029|144331703|SUPERIORITY_OR_OTHER||Difference in LS Means|0.8||||0.136|TWO_SIDED|95.0|-0.3|1.9|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.9|-0.3|0.136
72411625|NCT00406029|144331703|SUPERIORITY_OR_OTHER||Difference in LS Means|0.9||||0.106|TWO_SIDED|95.0|-0.2|2.1|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.||2.1|-0.2|0.106
72411626|NCT00406029|144331703|SUPERIORITY_OR_OTHER||Difference in LS Means|0.9||||0.144|TWO_SIDED|95.0|-0.3|2.1|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.||2.1|-0.3|0.144
72411627|NCT00406029|144331703|SUPERIORITY_OR_OTHER||Difference in LS Means|0.0||||0.954|TWO_SIDED|95.0|-1.1|1.1|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.1|-1.1|0.954
72411628|NCT00406029|144331703|SUPERIORITY_OR_OTHER||Difference in LS Means|0.8||||0.152|TWO_SIDED|95.0|-0.3|1.8|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.8|-0.3|0.152
72411629|NCT00406029|144331703|SUPERIORITY_OR_OTHER||Difference in LS Means|1.4||||0.012|TWO_SIDED|95.0|0.3|2.4|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.||2.4|0.3|0.012
72411630|NCT00406029|144331703|SUPERIORITY_OR_OTHER||Difference in LS Means|1.2||||0.025|TWO_SIDED|95.0|0.2|2.3|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.||2.3|0.2|0.025
72411631|NCT00406029|144331703|SUPERIORITY_OR_OTHER||Difference in LS Means|0.9||||0.151|TWO_SIDED|95.0|-0.3|2.2|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.||2.2|-0.3|0.151
72411632|NCT00406029|144331703|SUPERIORITY_OR_OTHER||Difference in LS Means|0.7||||0.235|TWO_SIDED|95.0|-0.5|1.9|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.9|-0.5|0.235
72579793|NCT04776148|144688930|OTHER|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate.|Hazard Ratio (HR)|1.15||||0.7421|TWO_SIDED|85.0|0.75|1.77||One-sided p-value based on log-rank test.|Log Rank|||||1.77|0.75|0.7421
72579794|NCT04776148|144688931|OTHER||Difference in Percentage vs. SOC|8.7|||<|0.0001|TWO_SIDED|95.0|4.7|13.5|||Chi-squared||Based on Miettinen \& Nurminen method stratified by presence of liver metastasis|||13.5|4.7|<0.0001
72579795|NCT04776148|144688932|OTHER||Difference in Percentage vs. SOC|3.3||||0.2456|TWO_SIDED|95.0|-7.7|14.3|||Chi-squared||Based on Miettinen \& Nurminen method.|||14.3|-7.7|0.2456
72411633|NCT00406029|144331703|SUPERIORITY_OR_OTHER||Difference in LS Means|1.7||||0.007|TWO_SIDED|95.0|0.5|2.9|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.||2.9|0.5|0.007
72411634|NCT00406029|144331703|SUPERIORITY_OR_OTHER||Difference in LS Means|1.3||||0.033|TWO_SIDED|95.0|0.1|2.5|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.||2.5|0.1|0.033
72411635|NCT00406029|144331703|SUPERIORITY_OR_OTHER||Difference in LS Means|0.2||||0.757|TWO_SIDED|95.0|-0.9|1.2|||ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.2|-0.9|0.757
72411636|NCT00406029|144331703|SUPERIORITY_OR_OTHER||Difference in LS Means|0.5||||0.341|TWO_SIDED|95.0|-0.5|1.6|||ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.6|-0.5|0.341
72545218|NCT01335464|144619497|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|125.26|STANDARD_ERROR_OF_MEAN|24.209|<|0.0001|TWO_SIDED|95.0|77.68|172.84||The objective of this trial was to assess the superiority of nintedanib 150 mg bid compared to placebo on the annual rate of decline in FVC.|Random coefficient regression|The Roger-Kenward approximation was used to estimate denominators degrees of freedom.|"Within-patient errors are modelled by an Unstructured variance-covariance matrix.~Inter-individual variability is modelled by a Variance-components variance-covariance matrix~Nintedanib 150 mg bid versus Placebo"|"Random coefficient regression with fixed effects for treatment, gender, age, height and random effect of patient specific intercept and time.~A hierarchical procedure was used in order to demonstrate the superiority of nintedanib over placebo for one primary and two key secondary endpoints.~The consecutive steps of the hierarchy were only considered if the previous step was significant at the one-sided 2.5% level and the results were in favour of nintedanib."||172.84|77.68|<0.0001
72545219|NCT01335464|144619498|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|1.248||0.9657|TWO_SIDED|95.0|-2.5|2.4|||Mixed Models Analysis||"Within-patient errors are modelled by compound symmetry covariance matrix~Nintedanib 150 mg bid versus Placebo"|Mixed Model for Repeated Measures (MMRM), with fixed effects for treatment, visit, treatment-by-visit, baseline SGRQ Total score, baseline SGRQ Total score-by-visit and random effect for patient.||2.40|-2.50|0.9657
72545220|NCT01335464|144619499|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.15||||0.6728|TWO_SIDED|95.0|0.54|2.42|||Log Rank||Nintedanib 150 mg bid versus Placebo|Hazard Ratio is based on a Cox´s regression model with terms for treatment, gender, age and height||2.42|0.54|0.6728
72545221|NCT01335464|144619500|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|109.93|STANDARD_ERROR_OF_MEAN|19.708|<|0.0001|TWO_SIDED|95.0|71.27|148.59|||Mixed Models Analysis||"Within-patient errors are modelled by compound symmetry covariance matrix.~Nintedanib 150 mg bid versus Placebo"|Based on Mixed Model for Repeated Measures (MMRM), with fixed effects for treatment, visit, gender, age, height, treatment-by-visit, baseline FVC, baseline FVC-by-visit and random effect for patient.||148.59|71.27|<0.0001
72579796|NCT04776148|144688939|OTHER||Difference in least squares means|2.71||||0.1553|TWO_SIDED|95.0|-1.03|6.46||Based on a cLDA model with the PRO scores as the response variable with covariates for treatment by study visit interaction and stratification factor presence of liver metastasis (Yes/No).|cLDA model|||||6.46|-1.03|0.1553
72579797|NCT04776148|144688940|OTHER||Difference in LS means|1.16||||0.4967|TWO_SIDED|95.0|-2.19|4.51||Based on a cLDA model with the PRO scores as the response variable with covariates for treatment by study visit interaction and stratification factor presence of liver metastasis (Yes/No).|cLDA model|||||4.51|-2.19|0.4967
72579798|NCT04776148|144688941|OTHER||Difference in LS means|3.36||||0.2271|TWO_SIDED|95.0|-2.1|8.82||Based on a cLDA model with the PRO scores as the response variable with covariates for treatment by study visit interaction and stratification factor presence of liver metastasis (Yes/No).|cLDA model|||||8.82|-2.10|0.2271
72579799|NCT04776148|144688942|OTHER||Difference in LS means|-5.46||||0.0264|TWO_SIDED|95.0|-10.27|-0.65||Based on a cLDA model with the PRO scores as the response variable with covariates for treatment by study visit interaction and stratification factor presence of liver metastasis (Yes/No).|cLDA model|||||-0.65|-10.27|0.0264
72579800|NCT04776148|144688943|OTHER||Hazard Ratio (HR)|0.91||||0.4338|TWO_SIDED|95.0|0.73|1.14|||Regression, Cox|Two-sided p-value based on log-rank test stratified by presence of liver metastasis (Yes/No).||||1.14|0.73|0.4338
72579801|NCT04776148|144688944|OTHER||Hazard Ratio (HR)|1.1||||0.4316|TWO_SIDED|95.0|0.87|1.38||Two-sided p-value based on log-rank test stratified by presence of liver metastasis (Yes/No).|Regression, Cox|||||1.38|0.87|0.4316
72579802|NCT04776148|144688945|OTHER||Hazard Ratio (HR)|1.06||||0.5587|TWO_SIDED|95.0|0.85|1.32|||Regression, Cox|Two-sided p-value based on log-rank test stratified by presence of liver metastasis (Yes/No).||||1.32|0.85|0.5587
72579803|NCT04776148|144688946|OTHER||Hazard Ratio (HR)|0.95||||0.6794|TWO_SIDED|95.0|0.73|1.23||Two-sided p-value based on log-rank test stratified by presence of liver metastasis (Yes/No).|Regression, Cox|||||1.23|0.73|0.6794
72579804|NCT04776148|144688947|SUPERIORITY||Hazard Ratio (HR)|0.83||||0.0379|TWO_SIDED|95.0|0.68|1.02|||Log Rank|One-sided p-value based on log-rank test stratified by presence of liver metastasis (Yes/No).|HR=Lenvatinib + pembrolizumab vs. SOC treatment|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by presence of liver metastasis (Yes/No).||1.02|0.68|0.0379
72579805|NCT04776148|144688948|SUPERIORITY||Hazard Ratio (HR)|0.92||||0.3574|TWO_SIDED|95.0|0.6|1.42|||Log Rank|One-sided p-value based on log-rank test.|HR=Lenvatinib + pembrolizumab vs. SOC treatment|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate.||1.42|0.60|0.3574
72579806|NCT03367572|144688949|SUPERIORITY||Mean Difference (Net)|0.7056||||0.008|TWO_SIDED||||||ANOVA|||||||0.008
72579807|NCT03367572|144688949|SUPERIORITY||Mean Difference (Net)|1.1486|||<|0.001|TWO_SIDED||||||ANOVA|||||||<0.001
72579808|NCT03367572|144688950|SUPERIORITY||Mean Difference (Net)|0.4468||||0.01|TWO_SIDED||||||ANOVA|||||||0.010
72579809|NCT03367572|144688950|SUPERIORITY||Mean Difference (Net)|0.5632||||0.001|TWO_SIDED||||||ANOVA|||||||0.001
72579810|NCT03367572|144688951|SUPERIORITY||Mean Difference (Net)|-0.59||||0.019|TWO_SIDED||||||t-test, 2 sided|||"Secondary Aim 1 is to determine if olanzapine is more effective than prochlorperazine in controlling nausea at Cycle 2 in participants who experienced CINV at Cycle 1 when used in combination with netupitant, palonosetron and dexamethasone.~This will be assessed by estimating the contrast D = (3 - 1) - (2 - 1), where 3 is the Arm 3 mean, 2 is the Arm 2 mean, and 1 is the Control mean, and testing whether D = 0 versus the one-sided alternative hypothesis that D \> 0."||||0.019
72579811|NCT03367572|144688952|SUPERIORITY||Odds Ratio (OR)|1.31||||0.386|TWO_SIDED|97.5|0.65|2.66||prochlorperazine arm statistics|Regression, Logistic|||||2.66|0.65|0.386
72579812|NCT03367572|144688952|SUPERIORITY||Odds Ratio (OR)|0.16||||0.036|TWO_SIDED|97.5|0.02|1.13||olanzapine arm statistics|Regression, Logistic|||||1.13|0.02|0.036
72545222|NCT01335464|144619501|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.02|STANDARD_ERROR_OF_MEAN|0.753|<|0.0001|TWO_SIDED|95.0|2.54|5.5|||Mixed Models Analysis||"Within-patient errors are modelled by compound symmetry covariance matrix.~Nintedanib 150 mg bid versus Placebo"|Based on Mixed Model for Repeated Measures (MMRM), with fixed effects for treatment, visit, gender, age, height, treatment-by-visit, baseline FVC, baseline FVC-by-visit and random effect for patient.||5.50|2.54|<0.0001
72545223|NCT01335464|144619502|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.22|STANDARD_ERROR_OF_MEAN|0.564|<|0.0001|TWO_SIDED|95.0|2.11|4.33|||Mixed Models Analysis||"Within-patient errors are modelled by compound symmetry covariance matrix.~Nintedanib 150 mg bid versus Placebo"|Based on Mixed Model for Repeated Measures (MMRM), with fixed effects for treatment, visit, gender, age, height, treatment-by-visit, baseline FVC \[%predicted\], baseline FVC \[%predicted\]-by-visit and random effect for patient.||4.33|2.11|<0.0001
72545224|NCT01335464|144619503|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.0|STANDARD_ERROR_OF_MEAN|0.753|<|0.0001|TWO_SIDED|95.0|2.52|5.48|||Mixed Models Analysis||"Within-patient errors are modelled by compound symmetry covariance matrix.~Nintedanib 150 mg bid versus Placebo"|Based on Mixed Model for Repeated Measures (MMRM), with fixed effects for treatment, visit, gender, age, height, treatment-by-visit, baseline FVC \[%predicted\], baseline FVC \[%predicted\]-by-visit and random effect for patient.||5.48|2.52|<0.0001
72545225|NCT01335464|144619506|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.914||||0.0007|TWO_SIDED|95.0|1.32|2.79|||Regression, Logistic||Nintedanib 150 mg bid versus Placebo|Logistic regression with terms treatment, age, gender, height and baseline FVC % predicted||2.79|1.32|0.0007
72545226|NCT01335464|144619507|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.847||||0.001|TWO_SIDED|95.0|1.28|2.66|||Regression, Logistic||Nintedanib 150 mg bid versus Placebo|Logistic regression with terms treatment, age, gender, height and baseline FVC % predicted||2.66|1.28|0.0010
72545227|NCT01335464|144619508|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.84||||0.4298|TWO_SIDED|95.0|0.55|1.29|||Regression, Logistic||Nintedanib 150 mg bid versus Placebo|Logistic regression with terms treatment, baseline SGRQ total score||1.29|0.55|0.4298
72545228|NCT01335464|144619509|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.32|STANDARD_ERROR_OF_MEAN|1.744||0.1832|TWO_SIDED|95.0|-5.74|1.1|||Mixed Models Analysis||"Within-patient errors are modelled by compound symmetry covariance matrix.~Nintedanib 150 mg bid versus Placebo"|Mixed Model for Repeated Measures (MMRM), with fixed effects for treatment, visit, treatment-by-visit, baseline SGRQ Symptoms component, baseline SGRQ Symptoms component-by-visit and random effect for patient.||1.10|-5.74|0.1832
72545229|NCT01335464|144619510|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.86|STANDARD_ERROR_OF_MEAN|1.446||0.551|TWO_SIDED|95.0|-1.97|3.7|||Mixed Models Analysis||"Within-patient error are modelled by compound symmetry covariance matrix~Nintedanib 150 mg bid versus Placebo"|Mixed Model for Repeated Measures (MMRM), with fixed effects for treatment, visit, treatment-by-visit, baseline SGRQ impact component, baseline SGRQ Impact component-by-visit and random effect for patient||3.70|-1.97|0.5510
72545230|NCT01335464|144619511|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.19|STANDARD_ERROR_OF_MEAN|1.427||0.4049|TWO_SIDED|95.0|-3.99|1.61|||Mixed Models Analysis||"Within-patient errors are modelled by compound symmetry covariance matrix~Nintedanib 150 mg bid versus Placebo"|Mixed Model for Repeated Measures (MMRM), with fixed effects for treatment, visit, treatment-by-visit, baseline SGRQ Activities component, baseline SGRQ Activities component-by-visit and random effect for patient||1.61|-3.99|0.4049
72545231|NCT01335464|144619512|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.78|STANDARD_ERROR_OF_MEAN|1.289||0.5446|TWO_SIDED|95.0|-3.31|1.75|||Mixed Models Analysis||"Within-patient errors are modelled by compound symmetry covariance matrix.~Nintedanib 150mg versus placebo"|Mixed Model for Repeated Measures (MMRM), with fixed effects for treatment, visit, treatment-by-visit, baseline SGRQ-I Total score, baseline SGRQ-I Total score-by-visit and random effect for patient.||1.75|-3.31|0.5446
72579813|NCT02731638|144688957|SUPERIORITY||Odds Ratio (OR)|1.82||||0.26|TWO_SIDED|95.0|0.65|5.23|||Regression, Logistic|Bias-corrected logistic regression, accounting for baseline culture status||||5.23|0.65|0.26
72579814|NCT02731638|144688958|SUPERIORITY||Coefficient|1.6||||0.25|TWO_SIDED|95.0|-1.2|4.4|||Regression, Linear||Positive coefficients of the logMAR value indicated worsened visual acuity|||4.4|-1.2|0.25
72579815|NCT02731638|144688958|SUPERIORITY||Coefficient|0.5||||0.75|TWO_SIDED|95.0|-2.6|3.6|||Regression, Linear||Positive coefficients of the logMAR value indicate worsened visual acuity|||3.6|-2.6|0.75
72579816|NCT05878093|144688980|SUPERIORITY|A hierarchical procedure was used to control type I error and handle primary and first 4 secondary endpoints (reported sequentially) analyses at a 2-sided significance level of 0.05.|Least square mean difference|-1.84|||<|0.0001|TWO_SIDED|95.0|-2.53|-1.15|||ANCOVA||Data was analyzed by fitting an analysis of covariance (ANCOVA) model with the corresponding baseline value, treatment group, and screening blood eosinophil count strata as covariates.|||-1.15|-2.53|<0.0001
72579817|NCT05878093|144688981|SUPERIORITY|A hierarchical procedure was used to control type I error and handle primary and first 4 secondary endpoints (reported sequentially) analyses at a 2-sided significance level of 0.05.|Least square mean difference|-0.54||||0.0126|TWO_SIDED|95.0|-0.97|-0.12|||ANCOVA||Data was analyzed by fitting an ANCOVA model with the corresponding baseline value, treatment group, and screening blood eosinophil count strata as covariates.|||-0.12|-0.97|0.0126
72579818|NCT05878093|144688982|SUPERIORITY|A hierarchical procedure was used to control type I error and handle primary and first 4 secondary endpoints (reported sequentially) analyses at a 2-sided significance level of 0.05.|Least square mean difference|-1.68||||0.0008|TWO_SIDED|95.0|-2.67|-0.69|||ANCOVA||Data was analyzed by fitting an ANCOVA model with the corresponding baseline value, treatment group, and screening blood eosinophil count strata as covariates.|||-0.69|-2.67|0.0008
72579819|NCT05878093|144688983|SUPERIORITY|A hierarchical procedure was used to control type I error and handle primary and first 4 secondary endpoints (reported sequentially) analyses at a 2-sided significance level of 0.05.|Least square mean difference|-0.62||||0.0072|TWO_SIDED|95.0|-1.08|-0.17|||ANCOVA||Data was analyzed by fitting an ANCOVA model with the corresponding baseline value, treatment group, and screening blood eosinophil count strata as covariates.|||-0.17|-1.08|0.0072
72579820|NCT05878093|144688984|SUPERIORITY|A hierarchical procedure was used to control type I error and handle primary and first 4 secondary endpoints (reported sequentially) analyses at a 2-sided significance level of 0.05.|Least square mean difference|-9.52||||0.0104|TWO_SIDED|95.0|-16.81|-2.24|||ANCOVA||Data was analyzed by fitting an ANCOVA model with the corresponding baseline value, treatment group, and screening blood eosinophil count strata as covariates.|||-2.24|-16.81|0.0104
72579821|NCT03690388|144688992|SUPERIORITY||Hazard Ratio (HR)|0.22|||<|0.0001|TWO_SIDED|96.0|0.13|0.36|||Log Rank|||||0.36|0.13|< 0.0001
72411637|NCT00406029|144331703|SUPERIORITY_OR_OTHER||Difference in LS Means|1.2||||0.024|TWO_SIDED|95.0|0.2|2.3|||ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.||2.3|0.2|0.024
72545232|NCT01335464|144619513|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.88|STANDARD_ERROR_OF_MEAN|1.77||0.6203|TWO_SIDED|95.0|-4.35|2.6|||Mixed Models Analysis||"Within-patient errors are modelled by compound symmetry covariance matrix.~Nintedanib 150mg versus placebo"|Mixed Model for Repeated Measures (MMRM), with fixed effects for treatment, visit, treatment-by-visit, baseline SOBQ score, baseline SOBQ score-by-visit and random effect for patient.||2.60|-4.35|0.6203
72545233|NCT01335464|144619514|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.24|STANDARD_ERROR_OF_MEAN|1.803||0.8942|TWO_SIDED|95.0|-3.78|3.3|||Mixed Models Analysis||"Within- patient errors are modelled by compound symmetry covariance matrix.~Nintedanib 150 mg versus Placebo"|Mixed Model for Repeated Measures (MMRM), with fixed effects for treatment, visit, treatment-by-visit, baseline CASA-Q Cough symptoms score, baseline CASA-Q Cough symptoms score-by-visit and random effect for patient.||3.30|-3.78|0.8942
72545234|NCT01335464|144619515|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.64|STANDARD_ERROR_OF_MEAN|1.596||0.3042|TWO_SIDED|95.0|-1.49|4.77|||Mixed Models Analysis||"Within-patient errors are modelled by compound symmetry covariance matrix~Nintedanib 150 mg versus Placebo"|Mixed Model for Repeated Measures (MMRM), with fixed effects for treatment, visit, treatment-by-visit, baseline CASA-Q Cough impact score, baseline CASA-Q Cough impact score-by-visit and random effect for patient.||4.77|-1.49|0.3042
72545235|NCT01335464|144619516|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.276||||0.1818|TWO_SIDED|95.0|0.89|1.83|||Regression, Logistic||Nintedanib 150mg versus placebo|Logistic regression with term treatment||1.83|0.89|0.1818
72545236|NCT01335464|144619518|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.17||||0.6793|TWO_SIDED|95.0|0.56|2.46|||Normal distribution|Risk ratio was calculated as the ratio of risk of exacerbation in both treatment groups.|Nintedanib 150mg bid versus placebo|The log of the risk ratio was assumed to follow a normal distribution with mean 0 and variance equal to the sum of the reciprocals of the number of patients with at least one exacerbation in each treatment arm.||2.46|0.56|0.6793
72545237|NCT01335464|144619519|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.63||||0.288|TWO_SIDED|95.0|0.29|1.36|||Log Rank||Nintedanib 150mg bid versus placebo|Hazard ratio is based on a Cox´s regression model with terms for treatment, gender, age and height||1.36|0.29|0.2880
72545238|NCT01335464|144619520|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.61||||0.3515|TWO_SIDED|95.0|0.25|1.47|||Log Rank||Nintedanib 150mg versus placebo|Hazard ratio is based on Cox´s regression model with terms for treatment, gender, age and height||1.47|0.25|0.3515
72545239|NCT01335464|144619521|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.68||||0.4869|TWO_SIDED|95.0|0.26|1.82|||Log Rank||Nintedanib 150mg bid versus placebo|Hazard ratio is based on a Cox´s regression model with terms for treatment, gender, age and height||1.82|0.26|0.4869
72545240|NCT01335464|144619522|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.73||||0.443|TWO_SIDED|95.0|0.36|1.51|||Log Rank||Nintedanib 150mg versus placebo|Hazard ratio is based on Cox´s regression model with terms for treatment, gender, age and height||1.51|0.36|0.4430
72545241|NCT01335464|144619523|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.81||||0.3558|TWO_SIDED|95.0|0.52|1.25|||Log Rank||Nintedanib 150mg bid versus placebo|Hazard ratio is based on Cox´s regression model with terms for treatment, gender, age and height||1.25|0.52|0.3558
72545242|NCT01335464|144619524|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.29|STANDARD_ERROR_OF_MEAN|0.181||0.1138|TWO_SIDED|95.0|-0.07|0.64|||Mixed Models Analysis||"Within-patient errors are modelled by compound symmetry covariance matrix.~Nintedanib 150mg bid versus placebo"|Mixed Model for Repeated Measures (MMRM), with fixed effects for treatment, visit, gender, age, height, treatment-by-visit, baseline SpO2, baseline SpO2-by-visit and random effect for patient.||0.64|-0.07|0.1138
72545243|NCT01335464|144619525|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.015|STANDARD_ERROR_OF_MEAN|0.0896||0.865|TWO_SIDED|95.0|-0.191|0.161|||Mixed Models Analysis||"Within-patient errors are modelled by compound symmetry covariance matrix.~Nintedanib 150mg bid versus placebo"|Mixed Model for Repeated Measures with fixed effects for treatment, visit, gender, age, height, treatment-by-visit, baseline DLCO (HGB Corrected) \[mmol/min/kPa\], baseline DLCO (HGB Corrected) \[mmol/min/kPa\]-by-visit and random effect for patient.||0.161|-0.191|0.8650
72545244|NCT00696709|144619554|OTHER||||||<|0.0001||||||The statistical criterion for significance requires that the lower bound of the 2-sided 95% confidence interval of the geometric mean fold rise in vaccine recipients is \>1.0.|Longitudinal regression (LR)|Calculated based on LR model (adjusting for pre-vaccination immunogenicity level and incomplete data) with visit as covariate.||||||<0.0001
72545245|NCT00696709|144619555|OTHER||||||<|0.0001||||||The statistical criterion for significance requires that the lower bound of the 2-sided 95% confidence interval of the geometric mean fold rise in vaccine recipients is \>1.0.|Longitudinal regression (LR)|Calculated based on LR model (adjusting for pre-vaccination immunogenicity level and incomplete data) with visit as covariate.||||||<0.0001
72545246|NCT00696709|144619556|OTHER||||||<|0.0001||||||The statistical criterion for significance requires that the lower bound of the 2-sided 95% confidence interval of the geometric mean fold rise in vaccine recipients is \>1.0.|Longitudinal regression (LR)|Calculated based on LR model (adjusting for pre-vaccination immunogenicity level and incomplete data) with visit as covariate.||||||<0.0001
72545247|NCT00696709|144619557|OTHER|The statistical criterion for significance requires that the lower bound of the 2-sided 95% confidence interval of the geometric mean fold rise in vaccine recipients is \>1.0.|||||<|0.0001|||||||Longitudinal data analysis (LDA)|LDA with log-transformed VZV responses at each visit as response variables and visit as covariate.||||||<0.0001
72545248|NCT00696709|144619558|OTHER||Difference in Percentage|0.0|||||TWO_SIDED|95.0|-10.8|5.7|||||Miettinen \& Nurminen|||5.7|-10.8|
72545249|NCT00696709|144619558|OTHER||Difference in Percentage|1.6|||||TWO_SIDED|95.0|-9.2|8.8|||||Miettinen \& Nurminen|||8.8|-9.2|
72545250|NCT00696709|144619559|OTHER||Difference in Percentage|35.9|||<|0.001|TWO_SIDED|95.0|15.2|52.6|||Miettinen & Nurminen|||||52.6|15.2|<0.001
72545251|NCT00696709|144619559|OTHER||Difference in Percentage|40.4|||<|0.001|TWO_SIDED|95.0|19.6|57.0|||Miettinen & Nurminen|||||57.0|19.6|<0.001
72545252|NCT00696709|144619560|OTHER||Difference in Percentage|-4.7|||||TWO_SIDED|95.0|-25.3|16.1|||||Miettinen \& Nurminen|||16.1|-25.3|
72579822|NCT04100018|144688997|SUPERIORITY||Cox Proportional Hazard|0.96||||0.5901|TWO_SIDED|99.0|0.77|1.19||Boundary for statistical significance p-value \< 0.01|Log Rank|Stratification factor is visceral disease (YES vs NO) as entered in the IRT.||||1.19|0.77|0.5901
72579823|NCT04100018|144688998|SUPERIORITY||Cox Proportional Hazard|1.09||||0.3572|TWO_SIDED|99.41|0.84|1.43||Boundary for statistical significance p-value \< 0.0059. Additional accuracy for p-value: 0.005866.|Log Rank||Stratification factor is visceral disease (YES vs NO) as entered in the IRT.|||1.43|0.84|0.3572
72579824|NCT04100018|144688999|SUPERIORITY||Adjusted Difference|3.8|||||TWO_SIDED|95.0|-4.5|12.1|||||Strata adjusted difference in objective response rate based on DerSimonian and Laird method. Stratified by visceral disease (YES vs NO) as entered in the IRT.|||12.1|-4.5|
72579825|NCT04100018|144689002|SUPERIORITY||Percentage Difference|0.9|||||TWO_SIDED|95.0|-5.2|7.0|||||Strata adjusted difference in objective response rate based on DerSimonian and Laird method. Stratified by visceral disease (YES vs NO) as entered in the IRT.|||7.0|-5.2|
72545253|NCT00696709|144619560|OTHER||Difference in Percentage|4.1|||||TWO_SIDED|95.0|-16.9|24.9|||||Miettinen \& Nurminen|||24.9|-16.9|
72545254|NCT00696709|144619561|OTHER||Difference in Percentage|1.6||||0.48|TWO_SIDED|95.0|-9.3|8.4|||Miettinen & Nurminen|||||8.4|-9.3|0.480
72545255|NCT00696709|144619561|OTHER||Difference in Percentage|1.6||||0.469|TWO_SIDED|95.0|-9.2|8.8|||Miettinen & Nurminen|||||8.8|-9.2|0.469
72545256|NCT00696709|144619562|OTHER||Difference in Percentage|0.0|||||TWO_SIDED|95.0|-10.8|5.7|||||Miettinen \& Nurminen|||5.7|-10.8|
72545257|NCT00696709|144619562|OTHER||Difference in Percentage|0.0|||||TWO_SIDED|95.0|-10.8|6.0|||||Miettinen \& Nurminen|||6.0|-10.8|
72545258|NCT01227668|144619567|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.57||||0.097|TWO_SIDED|95.0|0.28|1.12|||Stratified log rank|||||1.12|0.28|0.097
72545259|NCT01227668|144619568|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.4||||0.051|TWO_SIDED|95.0|-8.82|0.02||For secondary endpoints, hierarchical testing aimed to keep the overall experiment-wise type I error rate to \<=0.05. Difference in chg from BL was tested at 0.05 significance only if APR arm significantly differed vs placebo from primary analysis.|ANCOVA|||||0.02|-8.82|0.051
72545260|NCT01227668|144619569|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6||||0.09|TWO_SIDED|95.0|-1.3|0.1||Treatment diff in chg from BL to endpnt in IS score was tested at 0.05 signif only if ARP arm signif differed vs pb from PA. Thus, if ARP arm signif differed vs pb in IS score, treatment diff in mean CGI-I score at endpnt was tested at 0.05 signfnce.|ANCOVA|||||0.1|-1.3|0.090
72545261|NCT01033864|144619573|SUPERIORITY_OR_OTHER|||||||0.8055|||||||Wilcoxon (Mann-Whitney)|||||||0.8055
72545262|NCT01033864|144619574|SUPERIORITY_OR_OTHER|||||||0.2548|||||||Wilcoxon (Mann-Whitney)|||||||0.2548
72545263|NCT01033864|144619575|SUPERIORITY_OR_OTHER|||||||0.4417|||||||Wilcoxon (Mann-Whitney)|||||||0.4417
72545264|NCT01033864|144619576|SUPERIORITY_OR_OTHER|||||||0.0455|||||||Wilcoxon (Mann-Whitney)|||||||0.0455
72545265|NCT01033864|144619577|SUPERIORITY_OR_OTHER|||||||0.23|||||||Wilcoxon (Mann-Whitney)|||||||0.2300
72545266|NCT01033864|144619578|SUPERIORITY_OR_OTHER|||||||0.0106|||||||Wilcoxon (Mann-Whitney)|||||||0.0106
72579826|NCT04100018|144689003|SUPERIORITY||Cox Proportional Hazard|1.0|||||TWO_SIDED|95.0|0.86|1.16|||||Stratification factor is visceral disease (YES vs NO) as entered in the IRT.|||1.16|0.86|
72579827|NCT05736861|144689014|SUPERIORITY|Decision rule based on Bayesian posterior probability of efficacy. The decision threshold was a posterior probability of 0.95. A prespecified skeptical prior for the treatment effect was used to preserve type I error below 0.05.|Hazard Ratio (HR)|1.07|||||TWO_SIDED|95.0|0.96|1.17|||||The interval is a highest-density credible interval. Adjustment variables: randomization, age, sex, duration of symptoms prior to study drug, calendar time, vaccination status, geographic region, call center indicator, and baseline symptom severity.|||1.17|0.96|
72411638|NCT00406029|144331703|SUPERIORITY_OR_OTHER||Difference in LS Means|1.1||||0.049|TWO_SIDED|95.0|0.0|2.1|||ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.||2.1|0.0|0.049
72545267|NCT01033864|144619579|SUPERIORITY_OR_OTHER|||||||0.3401|||||||Wilcoxon (Mann-Whitney)|||||||0.3401
72545268|NCT01033864|144619580|SUPERIORITY_OR_OTHER|||||||0.0074|||||||Wilcoxon (Mann-Whitney)|||||||0.0074
72545269|NCT01033864|144619581|SUPERIORITY_OR_OTHER|||||||0.0002|||||||Wilcoxon (Mann-Whitney)|||||||0.0002
72545270|NCT01709383|144619583|SUPERIORITY_OR_OTHER|||||||0.57|||||||Mixed Models Analysis|||||||.57
72545271|NCT01709383|144619585|SUPERIORITY_OR_OTHER|||||||0.64|||||||Mixed Models Analysis|||||||.64
72545272|NCT00982410|144619635|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6489|STANDARD_ERROR_OF_MEAN|0.29|<|0.05|TWO_SIDED|95.0|-1.2255|-0.0722|||Mixed Models Analysis|Adjusted for baseline NRS-1 pain level. Time interval and therapy session block were utilized to model the variance.|EUC (Arm 2) was referent. Estimation parameter = value for Cognitive Behavior Treatment group minus value for Educational Support group.|Ho: There was no difference in average pain level across the follow-up period, between CBT group and Educational support group.||-0.07220|-1.2255|<0.05
72545273|NCT00982410|144619636|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.25|||<|0.05|TWO_SIDED|95.0|0.034|0.466|||Mixed Models Analysis|Adjusted for baseline WHY MPI General Activity score. Time interval and therapy session block were utilized to model the variance.|Education Support group was referent. Mean difference = value for CBT group minus value for Educational Support group.|||0.466|0.034|<0.05
72545274|NCT00982410|144619637|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||Mixed Models Analysis|Adjusted for baseline #days of alcohol use. Time interval and therapy session block were utilized to model the variance.||||||<0.01
72545275|NCT00982410|144619638|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Mixed Models Analysis|Adjusted for baseline #days illicit drug use. Time interval and therapy session block were utilized to model the variance. EUC group was referent.||||||>0.05
72545276|NCT00982410|144619639|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.66|||>|0.05|TWO_SIDED|95.0|-5.0|14.32|||Mixed Models Analysis|Adjusted for baseline pain tolerance. Time interval and therapy session block were utilized to model the variance.|Educational Support group = referent. Estimation parameter = CBT group minus EUC group, adjusted for BL pain tolerance. Cold tolerance distribution had ceiling and floor effects; and, \~20% of participants refused cold tolerance task in follow-up.|||14.32|-5.00|>0.05
72545277|NCT00982410|144619640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.28|||<|0.005|TWO_SIDED|95.0|3.93|16.63|||Mixed Models Analysis|Adjusted for baseline CPSS PSE score. Time interval and therapy session block were utilized to model the variance. EUC group was referent.|Adjusted for baseline CPSS PSE score. EUC group was referent. Mean difference = value for CBT minus value for Educational Support group.|||16.63|3.93|<0.005
72545278|NCT01016652|144619664|NON_INFERIORITY_OR_EQUIVALENCE|This is a non-inferiority analysis, with \>=5 CLUE points being the non-inferiority margin.|Mean Difference (Final Values)|-4.14|STANDARD_ERROR_OF_MEAN|0.12|||TWO_SIDED|95.0|-9.86|1.59|||Mixed Models Analysis|||"Ho: There are not significant differences between the two lenses (etafilcon A multifocal (test) vs. etafilcon A sphere (control)for Vision quality.~Ha: The test lens is greater than or equal by 5 CLUE points than the control lense."||1.59|-9.86|
72545279|NCT01016652|144619665|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin will be exceeded if the test lens is greater than or equal to 0.25D over the control lens.|Mean Difference (Net)|0.01|STANDARD_ERROR_OF_MEAN|0.06|||TWO_SIDED|95.0|-0.09|0.1|||Mixed Models Analysis|||"Ho: There is not a difference between the test lens and the control lens for amplitude of accommodation.~Ha: Monocular amplitude of accommodation of the test lens is significantly better than the control lens"||0.10|-0.09|
72545280|NCT04014959|144619670|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|t(35)= -4.47||Statistical analysis of fMRI-guided TMS evoked subgenual anterior cingulate responses (fMRI BOLD) change at Pre-tx/Pre-iTBS. Statistics are from one-sample T-tests vs. 0, 2-tailed. Negative t-values represent negative mean fMRI BOLD percent signal change. Alternative hypothesis: true mean is not equal to 0.||||<0.001
72545281|NCT04014959|144619670|SUPERIORITY|||||||0.005|||||||t-test, 2 sided|t(35)= -3.00||Statistical analysis of fMRI-guided TMS evoked subgenual anterior cingulate responses (fMRI BOLD) change at Pre-tx/Post-iTBS. Statistics are from one-sample T-tests vs. 0, 2-tailed. Negative t-values represent negative mean fMRI BOLD percent signal change. Alternative hypothesis: true mean is not equal to 0.||||0.005
72545282|NCT04014959|144619670|SUPERIORITY|||||||0.005|||||||t-test, 2 sided|t(35)= -2.96||Statistical analysis of fMRI-guided TMS evoked subgenual anterior cingulate responses (fMRI BOLD) change at Post-tx/Pre-iTBS. Statistics are from one-sample T-tests vs. 0, 2-tailed. Negative t-values represent negative mean fMRI BOLD percent signal change. Alternative hypothesis: true mean is not equal to 0.||||0.005
72545283|NCT04014959|144619670|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|t(35)= -5.05||Statistical analysis of fMRI-guided TMS evoked subgenual anterior cingulate responses (fMRI BOLD) change at Post-tx/Post-iTBS. Statistics are from one-sample T-tests vs. 0, 2-tailed. Negative t-values represent negative mean fMRI BOLD percent signal change. Alternative hypothesis: true mean is not equal to 0.||||<0.001
72545284|NCT04014959|144619672|OTHER|Statistics are an unadjusted linear regression of change in DASS-21 depression score on the pre-intervention TMS/fMRI evoked brain response.||||||0.007|||||||Regression, Linear|β = -33.60||Analysis to investigate the correlation between changes in DASS-21 Scores (Secondary Outcome) and Evoked Functional Brain Activity (Other Pre-specified Outcome) pre and post the 3-Day TMS Intervention Regimen.||||0.007
72545285|NCT02060461|144619673|OTHER|||||||0.003|||||||t-test, 2 sided|||Paired Students t-test of FS200 and IntraLase intraoperative flap thickness measurements obtained by ultrasound pachymetry||||.003
72545286|NCT02034799|144619674|NON_INFERIORITY_OR_EQUIVALENCE|The assumed proportion of success for SOC is 0.95 and the proportion of success for the Bioseal group at which the power is calculated is 0.95. A sample size of 112 subjects per group achieves 80% power to detect the non-inferiority margin difference between the group proportions of -0.10. One-sided significance level of 0.025 was used. Using drop-out rate of 10%, 125 subjects per treatment group were randomized for a total of 250 subjects.|Risk Difference (RD)|0.0781|||||TWO_SIDED|95.0|-0.048|0.199||||||H0: Delta \</= -0.1 HA: Delta \> -0.1 Delta is difference in proportion of successes between Bioseal and SOC gropus (Bioseal minus SOC). Success is defined as hemostasis at the TBS at 6 minutes following treatment application||0.199|-0.048|
72545287|NCT01133821|144619683|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||time effect for HRSD-17||||<0.0001
72545288|NCT01133821|144619684|SUPERIORITY||||||>|0.05|||||||Regression, Linear|Adjusted for baseline scores||||||>0.05
72545289|NCT03273387|144619733|SUPERIORITY|||||||0.008||||||95% Confidence interval 1.97 - 11.3 statistical significant if p\<0.05|t-test, 2 sided|t=2.988 df=18||||||0.008
72545290|NCT03273387|144619734|SUPERIORITY|||||||0.33||||||statistical significant if p \<0.05|two-way ANOVA|DF=3||||||0.33
72545291|NCT03273387|144619735|SUPERIORITY|||||||0.0002||||||95% Confidence interval 15.92 to 42.53 statistical significant if p \<0.05|t-test, 2 sided|t=4.598 df=19||||||0.0002
72545292|NCT01907087|144619736|OTHER|Inference is by an exact binomial test of the null hypothesis H0: Prob(response) \<= 0.50 vs. the alternative hypothesis H1: Prob(response) \> 0.50, where Prob(response) denotes the population probability of a response. The confidence interval is an exact interval with significance level α=0.05.|Proportion of responders|0.87||||0.0002|TWO_SIDED|95.0|0.66|0.97|||exact binomial test|||"Responder Analysis using ITT Population: Proportion of Subjects without an Unreversed Two-point Decline or Score of 0 in ML Scale Score at 48 Weeks.~A 'response' is defined as the absence of an unreversed two-point decline or score of 0 in the 0-to-6 point CLN2 score at 48 weeks."||0.97|0.66|0.0002
72545293|NCT01907087|144619736|OTHER|"Subject rate of decline per 48 weeks is estimated: (baseline CLN2 score - last CLN2 score)/(time elapsed in units of 48 weeks).~P-value computed as a two-sided t-test for the hypothesis H0: Rate=2.0 points lost/48 weeks vs. H1: Rate not equal 2.0 points lost/48 weeks."|Slope|0.4|STANDARD_DEVIATION|0.809|<|0.0001|TWO_SIDED|95.0|0.05|0.75|||t-test, 2 sided|||Slopes Analysis using ITT Population: Estimated Rate of Decline (300 mg Dosing Period).||0.75|0.05|<0.0001
72545294|NCT02180061|144619746|SUPERIORITY|||||||0.0216||||||One-sided p-value. The ORR was deemed clinically meaningful if the lower bound of the 95% confidence interval exceeded 10% (p\<0.0250).|Exact Binomial Distribution|||||||0.0216
72545295|NCT02491788|144619770|SUPERIORITY||Mean Difference (Final Values)|2.16|STANDARD_ERROR_OF_MEAN|0.75|<|0.05|TWO_SIDED||||||Mixed Models Analysis|||||||<0.05
72545296|NCT01464827|144619772|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.49||||0.406|TWO_SIDED|95.0|0.09|2.61||No adjustment for multiple comparison. Pre-specified 2-sided significance level of 0.05.|Regression, Logistic||Odds ratio: Group A : Group G|"The primary efficacy endpoint was the comparison of the percentage of treatment-naïve participants with SVR24 after treatment with 3 DAAs (at the 150 mg ABT-450 dose) and ribavirin for 8 weeks (Group A) versus 12 weeks (Group G).~Logistic regression with baseline log10 HCV RNA level, treatment group, Interleukin 28B genotype (CC or non-CC), HCV subgenotype (1a or non-1a), and geographic region (US or non-US) as predictors."||2.61|0.09|0.406
72545297|NCT01464827|144619773|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.4||||0.266|TWO_SIDED|95.0|0.08|2.02||No adjustment for multiple comparison. Pre-specified 2-sided significance level of 0.05.|Regression, Logistic||Odds ratio: Group A : Groups \[F + G + K + L\]|The percentage of participants with SVR24 after treatment for 8 weeks versus 12 weeks was compared using logistic regression with treatment group, baseline log10 HCV RNA level, HCV subgenotype (1a or non-1a), geographic region (US or non-US), Interleukin 28B genotype (CC or non-CC), and ABT-450/ritonavir dose and population (treatment-naïve or null-responders) as predictors.||2.02|0.08|0.266
72545298|NCT01464827|144619773|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.66||||0.525|TWO_SIDED|95.0|0.18|2.4||No adjustment for multiple comparison. Pre-specified 2-sided significance level of 0.05.|Regression, Logistic||Odds ratio: Group A : Groups \[H + I + M + N\]|The percentage of participants with SVR24 after treatment for 8 weeks versus 24 weeks was compared using logistic regression with treatment group, baseline log10 HCV RNA level, HCV subgenotype (1a or non-1a), geographic region (US or non-US), Interleukin 28B genotype (CC or non-CC), ABT-450/ritonavir dose and population (treatment-naïve or null-responders) as predictors.||2.40|0.18|0.525
72545299|NCT01464827|144619773|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.64||||0.375|TWO_SIDED|95.0|0.55|4.92||No adjustment for multiple comparison. Pre-specified 2-sided significance level of 0.05.|Regression, Logistic||Odds ratio: Groups \[F + G + K + L\] : Groups \[H + I + M + N\]|The percentage of participants with SVR24 after treatment for 12 weeks versus 24 weeks was compared using logistic regression with treatment group, baseline log10 HCV RNA level, HCV subgenotype (1a or non-1a), geographic region (US or non-US), Interleukin 28B genotype (CC or non-CC), ABT-450/ritonavir dose and population (treatment-naïve or null-responders) as predictors.||4.92|0.55|0.375
72545300|NCT01464827|144619774|SUPERIORITY_OR_OTHER||Difference|-12.16||||0.068|TWO_SIDED|95.0|-25.2|0.88||No adjustment for multiple comparison. Pre-specified 2-sided significance level of 0.05.|Mantel Haenszel|The Mantel-Haenszel method was used because logistic regression failed due to separation or quasi-separation.|Difference = Group B - Groups \[F + G + K + L\]|The percentage of participants with SVR24 after treatment with 2 DAAs and ribavirin versus 3 DAAs and ribavirin was compared using stratum-adjusted Mantel-Haenszel (MH) method with Interleukin 28B genotype (CC or non-CC) and HCV subgenotype (1a or non-1a).||0.88|-25.20|0.068
72545301|NCT01464827|144619774|SUPERIORITY_OR_OTHER||Difference|-6.75||||0.065|TWO_SIDED|95.0|-13.93|0.43||No adjustment for multiple comparison. Pre-specified 2-sided significance level of 0.05.|Mantel Haenszel|The Mantel-Haenszel method was used because logistic regression failed due to separation or quasi-separation.|Difference = Groups \[C + D + J\] - Groups \[F + G + K + L\]|The percentage of participants with SVR24 after treatment with 2 DAAs and ribavirin versus 3 DAAs and ribavirin was compared using stratum-adjusted Mantel-Haenszel (MH) method with Interleukin 28B genotype (CC or non-CC) and HCV subgenotype (1a or non-1a).||0.43|-13.93|0.065
72579828|NCT05736861|144689015|SUPERIORITY||Hazard Ratio (HR)|1.1|||||TWO_SIDED|95.0|0.4|2.6|||||The interval is a highest-density credible interval. Descriptive analysis is a maximum partial likelihood proportional hazards regression model. Low event rate precluded covariate adjustment.|||2.6|0.4|
72545302|NCT01464827|144619775|SUPERIORITY_OR_OTHER||Difference|-7.13||||0.106|TWO_SIDED|95.0|-15.77|1.51||No adjustment for multiple comparison. Pre-specified 2-sided significance level of 0.05.|Mantel Haenszel|The Mantel-Haenszel method was used because logistic regression failed due to separation or quasi-separation.|Difference = Group E - Groups \[F + G + K + L\]|The percentage of participants with SVR24 after treatment with 3 DAAs with and without ribavirin was compared using a stratum-adjusted Mantel-Haenszel (MH) method with Interleukin 28B genotype (CC or non-CC) and HCV subgenotype (1a or non-1a).||1.51|-15.77|0.106
72545303|NCT01464827|144619776|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.41||||0.616|TWO_SIDED|95.0|0.37|5.34||No adjustment for multiple comparison. Pre-specified 2-sided significance level of 0.05.|Regression, Logistic||Odds ratio: Groups \[F + G + H + I\] : Groups \[K + L + M + N\]|The percentage of participants with SVR24 after treatment with 3 DAAs and ribavirin in treatment-naïve versus null-responders was compared using logistic regression with treatment group, baseline log10 HCV RNA level, HCV subgenotype (1a or non-1a), geographic region (US or non-US), Interleukin 28B genotype (CC or non-CC), and ABT-450/ritonavir dose as predictors.||5.34|0.37|0.616
72579829|NCT05736861|144689018|SUPERIORITY|Statistical analysis was a Bayesian proportional hazards regression model with covariate adjustment and weakly informative priors.|Hazard Ratio (HR)|1.2|||||TWO_SIDED|95.0|0.6|1.8|||||The interval is a highest-density credible interval. Adjustment variables: randomization, age, sex, duration of symptoms prior to study drug, calendar time, vaccination status, geographic region, call center indicator, and baseline symptom severity.|||1.8|0.6|
72579830|NCT05736861|144689019|SUPERIORITY|Statistical analysis was a Bayesian cumulative probability ordinal regression model with covariate adjustment and weakly informative priors.|Odds Ratio (OR)|0.81|||||TWO_SIDED|95.0|0.5|1.13|||||The interval is a highest-density credible interval on the log relative odds scale. Odds ratio estimate from a Bayesian cumulative probability ordinal regression model with weakly informative priors.|||1.13|0.50|
72579831|NCT05736861|144689020|SUPERIORITY||Odds Ratio (OR)|0.76|||||TWO_SIDED|95.0|0.39|1.13|||||The interval is a highest-density credible interval on the log relative odds scale. Odds ratio estimate from a Bayesian cumulative probability ordinal regression model with weakly informative priors.|||1.13|0.39|
72579832|NCT05736861|144689021|SUPERIORITY||Odds Ratio (OR)|1.11|||||TWO_SIDED|95.0|0.52|1.91|||||||The interval is a highest-density credible interval on the log relative odds scale. Odds ratio estimate from a Bayesian cumulative probability ordinal regression model with weakly informative priors.|1.91|0.52|
72579833|NCT05736861|144689022|OTHER||Odds Ratio (OR)|1.01|||||TWO_SIDED|95.0|0.82|1.25|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 7||1.25|0.82|
72579834|NCT05736861|144689022|OTHER||Odds Ratio (OR)|0.98|||||TWO_SIDED|95.0|0.78|1.23|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 14||1.23|0.78|
72579835|NCT05736861|144689022|OTHER||Odds Ratio (OR)|1.07|||||TWO_SIDED|95.0|0.82|1.41|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 28||1.41|0.82|
72579836|NCT05736861|144689022|OTHER||Odds Ratio (OR)|0.76|||||TWO_SIDED|95.0|0.57|1.01|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 90||1.01|0.57|
72579837|NCT05736861|144689023|OTHER||Odds Ratio (OR)|1.1|||||TWO_SIDED|95.0|0.92|1.32|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 7||1.32|0.92|
72579838|NCT05736861|144689023|OTHER||Odds Ratio (OR)|1.01|||||TWO_SIDED|95.0|0.83|1.22|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 14||1.22|0.83|
72579839|NCT05736861|144689023|OTHER||Odds Ratio (OR)|1.01|||||TWO_SIDED|95.0|0.83|1.24|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 28||1.24|0.83|
72545304|NCT00981253|144619781|SUPERIORITY||Mean Difference (Final Values)|-10.1|||||TWO_SIDED|95.0|-18.7|-1.5|||ANCOVA|||||-1.5|-18.7|
72545305|NCT00981253|144619782|SUPERIORITY||||||<|0.05|||||||ANCOVA|||||||<0.05
72579840|NCT05736861|144689023|OTHER||Odds Ratio (OR)|0.89|||||TWO_SIDED|95.0|0.72|1.1||||||Day 90|Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|1.10|0.72|
72545306|NCT00981253|144619783|SUPERIORITY||Cox Proportional Hazard|0.47|||||TWO_SIDED|95.0|0.24|0.91|||Log Rank|||||0.91|0.24|
72545307|NCT00981253|144619784|SUPERIORITY||Mean Difference (Final Values)|0.5||||0.95|TWO_SIDED|95.0|-0.14|1.17|||ANCOVA|||||1.17|-0.14|.95
72579841|NCT05736861|144689024|OTHER||Odds Ratio (OR)|0.98|||||TWO_SIDED|95.0|0.8|1.2|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 7||1.20|0.80|
72579842|NCT05736861|144689024|OTHER||Odds Ratio (OR)|0.99|||||TWO_SIDED|95.0|0.78|1.25|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 14||1.25|0.78|
72579843|NCT05736861|144689024|OTHER||Odds Ratio (OR)|1.11|||||TWO_SIDED|95.0|0.86|1.43|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 28||1.43|0.86|
72411639|NCT00406029|144331704|SUPERIORITY_OR_OTHER||Difference in LS Means|0.8||||0.151|TWO_SIDED|95.0|-0.3|1.8|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.8|-0.3|0.151
72545308|NCT00981253|144619785|SUPERIORITY||Mean Difference (Final Values)|0.12||||0.99|TWO_SIDED|95.0|-0.22|0.46|||ANCOVA|||||0.46|-0.22|0.99
72545309|NCT00981253|144619786|SUPERIORITY||Mean Difference (Final Values)|0.46||||0.99|TWO_SIDED|95.0|-0.78|1.74|||ANCOVA|||||1.74|-0.78|0.99
72545310|NCT00981253|144619787|SUPERIORITY||Mean Difference (Final Values)|0.12||||0.99|TWO_SIDED|95.0|-0.22|0.46|||ANCOVA|||||0.46|-0.22|0.99
72545311|NCT00981253|144619787|SUPERIORITY||Mean Difference (Final Values)|0.13||||0.99|TWO_SIDED|95.0|-0.14|0.39|||ANCOVA|||||0.39|-0.14|0.99
72579844|NCT05736861|144689024|OTHER||Odds Ratio (OR)|0.86|||||TWO_SIDED|95.0|0.66|1.12|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 90||1.12|0.66|
72579845|NCT05736861|144689025|OTHER||Odds Ratio (OR)|1.08|||||TWO_SIDED|95.0|0.87|1.35|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 7||1.35|0.87|
72579846|NCT05736861|144689025|OTHER||Odds Ratio (OR)|1.23|||||TWO_SIDED|95.0|0.96|1.57|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 14||1.57|0.96|
72579847|NCT05736861|144689025|OTHER||Odds Ratio (OR)|1.19|||||TWO_SIDED|95.0|0.92|1.54|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 28||1.54|0.92|
72579848|NCT05736861|144689025|OTHER||Odds Ratio (OR)|0.91|||||TWO_SIDED|95.0|0.71|1.18|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 90||1.18|0.71|
72545312|NCT03882047|144619788|OTHER||||||<|0.01|||||||ANOVA|||||||<0.01
72579849|NCT05736861|144689026|OTHER||Odds Ratio (OR)|1.19|||||TWO_SIDED|95.0|0.97|1.47|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 7||1.47|0.97|
72411640|NCT00406029|144331704|SUPERIORITY_OR_OTHER||Difference in LS Means|0.0||||0.93|TWO_SIDED|95.0|-1.1|1.0|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.0|-1.1|0.930
72545313|NCT03882047|144619788|OTHER||||||<|0.01|||||||ANOVA|||||||<0.01
72545314|NCT03882047|144619788|OTHER|||||||0.03|||||||ANOVA|||||||0.03
72545315|NCT03882047|144619789|OTHER||||||<|0.01|||||||ANOVA|||||||<0.01
72545316|NCT03882047|144619789|OTHER||||||<|0.01|||||||ANOVA|||||||<0.01
72411641|NCT00406029|144331704|SUPERIORITY_OR_OTHER||Difference in LS Means|0.5||||0.343|TWO_SIDED|95.0|-0.6|1.6|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.6|-0.6|0.343
72545317|NCT03882047|144619789|OTHER|||||||0.31|||||||ANOVA|||||||0.31
72545318|NCT03882047|144619790|OTHER||||||<|0.01|||||||ANOVA|||||||<0.01
72545319|NCT03882047|144619790|OTHER||||||<|0.01|||||||ANOVA|||||||<0.01
72545320|NCT03882047|144619790|OTHER|||||||0.01|||||||ANOVA|||||||0.01
72545321|NCT03882047|144619791|OTHER|||||||0.08|||||||ANOVA|||||||0.08
72545322|NCT03882047|144619791|OTHER||||||<|0.01|||||||ANOVA|||||||<0.01
72545323|NCT03882047|144619791|OTHER|||||||0.1|||||||ANOVA|||||||0.10
72545324|NCT03882047|144619792|OTHER||||||<|0.01|||||||ANOVA|||||||<0.01
72545325|NCT03882047|144619792|OTHER||||||<|0.01|||||||ANOVA|||||||<0.01
72545326|NCT03882047|144619792|OTHER|||||||0.01|||||||ANOVA|||||||0.01
72545327|NCT03882047|144619793|OTHER|||||||0.02|||||||ANOVA|||||||0.02
72545328|NCT03882047|144619793|OTHER||||||<|0.01|||||||ANOVA|||||||<0.01
72545329|NCT03882047|144619793|OTHER|||||||0.05|||||||ANOVA|||||||0.05
72545330|NCT03882047|144619794|OTHER||||||<|0.01|||||||ANOVA|||||||<0.01
72545331|NCT03882047|144619794|OTHER||||||<|0.01|||||||ANOVA|||||||<0.01
72545332|NCT03882047|144619794|OTHER|||||||0.06|||||||ANOVA|||||||0.06
72545333|NCT03882047|144619795|OTHER||||||<|0.01|||||||ANOVA|||||||<0.01
72545334|NCT03882047|144619795|OTHER||||||<|0.01|||||||ANOVA|||||||<0.01
72545335|NCT03882047|144619795|OTHER|||||||0.46|||||||ANOVA|||||||0.46
72545336|NCT03882047|144619796|OTHER||||||<|0.01|||||||ANOVA|||||||<0.01
72545337|NCT03882047|144619796|OTHER||||||<|0.01|||||||ANOVA|||||||<0.01
72545338|NCT03882047|144619796|OTHER|||||||0.07|||||||ANOVA|||||||0.07
72545339|NCT03882047|144619797|OTHER||||||<|0.01|||||||ANOVA|||||||<0.01
72545340|NCT03882047|144619797|OTHER||||||<|0.01|||||||ANOVA|||||||<0.01
72545341|NCT03882047|144619797|OTHER|||||||0.53|||||||ANOVA|||||||0.53
72545342|NCT03882047|144619798|OTHER||||||<|0.01|||||||ANOVA|||||||<0.01
72579850|NCT05736861|144689026|OTHER||Odds Ratio (OR)|1.06|||||TWO_SIDED|95.0|0.84|1.33|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 14||1.33|0.84|
72579851|NCT05736861|144689026|OTHER||Odds Ratio (OR)|1.21|||||TWO_SIDED|95.0|0.95|1.55|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 28||1.55|0.95|
72545343|NCT03882047|144619798|OTHER||||||<|0.01|||||||ANOVA|||||||<0.01
72545344|NCT03882047|144619798|OTHER|||||||0.12|||||||ANOVA|||||||0.12
72411642|NCT00406029|144331704|SUPERIORITY_OR_OTHER||Difference in LS Means|0.2||||0.746|TWO_SIDED|95.0|-0.9|1.2|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.2|-0.9|0.746
72411643|NCT00406029|144331704|SUPERIORITY_OR_OTHER||Difference in LS Means|0.8||||0.222|TWO_SIDED|94.0|-0.5|2.0|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.||2.0|-0.5|0.222
72411644|NCT00406029|144331704|SUPERIORITY_OR_OTHER||Difference in LS Means|0.3||||0.673|TWO_SIDED|95.0|-1.0|1.5|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.5|-1.0|0.673
72545345|NCT01945138|144619847|SUPERIORITY_OR_OTHER|||||||0.003|TWO_SIDED||||||t-test, 2 sided|||||||0.003
72545346|NCT01945138|144619848|SUPERIORITY_OR_OTHER|||||||0.115|TWO_SIDED||||||t-test, 2 sided|||||||0.115
72545347|NCT01945138|144619849|SUPERIORITY_OR_OTHER|||||||0.193|TWO_SIDED||||||t-test, 2 sided|||||||0.193
72545348|NCT01945138|144619850|SUPERIORITY_OR_OTHER|||||||0.848|TWO_SIDED||||||t-test, 2 sided|||||||0.848
72545349|NCT01945138|144619851|SUPERIORITY_OR_OTHER|||||||0.074|TWO_SIDED||||||t-test, 2 sided|||||||0.074
72545350|NCT01945138|144619852|SUPERIORITY_OR_OTHER|||||||0.38|TWO_SIDED||||||t-test, 2 sided|||||||0.38
72545351|NCT01945138|144619853|SUPERIORITY_OR_OTHER|||||||0.461|TWO_SIDED||||||t-test, 2 sided|||||||0.461
72545352|NCT01945138|144619854|SUPERIORITY_OR_OTHER|||||||0.205|TWO_SIDED||||||t-test, 2 sided|||||||0.205
72545353|NCT01945138|144619855|SUPERIORITY_OR_OTHER|||||||0.157|TWO_SIDED||||||t-test, 2 sided|||||||0.157
72545354|NCT01945138|144619856|SUPERIORITY_OR_OTHER|||||||0.443|TWO_SIDED||||||t-test, 2 sided|||||||0.443
72545355|NCT01945138|144619857|SUPERIORITY_OR_OTHER|||||||0.04|TWO_SIDED||||||t-test, 2 sided|||||||0.04
72545356|NCT01945138|144619858|SUPERIORITY_OR_OTHER|||||||0.401|TWO_SIDED||||||t-test, 2 sided|||||||0.401
72545357|NCT01945138|144619859|SUPERIORITY_OR_OTHER|||||||0.22|TWO_SIDED||||||t-test, 2 sided|||||||0.22
72545358|NCT01945138|144619860|SUPERIORITY_OR_OTHER|||||||0.325|TWO_SIDED||||||t-test, 2 sided|||||||0.325
72545359|NCT01945138|144619861|SUPERIORITY_OR_OTHER|||||||0.311|TWO_SIDED||||||t-test, 2 sided|||||||0.311
72545360|NCT00358826|144619867|SUPERIORITY_OR_OTHER||||||<|0.001||||||Adjusted using Dunnett's method.|ANCOVA|The model included treatment effect, with baseline value as a covariate.||||||<0.001
72545361|NCT00358826|144619867|SUPERIORITY_OR_OTHER||||||<|0.001||||||Adjusted using Dunnett's method.|ANCOVA|The model included treatment effect, with baseline value as a covariate.||||||<0.001
72545362|NCT00358826|144619867|SUPERIORITY_OR_OTHER||||||<|0.001||||||Adjusted using Dunnett's method.|ANCOVA|The model included treatment effect, with baseline value as a covariate.||||||<0.001
72545363|NCT00358826|144619868|SUPERIORITY_OR_OTHER||||||<|0.001||||||Adjusted using Dunnett's method.|ANCOVA|The model included treatment effect, with baseline value as a covariate.||||||<0.001
72545364|NCT00358826|144619868|SUPERIORITY_OR_OTHER||||||<|0.001||||||Adjusted using Dunnett's method.|ANCOVA|The model included treatment effect, with baseline value as a covariate.||||||<0.001
72545365|NCT00358826|144619868|SUPERIORITY_OR_OTHER||||||<|0.001||||||Adjusted using Dunnett's method.|ANCOVA|The model included treatment effect, with baseline value as a covariate.||||||<0.001
72545366|NCT00358826|144619869|SUPERIORITY_OR_OTHER|||||||0.656||||||Adjusted using Dunnett's method.|ANCOVA|||||||0.656
72545367|NCT00358826|144619869|SUPERIORITY_OR_OTHER|||||||0.863||||||Adjusted using Dunnett's method.|ANCOVA|||||||0.863
72545368|NCT00358826|144619869|SUPERIORITY_OR_OTHER|||||||0.996||||||Adjusted using Dunnett's method.|ANCOVA|||||||0.996
72545369|NCT00358826|144619870|SUPERIORITY_OR_OTHER|||||||0.331||||||Adjusted using Dunnett's method.|ANCOVA|||||||0.331
72545370|NCT00358826|144619870|SUPERIORITY_OR_OTHER|||||||0.606||||||Adjusted using Dunnett's method.|ANCOVA|||||||0.606
72545371|NCT00358826|144619870|SUPERIORITY_OR_OTHER||||||<|0.001||||||Adjusted using Dunnett's method.|ANOVA|||||||<0.001
72545372|NCT00358826|144619871|SUPERIORITY_OR_OTHER|||||||0.22||||||Dunnett test compared with Placebo|ANCOVA|||||||0.22
72545373|NCT00358826|144619871|SUPERIORITY_OR_OTHER||||||<|0.005||||||Dunnett test compared with Placebo|ANCOVA|||||||<0.005
72545374|NCT00358826|144619871|SUPERIORITY_OR_OTHER|||||||0.6||||||Dunnett test compared with Placebo|ANCOVA|||||||0.60
72545375|NCT00358826|144619872|SUPERIORITY_OR_OTHER|||||||0.92||||||Dunnett test compared with Placebo|ANCOVA|||||||0.92
72545376|NCT00358826|144619872|SUPERIORITY_OR_OTHER|||||||0.96||||||Dunnett test compared with Placebo|ANCOVA|||||||0.96
72545377|NCT00358826|144619872|SUPERIORITY_OR_OTHER|||||||1||||||Dunnett test compared with Placebo|ANCOVA|||||||1.00
72545378|NCT00358826|144619873|SUPERIORITY_OR_OTHER|||||||0.99||||||Dunnett test compared with Placebo|ANCOVA|||||||0.99
72545379|NCT00358826|144619873|SUPERIORITY_OR_OTHER|||||||0.11||||||Dunnett test compared with Placebo|ANCOVA|||||||0.11
72545380|NCT00358826|144619873|SUPERIORITY_OR_OTHER|||||||0.99||||||Dunnett test compared with Placebo|ANCOVA|||||||0.99
72545381|NCT01716754|144619878|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.79||||0.576|TWO_SIDED|95.0|0.35|1.78|||Regression, Logistic|||||1.78|0.35|0.576
72545382|NCT01716754|144619878|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.84||||0.556|TWO_SIDED|95.0|0.46|1.52|||Regression, Logistic|||||1.52|0.46|0.556
72545383|NCT01716754|144619880|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.32||||0.483|TWO_SIDED|95.0|0.61|2.86|||Regression, Logistic|||||2.86|0.61|0.483
72545384|NCT01716754|144619880|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.39||||0.261|TWO_SIDED|95.0|0.79|2.44|||Regression, Logistic|||||2.44|0.79|0.261
72545385|NCT01716754|144619882|SUPERIORITY_OR_OTHER|||||||0.604|||||||Repeated measures mixed model|||Morning||||0.604
72545386|NCT01716754|144619882|SUPERIORITY_OR_OTHER|||||||0.26|||||||Repeated measures mixed model|||Morning||||0.260
72545387|NCT01716754|144619882|SUPERIORITY_OR_OTHER|||||||0.937|||||||Repeated measures mixed model|||Evening||||0.937
72545388|NCT01716754|144619882|SUPERIORITY_OR_OTHER|||||||0.88|||||||Repeated measures mixed model|||Evening||||0.880
72545389|NCT01716754|144619882|SUPERIORITY_OR_OTHER|||||||0.762|||||||Repeated measures mixed model|||Overall daily||||0.762
72545390|NCT01716754|144619882|SUPERIORITY_OR_OTHER|||||||0.408|||||||Repeated measures mixed model|||Overall daily||||0.408
72545391|NCT00481247|144619883|SUPERIORITY_OR_OTHER|||||||0.0056||||||A priori threshold for statistical significance=0.05.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by Hasford Score.||||||0.0056
72545392|NCT00481247|144619884|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.79|||||TWO_SIDED|95.0|0.55|1.13||||||||1.13|0.55|
72545393|NCT00481247|144619886|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.46|||||TWO_SIDED|95.0|1.2|1.77||||||Hazard Ratio and Confidence Interval were based on analyses on all randomized subjects||1.77|1.20|
72545394|NCT00481247|144619887|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.54|||||TWO_SIDED|95.0|1.25|1.89||||||Hazard Ratio, and Confidence Interval were based on analyses on all randomized subjects||1.89|1.25|
72545395|NCT01620489|144619902|SUPERIORITY_OR_OTHER||Estimated treatment difference|-0.66|||<|0.0001||95.0|-0.9|-0.43||Adjustment for multiple comparisons was not used since there was only one primary endpoint.|Mixed Models Analysis|||The null hypothesis of no treatment difference was tested using a two-sided test based on a mixed model repeated measurement (MMRM) analysis. The model included treatment, country, stratification groups (6 groups from cross-classifying renal function category (2 levels: eGFR\<45 and ≥45 mL/min) and the background insulin treatment category (3 levels: basal, premix or no insulin)) as fixed effects factors and baseline HbA1c as a covariate, all nested within week.||-0.43|-0.90|<0.0001
72545396|NCT01620489|144619903|SUPERIORITY_OR_OTHER||Estimated odds ratio|4.48|||<|0.0001||95.0|2.46|8.18||Not adjusted for multiple comparisons|Regression, Logistic|||Analysed by a logistic regression model with treatment, country and stratification groups as fixed effects and HbA1c and body weight at baseline as covariates. No weight gain was defined as change from baseline to Week 26 in body weight ≤0 kg.||8.18|2.46|<0.0001
72545397|NCT01620489|144619904|SUPERIORITY_OR_OTHER||Estimated odds ratio|3.94|||<|0.0001||95.0|2.12|7.3||Not adjusted for multiple comparisons|Regression, Logistic|||Analysed by a logistic regression model with treatment, country and stratification groups as fixed effects and HbA1c at baseline as covariates.||7.30|2.12|<0.0001
72545398|NCT01620489|144619905|SUPERIORITY_OR_OTHER||Estimated treatment difference|-1.08|||<|0.0001||95.0|-1.58|-0.58||Not adjusted for multiple comparisons|Mixed Models Analysis|||Mean change from baseline in the 7-point profile (SMPG) after 26 weeks treatment was analysed using an MMRM model with treatment, country and stratification groups as fixed effects and baseline as a covariate, all nested within visit.||-0.58|-1.58|<0.0001
72545399|NCT01620489|144619906|SUPERIORITY_OR_OTHER||Estimated treatment difference|-0.51|||=|0.0022||95.0|-0.83|-0.18|||Mixed Models Analysis|Not adjusted for multiple comparisons||Change from baseline in BMI (kg/m˄2) after 26 weeks treatment was analysed separately using an MMRM analysis model with treatment, country and stratification groups as fixed effects and baseline as a covariate, all nested within visit.||-0.18|-0.83|= 0.0022
72545400|NCT01620489|144619907|SUPERIORITY_OR_OTHER||Estimated treatment ratio|0.98|||=|0.3575||95.0|0.94|1.02||Not adjusted for multiple comparisons|Mixed Models Analysis|||The ratio to baseline in eGFR (mL/min/1.73m˄2) after 26 weeks treatment was estimated based on log-transformed data for changes from baseline. The responses were analysed using an MMRM model with treatment, country and stratification groups as fixed effects and log-transformed baseline as a covariate, all nested within visit. The resulting estimates were back-transformed to the original scale.||1.02|0.94|= 0.3575
72545401|NCT00321711|144619908|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.032||||||95.0|0.153|6.95||||||||6.950|0.153|
72545402|NCT00321711|144619908|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.333||||||95.0|0.028|3.926||||||||3.926|0.028|
72545403|NCT00321711|144619908|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.118||||||95.0|0.007|1.882|||||Adjusted by the stratification factor|||1.882|0.007|
72545404|NCT00321711|144619909|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.0||||||95.0|0.063|15.988|||||Romiplostim/placebo|||15.988|0.063|
72579852|NCT05736861|144689026|OTHER||Odds Ratio (OR)|0.93|||||TWO_SIDED|95.0|0.73|1.19|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 90||1.19|0.73|
72545405|NCT00321711|144619910|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.827||||||95.0|0.347|9.618|||||Romiplostim/placebo|||9.618|0.347|
72545406|NCT00321711|144619910|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.445||||||95.0|0.037|5.325|||||Romiplostim/placebo|||5.325|0.037|
72545407|NCT00321711|144619910|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.444||||||95.0|0.032|6.08|||||Romiplostim/placebo|||6.080|0.032|
72545408|NCT00321711|144619911|SUPERIORITY_OR_OTHER||Difference in incidence rate|-33.5||||||95.0|-69.0|2.0|||||Romiplostim - placebo|||2.0|-69.0|
72579853|NCT05736861|144689027|OTHER||Odds Ratio (OR)|1.05|||||TWO_SIDED|95.0|0.86|1.26|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 7||1.26|0.86|
72545409|NCT00321711|144619911|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.315||||||95.0|0.029|3.412||||||||3.412|0.029|
72545410|NCT00321711|144619911|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.211||||||95.0|0.021|2.082||||||||2.082|0.021|
72545411|NCT01484028|144619913|NON_INFERIORITY_OR_EQUIVALENCE|A non-inferiority margin of 0.05 LogMAR was used.|Least-square mean difference|0.011|STANDARD_ERROR_OF_MEAN|0.0034|||TWO_SIDED|95.0|0.004|0.017|||Mixed Models Analysis|||The alternative hypothesis is the monocular distance Snellen VA (LogMAR scale) of etafilcon A with embedded print and PVP for dark/light eyes is non-inferior to that of etafilcon A control lenses.||0.017|0.004|
72545412|NCT01360450|144619922|OTHER||Mean Difference (Final Values)|0.05|||>|0.05|TWO_SIDED|||||yes the P value was adjusted for multiple comparisons.|ANOVA|2 sided ANOVA|Mean difference between the two treatment arms|||||>0.05
72545413|NCT01149616|144619935|SUPERIORITY|||||||0.007|||||||ANOVA|||||||0.007
72545414|NCT01149616|144619936|SUPERIORITY|||||||0.006|||||||ANOVA|||||||0.006
72545415|NCT01149616|144619937|SUPERIORITY|||||||0.05||||||P value was calculated, and threshold for significance calculated at less than or equal to 0.05|ANOVA|||||||0.05
72545416|NCT01512979|144619942|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.79|STANDARD_ERROR_OF_MEAN|0.17|<|0.0001||95.0|-1.13|-0.46||The model includes treatment and continuous baseline HbA1c.|ANCOVA|||||-0.46|-1.13|<0.0001
72545417|NCT01512979|144619943|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.9|STANDARD_ERROR_OF_MEAN|5.7||0.0032||95.0|-28.0|-5.7||The model includes treatment, continuous baseline HbA1c and continuous baseline FPG.|ANCOVA|||||-5.7|-28.0|0.0032
72545418|NCT01512979|144619945|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.83||||0.0031||95.0|1.573|9.328||The model includes treatment and continuous baseline HbA1c.|Regression, Logistic|||||9.328|1.573|0.0031
72545419|NCT01512979|144619946|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.92||||0.0025||95.0|1.458|5.849||The model includes treatment and continuous baseline HbA1c.|Regression, Logistic|||||5.849|1.458|0.0025
72545420|NCT01512979|144619947|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.448||||0.0008||95.0|1.453|4.123||The model includes treatment and continuous baseline HbA1c.|Regression, Logistic|||||4.123|1.453|0.0008
72545421|NCT00526890|144619966|OTHER|||||||0.3149|||||||Wilcoxon (Mann-Whitney)|||Mann-Whitney-Wilcoxon test was used to test the correlation between selenium levels and serious adverse events.||||0.3149
72579854|NCT05736861|144689027|OTHER||Odds Ratio (OR)|1.05|||||TWO_SIDED|95.0|0.85|1.29|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 14||1.29|0.85|
72579855|NCT05736861|144689027|OTHER||Odds Ratio (OR)|1.07|||||TWO_SIDED|95.0|0.85|1.34|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 28||1.34|0.85|
72579856|NCT05736861|144689027|OTHER||Odds Ratio (OR)|1.01|||||TWO_SIDED|95.0|0.8|1.28|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 90||1.28|0.80|
72545422|NCT03529955|144619972|EQUIVALENCE|The student t test (paired) and ANOVA analysis of variance were used to assess the mean change in CDASI, MMT-8, DLQI and to compare the positive cell detection on immunohistochemistry for CCL5, pSTAT1 and pSTAT3 at baseline and 3 months post apremilast. All p values were two-sided, and values \<0.05 were considered statistically significant. Analyses were performed using GraphPad Prism 8 (GraphPad Software Inc.). The last observation carried forward approach was used for missing values.||||||0.01||||||The investigators hypothesized that genes identified as significantly differentially expressed between the two groups will have ≥2-fold change at p\<0.01.|ANOVA|||The student t test (paired) and ANOVA analysis of variance were used to assess the mean change in CDASI, MMT-8, DLQI and to compare the positive cell detection on immunohistochemistry for CCL5, pSTAT1 and pSTAT3 at baseline and 3 months post apremilast. All p values were two-sided, and values \<0.05 were considered statistically significant. Analyses were performed using GraphPad Prism 8 (GraphPad Software Inc.). The last observation carried forward approach was used for missing values.||||0.01
72579857|NCT05736861|144689028|OTHER||Odds Ratio (OR)|1.05|||||TWO_SIDED|95.0|0.88|1.27|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 7||1.27|0.88|
72579858|NCT05736861|144689028|OTHER||Odds Ratio (OR)|0.95|||||TWO_SIDED|95.0|0.79|1.14|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 14||1.14|0.79|
72579859|NCT05736861|144689028|OTHER||Odds Ratio (OR)|0.9|||||TWO_SIDED|95.0|0.75|1.09|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 28||1.09|0.75|
72579860|NCT05736861|144689028|OTHER||Odds Ratio (OR)|1.13|||||TWO_SIDED|95.0|0.93|1.36|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 90||1.36|0.93|
72579861|NCT05736861|144689029|SUPERIORITY||Difference in model estimate time unwell|-0.49|||||TWO_SIDED|95.0|-0.82|-0.15|||||The interval is a highest-density credible interval.|||-0.15|-0.82|
72579862|NCT05736861|144689030|SUPERIORITY||Difference in model estimated means|0.59|||||TWO_SIDED|95.0|0.18|0.99|||||The interval is a highest-density credible interval.|Analysis is exploratory. No hypothesis test or decision rule was evaluated.||0.99|0.18|
72579863|NCT00879255|144689031|NON_INFERIORITY_OR_EQUIVALENCE|We used a noninferiority design to test the hypothesis that VTC is noninferior to in-person treatment delivery. The noninferiority margin was determined to be 10 CAPS points. We analyzed means differences in CAPS scores between the two treatment conditions (VTC minus in-person) with positive values indicating greater reductions in VTC condition. Power was estimated to be 90% with alpha = .20, and a between-group difference equaling an effect size of d = .50 (estimated 10 CAPS points).|Mean Difference (Final Values)|-4.75|||>|0.05|TWO_SIDED|95.0|-11.92|2.42||"The noninferiority margin is the maximum clinically meaningful amount by which VTC can be worse than the in-person delivery to allow for a conclusion of noninferiority (a priori set to 10 CAPS points)."|noninferiority analysis|We hypothesized that VTC is noninferior to in-person condition, which is supported if upper limit of 95% CI is less than preset noninferiority margin.|The noninferiority hypothesis would be supported if the 95% Confidence Interval of the difference in CAPS scores between the 2 conditions (VTC minus in-person scores) is less than the present noninferiority margin (10 CAPS points).|||2.42|-11.92|> .05
72579864|NCT00879255|144689032|NON_INFERIORITY_OR_EQUIVALENCE|We used a noninferiority design to test the hypothesis that VTC is noninferior to in-person treatment delivery. The noninferiority margin was determined to be 10 CAPS points. We analyzed means differences in CAPS scores between the two treatment conditions (VTC minus in-person) with positive values indicating greater reductions in VTC condition. Power was estimated to be 90% with alpha = .20, and a between-group difference equaling an effect size of d = .50 (estimated 10 CAPS points).|Mean Difference (Final Values)|-4.76|||>|0.05|TWO_SIDED|95.0|-11.65|2.13||"The noninferiority margin is the maximum clinically meaningful amount by which VTC can be worse than the in-person delivery to allow for a conclusion of noninferiority (a priori set to 10 CAPS points)."|noninferiority design|We hypothesized that VTC is noninferior to in-person condition, which is supported if upper limit of 95% CI is less than preset noninferiority margin.|The noninferiority hypothesis would be supported if the 95% Confidence Interval of the difference in CAPS scores between the 2 conditions (VTC minus in-person scores) is less than the present noninferiority margin (10 CAPS points).|||2.13|-11.65|> .05
72545423|NCT03740100|144619976|OTHER||Percent with objective response|17.0|||||TWO_SIDED|95.0|1.0|58.0||||||The primary endpoint was to determine the objective response rate of patients with R/M HNSCC harboring NOTCH1 LOF mutations to oral bimiralisib using RECIST v1.1. We used a Simon's optimal two-stage design. In order to have 80% power to detect a response rate of 30%, (one-sided α=0.05 and β=0.20), we planned to enroll up to 10 patients in the first stage. If ≥ 2 patients had an objective response, then the study would enroll an additional 19 patients in the second stage.||58|1|
72545424|NCT04192799|144619983|EQUIVALENCE|Testing was two-sided and p-values \<0.05 were considered statistically significant.|Mean Ratio|0.74|||<|0.001|TWO_SIDED|95.0|0.65|0.85||Testing was two-sided and p-values \<0.05 were considered statistically significant, not adjusted for multiple comparison.|Gamma Regression with Log Link Function|Adjusted for demographics, clinical characteristics, time period; interaction term for hospital and time period, random effect for practice group.||||0.85|0.65|<0.001
72545425|NCT04192799|144619984|EQUIVALENCE|Testing was two-sided and p-values \<0.05 were considered statistically significant.|Mean Ratio|1.12|||<|0.001|TWO_SIDED|95.0|1.06|1.19||Testing was two-sided and p-values \<0.05 were considered statistically significant, not adjusted for multiple comparison.|Gamma Regression with Log Link Function|Adjusted for demographics, clinical characteristics, time period; interaction term for hospital and time period, random effect for practice group.||||1.19|1.06|<0.001
72545426|NCT04192799|144619985|EQUIVALENCE|Testing was two-sided and p-values \<0.05 were considered statistically significant.|Mean Ratio|0.93||||0.37|TWO_SIDED|95.0|0.8|1.09||Testing was two-sided and p-values \<0.05 were considered statistically significant, not adjusted for multiple comparison.|Gamma Regression with Log Link Function|Adjusted for demographics, clinical characteristics, time period; interaction term for hospital and time period, random effect for practice group.||||1.09|0.80|0.37
72545427|NCT04192799|144619986|EQUIVALENCE|Testing was two-sided and p-values \<0.05 were considered statistically significant.|Odds Ratio (OR)|1.31||||0.81|TWO_SIDED|95.0|0.14|12.27||Testing was two-sided and p-values \<0.05 were considered statistically significant, not adjusted for multiple comparison.|Regression, Logistic|Adjusted for demographics, clinical characteristics, time period; interaction term for hospital and time period, random effect for practice group.||||12.27|0.14|0.81
72545428|NCT04192799|144619987|EQUIVALENCE|Testing was two-sided and p-values \<0.05 were considered statistically significant.|Slope|0.05||||0.12|TWO_SIDED|95.0|-0.01|0.11|||Regression, Linear|Adjusted for demographics, clinical characteristics, time period; interaction term for hospital and time period, random effect for practice group.||||0.11|-0.01|0.12
72545429|NCT02004847|144619988|SUPERIORITY_OR_OTHER|||||||0.0005|TWO_SIDED||||||t-test, 2 sided|||Statistically analysed were the difference in change from baseline to the end of treatment (week 12) of the target plaque compared to the control plaque.||||0.0005
72579865|NCT00879255|144689033|NON_INFERIORITY_OR_EQUIVALENCE|We used a noninferiority design to test the hypothesis that VTC is noninferior to in-person treatment delivery. The noninferiority margin was determined to be 10 CAPS points. We analyzed means differences in CAPS scores between the two treatment conditions (VTC minus in-person) with positive values indicating greater reductions in VTC condition. Power was estimated to be 90% with alpha = .20, and a between-group difference equaling an effect size of d = .50 (estimated 10 CAPS points).|Mean Difference (Final Values)|-5.56|||>|0.05|TWO_SIDED|95.0|-16.26|5.14||"The noninferiority margin is the maximum clinically meaningful amount by which VTC can be worse than the in-person delivery to allow for a conclusion of noninferiority (a priori set to 10 CAPS points)."|noninferiority test|We hypothesized that VTC is noninferior to in-person condition, which is supported if upper limit of 95% CI is less than preset noninferiority margin.|The noninferiority hypothesis would be supported if the 95% Confidence Interval of the difference in CAPS scores between the 2 conditions (VTC minus in-person scores) is less than the present noninferiority margin (10 CAPS points).|||5.14|-16.26|> .05
72579866|NCT01130532|144689058|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Fisher Exact|||||||<0.001
72579867|NCT01130532|144689058|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Fisher Exact|||||||<0.001
72579868|NCT01130532|144689059|SUPERIORITY_OR_OTHER||LS Mean Difference|6.1|STANDARD_ERROR_OF_MEAN|0.69|<|0.001||95.0||||Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|ANCOVA|||||||<0.001
72579869|NCT01130532|144689059|SUPERIORITY_OR_OTHER||LS Mean Difference|6.2|STANDARD_ERROR_OF_MEAN|0.68|<|0.001||95.0||||Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|ANCOVA|||||||<0.001
72579870|NCT01130532|144689060|SUPERIORITY_OR_OTHER||LS Mean Difference|2.1|STANDARD_ERROR_OF_MEAN|0.29|<|0.001||95.0||||Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|ANCOVA|||||||<0.001
72579871|NCT01130532|144689060|SUPERIORITY_OR_OTHER||LS Mean Difference|2.0|STANDARD_ERROR_OF_MEAN|0.29|<|0.001||95.0||||Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|ANCOVA|||||||<0.001
72579872|NCT01130532|144689061|SUPERIORITY_OR_OTHER||LS Mean Difference|1.7|STANDARD_ERROR_OF_MEAN|0.23|<|0.001||95.0||||Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|ANCOVA|||||||<0.001
72579873|NCT01130532|144689061|SUPERIORITY_OR_OTHER||LS Mean Difference|1.7|STANDARD_ERROR_OF_MEAN|0.22|<|0.001||95.0||||Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|ANCOVA|||||||<0.001
72579874|NCT01130532|144689062|SUPERIORITY_OR_OTHER||LS Mean Difference|10.4|STANDARD_ERROR_OF_MEAN|2.28|<|0.001||95.0||||P-value is for Question 1. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|ANCOVA|||||||<0.001
72579875|NCT01130532|144689062|SUPERIORITY_OR_OTHER||LS Mean Difference|9.6|STANDARD_ERROR_OF_MEAN|2.26|<|0.001||95.0||||P-value is for Question 1. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|ANCOVA|||||||<0.001
72579876|NCT01130532|144689062|SUPERIORITY_OR_OTHER||LS Mean Difference|19.3|STANDARD_ERROR_OF_MEAN|3.14|<|0.001||95.0||||P-value is for Question 2. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|ANCOVA|||||||<0.001
72579877|NCT01130532|144689062|SUPERIORITY_OR_OTHER||LS Mean Difference|19.3|STANDARD_ERROR_OF_MEAN|3.12|<|0.001||95.0||||P-value is for Question 2. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|ANCOVA|||||||<0.001
72579878|NCT01130532|144689062|SUPERIORITY_OR_OTHER||LS Mean Difference|24.7|STANDARD_ERROR_OF_MEAN|3.53|<|0.001||95.0||||P-value is for Question 3. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|ANCOVA|||||||<0.001
72579879|NCT01130532|144689062|SUPERIORITY_OR_OTHER||LS Mean Difference|26.8|STANDARD_ERROR_OF_MEAN|3.5|<|0.001||95.0||||P-value is for Question 3. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|ANCOVA|||||||<0.001
72579880|NCT01130532|144689062|SUPERIORITY_OR_OTHER||LS Mean Difference|32.7|STANDARD_ERROR_OF_MEAN|3.82|<|0.001||95.0||||P-value is for Question 4. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|ANCOVA|||||||<0.001
72579881|NCT01130532|144689062|SUPERIORITY_OR_OTHER||LS Mean Difference|31.3|STANDARD_ERROR_OF_MEAN|3.79|<|0.001||95.0||||P-value is for Question 4. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|ANCOVA|||||||<0.001
72579882|NCT01130532|144689062|SUPERIORITY_OR_OTHER||LS Mean Difference|33.0|STANDARD_ERROR_OF_MEAN|3.78|<|0.001||95.0||||P-value is for Question 5. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|ANCOVA|||||||<0.001
72579883|NCT01130532|144689062|SUPERIORITY_OR_OTHER||LS Mean Difference|30.5|STANDARD_ERROR_OF_MEAN|3.75|<|0.001||95.0||||P-value is for Question 5. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|ANCOVA|||||||<0.001
72579884|NCT01130532|144689063|SUPERIORITY_OR_OTHER||LS Mean Difference|23.1|STANDARD_ERROR_OF_MEAN|2.49|<|0.001||95.0||||P-value is for confidence to complete sexual activity. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|ANCOVA|||||||<0.001
72411645|NCT00406029|144331704|SUPERIORITY_OR_OTHER||Difference in LS Means|0.5||||0.415|TWO_SIDED|95.0|-0.7|1.7|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.7|-0.7|0.415
72579885|NCT01130532|144689063|SUPERIORITY_OR_OTHER||LS Mean Difference|25.4|STANDARD_ERROR_OF_MEAN|2.48|<|0.001||95.0||||P-value is for confidence to complete sexual activity. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|ANCOVA|||||||<0.001
72411646|NCT00406029|144331704|SUPERIORITY_OR_OTHER||Difference in LS Means|0.0||||0.968|TWO_SIDED|95.0|-1.3|1.2|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.2|-1.3|0.968
72545430|NCT02004847|144619989|SUPERIORITY_OR_OTHER|||||||0.0036|TWO_SIDED||||||t-test, 2 sided|||Statistically analysed were the difference in change from baseline to the end of treatment during the attack period (week 4) of the target plaque compared to the control plaque.||||0.0036
72545431|NCT02004847|144619990|SUPERIORITY_OR_OTHER|||||||0.3075|TWO_SIDED||||||t-test, 2 sided|||Statistically analysed were the difference in change from end of treatment (week 12, visit 7) to end of follow up (week 16, visit 8) of the target plaque compared to the control plaque.||||0.3075
72545432|NCT02004847|144619991|SUPERIORITY_OR_OTHER|||||||0.014|TWO_SIDED||||||t-test, 2 sided|||Statistically analysed were the difference in change from baseline to week 4 of the target plaque compared to the control plaque.||||0.0140
72545433|NCT02004847|144619991|SUPERIORITY_OR_OTHER|||||||0.0064|TWO_SIDED||||||t-test, 2 sided|||Statistically analysed were the difference in change from baseline to week 12 of the target plaque compared to the control plaque.||||0.0064
72545434|NCT02004847|144619991|SUPERIORITY_OR_OTHER|||||||0.102|TWO_SIDED||||||t-test, 2 sided|||Statistically analysed were the difference in change from baseline to week 16 of the target plaque compared to the control plaque.||||0.1020
72545435|NCT05321810|144620009|OTHER|||||||0.016|||||||Log Rank|||Statistical analysis has been presented for all time points from 0 to 24 months.|\[Not specified\]|||0.016
72545436|NCT05321810|144620014|OTHER||Hazard Ratio (HR)|0.812||||0.013|TWO_SIDED|95.0|0.69|0.957|||t-test, 2 sided|||Statistical analysis has been presented for all time points from 0 to 24 months.|\[Not specified\]|0.957|0.690|0.013
72545437|NCT05321810|144620020|OTHER|||||||0.002|||||||Log Rank|||Statistical analysis has been presented for all time points from 0 to 24 months.|\[Not specified\]|||0.002
72545438|NCT05321810|144620023|OTHER||||||<|0.001|||||||Log Rank|||Statistical analysis has been presented for all time points from 0 to 24 months.|\[Not specified\]|||<0.001
72545439|NCT05321810|144620024|OTHER||Hazard Ratio (HR)|0.57|||<|0.001|TWO_SIDED|95.0|0.42|0.773|||t-test, 2 sided|||Statistical analysis has been presented for all time points from 0 to 24 months.|\[Not specified\]|0.773|0.420|<0.001
72545440|NCT05321810|144620026|OTHER|||||||0.35|||||||Log Rank|||Statistical analysis has been presented for all time points from 0 to 24 months.|\[Not specified\]|||0.350
72545441|NCT05321810|144620027|OTHER||Hazard Ratio (HR)|1.155||||0.324|TWO_SIDED|95.0|0.867|1.54|||t-test, 2 sided|||Statistical analysis has been presented for all time points from 0 to 24 months.|\[Not specified\]|1.540|0.867|0.324
72545442|NCT05321810|144620029|OTHER|||||||0.111|||||||Log Rank|||Statistical analysis has been presented for all time points from 0 to 24 months.|\[Not specified\]|||0.111
72545443|NCT05321810|144620030|OTHER||Hazard Ratio (HR)|0.866||||0.1|TWO_SIDED|95.0|0.73|1.028|||t-test, 2 sided|||Statistical analysis has been presented for all time points from 0 to 24 months.|\[Not specified\]|1.028|0.730|0.100
72545444|NCT05321810|144620032|OTHER|||||||0.979|||||||Log Rank|||Statistical analysis has been presented for all time points from 0 to 24 months.|\[Not specified\]|||0.979
72545445|NCT05321810|144620033|OTHER||Hazard Ratio (HR)|1.002||||0.978|TWO_SIDED|95.0|0.854|1.177|||t-test, 2 sided|||Statistical analysis has been presented for all time points from 0 to 24 months.|\[Not specified\]|1.177|0.854|0.978
72545446|NCT05321810|144620035|OTHER||||||<|0.001|||||||Log Rank|||Statistical analysis has been presented for all time points from 0 to 24 months.|\[Not specified\]|||<0.001
72545447|NCT05321810|144620036|OTHER||Hazard Ratio (HR)|0.428|||<|0.001|TWO_SIDED|95.0|0.263|0.697|||t-test, 2 sided|||Statistical analysis has been presented for all time points from 0 to 24 months.|\[Not specified\]|0.697|0.263|<0.001
72545448|NCT05321810|144620040|OTHER||Hazard Ratio (HR)|0.727||||0.001|TWO_SIDED|95.0|0.599|0.881|||t-test, 2 sided|||Statistical analysis has been presented for all time points from 0 to 24 months.|\[Not specified\]|0.881|0.599|0.001
72545449|NCT00803959|144620051|NON_INFERIORITY_OR_EQUIVALENCE|The investigators selected the 11% noninferiority margin on the basis of clinical judgement that it was a reasonable threshold for a trade-off between a decrease in the rate of successful treatment and the potential benefits of eliminating UDS studies from preoperative assessment. To minimize bias toward noninferiority, only women treated per protocol (e.g. who underwent the randomly assigned evaluation) were considered in the primary outcome analysis (ITT analysis considered secondary).|Difference in success % (UDS - no UDS)|-0.3|||||TWO_SIDED|95.0|-7.5|6.9|||Chi-squared|Noninferiority declared if the upper boundary of the two-sided 95% confidence interval for the difference in % success (UDS - no UDS) was \< 11%.|Point estimates of success percentage are calculated as 200/259= 77.2% for Office Evaluation Only and 203/264 = 76.9% for Urodynamic Testing arm.|The null hypothesis was that the no UDS group was non-inferior to those in the UDS group. Assuming a significance level of 5% and a true success rate in each group of 70% with a noninferiority margin of 11 percentage points, we needed to enroll 270 women/group to have 80% power for determining whether the results in the no UDS group were non inferior to those in the UDS group. Assuming a 10% dropout rate, a sample of 300 women per group was required.||6.9|-7.5|
72545450|NCT00803959|144620052|SUPERIORITY_OR_OTHER|||||||0.63||95.0||||The p-value is not adjusted for multiple comparisons. Alpha level is considered to be 0.05.|Chi-squared|No adjustments were made; test had 1 degree of freedom.||Null hypothesis is that the two groups will not differ in the percent meeting 70% reduction in Urogenital Distress Inventory score.||||0.63
72545451|NCT00803959|144620053|SUPERIORITY_OR_OTHER|||||||0.68||95.0||||P-value not adjusted for multiple comparisons; a priori threshold for statistical significance set at alpha = 0.05.|Chi-squared|No adjustments made; 1 degree of freedom test.||"Null hypothesis is that there is no difference in the proportion responding very much better or much better on the Patient Global Impression of Improvement at the 12 month visit."||||0.68
72545452|NCT00803959|144620054|SUPERIORITY_OR_OTHER|||||||0.68||95.0||||P-value is not adjusted for multiple comparisons; a priori threshold for statistical significance was set at alpha = 0.05.|t-test, 2 sided|One df t test assumed equal variance; no evidence was found to the contrary.||Null hypothesis is that the two arms do not differ according to change in UDI score.||||0.68
72545453|NCT00803959|144620055|SUPERIORITY_OR_OTHER|||||||0.4||95.0||||P-value was not adjusted for multiple comparisons; a priori threshold for statistical significance set at alpha = 0.05.|t-test, 2 sided|Test was 1 df t-test assuming equal variances; no evidence to the contrary was found.||Null hypothesis is that the 2 arms do not differ according to change in ISI score.||||0.40
72411647|NCT00406029|144331704|SUPERIORITY_OR_OTHER||Difference in LS Means|0.4||||0.543|TWO_SIDED|95.0|-1.0|1.9|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.9|-1.0|0.543
72411648|NCT00406029|144331704|SUPERIORITY_OR_OTHER||Difference in LS Means|0.0||||0.967|TWO_SIDED|95.0|-1.4|1.4|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.4|-1.4|0.967
72411649|NCT00406029|144331704|SUPERIORITY_OR_OTHER||Difference in LS Means|0.6||||0.411|TWO_SIDED|95.0|-0.8|2.0|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.||2.0|-0.8|0.411
72411650|NCT00406029|144331704|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.1||||0.864|TWO_SIDED|95.0|-1.6|1.3|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.3|-1.6|0.864
72411651|NCT00406029|144331704|SUPERIORITY_OR_OTHER||Difference in LS Means|0.6||||0.449|TWO_SIDED|95.0|-0.9|2.0|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.||2.0|-0.9|0.449
72579886|NCT01130532|144689063|SUPERIORITY_OR_OTHER||LS Mean Difference|19.9|STANDARD_ERROR_OF_MEAN|2.36|<|0.001||95.0||||P-value is for ease of erection. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|ANCOVA|||||||<0.001
72411652|NCT00406029|144331704|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.6||||0.411|TWO_SIDED|95.0|-2.0|0.8|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.8|-2.0|0.411
72411653|NCT00406029|144331704|SUPERIORITY_OR_OTHER||Difference in LS Means|0.4||||0.576|TWO_SIDED|95.0|-1.0|1.8|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.8|-1.0|0.576
72411654|NCT00406029|144331704|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.4||||0.603|TWO_SIDED|95.0|-1.9|1.1|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.1|-1.9|0.603
72411655|NCT00406029|144331704|SUPERIORITY_OR_OTHER||Difference in LS Means|0.2||||0.842|TWO_SIDED|95.0|-1.4|1.7|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.7|-1.4|0.842
72411656|NCT00406029|144331704|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.4||||0.558|TWO_SIDED|95.0|-1.9|1.0|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.0|-1.9|0.558
72411657|NCT00406029|144331704|SUPERIORITY_OR_OTHER||Difference in LS Means|0.9||||0.245|TWO_SIDED|95.0|-0.6|2.4|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.||2.4|-0.6|0.245
72579887|NCT01130532|144689063|SUPERIORITY_OR_OTHER||LS Mean Difference|20.6|STANDARD_ERROR_OF_MEAN|2.35|<|0.001||95.0||||P-value is for ease of erection. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|ANCOVA|||||||<0.001
72579888|NCT01130532|144689063|SUPERIORITY_OR_OTHER||LS Mean Difference|19.3|STANDARD_ERROR_OF_MEAN|2.21|<|0.001||95.0||||P-value is for pleasure from sexual activity. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|ANCOVA|||||||<0.001
72579889|NCT01130532|144689063|SUPERIORITY_OR_OTHER||LS Mean Difference|19.5|STANDARD_ERROR_OF_MEAN|2.2|<|0.001||95.0||||P-value is for pleasure from sexual activity. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|ANCOVA|||||||<0.001
72411658|NCT00406029|144331704|SUPERIORITY_OR_OTHER||Difference in LS Means|0.1||||0.93|TWO_SIDED|95.0|-1.5|1.6|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.6|-1.5|0.930
72411659|NCT00406029|144331704|SUPERIORITY_OR_OTHER||Difference in LS Means|0.3||||0.759|TWO_SIDED|95.0|-1.5|2.1|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.||2.1|-1.5|0.759
72579890|NCT01130532|144689063|SUPERIORITY_OR_OTHER||LS Mean Difference|26.0|STANDARD_ERROR_OF_MEAN|2.54|<|0.001||95.0||||P-value is for erectile function satisfaction. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|ANCOVA|||||||<0.001
72579891|NCT01130532|144689063|SUPERIORITY_OR_OTHER||LS Mean Difference|28.7|STANDARD_ERROR_OF_MEAN|2.53|<|0.001||95.0||||P-value is for erectile function satisfaction. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|ANCOVA|||||||<0.001
72411660|NCT00406029|144331704|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.8||||0.374|TWO_SIDED|95.0|-2.4|0.9|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.9|-2.4|0.374
72411661|NCT00406029|144331704|SUPERIORITY_OR_OTHER||Difference in LS Means|0.4||||0.621|TWO_SIDED|95.0|-1.3|2.1|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.||2.1|-1.3|0.621
72411662|NCT00406029|144331704|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.4||||0.607|TWO_SIDED|95.0|-2.1|1.2|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.2|-2.1|0.607
72411663|NCT00406029|144331704|SUPERIORITY_OR_OTHER||Difference in LS Means|0.1||||0.907|TWO_SIDED|95.0|-1.4|1.6|||ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.6|-1.4|0.907
72411664|NCT00406029|144331704|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.7||||0.368|TWO_SIDED|95.0|-2.1|0.8|||ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.8|-2.1|0.368
72411665|NCT00406029|144331704|SUPERIORITY_OR_OTHER||Difference in LS Means|0.3||||0.654|TWO_SIDED|95.0|-1.1|1.8|||ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.8|-1.1|0.654
72411666|NCT00406029|144331704|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.2||||0.769|TWO_SIDED|95.0|-1.7|1.2|||ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.2|-1.7|0.769
72579892|NCT01130532|144689063|SUPERIORITY_OR_OTHER||LS Mean Difference|19.3|STANDARD_ERROR_OF_MEAN|2.65|<|0.001||95.0||||P-value is for satisfaction with orgasm. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|ANCOVA|||||||<0.001
72579893|NCT01130532|144689063|SUPERIORITY_OR_OTHER||LS Mean Difference|20.1|STANDARD_ERROR_OF_MEAN|2.64|<|0.001||95.0||||P-value is for satisfaction with orgasm. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|ANCOVA|||||||<0.001
72579894|NCT01130532|144689064|SUPERIORITY_OR_OTHER||LS Mean Difference|28.9|STANDARD_ERROR_OF_MEAN|2.77|<|0.001||95.0||||Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|ANOVA|||||||<0.001
72579895|NCT01130532|144689064|SUPERIORITY_OR_OTHER||LS Mean Difference|31.0|STANDARD_ERROR_OF_MEAN|2.76|<|0.001||95.0||||Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|ANOVA|||||||<0.001
72579896|NCT01130532|144689065|SUPERIORITY_OR_OTHER||LS Mean Difference|0.9|STANDARD_ERROR_OF_MEAN|0.11|<|0.001||95.0||||Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|ANCOVA|||||||<0.001
72579897|NCT01130532|144689065|SUPERIORITY_OR_OTHER||LS Mean Difference|1.0|STANDARD_ERROR_OF_MEAN|0.11|<|0.001||95.0||||Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|ANCOVA|||||||<0.001
72579898|NCT01130532|144689066|SUPERIORITY_OR_OTHER||LS Mean Difference|21.7|STANDARD_ERROR_OF_MEAN|2.81|<|0.001||95.0||||P-value is for confidence to complete sexual activity. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|ANCOVA|||||||<0.001
72411667|NCT00406029|144331705|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.5||||0.055|TWO_SIDED|95.0|-1.0|0.0|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.0|-1.0|0.055
72411668|NCT00406029|144331705|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.5||||0.071|TWO_SIDED|95.0|-1.0|0.0|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.0|-1.0|0.071
72579899|NCT01130532|144689066|SUPERIORITY_OR_OTHER||LS Mean Difference|25.2|STANDARD_ERROR_OF_MEAN|2.78|<|0.001||95.0||||P-value is for confidence to complete sexual activity. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|ANCOVA|||||||<0.001
72411669|NCT00406029|144331705|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.3||||0.288|TWO_SIDED|95.0|-0.8|0.2|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.2|-0.8|0.288
72579900|NCT01130532|144689066|SUPERIORITY_OR_OTHER||LS Mean Difference|22.3|STANDARD_ERROR_OF_MEAN|2.46|<|0.001||95.0||||P-value is for ease of erection. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|ANCOVA|||||||<0.001
72579901|NCT01130532|144689066|SUPERIORITY_OR_OTHER||LS Mean Difference|24.5|STANDARD_ERROR_OF_MEAN|2.44|<|0.001||95.0||||P-value is for ease of erection. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|ANCOVA|||||||<0.001
72579902|NCT01130532|144689066|SUPERIORITY_OR_OTHER||LS Mean Difference|16.9|STANDARD_ERROR_OF_MEAN|2.37|<|0.001||95.0||||P-value is for pleasure from sexual activity. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|ANCOVA|||||||<0.001
72579903|NCT01130532|144689066|SUPERIORITY_OR_OTHER||LS Mean Difference|17.2|STANDARD_ERROR_OF_MEAN|2.35|<|0.001||95.0||||P-value is for pleasure from sexual activity. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|ANCOVA|||||||<0.001
72579904|NCT01130532|144689066|SUPERIORITY_OR_OTHER||LS Mean Difference|25.2|STANDARD_ERROR_OF_MEAN|2.57|<|0.001||95.0||||P-value is for erectile function satisfaction. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|ANCOVA|||||||<0.001
72579905|NCT01130532|144689066|SUPERIORITY_OR_OTHER||LS Mean Difference|25.1|STANDARD_ERROR_OF_MEAN|2.56|<|0.001||95.0||||P-value is for erectile function satisfaction. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|ANCOVA|||||||<0.001
72579906|NCT01130532|144689066|SUPERIORITY_OR_OTHER||LS Mean Difference|15.1|STANDARD_ERROR_OF_MEAN|2.88|<|0.001||95.0||||P-value is for satisfaction with orgasm. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|ANCOVA|||||||<0.001
72579907|NCT01130532|144689066|SUPERIORITY_OR_OTHER||LS Mean Difference|17.3|STANDARD_ERROR_OF_MEAN|2.86|<|0.001||95.0||||P-value is for satisfaction with orgasm. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|ANCOVA|||||||<0.001
72579908|NCT01130532|144689067|SUPERIORITY_OR_OTHER||LS Mean Difference|25.1|STANDARD_ERROR_OF_MEAN|2.76|<|0.001||95.0||||Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|ANOVA|||||||<0.001
72579909|NCT01130532|144689067|SUPERIORITY_OR_OTHER||LS Mean Difference|28.2|STANDARD_ERROR_OF_MEAN|2.74|<|0.001||95.0||||Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|ANOVA|||||||<0.001
72579910|NCT01130532|144689069|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Comparison of Week 16 to Week 12. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|Paired t-test|||||||<0.001
72579911|NCT01130532|144689069|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Comparison of Week 16 to Week 12. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|Paired t-test|||||||<0.001
72579912|NCT01130532|144689069|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Comparison of Week 16 to Week 12. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|Paired t-test|||||||<0.001
72579913|NCT01130532|144689070|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||Comparison of Week 16 to Week 12. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|Paired t-test|||||||0.002
72579914|NCT01130532|144689070|SUPERIORITY_OR_OTHER|||||||0.004||95.0||||Comparison of Week 16 to Week 12. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|Paired t-test|||||||0.004
72579915|NCT01130532|144689070|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Comparison of Week 16 to Week 12. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|Paired t-test|||||||<0.001
72579916|NCT03041311|144689077|SUPERIORITY||||||<|0.0001|ONE_SIDED|95.0||||A Hochberg-based gatekeeping procedure was used to control the global familywise error rate across the multiple null hypotheses (for 2 primary and 3 key secondary endpoints) in a strong sense at a 1-sided 0.025 level.|non-parametric ANCOVA|Hochberg-based gatekeeping procedure||Treatment difference was evaluated using a nonparametric analysis of covariance (ANCOVA). The nonparametric ANCOVA included study baseline ANC value as covariate, stratification factors of ECOG performance status (0 to 1 versus 2) and brain metastases (Yes versus No), and treatment as a fixed effect.||||<0.0001
72579917|NCT03041311|144689078|SUPERIORITY||||||<|0.0001||||||A Hochberg-based gatekeeping procedure was used to control the global familywise error rate across the multiple null hypotheses (for 2 primary and 3 key secondary endpoints) in a strong sense at a 1-sided 0.025 level.|Modified Poisson|Hochberg-based gatekeeping procedure||The occurrence of SN was a binary variable. Treatment group difference was analyzed using a modified Poisson regression model to account for the variable duration of the Induction Period for each patient. The model included baseline ANC count as a covariate, the stratification factors of ECOG performance status (0 to1 vs. 2) and brain metastases (Yes vs. No), and treatment as a fixed effect. The logarithm transformation of # of Induction cycles was included as an offset variable in the modeling.||||<0.0001
72579918|NCT03041311|144689079|SUPERIORITY|||||||0.0195||||||A Hochberg-based gatekeeping procedure was used to control the global familywise error rate across the multiple null hypotheses (for 2 primary and 3 key secondary endpoints) in a strong sense at a 1-sided 0.025 level.|negative binomial regression|Hochberg-based gatekeeping procedure||||||0.0195
72411670|NCT00406029|144331705|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.1||||0.764|TWO_SIDED|95.0|-0.6|0.4|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.4|-0.6|0.764
72545454|NCT00803959|144620056|SUPERIORITY_OR_OTHER|||||||0.5||95.0||||P-value not adjusted for multiple comparisons; a priori threshold was alpha = 0.05.|t-test, 2 sided|The t test had 1 df assuming equal variances; no evidence of unequal variances was found.||Null hypothesis is that the 2 arms do not differ in change in MESA stress score.||||0.50
72545455|NCT00803959|144620057|SUPERIORITY_OR_OTHER|||||||0.19||95.0||||P-value not adjusted for multiple comparisons and a priori threshold for statistical significance set at alpha = 0.05.|t-test, 2 sided|The t test had 1 df and assumed equal variances; no evidence of different variances was found.||Null hypothesis is that the two arms do not differ according to change in MESA urgency score.||||0.19
72545456|NCT00803959|144620058|SUPERIORITY_OR_OTHER|||||||0.49||95.0||||P-value not adjusted for multiple comparisons and a priori threshold for statistical significance set at alpha = 0.05|t-test, 2 sided|T test had 1 df and assumed equal variance; no evidence of different variances was found.||Null hypothesis is that the 2 arms do not differ according to mean change in IIQ score.||||0.49
72545457|NCT00803959|144620059|SUPERIORITY_OR_OTHER|||||||0.02||95.0||||P-value not adjusted for multiple comparisons and a priori threshold for statistical significance set at alpha = 0.05.|t-test, 2 sided|T test had 1 df assuming equal variances; no evidence of unequal variances was found.||Null hypothesis is that the 2 arms do not differ according to mean change in SF-12 scores.||||0.02
72545458|NCT00803959|144620060|SUPERIORITY_OR_OTHER|||||||0.51||95.0|||||t-test, 2 sided|The t test had 1 df and assumed equal variance; no evidence of different variances was found.||Null hypothesis is that the 2 arms do not differ according to mean change in PGI-S score.||||0.51
72579919|NCT03041311|144689080|SUPERIORITY|||||||0.1335||||||A Hochberg-based gatekeeping procedure was used to control the global familywise error rate across the multiple null hypotheses (for 2 primary and 3 key secondary endpoints) in a strong sense at a 1-sided 0.025 level.|Modified Poisson|Hochberg-based gatekeeping procedure||Treatment group difference was analyzed using a modified Poisson regression model. The model included baseline hemoglobin as a covariate, the stratification factors of ECOG performance status (0 to 1 versus 2) and brain metastases (Yes versus No) and treatment as a fixed effect. The logarithm transformation of the number of weeks on treatment was included as an offset variable in the model.||||0.1335
72579920|NCT03041311|144689081|SUPERIORITY|||||||0.0686||||||A Hochberg-based gatekeeping procedure was used to control the global familywise error rate across the multiple null hypotheses (for 2 primary and 3 key secondary endpoints) in a strong sense at a 1-sided 0.025 level.|Modified Poisson|Hochberg-based gatekeeping procedure||Treatment group difference was analyzed using a modified Poisson regression model to account for the variable duration of the Induction Period for each patient. The model included baseline absolute neutrophil count as a covariate, the stratification factors of ECOG performance status (0 to 1 versus 2) and brain metastases (Yes versus No), and treatment as a fixed effect. The logarithm transformation of number of Induction cycles was included as an offset variable in the modeling.||||0.0686
72545459|NCT00803959|144620061|SUPERIORITY_OR_OTHER|||||||0.51||95.0|||||Chi-squared|Chi-squared test had 1 df and no adjustments.||Null hypothesis is that the 2 arms do not differ in the proportion of women who score moderate or severe on the PGI-S at 12 months||||0.51
72579921|NCT03041311|144689082|SUPERIORITY|For time-to-event variable, the Kaplan-Meier method was used to estimate its within group median value, 25% and 75% percentile values.|Hazard Ratio (HR)|0.99|STANDARD_ERROR_OF_MEAN|0.218||0.9942|TWO_SIDED|95.0|0.64|1.52||The 2-sided p-value was obtained from the stratified log-rank test to account for the stratification factors.|Log Rank|stratified log-rank test|The HR and its 95% CI were calculated using the Cox proportional hazard regression model with treatment and stratification factors of ECOG performance status (0 to 1 versus 2) and presence of brain metastases (Yes versus No).|||1.52|0.64|0.9942
72579922|NCT04909853|144689113|OTHER||Ratio of Adjusted Geometric Means|129.78|||||TWO_SIDED|90.0|101.93|165.25|||||Analysis used one-way ANOVA model with renal function as a fixed effect. The ratio of adjusted geometric means (test \[impaired\]/reference \[normal\]) and 90% confidence interval (CI) were expressed as percentages.|||165.25|101.93|
72545460|NCT00803959|144620062|SUPERIORITY_OR_OTHER|||||||0.28||95.0||||P-value was not adjusted for multiple comparisons and the a priori threshold for statistical significance was alpha = 0.05.|t-test, 2 sided|T test had 1 df and assumed equal variances; no evidence of unequal variances was found.||Null hypothesis is that the 2 arms do not differ according to mean overall patient satisfaction score at 12 months.||||0.28
72545461|NCT00803959|144620063|SUPERIORITY_OR_OTHER|||||||0.19||95.0||||P-values was not adjusted for multiple comparisons and the a priori threshold for statistical significance was set at alpha = 0.05.|Chi-squared|Chi-squared test had 1 df and no adjustments.||Null hypothesis is that the proportion having a positive provocative stress test at 12 months was the same in both treatment arms.||||0.19
72552596|NCT01015625|144636041|SUPERIORITY|A two-sided significance level of 5% was used.|Cox Proportional Hazard|0.95||||0.89|TWO_SIDED|95.0|0.45|2.02|||Log Rank||From the Cox Proportional hazard model with surgery vs no surgery fitted as a covariate. A hazard ratio \> 1.0 indicates a higher average event rate and a shorter time to local progression for surgery relative to no surgery.|To determine the effect of local therapy (surgery) compared to systemic therapy only in synchronous metastasized breast cancer patients in terms of time from randomization to local progression. Local progression is defined as recurrence in breast with localization mamma, chest wall or axilla. Participants last known to be alive, who did not experience a local progression were censored at their last contact date or at the data cut-off date whichever came first.||2.02|0.45|0.890
72579923|NCT04909853|144689113|OTHER||Ratio of Adjusted Geometric Means|138.12|||||TWO_SIDED|90.0|113.18|168.55|||||Analysis used one-way ANOVA model with renal function as a fixed effect. The ratio of adjusted geometric means (test \[impaired\]/reference \[normal\]) and 90% confidence interval (CI) were expressed as percentages.|||168.55|113.18|
72411671|NCT00406029|144331705|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.3||||0.342|TWO_SIDED|94.0|-0.9|0.3|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.3|-0.9|0.342
72411672|NCT00406029|144331705|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.2||||0.611|TWO_SIDED|95.0|-0.7|0.4|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.4|-0.7|0.611
72579924|NCT04909853|144689113|OTHER||Ratio of Adjusted Geometric Means|148.02|||||TWO_SIDED|90.0|111.4|196.68|||||Analysis used one-way ANOVA model with renal function as a fixed effect. The ratio of adjusted geometric means (test \[impaired\]/reference \[normal\]) and 90% confidence interval (CI) were expressed as percentages.|||196.68|111.40|
72579925|NCT04909853|144689114|OTHER||Ratio of Adjusted Geometric Means|123.84|||||TWO_SIDED|90.0|99.64|153.91|||||Analysis used one-way ANOVA model with renal function as a fixed effect. The ratio of adjusted geometric means (test \[impaired\]/reference \[normal\]) and 90% confidence interval (CI) were expressed as percentages.|||153.91|99.64|
72579926|NCT04909853|144689114|OTHER||Ratio of Adjusted Geometric Means|187.4|||||TWO_SIDED|90.0|148.52|236.46|||||Analysis used one-way ANOVA model with renal function as a fixed effect. The ratio of adjusted geometric means (test \[impaired\]/reference \[normal\]) and 90% confidence interval (CI) were expressed as percentages.|||236.46|148.52|
72579927|NCT04909853|144689114|OTHER||Ratio of Adjusted Geometric Means|304.49|||||TWO_SIDED|90.0|237.6|390.21|||||Analysis used one-way ANOVA model with renal function as a fixed effect. The ratio of adjusted geometric means (test \[impaired\]/reference \[normal\]) and 90% confidence interval (CI) were expressed as percentages.|||390.21|237.60|
72579928|NCT01811472|144689170|NON_INFERIORITY_OR_EQUIVALENCE|The power calculation was largely driven by the maximum true response assumed in the candidate response shapes, which is a difference of -5.2% for pradigastat vs placebo for the primary endpoint.|Mean Difference (Net)|-1.69||||0.3128|TWO_SIDED|90.0|-4.46|1.09|||Mixed Model of Repeated Measurements|Degrees of freedom are adjusted using the Kenward-Roger method.||Hypothesis was tested at the 1-sided 5% significance level to assess if LCQ908 5mg/10mg was different from placebo.||1.09|-4.46|0.3128
72579929|NCT01811472|144689170|NON_INFERIORITY_OR_EQUIVALENCE|The power calculation was largely driven by the maximum true response assumed in the candidate response shapes, which is a difference of -5.2% for pradigastat vs placebo for the primary endpoint.|Mean Difference (Net)|-2.89||||0.0457|TWO_SIDED|90.0|-5.25|-0.53|||Mixed Model of Repeated Measurements|Degrees of freedom are adjusted using the Kenward-Roger method.||Hypothesis was tested at the 1-sided 5% significance level to assess if LCQ908 10mg/20mg was different from placebo.||-0.53|-5.25|0.0457
72579930|NCT03105518|144689192|SUPERIORITY||1 way test, chisquare approximation|7.188||||0.007|TWO_SIDED||||||Kruskal-Wallis|||VAS at Time 0; Follicles ≤10 vs. \> 10||||0.007
72579931|NCT03105518|144689192|SUPERIORITY||1 way Test, ChiSquare Approximation|3.6396||||0.056|TWO_SIDED||||||Kruskal-Wallis|||VAS at Time 15; Follicles ≤10 vs. \> 10||||0.056
72579932|NCT03105518|144689192|SUPERIORITY||1 way Test, ChiSquare Approximation|15.971|||<|0.0001|TWO_SIDED||||||Kruskal-Wallis|||VAS at Time 30; Follicles ≤10 vs. \> 10||||<0.0001
72579933|NCT03105518|144689192|SUPERIORITY||1-way Test, ChiSquare Approximation|16.0972|||<|0.0001|TWO_SIDED||||||Kruskal-Wallis|||VAS at Time 60; Follicles ≤10 vs. \> 10||||<0.0001
72579934|NCT03105518|144689193|SUPERIORITY||1-way Test, ChiSquare Approximation|2.7205||||0.0991|TWO_SIDED||||||Kruskal-Wallis|||VAS at Post Operative Day 1; Follicles ≤10 vs. \> 10||||0.0991
72579935|NCT03105518|144689193|SUPERIORITY||1 way Test, ChiSquare Approximation|1.5654||||0.2109|TWO_SIDED||||||Kruskal-Wallis|||VAS at Post Operative Day 2; Follicles ≤10 vs. \> 10||||0.2109
72579936|NCT03105518|144689193|SUPERIORITY||1-way Test, ChiSquare Approximation|0.008||||0.9287|TWO_SIDED||||||Kruskal-Wallis|||VAS at Post Operative Day 3; Follicles ≤10 vs. \> 10||||0.9287
72579937|NCT05387889|144689194|SUPERIORITY||Mean Difference (Final Values)|0.05|||<|0.054|TWO_SIDED|95.0||||The threshold for the level of significance is set at less than or equal to 0.05|ANCOVA|||||||< 0.054
72579938|NCT05387889|144689195|SUPERIORITY||Mean Difference (Final Values)|0.05|||<|0.25|TWO_SIDED|95.0||||The threshold for the level of significance is set at less than or equal to 0.05|ANCOVA|||||||< 0.25
72579939|NCT05387889|144689196|SUPERIORITY||Mean Difference (Final Values)|0.05|||<|0.07|TWO_SIDED|95.0||||The threshold for the level of significance is set at less than or equal to 0.05|ANCOVA|||||||< 0.07
72579940|NCT02064296|144689215|SUPERIORITY|||||||0.333|||||||t-test, 2 sided|||Salience co-activation pattern at rest vs. with pressure pain.||||0.3330
72411673|NCT00406029|144331705|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.2||||0.424|TWO_SIDED|95.0|-0.8|0.3|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.3|-0.8|0.424
72579941|NCT02064296|144689215|SUPERIORITY|||||||0.6474|||||||t-test, 2 sided|||This statistical analysis covers the sensorimotor co-activation pattern at rest vs. with pressure pain for Healthy controls||||0.6474
72579942|NCT02064296|144689215|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||Salience co-activation pattern at rest vs. with pressure pain||||<0.0001
72579943|NCT02064296|144689215|SUPERIORITY|||||||0.0004|||||||t-test, 2 sided|||This statistical analysis covers the sensorimotor co-activation pattern at rest vs. with pressure pain for Fibromyalgia patients||||0.0004
72579944|NCT02064296|144689216|SUPERIORITY|||||||0.0653|||||||t-test, 2 sided|||This is a comparison of Mock Laser Acupuncture pre-and post 4 weeks of treatment.||||0.0653
72579945|NCT02064296|144689216|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||This is a P value for the change in Traditional Acupuncture, pre and post 4 weeks of treatment.||||<0.0001
72411674|NCT00406029|144331705|SUPERIORITY_OR_OTHER||Difference in LS Means|0.0||||0.991|TWO_SIDED|95.0|-0.6|0.6|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.6|-0.6|0.991
72411675|NCT00406029|144331705|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.5||||0.185|TWO_SIDED|95.0|-1.3|0.3|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.3|-1.3|0.185
72411676|NCT00406029|144331705|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.2||||0.597|TWO_SIDED|95.0|-1.0|0.6|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.6|-1.0|0.597
72411677|NCT00406029|144331705|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.7||||0.09|TWO_SIDED|95.0|-1.5|0.1|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.1|-1.5|0.090
72411678|NCT00406029|144331705|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.2||||0.686|TWO_SIDED|95.0|-0.9|0.6|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.6|-0.9|0.686
72411679|NCT00406029|144331705|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.3||||0.501|TWO_SIDED|95.0|-1.0|0.5|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.5|-1.0|0.501
72411680|NCT00406029|144331705|SUPERIORITY_OR_OTHER||Difference in LS Means|0.1||||0.764|TWO_SIDED|95.0|-0.6|0.8|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.8|-0.6|0.764
72579946|NCT02064296|144689217|SUPERIORITY|||||||0.7399|||||||t-test, 2 sided|||Glx statistical comparison||||0.7399
72579947|NCT02064296|144689217|SUPERIORITY|||||||0.6226|||||||t-test, 2 sided|||Glx statistical comparison||||0.6226
72579948|NCT02064296|144689218|SUPERIORITY|||||||0.6344|||||||t-test, 2 sided|||GABA statistical comparison||||0.6344
72579949|NCT02064296|144689218|SUPERIORITY|||||||0.7985|||||||t-test, 2 sided|||GABA statistical comparison||||0.7985
72579950|NCT03885661|144689237|SUPERIORITY|||||||0.65|||||||mixed effects regression|testing for the outcome employed mixed effects regression. The key fixed effects were group assignment, period, and the group X period interaction.||||||0.65
72579951|NCT03282916|144689250|SUPERIORITY|Linear mixed-effects models (LMM) were used to assess the treatment effects on the outcome with change score from baseline as the dependent variable and treatment, study time point, and their interaction as predictors, adjusting for baseline value of the outcome.|Mean Difference (Final Values)|3.91|||<|0.05|TWO_SIDED|95.0|1.03|6.8||Not adjusted for multiple comparisons|Mixed Models Analysis|Adjusting for baseline value of ADAS-Cog11||"Null hypothesis: there is no difference in change in ADAS-Cog11 between valacyclovir and placebo treatment.~A sample size of 130 participants (65 per arm) was originally projected to detect Cohen's d of 0.50 with 80% power at 5% significance level. Recruitment target was reduced to 120 participants due to pandemic-related recruitment delays and required study completion within the extended funding timeline. For n=120, the minimum detectable effect size increased slightly to Cohen's d of 0.52."||6.80|1.03|<0.05
72579952|NCT00489255|144689260|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.43||||0.09|TWO_SIDED|95.0|0.17|1.11|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test for treatment was stratified by site.||The null hypothesis was no difference between treatments.||1.11|0.17|0.09
72579953|NCT00489255|144689261|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.44||||0.025|TWO_SIDED|95.0|0.21|0.9|||Cochran-Mantel-Haenszel|||||0.90|0.21|0.025
72579954|NCT00489255|144689262|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.25||||0.005|TWO_SIDED|95.0|0.09|0.7|||Cochran-Mantel-Haenszel|||||0.70|0.09|0.005
72579955|NCT00489255|144689263|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.75||||0.65|TWO_SIDED|95.0|0.23|2.48|||Cochran-Mantel-Haenszel|||||2.48|0.23|0.65
72579956|NCT00489255|144689264|SUPERIORITY_OR_OTHER||Median Difference (Net)|-0.21||||0.32|TWO_SIDED|95.0|-0.64|0.21|||ANOVA|Treatment effect in ANOVA was adjusted for site.||||0.21|-0.64|0.32
72579957|NCT00489255|144689265|SUPERIORITY_OR_OTHER||Median Difference (Net)|-1.07||||0.001|TWO_SIDED|95.0|-1.71|-0.43|||ANOVA|||||-0.43|-1.71|0.001
72579958|NCT00489255|144689266|SUPERIORITY_OR_OTHER||Median Difference (Net)|-0.01||||0.95|TWO_SIDED|95.0|-0.2|0.19|||ANOVA|||||0.19|-0.20|0.95
72579959|NCT00489255|144689267|SUPERIORITY_OR_OTHER|||||||0.88|TWO_SIDED|95.0|||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test (row mean score) with rigid scores, stratified by site||||||0.88
72579960|NCT00489255|144689268|SUPERIORITY_OR_OTHER|||||||0.019||95.0|||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test (row mean score) with rigid scores, stratified by site||||||0.019
72579961|NCT00489255|144689269|SUPERIORITY_OR_OTHER|||||||0.29||95.0|||||Cochran-Mantel-Haenszel|||||||0.29
72579962|NCT00489255|144689270|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.7||||0.17|TWO_SIDED|95.0|0.5|1.1||Cox's proportional hazards model with site and treatment (Tigan/placebo) as factors.|Regression, Cox|||||1.1|0.5|0.17
72579963|NCT00489255|144689271|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.3||||0.008|TWO_SIDED|95.0|0.1|0.7||Cox's proportional hazards model with site and treatment (Tigan/placebo) as factors.|Regression, Cox|||||0.7|0.1|0.008
72329495|NCT00443872|144184450|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.2|||<|0.01|TWO_SIDED|95.0|||||t-test, 2 sided||Comparison of baseline vs. 3 month circumference of the Left and Right lower leg/ankle (change identical for both legs).|Change in pedal edema as measured by change in lower leg/ankle circumference in the left and right legs||||<0.01
72552597|NCT02728102|144636042|SUPERIORITY||difference in the proportions|2.9||||0.3657|TWO_SIDED|80.0|-8.8|14.6||A one-sided significance level of 0.10 is used to assess whether the vaccine appears promising relative to control.|Z test|||The proportion of patients alive and in CR/sCR at 1 year post transplant will be described in the vaccine and no vaccine groups with 80% confidence intervals and compared between groups using a two-sample Z test comparing binomial proportions.||14.6|-8.8|0.3657
72579964|NCT00489255|144689272|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.9||||0.49|TWO_SIDED|95.0|0.6|1.3||Cox's proportional hazards model with site and treatment (Tigan/placebo) as factors.|Regression, Cox|||||1.3|0.6|0.49
72579965|NCT00489255|144689273|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.2||||0.4|TWO_SIDED|95.0|0.7|2.1|||Regression, Cox|||||2.1|0.7|0.4
72579966|NCT00489255|144689274|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.2||||0.62||95.0|0.6|2.3||Cox's proportional hazards model with site and treatment (Tigan/placebo) as factors.|Regression, Cox|||||2.3|0.6|0.62
72579967|NCT00489255|144689275|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.08||||0.96|TWO_SIDED|95.0|-3.59|3.76|||ANOVA|ANCOVA model with baseline score (score at Visit 1/Screening) as a covariate, and site and treatment as factors.||||3.76|-3.59|0.96
72579968|NCT00489255|144689276|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.18||||0.93|TWO_SIDED|95.0|-4.37|4.02|||ANOVA|||||4.02|-4.37|0.93
72579969|NCT00489255|144689277|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.39||||0.84|TWO_SIDED|95.0|-4.12|3.34|||ANOVA|||||3.34|-4.12|0.84
72579970|NCT00489255|144689278|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.97||||0.25|TWO_SIDED|95.0|-2.17|8.11|||ANOVA|||||8.11|-2.17|0.25
72579971|NCT00489255|144689279|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.47||||0.46|TWO_SIDED|95.0|-2.47|5.4|||ANOVA|||||5.40|-2.47|0.46
72579972|NCT00489255|144689280|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.96||||0.33|TWO_SIDED|95.0|-3.13|9.06|||ANOVA|||||9.06|-3.13|0.33
72579973|NCT00489255|144689281|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.27||||0.93|TWO_SIDED|95.0|-5.57|6.11|||ANOVA|||||6.11|-5.57|0.93
72579974|NCT04995029|144689338|SUPERIORITY|Any missed or skipped visit was counted as non-negative or de-facto positive. Difference between DB treatment arms was compared using CMH test accounting for randomization stratification (Opioid injection: Yes/No, Week 6 UDS Fentanyl result: Positive/Negative). Statistical superiority was declared if CMH weighted difference in proportion of responders in the 300-mg arm minus the proportion of responders in the 100-mg arm was \>0 and the 2-sided P-value of CMH test ≤0.05.|CMH treatment difference|2.62||||0.4819|TWO_SIDED|95.0|-4.69|9.93||CMH weighted treatment difference and P-value based on CMH randomization stratified analysis using Sato (1989) variance equation. Treatment difference estimate calculated as weighted average of strata-specific estimates within each analysis stratum.|Cochran-Mantel-Haenszel|Difference between DB treatment arms was compared using CMH test accounting for randomization stratification.||"Based on Phase 3 results, for the primary efficacy endpoint of INDV-6000-401, a sample size of 195 per arm was estimated to provide approximately 90% power at 2-sided 0.05 alpha level to detect a difference of 15.6%.~Since the participant population in this study had more severe OUD compared with the Phase 3 DB study, the responder rates and treatment differences were anticipated to be lower."||9.93|-4.69|0.4819
72579975|NCT04995029|144689338|SUPERIORITY|Any missed or skipped visit was counted as non-negative or de-facto positive. Difference between DB treatment arms was compared using CMH test accounting for randomization stratification (Opioid injection: Yes/No, Week 6 UDS Fentanyl result: Positive/Negative). Statistical superiority was declared if CMH weighted difference in proportion of responders in the 300-mg arm minus the proportion of responders in the 100-mg arm was \>0 and the 2-sided P-value of CMH test ≤0.05.|CMH treatment difference|12.24|||||TWO_SIDED|95.0|2.35|22.12|||||CMH weighted treatment difference based on CMH randomization stratified analysis using Sato (1989) variance equation. Treatment difference estimate calculated as weighted average of strata-specific estimates within each analysis stratum.|Post-hoc subgroup analyses of the primary endpoint to characterize the population of patients who would benefit from the higher maintenance dosing regimen identified participants who reported using fentanyl ≥14 times per week at Screening as one such group.|The posterior possibility of responder rate difference (300 mg-100 mg) \>0 was estimated (via Bayesian beta-binomial model using non-informative uniform prior, ie, Beta (1,1), within individual treatment groups) to evaluate the superiority of 300 mg over 100 mg. Bayesian posterior probability of superiority 300-mg dose to 100-mg dose=99.099%.|22.12|2.35|
72579976|NCT04995029|144689338|SUPERIORITY|Any missed or skipped visit was counted as non-negative or de-facto positive. Difference between DB treatment arms was compared using CMH test accounting for randomization stratification (Opioid injection: Yes/No, Week 6 UDS Fentanyl result: Positive/Negative). Statistical superiority was declared if CMH weighted difference in proportion of responders in the 300-mg arm minus the proportion of responders in the 100-mg arm was \>0 and the 2-sided P-value of CMH test ≤0.05.|CMH treatment difference|11.06|||||TWO_SIDED|95.0|0.36|21.56|||||CMH weighted treatment difference and P-value based on CMH randomization stratified analysis using Sato (1989) variance equation. Treatment difference estimate calculated as weighted average of strata-specific estimates within each analysis stratum.|Post-hoc subgroup analyses of the primary endpoint to characterize the population of patients who would benefit from the higher maintenance dosing regimen identified participants who reported using fentanyl daily at Screening as one such group.|The posterior possibility of responder rate difference (300 mg-100 mg) \>0 was estimated (via Bayesian beta-binomial model using non-informative uniform prior, ie, Beta (1,1), within individual treatment groups) to evaluate the superiority of 300 mg over 100 mg. Bayesian posterior probability of superiority of 300-mg dose to 100-mg dose=97.846%|21.56|0.36|
72411681|NCT00406029|144331705|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.1||||0.715|TWO_SIDED|95.0|-0.9|0.6|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.6|-0.9|0.715
72411682|NCT00406029|144331705|SUPERIORITY_OR_OTHER||Difference in LS Means|0.0||||0.924|TWO_SIDED|95.0|-0.7|0.8|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.8|-0.7|0.924
72545462|NCT00434161|144620064|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.679||||0.188|TWO_SIDED|97.5|0.351|1.313||A 2.5% type I error rate for each comparison gives an overall type I error rate of 5%.|Proportional odds model|The proportional odds model including the randomization factors as covariates was used for the primary endpoint, maximum severity of OM.|The odds ratio was defined to be the odds of a subject receiving placebo experiencing OM divided by the odds of a subject receiving palifermin developing OM.|The null hypothesis was that the severity distribution for OM was identical for the placebo and each of the two palifermin groups, and the alternative hypothesis was that palifermin resulted in a shift in the distribution to less severe mucositis than placebo. A total of 275 subjects would give at least 95% power, with a 2.5% type I error rate for each comparison to detect an odds ratio of at least 3.5 between the placebo group and each of the two palifermin groups.||1.313|0.351|0.188
72545463|NCT00434161|144620064|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.242||||0.468|TWO_SIDED|97.5|0.635|2.431||A 2.5% type I error rate for each comparison gives an overall type I error rate of 5%.|Proportional odds model|The proportional odds model including the randomization factors as covariates was used for the primary endpoint, maximum severity of OM.|The odds ratio was defined to be the odds of a subject receiving placebo experiencing OM divided by the odds of a subject receiving palifermin developing OM.|The null hypothesis was that the severity distribution for OM was identical for the placebo and each of the two palifermin groups, and the alternative hypothesis was that palifermin resulted in a shift in the distribution to less severe mucositis than placebo. A total of 275 subjects would give at least 95% power, with a 2.5% type I error rate for each comparison to detect an odds ratio of at least 3.5 between the placebo group and each of the two palifermin groups.||2.431|0.635|0.468
72545464|NCT00434161|144620065|SUPERIORITY_OR_OTHER||Risk Difference (RD)|13.262||||0.245|TWO_SIDED|97.5|-4.303|30.828||For secondary endpoints the type I error was protected by using the Hochberg procedure. The reported p-values are adjusted by the Hochberg procedure.|Cochran-Mantel-Haenszel|||||30.828|-4.303|0.245
72545465|NCT00434161|144620065|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-2.014||||0.806|TWO_SIDED|97.5|-20.519|16.491||For secondary endpoints the type I error was protected by using the Hochberg procedure. The reported p-values are adjusted by the Hochberg procedure.|Cochran-Mantel-Haenszel|||||16.491|-20.519|0.806
72545466|NCT00434161|144620066|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.409|STANDARD_DEVIATION|6.82||0.095|TWO_SIDED|97.5|0.07|4.748||For secondary endpoints the type I error was protected by using the Hochberg procedure. The reported p-values are adjusted by the Hochberg procedure.|van Elteren test|||A type I error rate was protected by using the Hochberg procedure to adjust for multiple testing. Palifermin was not to be declared to be statistically superior to placebo with respect to secondary efficacy endpoints unless the primary endpoint was statistically significant in favor of palifermin.||4.748|0.070|0.095
72411683|NCT00406029|144331705|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.4||||0.264|TWO_SIDED|95.0|-1.2|0.3|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.3|-1.2|0.264
72545467|NCT00434161|144620066|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.213|STANDARD_DEVIATION|6.13||0.806|TWO_SIDED|97.5|-2.575|2.15||For secondary endpoints the type I error was protected by using the Hochberg procedure. The reported p-values are adjusted by the Hochberg procedure.|van Elteren test|||||2.150|-2.575|0.806
72545468|NCT00434161|144620067|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|15.436||||0.142|TWO_SIDED|97.5|-1.542|32.415||For secondary endpoints the type I error was protected by using the Hochberg procedure. The reported p-values are adjusted by the Hochberg procedure.|van Elteren test|||For the secondary endpoints, the type I error rate was protected by using the Hochberg procedure to adjust for multiple testing16. Palifermin was not to be declared to be statistically superior to placebo with respect to secondary efficacy endpoints unless the primary endpoint was statistically significant in favor of palifermin.||32.415|-1.542|0.142
72545469|NCT00434161|144620067|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.331||||0.806|TWO_SIDED|97.5|-11.82|22.482||For secondary endpoints the type I error was protected by using the Hochberg procedure. The reported p-values are adjusted by the Hochberg procedure.|van Elteren test|||||22.482|-11.820|0.806
72545470|NCT00434161|144620068|SUPERIORITY_OR_OTHER||Risk Difference (RD)|5.88|||||TWO_SIDED|95.0|-21.669|33.43||According to statistical analysis plan it was not planned to calculate any P-Value.||||||33.43|-21.669|
72545471|NCT00434161|144620070|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.023|||||TWO_SIDED|95.0|-0.134|0.181||||||||0.181|-0.134|
72545472|NCT00434161|144620071|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.061|||||TWO_SIDED|95.0|-0.138|0.26||||||||0.260|-0.138|
72545473|NCT00434161|144620072|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-3.689|||||TWO_SIDED|95.0|-21.641|14.264||||||||14.264|-21.641|
72545474|NCT00434161|144620073|SUPERIORITY_OR_OTHER||Risk Difference (RD)|5.951|||||TWO_SIDED|95.0|-0.679|12.58||||||||12.580|-0.679|
72545475|NCT00434161|144620075|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.64||||0.192|TWO_SIDED|95.0|0.33|1.26|||Log Rank|||All comparisons for the long-term safety endpoints were based on the combined palifermin group (pre- and post- high dose chemotherapy and pre-high dose chemotherapy only) versus placebo (placebo over palifermin). Overall survival was analyzed using the Kaplan-Meier method. Kaplan-Meier estimates were provided together with the 95% confidence interval.||1.26|0.33|0.192
72545476|NCT00434161|144620076|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|17.417|||||TWO_SIDED|95.0|-11.086|45.919||||||||45.919|-11.086|
72329496|NCT00443872|144184451|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.8|||<|0.05|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.05
72411684|NCT00406029|144331705|SUPERIORITY_OR_OTHER||Difference in LS Means|0.0||||0.976|TWO_SIDED|95.0|-0.7|0.7|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.7|-0.7|0.976
72545477|NCT00434161|144620077|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.8||||0.236|TWO_SIDED|95.0|0.55|1.16|||Log Rank|||All comparisons for the long-term safety endpoints were based on the combined palifermin group (pre- and post- high dose chemotherapy and pre-high dose chemotherapy only) versus placebo (placebo over palifermin). Overall survival was analyzed using the Kaplan-Meier method. Kaplan-Meier estimates were provided together with the 95% confidence interval.||1.16|0.55|0.236
72329497|NCT00443872|144184452|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.6|||<|0.01|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||This analysis is for the Activities of Daily Living (ADL) section of the scale||||<0.01
72545478|NCT00434161|144620078|SUPERIORITY_OR_OTHER||Hazard Ratio, log|0.84||||0.372|TWO_SIDED|95.0|0.58|1.23|||Log Rank|||All comparisons for the long-term safety endpoints were based on the combined palifermin group (pre- and post- high dose chemotherapy and pre-high dose chemotherapy only) versus placebo (placebo over palifermin). Overall survival was analyzed using the Kaplan-Meier method. Kaplan-Meier estimates were provided together with the 95% confidence interval.||1.23|0.58|0.372
72545479|NCT03342898|144620080|NON_INFERIORITY|Non-inferiority of the immune response was performed only between YF + TDV (Group 3) and YF + Placebo (Group 1) at Day 120. Non-inferiority between Group 3 and Group 1 was concluded if the upper bound of the 95% CI for the seroprotection rate difference (Group 1 - Group 3) was less than 5%.|Seroprotection Rate Difference|0.4|||||TWO_SIDED|95.0|-1.85|2.69|||||The Newcombe score method was used to compute the 95% CI of the seroprotection rate difference.|||2.69|-1.85|
72545480|NCT03342898|144620081|NON_INFERIORITY|Non-inferiority of the immune response was performed only between TDV + YF (Group 3) and TDV + Placebo (Group 2) at Day 120. Non-inferiority between Group 3 and Group 2 was concluded if the upper bound of the 95% CI for the GMT ratio (Group 2/Group 3) was less than 2.0.|Geometric Mean Ratio|1.6|||||TWO_SIDED|95.0|1.19|2.22|||||Analysis of variance (ANOVA) model was used for analysis, including log-transformed value of titer as the dependent variable and trial group as a factor.|Day 120, DENV-1||2.22|1.19|
72545481|NCT03342898|144620081|NON_INFERIORITY|Non-inferiority of the immune response was performed only between TDV + YF (Group 3) and TDV + Placebo (Group 2) at Day 120. Non-inferiority between Group 3 and Group 2 was concluded if the upper bound of the 95% CI for the GMT ratio (Group 2/Group 3) was less than 2.0.|Geometric Mean Ratio|1.3||||||95.0|1.03|1.75|||||ANOVA model was used for analysis, including log-transformed value of titer as the dependent variable and trial group as a factor.|Day 120, DENV-2||1.75|1.03|
72545482|NCT03342898|144620081|NON_INFERIORITY|Non-inferiority of the immune response was performed only between TDV + YF (Group 3) and TDV + Placebo (Group 2) at Day 120. Non-inferiority between Group 3 and Group 2 was concluded if the upper bound of the 95% CI for the GMT ratio (Group 2/Group 3) was less than 2.0.|Geometric Mean Ratio|1.3||||||95.0|0.99|1.61|||||ANOVA model was used for analysis, including log-transformed value of titer as the dependent variable and trial group as a factor.|Day 120, DENV-3||1.61|0.99|
72545483|NCT03342898|144620081|NON_INFERIORITY|Non-inferiority of the immune response was performed only between TDV + YF (Group 3) and TDV + Placebo (Group 2) at Day 120. Non-inferiority between Group 3 and Group 2 was concluded if the upper bound of the 95% CI for the GMT ratio (Group 2/Group 3) was less than 2.0.|Geometric Mean Ratio|1.1|||||TWO_SIDED|95.0|0.89|1.46|||||ANOVA model was used for analysis, including log-transformed value of titer as the dependent variable and trial group as a factor.|Day 120, DENV-4||1.46|0.89|
72545484|NCT03342898|144620085|NON_INFERIORITY|Non-inferiority of the immune response was performed only between YF + TDV (Group 3) and YF + Placebo (Group 1) at Day 30. Non-inferiority between Group 3 and Group 1 was concluded if the upper bound of the 95% CI for the GMT ratio (Group 1/Group 3) was less than 2.0.|Geometric Mean Ratio|1.0|||||TWO_SIDED|95.0|0.77|1.26|||||ANOVA model was used for analyses, including the log-transformed value of titer as the dependent variable and trial group as a factor.|||1.26|0.77|
72545485|NCT01387282|144620092|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon rank sum test|||Superiority analysis||||< 0.0001
72545486|NCT01387282|144620093|SUPERIORITY_OR_OTHER|||||||0.648|||||||Wilcoxon rank sum test|||Superiority analysis||||0.6480
72545487|NCT01387282|144620094|SUPERIORITY_OR_OTHER|||||||0.0016|||||||Mixed Models Analysis|||Superiority analysis||||0.0016
72545488|NCT01387282|144620095|SUPERIORITY_OR_OTHER|||||||0.8637|||||||Mixed Models Analysis|||Superiority analysis||||0.8637
72545489|NCT01387282|144620096|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||Superiority analysis||||< 0.0001
72545490|NCT02661126|144620097|OTHER|Geometric least-squares mean ratio (GMR) of AUC0-last in Moderate RI/Healthy Participants.|GMR of AUC0-last in Moderate RI/Healthy|2.02|||||TWO_SIDED|90.0|1.4|2.92||||||||2.92|1.40|
72545491|NCT02661126|144620098|OTHER|GMR of AUC0-∞ in Moderate RI/Healthy Participants|GMR of AUC0-∞ in Moderate RI/Healthy|2.0|||||TWO_SIDED|90.0|1.39|2.89||||||||2.89|1.39|
72545492|NCT02661126|144620099|OTHER|GMR of AUC0-24 in Moderate RI/Healthy Participants|GMR of AUC0-24 in Moderate RI/Healthy|2.02|||||TWO_SIDED|90.0|1.39|2.92||||||||2.92|1.39|
72545493|NCT02661126|144620100|OTHER|GMR of Cmax in Moderate RI/Healthy Participants|GMR of Cmax in Moderate RI/Healthy|1.92|||||TWO_SIDED|90.0|1.35|2.74||||||||2.74|1.35|
72545494|NCT02661126|144620106|OTHER|GMR of AUC0-last in Moderate RI/Healthy Participants.|GMR of AUC0-last in Moderate RI/Healthy|1.94|||||TWO_SIDED|90.0|1.39|2.72||||||||2.72|1.39|
72545495|NCT02661126|144620107|OTHER|GMR of AUC0-∞ in Moderate RI/Healthy Participants|GMR of AUC0-∞ in Moderate RI/Healthy|2.02|||||TWO_SIDED|90.0|1.5|2.74||||||||2.74|1.50|
72545496|NCT02661126|144620108|OTHER|GMR of AUC0-24 in Moderate RI/Healthy Participants|GMR of AUC0-24 in Moderate RI/Healthy|1.72|||||TWO_SIDED|90.0|1.15|2.56||||||||2.56|1.15|
72545497|NCT02661126|144620109|OTHER|GMR of Cmax in Moderate RI/Healthy Participants|GMR of Cmax in Moderate RI/Healthy|1.85|||||TWO_SIDED|90.0|1.2|2.87||||||||2.87|1.20|
72545498|NCT02661126|144620110|OTHER|GMR of C24 in Moderate RI/Healthy Participants|GMR of C24 in Moderate RI/Healthy|2.03|||||TWO_SIDED|90.0|1.38|2.97||||||||2.97|1.38|
72579977|NCT04995029|144689338|SUPERIORITY|Any missed or skipped visit was counted as non-negative or de-facto positive. Difference between DB treatment arms was compared using CMH test accounting for randomization stratification (Opioid injection: Yes/No, Week 6 UDS Fentanyl result: Positive/Negative). Statistical superiority was declared if CMH weighted difference in proportion of responders in the 300-mg arm minus the proportion of responders in the 100-mg arm was \>0 and the 2-sided P-value of CMH test ≤0.05.|CMH treatment difference|15.37|||||TWO_SIDED|95.0|4.61|26.09|||||CMH weighted treatment difference based on CMH randomization stratified analysis using Sato (1989) variance equation. Treatment difference estimate calculated as weighted average of strata-specific estimates within each analysis stratum.|Post-hoc subgroup analyses of the primary endpoint to characterize the population of patients who would benefit from the higher maintenance dosing regimen identified participants who reported using fentanyl ≥14 times per week AND daily at Screening as one such group.|The posterior possibility of responder rate difference (300 mg-100 mg) \>0 was estimated (via Bayesian beta-binomial model using non-informative uniform prior, ie, Beta (1,1), within individual treatment groups) to evaluate the superiority of 300 mg over 100 mg. Bayesian posterior probability of superiority of 300-mg dose to 100-mg dose=99.675%.|26.09|4.61|
72579978|NCT04995029|144689339|NON_INFERIORITY|Estimated by Bayesian beta-binomial model using non-informative uniform prior, ie, Beta (1,1), within individual induction arms. Posterior distribution of retention rate difference between arms was used to calculate posterior probability of NI of RI to SoC induction using a 10% NI margin or favorable trend of RI over SoC induction.|Bayesian beta-binomial model|11.82|||||TWO_SIDED|95.0|4.34|19.03|||||Posterior probability of RI NI to SoC, ie, (RI - SoC)\>10%=100.00%|"Null and alternative statistical hypotheses:~H0: retention rate of RI - SoC induction≤-10% (non-inferiority \[NI\] margin of 10%) HA: retention rate of RI-SoC induction\>-10%. Criterion for success (ie, demonstrating non-inferiority \[NI\]) was based on posterior probability of retention rate difference (RI-SoC)\>-10%. NI of RI to SoC induction was declared if the posterior probability was higher than 96%. The 96% critical value was chosen so that the overall 1-sided Type I error was less than 10%."||19.03|4.34|
72579979|NCT04995029|144689339|SUPERIORITY|The posterior possibility of retention rate difference (RI - SoC) greater than 0 was estimated to evaluate the superiority of RI over SoC induction|Bayesian beta-binomial model|11.82|||||TWO_SIDED|95.0|4.34|19.03|||||Posterior probability that RI treatment is superior to SoC treatment=99.90%|If the non-inferiority of rapid induction (RI) to standard of care (SoC) induction was declared, the posterior possibility of retention rate difference (RI - SoC) greater than 0 was estimated to evaluate the superiority of RI over SoC induction.||19.03|4.34|
72579980|NCT04995029|144689340|SUPERIORITY|A Wilcoxon rank sum test (Van Elteren 1960) stratified for randomisation factors was performed to compare the difference between the 2 treatment arms. The test result P-value was used inferentially, if the primary endpoint test was statistically significant.|Mean Difference (Net)|-1.73||||0.8836|TWO_SIDED|95.0|-6.83|3.36|||Wilcoxon rank sum (Van Elteren)|Wilcoxon rank sum test stratified by DB randomisation factor (Van Elteren, 1960).|Van Elteren Test Z-Score for Difference Between Arms (300 mg - 100 mg)=-0.1464|||3.36|-6.83|0.8836
72579981|NCT04995029|144689341|OTHER||CMH Difference|1.26||||0.6111|TWO_SIDED|95.0|-3.61|6.13|||Cochran-Mantel-Haenszel|CMH weighted treatment difference and p-value based on the CMH randomization stratified analysis using the Sato (1989) variance equation.|CMH weighted treatment difference and p-value based on the CMH randomization stratified analysis using the Sato (1989) variance equation.|Opioid abstinence between Weeks 10 to 38 (inclusive) was derived as the participant's number of visits with negative assessments (defined as negative UDS and TLFB for opioid use) divided by 15. Under this derivation, any missed or skipped visits were counted as positive, in accordance with the composite Intercurrent Events Strategy. The opioid use derivation at a specific visit was the same as that used for the primary efficacy endpoint.||6.13|-3.61|0.6111
72579982|NCT04995029|144689342|OTHER||Mean Difference (Net)|1.0|||||TWO_SIDED|95.0|-6.0|7.99||||||Opioid abstinence between Weeks 10 to 38 (inclusive) was derived as his/her number of visits with negative assessments (defined as negative UDS and TLFB for opioid use) divided by 15. Under this derivation, any missed or skipped visits were counted as positive, in accordance with the composite intercurrent event strategy.||7.99|-6.00|
72579983|NCT04995029|144689343|OTHER||CMH Difference|2.73|||||TWO_SIDED|95.0|-4.98|10.43||This endpoint was summarized similar to the analysis for #4 above. The opioid abstinence percentage for an individual participant was derived as his/her number of visits with negative assessments divided by 5.|||CMH weighted treatment difference based on the CMH randomization stratified analysis using the Sato (1989) variance equation.|||10.43|-4.98|
72579984|NCT04995029|144689344|OTHER||CMH Difference|0.15|||||TWO_SIDED|95.0|-7.49|7.78|||||CMH weighted treatment difference based on the CMH randomization stratified analysis using the Sato (1989) variance equation.|||7.78|-7.49|
72579985|NCT04995029|144689345|OTHER||Mean Difference (Net)|1.49|||||TWO_SIDED|95.0|-4.8|7.78||||||||7.78|-4.80|
72579986|NCT04995029|144689346|OTHER||Mean Difference (Net)|-0.64|||||TWO_SIDED|95.0|-5.38|4.09||||||||4.09|-5.38|
72579987|NCT04995029|144689347|OTHER||Mean Difference (Net)|-1.37|||||TWO_SIDED|95.0|-9.0|6.25||||||||6.25|-9.00|
72579988|NCT04995029|144689353|OTHER||CMH Difference|1.54|||||TWO_SIDED|95.0|-7.56|10.65|||||CMH weighted treatment difference based on the CMH randomisation stratified analysis using the Sato (1989) variance equation.|||10.65|-7.56|
72579989|NCT04995029|144689354|OTHER||Cox Proportional Hazard|0.82|||||TWO_SIDED|95.0|0.65|1.03|||||Estimated using a Cox proportional hazard model, with treatment arm as a single covariate, stratified by the randomisation strata. Note that the estimation is impacted by last observed visit for the OLTP (including out-of-window visits).|||1.03|0.65|
72579990|NCT03915652|144689357|SUPERIORITY||Mean Difference (Final Values)|-0.93||||0.34|TWO_SIDED|95.0|-2.88|1.02|||t-test, 2 sided|Paired t-test||Waves 1 and 2 were combined and appointment nonadherence during the intervention was compared with the 12 months prior.||1.02|-2.88|0.34
72329498|NCT00443872|144184452|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.2|||<|0.05|TWO_SIDED|||||This analysis is for the motor section of the UPDRS|Wilcoxon (Mann-Whitney)|||||||<0.05
72411685|NCT00406029|144331705|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.2||||0.626|TWO_SIDED|95.0|-0.9|0.5|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.5|-0.9|0.626
72411686|NCT00406029|144331705|SUPERIORITY_OR_OTHER||Difference in LS Means|0.0||||0.925|TWO_SIDED|95.0|-0.8|0.7|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.7|-0.8|0.925
72411687|NCT00406029|144331705|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.1||||0.849|TWO_SIDED|95.0|-1.0|0.8|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.8|-1.0|0.849
72545499|NCT02661126|144620114|OTHER|GMR of AUC0-last in Moderate RI/Healthy Participants.|GMR of AUC0-last in Moderate RI/Healthy|1.91|||||TWO_SIDED|90.0|1.44|2.53||||||||2.53|1.44|
72329499|NCT00443872|144184453|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.2|||<|0.01|TWO_SIDED||||||t-test, 2 sided|||||||<0.01
72545500|NCT02661126|144620115|OTHER|GMR of AUC0-∞ in Moderate RI/Healthy Participants|GMR of AUC0-∞ in Moderate RI/Healthy|1.97|||||TWO_SIDED|90.0|1.48|2.63||||||||2.63|1.48|
72411688|NCT00406029|144331705|SUPERIORITY_OR_OTHER||Difference in LS Means|0.1||||0.755|TWO_SIDED|95.0|-0.7|1.0|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.0|-0.7|0.755
72545501|NCT02661126|144620116|OTHER|GMR of AUC0-24 in Moderate RI/Healthy Participants|GMR of AUC0-24 in Moderate RI/Healthy|1.96|||||TWO_SIDED|90.0|1.54|2.48||||||||2.48|1.54|
72545502|NCT02661126|144620117|OTHER|GMR of Cmax in Moderate RI/Healthy Participants|GMR of Cmax in Moderate RI/Healthy|1.7|||||TWO_SIDED|90.0|1.29|2.24||||||||2.24|1.29|
72579991|NCT03915652|144689358|SUPERIORITY||Mean Difference (Final Values)|-0.34||||0.34|TWO_SIDED|95.0|-1.08|0.39|||t-test, 2 sided|Paired t-test||Waves 1 and 2 were combined and emergency department visits and hospitalizations during the intervention was compared with the 12 months prior.||0.39|-1.08|0.34
72545503|NCT02661126|144620118|OTHER|GMR of C24 in Moderate RI/Healthy Participants|GMR of C24 in Moderate RI/Healthy|1.94|||||TWO_SIDED|90.0|1.47|2.57||||||||2.57|1.47|
72545504|NCT02661126|144620121|OTHER|GMR of AUC0-last in Moderate RI/Healthy Participants.|GMR of AUC0-last in Moderate RI/Healthy|1.33|||||TWO_SIDED|90.0|0.65|2.75||||||||2.75|0.65|
72545505|NCT02661126|144620122|OTHER|GMR of AUC0-∞ in Moderate RI/Healthy Participants|GMR of AUC0-∞ in Moderate RI/Healthy|1.59|||||TWO_SIDED|90.0|0.79|3.19||||||||3.19|0.79|
72545506|NCT02661126|144620123|OTHER|GMR of AUC0-24 in Moderate RI/Healthy Participants|GMR of AUC0-24 in Moderate RI/Healthy|1.15|||||TWO_SIDED|90.0|0.51|2.57||||||||2.57|0.51|
72545507|NCT02661126|144620124|OTHER|GMR of Cmax in Moderate RI/Healthy Participants|GMR of Cmax in Moderate RI/Healthy|1.23|||||TWO_SIDED|90.0|0.5|3.05||||||||3.05|0.50|
72545508|NCT02661126|144620125|OTHER|GMR of C24 in Moderate RI/Healthy Participants|GMR of C24 in Moderate RI/Healthy|1.28|||||TWO_SIDED|90.0|0.56|2.91||||||||2.91|0.56|
72579992|NCT03915652|144689359|SUPERIORITY||Mean Difference (Final Values)|0.59|||<|0.001|TWO_SIDED|95.0|0.45|0.73|||t-test, 1 sided|One sided t-test of percent of needs remaining from 100%.||Wave 1 and Wave 2 were combined and the quality metric at the end of the 12-month intervention was compared to the metric from the start of the intervention.||0.73|0.45|<0.001
72579993|NCT03915652|144689360|SUPERIORITY||Mean Difference (Final Values)|7.5||||0.51|TWO_SIDED|95.0|-19.8|34.8|||t-test, 2 sided|||||34.8|-19.8|0.51
72579994|NCT03915652|144689361|SUPERIORITY||Mean Difference (Final Values)|0.74||||0.17|TWO_SIDED|95.0|-0.43|1.92|||t-test, 2 sided|Paired t-test||Waves 1 and 2 combined, compared post to pre.||1.92|-0.43|0.17
72579995|NCT03915652|144689362|SUPERIORITY||Mean Difference (Final Values)|0.8||||0.72|TWO_SIDED|95.0|-4.92|6.52|||t-test, 2 sided|Paired t-test||Waves 1 and 2 combined, compared pre/post intervention||6.52|-4.92|0.72
72579996|NCT03915652|144689363|SUPERIORITY||Mean Difference (Final Values)|2.0||||0.5|TWO_SIDED|95.0|-6.22|10.22|||t-test, 2 sided|||Waves 1 and 2 are combined; pre/post survey analysis||10.22|-6.22|0.50
72579997|NCT03915652|144689364|SUPERIORITY||Mean Difference (Final Values)|3.77||||0.01|TWO_SIDED|95.0|1.06|6.47|||t-test, 2 sided|||Waves 1 and 2 combined; pre/post analysis||6.47|1.06|0.01
72545509|NCT02661126|144620130|OTHER|GMR of AUC0-last in Moderate RI/Healthy Participants.|GMR of AUC0-last in Moderate RI/Healthy|1.56|||||TWO_SIDED|90.0|1.19|2.05||||||||2.05|1.19|
72545510|NCT02661126|144620131|OTHER|GMR of AUC0-∞ in Moderate RI/Healthy Participants|GMR of AUC0-∞ in Moderate RI/Healthy|1.57|||||TWO_SIDED|90.0|1.2|2.05||||||||2.05|1.20|
72545511|NCT02661126|144620132|OTHER|GMR of AUC0-24 in Moderate RI/Healthy Participants|GMR of AUC0-24 in Moderate RI/Healthy|1.49|||||TWO_SIDED|90.0|1.13|1.98||||||||1.98|1.13|
72545512|NCT02661126|144620133|OTHER|GMR of Cmax in Moderate RI/Healthy Participants|GMR of Cmax in Moderate RI/Healthy|1.44|||||TWO_SIDED|90.0|1.05|1.98||||||||1.98|1.05|
72579998|NCT03915652|144689365|SUPERIORITY||Mean Difference (Final Values)|-0.14||||0.77|TWO_SIDED|95.0|-1.27|0.98|||t-test, 2 sided|Paired t-test||Waves 1 and 2 combined, pre/post test||0.98|-1.27|0.77
72579999|NCT03915652|144689366|SUPERIORITY||Mean Difference (Final Values)|2.14||||0.37|TWO_SIDED|95.0|-3.23|7.52|||t-test, 2 sided|Paired t-test||Waves 1 and 2 combined; pre/post analysis||7.52|-3.23|0.37
72329500|NCT00443872|144184454|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.8|||>|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||>0.05
72545513|NCT02661126|144620134|OTHER|GMR of C24 in Moderate RI/Healthy Participants|GMR of C24 in Moderate RI/Healthy|1.54|||||TWO_SIDED|90.0|1.15|2.07||||||||2.07|1.15|
72545514|NCT02917447|144620146|SUPERIORITY|||||||0.15||||||Omnibus test for difference in change from baseline in PCL by treatment group across the three post-treatment assessments, adjusted for rural/urban status and MST.|Mixed Models Analysis|Fixed effects were study assessment, group, the assessment by group interaction, and covariates. Participant was modeled as a random effect.||||||0.15
72545515|NCT02917447|144620147|SUPERIORITY|||||||0.049||||||Omnibus test for difference in change from baseline in outcome by treatment group across the three post-treatment assessments, adjusted for rural/urban status and MST.|Mixed Models Analysis|Fixed effects were study assessment, group, the assessment by group interaction, and covariates. Participant was modeled as a random effect.||||||.049
72545516|NCT02917447|144620148|SUPERIORITY|||||||0.92||||||Omnibus test for difference in change from baseline in outcome by treatment group across the three post-treatment assessments, adjusted for rural/urban status and MST.|Mixed Models Analysis|Fixed effects were study assessment, group, the assessment by group interaction, and covariates. Participant was modeled as a random effect.||||||0.92
72545517|NCT01267266|144620152|SUPERIORITY_OR_OTHER|||||||0.2|TWO_SIDED||||||Log Rank|||||||0.20
72545518|NCT01828255|144620187|OTHER||||||<|0.005|||||||t-test, 2 sided|||||||<0.005
72545519|NCT00789802|144620194|SUPERIORITY_OR_OTHER|||||||0.03|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.03
72545520|NCT00789802|144620194|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.02
72545521|NCT00268346|144620231|SUPERIORITY_OR_OTHER||percentage response|6.9|||<|0.05|TWO_SIDED|95.0|||||binomial test for a single proportion|||In patients with prior chemotherapy, \>25% response indicates efficacy and \<10% indicates lack of efficacy. In patients with no prior chemotherapy, \>45% response indicates efficacy and \<25% indicates lack of efficacy. Using a 5% significance level, the study was designed to have 80% power to test each hypothesis.||||<0.05
72545522|NCT02784106|144620267|SUPERIORITY||Difference in Proportion of Responders|0.1|||||TWO_SIDED|80.0|-0.07|0.25||||||||0.25|-0.07|
72545523|NCT02784106|144620268|SUPERIORITY||Difference in Mean Changes|-1.93|||||TWO_SIDED|80.0|-5.54|1.69||||||||1.69|-5.54|
72545524|NCT02784106|144620269|SUPERIORITY||Difference in Proportion of Responders|-0.04|||||TWO_SIDED|80.0|-0.13|0.06||||||Day 28||0.06|-0.13|
72580000|NCT01295112|144689374|SUPERIORITY|||||||2e-05|||||||Cochran-Mantel-Haenszel|||||||0.00002
72580001|NCT01295112|144689375|NON_INFERIORITY|Non-inferiority will be described by the 95% upper bound of the confidence interval on the difference in the improvement from baseline in BCVA|Mean Difference (Final Values)|2.51|STANDARD_DEVIATION|17.96||0.53|TWO_SIDED|90.0|-4.43|9.74||The p-value is assume superiority. The 95% upper confidence (upper end of the 90% Confidence interval) interval for the non-inferiority analysis is provided below.|t-test, 1 sided|||||9.74|-4.43|0.53
72545525|NCT02784106|144620269|SUPERIORITY||Difference in Proportion of Responders|-0.04|||||TWO_SIDED|80.0|-0.18|0.09||||||Day 56||0.09|-0.18|
72545526|NCT02784106|144620269|SUPERIORITY||Difference in Proportion of Responders|-0.01|||||TWO_SIDED|80.0|-0.15|0.12||||||Day 84||0.12|-0.15|
72580002|NCT03071692|144689376|SUPERIORITY||Hazard Ratio (HR)|1.03|||||TWO_SIDED|95.0|0.92|1.16||||||||1.16|0.92|
72545527|NCT02784106|144620270|SUPERIORITY||Difference in Proportion of Responders|0.06|||||TWO_SIDED|80.0|0.01|0.14||||||Day 28||0.14|0.01|
72545528|NCT02784106|144620270|SUPERIORITY||Difference in Proportion of Responders|0.03|||||TWO_SIDED|80.0|-0.05|0.11||||||Day 56||0.11|-0.05|
72545529|NCT02784106|144620270|SUPERIORITY||Difference in Proportion of Responders|-0.04|||||TWO_SIDED|80.0|-0.15|0.07||||||Day 84||0.07|-0.15|
72545530|NCT02784106|144620271|SUPERIORITY||Difference in Mean Changes|-1.4|||||TWO_SIDED|80.0|-5.37|2.58||||||||2.58|-5.37|
72545531|NCT02784106|144620272|SUPERIORITY||Difference in Mean Changes|-0.08|||||TWO_SIDED|80.0|-0.33|0.16||||||Day 28||0.16|-0.33|
72545532|NCT02784106|144620272|SUPERIORITY||Difference in Mean Changes|0.07|||||TWO_SIDED|80.0|-0.29|0.43||||||Day 84||0.43|-0.29|
72545533|NCT02784106|144620273|SUPERIORITY||Difference in Proportion of Participants|0.08|||||TWO_SIDED|80.0|-0.04|0.21||||||||0.21|-0.04|
72545534|NCT02784106|144620274|SUPERIORITY||Difference in Proportion of Participants|-0.04|||||TWO_SIDED|80.0|-0.13|0.06||||||||0.06|-0.13|
72545535|NCT02022007|144620329|SUPERIORITY_OR_OTHER|||||||0.007|||||||McNemar|||Study change from dysglycemia to normal glucose state||||.007
72545536|NCT02022007|144620330|SUPERIORITY_OR_OTHER|||||||0.02|||||||ANOVA|||This was a Subjects (SS)/Groups repeated measures design||||.02
72545537|NCT02022007|144620331|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|n||Pretreatment fasting glucose levels were compared with post-treatment levels||||<0.0001
72545538|NCT02022007|144620332|SUPERIORITY_OR_OTHER|||||||0.038|||||||ANOVA|||||||.038
72545539|NCT02022007|144620333|SUPERIORITY_OR_OTHER|||||||0.003|||||||ANOVA|||||||0.003
72545540|NCT02022007|144620334|SUPERIORITY_OR_OTHER|||||||0.025|||||||ANOVA|||||||.025
72545541|NCT02022007|144620335|SUPERIORITY_OR_OTHER|||||||0.006|||||||ANOVA|||||||0.006
72545542|NCT02022007|144620336|SUPERIORITY_OR_OTHER|||||||0.006|||||||ANOVA|||||||.006
72545543|NCT02022007|144620337|SUPERIORITY_OR_OTHER|||||||0.026|||||||ANOVA|||||||.026
72545544|NCT02022007|144620338|SUPERIORITY_OR_OTHER|||||||0.006|||||||ANOVA|||||||.006
72545545|NCT02022007|144620339|SUPERIORITY_OR_OTHER|||||||0.006|||||||ANOVA|||||||.006
72545546|NCT02022007|144620340|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Fisher Exact|||||||>0.05
72545547|NCT00617461|144620364|SUPERIORITY_OR_OTHER||Adjusted mean difference versus placebo|-0.29||||0.013|TWO_SIDED|90.0|-0.48|-0.1|||ANCOVA|An ANCOVA (repeated measures mixed model) with body mass index, baseline 24-hr average pain intensity, and grouped center as covariates was used.||||-0.10|-0.48|0.013
72545548|NCT00320593|144620405|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.28|||||TWO_SIDED|95.0|0.01|0.55|||ANCOVA|||The primary analysis was a comparison of treatment groups using an analysis of covariance (ANCOVA) model in which myopia at 3 years was adjusted for myopia at baseline and prior SVL wear. The sample size was computed to reach a 90% power and type I error rate of 5%, so that a difference in 3-year myopia progression between treatment groups would be detected if the true difference was at least 0.60 D, assuming a standard deviation of 0.85 D in each group and loss of follow up of 10%.||0.55|0.01|
72545549|NCT00320593|144620405|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.27|||||TWO_SIDED|95.0|0.02|0.53|||ANCOVA|||An adjusted analysis for the treatment group difference of change in spherical equivalent from baseline to 3 years was performed by including in an analysis of covariance (ANCOVA) model the following covariates in addition to baseline myopia and prior single vision lens wear, which are known to be related to myopia progression: age, sex, ethnicity, accommodative lag, and magnitude of near esophoria.||0.53|0.02|
72580003|NCT03071692|144689377|SUPERIORITY||Hazard Ratio (HR)|1.05|||||TWO_SIDED|95.0|0.92|1.2||||||||1.20|0.92|
72580004|NCT03071692|144689378|SUPERIORITY||Hazard Ratio (HR)|1.03|||||TWO_SIDED|95.0|0.89|1.18||||||||1.18|0.89|
72580005|NCT03071692|144689379|SUPERIORITY||Hazard Ratio (HR)|1.04|||||TWO_SIDED|95.0|0.93|1.16||||||||1.16|0.93|
72580006|NCT03071692|144689380|SUPERIORITY||Hazard Ratio (HR)|1.03|||||TWO_SIDED|95.0|0.93|1.13||||||||1.13|0.93|
72580007|NCT03071692|144689381|SUPERIORITY||Event Rate Ration|0.99|||||TWO_SIDED|95.0|0.87|1.13||||||||1.13|0.87|
72580008|NCT03071692|144689382|SUPERIORITY||Hazard Ratio (HR)|0.87|||||TWO_SIDED|95.0|0.69|1.09||||||||1.09|0.69|
72580009|NCT03071692|144689383|SUPERIORITY||Hazard Ratio (HR)|1.16|||||TWO_SIDED|95.0|0.95|1.41||||||||1.41|0.95|
72411689|NCT00406029|144331705|SUPERIORITY_OR_OTHER||Difference in LS Means|0.1||||0.863|TWO_SIDED|95.0|-0.8|0.9|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.9|-0.8|0.863
72580010|NCT03071692|144689384|SUPERIORITY||Hazard Ratio (HR)|0.9|||||TWO_SIDED|95.0|0.69|1.19||||||||1.19|0.69|
72580011|NCT03071692|144689385|SUPERIORITY||Hazard Ratio (HR)|0.98|||||TWO_SIDED|95.0|0.84|1.14||||||||1.14|0.84|
72580012|NCT03071692|144689386|SUPERIORITY||Hazard Ratio (HR)|1.04|||||TWO_SIDED|95.0|0.83|1.32||||||||1.32|0.83|
72580013|NCT03071692|144689387|SUPERIORITY||Hazard Ratio (HR)|0.97|||||TWO_SIDED|95.0|0.75|1.26||||||TT Variant||1.26|0.75|
72580014|NCT03071692|144689387|SUPERIORITY||Hazard Ratio (HR)|1.19|||||TWO_SIDED|95.0|0.96|1.47||||||CT Variant||1.47|0.96|
72580015|NCT03071692|144689387|SUPERIORITY||Hazard Ratio (HR)|0.98|||||TWO_SIDED|95.0|0.69|1.39||||||CC Variant||1.39|0.69|
72580016|NCT03071692|144689388|SUPERIORITY|||||||0.13496|||||||ANCOVA|||||||0.13496
72580017|NCT03071692|144689389|SUPERIORITY||||||<|0.001|||||||ANCOVA|||||||<0.001
72580018|NCT03071692|144689390|SUPERIORITY||||||<|0.001|||||||ANCOVA|||||||<0.001
72580019|NCT03071692|144689391|SUPERIORITY|||||||0.96689|||||||ANCOVA|||||||0.96689
72580020|NCT03071692|144689392|SUPERIORITY||||||<|0.001|||||||ANCOVA|||||||<0.001
72580021|NCT03071692|144689393|SUPERIORITY|||||||0.09178|||||||ANCOVA|||||||0.09178
72580022|NCT03071692|144689394|SUPERIORITY||||||<|0.001|||||||ANCOVA|||||||<0.001
72580023|NCT03071692|144689395|SUPERIORITY||||||<|0.001|||||||ANCOVA|||||||<0.001
72580024|NCT03071692|144689396|SUPERIORITY||||||<|0.001|||||||ANCOVA|||||||<0.001
72580025|NCT00970593|144689405|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.75|STANDARD_ERROR_OF_MEAN|0.526|||TWO_SIDED|95.0|-1.79|0.29||||||The Mixed model used fixed effects of treatment, study day and treatment by study day interaction.||0.29|-1.79|
72580026|NCT00970593|144689405|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.9|STANDARD_ERROR_OF_MEAN|0.543|||TWO_SIDED|95.0|-2.98|-0.83||||||The Mixed model used fixed effects of treatment, study day and treatment by study day interaction.||-0.83|-2.98|
72580027|NCT00970593|144689405|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-2.15|STANDARD_ERROR_OF_MEAN|0.458|||TWO_SIDED|95.0|-3.06|-1.24||||||The Mixed model used fixed effects of treatment, study day and treatment by study day interaction.||-1.24|-3.06|
72411690|NCT00406029|144331705|SUPERIORITY_OR_OTHER||Difference in LS Means|0.3||||0.477|TWO_SIDED|95.0|-0.5|1.1|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.1|-0.5|0.477
72580028|NCT00970593|144689406|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-2.37|STANDARD_ERROR_OF_MEAN|0.58|||TWO_SIDED|95.0|-3.52|-1.22||||||The Mixed model used fixed effects of treatment, study day and treatment by study day interaction.||-1.22|-3.52|
72580029|NCT00970593|144689406|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-3.18|STANDARD_ERROR_OF_MEAN|0.495|||TWO_SIDED|95.0|-4.16|-2.2||||||The Mixed model used fixed effects of treatment, study day and treatment by study day interaction.||-2.20|-4.16|
72329501|NCT00443872|144184455|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.6|||>|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||>0.05
72580030|NCT00970593|144689406|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-3.14|STANDARD_ERROR_OF_MEAN|0.437|||TWO_SIDED|95.0|-4.01|-2.28||||||The Mixed model used fixed effects of treatment, study day and treatment by study day interaction.||-2.28|-4.01|
72580031|NCT00629018|144689414|SUPERIORITY_OR_OTHER|||||||0.01||95.0|||||Log Rank|||The minimal sample size for the study was calculated using a pre-specified power of 90% and P value of 0.05.||||0.01
72580032|NCT02045446|144689420|SUPERIORITY||Hazard Ratio (HR)|0.304||||0.01|TWO_SIDED|95.0|0.113|0.815|||Log Rank|||||0.815|0.113|.01
72580033|NCT04090125|144689426|SUPERIORITY||Mean Difference (Final Values)|-0.23||||0.485|TWO_SIDED|95.0|-0.9|0.43|||Mixed Models Analysis|||||0.43|-0.90|0.485
72580034|NCT04090125|144689427|SUPERIORITY||Mean Difference (Final Values)|-0.53||||0.0887|TWO_SIDED|95.0|-1.13|0.08|||Mixed Models Analysis|||||0.08|-1.13|0.0887
72580035|NCT04090125|144689428|SUPERIORITY||Mean Difference (Final Values)|0.06||||0.296|TWO_SIDED|95.0|-0.05|0.13|||Mixed Models Analysis|||||0.13|-0.05|0.296
72580036|NCT04090125|144689429|SUPERIORITY||Mean Difference (Final Values)|-0.07||||0.094|TWO_SIDED|95.0|-0.15|0.01|||Mixed Models Analysis|||||0.01|-0.15|0.094
72580037|NCT04090125|144689430|SUPERIORITY||Mean Difference (Final Values)|3.85||||0.11|TWO_SIDED|95.0|-0.91|8.62|||Mixed Models Analysis|||||8.62|-0.91|0.11
72580038|NCT04090125|144689431|SUPERIORITY||Mean Difference (Final Values)|1.74||||0.55|TWO_SIDED|95.0|-4.1|7.59|||Mixed Models Analysis|||||7.59|-4.10|0.55
72580039|NCT04090125|144689432|SUPERIORITY||Mean Difference (Final Values)|-0.15||||0.134|TWO_SIDED|95.0|-0.34|0.05|||Mixed Models Analysis|||||0.05|-0.34|0.134
72580040|NCT04090125|144689433|SUPERIORITY||Mean Difference (Final Values)|-0.17||||0.09|TWO_SIDED|95.0|-0.38|0.03|||Mixed Models Analysis|||||0.03|-0.38|0.09
72580041|NCT04090125|144689434|SUPERIORITY||Mean Difference (Final Values)|-0.06||||0.25|TWO_SIDED|95.0|-0.16|0.04|||Mixed Models Analysis|||||0.04|-0.16|0.25
72580042|NCT04090125|144689435|SUPERIORITY||Mean Difference (Final Values)|-0.09||||0.16|TWO_SIDED|95.0|-0.22|0.04|||Mixed Models Analysis|||||0.04|-0.22|0.16
72580043|NCT04090125|144689436|SUPERIORITY||Mean Difference (Final Values)|21.36||||0.167|TWO_SIDED|95.0|-9.29|52.02|||Mixed Models Analysis|||||52.02|-9.29|0.167
72580044|NCT04090125|144689437|SUPERIORITY||Mean Difference (Final Values)|25.15||||0.189|TWO_SIDED|95.0|-12.85|63.14|||Mixed Models Analysis|||||63.14|-12.85|0.189
72580045|NCT04090125|144689442|SUPERIORITY||Mean Difference (Final Values)|2.51||||0.42|TWO_SIDED|95.0|-3.65|8.67|||Mixed Models Analysis|||Pain subscale||8.67|-3.65|0.42
72580046|NCT04090125|144689442|SUPERIORITY||Mean Difference (Final Values)|1.14||||0.76|TWO_SIDED|95.0|-6.29|8.57|||Mixed Models Analysis|||Symptoms subscale||8.57|-6.29|0.76
72580047|NCT04090125|144689442|SUPERIORITY||Mean Difference (Final Values)|-3.54||||0.46|TWO_SIDED|95.0|-13.2|6.12|||Mixed Models Analysis|||Quality of life subscale||6.12|-13.20|0.46
72329502|NCT00443872|144184456|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.4|||<|0.05|TWO_SIDED||||||t-test, 2 sided|||||||<0.05
72580048|NCT04090125|144689442|SUPERIORITY||Mean Difference (Final Values)|2.54||||0.22|TWO_SIDED|95.0|-1.61|6.69|||Mixed Models Analysis|||Function in daily life||6.69|-1.61|0.22
72580049|NCT04090125|144689443|SUPERIORITY||Mean Difference (Final Values)|1.43||||0.65|TWO_SIDED|95.0|-4.98|7.85|||Mixed Models Analysis|||Pain subscale||7.85|-4.98|0.65
72580050|NCT04090125|144689443|SUPERIORITY||Mean Difference (Final Values)|3.95||||0.32|TWO_SIDED|95.0|-3.93|11.83|||Mixed Models Analysis|||Symptoms subscale||11.83|-3.93|0.32
72580051|NCT04090125|144689443|SUPERIORITY||Mean Difference (Final Values)|1.64||||0.77|TWO_SIDED|95.0|-9.61|12.89|||Mixed Models Analysis|||Quality of life||12.89|-9.61|0.77
72580052|NCT04090125|144689443|SUPERIORITY||Mean Difference (Final Values)|3.25||||0.19|TWO_SIDED|95.0|-1.67|8.17|||Mixed Models Analysis|||Function in daily life||8.17|-1.67|0.19
72580053|NCT04090125|144689444|SUPERIORITY||Mean Difference (Final Values)|-1.95||||0.191|TWO_SIDED|95.0|-4.92|1.01|||Mixed Models Analysis|||||1.01|-4.92|0.191
72580054|NCT04090125|144689445|SUPERIORITY||Mean Difference (Final Values)|-5.45||||0.0004|TWO_SIDED|95.0|-8.28|-2.62|||Mixed Models Analysis|||||-2.62|-8.28|0.0004
72580055|NCT01342081|144689446|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.7|||<|0.001|TWO_SIDED|95.0|-2.1|-1.3|||ANCOVA|||||-1.3|-2.1|< 0.001
72580056|NCT01342081|144689446|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin of 1.5 mmHg was used. Non-inferiority was claimed if the upper limit of the confidence interval of the difference is 1.5 mmHg or less.|Mean Difference (Final Values)|-0.3|||||TWO_SIDED|95.0|-0.7|0.1||||||Non-inferiority was evaluated after superiority to tafluprost was confirmed.||0.1|-0.7|
72580057|NCT01608100|144689459|SUPERIORITY_OR_OTHER||Area Under the Curve|0.9326|||||TWO_SIDED|95.0|0.9048|0.9604||||||Time point: 0-2 hours||0.9604|0.9048|
72580058|NCT01608100|144689459|SUPERIORITY_OR_OTHER||Area Under the Curve|0.9431|||||TWO_SIDED|95.0|0.9081|0.9782||||||Time point: 2-4 hours||0.9782|0.9081|
72545550|NCT00320593|144620408|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.14|||||TWO_SIDED|95.0|-0.005|0.28|||ANCOVA|||A secondary analysis was conducted to assess the treatment effect on myopia at the interim time point of 1 year, using an analysis of covariance (ANCOVA) model for the treatment group difference of change in spherical equivalent refractive error from baseline to 1 year, in which myopia at 1 year was adjusted for myopia at baseline and prior single vision lenses wear. Only complete cases (cases in which both baseline and 1 year values were known) were included.||0.28|-0.005|
72545551|NCT00320593|144620409|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.23|||||TWO_SIDED|95.0|0.02|0.45|||ANCOVA|||A secondary analysis was conducted to assess the treatment effect on myopia at the interim time point of 2 years, using an analysis of covariance (ANCOVA) model for the treatment group difference of change in spherical equivalent refractive error from baseline to 2 years, in which myopia at 2 years was adjusted for myopia at baseline and prior single vision lenses wear. Only complete cases (cases in which both baseline and 2 year values were known) were included.||0.45|0.02|
72545552|NCT00457665|144620411|SUPERIORITY|||||||0.94|||||||Mixed Models Analysis|||||||0.94
72545553|NCT01851590|144620435|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|||||Proportions and 95% confidence intervals (CIs) were calculated for negative KOH staining, negative cultures, and a combination of these at 4- and 10-month time points. Cochran-Mantel-Haenszel and χ2-tests were used to analyse efficacy criteria.|Cochran-Mantel-Haenszel|||The sample size was estimated according to complete mycological cure at 10 months. Estimation was based on the design of a binary-outcome head-to-head superiority trial. Orally administered terbinafine treatment was considered the active control. Approximately 25 patients / arm were required to have 80% power (β=0.2) at a two-sided α=0.05 significance level to detect a decrease in primary outcome from 50% in the terbinafine arm to 15% in the amorolfine or resin lacquer treatment arms.||||<0.05
72545554|NCT01851590|144620436|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|||||Differences between quantitative data were assessed with one-way analysis of variances, and pairwise comparisons were performed with Bonferroni's post hoc test.|ANOVA|||||||<0.05
72545555|NCT01851590|144620437|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|||||Differences between quantitative data were assessed with one-way analysis of variances, and pairwise comparisons were performed with Bonferroni's post hoc test.|ANOVA|||||||<0.05
72580059|NCT01608100|144689459|SUPERIORITY_OR_OTHER||Area Under the Curve|0.9503|||||TWO_SIDED|95.0|0.9419|0.9857||||||Time point: 4-9 hours||0.9857|0.9419|
72580060|NCT01608100|144689459|SUPERIORITY_OR_OTHER||Area Under the Curve|0.9197|||||TWO_SIDED|95.0|0.8914|0.948||||||Time point: 0-2 hours||0.9480|0.8914|
72545556|NCT01851590|144620438|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|||||Differences between quantitative data were assessed with one-way analysis of variances, and pairwise comparisons were performed with Bonferroni's post hoc test.|ANOVA|||||||<0.05
72545557|NCT01851590|144620439|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|||||Qualitative data are expressed as frequencies and percentages, and differences between parallel groups were compared with the χ2-test or Fisher's exact test, as appropriate.|Chi-squared|||||||<0.05
72545558|NCT01714505|144620440|SUPERIORITY_OR_OTHER|||||||0.003|||||||t-test, 1 sided|Paired t-tests: compare LBGI, carbohydrates for hypoglycemia treatment, % of time in range and average BG on CLC vs OL.||||||0.003
72545559|NCT01714505|144620441|SUPERIORITY_OR_OTHER||||||>|0.1|||||||t-test, 1 sided|||||||>0.1
72545560|NCT01714505|144620442|SUPERIORITY_OR_OTHER|||||||0.02|||||||Wilcoxon (Mann-Whitney)|||||||0.02
72580061|NCT01608100|144689459|SUPERIORITY_OR_OTHER||Area Under the Curve|0.9349|||||TWO_SIDED|95.0|0.8986|0.9712||||||Time point: 2-4 hours||0.9712|0.8986|
72580062|NCT01608100|144689459|SUPERIORITY_OR_OTHER||Area Under the Curve|0.9498|||||TWO_SIDED|95.0|0.919|0.9805||||||Time point: 4-9 hours||0.9805|0.9190|
72580063|NCT01608100|144689459|SUPERIORITY_OR_OTHER||Area Under the Curve|0.9412|||||TWO_SIDED|95.0|0.9102|0.9722||||||Time point: 0-2 hours||0.9722|0.9102|
72580064|NCT01608100|144689459|SUPERIORITY_OR_OTHER||Area Under the Curve|0.9419|||||TWO_SIDED|95.0|0.9041|0.9796||||||Time point: 2-4 hours||0.9796|0.9041|
72545561|NCT01832090|144620475|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
72545562|NCT01832090|144620476|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Fisher Exact|||||||<0.0001
72545563|NCT01832090|144620477|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Fisher Exact|||||||<0.0001
72545564|NCT01832090|144620478|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
72545565|NCT01832090|144620479|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Fisher Exact|||||||>0.05
72545566|NCT01832090|144620480|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Fisher Exact|||||||>0.05
72580065|NCT01608100|144689459|SUPERIORITY_OR_OTHER||Area Under the Curve|0.9449|||||TWO_SIDED|95.0|0.9046|0.9852||||||Time point: 4-9 hours||0.9852|0.9046|
72580066|NCT01608100|144689460|SUPERIORITY_OR_OTHER||Proportion Percentage|7.0||||0.0004|TWO_SIDED||||||Log Rank||Proportion percentage for subjects with ARCHITECT Troponin value greater than the cutoff|Kaplan-Meier||||0.0004
72545567|NCT01832090|144620483|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
72545568|NCT01832090|144620484|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
72545569|NCT01211769|144620495|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA|||TIME COMPARISON||||<0.001
72545570|NCT01211769|144620495|SUPERIORITY_OR_OTHER||Variance (F)|0.71||||0.69||95.0|||||ANOVA|||GROUP COMPARISON||||0.69
72545571|NCT01211769|144620496|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA|||TIME COMPARISON||||<0.001
72580067|NCT01608100|144689460|SUPERIORITY_OR_OTHER||Proportion Percentage|2.31||||0.0004|TWO_SIDED||||||Log Rank||Proportion percentage for subjects with ARCHITECT Troponin value less than or equal to the cutoff|Kaplan-Meier||||0.0004
72580068|NCT01608100|144689460|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|3.09||||0.0011|TWO_SIDED|95.0|1.59|5.95||Likelihood Ratio|Regression, Cox|||Hazard Ratio||5.95|1.59|0.0011
72580069|NCT01608100|144689460|SUPERIORITY_OR_OTHER||Proportion Percentage|12.76|||<|0.0001|TWO_SIDED||||||Log Rank||Proportion percentage for subjects with ARCHITECT Troponin value greater than the cutoff|Kaplan-Meier||||<0.0001
72580070|NCT01608100|144689460|SUPERIORITY_OR_OTHER||Proportion Percentage|3.65|||<|0.0001|TWO_SIDED||||||Log Rank||Proportion percentage for subjects with ARCHITECT Troponin value less than or equal to the cutoff|Kaplan-Meier||||<0.0001
72580071|NCT01608100|144689460|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|3.65|||<|0.0001|TWO_SIDED|95.0|2.21|6.05||Likelihood Ratio|Regression, Cox|||Hazard Ratio||6.05|2.21|<0.0001
72580072|NCT01608100|144689460|SUPERIORITY_OR_OTHER||Proportion Percentage|7.17|||<|0.0001|TWO_SIDED||||||Log Rank||Proportion percentage for subjects with ARCHITECT Troponin value greater than the cutoff|Kaplan-Meier||||<0.0001
72329503|NCT00135330|144184457|SUPERIORITY_OR_OTHER|||||||0.282||95.0|||||ANCOVA|||The ratio of the ASI-iAUC at Week 20 to that at baseline was compared between the treatment groups.||||0.282
72545572|NCT01211769|144620496|SUPERIORITY_OR_OTHER||Variance (F)|0.73||||0.53||95.0|||||ANOVA|||GROUP COMPARISON||||0.53
72545573|NCT01211769|144620497|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA|||TIME COMPARISON||||<0.001
72545574|NCT01211769|144620497|SUPERIORITY_OR_OTHER||Variance (F)|1.08||||0.37||95.0|||||ANOVA|||GROUP COMPARISON||||0.37
72545575|NCT00926289|144620510|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.5|||<|0.0001||95.0|-10.6|-6.4|||ANCOVA|Fixed effects of treatment, week, treatment-by-week interaction, country with the continuous covariates of baseline and baseline-by-week interaction||T80+HCTZ25 versus T80 monotherapy||-6.4|-10.6|<0.0001
72545576|NCT00926289|144620511|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.3|||<|0.0001||95.0|-9.3|-5.2|||ANCOVA|Fixed effects of treatment, week, treatment-by-week interaction, country with the continuous covariates of baseline and baseline-by-week interaction||T80+HCTZ25 versus T80 monotherapy||-5.2|-9.3|<0.0001
72545577|NCT00926289|144620512|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.8|||<|0.0001||95.0|-8.8|-4.7|||ANCOVA|Fixed effects of treatment, week, treatment-by-week interaction, country with the continuous covariates of baseline and baseline-by-week interaction||T80+HCTZ25 versus T80 monotherapy||-4.7|-8.8|<0.0001
72545578|NCT00926289|144620513|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.2|||<|0.0001||95.0|-4.5|-1.9|||ANCOVA|Fixed effects of treatment, week, treatment-by-week interaction, country with the continuous covariates of baseline and baseline-by-week interaction||T80+HCTZ25 versus T80 monotherapy||-1.9|-4.5|<0.0001
72545579|NCT00926289|144620514|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.36|||<|0.0001||95.0|1.74|3.21|||Regression, Logistic|Adjustment for continuous covariate of baseline, treatment and country as fixed effects.||T80+HCTZ25 versus T80 monotherapy||3.21|1.74|<0.0001
72580073|NCT01608100|144689460|SUPERIORITY_OR_OTHER||Proportion Percentage|2.07|||<|0.0001|TWO_SIDED||||||Log Rank||Proportion percentage for subjects with ARCHITECT Troponin value less than or equal to the cutoff|Kaplan-Meier||||<0.0001
72580074|NCT01608100|144689460|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|3.54||||0.0002|TWO_SIDED|95.0|1.84|6.87||Likelihood Ratio|Regression, Cox|||Hazard Ratio||6.87|1.84|0.0002
72545580|NCT00926289|144620515|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.3|||<|0.0001||95.0|1.7|3.12|||Regression, Logistic|Adjustment for continuous covariate of baseline, treatment and country as fixed effects.||T80+HCTZ25 versus T80 monotherapy||3.12|1.70|<0.0001
72545581|NCT00926289|144620516|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.19|||<|0.0001||95.0|1.6|3.01|||Regression, Logistic|Adjustment for continuous covariate of baseline, treatment and country as fixed effects.||T80+HCTZ25 versus T80 monotherapy||3.01|1.60|<0.0001
72545582|NCT00926289|144620517|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.0|||<|0.0001||95.0|1.46|2.73|||Regression, Logistic|Adjustment for continuous covariate of baseline, treatment and country as fixed effects.||T80+HCTZ25 versus T80 monotherapy||2.73|1.46|<0.0001
72545583|NCT00926289|144620518|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.02|||<|0.0001||95.0|1.48|2.76|||Regression, Logistic|Adjustment for continuous covariate of baseline, treatment and country as fixed effects.||T80+HCTZ25 versus T80 monotherapy||2.76|1.48|<0.0001
72545584|NCT00926289|144620519|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.74||||0.0005||95.0|1.28|2.37|||Regression, Logistic|Adjustment for continuous covariate of baseline and fixed effect country||T80+HCTZ25 versus T80 monotherapy||2.37|1.28|0.0005
72545585|NCT00926289|144620520|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.39|||<|0.0001||95.0|1.76|3.26|||Regression, Logistic|Adjustment for continuous covariate of baseline (SBP), treatment and country as fixed effects.||T80+HCTZ25 versus T80 monotherapy||3.26|1.76|<0.0001
72545586|NCT00926289|144620521|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.42|||<|0.0001||95.0|1.78|3.29|||Regression, Logistic|Adjustment for continuous covariate of baseline (DBP), treatment and country as fixed effects.||T80+HCTZ25 versus T80 monotherapy||3.29|1.78|<0.0001
72580075|NCT01608100|144689460|SUPERIORITY_OR_OTHER||Proportion Percentage|12.83|||<|0.0001|TWO_SIDED||||||Log Rank||Proportion percentage for subjects with ARCHITECT Troponin value greater than the cutoff|Kaplan-Meier||||<0.0001
72580076|NCT01608100|144689460|SUPERIORITY_OR_OTHER||Proportion Percentage|3.66|||<|0.0001|TWO_SIDED||||||Log Rank||Proportion percentage for subjects with ARCHITECT Troponin value less than or equal to the cutoff|Kaplan-Meier||||<0.0001
72329504|NCT00135330|144184458|SUPERIORITY_OR_OTHER|||||||0.004||95.0|||||ANCOVA|||||||0.004
72545587|NCT00926289|144620522|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.62|||<|0.0001||95.0|1.7|4.04|||Regression, Logistic|Adjustment for continuous covariate of baseline, treatment and country as fixed effects.||T80+HCTZ25 versus T80 monotherapy||4.04|1.70|<0.0001
72545588|NCT00926289|144620523|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.23|||<|0.0001||95.0|1.57|3.16|||Regression, Logistic|Adjustment for continuous covariate of baseline, treatment and country as fixed effects.||T80+HCTZ25 versus T80 monotherapy||3.16|1.57|<0.0001
72545589|NCT00926289|144620524|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Van Elteren test stratified for country|||T80+HCTZ25 versus T80 monotherapy||||<0.0001
72545590|NCT00634283|144620551|SUPERIORITY|||||||0.55|||||||t-test, 2 sided|||||||0.55
72580077|NCT01608100|144689460|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|3.68|||<|0.0001|TWO_SIDED|95.0|2.25|6.05||Likelihood Ratio|Regression, Cox|||Hazard Ratio||6.05|2.25|<0.0001
72580078|NCT01608100|144689460|SUPERIORITY_OR_OTHER||Proportion Percentage|6.07||||0.002|TWO_SIDED||||||Log Rank||Proportion percentage for subjects with ARCHITECT Troponin value greater than the cutoff|Kaplan-Meier||||0.0020
72580079|NCT01608100|144689460|SUPERIORITY_OR_OTHER||Proportion Percentage|2.09||||0.002|TWO_SIDED||||||Log Rank||Proportion percentage for subjects with ARCHITECT Troponin value less than or equal to the cutoff|Kaplan-Meier||||0.0020
72580080|NCT01608100|144689460|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.95||||0.005|TWO_SIDED|95.0|1.41|6.05||Likelihood Ratio|Regression, Cox|||Hazard Ratio||6.05|1.41|0.0050
72411691|NCT00406029|144331705|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.3||||0.432|TWO_SIDED|95.0|-1.0|0.4|||ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.4|-1.0|0.432
72411692|NCT00406029|144331705|SUPERIORITY_OR_OTHER||Difference in LS Means|0.0||||0.909|TWO_SIDED|95.0|-0.8|0.7|||ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.7|-0.8|0.909
72411693|NCT00406029|144331705|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.1||||0.812|TWO_SIDED|95.0|-0.8|0.7|||ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.7|-0.8|0.812
72411694|NCT00406029|144331705|SUPERIORITY_OR_OTHER||Difference in LS Means|0.2||||0.54|TWO_SIDED|95.0|-0.5|1.0|||ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.0|-0.5|0.540
72411695|NCT00406029|144331706|SUPERIORITY_OR_OTHER||Difference in LS Means|0.1||||0.829|TWO_SIDED|95.0|-0.7|0.9|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.9|-0.7|0.829
72411696|NCT00406029|144331706|SUPERIORITY_OR_OTHER||Difference in LS Means|0.8||||0.042|TWO_SIDED|95.0|0.0|1.6|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.6|0.0|0.042
72411697|NCT00406029|144331706|SUPERIORITY_OR_OTHER||Difference in LS Means|0.5||||0.204|TWO_SIDED|95.0|-0.3|1.4|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.4|-0.3|0.204
72411698|NCT00406029|144331706|SUPERIORITY_OR_OTHER||Difference in LS Means|0.9||||0.035|TWO_SIDED|95.0|0.1|1.6|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.6|0.1|0.035
72411699|NCT00406029|144331706|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.2||||0.696|TWO_SIDED|94.0|-1.2|0.8|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.8|-1.2|0.696
72545591|NCT00634283|144620551|SUPERIORITY|||||||0.32||||||The a priori threshold was set at 0.05, 2-tailed, without adjustment for multiple comparisons.|t-test, 2 sided|||Change in PFC over the one-week placebo lead-in period was compared between antidepressant-experienced and antidepressant-naive groups using a between groups t-test.|"Group differences in PFC changes over time during administration of venlafaxine were assessed using mixed-model analysis.~we compared brain functional changes over the course of venlafaxine treatment between antidepressant-experienced and antidepressant-naïve subjects using linear mixed model analysis (random intercept model) conducted using full maximum likelihood estimation (MLE). Changes in PFC were calculated from the end of placebo lead-in to 48 hours, and 1, 2, and 4 weeks, yielding a within-group factor of time with four levels. We employed a first-order autoregressive covariance structure to reflect our assumption that PFC measurements closer together in time would be more highly correlated."|||0.32
72545592|NCT01151813|144620583|SUPERIORITY_OR_OTHER_LEGACY|||||||0.02|||||||t-test, 2 sided|||||||.02
72329505|NCT00135330|144184459|SUPERIORITY_OR_OTHER|||||||0.308||95.0|||||ANCOVA|||||||0.308
72411700|NCT00406029|144331706|SUPERIORITY_OR_OTHER||Difference in LS Means|0.2||||0.625|TWO_SIDED|95.0|-0.7|1.2|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.2|-0.7|0.625
72545593|NCT01151813|144620584|SUPERIORITY_OR_OTHER_LEGACY|||||||0.03|||||||t-test, 2 sided|||||||0.03
72545594|NCT01151813|144620585|SUPERIORITY_OR_OTHER_LEGACY|||||||0.03|||||||t-test, 2 sided|||||||0.03
72580081|NCT01608100|144689460|SUPERIORITY_OR_OTHER||Proportion Percentage|12.15|||<|0.0001|TWO_SIDED||||||Log Rank||Proportion percentage for subjects with ARCHITECT Troponin value greater than the cutoff|Kaplan-Meier||||<0.0001
72411701|NCT00406029|144331706|SUPERIORITY_OR_OTHER||Difference in LS Means|0.4||||0.478|TWO_SIDED|95.0|-0.6|1.3|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.3|-0.6|0.478
72411702|NCT00406029|144331706|SUPERIORITY_OR_OTHER||Difference in LS Means|0.4||||0.38|TWO_SIDED|95.0|-0.5|1.4|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.4|-0.5|0.380
72411703|NCT00406029|144331706|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.1||||0.925|TWO_SIDED|95.0|-1.2|1.1|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.1|-1.2|0.925
72411704|NCT00406029|144331706|SUPERIORITY_OR_OTHER||Difference in LS Means|0.6||||0.285|TWO_SIDED|95.0|-0.5|1.7|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.7|-0.5|0.285
72545595|NCT01151813|144620586|SUPERIORITY_OR_OTHER_LEGACY|||||||0.04|||||||t-test, 2 sided|||||||0.04
72545596|NCT01144663|144620592|NON_INFERIORITY|Indication of non-inferiority of Nimenrix 3 Group compared to Menjugate Group is a lower limit of the 95% CI of the group difference greater than or equal to the predefined clinical limits of -5%.|Difference in percentage|0.01|||||TWO_SIDED|95.0|-1.17|1.2||||||To demonstrate the non-inferiority of the Nimenrix 3 Group compared to the Menjugate Group, two-sided standardized asymptotic 95% CI (confidence interval) for the groups difference \[Nimenrix 3 Group minus Menjugate Group\] in the percentages of subjects with bactericidal vaccine response to MenC was computed.||1.2|-1.17|
72545597|NCT01144663|144620592|NON_INFERIORITY|Indication of non-inferiority of Nimenrix 3 Group compared to Menjugate Group is a lower limit of the 95% CI of the group difference greater than or equal to the predefined clinical limits of -5%.|Difference in percenttage|-0.43|||||TWO_SIDED|95.0|-1.57|0.4||||||To demonstrate the non-inferiority of the Nimenrix 3 Group compared to the NeisVac-C Group, two-sided standardized asymptotic 95% CI for the groups difference \[Nimenrix 3 Group minus NeisVac-C Group\] in the percentages of subjects with bactericidal vaccine response to MenC was computed.||0.4|-1.57|
72545598|NCT01144663|144620592|NON_INFERIORITY|Indication of non-inferiority of Nimenrix 3 Group compared to Menjugate Group is a lower limit of the 95% CI of the group difference greater than or equal to the predefined clinical limits of -5%.|Difference in percentage|-0.88|||||TWO_SIDED|95.0|-2.45|0.43||||||To demonstrate the non-inferiority of the Nimenrix 2 Group compared to Menjugate Group, two-sided standardized asymptotic 95% CI for the groups difference \[Nimenrix 2 Group minus Menjugate Group\] in the percentages of subjects with bactericidal vaccine response to MenC was computed.||0.43|-2.45|
72545599|NCT01144663|144620592|NON_INFERIORITY|Indication of non-inferiority of Nimenrix 3 Group compared to Menjugate Group is a lower limit of the 95% CI of the group difference greater than or equal to the predefined clinical limits of -5%.|Difference in percentage|-1.32|||||TWO_SIDED|95.0|-2.84|-0.48||||||To demonstrate the non-inferiority of the Nimenrix 2 Group compared to NeisVac-C Group, two-sided standardized asymptotic 95% CI for the groups difference \[Nimenrix 2 Group minus NeisVac-C Group\] in the percentages of subjects with bactericidal vaccine response to MenC was computed.||-0.48|-2.84|
72545600|NCT03081767|144620640|OTHER||||||<|1e-07||||||Actual P-Value = 3.89597E-42. A P-value of \<0.05 was considered significant.|t-test, 2 sided|||||||<0.0000001
72545601|NCT01335477|144620641|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|93.73|STANDARD_ERROR_OF_MEAN|24.907||0.0002||95.0|44.78|142.68||The objective of this trial was to assess the superiority of nintedanib 150 mg bid compared to placebo on the annual rate of decline in FVC.|Random coefficient regression|The Roger-Kenward approximation was used to estimate denominators degrees of freedom.|"Within-patient errors are modelled by an Unstructured variance-covariance matrix.~Inter-individual variability is modelled by a Variance-components variance-covariance matrix.~Nintedanib 150 mg bid versus Placebo."|"Random coefficient regression with fixed effects for treatment, gender, age, height and random effect of patient specific intercept and time.~A hierarchical procedure was used in order to demonstrate the superiority of nintedanib over placebo for one primary and two key secondary endpoints.~The consecutive steps of the hierarchy were only considered if the previous step was significant at the one-sided 2.5% level and the results were in favour of nintedanib."||142.68|44.78|0.0002
72545602|NCT01335477|144620642|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.69|STANDARD_ERROR_OF_MEAN|1.151||0.0197||95.0|-4.95|-0.43|||Mixed Models Analysis||"Within-patient errors are modelled by compound symmetry covariance matrix.~Nintedanib 150 mg bid versus Placebo."|Mixed Model for Repeated Measures (MMRM), with fixed effects for treatment, visit, treatment-by-visit, baseline SGRQ Total score, baseline SGRQ Total score-by-visit and random effect for patient.||-0.43|-4.95|0.0197
72580082|NCT01608100|144689460|SUPERIORITY_OR_OTHER||Proportion Percentage|3.57|||<|0.0001|TWO_SIDED||||||Log Rank||Proportion percentage for subjects with ARCHITECT Troponin value less than or equal to the cutoff|Kaplan-Meier||||<0.0001
72580083|NCT01608100|144689460|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|3.55|||<|0.0001|TWO_SIDED|95.0|2.08|6.03||Likelihood Ratio|Regression, Cox|||Hazard Ratio||6.03|2.08|<0.0001
72580084|NCT01608100|144689461|SUPERIORITY_OR_OTHER||Percent Sensitivity|84.44|||||TWO_SIDED|95.0|75.28|91.23||||||Time point: 0-2 hours||91.23|75.28|
72580085|NCT01608100|144689461|SUPERIORITY_OR_OTHER||Percent Sensitivity|92.21|||||TWO_SIDED|83.81|83.81|97.09||||||Time point: 2-4 hours||97.09|83.81|
72545603|NCT01335477|144620643|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.38||||0.005||95.0|0.19|0.77|||Log Rank||Nintedanib 150 mg bid versus Placebo.|Hazard Ratio is based on a Cox's regression model with terms for treatment, gender, age and height.||0.77|0.19|0.0050
72580086|NCT01608100|144689461|SUPERIORITY_OR_OTHER||Percent Sensitivity|93.9|||||TWO_SIDED|95.0|86.34|97.99||||||Time point: 4-9 hours||97.99|86.34|
72580087|NCT01608100|144689461|SUPERIORITY_OR_OTHER||Percent Sensitivity|85.26|||||TWO_SIDED|95.0|76.51|91.7||||||Time point: 0-2 hours||91.70|76.51|
72580088|NCT01608100|144689461|SUPERIORITY_OR_OTHER||Percent Sensitivity|91.86|||||TWO_SIDED|95.0|83.95|96.66||||||Time point: 2-4 hours||96.66|83.95|
72580089|NCT01608100|144689461|SUPERIORITY_OR_OTHER||Percent Sensitivity|94.95|||||TWO_SIDED|95.0|88.61|98.34||||||Time point: 4-9 hours||98.34|88.61|
72580090|NCT01608100|144689461|SUPERIORITY_OR_OTHER||Percent Sensitivity|87.32|||||TWO_SIDED|95.0|77.3|94.04||||||Time point: 0-2 hours||94.04|77.30|
72580091|NCT01608100|144689461|SUPERIORITY_OR_OTHER||Percent Sensitivity|92.0|||||TWO_SIDED|95.0|83.4|97.01||||||Time point: 2-4 hours||97.01|83.40|
72580092|NCT01608100|144689461|SUPERIORITY_OR_OTHER||Percent Sensitivity|93.15|||||TWO_SIDED|95.0|84.74|97.74||||||Time point: 4-9 hours||97.74|84.74|
72580093|NCT01608100|144689462|SUPERIORITY_OR_OTHER||Percent Specificity|85.73|||||TWO_SIDED|95.0|83.18|88.03||||||Time point: 0-2 hours||88.03|83.18|
72580094|NCT01608100|144689462|SUPERIORITY_OR_OTHER||Percent Specificity|85.2|||||TWO_SIDED|95.0|82.66|87.5||||||Time point: 2-4 hours||87.50|82.66|
72580095|NCT01608100|144689462|SUPERIORITY_OR_OTHER||Percent Specificity|82.82|||||TWO_SIDED|95.0|79.99|85.4||||||Time point: 4-9 hours||85.40|79.99|
72580096|NCT01608100|144689462|SUPERIORITY_OR_OTHER||Percent Specificity|83.76|||||TWO_SIDED|95.0|81.12|86.17||||||Time point: 0-2 hours||86.17|81.12|
72580097|NCT01608100|144689462|SUPERIORITY_OR_OTHER||Percent Specificity|83.72|||||TWO_SIDED|95.0|81.09|86.11||||||Time point: 2-4 hours||86.11|81.09|
72580098|NCT01608100|144689462|SUPERIORITY_OR_OTHER||Percent Specificity|80.72|||||TWO_SIDED|95.0|77.82|83.39||||||Time point: 4-9 hours||83.39|77.82|
72580099|NCT01608100|144689462|SUPERIORITY_OR_OTHER||Percent Specificity|86.35|||||TWO_SIDED|95.0|83.79|88.63||||||Time point: 0-2 hours||88.63|83.79|
72580100|NCT01608100|144689462|SUPERIORITY_OR_OTHER||Percent Specificity|85.81|||||TWO_SIDED|95.0|83.31|88.07||||||Time point: 2-4 hours||88.07|83.31|
72580101|NCT01608100|144689462|SUPERIORITY_OR_OTHER||Percent Specificity|84.05|||||TWO_SIDED|95.0|81.31|86.54||||||Time point: 4-9 hours||86.54|81.31|
72545604|NCT01335477|144620644|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|109.77|STANDARD_ERROR_OF_MEAN|19.808|<|0.0001||95.0|70.92|148.62|||Mixed Models Analysis||"Within-patient errors are modelled by compound symmetry covariance matrix.~Nintedanib 150 mg bid versus Placebo."|Based on Mixed Model for Repeated Measures (MMRM), with fixed effects for treatment, visit, gender, age, height, treatment-by-visit, baseline FVC, baseline FVC-by-visit and random effect for patient.||148.62|70.92|<0.0001
72545605|NCT01335477|144620645|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.24|STANDARD_ERROR_OF_MEAN|0.742|<|0.0001||95.0|2.78|5.69|||Mixed Models Analysis||"Within-patient errors are modelled by compound symmetry covariance matrix.~Nintedanib 150 mg bid versus Placebo."|Based on Mixed Model for Repeated Measures (MMRM), with fixed effects for treatment, visit, gender, age, height, treatment-by-visit, baseline FVC, baseline FVC-by-visit and random effect for patient.||5.69|2.78|<0.0001
72545606|NCT01335477|144620646|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.06|STANDARD_ERROR_OF_MEAN|0.607|<|0.0001||95.0|1.87|4.25|||Mixed Models Analysis||"Within-patient errors are modelled by compound symmetry covariance matrix.~Nintedanib 150 mg bid versus Placebo."|Based on Mixed Model for Repeated Measures (MMRM), with fixed effects for treatment, visit, gender, age, height, treatment-by-visit, baseline FVC \[%predicted\], baseline FVC \[%predicted\]-by-visit and random effect for patient.||4.25|1.87|<0.0001
72411705|NCT00406029|144331706|SUPERIORITY_OR_OTHER||Difference in LS Means|0.6||||0.296|TWO_SIDED|95.0|-0.5|1.7|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.7|-0.5|0.296
72411706|NCT00406029|144331706|SUPERIORITY_OR_OTHER||Difference in LS Means|0.7||||0.241|TWO_SIDED|95.0|-0.5|1.8|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.8|-0.5|0.241
72411707|NCT00406029|144331706|SUPERIORITY_OR_OTHER||Difference in LS Means|0.4||||0.571|TWO_SIDED|95.0|-0.9|1.6|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.6|-0.9|0.571
72411708|NCT00406029|144331706|SUPERIORITY_OR_OTHER||Difference in LS Means|1.3||||0.032|TWO_SIDED|95.0|0.1|2.4|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.||2.4|0.1|0.032
72411709|NCT00406029|144331706|SUPERIORITY_OR_OTHER||Difference in LS Means|0.8||||0.214|TWO_SIDED|95.0|-0.4|2.0|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.||2.0|-0.4|0.214
72411710|NCT00406029|144331706|SUPERIORITY_OR_OTHER||Difference in LS Means|1.2||||0.051|TWO_SIDED|95.0|0.0|2.5|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.||2.5|0.0|0.051
72411711|NCT00406029|144331706|SUPERIORITY_OR_OTHER||Difference in LS Means|0.3||||0.572|TWO_SIDED|95.0|-0.9|1.5|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.5|-0.9|0.572
72580102|NCT01608100|144689463|SUPERIORITY_OR_OTHER||Negative Predictive Value|98.1|||||TWO_SIDED|95.0|96.82|98.95||||||Time point: 0-2 hours||98.95|96.82|
72580103|NCT01608100|144689463|SUPERIORITY_OR_OTHER||Negative Predictive Value|99.19|||||TWO_SIDED|95.0|98.25|99.7||||||Time point: 2-4 hours||99.70|98.25|
72411712|NCT00406029|144331706|SUPERIORITY_OR_OTHER||Difference in LS Means|1.2||||0.041|TWO_SIDED|95.0|0.1|2.4|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.||2.4|0.1|0.041
72411713|NCT00406029|144331706|SUPERIORITY_OR_OTHER||Difference in LS Means|0.7||||0.24|TWO_SIDED|95.0|-0.5|1.9|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.9|-0.5|0.240
72411714|NCT00406029|144331706|SUPERIORITY_OR_OTHER||Difference in LS Means|1.2||||0.047|TWO_SIDED|95.0|0.0|2.4|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.||2.4|0.0|0.047
72545607|NCT01335477|144620647|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.21|STANDARD_ERROR_OF_MEAN|0.743|<|0.0001||95.0|2.76|5.67|||Mixed Models Analysis||"Within-patient errors are modelled by compound symmetry covariance matrix.~Nintedanib 150 mg bid versus Placebo."|Based on Mixed Model for Repeated Measures (MMRM), with fixed effects for treatment, visit, gender, age, height, treatment-by-visit, baseline FVC \[%predicted\], baseline FVC \[%predicted\]-by-visit and random effect for patient.||5.67|2.76|<0.0001
72580104|NCT01608100|144689463|SUPERIORITY_OR_OTHER||Negative Predictive Value|99.23|||||TWO_SIDED|95.0|98.22|99.75||||||Time point: 4-9 hours||99.75|98.22|
72580105|NCT01608100|144689463|SUPERIORITY_OR_OTHER||Negative Predictive Value|98.08|||||TWO_SIDED|95.0|96.81|98.95||||||Time point: 0-2 hours||98.95|96.81|
72580106|NCT01608100|144689463|SUPERIORITY_OR_OTHER||Negative Predictive Value|99.05|||||TWO_SIDED|95.0|98.05|99.62||||||Time point: 2-4 hours||99.62|98.05|
72580107|NCT01608100|144689463|SUPERIORITY_OR_OTHER||Negative Predictive Value|99.24|||||TWO_SIDED|95.0|98.22|99.75||||||Time point: 4-9 hours||99.75|98.22|
72580108|NCT01608100|144689463|SUPERIORITY_OR_OTHER||Negative Predictive Value|98.73|||||TWO_SIDED|95.0|97.61|99.42||||||Time point: 0-2 hours||99.42|97.61|
72411715|NCT00406029|144331706|SUPERIORITY_OR_OTHER||Difference in LS Means|0.8||||0.228|TWO_SIDED|95.0|-0.5|2.2|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.||2.2|-0.5|0.228
72411716|NCT00406029|144331706|SUPERIORITY_OR_OTHER||Difference in LS Means|1.4||||0.03|TWO_SIDED|95.0|0.1|2.6|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.||2.6|0.1|0.030
72580109|NCT01608100|144689463|SUPERIORITY_OR_OTHER||Negative Predictive Value|99.2|||||TWO_SIDED|95.0|98.27|99.71||||||Time point: 2-4 hours||99.71|98.27|
72411717|NCT00406029|144331706|SUPERIORITY_OR_OTHER||Difference in LS Means|1.2||||0.059|TWO_SIDED|95.0|0.0|2.5|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.||2.5|0.0|0.059
72411718|NCT00406029|144331706|SUPERIORITY_OR_OTHER||Difference in LS Means|1.5||||0.021|TWO_SIDED|95.0|0.2|2.7|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.||2.7|0.2|0.021
72411719|NCT00406029|144331706|SUPERIORITY_OR_OTHER||Difference in LS Means|0.4||||0.428|TWO_SIDED|95.0|-0.6|1.5|||ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.5|-0.6|0.428
72411720|NCT00406029|144331706|SUPERIORITY_OR_OTHER||Difference in LS Means|1.2||||0.025|TWO_SIDED|95.0|0.2|2.3|||ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.||2.3|0.2|0.025
72545608|NCT01335477|144620650|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.286||||0.1833||95.0|0.89|1.86|||Regression, Logistic||Nintedanib 150 mg bid versus Placebo|Logistic regression with terms treatment, age, gender, height and baseline FVC % predicted||1.86|0.89|0.1833
72545609|NCT01335477|144620651|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.794||||0.0011||95.0|1.26|2.55|||Regression, Logistic||Nintedanib 150 mg bid versus Placebo|Logistic regression with terms treatment, age, gender, height and baseline FVC % predicted.||2.55|1.26|0.0011
72580110|NCT01608100|144689463|SUPERIORITY_OR_OTHER||Negative Predictive Value|99.25|||||TWO_SIDED|95.0|98.26|99.76||||||Time point: 4-9 hours||99.76|98.26|
72580111|NCT01608100|144689464|SUPERIORITY_OR_OTHER||Positive Predictive Value|38.78|||||TWO_SIDED|95.0|31.92|45.98||||||Time point: 0-2 hours||45.98|31.92|
72580112|NCT01608100|144689464|SUPERIORITY_OR_OTHER||Positive Predictive Value|35.68|||||TWO_SIDED|95.0|29.03|42.76||||||Time point: 2-4 hours||42.76|29.03|
72580113|NCT01608100|144689464|SUPERIORITY_OR_OTHER||Positive Predictive Value|36.49|||||TWO_SIDED|95.0|29.99|43.38||||||Time point: 4-9 hours||43.38|29.99|
72580114|NCT01608100|144689464|SUPERIORITY_OR_OTHER||Positive Predictive Value|36.82|||||TWO_SIDED|95.0|30.43|43.56||||||Time point: 0-2 hours||43.56|30.43|
72580115|NCT01608100|144689464|SUPERIORITY_OR_OTHER||Positive Predictive Value|35.75|||||TWO_SIDED|95.0|29.43|42.45||||||Time point: 2-4 hours||42.45|29.43|
72580116|NCT01608100|144689464|SUPERIORITY_OR_OTHER||Positive Predictive Value|37.75|||||TWO_SIDED|95.0|31.71|44.09||||||Time point: 4-9 hours||44.09|31.71|
72580117|NCT01608100|144689464|SUPERIORITY_OR_OTHER||Positive Predictive Value|35.84|||||TWO_SIDED|95.0|28.7|43.47||||||Time point: 0-2 hours||43.47|28.70|
72580118|NCT01608100|144689464|SUPERIORITY_OR_OTHER||Positive Predictive Value|35.94|||||TWO_SIDED|95.0|29.16|43.16||||||Time point: 2-4 hours||43.16|29.16|
72580119|NCT01608100|144689464|SUPERIORITY_OR_OTHER||Positive Predictive Value|35.05|||||TWO_SIDED|95.0|28.36|42.21||||||Time point: 4-9 hours||42.21|28.36|
72580120|NCT03440840|144689480|SUPERIORITY||Mean Difference (Final Values)|2.29|STANDARD_ERROR_OF_MEAN|2.68||0.4|TWO_SIDED||||||Mixed Models Analysis|Estimated marginal means comparisons, Tukey adjustment||||||0.40
72580121|NCT03440840|144689481|SUPERIORITY||Mean Difference (Final Values)|1.86|STANDARD_ERROR_OF_MEAN|2.04||0.37|TWO_SIDED|||||Estimated marginal means comparisons, Tukey adjustment|Mixed Models Analysis|||||||0.37
72580122|NCT03440840|144689482|SUPERIORITY||Mean Difference (Final Values)|1.86|STANDARD_ERROR_OF_MEAN|2.04||0.37|TWO_SIDED||||||Mixed Models Analysis|Comparison of estimated marginal means, Tukey adjustment for multiple comparisons||||||0.37
72580123|NCT03440840|144689483|SUPERIORITY||Mean Difference (Final Values)|1.42|STANDARD_ERROR_OF_MEAN|2.77||0.61|TWO_SIDED||||||Mixed Models Analysis||Differences between estimated marginal means, Tukey correction for multiple comparisons.|||||0.61
72580124|NCT00114140|144689517|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Z-test|||Assuming exponential distribution of survival times, the null hypothesis was a 43% increase in median survival time (40.5 mo. to 57.9 mo.) and a 21% increase in 3-year survival rate (54% to 65%). Assuming 5% ineligibility, 72 patients were required to be accrued over 3 years with 3-years of follow-up resulting in 80% power and 1-sided 0.10 significance level. (N later increased to 135 to accommodate an additional separate analysis of O-6-Methylguanine-DNA Methyltransferase (MGMT) status.)||||<0.001
72580125|NCT00114140|144689519|SUPERIORITY||Hazard Ratio (HR)|3.52||||0.0006|TWO_SIDED|95.0|1.64|7.56||Two-sided significance level of 0.05|Log Rank||Reference level = Methylated|Overall survival: The sample size was increased to 135 to ensure adequate power to detect a hazard ratio (HR) of 2.5 for MGMT status, at a 2-sided significance level of 0.05 with an MGMT prevalence rate of at least 30%||7.56|1.64|0.0006
72580126|NCT00114140|144689519|SUPERIORITY||Hazard Ratio (HR)|3.06||||0.0007|TWO_SIDED|95.0|1.55|6.04||Two-sided significance level of 0.05|Log Rank||Reference level = Methylated|Progression-free survival||6.04|1.55|0.0007
72580127|NCT00535405|144689591|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-14.7|STANDARD_ERROR_OF_MEAN|1.4|<|0.001||95.0|-17.5|-12.0||Reported p-value is multiplicity-adjusted. Hochberg procedure was used to adjust for multiple comparisons.|ANCOVA|ANCOVA mixed model with fixed effects for treatment, baseline LDL-C, study week, treatment by study week interaction, and a random subject effect.||||-12.0|-17.5|<0.001
72411721|NCT00406029|144331706|SUPERIORITY_OR_OTHER||Difference in LS Means|1.0||||0.064|TWO_SIDED|95.0|-0.1|2.1|||ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.||2.1|-0.1|0.064
72411722|NCT00406029|144331706|SUPERIORITY_OR_OTHER||Difference in LS Means|1.1||||0.047|TWO_SIDED|95.0|0.0|2.1|||ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.||2.1|0.0|0.047
72411723|NCT00406029|144331707|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.4||||0.345|TWO_SIDED|95.0|-1.4|0.5|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.5|-1.4|0.345
72545610|NCT01335477|144620652|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.664||||0.0218||95.0|1.08|2.57|||Regression, Logistic||Nintedanib 150 mg bid versus Placebo|Logistic regression with terms treatment, baseline SGRQ total score||2.57|1.08|0.0218
72329506|NCT00135330|144184460|SUPERIORITY_OR_OTHER|||||||0.079||95.0|||||ANCOVA|||||||0.079
72411724|NCT00406029|144331707|SUPERIORITY_OR_OTHER||Difference in LS Means|0.3||||0.468|TWO_SIDED|95.0|-0.6|1.3|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.3|-0.6|0.468
72545611|NCT01335477|144620653|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.4|STANDARD_ERROR_OF_MEAN|1.675||0.4019||95.0|-4.69|1.88|||Mixed Models Analysis||"Within-patient errors are modelled by compound symmetry covariance matrix.~Nintedanib 150 mg bid versus Placebo."|Mixed Model for Repeated Measures (MMRM), with fixed effects for treatment, visit, treatment-by-visit, baseline SGRQ Symptoms component, baseline SGRQ Symptoms component-by-visit and random effect for patient.||1.88|-4.69|0.4019
72545612|NCT01335477|144620654|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.08|STANDARD_ERROR_OF_MEAN|1.342||0.022||95.0|-5.71|-0.45|||Mixed Models Analysis||"Within-patient error are modelled by compound symmetry covariance matrix.~Nintedanib 150 mg bid versus Placebo."|Mixed Model for Repeated Measures (MMRM), with fixed effects for treatment, visit, treatment-by-visit, baseline SGRQ impact component, baseline SGRQ impact component-by-visit and random effect for patient||-0.45|-5.71|0.0220
72580128|NCT00535405|144689591|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-7.5|STANDARD_ERROR_OF_MEAN|1.4|<|0.001||95.0|-10.3|-4.8||Reported p-value is multiplicity-adjusted. Hochberg procedure was used to adjust for multiple comparisons.|ANCOVA|ANCOVA mixed model with fixed effects for treatment, baseline LDL-C, study week, treatment by study week interaction, and a random subject effect.||||-4.8|-10.3|<0.001
72580129|NCT00535405|144689591|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-8.2|STANDARD_ERROR_OF_MEAN|1.4|<|0.001||95.0|-11.0|-5.5||Reported p-value is multiplicity-adjusted. Hochberg procedure was used to adjust for multiple comparisons.|ANCOVA|ANCOVA mixed model with fixed effects for treatment, baseline LDL-C, study week, treatment by study week interaction, and a random subject effect.||||-5.5|-11.0|<0.001
72580130|NCT00535405|144689592|SUPERIORITY_OR_OTHER_LEGACY||Ratio of odds|12.62|STANDARD_ERROR_OF_MEAN|3.23|<|0.001||95.0|7.64|20.83||Reported p-value is multiplicity-adjusted. Hochberg procedure was used to adjust for multiple comparisons.|Logistic Regression using GEE|"Model include terms for treatment, baseline LDL-C, study week and treatment by study week interaction.~Generalized Estimating Equations (GEE)"|Ratio of odds of achieving pre-specified LDL-C level on EZ/Simva versus Atorva|||20.83|7.64|<0.001
72580131|NCT00535405|144689592|SUPERIORITY_OR_OTHER_LEGACY||Ratio of odds|3.83|STANDARD_ERROR_OF_MEAN|0.83|<|0.001||95.0|2.51|5.85||Reported p-value is multiplicity-adjusted. Hochberg procedure was used to adjust for multiple comparisons.|Logistic Regression using GEE|Model include terms for treatment, baseline LDL-C, study week and treatment by study week interaction.|Ratio of odds of achieving pre-specified LDL-C level on EZ/Simva versus Atorva|||5.85|2.51|<0.001
72580132|NCT00535405|144689592|SUPERIORITY_OR_OTHER_LEGACY||Ratio of odds|3.66|STANDARD_ERROR_OF_MEAN|0.79|<|0.001||95.0|2.39|5.6|||Logistic Regression using GEE|Model include terms for treatment, baseline LDL-C, study week and treatment by study week interaction.|Ratio of odds of achieving pre-specified LDL-C level on EZ/Simva versus Atorva|||5.60|2.39|<0.001
72580133|NCT00535405|144689593|SUPERIORITY_OR_OTHER_LEGACY||Ratio of odds|3.05|STANDARD_ERROR_OF_MEAN|0.62|<|0.001||95.0|2.04|4.55||Reported p-value is multiplicity-adjusted. Hochberg procedure was used to adjust for multiple comparisons.|Logistic Regression using GEE|Model include terms for treatment, baseline LDL-C, study week and treatment by study week interaction.|Ratio of odds of achieving pre-specified LDL-C level on EZ/Simva versus Atorva|||4.55|2.04|<0.001
72580134|NCT00535405|144689593|SUPERIORITY_OR_OTHER_LEGACY||Ratio of odds|1.54|STANDARD_ERROR_OF_MEAN|0.32||0.039||95.0|1.02|2.32||Reported p-value is multiplicity-adjusted. Hochberg procedure was used to adjust for multiple comparisons.|Logistic Regression using GEE|Model include terms for treatment, baseline LDL-C, study week and treatment by study week interaction.|Ratio of odds of achieving pre-specified LDL-C level on EZ/Simva versus Atorva|||2.32|1.02|0.039
72580135|NCT00535405|144689593|SUPERIORITY_OR_OTHER_LEGACY||Ratio of odds|1.81|STANDARD_ERROR_OF_MEAN|0.43||0.023||95.0|1.14|2.87||Reported p-value is multiplicity-adjusted. Hochberg procedure was used to adjust for multiple comparisons.|Logistic Regression using GEE|Model include terms for treatment, baseline LDL-C, study week and treatment by study week interaction.|Ratio of odds of achieving pre-specified LDL-C level on EZ/Simva versus Atorva|||2.87|1.14|0.023
72580136|NCT00535405|144689594|SUPERIORITY_OR_OTHER_LEGACY||Ratio of odds|4.47|STANDARD_ERROR_OF_MEAN|1.1|<|0.001||95.0|2.76|7.24||Reported p-value is multiplicity-adjusted. Hochberg procedure was used to adjust for multiple comparisons.|Logistic Regression using GEE|Model include terms for treatment, baseline LDL-C, study week and treatment by study week interaction.|Ratio of odds of achieving pre-specified LDL-C level on EZ/Simva versus Atorva|||7.24|2.76|<0.001
72329507|NCT00135330|144184461|SUPERIORITY_OR_OTHER|||||||0.252||95.0|||||ANCOVA|||||||0.252
72329508|NCT00135330|144184462|SUPERIORITY_OR_OTHER|||||||0.465||95.0|||||ANCOVA|||||||0.465
72411725|NCT00406029|144331707|SUPERIORITY_OR_OTHER||Difference in LS Means|0.3||||0.596|TWO_SIDED|95.0|-0.7|1.2|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.2|-0.7|0.596
72545613|NCT01335477|144620655|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.31|STANDARD_ERROR_OF_MEAN|1.36||0.0152||95.0|-5.97|-0.64|||Mixed Models Analysis||"Within-patient errors are modelled by compound symmetry covariance matrix.~Nintedanib 150 mg bid versus Placebo."|Mixed Model for Repeated Measures (MMRM), with fixed effects for treatment, visit, treatment-by-visit, baseline SGRQ Activities component, baseline SGRQ Activities component-by-visit and random effect for patient||-0.64|-5.97|0.0152
72545614|NCT01335477|144620656|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.12|STANDARD_ERROR_OF_MEAN|1.192||0.0089||95.0|-5.46|-0.79|||Mixed Models Analysis||"Within-patient errors are modelled by compound symmetry covariance matrix.~Nintedanib 150 mg bid versus Placebo."|Mixed Model for Repeated Measures (MMRM), with fixed effects for treatment, visit, treatment-by-visit, baseline SGRQ-I Total score, baseline SGRQ-I Total score-by-visit and random effect for patient.||-0.79|-5.46|0.0089
72545615|NCT01335477|144620657|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.38|STANDARD_ERROR_OF_MEAN|1.685||0.1587||95.0|-5.68|0.93|||Mixed Models Analysis||"Within-patient errors are modelled by compound symmetry covariance matrix.~Nintedanib 150 mg bid versus Placebo."|Mixed Model for Repeated Measures (MMRM), with fixed effects for treatment, visit, treatment-by-visit, baseline SOBQ score, baseline SOBQ score-by-visit and random effect for patient.||0.93|-5.68|0.1587
72545616|NCT01335477|144620658|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.05|STANDARD_ERROR_OF_MEAN|1.713||0.2326||95.0|-1.31|5.41|||Mixed Models Analysis||"Within-patient errors are modelled by compound symmetry covariance matrix.~Nintedanib 150 mg bid versus Placebo."|Mixed Model for Repeated Measures (MMRM), with fixed effects for treatment, visit, treatment-by-visit, baseline CASA-Q Cough symptoms score, baseline CASA-Q Cough symptoms score-by-visit and random effect for patient.||5.41|-1.31|0.2326
72329509|NCT00135330|144184463|SUPERIORITY_OR_OTHER|||||||0.348||95.0|||||ANCOVA|||||||0.348
72329510|NCT00135330|144184467|SUPERIORITY_OR_OTHER|||||||0.039||95.0|||||Mixed Model Repeated Measures (MMRM)|||||||0.039
72411726|NCT00406029|144331707|SUPERIORITY_OR_OTHER||Difference in LS Means|0.8||||0.107|TWO_SIDED|95.0|-0.2|1.7|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.7|-0.2|0.107
72545617|NCT01335477|144620659|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.81|STANDARD_ERROR_OF_MEAN|1.564||0.2475||95.0|-1.26|4.88|||Mixed Models Analysis||"Within-patient errors are modelled by compound symmetry covariance matrix.~Nintedanib 150 mg bid versus Placebo"|Mixed Model for Repeated Measures (MMRM), with fixed effects for treatment, visit, treatment-by-visit, baseline CASA-Q Cough impact score, baseline CASA-Q Cough impact score-by-visit and random effect for patient.||4.88|-1.26|0.2475
72545618|NCT01335477|144620660|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.379||||0.069||95.0|0.98|1.95|||Regression, Logistic||Nintedanib 150 mg bid versus Placebo|Logistic regression with term treatment||1.95|0.98|0.0690
72545619|NCT01335477|144620662|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.38||||0.007||95.0|0.19|0.77|||Normal distribution|Risk ratio was calculated as the ratio of risk of exacerbation in both treatment groups.|Nintedanib 150 mg bid versus Placebo|The log of the risk ratio was assumed to follow a normal distribution with mean 0 and variance equal to the sum of the reciprocals of the number of patients with at least one exacerbation in each treatment arm.||0.77|0.19|0.0070
72545620|NCT01335477|144620663|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.74||||0.2995||95.0|0.4|1.35|||Log Rank||Nintedanib 150 mg bid versus Placebo|Hazard ratio is based on a Cox´s regression model with terms for treatment, gender, age and height.||1.35|0.40|0.2995
72545621|NCT01335477|144620664|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.86||||0.6654||95.0|0.39|1.9|||Log Rank||Nintedanib 150 mg bid versus Placebo|Hazard ratio is based on Cox´s regression model with terms for treatment, gender, age and height.||1.90|0.39|0.6654
72545622|NCT01335477|144620665|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.68||||0.2209||95.0|0.34|1.35|||Log Rank||Nintedanib 150 mg bid versus Placebo|Hazard ratio is based on a Cox´s regression model with terms for treatment, gender, age and height.||1.35|0.34|0.2209
72545623|NCT01335477|144620666|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.67||||0.1664||95.0|0.37|1.21|||Log Rank||Nintedanib 150 mg bid versus Placebo|Hazard ratio is based on Cox´s regression model with terms for treatment, gender, age and height.||1.21|0.37|0.1664
72545624|NCT01335477|144620667|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.8||||0.2123||95.0|0.55|1.16|||Log Rank||Nintedanib 150 mg bid versus Placebo|Hazard ratio is based on Cox´s regression model with terms for treatment, gender, age and height.||1.16|0.55|0.2123
72545625|NCT01335477|144620668|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.27|STANDARD_ERROR_OF_MEAN|0.213||0.2032||95.0|-0.15|0.69|||Mixed Models Analysis||"Within-patient errors are modelled by compound symmetry covariance matrix.~Nintedanib 150 mg bid versus Placebo."|Mixed Model for Repeated Measures (MMRM), with fixed effects for treatment, visit, gender, age, height, treatment-by-visit, baseline SpO2, baseline SpO2-by-visit and random effect for patient.||0.69|-0.15|0.2032
72329511|NCT00135330|144184468|SUPERIORITY_OR_OTHER|||||||0.555||95.0|||||MMRM|||||||0.555
72329512|NCT00135330|144184470|SUPERIORITY_OR_OTHER|||||||0.106||95.0|||||MMRM|||||||0.106
72545626|NCT01335477|144620669|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.113|STANDARD_ERROR_OF_MEAN|0.1005||0.26||95.0|-0.084|0.31|||Mixed Models Analysis||"Within-patient errors are modelled by compound symmetry covariance matrix.~Nintedanib 150 mg bid versus Placebo."|Mixed Model for Repeated Measures with fixed effects for treatment, visit, gender, age, height, treatment-by-visit, baseline DLCO (HGB Corrected) \[mmol/min/kPa\], baseline DLCO (HGB Corrected) \[mmol/min/kPa\]-by-visit and random effect for patient.||0.310|-0.084|0.2600
72329513|NCT00135330|144184471|SUPERIORITY_OR_OTHER|||||||0.341||95.0|||||MMRM|||||||0.341
72329514|NCT00135330|144184472|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||MMRM|||||||<0.001
72329515|NCT00135330|144184473|SUPERIORITY_OR_OTHER|||||||0.276||95.0|||||MMRM|||||||0.276
72545627|NCT03031899|144620676|NON_INFERIORITY|"1. Rose bengal should stain the areas positively stained by Toluidine blue~2. areas stained by rose bengal that shows dysplasia in biopsy"|SN, SP, PPV, NPV|||||0.005|||||||Chi-squared|||||||0.005
72545628|NCT01469364|144620680|SUPERIORITY_OR_OTHER|||||||0.203|TWO_SIDED||||||t-test, 2 sided|Paired t-test 2 sided.||||||0.2030
72545629|NCT01469364|144620681|SUPERIORITY_OR_OTHER|||||||0.2527|TWO_SIDED||||||t-test, 2 sided|Paired t-test 2 sided.||||||0.2527
72545630|NCT01469364|144620686|SUPERIORITY_OR_OTHER||Mean Absolute Difference|-1.52||||0.34|TWO_SIDED||||||t-test, 2 sided|Paired Measured t-test||P-Value for the SF-36 PCS||||0.34
72545631|NCT01469364|144620686|SUPERIORITY_OR_OTHER||Median Absolute Difference|0.78||||0.18|TWO_SIDED||||||t-test, 2 sided|Paired Measured t-test||P-Value for the SF-36 MCS||||0.18
72545632|NCT01469364|144620687|SUPERIORITY_OR_OTHER||Median Absolute Difference|1.62||||0.09|TWO_SIDED||||||t-test, 2 sided|Paired Measure t-test||P-Value for SF-36 PCS||||0.09
72545633|NCT01469364|144620687|SUPERIORITY_OR_OTHER||Median Absolute Difference|-1.24||||0.31|TWO_SIDED||||||t-test, 2 sided|Paired Measure t-test||P-Value for SF-36 MCS||||0.31
72545634|NCT01469364|144620688|SUPERIORITY_OR_OTHER||Median Absolute Difference|0.82||||0.56|TWO_SIDED||||||t-test, 2 sided|Paired Measure t-test||P-Value for SGRQ measure||||0.56
72545635|NCT01469364|144620689|SUPERIORITY_OR_OTHER||Median Absolute Difference|0.15||||0.68|TWO_SIDED||||||t-test, 2 sided|Paired Measure t-test||P-Value for SGRQ Measure||||0.68
72545636|NCT01469364|144620690|SUPERIORITY_OR_OTHER|||||||0.7454|TWO_SIDED||||||t-test, 2 sided|Paired t-test 2 sided.||||||0.7454
72545637|NCT01469364|144620691|SUPERIORITY_OR_OTHER|||||||0.9638|TWO_SIDED||||||t-test, 2 sided|Paired t-test was completed.||||||0.9638
72545638|NCT02040428|144620718|SUPERIORITY_OR_OTHER|||||||0.0001|ONE_SIDED||||||Adaptive group sequential design|Whitehead method for triangular test||Superiority||||0.0001
72545639|NCT02040428|144620719|SUPERIORITY_OR_OTHER|||||||0.0046|TWO_SIDED||||||Chi-squared|||||||0.0046
72545640|NCT01399723|144620729|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority between amoxicillin and benzyl penicillin was defined a priori as a risk difference of treatment failure and associated upper bound of the 95% confidence interval (CI) of \<7%. A sample size of 576 would provide 80% power to detect noninferiority of amoxicillin against benzyl penicillin within a margin of 7% at a 1-sided level of significance of 0.025, assuming a prevalence of treatment failure of 10% at 48 hours derived from a preintervention pilot phase of the study|Risk Difference (RD)|-0.4|||||TWO_SIDED|95.0|-5.0|4.2|||||Risk difference comparison is for amoxicillin versus benzyl penicillin|||4.2|-5.0|
72545641|NCT01399723|144620730|NON_INFERIORITY_OR_EQUIVALENCE|The initial sample size estimate of 576 children (288 per group) would provide 80% power to detect noninferiority of amoxicillin against benzyl penicillin within a margin of 7% at a 1-sided level of significance of 0.025, assuming a prevalence of treatment failure of 10% at 48 hours derived from a preintervention pilot phase of the study|Risk Difference (RD)|0.4|||||TWO_SIDED|95.0|-5.0|5.8|||||Risk difference comparison is for amoxicillin versus benzyl penicillin|||5.8|-5.0|
72545642|NCT01399723|144620733|NON_INFERIORITY_OR_EQUIVALENCE|The initial sample size estimate of 576 children (288 per group) would provide 80% power to detect noninferiority of amoxicillin against benzyl penicillin within a margin of 7% at a 1-sided level of significance of 0.025, assuming a prevalence of treatment failure of 10% at 48 hours derived from a preintervention pilot phase of the study|Risk Difference (RD)|-3.3|||||TWO_SIDED|95.0|-10.0|3.0|||||Risk difference comparison is for amoxicillin versus benzyl penicillin|||3.0|-10.0|
72545643|NCT03051256|144620737|SUPERIORITY||||||<|0.0122|||||||Mixed Models Analysis|||||||<0.0122
72545644|NCT03051256|144620737|SUPERIORITY||||||<|0.0308|||||||Mixed Models Analysis|||||||<0.0308
72545645|NCT03051256|144620738|SUPERIORITY||||||<|0.0103|||||||Mixed Models Analysis|||||||<0.0103
72545646|NCT03051256|144620738|SUPERIORITY||||||<|0.0039|||||||Mixed Models Analysis|||||||<0.0039
72545647|NCT03051256|144620739|SUPERIORITY|||||||0.1237|||||||Mixed Models Analysis|||||||0.1237
72545648|NCT03051256|144620739|SUPERIORITY|||||||0.1017|||||||Mixed Models Analysis|||||||0.1017
72545649|NCT03051256|144620740|SUPERIORITY||||||<|0.0066|||||||Mixed Models Analysis|||||||<0.0066
72545650|NCT03051256|144620740|SUPERIORITY||||||<|0.0014|||||||Mixed Models Analysis|||||||<0.0014
72545651|NCT03051256|144620741|SUPERIORITY||||||<|0.0245|||||||Mixed Models Analysis|||||||<0.0245
72545652|NCT03051256|144620741|SUPERIORITY||||||<|0.0253|||||||Mixed Models Analysis|||||||<0.0253
72545653|NCT03051256|144620742|SUPERIORITY||||||<|0.0454|||||||Mixed Models Analysis|||||||<0.0454
72545654|NCT03051256|144620742|SUPERIORITY||||||<|0.0043|||||||Mixed Models Analysis|||||||<0.0043
72545655|NCT03051256|144620743|SUPERIORITY|||||||0.0177|||||||Mixed Models Analysis|||||||0.0177
72545656|NCT03051256|144620743|SUPERIORITY|||||||0.0072|||||||Mixed Models Analysis|||||||0.0072
72545657|NCT03051256|144620744|SUPERIORITY|||||||0.0895|||||||Mixed Models Analysis|||||||0.0895
72545658|NCT03051256|144620744|SUPERIORITY|||||||0.0109|||||||Mixed Models Analysis|||||||0.0109
72552598|NCT02728102|144636042|EQUIVALENCE|The stratified odds ratio is estimated with 80% confidence intervals.|Odds Ratio (OR)|1.19||||0.7461|TWO_SIDED|80.0|0.7|2.03||P-value is provided by Breslow-Day Test for Homogeneity of the Odds Ratios.|Cochran-Mantel-Haenszel||The Cochran-Mantel-Haenszel Odds Ratio estimate is for the Stratification. Stratum 1 is sCR/CR at Randomization. Stratum 2 is VGPR/PR/Stable Response at Randomization.|A secondary analysis stratified on disease response prior to randomization between arms will be conducted using a Cochran-Mantel-Haenszel test, and a stratified odds ratio along with 80% confidence intervals will be estimated.||2.03|0.70|0.7461
72411727|NCT00406029|144331707|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.6||||0.348|TWO_SIDED|94.0|-1.8|0.6|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.6|-1.8|0.348
72545659|NCT00294723|144620750|NON_INFERIORITY_OR_EQUIVALENCE|The two sided 95% confidence interval for the treatment difference \[liraglutide - glimepiride\] was estimated. Liraglutide was shown to be non-inferior to glimepiride if the upper limit of the two-sided 95% CI for the treatment difference was below 0.4% and superior if the complete confidence interval was below 0%.|Estimated treatment difference, LS Mean|-0.62|||<|0.0001||95.0|-0.83|-0.42||"The statistical analysis of the primary endpoint was done in a hierarchal manner due to multiple comparisons. No other adjustments were made for multiplicity.~2-sided significance level 5%"|ANCOVA|||Change in glycosylated haemoglobin (HbA1c) from baseline to end of treatment at 52 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous oral antidiabetic drug (OAD) treatment as fixed effects and baseline HbA1c as covariate.||-0.42|-0.83|<0.0001
72545660|NCT00294723|144620750|NON_INFERIORITY_OR_EQUIVALENCE|The two sided 95% confidence interval for the treatment difference \[liraglutide - glimepiride\] was estimated. Liraglutide was shown to be non-inferior to glimepiride if the upper limit of the two-sided 95% CI for the treatment difference was below 0.4% and superior if the complete confidence interval was below 0%. Superiority of 1.2 mg liraglutide was only tested if 1.2 mg liraglutide was non-inferior to glimepiride and 1.8 mg liraglutide was superior to glimepiride.|Estimated treatment difference, LS Mean|-0.33||||0.0014||95.0|-0.53|-0.13||"The statistical analysis of the primary endpoint was done in a hierarchal manner due to multiple comparisons. No other adjustments were made for multiplicity.~2-sided significance level 5%"|ANCOVA|||Change in glycosylated haemoglobin (HbA1c) from baseline to end of treatment at 52 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous oral antidiabetic drug (OAD) treatment as fixed effects and baseline HbA1c as covariate.||-0.13|-0.53|0.0014
72545661|NCT00294723|144620750|NON_INFERIORITY_OR_EQUIVALENCE|A test for superiority of liraglutide 1.8 mg to liraglutide 1.2 mg was performed to compare the two doses. Superiority of liraglutide 1.8 mg was concluded if the upper limit of the 2-sided 95% CI for the treatment difference (liraglutide 1.8 mg - liraglutide 1.2 mg) was below 0%.|Estimated treatment difference, LS Mean|-0.29||||0.0046||95.0|-0.5|-0.09||2-sided significance level 5%|ANCOVA|||Change in glycosylated haemoglobin (HbA1c) from baseline to end of treatment at 52 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous oral antidiabetic drug (OAD) treatment as fixed effects and baseline HbA1c as covariate.||-0.09|-0.50|0.0046
72545662|NCT00294723|144620751|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg and glimepiride was calculated. If the upper limit of the 95% CI was below 0 kg, it was concluded that the given dose of liraglutide was better than glimepiride.|Estimated treatment difference, LS Mean|-3.58|||<|0.0001||95.0|-4.28|-2.87||2-sided significance level 5%|ANCOVA|||Change in body weight from baseline to end of treatment at 52 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline body weight as covariate.||-2.87|-4.28|<.0001
72545663|NCT00294723|144620751|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.2 mg and glimepiride was calculated. If the upper limit of the 95% CI was below 0 kg, it was concluded that the given dose of liraglutide was better than glimepiride.|Estimated treatment difference, LS Mean|-3.17|||<|0.0001||95.0|-3.87|-2.47||2-sided significance level 5%|ANCOVA|||Change in body weight from baseline to end of treatment at 52 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline body weight as covariate.||-2.47|-3.87|<.0001
72545664|NCT00294723|144620751|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg and liraglutide 1.2 mg was calculated. If the upper limit of the 95% CI was below 0 kg, it was concluded that the liraglutide 1.8 mg was better than liraglutide 1.2 mg.|Estimated treatment difference, LS Mean|-0.41||||0.2584||95.0|-1.11|0.3||2-sided significance level 5%|ANCOVA|||Change in body weight from baseline to end of treatment at 52 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline body weight as covariate.||0.30|-1.11|0.2584
72545665|NCT00294723|144620752|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg and glimepiride was calculated. If the upper limit of the 95% CI was below 0 kg, it was concluded that the given dose of liraglutide was better than glimepiride.|Estimated treatment difference, LS Mean|-3.65|||<|0.0001||95.0|-4.44|-2.86||2-sided significance level 5%|ANCOVA|||Change in body weight from baseline to end of treatment at 104 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline body weight as covariate.||-2.86|-4.44|<.0001
72411728|NCT00406029|144331707|SUPERIORITY_OR_OTHER||Difference in LS Means|0.0||||0.938|TWO_SIDED|95.0|-1.1|1.2|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.2|-1.1|0.938
72552599|NCT02728102|144636042|SUPERIORITY|The proportion of patients alive and in CR/sCR at 1 year post transplant will be compared in the vaccine arm to Lenalidomide/GM-CSF arm with 80% confidence intervals using a two-sample Z test comparing binomial proportions.|difference in the proportions|7.2||||0.2429|TWO_SIDED|80.0|-6.4|20.6|||Z test|||A secondary pairwise analysis of CR/sCR rates comparing the vaccine arm to Lenalidomide/GM-CSF arm at 1 year post transplant.||20.6|-6.4|0.2429
72552600|NCT02728102|144636042|SUPERIORITY|The proportion of patients alive and in CR/sCR at 1 year post transplant will be compared in the vaccine arm to Lenalidomide alone arm with 80% confidence intervals using a two-sample Z test comparing binomial proportions.|difference in the proportions|-1.6||||0.4397|TWO_SIDED|80.0|-15.6|12.4|||Z test|||A secondary pairwise analysis of CR rates comparing the vaccine arm to Lenalidomide alone arm at 1 year post transplant.||12.4|-15.6|0.4397
72329516|NCT00135330|144184474|SUPERIORITY_OR_OTHER|||||||0.84||95.0|||||MMRM|||||||0.840
72329517|NCT00135330|144184475|SUPERIORITY_OR_OTHER|||||||0.096||95.0|||||MMRM|||||||0.096
72411729|NCT00406029|144331707|SUPERIORITY_OR_OTHER||Difference in LS Means|0.1||||0.897|TWO_SIDED|95.0|-1.1|1.3|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.3|-1.1|0.897
72411730|NCT00406029|144331707|SUPERIORITY_OR_OTHER||Difference in LS Means|0.4||||0.518|TWO_SIDED|95.0|-0.8|1.6|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.6|-0.8|0.518
72411731|NCT00406029|144331707|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.7||||0.311|TWO_SIDED|95.0|-2.2|0.7|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.7|-2.2|0.311
72545666|NCT00294723|144620752|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.2 mg and glimepiride was calculated. If the upper limit of the 95% CI was below 0 kg, it was concluded that the given dose of liraglutide was better than glimepiride.|Estimated treatment difference, LS Mean|-2.84|||<|0.0001||95.0|-3.63|-2.06||2-sided significance level 5%|ANCOVA|||Change in body weight from baseline to end of treatment at 104 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline body weight as covariate.||-2.06|-3.63|<.0001
72411732|NCT00406029|144331707|SUPERIORITY_OR_OTHER||Difference in LS Means|0.4||||0.597|TWO_SIDED|95.0|-1.0|1.7|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.7|-1.0|0.597
72411733|NCT00406029|144331707|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.1||||0.925|TWO_SIDED|95.0|-1.5|1.3|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.3|-1.5|0.925
72411734|NCT00406029|144331707|SUPERIORITY_OR_OTHER||Difference in LS Means|0.5||||0.478|TWO_SIDED|95.0|-0.9|1.9|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.9|-0.9|0.478
72411735|NCT00406029|144331707|SUPERIORITY_OR_OTHER||Difference in LS Means|0.0||||0.995|TWO_SIDED|95.0|-1.5|1.5|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.5|-1.5|0.995
72411736|NCT00406029|144331707|SUPERIORITY_OR_OTHER||Difference in LS Means|1.3||||0.057|TWO_SIDED|95.0|0.0|2.7|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.||2.7|0.0|0.057
72411737|NCT00406029|144331707|SUPERIORITY_OR_OTHER||Difference in LS Means|0.6||||0.431|TWO_SIDED|95.0|-0.9|2.0|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.||2.0|-0.9|0.431
72545667|NCT00294723|144620752|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg and liraglutide 1.2 mg was calculated. If the upper limit of the 95% CI was below 0 kg, it was concluded that the liraglutide 1.8 mg was better than liraglutide 1.2 mg.|Estimated treatment difference, LS Mean|-0.8||||0.0462||95.0|-1.59|-0.01||2-sided significance level 5%|ANCOVA|||Change in body weight from baseline to end of treatment at 104 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline body weight as covariate.||-0.01|-1.59|0.0462
72411738|NCT00406029|144331707|SUPERIORITY_OR_OTHER||Difference in LS Means|1.2||||0.099|TWO_SIDED|95.0|-0.2|2.7|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.||2.7|-0.2|0.099
72411739|NCT00406029|144331707|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.1||||0.847|TWO_SIDED|95.0|-1.5|1.3|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.3|-1.5|0.847
72411740|NCT00406029|144331707|SUPERIORITY_OR_OTHER||Difference in LS Means|1.2||||0.093|TWO_SIDED|95.0|-0.2|2.5|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.||2.5|-0.2|0.093
72411741|NCT00406029|144331707|SUPERIORITY_OR_OTHER||Difference in LS Means|0.5||||0.471|TWO_SIDED|95.0|-0.9|1.9|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.9|-0.9|0.471
72411742|NCT00406029|144331707|SUPERIORITY_OR_OTHER||Difference in LS Means|1.2||||0.102|TWO_SIDED|95.0|-0.2|2.6|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.||2.6|-0.2|0.102
72411743|NCT00406029|144331707|SUPERIORITY_OR_OTHER||Difference in LS Means|0.7||||0.415|TWO_SIDED|95.0|-0.9|2.3|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.||2.3|-0.9|0.415
72552601|NCT02728102|144636043|SUPERIORITY|||||||0.9376||||||Statistical significance was determined using a pre-specified threshold of 0.05|Chi-squared|||The proportion of participants alive and with sCR/CR/VGPR will be compared between the vaccine and the combined non-vaccine arms at 6 months Post Transplant.||||0.9376
72552602|NCT02728102|144636043|SUPERIORITY|||||||0.4887||||||Statistical significance was determined using a pre-specified threshold of 0.05|Chi-squared|||In this pairwise analysis, the proportion of participants alive and with sCR/CR/VGPR will be compared between the vaccine arm and lenalidomide/GM-CSF arm at 6 months Post Transplant.||||0.4887
72552603|NCT02728102|144636043|SUPERIORITY|||||||0.5176||||||Statistical significance was determined using a pre-specified threshold of 0.05|Chi-squared|||In this pairwise analysis, the proportion of participants alive and with sCR/CR/VGPR will be compared between the vaccine arm and lenalidomide alone arm at 6 months Post Transplant.||||0.5176
72552604|NCT02728102|144636043|SUPERIORITY|||||||0.2461||||||Statistical significance was determined using a pre-specified threshold of 0.05.|Chi-squared|||In this pairwise analysis, the proportion of participants alive and with sCR/CR/VGPR will be compared between lenalidomide/GM-CSF arm and lenalidomide alone arm at 6 months Post Transplant.||||0.2461
72411744|NCT00406029|144331707|SUPERIORITY_OR_OTHER||Difference in LS Means|1.5||||0.051|TWO_SIDED|95.0|0.0|3.0|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.||3.0|0.0|0.051
72411745|NCT00406029|144331707|SUPERIORITY_OR_OTHER||Difference in LS Means|1.3||||0.103|TWO_SIDED|95.0|-0.3|2.8|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.||2.8|-0.3|0.103
72411746|NCT00406029|144331707|SUPERIORITY_OR_OTHER||Difference in LS Means|1.7||||0.022|TWO_SIDED|95.0|0.3|3.2|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.||3.2|0.3|0.022
72411747|NCT00406029|144331707|SUPERIORITY_OR_OTHER||Difference in LS Means|0.1||||0.903|TWO_SIDED|95.0|-1.2|1.4|||ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.4|-1.2|0.903
72411748|NCT00406029|144331707|SUPERIORITY_OR_OTHER||Difference in LS Means|1.2||||0.074|TWO_SIDED|95.0|-0.1|2.5|||ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.||2.5|-0.1|0.074
72411749|NCT00406029|144331707|SUPERIORITY_OR_OTHER||Difference in LS Means|0.9||||0.185|TWO_SIDED|95.0|-0.4|2.2|||ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.||2.2|-0.4|0.185
72411750|NCT00406029|144331707|SUPERIORITY_OR_OTHER||Difference in LS Means|1.3||||0.054|TWO_SIDED|95.0|0.0|2.6|||ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.||2.6|0.0|0.054
72545668|NCT00294723|144620753|NON_INFERIORITY_OR_EQUIVALENCE|The two sided 95% confidence interval for the treatment difference \[liraglutide - glimepiride\] was estimated. Liraglutide was shown to be non-inferior to glimepiride if the upper limit of the two-sided 95% CI for the treatment difference was below 0.4% and superior if the complete confidence interval was below 0%.|Estimated treatment difference, LS Mean|-0.6|||<|0.0001||95.0|-0.83|-0.38||"The statistical analysis of the primary endpoint was done in a hierarchal manner due to multiple comparisons. No other adjustments were made for multiplicity.~2-sided significance level 5%"|ANCOVA|||Change in glycosylated haemoglobin (HbA1c) from baseline to end of treatment at 104 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous oral antidiabetic drug (OAD) treatment as fixed effects and baseline HbA1c as covariate.||-0.38|-0.83|<.0001
72545669|NCT00294723|144620753|NON_INFERIORITY_OR_EQUIVALENCE|The two sided 95% CI for the treatment difference \[liraglutide - glimepiride\] was estimated. Liraglutide was non-inferior to glimepiride if the upper limit of the two-sided 95% CI for the treatment difference was below 0.4% and superior if the complete confidence interval was below 0%. Superiority of 1.2 mg liraglutide was only tested if 1.2 mg liraglutide was non-inferior to glimepiride and 1.8 mg liraglutide was superior to glimepiride.|Estimated treatment difference, LS Mean|-0.31||||0.0076||95.0|-0.54|-0.08||"The statistical analysis of the primary endpoint was done in a hierarchal manner due to multiple comparisons. No other adjustments were made for multiplicity.~2-sided significance level 5%"|ANCOVA|||Change in glycosylated haemoglobin (HbA1c) from baseline to end of treatment at 104 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous oral antidiabetic drug (OAD) treatment as fixed effects and baseline HbA1c as covariate.||-0.08|-0.54|0.0076
72545670|NCT00294723|144620753|NON_INFERIORITY_OR_EQUIVALENCE|A test for superiority of liraglutide 1.8 mg to liraglutide 1.2 mg was performed to compare the two doses. Superiority of liraglutide 1.8 mg was concluded if the upper limit of the 2-sided 95% CI for the treatment difference (liraglutide 1.8 mg - liraglutide 1.2 mg) was below 0%.|Estimated treatment difference, LS Mean|-0.29||||0.0129||95.0|-0.52|-0.06||2-sided significance level 5%|ANCOVA|||Change in glycosylated haemoglobin (HbA1c) from baseline to end of treatment at 104 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous oral antidiabetic drug (OAD) treatment as fixed effects and baseline HbA1c as covariate.||-0.06|-0.52|0.0129
72580137|NCT00535405|144689594|SUPERIORITY_OR_OTHER_LEGACY||Ratio of odds|1.77|STANDARD_ERROR_OF_MEAN|0.46||0.026||95.0|1.07|2.94||Reported p-value is multiplicity-adjusted. Hochberg procedure was used to adjust for multiple comparisons.|Logistic Regression using GEE|Model include terms for treatment, baseline LDL-C, study week and treatment by study week interaction.|Ratio of odds of achieving pre-specified LDL-C level on EZ/Simva versus Atorva|||2.94|1.07|0.026
72580138|NCT00535405|144689594|SUPERIORITY_OR_OTHER_LEGACY||Ratio of odds|2.27|STANDARD_ERROR_OF_MEAN|0.71||0.017||95.0|1.23|4.18||Reported p-value is multiplicity-adjusted. Hochberg procedure was used to adjust for multiple comparisons.|Logistic Regression using GEE|Model include terms for treatment, baseline LDL-C, study week and treatment by study week interaction.|Ratio of odds of achieving pre-specified LDL-C level on EZ/Simva versus Atorva|||4.18|1.23|0.017
72329518|NCT00135330|144184476|SUPERIORITY_OR_OTHER|||||||0.875||95.0|||||MMRM|||||||0.875
72329519|NCT00135330|144184477|SUPERIORITY_OR_OTHER|||||||0.581||95.0|||||ANCOVA|||||||0.581
72329520|NCT00135330|144184478|SUPERIORITY_OR_OTHER|||||||0.631||95.0|||||ANCOVA|||||||0.631
72411751|NCT00406029|144331708|SUPERIORITY_OR_OTHER||Difference in LS Means|0.0||||0.985|TWO_SIDED|95.0|-0.5|0.5|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.5|-0.5|0.985
72411752|NCT00406029|144331708|SUPERIORITY_OR_OTHER||Difference in LS Means|0.1||||0.556|TWO_SIDED|95.0|-0.3|0.6|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.6|-0.3|0.556
72411753|NCT00406029|144331708|SUPERIORITY_OR_OTHER||Difference in LS Means|0.1||||0.776|TWO_SIDED|95.0|-0.4|0.5|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.5|-0.4|0.776
72411754|NCT00406029|144331708|SUPERIORITY_OR_OTHER||Difference in LS Means|0.1||||0.777|TWO_SIDED|95.0|-0.4|0.5|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.5|-0.4|0.777
72545671|NCT00294723|144620754|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg and glimepiride was calculated. If the upper limit of the 95% CI was below 0 kg, it was concluded that the given dose of liraglutide was better than glimepiride.|Estimated treatment difference, LS Mean|-3.48|||<|0.0001||95.0|-4.28|-2.68||2-sided significance level was 5%.|ANCOVA|||Change in body weight from baseline to end of treatment at 156 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country, and previous anti-diabetic treatment as fixed effects and baseline body weight as covariate.||-2.68|-4.28|<0.0001
72545672|NCT00294723|144620754|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.2 mg and glimepiride was calculated. If the upper limit of the 95% CI was below 0 kg, it was concluded that the given dose of liraglutide was better than glimepiride.|Estimated treatment difference, LS Mean|-2.72|||<|0.0001||95.0|-3.52|-1.93||2-sided significance level 5%|ANCOVA|||Change in body weight from baseline to end of treatment at 156 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country, and previous anti-diabetic treatment as fixed effects and baseline body weight as covariate.||-1.93|-3.52|<0.0001
72545673|NCT00294723|144620754|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg and liraglutide 1.2 mg was calculated. If the upper limit of the 95% CI was below 0 kg, it was concluded that the liraglutide 1.8 mg was better than liraglutide 1.2 mg.|Estimated treatment difference, LS Mean|-0.75||||0.0642||95.0|-1.55|0.05||2-sided significance level 5%|ANCOVA|||Change in body weight from baseline to end of treatment at 156 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country, and previous anti-diabetic treatment as fixed effects and baseline body weight as covariance.||0.05|-1.55|0.0642
72545674|NCT00294723|144620755|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg and glimepiride was calculated. If the upper limit of the 95% CI was below 0 mg/dL, it was concluded that the given dose of liraglutide was better than glimepiride.|Estimated treatment difference, LS Mean|-20.28|||<|0.0001||95.0|-29.09|-11.46||2-sided significance level 5%|ANCOVA|||Change in fasting plasma glucose (FPG) from baseline to end of treatment at 52 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline FPG as covariate.||-11.46|-29.09|<.0001
72580139|NCT00535405|144689595|SUPERIORITY_OR_OTHER_LEGACY||Ratio of odds|7.6|STANDARD_ERROR_OF_MEAN|2.2|<|0.001||95.0|4.31|13.42||Reported p-value is multiplicity-adjusted. Hochberg procedure was used to adjust for multiple comparisons.|Logistic Regression using GEE|Model include terms for treatment, baseline LDL-C, study week and treatment by study week interaction.|Ratio of odds of achieving pre-specified LDL-C level on EZ/Simva versus Atorva|||13.42|4.31|<0.001
72580140|NCT00535405|144689595|SUPERIORITY_OR_OTHER_LEGACY||Ratio of odds|2.95|STANDARD_ERROR_OF_MEAN|0.69|<|0.001||95.0|1.86|4.67||Reported p-value is multiplicity-adjusted. Hochberg procedure was used to adjust for multiple comparisons.|Logistic Regression using GEE|Model include terms for treatment, baseline LDL-C, study week and treatment by study week interaction.|Ratio of odds of achieving pre-specified LDL-C level on EZ/Simva versus Atorva|||4.67|1.86|<0.001
72580141|NCT00535405|144689595|SUPERIORITY_OR_OTHER_LEGACY||Ratio of odds|2.15|STANDARD_ERROR_OF_MEAN|0.46|<|0.001||95.0|1.42|3.27||Reported p-value is multiplicity-adjusted. Hochberg procedure was used to adjust for multiple comparisons.|Logistic Regression using GEE|Model include terms for treatment, baseline LDL-C, study week and treatment by study week interaction.|Ratio of odds of achieving pre-specified LDL-C level on EZ/Simva versus Atorva|||3.27|1.42|<0.001
72329521|NCT00135330|144184479|SUPERIORITY_OR_OTHER|||||||0.724||95.0|||||ANCOVA|||||||0.724
72545675|NCT00294723|144620755|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.2 mg and glimepiride was calculated. If the upper limit of the 95% CI was below 0 mg/dL, it was concluded that the given dose of liraglutide was better than glimepiride.|Estimated treatment difference, LS Mean|-9.92||||0.027||95.0|-18.7|-1.12||2-sided significance level 5%|ANCOVA|||Change in fasting plasma glucose (FPG) from baseline to end of treatment at 52 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline FPG as covariate.||-1.12|-18.70|0.0270
72580142|NCT00535405|144689596|SUPERIORITY_OR_OTHER_LEGACY||Ratio of odds|6.02|STANDARD_ERROR_OF_MEAN|2.45|<|0.001||95.0|2.71|13.38||Reported p-value is multiplicity-adjusted. Hochberg procedure was used to adjust for multiple comparisons.|Logistic Regression using GEE|Model include terms for treatment, baseline LDL-C, study week and treatment by study week interaction.|Ratio of odds of achieving pre-specified LDL-C level on EZ/Simva versus Atorva|||13.38|2.71|<0.001
72411755|NCT00406029|144331708|SUPERIORITY_OR_OTHER||Difference in LS Means|0.0||||0.92|TWO_SIDED|94.0|-0.5|0.5|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.5|-0.5|0.920
72411756|NCT00406029|144331708|SUPERIORITY_OR_OTHER||Difference in LS Means|0.4||||0.155|TWO_SIDED|95.0|-0.1|0.9|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.9|-0.1|0.155
72411757|NCT00406029|144331708|SUPERIORITY_OR_OTHER||Difference in LS Means|0.1||||0.843|TWO_SIDED|95.0|-0.5|0.6|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.6|-0.5|0.843
72411758|NCT00406029|144331708|SUPERIORITY_OR_OTHER||Difference in LS Means|0.1||||0.673|TWO_SIDED|95.0|-0.4|0.6|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.6|-0.4|0.673
72411759|NCT00406029|144331708|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.1||||0.612|TWO_SIDED|95.0|-0.7|0.4|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.4|-0.7|0.612
72411760|NCT00406029|144331708|SUPERIORITY_OR_OTHER||Difference in LS Means|0.2||||0.512|TWO_SIDED|95.0|-0.4|0.7|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.7|-0.4|0.512
72411761|NCT00406029|144331708|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.3||||0.269|TWO_SIDED|95.0|-0.9|0.2|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.2|-0.9|0.269
72411762|NCT00406029|144331708|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.2||||0.516|TWO_SIDED|95.0|-0.7|0.4|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.4|-0.7|0.516
72411763|NCT00406029|144331708|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.2||||0.597|TWO_SIDED|95.0|-0.8|0.5|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.5|-0.8|0.597
72545676|NCT00294723|144620755|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg and liraglutide 1.2 mg was calculated. If the upper limit of the 95% CI was below 0 mg/dL, it was concluded that liraglutide 1.8 mg was better than liraglutide 1.2 mg.|Estimated treatment difference, LS Mean|-10.36||||0.0223||95.0|-19.24|-1.48||2-sided significance level 5%|ANCOVA|||Change in fasting plasma glucose (FPG) from baseline to end of treatment at 52 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline FPG as covariate.||-1.48|-19.24|0.0223
72411764|NCT00406029|144331708|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.1||||0.766|TWO_SIDED|95.0|-0.7|0.5|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.5|-0.7|0.766
72411765|NCT00406029|144331708|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.3||||0.428|TWO_SIDED|95.0|-0.9|0.4|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.4|-0.9|0.428
72411766|NCT00406029|144331708|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.1||||0.796|TWO_SIDED|95.0|-0.7|0.6|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.6|-0.7|0.796
72411767|NCT00406029|144331708|SUPERIORITY_OR_OTHER||Difference in LS Means|0.0||||0.988|TWO_SIDED|95.0|-0.6|0.6|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.6|-0.6|0.988
72552605|NCT02728102|144636043|SUPERIORITY|||||||0.253||||||Statistical significance was determined using a pre-specified threshold of 0.05|Chi-squared|||The proportion of participants alive and with sCR/CR/VGPR will be compared between the vaccine and the combined non-vaccine arms at 1 year Post Transplant.||||0.2530
72552606|NCT02728102|144636043|SUPERIORITY|||||||0.2213||||||Statistical significance was determined using a pre-specified threshold of 0.05.|Chi-squared|||In this pairwise analysis, the proportion of participants alive and with sCR/CR/VGPR will be compared between the vaccine arm and lenalidomide/GM-CSF arm at 1 year Post Transplant.||||0.2213
72552607|NCT02728102|144636043|SUPERIORITY|||||||0.493||||||Statistical significance was determined using a pre-specified threshold of 0.05.|Chi-squared|||In this pairwise analysis, the proportion of participants alive and with sCR/CR/VGPR will be compared between the vaccine arm and lenalidomide alone arm at 1 year Post Transplant.||||0.4930
72552608|NCT02728102|144636043|SUPERIORITY|||||||0.6591||||||Statistical significance was determined using a pre-specified threshold of 0.05.|Chi-squared|||In this pairwise analysis, the proportion of participants alive and with sCR/CR/VGPR will be compared between the lenalidomide/GM-CSF arm and lenalidomide alone arm at 1 year Post Transplant.||||0.6591
72552609|NCT02728102|144636043|SUPERIORITY|||||||0.679||||||Statistical significance was determined using a pre-specified threshold of 0.05|Chi-squared|||The proportion of participants alive and with sCR/CR/VGPR will be compared between the vaccine and the combined non-vaccine arms at 2 years Post Transplant.||||0.6790
72552610|NCT02728102|144636043|SUPERIORITY|||||||0.3124||||||Statistical significance was determined using a pre-specified threshold of 0.05.|Chi-squared|||In this pairwise analysis, the proportion of participants alive and with sCR/CR/VGPR will be compared between the vaccine arm and lenalidomide/GM-CSF arm at 2 years Post Transplant.||||0.3124
72329522|NCT00135330|144184480|SUPERIORITY_OR_OTHER|||||||0.117||95.0|||||MMRM|||||||0.117
72545677|NCT00294723|144620756|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg and glimepiride was calculated. If the upper limit of the 95% CI was below 0 mg/dL, it was concluded that the given dose of liraglutide was better than glimepiride.|Estimated treatment difference, LS Mean|-17.79||||0.0003||95.0|-27.48|-8.09||2-sided significance level 5%|ANCOVA|||Change in fasting plasma glucose (FPG) from baseline to end of treatment at 104 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline FPG as covariate.||-8.09|-27.48|0.0003
72545678|NCT00294723|144620756|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.2 mg and glimepiride was calculated. If the upper limit of the 95% CI was below 0 mg/dL, it was concluded that the given dose of liraglutide was better than glimepiride.|Estimated treatment difference, LS Mean|-11.33||||0.0217||95.0|-20.99|-1.66||2-sided significance level 5%|ANCOVA|||Change in fasting plasma glucose (FPG) from baseline to end of treatment at 104 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline FPG as covariate.||-1.66|-20.99|0.0217
72580143|NCT00535405|144689596|SUPERIORITY_OR_OTHER_LEGACY||Ratio of odds|1.67|STANDARD_ERROR_OF_MEAN|0.47||0.069||95.0|0.96|2.6||Reported p-value is multiplicity-adjusted. Hochberg procedure was used to adjust for multiple comparisons.|Logistic Regression using GEE|Model include terms for treatment, baseline LDL-C, study week and treatment by study week interaction.|Ratio of odds of achieving pre-specified LDL-C level on EZ/Simva versus Atorva|||2.60|0.96|0.069
72580144|NCT00535405|144689596|SUPERIORITY_OR_OTHER_LEGACY||Ratio of odds|1.78|STANDARD_ERROR_OF_MEAN|0.44||0.039|TWO_SIDED|95.0|1.1|2.9||Reported p-value is multiplicity-adjusted. Hochberg procedure was used to adjust for multiple comparisons.|Logistic Regression using GEE|Model include terms for treatment, baseline LDL-C, study week and treatment by study week interaction.|Ratio of odds of achieving pre-specified LDL-C level on EZ/Simva versus Atorva|||2.90|1.10|0.039
72580145|NCT03091179|144689611|EQUIVALENCE|P value was calculated using the means and standard deviations for each of the patient characteristics.||||||0.006|||||||t-test, 2 sided|||||||0.006
72580146|NCT02969044|144689624|SUPERIORITY||Mean Difference (Net)|-9.25|||<|0.001|TWO_SIDED|95.0|-14.75|-3.79|||ANCOVA|||||-3.79|-14.75|<0.001
72580147|NCT03164616|144689648|SUPERIORITY||Hazard Ratio (HR)|0.74||||0.00093|TWO_SIDED|95.0|0.62|0.885||Analysis was performed using a stratified log-rank test adjusting for PD-L1 tumor expression (TC ≥50% vs \<50%), histology (squamous vs non-squamous) and disease stage (IVA vs IVB) and using the Breslow approach for handling ties.|Log Rank||The HR and confidence interval (CI) were estimated from a stratified Cox proportional hazards model adjusting for PD-L1 (TC ≥50% vs \<50%), histology (squamous vs non-squamous) and disease stage (IVA vs IVB) and using Efron method to control for ties.|D + SoC vs SoC alone. A hazard ratio (HR) \<1 favors D + SoC to be associated with a longer PFS than SoC alone.||0.885|0.620|0.00093
72580148|NCT03164616|144689649|SUPERIORITY||Hazard Ratio (HR)|0.86||||0.07581|TWO_SIDED|95.0|0.724|1.016||Analysis was performed using a stratified log-rank test adjusting for PD-L1 tumor expression (TC ≥50% vs \<50%), histology (squamous vs non-squamous) and disease stage (IVA vs IVB) and using the Breslow approach for handling ties.|Log Rank||The HR and CI were estimated from a stratified Cox proportional hazards model adjusting for PD-L1 (TC ≥50% vs \<50%), histology (squamous vs non-squamous) and disease stage (IVA vs IVB) and using Efron method to control for ties.|D + SoC vs SoC alone. An HR \<1 favors D + SoC to be associated with a longer OS than SoC alone.||1.016|0.724|0.07581
72580149|NCT03164616|144689650|SUPERIORITY||Hazard Ratio (HR)|0.72||||0.00031|TWO_SIDED|95.0|0.6|0.86||Analysis was performed using a stratified log-rank test adjusting for PD-L1 tumor expression (TC ≥50% vs \<50%), histology (squamous vs non-squamous) and disease stage (IVA vs IVB) and using the Breslow approach for handling ties.|Log Rank||The HR and CI were estimated from a stratified Cox proportional hazards model adjusting for PD-L1 (TC ≥50% vs \<50%), histology (squamous vs non-squamous) and disease stage (IVA vs IVB) and using Efron method to control for ties.|T + D + SoC vs SoC alone. An HR \<1 favors T + D + SoC to be associated with a longer PFS than SoC alone.||0.860|0.600|0.00031
72580150|NCT03164616|144689651|SUPERIORITY||Hazard Ratio (HR)|0.77||||0.00304|TWO_SIDED|95.0|0.65|0.916||Analysis was performed using a stratified log-rank test adjusting for PD-L1 tumor expression (TC ≥50% vs \<50%), histology (squamous vs non-squamous) and disease stage (IVA vs IVB) and using the Breslow approach for handling ties.|Log Rank||The HR and CI were estimated from a stratified Cox proportional hazards model adjusting for PD-L1 (TC ≥50% vs \<50%), histology (squamous vs non-squamous) and disease stage (IVA vs IVB) and using Efron method to control for ties.|T + D + SoC vs SoC alone. An HR \<1 favors T + D + SoC to be associated with a longer OS than SoC alone.||0.916|0.650|0.00304
72580151|NCT03164616|144689652|SUPERIORITY||Odds Ratio (OR)|1.9|||||TWO_SIDED|95.0|1.382|2.619||||||D + SoC vs SoC alone. An odds ratio \>1 favors D + SoC compared to SoC alone. Analysis was performed using logistic regression adjusting for PD-L1 tumor expression (TC ≥50% vs \<50%), histology (squamous vs non-squamous) and disease stage (IVA vs IVB), with the CI calculated using a profile likelihood approach.||2.619|1.382|
72329523|NCT00135330|144184481|SUPERIORITY_OR_OTHER|||||||0.251||95.0|||||MMRM|||||||0.251
72545679|NCT00294723|144620756|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg and liraglutide 1.2 mg was calculated. If the upper limit of the 95% CI was below 0 mg/dL, it was concluded that liraglutide 1.8 mg was better than liraglutide 1.2 mg|Estimated treatment difference, LS Mean|-6.46||||0.1942||95.0|-16.23|3.3||2-sided significance level 5%|ANCOVA|||Change in fasting plasma glucose (FPG) from baseline to end of treatment at 104 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline FPG as covariate.||3.30|-16.23|0.1942
72580152|NCT03164616|144689652|SUPERIORITY||Odds Ratio (OR)|1.72|||||TWO_SIDED|95.0|1.26|2.367||||||T + D + SoC vs SoC alone. An odds ratio \>1 favors T + D + SoC compared to SoC alone. Analysis was performed using logistic regression adjusting for PD-L1 tumor expression (TC ≥50% vs TC \<50%), histology (squamous vs non-squamous) and disease stage (IVA vs IVB), with the CI calculated using a profile likelihood approach.||2.367|1.260|
72580153|NCT03164616|144689655|SUPERIORITY||Hazard Ratio (HR)|0.79|||||TWO_SIDED|95.0|0.666|0.928|||||The HR and CI were estimated from a stratified Cox proportional hazards model adjusting for PD-L1 (TC ≥50% vs \<50%), histology (squamous vs non-squamous) and disease stage (IVA vs IVB) and using Efron method to control for ties.|D + SoC vs SoC alone. An HR \<1 favors D + SoC to be associated with a longer PFS2 than SoC alone.||0.928|0.666|
72580154|NCT03164616|144689655|SUPERIORITY||Hazard Ratio (HR)|0.75|||||TWO_SIDED|95.0|0.632|0.883|||||The HR and CI were estimated from a stratified Cox proportional hazards model adjusting for PD-L1 (TC ≥50% vs \<50%), histology (squamous vs non-squamous) and disease stage (IVA vs IVB) and using Efron method to control for ties.|T + D + SoC vs SoC alone. An HR \<1 favors T + D + SoC to be associated with a longer PFS2 than SoC alone.||0.883|0.632|
72580155|NCT01328184|144689672|NON_INFERIORITY_OR_EQUIVALENCE|Ratio calculated as Microgynon plus empa divided by Microgynon|Geometric Mean Ratio|102.82|STANDARD_DEVIATION|9.0|||TWO_SIDED|90.0|97.58|108.35|||ANOVA|Based on ANOVA with fixed term for treatment and random term for subject.|Standard deviation is actually the geometric coefficient of variation (gCV)|No formal testing, investigation of relative bioavailability.||108.35|97.58|
72580156|NCT01328184|144689673|NON_INFERIORITY_OR_EQUIVALENCE|Ratio calculated as Microgynon plus empa divided by Microgynon|Geometric Mean Ratio|101.94|STANDARD_DEVIATION|5.9|||TWO_SIDED|90.0|98.54|105.47|||ANOVA|Based on ANOVA with fixed term for treatment and random term for subject.|Standard deviation is actually the geometric coefficient of variation (gCV)|No formal testing, investigation of relative bioavailability.||105.47|98.54|
72580157|NCT01328184|144689674|NON_INFERIORITY_OR_EQUIVALENCE|Ratio calculated as Microgynon plus empa divided by Microgynon|Geometric Mean Ratio|99.22|STANDARD_DEVIATION|10.4|||TWO_SIDED|90.0|93.4|105.39|||ANOVA|Based on ANOVA with fixed term for treatment and random term for subject.|Standard deviation is actually the geometric coefficient of variation (gCV).|No formal testing, investigation of relative bioavailability.||105.39|93.40|
72580158|NCT01328184|144689675|NON_INFERIORITY_OR_EQUIVALENCE|Ratio calculated as Microgynon plus empa divided by Microgynon|Geometric Mean Ratio|105.81|STANDARD_DEVIATION|10.7|||TWO_SIDED|90.0|99.47|112.55|||ANOVA|Based on ANOVA with fixed term for treatment and random term for subject.|Standard deviation is actually the geometric coefficient of variation (gCV)|No formal testing, investigation of relative bioavailability.||112.55|99.47|
72580159|NCT01959295|144689704|SUPERIORITY|||||||0.5086|||||||Mantel Haenszel|||The superiority of ASP2151 200mg to ASP2151 placebo was assessed by Mantel-Haenszel method, adjusted by disease type (labial/facial herpes and recurrent genital herpes) .||||0.5086
72580160|NCT04917861|144689713|OTHER||Geometric Mean Ratio (GMR)|7.002|||||TWO_SIDED|95.0|5.451|8.992|||||GMR (mRNA-1893 Low Dose \[2-Dose Regimen\] vs. Placebo) for all participants|||8.992|5.451|
72580161|NCT04917861|144689713|OTHER||GMR|7.123|||||TWO_SIDED|95.0|5.467|9.279|||||GMR (mRNA-1893 High Dose \[2-Dose Regimen\] vs. Placebo) for all participants|||9.279|5.467|
72580162|NCT04917861|144689713|OTHER||GMR|2.674|||||TWO_SIDED|95.0|1.961|3.646|||||GMR (mRNA-1893 High Dose \[1-Dose Regimen\] vs. Placebo) for all participants|||3.646|1.961|
72580163|NCT04917861|144689713|OTHER||GMR|7.208|||||TWO_SIDED|95.0|5.428|9.571|||||GMR (mRNA-1893 Low Dose \[2-Dose Regimen\] vs. Placebo) for flavivirus-seronegative participants|||9.571|5.428|
72580164|NCT04917861|144689713|OTHER||GMR|7.979|||||TWO_SIDED|95.0|6.106|10.425|||||GMR (mRNA-1893 High Dose \[2-Dose Regimen\] vs. Placebo) for flavivirus-seronegative participants|||10.425|6.106|
72580165|NCT04917861|144689713|OTHER||GMR|1.516|||||TWO_SIDED|95.0|1.229|1.869|||||GMR (mRNA-1893 High Dose \[1-Dose Regimen\] vs. Placebo) for flavivirus-seronegative participants|||1.869|1.229|
72580166|NCT04917861|144689713|OTHER||GMR|6.785|||||TWO_SIDED|95.0|4.562|10.092|||||GMR (mRNA-1893 Low Dose \[2-Dose Regimen\] vs. Placebo) for flavivirus-seropositive participants|||10.092|4.562|
72580167|NCT04917861|144689713|OTHER||GMR|6.319|||||TWO_SIDED|95.0|4.03|9.909|||||GMR (mRNA-1893 High Dose \[2-Dose Regimen\] vs. Placebo) for flavivirus-seropositive participants|||9.909|4.030|
72580168|NCT04917861|144689713|OTHER||GMR|7.028|||||TWO_SIDED|95.0|4.056|12.18|||||GMR (mRNA-1893 High Dose \[1-Dose Regimen\] vs. Placebo) for flavivirus-seropositive participants|||12.180|4.056|
72580169|NCT04917861|144689714|OTHER||GMR|5.312|||||TWO_SIDED|95.0|4.149|6.802|||||GMR (mRNA-1893 Low Dose \[2-Dose Regimen\] vs. Placebo) for all participants|||6.802|4.149|
72580170|NCT04917861|144689714|OTHER||GMR|5.346|||||TWO_SIDED|95.0|4.128|6.922|||||GMR (mRNA-1893 High Dose \[2-Dose Regimen\] vs. Placebo) for all participants|||6.922|4.128|
72580171|NCT04917861|144689714|OTHER||GMR|2.325|||||TWO_SIDED|95.0|1.721|3.14|||||GMR (mRNA-1893 High Dose \[1-Dose Regimen\] vs. Placebo) for all participants|||3.140|1.721|
72580172|NCT04917861|144689714|OTHER||GMR|4.221|||||TWO_SIDED|95.0|3.322|5.363|||||GMR (mRNA-1893 Low Dose \[2-Dose Regimen\] vs. Placebo) for flavivirus-negative participants|||5.363|3.322|
72580173|NCT04917861|144689714|OTHER||GMR|5.3|||||TWO_SIDED|95.0|4.243|6.62|||||GMR (mRNA-1893 High Dose \[2-Dose Regimen\] vs. Placebo) for flavivirus-negative participants|||6.620|4.243|
72580174|NCT04917861|144689714|OTHER||GMR|1.206|||||TWO_SIDED|95.0|1.033|1.407|||||GMR (mRNA-1893 High Dose \[1-Dose Regimen\] vs. Placebo) for flavivirus-negative participants|||1.407|1.033|
72580175|NCT04917861|144689714|OTHER||GMR|6.493|||||TWO_SIDED|95.0|4.358|9.674|||||GMR (mRNA-1893 Low Dose \[2-Dose Regimen\] vs. Placebo) for flavivirus-positive participants|||9.674|4.358|
72580176|NCT04917861|144689714|OTHER||GMR|5.452|||||TWO_SIDED|95.0|3.43|8.665|||||GMR (mRNA-1893 High Dose \[2-Dose Regimen\] vs. Placebo) for flavivirus-positive participants|||8.665|3.430|
72580177|NCT04917861|144689714|OTHER||GMR|6.804|||||TWO_SIDED|95.0|3.928|11.784|||||GMR (mRNA-1893 High Dose \[1-Dose Regimen\] vs. Placebo) for flavivirus-positive participants|||11.784|3.928|
72580178|NCT04917861|144689715|OTHER||percentage difference|76.69|||||TWO_SIDED|95.0|69.1|82.68|||||Percentage Difference (mRNA-1893 Low Dose \[2-Dose Regimen\] vs. Placebo) for all participants|||82.68|69.10|
72411768|NCT00406029|144331708|SUPERIORITY_OR_OTHER||Difference in LS Means|0.1||||0.786|TWO_SIDED|95.0|-0.5|0.7|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.7|-0.5|0.786
72545680|NCT00294723|144620757|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg and glimepiride was calculated. If the upper limit of the 95% CI was below 0 mg/dL, it was concluded that the given dose of liraglutide was better than glimepiride.|Estimated treatment difference, LS Mean|-16.63||||0.0007||95.0|-26.19|-7.06||2-sided significance level 5%|ANCOVA|||Change in fasting plasma glucose (FPG) from baseline to end of treatment at 156 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline FPG as covariate.||-7.06|-26.19|0.0007
72545681|NCT00294723|144620757|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.2 mg and glimepiride was calculated. If the upper limit of the 95% CI was below 0 mg/dL, it was concluded that the given dose of liraglutide was better than glimepiride.|Estimated treatment difference, LS Mean|-10.02||||0.0395||95.0|-19.56|-0.49||2-sided significance level 5%|ANCOVA|||Change in fasting plasma glucose (FPG) from baseline to end of treatment at 156 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline FPG as covariate.||-0.49|-19.56|0.0395
72580179|NCT04917861|144689715|OTHER||percentage difference|77.8|||||TWO_SIDED|95.0|70.29|83.67|||||Percentage Difference (mRNA-1893 High Dose \[2-Dose Regimen\] vs. Placebo) for all participants|||83.67|70.29|
72580180|NCT04917861|144689715|OTHER||percentage difference|35.58|||||TWO_SIDED|95.0|27.47|43.74|||||Percentage Difference (mRNA-1893 High Dose \[1-Dose Regimen\] vs. Placebo) for all participants|||43.74|27.47|
72580181|NCT04917861|144689715|OTHER||percentage difference|86.11|||||TWO_SIDED|95.0|76.25|92.29|||||Percentage Difference (mRNA-1893 Low Dose \[2-Dose Regimen\] vs. Placebo) for flavivirus-negative participants|||92.29|76.25|
72580182|NCT04917861|144689715|OTHER||percentage difference|87.65|||||TWO_SIDED|95.0|78.71|93.17|||||Percentage Difference (mRNA-1893 High Dose \[2-Dose Regimen\] vs. Placebo) for flavivirus-negative participants|||93.17|78.71|
72580183|NCT04917861|144689715|OTHER||percentage difference|20.43|||||TWO_SIDED|95.0|13.47|29.75|||||Percentage Difference (mRNA-1893 High Dose \[1-Dose Regimen\] vs. Placebo) for flavivirus-negative participants|||29.75|13.47|
72580184|NCT04917861|144689715|OTHER||percentage difference|67.72|||||TWO_SIDED|95.0|55.69|77.07|||||Percentage Difference (mRNA-1893 Low Dose \[2-Dose Regimen\] vs. Placebo) for flavivirus-positive participants|||77.07|55.69|
72580185|NCT04917861|144689715|OTHER||percentage difference|67.81|||||TWO_SIDED|95.0|55.36|77.44|||||Percentage Difference (mRNA-1893 High Dose \[2-Dose Regimen\] vs. Placebo) for flavivirus-positive participants|||77.44|55.36|
72580186|NCT04917861|144689715|OTHER||percentage difference|57.53|||||TWO_SIDED|95.0|43.81|69.08|||||Percentage Difference (mRNA-1893 High Dose \[1-Dose Regimen\] vs. Placebo) for flavivirus-positive participants|||69.08|43.81|
72580187|NCT04917861|144689716|OTHER||percentage difference|75.46|||||TWO_SIDED|95.0|68.12|81.49|||||Percentage Difference (mRNA-1893 Low Dose \[2-Dose Regimen\] vs. Placebo) for all participants|||81.49|68.12|
72580188|NCT04917861|144689716|OTHER||percentage difference|75.32|||||TWO_SIDED|95.0|67.94|81.38|||||Percentage Difference (mRNA-1893 High Dose \[2-Dose Regimen\] vs. Placebo) for all participants|||81.38|67.94|
72545682|NCT00294723|144620757|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg and liraglutide 1.2 mg was calculated. If the upper limit of the 95% CI was below 0 mg/dL, it was concluded that liraglutide 1.8 mg was better than liraglutide 1.2 mg.|Estimated treatment difference, LS Mean|-6.6||||0.1789||95.0|-16.24|3.03||2-sided significance level 5%|ANCOVA|||Change in fasting plasma glucose (FPG) from baseline to end of treatment at 156 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline FPG as covariate.||3.03|-16.24|0.1789
72580189|NCT04917861|144689716|OTHER||percentage difference|31.29|||||TWO_SIDED|95.0|24.23|38.96|||||Percentage Difference (mRNA-1893 High Dose \[1-Dose Regimen\] vs. Placebo) for all participants|||38.96|24.23|
72580190|NCT04917861|144689716|OTHER||percentage difference|77.78|||||TWO_SIDED|95.0|66.87|85.85|||||Percentage Difference (mRNA-1893 Low Dose \[2-Dose Regimen\] vs. Placebo) for flavivirus-negative participants|||85.85|66.87|
72580191|NCT04917861|144689716|OTHER||percentage difference|82.72|||||TWO_SIDED|95.0|73.02|89.43|||||Percentage Difference (mRNA-1893 High Dose \[2-Dose Regimen\] vs. Placebo) for flavivirus-negative participants|||89.43|73.02|
72580192|NCT04917861|144689716|OTHER||percentage difference|9.68|||||TWO_SIDED|95.0|4.63|17.41|||||Percentage Difference (mRNA-1893 High Dose \[1-Dose Regimen\] vs. Placebo) for flavivirus-negative participants|||17.41|4.63|
72580193|NCT04917861|144689716|OTHER||percentage difference|72.39|||||TWO_SIDED|95.0|61.56|80.83|||||Percentage Difference (mRNA-1893 Low Dose \[2-Dose Regimen\] vs. Placebo) for flavivirus-positive participants|||80.83|61.56|
72580194|NCT04917861|144689716|OTHER||percentage difference|67.29|||||TWO_SIDED|95.0|55.72|76.78|||||Percentage Difference (mRNA-1893 High Dose \[2-Dose Regimen\] vs. Placebo) for flavivirus-positive participants|||76.78|55.72|
72580195|NCT04917861|144689716|OTHER||percentage difference|63.35|||||TWO_SIDED|95.0|50.75|74.0|||||Percentage Difference (mRNA-1893 High Dose \[1-Dose Regimen\] vs. Placebo) for flavivirus-positive participants|||74.00|50.75|
72580196|NCT06389487|144689730|NON_INFERIORITY|Non-Inferiority (NI) was to be demonstrated if the upper limit of the 95% confidence interval (CI) of the group GMT ratio between Part A:RSV-OA Group over Part A:RSV-A-AIR Group at 1 month post RSVPreF3 OA vaccine administration was less than or equal to (≤) 1.5.|GMT Ratio|0.72|||||TWO_SIDED|95.0|0.64|0.81|||||The comparison is done using the group ratio of adjusted GMT (Part A:RSV-OA/ Part A:RSV-A-AIR) (ANCOVA model applied to the log10- transformed titers). The ANCOVA model included the group as fixed effects and the pre-dose log-10 titer as covariate.|To demonstrate the non-inferiority of the humoral immune response in participants aged 18-49 YOA at increased risk for RSV disease (Part A:RSV-A-AIR Group) compared to older adults aged ≥60 YOA (Part A:RSV-OA Group) for the RSV-A strain after RSVPreF3 OA investigational vaccine administration.||0.81|0.64|
72580197|NCT06389487|144689731|NON_INFERIORITY|NI was to be demonstrated if the upper limit of the 95% CI of the group SRR difference between Part A:RSV-OA Group and Part A:RSV-A-AIR Group at 1 month post RSVPreF3 OA vaccine administration was ≤10%.|Difference in percentage|-9.33|||||TWO_SIDED|95.0|-14.55|-4.1|||||The comparison is done using the difference of SRR (Part A:RSV-OA - Part A:RSV-A-AIR).|To demonstrate the non-inferiority of the humoral immune response in participants aged 18-49 YOA at increased risk for RSV disease (Part A:RSV-A-AIR Group) compared to older adults aged ≥60 YOA (Part A:RSV-OA Group) for the RSV-A strain after RSVPreF3 OA investigational vaccine administration.||-4.10|-14.55|
72580198|NCT06389487|144689732|NON_INFERIORITY|NI was to be demonstrated if the upper limit of the 95% CI of the group GMT ratio between Part A:RSV-OA Group over Part A:RSV-A-AIR Group at 1 month post RSVPreF3 OA vaccine administration was ≤1.5.|GMT Ratio|0.73|||||TWO_SIDED|95.0|0.65|0.82|||||The comparison is done using the group ratio of adjusted GMT (Part A:RSV-OA/ Part A:RSV-A-AIR) (ANCOVA model applied to the log10- transformed titers). The ANCOVA model included the group as fixed effects and the pre-dose log-10 titer as covariate.|To demonstrate the non-inferiority of the humoral immune response in participants aged 18-49 YOA at increased risk for RSV disease (Part A:RSV-A-AIR Group) compared to older adults aged ≥60 YOA (Part A:RSV-OA Group) for the RSV-B strain after RSVPreF3 OA investigational vaccine administration.||0.82|0.65|
72545683|NCT00294723|144620758|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg and glimepiride was calculated. If the upper limit of the 95% CI was below 0 mg/dL, it was concluded that the given dose of liraglutide was better than glimepiride.|Estimated treatment difference, LS Mean|-12.9||||0.0038||95.0|-21.6|-4.2||2-sided significance level 5%|ANCOVA|||Change in mean postprandial glucose (PPG) from baseline to end of treatment at 52 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline PPG as covariate.||-4.2|-21.6|0.0038
72545684|NCT00294723|144620758|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.2 mg and glimepiride was calculated. If the upper limit of the 95% CI was below 0 mg/dL, it was concluded that the given dose of liraglutide was better than glimepiride.|Estimated treatment difference, LS Mean|-6.3||||0.1616||95.0|-15.0|2.5||2-sided significance level 5%|ANCOVA|||Change in postprandial glucose (PPG) from baseline to end of treatment at 52 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline PPG as covariate.||2.5|-15.0|0.1616
72580199|NCT06389487|144689733|NON_INFERIORITY|NI was to be demonstrated if the upper limit of the 95% CI of the group SRR difference between Part A:RSV-OA Group and Part A:RSV-A-AIR Group at 1 month post RSVPreF3 OA vaccine administration was ≤10%.|Difference in percentage|-10.03|||||TWO_SIDED|95.0|-15.26|-4.8|||||The comparison is done using the difference of SRR (Part A:RSV-OA - Part A:RSV-A-AIR).|To demonstrate the non-inferiority of the humoral immune response in participants aged 18-49 YOA at increased risk for RSV disease (Part A:RSV-A-AIR Group) compared to older adults aged ≥60 YOA (Part A:RSV-OA Group) for the RSV-B strain after RSVPreF3 OA investigational vaccine administration.||-4.80|-15.26|
72580200|NCT04479852|144689768|SUPERIORITY||Mean Difference (Final Values)|-1.8||||0.133|TWO_SIDED|95.0|-4.1|0.5|||Mixed Models Analysis||A negative difference favors the SP-624 treatment group, i.e., a greater reduction in MADRS score from baseline.|||0.5|-4.1|0.133
72580201|NCT04479852|144689769|SUPERIORITY||Mean Difference (Final Values)|-0.3||||0.059|TWO_SIDED|95.0|-0.5|0.0|||Mixed Models Analysis||A negative difference favors the SP-624 treatment group, i.e., a greater reduction in CGI-S score from baseline.|||0.0|-0.5|0.059
72580202|NCT04479852|144689770|SUPERIORITY||Mean Difference (Final Values)|-1.1||||0.159|TWO_SIDED|95.0|-2.7|0.4|||Mixed Models Analysis||A negative difference favors the SP-624 treatment group, i.e., a greater reduction in HAM-D score from baseline.|||0.4|-2.7|0.159
72580203|NCT04479852|144689771|SUPERIORITY||Mean Difference (Final Values)|-1.0||||0.188|TWO_SIDED|95.0|-2.5|0.5|||Mixed Models Analysis||A negative difference favors the SP-624 treatment group, i.e., a greater reduction in SDS score from baseline.|||0.5|-2.5|0.188
72329524|NCT00135330|144184482|SUPERIORITY_OR_OTHER|||||||0.71||95.0|||||MMRM|||||||0.710
72329525|NCT00135330|144184483|SUPERIORITY_OR_OTHER|||||||0.575||95.0|||||Fisher Exact|||||||0.575
72580204|NCT04479852|144689772|SUPERIORITY||Mean Difference (Final Values)|-0.9||||0.091|TWO_SIDED|95.0|-2.0|0.2|||Mixed Models Analysis||A negative difference favors the SP-624 treatment group, i.e., a greater reduction in QIDS score from baseline.|||0.2|-2.0|0.091
72580205|NCT04479852|144689773|SUPERIORITY||Mean Difference (Final Values)|1.7||||0.243|TWO_SIDED|95.0|-1.2|4.6|||Mixed Models Analysis||A positive difference favors the SP-624 treatment group, i.e., a greater increase in Q-LES-Q score from baseline.|||4.6|-1.2|0.243
72580206|NCT04479852|144689774|SUPERIORITY||Mean Difference (Final Values)|-3.9||||0.008|TWO_SIDED|95.0|-6.8|-1.0|||Mixed Models Analysis||A negative difference favors the SP-624 treatment group, i.e., a greater reduction in MADRS score from baseline.|||-1.0|-6.8|.008
72545685|NCT00294723|144620758|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg and liraglutide 1.2 mg was calculated. If the upper limit of the 95% CI was below 0 mg/dL, it was concluded that liraglutide 1.8 mg was better than liraglutide 1.2 mg.|Estimated treatment difference, LS Mean|-6.6||||0.1319||95.0|-15.3|2.0||2-sided significance level 5%|ANCOVA|||Change in postprandial glucose (PPG) from baseline to end of treatment at 52 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline PPG as covariate.||2.0|-15.3|0.1319
72545686|NCT00294723|144620759|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg and glimepiride was calculated. If the upper limit of the 95% CI was below 0 mg/dL, it was concluded that the given dose of liraglutide was better than glimepiride.|Estimated treatment difference, LS Mean|-12.3||||0.0105||95.0|-21.71|-2.89||2-sided significance level 5%|ANCOVA|||Change in postprandial glucose (PPG) from baseline to end of treatment at 104 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline PPG as covariate.||-2.89|-21.71|0.0105
72545687|NCT00294723|144620759|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.2 mg and glimepiride was calculated. If the upper limit of the 95% CI was below 0 mg/dL, it was concluded that the given dose of liraglutide was better than glimepiride.|Estimated treatment difference, LS Mean|-2.49||||0.606||95.0|-11.95|6.98||2-sided significance level 5%|ANCOVA|||Change in postprandial glucose (PPG) from baseline to end of treatment at 104 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline PPG as covariate.||6.98|-11.95|0.6060
72580207|NCT04479852|144689775|SUPERIORITY||Mean Difference (Final Values)|-0.5||||0.006|TWO_SIDED|95.0|-0.8|-0.1|||Mixed Models Analysis||A negative difference favors the SP-624 treatment group, i.e., a greater reduction in CGI-S score from baseline.|||-0.1|-0.8|0.006
72580208|NCT04479852|144689776|SUPERIORITY||Mean Difference (Final Values)|2.7||||0.134|TWO_SIDED|95.0|-0.8|6.3|||Mixed Models Analysis||A negative difference favors the SP-624 treatment group, i.e., a greater reduction in MADRS score from baseline.|||6.3|-0.8|0.134
72580209|NCT04479852|144689777|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.437|TWO_SIDED|95.0|-0.3|0.6|||Mixed Models Analysis||A negative difference favors the SP-624 treatment group, i.e., a greater reduction in CGI-S score from baseline.|||0.6|-0.3|0.437
72580210|NCT02366689|144689802|SUPERIORITY_OR_OTHER|||||||0.04|TWO_SIDED||||||ANOVA|||The null hypothesis states that there is no difference between groups.||||0.04
72580211|NCT02366689|144689803|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||< 0.001
72580212|NCT02366689|144689804|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||<0.001
72580213|NCT02366689|144689805|SUPERIORITY_OR_OTHER|||||||0.432|TWO_SIDED||||||ANOVA|||The null hypothesis states that there is no difference between groups.||||0.432
72580214|NCT02366689|144689806|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||<0.001
72580215|NCT02366689|144689807|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||<0.001
72580216|NCT03283566|144689809|EQUIVALENCE|Assuming a 20-30% difference in outcome (CP/G quotient) between study arms, which is equivalent to 0.08-0.12 CP/G difference and a 0.07 standard deviation, a sample size of 6 subjects (1:1 randomization) will detect a CP/G difference of at least 0.12, assuming 80% power, with a 0.05 significance level.||||||0.739|||||||ANOVA|||||||0.739
72329526|NCT00135330|144184484|SUPERIORITY_OR_OTHER|||||||0.436||95.0|||||ANOVA|||||||0.436
72329527|NCT00135330|144184485|SUPERIORITY_OR_OTHER|||||||0.168||95.0|||||Generalized Linear Model|||||||0.168
72329528|NCT03517371|144184511|SUPERIORITY||Mean Difference (Final Values)|72.35||||0.89|TWO_SIDED|95.0|-943.34|1088.04|||t-test, 2 sided|||||1088.04|-943.34|.89
72545688|NCT00294723|144620759|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg and liraglutide 1.2 mg was calculated. If the upper limit of the 95% CI was below 0 mg/dL, it was concluded that liraglutide 1.8 mg was better than liraglutide 1.2 mg.|Estimated treatment difference, LS Mean|-9.81||||0.0392||95.0|-19.14|-0.49||2-sided significance level 5%|ANCOVA|||Change in postprandial glucose (PPG) from baseline to end of treatment at 104 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline PPG as covariate.||-0.49|-19.14|0.0392
72411769|NCT00406029|144331708|SUPERIORITY_OR_OTHER||Difference in LS Means|0.1||||0.702|TWO_SIDED|95.0|-0.5|0.7|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.7|-0.5|0.702
72411770|NCT00406029|144331708|SUPERIORITY_OR_OTHER||Difference in LS Means|0.3||||0.371|TWO_SIDED|95.0|-0.3|0.9|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.9|-0.3|0.371
72411771|NCT00406029|144331708|SUPERIORITY_OR_OTHER||Difference in LS Means|0.0||||0.981|TWO_SIDED|95.0|-0.6|0.6|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.6|-0.6|0.981
72545689|NCT00294723|144620760|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg and glimepiride was calculated. If the upper limit of the 95% CI was below 0 mg/dL, it was concluded that the given dose of liraglutide was better than glimepiride.|Estimated treatment difference, LS Mean|-10.98||||0.0227||95.0|-20.42|-1.54||2-sided significance level 5%|ANCOVA|||Change in postprandial glucose (PPG) from baseline to end of treatment at 156 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline PPG as covariate.||-1.54|-20.42|0.0227
72545690|NCT00294723|144620760|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.2 mg and glimepiride was calculated. If the upper limit of the 95% CI was below 0 mg/dL, it was concluded that the given dose of liraglutide was better than glimepiride.|Estimated treatment difference, LS Mean|-1.83||||0.7047||95.0|-11.33|7.66||2-sided significance level 5%|ANCOVA|||Change in postprandial glucose (PPG) from baseline to end of treatment at 156 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline PPG as covariate.||7.66|-11.33|0.7047
72545691|NCT00294723|144620760|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg and liraglutide 1.2 mg was calculated. If the upper limit of the 95% CI was below 0 mg/dL, it was concluded that liraglutide 1.8 mg was better than liraglutide 1.2 mg.|Estimated treatment difference, LS Mean|-9.15||||0.0553||95.0|-18.51|0.21||2-sided significance level 5%|ANCOVA|||Change in postprandial glucose (PPG) from baseline to end of treatment at 156 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline PPG as covariate.||0.21|-18.51|0.0553
72545692|NCT00294723|144620761|NON_INFERIORITY_OR_EQUIVALENCE|The two-sided 95% confidence interval (CI) for the treatment difference \[liraglutide - glimepiride\] was estimated. Liraglutide was shown to be non-inferior to glimepiride if the upper limit of the two-sided 95% CI for the treatment difference was below 0.4% and superior if the complete CI was below 0%.|Estimated treatment difference, LS Mean|-0.55|||<|0.0001||95.0|-0.77|-0.34||The statistical analysis of the primary endpoint was done in a hierarchal manner due to multiple comparisons. No other adjustments were made for multiplicity. 2-sided significance level was 5%.|ANCOVA|||Change in glycosylated haemoglobin (HbA1c) from baseline to end of treatment at 156 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country, and previous oral antidiabetic drug (OAD) treatment as fixed effects and baseline HbA1c as covariate.||-0.34|-0.77|<0.0001
72545693|NCT00294723|144620761|NON_INFERIORITY_OR_EQUIVALENCE|The two-sided 95% confidence interval (CI) for the treatment difference \[liraglutide - glimepiride\] was estimated. Liraglutide was shown to be non-inferior to glimepiride if the upper limit of the two-sided 95% CI for the treatment difference was below 0.4% and superior if the complete CI was below 0%. Superiority of 1.2 mg liraglutide was only tested if 1.2 mg liraglutide was non-inferior to glimepiride and 1.8 mg liraglutide was superior to glimepiride.|Estimated treatment difference, LS Mean|-0.28||||0.0122||95.0|-0.49|-0.06||The statistical analysis of the primary endpoint was done in a hierarchal manner due to multiple comparisons. No other adjustments were made for multiplicity. 2-sided significance level was 5%.|ANCOVA|||Change in glycosylated haemoglobin (HbA1c) from baseline to end of treatment at 156 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country, and previous oral antidiabetic drug (OAD) treatment as fixed effects and baseline HbA1c as covariate.||-0.06|-0.49|0.0122
72580217|NCT04882241|144689824|OTHER||Hazard Ratio (HR)|0.92||||0.39528|TWO_SIDED|95.0|0.5|1.7||One-sided p-value based on log-rank test|Log Rank||Based on Cox regression model with Efron's method of tie handling with treatment as a covariate.|||1.70|0.50|0.39528
72580218|NCT04882241|144689825|OTHER||Difference in Percentage|1.9||||0.33244|TWO_SIDED|95.0|-7.7|12.0|||Miettinen and Nurminen|Based on unstratified Miettinen \& Nurminen method||||12.0|-7.7|0.33244
72580219|NCT04882241|144689826|OTHER||Hazard Ratio (HR)|1.03||||0.52903|TWO_SIDED|95.0|0.48|2.22||One-sided p-value based on log-rank test|Log Rank||Based on Cox regression model with Efron's method of tie handling with treatment as a covariate|||2.22|0.48|0.52903
72580220|NCT04882241|144689831|OTHER||Hazard Ratio (HR)|0.83||||0.34632|TWO_SIDED|95.0|0.34|2.05||One-sided p-value based on log-rank test|Log Rank||Based on Cox regression model with Efron's method of tie handling with treatment as a covariate|||2.05|0.34|0.34632
72580221|NCT02543944|144689838|SUPERIORITY||Risk Ratio (RR)|-0.0944|STANDARD_ERROR_OF_MEAN|0.32||0.77|TWO_SIDED|95.0|-0.72|0.53|||Regression, Logistic|||||0.53|-0.72|0.77
72580222|NCT02543944|144689839|SUPERIORITY||Odds Ratio (OR)|0.3||||0.58|TWO_SIDED||||||Chi-squared|||||||0.58
72580223|NCT02543944|144689840|SUPERIORITY||Odds Ratio (OR)|0.16||||0.69|TWO_SIDED||||||Chi-squared|||||||0.69
72580224|NCT02543944|144689841|SUPERIORITY||Odds Ratio (OR)|0.96||||0.32|TWO_SIDED||||||Chi-squared|||||||0.32
72580225|NCT05262387|144689851|OTHER||Mean Difference (Final Values)|9.32||||0.0494|TWO_SIDED|90.0|1.52|17.1|||Mixed Models Analysis|||||17.1|1.52|0.0494
72329529|NCT03517371|144184512|SUPERIORITY||Mean Difference (Final Values)|-0.35||||0.42|TWO_SIDED|95.0|-3.8|3.1|||t-test, 2 sided|||||3.10|-3.80|.42
72411772|NCT00406029|144331708|SUPERIORITY_OR_OTHER||Difference in LS Means|0.3||||0.282|TWO_SIDED|95.0|-0.3|0.9|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.9|-0.3|0.282
72411773|NCT00406029|144331708|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.2||||0.55|TWO_SIDED|95.0|-0.7|0.4|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.4|-0.7|0.550
72411774|NCT00406029|144331708|SUPERIORITY_OR_OTHER||Difference in LS Means|0.1||||0.72|TWO_SIDED|95.0|-0.5|0.7|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.7|-0.5|0.720
72580226|NCT05262387|144689851|OTHER||Mean Difference (Final Values)|14.1||||0.0028|TWO_SIDED|90.0|6.38|21.9|||Mixed Models Analysis|||||21.9|6.38|0.0028
72580227|NCT05262387|144689852|OTHER||Mean Difference (Final Values)|-44.5||||0.1998|TWO_SIDED|90.0|-102.0|12.8|||Mixed Models Analysis|||||12.8|-102|0.1998
72580228|NCT05262387|144689852|OTHER||Mean Difference (Final Values)|4.16||||0.9041|TWO_SIDED|90.0|-53.1|61.4|||Mixed Models Analysis|||||61.4|-53.1|0.9041
72580229|NCT02515331|144689855|SUPERIORITY||Mean Difference (Net)|-8.555|STANDARD_ERROR_OF_MEAN|2.9077||0.002|TWO_SIDED|95.0|-14.388|-2.722||1-sided p-value|Longitudinal repeated measures mixed eff|||||-2.722|-14.388|0.002
72580230|NCT02515331|144689855|SUPERIORITY||Mean Difference (Net)|-14.727|STANDARD_ERROR_OF_MEAN|3.0548|<|0.001|TWO_SIDED|95.0|-20.852|-8.602||1-sided p-value|Longitudinal repeated measures mixed eff|||||-8.602|-20.852|<0.001
72580231|NCT01339403|144689931|SUPERIORITY_OR_OTHER||Rate ratio|166.1|||<|0.001|TWO_SIDED|95.0|123.4|223.5|||Poisson Regression|||Kaposi's sarcoma: Poisson regression models were used to analyze rates of clinical events by HIV and unadjusted incidence rate ratios compared risk in HIV-uninfected persons to HIV-infected persons.||223.5|123.4|<0.001
72580232|NCT01339403|144689931|SUPERIORITY_OR_OTHER||Rate ratio|12.1|||<|0.001|TWO_SIDED|95.0|10.3|14.2|||Poisson Regression|||Invasive non-Hodgkin's lymphoma: Poisson regression models were used to analyze rates of clinical events by HIV and unadjusted incidence rate ratios compared risk in HIV-uninfected persons to HIV-infected persons.||14.2|10.3|<0.001
72580233|NCT01339403|144689931|SUPERIORITY_OR_OTHER||Rate ratio|3.4||||0.059|TWO_SIDED|95.0|1.0|12.3|||Poisson Regression|||Invasive cervical cancer: Poisson regression models were used to analyze rates of clinical events by HIV and unadjusted incidence rate ratios compared risk in HIV-uninfected persons to HIV-infected persons.||12.3|1.0|0.059
72580234|NCT01339403|144689931|SUPERIORITY_OR_OTHER||Rate ratio|1.7|||<|0.001|TWO_SIDED|95.0|1.5|1.8|||Poisson Regression|||Non-AIDS-defining cancers: Poisson regression models were used to analyze rates of clinical events by HIV and unadjusted incidence rate ratios compared risk in HIV-uninfected persons to HIV-infected persons.||1.8|1.5|<0.001
72580235|NCT01339403|144689931|SUPERIORITY_OR_OTHER||Rate Ratio|166.1|||<|0.001|TWO_SIDED|95.0|123.4|223.5|||Poisson Regression|||AIDS-defining cancer: Poisson regression models were used to analyze rates of clinical events by HIV and unadjusted incidence rate ratios compared risk in HIV-uninfected persons to HIV-infected persons.||223.5|123.4|<0.001
72580236|NCT01339403|144689932|SUPERIORITY_OR_OTHER||Rate ratio|1.4|||<|0.001|TWO_SIDED|95.0|1.3|1.5|||Poisson Regression|||Poisson regression models were used to analyze rates of clinical events by HIV and unadjusted incidence rate ratios compared risk in HIV-uninfected persons to HIV-infected persons.||1.5|1.3|<0.001
72580237|NCT01339403|144689933|SUPERIORITY_OR_OTHER||Rate ratio|65.7|||<|0.001|TWO_SIDED|95.0|57.1|75.7|||Poisson Regression|||Wasting syndrome: Poisson regression models were used to analyze rates of clinical events by HIV and unadjusted incidence rate ratios compared risk in HIV-uninfected persons to HIV-infected persons.||75.7|57.1|<0.001
72580238|NCT01339403|144689933|SUPERIORITY_OR_OTHER||Rate ratio|428.5|||<|0.001|TWO_SIDED|95.0|292.2|628.5|||Poisson Regression|||Pneumocystis jirovecii pneumonia: Poisson regression models were used to analyze rates of clinical events by HIV and unadjusted incidence rate ratios compared risk in HIV-uninfected persons to HIV-infected persons.||628.5|292.2|<0.001
72580239|NCT01339403|144689933|SUPERIORITY_OR_OTHER||Rate ratio|8.7|||<|0.001|TWO_SIDED|95.0|7.9|9.5|||Poisson Regression|||Pneumonia, recurrent: Poisson regression models were used to analyze rates of clinical events by HIV and unadjusted incidence rate ratios compared risk in HIV-uninfected persons to HIV-infected persons.||9.5|7.9|<0.001
72580240|NCT01339403|144689933|SUPERIORITY_OR_OTHER||Rate ratio|97.1|||<|0.001|TWO_SIDED|95.0|75.5|124.8|||Poisson Regression|||Cytomegalovirus: Poisson regression models were used to analyze rates of clinical events by HIV and unadjusted incidence rate ratios compared risk in HIV-uninfected persons to HIV-infected persons.||124.8|75.5|<0.001
72580241|NCT01339403|144689933|SUPERIORITY_OR_OTHER||Rate ratio|60.2|||<|0.001|TWO_SIDED|95.0|48.3|74.9|||Poisson Regression|||Esophageal Candidiasis: Poisson regression models were used to analyze rates of clinical events by HIV and unadjusted incidence rate ratios compared risk in HIV-uninfected persons to HIV-infected persons.||74.9|48.3|<0.001
72580242|NCT01339403|144689933|SUPERIORITY_OR_OTHER||Rate ratio|98.4|||<|0.001|TWO_SIDED|95.0|70.8|136.8|||Poisson Regression|||Mycobacterium avium complex: Poisson regression models were used to analyze rates of clinical events by HIV and unadjusted incidence rate ratios compared risk in HIV-uninfected persons to HIV-infected persons.||136.8|70.8|<0.001
72580243|NCT01339403|144689933|SUPERIORITY_OR_OTHER||Rate ratio|189.5|||<|0.001|TWO_SIDED|95.0|112.3|319.5|||Poisson Regression|||Cryptococcosis: Poisson regression models were used to analyze rates of clinical events by HIV and unadjusted incidence rate ratios compared risk in HIV-uninfected persons to HIV-infected persons.||319.5|112.3|<0.001
72580244|NCT01339403|144689933|SUPERIORITY_OR_OTHER||Rate ratio|6.2|||<|0.001|TWO_SIDED|95.0|5.2|7.4|||Poisson Regression|||Mycobacterium tuberculosis: Poisson regression models were used to analyze rates of clinical events by HIV and unadjusted incidence rate ratios compared risk in HIV-uninfected persons to HIV-infected persons.||7.4|5.2|<0.001
72411775|NCT00406029|144331708|SUPERIORITY_OR_OTHER||Difference in LS Means|0.1||||0.742|TWO_SIDED|95.0|-0.5|0.6|||ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.6|-0.5|0.742
72411776|NCT00406029|144331708|SUPERIORITY_OR_OTHER||Difference in LS Means|0.3||||0.211|TWO_SIDED|95.0|-0.2|0.9|||ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.9|-0.2|0.211
72545694|NCT00294723|144620761|NON_INFERIORITY_OR_EQUIVALENCE|A test for superiority of liraglutide 1.8 mg to liraglutide 1.2 mg was performed to compare the two doses. Superiority of liraglutide 1.8 mg was concluded if the upper limit of the 2-sided 95% CI for the treatment difference (liraglutide 1.8 mg - liraglutide 1.2 mg) was below 0%.|Estimated treatment difference, LS Mean|-0.28||||0.0123||95.0|-0.49|-0.06||2-sided significance level 5%|ANCOVA|||Change in glycosylated haemoglobin (HbA1c) from baseline to end of treatment at 156 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country, and previous oral antidiabetic drug (OAD) treatment as fixed effects and baseline HbA1c as covariate.||-0.06|-0.49|0.0123
72545695|NCT00294723|144620762|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg and glimepiride was calculated. If the upper limit of the 95% CI was below 0 mg/dL, it was concluded that the given dose of liraglutide was better than glimepiride.|Estimated treatment difference, LS Mean|-4.0||||0.1396||95.0|-9.4|1.3||2-sided significance level 5%|ANCOVA|||Change in mean prandial increments of plasma glucose from baseline to end of treatment at 52 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.||1.3|-9.4|0.1396
72545696|NCT00294723|144620762|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.2 mg and glimepiride was calculated. If the upper limit of the 95% CI was below 0 mg/dL, it was concluded that the given dose of liraglutide was better than glimepiride.|Estimated treatment difference, LS Mean|-2.9||||0.2968||95.0|-8.3|2.5||2-sided significance level 5%|ANCOVA|||Change in mean prandial increments of plasma glucose from baseline to end of treatment at 52 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.||2.5|-8.3|0.2968
72545697|NCT00294723|144620762|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg and liraglutide 1.2 mg was calculated. If the upper limit of the 95% CI was below 0 mg/dL, it was concluded that liraglutide 1.8 mg was better than liraglutide 1.2 mg.|Estimated treatment difference, LS Mean|-1.2||||0.6639||95.0|-6.5|4.1||2-sided significance level 5%|ANCOVA|||Change in postprandial (PPG) from baseline to end of treatment at 52 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.||4.1|-6.5|0.6639
72545698|NCT00294723|144620763|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg and glimepiride was calculated. If the upper limit of the 95% CI was below 0 mg/dL, it was concluded that the given dose of liraglutide was better than glimepiride.|Estimated treatment difference, LS Mean|-3.81||||0.172||95.0|-9.28|1.66||2-sided significance level 5%|ANCOVA|||Change in prandial increments of plasma glucose from baseline to end of treatment at 104 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.||1.66|-9.28|0.1720
72545699|NCT00294723|144620763|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.2 mg and glimepiride was calculated. If the upper limit of the 95% CI was below 0 mg/dL, it was concluded that the given dose of liraglutide was better than glimepiride.|Estimated treatment difference, LS Mean|-0.33||||0.906||95.0|-5.82|5.16||2-sided significance level 5%|ANCOVA|||Change in prandial increments of plasma glucose from baseline to end of treatment at 104 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.||5.16|-5.82|0.9060
72545700|NCT00294723|144620763|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg and liraglutide 1.2 mg was calculated. If the upper limit of the 95% CI was below 0 mg/dL, it was concluded that liraglutide 1.8 mg was better than liraglutide 1.2 mg.|Estimated treatment difference, LS Mean|-3.48||||0.2089||95.0|-8.91|1.95||2-sided significance level 5%|ANCOVA|||Change in prandial increments of plasma glucose from baseline to end of treatment at 104 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.||1.95|-8.91|0.2089
72545701|NCT00294723|144620764|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg and glimepiride was calculated. If the upper limit of the 95% CI was below 0 mg/dL, it was concluded that the given dose of liraglutide was better than glimepiride.|Estimated treatment difference, LS Mean|-3.04||||0.2749||95.0|-8.51|2.42||2-sided significance level 5%|ANCOVA|||Change in prandial increments of plasma glucose from baseline to end of treatment at 156 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.||2.42|-8.51|0.2749
72545702|NCT00294723|144620764|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.2 mg and glimepiride was calculated. If the upper limit of the 95% CI was below 0 mg/dL, it was concluded that the given dose of liraglutide was better than glimepiride.|Estimated treatment difference, LS Mean|0.43||||0.8765||95.0|-5.05|5.92||2-sided significance level 5%|ANCOVA|||Change in prandial increments of plasma glucose from baseline to end of treatment at 156 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.||5.92|-5.05|0.8765
72580245|NCT01339403|144689933|SUPERIORITY_OR_OTHER||Rate ratio|594.5|||<|0.001|TWO_SIDED|95.0|146.5|2411.7|||Poisson Regression|||Progressive multifocal leukoencephalopathy: Poisson regression models were used to analyze rates of clinical events by HIV and unadjusted incidence rate ratios compared risk in HIV-uninfected persons to HIV-infected persons.||2411.7|146.5|<0.001
72580246|NCT01339403|144689933|SUPERIORITY_OR_OTHER||Rate ratio|10.6|||<|0.001|TWO_SIDED|95.0|7.8|14.4|||Poisson Regression|||Lung Candidiasis: Poisson regression models were used to analyze rates of clinical events by HIV and unadjusted incidence rate ratios compared risk in HIV-uninfected persons to HIV-infected persons.||14.4|7.8|<0.001
72545703|NCT00294723|144620764|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg and liraglutide 1.2 mg was calculated. If the upper limit of the 95% CI was below 0 mg/dL, it was concluded that liraglutide 1.8 mg was better than liraglutide 1.2 mg.|Estimated treatment difference, LS Mean|-3.48||||0.2088||95.0|-8.9|1.95||2-sided significance level 5%|ANCOVA|||Change in prandial increments of plasma glucose from baseline to end of treatment at 156 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.||1.95|-8.90|0.2088
72545704|NCT00752791|144620767|SUPERIORITY_OR_OTHER||Mean change from Baseline|0.1|||||TWO_SIDED|95.0|-0.24|0.44|||||A two-sided 95% CI of the estimated mean change from Baseline in hemoglobin was derived from the t-distribution.|||0.44|-0.24|
72545705|NCT01992107|144620774|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the upper bound of the two-sided 95% confidence interval (CI) for the ratio of GMTs (GMT TIV1c/GMT QIVc) for HI antibody does not exceed the non-inferiority margin of 1.5|Ratios of GMT (Day 22/Day 50)|1.03|||||TWO_SIDED|95.0|0.93|1.14|||ANCOVA|||Non-inferiority of immune responses of QIVc to TIV1c, assessed in terms of ratios of GMT against influenza strain A/H1N1||1.14|0.93|
72545706|NCT01992107|144620774|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the upper bound of the two-sided 95% confidence interval (CI) for the ratio of GMTs (GMT TIV1c/GMT QIVc) for HI antibody does not exceed the non-inferiority margin of 1.5|Ratios of GMT (Day 22/Day 50)|1.05|||||TWO_SIDED|95.0|0.97|1.14|||ANCOVA|||Non-inferiority of immune responses of QIVc to TIV1c, assessed in terms of ratios of GMT against influenza strain A/H3N2||1.14|0.97|
72545707|NCT01992107|144620774|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the upper bound of the two-sided 95% confidence interval (CI) for the ratio of GMTs (GMT TIV1c/GMT QIVc) for HI antibody does not exceed the non-inferiority margin of 1.5|Ratios of GMT (Day 22/Day 50)|0.99|||||TWO_SIDED|95.0|0.89|1.1|||ANCOVA|||Non-inferiority of immune responses of QIVc to TIV1c, assessed in terms of ratios of GMT against influenza strain B1||1.1|0.89|
72545708|NCT01992107|144620774|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the upper bound of the two-sided 95% confidence interval (CI) for the ratio of GMTs (GMT TIV2c/GMT QIVc) for HI antibody does not exceed the non-inferiority margin of 1.5|Ratios of GMT (Day 22/Day 50)|1.0|||||TWO_SIDED|95.0|0.87|1.14|||ANCOVA|||Non-inferiority of immune responses of QIVc to TIV2c, assessed in terms of ratios of GMT against influenza strain B2||1.14|0.87|
72545709|NCT01992107|144620775|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the upper bound of the two-sided 95% CI for the difference between seroconversion rates (% seroconversion TIV1c - % seroconversion QIVc) for HI antibody does not exceed the margin of 10%|Difference b/w SC rates (Day 22/Day 50)|2.0|||||TWO_SIDED|95.0|-2.5|6.9|||ANCOVA|||Non-inferiority of immune responses of QIVc to TIV1c in terms of differences in seroconversion rates against influenza strain A/H1N1||6.9|-2.5|
72545710|NCT01992107|144620775|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the upper bound of the two-sided 95% CI for the difference between seroconversion rates (% seroconversion TIV1c - % seroconversion QIVc) for HI antibody does not exceed the margin of 10%|Difference b/w SC rates (Day 22/Day 50)|4.0|||||TWO_SIDED|95.0|-1.4|9.2|||ANCOVA|||Non-inferiority of immune responses of QIVc to TIV1c in terms of differences in seroconversion rates against influenza strain A/H3N2||9.2|-1.4|
72411777|NCT00406029|144331708|SUPERIORITY_OR_OTHER||Difference in LS Means|0.0||||0.906|TWO_SIDED|95.0|-0.6|0.5|||ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.5|-0.6|0.906
72580247|NCT01339403|144689933|SUPERIORITY_OR_OTHER||Rate ratio|51.5|||<|0.001|TWO_SIDED|95.0|30.3|87.5|||Poisson Regression|||Toxoplasmosis of brain: Poisson regression models were used to analyze rates of clinical events by HIV and unadjusted incidence rate ratios compared risk in HIV-uninfected persons to HIV-infected persons.||87.5|30.3|<0.001
72545711|NCT01992107|144620775|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the upper bound of the two-sided 95% CI for the difference between seroconversion rates (% seroconversion TIV1c - % seroconversion QIVc) for HI antibody does not exceed the margin of 10%|Difference b/w SC rates (Day 22/Day 50)|0.0|||||TWO_SIDED|95.0|-5.5|4.5|||ANCOVA|||Non-inferiority of immune responses of QIVc to TIV1c in terms of differences in seroconversion rates against influenza strain B1||4.5|-5.5|
72545712|NCT01992107|144620775|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the upper bound of the two-sided 95% CI for the difference between seroconversion rates (% seroconversion TIV2c - % seroconversion QIVc) for HI antibody does not exceed the margin of 10%|Difference b/w SC rates (Day 22/Day 50)|-2.0|||||TWO_SIDED|95.0|-6.5|3.2|||ANCOVA|||Non-inferiority of immune responses of QIVc to TIV2c in terms of differences in seroconversion rates against influenza strain B2||3.2|-6.5|
72545713|NCT01992107|144620781|SUPERIORITY_OR_OTHER||Ratios of GMT (Day 22/Day 50)|0.25|||||TWO_SIDED|95.0|0.22|0.29||||||Superiority of immune responses of QIVc to TIV1c in terms of ratios of GMT against influenza strain B2.The upper bound of the two-sided 95% CI for the ratio of GMTs (GMT TIV1c/GMTQIVc) for HI antibody should not exceed the superiority margin of 1 met.||0.29|0.22|
72580248|NCT01339403|144689933|SUPERIORITY_OR_OTHER||Rate ratio|6.2|||<|0.001|TWO_SIDED|95.0|3.0|12.9|||Poisson Regression|||Coccidiomycosis: Poisson regression models were used to analyze rates of clinical events by HIV and unadjusted incidence rate ratios compared risk in HIV-uninfected persons to HIV-infected persons.||12.9|3.0|<0.001
72580249|NCT01339403|144689933|SUPERIORITY_OR_OTHER||Rate ratio|13.0|||<|0.0001|TWO_SIDED|95.0|7.4|23.1|||Poisson Regression|||Histoplasmosis: Poisson regression models were used to analyze rates of clinical events by HIV and unadjusted incidence rate ratios compared risk in HIV-uninfected persons to HIV-infected persons.||23.1|7.4|<0.0001
72580250|NCT01339403|144689934|SUPERIORITY_OR_OTHER||Rate ratio|4.7|||<|0.001|TWO_SIDED|95.0|4.3|5.1|||Poisson Regression|||Poisson regression models were used to analyze rates of clinical events by HIV and unadjusted incidence rate ratios compared risk in HIV-uninfected persons to HIV-infected persons.||5.1|4.3|<0.001
72580251|NCT01339403|144689935|SUPERIORITY_OR_OTHER||Rate ratio|7.0|||<|0.001|TWO_SIDED|95.0|6.0|8.2|||Poisson Regression|||Poisson regression models were used to analyze rates of clinical events by HIV and unadjusted incidence rate ratios compared risk in HIV-uninfected persons to HIV-infected persons.||8.2|6.0|<0.001
72580252|NCT01339403|144689936|SUPERIORITY_OR_OTHER||Rate ratio|8.3|||<|0.001|TWO_SIDED|95.0|7.1|9.6|||Poisson Regression|||Poisson regression models were used to analyze rates of clinical events by HIV and unadjusted incidence rate ratios compared risk in HIV-uninfected persons to HIV-infected persons.||9.6|7.1|<0.001
72580253|NCT01339403|144689937|SUPERIORITY_OR_OTHER||Rate ratio|5.6|||<|0.001|TWO_SIDED|95.0|5.3|5.9|||Poisson Regression|||Poisson regression models were used to analyze rates of clinical events by HIV and unadjusted incidence rate ratios compared risk in HIV-uninfected persons to HIV-infected persons.||5.9|5.3|<0.001
72580254|NCT01339403|144689938|SUPERIORITY_OR_OTHER||Rate ratio|19.8|||<|0.001|TWO_SIDED|95.0|11.2|35.2|||Poisson Regression|||Poisson regression models were used to analyze rates of clinical events by HIV and unadjusted incidence rate ratios compared risk in HIV-uninfected persons to HIV-infected persons.||35.2|11.2|<0.001
72580255|NCT03983980|144689939|SUPERIORITY||Risk Ratio (RR)|6.1|||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.0001
72580256|NCT03983980|144689940|SUPERIORITY||Risk Ratio (RR)|6.53|||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.0001
72580257|NCT03983980|144689941|SUPERIORITY||Risk Ratio (RR)|4.55|||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.0001
72580258|NCT03983980|144689942|SUPERIORITY||Least squares mean difference|-4.32|||<|0.0001|TWO_SIDED||||||ANCOVA|||||||<0.0001
72580259|NCT03983980|144689943|SUPERIORITY||Risk Ratio (RR)|7.25|||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.0001
72329530|NCT03517371|144184513|SUPERIORITY||Median Difference (Final Values)|2.17||||0.85|TWO_SIDED|95.0|-20.64|24.97|||t-test, 2 sided|Levene's test significant, equal variances not assumed values reported.||||24.97|-20.64|.85
72580260|NCT01349192|144689965|SUPERIORITY||Proportion Difference (Final Values)|0.56||||0.0005|TWO_SIDED|95.0|0.25|0.74||The a priori threshold for statistical significance was 0.05.|Chi-squared||Proportion difference was calculated as proportion negative for MRSA in the treatment group minus the proportion negative for MRSA in the observation group. 95% CI calculated using the Newcombe-Wilson method without continuity correction.|||0.74|0.25|0.0005
72580261|NCT01349192|144689965|SUPERIORITY||Proportion Difference (Final Values)|0.525||||0.0004|TWO_SIDED|95.0|0.23|0.8||Test includes adjustment for two interim reviews of efficacy data. The a priori threshold for statistical significance was 0.05.|Chi-squared||Proportion difference was calculated as proportion negative for MRSA in the treatment group minus the proportion negative for MRSA in the observation group.|||0.80|0.23|0.0004
72580262|NCT01349192|144689966|SUPERIORITY||Proportion Difference (Final Values)|0.09||||0.5463|TWO_SIDED|95.0|-0.18|0.34||The a priori threshold for statistical significance was 0.05.|Chi-squared||Proportion difference was calculated as proportion using antibiotics in the treatment group minus the proportion using antibiotics in the observation group. 95% CI calculated using the Newcombe-Wilson method without continuity correction.|||0.34|-0.18|0.5463
72580263|NCT01349192|144689967|SUPERIORITY||Mean Difference (Final Values)|-9.42||||0.3683|TWO_SIDED|95.0|-30.3|11.47||The a priori threshold for statistical significance was 0.05.|t-test, 2 sided||Mean difference was calculated as mean days of antibiotic use in the treatment group minus the mean days of antibiotic use in the observation group.|||11.47|-30.3|0.3683
72580264|NCT01349192|144689968|SUPERIORITY||Proportion Difference (Final Values)|-0.2||||0.1205|TWO_SIDED|95.0|-0.42|0.03||The a priori threshold for statistical significance was 0.05.|Chi-squared||Difference was calculated as proportion with a PE treated with MRSA active antibiotics in the treatment group minus the analogous proportion in the observation group. 95% CI calculated using the Newcombe-Wilson method without continuity correction.|||0.03|-0.42|0.1205
72580265|NCT01269918|144689996|NON_INFERIORITY_OR_EQUIVALENCE|We used a noninferiority delta of 7.5 mmHg. If noninferiority was detected, we proceeded to test for superiority.|Mean Difference (Final Values)|-9.0|||<|0.001|TWO_SIDED|95.0|-13.0|-5.0|||t-test, 1 sided|||Dexmedetomidine versus remifentanyl on MAP collapsed over time was estimated using a 1-tailed t test from a repeated measures ANOVA model.||-5|-13|< 0.001
72580266|NCT01269918|144689996|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.0|||<|0.001|TWO_SIDED|97.5|-13.0|-4.0|||t-test, 1 sided|||Dexmedetomidine versus remifentanyl on MAP collapsed over time was estimated using a 1-tailed t test from a repeated measures ANOVA model.||-4|-13|< 0.001
72580267|NCT01269918|144689997|NON_INFERIORITY_OR_EQUIVALENCE|We used a noninferiority delta of 1 point. If noninferiority was detected, we proceeded to test for superiority.|Mean Difference (Final Values)|-1.9|||<|0.001|TWO_SIDED|95.0|-2.7|-1.1|||t-test, 1 sided|||Dexmedetomidine versus remifentanyl on VAS pain score estimated from a 1-tailed t test from a repeated measures ANOVA model.||-1.1|-2.7|< 0.001
72411778|NCT00406029|144331708|SUPERIORITY_OR_OTHER||Difference in LS Means|0.0||||0.868|TWO_SIDED|95.0|-0.5|0.6|||ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.6|-0.5|0.868
72580268|NCT01269918|144689997|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.9|||<|0.001|TWO_SIDED|97.5|-2.8|-0.9|||t-test, 1 sided|||Dexmedetomidine versus remifentanyl on VAS pain score estimated from a 1-tailed t test from a repeated measures ANOVA model.||-0.9|-2.8|< 0.001
72580269|NCT01269918|144689998|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority delta = 2 mg opioid|Median Difference (Final Values)|-5.0|||<|0.001|TWO_SIDED|95.0|-10.0|-5.0|||Wilcoxon (Mann-Whitney)|||Dexmedetomidine versus remifentanyl on opioid consumption estimated from a Wilcoxon rank sum test||-5|-10|< 0.001
72580270|NCT01269918|144689998|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-5.0|||<|0.001|TWO_SIDED|97.5|-10.0|-3.0|||Wilcoxon (Mann-Whitney)|||Dexmedetomidine versus remifentanyl on opioid consumption estimated from a Wilcoxon rank sum test||-3|-10|< 0.001
72580271|NCT01269918|144689999|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.0|||<|0.001|TWO_SIDED|95.0|-10.0|3.0|||Mixed Models Analysis|||Dexmedetomidine versus remifentanyl on heart rate was assessed using a linear mixed effects model adjusting for baseline heart rate.||3|-10|< 0.001
72411779|NCT00406029|144331715|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.1||||0.747|TWO_SIDED|95.0|-0.6|0.4|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.4|-0.6|0.747
72545714|NCT01992107|144620782|SUPERIORITY_OR_OTHER||Difference b/w SC rates(Day 22/Day 50)|-47.0|||||TWO_SIDED|95.0|-51.1|-42.1||||||Superiority of immune responses of QIVc to TIV1c in terms of seroconversion rates against influenza strain B2.The upper bound of the 2-sided 95% CI for the difference between seroconversion rates (% seroconversion TIV1c - %seroconversion QIVc) for HI antibody should not exceed the margin of 0 points met.||-42.1|-51.1|
72545715|NCT01992107|144620783|SUPERIORITY_OR_OTHER||Ratios of GMT (Day 22/Day 50)|0.38|||||TWO_SIDED|95.0|0.35|0.42||||||Superiority of immune responses of QIVc to TIV2c in terms of ratios of GMT against influenza strain B1.The upper bound of the 2-sided 95% CI for the ratio of GMTs (GMT TIV2c /GMTQIVc) for HI antibody should not exceed the superiority margin of 1 met.||0.42|0.35|
72545716|NCT01992107|144620784|SUPERIORITY_OR_OTHER||Difference b/w SC rates(Day 22/Day 50)|-34.0|||||TWO_SIDED|95.0|-38.8|-29.3||||||Superiority of immune responses of QIVc to TIV2c in terms of seroconversion rates against influenza strain B1.The upper bound of the 2-sided 95% CI for the difference between seroconversion rates (% seroconversion TIV1c or TIV2c - %seroconversion QIVc) for HI antibody should not exceed the margin of 0 points met.||-29.3|-38.8|
72545717|NCT02444533|144620867|SUPERIORITY|||||||0.043|||||||t-test, 2 sided|||Comparison between groups for pain on day of surgery. Statistical significance was defined as a p-value less than 0.05.||||0.043
72545718|NCT02444533|144620867|SUPERIORITY|||||||0.445|||||||t-test, 2 sided|||Comparison between groups for pain at 14 days after surgery. Statistical significance was defined as a p-value less than 0.05.||||0.445
72545719|NCT02444533|144620868|SUPERIORITY|||||||0.65|||||||t-test, 2 sided|||Comparison between groups for ibuprofen usage. Statistical significance was defined as a p-value less than 0.05.||||0.650
72545720|NCT02444533|144620868|SUPERIORITY|||||||0.97|||||||t-test, 2 sided|||Comparison between groups for acetaminophen usage. Statistical significance was defined as a p-value less than 0.05.||||0.970
72545721|NCT02444533|144620868|SUPERIORITY|||||||0.835|||||||t-test, 2 sided|||Comparison between groups for oxycodone usage. Statistical significance was defined as a p-value less than 0.05.||||0.835
72545722|NCT02444533|144620869|SUPERIORITY|||||||1|||||||t-test, 2 sided|||Comparison between groups at 7 days. Statistical significance was defined as a p-value less than 0.05.||||1.0
72580272|NCT01269918|144690000|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.1||||0.16|TWO_SIDED|95.0|-2.6|0.5|||Mixed Models Analysis|||Dexmedetomidine versus remifentanyl on SOMCT estimated using a linear mixed effects model adjusting for baseline SOMCT score.||0.5|-2.6|0.16
72580273|NCT01269918|144690001|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3||||0.07|TWO_SIDED|95.0|-0.6|0.03|||Mixed Models Analysis|||Dexmedetomidine versus remifentanyl on Aldrete score estimated using a linear mixed effects model adjusting for baseline Aldrete score.||0.03|-0.6|0.07
72580274|NCT01269918|144690002|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-1.0||||0.009|TWO_SIDED|95.0|-1.0|-0.001|||Wilcoxon (Mann-Whitney)|||Dexmedetomidine versus remifentanyl on Nursing workload comparison estimated using a Wilcoxon rank sum test.||-0.001|-1|0.009
72545723|NCT00952484|144620958|SUPERIORITY_OR_OTHER|||||||0.0007|TWO_SIDED|||||P-value based on Wilcoxon rank sum test comparing the median RGI-C score for the asfotase alfa combined reporting group to the historical control group.|Wilcoxon (Mann-Whitney)|||||||0.0007
72545724|NCT00952484|144620959|SUPERIORITY_OR_OTHER|||||||0.0097|TWO_SIDED|||||P-value testing whether the mean change from Baseline differs from Zero based on a t-test.|t-test, 2 sided|||||||0.0097
72411780|NCT00406029|144331715|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.4||||0.14|TWO_SIDED|95.0|-0.9|0.1|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.1|-0.9|0.140
72411781|NCT00406029|144331715|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.4||||0.148|TWO_SIDED|95.0|-0.9|0.1|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.1|-0.9|0.148
72411782|NCT00406029|144331715|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.7||||0.005|TWO_SIDED|95.0|-1.2|-0.2|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.||-0.2|-1.2|0.005
72411783|NCT00406029|144331715|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.3||||0.256|TWO_SIDED|94.0|-0.8|0.2|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.2|-0.8|0.256
72411784|NCT00406029|144331715|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.3||||0.343|TWO_SIDED|95.0|-0.8|0.3|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.3|-0.8|0.343
72411785|NCT00406029|144331715|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.4||||0.102|TWO_SIDED|95.0|-1.0|0.1|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.1|-1.0|0.102
72411786|NCT00406029|144331715|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.4||||0.161|TWO_SIDED|95.0|-0.9|0.2|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.2|-0.9|0.161
72411787|NCT00406029|144331715|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.4||||0.15|TWO_SIDED|95.0|-0.9|0.1|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.1|-0.9|0.150
72411788|NCT00406029|144331715|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.3||||0.175|TWO_SIDED|95.0|-0.9|0.2|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.2|-0.9|0.175
72411789|NCT00406029|144331715|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.7||||0.013|TWO_SIDED|95.0|-1.2|-0.1|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.||-0.1|-1.2|0.013
72545725|NCT00952484|144620960|SUPERIORITY_OR_OTHER|||||||0.0789|TWO_SIDED|||||P-value testing whether the mean change from Baseline differs from Zero based on a t-test.|t-test, 2 sided|||||||0.0789
72545726|NCT00952484|144620961|SUPERIORITY_OR_OTHER|||||||0.7417|TWO_SIDED|||||P-value testing whether the mean change from Baseline differs from Zero based on a t-test.|t-test, 2 sided|||||||0.7417
72545727|NCT00952484|144620962|SUPERIORITY_OR_OTHER|||||||0.757|TWO_SIDED|||||P-value testing whether the mean change from Baseline differs from Zero based on a Wilcoxon Signed-Rank test.|Wilcoxon Signed-Rank|||||||0.7570
72545728|NCT00952484|144620963|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-value testing whether the mean change from Baseline differs from Zero based on a t-test.|t-test, 2 sided|||||||<0.0001
72545729|NCT00952484|144620964|SUPERIORITY_OR_OTHER|||||||0.0007|TWO_SIDED|||||P-value testing whether the mean change from Baseline differs from Zero based on a t-test.|t-test, 2 sided|||||||0.0007
72545730|NCT05085613|144620971|SUPERIORITY||Mean Difference (Final Values)|0.6279928|STANDARD_ERROR_OF_MEAN|4.150369||0.998|TWO_SIDED|95.0|-9.463627|10.71961||Sidak's adjusted p-value for multiple comparisons|ANCOVA|DF=6|Economic recovery condition - control|Note that analyses are underpowered due to administrative issues with funding that halted recruitment early.||10.71961|-9.463627|0.998
72545731|NCT05085613|144620971|SUPERIORITY||Mean Difference (Final Values)|4.044194|STANDARD_ERROR_OF_MEAN|4.302202||0.725|TWO_SIDED|95.0|-6.416608|14.505||Sidak's adjusted p-value for multiple comparisons|ANCOVA|DF = 6|Freedom - control|Note that analyses are underpowered due to administrative issues with funding that halted recruitment early.||14.505|-6.416608|0.725
72545732|NCT05085613|144620971|SUPERIORITY||Mean Difference (Final Values)|-1.53656|STANDARD_ERROR_OF_MEAN|-1.53656||0.98|TWO_SIDED|95.0|-12.25295|9.179834||Sidak's adjusted p-value for multiple comparisons|ANCOVA|DF = 6|Humor - control|Note that analyses are underpowered due to administrative issues with funding that halted recruitment early.||9.179834|-12.25295|0.980
72545733|NCT05085613|144620972|SUPERIORITY||Mean Difference (Final Values)|7.002255|STANDARD_ERROR_OF_MEAN|8.801527||0.813|TWO_SIDED|95.0|-14.39448|28.39899||Sidak's adjusted p-value for multiple comparisons|ANCOVA|Df = 6|Economic recovery condition - control|Note that analyses are underpowered due to administrative issues with funding that halted recruitment early.||28.39899|-14.39448|0.813
72580275|NCT01269918|144690003|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.11|||<|0.001|TWO_SIDED|95.0|0.07|0.18|||Regression, Cox|||Remifentanyl versus Dexmedetomidine on time to open eyes estimated using Cox regression.||0.18|0.07|< 0.001
72580276|NCT01269918|144690004|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.12|||<|0.001|TWO_SIDED|95.0|0.07|0.19|||Regression, Cox|||Remifentanyl versus dexmedetomidine on time to recall assessed using Cox regression.||0.19|0.07|< 0.001
72580277|NCT01269918|144690005|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.68||||0.022|TWO_SIDED|95.0|0.48|0.95|||Regression, Cox|||Remifentanyl versus Dexmedetomidine on time to fitness discharge estimated using Cox regression.||0.95|0.48|0.022
72580278|NCT01269918|144690006|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.1||||0.45|TWO_SIDED|95.0|0.81|1.62|||Regression, Cox|||Remifentanyl versus Dexmedetomidine on time to PACU discharge estimated using Cox proportional hazard regression||1.62|0.81|0.45
72580279|NCT01269918|144690007|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.0||||0.91|TWO_SIDED|95.0|0.5|2.2|||Chi-squared|||Dexmedetomidine versus remifentanyl on postoperative nausea estimated from chi squared test.||2.2|0.5|0.91
72411790|NCT00406029|144331715|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.4||||0.12|TWO_SIDED|95.0|-0.9|0.1|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.1|-0.9|0.120
72411791|NCT00406029|144331715|SUPERIORITY_OR_OTHER||Difference in LS Means|0.0||||0.971|TWO_SIDED|95.0|-0.6|0.6|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.6|-0.6|0.971
72545734|NCT05085613|144620972|SUPERIORITY||Mean Difference (Final Values)|15.12214|STANDARD_ERROR_OF_MEAN|9.07444||0.268|TWO_SIDED|95.0|-6.938055|37.18234||Sidak's adjusted p-value for multiple comparisons|ANCOVA|DF = 6|Freedom - control|Note that analyses are underpowered due to administrative issues with funding that halted recruitment early.||37.18234|-6.938055|0.268
72545735|NCT05085613|144620972|SUPERIORITY||Mean Difference (Final Values)|14.4032|STANDARD_ERROR_OF_MEAN|9.305576||0.33|TWO_SIDED|95.0|-8.218891|37.0253||Sidak's adjusted p-value for multiple comparisons|ANCOVA|DF = 6|Humor - Control|Note that analyses are underpowered due to administrative issues with funding that halted recruitment early.||37.0253|-8.218891|0.330
72545736|NCT05085613|144620973|SUPERIORITY||Mean Difference (Final Values)|-1.457003|STANDARD_ERROR_OF_MEAN|6.380984||0.994|TWO_SIDED|95.0|-16.98852|14.07451||Sidak's adjusted p-value for multiple comparisons|ANCOVA|DF = 5|Economic recovery - control|Note that analyses are underpowered due to administrative issues with funding that halted recruitment early.||14.07451|-16.98852|0.994
72545737|NCT05085613|144620973|SUPERIORITY||Mean Difference (Final Values)|-1.097586|STANDARD_ERROR_OF_MEAN|6.675066||0.998|TWO_SIDED|95.0|-17.34491|15.14973||Sidak's adjusted p-value for multiple comparisons|ANCOVA|DF = 5|Freedom - control|Note that analyses are underpowered due to administrative issues with funding that halted recruitment early.||15.14973|-17.34491|0.998
72545738|NCT05085613|144620973|SUPERIORITY||Mean Difference (Final Values)|8.926191|STANDARD_ERROR_OF_MEAN|6.588643||0.447|TWO_SIDED|95.0|-7.110771|24.96315||Sidak's adjusted p-value for multiple comparisons|ANCOVA|DF = 5|Humor - Control|Note that analyses are underpowered due to administrative issues with funding that halted recruitment early.||24.96315|-7.110771|0.447
72545739|NCT05085613|144620974|SUPERIORITY||Mean Difference (Final Values)|-4.154612|STANDARD_ERROR_OF_MEAN|1.986723||0.113|TWO_SIDED|95.0|-8.985328|0.6761041||Sidak's adjusted p-value for multiple comparisons|ANCOVA|DF = 6|Economic recovery - control|Note that analyses are underpowered due to administrative issues with funding that halted recruitment early.||.6761041|-8.985328|0.113
72545740|NCT05085613|144620974|SUPERIORITY||Mean Difference (Final Values)|-2.685896|STANDARD_ERROR_OF_MEAN|2.046067||0.473|TWO_SIDED|95.0|-7.6609|2.289114||Sidak's adjusted p-value for multiple comparisons|ANCOVA|DF = 6|Freedom - control|Note that analyses are underpowered due to administrative issues with funding that halted recruitment early.||2.289114|-7.66090|0.473
72545741|NCT05085613|144620974|SUPERIORITY||Mean Difference (Final Values)|-6.469932|STANDARD_ERROR_OF_MEAN|2.102231||0.008|TWO_SIDED|95.0|-11.58151|-1.358358||Sidak's adjusted p-value for multiple comparisons|ANCOVA|DF = 6|Humor - control|Note that analyses are underpowered due to administrative issues with funding that halted recruitment early.||-1.358358|-11.58151|0.008
72545742|NCT02422290|144620975|SUPERIORITY||Mean Difference (Final Values)|1.53|STANDARD_ERROR_OF_MEAN|1.83||0.2|TWO_SIDED|95.0|-2.27|7.87|||t-test, 2 sided|||Paired sample t-test was calculated to test mean difference between CY-BOCS scores at the time points Baseline and Day 14.||7.87|-2.27|.20
72545743|NCT02422290|144620976|SUPERIORITY||Mean Difference (Final Values)|1.63|STANDARD_ERROR_OF_MEAN|0.49||0.18|TWO_SIDED|95.0|-0.56|2.16|||t-test, 2 sided|||Paired sample t-test was calculated to test mean difference between CGI-S scores at the time points Baseline and Day 14.||2.16|-.56|.18
72545744|NCT02422290|144620977|SUPERIORITY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|1.0||1|TWO_SIDED|95.0|-2.78|2.78|||t-test, 2 sided|||Paired sample t-test was calculated to test mean difference between OCD-VAS scores at the time points Baseline and Day 14.||2.78|-2.78|1.00
72545745|NCT02422290|144620978|SUPERIORITY||Mean Difference (Final Values)|0.32|STANDARD_ERROR_OF_MEAN|5.41||0.77|TWO_SIDED|95.0|-15.46|18.96|||t-test, 2 sided|||Paired sample t-test was calculated to test mean difference between OCD-VAS scores at the time points Baseline and Day 14.||18.96|-15.46|.77
72545746|NCT01842958|144620991|NON_INFERIORITY|The test arm will be considered non-inferior to the control arm if the 95% upper confidence interval of the estimated difference between the test and control arms is less than -0.5mm.||||||0.02|||||||ANCOVA|||The primary efficacy endpoint is change in crestal bone level from loading to 12 months post-loading. The primary analysis is a test for non-inferiority of the test implant to the control implant at the one-sided 5% significance level. The null hypothesis is that µ3.3 ≥ µ4.1 + δ, where µ3.3 is the mean change in crestal bone level for the test implants, µ4.1 is the mean change in crestal bone level for control implants, and δ is a pre-specified clinically significant difference.||||0.02
72545747|NCT00818623|144621005|SUPERIORITY_OR_OTHER_LEGACY|||||||5.86e-05||95.0|||||Log Rank|||||||0.0000586
72545748|NCT00818623|144621006|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0014||95.0|||||Kruskal-Wallis|||||||0.0014
72545749|NCT00818623|144621006|SUPERIORITY_OR_OTHER_LEGACY||Percentage of participants castrated|87.5||||||95.0|66.1|95.8||||||Percentage of participants castrated (testosterone ≤0.5 ng/mL) for at least 28 days.||95.8|66.1|
72545750|NCT00818623|144621006|SUPERIORITY_OR_OTHER_LEGACY||Percentage of participants castrated|66.7||||||95.0|33.7|86.0||||||Percentage of participants castrated (testosterone ≤0.5 ng/mL) for at least 28 days.||86|33.7|
72545751|NCT00818623|144621006|SUPERIORITY_OR_OTHER_LEGACY||Percentage of participants castrated|54.5||||||95.0|22.9|78.0||||||Percentage of participants castrated (testosterone ≤0.5 ng/mL) for at least 28 days.||78|22.9|
72545752|NCT00818623|144621006|SUPERIORITY_OR_OTHER_LEGACY||Percentage of participants castrated|100.0||||||95.0|85.8|100.0||||||Percentage of participants castrated (testosterone ≤0.5 ng/mL) for at least 28 days.||100|85.8|
72545753|NCT00818623|144621006|SUPERIORITY_OR_OTHER_LEGACY||Percentage of participants castrated|75.0||||||95.0|52.6|87.9||||||Percentage of participants castrated (testosterone ≤0.5 ng/mL) for at least 28 days.||87.9|52.6|
72411792|NCT00406029|144331715|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.2||||0.456|TWO_SIDED|95.0|-0.7|0.3|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.3|-0.7|0.456
72411793|NCT00406029|144331715|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.7||||0.018|TWO_SIDED|95.0|-1.2|-0.1|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.||-0.1|-1.2|0.018
72411794|NCT00406029|144331715|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.4||||0.175|TWO_SIDED|95.0|-0.9|0.2|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.2|-0.9|0.175
72545754|NCT00818623|144621006|SUPERIORITY_OR_OTHER_LEGACY||Percentage of participants castrated|95.7||||||95.0|72.9|99.4||||||Percentage of participants castrated (testosterone ≤0.5 ng/mL) for at least 28 days.||99.4|72.9|
72545755|NCT00818623|144621006|SUPERIORITY_OR_OTHER_LEGACY||Percentage of participants castrated|62.5||||||95.0|40.3|78.4||||||Percentage of participants castrated (testosterone ≤0.5 ng/mL) for at least 28 days.||78.4|40.3|
72545756|NCT00818623|144621006|SUPERIORITY_OR_OTHER_LEGACY||Percentage of participants castrated|88.9||||||95.0|69.4|96.3||||||Percentage of participants castrated (testosterone ≤0.5 ng/mL) for at least 28 days.||96.3|69.4|
72545757|NCT00818623|144621007|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0031||95.0|||||Kruskal-Wallis|||||||0.0031
72580280|NCT01269918|144690008|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.4||||0.16|TWO_SIDED|95.0|0.07|1.7|||Chi-squared|||Dexmedetomidine versus remifentanyl on postoperative vomiting estimated from a chi square test.||1.7|0.07|0.16
72580281|NCT01269918|144690009|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.4||||0.21|TWO_SIDED|95.0|0.1|1.7|||Chi-squared|||Dexmedetomidine versus remifentanyl on incidence of shivering estimated from a chi square test.||1.7|0.1|0.21
72580282|NCT04471428|144690045|SUPERIORITY|Stratified Analysis: Stratification factors include histology, and prior NSCLC treatment regimens|Hazard Ratio (HR)|0.884||||0.3668|TWO_SIDED|95.0|0.676|1.156|||Log Rank||Hazard ratio was estimated by Cox regression model.|||1.156|0.676|0.3668
72580283|NCT04471428|144690045|SUPERIORITY||Hazard Ratio (HR)|0.907||||0.4709|TWO_SIDED|95.0|0.696|1.182|||Log Rank||Hazard ratio was estimated by Cox regression model.|Unstratified Analysis||1.182|0.696|0.4709
72580284|NCT04471428|144690046|SUPERIORITY||Hazard Ratio (HR)|0.735||||0.0079|TWO_SIDED|95.0|0.585|0.923|||Log Rank||Hazard ratio was estimated by Cox regression model.|Stratified Analysis; Stratification factors include histology, and prior NSCLC treatment regimens||0.923|0.585|0.0079
72580285|NCT04471428|144690046|SUPERIORITY||Hazard Ratio (HR)|0.731||||0.0061|TWO_SIDED|95.0|0.583|0.915|||Log Rank||Hazard ratio was estimated by Cox regression model.|Unstratified analysis||0.915|0.583|0.0061
72580286|NCT04471428|144690047|SUPERIORITY||Difference in Response Rates|-1.51||||0.6846|TWO_SIDED|95.0|-8.85|5.84|||Cochran-Mantel-Haenszel||95% CIs was computed using the Wald method.|Stratified analysis; stratification factors- histology, prior NSCLC treatment regimens||5.84|-8.85|0.6846
72580287|NCT04471428|144690047|SUPERIORITY||Odds Ratio (OR)|0.88|||||TWO_SIDED|95.0|0.47|1.63|||||Odds ratios were estimated by logistic regression. 95% CIs was computed using the Wald method.|Stratified analysis; stratification factors- histology, prior NSCLC treatment regimens||1.63|0.47|
72580288|NCT04471428|144690047|SUPERIORITY||Difference in Response Rates|-1.51||||0.7216|TWO_SIDED|95.0|-8.85|5.84|||Chi-squared, Corrected||95% CIs was computed using the Wald method.|Unstratified Analysis||5.84|-8.85|0.7216
72580289|NCT04471428|144690047|SUPERIORITY||Odds Ratio (OR)|0.87|||||TWO_SIDED|95.0|0.47|1.62|||||Odds ratios were estimated by logistic regression. 95% CIs was computed using the Wald method.|Unstratified Analysis||1.62|0.47|
72580290|NCT04471428|144690049|SUPERIORITY||Hazard Ratio (HR)|0.82||||0.27|TWO_SIDED|95.0|0.59|1.16|||Log Rank||Hazard ratio was estimated by Cox regression model.|Stratified Analysis: Stratification factors include histology, and prior NSCLC treatment regimens||1.16|0.59|0.2700
72580291|NCT04471428|144690049|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.3031|TWO_SIDED|95.0|0.6|1.17|||Log Rank||Hazard ratio was estimated by Cox regression model.|Unstratified Analysis||1.17|0.60|0.3031
72580292|NCT04471428|144690050|SUPERIORITY||Hazard Ratio (HR)|1.24||||0.2408|TWO_SIDED|95.0|0.86|1.79|||Log Rank||Hazard ratio was estimated by Cox regression model.|Stratification factors include histology, and prior NSCLC treatment regimens||1.79|0.86|0.2408
72580293|NCT04471428|144690050|SUPERIORITY||Hazard Ratio (HR)|1.26||||0.1992|TWO_SIDED|95.0|0.88|1.81|||Log Rank||Hazard ratio was estimated by Cox regression model.|Unstratified Analysis||1.81|0.88|0.1992
72580294|NCT04471428|144690051|SUPERIORITY||Difference in Event Free Rate|15.85||||0.0014|TWO_SIDED|95.0|6.12|25.59|||z-test||The 95% CI for the difference in PFS rates were estimated using the normal approximation method, with standard errors computed using the Greenwood method.|At 6 months||25.59|6.12|0.0014
72580295|NCT04471428|144690051|SUPERIORITY||Difference in Event Free Rate|6.32||||0.0719|TWO_SIDED|95.0|-0.56|13.21|||z-test||The 95% CI for the difference in PFS rates were estimated using the normal approximation method, with standard errors computed using the Greenwood method.|At 1 year||13.21|-0.56|0.0719
72580296|NCT04471428|144690052|SUPERIORITY||Difference in Event Free Rate|-0.85||||0.8767|TWO_SIDED|95.0|-11.63|9.92|||z-test||The 95% CI for the difference in OS rates were estimated using the normal approximation method, with standard errors computed using the Greenwood method.|At 1 year||9.92|-11.63|0.8767
72580297|NCT00129545|144690064|NON_INFERIORITY_OR_EQUIVALENCE|The posterior probability of non-inferiority is defined as the probability that the event rate for the Device group is less than twice that for the Control group. This probability was required to be greater than 0.975 for a finding of non-inferiority. The criterion for non-inferiority was consistently met at each analysis time point demonstrating the Device group is non-inferior to the Control group.|Risk Ratio (RR)|0.61|||||TWO_SIDED|95.0|0.42|1.07|||||Relative Risk calculated as Device Rate over Control rate, with 95% Credible Intervals|||1.07|0.42|
72545758|NCT00818623|144621007|SUPERIORITY_OR_OTHER_LEGACY||Percentage of participants castrated|45.8||||||95.0|25.6|64.0||||||Percentage of participants castrated (testosterone ≤0.5 ng/mL) for at least 84 days.||64|25.6|
72545759|NCT00818623|144621007|SUPERIORITY_OR_OTHER_LEGACY||Percentage of participants castrated|38.1||||||95.0|12.1|64.3||||||Percentage of participants castrated (testosterone ≤0.5 ng/mL) for at least 84 days.||64.3|12.1|
72545760|NCT00818623|144621007|SUPERIORITY_OR_OTHER_LEGACY||Percentage of participants castrated|32.7||||||95.0|8.3|60.6||||||Percentage of participants castrated (testosterone ≤0.5 ng/mL) for at least 84 days.||60.6|8.3|
72545761|NCT00818623|144621007|SUPERIORITY_OR_OTHER_LEGACY||Percentage of participants castrated|83.3||||||95.0|61.5|93.4||||||Percentage of participants castrated (testosterone ≤0.5 ng/mL) for at least 84 days.||93.4|61.5|
72545762|NCT00818623|144621007|SUPERIORITY_OR_OTHER_LEGACY||Percentage of participants castrated|49.4||||||95.0|28.3|67.4||||||Percentage of participants castrated (testosterone ≤0.5 ng/mL) for at least 84 days.||67.4|28.3|
72545763|NCT00818623|144621007|SUPERIORITY_OR_OTHER_LEGACY||Percentage of participants castrated|82.0||||||95.0|58.8|92.8||||||Percentage of participants castrated (testosterone ≤0.5 ng/mL) for at least 84 days.||92.8|58.8|
72545764|NCT00818623|144621007|SUPERIORITY_OR_OTHER_LEGACY||Percentage of participants castrated|50.0||||||95.0|29.1|67.8||||||Percentage of participants castrated (testosterone ≤0.5 ng/mL) for at least 84 days.||67.8|29.1|
72545765|NCT00818623|144621007|SUPERIORITY_OR_OTHER_LEGACY||Percentage of participants castrated|70.4||||||95.0|49.4|83.9||||||Percentage of participants castrated (testosterone ≤0.5 ng/mL) for at least 84 days.||83.9|49.4|
72545766|NCT00818623|144621008|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0866||95.0|||||Log Rank|||||||0.0866
72545767|NCT00818623|144621009|SUPERIORITY_OR_OTHER_LEGACY|||||||0.033||95.0|||||Log Rank|||||||0.033
72545768|NCT00818623|144621010|SUPERIORITY_OR_OTHER_LEGACY|||||||0.131||95.0|||||Log Rank|||||||0.131
72545769|NCT00602030|144621014|SUPERIORITY||Adjusted Odds Ratio|0.72||||0.505|TWO_SIDED|95.0|0.27|1.89|||Cochran-Mantel-Haenszel||Cochran-Mantel-Haenszel estimation of odds ratio adjusted for the smoking history stratification factor, using placebo as reference group.|||1.89|0.27|0.505
72545770|NCT00602030|144621015|SUPERIORITY||Adjusted Odds Ratio|0.31||||0.13|TWO_SIDED|95.0|0.06|1.54|||Cochran-Mantel-Haenszel||Estimation of odds ratio was adjusted for the smoking history stratification factor, using placebo as reference group .|||1.54|0.06|0.13
72545771|NCT00602030|144621016|SUPERIORITY||Adjusted Odds Ratio|1.06||||0.918|TWO_SIDED|95.0|0.34|3.27|||Cochran-Mantel-Haenszel||Estimation of odds ratio was adjusted for the smoking history stratification factor, using placebo as reference group.|||3.27|0.34|0.918
72545772|NCT02649231|144621049|SUPERIORITY||Odds Ratio (OR)|0.7|||||TWO_SIDED|95.0|0.28|1.75||||||Confirmed alcohol relapse by drug condition at 6 months using the Alcohol Timeline-Followback. Logistic regression modelling was used to compare the ketamine group with the placebo group (combined across therapy and alcohol education).||1.75|0.28|
72411795|NCT00406029|144331715|SUPERIORITY_OR_OTHER||Difference in LS Means|0.2||||0.422|TWO_SIDED|95.0|-0.3|0.8|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.8|-0.3|0.422
72411796|NCT00406029|144331715|SUPERIORITY_OR_OTHER||Difference in LS Means|0.1||||0.651|TWO_SIDED|95.0|-0.4|0.6|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.6|-0.4|0.651
72411797|NCT00406029|144331715|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.5||||0.096|TWO_SIDED|95.0|-1.0|0.1|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.1|-1.0|0.096
72411798|NCT00406029|144331715|SUPERIORITY_OR_OTHER||Difference in LS Means|0.0||||0.86|TWO_SIDED|95.0|-0.5|0.6|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.6|-0.5|0.860
72411799|NCT00406029|144331715|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.2||||0.511|TWO_SIDED|95.0|-0.8|0.4|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.4|-0.8|0.511
72411800|NCT00406029|144331715|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.3||||0.286|TWO_SIDED|95.0|-0.9|0.3|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.3|-0.9|0.286
72545773|NCT02649231|144621050|SUPERIORITY||Mean Difference (Final Values)|10.1|||||TWO_SIDED|95.0|1.1|19.0||||||Linear regression modelling was used to compare the ketamine group with the placebo group (combined across therapy and psychoeducation). Only participants with a minimum of 159 days of completed drinking self-report data were included in the main ITT analysis as this was the shortest duration of time before any participant completed the 6 month (23-25 week) follow up in the study. Reporting time was capped at 180 days.||19.0|1.1|
72545774|NCT00891878|144621058|SUPERIORITY|||||||0.43|||||||Log Rank|||||||0.43
72411801|NCT00406029|144331715|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.9||||0.004|TWO_SIDED|95.0|-1.4|-0.3|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.||-0.3|-1.4|0.004
72411802|NCT00406029|144331715|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.5||||0.06|TWO_SIDED|95.0|-1.1|0.0|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.0|-1.1|0.060
72580298|NCT01184079|144690079|NON_INFERIORITY_OR_EQUIVALENCE|"Sample size: (1 + 1/u)(Zα + Zβ)2 σ2 /\[log (RGMT) -δ0\] u= ratio of the size of the Standard schedule to Alternate schedule groups (u =1, for equal size groups); one-sided alpha (0.025)/4 for multiplicity of serotypes. Average log-transformed and geometric mean titers (GMTs) with a two-sided 95% confidence interval of the ratio of the GMTs were used.~Non-inferiority is determined if upper bound GMT ratio of standard group to alternate group \< 1.5."|largest upper bound GMT ratio|0.82|||||||||||||Non-inferiority is determined if upper bound GMT ratio of standard 6 month group to alternate 12 month group \< 1.5.|The primary endpoint would demonstrate noninferiority if the upper bound of the 95% two-sided confidence interval (CI) of the ratio of GMT for Standard schedule group divided by that of Alternate schedule group is \<1.5.||||
72580299|NCT01184079|144690081|SUPERIORITY_OR_OTHER|||||||0.26|TWO_SIDED||||||Chi-squared|||null hypothsesis: no difference in proportion of side effects reported between groups||||0.26
72580300|NCT00143390|144690085|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority of exemestane to anastrozole was to be concluded if the upper bound of the 95% confidence interval on the hazard ratio (exemestane/anastrozole) was ≤1.25.|Hazard Ratio (HR)|1.007|||||TWO_SIDED|95.0|0.771|1.317|||||Disease sites, use of postoperative adjuvant antiestrogen agents therapy, and pamidronate disodium were covariates for adjustment.|95% Confidence Interval based on the Brookmeyer and Crowley method||1.317|0.771|
72329531|NCT03517371|144184514|SUPERIORITY||Mean Difference (Final Values)|-0.008||||0.824|TWO_SIDED|95.0|-0.081|0.065|||t-test, 2 sided|||||.065|-.081|.824
72411803|NCT00406029|144331715|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.3||||0.345|TWO_SIDED|95.0|-0.8|0.3|||ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.3|-0.8|0.345
72411804|NCT00406029|144331715|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.2||||0.439|TWO_SIDED|95.0|-0.7|0.3|||ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.3|-0.7|0.439
72411805|NCT00406029|144331715|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.8||||0.004|TWO_SIDED|95.0|-1.4|0.3|||ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.3|-1.4|0.004
72411806|NCT00406029|144331715|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.6||||0.04|TWO_SIDED|95.0|-1.1|0.0|||ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.0|-1.1|0.040
72411807|NCT00406029|144331716|SUPERIORITY_OR_OTHER||Difference in LS Means|0.2||||0.743|TWO_SIDED|95.0|-1.1|1.6|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.6|-1.1|0.743
72411808|NCT00406029|144331716|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.8||||0.225|TWO_SIDED|95.0|-2.2|0.5|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.5|-2.2|0.225
72411809|NCT00406029|144331716|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.8||||0.252|TWO_SIDED|95.0|-2.2|0.6|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.6|-2.2|0.252
72545775|NCT00891878|144621059|SUPERIORITY|||||||0.45|||||||Fisher Exact|||||||0.45
72545776|NCT01199601|144621068|SUPERIORITY_OR_OTHER||Incidence Rate Ratio|1.12|STANDARD_DEVIATION|0.05|<|0.05|TWO_SIDED|95.0|1.02|1.23|||Regression, Linear|Information provided for crude analysis results; adjustment for significant baseline differences between groups did not change results substantially.||Outcomes were assessed by crude and adjusted risk ratios with log-binomial generalized linear models.||1.23|1.02|<0.05
72545777|NCT01199601|144621069|SUPERIORITY_OR_OTHER||Incidence Rate Ratio|1.1|STANDARD_DEVIATION|0.05|<|0.05|TWO_SIDED|95.0|1.02|1.18|||Regression, Linear|Outcomes were assessed by crude and adjusted risk ratios with log-binomial generalized linear models.||||1.18|1.02|<0.05
72545778|NCT01199601|144621070|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.13|STANDARD_DEVIATION|0.05||0.05|TWO_SIDED|95.0|1.01|1.25|||Regression, Logistic|The crude analysis result is provided as the odds ratio did not change substantially when adjusted for possible confounders.||||1.25|1.01|0.05
72545779|NCT01688037|144621101|OTHER||Mean Difference (Final Values)|-0.8|STANDARD_ERROR_OF_MEAN|0.8||0.2966|TWO_SIDED|95.0|-2.3|0.7|||ANCOVA|||||0.7|-2.3|0.2966
72545780|NCT01688037|144621102|OTHER||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.2||0.743|TWO_SIDED|95.0|-0.3|0.4|||ANOVA|||||0.4|-0.3|0.743
72545781|NCT01688037|144621103|OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.2||0.1151|TWO_SIDED|95.0|-0.7|0.1|||ANOVA|||||0.1|-0.7|0.1151
72545782|NCT01688037|144621103|OTHER||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.2||0.0277|TWO_SIDED|95.0|-0.8|0.0|||ANOVA|||||0.0|-0.8|0.0277
72545783|NCT02100956|144621113|SUPERIORITY||||||<|0.05|||||||Mixed Models Analysis|||Null hypothesis was that there was no difference in VAS pain scale scores after intrathecal study drug injection between oxytocin and placebo. To account for repeated measures across time and drug conditions, VAS apin scale scores were analyzed using a linear mixed-effects model with random intercepts at the level of participant. Each outcome was regressed on fixed-effects for order of study day, study drug, time after injection, and drug x time interaction.||||<0.05
72545784|NCT02473991|144621115|SUPERIORITY_OR_OTHER||||||<|0.01|||||||Regression, Linear|||Null hypothesis In normal pregnant women, placental thickness during second trimesters may be correlated with birth weight at term.||||<0.01
72545785|NCT02473991|144621116|SUPERIORITY_OR_OTHER||||||<|0.01|||||||Regression, Linear|||Null hypothesis In normal pregnant women, placental thickness during third trimesters may be correlated with birth weight at term.||||<0.01
72545786|NCT03065283|144621126|EQUIVALENCE|p\< or = 0.05|Mean Difference (Final Values)|0.09||||0.05|TWO_SIDED|95.0|-0.38|0.57|||t-test, 2 sided|||A paired t-test was used for intragroup analysis, and an independent Student's t-test was used for intergroup analysis. Data are represented in mean between-group difference with a 95% CI, and analysis was by intention to treat.||0.57|-0.38|0.05
72411810|NCT00406029|144331716|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.9||||0.173|TWO_SIDED|95.0|-2.3|0.4|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.4|-2.3|0.173
72411811|NCT00406029|144331716|SUPERIORITY_OR_OTHER||Difference in LS Means|0.2||||0.757|TWO_SIDED|94.0|-1.3|1.8|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.8|-1.3|0.757
72545787|NCT00095199|144621130|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.03||||0.756|TWO_SIDED|95.0|0.87|1.21||The 2-sided unstratified log-rank test was employed at the 5% significance level.|Log Rank|Kaplan-Meier method estimated median PFS time. HR was calculated with unstratified Cox proportional hazards model. HR\<1 favours Cetuximab arm||The Pemetrexed comparisons (Cetuximab + Pemetrexed vs Pemetrexed) were considered the primary comparisons. The Docetaxel comparisons (Cetuximab + Docetaxel vs Docetaxel) were considered supportive as Docetaxel comparisons remained underpowered by design. No tests were conducted to compare participants who received Docetaxel to those who received Pemetrexed.||1.21|0.87|0.756
72545788|NCT00095199|144621130|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.91||||0.391|TWO_SIDED|95.0|0.73|1.13||The 2-sided unstratified log-rank test was employed at the 5% significance level.|Log Rank|Kaplan-Meier method estimated median PFS time. HR was calculated with unstratified Cox proportional hazards model. HR\<1 favours Cetuximab arm||The Pemetrexed comparisons (Cetuximab + Pemetrexed vs Pemetrexed) were considered the primary comparisons. The Docetaxel comparisons (Cetuximab + Docetaxel vs Docetaxel) were considered supportive as Docetaxel comparisons remained underpowered by design. No tests were conducted to compare participants who received Docetaxel to those who received Pemetrexed.||1.13|0.73|0.391
72545789|NCT00095199|144621131|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.01||||0.864|TWO_SIDED|95.0|0.86|1.2||The 2-sided unstratified log-rank test was employed at the 5% significance level|Log Rank|Kaplan-Meier method estimated median OS time. HR was calculated with unstratified Cox proportional hazards model. HR\<1 favors Cetuximab arm||The Pemetrexed comparisons (Cetuximab + Pemetrexed vs Pemetrexed) were considered the primary comparisons. The Docetaxel comparisons (Cetuximab + Docetaxel vs Docetaxel) were considered supportive as Docetaxel comparisons remained underpowered by design. No tests were conducted to compare participants who received Docetaxel to those who received Pemetrexed.||1.20|0.86|0.864
72545790|NCT00095199|144621131|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.13||||0.307|TWO_SIDED|95.0|0.9|1.41||The 2-sided unstratified log-rank test was employed at the 5% significance level.|Log Rank|Kaplan-Meier method estimated median OS time. HR was calculated with unstratified Cox proportional hazards model. HR\<1 favors Cetuximab arm||The Pemetrexed comparisons (Cetuximab + Pemetrexed vs Pemetrexed) were considered the primary comparisons. The Docetaxel comparisons (Cetuximab + Docetaxel vs Docetaxel) were considered supportive as Docetaxel comparisons remained underpowered by design. No tests were conducted to compare participants who received Docetaxel to those who received Pemetrexed.||1.41|0.90|0.307
72580301|NCT00143390|144690086|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority of exemestane to anastrozole was to be concluded if the upper bound of the 95% confidence interval on the hazard ratio (exemestane/anastrozole) was ≤1.25.|Hazard Ratio (HR)|1.059|||||TWO_SIDED|95.0|0.816|1.374|||||Disease sites, use of postoperative adjuvant antiestrogen agents therapy, and pamidronate disodium were covariates for adjustment.|95% Confidence Interval based on the Brookmeyer and Crowley method||1.374|0.816|
72580302|NCT03417687|144690094|EQUIVALENCE|The 2 methods were considered equivalent if the 95% confidence interval for the mean within subject difference between 129Xe MRI and 133Xe scintigraphy measurements was contained within the equivalence margin (-14.7%, +14.7%).|Mean Difference (Net)|1.4|STANDARD_DEVIATION|5.9|||TWO_SIDED|95.0|-0.75|3.6||||||The primary efficacy analysis tested the mean difference in the predicted percentage of remaining pulmonary function as measured by 129Xe MRI relative to the value as measured by 133Xe scintigraphy (reference standard) if a pre-defined section of lung were resected.||3.60|-0.75|
72411812|NCT00406029|144331716|SUPERIORITY_OR_OTHER||Difference in LS Means|0.4||||0.581|TWO_SIDED|95.0|-1.1|1.9|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.9|-1.1|0.581
72411813|NCT00406029|144331716|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.0||||0.195|TWO_SIDED|95.0|-2.5|0.5|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.5|-2.5|0.195
72411814|NCT00406029|144331716|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.8||||0.272|TWO_SIDED|95.0|-2.4|0.7|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.7|-2.4|0.272
72411815|NCT00406029|144331716|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.2||||0.758|TWO_SIDED|95.0|-1.7|1.2|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.2|-1.7|0.758
72411816|NCT00406029|144331716|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.6||||0.416|TWO_SIDED|95.0|-2.1|0.9|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.9|-2.1|0.416
72411817|NCT00406029|144331716|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.0||||0.174|TWO_SIDED|95.0|-2.5|0.5|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.5|-2.5|0.174
72411818|NCT00406029|144331716|SUPERIORITY_OR_OTHER||Difference in LS Means|0.5||||0.547|TWO_SIDED|95.0|-1.1|2.0|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.||2.0|-1.1|0.547
72411819|NCT00406029|144331716|SUPERIORITY_OR_OTHER||Difference in LS Means|0.7||||0.372|TWO_SIDED|95.0|-0.8|2.2|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.||2.2|-0.8|0.372
72545791|NCT00095199|144621132|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.59||||0.2|TWO_SIDED|95.0|0.78|3.26||The 2-sided unstratified Mantel Haenszel test was employed at the 5% significance level.|Mantel Haenszel|HR\<1 favors Cetuximab arm||The Pemetrexed comparisons (Cetuximab + Pemetrexed vs Pemetrexed) were considered the primary comparisons. The Docetaxel comparisons (Cetuximab + Docetaxel vs Docetaxel) were considered supportive as Docetaxel comparisons remained underpowered by design. No tests were conducted to compare participants who received Docetaxel to those who received Pemetrexed.||3.26|0.78|0.200
72545792|NCT00095199|144621132|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.19||||0.683|TWO_SIDED|95.0|0.52|2.74||The 2-sided unstratified Mantel Haenszel test was employed at the 5% significance level.|Mantel Haenszel|HR\<1 favors Cetuximab arm||The Pemetrexed comparisons (Cetuximab + Pemetrexed vs Pemetrexed) were considered the primary comparisons. The Docetaxel comparisons (Cetuximab + Docetaxel vs Docetaxel) were considered supportive as Docetaxel comparisons remained underpowered by design. No tests were conducted to compare participants who received Docetaxel to those who received Pemetrexed.||2.74|0.52|0.683
72545793|NCT00095199|144621133|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.18||||0.31|TWO_SIDED|95.0|0.86|1.62||The 2-sided unstratified Mantel Haenszel test was employed at the 5% significance level.|Mantel Haenszel|HR\<1 favors Cetuximab arm||The Pemetrexed comparisons (Cetuximab + Pemetrexed vs Pemetrexed) were considered the primary comparisons. The Docetaxel comparisons (Cetuximab + Docetaxel vs Docetaxel) were considered supportive as Docetaxel comparisons remained underpowered by design. No tests were conducted to compare participants who received Docetaxel to those who received Pemetrexed.||1.62|0.86|0.310
72545794|NCT00095199|144621133|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.49||||0.1|TWO_SIDED|95.0|0.93|2.4||The 2-sided unstratified Mantel Haenszel test was employed at the 5% significance level.|Mantel Haenszel|HR\<1 favors Cetuximab arm||The Pemetrexed comparisons (Cetuximab + Pemetrexed vs Pemetrexed) were considered the primary comparisons. The Docetaxel comparisons (Cetuximab + Docetaxel vs Docetaxel) were considered supportive as Docetaxel comparisons remained underpowered by design. No tests were conducted to compare participants who received Docetaxel to those who received Pemetrexed.||2.40|0.93|0.100
72552611|NCT02728102|144636043|SUPERIORITY|||||||0.7379||||||Statistical significance was determined using a pre-specified threshold of 0.05.|Chi-squared|||In this pairwise analysis, the proportion of participants alive and with sCR/CR/VGPR will be compared between the vaccine arm and lenalidomide alone arm at 2 years Post Transplant.||||0.7379
72411820|NCT00406029|144331716|SUPERIORITY_OR_OTHER||Difference in LS Means|0.1||||0.942|TWO_SIDED|95.0|-1.4|1.5|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.5|-1.4|0.942
72411821|NCT00406029|144331716|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.3||||0.082|TWO_SIDED|95.0|-2.8|0.2|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.2|-2.8|0.082
72411822|NCT00406029|144331716|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.8||||0.267|TWO_SIDED|95.0|-2.3|0.6|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.6|-2.3|0.267
72411823|NCT00406029|144331716|SUPERIORITY_OR_OTHER||Difference in LS Means|0.2||||0.801|TWO_SIDED|95.0|-1.5|1.9|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.9|-1.5|0.801
72411824|NCT00406029|144331716|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.3||||0.753|TWO_SIDED|95.0|-1.9|1.4|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.4|-1.9|0.753
72411825|NCT00406029|144331716|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.4||||0.087|TWO_SIDED|95.0|-3.1|0.2|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.2|-3.1|0.087
72411826|NCT00406029|144331716|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.2||||0.796|TWO_SIDED|95.0|-1.9|1.4|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.4|-1.9|0.796
72411827|NCT00406029|144331716|SUPERIORITY_OR_OTHER||Difference in LS Means|0.4||||0.621|TWO_SIDED|95.0|-1.3|2.1|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.||2.1|-1.3|0.621
72411828|NCT00406029|144331716|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.2||||0.784|TWO_SIDED|95.0|-1.8|1.4|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.4|-1.8|0.784
72411829|NCT00406029|144331716|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.9||||0.024|TWO_SIDED|95.0|-3.5|-0.2|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.||-0.2|-3.5|0.024
72411830|NCT00406029|144331716|SUPERIORITY_OR_OTHER||Difference in LS Means|0.0||||0.963|TWO_SIDED|95.0|-1.6|1.6|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.6|-1.6|0.963
72411831|NCT00406029|144331716|SUPERIORITY_OR_OTHER||Difference in LS Means|0.7||||0.331|TWO_SIDED|95.0|-0.8|2.3|||ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.||2.3|-0.8|0.331
72411832|NCT00406029|144331716|SUPERIORITY_OR_OTHER||Difference in LS Means|0.1||||0.898|TWO_SIDED|95.0|-1.4|1.6|||ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.6|-1.4|0.898
72411833|NCT00406029|144331716|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.5||||0.058|TWO_SIDED|95.0|-3.0|0.0|||ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.0|-3.0|0.058
72411834|NCT00406029|144331716|SUPERIORITY_OR_OTHER||Difference in LS Means|0.2||||0.832|TWO_SIDED|95.0|-1.3|1.7|||ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.7|-1.3|0.832
72411835|NCT00406029|144331717|SUPERIORITY_OR_OTHER||Difference in LS Means|1.7||||0.365|TWO_SIDED|95.0|-2.0|5.3|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.||5.3|-2.0|0.365
72545795|NCT00095199|144621134|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.7||||0.091|TWO_SIDED|95.0|0.46|1.06||The 2-sided unstratified Mantel Haenszel test was employed at the 5% significance level.|Mantel Haenszel|HR\<1 favors Cetuximab arm||The Pemetrexed comparisons (Cetuximab + Pemetrexed vs Pemetrexed) were considered the primary comparisons. The Docetaxel comparisons (Cetuximab + Docetaxel vs Docetaxel) were considered supportive as Docetaxel comparisons remained underpowered by design. No tests were conducted to compare participants who received Docetaxel to those who received Pemetrexed.||1.06|0.46|0.091
72411836|NCT00406029|144331717|SUPERIORITY_OR_OTHER||Difference in LS Means|1.4||||0.476|TWO_SIDED|95.0|-2.4|5.1|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.||5.1|-2.4|0.476
72411837|NCT00406029|144331717|SUPERIORITY_OR_OTHER||Difference in LS Means|1.8||||0.343|TWO_SIDED|95.0|-2.0|5.6|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.||5.6|-2.0|0.343
72411838|NCT00406029|144331717|SUPERIORITY_OR_OTHER||Difference in LS Means|-3.1||||0.103|TWO_SIDED|95.0|-6.8|0.6|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.6|-6.8|0.103
72411839|NCT00406029|144331717|SUPERIORITY_OR_OTHER||Difference in LS Means|-2.3||||0.224|TWO_SIDED|94.0|-6.0|1.4|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.4|-6.0|0.224
72580303|NCT03417687|144690096|EQUIVALENCE|The 2 methods were considered equivalent if the 95% confidence interval for the mean within subject difference between 129Xe MRI and 133Xe scintigraphy measurements was contained within the equivalence margin (-5.0%, +5.0%).|Mean Difference (Final Values)|3.71|STANDARD_DEVIATION|4.39|||TWO_SIDED|95.0|2.12|5.29||||||||5.29|2.12|
72580304|NCT03417687|144690097|EQUIVALENCE|The 2 methods were considered equivalent if the 95% confidence interval for the mean within subject difference between 129Xe MRI and 133Xe scintigraphy measurements was contained within the equivalence margin (-5.0%, +5.0%).|Mean Difference (Final Values)|0.39|STANDARD_DEVIATION|2.4|||TWO_SIDED|95.0|-0.476|1.26||||||||1.26|-0.476|
72411840|NCT00406029|144331717|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.4||||0.448|TWO_SIDED|95.0|-5.1|2.2|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.||2.2|-5.1|0.448
72411841|NCT00406029|144331717|SUPERIORITY_OR_OTHER||Difference in LS Means|-2.7||||0.154|TWO_SIDED|95.0|-6.4|1.0|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.0|-6.4|0.154
72411842|NCT00406029|144331717|SUPERIORITY_OR_OTHER||Difference in LS Means|-4.8||||0.01|TWO_SIDED|95.0|-8.5|-1.1|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.||-1.1|-8.5|0.010
72411843|NCT00406029|144331717|SUPERIORITY_OR_OTHER||Difference in LS Means|1.2||||0.54|TWO_SIDED|95.0|-2.6|5.0|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.||5.0|-2.6|0.540
72411844|NCT00406029|144331717|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.9||||0.646|TWO_SIDED|95.0|-4.7|2.9|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.||2.9|-4.7|0.646
72411845|NCT00406029|144331717|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.0||||0.608|TWO_SIDED|95.0|-4.9|2.9|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.||2.9|-4.9|0.608
72411846|NCT00406029|144331717|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.9||||0.343|TWO_SIDED|95.0|-6.0|2.1|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.||2.1|-6.0|0.343
72411847|NCT00406029|144331717|SUPERIORITY_OR_OTHER||Difference in LS Means|1.7||||0.419|TWO_SIDED|95.0|-2.5|5.9|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.||5.9|-2.5|0.419
72411848|NCT00406029|144331717|SUPERIORITY_OR_OTHER||Difference in LS Means|1.1||||0.562|TWO_SIDED|95.0|-2.8|5.1|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.||5.1|-2.8|0.562
72411849|NCT00406029|144331717|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.3||||0.525|TWO_SIDED|95.0|-5.3|2.7|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.||2.7|-5.3|0.525
72545796|NCT00095199|144621134|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.34||||0.361|TWO_SIDED|95.0|0.72|2.5||The 2-sided unstratified Mantel Haenszel test was employed at the 5% significance level.|Mantel Haenszel|HR\<1 favors Cetuximab arm||The Pemetrexed comparisons (Cetuximab + Pemetrexed vs Pemetrexed) were considered the primary comparisons. The Docetaxel comparisons (Cetuximab + Docetaxel vs Docetaxel) were considered supportive as Docetaxel comparisons remained underpowered by design. No tests were conducted to compare participants who received Docetaxel to those who received Pemetrexed.||2.50|0.72|0.361
72545797|NCT00095199|144621135|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.16||||0.472|TWO_SIDED|95.0|0.77|1.74||The 2-sided unstratified log-rank test was employed at the 5% significance level.|Log Rank|Kaplan-Meier estimated time to symptomatic progression. HR was calculated using unstratified Cox proportional hazards model. HR\<1 favors Cetuximab arm||The Pemetrexed comparisons (Cetuximab + Pemetrexed vs Pemetrexed) were considered the primary comparisons. The Docetaxel comparisons (Cetuximab + Docetaxel vs Docetaxel) were considered supportive as Docetaxel comparisons remained underpowered by design. No tests were conducted to compare participants who received Docetaxel to those who received Pemetrexed.||1.74|0.77|0.472
72545798|NCT00095199|144621135|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.73||||0.272|TWO_SIDED|95.0|0.42|1.27||The 2-sided unstratified log-rank test was employed at the 5% significance level.|Log Rank|Kaplan-Meier estimated time to symptomatic progression. HR was calculated using unstratified Cox proportional hazards model. HR\<1 favors Cetuximab arm||The Pemetrexed comparisons (Cetuximab + Pemetrexed vs Pemetrexed) were considered the primary comparisons. The Docetaxel comparisons (Cetuximab + Docetaxel vs Docetaxel) were considered supportive as Docetaxel comparisons remained underpowered by design. No tests were conducted to compare participants who received Docetaxel to those who received Pemetrexed.||1.27|0.42|0.272
72552612|NCT02728102|144636043|SUPERIORITY|||||||0.2379||||||Statistical significance was determined using a pre-specified threshold of 0.05.|Chi-squared|||In this pairwise analysis, the proportion of participants alive and with sCR/CR/VGPR will be compared between the lenalidomide/GM-CSF arm and lenalidomide alone arm at 2 years Post Transplant.||||0.2379
72411850|NCT00406029|144331717|SUPERIORITY_OR_OTHER||Difference in LS Means|-3.0||||0.148|TWO_SIDED|95.0|-7.0|1.1|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.1|-7.0|0.148
72411851|NCT00406029|144331717|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.3||||0.546|TWO_SIDED|95.0|-5.4|2.9|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.||2.9|-5.4|0.546
72411852|NCT00406029|144331717|SUPERIORITY_OR_OTHER||Difference in LS Means|-3.7||||0.068|TWO_SIDED|95.0|-7.6|0.3|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.3|-7.6|0.068
72552613|NCT02728102|144636043|SUPERIORITY|||||||0.5353||||||Statistical significance was determined using a pre-specified threshold of 0.05|Chi-squared|||Proportion of participants achieving CR among the subset of participants who are not in CR at the time of randomization between the vaccine and the combined non-vaccine arms at 6 months Post Transplant.||||0.5353
72545799|NCT00095199|144621136|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.58||||0.236|TWO_SIDED|95.0|0.74|3.36||The 2-sided unstratified log-rank test was employed at the 5% significance level.|Log Rank|The Kaplan-Meier method estimated duration of response. HR was calculated using unstratified Cox proportional hazards model. HR\<1 favors Cetuximab arm||The Pemetrexed comparisons (Cetuximab + Pemetrexed vs Pemetrexed) were considered the primary comparisons. The Docetaxel comparisons (Cetuximab + Docetaxel vs Docetaxel) were considered supportive as Docetaxel comparisons remained underpowered by design. No tests were conducted to compare participants who received Docetaxel to those who received Pemetrexed.||3.36|0.74|0.236
72545800|NCT00095199|144621136|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.96||||0.887|TWO_SIDED|95.0|0.42|2.18||The 2-sided unstratified log-rank test was employed at the 5% significance level.|Log Rank|The Kaplan-Meier method estimated duration of response. HR was calculated using unstratified Cox proportional hazards model. HR\<1 favors Cetuximab arm||The Pemetrexed comparisons (Cetuximab + Pemetrexed vs Pemetrexed) were considered the primary comparisons. The Docetaxel comparisons (Cetuximab + Docetaxel vs Docetaxel) were considered supportive as Docetaxel comparisons remained underpowered by design. No tests were conducted to compare participants who received Docetaxel to those who received Pemetrexed.||2.18|0.42|0.887
72545801|NCT01070394|144621157|SUPERIORITY_OR_OTHER||||||<|0.001|||||||GEE regression model|Generalized Estimating Equation (GEE)||||||<.001
72545802|NCT01070394|144621158|SUPERIORITY_OR_OTHER|||||||0.569|||||||GEE regression model|Generalized Estimating Equation (GEE)||||||.569
72545803|NCT01070394|144621158|SUPERIORITY_OR_OTHER|||||||0.827|||||||Generalized Estimating Equation|||The following p-value is for AMSES In-Clinic, a subset of the overall AMSES||||.827
72545804|NCT01070394|144621158|SUPERIORITY_OR_OTHER|||||||0.569|||||||Generalized Estimating Equation|||The following p-value is for AMSES, Evening, a subset of the AMSES||||.569
72545805|NCT01070394|144621159|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED||||||GEE regression model|Generalized Estimating Equation (GEE)||||||.001
72545806|NCT01070394|144621160|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||GEE regression model|||||||<.001
72580305|NCT03417687|144690098|EQUIVALENCE|The 2 methods were considered equivalent if the 95% confidence interval for the mean within subject difference between 129Xe MRI and 133Xe scintigraphy measurements was contained within the equivalence margin (-5.0%, +5.0%).|Mean Difference (Final Values)|1.35|STANDARD_DEVIATION|3.22|||TWO_SIDED|95.0|0.184|2.505||||||||2.505|0.184|
72545807|NCT01070394|144621161|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||GEE regression model|Generalized Estimating Equation (GEE)||||||<.0001
72580306|NCT03417687|144690099|EQUIVALENCE|The 2 methods were considered equivalent if the 95% confidence interval for the mean within subject difference between 129Xe MRI and 133Xe scintigraphy measurements was contained within the equivalence margin (-5.0%, +5.0%).|Mean Difference (Final Values)|-0.96|STANDARD_DEVIATION|3.16|||TWO_SIDED|95.0|-2.101|0.181||||||||0.181|-2.101|
72545808|NCT01070394|144621162|SUPERIORITY_OR_OTHER|||||||0.001|||||||GEE regression model|Generalized Estimating Equation (GEE)||||||0.001
72545809|NCT03280537|144621165|SUPERIORITY||Difference in Least Squares Means|-0.59|STANDARD_ERROR_OF_MEAN|0.23||0.014|TWO_SIDED|95.0|-1.05|-0.12||Tested at the two-sided 0.05 significance level. There was no adjustment for multiplicity for the co-primary outcome measures.|Mixed-Effect Model of Repeated Measures|Adjustments: geographic region, asthma/aspirin sensitivity, treatment, timepoint, baseline NPS, treatment and baseline NPS by timepoint interactions.|Difference in least squares means: Omalizumab arm minus Placebo arm.|The primary analysis tested the null hypothesis that no treatment group difference existed for change from baseline in NPS at Week 24. As NPS and NCS are co-primary outcome measures, both null hypotheses for NPS and NCS must be rejected, with parameter estimates indicating a benefit of omalizumab over placebo, for the study to be deemed positive.||-0.12|-1.05|0.0140
72545810|NCT03280537|144621166|SUPERIORITY||Difference in Least Squares Means|-0.5|STANDARD_ERROR_OF_MEAN|0.15||0.0017|TWO_SIDED|95.0|-0.8|-0.19||Tested at the two-sided 0.05 significance level. There was no adjustment for multiplicity for the co-primary outcome measures.|Mixed-Effect Model of Repeated Measures|Adjustments: geographic region, asthma/aspirin sensitivity, treatment, timepoint, baseline NCS, treatment and baseline NCS by timepoint interactions.|Difference in least squares means: Omalizumab arm minus Placebo arm.|The primary analysis tested the null hypothesis that no treatment group difference existed for change from baseline in NCS at Week 24. As NPS and NCS are co-primary outcome measures, both null hypotheses for NPS and NCS must be rejected, with parameter estimates indicating a benefit of omalizumab over placebo, for the study to be deemed positive.||-0.19|-0.80|0.0017
72545811|NCT03280537|144621167|SUPERIORITY||Difference in Least Squares Means|-0.45|STANDARD_ERROR_OF_MEAN|0.14||0.0024|TWO_SIDED|95.0|-0.73|-0.16||Tested at the two-sided 0.05 significance level.|Mixed-Effect Model of Repeated Measures|Adjustments: geographic region, asthma/aspirin sensitivity, treatment, timepoint, baseline SSS, treatment and baseline SSS by timepoint interactions.|Difference in least squares means: Omalizumab arm minus Placebo arm.|The null hypothesis was that no difference exists between the treatment groups for change from baseline in the average daily Sense of Smell Score (SSS) at Week 24.||-0.16|-0.73|0.0024
72545812|NCT03280537|144621168|SUPERIORITY||Difference in Least Squares Means|-0.54|STANDARD_ERROR_OF_MEAN|0.14||0.0001|TWO_SIDED|95.0|-0.81|-0.27||Tested at the two-sided 0.05 significance level.|Mixed-Effect Model of Repeated Measures|Adjustments: geographic region, asthma/aspirin sensitivity, treatment, timepoint, baseline PRS, treatment and baseline PRS by timepoint interactions.|Difference in least squares means: Omalizumab arm minus Placebo arm.|The null hypothesis was that no difference exists between the treatment groups for change from baseline in the average daily Posterior Rhinorrhea Score (PRS) at Week 24.||-0.27|-0.81|0.0001
72411853|NCT00406029|144331717|SUPERIORITY_OR_OTHER||Difference in LS Means|-2.5||||0.208|TWO_SIDED|95.0|-6.5|1.4|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.4|-6.5|0.208
72545813|NCT03280537|144621169|SUPERIORITY||Difference in Least Squares Means|-0.91|STANDARD_ERROR_OF_MEAN|0.24||0.0002|TWO_SIDED|95.0|-1.39|-0.44||Tested at the two-sided 0.05 significance level.|Mixed-Effect Model of Repeated Measures|Adjustments: geographic region, asthma/aspirin sensitivity, treatment, timepoint, baseline NPS, treatment and baseline NPS by timepoint interactions.|Difference in least squares means: Omalizumab arm minus Placebo arm.|The null hypothesis was that no difference exists between the treatment groups for change from baseline in the NPS at Week 16.||-0.44|-1.39|0.0002
72545814|NCT03280537|144621170|SUPERIORITY||Difference in Least Squares Means|-0.59|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-0.87|-0.3||Tested at the two-sided 0.05 significance level.|Mixed-Effect Model of Repeated Measures|Adjustments: geographic region, asthma/aspirin sensitivity, treatment, timepoint, baseline NCS, treatment and baseline NCS by timepoint interactions.|Difference in least squares means: Omalizumab arm minus Placebo arm.|The null hypothesis was that no difference exists between the treatment groups for change from baseline in the average daily NCS at Week 16.||-0.30|-0.87|<0.0001
72545815|NCT03280537|144621171|SUPERIORITY||Difference in Least Squares Means|-15.04|STANDARD_ERROR_OF_MEAN|3.14|<|0.0001|TWO_SIDED|95.0|-21.26|-8.82||Tested at the two-sided 0.05 significance level.|Mixed-Effect Model of Repeated Measures|Adjustments: geographic region, asthma/aspirin sensitivity, treatment, timepoint, baseline, treatment and baseline by timepoint interactions.|Difference in least squares means: Omalizumab arm minus Placebo arm.|The null hypothesis was that no difference exists between the treatment groups for change from baseline in the SNOT-22 score at Week 24.||-8.82|-21.26|<0.0001
72545816|NCT03280537|144621172|SUPERIORITY||Difference in Least Squares Means|-0.63|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-0.9|-0.35||Tested at the two-sided 0.05 significance level.|Mixed-Effect Model of Repeated Measures|Adjustments: geographic region, asthma/aspirin sensitivity, treatment, timepoint, baseline ARS, treatment and baseline ARS by timepoint interactions.|Difference in least squares means: Omalizumab arm minus Placebo arm.|The null hypothesis was that no difference exists between the treatment groups for change from baseline in the average daily Anterior Rhinorrhea Score (ARS) at Week 24.||-0.35|-0.90|<0.0001
72545817|NCT03280537|144621173|SUPERIORITY||Odds Ratio (OR)|0.2||||0.1594|TWO_SIDED|95.0|0.02|1.89||Tested at the two-sided 0.05 significance level.|Wald Chi-Square|Adjusted for geographic region and asthma/aspirin sensitivity comorbidity status.|Odds ratio is comparing Omalizumab arm to Placebo arm.|The null hypothesis was that no difference exists between the treatment groups for requirement of rescue medication through Week 24.||1.89|0.02|0.1594
72545818|NCT03280537|144621174|SUPERIORITY||Odds Ratio (OR)|0.0||||1|TWO_SIDED|95.0|0.0|20.61||Tested at the two-sided 0.05 significance level.|Fisher Exact|Unadjusted|Odds ratio is comparing Omalizumab arm to Placebo arm.|The null hypothesis was that no difference exists between the treatment groups for having had surgery for nasal polyps through Week 24.||20.61|0.00|1.0000
72545819|NCT03280537|144621175|SUPERIORITY||Odds Ratio (OR)|4.04||||0.0396|TWO_SIDED|95.0|1.07|15.25|||Wald Chi-Square|Adjusted for Baseline AQLQ, geographic region, and aspirin sensitivity status.|Odds ratio is comparing Omalizumab arm to Placebo arm.|The null hypothesis was that no difference exists between the treatment groups for number of participants with a change from baseline in AQLQ score of ≥0.5 at Week 24.||15.25|1.07|0.0396
72545820|NCT03280537|144621176|SUPERIORITY||Odds Ratio (OR)|0.2||||0.1594|TWO_SIDED|95.0|0.02|1.89||Tested at the two-sided 0.05 significance level.|Wald Chi-Square|Adjusted for geographic region and asthma/aspirin sensitivity comorbidity status.|Odds ratio is comparing Omalizumab arm to Placebo arm.|The null hypothesis was that no difference exists between the treatment groups for requirement of rescue treatment through Week 24.||1.89|0.02|0.1594
72545821|NCT03280537|144621177|SUPERIORITY||Odds Ratio (OR)|6.22||||0.0139|TWO_SIDED|95.0|1.23|60.23||Tested at the two-sided 0.05 significance level.|Fisher Exact|Unadjusted|Odds ratio is comparing Omalizumab arm to Placebo arm.|The null hypothesis was that no difference exists between the treatment groups for change from baseline in reduction in the need for surgery for nasal polyps by Week 24.||60.23|1.23|0.0139
72545822|NCT03280537|144621178|SUPERIORITY||Difference in Least Squares Means|-2.09|STANDARD_ERROR_OF_MEAN|0.46|<|0.0001|TWO_SIDED|95.0|-3.0|-1.18||Tested at the two-sided 0.05 significance level.|Mixed-Effect Model of Repeated Measures|Adjustments: geographic region, asthma/aspirin sensitivity, treatment, timepoint, baseline TNSS, treatment and baseline by timepoint interactions.|Difference in least squares means: Omalizumab arm minus Placebo arm.|The null hypothesis was that no difference exists between the treatment groups for change from baseline in the average daily Total Nasal Symptom Score (TNSS) at Week 24.||-1.18|-3.00|<0.0001
72545823|NCT03280537|144621179|SUPERIORITY||Difference in Least Squares Means|3.86|STANDARD_ERROR_OF_MEAN|1.16||0.0011|TWO_SIDED|95.0|1.57|6.15||Tested at the two-sided 0.05 significance level.|Mixed-Effect Model of Repeated Measures|Adjustments: geographic region, asthma/aspirin sensitivity, treatment, timepoint, baseline UPSIT, treatment and baseline by timepoint interactions.|Difference in least squares means: Omalizumab arm minus Placebo arm|The null hypothesis was that no difference exists between the treatment groups for change from baseline in the UPSIT score at Week 24.||6.15|1.57|0.0011
72545824|NCT03118739|144621195|SUPERIORITY||Mean % Change from Baseline|-39.37|||||TWO_SIDED|90.0|-61.785|-3.814||||||||-3.814|-61.785|
72545825|NCT00461500|144621327|SUPERIORITY_OR_OTHER||Mean Difference (Net)|7.23|STANDARD_ERROR_OF_MEAN|17.6||0.683||95.0|-27.96|42.43|||ANCOVA||mean difference = drug SFC 100 minus FP 100|||42.43|-27.96|0.683
72545826|NCT01806597|144621340|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|19.3||||0.0002|TWO_SIDED|95.0|2.4|154.6|||Cochran-Mantel-Haenszel|||Data at Week 16 was analyzed using the stratified Cochran-Mantel-Haenszel-test. The test was stratified by body-weight category (\<90 kg or ≥90 kg).||154.6|2.4|0.0002
72545827|NCT01806597|144621340|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|29.4|||<|0.0001|TWO_SIDED|95.0|4.1|211.9|||Cochran-Mantel-Haenszel|||Data at Week 16 was analyzed using the stratified Cochran-Mantel-Haenszel-test. The test was stratified by body-weight category (\<90 kg or ≥90 kg).||211.9|4.1|<0.0001
72545828|NCT02247479|144621350|SUPERIORITY||Difference in Adjusted Means|-0.019||||0.8381|TWO_SIDED|95.0|-0.206|0.167|||MMRM|||Week 48: MMRM analysis uses change as response variable and included treatment group, visit, treatment-by-visit interaction, baseline GA area, lesion location, contiguity, biomarker status, modified baseline BCVA and sex.||0.167|-0.206|0.8381
72580307|NCT03417687|144690100|EQUIVALENCE|The 2 methods were considered equivalent if the 95% confidence interval for the mean within subject difference between 129Xe MRI and 133Xe scintigraphy measurements was contained within the equivalence margin (-5.0%, +5.0%).|Mean Difference (Final Values)|-2.721|STANDARD_DEVIATION|3.82|||TWO_SIDED|95.0|-4.096|-1.345||||||||-1.345|-4.096|
72411854|NCT00406029|144331717|SUPERIORITY_OR_OTHER||Difference in LS Means|-3.4||||0.099|TWO_SIDED|95.0|-7.5|0.6|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.6|-7.5|0.099
72411855|NCT00406029|144331717|SUPERIORITY_OR_OTHER||Difference in LS Means|0.8||||0.731|TWO_SIDED|95.0|-3.6|5.1|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.||5.1|-3.6|0.731
72545829|NCT02247479|144621350|SUPERIORITY||Difference in Adjusted Means|0.051||||0.5901|TWO_SIDED|95.0|-0.134|0.236|||MMRM|||Week 48: MMRM analysis uses change as response variable and included treatment group, visit, treatment-by-visit interaction, baseline GA area, lesion location, contiguity, biomarker status, modified baseline BCVA and sex.||0.236|-0.134|0.5901
72545830|NCT02247479|144621351|SUPERIORITY||Difference in Adjusted Means|-0.2||||0.935|TWO_SIDED|95.0|-5.2|4.8|||MMRM|||Week 48: MMRM analysis uses change as response variable and included treatment group, visit, treatment-by-visit interaction, baseline number of absolute scotomatous points, GA lesion location, contiguity, biomarker status, modified baseline BCVA and sex.||4.8|-5.2|0.9350
72545831|NCT02247479|144621351|SUPERIORITY||Difference in Adjusted Means|0.1||||0.9789|TWO_SIDED|95.0|-5.0|5.2|||MMRM|||Week 48: MMRM analysis uses change as response variable and included treatment group, visit, treatment-by-visit interaction, baseline number of absolute scotomatous points, GA lesion location, contiguity, biomarker status, modified baseline BCVA and sex.||5.2|-5.0|0.9789
72545832|NCT02247479|144621352|SUPERIORITY||Difference in Adjusted Means|0.28||||0.5538|TWO_SIDED|95.0|-0.66|1.22|||MMRM|||Week 48: MMRM analysis uses change as response variable and included treatment group, visit, treatment-by-visit interaction, baseline mean macular sensitivity, GA lesion location, contiguity, biomarker status, modified baseline BCVA and sex.||1.22|-0.66|0.5538
72545833|NCT02247479|144621352|SUPERIORITY||Difference in Adjusted Means|-0.63||||0.2032|TWO_SIDED|95.0|-1.6|0.35|||MMRM|||Week 48: MMRM analysis uses change as response variable and included treatment group, visit, treatment-by-visit interaction, baseline mean macular sensitivity, GA lesion location, contiguity, biomarker status, modified baseline BCVA and sex.||0.35|-1.60|0.2032
72545834|NCT02247479|144621353|SUPERIORITY||Difference in Adjusted Means|1.0||||0.2547|TWO_SIDED|95.0|-0.7|2.8|||MMRM|||Week 48: MMRM analysis uses change as response variable and included treatment group, visit, treatment-by-visit interaction, baseline BCVA, GA lesion location, biomarker status, and sex.||2.8|-0.7|0.2547
72545835|NCT02247479|144621353|SUPERIORITY||Difference in Adjusted Means|-0.2||||0.8423|TWO_SIDED|95.0|-1.9|1.6|||MMRM|||Week 48: MMRM analysis uses change as response variable and included treatment group, visit, treatment-by-visit interaction, baseline BCVA, GA lesion location, biomarker status, and sex.||1.6|-1.9|0.8423
72545836|NCT02247479|144621354|SUPERIORITY||Odds Ratio (OR)|1.3||||0.3248|TWO_SIDED|95.0|0.8|2.2|||Regression, Logistic|||Week 48: The adjusted analysis was based on a logistic regression analysis. The model included terms for treatment group, baseline BCVA, baseline GA lesion location, biomarker status, and sex.||2.2|0.8|0.3248
72545837|NCT02247479|144621354|SUPERIORITY||Odds Ratio (OR)|1.1||||0.7209|TWO_SIDED|95.0|0.7|1.8|||Regression, Logistic|||Week 48: The adjusted analysis was based on a logistic regression analysis. The model included terms for treatment group, baseline BCVA, baseline GA lesion location, biomarker status, and sex.||1.8|0.7|0.7209
72545838|NCT02247479|144621355|SUPERIORITY||Difference in Adjusted Means|0.6||||0.5695|TWO_SIDED|95.0|-1.4|2.6|||MMRM|||Week 48: MMRM analysis uses change as response variable and included treatment group, visit, treatment-by-visit interaction, baseline LLVA, GA lesion location, biomarker status, modified baseline BCVA ETDRS chart Snellen equivalent category, and sex.||2.6|-1.4|0.5695
72545839|NCT02247479|144621355|SUPERIORITY||Difference in Adjusted Means|0.3||||0.7865|TWO_SIDED|95.0|-1.7|2.3|||MMRM|||Week 48: MMRM analysis uses change as response variable and included treatment group, visit, treatment-by-visit interaction, baseline LLVA, GA lesion location, biomarker status, modified baseline BCVA ETDRS chart Snellen equivalent category, and sex.||2.3|-1.7|0.7865
72545840|NCT02247479|144621356|SUPERIORITY||Odds Ratio (OR)|1.0||||0.9448|TWO_SIDED|95.0|0.6|1.7|||Regression, Logistic|||Week 48: The adjusted analysis was based on a logistic regression analysis. The model included terms for treatment group, baseline LLVA, baseline GA lesion location, biomarker status, modified baseline BCVA ETDRS chart Snellen equivalent category, and sex.||1.7|0.6|0.9448
72545841|NCT02247479|144621356|SUPERIORITY||Odds Ratio (OR)|1.0||||0.8764|TWO_SIDED|95.0|0.6|1.8|||Regression, Logistic|||Week 48: The adjusted analysis was based on a logistic regression analysis. The model included terms for treatment group, baseline LLVA, baseline GA lesion location, biomarker status, modified baseline BCVA ETDRS chart Snellen equivalent category, and sex.||1.8|0.6|0.8764
72545842|NCT02247479|144621357|SUPERIORITY||Difference in Adjusted Means|5.66||||0.0991|TWO_SIDED|95.0|-1.07|12.38|||MMRM|||Week 48: MMRM analysis uses change as response variable and included treatment group, baseline maximum reading speed, type of reading charts, baseline BCVA of better seeing eye, biomarker status, and sex.||12.38|-1.07|0.0991
72545843|NCT02247479|144621357|SUPERIORITY||Difference in Adjusted Means|-0.99||||0.7713|TWO_SIDED|95.0|-7.66|5.69|||MMRM|||Week 48: MMRM analysis uses change as response variable and included treatment group, baseline maximum reading speed, type of reading charts, baseline BCVA of better seeing eye, biomarker status, and sex.||5.69|-7.66|0.7713
72545844|NCT02247479|144621358|SUPERIORITY||Difference in Adjusted Means|1.72||||0.6204|TWO_SIDED|95.0|-5.09|8.53|||MMRM|||MMRM analysis uses change as response variable included terms for treatment group, baseline maximum reading speed, type of reading charts, biomarker status, modified baseline BCVA and sex.||8.53|-5.09|0.6204
72545845|NCT02247479|144621358|SUPERIORITY||Difference in Adjusted Means|1.47||||0.6705|TWO_SIDED|95.0|-5.31|8.25|||MMRM|||MMRM analysis uses change as response variable included terms for treatment group, baseline maximum reading speed, type of reading charts, biomarker status, modified baseline BCVA and sex.||8.25|-5.31|0.6705
72545846|NCT02247479|144621359|SUPERIORITY||Difference in Adjusted Means|-0.36||||0.7246|TWO_SIDED|95.0|-2.35|1.64|||MMRM|||Week 48: MMRM analysis uses change as response variable and included treatment group, baseline score, baseline BCVA of better seeing eye, biomarker status, and sex.||1.64|-2.35|0.7246
72545847|NCT02247479|144621359|SUPERIORITY||Difference in Adjusted Means|-1.56||||0.1193|TWO_SIDED|95.0|-3.53|0.4|||MMRM|||Week 48: MMRM analysis uses change as response variable and included treatment group, baseline score, baseline BCVA of better seeing eye, biomarker status, and sex.||0.40|-3.53|0.1193
72545848|NCT02247479|144621360|SUPERIORITY||Difference in Adjusted Means|-0.22||||0.8659|TWO_SIDED|95.0|-2.84|2.39|||MMRM|||Week 48: MMRM analysis uses change as response variable and included treatment group, baseline score, baseline BCVA of better seeing eye, biomarker status, and sex.||2.39|-2.84|0.8659
72545849|NCT02247479|144621360|SUPERIORITY||Difference in Adjusted Means|-1.94||||0.1399|TWO_SIDED|95.0|-4.51|0.64|||MMRM|||Week 48: MMRM analysis uses change as response variable and included treatment group, baseline score, baseline BCVA of better seeing eye, biomarker status, and sex.||0.64|-4.51|0.1399
72545850|NCT02247479|144621361|SUPERIORITY||Difference in Adjusted Means|0.99||||0.4855|TWO_SIDED|95.0|-1.79|3.76|||MMRM|||Week 48: MMRM analysis uses change as response variable and included treatment group, baseline score, baseline BCVA of better seeing eye, biomarker status, and sex.||3.76|-1.79|0.4855
72580308|NCT03417687|144690101|EQUIVALENCE|The 2 methods were considered equivalent if the 95% confidence interval for the mean within subject difference between 129Xe MRI and 133Xe scintigraphy measurements was contained within the equivalence margin (-5.0%, +5.0%).|Mean Difference (Final Values)|-1.76|STANDARD_DEVIATION|3.96|||TWO_SIDED|95.0|-3.192|-0.335||||||||-0.335|-3.192|
72580309|NCT00866359|144690102|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-1.6|||<|0.0001|TWO_SIDED|95.0|-2.4|-0.9|||ANCOVA||Based on an analysis of covariance model for the number of ulcers at Day 85, with treatment group and gender as factors and the baseline ulcer number as a covariate.|||-0.9|-2.4|<0.0001
72580310|NCT00866359|144690103|SUPERIORITY_OR_OTHER_LEGACY||Least Squares mean difference|-26.8|||<|0.0001|TWO_SIDED|95.0|-35.5|-18.0|||ANCOVA||Based on an analysis of covariance model for the oral ulcer pain VAS at Day 85, with treatment group and gender as factors and the baseline oral ulcer pain VAS as a covariate.|||-18.0|-35.5|<0.0001
72580311|NCT00866359|144690106|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-90.07|||<|0.0001|TWO_SIDED|95.0|-125.32|-54.82||The last post-baseline observation was carried forward to Day 85 for participants who discontinued the study before Day 85. For participants who did not have Day 85 visit on the targeted date, the total AUC was adjusted by the actual study days.|ANCOVA||Based on an analysis of covariance model for the number of ulcers at Day 85, with treatment group, gender, and interaction of treatment group and gender as factors and the baseline ulcer number as a covariate.|||-54.82|-125.32|<0.0001
72580312|NCT00866359|144690109|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.7||||0.0007|TWO_SIDED|95.0|-2.7|-0.8|||ANCOVA||Based on an analysis of covariance model for the number of ulcers at Day 85, with treatment group, gender, and interaction of treatment group and gender as factors and the baseline ulcer number as a covariate.|||-0.8|-2.7|0.0007
72545851|NCT02247479|144621361|SUPERIORITY||Difference in Adjusted Means|-1.6||||0.2515|TWO_SIDED|95.0|-4.33|1.13|||MMRM|||Week 48: MMRM analysis uses change as response variable and included treatment group, baseline score, baseline BCVA of better seeing eye, biomarker status, and sex.||1.13|-4.33|0.2515
72545852|NCT02247479|144621362|SUPERIORITY||Difference in Adjusted Means|-0.07||||0.2075|TWO_SIDED|95.0|-0.18|0.04|||MMRM|||Week 48: MMRM analysis uses change as response variable and included treatment group, baseline Mean FRI Index score, baseline BCVA of better seeing eye, biomarker status, and sex.||0.04|-0.18|0.2075
72545853|NCT02247479|144621362|SUPERIORITY||Difference in Adjusted Means|-0.08||||0.1222|TWO_SIDED|95.0|-0.19|0.02|||MMRM|||Week 48: MMRM analysis uses change as response variable and included treatment group, baseline Mean FRI Index score, baseline BCVA of better seeing eye, biomarker status, and sex.||0.02|-0.19|0.1222
72545854|NCT02247479|144621363|SUPERIORITY||Difference in Adjusted Means|-0.022||||0.8612|TWO_SIDED|95.0|-0.266|0.223|||MMRM|||CFI Positive: MMRM analysis uses change as response variable and included treatment group, visit, treatment-by-visit interaction, baseline GA area, lesion location, contiguity, biomarker status, modified baseline BCVA and sex.||0.223|-0.266|0.8612
72545855|NCT02247479|144621363|SUPERIORITY||Difference in Adjusted Means|0.077||||0.5317|TWO_SIDED|95.0|-0.165|0.319|||MMRM|||CFI Positive: MMRM analysis uses change as response variable and included treatment group, visit, treatment-by-visit interaction, baseline GA area, lesion location, contiguity, biomarker status, modified baseline BCVA and sex.||0.319|-0.165|0.5317
72411856|NCT00406029|144331717|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.4||||0.861|TWO_SIDED|95.0|-4.5|3.8|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.||3.8|-4.5|0.861
72580313|NCT00866359|144690110|SUPERIORITY_OR_OTHER_LEGACY||adjusted difference (percentage)|39.1|||<|0.0001|TWO_SIDED|95.0|23.6|54.5|||Cochran-Mantel-Haenszel|Two-sided p-value was based on the CMH test adjusting for gender.|Adjusted difference in proportions = weighted average of treatment differences across gender with the CMH weights.|||54.5|23.6|<0.0001
72580314|NCT00866359|144690111|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.1||||0.0007|TWO_SIDED|95.0|-1.7|-0.5|||ANCOVA||Based on an Ancova model for change from baseline with treatment group, gender and interaction of treatment group and gender as factors and the baseline value as a covariate.|||-0.5|-1.7|0.0007
72580315|NCT01625091|144690135|SUPERIORITY|||||||0.36|||||||Chi-squared|||||||0.36
72580316|NCT01625091|144690136|SUPERIORITY|||||||0.36|||||||Wilcoxon (Mann-Whitney)|||||||0.36
72580317|NCT01625091|144690137|SUPERIORITY|||||||0.7|||||||t-test, 2 sided|||||||0.70
72580318|NCT01625091|144690138|SUPERIORITY|||||||0.98|||||||t-test, 2 sided|||||||0.98
72580319|NCT03051672|144690144|SUPERIORITY|||||||||||||The study terminated at stage 1 and no p-value was estimated.||||The study uses a Simon 2-stage design. In stage 1, if \>/=1 of 8 achieved OR then continue to stage 2 (enroll 19 more). If \>/= 3 of 27 respond, the regimen would be considered promising. The null ORR\<= 3% and alternative ORR\>/=20%. With this design, the probability of stopping the trial early is 58% if the true ORR is 3%. This design at 80% power to declare the combination effective, while controlling for less than 5% 1-sided type I error under the null hypothesis.|The study terminated at stage 1 and no p-value was estimated.|||
72545856|NCT02247479|144621363|SUPERIORITY||Difference in Adjusted Means|-0.033||||0.824|TWO_SIDED|95.0|-0.322|0.257|||MMRM|||CFI Negative: MMRM analysis uses change as response variable and included treatment group, visit, treatment-by-visit interaction, baseline GA area, lesion location, contiguity, biomarker status, modified baseline BCVA and sex.||0.257|-0.322|0.8240
72545857|NCT02247479|144621363|SUPERIORITY||Difference in Adjusted Means|0.006||||0.9676|TWO_SIDED|95.0|-0.283|0.294|||MMRM|||CFI Negative: MMRM analysis uses change as response variable and included treatment group, visit, treatment-by-visit interaction, baseline GA area, lesion location, contiguity, biomarker status, modified baseline BCVA and sex.||0.294|-0.283|0.9676
72545858|NCT01073020|144621364|SUPERIORITY||proportion|0.08||||0.6|TWO_SIDED||||||Chi-squared||Estimation parameter is the difference between the proportion of patients in the LAGB group vs. proportion of patients in the Intensive Medical Diabetes \& Weight Management (LAGB Grp) who achieved the primary outcome.|||||0.60
72545859|NCT01073020|144621364|SUPERIORITY||proportion|0.42||||0.005|TWO_SIDED||||||Chi-squared||Estimation parameter is the difference between the proportion of patients in the RYGB group vs. proportion of patients in the Intensive Medical Diabetes \& Weight Management (RYGB Grp) who achieved the primary outcome.|||||0.005
72545860|NCT01073020|144621365|SUPERIORITY||Mean Difference (Net)|1.0||||0.33|TWO_SIDED|95.0|||||Mixed Models Analysis||Estimation parameter is the difference between the change from baseline in HbA1c in the LAGB group vs. change from baseline in HbA1c in the Intensive Medical Diabetes \& Weight Management (LAGB Grp), adjusted for baseline HbA1c.|||||0.33
72545861|NCT01073020|144621365|SUPERIORITY||Mean Difference (Net)|1.4|||<|0.001|TWO_SIDED|95.0|||||Mixed Models Analysis||Estimation parameter is the difference between the change from baseline in HbA1c in the RYGB group vs. change from baseline in HbA1c in the Intensive Medical Diabetes \& Weight Management (RYGB Grp), adjusted for baseline HbA1c.|||||<0.001
72545862|NCT01073020|144621366|SUPERIORITY||Mean Difference (Net)|2.2|||<|0.001|TWO_SIDED|95.0|||||Mixed Models Analysis||Estimation parameter is the difference between the change from baseline in BMI in the LAGB group vs. change from baseline in BMI in the Intensive Medical Diabetes \& Weight Management (LAGB Grp), adjusted for baseline BMI.|||||<0.001
72545863|NCT01073020|144621366|SUPERIORITY||Mean Difference (Net)|4.6|||<|0.001|TWO_SIDED|95.0|||||Mixed Models Analysis||Estimation parameter is the difference between the change from baseline in BMI in the RYGB group vs. change from baseline in BMI in the Intensive Medical Diabetes \& Weight Management (RYGB Grp), adjusted for baseline BMI.|||||<0.001
72411857|NCT00406029|144331717|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.0||||0.621|TWO_SIDED|95.0|-5.2|3.1|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.||3.1|-5.2|0.621
72411858|NCT00406029|144331717|SUPERIORITY_OR_OTHER||Difference in LS Means|-2.2||||0.288|TWO_SIDED|95.0|-6.4|1.9|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.9|-6.4|0.288
72545864|NCT01073020|144621367|SUPERIORITY||Mean Difference (Net)|1.5||||0.81|TWO_SIDED|95.0|||||Mixed Models Analysis||Estimation parameter is the difference between change from baseline in CHD risk over 10 yrs. in LAGB group vs. change from baseline in CHD risk over 10 yrs. in Intensive Medical Diabetes \& Weight Management (LAGB Grp), adjusted for baseline CHD risk.|||||0.81
72545865|NCT01073020|144621367|SUPERIORITY||Mean Difference (Net)|2.6||||0.009|TWO_SIDED|95.0|||||Mixed Models Analysis||Estimation parameter is the difference between change from baseline in CHD risk over 10 yrs. in RYGB group vs. change from baseline in CHD risk over 10 yrs. in Intensive Medical Diabetes \& Weight Management (RYGB Grp), adjusted for baseline CHD risk.|||||0.009
72545866|NCT01590433|144621399|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
72545867|NCT00992264|144621409|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.88|||||TWO_SIDED|95.0|0.51|1.51|||||OR for smoking abstinence at 12 months in intent to treat sample. Participants receiving content written in a Prescriptive tone were compared against persons receiving content in a Motivational tone (ref group).|Comparison of persons assigned to Prescriptive message tone (n = 932) against persons assigned to Motivational message tone (n = 933).||1.51|0.51|
72580320|NCT01459783|144690151|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.91||||0.76|TWO_SIDED|95.0|-5.13|6.95||We adopted Bonferroni adjustment for multiple testing and used a significance level of .05/3 = 0.017 to interpret the results for our primary outcomes.|Regression, Linear|Multivariate analyses included non-response weights and controlled for study arm, stratification variables, baseline values, \& intervention duration.|The difference in differences at 12 months is reported as in-person arm minus phone arm values from a multivariable analysis. A positive adjusted difference means worse burden for the in-person arm compared to the phone arm.|Analyses were intention-to-treat. Due to attrition and those ineligible for 12-month follow-up due to study ending before that time, we created survey non-response weights for each wave. Prior to the study, a sample size of 125 participants per group was based on the two primary outcomes, with a Type I Error of 0.025 (Bonferroni adjustment), setting a 0.5-SD difference in outcomes as clinically important, 80% power, 0.45 SD difference in difference in outcomes between groups, and 25% attrition.||6.95|-5.13|0.76
72545868|NCT00992264|144621409|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.12|||||TWO_SIDED|95.0|0.66|1.91|||||OR for smoking abstinence at 12 months when persons who randomly received a Testimonial were compared against persons receiving No Testimonial (ref group).|Comparison of persons assigned to Testimonials (n = 933) against persons assigned to receive no testimonials (n = 932).||1.91|0.66|
72545869|NCT00992264|144621409|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.19|||||TWO_SIDED|95.0|0.7|2.02|||||OR for smoking abstinence at 12 months when persons assigned to Dictated navigation were compared to those not assigned to Dictated navigation (ref group).|Comparison of persons assigned to the Dictated Navigation arm (n = 934) against persons assigned to assigned free navigation of the website (n = 931).||2.02|0.70|
72411859|NCT00406029|144331717|SUPERIORITY_OR_OTHER||Difference in LS Means|0.3||||0.861|TWO_SIDED|95.0|-3.5|4.1|||ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.||4.1|-3.5|0.861
72411860|NCT00406029|144331717|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.1||||0.954|TWO_SIDED|95.0|-4.0|3.7|||ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.||3.7|-4.0|0.954
72411861|NCT00406029|144331717|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.6||||0.419|TWO_SIDED|95.0|-5.5|2.3|||ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.||2.3|-5.5|0.419
72411862|NCT00406029|144331717|SUPERIORITY_OR_OTHER||Difference in LS Means|-3.2||||0.088|TWO_SIDED|95.0|-6.9|0.5|||ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.5|-6.9|0.088
72411863|NCT00406029|144331718|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.2||||0.924|TWO_SIDED|95.0|-3.5|3.2|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.||3.2|-3.5|0.924
72411864|NCT00406029|144331718|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.4||||0.84|TWO_SIDED|95.0|-3.8|3.1|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.||3.1|-3.8|0.840
72411865|NCT00406029|144331718|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.9||||0.599|TWO_SIDED|95.0|-4.4|2.5|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.||2.5|-4.4|0.599
72411866|NCT00406029|144331718|SUPERIORITY_OR_OTHER||Difference in LS Means|-2.6||||0.134|TWO_SIDED|95.0|-6.0|0.8|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.8|-6.0|0.134
72411867|NCT00406029|144331718|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.4||||0.846|TWO_SIDED|94.0|-4.1|3.3|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.||3.3|-4.1|0.846
72411868|NCT00406029|144331718|SUPERIORITY_OR_OTHER||Difference in LS Means|1.3||||0.467|TWO_SIDED|95.0|-2.3|5.0|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.||5.0|-2.3|0.467
72411869|NCT00406029|144331718|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.2||||0.533|TWO_SIDED|95.0|-4.8|2.5|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.||2.5|-4.8|0.533
72411870|NCT00406029|144331718|SUPERIORITY_OR_OTHER||Difference in LS Means|-3.1||||0.094|TWO_SIDED|95.0|-6.7|0.5|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.5|-6.7|0.094
72411871|NCT00406029|144331718|SUPERIORITY_OR_OTHER||Difference in LS Means|0.0||||0.994|TWO_SIDED|95.0|-3.7|3.7|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.||3.7|-3.7|0.994
72411872|NCT00406029|144331718|SUPERIORITY_OR_OTHER||Difference in LS Means|0.1||||0.944|TWO_SIDED|95.0|-3.5|3.8|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.||3.8|-3.5|0.944
72411873|NCT00406029|144331718|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.5||||0.424|TWO_SIDED|95.0|-5.1|2.2|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.||2.2|-5.1|0.424
72411874|NCT00406029|144331718|SUPERIORITY_OR_OTHER||Difference in LS Means|-4.0||||0.042|TWO_SIDED|95.0|-7.8|-0.2|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.||-0.2|-7.8|0.042
72411875|NCT00406029|144331718|SUPERIORITY_OR_OTHER||Difference in LS Means|3.7||||0.075|TWO_SIDED|95.0|-0.4|7.8|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.||7.8|-0.4|0.075
72411876|NCT00406029|144331718|SUPERIORITY_OR_OTHER||Difference in LS Means|3.9||||0.052|TWO_SIDED|95.0|0.0|7.8|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.||7.8|0.0|0.052
72411877|NCT00406029|144331718|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.1||||0.975|TWO_SIDED|95.0|-4.0|3.9|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.||3.9|-4.0|0.975
72411878|NCT00406029|144331718|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.2||||0.541|TWO_SIDED|95.0|-5.2|2.8|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.||2.8|-5.2|0.541
72411879|NCT00406029|144331718|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.2||||0.931|TWO_SIDED|95.0|-4.1|3.7|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.||3.7|-4.1|0.931
72411880|NCT00406029|144331718|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.0||||0.618|TWO_SIDED|95.0|-4.7|2.8|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.||2.8|-4.7|0.618
72545870|NCT00992264|144621409|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.75|||||TWO_SIDED|95.0|0.43|1.3|||||OR for smoking abstinence at 12 months when persons assigned to receive Proactive Email reminders were compared against persons who received No Emails (ref group).|Comparison of persons assigned to Proactive Email Outreach (n = 933) against persons assigned to receive No Proactive Email Outreach (n = 932).||1.30|0.43|
72545871|NCT00992264|144621410|SUPERIORITY_OR_OTHER||Odds Ratio, log|0.94|||||TWO_SIDED|95.0|0.62|1.43|||||OR for use of adjunct treatment at 12 months when persons assigned to Prescriptive Tone were compared to persons assigned to receive content in a Motivational Tone (ref group).|Comparison of persons assigned to Prescriptive message tone (n = 932) against persons assigned to Motivational message tone (n = 933).||1.43|0.62|
72545872|NCT00992264|144621410|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.7|||||TWO_SIDED|95.0|0.46|1.07|||||OR for use of adjunct treatment at 12 months when persons assigned to receive a Testimonial were compared to persons assigned to receive No Testimonial (ref group).|Comparison of persons assigned to Testimonials (n = 933) against persons assigned to receive no testimonials (n = 932).||1.07|0.46|
72545873|NCT00992264|144621410|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.78|||||TWO_SIDED|95.0|0.51|1.18|||||OR for use of adjunct treatment at 12 months when persons assigned to Dictated Navigation were compared to persons not assigned to Dictated Navigation (ref group).|Comparison of persons assigned to the Dictated Navigation arm (n = 934) against persons assigned to assigned free navigation of the website (n = 931).||1.18|0.51|
72545874|NCT00992264|144621410|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.67|||||TWO_SIDED|95.0|0.44|1.03|||||OR for use of adjunct treatment at 12 months when persons assigned to Proactive Email reminders were compared to persons not assigned to receive Proactive Email reminders (ref group).|Comparison of persons assigned to Proactive Email Outreach (n = 933) against persons assigned to receive No Proactive Email Outreach (n = 932).||1.03|0.44|
72545875|NCT00449072|144621430|SUPERIORITY_OR_OTHER||Difference (LS Mean)|-0.45||||0.0096|TWO_SIDED|95.0|-0.78|-0.11|||ANCOVA|The treatment arm, age group (at Visit 1) and sex were fixed effects, and baseline growth velocity was a covariate in the ANCOVA model||||-0.11|-0.78|0.0096
72545876|NCT00449072|144621431|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.12||||0.7341|TWO_SIDED|95.0|-0.83|0.58|||ANCOVA||The treatment arm, sex and age group were fixed effects, and baseline value was a covariate in the ANCOVA model.|||0.58|-0.83|0.7341
72411881|NCT00406029|144331718|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.8||||0.341|TWO_SIDED|95.0|-5.6|1.9|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.9|-5.6|0.341
72411882|NCT00406029|144331718|SUPERIORITY_OR_OTHER||Difference in LS Means|-2.2||||0.256|TWO_SIDED|95.0|-6.0|1.6|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.6|-6.0|0.256
72411883|NCT00406029|144331718|SUPERIORITY_OR_OTHER||Difference in LS Means|1.8||||0.399|TWO_SIDED|95.0|-2.4|6.0|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.||6.0|-2.4|0.399
72545877|NCT00449072|144621432|SUPERIORITY_OR_OTHER||LS Mean Differerence|-0.15||||0.1963|TWO_SIDED|95.0|-0.37|0.08|||ANCOVA||The treatment arm, sex and age group were fixed effects, and baseline value was a covariate in the ANCOVA model.|Change in nasal stuffiness||0.08|-0.37|0.1963
72545878|NCT00449072|144621432|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.04||||0.7193|TWO_SIDED|95.0|-0.24|0.17|||ANCOVA||The treatment arm, sex and age group were fixed effects, and baseline value was a covariate in the ANCOVA model.|Change in Nasal Discharge||0.17|-0.24|0.7193
72545879|NCT00449072|144621432|SUPERIORITY_OR_OTHER||LS Mean Difference|0.09||||0.402|TWO_SIDED|95.0|-0.12|0.29|||ANCOVA||The treatment arm, sex and age group were fixed effects, and baseline value was a covariate in the ANCOVA model.|Change in Sneezing||0.29|-0.12|0.4020
72545880|NCT00449072|144621432|SUPERIORITY_OR_OTHER||LS mean Difference|-0.02||||0.8854|TWO_SIDED|95.0|-0.23|0.2|||ANCOVA||The treatment arm, sex and age group were fixed effects, and baseline value was a covariate in the ANCOVA model.|Change in Nasal Itching||0.20|-0.23|0.8854
72545881|NCT00449072|144621433|SUPERIORITY_OR_OTHER|||||||0.0951||95.0|||||Mixed model for repeated measures|The treatment arm, assessment visit, their interaction, sex and age group were fixed effects, and assessment visit was a repeated factor.||Statistical Analysis for Day 120||||0.0951
72545882|NCT00449072|144621433|SUPERIORITY_OR_OTHER|||||||0.1247||95.0|||||Mixed model for repeated measures|The treatment arm, assessment visit, their interaction, sex and age group were fixed effects, and assessment visit was a repeated factor.||Statistical analysis for Day 240||||0.1247
72545883|NCT00449072|144621433|SUPERIORITY_OR_OTHER|||||||0.0207||95.0|||||Mixed model for repeated measures|The treatment arm, assessment visit, their interaction, sex and age group were fixed effects, and assessment visit was a repeated factor.||Statistical analysis for Day 360||||0.0207
72545884|NCT00449072|144621434|SUPERIORITY_OR_OTHER|||||||0.2445||95.0|||||Mixed model for repeated measures|The treatment arm, assessment visit, their interaction, sex and age group were fixed effects, and assessment visit was a repeated factor.||Statistical Analysis for Day 120||||0.2445
72545885|NCT00449072|144621434|SUPERIORITY_OR_OTHER|||||||0.4488||95.0|||||Mixed model for repeated measures|The treatment arm, assessment visit, their interaction, sex and age group were fixed effects, and assessment visit was a repeated factor.||Statistical Analysis for Day 240||||0.4488
72411884|NCT00406029|144331718|SUPERIORITY_OR_OTHER||Difference in LS Means|1.4||||0.477|TWO_SIDED|95.0|-2.5|5.4|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.||5.4|-2.5|0.477
72411885|NCT00406029|144331718|SUPERIORITY_OR_OTHER||Difference in LS Means|-2.8||||0.172|TWO_SIDED|95.0|-6.8|1.2|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.2|-6.8|0.172
72411886|NCT00406029|144331718|SUPERIORITY_OR_OTHER||Difference in LS Means|-2.3||||0.254|TWO_SIDED|95.0|-6.2|1.7|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.7|-6.2|0.254
72411887|NCT00406029|144331718|SUPERIORITY_OR_OTHER||Difference in LS Means|0.1||||0.972|TWO_SIDED|95.0|-3.6|3.8|||ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.||3.8|-3.6|0.972
72545886|NCT00449072|144621434|SUPERIORITY_OR_OTHER|||||||0.0142||95.0||||The treatment arm, assessment visit, their interaction, sex and age group were fixed effects, and assessment visit was a repeated factor.|Mixed model for repeated measures|||Statistical Analysis for Day 360||||0.0142
72545887|NCT01787825|144621440|NON_INFERIORITY|This is McNemar design.|percentage concordance|77.19||||1|TWO_SIDED|95.0|68.68|83.93||The blinded readers assessed concordance of normal versus abnormal and overall concordance of clinically significant abnormal images.|McNemar||Overall concordance of clinically significant abnormal images.|There was a comparison between normal and abnormal images. And detailed analysis of abnormal images that were considered clinical significant.||83.93|68.68|1.0000
72545888|NCT01787825|144621442|SUPERIORITY_OR_OTHER||percentage concordance|71.93||||0.972|TWO_SIDED|95.0|63.07|79.36|||Bowkers|||||79.36|63.07|0.972
72545889|NCT01602614|144621501|OTHER|Spearman Rank Correlation||||||0.3117|||||||Spearman Rank Correlation|||No subjects were enrolled in Group 1 and Group 4. One subject in Group 3 did not collect full PK panel therefore no pk was analyzed for this subject.||||0.3117
72545890|NCT01602614|144621502|OTHER|Spearman Rank Correlation||||||0.6175||||||Spearman Rank Correlation|Spearman Rank Correlation|||No subjects were enrolled in Group 1 and Group 4. One subject in Group 3 did not collect full PK panel therefore no pk was analyzed for this subject.||||0.6175
72545891|NCT01602614|144621503|OTHER|Spearman Rank Correlation||||||0.7129||||||Spearman Rank Correlation|Spearman Rank Correlation|||No subjects were enrolled in Group 1 and Group 4. One subject in Group 3 did not collect full PK panel therefore no pk was analyzed for this subject.||||0.7129
72545892|NCT01602614|144621504|OTHER|Spearman Rank Correlation||||||0.9828|||||||Spearman Rank Correlation|||No subjects were enrolled in Group 1 and Group 4. One subject in Group 3 did not collect full PK panel therefore no pk was analyzed for this subject.||||0.9828
72545893|NCT01602614|144621505|OTHER|Spearman Rank Correlation||||||0.9656|||||||Spearman Rank Correlation|||No subjects were enrolled in Group 1 and Group 4. One subject in Group 3 did not collect full PK panel therefore no pk was analyzed for this subject.||||0.9656
72545894|NCT01602614|144621506|OTHER|Spearman Rank Correlation||||||0.5113|||||||Spearman Rank Correlation|||No subjects were enrolled in Group 1 and Group 4. One subject in Group 3 did not collect full PK panel therefore no pk was analyzed for this subject.||||0.5113
72545895|NCT01602614|144621507|OTHER|Spearman Rank Correlation||||||0.217||||||Spearman Rank Correlation|Spearman Rank Correlation|||No subjects were enrolled in Group 1 and Group 4. One subject in Group 3 did not collect full PK panel therefore no pk was analyzed for this subject.||||0.2170
72545896|NCT01602614|144621508|OTHER|Spearman Rank Correlation||||||0.4299||||||Spearman Rank Correlation|Spearman Rank Correlation|||No subjects were enrolled in Group 1 and Group 4. One subject in Group 3 did not collect full PK panel therefore no pk was analyzed for this subject.||||0.4299
72545897|NCT01602614|144621509|OTHER|Spearman Rank Correlation||||||0.8629||||||Spearman Rank Correlation|Spearman Rank Correlation|||No subjects were enrolled in Group 1 and Group 4. One subject in Group 3 did not collect full PK panel therefore no pk was analyzed for this subject.||||0.8629
72545898|NCT01602614|144621510|OTHER|Spearman Rank Correlation||||||0.5717||||||Spearman Rank Correlation|Spearman Rank Correlation|||No subjects were enrolled in Group 1 and Group 4. One subject in Group 3 did not collect full PK panel therefore no pk was analyzed for this subject.||||0.5717
72545899|NCT01798485|144621522|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.111||||0.3293|TWO_SIDED|95.0|0.899|1.372|||Log Rank|P-value was from stratified log-rank test (strata: screening LDH, screening ECOG and geographic region).||Primary study hypothesis was tested at a 2-sided, 0.05 significance level using a stratified log-rank test.||1.372|0.899|0.3293
72552614|NCT02728102|144636043|SUPERIORITY|||||||0.4417||||||Statistical significance was determined using a pre-specified threshold of 0.05|Chi-squared|||Proportion of participants achieving CR among the subset of participants who are not in CR at the time of randomization between the vaccine and the combined non-vaccine arms at 12 months Post Transplant.||||0.4417
72545900|NCT01798485|144621522|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.111|||||TWO_SIDED|99.5|0.821|1.503||||||"Futility analysis for the first Interim Analysis which had a database cutoff of 19 October 2015. For the first interim analysis, if the lower limit of the 2-sided 99.5% confidence interval (CI) for the Hazard Ratio was greater than 0.75, then the study could be stopped for futility, based on Data Monitoring Committee recommendation.~Hazard ratio and 99.5% CI were calculated using the stratified Cox Proportional Hazards model (strata: screening LDH, screening ECOG and geographic region)."||1.503|0.821|
72411888|NCT00406029|144331718|SUPERIORITY_OR_OTHER||Difference in LS Means|0.3||||0.891|TWO_SIDED|95.0|-3.5|4.0|||ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.||4.0|-3.5|0.891
72545901|NCT01798485|144621523|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.161||||0.118|TWO_SIDED|95.0|0.961|1.403||Significance level of 0.05.|Log Rank|Stratified log-rank test with stratification variables, ECOG, screening total LDH levels, and geographic region, used to compare the treatment groups.||||1.403|0.961|0.1180
72545902|NCT01798485|144621524|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.232||||0.2506|TWO_SIDED|95.0|0.865|1.754||Significance level of 0.05.|Log Rank|P-value was from stratified log-rank test (strata: screening ECOG and geographic region).||||1.754|0.865|0.2506
72545903|NCT01798485|144621525|SUPERIORITY_OR_OTHER|||||||0.448|TWO_SIDED|||||Significance level of 0.05.|Fisher Exact|||||||0.448
72545904|NCT01798485|144621526|SUPERIORITY_OR_OTHER|||||||0.339|TWO_SIDED|||||Significance level of 0.05.|Fisher Exact|||\>= 6 weeks||||0.339
72545905|NCT01798485|144621526|SUPERIORITY_OR_OTHER|||||||0.817|TWO_SIDED|||||Significance level of 0.05.|Fisher Exact|||\>= 12 weeks||||0.817
72545906|NCT01798485|144621527|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.344||||0.0111|TWO_SIDED|95.0|1.207|4.551||Significance level of 0.05.|Log Rank|P-value was from stratified log-rank test (strata: screening LDH, screening ECOG and geographic region).||||4.551|1.207|0.0111
72545907|NCT01798485|144621528|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.112||||0.5191|TWO_SIDED|95.0|0.797|1.551||Significance level of 0.05.|Log Rank|P-value was from stratified log-rank test (strata: screening ECOG and geographic region).||||1.551|0.797|0.5191
72545908|NCT01798485|144621531|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.233||||0.1343|TWO_SIDED|95.0|0.937|1.621||Significance level of 0.05.|Log Rank|Stratified log-rank test (strata: screening LDH, screening ECOG and geographic region).||||1.621|0.937|0.1343
72580321|NCT01459783|144690152|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.9||||0.49|TWO_SIDED|95.0|-1.74|3.55||We used Bonferroni adjustment for multiple testing and a significance level of .05/3 = 0.017 to interpret the results for our primary outcomes. The behavior measure is analyzed two ways: total number of problems (reported here), and reaction score.|Regression, Linear|Multivariate analyses included non-response weights and controlled for study arm, stratification variables, baseline values, \& intervention duration.|The difference in differences at 12 months is reported as in-person arm minus phone arm values from a multivariable analysis. A positive adjusted difference means worse problems for the in-person arm compared to the phone arm.|Analyses were intention-to-treat. Due to attrition and those ineligible for 12-month follow-up due to study ending before that time, we created survey non-response weights for each wave. Prior to the study, a sample size of 125 participants per group was based on the two primary outcomes, with a Type I Error of 0.025 (Bonferroni adjustment), setting a 0.5-SD difference in outcomes as clinically important, 80% power, 0.45 SD difference in difference in outcomes between groups, and 25% attrition.||3.55|-1.74|0.49
72580322|NCT05351164|144690159|SUPERIORITY|||||||0.004|||||||t-test, 2 sided|||||||0.004
72580323|NCT05351164|144690160|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
72580324|NCT03493685|144690161|OTHER||Slope difference|0.3|STANDARD_ERROR_OF_MEAN|1.05||0.7491|TWO_SIDED|95.0|-1.74|2.41|||Mixed Models Analysis|||||2.41|-1.74|0.7491
72580325|NCT03493685|144690162|OTHER||Risk Difference (RD)|16.0||||0.0094|TWO_SIDED|95.0|3.96|28.04|||Mixed Models Analysis|||||28.04|3.96|0.0094
72580326|NCT03493685|144690163|OTHER||Slope difference|0.9|STANDARD_ERROR_OF_MEAN|1.09||0.4203|TWO_SIDED|95.0|-1.27|3.04|||Mixed Models Analysis|||||3.04|-1.27|0.4203
72580327|NCT03493685|144690164|OTHER||Mean Difference (Final Values)|1.8||||0.2708|TWO_SIDED|95.0|-1.39|4.93|||ANCOVA|||||4.93|-1.39|0.2708
72545909|NCT01798485|144621532|SUPERIORITY_OR_OTHER|||||||0.25|TWO_SIDED|||||Significance level of 0.05.|Fisher Exact|||||||0.250
72545910|NCT01333033|144621579|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.0
72545911|NCT00543439|144621632|SUPERIORITY||Ratio of arithmetic means|0.03||||0.002|ONE_SIDED|95.0||0.08|||Paired t-test|||Ratio of the arithmetic means of the ABR for OD cohort: OD therapy to OD cohort: RP therapy 25 IU/kg was calculated. One-sided 95% CI for this ratio was reported.||0.08||0.0020
72580328|NCT03300817|144690170|SUPERIORITY|||||||0.6834|||||||Wilcoxon Rank-Sum test|||||||0.6834
72580329|NCT03713593|144690201|OTHER|Descriptive assessment|Hazard Ratio (HR)|0.834|||||TWO_SIDED|95.0|0.712|0.978|||||Based on Cox model with Efron's method of tie handling with treatment as a covariate stratified by geographic region, MPVI or extrahepatic spread or both, AFP and ECOG PS.|||0.978|0.712|
72580330|NCT03713593|144690202|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.0227|TWO_SIDED|95.0|0.708|0.997|||Log Rank|Onesided p-value based on logrank test stratified by geographic region, portal vein invasion/extrahepatic spread/both AFP status,ECOG status.|Based on Cox model with Efron's method of tie handling with treatment as a covariate stratified by geographic region, MPVI or extrahepatic spread or both, AFP and ECOG PS.|||0.997|0.708|0.0227
72580331|NCT03713593|144690203|OTHER|Descriptive assessment|Difference in percentage|8.5|||||TWO_SIDED|95.0|2.8|14.2|||||Based on Miettinen \& Nurminen method stratified by geographic region, MPVI or extrahepatic spread or both, AFP and ECOG PS.|||14.2|2.8|
72580332|NCT03713593|144690206|OTHER|Descriptive assessment|Hazard Ratio (HR)|0.79|||||TWO_SIDED|95.0|0.66|0.93|||||Based on Cox model with Efron's method of tie handling with treatment as a covariate stratified by geographic region, MPVI or extrahepatic spread or both, AFP and ECOG PS.|||0.93|0.66|
72580333|NCT03713593|144690207|OTHER|Descriptive assessment|Hazard Ratio (HR)|0.8|||||TWO_SIDED|95.0|0.68|0.94|||||Based on Cox model with Efron's method of tie handling with treatment as a covariate stratified by geographic region, MPVI or extrahepatic spread or both, AFP and ECOG PS.|||0.94|0.68|
72411889|NCT00406029|144331718|SUPERIORITY_OR_OTHER||Difference in LS Means|-2.8||||0.143|TWO_SIDED|95.0|-6.6|1.0|||ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.0|-6.6|0.143
72545912|NCT00543439|144621633|EQUIVALENCE|90% 2-sided CI for the mean difference in ABRs for the 2 prophylaxis regimens for ITT participants was constructed using the t distribution with n-1 degrees of freedom (n equals the number of participants) to assess the equivalence of the 2 regimens. Equivalence was demonstrated and the null hypothesis rejected if the limits of the 90% CI fell wholly within the interval of (-4, 4) bleeds per year.|Mean Difference (Final Values)|1.1|||||TWO_SIDED|90.0|0.03|2.22||||||||2.22|0.03|
72545913|NCT00319956|144621671|SUPERIORITY|||||||0.2|||||||Chi-squared|||||||0.20
72545914|NCT02607800|144621684|NON_INFERIORITY|Noninferiority was demonstrated if the lower bound of the 2-sided 95% confidence interval (CI) for the difference in SVR12 was greater than -5%. If the lower bound of the CI was greater than -5% (ie, the noninferiority null hypothesis was rejected), a 2-sided stratified Cochran-Mantel-Haenszel test was to be used to test for the superiority of SOF/VEL/VOX for 8 weeks over SOF/VEL for 12 weeks at a significance level of 0.05.|Difference in proportions|-3.2|||||TWO_SIDED|95.0|-6.0|-0.4|||||Difference in proportions between treatment groups and associated 95% CI were calculated based on stratum-adjusted Mantel-Haenszel proportions.|||-0.4|-6.0|
72545915|NCT01202747|144621702|SUPERIORITY_OR_OTHER|||||||0.0005||||||p\<0.05 considered statistically significant|Regression, Linear|||||||0.0005
72545916|NCT01533428|144621734|SUPERIORITY_OR_OTHER||LS Mean Difference|-6.6||||0.025|TWO_SIDED|95.0|-12.3|-0.8|||ANCOVA|Analysis of covariance model including treatment, gender, pain score at baseline, HbA1c at screening and site as factors/covariates.||All statistical comparisons were made using two-sided tests at the 5% significance level||-0.8|-12.3|0.025
72545917|NCT01533428|144621735|SUPERIORITY_OR_OTHER||LS Mean Difference|-7.1||||0.018|TWO_SIDED|95.0|-12.9|-1.2|||ANCOVA|Analysis of covariance model including treatment, gender, pain score at baseline, HbA1c at screening and site as factors/covariates.||All statistical comparisons were made using two-sided tests at the 5% significance level.||-1.2|-12.9|0.018
72545918|NCT01533428|144621736|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.1||||0.208|TWO_SIDED|95.0|-10.4|2.3|||ANCOVA|Analysis of covariance model including treatment, gender, pain score at baseline, HbA1c at screening and site as factors/covariates.||Comparison of capsaicin 8% and placebo for change from Baseline to Week 2.||2.3|-10.4|0.208
72411890|NCT00406029|144331718|SUPERIORITY_OR_OTHER||Difference in LS Means|-3.2||||0.083|TWO_SIDED|95.0|-6.8|0.4|||ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.4|-6.8|0.083
72545919|NCT01533428|144621736|SUPERIORITY_OR_OTHER||LS Mean Difference|-6.7||||0.036|TWO_SIDED|95.0|-13.1|-0.4|||ANCOVA|Analysis of covariance model including treatment, gender, pain score at baseline, HbA1c at screening and site as factors/covariates.||Comparison of capsaicin 8% and placebo for change from Baseline to Week 3.||-0.4|-13.1|0.036
72545920|NCT01533428|144621736|SUPERIORITY_OR_OTHER||LS Mean Difference|-7.2||||0.027|TWO_SIDED|95.0|-13.5|-0.8|||ANCOVA|Analysis of covariance model including treatment, gender, pain score at baseline, HbA1c at screening and site as factors/covariates.||Comparison of capsaicin 8% and placebo for change from Baseline to Week 4.||-0.8|-13.5|0.027
72545921|NCT01533428|144621736|SUPERIORITY_OR_OTHER||LS Mean Difference|-7.3||||0.024|TWO_SIDED|95.0|-13.6|-1.0|||ANCOVA|Analysis of covariance model including treatment, gender, pain score at baseline, HbA1c at screening and site as factors/covariates.||Comparison of capsaicin 8% and placebo for change from Baseline to Week 5.||-1.0|-13.6|0.024
72545922|NCT01533428|144621736|SUPERIORITY_OR_OTHER||LS Mean Difference|-6.3||||0.051|TWO_SIDED|95.0|-12.6|0.0|||ANCOVA|Analysis of covariance model including treatment, gender, pain score at baseline, HbA1c at screening and site as factors/covariates.||Comparison of capsaicin 8% and placebo for change from Baseline to Week 6.||0.0|-12.6|0.051
72545923|NCT01533428|144621736|SUPERIORITY_OR_OTHER||LS Mean Difference|-8.1||||0.012|TWO_SIDED|95.0|-14.4|-1.8|||ANCOVA|Analysis of covariance model including treatment, gender, pain score at baseline, HbA1c at screening and site as factors/covariates.||Comparison of capsaicin 8% and placebo for change from Baseline to Week 7.||-1.8|-14.4|0.012
72545924|NCT01533428|144621736|SUPERIORITY_OR_OTHER||LS Mean Difference|-7.2||||0.026|TWO_SIDED|95.0|-13.5|-0.8|||ANCOVA|Analysis of covariance model including treatment, gender, pain score at baseline, HbA1c at screening and site as factors/covariates.||Comparison of capsaicin 8% and placebo for change from Baseline to Week 8.||-0.8|-13.5|0.026
72545925|NCT01533428|144621736|SUPERIORITY_OR_OTHER||LS Mean Difference|-6.9||||0.032|TWO_SIDED|95.0|-13.2|-0.6|||ANCOVA|Analysis of covariance model including treatment, gender, pain score at baseline, HbA1c at screening and site as factors/covariates.||Comparison of capsaicin 8% and placebo for change from Baseline to Week 9.||-0.6|-13.2|0.032
72580334|NCT03713593|144690208|OTHER|Descriptive assessment|Difference in percentage|6.7|||||TWO_SIDED|95.0|0.0|13.4|||||Based on Miettinen \& Nurminen method stratified by geographic region, MPVI or extrahepatic spread or both, AFP and ECOG PS.|||13.4|0.0|
72545926|NCT01533428|144621736|SUPERIORITY_OR_OTHER||LS Mean Difference|-7.5||||0.02|TWO_SIDED|95.0|-13.9|-1.2|||ANCOVA|Analysis of covariance model including treatment, gender, pain score at baseline, HbA1c at screening and site as factors/covariates.||Comparison of capsaicin 8% and placebo for change from Baseline to Week 10.||-1.2|-13.9|0.020
72411891|NCT00406029|144331719|SUPERIORITY_OR_OTHER||Difference in LS Means|0.5||||0.154|TWO_SIDED|95.0|-0.2|1.2|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.2|-0.2|0.154
72545927|NCT01533428|144621736|SUPERIORITY_OR_OTHER||LS Mean Difference|-7.4||||0.022|TWO_SIDED|95.0|-13.7|-1.1|||ANCOVA|Analysis of covariance model including treatment, gender, pain score at baseline, HbA1c at screening and site as factors/covariates.||Comparison of capsaicin 8% and placebo for change from Baseline to Week 11.||-1.1|-13.7|0.022
72545928|NCT01533428|144621736|SUPERIORITY_OR_OTHER||LS Mean Difference|-9.0||||0.005|TWO_SIDED|95.0|-15.3|-2.7|||ANCOVA|Analysis of covariance model including treatment, gender, pain score at baseline, HbA1c at screening and site as factors/covariates.||Comparison of capsaicin 8% and placebo for change from Baseline to Week 12.||-2.7|-15.3|0.005
72580335|NCT03713593|144690211|OTHER|Descriptive assessment|Hazard Ratio (HR)|0.73|||||TWO_SIDED|95.0|0.61|0.88|||||Based on Cox model with Efron's method of tie handling with treatment as a covariate stratified by geographic region, MPVI or extrahepatic spread or both, AFP and ECOG PS.|||0.88|0.61|
72545929|NCT01533428|144621738|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.4||||0.108|TWO_SIDED|95.0|0.9|2.2|||Regression, Logistic|Analysis of regression logistics model including treatment, gender, pain score at baseline, HbA1c at screening and site as factors/covariates.||Percentage of participants with 30% reduction in average daily pain score assessed in Weeks 2-8. The comparison of the odds ratio of capsaicin 8% to placebo for percent change from baseline was performed using a logistic regression model.||2.2|0.9|0.108
72411892|NCT00406029|144331719|SUPERIORITY_OR_OTHER||Difference in LS Means|0.3||||0.38|TWO_SIDED|95.0|-0.4|1.0|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.0|-0.4|0.380
72545930|NCT01533428|144621738|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.5||||0.05|TWO_SIDED|95.0|1.0|2.4|||Regression, Logistic|Analysis of regression logistics model including treatment, gender, pain score at baseline, HbA1c at screening and site as factors/covariates.||Percentage of participants with 30% reduction in average daily pain score assessed in Weeks 2-12. The comparison of the odds ratio of capsaicin 8% to placebo for percent change from baseline was performed using a logistic regression model.||2.4|1.0|0.050
72545931|NCT01533428|144621739|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.2||||0.403|TWO_SIDED|95.0|0.7|2.1|||Regression, Logistic|Analysis of regression logistics model including treatment, gender, pain score at baseline, HbA1c at screening and site as factors/covariates.||Percentage of participants with 50% reduction in average daily pain score assessed in Weeks 2-8. The comparison of the odds ratio of capsaicin 8% to placebo for percent change from baseline was performed using a logistic regression model.||2.1|0.7|0.403
72545932|NCT01533428|144621739|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.2||||0.446|TWO_SIDED|95.0|0.7|2.0|||Regression, Logistic|Analysis of regression logistics model including treatment, gender, pain score at baseline, HbA1c at screening and site as factors/covariates.||Percentage of participants with 50% reduction in average daily pain score assessed in Weeks 2-12. The comparison of the odds ratio of capsaicin 8% to placebo for percent change from baseline was performed using a logistic regression model.||2.0|0.7|0.446
72545933|NCT01533428|144621740|SUPERIORITY_OR_OTHER|||||||0.072|TWO_SIDED||||||Cochran-Mantel-Haenszel|Analysis of Cochran-Mantel-Haenszel test model including treatment, gender, pain score at baseline, HbA1c at screening and site as factors/covariates.||Comparing the difference between capsaicin 8% and placebo for counts by category using a Cochran-Mantel-Haenszel test.||||0.072
72545934|NCT01533428|144621741|SUPERIORITY_OR_OTHER|||||||0.075|TWO_SIDED||||||Cochran-Mantel-Haenszel|Analysis of Cochran-Mantel-Haenszel test model including treatment, gender, pain score at baseline, HbA1c at screening and site as factors/covariates.||Comparing the difference between capsaicin 8% and placebo for counts by category using a Cochran-Mantel-Haenszel test.||||0.075
72580336|NCT04467840|144690217|SUPERIORITY||Risk Difference (RD)|3.86||||0.391|TWO_SIDED|95.0|-4.93|12.65||The threshold for statistical significance was p = 0.05|Cochran-Mantel-Haenszel||Opaganib - Placebo|||12.65|-4.93|0.391
72580337|NCT04467840|144690218|SUPERIORITY||Risk Difference (RD)|3.91||||0.38|TWO_SIDED|95.0|-4.78|12.6||The threshold for statistical significance was p = 0.05, only if the primary endpoint was significant. This p-value is not adjusted for multiple comparisons because the primary endpoint was not met.|Cochran-Mantel-Haenszel|||||12.60|-4.78|0.380
72580338|NCT04467840|144690219|SUPERIORITY||Hazard Ratio (HR)|1.15||||0.231|TWO_SIDED|95.0|0.91|1.45||The threshold for statistical significance was p = 0.05, only if the primary endpoint was significant. This p-value is not adjusted for multiple comparisons because the primary endpoint was not met.|Log Rank|||||1.45|0.91|0.231
72580339|NCT04467840|144690220|SUPERIORITY||Hazard Ratio, log|1.08||||0.472|TWO_SIDED|95.0|0.87|1.33||The threshold for statistical significance was p = 0.05, only if the primary endpoint was significant. This p-value is not adjusted for multiple comparisons because the primary endpoint was not met.|Log Rank|||||1.33|0.87|0.472
72580340|NCT04467840|144690221|SUPERIORITY||Hazard Ratio (HR)|1.08||||0.521|TWO_SIDED|95.0|0.846|1.378||The threshold for statistical significance was p = 0.05, only if the primary endpoint was significant. This p-value is not adjusted for multiple comparisons because the primary endpoint was not met.|Log Rank|||||1.378|0.846|0.521
72580341|NCT04467840|144690222|SUPERIORITY||Risk Difference (RD)|-1.51||||0.701|TWO_SIDED|95.0|-9.19|6.18||The threshold for statistical significance was p = 0.05, only if the primary endpoint was significant. This p-value is not adjusted for multiple comparisons because the primary endpoint was not met.|Cochran-Mantel-Haenszel|||||6.18|-9.19|0.701
72580342|NCT04467840|144690223|SUPERIORITY|The threshold for statistical significance was p = 0.05, only if the primary endpoint was significant. This p-value is not adjusted for multiple comparisons because the primary endpoint was not met.|Hazard Ratio (HR)|1.34||||0.043|TWO_SIDED|95.0|0.99|1.82|||Log Rank|||||1.82|0.99|0.043
72411893|NCT00406029|144331719|SUPERIORITY_OR_OTHER||Difference in LS Means|0.4||||0.288|TWO_SIDED|95.0|-0.3|1.1|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.1|-0.3|0.288
72580343|NCT04467840|144690224|SUPERIORITY|The threshold for statistical significance was p = 0.05, only if the primary endpoint was significant. This p-value is not adjusted for multiple comparisons because the primary endpoint was not met.|Risk Difference (RD)|8.3||||0.118|TWO_SIDED|95.0|-2.05|18.65|||Cochran-Mantel-Haenszel|||||18.65|-2.05|0.118
72580344|NCT04467840|144690228|SUPERIORITY||Risk Difference (RD)|12.28||||0.033|TWO_SIDED|95.0|1.06|23.5||unadjusted p-value|Cochran-Mantel-Haenszel|||||23.50|1.06|0.033
72580345|NCT04467840|144690229|SUPERIORITY||Risk Difference (RD)|-4.75||||0.5|TWO_SIDED|95.0|-18.67|9.17|||Cochran-Mantel-Haenszel|||||9.17|-18.67|0.500
72545935|NCT01533428|144621742|SUPERIORITY_OR_OTHER|||||||0.169|TWO_SIDED||||||Cochran-Mantel-Haenszel|Analysis of Cochran-Mantel-Haenszel test model including treatment, gender, pain score at baseline, HbA1c at screening and site as factors/covariates.||Comparing the difference between capsaicin 8% and placebo for counts by category using a Cochran-Mantel-Haenszel test.||||0.169
72411894|NCT00406029|144331719|SUPERIORITY_OR_OTHER||Difference in LS Means|0.3||||0.355|TWO_SIDED|95.0|-0.4|1.0|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.0|-0.4|0.355
72411895|NCT00406029|144331719|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.1||||0.831|TWO_SIDED|94.0|-0.8|0.7|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.7|-0.8|0.831
72545936|NCT01533428|144621743|SUPERIORITY_OR_OTHER||LS Mean Difference|1.7||||0.32|TWO_SIDED|95.0|-1.6|5.0|||ANCOVA|Analysis of covariance model including treatment, gender, pain score at baseline, HbA1c at screening and site as factors/covariates.||The statistical comparison between Baseline and Week 8 was made using two-sided tests at the 5% significance level.||5.0|-1.6|0.320
72411896|NCT00406029|144331719|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.5||||0.198|TWO_SIDED|95.0|-1.2|0.2|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.2|-1.2|0.198
72545937|NCT01533428|144621743|SUPERIORITY_OR_OTHER||LS Mean Difference|1.2||||0.473|TWO_SIDED|95.0|-2.1|4.5|||ANCOVA|Analysis of covariance model including treatment, gender, pain score at baseline, HbA1c at screening and site as factors/covariates.||The statistical comparison between Baseline and Week 12 was made using two-sided tests at the 5% significance level.||4.5|-2.1|0.473
72545938|NCT01533428|144621743|SUPERIORITY_OR_OTHER||LS Mean Difference|1.7||||0.514|TWO_SIDED|95.0|-4.4|2.2|||ANCOVA|||The statistical comparison between Baseline and Week 2 was made using two-sided tests at the 5% significance level.||2.2|-4.4|0.514
72580346|NCT04467840|144690230|SUPERIORITY||Risk Difference (RD)|12.75||||0.023|TWO_SIDED|95.0|1.9|23.6|||Cochran-Mantel-Haenszel|||||23.60|1.90|0.023
72580347|NCT04467840|144690231|SUPERIORITY||Risk Difference (RD)|-4.12||||0.561|TWO_SIDED|95.0|-18.07|9.82|||Cochran-Mantel-Haenszel|||||9.82|-18.07|0.561
72580348|NCT04467840|144690232|SUPERIORITY||Hazard Ratio (HR)|1.44||||0.01|TWO_SIDED|95.0|1.07|1.93|||Log Rank|||||1.93|1.07|0.01
72580349|NCT04467840|144690233|SUPERIORITY||Hazard Ratio (HR)|0.88||||0.545|TWO_SIDED|95.0|0.58|1.34|||Log Rank|||||1.34|0.58|0.545
72580350|NCT04467840|144690234|SUPERIORITY||Hazard Ratio (HR)|1.276||||0.1|TWO_SIDED|95.0|0.94|1.732|||Log Rank|||||1.732|0.940|0.100
72580351|NCT04467840|144690236|SUPERIORITY||Risk Difference (RD)|-10.5||||0.012|TWO_SIDED|95.0|-18.44|-2.57|||Cochran-Mantel-Haenszel|||||-2.57|-18.44|0.012
72580352|NCT04467840|144690237|SUPERIORITY||Risk Difference (RD)|7.2||||0.304|TWO_SIDED|95.0|-6.46|20.86|||Cochran-Mantel-Haenszel|||||20.86|-6.46|0.304
72580353|NCT04467840|144690238|SUPERIORITY||Risk Difference (RD)|-9.22||||0.019|TWO_SIDED|95.0|-16.63|-1.8|||Cochran-Mantel-Haenszel|||||-1.80|-16.63|0.019
72580354|NCT04467840|144690239|SUPERIORITY||Risk Difference (RD)|7.37||||0.273|TWO_SIDED|95.0|-5.66|20.39|||Cochran-Mantel-Haenszel|||||20.39|-5.66|0.273
72580355|NCT04848480|144690276|NON_INFERIORITY|Non-inferiority was considered confirmed if the estimated treatment difference was below 0.3%.|Treatment difference|0.05||||0.0065|TWO_SIDED|95.0|-0.13|0.23|||ANCOVA|||Change from baseline in HbA1c after 26 weeks was analysed using ANCOVA model with treatment, region, HbA1c group at screening and pre-trial basal insulin treatment as fixed factors, and baseline response as covariate.||0.23|-0.13|0.0065
72580356|NCT03176134|144690297|OTHER||Estimated Difference|6.5|||||TWO_SIDED|95.0|-12.2|25.3|||||The estimated difference in the clinical success rate and 2-sided 95% confidence interval (CI) were calculated using the unstratified method of Miettinen and Nurminen.|||25.3|-12.2|
72580357|NCT03176134|144690297|OTHER||Estimated Difference|-12.5|||||TWO_SIDED|95.0|-28.7|3.7|||||The estimated difference in the clinical success rate and 2-sided 95% CI were calculated using the unstratified method of Miettinen and Nurminen.|||3.7|-28.7|
72580358|NCT03176134|144690297|OTHER||Estimated Difference|0.0|||||TWO_SIDED|95.0|0.0|0.0|||||The estimated difference in the clinical success rate and 2-sided 95% CI were calculated using the unstratified method of Miettinen and Nurminen.|||0.0|0.0|
72580359|NCT03176134|144690297|OTHER||Estimated Difference|1.3|||||TWO_SIDED|95.0|-10.7|13.4|||||The estimated difference in the clinical success rate and 2-sided 95% CI were calculated using the unstratified method of Miettinen and Nurminen.|||13.4|-10.7|
72580360|NCT03176134|144690298|OTHER||Estimated Difference|0.0|||||TWO_SIDED|95.0|0.0|0.0|||||The estimated difference in the clinical success rate and 2-sided 95% confidence interval (CI) were calculated using the unstratified method of Miettinen and Nurminen.|||0.0|0.0|
72580361|NCT03176134|144690298|OTHER||Estimated Difference|0.0|||||TWO_SIDED|95.0|0.0|0.0|||||The estimated difference in the clinical success rate and 2-sided 95% CI were calculated using the unstratified method of Miettinen and Nurminen.|||0.0|0.0|
72580362|NCT03176134|144690298|OTHER||Estimated Difference|0.0|||||TWO_SIDED|95.0|0.0|0.0|||||The estimated difference in the clinical success rate and 2-sided 95% CI were calculated using the unstratified method of Miettinen and Nurminen.|||0.0|0.0|
72580363|NCT03176134|144690298|OTHER||Estimated Difference|0.0|||||TWO_SIDED|95.0|0.0|0.0|||||The estimated difference in the clinical success rate and 2-sided 95% CI were calculated using the unstratified method of Miettinen and Nurminen.|||0.0|0.0|
72580364|NCT03718832|144690394|SUPERIORITY||Mean Difference (Net)|-0.0333487|STANDARD_ERROR_OF_MEAN|0.1943638||0.8638688|TWO_SIDED|95.0|-0.415628|0.3489306||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|t-test, 2 sided|||Unadjusted mean difference, 6 months after trial enrollment||0.3489306|-0.415628|0.8638688
72580365|NCT03718832|144690394|SUPERIORITY||Mean Difference (Net)|-0.0066385|STANDARD_ERROR_OF_MEAN|0.1853917||0.9714571|TWO_SIDED|95.0|-0.371329|0.358052||Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|Regression, Linear|||Adjusted mean difference for full controls, 6 months after trial enrollment||0.358052|-0.371329|0.9714571
72580366|NCT03718832|144690395|SUPERIORITY||Mean Difference (Net)|0.1409446|STANDARD_ERROR_OF_MEAN|0.2106711||0.5039565|TWO_SIDED|95.0|-0.2735162|0.5554053||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|t-test, 2 sided|||Unadjusted mean difference, 12 months after trial enrollment||0.5554053|-0.2735162|0.5039565
72580367|NCT03718832|144690395|SUPERIORITY||Mean Difference (Net)|0.1213915|STANDARD_ERROR_OF_MEAN|0.2126328||0.5684854|TWO_SIDED|95.0|-0.2970052|0.5397882||Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|Regression, Linear|||Adjusted mean difference for full controls, 12 months after trial enrollment||0.5397882|-0.2970052|0.5684854
72580368|NCT03718832|144690396|SUPERIORITY||Mean Difference (Net)|-13.26835|STANDARD_ERROR_OF_MEAN|10.90353||0.2247426|TWO_SIDED|95.0|-34.73804|8.201347||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|t-test, 2 sided|||Unadjusted mean difference, 6 months after trial enrollment||8.201347|-34.73804|0.2247426
72545939|NCT01533428|144621744|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1||||0.719|TWO_SIDED|95.0|-0.5|0.7|||ANCOVA|Analysis of covariance model including treatment, gender, pain score at baseline, HbA1c at screening and site as factors/covariates.||Comparing the difference between capsaicin 8% and placebo for change from Baseline at Week 2 was completed using ANCOVA model.||0.7|-0.5|0.719
72545940|NCT01533428|144621744|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3||||0.334|TWO_SIDED|95.0|-0.8|0.3|||ANCOVA|Analysis of covariance model including treatment, gender, pain score at baseline, HbA1c at screening and site as factors/covariates.||Comparing the difference between capsaicin 8% and placebo for change from Baseline at Week 8 was completed using ANCOVA model.||0.3|-0.8|0.334
72545941|NCT01533428|144621744|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1||||0.726|TWO_SIDED|95.0|-0.7|0.5|||ANCOVA|Analysis of covariance model including treatment, gender, pain score at baseline, HbA1c at screening and site as factors/covariates.||Comparing the difference between capsaicin 8% and placebo for change from Baseline at Week 12 was completed using ANCOVA model.||0.5|-0.7|0.726
72580369|NCT03718832|144690396|SUPERIORITY||Mean Difference (Net)|-12.20164|STANDARD_ERROR_OF_MEAN|11.25555||0.2794015|TWO_SIDED|95.0|-34.37119|9.9679||Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|Regression, Linear|||Adjusted mean difference for full controls, 6 months after trial enrollment||9.9679|-34.37119|0.2794015
72545942|NCT01533428|144621745|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1||||0.841|TWO_SIDED|95.0|-0.6|0.5|||ANCOVA|Analysis of covariance model including treatment, gender, pain score at baseline, HbA1c at screening and site as factors/covariates.||Comparing the difference between capsaicin 8% and placebo for change from Baseline at Week 2 was completed using ANCOVA model.||0.5|-0.6|0.841
72545943|NCT01533428|144621745|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4||||0.171|TWO_SIDED|95.0|-0.9|0.2|||ANCOVA|Analysis of covariance model including treatment, gender, pain score at baseline, HbA1c at screening and site as factors/covariates.||Comparing the difference between capsaicin 8% and placebo for change from Baseline at Week 8 was completed using ANCOVA model.||0.2|-0.9|0.171
72545944|NCT01533428|144621745|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1||||0.595|TWO_SIDED|95.0|-0.7|0.4|||ANCOVA|Analysis of covariance model including treatment, gender, pain score at baseline, HbA1c at screening and site as factors/covariates.||Comparing the difference between capsaicin 8% and placebo for change from Baseline at Week 12 was completed using ANCOVA model.||0.4|-0.7|0.595
72580370|NCT03718832|144690396|SUPERIORITY||Mean Difference (Net)|13.12548|STANDARD_ERROR_OF_MEAN|9.550462||0.1708328|TWO_SIDED|95.0|-5.703702|31.95466||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|t-test, 2 sided|||Unadjusted mean difference, 12 months after trial enrollment||31.95466|-5.703702|0.1708328
72580371|NCT03718832|144690396|SUPERIORITY||Mean Difference (Net)|11.47577|STANDARD_ERROR_OF_MEAN|10.59479||0.2801138|TWO_SIDED|95.0|-9.422762|32.3743||Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|Regression, Linear|||Adjusted mean difference for full controls, 12 months after trial enrollment||32.3743|-9.422762|0.2801138
72580372|NCT03718832|144690397|SUPERIORITY||Mean Difference (Net)|-8.135585|STANDARD_ERROR_OF_MEAN|6.325031||0.1991028|TWO_SIDED|95.0|-20.57023|4.299061||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|t-test, 2 sided|||Unadjusted mean difference, 6 months after trial enrollment||4.299061|-20.57023|0.1991028
72580373|NCT03718832|144690397|SUPERIORITY||Mean Difference (Net)|3.493798|STANDARD_ERROR_OF_MEAN|1.761916||0.0480884|TWO_SIDED|95.0|0.0295297|6.958066||Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|Regression, Linear|||Adjusted mean difference for full controls, 6 months after trial enrollment||6.958066|0.0295297|0.0480884
72580374|NCT03718832|144690397|SUPERIORITY||Mean Difference (Net)|-9.681804|STANDARD_ERROR_OF_MEAN|6.34136||0.1276817|TWO_SIDED|95.0|-22.15188|2.788269||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|t-test, 2 sided|||Unadjusted mean difference, 12 months after trial enrollment||2.788269|-22.15188|0.1276817
72580375|NCT03718832|144690397|SUPERIORITY||Mean Difference (Net)|1.658257|STANDARD_ERROR_OF_MEAN|1.706497||0.3318554|TWO_SIDED|95.0|-1.698022|5.014535||Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|Regression, Linear|||Adjusted mean difference for full controls, 12 months after trial enrollment||5.014535|-1.698022|0.3318554
72580376|NCT03718832|144690398|SUPERIORITY||Mean Difference (Net)|-0.8749266|STANDARD_ERROR_OF_MEAN|0.9355095||0.3502313|TWO_SIDED|95.0|-2.714084|0.9642311||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|t-test, 2 sided|||Unadjusted mean difference, 6 months after trial enrollment||0.9642311|-2.714084|0.3502313
72580377|NCT03718832|144690398|SUPERIORITY||Mean Difference (Net)|0.5608222|STANDARD_ERROR_OF_MEAN|0.2708671||0.0390797|TWO_SIDED|95.0|0.0282451|1.093399||Adjusted mean difference for full controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|Regression, Linear|||Adjusted mean difference for full controls, 6 months after trial enrollment||1.093399|0.0282451|0.0390797
72580378|NCT03718832|144690398|SUPERIORITY||Mean Difference (Net)|-1.450197|STANDARD_ERROR_OF_MEAN|0.9508997||0.1281032|TWO_SIDED|95.0|-3.320109|0.419716||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|t-test, 2 sided|||Unadjusted mean difference, 12 months after trial enrollment||0.419716|-3.320109|0.1281032
72580379|NCT03718832|144690398|SUPERIORITY||Mean Difference (Net)|0.2794625|STANDARD_ERROR_OF_MEAN|0.2717457||0.3044732|TWO_SIDED|95.0|-0.2549974|0.8139224||Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|Regression, Linear|||Adjusted mean difference for full controls, 12 months after trial enrollment||0.8139224|-0.2549974|0.3044732
72411897|NCT00406029|144331719|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.1||||0.792|TWO_SIDED|95.0|-0.8|0.6|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.6|-0.8|0.792
72545945|NCT01533428|144621747|SUPERIORITY_OR_OTHER||LS Mean Difference|-9.0||||0.03|TWO_SIDED|95.0|-17.2|-0.9|||ANCOVA|Analysis of covariance model including treatment,gender, pain score at baseline, HbA1c at screening and site as factors/covariates.||All statistical comparisons were made using two-sided tests at the 5% significance level.||-0.9|-17.2|0.030
72545946|NCT01533428|144621747|SUPERIORITY_OR_OTHER||LS Mean Difference|-9.5||||0.02|TWO_SIDED|95.0|-17.4|-1.5|||ANCOVA|Analysis of covariance model including treatment,gender, pain score at baseline, HbA1c at screening and site as factors/covariates.||All statistical comparisons were made using two-sided tests at the 5% significance level.||-1.5|-17.4|0.020
72545947|NCT01364870|144621752|SUPERIORITY|||||||0.016||||||The p value was adjusted using Bonferroni's method to account for the multiple comparisons.|Kruskal-Wallis|||There were instances of missing data due to patient time restraints and patient refusal.||||0.016
72545948|NCT01364870|144621753|SUPERIORITY|||||||0.008||||||P-value was adjusted using Bonferroni's method to account for multiple comparisons.|Kruskal-Wallis|||There were instances of missing data due to patient time restraints and patient refusal.||||0.008
72545949|NCT01200394|144621754|SUPERIORITY||Geometric Mean Ratio|0.843||||0.9889|TWO_SIDED|95.0|0.728|0.975||Posterior distribution was used to calculate a probability (presented as P-value) that PF-00489791 has a greater than 0% reduction in UACR compared to placebo.|ANCOVA||Geometric mean ratio and corresponding 95% credible intervals were calculated.|Analysis of covariance (ANCOVA) model within an outlier robust Bayesian framework on normal logarithmic scale with treatment as fixed effect, baseline UACR and baseline supine systolic blood pressure (BP) as covariate. Values were back-transformed from log scale. Model used informative prior distribution for placebo.||0.975|0.728|0.9889
72545950|NCT01200394|144621754|SUPERIORITY|||||||0.2402|TWO_SIDED|||||Posterior distribution was used to calculate a probability (presented as P-value) that PF-00489791 has a greater than or equal to 20% reduction in UACR compared to placebo.|ANCOVA|||ANCOVA model within an outlier robust Bayesian framework on normal logarithmic scale with treatment as fixed effect, baseline UACR and baseline supine systolic BP as covariate. Values were back-transformed from log scale. Model used informative prior distribution for placebo.||||0.2402
72545951|NCT01200394|144621755|SUPERIORITY||Geometric Mean Ratio|0.8759||||0.0382|TWO_SIDED|95.0|0.7727|0.9927|||Mixed Models Analysis|||Week 3: Mixed model repeated measures (MMRM) on normal logarithmic scale with baseline, baseline supine systolic BP, visit, treatment, baseline by visit interaction and treatment by visit interaction as fixed effects. Unstructured covariance matrix was used to estimate variances and covariance within participant across time points. Values were back-transformed from log scale.||0.9927|0.7727|0.0382
72545952|NCT01200394|144621755|SUPERIORITY||Geometric Mean Ratio|0.8311||||0.0112|TWO_SIDED|95.0|0.7208|0.9584|||Mixed Models Analysis|||Week 6: MMRM on normal logarithmic scale with baseline, baseline supine systolic BP, visit, treatment, baseline by visit interaction and treatment by visit interaction as fixed effects. Unstructured covariance matrix was used to estimate variances and covariance within participant across time points. Values were back-transformed from log scale.||0.9584|0.7208|0.0112
72545953|NCT01200394|144621755|SUPERIORITY||Geometric Mean Ratio|0.8816||||0.149|TWO_SIDED|95.0|0.7427|1.0465|||Mixed Models Analysis|||Week 16: MMRM on normal logarithmic scale with baseline, baseline supine systolic BP, visit, treatment, baseline by visit interaction and treatment by visit interaction as fixed effects. Unstructured covariance matrix was used to estimate variances and covariance within participant across time points. Values were back-transformed from log scale.||1.0465|0.7427|0.1490
72545954|NCT01200394|144621756|SUPERIORITY||Geometric Mean Ratio|0.8565||||0.0297|TWO_SIDED|95.0|0.745|0.9847|||Mixed Models Analysis|||Week 3: MMRM on normal logarithmic scale with baseline, baseline supine systolic BP, visit, treatment, baseline by visit interaction and treatment by visit interaction as fixed effects. Unstructured covariance matrix was used to estimate variances and covariance within participant across time points. Values were back-transformed from log scale.||0.9847|0.7450|0.0297
72545955|NCT01200394|144621756|SUPERIORITY||Geometric Mean Ratio|0.8524||||0.0305|TWO_SIDED|95.0|0.7376|0.985|||Mixed Models Analysis|||Week 6: MMRM on normal logarithmic scale with baseline, baseline supine systolic BP, visit, treatment, baseline by visit interaction and treatment by visit interaction as fixed effects. Unstructured covariance matrix was used to estimate variances and covariance within participant across time points. Values were back-transformed from log scale.||0.9850|0.7376|0.0305
72545956|NCT01200394|144621756|SUPERIORITY||Geometric Mean Ratio|0.7937||||0.0068|TWO_SIDED|95.0|0.6717|0.9378|||Mixed Models Analysis|||Week 12: MMRM on normal logarithmic scale with baseline, baseline supine systolic BP, visit, treatment, baseline by visit interaction and treatment by visit interaction as fixed effects. Unstructured covariance matrix was used to estimate variances and covariance within participant across time points. Values were back-transformed from log scale.||0.9378|0.6717|0.0068
72411898|NCT00406029|144331719|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.1||||0.749|TWO_SIDED|95.0|-0.8|0.6|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.6|-0.8|0.749
72411899|NCT00406029|144331719|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.1||||0.896|TWO_SIDED|95.0|-0.8|0.7|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.7|-0.8|0.896
72411900|NCT00406029|144331719|SUPERIORITY_OR_OTHER||Difference in LS Means|0.3||||0.48|TWO_SIDED|95.0|-0.5|1.0|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.0|-0.5|0.480
72411901|NCT00406029|144331719|SUPERIORITY_OR_OTHER||Difference in LS Means|0.4||||0.285|TWO_SIDED|95.0|-0.4|1.2|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.2|-0.4|0.285
72545957|NCT01200394|144621756|SUPERIORITY||Geometric Mean Ratio|0.8634||||0.1151|TWO_SIDED|95.0|0.719|1.0368|||Mixed Models Analysis|||Week 16: MMRM on normal logarithmic scale with baseline, baseline supine systolic BP, visit, treatment, baseline by visit interaction and treatment by visit interaction as fixed effects. Unstructured covariance matrix was used to estimate variances and covariance within participant across time points. Values were back-transformed from log scale.||1.0368|0.7190|0.1151
72545958|NCT01200394|144621757|SUPERIORITY||Geometric Mean Ratio|0.9816||||0.3585|TWO_SIDED|95.0|0.9434|1.0214|||Mixed Models Analysis|||Week 3: MMRM on normal logarithmic scale with change from baseline as response variable and baseline, baseline supine systolic BP, visit, treatment, baseline by visit interaction and treatment by visit interaction as fixed effects. Unstructured covariance matrix was used to estimate variances and covariance within participant across time points. Values were back-transformed from log scale.||1.0214|0.9434|0.3585
72545959|NCT01200394|144621757|SUPERIORITY||Geometric Mean Ratio|0.9939||||0.7475|TWO_SIDED|95.0|0.9577|1.0315|||Mixed Models Analysis|||Week 6: MMRM on normal logarithmic scale with change from baseline as response variable and baseline, baseline supine systolic BP, visit, treatment, baseline by visit interaction and treatment by visit interaction as fixed effects. Unstructured covariance matrix was used to estimate variances and covariance within participant across time points. Values were back-transformed from log scale.||1.0315|0.9577|0.7475
72411902|NCT00406029|144331719|SUPERIORITY_OR_OTHER||Difference in LS Means|0.5||||0.212|TWO_SIDED|95.0|-0.3|1.3|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.3|-0.3|0.212
72411903|NCT00406029|144331719|SUPERIORITY_OR_OTHER||Difference in LS Means|0.1||||0.883|TWO_SIDED|95.0|-0.9|1.0|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.0|-0.9|0.883
72411904|NCT00406029|144331719|SUPERIORITY_OR_OTHER||Difference in LS Means|0.0||||0.947|TWO_SIDED|95.0|-0.9|0.9|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.9|-0.9|0.947
72411905|NCT00406029|144331719|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.2||||0.663|TWO_SIDED|95.0|-1.1|0.7|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.7|-1.1|0.663
72580380|NCT03718832|144690399|SUPERIORITY||Mean Difference (Net)|9.768353|STANDARD_ERROR_OF_MEAN|5.933945||0.1007463|TWO_SIDED|95.0|-1.907847|21.44455||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|t-test, 2 sided|||Unadjusted mean difference, 6 months after trial enrollment||21.44455|-1.907847|0.1007463
72411906|NCT00406029|144331719|SUPERIORITY_OR_OTHER||Difference in LS Means|0.7||||0.157|TWO_SIDED|95.0|-0.3|1.6|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.6|-0.3|0.157
72411907|NCT00406029|144331719|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.5||||0.283|TWO_SIDED|95.0|-1.4|0.4|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.4|-1.4|0.283
72580381|NCT03718832|144690399|SUPERIORITY||Mean Difference (Net)|4.472004|STANDARD_ERROR_OF_MEAN|5.150772||0.3859868|TWO_SIDED|95.0|-5.66534|14.60935||Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|Regression, Linear|||Adjusted mean difference for full controls, 6 months after trial enrollment||14.60935|-5.66534|0.3859868
72580382|NCT03718832|144690399|SUPERIORITY||Mean Difference (Net)|-0.5461143|STANDARD_ERROR_OF_MEAN|6.440905||0.9324908|TWO_SIDED|95.0|-13.22545|12.13323||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|Regression, Linear|||Unadjusted mean difference, 12 months after trial enrollment||12.13323|-13.22545|0.9324908
72580383|NCT03718832|144690399|SUPERIORITY||Mean Difference (Net)|-2.752831|STANDARD_ERROR_OF_MEAN|5.754947||0.6328075|TWO_SIDED|95.0|-14.08487|8.579205||Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|Regression, Linear|||Adjusted mean difference for full controls, 12 months after trial enrollment||8.579205|-14.08487|0.6328075
72580384|NCT03718832|144690400|SUPERIORITY||Mean Difference (Net)|8.352141|STANDARD_ERROR_OF_MEAN|4.663846||0.0743062|TWO_SIDED|95.0|-0.8250086|17.52929||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|t-test, 2 sided|||Unadjusted mean difference, 6 months after trial enrollment.||17.52929|-0.8250086|0.0743062
72411908|NCT00406029|144331719|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.1||||0.768|TWO_SIDED|95.0|-1.0|0.7|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.7|-1.0|0.768
72411909|NCT00406029|144331719|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.4||||0.334|TWO_SIDED|95.0|-1.3|0.4|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.4|-1.3|0.334
72411910|NCT00406029|144331719|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.3||||0.465|TWO_SIDED|95.0|-1.2|0.6|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.6|-1.2|0.465
72411911|NCT00406029|144331719|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.2||||0.688|TWO_SIDED|95.0|-1.2|0.8|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.8|-1.2|0.688
72411912|NCT00406029|144331719|SUPERIORITY_OR_OTHER||Difference in LS Means|0.9||||0.062|TWO_SIDED|95.0|0.0|1.8|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.8|0.0|0.062
72411913|NCT00406029|144331719|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.3||||0.579|TWO_SIDED|95.0|-1.2|0.7|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.7|-1.2|0.579
72411914|NCT00406029|144331719|SUPERIORITY_OR_OTHER||Difference in LS Means|0.2||||0.644|TWO_SIDED|95.0|-0.7|1.2|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.2|-0.7|0.644
72545960|NCT01200394|144621757|SUPERIORITY||Geometric Mean Ratio|0.9866||||0.4972|TWO_SIDED|95.0|0.9488|1.0259|||Mixed Models Analysis|||Week 12: MMRM on normal logarithmic scale with change from baseline as response variable and baseline, baseline supine systolic BP, visit, treatment, baseline by visit interaction and treatment by visit interaction as fixed effects. Unstructured covariance matrix was used to estimate variances and covariance within participant across time points. Values were back-transformed from log scale.||1.0259|0.9488|0.4972
72545961|NCT01200394|144621757|SUPERIORITY||Geometric Mean Ratio|1.0024||||0.9146|TWO_SIDED|95.0|0.9588|1.0481|||Mixed Models Analysis|||Week 16: MMRM on normal logarithmic scale with change from baseline as response variable and baseline, baseline supine systolic BP, visit, treatment, baseline by visit interaction and treatment by visit interaction as fixed effects. Unstructured covariance matrix was used to estimate variances and covariance within participant across time points. Values were back-transformed from log scale.||1.0481|0.9588|0.9146
72411915|NCT00406029|144331719|SUPERIORITY_OR_OTHER||Difference in LS Means|0.1||||0.825|TWO_SIDED|95.0|-0.8|1.0|||ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.0|-0.8|0.825
72411916|NCT00406029|144331719|SUPERIORITY_OR_OTHER||Difference in LS Means|0.5||||0.233|TWO_SIDED|95.0|-0.3|1.4|||ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.4|-0.3|0.233
72411917|NCT00406029|144331719|SUPERIORITY_OR_OTHER||Difference in LS Means|0.1||||0.853|TWO_SIDED|95.0|-0.8|1.0|||ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.0|-0.8|0.853
72411918|NCT00406029|144331719|SUPERIORITY_OR_OTHER||Difference in LS Means|0.2||||0.592|TWO_SIDED|95.0|-0.6|1.1|||ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.1|-0.6|0.592
72411919|NCT03669081|144331731|OTHER|The null hypothesis for the test was no difference between groups.||||||0.006||||||The significance level for this test was 0.05.|Wilcoxon (Mann-Whitney)|We used an exact Wilcoxon rank sum test due to the skewed nature of the morphine equivalents data and the small sample sizes in each group.||||||0.006
72411920|NCT03669081|144331732|OTHER|The null hypothesis was no difference between groups.||||||0.029|||||||Exact Wilcoxon rank sum test|||||||0.029
72411921|NCT03669081|144331733|NON_INFERIORITY|We conducted a 1-sided non-inferiority test using an alpha level of 0.025, for a comparison of the fold change of creatinine levels (pre-operative creatinine/post-operative creatinine) in the Toradol group. Our minimum non-inferiority margin was 0.5, ie the post-operative creatinine level could only increase to at most two times the pre-operative creatinine level.|||||<|0.0001||||||This p-value was compared to a significance threshold of 0.025.|Wilcoxon (Mann-Whitney)|||The safety outcome was used to power our study.To achieve 90% power at a 2.5% significance level for testing that the post-surgery creatinine increase is at most two-fold (where 1.5 fold is expected), or alternatively for the pre-surgery creatinine group to be ≥0.5 times the post-surgery, we need 17 subjects in the toradol group. This calculation was based on a non-inferiority test (one sided t-test) using a coefficient of variation of 0.25 based on preliminary data.||||<0.0001
72411922|NCT03669081|144331734|OTHER|The null hypothesis was no difference between groups.||||||0.002|||||||t-test, 2 sided|||||||0.002
72411923|NCT03669081|144331735|OTHER|The null hypothesis was no difference between groups.|||||>|0.99|||||||Fisher Exact|||||||>0.99
72545962|NCT01200394|144621758|SUPERIORITY||Least Squares (LS) Mean Difference|-5.39|STANDARD_ERROR_OF_MEAN|1.2942|<|0.0001|TWO_SIDED|95.0|-7.94|-2.84|||Mixed Models Analysis|||Supine Systolic BP, Week 0: MMRM model included baseline, visit, treatment, baseline by visit interaction and treatment by visit interaction as fixed effects. The unstructured covariance matrix was used to estimate variances and covariance within participant across time points.||-2.84|-7.94|<0.0001
72580385|NCT03718832|144690400|SUPERIORITY||Mean Difference (Net)|5.971188|STANDARD_ERROR_OF_MEAN|3.902349||0.1270654|TWO_SIDED|95.0|-1.709219|13.65159||Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|Regression, Linear|||Adjusted mean difference for full controls, 6 months after trial enrollment||13.65159|-1.709219|0.1270654
72580386|NCT03718832|144690400|SUPERIORITY||Mean Difference (Net)|2.637485|STANDARD_ERROR_OF_MEAN|4.443227||0.553277|TWO_SIDED|95.0|-6.110146|11.38512||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|t-test, 2 sided|||Unadjusted mean difference, 12 months after trial enrollment||11.38512|-6.110146|0.553277
72545963|NCT01200394|144621758|SUPERIORITY||LS Mean Difference|-3.71|STANDARD_ERROR_OF_MEAN|0.849|<|0.0001|TWO_SIDED|95.0|-5.38|-2.04|||Mixed Models Analysis|||Supine Diastolic BP, Week 0: MMRM model included baseline, visit, treatment, baseline by visit interaction and treatment by visit interaction as fixed effects. The unstructured covariance matrix was used to estimate variances and covariance within participant across time points.||-2.04|-5.38|<0.0001
72545964|NCT01200394|144621758|SUPERIORITY||LS Mean Difference|-4.59|STANDARD_ERROR_OF_MEAN|0.9489|<|0.0001|TWO_SIDED|95.0|-6.46|-2.72|||Mixed Models Analysis|||Supine Mean BP, Week 0: MMRM model included baseline, visit, treatment, baseline by visit interaction and treatment by visit interaction as fixed effects. The unstructured covariance matrix was used to estimate variances and covariance within participant across time points.||-2.72|-6.46|<0.0001
72545965|NCT01200394|144621758|SUPERIORITY||LS Mean Difference|-0.52|STANDARD_ERROR_OF_MEAN|1.4056||0.7093|TWO_SIDED|95.0|-3.29|2.24|||Mixed Models Analysis|||Supine Systolic BP, Week 3: MMRM model included baseline, visit, treatment, baseline by visit interaction and treatment by visit interaction as fixed effects. The unstructured covariance matrix was used to estimate variances and covariance within participant across time points.||2.24|-3.29|0.7093
72545966|NCT01200394|144621758|SUPERIORITY||LS Mean Difference|0.4|STANDARD_ERROR_OF_MEAN|0.9089||0.6564|TWO_SIDED|95.0|-1.39|2.2|||Mixed Models Analysis|||Supine Diastolic BP, Week 3: MMRM model included baseline, visit, treatment, baseline by visit interaction and treatment by visit interaction as fixed effects. The unstructured covariance matrix was used to estimate variances and covariance within participant across time points.||2.20|-1.39|0.6564
72545967|NCT01200394|144621758|SUPERIORITY||LS Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|1.0334||0.8763|TWO_SIDED|95.0|-2.2|1.87|||Mixed Models Analysis|||Supine Mean BP, Week 3: MMRM model included baseline, visit, treatment, baseline by visit interaction and treatment by visit interaction as fixed effects. The unstructured covariance matrix was used to estimate variances and covariance within participant across time points.||1.87|-2.20|0.8763
72545968|NCT01200394|144621758|SUPERIORITY||LS Mean Difference|-0.48|STANDARD_ERROR_OF_MEAN|1.4926||0.7491|TWO_SIDED|95.0|-3.42|2.46|||Mixed Models Analysis|||Supine Systolic BP, Week 6: MMRM model included baseline, visit, treatment, baseline by visit interaction and treatment by visit interaction as fixed effects. The unstructured covariance matrix was used to estimate variances and covariance within participant across time points.||2.46|-3.42|0.7491
72545969|NCT01200394|144621758|SUPERIORITY||LS Mean Difference|-0.47|STANDARD_ERROR_OF_MEAN|0.9235||0.6141|TWO_SIDED|95.0|-2.29|1.35|||Mixed Models Analysis|||Supine Diastolic BP, Week 6: MMRM model included baseline, visit, treatment, baseline by visit interaction and treatment by visit interaction as fixed effects. The unstructured covariance matrix was used to estimate variances and covariance within participant across time points.||1.35|-2.29|0.6141
72545970|NCT01200394|144621758|SUPERIORITY||LS Mean Difference|-0.67|STANDARD_ERROR_OF_MEAN|1.0582||0.5281|TWO_SIDED|95.0|-2.75|1.42|||Mixed Models Analysis|||Supine Mean BP, Week 6: MMRM model included baseline, visit, treatment, baseline by visit interaction and treatment by visit interaction as fixed effects. The unstructured covariance matrix was used to estimate variances and covariance within participant across time points.||1.42|-2.75|0.5281
72545971|NCT01200394|144621758|SUPERIORITY||LS Mean Difference|0.8|STANDARD_ERROR_OF_MEAN|1.8764||0.6695|TWO_SIDED|95.0|-2.9|4.5|||Mixed Models Analysis|||Supine Systolic BP, Week 12: MMRM model included baseline, visit, treatment, baseline by visit interaction and treatment by visit interaction as fixed effects. The unstructured covariance matrix was used to estimate variances and covariance within participant across time points.||4.50|-2.90|0.6695
72545972|NCT01200394|144621758|SUPERIORITY||LS Mean Difference|-0.63|STANDARD_ERROR_OF_MEAN|1.073||0.5607|TWO_SIDED|95.0|-2.74|1.49|||Mixed Models Analysis|||Supine Diastolic BP, Week 12: MMRM model included baseline, visit, treatment, baseline by visit interaction and treatment by visit interaction as fixed effects. The unstructured covariance matrix was used to estimate variances and covariance within participant across time points.||1.49|-2.74|0.5607
72545973|NCT01200394|144621758|SUPERIORITY||LS Mean Difference|-0.27|STANDARD_ERROR_OF_MEAN|1.2722||0.8297|TWO_SIDED|95.0|-2.78|2.23|||Mixed Models Analysis|||Supine Mean BP, Week 12: MMRM model included baseline, visit, treatment, baseline by visit interaction and treatment by visit interaction as fixed effects. The unstructured covariance matrix was used to estimate variances and covariance within participant across time points.||2.23|-2.78|0.8297
72545974|NCT01200394|144621758|SUPERIORITY||LS Mean Difference|0.51|STANDARD_ERROR_OF_MEAN|1.7065||0.7644|TWO_SIDED|95.0|-2.85|3.87|||Mixed Models Analysis|||Supine Systolic BP, Week 16: MMRM model included baseline, visit, treatment, baseline by visit interaction and treatment by visit interaction as fixed effects. The unstructured covariance matrix was used to estimate variances and covariance within participant across time points.||3.87|-2.85|0.7644
72545975|NCT01200394|144621758|SUPERIORITY||LS Mean Difference|0.65|STANDARD_ERROR_OF_MEAN|0.9917||0.5123|TWO_SIDED|95.0|-1.3|2.61|||Mixed Models Analysis|||Supine Diastolic BP, Week 16: MMRM model included baseline, visit, treatment, baseline by visit interaction and treatment by visit interaction as fixed effects. The unstructured covariance matrix was used to estimate variances and covariance within participant across time points.||2.61|-1.30|0.5123
72545976|NCT01200394|144621758|SUPERIORITY||LS Mean Difference|0.46|STANDARD_ERROR_OF_MEAN|1.1355||0.6838|TWO_SIDED|95.0|-1.77|2.7|||Mixed Models Analysis|||Supine Mean BP, Week 16: MMRM model included baseline, visit, treatment, baseline by visit interaction and treatment by visit interaction as fixed effects. The unstructured covariance matrix was used to estimate variances and covariance within participant across time points.||2.70|-1.77|0.6838
72421533|NCT01181726|144354216|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|99.35|||||TWO_SIDED|90.0|92.21|107.06|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||107.06|92.21|
72545977|NCT01200394|144621760|SUPERIORITY||Geometric Mean Ratio|0.9282||||0.5422|TWO_SIDED|95.0|0.7297|1.1807|||Mixed Models Analysis|||Week 3: MMRM on normal logarithmic scale with change from baseline as response variable and baseline, baseline supine systolic BP, visit, treatment, baseline by visit interaction and treatment by visit interaction as fixed effects. Unstructured covariance matrix was used to estimate variances and covariance within participant across time points. Values were back-transformed from log scale.||1.1807|0.7297|0.5422
72552615|NCT02728102|144636043|SUPERIORITY|||||||0.945||||||Statistical significance was determined using a pre-specified threshold of 0.05|Chi-squared|||Proportion of participants achieving CR among the subset of participants who are not in CR at the time of randomization between the vaccine and the combined non-vaccine arms at 24 months Post Transplant.||||0.9450
72545978|NCT01200394|144621760|SUPERIORITY||Geometric Mean Ratio|0.7998||||0.049|TWO_SIDED|95.0|0.6402|0.999|||Mixed Models Analysis|||Week 6: MMRM on normal logarithmic scale with change from baseline as response variable and baseline, baseline supine systolic BP, visit, treatment, baseline by visit interaction and treatment by visit interaction as fixed effects. Unstructured covariance matrix was used to estimate variances and covariance within participant across time points. Values were back-transformed from log scale.||0.9990|0.6402|0.0490
72411924|NCT00389324|144331737|NON_INFERIORITY_OR_EQUIVALENCE|The administration effect between SC and IV was assessed by exponentiation of the difference in least squares means between study phases (Test minus Reference) and the corresponding 90% confidence interval (CI) for the geometric LSM ratio between study phases (Test/Reference) for AUC. The Test (SC) was to be considered non-inferior to Reference (IV) if the lower bound of 90% CIs for the geometric LSM ratios of AUC between the Test and Reference was above 0.80 (80%).|Geometric Least Square Mean Ratio|0.888||||||90.0|0.861|0.917|||ANOVA||An adjusted steady-state area under the concentration vs. time curve following SC administration based on IV dosing schedule was calculated as AUC0-τ,SC multiplied by 3 or 4 for subjects on every-3-week or every-4-week IV dosing schedule.|The IV phase was considered as the Reference study phase and the SC phase as the Test study phase. The ANOVA included calculation of least-squares means (LSM), differences between adjusted means and the standard error associated with these differences.||0.917|0.861|
72411925|NCT00795600|144331738|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.645|STANDARD_ERROR_OF_MEAN|3.364||0.849||95.0|-7.404|6.114||H01 (hypothesis): Micro detemir = micro NPH against the alternative H01: Microl detemir ≠ micro NPH.|ANCOVA|||The primary objective and endpoint of the trial was to compare the change in trunk fat mass (g) between insulin detemir versus insulin NPH at baseline and at week 26. A standard deviation of 5% was chosen based on a previous trial. A difference in trunk fat mass of 5% was considered clinically relevant also according to this trial.||6.114|-7.404|0.849
72545979|NCT01200394|144621760|SUPERIORITY||Geometric Mean Ratio|1.0435||||0.7264|TWO_SIDED|95.0|0.8211|1.3262|||Mixed Models Analysis|||Week 12: MMRM on normal logarithmic scale with change from baseline as response variable and baseline, baseline supine systolic BP, visit, treatment, baseline by visit interaction and treatment by visit interaction as fixed effects. Unstructured covariance matrix was used to estimate variances and covariance within participant across time points. Values were back-transformed from log scale.||1.3262|0.8211|0.7264
72545980|NCT01200394|144621760|SUPERIORITY||Geometric Mean Ratio|1.1154||||0.3733|TWO_SIDED|95.0|0.8761|1.4201|||Mixed Models Analysis|||Week 16: MMRM on normal logarithmic scale with change from baseline as response variable and baseline, baseline supine systolic BP, visit, treatment, baseline by visit interaction and treatment by visit interaction as fixed effects. Unstructured covariance matrix was used to estimate variances and covariance within participant across time points. Values were back-transformed from log scale.||1.4201|0.8761|0.3733
72545981|NCT01513551|144621814|OTHER||Risk Difference (RD)|6.8|||||TWO_SIDED|95.0|-1.4|15.0|||Miettinen & Nurminen|||||15.0|-1.4|
72545982|NCT01513551|144621814|OTHER||Risk Difference (RD)|9.5|||||TWO_SIDED|95.0|1.1|17.7|||Miettinen & Nurminen|||||17.7|1.1|
72545983|NCT00094302|144621823|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.89||||0.14|TWO_SIDED|95.0|0.77|1.04||No covariate adjustment|Log Rank|Two-sided log rand test (0.05 Type 1 error)|Spironolactone compared to Placebo|Composite endpoint was compared by trial arm using logrank test of time to first event from time of randomization. Time to event was the time at which the first observed event component of the composite endpoint was observed. This endpoint was adjudicated by the TOPCAT clinical endpoints committee. There were 320 subjects in the Spironolactone group and 351 subjects in Placebo group with a confirmed event. Subjects who did not experience this endpoint were censored at time of last contact.||1.04|0.77|0.14
72545984|NCT00094302|144621824|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.9||||0.35|TWO_SIDED|95.0|0.73|1.12||No covariate adjustment|Log Rank|Two-sided log rand test (0.05 Type 1 error)|Spironolactone compared to Placebo|"This endpoint was compared by trial arm (spironolactone vs. placebo) using a logrank test of time to event from the time of randomization. Subjects who did not experience this endpoint were censored at the time of their last contact.~This endpoint was adjudicated by the TOPCAT clinical endpoints committee. There were 336 subjects (160 in the Spironolactone group and 176 in the Placebo group) with a confirmed event."||1.12|0.73|0.35
72545985|NCT00094302|144621825|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.6||||0.48|TWO_SIDED|95.0|0.14|2.5||No covariate adjustment|Log Rank|Two-sided log rand test (0.05 Type 1 error)|Spironolactone compared to Placebo|"This endpoint was compared by trial arm (spironolactone vs. placebo) using a logrank test of time to first event from the time of randomization. Subjects who did not experience this endpoint were censored at the time of their last contact.~This endpoint was adjudicated by the TOPCAT clinical endpoints committee. There were 8 subjects (3 in the Spironolactone group and 5 in the Placebo group) with a confirmed event."||2.50|0.14|0.48
72545986|NCT00094302|144621826|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.83||||0.04|TWO_SIDED|95.0|0.69|0.99||No covariate adjustment|Log Rank|Two-sided log rand test (0.05 Type 1 error)|Spironolactone compared to Placebo|"This endpoint was compared by trial arm (spironolactone vs. placebo) using a logrank test of time to first event from the time of randomization. Subjects who did not experience this endpoint were censored at the time of their last contact.~This endpoint was adjudicated by the TOPCAT clinical endpoints committee. There were 451 subjects (206 in the Spironolactone group and 245 in the Placebo group) who have been confirmed to have experienced the event"||0.99|0.69|0.04
72545987|NCT00094302|144621827|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.91||||0.29|TWO_SIDED|95.0|0.77|1.08||No covariate adjustment|Log Rank|Two-sided log rand test (0.05 Type 1 error)|Spironolactone compared to Placebo|Endpoint compared by trial arm using logrank test of time to event from randomization. Subjects who did not experience endpoint were censored at time of last contact. Attempts were made to determine vital status as of each subject's last potential visit, based on randomization, even if the subject ended study participation before then. This outcome was adjudicated. There were 252 events over 6,022 patient-years in Spironolactone arm and 274 events over 5,981 patient-years in Placebo arm.||1.08|0.77|0.29
72580387|NCT03718832|144690400|SUPERIORITY||Mean Difference (Net)|2.53149|STANDARD_ERROR_OF_MEAN|3.925307||0.519562|TWO_SIDED|95.0|-5.198658|10.26164||Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|Regression, Linear|||Adjusted mean difference for full controls, 12 months after trial enrollment||10.26164|-5.198658|0.519562
72580388|NCT03718832|144690401|SUPERIORITY||Mean Difference (Net)|-0.555117|STANDARD_ERROR_OF_MEAN|1.427417||0.6976216|TWO_SIDED|95.0|-3.363839|2.253605||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|t-test, 2 sided|||Unadjusted mean difference, 6 months after trial enrollment||2.253605|-3.363839|0.6976216
72580389|NCT03718832|144690401|SUPERIORITY||Mean Difference (Net)|-0.4977997|STANDARD_ERROR_OF_MEAN|1.041102||0.6329035|TWO_SIDED|95.0|-2.546815|1.551216||Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|Regression, Linear|||Adjusted mean difference for full controls, 6 months after trial enrollment||1.551216|-2.546815|0.6329035
72411926|NCT00795600|144331739|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.59|STANDARD_ERROR_OF_MEAN|3.478||0.948||95.0|-7.588|6.407||H01: Micro detemir = micro NPH against the alternative H01: Microl detemir ≠ micro NPH.|ANCOVA|||The primary objective and endpoint of the trial was to compare the change in trunk fat mass (g) between insulin detemir versus insulin NPH at baseline and at week 26. A standard deviation of 5% was chosen based on a previous trial. A difference in trunk fat mass of 5% was considered clinically relevant also according to this trial.||6.407|-7.588|0.948
72545988|NCT00094302|144621828|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.93||||0.28|TWO_SIDED|95.0|0.8|1.06||No covariate adjustment|Log Rank|Two-sided log rank test (0.05 Type 1 error)|Spironolactone compared to Placebo|Composite endpoint was compared by trial arm using logrank test of time to first event from time of randomization. Time to event was the time at which the first observed event component of the composite endpoint was observed. Component endpoints were adjudicated by the TOPCAT clinical endpoints committee. There were 382 subjects in Spironolactone group and 404 subjects in Placebo group with a confirmed event. Subjects who did not experience this endpoint were censored at time of last contact.||1.06|0.80|0.28
72545989|NCT00094302|144621829|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.89||||0.15|TWO_SIDED|95.0|0.76|1.04||No covariate adjustment|Log Rank|Two-sided log rank test (0.05 Type 1 error)|Spironolactone compared to Placebo|Endpoint was compared by trial arm using logrank test of time to first event from time of randomization. Time to event was the time at which the first observed event component of the composite endpoint was observed. Component endpoints were adjudicated by the TOPCAT clinical endpoints committee. There were 291 subjects in Spironolactone group and 320 subjects in Placebo group with a confirmed event. Subjects who did not experience this endpoint were censored at time of last contact.||1.04|0.76|0.15
72545990|NCT00094302|144621830|SUPERIORITY_OR_OTHER||incidence rate ratio|0.75||||0.03|TWO_SIDED|95.0|0.58|0.97||No covariate adjustment|Negative binomial regression||Spironolactone compared to Placebo|There were a total of 869 confirmed heart failure hospitalizations (394 in the Spironolactone group and 475 in the Placebo group) during the 11,471 person-years collected over the course of the TOPCAT trial (5,755 person-years in the Spironolactone group and 5,716 person-years in the Placebo group). The incidence rate of heart failure hospitalizations for each treatment group was compared using a negative binomial regression with a p-value threshold of 0.05 for statistical significance.||0.97|0.58|0.03
72545991|NCT00094302|144621831|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.96||||0.82|TWO_SIDED|95.0|0.67|1.38||No covariate adjustment|Log Rank|Two-sided log rank test (0.05 Type 1 error)|Spironolactone compared to Placebo|Composite endpoint was compared by trial arm using logrank test of time to first event from time of randomization. Time to event was the time at which the first observed event component of the composite endpoint was observed. Component endpoints were adjudicated by the TOPCAT clinical endpoints committee. There were 58 subjects in the Spironolactone group and 60 subjects in Placebo group with a confirmed event. Subjects who did not experience this endpoint were censored at time of last contact.||1.38|0.67|0.82
72545992|NCT00094302|144621832|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.08||||0.76|TWO_SIDED|95.0|0.64|1.83||No covariate adjustment|Log Rank|Two-sided log rank test (0.05 Type 1 error)|Spironolactone compared to Placebo|"This endpoint was compared by trial arm (spironolactone vs. placebo) using a logrank test of time to first event from the time of randomization. Subjects who did not experience this endpoint were censored at the time of their last contact.~This endpoint was adjudicated by the TOPCAT clinical endpoints committee. There were 56 subjects (29 in the Spironolactone group and 27 in the Placebo group) with confirmed events."||1.83|0.64|0.76
72545993|NCT00094302|144621833|SUPERIORITY_OR_OTHER||Hazard Ratio, log|1.02||||0.94|TWO_SIDED|95.0|0.69|1.5||No covariate adjustment|Log Rank|Two-sided log rank test (0.05 Type 1 error)|Spironolactone compared to Placebo|"This endpoint was compared by trial arm (spironolactone vs. placebo) using a logrank test of time to first event from the time of randomization. Subjects who did not experience this endpoint were censored at the time of their last contact.~This endpoint was adjudicated by the TOPCAT clinical endpoints committee. There were 103 subjects (52 in the Spironolactone group and 51 in the Placebo group) with confirmed events."||1.50|0.69|0.94
72545994|NCT00094302|144621834|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.0||||0.98|TWO_SIDED|95.0|0.71|1.42||No covariate adjustment|Log Rank|Two-sided log rand test (0.05 Type 1 error)|Spironolactone compared to Placebo|"This endpoint was compared by trial arm (spironolactone vs. placebo) using a logrank test of time to first event from the time of randomization. Subjects who did not experience this endpoint were censored at the time of their last contact.~This endpoint was adjudicated by the TOPCAT clinical endpoints committee. There were 129 subjects (65 in the Spironolactone group and 64 in the Placebo group) with confirmed events."||1.42|0.71|0.98
72552616|NCT02728102|144636043|SUPERIORITY|||||||0.1599||||||Statistical significance was determined using a pre-specified threshold of 0.05|Chi-squared|||A pairwise analysis of proportion of participants achieving CR among the subset of participants who are not in CR at the time of randomization between the vaccine arm and lenalidomide/GM-CSF arm is conducted at 1 year post transplant.||||0.1599
72552617|NCT02728102|144636043|SUPERIORITY|||||||0.8984||||||Statistical significance was determined using a pre-specified threshold of 0.05|Chi-squared|||A pairwise analysis of proportion of participants achieving CR among the subset of participants who are not in CR at the time of randomization between the vaccine arm and lenalidomide alone arm is conducted at 1 year post transplant.||||0.8984
72552618|NCT02728102|144636043|SUPERIORITY|||||||0.1757||||||Statistical significance was determined using a pre-specified threshold of 0.05|Chi-squared|||A pairwise analysis of proportion of participants achieving CR among the subset of participants who are not in CR at the time of randomization between lenalidomide/GM-CSF arm and lenalidomide alone arm is conducted at 1 year post transplant.||||0.1757
72552619|NCT02728102|144636044|SUPERIORITY|||||||0.161||||||Statistical significance was determined using a pre-specified threshold of 0.05|Gray's test for cumulative Incidence|||The null hypothesis is that there is no difference of Myeloma Progression between vaccine vs. non- vaccine arms.||||0.161
72552620|NCT02728102|144636045|SUPERIORITY|||||||0.116||||||Statistical significance was determined using a pre-specified threshold of 0.05|Gray's test for cumulative Incidence|||The null hypothesis is that there is no difference of Myeloma Progression between the vaccine arm and lenalidomide/GM-CSF arm.||||0.116
72552621|NCT02728102|144636045|SUPERIORITY|||||||0.519||||||Statistical significance was determined using a pre-specified threshold of 0.05|Gray's test for cumulative Incidence|||The null hypothesis is that there is no difference of Myeloma Progression between the vaccine arm and lenalidomide alone arm.||||0.519
72545995|NCT00094302|144621835|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.94||||0.73|TWO_SIDED|95.0|0.65|1.35||No covariate adjustment|Log Rank|Two-sided log rand test (0.05 Type 1 error)|Spironolactone compared to Placebo|"This endpoint was compared by trial arm (spironolactone vs. placebo) using a logrank test of time to first event from the time of randomization. Subjects who did not experience this endpoint were censored at the time of their last contact.~This endpoint was adjudicated by the TOPCAT clinical endpoints committee. There were 117 subjects (57 in the Spironolactone group and 60 in the Placebo group) with confirmed events."||1.35|0.65|0.73
72552622|NCT02728102|144636045|SUPERIORITY|||||||0.387||||||Statistical significance was determined using a pre-specified threshold of 0.05|Gray's test for cumulative Incidence|||The null hypothesis is that there is no difference of Myeloma Progression between the lenalidomide/GM-CSF arm and lenalidomide alone arm.||||0.387
72552623|NCT02728102|144636047|SUPERIORITY|||||||0.168||||||Statistical significance was determined using a pre-specified threshold of 0.05|Log Rank|||The null hypothesis is that there is no difference of Progression-Free Survival between vaccine vs. non- vaccine arms.||||0.168
72552624|NCT02728102|144636048|SUPERIORITY|||||||0.12||||||Statistical significance was determined using a pre-specified threshold of 0.05|Log Rank|||The null hypothesis is that there is no difference of Progression-Free Survival between the vaccine arm and lenalidomide/GM-CSF arm.||||0.120
72552625|NCT02728102|144636048|SUPERIORITY|||||||0.519||||||Statistical significance was determined using a pre-specified threshold of 0.05|Log Rank|||The null hypothesis is that there is no difference of Progression-Free Survival between the vaccine arm and lenalidomide alone arm.||||0.519
72552626|NCT02728102|144636048|SUPERIORITY|||||||0.387||||||Statistical significance was determined using a pre-specified threshold of 0.05|Log Rank|||The null hypothesis is that there is no difference of Progression-Free Survival between the lenalidomide/GM-CSF arm and lenalidomide alone arm.||||0.387
72552627|NCT02728102|144636049|SUPERIORITY|||||||0.563||||||Statistical significance was determined using a pre-specified threshold of 0.05|Log Rank|||The null hypothesis is that there is no difference of overall Survival between vaccine vs. non- vaccine arms.||||0.563
72552628|NCT02728102|144636050|SUPERIORITY|||||||0.308||||||Statistical significance was determined using a pre-specified threshold of 0.05|Log Rank|||The null hypothesis is that there is no difference of overall Survival between the vaccine arm and lenalidomide/GM-CSF arm.||||0.308
72552629|NCT02728102|144636050|SUPERIORITY|||||||0.99||||||Statistical significance was determined using a pre-specified threshold of 0.05|Log Rank|||The null hypothesis is that there is no difference of overall Survival between the vaccine arm and lenalidomide alone arm.||||0.990
72580390|NCT03718832|144690401|SUPERIORITY||Mean Difference (Net)|-1.386111|STANDARD_ERROR_OF_MEAN|1.812939||0.445181|TWO_SIDED|95.0|-4.954999|2.182777||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|t-test, 2 sided|||Unadjusted mean difference, 12 months after trial enrollment||2.182777|-4.954999|0.445181
72580391|NCT03718832|144690401|SUPERIORITY||Mean Difference (Net)|-1.101914|STANDARD_ERROR_OF_MEAN|1.860687||0.5542241|TWO_SIDED|95.0|-4.765783|2.561956||Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|Regression, Linear|||Adjusted mean difference for full controls, 12 months after trial enrollment||2.561956|-4.765783|0.5542241
72580392|NCT03718832|144690402|SUPERIORITY||Mean Difference (Net)|22.55812|STANDARD_ERROR_OF_MEAN|17.74244||0.2045348|TWO_SIDED|95.0|-12.35316|57.4694||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|t-test, 2 sided|||Unadjusted mean difference, 6 months after trial enrollment||57.4694|-12.35316|0.2045348
72580393|NCT03718832|144690402|SUPERIORITY||Mean Difference (Net)|13.49781|STANDARD_ERROR_OF_MEAN|14.95579||0.3675252|TWO_SIDED|95.0|-15.93658|42.9322||Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|Regression, Linear|||Adjusted mean difference for full controls, 6 months after trial enrollment||42.9322|-15.93658|0.3675252
72580394|NCT03718832|144690402|SUPERIORITY||Mean Difference (Net)|-11.35256|STANDARD_ERROR_OF_MEAN|26.69115||0.6709307|TWO_SIDED|95.0|-63.8992|41.19407||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|t-test, 2 sided|||Unadjusted mean difference, 12 months after trial enrollment||41.19407|-63.8992|0.6709307
72580395|NCT03718832|144690402|SUPERIORITY||Mean Difference (Net)|-8.912496|STANDARD_ERROR_OF_MEAN|21.34891||0.6766844|TWO_SIDED|95.0|-50.95358|33.12859||Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|Regression, Linear|||Adjusted mean difference for full controls, 12 months after trial enrollment||33.12859|-50.95358|0.6766844
72580396|NCT03718832|144690403|SUPERIORITY||Mean Difference (Net)|-1.870464|STANDARD_ERROR_OF_MEAN|2.024497||0.356123|TWO_SIDED|95.0|-5.851219|2.110291||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|t-test, 2 sided|||Unadjusted mean difference, 6 months after trial enrollment||2.110291|-5.851219|0.356123
72580397|NCT03718832|144690403|SUPERIORITY||Mean Difference (Net)|-0.8636408|STANDARD_ERROR_OF_MEAN|1.941141||0.6566494|TWO_SIDED|95.0|-4.681041|2.95376||Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|Regression, Linear|||Adjusted mean difference for full controls, 6 months after trial enrollment||2.95376|-4.681041|0.6566494
72580398|NCT03718832|144690403|SUPERIORITY||Mean Difference (Net)|-3.772051|STANDARD_ERROR_OF_MEAN|1.905125||0.0484944|TWO_SIDED|95.0|-7.519021|-0.0250809||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|t-test, 2 sided|||Unadjusted mean difference, 12 months after trial enrollment||-0.0250809|-7.519021|0.0484944
72580399|NCT03718832|144690403|SUPERIORITY||Mean Difference (Net)|-2.167034|STANDARD_ERROR_OF_MEAN|1.821244||0.234947|TWO_SIDED|95.0|-5.749627|1.415558||Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|Regression, Linear|||Adjusted mean difference for full controls, 12 months after trial enrollment||1.415558|-5.749627|0.234947
72580400|NCT03718832|144690404|SUPERIORITY||Mean Difference (Net)|-0.5561156|STANDARD_ERROR_OF_MEAN|1.086759||0.6091477|TWO_SIDED|95.0|-2.693002|1.58077||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|t-test, 2 sided|||Unadjusted mean difference, 6 months after trial enrollment||1.58077|-2.693002|0.6091477
72580401|NCT03718832|144690404|SUPERIORITY||Mean Difference (Net)|-0.3787962|STANDARD_ERROR_OF_MEAN|1.032547||0.713942|TWO_SIDED|95.0|-2.409379|1.651786||Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|Regression, Linear|||Adjusted mean difference for full controls, 6 months after trial enrollment||1.651786|-2.409379|0.713942
72580402|NCT03718832|144690404|SUPERIORITY||Mean Difference (Net)|0.4989275|STANDARD_ERROR_OF_MEAN|1.053869||0.6362064|TWO_SIDED|95.0|-1.573807|2.571662||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|t-test, 2 sided|||Unadjusted mean difference, 12 months after trial enrollment||2.571662|-1.573807|0.6362064
72580403|NCT03718832|144690404|SUPERIORITY||Mean Difference (Net)|1.146286|STANDARD_ERROR_OF_MEAN|1.048105||0.2748884|TWO_SIDED|95.0|-0.9154561|3.208027||Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|Regression, Linear|||Adjusted mean difference for full controls, 12 months after trial enrollment||3.208027|-0.9154561|0.2748884
72580404|NCT03718832|144690405|SUPERIORITY||Mean Difference (Net)|0.3232407|STANDARD_ERROR_OF_MEAN|0.3695066||0.3823224|TWO_SIDED|95.0|-0.4036366|1.050118||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|t-test, 2 sided|||Unadjusted mean difference, 6 months after trial enrollment||1.050118|-0.4036366|0.3823224
72580405|NCT03718832|144690405|SUPERIORITY||Mean Difference (Net)|0.2619965|STANDARD_ERROR_OF_MEAN|0.3729922||0.4829339|TWO_SIDED|95.0|-0.4718566|0.9958495||Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|Regression, Linear|||Adjusted mean difference for full controls, 6 months after trial enrollment||0.9958495|-0.4718566|0.4829339
72580406|NCT03718832|144690405|SUPERIORITY||Mean Difference (Net)|-0.6983982|STANDARD_ERROR_OF_MEAN|0.3476441||0.045506|TWO_SIDED|95.0|-1.382737|-0.0140597||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|t-test, 2 sided|||Unadjusted mean difference, 12 months after trial enrollment||-0.0140597|-1.382737|0.045506
72411927|NCT00795600|144331740|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|196.36|STANDARD_ERROR_OF_MEAN|498.7||0.696||95.0|-805.8|1198.5||H01: Micro detemir = micro NPH against the alternative H01: Microl detemir ≠ micro NPH.|ANCOVA|||The primary objective and endpoint of the trial was to compare the change in trunk fat mass (g) between insulin detemir versus insulin NPH at baseline and at week 26. A standard deviation of 5% was chosen based on a previous trial. A difference in trunk fat mass of 5% was considered clinically relevant also according to this trial.||1198.5|-805.8|0.696
72545996|NCT00094302|144621836|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.49|||<|0.01|TWO_SIDED|95.0|1.18|1.87||No covariate adjustment|Log Rank|Two-sided log rand test (0.05 Type 1 error)|Spironolactone compared to Placebo|"This endpoint was compared by trial arm (spironolactone vs. placebo) using a logrank test of time to first event from the time of randomization. Subjects who did not experience this endpoint were censored at the time of their last contact.~There were 295 subjects (175 in the Spironolactone group and 120 in the Placebo group) experiencing this endpoint. This endpoint did not undergo adjudication by the TOPCAT clinical endpoints committee."||1.87|1.18|<0.01
72545997|NCT00094302|144621837|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.94||||0.75|TWO_SIDED|95.0|0.66|1.35||No covariate adjustment|Log Rank|Two-sided log rank test (0.05 Type 1 error)|Spironolactone compared to Placebo|Composite endpoint was compared by trial arm using logrank test of time to first event from time of randomization. Time to event was the time at which the first observed event component of the composite endpoint was observed. Component endpoints were adjudicated by the TOPCAT clinical endpoints committee. There were 58 subjects in the Spironolactone group and 61 subjects in Placebo group with a confirmed event. Subjects who did not experience this endpoint were censored at time of last contact.||1.35|0.66|0.75
72552630|NCT02728102|144636050|SUPERIORITY|||||||0.303||||||Statistical significance was determined using a pre-specified threshold of 0.05|Log Rank|||The null hypothesis is that there is no difference of overall Survival between the lenalidomide/GM-CSF arm and lenalidomide alone arm.||||0.303
72552631|NCT02728102|144636052|SUPERIORITY|||||||0.189||||||Statistical significance was determined using a pre-specified threshold of 0.05|Chi-squared|||The null hypothesis is that there is no difference of proportions of patients With Grade ≥ 3 Toxicities between vaccine vs. non- vaccine arms.||||0.189
72552632|NCT02728102|144636054|SUPERIORITY|||||||0.82||||||Statistical significance was determined using a pre-specified threshold of 0.05|Gray's test for cumulative Incidence|||The null hypothesis is that there is no difference of Participants with Grade 2 and 3 infections between vaccine vs. non- vaccine arms.||||0.82
72552633|NCT02728102|144636055|SUPERIORITY|||||||0.21||||||Statistical significance was determined using a pre-specified threshold of 0.05|Gray's test for cumulative Incidence|||The null hypothesis is that there is no difference of Participants with Grade 2 and 3 infections between the vaccine arm and lenalidomide/GM-CSF arm.||||0.21
72411928|NCT00795600|144331741|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|192.81|STANDARD_ERROR_OF_MEAN|515.4||0.71||95.0|-844.0|1229.7||H01: Micro detemir = micro NPH against the alternative H01: Microl detemir ≠ micro NPH.|ANCOVA|||The primary objective and endpoint of the trial was to compare the change in trunk fat mass (g) between insulin detemir versus insulin NPH at baseline and at week 26. A standard deviation of 5% was chosen based on a previous trial. A difference in trunk fat mass of 5% was considered clinically relevant also according to this trial.||1229.7|-844.0|0.710
72545998|NCT00094302|144621838|SUPERIORITY_OR_OTHER|||||||0.27|TWO_SIDED||||||Regression, Linear|||A generalized linear model was fit, with the post-baseline quality of life scores as the dependent variable, and the baseline quality of life score, treatment group, month of visit, and the interaction between treatment group and month of visit as predictor variables. This tests whether the slope of the post-baseline quality of life parameter differs by treatment group, taking into account that measurements in the same subject over time may be correlated.||||0.27
72545999|NCT00094302|144621838|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||Regression, Linear|||Since the p-value for the preceding test (Statistical Analysis 1) was not significant at the 0.05 level, another generalized linear model was fit, omitting the interaction between treatment group and month of visit. This tests whether the value of the post-baseline quality of life parameter differs by treatment group, taking into account that measurements in the same subject over time may be correlated.||||<0.01
72546000|NCT00094302|144621839|SUPERIORITY_OR_OTHER|||||||0.87|TWO_SIDED||||||Regression, Linear|||A generalized linear model was fit, with the post-baseline quality of life scores as the dependent variable, and the baseline quality of life score, treatment group, month of visit, and the interaction between treatment group and month of visit as predictor variables. This tests whether the slope of the post-baseline quality of life parameter differs by treatment group, taking into account that measurements in the same subject over time may be correlated.||||0.87
72546001|NCT00094302|144621839|SUPERIORITY_OR_OTHER|||||||0.16|TWO_SIDED||||||Regression, Linear|||Since the p-value for the preceding test (Statistical Analysis 1) was not significant at the 0.05 level, another generalized linear model was fit, omitting the interaction between treatment group and month of visit. This tests whether the value of the post-baseline quality of life parameter differs by treatment group, taking into account that measurements in the same subject over time may be correlated.||||0.16
72546002|NCT00094302|144621840|SUPERIORITY_OR_OTHER|||||||0.99|TWO_SIDED||||||Regression, Linear|||A generalized linear model was fit, with the post-baseline quality of life scores as the dependent variable, and the baseline quality of life score and treatment group as predictor variables. This tests whether the value of the post-baseline quality of life parameter differs by treatment group.||||0.99
72546003|NCT00094302|144621841|SUPERIORITY_OR_OTHER|||||||0.39|TWO_SIDED||||||Regression, Linear|||A generalized linear model was fit, with the post-baseline quality of life scores as the dependent variable, and the baseline quality of life score, treatment group, month of visit, and the interaction between treatment group and month of visit as predictor variables. This tests whether the slope of the post-baseline quality of life parameter differs by treatment group, taking into account that measurements in the same subject over time may be correlated.||||0.39
72580407|NCT03718832|144690405|SUPERIORITY||Mean Difference (Net)|-0.6239824|STANDARD_ERROR_OF_MEAN|0.3336405||0.0625551|TWO_SIDED|95.0|-1.280906|0.0329412||Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|Regression, Linear|||Adjusted mean difference for full controls, 12 months after trial enrollment||0.0329412|-1.280906|0.0625551
72580408|NCT03718832|144690406|SUPERIORITY||Mean Difference (Net)|2.276579|STANDARD_ERROR_OF_MEAN|1.636162||0.1650343|TWO_SIDED|95.0|-0.9420086|5.495166||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|t-test, 2 sided|||Unadjusted mean difference, 6 months after trial enrollment||5.495166|-0.9420086|0.1650343
72580409|NCT03718832|144690406|SUPERIORITY||Mean Difference (Net)|1.989458|STANDARD_ERROR_OF_MEAN|1.359013||0.1442126|TWO_SIDED|95.0|-0.6843682|4.663284||Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|Regression, Linear|||Adjusted mean difference for full controls, 6 months after trial enrollment||4.663284|-0.6843682|0.1442126
72580410|NCT03718832|144690406|SUPERIORITY||Mean Difference (Net)|-1.579811|STANDARD_ERROR_OF_MEAN|0.739612||0.0335498|TWO_SIDED|95.0|-3.03574|-0.1238828||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|t-test, 2 sided|||Unadjusted mean difference, 12 months after trial enrollment.||-0.1238828|-3.03574|0.0335498
72580411|NCT03718832|144690406|SUPERIORITY||Mean Difference (Net)|-1.764632|STANDARD_ERROR_OF_MEAN|0.8545352||0.0398937|TWO_SIDED|95.0|-3.447175|-0.0820899||Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|Regression, Linear|||Adjusted mean difference for full controls, 12 months after trial enrollment||-0.0820899|-3.447175|0.0398937
72580412|NCT03718832|144690407|SUPERIORITY||Mean Difference (Net)|-0.6294078|STANDARD_ERROR_OF_MEAN|0.4409795||0.1544491|TWO_SIDED|95.0|-1.496923|0.238107||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|t-test, 2 sided|||Unadjusted mean difference, 6 months after trial enrollment||0.238107|-1.496923|0.1544491
72580413|NCT03718832|144690407|SUPERIORITY||Mean Difference (Net)|-0.6081765|STANDARD_ERROR_OF_MEAN|0.451915||0.1793486|TWO_SIDED|95.0|-1.497352|0.2809987||Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|Regression, Linear|||Adjusted mean difference for full controls, 6 months after trial enrollment||0.2809987|-1.497352|0.1793486
72580414|NCT03718832|144690407|SUPERIORITY||Mean Difference (Net)|-0.1731023|STANDARD_ERROR_OF_MEAN|0.4024787||0.6674618|TWO_SIDED|95.0|-0.9653829|0.6191784||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|t-test, 2 sided|||Unadjusted mean difference, 12 months after trial enrollment||0.6191784|-0.9653829|0.6674618
72411929|NCT00795600|144331742|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|288.21|STANDARD_ERROR_OF_MEAN|766.41||0.709||95.0|-1252.0|1828.4|||ANCOVA|||||1828.4|-1252.0|0.709
72580415|NCT03718832|144690407|SUPERIORITY||Mean Difference (Net)|-0.2208031|STANDARD_ERROR_OF_MEAN|0.4196435||0.5992113|TWO_SIDED|95.0|-1.047063|0.6054567||Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|Regression, Linear|||Adjusted mean difference for full controls, 12 months after trial enrollment||0.6054567|-1.047063|0.5992113
72411930|NCT00795600|144331743|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.178|STANDARD_ERROR_OF_MEAN|2.732||0.948||95.0|-5.668|5.313|||ANCOVA|||||5.313|-5.668|0.948
72411931|NCT00795600|144331744|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1151.0|STANDARD_ERROR_OF_MEAN|810.48||0.162||95.0|-2780.0|477.33|||ANCOVA|||||477.33|-2780.0|0.162
72411932|NCT00795600|144331745|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.747|STANDARD_ERROR_OF_MEAN|1.788||0.131||95.0|-6.34|0.846|||ANCOVA|||||0.846|-6.340|0.131
72411933|NCT00795600|144331746|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-110.4|STANDARD_ERROR_OF_MEAN|368.69||0.766||95.0|-851.3|630.51|||ANCOVA|||||630.51|-851.3|0.766
72411934|NCT00795600|144331747|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.61|STANDARD_ERROR_OF_MEAN|1.662||0.716||95.0|-3.949|2.729|||ANCOVA|||||2.729|-3.949|0.716
72411935|NCT00795600|144331748|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.491|STANDARD_ERROR_OF_MEAN|0.695||0.483||95.0|-0.906|1.888|||ANCOVA|||||1.888|-0.906|0.483
72411936|NCT00795600|144331749|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.116|STANDARD_ERROR_OF_MEAN|1.909||0.952||95.0|-3.721|3.953|||ANCOVA|||||3.953|-3.721|0.952
72411937|NCT00795600|144331750|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.278|STANDARD_ERROR_OF_MEAN|0.746||0.711||95.0|-1.778|1.221|||ANCOVA|||||1.221|-1.778|0.711
72411938|NCT00795600|144331751|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.585|STANDARD_ERROR_OF_MEAN|1.854||0.397||95.0|-5.31|2.141|||ANCOVA|||||2.141|-5.310|0.397
72411939|NCT00795600|144331752|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.916|STANDARD_ERROR_OF_MEAN|10.985||0.421||95.0|-30.99|13.159|||ANCOVA|||||13.159|-30.99|0.421
72411940|NCT00795600|144331753|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.061|STANDARD_ERROR_OF_MEAN|6.216||0.42||95.0|-17.55|7.43|||ANCOVA|||||7.430|-17.55|0.420
72411941|NCT00795600|144331754|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.961|STANDARD_ERROR_OF_MEAN|13.007||0.705||95.0|-31.1|21.178|||ANCOVA|||||21.178|-31.10|0.705
72411942|NCT00795600|144331755|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.59|STANDARD_ERROR_OF_MEAN|4.776||0.341||95.0|-14.19|5.007|||ANCOVA|||||5.007|-14.19|0.341
72411943|NCT00795600|144331756|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.004|STANDARD_ERROR_OF_MEAN|0.034||0.902||95.0|-0.064|0.073|||ANCOVA|||||0.073|-0.064|0.902
72411944|NCT00795600|144331757|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.789|STANDARD_ERROR_OF_MEAN|3.85||0.839||95.0|-8.525|6.947|||ANCOVA|||||6.947|-8.525|0.839
72411945|NCT00795600|144331758|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.021|STANDARD_ERROR_OF_MEAN|0.041||0.607||95.0|-0.105|0.062|||ANCOVA|||||0.062|-0.105|0.607
72411946|NCT00795600|144331759|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.777|STANDARD_ERROR_OF_MEAN|3.719||0.635||95.0|-9.254|5.7|||ANCOVA|||||5.700|-9.254|0.635
72411947|NCT00795600|144331760|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.13|STANDARD_ERROR_OF_MEAN|0.266||0.628||95.0|-0.663|0.403|||ANCOVA|||||0.403|-0.663|0.628
72411948|NCT00795600|144331761|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.92|STANDARD_ERROR_OF_MEAN|17.46||0.535||95.0|-46.03|24.182|||ANCOVA|||||24.182|-46.03|0.535
72411949|NCT00795600|144331762|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.918|STANDARD_ERROR_OF_MEAN|4.332||0.66||95.0|-10.65|6.813|||ANCOVA|||||6.813|-10.65|0.660
72411950|NCT00795600|144331789|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.629|STANDARD_ERROR_OF_MEAN|0.967||0.518||95.0|-2.572|1.313|||ANCOVA|||||1.313|-2.572|0.518
72411951|NCT00795600|144331790|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.546|STANDARD_ERROR_OF_MEAN|1.283||0.673||95.0|-3.123|2.032|||ANCOVA|||||2.032|-3.123|0.673
72411952|NCT00795600|144331791|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.466|STANDARD_ERROR_OF_MEAN|1.386||0.738||95.0|-2.319|3.25|||ANCOVA|||||3.250|-2.319|0.738
72411953|NCT00795600|144331792|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.062|STANDARD_ERROR_OF_MEAN|2.168||0.346||95.0|-2.3|6.423|||ANCOVA|||||6.423|-2.300|0.346
72411954|NCT00795600|144331793|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.726|STANDARD_ERROR_OF_MEAN|6.173||0.781||95.0|-10.71|14.167|||ANCOVA|||||14.167|-10.71|0.781
72411955|NCT00801684|144331832|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||The difference between the active treatment was compared to placebo. For a null hypothesis, the difference would equal 0 (zero).||||<0.0001
72411956|NCT04788147|144331860|OTHER|"The modified 3+3 design with 6 patients at the 'Recommended RefleXion FDG Dose level' aims to ensure that the observed proportion of patients below activity threshold to be less than 33%.~Probability of Observations at Most 1 of 6 below Activity Threshold True below activity rate 40% 30% 20% 10% Probability at most 1 of 6 patients below activity threshold 0.233 0.420 0.655 0.886"||||||||||||||||"Statistical analysis of the primary endpoint is not applicable to Cohort I. A modified 3+3 design was utilized wherein meeting the activity level threshold, not dose-limiting toxicity, is the endpoint. The RRFD is primarily based upon the lower FDG dose level where 5 to 6 out of 6 subjects have an Activity Concentration greater than 5 kBq/ml."|"Statistical analysis of the primary endpoint is not applicable to Cohort I. A modified 3+3 design was utilized wherein meeting the activity level threshold, not dose-limiting toxicity, is the endpoint. The RRFD is primarily based upon the lower FDG dose level where 5 to 6 out of 6 subjects have an Activity Concentration greater than 5 kBq/ml."|||
72411957|NCT05101252|144331872|SUPERIORITY|Superiority was declared if the upper limit of the 98.75% confidence interval of was below 0.00 logMAR for distance.|Least-square Mean|-0.08|STANDARD_ERROR_OF_MEAN|0.022|||TWO_SIDED|98.75|-0.14|-0.01|||Linear Mixed Model|Kenward and Roger method was used for denominator degrees of freedom.||It was calculated using a 2-sided one sample mean t-test with a family wise type I error rate of 5% (1.25% individually) with at least 90% statistical power, that 22 subjects were required to test for superiority for distance.||-0.01|-0.14|
72546004|NCT00094302|144621841|SUPERIORITY_OR_OTHER|||||||0.01|TWO_SIDED||||||Regression, Linear|||Since the p-value for the preceding test (Statistical Analysis 1) was not significant at the 0.05 level, another generalized linear model was fit, omitting the interaction between treatment group and month of visit. This tests whether the value of the post-baseline quality of life parameter differs by treatment group, taking into account that measurements in the same subject over time may be correlated.||||0.01
72546005|NCT00094302|144621842|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.94||||0.25|TWO_SIDED|95.0|0.85|1.04||No covariate adjustment|Log Rank|Two-sided log rand test (0.05 Type 1 error)|Spironolactone compared to Placebo|"This endpoint was compared by trial arm (spironolactone vs. placebo) using a logrank test of time to first event from the time of randomization. Subjects who did not experience this endpoint were censored at the time of their last contact.~There were a total of 1558 subjects (766 subjects in the Spironolactone group and 792 subjects in the Placebo) who were hospitalized for any cause while on study. This endpoint was not adjudicated by the TOPCAT clinical endpoints committee."||1.04|0.85|0.25
72546006|NCT00094302|144621843|SUPERIORITY_OR_OTHER|||||||0.27|TWO_SIDED||||||Regression, Linear|||A generalized linear model was fit, with the post-baseline laboratory value as the dependent variable, and the baseline laboratory value, treatment group, month of visit, and the interaction between treatment group and month of visit as predictor variables. This tests whether the slope of the post-baseline laboratory parameter differs by treatment group, taking into account that measurements in the same subject over time may be correlated.||||0.27
72546007|NCT00094302|144621843|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||Regression, Linear|||Since the p-value for the preceding test (Statistical Analysis 1) was not significant at the 0.05 level, another generalized linear model was fit, omitting the interaction between treatment group and month of visit. This tests whether the value of the post-baseline laboratory parameter differs by treatment group, taking into account that measurements in the same subject over time may be correlated.||||<0.01
72580416|NCT03718832|144690408|SUPERIORITY||Mean Difference (Net)|0.4824561|STANDARD_ERROR_OF_MEAN|0.423027||0.2549037|TWO_SIDED|95.0|-0.349686|1.314598||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|t-test, 2 sided|||Unadjusted mean difference, 6 months after trial enrollment||1.314598|-0.349686|0.2549037
72580417|NCT03718832|144690408|SUPERIORITY||Mean Difference (Net)|0.3545817|STANDARD_ERROR_OF_MEAN|0.4230741||0.4025977|TWO_SIDED|95.0|-0.4777863|1.186949||Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|Regression, Linear|||Adjusted mean difference for full controls, 6 months after trial enrollment||1.186949|-0.4777863|0.4025977
72580418|NCT03718832|144690408|SUPERIORITY||Mean Difference (Net)|-0.0102657|STANDARD_ERROR_OF_MEAN|0.4695747||0.9825739|TWO_SIDED|95.0|-0.9346107|0.9140792||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|t-test, 2 sided|||Unadjusted mean difference, 12 months after trial enrollment||0.9140792|-0.9346107|0.9825739
72580419|NCT03718832|144690408|SUPERIORITY||Mean Difference (Net)|-0.0340184|STANDARD_ERROR_OF_MEAN|0.4869778||0.9443607|TWO_SIDED|95.0|-0.9928399|0.9248032||Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|Regression, Linear|||Adjusted mean difference for full controls, 12 months after trial enrollment||0.9248032|-0.9928399|0.9443607
72580420|NCT03718832|144690409|SUPERIORITY||Mean Difference (Net)|0.160997|STANDARD_ERROR_OF_MEAN|0.0376773||2.52e-05|TWO_SIDED|95.0|0.0868814|0.2351126||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|t-test, 2 sided|||Unadjusted mean difference, 6 months after trial enrollment||0.2351126|0.0868814|0.0000252
72580421|NCT03718832|144690409|SUPERIORITY||Mean Difference (Net)|0.1691707|STANDARD_ERROR_OF_MEAN|0.0391132||2.04e-05|TWO_SIDED|95.0|0.0922183|0.2461232||Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|Regression, Linear|||Adjusted mean difference for full controls, 6 months after trial enrollment||0.2461232|0.0922183|0.0000204
72580422|NCT03718832|144690409|SUPERIORITY||Mean Difference (Net)|0.0028595|STANDARD_ERROR_OF_MEAN|0.0261733||0.9130816|TWO_SIDED|95.0|-0.0486635|0.0543825||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|t-test, 2 sided|||Unadjusted mean difference, 12 months after trial enrollment||0.0543825|-0.0486635|0.9130816
72580423|NCT03718832|144690409|SUPERIORITY||Mean Difference (Net)|0.0166325|STANDARD_ERROR_OF_MEAN|0.0271062||0.5400053|TWO_SIDED|95.0|-0.0367394|0.0700045||Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|Regression, Linear|||Adjusted mean difference for full controls, 12 months after trial enrollment||0.0700045|-0.0367394|0.5400053
72580424|NCT03718832|144690410|SUPERIORITY||Mean Difference (Net)|0.0511555|STANDARD_ERROR_OF_MEAN|0.016316||0.0018721|TWO_SIDED|95.0|0.0190582|0.0832528||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|t-test, 2 sided|||Unadjusted mean difference, 6 months after trial enrollment||0.0832528|0.0190582|0.0018721
72580425|NCT03718832|144690410|SUPERIORITY||Mean Difference (Net)|0.0433081|STANDARD_ERROR_OF_MEAN|0.0168497||0.0106231|TWO_SIDED|95.0|0.0101555|0.0764607||Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|Regression, Linear|||Adjusted mean difference for full controls, 6 months after trial enrollment||0.0764607|0.0101555|0.0106231
72580426|NCT03718832|144690410|SUPERIORITY||Mean Difference (Net)|0.0138256|STANDARD_ERROR_OF_MEAN|0.0171112||0.4197898|TWO_SIDED|95.0|-0.0198584|0.0475096||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|t-test, 2 sided|||Unadjusted mean difference, 12 months after trial enrollment||0.0475096|-0.0198584|0.4197898
72580427|NCT03718832|144690410|SUPERIORITY||Mean Difference (Net)|0.0179852|STANDARD_ERROR_OF_MEAN|0.0171811||0.2961479|TWO_SIDED|95.0|-0.0158442|0.0518147||Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|Regression, Linear|||Adjusted mean difference for full controls, 12 months after trial enrollment||0.0518147|-0.0158442|0.2961479
72411958|NCT05101252|144331872|SUPERIORITY|Superiority was declared if the upper limit of the 98.75% confidence interval of was below 0.17 logMAR for intermediate.|Least-square Mean|0.0|STANDARD_ERROR_OF_MEAN|0.022|||TWO_SIDED|98.75|-0.06|0.07|||Linear Mixed Model|Kenward and Roger method was used for denominator degrees of freedom.||It was calculated using a 2-sided one sample mean t-test with a family wise type I error rate of 5% (1.25% individually) with at least 90% statistical power, that 12 subjects were required to test for superiority for intermediate.||0.07|-0.06|
72411959|NCT05101252|144331872|SUPERIORITY|Superiority was declared if the upper limit of the 98.75% confidence interval of was below 0.17 logMAR for near.|Least-square Mean|0.09|STANDARD_ERROR_OF_MEAN|0.023|||TWO_SIDED|98.75|0.02|0.16|||Linear Mixed Model|Kenward and Roger method was used for denominator degrees of freedom.||It was calculated using a 2-sided one sample mean t-test with a family wise type I error rate of 5% (1.25% individually) with at least 90% statistical power, that 60 subjects were required to test for superiority for near.||0.16|0.02|
72411960|NCT05101252|144331873|SUPERIORITY|Superiority was declared if the lower bound of the 98.75% confidence interval was above 32.|Least-square Mean|50.8|STANDARD_ERROR_OF_MEAN|2.922|||TWO_SIDED|98.75|43.1|58.5|||Linear Mixed Model|Kenward and Roger method was used for denominator degrees of freedom.||It was calculated using a 2-sided one sample mean t-test with a family wise type I error rate of 5% (1.25% individually) with at least 99% statistical power, that 13 subjects were required to test for superiority for CLUE vision scores.||58.5|43.1|
72552634|NCT02728102|144636055|SUPERIORITY|||||||0.4||||||Statistical significance was determined using a pre-specified threshold of 0.05|Gray's test for cumulative Incidence|||The null hypothesis is that there is no difference of Participants with Grade 2 and 3 infections between the vaccine arm and lenalidomide alone arm.||||0.40
72552635|NCT02728102|144636055|SUPERIORITY|||||||0.08||||||Statistical significance was determined using a pre-specified threshold of 0.05|Gray's test for cumulative Incidence|||The null hypothesis is that there is no difference of Participants with Grade 2 and 3 infections between the lenalidomide/GM-CSF arm and lenalidomide alone arm.||||0.08
72552636|NCT02728102|144636056|SUPERIORITY|||||||0.8||||||Statistical significance was determined using a pre-specified threshold of 0.05.|Chi-squared|||The null hypothesis is that there is no difference of proportions of patients without Minimal Residual Disease between vaccine vs. non- vaccine arms||||0.80
72552637|NCT00234286|144636086|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.39||||0.009|TWO_SIDED|95.0|1.09|1.76|||Generalized Estimating Equation|||||1.76|1.09|.009
72552638|NCT00234286|144636087|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.36||||0.09|TWO_SIDED|95.0|0.95|1.96|||Generalized Estimating Equation|||||1.96|0.95|0.09
72552639|NCT00234286|144636088|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.92||||0.69|TWO_SIDED|95.0|0.59|1.42|||Generalized Estimating Equation|||||1.42|0.59|0.69
72552640|NCT00234286|144636089|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.71||||0.03|TWO_SIDED|95.0|0.53|0.96|||Generalized Estimating Equations|||||0.96|0.53|.03
72546008|NCT00094302|144621844|SUPERIORITY_OR_OTHER|||||||0.53|TWO_SIDED||||||Regression, Linear|||A generalized linear model was fit, with the post-baseline laboratory value as the dependent variable, and the baseline laboratory value, treatment group, month of visit, and the interaction between treatment group and month of visit as predictor variables. This tests whether the slope of the post-baseline laboratory parameter differs by treatment group, taking into account that measurements in the same subject over time may be correlated.||||0.53
72552641|NCT00234286|144636090|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.66||||0.15|TWO_SIDED|95.0|0.38|1.16|||Generalized Estimating Equation|||||1.16|0.38|0.15
72552642|NCT00234286|144636091|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.04||||0.86|TWO_SIDED|95.0|0.67|1.62|||Generalized Estimating Equation|||||1.62|0.67|0.86
72552643|NCT00234286|144636092|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.36||||0.09|TWO_SIDED|95.0|0.95|1.96|||Generalized Estimating Equation|||||1.96|0.95|0.09
72411961|NCT05101252|144331874|NON_INFERIORITY|Non-inferiority was declared if the upper limit of the 95% confidence interval of the least-square mean difference was below 0.05 logMAR.|LSM Difference|0.0|STANDARD_ERROR_OF_MEAN|0.024|||TWO_SIDED|95.0|-0.05|0.05|||Linear Mixed Model|Kenward and Roger method was used for denominator degrees of freedom.|LSM difference was calculated as Test minus Control|It was calculated using a 2 independent sample means t-test with a 2-sided type I error rate of 5% with at least 95% statistical power, that 60 subjects were required to test for non-inferiority of the Test compared to the Control for distance (4m).||0.05|-0.05|
72411962|NCT02401672|144331879|SUPERIORITY|||||||0.05|||||||Mixed Models Analysis|||||||0.05
72411963|NCT02401672|144331880|SUPERIORITY|||||||0.05|||||||t-test, 2 sided|||||||0.05
72546009|NCT00094302|144621844|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||Regression, Linear|||Since the p-value for the preceding test (Statistical Analysis 1) was not significant at the 0.05 level, another generalized linear model was fit, omitting the interaction between treatment group and month of visit. This tests whether the value of the post-baseline laboratory parameter differs by treatment group, taking into account that measurements in the same subject over time may be correlated.||||<0.01
72546010|NCT00094302|144621845|SUPERIORITY_OR_OTHER|||||||0.11|TWO_SIDED||||||Regression, Linear|||A generalized linear model was fit, with the post-baseline laboratory value as the dependent variable, and the baseline laboratory value, treatment group, month of visit, and the interaction between treatment group and month of visit as predictor variables. This tests whether the slope of the post-baseline laboratory parameter differs by treatment group, taking into account that measurements in the same subject over time may be correlated.||||0.11
72546011|NCT00094302|144621845|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||Regression, Linear|||Since the p-value for the preceding test (Statistical Analysis 1) was not significant at the 0.05 level, another generalized linear model was fit, omitting the interaction between treatment group and month of visit. This tests whether the value of the post-baseline laboratory parameter differs by treatment group, taking into account that measurements in the same subject over time may be correlated.||||<0.01
72546012|NCT00094302|144621846|SUPERIORITY_OR_OTHER|||||||0.59|TWO_SIDED||||||Regression, Linear|||A generalized linear model was fit, with the post-baseline laboratory value as the dependent variable, and the baseline laboratory value, treatment group, month of visit, and the interaction between treatment group and month of visit as predictor variables. This tests whether the slope of the post-baseline laboratory parameter differs by treatment group, taking into account that measurements in the same subject over time may be correlated.||||0.59
72546013|NCT00094302|144621846|SUPERIORITY_OR_OTHER|||||||0.54|TWO_SIDED||||||Regression, Linear|||Since the p-value for the preceding test (Statistical Analysis 1) was not significant at the 0.05 level, another generalized linear model was fit, omitting the interaction between treatment group and month of visit. This tests whether the value of the post-baseline laboratory parameter differs by treatment group, taking into account that measurements in the same subject over time may be correlated.||||0.54
72546014|NCT00094302|144621847|SUPERIORITY_OR_OTHER|||||||0.98|TWO_SIDED||||||Regression, Linear|||A generalized linear model was fit, with the post-baseline laboratory value as the dependent variable, and the baseline laboratory value, treatment group, month of visit, and the interaction between treatment group and month of visit as predictor variables. This tests whether the slope of the post-baseline laboratory parameter differs by treatment group, taking into account that measurements in the same subject over time may be correlated.||||0.98
72546015|NCT00094302|144621847|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED||||||Regression, Linear|||Since the p-value for the preceding test (Statistical Analysis 1) was not significant at the 0.05 level, another generalized linear model was fit, omitting the interaction between treatment group and month of visit. This tests whether the value of the post-baseline laboratory parameter differs by treatment group, taking into account that measurements in the same subject over time may be correlated.||||0.02
72546016|NCT00006170|144621848|NON_INFERIORITY_OR_EQUIVALENCE|Power was determined using a log-rank statistic for comparing 2 survival curves, with a 2-sided alpha level of 0.05 and 40% as the reference from which differences were computed.||||||0.001|TWO_SIDED|95.0|||||Regression, Logistic|||||||0.001
72546017|NCT00006170|144621848|NON_INFERIORITY_OR_EQUIVALENCE|Power was determined using a log-rank statistic for comparing 2 survival curves, with a 2-sided alpha level of 0.05 and 40% as the reference from which differences were computed.||||||0.25||95.0|||||Regression, Logistic|||||||0.25
72546018|NCT00006170|144621848|NON_INFERIORITY_OR_EQUIVALENCE|Power was determined using a log-rank statistic for comparing 2 survival curves, with a 2-sided alpha level of 0.05 and 40% as the reference from which differences were computed.||||||0.07||95.0|||||Regression, Logistic|||||||0.07
72546019|NCT00006170|144621849|NON_INFERIORITY_OR_EQUIVALENCE|Power was determined using a log-rank statistic for comparing 2 survival curves, with a 2-sided alpha level of 0.05 and 40% as the reference from which differences were computed.|||||<|0.001||95.0|||||Regression, Logistic|||||||<0.001
72411964|NCT02401672|144331881|SUPERIORITY|||||||0.05|||||||Mixed Models Analysis|||||||0.05
72411965|NCT02401672|144331882|SUPERIORITY|||||||0.05|||||||Chi-squared|||||||0.05
72546020|NCT00006170|144621849|NON_INFERIORITY_OR_EQUIVALENCE|Power was determined using a log-rank statistic for comparing 2 survival curves, with a 2-sided alpha level of 0.05 and 40% as the reference from which differences were computed.||||||0.053||95.0|||||Regression, Logistic|||||||0.053
72546021|NCT00006170|144621849|NON_INFERIORITY_OR_EQUIVALENCE|Power was determined using a log-rank statistic for comparing 2 survival curves, with a 2-sided alpha level of 0.05 and 40% as the reference from which differences were computed.||||||0.08||95.0|||||Regression, Logistic|||||||0.08
72552644|NCT00234286|144636093|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.98||||0.01|TWO_SIDED|95.0|1.17|3.36|||Generalized Estimating Equation|||||3.36|1.17|0.01
72552645|NCT00234286|144636094|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.31||||0.36|TWO_SIDED|95.0|0.73|2.35|||Generalized Estimating Equation|||||2.35|0.73|0.36
72552646|NCT00234286|144636095|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.39||||0.01|TWO_SIDED|95.0|1.08|1.77|||Generalized Estimating Equation|||||1.77|1.08|0.01
72411966|NCT03321019|144331914|OTHER||F-statistic|8.59|||<|0.0001|TWO_SIDED|||||The p value was adjusted for multiple comparisons using Tukey's method.|ANOVA|Degree of freedom - 3, 278||Healthy controls were compared to PD participants across each of the 3 visits. PD participants were compared between visits 1, 2 and 3.||||<.0001
72552647|NCT00234286|144636096|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.95||||0.76|TWO_SIDED|95.0|0.7|1.3|||Generalized Estimating Equation|||||1.30|0.70|0.76
72552648|NCT00234286|144636097|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.77||||0.004|TWO_SIDED|95.0|1.41|5.44|||Generalized Estimating Equation|||||5.44|1.41|.004
72552649|NCT00234286|144636098|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.12||||0.007|TWO_SIDED|95.0|1.51|11.28|||Generalized Estimating Equations|||||11.28|1.51|0.007
72552650|NCT00234286|144636099|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.64||||0.14|TWO_SIDED|95.0|0.84|3.2|||Generalized Estimating Equations|||||3.20|0.84|0.14
72552651|NCT00234286|144636100|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.47||||0.003|TWO_SIDED|95.0|1.15|1.88|||Generalized Estimating Equation|||||1.88|1.15|.003
72546022|NCT00006170|144621850|NON_INFERIORITY_OR_EQUIVALENCE|Power was determined using a log-rank statistic for comparing 2 survival curves, with a 2-sided alpha level of 0.05 and 40% as the reference from which differences were computed.||||||0.006||95.0|||||Regression, Logistic|||||||0.006
72546023|NCT00006170|144621850|NON_INFERIORITY_OR_EQUIVALENCE|Power was determined using a log-rank statistic for comparing 2 survival curves, with a 2-sided alpha level of 0.05 and 40% as the reference from which differences were computed.||||||0.45||95.0|||||Regression, Logistic|||||||0.45
72546024|NCT00006170|144621850|NON_INFERIORITY_OR_EQUIVALENCE|Power was determined using a log-rank statistic for comparing 2 survival curves, with a 2-sided alpha level of 0.05 and 40% as the reference from which differences were computed.||||||0.046||95.0|||||Regression, Logistic|||||||0.046
72546025|NCT02058628|144621851|SUPERIORITY_OR_OTHER|||||||0.0004||95.0||||Data is represented as per CTR.|Wilcoxon (Mann-Whitney)|DUAC versus SKINOREN with a nominal alpha level of 5%, without adjustment for multiple comparisons.||||||0.0004
72546026|NCT04527471|144621904|OTHER|||||||1|TWO_SIDED|95.0|||||Fisher Exact|||||||1
72546027|NCT00096265|144621950|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.43||||0.93|TWO_SIDED|95.0|0.89|2.31||One-sided|Log Rank||WBRT + SRS is the denominator of the hazard ratio.|120 patients per arm required to detect a 33% reduction in hazard rate corresponding to improvement in MST of 5.9 (null hypothesis) to 8.9 months with a one-sided type I error rate of 0.025 and 85% power.||2.31|0.89|0.93
72546028|NCT00096265|144621950|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.47||||0.95|TWO_SIDED|95.0|0.92|2.36||One-sided|Log Rank||WBRT + SRS is the denominator of the hazard ratio.|120 patients per arm required to detect a 33% reduction in hazard rate corresponding to improvement in MST of 5.9 (null hypothesis) to 8.9 months with a one-sided type I error rate of 0.025 and 85% power.||2.36|0.92|0.95
72546029|NCT00096265|144621951|SUPERIORITY|||||||0.3|||||||Gray's test|||||||0.30
72546030|NCT00096265|144621951|SUPERIORITY|||||||0.48|||||||Gray's test|||||||0.48
72546031|NCT00096265|144621953|SUPERIORITY|||||||0.39|||||||Chi-squared|||With 70 patients per arm, a 0.05 level chi-square test would have 80% power to distinguish between two groups when the proportions in the three categories are as follows for standard vs. experimental arm, respectively: 25% vs. 50% improvement, 55% vs. 40% stable, and 20% vs. 10% deterioration, or any distribution that corresponds to an effect size, Δ² = Σ(π2j-π1j)2/\[2(π2j-π1j)\], of 0.0702.||||0.39
72546032|NCT00096265|144621953|SUPERIORITY|||||||0.28|||||||Chi-squared|||With 70 patients per arm, a 0.05 level chi-square test would have 80% power to distinguish between two groups when the proportions in the three categories are as follows for standard vs. experimental arm, respectively: 25% vs. 50% improvement, 55% vs. 40% stable, and 20% vs. 10% deterioration, or any distribution that corresponds to an effect size, Δ² = Σ(π2j-π1j)2/\[2(π2j-π1j)\], of 0.0702.||||0.28
72546033|NCT00096265|144621954|SUPERIORITY|||||||0.002|||||||Chi-squared|||108 with three month performance status data, per arm, would result in a 0.050 level chi-square test with 90% power to distinguish between the groups when the proportions in the 3 categories are characterized by an effect size, Δ² = Σ(π2j-π1j)2/\[2(π2j-π1j)\], of 0.0586.||||0.002
72546034|NCT00096265|144621954|SUPERIORITY||||||<|0.001|||||||Chi-squared|||108 cases with three month performance status data, per arm, would result in a 0.050 level chi-square test with 90% power to distinguish between the groups when the proportions in the 3 categories are characterized by an effect size, Δ² = Σ(π2j-π1j)2/\[2(π2j-π1j)\], of 0.0586.||||< 0.001
72546035|NCT00096265|144621955|SUPERIORITY|Assuming the survival rate of the standard arm (MST = 5.9 months), then 49% of patients were expected to be alive at six months. Assuming steroid data would be available for 90% of these patients, results in a projection of 52 cases/arm with steroid data at 6 months. With this sample size, a two-sided 0.050 alpha test will have 90% power to distinguish between the groups when the proportions in the 3 categories are characterized by an effect size, Δ² = Σ(π2j-π1j)2/\[2(π2j-π1j)\], of 0.1217.||||||0.51|||||||Chi-squared|||||||0.51
72546036|NCT00096265|144621955|SUPERIORITY|||||||0.56|||||||Chi-squared|||Assuming the survival rate of the standard arm (MST = 5.9 months), then 49% of patients were expected to be alive at six months. Assuming steroid data would be available for 90% of these patients, results in a projection of 52 cases/arm with steroid data at 6 months. With this sample size, a two-sided 0.050 alpha test will have 90% power to distinguish between the groups when the proportions in the 3 categories are characterized by an effect size, Δ² = Σ(π2j-π1j)2/\[2(π2j-π1j)\], of 0.1217.||||0.56
72546037|NCT00096265|144621956|SUPERIORITY|||||||0.78|||||||Chi-squared|||A two group chi-square test with a 0.05 two-sided significance level would have 89% power to detect the difference between a proportion of 0.50 and a proportion of 0.30, or equivalently, of 0.70, when the sample size in each group is 120.||||0.78
72546038|NCT00096265|144621956|SUPERIORITY|||||||0.8|||||||Chi-squared|||A two group chi-square test with a 0.05 two-sided significance level would have 89% power to detect the difference between a proportion of 0.50 and a proportion of 0.30, or equivalently, of 0.70, when the sample size in each group is 120.||||0.80
72546039|NCT01506323|144621957|SUPERIORITY_OR_OTHER||||||<|0.006|TWO_SIDED|||||This p-value is based on a false discovery rate adjustment for multiple hypothesis testing.|Mixed Models Analysis|Mixed-effects, repeated measures models adjusting for demographic factors were implemented.||This analysis is from baseline (week 0) to post-treatment (week 8). Cronbach's alpha for this study was .92 at baseline.||||<.006
72546040|NCT01506323|144621957|SUPERIORITY_OR_OTHER||repeated measures||||<|0.031|TWO_SIDED|||||The p-value was adjusted for multiple comparisons using false discovery rate.|Mixed Models Analysis|This p-value is based on a false discovery rate adjustment for multiple hypothesis testing.||This analysis is from baseline (week 0) to 2 months follow-up.||||<.031
72546041|NCT01506323|144621958|SUPERIORITY_OR_OTHER|||||||0.82|TWO_SIDED|||||The p-value is based on false discovery rate adjustment for multiple comparisons.|Mixed Models Analysis|||This analysis is from baseline to post-treatment. Cronbach's alpha for this study was .86 at baseline.||||0.82
72546042|NCT01506323|144621958|SUPERIORITY_OR_OTHER|||||||0.82|ONE_SIDED|||||This p-value is based on a false discovery rate adjustment for multiple hypothesis testing.|Mixed Models Analysis|||This analysis is from baseline to 2 months post-treatment.||||0.82
72546043|NCT01506323|144621959|SUPERIORITY_OR_OTHER||||||<|0.008|TWO_SIDED|||||This p-value is based on a false discovery rate adjustment for multiple hypothesis testing.|repeated measures|||This analysis is from baseline to post-treatment. Cronbach's alpha for this study was .85 at baseline.||||<0.008
72411967|NCT03321019|144331915|OTHER||F-statistic|0.44||||0.72|TWO_SIDED|||||Tukey's method was used to control for multiple comparisons.|ANOVA|Degrees of freedom - 3. 278||Healthy controls were compared to PD participants across each of the 3 visits. PD participants were compared between visits 1, 2 and 3.||||0.72
72411968|NCT03321019|144331916|OTHER||F-statistic|3.048||||0.02|TWO_SIDED|||||Dunnett's T3 method was used to account for multiple comparisons.|ANOVA|degrees of freedom: 3, 229||Healthy controls were compared to PD participants across each of the 3 visits. PD participants were compared between visits 1, 2 and 3.||||0.02
72411969|NCT03321019|144331917|OTHER||F-statistic|2.939||||0.034|TWO_SIDED|||||The p value was adjusted in the analysis for multiple comparisons using Tukey's method.|ANOVA|Degrees of freedom - 3, 231||Healthy controls were compared to PD participants across each of the 3 visits. PD participants were compared between visits 1, 2 and 3.||||0.034
72411970|NCT03321019|144331918|OTHER||F-statistic|1.494||||0.022|TWO_SIDED|||||Tukey's method was used to adjust for multiple comparisons.|ANOVA|Degrees of freedom - 3, 274||Healthy controls were compared to PD participants across each of the 3 visits. PD participants were compared between visits 1, 2 and 3.||||0.022
72411971|NCT04289753|144331961|SUPERIORITY||Odds Ratio (OR)|0.56|||||TWO_SIDED|95.0|0.46|0.69||||||||0.69|0.46|
72411972|NCT04289753|144331962|SUPERIORITY||Odds Ratio (OR)|0.69|||||TWO_SIDED|95.0|0.55|0.85||||||||0.85|0.55|
72411973|NCT04289753|144331963|SUPERIORITY||Odds Ratio (OR)|0.85|||||TWO_SIDED|95.0|0.7|1.0||||||||1.0|0.70|
72411974|NCT03238001|144331999|NON_INFERIORITY|In order to show non-inferiority, a lower 90% confidence limit (CL) for the difference in kappa scores would need to be greater than or equal to -0.20. The 90% confidence interval was calculated based on 5000 bootstrapped differences in kappa scores.|Lower 90% CL for difference in Kappas|-0.12|||||TWO_SIDED|90.0|-0.12|0.05|||||90% CI for Kappa of DCTclock/MoCA - Kappa of MMSE/MoCA (estimated with bootstrap method using 5000 bootstraps).|A two-one-sided tests approach was taken, where, prior to analysis, it was determined that a delta (equivalence margin) of 0.20 would be considered a significant difference between the DCTclock/MoCA kappa and the MMSE/MoCA kappa. The reasoning behind this determination can be found in the study's statistical analysis plan.||0.05|-0.12|
72580428|NCT03718832|144690411|SUPERIORITY||Mean Difference (Net)|0.4018522|STANDARD_ERROR_OF_MEAN|0.1001575||7.43e-05|TWO_SIDED|95.0|0.2048311|0.5988733||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|t-test, 2 sided|||Unadjusted mean difference, 6 months after trial enrollment||0.5988733|0.2048311|0.0000743
72580429|NCT03718832|144690411|SUPERIORITY||Mean Difference (Net)|0.3643095|STANDARD_ERROR_OF_MEAN|0.1026922||0.0004471|TWO_SIDED|95.0|0.16227|0.566349||Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|Regression, Linear|||Adjusted mean difference for full controls, 6 months after trial enrollment||0.566349|0.16227|0.0004471
72411975|NCT01827904|144332021|SUPERIORITY|Percent change from Baseline at the 3 Month visit in the Exablate test vs. Sham control arms was tested using the t-test.|||||<|0.001|||||||t-test, 1 sided|alpha = 0.05 for the hypothesis test. H0: M3ExAblate ≤ M3Sham H1: M3ExAblate \> M3Sham||"Note that the Crossover group was a rescue treatment group and not integral to the experimental design statistical analysis."||||<0.001
72411976|NCT02207829|144332033|NON_INFERIORITY_OR_EQUIVALENCE|Alternate hypothesis: the difference between the trt means (umeclidinium minus tiotropium) would be \> -50 milliliters (mL). If the lower CI (2.5% 1-sided significance level) of the statistical test should fall above -50 mL, then umeclidinium may be deemed statistically non-inferior to tiotropium. If the lower CI (2.5% 1-sided significance) of the statistical testing exceeded 0 then, umeclidinium may be deemed statistically superior to tiotropium.|Mean Difference (Final Values)|0.059|||<|0.001|TWO_SIDED|95.0|0.029|0.088|||Mixed Models Analysis|||||0.088|0.029|<0.001
72411977|NCT01344460|144332044|SUPERIORITY_OR_OTHER||Percentage difference|18.3|||<|0|TWO_SIDED|95.0|15.2||Not Appropriate, upper intervals were not used in the statistical analysis and were not of interest for the study.||McNemar|Cluster adjusted McNemar||Majority reader; Superiority analysis; The percentage difference was calculated as gadobutrol-enhanced minus unenhanced MRA.|||15.2|<0.000
72411978|NCT01344460|144332044|SUPERIORITY_OR_OTHER||Percentage difference|16.4|||<|0|TWO_SIDED|95.0|13.2||Not Appropriate, upper intervals were not used in the statistical analysis and were not of interest for the study.||McNemar|Cluster adjusted McNemar||Blinded reader 1; Superiority analysis; The percentage difference was calculated as gadobutrol-enhanced minus unenhanced MRA.|||13.2|<0.000
72411979|NCT01344460|144332044|SUPERIORITY_OR_OTHER||Percentage difference|24.0|||<|0|TWO_SIDED|95.0|20.5||Not Appropriate, upper intervals were not used in the statistical analysis and were not of interest for the study.||McNemar|Cluster adjusted McNemar||Blinded reader 2; Superiority analysis; The percentage difference was calculated as gadobutrol-enhanced minus unenhanced MRA.|||20.5|<0.000
72546044|NCT01506323|144621959|SUPERIORITY_OR_OTHER||||||<|0.09|TWO_SIDED|||||This p-value is based on a false discovery rate adjustment for multiple hypothesis testing.|Mixed Models Analysis|||This analysis is from baseline to 2 months post-treatment||||<0.09
72546045|NCT01506323|144621960|SUPERIORITY_OR_OTHER||||||<|0.006|TWO_SIDED|||||This p-value is based on a false discovery rate adjustment for multiple hypothesis testing.|Mixed Models Analysis|||This analysis is from baseline to post-treatment. Cronbach's alpha for this study was .78 at baseline.||||<.006
72546046|NCT01506323|144621960|SUPERIORITY_OR_OTHER||||||<|0.03|TWO_SIDED|||||This p-value is based on a false discovery rate adjustment for multiple hypothesis testing.|repeated measures|||This analysis is from baseline to 2 months post-treatment.||||<.03
72546047|NCT01506323|144621961|SUPERIORITY_OR_OTHER||||||<|0.0008|TWO_SIDED|||||This p-value is based on a false discovery rate adjustment for multiple hypothesis testing.|repeated measures|||This analysis is from baseline to post-treatment. Cronbach's alpha for this study was .89 at baseline.||||<0.0008
72546048|NCT01506323|144621961|SUPERIORITY_OR_OTHER||||||<|0.006|TWO_SIDED|||||This p-value is based on a false discovery rate adjustment for multiple hypothesis testing.|Wilcoxon (Mann-Whitney)|||This analysis is from baseline to 2 months post-treatment.||||<0.006
72546049|NCT01506323|144621962|SUPERIORITY_OR_OTHER||||||<|0.1|TWO_SIDED|||||This p-value is based on a false discovery rate adjustment for multiple hypothesis testing. Raw p-value was \<0.02.|Mixed Models Analysis|||This analysis is from baseline to post-treatment. Cronbach's alpha for total score in this study was .86 at baseline.||||<0.10
72546050|NCT01506323|144621962|SUPERIORITY_OR_OTHER||||||<|0.49|TWO_SIDED|||||This p-value is based on a false discovery rate adjustment for multiple hypothesis testing.|Mixed Models Analysis|||This analysis is from baseline to post-treatment.||||<0.49
72546051|NCT01506323|144621963|SUPERIORITY_OR_OTHER||||||<|0.78|TWO_SIDED|||||This p-value is based on a false discovery rate adjustment for multiple hypothesis testing.|Mixed Models Analysis|||This analysis is from baseline to post-treatment. Cronbach's alpha for this study was .96 at baseline.||||<0.78
72546052|NCT01506323|144621963|SUPERIORITY_OR_OTHER||||||<|0.99|TWO_SIDED|||||This p-value is based on a false discovery rate adjustment for multiple hypothesis testing.|Mixed Models Analysis|||This analysis is from baseline to 2-months post-treatment.||||<0.99
72552652|NCT00234286|144636101|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.45||||0.19|TWO_SIDED|95.0|0.62|9.7|||Generalized Estimation Equations|||||9.70|0.62|0.19
72546053|NCT01506323|144621964|SUPERIORITY_OR_OTHER||||||<|0.04|TWO_SIDED|||||This p-value is based on a false discovery rate adjustment for multiple hypothesis testing.|Mixed Models Analysis|||This analysis was from baseline to post-treatment. Cronbach's alpha for this study was .92 at baseline.||||<0.04
72546054|NCT01506323|144621964|SUPERIORITY_OR_OTHER||||||<|0.25|TWO_SIDED|||||This p-value is based on a false discovery rate adjustment for multiple hypothesis testing.|Mixed Models Analysis|||This analysis is from baseline to 2-months post-treatment.||||<0.25
72546055|NCT01506323|144621965|SUPERIORITY_OR_OTHER||||||<|0.99|TWO_SIDED|||||This p-value is based on a false discovery rate adjustment for multiple hypothesis testing.|Mixed Models Analysis|||This analysis is from baseline to post-treatment. Cronbach's alpha for this study was .89 at baseline.||||<0.99
72546056|NCT01506323|144621965|SUPERIORITY_OR_OTHER||||||<|0.94|TWO_SIDED|||||This p-value is based on a false discovery rate adjustment for multiple hypothesis testing.|Mixed Models Analysis|||This analysis is from baseline to 2-months post-treatment.||||<0.94
72546057|NCT01506323|144621966|SUPERIORITY_OR_OTHER||||||<|0.12|TWO_SIDED|||||This p-value is based on a false discovery rate adjustment for multiple hypothesis testing.|Mixed Models Analysis|||This analysis is from baseline to post-treatment. Cronbach's alpha for this study was .88 at baseline.||||<0.12
72546058|NCT01506323|144621966|SUPERIORITY_OR_OTHER||||||<|0.49|TWO_SIDED|||||This p-value is based on a false discovery rate adjustment for multiple hypothesis testing.|Mixed Models Analysis|||This analysis is from baseline to 2-months post-treatment.||||<0.49
72546059|NCT01506323|144621967|SUPERIORITY_OR_OTHER||||||<|0.59|TWO_SIDED|||||This p-value is based on a false discovery rate adjustment for multiple hypothesis testing.|Mixed Models Analysis|||This analysis is from baseline to post-treatment. Cronbach's alpha for total score was .89 at baseline.||||<0.59
72546060|NCT01506323|144621967|SUPERIORITY_OR_OTHER||||||<|0.1|TWO_SIDED|||||This p-value is based on a false discovery rate adjustment for multiple hypothesis testing.|Mixed Models Analysis|Mixed-effects, repeated measures models adjusting for demographic factors were implemented.||This analysis is from baseline to 2-months post-treatment.||||<0.10
72580430|NCT03718832|144690411|SUPERIORITY||Mean Difference (Net)|0.0006229|STANDARD_ERROR_OF_MEAN|0.1095781||0.9954683|TWO_SIDED|95.0|-0.2150785|0.2163243||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|t-test, 2 sided|||Unadjusted mean difference, 12 months after trial enrollment||0.2163243|-0.2150785|0.9954683
72546061|NCT02891200|144621968|SUPERIORITY||Predicted Mean Difference|1.46||||0.467|TWO_SIDED|95.0|-2.47|5.38|||Mixed Models Analysis|Mixed effects linear model with study site and setting as fixed effects, and adjusted for baseline SGRQ domain scores.||||5.38|-2.47|0.467
72546062|NCT01633827|144621988|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.05||||0.05|TWO_SIDED||||||t-test, 2 sided|||||||0.05
72546063|NCT01633827|144621989|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.025||||0.025|TWO_SIDED||||||t-test, 2 sided|||||||0.025
72546064|NCT01633827|144621990|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.5||||0.5|TWO_SIDED||||||t-test, 2 sided|||||||0.5
72546065|NCT01633827|144621991|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.5||||0.5|TWO_SIDED||||||t-test, 2 sided|||||||0.5
72546066|NCT01633827|144621992|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.001||||0.001|TWO_SIDED||||||t-test, 2 sided|||||||0.001
72546067|NCT02637557|144622008|SUPERIORITY||LS Mean Difference|-2.952||||0.6065|TWO_SIDED|95.0|-14.222|8.318||P-value based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||||8.318|-14.222|0.6065
72546068|NCT02637557|144622008|SUPERIORITY||LS Mean Difference|-9.036||||0.116|TWO_SIDED|95.0|-20.318|2.245||P-value based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||||2.245|-20.318|0.1160
72546069|NCT02637557|144622008|SUPERIORITY||LS Mean Difference|-11.943||||0.04|TWO_SIDED|95.0|-23.334|-0.551||P-value based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||||-0.551|-23.334|0.0400
72546070|NCT02637557|144622008|SUPERIORITY|||||||0.0225||||||Dose trend test performed using linear contrast statement.|trend test|||||||0.0225
72546071|NCT02637557|144622009|SUPERIORITY||LS Mean Difference|-3.711||||0.4795|TWO_SIDED|95.0|-14.028|6.606||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||||6.606|-14.028|0.4795
72546072|NCT02637557|144622009|SUPERIORITY||LS Mean Difference|-2.739||||0.602|TWO_SIDED|95.0|-13.066|7.588||P-value based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||||7.588|-13.066|0.6020
72546073|NCT02637557|144622009|SUPERIORITY||LS Mean Difference|-8.602||||0.1055|TWO_SIDED|95.0|-19.03|1.826||P-value based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||||1.826|-19.030|0.1055
72546074|NCT02637557|144622009|SUPERIORITY|||||||0.1387||||||Dose trend test performed using linear contrast statement.|trend test|||||||0.1387
72546075|NCT02637557|144622010|SUPERIORITY||LS Mean Difference|-0.058||||0.7488|TWO_SIDED|95.0|-0.415|0.299||P-value based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||||0.299|-0.415|0.7488
72546076|NCT02637557|144622010|SUPERIORITY||LS Mean Difference|-0.254||||0.1627|TWO_SIDED|95.0|-0.611|0.103||P-value based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||||0.103|-0.611|0.1627
72580431|NCT03718832|144690411|SUPERIORITY||Mean Difference (Net)|-0.0161147|STANDARD_ERROR_OF_MEAN|0.1115322||0.8852268|TWO_SIDED|95.0|-0.2357129|0.2034834||Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|Regression, Linear|||Adjusted mean difference for full controls, 12 months after trial enrollment||0.2034834|-0.2357129|0.8852268
72546077|NCT02637557|144622010|SUPERIORITY||LS Mean Difference|-0.417||||0.0237|TWO_SIDED|95.0|-0.777|-0.056||P-value based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||||-0.056|-0.777|0.0237
72546078|NCT02637557|144622010|SUPERIORITY|||||||0.013||||||Dose trend test performed using linear contrast statement.|trend test|||||||0.0130
72546079|NCT02637557|144622011|SUPERIORITY||LS Mean Difference|-0.052||||0.747|TWO_SIDED|95.0|-0.369|0.265||P-value based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||||0.265|-0.369|0.7470
72546080|NCT02637557|144622011|SUPERIORITY||LS Mean Difference|-0.047||||0.7699|TWO_SIDED|95.0|-0.364|0.27||P-value based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||||0.270|-0.364|0.7699
72546081|NCT02637557|144622011|SUPERIORITY||LS Mean Difference|-0.257||||0.1157|TWO_SIDED|95.0|-0.577|0.064||P-value based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||||0.064|-0.577|0.1157
72546082|NCT02637557|144622011|SUPERIORITY|||||||0.1374||||||Dose trend test performed using linear contrast statement.|trend test|||||||0.1374
72546083|NCT02637557|144622012|SUPERIORITY||Odds Ratio (OR)|0.91||||0.7903|TWO_SIDED|95.0|0.47|1.77||Odds ratio, 95% confidence interval (CI) for the odds ratio and p-value vs. placebo are obtained from the Cochran-Mantel-Haenszel (CMH) tests controlling for esophagitis status.|Cochran-Mantel-Haenszel|||||1.77|0.47|0.7903
72580432|NCT03718832|144690412|SUPERIORITY||Mean Difference (Net)|0.9013876|STANDARD_ERROR_OF_MEAN|0.4414753||0.0417413|TWO_SIDED|95.0|0.0338441|1.768931||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|t-test, 2 sided|||Unadjusted mean difference, 6 months after trial enrollment||1.768931|0.0338441|0.0417413
72580433|NCT03718832|144690412|SUPERIORITY||Mean Difference (Net)|0.8939751|STANDARD_ERROR_OF_MEAN|0.3896126||0.0222222|TWO_SIDED|95.0|0.1282798|1.65967||Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|Regression, Linear|||Adjusted mean difference for full controls, 6 months after trial enrollment||1.65967|0.1282798|0.0222222
72546084|NCT02637557|144622012|SUPERIORITY||Odds Ratio (OR)|1.38||||0.3518|TWO_SIDED|95.0|0.7|2.71||Odds ratio, 95% CI for the odds ratio and p-value vs. placebo are obtained from the CMH tests controlling for esophagitis status.|Cochran-Mantel-Haenszel|||||2.71|0.70|0.3518
72546085|NCT02637557|144622012|SUPERIORITY||Odds Ratio (OR)|1.64||||0.1544|TWO_SIDED|95.0|0.83|3.26||Odds ratio, 95% CI for the odds ratio and p-value vs. placebo are obtained from the CMH tests controlling for esophagitis status.|Cochran-Mantel-Haenszel|||||3.26|0.83|0.1544
72546086|NCT02637557|144622013|SUPERIORITY||Odds Ratio (OR)|0.56||||0.1489|TWO_SIDED|95.0|0.25|1.23||Odds ratio, 95% CI for the odds ratio and p-value vs. placebo are obtained from the CMH tests controlling for esophagitis status.|Cochran-Mantel-Haenszel|||||1.23|0.25|0.1489
72546087|NCT02637557|144622013|SUPERIORITY||Odds Ratio (OR)|1.05||||0.8891|TWO_SIDED|95.0|0.51|2.19||Odds ratio, 95% CI for the odds ratio and p-value vs. placebo are obtained from the CMH tests controlling for esophagitis status.|Cochran-Mantel-Haenszel|||||2.19|0.51|0.8891
72546088|NCT02637557|144622013|SUPERIORITY||Odds Ratio (OR)|1.56||||0.2237|TWO_SIDED|95.0|0.76|3.2||Odds ratio, 95% CI for the odds ratio and p-value vs. placebo are obtained from the CMH tests controlling for esophagitis status.|Cochran-Mantel-Haenszel|||||3.20|0.76|0.2237
72546089|NCT02637557|144622014|SUPERIORITY||Odds Ratio (OR)|1.24||||0.6566|TWO_SIDED|95.0|0.48|3.18||Odds ratio, 95% CI (Confidence Interval) for the Odds Ratio and p-value vs. placebo are obtained from the CMH tests controlling for esophagitis status.|Cochran-Mantel-Haenszel|||||3.18|0.48|0.6566
72546090|NCT02637557|144622014|SUPERIORITY||Odds Ratio (OR)|2.01||||0.128|TWO_SIDED|95.0|0.81|4.98||Odds ratio, 95% CI (Confidence Interval) for the Odds Ratio and p-value vs. placebo are obtained from the CMH tests controlling for esophagitis status.|Cochran-Mantel-Haenszel|||||4.98|0.81|0.1280
72546091|NCT02637557|144622014|SUPERIORITY||Odds Ratio (OR)|1.97||||0.1463|TWO_SIDED|95.0|0.79|4.91||Odds ratio, 95% CI (Confidence Interval) for the Odds Ratio and p-value vs. placebo are obtained from the CMH tests controlling for esophagitis status.|Cochran-Mantel-Haenszel|||||4.91|0.79|0.1463
72546092|NCT02637557|144622015|SUPERIORITY||LS Mean Difference|-0.298||||0.5504|TWO_SIDED|95.0|-1.279|0.683||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||||0.683|-1.279|0.5504
72546093|NCT02637557|144622015|SUPERIORITY||LS Mean Difference|0.252||||0.6177|TWO_SIDED|95.0|-0.741|1.244||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||||1.244|-0.741|0.6177
72546094|NCT02637557|144622015|SUPERIORITY||LS Mean Difference|0.513||||0.3138|TWO_SIDED|95.0|-0.488|1.513||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||||1.513|-0.488|0.3138
72546095|NCT02637557|144622016|SUPERIORITY||LS Mean Difference|0.019||||0.9675|TWO_SIDED|95.0|-0.897|0.935||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||||0.935|-0.897|0.9675
72546096|NCT02637557|144622016|SUPERIORITY||LS Mean Difference|0.419||||0.3741|TWO_SIDED|95.0|-0.507|1.345||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||||1.345|-0.507|0.3741
72580434|NCT03718832|144690412|SUPERIORITY||Mean Difference (Net)|0.0276596|STANDARD_ERROR_OF_MEAN|0.7606961||0.9710103|TWO_SIDED|95.0|-1.467185|1.522504||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|t-test, 2 sided|||Unadjusted mean difference, 12 months after trial enrollment||1.522504|-1.467185|0.9710103
72411980|NCT01344460|144332044|SUPERIORITY_OR_OTHER||Percentage difference|17.4|||<|0|TWO_SIDED|95.0|14.3||Not Appropriate, upper intervals were not used in the statistical analysis and were not of interest for the study.||McNemar|||Blinded reader 3; Superiority analysis; The percentage difference was calculated as gadobutrol-enhanced minus unenhanced MRA.|||14.3|<0.000
72411981|NCT01344460|144332044|SUPERIORITY_OR_OTHER||Percentage difference|25.6|||<|0|TWO_SIDED|95.0|21.9||Not Appropriate, upper intervals were not used in the statistical analysis and were not of interest for the study.||McNemar|||Clinical investigator; Superiority analysis; The percentage difference was calculated as gadobutrol-enhanced minus unenhanced MRA.|||21.9|<0.000
72546097|NCT02637557|144622016|SUPERIORITY||LS Mean Difference|0.461||||0.3275|TWO_SIDED|95.0|-0.464|1.385||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||||1.385|-0.464|0.3275
72546098|NCT02637557|144622017|SUPERIORITY||LS Mean Difference|0.023||||0.856|TWO_SIDED|95.0|-0.226|0.272||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 1||0.272|-0.226|0.8560
72546099|NCT02637557|144622017|SUPERIORITY||LS Mean Difference|0.124||||0.3301|TWO_SIDED|95.0|-0.126|0.373||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 1||0.373|-0.126|0.3301
72546100|NCT02637557|144622017|SUPERIORITY||LS Mean Difference|-0.019||||0.8845|TWO_SIDED|95.0|-0.27|0.233||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 1||0.233|-0.270|0.8845
72546101|NCT02637557|144622017|SUPERIORITY||LS Mean Difference|0.02||||0.8879|TWO_SIDED|95.0|-0.262|0.303||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 2||0.303|-0.262|0.8879
72546102|NCT02637557|144622017|SUPERIORITY||LS Mean Difference|0.017||||0.9072|TWO_SIDED|95.0|-0.266|0.299||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 2||0.299|-0.266|0.9072
72546103|NCT02637557|144622017|SUPERIORITY||LS Mean Difference|-0.108||||0.4573|TWO_SIDED|95.0|-0.393|0.177||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 2||0.177|-0.393|0.4573
72546104|NCT02637557|144622017|SUPERIORITY||LS Mean Difference|-0.049||||0.7476|TWO_SIDED|95.0|-0.35|0.251||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 3||0.251|-0.350|0.7476
72546105|NCT02637557|144622017|SUPERIORITY||LS Mean Difference|-0.062||||0.6873|TWO_SIDED|95.0|-0.362|0.239||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 3||0.239|-0.362|0.6873
72546106|NCT02637557|144622017|SUPERIORITY||LS Mean Difference|-0.258||||0.0952|TWO_SIDED|95.0|-0.562|0.045||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 3||0.045|-0.562|0.0952
72546107|NCT02637557|144622017|SUPERIORITY||LS Mean Difference|-0.018||||0.9111|TWO_SIDED|95.0|-0.326|0.291||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 4||0.291|-0.326|0.9111
72546108|NCT02637557|144622017|SUPERIORITY||LS Mean Difference|0.004||||0.9772|TWO_SIDED|95.0|-0.304|0.313||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 4||0.313|-0.304|0.9772
72546109|NCT02637557|144622017|SUPERIORITY||LS Mean Difference|-0.235||||0.139|TWO_SIDED|95.0|-0.546|0.077||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 4||0.077|-0.546|0.1390
72546110|NCT02637557|144622017|SUPERIORITY||LS Mean Difference|-0.017||||0.9215|TWO_SIDED|95.0|-0.349|0.316||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 5||0.316|-0.349|0.9215
72546111|NCT02637557|144622017|SUPERIORITY||LS Mean Difference|-0.055||||0.7453|TWO_SIDED|95.0|-0.388|0.278||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 5||0.278|-0.388|0.7453
72552653|NCT02605395|144636102|EQUIVALENCE|The confidence intervals of logarithmically transformed ratio (Idiazole/Pariet) for Cmax to be within 80-125% to prove equivalency.|Ratio of means|95.71|||||TWO_SIDED|90.0|90.12|101.65||||||||101.65|90.12|
72552654|NCT02605395|144636103|EQUIVALENCE|The confidence intervals of logarithmically transformed ratio (Idiazole/Pariet) for AUC(0-t) to be within 80-125% to prove equivalency.|Ratio of means|96.5|||||TWO_SIDED|90.0|90.02|103.44||||||||103.44|90.02|
72552655|NCT02605395|144636104|EQUIVALENCE|The confidence intervals of logarithmically transformed ratio (Idiazole/Pariet) for AUC (0 to infinity) to be within 80-125% to prove equivalency.|Ratio of means|95.69|||||TWO_SIDED|90.0|87.06|105.17||||||||105.17|87.06|
72552656|NCT04459585|144636125|OTHER|Least squares (LS) means were calculated from an analysis of variance (ANOVA) model on log-transformed scale. The LS means for each treatment were back transformed from the log scale to provide estimates of the geometric means (GMS). The ratio (%) of GMS was calculated and 90% Confidence Intervals (CIs) for the ratio (%) of GMS were presented.|Ratio (%) of Geometric LS Mean|111.88|||||TWO_SIDED|90.0|77.57|161.35|||||For the comparison, the Dabigatran Etexilate + Quizartinib (Period 2) represents the numerator and Dabigatran Etexilate (Period 1) represents the denominator.|Statistical comparison was analyzed for Total Dabigatran.||161.35|77.57|
72552657|NCT04459585|144636125|OTHER|Least squares (LS) means were calculated from an analysis of variance (ANOVA) model on log-transformed scale. The LS means for each treatment were back transformed from the log scale to provide estimates of the geometric means (GMS). The ratio (%) of GMS was calculated and 90% CIs for the ratio (%) of GMS were presented.|Ratio (%) of Geometric LS Mean|112.98|||||TWO_SIDED|90.0|77.2|165.34|||||For the comparison, the Dabigatran Etexilate + Quizartinib (Period 2) represents the numerator and Dabigatran Etexilate (Period 1) represents the denominator.|Statistical comparison was analyzed for Free Dabigatran.||165.34|77.20|
72546112|NCT02637557|144622017|SUPERIORITY||LS Mean Difference|-0.393||||0.022|TWO_SIDED|95.0|-0.729|-0.057||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 5||-0.057|-0.729|0.0220
72546113|NCT02637557|144622017|SUPERIORITY||LS Mean Difference|0.053||||0.7561|TWO_SIDED|95.0|-0.282|0.387||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 6||0.387|-0.282|0.7561
72546114|NCT02637557|144622017|SUPERIORITY||LS Mean Difference|-0.071||||0.6758|TWO_SIDED|95.0|-0.406|0.263||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 6||0.263|-0.406|0.6758
72546115|NCT02637557|144622017|SUPERIORITY||LS Mean Difference|-0.348||||0.0434|TWO_SIDED|95.0|-0.686|-0.01||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 6||-0.010|-0.686|0.0434
72546116|NCT02637557|144622017|SUPERIORITY||LS Mean Difference|0.042||||0.8123|TWO_SIDED|95.0|-0.308|0.392||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 7||0.392|-0.308|0.8123
72546117|NCT02637557|144622017|SUPERIORITY||LS Mean Difference|-0.044||||0.8038|TWO_SIDED|95.0|-0.394|0.306||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 7||0.306|-0.394|0.8038
72580435|NCT03718832|144690412|SUPERIORITY||Mean Difference (Net)|0.0377244|STANDARD_ERROR_OF_MEAN|0.6523585||0.9539117|TWO_SIDED|95.0|-1.244338|1.319787||Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|Regression, Linear|||Adjusted mean difference for full controls, 12 months after trial enrollment||1.319787|-1.244338|0.9539117
72546118|NCT02637557|144622017|SUPERIORITY||LS Mean Difference|-0.3||||0.0954|TWO_SIDED|95.0|-0.654|0.053||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 7||0.053|-0.654|0.0954
72546119|NCT02637557|144622017|SUPERIORITY||LS Mean Difference|-0.078||||0.6649|TWO_SIDED|95.0|-0.43|0.275||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 8||0.275|-0.430|0.6649
72546120|NCT02637557|144622017|SUPERIORITY||LS Mean Difference|-0.262||||0.1448|TWO_SIDED|95.0|-0.614|0.091||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 8||0.091|-0.614|0.1448
72546121|NCT02637557|144622017|SUPERIORITY||LS Mean Difference|-0.403||||0.0264|TWO_SIDED|95.0|-0.759|-0.048||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 8||-0.048|-0.759|0.0264
72546122|NCT02637557|144622018|SUPERIORITY||LS Mean Difference|0.102||||0.4137|TWO_SIDED|95.0|-0.143|0.347||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 1||0.347|-0.143|0.4137
72546123|NCT02637557|144622018|SUPERIORITY||LS Mean Difference|0.147||||0.2395|TWO_SIDED|95.0|-0.098|0.392||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 1||0.392|-0.098|0.2395
72546124|NCT02637557|144622018|SUPERIORITY||LS Mean Difference|-0.036||||0.7729|TWO_SIDED|95.0|-0.284|0.212||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 1||0.212|-0.284|0.7729
72546125|NCT02637557|144622018|SUPERIORITY||LS Mean Difference|0.079||||0.5824|TWO_SIDED|95.0|-0.205|0.363||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 2||0.363|-0.205|0.5824
72546126|NCT02637557|144622018|SUPERIORITY||LS Mean Difference|0.028||||0.8466|TWO_SIDED|95.0|-0.256|0.312||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 2||0.312|-0.256|0.8466
72546127|NCT02637557|144622018|SUPERIORITY||LS Mean Difference|-0.118||||0.4192|TWO_SIDED|95.0|-0.405|0.169||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 2||0.169|-0.405|0.4192
72546128|NCT02637557|144622018|SUPERIORITY||LS Mean Difference|-0.035||||0.8192|TWO_SIDED|95.0|-0.333|0.264||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 3||0.264|-0.333|0.8192
72546129|NCT02637557|144622018|SUPERIORITY||LS Mean Difference|-0.073||||0.632|TWO_SIDED|95.0|-0.372|0.226||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 3||0.226|-0.372|0.6320
72546130|NCT02637557|144622018|SUPERIORITY||LS Mean Difference|-0.345||||0.0254|TWO_SIDED|95.0|-0.647|-0.043||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 3||-0.043|-0.647|0.0254
72546131|NCT02637557|144622018|SUPERIORITY||LS Mean Difference|-0.047||||0.7689|TWO_SIDED|95.0|-0.36|0.266||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 4||0.266|-0.360|0.7689
72546132|NCT02637557|144622018|SUPERIORITY||LS Mean Difference|-0.117||||0.4631|TWO_SIDED|95.0|-0.43|0.196||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 4||0.196|-0.430|0.4631
72411982|NCT01344460|144332045|NON_INFERIORITY_OR_EQUIVALENCE|using a -7.5% non-inferiority margin|Percentage difference|6.8|||||TWO_SIDED|95.0|-2.2||Not Appropriate, upper intervals were not used in the statistical analysis and were not of interest for the study.||The cluster-adjusted two-sided 95% CI|||Majority reader; The percentage difference was calculated as gadobutrol-enhanced minus unenhanced MRA.|||-2.2|
72546133|NCT02637557|144622018|SUPERIORITY||LS Mean Difference|-0.298||||0.0651|TWO_SIDED|95.0|-0.615|0.019||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 4||0.019|-0.615|0.0651
72546134|NCT02637557|144622018|SUPERIORITY||LS Mean Difference|-0.06||||0.7197|TWO_SIDED|95.0|-0.392|0.271||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 5||0.271|-0.392|0.7197
72546135|NCT02637557|144622018|SUPERIORITY||LS Mean Difference|-0.097||||0.5649|TWO_SIDED|95.0|-0.428|0.234||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 5||0.234|-0.428|0.5649
72546136|NCT02637557|144622018|SUPERIORITY||LS Mean Difference|-0.422||||0.0138|TWO_SIDED|95.0|-0.757|-0.087||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 5||-0.087|-0.757|0.0138
72546137|NCT02637557|144622018|SUPERIORITY||LS Mean Difference|0.06||||0.7202|TWO_SIDED|95.0|-0.269|0.388||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 6||0.388|-0.269|0.7202
72546138|NCT02637557|144622018|SUPERIORITY||LS Mean Difference|-0.093||||0.5784|TWO_SIDED|95.0|-0.421|0.236||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 6||0.236|-0.421|0.5784
72546139|NCT02637557|144622018|SUPERIORITY||LS Mean Difference|-0.376||||0.0266|TWO_SIDED|95.0|-0.708|-0.044||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 6||-0.044|-0.708|0.0266
72546140|NCT02637557|144622018|SUPERIORITY||LS Mean Difference|-0.049||||0.777|TWO_SIDED|95.0|-0.391|0.293||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 7||0.293|-0.391|0.7770
72546141|NCT02637557|144622018|SUPERIORITY||LS Mean Difference|-0.114||||0.5121|TWO_SIDED|95.0|-0.456|0.228||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 7||0.228|-0.456|0.5121
72546142|NCT02637557|144622018|SUPERIORITY||LS Mean Difference|-0.366||||0.0384|TWO_SIDED|95.0|-0.711|-0.02||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 7||-0.020|-0.711|0.0384
72546143|NCT02637557|144622018|SUPERIORITY||LS Mean Difference|-0.093||||0.5876|TWO_SIDED|95.0|-0.431|0.245||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 8||0.245|-0.431|0.5876
72546144|NCT02637557|144622018|SUPERIORITY||LS Mean Difference|-0.298||||0.0842|TWO_SIDED|95.0|-0.636|0.04||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 8||0.040|-0.636|0.0842
72546145|NCT02637557|144622018|SUPERIORITY||LS Mean Difference|-0.452||||0.0098|TWO_SIDED|95.0|-0.793|-0.11||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 8||-0.110|-0.793|0.0098
72546146|NCT02637557|144622019|SUPERIORITY||LS Mean Difference|0.054||||0.6663|TWO_SIDED|95.0|-0.193|0.301||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 1||0.301|-0.193|0.6663
72546147|NCT02637557|144622019|SUPERIORITY||LS Mean Difference|0.148||||0.24|TWO_SIDED|95.0|-0.1|0.396||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 1||0.396|-0.100|0.2400
72546148|NCT02637557|144622019|SUPERIORITY||LS Mean Difference|-0.023||||0.856|TWO_SIDED|95.0|-0.273|0.227||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 1||0.227|-0.273|0.8560
72546149|NCT02637557|144622019|SUPERIORITY||LS Mean Difference|0.051||||0.7209|TWO_SIDED|95.0|-0.232|0.335||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 2||0.335|-0.232|0.7209
72546150|NCT02637557|144622019|SUPERIORITY||LS Mean Difference|-0.013||||0.9283|TWO_SIDED|95.0|-0.297|0.271||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 2||0.271|-0.297|0.9283
72580436|NCT03718832|144690413|SUPERIORITY||Mean Difference (Net)|-0.1045328|STANDARD_ERROR_OF_MEAN|0.1417549||0.4612408|TWO_SIDED|95.0|-0.3830955|0.1740299||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|t-test, 2 sided|||Unadjusted mean difference, 6 months after trial enrollment||0.1740299|-0.3830955|0.4612408
72580437|NCT03718832|144690413|SUPERIORITY||Mean Difference (Net)|-0.0552724|STANDARD_ERROR_OF_MEAN|0.1181649||0.6401864|TWO_SIDED|95.0|-0.2874987|0.176954||Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|Regression, Linear|||Adjusted mean difference for full controls, 6 months after trial enrollment||0.176954|-0.2874987|0.6401864
72411983|NCT01344460|144332045|NON_INFERIORITY_OR_EQUIVALENCE|using a -7.5% non-inferiority margin|Percentage difference|0.0|||||TWO_SIDED|95.0|-9.7||Not Appropriate, upper intervals were not used in the statistical analysis and were not of interest for the study.||The cluster-adjusted two-sided 95% CI|||Blinded reader 1; the percentage difference was calculated as gadobutrol-enhanced minus unenhanced MRA.|||-9.7|
72411984|NCT01344460|144332045|NON_INFERIORITY_OR_EQUIVALENCE|using a -7.5% non-inferiority margin|Percentage difference|14.3|||||TWO_SIDED|95.0|5.1||Not Appropriate, upper intervals were not used in the statistical analysis and were not of interest for the study.||The cluster-adjusted two-sided 95% CI|||Blinded reader 2; the percentage difference was calculated as gadobutrol-enhanced minus unenhanced MRA.|||5.1|
72411985|NCT01344460|144332045|NON_INFERIORITY_OR_EQUIVALENCE|using a -7.5% non-inferiority margin|Percentage difference|3.0|||||TWO_SIDED|95.0|-5.8||Not Appropriate, upper intervals were not used in the statistical analysis and were not of interest for the study.||The cluster-adjusted two-sided 95% CI|||Blinded reader 3; the percentage difference was calculated as gadobutrol-enhanced minus unenhanced MRA.|||-5.8|
72411986|NCT01344460|144332045|NON_INFERIORITY_OR_EQUIVALENCE|using a -7.5% non-inferiority margin|Percentage difference|20.0|||||TWO_SIDED|95.0|11.7||Not Appropriate, upper intervals were not used in the statistical analysis and were not of interest for the study.||The cluster-adjusted two-sided 95% CI|||Clinical investigator; the percentage difference was calculated as gadobutrol-enhanced minus unenhanced MRA.|||11.7|
72546151|NCT02637557|144622019|SUPERIORITY||LS Mean Difference|-0.162||||0.2659|TWO_SIDED|95.0|-0.449|0.124||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 2||0.124|-0.449|0.2659
72546152|NCT02637557|144622019|SUPERIORITY||LS Mean Difference|-0.006||||0.968|TWO_SIDED|95.0|-0.31|0.298||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 3||0.298|-0.310|0.9680
72546153|NCT02637557|144622019|SUPERIORITY||LS Mean Difference|-0.125||||0.4213|TWO_SIDED|95.0|-0.429|0.18||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 3||0.180|-0.429|0.4213
72546154|NCT02637557|144622019|SUPERIORITY||LS Mean Difference|-0.311||||0.0471|TWO_SIDED|95.0|-0.618|-0.004||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 3||-0.004|-0.618|0.0471
72546155|NCT02637557|144622019|SUPERIORITY||LS Mean Difference|-0.025||||0.8769|TWO_SIDED|95.0|-0.337|0.288||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 4||0.288|-0.337|0.8769
72546156|NCT02637557|144622019|SUPERIORITY||LS Mean Difference|-0.059||||0.7109|TWO_SIDED|95.0|-0.372|0.254||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 4||0.254|-0.372|0.7109
72546157|NCT02637557|144622019|SUPERIORITY||LS Mean Difference|-0.254||||0.1146|TWO_SIDED|95.0|-0.57|0.062||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 4||0.062|-0.570|0.1146
72546158|NCT02637557|144622019|SUPERIORITY||LS Mean Difference|0.048||||0.7736|TWO_SIDED|95.0|-0.281|0.378||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 5||0.378|-0.281|0.7736
72546159|NCT02637557|144622019|SUPERIORITY||LS Mean Difference|-0.02||||0.9059|TWO_SIDED|95.0|-0.35|0.31||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 5||0.310|-0.350|0.9059
72546160|NCT02637557|144622019|SUPERIORITY||LS Mean Difference|-0.299||||0.0779|TWO_SIDED|95.0|-0.633|0.034||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 5||0.034|-0.633|0.0779
72546161|NCT02637557|144622019|SUPERIORITY||LS Mean Difference|0.086||||0.6068|TWO_SIDED|95.0|-0.241|0.412||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 6||0.412|-0.241|0.6068
72546162|NCT02637557|144622019|SUPERIORITY||LS Mean Difference|-0.024||||0.8838|TWO_SIDED|95.0|-0.352|0.303||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 5||0.303|-0.352|0.8838
72546163|NCT02637557|144622019|SUPERIORITY||LS Mean Difference|-0.323||||0.0556|TWO_SIDED|95.0|-0.653|0.008||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 6||0.008|-0.653|0.0556
72580438|NCT03718832|144690413|SUPERIORITY||Mean Difference (Net)|-0.2761332|STANDARD_ERROR_OF_MEAN|0.2593125||0.2874913|TWO_SIDED|95.0|-0.7857084|0.2334419||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|t-test, 2 sided|||Unadjusted mean difference, 12 months after trial enrollment||0.2334419|-0.7857084|0.2874913
72580439|NCT03718832|144690413|SUPERIORITY||Mean Difference (Net)|-0.155843|STANDARD_ERROR_OF_MEAN|0.2092772||0.4568601|TWO_SIDED|95.0|-0.56713|0.2554439||Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|Regression, Linear|||Adjusted mean difference for full controls, 12 months after trial enrollment||0.2554439|-0.56713|0.4568601
72411987|NCT01344460|144332046|NON_INFERIORITY_OR_EQUIVALENCE|using a -7.5% non-inferiority margin|Percentage difference|9.0|||||TWO_SIDED|95.0|7.0||Not Appropriate, upper intervals were not used in the statistical analysis and were not of interest for the study.||The cluster-adjusted two-sided 95% CI|||Majority reader; The percentage difference was calculated as gadobutrol-enhanced minus unenhanced MRA.|||7.0|
72411988|NCT01344460|144332046|NON_INFERIORITY_OR_EQUIVALENCE|using a -7.5% non-inferiority margin|Percentage difference|11.3|||||TWO_SIDED|95.0|9.1||Not Appropriate, upper intervals were not used in the statistical analysis and were not of interest for the study.||The cluster-adjusted two-sided 95% CI|||Blinded reader 1; the percentage difference was calculated as gadobutrol-enhanced minus unenhanced MRA.|||9.1|
72411989|NCT01344460|144332046|NON_INFERIORITY_OR_EQUIVALENCE|using a -7.5% non-inferiority margin|Percentage difference|9.7|||||TWO_SIDED|95.0|7.6||Not Appropriate, upper intervals were not used in the statistical analysis and were not of interest for the study.||The cluster-adjusted two-sided 95% CI|||Blinded reader 2; the percentage difference was calculated as gadobutrol-enhanced minus unenhanced MRA.|||7.6|
72411990|NCT01344460|144332046|NON_INFERIORITY_OR_EQUIVALENCE|using a -7.5% non-inferiority margin|Percentage difference|13.4|||||TWO_SIDED|95.0|11.2||Not Appropriate, upper intervals were not used in the statistical analysis and were not of interest for the study.||The cluster-adjusted two-sided 95% CI|||Blinded reader 3; the percentage difference was calculated as gadobutrol-enhanced minus unenhanced MRA.|||11.2|
72411991|NCT01344460|144332046|NON_INFERIORITY_OR_EQUIVALENCE|using a -7.5% non-inferiority margin|Percentage difference|13.1|||||TWO_SIDED|95.0|11.0||Not Appropriate, upper intervals were not used in the statistical analysis and were not of interest for the study.||The cluster-adjusted two-sided 95% CI|||Clinical investigator; the percentage difference was calculated as gadobutrol-enhanced minus unenhanced MRA.|||11.0|
72411992|NCT01344460|144332047|SUPERIORITY_OR_OTHER||percentage|54.6|||||ONE_SIDED|95.0|46.2||||One sided 95% confidence interval|||Majority reader|||46.2|
72411993|NCT01344460|144332047|SUPERIORITY_OR_OTHER||percentage|51.6|||||ONE_SIDED|95.0|43.6||||One sided 95% confidence interval|||Blinded Reader 1|||43.6|
72411994|NCT01344460|144332047|SUPERIORITY_OR_OTHER||percentage|54.4|||||ONE_SIDED|95.0|45.5||||One sided 95% confidence interval|||Blinded Reader 2|||45.5|
72411995|NCT01344460|144332047|SUPERIORITY_OR_OTHER||percentage|53.4|||||ONE_SIDED|95.0|44.8||||One sided 95% confidence interval|||Blinded Reader 3|||44.8|
72411996|NCT01344460|144332047|SUPERIORITY_OR_OTHER||percentage|71.3|||||ONE_SIDED|95.0|64.7||||One sided 95% confidence interval|||Clinical investigator|||64.7|
72546164|NCT02637557|144622019|SUPERIORITY||LS Mean Difference|-0.051||||0.7673|TWO_SIDED|95.0|-0.389|0.287||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 7||0.287|-0.389|0.7673
72546165|NCT02637557|144622019|SUPERIORITY||LS Mean Difference|-0.05||||0.7709|TWO_SIDED|95.0|-0.389|0.289||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 7||0.289|-0.389|0.7709
72580440|NCT03718832|144690414|SUPERIORITY||Mean Difference (Net)|0.0539315|STANDARD_ERROR_OF_MEAN|0.0267347||0.0442418|TWO_SIDED|95.0|0.0013953|0.1064678||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|t-test, 2 sided|||Unadjusted mean difference, 6 months after trial enrollment||0.1064678|0.0013953|0.0442418
72411997|NCT01344460|144332048|SUPERIORITY_OR_OTHER||percentage|95.9|||||ONE_SIDED|95.0|94.9||||One sided 95% confidence interval|||Majority reader|||94.9|
72411998|NCT01344460|144332048|SUPERIORITY_OR_OTHER||percentage|95.0|||||ONE_SIDED|95.0|93.8||||One sided 95% confidence interval|||Blinded Reader 1|||93.8|
72580441|NCT03718832|144690414|SUPERIORITY||Mean Difference (Net)|0.0546574|STANDARD_ERROR_OF_MEAN|0.0272506||0.0454857|TWO_SIDED|95.0|0.0011025|0.1082124||Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|Regression, Linear|||Adjusted mean difference for full controls, 6 months after trial enrollment||0.1082124|0.0011025|0.0454857
72411999|NCT01344460|144332048|SUPERIORITY_OR_OTHER||percentage|96.2|||||ONE_SIDED|95.0|95.2||||One sided 95% confidence interval|||Blinded Reader 2|||95.2|
72412000|NCT01344460|144332048|SUPERIORITY_OR_OTHER||percentage|95.8|||||ONE_SIDED|95.0|94.8||||One sided 95% confidence interval|||Blinded Reader 3|||94.8|
72412001|NCT01344460|144332048|SUPERIORITY_OR_OTHER||percentage|98.4|||||ONE_SIDED|95.0|97.8||||One sided 95% confidence interval|||Clinical investigator|||97.8|
72412002|NCT01344460|144332051|SUPERIORITY_OR_OTHER||Diameter difference|0.17|STANDARD_DEVIATION|1.28|||||||||Mean Difference|||CTA Minus Unenhanced MRA for blinded Reader on vessel DIA at normal point||||
72412003|NCT01344460|144332051|SUPERIORITY_OR_OTHER||Diameter difference|-0.09|STANDARD_DEVIATION|1.14|||||||||Mean Difference|||CTA minus Gadobutrol-Enhanced MRA for blinded reader on vessel DIA at normal point||||
72412004|NCT01344460|144332051|SUPERIORITY_OR_OTHER||Mean Difference|0.41|STANDARD_DEVIATION|1.15|||||||||Mean Difference|||CTA minus Unenhanced MRA for blinded reader on vessel DIA at narrowest point||||
72412005|NCT01344460|144332051|SUPERIORITY_OR_OTHER||Diameter difference|-0.15|STANDARD_DEVIATION|1.01|||||||||Mean Difference|||CTA minus Gadobutrol-Enhanced MRA for blinded reader on vessel DIA at narrowest point||||
72412006|NCT03283670|144332066|SUPERIORITY||Mean Difference (Net)|-0.75||||0.55|TWO_SIDED||||||t-test, 2 sided|||HAMD-21 at 2 Hours, placebo vs 25% nitrous oxide||||0.55
72412007|NCT03283670|144332066|SUPERIORITY||Mean Difference (Net)|-1.4||||0.47|TWO_SIDED||||||t-test, 2 sided|||Change in HAMD-21, 25% nitrous oxide vs placebo at 24 hours||||0.47
72412008|NCT03283670|144332066|SUPERIORITY||Median Difference (Net)|-0.87||||0.49|TWO_SIDED||||||t-test, 2 sided|||HAMD-21 at 2 Hours, placebo vs 50% nitrous oxide||||0.49
72412009|NCT03283670|144332066|SUPERIORITY||Mean Difference (Net)|-1.9||||0.34|TWO_SIDED||||||t-test, 2 sided|||Change in HAMD-21 at 24 hours, placebo vs 50% nitrous oxide||||0.34
72412010|NCT03283670|144332066|SUPERIORITY||Mean Difference (Final Values)|-0.11||||0.94|TWO_SIDED||||||t-test, 2 sided|||Change in HAMD-21 at 2 hours, 25% nitrous oxide vs 50% nitrous oxide||||0.94
72412011|NCT03283670|144332066|SUPERIORITY||Mean Difference (Net)|-0.5||||0.8|TWO_SIDED||||||t-test, 2 sided|||Change in HAMD-21 at 24 hours, 25% nitrous oxide vs 50% nitrous oxide||||0.80
72412012|NCT05932290|144332086|SUPERIORITY||Hazard Ratio (HR)|0.51|||<|0.0001|TWO_SIDED|95.0|0.37|0.71|||Regression, Cox||Hazard ratios (HRs) were estimated using unadjusted Cox proportional hazard models.|||0.71|0.37|<.0001
72412013|NCT05932290|144332087|SUPERIORITY||Hazard Ratio (HR)|0.37||||0.0003|TWO_SIDED|95.0|0.22|0.64|||Regression, Cox||IPTW HRs were estimated using weighted Cox proportional hazard models and confidence intervals were estimated using robust error variances.|||0.64|0.22|.0003
72546166|NCT02637557|144622019|SUPERIORITY||LS Mean Difference|-0.386||||0.0273|TWO_SIDED|95.0|-0.728|-0.043||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 7||-0.043|-0.728|0.0273
72546167|NCT02637557|144622019|SUPERIORITY||LS Mean Difference|-0.044||||0.795|TWO_SIDED|95.0|-0.378|0.289||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 8||0.289|-0.378|0.7950
72546168|NCT02637557|144622019|SUPERIORITY||LS Mean Difference|-0.236||||0.1656|TWO_SIDED|95.0|-0.57|0.098||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 8||0.098|-0.570|0.1656
72546169|NCT02637557|144622019|SUPERIORITY||LS Mean Difference|-0.385||||0.0254|TWO_SIDED|95.0|-0.722|-0.048||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 8||-0.048|-0.722|0.0254
72546170|NCT02637557|144622020|SUPERIORITY||LS Mean Difference|0.093||||0.3788|TWO_SIDED|95.0|-0.114|0.3||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 1||0.300|-0.114|0.3788
72546171|NCT02637557|144622020|SUPERIORITY||LS Mean Difference|0.189||||0.0761|TWO_SIDED|95.0|-0.02|0.397||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 1||0.397|-0.020|0.0761
72546172|NCT02637557|144622020|SUPERIORITY||LS Mean Difference|-0.021||||0.8415|TWO_SIDED|95.0|-0.232|0.189||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 1||0.189|-0.232|0.8415
72546173|NCT02637557|144622020|SUPERIORITY||LS Mean Difference|0.052||||0.6719|TWO_SIDED|95.0|-0.19|0.294||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 2||0.294|-0.190|0.6719
72546174|NCT02637557|144622020|SUPERIORITY||LS Mean Difference|0.007||||0.9549|TWO_SIDED|95.0|-0.237|0.251||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 2||0.251|-0.237|0.9549
72546175|NCT02637557|144622020|SUPERIORITY||LS Mean Difference|-0.096||||0.4408|TWO_SIDED|95.0|-0.342|0.149||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 2||0.149|-0.342|0.4408
72546176|NCT02637557|144622020|SUPERIORITY||LS Mean Difference|-0.004||||0.9736|TWO_SIDED|95.0|-0.262|0.253||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 3||0.253|-0.262|0.9736
72546177|NCT02637557|144622020|SUPERIORITY||LS Mean Difference|-0.146||||0.2703|TWO_SIDED|95.0|-0.405|0.114||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 3||0.114|-0.405|0.2703
72546178|NCT02637557|144622020|SUPERIORITY||LS Mean Difference|-0.351||||0.0087|TWO_SIDED|95.0|-0.612|-0.089||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 3||-0.089|-0.612|0.0087
72546179|NCT02637557|144622020|SUPERIORITY||LS Mean Difference|-0.026||||0.848|TWO_SIDED|95.0|-0.295|0.243||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 4||0.243|-0.295|0.8480
72546180|NCT02637557|144622020|SUPERIORITY||LS Mean Difference|-0.073||||0.5966|TWO_SIDED|95.0|-0.344|0.198||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 4||0.198|-0.344|0.5966
72546181|NCT02637557|144622020|SUPERIORITY||LS Mean Difference|-0.324||||0.0203|TWO_SIDED|95.0|-0.596|-0.051||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 4||-0.051|-0.596|0.0203
72546182|NCT02637557|144622020|SUPERIORITY||LS Mean Difference|-0.025||||0.854|TWO_SIDED|95.0|-0.294|0.244||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 5||0.244|-0.294|0.8540
72546183|NCT02637557|144622020|SUPERIORITY||LS Mean Difference|-0.022||||0.8757|TWO_SIDED|95.0|-0.293|0.25||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 5||0.250|-0.293|0.8757
72546184|NCT02637557|144622020|SUPERIORITY||LS Mean Difference|-0.332||||0.0174|TWO_SIDED|95.0|-0.605|-0.059||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 5||-0.059|-0.605|0.0174
72546185|NCT02637557|144622020|SUPERIORITY||LS Mean Difference|0.078||||0.5831|TWO_SIDED|95.0|-0.202|0.358||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 6||0.358|-0.202|0.5831
72546186|NCT02637557|144622020|SUPERIORITY||LS Mean Difference|-0.078||||0.5859|TWO_SIDED|95.0|-0.36|0.204||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 6||0.204|-0.360|0.5859
72546187|NCT02637557|144622020|SUPERIORITY||LS Mean Difference|-0.291||||0.0447|TWO_SIDED|95.0|-0.575|-0.007||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 6||-0.007|-0.575|0.0447
72546188|NCT02637557|144622020|SUPERIORITY||LS Mean Difference|0.093||||0.5365|TWO_SIDED|95.0|-0.203|0.388||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 7||0.388|-0.203|0.5365
72546189|NCT02637557|144622020|SUPERIORITY||LS Mean Difference|-0.057||||0.7067|TWO_SIDED|95.0|-0.355|0.241||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 7||0.241|-0.355|0.7067
72546190|NCT02637557|144622020|SUPERIORITY||LS Mean Difference|-0.317||||0.0386|TWO_SIDED|95.0|-0.616|-0.017||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 7||-0.017|-0.616|0.0386
72546191|NCT02637557|144622020|SUPERIORITY||LS Mean Difference|0.042||||0.7804|TWO_SIDED|95.0|-0.253|0.336||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 8||0.336|-0.253|0.7804
72546192|NCT02637557|144622020|SUPERIORITY||LS Mean Difference|-0.125||||0.4064|TWO_SIDED|95.0|-0.422|0.171||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 8||0.171|-0.422|0.4064
72546193|NCT02637557|144622020|SUPERIORITY||LS Mean Difference|-0.333||||0.0289|TWO_SIDED|95.0|-0.632|-0.035||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 8||-0.035|-0.632|0.0289
72546194|NCT02637557|144622021|SUPERIORITY||LS Mean Difference|0.037||||0.7207|TWO_SIDED|95.0|-0.167|0.241||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 1||0.241|-0.167|0.7207
72546195|NCT02637557|144622021|SUPERIORITY||LS Mean Difference|-0.071||||0.4946|TWO_SIDED|95.0|-0.275|0.133||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 1||0.133|-0.275|0.4946
72546196|NCT02637557|144622021|SUPERIORITY||LS Mean Difference|-0.077||||0.4596|TWO_SIDED|95.0|-0.283|0.129||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 1||0.129|-0.283|0.4596
72546197|NCT02637557|144622021|SUPERIORITY||LS Mean Difference|0.067||||0.5987|TWO_SIDED|95.0|-0.182|0.315||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 2||0.315|-0.182|0.5987
72580442|NCT03718832|144690414|SUPERIORITY||Mean Difference (Net)|0.0076781|STANDARD_ERROR_OF_MEAN|0.0188378||0.683764|TWO_SIDED|95.0|-0.0293401|0.0446963||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|t-test, 2 sided|||Unadjusted mean difference, 6 months after trial enrollment||0.0446963|-0.0293401|0.683764
72580443|NCT03718832|144690414|SUPERIORITY||Mean Difference (Net)|0.0053342|STANDARD_ERROR_OF_MEAN|0.0183059||0.7708852|TWO_SIDED|95.0|-0.0306419|0.0413103||Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|Regression, Linear|||Adjusted mean difference for full controls, 12 months after trial enrollment||0.0413103|-0.0306419|0.7708852
72580444|NCT03718832|144690415|SUPERIORITY||Mean Difference (Net)|-0.053099|STANDARD_ERROR_OF_MEAN|0.0436586||0.2245167|TWO_SIDED|95.0|-0.1388926|0.0326946||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|t-test, 2 sided|||Unadjusted mean difference, 6 months after trial enrollment||0.0326946|-0.1388926|0.2245167
72412014|NCT05932290|144332090|SUPERIORITY||Hazard Ratio (HR)|0.65||||0.0062|TWO_SIDED|95.0|0.47|0.88|||Regression, Cox||HRs were estimated using unadjusted Cox proportional hazard models.|||0.88|0.47|.0062
72412015|NCT05932290|144332091|SUPERIORITY||Hazard Ratio (HR)|0.46||||0.0032|TWO_SIDED|95.0|0.27|0.77|||Regression, Cox|IPTW HRs were estimated using weighted Cox proportional hazard models and confidence intervals were estimated using robust error variances.||||0.77|0.27|.0032
72546198|NCT02637557|144622021|SUPERIORITY||LS Mean Difference|-0.122||||0.3348|TWO_SIDED|95.0|-0.372|0.127||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 2||0.127|-0.372|0.3348
72546199|NCT02637557|144622021|SUPERIORITY||LS Mean Difference|-0.062||||0.6288|TWO_SIDED|95.0|-0.313|0.19||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 2||0.190|-0.313|0.6288
72546200|NCT02637557|144622021|SUPERIORITY||LS Mean Difference|-0.048||||0.7193|TWO_SIDED|95.0|-0.312|0.216||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 3||0.216|-0.312|0.7193
72546201|NCT02637557|144622021|SUPERIORITY||LS Mean Difference|-0.27||||0.0452|TWO_SIDED|95.0|-0.534|-0.006||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 3||-0.006|-0.534|0.0452
72580445|NCT03718832|144690415|SUPERIORITY||Mean Difference (Net)|-0.0815933|STANDARD_ERROR_OF_MEAN|0.0424438||0.0551913|TWO_SIDED|95.0|-0.1650069|0.0018204||Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|Regression, Linear|||Adjusted mean difference for full controls, 6 months after trial enrollment||0.0018204|-0.1650069|0.0551913
72580446|NCT03718832|144690415|SUPERIORITY||Mean Difference (Net)|-0.0506938|STANDARD_ERROR_OF_MEAN|0.0461078||0.2721373|TWO_SIDED|95.0|-0.1413002|0.0399126||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|t-test, 2 sided|||Unadjusted mean difference, 12 months after trial enrollment||0.0399126|-0.1413002|0.2721373
72546202|NCT02637557|144622021|SUPERIORITY||LS Mean Difference|-0.252||||0.0635|TWO_SIDED|95.0|-0.519|0.014||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 3||0.014|-0.519|0.0635
72546203|NCT02637557|144622021|SUPERIORITY||LS Mean Difference|-0.126||||0.38|TWO_SIDED|95.0|-0.409|0.156||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 4||0.156|-0.409|0.3800
72546204|NCT02637557|144622021|SUPERIORITY||LS Mean Difference|-0.336||||0.02|TWO_SIDED|95.0|-0.62|-0.053||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 4||-0.053|-0.620|0.0200
72546205|NCT02637557|144622021|SUPERIORITY||LS Mean Difference|-0.328||||0.0244|TWO_SIDED|95.0|-0.614|-0.043||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 4||-0.043|-0.614|0.0244
72546206|NCT02637557|144622021|SUPERIORITY||LS Mean Difference|-0.096||||0.5232|TWO_SIDED|95.0|-0.392|0.2||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 5||0.200|-0.392|0.5232
72546207|NCT02637557|144622021|SUPERIORITY||LS Mean Difference|-0.282||||0.0623|TWO_SIDED|95.0|-0.579|0.015||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 5||0.015|-0.579|0.0623
72546208|NCT02637557|144622021|SUPERIORITY||LS Mean Difference|-0.255||||0.0951|TWO_SIDED|95.0|-0.554|0.045||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 5||0.045|-0.554|0.0951
72580447|NCT03718832|144690415|SUPERIORITY||Mean Difference (Net)|-0.079563|STANDARD_ERROR_OF_MEAN|0.0428514||0.0640071|TWO_SIDED|95.0|-0.1637776|0.0046516||Adjusted mean difference for full controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|Regression, Linear|||Adjusted mean difference for full controls, 12 months after trial enrollment||0.0046516|-0.1637776|0.0640071
72580448|NCT03718832|144690416|SUPERIORITY||Mean Difference (Net)|13.79692|STANDARD_ERROR_OF_MEAN|808.862||0.9864081|TWO_SIDED|95.0|-1581.244|1608.838||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|t-test, 2 sided|||Unadjusted mean difference, 6 months after trial enrollment||1608.838|-1581.244|0.9864081
72580449|NCT03718832|144690416|SUPERIORITY||Mean Difference (Net)|119.3302|STANDARD_ERROR_OF_MEAN|885.2058||0.8929133|TWO_SIDED|95.0|-1627.128|1865.789||Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|Regression, Linear|||Adjusted mean difference for full controls, 6 months after trial enrollment||1865.789|-1627.128|0.8929133
72580450|NCT03718832|144690416|SUPERIORITY||Mean Difference (Net)|-1260.452|STANDARD_ERROR_OF_MEAN|1327.743||0.343724|TWO_SIDED|95.0|-3880.298|1359.393||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|t-test, 2 sided|||Unadjusted mean difference, 12 months after trial enrollment||1359.393|-3880.298|0.343724
72580451|NCT03718832|144690416|SUPERIORITY||Mean Difference (Net)|-1206.216|STANDARD_ERROR_OF_MEAN|1344.574||0.3709654|TWO_SIDED|95.0|-3860.887|1448.455||Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|Regression, Linear|||Adjusted mean difference for full controls, 12 months after trial enrollment||1448.455|-3860.887|0.3709654
72546209|NCT02637557|144622021|SUPERIORITY||LS Mean Difference|-0.06||||0.6985|TWO_SIDED|95.0|-0.363|0.243||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 6||0.243|-0.363|0.6985
72546210|NCT02637557|144622021|SUPERIORITY||LS Mean Difference|-0.373||||0.0163|TWO_SIDED|95.0|-0.677|-0.069||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 6||-0.069|-0.677|0.0163
72546211|NCT02637557|144622021|SUPERIORITY||LS Mean Difference|-0.345||||0.0273|TWO_SIDED|95.0|-0.652|-0.039||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 6||-0.039|-0.652|0.0273
72546212|NCT02637557|144622021|SUPERIORITY||LS Mean Difference|-0.056||||0.7187|TWO_SIDED|95.0|-0.362|0.25||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 7||0.250|-0.362|0.7187
72580452|NCT03718832|144690417|SUPERIORITY||Mean Difference (Net)|1290.605|STANDARD_ERROR_OF_MEAN|732.2306||0.0795087|TWO_SIDED|95.0|-153.3215|2734.532||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|t-test, 2 sided|||Unadjusted mean difference, 6 months after trial enrollment||2734.532|-153.3215|0.0795087
72580453|NCT03718832|144690417|SUPERIORITY||Mean Difference (Net)|1207.762|STANDARD_ERROR_OF_MEAN|874.6068||0.1689786|TWO_SIDED|95.0|-517.7854|2933.309||Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|Regression, Linear|||Adjusted mean difference for full controls, 6 months after trial enrollment||2933.309|-517.7854|0.1689786
72580454|NCT03718832|144690417|SUPERIORITY||Mean Difference (Net)|1209.35|STANDARD_ERROR_OF_MEAN|957.1006||0.2080145|TWO_SIDED|95.0|-679.1596|3097.86||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|t-test, 2 sided|||Unadjusted mean difference, 12 months after trial enrollment||3097.86|-679.1596|0.2080145
72546213|NCT02637557|144622021|SUPERIORITY||LS Mean Difference|-0.29||||0.064|TWO_SIDED|95.0|-0.596|0.017||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 7||0.017|-0.596|0.0640
72546214|NCT02637557|144622021|SUPERIORITY||LS Mean Difference|-0.484||||0.0023|TWO_SIDED|95.0|-0.793|-0.175||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 7||-0.175|-0.793|0.0023
72546215|NCT02637557|144622021|SUPERIORITY||LS Mean Difference|-0.079||||0.6033|TWO_SIDED|95.0|-0.378|0.22||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 8||0.220|-0.378|0.6033
72546216|NCT02637557|144622021|SUPERIORITY||LS Mean Difference|-0.35||||0.0222|TWO_SIDED|95.0|-0.65|-0.05||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 8||-0.050|-0.650|0.0222
72546217|NCT02637557|144622021|SUPERIORITY||LS Mean Difference|-0.482||||0.0019|TWO_SIDED|95.0|-0.785|-0.18||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 8||-0.180|-0.785|0.0019
72546218|NCT02637557|144622022|SUPERIORITY||LS Mean Difference|0.143||||0.1922|TWO_SIDED|95.0|-0.072|0.357||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 1||0.357|-0.072|0.1922
72546219|NCT02637557|144622022|SUPERIORITY||LS Mean Difference|0.072||||0.5091|TWO_SIDED|95.0|-0.143|0.288||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 1||0.288|-0.143|0.5091
72546220|NCT02637557|144622022|SUPERIORITY||LS Mean Difference|0.037||||0.7394|TWO_SIDED|95.0|-0.181|0.254||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 1||0.254|-0.181|0.7394
72546221|NCT02637557|144622022|SUPERIORITY||LS Mean Difference|0.073||||0.5845|TWO_SIDED|95.0|-0.189|0.334||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 2||0.334|-0.189|0.5845
72546222|NCT02637557|144622022|SUPERIORITY||LS Mean Difference|-0.034||||0.7959|TWO_SIDED|95.0|-0.296|0.228||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 2||0.228|-0.296|0.7959
72546223|NCT02637557|144622022|SUPERIORITY||LS Mean Difference|-0.015||||0.9086|TWO_SIDED|95.0|-0.28|0.249||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 2||0.249|-0.280|0.9086
72546224|NCT02637557|144622022|SUPERIORITY||LS Mean Difference|-0.08||||0.5334|TWO_SIDED|95.0|-0.333|0.173||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 3||0.173|-0.333|0.5334
72546225|NCT02637557|144622022|SUPERIORITY||LS Mean Difference|-0.212||||0.102|TWO_SIDED|95.0|-0.466|0.042||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 3||0.042|-0.466|0.1020
72546226|NCT02637557|144622022|SUPERIORITY||LS Mean Difference|-0.357||||0.0066|TWO_SIDED|95.0|-0.613|-0.1||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 3||-0.100|-0.613|0.0066
72546227|NCT02637557|144622022|SUPERIORITY||LS Mean Difference|-0.127||||0.3586|TWO_SIDED|95.0|-0.399|0.145||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 4||0.145|-0.399|0.3586
72546228|NCT02637557|144622022|SUPERIORITY||LS Mean Difference|-0.348||||0.0128|TWO_SIDED|95.0|-0.621|-0.075||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 4||-0.075|-0.621|0.0128
72546229|NCT02637557|144622022|SUPERIORITY||LS Mean Difference|-0.384||||0.0064|TWO_SIDED|95.0|-0.66|-0.109||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 4||-0.109|-0.660|0.0064
72412016|NCT00822510|144332137|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<.05
72412017|NCT00822510|144332139|SUPERIORITY_OR_OTHER|||||||0.79|TWO_SIDED|0.79|||||ANOVA|||||||.79
72546230|NCT02637557|144622022|SUPERIORITY||LS Mean Difference|-0.076||||0.6124|TWO_SIDED|95.0|-0.369|0.218||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 5||0.218|-0.369|0.6124
72546231|NCT02637557|144622022|SUPERIORITY||LS Mean Difference|-0.223||||0.1365|TWO_SIDED|95.0|-0.518|0.071||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 5||0.071|-0.518|0.1365
72546232|NCT02637557|144622022|SUPERIORITY||LS Mean Difference|-0.355||||0.0193|TWO_SIDED|95.0|-0.652|-0.058||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 5||-0.058|-0.652|0.0193
72546233|NCT02637557|144622022|SUPERIORITY||LS Mean Difference|-0.037||||0.8046|TWO_SIDED|95.0|-0.333|0.258||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 6||0.258|-0.333|0.8046
72546234|NCT02637557|144622022|SUPERIORITY||LS Mean Difference|-0.319||||0.035|TWO_SIDED|95.0|-0.616|-0.023||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 6||-0.023|-0.616|0.0350
72546235|NCT02637557|144622022|SUPERIORITY||LS Mean Difference|-0.392||||0.0105|TWO_SIDED|95.0|-0.691|-0.093||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 6||-0.093|-0.691|0.0105
72546236|NCT02637557|144622022|SUPERIORITY||LS Mean Difference|-0.094||||0.5482|TWO_SIDED|95.0|-0.403|0.214||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 7||0.214|-0.403|0.5482
72580455|NCT03718832|144690417|SUPERIORITY||Mean Difference (Net)|1258.587|STANDARD_ERROR_OF_MEAN|1077.807||0.2445904|TWO_SIDED|95.0|-869.3893|3386.563||Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|Regression, Linear|||Adjusted mean difference for full controls, 12 months after trial enrollment||3386.563|-869.3893|0.2445904
72580456|NCT03718832|144690418|SUPERIORITY||Mean Difference (Net)|2.035245|STANDARD_ERROR_OF_MEAN|0.1415551|<|0.001|TWO_SIDED|95.0|1.757075|2.313415||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|t-test, 2 sided|||Unadjusted mean difference, 6 months after trial enrollment||2.313415|1.757075|<0.001
72546237|NCT02637557|144622022|SUPERIORITY||LS Mean Difference|-0.377||||0.017|TWO_SIDED|95.0|-0.687|-0.068||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 7||-0.068|-0.687|0.0170
72546238|NCT02637557|144622022|SUPERIORITY||LS Mean Difference|-0.469||||0.0034|TWO_SIDED|95.0|-0.781|-0.157||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 7||-0.157|-0.781|0.0034
72546239|NCT02637557|144622022|SUPERIORITY||LS Mean Difference|-0.093||||0.5346|TWO_SIDED|95.0|-0.388|0.202||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 8||0.202|-0.388|0.5346
72546240|NCT02637557|144622022|SUPERIORITY||LS Mean Difference|-0.336||||0.0262|TWO_SIDED|95.0|-0.632|-0.04||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 8||-0.040|-0.632|0.0262
72412018|NCT00822510|144332140|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED|0.001|||||ANOVA|||||||.001
72412019|NCT00822510|144332141|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED|0.001|||||ANOVA|||||||.001
72546241|NCT02637557|144622022|SUPERIORITY||LS Mean Difference|-0.545||||0.0004|TWO_SIDED|95.0|-0.843|-0.246||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 8||-0.246|-0.843|0.0004
72546242|NCT02637557|144622023|SUPERIORITY||LS Mean Difference|0.098||||0.3007|TWO_SIDED|95.0|-0.088|0.284||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 1||0.284|-0.088|0.3007
72546243|NCT02637557|144622023|SUPERIORITY||LS Mean Difference|0.143||||0.1295|TWO_SIDED|95.0|-0.042|0.328||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 1||0.328|-0.042|0.1295
72546244|NCT02637557|144622023|SUPERIORITY||LS Mean Difference|-0.028||||0.7671|TWO_SIDED|95.0|-0.216|0.159||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 1||0.159|-0.216|0.7671
72546245|NCT02637557|144622023|SUPERIORITY||LS Mean Difference|0.01||||0.9308|TWO_SIDED|95.0|-0.217|0.238||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 2||0.238|-0.217|0.9308
72412020|NCT00822510|144332142|SUPERIORITY_OR_OTHER|||||||0.71|TWO_SIDED|0.71|||||ANOVA|||||||.71
72412021|NCT00822510|144332143|SUPERIORITY_OR_OTHER|||||||0.01|TWO_SIDED|0.01|||||ANOVA|||||||.01
72546246|NCT02637557|144622023|SUPERIORITY||LS Mean Difference|0.051||||0.6595|TWO_SIDED|95.0|-0.176|0.277||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 2||0.277|-0.176|0.6595
72580457|NCT03718832|144690418|SUPERIORITY||Mean Difference (Net)|2.0087|STANDARD_ERROR_OF_MEAN|0.1395364|<|0.001|TWO_SIDED|95.0|1.734473|2.282927||"Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05.~Heteroskedasticity-robust standard errors."|Regression, Linear|||Adjusted mean difference for full controls, 6 months after trial enrollment||2.282927|1.734473|<0.001
72546247|NCT02637557|144622023|SUPERIORITY||LS Mean Difference|-0.127||||0.2771|TWO_SIDED|95.0|-0.356|0.102||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 2||0.102|-0.356|0.2771
72546248|NCT02637557|144622023|SUPERIORITY||LS Mean Difference|-0.203||||0.0887|TWO_SIDED|95.0|-0.436|0.031||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 3||0.031|-0.436|0.0887
72580458|NCT03718832|144690418|SUPERIORITY||Mean Difference (Net)|1.619982|STANDARD_ERROR_OF_MEAN|0.2663507|<|0.001|TWO_SIDED|95.0|1.096575|2.143388||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|t-test, 2 sided|||Unadjusted mean difference, 12 months after trial enrollment.||2.143388|1.096575|<0.001
72546249|NCT02637557|144622023|SUPERIORITY||LS Mean Difference|-0.21||||0.0758|TWO_SIDED|95.0|-0.443|0.022||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 3||0.022|-0.443|0.0758
72546250|NCT02637557|144622023|SUPERIORITY||LS Mean Difference|-0.298||||0.0132|TWO_SIDED|95.0|-0.534|-0.063||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 3||-0.063|-0.534|0.0132
72546251|NCT02637557|144622023|SUPERIORITY||LS Mean Difference|-0.086||||0.4903|TWO_SIDED|95.0|-0.332|0.16||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 4||0.160|-0.332|0.4903
72546252|NCT02637557|144622023|SUPERIORITY||LS Mean Difference|-0.068||||0.5824|TWO_SIDED|95.0|-0.313|0.176||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 4||0.176|-0.313|0.5824
72546253|NCT02637557|144622023|SUPERIORITY||LS Mean Difference|-0.215||||0.0885|TWO_SIDED|95.0|-0.463|0.033||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 4||0.033|-0.463|0.0885
72546254|NCT02637557|144622023|SUPERIORITY||LS Mean Difference|-0.111||||0.3652|TWO_SIDED|95.0|-0.352|0.13||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 5||0.130|-0.352|0.3652
72546255|NCT02637557|144622023|SUPERIORITY||LS Mean Difference|-0.108||||0.3739|TWO_SIDED|95.0|-0.348|0.131||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 5||0.131|-0.348|0.3739
72546256|NCT02637557|144622023|SUPERIORITY||LS Mean Difference|-0.27||||0.0294|TWO_SIDED|95.0|-0.512|-0.027||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 5||-0.027|-0.512|0.0294
72546257|NCT02637557|144622023|SUPERIORITY||LS Mean Difference|-0.102||||0.4236|TWO_SIDED|95.0|-0.351|0.148||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 6||0.148|-0.351|0.4236
72546258|NCT02637557|144622023|SUPERIORITY||LS Mean Difference|-0.105||||0.4071|TWO_SIDED|95.0|-0.353|0.144||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 6||0.144|-0.353|0.4071
72546259|NCT02637557|144622023|SUPERIORITY||LS Mean Difference|-0.259||||0.0434|TWO_SIDED|95.0|-0.51|-0.008||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 6||-0.008|-0.510|0.0434
72546260|NCT02637557|144622023|SUPERIORITY||LS Mean Difference|-0.103||||0.4172|TWO_SIDED|95.0|-0.354|0.147||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 7||0.147|-0.354|0.4172
72546261|NCT02637557|144622023|SUPERIORITY||LS Mean Difference|-0.071||||0.5759|TWO_SIDED|95.0|-0.321|0.179||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 7||0.179|-0.321|0.5759
72546262|NCT02637557|144622023|SUPERIORITY||LS Mean Difference|-0.285||||0.0271|TWO_SIDED|95.0|-0.538|-0.033||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 7||-0.033|-0.538|0.0271
72580459|NCT03718832|144690418|SUPERIORITY||Mean Difference (Net)|1.559642|STANDARD_ERROR_OF_MEAN|0.2680774|<|0.001|TWO_SIDED|95.0|1.032797|2.086488||"Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05.~Heteroskedasticity-robust standard errors."|Regression, Linear|||Adjusted mean difference for full controls, 12 months after trial enrollment.||2.086488|1.032797|<0.001
72580460|NCT03718832|144690419|SUPERIORITY||Mean Difference (Net)|1.881776|STANDARD_ERROR_OF_MEAN|0.1057965|<|0.001|TWO_SIDED|95.0|1.673875|2.089677||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|t-test, 2 sided|||Unadjusted mean difference, 6 months after trial enrollment.||2.089677|1.673875|<0.001
72580461|NCT03718832|144690419|SUPERIORITY||Mean Difference (Net)|1.868221|STANDARD_ERROR_OF_MEAN|0.1036609|<|0.001|TWO_SIDED|95.0|1.664499|2.071943||"Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05.~Heteroskedasticity-robust standard errors."|Regression, Linear|||Adjusted mean difference for full controls, 6 months after trial enrollment.||2.071943|1.664499|<0.001
72546263|NCT02637557|144622023|SUPERIORITY||LS Mean Difference|-0.14||||0.2804|TWO_SIDED|95.0|-0.395|0.115||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 8||0.115|-0.395|0.2804
72546264|NCT02637557|144622023|SUPERIORITY||LS Mean Difference|-0.218||||0.0913|TWO_SIDED|95.0|-0.472|0.035||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 8||0.035|-0.472|0.0913
72546265|NCT02637557|144622023|SUPERIORITY||LS Mean Difference|-0.38||||0.0039|TWO_SIDED|95.0|-0.637|-0.123||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 8||-0.123|-0.637|0.0039
72546266|NCT02637557|144622024|SUPERIORITY||LS Mean Difference|0.128||||0.1902|TWO_SIDED|95.0|-0.064|0.319||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 1||0.319|-0.064|0.1902
72546267|NCT02637557|144622024|SUPERIORITY||LS Mean Difference|0.1||||0.3021|TWO_SIDED|95.0|-0.091|0.292||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 1||0.292|-0.091|0.3021
72546268|NCT02637557|144622024|SUPERIORITY||LS Mean Difference|-0.028||||0.775|TWO_SIDED|95.0|-0.221|0.165||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 1||0.165|-0.221|0.7750
72546269|NCT02637557|144622024|SUPERIORITY||LS Mean Difference|0.099||||0.4022|TWO_SIDED|95.0|-0.133|0.33||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 2||0.330|-0.133|0.4022
72546270|NCT02637557|144622024|SUPERIORITY||LS Mean Difference|0.062||||0.5971|TWO_SIDED|95.0|-0.169|0.293||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 2||0.293|-0.169|0.5971
72546271|NCT02637557|144622024|SUPERIORITY||LS Mean Difference|-0.045||||0.7024|TWO_SIDED|95.0|-0.279|0.188||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 2||0.188|-0.279|0.7024
72546272|NCT02637557|144622024|SUPERIORITY||LS Mean Difference|-0.115||||0.3173|TWO_SIDED|95.0|-0.342|0.111||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 3||0.111|-0.342|0.3173
72546273|NCT02637557|144622024|SUPERIORITY||LS Mean Difference|-0.151||||0.1906|TWO_SIDED|95.0|-0.378|0.076||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 3||0.076|-0.378|0.1906
72546274|NCT02637557|144622024|SUPERIORITY||LS Mean Difference|-0.183||||0.1177|TWO_SIDED|95.0|-0.412|0.046||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 3||0.046|-0.412|0.1177
72546275|NCT02637557|144622024|SUPERIORITY||LS Mean Difference|-0.05||||0.6936|TWO_SIDED|95.0|-0.297|0.198||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 4||0.198|-0.297|0.6936
72546276|NCT02637557|144622024|SUPERIORITY||LS Mean Difference|-0.096||||0.4466|TWO_SIDED|95.0|-0.343|0.152||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 4||0.152|-0.343|0.4466
72546277|NCT02637557|144622024|SUPERIORITY||LS Mean Difference|-0.155||||0.2225|TWO_SIDED|95.0|-0.405|0.095||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 4||0.095|-0.405|0.2225
72546278|NCT02637557|144622024|SUPERIORITY||LS Mean Difference|-0.052||||0.6764|TWO_SIDED|95.0|-0.297|0.193||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 5||0.193|-0.297|0.6764
72546279|NCT02637557|144622024|SUPERIORITY||LS Mean Difference|-0.061||||0.6243|TWO_SIDED|95.0|-0.306|0.184||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 5||0.184|-0.306|0.6243
72546280|NCT02637557|144622024|SUPERIORITY||LS Mean Difference|-0.156||||0.2151|TWO_SIDED|95.0|-0.403|0.091||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 5||0.091|-0.403|0.2151
72546281|NCT02637557|144622024|SUPERIORITY||LS Mean Difference|-0.096||||0.4611|TWO_SIDED|95.0|-0.351|0.16||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 6||0.160|-0.351|0.4611
72546282|NCT02637557|144622024|SUPERIORITY||LS Mean Difference|-0.139||||0.2849|TWO_SIDED|95.0|-0.394|0.116||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 6||0.116|-0.394|0.2849
72546283|NCT02637557|144622024|SUPERIORITY||LS Mean Difference|-0.228||||0.0833|TWO_SIDED|95.0|-0.485|0.03||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 6||0.030|-0.485|0.0833
72546284|NCT02637557|144622024|SUPERIORITY||LS Mean Difference|-0.017||||0.8955|TWO_SIDED|95.0|-0.277|0.242||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 7||0.242|-0.277|0.8955
72546285|NCT02637557|144622024|SUPERIORITY||LS Mean Difference|-0.052||||0.6916|TWO_SIDED|95.0|-0.312|0.207||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 7||0.207|-0.312|0.6916
72546286|NCT02637557|144622024|SUPERIORITY||LS Mean Difference|-0.159||||0.2345|TWO_SIDED|95.0|-0.421|0.103||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 7||0.103|-0.421|0.2345
72546287|NCT02637557|144622024|SUPERIORITY||LS Mean Difference|-0.043||||0.7466|TWO_SIDED|95.0|-0.304|0.218||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 8||0.218|-0.304|0.7466
72546288|NCT02637557|144622024|SUPERIORITY||LS Mean Difference|-0.176||||0.1843|TWO_SIDED|95.0|-0.437|0.084||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 8||0.084|-0.437|0.1843
72546289|NCT02637557|144622024|SUPERIORITY||LS Mean Difference|-0.267||||0.0471|TWO_SIDED|95.0|-0.531|-0.003||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 8||-0.003|-0.531|0.0471
72546290|NCT02637557|144622025|SUPERIORITY||LS Mean Difference|0.088||||0.3258|TWO_SIDED|95.0|-0.088|0.265||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 1||0.265|-0.088|0.3258
72546291|NCT02637557|144622025|SUPERIORITY||LS Mean Difference|0.084||||0.3483|TWO_SIDED|95.0|-0.092|0.261||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 1||0.261|-0.092|0.3483
72546292|NCT02637557|144622025|SUPERIORITY||LS Mean Difference|0.022||||0.8055|TWO_SIDED|95.0|-0.156|0.201||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 1||0.201|-0.156|0.8055
72546293|NCT02637557|144622025|SUPERIORITY||LS Mean Difference|0.103||||0.3627|TWO_SIDED|95.0|-0.119|0.326||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 2||0.326|-0.119|0.3627
72546294|NCT02637557|144622025|SUPERIORITY||LS Mean Difference|0.087||||0.4404|TWO_SIDED|95.0|-0.135|0.31||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 2||0.310|-0.135|0.4404
72546295|NCT02637557|144622025|SUPERIORITY||LS Mean Difference|0.001||||0.9939|TWO_SIDED|95.0|-0.224|0.226||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 2||0.226|-0.224|0.9939
72546296|NCT02637557|144622025|SUPERIORITY||LS Mean Difference|-0.128||||0.2716|TWO_SIDED|95.0|-0.356|0.1||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 3||0.100|-0.356|0.2716
72546297|NCT02637557|144622025|SUPERIORITY||LS Mean Difference|-0.116||||0.3175|TWO_SIDED|95.0|-0.345|0.112||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 3||0.112|-0.345|0.3175
72546298|NCT02637557|144622025|SUPERIORITY||LS Mean Difference|-0.252||||0.0325|TWO_SIDED|95.0|-0.483|-0.021||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 3||-0.021|-0.483|0.0325
72546299|NCT02637557|144622025|SUPERIORITY||LS Mean Difference|-0.169||||0.1769|TWO_SIDED|95.0|-0.415|0.077||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 4||0.077|-0.415|0.1769
72546300|NCT02637557|144622025|SUPERIORITY||LS Mean Difference|-0.188||||0.1343|TWO_SIDED|95.0|-0.434|0.058||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 4||0.058|-0.434|0.1343
72546301|NCT02637557|144622025|SUPERIORITY||LS Mean Difference|-0.295||||0.0203|TWO_SIDED|95.0|-0.544|-0.046||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 4||-0.046|-0.544|0.0203
72546302|NCT02637557|144622025|SUPERIORITY||LS Mean Difference|-0.152||||0.2543|TWO_SIDED|95.0|-0.415|0.11||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 5||0.110|-0.415|0.2543
72546303|NCT02637557|144622025|SUPERIORITY||LS Mean Difference|-0.142||||0.2892|TWO_SIDED|95.0|-0.405|0.121||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 5||0.121|-0.405|0.2892
72546304|NCT02637557|144622025|SUPERIORITY||LS Mean Difference|-0.306||||0.0243|TWO_SIDED|95.0|-0.571|-0.04||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 5||-0.040|-0.571|0.0243
72546305|NCT02637557|144622025|SUPERIORITY||LS Mean Difference|-0.059||||0.6471|TWO_SIDED|95.0|-0.312|0.194||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 6||0.194|-0.312|0.6471
72546306|NCT02637557|144622025|SUPERIORITY||LS Mean Difference|-0.106||||0.4123|TWO_SIDED|95.0|-0.359|0.148||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 6||0.148|-0.359|0.4123
72546307|NCT02637557|144622025|SUPERIORITY||LS Mean Difference|-0.278||||0.0338|TWO_SIDED|95.0|-0.534|-0.021||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 6||-0.021|-0.534|0.0338
72546308|NCT02637557|144622025|SUPERIORITY||LS Mean Difference|-0.095||||0.4841|TWO_SIDED|95.0|-0.362|0.172||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 7||0.172|-0.362|0.4841
72546309|NCT02637557|144622025|SUPERIORITY||LS Mean Difference|-0.152||||0.2627|TWO_SIDED|95.0|-0.419|0.115||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 7||0.115|-0.419|0.2627
72546310|NCT02637557|144622025|SUPERIORITY||LS Mean Difference|-0.311||||0.0241|TWO_SIDED|95.0|-0.581|-0.041||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 7||-0.041|-0.581|0.0241
72546311|NCT02637557|144622025|SUPERIORITY||LS Mean Difference|-0.093||||0.4881|TWO_SIDED|95.0|-0.355|0.17||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 8||0.170|-0.355|0.4881
72546312|NCT02637557|144622025|SUPERIORITY||LS Mean Difference|-0.164||||0.2205|TWO_SIDED|95.0|-0.427|0.099||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 8||0.099|-0.427|0.2205
72546313|NCT02637557|144622025|SUPERIORITY||LS Mean Difference|-0.433||||0.0015|TWO_SIDED|95.0|-0.699|-0.168||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 8||-0.168|-0.699|0.0015
72546314|NCT02637557|144622026|SUPERIORITY||LS Mean Difference|0.043||||0.6653|TWO_SIDED|95.0|-0.152|0.238||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 1||0.238|-0.152|0.6653
72546315|NCT02637557|144622026|SUPERIORITY||LS Mean Difference|0.15||||0.1327|TWO_SIDED|95.0|-0.046|0.345||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 1||0.345|-0.046|0.1327
72546316|NCT02637557|144622026|SUPERIORITY||LS Mean Difference|0.043||||0.6697|TWO_SIDED|95.0|-0.155|0.241||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 1||0.241|-0.155|0.6697
72546317|NCT02637557|144622026|SUPERIORITY||LS Mean Difference|0.021||||0.8598|TWO_SIDED|95.0|-0.21|0.251||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 2||0.251|-0.210|0.8598
72546318|NCT02637557|144622026|SUPERIORITY||LS Mean Difference|0.113||||0.3354|TWO_SIDED|95.0|-0.118|0.344||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 2||0.344|-0.118|0.3354
72546319|NCT02637557|144622026|SUPERIORITY||LS Mean Difference|0.055||||0.6429|TWO_SIDED|95.0|-0.179|0.289||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 2||0.289|-0.179|0.6429
72546320|NCT02637557|144622026|SUPERIORITY||LS Mean Difference|-0.101||||0.401|TWO_SIDED|95.0|-0.336|0.135||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 3||0.135|-0.336|0.4010
72412022|NCT01404312|144332144|NON_INFERIORITY|"Non-inferiority margin: 1.25 events per 100 person-years.~Sample size determination was based on the assumption of a primary endpoint rate of 2.0/100 person-years, with a one-sided 0.025 alpha level, and targeting at least 90% power. This required a sample size of approximately 2500. The sample size was adjusted upwards to account for loss to follow-up, interim monitoring, and to allow for subgroup analyses with reasonable power."|Incidence Rate Difference|-0.0231|||||TWO_SIDED|95.1|-0.346|0.3|||||"Estimate given as Incidence rate in Arm A - Incidence Rate in Arm B (negative favors Arm A).~Incidence rate units: Events per 100 person-years"|Mantel-Haenszel method used for estimating standardized incidence rate in each arm and incidence rate difference.||0.300|-0.346|
72412023|NCT01404312|144332145|SUPERIORITY||Risk Difference (RD)|-0.016||||0.073|TWO_SIDED|95.0|-0.035|0.002||Not adjusted for multiple comparisons.|Fisher Exact||Estimate given as: Proportion Arm A - Proportion Arm B|"Comparison of the proportion of participants with any SAE occurrence between arms A and B.~H0: Proportion of participants with SAE in Arm A = Proportion of participants with SAE in Arm B."||0.002|-0.035|0.073
72546321|NCT02637557|144622026|SUPERIORITY||LS Mean Difference|-0.129||||0.2821|TWO_SIDED|95.0|-0.364|0.106||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 3||0.106|-0.364|0.2821
72580462|NCT03718832|144690419|SUPERIORITY||Mean Difference (Net)|1.650879|STANDARD_ERROR_OF_MEAN|0.2057239|<|0.001|TWO_SIDED|95.0|1.246611|2.055147||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|t-test, 2 sided|||Unadjusted mean difference, 12 months after trial enrollment.||2.055147|1.246611|<0.001
72546322|NCT02637557|144622026|SUPERIORITY||LS Mean Difference|-0.149||||0.2189|TWO_SIDED|95.0|-0.388|0.089||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 3||0.089|-0.388|0.2189
72546323|NCT02637557|144622026|SUPERIORITY||LS Mean Difference|-0.093||||0.4717|TWO_SIDED|95.0|-0.346|0.161||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 4||0.161|-0.346|0.4717
72546324|NCT02637557|144622026|SUPERIORITY||LS Mean Difference|-0.096||||0.4572|TWO_SIDED|95.0|-0.349|0.158||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 4||0.158|-0.349|0.4572
72546325|NCT02637557|144622026|SUPERIORITY||LS Mean Difference|-0.165||||0.2064|TWO_SIDED|95.0|-0.422|0.092||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 4||0.092|-0.422|0.2064
72546326|NCT02637557|144622026|SUPERIORITY||LS Mean Difference|-0.088||||0.4932|TWO_SIDED|95.0|-0.339|0.164||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 5||0.164|-0.339|0.4932
72546327|NCT02637557|144622026|SUPERIORITY||LS Mean Difference|-0.069||||0.5897|TWO_SIDED|95.0|-0.321|0.183||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 5||0.183|-0.321|0.5897
72546328|NCT02637557|144622026|SUPERIORITY||LS Mean Difference|-0.166||||0.2014|TWO_SIDED|95.0|-0.421|0.089||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 5||0.089|-0.421|0.2014
72546329|NCT02637557|144622026|SUPERIORITY||LS Mean Difference|-0.044||||0.7384|TWO_SIDED|95.0|-0.304|0.215||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 6||0.215|-0.304|0.7384
72580463|NCT03718832|144690419|SUPERIORITY||Mean Difference (Net)|1.636306|STANDARD_ERROR_OF_MEAN|0.2052192|<|0.001|TWO_SIDED|95.0|1.232994|2.039618||"Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05.~Heteroskedasticity-robust standard errors."|Regression, Linear|||Adjusted mean difference for full controls, 12 months after trial enrollment.||2.039618|1.232994|<0.001
72580464|NCT03718832|144690420|SUPERIORITY||Mean Difference (Net)|0.1104533|STANDARD_ERROR_OF_MEAN|0.0769621||0.1519153|TWO_SIDED|95.0|-0.040785|0.2616915||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|t-test, 2 sided|||Unadjusted mean difference, 6 months after trial enrollment.||0.2616915|-0.040785|0.1519153
72546330|NCT02637557|144622026|SUPERIORITY||LS Mean Difference|-0.043||||0.7423|TWO_SIDED|95.0|-0.303|0.216||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 6||0.216|-0.303|0.7423
72546331|NCT02637557|144622026|SUPERIORITY||LS Mean Difference|-0.141||||0.2923|TWO_SIDED|95.0|-0.404|0.122||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 6||0.122|-0.404|0.2923
72546332|NCT02637557|144622026|SUPERIORITY||LS Mean Difference|-0.085||||0.5388|TWO_SIDED|95.0|-0.359|0.188||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 7||0.188|-0.359|0.5388
72546333|NCT02637557|144622026|SUPERIORITY||LS Mean Difference|0.008||||0.9565|TWO_SIDED|95.0|-0.266|0.281||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 7||0.281|-0.266|0.9565
72546334|NCT02637557|144622026|SUPERIORITY||LS Mean Difference|-0.099||||0.4848|TWO_SIDED|95.0|-0.376|0.179||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 7||0.179|-0.376|0.4848
72546335|NCT02637557|144622026|SUPERIORITY||LS Mean Difference|-0.164||||0.2523|TWO_SIDED|95.0|-0.445|0.117||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 8||0.117|-0.445|0.2523
72546336|NCT02637557|144622026|SUPERIORITY||LS Mean Difference|-0.112||||0.4356|TWO_SIDED|95.0|-0.393|0.17||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 8||0.170|-0.393|0.4356
72546337|NCT02637557|144622026|SUPERIORITY||LS Mean Difference|-0.199||||0.1706|TWO_SIDED|95.0|-0.485|0.086||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 8||0.086|-0.485|0.1706
72580465|NCT03718832|144690420|SUPERIORITY||Mean Difference (Net)|0.0594575|STANDARD_ERROR_OF_MEAN|0.0654489||0.3641254|TWO_SIDED|95.0|-0.0691675|0.1880824||"Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05.~Heteroskedasticity-robust standard errors."|Regression, Linear|||Adjusted mean difference for full controls, 6 months after trial enrollment.||0.1880824|-0.0691675|0.3641254
72546338|NCT02637557|144622027|SUPERIORITY||LS Mean Difference|-0.02||||0.7689|TWO_SIDED|95.0|-0.155|0.115||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||||0.115|-0.155|0.7689
72546339|NCT02637557|144622027|SUPERIORITY||LS Mean Difference|0.034||||0.6287|TWO_SIDED|95.0|-0.103|0.17||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||||0.170|-0.103|0.6287
72546340|NCT02637557|144622027|SUPERIORITY||LS Mean Difference|0.07||||0.3106|TWO_SIDED|95.0|-0.066|0.207||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||||0.207|-0.066|0.3106
72546341|NCT02637557|144622028|SUPERIORITY||LS Mean Difference|0.0||||0.9961|TWO_SIDED|95.0|-0.1|0.101||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||||0.101|-0.100|0.9961
72580466|NCT03718832|144690420|SUPERIORITY||Mean Difference (Net)|0.2062905|STANDARD_ERROR_OF_MEAN|0.1288363||0.1100186|TWO_SIDED|95.0|-0.0468859|0.4594669||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|t-test, 2 sided|||Unadjusted mean difference, 12 months after trial enrollment.||0.4594669|-0.0468859|0.1100186
72546342|NCT02637557|144622028|SUPERIORITY||LS Mean Difference|-0.008||||0.8829|TWO_SIDED|95.0|-0.109|0.094||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||||0.094|-0.109|0.8829
72546343|NCT02637557|144622028|SUPERIORITY||LS Mean Difference|0.1||||0.0527|TWO_SIDED|95.0|-0.001|0.201||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||||0.201|-0.001|0.0527
72546344|NCT04604184|144622052|OTHER||Risk Difference (RD)|-5.39||||0.3232|TWO_SIDED|95.0|-16.08|5.3|||Regression, Logistic|includes treatment, age, severity grade and creatinine at baseline, duration of symptoms before hospitalisation as covariates||||5.30|-16.08|0.3232
72546345|NCT04604184|144622053|OTHER||Risk Difference (RD)|-9.86||||0.1274|TWO_SIDED|95.0|-22.54|2.82|||Regression, Logistic|includes treatment, age, severity grade and creatinine at baseline, duration of symptoms before hospitalisation as covariates||||2.82|-22.54|0.1274
72546346|NCT04604184|144622054|OTHER||Risk Difference (RD)|2.66||||0.6828|TWO_SIDED|95.0|-10.11|15.43|||Regression, Logistic|includes treatment, age, severity grade and creatinine at baseline, duration of symptoms before hospitalisation as covariates||||15.43|-10.11|0.6828
72546347|NCT04604184|144622055|OTHER||Rate Ratio|0.67||||0.0445|TWO_SIDED|95.0|0.46|0.99|||Regression, Cox|Covariates are treatment, age, severity grade and creatinine at baseline and duration of symptoms before hospitalization||||0.99|0.46|0.0445
72546348|NCT04604184|144622056|OTHER||Mean Difference (Net)|-0.8|STANDARD_ERROR_OF_MEAN|1.35||0.5526|TWO_SIDED|95.0|-3.47|1.87|||ANCOVA|Fixed effects of treatment, age, severity grade and creatinine at baseline and duration of symptoms before hospitalisation as covariates|Difference = covariate adjusted BI 764198 - covariate adjusted Placebo|||1.87|-3.47|0.5526
72546349|NCT04604184|144622057|OTHER||Risk Difference (RD)|5.32||||0.0995|TWO_SIDED|95.0|-1.01|11.65|||Regression, Logistic|Includes treatment, age, severity grade and creatinine at baseline, and duration of symptoms before hospitalisation as covariates||Day 15||11.65|-1.01|0.0995
72546350|NCT04604184|144622057|OTHER||Risk Difference (RD)|6.06||||0.1992|TWO_SIDED|95.0|-3.19|15.31|||Regression, Logistic|Includes treatment, age, severity grade and creatinine at baseline, and duration of symptoms before hospitalisation as covariates||Day 29||15.31|-3.19|0.1992
72580467|NCT03718832|144690420|SUPERIORITY||Mean Difference (Net)|0.1162375|STANDARD_ERROR_OF_MEAN|0.1015839||0.2531303|TWO_SIDED|95.0|-0.0834025|0.3158775||"Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05.~Heteroskedasticity-robust standard errors."|Regression, Linear|||Adjusted mean difference for full controls, 12 months after trial enrollment.||0.3158775|-0.0834025|0.2531303
72546351|NCT04604184|144622057|OTHER||Risk Difference (RD)|8.93||||0.0709|TWO_SIDED|95.0|-0.76|18.62|||Regression, Logistic|Includes treatment, age, severity grade and creatinine at baseline, and duration of symptoms before hospitalisation as covariates||Day 60||18.62|-0.76|0.0709
72580468|NCT03718832|144690421|SUPERIORITY||Mean Difference (Net)|-0.0584644|STANDARD_ERROR_OF_MEAN|0.040837||0.152918|TWO_SIDED|95.0|-0.1387132|0.0217844||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|t-test, 2 sided|||Unadjusted mean difference, 6 months after trial enrollment||0.0217844|-0.1387132|0.152918
72546352|NCT04604184|144622057|OTHER||Risk Difference (RD)|10.35||||0.0412|TWO_SIDED|95.0|0.41|20.28|||Regression, Logistic|Includes treatment, age, severity grade and creatinine at baseline, and duration of symptoms before hospitalisation as covariates||Day 90||20.28|0.41|0.0412
72546353|NCT01711021|144622065|SUPERIORITY||Least Square (LS) mean difference|-5.87|||<|0.001|TWO_SIDED|95.0|-6.76|-4.97|||Mixed Models Analysis|Mixed model repeated measure (MMRM) analysis for SKAMP total score in Double-Blind period||||-4.97|-6.76|< 0.001
72412024|NCT01404312|144332146|SUPERIORITY||Risk Difference (RD)|-0.0058||||0.405|TWO_SIDED|95.0|-0.019|0.007||Not adjusted for multiple comparisons|Fisher Exact||Estimate given as: Proportion Arm A - Proportion Arm B|"Comparison of the proportion of participants with any targeted adverse event occurrence between arms A and B.~H0: Proportion of participants with a targeted adverse event in Arm A = Proportion of participants with a targeted adverse event in Arm B."||0.007|-0.019|0.405
72546354|NCT01711021|144622067|SUPERIORITY|||||||0.01|||||||Mixed Models Analysis|||||||0.01
72546355|NCT01844583|144622072|SUPERIORITY_OR_OTHER||LS Mean Ratio|1.14|||||TWO_SIDED|90.0|0.97|1.35|||||Estimates for each PK parameter were obtained using a mixed effects model of log (PK parameter) with fixed terms for the esomeprazole effect and random terms for participants within sequence.|||1.35|0.97|
72546356|NCT01844583|144622073|SUPERIORITY_OR_OTHER||LS Mean Ratio|1.25|||||TWO_SIDED|90.0|1.08|1.45|||||Estimates for each PK parameter were obtained using a mixed effects model of log (PK parameter) with fixed terms for the esomeprazole effect and random terms for participants within sequence.|||1.45|1.08|
72546357|NCT01844583|144622074|SUPERIORITY_OR_OTHER||LS Mean Ratio|1.28|||||TWO_SIDED|90.0|1.07|1.53|||||Estimates for each PK parameter were obtained using a mixed effects model of log (PK parameter) with fixed terms for the esomeprazole effect and random terms for participants within sequence.|||1.53|1.07|
72546358|NCT01844583|144622077|SUPERIORITY_OR_OTHER||LS Mean Ratio|1.03|||||TWO_SIDED|90.0|0.84|1.26|||||Estimates for each PK parameter were obtained using a mixed effects model of log (PK parameter) with fixed terms for the esomeprazole effect and random terms for participants within sequence.|||1.26|0.84|
72546359|NCT01844583|144622078|SUPERIORITY_OR_OTHER||LS Mean Ratio|0.51|||||TWO_SIDED|90.0|0.41|0.62|||||Estimates for each PK parameter were obtained using a mixed effects model of log (PK parameter) with fixed terms for the esomeprazole effect and random terms for participants within sequence.|||0.62|0.41|
72546360|NCT01844583|144622079|SUPERIORITY_OR_OTHER||LS Mean Ratio|0.53|||||TWO_SIDED|90.0|0.41|0.7|||||Estimates for each PK parameter were obtained using a mixed effects model of log (PK parameter) with fixed terms for the esomeprazole effect and random terms for participants within sequence.|||0.70|0.41|
72546361|NCT01625377|144622085|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-14.34|||<|0.0001|TWO_SIDED|95.0|-21.34|-7.34|||ANCOVA|||||-7.34|-21.34|<0.0001
72546362|NCT03513497|144622098|SUPERIORITY|||||||0.3|||||||Wilcoxon (Mann-Whitney)|||||||0.3
72546363|NCT03513497|144622099|SUPERIORITY|||||||0.5|||||||Wilcoxon (Mann-Whitney)|||||||0.5
72546364|NCT03513497|144622100|SUPERIORITY|||||||0.6|||||||Wilcoxon (Mann-Whitney)|||||||0.6
72546365|NCT03513497|144622101|SUPERIORITY|||||||0.5|||||||Wilcoxon (Mann-Whitney)|||||||0.5
72546366|NCT01412541|144622104|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The evaluable sample size required for 90% power is 150 (50 Control plus 100 Test). This endpoint is not the sample-size driver of the study. Randomization of 476 subjects is expected to provide at least 405 evaluable subjects, after adjustment for up to 15% censoring) and approximately 99% power.||||||0.025|||||||Farrington and Manning|||"To assess if proportion of subjects with at least one safety event\* in the Test group is inferior or not inferior to that of Control group through 12-months Post index procedure (PPI) H0: The proportion of subjects with safety events in the Test group through 12-months PPI is clinically inferior to that of the Control group.~H1: The proportion of subjects with safety events in the Test group through 12-months PPI is clinically non-inferior to that of the Control group."||||0.025
72546367|NCT01412541|144622105|EQUIVALENCE|The statistical analysis is a likelihood ratio chi-square test for inequality of binomial proportions; the test is a two-sided test at α=0.05. The response variable in each subject will be the presence or absence of at least one efficacy event from the time following the index procedure through 12 months. The study evaluable sample size required for 90% power is approximately 405 subjects. After adjustment for 15% censoring through 12 months, the study size is 476.||||||0.05|||||||Chi-squared|The statistical analysis is a likelihood ratio chi-square test for inequality of binomial proportions; the test is a two-sided test.||"To assess whether the proportion of subjects with at least one efficacy event\* in the Test group is equal or not to that of Control group through 12-months post-index procedure.~H0: The proportion of subjects with efficacy events in the Control group through 12-months post-index procedure is equal to that of the Test group.~H1: The proportion of subjects with efficacy events in the Control group through 12-months post-index procedure is not equal to that of the Test group."||||0.05
72546368|NCT03294538|144622122|EQUIVALENCE|If the adjusted 90% confidence interval on the difference between proportions of participants considered Responders in the generic estradiol vaginal cream group and the Estrace Vaginal Cream group was contained within the equivalence range \[-0.20, +0.20\], then treatment with generic estradiol vaginal cream and treatment with Estrace Vaginal Cream were considered therapeutically equivalent.|Odds Ratio (OR)|0.7|||||TWO_SIDED|90.0|-5.8|7.2||||||Therapeutic equivalence of the generic estradiol vaginal cream group to the Estrace Vaginal Cream group based on the primary endpoint was evaluated in the PP population.||7.2|-5.8|
72546369|NCT03294538|144622123|SUPERIORITY|The proportion of participants considered as Responders in the generic estradiol vaginal cream group and the Estrace Vaginal Cream group were each compared to the proportion of Responders in the vehicle vaginal cream group. If both the generic estradiol vaginal cream group and the Estrace Vaginal Cream group demonstrated a statistically significant greater proportion of Responders than the vehicle vaginal cream group, then superiority was concluded.|Odds Ratio (OR)|19.9|||<|0.0001|||||||Cochran-Mantel-Haenszel|||Superiority of the generic estradiol vaginal cream group and the Estrace Vaginal Cream group to the vehicle vaginal cream group based on the primary endpoint was evaluated in the mITT population.||||<0.0001
72546370|NCT03294538|144622123|SUPERIORITY|The proportion of participants considered as Responders in the generic estradiol vaginal cream group and the Estrace Vaginal Cream group were each compared to the proportion of Responders in the vehicle vaginal cream group. If both the generic estradiol vaginal cream group and the Estrace Vaginal Cream group demonstrated a statistically significant greater proportion of Responders than the vehicle vaginal cream group, then superiority was concluded.|Odds Ratio (OR)|20.2|||<|0.0001|||||||Cochran-Mantel-Haenszel|||Superiority of the generic estradiol vaginal cream group and the Estrace Vaginal Cream group to the vehicle vaginal cream group based on the primary endpoint was evaluated in the mITT population.||||<0.0001
72546371|NCT03294538|144622124|EQUIVALENCE|If the adjusted 90% confidence interval on the difference between proportions of participants considered Treatment Success in the generic estradiol vaginal cream group and the Estrace Vaginal Cream group was contained within the equivalence range \[-0.20, +0.20\], then treatment with generic estradiol vaginal cream and treatment with Estrace Vaginal Cream were considered therapeutically equivalent.|Odds Ratio (OR)|-1.4|||||TWO_SIDED|90.0|-9.0|6.2||||||Therapeutic equivalence of the generic estradiol vaginal cream group to the Estrace Vaginal Cream group based on the secondary endpoint was evaluated in the PP population.||6.2|-9.0|
72546372|NCT03294538|144622125|SUPERIORITY|The proportion of participants considered as Treatment Success in the generic estradiol vaginal cream group and the Estrace Vaginal Cream group were each compared to the proportion of Treatment Success in the vehicle vaginal cream group. If both the generic estradiol vaginal cream group and the Estrace Vaginal Cream group demonstrated a statistically significant greater proportion of Treatment Success than the vehicle vaginal cream group, then superiority was concluded.|Odds Ratio (OR)|4.9||||0.2897|||||||Cochran-Mantel-Haenszel|||Superiority of the generic estradiol vaginal cream group and the Estrace Vaginal Cream group to the vehicle vaginal cream group based on the secondary endpoint was evaluated in the mITT population.||||0.2897
72552658|NCT04459585|144636126|OTHER|Least squares (LS) means were calculated from an analysis of variance (ANOVA) model on log-transformed scale. The LS means for each treatment were back transformed from the log scale to provide estimates of the geometric means (GMS). The ratio (%) of GMS was calculated and 90% CIs for the ratio (%) of GMS were presented.|Ratio (%) of Geometric LS Mean|111.37|||||TWO_SIDED|90.0|78.51|157.97|||||For the comparison, the Dabigatran Etexilate + Quizartinib (Period 2) represents the numerator and Dabigatran Etexilate (Period 1) represents the denominator.|Statistical comparison was analyzed for Total Dabigatran.||157.97|78.51|
72552659|NCT04459585|144636126|OTHER|Least squares (LS) means were calculated from an analysis of variance (ANOVA) model on log-transformed scale. The LS means for each treatment were back transformed from the log scale to provide estimates of the geometric means (GMS). The ratio (%) of GMS was calculated and 90% CIs for the ratio (%) of GMS were presented.|Ratio (%) of Geometric LS Mean|111.08|||||TWO_SIDED|90.0|77.35|159.51|||||For the comparison, the Dabigatran Etexilate + Quizartinib (Period 2) represents the numerator and Dabigatran Etexilate (Period 1) represents the denominator.|Statistical comparison was analyzed for Free Dabigatran.||159.51|77.35|
72552660|NCT04459585|144636127|OTHER|Least squares (LS) means were calculated from an analysis of variance (ANOVA) model on log-transformed scale. The LS means for each treatment were back transformed from the log scale to provide estimates of the geometric means (GMS). The ratio (%) of GMS was calculated and 90% CIs for the ratio (%) of GMS were presented.|Ratio (%) of Geometric LS Mean|112.97|||||TWO_SIDED|90.0|79.38|160.79|||||For the comparison, the Dabigatran Etexilate + Quizartinib (Period 2) represents the numerator and Dabigatran Etexilate (Period 1) represents the denominator.|Statistical comparison was analyzed for Total Dabigatran.||160.79|79.38|
72552661|NCT04459585|144636127|OTHER|Least squares (LS) means were calculated from an analysis of variance (ANOVA) model on log-transformed scale. The LS means for each treatment were back transformed from the log scale to provide estimates of the geometric means (GMS). The ratio (%) of GMS was calculated and 90% CIs for the ratio (%) of GMS were presented.|Ratio (%) of Geometric LS Mean|110.72|||||TWO_SIDED|90.0|76.77|159.68|||||For the comparison, the Dabigatran Etexilate + Quizartinib (Period 2) represents the numerator and Dabigatran Etexilate (Period 1) represents the denominator.|Statistical comparison was analyzed for Free Dabigatran.||159.68|76.77|
72552662|NCT01061866|144636142|NON_INFERIORITY_OR_EQUIVALENCE|p less than or equal to 0.05, repeated measures ANOVA|Mean Difference (Final Values)|0.02|||<|0.02||||||p-value is non-adjusted for multiple comparisons|ANOVA|Was adjusted the degrees of freedom for the averaged test of significance.|The frequency of seizures at the beginning of the study and after treatment with thalidomide was contrasted in the same group patients.|Power=0.02||||<0.02
72552663|NCT00834756|144636143|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using PROC GLM procedures in SAS, analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Test/Ref Ratio of LS Means x 100|96.0||||||90.0|87.96|104.78|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||104.78|87.96|
72546373|NCT03294538|144622125|SUPERIORITY|The proportion of participants considered as Treatment Success in the generic estradiol vaginal cream group and the Estrace Vaginal Cream group were each compared to the proportion of Treatment Success in the vehicle vaginal cream group. If both the generic estradiol vaginal cream group and the Estrace Vaginal Cream group demonstrated a statistically significant greater proportion of Treatment Success than the vehicle vaginal cream group, then superiority was concluded.|Odds Ratio (OR)|3.9||||0.4949|||||||Cochran-Mantel-Haenszel|||Superiority of the generic estradiol vaginal cream group and the Estrace Vaginal Cream group to the vehicle vaginal cream group based on the primary endpoint was evaluated in the mITT population.||||0.4949
72546374|NCT03532009|144622135|SUPERIORITY|||||||0.426|||||||F-test|||The p-value was obtained by pooling the p-values from Chi-square tests performed on individual data sets using the F-distribution and reflects a global test of no difference in distribution of patients in the respective categories between SZC and placebo groups. The null hypothesis was that there is no difference between SZC and placebo in the distribution of percentage of patients in the 4 RAASi treatment categories. The hypothesis was tested at a significance level of 5%.||||0.426
72546375|NCT01288859|144622144|NON_INFERIORITY_OR_EQUIVALENCE|The results from LC-MS/MS analysis of parent polyphenols were analyzed and expressed as the absolute changes from the baseline to reduce possible effects of inter-subject fasting variability|Mean Difference (Final Values)|1.0|STANDARD_ERROR_OF_MEAN|0.1||0.02|TWO_SIDED|95.0|||||ANOVA|||||||0.02
72552664|NCT00834756|144636144|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using PROC GLM procedures in SAS, analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Test/Ref Ratio of LS Means x 100|98.63||||||90.0|92.34|105.35|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||105.35|92.34|
72546376|NCT01288859|144622145|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.9|STANDARD_ERROR_OF_MEAN|0.01||0.01|TWO_SIDED|95.0|||||ANOVA|||Statistical analysis was performed using the statistical package SPSS for Windows (version15). By the analysis of variance (ANOVA) for repeated measures the subjective time curves for all measured compounds were compared and tested for the effect of treatment and of time as factors. For all tests, following a significant main effect in the ANOVA, individual means were compared using the Bonferroni test (p \< 0.05). Results were considered significant at p \< 0.05.||||0.01
72546377|NCT01288859|144622146|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|0.01||0.04|TWO_SIDED|95.0|||||ANOVA|||||||0.04
72546378|NCT01006707|144622148|SUPERIORITY_OR_OTHER|||||||0.042|||||||ANOVA|||Results were considered significant at p\<0.05.||||0.042
72580469|NCT03718832|144690421|SUPERIORITY||Mean Difference (Net)|-0.0585771|STANDARD_ERROR_OF_MEAN|0.0304262||0.0548344|TWO_SIDED|95.0|-0.1183728|0.0012186||"Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05.~Heteroskedasticity-robust standard errors."|Regression, Linear|||Adjusted mean difference for full controls, 6 months after trial enrollment.||0.0012186|-0.1183728|0.0548344
72580470|NCT03718832|144690421|SUPERIORITY||Mean Difference (Net)|-0.1691027|STANDARD_ERROR_OF_MEAN|0.0673022||0.0123238|TWO_SIDED|95.0|-0.3013583|-0.036847||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|t-test, 2 sided|||Unadjusted mean difference, 12 months after trial enrollment.||-0.036847|-0.3013583|0.0123238
72580471|NCT03718832|144690421|SUPERIORITY||Mean Difference (Net)|-0.1701425|STANDARD_ERROR_OF_MEAN|0.0575065||0.0032534|TWO_SIDED|95.0|-0.2831584|-0.0571266||"Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05.~Heteroskedasticity-robust standard errors."|Regression, Linear|||Adjusted mean difference for full controls, 12 months after trial enrollment.||-0.0571266|-0.2831584|0.0032534
72580472|NCT03503669|144690438|SUPERIORITY||||||>|0.05|||||||Mixed Models Analysis|||||||>0.05
72580473|NCT03503669|144690439|SUPERIORITY|||||||0.008|||||||Mixed Models Analysis|||||||0.008
72412025|NCT01404312|144332147|SUPERIORITY||Odds Ratio (OR)|2.093|||||TWO_SIDED|95.0|1.315|3.332|||||"Estimate given as: Odds of being in higher category (more stringent management due to toxicity) for Arm B compared with arm A~Not adjusted for multiple comparisons."|"Odds ratio of being in higher category estimated from proportional odds model~H0: Odds ratio of being in higher category for Arm A vs Arm B = 1"||3.332|1.315|
72546379|NCT01006707|144622149|SUPERIORITY_OR_OTHER|||||||0.322|||||||ANOVA|||Results were considered significant at p\<0.05.||||0.322
72546380|NCT01006707|144622150|SUPERIORITY_OR_OTHER|||||||0.261|||||||ANOVA|||Results were considered significant at p\<0.05.||||0.261
72546381|NCT05034731|144622151|NON_INFERIORITY|Non-inferiority analyses were based on paired t-tests looking at the differences in speech scores calculated using the investigational speech scores minus the control speech scores. The primary efficacy analyses tested the null hypothesis (inferiority) that the mean of the paired differences in AzBio sentence scores in quite (remote fitting - in-office fitting) are less than or equal to -10 percentile points.|||||<|0.0001|||||||t-test, 1 sided|||||||<0.0001
72546382|NCT05034731|144622152|NON_INFERIORITY|Non-inferiority analyses were based on paired t-tests looking at the differences in speech scores calculated using the investigational speech scores minus the control speech scores. The primary efficacy analyses tested the null hypothesis (inferiority) that the mean of the paired differences in AzBio sentence scores in quite (remote fitting - in-office fitting) are less than or equal to -10 percentile points.|||||<|0.0001|||||||t-test, 1 sided|||||||<0.0001
72546383|NCT00283686|144622154|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.2||||0.52|TWO_SIDED|95.0|-0.8|5.0||adjusted for age, sex, race, baseline estimated GFR, and clinical site.|Mixed Models Analysis|Test for differences between treatment groups over time.||||5.0|-0.8|0.52
72546384|NCT00283686|144622154|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.0||||0.006|TWO_SIDED|95.0|-1.6|-0.2||adjusted for age, sex, race, baseline estimated GFR, and clinical site.|Mixed Models Analysis|Testing differences between blood pressure groups over time||||-0.2|-1.6|0.006
72546385|NCT00283686|144622155|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.1||||0.52|TWO_SIDED|95.0|-0.6|0.3||adjusting for age, sex, race, and clinical site|Mixed Models Analysis|Testing for differences in treatment over time (differences in slopes over time).||||0.3|-0.6|0.52
72580474|NCT03503669|144690440|SUPERIORITY||||||>|0.05|||||||Mixed Models Analysis|||||||>0.05
72580475|NCT03503669|144690441|SUPERIORITY||||||>|0.05|||||||Mixed Models Analysis|||||||>0.05
72580476|NCT03503669|144690442|SUPERIORITY||||||>|0.05|||||||Mixed Models Analysis|||||||>0.05
72580477|NCT03288714|144690453|SUPERIORITY|||||||0.814|||||||Fisher Exact|The proportion of patients is compared across treatment groups using Fisher's Exact.||Null hypothesis is that the active sTMS treatment group does not differ from the sham group with respect to the proportion of patients with clinical response at Week 6.||||.814
72580478|NCT03288714|144690454|SUPERIORITY|||||||0.872|||||||ANCOVA|P-value is from analysis of covariance adjusting for baseline.||Null hypothesis is that the active sTMS treatment group does not differ from the sham group with respect to the proportion of patients with clinical response at Week 6.||||.872
72580479|NCT03288714|144690455|SUPERIORITY|||||||0.641|||||||ANCOVA|P-value is from analysis of covariance adjusting for baseline.||The null hypothesis is that the active sTMS treatment group does not differ||||.641
72580480|NCT03288714|144690456|SUPERIORITY|||||||0.032||||||Alpha level: .05|ANCOVA|P-value is from analysis of covariance adjusting for baseline||||||.032
72580481|NCT03288714|144690457|SUPERIORITY|||||||0.015||||||Alpha level: .05|ANCOVA|P-value is from analysis of covariance adjusting for baseline||||||.015
72580482|NCT03288714|144690458|SUPERIORITY|||||||0.028||||||Alpha level: .05|Fisher Exact|The proportion of patients is compared across treatment groups using Fisher's Exact.||||||.028
72546386|NCT00283686|144622155|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.1||||0.55|TWO_SIDED|95.0|-0.3|0.6||adjusted for age, sex, race, and clinical site|Mixed Models Analysis|Testing for differences between groups over time (differences in slopes over time)||||0.6|-0.3|0.55
72546387|NCT00283686|144622156|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.7||||0.57|TWO_SIDED|95.0|-3.3|1.9|||Mixed Models Analysis|adjusting for age, sex, race, and clinical site||||1.9|-3.3|0.57
72546388|NCT00283686|144622156|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.1|||<|0.0001|TWO_SIDED|95.0|-8.5|-3.4|||Mixed Models Analysis|adjusting for age, sex, race, and clinical site||||-3.4|-8.5|<0.0001
72546389|NCT00283686|144622157|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.3||||0.18|TWO_SIDED|95.0|-3.1|0.6|||Mixed Models Analysis|adjusting for age, sex, race, and clinical site||||0.6|-3.1|0.18
72580483|NCT03749330|144690524|EQUIVALENCE|test of difference between pre and post|||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
72580484|NCT01870778|144690555|SUPERIORITY||Hazard Ratio (HR)|0.98||||0.3857|TWO_SIDED|95.0|0.83|1.15||Adjusted alpha p-value based on multiple testing procedure.|Log Rank|One-sided p-value||||1.15|0.83|0.3857
72580485|NCT01870778|144690556|SUPERIORITY||Hazard Ratio (HR)|0.89||||0.0968|TWO_SIDED|95.0|0.75|1.07||Adjusted p-value based on multiple testing procedure|Gehan's generalized Wilcoxon test|One-sided p-value||||1.07|0.75|0.0968
72580486|NCT01870778|144690557|SUPERIORITY||Hazard Ratio (HR)|0.94||||0.389|TWO_SIDED|95.0|0.81|1.08|||Log Rank|2-sided p-value||||1.08|0.81|0.3890
72580487|NCT01870778|144690558|SUPERIORITY|||||||0.2204||||||Based on multiple testing procedure|Wilcoxon rank sum test|One-sided p-value||||||0.2204
72580488|NCT01870778|144690559|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.2744|TWO_SIDED|95.0|0.88|1.07||Adjusted p-value based on multiple testing procedure|Log Rank|||||1.07|0.88|0.2744
72580489|NCT01870778|144690560|SUPERIORITY|||||||0.2103|||||||Wilcoxon rank sum test|2-sided p-value||||||0.2103
72580490|NCT01870778|144690561|SUPERIORITY||Hazard Ratio (HR)|1.08||||0.005|TWO_SIDED|95.0|1.02|1.14|||Log Rank|2-sided p-value||Exertional dyspnea||1.14|1.02|0.0050
72412026|NCT01404312|144332148|SUPERIORITY|||||||0.3078||||||Not adjusted for multiple comparisons|Log Rank|||H0: Survival curve Arm A = Survival curve Arm B||||0.3078
72546390|NCT00283686|144622157|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.2||||0.19|TWO_SIDED|95.0|-3.1|0.6|||Mixed Models Analysis|adjusting for age, sex, race, and clinical site||||0.6|-3.1|0.19
72546391|NCT00283686|144622158|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.088||||0.58|TWO_SIDED|95.0|-0.4|0.22|||Mixed Models Analysis|adjusted for age, sex, race, baseline estimated GFR, and clinical site|comparing the annual change over time between ACE/ARB and ACE alone|||0.22|-0.40|0.58
72546392|NCT00283686|144622158|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.6||||0.0002|TWO_SIDED|95.0|-0.91|-0.29|||Mixed Models Analysis|adjusted for age, sex, race, baseline estimated GFR, and clinical site|comparing annual change in LVMI between Low Blood Pressure and Standard Blood Pressure groups|||-0.29|-0.91|0.0002
72546393|NCT00283686|144622159|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.97||||0.29|TWO_SIDED|95.0|-2.55|8.5|||Mixed Models Analysis|adjusted for age, sex, race, baseline estimated GFR, and clinical site|difference in annual change in mL/min/1.73 m\^2 for ACE+ARB compared to ACE alone|||8.50|-2.55|0.29
72546394|NCT00283686|144622159|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.98||||0.73|TWO_SIDED|95.0|-4.54|6.5|||Mixed Models Analysis|adjusting for age, sex, race, baseline estimated GFR, and clinical site|difference in annual change mL/min/1.73 m\^2 between low and standard blood pressure groups|||6.50|-4.54|0.73
72546395|NCT00283686|144622160|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.71||||0.0228|TWO_SIDED|95.0|0.53|0.95|||Regression, Cox|adjusting for age, sex, race, and clinical site||||0.95|0.53|0.0228
72546396|NCT00283686|144622160|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.93||||0.59|TWO_SIDED|95.0|0.7|1.22|||Regression, Cox|adjusting for age, sex, race, and clinical site||||1.22|0.70|0.59
72546397|NCT00283686|144622161|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.016||||0.87|TWO_SIDED|95.0|-0.19|0.17|||Mixed Models Analysis|adjusting for age, sex, race, and clinical site||||0.17|-0.19|0.87
72546398|NCT00283686|144622161|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.13||||0.14|TWO_SIDED|95.0|-0.046|0.31|||Mixed Models Analysis|adjusting for age, sex, race, and clinical site||||0.31|-0.046|0.14
72546399|NCT00283686|144622162|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.25||||0.0221|TWO_SIDED|95.0|0.036|0.46|||Mixed Models Analysis|adjusting for age, sex, race, and clinical site||||0.46|0.036|0.0221
72546400|NCT00283686|144622162|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.23||||0.0339|TWO_SIDED|95.0|-0.44|-0.018|||Mixed Models Analysis|adjusting for age, sex, race, and clinical site||||-0.018|-0.44|0.0339
72546401|NCT02970669|144622163|SUPERIORITY||Ratio of Geometric Means (SacVal/Ena)|0.9456||||0.0895|TWO_SIDED|95.0|0.8863|1.0088|||ANCOVA|model for a log-scaled response with treatment group as a class variable and the baseline value in logarithmic scale as a continuous covariate.||||1.0088|0.8863|0.0895
72580491|NCT01870778|144690561|SUPERIORITY||Hazard Ratio (HR)|1.08||||0.0051|TWO_SIDED|95.0|1.02|1.14|||Log Rank|2-sided p-value||Orthopnea||1.14|1.02|0.0051
72580492|NCT01870778|144690561|SUPERIORITY||Hazard Ratio (HR)|1.0||||0.9962|TWO_SIDED|95.0|0.95|1.05|||Log Rank|2-sided p-value||Rales||1.05|0.95|0.9962
72580493|NCT01870778|144690561|SUPERIORITY||Hazard Ratio (HR)|1.08||||0.0196|TWO_SIDED|95.0|1.01|1.15|||Log Rank|2-sided p-value||Jugular venous pressure||1.15|1.01|0.0196
72580494|NCT01870778|144690561|SUPERIORITY||Hazard Ratio (HR)|1.04||||0.2158|TWO_SIDED|95.0|0.98|1.1|||Log Rank|2-sided p-value||Peripheral edema, pre-sacral edema||1.10|0.98|0.2158
72580495|NCT01870778|144690562|SUPERIORITY||Ratio of RLX030 to placebo|0.9401||||0.0209|TWO_SIDED|95.0|0.8921|0.9907|||Repeated measures model|||Day 2||0.9907|0.8921|0.0209
72580496|NCT01870778|144690562|SUPERIORITY||Ratio of RLX030 to placebo|0.898||||0.0034|TWO_SIDED|95.0|0.8358|0.9649|||Repeated measures model|||Day 5||0.9649|0.8358|0.0034
72580497|NCT01870778|144690562|SUPERIORITY||Ratio of RLX030 to placebo|0.9074||||0.0209|TWO_SIDED|95.0|0.8355|0.9854|||Repeated measures model|||Day 14||0.9854|0.8355|0.0209
72546402|NCT02970669|144622164|SUPERIORITY||Mean Difference (Net)|293.6||||0.6316|TWO_SIDED|95.0|-916.5|1503.8|||ANCOVA|model with treatment group as a class variable and the baseline value as a continuous covariate.||||1503.8|-916.5|0.6316
72546403|NCT02970669|144622166|SUPERIORITY||Mean Difference (Net)|2.038||||0.057|TWO_SIDED|95.0|-0.062|4.138|||ANCOVA|model with treatment group as a class variable and the baseline value as a continuous covariate.||||4.138|-0.062|0.0570
72546404|NCT02970669|144622167|SUPERIORITY||Mean Difference (Net)|2.478||||0.0121|TWO_SIDED|95.0|0.553|4.403|||ANCOVA|model with treatment group as a class variable and the baseline value as a continuous covariate.||||4.403|0.553|0.0121
72546405|NCT00249821|144622175|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||ANCOVA|||"Month 12: Analysis of co-variance (ANCOVA) method with covariates height and age at baseline was used to calculate presented p-value."||||0.001
72546406|NCT00249821|144622176|SUPERIORITY_OR_OTHER|||||||0.012||95.0|||||ANCOVA|||"Change at Month 6: ANCOVA method with covariates height and age at baseline was used to calculate presented p-value."||||0.012
72546407|NCT00249821|144622176|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||ANCOVA|||"Change at Month 12: ANCOVA method with covariates height and age at baseline was used to calculate presented p-value."||||0.002
72546408|NCT00249821|144622177|SUPERIORITY_OR_OTHER|||||||0.022||95.0|||||ANCOVA|||"Month 6: ANCOVA method with covariates height and age at baseline was used to calculate presented p-value."||||0.022
72546409|NCT00249821|144622177|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||ANCOVA|||"Month 12: ANCOVA method with covariates height and age at baseline was used to calculate presented p-value."||||0.002
72546410|NCT00249821|144622178|SUPERIORITY_OR_OTHER|||||||0.029||95.0|||||ANCOVA|||"Change at Month 6: ANCOVA method with covariates height and age at baseline was used to calculate presented p-value."||||0.029
72546411|NCT00249821|144622179|SUPERIORITY_OR_OTHER|||||||0.972||95.0|||||ANCOVA|||"Change at Month 12: ANCOVA method with covariates height and age at baseline was used to calculate presented p-value."||||0.972
72546412|NCT00249821|144622180|SUPERIORITY_OR_OTHER|||||||0.058||95.0|||||ANCOVA|||"Month 6: ANCOVA method with covariates height and age at baseline was used to calculate presented p-value."||||0.058
72546413|NCT00249821|144622180|SUPERIORITY_OR_OTHER|||||||0.026||95.0|||||ANCOVA|||"Month 12: ANCOVA method with covariates height and age at baseline was used to calculate presented p-value."||||0.026
72546414|NCT00249821|144622181|SUPERIORITY_OR_OTHER|||||||0.793||95.0|||||ANCOVA|||"Month 6: ANCOVA method with covariates height and age at baseline was used to calculate presented p-value."||||0.793
72546415|NCT00249821|144622181|SUPERIORITY_OR_OTHER|||||||0.055||95.0|||||ANCOVA|||"Month 12: ANCOVA method with covariates height and age at baseline was used to calculate presented p-value."||||0.055
72546416|NCT02292238|144622193|OTHER||Mean Difference (Net)|1.8691|STANDARD_DEVIATION|5.5727||0.125|TWO_SIDED|||||Univariable (unadjusted) and a priori threshold for statistical significance is 0.05.|t-test, 2 sided|Equal variance t-test.||Power was calculated based on expected difference in change on the ADAS-Cog of 3 points between the treatment and control groups. Estimates based on using a two-sided alpha of 0.05 and a standard deviation of 4, enrolling 29 patients per group, (N = 58) suggest 80% power to detect a mean change of 3 between treatment and placebo.||||0.125
72546417|NCT02292238|144622194|OTHER|Univariable (unadjusted) and a priori threshold for statistical significance is 0.05.|Mean Difference (Net)|-0.00184|STANDARD_DEVIATION|0.0225||0.7529|TWO_SIDED||||||t-test, 2 sided|Equal variance t-test.||||||0.7529
72546418|NCT02292238|144622195|OTHER|Univariable (unadjusted) and a priori threshold for statistical significance is 0.05.|Mean Difference (Net)|-1.0636|STANDARD_DEVIATION|4.8176||0.3687|TWO_SIDED||||||t-test, 2 sided|Equal variance t-test.||||||0.3687
72546419|NCT02292238|144622196|OTHER||Mean Difference (Net)|1.8203|STANDARD_DEVIATION|13.8988||0.485|TWO_SIDED||||||t-test, 2 sided|Equal variance t-test.||||||0.4850
72546420|NCT02292238|144622197|OTHER||Mean Difference (Net)|0.1907|STANDARD_DEVIATION|0.3097||0.0337|TWO_SIDED|||||The a priori threshold for statistical significance is 0.05.|t-test, 2 sided|Equal variance t-test.||||||0.0337
72546421|NCT02292238|144622198|OTHER|Univariable (unadjusted) and a priori threshold for statistical significance is 0.05.|Mean Difference (Net)|-1.6161|STANDARD_DEVIATION|5.6812||0.315|TWO_SIDED||||||t-test, 2 sided|Equal variance t-test.||||||0.315
72546422|NCT00494806|144622203|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.7279|STANDARD_ERROR_OF_MEAN|0.15|<|0.05||95.0|0.3174|1.1383|||t-test, 2 sided|df = 64|Relative risk not calculated.|"No differences in time to first flatus between the rocking and non rocking groups is the null hypothesis.~Sample size calculations by setting the criterion for significance at .05, two-tailed test (an effect in either directions was accepted), and power at .80. A total sample of 54 participants was determined necessary to yield statistically significant results (27 in Group A and 27 in Group B)."||1.1383|0.3174|<0.05
72546423|NCT00814320|144622204|SUPERIORITY_OR_OTHER_LEGACY||Poisson|0.025|||<|0.0001|ONE_SIDED|99.0||0.046||Testing the null hypothesis of 1 VASBI/year against a one-sided alternative at the 0.01 level of statistical significance.|Poisson|||For SC Administration of IGIV, 10%, with rHuPH20 after ramp-up, only||0.046||<0.0001
72546424|NCT00491504|144622270|SUPERIORITY_OR_OTHER_LEGACY|||||||0.625|||||||ANCOVA|An analysis of covariance (ANCOVA) model was used with treatment as effect and Baseline as a covariate.||||||0.625
72546425|NCT03387033|144622281|OTHER||||||<|0.005|||||||Paired t-test|||||||<0.005
72546426|NCT03387033|144622282|OTHER||||||<|0.05|||||||Paired t-test|||||||<0.05
72546427|NCT03387033|144622283|OTHER||||||<|0.05|||||||Paired t-test|||||||<0.05
72546428|NCT00601484|144622284|SUPERIORITY_OR_OTHER_LEGACY||Least squares (LS) mean difference|-1.36|STANDARD_ERROR_OF_MEAN|0.503|||TWO_SIDED|90.0|-2.203|-0.51||||||Analysis was based on analysis of covariance (ANCOVA) model with terms for treatment, age, gender, body mass index (BMI), baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||-0.510|-2.203|
72546429|NCT00601484|144622285|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.68|STANDARD_ERROR_OF_MEAN|0.41|||TWO_SIDED|90.0|-1.363|0.011||||||Week 2: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||0.011|-1.363|
72546430|NCT00601484|144622285|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.13|STANDARD_ERROR_OF_MEAN|0.498|||TWO_SIDED|90.0|-1.969|-0.297||||||Week 4: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||-0.297|-1.969|
72546431|NCT00601484|144622285|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.85|STANDARD_ERROR_OF_MEAN|0.559|||TWO_SIDED|90.0|-1.79|0.09||||||Week 10: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||0.090|-1.790|
72546432|NCT00601484|144622285|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.45|STANDARD_ERROR_OF_MEAN|0.538|||TWO_SIDED|90.0|-1.356|0.457||||||Week 16: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||0.457|-1.356|
72546433|NCT00601484|144622286|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-8.68|STANDARD_ERROR_OF_MEAN|6.727|||TWO_SIDED|90.0|-19.954|2.601||||||Week 2: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||2.601|-19.954|
72546434|NCT00601484|144622286|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-17.74|STANDARD_ERROR_OF_MEAN|8.47|||TWO_SIDED|90.0|-31.948|-3.523||||||Week 4: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||-3.523|-31.948|
72580498|NCT01870778|144690563|SUPERIORITY||Ratio of RLX030 to placebo|0.8597||||0.0007|TWO_SIDED|95.0|0.7876|0.9385|||Repeated measures model|||Day 2||0.9385|0.7876|0.0007
72580499|NCT01870778|144690563|SUPERIORITY||Ratio of RLX030 to placebo|0.9539||||0.3709|TWO_SIDED|95.0|0.86|1.0579|||Repeated measures model|||Day 5||1.0579|0.8600|0.3709
72580500|NCT01870778|144690563|SUPERIORITY||Ratio of RLX030 to placebo|0.9543||||0.3893|TWO_SIDED|95.0|0.8578|1.0617|||Repeated measures model|||Day 14||1.0617|0.8578|0.3893
72580501|NCT01870778|144690564|SUPERIORITY||Ratio of RLX030 to placebo|0.9637||||0.0003|TWO_SIDED|95.0|0.9447|0.983|||Repeated measures model|||Day 2||0.9830|0.9447|0.0003
72546435|NCT00601484|144622286|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-20.66|STANDARD_ERROR_OF_MEAN|8.138|||TWO_SIDED|90.0|-34.347|-6.971||||||Week 6: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||-6.971|-34.347|
72546436|NCT00601484|144622286|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-13.58|STANDARD_ERROR_OF_MEAN|9.532|||TWO_SIDED|90.0|-29.612|2.452||||||Week 10: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||2.452|-29.612|
72546437|NCT00601484|144622286|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-7.75|STANDARD_ERROR_OF_MEAN|8.807|||TWO_SIDED|90.0|-22.58|7.08||||||Week 16: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||7.080|-22.580|
72546438|NCT00601484|144622287|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.56|STANDARD_ERROR_OF_MEAN|0.721|||TWO_SIDED|90.0|-1.768|0.65||||||Week 2: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||0.650|-1.768|
72546439|NCT00601484|144622287|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.21|STANDARD_ERROR_OF_MEAN|0.898|||TWO_SIDED|90.0|-2.723|0.297||||||Week 4: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||0.297|-2.723|
72546440|NCT00601484|144622287|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.47|STANDARD_ERROR_OF_MEAN|1.311|||TWO_SIDED|90.0|-3.682|0.752||||||Week 6: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||0.752|-3.682|
72546441|NCT00601484|144622287|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.54|STANDARD_ERROR_OF_MEAN|0.98|||TWO_SIDED|90.0|-1.11|2.198||||||Week 10: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||2.198|-1.110|
72546442|NCT00601484|144622287|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.99|STANDARD_ERROR_OF_MEAN|1.114|||TWO_SIDED|90.0|-2.904|0.922||||||Week 16: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||0.922|-2.904|
72580502|NCT01870778|144690564|SUPERIORITY||Ratio of RLX030 to placebo|0.9922||||0.5361|TWO_SIDED|95.0|0.9677|1.0172|||Repeated measures model|||Day 5||1.0172|0.9677|0.5361
72580503|NCT01870778|144690564|SUPERIORITY||Ratio of RLX030 to placebo|0.9863||||0.375|TWO_SIDED|95.0|0.9567|1.0169|||Repeated measures model|||Day 14||1.0169|0.9567|0.3750
72580504|NCT00262028|144690568|NON_INFERIORITY_OR_EQUIVALENCE|MenACWY-CRM was considered to be noninferior to the licensed comparator if the lower limit (LL) of the 95% confidence intervals (CI) of the difference (MenACWY minus licensed comparator)in the percentage of the subjects with hSBA titer ≥ 1:4 at one month post vaccination was \> -10% against each serogroup|Vaccine group difference|37.0|||||TWO_SIDED|95.0|29.0|44.0||||||Noninferiority of immune responses of MenACWY-CRM to licensed comparator against serogroup A||44|29|
72412027|NCT01404312|144332149|SUPERIORITY||Hazard Ratio (HR)|1.396||||0.2802|TWO_SIDED|95.0|0.762|2.559||Not adjusted for multiple comparisons|Hazard Ratio||Hazard ratio given as: Arm B hazard / Arm A hazard, i.e. HR \> 1 favors arm A|"Competing risk analysis using the Fine-Gray model, treating TB-related deaths as competing risks, and other deaths including deaths of unknown cause as the event of interest.~H0: Hazard Ratio for Arm A vs Arm B = 1"||2.559|0.762|0.2802
72546443|NCT00601484|144622288|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-4.41|STANDARD_ERROR_OF_MEAN|5.51|||TWO_SIDED|90.0|-13.65|4.826||||||Week 2: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||4.826|-13.650|
72546444|NCT00601484|144622288|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-8.65|STANDARD_ERROR_OF_MEAN|7.041|||TWO_SIDED|90.0|-20.493|3.192||||||Week 4: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||3.192|-20.493|
72580505|NCT00262028|144690568|NON_INFERIORITY_OR_EQUIVALENCE|MenACWY-CRM was considered to be noninferior to the licensed comparator if the lower LL of the 95% CI of the difference (MenACWY minus licensed comparator)in the percentage of the subjects with hSBA titer ≥ 1:4 at one month post vaccination was \> -10% against each serogroup|Vaccine group difference|19.0|||||TWO_SIDED|95.0|12.0|26.0||||||Noninferiority of immune responses of MenACWY-CRM to licensed comparator against serogroup C||26|12|
72580506|NCT00262028|144690568|NON_INFERIORITY_OR_EQUIVALENCE|MenACWY-CRM was considered to be noninferior to the licensed comparator if the LL of the 95% CI of the difference (MenACWY minus licensed comparator)in the percentage of the subjects with hSBA titer ≥ 1:4 at one month post vaccination was \> -10% against each serogroup|Vaccine group difference|23.0|||||TWO_SIDED|95.0|17.0|29.0||||||Noninferiority of immune responses of MenACWY-CRM to licensed comparator against serogroup W||29|17|
72580507|NCT00262028|144690568|NON_INFERIORITY_OR_EQUIVALENCE|MenACWY-CRM was considered to be noninferior to the licensed comparator if the LL of the 95% CI of the difference (MenACWY minus licensed comparator)in the percentage of the subjects with hSBA titer ≥ 1:4 at one month post vaccination was \> -10% against each serogroup|Vaccine group difference|31.0|||||TWO_SIDED|95.0|25.0|38.0||||||No inferiority of immune responses of MenACWY-CRM to licensed comparator against serogroup Y||38|25|
72580508|NCT00262028|144690568|SUPERIORITY_OR_OTHER||Vaccine group difference|37.0|||||TWO_SIDED|95.0|29.0|44.0||||||"Superiority of immune responses of MenACWY-CRM to licensed comparator against serogroup A~MenACWY-CRM was considered to be superior to the licensed comparator if the LL of the 95% CI of the difference (MenACWY minus licensed comparator) in the percentage of the subjects with hSBA titer ≥ 1:4 at one month post vaccination was \> 0% against each serogroup"||44|29|
72580509|NCT00262028|144690568|SUPERIORITY_OR_OTHER||Vaccine group difference|19.0|||||TWO_SIDED|95.0|12.0|26.0||||||"Superiority of immune responses of MenACWY-CRM to licensed comparator against serogroup C~MenACWY-CRM was considered to be superior to the licensed comparator if the LL of the 95% CI of the difference (MenACWY minus licensed comparator) in the percentage of the subjects with hSBA titer ≥ 1:4 at one month post vaccination was \> 0% against each serogroup"||26|12|
72580510|NCT00262028|144690568|SUPERIORITY_OR_OTHER||Vaccine group difference|23.0|||||TWO_SIDED|95.0|17.0|29.0||||||"Superiority of immune responses of MenACWY-CRM to licensed comparator against serogroup W~MenACWY-CRM was considered to be superior to the licensed comparator if the LL of the 95% CI of the difference (MenACWY minus licensed comparator) in the percentage of the subjects with hSBA titer ≥ 1:4 at one month post vaccination was \> 0% against each serogroup"||29|17|
72580511|NCT00262028|144690568|SUPERIORITY_OR_OTHER||Vaccine group difference|31.0|||||TWO_SIDED|95.0|25.0|38.0||||||"Superiority of immune responses of MenACWY-CRM to licensed comparator against serogroup Y~MenACWY-CRM was considered to be superior to the licensed comparator if the LL of the 95% CI of the difference (MenACWY minus licensed comparator) in the percentage of the subjects with hSBA titer ≥ 1:4 at one month post vaccination was \> 0% against each serogroup"||38|25|
72580512|NCT00681031|144690617|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Acceptability was demonstrated if the lower bound of the two-sided 95% confidence interval (CI) on the Geometric Mean Fold Rise (CMFR) from pre-vaccination to 4 weeks postvaccination is \>1.4.|GMFR|3.1|||||TWO_SIDED|95.0|2.6|3.8|||||GMFR = GMT postdose divided by GMT predose|||3.8|2.6|
72580513|NCT03180645|144690622|OTHER||Least square (LS) mean difference|-1.07||||0.0638|TWO_SIDED|95.0|-2.21|0.06|||ANCOVA|Analysis model (ANCOVA) included participant as random effect, treatment arm and side of the face as fixed effects and baseline value as covariate.|Difference is the first named treatment adjusted (LS) mean change from baseline minus the second named treatment adjusted mean change from baseline.|||0.06|-2.21|0.0638
72580514|NCT01808573|144690634|SUPERIORITY||Hazard Ratio (HR)|0.762||||0.0059|TWO_SIDED|95.0|0.626|0.926|||Log Rank|Stratified by hormone receptor status, number of prior HER2-directed regimens in the metastatic setting, and visceral disease vs. non-visceral.|Lapatinib Plus Capecitabine is the reference. Stratified by hormone receptor status, number of prior HER2-directed regimens in the metastatic setting, and visceral disease vs. non-visceral.|||0.926|0.626|0.0059
72580515|NCT01808573|144690635|SUPERIORITY||Hazard Ratio (HR)|0.881||||0.2086|TWO_SIDED|95.0|0.723|1.073|||Log Rank|Stratified by hormone receptor status, number of prior HER2-directed regimens in the metastatic setting, and visceral disease vs. non-visceral.|Lapatinib plus Capecitabine is the reference. Stratified by hormone receptor status, number of prior HER2-directed regimens in the metastatic setting, and visceral disease vs. non-visceral.|||1.073|0.723|0.2086
72580516|NCT01808573|144690636|SUPERIORITY|||||||0.043|||||||Gray's test|Stratified by hormone receptor status, number of prior HER2-directed regimens in the metastatic setting and visceral disease vs. non-visceral disease.||||||0.043
72580517|NCT01808573|144690637|SUPERIORITY|||||||0.1201|||||||Cochran-Mantel-Haenszel|Stratified by hormone receptor status, number of prior HER2-directed regimens in the metastatic setting and visceral disease vs. non-visceral.||||||0.1201
72580518|NCT01808573|144690638|SUPERIORITY|||||||0.0328|||||||Cochran-Mantel-Haenszel|Stratified by hormone receptor status, number of prior HER2-directed regimens in the metastatic setting and visceral disease vs. non-visceral.||||||0.0328
72580519|NCT01808573|144690639|SUPERIORITY||Hazard Ratio (HR)|0.495||||0.0004|TWO_SIDED|95.0|0.332|0.736|||Log Rank||Lapatinib Plus Capecitabine is the reference.|||0.736|0.332|0.0004
72580520|NCT00141778|144690683|SUPERIORITY_OR_OTHER|||||||0.95||95.0|||||Chi-squared|||Discrete variables were compared among treatment groups with a chi-square test.||||0.95
72580521|NCT00141778|144690684|SUPERIORITY_OR_OTHER|||||||0.006||95.0|||||Chi-squared|||||||0.006
72580522|NCT00141778|144690685|SUPERIORITY_OR_OTHER|||||||0.15||95.0|||||Chi-squared|||||||0.15
72580523|NCT00141778|144690686|SUPERIORITY_OR_OTHER|||||||0.14||95.0|||||Chi-squared|||||||0.14
72580524|NCT00141778|144690687|SUPERIORITY_OR_OTHER|||||||0.56||95.0|||||Kruskal-Wallis|||||||0.56
72580525|NCT00141778|144690688|SUPERIORITY_OR_OTHER|||||||0.15||95.0|||||Kruskal-Wallis|||||||0.15
72580526|NCT00141778|144690689|SUPERIORITY_OR_OTHER|||||||0.38||95.0|||||Chi-squared|||||||0.38
72580527|NCT00141778|144690690|SUPERIORITY_OR_OTHER|||||||0.65||95.0|||||Chi-squared|||||||0.65
72580528|NCT02729909|144690694|SUPERIORITY||Median Value of confidence interval (CI)|1.0||||0.02|TWO_SIDED|95.0|0.1|1.9||Spontaneous bowel movement was analyzed using Van Elteren Test stratified by center. Centers with less participants were pooled based on geographical proximity.|Van Elteren Test|||||1.9|0.1|0.020
72580529|NCT02729909|144690695|SUPERIORITY||Median Value of CI|1.0||||0.051|TWO_SIDED|95.0|0.0|1.9||Spontaneous bowel movement was analyzed using Van Elteren Test stratified by center. Centers with less participants were pooled based on geographical proximity.|Van Elteren Test|||Week 2||1.9|0.0|0.051
72580530|NCT02729909|144690695|SUPERIORITY||Median Value of CI|1.5||||0.003|TWO_SIDED|95.0|1.0|2.0||Spontaneous bowel movement was analyzed using Van Elteren Test stratified by center. Centers with less participants were pooled based on geographical proximity.|Van Elteren Test|||Week 3||2.0|1.0|0.003
72580531|NCT02729909|144690695|SUPERIORITY||Median Value of CI|1.0||||0.009|TWO_SIDED|95.0|0.1|1.9||Spontaneous bowel movement was analyzed using Van Elteren Test stratified by center. Centers with less participants were pooled based on geographical proximity.|Van Elteren Test|||Week 4||1.9|0.1|0.009
72580532|NCT02729909|144690696|SUPERIORITY||Odds Ratio (OR)|2.08||||0.009|TWO_SIDED|95.0|1.19|3.62||The proportion of participants with an SBM within 24 hours after first dose in Week 1 is analyzed by a Cochran-Mantel-Haenszel (CMH) test stratified by center. Centers with less participants were pooled based on geographical proximity.|Cochran-Mantel-Haenszel|||||3.62|1.19|0.009
72580533|NCT02729909|144690697|SUPERIORITY||Median Value of CI|-0.4||||0.001|TWO_SIDED|95.0|-0.6|-0.2||Average Degree of Straining was analyzed using Van Elteren Test stratified by center. Centers with less participants were pooled based on geographical proximity.|Van Elteren Test|||Week 1||-0.2|-0.6|0.001
72580534|NCT02729909|144690697|SUPERIORITY||Median Value of CI|-0.3||||0.004|TWO_SIDED|95.0|-0.5|-0.1||Average Degree of Straining was analyzed using Van Elteren Test stratified by center. Centers with less participants were pooled based on geographical proximity.|Van Elteren Test|||Week 2||-0.1|-0.5|0.004
72580535|NCT02729909|144690697|SUPERIORITY||Median Value of CI|-0.2||||0.024|TWO_SIDED|95.0|-0.4|-0.1||Average Degree of Straining was analyzed using Van Elteren Test stratified by center. Centers with less participants were pooled based on geographical proximity.|Van Elteren Test|||Week 3||-0.1|-0.4|0.024
72580536|NCT02729909|144690697|SUPERIORITY||Median Value of CI|-0.3||||0.01|TWO_SIDED|95.0|-0.5|-0.1||Average Degree of Straining was analyzed using Van Elteren Test stratified by center. Centers with less participants were pooled based on geographical proximity.|Van Elteren Test|||Week 4||-0.1|-0.5|0.010
72580537|NCT02729909|144690698|SUPERIORITY||Median Value of CI|0.6|||<|0.001|TWO_SIDED|95.0|0.4|1.0||Mean Degree of Stool Consistency was analyzed using Van Elteren Test stratified by center. Centers with less participants were pooled based on geographical proximity.|Van Elteren Test|||Week 1||1.0|0.4|<0.001
72580538|NCT02729909|144690698|SUPERIORITY||Median Value of CI|0.6|||<|0.001|TWO_SIDED|95.0|0.4|0.9||Mean Degree of Stool Consistency was analyzed using Van Elteren Test stratified by center. Centers with less participants were pooled based on geographical proximity.|Van Elteren Test|||Week 2||0.9|0.4|<0.001
72580539|NCT02729909|144690698|SUPERIORITY||Median Value of CI|0.6|||<|0.001|TWO_SIDED|95.0|0.4|0.8||Mean Degree of Stool Consistency was analyzed using Van Elteren Test stratified by center. Centers with less participants were pooled based on geographical proximity.|Van Elteren Test|||Week 3||0.8|0.4|<0.001
72580540|NCT02729909|144690698|SUPERIORITY||Median Value of CI|0.5|||<|0.001|TWO_SIDED|95.0|0.2|0.7||Mean Degree of Stool Consistency was analyzed using Van Elteren Test stratified by center. Centers with less participants were pooled based on geographical proximity.|Van Elteren Test|||Week 4||0.7|0.2|<0.001
72546445|NCT00601484|144622288|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-9.72|STANDARD_ERROR_OF_MEAN|10.089|||TWO_SIDED|90.0|-26.775|7.343||||||Week 6: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||7.343|-26.775|
72546446|NCT00601484|144622288|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|3.76|STANDARD_ERROR_OF_MEAN|7.532|||TWO_SIDED|90.0|-8.95|16.465||||||Week 10: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||16.465|-8.950|
72546447|NCT00601484|144622288|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-8.72|STANDARD_ERROR_OF_MEAN|7.906|||TWO_SIDED|90.0|-22.299|4.851||||||Week 16: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||4.851|-22.299|
72546448|NCT00601484|144622289|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.24|STANDARD_ERROR_OF_MEAN|0.609|||TWO_SIDED|90.0|-0.776|1.265||||||Week 2: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||1.265|-0.776|
72580541|NCT02729909|144690699|SUPERIORITY||Median Value of CI|-0.5||||0.02|TWO_SIDED|95.0|-0.9|-0.1||Abdominal Bloating was analyzed using Van Elteren Test stratified by center. Centers with less participants were pooled based on geographical proximity.|Van Elteren Test|||Week 1||-0.1|-0.9|0.020
72580542|NCT02729909|144690699|SUPERIORITY|||||||0.072||||||Abdominal Bloating was analyzed using Van Elteren Test stratified by center. Centers with less participants were pooled based on geographical proximity.|Van Elteren Test|||Week 2||||0.072
72580543|NCT02729909|144690699|SUPERIORITY||Median Value of CI|-0.5|||<|0.001|TWO_SIDED|95.0|-0.9|-0.1||Abdominal Bloating was analyzed using Van Elteren Test stratified by center. Centers with less participants were pooled based on geographical proximity.|Van Elteren Test|||Week 3||-0.1|-0.9|<0.001
72580544|NCT02729909|144690699|SUPERIORITY||Median Value of CI|-0.5||||0.004|TWO_SIDED|95.0|-0.9|-0.1||Abdominal Bloating was analyzed using Van Elteren Test stratified by center. Centers with less participants were pooled based on geographical proximity.|Van Elteren Test|||Week 4||-0.1|-0.9|0.004
72580545|NCT02730663|144690708|NON_INFERIORITY|The number and percentage of patients who achieved clinical success at the time of stent removal are presented. A one-sided 97.5% confidence interval is to be calculated to confirm the degree of non-inferiority for the reference value (96%) and the difference (Investigational device - reference value) and if the lower limit of the confidence interval is -10% or higher, the noninferiority will be considered to be confirmed.|Reference value|-0.07||||0.05|ONE_SIDED|97.5||||A two-tail test was performed for statistics at a significance level of 0.05 unless otherwise specified.|t-test, 2 sided|||The clinical success rate at the time point of stent removal is reported 86.2% according to the approval data of the commercially available AXIOS stent submitted to the US FDA. The clinical success rates of EUS-guided transluminal drainage using a lumen-appending stent were 93.3% (29 cases), 100% (8 cases) and 100% (7 cases) respectively in the studies performed afterwards by Shah RJ (2015), Gornals JB (2012) and Moon JH (2014). The weighted average calculated for each study was about 96%.||||0.05
72580546|NCT01610492|144690728|OTHER||Geometric Mean|0.76|||||TWO_SIDED|95.0|0.57|1.01||||||||1.01|0.57|
72580547|NCT01610492|144690729|OTHER||Geometric Mean|0.27|||||TWO_SIDED|95.0|0.12|0.58||||||||0.58|0.12|
72580548|NCT04211831|144690826|OTHER||Least square mean difference|-1.29|||=|0.1722|TWO_SIDED|95.0|-3.16|0.58|||mixed model for repeated measures||Treatment comparison between Placebo and URO-902 24 mg using least sqaure mean difference and 95% confidence interval (CI) has been presented.|||0.58|-3.16|=0.1722
72580549|NCT04211831|144690826|OTHER||Least Square Mean Difference|-2.24|||=|0.0159|TWO_SIDED|95.0|-4.04|-0.43|||Mixed model for repeated measures||Treatment comparison between Placebo and URO-902 48 mg using least sqaure mean difference and 95% CI has been presented.|||-0.43|-4.04|=0.0159
72580550|NCT01256879|144690898|OTHER|Each CimTest-A, CimTest-B, and Commercial Cimetidine Solution are compared to Active Comparator (i.e. Sorbitol-free Cimetidine Solution), as a percentage of Active Comparator, per routine FDA bioequivalence testing of AUC.|||||||||||||||||Bioequivalence testing of AUC, per FDA guidance, is applied. Each CimTest-A, CimTest-B, and Commercial Cimetidine Solution are compared to Active Comparator (i.e. Sorbitol-free Cimetidine Solution), as a percentage of Active Comparator, per routine FDA bioequivalence testing of AUC. The upper and lower 90% Confidence Interval for CimTest-A is 104.4% to 120.6%. The upper and lower 90% Confidence Interval for CimTest-B is 97.9% to 113.0%. The upper and lower 90% Confidence Interval for Commercial Cimetidine Solution is 93.2% to 107.7%.|||
72546449|NCT00601484|144622289|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.09|STANDARD_ERROR_OF_MEAN|0.674|||TWO_SIDED|90.0|-1.22|1.044||||||Week 4: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||1.044|-1.220|
72546450|NCT00601484|144622289|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.57|STANDARD_ERROR_OF_MEAN|1.009|||TWO_SIDED|90.0|-1.124|2.269||||||Week 6: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||2.269|-1.124|
72546451|NCT00601484|144622289|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.27|STANDARD_ERROR_OF_MEAN|1.019|||TWO_SIDED|90.0|-1.441|1.988||||||Week 10: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||1.988|-1.441|
72546452|NCT00601484|144622289|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.99|STANDARD_ERROR_OF_MEAN|0.769|||TWO_SIDED|90.0|-0.307|2.283||||||Week 16: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||2.283|-0.307|
72546453|NCT00601484|144622290|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehman median difference|-1.68|||||TWO_SIDED|90.0|-9.05|5.76||||||Week 2: Van elteren test was used to compare the percent change from baseline between tanezumab and placebo using baseline average daily pain score (moderate \[4 to less than 7\] or severe \[greater than or equal to 7\]) as stratification variable.||5.76|-9.05|
72580551|NCT04927845|144690899|SUPERIORITY||between-group effect size Cohen's d|0.24||||0.008|TWO_SIDED|95.0|0.06|0.41|||linear mixed effects, groupXtime term|||||0.41|0.06|.008
72546454|NCT00601484|144622290|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehman median difference|-2.78|||||TWO_SIDED|90.0|-12.65|4.24||||||Week 4: Van elteren test was used to compare the percent change from baseline between tanezumab and placebo using baseline average daily pain score (moderate \[4 to less than 7\] or severe \[greater than or equal to 7\]) as stratification variable.||4.24|-12.65|
72546455|NCT00601484|144622290|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehman median difference|0.04|||||TWO_SIDED|90.0|-8.96|7.9||||||Week 6: Van elteren test was used to compare the percent change from baseline between tanezumab and placebo using baseline average daily pain score (moderate \[4 to less than 7\] or severe \[greater than or equal to 7\]) as stratification variable.||7.90|-8.96|
72546456|NCT00601484|144622290|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehman median difference|-1.38|||||TWO_SIDED|90.0|-11.57|8.28||||||Week 10: Van elteren test was used to compare the percent change from baseline between tanezumab and placebo using baseline average daily pain score (moderate \[4 to less than 7\] or severe \[greater than or equal to 7\]) as stratification variable.||8.28|-11.57|
72546457|NCT00601484|144622290|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehman median difference|3.97|||||TWO_SIDED|90.0|-6.82|13.02||||||Week 16: Van elteren test was used to compare the percent change from baseline between tanezumab and placebo using baseline average daily pain score (moderate \[4 to less than 7\] or severe \[greater than or equal to 7\]) as stratification variable.||13.02|-6.82|
72546458|NCT00601484|144622291|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.72|STANDARD_ERROR_OF_MEAN|1.01|||TWO_SIDED|90.0|-2.414|0.983||||||Week 2: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||0.983|-2.414|
72546459|NCT00601484|144622291|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.42|STANDARD_ERROR_OF_MEAN|1.169|||TWO_SIDED|90.0|-1.548|2.384||||||Week 4: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||2.384|-1.548|
72546460|NCT00601484|144622291|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.31|STANDARD_ERROR_OF_MEAN|0.821|||TWO_SIDED|90.0|-0.075|2.693||||||Week 6: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||2.693|-0.075|
72546461|NCT00601484|144622291|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.33|STANDARD_ERROR_OF_MEAN|1.093|||TWO_SIDED|90.0|-2.178|1.512||||||Week 10: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||1.512|-2.178|
72546462|NCT00601484|144622291|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.07|STANDARD_ERROR_OF_MEAN|1.208|||TWO_SIDED|90.0|0.038|4.112||||||Week 16: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||4.112|0.038|
72546463|NCT00601484|144622292|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehman median difference|-6.41|||||TWO_SIDED|90.0|-33.33|18.68||||||Week 2: Van elteren test was used to compare the percent change from baseline between tanezumab and placebo using baseline average daily pain score (moderate \[4 to less than 7\] or severe \[greater than or equal to 7\]) as stratification variable.||18.68|-33.33|
72546464|NCT00601484|144622292|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehman median difference|15.83|||||TWO_SIDED|90.0|-14.12|41.18||||||Week 4: Van elteren test was used to compare the percent change from baseline between tanezumab and placebo using baseline average daily pain score (moderate \[4 to less than 7\] or severe \[greater than or equal to 7\]) as stratification variable.||41.18|-14.12|
72546465|NCT00601484|144622292|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehman median difference|19.17|||||TWO_SIDED|90.0|0.0|38.1||||||Week 6: Van elteren test was used to compare the percent change from baseline between tanezumab and placebo using baseline average daily pain score (moderate \[4 to less than 7\] or severe \[greater than or equal to 7\]) as stratification variable.||38.10|0.00|
72580552|NCT04927845|144690899|SUPERIORITY||Slope|1.75||||0.03|TWO_SIDED||||||linear mixed effects, groupXtime term|||Per Protocol Analyses of Intervention Effects: comparing the waitlist condition versus only intervention group participants who were program initiators||||.03
72580553|NCT04927845|144690899|SUPERIORITY|||||||0.009|||||||linear mixed effects, groupXtime term|||Per Protocol Analyses of Intervention Effects: concurrent service use was added as a covariate to models.||||.009
72580554|NCT04927845|144690900|SUPERIORITY||between-group effect size Cohen's d|0.11||||0.21|TWO_SIDED||||||linear mixed effects, groupXtime term|||||||.21
72580555|NCT04927845|144690901|SUPERIORITY||between-group effect size Cohen's d|0.19||||0.046|TWO_SIDED|95.0|0.02|0.36|||linear mixed effects, groupXtime term|||||0.36|0.02|.046
72546466|NCT00601484|144622292|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehman median difference|-0.71|||||TWO_SIDED|90.0|-30.95|32.73||||||Week 10: Van elteren test was used to compare the percent change from baseline between tanezumab and placebo using baseline average daily pain score (moderate \[4 to less than 7\] or severe \[greater than or equal to 7\]) as stratification variable.||32.73|-30.95|
72580556|NCT05201794|144690914|SUPERIORITY||Odds Ratio (OR)|67.3|||=|0.1409|ONE_SIDED|80.0|15.2|||One-sided p-value|Exact logistic regression model|P-value was obtained from an exact logistic regression model adjusted for stratification factor region (America, Asia).|1-sided odds-ratio and 80% CI were obtained from exact logistic regression model adjusted for region (America, Asia).|The study was prematurely terminated before reaching the number of laboratory-confirmed DENV infections that were planned for the interim analysis. The 1-sided 20% significance level was described in the protocol as the significance level for proof-of-concept (PoC) when the planned interim analysis would have been performed.|||15.2|=0.1409
72546467|NCT00601484|144622292|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehman median difference|34.89|||||TWO_SIDED|90.0|-4.57|70.0||||||Week 16: Van elteren test was used to compare the percent change from baseline between tanezumab and placebo using baseline average daily pain score (moderate \[4 to less than 7\] or severe \[greater than or equal to 7\]) as stratification variable.||70.00|-4.57|
72546468|NCT00601484|144622293|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.04|STANDARD_ERROR_OF_MEAN|0.34|||TWO_SIDED|90.0|-0.529|0.61||||||Week 2: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||0.610|-0.529|
72546469|NCT00601484|144622293|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.52|STANDARD_ERROR_OF_MEAN|0.334|||TWO_SIDED|90.0|-1.077|0.043||||||Week 4: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||0.043|-1.077|
72546470|NCT00601484|144622293|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.22|STANDARD_ERROR_OF_MEAN|0.366|||TWO_SIDED|90.0|-0.835|0.396||||||Week 6: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||0.396|-0.835|
72546471|NCT00601484|144622293|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.22|STANDARD_ERROR_OF_MEAN|0.294|||TWO_SIDED|90.0|-0.718|0.273||||||Week 10: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||0.273|-0.718|
72546472|NCT00601484|144622293|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.442|||TWO_SIDED|90.0|-1.044|0.445||||||Week 16: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||0.445|-1.044|
72546473|NCT00601484|144622294|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehman median difference|-1.24|||||TWO_SIDED|90.0|-27.56|5.37||||||Week 2: Van elteren test was used to compare the percent change from baseline between tanezumab and placebo using baseline average daily pain score (moderate \[4 to less than 7\] or severe \[greater than or equal to 7\]) as stratification variable.||5.37|-27.56|
72546474|NCT00601484|144622294|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehman median difference|-22.43|||||TWO_SIDED|90.0|-56.39|0.0||||||Week 4: Van elteren test was used to compare the percent change from baseline between tanezumab and placebo using baseline average daily pain score (moderate \[4 to less than 7\] or severe \[greater than or equal to 7\]) as stratification variable.||0.00|-56.39|
72546475|NCT00601484|144622294|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehman median difference|-16.0|||||TWO_SIDED|90.0|-40.44|0.0||||||Week 6: Van elteren test was used to compare the percent change from baseline between tanezumab and placebo using baseline average daily pain score (moderate \[4 to less than 7\] or severe \[greater than or equal to 7\]) as stratification variable.||0.00|-40.44|
72546476|NCT00601484|144622294|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehman median difference|-14.18|||||TWO_SIDED|90.0|-50.71|0.0||||||Week 10: Van elteren test was used to compare the percent change from baseline between tanezumab and placebo using baseline average daily pain score (moderate \[4 to less than 7\] or severe \[greater than or equal to 7\]) as stratification variable.||0.00|-50.71|
72546477|NCT00601484|144622294|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehman median difference|-8.61|||||TWO_SIDED|90.0|-36.87|4.64||||||Week 16: Van elteren test was used to compare the percent change from baseline between tanezumab and placebo using baseline average daily pain score (moderate \[4 to less than 7\] or severe \[greater than or equal to 7\]) as stratification variable.||4.64|-36.87|
72546478|NCT00601484|144622295|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|5.1|STANDARD_ERROR_OF_MEAN|12.495|||TWO_SIDED|90.0|-15.852|26.044||||||Week 2: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||26.044|-15.852|
72546479|NCT00601484|144622295|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|4.27|STANDARD_ERROR_OF_MEAN|12.802|||TWO_SIDED|90.0|-17.216|25.764||||||Week 4: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||25.764|-17.216|
72546480|NCT00601484|144622295|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-2.81|STANDARD_ERROR_OF_MEAN|13.741|||TWO_SIDED|90.0|-25.917|20.307||||||Week 6: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||20.307|-25.917|
72546481|NCT00601484|144622295|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.73|STANDARD_ERROR_OF_MEAN|12.416|||TWO_SIDED|90.0|-21.626|20.162||||||Week 10: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||20.162|-21.626|
72546482|NCT00601484|144622295|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|10.51|STANDARD_ERROR_OF_MEAN|14.469|||TWO_SIDED|90.0|-13.858|34.868||||||Week 16: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||34.868|-13.858|
72546483|NCT00601484|144622296|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|3.63|STANDARD_ERROR_OF_MEAN|6.968|||TWO_SIDED|90.0|-8.049|15.316||||||Week 2: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||15.316|-8.049|
72546484|NCT00601484|144622296|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|3.19|STANDARD_ERROR_OF_MEAN|7.353|||TWO_SIDED|90.0|-9.153|15.533||||||Week 4: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||15.533|-9.153|
72546485|NCT00601484|144622296|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.94|STANDARD_ERROR_OF_MEAN|7.651|||TWO_SIDED|90.0|-13.806|11.932||||||Week 6: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||11.932|-13.806|
72546486|NCT00601484|144622296|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|6.79|STANDARD_ERROR_OF_MEAN|7.543|||TWO_SIDED|90.0|-5.901|19.486||||||Week 10: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||19.486|-5.901|
72546487|NCT00601484|144622296|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|4.77|STANDARD_ERROR_OF_MEAN|8.31|||TWO_SIDED|90.0|-9.221|18.765||||||Week 16: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||18.765|-9.221|
72546488|NCT00601484|144622297|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.86|STANDARD_ERROR_OF_MEAN|0.407|||TWO_SIDED|90.0|-1.546|-0.182||||||Week 2: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||-0.182|-1.546|
72580557|NCT05201794|144690914|SUPERIORITY||Odds Ratio (OR)|67.2|||=|0.1418|ONE_SIDED|80.0|14.9|||One-sided p-value|Exact logistic regression model|P-value was obtained from an exact logistic regression model adjusted for stratification factor region (America, Asia).|1-sided odds-ratio and 80% CI were obtained from exact logistic regression model adjusted for region (America, Asia).|The study was prematurely terminated before reaching the number of laboratory-confirmed DENV infections that were planned for the interim analysis. The 1-sided 20% significance level was described in the protocol as the significance level for PoC when the planned interim analysis would have been performed.|||14.9|=0.1418
72580558|NCT05201794|144690915|SUPERIORITY||Odds Ratio (OR)|87.8|||=|0.0192|ONE_SIDED|80.0|58.1|||One-sided p-value|Exact logistic regression model|P-value was obtained from an exact logistic regression model adjusted for stratification factor region (America, Asia).|1-sided odds-ratio and 80% CI were obtained from exact logistic regression model adjusted for region (America, Asia).|The study was prematurely terminated before reaching the number of laboratory-confirmed DENV infections that were planned for the interim analysis. The 1-sided 20% significance level was described in the protocol as the significance level for PoC when the planned interim analysis would have been performed.|||58.1|=0.0192
72580559|NCT05201794|144690915|SUPERIORITY||Odds Ratio (OR)|62.9|||=|0.1131|ONE_SIDED|80.0|20.0|||One-sided p-value|Exact logistic regression model|P-value was obtained from an exact logistic regression model adjusted for stratification factor region (America, Asia).|1-sided odds-ratio and 80% CI were obtained from exact logistic regression model adjusted for region (America, Asia).|The study was prematurely terminated before reaching the number of laboratory-confirmed DENV infections that were planned for the interim analysis. The 1-sided 20% significance level was described in the protocol as the significance level for PoC when the planned interim analysis would have been performed.|||20|=0.1131
72580560|NCT05201794|144690916|SUPERIORITY||Odds Ratio (OR)|85.4|||=|0.0302|ONE_SIDED|80.0|62.6|||One-sided p-value|Exact logistic regression model|P-value was obtained from an exact logistic regression model adjusted for stratification factor region (America, Asia).|1-sided odds-ratio and 80% CI were obtained from exact logistic regression model adjusted for region (America, Asia).|The study was prematurely terminated before reaching the number of laboratory-confirmed DENV infections that were planned for the interim analysis. The 1-sided 20% significance level was described in the protocol as the significance level for PoC when the planned interim analysis would have been performed.|||62.6|=0.0302
72546489|NCT00601484|144622297|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.38|STANDARD_ERROR_OF_MEAN|0.484|||TWO_SIDED|90.0|-2.196|-0.57||||||Week 4: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||-0.570|-2.196|
72546490|NCT00601484|144622297|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.3|STANDARD_ERROR_OF_MEAN|0.54|||TWO_SIDED|90.0|-2.204|-0.388||||||Week 6: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||-0.388|-2.204|
72546491|NCT00601484|144622297|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.1|STANDARD_ERROR_OF_MEAN|0.553|||TWO_SIDED|90.0|-2.032|-0.172||||||Week 10: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||-0.172|-2.032|
72546492|NCT00601484|144622297|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.02|STANDARD_ERROR_OF_MEAN|0.512|||TWO_SIDED|90.0|-1.878|-0.152||||||Week 16: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||-0.152|-1.878|
72546493|NCT00601484|144622298|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-16.24|STANDARD_ERROR_OF_MEAN|8.064|||TWO_SIDED|90.0|-29.757|-2.718||||||Week 2: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||-2.718|-29.757|
72546494|NCT00601484|144622298|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-27.96|STANDARD_ERROR_OF_MEAN|10.059|||TWO_SIDED|90.0|-44.846|-11.075||||||Week 4: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||-11.075|-44.846|
72546495|NCT00601484|144622298|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-25.72|STANDARD_ERROR_OF_MEAN|11.508|||TWO_SIDED|90.0|-45.079|-6.369||||||Week 6: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||-6.369|-45.079|
72546496|NCT00601484|144622298|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-19.56|STANDARD_ERROR_OF_MEAN|12.157|||TWO_SIDED|90.0|-40.017|0.902||||||Week 10: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||0.902|-40.017|
72546497|NCT00601484|144622298|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-21.9|STANDARD_ERROR_OF_MEAN|11.124|||TWO_SIDED|90.0|-40.633|-3.171||||||Week 16: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||-3.171|-40.633|
72546498|NCT00601484|144622299|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.5|STANDARD_ERROR_OF_MEAN|0.86|||TWO_SIDED|90.0|-2.942|-0.057||||||Week 2: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||-0.057|-2.942|
72546499|NCT00601484|144622299|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-2.08|STANDARD_ERROR_OF_MEAN|0.82|||TWO_SIDED|90.0|-3.458|-0.705||||||Week 4: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||-0.705|-3.458|
72546500|NCT00601484|144622299|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-2.13|STANDARD_ERROR_OF_MEAN|1.267|||TWO_SIDED|90.0|-4.265|-0.004||||||Week 6: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||-0.004|-4.265|
72546501|NCT00601484|144622299|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.45|STANDARD_ERROR_OF_MEAN|1.531|||TWO_SIDED|90.0|-4.029|1.124||||||Week 10: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||1.124|-4.029|
72580561|NCT05201794|144690916|SUPERIORITY||Odds Ratio (OR)|60.5|||=|0.2239|ONE_SIDED|80.0|-6.3|||One-sided p-value|Exact logistic regression model|P-value was obtained from an exact logistic regression model adjusted for stratification factor region (America, Asia).|1-sided odds-ratio and 80% CI were obtained from exact logistic regression model adjusted for region (America, Asia).|The study was prematurely terminated before reaching the number of laboratory-confirmed DENV infections that were planned for the interim analysis. The 1-sided 20% significance level was described in the protocol as the significance level for PoC when the planned interim analysis would have been performed.|||-6.3|=0.2239
72580562|NCT06418529|144690923|OTHER||Hazard Ratio (HR)|0.94|||||TWO_SIDED|95.0|0.85|1.05||||||||1.05|0.85|
72580563|NCT06418529|144690924|OTHER||Hazard Ratio (HR)|0.94|||||TWO_SIDED|95.0|0.83|1.07||||||||1.07|0.83|
72580564|NCT06418529|144690925|OTHER||Hazard Ratio (HR)|0.88|||||TWO_SIDED|95.0|0.79|0.99||||||||0.99|0.79|
72580565|NCT06418529|144690926|OTHER||Hazard Ratio (HR)|0.91|||||TWO_SIDED|95.0|0.79|1.04||||||||1.04|0.79|
72546502|NCT00601484|144622299|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-2.24|STANDARD_ERROR_OF_MEAN|1.293|||TWO_SIDED|90.0|-4.419|-0.063||||||Week 16: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||-0.063|-4.419|
72546503|NCT00601484|144622300|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehman median difference|-7.93|||||TWO_SIDED|90.0|-27.32|11.32||||||Week 2: Van elteren test was used to compare the percent change from baseline between tanezumab and placebo using baseline average daily pain score (moderate \[4 to less than 7\] or severe \[greater than or equal to 7\] as stratification variable.||11.32|-27.32|
72546504|NCT00601484|144622300|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehman median difference|-17.9|||||TWO_SIDED|90.0|-42.04|4.37||||||Week 4: Van elteren test was used to compare the percent change from baseline between tanezumab and placebo using baseline average daily pain score (moderate \[4 to less than 7\] or severe \[greater than or equal to 7\] as stratification variable.||4.37|-42.04|
72546505|NCT00601484|144622300|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehman median difference|-24.44|||||TWO_SIDED|90.0|-51.58|0.67||||||Week 6: Van elteren test was used to compare the percent change from baseline between tanezumab and placebo using baseline average daily pain score (moderate \[4 to less than 7\] or severe \[greater than or equal to 7\] as stratification variable.||0.67|-51.58|
72546506|NCT00601484|144622300|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehman median difference|-7.5|||||TWO_SIDED|90.0|-41.71|17.33||||||Week 10: Van elteren test was used to compare the percent change from baseline between tanezumab and placebo using baseline average daily pain score (moderate \[4 to less than 7\] or severe \[greater than or equal to 7\] as stratification variable.||17.33|-41.71|
72546507|NCT00601484|144622300|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehman median difference|-21.37|||||TWO_SIDED|90.0|-54.76|7.92||||||Week 16: Van elteren test was used to compare the percent change from baseline between tanezumab and placebo using baseline average daily pain score (moderate \[4 to less than 7\] or severe \[greater than or equal to 7\] as stratification variable.||7.92|-54.76|
72546508|NCT00601484|144622301|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.32|STANDARD_ERROR_OF_MEAN|0.165|||TWO_SIDED|90.0|-0.591|-0.04||||||Week 2: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||-0.040|-0.591|
72580566|NCT06418529|144690927|OTHER||Hazard Ratio (HR)|0.92|||||TWO_SIDED|95.0|0.81|1.05||||||||1.05|0.81|
72580567|NCT06418529|144690928|OTHER||Hazard Ratio (HR)|0.93|||||TWO_SIDED|95.0|0.79|1.09||||||||1.09|0.79|
72580568|NCT04653454|144690930|SUPERIORITY|||||||0.129||||||Hypoglycemic Episodes \<54 mg/dL|Wilcoxon (Mann-Whitney)|||||||0.129
72580569|NCT04653454|144690930|SUPERIORITY|||||||0.008||||||Hypoglycemic Episodes \<70 mg/dL|Wilcoxon (Mann-Whitney)|||||||0.008
72580570|NCT04653454|144690931|SUPERIORITY|||||||0.203||||||Hypoglycemic Episodes \<54 mg/dL|Wilcoxon (Mann-Whitney)|||||||0.203
72580571|NCT04653454|144690931|SUPERIORITY||||||<|0.001||||||Hypoglycemic Episodes \<70 mg/dL|Wilcoxon (Mann-Whitney)|||||||<0.001
72580572|NCT04653454|144690933|SUPERIORITY|||||||0.076||||||Hyperglycemic Episodes \>180 mg/dL|Wilcoxon (Mann-Whitney)|||||||0.076
72580573|NCT04653454|144690933|SUPERIORITY|||||||0.038||||||Hyperglycemic Episodes \>250 mg/dL|Wilcoxon (Mann-Whitney)|||||||0.038
72546509|NCT00601484|144622301|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.36|STANDARD_ERROR_OF_MEAN|0.225|||TWO_SIDED|90.0|-0.734|0.02||||||Week 4: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||0.020|-0.734|
72546510|NCT00601484|144622301|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.37|STANDARD_ERROR_OF_MEAN|0.211|||TWO_SIDED|90.0|-0.724|-0.015||||||Week 6: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||-0.015|-0.724|
72546511|NCT00601484|144622301|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.41|STANDARD_ERROR_OF_MEAN|0.238|||TWO_SIDED|90.0|-0.806|-0.005||||||Week 10: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||-0.005|-0.806|
72546512|NCT00601484|144622301|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.12|STANDARD_ERROR_OF_MEAN|0.206|||TWO_SIDED|90.0|-0.47|0.223||||||Week 16: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||0.223|-0.470|
72546513|NCT00601484|144622302|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-15.34|STANDARD_ERROR_OF_MEAN|8.425|||TWO_SIDED|90.0|-29.468|-1.209||||||Week 2: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||-1.209|-29.468|
72546514|NCT00601484|144622302|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-16.97|STANDARD_ERROR_OF_MEAN|11.102|||TWO_SIDED|90.0|-35.608|1.665||||||Week 4: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||1.665|-35.608|
72546515|NCT00601484|144622302|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-18.04|STANDARD_ERROR_OF_MEAN|10.358|||TWO_SIDED|90.0|-35.476|-0.613||||||Week 6: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||-0.613|-35.476|
72546516|NCT00601484|144622302|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-19.48|STANDARD_ERROR_OF_MEAN|13.631|||TWO_SIDED|90.0|-42.418|3.46||||||Week 10: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||3.460|-42.418|
72546517|NCT00601484|144622302|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-9.16|STANDARD_ERROR_OF_MEAN|10.097|||TWO_SIDED|90.0|-26.174|7.849||||||Week 16: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||7.849|-26.174|
72546518|NCT00601484|144622303|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.68|STANDARD_ERROR_OF_MEAN|0.404|||TWO_SIDED|90.0|-1.394|0.03||||||Week 2: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||0.030|-1.394|
72546519|NCT00601484|144622303|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.34|STANDARD_ERROR_OF_MEAN|0.454|||TWO_SIDED|90.0|-1.149|0.468||||||Week 4: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||0.468|-1.149|
72546520|NCT00601484|144622303|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.64|STANDARD_ERROR_OF_MEAN|0.449|||TWO_SIDED|90.0|-1.443|0.156||||||Week 6: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||0.156|-1.443|
72546521|NCT00601484|144622303|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.06|STANDARD_ERROR_OF_MEAN|0.546|||TWO_SIDED|90.0|-1.046|0.931||||||Week 10: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||0.931|-1.046|
72546522|NCT00601484|144622303|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.64|STANDARD_ERROR_OF_MEAN|0.673|||TWO_SIDED|90.0|-1.876|0.592||||||Week 16: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||0.592|-1.876|
72546523|NCT00601484|144622304|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-34.25|STANDARD_ERROR_OF_MEAN|21.509|||TWO_SIDED|90.0|-72.879|4.375||||||Week 2: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||4.375|-72.879|
72546524|NCT00601484|144622304|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-30.97|STANDARD_ERROR_OF_MEAN|24.418|||TWO_SIDED|90.0|-75.23|13.285||||||Week 4: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||13.285|-75.230|
72546525|NCT00601484|144622304|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-37.18|STANDARD_ERROR_OF_MEAN|28.74|||TWO_SIDED|90.0|-90.62|16.265||||||Week 6: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||16.265|-90.620|
72546526|NCT00601484|144622304|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|5.77|STANDARD_ERROR_OF_MEAN|43.222|||TWO_SIDED|90.0|-74.604|86.142||||||Week 10: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||86.142|-74.604|
72546527|NCT00601484|144622304|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-21.35|STANDARD_ERROR_OF_MEAN|70.862|||TWO_SIDED|90.0|-164.142|121.438||||||Week 16: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||121.438|-164.142|
72546528|NCT00601484|144622307|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.24|STANDARD_ERROR_OF_MEAN|0.788|||TWO_SIDED|90.0|-2.562|0.081||||||Week 2: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||0.081|-2.562|
72580574|NCT04653454|144690934|SUPERIORITY||||||<|0.0001||||||Creatinine|Spearman Correlation coefficients|||||||<0.0001
72580575|NCT04653454|144690934|SUPERIORITY|||||||0.0002||||||139GFR|Spearman Correlation coefficients|||||||0.0002
72546529|NCT00601484|144622307|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.12|STANDARD_ERROR_OF_MEAN|0.986|||TWO_SIDED|90.0|-2.782|0.535||||||Week 4: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||0.535|-2.782|
72546530|NCT00601484|144622307|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.11|STANDARD_ERROR_OF_MEAN|1.14|||TWO_SIDED|90.0|-3.036|0.819||||||Week 6: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||0.819|-3.036|
72546531|NCT00601484|144622307|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.16|STANDARD_ERROR_OF_MEAN|0.816|||TWO_SIDED|90.0|-1.534|1.221||||||Week 10: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||1.221|-1.534|
72546532|NCT00601484|144622307|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.54|STANDARD_ERROR_OF_MEAN|1.083|||TWO_SIDED|90.0|-2.398|1.32||||||Week 16: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||1.320|-2.398|
72580576|NCT04653454|144690934|SUPERIORITY|||||||0.22||||||Bicarbonate|Spearman Correlation coefficients|||||||0.22
72580577|NCT04653454|144690934|SUPERIORITY|||||||0.48||||||Hemoglobin|Spearman Correlation coefficients|||||||0.48
72580578|NCT04653454|144690934|SUPERIORITY|||||||0.77||||||MAP|Spearman Correlation coefficients|||||||0.77
72580579|NCT04653454|144690934|SUPERIORITY|||||||0.0516||||||SpO2|Spearman Correlation coefficients|||||||0.0516
72580580|NCT03620708|144690939|SUPERIORITY||chi-square|3.492|||<|0.05|TWO_SIDED||||||Chi-squared|||||||<0.05
72580581|NCT03620708|144690940|SUPERIORITY||chi-square|4.36||||0.113|TWO_SIDED||||||Chi-squared|||||||.113
72580582|NCT03620708|144690941|SUPERIORITY||Mean Difference (Final Values)|3.661||||0.032|TWO_SIDED||||||ANOVA|||||||.032
72580583|NCT03620708|144690942|SUPERIORITY||Mean Difference (Final Values)|1.543||||0.227|TWO_SIDED||||||ANOVA|||Examination of differences between groups at follow-up on a measure of confidence in ability to quit.||||.227
72580584|NCT03620708|144690942|SUPERIORITY||Mean Difference (Final Values)|0.338||||0.715|TWO_SIDED||||||ANOVA|||Examination of differences between groups at follow-up on a measure of self-reported importance of quitting smoking.||||.715
72580585|NCT03620708|144690942|SUPERIORITY||Mean Difference (Final Values)|1.712||||0.19|TWO_SIDED||||||ANOVA|||Examination of differences between groups at follow-up on a measure of self-reported readiness to quit smoking.||||.190
72580586|NCT03620708|144690943|SUPERIORITY||Mean Difference (Final Values)|1.728||||0.188|TWO_SIDED||||||ANOVA|||||||.188
72580587|NCT05525520|144690956|EQUIVALENCE|two-sided equivalence test|Least square mean difference (LSMD)|0.46|STANDARD_ERROR_OF_MEAN|0.609||0.4577|TWO_SIDED|95.0|-0.77|1.68|||MMRM|Treatment, type of cholestatic disease, week, and treatment-by-week interaction were fixed effects, and Baseline WI-NRS score was a covariate.|LSMD=EP547 minus placebo|||1.68|-0.77|0.4577
72580588|NCT03657797|144690974|NON_INFERIORITY|LS mean, the difference in LS mean (NCX 470 minus latanoprost), and the 2-sided 95% CI for the difference was obtained. Non-inferiority could be claimed if the upper limit of the 2-sided 95% CI around the difference between the LS mean for NCX 470 and the LS mean for latanoprost was \< 1.5 mmHg. If non-inferiority was met, superiority was tested which could be claimed if the p-value for treatment difference was \<= 0.05 and the LS mean difference in change from baseline was \< 0.|Mean Difference (Final Values)|-0.4||||0.2666|TWO_SIDED|95.0|-1.11|0.31||p-value was not adjusted for multiple comparisons|ANCOVA|||NCX 470 0.21% was compared to latanoprost.||0.31|-1.11|0.2666
72580589|NCT03657797|144690974|NON_INFERIORITY|LS mean, the difference in LS mean (NCX 470 minus latanoprost), and the 2-sided 95% CI for the difference was obtained. Non-inferiority could be claimed if the upper limit of the 2-sided 95% CI around the difference between the LS mean for NCX 470 and the LS mean for latanoprost was \< 1.5 mmHg. If non-inferiority was met, superiority was tested which could be claimed if the p-value for treatment difference was \<= 0.05 and the LS mean difference in change from baseline was \< 0.|Mean Difference (Final Values)|-0.81||||0.0281|TWO_SIDED|95.0|-1.52|-0.09||p-value was not adjusted for multiple comparisons|ANCOVA|||NCX 0.042% was compared to latanoprost.||-0.09|-1.52|0.0281
72580590|NCT03657797|144690974|NON_INFERIORITY|LS mean, the difference in LS mean (NCX 470 minus latanoprost), and the 2-sided 95% CI for the difference was obtained. Non-inferiority could be claimed if the upper limit of the 2-sided 95% CI around the difference between the LS mean for NCX 470 and the LS mean for latanoprost was \< 1.5 mmHg. If non-inferiority was met, superiority was tested which could be claimed if the p-value for treatment difference was \<= 0.05 and the LS mean difference in change from baseline was \< 0.|Mean Difference (Final Values)|-1.23||||0.0009|TWO_SIDED|95.0|-1.96|-0.51||p-value was not adjusted for multiple comparisons|ANCOVA|||NCX 0.065% was compared to latanoprost.||-0.51|-1.96|0.0009
72580591|NCT03657797|144690975|NON_INFERIORITY|NCX 470 0.021% was compared to latanoprost 0.005% at each visit. The LS mean, LS mean difference and the 95% CIs for the difference was calculated. Non-inferiority at each visit could be claimed if the upper limit of the 95% CI was \<1.5 mmHg. If non-inferiority was established, superiority could be claimed if the upper limit of the 95% CI was \<0 and p\<0.05.|||||<|0.9788||||||p-value was not adjusted for multiple comparisons|ANCOVA|Upper 95% CIs were 0.51 (week 1), 0.68 (week 2), 0.75 (exit visit); p-values were 0.5560 (week 1), 0.9788 (week 2), 0.8796 (exit visit)||NCX 470 0.021% was compared to latanoprost.||||<0.9788
72580592|NCT03657797|144690975|NON_INFERIORITY|NCX 470 0.042% was compared to latanoprost 0.005% at each visit. The LS mean, LS mean difference and the 95% CIs for the difference was calculated. Non-inferiority at each visit could be claimed if the upper limit of the 95% CI was \<1.5 mmHg. If non-inferiority was established, superiority could be claimed if the upper limit of the 95% CI was \<0 and p\<0.05.|||||<|0.3863||||||p-value was not adjusted for multiple comparisons|ANCOVA|Upper 95% CIs were 0.20 (week 1), 0.38 (week 2), 0.11 (exit visit); p-values were 0.1556 (week 1), 0.3863 (week 2), 0.0912 (exit visit)||NCX 470 0.042% was compared to latanoprost.||||<0.3863
72580593|NCT03657797|144690975|NON_INFERIORITY|NCX 470 0.065% was compared to latanoprost 0.005% at each visit. The LS mean, LS mean difference and the 95% CIs for the difference was calculated. Non-inferiority at each visit could be claimed if the upper limit of the 95% CI was \<1.5 mmHg. If non-inferiority was established, superiority could be claimed if the upper limit of the 95% CI was \<0 and p\<0.05.|||||<|0.0174||||||p-value was not adjusted for multiple comparisons|ANCOVA|Upper 95% CIs were -0.35 (week 1), -0.15 (week 2), -0.27 (exit visit); p-values were 0.0040 (week 1), 0.0174 (week 2), 0.0093 (exit visit)||NCX 470 0.065% was compared to latanoprost.||||<0.0174
72580594|NCT00276484|144690989|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-16.3|STANDARD_ERROR_OF_MEAN|1.6|<|0.001||95.0|-19.4|-13.2|||ANCOVA|Model terms: treatment and baseline LDL-C value||||-13.2|-19.4|<0.001
72580595|NCT00276484|144690990|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.5|STANDARD_ERROR_OF_MEAN|0.8||0.551||95.0|-1.1|2.1|||ANCOVA|Model terms: treatment and baseline HDL-C value||||2.1|-1.1|0.551
72546533|NCT00601484|144622308|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-10.99|STANDARD_ERROR_OF_MEAN|6.718|||TWO_SIDED|90.0|-22.25|0.277||||||Week 2: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||0.277|-22.250|
72580596|NCT00276484|144690991|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-14.3|STANDARD_ERROR_OF_MEAN|1.4|<|0.001||95.0|-17.1|-11.6|||ANCOVA|Model terms: treatment and baseline non-HDL-C value||||-11.6|-17.1|<0.001
72580597|NCT00276484|144690992|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-10.0|STANDARD_ERROR_OF_MEAN|1.0|<|0.001||95.0|-12.0|-7.9|||ANCOVA|Model terms: treatment and baseline Total-C value||||-7.9|-12.0|<0.001
72580598|NCT00276484|144690993|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-7.3|||<|0.001||95.0|-11.5|-3.1|||Nonparametric ANCOVA|ANCOVA using ranks based on normal scores (Tukey method) with model terms for treatment and baseline triglycerides value.|The median difference is based on the Hodges-Lehmann estimates of shift; The distribution-free 95% CI is based on Wilcoxon's rank sum test statistic.|||-3.1|-11.5|<0.001
72580599|NCT00276484|144690994|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-10.1|STANDARD_ERROR_OF_MEAN|1.3|<|0.001||95.0|-12.7|-7.6|||ANCOVA|Model terms: treatment and baseline Apo B value||||-7.6|-12.7|<0.001
72580600|NCT00276484|144690995|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.9|STANDARD_ERROR_OF_MEAN|0.8||0.313||95.0|-0.8|2.5|||ANCOVA|Model terms: treatment and baseline Apo A-I value||||2.5|-0.8|0.313
72580601|NCT00276484|144690996|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-10.4|STANDARD_ERROR_OF_MEAN|1.1|<|0.001||95.0|-12.6|-8.2|||ANCOVA|Model terms: treatment and baseline Total-C:HDL-C value||||-8.2|-12.6|<0.001
72546534|NCT00601484|144622308|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-8.43|STANDARD_ERROR_OF_MEAN|8.66|||TWO_SIDED|90.0|-23.001|6.132||||||Week 4: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||6.132|-23.001|
72546535|NCT00601484|144622308|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-8.14|STANDARD_ERROR_OF_MEAN|9.737|||TWO_SIDED|90.0|-24.602|8.327||||||Week 6: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||8.327|-24.602|
72546536|NCT00601484|144622308|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.45|STANDARD_ERROR_OF_MEAN|7.406|||TWO_SIDED|90.0|-13.948|11.04||||||Week 10: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||11.040|-13.948|
72546537|NCT00601484|144622308|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-7.83|STANDARD_ERROR_OF_MEAN|9.352|||TWO_SIDED|90.0|-23.884|8.234||||||Week 16: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||8.234|-23.884|
72580602|NCT00276484|144690997|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-16.5|STANDARD_ERROR_OF_MEAN|1.7|<|0.001||95.0|-19.9|-13.1|||ANCOVA|Model terms: treatment and baseline LDL-C:HDL-C value||||-13.1|-19.9|<0.001
72580603|NCT00276484|144690998|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-11.0|STANDARD_ERROR_OF_MEAN|1.4|<|0.001||95.0|-13.8|-8.2|||ANCOVA|Model terms: treatment and baseline Apo B:Apo A-I value||||-8.2|-13.8|<0.001
72580604|NCT00276484|144690999|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-14.5|STANDARD_ERROR_OF_MEAN|-1.6|<|0.001||95.0|-17.7|-11.3|||ANCOVA|Model terms: treatment and baseline non-HDL-C:HDL-C value||||-11.3|-17.7|<0.001
72580605|NCT00276484|144691000|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.8||||0.174||95.0|-17.1|3.4|||Longitudinal Data Analysis (LDA)|LDA method of Liang and Zeger with model terms: treatment, time, and the interaction of time by treatment.|Data for analysis was transformed by the natural log and the difference in geometric mean % change from BL calculated based on the difference in the back-transformed least squares means.|||3.4|-17.1|0.174
72580606|NCT00276484|144691001|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|8.37|||<|0.001||95.0|5.45|12.84|||Regression, Logistic|Model terms: treatment and baseline LDL-C value||||12.84|5.45|<0.001
72546538|NCT00601484|144622309|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|5.064|||||TWO_SIDED|90.0|1.709|15.007||||||Week 6: Analysis was based on proportional odds analysis, to determine the odds ratio for the odds of responding (compared to not responding) on Tanezumab vs placebo.||15.007|1.709|
72546539|NCT00601484|144622309|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.722|||||TWO_SIDED|90.0|0.756|9.795||||||Week 16: Analysis was based on proportional odds analysis, to determine the odds ratio for the odds of responding (compared to not responding) on Tanezumab vs placebo.||9.795|0.756|
72580607|NCT04688671|144691010|SUPERIORITY||Mean Difference (Final Values)|0.18|STANDARD_ERROR_OF_MEAN|0.302||0.5605|TWO_SIDED|90.0|-0.32|0.68|||Mixed Models Analysis|||||0.68|-0.32|0.5605
72546540|NCT01463683|144622332|NON_INFERIORITY_OR_EQUIVALENCE|Incidence of seroprotection with V232-2XP SC is non-inferior to V232-1XP SC if the lower bound of the 95% confidence interval of the difference is greater than -10%|Difference in percentage of participants|7.6|||||TWO_SIDED|95.0|1.9|13.6|||Miettinen & Nurminen|||||13.6|1.9|
72546541|NCT01463683|144622333|SUPERIORITY_OR_OTHER||Difference in percentage of participants|4.9||||0.162|TWO_SIDED|95.0|-2.0|11.9|||Miettinen & Nurminen|||||11.9|-2.0|0.162
72546542|NCT01463683|144622333|SUPERIORITY_OR_OTHER||Difference in percentage of participants|11.0||||0.028|TWO_SIDED|95.0|1.1|21.6|||Miettinen & Nurminen|||||21.6|1.1|0.028
72546543|NCT01463683|144622333|SUPERIORITY_OR_OTHER||Difference in percentage of participants|6.0||||0.246|TWO_SIDED|95.0|-4.0|16.8|||Miettinen & Nurminen|||||16.8|-4.0|0.246
72546544|NCT01463683|144622334|SUPERIORITY_OR_OTHER||Difference in percentage of participants|-0.7||||0.659|TWO_SIDED|95.0|-3.8|2.4|||Miettinen & Nurminen|||||2.4|-3.8|0.659
72546545|NCT01463683|144622334|SUPERIORITY_OR_OTHER||Difference in percentage of participants|-1.6||||0.459|TWO_SIDED|95.0|-7.7|2.2|||Miettinen & Nurminen|||||2.2|-7.7|0.459
72580608|NCT04055740|144691020|SUPERIORITY|||||||0.2201|||||||Spearman Correlation Coefficient|This test measures correlation of avg ILA grade per patient with total time of lead extraction. Average ILA grade of all patients in outcome measures.||H0: rho = 0 Spearman correlation coefficient calculated between average ILA grade and total time of lead extraction||||0.2201
72580609|NCT04055740|144691020|SUPERIORITY|||||||0.5157|||||||Spearman Correlation Coefficient|This measures correlation of avg ILA grade per patient with total laser pulsations used for extraction. Avg ILA grade of patients in outcome measures.||H0: rho = 0 Spearman Correlation coefficient calculated between average ILA grades and laser pulsations||||0.5157
72546546|NCT01463683|144622334|SUPERIORITY_OR_OTHER||Difference in percentage of participants|-0.9||||0.686|TWO_SIDED|95.0|-7.1|3.0|||Miettinen & Nurminen|||||3.0|-7.1|0.686
72546547|NCT04345471|144622341|SUPERIORITY|To adjust for the multiplicity, only when the superiority of MD-120 50 mg to Placebo was verified, the superiority of MD-120 100 mg to Placebo was tested.|LS mean difference|-0.6||||0.509|TWO_SIDED|95.0|-2.5|1.2||A priori threshold for statistical significance is p\<0.05, 2-sided.|MMRM|||||1.2|-2.5|0.509
72546548|NCT04345471|144622341|SUPERIORITY|To adjust for the multiplicity, only when the superiority of MD-120 50 mg to Placebo was verified, the superiority of MD-120 100 mg to Placebo was tested.|LS mean difference|-1.4||||0.131|TWO_SIDED|95.0|-3.3|0.4||A priori threshold for statistical significance is p\<0.05, 2-sided. The value was based on the post-hoc analysis by not taking into account the multiplicity.|MMRM|||||0.4|-3.3|0.131
72546549|NCT04345471|144622343|SUPERIORITY||LS mean difference|-0.2||||0.811|TWO_SIDED|95.0|-1.5|1.2||A priori threshold for statistical significance is p\<0.05, 2-sided.|MMRM|||||1.2|-1.5|0.811
72546550|NCT04345471|144622343|SUPERIORITY||LS mean difference|-0.5||||0.424|TWO_SIDED|95.0|-1.9|0.8||A priori threshold for statistical significance is p\<0.05, 2-sided.|MMRM|||||0.8|-1.9|0.424
72546551|NCT00717977|144622370|SUPERIORITY_OR_OTHER|||||||0.009||95.0||||Adjusted for CGM device type. Age was analyzed as continuous.|Regression, Linear|||The associations of mean sensor glucose and glucose variability measures with age were assessed using least-squares regression models adjusting for device type.||||0.009
72546552|NCT00717977|144622371|SUPERIORITY_OR_OTHER|||||||0.04||95.0||||Adjusted for CGM device type. Age was analyzed as continuous.|Regression, Linear|||The associations of mean sensor glucose and glucose variability measures with age were assessed using least-squares regression models adjusting for device type.||||0.04
72546553|NCT00717977|144622372|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Adjusted for device type. Age was analyzed as continuous.|Regression, Linear|||The associations of mean sensor glucose and glucose variability measures with age were assessed using least-squares regression models adjusting for device type.||||<0.001
72546554|NCT02780661|144622404|OTHER||Least square (LS) mean difference|-0.86||||0.0144|TWO_SIDED|95.0|-1.53|-0.196||Log10 change from baseline in aerobic bacteria microbial count as response variable, treatment and period as fixed effect, participant level and period level pre-treatment microbial count as covariates and participant as random effect.|ANCOVA||Difference is first named treatment minus second named treatment in log10{(count+1)/(baseline+1)} such that a negative difference favors the first named treatment.|H0: There is no treatment difference between daily and weekly product use. H1: There is a treatment difference between daily and weekly product use.||-0.196|-1.530|0.0144
72546555|NCT02780661|144622405|OTHER||LS mean difference|-0.48||||0.1879|TWO_SIDED|95.0|-1.23|0.261||Log10 change from baseline in anaerobic bacteria microbial count as response variable, treatment and period as fixed effect, participant level and period level pre-treatment microbial count as covariates and participant as random effect.|ANCOVA||Difference is first named treatment minus second named treatment in log10{(count+1)/(baseline+1)} such that a negative difference favors the first named treatment.|H0: There is no treatment difference between daily and weekly product use. H1: There is a treatment difference between daily and weekly product use.||0.261|-1.230|0.1879
72546556|NCT00494975|144622410|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.94|STANDARD_ERROR_OF_MEAN|0.32|<|0.05|TWO_SIDED|95.0|0.31|1.56|||generalized estimating equations (GEE)|||The VAS score of pruritus intensity was recorded for each participant at baseline and weekly until week 12 so that each one had 12 repeatedly measured data scores. To investigate the predictive effects of age, sex, comorbid diseases, phototherapy, and results of blood laboratory exams on the intensity of pruritus, marginal linear regression model was fitted to the repeatedly measured VAS score data using the generalized estimating equations (GEE) method.||1.56|0.31|<0.05
72546557|NCT01806688|144622412|EQUIVALENCE|The study is designed to detect a 10.0% difference in area under the curve (AUC) appetite ratings between foods. The required number of Participants is 38.|||||<|0.05|||||||ANCOVA|Sources of variation included in the model: snack, visit number, baseline score, visit number × snack, and snack × overweight.||Items #1 were compared to each other and Items #2 were compared to each other||||<0.05
72546558|NCT01806688|144622413|EQUIVALENCE|The study is designed to detect a 10.0% difference in area under the curve (AUC) appetite ratings between foods. The required number of Participants is 38.|||||<|0.05|||||||ANCOVA|Sources of variation included in the model: snack, visit number, baseline score, visit number × snack, and snack × overweight.||Items #1 were compared to each other and Items #2 were compared to each other||||<0.05
72546559|NCT01806688|144622415|EQUIVALENCE|The study is designed to detect a 10.0% difference in area under the curve (AUC) appetite ratings between foods. The required number of Participants is 38.|||||<|0.05|||||||ANCOVA|Sources of variation included in the model: snack, visit number, baseline score, visit number × snack, and snack × overweight.||Items #1 were compared to each other and Items #2 were compared to each other||||<0.05
72546560|NCT02232074|144622430|SUPERIORITY||Odds Ratio (OR)|0.82||||0.77|TWO_SIDED|95.0|0.21|3.14||a priori threshold for statistical significance p\<0.05|Regression, Logistic|||Compared to the control group, the Breast cancer INTERVENTION group will be more likely to have timely first treatment (i.e. receipt of first treatment within 90 days of diagnosis).||3.14|0.21|0.77
72580610|NCT01525329|144691022|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.007|||||||t-test, 2 sided|||||||< 0.007
72580611|NCT01525329|144691022|SUPERIORITY_OR_OTHER_LEGACY|||||||0.08|||||||t-test, 2 sided|||||||0.080
72580612|NCT01525329|144691023|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
72580613|NCT01525329|144691023|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
72546561|NCT02232074|144622431|SUPERIORITY||Odds Ratio (OR)|4.0||||0.26|TWO_SIDED|95.0|0.35|45.4||a priori threshold for statistical significance p\<0.05|Regression, Logistic|||Compared to the control group, the Lung cancer INTERVENTION group will be more likely to have timely first treatment (i.e. receipt of first treatment within 90 days of diagnosis).||45.4|0.35|0.26
72546562|NCT02232074|144622432|SUPERIORITY||Median Difference (Final Values)|-0.27|STANDARD_ERROR_OF_MEAN|0.42||0.53|TWO_SIDED|||||a priori threshold for statistical significance p\<0.05|Regression, Linear|Adjusting for baseline Distress Thermometer scores.||Compared to the control group, the Breast cancer INTERVENTION group will have less distress at 3 months post-enrollment||||0.53
72546563|NCT02232074|144622433|SUPERIORITY||Median Difference (Final Values)|-1.32|STANDARD_ERROR_OF_MEAN|1.62||0.43|TWO_SIDED|||||Adjusting for baseline Distress Thermometer scores.|Regression, Linear|||Compared to the control group, the LUNG cancer INTERVENTION group will have less distress at 3 months post-enrollment||||0.43
72546564|NCT02232074|144622434|SUPERIORITY||Median Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.45||0.18|TWO_SIDED|||||a priori threshold for statistical significance p\<0.05|Regression, Linear|Adjusting for baseline Distress Thermometer scores.||Compared to the control group, the Breast cancer INTERVENTION group will have less distress at 6 months post-enrollment||||0.18
72546565|NCT02232074|144622435|SUPERIORITY||Median Difference (Final Values)|-1.33|STANDARD_ERROR_OF_MEAN|1.29||0.33|TWO_SIDED|||||a priori threshold for statistical significance p\<0.05|Regression, Linear|Adjusting for baseline Distress Thermometer scores.||Compared to the control group, the Lung cancer INTERVENTION group will have less distress at 6 months post-enrollment||||0.33
72546566|NCT02232074|144622436|SUPERIORITY||Median Difference (Final Values)|0.03|STANDARD_ERROR_OF_MEAN|0.07||0.68|TWO_SIDED|||||a priori threshold for statistical significance p\<0.05|Regression, Linear|||||||0.68
72580614|NCT02414958|144691034|SUPERIORITY||Mean Difference (Final Values)|-0.54|STANDARD_ERROR_OF_MEAN|0.06|<|0.0001|TWO_SIDED|97.5|-0.66|-0.41|||Mixed effect Model Repeated Measures||Mean Difference= Empagliflozin 10 milligram (mg) adjusted mean - Placebo matching Empagliflozin adjusted mean.|Model Mixed effect Model Repeated Measures (MMRM) included the fixed categorical effects of treatment, pre-existing insulin therapy, visit , and treatment-by-visit interaction, as well as the continuous, fixed covariates of baseline HbA1c, baseline estimated glomerular filtration rate (eGFR), and baseline HbA1c-by- visit interaction. Patient was included as random effect. An unstructured covariance structure was used to model the within-patient measurements.||-0.41|-0.66|<0.0001
72546567|NCT02232074|144622437|SUPERIORITY||Median Difference (Final Values)|-0.18|STANDARD_ERROR_OF_MEAN|0.15||0.26|TWO_SIDED|||||a priori threshold for statistical significance p\<0.05|Regression, Linear|||||||0.26
72580615|NCT02414958|144691034|SUPERIORITY||Mean Difference (Final Values)|-0.53|STANDARD_ERROR_OF_MEAN|0.06|<|0.0001|TWO_SIDED|97.5|-0.66|-0.41|||MMRM||Mean Difference= Empagliflozin 25 milligram (mg) adjusted mean - Placebo matching Empagliflozin adjusted mean|Model MMRM included the fixed categorical effects of treatment, pre-existing insulin therapy, visit, and treatment-by- visit interaction, as well as the continuous, fixed covariates of baseline HbA1c, baseline eGFR, and baseline HbA1c-by- visit interaction. Patient was included as random effect. An unstructured covariance structure was used to model the within-patient measurements.||-0.41|-0.66|<0.0001
72546568|NCT02232074|144622438|SUPERIORITY||Median Difference (Final Values)|0.71|STANDARD_ERROR_OF_MEAN|1.43||0.62|TWO_SIDED|||||a priori threshold for statistical significance p\<0.05|Regression, Linear|||Compared to the control group, the Breast cancer INTERVENTION group will be more satisfied with patient navigation at 6 months post-enrollment||||0.62
72580616|NCT02414958|144691035|SUPERIORITY||Mean Difference (Final Values)|-0.53|STANDARD_ERROR_OF_MEAN|0.06|<|0.0001|TWO_SIDED|97.5|-0.65|-0.4|||MMRM||Mean Difference= Empagliflozin 10 milligram (mg) adjusted mean - Placebo matching Empagliflozin adjusted mean.|Model MMRM includes baseline HbA1c, baseline eGFR as linear covariates and baseline pre-existing insulin therapy, treatment, visit, visit by treatment interaction, baseline HbA1c by visit interaction as fixed effects. Patient is included as random effect. An unstructured covariance structure was used to model the within-patient measurements.||-0.40|-0.65|<0.0001
72580617|NCT02414958|144691035|SUPERIORITY||Mean Difference (Final Values)|-0.51|||<|0.0001|TWO_SIDED|97.5|-0.64|-0.39|||MMRM||Mean Difference= Empagliflozin 25 milligram (mg) adjusted mean - Placebo matching Empagliflozin adjusted mean.|Model MMRM includes baseline HbA1c, baseline eGFR as linear covariates and baseline pre-existing insulin therapy, treatment, visit, visit by treatment interaction, baseline HbA1c by visit interaction as fixed effects. Patient is included as random effect. An unstructured covariance structure was used to model the within-patient measurements||-0.39|-0.64|<0.0001
72546569|NCT02232074|144622439|SUPERIORITY||Median Difference (Final Values)|1.25|STANDARD_ERROR_OF_MEAN|2.91||0.69|TWO_SIDED|||||a priori threshold for statistical significance p\<0.05|Regression, Linear|||Compared to the control group, the Lung cancer INTERVENTION group will be more satisfied with patient navigation at 6 months post-enrollment||||0.69
72546570|NCT02232074|144622440|SUPERIORITY||Median Difference (Final Values)|0.33|STANDARD_ERROR_OF_MEAN|0.59||0.58|TWO_SIDED|||||a priori threshold for statistical significance p\<0.05|Regression, Linear|adjusting for baseline Case scores.||Compared to the control group, the breast cancer INTERVENTION group would have higher self-efficacy was adjusting for baseline self-efficacy scores.||||0.58
72546571|NCT02232074|144622441|SUPERIORITY||Median Difference (Final Values)|4.2|STANDARD_ERROR_OF_MEAN|2.21||0.09|TWO_SIDED||||||Regression, Linear|adjusting for baseline Case scores.||Compared to the control group, the lung cancer INTERVENTION group would have higher self-efficacy was adjusting for baseline self-efficacy scores.||||0.09
72546572|NCT02232074|144622442|SUPERIORITY||Odds Ratio (OR)|0.85||||0.79|TWO_SIDED|95.0|0.28|2.79||a priori threshold for statistical significance p\<0.05|Regression, Logistic|||We hypothesize that compared to the control group, the Breast cancer INTERVENTION group will receive quality care (i.e. receipt of radiation within one year of diagnosis).||2.79|0.28|0.79
72546573|NCT02232074|144622443|SUPERIORITY||Median Difference (Final Values)|0.19|STANDARD_ERROR_OF_MEAN|0.5||0.71|TWO_SIDED|||||a priori threshold for statistical significance p\<0.05|Regression, Linear|||We hypothesize that compared to the control group, the Breast cancer INTERVENTION group will have less distress at 12 months post-enrollment.||||0.71
72580618|NCT02414958|144691036|SUPERIORITY||Adjusted Rate Ratio (%)|0.744||||0.0623|TWO_SIDED|97.75|0.518|1.069|||Negative binomial model||Empagliflozin 10 milligram (mg) adjusted rate/Placebo matching Empagliflozin adjusted rate.|For week 5 to 26, negative binomial model includes baseline rate of hypoglycaemia, baseline HbA1c, and baseline eGFR as linear covariates and baseline pre-existing insulin therapy and treatment as fixed effects. Log (time at risk \[days\]) was used as offset.||1.069|0.518|0.0623
72580619|NCT02414958|144691036|SUPERIORITY||Adjusted Rate Ratio (%)|0.726||||0.048|TWO_SIDED|97.75|0.502|1.501|||Negative binomial model||Empagliflozin 25 milligram (mg) adjusted rate/Placebo matching Empagliflozin adjusted rate.|For week 5 to 26, negative binomial model includes baseline rate of hypoglycaemia, baseline HbA1c, and baseline eGFR as linear covariates and baseline pre-existing insulin therapy and treatment as fixed effects. Log (time at risk \[days\]) was used as offset||1.501|0.502|0.0480
72580620|NCT02414958|144691036|SUPERIORITY||Adjusted Rate Ratio (%)|0.774||||0.0972|TWO_SIDED|95.0|0.572|1.048||This is a nominal p-value.|Negative binomial model||Empagliflozin 10 milligram (mg) adjusted rate/Placebo matching Empagliflozin adjusted rate.|For week 1 to 26, negative binomial model includes baseline rate of hypoglycaemia, baseline HbA1c, and baseline eGFR as linear covariates and baseline pre-existing insulin therapy and treatment as fixed effects. Log (time at risk \[days\]) was used as offset.||1.048|0.572|0.0972
72580621|NCT02414958|144691036|SUPERIORITY||Adjusted Rate Ratio (%)|0.782||||0.118|TWO_SIDED|97.75|0.575|1.064||Negative binomial model|MMRM||Empagliflozin 25 milligram (mg) adjusted rate/Placebo matching Empagliflozin adjusted rate.|For week 1 to 26, negative binomial model includes baseline rate of hypoglycaemia, baseline HbA1c, and baseline eGFR as linear covariates and baseline pre-existing insulin therapy and treatment as fixed effects. Log (time at risk \[days\]) was used as offset.||1.064|0.575|0.1180
72546574|NCT02232074|144622444|SUPERIORITY||Median Difference (Final Values)|-1.45|STANDARD_DEVIATION|2.71||0.61|TWO_SIDED|||||a priori threshold for statistical significance p\<0.05|Regression, Linear|||We hypothesize that compared to the control group, the Lung cancer INTERVENTION group will have less distress at 12 months post-enrollment||||0.61
72580622|NCT02414958|144691037|SUPERIORITY||Mean Difference (Final Values)|-2.69|STANDARD_ERROR_OF_MEAN|0.29|<|0.0001|TWO_SIDED|99.75|-3.57|-1.8|||MMRM||Mean Difference= Empagliflozin 10 milligram (mg) adjusted mean - Placebo matching Empagliflozin adjusted mean.|Model MMRM includes baseline weight, baseline eGFR, baseline HbA1c as linear covariate and baseline pre-existing insulin therapy, treatment, visit, visit by treatment interaction, baseline weight by visit interaction as fixed effect. An unstructured covariance structure was used to model the within-patient measurements.||-1.80|-3.57|<0.0001
72546575|NCT02232074|144622445|SUPERIORITY||Mean Difference (Final Values)|0.06|STANDARD_DEVIATION|0.08||0.46|TWO_SIDED|||||a priori threshold for statistical significance p\<0.05|Regression, Linear|||||||0.46
72546576|NCT02232074|144622446|SUPERIORITY||Median Difference (Final Values)|-0.03|STANDARD_DEVIATION|0.2||0.89|TWO_SIDED|||||a priori threshold for statistical significance p\<0.05|Regression, Linear|||||||0.89
72546577|NCT02232074|144622447|SUPERIORITY||Mean Difference (Final Values)|2.38|STANDARD_DEVIATION|1.66||0.16|TWO_SIDED|||||a priori threshold for statistical significance p\<0.05|Regression, Linear|||||||0.16
72546578|NCT02232074|144622448|SUPERIORITY||Mean Difference (Final Values)|-4.83|STANDARD_DEVIATION|2.93||0.16|TWO_SIDED|||||a priori threshold for statistical significance p\<0.05|Regression, Linear|||||||0.16
72546579|NCT02232074|144622449|SUPERIORITY||Mean Difference (Final Values)|1.14|STANDARD_DEVIATION|0.75||0.13|TWO_SIDED|||||a priori threshold for statistical significance p\<0.05|Regression, Linear|||||||0.13
72546580|NCT02232074|144622450|SUPERIORITY||Mean Difference (Final Values)|0.97|STANDARD_DEVIATION|3.7||0.8|TWO_SIDED|||||a priori threshold for statistical significance p\<0.05|Regression, Linear|||||||0.80
72546581|NCT02322879|144622475|SUPERIORITY|||||||0.59|||||||Chi-squared|||||||0.59
72546582|NCT02637076|144622488|OTHER|||||||0.31|||||||repeated measures ANOVA|F(2,36)=1.26||||||0.31
72546583|NCT02637076|144622493|OTHER|||||||0.748|||||||repeated measures ANOVA|||||||0.748
72546584|NCT00810732|144622500|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) Mean Difference|-0.56|STANDARD_ERROR_OF_MEAN|0.19||0.004|TWO_SIDED|95.0|-0.94|-0.19|||ANCOVA|||||-0.19|-0.94|0.0040
72546585|NCT00810732|144622500|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.61|STANDARD_ERROR_OF_MEAN|0.19||0.0018|TWO_SIDED|95.0|-0.99|-0.24|||ANCOVA|||||-0.24|-0.99|0.0018
72546586|NCT00810732|144622500|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.05|STANDARD_ERROR_OF_MEAN|0.19||0.7945|TWO_SIDED|95.0|-0.33|0.43|||ANCOVA|||||0.43|-0.33|0.7945
72546587|NCT00810732|144622501|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-3.5|STANDARD_ERROR_OF_MEAN|1.3||0.0087|TWO_SIDED|95.0|-6.08|-0.91|||ANCOVA|||Mean Systemic Arterial BP: Week 3||-0.91|-6.08|0.0087
72546588|NCT00810732|144622501|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.92|STANDARD_ERROR_OF_MEAN|1.3||0.1424|TWO_SIDED|95.0|-4.5|0.66|||ANCOVA|||Mean Systemic Arterial BP: Week 3||0.66|-4.50|0.1424
72546589|NCT00810732|144622501|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.58|STANDARD_ERROR_OF_MEAN|1.29||0.2277|TWO_SIDED|95.0|-4.15|1.0|||ANCOVA|||Mean Systemic Arterial BP: Week 3||1.00|-4.15|0.2277
72546590|NCT00810732|144622501|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-2.56|STANDARD_ERROR_OF_MEAN|1.81||0.1599|TWO_SIDED|95.0|-6.16|1.03|||ANCOVA|||Systolic Blood Pressure: Week 3||1.03|-6.16|0.1599
72546591|NCT00810732|144622501|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.07|STANDARD_ERROR_OF_MEAN|1.8||0.5545|TWO_SIDED|95.0|-4.66|2.52|||ANCOVA|||Systolic Blood Pressure: Week 3||2.52|-4.66|0.5545
72546592|NCT00810732|144622501|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.49|STANDARD_ERROR_OF_MEAN|1.8||0.4095|TWO_SIDED|95.0|-5.08|2.09|||ANCOVA|||Systolic Blood Pressure: Week 3||2.09|-5.08|0.4095
72546593|NCT00810732|144622501|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-4.08|STANDARD_ERROR_OF_MEAN|1.21||0.0012|TWO_SIDED|95.0|-6.49|-1.67|||ANCOVA|||Diastolic Blood Pressure: Week 3||-1.67|-6.49|0.0012
72546594|NCT00810732|144622501|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-2.98|STANDARD_ERROR_OF_MEAN|1.21||0.0159|TWO_SIDED|95.0|-5.38|-0.57|||ANCOVA|||Diastolic Blood Pressure: Week 3||-0.57|-5.38|0.0159
72546595|NCT00810732|144622501|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.1|STANDARD_ERROR_OF_MEAN|1.21||0.3627|TWO_SIDED|95.0|-3.51|1.3|||ANCOVA|||Diastolic Blood Pressure: Week 3||1.30|-3.51|0.3627
72546596|NCT00810732|144622501|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-3.36|STANDARD_ERROR_OF_MEAN|1.16||0.0057|TWO_SIDED|95.0|-5.69|-1.03|||ANCOVA|||Mean Systemic Arterial BP: Week 6||-1.03|-5.69|0.0057
72546597|NCT00810732|144622501|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.53|STANDARD_ERROR_OF_MEAN|1.16||0.6503|TWO_SIDED|95.0|-2.86|1.8|||ANCOVA|||Mean Systemic Arterial BP: Week 6||1.80|-2.86|0.6503
72546598|NCT00810732|144622501|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-2.83|STANDARD_ERROR_OF_MEAN|1.16||0.0183|TWO_SIDED|95.0|-5.16|-0.5|||ANCOVA|||Mean Systemic Arterial BP: Week 6||-0.50|-5.16|0.0183
72546599|NCT00810732|144622501|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-2.81|STANDARD_ERROR_OF_MEAN|1.53||0.0726|TWO_SIDED|95.0|-5.89|0.27|||ANCOVA|||Systolic Blood Pressure (SBP): Week 6||0.27|-5.89|0.0726
72546600|NCT00810732|144622501|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.07|STANDARD_ERROR_OF_MEAN|1.53||0.9661|TWO_SIDED|95.0|-3.01|3.14|||ANCOVA|||Systolic Blood Pressure (SBP): Week 6||3.14|-3.01|0.9661
72546601|NCT00810732|144622501|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-2.88|STANDARD_ERROR_OF_MEAN|1.53||0.0656|TWO_SIDED|95.0|-5.94|0.19|||ANCOVA|||Systolic Blood Pressure (SBP): Week 6||0.19|-5.94|0.0656
72546602|NCT00810732|144622501|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-3.16|STANDARD_ERROR_OF_MEAN|1.11||0.0068|TWO_SIDED|95.0|-5.39|-0.92|||ANCOVA|||Diastolic Blood Pressure (DBP): Week 6||-0.92|-5.39|0.0068
72546603|NCT00810732|144622501|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.99|STANDARD_ERROR_OF_MEAN|1.11||0.376|TWO_SIDED|95.0|-3.22|1.24|||ANCOVA|||Diastolic Blood Pressure (DBP): Week 6||1.24|-3.22|0.3760
72546604|NCT00810732|144622501|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-2.16|STANDARD_ERROR_OF_MEAN|1.11||0.0572|TWO_SIDED|95.0|-4.4|0.07|||ANCOVA|||Diastolic Blood Pressure (DBP): Week 6||0.07|-4.40|0.0572
72546605|NCT00810732|144622502|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.03|STANDARD_ERROR_OF_MEAN|0.21||0.8823|TWO_SIDED|95.0|-0.39|0.45|||ANCOVA|||Week 3||0.45|-0.39|0.8823
72580623|NCT02414958|144691037|SUPERIORITY||Mean Difference (Final Values)|-3.27|||<|0.0001|TWO_SIDED|99.75|-4.15|-2.39|||MMRM||Mean Difference= Empagliflozin 25 milligram (mg) adjusted mean - Placebo matching Empagliflozin adjusted mean.|Model MMRM includes baseline weight, baseline eGFR, baseline HbA1c as linear covariate and baseline pre-existing insulin therapy, treatment, visit, visit by treatment interaction, baseline weight by visit interaction as fixed effect. An unstructured covariance structure was used to model the within-patient measurements.||-2.39|-4.15|<0.0001
72546606|NCT00810732|144622502|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.01|STANDARD_ERROR_OF_MEAN|0.21||0.9457|TWO_SIDED|95.0|-0.41|0.43|||ANCOVA|||Week 3||0.43|-0.41|0.9457
72546607|NCT00810732|144622502|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.02|STANDARD_ERROR_OF_MEAN|0.21||0.9358|TWO_SIDED|95.0|-0.4|0.44|||ANCOVA|||Week 3||0.44|-0.40|0.9358
72546608|NCT00810732|144622502|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.64|STANDARD_ERROR_OF_MEAN|0.19||0.0022|TWO_SIDED|95.0|-1.03|-0.25|||ANCOVA|||Week 6||-0.25|-1.03|0.0022
72546609|NCT00810732|144622502|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.03|STANDARD_ERROR_OF_MEAN|0.19||0.8956|TWO_SIDED|95.0|-0.41|0.36|||ANCOVA|||Week 6||0.36|-0.41|0.8956
72546610|NCT00810732|144622502|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.61|STANDARD_ERROR_OF_MEAN|0.19||0.003|TWO_SIDED|95.0|-1.0|-0.23|||ANCOVA|||Week 6||-0.23|-1.00|0.0030
72546611|NCT03734237|144622514|EQUIVALENCE|Null Hypothesis: RR=1, Alternative hypothesis: RR not equal to 1|Risk Ratio (RR)|-26.7||||0.1412|TWO_SIDED|95.0|-73.7|7.6|||Chi-squared|||Relative vaccine effectiveness with the outcome laboratory confirmed influenza identified via surveillance and/or abstracted from clinical records.||7.6|-73.7|0.1412
72546612|NCT03734237|144622514|EQUIVALENCE|Null Hypothesis: RR=1, Alternative hypothesis: RR not equal to 1.|Risk Ratio (RR)|-13.1||||0.4552|TWO_SIDED|95.0|-56.4|18.2|||Chi-squared|||Relative vaccine effectiveness with the outcome laboratory confirmed influenza identified via surveillance and/or abstracted from clinical records.||18.2|-56.4|0.4552
72546613|NCT02833415|144622533|OTHER|Differences of Least Squares Means|Differences of Least Squares Means|0.9398|STANDARD_ERROR_OF_MEAN|0.2941||0.0053|TWO_SIDED||||||Mixed Models Analysis|||Baseline to Followup||||0.0053
72546614|NCT02833415|144622533|OTHER|Differences of Least Squares Means|Differences of Least Squares Means|0.152|STANDARD_ERROR_OF_MEAN|0.2424||0.5394|TWO_SIDED||||||Mixed Models Analysis|||Baseline to Followup||||0.5394
72546615|NCT01769378|144622536|SUPERIORITY_OR_OTHER||LS Squares Mean Difference|-1.27|STANDARD_ERROR_OF_MEAN|0.15|<|0.001|TWO_SIDED|95.0|-1.57|-0.97|||Mixed Models Analysis|||||-0.97|-1.57|<0.001
72546616|NCT01769378|144622537|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|11.37|||<|0.001|TWO_SIDED|95.0|3.82|33.84|||Regression, Logistic|Sequential gatekeeping strategy was used to adjust for multiplicity.||\<7.0% HbA1c||33.84|3.82|<0.001
72546617|NCT01769378|144622537|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|11.45|||<|0.001|TWO_SIDED|95.0|3.71|35.34|||Regression, Logistic|||≤6.5% HbA1c||35.34|3.71|<0.001
72546618|NCT01769378|144622538|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-33.54|STANDARD_ERROR_OF_MEAN|6.6|<|0.001|TWO_SIDED|95.0|-46.55|-20.53|||ANCOVA|Sequential gatekeeping strategy was used to adjust for multiplicity.||||-20.53|-46.55|<0.001
72546619|NCT01769378|144622539|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.68|STANDARD_ERROR_OF_MEAN|0.43||0.12|TWO_SIDED|95.0|-1.53|0.18|||Mixed Models Analysis|Sequential gatekeeping strategy was used to adjust for multiplicity.||||0.18|-1.53|0.120
72546620|NCT01769378|144622540|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.23|STANDARD_ERROR_OF_MEAN|0.16||0.161|TWO_SIDED|95.0|-0.54|0.09||No adjustment for multiplicity|Mixed Models Analysis|||||0.09|-0.54|0.161
72546621|NCT01769378|144622541|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-28.95|STANDARD_ERROR_OF_MEAN|4.85|<|0.001|TWO_SIDED|95.0|-38.49|-19.4|||Mixed Models Analysis|||||-19.40|-38.49|<0.001
72546622|NCT02324972|144622552|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02||||0.636|TWO_SIDED|95.0|-1.3|1.25|||ANCOVA|||A sample size of 20 subjects per group was assumed to have 80% power to allow detection of a statistically significant difference in change from baseline in TLSS between the 2 groups, if the effect size was approximately less than or equal to 0.9. This is equivalent to detecting a difference of -4.5 between the 2 groups with a common standard deviation of 5. The primary analysis was doing using last observation carried forward (LOCF) imputed data.||1.25|-1.30|0.636
72546623|NCT02324972|144622553|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.12||||0.677|TWO_SIDED|95.0|-0.44|0.68|||ANOVA|||||0.68|-0.44|0.677
72546624|NCT02324972|144622554|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.219||||0.802|TWO_SIDED|95.0|-1.983|1.544|||ANOVA|||||1.544|-1.983|0.802
72546625|NCT02324972|144622555|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.108||||0.976|TWO_SIDED|95.0|-7.076|7.292|||ANOVA|||||7.292|-7.076|0.976
72546626|NCT02324972|144622556|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.52||||0.233|TWO_SIDED|95.0|-1.68|6.72|||ANOVA|||||6.72|-1.68|0.233
72546627|NCT02398188|144622620|SUPERIORITY|||||||0.397|||||||Cochran-Mantel-Haenszel|||||||0.397
72546628|NCT02398188|144622621|SUPERIORITY|||||||0.379|||||||Cochran-Mantel-Haenszel|||||||0.379
72546629|NCT00782509|144622623|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.151|STANDARD_ERROR_OF_MEAN|0.017|<|0.0001||95.0|0.116|0.185|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.185|0.116|<0.0001
72546630|NCT00782509|144622623|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.143|STANDARD_ERROR_OF_MEAN|0.017|<|0.0001||95.0|0.11|0.177|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.177|0.110|<0.0001
72546631|NCT00782509|144622624|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.047|STANDARD_ERROR_OF_MEAN|0.019||0.0116||95.0|0.011|0.084|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.084|0.011|0.0116
72546632|NCT00782509|144622624|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.048|STANDARD_ERROR_OF_MEAN|0.019||0.0095||95.0|0.012|0.085|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.085|0.012|0.0095
72546633|NCT00782509|144622625|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.11|STANDARD_ERROR_OF_MEAN|0.027|<|0.0001||95.0|0.057|0.162|||ANCOVA|Treatment, tiotropium stratum and baseline as fixed effects|Olo 5 mcg qd minus Placebo|||0.162|0.057|<0.0001
72546634|NCT00782509|144622625|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.089|STANDARD_ERROR_OF_MEAN|0.027||0.0011||95.0|0.036|0.143|||Mixed Models Analysis|Treatment, tiotropium stratum and baseline as fixed effects|Olo 10 mcg qd minus Placebo|||0.143|0.036|0.0011
72580624|NCT02414958|144691038|SUPERIORITY||Mean Difference (Final Values)|11.86|||<|0.0001|TWO_SIDED|99.75|8.78|14.93|||ANCOVA||Mean Difference= Empagliflozin 10 milligram (mg) adjusted mean - Placebo matching Empagliflozin adjusted mean|The analysis of covariance (ANCOVA) model includes baseline time in the target range, baseline HbA1c, and baseline eGFR as linear covariates and baseline pre-existing insulin therapy and treatment as fixed effects.||14.93|8.78|<0.0001
72580625|NCT02414958|144691038|SUPERIORITY||Mean Difference (Final Values)|12.87|STANDARD_ERROR_OF_MEAN|1.01|<|0.0001|TWO_SIDED|99.75|9.81|15.93|||ANCOVA||Mean Difference= Empagliflozin 25 milligram (mg) adjusted mean - Placebo matching Empagliflozin adjusted mean|||15.93|9.81|<0.0001
72580626|NCT02414958|144691039|SUPERIORITY||Mean Difference (Final Values)|-16.92|STANDARD_ERROR_OF_MEAN|1.68|<|0.0001|TWO_SIDED|99.75|-22.04|-11.81|||ANCOVA||Mean Difference= Empagliflozin 10 milligram (mg) adjusted mean - Placebo matching Empagliflozin adjusted mean.|The analysis of covariance (ANCOVA) model includes model includes baseline IQR of glucose, baseline HbA1c, and baseline eGFR as linear covariates and baseline pre-existing insulin therapy and treatment as fixed effects.||-11.81|-22.04|<0.0001
72546635|NCT00782509|144622626|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.164|STANDARD_ERROR_OF_MEAN|0.017|<|0.0001||95.0|0.131|0.197|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.197|0.131|<0.0001
72546636|NCT00782509|144622626|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.171|STANDARD_ERROR_OF_MEAN|0.017|<|0.0001||95.0|0.138|0.204|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.204|0.138|<0.0001
72546637|NCT00782509|144622627|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.163|STANDARD_ERROR_OF_MEAN|0.017|<|0.0001||95.0|0.13|0.197|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.197|0.130|<0.0001
72580627|NCT02414958|144691039|SUPERIORITY||Mean Difference (Final Values)|-19.04|STANDARD_ERROR_OF_MEAN|1.68|<|0.0001|TWO_SIDED|99.75|-24.13|-13.95|||ANCOVA||Mean Difference= Empagliflozin 25 milligram (mg) adjusted mean - Placebo matching Empagliflozin adjusted mean.|The analysis of covariance (ANCOVA) model includes model includes baseline IQR of glucose, baseline HbA1c, and baseline eGFR as linear covariates and baseline pre-existing insulin therapy and treatment as fixed effects.||-13.95|-24.13|<0.0001
72546638|NCT00782509|144622627|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.152|STANDARD_ERROR_OF_MEAN|0.017|<|0.0001||95.0|0.119|0.186|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.186|0.119|<0.0001
72580628|NCT02414958|144691040|SUPERIORITY||Mean Difference (Final Values)|-0.092|STANDARD_ERROR_OF_MEAN|0.009|<|0.0001|TWO_SIDED|99.75|-0.121|-0.063|||MMRM||Mean Difference= Empagliflozin 10 milligram (mg) adjusted mean - Placebo matching Empagliflozin adjusted mean.|Model MMRM includes baseline total daily insulin dose, baseline estimated eGFR, baseline HbA1c as linear covariate and baseline pre-existing insulin therapy, treatment, visit, visit by treatment interaction, baseline total daily insulin dose by visit interaction as fixed effect. An unstructured covariance structure was used to model the within-patient measurements.||-0.063|-0.121|<0.0001
72580629|NCT02414958|144691040|SUPERIORITY||Mean Difference (Final Values)|-0.09|STANDARD_ERROR_OF_MEAN|0.009|<|0.0001|TWO_SIDED|99.75|-0.119|-0.062|||MMRM||Mean Difference= Empagliflozin 25 milligram (mg) adjusted mean - Placebo matching Empagliflozin adjusted mean.|Model MMRM includes baseline total daily insulin dose, baseline estimated eGFR, baseline HbA1c as linear covariate and baseline pre-existing insulin therapy, treatment, visit, visit by treatment interaction, baseline total daily insulin dose by visit interaction as fixed effect. An unstructured covariance structure was used to model the within-patient measurements.||-0.062|-0.119|<0.0001
72580630|NCT02414958|144691041|SUPERIORITY||Mean Difference (Final Values)|-2.1|STANDARD_ERROR_OF_MEAN|1.0||0.0397|TWO_SIDED|99.75|-5.2|1.0|||MMRM||Mean Difference= Empagliflozin 10 milligram (mg) adjusted mean - Placebo matching Empagliflozin adjusted mean.|For SBP, the model MMRM includes baseline SBP seated, baseline estimated eGFR, baseline HbA1c as linear covariate and baseline pre-existing insulin therapy, treatment, visit, treatment by visit interaction, baseline SBP seated by visit interaction as fixed effect. An unstructured covariance structure was used to model the within-patient measurements.||1.0|-5.2|0.0397
72580631|NCT02414958|144691041|SUPERIORITY||Mean Difference (Final Values)|-3.7|STANDARD_ERROR_OF_MEAN|1.0||0.0003|TWO_SIDED|99.75|-6.8|-0.6|||MMRM||Mean Difference= Empagliflozin 25 milligram (mg) adjusted mean - Placebo matching Empagliflozin adjusted mean.|For SBP, the model includes baseline SBP seated, baseline estimated eGFR, baseline HbA1c as linear covariate and baseline pre-existing insulin therapy, treatment, visit, treatment by visit interaction, baseline SBP seated by visit interaction as fixed effect. An unstructured covariance structure was used to model the within-patient measurements.||-0.6|-6.8|0.0003
72412028|NCT04419493|144332155|EQUIVALENCE|Bioequivalence was concluded, if the confidence interval (CI) for the comparison of geometric least squares means ratio was included in the pre-defined equivalence range of 80.00% to 125.00%|Geometric Least Squares Mean ratio (%)|102.2|STANDARD_ERROR_OF_MEAN|10.8|||TWO_SIDED|92.83|94.87|110.1|||||Geometric Least Squares Mean ratio is: Alteplase, TPA-02/Alteplase, TPA-05. Standard Error of the mean is actually the intra-individual geometric coefficient variation.|"The null hypothesis was that the ratio of expected geometric least squares means Alteplase, TPA-02 vs. Alteplase, TPA-05 is less than 80.00% or more than 125.00%.~The statistical model used for the analysis of this endpoints was an analysis of variance (ANOVA) model on the logarithmic scale.~This model included effects accounting for the following sources of variation: sequence, subjects within sequences, period and treatment. All effects were considered as fixed."||110.10|94.87|
72412029|NCT04419493|144332157|EQUIVALENCE|Bioequivalence was concluded, if the confidence interval (CI) for the comparison of geometric least squares means ratio was included in the pre-defined equivalence range of 80.00% to 125.00%|Geometric Least Squares Mean ratio (%)|105.81|STANDARD_ERROR_OF_MEAN|9.3|||TWO_SIDED|92.83|99.18|112.88|||||Geometric Least Squares Mean ratio is: Alteplase, TPA-02/Alteplase, TPA-05. Standard Error of the mean is actually the intra-individual geometric coefficient variation.|"The null hypothesis was that the ratio of expected geometric least squares means Alteplase, TPA-02 vs. Alteplase, TPA-05 is less than 80.00% or more than 125.00%.~The statistical model used for the analysis of this endpoints was an analysis of variance (ANOVA) model on the logarithmic scale.~This model included effects accounting for the following sources of variation: sequence, subjects within sequences, period and treatment. All effects were considered as fixed."||112.88|99.18|
72412030|NCT04419493|144332159|EQUIVALENCE|Bioequivalence was concluded, if the confidence interval (CI) for the comparison of geometric least squares means ratio was included in the pre-defined equivalence range of 80.00% to 125.00% .|Geometric Least Squares Mean ratio (%)|102.17|STANDARD_ERROR_OF_MEAN|10.8|||TWO_SIDED|92.83|94.79|110.12|||||Geometric Least Squares Mean ratio is: Alteplase, TPA-02/Alteplase, TPA-05. Standard Error of the mean is actually the intra-individual geometric coefficient variation.|"The null hypothesis was that the ratio of expected geometric least squares means Alteplase, TPA-02 vs. Alteplase, TPA-05 is less than 80.00% or more than 125.00%.~The statistical model used for the analysis of this endpoints was an analysis of variance (ANOVA) model on the logarithmic scale.~This model included effects accounting for the following sources of variation: sequence, subjects within sequences, period and treatment. All effects were considered as fixed."||110.12|94.79|
72412031|NCT03794089|144332164|SUPERIORITY|||||||0.035||||||a priori threshold for statistical significance was p\<=.05|ANCOVA|||comparisons of groups at post-assessment controls for baseline GAD-7 total scores||||0.035
72412032|NCT03794089|144332165|SUPERIORITY|||||||0.231||||||a priori threshold for statistical significance was p\<=0.05|ANCOVA|||comparisons of groups at post-assessment controls for baseline PHQ-9 total scores||||0.231
72412033|NCT03794089|144332166|SUPERIORITY|Testing null hypothesis of no difference between groups||||||0.393||||||a priori threshold for statistical significance was p\<=0.05|Mixed Models Analysis|||Change in DASS-21 Anxiety subscale total from Baseline to 4 weeks||||0.393
72412034|NCT03794089|144332166|SUPERIORITY|Testing null hypothesis of no difference between groups||||||0.022||||||a priori threshold for statistical significance was p\<=0.05|Mixed Models Analysis|||Change in DASS-21 Anxiety subscale total from Baseline to 8 weeks||||0.022
72412035|NCT03794089|144332166|SUPERIORITY|Testing null hypothesis of no difference between groups||||||0.013||||||a priori threshold for statistical significance was p\<=0.05|Mixed Models Analysis|||Change in DASS-21 Anxiety subscale total from Baseline to 12 weeks||||0.013
72412036|NCT03794089|144332166|SUPERIORITY|Testing null hypothesis of no difference between groups||||||0.049||||||a priori threshold for statistical significance was p\<=0.05|Mixed Models Analysis|||Change in DASS-21 Anxiety subscale total from Baseline to Post assessment (16 weeks)||||0.049
72412037|NCT03794089|144332167|SUPERIORITY|Testing null hypothesis of no difference between groups||||||0.008||||||a priori threshold for statistical significance was p\<=0.05|Mixed Models Analysis|||Change in DASS-21 Depression subscale total from Baseline to 4 weeks||||0.008
72412038|NCT03794089|144332167|SUPERIORITY|Testing null hypothesis of no difference between groups|||||<|0.001||||||a priori threshold for statistical significance was p\<=0.05|Mixed Models Analysis|||Change in DASS-21 Depression subscale total from Baseline to 8 weeks||||<0.001
72412039|NCT03794089|144332167|SUPERIORITY|Testing null hypothesis of no difference between groups|||||<|0.001||||||a priori threshold for statistical significance was p\<=0.05|Mixed Models Analysis|||Change in DASS-21 Depression subscale total from Baseline to 12 weeks||||<0.001
72412040|NCT03794089|144332167|SUPERIORITY|Testing null hypothesis of no difference between groups||||||0.008||||||a priori threshold for statistical significance was p\<=0.05|Mixed Models Analysis|||Change in DASS-21 Depression subscale total from Baseline to Post-assessment (16 weeks)||||0.008
72412041|NCT03794089|144332168|SUPERIORITY|Testing null hypothesis of no difference between groups||||||0.44||||||a priori threshold for statistical significance was p\<=0.05|Mixed Models Analysis|||Change in DASS-21 Stress subscale total from Baseline to 4 weeks||||0.440
72412042|NCT03794089|144332168|SUPERIORITY|Testing null hypothesis of no difference between groups||||||0.022||||||a priori threshold for statistical significance was p\<=0.05|Mixed Models Analysis|||Change in DASS-21 Stress subscale total from Baseline to 8 weeks||||0.022
72412043|NCT03794089|144332168|SUPERIORITY|Testing null hypothesis of no difference between groups||||||0.032||||||a priori threshold for statistical significance was p\<=0.05|Mixed Models Analysis|||Change in DASS-21 Stress subscale total from Baseline to 12 weeks||||0.032
72412044|NCT03794089|144332168|SUPERIORITY|Testing null hypothesis of no difference between groups||||||0.091||||||a priori threshold for statistical significance was p\<=0.05|Mixed Models Analysis|||Change in DASS-21 Stress subscale total from Baseline to Post-assessment (16 weeks)||||0.091
72412045|NCT03794089|144332169|SUPERIORITY|Testing null hypothesis of no difference between groups||||||0.058||||||a priori threshold for statistical significance was p\<=0.05|Mixed Models Analysis|||Change in OASIS total score from Baseline to 4 weeks||||0.058
72412046|NCT03794089|144332169|SUPERIORITY|Testing null hypothesis of no difference between groups||||||0.032||||||a priori threshold for statistical significance was p\<=0.05|Mixed Models Analysis|||Change in OASIS total score from Baseline to 8 weeks||||0.032
72412047|NCT03794089|144332169|SUPERIORITY|Testing null hypothesis of no difference between groups||||||0.007||||||a priori threshold for statistical significance was p\<=0.05|Mixed Models Analysis|||Change in OASIS total score from Baseline to 12 weeks||||0.007
72412048|NCT03794089|144332169|SUPERIORITY|Testing null hypothesis of no difference between groups||||||0.044||||||a priori threshold for statistical significance was p\<=0.05|Mixed Models Analysis|||Change in OASIS total score from Baseline to Post assessment (16 weeks)||||0.044
72412049|NCT03794089|144332170|SUPERIORITY|Testing null hypothesis of no difference between groups||||||0.328||||||a priori threshold for statistical significance was p\<=0.05|Mixed Models Analysis|||Change in ODSIS total from Baseline to 4 weeks||||0.328
72412050|NCT03794089|144332170|SUPERIORITY|Testing null hypothesis of no difference between groups||||||0.148||||||a priori threshold for statistical significance was p\<=0.05|Mixed Models Analysis|||Change in ODSIS total from Baseline to 8 weeks||||0.148
72412051|NCT03794089|144332170|SUPERIORITY|Testing null hypothesis of no difference between groups||||||0.002||||||a priori threshold for statistical significance was p\<=0.05|Mixed Models Analysis|||Change in ODSIS total from Baseline to 12 weeks||||0.002
72412052|NCT03794089|144332170|SUPERIORITY|Testing null hypothesis of no difference between groups||||||0.069||||||a priori threshold for statistical significance was p\<=0.05|Mixed Models Analysis|||Change in ODSIS total from Baseline to Post-assessment (16 weeks)||||0.069
72412053|NCT03794089|144332171|SUPERIORITY|||||||0.928||||||a priori threshold for statistical significance was p\<=0.05|ANCOVA|||comparisons of groups at post-assessment controls for baseline Q-LES-Q-SF total scores||||0.928
72546639|NCT00782509|144622628|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.169|STANDARD_ERROR_OF_MEAN|0.017|<|0.0001||95.0|0.135|0.203|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.203|0.135|<0.0001
72412054|NCT03794089|144332172|SUPERIORITY|||||||0.402||||||a priori threshold for statistical significance was p\<.05|Fisher Exact|degrees of freedom = 1||Testing null hypothesis of no difference between groups||||0.402
72412055|NCT03794089|144332173|SUPERIORITY||||||<|0.001||||||a priori threshold for statistical significance was p\<=.05|t-test, 2 sided|||Testing the null hypothesis of no difference between groups||||<0.001
72412056|NCT03794089|144332174|SUPERIORITY|||||||0.006||||||a priori threshold for statistical significance was p\<=.05|t-test, 2 sided|Used Satterthwaite method given unequal variances||Testing the null hypothesis of no difference between groups||||.006
72412057|NCT03794089|144332175|SUPERIORITY|||||||0.004||||||a priori threshold for statistical significance was p\<=.05|t-test, 2 sided|used Satterthwaite method given unequal variances||Testing the null hypothesis of no difference between groups||||0.004
72412058|NCT03794089|144332176|SUPERIORITY|||||||0.002||||||a priori threshold for statistical significance was p\<=.05|t-test, 2 sided|||Testing the null hypothesis of no difference between groups||||0.002
72546640|NCT00782509|144622628|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.161|STANDARD_ERROR_OF_MEAN|0.017|<|0.0001||95.0|0.127|0.195|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.195|0.127|<0.0001
72546641|NCT00782509|144622629|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.165|STANDARD_ERROR_OF_MEAN|0.018|<|0.0001||95.0|0.131|0.2|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.200|0.131|<0.0001
72546642|NCT00782509|144622629|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.136|STANDARD_ERROR_OF_MEAN|0.018|<|0.0001||95.0|0.102|0.171|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.171|0.102|<0.0001
72546643|NCT00782509|144622630|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.161|STANDARD_ERROR_OF_MEAN|0.018|<|0.0001||95.0|0.127|0.196|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.196|0.127|<0.0001
72546644|NCT00782509|144622630|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.158|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001||95.0|0.123|0.193|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.193|0.123|<0.0001
72412059|NCT00982020|144332199|SUPERIORITY_OR_OTHER|||||||0.15||||||The threshold for statistical significance was 0.05.|Mixed Models Analysis|Mixed model repeated measures analysis terms included baseline BMI, baseline age, gender, intervention group, visit, region, intervention group\*visit.||||||0.150
72412060|NCT00982020|144332200|SUPERIORITY_OR_OTHER|||||||0.52||||||The threshold for statistical significance was 0.05.|ANCOVA|ANCOVA model terms included: baseline, baseline age, gender, intervention group, and region.||||||0.520
72412061|NCT00982020|144332202|SUPERIORITY_OR_OTHER|||||||0.008||||||Threshold for statistical significance was 0.05|Mixed Models Analysis|MMRM analysis terms included baseline, intervention group, visit, region, and intervention group\*visit.||||||0.008
72412062|NCT00982020|144332203|SUPERIORITY_OR_OTHER|||||||0.266||||||The threshold for statistical significance was 0.05|Mixed Models Analysis|MMRM analysis terms included intervention group, visit, region, and intervention group\*visit.||||||0.266
72412063|NCT00982020|144332204|SUPERIORITY_OR_OTHER|||||||0.954||||||The threshold for statistical significance was 0.05.|Mixed Models Analysis|MMRM analysis terms included baseline, baseline age, gender, intervention group, visit, region, and intervention group\*visit.||||||0.954
72580632|NCT02414958|144691041|SUPERIORITY||Mean Difference (Final Values)|-1.3|STANDARD_ERROR_OF_MEAN|0.7||0.0457|TWO_SIDED|99.75|-2.7|0.0||Nominal p-value|MMRM||Mean Difference= Empagliflozin 10 milligram (mg) adjusted mean - Placebo matching Empagliflozin adjusted mean.|For DBP, the model MMRM includes baseline DBP seated, baseline eGFR baseline HbA1c as linear covariate and baseline pre-existing insulin therapy, treatment, visit, treatment by visit interaction, baseline DBP seated by visit interaction as fixed effect. An unstructured covariance structure was used to model the within-patient measurements.||0.0|-2.7|0.0457
72580633|NCT02414958|144691041|SUPERIORITY||Mean Difference (Final Values)|-2.3|STANDARD_ERROR_OF_MEAN|0.7||0.0006|TWO_SIDED|99.75|-4.3|-0.3|||MMRM||Mean Difference= Empagliflozin 25 milligram (mg) adjusted mean - Placebo matching Empagliflozin adjusted mean.|For DBP, the model MMRM includes baseline DBP seated, baseline estimated eGFR, baseline HbA1c as linear covariate and baseline pre-existing insulin therapy, treatment, visit, treatment by visit interaction, baseline DBP seated by visit interaction as fixed effect. An unstructured covariance structure was used to model the within-patient measurements.||-0.3|-4.3|0.0006
72580634|NCT05767905|144691043|OTHER||ratio|108.49|||||TWO_SIDED|90.0|100.55|117.05|||Mixed Models Analysis|"Mixed Model was fitted to obtain:~1.Ratio of geometric means 2.90% CI of ratio of geometric means"||Part 1 PF-06821497 Form 1 250 mg Fasted was the Reference treatment and Part 1 PF-06821497 Form 3 250 mg Fasted was the Test treatment.||117.05|100.55|
72580635|NCT05767905|144691043|OTHER||ratio|106.16|||||TWO_SIDED|90.0|98.39|114.54|||Mixed Models Analysis|Mixed Model was fitted to obtain:1.Ratio of geometric means 2.90% CI of ratio of geometric means||Part 1 PF-06821497 Form 3 250 mg Fasted was the Test treatment and Part 1 PF-06821497 Form 2 250 mg Fasted was the Reference treatment.||114.54|98.39|
72580636|NCT05767905|144691043|OTHER||ratio|228.99|||||TWO_SIDED|90.0|178.67|293.48|||Mixed Models Analysis|Mixed Model was fitted to obtain:1.Ratio of geometric means 2.90% CI of ratio of geometric means||Part 2 PF-06821497 Form 2 1250 mg Fed High-fat was the Test treatment and Part 2 PF-06821497 Form 2 1250 mg Fasted was the Reference treatment.||293.48|178.67|
72580637|NCT05767905|144691043|OTHER||ratio|207.19|||||TWO_SIDED|90.0|164.41|261.09||||||Part 2 PF-06821497 Form 2 1250 mg Fed Low-fat was the Test treatment and Part 2 PF-06821497 Form 2 1250 mg Fasted was the Reference treatment.||261.09|164.41|
72580638|NCT05767905|144691043|OTHER||ratio|102.19|||||TWO_SIDED|90.0|95.55|109.3|||Mixed Models Analysis|Mixed Model was fitted to obtain:1.Ratio of geometric means 2.90% CI of ratio of geometric means||Part 1 PF-06821497 Form 1 250 mg Fasted was the Reference treatment, and Part 1 PF-06821497 Form 2 250 mg Fasted was the Test treatment||109.30|95.55|
72580639|NCT05767905|144691044|OTHER||ratio|145.49|||||TWO_SIDED|90.0|121.29|174.53|||Mixed Models Analysis|Mixed Model was fitted to obtain:1.Ratio of geometric means 2.90% CI of ratio of geometric means||Part 1 PF-06821497 Form 3 250 mg Fasted was the Test treatment and Part 1 PF-06821497 Form 1 250 mg Fasted was the Reference treatment.||174.53|121.29|
72580640|NCT05767905|144691044|OTHER||ratio|122.64|||||TWO_SIDED|90.0|102.24|147.12|||Mixed Models Analysis|Mixed Model was fitted to obtain:1.Ratio of geometric means 2.90% CI of ratio of geometric means||Part 1 PF-06821497 Form 3 250 mg Fasted was the Test treatment and Part 1 PF-06821497 Form 2 250 mg Fasted was the Reference treatment.||147.12|102.24|
72580641|NCT05767905|144691044|OTHER||ratio|284.72|||||TWO_SIDED|90.0|226.39|358.06|||Mixed Models Analysis|Mixed Model was fitted to obtain:1.Ratio of geometric means 2.90% CI of ratio of geometric means||Part 2 PF-06821497 Form 2 1250 mg Fed Low-fat was the Test treatment and Part 2 PF-06821497 Form 2 1250 mg Fasted was the Reference treatment.||358.06|226.39|
72580642|NCT05767905|144691044|OTHER||ratio|327.87|||||TWO_SIDED|90.0|256.9|418.44|||Mixed Models Analysis|Mixed Model was fitted to obtain:1.Ratio of geometric means 2.90% CI of ratio of geometric means||Part 2 PF-06821497 Form 2 1250 mg Fed High-fat was the Test treatment and Part 2 PF-06821497 Form 2 1250 mg Fasted was the Reference treatment.||418.44|256.90|
72580643|NCT05767905|144691044|OTHER||ratio|118.63|||||TWO_SIDED|90.0|96.36|146.06|||Mixed Models Analysis|Mixed Model was fitted to obtain:1.Ratio of geometric means 2.90% CI of ratio of geometric means||Part 1 PF-06821497 Form 1 250 mg Fasted was the Reference treatment, and Part 1 PF-06821497 Form 2 250 mg Fasted was the Test treatment.||146.06|96.36|
72580644|NCT03762239|144691048|SUPERIORITY||Relative (percent) changes in the median|1.37||||0.52|TWO_SIDED|95.0|-2.81|5.56|||Conditional linear regression|Class group as strata. Adjusted for year of birth, sex as well as average temperature, relative humidity and CO2 concentration during the experiment.|Change comparing the filter group to the non-filter group|The hypothesis was that air filtration could result in better performance, relative to the classroom without air filter (normal air), in attention measures among adolescents in high schools.||5.56|-2.81|0.52
72580645|NCT03762239|144691049|SUPERIORITY||Beta coefficient|0.013||||0.72|TWO_SIDED|95.0|-0.0607|0.0865|||Regression, Linear|Using multiple imputation by chained equations. Adjusted for a rich set or relevant controls. Standard errors clustered at the high school level.|Change comparing the filter group to the non-filter group|The hypothesis was that air filtration could result in higher riskloving behavior, relative to the classroom without air filter (normal air), in the combined risk taking measures among adolescents in high schools.||0.0865|-0.0607|0.72
72546645|NCT00782509|144622631|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.053|STANDARD_ERROR_OF_MEAN|0.018||0.0043||95.0|0.017|0.089|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.089|0.017|0.0043
72546646|NCT00782509|144622631|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.065|STANDARD_ERROR_OF_MEAN|0.018||0.0005||95.0|0.028|0.101|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.101|0.028|0.0005
72546647|NCT00782509|144622632|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.073|STANDARD_ERROR_OF_MEAN|0.018|<|0.0001||95.0|0.037|0.11|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.110|0.037|<0.0001
72546648|NCT00782509|144622632|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.085|STANDARD_ERROR_OF_MEAN|0.018|<|0.0001||95.0|0.049|0.121|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.121|0.049|<0.0001
72546649|NCT00782509|144622633|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.069|STANDARD_ERROR_OF_MEAN|0.019||0.0002||95.0|0.032|0.106|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.106|0.032|0.0002
72546650|NCT00782509|144622633|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.044|STANDARD_ERROR_OF_MEAN|0.019||0.0186||95.0|0.007|0.081|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.081|0.007|0.0186
72546651|NCT00782509|144622634|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.069|STANDARD_ERROR_OF_MEAN|0.019||0.0003||95.0|0.032|0.106|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.106|0.032|0.0003
72546652|NCT00782509|144622634|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.058|STANDARD_ERROR_OF_MEAN|0.019||0.002||95.0|0.021|0.095|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.095|0.021|0.0020
72546653|NCT00782509|144622635|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.058|STANDARD_ERROR_OF_MEAN|0.019||0.0024||95.0|0.02|0.095|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.095|0.020|0.0024
72546654|NCT00782509|144622635|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.027|STANDARD_ERROR_OF_MEAN|0.019||0.1614||95.0|-0.011|0.064|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.064|-0.011|0.1614
72546655|NCT00782509|144622636|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.062|STANDARD_ERROR_OF_MEAN|0.019||0.0012||95.0|0.025|0.099|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.099|0.025|0.0012
72546656|NCT00782509|144622636|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.072|STANDARD_ERROR_OF_MEAN|0.019||0.0002||95.0|0.034|0.109|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.109|0.034|0.0002
72546657|NCT00782509|144622637|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.068|STANDARD_ERROR_OF_MEAN|0.019||0.0004||95.0|0.031|0.106|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.106|0.031|0.0004
72546658|NCT00782509|144622637|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.071|STANDARD_ERROR_OF_MEAN|0.019||0.0002||95.0|0.033|0.108|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.108|0.033|0.0002
72580646|NCT03762239|144691050|SUPERIORITY||Beta coefficient|-0.029||||0.5|TWO_SIDED|95.0|-0.117|0.0584|||Regression, Linear|Using multiple imputation by chained equations. Adjusted for a rich set or relevant controls. Standard errors clustered at the high school level|Change comparing the filter group to the non-filter group|The hypothesis was that air filtration could result in higher level of patience, relative to the classroom without air filter (normal air), in the combined patience measures among adolescents in high schools.||0.0584|-0.1170|0.50
72580647|NCT03762239|144691051|SUPERIORITY||Beta coefficient|0.06||||0.13|TWO_SIDED|95.0|-0.0184|0.1394|||Regression, Linear|Using multiple imputation by chained equations. Adjusted for a rich set or relevant controls. Standard errors clustered at the high school level.|Change comparing the filter group to the non-filter group|The hypothesis was that air filtration could result in higher level of positive reciprocity behavior, relative to the classroom without air filter (normal air), in the positive reciprocity measures among adolescents in high schools||0.1394|-0.0184|0.13
72546659|NCT00782509|144622638|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.168|STANDARD_ERROR_OF_MEAN|0.018|<|0.0001||95.0|0.132|0.203|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.203|0.132|<0.0001
72546660|NCT00782509|144622638|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.177|STANDARD_ERROR_OF_MEAN|0.018|<|0.0001||95.0|0.142|0.212|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.212|0.142|<0.0001
72546661|NCT00782509|144622639|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.155|STANDARD_ERROR_OF_MEAN|0.018|<|0.0001||95.0|0.119|0.19|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.190|0.119|<0.0001
72546662|NCT00782509|144622639|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.147|STANDARD_ERROR_OF_MEAN|0.018|<|0.0001||95.0|0.111|0.182|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.182|0.111|<0.0001
72546663|NCT00782509|144622640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.172|STANDARD_ERROR_OF_MEAN|0.018|<|0.0001||95.0|0.136|0.209|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.209|0.136|<0.0001
72546664|NCT00782509|144622640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.166|STANDARD_ERROR_OF_MEAN|0.018|<|0.0001||95.0|0.13|0.202|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.202|0.130|<0.0001
72546665|NCT00782509|144622641|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.144|STANDARD_ERROR_OF_MEAN|0.018|<|0.0001||95.0|0.108|0.18|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.180|0.108|<0.0001
72546666|NCT00782509|144622641|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.13|STANDARD_ERROR_OF_MEAN|0.018|<|0.0001||95.0|0.094|0.166|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.166|0.094|<0.0001
72546667|NCT00782509|144622642|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.164|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.128|0.201|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.201|0.128|<0.0001
72546668|NCT00782509|144622642|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.135|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.098|0.171|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.171|0.098|<0.0001
72546669|NCT00782509|144622643|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.155|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.118|0.192|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.192|0.118|<0.0001
72546670|NCT00782509|144622643|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.157|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.12|0.194|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.194|0.120|<0.0001
72546671|NCT00782509|144622644|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.331|STANDARD_ERROR_OF_MEAN|0.035|<|0.0001||95.0|0.263|0.399|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.399|0.263|<0.0001
72546672|NCT00782509|144622644|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.333|STANDARD_ERROR_OF_MEAN|0.034|<|0.0001||95.0|0.265|0.4|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.400|0.265|<0.0001
72546673|NCT00782509|144622645|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.242|STANDARD_ERROR_OF_MEAN|0.035|<|0.0001||95.0|0.174|0.31|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.310|0.174|<0.0001
72546674|NCT00782509|144622645|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.226|STANDARD_ERROR_OF_MEAN|0.035|<|0.0001||95.0|0.159|0.294|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.294|0.159|<0.0001
72546675|NCT00782509|144622646|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.263|STANDARD_ERROR_OF_MEAN|0.035|<|0.0001||95.0|0.195|0.332|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.332|0.195|<0.0001
72546676|NCT00782509|144622646|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.246|STANDARD_ERROR_OF_MEAN|0.035|<|0.0001||95.0|0.178|0.315|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.315|0.178|<0.0001
72546677|NCT00782509|144622647|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.239|STANDARD_ERROR_OF_MEAN|0.035|<|0.0001||95.0|0.17|0.308|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.308|0.170|<0.0001
72546678|NCT00782509|144622647|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.245|STANDARD_ERROR_OF_MEAN|0.035|<|0.0001||95.0|0.176|0.314|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.314|0.176|<0.0001
72412064|NCT00982020|144332205|SUPERIORITY_OR_OTHER|||||||0.103||||||Threshold for statistical significance was 0.05|Mixed Models Analysis|MMRM analysis terms included baseline, intervention group, visit, region, and intervention group\*visit.||||||0.103
72546679|NCT00782509|144622648|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.241|STANDARD_ERROR_OF_MEAN|0.036|<|0.0001||95.0|0.171|0.311|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.311|0.171|<0.0001
72546680|NCT00782509|144622648|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.219|STANDARD_ERROR_OF_MEAN|0.035|<|0.0001||95.0|0.15|0.289|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.289|0.150|<0.0001
72546681|NCT00782509|144622649|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.217|STANDARD_ERROR_OF_MEAN|0.036|<|0.0001||95.0|0.147|0.288|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.288|0.147|<0.0001
72412065|NCT00982020|144332206|SUPERIORITY_OR_OTHER|||||||0.436||||||The threshold for statistical significance was 0.05|Mixed Models Analysis|MMRM analysis terms included baseline, intervention group, visit, region, and intervention group\*visit.||||||0.436
72546682|NCT00782509|144622649|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.218|STANDARD_ERROR_OF_MEAN|0.036|<|0.0001||95.0|0.148|0.288|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.288|0.148|<0.0001
72546683|NCT00782509|144622650|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.059|STANDARD_ERROR_OF_MEAN|0.037||0.104||95.0|-0.012|0.131|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.131|-0.012|0.1040
72546684|NCT00782509|144622650|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.087|STANDARD_ERROR_OF_MEAN|0.036||0.0172||95.0|0.015|0.158|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.158|0.015|0.0172
72546685|NCT00782509|144622651|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.094|STANDARD_ERROR_OF_MEAN|0.037||0.0106||95.0|0.022|0.166|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.166|0.022|0.0106
72580648|NCT03762239|144691052|SUPERIORITY||Beta coefficient|0.022||||0.58|TWO_SIDED|95.0|-0.0595|0.1035|||Regression, Linear|Using multiple imputation by chained equations. Adjusted for a rich set or relevant controls. Standard errors clustered at the high school level.|Change comparing the filter group to the non-filter group|The hypothesis was that air filtration could result in higher Altruism behavior, relative to the classroom without air filter (normal air), in the Altruism measures among adolescents in high schools.||0.1035|-0.0595|0.58
72580649|NCT03762239|144691053|SUPERIORITY||Beta coefficient|0.013||||0.89|TWO_SIDED|95.0|-0.1786|0.2049|||Ordered logistic regression|Using multiple imputation by chained equations. Adjusted for a rich set or relevant controls. Standard errors clustered at the high school level.|Change comparing the filter group to the non-filter group|The hypothesis was that air filtration could result in higher trust, relative to the classroom without air filter (normal air), in the subjective trust measure among adolescents in high schools.||0.2049|-0.1786|0.89
72580650|NCT03762239|144691054|SUPERIORITY||Mean Difference (Final Values)|-0.13||||0.5|TWO_SIDED|95.0|-0.49|0.24|||Conditional linear regression|Class group as strata. Adjusted for year of birth, sex as well as average temperature, relative humidity and CO2 concentration during the experiment.|Change comparing the filter group to the non-filter group|||0.24|-0.49|0.50
72580651|NCT03762239|144691055|SUPERIORITY||Mean Difference (Final Values)|-0.05||||0.47|TWO_SIDED|95.0|-0.2|0.1|||Conditional linear regression|Class group as strata. Adjusted for year of birth, sex as well as average temperature, relative humidity and CO2 concentration during the experiment.|Change comparing the filter group to the non-filter group|||0.10|-0.20|0.47
72580652|NCT03762239|144691056|SUPERIORITY||Mean Difference (Final Values)|-3.38||||0.2|TWO_SIDED|95.0|-8.51|1.74|||Conditional linear regression|Class group as strata. Adjusted for year of birth, sex as well as average temperature, relative humidity and CO2 concentration during the experiment.||||1.74|-8.51|0.20
72580653|NCT03762239|144691057|SUPERIORITY||Mean Difference (Final Values)|-0.25||||0.92|TWO_SIDED|95.0|-5.1|4.6|||Conditional linear regression|Class group as strata. Adjusted for year of birth, sex as well as average temperature, relative humidity and CO2 concentration during the experiment.||||4.60|-5.10|0.92
72580654|NCT03762239|144691058|SUPERIORITY||Mean Difference (Final Values)|-1.36||||0.46|TWO_SIDED|95.0|-4.94|2.22|||Conditional linear regression|Class group as strata. Adjusted for year of birth, sex as well as average temperature, relative humidity and CO2 concentration during the experiment.||||2.22|-4.94|0.46
72580655|NCT03762239|144691059|SUPERIORITY||Beta coefficient|-0.1446||||0.232|TWO_SIDED|95.0|-0.382|0.0928|||Ordered logistic regression|Adjusted for a rich set or relevant controls. Standard errors clustered at the high school level.|Change comparing the filter group to the non-filter group|The hypothesis was that air filtration could result in higher assessment of math skills, relative to the classroom without air filter (normal air), in the self assessed math skills measure among adolescents in high schools.||0.0928|-0.3820|0.232
72580656|NCT04660331|144691083|OTHER||||||||||||||||||2-sided t-test conducted for pre- and post-training results.|||
72580657|NCT04660331|144691084|OTHER||||||||||||||||||We grouped pharmacy data on vaccines delivered pre/post intervention into six categories: HPV vaccine, Tdap, Meningococcal, Influenza, COVID-19, and other vaccines. We then compared the counts of total vaccines that were conducted in each group pre- and post-training.|||
72580658|NCT04660331|144691085|OTHER||||||||||||||||||We grouped pharmacy data on vaccines delivered pre/post intervention into six categories: HPV vaccine, Tdap, Meningococcal, Influenza, COVID-19, and other vaccines. We then compared the counts of total vaccines that were conducted in each group pre- and post-training.|||
72580659|NCT02635984|144691094|SUPERIORITY|||||||0.003|||||||Chi-squared|||Based on an 80 % power and an alpha of 0.05, we estimated a need for 49 patients in each treatment arm. From a review of existing literature, the sample size was based on an estimated CR achieved in 65 % of patients on triplet therapy alone and a hypothesized clinically relevant increase of 25 % for the treatment group to 90 %.||||0.003
72580660|NCT02635984|144691095|SUPERIORITY|||||||0.001|||||||Chi-squared|||||||0.001
72546686|NCT00782509|144622651|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.118|STANDARD_ERROR_OF_MEAN|0.037||0.0013||95.0|0.046|0.19|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.190|0.046|0.0013
72580661|NCT02635984|144691096|SUPERIORITY|||||||0.11|||||||Chi-squared|||||||0.11
72580662|NCT02635984|144691097|SUPERIORITY|||||||0.28|||||||Chi-squared|||||||0.28
72580663|NCT02635984|144691098|SUPERIORITY|||||||0.002|||||||Chi-squared|||||||0.002
72580664|NCT02635984|144691099|SUPERIORITY|||||||0.006|||||||Chi-squared|||||||0.006
72580665|NCT02635984|144691100|SUPERIORITY|||||||0.13|||||||Chi-squared|||||||0.13
72580666|NCT02635984|144691101|SUPERIORITY|||||||0.001|||||||Chi-squared|||||||0.001
72546687|NCT00782509|144622652|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.032|STANDARD_ERROR_OF_MEAN|0.037||0.3821||95.0|-0.04|0.105|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.105|-0.040|0.3821
72546688|NCT00782509|144622652|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.048|STANDARD_ERROR_OF_MEAN|0.037||0.1917||95.0|-0.024|0.12|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.120|-0.024|0.1917
72546689|NCT00782509|144622653|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.037||0.1808||95.0|-0.023|0.123|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.123|-0.023|0.1808
72580667|NCT01776632|144691107|SUPERIORITY||difference of adjusted means|0.15||||0.03|TWO_SIDED||||||generalized linear mixed effects|||||||.03
72580668|NCT01776632|144691108|SUPERIORITY||difference of adjusted means|0.39||||0.003|TWO_SIDED||||||generalized linear mixed effects|||||||.003
72580669|NCT01776632|144691109|SUPERIORITY||difference of adjusted means|-0.43||||0.04|TWO_SIDED||||||mixed effects models|||||||.04
72546690|NCT00782509|144622653|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.033|STANDARD_ERROR_OF_MEAN|0.037||0.37||95.0|-0.039|0.106|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.106|-0.039|0.3700
72546691|NCT00782509|144622654|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.045|STANDARD_ERROR_OF_MEAN|0.037||0.2312||95.0|-0.029|0.118|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.118|-0.029|0.2312
72580670|NCT01776632|144691110|SUPERIORITY||difference of adjusted means|-1.27||||0.09|TWO_SIDED||||||mixed effects models|||||||.09
72580671|NCT00708110|144691115|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.54|||<|0.001|TWO_SIDED|95.0|-2.0|-1.07|||ANCOVA|||||-1.07|-2.00|<0.001
72580672|NCT00708110|144691115|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.04|||<|0.001|TWO_SIDED|95.0|-2.52|-1.55|||ANCOVA|||||-1.55|-2.52|<0.001
72580673|NCT00708110|144691115|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.48|||<|0.001|TWO_SIDED|95.0|-2.94|-2.02|||ANCOVA|||||-2.02|-2.94|<0.001
72580674|NCT02289729|144691140|SUPERIORITY||||||<|0.0001|||||||t-test|||||||< 0.0001
72580675|NCT02289729|144691141|SUPERIORITY||||||<|0.0001|||||||t-test|||||||< 0.0001
72580676|NCT02289729|144691142|SUPERIORITY||||||<|0.0001|||||||t-test|||||||< 0.0001
72580677|NCT02289729|144691143|SUPERIORITY||||||<|0.0001|||||||t-test|||||||< 0.0001
72580678|NCT02289729|144691144|SUPERIORITY|||||||0.0328|||||||t-test|||||||0.0328
72580679|NCT02289729|144691145|SUPERIORITY|||||||0.4183|||||||t-test|||||||0.4183
72580680|NCT02289729|144691146|SUPERIORITY||||||<|0.0001|||||||t-test|||||||< 0.0001
72580681|NCT02289729|144691147|SUPERIORITY|||||||0.0003|||||||t-test|||||||0.0003
72580682|NCT02289729|144691148|SUPERIORITY|||||||0.0109|||||||t-test|||||||0.0109
72546692|NCT00782509|144622654|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.07|STANDARD_ERROR_OF_MEAN|0.037||0.0596||95.0|-0.003|0.144|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.144|-0.003|0.0596
72546693|NCT00782509|144622655|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.038|STANDARD_ERROR_OF_MEAN|0.037||0.311||95.0|-0.036|0.111|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.111|-0.036|0.3110
72546694|NCT00782509|144622655|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.003|STANDARD_ERROR_OF_MEAN|0.038||0.9426||95.0|-0.076|0.071|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.071|-0.076|0.9426
72580683|NCT02289729|144691149|SUPERIORITY|||||||0.0002|||||||t-test|||||||0.0002
72580684|NCT02289729|144691150|SUPERIORITY||||||<|0.0001|||||||t-test|||||||< 0.0001
72580685|NCT02289729|144691151|SUPERIORITY|||||||0.0002|||||||signed-rank test|||||||0.0002
72580686|NCT02289729|144691152|SUPERIORITY||||||<|0.0001|||||||t-test|||||||< 0.0001
72580687|NCT02289729|144691153|SUPERIORITY|||||||0.0038|||||||t-test|||||||0.0038
72580688|NCT02289729|144691154|SUPERIORITY||||||<|0.0001|||||||signed-rank test|||||||< 0.0001
72580689|NCT02289729|144691155|SUPERIORITY|||||||0.0274|||||||signed-rank test|||||||0.0274
72580690|NCT02289729|144691156|SUPERIORITY||||||<|0.0001|||||||signed-rank test|||||||< 0.0001
72580691|NCT02289729|144691157|SUPERIORITY|||||||0.0006|||||||t-test|||||||0.0006
72580692|NCT02289729|144691158|SUPERIORITY|||||||0.001|||||||signed-rank test|||||||0.0010
72580693|NCT02289729|144691159|SUPERIORITY|||||||0.0002|||||||t-test|||||||0.0002
72580694|NCT02289729|144691160|SUPERIORITY|||||||0.0297|||||||t-test|||||||0.0297
72580695|NCT02289729|144691161|SUPERIORITY|||||||0.0279|||||||t-test|||||||0.0279
72580696|NCT02289729|144691162|SUPERIORITY|||||||0.2777|||||||t-test|||||||0.2777
72580697|NCT02289729|144691163|SUPERIORITY|||||||0.0047|||||||t-test|||||||0.0047
72580698|NCT02289729|144691164|SUPERIORITY|||||||0.0003|||||||t-test|||||||0.0003
72580699|NCT02289729|144691165|SUPERIORITY||||||<|0.5877|||||||t-test|||||||<0.5877
72580700|NCT02289729|144691166|SUPERIORITY|||||||0.0002|||||||t-test|||||||0.0002
72580701|NCT02289729|144691167|SUPERIORITY||||||<|0.0001|||||||t-test|||||||<0.0001
72580702|NCT02289729|144691168|SUPERIORITY||||||<|0.0001|||||||t-test|||||||< 0.0001
72580703|NCT02289729|144691169|SUPERIORITY||||||<|0.0001|||||||signed-rank test|||||||< 0.0001
72580704|NCT02289729|144691170|SUPERIORITY||||||<|0.0001|||||||t-test|||||||< 0.0001
72580705|NCT02289729|144691171|SUPERIORITY|||||||0.0001|||||||t-test|||||||0.0001
72580706|NCT02289729|144691172|SUPERIORITY||||||<|0.0001|||||||signed-rank test|||||||< 0.0001
72580707|NCT02289729|144691173|SUPERIORITY|||||||0.2428|||||||signed-rank test|||||||0.2428
72580708|NCT02289729|144691174|SUPERIORITY|||||||0.0687|||||||t-test|||||||0.0687
72580709|NCT02289729|144691175|SUPERIORITY|||||||0.3126|||||||t-test|||||||0.3126
72412066|NCT01854554|144332207|SUPERIORITY|||||||0.74|||||||Gray's test|Cumulative Incidence Function treating progressive disease (RANO) or death before cognitive function decline as a competing risk.||||||.74
72412067|NCT01854554|144332208|SUPERIORITY|||||||0.6|||||||Log Rank|||||||.60
72412068|NCT01854554|144332209|SUPERIORITY|||||||0.24|||||||Log Rank|||||||0.24
72412069|NCT02819726|144332211|EQUIVALENCE|Standard acceptance limits for bioequivalence (80.00% to 125.00%) for all treatment comparisons|GLS Mean Ration|95.33|||||TWO_SIDED|90.0|87.07|104.37||||||The statistical comparison of the loge-transformed primary parameters between treatments is based on an analysis of variance model (ANOVA) with fixed effect for treatment||104.37|87.07|
72412070|NCT02819726|144332211|EQUIVALENCE|Standard acceptance limits for bioequivalence (80.00% to 125.00%) for all treatment comparisons|GLS Mean Ratio|93.43|||||TWO_SIDED|90.0|85.54|102.15||||||The statistical comparison of the loge-transformed primary parameters between treatments is based on an analysis of variance (ANOVA) model with fixed effect for treatment||102.15|85.54|
72412071|NCT02819726|144332211|EQUIVALENCE|Standard acceptance limits for bioequivalence (80.00% to 125.00%) for all treatment comparisons|GLS Mean Ratio|98.06|||||TWO_SIDED|90.0|89.49|107.45||||||The statistical comparison of the loge-transformed primary parameters between treatments is based on an analysis of variance model (ANOVA) with fixed effect for treatment||107.45|89.49|
72412072|NCT02819726|144332212|EQUIVALENCE|Standard acceptance limits for bioequivalence (80.00% to 125.00%) for all treatment comparisons|GLS Mean Ratio|94.07|||||TWO_SIDED|90.0|86.91|101.81||||||The statistical comparison of the loge-transformed primary parameters between treatments is based on an analysis of variance (ANOVA) model with fixed effect for treatment||101.81|86.91|
72412073|NCT02819726|144332212|EQUIVALENCE|Standard acceptance limits for bioequivalence (80.00% to 125.00%) for all treatment comparisons|GLS Mean Ration|94.39|||||TWO_SIDED|90.0|87.21|102.16||||||The statistical comparison of the loge-transformed primary parameters between treatments is based on an analysis of variance (ANOVA) model with fixed effect for treatment||102.16|87.21|
72412074|NCT02819726|144332212|EQUIVALENCE|Standard acceptance limits for bioequivalence (80.00% to 125.00%) for all treatment comparisons|GLS Mean Ratio|100.35|||||TWO_SIDED|90.0|92.68|108.65||||||The statistical comparison of the loge-transformed primary parameters between treatments is based on an analysis of variance (ANOVA) model with fixed effect for treatment||108.65|92.68|
72546695|NCT00782509|144622656|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.042|STANDARD_ERROR_OF_MEAN|0.038||0.268||95.0|-0.032|0.115|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.115|-0.032|0.2680
72546696|NCT00782509|144622656|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.069|STANDARD_ERROR_OF_MEAN|0.038||0.0662||95.0|-0.005|0.143|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.143|-0.005|0.0662
72580710|NCT02289729|144691176|SUPERIORITY|||||||0.1533|||||||t-test|||||||0.1533
72580711|NCT02289729|144691177|SUPERIORITY|||||||0.8145|||||||t-test|||||||0.8145
72580712|NCT02289729|144691178|SUPERIORITY|||||||0.4048|||||||t-test|||||||0.4048
72580713|NCT02289729|144691179|SUPERIORITY|||||||0.8321|||||||t-test|||||||0.8321
72412075|NCT02819726|144332213|EQUIVALENCE|Standard acceptance limits for bioequivalence (80.00% to 125.00%) for all treatment comparisons|GLS Mean Ratio|96.31|||||TWO_SIDED|90.0|90.52|102.46||||||The statistical comparison of the loge-transformed primary parameters between treatments is based on an analysis of variance (ANOVA) model with fixed effect for treatment||102.46|90.52|
72412076|NCT02819726|144332213|EQUIVALENCE|Standard acceptance limits for bioequivalence (80.00% to 125.00%) for all treatment comparisons|GLS Mean Ratio|98.65|||||TWO_SIDED|90.0|92.64|105.05||||||The statistical comparison of the loge-transformed primary parameters between treatments is based on an analysis of variance (ANOVA) model with fixed effect for treatment||105.05|92.64|
72412077|NCT02819726|144332213|EQUIVALENCE|Standard acceptance limits for bioequivalence (80.00% to 125.00%) for all treatment comparisons|GLS Mean Ratio|102.43|||||TWO_SIDED|90.0|96.14|109.14||||||The statistical comparison of the loge-transformed primary parameters between treatments is based on an analysis of variance (ANOVA) model with fixed effect for treatment||109.14|96.14|
72546697|NCT00782509|144622657|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.046|STANDARD_ERROR_OF_MEAN|0.038||0.2249||95.0|-0.028|0.12|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.120|-0.028|0.2249
72580714|NCT02289729|144691180|SUPERIORITY|||||||0.1945|||||||signed-rank test|||||||0.1945
72580715|NCT02289729|144691181|SUPERIORITY|||||||0.7937|||||||t-test|||||||0.7937
72580716|NCT02289729|144691182|SUPERIORITY|||||||0.0234|||||||signed-rank test|||||||0.0234
72580717|NCT02289729|144691183|SUPERIORITY|||||||0.5922|||||||t-test|||||||0.5922
72412078|NCT02819726|144332214|EQUIVALENCE|Standard acceptance limits for bioequivalence (80.00% to 125.00%) for all treatment comparisons|GLS Mean Ratio|94.93|||||TWO_SIDED|90.0|89.03|101.23||||||The statistical comparison of the loge-transformed primary parameters between treatments is based on an analysis of variance (ANOVA) model with fixed effect for treatment||101.23|89.03|
72412079|NCT02819726|144332214|EQUIVALENCE|Standard acceptance limits for bioequivalence (80.00% to 125.00%) for all treatment comparisons|GLS Mean Ratio|98.75|||||TWO_SIDED|90.0|92.61|105.3||||||The statistical comparison of the loge-transformed primary parameters between treatments is based on an analysis of variance (ANOVA) model with fixed effect for treatment||105.30|92.61|
72580718|NCT02289729|144691184|SUPERIORITY|||||||1|||||||t-test|||||||1.000
72580719|NCT02289729|144691185|SUPERIORITY|||||||0.6481|||||||t-test|||||||0.6481
72580720|NCT02289729|144691186|SUPERIORITY|||||||0.6741|||||||t-test|||||||0.6741
72580721|NCT02289729|144691187|OTHER||Fisher's z|0.27846||||0.0389|TWO_SIDED|95.0|0.014175|0.495059|||Fisher's z Transformation|||PDQ-39 with UPDRS-III||0.495059|0.014175|0.0389
72580722|NCT02289729|144691187|OTHER||Fisher's z|0.07359||||0.5852|TWO_SIDED|95.0|-0.188409|0.32558|||Fisher's z Transformation|||PDQ-39 with UPDRS-IV||0.325580|-0.188409|0.5852
72580723|NCT02289729|144691187|OTHER||Fisher's z|0.21311||||0.114|TWO_SIDED|95.0|-0.051127|0.444152|||Fisher's z Transformation|||PDQ-39 with NMSS||0.444152|-0.051127|0.1140
72580724|NCT02289729|144691187|OTHER||Fisher's z|0.29062||||0.0311|TWO_SIDED|95.0|0.026334|0.504186|||Fisher's z Transformation|||PDQ-39 with BAI||0.504186|0.026334|0.0311
72580725|NCT02289729|144691187|OTHER||Fisher's z|0.49952||||0.0002|TWO_SIDED|95.0|0.230995|0.643312|||Fisher's z Transformation|||PDQ-39 with BDI-II||0.643312|0.230995|0.0002
72580726|NCT02289729|144691187|OTHER||Fisher's z|0.08869||||0.5146|TWO_SIDED|95.0|-0.176169|0.341163|||Fisher's z Transformation|||PDQ-39 with AS||0.341163|-0.176169|0.5146
72580727|NCT02289729|144691187|OTHER||Fisher's z|0.34688||||0.0108|TWO_SIDED|95.0|0.079996|0.546657|||Fisher's z Transformation|||PDQ-39 with PFS||0.546657|0.079996|0.0108
72580728|NCT02289729|144691187|OTHER||Fisher's z|0.22455||||0.0989|TWO_SIDED|95.0|-0.042139|0.455224|||Fisher's z Transformation|||PDQ-39 with NBL A-S||0.455224|-0.042139|0.0989
72580729|NCT02289729|144691187|OTHER||Fisher's z|0.35742||||0.006|TWO_SIDED|95.0|0.106797|0.565335|||Fisher's z Transformation|||PDQ-39 with NBL C-D||0.565335|0.106797|0.0060
72580730|NCT02289729|144691187|OTHER||Fisher's z|0.00011||||0.9993|TWO_SIDED|95.0|-0.260462|0.260673|||Fisher's z Transformation|||PDQ-39 with NBL C-R||0.260673|-0.260462|0.9993
72580731|NCT02289729|144691187|OTHER||Fisher's z|-0.36687||||0.0088|TWO_SIDED|95.0|-0.565795|-0.092154|||Fisher's z Transformation|||PDQ-39 with ZBI||-0.092154|-0.565795|0.0088
72580732|NCT02289729|144691187|OTHER||Fisher's z|0.21643||||0.1222|TWO_SIDED|95.0|-0.057959|0.454911|||Fisher's z Transformation|||PDQ-39 with Goldberg-Anxiety||0.454911|-0.057959|0.1222
72580733|NCT02289729|144691187|OTHER||Fisher's z|0.57423||||0.0041|TWO_SIDED|95.0|0.180247|0.74704|||Fisher's z Transformation|||PDQ-39 with Goldberg-Depression||0.747040|0.180247|0.0041
72580734|NCT02289729|144691188|OTHER||Fisher's z|0.31946||||0.0239|TWO_SIDED|95.0|0.042257|0.534657|||Fisher's z Transformation|||PDQ-39 with UPDRS-III||0.534657|0.042257|0.0239
72580735|NCT02289729|144691188|OTHER||Fisher's z|0.36796||||0.0093|TWO_SIDED|95.0|0.090528|0.568388|||Fisher's z Transformation|||PDQ-39 with UPDRS-IV||0.568388|0.090528|0.0093
72580736|NCT02289729|144691188|OTHER||Fisher's z|0.38627||||0.0069|TWO_SIDED|95.0|0.105875|0.582517|||Fisher's z Transformation|||PDQ-39 with NMSS||0.582517|0.105875|0.0069
72580737|NCT02289729|144691188|OTHER||Fisher's z|0.70289|||<|0.0001|TWO_SIDED|95.0|0.40173|0.753097|||Fisher's z Transformation|||PDQ-39 with BAI||0.753097|0.401730|< 0.0001
72580738|NCT02289729|144691188|OTHER||Fisher's z|0.63758|||<|0.0001|TWO_SIDED|95.0|0.345567|0.72341|||Fisher's z Transformation|||PDQ-39 with BDI-II||0.723410|0.345567|<0.0001
72580739|NCT02289729|144691188|OTHER||Fisher's z|0.24114||||0.0882|TWO_SIDED|95.0|-0.036024|0.476404|||Fisher's z Transformation|||PDQ-39 with AS||0.476404|-0.036024|0.0882
72580740|NCT02289729|144691188|OTHER||Fisher's z|0.67113|||<|0.0001|TWO_SIDED|95.0|0.374757|0.739016|||Fisher's z Transformation|||PDQ-39 with PFS||0.739016|0.374757|< 0.0001
72580741|NCT02289729|144691188|OTHER||Fisher's z|0.60612|||<|0.0001|TWO_SIDED|95.0|0.317572|0.708072|||Fisher's z Transformation|||PDQ-39 with NBL A-S||0.708072|0.317572|< 0.0001
72580742|NCT02289729|144691188|OTHER||Fisher's z|0.60613|||<|0.0001|TWO_SIDED|95.0|0.31758|0.708076|||Fisher's z Transformation|||PDQ-39 with NBL C-D||0.708076|0.317580|< 0.0001
72580743|NCT02289729|144691188|OTHER||Fisher's z|0.41143||||0.0036|TWO_SIDED|95.0|0.133445|0.597087|||Fisher's z Transformation|||PDQ-39 with NBL C-R||0.597087|0.133445|0.0036
72580744|NCT02289729|144691188|OTHER||Fisher's z|-0.33661||||0.0239|TWO_SIDED|95.0|-0.557217|-0.044411|||Fisher's z Transformation|||PDQ-39 with ZBI||-0.044411|-0.557217|0.0239
72580745|NCT02289729|144691188|OTHER||Fisher's z|0.64565|||<|0.0001|TWO_SIDED|95.0|0.339454|0.734221|||Fisher's z Transformation|||PDQ-39 with Goldberg-Anxiety||0.734221|0.339454|< 0.0001
72580746|NCT02289729|144691188|OTHER||Fisher's z|0.10898||||0.7058|TWO_SIDED|95.0|-0.427482|0.588111|||Fisher's z Transformation|||PDQ-39 with Goldberg-Depression||0.588111|-0.427482|0.7058
72580747|NCT02289729|144691189|OTHER||Fisher's z|-0.57271|||<|0.0001|TWO_SIDED|95.0|-0.689585|-0.289724|||Fisher's z Transformation|||SQLC with ZBI||-0.289724|-0.689585|< 0.0001
72580748|NCT02289729|144691189|OTHER||Fisher's z|-0.16332||||0.4142|TWO_SIDED|95.0|-0.504489|0.224771|||Fisher's z Transformation|||SQLC with Goldberg Anxiety||0.224771|-0.504489|0.4142
72580749|NCT02289729|144691189|OTHER||Fisher's z|-0.48143||||0.0239|TWO_SIDED|95.0|-0.715956|-0.063481|||Fisher's z Transformation|||SQLC with Goldberg Depression||-0.063481|-0.715956|0.0239
72580750|NCT02289729|144691189|OTHER||Fisher's z|0.06326||||0.6546|TWO_SIDED|95.0|-0.210715|0.327872|||Fisher's z Transformation|||SQLC with NBL A-S||0.327872|-0.210715|0.6546
72580751|NCT02289729|144691189|OTHER||Fisher's z|0.17674||||0.2114|TWO_SIDED|95.0|-0.100105|0.425116|||Fisher's z Transformation|||SQLC with NBL C-D||0.425116|-0.100105|0.2114
72580752|NCT02289729|144691189|OTHER||Fisher's z|0.2944||||0.0374|TWO_SIDED|95.0|0.017222|0.516523|||Fisher's z Transformation|||SQLC with NBL C-R||0.516523|0.017222|0.0374
72580753|NCT02289729|144691189|OTHER||Fisher's z|-0.36687||||0.0088|TWO_SIDED|95.0|-0.565795|-0.092154|||Fisher's z Transformation|||SQLC with Global PDQ-39||-0.092154|-0.565795|0.0088
72580754|NCT02289729|144691189|OTHER||Fisher's z|-0.13433||||0.3374|TWO_SIDED|95.0|-0.387439|0.139207|||Fisher's z Transformation|||SQLC with UPDRS-III||0.139207|-0.387439|0.3374
72580755|NCT02289729|144691189|OTHER||Fisher's z|0.17846||||0.2025|TWO_SIDED|95.0|-0.095693|0.424291|||Fisher's z Transformation|||SQLC with UPDRS-IV||0.424291|-0.095693|0.2025
72580756|NCT02289729|144691189|OTHER||Fisher's z|0.01625||||0.9076|TWO_SIDED|95.0|-0.252613|0.282777|||Fisher's z Transformation|||SQLC with Global NMSS||0.282777|-0.252613|0.9076
72580757|NCT02289729|144691190|OTHER||Fisher's z|-0.7468|||<|0.0001|TWO_SIDED|95.0|-0.777482|-0.425693|||Fisher's z Transformation|||SQLC with ZBI||-0.425693|-0.777482|< 0.0001
72580758|NCT02289729|144691190|OTHER||Fisher's z|0.17924||||0.5347|TWO_SIDED|95.0|-0.368382|0.632178|||Fisher's z Transformation|||SQLC with Goldberg Anxiety||0.632178|-0.368382|0.5347
72580759|NCT02289729|144691190|OTHER||Fisher's z|-0.06987||||0.8251|TWO_SIDED|95.0|-0.597767|0.500464|||Fisher's z Transformation|||SQLC with Goldberg Depression||0.500464|-0.597767|0.8251
72580760|NCT02289729|144691190|OTHER||Fisher's z|-0.1106||||0.4581|TWO_SIDED|95.0|-0.382323|0.179601|||Fisher's z transformation|||SQLC with NBL A-S||0.179601|-0.382323|0.4581
72580761|NCT02289729|144691190|OTHER||Fisher's z|0.00326||||0.9826|TWO_SIDED|95.0|-0.281136|0.287128|||Fisher's z Transformation|||SQLC with NBL C-D||0.287128|-0.281136|0.9826
72580762|NCT02289729|144691190|OTHER||Fisher's z|-0.10293||||0.4899|TWO_SIDED|95.0|-0.375749|0.187021|||Fisher's z Transformation|||SQLC with NBL C-R||0.187021|-0.375749|0.4899
72580763|NCT02289729|144691190|OTHER||Fisher's z|-0.33661||||0.0239|TWO_SIDED|95.0|-0.557217|-0.044411|||Fisher's z Transformation|||SQLC with Global PDQ-39||-0.044411|-0.557217|0.0239
72546698|NCT00782509|144622657|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.062|STANDARD_ERROR_OF_MEAN|0.038||0.0994||95.0|-0.012|0.136|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.136|-0.012|0.0994
72546699|NCT00782509|144622658|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.332|STANDARD_ERROR_OF_MEAN|0.036|<|0.0001||95.0|0.261|0.403|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.403|0.261|<0.0001
72546700|NCT00782509|144622658|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.333|STANDARD_ERROR_OF_MEAN|0.036|<|0.0001||95.0|0.263|0.403|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.403|0.263|<0.0001
72546701|NCT00782509|144622659|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.225|STANDARD_ERROR_OF_MEAN|0.036|<|0.0001||95.0|0.153|0.296|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.296|0.153|<0.0001
72546702|NCT00782509|144622659|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.21|STANDARD_ERROR_OF_MEAN|0.036|<|0.0001||95.0|0.139|0.281|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.281|0.139|<0.0001
72546703|NCT00782509|144622660|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.268|STANDARD_ERROR_OF_MEAN|0.037|<|0.0001||95.0|0.196|0.34|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.340|0.196|<0.0001
72546704|NCT00782509|144622660|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.251|STANDARD_ERROR_OF_MEAN|0.037|<|0.0001||95.0|0.179|0.323|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.323|0.179|<0.0001
72546705|NCT00782509|144622661|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.226|STANDARD_ERROR_OF_MEAN|0.037|<|0.0001||95.0|0.154|0.298|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.298|0.154|<0.0001
72546706|NCT00782509|144622661|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.209|STANDARD_ERROR_OF_MEAN|0.037|<|0.0001||95.0|0.137|0.281|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.281|0.137|<0.0001
72580764|NCT02289729|144691190|OTHER||Fisher's z|-0.23658||||0.1125|TWO_SIDED|95.0|-0.484427|0.055538|||Fisher's z Transformation|||SQLC with UPDRS-III||0.055538|-0.484427|0.1125
72546707|NCT00782509|144622662|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.226|STANDARD_ERROR_OF_MEAN|0.037|<|0.0001||95.0|0.153|0.299|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.299|0.153|<0.0001
72546708|NCT00782509|144622662|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.206|STANDARD_ERROR_OF_MEAN|0.037|<|0.0001||95.0|0.133|0.279|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.279|0.133|<0.0001
72580765|NCT02289729|144691190|OTHER||Fisher's z|-0.13015||||0.3826|TWO_SIDED|95.0|-0.398887|0.16062|||Fisher's z Transformation|||SQLC with UPDRS-IV||0.160620|-0.398887|0.3826
72580766|NCT02289729|144691190|OTHER||Fisher's z|0.11688||||0.4382|TWO_SIDED|95.0|-0.176724|0.390468|||Fisher's z Transformation|||SQLC with Global NMSS||0.390468|-0.176724|0.4382
72580767|NCT01875978|144691191|SUPERIORITY_OR_OTHER||||||<|0.05||||||P-value \<0.05 is significance meaningful.|t-test, 1 sided|Student's t-test, 1 sided||Hypothesis: phytosterols improve metabolic status||||<0.05
72580768|NCT01875978|144691192|SUPERIORITY_OR_OTHER||||||<|0.05||||||P value \<0.05 for statistical significance|t-test, 1 sided|Student's t test, 1 sided||Hypothesis: phytosterols increase the anti-oxidative capacity.||||<0.05
72580769|NCT01875978|144691193|SUPERIORITY_OR_OTHER||||||<|0.05||||||P\<0.05 for statistical significance|t-test, 1 sided|Student's t test, 1 sided||Phytosterols increase IGF-1||||<0.05
72580770|NCT01875978|144691194|SUPERIORITY_OR_OTHER||||||<|0.05||||||P value \<0.05 for statistical significance|t-test, 1 sided|Student's t-test, 1 sided||Hypothesis:phytosterols increase endothelial progenitor cells to provide endothelial repair and vessel protection||||<0.05
72580771|NCT04870710|144691202|SUPERIORITY||Median Difference (Net)|0.1||||0.1|TWO_SIDED||||||Friedman||||Non-parametric tests were used consisting of Friedman and Durbin Conover tests|||0.10
72580772|NCT03123068|144691225|OTHER||||||>|0.05|||||||Mann Whitney U test|||||||>0.05
72580773|NCT05724589|144691229|SUPERIORITY|A repeated measures ANOVA was selected to analyze changes in skin hydration across four time points within the same participants..|Mean Difference (Final Values)|2.671||||1|TWO_SIDED|||||The p-value reflects the overall test for difference in hydration over time and is not adjusted for multiple comparisons. The pre-defined threshold for statistical significance was p \< 0.05.|ANOVA|No additional adjustments were applied. Degrees of freedom and sphericity assumptions were checked.|The mean difference was calculated based on changes in skin hydration from baseline to Week 16 using repeated measures ANOVA, in accordance with the pre-specified statistical analysis plan.|Skin hydration was evaluated longitudinally using repeated measures ANOVA at Baseline, Week 8, Week 12, and Week 16. This pre-specified statistical test assessed within-subject changes over time to determine the efficacy of the serum.|The overall p-value corresponds to the repeated measures ANOVA evaluating changes over four time points. No multiplicity adjustments were applied.|||1.000
72580774|NCT05724589|144691230|SUPERIORITY|The statistical analysis in this study to assess changes in Transepidermal Water Loss (TEWL) after serum application involved a repeated measures analysis of variance (ANOVA). This approach allows for the examination of differences in TEWL across multiple time points (baseline, 8 weeks, 12 weeks, and 16 weeks) within the same individuals. The use of repeated measures ANOVA accounts for the correlated nature of the data, as multiple measurements are obtained from each participant over time.|Mean Difference (Final Values)|-3.656||||0.096|TWO_SIDED|||||A repeated measures ANOVA was used to assess changes in hydration over time. The mean difference between baseline and 16 weeks was -3.656 (arbitrary units). Results are presented in the corresponding outcome measure table.|ANOVA|||||||0.096
72580775|NCT05724589|144691231|SUPERIORITY|The chosen test was designed to assess whether application of the intervention resulted in any statistically significant differences over time in the primary outcome measure, assuming superiority.|Mean Difference (Final Values)|-0.043||||0.169|TWO_SIDED|||||The pre-specified significance threshold was set at p \< 0.05. No adjustments for multiple comparisons were applied.|ANOVA|Sphericity tested; Greenhouse-Geisser applied if needed. Repeated measures ANOVA accounted for within-subject correlations.|The estimation parameter reflects the change in the R2 elasticity measure from baseline to 16 weeks. The direction of change is based on the final minus baseline value, with baseline serving as the reference point.|The statistical analysis utilized repeated measures ANOVA to evaluate changes in facial skin elasticity (R2 parameter) across multiple time points (Baseline, Week 8, Week 12, and Week 16) within the same participants. This approach accounts for the correlation of repeated measures over time.||||0.169
72580776|NCT05724589|144691232|SUPERIORITY|This study aimed to evaluate changes in wrinkle scores using a 4-grade percentage wrinkle improvement scale across different time points, including baseline, 8 weeks, 12 weeks, and 16 weeks|Mean Difference (Final Values)|1.0||||1|TWO_SIDED||||||ANOVA||The Mean Difference represents the change in wrinkle scores from baseline (Day 0) to follow-up at Week 8, Week 12, or Week 16. For example, a Mean Difference of 1.0 indicates a 1-point improvement from baseline to Week 16 (Week 16 - baseline score).|||||1.000
72412080|NCT02819726|144332214|EQUIVALENCE|Standard acceptance limits for bioequivalence (80.00% to 125.00%) for all treatment comparisons|GLS Mean Ratio|104.03|||||TWO_SIDED|90.0|97.54|110.95||||||The statistical comparison of the loge-transformed primary parameters between treatments is based on an analysis of variance (ANOVA) model with fixed effect for treatment||110.95|97.54|
72546709|NCT00782509|144622663|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.207|STANDARD_ERROR_OF_MEAN|0.037|<|0.0001||95.0|0.133|0.28|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.280|0.133|<0.0001
72546710|NCT00782509|144622663|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.211|STANDARD_ERROR_OF_MEAN|0.037|<|0.0001||95.0|0.138|0.285|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.285|0.138|<0.0001
72412081|NCT02819726|144332215|EQUIVALENCE|Standard acceptance limits for bioequivalence (80.00% to 125.00%) for all treatment comparisons|GLS Mean Ratio|89.08|||||TWO_SIDED|90.0|77.2|102.79||||||The statistical comparison of the loge-transformed primary parameters between treatments is based on an analysis of variance (ANOVA) model with fixed effect for treatment||102.79|77.20|
72546711|NCT00782509|144622664|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.142|STANDARD_ERROR_OF_MEAN|0.047||0.0028||95.0|0.049|0.235|||ANCOVA|Treatment, tiotropium stratum and baseline as fixed effects|Olo 5 mcg qd minus Placebo|||0.235|0.049|0.0028
72546712|NCT00782509|144622664|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.156|STANDARD_ERROR_OF_MEAN|0.048||0.0013||95.0|0.061|0.25|||ANCOVA|Treatment, tiotropium stratum and baseline as fixed effects|Olo 10 mcg qd minus Placebo|||0.250|0.061|0.0013
72546713|NCT00782509|144622665|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.36|STANDARD_ERROR_OF_MEAN|4.959||0.0072|TWO_SIDED|95.0|3.622|23.099|||ANCOVA|non-MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.||||23.099|3.622|0.0072
72546714|NCT00782509|144622665|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|20.934|STANDARD_ERROR_OF_MEAN|4.894|<|0.0001|TWO_SIDED|95.0|11.323|30.545|||ANCOVA|non-MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.||||30.545|11.323|<0.0001
72546715|NCT00782509|144622666|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.456|STANDARD_ERROR_OF_MEAN|5.201||0.0169|TWO_SIDED|95.0|2.242|22.67|||ANCOVA|non-MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.||||22.670|2.242|0.0169
72546716|NCT00782509|144622666|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|20.653|STANDARD_ERROR_OF_MEAN|5.132|<|0.0001|TWO_SIDED|95.0|10.574|30.731|||ANCOVA|non-MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.||||30.731|10.574|<0.0001
72546717|NCT00782509|144622667|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.416|STANDARD_ERROR_OF_MEAN|0.127||0.0011|TWO_SIDED|95.0|-0.665|-0.167|||ANCOVA|non-MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.||||-0.167|-0.665|0.0011
72546718|NCT00782509|144622667|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.513|STANDARD_ERROR_OF_MEAN|0.125|<|0.0001|TWO_SIDED|95.0|-0.76|-0.267|||ANCOVA|non-MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.||||-0.267|-0.760|<0.0001
72546719|NCT00782509|144622668|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.42|STANDARD_ERROR_OF_MEAN|0.157||0.0077|TWO_SIDED|95.0|-0.729|-0.111|||ANCOVA|non-MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.||||-0.111|-0.729|0.0077
72546720|NCT00782509|144622668|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.76|STANDARD_ERROR_OF_MEAN|0.155|<|0.0001||95.0|-1.065|-0.456|||ANCOVA|non-MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.||||-0.456|-1.065|<0.0001
72412082|NCT02819726|144332215|EQUIVALENCE|Standard acceptance limits for bioequivalence (80.00% to 125.00%) for all treatment comparisons|GLS Mean Ratio|102.56|||||TWO_SIDED|90.0|88.72|118.56||||||The statistical comparison of the loge-transformed primary parameters between treatments is based on an analysis of variance (ANOVA) model with fixed effect for treatment||118.56|88.72|
72546721|NCT00782509|144622669|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.837|STANDARD_ERROR_OF_MEAN|0.252||0.001|TWO_SIDED|95.0|-1.333|-0.342|||ANCOVA|non-MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.||||-0.342|-1.333|0.0010
72546722|NCT00782509|144622669|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.278|STANDARD_ERROR_OF_MEAN|0.249|<|0.0001|TWO_SIDED|95.0|-1.767|-0.789|||ANCOVA|non-MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.||||-0.789|-1.767|<0.0001
72546723|NCT00782509|144622670|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.1||0.0122||95.0|-0.5|-0.1|||Mixed Models Analysis|Model included treatment, tiotropium stratum, visit and treatment-by-visit interaction as fixed effects, patient as random.|Olo 5 mcg qd minus Placebo|||-0.1|-0.5|0.0122
72546724|NCT00782509|144622670|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.1||0.0008||95.0|-0.6|-0.1|||Mixed Models Analysis|Model included treatment, tiotropium stratum, visit and treatment-by-visit interaction as fixed effects, patient as random.|Olo 10 mcg qd minus Placebo|||-0.1|-0.6|0.0008
72546725|NCT00782509|144622671|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.1||0.0028||95.0|-0.5|-0.1|||Mixed Models Analysis|Model included treatment, tiotropium stratum, visit and treatment-by-visit interaction as fixed effects, patient as random.|Olo 5 mcg qd minus Placebo|||-0.1|-0.5|0.0028
72546726|NCT00782509|144622671|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.1||0.0169||95.0|-0.5|0.0|||Mixed Models Analysis|Model included treatment, tiotropium stratum, visit and treatment-by-visit interaction as fixed effects, patient as random.|Olo 10 mcg qd minus Placebo|||-0.0|-0.5|0.0169
72546727|NCT00782509|144622672|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.1||0.018||95.0|-0.5|0.0|||Mixed Models Analysis|Model included treatment, tiotropium stratum, visit and treatment-by-visit interaction as fixed effects, patient as random.|Olo 5 mcg qd minus Placebo|||-0.0|-0.5|0.0180
72546728|NCT00782509|144622672|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.1||0.0015||95.0|-0.6|-0.1|||Mixed Models Analysis|Model included treatment, tiotropium stratum, visit and treatment-by-visit interaction as fixed effects, patient as random.|Olo 10 mcg qd minus Placebo|||-0.1|-0.6|0.0015
72546729|NCT00782509|144622673|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.1||0.1313||95.0|-0.4|0.0|||Mixed Models Analysis|Model included treatment, tiotropium stratum,visit and treatment-by-visit interaction as fixed effects, patient as random.|Olo 5 mcg qd minus Placebo|||0.0|-0.4|0.1313
72546730|NCT00782509|144622673|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.1||0.0089||95.0|-0.5|-0.1|||Mixed Models Analysis|Model included treatment, tiotropium stratum visit and treatment-by-visit interaction as fixed effects, patient as random.|Olo 10 mcg qd minus Placebo|||-0.1|-0.5|0.0089
72546731|NCT00782509|144622674|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.993|STANDARD_ERROR_OF_MEAN|0.187||0.9853|TWO_SIDED|95.0|0.687|1.436|||Log Rank|Model included a stratification factor for tiotropium use stratum and a covariate for treatment group|Comparison of Olo 5 mcg qd to placebo across stratum|||1.436|0.687|0.9853
72546732|NCT00782509|144622674|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.241|STANDARD_ERROR_OF_MEAN|0.222||0.2344|TWO_SIDED|95.0|0.873|1.763|||Log Rank|Model included a stratification factor for tiotropium use stratum and a covariate for treatment group|Comparison of Olo 10 mcg qd to placebo across stratum|||1.763|0.873|0.2344
72546733|NCT00782509|144622675|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.05|STANDARD_ERROR_OF_MEAN|0.438||0.9035|TWO_SIDED|95.0|0.463|2.38|||Log Rank|Model included a stratification factor for tiotropium use stratum and a covariate for treatment group|Comparison of Olo 5 mcg qd to placebo across stratum|||2.380|0.463|0.9035
72580777|NCT05724589|144691233|SUPERIORITY|Repeated measures ANOVA was used to detect any change in facial melanin levels due to the intervention.|Mean Difference (Final Values)|-3.458||||1|TWO_SIDED|||||The p-value indicates no statistically significant change in facial melanin index over time. The p-value was not adjusted for multiple comparisons. Statistical significance was pre-specified at p \< 0.05.|ANOVA|Sphericity assumptions were checked and addressed as needed (e.g., Greenhouse-Geisser correction).|The estimation parameter reflects the mean change in melanin index from baseline to week 16. Baseline was used as the reference point in the analysis.|The statistical analysis assessed changes in facial melanin index after serum application using repeated measures ANOVA. This method evaluated differences across multiple time points (Baseline, Week 8, Week 12, and Week 16) within the same participants, accounting for the correlated nature of repeated measures.||||1.000
72580778|NCT05724589|144691234|SUPERIORITY|A descriptive analysis was performed. No hypothesis testing or power calculation was conducted for this outcome.|percentage of participants at week 16|44.0||||1|TWO_SIDED|||||The p-value reflects descriptive analysis of SGAIS improvement scores; no statistical testing for significance was conducted.|Descriptive|The evaluation involved categorical SGAIS ratings assigned by two independent dermatologists.|This estimate reflects the proportion of participants rated as showing mild improvement on the SGAIS at Week 16, as detailed in the tabular data.|Improvement in facial appearance was assessed using the Subject Global Aesthetic Improvement Scale (SGAIS), rated independently by two board-certified dermatologists at multiple time points (8, 12, and 16 weeks).||||1.000
72580779|NCT05724589|144691235|SUPERIORITY|Descriptive summary statistics were used to report satisfaction at multiple time points. No inferential testing was performed.|percentage of participants at week 16|75.0|||||TWO_SIDED||||||Descriptive|No formal statistical hypothesis testing was performed.|The estimated percentage reflects participants who reported a satisfaction score of 2 or 3 at week 16.|"Satisfaction was assessed at weeks 8, 12, and 16 using a quartile scale:~0 = Unsatisfied, 1 = Slightly satisfied, 2 = Satisfied, 3 = Very satisfied. One participant was lost to follow-up after week 12."||||
72580780|NCT05724589|144691236|SUPERIORITY|This was a descriptive safety analysis. No inferential hypothesis testing was conducted.|Percentage adverse events by week 16|0.0|||||TWO_SIDED||||||Descriptive|No formal statistical test was conducted.|Descriptive summaries of adverse event incidence are reported in the results tables.|The analysis population includes 28 participants. One subject was lost to follow-up at week 12. Adverse events were assessed through video calls at weeks 2 and 4, and in-person visits at 2, 3, and 4 months.||||
72580781|NCT02329015|144691237|SUPERIORITY_OR_OTHER||Slope|0.58||||0.54|TWO_SIDED|95.0|-1.25|2.41|||Regression, Logistic|||Model 1: An intent to treat analyses was performed determining effect of group assignment on academic performance while controlling for previous year GPA.||2.41|-1.25|0.54
72580782|NCT02329015|144691237|SUPERIORITY_OR_OTHER||Slope|1.67||||0.08|TWO_SIDED|95.0|-0.21|3.55|||Regression, Linear|||Model 2: As active participation between groups was significantly different a second intent to treat analysis was performed which added to Model 1 (controlling for previous year GPA) by controlling for active participation.||3.55|-0.21|0.08
72580783|NCT02329015|144691237|SUPERIORITY_OR_OTHER||Slope|2.7||||0.009|TWO_SIDED|95.0|0.69|4.71|||Regression, Linear|||Model 3: Per Protocol Analysis: it was hypothesized that any benefit of yoga education would only accrue if the student was assigned to yoga classes and actively participated in the class. A third Model was fit with an interaction term for class assignment and class participation.||4.71|0.69|0.009
72580784|NCT02329015|144691238|SUPERIORITY_OR_OTHER|||||||0.301|||||||Regression, Linear|||Analysis of the Voluntary subscale of the Response to Stress Questionnaire||||0.301
72546734|NCT00782509|144622675|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.958|STANDARD_ERROR_OF_MEAN|0.408||0.9304|TWO_SIDED|95.0|0.415|2.209|||Log Rank|Model included a stratification factor for tiotropium use stratum and a covariate for treatment group|Comparison of Olo 10 mcg qd to placebo across stratum|||2.209|0.415|0.9304
72546735|NCT00782509|144622676|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.09|STANDARD_ERROR_OF_MEAN|0.233||0.669|TWO_SIDED|95.0|0.717|1.657|||Log Rank|Model included a stratification factor for tiotropium use stratum and a covariate for treatment group|Comparison of Olo 5 mcg qd to placebo across stratum|||1.657|0.717|0.6690
72546736|NCT00782509|144622676|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.344|STANDARD_ERROR_OF_MEAN|0.273||0.1437|TWO_SIDED|95.0|0.902|2.002|||Log Rank|Model included a stratification factor for tiotropium use stratum and a covariate for treatment group|Comparison of Olo 10 mcg qd to placebo across stratum|||2.002|0.902|0.1437
72546737|NCT00782509|144622677|SUPERIORITY_OR_OTHER||Incidence rate ratio|1.188|STANDARD_ERROR_OF_MEAN|0.2251||0.3637|TWO_SIDED|95.0|0.8188|1.7234|||Negative binomial regression|Regression of treatment effect using tiotropium strata as a covariate, a log link function and log(exposure) as offset.|Olo 5 mcg qd minus Placebo|||1.7234|0.8188|0.3637
72546738|NCT00782509|144622677|SUPERIORITY_OR_OTHER||Incidence rate ratio|1.2822|STANDARD_ERROR_OF_MEAN|0.2403||0.1853|TWO_SIDED|95.0|0.8874|1.8527|||Negative binomial regression|Regression of treatment effect using tiotropium strata as a covariate, a log link function and log(exposure) as offset.|Olo 10 mcg qd minus Placebo|||1.8527|0.8874|0.1853
72546739|NCT00782509|144622678|SUPERIORITY_OR_OTHER||Incidence rate ratio|1.0314|STANDARD_ERROR_OF_MEAN|0.4664||0.9455|TWO_SIDED|95.0|0.4244|2.5063|||Negative binomial regression|Regression of treatment effect using tiotropium strata as a covariate, a log link function and log(exposure) as offset.|Olo 5 mcg qd minus Placebo|||2.5063|0.4244|0.9455
72546740|NCT00782509|144622678|SUPERIORITY_OR_OTHER||Incidence rate ratio|1.1273|STANDARD_ERROR_OF_MEAN|0.5028||0.7883|TWO_SIDED|95.0|0.4696|2.7064|||Negative binomial regression|Regression of treatment effect using tiotropium strata as a covariate, a log link function and log(exposure) as offset.|Olo 10 mcg qd minus Placebo|||2.7064|0.4696|0.7883
72546741|NCT00782509|144622679|SUPERIORITY_OR_OTHER||Incidence rate ratio|1.2846|STANDARD_ERROR_OF_MEAN|0.2803||0.2514|TWO_SIDED|95.0|0.837|1.9717|||Negative binomial regression|Regression of treatment effect using tiotropium strata as a covariate, a log link function and log(exposure) as offset.|Olo 5 mcg qd minus Placebo|||1.9717|0.8370|0.2514
72546742|NCT00782509|144622679|SUPERIORITY_OR_OTHER||Incidence rate ratio|1.3373|STANDARD_ERROR_OF_MEAN|0.2901||0.1807|TWO_SIDED|95.0|0.8735|2.0474|||Negative binomial regression|Regression of treatment effect using tiotropium strata as a covariate, a log link function and log(exposure) as offset.|Olo 10 mcg qd minus Placebo|||2.0474|0.8735|0.1807
72546743|NCT00220701|144622710|SUPERIORITY_OR_OTHER||F statistics|2.82||||0.1|TWO_SIDED||||||Repeated Measures ANOVA|||||||0.10
72546744|NCT01176448|144622717|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|With 12 scars (or pairs to compare), our power calculation had a 95 percent probability that the study will detect a treatment difference at a two-sided 0.05 percent significance level, if a significant difference between treatments is 1.5 units (based on a 0-4 scale as mentioned above). This is based on the assumption that the within-patient standard deviation of the response variable is 0.5 units.||||||0.77||95.0||||Appropriately powered, this study failed to reject the null hypothesis that fraxel achieves a similar cosmetic result at 3 months when compared to dermabrasion.|Wilcoxon (Mann-Whitney)|||efficacy outcomes analyzed by 3 surgeons blinded to the treatment and scars evaluated by halves comparing pre-treatment photos to 3-month photos and given a score on the quartile scale described in table 1. The ordinal rater scores of each evaluator were then averaged, and Wilcoxon Signed Ranks performed on the group's scores. (table 5) There were 4 Fraxel winners, 4 Dermabrasion winners, and 4 ties. There was a p value of 0.77 indicating no significant difference between the categories||||.77
72546745|NCT00755326|144622718|SUPERIORITY|||||||0.05|||||||t-test, 2 sided|||||||0.05
72546746|NCT04041570|144622734|OTHER|t-tests were only employed to determine which individuals were responders. Response rates with 95% Clopper-Pearson confidence intervals were reported within group.||||||0.05||||||The p-value was not adjusted for multiple comparisons and was only used to assess whether participants had a positive response or not.|t-test, 1 sided|This test was only used to determine whether participants were positive responders or not.||Statistical testing was performed within group and not between groups. Positivity for an individual was determined if there was a significant (p-value\<0.05) increase (one-sided test) in the ELISA titers at week 4 when compared to those at baseline. For each participant a t-test was performed to compare the triplicate baseline titers to their triplicate week 4 titers. The proportion of positive responses and associated Clopper-Pearson 95% was calculated within group.|For each participant, a positive response was defined as a significant increase in ELISA titer post vaccination (Week 4) from baseline (Week 0). Within each participant, a t-test is performed to compare the triplicate readings (replicates 1-3) post vaccination versus the triplicate readings at baseline. A participant is defined as a positive responder if one-sided t-test has p-value \< 0.05. The proportion of responders and associated 95% Clopper-Pearson Confidence Intervals were calculated.|||0.05
72546747|NCT03588390|144622741|OTHER||Slope|0.696|STANDARD_ERROR_OF_MEAN|0.0971|||TWO_SIDED|95.0|0.5006|0.8914|||||Based on the estimate for slope parameter (β), a 2-sided 95% CI for the slope was computed. Perfect dose proportionality would correspond to a slope of 1. Standard error of the mean is actually standard error of slope.|The basic model for the investigation of dose proportionality was a power model that described the functional relationship between the dose and PK endpoints.||0.8914|0.5006|
72546748|NCT03588390|144622741|OTHER||Slope|0.9244|STANDARD_ERROR_OF_MEAN|0.122|||TWO_SIDED|95.0|0.6764|1.1724|||||Based on the estimate for slope parameter (β), a 2-sided 95% CI for the slope was computed. Perfect dose proportionality would correspond to a slope of 1. Standard error of the mean is actually standard error of slope.|The basic model for the investigation of dose proportionality was a power model that described the functional relationship between the dose and PK endpoints.||1.1724|0.6764|
72546749|NCT03588390|144622742|OTHER||Slope|0.6533|STANDARD_ERROR_OF_MEAN|0.0982|||TWO_SIDED|95.0|0.4556|0.851|||||Based on the estimate for slope parameter (β), a 2-sided 95% CI for the slope was computed. Perfect dose proportionality would correspond to a slope of 1. Standard error of the mean is actually standard error of slope.|The basic model for the investigation of dose proportionality was a power model that described the functional relationship between the dose and PK endpoints.||0.8510|0.4556|
72546750|NCT03588390|144622742|OTHER||Slope|0.8586|STANDARD_ERROR_OF_MEAN|0.1307|||TWO_SIDED|95.0|0.5929|1.1242|||||Based on the estimate for slope parameter (β), a 2-sided 95% CI for the slope was computed. Perfect dose proportionality would correspond to a slope of 1. Standard error of the mean is actually standard error of slope.|The basic model for the investigation of dose proportionality was a power model that described the functional relationship between the dose and PK endpoints.||1.1242|0.5929|
72546751|NCT00384033|144622743|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.1||||0.198|TWO_SIDED|95.0|-0.6|2.7||The analysis was done at a significance level of alpha = 0.05, 2-sided. Global F-test was used to adjust for multiplicity. If global F-test was significant at 0.05 level, pair wise analysis was interpreted without any further p-value adjustment.|ANCOVA|||For DVS SR 50 mg, HAM-D17 total score was evaluated using analysis of covariance (ANCOVA) with treatment and site as factors and baseline HAM-D17 score as the covariate.||2.70|-0.60|0.198
72546752|NCT00384033|144622743|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.8||||0.028|TWO_SIDED|95.0|0.2|3.4||The analysis was done at a significance level of alpha = 0.05, 2-sided. Global F-test was used to adjust for multiplicity. If global F-test was significant at 0.05 level, pair wise analysis was interpreted without any further p-value adjustment.|ANCOVA|||For DVS SR 100 mg, HAM-D17 total score was evaluated using ANCOVA with treatment and site as factors and baseline HAM-D17 score as the covariate.||3.40|0.20|0.028
72580785|NCT02273388|144691269|OTHER||Difference of adjusted means|-4.56|STANDARD_ERROR_OF_MEAN|3.61|||TWO_SIDED|90.0|-10.59|1.48|||||Comparison vs. 1 hour infusion \[2h-1h\]|Change from baseline to 5 minutes before infusion end. Linear mixed model with sequence, course, treatment (both infusion types i.e. 1 hour duration and 2 hour duration) and time as fixed effects and treatment\*time as interaction effect, as well as the continuous , fixed covariate of baseline value.||1.48|-10.59|
72580786|NCT02273388|144691269|OTHER||Difference of adjusted means|-7.14|STANDARD_ERROR_OF_MEAN|3.61|||TWO_SIDED|90.0|-13.18|-1.11|||||Comparison vs. 1hour infusion \[2h-1h\]|Change from baseline to 1 hour after infusion end. Linear mixed model with sequence, course, treatment (both infusion types i.e. 1 hour duration and 2 hour duration) and time as fixed effects and treatment\*time as interaction effect, as well as the continuous , fixed covariate of baseline value.||-1.11|-13.18|
72580787|NCT02273388|144691269|OTHER||Difference of adjusted means|-3.58|STANDARD_ERROR_OF_MEAN|3.61|||TWO_SIDED|90.0|-9.61|2.46|||||Comparison vs. 1 hour infusion \[2h-1h\]|Change from baseline to 4 hours after infusion start. Linear mixed model with sequence, course, treatment (both infusion types i.e. 1 hour duration and 2 hour duration) and time as fixed effects and treatment\*time as interaction effect, as well as the continuous , fixed covariate of baseline value.||2.46|-9.61|
72580788|NCT02273388|144691269|OTHER||Difference of adjusted means|-8.66|STANDARD_ERROR_OF_MEAN|3.61|||TWO_SIDED|90.0|-14.7|-2.63|||||Comparison vs. 1 hour \[2h-1h\]|Change from baseline to 24 hours after infusion start. Linear mixed model with sequence, course, treatment (both infusion types i.e. 1 hour duration and 2 hour duration) and time as fixed effects and treatment\*time as interaction effect, as well as the continuous , fixed covariate of baseline value.||-2.63|-14.70|
72580789|NCT04331808|144691290|SUPERIORITY||Median posterior absolute risk differenc|-9.0|||||TWO_SIDED|90.0|-21.0|3.1||Posterior probability|Bayesian analysis|Adjusted for age and centre|% Confidence Interval is % Credibility interval here|||3.1|-21.0|
72580790|NCT04331808|144691291|SUPERIORITY||Median posterior Hazard Ratio|0.58|||||TWO_SIDED|90.0|0.33|1.0||Posterior probability|Bayesian analysis|HR adjusted for age and centre|% Confidence interval is % Credible Interval here|||1.00|0.33|
72580791|NCT04331808|144691292|SUPERIORITY||Median posterior absolute risk differenc|1.7|||||TWO_SIDED|90.0|-13.6|17.1||Posterior probability|Bayesian analysis|Adjusted for age and centre|% Confidence Interval is % Credible Interval here Results are presented as the proportion not improved, so that an effective treatment would be associated with a decrease in proportion.|||17.1|-13.6|
72580792|NCT04331808|144691293|SUPERIORITY||Median posterior Hazard Ratio|1.19|||||TWO_SIDED|90.0|0.71|2.04||Posterior probability|Bayesian analysis|HR adjusted for age and centre|% Confidence interval is % Credible Interval here|||2.04|0.71|
72580793|NCT04331808|144691294|SUPERIORITY||Hazard Ratio (HR)|1.19|||||TWO_SIDED|95.0|0.4|3.55|||Regression, Cox|adjusted for age and sex||Day 14||3.55|0.40|
72580794|NCT04331808|144691294|SUPERIORITY||Cox Proportional Hazard|0.92|||||TWO_SIDED|95.0|0.33|2.53|||Regression, Cox|adjusted for age and centre||Day 28||2.53|0.33|
72580795|NCT04331808|144691294|SUPERIORITY||Cox Proportional Hazard|0.64|||||TWO_SIDED|95.0|0.25|1.65|||Regression, Cox|adjusted for age and centre||Day 90||1.65|0.25|
72580796|NCT04331808|144691294|SUPERIORITY||Hazard Ratio (HR)|0.37|||||TWO_SIDED|95.0|0.12|1.15|||Regression, Cox|adjusted for age and centre||Day 14||1.15|0.12|
72580797|NCT04331808|144691294|SUPERIORITY||Hazard Ratio (HR)|0.69|||||TWO_SIDED|95.0|0.32|1.47|||Regression, Cox|adjusted for age and centre||Day 28||1.47|0.32|
72580798|NCT04331808|144691294|SUPERIORITY||Hazard Ratio (HR)|0.67|||||TWO_SIDED|95.0|0.3|1.49|||Regression, Cox|adjusted for age and centre||Day 90||1.49|0.30|
72546753|NCT00384033|144622743|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.7||||0.047|TWO_SIDED|95.0|0.0|3.4||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|ANCOVA|||For Duloxetine 60 mg, HAM-D17 total score was evaluated using ANCOVA with treatment and site as factors and baseline HAM-D17 score as the covariate.||3.40|0.00|0.047
72546754|NCT00384033|144622744|SUPERIORITY_OR_OTHER|||||||0.11|TWO_SIDED|||||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|Cochran-Mantel-Haenszel|||For DVS SR 50 mg, CGI-I was evaluated using Cochran-Mantel-Haenszel (CMH) test with treatment as a factor and controlling for center.||||0.110
72546755|NCT00384033|144622744|SUPERIORITY_OR_OTHER|||||||0.009|TWO_SIDED|||||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|Cochran-Mantel-Haenszel|||For DVS SR 100 mg, CGI-I was evaluated using CMH test with treatment as a factor and controlling for center.||||0.009
72546756|NCT00384033|144622744|SUPERIORITY_OR_OTHER|||||||0.008|TWO_SIDED|||||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|Cochran-Mantel-Haenszel|||For Duloxetine 60 mg, CGI-I was evaluated using CMH test with treatment as a factor and controlling for center.||||0.008
72546757|NCT00384033|144622745|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2||||0.248|TWO_SIDED|95.0|-0.1|0.4||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|ANCOVA|||For DVS SR 50 mg, CGI-S was evaluated using ANCOVA with treatment and site as factors and baseline CGI-S score as the covariate.||0.40|-0.10|0.248
72546758|NCT00384033|144622745|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3||||0.011|TWO_SIDED|95.0|0.1|0.6||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|ANCOVA|||For DVS SR 100 mg, CGI-S was evaluated using ANCOVA with treatment and site as factors and baseline CGI-S score as the covariate.||0.60|0.10|0.011
72580799|NCT04331808|144691295|SUPERIORITY||Median posterior OR|0.6|||||TWO_SIDED|95.0|0.27|1.28|||Proportionnal odds model|Bayesian analysis. Adjusted for age and centre|% Confidence Interval is % Credible Interval here|Day 4||1.28|0.27|
72546759|NCT00384033|144622745|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.3||||0.026|TWO_SIDED|95.0|0.0|0.6||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|ANCOVA|||For Duloxetine 60 mg, CGI-S was evaluated using ANCOVA with treatment and site as factors and baseline CGI-S score as the covariate.||0.60|0.00|0.026
72546760|NCT00384033|144622746|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.7||||0.149|TWO_SIDED|95.0|-0.6|4.0||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|ANCOVA|||For DVS SR 50 mg, MADRS total score was evaluated using ANCOVA with treatment and site as factors and baseline MADRS score as the covariate.||4.00|-0.60|0.149
72546761|NCT00384033|144622746|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.3||||0.004|TWO_SIDED|95.0|1.1|5.6||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|ANCOVA|||For DVS SR 100 mg, MADRS total score was evaluated using ANCOVA with treatment and site as factors and baseline MADRS score as the covariate.||5.60|1.10|0.004
72580800|NCT04331808|144691295|SUPERIORITY||Median posterior OR|0.86|||||TWO_SIDED|95.0|0.43|1.71|||Proportionnal odds model|Bayesian analysis. Adjusted for age and centre||Day 7|% Confidence Interval is % Credible Interval here|1.71|0.43|
72580801|NCT04331808|144691295|SUPERIORITY||Median posterior OR|0.76|||||TWO_SIDED|95.0|0.4|1.42|||Proportionnal odds model|Bayesian analysis. Adjusted for age and sex|% Confidence Interval is % Credible Interval here|Day 14||1.42|0.40|
72580802|NCT04331808|144691295|SUPERIORITY||Median posterior OR|0.85|||||TWO_SIDED|95.0|0.39|1.82|||Proportionnal odds model|Bayesian analysis. Adjusted for age and centre||Day 4|% Confidence Interval is % Credible Interval here|1.82|0.39|
72546762|NCT00384033|144622746|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.4||||0.005|TWO_SIDED|95.0|1.1|5.8||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|ANCOVA|||For Duloxetine 60 mg, MADRS total score was evaluated using ANCOVA with treatment and site as factors and baseline MADRS score as the covariate.||5.80|1.10|0.005
72546763|NCT00384033|144622747|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.12||||0.473|TWO_SIDED|95.0|-0.22|0.46||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|ANCOVA|||For DVS SR 50 mg, lassitude item of the MADRS score was evaluated using ANCOVA with treatment and site as factors and baseline lassitude item of the MADRS score as the covariate.||0.46|-0.22|0.473
72580803|NCT04331808|144691295|SUPERIORITY||Median posterior OR|0.69|||||TWO_SIDED|95.0|0.32|1.47|||Proportionnal odds model|Bayesian analysis. Adjusted for age and centre|% Confidence Interval is % Credible Interval here|Day 7||1.47|0.32|
72580804|NCT04331808|144691295|SUPERIORITY||Median posterior OR|0.68|||||TWO_SIDED|95.0|0.32|1.43|||Proportionnal odds model|Bayesian analysis. Adjusted for age and centre|% Confidence Interval is % Credible Interval here|Day 14||1.43|0.32|
72580805|NCT04331808|144691296|SUPERIORITY||Mean Difference (Net)|-2.5|||||TWO_SIDED|95.0|-6.9|1.7||adjusted on age and centre||||||1.7|-6.9|
72580806|NCT04331808|144691297|SUPERIORITY||Hazard Ratio (HR)|1.41|||||TWO_SIDED|95.0|0.98|2.01|||Fine-Gray model|adjusted for age and centre||Day 28||2.01|0.98|
72580807|NCT04331808|144691297|SUPERIORITY||Hazard Ratio (HR)|1.44|||||TWO_SIDED|95.0|0.82|2.52|||Fine-Gray model|||Day 28||2.52|0.82|
72580808|NCT04331808|144691297|SUPERIORITY||Hazard Ratio (HR)|1.28|||||TWO_SIDED|95.0|0.8|2.03|||Fine-Gray model|adjusted on age and centre||Day 90||2.03|0.80|
72580809|NCT04331808|144691298|SUPERIORITY||Hazard Ratio (HR)|1.52|||||TWO_SIDED|95.0|1.02|2.27|||Fine-Gray model|adjusted on age and centre||Day 28||2.27|1.02|
72580810|NCT04331808|144691298|SUPERIORITY||Hazard Ratio (HR)|1.45|||||TWO_SIDED|95.0|0.8|2.63|||Fine-Gray model|adjusted for age and centre||Day 28||2.63|0.80|
72580811|NCT04331808|144691298|SUPERIORITY||Hazard Ratio (HR)|1.35|||||TWO_SIDED|95.0|0.84|2.17|||Fine-Gray model|adjusted for age and centre||Day 90||2.17|0.84|
72580812|NCT04331808|144691299|SUPERIORITY||Hazard Ratio (HR)|1.15|||||TWO_SIDED|95.0|0.73|1.81|||Fine-Gray model|adjusted on age and centre||Day 28||1.81|0.73|
72580813|NCT04331808|144691299|SUPERIORITY||Hazard Ratio (HR)|1.28|||||TWO_SIDED|95.0|0.73|2.24|||Fine-Gray model|adjusted on age and centre||Day 90||2.24|0.73|
72580814|NCT00619060|144691333|SUPERIORITY_OR_OTHER|||||||0.01|TWO_SIDED|95.0|||||Binomial|||||||0.01
72580815|NCT03953612|144691346|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|Linear mixed effects||||||<.001
72580816|NCT03953612|144691347|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|Linear mixed effects||||||<.001
72580817|NCT03953612|144691348|SUPERIORITY|||||||0.7|||||||Mixed Models Analysis|Linear mixed effects||||||0.7
72580818|NCT03953612|144691349|SUPERIORITY|||||||0.0001|||||||ANOVA|||||||0.0001
72580819|NCT03953612|144691350|SUPERIORITY|||||||0.042|||||||. Negative binomial regression models|||||||0.042
72580820|NCT03953612|144691351|SUPERIORITY|||||||0.125|||||||. Negative binomial regression models|||||||0.125
72580821|NCT02028676|144691352|NON_INFERIORITY_OR_EQUIVALENCE|Upper 95% confidence interval for the hazard ratio was 1.64, see other analysis for this endpoint for details|Hazard Ratio (HR)|1.13||||0.59|TWO_SIDED|95.0|0.73|1.73|||Log Rank|Adjusted for randomization stratification factors|Hazard ratio is CDM vs LCM|||1.73|0.73|0.59
72580822|NCT02028676|144691352|NON_INFERIORITY_OR_EQUIVALENCE|With assumptions detailed above, \>90% power and one-sided alpha=0.05, 1160 children would be required to exclude an increase in progression rate of 1.6% from 2.5% to 4.1% per year in the CDM arm (upper 95% confidence limit of LCM: CDM hazard ratio 1.64).|Risk Difference (RD)|0.32||||0.43|TWO_SIDED|95.0|-0.47|1.12|||Comparison of poisson rates|Statistical analysis plan specified that p-value was to be calculated from the log-rank test, so not provided for the risk difference|Difference is CDM minus LCM|"Assumptions:~* control group (LCM) event rate 3% per year~* rates are reduced to 2% per year in the best of the induction-maintenance arms leading to an overall rate of progression to new WHO stage 4 or death of 2.5%~* recruitment is over 1.5 years and follow-up for a minimum further 3.5 years.~* cumulative loss to follow-up is 10% at 5 years. See below for rest of sample size as this box is not big enough."||1.12|-0.47|0.43
72580823|NCT02028676|144691353|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.98||||0.83|TWO_SIDED|95.0|0.83|1.16|||Log Rank|Adjusted for randomization stratification factors|Hazard ratio is CDM vs LCM|||1.16|0.83|0.83
72580824|NCT02028676|144691354|SUPERIORITY_OR_OTHER|||||||0.33|||||||Regression, Linear|Global test with 2df, adjusted for randomization stratification factors||Assuming a standard deviation for the change in CD4 percentage from baseline to 72 weeks of 10% (slightly higher than that observed in the PENTA 5 trial) 1200 children would provide at least 80% power to detect a difference in change in CD4% from baseline of more than 2.5% across the 3 groups (F-test with 2-sided alpha=0.05) assuming 20% missing data (loss to follow-up during the first year plus failure to attend the week 72 visit/missing sample).||||0.33
72580825|NCT02028676|144691355|SUPERIORITY_OR_OTHER|||||||0.69|||||||Regression, Linear|Global test with 2df, adjusted for randomization stratification factors||||||0.69
72580826|NCT02028676|144691356|SUPERIORITY_OR_OTHER|||||||0.0001|||||||Log Rank|Global test with 2df, adjusted for randomization stratification factors||||||0.0001
72580827|NCT02028676|144691356|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.32||||0.01|TWO_SIDED|95.0|1.07|1.63|||Regression, Cox||HR is Arm B vs A|||1.63|1.07|0.01
72580828|NCT02028676|144691356|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.58|||<|0.001|TWO_SIDED|95.0|1.29|1.94|||Regression, Cox|||||1.94|1.29|<0.001
72580829|NCT02028676|144691357|NON_INFERIORITY_OR_EQUIVALENCE|631 children would be required to exclude a 12% lower suppression rate in the once daily group with at least 90% power and two-sided alpha=0.05 (lower 95% confidence limit of difference between once and twice daily -12%, the non-inferiority margin). 630 children retains at least 80% (rather than 90%) power to exclude a 10% (rather than 12%) lower suppression rate in the once daily group with one-sided alpha=0.05 (lower 90% confidence limit of difference between once and twice daily -10%).|Risk Difference (RD)|-1.6||||0.65|TWO_SIDED|95.0|-8.4|5.2|||Chi-squared||Difference in suppression \<80 copies/ml in once-daily minus twice-daily|||5.2|-8.4|0.65
72580830|NCT02028676|144691359|NON_INFERIORITY_OR_EQUIVALENCE|With assumptions above, at least 80% power and one-sided alpha=0.05, 947 children would be required in the stop/continue cotrimoxazole prophylaxis comparison to exclude an increase in hospitalisation/death rate of 3% from 5% to 8% per year in the stop cotrimoxazole arm (upper 95% confidence limit of stop:continue hazard ratio 1.6).|Hazard Ratio (HR)|1.64||||0.007|TWO_SIDED|95.0|1.14|2.37|||Log Rank||Hazard ratio is stop vs continue.|"Assumptions~* 5% of children receiving daily cotrimoxazole prophylaxis have a new hospitalisation or death per year~* recruitment starts 1 July 2009 with 10% children (those already on ART for \>96 weeks) entering immediately, and then the remaining children recruited over the following 15 months as they reach 96 weeks on ART. Follow-up is until March 2012.~* cumulative loss to follow-up at March 2012 is 10%. See below for further details as box is not big enough"||2.37|1.14|0.007
72580831|NCT02028676|144691359|NON_INFERIORITY_OR_EQUIVALENCE|With assumptions above, at least 80% power and one-sided alpha=0.05, 947 children would be required in the stop/continue cotrimoxazole prophylaxis comparison to exclude an increase in hospitalisation/death rate of 3% from 5% to 8% per year in the stop cotrimoxazole arm (upper 95% confidence limit of stop:continue hazard ratio 1.6).|Risk Difference (RD)|4.0||||0.006|TWO_SIDED|95.0|0.8|7.2|||Poisson regression for risk difference||Risk difference is stop vs continue.|"Assumptions~* 5% of children receiving daily cotrimoxazole prophylaxis have a new hospitalisation or death per year~* recruitment starts 1 July 2009 with 10% children (those already on ART for \>96 weeks) entering immediately, and then the remaining children recruited over the following 15 months as they reach 96 weeks on ART. Follow-up is until March 2012.~* cumulative loss to follow-up at March 2012 is 10%. See below for further details as box is not big enough."||7.2|0.8|0.006
72580832|NCT02028676|144691360|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.2||||0.33|TWO_SIDED|95.0|0.83|1.72|||Log Rank||Hazard ratio is stop vs continue.|||1.72|0.83|0.33
72546764|NCT00384033|144622747|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.27||||0.119|TWO_SIDED|95.0|-0.07|0.61||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|ANCOVA|||For DVS SR 100 mg, lassitude item of the MADRS score was evaluated using ANCOVA with treatment and site as factors and baseline lassitude item of the MADRS score as the covariate.||0.61|-0.07|0.119
72546765|NCT00384033|144622747|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.06||||0.71|TWO_SIDED|95.0|-0.27|0.4||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|ANCOVA|||For Duloxetine 60 mg, lassitude item of the MADRS score was evaluated using ANCOVA with treatment and site as factors and baseline lassitude item of the MADRS score as the covariate.||0.40|-0.27|0.710
72546766|NCT00384033|144622748|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.6||||0.215|TWO_SIDED|95.0|-0.3|1.5||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|ANCOVA|||For DVS SR 50 mg, HAM-D6 score was evaluated using ANCOVA with treatment and site as factors and baseline HAM-D6 score as the covariate.||1.50|-0.30|0.215
72546767|NCT00384033|144622748|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.3||||0.005|TWO_SIDED|95.0|0.4|2.3||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|ANCOVA|||For DVS SR 100 mg, HAM-D6 score was evaluated using ANCOVA with treatment and site as factors and baseline HAM-D6 score as the covariate.||2.30|0.40|0.005
72546768|NCT00384033|144622748|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.1||||0.024|TWO_SIDED|95.0|0.2|2.1||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|ANCOVA|||For Duloxetine 60 mg, HAM-D6 score was evaluated using ANCOVA with treatment and site as factors and baseline HAM-D6 score as the covariate.||2.10|0.20|0.024
72546769|NCT00384033|144622749|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.53||||0.1|TWO_SIDED|95.0|-0.1|1.17||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|ANCOVA|||For DVS SR 50 mg, HAM-D energy subscale score was evaluated using ANCOVA with treatment and site as factors and baseline HAM-D energy score as the covariate.||1.17|-0.10|0.100
72546770|NCT00384033|144622749|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.79||||0.014|TWO_SIDED|95.0|0.16|1.42||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|ANCOVA|||For DVS SR 100 mg, HAM-D energy subscale score was evaluated using ANCOVA with treatment and site as factors and baseline HAM-D energy score as the covariate.||1.42|0.16|0.014
72580833|NCT02028676|144691361|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.84||||0.45|TWO_SIDED|95.0|0.49|1.44|||Log Rank|Adjusted for randomization stratification factors|Hazard ratio is CDM vs LCM|||1.44|0.49|0.45
72580834|NCT02028676|144691361|SUPERIORITY_OR_OTHER|||||||0.43|||||||Log Rank|Global test with 2df, adjusted for randomization stratification factors||||||0.43
72412083|NCT02819726|144332215|EQUIVALENCE|Standard acceptance limits for bioequivalence (80.00% to 125.00%) for all treatment comparisons|GLS Mean Ratio|115.13|||||TWO_SIDED|90.0|99.51|133.21||||||The statistical comparison of the loge-transformed primary parameters between treatments is based on an analysis of variance (ANOVA) model with fixed effect for treatment||133.21|99.51|
72580835|NCT02028676|144691361|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.66||||0.23|TWO_SIDED|95.0|0.33|1.31|||Regression, Cox|Adjusted for randomization stratification factors|Hazard ratio is Arm B vs A|||1.31|0.33|0.23
72546771|NCT00384033|144622749|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.72||||0.032|TWO_SIDED|95.0|0.06|1.38||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|ANCOVA|||For Duloxetine 60 mg, HAM-D energy subscale score was evaluated using ANCOVA with treatment and site as factors and baseline HAM-D energy score as the covariate.||1.38|0.06|0.032
72546772|NCT00384033|144622750|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||0.445|TWO_SIDED|95.0|-0.2|0.5||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|ANCOVA|||For DVS SR 50 mg, Covi anxiety scale was evaluated using ANCOVA with treatment and site as factors and baseline Covi anxiety score as the covariate.||0.50|-0.20|0.445
72546773|NCT00384033|144622750|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3||||0.056|TWO_SIDED|95.0|0.0|0.7||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|ANCOVA|||For DVS SR 100 mg, Covi anxiety scale was evaluated using ANCOVA with treatment and site as factors and baseline Covi anxiety score as the covariate.||0.70|-0.00|0.056
72546774|NCT00384033|144622750|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.5||||0.006|TWO_SIDED|95.0|0.1|0.9||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|ANCOVA|||For Duloxetine 60 mg, Covi anxiety scale was evaluated using ANCOVA with treatment and site as factors and baseline Covi anxiety score as the covariate.||0.90|0.10|0.006
72580836|NCT02028676|144691361|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.97||||0.93|TWO_SIDED|95.0|0.52|1.81|||Regression, Cox|Adjusted for randomization stratification factors|Hazard ratio is Arm C vs A|||1.81|0.52|0.93
72580837|NCT02028676|144691362|SUPERIORITY_OR_OTHER|||||||0.89|||||||Log Rank|Global test with 2df, adjusted for randomization stratification factors||||||0.89
72580838|NCT02028676|144691362|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.89||||0.64|TWO_SIDED|95.0|0.53|1.48|||Regression, Cox|Adjusted for randomization stratification factors|Hazard ratio is Arm B vs A|||1.48|0.53|0.64
72580839|NCT02028676|144691362|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.91||||0.71|TWO_SIDED|95.0|0.54|1.52|||Regression, Cox|Adjusted for randomization stratification factors|Hazard ratio is Arm C vs A|||1.52|0.54|0.71
72546775|NCT00384033|144622751|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.5||||0.124|TWO_SIDED|95.0|-0.9|7.9||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|ANCOVA|||For DVS SR 50 mg, overall VAS-PI score was evaluated using ANCOVA with treatment and site as factors and baseline VAS-PI score as the covariate.||7.90|-0.90|0.124
72546776|NCT00384033|144622751|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.7||||0.035|TWO_SIDED|95.0|0.3|9.1||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|ANCOVA|||For DVS SR 100 mg, overall VAS-PI score was evaluated using ANCOVA with treatment and site as factors and baseline VAS-PI score as the covariate.||9.10|0.30|0.035
72546777|NCT00384033|144622751|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|4.1||||0.093|TWO_SIDED|95.0|-0.7|8.8||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|ANCOVA|||For Duloxetine 60 mg, overall VAS-PI score was evaluated using ANCOVA with treatment and site as factors and baseline VAS-PI score as the covariate.||8.80|-0.70|0.093
72580840|NCT02028676|144691363|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.0||||0.98|TWO_SIDED|95.0|0.73|1.38|||Log Rank|Adjusted for randomization stratification factors|Hazard ratio is CDM vs LCM|||1.38|0.73|0.98
72580841|NCT02028676|144691363|SUPERIORITY_OR_OTHER|||||||0.44|||||||Log Rank|Global test with 2df, adjusted for randomization stratification factors||||||0.44
72580842|NCT02028676|144691363|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.82||||0.3|TWO_SIDED|95.0|0.55|1.2|||Regression, Cox|Adjusted for randomization stratification factors|Hazard ratio is Arm B vs A|||1.20|0.55|0.30
72580843|NCT02028676|144691363|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.8||||0.24|TWO_SIDED|95.0|0.54|1.17|||Regression, Cox|Adjusted for randomization stratification factors|Hazard ratio is Arm C vs A|||1.17|0.54|0.24
72580844|NCT02028676|144691364|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.1||||0.52|TWO_SIDED|95.0|0.82|1.49|||Log Rank|Adjusted for randomization stratification factors|Hazard ratio is CDM vs LCM.|||1.49|0.82|0.52
72580845|NCT02028676|144691364|SUPERIORITY_OR_OTHER|||||||0.34||||||Global test with 2df, adjusted for randomization stratification factors|Log Rank|||||||0.34
72580846|NCT02028676|144691364|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.78||||0.19|TWO_SIDED|95.0|0.54|1.13|||Regression, Cox|Adjusted for randomization stratification factors|Hazard ratio is Arm B vs A|||1.13|0.54|0.19
72580847|NCT02028676|144691364|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.81||||0.25|TWO_SIDED|95.0|0.56|1.16|||Regression, Cox|Adjusted for randomization stratification factors|Hazard ratio is Arm C vs A|||1.16|0.56|0.25
72580848|NCT02028676|144691365|SUPERIORITY_OR_OTHER|||||||0.71|||||||Generalized estimating equations|Generalised estimating equations with independent correlation structure and robust standard errors, calculated over all post-randomization visit weeks||||||0.71
72580849|NCT02028676|144691365|SUPERIORITY_OR_OTHER|||||||0.58|||||||Generalized estimating equations|Generalised estimating equations with independent correlation structure and robust standard errors, calculated over all post-randomization visit weeks||||||0.58
72580850|NCT02028676|144691366|SUPERIORITY_OR_OTHER|||||||0.07|||||||Generalized estimating equations|Generalised estimating equations with independent correlation structure and robust standard errors, calculated over all post-randomization visit weeks||||||0.07
72580851|NCT02028676|144691366|SUPERIORITY_OR_OTHER|||||||0.9|||||||Generalized estimating equations|Generalised estimating equations with independent correlation structure and robust standard errors, calculated over all post-randomization visit weeks||||||0.90
72580852|NCT02028676|144691367|SUPERIORITY_OR_OTHER|||||||0.64|||||||Generalized estimating equations|Generalised estimating equations with independent correlation structure and robust standard errors, calculated over all post-randomization visit weeks||||||0.64
72580853|NCT02028676|144691367|SUPERIORITY_OR_OTHER|||||||0.3|||||||Generalized estimating equations|Generalised estimating equations with independent correlation structure and robust standard errors, calculated over all post-randomization visit weeks||||||0.30
72580854|NCT02028676|144691368|SUPERIORITY_OR_OTHER|||||||0.45|||||||Regression, Linear|Adjusted for randomization stratification factors||||||0.45
72580855|NCT02028676|144691369|SUPERIORITY_OR_OTHER|||||||0.7|||||||Regression, Linear|Adjusted for randomization stratification factors||||||0.70
72580856|NCT02028676|144691370|SUPERIORITY_OR_OTHER|||||||0.59||0.0|||||Regression, Linear|Adjusted for randomization stratification factors||||||0.59
72580857|NCT02028676|144691370|SUPERIORITY_OR_OTHER|||||||0.01|||||||Regression, Linear|Global test with 2df, adjusted for randomization stratification factors||||||0.01
72580858|NCT02028676|144691371|SUPERIORITY_OR_OTHER|||||||0.81|||||||Regression, Linear|Adjusted for randomization stratification factors||||||0.81
72580859|NCT02028676|144691371|SUPERIORITY_OR_OTHER|||||||0.03|||||||Regression, Linear|Global test with 2df, adjusted for randomization stratification factors||||||0.03
72580860|NCT02028676|144691372|SUPERIORITY_OR_OTHER|||||||0.86|||||||Chi-squared|||||||0.86
72580861|NCT02028676|144691372|SUPERIORITY_OR_OTHER|||||||0.02|||||||Chi-squared|||||||0.02
72580862|NCT02028676|144691373|SUPERIORITY_OR_OTHER|||||||0.2|||||||Chi-squared|||||||0.20
72580863|NCT02028676|144691373|SUPERIORITY_OR_OTHER|||||||0.002|||||||Chi-squared|||||||0.002
72580864|NCT02028676|144691374|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.78||||0.22|TWO_SIDED|95.0|0.48|1.29|||Log Rank|Adjusted for randomization stratification factors|Hazard ratio is CDM vs LCM|||1.29|0.48|0.22
72580865|NCT02028676|144691375|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.672||||0.09|TWO_SIDED|95.0|0.42|1.075|||Log Rank||Hazard ratio is CDM vs LCM|||1.075|0.420|0.09
72580866|NCT02028676|144691375|SUPERIORITY_OR_OTHER|||||||0.04|||||||Log Rank|Global test with 2df, adjusted for randomization stratification factors||||||0.04
72580867|NCT02028676|144691375|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.16||||0.017|TWO_SIDED|95.0|1.15|4.08|||Regression, Cox|Adjusted for randomization stratification factors|Hazard ratio is Arm B vs A|||4.08|1.15|0.017
72546778|NCT00384033|144622751|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.1||||0.177|TWO_SIDED|95.0|-1.4|7.7||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|ANCOVA|||For DVS SR 50 mg, stomach pain score was evaluated using ANCOVA with treatment and site as factors and baseline stomach pain score as the covariate.||7.70|-1.40|0.177
72546779|NCT00384033|144622751|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.6||||0.048|TWO_SIDED|95.0|0.1|9.1||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|ANCOVA|||For DVS SR 100 mg, stomach pain score was evaluated using ANCOVA with treatment and site as factors and baseline stomach pain score as the covariate.||9.10|0.10|0.048
72546780|NCT00384033|144622751|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.8||||0.088|TWO_SIDED|95.0|-0.5|8.1||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|ANCOVA|||For Duloxetine 60 mg, stomach pain score was evaluated using ANCOVA with treatment and site as factors and baseline stomach pain score as the covariate.||8.10|-0.50|0.088
72546781|NCT00384033|144622751|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.7||||0.122|TWO_SIDED|95.0|-1.0|8.4||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|ANCOVA|||For DVS SR 50 mg, back pain score was evaluated using ANCOVA with treatment and site as factors and baseline back pain score as the covariate.||8.40|-1.00|0.122
72546782|NCT00384033|144622751|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.8||||0.015|TWO_SIDED|95.0|1.1|10.5||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|ANCOVA|||For DVS SR 100 mg, back pain score was evaluated using ANCOVA with treatment and site as factors and baseline back pain score as the covariate.||10.50|1.10|0.015
72580868|NCT02028676|144691375|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.0||||0.034|TWO_SIDED|95.0|1.05|3.8|||Regression, Cox|Adjusted for randomization stratification factors|Hazard ratio is Arm C vs A|||3.80|1.05|0.034
72546783|NCT00384033|144622751|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.2||||0.103|TWO_SIDED|95.0|-0.8|9.2||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|ANCOVA|||For Duloxetine 60 mg, back pain score was evaluated using ANCOVA with treatment and site as factors and baseline back pain score as the covariate.||9.20|-0.80|0.103
72546784|NCT00384033|144622751|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.4||||0.384|TWO_SIDED|95.0|-1.7|4.5||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|ANCOVA|||For DVS SR 50 mg, chest pain score was evaluated using ANCOVA with treatment and site as factors and baseline chest pain score as the covariate.||4.50|-1.70|0.384
72546785|NCT00384033|144622751|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.0||||0.221|TWO_SIDED|95.0|-1.2|5.1||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|ANCOVA|||For DVS SR 100 mg, chest pain score was evaluated using ANCOVA with treatment and site as factors and baseline chest pain score as the covariate.||5.10|-1.20|0.221
72546786|NCT00384033|144622751|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.4||||0.411|TWO_SIDED|95.0|-1.9|4.7||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|ANCOVA|||For Duloxetine 60 mg, chest pain score was evaluated using ANCOVA with treatment and site as factors and baseline chest pain score as the covariate.||4.70|-1.90|0.411
72546787|NCT00384033|144622751|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.0||||0.412|TWO_SIDED|95.0|-2.8|6.7||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|ANCOVA|||For DVS SR 50 mg, arms, legs, joint pain score was evaluated using ANCOVA with treatment and site as factors and baseline arms, legs, pain score as the covariate.||6.70|-2.80|0.412
72546788|NCT00384033|144622751|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.9||||0.042|TWO_SIDED|95.0|0.2|9.6||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|ANCOVA|||For DVS SR 100 mg, arms, legs, joint pain score was evaluated using ANCOVA with treatment and site as factors and baseline arms, legs, pain score as the covariate.||9.60|0.20|0.042
72546789|NCT00384033|144622751|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.3||||0.155|TWO_SIDED|95.0|-1.2|7.8||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|ANCOVA|||For Duloxetine 60 mg, arms, legs, joint pain score was evaluated using ANCOVA with treatment and site as factors and baseline arms, legs, pain score as the covariate.||7.80|-1.20|0.155
72546790|NCT00290745|144622752|OTHER|||||||0.07|||||||Wilcoxon (Mann-Whitney)|||Change in Tumor volume between baseline and Month 6||||0.07
72580869|NCT02028676|144691376|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.3||||0.04|TWO_SIDED|95.0|1.02|1.66|||Log Rank|Adjusted for randomization stratification factors|Hazard ratio is CDM vs LCM|||1.66|1.02|0.04
72546791|NCT00290745|144622753|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Change in Tumor volume between baseline and Month 6||||<0.001
72546792|NCT00290745|144622756|OTHER|||||||0.538|||||||Kruskal-Wallis|||||||0.538
72546793|NCT00290745|144622757|OTHER|||||||0.02|||||||Kruskal-Wallis|||||||0.02
72546794|NCT00290745|144622758|OTHER|||||||0.714|||||||Kruskal-Wallis|||||||0.714
72546795|NCT00290745|144622759|OTHER|||||||0.001|||||||Kruskal-Wallis|||||||0.001
72546796|NCT00290745|144622760|OTHER|||||||0.906|||||||Kruskal-Wallis|||||||0.906
72546797|NCT02750306|144622761|SUPERIORITY||Difference in Least Squares Means|28.2||||0.00128|TWO_SIDED|95.0|11.1|45.2|||ANCOVA|||||45.2|11.1|0.00128
72546798|NCT02750306|144622764|SUPERIORITY||Difference in Least Squares Means|-15.7||||0.01354|TWO_SIDED|95.0|-28.1|-3.3|||ANCOVA|||||-3.3|-28.1|0.01354
72546799|NCT01325207|144622849|OTHER||||||||||||||||||The Maximum Tolerated Dose (MTD) was determined to be 80mg IT every two weeks. This is based on no DLTs being seeing in Cohorts 1-4 with lower doses and 1 DLT out of 7 patients observed at 80mg IT in Cohort 5.|||
72546800|NCT00745251|144622905|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.86|STANDARD_ERROR_OF_MEAN|5.95||0.0084|ONE_SIDED|95.0||-4.84|||ANCOVA|||||-4.84||0.0084
72546801|NCT00745251|144622906|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.05|STANDARD_ERROR_OF_MEAN|1.64||0.0006|TWO_SIDED|95.0|-9.37|-2.74|||ANCOVA|||||-2.74|-9.37|0.0006
72546802|NCT01618305|144622908|SUPERIORITY|P-value was calculated using a Cochran-Mantel-Haenszel test, stratified by gestational age at entry (20-\<28 weeks; 28-\<31 weeks; 31-\<34 weeks; 34-\<37 weeks)||||||0.001|||||||Cochran-Mantel-Haenszel|||||||0.001
72546803|NCT01618305|144622909|SUPERIORITY|||||||0.557|||||||Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by gestational age at entry (20-\<28 weeks; 28-\<31 weeks; 31-\<34 weeks; 34-\<37 weeks)||||||0.557
72546804|NCT01618305|144622910|SUPERIORITY|||||||0.909|||||||Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by gestational age at entry (20-\<28 weeks; 28-\<31 weeks; 31-\<34 weeks; 34-\<37 weeks).||||||0.909
72546805|NCT01618305|144622911|SUPERIORITY|||||||0.938|||||||Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by maternal gestational age at entry (20-\<28 weeks; 28-\<31 weeks; 31-\<34 weeks; 34-\<37 weeks).||||||0.938
72546806|NCT01618305|144622912|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by gestational age at entry (20-\<28 weeks; 28-\<31 weeks; 31-\<34 weeks; 34-\<37 weeks).||||||<0.001
72546807|NCT01618305|144622913|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by gestational age at entry (20-\<28 weeks; 28-\<31 weeks; 31-\<34 weeks; 34-\<37 weeks).||||||<0.001
72546808|NCT01618305|144622918|SUPERIORITY|||||||0.623|||||||Fisher Exact|||||||0.623
72546809|NCT01618305|144622919|SUPERIORITY|||||||0.63|||||||Fisher Exact|||||||.63
72546810|NCT01618305|144622920|SUPERIORITY|||||||0.54|||||||Fisher Exact|||||||.54
72546811|NCT01618305|144622921|SUPERIORITY||||||>|0.99|||||||Fisher Exact|||||||>0.99
72546812|NCT01618305|144622922|SUPERIORITY||||||>|0.99|||||||Fisher Exact|||||||>0.99
72546813|NCT01618305|144622923|SUPERIORITY|||||||0.064|||||||Fisher Exact|||The proportion of HIV-infected infants among those who had a determinable HIV-infection status was compared between arms.||||0.064
72546814|NCT02708277|144622926|SUPERIORITY_OR_OTHER|||||||0.009|||||||Chi-squared|||||||0.009
72546815|NCT02708277|144622927|SUPERIORITY_OR_OTHER|||||||0.303|||||||Chi-squared|||||||0.303
72546816|NCT02708277|144622928|SUPERIORITY_OR_OTHER|||||||0.606|||||||t-test, 2 sided|||||||0.606
72546817|NCT02708277|144622929|SUPERIORITY_OR_OTHER|||||||0.05|||||||Chi-squared|||||||0.05
72546818|NCT05188521|144622965|SUPERIORITY|||||||0.002|||||||Wilcoxon (Mann-Whitney)|||||||0.002
72546819|NCT05188521|144622966|SUPERIORITY|||||||0.593|||||||Wilcoxon (Mann-Whitney)|||||||0.593
72546820|NCT05188521|144622967|SUPERIORITY|||||||0.002|||||||Wilcoxon (Mann-Whitney)|||||||0.002
72546821|NCT05188521|144622968|SUPERIORITY|||||||0.138|||||||Wilcoxon (Mann-Whitney)|||||||0.138
72546822|NCT05188521|144622969|SUPERIORITY|||||||0.003|||||||Wilcoxon (Mann-Whitney)|||||||0.003
72546823|NCT05188521|144622970|SUPERIORITY|||||||0.357|||||||Wilcoxon (Mann-Whitney)|||||||0.357
72546824|NCT05188521|144622971|SUPERIORITY|||||||0.008|||||||Wilcoxon (Mann-Whitney)|||||||0.008
72546825|NCT05188521|144622972|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||||||1.000
72546826|NCT01341639|144622975|NON_INFERIORITY|If the lower bound of the 95% CI was greater than -10% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate.|Difference in percentages|11.37|||<|0.001|TWO_SIDED|95.0|8.44|14.68||1-sided|Miettinen & Nurminen||If the lower bound of the 95% CI was greater than -10% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate.|Difference in percentages: Non-inferiority for PRP|PR5I minus INFANRIX™ hexa|14.68|8.44|< 0.001
72546827|NCT01341639|144622975|NON_INFERIORITY|If the lower bound of the 95% CI was greater than -10% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate.|Difference in percentages|0.0|||<|0.001|TWO_SIDED|95.0|-0.95|0.96||1-sided|Miettinen & Nurminen||If the lower bound of the 95% CI was greater than -10% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate.|Difference in percentages: Non-inferiority for Diphtheria|PR5I minus INFANRIX™ hexa|0.96|-0.95|< 0.001
72546828|NCT01341639|144622975|NON_INFERIORITY|If the lower bound of the 95% CI was greater than -5% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate.|Difference in percentages|0.0|||<|0.001|TWO_SIDED|95.0|-0.71|0.74|||Miettinen & Nurminen||If the lower bound of the 95% CI was greater than -5% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate.|Difference in percentages: Non-inferiority for Tetanus|PR5I minus INFANRIX™ hexa|0.74|-0.71|< 0.001
72546829|NCT01341639|144622975|NON_INFERIORITY|If the lower bound of the 95% CI was greater than -5% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate.|Difference in percentages|0.19|||<|0.001|TWO_SIDED|95.0|-0.51|1.07||1-sided|Miettinen & Nurminen||If the lower bound of the 95% CI was greater than -5% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate.|Difference in percentages: Non-inferiority for IPV1|PR5I minus INFANRIX™ hexa|1.07|-0.51|< 0.001
72546830|NCT01341639|144622975|NON_INFERIORITY|If the lower bound of the 95% CI was greater than -5% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate.|Difference in percentages|0.19|||<|0.001|TWO_SIDED|95.0|-0.69|1.21||1-sided|Miettinen & Nurminen||If the lower bound of the 95% CI was greater than -5% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate.|Difference in percentages: Non-inferiority for IPV2|PR5I minus INFANRIX™ hexa|1.21|-0.69|< 0.001
72546831|NCT01341639|144622975|NON_INFERIORITY|If the lower bound of the 95% CI was greater than -5% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate.|Difference in percentages|0.0|||<|0.001|TWO_SIDED|95.0|-0.7|0.73||1-sided|Miettinen & Nurminen||If the lower bound of the 95% CI was greater than -5% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate.|Difference in percentages: Non-inferiority for IPV3|PR5I minus INFANRIX™ hexa|0.73|-0.7|< 0.001
72546832|NCT01341639|144622976|NON_INFERIORITY|If the lower bound of the 95% CI was greater than -10% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate.|Difference in percentages|0.58|||<|0.001|TWO_SIDED|95.0|-0.49|1.85||1-sided|Miettinen & Nurminen||If the lower bound of the 95% CI was greater than -10% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate.|Difference in percentages: Non-inferiority for HBsAg|PR5I minus INFANRIX™ hexa|1.85|-0.49|< 0.001
72546833|NCT01341639|144622976|NON_INFERIORITY|If the lower bound of the 95% CI was greater than -10% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate.|Difference in percentages|1.33|||<|0.001|TWO_SIDED|95.0|0.32|2.86||1-sided|Miettinen & Nurminen||If the lower bound of the 95% CI was greater than -10% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate.|Difference in percentages: Non-inferiority for PT|PR5I minus INFANRIX™ hexa|2.86|0.32|< 0.001
72546834|NCT01341639|144622976|NON_INFERIORITY|If the lower bound of the 95% CI was greater than -10% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate.|Difference in percentages|-2.59|||<|0.001|TWO_SIDED|95.0|-4.39|-1.29||1-sided|Miettinen & Nurminen||If the lower bound of the 95% CI was greater than -10% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate.|Difference in percentages: Non-inferiority for FHA|PR5I minus INFANRIX™ hexa|-1.29|-4.39|< 0.001
72546835|NCT01341639|144622976|NON_INFERIORITY|If the lower bound of the 95% CI was greater than -10% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate.|Difference in percentages|0.03|||<|0.001|TWO_SIDED|95.0|-1.4|1.52||1-sided|Miettinen & Nurminen||If the lower bound of the 95% CI was greater than -10% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate.|Difference in percentages: Non-inferiority for PRN|PR5I minus INFANRIX™ hexa|1.52|-1.4|< 0.001
72546836|NCT01341639|144622978|NON_INFERIORITY|If the lower bound of the 95% CI was greater than -5% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate.|Difference in percentages|-0.26|||<|0.001|TWO_SIDED|95.0|-2.82|2.25||1-sided|Miettinen & Nurminen||If the lower bound of the 95% CI was greater than -5% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate.|Difference in percentages: Non-inferiority for Measles|PR5I minus INFANRIX™ hexa|2.25|-2.82|< 0.001
72580870|NCT02028676|144691376|SUPERIORITY_OR_OTHER|||||||0.53|||||||Log Rank|Global test with 2df, adjusted for randomization stratification factors||||||0.53
72580871|NCT02028676|144691376|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.92||||0.6|TWO_SIDED|95.0|0.68|1.25|||Regression, Cox|Adjusted for randomization stratification factors|Hazard ratio is Arm B vs A|||1.25|0.68|0.60
72580872|NCT02028676|144691376|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.09||||0.56|TWO_SIDED|95.0|0.81|1.46|||Regression, Cox|Adjusted for randomization stratification factors|Hazard ratio is Arm C vs A|||1.46|0.81|0.56
72580873|NCT02028676|144691377|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.95||||0.84|TWO_SIDED|95.0|0.58|1.56|||Log Rank|Adjusted for randomization stratification factors|Hazard ratio is CDM vs LCM|||1.56|0.58|0.84
72412084|NCT02819726|144332216|EQUIVALENCE|The equivalence between 2 study treatments would be declared if the two-sided 95% CI of the difference in change from baseline in DAS28-CRP at week 24 in entirely contained within the equivalence margin of \[-0.6,0.6\]|LS Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.134||0.2402|TWO_SIDED|95.0|-0.422|0.106|||ANCOVA|||Least square means and confidence intervals (CIs) were estimated from an ANCOVA model containing treatment group as a factor and baseline DAS28-CRP value as a covariate. ANCOVA model contains treatment group only||0.106|-0.422|0.2402
72412085|NCT02819726|144332216|EQUIVALENCE|The equivalence between 2 study treatments would be declared if the two-sided 95% CI of the difference in change from baseline in DAS28-CRP at week 24 in entirely contained within the equivalence margin of \[-0.6,0.6\]|LS Means Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.135||0.1346|TWO_SIDED|95.0|-0.469|0.063|||ANCOVA|||Least square means and CIs were estimated from an ANCOVA model containing treatment group as a factor and baseline DAS28-CRP value as a covariate. ANCOVA model contains treatment group only||0.063|-0.469|0.1346
72412086|NCT02819726|144332216|EQUIVALENCE|The equivalence between 2 study treatments would be declared if the two-sided 95% CI of the difference in change from baseline in DAS28-CRP at week 24 in entirely contained within the equivalence margin of \[-0.6,0.6\]|LS Means Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.137||0.7429|TWO_SIDED|95.0|-0.314|0.224|||ANCOVA|||Least square means and CIs were estimated from an ANCOVA model containing treatment group as a factor and baseline DAS28-CRP value as a covariate. ANCOVA model contains treatment group only||0.224|-0.314|0.7429
72412087|NCT02819726|144332225|OTHER||LS Means Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.172||0.6068|TWO_SIDED|95.0|-0.428|0.25|||ANCOVA|||Week 52 (EOS). Least square means and confidence intervals were estimated from an ANCOVA model containing treatment group as a factor and Baseline DAS28-CRP value as a covariate. ANCOVA model contains treatment group only.||0.250|-0.428|0.6068
72412088|NCT02819726|144332225|OTHER||LS Means Difference|0.09|STANDARD_ERROR_OF_MEAN|0.172||0.599|TWO_SIDED|95.0|-0.249|0.43|||ANCOVA|||Week 52 (EOS) Least square means and confidence intervals were estimated from an ANCOVA model containing treatment group as a factor and Baseline DAS28-CRP value as a covariate. ANCOVA model contains treatment group only.||0.430|-0.249|0.5990
72412089|NCT02819726|144332225|OTHER||LS Means Difference|0.18|STANDARD_ERROR_OF_MEAN|0.175||0.3053|TWO_SIDED|95.0|-0.165|0.532|||ANCOVA|||Week 53 (EOS) MabThera vs Rituxan. Least square means and confidence intervals were estimated from an ANCOVA model containing treatment group as a factor and Baseline DAS28-CRP value as a covariate. ANCOVA model contains treatment group only.||0.532|-0.165|0.3053
72412090|NCT02819726|144332226|OTHER||Difference (%)|9.4|STANDARD_ERROR_OF_MEAN|7.22|||TWO_SIDED|95.0|-4.74|23.03||||||Week 52 (EOS) assessment. The 95% CIs for ACR response rate and difference were derived using the Wilson Score method.||23.03|-4.74|
72412091|NCT02819726|144332226|OTHER||Difference (%)|-2.5|STANDARD_ERROR_OF_MEAN|7.05|||TWO_SIDED|95.0|-15.95|11.22||||||Week 52 (EOS) assessment. The 95% CIs for ACR response rate and difference were derived using the Wilson Score method.||11.22|-15.95|
72412092|NCT02819726|144332226|OTHER||Difference (%)|-11.8|STANDARD_ERROR_OF_MEAN|7.26|||TWO_SIDED|95.0|-25.47|2.45||||||Week 52 (EOS) assessment. The 95% CIs for ACR response rate and difference were derived using the Wilson Score method.||2.45|-25.47|
72412093|NCT02819726|144332227|OTHER||Difference (%)|9.5|STANDARD_ERROR_OF_MEAN|6.87|||TWO_SIDED|95.0|-4.07|22.46||||||ACR20 Week 52 (EOS) assessment. The 95% CIs for ACR response rate and difference were derived using the Wilson Score method. The adjusted difference and its 95% confidence intervals are from a logistic regression model containing treatment group as a factor and baseline DAS28-CRP value as a covariate.||22.46|-4.07|
72412094|NCT02819726|144332227|OTHER||Difference (%)|3.5|STANDARD_ERROR_OF_MEAN|7.07|||TWO_SIDED|95.0|-10.22|17.03||||||ACR50 Week 52 (EOS) assessment. The 95% CIs for ACR response rate and difference were derived using the Wilson Score method. The adjusted difference and its 95% confidence intervals are from a logistic regression model containing treatment group as a factor and baseline DAS28-CRP value as a covariate.||17.03|-10.22|
72412095|NCT02819726|144332227|OTHER||Difference (%)|-5.9|STANDARD_ERROR_OF_MEAN|6.88|||TWO_SIDED|95.0|-19.1|7.51||||||ACR50 Week 52 (EOS) assessment. The 95% CIs for ACR response rate and difference were derived using the Wilson Score method. The adjusted difference and its 95% confidence intervals are from a logistic regression model containing treatment group as a factor and baseline DAS28-CRP value as a covariate.||7.51|-19.10|
72580874|NCT02028676|144691377|SUPERIORITY_OR_OTHER|||||||0.002|||||||Log Rank|Global test with 2df, adjusted for randomization stratification factors||||||0.002
72580875|NCT02028676|144691377|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|3.8||||0.001|TWO_SIDED|95.0|1.74|8.29|||Regression, Cox|Adjusted for randomization stratification factors|Hazard ratio is Arm B vs A|||8.29|1.74|0.001
72580876|NCT02028676|144691377|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|3.09||||0.006|TWO_SIDED|95.0|1.39|6.85|||Regression, Cox|Adjusted for randomization stratification factors|Hazard ratio is Arm C vs A|||6.85|1.39|0.006
72580877|NCT02028676|144691378|SUPERIORITY_OR_OTHER|||||||0.53|||||||Generalized estimating equations|Generalised estimating equations with independent correlation structure and robust standard errors, calculated over all post-randomization visit weeks||||||0.53
72580878|NCT02028676|144691378|SUPERIORITY_OR_OTHER|||||||0.46|||||||Generalized estimating equations|Generalised estimating equations with independent correlation structure and robust standard errors, calculated over all post-randomization visit weeks||||||0.46
72580879|NCT02028676|144691379|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-2.3||||0.52|TWO_SIDED|95.0|-9.3|4.7|||Chi-squared|||||4.7|-9.3|0.52
72580880|NCT02028676|144691380|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.4||||0.39|TWO_SIDED|95.0|-1.2|0.5|||Regression, Linear|Adjusted for randomization stratification factors|Difference is once-daily minus twice-daily|||0.5|-1.2|0.39
72546837|NCT01341639|144622978|NON_INFERIORITY|If the lower bound of the 95% CI was greater than -5% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate.|Difference in percentages|3.07|||<|0.001|TWO_SIDED|95.0|-0.12|6.4||1-sided|Miettinen & Nurminen||If the lower bound of the 95% CI was greater than -5% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate.|Difference in percentages: Non-inferiority for Mumps|PR5I minus INFANRIX™ hexa|6.4|-0.12|< 0.001
72546838|NCT01341639|144622978|NON_INFERIORITY|If the lower bound of the 95% CI was greater than -5% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate.|Difference in percentages|0.39|||<|0.001|TWO_SIDED|95.0|-1.5|2.34||1-sided|Miettinen & Nurminen||If the lower bound of the 95% CI was greater than -5% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate.|Difference in percentages: Non-inferiority for Rubella|PR5I minus INFANRIX™ hexa|2.34|-1.5|< 0.001
72546839|NCT01341639|144622978|NON_INFERIORITY|If the lower bound of the 95% CI was greater than -10% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate.|Difference in percentages|-0.02|||<|0.001|TWO_SIDED|95.0|-2.11|2.06||1-sided|Miettinen & Nurminen||If the lower bound of the 95% CI was greater than -10% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate.|Difference in percentages: Non-inferiority for Varicella|PR5I minus INFANRIX™ hexa|2.06|-2.11|< 0.001
72546840|NCT01341639|144622979|OTHER|Miettinen \& Nurminen method|Risk Difference (RD)|-0.7|||||TWO_SIDED|95.0|-1.9|0.4|||||If the 95% CI for the risk differences included 0.0, the numerical differences were not considered significant.|Risk difference: ISRs or systemic AEs|PR5I minus INFANRIX™ hexa|0.4|-1.9|
72546841|NCT01341639|144622979|OTHER|Miettinen \& Nurminen method|Risk Difference (RD)|-0.3|||||TWO_SIDED|95.0|-1.8|1.1|||||If the 95% CI for the risk differences included 0.0, the numerical differences were not considered significant.|Risk difference: ISRs or vaccine-related systemic AEs|PR5I minus INFANRIX™ hexa|1.1|-1.8|
72546842|NCT01341639|144622979|OTHER|Miettinen \& Nurminen method|Risk Difference (RD)|1.1|||||TWO_SIDED|95.0|-2.1|4.3|||||If the 95% CI for the risk differences included 0.0, the numerical differences were not considered significant.|Risk difference: At least 1 ISR|PR5I minus INFANRIX™ hexa|4.3|-2.1|
72546843|NCT01341639|144622979|OTHER|Miettinen \& Nurminen method|Risk Difference (RD)|0.9|||||TWO_SIDED|95.0|-2.4|4.3|||||If the 95% CI for the risk differences included 0.0, the numerical differences were not considered significant.|Risk difference: At least 1 solicited ISR|PR5I minus INFANRIX™ hexa|4.3|-2.4|
72546844|NCT01341639|144622979|OTHER|Miettinen \& Nurminen method|Risk Difference (RD)|-1.0|||||TWO_SIDED|95.0|-2.4|0.3|||||If the 95% CI for the risk differences included 0.0, the numerical differences were not considered significant.|Risk difference: At least 1 systemic AE|PR5I minus INFANRIX™ hexa|0.3|-2.4|
72546845|NCT01341639|144622979|OTHER|Miettinen \& Nurminen method|Risk Difference (RD)|-0.9|||||TWO_SIDED|95.0|-3.2|1.3|||||If the 95% CI for the risk differences included 0.0, the numerical differences were not considered significant.|Risk difference: At least 1 vaccine-related systemic AE|PR5I minus INFANRIX™ hexa|1.3|-3.2|
72546846|NCT01341639|144622979|OTHER|Miettinen \& Nurminen method|Risk Difference (RD)|-1.5|||||TWO_SIDED|95.0|-3.3|0.2|||||If the 95% CI for the risk differences included 0.0, the numerical differences were not considered significant.|Risk difference: At least 1 solicited systemic AE|PR5I minus INFANRIX™ hexa|0.2|-3.3|
72546847|NCT01341639|144622979|OTHER|Miettinen \& Nurminen method|Risk Difference (RD)|-1.3|||||TWO_SIDED|95.0|-3.7|1.1|||||If the 95% CI for the risk differences included 0.0, the numerical differences were not considered significant.|Risk difference: At least 1 vaccine-related solicited systemic AE|PR5I minus INFANRIX™ hexa|1.1|-3.7|
72546848|NCT01341639|144622980|OTHER|Miettinen \& Nurminen method|Risk Difference (RD)|4.8|||||TWO_SIDED|95.0|-0.5|10.1|||||If the 95% CI for the risk differences included 0.0, the numerical differences were not considered significant.|Risk difference: Injection-site erythema|PR5I minus INFANRIX™ hexa|10.1|-0.5|
72546849|NCT01341639|144622980|OTHER|Miettinen \& Nurminen method|Risk Difference (RD)|1.8|||||TWO_SIDED|95.0|-3.2|6.8|||||If the 95% CI for the risk differences included 0.0, the numerical differences were not considered significant.|Risk difference: Injection-site pain|PR5I minus INFANRIX™ hexa|6.8|-3.2|
72546850|NCT01341639|144622980|OTHER|Miettinen \& Nurminen method|Risk Difference (RD)|4.0|||||TWO_SIDED|95.0|-1.6|9.6|||||If the 95% CI for the risk differences included 0.0, the numerical differences were not considered significant.|Risk difference: Injection-site swelling|PR5I minus INFANRIX™ hexa|9.6|-1.6|
72546851|NCT01341639|144622981|OTHER|Miettinen \& Nurminen method|Risk Difference (RD)|0.1|||||TWO_SIDED|95.0|-1.8|2.1|||||If the 95% CI for the risk differences included 0.0, the numerical differences were not considered significant.|Risk difference: Injection-site bruising|PR5I minus INFANRIX™ hexa|2.1|-1.8|
72546852|NCT01341639|144622981|OTHER|Miettinen \& Nurminen method|Risk Difference (RD)|0.6|||||TWO_SIDED|95.0|-0.6|2.1|||||If the 95% CI for the risk differences included 0.0, the numerical differences were not considered significant.|Risk difference: Injection-site haematoma|PR5I minus INFANRIX™ hexa|2.1|-0.6|
72580881|NCT02028676|144691381|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0||||0.98|TWO_SIDED|95.0|-0.9|0.9|||Regression, Linear|Adjusted for randomization stratification factors|Difference is once-daily minus twice-daily|||0.9|-0.9|0.98
72580882|NCT02028676|144691382|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.8||||0.12|TWO_SIDED|95.0|-1.9|0.2|||Regression, Linear|Adjusted for randomization stratification factors|Difference is once-daily minus twice-daily|||0.2|-1.9|0.12
72580883|NCT02028676|144691383|SUPERIORITY_OR_OTHER||Mean Difference (Net)|8.0||||0.82|TWO_SIDED|95.0|-60.0|76.0|||Regression, Linear|Adjusted for randomization stratification factors|Difference is once-daily minus twice-daily|||76|-60|0.82
72412096|NCT02819726|144332227|OTHER||Difference (%)|10.0|STANDARD_ERROR_OF_MEAN|5.78|||TWO_SIDED|95.0|-1.52|21.22||||||ACR70 Week 52 (EOS) assessment. The 95% CIs for ACR response rate and difference were derived using the Wilson Score method. The adjusted difference and its 95% confidence intervals are from a logistic regression model containing treatment group as a factor and baseline DAS28-CRP value as a covariate.||21.22|-1.52|
72412097|NCT02819726|144332227|OTHER||Difference|5.4|STANDARD_ERROR_OF_MEAN|6.08|||TWO_SIDED|95.0|-6.69|17.13||||||ACR70 Week 52 (EOS) assessment. The 95% CIs for ACR response rate and difference were derived using the Wilson Score method. The adjusted difference and its 95% confidence intervals are from a logistic regression model containing treatment group as a factor and baseline DAS28-CRP value as a covariate.||17.13|-6.69|
72412098|NCT02819726|144332227|OTHER||Difference (%)|-4.7|STANDARD_ERROR_OF_MEAN|5.58|||TWO_SIDED|92.0|-15.68|6.41||||||ACR70 Week 52 (EOS) assessment. The 95% CIs for ACR response rate and difference were derived using the Wilson Score method. The adjusted difference and its 95% confidence intervals are from a logistic regression model containing treatment group as a factor and baseline DAS28-CRP value as a covariate.||6.41|-15.68|
72580884|NCT02028676|144691384|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-33.0||||0.36|TWO_SIDED|95.0|-104.0|38.0|||Regression, Linear|Adjusted for randomization stratification factors|Difference is once-daily minus twice-daily|||38|-104|0.36
72580885|NCT02028676|144691385|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-87.0||||0.2|TWO_SIDED|95.0|-220.0|46.0|||Regression, Linear|Adjusted for randomization stratification factors|Difference is once-daily minus twice-daily|||46|-220|0.20
72580886|NCT02028676|144691387|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.43||||0.2|TWO_SIDED|95.0|0.11|1.64|||Log Rank||Hazard ratio is once-daily vs twice-daily|||1.64|0.11|0.20
72580887|NCT02028676|144691388|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.75||||0.51|TWO_SIDED|95.0|0.31|1.77|||Log Rank||Hazard ratio is once-daily vs twice-daily|||1.77|0.31|0.51
72580888|NCT02028676|144691389|SUPERIORITY_OR_OTHER|||||||0.16|||||||Generalized estimating equations|Generalised estimating equations with independent correlation structure and robust standard errors, calculated over all post-randomization visit weeks||||||0.16
72580889|NCT02028676|144691390|SUPERIORITY_OR_OTHER|||||||0.54|||||||Generalized estimating equations|Generalised estimating equations with independent correlation structure and robust standard errors, calculated over all post-randomization visit weeks||||||0.54
72580890|NCT02028676|144691391|SUPERIORITY_OR_OTHER|||||||0.08|||||||Generalised estimating equations|Generalised estimating equations with independent correlation structure and robust standard errors, calculated over all post-randomization visit weeks||||||0.08
72580891|NCT02028676|144691392|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.04||||0.82|TWO_SIDED|95.0|0.72|1.52|||Log Rank|Adjusted for randomization stratification factors|Hazard ratio is once-daily vs twice-daily|||1.52|0.72|0.82
72580892|NCT02028676|144691393|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.78||||0.31|TWO_SIDED|95.0|0.48|1.27|||Log Rank|Adjusted for randomization stratification factors|Hazard ratio is once-daily vs twice-daily|||1.27|0.48|0.31
72580893|NCT02028676|144691394|SUPERIORITY_OR_OTHER|||||||0.74|||||||Chi-squared|||||||0.74
72580894|NCT02028676|144691395|SUPERIORITY_OR_OTHER|||||||0.9|||||||Chi-squared|||||||0.90
72580895|NCT02028676|144691396|SUPERIORITY_OR_OTHER|||||||0.93|||||||Generalized estimating equations|Generalised estimating equation with independent correlation structure and robust standard errors, calculated over all post-randomization visit weeks||||||0.93
72580896|NCT02028676|144691397|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.21|||<|0.001|TWO_SIDED|95.0|1.5|3.25|||Log Rank|Adjusted for randomization stratification factors|Hazard ratio is stop vs continue|||3.25|1.50|<0.001
72580897|NCT02028676|144691398|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.47||||0.44|TWO_SIDED|95.0|0.56|3.85|||Log Rank|Adjusted for randomization stratification factors|Hazard ratio is stop vs continue|||3.85|0.56|0.44
72580898|NCT02028676|144691399|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.4||||0.03|TWO_SIDED|95.0|1.05|5.48|||Log Rank|Adjusted for randomization stratification factors|Hazard ratio is stop vs continue|||5.48|1.05|0.03
72580899|NCT02028676|144691400|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|3.98||||0.18|TWO_SIDED|95.0|0.44|35.7|||Log Rank|Adjusted for randomization stratification factors|Hazard ratio is stop vs continue|||35.7|0.44|0.18
72580900|NCT02028676|144691401|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.8||||0.34|TWO_SIDED|95.0|0.53|6.17|||Log Rank|Adjusted for randomization stratification factors|Hazard ratio is stop vs continue|||6.17|0.53|0.34
72580901|NCT02028676|144691402|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.69||||0.68|TWO_SIDED|95.0|0.12|4.15|||Log Rank|Adjusted for randomization stratification factors|Hazard ratio is stop vs continue|||4.15|0.12|0.68
72580902|NCT02028676|144691403|SUPERIORITY_OR_OTHER|||||||0.07|||||||Generalised estimating equations|Generalised estimating equations with independent correlation structure and robust standard errors, calculated over all post-randomization visit weeks||||||0.07
72580903|NCT02028676|144691404|SUPERIORITY_OR_OTHER|||||||0.19|||||||Generalised estimating equations|Generalised estimating equations with independent correlation structure and robust standard errors, calculated over all post-randomization visit weeks||||||0.19
72580904|NCT02028676|144691405|SUPERIORITY_OR_OTHER|||||||0.34|||||||Generalised estimating equations|Generalised estimating equations with independent correlation structure and robust standard errors, calculated over all post-randomization visit weeks||||||0.34
72580905|NCT02028676|144691406|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.6||||0.13|TWO_SIDED|95.0|-1.4|0.2|||Regression, Linear|Adjusted for randomization stratification factors|Difference is stop minus continue|||0.2|-1.4|0.13
72580906|NCT02028676|144691407|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-11.0||||0.68|TWO_SIDED|95.0|-65.0|42.0|||Regression, Linear|Adjusted for randomization stratification factors|Difference is stop minus continue|||42|-65|0.68
72412099|NCT02819726|144332228|OTHER||LS Means Difference|-1.28|STANDARD_ERROR_OF_MEAN|0.991||0.1997|TWO_SIDED|95.0|-3.23|0.671|||ANCOVA|||Swollen Joint Count (SJC) Week 52 (EOS) assessment. Least square means and confidence intervals were estimated from an ANCOVA model containing treatment group as a factor and baseline value as a covariate.||0.671|-3.230|0.1997
72412100|NCT02819726|144332228|OTHER||LS Means Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.996||0.9098|TWO_SIDED|95.0|-2.074|1.848|||ANCOVA|||Swollen Joint Count (SJC) Week 52 (EOS) assessment. Least square means and confidence intervals were estimated from an ANCOVA model containing treatment group as a factor and baseline value as a covariate.||1.848|-2.074|0.9098
72412101|NCT02819726|144332228|OTHER||LS Means Difference|1.17|STANDARD_ERROR_OF_MEAN|1.008||0.248|TWO_SIDED|95.0|-0.817|3.15|||ANCOVA|||Swollen Joint Count (SJC) Week 52 (EOS) assessment. Least square means and confidence intervals were estimated from an ANCOVA model containing treatment group as a factor and baseline value as a covariate.||3.150|-0.817|0.2480
72546853|NCT01341639|144622981|OTHER|Miettinen \& Nurminen method|Risk Difference (RD)|-0.7|||||TWO_SIDED|95.0|-2.3|0.8|||||If the 95% CI for the risk differences included 0.0, the numerical differences were not considered significant.|Risk difference: Injection-site haemorrhage|PR5I minus INFANRIX™ hexa|0.8|-2.3|
72546854|NCT01341639|144622981|OTHER|Miettinen \& Nurminen method|Risk Difference (RD)|-3.7|||||TWO_SIDED|95.0|-7.8|0.5|||||If the 95% CI for the risk differences included 0.0, the numerical differences were not considered significant.|Risk difference: Injection-site induration|PR5I minus INFANRIX™ hexa|0.5|-7.8|
72546855|NCT01341639|144622981|OTHER|Miettinen \& Nurminen method|Risk Difference (RD)|-0.2|||||TWO_SIDED|95.0|-1.7|1.3|||||If the 95% CI for the risk differences included 0.0, the numerical differences were not considered significant.|Risk difference: Injection-site nodule|PR5I minus INFANRIX™ hexa|1.3|-1.7|
72546856|NCT01341639|144622981|OTHER|Miettinen \& Nurminen method|Risk Difference (RD)|1.1||||||95.0|-0.6|3.0|||||If the 95% CI for the risk differences included 0.0, the numerical differences were not considered significant.|Risk difference: Injection-site warmth|PR5I minus INFANRIX™ hexa|3|-0.6|
72546857|NCT01341639|144622982|OTHER|Miettinen \& Nurminen method.|Risk Difference (RD)|-2.5|||||TWO_SIDED|95.0|-6.3|1.4|||||If the 95% CI for the risk differences included 0.0, the numerical differences were not considered significant.|Risk difference: Crying|PR5I minus INFANRIX™ hexa|1.4|-6.3|
72546858|NCT01341639|144622982|OTHER|Miettinen \& Nurminen method|Risk Difference (RD)|-3.1|||||TWO_SIDED|95.0|-8.4|2.3|||||If the 95% CI for the risk differences included 0.0, the numerical differences were not considered significant.|Risk difference: Decreased appetite|PR5I minus INFANRIX™ hexa|2.3|-8.4|
72546859|NCT01341639|144622982|OTHER|Miettinen \& Nurminen method|Risk Difference (RD)|2.1|||||TWO_SIDED|95.0|-1.7|6.0|||||If the 95% CI for the risk differences included 0.0, the numerical differences were not considered significant.|Risk difference: Irritability|PR5I minus INFANRIX™ hexa|6|-1.7|
72546860|NCT01341639|144622982|OTHER|Miettinen \& Nurminen method|Risk Difference (RD)|-1.7|||||TWO_SIDED|95.0|-6.7|3.4|||||If the 95% CI for the risk differences included 0.0, the numerical differences were not considered significant.|Risk difference: Pyrexia|PR5I minus INFANRIX™ hexa|3.4|-6.7|
72546861|NCT01341639|144622982|OTHER|Miettinen \& Nurminen method|Risk Difference (RD)|-3.2|||||TWO_SIDED|95.0|-7.8|1.4|||||If the 95% CI for the risk differences included 0.0, the numerical differences were not considered significant.|Risk difference: Somnolence|PR5I minus INFANRIX™ hexa|1.4|-7.8|
72546862|NCT01341639|144622982|OTHER|Miettinen \& Nurminen method|Risk Difference (RD)|0.8|||||TWO_SIDED|95.0|-4.4|6.0|||||If the 95% CI for the risk differences included 0.0, the numerical differences were not considered significant.|Risk difference: Vomiting|PR5I minus INFANRIX™ hexa|6|-4.4|
72546863|NCT01132118|144623015|SUPERIORITY_OR_OTHER|||||||0.93||||||Unadjusted|Wilcoxon (Mann-Whitney)|||The P-value calculated was for the difference betweeen the change during hydroxychloroquine versus placebo using Wilcoxon signed-rank tests.||||0.930
72546864|NCT01132118|144623015|SUPERIORITY_OR_OTHER|||||||0.785||||||Adjusted for weight change.|Regression, Linear|||The P-value was calculated for the difference between the change during hydroxychloroquine versus placebo from a linear regression model.||||0.785
72546865|NCT01132118|144623016|SUPERIORITY_OR_OTHER|||||||0.575||||||Unadjusted P-value|Wilcoxon (Mann-Whitney)|||P-value for the difference between change during hydroxychloroquine versus placebo using Wilcoxon signed-rank tests.||||0.575
72546866|NCT01132118|144623016|SUPERIORITY_OR_OTHER|||||||0.308||||||Adjusted for weight change.|Regression, Linear|||P-value for the difference between the change during hydroxychloroquine versus placebo from a linear regression model.||||0.308
72546867|NCT01132118|144623017|SUPERIORITY_OR_OTHER|||||||0.468||||||Unadjusted|Wilcoxon (Mann-Whitney)|||P-value for the difference betweeen change during hydroxychloroquine versus placebo suing Wilcoxon signed-rank tests.||||0.468
72546868|NCT01132118|144623017|SUPERIORITY_OR_OTHER|||||||0.902||||||Adjusted for weight change.|Regression, Linear|||P-value for the difference between the change during hydroxychloroquine versus placebo from a linear regression model.||||0.902
72546869|NCT01132118|144623018|SUPERIORITY_OR_OTHER|||||||0.004||||||Unadjusted|Wilcoxon (Mann-Whitney)|||P-value for the difference between the change during hydroxychloroquine versus placebo using Wilcoxon signed-rank tests.||||0.004
72546870|NCT01132118|144623018|SUPERIORITY_OR_OTHER|||||||0.004||||||Adjusted for weight change.|Regression, Linear|||P-value for the difference between the change during hydroxychloroquine versus placebo from a linear regression model.||||0.004
72546871|NCT01132118|144623019|SUPERIORITY_OR_OTHER|||||||0.009||||||Unadjusted|Wilcoxon (Mann-Whitney)|||P-value for the difference between the change during hydroxychloroquine versus placebo using Wilcoxon signed-rank tests.||||0.009
72546872|NCT01132118|144623019|SUPERIORITY_OR_OTHER|||||||0.011||||||Adjusted for weight change.|Regression, Linear|||P-value for the difference between the change during hydroxychloroquine versus placebo from a linear regression model.||||0.011
72546873|NCT01132118|144623020|SUPERIORITY_OR_OTHER|||||||0.73||||||Unadjusted|Wilcoxon (Mann-Whitney)|||P-value for the difference between the change during hydroxychloroquine versus placebo using Wilcoxon signed-rank tests.||||0.730
72546874|NCT01132118|144623020|SUPERIORITY_OR_OTHER|||||||0.208||||||Adjusted for weight change.|Regression, Linear|||P-value for the difference between the change during hydroxychloroquine versus placebo from a linear regression model.||||0.208
72546875|NCT01132118|144623021|SUPERIORITY_OR_OTHER|||||||0.487||||||Unadjusted P-value.|Wilcoxon (Mann-Whitney)|||P-value for the difference between the change during hydroxychloroquine versus placebo using Wilcoxon signed-rank tests.||||0.487
72546876|NCT01132118|144623021|SUPERIORITY_OR_OTHER|||||||0.884||||||P-value adjusted for weight change.|Regression, Linear|||P-value for the difference between the change during hydroxycholorquine versus placebo from a linear regression model.||||0.884
72552665|NCT00834756|144636145|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using PROC GLM procedures in SAS, analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Test/Ref Ratio of LS Means x 100|100.37||||||90.0|93.95|107.21|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||107.21|93.95|
72546877|NCT01767597|144623048|SUPERIORITY_OR_OTHER|||||||0.5||||||No p-value adjustments for multiple comparisons were required. Significance was determined using a p-value \<0.05.|Chi-squared|||Power calculations were performed to detect \>15% difference in immediate linkage-to-care and vaccination. We hypothesized from discussions with an expert panel that \~30% of participants would have appropriate care with standard HBV serology. Assuming type 1 error=0.05 and power=80%, 152 participants per arm would be needed. As \~40% of the population would be nonimmunized or HBsAg-positive from previous data, a minimum 375 participants per arm would be required.||||0.5
72546878|NCT02192905|144623090|OTHER|One-sample t-test testing the mean positive problem solving change from baseline to week 8.|Mean Difference (Final Values)|-0.64|STANDARD_DEVIATION|8.31||0.63|TWO_SIDED|95.0|-3.34|2.05|||t-test, 2 sided|||||2.05|-3.34|.63
72546879|NCT02192905|144623091|OTHER|One-sample t-test testing the mean within-person percent weight change from baseline to week 8.|Mean Difference (Final Values)|-0.019|STANDARD_DEVIATION|0.03|<|0.001|TWO_SIDED|95.0|-0.0285|-0.0096|||t-test, 2 sided|||||-.0096|-.0285|<0.001
72546880|NCT02192905|144623092|OTHER|One-sample t-test testing the mean within-person percent weight change from baseline to week 16.|Mean Difference (Final Values)|-0.017|STANDARD_DEVIATION|0.011||0.143|TWO_SIDED|95.0|-0.039|0.006|||t-test, 2 sided|||||.006|-.039|0.143
72546881|NCT02192905|144623093|OTHER|One-sample t-test testing the mean positive problem solving change from baseline to week 16.|Mean Difference (Final Values)|-0.76|STANDARD_DEVIATION|13.07||0.73|TWO_SIDED|95.0|-5.11|3.6|||t-test, 2 sided|||||3.6|-5.11|.73
72546882|NCT02173704|144623094|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Sufficiency: The criterion for a sufficient immune response was that the lower limit of the two-sided 95% CI for the percentage of subjects with hSBA titer ≥1:5 should be ≥ 70%.|Single binomial proportion|100.0|||||TWO_SIDED|95.0|97.2|100.0|||Exact test of binomial proportion|||Statistical analysis 5/99 strain: The power to reject the null hypothesis associated with the primary objective for strain 5/99 was 99%.||100|97.2|
72546883|NCT02173704|144623094|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Sufficiency: The criterion for a sufficient immune response was that the lower limit of the two-sided 95% CI for the percentage of subjects with hSBA titer ≥ 1:5 should be ≥ 70%.|single binomial proportion|79.0|||||TWO_SIDED|95.0|71.4|85.8|||Exact test of binomial proportion|||Statistical analysis NZ98/254 strain: The power to reject the null hypothesis associated with the primary objective for strain NZ98/25 was 94%.||85.8|71.4|
72546884|NCT02173704|144623096|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Sufficiency: The criterion for a sufficient immune response was that the lower limit of the two-sided 95% CI for the percentage of subjects with hSBA titer ≥1:5 should be ≥ 70%.|Single binomial proportion|99.0|||||TWO_SIDED|95.0|95.7|99.98|||Exact test of binomial proportion|||Statistical analysis H44/76 strain: The null hypothesis associated with the primary objective is that the proportion of subjects with hSBA titers ≥ 1:5 one month after the third dose of the Bexsero® vaccine was ≤ 0.70. Assuming the results for the three strains are independent, the power to reject the null hypothesis associated with the primary objectives to demonstrate sufficiency of response (for all three strains was 92%.||99.98|95.7|
72546885|NCT02173704|144623096|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Sufficiency: The criterion for a sufficient immune response was that the lower limit of the two-sided 95% CI for the percentage of subjects with hSBA titer ≥1:5 should be ≥ 75%.|Single binomial proportion|99.0|||||TWO_SIDED|95.0|94.7|99.82|||Exact test for binomial proportion|||Statistical analysis 5/99 strain: The power to reject the null hypothesis associated with the secondary objective for strain 5/99 was 99%.||99.82|94.7|
72552666|NCT02819323|144636146|NON_INFERIORITY|Non-inferiority margin = 10%||||||0.003|||||||Cochran-Mantel-Haenszel|||||||0.003
72552667|NCT02819323|144636146|NON_INFERIORITY|Non-inferiority margin = 10%||||||0.003|||||||Cochran-Mantel-Haenszel|||||||0.003
72552668|NCT02819323|144636146|SUPERIORITY|||||||0.046|||||||Cochran-Mantel-Haenszel|||||||0.046
72552669|NCT02819323|144636146|SUPERIORITY|||||||0.089|||||||Cochran-Mantel-Haenszel|||||||0.089
72552670|NCT02979353|144636148|SUPERIORITY||Risk Ratio (RR)|0.96||||0.017|TWO_SIDED|95.0|||||Mixed Models Analysis|||Statistical Analysis 1 applies to the Hospital Discharge timepoint (average 3 days after study enrollment)||||0.017
72552671|NCT02979353|144636148|SUPERIORITY||Risk Ratio (RR)|0.86|||<|0.0001|TWO_SIDED|95.0|||||Mixed Models Analysis|||Statistical Analysis 2 applies to the Post-Acute Care Discharge time point (occurred on average 31 days after study enrollment)||||<0.0001
72552672|NCT02979353|144636148|SUPERIORITY||Risk Ratio (RR)|0.85|||<|0.0001|TWO_SIDED|95.0|||||Mixed Models Analysis|||Statistical Analysis 3 applies to the 90 Day Follow-Up After PAC Discharge (occurred, on average, 122 days after study enrollment)||||<0.0001
72552673|NCT02979353|144636149|SUPERIORITY||Mean Difference (Net)|-0.28||||0.02|TWO_SIDED|95.0|||||Regression, Linear|||Statistical Analysis 1 applies to the Hospital Discharge time point (occurred, on average, 3 days after study enrollment)||||0.02
72552674|NCT02979353|144636149|SUPERIORITY||Mean Difference (Net)|-0.59|||<|1e-05|TWO_SIDED|95.0|||||Regression, Linear|||Statistical Analysis 2 applies to Post-Acute Care Discharge time point (occurred, on average, 31 days after study enrollment).||||<0.00001
72552675|NCT02979353|144636149|SUPERIORITY||Mean Difference (Net)|-0.35||||0.01|TWO_SIDED|95.0|||||Regression, Linear|||Statistical Analysis 3 applies to 90-Day Follow Up After PAC Discharge time point (occurred, on average, 122 after study enrollment).||||0.01
72552676|NCT03897088|144636157|SUPERIORITY||||||<|1e-05|||||||Cochran-Mantel-Haenszel|||Week 16||||<0.00001
72552677|NCT03897088|144636166|SUPERIORITY||||||<|1e-05|||||||Cochran-Mantel-Haenszel|||Week 16||||<0.00001
72552678|NCT03897088|144636167|SUPERIORITY||||||<|1e-05|||||||Mixed Models Analysis|||Week 16||||<0.00001
72552679|NCT03897088|144636168|SUPERIORITY||||||<|1e-05|||||||Cochran-Mantel-Haenszel|||Week 16||||<0.00001
72552680|NCT03897088|144636169|SUPERIORITY||||||<|1e-05|||||||Cochran-Mantel-Haenszel|||Week 16||||<0.00001
72546886|NCT02173704|144623096|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Sufficiency: The criterion for a sufficient immune response was that the lower limit of the two-sided 95% CI for the percentage of subjects with hSBA titer ≥1:5 should be ≥ 75%.|Single binomial proportion|94.0|||||TWO_SIDED|95.0|88.7|97.4|||Exact test for binomial proportions|||Statistical analysis NZ98/254 strain: The power to reject the null hypothesis associated with the secondary objective for strain NZ98/254 was 99%.||97.4|88.7|
72546887|NCT01617577|144623115|SUPERIORITY_OR_OTHER|||||||0.36||95.0|||||Wilcoxon (Mann-Whitney)|Wilcoxon signed rank test||ADAScog scores at baseline vs final visit (wk 14); null hypothesis is there is no difference between scores||||0.36
72412102|NCT02819726|144332228|OTHER||LS Means Difference|-1.96|STANDARD_ERROR_OF_MEAN|1.5||0.1931|TWO_SIDED|95.0|-4.909|0.996|||ANCOVA|||Tender Joint Count (TJC) Week 52 (EOS) assessment. Least square means and confidence intervals were estimated from an ANCOVA model containing treatment group as a factor and baseline value as a covariate.||0.996|-4.909|0.1931
72412103|NCT02819726|144332228|OTHER||LS Means Difference|-0.77|STANDARD_ERROR_OF_MEAN|1.5||-0.77|TWO_SIDED|95.0|-3.722|2.184|||ANCOVA|||Swollen Joint Count (SJC) Week 52 (EOS) assessment. Least square means and confidence intervals were estimated from an ANCOVA model containing treatment group as a factor and baseline value as a covariate.||2.184|-3.722|-0.77
72546888|NCT01617577|144623115|SUPERIORITY_OR_OTHER|||||||0.058||95.0|||||Wilcoxon (Mann-Whitney)|Wilcoxon signed rank test||PAL(mem) at baseline and 14 wk (final visit): null hypothesis is thereis no difference in score||||0.058
72546889|NCT01617577|144623115|SUPERIORITY_OR_OTHER|||||||0.034||95.0|||||Wilcoxon (Mann-Whitney)|Wilcoxon signed rank test||PALtot trials adj at baseline vs 14wk (final visit)||||0.034
72546890|NCT00729859|144623131|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.02|STANDARD_DEVIATION|0.0075||0.28|TWO_SIDED|95.0|0.005|0.035|||paired t-test|||p value for the difference = 0.28||0.035|0.005|0.28
72546891|NCT01111110|144623141|SUPERIORITY_OR_OTHER_LEGACY||half the mean difference|21.0|STANDARD_ERROR_OF_MEAN|6.7||0.026|TWO_SIDED|95.0|3.8|41.7|||t-test, 2 sided|two sample effect size must be halved to account for mean difference estimates twice the effect size|See 4 Puff result|(Comparison of period 2 minus period 1) results Point and interval estimates are halved because this estimates twice the effect size.||41.7|3.8|0.026
72546892|NCT01111110|144623142|SUPERIORITY_OR_OTHER_LEGACY||half the mean difference|23.5|STANDARD_ERROR_OF_MEAN|6.8||0.018|TWO_SIDED|95.0|6.0|41.0||The effect size is half the difference between the means as (A-B)-(B-A)=2A-2B|t-test, 2 sided|Must take half the mean difference to estimate effect size|No comments|Study intended to get more subjects, but PI's review committee had to deal with candidate deadlines and a high rate of screen failures and allowed her to test seven subjects. Primary concern was the research experience, not the study questions. There was no bias in failing to meet accrual objectives thanks to the blinding.||41.0|6.0|0.018
72546893|NCT01111110|144623143|SUPERIORITY_OR_OTHER_LEGACY||Effect size=half the mean diff|24.7|STANDARD_ERROR_OF_MEAN|6.6||0.013|TWO_SIDED|95.0|7.7|41.7|||t-test, 2 sided||You kicked this out on another trial, but note that the period 2-Period 1 differences between the orderings estimate twice the effect size. The effect sizes herein take this into account.|Null hypothesis is that the Treatment order is independent of the dependent variable based on Period 2 minus Period 1||41.7|7.7|0.013
72546894|NCT03267264|144623269|NON_INFERIORITY|Two-sided 95% confidence intervals is calculated for the average relative rating. A linear model was used to evaluate the pen needle group effect on the response to test whether the groups can be combined (a p-value \< 0.05 for the pen needle group effect indicates non-poolability) and to adjust for the order effect. The order of the pen needles used and the group to which the subject belongs were used as covariates. If the lower bound of the CI is \> -10mm, we can conclude in non-inferiority.|Overall Mean|17.5|||||TWO_SIDED|95.0|10.3|24.7||||||||24.7|10.3|
72546895|NCT03267264|144623270|NON_INFERIORITY|Two-sided 95% confidence intervals is calculated for the average relative rating. A linear model was used to evaluate the pen needle group effect on the response to test whether the groups can be combined (a p-value \< 0.05 for the pen needle group effect indicates non-poolability) and to adjust for the order effect. The order of the pen needles used and the group to which the subject belongs were used as covariates. If the lower bound of the CI is \> -10mm, we can conclude in non-inferiority.|Overall Mean|30.5|||||TWO_SIDED|95.0|16.8|44.3||||||||44.3|16.8|
72546896|NCT03267264|144623270|NON_INFERIORITY|Two-sided 95% confidence intervals is calculated for the average relative rating. A linear model was used to evaluate the pen needle group effect on the response to test whether the groups can be combined (a p-value \< 0.05 for the pen needle group effect indicates non-poolability) and to adjust for the order effect. The order of the pen needles used and the group to which the subject belongs were used as covariates. If the lower bound of the CI is \> -10mm, we can conclude in non-inferiority.|Overall|20.6|||||TWO_SIDED|95.0|4.1|37.1||||||||37.1|4.1|
72546897|NCT03267264|144623270|NON_INFERIORITY|Two-sided 95% confidence intervals is calculated for the average relative rating. A linear model was used to evaluate the pen needle group effect on the response to test whether the groups can be combined (a p-value \< 0.05 for the pen needle group effect indicates non-poolability) and to adjust for the order effect. The order of the pen needles used and the group to which the subject belongs were used as covariates. If the lower bound of the CI is \> -10mm, we can conclude in non-inferiority.|overal mean|6.2|||||TWO_SIDED|95.0|-7.2|19.5||||||||19.5|-7.2|
72546898|NCT03267264|144623270|NON_INFERIORITY|Two-sided 95% confidence intervals is calculated for the average relative rating. A linear model was used to evaluate the pen needle group effect on the response to test whether the groups can be combined (a p-value \< 0.05 for the pen needle group effect indicates non-poolability) and to adjust for the order effect. The order of the pen needles used and the group to which the subject belongs were used as covariates. If the lower bound of the CI is \> -10mm, we can conclude in non-inferiority.|Overall Mean|12.8|||||TWO_SIDED|95.0|-1.1|26.7||||||||26.7|-1.1|
72546899|NCT03267264|144623271|NON_INFERIORITY|Two-sided 95% confidence intervals is calculated for the average relative rating. A linear model was used to evaluate the pen needle group effect on the response to test whether the groups can be combined (a p-value \< 0.05 for the pen needle group effect indicates non-poolability) and to adjust for the order effect. The order of the pen needles used and the group to which the subject belongs were used as covariates. If the lower bound of the CI is \> -10mm, we can conclude in non-inferiority.|Overall mean|18.0|||||TWO_SIDED|95.0|11.3|24.7||||||Overall Comfort||24.7|11.3|
72552681|NCT03897088|144636170|SUPERIORITY||||||<|1e-05|||||||Mixed Models Analysis|||Week 16||||<0.00001
72552682|NCT03897088|144636171|SUPERIORITY||||||<|1e-05||||||Log Rank Test p-Value|Kaplan-Meier Estimates|||||||<0.00001
72546900|NCT03267264|144623271|NON_INFERIORITY|Two-sided 95% confidence intervals is calculated for the average relative rating. A linear model was used to evaluate the pen needle group effect on the response to test whether the groups can be combined (a p-value \< 0.05 for the pen needle group effect indicates non-poolability) and to adjust for the order effect. The order of the pen needles used and the group to which the subject belongs were used as covariates. If the lower bound of the CI is \> -10mm, we can conclude in non-inferiority.|Overall Mean|15.9|||||TWO_SIDED|95.0|9.9|21.8||||||Anxiety Associated with a Needle Stick Injury||21.8|9.9|
72546901|NCT03267264|144623271|NON_INFERIORITY|Two-sided 95% confidence intervals is calculated for the average relative rating. A linear model was used to evaluate the pen needle group effect on the response to test whether the groups can be combined (a p-value \< 0.05 for the pen needle group effect indicates non-poolability) and to adjust for the order effect. The order of the pen needles used and the group to which the subject belongs were used as covariates. If the lower bound of the CI is \> -10mm, we can conclude in non-inferiority.|Overall Mean|15.5|||||TWO_SIDED|95.0|8.9|22.1||||||Injection Pain||22.1|8.9|
72546902|NCT03267264|144623271|NON_INFERIORITY|Two-sided 95% confidence intervals is calculated for the average relative rating. A linear model was used to evaluate the pen needle group effect on the response to test whether the groups can be combined (a p-value \< 0.05 for the pen needle group effect indicates non-poolability) and to adjust for the order effect. The order of the pen needles used and the group to which the subject belongs were used as covariates. If the lower bound of the CI is \> -10mm, we can conclude in non-inferiority.|Overall Mean|19.7|||||TWO_SIDED|95.0|13.8|25.7||||||Ease of Use||25.7|13.8|
72546903|NCT03267264|144623272|NON_INFERIORITY|Two-sided 95% confidence intervals is calculated for the average relative rating. A linear model was used to evaluate the pen needle group effect on the response to test whether the groups can be combined (a p-value \< 0.05 for the pen needle group effect indicates non-poolability) and to adjust for the order effect. The order of the pen needles used and the group to which the subject belongs were used as covariates. If the lower bound of the CI is \> -10mm, we can conclude in non-inferiority.|Overall Mean|27.8|||||TWO_SIDED|95.0|14.9|40.7||||||Overall Comfort||40.7|14.9|
72546904|NCT03267264|144623272|NON_INFERIORITY|Two-sided 95% confidence intervals is calculated for the average relative rating. A linear model was used to evaluate the pen needle group effect on the response to test whether the groups can be combined (a p-value \< 0.05 for the pen needle group effect indicates non-poolability) and to adjust for the order effect. The order of the pen needles used and the group to which the subject belongs were used as covariates. If the lower bound of the CI is \> -10mm, we can conclude in non-inferiority.|Overall Mean|20.2|||||TWO_SIDED|95.0|8.9|31.6||||||Anxiety Associated with a needle stick injury||31.6|8.9|
72546905|NCT03267264|144623272|NON_INFERIORITY|Two-sided 95% confidence intervals is calculated for the average relative rating. A linear model was used to evaluate the pen needle group effect on the response to test whether the groups can be combined (a p-value \< 0.05 for the pen needle group effect indicates non-poolability) and to adjust for the order effect. The order of the pen needles used and the group to which the subject belongs were used as covariates. If the lower bound of the CI is \> -10mm, we can conclude in non-inferiority.|Overall Mean|16.1|||||TWO_SIDED|95.0|3.4|28.8||||||Injection Pain||28.8|3.4|
72546906|NCT03267264|144623272|NON_INFERIORITY|Two-sided 95% confidence intervals is calculated for the average relative rating. A linear model was used to evaluate the pen needle group effect on the response to test whether the groups can be combined (a p-value \< 0.05 for the pen needle group effect indicates non-poolability) and to adjust for the order effect. The order of the pen needles used and the group to which the subject belongs were used as covariates. If the lower bound of the CI is \> -10mm, we can conclude in non-inferiority.|Overall Mean|30.7|||||TWO_SIDED|95.0|19.3|42.1||||||Ease of Use||42.1|19.3|
72546907|NCT03267264|144623272|NON_INFERIORITY|Two-sided 95% confidence intervals is calculated for the average relative rating. A linear model was used to evaluate the pen needle group effect on the response to test whether the groups can be combined (a p-value \< 0.05 for the pen needle group effect indicates non-poolability) and to adjust for the order effect. The order of the pen needles used and the group to which the subject belongs were used as covariates. If the lower bound of the CI is \> -10mm, we can conclude in non-inferiority.|Overall Mean|20.7|||||TWO_SIDED|95.0|5.3|36.1||||||Overall Comfort||36.1|5.3|
72546908|NCT03267264|144623272|NON_INFERIORITY|Two-sided 95% confidence intervals is calculated for the average relative rating. A linear model was used to evaluate the pen needle group effect on the response to test whether the groups can be combined (a p-value \< 0.05 for the pen needle group effect indicates non-poolability) and to adjust for the order effect. The order of the pen needles used and the group to which the subject belongs were used as covariates. If the lower bound of the CI is \> -10mm, we can conclude in non-inferiority.|Overall Mean|19.4|||||TWO_SIDED|95.0|6.0|32.8||||||Anxiety Associated with a needle stick||32.8|6|
72546909|NCT03267264|144623272|NON_INFERIORITY|Two-sided 95% confidence intervals is calculated for the average relative rating. A linear model was used to evaluate the pen needle group effect on the response to test whether the groups can be combined (a p-value \< 0.05 for the pen needle group effect indicates non-poolability) and to adjust for the order effect. The order of the pen needles used and the group to which the subject belongs were used as covariates. If the lower bound of the CI is \> -10mm, we can conclude in non-inferiority.|Overall Mean|18.6|||||TWO_SIDED|95.0|3.6|33.7||||||Injection Pain||33.7|3.6|
72552683|NCT03897088|144636172|SUPERIORITY||||||<|1e-05||||||Log Rank Test p-Value|Kaplan-Meier Estimates|||||||<0.00001
72552684|NCT03897088|144636173|SUPERIORITY||||||<|1e-05|||||||Cochran-Mantel-Haenszel|||||||<0.00001
72552685|NCT03897088|144636174|SUPERIORITY||||||<|1e-05|||||||Cochran-Mantel-Haenszel|||PASI-75||||<0.00001
72552686|NCT03897088|144636174|SUPERIORITY||||||<|1e-05|||||||Cochran-Mantel-Haenszel|||PASI-90||||<0.00001
72552687|NCT03897088|144636174|SUPERIORITY|||||||4e-05|||||||Cochran-Mantel-Haenszel|||PASI-100||||0.00004
72552688|NCT03897088|144636175|SUPERIORITY||||||<|1e-05|||||||Cochran-Mantel-Haenszel|||Week 16||||<0.00001
72552689|NCT03897088|144636176|SUPERIORITY||||||<|1e-05|||||||Mixed Models Analysis|||Week 16||||<0.00001
72552690|NCT03897088|144636177|SUPERIORITY||||||<|1e-05|||||||Cochran-Mantel-Haenszel|||Week 16||||<0.00001
72552691|NCT03897088|144636178|SUPERIORITY||||||<|1e-05||||||Week 16|Cochran-Mantel-Haenszel|||||||<0.00001
72552692|NCT03897088|144636179|SUPERIORITY||||||<|1e-05|||||||Cochran-Mantel-Haenszel|||Week 12||||<0.00001
72552693|NCT03897088|144636180|SUPERIORITY||||||<|1e-05|||||||Cochran-Mantel-Haenszel|||Week 12||||<0.00001
72546910|NCT03267264|144623272|NON_INFERIORITY|Two-sided 95% confidence intervals is calculated for the average relative rating. A linear model was used to evaluate the pen needle group effect on the response to test whether the groups can be combined (a p-value \< 0.05 for the pen needle group effect indicates non-poolability) and to adjust for the order effect. The order of the pen needles used and the group to which the subject belongs were used as covariates. If the lower bound of the CI is \> -10mm, we can conclude in non-inferiority.|Overall Mean|18.4|||||TWO_SIDED|95.0|4.9|31.9||||||Ease of Use||31.9|4.9|
72546911|NCT03267264|144623272|NON_INFERIORITY|Two-sided 95% confidence intervals is calculated for the average relative rating. A linear model was used to evaluate the pen needle group effect on the response to test whether the groups can be combined (a p-value \< 0.05 for the pen needle group effect indicates non-poolability) and to adjust for the order effect. The order of the pen needles used and the group to which the subject belongs were used as covariates. If the lower bound of the CI is \> -10mm, we can conclude in non-inferiority.|Overall Mean|8.4|||||TWO_SIDED|95.0|-4.0|20.9||||||Overall Comfort||20.9|-4.0|
72546912|NCT03267264|144623272|NON_INFERIORITY|Two-sided 95% confidence intervals is calculated for the average relative rating. A linear model was used to evaluate the pen needle group effect on the response to test whether the groups can be combined (a p-value \< 0.05 for the pen needle group effect indicates non-poolability) and to adjust for the order effect. The order of the pen needles used and the group to which the subject belongs were used as covariates. If the lower bound of the CI is \> -10mm, we can conclude in non-inferiority.|Overall Mean|12.9|||||TWO_SIDED|95.0|1.9|23.8||||||Anxiety Associated with a Needle stick injury||23.8|1.9|
72546913|NCT03267264|144623272|NON_INFERIORITY|Two-sided 95% confidence intervals is calculated for the average relative rating. A linear model was used to evaluate the pen needle group effect on the response to test whether the groups can be combined (a p-value \< 0.05 for the pen needle group effect indicates non-poolability) and to adjust for the order effect. The order of the pen needles used and the group to which the subject belongs were used as covariates. If the lower bound of the CI is \> -10mm, we can conclude in non-inferiority.|Overall Mean|7.0|||||TWO_SIDED|95.0|-5.3|19.4||||||Injection Pain||19.4|-5.3|
72546914|NCT03267264|144623272|NON_INFERIORITY|Two-sided 95% confidence intervals is calculated for the average relative rating. A linear model was used to evaluate the pen needle group effect on the response to test whether the groups can be combined (a p-value \< 0.05 for the pen needle group effect indicates non-poolability) and to adjust for the order effect. The order of the pen needles used and the group to which the subject belongs were used as covariates. If the lower bound of the CI is \> -10mm, we can conclude in non-inferiority.|Overall Mean|17.7|||||TWO_SIDED|95.0|6.7|28.8||||||Ease of Use||28.8|6.7|
72546915|NCT03267264|144623272|NON_INFERIORITY|Two-sided 95% confidence intervals is calculated for the average relative rating. A linear model was used to evaluate the pen needle group effect on the response to test whether the groups can be combined (a p-value \< 0.05 for the pen needle group effect indicates non-poolability) and to adjust for the order effect. The order of the pen needles used and the group to which the subject belongs were used as covariates. If the lower bound of the CI is \> -10mm, we can conclude in non-inferiority.|Overall Mean|15.1|||||TWO_SIDED|95.0|2.1|28.1||||||Overall Comfort||28.1|2.1|
72546916|NCT03267264|144623272|NON_INFERIORITY|Two-sided 95% confidence intervals is calculated for the average relative rating. A linear model was used to evaluate the pen needle group effect on the response to test whether the groups can be combined (a p-value \< 0.05 for the pen needle group effect indicates non-poolability) and to adjust for the order effect. The order of the pen needles used and the group to which the subject belongs were used as covariates. If the lower bound of the CI is \> -10mm, we can conclude in non-inferiority.|Overall Mean|11.0|||||TWO_SIDED|95.0|-0.5|22.4||||||Anxiety Associated with a Needle Stick Injury||22.4|-0.5|
72546917|NCT03267264|144623272|NON_INFERIORITY|Two-sided 95% confidence intervals is calculated for the average relative rating. A linear model was used to evaluate the pen needle group effect on the response to test whether the groups can be combined (a p-value \< 0.05 for the pen needle group effect indicates non-poolability) and to adjust for the order effect. The order of the pen needles used and the group to which the subject belongs were used as covariates. If the lower bound of the CI is \> -10mm, we can conclude in non-inferiority.|Overall Mean|20.2|||||TWO_SIDED|95.0|7.4|33.1||||||Injection Pain||33.1|7.4|
72546918|NCT03267264|144623272|NON_INFERIORITY|Two-sided 95% confidence intervals is calculated for the average relative rating. A linear model was used to evaluate the pen needle group effect on the response to test whether the groups can be combined (a p-value \< 0.05 for the pen needle group effect indicates non-poolability) and to adjust for the order effect. The order of the pen needles used and the group to which the subject belongs were used as covariates. If the lower bound of the CI is \> -10mm, we can conclude in non-inferiority.|Overall Mean|12.0|||||TWO_SIDED|95.0|0.5|23.5||||||Eae of Use||23.5|0.5|
72546919|NCT01807871|144623280|SUPERIORITY|||||||0.48|||||||Chi-squared|||||||0.48
72580907|NCT02028676|144691408|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.6||||0.04|TWO_SIDED|95.0|1.02|2.5|||Log Rank|Adjusted for randomization stratification factors|Hazard ratio is stop vs continue|||2.50|1.02|0.04
72580908|NCT02028676|144691409|SUPERIORITY_OR_OTHER|||||||0.21||||||Adjusted for randomization stratification factors|Generalised estimating equation|Generalised estimating equation with independent correlation structure and robust standard errors, calculated over all post-randomization visit weeks||||||0.21
72580909|NCT05287230|144691432|OTHER|||||||0.061||||||A priori threshold for statistical significance is p\<0.05.|ANOVA|||||||0.061
72546920|NCT01807871|144623282|SUPERIORITY|||||||0.24|||||||Chi-squared|||Comparison of number of participants who reported removing the nicotine patch due to a side effect||||0.24
72546921|NCT03019965|144623297|SUPERIORITY||Risk Ratio (RR)|0.95||||0.156|TWO_SIDED|95.0|0.87|1.02|||Chi-squared||||The efficacy of the maneuver was evaluated by calculating the absolute risk reduction and the number needed to treat.|1.02|0.87|0.156
72546922|NCT03019965|144623298|SUPERIORITY||Risk Ratio (RR)|2.98||||0.722|TWO_SIDED|95.0|0.31|28.45|||Chi-squared|||||28.45|0.31|0.722
72546923|NCT01915732|144623299|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.5||||0.002|TWO_SIDED|95.0|-7.4|-1.6|||ANCOVA|||||-1.6|-7.4|0.002
72546924|NCT01915732|144623300|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.6|||<|0.001|TWO_SIDED|95.0|-7.3|-1.9|||ANCOVA|||||-1.9|-7.3|<0.001
72546925|NCT01915732|144623301|SUPERIORITY_OR_OTHER|||||||0.018|||||||Cochran-Mantel-Haenszel|||||||0.018
72546926|NCT01915732|144623302|SUPERIORITY_OR_OTHER|||||||0.013|||||||Cochran-Mantel-Haenszel|||||||0.013
72546927|NCT01915732|144623303|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9||||0.077|TWO_SIDED|95.0|-1.8|0.1|||ANCOVA||Statistical data for the category=IL.|||0.1|-1.8|0.077
72546928|NCT01915732|144623303|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.4||||0.004|TWO_SIDED|95.0|-5.7|-1.1|||ANCOVA||Statistical data for the category=NIL.|||-1.1|-5.7|0.004
72546929|NCT01915732|144623304|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0||||0.028|TWO_SIDED|95.0|-2.0|-0.1|||ANCOVA||Statistical data for the category=IL.|||-0.1|-2.0|0.028
72546930|NCT01915732|144623304|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.4||||0.002|TWO_SIDED|95.0|-5.5|-1.2|||ANCOVA||Statistical data for the category=NIL.|||-1.2|-5.5|0.002
72546931|NCT01915732|144623305|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.03||||0.08|TWO_SIDED|95.0|-0.06|0.0|||ANCOVA||Statistical data for the category=IL.|||0.00|-0.06|0.080
72546932|NCT01915732|144623305|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.07||||0.004|TWO_SIDED|95.0|-0.12|-0.02|||ANCOVA||Statistical data for the category=NIL.|||-0.02|-0.12|0.004
72546933|NCT01915732|144623305|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.05||||0.003|TWO_SIDED|95.0|-0.09|-0.02|||ANCOVA||Statisticial data for the category=Total.|||-0.02|-0.09|0.003
72546934|NCT01915732|144623306|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.04||||0.025|TWO_SIDED|95.0|-0.07|0.0|||ANCOVA||Statistical data for the category=IL.|||-0.00|-0.07|0.025
72546935|NCT01915732|144623306|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.09|||<|0.001|TWO_SIDED|95.0|-0.14|-0.04|||ANCOVA||Statistical data for the category=NIL.|||-0.04|-0.14|<0.001
72546936|NCT01915732|144623306|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.07|||<|0.001|TWO_SIDED|95.0|-0.1|-0.03|||ANCOVA||Statistical data for the category=Total.|||-0.03|-0.10|<0.001
72546937|NCT01915732|144623307|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
72546938|NCT01915732|144623308|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
72546939|NCT01569451|144623311|SUPERIORITY_OR_OTHER|||||||0.0493|||||||Chi-squared|||||||0.0493
72546940|NCT01569451|144623312|SUPERIORITY_OR_OTHER|||||||0.0268|||||||Peto|||||||0.0268
72546941|NCT01569451|144623313|SUPERIORITY_OR_OTHER|||||||0.0189|||||||Chi-squared|||||||0.0189
72546942|NCT01569451|144623314|SUPERIORITY_OR_OTHER|||||||0.3167|||||||Chi-squared|||||||0.3167
72546943|NCT01569451|144623315|SUPERIORITY_OR_OTHER|||||||0.094|||||||Chi-squared|||||||0.0940
72546944|NCT01569451|144623316|SUPERIORITY_OR_OTHER|||||||0.3507|||||||Fisher Exact|||||||0.3507
72546945|NCT01569451|144623317|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||||||1.0000
72546946|NCT01569451|144623318|SUPERIORITY_OR_OTHER|||||||0.4904|||||||t-test, 2 sided|||T-test||||0.4904
72546947|NCT01569451|144623319|SUPERIORITY_OR_OTHER|||||||0.4073|||||||Chi-squared|||||||0.4073
72546948|NCT01569451|144623320|SUPERIORITY_OR_OTHER|||||||0.8677|||||||Mixed Models Analysis|||||||0.8677
72546949|NCT01569451|144623321|OTHER|Mean difference between treatment groups.||||||0.3974|||||||t-test, 2 sided|||||||0.3974
72546950|NCT01166568|144623360|SUPERIORITY||binomial distribution|0.75||||0.025|ONE_SIDED|97.5|0.75|||the p-value is adjusted for multiple comparisons|Fisher Exact|||"The PSI procedure is defined as successful if 75% of subjects achieve the first primary endpoint or second primary endpoint. The corresponding statistical hypotheses are as follows:~H0 (null hypothesis): p1 ≤ 0.75 Ha (alternative hypothesis): p1 \> 0.75, Where, p1 is the probability of subjects achieving the first primary endpoint. H0 (null hypothesis): p2 ≤ 0.75 Ha (alternative hypothesis): p2 \> 0.75, Where, p2 is the probability of subjects achieving the second primary endpoint."|||0.75|0.025
72546951|NCT03335371|144623379|SUPERIORITY||Mean Difference (Final Values)|-0.21|STANDARD_DEVIATION|0.087|<|0.0001|TWO_SIDED|95.0|-0.39|-0.04|||ANCOVA|||||-0.04|-0.39|<0.0001
72546952|NCT01656889|144623460|SUPERIORITY_OR_OTHER|||||||0.5896|TWO_SIDED||||||Cochran-Mantel-Haenszel|P-value is based on the chi-squared proportion of wounds closed in each group.||||||0.5896
72412104|NCT02819726|144332228|OTHER||LS Means Difference|1.19|STANDARD_ERROR_OF_MEAN|1.52||0.4352|TWO_SIDED|95.0|-1.805|4.18|||ANCOVA|||Swollen Joint Count (SJC) Week 52 (EOS) assessment. Least square means and confidence intervals were estimated from an ANCOVA model containing treatment group as a factor and baseline value as a covariate.||4.180|-1.805|0.4352
72546953|NCT01656889|144623461|SUPERIORITY_OR_OTHER|||||||0.3675|TWO_SIDED|0.0|||||Regression, Cox|||||||.3675
72546954|NCT01656889|144623462|SUPERIORITY_OR_OTHER|||||||0.6426|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Treatment Week 01||||0.6426
72546955|NCT01656889|144623462|SUPERIORITY_OR_OTHER|||||||0.3843|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Treatment Week 02||||.3843
72546956|NCT01656889|144623462|SUPERIORITY_OR_OTHER|||||||0.2792|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Treatment Week 03||||0.2792
72546957|NCT01656889|144623462|SUPERIORITY_OR_OTHER|||||||0.1502|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Treatment Week 04||||0.1502
72546958|NCT01656889|144623462|SUPERIORITY_OR_OTHER|||||||0.3823|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Treatment Week 05||||0.3823
72546959|NCT01656889|144623462|SUPERIORITY_OR_OTHER|||||||0.5528|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Treatment Week 06||||0.5528
72546960|NCT01656889|144623462|SUPERIORITY_OR_OTHER|||||||0.02913|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Treatment Week 07||||.02913
72412105|NCT02819726|144332229|OTHER||LS Means Difference|-4.16|STANDARD_ERROR_OF_MEAN|3.242||0.2008|TWO_SIDED|95.0|-10.541|2.226|||ANCOVA|||Week 52 (EOS) Physician's Disease Activity Assessment. Least square means and confidence intervals were estimated from an ANCOVA model containing treatment group as a factor and baseline value as a covariate. Change from Study Day 1 (Baseline)||2.226|-10.541|0.2008
72546961|NCT01656889|144623462|SUPERIORITY_OR_OTHER|||||||0.3896|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Treatment Week 08||||0.3896
72546962|NCT01656889|144623462|SUPERIORITY_OR_OTHER|||||||0.3989|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Treatment Week 09||||0.3989
72412106|NCT02819726|144332229|OTHER||LS Means Difference|-0.39|STANDARD_ERROR_OF_MEAN|3.242||-0.39|TWO_SIDED|95.0|-6.771|5.994|||ANOVA|||Week 52 (EOS) Physician's Disease Activity Assessment. Least square means and confidence intervals were estimated from an ANCOVA model containing treatment group as a factor and baseline value as a covariate. Change from Study Day 1 (Baseline||5.994|-6.771|-0.39
72546963|NCT01656889|144623462|SUPERIORITY_OR_OTHER|||||||0.8682|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Treatment Week 10||||0.8682
72546964|NCT01656889|144623462|SUPERIORITY_OR_OTHER|||||||0.8083|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Treatment Week 11||||0.8083
72546965|NCT01656889|144623462|SUPERIORITY_OR_OTHER|||||||0.6687|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Treatment Week 12||||0.6687
72546966|NCT01656889|144623464|SUPERIORITY_OR_OTHER|||||||0.3601|TWO_SIDED||||||ANCOVA|||Week 01||||0.3601
72546967|NCT01656889|144623464|SUPERIORITY_OR_OTHER|||||||0.9398|TWO_SIDED||||||ANCOVA|||Week 02||||0.9398
72546968|NCT01656889|144623464|SUPERIORITY_OR_OTHER|||||||0.905|TWO_SIDED||||||ANCOVA|||Week 03||||0.905
72546969|NCT01656889|144623464|SUPERIORITY_OR_OTHER|||||||0.4471|TWO_SIDED||||||ANCOVA|||Week 04||||0.4471
72546970|NCT01656889|144623464|SUPERIORITY_OR_OTHER|||||||0.3004|TWO_SIDED||||||ANCOVA|||Week 05||||0.3004
72546971|NCT01656889|144623464|SUPERIORITY_OR_OTHER|||||||0.1815|TWO_SIDED||||||ANCOVA|||Week 06||||0.1815
72546972|NCT01656889|144623464|SUPERIORITY_OR_OTHER|||||||0.399|TWO_SIDED||||||ANCOVA|||Week 07||||0.399
72546973|NCT01656889|144623464|SUPERIORITY_OR_OTHER|||||||0.8027|TWO_SIDED||||||ANCOVA|||Week 08||||0.8027
72546974|NCT01656889|144623464|SUPERIORITY_OR_OTHER|||||||0.4913|TWO_SIDED||||||ANCOVA|||Week 09||||0.4913
72546975|NCT01656889|144623464|SUPERIORITY_OR_OTHER|||||||0.5227|TWO_SIDED||||||ANCOVA|||Week 10||||0.5227
72546976|NCT01656889|144623464|SUPERIORITY_OR_OTHER|||||||0.7032|TWO_SIDED||||||ANCOVA|||Week 11||||0.7032
72546977|NCT01656889|144623464|SUPERIORITY_OR_OTHER|||||||0.9366|TWO_SIDED||||||ANCOVA|||||||0.9366
72546978|NCT01656889|144623465|SUPERIORITY_OR_OTHER|||||||0.9853|TWO_SIDED||||||ANCOVA|||Week 01||||0.9853
72546979|NCT01656889|144623465|SUPERIORITY_OR_OTHER|||||||0.7083|TWO_SIDED||||||ANCOVA|||Week 02||||0.7083
72546980|NCT01656889|144623465|SUPERIORITY_OR_OTHER|||||||0.6744|TWO_SIDED||||||ANCOVA|||Week 03||||0.6744
72546981|NCT01656889|144623465|SUPERIORITY_OR_OTHER|||||||0.2891|TWO_SIDED||||||ANCOVA|||||||0.2891
72546982|NCT01656889|144623465|SUPERIORITY_OR_OTHER|||||||0.9923|TWO_SIDED||||||ANCOVA|||Week 05||||0.9923
72546983|NCT01656889|144623465|SUPERIORITY_OR_OTHER|||||||0.1775|TWO_SIDED||||||ANCOVA|||Week 06||||0.1775
72546984|NCT01656889|144623465|SUPERIORITY_OR_OTHER|||||||0.499|TWO_SIDED||||||ANCOVA|||Week 07||||0.499
72546985|NCT01656889|144623465|SUPERIORITY_OR_OTHER|||||||0.4423|TWO_SIDED||||||ANCOVA|||Week 08||||0.4423
72546986|NCT01656889|144623465|SUPERIORITY_OR_OTHER|||||||0.5138|TWO_SIDED||||||ANCOVA|||Week 09||||0.5138
72546987|NCT01656889|144623465|SUPERIORITY_OR_OTHER|||||||0.3409|TWO_SIDED||||||ANCOVA|||Week 10||||0.3409
72546988|NCT01656889|144623465|SUPERIORITY_OR_OTHER|||||||0.6358|TWO_SIDED||||||ANCOVA|||Week 11||||0.6358
72546989|NCT01656889|144623465|SUPERIORITY_OR_OTHER|||||||0.6753|TWO_SIDED||||||ANCOVA|||Week 12||||0.6753
72546990|NCT01656889|144623466|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Kaplan-Meier Survival analysis|||||||< 0.05
72546991|NCT02114307|144623506|SUPERIORITY|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||||||0.001
72546992|NCT02114307|144623507|SUPERIORITY|||||||0.0023|||||||t-test, 2 sided|||Sham Group - 6 week Time Point - Pre-stimulation versus Post-Stimulation||||0.0023
72546993|NCT02114307|144623507|SUPERIORITY|||||||0.0815|||||||t-test, 2 sided|||Test Group - 6 week Time Point - Pre-stimulation versus Post-Stimulation||||0.0815
72546994|NCT02114307|144623508|SUPERIORITY|||||||0.127|||||||t-test, 1 sided|||||||0.127
72546995|NCT02041702|144623509|SUPERIORITY|The 2-sided 90% confidence interval (CI) was calculated using the Clopper-Pearson method.|Ratio|100.0|||<|0.01|TWO_SIDED|90.0|97.6|100.0|||Clopper-Pearson|Clopper-Pearson CI for the binomial proportion|The null hypothesis would be rejected if the lower bound of the 2-sided 90% confidence interval was greater than 90%.|The hypothesis was: H0: P≤ 90% vs H1: P\>90% P: The proportion of subjects free from MRI scan related complications at 1 month post MRI scan in cardiac MRI scan group||100|97.6|<0.01
72546996|NCT02041702|144623510|NON_INFERIORITY|The 2-sided 90% CI for difference in success rate between 2 groups was calculated by Farrington-Manning method.|Ratio Difference|-0.9||||0.0007|TWO_SIDED|90.0|-5.6|3.8|||Farrington-Manning Test||The null hypothesis would be rejected if the lower bound of the two-sided 90% confidence interval was greater than -10%.|"The hypothesis was: H0: PMRI - PCTRL≤ -10% vs H1: PMRI - PCTRL\>-10%~* PMRI: the success rate in the Cardiac MRI scan group for the change in right atrial capture threshold @0.5ms at 1month post MRI compared to pre-MRI scan value collected at MRI scan visit~* PCTRL: the success rate in the Control group for the change in right atrial capture threshold @0.5ms at 1month post MRI compared to pre-MRI scan value collected at MRI scan visit"||3.8|-5.6|0.0007
72580910|NCT02360215|144691451|SUPERIORITY||Hazard Ratio (HR)|0.76||||0.029|TWO_SIDED|95.0|0.59|0.96|||Gray's test|||Null hypothesis: the addition of HA-WBRT as compared to WBRT will increase time to neurocognitive failure from 53.8% in the WBRT arm to 42.8% in the HA-WBRT arm at 6 months. Treating death as a competing risk and using a Gray's test with two-sided α=0.05 to test for statistically significant difference in the distribution of neurocognitive failure times, it was calculated that 230 events over both arms would provide 90% statistical power.||0.96|0.59|0.029
72580911|NCT02360215|144691452|SUPERIORITY|||||||0.0586|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A mixed effects model was run with HVLT-R Symptom Score (baseline, 2, 4, 6, and 12 months) as the outcome of interest. Age, RPA class, prior radiosurgery, prior surgical resection were the covariates considered in each model along with interaction terms treatment\*time, time\*time, time\*time\*time and remained if p\<0.05. Baseline score, treatment arm, and time were forced into the model. Treatment Arm (WBRT+Memantine vs. HA-WBRT Memantine) is reported here.||||0.0586
72580912|NCT02360215|144691452|SUPERIORITY|||||||0.0048|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A mixed effects model was run with HVLT-R Symptom Score (baseline, 2, 4, 6, and 12 months) as the outcome of interest. Age, RPA class, prior radiosurgery, prior surgical resection were the covariates considered in each model along with interaction terms treatment\*time, time\*time, time\*time\*time and remained if p\<0.05. Baseline score, treatment arm, and time were forced into the model. Age (\>61 year vs. \<= 61 years) is reported here.||||0.0048
72580913|NCT02360215|144691452|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A mixed effects model was run with HVLT-R Symptom Score (baseline, 2, 4, 6, and 12 months) as the outcome of interest. Age, RPA class, prior radiosurgery, prior surgical resection were the covariates considered in each model along with interaction terms treatment\*time, time\*time, time\*time\*time and remained if p\<0.05. Baseline score, treatment arm, and time were forced into the model. Baseline Total Recall is reported here.||||<0.0001
72580914|NCT02360215|144691453|SUPERIORITY|||||||0.2656|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A mixed effects model was run with HVLT-R Delayed Recall Score (baseline, 2, 4, 6, and 12 months) as the outcome of interest. Age, RPA class, prior radiosurgery, prior surgical resection were the covariates considered in each model along with interaction terms treatment\*time, time\*time, time\*time\*time and remained if p\<0.05. Baseline score, treatment arm, and time were forced into the model. Treatment Arm (WBRT+Memantine vs. HA-WBRT Memantine) is reported here.||||0.2656
72580915|NCT02360215|144691453|SUPERIORITY|||||||0.0067|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A mixed effects model was run with HVLT-R Delayed Recall Score (baseline, 2, 4, 6, and 12 months) as the outcome of interest. Age, RPA class, prior radiosurgery, prior surgical resection were the covariates considered in each model along with interaction terms treatment\*time, time\*time, time\*time\*time and remained if p\<0.05. Baseline score, treatment arm, and time were forced into the model. Age (\> 61 years vs. \<= 61 years) is reported here.||||0.0067
72580916|NCT02360215|144691453|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A mixed effects model was run with HVLT-R Delayed Recall Score (baseline, 2, 4, 6, and 12 months) as the outcome of interest. Age, RPA class, prior radiosurgery, prior surgical resection were the covariates considered in each model along with interaction terms treatment\*time, time\*time, time\*time\*time and remained if p\<0.05. Baseline score, treatment arm, and time were forced into the model. Baseline Delayed Recall is reported here.||||<0.0001
72546997|NCT02041702|144623511|NON_INFERIORITY|The 2-sided 90% CI for difference in success rate between 2 groups was calculated by Farrington-Manning method.|Ratio Difference|-1.7||||0.0012|TWO_SIDED|90.0|-6.2|2.8|||Farrington-Manning test||The null hypothesis would be rejected if the lower bound of the two-sided 90% confidence interval was greater than -10%.|"The hypothesis was: H0: PMRI - PCTRL≤ -10% vs H1: PMRI - PCTRL \>-10%~* PMRI: the success rate in the Cardiac MRI Scan Group for change in RV capture threshold value @0.5ms at 1-Month post MRI scan visit compared to pre-MRI scan value collected at MRI scan visit~* PCTRL: the success rate in Control Group for change in RV capture threshold value @0.5ms at 1-Month post MRI scan visit compared to pre-MRI scan value collected at MRI scan visit"||2.8|-6.2|0.0012
72546998|NCT02041702|144623512|NON_INFERIORITY|The 2-sided 90% CI for difference in success rate between 2 groups was calculated by Farrington-Manning method.|Ratio Difference|-2.7||||0.0446|TWO_SIDED|90.0|-9.8|4.3|||Farrington-Manning test||The null hypothesis would be rejected if the lower bound of the two-sided 90% confidence interval was greater than -10%.|"The hypothesis was:H0: PMRI - PCTRL≤ -10% vs H1: PMRI - PCTRL \>-10%~* PMRI: the success rate in MRI Scan Group for change in RA sensing amplitude at 1-Month post MRI scan visit compared to pre-MRI scan value collected at MRI scan visit~* PCTRL: the success rate in Control Group for change in RA sensing amplitude at 1-Month post MRI scan visit compared to pre-MRI scan value collected at MRI scan visit"||4.3|-9.8|0.0446
72546999|NCT02041702|144623513|NON_INFERIORITY|The 2-sided 90% CI for difference in success rate between 2 groups was calculated by Farrington-Manning method.|Ratio Difference|2.6||||0.0002|TWO_SIDED|90.0|-3.2|8.4|||Farrington-Manning test||The null hypothesis would be rejected if the lower bound of the two-sided 90% confidence interval was greater than -10%.|"The hypothesis was: H0: PMRI - PCTRL≤ -10% vs H1: PMRI - PCTRL \>-10%~* PMRI: the success rate in the Cardiac MRI Scan Group for change in RV sensing amplitude at 1-Month post MRI scan visit compared to pre-MRI scan value collected at MRI scan visit~* PCTRL: the success rate in the Control Group for change in RV sensing amplitude at 1-Month post MRI scan visit compared to pre-MRI scan value collected at MRI scan visit"||8.4|-3.2|0.0002
72547000|NCT01379781|144623529|SUPERIORITY||Slope|-6.54||||0.01|TWO_SIDED||||||Mixed Models Analysis|||Mixed effect model was used to compare Hamilton Rating Scales of Depression (HRSD) for women who received the PREPP intervention between the pre-randomization assessment and the 6 weeks postpartum session.||||.01
72547001|NCT02708290|144623566|OTHER|Participants in the MITA group were matched to those in Control (treatment-as-usual) group using propensity score analysis based on age and all four ATEC subscales at baseline. Least squares means were calculated for all subscales at all visits.|Mean Difference (Final Values)|4.68|||<|0.0001|TWO_SIDED||||||Regression, Linear|||"The concept of a Visit was developed by dividing the three-year-long observation interval into 3-month periods. All evaluations were mapped into 3-month-long bins (Reference: Mahapatra, S. et al. Autism Dev. Disord. 2018, 1). It was then hypothesized that there was a three-way interaction between an age group, Visit, and treatment. This hypothesis was modeled by applying the Linear Model with repeated measures, where a three-way interaction term was introduced to test the hypothesis."||||<0.0001
72547002|NCT02688400|144623579|NON_INFERIORITY|"Non-inferiority of Diacerein versus Celecoxib was assessed by computing the difference in the adjusted mean change from baseline (Visit 2) in WOMAC Pain subscale score after 182 days of treatment between Diacerein and Celecoxib treatment groups from a MMRM.~Assuming that:~* Non inferiority margin of 10 points for the absolute change in WOMAC Pain Subscale Score (scale 0-100)~* SD of 26 in the two treatment groups,~* Type I error: α = 0.025 (one-sided condition) and power equal to 90%"|Mean Difference (Final Values)|0.67|||<|0.025|ONE_SIDED|95.0||3.18||MMRM. Non-inferiority claim:Diacerein to be non-inferior to Celecoxib if upper bound of the the difference in the adjusted mean change was inferior to 5 cm on the PPS.|Mixed Models Analysis|||||3.18||<0.025
72547003|NCT02688400|144623580|SUPERIORITY|||||||0.05|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||0.05
72547004|NCT02688400|144623581|SUPERIORITY|||||||0.05|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||0.05
72547005|NCT02688400|144623582|SUPERIORITY|||||||0.05|||||||Chi-squared|||||||0.05
72547006|NCT02688400|144623583|SUPERIORITY|||||||0.05|TWO_SIDED|95.0|||||Chi-squared|||||||0.05
72547007|NCT02688400|144623584|SUPERIORITY|||||||0.05|TWO_SIDED|95.0|||||Chi-squared|||||||0.05
72547008|NCT02688400|144623585|SUPERIORITY|||||||0.05|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||0.05
72547009|NCT02688400|144623586|SUPERIORITY|||||||0.05|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||0.05
72547010|NCT02688400|144623587|SUPERIORITY|||||||0.05|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||0.05
72547011|NCT02295774|144623596|SUPERIORITY_OR_OTHER||Mc Nemar's χ2 test|0.0|||||TWO_SIDED|||||||Mc Nemar's χ2 test was not applicable because there is no change between visits.|Mc Nemar's χ2 test was not applicable because there is no change between visits.|"The results of the γH2AX analysis were listed and summarised by frequency tables by visit and colonic region.~The results were compared between Visit 2 and Visit 1 for each colonic region and overall using the Mc Nemar's χ2 test.~In case of the presence of at least one positive colonic region, that visit was to be considered as 'Positive' for the overall γH2AX analysis."||||
72547012|NCT01075763|144623598|SUPERIORITY_OR_OTHER|||||||0.64|||||||t-test, 2 sided|||For baseline: the difference between the two groups was analyzed using t-test.||||0.64
72547013|NCT01075763|144623598|SUPERIORITY_OR_OTHER|||||||0.92|||||||t-test, 2 sided|||For Week 52: the difference between the two groups was analyzed using t-test.||||0.92
72547014|NCT01075763|144623599|SUPERIORITY_OR_OTHER|||||||0.63||95.0|||||t-test, 2 sided|||For Week 12: the difference between the two groups was analyzed using t-test.||||0.63
72547015|NCT01075763|144623599|SUPERIORITY_OR_OTHER|||||||0.74||95.0|||||t-test, 2 sided|||For Week 28: the difference between the two groups was analyzed using t-test.||||0.74
72547016|NCT01075763|144623600|SUPERIORITY_OR_OTHER|||||||0.45||95.0|||||t-test, 2 sided|||For baseline: the difference between the two groups was analyzed using t-test.||||0.45
72547017|NCT01075763|144623600|SUPERIORITY_OR_OTHER|||||||0.88||95.0|||||t-test, 2 sided|||For Week 12: the difference between the two groups was analyzed using t-test.||||0.88
72547018|NCT01075763|144623600|SUPERIORITY_OR_OTHER|||||||0.68||95.0|||||t-test, 2 sided|||For Week 28: the difference between the two groups was analyzed using t-test.||||0.68
72547019|NCT01075763|144623600|SUPERIORITY_OR_OTHER|||||||0.81||95.0|||||t-test, 2 sided|||For Week 52: the difference between the two groups was analyzed using t-test.||||0.81
72547020|NCT01075763|144623601|SUPERIORITY_OR_OTHER|||||||0.29||95.0|||||t-test, 2 sided|||For baseline: the difference between the two groups was analyzed using t-test.||||0.29
72547021|NCT01075763|144623601|SUPERIORITY_OR_OTHER|||||||0.36||95.0|||||t-test, 2 sided|||For Week 12: the difference between the two groups was analyzed using t-test.||||0.36
72547022|NCT01075763|144623601|SUPERIORITY_OR_OTHER|||||||0.68||95.0|||||t-test, 2 sided|||For Week 28: the difference between the two groups was analyzed using t-test.||||0.68
72547023|NCT01075763|144623601|SUPERIORITY_OR_OTHER|||||||0.41||95.0|||||t-test, 2 sided|||For Week 52: the difference between the two groups was analyzed using t-test.||||0.41
72547024|NCT01075763|144623602|SUPERIORITY_OR_OTHER|||||||0.86||95.0|||||t-test, 2 sided|||For baseline: the difference between the two groups was analyzed using t-test.||||0.86
72547025|NCT01075763|144623602|SUPERIORITY_OR_OTHER|||||||0.62||95.0|||||t-test, 2 sided|||For Week 28: the difference between the two groups was analyzed using t-test.||||0.62
72547026|NCT01075763|144623602|SUPERIORITY_OR_OTHER|||||||0.21||95.0|||||t-test, 2 sided|||For Week 52: the difference between the two groups was analyzed using t-test.||||0.21
72547027|NCT01075763|144623603|SUPERIORITY_OR_OTHER|||||||0.95||95.0|||||t-test, 2 sided|||For baseline: the difference between the two groups was analyzed using t-test.||||0.95
72580917|NCT02360215|144691454|SUPERIORITY|||||||0.0993|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A mixed effects model was run with HVLT-R Delayed Recognition Score (baseline, 2, 4, 6, and 12 months) as the outcome of interest. Age, RPA class, prior radiosurgery, prior surgical resection were the covariates considered in each model along with interaction terms treatment\*time, time\*time, time\*time\*time and remained if p\<0.05. Baseline score, treatment arm, and time were forced into the model. Treatment Arm (WBRT+Memantine vs. HA-WBRT Memantine) is reported here.||||0.0993
72580918|NCT02360215|144691454|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A mixed effects model was run with HVLT-R Delayed Recognition Score (baseline, 2, 4, 6, and 12 months) as the outcome of interest. Age, RPA class, prior radiosurgery, prior surgical resection were the covariates considered in each model along with interaction terms treatment\*time, time\*time, time\*time\*time and remained if p\<0.05. Baseline score, treatment arm, and time were forced into the model. Age (\> 61 years vs. \<= 61 years) is reported here.||||<0.0001
72580919|NCT02360215|144691454|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A mixed effects model was run with HVLT-R Delayed Recognition Score (baseline, 2, 4, 6, and 12 months) as the outcome of interest. Age, RPA class, prior radiosurgery, prior surgical resection were the covariates considered in each model along with interaction terms treatment\*time, time\*time, time\*time\*time and remained if p\<0.05. Baseline score, treatment arm, and time were forced into the model. Baseline Delayed Recognition is reported here.||||<0.0001
72580920|NCT02360215|144691455|SUPERIORITY|||||||0.5988|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A mixed effects model was run with TMT Part A (baseline, 2, 4, 6, and 12 months) as the outcome of interest. Age, RPA class, prior radiosurgery, prior surgical resection were the covariates considered in each model along with interaction terms treatment\*time, time\*time, time\*time\*time and remained if p\<0.05. Baseline score, treatment arm, and time were forced into the model. Treatment Arm (WBRT+Memantine vs. HA-WBRT Memantine) is reported here.||||0.5988
72580921|NCT02360215|144691455|SUPERIORITY|||||||0.0005|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A mixed effects model was run with TMT Part A (baseline, 2, 4, 6, and 12 months) as the outcome of interest. Age, RPA class, prior radiosurgery, prior surgical resection were the covariates considered in each model along with interaction terms treatment\*time, time\*time, time\*time\*time and remained if p\<0.05. Baseline score, treatment arm, and time were forced into the model. Age (\> 61 years vs. \<= 61 years) is reported here.||||0.0005
72580922|NCT02360215|144691455|SUPERIORITY||||||<|0.0001|||||||McNemar|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A mixed effects model was run with TMT Part A (baseline, 2, 4, 6, and 12 months) as the outcome of interest. Age, RPA class, prior radiosurgery, prior surgical resection were the covariates considered in each model along with interaction terms treatment\*time, time\*time, time\*time\*time and remained if p\<0.05. Baseline score, treatment arm, and time were forced into the model. Baseline TMT Part A is reported here.||||<0.0001
72580923|NCT02360215|144691456|SUPERIORITY|||||||0.9226|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A mixed effects model was run with TMT Part B (baseline, 2, 4, 6, and 12 months) as the outcome of interest. Age, RPA class, prior radiosurgery, prior surgical resection were the covariates considered in each model along with interaction terms treatment\*time, time\*time, time\*time\*time and remained if p\<0.05. Baseline score, treatment arm, and time were forced into the model. Treatment Arm (WBRT+Memantine vs. HA-WBRT Memantine) is reported here.||||0.9226
72580924|NCT02360215|144691456|SUPERIORITY||||||<|0.0024|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A mixed effects model was run with TMT Part B (baseline, 2, 4, 6, and 12 months) as the outcome of interest. Age, RPA class, prior radiosurgery, prior surgical resection were the covariates considered in each model along with interaction terms treatment\*time, time\*time, time\*time\*time and remained if p\<0.05. Baseline score, treatment arm, and time were forced into the model. Age (\> 61 years vs. \<= 61 years) is reported here.||||<0.0024
72580925|NCT02360215|144691456|SUPERIORITY||||||<|0.0001|||||||Regression, Cox|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A mixed effects model was run with TMT Part B (baseline, 2, 4, 6, and 12 months) as the outcome of interest. Age, RPA class, prior radiosurgery, prior surgical resection were the covariates considered in each model along with interaction terms treatment\*time, time\*time, time\*time\*time and remained if p\<0.05. Baseline score, treatment arm, and time were forced into the model. Baseline TMT Part B is reported here.||||<0.0001
72580926|NCT02360215|144691457|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A mixed effects model was run with COWA (baseline, 2, 4, 6, and 12 months) as the outcome of interest. Age, RPA class, prior radiosurgery, prior surgical resection were the covariates considered in each model along with interaction terms treatment\*time, time\*time, time\*time\*time and remained if p\<0.05. Baseline score, treatment arm, and time were forced into the model. Baseline COWA is reported here.||||<0.0001
72580927|NCT02360215|144691457|SUPERIORITY|||||||0.9749|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A mixed effects model was run with COWA (baseline, 2, 4, 6, and 12 months) as the outcome of interest. Age, RPA class, prior radiosurgery, prior surgical resection were the covariates considered in each model along with interaction terms treatment\*time, time\*time, time\*time\*time and remained if p\<0.05. Baseline score, treatment arm, and time were forced into the model. Treatment Arm (WBRT+Memantine vs. HA-WBRT Memantine) is reported here.||||0.9749
72547028|NCT01075763|144623603|SUPERIORITY_OR_OTHER|||||||0.73||95.0|||||t-test, 2 sided|||For Week 28: the difference between the two groups was analyzed using t-test.||||0.73
72547029|NCT01075763|144623603|SUPERIORITY_OR_OTHER|||||||0.3||95.0|||||t-test, 2 sided|||For Week 52: the difference between the two groups was analyzed using t-test.||||0.30
72547030|NCT01075763|144623605|SUPERIORITY_OR_OTHER|||||||0.8||95.0|||||t-test, 2 sided|||For baseline: the difference between the two groups was analyzed using t-test.||||0.80
72547031|NCT01075763|144623605|SUPERIORITY_OR_OTHER|||||||0.74||95.0|||||t-test, 2 sided|||For Week 28: the difference between the two groups was analyzed using t-test.||||0.74
72547032|NCT01075763|144623605|SUPERIORITY_OR_OTHER|||||||0.12||95.0|||||t-test, 2 sided|||For Week 52: the difference between the two groups was analyzed using t-test.||||0.12
72547033|NCT01075763|144623606|SUPERIORITY_OR_OTHER|||||||0.53||95.0|||||t-test, 2 sided|||For baseline: the difference between the two groups was analyzed using t-test.||||0.53
72547034|NCT01075763|144623606|SUPERIORITY_OR_OTHER|||||||0.85||95.0|||||t-test, 2 sided|||For Week 28: the difference between the two groups was analyzed using t-test.||||0.85
72547035|NCT01075763|144623606|SUPERIORITY_OR_OTHER|||||||0.85||95.0|||||t-test, 2 sided|||For Week 52: the difference between the two groups was analyzed using t-test.||||0.85
72547036|NCT00586521|144623607|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||The primary outcome measure was analyzed by paired t-test and Wilcoxon test (number of joint bleeds prophylaxis treatment compared to number of joint bleeds on-demand treatment) at 6 months of treatment.||||<0.001
72547037|NCT00586521|144623607|SUPERIORITY_OR_OTHER||||||<|0.001|||||||paired t-test|||The maximum individual reduction in the actual number of joint bleeds after the switch to prophylactic treatment was analyzed by a paired t-test of the individual difference between prophylaxis treatment bleed compared to on-demand treatment bleeds.||||<0.001
72547038|NCT00586521|144623608|SUPERIORITY_OR_OTHER||||||<|0.001|||||||paired t-test|||paired t-test (prophylaxis compared to on-demand) at 6 months of treatment.||||<0.001
72547039|NCT00586521|144623609|SUPERIORITY_OR_OTHER||||||<|0.001|||||||paired t-test|||The Gilbert Score was the sum of 3 scores: pain (0=no pain to 3=severe pain); bleeding score (0=none to 3=3 or more major bleeds or 7 or more minor bleeds); and physical score (based on swelling, muscle atrophy; and axial deformity (at knee or ankle), range of motion, crepitus on motion, flexion contracture, instability.||||<0.001
72547040|NCT00586521|144623610|SUPERIORITY_OR_OTHER|||||||0.314||||||The alpha level for a significant P-value was pre-defined at 5%.|paired t-test|||"The Haemo-QoL A questionnaire measures the subject's self-assessment of disease impact on physical functioning, role functioning, worry, consequences, positive affect, and treatment concern."||||0.314
72547041|NCT02261428|144623613|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.95|||<|0.05|TWO_SIDED|95.0|1.79|8.73|||Wilcoxon (Mann-Whitney)|||||8.73|1.79|<0.05
72547042|NCT01095003|144623620|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.0426|TWO_SIDED|95.0|0.71|0.99|||Log Rank|||The final analysis of progression free survival was conducted once the required number of events(615 progressions or deaths) was reached.using the IRC assessment of date of progressions following the blinded radiological and clinical review of data. Kaplan-Meier curves and life tables by treatment arm were provided.A stratified Cox proportional model was used to compare the two treatment arms||0.99|0.71|0.0426
72547043|NCT01095003|144623621|SUPERIORITY||Hazard Ratio (HR)|0.98||||0.7657|TWO_SIDED|95.0|0.83|1.15|||Log Rank|||||1.15|0.83|0.7657
72547044|NCT01095003|144623622|SUPERIORITY|||||||0.103|||||||Cochran-Mantel-Haenszel|||||||0.103
72547045|NCT01095003|144623623|SUPERIORITY|||||||0.0089|||||||Cochran-Mantel-Haenszel|||||||0.0089
72547046|NCT02006706|144623639|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.98|STANDARD_ERROR_OF_MEAN|0.606|<|0.001|TWO_SIDED|95.0|1.73|4.22|||t-test, 2 sided||The null hypothesis was that there was no difference between the DAS28 at baseline and DAS28 after 24 weeks of follow-up|||4.22|1.73|<0.001
72547047|NCT02006706|144623640|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
72547048|NCT02337933|144623667|OTHER|||||||0.003|||||||Wilcoxon (Mann-Whitney)|||||||0.003
72547049|NCT02337933|144623668|OTHER|||||||0.008|||||||Wilcoxon (Mann-Whitney)|||||||0.008
72547050|NCT02337933|144623669|OTHER|||||||0.002|||||||Wilcoxon (Mann-Whitney)|||||||0.002
72547051|NCT02337933|144623670|OTHER|||||||0.308|||||||Wilcoxon (Mann-Whitney)|||||||0.308
72547052|NCT02337933|144623671|OTHER|||||||0.575|||||||Wilcoxon (Mann-Whitney)|||||||0.575
72547053|NCT02337933|144623672|OTHER|||||||0.169|||||||Wilcoxon (Mann-Whitney)|||||||0.169
72547054|NCT02337933|144623673|OTHER|||||||0.373|||||||Wilcoxon (Mann-Whitney)|||||||0.373
72547055|NCT02337933|144623674|OTHER|||||||0.002|||||||Wilcoxon (Mann-Whitney)|||||||0.002
72547056|NCT02337933|144623675|OTHER|||||||0.049|||||||Wilcoxon (Mann-Whitney)|||||||0.049
72547057|NCT02337933|144623676|OTHER|||||||0.224|||||||Wilcoxon (Mann-Whitney)|||||||0.224
72547058|NCT02337933|144623677|OTHER|||||||0.116|||||||Wilcoxon (Mann-Whitney)|||||||0.116
72547059|NCT02337933|144623678|OTHER|||||||0.953|||||||Wilcoxon (Mann-Whitney)|||||||0.953
72412107|NCT02819726|144332229|OTHER||LS Means Difference|3.77|STANDARD_ERROR_OF_MEAN|3.268||0.2498|TWO_SIDED|95.0|-2.665|10.204|||ANCOVA|||Week 52 (EOS) Physician's Disease Activity Assessment. Least square means and confidence intervals were estimated from an ANCOVA model containing treatment group as a factor and baseline value as a covariate. Change from Study Day 1 (Baseline||10.204|-2.665|0.2498
72412108|NCT02819726|144332230|OTHER||LS Means Difference|-1.23|STANDARD_ERROR_OF_MEAN|3.592||0.7322|TWO_SIDED|95.0|-8.0302|5.841|||ANCOVA|||Week 52 (EOS) Participants Pain Assessment. Least square means and confidence intervals were estimated from an ANCOVA model containing treatment group as a factor and baseline value as a covariate. Change from Study Day 1 (Baseline).||5.841|-8.0302|0.7322
72412109|NCT02819726|144332230|OTHER||LS Means Difference|-2.21|STANDARD_ERROR_OF_MEAN|3.623||0.5418|TWO_SIDED|95.0|-9.347|4.92|||ANCOVA|||Week 52 (EOS) Participants Pain Assessment. Least square means and confidence intervals were estimated from an ANCOVA model containing treatment group as a factor and baseline value as a covariate. Change from Study Day 1 (Baseline).||4.920|-9.347|0.5418
72412110|NCT02819726|144332230|OTHER||LS Means Difference|-0.98|STANDARD_ERROR_OF_MEAN|3.633||0.7869|TWO_SIDED|95.0|-8.136|6.169|||ANCOVA|||Week 52 (EOS) Participants Pain Assessment. Least square means and confidence intervals were estimated from an ANCOVA model containing treatment group as a factor and baseline value as a covariate. Change from Study Day 1 (Baseline).||6.169|-8.136|0.7869
72412111|NCT02819726|144332231|OTHER||LS Means Difference|-1.28|STANDARD_ERROR_OF_MEAN|3.443||0.7097|TWO_SIDED|95.0|-8.062|5.496|||ANCOVA|||Week 52 (EOS) Participants Disease Activity Assessment. Least square means and confidence intervals were estimated from an ANCOVA model containing treatment group as a factor and baseline value as a covariate. Change from Study Day 1 (Baseline)||5.496|-8.062|0.7097
72412112|NCT02819726|144332231|OTHER||LS Means Difference|-1.48|STANDARD_ERROR_OF_MEAN|3.453||0.6683|TWO_SIDED|95.0|-8.28|5.317|||ANCOVA|||Week 52 (EOS) Participants Disease Activity Assessment. Least square means and confidence intervals were estimated from an ANCOVA model containing treatment group as a factor and baseline value as a covariate. Change from Study Day 1 (Baseline)||5.317|-8.280|0.6683
72412113|NCT02819726|144332231|OTHER||LS Means Difference|-0.2|STANDARD_ERROR_OF_MEAN|3.494||0.9548|TWO_SIDED|95.0|-7.078|6.682|||ANCOVA|||Week 52 (EOS) Participants Disease Activity Assessment. Least square means and confidence intervals were estimated from an ANCOVA model containing treatment group as a factor and baseline value as a covariate. Change from Study Day 1 (Baseline)||6.682|-7.078|0.9548
72547060|NCT02337933|144623679|OTHER|||||||0.999|||||||Wilcoxon (Mann-Whitney)|||||||0.999
72547061|NCT00992407|144623680|NON_INFERIORITY_OR_EQUIVALENCE|80% of power and 0.05 of significance level was used|Mean Difference (Final Values)|-0.61||||0.8595|TWO_SIDED|95.0|-7.5|6.3|||t-test, 2 sided|||Change from Baseline in Personal and Social Performance (PSP) Scale Score at Week 52||6.3|-7.5|0.8595
72547062|NCT00992407|144623681|NON_INFERIORITY_OR_EQUIVALENCE|80% of power and 0.05 of significance level was used|Mean Difference (Final Values)|1.29||||0.8118|TWO_SIDED|95.0|-9.6|12.2|||t-test, 2 sided|||Change from Baseline in Positive and Negative Syndrome Scale (PANSS) Score at Week 52||12.2|-9.6|0.8118
72547063|NCT00992407|144623690|NON_INFERIORITY_OR_EQUIVALENCE|80% of power and 0.05 of significance level was used|Mean Difference (Final Values)|10.0||||0.1768|TWO_SIDED|95.0|-4.8|24.8|||Student's t-test|||Change from Baseline in Psychosocial Well-being Index (PWI) Score at Week 52||24.8|-4.8|0.1768
72547064|NCT00992407|144623691|NON_INFERIORITY_OR_EQUIVALENCE|80% of power and 0.05 of significance level was used|Mean Difference (Final Values)|-0.33||||0.9569|TWO_SIDED|95.0|-12.8|12.2|||Student's t-test|||||12.2|-12.8|0.9569
72547065|NCT00992407|144623692|NON_INFERIORITY_OR_EQUIVALENCE|80% of power and 0.05 of significance level was used|Mean Difference (Final Values)|0.58||||0.5294|TWO_SIDED|95.0|-5.5|2.9|||t-test, 2 sided|||||2.9|-5.5|0.5294
72547066|NCT00395226|144623706|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.57||||0.284|TWO_SIDED|95.0|-0.47|1.62||The a priori significance threshold level was 0.05 (two-sided)|ANCOVA|The ANCOVA used group as a factor and baseline rosacea severity score as a covariate.|The effect of zinc sulfate treatment on rosacea severity score was estimated with baseline rosacea severity score included in the regression model|"The null hypothesis was no group differences. The alternative hypothesis was that the zinc sulfate arm is superior to placebo arm."||1.62|-0.47|0.2840
72547067|NCT02456532|144623707|OTHER|analyses of variance comparing the three treatment gropus|||||=|0.05|||||||ANOVA|||||||=0.05
72547068|NCT02456532|144623708|OTHER|ANOVA|||||=|0.643|||||||ANOVA|||||||=0.643
72547069|NCT02978326|144623727|SUPERIORITY||Least Squares (LS) Mean Difference|-4.2|STANDARD_ERROR_OF_MEAN|1.37||0.0028|TWO_SIDED|95.0|-6.9|-1.5||Mixed Model for Repeated Measures (MMRM) was used for estimation with treatment, baseline HAM-D total score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||||-1.5|-6.9|0.0028
72547070|NCT02978326|144623728|SUPERIORITY||LS Mean Difference|-2.7|STANDARD_ERROR_OF_MEAN|1.19||0.0252|TWO_SIDED|95.0|-5.1|-0.3||MMRM was used for estimation with treatment, baseline HAM-D total score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Change From Baseline in the HAM-D Total Score at Day 3||-0.3|-5.1|0.0252
72547071|NCT02978326|144623728|SUPERIORITY||LS Mean Difference|-3.4|STANDARD_ERROR_OF_MEAN|1.31||0.0106|TWO_SIDED|95.0|-6.0|-0.8||MMRM was used for estimation with treatment, baseline HAM-D total score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Change From Baseline in the HAM-D Total Score at Day 8||-0.8|-6.0|0.0106
72547072|NCT02978326|144623728|SUPERIORITY||LS Mean Difference|-3.1|STANDARD_ERROR_OF_MEAN|1.44||0.0321|TWO_SIDED|95.0|-6.0|-0.3||MMRM was used for estimation with treatment, baseline HAM-D total score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Change From Baseline in the HAM-D Total Score at Day 21||-0.3|-6.0|0.0321
72547073|NCT02978326|144623728|SUPERIORITY||LS Mean Difference|-4.1|STANDARD_ERROR_OF_MEAN|1.34||0.0027|TWO_SIDED|95.0|-6.7|-1.4||MMRM was used for estimation with treatment, baseline HAM-D total score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Change From Baseline in the HAM-D Total Score at Day 45||-1.4|-6.7|0.0027
72547074|NCT02978326|144623729|SUPERIORITY||Odds Ratio (OR)|1.79||||0.1004|TWO_SIDED|95.0|0.89|3.6||Generalized estimating equations (GEE) for binary response model was used for estimation with factors for treatment, baseline HAM-D total score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction.|GEE for binary response model|||Percentage of Participants With HAM-D Response at Day 3||3.60|0.89|0.1004
72547075|NCT02978326|144623729|SUPERIORITY||Odds Ratio (OR)|2.31||||0.0127|TWO_SIDED|95.0|1.2|4.45||Generalized estimating equations for binary response model was used for estimation with factors for treatment, baseline HAM-D total score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction.|GEE for binary response model|||Percentage of Participants With HAM-D Response at Day 8||4.45|1.20|0.0127
72547076|NCT02978326|144623729|SUPERIORITY||Odds Ratio (OR)|2.63||||0.0049|TWO_SIDED|95.0|1.34|5.16||Generalized estimating equations for binary response model was used for estimation with factors for treatment, baseline HAM-D total score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction.|GEE for binary response model|||Percentage of Participants With HAM-D Response at Day 15||5.16|1.34|0.0049
72547077|NCT02978326|144623729|SUPERIORITY||Odds Ratio (OR)|1.85||||0.0763|TWO_SIDED|95.0|0.94|3.64||Generalized estimating equations for binary response model was used for estimation with factors for treatment, baseline HAM-D total score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction.|GEE for binary response model|||Percentage of Participants With HAM-D Response at Day 21||3.64|0.94|0.0763
72547078|NCT02978326|144623729|SUPERIORITY||Odds Ratio (OR)|2.28||||0.0216|TWO_SIDED|95.0|1.13|4.6||Generalized estimating equations for binary response model was used for estimation with factors for treatment, baseline HAM-D total score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction.|GEE for binary response model|||Percentage of Participants With HAM-D Response at Day 45||4.60|1.13|0.0216
72547079|NCT02978326|144623730|SUPERIORITY||Odds Ratio (OR)|3.89||||0.02|TWO_SIDED|95.0|1.24|12.23||Generalized estimating equations for binary response model was used for estimation with factors for treatment, baseline HAM-D total score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction.|GEE for binary response model|||Percentage of Participants With HAM-D Remission at Day 3||12.23|1.24|0.0200
72547080|NCT02978326|144623730|SUPERIORITY||Odds Ratio (OR)|1.91||||0.099|TWO_SIDED|95.0|0.89|4.13||Generalized estimating equations for binary response model was used for estimation with factors for treatment, baseline HAM-D total score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction.|GEE for binary response model|||Percentage of Participants With HAM-D Remission at Day 8||4.13|0.89|0.0990
72580928|NCT02360215|144691457|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A mixed effects model was run with COWA (baseline, 2, 4, 6, and 12 months) as the outcome of interest. Age, RPA class, prior radiosurgery, prior surgical resection were the covariates considered in each model along with interaction terms treatment\*time, time\*time, time\*time\*time and remained if p\<0.05. Baseline score, treatment arm, and time were forced into the model. Age (\> 61 years vs. \<= 61 years) is reported here. is reported here.||||<0.0001
72580929|NCT02360215|144691458|SUPERIORITY|||||||0.2552|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A mixed effects model was run with the neurocognitive composite score (baseline, 2, 4, 6, and 12 months) as the outcome of interest. Age, RPA class, prior radiosurgery, prior surgical resection were the covariates considered in each model along with interaction terms treatment\*time, time\*time, time\*time\*time and remained if p\<0.05. Baseline score, treatment arm, and time were forced into the model. Treatment Arm (WBRT+Memantine vs. HA-WBRT Memantine) is reported here.||||0.2552
72547081|NCT02978326|144623730|SUPERIORITY||Odds Ratio (OR)|2.53||||0.011|TWO_SIDED|95.0|1.24|5.17||Generalized estimating equations for binary response model was used for estimation with factors for treatment, baseline HAM-D total score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction.|GEE for binary response model|||Percentage of Participants With HAM-D Remission at Day 15||5.17|1.24|0.0110
72547082|NCT02978326|144623730|SUPERIORITY||Odds Ratio (OR)|1.58||||0.1982|TWO_SIDED|95.0|0.79|3.19||Generalized estimating equations for binary response model was used for estimation with factors for treatment, baseline HAM-D total score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction.|GEE for binary response model|||Percentage of Participants With HAM-D Remission at Day 21||3.19|0.79|0.1982
72547083|NCT02978326|144623730|SUPERIORITY||Odds Ratio (OR)|2.52||||0.0091|TWO_SIDED|95.0|1.26|5.03||Generalized estimating equations for binary response model was used for estimation with factors for treatment, baseline HAM-D total score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction.|GEE for binary response model|||Percentage of Participants With HAM-D Remission at Day 45||5.03|1.26|0.0091
72547084|NCT02978326|144623731|SUPERIORITY||LS Mean Difference|-2.1|STANDARD_ERROR_OF_MEAN|2.41||0.3832|TWO_SIDED|95.0|-6.9|2.7||MMRM was used for estimation with treatment, baseline HAM-D subscale score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Core: Change from Baseline in HAM-D Subscale Score at Day 3||2.7|-6.9|0.3832
72547085|NCT02978326|144623731|SUPERIORITY||LS Mean Difference|-5.4|STANDARD_ERROR_OF_MEAN|2.6||0.0415|TWO_SIDED|95.0|-10.5|-0.2||MMRM was used for estimation with treatment, baseline HAM-D subscale score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Core: Change from Baseline in HAM-D Subscale Score at Day 8||-0.2|-10.5|0.0415
72547086|NCT02978326|144623731|SUPERIORITY||LS Mean Difference|-5.1|STANDARD_ERROR_OF_MEAN|2.71||0.0606|TWO_SIDED|95.0|-10.5|0.2||MMRM was used for estimation with treatment, baseline HAM-D subscale score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Core: Change from Baseline in HAM-D Subscale Score at Day 15||0.2|-10.5|0.0606
72412114|NCT02819726|144332232|OTHER||LS Means Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.086||0.0505|TWO_SIDED|95.0|-0.339|0.0|||ANCOVA|||Week 52 (EOS) HAQ-DI (0-3). Least square means and confidence intervals were estimated from an ANCOVA model containing treatment group as a factor and baseline value as a covariate. Change from Study Day 1 (Baseline).||0.000|-0.339|0.0505
72412115|NCT02819726|144332232|OTHER||LS Means Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.086||0.1141|TWO_SIDED|95.0|-0.307|0.033|||ANCOVA|||Week 52 (EOS) HAQ-DI (0-3). Least square means and confidence intervals were estimated from an ANCOVA model containing treatment group as a factor and baseline value as a covariate. Change from Study Day 1 (Baseline).||0.033|-0.307|0.1141
72412116|NCT02819726|144332232|OTHER||LS Means Difference|0.03|STANDARD_ERROR_OF_MEAN|0.087||0.7111|TWO_SIDED|95.0|-0.139|0.204|||ANCOVA|||Week 52 (EOS) HAQ-DI )0-3). Least square means and confidence intervals were estimated from an ANCOVA model containing treatment group as a factor and baseline value as a covariate. Change from Study Day 1 (Baseline).||0.204|-0.139|0.7111
72412117|NCT02819726|144332233|OTHER||LS Means Difference|-0.43|STANDARD_ERROR_OF_MEAN|1.871||0.8183|TWO_SIDED|95.0|-4.113|3.253|||ANCOVA|||Week 52 (EOS) CRP. Least square means and confidence intervals were estimated from an ANCOVA model containing treatment group as a factor and baseline value as a covariate. Change from Study Day 1 (Baseline).||3.253|-4.113|0.8183
72412118|NCT02819726|144332233|OTHER||LS Means Difference|1.51|STANDARD_ERROR_OF_MEAN|1.868||0.4186|TWO_SIDED|95.0|-2.164|5.191|||ANCOVA|||Week 52 (EOS) CRP. Least square means and confidence intervals were estimated from an ANCOVA model containing treatment group as a factor and baseline value as a covariate. Change from Study Day 1 (Baseline).||5.191|-2.164|0.4186
72412119|NCT02819726|144332233|OTHER||LS Means Difference|1.94|STANDARD_ERROR_OF_MEAN|1.885||0.3035|TWO_SIDED|95.0|-1.768|5.655|||ANCOVA|||Week 52 (EOS) CRP. Least square means and confidence intervals were estimated from an ANCOVA model containing treatment group as a factor and baseline value as a covariate. Change from Study Day 1 (Baseline).||5.655|-1.768|0.3035
72412120|NCT02819726|144332234|OTHER||LS Means Difference|0.02|STANDARD_ERROR_OF_MEAN|0.2||0.9249|TWO_SIDED|95.0|-0.375|0.413|||ANCOVA|||Week 52 ( EOS) Least square means and confidence intervals were estimated from an ANCOVA model containing treatment group as a factor and baseline DAS28-ESR value as a covariate. ANCOVA model contains treatment group only.||0.413|-0.375|0.9249
72547087|NCT02978326|144623731|SUPERIORITY||LS Mean Difference|-6.3|STANDARD_ERROR_OF_MEAN|2.91||0.0318|TWO_SIDED|95.0|-12.1|-0.6||MMRM was used for estimation with treatment, baseline HAM-D subscale score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Core: Change from Baseline in HAM-D Subscale Score at Day 21||-0.6|-12.1|0.0318
72412121|NCT02819726|144332234|OTHER||LS Measn Difference|0.05|STANDARD_ERROR_OF_MEAN|0.201||0.05|TWO_SIDED|95.0|-0.351|0.442|||ANCOVA|||Week 52 ( EOS) Least square means and confidence intervals were estimated from an ANCOVA model containing treatment group as a factor and baseline DAS28-ESR value as a covariate. ANCOVA model contains treatment group only.||0.442|-0.351|0.05
72547088|NCT02978326|144623731|SUPERIORITY||LS Mean Difference|-7.7|STANDARD_ERROR_OF_MEAN|2.69||0.0047|TWO_SIDED|95.0|-13.0|-2.4||MMRM was used for estimation with treatment, baseline HAM-D subscale score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Core: Change from Baseline in HAM-D Subscale Score at Day 45||-2.4|-13.0|0.0047
72580930|NCT02360215|144691458|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A mixed effects model was run with the neurocognitive composite score (baseline, 2, 4, 6, and 12 months) as the outcome of interest. Age, RPA class, prior radiosurgery, prior surgical resection were the covariates considered in each model along with interaction terms treatment\*time, time\*time, time\*time\*time and remained if p\<0.05. Baseline score, treatment arm, and time were forced into the model. Age (\> 61 years vs. \<= 61 years) is reported here.||||<0.0001
72412122|NCT02819726|144332234|OTHER||LS Means Diference|0.03|STANDARD_ERROR_OF_MEAN|0.205||0.8962|TWO_SIDED|95.0|-0.376|0.43|||ANCOVA|||Week 52 ( EOS) Least square means and confidence intervals were estimated from an ANCOVA model containing treatment group as a factor and baseline DAS28-ESR value as a covariate. ANCOVA model contains treatment group only.||0.430|-0.376|0.8962
72412123|NCT02819726|144332235|OTHER||Difference (%)|2.2|STANDARD_ERROR_OF_MEAN|1.57|||TWO_SIDED|95.0|-2.56|7.83||||||Week 52 (EOS) Major Clinical Response. The 95% CIs for major clinical response rate and treatment difference were derived using the Wilson Score method. The adjusted difference and its 95% CI are from a logistic regression model containing treatment group as a factor and baseline DAS28-CRP as a covariate.||7.83|-2.56|
72412124|NCT02819726|144332235|OTHER||Difference (%)|1.0|STANDARD_ERROR_OF_MEAN|2.0|||TWO_SIDED|95.0|-4.74|6.67||||||Week 52 (EOS) Major Clinical Response. The 95% CIs for major clinical response rate and treatment difference were derived using the Wilson Score method. The adjusted difference and its 95% CI are from a logistic regression model containing treatment group as a factor and baseline DAS28-CRP as a covariate.||6.67|-4.74|
72412125|NCT02819726|144332235|OTHER||Difference (%)|-1.3|STANDARD_ERROR_OF_MEAN|1.24|||TWO_SIDED|95.0|-6.75|3.39||||||Week 52 (EOS) Major Clinical Response. The 95% CIs for major clinical response rate and treatment difference were derived using the Wilson Score method. The adjusted difference and its 95% CI are from a logistic regression model containing treatment group as a factor and baseline DAS28-CRP as a covariate.||3.39|-6.75|
72412126|NCT02819726|144332236|OTHER||Difference (%)|-1.2|STANDARD_ERROR_OF_MEAN|1.92|||TWO_SIDED|95.0|-6.9|3.9||||||Week 52 (EOS). Clinical remission is defined as score of Simplified Disease Activity Index (SDAI) smaller than 3.3. The 95% CIs for clinical remission rate and treatment difference were derived using the Wilson Score method. The adjusted difference and its 95% CI are from a logistic regression model containing treatment group as a factor and baseline DAS28-CRP as a covariate.||3.90|-6.9|
72547089|NCT02978326|144623731|SUPERIORITY||LS Mean Difference|-7.1|STANDARD_ERROR_OF_MEAN|2.5||0.0053|TWO_SIDED|95.0|-12.0|-2.1||MMRM was used for estimation with treatment, baseline HAM-D subscale score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Anxiety: Change from Baseline in HAM-D Subscale Score at Day 3||-2.1|-12.0|0.0053
72547090|NCT02978326|144623731|SUPERIORITY||LS Mean Difference|-6.6|STANDARD_ERROR_OF_MEAN|2.76||0.0181|TWO_SIDED|95.0|-12.1|-1.1||MMRM was used for estimation with treatment, baseline HAM-D subscale score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Anxiety: Change from Baseline in HAM-D Subscale Score at Day 8||-1.1|-12.1|0.0181
72547091|NCT02978326|144623731|SUPERIORITY||LS Mean Difference|-9.8|STANDARD_ERROR_OF_MEAN|2.82||0.0007|TWO_SIDED|95.0|-15.3|-4.2|||Mixed Model for Repeated Measures|||Anxiety: Change from Baseline in HAM-D Subscale Score at Day 15||-4.2|-15.3|0.0007
72547092|NCT02978326|144623731|OTHER||LS Mean Difference|-6.0|STANDARD_ERROR_OF_MEAN|2.79||0.0332|TWO_SIDED|95.0|-11.5|-0.5|||Mixed Model for Repeated Measures|||Anxiety: Change from Baseline in HAM-D Subscale Score at Day 21||-0.5|-11.5|0.0332
72547093|NCT02978326|144623731|OTHER||LS Mean Difference|-8.0|STANDARD_ERROR_OF_MEAN|2.8||0.0048|TWO_SIDED|95.0|-13.5|-2.5||MMRM was used for estimation with treatment, baseline HAM-D subscale score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Anxiety: Change from Baseline in HAM-D Subscale Score at Day 45||-2.5|-13.5|0.0048
72547094|NCT02978326|144623731|SUPERIORITY||LS Mean Difference|-4.2|STANDARD_ERROR_OF_MEAN|3.12||0.184|TWO_SIDED|95.0|-10.3|2.0||MMRM was used for estimation with treatment, baseline HAM-D subscale score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Bech-6: Change from Baseline in HAM-D Subscale Score at Day 3||2.0|-10.3|0.1840
72547095|NCT02978326|144623731|SUPERIORITY||LS Mean Difference|-6.7|STANDARD_ERROR_OF_MEAN|3.31||0.0462|TWO_SIDED|95.0|-13.2|-0.1||MMRM was used for estimation with treatment, baseline HAM-D subscale score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Bech-6: Change from Baseline in HAM-D Subscale Score at Day 8||-0.1|-13.2|0.0462
72547096|NCT02978326|144623731|SUPERIORITY||LS Mean Difference|-8.3|STANDARD_ERROR_OF_MEAN|3.36||0.015|TWO_SIDED|95.0|-14.9|-1.6||MMRM was used for estimation with treatment, baseline HAM-D subscale score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Bech-6: Change from Baseline in HAM-D Subscale Score at Day 15||-1.6|-14.9|0.0150
72547097|NCT02978326|144623731|SUPERIORITY||LS Mean Difference|-8.0|STANDARD_ERROR_OF_MEAN|3.53||0.0245|TWO_SIDED|95.0|-15.0|-1.0||MMRM was used for estimation with treatment, baseline HAM-D subscale score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Bech-6: Change from Baseline in HAM-D Subscale Score at Day 21||-1.0|-15.0|0.0245
72547098|NCT02978326|144623731|SUPERIORITY||LS Mean Difference|-9.4|STANDARD_ERROR_OF_MEAN|3.34||0.0054|TWO_SIDED|95.0|-16.0|-2.8||MMRM was used for estimation with treatment, baseline HAM-D subscale score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Bech-6: Change from Baseline in HAM-D Subscale Score at Day 45||-2.8|-16.0|0.0054
72547099|NCT02978326|144623731|SUPERIORITY||LS Mean Difference|-4.6|STANDARD_ERROR_OF_MEAN|2.77||0.0972|TWO_SIDED|95.0|-10.1|0.9||MMRM was used for estimation with treatment, baseline HAM-D subscale score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Meier: Change from Baseline in HAM-D Subscale Score at Day 3||0.9|-10.1|0.0972
72547100|NCT02978326|144623731|SUPERIORITY||LS Mean Difference|-7.2|STANDARD_ERROR_OF_MEAN|2.95||0.0155|TWO_SIDED|95.0|-13.1|-1.4||MMRM was used for estimation with treatment, baseline HAM-D subscale score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Meier: Change from Baseline in HAM-D Subscale Score at Day 8||-1.4|-13.1|0.0155
72547101|NCT02978326|144623731|SUPERIORITY||LS Mean Difference|-7.5|STANDARD_ERROR_OF_MEAN|3.03||0.0149|TWO_SIDED|95.0|-13.4|-1.5||MMRM was used for estimation with treatment, baseline HAM-D subscale score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Meier: Change from Baseline in HAM-D Subscale Score at Day 15||-1.5|-13.4|0.0149
72547102|NCT02978326|144623731|SUPERIORITY||LS Mean Difference|-7.1|STANDARD_ERROR_OF_MEAN|3.14||0.025|TWO_SIDED|95.0|-13.3|-0.9||MMRM was used for estimation with treatment, baseline HAM-D subscale score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Meier: Change from Baseline in HAM-D Subscale Score at Day 21||-0.9|-13.3|0.0250
72547103|NCT02978326|144623731|SUPERIORITY||LS Mean Difference|-9.5|STANDARD_ERROR_OF_MEAN|2.96||0.0017|TWO_SIDED|95.0|-15.3|-3.6||MMRM was used for estimation with treatment, baseline HAM-D subscale score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Meier: Change from Baseline in HAM-D Subscale Score at Day 45||-3.6|-15.3|0.0017
72580931|NCT02360215|144691458|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A mixed effects model was run with the neurocognitive composite score (baseline, 2, 4, 6, and 12 months) as the outcome of interest. Age, RPA class, prior radiosurgery, prior surgical resection were the covariates considered in each model along with interaction terms treatment\*time, time\*time, time\*time\*time and remained if p\<0.05. Baseline score, treatment arm, and time were forced into the model. Baseline composite score is reported here.||||<0.0001
72580932|NCT02360215|144691459|SUPERIORITY|||||||0.57|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A mixed effects model was run with MDASI-BT Symptom Score (baseline, 2, 4, 6, and 12 months) as the outcome of interest. Age, RPA class, prior radiosurgery, prior surgical resection were the covariates considered in each model along with interaction terms treatment\*time, time\*time, time\*time\*time and remained if p\<0.05. Baseline score, treatment arm, and time were forced into the model. Treatment Arm (WBRT+Memantine vs. HA-WBRT Memantine) is reported here.||||0.57
72580933|NCT02360215|144691459|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A mixed effects model was run with MDASI-BT Symptom Severity score (baseline, 2, 4, 6, and 12 months) as the outcome of interest. Age, RPA class, prior radiosurgery, prior surgical resection were the covariates considered in each model along with interaction terms treatment\*time, time\*time, time\*time\*time and remained if p\<0.05. Baseline score, treatment arm, and time were forced into the model. Baseline symptom severity is reported here.||||<0.0001
72580934|NCT02360215|144691459|SUPERIORITY|||||||0.083|||||||Mixed Models Analysis|||A two-sample t-test with a 2-sided type I error of 0.05 provides \>90% statistical power to detect a medium effect size of 0.5 for a comparison of the change from baseline to 6 months from the start of treatment. The comparison at six months was tested within a mixed effects model with covariates age, RPA class, prior radiosurgery, prior surgical resection, baseline score, treatment arm, and time was used.||||0.083
72580935|NCT02360215|144691460|SUPERIORITY|||||||0.9118|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A mixed effects model was run with MDASI-BT Interference Score (baseline, 2, 4, 6, and 12 months) as the outcome of interest. Age, RPA class, prior radiosurgery, prior surgical resection were the covariates considered in each model along with interaction terms treatment\*time, time\*time, time\*time\*time and remained if p\<0.05. Baseline score, treatment arm, and time were forced into the model. Treatment Arm (WBRT+Memantine vs. HA-WBRT Memantine) is reported here.||||0.9118
72580936|NCT02360215|144691460|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A mixed effects model was run with MDASI-BT Interference Score (baseline, 2, 4, 6, and 12 months) as the outcome of interest. Age, RPA class, prior radiosurgery, prior surgical resection were the covariates considered in each model along with interaction terms treatment\*time, time\*time, time\*time\*time and remained if p\<0.05. Baseline score, treatment arm, and time were forced into the model. Baseline interference score is reported here.||||<0.0001
72580937|NCT02360215|144691461|SUPERIORITY|||||||0.1964|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A mixed effects model was run with MDASI-BT Cognitive Factor Score (baseline, 2, 4, 6, and 12 months) as the outcome of interest. Age, RPA class, prior radiosurgery, prior surgical resection were the covariates considered in each model along with interaction terms treatment\*time, time\*time, time\*time\*time and remained if p\<0.05. Baseline score, treatment arm, and time were forced into the model. Treatment Arm (WBRT+Memantine vs. HA-WBRT Memantine) is reported here.||||0.1964
72580938|NCT02360215|144691461|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A mixed effects model was run with MDASI-BT Cognitive Factor Score (baseline, 2, 4, 6, and 12 months) as the outcome of interest. Age, RPA class, prior radiosurgery, prior surgical resection were the covariates considered in each model along with interaction terms treatment\*time, time\*time, time\*time\*time and remained if p\<0.05. Baseline score, treatment arm, and time were forced into the model. Baseline cognitive factor score is reported here.||||<0.0001
72580939|NCT02360215|144691461|SUPERIORITY|||||||0.0032|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A mixed effects model was run with MDASI-BT Cognitive Factor Score (baseline, 2, 4, 6, and 12 months) as the outcome of interest. Age, RPA class, prior radiosurgery, prior surgical resection were the covariates considered in each model along with interaction terms treatment\*time, time\*time, time\*time\*time and remained if p\<0.05. Baseline score, treatment arm, and time were forced into the model. Prior radiotherapy (yes vs. no) is reported here.||||0.0032
72580940|NCT02360215|144691462|SUPERIORITY|||||||0.8877|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A mixed effects model was run with MDASI-BT Neurologic Factor Score (baseline, 2, 4, 6, and 12 months) as the outcome of interest. Age, RPA class, prior radiosurgery, prior surgical resection were the covariates considered in each model along with interaction terms treatment\*time, time\*time, time\*time\*time and remained if p\<0.05. Baseline score, treatment arm, and time were forced into the model. Treatment Arm (WBRT+Memantine vs. HA-WBRT Memantine) is reported here.||||0.8877
72547104|NCT02978326|144623732|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.16||0.1569|TWO_SIDED|95.0|-0.5|0.1||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Depressed Mood: Change From Baseline in HAM-D Individual Item Score at Day 3||0.1|-0.5|0.1569
72547105|NCT02978326|144623732|SUPERIORITY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.18||0.0376|TWO_SIDED|95.0|-0.7|0.0||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Depressed Mood: Change From Baseline in HAM-D Individual Item Score at Day 8||0.0|-0.7|0.0376
72547106|NCT02978326|144623732|SUPERIORITY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.18||0.1035|TWO_SIDED|95.0|-0.6|0.1||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Depressed Mood: Change From Baseline in HAM-D Individual Item Score at Day 15||0.1|-0.6|0.1035
72580941|NCT02360215|144691462|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A mixed effects model was run with MDASI-BT Neurologic Factor Score (baseline, 2, 4, 6, and 12 months) as the outcome of interest. Age, RPA class, prior radiosurgery, prior surgical resection were the covariates considered in each model along with interaction terms treatment\*time, time\*time, time\*time\*time and remained if p\<0.05. Baseline score, treatment arm, and time were forced into the model. Baseline neurologic factor is reported here.||||<0.0001
72580942|NCT02360215|144691462|SUPERIORITY|||||||0.0078|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A mixed effects model was run with MDASI-BT Neurologic Factor Score (baseline, 2, 4, 6, and 12 months) as the outcome of interest. Age, RPA class, prior radiosurgery, prior surgical resection were the covariates considered in each model along with interaction terms treatment\*time, time\*time, time\*time\*time and remained if p\<0.05. Baseline score, treatment arm, and time were forced into the model. Age (\> 61 years vs. \<= 61 years) is reported here.||||0.0078
72580943|NCT02360215|144691463|SUPERIORITY|||||||0.86||||||Significance level = 0.05|t-test, 2 sided|||||||0.86
72580944|NCT02360215|144691465|SUPERIORITY|||||||0.95||||||Significance level = 0.05|t-test, 2 sided|||||||0.95
72580945|NCT02360215|144691466|SUPERIORITY|||||||0.66||||||Significance level = 0.05|t-test, 2 sided|||||||0.66
72580946|NCT02360215|144691467|SUPERIORITY|||||||0.18||||||Significance level = 0.05|t-test, 2 sided|||||||0.18
72580947|NCT02360215|144691468|SUPERIORITY|||||||0.64||||||Significance level = 0.05|t-test, 2 sided|||||||0.64
72580948|NCT02360215|144691469|SUPERIORITY|||||||0.91||||||Significance level = 0.05|t-test, 2 sided|||||||0.91
72580949|NCT02360215|144691470|OTHER|||||||0.92||||||Significance level = 0.05|t-test, 2 sided|||||||0.92
72580950|NCT02360215|144691471|SUPERIORITY||Hazard Ratio (HR)|1.2||||0.076|TWO_SIDED|95.0|0.98|1.47||Two-sided significance level = 0.05|Log Rank||Reference level = WBRT + Memantine|||1.47|0.98|0.076
72412127|NCT02819726|144332236|OTHER||Difference (%)|-1.2|STANDARD_ERROR_OF_MEAN|1.95|||TWO_SIDED|95.0|-7.07|3.86||||||Week 52 (EOS). Clinical remission is defined as score of Simplified Disease Activity Index (SDAI) smaller than 3.3. The 95% CIs for clinical remission rate and treatment difference were derived using the Wilson Score method. The adjusted difference and its 95% CI are from a logistic regression model containing treatment group as a factor and baseline DAS28-CRP as a covariate.||3.86|-7.07|
72580951|NCT02360215|144691472|SUPERIORITY||Hazard Ratio (HR)|1.14||||0.242|TWO_SIDED|95.0|0.91|1.43||Two-sided significance level = 0.05|Log Rank||Reference level = WBRT + Memantin|||1.43|0.91|0.242
72580952|NCT02360215|144691473|SUPERIORITY|||||||0.47||||||Two-sided p-value = 0.05|Chi-squared|||||||0.47
72580953|NCT02603146|144691478|OTHER||Cumulative Probability|0.336|||||TWO_SIDED|95.0|0.213|0.459|||||Using Kaplan-Meier product-limit method (and Greenwood's formula for confidence interval), estimated the cumulative probability of development of CL-RA by Month 36 for HCQ.|||0.459|0.213|
72580954|NCT02603146|144691478|OTHER||Cumulative Probability|0.394|||||TWO_SIDED|95.0|0.268|0.519|||||Using Kaplan-Meier product-limit method (and Greenwood's formula for confidence interval), estimated the cumulative probability of development of CL-RA by Month 36 for Placebo.|||0.519|0.268|
72580955|NCT02603146|144691478|SUPERIORITY|"The analysis is based on the KM estimated risk of CL- RA at 36 months, where risk = (1-KM estimated probability of survival). Survival for this analysis is defined as absence of CL-RA. Estimated risks were derived from a Kaplan-Meier curve using censored time-to-event data to account for attrition under the assumption of non-informative censoring."|Risk Difference (RD)|-0.058||||0.522|TWO_SIDED|95.0|-0.336|0.22||The test statistic is a Wald-type chi-square statistic derived by dividing the difference of the logit-transformed KM survival estimates for each arm by the associated variance derived using the delta-method \[Klein, et. al. 2007\].|Chi-squared||Risk difference for HCQ - Placebo|||0.220|-0.336|0.522
72580956|NCT02603146|144691479|OTHER||Cumulative Probability|0.165|||||TWO_SIDED|95.0|0.076|0.225|||||Using Kaplan-Meier product-limit method (and Greenwood's formula for confidence interval), estimated the cumulative probability of development of CL-RA by Month 12 for HCQ.|||0.225|0.076|
72580957|NCT02603146|144691479|OTHER||Cumulative Probability|0.194|||||TWO_SIDED|95.0|0.099|0.289|||||Using Kaplan-Meier product-limit method (and Greenwood's formula for confidence interval), estimated the cumulative probability of development of CL-RA by Month 12 for Placebo.|||0.289|0.099|
72580958|NCT02603146|144691479|SUPERIORITY|"The analysis is based on the KM estimated risk of CL- RA at 12 months, where risk = (1-KM estimated probability of survival). Survival for this analysis is defined as absence of CL-RA. Estimated risks were derived from a Kaplan-Meier curve using censored time-to-event data to account for attrition under the assumption of non-informative censoring."|Risk Difference (RD)|-0.029||||0.668|TWO_SIDED|95.0|-0.188|0.131||The test statistic is a Wald-type chi-square statistic derived by dividing the difference of the logit-transformed KM survival estimates for each arm by the associated variance derived using the delta-method \[Klein, et. al. 2007\].|Chi-squared||Risk difference for HCQ - Placebo|||0.131|-0.188|0.668
72412128|NCT02819726|144332236|OTHER||Differnce (%)|-0.1|STANDARD_ERROR_OF_MEAN|2.27|||TWO_SIDED|95.0|-6.05|5.83||||||Week 52 (EOS). Clinical remission is defined as score of Simplified Disease Activity Index (SDAI) smaller than 3.3. The 95% CIs for clinical remission rate and treatment difference were derived using the Wilson Score method. The adjusted difference and its 95% CI are from a logistic regression model containing treatment group as a factor and baseline DAS28-CRP as a covariate.||5.83|-6.05|
72580959|NCT02603146|144691480|OTHER||Cumulative Probability|0.18|||||TWO_SIDED|95.0|0.088|0.273|||||Using Kaplan-Meier product-limit method (and Greenwood's formula for confidence interval), estimated the cumulative probability of development of IA by Month 12 for HCQ.|||0.273|0.088|
72580960|NCT02603146|144691480|OTHER||Cumulative Probability|0.194|||||TWO_SIDED|95.0|0.099|0.289|||||Using Kaplan-Meier product-limit method (and Greenwood's formula for confidence interval), estimated the cumulative probability of development of IA by Month 12 for Placebo.|||0.289|0.099|
72580961|NCT02603146|144691480|SUPERIORITY|"The analysis is based on the KM estimated risk of IA at 12 months, where risk = (1-KM estimated probability of survival). Survival for this analysis is defined as absence of IA. Estimated risks were derived from a Kaplan-Meier curve using censored time-to-event data to account for attrition under the assumption of non-informative censoring."|Risk Difference (RD)|-0.014||||0.84|TWO_SIDED|95.0|-0.177|0.15||The test statistic is a Wald-type chi-square statistic derived by dividing the difference of the logit-transformed KM survival estimates for each arm by the associated variance derived using the delta-method \[Klein, et. al. 2007\].|Chi-squared||Risk difference for HCQ - Placebo|||0.150|-0.177|0.840
72580962|NCT02603146|144691481|SUPERIORITY|||||||0.652|||||||Log Rank|||||||0.652
72580963|NCT02603146|144691482|OTHER||Cumulative Probability|0.356|||||TWO_SIDED|95.0|0.23|0.482|||||Using Kaplan-Meier product-limit method (and Greenwood's formula for confidence interval), estimated the cumulative probability of development of IA by Month 36 for HCQ.|||0.482|0.230|
72580964|NCT02603146|144691482|OTHER||Cumulative Probability|0.425|||||TWO_SIDED|95.0|0.298|0.551|||||Using Kaplan-Meier product-limit method (and Greenwood's formula for confidence interval), estimated the cumulative probability of development of IA by Month 36 for Placebo.|||0.551|0.298|
72580965|NCT02603146|144691482|SUPERIORITY|"The analysis is based on the KM estimated risk of IA at 36 months, where risk = (1-KM estimated probability of survival). Survival for this analysis is defined as absence of IA. Estimated risks were derived from a Kaplan-Meier curve using censored time-to-event data to account for attrition under the assumption of non-informative censoring."|Risk Difference (RD)|-0.069||||0.452|TWO_SIDED|95.0|-0.363|0.226||The test statistic is a Wald-type chi-square statistic derived by dividing the difference of the logit-transformed KM survival estimates for each arm by the associated variance derived using the delta-method \[Klein, et. al. 2007\].|Chi-squared||Risk difference for HCQ - Placebo|||0.226|-0.363|0.452
72580966|NCT02603146|144691483|SUPERIORITY|||||||0.928||||||Week 52 results|Wilcoxon (Mann-Whitney)|||||||0.928
72580967|NCT02603146|144691483|SUPERIORITY|||||||0.076||||||Month 36 results|Wilcoxon (Mann-Whitney)|||||||0.076
72580968|NCT02603146|144691484|SUPERIORITY|||||||0.781||||||Week 52 results|Wilcoxon (Mann-Whitney)|||||||0.781
72580969|NCT02603146|144691484|SUPERIORITY|||||||0.457||||||Month 36 results|Wilcoxon (Mann-Whitney)|||||||0.457
72580970|NCT02603146|144691485|SUPERIORITY|||||||0.576||||||Week 52 results|Wilcoxon (Mann-Whitney)|||||||0.576
72580971|NCT02603146|144691485|SUPERIORITY|||||||0.323||||||Month 36 results|Wilcoxon (Mann-Whitney)|||||||0.323
72580972|NCT02603146|144691486|SUPERIORITY|||||||0.865||||||Week 52 results|Wilcoxon (Mann-Whitney)|||||||0.865
72580973|NCT02603146|144691486|SUPERIORITY|||||||0.179||||||Month 36 results|Wilcoxon (Mann-Whitney)|||||||0.179
72580974|NCT02603146|144691487|SUPERIORITY|||||||0.634||||||Week 52 results|Wilcoxon (Mann-Whitney)|||||||0.634
72580975|NCT02603146|144691487|SUPERIORITY|||||||0.574||||||Month 36 results|Wilcoxon (Mann-Whitney)|||||||0.574
72580976|NCT02603146|144691488|SUPERIORITY|||||||0.724||||||Week 52 results|Wilcoxon (Mann-Whitney)|||||||0.724
72580977|NCT02603146|144691488|SUPERIORITY|||||||0.149||||||Month 36 results|Wilcoxon (Mann-Whitney)|||||||0.149
72580978|NCT02603146|144691492|SUPERIORITY|||||||0.809|||||||Fisher Exact|||||||0.809
72580979|NCT01783990|144691515|SUPERIORITY|||||||0.33|||||||Fisher Exact|||The primary analysis compared the frequency of worsening spleen function (from normal to decreased or absent, or from decreased to absent).||||0.33
72580980|NCT01783990|144691516|SUPERIORITY|||||||0.8|||||||Fisher Exact|||The primary analysis compared the frequency of worsening spleen function (from normal to decreased or absent, or from decreased to absent).||||0.80
72580981|NCT01783990|144691517|SUPERIORITY|||||||0.87|||||||Kruskal-Wallis|||Kruskal-Wallis test was used to test if there were a statistically significant difference between the two treatment groups.||||0.87
72580982|NCT01783990|144691518|SUPERIORITY|||||||0.28|||||||Kruskal-Wallis|||Kruskal-Wallis test was used to test if there were a statistically significant difference between the two treatment groups.||||0.28
72580983|NCT01783990|144691519|SUPERIORITY|||||||0.31|||||||Kruskal-Wallis|||Kruskal-Wallis test was used to test if there were a statistically significant difference between the two treatment groups.||||0.31
72580984|NCT01783990|144691520|SUPERIORITY|||||||0.04|||||||Kruskal-Wallis|||Kruskal-Wallis test was used to test if there were a statistically significant difference between the two treatment groups.||||0.04
72580985|NCT02203357|144691521|SUPERIORITY||||||<|0.05|TWO_SIDED|95.0||||The p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance.|ANOVA|||||||<0.05
72580986|NCT01050530|144691525|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.51|||<|0.0001|TWO_SIDED|95.0|-2.08|-0.93|||t-test, 2 sided|||||-0.93|-2.08|<0.0001
72580987|NCT01050530|144691526|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-300.7||||0.0093|TWO_SIDED|95.0|-526.2|-75.1|||t-test, 2 sided|||||-75.1|-526.2|0.0093
72580988|NCT01332487|144691535|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||Acute Urinary Retention|Chi-squared|||||||0.002
72580989|NCT01332487|144691535|SUPERIORITY_OR_OTHER|||||||0||95.0||||Surgery|Chi-squared|||||||0.000
72580990|NCT01332487|144691535|SUPERIORITY_OR_OTHER|||||||0.597||95.0||||Emergency Surgery|Chi-squared|||||||0.597
72580991|NCT02440464|144691557|SUPERIORITY|||||||1||||||Statistical significance was determined using a pre-specified one-sided threshold of 0.10.|Log Rank|||The null hypothesis is that there is no difference in progression-free survival time post-randomization among randomized subjects receiving Ixazomib vs Placebo maintenance therapy during the 21 month period post-randomization. This was compared between treatment arms using a log rank test.||||1.0
72580992|NCT02440464|144691558|SUPERIORITY|||||||1||||||Statistical significance was determined using a pre-specified one-sided threshold of 0.05.|Gray's Test|||The null hypothesis is that there is no difference in the proportions of participants with acute grade III-IV GVHD between the Ixazomib and Placebo arms during 100 days post-randomization, with death prior to acute GVHD treated as a competing risk. Cumulative incidences are compared between treatment arms using Gray's test.||||1.0
72580993|NCT02440464|144691559|SUPERIORITY|||||||1||||||Statistical significance was determined using a pre-specified one-sided threshold of 0.05.|Gray's Test|||The null hypothesis is that there is no difference in the proportions of participants with chronic GVHD between the Ixazomib and Placebo arms during 21 months post-randomization, with death prior to chronic GVHD treated as a competing risk. Cumulative incidences are compared between treatment arms using Gray's test.||||1.0
72580994|NCT02440464|144691560|SUPERIORITY|The null hypothesis is that there is no difference in the proportions of participants in the best response to treatment categories between the Ixazomib and Placebo arms during 2 years post-transplant among participants in sCR/CR at randomization. These proportions were compared using Fisher's Exact test.||||||0.89|||||||Fisher Exact|Statistical significance was determined using a pre-specified one-sided threshold of 0.05.||Participants in sCR/CR at Randomization||||0.890
72580995|NCT02440464|144691560|SUPERIORITY|||||||0.754||||||Statistical significance was determined using a pre-specified one-sided threshold of 0.05.|Fisher Exact|||The null hypothesis is that there is no difference in the proportions of participants in the best response to treatment categories between the Ixazomib and Placebo arms during 2 years post-transplant among participants not in sCR/CR at randomization. These proportions were compared using Fisher's Exact test.||||0.754
72580996|NCT02440464|144691562|SUPERIORITY|||||||1||||||Statistical significance was determined using a pre-specified one-sided threshold of 0.05.|Gray's Test|||The null hypothesis is that there is no difference in the proportions of participants with progression between the Ixazomib and Placebo arms during 21 months post-randomization, with death prior to progression treated as a competing risk. Cumulative incidences are compared between treatment arms using Gray's test.||||1.0
72580997|NCT02440464|144691563|SUPERIORITY|||||||0.174||||||Statistical significance was determined using a pre-specified one-sided threshold of 0.05.|Log Rank|||The null hypothesis is that there is no difference in overall survival time post-randomization among randomized subjects receiving Ixazomib vs Placebo maintenance therapy during the 21 month period post-randomization. This was compared between treatment arms using a log rank test.||||0.174
72580998|NCT02440464|144691564|SUPERIORITY|||||||0.173||||||Statistical significance was determined using a pre-specified one-sided threshold of 0.05.|Gray's Test|||The null hypothesis is that there is no difference in the proportions of participants with treatment-related mortality between the Ixazomib and Placebo arms during 21 months post-randomization, with progression treated as a competing risk. Cumulative incidences are compared between treatment arms using Gray's test.||||0.173
72580999|NCT02440464|144691566|SUPERIORITY|||||||0.258||||||Statistical significance was determined using a pre-specified one-sided threshold of 0.05.|Z test|||The null hypothesis is that there is no difference in the proportions of participants with Grade 3-5 toxicities between the Ixazomib and Placebo arms during 6 months post-randomization, with death from a cause other than toxicity treated as a competing risk. Cumulative incidences are estimated at 6, 12 and 18 months post randomization using Aalen-Johansen estimators for each treatment group. Comparison of cumulative incidence between treatment arms was done using a Z test at fixed time points.||||0.258
72581000|NCT02440464|144691566|SUPERIORITY|||||||0.252||||||Statistical significance was determined using a pre-specified one-sided threshold of 0.05.|Z test|||The null hypothesis is that there is no difference in the proportions of participants with Grade 3-5 toxicities between the Ixazomib and Placebo arms during 12 months post-randomization, with death from a cause other than toxicity treated as a competing risk. Cumulative incidences are estimated at 6, 12 and 18 months post randomization using Aalen-Johansen estimators for each treatment group. Comparison of cumulative incidence between treatment arms was done using a Z test at fixed time points.||||0.252
72581001|NCT02440464|144691566|SUPERIORITY|||||||0.258||||||Statistical significance was determined using a pre-specified one-sided threshold of 0.05.|Z test|||The null hypothesis is that there is no difference in the proportions of participants with Grade 3-5 toxicities between the Ixazomib and Placebo arms during 18 months post-randomization, with death from a cause other than toxicity treated as a competing risk. Cumulative incidences are estimated at 6, 12 and 18 months post randomization using Aalen-Johansen estimators for each treatment group. Comparison of cumulative incidence between treatment arms was done using a Z test at fixed time points.||||0.258
72581002|NCT02440464|144691568|SUPERIORITY|||||||1||||||Statistical significance was determined using a pre-specified one-sided threshold of 0.05.|Z test|||The null hypothesis is that there is no difference in the proportions of participants with Grade 3 infections between the Ixazomib and Placebo arms during 6 months post-randomization, with death from a cause other than infection treated as a competing risk. Cumulative incidences are estimated at 6, 12 and 18 months post randomization using Aalen-Johansen estimators for each treatment group. Comparison of cumulative incidence between treatment arms was done using a Z test at fixed time points.||||1.0
72581003|NCT02440464|144691568|SUPERIORITY|||||||1||||||Statistical significance was determined using a pre-specified one-sided threshold of 0.05.|Z test|||The null hypothesis is that there is no difference in the proportions of participants with Grade 3 infections between the Ixazomib and Placebo arms during 12 months post-randomization, with death from a cause other than infection treated as a competing risk. Cumulative incidences are estimated at 6, 12 and 18 months post randomization using Aalen-Johansen estimators for each treatment group. Comparison of cumulative incidence between treatment arms was done using a Z test at fixed time points.||||1.0
72581004|NCT02440464|144691568|SUPERIORITY|||||||1||||||Statistical significance was determined using a pre-specified one-sided threshold of 0.05.|Z test|||The null hypothesis is that there is no difference in the proportions of participants with Grade 3 infections between the Ixazomib and Placebo arms during 18 months post-randomization, with death from a cause other than infection treated as a competing risk. Cumulative incidences are estimated at 6, 12 and 18 months post randomization using Aalen-Johansen estimators for each treatment group. Comparison of cumulative incidence between treatment arms was done using a Z test at fixed time points.||||1.0
72581005|NCT01958437|144691590|SUPERIORITY|||||||0.048|||||||ANCOVA|||RM ANCOVA (covarying order) for cognitively intact groups||||.048
72581006|NCT01958437|144691590|SUPERIORITY|||||||0.063|||||||ANCOVA|||RM ANCOVA (covarying order) for MCI group||||.063
72581007|NCT01958437|144691591|SUPERIORITY|||||||0.27|||||||ANCOVA|Main effect of stimulation covarying session order||Change between active and sham tDCS sessions for allocentric blocks||||.27
72581008|NCT01958437|144691591|SUPERIORITY||||||<|0.001|||||||ANCOVA|||||||<.001
72581009|NCT01958437|144691592|SUPERIORITY||||||<|0.001|||||||ANCOVA|Main effect of session using repeated measures ANCOVA covarying stimulation order||||||<.001
72581010|NCT01958437|144691592|SUPERIORITY|||||||0.046|||||||ANCOVA|Main effect of session using repeated measures ANCOVA covarying stimulation order||||||.046
72581011|NCT01958437|144691593|SUPERIORITY|||||||0.497|||||||ANCOVA|||Repeated Measures ANCOVA (covarying stimulation order)||||.497
72581012|NCT01958437|144691593|SUPERIORITY|||||||0.599|||||||ANCOVA|||||||.599
72581013|NCT04886596|144691602|OTHER|VE is demonstrated if the lower limit (LL) of the 2-sided confidence interval (CI) for vaccine efficacy (VE) is above 20%.|VE|82.58|||||TWO_SIDED|96.95|57.89|94.08|||Poisson regression method||VE in terms of occurrence of RSV-confirmed LRTD was evaluated using the conditional exact binomial method based on the Poisson model|To demonstrate the vaccine efficacy (VE) efficacy of a single dose of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD during the first season in adults ≥ 60 YOA||94.08|57.89|
72581014|NCT04886596|144691603|OTHER|VE is demonstrated if the LL of the 2-sided CI for VE is above 20%.|VE|62.91|||||TWO_SIDED|97.5|46.74|74.79|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (%) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To demonstrate the vaccine efficacy of a single dose of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD in adults ≥ 60 YOA over three seasons.||74.79|46.74|
72547107|NCT02978326|144623732|SUPERIORITY||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.18||0.0037|TWO_SIDED|95.0|-0.9|-0.2||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Depressed Mood: Change From Baseline in HAM-D Individual Item Score at Day 21||-0.2|-0.9|0.0037
72581015|NCT04886596|144691603|OTHER|VE is demonstrated if the LL of the 2-sided CI for VE is above 20%.|VE|67.18|||||TWO_SIDED|97.5|48.19|80.04|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (%) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To demonstrate the vaccine efficacy of a single dose of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD in adults ≥ 60 YOA over two seasons.||80.04|48.19|
72581016|NCT04886596|144691604|OTHER|VE is demonstrated if the LL of the 2-sided CI for VE is above 20%.|VE|67.76|||||TWO_SIDED|97.5|51.82|79.11|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (%) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To demonstrate the vaccine efficacy of a single dose of the RSVPreF3 OA investigational vaccine followed by 1 annual revaccination before Season 2 in the prevention of RSV-confirmed LRTD in adults ≥ 60 YOA over three seasons.||79.11|51.82|
72581017|NCT04886596|144691604|OTHER|VE is demonstrated if the LL of the 2-sided CI for VE is above 20%.|VE|67.12|||||TWO_SIDED|97.5|48.09|80.0|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (%) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To demonstrate the vaccine efficacy of a single dose of the RSVPreF3 OA investigational vaccine followed by 1 annual revaccination before Season 2 in the prevention of RSV-confirmed LRTD in adults ≥ 60 YOA over two seasons.||80.00|48.09|
72581018|NCT04886596|144691605|OTHER|VE is demonstrated if the LL of the 2-sided CI for VE is above 0%.|VE|69.83|||||TWO_SIDED|97.5|42.18|85.72|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To demonstrate the vaccine efficacy of a single dose of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD for RSV subtype A in adults ≥ 60 YOA over 3 seasons.||85.72|42.18|
72581019|NCT04886596|144691605|OTHER|VE is demonstrated if the LL of the 2-sided CI for VE is above 0%.|VE|58.57|||||TWO_SIDED|97.5|35.9|74.11|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To demonstrate the vaccine efficacy of a single dose of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD for RSV subtype B in adults ≥ 60 YOA over 3 seasons.||74.11|35.90|
72581020|NCT04886596|144691606|OTHER|VE is demonstrated if the LL of the 2-sided CI for VE is above 0%.|VE|55.12|||||TWO_SIDED|97.5|16.52|77.52|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To demonstrate the vaccine efficacy of a single dose and 1 annual revaccination before Season 2 of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD for RSV subtype A in adults ≥ 60 YOA over 3 seasons.||77.52|16.52|
72581021|NCT04886596|144691606|OTHER|VE is demonstrated if the LL of the 2-sided CI for VE is above 0%.|VE|73.58|||||TWO_SIDED|97.5|55.1|85.4|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To demonstrate the vaccine efficacy of a single dose and 1 annual revaccination before Season 2 of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD for RSV subtype B in adults ≥ 60 YOA over 3 seasons.||85.40|55.10|
72581022|NCT04886596|144691607|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|18.41|||||TWO_SIDED|95.0|-19.1|44.33|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season)|To evaluate vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of hMPV-confirmed LRTD in adults ≥ 60 YOA, following a single dose of the RSVPreF3 OA investigational vaccine up to the end of Season 1.||44.33|-19.10|
72581023|NCT04886596|144691608|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|58.78|||||TWO_SIDED|95.0|40.73|71.96|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD by \>=65YOA, following a single dose of the RSVPreF3 OA investigational vaccine.||71.96|40.73|
72581024|NCT04886596|144691608|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|65.98|||||TWO_SIDED|95.0|44.32|80.16|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD by \>=70YOA, following a single dose of the RSVPreF3 OA investigational vaccine.||80.16|44.32|
72581025|NCT04886596|144691608|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|36.24|||||TWO_SIDED|95.0|-93.99|82.47|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD by \>=80YOA, following a single dose of the RSVPreF3 OA investigational vaccine.||82.47|-93.99|
72581026|NCT04886596|144691608|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|66.56|||||TWO_SIDED|95.0|49.33|78.64|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD by \>=65YOA, following annual revaccination of the RSVPreF3 OA investigational vaccine.||78.64|49.33|
72581027|NCT04886596|144691608|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|64.25|||||TWO_SIDED|95.0|40.49|79.55|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD by \>=70YOA, following annual revaccination of the RSVPreF3 OA investigational vaccine at end of season 3.||79.55|40.49|
72581028|NCT04886596|144691608|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|32.81|||||TWO_SIDED|95.0|-108.42|81.73|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD by \>=80YOA, following annual revaccination of the RSVPreF3 OA investigational vaccine at end of season 3.||81.73|-108.42|
72581029|NCT04886596|144691609|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|80.64|||||TWO_SIDED|95.0|55.9|92.73|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, and region).|To evaluate the efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD over season 1 in adults ≥ 60 YOA, following a single dose of the RSVPreF3 OA investigational vaccine.||92.73|55.90|
72581030|NCT04886596|144691609|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|61.39|||||TWO_SIDED|95.0|36.44|77.7|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, and region).|To evaluate the efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD over season 2 in adults ≥ 60 YOA, following a single dose of the RSVPreF3 OA investigational vaccine.||77.70|36.44|
72547108|NCT02978326|144623732|SUPERIORITY||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.18||0.0061|TWO_SIDED|95.0|-0.8|-0.1||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Depressed Mood: Change From Baseline in HAM-D Individual Item Score at Day 45||-0.1|-0.8|0.0061
72581031|NCT04886596|144691609|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|47.15|||||TWO_SIDED|95.0|7.06|71.59|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, and region).|To evaluate the efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD over season 3 in adults ≥ 60 YOA, following a single dose of the RSVPreF3 OA investigational vaccine.||71.59|7.06|
72581032|NCT04886596|144691609|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|54.92|||||TWO_SIDED|95.0|27.85|72.98|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, and region).|To evaluate the efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD over season 2 in adults ≥ 60 YOA, following annual revaccination of the RSVPreF3 OA investigational vaccine.||72.98|27.85|
72581033|NCT04886596|144691609|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|67.51|||||TWO_SIDED|95.0|22.35|88.79|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, and region).|To evaluate the efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD over season 3 in adults ≥ 60 YOA, following annual revaccination of the RSVPreF3 OA investigational vaccine.||88.79|22.35|
72581034|NCT04886596|144691610|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|78.86|||||TWO_SIDED|95.0|57.62|90.48|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, and region).|To evaluate the efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD over Year 1 in adults ≥ 60 YOA, following a single dose of the RSVPreF3 OA investigational vaccine.||90.48|57.62|
72581035|NCT04886596|144691610|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|58.59|||||TWO_SIDED|95.0|34.0|75.1|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, and region).|To evaluate the efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD over Year 2 in adults ≥ 60 YOA, following a single dose of the RSVPreF3 OA investigational vaccine.||75.10|34.00|
72581036|NCT04886596|144691610|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|47.91|||||TWO_SIDED|95.0|8.51|71.97|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, and region).|To evaluate the efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD over Year 3 in adults ≥ 60 YOA, following a single dose of the RSVPreF3 OA investigational vaccine.||71.97|8.51|
72581037|NCT04886596|144691610|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|58.33|||||TWO_SIDED|95.0|33.59|74.94|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, and region).|To evaluate the efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD over Year 2 in adults ≥ 60 YOA, following annual revaccination of the RSVPreF3 OA investigational vaccine.||74.94|33.59|
72581038|NCT04886596|144691610|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|68.4|||||TWO_SIDED|95.0|24.64|89.08|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, and region).|To evaluate the efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD over Year 3 in adults ≥ 60 YOA, following annual revaccination of the RSVPreF3 OA investigational vaccine.||89.08|24.64|
72581039|NCT04886596|144691611|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|78.75|||||TWO_SIDED|95.0|57.95|89.26|||Regression, Cox||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (%) = Vaccine Efficacy (Piecewise Cox model with time-varying efficacy - adjusted by age and region).|To evaluate the evolution of efficacy of a single dose of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD in adults ≥ 60 YOA over Season 1.||89.26|57.95|
72412129|NCT02819726|144332237|OTHER||Difference (%)|1.3|STANDARD_ERROR_OF_MEAN|7.19|||TWO_SIDED|95.0|-12.59|15.1||||||Week 52 EULAR score 'Good'. EULAR (European League Against Rheumatism) response was classified using the individual amount of change in the DAS28-CRP score. The 95% CIs for EULAR response rate and treatment difference were derived using the Wilson Score method.||15.10|-12.59|
72547109|NCT02978326|144623732|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.16||0.7878|TWO_SIDED|95.0|-0.4|0.3||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Feelings of Guilt: Change From Baseline in HAM-D Individual Item Score at Day 3||0.3|-0.4|0.7878
72547110|NCT02978326|144623732|SUPERIORITY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.16||0.0498|TWO_SIDED|95.0|-0.6|0.0||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Feelings of Guilt: Change From Baseline in HAM-D Individual Item Score at Day 8||0.0|-0.6|0.0498
72581040|NCT04886596|144691611|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|67.63|||||TWO_SIDED|95.0|52.47|77.95|||Regression, Cox||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (%) = Vaccine Efficacy (Piecewise Cox model with time-varying efficacy - adjusted by age and region).|To evaluate the evolution of efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD in adults ≥ 60 YOA over Season 2, following a single dose of the RSVPreF3 OA investigational vaccine.||77.95|52.47|
72412130|NCT02819726|144332237|OTHER||Difference (%)|0.2|STANDARD_ERROR_OF_MEAN|7.21|||TWO_SIDED|95.0|-13.75|14.03|||Difference (%)|||Week 52 EULAR score 'Good'. EULAR (European League Against Rheumatism) response was classified using the individual amount of change in the DAS28-CRP score. The 95% CIs for EULAR response rate and treatment difference were derived using the Wilson Score method.||14.03|-13.75|
72547111|NCT02978326|144623732|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.16||0.1719|TWO_SIDED|95.0|-0.5|0.1||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Feelings of Guilt: Change From Baseline in HAM-D Individual Item Score at Day 15||0.1|-0.5|0.1719
72547112|NCT02978326|144623732|SUPERIORITY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.16||0.0161|TWO_SIDED|95.0|-0.7|-0.1||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Feelings of Guilt: Change From Baseline in HAM-D Individual Item Score at Day 21||-0.1|-0.7|0.0161
72547113|NCT02978326|144623732|SUPERIORITY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.15||0.0191|TWO_SIDED|95.0|-0.6|-0.1||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Feelings of Guilt: Change From Baseline in HAM-D Individual Item Score at Day 45||-0.1|-0.6|0.0191
72581041|NCT04886596|144691611|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|62.87|||||TWO_SIDED|95.0|46.76|74.11|||Regression, Cox||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (%) = Vaccine Efficacy (Piecewise Cox model with time-varying efficacy - adjusted by age and region).|To evaluate the evolution of efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD in adults ≥ 60 YOA over Season 3, following a single dose of the RSVPreF3 OA investigational vaccine.||74.11|46.76|
72581042|NCT04886596|144691611|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|67.49|||||TWO_SIDED|95.0|52.27|77.86|||Regression, Cox||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (%) = Vaccine Efficacy (Piecewise Cox model with time-varying efficacy - adjusted by age and region).|To evaluate the evolution of efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD in adults ≥ 60 YOA over Season 2, following annual revaccination of the RSVPreF3 OA investigational vaccine.||77.86|52.27|
72581043|NCT04886596|144691611|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|67.66|||||TWO_SIDED|95.0|51.71|78.34|||Regression, Cox||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (%) = Vaccine Efficacy (Piecewise Cox model with time-varying efficacy - adjusted by age and region).|To evaluate the evolution of efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD in adults ≥ 60 YOA over Season 3, following annual revaccination of the RSVPreF3 OA investigational vaccine.||78.34|51.71|
72581044|NCT04886596|144691612|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|66.49|||||TWO_SIDED|95.0|47.54|79.4|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD in adults ≥ 60 YOA by baseline comorbidities with low/medium risk (Charlson Comorbidity Index), following a single dose of the RSVPreF3 OA investigational vaccine.||79.40|47.54|
72547114|NCT02978326|144623732|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.06||0.2537|TWO_SIDED|95.0|-0.2|0.1||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Suicide: Change From Baseline in HAM-D Individual Item Score at Day 3||0.1|-0.2|0.2537
72547115|NCT02978326|144623732|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.04||0.0018|TWO_SIDED|95.0|-0.2|-0.1||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Suicide: Change From Baseline in HAM-D Individual Item Score at Day 8||-0.1|-0.2|0.0018
72547116|NCT02978326|144623732|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.05||0.2878|TWO_SIDED|95.0|-0.2|0.0||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Suicide: Change From Baseline in HAM-D Individual Item Score at Day 15||0.0|-0.2|0.2878
72547117|NCT02978326|144623732|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.07||0.2594|TWO_SIDED|95.0|-0.2|0.1||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Suicide: Change From Baseline in HAM-D Individual Item Score at Day 21||0.1|-0.2|0.2594
72547118|NCT02978326|144623732|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.06||0.0086|TWO_SIDED|95.0|-0.3|0.0||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Suicide: Change From Baseline in HAM-D Individual Item Score at Day 45||0.0|-0.3|0.0086
72547119|NCT02978326|144623732|SUPERIORITY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.14||0.0424|TWO_SIDED|95.0|-0.6|0.0||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Insomnia Early - Early Night: Change From Baseline in HAM-D Individual Item Score at Day 3||0.0|-0.6|0.0424
72547120|NCT02978326|144623732|SUPERIORITY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.14||0.0207|TWO_SIDED|95.0|-0.6|0.0||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Insomnia Early - Early Night: Change From Baseline in HAM-D Individual Item Score at Day 8||0.0|-0.6|0.0207
72547121|NCT02978326|144623732|SUPERIORITY||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.14||0.001|TWO_SIDED|95.0|-0.7|-0.2||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Insomnia Early - Early Night: Change From Baseline in HAM-D Individual Item Score at Day 15||-0.2|-0.7|0.0010
72547122|NCT02978326|144623732|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.14||0.0871|TWO_SIDED|95.0|-0.5|0.0||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Insomnia Early - Early Night: Change From Baseline in HAM-D Individual Item Score at Day 21||0.0|-0.5|0.0871
72547123|NCT02978326|144623732|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.15||0.568|TWO_SIDED|95.0|-0.4|0.2||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Insomnia Early - Early Night: Change From Baseline in HAM-D Individual Item Score at Day 45||0.2|-0.4|0.5680
72547124|NCT02978326|144623732|SUPERIORITY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.14||0.0143|TWO_SIDED|95.0|-0.6|-0.1||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Insomnia Middle - Middle Night: Change From Baseline in HAM-D Individual Item Score at Day 3||-0.1|-0.6|0.0143
72547125|NCT02978326|144623732|SUPERIORITY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.13||0.0063|TWO_SIDED|95.0|-0.6|-0.1||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Insomnia Middle - Middle Night: Change From Baseline in HAM-D Individual Item Score at Day 8||-0.1|-0.6|0.0063
72547126|NCT02978326|144623732|SUPERIORITY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.13||0.0042|TWO_SIDED|95.0|-0.6|-0.1||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Insomnia Middle - Middle Night: Change From Baseline in HAM-D Individual Item Score at Day 15||-0.1|-0.6|0.0042
72581045|NCT04886596|144691612|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|58.88|||||TWO_SIDED|95.0|34.81|74.98|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD in adults ≥ 60 YOA by baseline comorbidities with high risk (Charlson Comorbidity Index), following a single dose of the RSVPreF3 OA investigational vaccine.||74.98|34.81|
72581046|NCT04886596|144691612|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|72.55|||||TWO_SIDED|95.0|54.34|84.37|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD in adults ≥ 60 YOA by baseline comorbidities with low/medium risk (Charlson Comorbidity Index), following annual revaccination of the RSVPreF3 OA investigational vaccine.||84.37|54.34|
72581047|NCT04886596|144691612|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|61.99|||||TWO_SIDED|95.0|37.17|78.01|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD in adults ≥ 60 YOA by baseline comorbidities with high risk (Charlson Comorbidity Index), following annual revaccination of the RSVPreF3 OA investigational vaccine.||78.01|37.17|
72581048|NCT04886596|144691613|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|61.48|||||TWO_SIDED|95.0|38.62|76.74|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD in adults ≥ 60 YOA with no pre-existing comorbidity of interest, following a single dose of the RSVPreF3 OA investigational vaccine.||76.74|38.62|
72547127|NCT02978326|144623732|SUPERIORITY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.13||0.0137|TWO_SIDED|95.0|-0.6|-0.1||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Insomnia Middle - Middle Night: Change From Baseline in HAM-D Individual Item Score at Day 21||-0.1|-0.6|0.0137
72547128|NCT02978326|144623732|SUPERIORITY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.14||0.0099|TWO_SIDED|95.0|-0.6|-0.1||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Insomnia Middle - Middle Night: Change From Baseline in HAM-D Individual Item Score at Day 45||-0.1|-0.6|0.0099
72547129|NCT02978326|144623732|SUPERIORITY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.14||0.0507|TWO_SIDED|95.0|-0.5|0.0||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Insomnia Early Hours - Morning: Change From Baseline in HAM-D Individual Item Score at Day 3||0.0|-0.5|0.0507
72547130|NCT02978326|144623732|SUPERIORITY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.13||0.0205|TWO_SIDED|95.0|-0.5|0.0||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Insomnia Early Hours - Morning: Change From Baseline in HAM-D Individual Item Score at Day 8||0.0|-0.5|0.0205
72547131|NCT02978326|144623732|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.13||0.1409|TWO_SIDED|95.0|-0.5|0.1||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Insomnia Early Hours - Morning: Change From Baseline in HAM-D Individual Item Score at Day 15||0.1|-0.5|0.1409
72547132|NCT02978326|144623732|SUPERIORITY|MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.14||0.2021|TWO_SIDED|95.0|-0.5|0.1|||Mixed Model for Repeated Measures|||Insomnia Early Hours - Morning: Change From Baseline in HAM-D Individual Item Score at Day 21||0.1|-0.5|0.2021
72581049|NCT04886596|144691613|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|64.73|||||TWO_SIDED|95.0|45.1|78.14|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD in adults ≥ 60 YOA with at least 1 pre-existing comorbidity of interest, following a single dose of the RSVPreF3 OA investigational vaccine.||78.14|45.10|
72581050|NCT04886596|144691613|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|68.14|||||TWO_SIDED|95.0|45.71|82.33|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD in adults ≥ 60 YOA with at least 1 pre-existing cardiorespiratory condition, following a single dose of the RSVPreF3 OA investigational vaccine.||82.33|45.71|
72547133|NCT02978326|144623732|SUPERIORITY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.12||0.0117|TWO_SIDED|95.0|-0.6|-0.1||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Insomnia Early Hours - Morning: Change From Baseline in HAM-D Individual Item Score at Day 45||-0.1|-0.6|0.0117
72547134|NCT02978326|144623732|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.15||0.5511|TWO_SIDED|95.0|-0.4|0.2||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Work and Activities: Change From Baseline in HAM-D Individual Item Score at Day 3||0.2|-0.4|0.5511
72547135|NCT02978326|144623732|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.18||0.4949|TWO_SIDED|95.0|-0.5|0.2||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Work and Activities: Change From Baseline in HAM-D Individual Item Score at Day 8||0.2|-0.5|0.4949
72547136|NCT02978326|144623732|SUPERIORITY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.17||0.0203|TWO_SIDED|95.0|-0.7|-0.1||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Work and Activities: Change From Baseline in HAM-D Individual Item Score at Day 15||-0.1|-0.7|0.0203
72581051|NCT04886596|144691613|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|63.88|||||TWO_SIDED|95.0|31.35|82.48|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD in adults ≥ 60 YOA with at least 1 pre-existing endocrinometabolic condition, following a single dose of the RSVPreF3 OA investigational vaccine.||82.48|31.35|
72581052|NCT04886596|144691613|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|64.16|||||TWO_SIDED|95.0|41.08|79.17|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD in adults ≥ 60 YOA with no pre-existing comorbidity of interest, following annual revaccination of the RSVPreF3 OA investigational vaccine.||79.17|41.08|
72581053|NCT04886596|144691613|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|71.19|||||TWO_SIDED|95.0|51.92|83.65|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD in adults ≥ 60 YOA with at least 1 pre-existing comorbidity of interest, following annual revaccination of the RSVPreF3 OA investigational vaccine.||83.65|51.92|
72581054|NCT04886596|144691613|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|75.94|||||TWO_SIDED|95.0|54.11|88.54|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD in adults ≥ 60 YOA with at least 1 pre-existing cardiorespiratory condition,following annual revaccination of the RSVPreF3 OA investigational vaccine.||88.54|54.11|
72581055|NCT04886596|144691613|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|69.85|||||TWO_SIDED|95.0|37.51|87.05|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD in adults ≥ 60 YOA with at least 1 pre-existing endocrinometabolic condition, following annual revaccination of the RSVPreF3 OA investigational vaccine.||87.05|37.51|
72581056|NCT04886596|144691614|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|-153.57|||||TWO_SIDED|95.0|-16322.97|88.0|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD by baseline frailty status (frail) in adults ≥ 60 YOA, following a single dose of the RSVPreF3 OA investigational vaccine.||88.00|-16322.97|
72581057|NCT04886596|144691614|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|70.07|||||TWO_SIDED|95.0|43.89|85.33|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD by baseline frailty status (pre-frail) in adults ≥ 60 YOA, following a single dose of the RSVPreF3 OA investigational vaccine.||85.33|43.89|
72581058|NCT04886596|144691614|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|61.04|||||TWO_SIDED|95.0|42.89|74.08|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD by baseline frailty status (fit) in adults ≥ 60 YOA, following a single dose of the RSVPreF3 OA investigational vaccine.||74.08|42.89|
72547137|NCT02978326|144623732|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.19||0.2076|TWO_SIDED|95.0|-0.6|0.1||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Work and Activities: Change From Baseline in HAM-D Individual Item Score at Day 21||0.1|-0.6|0.2076
72547138|NCT02978326|144623732|SUPERIORITY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.19||0.0362|TWO_SIDED|95.0|-0.8|0.0||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Work and Activities: Change From Baseline in HAM-D Individual Item Score at Day 45||0.0|-0.8|0.0362
72547139|NCT02978326|144623732|SUPERIORITY||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.12||0.3589|TWO_SIDED|95.0|-0.1|0.3||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Retardation: Change From Baseline in HAM-D Individual Item Score at Day 3||0.3|-0.1|0.3589
72547140|NCT02978326|144623732|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.1||0.6991|TWO_SIDED|95.0|-0.2|0.2||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Retardation: Change From Baseline in HAM-D Individual Item Score at Day 8||0.2|-0.2|0.6991
72547141|NCT02978326|144623732|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.1||0.9655|TWO_SIDED|95.0|-0.2|0.2||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Retardation: Change From Baseline in HAM-D Individual Item Score at Day 15||0.2|-0.2|0.9655
72547142|NCT02978326|144623732|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.1||0.8699|TWO_SIDED|95.0|-0.2|0.2||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Retardation: Change From Baseline in HAM-D Individual Item Score at Day 21||0.2|-0.2|0.8699
72547143|NCT02978326|144623732|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.09||0.3715|TWO_SIDED|95.0|-0.3|0.1||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Retardation: Change From Baseline in HAM-D Individual Item Score at Day 45||0.1|-0.3|0.3715
72547144|NCT02978326|144623732|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.12||0.067|TWO_SIDED|95.0|-0.4|0.0||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Agitation: Change From Baseline in HAM-D Individual Item Score at Day 3||0.0|-0.4|0.0670
72547145|NCT02978326|144623732|SUPERIORITY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.11||0.0104|TWO_SIDED|95.0|-0.5|-0.1||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Agitation: Change From Baseline in HAM-D Individual Item Score at Day 8||-0.1|-0.5|0.0104
72547146|NCT02978326|144623732|SUPERIORITY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.12||0.0122|TWO_SIDED|95.0|-0.5|-0.1||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Agitation: Change From Baseline in HAM-D Individual Item Score at Day 15||-0.1|-0.5|0.0122
72547147|NCT02978326|144623732|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.12||0.3157|TWO_SIDED|95.0|-0.3|0.1||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Agitation: Change From Baseline in HAM-D Individual Item Score at Day 21||0.1|-0.3|0.3157
72547148|NCT02978326|144623732|SUPERIORITY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.11||0.0077|TWO_SIDED|95.0|-0.5|-0.1||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Agitation: Change From Baseline in HAM-D Individual Item Score at Day 45||-0.1|-0.5|0.0077
72547149|NCT02978326|144623732|SUPERIORITY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.16||0.0078|TWO_SIDED|95.0|-0.8|-0.1||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Anxiety Psychic: Change From Baseline in HAM-D Individual Item Score at Day 3||-0.1|-0.8|0.0078
72547150|NCT02978326|144623732|SUPERIORITY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.18||0.0372|TWO_SIDED|95.0|-0.7|0.0||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Anxiety Psychic: Change From Baseline in HAM-D Individual Item Score at Day 8||0.0|-0.7|0.0372
72547151|NCT02978326|144623732|SUPERIORITY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.17||0.0244|TWO_SIDED|95.0|-0.7|-0.1||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Anxiety Psychic: Change From Baseline in HAM-D Individual Item Score at Day 15||-0.1|-0.7|0.0244
72412131|NCT02819726|144332237|OTHER||Difference (%)|-1.1|STANDARD_ERROR_OF_MEAN|7.29|||TWO_SIDED|95.0|-15.14|12.91||||||Week 52 EULAR score 'Good'. EULAR (European League Against Rheumatism) response was classified using the individual amount of change in the DAS28-CRP score. The 95% CIs for EULAR response rate and treatment difference were derived using the Wilson Score method.||12.91|-15.14|
72547152|NCT02978326|144623732|SUPERIORITY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.17||0.0993|TWO_SIDED|95.0|-0.6|0.1||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Anxiety Psychic: Change From Baseline in HAM-D Individual Item Score at Day 21||0.1|-0.6|0.0993
72547153|NCT02978326|144623732|SUPERIORITY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.17||0.0185|TWO_SIDED|95.0|-0.7|-0.1||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Anxiety Psychic: Change From Baseline in HAM-D Individual Item Score at Day 45||-0.1|-0.7|0.0185
72547154|NCT02978326|144623732|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.12||0.2471|TWO_SIDED|95.0|-0.4|0.1||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Anxiety Somatic: Change From Baseline in HAM-D Individual Item Score at Day 3||0.1|-0.4|0.2471
72547155|NCT02978326|144623732|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.14||0.1076|TWO_SIDED|95.0|-0.5|0.0||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Anxiety Somatic: Change From Baseline in HAM-D Individual Item Score at Day 8||0.0|-0.5|0.1076
72547156|NCT02978326|144623732|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.14||0.2782|TWO_SIDED|95.0|-0.4|0.1||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Anxiety Somatic: Change From Baseline in HAM-D Individual Item Score at Day 15||0.1|-0.4|0.2782
72547157|NCT02978326|144623732|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.15||0.4646|TWO_SIDED|95.0|-0.4|0.2|||Mixed Model for Repeated Measures|||Anxiety Somatic: Change From Baseline in HAM-D Individual Item Score at Day 21||0.2|-0.4|0.4646
72412132|NCT02819726|144332243|OTHER|Statistical comparison of CD19+ B-cell pharmacokinetic parameters at Day 15 \[AUEC(0-d15)\]|Statistical Comparisons Difference|22.1|||||TWO_SIDED|90.0|-137.1|181.3||||||The statistical comparison of the between treatments is based on an analysis of covariance (ANOVA) model with fixed effect for treatment and a covariate for baseline value.||181.3|-137.1|
72547158|NCT02978326|144623732|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.14||0.16|TWO_SIDED|95.0|-0.5|0.1||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Anxiety Somatic: Change From Baseline in HAM-D Individual Item Score at Day 45||0.1|-0.5|0.1600
72547159|NCT02978326|144623732|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.12||0.0474|TWO_SIDED|95.0|-0.5|0.0||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Somatic Symptoms Gastrointestinal: Change From Baseline in HAM-D Individual Item Score at Day 3||0.0|-0.5|0.0474
72412133|NCT02819726|144332243|OTHER|Statistical comparison of CD19+ B-cell pharmacokinetic parameters at Day 15 \[AUEC(0-d15)\]|Statistical Comparisons Difference|69.5|||||TWO_SIDED|90.0|-91.8|230.8||||||The statistical comparison of the between treatments is based on an analysis of covariance (ANOVA) model with fixed effect for treatment and a covariate for baseline value.||230.8|-91.8|
72581059|NCT04886596|144691614|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|13.62|||||TWO_SIDED|95.0|-6751.38|98.91|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD by baseline frailty status (frail) in adults ≥ 60 YOA, following annual revaccination of the RSVPreF3 OA investigational vaccine.||98.91|-6751.38|
72581060|NCT04886596|144691614|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|74.32|||||TWO_SIDED|95.0|49.33|88.31|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD by baseline frailty status (pre-frail) in adults ≥ 60 YOA, following annual revaccination of the RSVPreF3 OA investigational vaccine.||88.31|49.33|
72581061|NCT04886596|144691614|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|64.79|||||TWO_SIDED|95.0|46.1|77.75|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD by baseline frailty status (fit) in adults ≥ 60 YOA, following annual revaccination of the RSVPreF3 OA investigational vaccine.||77.75|46.10|
72581062|NCT04886596|144691615|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|67.38|||||TWO_SIDED|95.0|42.43|82.68|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of severe RSV-confirmed LRTD in adults ≥ 60 YOA according to any case definition, following a single dose of the RSVPreF3 OA investigational vaccine.||82.68|42.43|
72581063|NCT04886596|144691615|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|67.38|||||TWO_SIDED|95.0|42.43|82.68|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of severe RSV-confirmed LRTD in adults ≥ 60 YOA according to case definition 1, following a single dose of the RSVPreF3 OA investigational vaccine.||82.68|42.43|
72581064|NCT04886596|144691615|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|59.16|||||TWO_SIDED|95.0|-119.6|95.93|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of severe RSV-confirmed LRTD in adults ≥ 60 YOA according to the case definition 2, following a single dose of the RSVPreF3 OA investigational vaccine.||95.93|-119.60|
72581065|NCT04886596|144691615|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|78.8|||||TWO_SIDED|95.0|57.05|90.75|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of severe RSV-confirmed LRTD in adults ≥ 60 YOA according to any case definition, following annual revaccination of the RSVPreF3 OA investigational vaccine.||90.75|57.05|
72581066|NCT04886596|144691615|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|78.8|||||TWO_SIDED|95.0|57.05|90.75|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of severe RSV-confirmed LRTD in adults ≥ 60 YOA according to case definition 1, following annual revaccination of the RSVPreF3 OA investigational vaccine.||90.75|57.05|
72581067|NCT04886596|144691615|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|100.0|||||TWO_SIDED|95.0|20.27|100.0|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of severe RSV-confirmed LRTD in adults ≥ 60 YOA according to case definition 2, following annual revaccination of the RSVPreF3 OA investigational vaccine.||100.00|20.27|
72581068|NCT04886596|144691616|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|51.13|||||TWO_SIDED|95.0|40.31|60.21|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed ARI in adults ≥ 60 YOA, following a single dose of the RSVPreF3 OA investigational vaccine.||60.21|40.31|
72412134|NCT02819726|144332243|OTHER|Statistical comparison of CD19+ B-cell pharmacokinetic parameters at Day 15 \[AUEC(0-d15)\]|Statistical Comparisons Difference|47.4|||||TWO_SIDED|90.0|-112.5|207.2||||||The statistical comparison of the between treatments is based on an analysis of covariance (ANOVA) model with fixed effect for treatment and a covariate for baseline value.||207.2|-112.5|
72412135|NCT02819726|144332243|OTHER|Statistical comparison of CD19+ B-cell pharmacokinetic parameters at Day week \[AUEC(0-w24)\]|Statistical Comparisons Difference|310.7|||||TWO_SIDED|90.0|-187.9|809.4||||||The statistical comparison of the between treatments is based on an analysis of covariance (ANOVA) model with fixed effect for treatment and a covariate for baseline value.||809.4|-187.9|
72547160|NCT02978326|144623732|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.12||0.0446|TWO_SIDED|95.0|-0.5|0.0||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Somatic Symptoms Gastrointestinal: Change From Baseline in HAM-D Individual Item Score at Day 8||0.0|-0.5|0.0446
72547161|NCT02978326|144623732|SUPERIORITY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.12||0.0093|TWO_SIDED|95.0|-0.6|-0.1||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Somatic Symptoms Gastrointestinal: Change From Baseline in HAM-D Individual Item Score at Day 15||-0.1|-0.6|0.0093
72547162|NCT02978326|144623732|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.12||0.2998|TWO_SIDED|95.0|-0.4|0.1||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Somatic Symptoms Gastrointestinal: Change From Baseline in HAM-D Individual Item Score at Day 21||0.1|-0.4|0.2998
72547163|NCT02978326|144623732|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.12||0.0545|TWO_SIDED|95.0|-0.5|0.0||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Somatic Symptoms Gastrointestinal: Change From Baseline in HAM-D Individual Item Score at Day 45||0.0|-0.5|0.0545
72547164|NCT02978326|144623732|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.12||0.2177|TWO_SIDED|95.0|-0.4|0.1||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||General Somatic Symptoms: Change From Baseline in HAM-D Individual Item Score at Day 3||0.1|-0.4|0.2177
72547165|NCT02978326|144623732|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.12||0.23|TWO_SIDED|95.0|-0.4|0.1||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||General Somatic Symptoms: Change From Baseline in HAM-D Individual Item Score at Day 8||0.1|-0.4|0.2300
72581069|NCT04886596|144691616|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|58.44|||||TWO_SIDED|95.0|48.1|66.96|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed ARI in adults ≥ 60 YOA, following annual revaccination of the RSVPreF3 OA investigational vaccine.||66.96|48.10|
72412136|NCT02819726|144332243|OTHER|Statistical comparison of CD19+ B-cell pharmacokinetic parameters at Day week \[AUEC(0-w24)\]|Statistical Comparisons Difference|296.1|||||TWO_SIDED|90.0|-213.8|806.1||||||The statistical comparison of the between treatments is based on an analysis of covariance (ANOVA) model with fixed effect for treatment and a covariate for baseline value.||806.1|-213.8|
72581070|NCT04886596|144691617|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|2.33|||||TWO_SIDED|95.0|-1.47|5.99|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of any ARI in adults ≥ 60 YOA, following a single dose of the RSVPreF3 OA investigational vaccine.||5.99|-1.47|
72581071|NCT04886596|144691617|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|3.32|||||TWO_SIDED|95.0|-0.5|6.98|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of any ARI in adults ≥ 60 YOA, following annual revaccination of the RSVPreF3 OA investigational vaccine.||6.98|-0.50|
72547166|NCT02978326|144623732|SUPERIORITY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.12||0.0001|TWO_SIDED|95.0|-0.7|-0.2||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||General Somatic Symptoms: Change From Baseline in HAM-D Individual Item Score at Day 15||-0.2|-0.7|0.0001
72547167|NCT02978326|144623732|SUPERIORITY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.12||0.0151|TWO_SIDED|95.0|-0.5|-0.1||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||General Somatic Symptoms: Change From Baseline in HAM-D Individual Item Score at Day 21||-0.1|-0.5|0.0151
72547168|NCT02978326|144623732|SUPERIORITY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.13||0.0502|TWO_SIDED|95.0|-0.5|0.0|||Mixed Model for Repeated Measures|||General Somatic Symptoms: Change From Baseline in HAM-D Individual Item Score at Day 45||0.0|-0.5|0.0502
72547169|NCT02978326|144623732|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.11||0.3659|TWO_SIDED|95.0|-0.3|0.1||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Genital Symptoms: Change From Baseline in HAM-D Individual Item Score at Day 3||0.1|-0.3|0.3659
72412137|NCT02819726|144332243|OTHER|Statistical comparison of CD19+ B-cell pharmacokinetic parameters at Day week \[AUEC(0-w24)\]|Statistical Comparisons Difference|-14.6|||||TWO_SIDED|90.0|-527.4|498.2||||||The statistical comparison of the between treatments is based on an analysis of covariance (ANOVA) model with fixed effect for treatment and a covariate for baseline value.||498.2|-527.4|
72547170|NCT02978326|144623732|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.12||0.6003|TWO_SIDED|95.0|-0.3|0.2||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Genital Symptoms: Change From Baseline in HAM-D Individual Item Score at Day 8||0.2|-0.3|0.6003
72547171|NCT02978326|144623732|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.13||0.0785|TWO_SIDED|95.0|-0.5|0.0||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Genital Symptoms: Change From Baseline in HAM-D Individual Item Score at Day 15||0.0|-0.5|0.0785
72547172|NCT02978326|144623732|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.13||0.3668|TWO_SIDED|95.0|-0.4|0.1||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Genital Symptoms: Change From Baseline in HAM-D Individual Item Score at Day 21||0.1|-0.4|0.3668
72547173|NCT02978326|144623732|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.13||0.1827|TWO_SIDED|95.0|-0.4|0.1||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Genital Symptoms: Change From Baseline in HAM-D Individual Item Score at Day 45||0.1|-0.4|0.1827
72547174|NCT02978326|144623732|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.12||0.1327|TWO_SIDED|95.0|-0.4|0.1||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Hypochondriasis: Change From Baseline in HAM-D Individual Item Score at Day 3||0.1|-0.4|0.1327
72547175|NCT02978326|144623732|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.11||0.0993|TWO_SIDED|95.0|-0.4|0.0||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Hypochondriasis: Change From Baseline in HAM-D Individual Item Score at Day 8||0.0|-0.4|0.0993
72547176|NCT02978326|144623732|SUPERIORITY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.11||0.0002|TWO_SIDED|95.0|-0.6|-0.2||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Hypochondriasis: Change From Baseline in HAM-D Individual Item Score at Day 15||-0.2|-0.6|0.0002
72581072|NCT04886596|144691617|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|3.68|||||TWO_SIDED|95.0|-1.55|8.63|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of any LRTD in adults ≥ 60 YOA, following a single dose of the RSVPreF3 OA investigational vaccine.||8.63|-1.55|
72581073|NCT04886596|144691617|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|6.99|||||TWO_SIDED|95.0|1.81|11.9|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of any LRTD in adults ≥ 60 YOA, following annual revaccination of the RSVPreF3 OA investigational vaccine.||11.90|1.81|
72581074|NCT04886596|144691618|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|50.37|||||TWO_SIDED|95.0|-184.45|95.19|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of hospitalization due to RT-PCR-confirmed RSV respiratory disease during the study period in adults ≥ 60 YOA, following a single dose of the RSVPreF3 OA investigational vaccine.||95.19|-184.45|
72581075|NCT04886596|144691618|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|50.37|||||TWO_SIDED|95.0|-184.45|95.19|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of hospitalization due to RT-PCR-confirmed RSV respiratory disease or complication related to RT-PCR-confirmed RSV ARI during the study period in adults ≥ 60 YOA, following a single dose of the RSVPreF3 OA investigational vaccine.||95.19|-184.45|
72581076|NCT04886596|144691618|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|100.0|||||TWO_SIDED|95.0|11.56|100.0|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of hospitalization due to RT-PCR-confirmed RSV respiratory disease during the study period in adults ≥ 60 YOA, following annual revaccination of the RSVPreF3 OA investigational vaccine.||100.00|11.56|
72581077|NCT04886596|144691618|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|100.0|||||TWO_SIDED|95.0|11.56|100.0|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of hospitalization due to RT-PCR-confirmed RSV respiratory disease or complication related to RT-PCR-confirmed RSV ARI during the study period in adults ≥ 60 YOA, following annual revaccination of the RSVPreF3 OA investigational vaccine.||100.00|11.56|
72581078|NCT04886596|144691618|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|22.14|||||TWO_SIDED|95.0|-457.67|93.12|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of hospitalization due to RT-PCR-confirmed RSV respiratory disease during the RSV seson in adults ≥ 60 YOA, following a single dose of the RSVPreF3 OA investigational vaccine.||93.12|-457.67|
72581079|NCT04886596|144691618|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|22.14|||||TWO_SIDED|95.0|-457.67|93.12|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of hospitalization due to RT-PCR-confirmed RSV respiratory disease or complication related to RT-PCR-confirmed RSV ARI during the RSV season in adults ≥ 60 YOA, following a single dose of the RSVPreF3 OA investigational vaccine.||93.12|-457.67|
72581080|NCT04886596|144691618|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|100.0|||||TWO_SIDED|95.0|-54.53|100.0|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of hospitalization due to RT-PCR-confirmed RSV respiratory disease during the RSV season in adults ≥ 60 YOA, following annual revaccination of the RSVPreF3 OA investigational vaccine.||100.00|-54.53|
72581081|NCT04886596|144691618|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|100.0|||||TWO_SIDED|95.0|-54.53|100.0|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of hospitalization due to RT-PCR-confirmed RSV respiratory disease or complication related to RT-PCR-confirmed RSV ARI during the RSV season in adults ≥ 60 YOA, following annual revaccination of the RSVPreF3 OA investigational vaccine.||100.00|-54.53|
72581082|NCT04886596|144691619|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|-1.81|||||TWO_SIDED|95.0|-25.43|17.49|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of hospitalization due to any respiratory diseases during the study period in adults ≥ 60 YOA, following a single dose of the RSVPreF3 OA investigational vaccine.||17.49|-25.43|
72581083|NCT04886596|144691619|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|-4.72|||||TWO_SIDED|95.0|-28.26|14.61|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of hospitalization due to any respiratory diseases or complication related to any respiratory disease during the study period in adults ≥ 60 YOA, following a single dose of the RSVPreF3 OA investigational vaccine.||14.61|-28.26|
72547177|NCT02978326|144623732|SUPERIORITY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.1||0.0056|TWO_SIDED|95.0|-0.5|-0.1||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Hypochondriasis: Change From Baseline in HAM-D Individual Item Score at Day 21||-0.1|-0.5|0.0056
72547178|NCT02978326|144623732|SUPERIORITY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.11||0.0122|TWO_SIDED|95.0|-0.5|-0.1||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Hypochondriasis: Change From Baseline in HAM-D Individual Item Score at Day 45||-0.1|-0.5|0.0122
72547179|NCT02978326|144623732|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.1||0.1305|TWO_SIDED|95.0|-0.3|0.0||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Loss of Weight According to Patient: Change From Baseline in HAM-D Individual Item Score at Day 3||0.0|-0.3|0.1305
72581084|NCT04886596|144691619|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|-3.61|||||TWO_SIDED|95.0|-28.2|16.38|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of hospitalization due to any respiratory diseases during the study period in adults ≥ 60 YOA, following annual revaccination of the RSVPreF3 OA investigational vaccine||16.38|-28.20|
72547180|NCT02978326|144623732|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.09||0.6638|TWO_SIDED|95.0|-0.2|0.1||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Loss of Weight According to Patient: Change From Baseline in HAM-D Individual Item Score at Day 8||0.1|-0.2|0.6638
72547181|NCT02978326|144623732|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.08||0.4341|TWO_SIDED|95.0|-0.2|0.1||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Loss of Weight According to Patient: Change From Baseline in HAM-D Individual Item Score at Day 15||0.1|-0.2|0.4341
72547182|NCT02978326|144623732|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.07||0.9085|TWO_SIDED|95.0|-0.1|0.1||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Loss of Weight According to Patient: Change From Baseline in HAM-D Individual Item Score at Day 21||0.1|-0.1|0.9085
72581085|NCT04886596|144691619|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|-3.59|||||TWO_SIDED|95.0|-27.55|15.98|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of hospitalization due to any respiratory diseases or complication related to any respiratory diseases during the study period in adults ≥ 60 YOA, following annual revaccination of the RSVPreF3 OA investigational vaccine.||15.98|-27.55|
72581086|NCT04886596|144691619|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|2.98|||||TWO_SIDED|95.0|-23.52|23.99|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of hospitalization due to any respiratory diseases during the RSV season in adults ≥ 60 YOA, following a single dose of the RSVPreF3 OA investigational vaccine.||23.99|-23.52|
72581087|NCT04886596|144691619|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|-1.71|||||TWO_SIDED|95.0|-28.56|19.7|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of hospitalization due to any respiratory diseases or complication related to any respiratory disease during the RSV seasons in adults ≥ 60 YOA, following a single dose of the RSVPreF3 OA investigational vaccine.||19.70|-28.56|
72581088|NCT04886596|144691619|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|4.8|||||TWO_SIDED|95.0|-22.14|26.0|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of hospitalization due to any respiratory diseases during the RSV seasons in adults ≥ 60 YOA, following annual revaccination of the RSVPreF3 OA investigational vaccine.||26.00|-22.14|
72581089|NCT04886596|144691619|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|4.64|||||TWO_SIDED|95.0|-21.73|25.48|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of hospitalization due to any respiratory diseases or complication related to any respiratory diseases during the RSV seasons in adults ≥ 60 YOA, following annual revaccination of the RSVPreF3 OA investigational vaccine.||25.48|-21.73|
72547183|NCT02978326|144623732|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.09||0.182|TWO_SIDED|95.0|-0.3|0.1||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Loss of Weight According to Patient: Change From Baseline in HAM-D Individual Item Score at Day 45||0.1|-0.3|0.1820
72547184|NCT02978326|144623732|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.03||0.1593|TWO_SIDED|95.0|-0.1|0.0||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Insight: Change From Baseline in HAM-D Individual Item Score at Day 3||0.0|-0.1|0.1593
72547185|NCT02978326|144623732|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.03||0.6555|TWO_SIDED|95.0|-0.1|0.0||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Insight: Change From Baseline in HAM-D Individual Item Score at Day 8||0.0|-0.1|0.6555
72547186|NCT02978326|144623732|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.03||0.017|TWO_SIDED|95.0|-0.1|0.0||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Insight: Change From Baseline in HAM-D Individual Item Score at Day 15||0.0|-0.1|0.0170
72547187|NCT02978326|144623732|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.03||0.0188|TWO_SIDED|95.0|-0.1|0.0||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Insight: Change From Baseline in HAM-D Individual Item Score at Day 21||0.0|-0.1|0.0188
72547188|NCT02978326|144623732|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.05||0.0726|TWO_SIDED|95.0|-0.2|0.0||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Insight: Change From Baseline in HAM-D Individual Item Score at Day 45||0.0|-0.2|0.0726
72581090|NCT04886596|144691620|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|62.94|||||TWO_SIDED|95.0|28.91|82.15|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of complications related to RSV- ARI during the study period in adults ≥ 60 YOA, following a single dose of the RSVPreF3 OA investigational vaccine.||82.15|28.91|
72581091|NCT04886596|144691620|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|63.8|||||TWO_SIDED|95.0|28.5|83.2|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of complications related to RSV-ARI during the study period in adults ≥ 60 YOA, following annual revaccination of the RSVPreF3 OA investigational vaccine.||83.20|28.50|
72547189|NCT02978326|144623733|SUPERIORITY||LS Mean Difference|-3.0|STANDARD_ERROR_OF_MEAN|1.72||0.0791|TWO_SIDED|95.0|-6.5|0.4||MMRM was used for estimation with treatment with treatment, baseline MADRS total score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Change From Baseline in MADRS Total Score at Day 3||0.4|-6.5|0.0791
72547190|NCT02978326|144623733|SUPERIORITY||LS Mean Difference|-4.0|STANDARD_ERROR_OF_MEAN|1.86||0.0322|TWO_SIDED|1.86|-7.7|-0.3||MMRM was used for estimation with treatment with treatment, baseline MADRS total score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Change From Baseline in MADRS Total Score at Day 8||-0.3|-7.7|0.0322
72547191|NCT02978326|144623733|SUPERIORITY||LS Mean Difference|-4.6|STANDARD_ERROR_OF_MEAN|1.91||0.018|TWO_SIDED|95.0|-8.3|-0.8||MMRM was used for estimation with treatment with treatment, baseline MADRS total score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Change From Baseline in MADRS Total Score at Day 15||-0.8|-8.3|0.0180
72547192|NCT02978326|144623733|SUPERIORITY||LS Mean Difference|-4.3|STANDARD_ERROR_OF_MEAN|1.92||0.0271|TWO_SIDED|95.0|-8.1|-0.5||MMRM was used for estimation with treatment with treatment, baseline MADRS total score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Change from Baseline in MADRS Total Score at 21||-0.5|-8.1|0.0271
72547193|NCT02978326|144623733|SUPERIORITY||LS Mean Difference|-5.8|STANDARD_ERROR_OF_MEAN|1.82||0.0018|TWO_SIDED|95.0|-9.4|-2.2||MMRM was used for estimation with treatment with treatment, baseline MADRS total score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Change from Baseline in MADRS Total Score at 45||-2.2|-9.4|0.0018
72547194|NCT02978326|144623734|SUPERIORITY||Odds Ratio (OR)|1.4||||0.3372|TWO_SIDED|95.0|0.7|2.81||Generalized estimating equations for binary response model was used for estimation with factors for treatment, baseline CGI-S score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction.|GEE for binary response model|||Percentage of Participants With CGI-I Response at Day 3||2.81|0.70|0.3372
72547195|NCT02978326|144623734|SUPERIORITY||Odds Ratio (OR)|1.77||||0.0935|TWO_SIDED|95.0|0.91|3.47||Generalized estimating equations for binary response model was used for estimation with factors for treatment, baseline CGI-S score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction.|GEE for binary response model|||Percentage of Participants With CGI-I Response at Day 8||3.47|0.91|0.0935
72547196|NCT02978326|144623734|SUPERIORITY||Odds Ratio (OR)|2.16||||0.0276|TWO_SIDED|95.0|1.09|4.28||Generalized estimating equations for binary response model was used for estimation with factors for treatment, baseline CGI-S score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction.|GEE for binary response model|||Percentage of Participants With CGI-I Response at Day 15||4.28|1.09|0.0276
72547197|NCT02978326|144623734|SUPERIORITY||Odds Ratio (OR)|1.79||||0.092|TWO_SIDED|95.0|0.91|3.54||Generalized estimating equations for binary response model was used for estimation with factors for treatment: Baseline CGI-S score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction.|GEE for binary response model|||Percentage of Participants With CGI-I Response at Day 21||3.54|0.91|0.0920
72547198|NCT02978326|144623734|SUPERIORITY||Odds Ratio (OR)|1.76||||0.1109|TWO_SIDED|95.0|0.88|3.51||Generalized estimating equations for binary response model was used for estimation with factors for treatment, baseline CGI-S score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction.|GEE for binary response model|||Percentage of Participants With CGI-I Response at Day 45||3.51|0.88|0.1109
72547199|NCT02978326|144623735|SUPERIORITY||LS Mean Difference|-3.1|STANDARD_ERROR_OF_MEAN|1.29||0.0169|TWO_SIDED|95.0|-5.7|-0.6||MMRM was used for estimation with treatment, baseline HAM-A total score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Change from Baseline in HAM-A Total Score at Day 3||-0.6|-5.7|0.0169
72547200|NCT02978326|144623735|SUPERIORITY||LS Mean Difference|-4.4|STANDARD_ERROR_OF_MEAN|1.32||0.001|TWO_SIDED|95.0|-7.0|-1.8||MMRM was used for estimation with treatment, baseline HAM-A total score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Change from Baseline in HAM-A Total Score at Day 8||-1.8|-7.0|0.0010
72412138|NCT01248884|144332317|NON_INFERIORITY|Non-inferiority in terms of immune response to diphteria antigens was demonstrated if the upper limit of the 97.5% confidence interval (CI) on the group difference (Infanrix hexa Group minus GSK2177744 Group 1) in the percentage of seroprotected subject was below or equal to 10%.|Difference in percentage|0.0|||||TWO_SIDED|97.5|-2.25|2.3||||||||2.3|-2.25|
72547201|NCT02978326|144623735|SUPERIORITY||LS Mean Difference|-3.9|STANDARD_ERROR_OF_MEAN|1.41||0.0063|TWO_SIDED|95.0|-6.7|-1.1||MMRM was used for estimation with treatment, baseline HAM-A total score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Change from Baseline in HAM-A Total Score at Day 15||-1.1|-6.7|0.0063
72547202|NCT02978326|144623735|SUPERIORITY||LS Mean Difference|-3.5|STANDARD_ERROR_OF_MEAN|1.37||0.0119|TWO_SIDED|95.0|-6.2|-0.8||MMRM was used for estimation with treatment, baseline HAM-A total score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Change from Baseline in HAM-A Total Score at Day 21||-0.8|-6.2|0.0119
72581092|NCT04886596|144691620|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|65.69|||||TWO_SIDED|95.0|28.56|85.47|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of complications related to RSV- ARI during the RSV seasons in adults ≥ 60 YOA, following a single dose of the RSVPreF3 OA investigational vaccine.||85.47|28.56|
72581093|NCT04886596|144691620|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|62.87|||||TWO_SIDED|95.0|21.45|84.29|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of complications related to RSV-ARI during the RSV seasons in adults ≥ 60 YOA, following annual revaccination of the RSVPreF3 OA investigational vaccine.||84.29|21.45|
72581094|NCT04886596|144691621|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|2.59|||||TWO_SIDED|95.0|-8.29|12.42|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of complications related to any ARI during the study period in adults ≥ 60 YOA, following a single dose of the RSVPreF3 OA investigational vaccine.||12.42|-8.29|
72581095|NCT04886596|144691621|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|6.7|||||TWO_SIDED|95.0|-4.05|16.39|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of complications related to any ARI during the study period in adults ≥ 60 YOA, following annual revaccination of the RSVPreF3 OA investigational vaccine.||16.39|-4.05|
72581096|NCT04886596|144691621|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|10.95|||||TWO_SIDED|95.0|-0.68|21.31|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of complications related to any ARI during the RSV seasons in adults ≥ 60 YOA, following a single dose of the RSVPreF3 OA investigational vaccine.||21.31|-0.68|
72547203|NCT02978326|144623735|SUPERIORITY||LS Mean Difference|-5.0|STANDARD_ERROR_OF_MEAN|1.28||0.0002|TWO_SIDED|95.0|-7.5|-2.4||MMRM was used for estimation with treatment, baseline HAM-A total score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Change from Baseline in HAM-A Total Score at Day 45||-2.4|-7.5|0.0002
72547204|NCT02978326|144623736|SUPERIORITY||Odds Ratio (OR)|1.75||||0.1145|TWO_SIDED|95.0|0.87|3.53||Generalized estimating equations for binary response model was used for estimation with factors for treatment, baseline MADRS total score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction.|GEE for binary response model|||Percentage of Participants With MADRS Response at Day 3||3.53|0.87|0.1145
72547205|NCT02978326|144623736|SUPERIORITY||Odds Ratio (OR)|1.71||||0.1069|TWO_SIDED|95.0|0.89|3.3||Generalized estimating equations for binary response model was used for estimation with factors for treatment, baseline MADRS total score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction.|GEE for binary response model|||Percentage of Participants With MADRS Response at Day 8||3.30|0.89|0.1069
72547206|NCT02978326|144623736|SUPERIORITY||Odds Ratio (OR)|2.67||||0.0045|TWO_SIDED|95.0|1.36|5.27||Generalized estimating equations for binary response model was used for estimation with factors for treatment, baseline MADRS total score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction.|GEE for binary response model|||Percentage of Participants With MADRS Response at Day 15||5.27|1.36|0.0045
72547207|NCT02978326|144623736|SUPERIORITY||Odds Ratio (OR)|2.01||||0.0421|TWO_SIDED|95.0|1.03|3.93||Generalized estimating equations for binary response model was used for estimation with factors for treatment, baseline MADRS total score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction.|GEE for binary response model|||Percentage of Participants With MADRS Response at Day 21||3.93|1.03|0.0421
72547208|NCT02978326|144623736|SUPERIORITY||Odds Ratio (OR)|1.99||||0.0541|TWO_SIDED|95.0|0.99|4.03||Generalized estimating equations for binary response model was used for estimation with factors for treatment, baseline MADRS total score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction.|GEE for binary response model|||Percentage of Participants With MADRS Response at Day 45||4.03|0.99|0.0541
72547209|NCT02978326|144623737|SUPERIORITY||Odds Ratio (OR)|2.84||||0.0326|TWO_SIDED|95.0|1.09|7.38||Generalized estimating equations for binary response model was used for estimation with factors for treatment, baseline MADRS total score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction.|GEE for binary response model|||Percentage of Participants With MADRS Remission at Day 3||7.38|1.09|0.0326
72547210|NCT02978326|144623737|SUPERIORITY||Odds Ratio (OR)|1.38||||0.3749|TWO_SIDED|95.0|0.68|2.79||Generalized estimating equations for binary response model was used for estimation with factors for treatment, baseline MADRS total score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction.|GEE for binary response model|||Percentage of Participants With MADRS Remission at Day 8||2.79|0.68|0.3749
72547211|NCT02978326|144623737|SUPERIORITY||Odds Ratio (OR)|2.49||||0.0087|TWO_SIDED|95.0|1.26|4.92||Generalized estimating equations for binary response model was used for estimation with factors for treatment, baseline MADRS total score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction.|GEE for binary response model|||Percentage of Participants With MADRS Remission at Day 15||4.92|1.26|0.0087
72547212|NCT02978326|144623737|SUPERIORITY||Odds Ratio (OR)|2.18||||0.0257|TWO_SIDED|95.0|1.1|4.31||Generalized estimating equations for binary response model was used for estimation with factors for treatment, baseline MADRS total score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction.|GEE for binary response model|||Percentage of Participants With MADRS Remission at Day 21||4.31|1.10|0.0257
72547213|NCT02978326|144623737|SUPERIORITY||Odds Ratio (OR)|2.08||||0.0339|TWO_SIDED|95.0|1.06|4.09||Generalized estimating equations for binary response model was used for estimation with factors for treatment, baseline MADRS total score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction.|GEE for binary response model|||Percentage of Participants With MADRS Remission at Day 45||4.09|1.06|0.0339
72547214|NCT00947427|144623744|SUPERIORITY_OR_OTHER_LEGACY|||||||0.86|||||||ANCOVA|||||||0.86
72547215|NCT01937364|144623751|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.4||||0.0334|TWO_SIDED|90.0|-0.7275|-0.0206||One-sided p-value|z-statistic with pooled estimate||RD = Baclofen - Placebo|||-0.0206|-0.7275|0.0334
72581097|NCT04886596|144691621|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|12.12|||||TWO_SIDED|95.0|0.32|22.58|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of complications related to any ARI during the RSV seasons in adults ≥ 60 YOA, following annual revaccination of the RSVPreF3 OA investigational vaccine.||22.58|0.32|
72581098|NCT02777372|144691676|OTHER|||||||0.139|||||||Regression, Linear|||Effect of group on differences in ASR t scores from follicular to luteal.||||0.139
72412139|NCT01248884|144332317|NON_INFERIORITY|Non-inferiority in terms of immune response to tetanus antigens was demonstrated if the upper limit of the 97.5% confidence interval (CI) on the group difference (Infanrix hexa Group minus GSK2177744 Group 1) in the percentage of seroprotected subject was below or equal to 10%.|Difference in percentage|0.0|||||TWO_SIDED|97.5|-2.25|2.3||||||||2.3|-2.25|
72547216|NCT01937364|144623752|SUPERIORITY_OR_OTHER|||||||0.3744|||||||Mixed Models Analysis|||Baclofen - Placebo; 24 hours||||0.3744
72547217|NCT01937364|144623752|SUPERIORITY_OR_OTHER|||||||0.7616|||||||Mixed Models Analysis|||Baclofen - Placebo; 48 hours||||0.7616
72581099|NCT02777372|144691677|OTHER|||||||0.843||||||Effect of group on ASR t score in the first luteal phase (no medication) to the second luteal phase (sertraline).|Regression, Linear|||||||0.843
72581100|NCT02777372|144691678|OTHER|||||||0.06|||||||t-test, 2 sided|||||||0.06
72412140|NCT01248884|144332317|NON_INFERIORITY|Non-inferiority in terms of immune response to diphteria antigens was demonstrated if the upper limit of the 97.5% confidence interval (CI) on the group difference (Infanrix hexa Group minus GSK2177744 Group 2) in the percentage of seroprotected subject was below or equal to 10%.|Difference in percentage|0.0|||||TWO_SIDED|97.5|-2.25|2.27||||||||2.27|-2.25|
72547218|NCT01937364|144623752|SUPERIORITY_OR_OTHER|||||||0.1393|||||||Mixed Models Analysis|||Baclofen - Placebo; 72 hours||||0.1393
72547219|NCT01937364|144623753|SUPERIORITY_OR_OTHER|||||||0.33||||||Baclofen - Placebo; Peak Ativan 1mg PO equivalent dose|Wilcoxon (Mann-Whitney)|||||||0.33
72547220|NCT01937364|144623753|SUPERIORITY_OR_OTHER|||||||0.8|||||||Wilcoxon (Mann-Whitney)|||Baclofen - Placebo; Total Ativan 1mg PO equivalent dose||||0.80
72547221|NCT00936975|144623754|SUPERIORITY_OR_OTHER||Slope|-6.6084|STANDARD_ERROR_OF_MEAN|1.7644|<|0.001|TWO_SIDED|||||GEEs were used to model the change in tumor uptake between baseline and 12 weeks. GEEs were used to adjust for the correlation of 37 tumors in 12 patients measured at 2 time points and to adjust for age as a confounder.|GEE||GEEs, rather than a simple mean difference, were used to account for the multiple (clustered) bone measurement values within a patient and to adjust for age so that appropriate SE estimates (and thus p-values) were produced.|This was an exploratory study and no a priori assumptions were employed.||||<0.001
72547222|NCT00936975|144623755|SUPERIORITY_OR_OTHER||Slope|-0.0115|STANDARD_ERROR_OF_MEAN|0.0089||0.1945|TWO_SIDED|||||GEEs were used to model the change in tumor uptake between baseline and 12 weeks. GEEs were used to adjust for the correlation of 37 tumors in 12 patients measured at 2 time points and to adjust for age as a confounder.|GEE|GEE was used to model the change, accounting for 37 tumors in 12 patients measured at 2 time points.|GEEs, rather than a simple mean difference, were used to account for the multiple (clustered) bone measurement values within a patient and to adjust for age so that appropriate SE estimates (and thus p-values) were produced.|the difference in Patlak flux in tumor bone between baseline and 12 weeks, accounting for the fact that each participant could contribute more than one tumor bone.||||0.1945
72547223|NCT00936975|144623756|SUPERIORITY_OR_OTHER||Slope|0.33|STANDARD_ERROR_OF_MEAN|0.3274||0.32|TWO_SIDED|||||GEEs were used to model the change in tumor uptake between baseline and 12 weeks. GEEs were used to adjust for the correlation of 37 tumors in 12 patients measured at 2 time points and to adjust for age as a confounder.|Generalized Estimating Equation|GEE was used to model the change, accounting for 37 tumors in 12 patients measured at 2 time points.|GEEs, rather than a simple mean difference, were used to account for the multiple (clustered) bone measurement values within a patient and to adjust for age so that appropriate SE estimates (and thus p-values) were produced.|||||0.32
72547224|NCT00936975|144623756|SUPERIORITY_OR_OTHER||Slope|6.98|STANDARD_ERROR_OF_MEAN|1.6943|<|0.001|TWO_SIDED|||||GEEs were used to model the change in tumor uptake between baseline and 12 weeks. GEEs were used to adjust for the correlation of 37 tumors in 12 patients measured at 2 time points and to adjust for age as a confounder.|Generalized Estimating Equations|Age was included in the model as a confounder|Estimated value is the slope of the Normal bone. Tumor Bone was used as reference category. GEEs, rather than a simple mean difference, were used to account for clustering and correlation of bone measurement values within a patient|H0: No difference in uptake b/w normal \& tumor bones||||<0.001
72547225|NCT00936975|144623757|SUPERIORITY_OR_OTHER||Slope|-0.0177|STANDARD_ERROR_OF_MEAN|0.0125||0.16|TWO_SIDED|||||GEEs were used to model the change in tumor uptake between baseline and 12 weeks. GEEs were used to adjust for the correlation of 37 tumors in 12 patients measured at 2 time points and to adjust for age as a confounder.|Generalized Estimating Equations|GEE was used to model the change, accounting for 37 tumors in 12 patients measured at 2 time points.|GEEs, rather than a simple mean difference, were used to account for the multiple (clustered) bone measurement values within a patient and to adjust for age so that appropriate SE estimates (and thus p-values) were produced.|||||0.16
72547226|NCT00936975|144623758|SUPERIORITY_OR_OTHER||Slope|0.0017|STANDARD_ERROR_OF_MEAN|0.0027||0.53|TWO_SIDED||||||Generalized Estimating Equation|GEE was used to model the change, accounting for 37 tumors in 12 patients measured at 2 time points.|GEEs, rather than a simple mean difference, were used to account for the multiple (clustered) bone measurement values within a patient and to adjust for age so that appropriate SE estimates (and thus p-values) were produced.|||||0.53
72547227|NCT00936975|144623758|SUPERIORITY_OR_OTHER||Slope|0.0205|STANDARD_ERROR_OF_MEAN|0.0128||0.1095|TWO_SIDED|||||GEEs were used to model the change in tumor uptake between baseline and 12 weeks. GEEs were used to adjust for the correlation of 37 tumors in 12 patients measured at 2 time points and to adjust for age as a confounder.|Generalized estimating equations|Age was included in the model as a confounder|Estimated value is the slope of the Normal bone. Tumor Bone was used as reference category. GEEs, rather than a simple mean difference, were used to account for clustering and correlation of bone measurement values within a patient|H0: influx(Ki) is the same in normal and tumor bones||||0.1095
72552694|NCT00322465|144636213|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.74||||0.005|TWO_SIDED|95.0|0.6|0.91||A priori threshold for statistical significance was p\<0.05.|Regression, Logistic|Odds ratio has been adjusted for other independent variables included in the model, which are found in the other Statistical Analysis sections.||The null hypothesis is that the odds ratio for age (per 5 years) is 1 versus the alternative that it is greater than or less than 1. This was tested in a multivariable logistic regression model.||0.91|0.60|0.005
72581101|NCT04661150|144691680|SUPERIORITY||Treatment difference|23.8||||0.079|TWO_SIDED|90.0|1.3|44.7|||Chi-squared|||||44.7|1.3|0.079
72581102|NCT04661150|144691685|SUPERIORITY||Treatment difference|-4.8||||0.739|TWO_SIDED|90.0|-27.9|18.9|||Chi-squared|||||18.9|-27.9|0.739
72552695|NCT00322465|144636213|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.87||||0.78|TWO_SIDED|95.0|0.33|2.3||A priori threshold for statistical significance was p\<0.05.|Regression, Logistic|Odds ratio has been adjusted for other independent variables included in the model, which are found in the other Statistical Analysis sections.||The null hypothesis is that the odds ratio for scant discharge (reference category is no discharge) is 1 versus the alternative that it is greater than or less than 1. This was tested in a multivariable logistic regression model.||2.30|0.33|0.780
72581103|NCT04661150|144691686|SUPERIORITY||Treatment difference|4.8|||>|0.999|TWO_SIDED|90.0|-10.9|21.4|||Fisher Exact|||||21.4|-10.9|>0.999
72547228|NCT00936975|144623759|SUPERIORITY_OR_OTHER||Slope|0.0061|STANDARD_ERROR_OF_MEAN|0.0021||0.0033|TWO_SIDED|||||GEEs were used to model the change in tumor uptake between baseline and 12 weeks. GEEs were used to adjust for the correlation of 37 tumors in 12 patients measured at 2 time points and to adjust for age as a confounder.|Generalized Estimating Equations|GEE was used to model the change, accounting for 37 bones in 12 patients measured at 2 time points.|GEEs, rather than a simple mean difference, were used to account for the multiple (clustered) bone measurement values within a patient and to adjust for age so that appropriate SE estimates (and thus p-values) were produced.|||||0.0033
72547229|NCT00936975|144623759|SUPERIORITY_OR_OTHER||Slope|0.0177|STANDARD_ERROR_OF_MEAN|0.0097||0.067|TWO_SIDED|||||GEEs were used to model the change in tumor uptake between baseline and 12 weeks. GEEs were used to adjust for the correlation of 37 tumors in 12 patients measured at 2 time points and to adjust for age as a confounder.|Generalized estimating equations|Age was included in the model as a confounder|GEEs, rather than a simple mean difference, were used to account for the multiple (clustered) bone measurement values within a patient and to adjust for age so that appropriate SE estimates (and thus p-values) were produced.|H0: Change Patlak Flux from TP1 to TP2 is the same in normal and tumor bones||||0.0670
72547230|NCT00936975|144623759|SUPERIORITY_OR_OTHER||Slope|32.3288|STANDARD_ERROR_OF_MEAN|14.6956||0.0278|TWO_SIDED|||||GEEs were used to model the change in tumor uptake between baseline and 12 weeks. GEEs were used to adjust for the correlation of 37 tumors in 12 patients measured at 2 time points and to adjust for age as a confounder.|Generalized estimating equations||Estimated value is the slope of the Normal bone. Tumor Bone was used as reference category. GEEs, rather than a simple mean difference, were used to account for clustering and correlation of bone measurement values within a patient|H0: %Change in Patlak Flux between timepoint 1 and 2 is the same for Normal and Tumor bones||||0.0278
72547231|NCT03977584|144623794|SUPERIORITY||Difference in Annualized Rate of Change|-0.013|STANDARD_ERROR_OF_MEAN|0.00993||0.1953|TWO_SIDED|95.0|-0.0327|0.0068|||RCRM|||Analysis was based on RCRM using unstructured covariance matrix: GTP1 PET = Treatment \* Analysis Year + Interactive Voice or Web Response System (IxRS) defined Age Group + IxRS defined Education History + IxRS defined apolipoprotein (APOE4) Carrier Status + IxRS defined Clinical Dementia Rating Global Score.||0.0068|-0.0327|0.1953
72547232|NCT03504852|144623797|SUPERIORITY||Risk Difference (RD)|17.72||||0.0003|TWO_SIDED|95.0|7.45|27.98||One-sided p-value|Regression, Logistic|||||27.98|7.45|0.0003
72547233|NCT03504852|144623797|SUPERIORITY||Odds Ratio (OR)|2.33||||0.0003|TWO_SIDED|95.0|1.44|3.78||One-sided p-value|Regression, Logistic|||||3.78|1.44|0.0003
72547234|NCT03504852|144623798|SUPERIORITY||Risk Difference (RD)|8.28||||0.0498|TWO_SIDED|95.0|-1.65|18.2||One-sided p-value|Regression, Logistic|||||18.20|-1.65|0.0498
72547235|NCT03504852|144623798|SUPERIORITY||Odds Ratio (OR)|1.51||||0.0498|TWO_SIDED|95.0|0.92|2.47||One-sided p-value|Regression, Logistic|||||2.47|0.92|0.0498
72547236|NCT02928848|144623806|OTHER|||||||0.14||||||The a priori threshold for statistical significance was p \< .05.|ANOVA|||Repeated-measures analysis of variance (RM-ANOVA) with Condition (active, sham) and time point (baseline, 0-week) as within-subject factors. Analysis tests whether active vs. sham stimulation confers a greater improvement in overall language ability, as measured by the Western Aphasia Battery Aphasia Quotient (WAB-AQ), that endures over time.||||0.14
72547237|NCT02928848|144623807|OTHER|||||||0.02||||||The a priori threshold for statistical significance was p \< .05.|ANOVA|||Repeated-measures analysis of variance (RM-ANOVA) with Condition (active, sham) and time point (baseline, 0-weeks) as within-subject factors. Analysis tests whether active vs. sham stimulation confers a greater improvement in naming ability, as measured by the naming subtest of the WAB, that endures over time.||||.02
72581104|NCT03135015|144691709|OTHER||Percentage Change from Control|-14.09||||0.1146|TWO_SIDED||||||t-test, 2 sided|||The blinded AUC results for the 6 treatments will be subjected to repeated measures analysis of variance (ANOVA) examining for the main effects of treatment and participant-group, and treatment\*group interaction. After demonstration of significant heterogeneity among the 6 coded treatments, differences between individual means will be assessed using Tukey's test to adjust for multiple comparisons.||||0.1146
72547238|NCT01835145|144623833|SUPERIORITY|||||||0.7|||||||Chi-squared|||A one-sided chi-squared test for a difference in PFS4 rates will be used to test for a difference between arms.||||0.70
72547239|NCT00582309|144623854|NON_INFERIORITY_OR_EQUIVALENCE|Original Power Analysis: The expected differences in mean blood glucose concentration between groups are \> 30 mg/dL. Assuming two-tailed alpha of .05, a standard deviation of approximately 40, and a one-to-one allocation and no subject attrition, fifty patients per treatment group (150 total) will be sufficient to achieve 90% power for group mean comparisons allowing for multiple comparisons.|||||<|0.05|TWO_SIDED|95.0||||All results obtained by ANOVA are verified by the nonparametric Kruskal-Wallis test. Statistical significance will be judged by P-values \< 0.05.|ANOVA|||Demographic and baseline measurements are reported as either means and standard deviations or as frequency and percentages. These and the outcome measures are compared among the three groups by 1-way analysis of variance (ANOVA) for means or by Fisher's Exact test for frequencies as appropriate. If there is an overall significant difference, the post hoc multiple comparisons will be done by Fisher's least significant difference method.||||<0.05
72547240|NCT00458302|144623915|NON_INFERIORITY_OR_EQUIVALENCE|The primary comparison was performed at Week 48. If at Week 48, the lower limit of the 95% two-sided confidence interval of the difference between DRV/r and DRV/r+2NRTIs exceeds -12%, non-inferiority of the DRV/r 800/100 once a day (O.D) monotherapy versus the DRV/r 800/100 mg O.D. plus two NRTIs triple combination therapy was concluded.|Difference in proportion of response|-1.6|||||TWO_SIDED|95.0|-10.1|6.8|||||Difference in proportion of response DRV/r minus DRV/r+2NRTIs.|Assuming a virologic response rate of 90% at 48 weeks for both treatment arms, 111 patients were required per treatment arm to establish non-inferiority of DRV/r versus triple regimen with a maximum allowable difference of 12%, with a one-sided significance level of p=0.025 and 80% power. To account for a maximum of 10% major protocol violations that would be excluded from the on-protocol analysis, 125 patients were recruited in each treatment arm, so 250 patients in total.||6.8|-10.1|
72581105|NCT03135015|144691709|OTHER||Percentage Change from Control|-17.42||||0.0519|TWO_SIDED||||||t-test, 2 sided|||The blinded AUC results for the 6 treatments will be subjected to repeated measures analysis of variance (ANOVA) examining for the main effects of treatment and participant-group, and treatment\*group interaction. After demonstration of significant heterogeneity among the 6 coded treatments, differences between individual means will be assessed using Tukey's test to adjust for multiple comparisons.||||0.0519
72547241|NCT00458302|144623916|NON_INFERIORITY_OR_EQUIVALENCE|If at Week 48, the lower limit of the 95% two-sided confidence interval of the difference between DRV/r and DRV/r+2NRTIs exceeds -12%, non-inferiority of the DRV/r 800/100 once a day (O.D) monotherapy versus the DRV/r 800/100 mg O.D. plus two NRTIs triple combination therapy was concluded.|Difference in proportion of response|-1.0|||||TWO_SIDED|95.0|-9.9|7.8|||||Difference in proportion of response DRV/r minus DRV/r+2NRTIs.|Assuming a virologic response rate of 90% at 48 weeks for both treatment arms, 111 patients were required per treatment arm to establish non-inferiority of DRV/r versus triple regimen with a maximum allowable difference of 12%, with a one-sided significance level of p=0.025 and 80% power. To account for a maximum of 10% major protocol violations that would be excluded from the on-protocol analysis, 125 patients were recruited in each treatment are, so 250 patients in total.||7.8|-9.9|
72547242|NCT00458302|144623918|SUPERIORITY_OR_OTHER||Difference in proportion of response|1.29|||||TWO_SIDED|95.0|-7.99|10.58|||||Difference in proportion of response DRV/r minus DRV/r+2NRTIs.|||10.58|-7.99|
72547243|NCT02146430|144623948|SUPERIORITY||Mean Difference (Final Values)|-0.25|STANDARD_ERROR_OF_MEAN|0.187||0.187|TWO_SIDED|95.0|-0.61|0.12|||Difference of means|||||0.12|-0.61|0.1870
72547244|NCT02146430|144623948|SUPERIORITY||Mean Difference (Final Values)|-0.31|STANDARD_ERROR_OF_MEAN|0.185||0.0944|TWO_SIDED|95.0|-0.67|0.05|||Difference of means|||||0.05|-0.67|0.0944
72547245|NCT02146430|144623948|SUPERIORITY||Mean Difference (Final Values)|-0.28|STANDARD_ERROR_OF_MEAN|0.187||0.1391|TWO_SIDED|95.0|-0.64|0.09|||Difference of means|||||0.09|-0.64|0.1391
72547246|NCT02146430|144623948|SUPERIORITY||Mean Difference (Final Values)|-0.06|STANDARD_ERROR_OF_MEAN|0.187||0.7338|TWO_SIDED|95.0|-0.43|0.3|||Difference of means|||||0.30|-0.43|0.7338
72547247|NCT02146430|144623948|SUPERIORITY||Mean Difference (Final Values)|-0.03|STANDARD_ERROR_OF_MEAN|0.19||0.8705|TWO_SIDED|95.0|-0.4|0.34|||Difference of means|||||0.34|-0.40|0.8705
72547248|NCT02146430|144623950|SUPERIORITY||Mean Difference (Final Values)|-3.4|STANDARD_ERROR_OF_MEAN|1.592||0.0326|TWO_SIDED|95.0|-6.52|-0.28|||Difference of means|||||-0.28|-6.52|0.0326
72547249|NCT02146430|144623950|SUPERIORITY||Mean Difference (Final Values)|-1.28|STANDARD_ERROR_OF_MEAN|1.592||0.422|TWO_SIDED|95.0|-4.4|1.84|||Difference of means|||||1.84|-4.40|0.4220
72547250|NCT02146430|144623950|SUPERIORITY||Mean Difference (Final Values)|0.07|STANDARD_ERROR_OF_MEAN|1.615||0.9659|TWO_SIDED|95.0|-3.1|3.23|||Difference of means|||||3.23|-3.10|0.9659
72547251|NCT02146430|144623950|SUPERIORITY||Mean Difference (Final Values)|2.12|STANDARD_ERROR_OF_MEAN|1.608||0.1867|TWO_SIDED|95.0|-1.03|5.28|||Difference of means|||||5.28|-1.03|0.1867
72547252|NCT02146430|144623950|SUPERIORITY||Mean Difference (Final Values)|3.47|STANDARD_ERROR_OF_MEAN|1.631||0.0333|TWO_SIDED|95.0|0.27|6.67|||Difference of means|||||6.67|0.27|0.0333
72581106|NCT03135015|144691709|OTHER||Percentage Change from Control|-8.95|||||TWO_SIDED|||||||||The blinded AUC results for the 6 treatments will be subjected to repeated measures analysis of variance (ANOVA) examining for the main effects of treatment and participant-group, and treatment\*group interaction. After demonstration of significant heterogeneity among the 6 coded treatments, differences between individual means will be assessed using Tukey's test to adjust for multiple comparisons.||||
72547253|NCT02146430|144623952|SUPERIORITY||Difference in least squares means|-0.3|STANDARD_ERROR_OF_MEAN|0.28||0.2474|TWO_SIDED|95.0|-0.9|0.2|||ANCOVA|||||0.2|-0.9|0.2474
72547254|NCT02146430|144623952|SUPERIORITY||Difference in least squares means|-0.3|STANDARD_ERROR_OF_MEAN|0.28||0.3347|TWO_SIDED|95.0|-0.8|0.3|||ANCOVA|||||0.3|-0.8|0.3347
72547255|NCT02146430|144623952|SUPERIORITY||Difference in least squares means|0.2|STANDARD_ERROR_OF_MEAN|0.28||0.3999|TWO_SIDED|95.0|-0.3|0.8|||ANCOVA|||||0.8|-0.3|0.3999
72547256|NCT02146430|144623952|SUPERIORITY||Difference in least squares means|0.1|STANDARD_ERROR_OF_MEAN|0.28||0.8435|TWO_SIDED|95.0|-0.5|0.6|||ANCOVA|||||0.6|-0.5|0.8435
72547257|NCT02146430|144623952|SUPERIORITY||Difference in least squares means|0.6|STANDARD_ERROR_OF_MEAN|0.28||0.0446|TWO_SIDED|95.0|0.0|1.1|||ANCOVA|||||1.1|0.0|0.0446
72547258|NCT02146430|144623953|SUPERIORITY||Difference of least squares means|0.0|STANDARD_ERROR_OF_MEAN|0.24||0.9775|TWO_SIDED|95.0|-0.5|0.5|||ANCOVA|||Anxiety: Placebo vs Pregabalin 150 mg BID||0.5|-0.5|0.9775
72547259|NCT02146430|144623953|SUPERIORITY||Difference in least squares means|-0.1|STANDARD_ERROR_OF_MEAN|0.24||0.65|TWO_SIDED|95.0|-0.6|0.4|||ANCOVA|||Anxiety: Placebo vs DS-5565 15 mg QD||0.4|-0.6|0.6500
72547260|NCT02146430|144623953|SUPERIORITY||Difference in least squares means|-0.1|STANDARD_ERROR_OF_MEAN|0.24||0.6546|TWO_SIDED|95.0|-0.6|0.4|||ANCOVA|||Anxiety: Placebo vs DS-5565 15 mg BID||0.4|-0.6|0.6546
72581107|NCT03135015|144691710|OTHER|||||||0.1146|||||||t-test, 2 sided|||The blinded AUC results for the 6 treatments will be subjected to repeated measures analysis of variance (ANOVA) examining for the main effects of treatment and participant-group, and treatment\*group interaction. After demonstration of significant heterogeneity among the 6 coded treatments, differences between individual means will be assessed using Tukey's test to adjust for multiple comparisons||||0.1146
72581108|NCT03135015|144691710|OTHER|||||||0.0519|||||||t-test, 2 sided|||The blinded AUC results for the 6 treatments will be subjected to repeated measures analysis of variance (ANOVA) examining for the main effects of treatment and participant-group, and treatment\*group interaction. After demonstration of significant heterogeneity among the 6 coded treatments, differences between individual means will be assessed using Tukey's test to adjust for multiple comparisons||||0.0519
72581109|NCT03135015|144691711|OTHER|||||||0.5827|||||||t-test, 2 sided|||The blinded AUC results for the 6 treatments will be subjected to repeated measures analysis of variance (ANOVA) examining for the main effects of treatment and participant-group, and treatment\*group interaction. After demonstration of significant heterogeneity among the 6 coded treatments, differences between individual means will be assessed using Tukey's test to adjust for multiple comparisons.||||0.5827
72581110|NCT03135015|144691711|OTHER|||||||0.5485|||||||t-test, 2 sided|||The blinded AUC results for the 6 treatments will be subjected to repeated measures analysis of variance (ANOVA) examining for the main effects of treatment and participant-group, and treatment\*group interaction. After demonstration of significant heterogeneity among the 6 coded treatments, differences between individual means will be assessed using Tukey's test to adjust for multiple comparisons.||||0.5485
72412141|NCT01248884|144332317|NON_INFERIORITY|Non-inferiority in terms of immune response to tetanus antigens was demonstrated if the upper limit of the 97.5% confidence interval (CI) on the group difference (Infanrix hexa Group minus GSK2177744 Group 2) in the percentage of seroprotected subject was below or equal to 10%.|Difference in percentage|0.0|||||TWO_SIDED|97.5|-2.25|2.27||||||||2.27|-2.25|
72412142|NCT01248884|144332319|NON_INFERIORITY|Non-inferiority in terms of immune response to pertussis antigen (anti-PT) was demonstrated if the upper limit of the 97.5% confidence interval (CI) on the GMC ratio (Infanrix hexa Group divided by GSK2177744 Group 1) was below or equal to 1.5.|GMC ratio|1.26|||||TWO_SIDED|97.5|1.11|1.44||||||||1.44|1.11|
72547261|NCT02146430|144623953|SUPERIORITY||Difference in least squares means|-0.1|STANDARD_ERROR_OF_MEAN|0.24||0.6692|TWO_SIDED|95.0|-0.6|0.4|||ANCOVA|||Anxiety: Pregabalin 150 mg BID vs DS-5565 15 mg QD||0.4|-0.6|0.6692
72547262|NCT02146430|144623953|SUPERIORITY||Difference in least squares means|-0.1|STANDARD_ERROR_OF_MEAN|0.24||0.6737|TWO_SIDED|95.0|-0.6|0.4|||ANCOVA|||Anxiety: Pregabalin 150 mg BID vs DS-5565 15 mg BID||0.4|-0.6|0.6737
72547263|NCT02146430|144623953|SUPERIORITY||Difference in least squares means|-0.2|STANDARD_ERROR_OF_MEAN|0.27||0.3888|TWO_SIDED|95.0|-0.8|0.3|||ANCOVA|||Depression: Placebo vs Pregabalin 150 mg BID||0.3|-0.8|0.3888
72547264|NCT02146430|144623953|SUPERIORITY||Difference in least squares means|0.0|STANDARD_ERROR_OF_MEAN|0.27||0.92|TWO_SIDED|95.0|-0.5|0.6|||ANCOVA|||Depression: Placebo vs DS-5565 15 mg QD||0.6|-0.5|0.9200
72547265|NCT02146430|144623953|SUPERIORITY||Difference in least squares means|0.1|STANDARD_ERROR_OF_MEAN|0.27||0.7061|TWO_SIDED|95.0|-0.4|0.6|||ANCOVA|||Depression: Placebo vs DS-5565 15 mg BID||0.6|-0.4|0.7061
72547266|NCT02146430|144623953|SUPERIORITY||Difference in least squares means|0.3|STANDARD_ERROR_OF_MEAN|0.27||0.3337|TWO_SIDED|95.0|-0.3|0.8|||ANCOVA|||Depression: Pregabalin 150 mg BID vs DS-5565 15 mg QD||0.8|-0.3|0.3337
72547267|NCT02146430|144623953|SUPERIORITY||Difference in least squares means|0.3|STANDARD_ERROR_OF_MEAN|0.27||0.2139|TWO_SIDED|95.0|-0.2|0.9|||ANCOVA|||Depression: Pregabalin 150 mg BID vs DS-5565 15 mg BID||0.9|-0.2|0.2139
72547268|NCT02146430|144623954|SUPERIORITY||Difference in least squares means|2.197|STANDARD_ERROR_OF_MEAN|1.4933||0.1416|TWO_SIDED|95.0|-0.733|5.126|||ANCOVA|||Physical Component: Placebo vs Pregabalin 150 mg BID||5.126|-0.733|0.1416
72547269|NCT02146430|144623954|SUPERIORITY||Difference in least squares means|0.249|STANDARD_ERROR_OF_MEAN|1.492||0.8677|TWO_SIDED|95.0|-2.679|3.176|||ANCOVA|||Physical Component: Placebo vs DS-5565 15 mg QD||3.176|-2.679|0.8677
72547270|NCT02146430|144623954|SUPERIORITY||Difference in least squares means|-0.899|STANDARD_ERROR_OF_MEAN|1.4959||0.5481|TWO_SIDED|95.0|-3.834|2.036|||ANCOVA|||Physical Component: Placebo vs DS-5565 15 mg BID||2.036|-3.834|0.5481
72547271|NCT02146430|144623954|SUPERIORITY||Difference in least squares means|-1.948|STANDARD_ERROR_OF_MEAN|1.4875||0.1906|TWO_SIDED|95.0|-4.866|0.971|||ANCOVA|||Physical Component: Pregabalin 150 mg BID vs DS-5565 15 mg QD||0.971|-4.866|0.1906
72547272|NCT02146430|144623954|SUPERIORITY||Difference in least squares means|-3.095|STANDARD_ERROR_OF_MEAN|1.4883||0.0378|TWO_SIDED|95.0|-6.015|-0.175|||ANCOVA|||Physical Component: Pregabalin 150 mg BID vs DS-5565 15 mg BID||-0.175|-6.015|0.0378
72547273|NCT02146430|144623954|SUPERIORITY||Difference in least squares means|0.664|STANDARD_ERROR_OF_MEAN|0.6865||0.3337|TWO_SIDED|95.0|-0.683|2.011|||ANCOVA|||Mental Component: Placebo vs Pregabalin 150 mg BID||2.011|-0.683|0.3337
72547274|NCT02146430|144623954|SUPERIORITY||Difference in least squares means|-0.194|STANDARD_ERROR_OF_MEAN|0.686||0.7778|TWO_SIDED|95.0|-1.54|1.152|||ANCOVA|||Mental Component: Placebo vs DS-5565 15 mg QD||1.152|-1.540|0.7778
72547275|NCT02146430|144623954|SUPERIORITY||Difference in least squares means|-0.087|STANDARD_ERROR_OF_MEAN|0.6879||0.8991|TWO_SIDED|95.0|-1.437|1.262|||ANCOVA|||Mental Component: Placebo vs DS-5565 15 mg BID||1.262|-1.437|0.8991
72547276|NCT02146430|144623954|SUPERIORITY||Difference in least squares means|-0.857|STANDARD_ERROR_OF_MEAN|0.6833||0.2098|TWO_SIDED|95.0|-2.198|0.483|||ANCOVA|||Mental Component: Pregabalin 150 mg BID vs DS-5565 15 mg QD||0.483|-2.198|0.2098
72547277|NCT02146430|144623954|SUPERIORITY||Difference in least squares means|-0.751|STANDARD_ERROR_OF_MEAN|0.6842||0.2725|TWO_SIDED|95.0|-2.093|0.591|||ANCOVA|||Mental Component: Pregabalin 150 mg BID vs DS-5565 15 mg BID||0.591|-2.093|0.2725
72547278|NCT02146430|144623955|SUPERIORITY||Difference in least squares means|0.0018|STANDARD_ERROR_OF_MEAN|0.01329||0.8923|TWO_SIDED|95.0|-0.0243|0.0279|||ANCOVA|||||0.0279|-0.0243|0.8923
72547279|NCT02146430|144623955|SUPERIORITY||Difference in least squares means|-0.0021|STANDARD_ERROR_OF_MEAN|0.01327||0.8749|TWO_SIDED|95.0|-0.0281|0.024|||ANCOVA|||||0.0240|-0.0281|0.8749
72547280|NCT02146430|144623955|SUPERIORITY||Difference in least squares means|-0.0091|STANDARD_ERROR_OF_MEAN|0.01332||0.4932|TWO_SIDED|95.0|-0.0353|0.017|||ANCOVA|||||0.0170|-0.0353|0.4932
72547281|NCT02146430|144623955|SUPERIORITY||Difference in least squares means|-0.0039|STANDARD_ERROR_OF_MEAN|0.01323||0.7688|TWO_SIDED|95.0|-0.0298|0.0221|||ANCOVA|||||0.0221|-0.0298|0.7688
72412143|NCT01248884|144332319|NON_INFERIORITY|Non-inferiority in terms of immune response to pertussis antigen (anti-PRN) was demonstrated if the upper limit of the 97.5% confidence interval (CI) on the GMC ratio (Infanrix hexa Group divided by GSK2177744 Group 1) was below or equal to 1.5.|GMC ratio|1.33|||||TWO_SIDED|97.5|1.14|1.54||||||||1.54|1.14|
72547282|NCT02146430|144623955|SUPERIORITY||Difference in least squares means|-0.0109|STANDARD_ERROR_OF_MEAN|0.01326||0.4099|TWO_SIDED|95.0|-0.0369|0.0151|||ANCOVA|||||0.0151|-0.0369|0.4099
72547283|NCT02146430|144623956|SUPERIORITY||Difference in least squares means|-0.55|STANDARD_ERROR_OF_MEAN|0.166||0.0009|TWO_SIDED|95.0|-0.88|-0.23|||Mixed Models Analysis|||||-0.23|-0.88|0.0009
72547284|NCT02146430|144623956|SUPERIORITY||Difference in least squares means|-0.63|STANDARD_ERROR_OF_MEAN|0.166||0.0001|TWO_SIDED|95.0|-0.96|-0.31|||Mixed Models Analysis|||||-0.31|-0.96|0.0001
72547285|NCT02146430|144623956|SUPERIORITY||Difference in least squares means|-0.85|STANDARD_ERROR_OF_MEAN|0.167|<|0.0001|TWO_SIDED|95.0|-1.17|-0.52|||Mixed Models Analysis|||||-0.52|-1.17|<0.0001
72547286|NCT02146430|144623956|SUPERIORITY||Difference in least squares means|-0.08|STANDARD_ERROR_OF_MEAN|0.167||0.6408|TWO_SIDED|95.0|-0.4|0.25|||Mixed Models Analysis|||||0.25|-0.40|0.6408
72547287|NCT02146430|144623956|SUPERIORITY||Difference in least squares means|-0.29|STANDARD_ERROR_OF_MEAN|0.167||0.0786|TWO_SIDED|95.0|-0.62|0.03|||Mixed Models Analysis|||||0.03|-0.62|0.0786
72547288|NCT02146430|144623958|SUPERIORITY||Difference of least squares means|-0.4|STANDARD_ERROR_OF_MEAN|0.19||0.0541|TWO_SIDED|95.0|-0.7|0.0|||ANCOVA|||Worst pain: Placebo vs Pregabalin 150 mg BID||0.0|-0.7|0.0541
72547289|NCT02146430|144623958|SUPERIORITY||Difference in least squares means|-0.1|STANDARD_ERROR_OF_MEAN|0.19||0.7771|TWO_SIDED|95.0|-0.4|0.3|||ANCOVA|||Worst pain: Placebo vs DS-5565 15 mg QD||0.3|-0.4|0.7771
72547290|NCT02146430|144623958|SUPERIORITY||Difference in least squares means|-0.1|STANDARD_ERROR_OF_MEAN|0.19||0.5488|TWO_SIDED|95.0|-0.5|0.3|||ANCOVA|||Worst pain: Placebo vs DS-5565 15 mg BID||0.3|-0.5|0.5488
72547291|NCT02146430|144623958|SUPERIORITY||Difference in least squares means|0.3|STANDARD_ERROR_OF_MEAN|0.19||0.0987|TWO_SIDED|95.0|-0.1|0.7|||ANCOVA|||Worst pain: Pregabalin 150 mg BID vs DS-5565 15 mg QD||0.7|-0.1|0.0987
72547292|NCT02146430|144623958|SUPERIORITY||Difference in least squares means|0.2|STANDARD_ERROR_OF_MEAN|0.19||0.184|TWO_SIDED|95.0|-0.1|0.6|||ANCOVA|||Worst pain: Pregabalin 150 mg BID vs DS-5565 15 mg BID||0.6|-0.1|0.1840
72547293|NCT02146430|144623958|SUPERIORITY||Difference in least squares means|-0.2|STANDARD_ERROR_OF_MEAN|0.18||0.1903|TWO_SIDED|95.0|-0.6|0.1|||ANCOVA|||Least pain: Placebo vs Pregabalin 150 mg BID||0.1|-0.6|0.1903
72547294|NCT02146430|144623958|SUPERIORITY||Difference in least squares means|-0.1|STANDARD_ERROR_OF_MEAN|0.18||0.5787|TWO_SIDED|95.0|-0.4|0.2|||ANCOVA|||Least pain: Placebo vs DS-5565 15 mg QD||0.2|-0.4|0.5787
72547295|NCT02146430|144623958|SUPERIORITY||Difference in least squares means|-0.1|STANDARD_ERROR_OF_MEAN|0.18||0.5535|TWO_SIDED|95.0|-0.5|0.2|||ANCOVA|||Least pain: Placebo vs DS-5565 15 mg BID||0.2|-0.5|0.5535
72547296|NCT02146430|144623958|SUPERIORITY||Difference in least squares means|0.1|STANDARD_ERROR_OF_MEAN|0.18||0.4476|TWO_SIDED|95.0|-0.2|0.5|||ANCOVA|||Least pain: Pregabalin 150 mg BID vs DS-5565 15 mg QD||0.5|-0.2|0.4476
72547297|NCT02146430|144623958|SUPERIORITY||Difference in least squares means|0.1|STANDARD_ERROR_OF_MEAN|0.18||0.4737|TWO_SIDED|95.0|-0.2|0.5|||ANCOVA|||Least pain: Pregabalin 150 mg BID vs DS-5565 15 mg BID||0.5|-0.2|0.4737
72547298|NCT02146430|144623958|SUPERIORITY||Difference in least squares means|-0.3|STANDARD_ERROR_OF_MEAN|0.16||0.0814|TWO_SIDED|95.0|-0.6|0.0|||ANCOVA|||Average pain: Placebo vs Pregabalin 150 mg BID||0.0|-0.6|0.0814
72547299|NCT02146430|144623958|SUPERIORITY||Difference in least squares means|-0.2|STANDARD_ERROR_OF_MEAN|0.16||0.3069|TWO_SIDED|95.0|-0.5|0.2|||ANCOVA|||Average pain: Placebo vs DS-5565 15 mg QD||0.2|-0.5|0.3069
72547300|NCT02146430|144623958|SUPERIORITY||Difference in least squares means|-0.1|STANDARD_ERROR_OF_MEAN|0.16||0.3916|TWO_SIDED|95.0|-0.5|0.2|||ANCOVA|||Average pain: Placebo vs DS-5565 15 mg BID||0.2|-0.5|0.3916
72412144|NCT01248884|144332319|NON_INFERIORITY|Non-inferiority in terms of immune response to pertussis antigen (anti-PT) was demonstrated if the upper limit of the 97.5% confidence interval (CI) on the GMC ratio (Infanrix hexa Group divided by GSK2177744 Group 2) was below or equal to 1.5.|GMC ratio|1.25|||||TWO_SIDED|97.5|1.1|1.43||||||||1.43|1.1|
72547301|NCT02146430|144623958|SUPERIORITY||Difference in least squares means|0.1|STANDARD_ERROR_OF_MEAN|0.16||0.4667|TWO_SIDED|95.0|-0.2|0.4|||ANCOVA|||Average pain: Pregabalin 150 mg BID vs DS-5565 15 mg QD||0.4|-0.2|0.4667
72412145|NCT01248884|144332319|NON_INFERIORITY|Non-inferiority in terms of immune response to pertussis antigen (anti-PRN) was demonstrated if the upper limit of the 97.5% confidence interval (CI) on the GMC ratio (Infanrix hexa Group divided by GSK2177744 Group 2) was below or equal to 1.5.|GMC ratio|1.58|||||TWO_SIDED|97.5|1.37|1.84||||||||1.84|1.37|
72412146|NCT01248884|144332320|NON_INFERIORITY|Non-inferiority in terms of immune response to PRP antigens was demonstrated if the upper limit of the 97.5 confidence interval (CI) on the group difference (Infanrix hexa Group minus GSK217744 Group 1) in the percentage of seroprotected subjects was below or equal to 10%.|Difference in percentage|-3.52|||||TWO_SIDED|97.5|-10.19|3.0||||||||3|-10.19|
72412147|NCT01248884|144332320|NON_INFERIORITY|Non-inferiority in terms of immune response to PRP antigens was demonstrated if the upper limit of the 97.5 confidence interval (CI) on the group difference (Infanrix hexa Group minus GSK217744 Group 2) in the percentage of seroprotected subjects was below or equal to 10%.|Difference in percentage|0.57|||||TWO_SIDED|97.5|-6.53|7.7||||||||7.7|-6.53|
72412148|NCT01248884|144332321|NON_INFERIORITY|Non-inferiority in terms of immune response to hepatitis B (HBs) antigens was demonstrated if the upper limit of the 97.5 confidence interval (CI) on the group difference (Infanrix hexa minus GSK217744 Group 1) in the percentage of seroprotected subjects was below or equal to 10%.|Difference in percentage|0.56|||||TWO_SIDED|97.5|-3.27|4.63||||||Immune response non-inferiority - anti-HBs (ELISA)||4.63|-3.27|
72412149|NCT01248884|144332321|NON_INFERIORITY|Non-inferiority in terms of immune response to hepatitis B (HBs) antigens was demonstrated if the upper limit of the 97.5 confidence interval (CI) on the group difference (Infanrix hexa minus GSK217744 Group 2) in the percentage of seroprotected subjects was below or equal to 10%.|Difference in percentage|-0.94|||||TWO_SIDED|97.5|-4.57|2.36||||||Immune response non-inferiority - anti-HBs (ELISA)||2.36|-4.57|
72412150|NCT01248884|144332321|NON_INFERIORITY|Non-inferiority in terms of immune response to hepatitis B (HBs) antigens was demonstrated if the upper limit of the 97.5 confidence interval (CI) on the group difference (Infanrix hexa minus GSK217744 Group 1) in the percentage of seroprotected subjects was below or equal to 10%.|Difference in percentage|-0.4|||||TWO_SIDED|97.5|-4.62|3.8||||||Immune response non-inferiority - anti-HBs (CLIA)||3.8|-4.62|
72547302|NCT02146430|144623958|SUPERIORITY||Difference in least squares means|0.1|STANDARD_ERROR_OF_MEAN|0.16||0.3744|TWO_SIDED|95.0|-0.2|0.5|||ANCOVA|||Average pain: Pregabalin 150 mg BID vs DS-5565 15 mg BID||0.5|-0.2|0.3744
72547303|NCT02146430|144623958|SUPERIORITY||Difference in least squares means|-0.2|STANDARD_ERROR_OF_MEAN|0.19||0.2959|TWO_SIDED|95.0|-0.6|0.2|||ANCOVA|||Pain right now: Placebo vs Pregabalin 150 mg BID||0.2|-0.6|0.2959
72547304|NCT02146430|144623958|SUPERIORITY||Difference in least squares means|0.0|STANDARD_ERROR_OF_MEAN|0.19||0.9119|TWO_SIDED|95.0|-0.4|0.4|||ANCOVA|||Pain right now: Placebo vs DS-5565 15 mg QD||0.4|-0.4|0.9119
72547305|NCT02146430|144623958|SUPERIORITY||Difference in least squares means|0.0|STANDARD_ERROR_OF_MEAN|0.19||0.9399|TWO_SIDED|95.0|-0.4|0.4|||ANCOVA|||Pain right now: Placebo vs DS-5565 15 mg BID||0.4|-0.4|0.9399
72547306|NCT02146430|144623958|SUPERIORITY||Difference in least squares means|0.2|STANDARD_ERROR_OF_MEAN|0.19||0.2455|TWO_SIDED|95.0|-0.2|0.6|||ANCOVA|||Pain right now: Pregabalin 150 mg BID vs DS-5565 15 mg BID||0.6|-0.2|0.2455
72547307|NCT02146430|144623958|SUPERIORITY||Difference in least squares means|0.2|STANDARD_ERROR_OF_MEAN|0.19||0.3311|TWO_SIDED|95.0|-0.2|0.6|||ANCOVA|||Pain right now: Pregabalin 150 mg BID vs DS-5565 15 mg BID||0.6|-0.2|0.3311
72547308|NCT02146430|144623958|SUPERIORITY||Difference in least squares means|-0.254|STANDARD_ERROR_OF_MEAN|0.1647||0.1233|TWO_SIDED|95.0|-0.577|0.069|||ANCOVA|||Severity score: Placebo vs Pregabalin 150 mg BID||0.069|-0.577|0.1233
72547309|NCT02146430|144623958|SUPERIORITY||Difference in least squares means|-0.072|STANDARD_ERROR_OF_MEAN|0.1643||0.661|TWO_SIDED|95.0|-0.394|0.25|||ANCOVA|||Severity score: Placebo vs DS-5565 15 mg QD||0.250|-0.394|0.6610
72547310|NCT02146430|144623958|SUPERIORITY||Difference in least squares means|-0.098|STANDARD_ERROR_OF_MEAN|0.1649||0.5514|TWO_SIDED|95.0|-0.422|0.225|||ANCOVA|||Severity score: Placebo vs DS-5565 15 mg BID||0.225|-0.422|0.5514
72547311|NCT02146430|144623958|SUPERIORITY||Difference in least squares means|0.182|STANDARD_ERROR_OF_MEAN|0.1638||0.2673|TWO_SIDED|95.0|-0.14|0.503|||ANCOVA|||Severity score: Pregabalin 150 mg BID vs DS-5565 15 mg QD||0.503|-0.140|0.2673
72547312|NCT02146430|144623958|SUPERIORITY||Difference in least squares means|0.156|STANDARD_ERROR_OF_MEAN|0.1644||0.3439|TWO_SIDED|95.0|-0.167|0.478|||ANCOVA|||Severity score: Pregabalin 150 mg BID vs DS-5565 15 mg BID||0.478|-0.167|0.3439
72547313|NCT02146430|144623958|SUPERIORITY||Difference in least squares means|2.6|STANDARD_ERROR_OF_MEAN|2.4||0.2708|TWO_SIDED|95.0|-2.1|7.4|||ANCOVA|||Relief (%) by treatment of pain: Placebo vs Pregabalin 150 mg BID||7.4|-2.1|0.2708
72547314|NCT02146430|144623958|SUPERIORITY||Difference in least squares means|1.2|STANDARD_ERROR_OF_MEAN|2.4||0.6285|TWO_SIDED|95.0|-3.5|5.9|||ANCOVA|||Relief (%) by treatment of pain: Placebo vs DS-5565 15 mg QD||5.9|-3.5|0.6285
72547315|NCT02146430|144623958|SUPERIORITY||Difference in least squares means|-0.2|STANDARD_ERROR_OF_MEAN|2.41||0.9177|TWO_SIDED|95.0|-5.0|4.5|||ANCOVA|||Relief (%) by treatment of pain: Placebo vs DS-5565 150 mg BID||4.5|-5.0|0.9177
72547316|NCT02146430|144623958|SUPERIORITY||Difference in least squares means|-1.5|STANDARD_ERROR_OF_MEAN|2.38||0.5334|TWO_SIDED|95.0|-6.2|3.2|||ANCOVA|||Relief (%) by treatment of pain: Pregabalin 150 mg BID vs DS-5565 15 mg QD||3.2|-6.2|0.5334
72547317|NCT02146430|144623958|SUPERIORITY||Difference in least squares means|-2.9|STANDARD_ERROR_OF_MEAN|2.39||0.2261|TWO_SIDED|95.0|-7.6|1.8|||ANCOVA|||Relief (%) by treatment of pain: Pregabalin 150 mg BID vs DS-5565 15 mg BID||1.8|-7.6|0.2261
72547318|NCT02146430|144623958|SUPERIORITY||Difference in least squares means|-3.87|STANDARD_ERROR_OF_MEAN|1.758||0.0281|TWO_SIDED|95.0|-7.32|-0.42|||ANCOVA|||Interference: Placebo vs Pregabalin 150 mg BID||-0.42|-7.32|0.0281
72547319|NCT02146430|144623958|SUPERIORITY||Difference in least squares means|-1.42|STANDARD_ERROR_OF_MEAN|1.756||0.419|TWO_SIDED|95.0|-4.87|2.03|||ANCOVA|||Interference: Placebo vs DS-5565 15 mg QD||2.03|-4.87|0.4190
72547320|NCT02146430|144623958|SUPERIORITY||Difference in least squares means|-1.61|STANDARD_ERROR_OF_MEAN|1.763||0.3622|TWO_SIDED|95.0|-5.06|1.85|||ANCOVA|||Interference: Placebo vs DS-5565 15 mg BID||1.85|-5.06|0.3622
72547321|NCT02146430|144623958|SUPERIORITY||Difference in least squares means|2.45|STANDARD_ERROR_OF_MEAN|1.75||0.1623|TWO_SIDED|95.0|-0.99|5.88|||ANCOVA|||Interference: Pregabalin 150 mg BID vs DS-5565 15 mg QD||5.88|-0.99|0.1623
72547322|NCT02146430|144623958|SUPERIORITY||Difference in least squares means|2.26|STANDARD_ERROR_OF_MEAN|1.753||0.1978|TWO_SIDED|95.0|-1.18|5.7|||ANCOVA|||Interference: Pregabalin 150 mg BID vs DS-5565 15 mg BID||5.70|-1.18|0.1978
72547323|NCT02146430|144623958|SUPERIORITY||Difference in least squares means|-0.4|STANDARD_ERROR_OF_MEAN|0.21||0.0867|TWO_SIDED|95.0|-0.8|0.1|||ANCOVA|||General activity: Placebo vs Pregabalin 150 mg BID||0.1|-0.8|0.0867
72547324|NCT02146430|144623958|SUPERIORITY||Difference in least squares means|-0.1|STANDARD_ERROR_OF_MEAN|0.21||0.6993|TWO_SIDED|95.0|-0.5|0.3|||ANCOVA|||General activity: Placebo vs DS-5565 15 mg QD||0.3|-0.5|0.6993
72547325|NCT02146430|144623958|SUPERIORITY||Difference in least squares means|0.0|STANDARD_ERROR_OF_MEAN|0.21||0.8702|TWO_SIDED|95.0|-0.4|0.4|||ANCOVA|||General activity: Placebo vs DS-5565 15 mg BID||0.4|-0.4|0.8702
72547326|NCT02146430|144623958|SUPERIORITY||Difference in least squares means|0.3|STANDARD_ERROR_OF_MEAN|0.2||0.1826|TWO_SIDED|95.0|-0.1|0.7|||ANCOVA|||General activity: Pregabalin 150 mg BID vs DS-5565 15 mg QD||0.7|-0.1|0.1826
72547327|NCT02146430|144623958|SUPERIORITY||Difference in least squares means|0.3|STANDARD_ERROR_OF_MEAN|0.21||0.1206|TWO_SIDED|95.0|-0.1|0.7|||ANCOVA|||General activity: Pregabalin 150 mg BID vs DS-5565 15 mg BID||0.7|-0.1|0.1206
72547328|NCT02146430|144623958|SUPERIORITY||Difference in least squares means|-0.5|STANDARD_ERROR_OF_MEAN|0.21||0.0211|TWO_SIDED|95.0|-0.9|-0.1|||ANCOVA|||Mood: Placebo vs Pregabalin 150 mg BID||-0.1|-0.9|0.0211
72547329|NCT02146430|144623958|SUPERIORITY||Difference in least squares means|-0.1|STANDARD_ERROR_OF_MEAN|0.21||0.4963|TWO_SIDED|95.0|-0.6|0.3|||ANCOVA|||Mood: Placebo vs DS-5565 15 mg QD||0.3|-0.6|0.4963
72547330|NCT02146430|144623958|SUPERIORITY||Difference in least squares means|-0.2|STANDARD_ERROR_OF_MEAN|0.21||0.3031|TWO_SIDED|95.0|-0.6|0.2|||ANCOVA|||Mood: Placebo vs DS-5565 15 mg BID||0.2|-0.6|0.3031
72547331|NCT02146430|144623958|SUPERIORITY||Difference in least squares means|0.3|STANDARD_ERROR_OF_MEAN|0.21||0.1019|TWO_SIDED|95.0|-0.1|0.8|||ANCOVA|||Mood: Pregabalin 150 mg BID vs DS-5565 15 mg QD||0.8|-0.1|0.1019
72547332|NCT02146430|144623958|SUPERIORITY||Difference in least squares means|0.3|STANDARD_ERROR_OF_MEAN|0.21||0.201|TWO_SIDED|95.0|-0.1|0.7|||ANCOVA|||Mood: Pregabalin 150 mg BID vs DS-5565 15 mg BID||0.7|-0.1|0.2010
72547333|NCT02146430|144623958|SUPERIORITY||Difference in least squares means|-0.4|STANDARD_ERROR_OF_MEAN|0.21||0.0331|TWO_SIDED|95.0|-0.9|0.0|||ANCOVA|||Walking ability: Placebo vs Pregabalin 150 mg BID||-0.0|-0.9|0.0331
72547334|NCT02146430|144623958|SUPERIORITY||Difference in least squares means|-0.1|STANDARD_ERROR_OF_MEAN|0.21||0.7478|TWO_SIDED|95.0|-0.5|0.3|||ANCOVA|||Walking ability: Placebo vs DS-5565 15 mg QD||0.3|-0.5|0.7478
72547335|NCT02146430|144623958|SUPERIORITY||Difference in least squares means|-0.1|STANDARD_ERROR_OF_MEAN|0.21||0.694|TWO_SIDED|95.0|-0.5|0.3|||ANCOVA|||Walking ability: Placebo vs DS-5565 15 mg BID||0.3|-0.5|0.6940
72547336|NCT02146430|144623958|SUPERIORITY||Difference in least squares means|0.4|STANDARD_ERROR_OF_MEAN|0.21||0.069|TWO_SIDED|95.0|0.0|0.8|||ANCOVA|||Walking ability: Pregabalin 150 mg BID vs DS-5565 15 mg QD||0.8|-0.0|0.0690
72547337|NCT02146430|144623958|SUPERIORITY||Difference in least squares means|0.4|STANDARD_ERROR_OF_MEAN|0.21||0.0816|TWO_SIDED|95.0|0.0|0.8|||ANCOVA|||Walking ability: Pregabalin 150 mg BID vs DS-5565 15 mg BID||0.8|-0.0|0.0816
72547338|NCT02146430|144623958|SUPERIORITY||Difference in least squares means|-0.3|STANDARD_ERROR_OF_MEAN|0.21||0.1174|TWO_SIDED|95.0|-0.7|0.1|||ANCOVA|||Normal work: Placebo vs Pregabalin 150 mg BID||0.1|-0.7|0.1174
72547339|NCT02146430|144623958|SUPERIORITY||Difference in least squares means|0.0|STANDARD_ERROR_OF_MEAN|0.21||0.925|TWO_SIDED|95.0|-0.4|0.4|||ANCOVA|||Normal work: Placebo vs DS-5565 15 mg QD||0.4|-0.4|0.9250
72547340|NCT02146430|144623958|SUPERIORITY||Difference in least squares means|0.0|STANDARD_ERROR_OF_MEAN|0.21||0.8555|TWO_SIDED|95.0|-0.4|0.4|||ANCOVA|||Normal work: Placebo vs DS-5565 15 mg BID||0.4|-0.4|0.8555
72547341|NCT02146430|144623958|SUPERIORITY||Difference in least squares means|0.3|STANDARD_ERROR_OF_MEAN|0.21||0.0956|TWO_SIDED|95.0|-0.1|0.7|||ANCOVA|||Normal work: Pregabalin 150 mg BID vs DS-5565 15 mg QD||0.7|-0.1|0.0956
72547342|NCT02146430|144623958|SUPERIORITY||Difference in least squares means|0.3|STANDARD_ERROR_OF_MEAN|0.21||0.1659|TWO_SIDED|95.0|-0.1|0.7|||ANCOVA|||Normal work: Pregabalin 150 mg BID vs DS-5565 15 mg BID||0.7|-0.1|0.1659
72547343|NCT02146430|144623958|SUPERIORITY||Difference in least squares means|-0.4|STANDARD_ERROR_OF_MEAN|0.21||0.0468|TWO_SIDED|95.0|-0.8|0.0|||ANCOVA|||Relations with other people: Placebo vs Pregabalin 150 mg BID||-0.0|-0.8|0.0468
72547344|NCT02146430|144623958|SUPERIORITY||Difference in least squares means|-0.3|STANDARD_ERROR_OF_MEAN|0.21||0.1083|TWO_SIDED|95.0|-0.7|0.1|||ANCOVA|||Relations with other people: Placebo vs DS-5565 15 mg QD||0.1|-0.7|0.1083
72547345|NCT02146430|144623958|SUPERIORITY||Difference in least squares means|-0.4|STANDARD_ERROR_OF_MEAN|0.21||0.0505|TWO_SIDED|95.0|-0.8|0.0|||ANCOVA|||Relations with other people: Placebo vs DS-5565 15 mg BID||0.0|-0.8|0.0505
72547346|NCT02146430|144623958|SUPERIORITY||Difference in least squares means|0.1|STANDARD_ERROR_OF_MEAN|0.21||0.6993|TWO_SIDED|95.0|-0.3|0.5|||ANCOVA|||Relations with other people: Pregabalin 150 mg BID vs DS-5565 15 mg QD||0.5|-0.3|0.6993
72547347|NCT02146430|144623958|SUPERIORITY||Difference in least squares means|0.0|STANDARD_ERROR_OF_MEAN|0.21||0.9781|TWO_SIDED|95.0|-0.4|0.4|||ANCOVA|||Relations with other people: Pregabalin 150 mg BID vs DS-5565 15 mg BID||0.4|-0.4|0.9781
72547348|NCT02146430|144623958|SUPERIORITY||Difference in least squares means|-0.6|STANDARD_ERROR_OF_MEAN|0.23||0.0154|TWO_SIDED|95.0|-1.0|-0.1|||ANCOVA|||Sleep: Placebo vs Pregabalin 150 mg BID||-0.1|-1.0|0.0154
72547349|NCT02146430|144623958|SUPERIORITY||Difference in least squares means|-0.4|STANDARD_ERROR_OF_MEAN|0.23||0.0731|TWO_SIDED|95.0|-0.9|0.0|||ANCOVA|||Sleep: Placebo vs DS-5565 15 mg QD||0.0|-0.9|0.0731
72547350|NCT02146430|144623958|SUPERIORITY||Difference in least squares means|-0.5|STANDARD_ERROR_OF_MEAN|0.23||0.0259|TWO_SIDED|95.0|-1.0|-0.1|||ANCOVA|||Sleep: Placebo vs DS-5565 15 mg BID||-0.1|-1.0|0.0259
72547351|NCT02146430|144623958|SUPERIORITY||Difference in least squares means|0.1|STANDARD_ERROR_OF_MEAN|0.23||0.5243|TWO_SIDED|95.0|-0.3|0.6|||ANCOVA|||Sleep: Pregabalin 150 mg BID vs DS-5565 15 mg QD||0.6|-0.3|0.5243
72547352|NCT02146430|144623958|SUPERIORITY||Difference in least squares means|0.0|STANDARD_ERROR_OF_MEAN|0.23||0.8488|TWO_SIDED|95.0|-0.4|0.5|||ANCOVA|||Sleep: Pregabalin 150 mg BID vs DS-5565 15 mg BID||0.5|-0.4|0.8488
72547353|NCT02146430|144623958|SUPERIORITY||Difference in least squares means|-0.2|STANDARD_ERROR_OF_MEAN|0.22||0.2746|TWO_SIDED|95.0|-0.7|0.2|||ANCOVA|||Enjoyment of life: Placebo vs Pregabalin 150 mg BID||0.2|-0.7|0.2746
72547354|NCT02146430|144623958|SUPERIORITY||Difference in least squares means|0.0|STANDARD_ERROR_OF_MEAN|0.22||0.9349|TWO_SIDED|95.0|-0.4|0.4|||ANCOVA|||Enjoyment of life: Placebo vs DS-5565 15 mg QD||0.4|-0.4|0.9349
72547355|NCT02146430|144623958|SUPERIORITY||Difference in least squares means|0.1|STANDARD_ERROR_OF_MEAN|0.22||0.5164|TWO_SIDED|95.0|-0.3|0.6|||ANCOVA|||Enjoyment of life: Placebo vs DS-5565 15 mg BID||0.6|-0.3|0.5164
72547356|NCT02146430|144623958|SUPERIORITY||Difference in least squares means|0.3|STANDARD_ERROR_OF_MEAN|0.22||0.2382|TWO_SIDED|95.0|-0.2|0.7|||ANCOVA|||Enjoyment of life: Pregabalin 150 mg BID vs DS-5565 15 mg QD||0.7|-0.2|0.2382
72547357|NCT02146430|144623958|SUPERIORITY||Difference in least squares means|0.4|STANDARD_ERROR_OF_MEAN|0.22||0.0807|TWO_SIDED|95.0|0.0|0.8|||ANCOVA|||Enjoyment of life: Pregabalin 150 mg BID vs DS-5565 15 mg BID||0.8|-0.0|0.0807
72547358|NCT02146430|144623959|SUPERIORITY||Difference in least squares means|-0.045|STANDARD_ERROR_OF_MEAN|0.0237||0.0601|TWO_SIDED|95.0|-0.091|0.002|||ANCOVA|||||0.002|-0.091|0.0601
72581111|NCT03135015|144691712|OTHER||Percentage Change from Control|-8.53||||0.5827|TWO_SIDED||||||t-test, 2 sided|||The blinded AUC results for the 6 treatments will be subjected to repeated measures analysis of variance (ANOVA) examining for the main effects of treatment and participant-group, and treatment\*group interaction. After demonstration of significant heterogeneity among the 6 coded treatments, differences between individual means will be assessed using Tukey's test to adjust for multiple comparisons.||||0.5827
72581112|NCT03135015|144691712|OTHER||Percentage Change from Control|9.32||||0.5485|TWO_SIDED||||||t-test, 2 sided|||The blinded AUC results for the 6 treatments will be subjected to repeated measures analysis of variance (ANOVA) examining for the main effects of treatment and participant-group, and treatment\*group interaction. After demonstration of significant heterogeneity among the 6 coded treatments, differences between individual means will be assessed using Tukey's test to adjust for multiple comparisons.||||0.5485
72581113|NCT03135015|144691713|OTHER|||||||0.1234|||||||t-test, 2 sided|||||||0.1234
72581114|NCT03135015|144691713|OTHER|||||||0.0331|||||||t-test, 2 sided|||||||0.0331
72581115|NCT03135015|144691714|OTHER||||||<|0.05|||||||t-test, 2 sided|||||||<0.0500
72581116|NCT03135015|144691714|OTHER|||||||0.0568|||||||t-test, 2 sided|||||||0.0568
72581117|NCT03135015|144691715|OTHER|||||||0.0509|||||||t-test, 2 sided|||||||0.0509
72581118|NCT03135015|144691715|OTHER|||||||0.5016|||||||t-test, 2 sided|||||||0.5016
72581119|NCT03135015|144691716|OTHER|||||||0.8444|||||||t-test, 2 sided|||||||0.8444
72581120|NCT03135015|144691716|OTHER|||||||0.9681|||||||t-test, 2 sided|||||||0.9681
72581121|NCT03135015|144691716|OTHER|||||||0.1022|||||||t-test, 2 sided|||||||.1022
72581122|NCT03135015|144691716|OTHER|||||||0.3738|||||||t-test, 2 sided|||||||.3738
72581123|NCT03135015|144691716|OTHER||Mean Difference (Net)|-13.123|STANDARD_ERROR_OF_MEAN|8.55|||TWO_SIDED||||||||Percentage Change from Control|||||
72581124|NCT03135015|144691716|OTHER||Mean Difference (Net)|-10.362|STANDARD_ERROR_OF_MEAN|10.387|||TWO_SIDED||||||||Percentage Change from Control|||||
72581125|NCT03135015|144691716|OTHER||Mean Difference (Net)|-13.738|STANDARD_ERROR_OF_MEAN|13.463|||TWO_SIDED||||||||Percentage Change from Control|||||
72581126|NCT03135015|144691716|OTHER||Mean Difference (Net)|-12.929|STANDARD_ERROR_OF_MEAN|14.282|||TWO_SIDED||||||||Percentage Change from Control|||||
72581127|NCT03135015|144691717|OTHER|||||||0.0111|||||||t-test, 2 sided|||||||0.0111
72581128|NCT03135015|144691717|OTHER|||||||0.1684|||||||t-test, 2 sided|||||||0.1684
72581129|NCT03135015|144691717|OTHER||Mean Difference (Net)|-11.604|STANDARD_ERROR_OF_MEAN|6.722|||TWO_SIDED||||||||Percentage Change from Control|||||
72581130|NCT03135015|144691717|OTHER||Mean Difference (Net)|12.755|STANDARD_ERROR_OF_MEAN|8.489|||TWO_SIDED||||||||Percentage Change from Control|||||
72581131|NCT03135015|144691717|OTHER||Mean Difference (Net)|-13.293|STANDARD_ERROR_OF_MEAN|9.664|||TWO_SIDED||||||||Percentage Change from Control|||||
72581132|NCT03135015|144691717|OTHER||Mean Difference (Net)|2.526|STANDARD_ERROR_OF_MEAN|5.813|||TWO_SIDED||||||||Percentage Change from Control|||||
72581133|NCT03135015|144691718|OTHER||Percentage Change from Control|-21.09||||0.0374|TWO_SIDED||||||t-test, 2 sided|||||||0.0374
72581134|NCT03135015|144691719|OTHER||Percentage Change from Control|-24.22||||0.0098|TWO_SIDED||||||t-test, 2 sided|||||||0.0098
72581135|NCT03135015|144691719|OTHER||Percentage Change from Control|-25.02||||0.0391|TWO_SIDED||||||t-test, 2 sided|||||||0.0391
72581136|NCT03135015|144691720|OTHER||Percentage Change from Control|-36.28||||0.0034|TWO_SIDED||||||t-test, 2 sided|||Change from baseline (CFB) in blood glucose will be computed at 90 minutes. The CFB results for the capsule treatments and the water control will be subjected to a paired t-test examining whether the mean difference between the two sets of observations is equal to zero.||||0.0034
72581137|NCT03135015|144691720|OTHER||Percentage Change from Control|-33.21||||0.0058|TWO_SIDED||||||t-test, 2 sided|||Change from baseline (CFB) in blood glucose will be computed at 90 minutes. The CFB results for the capsule treatments and the water control will be subjected to a paired t-test examining whether the mean difference between the two sets of observations is equal to zero.||||0.0058
72581138|NCT03135015|144691720|OTHER||Percentage Change from Control|-53.27||||0.0016|TWO_SIDED||||||t-test, 2 sided|||Change from baseline (CFB) in blood glucose will be computed at 120 minutes. The CFB results for the capsule treatments and the water control will be subjected to a paired t-test examining whether the mean difference between the two sets of observations is equal to zero.||||0.0016
72581139|NCT03135015|144691720|OTHER||Percentage Change from Control|-46.19||||0.0125|TWO_SIDED||||||t-test, 2 sided|||Change from baseline (CFB) in blood glucose will be computed at 120 minutes. The CFB results for the capsule treatments and the water control will be subjected to a paired t-test examining whether the mean difference between the two sets of observations is equal to zero.||||0.0125
72581140|NCT03135015|144691721|OTHER||Percentage Change from Control|-31.36||||0.0788|TWO_SIDED||||||t-test, 2 sided|||Change from baseline (CFB) in blood glucose will be computed at 90 minutes. The CFB results for the capsule treatments and the water control will be subjected to a paired t-test examining whether the mean difference between the two sets of observations is equal to zero.||||0.0788
72581141|NCT03135015|144691721|OTHER||Percentage Change from Control|-30.32||||0.0887|TWO_SIDED||||||t-test, 2 sided|||Change from baseline (CFB) in blood glucose will be computed at 90 minutes. The CFB results for the capsule treatments and the water control will be subjected to a paired t-test examining whether the mean difference between the two sets of observations is equal to zero.||||0.0887
72581142|NCT03135015|144691721|OTHER||Percentage Change from Control|-39.96||||0.0266|TWO_SIDED||||||t-test, 2 sided|||Change from baseline (CFB) in blood glucose will be computed at 120 minutes. The CFB results for the capsule treatments and the water control will be subjected to a paired t-test examining whether the mean difference between the two sets of observations is equal to zero.||||0.0266
72581143|NCT03135015|144691721|OTHER||Percentage Change from Control|-41.8||||0.0455|TWO_SIDED||||||t-test, 2 sided|||Change from baseline (CFB) in blood glucose will be computed at 120 minutes. The CFB results for the capsule treatments and the water control will be subjected to a paired t-test examining whether the mean difference between the two sets of observations is equal to zero.||||0.0455
72547359|NCT02146430|144623959|SUPERIORITY||Difference in least squares means|-0.005|STANDARD_ERROR_OF_MEAN|0.0237||0.8299|TWO_SIDED|95.0|-0.052|0.041|||ANCOVA|||||0.041|-0.052|0.8299
72547360|NCT02146430|144623959|SUPERIORITY||Difference in least squares means|-0.05|STANDARD_ERROR_OF_MEAN|0.0237||0.0347|TWO_SIDED|95.0|-0.096|0.004|||ANCOVA|||||0.004|-0.096|0.0347
72547361|NCT02146430|144623959|SUPERIORITY||Difference in least squares means|0.04|STANDARD_ERROR_OF_MEAN|0.0237||0.0951|TWO_SIDED|95.0|-0.007|0.086|||ANCOVA|||||0.086|-0.007|0.0951
72581144|NCT03135015|144691722|OTHER||Percentage Change from Control|-41.82||||0.0261|TWO_SIDED||||||t-test, 2 sided|||Change from baseline (CFB) in blood glucose will be computed at 90 minutes. The CFB results for the capsule treatments and the water control will be subjected to a paired t-test examining whether the mean difference between the two sets of observations is equal to zero.||||0.0261
72581145|NCT03135015|144691722|OTHER||Percentage Change from Control|-36.45||||0.0391|TWO_SIDED||||||t-test, 2 sided|||Change from baseline (CFB) in blood glucose will be computed at 90 minutes. The CFB results for the capsule treatments and the water control will be subjected to a paired t-test examining whether the mean difference between the two sets of observations is equal to zero.||||0.0391
72581146|NCT03135015|144691722|OTHER||Percentage Change from Control|-82.11||||0.0372|TWO_SIDED||||||t-test, 2 sided|||Change from baseline (CFB) in blood glucose will be computed at 120 minutes. The CFB results for the capsule treatments and the water control will be subjected to a paired t-test examining whether the mean difference between the two sets of observations is equal to zero.||||0.0372
72547362|NCT02146430|144623959|SUPERIORITY||Difference in least squares means|-0.005|STANDARD_ERROR_OF_MEAN|0.0237||0.8199|TWO_SIDED|95.0|-0.052|0.041|||ANCOVA|||||0.041|-0.052|0.8199
72547363|NCT01893905|144623960|SUPERIORITY_OR_OTHER||||||<|0.0307|||||||Pocock approach|||||||<0.0307
72547364|NCT04583579|144623997|SUPERIORITY|||||||0.78|||||||Wilcoxon (Mann-Whitney)|||||||0.78
72547365|NCT02743702|144624080|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
72581147|NCT03135015|144691722|OTHER||Percentage Change from Control|-55.81||||0.1631|TWO_SIDED||||||t-test, 2 sided|||Change from baseline (CFB) in blood glucose will be computed at 120 minutes. The CFB results for the capsule treatments and the water control will be subjected to a paired t-test examining whether the mean difference between the two sets of observations is equal to zero.||||0.1631
72581148|NCT03135015|144691723|OTHER||Percentage Change from Control|-46.43||||0.0303|TWO_SIDED||||||t-test, 2 sided|||Change from baseline (CFB) in insulin will be computed at 90 minutes. The CFB results for the capsule treatments and the water control will be subjected to a paired t-test examining whether the mean difference between the two sets of observations is equal to zero.||||0.0303
72547366|NCT02396381|144624092|OTHER||LS Mean Difference|3.09|||<|0.001|TWO_SIDED|96.875|1.1|5.09|||Hailperin-Rüger|p-value less than 1.5625% would be considered statistically significant, following test multiplicity adjustment using the Hailperin-Rüger approach||"The analysis will test if the mean level of HDL-C for THS-use is greater than for CC-use. The following hypothesis will be evaluated:~H0: XTHS - XCC ≤ 0.0~HA: XTHS - XCC \> 0.0~where XTHS and XCC are the adjusted means of THS-use and CC-use, respectively. H0 is rejected with a type I error α = 1.5625% (one-sided test)."||5.09|1.10|<0.001
72547367|NCT02396381|144624093|SUPERIORITY||LS Mean Difference|-0.42||||0.001|TWO_SIDED|96.875|-0.717|-0.123|||Hailperin-Rüger|p-value less than 1.5625% would be considered statistically significant, following test multiplicity adjustment using the Hailperin-Rüger approach||"The analysis will test if the mean level of WBC for THS-use is lower than for CC-use. The following hypothesis will be evaluated:~H0: XTHS - XCC ≥ 0.0~HA: XTHS - XCC \< 0.0~where XTHS and XCC are the adjusted means of THS-use and CC-use, respectively. H0 is rejected with a type I error α = 1.5625% (one-sided test)."||-0.123|-0.717|0.001
72547368|NCT02396381|144624094|SUPERIORITY||LS Mean Difference|1.28||||0.008|TWO_SIDED|96.875|0.145|2.42|||Hailperin-Rüger|p-value less than 1.5625% would be considered statistically significant, following test multiplicity adjustment using the Hailperin-Rüger approach||"The analysis will test if the mean level of FEV1 for THS-use is greater than for CC-use. The following hypothesis will be evaluated:~H0: XTHS - XCC ≤ 0.0~HA: XTHS - XCC \> 0.0~where XTHS and XCC are the adjusted means of THS-use and CC-use, respectively. H0 is rejected with a type I error α = 1.5625% (one-sided test)."||2.42|0.145|0.008
72547369|NCT02396381|144624095|SUPERIORITY||% Reduction|2.86||||0.03|TWO_SIDED|96.875|-0.426|6.04|||Hailperin-Rüger|p-value less than 1.5625% would be considered statistically significant, following test multiplicity adjustment using the Hailperin-Rüger approach|Derived as 1 - LS Mean Ratio (THS / CC)|"The analysis of sICAM-1 will test if the mean level of this clinical risk endpoint for THS-use is lower relative to CC-use. The following hypothesis will be evaluated:~H0: XTHS / XCC ≥ 1.0~HA: XTHS / XCC \< 1.0~where XTHS and XCC are the adjusted geometrical means of THS-use and CC-use, respectively. H0 is rejected with a type I error α = 1.5625% (one-sided test)."||6.04|-0.426|0.030
72547370|NCT02396381|144624096|SUPERIORITY||% Reduction|4.74||||0.193|TWO_SIDED|96.875|-7.5|15.6|||Hailperin-Rüger|p-value less than 1.5625% would be considered statistically significant, following test multiplicity adjustment using the Hailperin-Rüger approach|Derived as 1 - LS Mean Ratio (THS / CC)|"The analysis of 11-DTX-B2 will test if the mean level of this clinical risk endpoint for THS-use is lower relative to CC-use. The following hypothesis will be evaluated:~H0: XTHS / XCC ≥ 1.0~HA: XTHS / XCC \< 1.0~where XTHS and XCC are the adjusted geometrical means of THS-use and CC-use, respectively. H0 is rejected with a type I error α = 1.5625% (one-sided test)."||15.6|-7.5|0.193
72547371|NCT02396381|144624097|SUPERIORITY||% Reduction|6.8||||0.018|TWO_SIDED|96.875|-0.216|13.3|||Hailperin-Rüger|p-value less than 1.5625% would be considered statistically significant, following test multiplicity adjustment using the Hailperin-Rüger approach|Derived as 1 - LS Mean Ratio (THS / CC)|"The analysis of 8-epi-PGF2α will test if the mean level of this clinical risk endpoint for THS-use is lower relative to CC-use. The following hypothesis will be evaluated:~H0: XTHS / XCC ≥ 1.0~HA: XTHS / XCC \< 1.0~where XTHS and XCC are the adjusted geometrical means of THS-use and CC-use, respectively. H0 is rejected with a type I error α = 1.5625% (one-sided test)."||13.3|-0.216|0.018
72552696|NCT00322465|144636213|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.0||||0.164|TWO_SIDED|95.0|0.75|5.33||A priori threshold for statistical significance was p\<0.05.|Regression, Logistic|Odds ratio has been adjusted for other independent variables included in the model, which are found in the other Statistical Analysis sections.||The null hypothesis is that the odds ratio for moderate discharge amount (reference category is no discharge) is 1 versus the alternative that it is greater than or less than 1. This was tested in a multivariable logistic regression model.||5.33|0.75|0.164
72552697|NCT00322465|144636213|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.09||||0.919|TWO_SIDED|95.0|0.23|5.17||A priori threshold for statistical significance was p\<0.05.|Regression, Logistic|Odds ratio has been adjusted for other independent variables included in the model, which are found in the other Statistical Analysis sections.||The null hypothesis is that the odds ratio for large amount of discharge (reference category is no discharge) is 1 versus the alternative that it is greater than or less than 1. This was tested in a multvariable logistic regression model.||5.17|0.23|0.919
72552698|NCT00322465|144636213|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.81||||0.051|TWO_SIDED|95.0|1.0|3.3||A priori threshold for statistical significance was p\<0.05.|Regression, Logistic|Odds ratio has been adjusted for other independent variables included in the model, which are found in the other Statistical Analysis sections.||The null hypothesis is that the odds ratio for 2 or more sex partners in the last 3 months (reference category is 0-1 partners) is 1 versus the alternative that it is greater than or less than 1.||3.30|1.00|0.051
72552699|NCT00322465|144636213|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.42||||0.076|TWO_SIDED|95.0|0.86|22.74||A priori threshold for statistical significance was p\<0.05|Regression, Logistic|Odds ratio has been adjusted for other independent variables included in the model, which are found in the other Statistical Analysis sections.||The null hypothesis is that the odds ratio for 1 or more new sex partners in the last 30 days (reference category is 0) is 1 versus the alternative that it is greater than or less than 1.||22.74|0.86|0.076
72552700|NCT00322465|144636213|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.38||||0.075|TWO_SIDED|95.0|0.13|1.1||A priori threshold fors tatistical significance was p\<0.05.|Regression, Logistic|Odds ratio has been adjusted for other independent variables included in the model, which are found in the other Statistical Analysis sections.||The null hypothesis is that the odds ratio for ever having sex with a prostitute or sex for money, drugs, or other things (reference category is no) is 1 versus the alternative that it is greater than or less than 1.||1.10|0.13|0.075
72547372|NCT02396381|144624098|SUPERIORITY||% Reduction|43.5|||<|0.001|TWO_SIDED|96.875|33.7|51.9|||Hailperin-Rüger|p-value less than 1.5625% would be considered statistically significant, following test multiplicity adjustment using the Hailperin-Rüger approach|Derived as 1 - LS Mean Ratio (THS / CC)|"The analysis of Total NNAL will test if the mean level of this clinical risk endpoint for THS-use is lower relative to CC-use. The following hypothesis will be evaluated:~H0: XTHS / XCC ≥ 1.0~HA: XTHS / XCC \< 1.0~where XTHS and XCC are the adjusted geometrical means of THS-use and CC-use, respectively. H0 is rejected with a type I error α = 1.5625% (one-sided test)."||51.9|33.7|<0.001
72547373|NCT02396381|144624099|SUPERIORITY||% Reduction|32.2|||<|0.001|TWO_SIDED|96.875|24.5|39.0|||Hailperin-Rüger|p-value less than 1.5625% would be considered statistically significant, following test multiplicity adjustment using the Hailperin-Rüger approach|Derived as 1 - LS Mean Ratio (THS / CC)|"The analysis will test if the mean level of COHb for THS-use is lower relative to CC-use. The following hypothesis will be evaluated:~H0: XTHS / XCC ≥ 1.0~HA: XTHS / XCC \< 1.0~where XTHS and XCC are the adjusted geometrical means of THS-use and CC-use. H0 is rejected with a type I error α = 1.5625% (one-sided test)."||39|24.5|<0.001
72547374|NCT03197064|144624100|OTHER|||||||0.35|||||||t-test, 2 sided|||Difference in left upper extremity amplitude between baseline (pre-dose) and 30 minutes post-dose||||0.35
72547375|NCT03197064|144624100|OTHER|||||||0.47|||||||t-test, 2 sided|||Difference in left upper extremity amplitude between baseline (pre-dose) and 60 minutes post-dose||||0.47
72547376|NCT03197064|144624100|OTHER|||||||0.066|||||||t-test, 2 sided|||Difference in left upper extremity amplitude between baseline (pre-dose) and 90 minutes post-dose||||0.066
72547377|NCT03197064|144624101|OTHER|||||||0.72|||||||t-test, 2 sided|||Difference in right upper extremity amplitude between baseline (pre-dose) and 30 minutes post-dose||||0.72
72547378|NCT03197064|144624101|OTHER|||||||0.72|||||||t-test, 2 sided|||Difference in right upper extremity amplitude between baseline (pre-dose) and 60 minutes post-dose||||0.72
72547379|NCT03197064|144624101|OTHER|||||||0.78|||||||t-test, 2 sided|||Difference in right upper extremity amplitude between baseline (pre-dose) and 90 minutes post-dose||||0.78
72547380|NCT03197064|144624102|OTHER|||||||0.93|||||||t-test, 2 sided|||Difference in left lower extremity amplitude between baseline (pre-dose) and 30 minutes post-dose||||0.93
72547381|NCT03197064|144624102|OTHER|||||||0.39|||||||t-test, 2 sided|||Difference in left lower extremity amplitude between baseline (pre-dose) and 60 minutes post-dose||||0.39
72581149|NCT03135015|144691723|OTHER||Percentage Change from Control|-19.64||||0.4283|TWO_SIDED||||||t-test, 2 sided|||Change from baseline (CFB) in insulin will be computed at 90 minutes. The CFB results for the capsule treatments and the water control will be subjected to a paired t-test examining whether the mean difference between the two sets of observations is equal to zero.||||0.4283
72547382|NCT03197064|144624102|OTHER|||||||0.08|||||||t-test, 2 sided|||Difference in left lower extremity amplitude between baseline (pre-dose) and 90 minutes post-dose||||0.08
72547383|NCT03197064|144624103|OTHER|||||||0.42|||||||t-test, 2 sided|||Difference in right lower extremity amplitude between baseline (pre-dose) and 30 minutes post-dose||||0.42
72547384|NCT03197064|144624103|OTHER|||||||0.37|||||||t-test, 2 sided|||Difference in right lower extremity amplitude between baseline (pre-dose) and 60 minutes post-dose||||0.37
72547385|NCT03197064|144624103|OTHER|||||||0.49|||||||t-test, 2 sided|||Difference in right lower extremity amplitude between baseline (pre-dose) and 90 minutes post-dose||||0.49
72547386|NCT03197064|144624104|OTHER|||||||0.386|||||||t-test, 2 sided|||Difference in left upper extremity amplitude between baseline (pre-dose) and 30 minutes post-dose||||0.386
72547387|NCT03197064|144624104|OTHER|||||||0.388|||||||t-test, 2 sided|||Difference in left upper extremity amplitude between baseline (pre-dose) and 60 minutes post-dose||||0.388
72547388|NCT03197064|144624104|OTHER|||||||0.247|||||||t-test, 2 sided|||Difference in left upper extremity amplitude between baseline (pre-dose) and 90 minutes post-dose||||0.247
72547389|NCT01884025|144624131|SUPERIORITY_OR_OTHER|||||||0.59|||||||t-test, 2 sided|t-Value: 0.55||Change in total BADS score.||||0.59
72547390|NCT01884025|144624131|SUPERIORITY|||||||0.98|||||||t-test, 2 sided|t Value: 0.03||Change in Activation Subscale||||0.98
72547391|NCT01884025|144624131|SUPERIORITY|||||||0.96|||||||t-test, 2 sided|"DF: 18~1 Value: -0.04"||Change in Avoidance/Rumination Subscale||||0.96
72547392|NCT01884025|144624131|SUPERIORITY|||||||0.21|||||||t-test, 2 sided|t Value: 1.31||Change in Work/School Impairment Subscale||||0.21
72547393|NCT01884025|144624131|SUPERIORITY|||||||0.34|||||||t-test, 2 sided|t Value: 0.99||Change in Social Impairment Subscale||||0.34
72547394|NCT01884025|144624132|SUPERIORITY|||||||0.75|||||||t-test, 2 sided|t Value: 0.33||||||0.75
72547395|NCT01884025|144624133|SUPERIORITY_OR_OTHER|||||||0.72|||||||t-test, 2 sided|t Value: -0.36||Change in overall physical activity frequency were compared between the two groups.||||0.72
72547396|NCT01884025|144624133|SUPERIORITY|||||||0.7|||||||t-test, 2 sided|t Value: -0.39||Change in moderate physical activity frequency between the two groups.||||0.70
72547397|NCT01884025|144624134|SUPERIORITY|||||||0.45|ONE_SIDED|95.0|||||t-test, 2 sided|t Value: 0.77||Change in the physical health scale of the RAND 12 were compared.||||0.45
72547398|NCT01884025|144624134|SUPERIORITY|||||||0.45|||||||t-test, 2 sided|t Value: 0.76||Change in the mental health scale of the RAND 12 were compared.||||0.45
72547399|NCT01884025|144624135|SUPERIORITY_OR_OTHER|||||||0.72|||||||t-test, 2 sided|t Value: -0.36||||||0.72
72547400|NCT01884025|144624136|SUPERIORITY|||||||0.88|||||||t-test, 2 sided|t Value: 0.15||||||0.88
72547401|NCT01884025|144624137|SUPERIORITY|||||||0.08|ONE_SIDED|95.0|||||t-test, 2 sided|t Value: 1.83||||||.08
72547402|NCT01884025|144624138|SUPERIORITY|||||||0.16||||||Chi Squared 1.98|Chi-squared|||||||.16
72547403|NCT01884025|144624139|SUPERIORITY|||||||0.85||||||t value: .19|t-test, 2 sided|||||||.85
72547404|NCT01884025|144624140|SUPERIORITY|||||||0.6||||||t value: .54|t-test, 2 sided|||||||.60
72547405|NCT01884025|144624141|SUPERIORITY|||||||0.26||||||t value: -1.17|t-test, 2 sided|||||||.26
72581150|NCT01197911|144691739|SUPERIORITY_OR_OTHER||Geometric Least-Squares Mean Ratio|1.148|||||TWO_SIDED|90.0|0.9293|1.4182||||||This statistical analysis consisted of all evaluable hepatic impaired participants for whom at least one evaluable matching healthy participant was available.||1.4182|0.9293|
72547406|NCT01884025|144624142|SUPERIORITY|||||||0.08||||||t value: 1.85|t-test, 2 sided|||||||.08
72547407|NCT02059993|144624147|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|10.0|||<|0.05|TWO_SIDED|95.0|||||t-test, 2 sided|||The sample size was calculated to assess a minimum reduction of 5 ± 5 mm Hg in systolic BPafter CPAP treatment, assuming an alpha error of 5% and a statistical power of 80%.||||<0.05
72547408|NCT02059993|144624148|OTHER|||||||0.001|||||||t-test, 2 sided|||||||0.001
72547409|NCT02655237|144624150|NON_INFERIORITY|The point estimate and 2-sided 95% confidence interval of the difference in the percentage were calculated between Relugolix 40 mg group and leuprorelin group (Relugolix 40 mg group - leuprorelin group), using Farrington and Manning (FM) method. If the lower boundary of the 95% CI was greater or equal to the non-inferiority margin of -15%, then the non-inferiority of Relugolix 40 mg to leuprorelin was concluded.|Difference in percentage|-0.9||||0.0013|TWO_SIDED|95.0|-10.098|8.346|||Farrington and Manning (FM)||Relugolix 40 mg-Leuprorelin|||8.346|-10.098|0.0013
72547410|NCT02655237|144624151|OTHER|The point estimate and 2-sided 95% confidence interval of the difference in the percentage were calculated between relugolix 40 mg group and leuprorelin group, using FM method with the non-inferiority margin of -15%. The confidence interval was presented in a descriptive manner and not for the purpose of statistical inference.|Difference in percentage|32.5|||||TWO_SIDED|95.0|20.953|44.134|||||Relugolix 40 mg-Leuprorelin|||44.134|20.953|
72581151|NCT01197911|144691739|SUPERIORITY_OR_OTHER||Geometric Least-Squares Mean Ratio|1.5518|||||TWO_SIDED|90.0|1.2468|1.9314||||||This statistical analysis consisted of all evaluable hepatic impaired participants for whom at least one evaluable matching healthy participant was available. One Participant with moderate hepatic impairment was not included in the statistical analysis of the PK parameters as there was no appropriate participant with normal hepatic function match.||1.9314|1.2468|
72581152|NCT01197911|144691741|SUPERIORITY_OR_OTHER||Geometric Least-Squares Mean Ratio|0.9477|||||TWO_SIDED|90.0|0.7908|1.1356||||||This statistical analysis consisted of all evaluable hepatic impaired participants for whom at least one evaluable matching healthy participant was available.||1.1356|0.7908|
72547411|NCT02655237|144624152|OTHER|The point estimate and 2-sided 95% confidence interval of the difference in the percentage were calculated between relugolix 40 mg group and leuprorelin group, using FM method with the non-inferiority margin of -15%. The confidence interval was presented in a descriptive manner and not for the purpose of statistical inference.|Difference in percentage|-10.6|||||TWO_SIDED|95.0|-18.337|-2.883|||||Relugolix 40 mg-Leuprorelin|||-2.883|-18.337|
72547412|NCT02655237|144624153|OTHER|The point estimate and 2-sided 95% confidence interval of the difference in the percentage were calculated between relugolix 40 mg group and leuprorelin group, using FM method with the non-inferiority margin of -15%. The confidence interval was presented in a descriptive manner and not for the purpose of statistical inference.|Difference in percentage|-13.3|||||TWO_SIDED|95.0|-21.418|-5.118|||||Relugolix 40 mg-Leuprorelin|||-5.118|-21.418|
72547413|NCT02655237|144624154|OTHER|The mean differences in the percent changes from baseline between relugolix 40 mg and leuprorelin group and the two-sided 95% confidence intervals were calculated.|Mean Difference (Each Visit)|-12.05|||||TWO_SIDED|95.0|-19.778|-4.33|||||Relugolix 40 mg-Leuprorelin|Week 2||-4.330|-19.778|
72581153|NCT01197911|144691741|SUPERIORITY_OR_OTHER||Geometric Least-Squares Mean Ratio|1.0782|||||TWO_SIDED|90.0|0.8941|1.3002||||||This statistical analysis consisted of all evaluable hepatic impaired participants for whom at least one evaluable matching healthy participant was available. One Participant with moderate hepatic impairment was not included in the statistical analysis of the PK parameters as there was no appropriate participant with normal hepatic function match.||1.3002|0.8941|
72581154|NCT01197911|144691755|SUPERIORITY_OR_OTHER||Geometric Least-Squares Mean Ratio|1.2323|||||TWO_SIDED|90.0|0.9618|1.5789||||||This statistical analysis consisted of all evaluable hepatic impaired participants for whom at least one evaluable matching healthy participant was available.||1.5789|0.9618|
72581155|NCT01197911|144691755|SUPERIORITY_OR_OTHER||Geometric Least-Squares Mean Ratio|1.5587|||||TWO_SIDED|90.0|1.2165|1.9971||||||This statistical analysis consisted of all evaluable hepatic impaired participants for whom at least one evaluable matching healthy participant was available. One participant with moderate hepatic impairment was not included in the statistical analysis of the PK parameters as there was no appropriate participant with normal hepatic function match.||1.9971|1.2165|
72581156|NCT01197911|144691756|SUPERIORITY_OR_OTHER||Geometric Least-Squares Mean Ratio|1.0027|||||TWO_SIDED|90.0|0.8049|1.2492||||||This statistical analysis consisted of all evaluable hepatic impaired participants for whom at least one evaluable matching healthy participant was available.||1.2492|0.8049|
72581157|NCT01197911|144691756|SUPERIORITY_OR_OTHER||GeometricLeast-Squares Mean Ratio|1.2254|||||TWO_SIDED|90.0|0.9836|1.5266||||||This statistical analysis consisted of all evaluable hepatic impaired participants for whom at least one evaluable matching healthy participant was available. One participant with moderate hepatic impairment was not included in the statistical analysis of the PK parameters as there was no appropriate participant with normal hepatic function match.||1.5266|0.9836|
72581158|NCT00951496|144691765|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Study was designed to provide 80% power when arm II reduces the progression free survival event rate 20%. The critical p-value accounts for correlation between 2 primary hypotheses.|Hazard Ratio (HR)|0.94||||0.341|TWO_SIDED|95.0|0.81|1.09||P value not adjusted for multiplicity. Significance Threshold = 0.027|Log Rank|Stratified by stage of disease and size of residual disease.|Progression free survival of arm II relative to arm I. Adjusted for stage of disease and residual size.|P value.(an P value is used to determine statistical significance in a hypothesis test). from a stratified log rank test to assess equality of progression free survival hazards of arm II and arm I||1.09|0.81|0.341
72581159|NCT00951496|144691765|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Study was designed to provide 80% power when arm III reduced the true progression free survival event rate. 20% compared to arm I. Critical p value accounts for correlation between 2 primary hypotheses.|Hazard Ratio (HR)|0.99||||0.587|TWO_SIDED|95.0|0.86|1.15||P value not adjusted for multiplicity. Significance threshold = 0.027 accounting for 2 correlated primary hypotheses.|Log Rank|Stratified by stage of disease and size of residual disease.|Progression free survival hazard of arm III to arm I. Adjusted for stage of disease and residual disease size.|P value from a log rank test comparing the progression free survival hazards of arm III to arm I.||1.15|0.86|0.587
72581160|NCT01526057|144691786|EQUIVALENCE|PK similarity for a given test-to-reference comparison would be demonstrated if the 90% CI for the test-to-reference ratios in Cmax and area under the serum concentration-time curve (AUC) from time 0 extrapolated to infinite time (AUC 0-inf) are within the 80.00% to 125.00% range.|Test-to-reference ratio: adjusted means|105.67|||||TWO_SIDED|90.0|96.91|115.21|||||Rituximab-Pfizer is the numerator.|A 90% CI on the estimated difference between 2 treatment groups was constructed using a 1-way analysis of variance (ANOVA) model based on natural log-transformed data. The estimated differences for the log-transformed PK parameters were then transformed to relative ratios of PK parameters by exponentiation.||115.21|96.91|
72581161|NCT01526057|144691786|EQUIVALENCE|PK similarity for a given test-to-reference comparison would be demonstrated if the 90% CI for the test-to-reference ratios in Cmax and AUC 0-inf are within the 80.00% to 125.00% range.|Test-to-reference ratio: adjusted means|106.62|||||TWO_SIDED|90.0|97.65|116.41|||||Rituximab-Pfizer is the numerator.|A 90% CI on the estimated difference between 2 treatment groups was constructed using a 1-way ANOVA model based on natural log-transformed data. The estimated differences for the log-transformed PK parameters were then transformed to relative ratios of PK parameters by exponentiation.||116.41|97.65|
72581162|NCT01526057|144691786|EQUIVALENCE|PK similarity for a given test-to-reference comparison would be demonstrated if the 90% CI for the test-to-reference ratios in Cmax and AUC 0-inf are within the 80.00% to 125.00% range.|Test-to-reference ratio: adjusted means|100.9|||||TWO_SIDED|90.0|92.38|110.2|||||Rituximab-EU is the numerator.|A 90% CI on the estimated difference between 2 treatment groups was constructed using a 1-way ANOVA model based on natural log-transformed data. The estimated differences for the log-transformed PK parameters were then transformed to relative ratios of PK parameters by exponentiation.||110.20|92.38|
72581163|NCT01526057|144691787|EQUIVALENCE|PK similarity for a given test-to-reference comparison would be demonstrated if the 90% CI for the test-to-reference ratios in Cmax and AUC0-inf are within the 80.00% to 125.00% range.|Test-to-reference ratio: adjusted means|104.19|||||TWO_SIDED|90.0|92.75|117.06||||||A 90% CI on the estimated difference between 2 treatment groups was constructed using a 1-way ANOVA model based on natural log-transformed data. The estimated differences for the log-transformed PK parameters were then transformed to relative ratios of PK parameters by exponentiation.||117.06|92.75|
72581164|NCT01526057|144691787|EQUIVALENCE|PK similarity for a given test-to-reference comparison would be demonstrated if the 90% CI for the test-to-reference ratios in Cmax and AUC0-inf are within the 80.00% to 125.00% range.|Test-to-reference ratio: adjusted means|100.45|||||TWO_SIDED|90.0|89.2|113.11||||||A 90% CI on the estimated difference between 2 treatment groups was constructed using a 1-way ANOVA model based on natural log-transformed data. The estimated differences for the log-transformed PK parameters were then transformed to relative ratios of PK parameters by exponentiation.||113.11|89.20|
72581165|NCT01526057|144691787|EQUIVALENCE|PK similarity for a given test-to-reference comparison would be demonstrated if the 90% CI for the test-to-reference ratios in Cmax and AUC0-inf are within the 80.00% to 125.00% range.|Test-to-reference ratio: adjusted means|96.4|||||TWO_SIDED|90.0|85.57|108.6||||||A 90% CI on the estimated difference between 2 treatment groups was constructed using a 1-way ANOVA model based on natural log-transformed data. The estimated differences for the log-transformed PK parameters were then transformed to relative ratios of PK parameters by exponentiation.||108.60|85.57|
72581166|NCT01526057|144691788|SUPERIORITY||Test-to-reference ratio: adjusted means|103.74|||||TWO_SIDED|90.0|95.1|113.12|||||Rituximab-Pfizer is the numerator.|A 90% CI on the estimated difference between 2 treatment groups was constructed using a 1-way ANOVA model based on natural log-transformed data. The estimated differences for the log-transformed PK parameters were then transformed to relative ratios of PK parameters by exponentiation.||113.12|95.10|
72547414|NCT02655237|144624154|OTHER|The mean differences in the percent changes from baseline between relugolix 40 mg and leuprorelin group and the two-sided 95% confidence intervals were calculated.|Mean Difference (Each Visit)|-2.55|||||TWO_SIDED|95.0|-11.916|6.819|||||Relugolix 40 mg-Leuprorelin|Week 4||6.819|-11.916|
72547415|NCT02655237|144624154|OTHER|The mean differences in the percent changes from baseline between relugolix 40 mg and leuprorelin group and the two-sided 95% confidence intervals were calculated.|Mean Difference (Each Visit)|4.69|||||TWO_SIDED|95.0|-3.141|12.529|||||Relugolix 40 mg-Leuprorelin|Week 8||12.529|-3.141|
72547416|NCT02655237|144624154|OTHER|The mean differences in the percent changes from baseline between relugolix 40 mg and leuprorelin group and the two-sided 95% confidence intervals were calculated.|Mean Difference (Each Visit)|3.59|||||TWO_SIDED|95.0|-3.433|10.605|||||Relugolix 40 mg-Leuprorelin|Week 12||10.605|-3.433|
72547417|NCT02655237|144624154|OTHER|The mean differences in the percent changes from baseline between relugolix 40 mg and leuprorelin group and the two-sided 95% confidence intervals were calculated.|Mean Difference (Each Visit)|3.96|||||TWO_SIDED|95.0|-3.319|11.245|||||Relugolix 40 mg-Leuprorelin|Week 24||11.245|-3.319|
72547418|NCT02655237|144624155|OTHER|The mean differences in the percent changes from baseline between relugolix 40 mg and leuprorelin group and the two-sided 95% confidence intervals were calculated.|Mean Difference (Each Visit)|-15.15|||||TWO_SIDED|95.0|-20.786|-9.509|||||Relugolix 40 mg-Leuprorelin|Week 2||-9.509|-20.786|
72547419|NCT02655237|144624155|OTHER|The mean differences in the percent changes from baseline between relugolix 40 mg and leuprorelin group and the two-sided 95% confidence intervals were calculated.|Mean Difference (Each Visit)|-10.27|||||TWO_SIDED|95.0|-17.291|-3.246|||||Relugolix 40 mg-Leuprorelin|Week 4||-3.246|-17.291|
72547420|NCT02655237|144624155|OTHER|The mean differences in the percent changes from baseline between relugolix 40 mg and leuprorelin group and the two-sided 95% confidence intervals were calculated.|Mean Difference (Each Visit)|-0.89|||||TWO_SIDED|95.0|-6.996|5.209|||||Relugolix 40 mg-Leuprorelin|Week 8||5.209|-6.996|
72547421|NCT02655237|144624155|OTHER|The mean differences in the percent changes from baseline between relugolix 40 mg and leuprorelin group and the two-sided 95% confidence intervals were calculated.|Mean Difference (Each Visit)|-0.94|||||TWO_SIDED|95.0|-6.964|5.076|||||Relugolix 40 mg-Leuprorelin|Week 12||5.076|-6.964|
72547422|NCT02655237|144624155|OTHER|The mean differences in the percent changes from baseline between relugolix 40 mg and leuprorelin group and the two-sided 95% confidence intervals were calculated.|Mean Difference (Each Visit)|0.86|||||TWO_SIDED|95.0|-6.206|7.935|||||Relugolix 40 mg-Leuprorelin|Week 24||7.935|-6.206|
72581167|NCT01526057|144691788|SUPERIORITY||Test-to-reference ratio: adjusted means|105.56|||||TWO_SIDED|90.0|96.64|115.3|||||Rituximab-Pfizer is the numerator.|A 90% CI on the estimated difference between 2 treatment groups was constructed using a 1-way ANOVA model based on natural log-transformed data. The estimated differences for the log-transformed PK parameters were then transformed to relative ratios of PK parameters by exponentiation.||115.30|96.64|
72581168|NCT01526057|144691788|SUPERIORITY||Test-to-reference ratio: adjusted means|101.76|||||TWO_SIDED|90.0|93.13|111.18|||||Rituximab-EU is the numerator.|A 90% CI on the estimated difference between 2 treatment groups was constructed using a 1-way ANOVA model based on natural log-transformed data.||111.18|93.13|
72547423|NCT02655237|144624156|OTHER|The mean differences in the change from baseline between relugolix 40 mg and leuprorelin groups and the two-sided 95% confidence intervals were calculated for each visit.|Mean Difference (Each Visit)|0.2|||||TWO_SIDED|95.0|0.015|0.381|||||Relugolix 40 mg-Leuprorelin|Week 4||0.381|0.015|
72547424|NCT02655237|144624156|OTHER|The mean differences in the change from baseline between relugolix 40 mg and leuprorelin groups and the two-sided 95% confidence intervals were calculated for each visit.|Mean Difference (Each Visit)|0.1|||||TWO_SIDED|95.0|-0.135|0.333|||||Relugolix 40 mg-Leuprorelin|Week 8||0.333|-0.135|
72547425|NCT02655237|144624156|OTHER|The mean differences in the change from baseline between relugolix 40 mg and leuprorelin groups and the two-sided 95% confidence intervals were calculated for each visit.|Mean Difference (Each Visit)|0.07|||||TWO_SIDED|95.0|-0.189|0.323|||||Relugolix 40 mg-Leuprorelin|Week 12||0.323|-0.189|
72581169|NCT01526057|144691789|SUPERIORITY||Test-to-reference ratio: adjusted means|103.36|||||TWO_SIDED|90.0|92.81|115.12||||||A 90% CI on the estimated difference between 2 treatment groups was constructed using a 1-way ANOVA model based on natural log-transformed data. The estimated differences for the log-transformed PK parameters were then transformed to relative ratios of PK parameters by exponentiation.||115.12|92.81|
72581170|NCT01526057|144691789|SUPERIORITY||Test-to-reference ratio: adjusted means|101.33|||||TWO_SIDED|90.0|90.82|113.04||||||A 90% CI on the estimated difference between 2 treatment groups was constructed using a 1-way ANOVA model based on natural log-transformed data. The estimated differences for the log-transformed PK parameters were then transformed to relative ratios of PK parameters by exponentiation.||113.04|90.82|
72581171|NCT01526057|144691789|SUPERIORITY||Test-to-reference ratio: adjusted means|98.03|||||TWO_SIDED|90.0|87.83|109.4||||||A 90% CI on the estimated difference between 2 treatment groups was constructed using a 1-way ANOVA model based on natural log-transformed data. The estimated differences for the log-transformed PK parameters were then transformed to relative ratios of PK parameters by exponentiation.||109.40|87.83|
72581172|NCT01526057|144691808|SUPERIORITY||Risk Ratio (RR)|0.75|||||TWO_SIDED|95.0|0.31|1.78|||||Rituximab-EU is the numerator.|Statistical analysis of rituximab-EU versus rituximab-Pfizer at Week 3.||1.78|0.31|
72581173|NCT01526057|144691808|SUPERIORITY||Risk Ratio (RR)|1.06|||||TWO_SIDED|95.0|0.6|1.88|||||Rituximab-EU is the numerator.|Statistical analysis of rituximab-EU versus rituximab-Pfizer at Week 5.||1.88|0.60|
72581174|NCT01526057|144691808|SUPERIORITY||Risk Ratio (RR)|1.06|||||TWO_SIDED|95.0|0.66|1.73|||||Rituximab-EU is the numerator.|Statistical analysis of rituximab-EU versus rituximab-Pfizer at Week 9.||1.73|0.66|
72581175|NCT01526057|144691808|SUPERIORITY||Risk Ratio (RR)|1.06|||||TWO_SIDED|95.0|0.73|1.56|||||Rituximab-EU is the numerator.|Statistical analysis of rituximab-EU versus rituximab-Pfizer at Week 13.||1.56|0.73|
72581176|NCT01526057|144691808|SUPERIORITY||Risk Ratio (RR)|1.05|||||TWO_SIDED|95.0|0.68|1.62|||||Rituximab-EU is the numerator.|Statistical analysis of rituximab-EU versus rituximab-Pfizer at Week 17.||1.62|0.68|
72547426|NCT02655237|144624156|OTHER|The mean differences in the change from baseline between relugolix 40 mg and leuprorelin groups and the two-sided 95% confidence intervals were calculated for each visit.|Mean Difference (Each Visit)|-0.01|||||TWO_SIDED|95.0|-0.275|0.251|||||Relugolix 40 mg-Leuprorelin|Week 16||0.251|-0.275|
72547427|NCT02655237|144624156|OTHER|The mean differences in the change from baseline between relugolix 40 mg and leuprorelin groups and the two-sided 95% confidence intervals were calculated for each visit.|Mean Difference (Each Visit)|-0.1|||||TWO_SIDED|95.0|-0.386|0.18|||||Relugolix 40 mg-Leuprorelin|Week 20||0.180|-0.386|
72547428|NCT02655237|144624156|OTHER|The mean differences in the change from baseline between relugolix 40 mg and leuprorelin groups and the two-sided 95% confidence intervals were calculated for each visit.|Mean Difference (Each Visit)|-0.09|||||TWO_SIDED|95.0|-0.385|0.209|||||Relugolix 40 mg-Leuprorelin|Week 24||0.209|-0.385|
72547429|NCT02655237|144624156|OTHER|The mean differences in the change from baseline between relugolix 40 mg and leuprorelin groups and the two-sided 95% confidence intervals were calculated for each visit.|Mean Difference (Each Visit)|-0.49|||||TWO_SIDED|95.0|-0.787|-0.199|||||Relugolix 40 mg-Leuprorelin|Follow up (up to Week 28)||-0.199|-0.787|
72547430|NCT02655237|144624157|OTHER|Two-sided 95% confidence interval of the difference was calculated between relugolix 40 mg and leuprorelin group.|Mean Difference (Each Visit)|0.07|||||TWO_SIDED|95.0|-0.032|0.174|||||Relugolix 40 mg-Leuprorelin|Week 6 to 12||0.174|-0.032|
72547431|NCT02655237|144624157|OTHER|Two-sided 95% confidence interval of the difference was calculated between relugolix 40 mg and leuprorelin group.|Mean Difference (Each Visit)|0.05|||||TWO_SIDED|95.0|-0.089|0.197|||||Relugolix 40 mg-Leuprorelin|Week 2 to 6||0.197|-0.089|
72547432|NCT02655237|144624157|OTHER|Two-sided 95% confidence interval of the difference was calculated between relugolix 40 mg and leuprorelin group.|Mean Difference (Each Visit)|0.01|||||TWO_SIDED|95.0|-0.06|0.086|||||Relugolix 40 mg-Leuprorelin|Week 18 to 24||0.086|-0.060|
72581177|NCT01526057|144691808|SUPERIORITY||Risk Ratio (RR)|1.05|||||TWO_SIDED|95.0|0.66|1.69|||||Rituximab-EU is the numerator.|Statistical analysis of rituximab-EU versus rituximab-Pfizer at Week 21.||1.69|0.66|
72581178|NCT01526057|144691808|SUPERIORITY||Risk Ratio (RR)|1.19|||||TWO_SIDED|95.0|0.7|2.0|||||Rituximab-EU is the numerator.|Statistical analysis of rituximab-EU versus rituximab-Pfizer at Week 25 (EOT).||2.00|0.70|
72581179|NCT01526057|144691808|SUPERIORITY||Risk Ratio (RR)|0.7|||||TWO_SIDED|95.0|0.28|1.73|||||Rituximab-US is the numerator.|Statistical analysis of rituximab-US versus rituximab-Pfizer at Week 3.||1.73|0.28|
72547433|NCT02655237|144624157|OTHER|Two-sided 95% confidence interval of the difference was calculated between relugolix 40 mg and leuprorelin group.|Mean Difference (Each Visit)|0.02|||||TWO_SIDED|95.0|-0.063|0.099|||||Relugolix 40 mg-Leuprorelin|For 6 Weeks Before the Final Dose (up to Week 24)||0.099|-0.063|
72547434|NCT02655237|144624158|OTHER|The mean differences in the observed values between relugolix 40 mg and leuprorelin group and the two-sided 95% confidence intervals were calculated for each visit.|Mean Difference (Each Visit)|-2.5|||||TWO_SIDED|95.0|-6.39|1.43|||||Relugolix 40 mg-Leuprorelin|Week 4||1.43|-6.39|
72547435|NCT02655237|144624158|OTHER|The mean differences in the observed values between relugolix 40 mg and leuprorelin group and the two-sided 95% confidence intervals were calculated for each visit.|Mean Difference (Each Visit)|-4.0|||||TWO_SIDED|95.0|-6.68|-1.31|||||Relugolix 40 mg-Leuprorelin|Week 8||-1.31|-6.68|
72547436|NCT02655237|144624158|OTHER|The mean differences in the observed values between relugolix 40 mg and leuprorelin group and the two-sided 95% confidence intervals were calculated for each visit.|Mean Difference (Each Visit)|0.2|||||TWO_SIDED|95.0|-1.99|2.36|||||Relugolix 40 mg-Leuprorelin|Week 12||2.36|-1.99|
72547437|NCT02655237|144624158|OTHER|The mean differences in the observed values between relugolix 40 mg and leuprorelin group and the two-sided 95% confidence intervals were calculated for each visit.|Mean Difference (Each Visit)|1.3|||||TWO_SIDED|95.0|-0.68|3.28|||||Relugolix 40 mg-Leuprorelin|Week 16||3.28|-0.68|
72547438|NCT02655237|144624158|OTHER|The mean differences in the observed values between relugolix 40 mg and leuprorelin group and the two-sided 95% confidence intervals were calculated for each visit.|Mean Difference (Each Visit)|0.3|||||TWO_SIDED|95.0|-1.8|2.32|||||Relugolix 40 mg-Leuprorelin|Week 20||2.32|-1.80|
72547439|NCT02655237|144624158|OTHER|The mean differences in the observed values between relugolix 40 mg and leuprorelin group and the two-sided 95% confidence intervals were calculated for each visit.|Mean Difference (Each Visit)|0.5|||||TWO_SIDED|95.0|-1.48|2.52|||||Relugolix 40 mg-Leuprorelin|Week 24||2.52|-1.48|
72547440|NCT02655237|144624158|OTHER|The mean differences in the observed values between relugolix 40 mg and leuprorelin group and the two-sided 95% confidence intervals were calculated for each visit.|Mean Difference (Each Visit)|3.4|||||TWO_SIDED|95.0|1.08|5.77|||||Relugolix 40 mg-Leuprorelin|Follow-Up (up to Week 28)||5.77|1.08|
72547441|NCT02655237|144624159|OTHER|The mean differences in the observed values between relugolix 40 mg and leuprorelin group and the two-sided 95% confidence intervals were calculated for each visit.|Mean Difference (Each Visit)|2.3|||||TWO_SIDED|95.0|-1.66|6.34|||||Relugolix 40 mg-Leuprorelin|Week 4||6.34|-1.66|
72581180|NCT01526057|144691808|SUPERIORITY||Risk Ratio (RR)|0.81|||||TWO_SIDED|95.0|0.43|1.54|||||Rituximab-US is the numerator.|Statistical analysis of rituximab-US versus rituximab-Pfizer at Week 5.||1.54|0.43|
72581181|NCT01526057|144691808|SUPERIORITY||Risk Ratio (RR)|0.83|||||TWO_SIDED|95.0|0.49|1.42|||||Rituximab-US is the numerator.|Statistical analysis of rituximab-US versus rituximab-Pfizer at Week 9.||1.42|0.49|
72581182|NCT01526057|144691808|SUPERIORITY||Risk Ratio (RR)|0.79|||||TWO_SIDED|95.0|0.5|1.22|||||Rituximab-US is the numerator.|Statistical analysis of rituximab-US versus rituximab-Pfizer at Week 13.||1.22|0.50|
72581183|NCT01526057|144691808|SUPERIORITY||Risk Ratio (RR)|0.9|||||TWO_SIDED|95.0|0.57|1.44|||||Rituximab-US is the numerator.|Statistical analysis of rituximab-US versus rituximab-Pfizer at Week 17.||1.44|0.57|
72547442|NCT02655237|144624159|OTHER|The mean differences in the observed values between relugolix 40 mg and leuprorelin group and the two-sided 95% confidence intervals were calculated for each visit.|Mean Difference (Each Visit)|2.7|||||TWO_SIDED|95.0|-0.37|5.77|||||Relugolix 40 mg-Leuprorelin|Week 8||5.77|-0.37|
72547443|NCT02655237|144624159|OTHER|The mean differences in the observed values between relugolix 40 mg and leuprorelin group and the two-sided 95% confidence intervals were calculated for each visit.|Mean Difference (Each Visit)|0.9|||||TWO_SIDED|95.0|-1.84|3.61|||||Relugolix 40 mg-Leuprorelin|Week 12||3.61|-1.84|
72547444|NCT02655237|144624159|OTHER|The mean differences in the observed values between relugolix 40 mg and leuprorelin group and the two-sided 95% confidence intervals were calculated for each visit.|Mean Difference (Each Visit)|0.1|||||TWO_SIDED|95.0|-2.61|2.79|||||Relugolix 40 mg-Leuprorelin|Week 16||2.79|-2.61|
72412151|NCT01248884|144332321|NON_INFERIORITY|Non-inferiority in terms of immune response to hepatitis B (HBs) antigens was demonstrated if the upper limit of the 97.5 confidence interval (CI) on the group difference (Infanrix hexa minus GSK217744 Group 2) in the percentage of seroprotected subjects was below or equal to 10%.|Difference in percentage|-0.92|||||TWO_SIDED|97.5|-5.07|3.02||||||Immune response non-inferiority - anti-HBs (CLIA)||3.02|-5.07|
72547445|NCT02655237|144624159|OTHER|The mean differences in the observed values between relugolix 40 mg and leuprorelin group and the two-sided 95% confidence intervals were calculated for each visit.|Mean Difference (Each Visit)|0.8|||||TWO_SIDED|95.0|-1.74|3.41|||||Relugolix 40 mg-Leuprorelin|Week 20||3.41|-1.74|
72547446|NCT02655237|144624159|OTHER|The mean differences in the observed values between relugolix 40 mg and leuprorelin group and the two-sided 95% confidence intervals were calculated for each visit.|Mean Difference (Each Visit)|0.3|||||TWO_SIDED|95.0|-2.07|2.71|||||Relugolix 40 mg-Leuprorelin|Week 24||2.71|-2.07|
72547447|NCT02655237|144624159|OTHER|The mean differences in the observed values between relugolix 40 mg and leuprorelin group and the two-sided 95% confidence intervals were calculated for each visit.|Mean Difference (Each Visit)|-1.4|||||TWO_SIDED|95.0|-3.96|1.09|||||Relugolix 40 mg-Leuprorelin|Follow-Up (up to Week 28)||1.09|-3.96|
72547448|NCT03679741|144624169|NON_INFERIORITY|A non-inferiority margin of -5 points was used. This margin is based on a 10% shift in the distribution of CLUE scores.|Mean Difference (Final Values)|1.9|STANDARD_DEVIATION|1.99|||TWO_SIDED|95.0|-1.9|5.8|||Bayesian multivariate normal random-effe|A 95% Credible Interval for the Posterior mean difference between the Test and Control was used to test for non-inferiority.|Mean difference was calculated as test minus control|It was calculated that 30 participants randomized in a 1:1 fashion between the two lens wear sequences would have at least 80% power to detect a 5 point difference between the test and control lenses with respect to overall comfort at the 2-week follow-up. Sample size was determined using Stroup's Method (alpha=0.05).||5.8|-1.9|
72547449|NCT03679741|144624170|NON_INFERIORITY|A cumulative odds ratio non-inferiority margin of 0.67 was used. This margin is based on no more than a 10% difference in proportion between the Test and the Control lenses. The odds ratio represents the cumulative odds ratio of having a higher rating/experience of the Test lens compared to the Control lens.|Odds Ratio (OR)|3.97|STANDARD_DEVIATION|1.138|||TWO_SIDED|95.0|2.27|6.62|||Bayesian multinomial random-effects mode|A 95% Credible Interval for the odds ratio, was used to test for non-inferiority.|Odds ratio was calculated as test over control|||6.62|2.27|
72547450|NCT03679741|144624171|NON_INFERIORITY|A non-inferiority margin of 0.05 logMAR was used. This margin corresponds to a half line difference. Non-inferiority was declared if the upper bound of the 95% credible interval was below 0.05 logMAR.|Mean Difference (Final Values)|-0.022|STANDARD_DEVIATION|0.0074|||TWO_SIDED|95.0|-0.037|-0.008|||Bayesian multivariate normal model|with random effects|Mean difference was calculated as Test minus Control|It was calculated that 4 participants randomized in a 1:1 fashion between the two lens types would have at least 80% power to detect non-inferiority with respect to visual acuity (logMAR) at the 2-week follow-up. Sample size was determined using Stroup's method. The analysis presented below, summarizes the low luminance high contrast lighting condition.||-0.008|-0.037|
72581184|NCT01526057|144691808|SUPERIORITY||Risk Ratio (RR)|1.36|||||TWO_SIDED|95.0|0.88|2.1|||||Rituximab-US is the numerator.|Statistical analysis of rituximab-US versus rituximab-Pfizer at Week 21.||2.10|0.88|
72581185|NCT01526057|144691808|SUPERIORITY||Risk Ratio (RR)|1.31|||||TWO_SIDED|95.0|0.78|2.18|||||Rituximab-US is the numerator.|Statistical analysis of rituximab-US versus rituximab-Pfizer at Week 25 (EOT).||2.18|0.78|
72547451|NCT03679741|144624171|NON_INFERIORITY|A non-inferiority margin of 0.05 logMAR was used. This margin corresponds to a half line difference. Non-inferiority was declared if the upper bound of the 95% credible interval was below 0.05 logMAR.|Mean Difference (Final Values)|-0.034|STANDARD_DEVIATION|0.0075|||TWO_SIDED|95.0|-0.049|-0.02|||Bayesian multivariate normal model|with random effect|Mean difference was calculated as Test minus Control|It was calculated that 4 participants randomized in a 1:1 fashion between the two lens types would have at least 80% power to detect non-inferiority with respect to visual acuity (logMAR) at the 2-week follow-up. Sample size was determined using Stroup's method. The analysis presented below, summarizes the high illumination low contrast lighting condition.||-0.020|-0.049|
72547452|NCT03679741|144624172|SUPERIORITY|A superiority margin of 90% was used. Superiority was concluded if the lower limit of the 95% credible interval was above 90%|Mean Percentage of eyes|100.0|STANDARD_DEVIATION|0.002|||TWO_SIDED|95.0|99.0|100.0|||Bayesian beta- binomial model|for correlated binary data||It was calculated that 65 participants were required to show that the acceptable lens fitting for the Test lens would be superior to 90% with at least 80% power. Sample size was determined using simulations methods for repeated measures.||100.0|99.0|
72581186|NCT01526057|144691808|SUPERIORITY||Risk Ratio (RR)|0.94|||||TWO_SIDED|95.0|0.36|2.45|||||Rituximab-US is the numerator.|Statistical analysis of rituximab-US versus rituximab-EU at Week 3.||2.45|0.36|
72581187|NCT01526057|144691808|SUPERIORITY||Risk Ratio (RR)|0.77|||||TWO_SIDED|95.0|0.41|1.44|||||Rituximab-US is the numerator.|Statistical analysis of rituximab-US versus rituximab-EU at Week 5.||1.44|0.41|
72581188|NCT01526057|144691808|SUPERIORITY||Risk Ratio (RR)|0.78|||||TWO_SIDED|95.0|0.47|1.31|||||Rituximab-US is the numerator.|Statistical analysis of rituximab-US versus rituximab-EU at Week 9.||1.31|0.47|
72581189|NCT01526057|144691808|SUPERIORITY||Risk Ratio (RR)|0.74|||||TWO_SIDED|95.0|0.48|1.13|||||Rituximab-US is the numerator.|Statistical analysis of rituximab-US versus rituximab-EU at Week 13.||1.13|0.48|
72581190|NCT01526057|144691808|SUPERIORITY||Risk Ratio (RR)|0.86|||||TWO_SIDED|95.0|0.55|1.36|||||Rituximab-US is the numerator.|Statistical analysis of rituximab-US versus rituximab-EU at Week 17.||1.36|0.55|
72412152|NCT02334800|144332348|SUPERIORITY_OR_OTHER||ratio of adjusted geometric mean|73.6|||||TWO_SIDED|90.0|57.81|93.71||||||||93.71|57.81|
72412153|NCT02334800|144332348|SUPERIORITY_OR_OTHER||ratio of adjusted geometric mean|115.3|||||TWO_SIDED|90.0|90.57|146.79||||||||146.79|90.57|
72581191|NCT01526057|144691808|SUPERIORITY||Risk Ratio (RR)|1.29|||||TWO_SIDED|95.0|0.85|1.95|||||Rituximab-US is the numerator.|Statistical analysis of rituximab-US versus rituximab-EU at Week 21.||1.95|0.85|
72581192|NCT01526057|144691808|SUPERIORITY||Risk Ratio (RR)|1.1|||||TWO_SIDED|95.0|0.7|1.73|||||Rituximab-US is the numerator.|Statistical analysis of rituximab-US versus rituximab-EU at Week 25 (EOT).||1.73|0.70|
72581193|NCT01526057|144691809|SUPERIORITY||Risk Ratio (RR)|0.47|||||TWO_SIDED|95.0|0.12|1.79|||||Rituximab-EU is the numerator.|Statistical analysis of rituximab-EU versus rituximab-Pfizer at Week 3.||1.79|0.12|
72581194|NCT01526057|144691809|SUPERIORITY||Risk Ratio (RR)|0.5|||||TWO_SIDED|95.0|0.2|1.26|||||Rituximab-EU is the numerator.|Statistical analysis of rituximab-EU versus rituximab-Pfizer at Week 5.||1.26|0.20|
72412154|NCT02334800|144332348|SUPERIORITY_OR_OTHER||ratio of adjusted geometric mean|133.68|||||TWO_SIDED|90.0|105.0|170.19||||||||170.19|105.00|
72581195|NCT01526057|144691809|SUPERIORITY||Risk Ratio (RR)|0.78|||||TWO_SIDED|95.0|0.43|1.41|||||Rituximab-EU is the numerator.|Statistical analysis of rituximab-EU versus rituximab-Pfizer at Week 9.||1.41|0.43|
72581196|NCT01526057|144691809|SUPERIORITY||Risk Ratio (RR)|1.03|||||TWO_SIDED|95.0|0.61|1.74|||||Rituximab-EU is the numerator.|Statistical analysis of rituximab-EU versus rituximab-Pfizer at Week 13.||1.74|0.61|
72581197|NCT01526057|144691809|SUPERIORITY||Risk Ratio (RR)|0.98|||||TWO_SIDED|95.0|0.56|1.74|||||Rituximab-EU is the numerator.|Statistical analysis of rituximab-EU versus rituximab-Pfizer at Week 17.||1.74|0.56|
72581198|NCT01526057|144691809|SUPERIORITY||Risk Ratio (RR)|0.68|||||TWO_SIDED|95.0|0.34|1.36|||||Rituximab-EU is the numerator.|Statistical analysis of rituximab-EU versus rituximab-Pfizer at Week 21.||1.36|0.34|
72581199|NCT01526057|144691809|SUPERIORITY||Risk Ratio (RR)|0.86|||||TWO_SIDED|95.0|0.46|1.63|||||Rituximab-EU is the numerator.|Statistical analysis of rituximab-EU versus rituximab-Pfizer at Week 25 (EOT).||1.63|0.46|
72581200|NCT01526057|144691809|SUPERIORITY||Risk Ratio (RR)|0.83|||||TWO_SIDED|95.0|0.27|2.6|||||Rituximab-US is the numerator.|Statistical analysis of rituximab-US versus rituximab-Pfizer at Week 3.||2.60|0.27|
72581201|NCT01526057|144691809|SUPERIORITY||Risk Ratio (RR)|0.71|||||TWO_SIDED|95.0|0.31|1.62|||||Rituximab-US is the numerator.|Statistical analysis of rituximab-US versus rituximab-Pfizer at Week 5.||1.62|0.31|
72581202|NCT01526057|144691809|SUPERIORITY||Risk Ratio (RR)|0.76|||||TWO_SIDED|95.0|0.41|1.4|||||Rituximab-US is the numerator.|Statistical analysis of rituximab-US versus rituximab-Pfizer at Week 9.||1.40|0.41|
72581203|NCT01526057|144691809|SUPERIORITY||Risk Ratio (RR)|0.89|||||TWO_SIDED|95.0|0.51|1.57|||||Rituximab-US is the numerator.|Statistical analysis of rituximab-US versus rituximab-Pfizer at Week 13.||1.57|0.51|
72581204|NCT01526057|144691809|SUPERIORITY||Risk Ratio (RR)|0.93|||||TWO_SIDED|95.0|0.51|1.68|||||Rituximab-US is the numerator.|Statistical analysis of rituximab-US versus rituximab-Pfizer at Week 17.||1.68|0.51|
72581205|NCT01526057|144691809|SUPERIORITY||Risk Ratio (RR)|1.22|||||TWO_SIDED|95.0|0.68|2.19|||||Rituximab-US is the numerator.|Statistical analysis of rituximab-US versus rituximab-Pfizer at Week 21.||2.19|0.68|
72581206|NCT01526057|144691809|SUPERIORITY||Risk Ratio (RR)|0.84|||||TWO_SIDED|95.0|0.44|1.62|||||Rituximab-US is the numerator.|Statistical analysis of rituximab-US versus rituximab-Pfizer at Week 25 (EOT).||1.62|0.44|
72581207|NCT01526057|144691809|SUPERIORITY||Risk Ratio (RR)|1.79|||||TWO_SIDED|95.0|0.44|7.2|||||Rituximab-US is the numerator.|Statistical analysis of rituximab-US versus rituximab-EU at Week 3.||7.20|0.44|
72581208|NCT01526057|144691809|SUPERIORITY||Risk Ratio (RR)|1.41|||||TWO_SIDED|95.0|0.52|3.86|||||Rituximab-US is the numerator.|Statistical analysis of rituximab-US versus rituximab-EU at Week 5.||3.86|0.52|
72581209|NCT01526057|144691809|SUPERIORITY||Risk Ratio (RR)|0.97|||||TWO_SIDED|95.0|0.51|1.87|||||Rituximab-US is the numerator.|Statistical analysis of rituximab-US versus rituximab-EU at Week 9.||1.87|0.51|
72581210|NCT01526057|144691809|SUPERIORITY||Risk Ratio (RR)|0.87|||||TWO_SIDED|95.0|0.5|1.5|||||Rituximab-US is the numerator.|Statistical analysis of rituximab-US versus rituximab-EU at Week 13.||1.50|0.50|
72581211|NCT01526057|144691809|SUPERIORITY||Risk Ratio (RR)|0.94|||||TWO_SIDED|95.0|0.52|1.69|||||Rituximab-US is the numerator.|Statistical analysis of rituximab-US versus rituximab-EU at Week 17.||1.69|0.52|
72581212|NCT01526057|144691809|SUPERIORITY||Risk Ratio (RR)|1.8|||||TWO_SIDED|95.0|0.93|3.5|||||Rituximab-US is the numerator.|Statistical analysis of rituximab-US versus rituximab-EU at Week 21.||3.50|0.93|
72581213|NCT01526057|144691809|SUPERIORITY||Risk Ratio (RR)|0.98|||||TWO_SIDED|95.0|0.51|1.89|||||Rituximab-US is the numerator.|Statistical analysis of rituximab-US versus rituximab-EU at Week 25 (EOT).||1.89|0.51|
72412155|NCT02334800|144332349|SUPERIORITY_OR_OTHER||ratio of adjusted geometric mean|94.99|||||TWO_SIDED|90.0|69.93|129.03||||||||129.03|69.93|
72581214|NCT02189837|144691818|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|88.76|STANDARD_ERROR_OF_MEAN|36.67||0.018|TWO_SIDED|95.0|15.73|161.8|||ANCOVA|Model includes terms for the 2 factors in the factorial design (placebo or evolocumab and oral placebo or statin), their interaction, and LDL-C level.||The superiority of evolocumab monotherapy to placebo was tested using a 2-sided p-value at a significance level of 0.05.||161.80|15.73|0.018
72581215|NCT02189837|144691818|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|236.35|STANDARD_ERROR_OF_MEAN|36.32|<|0.001|TWO_SIDED|95.0|164.02|308.69|||ANCOVA|Model includes terms for the 2 factors in the factorial design (placebo or evolocumab and oral placebo or statin), their interaction, and LDL-C level.||The treatment effect of evolocumab plus atorvastatin compared with placebo plus atorvastatin was estimated and a nominal p-value is provided.||308.69|164.02|<0.001
72581216|NCT02189837|144691818|SUPERIORITY_OR_OTHER||Treatment Effect|147.59|STANDARD_ERROR_OF_MEAN|51.61||0.005|TWO_SIDED|95.0|44.8|250.38|||ANCOVA|Model includes terms for the 2 factors in the factorial design (placebo or evolocumab and oral placebo or statin), their interaction, and LDL-C level.||To assess whether the treatment effect of evolocumab compared with placebo depended on being administered alone or combined with atorvastatin, the interaction was tested, i.e., the difference between the treatment difference versus the respective placebo group for the evolocumab+atorvastatin group and the evolocumab group was calculated.||250.38|44.80|0.005
72581217|NCT02189837|144691819|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-57.14|STANDARD_ERROR_OF_MEAN|4.4|<|0.001||95.0|-65.91|-48.38|||ANCOVA|Model includes terms for the 2 factors in the factorial design (placebo or evolocumab and oral placebo or statin), their interaction, and LDL-C level.||||-48.38|-65.91|<0.001
72581218|NCT02189837|144691819|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-37.95|STANDARD_ERROR_OF_MEAN|4.31|<|0.001|TWO_SIDED|95.0|-46.55|-29.34|||ANCOVA|Model includes terms for the 2 factors in the factorial design (placebo or evolocumab and oral placebo or statin), their interaction, and LDL-C level.||||-29.34|-46.55|<0.001
72581219|NCT02189837|144691819|SUPERIORITY_OR_OTHER||Treatment Effect|19.2|STANDARD_ERROR_OF_MEAN|6.15||0.003|TWO_SIDED|95.0|6.93|31.47|||ANCOVA|Model includes terms for the 2 factors in the factorial design (placebo or evolocumab and oral placebo or statin), their interaction, and LDL-C level.||||31.47|6.93|0.003
72581220|NCT02189837|144691820|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-16.65|STANDARD_ERROR_OF_MEAN|10.41||0.11|TWO_SIDED|95.0|-37.37|4.08|||ANCOVA|Model includes terms for the 2 factors in the factorial design (placebo or evolocumab and oral placebo or statin), their interaction, and LDL-C level.||||4.08|-37.37|0.11
72581221|NCT02189837|144691820|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-32.66|STANDARD_ERROR_OF_MEAN|10.31||0.002|TWO_SIDED|95.0|-53.19|-12.13|||ANCOVA|Model includes terms for the 2 factors in the factorial design (placebo or evolocumab and oral placebo or statin), their interaction, and LDL-C level.||||-12.13|-53.19|0.002
72581222|NCT02189837|144691820|SUPERIORITY_OR_OTHER||Treatment Effect|-16.01|STANDARD_ERROR_OF_MEAN|14.65||0.28|TWO_SIDED|95.0|-45.18|13.16|||ANCOVA|Model includes terms for the 2 factors in the factorial design (placebo or evolocumab and oral placebo or statin), their interaction, and LDL-C level.||||13.16|-45.18|0.28
72581223|NCT02189837|144691821|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-2.12|STANDARD_ERROR_OF_MEAN|13.4||0.87|TWO_SIDED|95.0|-28.94|24.7|||ANCOVA|Model includes terms for the 2 factors in the factorial design (placebo or evolocumab and oral placebo or statin), their interaction, and LDL-C level.||The superiority of evolocumab monotherapy to placebo was tested using a 2-sided p-value at a significance level of 0.05.||24.70|-28.94|0.87
72581224|NCT02189837|144691821|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|39.06|STANDARD_ERROR_OF_MEAN|12.76||0.003|TWO_SIDED|95.0|13.52|64.59|||ANCOVA|Model includes terms for the 2 factors in the factorial design (placebo or evolocumab and oral placebo or statin), their interaction, and LDL-C level.||The treatment effect of evolocumab plus atorvastatin compared with placebo plus atorvastatin was estimated and a nominal p-value is provided.||64.59|13.52|0.003
72412156|NCT02334800|144332349|SUPERIORITY_OR_OTHER||ratio of adjusted geometric mean|117.75|||||TWO_SIDED|90.0|86.69|159.95||||||||159.95|86.69|
72581225|NCT02189837|144691821|SUPERIORITY_OR_OTHER||Treatment Effect|41.18|STANDARD_ERROR_OF_MEAN|18.5||0.03|TWO_SIDED|95.0|4.15|78.2|||ANCOVA|Model includes terms for the 2 factors in the factorial design (placebo or evolocumab and oral placebo or statin), their interaction, and LDL-C level.||To assess whether the treatment effect of evolocumab compared with placebo depended on being administered alone or combined with atorvastatin, the interaction was tested, i.e., the difference between the treatment difference versus the respective placebo group for the evolocumab+atorvastatin group and the evolocumab group was calculated.||78.20|4.15|0.030
72581226|NCT02189837|144691822|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-39.43|STANDARD_ERROR_OF_MEAN|11.6||0.001|TWO_SIDED|95.0|-62.66|-16.21|||ANCOVA|Model includes terms for the 2 factors in the factorial design (placebo or evolocumab and oral placebo or statin), their interaction, and LDL-C level.||||-16.21|-62.66|0.001
72581227|NCT02189837|144691822|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|23.28|STANDARD_ERROR_OF_MEAN|11.05||0.039|TWO_SIDED|95.0|1.16|45.4|||ANCOVA|Model includes terms for the 2 factors in the factorial design (placebo or evolocumab and oral placebo or statin), their interaction, and LDL-C level.||||45.40|1.16|0.039
72581228|NCT02189837|144691822|SUPERIORITY_OR_OTHER||Treatment Effect|62.72|STANDARD_ERROR_OF_MEAN|16.02|<|0.001|TWO_SIDED|95.0|30.65|94.79|||ANCOVA|Model includes terms for the 2 factors in the factorial design (placebo or evolocumab and oral placebo or statin), their interaction, and LDL-C level.||||94.79|30.65|<0.001
72581229|NCT02443740|144691848|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Geometric Mean Ratio.|39.58|||||TWO_SIDED|90.0|30.14|51.99|||||Values have been back-transformed from the log scale.|||51.99|30.14|
72581230|NCT02443740|144691849|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Geometric Mean Ratio|80.6|||||TWO_SIDED|90.0|59.74|108.75|||||Values have been back-transformed from the log scale.|||108.75|59.74|
72581231|NCT02443740|144691850|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Geometric Mean Ratio|80.12|||||TWO_SIDED|90.0|58.92|108.94|||||Values have been back-transformed from the log scale.|||108.94|58.92|
72581232|NCT02443740|144691855|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Geometric Mean Ratio|65.58|||||TWO_SIDED|90.0|62.18|69.16|||||Values have been back-transformed from the log scale.|||69.16|62.18|
72581233|NCT02443740|144691856|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Geometric Mean Ratio|68.62|||||TWO_SIDED|90.0|63.27|74.41|||||Values have been back-transformed from the log scale.|||74.41|63.27|
72581234|NCT02443740|144691857|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Geometric Mean Ratio.|29.76|||||TWO_SIDED|90.0|24.17|36.64|||||Values have been back-transformed from the log scale.|||36.64|24.17|
72412157|NCT02334800|144332349|SUPERIORITY_OR_OTHER||ratio of adjusted geometric mean|129.89|||||TWO_SIDED|90.0|95.63|176.43||||||||176.43|95.63|
72581235|NCT02443740|144691859|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Geometric Mean Ratio|16.71|||||TWO_SIDED|90.0|15.35|18.18|||||Values were back-transformed from the log scale.|||18.18|15.35|
72581236|NCT02443740|144691861|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Geometric Mean Ratio|15.21|||||TWO_SIDED|90.0|13.29|17.42|||||Values were back-transformed from the log scale.|||17.42|13.29|
72581237|NCT01074944|144691874|NON_INFERIORITY_OR_EQUIVALENCE|Eliglustat QD treatment was declared non-inferior to BID treatment if the lower bound of the 95% confidence interval (CI) for the difference was within the non-inferiority margin of -0.15 (or -15%).|Difference in Percentage Stable|-2.7|||||TWO_SIDED|95.0|-17.7|11.9||||||||11.9|-17.7|
72581238|NCT02348112|144691910|NON_INFERIORITY|The number and proportion of subjects experiencing a 50% or greater reduction in pad weight at 6 months were compared, and non-inferiority assessed using a normal approximation test (Z-test) for a difference in binomial proportion. Non-inferiority was considered achieved if the 95% confidence interval for the difference in proportions (Comparator - Altis) was less than 0.15.|Difference in Proportions|-0.054||||0.013|TWO_SIDED|95.0|-0.139|0.031|||Normal approximation test (Z-test)|||||0.031|-0.139|0.013
72581239|NCT02348112|144691911|NON_INFERIORITY|The number and proportion of subjects experiencing device- and/or procedure-related serious adverse events were tabulated for each study group. Non-inferiority through 36 months was calculated using a normal approximation test (Z-test) for a difference in binomial proportion. Non-inferiority was considered achieved if the lower limit of the 95% confidence interval for the difference in proportions (Comparator - Altis) is greater than -0.10 in the mITT analysis population.|Difference in Proportions|0.013|||<|0.0001|TWO_SIDED|95.0|-0.023|0.048|||Normal approximation test (Z-test)|||||0.048|-0.023|<0.0001
72581240|NCT03741400|144691917|OTHER|||||||0.88||||||A priori threshold for statistical significance, 0.05|ANCOVA|Nonparametric ANCOVA using Quade's test with adjustments for age, sex, and NIHSS||Analysis of change in total seconds||||0.88
72581241|NCT03741400|144691917|OTHER|||||||0.99||||||A priori threshold for statistical significance, 0.05|ANCOVA|Nonparametric ANCOVA using Quade's test with adjustments for age, sex, and NIHSS||Analysis of change in fine motor skill assessment||||0.99
72581242|NCT03741400|144691917|OTHER|||||||0.8||||||A priori threshold for statistical significance, 0.05|ANCOVA|Nonparametric ANCOVA using Quade's test with adjustments for age, sex, and NIHSS||Analysis of change in gross motor skills assessment||||0.80
72581243|NCT03741400|144691918|OTHER|||||||0.61||||||A priori threshold for statistical significance, 0.05|ANCOVA|Nonparametric ANCOVA using Quade's test with adjustments for age, sex, and NIHSS||||||0.61
72581244|NCT03741400|144691919|OTHER|||||||0.47||||||A priori threshold for statistical significance, 0.05|ANCOVA|Nonparametric ANCOVA using Quade's test with adjustments for age, sex, and NIHSS||Analysis of change in total seconds||||0.47
72581245|NCT03741400|144691919|OTHER|||||||0.55||||||A priori threshold for statistical significance, 0.05|ANCOVA|Nonparametric ANCOVA using Quade's test with adjustments for age, sex, and NIHSS||Analysis of change in fine motor skill assessment||||0.55
72581246|NCT03741400|144691919|OTHER|||||||0.38||||||A priori threshold for statistical significance, 0.05|ANCOVA|Nonparametric ANCOVA using Quade's test with adjustments for age, sex, and NIHSS||Analysis of change in gross motor skills assessment||||0.38
72581247|NCT03741400|144691920|OTHER|||||||0.24||||||A priori threshold for statistical significance, 0.05|ANCOVA|Nonparametric ANCOVA using Quade's test with adjustments for age, sex, and NIHSS||||||0.24
72581248|NCT03741400|144691921|OTHER|||||||0.18||||||A priori threshold for statistical significance, 0.05|Mann-Whitney U test|||||||0.18
72581249|NCT03741400|144691922|OTHER|||||||0.926||||||A priori threshold for statistical significance, 0.05|ANCOVA|Nonparametric ANCOVA using Quade's test with adjustments for age, sex, and NIHSS||Analysis at week 12||||0.926
72412158|NCT02334800|144332350|SUPERIORITY_OR_OTHER||ratio of adjusted geometric mean|83.01|||||TWO_SIDED|90.0|65.37|105.43||||||||105.43|65.37|
72547453|NCT03679741|144624173|NON_INFERIORITY|A non-inferiority cumulative odds ratio margin of 2 was used. This margin corresponds to no more than a 5% difference between the Test and Control lenses assuming the Control reference rate does not exceed 5%. Non-inferiority was declared if the upper bound of the 95% credible interval was below 2.|Mean Difference (Final Values)|0.001|STANDARD_DEVIATION|0.003|||TWO_SIDED|95.0|-0.004|0.008|||Bayesian beta-binomial hierarchical||Mean difference was calculated as Test minus Control.|It was calculated that 50 participants randomized in a 1:1 fashion between the two lens wear sequences would have at least 80% power to detect 5% difference between the Test and Control lens with respect to the proportion of eyes with Grade 3 or higher slit lamp findings across all study visits. Sample size was determined using simulations methods.||0.008|-0.004|
72547454|NCT03679741|144624174|NON_INFERIORITY|A non-inferiority margin of -5 points was used. This margin is based on a 10% shift in the distribution of CLUE scores.|Mean Difference (Final Values)|5.6|STANDARD_DEVIATION|1.29|||TWO_SIDED|95.0|3.1|8.1|||Bayesian multivariate normal model|for random effects|Mean difference was calculated as test minus control|Sample size was based on primary endpoints only.||8.1|3.1|
72581250|NCT03741400|144691922|OTHER|||||||0.828||||||A priori threshold for statistical significance, 0.05|ANCOVA|Nonparametric ANCOVA using Quade's test with adjustments for age, sex, and NIHSS||Analysis at week 24||||0.828
72581251|NCT03714828|144691923|OTHER||Overall Response Rate|100.0||||0.0005|ONE_SIDED|95.0|76.2||||One-sample binomial test|One-sample binomial test versus null hypothesis value of 0.50.|||||76.2|0.0005
72581252|NCT03714828|144691925|OTHER|Descriptive statistics|Mean|48.7|STANDARD_DEVIATION|29.2|||TWO_SIDED|||||||||||||
72581253|NCT03714828|144691927|OTHER|Binomial proportion of TILs|Percentage|83.3|||||TWO_SIDED|||||||||||||
72581254|NCT03714828|144691930|OTHER|Counts of TILs|Percentage|100.0|||||TWO_SIDED|||||||||||||
72581255|NCT03714828|144691931|OTHER||Percentage|100.0|||||TWO_SIDED|||||||||||||
72581256|NCT01263938|144691971|OTHER|||||||0.625||||||Threshold for statistical significance: p\<0.05|Wilcoxon signed rank|||Sample size calculations were based on having sufficient power to detect a change in each of the outcome variables from baseline to week 12.The effect size was calculated as (detectable difference in change in outcome) / (SD of the change). Based on preliminary in vitro data, the smallest effect size was 1.88. Assuming that only 40% of this effect will be present in vivo (effect size=0.75), alpha = 0.05 and 80% power, n=16 is needed to complete the study.||||0.625
72581257|NCT01263938|144691971|OTHER|||||||0.813||||||Threshold for statistical significance: p\<0.05|Wilcoxon signed rank|||Sample size calculations were based on having sufficient power to detect a change in each of the outcome variables from baseline to week 12.The effect size was calculated as (detectable difference in change in outcome) / (SD of the change). Based on preliminary in vitro data, the smallest effect size was 1.88. Assuming that only 40% of this effect will be present in vivo (effect size=0.75), alpha = 0.05 and 80% power, n=16 is needed to complete the study.||||0.813
72581258|NCT01263938|144691971|OTHER||||||>|0.999||||||Threshold for statistical significance: p\<0.05|Wilcoxon signed rank|||Sample size calculations were based on having sufficient power to detect a change in each of the outcome variables from baseline to week 12.The effect size was calculated as (detectable difference in change in outcome) / (SD of the change). Based on preliminary in vitro data, the smallest effect size was 1.88. Assuming that only 40% of this effect will be present in vivo (effect size=0.75), alpha = 0.05 and 80% power, n=16 is needed to complete the study.||||>0.999
72581259|NCT01263938|144691972|OTHER||||||>|0.999||||||Threshold for statistical significance: p\<0.05|Wilcoxon signed rank|||Sample size calculations were based on having sufficient power to detect a change in each of the outcome variables from baseline to week 12.The effect size was calculated as (detectable difference in change in outcome) / (SD of the change). Based on preliminary in vitro data, the smallest effect size was 1.88. Assuming that only 40% of this effect will be present in vivo (effect size=0.75), alpha = 0.05 and 80% power, n=16 is needed to complete the study.||||>0.999
72581260|NCT01263938|144691973|OTHER|||||||0.813||||||Threshold for statistical significance: p\<0.05|Wilcoxon signed rank|||Sample size calculations were based on having sufficient power to detect a change in each of the outcome variables from baseline to week 12.The effect size was calculated as (detectable difference in change in outcome) / (SD of the change). Based on preliminary in vitro data, the smallest effect size was 1.88. Assuming that only 40% of this effect will be present in vivo (effect size=0.75), alpha = 0.05 and 80% power, n=16 is needed to complete the study.||||0.813
72581261|NCT01263938|144691974|OTHER|||||||0.625||||||Threshold for statistical significance: p\<0.05|Wilcoxon signed rank|||Sample size calculations were based on having sufficient power to detect a change in each of the outcome variables from baseline to week 12.The effect size was calculated as (detectable difference in change in outcome) / (SD of the change). Based on preliminary in vitro data, the smallest effect size was 1.88. Assuming that only 40% of this effect will be present in vivo (effect size=0.75), alpha = 0.05 and 80% power, n=16 is needed to complete the study.||||0.625
72581262|NCT02575833|144692033|NON_INFERIORITY|The non-inferiority margin was -90 seconds.|Treatment Difference|-11.0|STANDARD_ERROR_OF_MEAN|20.4|||TWO_SIDED|90.0|-44.9|22.9||||||The primary endpoint was analyzed using an analysis of variance model with terms for treatment group and randomization strata (\< 7 or ≥ 7 minutes). If the lower bound of the 90% confidence interval (CI) of the difference in change from baseline in exercise duration was above the non-inferiority margin of -90 seconds, then the hypothesis that erenumab does not decrease exercise duration would be supported.||22.9|-44.9|
72412159|NCT02334800|144332350|SUPERIORITY_OR_OTHER||ratio of adjusted geometric mean|134.28|||||TWO_SIDED|90.0|105.73|170.53||||||||170.53|105.73|
72581263|NCT02575833|144692034|SUPERIORITY|The log-rank test statistic was used to compare the two treatment groups at a significance level of 0.10.|Normal score|1.55||||0.69|||||||Stratified Log Rank|Log rank test stratified by baseline total exercise time strata (\< 7 minutes or ≥ 7 minutes).|A normal score \< 0 indicates fewer than expected events for erenumab 140 mg relative to placebo and therefore a longer survival time.|||||0.69
72581264|NCT02575833|144692034|SUPERIORITY||Hazard Ratio (HR)|1.11||||0.69|TWO_SIDED|90.0|0.73|1.69|||Cox Proportional Hazard|Adjusted by stratified baseline total exercise time strata (\< 7 or ≥ 7 minutes)|Hazard ratio estimates were obtained from the Cox Proportional Hazard Model. A hazard ratio \< 1.0 indicates a lower average event rate and a longer exercise-induced angina free survival for erenumab 140 mg relative to placebo.|||1.69|0.73|0.69
72581265|NCT02575833|144692034|SUPERIORITY||Hazard Ratio (HR)|0.81||||0.44|TWO_SIDED|90.0|0.52|1.26|||Cox Proportional Hazard|Adjusted by continuous baseline total exercise time|Hazard ratio estimates were obtained from the Cox Proportional Hazard Model. A hazard ratio \< 1.0 indicates a lower average event rate and a longer exercise-induced angina free survival for erenumab 140 mg relative to placebo.|||1.26|0.52|0.44
72581266|NCT02575833|144692034|SUPERIORITY||Hazard Ratio (HR)|0.82||||0.47|TWO_SIDED|90.0|0.52|1.28|||Cox Proportional Hazard|Adjusted by baseline total exercise time strata (\< 7 or ≥ 7 minutes), age group (\< 65, ≥ 65), and sex.|Hazard ratio estimates were obtained from the Cox Proportional Hazard Model. A hazard ratio \< 1.0 indicates a lower average event rate and a longer exercise-induced angina free survival for erenumab 140 mg relative to placebo.|||1.28|0.52|0.47
72581267|NCT02575833|144692035|SUPERIORITY|The log-rank test statistic was used to compare the two treatment groups at a significance level of 0.10.|Normal score|2.2||||0.59|||||||Stratified Log Rank|Log rank test stratified by baseline total exercise time strata (\< 7 minutes or ≥ 7 minutes).|A normal score \< 0 indicates fewer than expected events for erenumab 140 mg relative to placebo and therefore a longer survival time.|||||0.59
72581268|NCT02575833|144692035|SUPERIORITY||Hazard Ratio (HR)|1.14||||0.59|TWO_SIDED|90.0|0.76|1.69|||Cox Proportional Hazard|Adjusted by stratified baseline total exercise time strata (\< 7 or ≥ 7 minutes)|Hazard ratio estimates were obtained from the Cox Proportional Hazard Model. A hazard ratio \< 1.0 indicates a lower average event rate and a longer exercise-induced ST-segment depression free survival for erenumab 140 mg relative to placebo.|||1.69|0.76|0.59
72581269|NCT02575833|144692035|SUPERIORITY||Hazard Ratio (HR)|1.08||||0.75|TWO_SIDED|90.0|0.73|1.6|||Cox Proportional Hazard|Adjusted by continuous baseline total exercise time|Hazard ratio estimates were obtained from the Cox Proportional Hazard Model. A hazard ratio \< 1.0 indicates a lower average event rate and a longer exercise-induced ST-segment depression free survival for erenumab 140 mg relative to placebo.|||1.60|0.73|0.75
72581270|NCT02575833|144692035|SUPERIORITY||Hazard Ratio (HR)|1.24||||0.39|TWO_SIDED|90.0|0.82|1.87|||Cox Proportional Hazard|Adjusted by baseline total exercise time strata (\< 7 or ≥ 7 minutes), age group (\< 65, ≥ 65), and sex.|Hazard ratio estimates were obtained from the Cox Proportional Hazard Model. A hazard ratio \< 1.0 indicates a lower average event rate and a longer exercise-induced ST-segment depression free survival for erenumab 140 mg relative to placebo.|||1.87|0.82|0.39
72581271|NCT03093259|144692036|OTHER|One-sided 10% significance level||||||0.2096|||||||Chi-squared|||||||0.2096
72581272|NCT03093259|144692037|OTHER|||||||0.1588|||||||Chi-squared|||||||0.1588
72581273|NCT03093259|144692038|OTHER|||||||0.483|||||||ANCOVA|||||||0.4830
72581274|NCT03093259|144692039|OTHER|||||||0.0742|||||||ANCOVA|||||||0.0742
72412160|NCT02334800|144332350|SUPERIORITY_OR_OTHER||ratio of adjusted geometric mean|176.88|||||TWO_SIDED|90.0|139.28|224.63||||||||224.63|139.28|
72412161|NCT02334800|144332351|SUPERIORITY_OR_OTHER||ratio of adjusted geometric mean|72.81|||||TWO_SIDED|90.0|56.43|93.93||||||||93.93|56.43|
72581275|NCT03093259|144692040|OTHER|||||||0.0462|||||||ANCOVA|||||||0.0462
72581276|NCT03759392|144692060|SUPERIORITY||Least squares mean difference|-0.447|STANDARD_ERROR_OF_MEAN|0.2931||0.13|TWO_SIDED|95.0|-1.024|0.131|||ANCOVA|Using multiple imputation||||0.131|-1.024|0.13
72581277|NCT03759392|144692061|SUPERIORITY||Least squares mean difference|-5.388|STANDARD_ERROR_OF_MEAN|2.3937||0.025|TWO_SIDED|95.0|-10.108|-0.0668|||ANCOVA|Using multiple imputation||||-0.0668|-10.108|0.025
72581278|NCT03759392|144692062|SUPERIORITY||Least squares mean difference|0.414|STANDARD_ERROR_OF_MEAN|0.6215||0.51|TWO_SIDED|95.0|-0.81|1.639|||ANCOVA|Using multiple imputation||||1.639|-0.810|0.51
72581279|NCT03759392|144692063|SUPERIORITY||Least squares mean difference|0.3|STANDARD_ERROR_OF_MEAN|0.42||0.54|TWO_SIDED|95.0|-0.6|1.1|||Repeated measures mixed model|||||1.1|-0.6|0.54
72581280|NCT01243957|144692064|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Means|1.79|||||TWO_SIDED|90.0|1.61|2.0|||ANOVA|||||2.00|1.61|
72581281|NCT01243957|144692065|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Means|1.63|||||TWO_SIDED|90.0|1.49|1.79|||ANOVA|||||1.79|1.49|
72412162|NCT02334800|144332351|SUPERIORITY_OR_OTHER||ratio of adjusted geometric mean|115.57|||||TWO_SIDED|90.0|89.58|149.11||||||||149.11|89.58|
72412163|NCT02334800|144332351|SUPERIORITY_OR_OTHER||ratio of adjusted geometric mean|134.66|||||TWO_SIDED|90.0|104.38|173.73||||||||173.73|104.38|
72581282|NCT01243957|144692066|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.5459|TWO_SIDED|90.0|-0.5|0.5|||Wilcoxon (Mann-Whitney)|||||0.50|-0.50|0.5459
72581283|NCT01243957|144692067|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Means|1.01|||||TWO_SIDED|90.0|0.99|1.04|||ANOVA|||Ratio of Geometric LS Means of AUCτ for fluoxetine alone and fluoxetine + LY2216684.||1.04|0.99|
72581284|NCT01243957|144692067|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Means|1.04|||||TWO_SIDED|90.0|1.01|1.06|||ANOVA|||Ratio of Geometric LS Means of AUCτ for norfluoxetine alone and norfluoxetine + LY2216684.||1.06|1.01|
72581285|NCT01243957|144692068|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Means|1.0|||||TWO_SIDED|90.0|0.97|1.03|||ANOVA|||Ratio of Geometric LS Means of Cmax for fluoxetine alone and fluoxetine + LY2216684||1.03|0.97|
72581286|NCT01243957|144692068|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Means|1.03|||||TWO_SIDED|90.0|1.0|1.07|||ANOVA|||Ratio of Geometric LS Means of Cmax for norfluoxetine alone and norfluoxetine + LY2216684.||1.07|1.00|
72581287|NCT01243957|144692069|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.08||||0.423|TWO_SIDED|90.0|-3.0|1.42|||Wilcoxon (Mann-Whitney)|||Ratio of Geometric LS Means of Tmax for fluoxetine alone and fluoxetine + LY2216684.||1.42|-3.00|0.4230
72581288|NCT01243957|144692069|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-4.0||||0.0293|TWO_SIDED|90.0|-6.5|-1.0|||Wilcoxon (Mann-Whitney)|||Ratio of Geometric LS Means of Tmax for norfluoxetine alone and norfluoxetine + LY2216684.||-1.00|-6.50|0.0293
72581289|NCT00967330|144692070|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Chi-squared|||||||<0.0001
72581290|NCT00967330|144692071|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.588||||0.0012|TWO_SIDED|95.0|0.423|0.817|||Chi-squared|||||0.817|0.423|0.0012
72581291|NCT00967330|144692072|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.963||||0.8283|TWO_SIDED|95.0|0.684|1.354|||Chi-squared|||||1.354|0.684|0.8283
72581292|NCT00967330|144692074|SUPERIORITY_OR_OTHER||Difference in response rate|0.06||||0.34745|TWO_SIDED|95.0|-0.02|0.14|||Fisher Exact|||Response rate based on participants with CR at 4 weeks after RT.||0.14|-0.02|0.34745
72581293|NCT00967330|144692074|SUPERIORITY_OR_OTHER||Difference in response rate|0.09||||0.17923|TWO_SIDED|95.0|0.0|0.17|||Fisher Exact|||The response rate based on participants with CR at \>4 weeks after RT.||0.17|0.00|0.17923
72581294|NCT00967330|144692074|SUPERIORITY_OR_OTHER||Difference in response rate|0.0||||1|TWO_SIDED|95.0|-0.08|0.08|||Fisher Exact|||The response rate based on participants with CR at Month 6.||0.08|-0.08|1.00000
72581295|NCT00967330|144692074|SUPERIORITY_OR_OTHER||Difference in response rate|0.25||||0.0021|TWO_SIDED|95.0|0.12|0.38|||Fisher Exact|||Response rate based on participants with CR or PR at 4 weeks after RT.||0.38|0.12|0.00210
72581296|NCT00967330|144692074|SUPERIORITY_OR_OTHER||Difference in response rate|0.1||||0.18761|TWO_SIDED|95.0|-0.02|0.23|||Fisher Exact|||Response rate based on participants with CR and PR at \>4 weeks after RT.||0.23|-0.02|0.18761
72581297|NCT00967330|144692074|SUPERIORITY_OR_OTHER||Difference in response rate|-0.05||||0.38974|TWO_SIDED|95.0|-0.18|0.07|||Fisher Exact|||Response rate based on participants with CR or PR at Month 6.||0.07|-0.18|0.38974
72581298|NCT00967330|144692076|SUPERIORITY_OR_OTHER||Least Square (LS) Mean Difference|2.1002||||0.4975|TWO_SIDED|95.0|-3.9855|8.186|||ANOVA|||Physical Functioning. Analysis of variance (ANOVA) included all post-baseline data (Months 3 through 21).||8.1860|-3.9855|0.4975
72581299|NCT00967330|144692076|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.4704||||0.76|TWO_SIDED|95.0|-10.9358|7.9951|||ANOVA|||Role Functioning. ANOVA included all post-baseline data (Months 3 through 21).||7.9951|-10.9358|0.7600
72412164|NCT02334800|144332352|SUPERIORITY_OR_OTHER||ratio of adjusted geometric mean|82.14|||||TWO_SIDED|90.0|63.83|105.71||||||||105.71|63.83|
72412165|NCT02334800|144332352|SUPERIORITY_OR_OTHER||ratio of adjusted geometric mean|134.9|||||TWO_SIDED|90.0|104.82|173.6||||||||173.60|104.82|
72581300|NCT00967330|144692076|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.02278||||0.9949|TWO_SIDED|95.0|-7.035|6.9895|||ANOVA|||Emotional Functioning. ANOVA included all post-baseline data (Months 3 through 21).||6.9895|-7.0350|0.9949
72581301|NCT00967330|144692076|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.8213||||0.6253|TWO_SIDED|95.0|-9.155|5.5125|||ANOVA|||Cognitive Functioning. ANOVA included all post-baseline data (Months 3 through 21).||5.5125|-9.1550|0.6253
72581302|NCT00967330|144692076|SUPERIORITY_OR_OTHER||LS Mean Difference|1.6126||||0.7219|TWO_SIDED|95.0|-7.2953|10.5205|||ANOVA|||Social Functioning. ANOVA included all post-baseline data (Months 3 through 21).||10.5205|-7.2953|0.7219
72581303|NCT00967330|144692076|SUPERIORITY_OR_OTHER||LS Mean Difference|3.4989||||0.2443|TWO_SIDED|95.0|-2.4046|9.4023|||ANOVA|||Global Health Status /QoL. ANOVA included all post-baseline data (Months 3 through 21).||9.4023|-2.4046|0.2443
72581304|NCT00967330|144692076|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.3449||||0.3287|TWO_SIDED|95.0|-10.0739|3.3841|||ANOVA|||Fatigue. ANOVA included all post-baseline data (Months 3 through 21).||3.3841|-10.0739|0.3287
72581305|NCT00967330|144692076|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.196||||0.0485|TWO_SIDED|95.0|-8.3635|-0.0285|||ANOVA|||Nausea/Vomiting. ANOVA included all post-baseline data (Months 3 through 21).||-0.02850|-8.3635|0.0485
72581306|NCT00967330|144692076|SUPERIORITY_OR_OTHER||LS Mean Difference|-9.095||||0.0354|TWO_SIDED|95.0|-17.5629|-0.6271|||ANOVA|||Pain. ANOVA included all post-baseline data (Months 3 through 21).||-0.6271|-17.5629|0.0354
72581307|NCT00967330|144692076|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.2088||||0.3724|TWO_SIDED|95.0|-10.2784|3.8608|||ANOVA|||Dyspnoea. ANOVA included all post-baseline data (Months 3 through 21).||3.8608|-10.2784|0.3724
72581308|NCT00967330|144692076|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.876||||0.2884|TWO_SIDED|95.0|-13.9002|4.1482|||ANOVA|||Insomnia. ANOVA included all post-baseline data (Months 3 through 21).||4.1482|-13.9002|0.2884
72581309|NCT00967330|144692076|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.782||||0.4081|TWO_SIDED|95.0|-9.3926|3.8282|||ANOVA|||Appetite loss. ANOVA included all post-baseline data (Months 3 through 21).||3.8282|-9.3926|0.4081
72581310|NCT00967330|144692076|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.9375||||0.275|TWO_SIDED|95.0|-11.0245|3.1495|||ANOVA|||Constipation. ANOVA included all post-baseline data (Months 3 through 21).||3.1495|-11.0245|0.2750
72581311|NCT00967330|144692076|SUPERIORITY_OR_OTHER||LS Mean Difference|-6.1685||||0.0213|TWO_SIDED|95.0|-11.4129|-0.9241|||ANOVA|||Diarrhoea. ANOVA included all post-baseline data (Months 3 through 21).||-0.9241|-11.4129|0.0213
72581312|NCT00967330|144692076|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.7295||||0.5201|TWO_SIDED|95.0|-11.0727|5.6137|||ANOVA|||Financial Problems. ANOVA included all post-baseline data (Months 3 through 21).||5.6137|-11.0727|0.5201
72581313|NCT00967330|144692077|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.2699||||0.3613|TWO_SIDED|95.0|-10.2983|3.7585|||ANOVA|||Future uncertainty. ANOVA included all post-baseline data (Months 3 through 21).||3.7585|-10.2983|0.3613
72581314|NCT00967330|144692077|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.1159||||0.6146|TWO_SIDED|95.0|-5.4654|3.2336|||ANOVA|||Visual disorder. ANOVA included all post-baseline data (Months 3 through 21).||3.2336|-5.4654|0.6146
72581315|NCT00967330|144692077|SUPERIORITY_OR_OTHER||LS Mean Difference|1.1014||||0.686|TWO_SIDED|95.0|-4.2449|6.4477|||ANOVA|||Motor dysfunction. ANOVA included all post-baseline data (Months 3 through 21).||6.4477|-4.2449|0.6860
72581316|NCT00967330|144692077|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1009||||0.9706|TWO_SIDED|95.0|-5.468|5.2663|||ANOVA|||Communication deficit. ANOVA included all post-baseline data (Months 3 through 21).||5.2663|-5.4680|0.9706
72412166|NCT02334800|144332352|SUPERIORITY_OR_OTHER||ratio of adjusted geometric mean|178.39|||||TWO_SIDED|90.0|138.62|229.57||||||||229.57|138.62|
72581317|NCT00967330|144692077|SUPERIORITY_OR_OTHER||LS Mean Difference|-8.3294||||0.0124|TWO_SIDED|95.0|-14.855|-1.8037|||ANOVA|||Headaches. ANOVA included all post-baseline data (Months 3 through 21).||-1.8037|-14.8550|0.0124
72581318|NCT00967330|144692077|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.0054||||0.5997|TWO_SIDED|95.0|-4.7654|2.7545|||ANOVA|||Seizures. ANOVA included all post-baseline data (Months 3 through 21).||2.7545|-4.7654|0.5997
72581319|NCT00967330|144692077|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.4399||||0.3458|TWO_SIDED|95.0|-10.6002|3.7204|||ANOVA|||Drowsiness. ANOVA included all post-baseline data (Months 3 through 21).||3.7204|-10.6002|0.3458
72581320|NCT00967330|144692077|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.5908||||0.2383|TWO_SIDED|95.0|-12.2279|3.0464|||ANOVA|||Hair loss. ANOVA included all post-baseline data (Months 3 through 21).||3.0464|-12.2279|0.2383
72581321|NCT00967330|144692077|SUPERIORITY_OR_OTHER||LS Mean Difference|0.9807||||0.7491|TWO_SIDED|95.0|-5.0373|6.9988|||ANOVA|||Itchy skin. ANOVA included all post-baseline data (Months 3 through 21).||6.9988|-5.0373|0.7491
72581322|NCT00967330|144692077|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.0341||||0.7755|TWO_SIDED|95.0|-8.1508|6.0827|||ANOVA|||Weakness of legs. ANOVA included all post-baseline data (Months 3 through 21).||6.0827|-8.1508|0.7755
72581323|NCT00967330|144692077|SUPERIORITY_OR_OTHER||LS Mean Difference|0.469||||0.841|TWO_SIDED|95.0|-4.1211|5.0591|||ANOVA|||Bladder control. ANOVA included all post-baseline data (Months 3 through 21).||5.0591|-4.1211|0.8410
72581324|NCT00967330|144692078|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1933||||0.0817|TWO_SIDED|95.0|-0.411|0.02438|||ANOVA|||Orientation to time and place. ANOVA included all post-baseline data (Months 3 through 21).||0.02438|-0.4110|0.0817
72581325|NCT00967330|144692078|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.02955||||0.0773|TWO_SIDED|95.0|-0.06234|0.003241|||ANOVA|||Immediate recall. ANOVA included all post-baseline data (Months 3 through 21).||0.003241|-0.06234|0.0773
72581326|NCT00967330|144692078|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1429||||0.2608|TWO_SIDED|95.0|-0.1065|0.3924|||ANOVA|||Repetitions required. ANOVA included all post-baseline data (Months 3 through 21).||0.3924|-0.1065|0.2608
72581327|NCT00967330|144692078|SUPERIORITY_OR_OTHER||LS Mean Difference|0.003262||||0.9836|TWO_SIDED|95.0|-0.3092|0.3158|||ANOVA|||Calculations. ANOVA included all post-baseline data (Months 3 through 21).||0.3158|-0.3092|0.9836
72581328|NCT00967330|144692078|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.03782||||0.661|TWO_SIDED|95.0|-0.2071|0.1315|||ANOVA|||Short-term verbal memory. ANOVA included all post-baseline data (Months 3 through 21).||0.1315|-0.2071|0.6610
72581329|NCT00967330|144692078|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.08037||||0.4464|TWO_SIDED|95.0|-0.2875|0.1268|||ANOVA|||Language and construct ability. ANOVA included all post-baseline data (Months 3 through 21).||0.1268|-0.2875|0.4464
72581330|NCT00967330|144692078|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3128||||0.4717|TWO_SIDED|95.0|-1.1658|0.5402|||ANOVA|||Total score. ANOVA included all post-baseline data (Months 3 through 21).||0.5402|-1.1658|0.4717
72581331|NCT00967330|144692079|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.151||||0.2078|TWO_SIDED|95.0|-5.4983|1.1963|||ANOVA|||KPS score. ANOVA included all post-baseline data (Months 3 through 21).||1.1963|-5.4983|0.2078
72581332|NCT02623725|144692082|NON_INFERIORITY|The overall non-inferiority of the booster dose was to be demonstrated if the lower limit of the two-sided 95 percent (%) Confidence Interval (CI) of the Geometric mean of titer ratios (GMTRs) (booster vs post-dose 3) was greater than (\>) 1/2 for each serotype.|Geometric mean of titer ratio|1.66|||||TWO_SIDED|95.0|1.33|2.06||||||Dengue Virus Serotype 1||2.06|1.33|
72581333|NCT02623725|144692082|NON_INFERIORITY|The overall non-inferiority of the booster dose was to be demonstrated if the lower limit of the two-sided 95% CI of the GMTRs (booster vs post-dose 3) was \>1/2 for each serotype.|Geometric mean of titer ratio|1.82|||||TWO_SIDED|95.0|1.43|2.31||||||Dengue Virus Serotype 2||2.31|1.43|
72581334|NCT02623725|144692082|NON_INFERIORITY|The overall non-inferiority of the booster dose was to be demonstrated if the lower limit of the two-sided 95% CI of the GMTRs (booster vs post-dose 3) was \>1/2 for each serotype.|Geometric mean of titer ratio|1.04|||||TWO_SIDED|95.0|0.841|1.27||||||Dengue Virus Serotype 3||1.27|0.841|
72581335|NCT02623725|144692082|NON_INFERIORITY|The overall non-inferiority of the booster dose was to be demonstrated if the lower limit of the two-sided 95% CI of the GMTRs (booster vs post-dose 3) was \>1/2 for each serotype.|Geometric mean of titer ratio|1.32|||||TWO_SIDED|95.0|1.01|1.74||||||Dengue Virus Serotype 4||1.74|1.01|
72581336|NCT02623725|144692083|SUPERIORITY|The superiority was to be demonstrated if the lower limit of the two-sided 95% CI for the ratio was \>1.|Geometric mean of titer ratio|1.66|||||TWO_SIDED|95.0|1.34|2.05||||||Dengue Virus Serotype 1||2.05|1.34|
72581337|NCT02623725|144692083|SUPERIORITY|The superiority was to be demonstrated if the lower limit of the two-sided 95% CI for the ratio was \>1.|Geometric mean of titer ratio|1.89|||||TWO_SIDED|95.0|1.49|2.41||||||Dengue Virus Serotype 2||2.41|1.49|
72581338|NCT02623725|144692083|SUPERIORITY|The superiority was to be demonstrated if the lower limit of the two-sided 95% CI for the ratio was \>1.|Geometric mean of titer ratio|1.06|||||TWO_SIDED|95.0|0.86|1.3||||||Dengue Virus Serotype 3||1.30|0.860|
72581339|NCT02623725|144692083|SUPERIORITY|The superiority was to be demonstrated if the lower limit of the two-sided 95% CI for the ratio was \>1.|Geometric mean of titer ratio|1.33|||||TWO_SIDED|95.0|1.02|1.73||||||Dengue Virus Serotype 4||1.73|1.02|
72547455|NCT03679741|144624175|NON_INFERIORITY|A non-inferiority margin of -5 points was used. This margin is based on a 10% shift in the distribution of CLUE scores.|Mean Difference (Final Values)|2.5|STANDARD_DEVIATION|1.56|||TWO_SIDED|95.0|-0.6|5.5|||Bayesian multivariate normal model|for random effects|Mean difference was calculated as test minus control|Sample size was based on primary endpoints only.||5.5|-0.6|
72547456|NCT03679741|144624176|NON_INFERIORITY|A cumulative odds ratio non-inferiority margin of 0.67 was used. This margin is based on no more than a 10% difference in proportion between the Test and the Control lenses. The odds ratio represents the cumulative odds ratio of having a higher rating/experience of the Test lens compared to the Control lens.|Odds Ratio (OR)|1.73|STANDARD_DEVIATION|0.459|||TWO_SIDED|95.0|1.0|2.82|||Bayesian multinomial random-effects|A 95% Credible Interval for the odds ratio, was used to test for non-inferiority.|Odds ratio was calculated as test over control|||2.82|1.00|
72547457|NCT01860976|144624182|SUPERIORITY_OR_OTHER_LEGACY||Estimate of Difference|17.2|||<|0.001|TWO_SIDED|95.0|8.7|25.6|||Cochran-Mantel-Haenszel|||||25.6|8.7|<0.001
72547458|NCT02419313|144624244|SUPERIORITY_OR_OTHER|||||||0.0007|TWO_SIDED||||||Fisher Exact|||||||0.0007
72547459|NCT02419313|144624245|SUPERIORITY_OR_OTHER|||||||0.0008|TWO_SIDED||||||Fisher Exact|||||||0.0008
72547460|NCT02419313|144624246|SUPERIORITY_OR_OTHER|||||||0.0105|TWO_SIDED||||||Fisher Exact|||||||0.0105
72547461|NCT00620763|144624250|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.0|STANDARD_ERROR_OF_MEAN|2.0||0.02||95.0|||||Mixed Models Analysis|Mixed model analysis of variance tested for treatment and feeding sequence effects.||16 subjects required to detect a difference in Calcium 47 absorption of 2 percentage points with 90% power, alpha = 0.05||||0.02
72547462|NCT00368966|144624256|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) greater than (\>) -10%.|Difference|-0.6||||||95.0|-2.9|1.6||||||For Meningococcal C the difference in percentage between the two groups (13vPnC - 7vPnC) at ≥ 1:8 threshold was calculated||1.6|-2.9|
72547463|NCT00368966|144624256|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|1.2||||||95.0|-2.3|4.9||||||For Diphtheria the difference in percentage between the two groups (13vPnC - 7vPnC) at ≥ 0.10 IU/mL threshold was calculated||4.9|-2.3|
72547464|NCT00368966|144624256|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|0.0||||||95.0|-1.3|1.3||||||For Diphtheria the difference in percentage between the two groups (13vPnC - 7vPnC) at ≥ 0.01 IU/mL threshold was calculated||1.3|-1.3|
72581340|NCT01402570|144692105|SUPERIORITY_OR_OTHER||REML|0.17||||0.66|TWO_SIDED|95.0|-0.67|0.95||Time was predictor of interest, controlling for age, gender, baseline PROMIS physical functioning, and overall functional status.|Mixed Models Analysis|||Linear mixed modeling (LMM) with random effects for intercept and repeated effects for assessment period was used to analyze change over time for study outcomes. The primary predictor of interest in this study was the relationship of time to each of the outcomes to evaluate the potential effect of the intervention. Independent LMMs were used to study outcomes.||0.95|-0.67|0.66
72547465|NCT00368966|144624257|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for immune response induced by Meningitec was declared if the lower bound of the 2-sided, 95% CI for the GMT ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|0.72||||||95.0|0.6|0.86||||||For Meningococcal C the GMT ratio (13vPnC/7vPnC) was calculated||0.86|0.60|
72547466|NCT00368966|144624258|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for immune response induced by Meningitec was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|0.81||||||95.0|0.7|0.94||||||For Diphtheria the GMC ratio (13vPnC/7vPnC) was calculated||0.94|0.70|
72547467|NCT00368966|144624261|SUPERIORITY_OR_OTHER||Difference|1.23||||||95.0|1.13|1.35||||||For serotype 4, the Geometric Mean fold Rise (GMFR) were calculated using all participants with available data from both 13vPnC After Infant Series Dose 2 and 13vPnC After Infant Series Dose 3 blood draws.||1.35|1.13|
72547468|NCT00368966|144624261|SUPERIORITY_OR_OTHER||Difference|9.28||||||95.0|8.18|10.53||||||For serotype 6B the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||10.53|8.18|
72547469|NCT00368966|144624261|SUPERIORITY_OR_OTHER||Difference|1.15||||||95.0|1.05|1.25||||||For serotype 6B, the GMFR were calculated using all participants with available data from both 13vPnC After Infant Series Dose 2 and 13vPnC After Infant Series Dose 3 blood draws.||1.25|1.05|
72412167|NCT02334800|144332355|SUPERIORITY_OR_OTHER||ratio of adjusted geometric mean|107.37|||||TWO_SIDED|90.0|78.06|147.68||||||||147.68|78.06|
72547470|NCT00368966|144624261|SUPERIORITY_OR_OTHER||Difference|1.61||||||95.0|1.41|1.83||||||For serotype 14, the GMFR were calculated using all participants with available data from both 13vPnC After Infant Series Dose 2 and 13vPnC After Infant Series Dose 3 blood draws.||1.83|1.41|
72547471|NCT00368966|144624261|SUPERIORITY_OR_OTHER||Difference|1.45||||||95.0|1.3|1.61||||||For serotype 18C, the GMFR were calculated using all participants with available data from both 13vPnC After Infant Series Dose 2 and 13vPnC After Infant Series Dose 3 blood draws.||1.61|1.30|
72547472|NCT00368966|144624261|SUPERIORITY_OR_OTHER||Difference|0.93||||||95.0|0.83|1.03||||||For serotype 19F, the GMFR were calculated using all participants with available data from both 13vPnC After Infant Series Dose 2 and 13vPnC After Infant Series Dose 3 blood draws.||1.03|0.83|
72547473|NCT00368966|144624261|SUPERIORITY_OR_OTHER||Difference|4.0||||||95.0|3.55|4.5||||||For serotype 23F, the GMFR were calculated using all participants with available data from both 13vPnC After Infant Series Dose 2 and 13vPnC After Infant Series Dose 3 blood draws.||4.50|3.55|
72547474|NCT00368966|144624261|SUPERIORITY_OR_OTHER||Difference|1.6||||||95.0|1.46|1.76||||||For serotype 1, the GMFR were calculated using all participants with available data from both 13vPnC After Infant Series Dose 2 and 13vPnC After Infant Series Dose 3 blood draws.||1.76|1.46|
72547475|NCT00368966|144624261|SUPERIORITY_OR_OTHER||Difference|1.23||||||95.0|1.13|1.35||||||For serotype 3, the GMFR were calculated using all participants with available data from both 13vPnC After Infant Series Dose 2 and 13vPnC After Infant Series Dose 3 blood draws.||1.35|1.13|
72412168|NCT02334800|144332355|SUPERIORITY_OR_OTHER||ratio of adjusted geometric mean|137.5|||||TWO_SIDED|90.0|99.96|189.12||||||||189.12|99.96|
72581341|NCT01402570|144692106|SUPERIORITY_OR_OTHER||REML|0.0||||0.44|TWO_SIDED|95.0|-0.01|0.02||Time was predictor of interest, controlling for age, gender, baseline sleep efficiency, and overall functional status.|Mixed Models Analysis|||Linear mixed modeling (LMM) with random effects for intercept and repeated effects for assessment period was used to analyze change over time for study outcomes. The primary predictor of interest in this study was the relationship of time to each of the outcomes to evaluate the potential effect of the intervention. Independent LMMs were used to study outcomes.||0.02|-0.01|0.44
72547476|NCT00368966|144624261|SUPERIORITY_OR_OTHER||Difference|1.94||||||95.0|1.78|2.11||||||For serotype 5, the GMFR were calculated using all participants with available data from both 13vPnC After Infant Series Dose 2 and 13vPnC After Infant Series Dose 3 blood draws.||2.11|1.78|
72547477|NCT00368966|144624261|SUPERIORITY_OR_OTHER||Difference|2.87||||||95.0|2.58|3.2||||||For serotype 6A, the GMFR were calculated using all participants with available data from both 13vPnC After Infant Series Dose 2 and 13vPnC After Infant Series Dose 3 blood draws.||3.20|2.58|
72547478|NCT00368966|144624261|SUPERIORITY_OR_OTHER||Difference|2.18||||||95.0|1.98|2.41||||||For serotype 7F, the GMFR were calculated using all participants with available data from both 13vPnC After Infant Series Dose 2 and 13vPnC After Infant Series Dose 3 blood draws.||2.41|1.98|
72581342|NCT01402570|144692107|SUPERIORITY_OR_OTHER||REML|145.54||||0.35|TWO_SIDED|95.0|-178.93|470.02||Time was predictor of interest, controlling for age, gender, baseline steps per day, and overall functional status.|Mixed Models Analysis|||Linear mixed modeling (LMM) with random effects for intercept and repeated effects for assessment period was used to analyze change over time for study outcomes. The primary predictor of interest in this study was the relationship of time to each of the outcomes to evaluate the potential effect of the intervention. Independent LMMs were used to study outcomes.||470.02|-178.93|0.35
72547479|NCT00368966|144624261|SUPERIORITY_OR_OTHER||Difference|1.3||||||95.0|1.18|1.44||||||For serotype 19A, the GMFR were calculated using all participants with available data from both 13vPnC After Infant Series Dose 2 and 13vPnC After Infant Series Dose 3 blood draws.||1.44|1.18|
72547480|NCT00368966|144624262|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|0.0||||||95.0|-1.3|1.3||||||For Pertussis, PT the difference in percentage between the two groups (13vPnC - 7vPnC) at 5.0 EU/mL threshold was calculated||1.3|-1.3|
72412169|NCT02334800|144332355|SUPERIORITY_OR_OTHER||ratio of adjusted geometric mean|172.27|||||TWO_SIDED|90.0|125.25|236.96||||||||236.96|125.25|
72412170|NCT02703844|144332369|SUPERIORITY|||||||0.0089|||||||ANCOVA|||||||0.0089
72547481|NCT00368966|144624262|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|-1.9||||||95.0|-6.0|2.0||||||For Pertussis, PT the difference in percentage between the two groups (13vPnC - 7vPnC) at 20 EU/mL threshold was calculated||2.0|-6.0|
72547482|NCT00368966|144624262|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|0.0||||||95.0|-1.3|1.3||||||For Pertussis, FHA the difference in percentage between the two groups (13vPnC - 7vPnC) at 5.0 EU/mL threshold was calculated||1.3|-1.3|
72412171|NCT02828111|144332384|OTHER|Pairwise comparison||||||0.132|||||||ANCOVA|ANCOVA with treatment group as a factor and using Baseline value as a covariate||at Week 12||||0.132
72412172|NCT02828111|144332384|OTHER|Pairwise comparison||||||0.658|||||||ANCOVA|ANCOVA with treatment group as a factor and using Baseline value as a covariate||at Week 12||||0.658
72581343|NCT01402570|144692108|SUPERIORITY_OR_OTHER||REML|-1.05||||0.07|TWO_SIDED|95.0|-2.21|0.1||Time was predictor of interest, controlling for age, gender, baseline fatigue, and overall functional status.|Mixed Models Analysis|||Linear mixed modeling (LMM) with random effects for intercept and repeated effects for assessment period was used to analyze change over time for study outcomes. The primary predictor of interest in this study was the relationship of time to each of the outcomes to evaluate the potential effect of the intervention. Independent LMMs were used to study outcomes.||0.10|-2.21|0.07
72581344|NCT03514459|144692109|SUPERIORITY||Prevalence ratio|1.84|||<|0.001|TWO_SIDED|95.0|1.54|2.2|||Poisson regression|Robust standard errors||||2.20|1.54|<0.001
72412173|NCT02828111|144332384|OTHER|Pairwise comparison||||||0.142|||||||ANCOVA|ANCOVA with treatment group as a factor and using Baseline value as a covariate||at Week 12||||0.142
72412174|NCT02828111|144332384|OTHER|Pairwise comparison||||||0.207|||||||ANCOVA|ANCOVA with treatment group as a factor and using Baseline value as a covariate||at Week 12||||0.207
72412175|NCT02828111|144332384|OTHER|Pairwise comparison||||||0.077|||||||ANCOVA|ANCOVA with treatment group as a factor and using Baseline value as a covariate||This is the analysis of combined patidegib gel 2% once daily and twice daily compared with vehicle gel at Week 12.||||0.077
72547483|NCT00368966|144624262|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|0.0||||||95.0|-1.3|1.3||||||For Pertussis, FHA the difference in percentage between the two groups (13vPnC - 7vPnC) at 7.82 EU/mL threshold was calculated||1.3|-1.3|
72547484|NCT00368966|144624262|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|-1.3||||||95.0|-5.2|2.6||||||For Pertussis, FHA the difference in percentage between the two groups (13vPnC - 7vPnC) at 64 EU/mL threshold was calculated||2.6|-5.2|
72581345|NCT00080912|144692115|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The original sample size was determined based on the non-inferiority. The original sample size is based on assumption of response rate on the multiple fraction arm is 70%, 260 patients were required in each treatment arm to have 80% power to exclude, with a one sided alpha of 0.05, a response rate of 60% or less in the single fraction radiation group (non-inferiority margin =10%). Given an inevaluability rate of 30%, 850 patients (425 for each treatment arm) were randomized to the study.|Risk Difference (RD)|4.0||||0.03|ONE_SIDED|95.0||9.2||p-value is for one-sided non-inferiority test|Cochran-Mantel-Haenszel||The upper limit of one-sided 95% CI for the response rate difference was 9.2%, which was below the pre-specified 10% non-inferiority boundary|||9.2||0.03
72581346|NCT02099786|144692116|SUPERIORITY||Odds Ratio (OR)|2.2||||0.27|TWO_SIDED|95.0|0.55|8.8|||Regression, Logistic|||Null hypothesis: There is no difference in the number of participants with ASHA-significant threshold shifts between treatment arms.||8.8|.55|.27
72412176|NCT02828111|144332384|OTHER|Pairwise comparison||||||0.331|||||||ANCOVA|ANCOVA with treatment group as a factor and using Baseline value as a covariate||This is the analysis of combined patidegib gel 4% once daily and twice daily compared with vehicle gel at Week 12.||||0.331
72412177|NCT02828111|144332384|OTHER|Pairwise comparison||||||0.117|||||||ANCOVA|ANCOVA with treatment group as a factor and using Baseline value as a covariate||This is the analysis of all four patidegib gel treatment groups combined compared with vehicle gel at Week 12.||||0.117
72547485|NCT00368966|144624262|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|0.0||||||95.0|-1.3|1.3||||||For Pertussis, PRN the difference in percentage between the two groups (13vPnC - 7vPnC) at 5 EU/mL threshold was calculated||1.3|-1.3|
72581347|NCT02099786|144692116|SUPERIORITY||Odds Ratio (OR)|1.4||||0.67|TWO_SIDED|95.0|0.3|5.9|||Regression, Logistic|||Null hypothesis: There is no difference in the number of participants with CTCAE grade 1 or greater hearing loss between treatment arms.||5.9|.3|.67
72581348|NCT02099786|144692117|SUPERIORITY||Odds Ratio (OR)|0.92||||0.88|TWO_SIDED|95.0|0.29|2.9|||Regression, Logistic|||Null hypothesis is no difference in audiology clinic use between treatment arms.||2.9|.29|.88
72581349|NCT02099786|144692118|NON_INFERIORITY|We require a non-inferiority margin of no more than 1.1 mortality odds among COMP-VA patients relative to Usual Care patients. This means that the upper 95% confidence bound for the fitted odds ratio must be less than 1.1 to reject the null hypothesis that COMP-VA induces extra mortality risk.|Odds Ratio (OR)|1.9|||||ONE_SIDED|||||||||||||
72581350|NCT02099786|144692119|SUPERIORITY|||||||0.72||||||The a priori threshold for statistical significance is .05|t-test, 2 sided|||||||.72
72412178|NCT02828111|144332388|OTHER|Pairwise comparison||||||0.038|||||||ANCOVA|ANCOVA with treatment group as a factor and using Baseline value as a covariate||at Week 12||||0.038
72412179|NCT02828111|144332388|OTHER|Pairwise comparison||||||0.099|||||||ANCOVA|ANCOVA with treatment group as a factor and using Baseline value as a covariate||at Week 12||||0.099
72412180|NCT02828111|144332388|OTHER|Pairwise comparison||||||0.198|||||||ANCOVA|ANCOVA with treatment group as a factor and using Baseline value as a covariate||at Week 12||||0.198
72412181|NCT02828111|144332388|OTHER|Pairwise comparison||||||0.757|||||||ANCOVA|ANCOVA with treatment group as a factor and using Baseline value as a covariate||at Week 12||||0.757
72412182|NCT02828111|144332389|OTHER|Pairwise comparison||||||0.043|||||||Fisher Exact|||at Week 12||||0.043
72412183|NCT02828111|144332389|OTHER|Pairwise comparison||||||0.312|||||||Fisher Exact|||at Week 12||||0.312
72412184|NCT02828111|144332389|OTHER|Pairwise comparison||||||0.353|||||||Fisher Exact|||at Week 12||||0.353
72581351|NCT01999920|144692163|SUPERIORITY|||||||0.064|||||||Mixed Models Analysis|||||||.064
72581352|NCT01999920|144692164|SUPERIORITY||Standard error|5.5|STANDARD_ERROR_OF_MEAN|3.13||0.11|TWO_SIDED|95.0|-1.32|12.32|||Mixed Models Analysis|||||12.32|-1.32|0.11
72581353|NCT01999920|144692165|SUPERIORITY||Standard error|0.34|STANDARD_ERROR_OF_MEAN|2.44||0.89|TWO_SIDED|95.0|-4.85|5.53|||Mixed Models Analysis|||Confidence variable||5.53|-4.85|0.89
72412185|NCT02828111|144332389|OTHER|Pairwise comparison||||||0.093|||||||Fisher Exact|||This is the analysis of combined patidegib gel 2% once daily and twice daily compared with vehicle gel at Week 12.||||0.093
72547486|NCT00368966|144624262|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|-0.6||||||95.0|-4.4|3.2||||||For Pertussis, PRN the difference in percentage between the two groups (13vPnC - 7vPnC) at 39 EU/mL threshold was calculated||3.2|-4.4|
72547487|NCT00368966|144624262|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|0.0||||||95.0|-1.7|1.7||||||For Pertussis, PT the difference in percentage between the two groups (13vPnC - 7vPnC) at 5.0 EU/mL threshold was calculated||1.7|-1.7|
72547488|NCT00368966|144624262|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|-1.4||||||95.0|-5.1|2.2||||||For Pertussis, PT the difference in percentage between the two groups (13vPnC - 7vPnC) at 11 EU/mL threshold was calculated||2.2|-5.1|
72547489|NCT00368966|144624262|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|0.0||||||95.0|-1.4|1.4||||||For Pertussis, FHA the difference in percentage between the two groups (13vPnC - 7vPnC) at 5.0 EU/mL threshold was calculated||1.4|-1.4|
72547490|NCT00368966|144624262|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|0.0||||||95.0|-1.4|1.4||||||For Pertussis, FHA the difference in percentage between the two groups (13vPnC - 7vPnC) at 7.82 EU/mL threshold was calculated||1.4|-1.4|
72547491|NCT00368966|144624262|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|-0.6||||||95.0|-4.6|3.3||||||For Pertussis, FHA the difference in percentage between the two groups (13vPnC - 7vPnC) at 99 EU/mL threshold was calculated||3.3|-4.6|
72547492|NCT00368966|144624262|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|0.0||||||95.0|-1.4|1.4||||||For Pertussis, PRN the difference in percentage between the two groups (13vPnC - 7vPnC) at 5 EU/mL threshold was calculated||1.4|-1.4|
72547493|NCT00368966|144624262|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|-1.7||||||95.0|-5.8|2.3||||||For Pertussis, PRN the difference in percentage between the two groups (13vPnC - 7vPnC) at 69 EU/mL threshold was calculated||2.3|-5.8|
72547494|NCT00368966|144624262|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|-0.7|||||TWO_SIDED|95.0|-2.5|0.7||||||For Diphtheria the difference in percentage between the two groups (13vPnC - 7vPnC) at 0.10 IU/mL threshold was calculated||0.7|-2.5|
72412186|NCT02828111|144332389|OTHER|Pairwise comparison||||||1|||||||Fisher Exact|||This is the analysis of combined patidegib gel 4% once daily and twice daily compared with vehicle gel at Week 12.||||1.000
72547495|NCT00368966|144624262|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|0.0|||||TWO_SIDED|95.0|-1.3|1.3||||||For Diphtheria the difference in percentage between the two groups (13vPnC - 7vPnC) at 0.01 IU/mL threshold was calculated||1.3|-1.3|
72547496|NCT00368966|144624262|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|-0.8|||||TWO_SIDED|95.0|-2.8|0.8||||||For Diphtheria the difference in percentage between the two groups (13vPnC - 7vPnC) at 0.10 IU/mL threshold was calculated||0.8|-2.8|
72547497|NCT00368966|144624262|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|0.0|||||TWO_SIDED|95.0|-1.5|1.5||||||For Diphtheria the difference in percentage between the two groups (13vPnC - 7vPnC) at 0.01 IU/mL threshold was calculated||1.5|-1.5|
72547498|NCT00368966|144624262|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|0.4|||||TWO_SIDED|95.0|-2.1|2.9||||||For Tetanus the difference in percentage between the two groups (13vPnC - 7vPnC) at 0.10 IU/mL threshold was calculated||2.9|-2.1|
72547499|NCT00368966|144624262|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|0.0|||||TWO_SIDED|95.0|-1.3|1.3||||||For Tetanus the difference in percentage between the two groups (13vPnC - 7vPnC) at 0.01 IU/mL threshold was calculated||1.3|-1.3|
72547500|NCT00368966|144624262|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|0.8|||||TWO_SIDED|95.0|-2.1|3.8||||||For Tetanus the difference in percentage between the two groups (13vPnC - 7vPnC) at 0.10 IU/mL threshold was calculated||3.8|-2.1|
72547501|NCT00368966|144624262|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|0.0|||||TWO_SIDED|95.0|-1.8|1.7||||||For Tetanus the difference in percentage between the two groups (13vPnC - 7vPnC) at 0.01 IU/mL threshold was calculated||1.7|-1.8|
72547502|NCT00368966|144624262|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|0.0|||||TWO_SIDED|95.0|-1.4|1.3||||||For Poliovirus Type 1 the difference in percentage between the two groups (13vPnC - 7vPnC) at 1:8 threshold was calculated||1.3|-1.4|
72547503|NCT00368966|144624262|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|0.7|||||TWO_SIDED|95.0|-0.6|2.6||||||For Poliovirus Type 2 the difference in percentage between the two groups (13vPnC - 7vPnC) at 1:8 threshold was calculated||2.6|-0.6|
72547504|NCT00368966|144624262|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|0.4|||||TWO_SIDED|95.0|-1.0|2.0||||||For Poliovirus Type 3 the difference in percentage between the two groups (13vPnC - 7vPnC) at 1:8 threshold was calculated||2.0|-1.0|
72547505|NCT00368966|144624262|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|0.0|||||TWO_SIDED|95.0|-1.5|1.5||||||For Poliovirus Type 1 the difference in percentage between the two groups (13vPnC - 7vPnC) at 1:8 EU/mL threshold was calculated||1.5|-1.5|
72547506|NCT00368966|144624262|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|0.4|||||TWO_SIDED|95.0|-1.1|2.2||||||For Poliovirus Type 2 the difference in percentage between the two groups (13vPnC - 7vPnC) at 1:8 EU/mL threshold was calculated||2.2|-1.1|
72547507|NCT00368966|144624262|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|0.0|||||TWO_SIDED|95.0|-1.5|1.5||||||For Poliovirus Type 3 the difference in percentage between the two groups (13vPnC - 7vPnC) at 1:8 EU/mL threshold was calculated||1.5|-1.5|
72547508|NCT00368966|144624263|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMT ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|1.0||||||95.0|0.82|1.23||||||For Poliovirus Type 1 the GMT ratio (13vPnC/7vPnC) was calculated||1.23|0.82|
72547509|NCT00368966|144624263|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMT ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|0.94||||||95.0|0.76|1.18||||||For Poliovirus Type 2 the GMT ratio (13vPnC/7vPnC) was calculated||1.18|0.76|
72547510|NCT00368966|144624263|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMT ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|0.95||||||95.0|0.76|1.19||||||For Poliovirus Type 3 the GMT ratio (13vPnC/7vPnC) was calculated||1.19|0.76|
72547511|NCT00368966|144624263|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMT ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|0.82||||||95.0|0.69|0.98||||||For Poliovirus Type 1 the GMT ratio (13vPnC/7vPnC) was calculated||0.98|0.69|
72547512|NCT00368966|144624263|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMT ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|0.9||||||95.0|0.75|1.09||||||For Poliovirus Type 2 the GMT ratio (13vPnC/7vPnC) was calculated||1.09|0.75|
72547513|NCT00368966|144624263|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMT ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|1.07||||||95.0|0.88|1.29||||||For Poliovirus Type 3 the GMT ratio (13vPnC/7vPnC) was calculated||1.29|0.88|
72547514|NCT00368966|144624264|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|0.85||||||95.0|0.75|0.96||||||For diphtheria toxoid the GMC ratio (13vPnC/7vPnC) was calculated||0.96|0.75|
72547515|NCT00368966|144624264|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|1.03||||||95.0|0.88|1.2||||||For Tetanus the GMC ratio (13vPnC/7vPnC) was calculated||1.20|0.88|
72547516|NCT00368966|144624264|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|0.86||||||95.0|0.71|1.02||||||For diphtheria toxoid the GMC ratio (13vPnC/7vPnC) was calculated||1.02|0.71|
72547517|NCT00368966|144624264|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|1.12||||||95.0|0.9|1.4||||||For Tetanus the GMC ratio (13vPnC/7vPnC) was calculated||1.40|0.90|
72547518|NCT00368966|144624265|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|1.03||||||95.0|0.93|1.13||||||For Pertussis PT the GMC ratio (13vPnC/7vPnC) was calculated||1.13|0.93|
72581354|NCT01999920|144692165|SUPERIORITY||Standard error|1.18|STANDARD_ERROR_OF_MEAN|4.41||0.79|TWO_SIDED|95.0|-8.21|10.58|||Mixed Models Analysis|||Discomfort with Closeness variable||10.58|-8.21|0.79
72547519|NCT00368966|144624265|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|1.07||||||95.0|0.96|1.2||||||For Pertussis FHA the GMC ratio (13vPnC/7vPnC) was calculated||1.20|0.96|
72547520|NCT00368966|144624265|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|1.05||||||95.0|0.92|1.18||||||For Pertussis PRN the GMC ratio (13vPnC/7vPnC) was calculated||1.18|0.92|
72547521|NCT00368966|144624265|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|1.0||||||95.0|0.88|1.14||||||For Pertussis PT the GMC ratio (13vPnC/7vPnC) was calculated||1.14|0.88|
72547522|NCT00368966|144624265|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|1.01||||||95.0|0.88|1.15||||||For Pertussis FHA the GMC ratio (13vPnC/7vPnC) was calculated||1.15|0.88|
72547523|NCT00368966|144624265|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|0.89||||||95.0|0.78|1.02||||||For Pertussis PRN the GMC ratio (13vPnC/7vPnC) was calculated||1.02|0.78|
72547524|NCT00368966|144624266|SUPERIORITY_OR_OTHER||Difference|2.2||||||95.0|0.1|4.4||||||For serotype 4, the difference in percentages between the two groups (13vPnC After Infant Series Dose 2 - 13vPnC After Infant Series Dose 3) was calculated||4.4|0.1|
72581355|NCT01999920|144692165|SUPERIORITY||Standard error|3.94|STANDARD_ERROR_OF_MEAN|3.79||0.31|TWO_SIDED|95.0|-4.12|12.01|||Mixed Models Analysis|||Relationships as Secondary variable||12.01|-4.12|0.31
72547525|NCT00368966|144624266|SUPERIORITY_OR_OTHER||Difference|41.2||||||95.0|34.9|46.9||||||For serotype 6B, the difference in percentages between the two groups (13vPnC After Infant Series Dose 2 - 13vPnC After Infant Series Dose 3) was calculated||46.9|34.9|
72547526|NCT00368966|144624266|SUPERIORITY_OR_OTHER||Difference|7.3||||||95.0|4.1|10.4||||||For serotype 9V, the difference in percentages between the two groups (13vPnC After Infant Series Dose 2 - 13vPnC After Infant Series Dose 3) was calculated||10.4|4.1|
72547527|NCT00368966|144624266|SUPERIORITY_OR_OTHER||Difference|-1.1||||||95.0|-3.4|1.2||||||For serotype 14, the difference in percentages between the two groups (13vPnC After Infant Series Dose 2 - 13vPnC After Infant Series Dose 3) was calculated||1.2|-3.4|
72547528|NCT00368966|144624266|SUPERIORITY_OR_OTHER||Difference|6.4||||||95.0|3.1|9.5||||||For serotype 18C, the difference in percentages between the two groups (13vPnC After Infant Series Dose 2 - 13vPnC After Infant Series Dose 3) was calculated||9.5|3.1|
72581356|NCT01999920|144692165|SUPERIORITY||Standard error|-2.6|STANDARD_ERROR_OF_MEAN|1.49||0.1|TWO_SIDED|95.0|-5.79|0.58|||Mixed Models Analysis|||Need for Approval variable||0.58|-5.79|0.10
72581357|NCT01999920|144692165|SUPERIORITY||Standard error|0.71|STANDARD_ERROR_OF_MEAN|2.82||0.8|TWO_SIDED|95.0|-5.3|6.72|||Mixed Models Analysis|||Preoccupation with Relationships variable||6.72|-5.30|0.80
72547529|NCT00368966|144624266|SUPERIORITY_OR_OTHER||Difference|1.5||||||95.0|-0.4|3.4||||||For serotype 19F, the difference in percentages between the two groups (13vPnC After Infant Series Dose 2 - 13vPnC After Infant Series Dose 3) was calculated||3.4|-0.4|
72547530|NCT00368966|144624266|SUPERIORITY_OR_OTHER||Difference|26.5||||||95.0|20.7|31.9||||||For serotype 23F, the difference in percentages between the two groups (13vPnC After Infant Series Dose 2 - 13vPnC After Infant Series Dose 3) was calculated||31.9|20.7|
72547531|NCT00368966|144624266|SUPERIORITY_OR_OTHER||Difference|3.0||||||95.0|0.8|5.1||||||For serotype 1, the difference in percentages between the two groups (13vPnC After Infant Series Dose 2 - 13vPnC After Infant Series Dose 3) was calculated||5.1|0.8|
72547532|NCT00368966|144624266|SUPERIORITY_OR_OTHER||Difference|2.2||||||95.0|-1.8|6.3||||||For serotype 3, the difference in percentages between the two groups (13vPnC After Infant Series Dose 2 - 13vPnC After Infant Series Dose 3) was calculated||6.3|-1.8|
72547533|NCT00368966|144624266|SUPERIORITY_OR_OTHER||Difference|10.0||||||95.0|5.9|13.9||||||For serotype 5, the difference in percentages between the two groups (13vPnC After Infant Series Dose 2 - 13vPnC After Infant Series Dose 3) was calculated||13.9|5.9|
72547534|NCT00368966|144624266|SUPERIORITY_OR_OTHER||Difference|13.0||||||95.0|8.6|17.2||||||For serotype 6A, the difference in percentages between the two groups (13vPnC After Infant Series Dose 2 - 13vPnC After Infant Series Dose 3) was calculated||17.2|8.6|
72581358|NCT01999920|144692166|SUPERIORITY||Standard error|-19.91|STANDARD_ERROR_OF_MEAN|6.99||0.008|TWO_SIDED|95.0|-34.23|-5.58|||Mixed Models Analysis|||||-5.58|-34.23|0.008
72581359|NCT01999920|144692167|SUPERIORITY||Standard error|3.29|STANDARD_ERROR_OF_MEAN|1.43||0.026|TWO_SIDED|95.0|0.42|6.16|||Mixed Models Analysis|||||6.16|0.42|0.026
72581360|NCT01999920|144692168|SUPERIORITY||Standard error|21.38|STANDARD_ERROR_OF_MEAN|7.65||0.01|TWO_SIDED|95.0|5.64|37.11|||Mixed Models Analysis|||||37.11|5.64|0.01
72581361|NCT04620746|144692201|SUPERIORITY|||||||0.98|||||||Chi-squared, Corrected|||||||0.98
72581362|NCT04620746|144692202|SUPERIORITY|||||||0.95|||||||Chi-squared|||||||0.95
72547535|NCT00368966|144624266|SUPERIORITY_OR_OTHER||Difference|1.5||||||95.0|-0.1|3.1||||||For serotype 7F, the difference in percentages between the two groups (13vPnC After Infant Series Dose 2 - 13vPnC After Infant Series Dose 3) was calculated||3.1|-0.1|
72547536|NCT00368966|144624266|SUPERIORITY_OR_OTHER||Difference|1.5||||||95.0|-0.4|3.4||||||For serotype 19A, the difference in percentages between the two groups (13vPnC After Infant Series Dose 2 - 13vPnC After Infant Series Dose 3) was calculated||3.4|-0.4|
72547537|NCT02907203|144624274|NON_INFERIORITY|Compared with the Performance Goal: 0.9mm|Mean Difference (Net)|-0.17|STANDARD_DEVIATION|0.98||0|TWO_SIDED|95.0|-0.5|0.152|||t-test, 2 sided|||||0.152|-0.5|0.000
72547538|NCT01816477|144624281|SUPERIORITY_OR_OTHER|||||||0.55|||||||t-test, 2 sided|||||||0.55
72547539|NCT01816477|144624282|SUPERIORITY_OR_OTHER|||||||0.0872|||||||Unequal Variance T-Test|||Comparison between the groups for day 1.||||0.0872
72547540|NCT01816477|144624282|SUPERIORITY_OR_OTHER|||||||0.6751|||||||Unequal Variance T-Test|||Comparison between groups for day 2.||||0.6751
72547541|NCT01816477|144624282|SUPERIORITY_OR_OTHER|||||||0.1203|||||||Unequal Variance T-Test|||Comparison between groups for day 3.||||0.1203
72547542|NCT01816477|144624282|SUPERIORITY_OR_OTHER|||||||0.3582|||||||Unequal Variance T-Test|||Comparison between groups for day 4.||||0.3582
72547543|NCT01816477|144624282|SUPERIORITY_OR_OTHER|||||||0.0625|||||||Unequal Variance T-Test|||Comparison between groups for day 5||||0.0625
72547544|NCT01816477|144624282|SUPERIORITY_OR_OTHER|||||||0.0484|||||||Unequal Variance T-Test|||Comparison between groups for day 6.||||0.0484
72547545|NCT01816477|144624283|SUPERIORITY_OR_OTHER|||||||0.6465|||||||Unequal Variance T-Test|||Comparison between the groups for day 1.||||0.6465
72547546|NCT01816477|144624283|SUPERIORITY_OR_OTHER|||||||0.9233|||||||Unequal Variance T-Test|||Comparison between groups for day 2.||||0.9233
72547547|NCT01816477|144624283|SUPERIORITY_OR_OTHER|||||||0.5788|||||||Unequal Variance T-Test|||Comparison between groups for day 3.||||0.5788
72547548|NCT01816477|144624283|SUPERIORITY_OR_OTHER|||||||0.1036|||||||Unequal Variance T-Test|||Comparison between the groups for day 4.||||0.1036
72547549|NCT01816477|144624283|SUPERIORITY_OR_OTHER|||||||0.5314|||||||Unequal Variance T-Test|||Comparison between groups for day 5.||||0.5314
72547550|NCT01816477|144624283|SUPERIORITY_OR_OTHER|||||||0.7166|||||||Unequal Variance T-Test|||Comparison between groups for day 6.||||0.7166
72547551|NCT00282256|144624291|NON_INFERIORITY_OR_EQUIVALENCE|If the 90% CI for AUC0-24 was found to lie entirely within the 80% to 125% range, then the exposure between the two formulations was considered to be equivalent.|Ratio of means|100.9|||||TWO_SIDED|90.0|90.8|112.1|||||Tacrolimus/tacrolimus MR ratio of natural log transformed means expressed as a percent.|The method of analysis of variance was used for the comparisons of AUC0-24. Exposure at steady state was used for tacrolimus (defined as Day 7) and for tacrolimus MR (defined as Day 14). The natural log (ln) was used to transform AUC0-24 prior to analysis and the results were transformed back to the original scale for the presentation of results.||112.1|90.8|
72547552|NCT00282256|144624293|NON_INFERIORITY_OR_EQUIVALENCE|If the 90% CI for Cmin was found to lie entirely within the 80% to 125% range, then the exposure between the two formulations was considered to be equivalent.|Ratio of means|91.8|||||TWO_SIDED|90.0|82.6|102.2|||||Tacrolimus/tacrolimus MR ratio of natural log transformed means expressed as a percent.|The method of analysis of variance was used for the comparisons of Cmin. Exposure at steady state was used for tacrolimus (defined as Day 7) and for tacrolimus MR (defined as Day 14). The natural log (ln) was used to transform Cmin prior to analysis and the results were transformed back to the original scale for the presentation of results.||102.2|82.6|
72547553|NCT00585780|144624326|OTHER|Expected outcome was that Prazosin will be better than placebo in reducing HDD% among High AW individuals but no differences by medication treatment in the Low AW individuals.|Odds Ratio (OR)|0.23||||0.016|TWO_SIDED|95.0|0.1|0.55||This is for the apriori hypothesis of significant AWX Treatment X Time effect.|Mixed Models Analysis|Simple effects were conducted to assess source of the interaction.||Intent-to-treat (ITT) analyses with baseline AW severity (mean-centered continuous CIWA-Ar scores) as a moderator of Time (Pre-Full Dose(FD): weeks 1-2; Post FD: weeks 3-12) were conducted with linear or generalized linear mixed effect (LME/GLME) piecewise growth models for continuous and binary outcomes. Control variables that were modeled in all analyses. As hypothesized, significant interactions were tested using AW median cut-offs for high and Low AW groups.||0.55|0.1|0.016
72581363|NCT03535740|144692206|OTHER|||||||0.0763||||||P-value was based on the comparison of the confirm ORR among the 90/180mg group against a fixed response rate of 20%.|Exact Binomial Test|The calculation was based on an exact binomial test with a total 1-sided alpha level of 0.025 at primary analysis.||||||0.0763
72547554|NCT00585780|144624327|OTHER|Expected outcome was that Prazosin will be better than placebo in reducing percent of drinking days (DD%) among High AW individuals but no differences by medication treatment in the Low AW individuals.|Odds Ratio (OR)|0.5||||0.002|TWO_SIDED|95.0|0.28|0.92||This is for apriori hypothesized significant AW X Treatment X Post-full dose time interaction effect.|Mixed Models Analysis|||Intent-to-treat (ITT) analyses with baseline AW severity (mean-centered continuous CIWA-Ar scores) as a moderator of Time (Pre-Full Dose(FD): weeks 1-2; Post FD: weeks 3-12) were conducted with linear or generalized linear mixed effect (LME/GLME) piecewise growth models for continuous and binary outcomes. Control variables that were modeled in all analyses. As hypothesized, significant interactions were tested using AW median cut-offs for high and Low AW groups.||0.92|0.28|0.002
72547555|NCT02566135|144624342|OTHER||Risk Ratio (RR)|1.4628||||0.5033|TWO_SIDED|95.0|0.6401|3.3428|||Chi-squared, Corrected|||Chi square test was applied to see weather there is a statistical significant difference between group I and group C for attempt for supraglottic airway insertion.||3.3428|0.6401|0.5033
72547556|NCT02566135|144624343|OTHER||Risk Ratio (RR)|0.8972|||>|0.05|TWO_SIDED|95.0|0.4858|1.6569|||Chi-squared, Corrected|||We had applied chi square to see the statistical significant difference between group I and group C for number of attempt for ventilating bougie insertion.||1.6569|0.4858|>0.05
72547557|NCT02566135|144624344|OTHER||||||>|0.05|||||||Chi-squared, Corrected|||||||>0.05
72547558|NCT02566135|144624345|OTHER|||||||0.44|||||||t-test, 2 sided|||Heart rate beats per minute measured at base line among the group I and group C.||||0.44
72547559|NCT02566135|144624345|OTHER|||||||0.58|||||||t-test, 2 sided|||Heart rate beats per minute is measured following Dexmedetomidine injection among the group I and group C.||||0.58
72547560|NCT02566135|144624345|OTHER|||||||0.16|||||||t-test, 2 sided|||Heart rate beats per minute measured following induction of anaesthesia among the group I and group C.||||0.16
72547561|NCT02566135|144624345|OTHER|||||||0.22|||||||t-test, 2 sided|||Heart rate beats per minute measured following supraglottic airway insertion among the group I and group C.||||0.22
72547562|NCT02566135|144624345|OTHER|||||||0.059|||||||t-test, 2 sided|||Heart rate beats per minute measured following ventilating bougie insertion among the group I and group C.||||0.059
72547563|NCT02566135|144624345|OTHER||||||>|0.33|||||||t-test, 2 sided|||Heart rate beats per minute measured at endotracheal intubation among the group I and group C.||||>0.33
72547564|NCT02566135|144624345|OTHER|||||||0.63|||||||t-test, 2 sided|||Heart rate beats per minute measured after 3 minute of ETT insertion among the group I and group C.||||0.63
72547565|NCT02566135|144624345|OTHER|||||||0.29|||||||t-test, 2 sided|||Heart rate beats per minute measured after 5 minute of ETT insertion among the group I and group C.||||0.29
72547566|NCT02566135|144624345|OTHER|||||||0.18|||||||t-test, 2 sided|||Heart rate beats per minute measured after 7 minute of ETT insertion among the group I and group C.||||0.18
72547567|NCT02566135|144624345|OTHER|||||||0.98|||||||t-test, 2 sided|||Heart rate beats per minute measured after 10 minute of ETT insertion among the group I and group C.||||0.98
72547568|NCT02566135|144624345|OTHER|||||||0.49|||||||t-test, 2 sided|||Heart rate beats per minute measured after 15 minute of ETT insertion among the group I and group C.||||0.49
72547569|NCT02566135|144624346|OTHER|||||||0.24|||||||t-test, 2 sided|||Systolic blood pressure measured and compared at base line between group I and group C.||||0.24
72581364|NCT05807828|144692224|SUPERIORITY||Median Difference (Final Values)|7.5|||<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||The median difference between the cup angle of the Control Group for Cup Training and the cup angle of VR Group for Cup Training.||||<0.05
72581365|NCT05807828|144692224|SUPERIORITY||Median Difference (Final Values)|291.5|||<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||The median difference between the stem angle of the Control Group for Stem Training and the stem angle of VR Group for Stem Training.||||<0.05
72412187|NCT02828111|144332389|OTHER|Pairwise comparison||||||0.157|||||||Fisher Exact|||This is the analysis of all four patidegib gel treatment groups combined compared with combined vehicle gel at Week 12.||||0.157
72547570|NCT02566135|144624346|OTHER|||||||0.11|||||||t-test, 2 sided|||Systolic blood pressure measured and compared following Dexmedetomidine injection between group I and group C.||||0.11
72547571|NCT02566135|144624346|OTHER|||||||0.07|||||||t-test, 2 sided|||Systolic blood pressure measured and compared following induction os anaesthesia between group I and group C.||||0.07
72581366|NCT05807828|144692225|SUPERIORITY||Mean Difference (Final Values)|54.5|STANDARD_DEVIATION|106.6|<|0.05|TWO_SIDED||||||paired t-test|||Each medical student carried out an implantation following VR training and without VR training. Therefore, there was a deviation (mean difference) between the predefined target and the implanted inclination for the cup or the stem version for the same medical student with VR training.||||<0.05
72581367|NCT05807828|144692225|SUPERIORITY||Mean Difference (Final Values)|89.8|STANDARD_DEVIATION|133.9|<|0.05|TWO_SIDED||||||paired t-test|||Each medical student carried out an implantation following VR training and without VR training. Therefore, there was a deviation (mean difference) between the predefined target and the implanted inclination for the cup or the stem version for the same medical student without VR training (control).||||<0.05
72581368|NCT05807828|144692226|SUPERIORITY||Median Difference (Final Values)|14.0|||<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Median difference between the time needed for cup implantation for Control cup group and the time needed for cup implantation for VR cup group||||<0.05
72581369|NCT05807828|144692226|SUPERIORITY||Median Difference (Final Values)|2.0|||<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Median difference between the time needed for stem implantation for Control stem group and the time needed for stem implantation for VR stem group||||<0.05
72581370|NCT02756611|144692229|SUPERIORITY||||||<|0.001|||||||Binomial test|||The null hypothesis stated that the CR rate for BCRi-naïve participants would be ≤ 6%, based on the CR rate reported for current therapies at the time the study was designed, with an alternative hypothesis that the CR rate would be \> 6%. If the p-value for this test was \< 0.025, the null hypothesis would be rejected.||||<0.001
72412188|NCT02667912|144332423|SUPERIORITY||Mean Difference (Final Values)|10.8||||0.045|TWO_SIDED|95.0|0.3|21.4||The a priori threshold for statistical significance \<0.05|t-test, 2 sided|||||21.4|0.3|0.045
72412189|NCT02667912|144332426|SUPERIORITY|||||||0.96|||||||t-test, 2 sided|||||||0.96
72412190|NCT02667912|144332427|OTHER|||||||0.203|||||||t-test, 2 sided|||||||0.203
72412191|NCT02667912|144332428|SUPERIORITY||Mean Difference (Final Values)|-4.3||||0.27|TWO_SIDED|95.0|-11.9|3.4|||t-test, 2 sided|||||3.4|-11.9|0.27
72412192|NCT02667912|144332429|SUPERIORITY||Mean Difference (Final Values)|7.8|STANDARD_ERROR_OF_MEAN|5.7||0.17|TWO_SIDED|95.0|-3.7|19.3||The a priori threshold for statistical significance p\<0.05|t-test, 2 sided|||||19.3|-3.7|0.17
72412193|NCT02667912|144332432|SUPERIORITY|||||||0.213|||||||t-test, 2 sided|||||||0.213
72412194|NCT02667912|144332433|SUPERIORITY|||||||0.041|||||||t-test, 2 sided|||||||0.041
72412195|NCT02667912|144332434|OTHER|||||||0.304|||||||t-test, 2 sided|||||||0.304
72547572|NCT02566135|144624346|OTHER|||||||0.85|||||||t-test, 2 sided|||Systolic blood pressure measured and compared following supraglottic airway insertion between group I and group C.||||0.85
72547573|NCT02566135|144624346|OTHER|||||||0.055|||||||t-test, 2 sided|||Systolic blood pressure measured and compared following ventilating bougie insertion between group I and group C.||||0.055
72547574|NCT02566135|144624346|OTHER|||||||0.71|||||||t-test, 2 sided|||Systolic blood pressure measured and compared at ETT insertion time between group I and group C.||||0.71
72547575|NCT02566135|144624346|OTHER|||||||0.2|||||||t-test, 2 sided|||Systolic blood pressure measured and compared 3 minutes after ETT insertion between group I and group C.||||0.20
72547576|NCT02566135|144624346|OTHER|||||||0.86|||||||t-test, 2 sided|||Systolic blood pressure measured and compared 5 minutes after ETT insertion between group I and group C.||||0.86
72547577|NCT02566135|144624346|OTHER|||||||0.68|||||||t-test, 2 sided|||Systolic blood pressure measured and compared 7 minutes after ETT insertion between group I and group C.||||0.68
72547578|NCT02566135|144624346|OTHER|||||||0.98|||||||t-test, 2 sided|||Systolic blood pressure measured and compared 10 minutes after ETT insertion between group I and group C.||||0.98
72547579|NCT02566135|144624346|OTHER|||||||0.49|||||||t-test, 2 sided|||Systolic blood pressure measured and compared 15 minutes after ETT insertion between group I and group C.||||0.49
72547580|NCT02566135|144624347|OTHER|||||||0.34|||||||t-test, 2 sided|||Diastolic blood pressure measured and compared at base line between group I and group C.||||0.34
72547581|NCT02566135|144624347|OTHER|||||||0.27|||||||t-test, 2 sided|||Diastolic blood pressure measured and compared following Dexmedetomidine injection between group I and group C.||||0.27
72581371|NCT02756611|144692240|SUPERIORITY||||||<|0.001|||||||Binomial test|||The null hypothesis stated that the CR rate for BCRi-naïve participants would be ≤ 6%, based on the CR rate reported for current therapies at the time the study was designed, with an alternative hypothesis that the CR rate would be \> 6%. If the p-value for this test was \< 0.025, the null hypothesis would be rejected.||||<0.001
72581372|NCT03787134|144692370|SUPERIORITY|||||||0.335|||||||t-test, 2 sided|||cued memory item reconstruction - test of reconstruction strength against 0||||.335
72581373|NCT03787134|144692370|SUPERIORITY|||||||0.016|||||||t-test, 2 sided|||uncued memory item reconstruction - test of reconstruction strength against 0||||.016
72412196|NCT02667912|144332435|SUPERIORITY|||||||0.49|||||||t-test, 2 sided|||||||0.49
72412197|NCT02667912|144332436|SUPERIORITY|||||||0.66|||||||t-test, 2 sided|||||||0.66
72412198|NCT02667912|144332437|SUPERIORITY|||||||0.59|||||||t-test, 2 sided|||||||0.59
72412199|NCT02667912|144332438|SUPERIORITY|||||||0.66|||||||t-test, 2 sided|||||||0.66
72412200|NCT02667912|144332439|SUPERIORITY|||||||0.04|||||||t-test, 2 sided|||||||0.04
72412201|NCT02667912|144332440|SUPERIORITY|||||||0.054|||||||t-test, 2 sided|||||||0.054
72412202|NCT02667912|144332441|SUPERIORITY|||||||0.204|||||||t-test, 2 sided|||||||0.204
72412203|NCT02667912|144332442|SUPERIORITY|||||||0.324|||||||t-test, 2 sided|||||||0.324
72412204|NCT02667912|144332443|SUPERIORITY|||||||0.217|||||||t-test, 2 sided|||||||0.217
72412205|NCT02667912|144332444|SUPERIORITY|||||||0.238|||||||t-test, 2 sided|||||||0.238
72412206|NCT02667912|144332445|SUPERIORITY|||||||0.969|||||||t-test, 2 sided|||||||0.969
72412207|NCT02667912|144332446|SUPERIORITY|||||||0.37|||||||t-test, 2 sided|||||||0.37
72412208|NCT00022516|144332453|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.84||||0.14|TWO_SIDED|95.0|0.6|1.06|||Log Rank|||||1.06|0.6|0.14
72412209|NCT00022516|144332454|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.87||||0.357|TWO_SIDED|95.0|0.65|1.17|||Log Rank|||||1.17|0.65|0.3570
72412210|NCT00022516|144332455|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.85||||0.3178|TWO_SIDED|95.0|0.62|1.17|||Log Rank|||||1.17|0.62|0.3178
72412211|NCT00022516|144332456|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.78||||0.06|TWO_SIDED|95.0|0.6|1.01|||Log Rank|||||1.01|0.6|0.06
72412212|NCT05799495|144332470|OTHER||LS Mean difference|-0.671|STANDARD_ERROR_OF_MEAN|0.3178||0.0181|TWO_SIDED|80.0|-1.08|-0.262|||Mixed Models Analysis|||||-0.262|-1.080|0.0181
72412213|NCT05799495|144332470|OTHER||LS Mean difference|-0.802|STANDARD_ERROR_OF_MEAN|0.3562||0.0127|TWO_SIDED|80.0|-1.26|-0.344|||Mixed Models Analysis|||||-0.344|-1.260|0.0127
72412214|NCT05799495|144332470|OTHER||LS Mean difference|-1.167|STANDARD_ERROR_OF_MEAN|0.264|<|0.0001|TWO_SIDED|80.0|-1.506|-0.827|||Mixed Models Analysis|||||-0.827|-1.506|<.0001
72412215|NCT05799495|144332471|OTHER||LS Mean difference|-0.608|STANDARD_ERROR_OF_MEAN|0.3402||0.0378|TWO_SIDED|80.0|-1.046|-0.17|||Mixed Models Analysis|||Day 3||-0.170|-1.046|0.0378
72412216|NCT05799495|144332471|OTHER||LS Mean difference|-1.304|STANDARD_ERROR_OF_MEAN|0.3718||0.0003|TWO_SIDED|80.0|-1.782|-0.826|||Mixed Models Analysis|||Day 3||-0.826|-1.782|0.0003
72412217|NCT05799495|144332471|OTHER||LS Mean difference|-1.148|STANDARD_ERROR_OF_MEAN|0.2803|<|0.0001|TWO_SIDED|80.0|-1.509|-0.788|||Mixed Models Analysis|||Day 3||-0.788|-1.509|<.0001
72412218|NCT05799495|144332471|OTHER||LS Mean difference|0.064|STANDARD_ERROR_OF_MEAN|0.2732||0.5931|TWO_SIDED|80.0|-0.287|0.416|||Mixed Models Analysis|||Day 10||0.416|-0.287|0.5931
72547582|NCT02566135|144624347|OTHER|||||||0.22|||||||t-test, 2 sided|||Diastolic blood pressure measured and compared following induction of anaesrthesia between group I and group C.||||0.22
72547583|NCT02566135|144624347|OTHER|||||||0.96|||||||t-test, 2 sided|||Diastolic blood pressure measured and compared following supraglottic airway insertion between group I and group C.||||0.96
72547584|NCT02566135|144624347|OTHER|||||||0.71|||||||t-test, 2 sided|||Diastolic blood pressure measured and compared following ventilating bougie insertion between group I and group C.||||0.71
72547585|NCT02566135|144624347|OTHER|||||||0.55|||||||t-test, 2 sided|||Diastolic blood pressure measured and compared the time of endotracheal tube insertion between group I and group C.||||0.55
72547586|NCT02566135|144624347|OTHER|||||||0.49|||||||t-test, 2 sided|||Diastolic blood pressure measured and compared 3 minutes after endotracheal tube insertion between group I and group C.||||0.49
72547587|NCT02566135|144624347|OTHER|||||||0.49|||||||t-test, 2 sided|||Diastolic blood pressure measured and compared 5 minutes after endotracheal tube insertion between group I and group C.||||0.49
72547588|NCT02566135|144624347|OTHER|||||||0.76|||||||t-test, 2 sided|||Diastolic blood pressure measured and compared 7 minutes after endotracheal tube insertion between group I and group C.||||0.76
72547589|NCT02566135|144624347|OTHER|||||||0.69|||||||t-test, 2 sided|||Diastolic blood pressure measured and compared 10 minutes after endotracheal tube insertion between group I and group C.||||0.69
72547590|NCT02566135|144624347|OTHER|||||||0.81|||||||t-test, 2 sided|||Diastolic blood pressure measured and compared 15 minutes after endotracheal tube insertion between group I and group C.||||0.81
72547591|NCT02566135|144624348|OTHER||||||<|0.0001|||||||t-test, 2 sided|||We had compared time of insertion for supraglottic airway between group I and group C.||||<0.0001
72547592|NCT02566135|144624349|OTHER||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
72547593|NCT02974153|144624351|SUPERIORITY||Mean Difference (Final Values)|-2.6|STANDARD_DEVIATION|6.15|<|0.0001|TWO_SIDED|95.0|-3.45|-1.74|||ANCOVA|||||-1.74|-3.45|<0.0001
72547594|NCT02974153|144624351|SUPERIORITY||Mean Difference (Final Values)|-2.03|STANDARD_DEVIATION|6.15|<|0.0001|TWO_SIDED|95.0|-2.88|-1.18|||ANCOVA|||||-1.18|-2.88|<0.0001
72547595|NCT02974153|144624352|SUPERIORITY||Mean Difference (Final Values)|18.1|||<|0.0001|TWO_SIDED|95.0|12.0|24.3|||Cochran-Mantel-Haenszel|||||24.3|12.0|<0.0001
72547596|NCT02974153|144624352|SUPERIORITY||Mean Difference (Final Values)|11.7||||0.0001|TWO_SIDED|95.0|5.8|17.5|||Cochran-Mantel-Haenszel|||||17.5|5.8|0.0001
72547597|NCT02974153|144624353|SUPERIORITY||Mean Difference (Final Values)|21.3|||<|0.0001|TWO_SIDED|95.0|15.0|27.6|||Cochran-Mantel-Haenszel|||||27.6|15.0|<0.0001
72547598|NCT02974153|144624353|SUPERIORITY||Mean Difference (Final Values)|15.3|||<|0.0001|TWO_SIDED|95.0|9.3|21.4|||Cochran-Mantel-Haenszel|||||21.4|9.3|<0.0001
72547599|NCT02974153|144624354|SUPERIORITY||Mean Difference (Final Values)|22.1|||<|0.0001|TWO_SIDED|95.0|14.9|29.2|||Cochran-Mantel-Haenszel|||||29.2|14.9|<0.0001
72547600|NCT02974153|144624354|SUPERIORITY||Mean Difference (Final Values)|18.2|||<|0.0001|TWO_SIDED|95.0|11.1|25.4|||Cochran-Mantel-Haenszel|||||25.4|11.1|<0.0001
72547601|NCT02974153|144624355|SUPERIORITY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
72547602|NCT02974153|144624355|SUPERIORITY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
72547603|NCT02974153|144624356|SUPERIORITY||Mean Difference (Final Values)|-1.38|||<|0.0001|TWO_SIDED|95.0|-1.88|-0.87|||ANCOVA|||||-0.87|-1.88|<0.0001
72547604|NCT02974153|144624356|SUPERIORITY||Mean Difference (Final Values)|-1.15|||<|0.0001|TWO_SIDED|95.0|-1.66|-0.65|||ANCOVA|||||-0.65|-1.66|<0.0001
72547605|NCT02974153|144624357|SUPERIORITY||Mean Difference (Final Values)|-2.88|||<|0.0001|TWO_SIDED|95.0|-3.91|-1.84|||ANCOVA|||||-1.84|-3.91|<0.0001
72547606|NCT02974153|144624357|SUPERIORITY||Mean Difference (Final Values)|-1.73||||0.001|TWO_SIDED|95.0|-2.76|-0.7|||ANCOVA|||||-0.70|-2.76|0.0010
72547607|NCT02974153|144624358|SUPERIORITY||Mean Difference (Final Values)|-11.0|||<|0.0001|TWO_SIDED|95.0|-14.22|-7.77|||Repeated Measures Model|||||-7.77|-14.22|<0.0001
72547608|NCT02974153|144624358|SUPERIORITY||Mean Difference (Final Values)|-8.26|||<|0.0001|TWO_SIDED|95.0|-11.48|-5.05|||Repeated Measures Model|||||-5.05|-11.48|<0.0001
72547609|NCT02277769|144624378|SUPERIORITY||difference in percentages|27.6|||<|0.0001|TWO_SIDED|95.0|20.46|34.69||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg q2w vs Placebo|Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity.||34.69|20.46|< 0.0001
72547610|NCT02277769|144624378|SUPERIORITY||difference in percentages|27.9|||<|0.0001|TWO_SIDED|95.0|20.87|34.99||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg qw vs Placebo|Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity.||34.99|20.87|< 0.0001
72547611|NCT02277769|144624379|SUPERIORITY||difference in percentages|32.3|||<|0.0001|TWO_SIDED|95.0|24.75|39.94||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg q2w vs Placebo|A hierarchical testing procedure was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.025 level. Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity.||39.94|24.75|< 0.0001
72412219|NCT05799495|144332471|OTHER||LS Mean difference|0.006|STANDARD_ERROR_OF_MEAN|0.2914||0.508|TWO_SIDED|80.0|-0.369|0.381|||Mixed Models Analysis|||Day 10||0.381|-0.369|0.5080
72412220|NCT05799495|144332471|OTHER||LS Mean difference|-0.214|STANDARD_ERROR_OF_MEAN|0.223||0.1692|TWO_SIDED|80.0|-0.501|0.073|||Mixed Models Analysis|||Day 10||0.073|-0.501|0.1692
72547612|NCT02277769|144624379|SUPERIORITY||difference in percentages|36.3|||<|0.0001|TWO_SIDED|95.0|28.69|43.81||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg qw vs Placebo|A hierarchical testing procedure was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.025 level. Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity.||43.81|28.69|< 0.0001
72412221|NCT05799495|144332471|OTHER||LS Mean difference|-0.239|STANDARD_ERROR_OF_MEAN|0.2004||0.1172|TWO_SIDED|80.0|-0.497|0.019|||Mixed Models Analysis|||Day 14||0.019|-0.497|0.1172
72547613|NCT02277769|144624380|SUPERIORITY||difference in percentages|26.5|||<|0.0001|TWO_SIDED|95.0|19.13|33.87||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg q2w vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||33.87|19.13|< 0.0001
72547614|NCT02277769|144624380|SUPERIORITY||difference in percentages|29.5|||<|0.0001|TWO_SIDED|95.0|22.11|36.95||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg qw vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||36.95|22.11|< 0.0001
72547615|NCT02277769|144624381|SUPERIORITY||difference in percentages|37.8|||<|0.0001|TWO_SIDED|95.0|30.03|45.6||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg q2w vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||45.60|30.03|< 0.0001
72547616|NCT02277769|144624381|SUPERIORITY||difference in percentages|36.3|||<|0.0001|TWO_SIDED|95.0|28.56|44.06||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg qw vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||44.06|28.56|< 0.0001
72547617|NCT02277769|144624382|SUPERIORITY||LS mean difference|-28.9|||<|0.0001|TWO_SIDED|95.0|-36.04|-21.83||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg q2w vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-21.83|-36.04|< 0.0001
72547618|NCT02277769|144624382|SUPERIORITY||Least square (LS) mean difference|-32.8|||<|0.0001|TWO_SIDED|95.0|-40.2|-25.49||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg qw vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-25.49|-40.20|< 0.0001
72547619|NCT02277769|144624383|SUPERIORITY||difference in percentages|16.3|||<|0.0001|TWO_SIDED|95.0|9.99|22.68||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg q2w vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||22.68|9.99|< 0.0001
72547620|NCT02277769|144624383|SUPERIORITY||difference in percentages|21.3|||<|0.0001|TWO_SIDED|95.0|14.66|27.93||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg qw vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||27.93|14.66|< 0.0001
72412222|NCT05799495|144332471|OTHER||LS Mean difference|-0.056|STANDARD_ERROR_OF_MEAN|0.2178||0.3979|TWO_SIDED|80.0|-0.337|0.224|||Mixed Models Analysis|||Day 14||0.224|-0.337|0.3979
72412223|NCT05799495|144332471|OTHER||LS Mean difference|-0.383|STANDARD_ERROR_OF_MEAN|0.1655||0.0109|TWO_SIDED|80.0|-0.595|-0.17|||Mixed Models Analysis|||Day 14||-0.170|-0.595|0.0109
72412224|NCT04177108|144332496|SUPERIORITY||Hazard Ratio (HR)|0.49||||0.0098||95.0|0.28|0.85|||Log Rank|||||0.85|0.28|0.0098
72412225|NCT04177108|144332496|SUPERIORITY||Hazard Ratio (HR)|0.72||||0.2396||95.0|0.42|1.25|||Log Rank|||||1.25|0.42|0.2396
72412226|NCT04177108|144332496|SUPERIORITY||Hazard Ratio (HR)|0.99||||0.9809||95.0|0.63|1.58|||Log Rank|||||1.58|0.63|0.9809
72412227|NCT04177108|144332497|SUPERIORITY||Hazard Ratio (HR)|1.17||||0.6805||95.0|0.55|2.51|||Log Rank|||||2.51|0.55|0.6805
72412228|NCT04177108|144332497|SUPERIORITY||Hazard Ratio (HR)|1.21||||0.6314||95.0|0.55|2.64|||Log Rank|||||2.64|0.55|0.6314
72547621|NCT02277769|144624384|SUPERIORITY||difference in percentages|9.8|||<|0.0001|TWO_SIDED|95.0|5.54|13.98||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg q2w vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||13.98|5.54|< 0.0001
72547622|NCT02277769|144624384|SUPERIORITY||difference in percentages|11.8|||<|0.0001|TWO_SIDED|95.0|7.31|16.32||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg qw vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||16.32|7.31|< 0.0001
72547623|NCT02277769|144624385|SUPERIORITY||LS mean difference|-2.1|||<|0.0001|TWO_SIDED|95.0|-2.605|-1.587||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg q2w vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-1.587|-2.605|< 0.0001
72547624|NCT02277769|144624385|SUPERIORITY||LS mean difference|-2.47|||<|0.0001|TWO_SIDED|95.0|-2.982|-1.957||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg qw vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-1.957|-2.982|< 0.0001
72412229|NCT04177108|144332497|SUPERIORITY||Hazard Ratio (HR)|1.04||||0.9164||95.0|0.52|2.06|||Log Rank|||||2.06|0.52|0.9164
72412230|NCT04102501|144332519|SUPERIORITY|||||||0.5858|||||||Mixed Models Analysis|||||||0.5858
72547625|NCT02277769|144624386|SUPERIORITY||LS mean difference|-36.2|||<|0.0001|TWO_SIDED|95.0|-43.46|-28.86|||ANCOVA||Dupilumab 300 mg q2w vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-28.86|-43.46|< 0.0001
72547626|NCT02277769|144624386|SUPERIORITY||LS mean difference|-38.2|||<|0.0001|TWO_SIDED|95.0|-45.55|-30.88||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg qw vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-30.88|-45.55|< 0.0001
72547627|NCT02277769|144624387|SUPERIORITY||difference in percentages|43.2|||<|0.0001|TWO_SIDED|95.0|35.12|51.29||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg q2w vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||51.29|35.12|< 0.0001
72547628|NCT02277769|144624387|SUPERIORITY||difference in percentages|39.1|||<|0.0001|TWO_SIDED|95.0|30.92|47.19||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg qw vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||47.19|30.92|< 0.0001
72547629|NCT02277769|144624388|SUPERIORITY||difference in percentages|22.8|||<|0.0001|TWO_SIDED|95.0|16.09|29.59||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg q2w vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||29.59|16.09|< 0.0001
72547630|NCT02277769|144624388|SUPERIORITY||difference in percentages|23.3|||<|0.0001|TWO_SIDED|95.0|16.63|30.05||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg qw vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||30.05|16.63|< 0.0001
72547631|NCT02277769|144624389|SUPERIORITY||LS mean difference|-17.99|||<|0.0001|TWO_SIDED|95.0|-22.062|-13.927||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg q2w vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-13.927|-22.062|< 0.0001
72547632|NCT02277769|144624389|SUPERIORITY||LS mean difference|-19.51|||<|0.0001|TWO_SIDED|95.0|-23.491|-15.529||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg qw vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-15.529|-23.491|< 0.0001
72547633|NCT02277769|144624390|SUPERIORITY||LS mean difference|-31.4|||<|0.0001|TWO_SIDED|95.0|-37.36|-25.4||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg q2w vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-25.40|-37.36|< 0.0001
72547634|NCT02277769|144624390|SUPERIORITY||LS mean difference|-33.8|||<|0.0001|TWO_SIDED|95.0|-39.75|-27.8||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg qw vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-27.80|-39.75|< 0.0001
72547635|NCT02277769|144624391|SUPERIORITY||LS mean difference|-5.7|||<|0.0001|TWO_SIDED|95.0|-6.86|-4.47||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg q2w vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-4.47|-6.86|< 0.0001
72547636|NCT02277769|144624391|SUPERIORITY||LS mean difference|-5.9|||<|0.0001|TWO_SIDED|95.0|-7.1|-4.72||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg qw vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-4.72|-7.10|< 0.0001
72412231|NCT04102501|144332520|SUPERIORITY|||||||0.8061|||||||Mixed Models Analysis|||||||0.8061
72412232|NCT04433767|144332584|OTHER||Slope|-1.22|STANDARD_ERROR_OF_MEAN|0.12|<|0.001|TWO_SIDED||||||Mixed Models Analysis|Adjusted for age and gender.||||||< 0.001
72412233|NCT04433767|144332586|OTHER||Intercept|0.18|STANDARD_ERROR_OF_MEAN|0.07||0.0127|TWO_SIDED|95.0|0.04|0.32|||Regression, Linear|Adjusted for age, sex, education, and baseline task performance.||||0.32|0.04|0.0127
72412234|NCT04433767|144332587|OTHER||Intercept|0.34|STANDARD_ERROR_OF_MEAN|0.08||0.0005|TWO_SIDED|95.0|0.17|0.51|||Regression, Linear|Adjusted for age, sex, education, and baseline task performance.||||0.51|0.17|0.0005
72547637|NCT02277769|144624392|SUPERIORITY||LS mean difference|-7.0|||<|0.0001|TWO_SIDED|95.0|-8.36|-5.57||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg q2w vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-5.57|-8.36|< 0.0001
72547638|NCT02277769|144624392|SUPERIORITY||LS mean difference|-8.0|||<|0.0001|TWO_SIDED|95.0|-9.36|-6.64||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg qw vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-6.64|-9.36|< 0.0001
72547639|NCT02277769|144624393|SUPERIORITY||LS mean difference|-4.2|||<|0.0001|TWO_SIDED|95.0|-5.34|-3.09||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg q2w vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-3.09|-5.34|< 0.0001
72547640|NCT02277769|144624393|SUPERIORITY||LS mean difference|-4.9|||<|0.0001|TWO_SIDED|95.0|-6.04|-3.81||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg qw vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-3.81|-6.04|< 0.0001
72547641|NCT02277769|144624394|SUPERIORITY||LS mean difference|-27.7|||<|0.0001|TWO_SIDED|95.0|-33.73|-21.7||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg q2w vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-21.70|-33.73|< 0.0001
72547642|NCT02277769|144624394|SUPERIORITY||LS mean difference|-28.9|||<|0.0001|TWO_SIDED|95.0|-35.03|-22.74||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg qw vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-22.74|-35.03|< 0.0001
72547643|NCT02277769|144624395|SUPERIORITY||LS mean difference|-17.7|||<|0.0001|TWO_SIDED|95.0|-21.96|-13.53||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg q2w vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-13.53|-21.96|< 0.0001
72547644|NCT02277769|144624395|SUPERIORITY||LS mean difference|-15.0|||<|0.0001|TWO_SIDED|95.0|-19.16|-10.78||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg qw vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-10.78|-19.16|< 0.0001
72547645|NCT01488578|144624408|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Chi-squared|||||||<0.001
72581374|NCT03281876|144692386|OTHER|Vaccine Efficacy is defined as 1 minus the risk ratio (Rvacc / Rcon) based on the number of moderate and severe AECOPD observed in 1 year , with Rvacc = average yearly incidence rate of AECOPD events per subject in the GSK3277511A Group and Rcon = average yearly incidence rate of AECOPD events per subject in the Control group. The objective is to be considered a success if the lower limit of the 87% CI is above 0%.|Other: Vaccine Efficacy rate|-2.26||||0.8157|TWO_SIDED|87.0|-18.27|11.58|||Negative Binomial regression|Negative Binomial model with arm, country, gold grade, history of exacerbation and age category as covariates and log time as offset variable||To assess efficacy of the investigational vaccine as compared to the placebo control with respect to the rate of moderate and severe AECOPDs||11.58|-18.27|0.8157
72547646|NCT01488578|144624411|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.032|TWO_SIDED||||||Chi-squared|||||||=0.032
72581375|NCT03281876|144692387|OTHER|Vaccine Efficacy is defined as 1 minus the risk ratio (Rvacc / Rcon) based on the number of moderate and severe AECOPD observed in 1 year , with Rvacc = average yearly incidence rate of AECOPD events per subject in the GSK3277511A Group and Rcon = average yearly incidence rate of AECOPD events per subject in the Control group.|Other: Vaccine Efficacy rate|-2.26||||0.8157|TWO_SIDED|95.0|-23.45|15.29|||Negative Binomial regression|Negative Binomial model with arm, country, gold grade, history of exacerbation and age category as covariates and log time as offset variable||To assess efficacy of the investigational vaccine as compared to the placebo control with respect to the rate of moderate and severe AECOPDs||15.29|-23.45|0.8157
72581376|NCT03281876|144692394|OTHER|Vaccine Efficacy is defined as 1 minus the risk ratio (Rvacc / Rcon) based on the number of moderate and severe AECOPD observed in 1 year , with Rvacc = average yearly incidence rate of AECOPD events per subject in the GSK3277511A Group and Rcon = average yearly incidence rate of AECOPD events per subject in the control group.|Vaccine efficacy rate|-2.72||||0.77|TWO_SIDED|95.0|-22.95|14.19|||Negative Binomial regression|||To assess efficacy of the investigational vaccine as compared to the placebo control with respect to the rate of AECOPDs of any severity- upto 12 months follow up period||14.19|-22.95|0.7700
72581377|NCT03281876|144692396|OTHER|The dependent variable is the time to first occurrence of the event. The reference is the Placebo.|Hazard Ratio (HR)|0.94||||0.5751|TWO_SIDED|95.0|0.758|1.166|||Regression, Cox|Analysis using Cox proportional hazard regression including history of exacerbation, study treatment, GOLD grade and age group as covariate.||Hazard rate for moderate or severe AECOPDs, one year follow-up starting 1 month post dose 2||1.166|0.758|0.5751
72581378|NCT03281876|144692397|OTHER|The dependent variable is the time to first occurrence of the event. The reference is the Placebo.|Hazard Ratio (HR)|0.934||||0.5194|TWO_SIDED|95.0|0.758|1.15|||Regression, Cox|Analysis using Cox proportional hazard regression including history of exacerbation, study treatment, GOLD grade and age group as covariate.||Hazard rate for any AECOPDs, one year follow-up starting 1 month post dose 2||1.15|0.758|0.5194
72581379|NCT03281876|144692398|OTHER|The dependent variable is the time to first occurrence of the event. The reference is the Placebo.|Hazard Ratio (HR)|1.05||||0.8581|TWO_SIDED|95.0|0.616|1.791|||Regression, Cox|Analysis using Cox proportional hazard regression including history of exacerbation, study treatment, GOLD grade and age group as covariate.||Hazard rate for mild AECOPDs, one year follow-up starting 1 month post dose 2||1.791|0.616|0.8581
72581380|NCT03281876|144692398|OTHER|The dependent variable is the time to first occurrence of the event. The reference is the Placebo.|Hazard Ratio (HR)|0.995||||0.9634|TWO_SIDED|95.0|0.792|1.249|||Regression, Cox|Analysis using Cox proportional hazard regression including history of exacerbation, study treatment, GOLD grade and age group as covariate.||Hazard rate for moderate AECOPDs, one year follow-up starting 1 month post dose 2||1.249|0.792|0.9634
72581381|NCT03281876|144692398|OTHER|The dependent variable is the time to first occurrence of the event. The reference is the Placebo.|Hazard Ratio (HR)|0.722||||0.1755|TWO_SIDED|95.0|0.45|1.157|||Regression, Cox|Analysis using Cox proportional hazard regression including history of exacerbation, study treatment, GOLD grade and age group as covariate.||Hazard rate for severe AECOPDs, one year follow-up starting 1 month post dose 2||1.157|0.45|0.1755
72547647|NCT01488578|144624412|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Chi-squared|||||||<0.001
72547648|NCT01488578|144624413|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Chi-squared|||||||<0.001
72547649|NCT01488578|144624414|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Chi-squared|||||||<0.001
72547650|NCT01488578|144624415|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||The Hosmer-Lemeshow Goodness-of-Fit TEST|||||||<0.001
72547651|NCT01488578|144624417|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.006|TWO_SIDED||||||Chi-squared|||||||=0.006
72547652|NCT01488578|144624418|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Chi-squared|||||||<0.001
72547653|NCT01488578|144624419|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.015|TWO_SIDED||||||Chi-squared|||||||=0.015
72547654|NCT01488578|144624420|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Chi-squared|||||||<0.001
72547655|NCT01488578|144624421|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Chi-squared|||||||<0.001
72412235|NCT04433767|144332588|OTHER||Intercept|0.19|STANDARD_ERROR_OF_MEAN|0.11||0.1027|TWO_SIDED|95.0|-0.04|0.42|||Regression, Linear|Adjusted for age, sex, education, and baseline task performance.||||0.42|-0.04|0.1027
72412236|NCT04433767|144332589|OTHER||Intercept|0.09|STANDARD_ERROR_OF_MEAN|0.13||0.4846|TWO_SIDED|95.0|-0.18|0.37|||Regression, Linear|Adjusted for age, sex, education, and baseline task performance.||||0.37|-0.18|0.4846
72412237|NCT04433767|144332590|OTHER||Intercept|9.04|STANDARD_ERROR_OF_MEAN|25.77||0.729|TWO_SIDED|95.0|-44.28|62.36|||Regression, Linear|Adjusted for age, sex, education, and baseline task performance.||||62.36|-44.28|0.7290
72412238|NCT04433767|144332591|OTHER||Intercept|-0.25|STANDARD_ERROR_OF_MEAN|2.43||0.9196|TWO_SIDED|95.0|-5.28|4.78|||Regression, Linear|Adjusted for age, sex, education, and baseline task performance.||||4.78|-5.28|0.9196
72412239|NCT04433767|144332592|OTHER||Slope|0.17|STANDARD_ERROR_OF_MEAN|0.08||0.033|TWO_SIDED|95.0|0.01|0.33|||Mixed Models Analysis|Adjusted for age and gender.||||0.33|0.01|0.033
72547656|NCT02308111|144624423|SUPERIORITY||Hazard Ratio, log|1.01||||0.954|TWO_SIDED|95.0|0.68|1.51||Log rank p-value and hazard ratio are based on stratified analyses, with the randomization stratification factors entered in the interactive web response system (IWRS) as strata|Log Rank|||||1.51|0.68|0.954
72547657|NCT02308111|144624424|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.304|TWO_SIDED|95.0|0.61|1.16||Log rank p-value and hazard ratio are based on stratified analyses, with the randomization stratification factors entered in the IWRS as strata.|Log Rank|||||1.16|0.61|0.304
72547658|NCT02308111|144624425|SUPERIORITY||Hazard Ratio (HR)|1.03||||0.898|TWO_SIDED|95.0|0.69|1.52||Log rank p-value and hazard ratio are based on stratified analyses, with the randomization stratification factors entered in the IWRS as strata.|Log Rank|||||1.52|0.69|0.898
72547659|NCT02308111|144624426|SUPERIORITY||Hazard Ratio (HR)|1.15||||0.594|TWO_SIDED|95.0|0.69|1.91||Log rank p-value and hazard ratio are based on stratified analyses, with the randomization stratification factors entered in the IWRS as strata.|Log Rank|||||1.91|0.69|0.594
72547660|NCT02308111|144624427|SUPERIORITY||Hazard Ratio (HR)|1.26||||0.568|TWO_SIDED|95.0|0.57|2.78||Log rank p-value and hazard ratio are based on stratified analyses, with the randomization stratification factors entered in the IWRS as strata.|Log Rank|||||2.78|0.57|0.568
72547661|NCT02308111|144624428|SUPERIORITY||Hazard Ratio (HR)|1.1||||0.769|TWO_SIDED|95.0|0.59|2.07||Gray's test p-value and hazard ratio are based on stratified analyses, with the randomization stratification factors entered in the interactive web response system (IWRS) as strata.|Gray's Test|||||2.07|0.59|0.769
72547662|NCT02308111|144624429|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.599|TWO_SIDED|95.0|0.42|1.67||Gray's test p-value and hazard ratio are based on stratified analyses, with the randomization stratification factors entered in the IWRS as strata.|Gray's Test|||||1.67|0.42|0.599
72547663|NCT02308111|144624430|SUPERIORITY||Hazard Ratio (HR)|0.78||||0.745|TWO_SIDED|95.0|0.18|3.43||Gray's test p-value and hazard ratio are based on stratified analyses, with the randomization stratification factors entered in the IWRS as strata.|Gray's Test|||||3.43|0.18|0.745
72412240|NCT04433767|144332593|OTHER||Slope|0.18|STANDARD_ERROR_OF_MEAN|0.09||0.041|TWO_SIDED|95.0|0.01|0.35|||Mixed Models Analysis|Adjusted for age and gender.||||0.35|0.01|0.041
72412241|NCT04433767|144332594|OTHER||Slope|-11.13|STANDARD_ERROR_OF_MEAN|3.36||0.001|TWO_SIDED|95.0|-17.81|-4.45|||Mixed Models Analysis|Adjusted for age and gender.||||-4.45|-17.81|0.001
72412242|NCT04433767|144332595|OTHER||Slope|-12.64|STANDARD_ERROR_OF_MEAN|3.68||0.001|TWO_SIDED|95.0|-19.94|-5.33|||Mixed Models Analysis|Adjusted for age and gender.||||-5.33|-19.94|0.001
72412243|NCT04433767|144332596|OTHER||Slope|-0.74|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|-1.15|-0.32|||Mixed Models Analysis|||||-0.32|-1.15|<0.001
72412244|NCT04433767|144332597|OTHER||Slope|-0.63|STANDARD_ERROR_OF_MEAN|0.14||0.001|TWO_SIDED|95.0|-0.92|-0.34|||Mixed Models Analysis|Adjusted for age and gender.||||-0.34|-0.92|0.001
72547664|NCT02308111|144624431|SUPERIORITY||Hazard Ratio (HR)|0.78||||0.437|TWO_SIDED|95.0|0.43|1.44||Gray's test p-value and hazard ratio are based on stratified analyses, with the randomization stratification factors entered in the IWRS as strata.|Gray's Test|||||1.44|0.43|0.437
72547665|NCT02308111|144624432|SUPERIORITY||Hazard Ratio (HR)|0.91||||0.838|TWO_SIDED|95.0|0.37|2.24||Gray's test p-value and hazard ratio are based on stratified analyses, with the randomization stratification factors entered in the IWRS as strata.|Gray's Test|||||2.24|0.37|0.838
72547666|NCT02308111|144624433|SUPERIORITY||Hazard Ratio (HR)|1.02||||0.98|TWO_SIDED|95.0|0.26|4.04||Gray's test p-value and hazard ratio are based on stratified analyses, with the randomization stratification factors entered in the IWRS as strata.|Gray's Test|||||4.04|0.26|0.980
72547667|NCT02308111|144624434|SUPERIORITY||Hazard Ratio (HR)|1.03||||0.933|TWO_SIDED|95.0|0.58|1.83||Gray's test p-value and hazard ratio are based on stratified analyses, with the randomization stratification factors entered in the IWRS as strata.|Gray's Test|||||1.83|0.58|0.933
72547668|NCT02308111|144624435|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.468|TWO_SIDED|95.0|0.53|1.34||Gray's test p-value and hazard ratio are based on stratified analyses, with the randomization stratification factors entered in the IWRS as strata.|Gray's Test|||||1.34|0.53|0.468
72547669|NCT02308111|144624436|SUPERIORITY||Hazard Ratio (HR)|0.43||||0.178|TWO_SIDED|95.0|0.13|1.41||Gray's test p-value and hazard ratio are based on stratified analyses, with the randomization stratification factors entered in the IWRS as strata.|Gray's Test|||||1.41|0.13|0.178
72547670|NCT02308111|144624436|SUPERIORITY||Hazard Ratio (HR)|0.43||||0.19|TWO_SIDED|95.0|0.13|1.41|||Cochran-Mantel-Haenszel|||||1.41|0.13|0.190
72547671|NCT02308111|144624437|SUPERIORITY||Hazard Ratio (HR)|0.43||||0.443|TWO_SIDED|95.0|0.05|3.54||Gray's test p-value and hazard ratio are based on stratified analyses, with the randomization stratification factors entered in the IWRS as strata.|Gray's Test|||||3.54|0.05|0.443
72412245|NCT04433767|144332598|OTHER||Slope|-0.41|STANDARD_ERROR_OF_MEAN|0.12|<|0.001|TWO_SIDED|95.0|-0.65|-0.18|||Mixed Models Analysis|Adjusted for age and gender.||||-0.18|-0.65|<0.001
72547672|NCT00455533|144624567|SUPERIORITY_OR_OTHER|||||||0.8921||95.0|||||Fisher Exact|||||||0.8921
72547673|NCT00455533|144624567|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.96||||0.8966|TWO_SIDED|90.0|0.6|1.55|||Cochran-Mantel-Haenszel|||||1.55|0.60|0.8966
72547674|NCT00455533|144624567|SUPERIORITY_OR_OTHER||difference in pCR|-0.6|||||TWO_SIDED|95.0|-7.9|6.7|||||The difference in pCR rates and the confidence interval computed using the method of DerSimonian and Laird stratified by tumor size at baseline, estrogen receptor status, and clinical response to AC.|||6.7|-7.9|
72547675|NCT00455533|144624570|SUPERIORITY_OR_OTHER|||||||0.6186||95.0|||||Fisher Exact|||||||0.6186
72547676|NCT00455533|144624570|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.86||||0.5806|TWO_SIDED|90.0|0.56|1.34|||Cochran-Mantel-Haenszel|||||1.34|0.56|0.5806
72547677|NCT00455533|144624570|SUPERIORITY_OR_OTHER||difference|-2.5|||||TWO_SIDED|90.0|-11.0|6.0|||||The difference in pCR/RCB-I rates and the confidence interval computed using the method of DerSimonian and Laird stratified by tumor size at baseline, estrogen receptor status, and clinical response to AC.|||6.0|-11|
72547678|NCT00455533|144624571|SUPERIORITY_OR_OTHER|||||||0.4115||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment: ER) and the reduced model: (PCR \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||ABCB1 (209993\_at)||||0.4115
72547679|NCT00455533|144624571|SUPERIORITY_OR_OTHER|||||||0.1629||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment) and the reduced model: (PCR \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||ABCB1 209993\_at||||0.1629
72547680|NCT00455533|144624571|SUPERIORITY_OR_OTHER|||||||0.5074||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||ABCB1 209993\_at||||0.5074
72547681|NCT00455533|144624571|SUPERIORITY_OR_OTHER|||||||0.553||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment: ER) and the reduced model: (PCR \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||ABCB1 /// ABCB4 209994\_s\_at||||0.5530
72547682|NCT00455533|144624571|SUPERIORITY_OR_OTHER|||||||0.1845||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment) and the reduced model: (PCR \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||ABCB1 /// ABCB4 209994\_s\_at||||0.1845
72547683|NCT00455533|144624571|SUPERIORITY_OR_OTHER|||||||0.3538||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||ABCB1 /// ABCB4 209994\_s\_at||||0.3538
72547684|NCT00455533|144624571|SUPERIORITY_OR_OTHER|||||||0.9751||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment: ER) and the reduced model: (PCR \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||BRCA1 211851\_x\_at||||0.9751
72547685|NCT00455533|144624571|SUPERIORITY_OR_OTHER|||||||0.8874||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment) and the reduced model: (PCR \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||BRCA1 211851\_x\_at||||0.8874
72547686|NCT00455533|144624571|SUPERIORITY_OR_OTHER|||||||0.6907||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||BRCA1 211851\_x\_at||||0.6907
72547687|NCT00455533|144624571|SUPERIORITY_OR_OTHER|||||||0.8052||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment: ER) and the reduced model: (PCR \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||BRCA1 204531\_s\_at||||0.8052
72547688|NCT00455533|144624571|SUPERIORITY_OR_OTHER|||||||0.5031||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment) and the reduced model: (PCR \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||BRCA1 204531\_s\_at||||0.5031
72547689|NCT00455533|144624571|SUPERIORITY_OR_OTHER|||||||0.7588||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||BRCA1 204531\_s\_at||||0.7588
72547690|NCT00455533|144624571|SUPERIORITY_OR_OTHER|||||||0.1542||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment: ER) and the reduced model: (PCR \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||ERCC1 203719\_at||||0.1542
72547691|NCT00455533|144624571|SUPERIORITY_OR_OTHER|||||||0.0235||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment) and the reduced model: (PCR \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||ERCC1 203719\_at||||0.0235
72547692|NCT00455533|144624571|SUPERIORITY_OR_OTHER|||||||0.3612||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||ERCC1 203719\_at||||0.3612
72547693|NCT00455533|144624571|SUPERIORITY_OR_OTHER|||||||0.184||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment: ER) and the reduced model: (PCR \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||ERCC1 203720\_s\_at||||0.1840
72547694|NCT00455533|144624571|SUPERIORITY_OR_OTHER|||||||0.0942||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment) and the reduced model: (PCR \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||ERCC1 203720\_s\_at||||0.0942
72547695|NCT00455533|144624571|SUPERIORITY_OR_OTHER|||||||0.5327||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||ERCC1 203720\_s\_at||||0.5327
72547696|NCT00455533|144624571|SUPERIORITY_OR_OTHER|||||||0.8847||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment: ER) and the reduced model: (PCR \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||GTSE1 204315\_s\_at||||0.8847
72547697|NCT00455533|144624571|SUPERIORITY_OR_OTHER|||||||0.8947||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment) and the reduced model: (PCR \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||GTSE1 204315\_s\_at||||0.8947
72547698|NCT00455533|144624571|SUPERIORITY_OR_OTHER|||||||0.4085||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||GTSE1 204315\_s\_at||||0.4085
72547699|NCT00455533|144624571|SUPERIORITY_OR_OTHER|||||||0.1119||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment: ER) and the reduced model: (PCR \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||GTSE1 204317\_at||||0.1119
72547700|NCT00455533|144624571|SUPERIORITY_OR_OTHER|||||||0.025||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment) and the reduced model: (PCR \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||GTSE1 204317\_at||||0.0250
72547701|NCT00455533|144624571|SUPERIORITY_OR_OTHER|||||||0.3569||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||GTSE1 204317\_at||||0.3569
72547702|NCT00455533|144624571|SUPERIORITY_OR_OTHER|||||||0.4103||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment: ER) and the reduced model: (PCR \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||GTSE1 215942\_s\_at||||0.4103
72547703|NCT00455533|144624571|SUPERIORITY_OR_OTHER|||||||0.149||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment) and the reduced model: (PCR \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||GTSE1 215942\_s\_at||||0.1490
72547704|NCT00455533|144624571|SUPERIORITY_OR_OTHER|||||||0.559||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||GTSE1 215942\_s\_at||||0.5590
72547705|NCT00455533|144624571|SUPERIORITY_OR_OTHER|||||||0.4796||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment: ER) and the reduced model: (PCR \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||GTSE1 204318\_s\_at||||0.4796
72547706|NCT00455533|144624571|SUPERIORITY_OR_OTHER|||||||0.2794||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment) and the reduced model: (PCR \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||GTSE1 204318\_s\_at||||0.2794
72547707|NCT00455533|144624571|SUPERIORITY_OR_OTHER|||||||0.1646||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||GTSE1 204318\_s\_at||||0.1646
72547708|NCT00455533|144624571|SUPERIORITY_OR_OTHER|||||||0.0782||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment: ER) and the reduced model: (PCR \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||GTSE1 211040\_x\_at||||0.0782
72547709|NCT00455533|144624571|SUPERIORITY_OR_OTHER|||||||0.1407||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment) and the reduced model: (PCR \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||GTSE1 211040\_x\_at||||0.1407
72547710|NCT00455533|144624571|SUPERIORITY_OR_OTHER|||||||0.2369||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR \~ Biomarker : Treatment : ER|Regression, Logistic|p-value not adjusted for multiple comparison||GTSE1 211040\_x\_at||||0.2369
72547711|NCT00455533|144624571|SUPERIORITY_OR_OTHER|||||||0.7756||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment: ER) and the reduced model: (PCR \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||KLK10 209792\_s\_at||||0.7756
72547712|NCT00455533|144624571|SUPERIORITY_OR_OTHER|||||||0.2623||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment) and the reduced model: (PCR \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||KLK10 209792\_s\_at||||0.2623
72547713|NCT00455533|144624571|SUPERIORITY_OR_OTHER|||||||0.3147||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||KLK10 209792\_s\_at||||0.3147
72547714|NCT00455533|144624571|SUPERIORITY_OR_OTHER|||||||0.2885||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment: ER) and the reduced model: (PCR \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||KLK10 215808\_at||||0.2885
72547715|NCT00455533|144624571|SUPERIORITY_OR_OTHER|||||||0.7187||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment) and the reduced model: (PCR \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||KLK10 215808\_at||||0.7187
72547716|NCT00455533|144624571|SUPERIORITY_OR_OTHER|||||||0.6017||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||KLK10 215808\_at||||0.6017
72547717|NCT00455533|144624571|SUPERIORITY_OR_OTHER|||||||0.45||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment: ER) and the reduced model: (PCR \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||KLK5 222242\_s\_at||||0.4500
72547718|NCT00455533|144624571|SUPERIORITY_OR_OTHER|||||||0.0952||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment) and the reduced model: (PCR \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||KLK5 222242\_s\_at||||0.0952
72547719|NCT00455533|144624571|SUPERIORITY_OR_OTHER|||||||0.7069||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||KLK5 222242\_s\_at||||0.7069
72547720|NCT00455533|144624571|SUPERIORITY_OR_OTHER|||||||0.4767||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment: ER) and the reduced model: (PCR \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||KLK6 204733\_at||||0.4767
72547721|NCT00455533|144624571|SUPERIORITY_OR_OTHER|||||||0.6191||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment) and the reduced model: (PCR \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||KLK6 204733\_at||||0.6191
72547722|NCT00455533|144624571|SUPERIORITY_OR_OTHER|||||||0.5276||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||KLK6 204733\_at||||0.5276
72547723|NCT00455533|144624571|SUPERIORITY_OR_OTHER|||||||0.3323||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment: ER) and the reduced model: (PCR \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||RRM1 201476\_s\_at||||0.3323
72547724|NCT00455533|144624571|SUPERIORITY_OR_OTHER|||||||0.1025||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment) and the reduced model: (PCR \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||RRM1 201476\_s\_at||||0.1025
72547725|NCT00455533|144624571|SUPERIORITY_OR_OTHER|||||||0.1715||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||RRM1 201476\_s\_at||||0.1715
72547726|NCT00455533|144624571|SUPERIORITY_OR_OTHER|||||||0.107||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment: ER) and the reduced model: (PCR \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||RRM1 201477\_s\_at||||0.1070
72547727|NCT00455533|144624571|SUPERIORITY_OR_OTHER|||||||0.2751||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment) and the reduced model: (PCR \~ Biomarker + Treatment|Regression, Logistic|p-value not adjusted for multiple comparison||RRM1 201477\_s\_at||||0.2751
72547728|NCT00455533|144624571|SUPERIORITY_OR_OTHER|||||||0.0276||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||RRM1 201477\_s\_at||||0.0276
72547729|NCT00455533|144624571|SUPERIORITY_OR_OTHER|||||||0.1689||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment: ER) and the reduced model: (PCR \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB 211714\_x\_at||||0.1689
72547730|NCT00455533|144624571|SUPERIORITY_OR_OTHER|||||||0.0769||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment) and the reduced model: (PCR \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB 211714\_x\_at||||0.0769
72547731|NCT00455533|144624571|SUPERIORITY_OR_OTHER|||||||0.1058||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB 211714\_x\_at||||0.1058
72547732|NCT00455533|144624571|SUPERIORITY_OR_OTHER|||||||0.6406||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment: ER) and the reduced model: (PCR \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB 212320\_at||||0.6406
72547733|NCT00455533|144624571|SUPERIORITY_OR_OTHER|||||||0.1733||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment) and the reduced model: (PCR \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB 212320\_at||||0.1733
72547734|NCT00455533|144624571|SUPERIORITY_OR_OTHER|||||||0.2631||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB 212320\_at||||0.2631
72547735|NCT00455533|144624571|SUPERIORITY_OR_OTHER|||||||0.217||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment: ER) and the reduced model: (PCR \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB 209026\_x\_at||||0.2170
72547736|NCT00455533|144624571|SUPERIORITY_OR_OTHER|||||||0.0868||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment) and the reduced model: (PCR \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB 209026\_x\_at||||0.0868
72547737|NCT00455533|144624571|SUPERIORITY_OR_OTHER|||||||0.1117||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB 209026\_x\_at||||0.1117
72547738|NCT00455533|144624571|SUPERIORITY_OR_OTHER|||||||0.4943||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment: ER) and the reduced model: (PCR \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB1 (208601\_s\_at)||||0.4943
72547739|NCT00455533|144624571|SUPERIORITY_OR_OTHER|||||||0.519||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment) and the reduced model: (PCR \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB1 208601\_s\_at||||0.5190
72547740|NCT00455533|144624571|SUPERIORITY_OR_OTHER|||||||0.735||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB1 208601\_s\_at||||0.7350
72547741|NCT00455533|144624571|SUPERIORITY_OR_OTHER|||||||0.382||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment: ER) and the reduced model: (PCR \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB2A 204141\_at||||0.3820
72547742|NCT00455533|144624571|SUPERIORITY_OR_OTHER|||||||0.929||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment) and the reduced model: (PCR \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB2A 204141\_at||||0.9290
72547743|NCT00455533|144624571|SUPERIORITY_OR_OTHER|||||||0.0699||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB2A 204141\_at||||0.0699
72547744|NCT00455533|144624571|SUPERIORITY_OR_OTHER|||||||0.3515||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment: ER) and the reduced model: (PCR \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB2A /// TUBB2B 209372\_x\_at||||0.3515
72547745|NCT00455533|144624571|SUPERIORITY_OR_OTHER|||||||0.2128||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment) and the reduced model: (PCR \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB2A /// TUBB2B 209372\_x\_at||||0.2128
72547746|NCT00455533|144624571|SUPERIORITY_OR_OTHER|||||||0.1275||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB2A /// TUBB2B 209372\_x\_at||||0.1275
72581382|NCT03281876|144692405|OTHER|The dependent variable is the time to first occurrence of the event. The reference is the Placebo.|Hazard Ratio (HR)|1.038||||0.9463|TWO_SIDED|95.0|0.73|1.477|||Regression, Cox|Analysis using Cox proportional hazard regression including history of exacerbation, study treatment, GOLD grade and age group as covariate.||Hazard rate for moderate or severe NTHi-associated and/or Mcat-associated AECOPDs, one year follow-up starting 1 month post dose 2||1.477|0.73|0.9463
72581383|NCT03281876|144692406|OTHER|The dependent variable is the time to first occurrence of the event. The reference is the Placebo.|Hazard Ratio (HR)|1.093||||0.6042|TWO_SIDED|95.0|0.782|1.528|||Regression, Cox|Analysis using Cox proportional hazard regression including history of exacerbation, study treatment, GOLD grade and age group as covariate.||Hazard rate for any NTHi-associated and/or Mcat-associated AECOPDs, one year follow-up starting 1 month post dose 2||1.528|0.782|0.6042
72581384|NCT03281876|144692407|OTHER|The dependent variable is the time to first occurrence of the event. The reference is the Placebo.|Hazard Ratio (HR)|2.243||||0.0777|TWO_SIDED|95.0|0.914|5.504|||Regression, Cox|Analysis using Cox proportional hazard regression including history of exacerbation, study treatment, GOLD grade and age group as covariate.||Hazard rate for mild NTHi-associated and/or Mcat-associated AECOPDs, one year follow-up starting 1 month post dose 2||5.504|0.914|0.0777
72581385|NCT03281876|144692407|OTHER|The dependent variable is the time to first occurrence of the event. The reference is the Placebo.|Hazard Ratio (HR)|1.021||||0.9121|TWO_SIDED|95.0|0.71|1.467|||Regression, Cox|Analysis using Cox proportional hazard regression including history of exacerbation, study treatment, GOLD grade and age group as covariate.||Hazard rate for moderate NTHi-associated and/or Mcat-associated AECOPDs, one year follow-up starting 1 month post dose 2||1.467|0.71|0.9121
72581386|NCT03281876|144692407|OTHER|The dependent variable is the time to first occurrence of the event. The reference is the Placebo.|Hazard Ratio (HR)|1.12||||0.8737|TWO_SIDED|95.0|0.278|4.502|||Regression, Cox|Analysis using Cox proportional hazard regression including history of exacerbation, study treatment, GOLD grade and age group as covariate.||Hazard rate for severe NTHi-associated and/or Mcat-associated AECOPDs, one year follow-up starting 1 month post dose 2||4.502|0.278|0.8737
72581387|NCT02208089|144692419|SUPERIORITY|||||||0.03|||||||t-test, 2 sided|||Null hypothesis = TransPRK produced no gains in vision over and above those produced by CXL only||||0.03
72581388|NCT02208089|144692420|SUPERIORITY|||||||0.005|||||||Chi-squared|||Null hypothesis = an equal proportion of patients in both study arms have clinically significant visual gains||||0.005
72581389|NCT02208089|144692421|NON_INFERIORITY|Non-inferiority = no significant difference between rates of clinically significant visual loss between groups at the p≤0.05 level||||||0.13|||||||Chi-squared|||null hypothesis = rates of clinically significant visual loss are equal for TransPRKCXL and CXL only||||0.13
72547747|NCT00455533|144624571|SUPERIORITY_OR_OTHER|||||||0.2158||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment: ER) and the reduced model: (PCR \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB2B 214023\_x\_at||||0.2158
72547748|NCT00455533|144624571|SUPERIORITY_OR_OTHER|||||||0.0266||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment) and the reduced model: (PCR \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB2B 214023\_x\_at||||0.0266
72547749|NCT00455533|144624571|SUPERIORITY_OR_OTHER|||||||0.3636||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB2B 214023\_x\_at||||0.3636
72547750|NCT00455533|144624571|SUPERIORITY_OR_OTHER|||||||0.9479||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment: ER) and the reduced model: (PCR \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB2C 208977\_x\_at||||0.9479
72547751|NCT00455533|144624571|SUPERIORITY_OR_OTHER|||||||0.3753||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment) and the reduced model: (PCR \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB2C 208977\_x\_at||||0.3753
72412246|NCT04433767|144332599|OTHER||Slope|-0.47|STANDARD_ERROR_OF_MEAN|0.35||0.183|TWO_SIDED|95.0|-1.17|0.23|||Mixed Models Analysis|Adjusted for age and gender.||||0.23|-1.17|0.183
72412247|NCT04433767|144332600|OTHER||Slope|-0.3|STANDARD_ERROR_OF_MEAN|0.22||0.17|TWO_SIDED|95.0|-0.74|0.13|||Mixed Models Analysis|Analyses adjusted for age and gender.||||0.13|-0.74|0.170
72581390|NCT00683657|144692424|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.8|STANDARD_ERROR_OF_MEAN|4.16||0.0001|TWO_SIDED|95.0|-25.1|-8.5||Between-group comparisons significant at alpha = 0.05, significance testing based on hierarchical testing. Primary and secondary endpoints are presented in order of testing.|ANCOVA|ANCOVA Model: post - pre = pre treatment|Mean difference = adjusted mean change for saxagliptin 5 mg + Metformin - adjusted mean change for Placebo + Metformin.|With 39 subjects per treatment group, there was a 93% power for the primary endpoint to detect a difference in 24-hour mean weighted glucose of 16 mg/dL between saxagliptin and placebo, assuming a standard deviation of 20 mg/dL. Assuming a dropout rate of 15%, a total of 92 subjects (46 subjects per treatment arm) needed to be randomized.||-8.5|-25.1|0.0001
72581391|NCT00683657|144692425|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-30.2|STANDARD_ERROR_OF_MEAN|7.1|<|0.0001|TWO_SIDED|95.0|-44.4|-16.1||Between-group comparisons significant at alpha = 0.05, significance testing based on hierarchical testing. Primary and secondary endpoints are presented in order of testing.|ANCOVA|ANCOVA model: post - pre = pretreatment|Mean difference = adjusted mean change for saxagliptin 5 mg + Metformin - adjusted mean change for Placebo + Metformin|With 39 subjects per treatment group, there was a 93% power for the primary endpoint to detect a difference in 24-hour mean weighted glucose of 16 mg/dL between saxagliptin and placebo, assuming a standard deviation of 20 mg/dL. Assuming a dropout rate of 15%, a total of 92 subjects (46 subjects per treatment arm) needed to be randomized.||-16.1|-44.4|<0.0001
72581392|NCT00683657|144692426|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-35.4|STANDARD_ERROR_OF_MEAN|10.41||0.001|TWO_SIDED|95.0|-56.2|-14.7||Between-group comparisons significant at alpha = 0.05, significance testing based on hierarchical testing. Primary and secondary endpoints are presented in order of testing.|ANCOVA|ANCOVA model: post - pre = pretreatment|Mean difference = adjusted mean change for saxagliptin 5 mg + Metformin - adjusted mean change for Placebo + Metformin|With 39 subjects per treatment group, there was a 93% power for the primary endpoint to detect a difference in 24-hour mean weighted glucose of 16 mg/dL between saxagliptin and placebo, assuming a standard deviation of 20 mg/dL. Assuming a dropout rate of 15%, a total of 92 subjects (46 subjects per treatment arm) needed to be randomized.||-14.7|-56.2|0.0010
72581393|NCT00683657|144692427|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-18.7|STANDARD_ERROR_OF_MEAN|4.22|<|0.0001|TWO_SIDED|95.0|-27.1|-10.3||Between-group comparisons significant at alpha = 0.05, significance testing based on hierarchical testing. Primary and secondary endpoints are presented in order of testing.|ANCOVA|ANCOVA Model: post - pre = pretreatment|Mean difference = adjusted mean change for saxagliptin 5 mg + Metformin - adjusted mean change for Placebo + Metformin|With 39 subjects per treatment group, there was a 93% power for the primary endpoint to detect a difference in 24-hour mean weighted glucose of 16 mg/dL between saxagliptin and placebo, assuming a standard deviation of 20 mg/dL. Assuming a dropout rate of 15%, a total of 92 subjects (46 subjects per treatment arm) needed to be randomized.||-10.3|-27.1|<0.0001
72581394|NCT00683657|144692428|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.3|STANDARD_ERROR_OF_MEAN|4.0||0.0002|TWO_SIDED|95.0|-23.3|-7.4||Between-group comparisons significant at alpha = 0.05, significance testing based on hierarchical testing. Primary and secondary endpoints are presented in order of testing.|ANCOVA|ANCOVA Model: post - pre = pretreatment|Mean difference = adjusted mean change for saxagliptin 5 mg + Metformin - adjusted mean change for Placebo + Metformin|With 39 subjects per treatment group, there was a 93% power for the primary endpoint to detect a difference in 24-hour mean weighted glucose of 16 mg/dL between saxagliptin and placebo, assuming a standard deviation of 20 mg/dL. Assuming a dropout rate of 15%, a total of 92 subjects (46 subjects per treatment arm) needed to be randomized.||-7.4|-23.3|0.0002
72581395|NCT01998841|144692462|SUPERIORITY||Difference in Annualized Rate of Change|0.33|STANDARD_ERROR_OF_MEAN|0.41||0.43|TWO_SIDED|95.0|-0.48|1.13|||RCRM|||Analysis was based on random coefficient regression model (RCRM) using unstructured covariance matrix: API Composite Endpoint=Treatment \* Analysis Year + interactive voice or Web-based response system (IxRS) defined Age Group + IxRS defined Education History + IxRS defined apolipoprotein E4 (APOE4) Carrier Status + IxRS defined CDR Global Score.||1.13|-0.48|0.43
72581396|NCT01998841|144692463|SUPERIORITY||Difference in Annualized Rate of Change|0.008|STANDARD_ERROR_OF_MEAN|0.006||0.16|TWO_SIDED|95.0|-0.003|0.02|||RCRM|||Analysis was based on RCRM using unstructured covariance matrix: FCSRT Cueing Index = Treatment \* Analysis Year + IxRS defined Age Group + IxRS defined Education History + IxRS defined APOE4 Carrier Status + IxRS defined CDR Global Score.||0.02|-0.003|0.16
72581397|NCT01998841|144692464|SUPERIORITY||Hazard Ratio (HR)|0.79||||0.48|TWO_SIDED|95.0|0.41|1.52|||Stratified Log Rank||Hazard ratios were estimated by Cox regression|Stratification factors used: Age Group, Education History, APOE4 Carrier Status, Clinical Dementia Rating (CDR) Global Score.||1.52|0.41|0.48
72412248|NCT04433767|144332601|OTHER||Slope|0.4|STANDARD_ERROR_OF_MEAN|0.2||0.051|TWO_SIDED|95.0|0.0|0.8|||Mixed Models Analysis|Analyses adjusted for age and gender.||||0.80|0.00|0.051
72547752|NCT00455533|144624571|SUPERIORITY_OR_OTHER|||||||0.5477||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB2C 208977\_x\_at||||0.5477
72547753|NCT00455533|144624571|SUPERIORITY_OR_OTHER|||||||0.476||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment: ER) and the reduced model: (PCR \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB2C 213726\_x\_at||||0.4760
72547754|NCT00455533|144624571|SUPERIORITY_OR_OTHER|||||||0.3314||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment) and the reduced model: (PCR \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB2C 213726\_x\_at||||0.3314
72547755|NCT00455533|144624571|SUPERIORITY_OR_OTHER|||||||0.1005||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB2C 213726\_x\_at||||0.1005
72547756|NCT00455533|144624571|SUPERIORITY_OR_OTHER|||||||0.118||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment: ER) and the reduced model: (PCR \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB4 212664\_at||||0.1180
72547757|NCT00455533|144624571|SUPERIORITY_OR_OTHER|||||||0.158||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment) and the reduced model: (PCR \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB4 212664\_at||||0.1580
72547758|NCT00455533|144624571|SUPERIORITY_OR_OTHER|||||||0.4385||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB4 212664\_at||||0.4385
72547759|NCT00455533|144624571|SUPERIORITY_OR_OTHER|||||||0.7324||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment: ER) and the reduced model: (PCR \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB6 209191\_at||||0.7324
72547760|NCT00455533|144624571|SUPERIORITY_OR_OTHER|||||||0.2657||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment) and the reduced model: (PCR \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB6 209191\_at||||0.2657
72547761|NCT00455533|144624571|SUPERIORITY_OR_OTHER|||||||0.5637||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB6 209191\_at||||0.5637
72547762|NCT00455533|144624571|SUPERIORITY_OR_OTHER|||||||0.4473||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment: ER) and the reduced model: (PCR \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TYMS 202589\_at||||0.4473
72547763|NCT00455533|144624571|SUPERIORITY_OR_OTHER|||||||0.3292||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment) and the reduced model: (PCR \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||TYMS 202589\_at||||0.3292
72547764|NCT00455533|144624571|SUPERIORITY_OR_OTHER|||||||0.2054||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TYMS 202589\_at||||0.2054
72547765|NCT00455533|144624571|SUPERIORITY_OR_OTHER|||||||0.5226||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment: ER) and the reduced model: (PCR \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TYMS 217684\_at||||0.5226
72547766|NCT00455533|144624571|SUPERIORITY_OR_OTHER|||||||0.172||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment) and the reduced model: (PCR \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||TYMS 217684\_at||||0.1720
72547767|NCT00455533|144624571|SUPERIORITY_OR_OTHER|||||||0.3346||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TYMS 217684\_at||||0.3346
72547768|NCT00455533|144624572|SUPERIORITY_OR_OTHER|||||||0.5604||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment: ER) and the reduced model: (PCR/RCB1 \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||ABCB1 209993\_at||||0.5604
72547769|NCT00455533|144624572|SUPERIORITY_OR_OTHER|||||||0.2715||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment) and the reduced model: (PCR/RCB1 \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||ABCB1 209993\_at||||0.2715
72547770|NCT00455533|144624572|SUPERIORITY_OR_OTHER|||||||0.5268||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR/RCB1 \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||ABCB1 209993\_at||||0.5268
72547771|NCT00455533|144624572|SUPERIORITY_OR_OTHER|||||||0.6058||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment: ER) and the reduced model: (PCR/RCB1 \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||ABCB1 /// ABCB4 209994\_s\_at||||0.6058
72547772|NCT00455533|144624572|SUPERIORITY_OR_OTHER|||||||0.1918||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment) and the reduced model: (PCR/RCB1 \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||ABCB1 /// ABCB4 209994\_s\_at||||0.1918
72547773|NCT00455533|144624572|SUPERIORITY_OR_OTHER|||||||0.6712||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR/RCB1 \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||ABCB1 /// ABCB4 209994\_s\_at||||0.6712
72547774|NCT00455533|144624572|SUPERIORITY_OR_OTHER|||||||0.9195||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment: ER) and the reduced model: (PCR/RCB1 \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||BRCA1 211851\_x\_at||||0.9195
72547775|NCT00455533|144624572|SUPERIORITY_OR_OTHER|||||||0.7021||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment) and the reduced model: (PCR/RCB1 \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||BRCA1 211851\_x\_at||||0.7021
72547776|NCT00455533|144624572|SUPERIORITY_OR_OTHER|||||||0.391||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR/RCB1 \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||BRCA1 211851\_x\_at||||0.3910
72581398|NCT01998841|144692465|SUPERIORITY||Hazard Ratio (HR)|0.92||||0.76|TWO_SIDED|95.0|0.53|1.59|||Stratified Log Rank||Hazard ratios were estimated by Cox regression.|Stratification factors used: Age Group, Education History, APOE4 Carrier Status.||1.59|0.53|0.76
72581399|NCT01998841|144692466|SUPERIORITY||Difference in Annualized Rate of Change|-0.03|STANDARD_ERROR_OF_MEAN|0.06||0.64|TWO_SIDED|95.0|-0.15|0.09|||RCRM|||Analysis was based on RCRM using unstructured covariance matrix: CDR-SB = Treatment \* Analysis Year + IxRS defined Age Group + IxRS defined Education History + IxRS defined APOE4 Carrier Status + IxRS defined CDR Global Score.||0.09|-0.15|0.64
72581400|NCT01998841|144692467|SUPERIORITY||Difference in Annualized Rate of Change|0.18|STANDARD_ERROR_OF_MEAN|0.29||0.55|TWO_SIDED|95.0|-0.4|0.75|||RCRM|||Analysis was based on RCRM using unstructured covariance matrix: RBANS Total Score = Treatment \* Analysis Year + IxRS defined Age Group + IxRS defined Education History + IxRS defined APOE4 Carrier Status + IxRS defined CDR Global Score.||0.75|-0.40|0.55
72581401|NCT01998841|144692468|SUPERIORITY||Difference in Annualized Rate of Change|-0.0006|STANDARD_ERROR_OF_MEAN|0.002||0.69|TWO_SIDED|95.0|-0.0037|0.0024|||RCRM|||Analysis was based on RCRM using unstructured covariance matrix: PET SUVR = Treatment \* Analysis Year + IxRS defined Age Group + IxRS defined Education History + IxRS defined APOE4 Carrier Status + IxRS defined CDR Global Score.||0.0024|-0.0037|0.69
72581402|NCT01998841|144692469|SUPERIORITY||Difference in Annualized Rate of Change|0.003|STANDARD_ERROR_OF_MEAN|0.002||0.25|TWO_SIDED|95.0|-0.002|0.007|||RCRM|||Analysis was based on RCRM using unstructured covariance matrix: FDG-PET = Treatment \* Analysis Year + IxRS defined Age Group + IxRS defined Education History + IxRS defined APOE4 Carrier Status + IxRS defined CDR Global Score.||0.007|-0.002|0.25
72581403|NCT01998841|144692470|SUPERIORITY||Difference in Annualized Rate of Change|107.78|STANDARD_ERROR_OF_MEAN|92.28||0.25|TWO_SIDED|95.0|-74.5|290.05|||RCRM|||Whole Brain: Analysis was based on RCRM using unstructured covariance matrix: MRI Whole Brain (Derived) = Treatment \* Analysis Year + IxRS defined Age Group + IxRS defined Education History + IxRS defined APOE4 Carrier Status + IxRS defined CDR Global Score.||290.05|-74.5|0.25
72581404|NCT01998841|144692470|SUPERIORITY||Difference in Annualized Rate of Change|9.6|STANDARD_ERROR_OF_MEAN|17.39||0.58|TWO_SIDED|95.0|-24.74|43.94|||RCRM|||Bilateral Hippocampus: Analysis was based on RCRM using unstructured covariance matrix: MRI Bilateral Hippocampus = Treatment \* Analysis Year + IxRS defined Age Group + IxRS defined Education History + IxRS defined APOE4 Carrier Status + IxRS defined CDR Global Score.||43.94|-24.74|0.58
72581405|NCT01998841|144692470|SUPERIORITY||Difference in Annualized Rate of Change|19.92|STANDARD_ERROR_OF_MEAN|213.08||0.93|TWO_SIDED|95.0|-400.78|440.62|||RCRM|||Ventricles: Analysis was based on RCRM using unstructured covariance matrix: MRI Ventricles = Treatment \* Analysis Year + IxRS defined Age Group + IxRS defined Education History + IxRS defined APOE4 Carrier Status + IxRS defined CDR Global Score.||440.62|-400.78|0.93
72581406|NCT01998841|144692471|SUPERIORITY||Difference in Annualized Rate of Change|-1.97|STANDARD_ERROR_OF_MEAN|3.09||0.53|TWO_SIDED|95.0|-8.17|4.23|||RCRM|||tTau: Analysis was based on RCRM using unstructured covariance matrix: CSF tTau = Treatment \* Analysis Year + IxRS defined Age Group + IxRS defined Education History + IxRS defined APOE4 Carrier Status + IxRS defined CDR Global Score.||4.23|-8.17|0.53
72581407|NCT01998841|144692471|SUPERIORITY||Difference in Annualized Rate of Change|-0.5|STANDARD_ERROR_OF_MEAN|0.46||0.28|TWO_SIDED|95.0|-1.43|0.43|||RCRM|||pTau: Analysis was based on RCRM using unstructured covariance matrix: CSF pTau = Treatment \* Analysis Year + IxRS defined Age Group + IxRS defined Education History + IxRS defined APOE4 Carrier Status + IxRS defined CDR Global Score.||0.43|-1.43|0.28
72581408|NCT01998841|144692479|SUPERIORITY||Difference in Annualized Rate of Change|7522.55|STANDARD_ERROR_OF_MEAN|313.17|<|0.0001|TWO_SIDED|95.0|6903.44|8141.65|||RCRM|||Aβ1-40: Analysis was based on RCRM using unstructured covariance matrix: APlasma Amyloid Beta 1-40 =Treatment \* Analysis Year + IxRS defined Age Group + IxRS defined Education History + IxRS defined APOE4 Carrier Status + IxRS defined CDR Global Score.||8141.65|6903.44|<0.0001
72581409|NCT01998841|144692479|SUPERIORITY||Difference in Annualized Rate of Change|556.03|STANDARD_ERROR_OF_MEAN|23.98|<|0.0001|TWO_SIDED|95.0|508.63|603.44|||RCRM|||Aβ1-42: Analysis was based on RCRM using unstructured covariance matrix: Plasma Amyloid Peptid Beta 42 =Treatment \* Analysis Year + IxRS defined Age Group + IxRS defined Education History + IxRS defined APOE4 Carrier Status + IxRS defined CDR Global Score.||603.44|508.63|<0.0001
72581410|NCT00972595|144692484|NON_INFERIORITY_OR_EQUIVALENCE|Study Primary Hypothesis: A single dose of the U.K. ZOFRAN™ (ondansetron) 8 mg tablet over-encapsulated is bioequivalent to a single dose of the U.K. ZOFRAN™ (ondansetron) 8-mg tablet. That is, the true geometric mean ratios (U.K. ZOFRAN™ tablet over-encapsulated/U.K. ZOFRAN™ tablet) of AUC0-∞ and Cmax for ondansetron each lie within the interval 0.80 to 1.25.|Least-Squares Mean Ratio|0.98||||||90.0|0.93|1.03||||||Least-Squares Mean Ratio (OE U.K. tablet / U.K. tablet): an over-encapsulated single 8 mg tablet of United Kingdom (U.K.) ZOFRAN™ (ondansetron) taken orally; a single 8 mg tablet of ZOFRAN™ (ondansetron) which is marketed in the United Kingdom (U.K.) taken orally||1.03|0.93|
72581411|NCT00972595|144692485|NON_INFERIORITY_OR_EQUIVALENCE|Study Primary Hypothesis: A single dose of the U.K. ZOFRAN™ (ondansetron) 8 mg tablet over-encapsulated is bioequivalent to a single dose of the U.K. ZOFRAN™ (ondansetron) 8 mg tablet. That is, the true geometric mean ratios (U.K. ZOFRAN™ tablet over-encapsulated/U.K. ZOFRAN™ tablet) of AUC0-∞ and Cmax for ondansetron each lie within the interval 0.80 to 1.25.|Least-Squares Mean Ratio|0.99||||||90.0|0.93|1.05||||||"Least-Squares Mean Ratio (OE U.K. tablet / U.K. tablet): an over-encapsulated single 8 mg tablet of United Kingdom~(U.K.) ZOFRAN™ (ondansetron) taken orally; a single 8 mg tablet of ZOFRAN™ (ondansetron) which is marketed in the~United Kingdom (U.K.) taken orally"||1.05|0.93|
72412249|NCT04433767|144332602|OTHER||Slope|-0.22|STANDARD_ERROR_OF_MEAN|0.06|<|0.001|TWO_SIDED|95.0|-0.33|-0.11|||Mixed Models Analysis|Analyses adjusted for age and gender.||||-0.11|-0.33|<0.001
72547777|NCT00455533|144624572|SUPERIORITY_OR_OTHER|||||||0.2909||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment: ER) and the reduced model: (PCR/RCB1 \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||BRCA1 204531\_s\_at||||0.2909
72547778|NCT00455533|144624572|SUPERIORITY_OR_OTHER|||||||0.3336||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment) and the reduced model: (PCR/RCB1 \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||BRCA1 204531\_s\_at||||0.3336
72547779|NCT00455533|144624572|SUPERIORITY_OR_OTHER|||||||0.236||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR/RCB1 \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||BRCA1 204531\_s\_at||||0.2360
72547780|NCT00455533|144624572|SUPERIORITY_OR_OTHER|||||||0.0281||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment: ER) and the reduced model: (PCR/RCB1 \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||ERCC1 203719\_at||||0.0281
72581412|NCT02085447|144692548|SUPERIORITY|||||||0.012|||||||t-test, 1 sided|||||||.012
72581413|NCT02085447|144692549|SUPERIORITY|||||||0.028|||||||t-test, 1 sided|||||||.028
72581414|NCT02085447|144692550|SUPERIORITY|||||||0.162|||||||t-test, 1 sided|||||||.162
72581415|NCT02085447|144692551|SUPERIORITY|||||||0.021|||||||t-test, 1 sided|||||||.021
72581416|NCT02085447|144692552|SUPERIORITY|||||||0.005|||||||t-test, 1 sided|||||||.005
72581417|NCT02085447|144692553|SUPERIORITY||||||<|0.001|||||||t-test, 1 sided|||||||<.001
72581418|NCT02085447|144692554|SUPERIORITY|||||||0.197|||||||t-test, 1 sided|||||||.197
72581419|NCT02085447|144692555|SUPERIORITY||||||<|0.001|||||||t-test, 1 sided|||||||<.001
72581420|NCT02085447|144692556|SUPERIORITY||||||<|0.001|||||||t-test, 1 sided|||||||<.001
72581421|NCT02085447|144692557|SUPERIORITY||||||<|0.001|||||||t-test, 1 sided|||||||<.001
72581422|NCT02085447|144692558|SUPERIORITY|||||||0.053|||||||t-test, 1 sided|||||||.053
72581423|NCT02085447|144692559|SUPERIORITY||||||<|0.001|||||||t-test, 1 sided|||||||<.001
72547781|NCT00455533|144624572|SUPERIORITY_OR_OTHER|||||||0.0434||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment) and the reduced model: (PCR/RCB1 \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||ERCC1 203719\_at||||0.0434
72547782|NCT00455533|144624572|SUPERIORITY_OR_OTHER|||||||0.0283||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR/RCB1 \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||ERCC1 203719\_at||||0.0283
72547783|NCT00455533|144624572|SUPERIORITY_OR_OTHER|||||||0.0151||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment: ER) and the reduced model: (PCR/RCB1 \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||ERCC1 203720\_s\_at||||0.0151
72581424|NCT02085447|144692560|SUPERIORITY|||||||0.821|||||||t-test, 1 sided|||||||.821
72581425|NCT02085447|144692561|SUPERIORITY|||||||0.33|||||||t-test, 1 sided|||||||.330
72581426|NCT02085447|144692562|SUPERIORITY|||||||0.425|||||||t-test, 1 sided|||||||.425
72581427|NCT02085447|144692563|SUPERIORITY|||||||0.577|||||||t-test, 1 sided|||||||.577
72581428|NCT02085447|144692564|SUPERIORITY|||||||0.33|||||||t-test, 1 sided|||||||.330
72581429|NCT02085447|144692565|SUPERIORITY|||||||0.706|||||||t-test, 1 sided|||||||.706
72581430|NCT02085447|144692566|SUPERIORITY|||||||0.481|||||||t-test, 1 sided|||||||.481
72581431|NCT02085447|144692567|SUPERIORITY|||||||0.02|||||||t-test, 1 sided|||||||.020
72581432|NCT02085447|144692568|SUPERIORITY|||||||0.103|||||||t-test, 1 sided|||||||.103
72581433|NCT02085447|144692569|SUPERIORITY|||||||0.063|||||||t-test, 1 sided|||||||.063
72581434|NCT04779879|144692578|OTHER||Ratio of geometric least squares mean|1.04|||||TWO_SIDED|90.0|0.98|1.09|||||Analysis was performed using an Analysis of covariance (ANCOVA) model with covariates of treatment and Baseline logarithm (base 10) viral load.|||1.09|0.98|
72581435|NCT04779879|144692579|OTHER||Ratio of geometric least squares mean|1.02|||||TWO_SIDED|90.0|0.94|1.11|||||Analysis was performed using an ANCOVA model with covariates of treatment, and Baseline logarithm (base10) viral load and randomization stratification factor (prior exposure to an authorized or approved SARS-CoV-2 vaccine).|||1.11|0.94|
72581436|NCT04779879|144692608|OTHER||Ratio of geometric least squares mean|1.05|||||TWO_SIDED|90.0|1.0|1.11|||||Analysis was performed using an ANCOVA model with covariates of treatment and Baseline logarithm (base 10) viral load.|||1.11|1.00|
72581437|NCT04779879|144692609|OTHER||Ratio of geometric least squares mean|1.02|||||TWO_SIDED|90.0|0.97|1.07|||||Analysis was performed using an ANCOVA model with covariates of treatment and Baseline logarithm (base 10) viral load.|||1.07|0.97|
72581438|NCT04779879|144692610|OTHER||Ratio of geometric least squares mean|1.01|||||TWO_SIDED|90.0|0.93|1.09|||||Analysis was performed using an ANCOVA model with covariates of treatment, Baseline logarithm (base 10) viral load and randomization stratification factor (prior exposure to an authorized or approved SARS-CoV-2 vaccine).|||1.09|0.93|
72581439|NCT04779879|144692611|OTHER||Ratio of geometric least squares mean|1.02|||||TWO_SIDED|90.0|0.94|1.1|||||Analysis was performed using an ANCOVA model with covariates of treatment, Baseline logarithm (base 10) viral load and randomization stratification factor (prior exposure to an authorized or approved SARS-CoV-2 vaccine).|||1.10|0.94|
72581440|NCT04779879|144692672|OTHER||Ratio of geometric least squares mean|0.66|||||TWO_SIDED|90.0|0.48|0.89|||||Drug bioavailability was analyzed using an ANCOVA model with treatment and weight at Baseline as covariates.|||0.89|0.48|
72581441|NCT04779879|144692672|OTHER||Ratio of geometric least squares mean|0.58|||||TWO_SIDED|90.0|0.43|0.79|||||Drug bioavailability was analyzed using an ANCOVA model with treatment and weight at Baseline as covariates.|||0.79|0.43|
72581442|NCT04779879|144692673|OTHER||Ratio of geometric least squares mean|1.14|||||TWO_SIDED|90.0|0.67|1.95|||||Dose proportionality was analyzed using an ANOVA model with treatment (250mg, 500mg) as a covariate, for each parameter of interest.|||1.95|0.67|
72581443|NCT04779879|144692674|OTHER||Ratio of geometric least squares mean|1.06|||||TWO_SIDED|90.0|0.69|1.62|||||Dose proportionality was analyzed using an ANOVA model with treatment (250mg, 500mg) as a covariate, for each parameter of interest.|||1.62|0.69|
72412250|NCT04433767|144332603|OTHER||Slope|0.43|STANDARD_ERROR_OF_MEAN|0.13||0.002|TWO_SIDED|95.0|0.17|0.69|||Mixed Models Analysis|Analyses adjusted for age and gender.||||0.69|0.17|0.002
72412251|NCT04433767|144332604|OTHER||Slope|0.52|STANDARD_ERROR_OF_MEAN|0.14||0.002|TWO_SIDED|95.0|0.21|0.83|||Mixed Models Analysis|Analyses adjusted for age and gender.||||0.83|0.21|0.002
72547784|NCT00455533|144624572|SUPERIORITY_OR_OTHER|||||||0.1999||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment) and the reduced model: (PCR/RCB1 \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||ERCC1 203720\_s\_at||||0.1999
72547785|NCT00455533|144624572|SUPERIORITY_OR_OTHER|||||||0.0146||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR/RCB1 \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||ERCC1 203720\_s\_at||||0.0146
72581444|NCT04779879|144692675|OTHER||Ratio of geometric least squares mean|1.11|||||TWO_SIDED|90.0|0.68|1.82|||||Dose proportionality was analyzed using an ANOVA model with treatment (250mg, 500mg) as a covariate, for each parameter of interest.|||1.82|0.68|
72581445|NCT04779879|144692676|OTHER||Ratio of geometric least squares mean|1.28|||||TWO_SIDED|90.0|0.77|2.12|||||Dose proportionality was analyzed using an ANOVA model with treatment (250mg, 500mg) as a covariate, for each parameter of interest.|||2.12|0.77|
72581446|NCT02854527|144692701|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Geometric mean ratio (T/R1) (%)|96.39|STANDARD_DEVIATION|19.4|||TWO_SIDED|90.0|88.22|105.33|||ANOVA|Analysis of variance (ANOVA) model on the logarithmic scale including effects: 'sequence', 'subject within sequence', 'period' and 'treatment'.|Least square estimates of log-transformed PK endpoint for T and R1 were back transformed to original scale to get adjusted gMean ratio (T/R1) and its 2-sided 90% CI. Standard deviation is intra-individual geometric coefficient of variation (%).|This statistical analysis assess the effect of the other cocktail compounds in treatment T on the first primary outcome measure of treatment R1.||105.33|88.22|
72581447|NCT02854527|144692702|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Geometric mean ratio (T/R1) (%)|93.17|STANDARD_DEVIATION|24.1|||TWO_SIDED|90.0|83.49|103.97|||ANOVA|Analysis of variance (ANOVA) model on the logarithmic scale including effects: 'sequence', 'subject within sequence', 'period' and 'treatment'.|Least square estimates of log-transformed PK endpoint for T and R1 were back transformed to original scale to get adjusted gMean ratio (T/R1) and its 2-sided 90% CI. Standard deviation is intra-individual geometric coefficient of variation (%).|This statistical analysis assess the effect of the other cocktail compounds in treatment T on the second primary outcome measure of treatment R1.||103.97|83.49|
72581448|NCT02854527|144692703|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Geometric mean ratio (T/R2) (%)|102.62|STANDARD_DEVIATION|20.4|||TWO_SIDED|90.0|93.82|112.25|||ANOVA|Analysis of variance (ANOVA) model on the logarithmic scale including effects: 'sequence', 'subject within sequence', 'period' and 'treatment'.|Least square estimates of log-transformed PK endpoint for T and R2 were back transformed to original scale to get adjusted gMean ratio (T/R2) and its 2-sided 90% CI. Standard deviation is intra-individual geometric coefficient of variation (%).|This statistical analysis assess the effect of the other cocktail compounds in treatment T on the first primary outcome measure of treatment R2.||112.25|93.82|
72581449|NCT02854527|144692704|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Geometric mean ratio (T/R2) (%)|103.96|STANDARD_DEVIATION|24.0|||TWO_SIDED|90.0|93.6|115.46|||ANOVA|Analysis of variance (ANOVA) model on the logarithmic scale including effects: 'sequence', 'subject within sequence', 'period' and 'treatment'.|Least square estimates of log-transformed PK endpoint for T and R2 were back transformed to original scale to get adjusted gMean ratio (T/R2) and its 2-sided 90% CI. Standard deviation is intra-individual geometric coefficient of variation (%).|This statistical analysis assess the effect of the other cocktail compounds in treatment T on the second primary outcome measure of treatment R2.||115.46|93.60|
72581450|NCT02854527|144692705|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Geometric mean ratio (T/R3) (%)|97.49|STANDARD_DEVIATION|9.0|||TWO_SIDED|90.0|93.54|101.61|||ANOVA|Analysis of variance (ANOVA) model on the logarithmic scale including effects: 'sequence', 'subject within sequence', 'period' and 'treatment'.|Least square estimates of log-transformed PK endpoint for T and R3 were back transformed to original scale to get adjusted gMean ratio (T/R3) and its 2-sided 90% CI. Standard deviation is intra-individual geometric coefficient of variation (%).|This statistical analysis assess the effect of the other cocktail compounds in treatment T on the first primary outcome measure of treatment R3.||101.61|93.54|
72581451|NCT02854527|144692706|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Geometric mean ratio (T/R3) (%)|98.25|STANDARD_DEVIATION|14.7|||TWO_SIDED|90.0|91.85|105.09|||ANOVA|Analysis of variance (ANOVA) model on the logarithmic scale including effects: 'sequence', 'subject within sequence', 'period' and 'treatment'.|Least square estimates of log-transformed PK endpoint for T and R3 were back transformed to original scale to get adjusted gMean ratio (T/R3) and its 2-sided 90% CI. Standard deviation is intra-individual geometric coefficient of variation (%).|This statistical analysis assess the effect of the other cocktail compounds in treatment T on the second primary outcome measure of treatment R3.||105.09|91.85|
72581452|NCT02854527|144692707|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Geometric mean ratio (T/R4) (%)|105.01|STANDARD_DEVIATION|18.8|||TWO_SIDED|90.0|96.39|114.4|||ANOVA|Analysis of variance (ANOVA) model on the logarithmic scale including effects: 'sequence', 'subject within sequence', 'period' and 'treatment'.|Least square estimates of log-transformed PK endpoint for T and R4 were back transformed to original scale to get adjusted gMean ratio (T/R4) and its 2-sided 90% CI. Standard deviation is intra-individual geometric coefficient of variation (%).|This statistical analysis assess the effect of the other cocktail compounds in treatment T on the first primary outcome measure of treatment R4.||114.40|96.39|
72581453|NCT02854527|144692708|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Geometric mean ratio (T/R4) (%)|104.28|STANDARD_DEVIATION|20.6|||TWO_SIDED|90.0|94.95|114.53|||ANOVA|Analysis of variance (ANOVA) model on the logarithmic scale including effects: 'sequence', 'subject within sequence', 'period' and 'treatment'.|Least square estimates of log-transformed PK endpoint for T and R4 were back transformed to original scale to get adjusted gMean ratio (T/R4) and its 2-sided 90% CI. Standard deviation is intra-individual geometric coefficient of variation (%).|This statistical analysis assess the effect of the other cocktail compounds in treatment T on the second primary outcome measure of treatment R4.||114.53|94.95|
72547786|NCT00455533|144624572|SUPERIORITY_OR_OTHER|||||||0.1185||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment: ER) and the reduced model: (PCR/RCB1 \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||GTSE1 204315\_s\_at||||0.1185
72547787|NCT00455533|144624572|SUPERIORITY_OR_OTHER|||||||0.8705||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment) and the reduced model: (PCR/RCB1 \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||GTSE1 204315\_s\_at||||0.8705
72581454|NCT02854527|144692709|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Geometric mean ratio (T/R1) (%)|96.53|STANDARD_DEVIATION|10.1|||TWO_SIDED|90.0|92.08|101.2|||ANOVA|Analysis of variance (ANOVA) model on the logarithmic scale including effects: 'sequence', 'subject within sequence', 'period' and 'treatment'.|Least square estimates of log-transformed PK endpoint for T and R1 were back transformed to original scale to get adjusted gMean ratio (T/R1) and its 2-sided 90% CI. Standard deviation is intra-individual geometric coefficient of variation (%).|This statistical analysis assess the effect of the other cocktail compounds in treatment T on the secondary outcome measure of treatment R1.||101.20|92.08|
72547788|NCT00455533|144624572|SUPERIORITY_OR_OTHER|||||||0.0284||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR/RCB1 \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||GTSE1 204315\_s\_at||||0.0284
72547789|NCT00455533|144624572|SUPERIORITY_OR_OTHER|||||||0.0399||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment: ER) and the reduced model: (PCR/RCB1 \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||GTSE1 204317\_at||||0.0399
72581455|NCT02854527|144692710|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Geometric mean ratio (T/R2) (%)|97.4|STANDARD_DEVIATION|9.6|||TWO_SIDED|90.0|90.87|104.41|||ANOVA|Analysis of variance (ANOVA) model on the logarithmic scale including effects: 'sequence', 'subject within sequence', 'period' and 'treatment'.|Least square estimates of log-transformed PK endpoint for T and R2 were back transformed to original scale to get adjusted gMean ratio (T/R2) and its 2-sided 90% CI. Standard deviation is intra-individual geometric coefficient of variation (%).|This statistical analysis assess the effect of the other cocktail compounds in treatment T on the secondary outcome measure of treatment R2.||104.41|90.87|
72412252|NCT04433767|144332605|OTHER||Slope|0.09|STANDARD_ERROR_OF_MEAN|0.55||0.876|TWO_SIDED|95.0|-1.05|1.23|||Mixed Models Analysis|Analyses adjusted for age and gender.||||1.23|-1.05|0.876
72412253|NCT00298233|144332606|SUPERIORITY_OR_OTHER|||||||0.42||||||Significance assessed at the 5% level for a two-sided comparison|conditional univariate logistic regressi|analysis stratified by study site||Based on previous studies, assumption was made that 30% of children and 55% of adults treated with standard dose oseltamivir would test negative for virus on day five. This would require a sample size of 242 patients to show a 20% absolute improvement in cessation of viral shedding with 85% power and a two sided α of 0.05. To allow for study withdrawals, the target sample size was set at 300 patients.||||0.42
72412254|NCT00298233|144332607|SUPERIORITY_OR_OTHER|||||||0.54||||||Significance assessed at the 5% level for a two-sided comparison|Mantel Haenszel|||||||0.54
72412255|NCT00298233|144332608|SUPERIORITY_OR_OTHER|||||||0.54||||||Significance assessed at the 5% level for a two-sided comparison|Mantel Haenszel|Mantel-Haenszel chi-square stratified by study site||||||0.54
72412256|NCT00298233|144332609|SUPERIORITY_OR_OTHER|||||||0.48||||||Significance assessed at the 5% level for a two-sided comparison|Kruskal-Wallis|||||||0.48
72412257|NCT00298233|144332610|SUPERIORITY_OR_OTHER|||||||0.66||||||Significance assessed at the 5% level for a two-sided comparison|Kruskal-Wallis|||||||0.66
72412258|NCT00298233|144332611|SUPERIORITY_OR_OTHER|||||||0.58||||||Significance assessed at the 5% level for a two-sided comparison|Kruskal-Wallis|||||||0.58
72412259|NCT00439777|144332626|NON_INFERIORITY_OR_EQUIVALENCE|Assuming equal efficacy, a total of 88 events will give a power of 90% to demonstrate that rivaroxaban is at least as effective as the comparator, considering a relative non-inferiority upper CI margin for the hazard ratio of 2.0 (two-sided alpha=0.05). The mean overall incidence for the primary efficacy outcome of 3% was expected and therefore 1465 patients per group would be needed. This number was to be adjusted based on the observed overall incidence of symptomatic recurrent VTE.|Hazard Ratio (HR)|1.12|STANDARD_ERROR_OF_MEAN|0.2067||0.0026|TWO_SIDED|95.0|0.75|1.68|||Regression, Cox|Stratified by intend treatment duration, adjusted for presence of active malignancy at baseline|The standard error of the log hazard ratio was estimated.|The rivaroxaban to comparator hazard ratio was computed with a 95% CI (confidence interval) (two-sided testing). Based on this model, rivaroxaban would be considered at least as effective as the comparator if the upper limit of the CI was less than 2.0.||1.68|0.75|0.0026
72412260|NCT00439777|144332627|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.16|STANDARD_ERROR_OF_MEAN|0.15||0.33|TWO_SIDED|95.0|0.86|1.56||Nominal p-value|Regression, Cox||The standard error of the log hazard ratio was estimated.|Stratified by intend treatment duration, adjusted for presence of active malignancy at baseline.||1.56|0.86|0.33
72412261|NCT00439777|144332628|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.85|STANDARD_ERROR_OF_MEAN|0.1499||0.275|TWO_SIDED|95.0|0.63|1.14||Nominal p-value|Regression, Cox|Stratified by intend treatment duration, adjusted for presence of active malignancy at baseline|The standard error of the log hazard ratio was estimated.|||1.14|0.63|0.275
72547790|NCT00455533|144624572|SUPERIORITY_OR_OTHER|||||||0.0136||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment) and the reduced model: (PCR/RCB1 \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||GTSE1 204317\_at||||0.0136
72412262|NCT00439777|144332629|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.16|STANDARD_ERROR_OF_MEAN|0.257||0.55|TWO_SIDED|95.0|0.7|1.93||nominal p-value|Regression, Cox|Stratified by intend treatment duration, adjusted for presence of active malignancy at baseline.|The standard error of the log hazard ratio was estimated.|||1.93|0.70|0.55
72412263|NCT00439777|144332630|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.94|STANDARD_ERROR_OF_MEAN|0.3289||0.85|TWO_SIDED|95.0|0.49|1.79||Nominal p-value|Regression, Cox|Stratified by intend treatment duration, adjusted for presence of active malignancy at baseline.|The standard error of the log hazard ratio was estimated.|||1.79|0.49|0.85
72412264|NCT00439777|144332631|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.9|STANDARD_ERROR_OF_MEAN|0.08756||0.23|TWO_SIDED|95.0|0.76|1.07||If the primary efficacy analysis shows that rivaroxaban is non-inferior to the comparator, the principal safety outcome was to be compared between treatment groups to maintain the overall type I error of 0.05 (2-sided) (a closed testing procedure).|Regression, Cox|Stratified by intend treatment duration, adjusted for presence of active malignancy at baseline.|The standard error of the log hazard ratio was estimated.|||1.07|0.76|0.23
72412265|NCT03855189|144332655|OTHER||||||<|0.01|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||<0.01
72412266|NCT03855189|144332655|OTHER||||||<|0.01|||||||ANOVA|||Pairwise treatment comparison based on t-test from ANOVA.||||<0.01
72412267|NCT03855189|144332655|OTHER|||||||0.06|||||||ANOVA|||Pairwise treatment comparison based on t-test from ANOVA.||||0.06
72412268|NCT03855189|144332656|OTHER|||||||0.04|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||0.04
72412269|NCT03855189|144332656|OTHER|||||||0.01|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||0.01
72547791|NCT00455533|144624572|SUPERIORITY_OR_OTHER|||||||0.0576||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR/RCB1 \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||GTSE1 204317\_at||||0.0576
72547792|NCT00455533|144624572|SUPERIORITY_OR_OTHER|||||||0.2245||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment: ER) and the reduced model: (PCR/RCB1 \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||GTSE1 215942\_s\_at||||0.2245
72547793|NCT00455533|144624572|SUPERIORITY_OR_OTHER|||||||0.1388||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment) and the reduced model: (PCR/RCB1 \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||GTSE1 215942\_s\_at||||0.1388
72547794|NCT00455533|144624572|SUPERIORITY_OR_OTHER|||||||0.0692||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR/RCB1 \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||GTSE1 215942\_s\_at||||0.0692
72547795|NCT00455533|144624572|SUPERIORITY_OR_OTHER|||||||0.1058||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment: ER) and the reduced model: (PCR/RCB1 \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||GTSE1 204318\_s\_at||||0.1058
72547796|NCT00455533|144624572|SUPERIORITY_OR_OTHER|||||||0.2688||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment) and the reduced model: (PCR/RCB1 \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||GTSE1 204318\_s\_at||||0.2688
72547797|NCT00455533|144624572|SUPERIORITY_OR_OTHER|||||||0.0192||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR/RCB1 \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||GTSE1 204318\_s\_at||||0.0192
72547798|NCT00455533|144624572|SUPERIORITY_OR_OTHER|||||||0.0033||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment: ER) and the reduced model: (PCR/RCB1 \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||GTSE1 211040\_x\_at||||0.0033
72547799|NCT00455533|144624572|SUPERIORITY_OR_OTHER|||||||0.2053||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment) and the reduced model: (PCR/RCB1 \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||GTSE1 211040\_x\_at||||0.2053
72547800|NCT00455533|144624572|SUPERIORITY_OR_OTHER|||||||0.0032||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR/RCB1 \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||GTSE1 211040\_x\_at||||0.0032
72581456|NCT02854527|144692711|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Geometric mean ratio (T/R3) (%)|97.5|STANDARD_DEVIATION|8.9|||TWO_SIDED|90.0|93.58|101.58|||ANOVA|Analysis of variance (ANOVA) model on the logarithmic scale including effects: 'sequence', 'subject within sequence', 'period' and 'treatment'.|Least square estimates of log-transformed PK endpoint for T and R3 were back transformed to original scale to get adjusted gMean ratio (T/R3) and its 2-sided 90% CI. Standard deviation is intra-individual geometric coefficient of variation (%).|This statistical analysis assess the effect of the other cocktail compounds in treatment T on the secondary outcome measure of treatment R3.||101.58|93.58|
72581457|NCT02854527|144692712|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Geometric mean ratio (T/R4) (%)|107.63|STANDARD_DEVIATION|19.4|||TWO_SIDED|90.0|97.04|119.39|||ANOVA|Analysis of variance (ANOVA) model on the logarithmic scale including effects: 'sequence', 'subject within sequence', 'period' and 'treatment'.|Least square estimates of log-transformed PK endpoint for T and R4 were back transformed to original scale to get adjusted gMean ratio (T/R4) and its 2-sided 90% CI. Standard deviation is intra-individual geometric coefficient of variation (%).|This statistical analysis assess the effect of the other cocktail compounds in treatment T on the secondary outcome measure of treatment R4.||119.39|97.04|
72581458|NCT02899962|144692746|SUPERIORITY|The primary endpoint was time to first relapse during the maintenance phase. This was calculated as the number of days from randomisation to the day where the subject had the first relapse confirmed. For subjects who either did not encounter a relapse or were withdrawn from the trial, the number of days was treated as a censored observation at the day of end of trial visit.|Hazard Ratio (HR)|0.57|||<|0.001|TWO_SIDED|95.0|0.47|0.69|||Regression, Cox||Estimates are obtained from a proportional hazards model with treatment group,pooled trial site,disease severity at maintenance baseline (Week 4; determined by PGA) as factors.|All randomized subjects were considered for statistical analysis.||0.69|0.47|<0.001
72581459|NCT02899962|144692747|SUPERIORITY||Mean Difference (Net)|0.11|||<|0.001|TWO_SIDED|95.0|0.08|0.14|||ANOVA|Factors adjusted for in the ANOVA model were treatment group, pooled trial site, and disease severity at maintenance baseline (PGA).|Multiple imputation of data for withdrawn subjects was done using 100 imputations and depended on whether the subject's reason for withdrawal potentially was related to treatment. Length of the maintenance phase was assumed to be 52 weeks (364 days)|The number of days in remission was calculated as the sum of days where the subject was in remission periods. The proportion of days in remission was calculated as the number of days in remission divided by the length of the maintenance phase in days.||0.14|0.08|<0.001
72581460|NCT02899962|144692748|SUPERIORITY||Rate ratio|0.54|||<|0.001|TWO_SIDED|95.0|0.46|0.63|||Poisson regression||The number of relapses was analysed using a Poisson regression model with treatment group,pooled sites,disease severity at maintenance baseline as factors, subject as random effect, and time at risk as an offset.|||0.63|0.46|<0.001
72412270|NCT03855189|144332656|OTHER|||||||0.5|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||0.50
72547801|NCT00455533|144624572|SUPERIORITY_OR_OTHER|||||||0.6783||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment: ER) and the reduced model: (PCR/RCB1 \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||KLK10 209792\_s\_at||||0.6783
72547802|NCT00455533|144624572|SUPERIORITY_OR_OTHER|||||||0.163||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment) and the reduced model: (PCR/RCB1 \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||KLK10 209792\_s\_at||||0.1630
72547803|NCT00455533|144624572|SUPERIORITY_OR_OTHER|||||||0.2944||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR/RCB1 \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||KLK10 209792\_s\_at||||0.2944
72547804|NCT00455533|144624572|SUPERIORITY_OR_OTHER|||||||0.3727||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment: ER) and the reduced model: (PCR/RCB1 \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||KLK10 215808\_at||||0.3727
72412271|NCT03855189|144332659|OTHER||||||<|0.01|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||<0.01
72412272|NCT03855189|144332659|OTHER||||||<|0.01|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||<0.01
72412273|NCT03855189|144332659|OTHER|||||||0.11|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||0.11
72412274|NCT03855189|144332660|OTHER|||||||0.05|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||0.05
72412275|NCT03855189|144332660|OTHER||||||<|0.01|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||<0.01
72412276|NCT03855189|144332660|OTHER|||||||0.13|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||0.13
72547805|NCT00455533|144624572|SUPERIORITY_OR_OTHER|||||||0.8796||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment) and the reduced model: (PCR/RCB1 \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||KLK10 215808\_at||||0.8796
72547806|NCT00455533|144624572|SUPERIORITY_OR_OTHER|||||||0.8344||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR/RCB1 \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||KLK10 215808\_at||||0.8344
72581461|NCT00550459|144692762|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.23|STANDARD_DEVIATION|0.55||0.08|TWO_SIDED|95.0|-0.03|0.5||Secondary endpoints were ordered in 5 tiers to be analyzed only when \>=1 of the endpoints in the prior tier were significant. Since primary endpoint not stat significant, analyses of secondary endpoint tiers presented for exploratory purposes only|ANCOVA|ANCOVA with factors of treatment, disease severity, age(6 Degrees of Freedom), and covariate baseline to fit primary endpoint using the ITT dataset.||Analysis of covariance (ANCOVA) with factors of treatment,disease severity (\<130mEq/L \[mmol/L\] or ≥130mEq/L \[mmol/L\] at baseline),age (\<65, ≥65 to \<75,and ≥75 years) (factor with 6 Degrees of Freedom), and covariate baseline used to fit primary endpoint using the intent-to-treat (ITT) dataset. Estimated treatment effect and its 95% confidence interval (CI) provided under the model with p-value. A 2-sided alpha (0.05) applied to the primary analysis. Primary analysis based on observed cases (OC).||0.50|-0.03|0.08
72581462|NCT00550459|144692763|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.2|STANDARD_DEVIATION|0.63||0.21|TWO_SIDED|95.0|-0.12|0.51||ANCOVA with factors of treatment, disease severity, age, and severity by age interaction, and baseline as covariate. The estimated treatment and its 95% CI were provided under the model along with the p-value.|ANCOVA|||Per-protocol, secondary endpoints were ordered in 5 tiers and were to be analyzed only when at least 1 of the endpoints in the previous tier was significant. As the primary endpoint was not statistically significant, the analyses of subsequent secondary endpoint tiers are presented for exploratory purposes only.||0.51|-0.12|0.21
72581463|NCT00550459|144692764|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.27|STANDARD_DEVIATION|0.41||0.02|TWO_SIDED|95.0|0.04|0.51||ANCOVA with factors of treatment, disease severity, age, and severity by age interaction, and baseline as covariate. The estimated treatment and its 95% CI were provided under the model along with the p-value.|ANCOVA|||Per-protocol, secondary endpoints were ordered in 5 tiers and were to be analyzed only when at least 1 of the endpoints in the previous tier was significant. As the primary endpoint was not statistically significant, the analyses of subsequent secondary endpoint tiers are presented for exploratory purposes only.||0.51|0.04|0.02
72581464|NCT00550459|144692765|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.26|STANDARD_DEVIATION|0.83||0.21|TWO_SIDED|95.0|-0.15|0.67||ANCOVA with factors of treatment, disease severity, age, and severity by age interaction, and baseline as covariate. The estimated treatment and its 95% CI were provided under the model along with the p-value.|ANCOVA|||Per-protocol, secondary endpoints were ordered in 5 tiers and were to be analyzed only when at least 1 of the endpoints in the previous tier was significant. As the primary endpoint was not statistically significant, the analyses of subsequent secondary endpoint tiers are presented for exploratory purposes only.||0.67|-0.15|0.21
72581465|NCT00550459|144692766|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.12|STANDARD_DEVIATION|0.39||0.16|TWO_SIDED|95.0|-0.05|0.3||ANCOVA with factors of treatment, disease severity, age, and severity by age interaction, and baseline as covariate. The estimated treatment and its 95% CI were provided under the model along with the p-value.|ANCOVA|||Per-protocol, secondary endpoints were ordered in 5 tiers and were to be analyzed only when at least 1 of the endpoints in the previous tier was significant. As the primary endpoint was not statistically significant, the analyses of subsequent secondary endpoint tiers are presented for exploratory purposes only.||0.30|-0.05|0.16
72412277|NCT03855189|144332661|OTHER|||||||0.06|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||0.06
72412278|NCT03855189|144332661|OTHER|||||||0.03|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||0.03
72547807|NCT00455533|144624572|SUPERIORITY_OR_OTHER|||||||0.27||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment: ER) and the reduced model: (PCR/RCB1 \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||KLK5 222242\_s\_at||||0.2700
72547808|NCT00455533|144624572|SUPERIORITY_OR_OTHER|||||||0.2624||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment) and the reduced model: (PCR/RCB1 \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||KLK5 222242\_s\_at||||0.2624
72581466|NCT00550459|144692767|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-1.51|STANDARD_DEVIATION|3.53||0.23|TWO_SIDED|95.0|-4.02|1.0||ANCOVA with factors of treatment, disease severity, age, and severity by age interaction, and baseline as covariate. The estimated treatment and its 95% CI were provided under the model along with the p-value.|ANCOVA|||Per-protocol, secondary endpoints were ordered in 5 tiers and were to be analyzed only when at least 1 of the endpoints in the previous tier was significant. As the primary endpoint was not statistically significant, the analyses of subsequent secondary endpoint tiers are presented for exploratory purposes only.||1.00|-4.02|0.23
72547809|NCT00455533|144624572|SUPERIORITY_OR_OTHER|||||||0.083||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR/RCB1 \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||KLK5 222242\_s\_at||||0.0830
72581467|NCT00550459|144692768|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.83|STANDARD_DEVIATION|3.51||0.18|TWO_SIDED|95.0|-2.04|0.38||ANCOVA with factors of treatment, disease severity, age, and severity by age interaction, and baseline as covariate. The estimated treatment and its 95% CI were provided under the model along with the p-value.|ANCOVA|||Per-protocol, secondary endpoints were ordered in 5 tiers and were to be analyzed only when at least 1 of the endpoints in the previous tier was significant. As the primary endpoint was not statistically significant, the analyses of subsequent secondary endpoint tiers are presented for exploratory purposes only.||0.38|-2.04|0.18
72581468|NCT00550459|144692769|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.75|STANDARD_DEVIATION|3.45|<|0.0001|TWO_SIDED|95.0|2.89|6.6||ANCOVA with factors of treatment, disease severity, age, and severity by age interaction, and baseline as covariate. The estimated treatment and its 95% CI were provided under the model along with the p-value.|ANCOVA|||Per-protocol, secondary endpoints were ordered in 5 tiers and were to be analyzed only when at least 1 of the endpoints in the previous tier was significant. As the primary endpoint was not statistically significant, the analyses of subsequent secondary endpoint tiers are presented for exploratory purposes only.||6.60|2.89|<0.0001
72581469|NCT04871776|144692800|SUPERIORITY||Odds Ratio (OR)|0.87|||||TWO_SIDED|95.0|0.67|1.14|||||How vs Usual Care|We used generalized estimating equations with a logit link function and binary-distributed errors, adjusting for clinic-day clustering and including clinic as an adjustment variable for all models. This analysis is otherwise unadjusted.||1.14|0.67|
72547810|NCT00455533|144624572|SUPERIORITY_OR_OTHER|||||||0.0849||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment: ER) and the reduced model: (PCR/RCB1 \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||KLK6 204733\_at||||0.0849
72547811|NCT00455533|144624572|SUPERIORITY_OR_OTHER|||||||0.6578||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment) and the reduced model: (PCR/RCB1 \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||KLK6 204733\_at||||0.6578
72547812|NCT00455533|144624572|SUPERIORITY_OR_OTHER|||||||0.0396||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR/RCB1 \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||KLK6 204733\_at||||0.0396
72581470|NCT04871776|144692800|SUPERIORITY||Odds Ratio (OR)|1.01|||||TWO_SIDED|95.0|0.81|1.28||||||We used generalized estimating equations with a logit link function and binary-distributed errors, adjusting for clinic-day clustering and including clinic as an adjustment variable for all models. This analysis is otherwise unadjusted.||1.28|0.81|
72581471|NCT04871776|144692800|SUPERIORITY||Odds Ratio (OR)|1.2|||||TWO_SIDED|95.0|0.96|1.51||||||We used generalized estimating equations with a logit link function and binary-distributed errors, adjusting for clinic-day clustering and including clinic as an adjustment variable for all models. This analysis is otherwise unadjusted.||1.51|0.96|
72581472|NCT04871776|144692801|SUPERIORITY||Odds Ratio (OR)|0.83|||||TWO_SIDED|95.0|0.67|1.01||||||We used generalized estimating equations with a logit link function and binary-distributed errors, adjusting for clinic-day clustering and including clinic as an adjustment variable for all models. This analysis is otherwise unadjusted.||1.01|0.67|
72581473|NCT04871776|144692801|SUPERIORITY||Odds Ratio (OR)|1.03|||||TWO_SIDED|95.0|0.87|1.23||||||We used generalized estimating equations with a logit link function and binary-distributed errors, adjusting for clinic-day clustering and including clinic as an adjustment variable for all models. This analysis is otherwise unadjusted.||1.23|0.87|
72581474|NCT04871776|144692801|SUPERIORITY||Odds Ratio (OR)|1.26|||||TWO_SIDED|95.0|1.06|1.49||||||We used generalized estimating equations with a logit link function and binary-distributed errors, adjusting for clinic-day clustering and including clinic as an adjustment variable for all models. This analysis is otherwise unadjusted.||1.49|1.06|
72581475|NCT05620082|144692825|SUPERIORITY|||||||0.01|||||||Wilcoxon (Mann-Whitney)|||||||0.01
72547813|NCT00455533|144624572|SUPERIORITY_OR_OTHER|||||||0.1657||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment: ER) and the reduced model: (PCR/RCB1 \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||RRM1 201476\_s\_at||||0.1657
72547814|NCT00455533|144624572|SUPERIORITY_OR_OTHER|||||||0.0675||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment) and the reduced model: (PCR/RCB1 \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||RRM1 201476\_s\_at||||0.0675
72547815|NCT00455533|144624572|SUPERIORITY_OR_OTHER|||||||0.1071||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR/RCB1 \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||RRM1 201476\_s\_at||||0.1071
72581476|NCT05620082|144692826|SUPERIORITY|||||||0.002|||||||Wilcoxon (Mann-Whitney)|||||||0.002
72581477|NCT05620082|144692827|SUPERIORITY|||||||0.003|||||||Wilcoxon (Mann-Whitney)|||||||0.003
72547816|NCT00455533|144624572|SUPERIORITY_OR_OTHER|||||||0.0142||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment: ER) and the reduced model: (PCR/RCB1 \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||RRM1 201477\_s\_at||||0.0142
72547817|NCT00455533|144624572|SUPERIORITY_OR_OTHER|||||||0.2465||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment) and the reduced model: (PCR/RCB1 \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||RRM1 201477\_s\_at||||0.2465
72547818|NCT00455533|144624572|SUPERIORITY_OR_OTHER|||||||0.0031||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR/RCB1 \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||RRM1 201477\_s\_at||||0.0031
72547819|NCT00455533|144624572|SUPERIORITY_OR_OTHER|||||||0.1231||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment: ER) and the reduced model: (PCR/RCB1 \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB 211714\_x\_at||||0.1231
72547820|NCT00455533|144624572|SUPERIORITY_OR_OTHER|||||||0.0849||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment) and the reduced model: (PCR/RCB1 \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB 211714\_x\_at||||0.0849
72547821|NCT00455533|144624572|SUPERIORITY_OR_OTHER|||||||0.274||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR/RCB1 \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB 211714\_x\_at||||0.2740
72547822|NCT00455533|144624572|SUPERIORITY_OR_OTHER|||||||0.2383||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment: ER) and the reduced model: (PCR/RCB1 \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB 212320\_at||||0.2383
72547823|NCT00455533|144624572|SUPERIORITY_OR_OTHER|||||||0.0644||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment) and the reduced model: (PCR/RCB1 \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB 212320\_at||||0.0644
72547824|NCT00455533|144624572|SUPERIORITY_OR_OTHER|||||||0.2866||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR/RCB1 \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB 212320\_at||||0.2866
72547825|NCT00455533|144624572|SUPERIORITY_OR_OTHER|||||||0.1259||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment: ER) and the reduced model: (PCR/RCB1 \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB 209026\_x\_at||||0.1259
72547826|NCT00455533|144624572|SUPERIORITY_OR_OTHER|||||||0.0718||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment) and the reduced model: (PCR/RCB1 \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB 209026\_x\_at||||0.0718
72547827|NCT00455533|144624572|SUPERIORITY_OR_OTHER|||||||0.317||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR/RCB1 \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB 209026\_x\_at||||0.3170
72547828|NCT00455533|144624572|SUPERIORITY_OR_OTHER|||||||0.7844||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment: ER) and the reduced model: (PCR/RCB1 \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB1 208601\_s\_at||||0.7844
72547829|NCT00455533|144624572|SUPERIORITY_OR_OTHER|||||||0.4688||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment) and the reduced model: (PCR/RCB1 \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB1 208601\_s\_at||||0.4688
72547830|NCT00455533|144624572|SUPERIORITY_OR_OTHER|||||||0.8553||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR/RCB1 \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB1 208601\_s\_at||||0.8553
72547831|NCT00455533|144624572|SUPERIORITY_OR_OTHER|||||||0.6926||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment: ER) and the reduced model: (PCR/RCB1 \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB2A 204141\_at||||0.6926
72547832|NCT00455533|144624572|SUPERIORITY_OR_OTHER|||||||0.2222||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment) and the reduced model: (PCR/RCB1 \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB2A 204141\_at||||0.2222
72547833|NCT00455533|144624572|SUPERIORITY_OR_OTHER|||||||0.4676||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR/RCB1 \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB2A 204141\_at||||0.4676
72547834|NCT00455533|144624572|SUPERIORITY_OR_OTHER|||||||0.2036||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment: ER) and the reduced model: (PCR/RCB1 \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB2A /// TUBB2B 209372\_x\_at||||0.2036
72547835|NCT00455533|144624572|SUPERIORITY_OR_OTHER|||||||0.4197||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment) and the reduced model: (PCR/RCB1 \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB2A /// TUBB2B 209372\_x\_at||||0.4197
72547836|NCT00455533|144624572|SUPERIORITY_OR_OTHER|||||||0.0776||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR/RCB1 \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB2A /// TUBB2B 209372\_x\_at||||0.0776
72547837|NCT00455533|144624572|SUPERIORITY_OR_OTHER|||||||0.4076||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment: ER) and the reduced model: (PCR/RCB1 \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB2B 214023\_x\_at||||0.4076
72547838|NCT00455533|144624572|SUPERIORITY_OR_OTHER|||||||0.0629||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment) and the reduced model: (PCR/RCB1 \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB2B 214023\_x\_at||||0.0629
72547839|NCT00455533|144624572|SUPERIORITY_OR_OTHER|||||||0.2547||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR/RCB1 \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB2B 214023\_x\_at||||0.2547
72547840|NCT00455533|144624572|SUPERIORITY_OR_OTHER|||||||0.7125||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment: ER) and the reduced model: (PCR/RCB1 \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB2C 208977\_x\_at||||0.7125
72547841|NCT00455533|144624572|SUPERIORITY_OR_OTHER|||||||0.6001||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment) and the reduced model: (PCR/RCB1 \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB2C 208977\_x\_at||||0.6001
72412279|NCT03855189|144332661|OTHER|||||||0.81|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||0.81
72547842|NCT00455533|144624572|SUPERIORITY_OR_OTHER|||||||0.5398||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR/RCB1 \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB2C 208977\_x\_at||||0.5398
72547843|NCT00455533|144624572|SUPERIORITY_OR_OTHER|||||||0.397||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment: ER) and the reduced model: (PCR/RCB1 \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB2C 213726\_x\_at||||0.3970
72547844|NCT00455533|144624572|SUPERIORITY_OR_OTHER|||||||0.5085||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment) and the reduced model: (PCR/RCB1 \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB2C 213726\_x\_at||||0.5085
72581478|NCT05620082|144692828|SUPERIORITY|||||||0.1|||||||Wilcoxon (Mann-Whitney)|||Comparing Appearance of supplements||||0.10
72412280|NCT03855189|144332662|OTHER|||||||0.02|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||0.02
72547845|NCT00455533|144624572|SUPERIORITY_OR_OTHER|||||||0.1213||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR/RCB1 \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB2C 213726\_x\_at||||0.1213
72547846|NCT00455533|144624572|SUPERIORITY_OR_OTHER|||||||0.0999||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment: ER) and the reduced model: (PCR/RCB1 \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB4 212664\_at||||0.0999
72547847|NCT00455533|144624572|SUPERIORITY_OR_OTHER|||||||0.1201||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment) and the reduced model: (PCR/RCB1 \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB4 212664\_at||||0.1201
72547848|NCT00455533|144624572|SUPERIORITY_OR_OTHER|||||||0.1172||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR/RCB1 \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB4 212664\_at||||0.1172
72547849|NCT00455533|144624572|SUPERIORITY_OR_OTHER|||||||0.6596||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment: ER) and the reduced model: (PCR/RCB1 \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB6 209191\_at||||0.6596
72547850|NCT00455533|144624572|SUPERIORITY_OR_OTHER|||||||0.3289||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment) and the reduced model: (PCR/RCB1 \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB6 209191\_at||||0.3289
72547851|NCT00455533|144624572|SUPERIORITY_OR_OTHER|||||||0.3657||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR/RCB1 \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB6 209191\_at||||0.3657
72547852|NCT00455533|144624572|SUPERIORITY_OR_OTHER|||||||0.0275||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment: ER) and the reduced model: (PCR/RCB1 \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TYMS 202589\_at||||0.0275
72581479|NCT05620082|144692828|SUPERIORITY|||||||0.1|||||||Wilcoxon (Mann-Whitney)|||Comparing Smell of supplements between groups||||0.10
72581480|NCT05620082|144692828|SUPERIORITY|||||||0.08|||||||Wilcoxon (Mann-Whitney)|||Comparing Taste of supplements||||0.08
72547853|NCT00455533|144624572|SUPERIORITY_OR_OTHER|||||||0.3946||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment) and the reduced model: (PCR/RCB1 \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||TYMS 202589\_at||||0.3946
72412281|NCT03855189|144332662|OTHER||||||<|0.01|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||<0.01
72547854|NCT00455533|144624572|SUPERIORITY_OR_OTHER|||||||0.0074||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR/RCB1 \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TYMS 202589\_at||||0.0074
72547855|NCT00455533|144624572|SUPERIORITY_OR_OTHER|||||||0.2341||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment: ER) and the reduced model: (PCR/RCB1 \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TYMS 217684\_at||||0.2341
72547856|NCT00455533|144624572|SUPERIORITY_OR_OTHER|||||||0.0933||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment) and the reduced model: (PCR/RCB1 \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||TYMS 217684\_at||||0.0933
72547857|NCT00455533|144624572|SUPERIORITY_OR_OTHER|||||||0.2016||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR/RCB1 \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TYMS 217684\_at||||0.2016
72547858|NCT00455533|144624573|SUPERIORITY_OR_OTHER||Difference (bootstrap method)|-0.145|||||TWO_SIDED|90.0|-0.27|-0.017|||||ixabepilone - paclitaxel|Mem+Cyto Threshold/Negative Biomarker Status||-0.017|-0.27|
72547859|NCT00455533|144624573|SUPERIORITY_OR_OTHER||Difference (bootstrap method)|0.064|||||TWO_SIDED|90.0|-0.064|0.197|||||ixabepilone - paclitaxel|Mem+Cyto Threshold/Positive Biomarker STatus||0.197|-0.064|
72547860|NCT00455533|144624573|SUPERIORITY_OR_OTHER||Difference (bootstrap method)|-0.056|||||TWO_SIDED|90.0|-0.152|0.046|||||ixabepilone - paclitaxel|Membrane Threshold/Negative Biomarker Status||0.046|-0.152|
72547861|NCT00455533|144624573|SUPERIORITY_OR_OTHER||Difference (bootstrap method)|0.116|||||TWO_SIDED|90.0|-0.13|0.37|||||ixabepilone - paclitaxel|Membrane Threshold/Positive Biomarker Status||0.37|-0.13|
72547862|NCT00455533|144624574|SUPERIORITY_OR_OTHER||Difference (bootstrap method)|-0.114|||||TWO_SIDED|90.0|-0.258|0.22|||||ixabepilone - paclitaxel|Mem+Cyto/Negative Biomarker Status||0.22|-0.258|
72547863|NCT00455533|144624574|SUPERIORITY_OR_OTHER||DIfference (bootstrap method)|0.009|||||TWO_SIDED|90.0|-0.137|0.155|||||ixabepilone - paclitaxel|Mem+Cyto Threshold/Positive Biomarker Status||0.155|-0.137|
72547864|NCT00455533|144624574|SUPERIORITY_OR_OTHER||Difference (bootstrap method)|-0.058|||||TWO_SIDED|90.0|-0.167|0.053|||||ixabepilone - paclitaxel|Membrane Threshold/Negative Biomarker Status||0.053|-0.167|
72547865|NCT00455533|144624574|SUPERIORITY_OR_OTHER||Difference (bootstrap method)|0.049|||||TWO_SIDED|90.0|-0.227|0.309|||||ixabepilone - paclitaxel|Membrane Threshold/Positive Biomarker Status||0.309|-0.227|
72547866|NCT00455533|144624575|SUPERIORITY_OR_OTHER||Difference (bootstrap method)|-0.29|||||TWO_SIDED|90.0|-0.482|-0.094|||||ixabepilone - paclitaxel|Mem+Cyto Threshold/Negative Biomarker Status||-0.094|-0.482|
72547867|NCT00455533|144624575|SUPERIORITY_OR_OTHER||Difference (boostrap method)|0.106|||||TWO_SIDED|90.0|-0.073|0.291|||||ixabepilone - paclitaxel|Mem+Cyto Threshold/Positive Biomarker Status||0.291|-0.073|
72547868|NCT00455533|144624575|SUPERIORITY_OR_OTHER||Difference (bootstrap method)|-0.09|||||TWO_SIDED|90.0|-0.236|0.067|||||ixabepilone - paclitaxel|Membrane Threshold/Negative Biomarker Status||0.067|-0.236|
72547869|NCT00455533|144624575|SUPERIORITY_OR_OTHER||Difference (bootsrap method)|0.117|||||TWO_SIDED|90.0|-0.218|0.469|||||ixabepilone - paclitaxel|Mem+Cyto Threshold/Positive Biomarker Status||0.469|-0.218|
72547870|NCT01644890|144624652|NON_INFERIORITY|The primary PFS analysis was confirmed whether or not the upper limit of the 95% confidence interval (CI) for the hazard ratio (HR) for NK105 relative to PTX fell below the non-inferiority margin of 1.215 (\<1.215) by fitting a Cox proportional hazards model that included allocation adjustment factors other than the study site as covariates.|Hazard Ratio (HR)|1.255|||||TWO_SIDED|95.0|0.989|1.592|||||History of chemotherapy for metastatic or recurrent breast cancer (yes/no), History of treatment using a taxane anticancer drug (yes/no), ER status \[(+) or (-)\], and Disease free interval (\<12 months or ≥12 months) were covariates for adjustment.|Based on the results of previous studies, the expected median PFS was 5.5 months for PTX and 6.35 months for NK105. Assuming a randomization period of 18 months, a follow-up period of 12 months, a one-sided significance level of 2.5%, a power of 85% and the non-inferiority margin of 1.215, the number of patients was estimated to 172 pts per group, a total of 344 patients. Considering an expected withdrawal/dropout rate of approximately 20%, the target sample size was set at 414.||1.592|0.989|
72547871|NCT01644890|144624653|OTHER||Hazard Ratio (HR)|1.197|||||TWO_SIDED|95.0|0.885|1.62|||||History of chemotherapy for metastatic or recurrent breast cancer (yes/no), History of treatment using a taxane anticancer drug (yes/no), ER status \[(+) or (-)\], and Disease free interval (\<12 months or ≥12 months) were covariates for adjustment.|||1.620|0.885|
72412282|NCT03855189|144332662|OTHER|||||||0.17|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||0.17
72547872|NCT01644890|144624654|OTHER||Difference in ORR (%)|-7.5|||||TWO_SIDED|95.0|-17.4|2.7||||||||2.7|-17.4|
72547873|NCT02761980|144624661|SUPERIORITY||LSM difference|3.14||||0.002|TWO_SIDED|95.0|1.13|5.15|||ANCOVA|||Treatment difference and 95 percent (%) confidence interval (CI) were based on Least Square Mean (LSM) from analysis of covariance (ANCOVA) with treatment, and covariates time from the first RSE full dose to randomization, and baseline temperature.||5.15|1.13|0.002
72547874|NCT02761980|144624661|SUPERIORITY||LSM difference|0.91||||0.21|TWO_SIDED|95.0|-0.52|2.33|||ANCOVA|||Treatment difference and 95 % CI were based on LSM from ANCOVA with treatment, and covariates time from the first RSE full dose to randomization, and baseline temperature.||2.33|-0.52|0.210
72547875|NCT02761980|144624661|SUPERIORITY||LSM difference|0.79||||0.28|TWO_SIDED|95.0|-0.64|2.21|||ANCOVA|||Treatment difference and 95 % CI were based on LSM from ANCOVA with treatment, and covariates time from the first RSE full dose to randomization, and baseline temperature.||2.21|-0.64|0.280
72547876|NCT02761980|144624661|SUPERIORITY|Treatment difference and 95 % CI were based on LSM from ANCOVA with treatment, and covariates time from the first RSE full dose to randomization, and baseline temperature.|LSM difference|2.23||||0.03|TWO_SIDED|95.0|0.22|4.25|||ANCOVA|||||4.25|0.22|0.030
72547877|NCT02761980|144624661|SUPERIORITY|Treatment difference and 95 % CI were based on LSM from ANCOVA with treatment, and covariates time from the first RSE full dose to randomization, and baseline temperature.|LSM difference|2.35||||0.023|TWO_SIDED|95.0|0.33|4.37|||ANCOVA|||||4.37|0.33|0.023
72412283|NCT03855189|144332663|OTHER||||||<|0.01|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||<0.01
72412284|NCT03855189|144332663|OTHER|||||||0.02|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||0.02
72547878|NCT02761980|144624661|SUPERIORITY||LSM difference|-0.12||||0.864|TWO_SIDED|95.0|-1.54|1.29|||ANCOVA|||Treatment difference and 95 % CI were based on LSM from ANCOVA with treatment, and covariates time from the first RSE full dose to randomization, and baseline temperature.||1.29|-1.54|0.864
72547879|NCT02761980|144624662|SUPERIORITY|Treatment difference and 95 % CI were based on LSM from ANCOVA with treatment, and covariates time from the first RSE full dose to randomization, and baseline temperature.|LSM difference|0.9||||0.004|TWO_SIDED|95.0|0.29|1.51|||ANCOVA|||WSTD 0-2 hours||1.51|0.29|0.004
72547880|NCT02761980|144624662|SUPERIORITY|Treatment difference and 95 % CI were based on LSM from ANCOVA with treatment, and covariates time from the first RSE full dose to randomization, and baseline temperature.|LSM difference|0.39||||0.078|TWO_SIDED|95.0|-0.04|0.82|||ANCOVA|||WSTD 0-2 hours||0.82|-0.04|0.078
72547881|NCT02761980|144624662|SUPERIORITY|Treatment difference and 95 % CI were based on LSM from ANCOVA with treatment, and covariates time from the first RSE full dose to randomization, and baseline temperature.|LSM difference|0.3||||0.172|TWO_SIDED|95.0|-0.13|0.74|||ANCOVA|||WSTD 0-2 hours||0.74|-0.13|0.172
72547882|NCT02761980|144624662|SUPERIORITY|Treatment difference and 95 % CI were based on LSM from ANCOVA with treatment, and covariates time from the first RSE full dose to randomization, and baseline temperature.|LSM difference|0.51||||0.098|TWO_SIDED|95.0|-0.1|1.13|||ANCOVA|||WSTD 0-2 hours||1.13|-0.10|0.098
72581481|NCT05620082|144692828|SUPERIORITY|||||||0.7|||||||Wilcoxon (Mann-Whitney)|||Comparing Sweetness of supplements||||0.70
72581482|NCT05620082|144692828|SUPERIORITY|||||||0.02|||||||Wilcoxon (Mann-Whitney)|||Comparing Texture of supplements||||0.02
72581483|NCT05620082|144692828|SUPERIORITY|||||||0.45|||||||Wilcoxon (Mann-Whitney)|||Comparing Thickness of supplements||||0.45
72581484|NCT05620082|144692828|SUPERIORITY|||||||0.25|||||||Wilcoxon (Mann-Whitney)|||Comparing Aftertaste of supplements||||0.25
72581485|NCT05620082|144692828|SUPERIORITY|||||||0.45|||||||Wilcoxon (Mann-Whitney)|||Comparing 'Feeling in mouth' of supplements||||0.45
72581486|NCT05620082|144692828|SUPERIORITY|||||||0.06|||||||Wilcoxon (Mann-Whitney)|||Comparing 'Future choice' of supplements||||0.06
72581487|NCT05620082|144692829|SUPERIORITY|||||||0.004||||||Pairwise comparisons with Bonferroni correction revealed a significant increase in total daily energy intake from baseline to porridge timepoints (p\<0.001).|Related samples Friedman's Two-Way ANOVA|||||||0.004
72581488|NCT01321749|144692949|SUPERIORITY_OR_OTHER||||||<|0.05||5.0|||||Log Rank|||||||<0.05
72581489|NCT04179838|144692958|SUPERIORITY|||||||0.001||||||Corrected for multiple comparisons in piriform cortex|t-test, 1 sided|||Null hypothesis is that there was no difference in decoding accuracy between sleep-deprived and non-sleep deprived interventions. Paired t-test on decoding accuracy from both phases (sleep-deprived minus non-sleep deprived) against the null hypothesis of no difference.||||0.001
72581490|NCT04179838|144692959|SUPERIORITY|||||||0.021|||||||t-test, 1 sided|||Null hypothesis is that there was no change after the sleep-deprived relative to the non-sleep deprived intervention. One sample t-test on percentage change in the sleep-deprived relative to non-sleep deprived phase.||||0.021
72581491|NCT04179838|144692960|SUPERIORITY|||||||0.63|||||||t-test, 2 sided|||Null hypothesis is that there was no change after the sleep-deprived relative to the non-sleep deprived intervention. One sample t-test on percentage change in the sleep-deprived relative to non-sleep deprived phase.||||0.63
72581492|NCT04179838|144692961|SUPERIORITY|||||||0.08|||||||t-test, 2 sided|||Null hypothesis is that there was no change after the sleep-deprived relative to the non-sleep deprived intervention. One sample t-test on percentage change in the sleep-deprived relative to non-sleep deprived phase.||||0.08
72581493|NCT04179838|144692962|SUPERIORITY|||||||0.28|||||||t-test, 2 sided|||Null hypothesis is that there was no change after the sleep-deprived relative to the non-sleep deprived intervention. One sample t-test on percentage change in the sleep-deprived relative to non-sleep deprived phase.||||0.28
72581494|NCT04179838|144692963|SUPERIORITY|||||||0.5|||||||t-test, 2 sided|||Null hypothesis is that there was no change after the sleep-deprived relative to the non-sleep deprived intervention. One sample t-test on percentage change in the sleep-deprived relative to non-sleep deprived phase.||||0.50
72547883|NCT02761980|144624662|SUPERIORITY|Treatment difference and 95 % CI were based on LSM from ANCOVA with treatment, and covariates time from the first RSE full dose to randomization, and baseline temperature.|LSM difference|0.6||||0.054|TWO_SIDED|95.0|-0.01|1.21|||ANCOVA|||WSTD 0-2 hours||1.21|-0.01|0.054
72547884|NCT02761980|144624662|SUPERIORITY|Treatment difference and 95 % CI were based on LSM from ANCOVA with treatment, and covariates time from the first RSE full dose to randomization, and baseline temperature.|LSM difference|-0.09||||0.692|TWO_SIDED|95.0|-0.52|0.34|||ANCOVA|||WSTD 0-2 hours||0.34|-0.52|0.692
72581495|NCT04179838|144692964|SUPERIORITY|||||||0.58|||||||t-test, 2 sided|||Null hypothesis is that there was no change after the sleep-deprived relative to the non-sleep deprived intervention. One sample t-test on percentage change in the sleep-deprived relative to non-sleep deprived phase.||||0.58
72581496|NCT00818766|144692965|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-4.3||||0.26||95.0|-11.3|2.7|||Fisher Exact|||||2.7|-11.3|.26
72581497|NCT00818766|144692966|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.93||||0.77|TWO_SIDED|95.0|-6.1|4.3|||Fisher Exact|||||4.3|-6.1|0.77
72581498|NCT00818766|144692967|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-3.4||||0.21|TWO_SIDED|95.0|-8.3|1.6|||Fisher Exact|||||1.6|-8.3|.21
72581499|NCT00818766|144692968|SUPERIORITY_OR_OTHER|||||||0.49|||||||Fisher Exact|||||||.49
72581500|NCT00818766|144692970|SUPERIORITY_OR_OTHER|||||||0.25||95.0|||||Fisher Exact|||||||.25
72581501|NCT00818766|144692971|SUPERIORITY_OR_OTHER|||||||0.25||95.0|||||Fisher Exact|||||||.25
72581502|NCT01996241|144692979|OTHER|Odds ratio (95% CI), p-value for all the outcomes.|Odds Ratio (OR)|1.01||||0.98|TWO_SIDED|95.0|0.7|1.38||Adjusted models controlled for cluster, village strata, village type, caste, household literacy status, stratum (individual-level data endline) and poor learning environment at school, school dropout, and marriage (cluster-level summaries baseline)|Regression, Logistic|Mixed-effects||||1.38|0.7|0.98
72412285|NCT03855189|144332663|OTHER|||||||0.39|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||0.39
72547885|NCT02761980|144624662|SUPERIORITY|Treatment difference and 95 % CI were based on LSM from ANCOVA with treatment, and covariates time from the first RSE full dose to randomization, and baseline temperature.|LSM difference|1.87|||<|0.001|TWO_SIDED|95.0|0.86|2.88|||ANCOVA|||WSTD 0-4 hours||2.88|0.86|< 0.001
72581503|NCT01996241|144692980|OTHER||Odds Ratio (OR)|1.0||||0.98|TWO_SIDED|95.0|0.7|1.4||Adjusted models controlled for cluster, village strata, village type, caste, household literacy status, stratum (individual-level data endline) and poor learning environment at school, school dropout, and marriage (cluster-level summaries baseline)|Regression, Logistic|Mixed-effects||||1.4|0.7|0.98
72581504|NCT01996241|144692981|OTHER||Odds Ratio (OR)|1.32||||0.331|TWO_SIDED|95.0|0.2|2.31||Adjusted for village strata and cluster, village type, caste, household literacy status, stratum using individual-level data and poor learning environment at school, school dropout, and marriage (in the form of cluster-level summaries).|Regression, Logistic|Mixed-effects||||2.31|0.2|0.331
72581505|NCT01996241|144692982|OTHER||Odds Ratio (OR)|0.83||||0.26|TWO_SIDED|95.0|0.6|1.15||Adjusted models controlled for cluster, village strata, village type, caste, household literacy status, stratum (individual-level data endline) and poor learning environment at school, school dropout, and marriage (cluster-level summaries baseline)|Regression, Logistic|Mixed-effects||||1.15|0.6|0.26
72581506|NCT01996241|144692983|OTHER||Odds Ratio (OR)|1.05||||0.79|TWO_SIDED|95.0|0.7|1.55||Adjusted models controlled for cluster, village strata, village type, caste, household literacy status, stratum (individual-level data endline) and poor learning environment at school, school dropout, and marriage (cluster-level summaries baseline)|Regression, Logistic|Mixed-effects||||1.55|0.7|0.79
72581507|NCT01996241|144692984|OTHER||Odds Ratio (OR)|0.83||||0.45|TWO_SIDED|95.0|0.5|1.34||Adjusted models controlled for cluster, village strata, village type, caste, household literacy status, stratum (individual-level data endline) and poor learning environment at school, school dropout, and marriage (cluster-level summaries baseline)|Regression, Logistic|Mixed-effects||||1.34|0.5|0.45
72412286|NCT03855189|144332664|OTHER||||||<|0.01|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||<0.01
72412287|NCT03855189|144332664|OTHER||||||<|0.01|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||<0.01
72581508|NCT03052751|144693009|SUPERIORITY||LS Mean Difference vs Placebo|-0.7|||=|0.221|ONE_SIDED|95.0||0.8||One-sided p-value was presented for difference.|MMRM||Estimate included treatment and treatment by visit interaction effects.|"Mixed Model Repeated Measures (MMRM) Analysis of Covariance (ANCOVA) model included fixed terms for treatment group, visit, interaction between treatment group and visit, covariate of Baseline QMG score, and random effect for participant.~The differences presented was 'UCB7665 (7 mg/kg) minus Placebo'."||0.8||=0.221
72581509|NCT03052751|144693010|SUPERIORITY||LS Mean Difference vs Placebo|-1.8|||=|0.089|ONE_SIDED|95.0||0.4||One-sided p-value was presented for difference.|MMRM||Estimate included treatment and treatment by visit interaction effects.|"MMRM ANCOVA model included fixed terms for treatment group, visit, interaction between treatment group and visit, covariate of Baseline MG-composite score, and random effect for participant.~The differences presented was 'UCB7665 (7 mg/kg) minus Placebo'."||0.4||=0.089
72581510|NCT03052751|144693011|SUPERIORITY||LS Mean Difference vs Placebo|-1.4|||=|0.036|ONE_SIDED|95.0||-0.1||One-sided p-value was presented for difference.|ANCOVA||Estimate included treatment effect.|ANCOVA model included fixed terms for treatment group, covariate of Baseline MGADL score.||-0.1||=0.036
72581511|NCT01634048|144693026|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<0.05
72581512|NCT02719184|144693031|OTHER|The analysis was based on a Mixed Model for Repeated Measures (MMRM) approach with diagnosis group-by-visit and baseline ALD value-by-visit terms, and unstructured covariance matrix structure for repeated measurements within subject.|Adjusted mean difference|-2.89|STANDARD_ERROR_OF_MEAN|1.23||0.0202|TWO_SIDED|95.0|-5.32|-0.45|||Mixed Model for Repeated Measures (MMRM)||The mean difference was calculated as value from COPD GOLD I group - value from Healthy subjects group.|||-0.45|-5.32|0.0202
72581513|NCT02719184|144693031|OTHER|The analysis was based on a Mixed Model for Repeated Measures (MMRM) approach with diagnosis group-by-visit and baseline ALD value-by-visit terms, and unstructured covariance matrix structure for repeated measurements within subject.|Adjusted mean difference|-4.78|STANDARD_ERROR_OF_MEAN|1.31||0.0003|TWO_SIDED|95.0|-7.36|-2.19|||Mixed Model for Repeated Measures (MMRM)||The mean difference was calculated as value from COPD GOLD II group - value from Healthy subjects group.|||-2.19|-7.36|0.0003
72581514|NCT02719184|144693031|OTHER|The analysis was based on a Mixed Model for Repeated Measures (MMRM) approach with diagnosis group-by-visit and baseline ALD value-by-visit terms, and unstructured covariance matrix structure for repeated measurements within subject.|Adjusted mean difference|-4.47|STANDARD_ERROR_OF_MEAN|1.51||0.0033|TWO_SIDED|95.0|-7.44|-1.5|||Mixed Model for Repeated Measures (MMRM)||The mean difference was calculated as value from COPD GOLD III group - value from Healthy subjects group.|||-1.50|-7.44|0.0033
72581515|NCT02719184|144693031|OTHER|The analysis was based on a Mixed Model for Repeated Measures (MMRM) approach with diagnosis group-by-visit and baseline ALD value-by-visit terms, and unstructured covariance matrix structure for repeated measurements within subject.|Adjusted mean difference|-5.86|STANDARD_ERROR_OF_MEAN|2.74||0.0334|TWO_SIDED|95.0|-11.26|-0.47|||Mixed Model for Repeated Measures (MMRM)||The mean difference was calculated as value from COPD and A1AT group - value from Healthy subjects group.|||-0.47|-11.26|0.0334
72581516|NCT02719184|144693032|OTHER|A random slope and intercept model with fixed categorical effects of diagnosis group, fixed continuous effects of time, and including diagnosis group-by-time interaction was applied. Random effect was included for subject specific intercept and time. Within-subject errors are modelled by an unstructured variance-covariance matrix.|Unadjusted mean difference|1.3|STANDARD_ERROR_OF_MEAN|14.4||0.9306|TWO_SIDED|95.0|-27.2|29.7|||Random slope and intercept model||The mean difference was calculated as value from COPD GOLD I group - value from Healthy subjects group.|||29.7|-27.2|0.9306
72581517|NCT02719184|144693032|OTHER|A random slope and intercept model with fixed categorical effects of diagnosis group, fixed continuous effects of time, and including diagnosis group-by-time interaction was applied. Random effect was included for subject specific intercept and time. Within-subject errors are modelled by an unstructured variance-covariance matrix.|Unadjusted mean difference|-19.2|STANDARD_ERROR_OF_MEAN|14.9||0.1983|TWO_SIDED|95.0|-48.5|10.1|||Random slope and intercept model|The mean difference was calculated as value from COPD GOLD II group - value from Healthy subjects group.||||10.1|-48.5|0.1983
72581518|NCT02719184|144693032|OTHER|A random slope and intercept model with fixed categorical effects of diagnosis group, fixed continuous effects of time, and including diagnosis group-by-time interaction was applied. Random effect was included for subject specific intercept and time. Within-subject errors are modelled by an unstructured variance-covariance matrix.|Unadjusted mean difference|-33.6|STANDARD_ERROR_OF_MEAN|16.1||0.0381|TWO_SIDED|95.0|-65.4|-1.9|||Random slope and intercept model||The mean difference was calculated as value from COPD GOLD III group - value from Healthy subjects group.|||-1.9|-65.4|0.0381
72581519|NCT02719184|144693032|OTHER|A random slope and intercept model with fixed categorical effects of diagnosis group, fixed continuous effects of time, and including diagnosis group-by-time interaction was applied. Random effect was included for subject specific intercept and time. Within-subject errors are modelled by an unstructured variance-covariance matrix.|Unadjusted mean difference|-61.8|STANDARD_ERROR_OF_MEAN|30.3||0.0419|TWO_SIDED|95.0|-121.3|-2.3|||Random slope and intercept model||The mean difference was calculated as value from COPD and A1AT group - value from Healthy subjects group.|||-2.3|-121.3|0.0419
72581520|NCT01111318|144693043|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability|Geometric mean ratio|123.15|STANDARD_DEVIATION|29.0|||TWO_SIDED|90.0|98.89|153.36|||ANOVA|Based on ANOVA with fixed effect for treatment (corresponding to hepatic impairment status).|Standard deviation is actually the geometric coefficient of variation|Ratio calculated as mild divided by healthy||153.36|98.89|
72412288|NCT03855189|144332664|OTHER|||||||0.6|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||0.60
72581521|NCT01111318|144693043|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability|Geometric mean ratio|146.97|STANDARD_DEVIATION|29.0|||TWO_SIDED|90.0|118.02|183.02|||ANOVA|Based on ANOVA with fixed effect for treatment (corresponding to hepatic impairment status).|Standard deviation is actually the geometric coefficient of variation|Ratio calculated as moderate divided by healthy||183.02|118.02|
72581522|NCT01111318|144693043|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability|Geometric mean ratio|174.7|STANDARD_DEVIATION|29.0|||TWO_SIDED|90.0|140.29|217.55|||ANOVA|Based on ANOVA with fixed effect for treatment (corresponding to hepatic impairment status).|Standard deviation is actually the geometric coefficient of variation|Ratio calculated as severe divided by healthy||217.55|140.29|
72581523|NCT01111318|144693044|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability|Geometric mean ratio|103.81|STANDARD_DEVIATION|30.7|||TWO_SIDED|90.0|82.29|130.95|||ANOVA|Based on ANOVA with fixed effect for treatment (corresponding to hepatic impairment status).|Standard deviation is actually the geometric coefficient of variation|Ratio calculated as mild divided by healthy||130.95|82.29|
72581524|NCT01111318|144693044|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability|Geometric mean ratio|123.31|STANDARD_DEVIATION|30.7|||TWO_SIDED|90.0|97.74|155.55|||ANOVA|Based on ANOVA with fixed effect for treatment (corresponding to hepatic impairment status).|Standard deviation is actually the geometric coefficient of variation|Ratio calculated as moderate divided by healthy||155.55|97.74|
72581525|NCT01111318|144693044|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability|Geometric mean ratio|148.41|STANDARD_DEVIATION|30.7|||TWO_SIDED|90.0|117.65|187.23|||ANOVA|Based on ANOVA with fixed effect for treatment (corresponding to hepatic impairment status).|Standard deviation is actually the geometric coefficient of variation|Ratio calculated as severe divided by healthy||187.23|117.65|
72581526|NCT02091856|144693057|SUPERIORITY_OR_OTHER||||||<|0.001||||||The a priori threshold for statistical significance was set at .05|ANOVA|Changes in primary outcome measures were evaluated using repeated measures ANOVA for three groups: C-CBT, R-CBT, WLCG and two time points: pre \& post||It was hypothesized that regardless of the CBT version received (conventional or religious), those in the active treatments would achieve a greater reduction in depressive and associated symptoms than participants in the wait-list condition.||||<0.001
72581527|NCT02091856|144693058|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||The a priori threshold for statistical significance was set at .05|ANOVA|Changes in secondary outcome measures were evaluated using repeated measures ANOVA (C-CBT, R-CBT, WLCG at pre- and post-intervention).||||||>0.05
72412289|NCT03855189|144332665|OTHER|||||||0.03|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||0.03
72412290|NCT03855189|144332665|OTHER|||||||0.01|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||0.01
72412291|NCT03855189|144332665|OTHER|||||||0.54|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||0.54
72412292|NCT03855189|144332666|OTHER||||||<|0.01|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||<0.01
72412293|NCT03855189|144332666|OTHER|||||||0.01|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||0.01
72412294|NCT03855189|144332666|OTHER|||||||0.71|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||0.71
72412295|NCT03855189|144332667|OTHER||||||<|0.01|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||<0.01
72412296|NCT03855189|144332667|OTHER||||||<|0.01|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||<0.01
72547886|NCT02761980|144624662|SUPERIORITY|Treatment difference and 95 % CI were based on LSM from ANCOVA with treatment, and covariates time from the first RSE full dose to randomization, and baseline temperature.|LSM difference|0.61||||0.094|TWO_SIDED|95.0|-0.1|1.33|||ANCOVA|||WSTD 0-4 hours||1.33|-0.10|0.094
72547887|NCT02761980|144624662|SUPERIORITY|Treatment difference and 95 % CI were based on LSM from ANCOVA with treatment, and covariates time from the first RSE full dose to randomization, and baseline temperature.|LSM difference|0.45||||0.217|TWO_SIDED|95.0|-0.27|1.17|||ANCOVA|||WSTD 0-4 hours||1.17|-0.27|0.217
72547888|NCT02761980|144624662|SUPERIORITY||LSM difference|1.26||||0.015|TWO_SIDED|95.0|0.24|2.27||Treatment difference and 95 % CI were based on LSM from ANCOVA with treatment, and covariates time from the first RSE full dose to randomization, and baseline temperature.|ANCOVA|||WSTD 0-4 hours||2.27|0.24|0.015
72581528|NCT02091856|144693059|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED|||||The a priori threshold for statistical significance was set at .05|ANOVA|||||||<0.01
72581529|NCT02091856|144693060|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||The a priori threshold for statistical significance was set at .05|ANOVA|||||||<0.001
72412297|NCT03855189|144332667|OTHER|||||||0.77|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||0.77
72412298|NCT03855189|144332668|OTHER|||||||0.11|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||0.11
72412299|NCT03855189|144332668|OTHER|||||||0.03|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||0.03
72412300|NCT03855189|144332668|OTHER|||||||0.6|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||0.60
72412301|NCT03855189|144332669|OTHER||||||<|0.01|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||<0.01
72412302|NCT03855189|144332669|OTHER||||||<|0.01|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||<0.01
72412303|NCT03855189|144332669|OTHER|||||||0.59|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||0.59
72412304|NCT03855189|144332670|OTHER|||||||0.07|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||0.07
72412305|NCT03855189|144332670|OTHER|||||||0.01|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||0.01
72412306|NCT03855189|144332670|OTHER|||||||0.43|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||0.43
72412307|NCT03855189|144332671|OTHER|||||||0.09|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||0.09
72412308|NCT03855189|144332671|OTHER|||||||0.08|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||0.08
72412309|NCT03855189|144332671|OTHER|||||||0.96|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||0.96
72412310|NCT03855189|144332672|OTHER|||||||0.01|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||0.01
72412311|NCT03855189|144332672|OTHER||||||<|0.01|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||<0.01
72412312|NCT03855189|144332672|OTHER|||||||0.64|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||0.64
72412313|NCT03855189|144332673|OTHER|||||||0.25|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||0.25
72412314|NCT03855189|144332673|OTHER|||||||0.02|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||0.02
72412315|NCT03855189|144332673|OTHER|||||||0.26|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||0.26
72547889|NCT02761980|144624662|SUPERIORITY|Treatment difference and 95 % CI were based on LSM from ANCOVA with treatment, and covariates time from the first RSE full dose to randomization, and baseline temperature.|LSM difference|1.42||||0.006|TWO_SIDED|95.0|0.4|2.44|||ANCOVA|||WSTD 0-4 hours||2.44|0.40|0.006
72547890|NCT02761980|144624662|SUPERIORITY|Treatment difference and 95 % CI were based on LSM from ANCOVA with treatment, and covariates time from the first RSE full dose to randomization, and baseline temperature.|LSM difference|-0.16||||0.659|TWO_SIDED|95.0|-0.87|0.55|||ANCOVA|||WSTD 0-4 hours||0.55|-0.87|0.659
72581530|NCT02091856|144693061|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED|||||The a priori threshold for statistical significance was set at .05|t-test, 1 sided|||||||<0.01
72581531|NCT00725491|144693083|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||Cochran-Whitehead|||||||<0.001
72581532|NCT01495000|144693084|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.05|||<|0.0001|TWO_SIDED|95.0|1.91|4.19|||ANCOVA|||||4.19|1.91|<0.0001
72581533|NCT02002221|144693164|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.91|STANDARD_ERROR_OF_MEAN|0.09|<|0.001|TWO_SIDED|95.0|-1.08|-0.73|||ANCOVA|||H0: δ vildagliptin 50 mg bid = δ placebo versus H1: δ Vildagliptin 50 mg bid \< δ placebo,||-0.73|-1.08|< 0.001
72412316|NCT03855189|144332674|OTHER||||||<|0.01|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||<0.01
72412317|NCT03855189|144332674|OTHER||||||<|0.01|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||<0.01
72412318|NCT03855189|144332674|OTHER|||||||0.09|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||0.09
72412319|NCT03855189|144332675|OTHER|||||||0.05|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||0.05
72547891|NCT02761980|144624662|SUPERIORITY|Treatment difference and 95 % CI were based on LSM from ANCOVA with treatment, and covariates time from the first RSE full dose to randomization, and baseline temperature.|LSM difference|2.62|||<|0.001|TWO_SIDED|95.0|1.16|4.08|||ANCOVA|||WSTD 0-6 hours||4.08|1.16|< 0.001
72547892|NCT02761980|144624662|SUPERIORITY|Treatment difference and 95 % CI were based on LSM from ANCOVA with treatment, and covariates time from the first RSE full dose to randomization, and baseline temperature.|LSM difference|0.79||||0.135|TWO_SIDED|95.0|-0.25|1.82|||ANCOVA|||WSTD 0-6 hours||1.82|-0.25|0.135
72547893|NCT02761980|144624662|SUPERIORITY|Treatment difference and 95 % CI were based on LSM from ANCOVA with treatment, and covariates time from the first RSE full dose to randomization, and baseline temperature.|LSM difference|0.7||||0.186|TWO_SIDED|95.0|-0.34|1.74|||ANCOVA|||WSTD 0-6 hours||1.74|-0.34|0.186
72547894|NCT02761980|144624662|SUPERIORITY|Treatment difference and 95 % CI were based on LSM from ANCOVA with treatment, and covariates time from the first RSE full dose to randomization, and baseline temperature.|LSM difference|1.83||||0.014|TWO_SIDED|95.0|0.37|3.29|||ANCOVA|||WSTD 0-6 hours||3.29|0.37|0.014
72547895|NCT02761980|144624662|SUPERIORITY|Treatment difference and 95 % CI were based on LSM from ANCOVA with treatment, and covariates time from the first RSE full dose to randomization, and baseline temperature.|LSM difference|1.92||||0.011|TWO_SIDED|95.0|0.45|3.39|||ANCOVA|||WSTD 0-6 hours||3.39|0.45|0.011
72547896|NCT02761980|144624662|SUPERIORITY|Treatment difference and 95 % CI were based on LSM from ANCOVA with treatment, and covariates time from the first RSE full dose to randomization, and baseline temperature.|LSM difference|-0.09||||0.865|TWO_SIDED|95.0|-1.12|0.94|||ANCOVA|||WSTD 0-6 hours||0.94|-1.12|0.865
72547897|NCT02761980|144624663|SUPERIORITY|||||||0.449||||||Generalized log-rank test based on interval-censored survival analysis using nonparametric survival method.|Log Rank|||||||0.449
72547898|NCT02761980|144624663|SUPERIORITY|||||||0.142||||||Generalized log-rank test based on interval-censored survival analysis using nonparametric survival method.|Log Rank|||||||0.142
72581534|NCT01518322|144693188|SUPERIORITY_OR_OTHER||Kappa Statistics|0.049|||||TWO_SIDED|95.0|-0.0895|0.1875||||||Kappa statistics were used to determine the level of agreement between FeNO measurements and asthma diagnosis using the a dichotomous schemes a measurement greater than 35 ppb for children under the age of 12 years or greater than 50 ppb for subjects at least 12 years of age was considered high.||0.1875|-0.0895|
72581535|NCT02792517|144693226|OTHER||Least Squares Geometric Mean Ratio|1.04|||||TWO_SIDED|90.0|0.88|1.22|||||Ratio of EE/norgestimate + erenumab to EE/norgestimate alone|The log-transformed Cmax was analyzed using a linear mixed effects model with treatment as a fixed effect and subject as a random effect.||1.22|0.88|
72581536|NCT02792517|144693227|OTHER||Least Squares Geometric Mean Ratio|1.02|||||TWO_SIDED|90.0|0.91|1.14|||||Ratio of EE/norgestimate + erenumab to EE/norgestimate alone|The log-transformed AUCtau was analyzed using a linear mixed effects model with treatment as a fixed effect and subject as a random effect.||1.14|0.91|
72581537|NCT02792517|144693228|OTHER||Least Squares Geometric Mean Ratio|1.06|||||TWO_SIDED|90.0|0.97|1.16|||||Ratio of EE/norgestimate + erenumab to EE/norgestimate alone|The log-transformed Cmax was analyzed using a linear mixed effects model with treatment as a fixed effect and subject as a random effect.||1.16|0.97|
72581538|NCT02792517|144693229|OTHER||Least Squares Geometric Mean Ratio|1.03|||||TWO_SIDED|90.0|0.96|1.1|||||Ratio of EE/norgestimate + erenumab to EE/norgestimate alone|The log-transformed AUCtau was analyzed using a linear mixed effects model with treatment as a fixed effect and subject as a random effect.||1.10|0.96|
72581539|NCT02792517|144693230|OTHER||Least Squares Geometric Mean Ratio|1.05|||||TWO_SIDED|90.0|0.9|1.23|||||Ratio of EE/norgestimate + erenumab to EE/norgestimate alone|The log-transformed Cmax was analyzed using a linear mixed effects model with treatment as a fixed effect and subject as a random effect.||1.23|0.90|
72581540|NCT02792517|144693231|OTHER||Least Squares Geometric Mean Ratio|1.02|||||TWO_SIDED|90.0|0.94|1.12|||||Ratio of EE/norgestimate + erenumab to EE/norgestimate alone|The log-transformed AUCtau was analyzed using a linear mixed effects model with treatment as a fixed effect and subject as a random effect.||1.12|0.94|
72581541|NCT04583735|144693280|SUPERIORITY||LSMean difference|-1.48|STANDARD_ERROR_OF_MEAN|0.396||0.0004|TWO_SIDED|95.0|-2.28|-0.69||MMRM analysis with an unstructured variance-covariance matrix including change from Baseline value as dependent variable \& covariates: Baseline value, treatment group, visit, visit-by-treatment \& visit-by-Baseline value interactions.|MMRM|||||-0.69|-2.28|0.0004
72581542|NCT02015611|144693308|SUPERIORITY|||||||0.63|||||||ANCOVA|adjusted for age, sex, race, season (time-varying)||||||0.63
72581543|NCT02015611|144693309|SUPERIORITY|||||||0.64|||||||Regression, Linear|adjusted for age, sex, race, season, and baseline value||||||0.64
72581544|NCT02015611|144693310|SUPERIORITY|||||||0.08|||||||ANCOVA|adjusted for age, sex, race, season (time-varying)||||||0.08
72581545|NCT02015611|144693311|SUPERIORITY|||||||0.53|||||||ANCOVA|adjusted for age, sex, race, season (time-varying)||||||0.53
72581546|NCT02015611|144693312|SUPERIORITY|||||||0.75|||||||ANCOVA|adjusted for age, sex, race, season (time-varying)||||||0.75
72581547|NCT02015611|144693313|SUPERIORITY|||||||0.92|||||||ANCOVA|adjusted for age, sex, race, season (time-varying)||||||0.92
72581548|NCT02015611|144693314|SUPERIORITY|||||||0.94|||||||ANCOVA|adjusted for age, sex, race, season (time-varying)||||||0.94
72581549|NCT02015611|144693315|SUPERIORITY|||||||0.61|||||||ANCOVA|adjusted for age, sex, race, season (time-varying)||||||0.61
72581550|NCT02015611|144693316|SUPERIORITY|||||||0.59|||||||ANCOVA|adjusted for age, sex, race, season (time-varying)||||||0.59
72581551|NCT02015611|144693317|SUPERIORITY|||||||0.21|||||||ANCOVA|adjusted for age, sex, race, season (time-varying)||||||0.21
72581552|NCT03737357|144693376|NON_INFERIORITY|The tolerance range or non-inferiority margin characterizes the largest absolute difference which is considered to be dismissible. A MBL of less than 0.5mm within the first year after implant loading constitutes an acceptable clinical standard(10, 18, 19). In this clinical trial, a non-inferiority margin of 20% of the acceptable clinical standard was chosen, which amounts to 0.1mm.|paired difference|0.01||||0.074|TWO_SIDED||||||t-test, 1 sided|Non-inferiority one-sided paired t-tests using a non-inferiority margin of -0.10mm.|The paired difference is (SLActive® bone level change from baseline (CFB) - SLA® CFB (i.e. resorption))||In the PP population, the paired difference between SLActive® and SLA® bone level change from baseline (CFB) was estimated at 0.01 mm with a standard deviation of 0.444 mm (95% CI: -Inf, 0.11; p = 0.074), based on a one-sided paired t-test with a non-inferiority margin of 0.10 mm.|||0.074
72547899|NCT02761980|144624663|SUPERIORITY|||||||0.822||||||Generalized log-rank test based on interval-censored survival analysis using nonparametric survival method.|Log Rank|||||||0.822
72547900|NCT02761980|144624663|SUPERIORITY|||||||0.671||||||Generalized log-rank test based on interval-censored survival analysis using nonparametric survival method.|Log Rank|||||||0.671
72581553|NCT01320293|144693386|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 1 sided|||Null hypothesis: Percent change in endothelial function from baseline visit to end of treatment/month 6 will be zero change. (percent change=0)||||<0.05
72581554|NCT01320293|144693387|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 1 sided|||Null hypothesis: change in IL-6 levels from baseline visit to end of treatment/month 6 will be zero change. (percent change=0)||||<0.05
72581555|NCT01320293|144693388|SUPERIORITY_OR_OTHER|||||||0.05|||||||t-test, 1 sided|||Null hypothesis: change in adiponectin levels from baseline visit to end of treatment/month 6 will be zero change. (percent change=0)||||0.05
72581556|NCT02586155|144693403|SUPERIORITY||Cox Proportional Hazard|0.823||||0.107|TWO_SIDED|95.0|0.649|1.044|||Stratified long-rank|||||1.044|0.649|0.1070
72581557|NCT02586155|144693404|SUPERIORITY||Cox Proportional Hazard|0.849||||0.1495|TWO_SIDED|95.0|0.679|1.061|||Stratified long-rank|||||1.061|0.679|0.1495
72581558|NCT02586155|144693405|SUPERIORITY||Hazard Ratio (HR)|0.59||||0.03|TWO_SIDED|95.0|0.38|0.94|||Stratified long-rank|||||0.94|0.38|0.03
72581559|NCT02586155|144693406|SUPERIORITY||Hazard Ratio (HR)|0.88||||0.44|TWO_SIDED|95.0|0.62|1.24|||Stratified long-rank|||||1.24|0.62|0.44
72581560|NCT02586155|144693417|SUPERIORITY||Cox Proportional Hazard|0.78||||0.03|TWO_SIDED|95.0|0.63|0.98|||Log Rank|||||0.98|0.63|0.03
72581561|NCT02456740|144693423|SUPERIORITY|The primary endpoint was tested independently for each erenumab dose at an alpha level of 0.04 for 70 mg and of 0.01 for 140 mg to maintain the type 1 error rate at an alpha level of 0.05.|LS Mean Difference|-1.4|||<|0.001|TWO_SIDED|95.0|-1.88|-0.92|||Generalized Linear Mixed Model|||The primary endpoint was analyzed using a generalized linear mixed model which includes treatment, visit, treatment by visit interaction, stratification factors (region and prior/current treatment with migraine prophylactic medication), and baseline value as covariates.||-0.92|-1.88|< 0.001
72581562|NCT02456740|144693423|SUPERIORITY|The primary endpoint was tested independently for each erenumab dose at an alpha level of 0.04 for 70 mg and of 0.01 for 140 mg to maintain the type 1 error rate at an alpha level of 0.05.|LS Mean Difference|-1.85|||<|0.001|TWO_SIDED|95.0|-2.33|-1.37|||Generalized Linear Mixed Model|||The primary endpoint was analyzed using a generalized linear mixed model which includes treatment, visit, treatment by visit interaction, stratification factors (region and prior/current treatment with migraine prophylactic medication), and baseline value as covariates.||-1.37|-2.33|< 0.001
72581563|NCT02456740|144693424|SUPERIORITY|If the primary endpoint was statistically significant for the erenumab 70 mg group, using a gate-keeping strategy, the first two (first tier) secondary endpoints were tested using the Hochberg method at an alpha level of 0.04.|Odds Ratio (OR)|2.13|||<|0.001|TWO_SIDED|95.0|1.52|2.98|||Cochran-Mantel-Haenszel|||Analyzed using a Cochran-Mantel-Haenszel test, stratified by the randomization stratification factors (region and prior/current treatment with migraine prophylactic medication).||2.98|1.52|< 0.001
72581564|NCT02456740|144693424|SUPERIORITY|If the primary endpoint was statistically significant for the erenumab 140 mg group, using a gate-keeping strategy, the first two (first tier) secondary endpoints were tested using the Hochberg method at an alpha level of 0.01.|Odds Ratio (OR)|2.81|||<|0.001|TWO_SIDED|95.0|2.01|3.94|||Cochran-Mantel-Haenszel|||Analyzed using a Cochran-Mantel-Haenszel test, stratified by the randomization stratification factors (region and prior/current treatment with migraine prophylactic medication).||3.94|2.01|< 0.001
72581565|NCT02456740|144693425|SUPERIORITY|If the primary endpoint was statistically significant for the erenumab 70 mg group, using a gate-keeping strategy, the first two (first tier) secondary endpoints were tested using the Hochberg method at an alpha level of 0.04.|LS Mean Difference|-0.94|||<|0.001|TWO_SIDED|95.0|-1.23|-0.64|||Generalized Linear Mixed Model|||Analyzed using a generalized linear mixed model which includes treatment, visit, treatment by visit interaction, stratification factors (region and prior/current treatment with migraine prophylactic medication), and baseline value as covariates.||-0.64|-1.23|< 0.001
72581566|NCT02456740|144693425|SUPERIORITY|If the primary endpoint was statistically significant for the erenumab 140 mg group, using a gate-keeping strategy, the first two (first tier) secondary endpoints were tested using the Hochberg method at an alpha level of 0.01.|LS Mean Difference|-1.42|||<|0.001|TWO_SIDED|95.0|-1.71|-1.12|||Generalized Linear Mixed Model|||Analyzed using a generalized linear mixed model which includes treatment, visit, treatment by visit interaction, (stratification factors region and prior/current treatment with migraine prophylactic medication), and baseline value as covariates.||-1.12|-1.71|< 0.001
72412320|NCT03855189|144332675|OTHER||||||<|0.01|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||<0.01
72412321|NCT03855189|144332675|OTHER|||||||0.07|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||0.07
72547901|NCT02761980|144624663|SUPERIORITY|||||||0.514||||||Generalized log-rank test based on interval-censored survival analysis using nonparametric survival method.|Log Rank|||||||0.514
72547902|NCT02761980|144624663|SUPERIORITY|||||||0.191||||||Generalized log-rank test based on interval-censored survival analysis using nonparametric survival method.|Log Rank|||||||0.191
72547903|NCT02761980|144624664|SUPERIORITY|||||||0.997||||||P-value, hazard ratio (HR) and corresponding 95% CI were calculated based on the proportional hazards (PH) model with treatment term in the model.|hazard ratio|||||||0.997
72547904|NCT02761980|144624664|SUPERIORITY|||||||0.998||||||P-value, HR and corresponding 95% CI were calculated based on the PH model with treatment term in the model.|Hazard Ratio|||||||0.998
72581567|NCT02456740|144693426|SUPERIORITY|If the first tier secondary endpoints were statistically significant for both erenumab doses the erenumab 140 mg group for the 2 remaining MPFID secondary endpoints was tested using the Hochberg method at a level of 0.05; If only the erenumab 70 mg group or 140 mg group showed statistical significance for the first tier secondary endpoints then the erenumab 140 group for the 2 remaining MPFID secondary endpoints was tested for significance at a level of either 0.04 or 0.01 respectively.|LS Mean Difference|-2.43|||<|0.001|TWO_SIDED|95.0|-3.51|-1.35|||Generalized Linear Mixed Model|||Analyzed using a generalized linear mixed model which includes treatment, visit, treatment by visit interaction, stratification factors (region and prior/current treatment with migraine prophylactic medication), and baseline value as covariates.||-1.35|-3.51|< 0.001
72412322|NCT03855189|144332676|OTHER|||||||0.04|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||0.04
72581568|NCT02456740|144693426|SUPERIORITY|If the erenumab 140 mg group for both remaining MPFID secondary endpoints were statistically significant, then the erenumab 70 mg group for the two remaining MPFID secondary endpoints was tested for significance using the Hochberg method with the same alpha level carried over from 140 mg group.|LS Mean Difference|-1.86|||<|0.001|TWO_SIDED|95.0|-2.95|-0.77|||Generalized Linear Mixed Model|||Analyzed using a generalized linear mixed model which includes treatment, visit, treatment by visit interaction, stratification factors (region and prior/current treatment with migraine prophylactic medication), and baseline value as covariates.||-0.77|-2.95|< 0.001
72412323|NCT03855189|144332676|OTHER|||||||0.01|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||0.01
72581569|NCT02456740|144693427|SUPERIORITY|If the first tier secondary endpoints were statistically significant for both erenumab doses the erenumab 140 mg group for the 2 remaining MPFID secondary endpoints was tested using the Hochberg method at a level of 0.05; If only the erenumab 70 mg group or 140 mg group showed statistical significance for the first tier secondary endpoints then the erenumab 140 group for the 2 remaining MPFID secondary endpoints was tested for significance at a level of either 0.04 or 0.01 respectively.|LS Mean Difference|-2.57|||<|0.001|TWO_SIDED|95.0|-3.62|-1.51|||Generalized Linear Mixed Model|||Analyzed using a generalized linear mixed model which includes treatment, visit, treatment by visit interaction, stratification factors (region and prior/current treatment with migraine prophylactic medication), and baseline value as covariates.||-1.51|-3.62|< 0.001
72581570|NCT02456740|144693427|SUPERIORITY|If the erenumab 140 mg group for both remaining MPFID secondary endpoints were statistically significant, then the erenumab 70 mg group for the two remaining MPFID secondary endpoints was tested for significance using the Hochberg method with the same alpha level carried over from 140 mg group.|LS Mean Difference|-2.22|||<|0.001|TWO_SIDED|95.0|-3.28|-1.16|||Generalized Linear Mixed Model|||Analyzed using a generalized linear mixed model which includes treatment, visit, treatment by visit interaction, stratification factors (region and prior/current treatment with migraine prophylactic medication), and baseline value as covariates.||-1.16|-3.28|< 0.001
72581571|NCT02750618|144693465|SUPERIORITY||Least Squares Mean Difference|0.96|||<|0.0001|TWO_SIDED|95.0|0.73|1.19|||GEE model|||||1.19|0.73|< 0.0001
72581572|NCT02750618|144693467|SUPERIORITY||Difference in LS Means|2.21|||<|0.0001|TWO_SIDED|95.0|2.07|2.35|||GEE model|||||2.35|2.07|< 0.0001
72581573|NCT02750618|144693468|SUPERIORITY||Difference in LS Means|2.23|||<|0.0001|TWO_SIDED|95.0|2.01|2.45|||GEE model|||The GEE model includes the RGI-C score as the dependent variable, visit as a factor, age and RSS at baseline as covariates, with exchangeable covariance structure. The least squares (LS) mean, standard error (SE), 95% confidence interval (CI) and 2-sided p-value are from the GEE model.||2.45|2.01|< 0.0001
72581574|NCT02750618|144693469|SUPERIORITY||Difference in LS Means|-1.75|||<|0.0001|TWO_SIDED|95.0|-1.98|-1.53|||GEE model|||||-1.53|-1.98|< 0.0001
72581575|NCT02750618|144693470|SUPERIORITY||Difference in LS Means|-2.02|||<|0.0001|TWO_SIDED|95.0|-2.25|-1.8||The GEE model includes the change from baseline in RSS as the dependent variable, visit as a factor, age and RSS at baseline as covariates, with exchangeable covariance structure.|GEE model|||||-1.80|-2.25|< 0.0001
72581576|NCT02750618|144693471|SUPERIORITY||Difference in LS Means|1.21|||<|0.0001|TWO_SIDED|95.0|0.9|1.51|||GEE model|||||1.51|0.90|< 0.0001
72581577|NCT02750618|144693472|SUPERIORITY||Difference in LS Means|1.51|||<|0.0001|TWO_SIDED|95.0|1.27|1.76||The GEE model includes the RGI-C score as the dependent variable, visit as a factor, age and RSS at baseline as covariates, with exchangeable covariance structure. The LS Mean, SE, 95% CI and 2-sided p-value are from the GEE model.|GEE|||||1.76|1.27|< 0.0001
72581578|NCT02750618|144693476|SUPERIORITY||Difference in LS Means|-82.91||||0.0004|TWO_SIDED|95.0|-128.68|-37.15|||GEE model|||Week 4||-37.15|-128.68|0.0004
72581579|NCT02750618|144693476|SUPERIORITY||Difference in LS Means|-83.84||||0.064|TWO_SIDED|95.0|-172.55|4.88|||GEE model|||Week 12||4.88|-172.55|0.0640
72581580|NCT02750618|144693476|SUPERIORITY||Difference in LS Means|-161.38|||<|0.0001|TWO_SIDED|95.0|-186.7|-136.05|||GEE model|||Week 20||-136.05|-186.70|< 0.0001
72581581|NCT02750618|144693476|SUPERIORITY||Difference in LS Means|-214.99|||<|0.0001|TWO_SIDED|95.0|-241.7|-188.28|||GEE model|||Week 40||-188.28|-241.70|< 0.0001
72581582|NCT02750618|144693476|SUPERIORITY||Difference in LS Means|-226.58|||<|0.0001|TWO_SIDED|95.0|-249.11|-204.06|||GEE model|||Week 48||-204.06|-249.11|< 0.0001
72412324|NCT03855189|144332676|OTHER|||||||0.53|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||0.53
72581583|NCT02750618|144693476|SUPERIORITY||Difference in LS Means|-216.45|||<|0.0001|TWO_SIDED|95.0|-248.13|-184.77|||GEE model|||Week 56||-184.77|-248.13|< 0.0001
72581584|NCT02750618|144693476|SUPERIORITY||Difference in LS Means|-216.76|||<|0.0001|TWO_SIDED|95.0|-241.66|-191.86|||GEE model|||Week 64||-191.86|-241.66|< 0.0001
72581585|NCT02750618|144693476|SUPERIORITY||LS Mean|-231.22|||<|0.0001|TWO_SIDED|95.0|-262.51|-199.93|||GEE|||Week 76||-199.93|-262.51|< 0.0001
72581586|NCT02750618|144693476|SUPERIORITY||LS Mean|-237.78|||<|0.0001|TWO_SIDED|95.0|-262.94|-212.62|||GEE|||Week 88||-212.62|-262.94|< 0.0001
72581587|NCT02750618|144693476|SUPERIORITY||LS Mean|-218.14|||<|0.0001|TWO_SIDED|95.0|-248.21|-188.08|||GEE|||Week 100||-188.08|-248.21|< 0.0001
72581588|NCT02750618|144693476|SUPERIORITY||LS Mean|-233.91|||<|0.0001|TWO_SIDED|95.0|-255.66|-212.16|||GEE|||Week 112||-212.16|-255.66|< 0.0001
72581589|NCT02750618|144693476|SUPERIORITY||LS Mean|-252.22|||<|0.0001|TWO_SIDED|95.0|-268.51|-235.93|||GEE|||Week 124||-235.93|-268.51|< 0.0001
72581590|NCT02750618|144693476|SUPERIORITY||LS Mean|-267.89|||<|0.0001|TWO_SIDED|95.0|-293.61|-242.16|||GEE|||Week 136||-242.16|-293.61|< 0.0001
72581591|NCT02750618|144693476|SUPERIORITY||LS Mean|-248.05|||<|0.0001|TWO_SIDED|95.0|-272.85|-223.25|||GEE|||Week 148||-223.25|-272.85|< 0.0001
72581592|NCT02750618|144693476|SUPERIORITY||LS Mean|-248.47|||<|0.0001|TWO_SIDED|95.0|-270.01|-226.93|||GEE|||Week 160||-226.93|-270.01|< 0.0001
72581593|NCT01038336|144693478|SUPERIORITY_OR_OTHER|||||||0.289|TWO_SIDED||||||Chi-squared|||||||0.289
72581594|NCT01038336|144693479|SUPERIORITY_OR_OTHER|||||||0.004|TWO_SIDED||||||ANOVA|||||||0.004
72581595|NCT01038336|144693480|SUPERIORITY_OR_OTHER|||||||0.072|TWO_SIDED||||||ANOVA|||||||0.072
72547905|NCT02761980|144624664|SUPERIORITY|||||||0.997||||||P-value, HR and corresponding 95% CI were calculated based on the PH model with treatment term in the model.|Hazard Ratio|||||||0.997
72547906|NCT02761980|144624665|SUPERIORITY|Treatment difference and 95 % CI were based on LSM from ANCOVA with treatment, and covariates time from the first RSE full dose to randomization, and baseline temperature.|LSM difference|0.67||||0.101|TWO_SIDED|95.0|-0.13|1.48|||ANCOVA|||||1.48|-0.13|0.101
72547907|NCT02761980|144624665|SUPERIORITY|Treatment difference and 95 % CI were based on LSM from ANCOVA with treatment, and covariates time from the first RSE full dose to randomization, and baseline temperature.|LSM difference|0.16||||0.582|TWO_SIDED|95.0|-0.41|0.73|||ANCOVA|||||0.73|-0.41|0.582
72547908|NCT02761980|144624665|SUPERIORITY||LSM difference|0.15||||0.614|TWO_SIDED|95.0|-0.43|0.72|||ANCOVA|||Treatment difference and 95 % CI were based on LSM from ANCOVA with treatment, and covariates time from the first RSE full dose to randomization, and baseline temperature.||0.72|-0.43|0.614
72547909|NCT02761980|144624665|SUPERIORITY|Treatment difference and 95 % CI were based on LSM from ANCOVA with treatment, and covariates time from the first RSE full dose to randomization, and baseline temperature.|LSM difference|0.51||||0.212|TWO_SIDED|95.0|-0.29|1.32|||ANCOVA|||||1.32|-0.29|0.212
72412325|NCT03855189|144332677|OTHER|||||||0.02|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||0.02
72547910|NCT02761980|144624665|SUPERIORITY|Treatment difference and 95 % CI were based on LSM from ANCOVA with treatment, and covariates time from the first RSE full dose to randomization, and baseline temperature.|LSM difference|0.53||||0.202|TWO_SIDED|95.0|-0.28|1.34|||ANCOVA|||||1.34|-0.28|0.202
72547911|NCT02761980|144624665|SUPERIORITY|Treatment difference and 95 % CI were based on LSM from ANCOVA with treatment, and covariates time from the first RSE full dose to randomization, and baseline temperature.|LSM difference|-0.01||||0.965|TWO_SIDED|95.0|-0.58|0.55|||ANCOVA|||||0.55|-0.58|0.965
72547912|NCT00101582|144624667|SUPERIORITY_OR_OTHER||Chi-Square Statistic|4.1764||||0.041||95.0||||Generalized Cochran-Mantel-Haenszel test for general association. Participants having no assessment were assumed as having WHO grade 3 or 4 oral mucositis in hypothesis testing.|Cochran-Mantel-Haenszel|Stratified by disease stage (III versus IV) and primary anatomical tumor location (oral cavity / oropharynx vs. nasopharynx vs. hypopharynx / larynx).||Sample size calculations were based on the number of participants needed to detect, with 90% power and 5% type 1 error rate, at least a 25% difference in the incidence of severe OM between the treatment groups. A 25% absolute reduction in the incidence of severe OM from the placebo group was considered by investigators as clinically meaningful in this clinical setting.||||0.0410
72547913|NCT00101582|144624668|SUPERIORITY_OR_OTHER||Chi-Square Statistic|5.8002||||0.016||95.0||||Generalized Cochran-Mantel-Haenszel test for mean score difference.|Cochran-Mantel-Haenszel|Stratified by disease stage (III versus IV) and primary anatomical tumor location (oral cavity / oropharynx vs. nasopharynx vs. hypopharynx / larynx).||||||0.0160
72547914|NCT00101582|144624668|SUPERIORITY_OR_OTHER|||||||0.1122||95.0||||Adjusted p-value was based on Hochberg procedure to control for the Type 1 error.|Cochran-Mantel-Haenszel|||To protect the overall type 1 error, the Hochberg procedure was used to adjust for multiple statistical testing of the secondary efficacy endpoints.||||0.1122
72547915|NCT00101582|144624669|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.6603||||0.0261|TWO_SIDED|95.0|0.4546|0.9592|||Stratified Log-Rank test|Stratified by disease stage (III versus IV) and primary anatomical tumor location (oral cavity / oropharynx vs. nasopharynx vs. hypopharynx / larynx).|Hazard ratio of palifermin over placebo based on Stratified Cox proportional hazard model.|||0.9592|0.4546|0.0261
72547916|NCT00101582|144624669|SUPERIORITY_OR_OTHER|||||||0.1566||95.0||||Adjusted p-value was based on Hochberg procedure to control for the Type 1 error.|Stratified Log-Rank test|||||||0.1566
72547917|NCT00101582|144624670|SUPERIORITY_OR_OTHER||Chi-Square Statistic|3.9715||||0.0463||95.0||||Generalized Cochran-Mantel-Haenszel test for general association. Participants having no assessment were assumed to have the event.|Cochran-Mantel-Haenszel|Stratified by disease stage (III versus IV) and primary anatomical tumor location (oral cavity / oropharynx vs. nasopharynx vs. hypopharynx / larynx).||||||0.0463
72547918|NCT00101582|144624670|SUPERIORITY_OR_OTHER|||||||0.2314||95.0||||Adjusted p-value was based on Hochberg procedure to control for the Type 1 error.|Cochran-Mantel-Haenszel|||||||0.2314
72547919|NCT00101582|144624671|SUPERIORITY_OR_OTHER||Chi-Square Statistic|3.2548||||0.0712||95.0||||Generalized Cochran-Mantel-Haenszel test for mean score difference using modified ridit score|Cochran-Mantel-Haenszel|Stratified by disease stage (III versus IV) and primary anatomical tumor location (oral cavity / oropharynx vs. nasopharynx vs. hypopharynx / larynx).||||||0.0712
72547920|NCT00101582|144624671|SUPERIORITY_OR_OTHER|||||||0.2849||95.0||||Adjusted p-value was based on Hochberg procedure to control for the Type 1 error.|Cochran-Mantel-Haenszel|||||||0.2849
72547921|NCT00101582|144624672|SUPERIORITY_OR_OTHER||Chi-Square Statistic|1.3901||||0.2384||95.0||||Generalized Cochran-Mantel-Haenszel test for mean score difference using modified ridit score.|Cochran-Mantel-Haenszel|Stratified by disease stage (III versus IV) and primary anatomical tumor location (oral cavity / oropharynx vs. nasopharynx vs. hypopharynx / larynx).||||||0.2384
72547922|NCT00101582|144624672|SUPERIORITY_OR_OTHER|||||||0.6835||95.0||||Adjusted p-value was based on Hochberg procedure to control for the Type 1 error.|Cochran-Mantel-Haenszel|||||||0.6835
72547923|NCT00101582|144624673|SUPERIORITY_OR_OTHER||Chi-Square Statistic|0.9039||||0.3417||95.0||||Generalized Cochran-Mantel-Haenszel test for general association|Cochran-Mantel-Haenszel|Stratified by disease stage (III versus IV) and primary anatomical tumor location (oral cavity / oropharynx vs. nasopharynx vs. hypopharynx / larynx).||||||0.3417
72547924|NCT00101582|144624673|SUPERIORITY_OR_OTHER|||||||0.6835||95.0||||Adjusted p-value was based on Hochberg procedure to control for the Type 1 error.|Cochran-Mantel-Haenszel|||||||0.6835
72547925|NCT00101582|144624674|SUPERIORITY_OR_OTHER||Chi-Square Statistic|0.0027||||0.9587||95.0||||Generalized Cochran-Mantel-Haenszel test for general association.|Cochran-Mantel-Haenszel|Stratified by disease stage (III versus IV) and primary anatomical tumor location (oral cavity / oropharynx vs. nasopharynx vs. hypopharynx / larynx).||||||0.9587
72547926|NCT00101582|144624674|SUPERIORITY_OR_OTHER|||||||0.9587||95.0||||Adjusted p-value was based on Hochberg procedure to control for the Type 1 error.|Cochran-Mantel-Haenszel|||||||0.9587
72547927|NCT03093324|144624694|SUPERIORITY||Rate ratio|0.542||||0.0003|TWO_SIDED|95.0|0.39|0.754|||Negative Binomial Regression Model|||Number of event days was analyzed by a negative binomial regression model, with the logarithmic transformation of the number of exposure days as the ''offset'' parameter and treatment group as a factor and adjusting for study part, region (US and non-US), age, and body mass index (BMI).||0.754|0.390|0.0003
72547928|NCT03093324|144624695|SUPERIORITY||Rate ratio|0.52||||0.0007|TWO_SIDED|95.0|0.356|0.76|||Negative Binomial Regression Model|||Number of event days was analyzed by a negative binomial regression model, with the logarithmic transformation of the number of exposure days as the ''offset'' parameter and treatment group as a factor and adjusting for study part, region (US and non-US), age, and body mass index (BMI).||0.760|0.356|0.0007
72547929|NCT03093324|144624696|SUPERIORITY||Rate ratio|0.714||||0.009|TWO_SIDED|95.0|0.554|0.921|||Negative Binomial Regression Model|||Number of event days was analyzed by a negative binomial regression model, with the logarithmic transformation of the number of exposure days as the ''offset'' parameter and treatment group as a factor and adjusting for study part, region (US and non-US), age, and body mass index (BMI).||0.921|0.554|0.009
72581596|NCT01038336|144693481|SUPERIORITY_OR_OTHER|||||||0.03|TWO_SIDED||||||ANOVA|||||||0.030
72581597|NCT01038336|144693482|SUPERIORITY_OR_OTHER|||||||0.092|TWO_SIDED||||||ANOVA|||||||0.092
72581598|NCT01038336|144693483|SUPERIORITY_OR_OTHER|||||||0.832|TWO_SIDED||||||ANOVA|||||||0.832
72581599|NCT01038336|144693484|SUPERIORITY_OR_OTHER|||||||0.454|TWO_SIDED||||||ANOVA|||||||0.454
72581600|NCT01038336|144693485|SUPERIORITY_OR_OTHER|||||||0.128|TWO_SIDED||||||ANOVA|||||||0.128
72581601|NCT02763046|144693495|SUPERIORITY||Odds Ratio (OR)|1.32||||0.3512|TWO_SIDED|95.0|0.74|2.36|||Regression, Logistic|||||2.36|0.74|0.3512
72581602|NCT02763046|144693496|SUPERIORITY||Odds Ratio (OR)|1.33||||0.401|TWO_SIDED|95.0|0.68|2.6|||Regression, Logistic|||Week 12||2.60|0.68|0.4010
72581603|NCT02763046|144693496|SUPERIORITY||Odds Ratio (OR)|1.3||||0.4382|TWO_SIDED|95.0|0.67|2.55|||Regression, Logistic|||Week 12||2.55|0.67|0.4382
72581604|NCT02763046|144693496|SUPERIORITY||Odds Ratio (OR)|1.78||||0.0934|TWO_SIDED|95.0|0.91|3.5|||Regression, Logistic|||Week 16||3.50|0.91|0.0934
72581605|NCT02763046|144693496|SUPERIORITY||Odds Ratio (OR)|1.47||||0.2619|TWO_SIDED|95.0|0.75|2.9|||Regression, Logistic|||Week 16||2.90|0.75|0.2619
72581606|NCT02763046|144693497|SUPERIORITY||LS (least square) Mean|-10.29|STANDARD_ERROR_OF_MEAN|6.25||0.0997|TWO_SIDED|95.0|-22.55|1.96|||Mixed Model for Repeated Measures (MMRM)|||||1.96|-22.55|0.0997
72547930|NCT03093324|144624697|SUPERIORITY||Rate ratio|0.555||||0.009|TWO_SIDED|95.0|0.357|0.862|||Negative Binomial Regression Model|||Number of event days was analyzed by a negative binomial regression model, with the logarithmic transformation of the number of exposure days as the ''offset'' parameter and treatment group as a factor and adjusting for study part, region (US and non-US), age, and body mass index (BMI).||0.862|0.357|0.009
72547931|NCT03093324|144624698|SUPERIORITY||Rate ratio|0.696||||0.033|TWO_SIDED|95.0|0.499|0.972|||Negative Binomial Regression Model|||Number of event days was analyzed by a negative binomial regression model, with the logarithmic transformation of the number of exposure days as the ''offset'' parameter and treatment group as a factor and adjusting for study part, region (US and non-US), age, and body mass index (BMI).||0.972|0.499|0.033
72547932|NCT03093324|144624699|SUPERIORITY||Rate ratio|0.662||||0.068|TWO_SIDED|95.0|0.425|1.031|||Negative Binomial Regression Model|||Number of event days was analyzed by a negative binomial regression model, with the logarithmic transformation of the number of exposure days as the ''offset'' parameter and treatment group as a factor and adjusting for study part, region (US and non-US), age, and body mass index (BMI).||1.031|0.425|0.068
72547933|NCT03093324|144624700|SUPERIORITY||Rate ratio|0.713||||0.215|TWO_SIDED|95.0|0.417|1.217|||Negative Binomial Regression Model|||Number of event days was analyzed by a negative binomial regression model, with the logarithmic transformation of the number of exposure days as the ''offset'' parameter and treatment group as a factor and adjusting for study part, region (US and non-US), age, and body mass index (BMI).||1.217|0.417|0.215
72547934|NCT03093324|144624701|SUPERIORITY||Least Squares Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.16||0.043|TWO_SIDED|95.0|-0.6|0.0|||ANCOVA|||Nausea: DMF is used as a referenced group in the model, adjusting for study parts, region (US and non-US), age and BMI.||-0.0|-0.6|0.043
72547935|NCT03093324|144624701|SUPERIORITY||Least Squares Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.12|<|0.001|TWO_SIDED|95.0|-0.7|-0.2|||ANCOVA|||Vomiting: DMF is used as a referenced group in the model, adjusting for study parts, region (US and non-US), age and BMI.||-0.2|-0.7|<0.001
72547936|NCT03093324|144624701|SUPERIORITY||Least Squares Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.16||0.001|TWO_SIDED|95.0|-0.9|-0.2|||ANCOVA|||Upper Abdominal Pain: DMF is used as a referenced group in the model, adjusting for study parts, region (US and non-US), age and BMI.||-0.2|-0.9|0.001
72547937|NCT03093324|144624701|SUPERIORITY||Least Squares Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.15||0.403|TWO_SIDED|95.0|-0.4|0.2|||ANCOVA|||Lower Abdominal Pain: DMF is used as a referenced group in the model, adjusting for study parts, region (US and non-US), age and BMI.||0.2|-0.4|0.403
72547938|NCT03093324|144624701|SUPERIORITY||Least Squares Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.19||0.261|TWO_SIDED|95.0|-0.6|0.2|||ANCOVA|||Diarrhea: DMF is used as a referenced group in the model, adjusting for study parts, region (US and non-US), age and BMI.||0.2|-0.6|0.261
72547939|NCT00976664|144624706|SUPERIORITY_OR_OTHER|||||||0.0007|ONE_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|Group differences in VAS for low back pain from randomization visit to 6-week visit were assessed via the Wilcoxon rank sums test.||||||.0007
72547940|NCT00976664|144624706|SUPERIORITY_OR_OTHER|||||||0.3913|ONE_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|Group differences in VAS for low back pain from randomization visit to 12-week visit were assessed via the Wilcoxon rank sums test.||||||.3913
72547941|NCT00976664|144624707|SUPERIORITY_OR_OTHER|||||||0.002|ONE_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|Group differences in ODI for low back pain from randomization visit to 6-week visit were assessed using the Wilcoxon rank sums test.||||||.002
72547942|NCT00976664|144624707|SUPERIORITY_OR_OTHER|||||||0.0336|ONE_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|Group differences in ODI for low back pain from randomization visit to 12-week visit were assessed using the Wilcoxon rank sums test.||||||.0336
72547943|NCT05431153|144624718|OTHER||Ratio of adjusted geometric means|98.83|||||TWO_SIDED|90.0|94.0|103.91|||||Values were back-transformed from the log scale. The model was a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.|||103.91|94.00|
72547944|NCT05431153|144624718|OTHER||Ratio of adjusted geometric means|98.02|||||TWO_SIDED|90.0|93.88|102.35|||||Values were back-transformed from the log scale. The model was a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.|||102.35|93.88|
72547945|NCT05431153|144624718|OTHER||Ratio of adjusted geometric means|98.51|||||TWO_SIDED|90.0|91.79|105.73|||||Values were back-transformed from the log scale. The model was a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.|||105.73|91.79|
72547946|NCT05431153|144624719|OTHER||Ratio of adjusted geometric means|96.35|||||TWO_SIDED|90.0|87.48|106.12|||||Values were back-transformed from the log scale. The model was a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.|||106.12|87.48|
72547947|NCT05431153|144624719|OTHER||Ratio of adjusted geometric means|93.47|||||TWO_SIDED|90.0|85.65|102.0|||||Values were back-transformed from the log scale. The model was a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.|||102.00|85.65|
72547948|NCT05431153|144624719|OTHER||Ratio of adjusted geometric means|98.01|||||TWO_SIDED|90.0|89.86|106.9|||||Values were back-transformed from the log scale. The model was a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.|||106.90|89.86|
72547949|NCT05431153|144624720|OTHER||Ratio of adjusted geometric means|111.52|||||TWO_SIDED|90.0|99.55|124.93|||||Values were back-transformed from the log scale. The model was a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.|||124.93|99.55|
72547950|NCT05431153|144624720|OTHER||Ratio of adjusted geometric means|98.38|||||TWO_SIDED|90.0|90.68|106.73|||||Values were back-transformed from the log scale. The model was a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.|||106.73|90.68|
72581607|NCT02763046|144693497|SUPERIORITY||LS Mean|-12.3|STANDARD_ERROR_OF_MEAN|7.23||0.0888|TWO_SIDED|95.0|-26.47|1.87|||Mixed Model for Repeated Measures (MMRM)|||||1.87|-26.47|0.0888
72581608|NCT02763046|144693497|SUPERIORITY||LS Mean|-8.29|STANDARD_ERROR_OF_MEAN|7.18||0.2484|TWO_SIDED|95.0|-22.36|5.79|||Mixed Model for Repeated Measures (MMRM)|||||5.79|-22.36|0.2484
72581609|NCT02763046|144693498|SUPERIORITY||LS Mean|-2.06||||0.7735|TWO_SIDED|95.0|-16.11|11.98|||Mixed Model for Repeated Measures (MMRM)|||delayed tapering (W12) vs early tapering (W16)||11.98|-16.11|0.7735
72581610|NCT02763046|144693499|SUPERIORITY||LS Mean|-0.39|STANDARD_ERROR_OF_MEAN|0.3||0.1926|TWO_SIDED|95.0|-0.99|0.2|||Mixed Model for Repeated Measures (MMRM)|||Week 12||0.20|-0.99|0.1926
72581611|NCT02763046|144693499|SUPERIORITY||LS Mean|-0.46|STANDARD_ERROR_OF_MEAN|0.35||0.1914|TWO_SIDED|95.0|-1.14|0.23|||Mixed Model for Repeated Measures (MMRM)|||Week 12||0.23|-1.14|0.1914
72581612|NCT02763046|144693499|SUPERIORITY||LS Mean|-0.33|STANDARD_ERROR_OF_MEAN|0.34||0.3397|TWO_SIDED|95.0|-1.01|0.35|||Mixed Model for Repeated Measures (MMRM)|||Week 12||0.35|-1.01|0.3397
72581613|NCT02763046|144693499|SUPERIORITY||LS Mean|-0.68|STANDARD_ERROR_OF_MEAN|0.33||0.0384|TWO_SIDED|95.0|-1.33|-0.04|||Mixed Model for Repeated Measures (MMRM)|||Week 16||-0.04|-1.33|0.0384
72581614|NCT02763046|144693499|SUPERIORITY||LS Mean|-0.41|STANDARD_ERROR_OF_MEAN|0.33||0.2116|TWO_SIDED|95.0|-1.05|0.23|||Mixed Model for Repeated Measures (MMRM)|||Week 16||0.23|-1.05|0.2116
72581615|NCT02763046|144693500|SUPERIORITY||LS Mean|0.63|STANDARD_ERROR_OF_MEAN|1.02||0.5384|TWO_SIDED|95.0|-1.38|2.63|||Mixed Model for Repeated Measures (MMRM)|||||2.63|-1.38|0.5384
72581616|NCT02763046|144693500|SUPERIORITY||LS Mean|-0.11|STANDARD_ERROR_OF_MEAN|1.18||0.9251|TWO_SIDED|95.0|-2.43|2.21|||Mixed Model for Repeated Measures (MMRM)|||||2.21|-2.43|0.9251
72581617|NCT02763046|144693500|SUPERIORITY||LS Mean|1.36|STANDARD_ERROR_OF_MEAN|1.16||0.2432|TWO_SIDED|95.0|-0.93|3.66|||Mixed Model for Repeated Measures (MMRM)|||||3.66|-0.93|0.2432
72581618|NCT05017246|144693536|SUPERIORITY||Mean Difference (Final Values)|-44.9||||0.0249|TWO_SIDED|95.0|-84.0|-5.8|||Two-sample t-test|Unadjusted analysis|Intrathecal - Epidural|||-5.8|-84.0|0.0249
72581619|NCT05017246|144693537|SUPERIORITY||Risk Ratio (RR)|1.04||||0.94|TWO_SIDED|95.0|0.36|3.01|||Chi-squared||Estimated probability of having the event in Intrathecal group divided by that in Epidural group|||3.01|0.36|0.94
72581620|NCT05017246|144693538|SUPERIORITY||Mean Difference (Final Values)|-0.26||||0.59|TWO_SIDED|95.0|-1.01|0.48|||Bootstrap resampling method|Bootstrap resampling method based on raw data was applied for due to highly right-skewed data (5,000 Bootstrap samples were selected).|Intrathecal - Epidural|||0.48|-1.01|0.59
72581621|NCT05017246|144693539|SUPERIORITY||Risk Ratio (RR)|0.95||||0.82|TWO_SIDED|95.0|0.61|1.48|||Chi-squared||Estimated probability of having the event in Intrathecal group divided by that in Epidural group|||1.48|0.61|0.82
72581622|NCT05017246|144693542|SUPERIORITY||Risk Ratio (RR)|1.56||||0.67|TWO_SIDED|95.0|0.27|8.95|||Fisher Exact||Estimated probability of having the event in Intrathecal group divided by that in Epidural group|||8.95|0.27|0.67
72581623|NCT05017246|144693543|SUPERIORITY||Risk Ratio (RR)|2.08||||0.61|TWO_SIDED|95.0|0.19|22.2|||Fisher Exact||Estimated probability of having the event in Intrathecal group divided by that in Epidural group|||22.2|0.19|0.61
72581624|NCT01514461|144693545|SUPERIORITY_OR_OTHER||% change from reference treatment|-28.78||||0.0538|TWO_SIDED|95.0|-55.69|14.46|||Mixed Models Analysis|Mixed Model of Repeated Measurements||||14.46|-55.69|0.0538
72581625|NCT01514461|144693545|SUPERIORITY_OR_OTHER||% change from reference treatment|-40.88||||0.0182|TWO_SIDED|95.0|-63.99|-2.94|||Mixed Models Analysis|Mixed Model of Repeated Measurements||||-2.94|-63.99|0.0182
72581626|NCT02058069|144693559|NON_INFERIORITY_OR_EQUIVALENCE|The Alternative Hypothesis: The Investigational Device (RIO) true event rate is non-inferior to 0.066 (event rate for manual TKA) with a non-inferiority margin of 0.06. The 0.066 rate is based on literature and 0.06 was determined in consultation with FDA.|Rare Adverse Event Rate|0.0|||||ONE_SIDED|95.0||0.0331|||||If the upper bound is \<0.126 then the primary composite safety endpoint is met. After the surgeon completed the procedure, at the conclusion of the participant's hospital stay, and 3 months post-operative were used in this single analysis.|||0.0331||
72581627|NCT02058069|144693561|OTHER|The analysis was performed using standard OC curves generated using Sample Size Analyzer® version 2.0 by Taylor Enterprise Inc. (Dr. Wayne A. Taylor).|Alignment Difference <4.38 Degrees|1.0|||||ONE_SIDED|95.0|0.966||||||Estimation Parameter is: proportion of participants with limb alignment difference \<4.38 degrees If the lower bound is \>0.95 then the assessment passes.||||0.966|
72581628|NCT02058069|144693562|NON_INFERIORITY|The upper bound for the one-sided 95% confidence interval will be compared with -9. If the upper bound is less than -9, then non-inferiority holds.|Mean Difference (Final Values)|-33.1|||<|0.001|ONE_SIDED|95.0||-29.6|||t-test, 2 sided||If the upper bound is less than -9, then non-inferiority holds.|Change from pre-op to 3 months||-29.6||<0.001
72581629|NCT00780338|144693571|SUPERIORITY_OR_OTHER|||||||0.58|TWO_SIDED|||||The model included three fixed effect terms: group (AGTO vs. control), time (Baseline=0 years, Mid=1 year, Post=2 years), and an interaction between group and time. We report the interaction p value here.|Linear Growth Models|||We first conducted an intent-to-treat analysis by fitting a model with two sets of random effects, one for matched coalitions and one with random intercepts and linear functions of time to account for trajectories of repeated observations within respondent. The model included three fixed effect terms: group (AGTO vs. control), time (Baseline=0 years, Mid=1 year, Post=2 years), and an interaction between group and time. We report the interaction p value here.||||.58
72412326|NCT03855189|144332677|OTHER||||||<|0.01|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||<0.01
72547951|NCT05431153|144624721|OTHER||Ratio of adjusted geometric means|111.52|||||TWO_SIDED|90.0|96.46|128.93|||||Values were back-transformed from the log scale. The model was a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.|||128.93|96.46|
72412327|NCT03855189|144332677|OTHER|||||||0.02|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||0.02
72547952|NCT05431153|144624721|OTHER||Ratio of adjusted geometric means|81.39|||||TWO_SIDED|90.0|75.06|88.26|||||Values were back-transformed from the log scale. The model was a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.|||88.26|75.06|
72547953|NCT04828161|144624727|SUPERIORITY||Least square (LS) mean difference|-0.59|STANDARD_ERROR_OF_MEAN|0.138|<|0.001|TWO_SIDED|95.0|-0.86|-0.32|||ANCOVA|||||-0.32|-0.86|<0.001
72581630|NCT00780338|144693573|SUPERIORITY_OR_OTHER|||||||0.61|TWO_SIDED|||||The model included three fixed effect terms: group (AGTO vs. control), time (Baseline=0 years, Mid=1 year, Post=2 years), and an interaction between group and time. We report the interaction p value here.|Linear Growth Models|||We first conducted an intent-to-treat analysis by fitting a model with two sets of random effects, one for matched coalitions and one with random intercepts and linear functions of time to account for trajectories of repeated observations within respondent. The model included three fixed effect terms: group (AGTO vs. control), time (Baseline=0 years, Mid=1 year, Post=2 years), and an interaction between group and time. We report the interaction p value here.||||.61
72581631|NCT00780338|144693574|SUPERIORITY_OR_OTHER|||||||0.09|TWO_SIDED|||||The model included three fixed effect terms: group (AGTO vs. control), time (Baseline=0 years, Mid=1 year, Post=2 years), and an interaction between group and time. We report the interaction p value here.|Linear Growth Models|||Mirroring the intent-to-treat analysis (but comparing AGTO users to AGTO non users instead), we fitted a model with two sets of random effects, one for matched coalitions and one with random intercepts and linear functions of time to account for trajectories of repeated observations within respondent. The model included three fixed effect terms: group (AGTO vs. control), time (Baseline=0 years, Mid=1 year, Post=2 years), and an interaction between group and time.||||.09
72581632|NCT00780338|144693575|SUPERIORITY_OR_OTHER|||||||0.01|TWO_SIDED|||||The model included three fixed effect terms: group (AGTO vs. control), time (Baseline=0 years, Mid=1 year, Post=2 years), and an interaction between group and time. We report the interaction p value here.|Linear Growth Models|||Mirroring the intent-to-treat analysis (but comparing AGTO users to AGTO non users instead), we fitted a model with two sets of random effects, one for matched coalitions and one with random intercepts and linear functions of time to account for trajectories of repeated observations within respondent. The model included three fixed effect terms: group (AGTO vs. control), time (Baseline=0 years, Mid=1 year, Post=2 years), and an interaction between group and time.||||.01
72581633|NCT00780338|144693576|SUPERIORITY_OR_OTHER|||||||0|TWO_SIDED|||||The model included three fixed effect terms: group (AGTO vs. control), time (Baseline=0 years, Mid=1 year, Post=2 years), and an interaction between group and time. We report the interaction p value here.|Linear Growth Models|||Mirroring the intent-to-treat analysis (but comparing AGTO users to AGTO non users instead), we fitted a model with two sets of random effects, one for matched coalitions and one with random intercepts and linear functions of time to account for trajectories of repeated observations within respondent. The model included three fixed effect terms: group (AGTO vs. control), time (Baseline=0 years, Mid=1 year, Post=2 years), and an interaction between group and time.||||.00
72581634|NCT00780338|144693577|SUPERIORITY_OR_OTHER|||||||0.45|TWO_SIDED|||||The model included three fixed effect terms: group (AGTO vs. control), time (Baseline=0 years, Mid=1 year, Post=2 years), and an interaction between group and time. We report the interaction p value here.|Linear Growth Models|||We first conducted an intent-to-treat analysis by fitting a model with two sets of random effects, one for matched coalitions and one with random intercepts and linear functions of time to account for trajectories of repeated observations within respondent. The model included three fixed effect terms: group (AGTO vs. control), time (Baseline=0 years, Mid=1 year, Post=2 years), and an interaction between group and time. We report the interaction p value here.||||.45
72547954|NCT04828161|144624727|SUPERIORITY||LS mean difference|-0.33|STANDARD_ERROR_OF_MEAN|0.135||0.014|TWO_SIDED|95.0|-0.6|-0.07|||ANCOVA|||||-0.07|-0.60|0.014
72547955|NCT04828161|144624727|SUPERIORITY||LS mean difference|-0.42|STANDARD_ERROR_OF_MEAN|0.135||0.002|TWO_SIDED|95.0|-0.68|-0.15|||ANCOVA|||||-0.15|-0.68|0.002
72547956|NCT01082952|144624804|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0||||The p value is calculated for the results of ASM proliferation following incubation with eosinophils isolated from patients in each group. p\< 0.05 was considered significant.|ANOVA|Proliferation data was evaluated using two-way factorial ANOVA followed by Bonferroni post hoc test.||||||<0.05
72547957|NCT00135707|144624806|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.07||||0.42|TWO_SIDED|95.0|0.91|1.25|||Chi-squared|||The primary hypothesis states that antioxidant therapy initiated prior to 16 weeks gestation in women will reduce the frequency of serious maternal and infant complications associated with pregnancy related hypertension. We estimated that with a sample size of 10,000 women, the study would have 90% power to show a 30% reduction in the rate of the primary outcome, from 4% in the placebo to 2.8% in the vitamin group, with a two-sided type I error rate of 5%.||1.25|0.91|0.42
72547958|NCT00135707|144624807|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.03||||0.79|TWO_SIDED|95.0|0.85|1.24|||Chi-squared|||||1.24|0.85|0.79
72547959|NCT00135707|144624808|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.79||||0.35|TWO_SIDED|95.0|0.47|1.31|||Chi-squared|||||1.31|0.47|0.35
72547960|NCT00135707|144624809|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.68||||0.16|TWO_SIDED|95.0|0.39|1.17|||Chi-squared|||||1.17|0.39|0.16
72547961|NCT00135707|144624810|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.63||||0.34|TWO_SIDED|95.0|0.25|1.63|||Chi-squared|||||1.63|0.25|0.34
72547962|NCT00135707|144624811|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|2.49||||0.11|TWO_SIDED|95.0|0.78|7.94|||Chi-squared|||||7.94|0.78|0.11
72547963|NCT00135707|144624812|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.81||||0.57|TWO_SIDED|95.0|0.39|1.68|||Chi-squared|||||1.68|0.39|0.57
72547964|NCT00135707|144624813|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.3||||0.18|TWO_SIDED|95.0|0.89|1.9|||Chi-squared|||||1.90|0.89|0.18
72547965|NCT00135707|144624814|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.09||||0.84|TWO_SIDED|95.0|0.48|2.46|||Chi-squared|||||2.46|0.48|0.84
72547966|NCT00135707|144624815|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.07||||0.33|TWO_SIDED|95.0|0.93|1.24|||Chi-squared|||||1.24|0.93|0.33
72581635|NCT00780338|144693578|SUPERIORITY_OR_OTHER|||||||0.65|TWO_SIDED|||||The model included three fixed effect terms: group (AGTO vs. control), time (Baseline=0 years, Mid=1 year, Post=2 years), and an interaction between group and time. We report the interaction p value here.|Linear Growth Models|||We first conducted an intent-to-treat analysis by fitting a model with two sets of random effects, one for matched coalitions and one with random intercepts and linear functions of time to account for trajectories of repeated observations within respondent. The model included three fixed effect terms: group (AGTO vs. control), time (Baseline=0 years, Mid=1 year, Post=2 years), and an interaction between group and time. We report the interaction p value here.||||.65
72581636|NCT00780338|144693579|SUPERIORITY_OR_OTHER|||||||0|TWO_SIDED|||||The model included three fixed effect terms: group (AGTO vs. control), time (Baseline=0 years, Mid=1 year, Post=2 years), and an interaction between group and time. We report the interaction p value here.|Linear Growth Models|||Mirroring the intent-to-treat analysis (but comparing AGTO users to AGTO non users instead), we fitted a model with two sets of random effects, one for matched coalitions and one with random intercepts and linear functions of time to account for trajectories of repeated observations within respondent. The model included three fixed effect terms: group (AGTO vs. control), time (Baseline=0 years, Mid=1 year, Post=2 years), and an interaction between group and time.||||.00
72581637|NCT00780338|144693580|SUPERIORITY_OR_OTHER|||||||0.61|TWO_SIDED|||||The model included three fixed effect terms: group (AGTO vs. control), time (Baseline=0 years, Mid=1 year, Post=2 years), and an interaction between group and time. We report the interaction p value here.|Linear Growth Models|||We first conducted an intent-to-treat analysis by fitting a model with two sets of random effects, one for matched coalitions and one with random intercepts and linear functions of time to account for trajectories of repeated observations within respondent. The model included three fixed effect terms: group (AGTO vs. control), time (Baseline=0 years, Mid=1 year, Post=2 years), and an interaction between group and time. We report the interaction p value here.||||.61
72581638|NCT00780338|144693581|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED|||||The model included three fixed effect terms: group (AGTO vs. control), time (Baseline=0 years, Mid=1 year, Post=2 years), and an interaction between group and time. We report the interaction p value here.|Linear Growth Models|||Mirroring the intent-to-treat analysis (but comparing AGTO users to AGTO non users instead), we fitted a model with two sets of random effects, one for matched coalitions and one with random intercepts and linear functions of time to account for trajectories of repeated observations within respondent. The model included three fixed effect terms: group (AGTO vs. control), time (Baseline=0 years, Mid=1 year, Post=2 years), and an interaction between group and time.||||.02
72581639|NCT02023983|144693583|OTHER|||||||0.765|||||||Fisher Exact|||||||0.765
72581640|NCT02023983|144693584|OTHER|||||||1|||||||Fisher Exact|||||||1
72581641|NCT03743051|144693591|SUPERIORITY|The Multiple Imputation process (N=100) was performed leading to least squares mean (LSM) and standard error (SE) estimates using the ANOVA model (including treatment group and the 3 stratification factors at randomization as categorical covariates). The estimates were pooled using Rubin rule, with corresponding p-value for difference between treatment groups. The 95% confidence interval (CI) was calculated for each treatment group and for the pooled difference between the groups.|Mean Difference (Final Values)|1.345|STANDARD_ERROR_OF_MEAN|0.32|<|0.0001|TWO_SIDED|95.0|0.718|1.971|||ANOVA|||"To declare anamorelin superior to placebo, both co-primary endpoints had to be significant.~The null hypothesis for mean change in body weight from baseline over 12 weeks (H0w) and the corresponding alternative hypothesis (H1w) were:~H0w: MWa = MW; H1w: MWa ≠ MWp~Where MWa is the mean change in body weight from baseline over 12 weeks for the anamorelin arm and MWp is the mean change in body weight from baseline over 12 weeks for the placebo arm."||1.971|0.718|<0.0001
72581642|NCT03743051|144693592|SUPERIORITY|The Multiple Imputation process (N=100) was performed leading to least squares mean (LSM) and standard error (SE) estimates using the ANOVA model (including treatment group and the 3 stratification factors at randomization as categorical covariates). The estimates were pooled using Rubin rule, with corresponding p-value for difference between treatment groups. The 95% confidence interval (CI) was calculated for each treatment group and for the pooled difference between the groups.|Mean Difference (Final Values)|0.622|STANDARD_ERROR_OF_MEAN|0.434||0.1514|TWO_SIDED|95.0|-0.228|1.472|||ANOVA|||"To declare anamorelin superior to the placebo, both co-primary endpoints had to be significant.~The null hypothesis for mean change from baseline over 12 weeks in patient 5-IASS (H0A) and the corresponding alternative (H1A) were:~H0A: MAa = MAp; H1A: MAa ≠ MAp~Where MAa is the mean change from baseline over 12 weeks in 5-IASS for the anamorelin arm and MAp is the mean change from baseline over 12 weeks in 5-IASS for the placebo arm."||1.472|-0.228|0.1514
72581643|NCT03743051|144693593|SUPERIORITY|All secondary endpoints were analyzed using the same statistical model and multiple imputation approach as for the co-primary efficacy endpoints.|Mean Difference (Final Values)|2.41|STANDARD_ERROR_OF_MEAN|0.532|<|0.0001|TWO_SIDED|95.0|1.367|3.453|||ANOVA|||||3.453|1.367|<0.0001
72581644|NCT03743051|144693594|SUPERIORITY|All secondary endpoints were analyzed using the same statistical model and multiple imputation approach as for the co-primary efficacy endpoints.|Mean Difference (Final Values)|1.336|STANDARD_ERROR_OF_MEAN|0.484||0.0057|TWO_SIDED|95.0|0.388|2.284|||ANOVA|||||2.284|0.388|0.0057
72581645|NCT03743051|144693595|SUPERIORITY|All secondary endpoints were analyzed using the same statistical model and multiple imputation approach as for the co-primary efficacy endpoints.|Mean Difference (Final Values)|1.027|STANDARD_ERROR_OF_MEAN|0.403||0.0108|TWO_SIDED|95.0|0.238|1.816|||ANOVA|||||1.816|0.238|0.0108
72581646|NCT03743051|144693596|SUPERIORITY|All secondary endpoints were analyzed using the same statistical model and multiple imputation approach as for the co-primary efficacy endpoints.|Mean Difference (Final Values)|0.535|STANDARD_ERROR_OF_MEAN|0.475||0.2605|TWO_SIDED|95.0|-0.397|1.466|||ANOVA|||||1.466|-0.397|0.2605
72581647|NCT01422200|144693597|OTHER||||||<|0.05|||||||t-test, 2 sided|||||||<.05
72581648|NCT00811733|144693600|SUPERIORITY_OR_OTHER||percentage of participants|47.0|||||TWO_SIDED|95.0|21.3|73.4|||||The estimated value represents the percentage of participants with OR.|||73.4|21.3|
72581649|NCT00811733|144693600|SUPERIORITY_OR_OTHER||percentage of participants|68.0|||||TWO_SIDED|95.0|45.1|86.1|||||The estimated value represents the percentage of participants with OR.|||86.1|45.1|
72581650|NCT00811733|144693601|SUPERIORITY_OR_OTHER||percentage of participants|33.0|||||TWO_SIDED|95.0|11.8|61.6|||||The estimated value represents the percentage of participants with OR.|||61.6|11.8|
72581651|NCT00811733|144693601|SUPERIORITY_OR_OTHER||percentage of participants|64.0|||||TWO_SIDED|95.0|40.7|82.8|||||The estimated value represents the percentage of participants with OR.|||82.8|40.7|
72581652|NCT01113892|144693633|NON_INFERIORITY|"The non-inferiority margin was 15%. The following null hypothesis (H0) and alternative hypothesis (HA) were tested, with the primary patency rate at 6 months for FUSION Bioline (PF), and the primary patency rate at 6 months for EXXCEL (PE).~H0: PF - PE \< - 0.15; HA: PF - PE \> - 0.15 An exact 1-sided test was used for the observed difference of patency rates between the FUSION Bioline (test) and EXXCEL (control) products."|Mean Difference (Net)|16.4|||<|0.0001|TWO_SIDED|95.0|2.7|29.9||The threshold for significance was p = .05|Exact 1-sided test||Difference = Patency (Fusion Bioline) - Patency (EXXCEL)|It was calculated that 200 participants randomized in a 1:1 fashion would have at least 80% power to detect a difference of 15% in the number of participants with primary patency between FUSION Bioline and EXXCEL groups at 6 months. It was assumed that the ratio of Above-Knee to Below-Knee procedures was 60:40; based on this, the primary patency rate for the combined Above-Knee and Below-Knee patients was 79%. Assumptions included a 10% withdrawal rate prior to the 6-month evaluation.||29.9|2.7|<.0001
72581653|NCT01113892|144693634|EQUIVALENCE|Fisher's Exact test was used to evaluate whether subjects with any MALE event or POD were homogeneous across the treatment arms.||||||0.033|ONE_SIDED|95.0|||||Fisher Exact|||The number and percentage of subjects with a MALE or POD event were summarized by treatment group.||||.033
72581654|NCT01113892|144693635|OTHER|||||||0.017|||||||Chi-squared|Proportion of subjects who achieved primary assisted patency for both treatment groups were compared using a Chi-Square test||||||.017
72581655|NCT01113892|144693636|OTHER|||||||0.137|||||||Chi-squared|Proportion of subjects who achieve secondary patency for both treatment groups will be compared using a Chi-Square test||||||.137
72581656|NCT01113892|144693637|OTHER||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||Difference between groups were compared with the Wilcoxon Rank Sum Test||||<.0001
72581657|NCT01113892|144693639|NON_INFERIORITY|"Repeated 6 month analyses for 12 month results.The non-inferiority margin was 15%. The following null hypothesis (H0) and alternative hypothesis (HA) were tested, with the primary patency rate for FUSION Bioline (PF), and the primary patency rate for EXXCEL (PE).~H0: PF - PE \< - 0.15; HA: PF - PE \> - 0.15 An exact 1-sided test was used for the observed difference of patency rates between the FUSION Bioline (test) and EXXCEL (control) products, with a p-value ≤ .05 indicating significance."|Mean Difference (Net)|9.5||||0.0001|TWO_SIDED|95.0|-4.8|23.0|||Exact 1-sided test|||||23.0|-4.8|.0001
72581658|NCT01113892|144693641|OTHER|||||||0.181|||||||Chi-squared|Proportion of subjects who achieve primary assisted patency for both treatment groups will be compared using a Chi-Square test||||||.181
72581659|NCT01113892|144693643|OTHER|||||||0.68|||||||Chi-squared|Proportion of subjects who achieve secondary patency for both treatment groups will be compared using a Chi Square test||||||.68
72581660|NCT02200055|144693662|SUPERIORITY_OR_OTHER|This measurement was collected for each participant. A pre-operative and post-operative bioimpedance measurement was taken.|Mean Difference (Final Values)|0.53|||<|0.01|TWO_SIDED||||||Chi-squared|||||||<0.01
72581661|NCT03442751|144693668|SUPERIORITY||Mean Difference (Net)|-1.0||||0.0004|TWO_SIDED|95.0|-1.5|-0.4|||ANCOVA|||Repeated measures mixed analysis of covariance model||-0.4|-1.5|0.0004
72581662|NCT03442751|144693669|SUPERIORITY|last observation carried forward was used to impute missing Month 12 data|Mean Difference (Net)|-1.1|||<|0.0001|TWO_SIDED|95.0|-1.6|-0.6|||ANCOVA|||repeated measures mixed analysis of covariance model||-0.6|-1.6|<0.0001
72581663|NCT01015534|144693685|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.9||||0.019|TWO_SIDED|95.0|1.3|12.9||The sample size was calculated with a two-sided test,a type-I error probability of 0.05 and a power of 0.80,Twenty- eight patients in each treatment arm were required to detect a difference in ORR of 0.29|Chi-squared|||||12.9|1.3|0.019
72581664|NCT01015534|144693686|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.688||||0.704|TWO_SIDED|95.0|0.138|3.422|||Fisher Exact|||||3.422|.138|.704
72581665|NCT01015534|144693687|SUPERIORITY_OR_OTHER|||||||0.84||95.0|||||Log Rank|||||||0.84
72581666|NCT04782076|144693692|OTHER||LS Mean Difference (Final Values)|1.43|||||TWO_SIDED|90.0|1.33|1.55|||Mixed Models Analysis|Least Squares Mean (LS Mean)||||1.55|1.33|
72581667|NCT04782076|144693693|OTHER||LS Mean Difference (Final Values)|1.38|||||TWO_SIDED|90.0|1.3|1.46|||Mixed Models Analysis|||||1.46|1.30|
72581668|NCT04910100|144693701|NON_INFERIORITY|To demonstrate noninferiority, the upper limits of the 2-sided 95% confidence interval for the difference between each comparison must be lower than 1.5 mmHg at all timepoints and lower than 1.0 mmHg for the majority of the timepoints (i.e. at least 5 of 9). This was a Phase 2 study and so the sample size was not based on a formal sample size calculation. The study was planned to provide sufficient data to power a Phase 3 study.|Timepoints with Mean IOP < 1.5 mm Hg|6.0|||||TWO_SIDED|||||||||The primary efficacy analysis was the between group comparison of the mean IOP values in the study eye at each time point at each visit (a total of 9 between-group comparisons). A hierarchical analysis was conducted to compare each of the investigational products against the comparator, timolol 0.5% as follows: (1) Timolol Suspensions 0.5% (2) Nebivolol Suspension 1% (3) Nebivolol Suspension 0.5%.||||
72581669|NCT04910100|144693701|NON_INFERIORITY|To demonstrate noninferiority, the upper limits of the 2-sided 95% confidence interval for the difference between each comparison must be lower than 1.5 mmHg at all timepoints and lower than 1.0 mmHg for the majority of the timepoints (i.e. at least 5 of 9). This was a Phase 2 study and so the sample size was not based on a formal sample size calculation. The study was planned to provide sufficient data to power a Phase 3 study.|Timepoints with Mean IOP < 1.0 mm Hg|9.0|||||TWO_SIDED|||||||||The primary efficacy analysis was the between group comparison of the mean IOP values in the study eye at each time point at each visit (a total of 9 between-group comparisons). A hierarchical analysis was conducted to compare each of the investigational products against the comparator, timolol 0.5% as follows: (1) Timolol Suspensions 0.5% (2) Nebivolol Suspension 1% (3) Nebivolol Suspension 0.5%.||||
72581670|NCT04910100|144693701|NON_INFERIORITY|To demonstrate noninferiority, the upper limits of the 2-sided 95% confidence interval for the difference between each comparison must be lower than 1.5 mmHg at all timepoints and lower than 1.0 mmHg for the majority of the timepoints (i.e. at least 5 of 9). This was a Phase 2 study and so the sample size was not based on a formal sample size calculation. The study was planned to provide sufficient data to power a Phase 3 study.|Timepoints with Mean IOP < 1.5 mm Hg|0.0|||||TWO_SIDED|||||||||The primary efficacy analysis was the between group comparison of the mean IOP values in the study eye at each time point at each visit (a total of 9 between-group comparisons). A hierarchical analysis was conducted to compare each of the investigational products against the comparator, timolol 0.5% as follows: (1) Timolol Suspensions 0.5% (2) Nebivolol Suspension 1% (3) Nebivolol Suspension 0.5%.||||
72581671|NCT04910100|144693701|NON_INFERIORITY|To demonstrate noninferiority, the upper limits of the 2-sided 95% confidence interval for the difference between each comparison must be lower than 1.5 mmHg at all timepoints and lower than 1.0 mmHg for the majority of the timepoints (i.e. at least 5 of 9). This was a Phase 2 study and so the sample size was not based on a formal sample size calculation. The study was planned to provide sufficient data to power a Phase 3 study.|Timepoints with Mean IOP < 1.0 mm Hg|0.0|||||TWO_SIDED|||||||||The primary efficacy analysis was the between group comparison of the mean IOP values in the study eye at each time point at each visit (a total of 9 between-group comparisons). A hierarchical analysis was conducted to compare each of the investigational products against the comparator, timolol 0.5% as follows: (1) Timolol Suspensions 0.5% (2) Nebivolol Suspension 1% (3) Nebivolol Suspension 0.5%.||||
72412328|NCT03855189|144332678|OTHER|||||||0.03|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||0.03
72412329|NCT03855189|144332678|OTHER||||||<|0.01|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||<0.01
72581672|NCT04910100|144693701|NON_INFERIORITY|To demonstrate noninferiority, the upper limits of the 2-sided 95% confidence interval for the difference between each comparison must be lower than 1.5 mmHg at all timepoints and lower than 1.0 mmHg for the majority of the timepoints (i.e. at least 5 of 9). This was a Phase 2 study and so the sample size was not based on a formal sample size calculation. The study was planned to provide sufficient data to power a Phase 3 study.|Timepoints with Mean IOP < 1.5 mm Hg|0.0|||||TWO_SIDED|||||||||The primary efficacy analysis was the between group comparison of the mean IOP values in the study eye at each time point at each visit (a total of 9 between-group comparisons). A hierarchical analysis was conducted to compare each of the investigational products against the comparator, timolol 0.5% as follows: (1) Timolol Suspensions 0.5% (2) Nebivolol Suspension 1% (3) Nebivolol Suspension 0.5%.||||
72581673|NCT04910100|144693701|NON_INFERIORITY|To demonstrate noninferiority, the upper limits of the 2-sided 95% confidence interval for the difference between each comparison must be lower than 1.5 mmHg at all timepoints and lower than 1.0 mmHg for the majority of the timepoints (i.e. at least 5 of 9). This was a Phase 2 study and so the sample size was not based on a formal sample size calculation. The study was planned to provide sufficient data to power a Phase 3 study.|Timepoints with Mean IOP < 1.0 mm Hg|0.0|||||TWO_SIDED|||||||||The primary efficacy analysis was the between group comparison of the mean IOP values in the study eye at each time point at each visit (a total of 9 between-group comparisons). A hierarchical analysis was conducted to compare each of the investigational products against the comparator, timolol 0.5% as follows: (1) Timolol Suspensions 0.5% (2) Nebivolol Suspension 1% (3) Nebivolol Suspension 0.5%.||||
72581674|NCT07034820|144693708|SUPERIORITY||Risk Difference (RD)|56.0|||<|0.001|TWO_SIDED|95.0|48.0|64.0||A priori statistical significance threshold for the primary endpoint was set at a two-sided alpha level of 0.05. No adjustment for multiple comparisons was applied to the primary outcome analysis, as it was the sole primary endpoint.|Chi-squared||The Risk Difference (RD) indicates the absolute difference in hemorrhoid regression rates between the Nimsai Herbal Group and the Placebo Group. Calculation: Nimsai Herbal (78%) - Placebo (22%) = 56%.|Powered for 56% difference (80% power, alpha=0.05) to detect the anticipated difference in hemorrhoid regression rates between groups. The sample size of N=300 (150 participants per arm) was calculated based on an expected regression rate of 22% in the placebo group and 78% in the Nimsai Herbal group. This ensured sufficient statistical power for the primary efficacy analysis.||64|48|<0.001
72581675|NCT02845700|144693709|SUPERIORITY|||||||0.08|||||||ANOVA|2 (time) x 2 (group) x 5 (dilution %) repeated measures ANOVA||||||.08
72581676|NCT02845700|144693710|SUPERIORITY|||||||0.39|||||||t-test, 2 sided|t(4) = -1.19, p = .39||Post-hoc estimates of observed power for the difference between group means was calculated to be .15.||||.39
72581677|NCT02845700|144693713|SUPERIORITY|||||||0.54|||||||t-test, 2 sided|t(4) = 0.66, p = .54||Post-hoc estimates of observed power for the difference between group means was calculated to be .08.||||.54
72581678|NCT01168427|144693749|OTHER|There was no formal statistical hypothesis tested. The goal was to estimate the procedure-related complications 90 days post implant using the Kaplan-Meier method.|Rate|0.034|||||ONE_SIDED|95.0||0.1292||||||||0.1292||
72581679|NCT00420420|144693786|SUPERIORITY_OR_OTHER|||||||0.283||95.0||||A longitudinal mixed model was used to compare groups, including factors for week, strata (MMSE score and concomitant AD therapy), treatment, and week-by-treatment interaction.|Mixed Models Analysis|||comparison at Week 4||||0.283
72581680|NCT00420420|144693787|SUPERIORITY_OR_OTHER|||||||0.18||95.0||||A longitudinal mixed model was used to compare groups, including factors for week, strata (MMSE score and concomitant AD therapy), treatment, and week-by-treatment interaction.|Mixed Models Analysis|||comparison at week 4||||0.180
72581681|NCT00420420|144693788|SUPERIORITY_OR_OTHER|||||||0.716||95.0||||A longitudinal mixed model was used to compare groups, including factors for week, strata (MMSE score and concomitant AD therapy), treatment, and week-by-treatment interaction.|Mixed Models Analysis|||comparison at Week 4||||0.716
72581682|NCT00273182|144693792|SUPERIORITY_OR_OTHER||Overall survival rate at 36 month|71.0|||||TWO_SIDED|95.0|68.6|73.2||No p values for the analysis.|Kaplan-Meier (product limit) estimates|Survival curves of cause-specific mortality were created based on Kaplan-Meier (product limit) estimates.|The estimate is the overall survival rate at 36 month. left-truncation methods were used in the survival analysis for previously implanted subjects.|For overall mortality, the endpoint is the proportion of subjects alive during three years post-implant. Survival curves of overall mortality and cause-specific mortality were created based on Kaplan-Meier (product limit) estimates. Confidence intervals will be calculated on a log-log scale.||73.2|68.6|
72581683|NCT00273182|144693792|SUPERIORITY_OR_OTHER||Cause specific survival rate at 36 month|85.3|||||TWO_SIDED|95.0|83.3|87.1||No p value for this analysis.|Kaplan-Meier (product limit) estimates|Cause specific survival rate at 36 month.|left-truncation methods were used in the survival analysis for previously implanted subjects.|For cause-specific mortality, the endpoint is the proportion of patients who are alive or do not die due to the progressive heart failure or sudden cardiac death causes during 3 years post-implant. Survival curves of cause-specific mortality were created based on Kaplan-Meier (product limit) estimates. Confidence intervals were calculated on a log-log scale.||87.1|83.3|
72581684|NCT00273182|144693796|SUPERIORITY_OR_OTHER||event free rate|89.8|||||TWO_SIDED|95.0|88.3|91.2||No p value for this analysis.|Kaplan-Meier (product limit) estimate|||Kaplan-Meier (product limit) estimate of the curve representing the time to first post-implant LV lead related complication were calculated to the first time point where fewer than 50 patients are still at risk. Confidence intervals will be calculated on a log-log scale.||91.2|88.3|
72581685|NCT00856492|144693797|SUPERIORITY_OR_OTHER|||||||0.019|||||||Chi-squared|||||||0.019
72581686|NCT00856492|144693798|SUPERIORITY_OR_OTHER|||||||0.64|||||||Log Rank|||||||0.64
72581687|NCT00856492|144693799|SUPERIORITY_OR_OTHER|||||||0.71|||||||Log Rank|||||||0.71
72581688|NCT00868530|144693815|SUPERIORITY_OR_OTHER_LEGACY|||||||0.12|TWO_SIDED||||||t-test, 2 sided|||||||0.120
72581689|NCT00070564|144693823|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.32||||0.022|TWO_SIDED|95.0|1.04|1.68|||Log Rank|||||1.68|1.04|0.022
72581690|NCT00070564|144693823|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.24||||0.072|TWO_SIDED|95.0|0.98|1.59|||Log Rank|||||1.59|0.98|0.072
72581691|NCT00070564|144693823|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.12||||0.38|TWO_SIDED|95.0|0.87|1.44|||Log Rank|||||1.44|0.87|0.38
72581692|NCT00070564|144693823|SUPERIORITY_OR_OTHER_LEGACY|||||||0.11|||||||Log Rank|||||||0.11
72581693|NCT00070564|144693823|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.93||||0.733|TWO_SIDED|95.0|0.61|1.41|||Log Rank|||||1.41|0.61|0.733
72581694|NCT00070564|144693824|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.44||||0.013|TWO_SIDED|95.0|1.08|1.93|||Log Rank|||||1.93|1.08|0.013
72581695|NCT00070564|144693824|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.46||||0.011|TWO_SIDED|95.0|1.09|1.95|||Log Rank|||||1.95|1.09|0.011
72581696|NCT00070564|144693824|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.24||||0.17|TWO_SIDED|95.0|0.91|1.68|||Log Rank|||||1.68|0.91|0.17
72581697|NCT00070564|144693824|SUPERIORITY_OR_OTHER_LEGACY|||||||0.04|||||||Log Rank|||||||0.040
72581698|NCT00070564|144693824|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.91||||0.724|TWO_SIDED|95.0|0.54|1.53|||Log Rank|||||1.53|0.54|0.724
72581699|NCT00070564|144693826|SUPERIORITY_OR_OTHER_LEGACY|||||||0.67|||||||Log Rank|||Overall treatment differences.||||0.67
72581700|NCT00070564|144693826|SUPERIORITY_OR_OTHER_LEGACY|||||||0.42|||||||Log Rank|||Test of interaction of two treatments: AC and paclitaxel.||||0.42
72581701|NCT00070564|144693827|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9|||||||Log Rank|||Test of overall treatment differences.||||0.90
72581702|NCT00070564|144693827|SUPERIORITY_OR_OTHER_LEGACY|||||||0.52|||||||Log Rank|||Test of interaction of two treatments: AC and paclitaxel.||||0.52
72581703|NCT00070564|144693828|SUPERIORITY_OR_OTHER_LEGACY|||||||0.076|||||||Log Rank|||Test of overall treatment differences.||||0.076
72581704|NCT00070564|144693828|SUPERIORITY_OR_OTHER_LEGACY|||||||0.018|||||||Log Rank|||Test of interaction of two treatments: AC and paclitaxel.||||0.018
72581705|NCT00070564|144693829|SUPERIORITY_OR_OTHER_LEGACY|||||||0.062|||||||Log Rank|||Test of overall treatment differences.||||0.062
72581706|NCT00070564|144693829|SUPERIORITY_OR_OTHER_LEGACY|||||||0.01|||||||Log Rank|||Test of interaction of two treatments: AC and paclitaxel.||||0.010
72581707|NCT00070564|144693830|SUPERIORITY_OR_OTHER_LEGACY|||||||0.69|||||||Log Rank|||Test of overall treatment differences.||||0.69
72581708|NCT00070564|144693830|SUPERIORITY_OR_OTHER_LEGACY|||||||0.66|||||||Log Rank|||Test of interaction two treatments: AC and paclitaxel.||||0.66
72581709|NCT00070564|144693831|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4|||||||Log Rank|||Test of overall treatment differences||||0.40
72581710|NCT00070564|144693831|SUPERIORITY_OR_OTHER_LEGACY|||||||0.28|||||||Log Rank|||Test of interaction of two treatments: AC and paclitaxel.||||0.28
72581711|NCT00931528|144693832|SUPERIORITY_OR_OTHER||Difference in percentages|5.0||||0.49|TWO_SIDED|95.0|1.0|9.0|||Chi-squared|||Sample size calculations were based on the hypothesis that the use of tadalafil would statistically significant increase the proportion of patients maintaining spontaneous erectile function compared to the use of placebo. Based on a 2-sided Fisher exact test with alpha=0.05, 91 patients/arm would provide 80% statistical power to detect an increase from 20% to 40% in spontaneous erectile response at weeks 28-30. Although designed for the Fisher exact test, Chi-square was used and reported.||9|1|0.49
72581712|NCT00931528|144693832|SUPERIORITY|||||||0.2386|||||||Regression, Logistic|||Logistic regression using generalized estimating equations was performed modeling the probability of non-responders. Only treatment arm (Placebo vs. Tadalafil), age (\> 65 vs. other), RT method (External RT vs. brachytherapy), and significant pretreatment characteristics \[N stage (NX vs. N0)\] were retained in the model. (Dropped: ethnicity, Zubrod, T stage, prostate-specific antigen (PSA).) The results for each explanatory variable are reported separately. Treatment arm is reported here.||||0.2386
72581713|NCT00931528|144693832|SUPERIORITY|||||||0.7908|||||||Regression, Linear|||Logistic regression using generalized estimating equations was performed modeling the probability of non-responders. Only treatment arm (Placebo vs. Tadalafil), age (\> 65 vs. other), RT method (External RT vs. brachytherapy), and significant pretreatment characteristics \[N stage (NX vs. N0)\] were retained in the model. (Dropped pretreatment characteristics: ethnicity, Zubrod, T stage, PSA.)The results for each explanatory variable are reported separately. RT method is reported here.||||0.7908
72581714|NCT00931528|144693832|SUPERIORITY|||||||0.0467|||||||Regression, Logistic|||Logistic regression using generalized estimating equations was performed modeling the probability of non-responders. Only treatment arm (Placebo vs. Tadalafil), age (\> 65 vs. other), RT method (External RT vs. brachytherapy), and significant pretreatment characteristics \[N stage (NX vs. N0)\] were retained in the model. (Dropped pretreatment characteristics: ethnicity, Zubrod, T stage, PSA.) The results for each explanatory variable are reported separately. Age is reported here.||||0.0467
72581715|NCT00931528|144693832|SUPERIORITY|||||||0.0068|||||||Regression, Logistic|||Logistic regression using generalized estimating equations was performed modeling the probability of non-responders. Only treatment arm (Placebo vs. Tadalafil), age (\> 65 vs. other), RT method (External RT vs. brachytherapy), and significant pretreatment characteristics \[N stage (NX vs. N0)\] were retained in the model. (Dropped pretreatment characteristics: ethnicity, Zubrod, T stage, PSA.) The results for each explanatory variable are reported separately. N Stage is reported here.||||0.0068
72581716|NCT00931528|144693833|SUPERIORITY|||||||0.93|||||||Chi-squared|2-sided significance level = 0.05||Year 1||||0.93
72412330|NCT03855189|144332678|OTHER|||||||0.34|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||0.34
72581717|NCT00931528|144693833|SUPERIORITY|||||||0.58|||||||Chi-squared|2-sided significance level = 0.05||Year 2||||0.58
72581718|NCT00931528|144693833|SUPERIORITY|||||||0.9501|||||||Regression, Logistic|||Year 1: Logistic regression using generalized estimating equations was performed modeling the probability of non-responders. Only treatment arm (Placebo vs. Tadalafil), age (\> 65 vs. other), RT method (External RT vs. brachytherapy), and significant pretreatment characteristics \[none\] were retained in the model. (Dropped pretreatment characteristics: ethnicity, Zubrod, N stage, T stage, PSA.) The results for each explanatory variable are reported separately. Treatment arm is reported here.||||0.9501
72581719|NCT00931528|144693833|SUPERIORITY|||||||0.102|||||||Regression, Logistic|||Year 1: Logistic regression using generalized estimating equations was performed modeling the probability of non-responders. Only treatment arm (Placebo vs. Tadalafil), age (\> 65 vs. other), RT method (External RT vs. brachytherapy), and significant pretreatment characteristics \[none\] were retained in the model. (Dropped pretreatment characteristics: ethnicity, Zubrod, N stage, T stage, PSA.) The results for each explanatory variable are reported separately. RT method is reported here.||||0.1020
72581720|NCT00931528|144693833|SUPERIORITY|||||||0.1855|||||||Regression, Logistic|||Year 1: Logistic regression using generalized estimating equations was performed modeling the probability of non-responders. Only treatment arm (Placebo vs. Tadalafil), age (\> 65 vs. other), RT method (External RT vs. brachytherapy), and significant pretreatment characteristics \[none\] were retained in the model. (Dropped pretreatment characteristics: ethnicity, Zubrod, N stage, T stage, PSA.) The results for each explanatory variable are reported separately. Age is reported here.||||0.1855
72581721|NCT00931528|144693833|SUPERIORITY|||||||0.5739|||||||Regression, Logistic|||Year 2: Logistic regression using generalized estimating equations was performed modeling the probability of non-responders. Only treatment arm (Placebo vs. Tadalafil), age (\> 65 vs. other), RT method (External RT vs. brachytherapy), and significant pretreatment characteristics \[N stage (NX)\] were retained in the model. (Dropped pretreatment characteristics: ethnicity, Zubrod, T stage, PSA.) The results for each explanatory variable are reported separately. Treatment arm is reported here.||||0.5739
72581722|NCT00931528|144693833|SUPERIORITY|||||||0.0422|||||||Regression, Logistic|||Year 2: Logistic regression using generalized estimating equations was performed modeling the probability of non-responders. Only treatment arm (Placebo vs. Tadalafil), age (\> 65 vs. other), RT method (External RT vs. brachytherapy), and significant pretreatment characteristics \[N stage (NX)\] were retained in the model. (Dropped pretreatment characteristics: ethnicity, Zubrod, T stage, PSA.) The results for each explanatory variable are reported separately. RT method is reported here.||||0.0422
72581723|NCT00931528|144693833|SUPERIORITY|||||||0.5237|||||||Regression, Logistic|||Year 2: Logistic regression using generalized estimating equations was performed modeling the probability of non-responders. Only treatment arm (Placebo vs. Tadalafil), age (\> 65 vs. other), RT method (External RT vs. brachytherapy), and significant pretreatment characteristics \[N stage (NX)\] were retained in the model. (Dropped pretreatment characteristics: ethnicity, Zubrod, T stage, PSA.) The results for each explanatory variable are reported separately. Age is reported here.||||0.5237
72581724|NCT00931528|144693833|SUPERIORITY|||||||0.477|||||||Regression, Logistic|||Year 2: Logistic regression using generalized estimating equations was performed modeling the probability of non-responders. Only treatment arm (Placebo vs. Tadalafil), age (\> 65 vs. other), RT method (External RT vs. brachytherapy), and significant pretreatment characteristics \[N stage (NX)\] were retained in the model. (Dropped pretreatment characteristics: ethnicity, Zubrod, T stage, PSA.) The results for each explanatory variable are reported separately. N Stage is reported here.||||0.4770
72581725|NCT00931528|144693834|SUPERIORITY|||||||0.97|||||||t-test, 2 sided|Significance level = 0.05||Week 30||||0.97
72581726|NCT00931528|144693834|SUPERIORITY|||||||0.99|||||||t-test, 2 sided|Significance level = 0.05||Year 1||||0.99
72581727|NCT00931528|144693834|SUPERIORITY|||||||0.24|||||||t-test, 2 sided|Significance level = 0.05||Year 2||||0.24
72581728|NCT00931528|144693835|SUPERIORITY|||||||0.7|||||||t-test, 2 sided|Significance level = 0.05||Week 30||||0.70
72581729|NCT00931528|144693835|SUPERIORITY|||||||0.65|||||||t-test, 2 sided|Significance level = 0.05||Year 1||||0.65
72581730|NCT00931528|144693835|SUPERIORITY|||||||0.72|||||||t-test, 2 sided|Significance level = 0.05||||||0.72
72581731|NCT00931528|144693836|SUPERIORITY|||||||0.14|||||||t-test, 2 sided|Significance level = 0.05||Week 30||||0.14
72412331|NCT03855189|144332679|OTHER||||||<|0.01|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||<0.01
72412332|NCT03855189|144332679|OTHER||||||<|0.01|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||<0.01
72412333|NCT03855189|144332679|OTHER|||||||0.04|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||0.04
72581732|NCT00931528|144693836|SUPERIORITY|||||||0.64|||||||t-test, 2 sided|Significance level = 0.05||Year 1||||0.64
72581733|NCT00931528|144693836|SUPERIORITY|||||||0.18|||||||t-test, 2 sided|Significance level = 0.05||Year 2||||0.18
72581734|NCT00931528|144693837|SUPERIORITY|||||||0.67|||||||t-test, 2 sided|Significance level = 0.05||Week 30||||0.67
72581735|NCT00931528|144693837|SUPERIORITY|||||||0.98|||||||t-test, 2 sided|Significance level = 0.05||Year 1||||0.98
72581736|NCT00931528|144693837|SUPERIORITY|||||||0.96|||||||t-test, 2 sided|Significance level = 0.05||Year 2||||0.96
72581737|NCT00931528|144693838|SUPERIORITY|||||||0.86|||||||t-test, 2 sided|Significance level = 0.05||Week 30||||0.86
72581738|NCT00931528|144693838|SUPERIORITY|||||||0.93|||||||t-test, 2 sided|Significance level = 0.05||Year 1||||0.93
72581739|NCT00931528|144693838|SUPERIORITY|||||||0.52|||||||t-test, 2 sided|Significance level = 0.05||Year 2||||0.52
72581740|NCT02493660|144693841|NON_INFERIORITY|The non-inferiority margin was 10% for all composite endpoints. The primary analysis method was a multilinear regression model for month 12 success with age (\<65 years, ≥65 years), gender, and treatment as the model covariates for the PP population for noninferiority testing.||||||0.0049|||||||Regression, Logistic|Primary analysis method was for month 12 success with age (\<65 years, ≥65 years), sex, and treatment as the model covariates.||||||0.0049
72581741|NCT02493660|144693844|NON_INFERIORITY|The non-inferiority margin was 10% for all composite endpoints.|||||<|0.05|||||||Regression, Logistic|||Results from logistic regression model.||||<0.05
72581742|NCT02502149|144693887|OTHER||Adjusted Geometric Mean Ratio|1.08|||||TWO_SIDED|90.0|0.93|1.24|||||The adjusted geometric mean ratio is calculated as 15K (PK2)/2K (PK1).|||1.24|0.93|
72581743|NCT02502149|144693888|OTHER||Adjusted Geometric Mean Ratio|1.01|||||TWO_SIDED|90.0|0.87|1.16|||||The adjusted geometric mean ratio is calculated as 15K (PK2)/2K (PK1).|||1.16|0.87|
72581744|NCT02222922|144693993|OTHER|The ratio and 90% confidence interval were expressed as percentages.|Geometric Mean Ratio (GMR)|79.38||||0.3105|TWO_SIDED|90.0|54.01|116.65|||ANOVA|||Test: PF-06647020 1.4 mg/kg + Fluconazole(Q3W-DDI) group; Reference: PF-06647020 2.8 mg/kg (Q3W-DDI) group.||116.65|54.01|0.3105
72581745|NCT02222922|144693994|OTHER|The ratio and 90% confidence interval were expressed as percentages.|Geometric Mean Ratio (GMR)|77.23||||0.2316|TWO_SIDED|90.0|53.8|110.87|||ANOVA|||Test: PF-06647020 1.4 mg/kg + Fluconazole(Q3W-DDI) group; Reference: PF-06647020 2.8 mg/kg (Q3W-DDI) group.||110.87|53.80|0.2316
72581746|NCT02222922|144693995|OTHER|The ratio and 90% confidence interval were expressed as percentages.|Geometric Mean Ratio (GMR)|84.97||||0.4264|TWO_SIDED|90.0|60.05|120.22|||ANOVA|||Test: PF-06647020 1.4 mg/kg + Fluconazole(Q3W-DDI) group; Reference: PF-06647020 2.8 mg/kg (Q3W-DDI) group.||120.22|60.05|0.4264
72581747|NCT02222922|144693996|OTHER|The ratio and 90% confidence interval were expressed as percentages.|Geometric Mean Ratio (GMR)|88.32||||0.5123|TWO_SIDED|90.0|64.03|121.82|||ANOVA|||Test: PF-06647020 1.4 mg/kg + Fluconazole(Q3W-DDI) group; Reference: PF-06647020 2.8 mg/kg (Q3W-DDI) group.||121.82|64.03|0.5123
72581748|NCT02222922|144693997|OTHER|The ratio and 90% confidence interval were expressed as percentages.|Geometric Mean Ratio (GMR)|91.15||||0.824|TWO_SIDED|90.0|44.79|185.5|||ANOVA|||Test: PF-06647020 1.4 mg/kg + Fluconazole(Q3W-DDI) group; Reference: PF-06647020 2.8 mg/kg (Q3W-DDI) group.||185.50|44.79|0.8240
72581749|NCT02222922|144693998|OTHER|The ratio and 90% confidence interval were expressed as percentages.|Geometric Mean Ratio (GMR)|89.58||||0.7922|TWO_SIDED|90.0|43.94|182.62|||ANOVA|||Test: PF-06647020 1.4 mg/kg + Fluconazole(Q3W-DDI) group; Reference: PF-06647020 2.8 mg/kg (Q3W-DDI) group.||182.62|43.94|0.7922
72581750|NCT02222922|144693999|OTHER|The ratio and 90% confidence interval were expressed as percentages.|Geometric Mean Ratio (GMR)|91.17||||0.824|TWO_SIDED|90.0|44.87|185.25|||ANOVA|||Test: PF-06647020 1.4 mg/kg + Fluconazole(Q3W-DDI) group; Reference: PF-06647020 2.8 mg/kg (Q3W-DDI) group.||185.25|44.87|0.8240
72581751|NCT02222922|144694000|OTHER|The ratio and 90% confidence interval were expressed as percentages.|Geometric Mean Ratio (GMR)|102.31||||0.9553|TWO_SIDED|90.0|51.08|204.9|||ANOVA|||Test: PF-06647020 1.4 mg/kg + Fluconazole(Q3W-DDI) group; Reference: PF-06647020 2.8 mg/kg (Q3W-DDI) group.||204.90|51.08|0.9553
72581752|NCT02222922|144694001|OTHER|The ratio and 90% confidence interval were expressed as percentages.|Geometric Mean Ratio (GMR)|81.14||||0.2951|TWO_SIDED|90.0|57.99|113.54|||ANOVA|||Test: PF-06647020 1.4 mg/kg + Fluconazole(Q3W-DDI) group; Reference: PF-06647020 2.8 mg/kg (Q3W-DDI) group.||113.54|57.99|0.2951
72581753|NCT02222922|144694002|OTHER|The ratio and 90% confidence interval were expressed as percentages.|Geometric Mean Ratio (GMR)|84.02||||0.3769|TWO_SIDED|90.0|60.24|117.19|||ANOVA|||Test: PF-06647020 1.4 mg/kg + Fluconazole(Q3W-DDI) group; Reference: PF-06647020 2.8 mg/kg (Q3W-DDI) group.||117.19|60.24|0.3769
72581754|NCT02222922|144694003|OTHER|The ratio and 90% confidence interval were expressed as percentages.|Geometric Mean Ratio (GMR)|86.15||||0.4385|TWO_SIDED|90.0|62.2|119.32|||ANOVA|||Test: PF-06647020 1.4 mg/kg + Fluconazole(Q3W-DDI) group; Reference: PF-06647020 2.8 mg/kg (Q3W-DDI) group.||119.32|62.20|0.4385
72581755|NCT02222922|144694004|OTHER|The ratio and 90% confidence interval were expressed as percentages.|Geometric Mean Ratio (GMR)|88.75||||0.5678|TWO_SIDED|90.0|62.24|126.56|||ANOVA|||Test: PF-06647020 1.4 mg/kg + Fluconazole(Q3W-DDI) group; Reference: PF-06647020 2.8 mg/kg (Q3W-DDI) group.||126.56|62.24|0.5678
72581756|NCT03290378|144694117|SUPERIORITY||||||<|0.005|TWO_SIDED|95.0|||||ANCOVA|||||||<.005
72581757|NCT03207776|144694118|SUPERIORITY||Odds Ratio (OR)|0.8||||0.041|TWO_SIDED|95.0|0.64|0.99|||Mixed Models Analysis|||||0.99|0.64|0.041
72581758|NCT03207776|144694119|SUPERIORITY||Odds Ratio (OR)|0.99||||0.952|TWO_SIDED|95.0|0.69|1.42|||Mixed Models Analysis|||||1.42|0.69|0.952
72581759|NCT03207776|144694120|SUPERIORITY||Odds Ratio (OR)|0.91||||0.472|TWO_SIDED|95.0|0.71|1.17|||Mixed Models Analysis|||||1.17|0.71|0.472
72581760|NCT03207776|144694121|SUPERIORITY||Odds Ratio (OR)|1.14||||0.544|TWO_SIDED|95.0|0.74|1.77|||Mixed Models Analysis|||||1.77|0.74|0.544
72581761|NCT00116779|144694122|SUPERIORITY_OR_OTHER||Percentage of participants|86.0||||||95.0|73.0|94.0|||||The 95% confidence interval was calculated by Clopper-Pearson method.|||94|73|
72581762|NCT00116779|144694122|SUPERIORITY_OR_OTHER||Percentage of participants|77.0||||||95.0|64.0|88.0|||||The 95% confidence interval was calculated by Clopper-Pearson method.|||88|64|
72581763|NCT00116779|144694123|SUPERIORITY_OR_OTHER||Percentage of participants|90.0||||||95.0|79.0|96.0|||||The 95% confidence interval was calculated by Clopper-Pearson method.|||96|79|
72581764|NCT00116779|144694123|SUPERIORITY_OR_OTHER||Percentage of participants|89.0||||||95.0|78.0|95.0|||||The 95% confidence interval was calculated by Clopper-Pearson method.|||95|78|
72581765|NCT00116779|144694123|SUPERIORITY_OR_OTHER|||||||0.8413||95.0|||||Chi-squared|||||||0.8413
72581766|NCT00116779|144694124|SUPERIORITY_OR_OTHER||Percentage of participants|93.0||||||95.0|82.0|99.0|||||The 95% confidence interval was calculated by Clopper-Pearson method.|||99|82|
72581767|NCT00116779|144694124|SUPERIORITY_OR_OTHER||Percentage of participants|98.0||||||95.0|87.0|100.0|||||The 95% confidence interval was calculated by Clopper-Pearson method.|||100|87|
72547967|NCT00135707|144624816|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.1||||0.004|TWO_SIDED|95.0|1.03|1.17|||Chi-squared|||||1.17|1.03|0.004
72547968|NCT00135707|144624817|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.07||||0.25|TWO_SIDED|95.0|0.95|1.21|||Chi-squared|||||1.21|0.95|0.25
72547969|NCT00135707|144624818|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.73||||0.15||95.0|0.47|1.12|||Chi-squared|||||1.12|0.47|0.15
72547970|NCT00135707|144624819|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.75||||0.51|TWO_SIDED|95.0|0.32|1.77|||Chi-squared|||||1.77|0.32|0.51
72547971|NCT00135707|144624820|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.21||||0.33|TWO_SIDED|95.0|0.82|1.79|||Chi-squared|||||1.79|0.82|0.33
72547972|NCT00135707|144624821|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.96||||0.74|TWO_SIDED|95.0|0.75|1.22|||Chi-squared|||||1.22|0.75|0.74
72547973|NCT00135707|144624822|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.66||||0.12|TWO_SIDED|95.0|0.4|1.11|||Chi-squared|||||1.11|0.40|0.12
72547974|NCT00135707|144624823|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.03||||0.35|TWO_SIDED|95.0|0.97|1.11|||Chi-squared|||||1.11|0.97|0.35
72547975|NCT00135707|144624825|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.3||||0.05|TWO_SIDED|95.0|0.08|1.08|||Chi-squared|||||1.08|0.08|0.05
72547976|NCT00135707|144624826|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.67||||0.05|TWO_SIDED|95.0|0.45|1.01|||Chi-squared|||||1.01|0.45|0.05
72547977|NCT00135707|144624827|SUPERIORITY_OR_OTHER|||||||0.65||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.65
72581768|NCT00116779|144694125|SUPERIORITY_OR_OTHER|||||||0.904||95.0|||||Log Rank|||Time to 50% reduction||||.904
72581769|NCT00116779|144694125|SUPERIORITY_OR_OTHER|||||||0.778||95.0|||||Log Rank|||Days to 90% reduction||||.778
72581770|NCT02105467|144694135|SUPERIORITY_OR_OTHER||||||<|0.001|||||||One-sided, one-sample exact test|||Superiority of SVR12 in the Immediate Treatment group was tested against the historical response rate of 73%.||||<0.001
72547978|NCT00135707|144624828|SUPERIORITY_OR_OTHER|||||||0.21||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.21
72547979|NCT00135707|144624829|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.97||||0.63|TWO_SIDED|95.0|0.87|1.09|||Chi-squared|||\<37 weeks' gestation||1.09|0.87|0.63
72547980|NCT00135707|144624829|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.86||||0.16|TWO_SIDED|95.0|0.69|1.06|||Chi-squared|||\<32 weeks' gestation||1.06|0.69|0.16
72547981|NCT00135707|144624830|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.92||||0.53|TWO_SIDED|95.0|0.72|1.19|||Chi-squared|||||1.19|0.72|0.53
72547982|NCT00135707|144624831|SUPERIORITY_OR_OTHER|||||||0.55||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.55
72547983|NCT00135707|144624832|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.0||||0.98|TWO_SIDED|95.0|0.79|1.27|||Chi-squared|||||1.27|0.79|0.98
72547984|NCT00135707|144624833|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.93||||0.32|TWO_SIDED|95.0|0.81|1.07|||Chi-squared|||||1.07|0.81|0.32
72547985|NCT00135707|144624834|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.03||||0.58|TWO_SIDED|95.0|0.92|1.15|||Chi-squared|||||1.15|0.92|0.58
72547986|NCT00135707|144624835|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.04||||0.75|TWO_SIDED|95.0|0.83|1.3|||Chi-squared|||||1.30|0.83|0.75
72547987|NCT00135707|144624836|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.85||||0.78|TWO_SIDED|95.0|0.29|2.54|||Chi-squared|||||2.54|0.29|0.78
72547988|NCT00135707|144624837|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.3||||0.34|TWO_SIDED|95.0|0.76|2.23|||Chi-squared|||||2.23|0.76|0.34
72547989|NCT00135707|144624838|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.71||||0.41|TWO_SIDED|95.0|0.32|1.6|||Chi-squared|||||1.60|0.32|0.41
72547990|NCT00135707|144624839|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.18||||0.62|TWO_SIDED|95.0|0.61|2.3|||Chi-squared|||||2.30|0.61|0.62
72547991|NCT00135707|144624840|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.85||||0.56|TWO_SIDED|95.0|0.49|1.48|||Chi-squared|||||1.48|0.49|0.56
72547992|NCT00135707|144624841|SUPERIORITY_OR_OTHER|||||||0.79||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.79
72547993|NCT00135707|144624842|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.02||||0.86|TWO_SIDED|95.0|0.82|1.26|||Chi-squared|||||1.26|0.82|0.86
72547994|NCT00135707|144624843|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.12||||0.32|TWO_SIDED|95.0|0.89|1.42|||Chi-squared|||||1.42|0.89|0.32
72547995|NCT03093454|144624844|EQUIVALENCE|Linear mixed effects models were used to investigate HADS scores (total, anxiety, and depression), sleep scores, and pain scores. Variables for time point (preoperative/Post-op Day 1/final Post-op Day) \& arm were analyzed. Adjustment for multiple pairwise comparisons used the Scheffe method. Analyses were conducted based on the intent to treat principle. P-values\<0.05 were considered statistically significant. Each time point, the mean and corresponding 95% confidence interval has been plotted.|Odds Ratio (OR)|95.0|STANDARD_DEVIATION|1.0||0.05|TWO_SIDED|95.0||||The p value is calculated and adjusted for multiple comparisons.|Fisher Exact|||Lavender group compared to control group||||0.05
72547996|NCT04540497|144624849|OTHER||Hazard Ratio (HR)|0.13|||||TWO_SIDED|95.0|0.06|0.28|||||Inebilizumab versus placebo|||0.28|0.06|
72547997|NCT04540497|144624856|OTHER||Hazard Ratio (HR)|0.12|||||TWO_SIDED|95.0|0.05|0.26|||||Inebilizumab vs placebo|||0.26|0.05|
72547998|NCT01681030|144624863|SUPERIORITY_OR_OTHER||Proportion|0.923|||||TWO_SIDED|95.0|0.64|0.998|||||CI for EVARREST Group|||0.998|0.640|
72547999|NCT01681030|144624863|SUPERIORITY_OR_OTHER||Proportion|0.333|||||TWO_SIDED|95.0|0.133|0.59|||||CI for Topical Hemostat group|||0.590|0.133|
72548000|NCT01681030|144624863|SUPERIORITY_OR_OTHER||Proportion|0.455|||||TWO_SIDED|95.0|0.167|0.766|||||CI for Standard of Care group|||0.766|0.167|
72548001|NCT01521559|144624901|SUPERIORITY_OR_OTHER||Mean Difference (Net)|26.6||||0.0003|TWO_SIDED|95.0|13.0|40.1||P-value was calculated using 2-sided Cochran-Mantel-Haenszel test adjusted by regions (Japan vs North America) and baseline Best Corrected Visual Acuity (BCVA ≤20/200 and BCVA \>20/200).|Cochran-Mantel-Haenszel||Difference was IAI group minus laser group; Difference and confidence interval were calculated using Mantel-Haenszel weighting scheme adjusted by regions (Japan vs North America) and baseline BCVA (BCVA ≤20/200 and BCVA \>20/200).|||40.1|13.0|0.0003
72581771|NCT02105467|144694136|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-1.0|||||TWO_SIDED|95.0|-10.8|9.6|||||Between-treatment difference (Immediate Treatment Group - Deferred Treatment Group) was analyzed using the Miettinen and Nurminen method.|||9.6|-10.8|
72581772|NCT02105467|144694137|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.0|||||TWO_SIDED|95.0|-4.4|2.0|||||Between-treatment difference (Immediate Treatment Group - Deferred Treatment Group) was analyzed using the Miettinen and Nurminen method.|||2.0|-4.4|
72581773|NCT01690117|144694140|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.47|STANDARD_ERROR_OF_MEAN|1.83|<|0.001|TWO_SIDED|95.0|3.82|11.12||The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|||||11.12|3.82|<0.001
72581774|NCT01690117|144694141|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.43|STANDARD_ERROR_OF_MEAN|2.21|<|0.05|TWO_SIDED|95.0|1.0|9.86||The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|||||9.86|1.00|<0.05
72581775|NCT01690117|144694142|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.99|STANDARD_ERROR_OF_MEAN|1.0|<|0.01|TWO_SIDED|95.0|1.01|4.97||The a priori threshold for statistical significance was 0.05. For the secondary outcomes inference statistics were explorative. Therefore the p-value was not adjusted for multiple comparisons.|t-test, 2 sided|||||4.97|1.01|<0.01
72581776|NCT01690117|144694143|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.7|STANDARD_ERROR_OF_MEAN|0.87||0.06|TWO_SIDED|95.0|-0.05|3.45||The a priori threshold for statistical significance was 0.05. For the secondary outcomes inference statistics were explorative. Therefore the p-value was not adjusted for multiple comparisons.|t-test, 2 sided|||||3.45|-0.05|0.06
72581777|NCT01690117|144694144|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.71|STANDARD_ERROR_OF_MEAN|1.22||0.3|TWO_SIDED|95.0|-0.65|2.07||The a priori threshold for statistical significance was 0.05. For the secondary outcomes inference statistics were explorative. Therefore the p-value was not adjusted for multiple comparisons.|t-test, 2 sided|||||2.07|-0.65|0.30
72581778|NCT01690117|144694145|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.97|STANDARD_ERROR_OF_MEAN|1.02||0.24|TWO_SIDED|95.0|-0.66|2.59||The a priori threshold for statistical significance was 0.05. For the secondary outcomes inference statistics were explorative. Therefore the p-value was not adjusted for multiple comparisons.|t-test, 2 sided|||||2.59|-0.66|0.24
72581779|NCT01690117|144694146|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.44|STANDARD_ERROR_OF_MEAN|1.04|<|0.05|TWO_SIDED|95.0|-2.5|1.62||The a priori threshold for statistical significance was 0.05. For the secondary outcomes inference statistics were explorative. Therefore the p-value was not adjusted for multiple comparisons.|t-test, 2 sided|||||1.62|-2.50|<0.05
72581780|NCT01690117|144694147|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.19|STANDARD_ERROR_OF_MEAN|8.86||0.88|TWO_SIDED|95.0|-2.63|2.25||The a priori threshold for statistical significance was 0.05. For the secondary outcomes inference statistics were explorative. Therefore the p-value was not adjusted for multiple comparisons.|t-test, 2 sided|||||2.25|-2.63|0.88
72581781|NCT01690117|144694148|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-4.93|STANDARD_ERROR_OF_MEAN|1.92|<|0.05|TWO_SIDED|95.0|-8.74|-1.11||The a priori threshold for statistical significance was 0.05. For the secondary outcomes inference statistics were explorative. Therefore the p-value was not adjusted for multiple comparisons.|t-test, 2 sided|||||-1.11|-8.74|<0.05
72581782|NCT01690117|144694149|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.49|STANDARD_ERROR_OF_MEAN|2.41|<|0.001|TWO_SIDED|95.0|-13.31|-3.66||The a priori threshold for statistical significance was 0.05. For the secondary outcomes inference statistics were explorative. Therefore the p-value was not adjusted for multiple comparisons.|t-test, 2 sided|||||-3.66|-13.31|<0.001
72581783|NCT01690117|144694150|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.91|STANDARD_ERROR_OF_MEAN|1.98||0.05|TWO_SIDED|95.0|-7.86|0.04||The a priori threshold for statistical significance was 0.05. For the secondary outcomes inference statistics were explorative. Therefore the p-value was not adjusted for multiple comparisons.|t-test, 2 sided|||||0.04|-7.86|0.05
72581784|NCT01690117|144694151|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.24|STANDARD_ERROR_OF_MEAN|2.1||0.91|TWO_SIDED|95.0|-3.96|4.45||The a priori threshold for statistical significance was 0.05. For the secondary outcomes inference statistics were explorative. Therefore the p-value was not adjusted for multiple comparisons.|t-test, 2 sided|||||4.45|-3.96|0.91
72581785|NCT01690117|144694152|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.9|STANDARD_ERROR_OF_MEAN|1.47||0.05|TWO_SIDED|95.0|-0.01|5.81||The a priori threshold for statistical significance was 0.05. For the secondary outcomes inference statistics were explorative. Therefore the p-value was not adjusted for multiple comparisons.|t-test, 2 sided|||||5.81|-0.01|0.05
72581786|NCT01690117|144694153|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.5|STANDARD_ERROR_OF_MEAN|1.91|<|0.05|TWO_SIDED|95.0|0.68|8.33||The a priori threshold for statistical significance was 0.05. For the secondary outcomes inference statistics were explorative. Therefore the p-value was not adjusted for multiple comparisons.|t-test, 2 sided|||||8.33|0.68|<0.05
72581787|NCT01690117|144694154|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.53|STANDARD_ERROR_OF_MEAN|1.95|<|0.01|TWO_SIDED|95.0|-8.4|-0.65||The a priori threshold for statistical significance was 0.05. For the secondary outcomes inference statistics were explorative. Therefore the p-value was not adjusted for multiple comparisons.|t-test, 2 sided|||||-0.65|-8.40|<0.01
72581788|NCT01690117|144694155|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.8|STANDARD_ERROR_OF_MEAN|1.52|<|0.01|TWO_SIDED|95.0|4.78|10.83||The a priori threshold for statistical significance was 0.05. For the secondary outcomes inference statistics were explorative. Therefore the p-value was not adjusted for multiple comparisons.|t-test, 2 sided|||||10.83|4.78|<0.01
72581789|NCT01037218|144694167|SUPERIORITY_OR_OTHER||Difference in LS Means|3.38|||<|0.0001|TWO_SIDED|95.0|1.7|5.07|||ANCOVA|Baseline domain score and pooled site as covariates.||540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).||5.07|1.70|<0.0001
72412334|NCT03855189|144332680|OTHER|||||||0.06|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||0.06
72581790|NCT01037218|144694167|SUPERIORITY_OR_OTHER||Difference in LS Means|5.74|||<|0.0001|TWO_SIDED|95.0|4.05|7.43|||ANCOVA|Baseline domain score and pooled site as covariates.||540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).||7.43|4.05|<0.0001
72581791|NCT01037218|144694167|SUPERIORITY_OR_OTHER||Difference in LS Means|7.53|||<|0.0001|TWO_SIDED|95.0|5.86|9.2|||ANCOVA|Baseline domain score and pooled site as covariates.||540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).||9.20|5.86|<0.0001
72581792|NCT01037218|144694168|SUPERIORITY_OR_OTHER||Difference in LS Means|20.19|||<|0.0001|TWO_SIDED|95.0|13.44|26.93|||ANCOVA|"P-values were obtained from ANCOVA model with proportion of yes responses during the baseline period and pooled site as covariates."||540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).||26.93|13.44|<0.0001
72581793|NCT01037218|144694168|SUPERIORITY_OR_OTHER||Difference in LS Means|25.06|||<|0.0001|TWO_SIDED|95.0|18.32|31.81|||ANCOVA|"P-values were obtained from ANCOVA model with proportion of yes responses during the baseline period and pooled site as covariates."||540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).||31.81|18.32|<0.0001
72581794|NCT01037218|144694168|SUPERIORITY_OR_OTHER||Difference in LS Means|32.84|||<|0.0001|TWO_SIDED|95.0|26.18|39.5|||ANCOVA|"P-values were obtained from ANCOVA model with proportion of yes responses during the baseline period and pooled site as covariates."||540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).||39.50|26.18|<0.0001
72581795|NCT01037218|144694169|SUPERIORITY_OR_OTHER||Difference in LS Means|21.72|||<|0.0001|TWO_SIDED|95.0|14.19|29.24|||ANCOVA|"P-values were obtained from ANCOVA model with proportion of yes responses during the baseline period and pooled site as covariates."||540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).||29.24|14.19|<0.0001
72581796|NCT01037218|144694169|SUPERIORITY_OR_OTHER||Difference in LS Means|26.82|||<|0.0001|TWO_SIDED|95.0|19.27|34.37|||ANCOVA|"P-values were obtained from ANCOVA model with proportion of yes responses during the baseline period and pooled site as covariates."||540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).||34.37|19.27|<0.0001
72581797|NCT01037218|144694169|SUPERIORITY_OR_OTHER||Difference in LS Means|35.41|||<|0.0001|TWO_SIDED|95.0|27.98|42.83|||ANCOVA|"P-values were obtained from ANCOVA model with proportion of yes responses during the baseline period and pooled site as covariates."||540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).||42.83|27.98|<0.0001
72581798|NCT01037218|144694170|SUPERIORITY_OR_OTHER||Difference in LS Means|1.52|||<|0.0001|TWO_SIDED|95.0|0.81|2.23|||ANCOVA|P-values are obtained from ANCOVA model with Baseline domain score and pooled site as covariates.||540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).||2.23|0.81|<0.0001
72581799|NCT01037218|144694170|SUPERIORITY_OR_OTHER||Difference in LS Means|2.29|||<|0.0001|TWO_SIDED|95.0|1.58|3.0|||ANCOVA|P-values are obtained from ANCOVA model with Baseline domain score and pooled site as covariates.||540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).||3.00|1.58|<0.0001
72581800|NCT01037218|144694170|SUPERIORITY_OR_OTHER||Difference in LS Means|2.9|||<|0.0001|TWO_SIDED|95.0|2.2|3.6|||ANCOVA|P-values are obtained from ANCOVA model with Baseline domain score and pooled site as covariates.||540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).||3.60|2.20|<0.0001
72581801|NCT01037218|144694171|SUPERIORITY_OR_OTHER||Difference in LS Means|0.59||||0.0673|TWO_SIDED|95.0|-0.04|1.22|||ANCOVA|P-values are obtained from ANCOVA model with Baseline domain score and pooled site as covariates.||540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).||1.22|-0.04|0.0673
72581802|NCT01037218|144694171|SUPERIORITY_OR_OTHER||Difference in LS Means|1.53|||<|0.0001|TWO_SIDED|95.0|0.9|2.16|||ANCOVA|P-values are obtained from ANCOVA model with Baseline domain score and pooled site as covariates.||540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).||2.16|0.90|<0.0001
72581803|NCT01037218|144694171|SUPERIORITY_OR_OTHER||Difference in LS Means|1.53|||<|0.0001|TWO_SIDED|95.0|0.91|2.15|||ANCOVA|P-values are obtained from ANCOVA model with Baseline domain score and pooled site as covariates.||540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).||2.15|0.91|<0.0001
72412335|NCT03855189|144332680|OTHER||||||<|0.01|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||<0.01
72548002|NCT01521559|144624902|SUPERIORITY_OR_OTHER||Mean Difference (Net)|10.5|||<|0.0001|TWO_SIDED|95.0|7.1|14.0|||ANCOVA|||Difference was IAI group minus laser group. P-value, Point estimate and 95% confidence interval (CI) were based on an analysis of covariance (ANCOVA) model with baseline measurement as covariate and treatment group, region, and baseline Best Corrected Visual Acuity (BCVA ≤20/200 and BCVA \>20/200) as fixed factors.||14.0|7.1|<0.0001
72548003|NCT01521559|144624903|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-148.6|||<|0.0001|TWO_SIDED|95.0|-179.8|-117.4|||ANCOVA|||Difference was IAI group minus laser group; P-value, Point estimate, and 95% CI, were based on an ANCOVA model with baseline measurement as covariate and treatment group, region, and baseline Best Corrected Visual Acuity (BCVA ≤20/200 and BCVA \>20/200) as fixed factors.||-117.4|-179.8|<0.0001
72548004|NCT01521559|144624904|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.6||||0.0833|TWO_SIDED|95.0|-0.3|5.5|||ANCOVA|||Difference was IAI group minus laser group; P-value, Point estimate, and 95% CI, were based on an ANCOVA model with baseline measurement as covariate and treatment group, region, and baseline Best Corrected Visual Acuity (BCVA ≤20/200 and BCVA \>20/200) as fixed factors.||5.5|-0.3|0.0833
72548005|NCT00520741|144624928|SUPERIORITY_OR_OTHER||Predicted exit rate at 112 days|0.3|||||TWO_SIDED|95.0|0.246|0.355|||Kaplan-Meier|Subjects who dropped out due to non-exit criteria reasons over the 10 % censoring maximum were to be counted as an exit.||The upper limit of the Confidence Interval for the estimate of the Lacosamide (LCM) 400 mg/day exit rate was compared with the lower bound of the 95 % prediction interval for the historical-control of 0.653; hereafter referred to as the historical-control exit rate. The LCM 400 mg/day dose group would be declared an effective conversion to monotherapy treatment if the upper 95 % confidence limit for the estimate of the exit rate was less than 0.653.||0.355|0.246|
72548006|NCT00520741|144624930|SUPERIORITY_OR_OTHER||predicted exit rate at 112 days|0.323|||||TWO_SIDED|95.0|0.268|0.378|||Kaplan-Meier|Subjects who dropped out due to non-exit criteria reasons over the 10 % censoring maximum were to be counted as an exit.||The upper limit of the Confidence Interval for the estimate of the Lacosamide (LCM) 400 mg/day exit rate was compared with the historical-control exit rate. The LCM 400 mg/day dose group would be declared an effective conversion to monotherapy treatment if the upper 95 % confidence limit for the estimate of the exit rate was less than 0.653.||0.378|0.268|
72548007|NCT02750761|144624948|OTHER|Bioavailability: Geometric least squares mean ratio between the Oral Group's and IV Group's dose normalized AUC from time zero to infinity.|Geometric Least Squares Mean Ratio|1.12|||||TWO_SIDED|90.0|0.93|1.35|||||The Oral Group represented the numerator in the bioavailability ratio, and the IV Group represented the denominator.|||1.35|0.93|
72548008|NCT02584140|144624991|OTHER||||||<|0.001||||||The P-Value for Week 4 was \<0.001; The P-Value for Week 12 was 0.005; The P-Value for Week 24 was 0.029; The P-Value for Week 36 was 0.008; The P-Value for Week 48 was 0.03.|Wilcoxon (Mann-Whitney)|||||||<0.001
72548009|NCT01694485|144624992|SUPERIORITY|The study was powered for formal statistical testing of the abrilumab 70 mg and 210 mg groups. To account for multiplicity of statistical testing, primary and key secondary end points for the 2 highest doses of abrilumab (70 and 210 mg) were tested at the end of the 8-week induction period under a sequential framework at a 2-sided significance level of 0.10 using the Bonferroni-based chain procedure.|Odds Ratio (OR)|3.35||||0.021|TWO_SIDED|90.0|1.41|7.95|||Regression, Logistic|Adjusted for baseline total Mayo Score and stratification factors.|An odds ratio \> 1.0 indicates a higher remission rate for the abrilumab treatment group relative to placebo.|Comparisons between treatment groups were made using remission rates estimated from a logistic regression model adjusted for baseline total Mayo Score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||7.95|1.41|0.021
72548010|NCT01694485|144624992|SUPERIORITY||Difference in Adjusted Remission Rates|9.0|||||TWO_SIDED|90.0|1.6|14.6||||||The difference in remission rates, estimated from a logistic regression model adjusted for baseline total Mayo Score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||14.6|1.6|
72548011|NCT01694485|144624992|SUPERIORITY|The study was powered for formal statistical testing of the abrilumab 70 mg and 210 mg groups. To account for multiplicity of statistical testing, primary and key secondary end points for the 2 highest doses of abrilumab (70 and 210 mg) were tested at the end of the 8-week induction period under a sequential framework at a 2-sided significance level of 0.10 using the Bonferroni-based chain procedure.|Odds Ratio (OR)|3.33||||0.03|TWO_SIDED|90.0|1.34|8.26|||Regression, Logistic|Adjusted for baseline total Mayo Score and stratification factors|An odds ratio \> 1.0 indicates a higher remission rate for the abrilumab treatment group relative to placebo.|Comparisons between treatment groups were made using remission rates from a logistic regression model adjusted for baseline total Mayo Score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||8.26|1.34|0.030
72581804|NCT01037218|144694172|SUPERIORITY_OR_OTHER||Difference in LS Means|0.36||||0.0566|TWO_SIDED|95.0|-0.01|0.73|||ANCOVA|P-values are obtained from ANCOVA model with Baseline domain score and pooled site as covariates.||540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).||0.73|-0.01|0.0566
72581805|NCT01037218|144694172|SUPERIORITY_OR_OTHER||Difference in LS Means|0.71||||0.0002|TWO_SIDED|95.0|0.34|1.08|||ANCOVA|P-values obtained from ANCOVA model with Baseline domain score and pooled site as covariates.||540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).||1.08|0.34|0.0002
72581806|NCT01037218|144694172|SUPERIORITY_OR_OTHER||Difference in LS Means|0.71||||0.0001|TWO_SIDED|95.0|0.34|1.07|||ANCOVA|P-values obtained from ANCOVA model with Baseline domain score and pooled site as covariates.||540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).||1.07|0.34|0.0001
72581807|NCT01037218|144694173|SUPERIORITY_OR_OTHER||Difference in LS Means|0.86||||0.0019|TWO_SIDED|95.0|0.32|1.4|||ANCOVA|P-values are obtained from ANCOVA model with Baseline domain score and pooled site as covariates.||540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).||1.40|0.32|0.0019
72548012|NCT01694485|144624992|SUPERIORITY||Difference in Adjusted Remission Rates|8.9|||||TWO_SIDED|90.0|0.8|14.9||||||The difference in remission rates, estimated from a logistic regression model adjusted for baseline total Mayo Score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||14.9|0.8|
72548013|NCT01694485|144624992|SUPERIORITY|Comparisons of abrilumab 21 mg with placebo were not included in the hypothesis testing procedure and were not adjusted for multiplicity.|Odds Ratio (OR)|0.64||||0.64|TWO_SIDED|90.0|0.13|3.17|||Regression, Logistic|Adjusted for baseline total Mayo Score and stratification factors|An odds ratio \> 1.0 indicates a higher remission rate for the abrilumab treatment group relative to placebo.|Comparisons between treatment groups were made using remission rates from a logistic regression model adjusted for baseline total Mayo Score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||3.17|0.13|0.64
72548014|NCT01694485|144624992|SUPERIORITY|Analysis was not part of the formal testing.|Difference in Adjusted Remission Rates|-1.6|||||TWO_SIDED|90.0|-5.2|5.5||||||The difference in remission rates estimated from a logistic regression model adjusted for baseline total Mayo Score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||5.5|-5.2|
72548015|NCT01694485|144624992|SUPERIORITY|Comparisons of abrilumab 7 mg with placebo were not included in the hypothesis testing procedure and were not adjusted for multiplicity.|Odds Ratio (OR)|0.34||||0.49|TWO_SIDED|90.0|0.03|4.33|||Regression, Logistic|Adjusted for baseline total Mayo Score and stratification factors|An odds ratio \> 1.0 indicates a higher remission rate for the abrilumab treatment group relative to placebo.|Comparisons between treatment groups were made using remission rates from a logistic regression model adjusted for baseline total Mayo Score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||4.33|0.03|0.49
72548016|NCT01694485|144624992|SUPERIORITY|Analysis was not part of the formal testing.|Difference in Adjusted Remission Rates|-2.9|||||TWO_SIDED|90.0|-5.5|5.4||||||The difference in remission rates estimated from a logistic regression model adjusted for baseline total Mayo Score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||5.4|-5.5|
72548017|NCT01694485|144624993|SUPERIORITY|If both comparisons of the primary endpoint reached statistical significance at 0.10, results from the 2 key secondary endpoints (response and mucosal healing at week 8) were to be sequentially (70 mg vs placebo then 210 mg vs placebo) tested at significance level of 0.05 independently of each other, according to the Bonferroni-based chain procedure.|Odds Ratio (OR)|2.78|||<|0.001|TWO_SIDED|90.0|1.71|4.52|||Regression, Logistic|Adjusted for baseline total Mayo Score and stratification factors.|An odds ratio \> 1.0 indicates a higher response rate for the abrilumab treatment group relative to placebo.|Comparisons between treatment groups were made using response rates estimated from a logistic regression model adjusted for baseline total Mayo Score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||4.52|1.71|<0.001
72548018|NCT01694485|144624993|SUPERIORITY||Difference in Adjusted Response Rates|23.4|||||TWO_SIDED|90.0|11.8|33.2||||||The difference in adjusted response rates, estimated from a logistic regression model adjusted for baseline total Mayo Score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||33.2|11.8|
72552701|NCT00322465|144636213|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.92|||<|0.001|TWO_SIDED|95.0|1.93|7.98||A priori threshold for statistical significance was p\<0.05.|Regression, Logistic|Odds ratio has been adjusted for other independent variables included in the model, which are found in the other Statistical Analysis sections.||The null hypothesis is that the odds ratio for visit due to sexually transmitted disease contact (reference category is no) is 1 versus the alternative that it is greater than or less than 1.||7.98|1.93|<0.001
72548019|NCT01694485|144624993|SUPERIORITY|If both comparisons of the primary endpoint reached statistical significance at 0.10, results from the 2 key secondary endpoints (response and mucosal healing at week 8) were to be sequentially (70 mg vs placebo then 210 mg vs placebo) tested at significance level of 0.05 independently of each other, according to the Bonferroni-based chain procedure.|Odds Ratio (OR)|2.57||||0.003|TWO_SIDED|90.0|1.53|4.31|||Regression, Logistic|Adjusted for baseline total Mayo Score and stratification factors|An odds ratio \> 1.0 indicates a higher response rate for the abrilumab treatment group relative to placebo.|Comparisons between treatment groups were made using response rates from a logistic regression model adjusted for baseline total Mayo Score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||4.31|1.53|0.003
72548020|NCT01694485|144624993|SUPERIORITY||Difference in Adjusted Response Rates|21.4|||||TWO_SIDED|90.0|9.0|31.8||||||The difference in adjusted response rates, estimated from a logistic regression model adjusted for baseline total Mayo Score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||31.8|9.0|
72548021|NCT01694485|144624993|SUPERIORITY|Comparisons of abrilumab 21 mg with placebo were not included in the hypothesis testing procedure and were not adjusted for multiplicity.|Odds Ratio (OR)|2.54||||0.024|TWO_SIDED|90.0|1.29|5.02|||Regression, Logistic|Adjusted for baseline total Mayo Score and stratification factors|An odds ratio \> 1.0 indicates a higher response rate for the abrilumab treatment group relative to placebo.|Comparisons between treatment groups were made using response rates from a logistic regression model adjusted for baseline total Mayo Score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||5.02|1.29|0.024
72548022|NCT01694485|144624993|SUPERIORITY|Analysis was not part of the formal testing.|Difference in Adjusted Response Rates|21.2|||||TWO_SIDED|90.0|4.9|34.1||||||The difference in adjusted response rates, estimated from a logistic regression model adjusted for baseline total Mayo Score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||34.1|4.9|
72548023|NCT01694485|144624993|SUPERIORITY|Comparisons of abrilumab 7 mg with placebo were not included in the hypothesis testing procedure and were not adjusted for multiplicity.|Odds Ratio (OR)|0.4||||0.18|TWO_SIDED|90.0|0.13|1.22|||Regression, Logistic|Adjusted for baseline total Mayo Score and stratification factors|An odds ratio \> 1.0 indicates a higher response rate for the abrilumab treatment group relative to placebo.|Comparisons between treatment groups were made using response rates from a logistic regression model adjusted for baseline total Mayo Score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||1.22|0.13|0.18
72548024|NCT01694485|144624993|SUPERIORITY|Analysis was not part of the formal testing.|Difference in Adjusted Response Rates|-13.7|||||TWO_SIDED|90.0|-24.4|2.7||||||The difference in adjusted response rates, estimated from a logistic regression model adjusted for baseline total Mayo Score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||2.7|-24.4|
72548025|NCT01694485|144624994|SUPERIORITY|If both comparisons of the primary endpoint reached statistical significance at 0.10, results from the 2 key secondary endpoints (response and mucosal healing at week 8) were to be sequentially (70 mg vs placebo then 210 mg vs placebo) tested at significance level of 0.05 independently of each other, according to the Bonferroni-based chain procedure.|Odds Ratio (OR)|2.34||||0.011|TWO_SIDED|90.0|1.35|4.07|||Regression, Logistic|Adjusted for baseline rectosigmoidoscopy score and stratification factors.|An odds ratio \> 1.0 indicates a higher healing rate for the abrilumab treatment group relative to placebo.|Comparisons between treatment groups were made using healing rates estimated from a logistic regression model adjusted for baseline rectosigmoidoscopy score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||4.07|1.35|0.011
72548026|NCT01694485|144624994|SUPERIORITY||Difference in Adjusted Healing Rates|15.3|||||TWO_SIDED|90.0|4.8|24.0||||||The difference in adjusted healing rates, estimated from a logistic regression model adjusted for baseline rectosigmoidoscopy score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||24.0|4.8|
72548027|NCT01694485|144624994|SUPERIORITY|If both comparisons of the primary endpoint reached statistical significance at 0.10, results from the 2 key secondary endpoints (response and mucosal healing at week 8) were to be sequentially (70 mg vs placebo then 210 mg vs placebo) tested at significance level of 0.05 independently of each other, according to the Bonferroni-based chain procedure.|Odds Ratio (OR)|2.1||||0.041|TWO_SIDED|90.0|1.15|3.82|||Regression, Logistic|Adjusted for baseline rectosigmoidoscopy score and stratification factors|An odds ratio \> 1.0 indicates a higher healing rate for the abrilumab treatment group relative to placebo.|Comparisons between treatment groups were made using healing rates from a logistic regression model adjusted for baseline rectosigmoidoscopy score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||3.82|1.15|0.041
72581808|NCT01037218|144694173|SUPERIORITY_OR_OTHER||Difference in LS Means|1.55|||<|0.0001|TWO_SIDED|95.0|1.01|2.09|||ANCOVA|P-values are obtained from ANCOVA model with Baseline domain score and pooled site as covariates.||540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).||2.09|1.01|<0.0001
72581809|NCT01037218|144694173|SUPERIORITY_OR_OTHER||Difference in LS Means|2.09|||<|0.0001|TWO_SIDED|95.0|1.55|2.62|||ANCOVA|P-values are obtained from ANCOVA model with Baseline domain score and pooled site as covariates.||540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).||2.62|1.55|<0.0001
72548028|NCT01694485|144624994|SUPERIORITY||Difference in Adjusted Healing Rates|13.0|||||TWO_SIDED|90.0|1.7|22.1||||||The difference in adjusted healing rates, estimated from a logistic regression model adjusted for baseline rectosigmoidoscopy score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||22.1|1.7|
72548029|NCT01694485|144624994|SUPERIORITY|Comparisons of abrilumab 21 mg with placebo were not included in the hypothesis testing procedure and were not adjusted for multiplicity.|Odds Ratio (OR)|0.8||||0.68|TWO_SIDED|90.0|0.32|1.97|||Regression, Logistic|Adjusted for baseline rectosigmoidoscopy score and stratification factors|An odds ratio \> 1.0 indicates a higher healing rate for the abrilumab treatment group relative to placebo.|Comparisons between treatment groups were made using healing rates from a logistic regression model adjusted for baseline rectosigmoidoscopy score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||1.97|0.32|0.68
72548030|NCT01694485|144624994|SUPERIORITY|Analysis was not part of the formal testing.|Difference in Adjusted Healing Rates|-3.0|||||TWO_SIDED|90.0|-11.9|9.4||||||The difference in adjusted healing rates, estimated from a logistic regression model adjusted for baseline rectosigmoidoscopy score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||9.4|-11.9|
72548031|NCT01694485|144624994|SUPERIORITY|Comparisons of abrilumab 7 mg with placebo were not included in the hypothesis testing procedure and were not adjusted for multiplicity.|Odds Ratio (OR)|0.69||||0.6|TWO_SIDED|90.0|0.21|2.22|||Regression, Logistic|Adjusted for baseline rectosigmoidoscopy score and stratification factors|An odds ratio \> 1.0 indicates a higher healing rate for the abrilumab treatment group relative to placebo.|Comparisons between treatment groups were made using healing rates from a logistic regression model adjusted for baseline rectosigmoidoscopy score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||2.22|0.21|0.60
72548032|NCT01694485|144624994|SUPERIORITY|Analysis was not part of the formal testing.|Difference in Adjusted Healing Rates|-4.6|||||TWO_SIDED|90.0|-14.9|11.3||||||The difference in adjusted healing rates, estimated from a logistic regression model adjusted for baseline rectosigmoidoscopy score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||11.3|-14.9|
72548033|NCT01694485|144624995|SUPERIORITY||Odds Ratio (OR)|2.94||||0.09|TWO_SIDED|90.0|1.03|8.36|||Regression, Logistic|Adjusted for baseline total Mayo Score and stratification factors.|An odds ratio \> 1.0 indicates a higher sustained remission rate for the abrilumab treatment group relative to placebo.|Comparisons between treatment groups were made using sustained remission rates estimated from a logistic regression model adjusted for baseline total Mayo Score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||8.36|1.03|0.090
72548034|NCT01694485|144624995|SUPERIORITY||Difference in Adjusted Remission Rates|5.8|||||TWO_SIDED|90.0|-0.6|10.4||||||The difference in adjusted sustained remission rates, estimated from a logistic regression model adjusted for baseline total Mayo Score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||10.4|-0.6|
72548035|NCT01694485|144624995|SUPERIORITY||Odds Ratio (OR)|1.32||||0.72|TWO_SIDED|90.0|0.38|4.56|||Regression, Logistic|Adjusted for baseline total Mayo Score and stratification factors|An odds ratio \> 1.0 indicates a higher sustained remission rate for the abrilumab treatment group relative to placebo.|Comparisons between treatment groups were made using sustained remission rates from a logistic regression model adjusted for baseline total Mayo Score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||4.56|0.38|0.72
72548036|NCT01694485|144624995|SUPERIORITY||Difference in Adjusted Remission Rates|1.0|||||TWO_SIDED|90.0|-4.7|4.6||||||The difference in adjusted sustained remission rates, estimated from a logistic regression model adjusted for baseline total Mayo Score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||4.6|-4.7|
72548037|NCT01694485|144624995|SUPERIORITY|Comparisons of abrilumab 21 mg with placebo were not included in the hypothesis testing procedure and were not adjusted for multiplicity.|Odds Ratio (OR)|0.83||||0.86|TWO_SIDED|90.0|0.16|4.41|||Regression, Logistic|Adjusted for baseline total Mayo Score and stratification factors|An odds ratio \> 1.0 indicates a higher sustained remission rate for the abrilumab treatment group relative to placebo.|Comparisons between treatment groups were made using sustained remission rates from a logistic regression model adjusted for baseline total Mayo Score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||4.41|0.16|0.86
72581810|NCT01037218|144694174|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Cochran-Armitage test|||540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).||||<0.0001
72581811|NCT01037218|144694174|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Chi-squared|||540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).||||<0.0001
72548038|NCT01694485|144624995|SUPERIORITY|Analysis was not part of the formal testing.|Difference in Adjusted Remission Rates|-0.5|||||TWO_SIDED|90.0|-3.9|6.2||||||The difference in adjusted sustained remission rates estimated from a logistic regression model adjusted for baseline total Mayo Score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||6.2|-3.9|
72548039|NCT01694485|144624995|SUPERIORITY|Comparisons of abrilumab 7 mg with placebo were not included in the hypothesis testing procedure and were not adjusted for multiplicity.|Odds Ratio (OR)|0.49||||0.64|TWO_SIDED|90.0|0.04|6.31|||Regression, Logistic|Adjusted for baseline total Mayo Score and stratification factors|An odds ratio \> 1.0 indicates a higher sustained remission rate for the abrilumab treatment group relative to placebo.|Comparisons between treatment groups were made using sustained remission rates from a logistic regression model adjusted for baseline total Mayo Score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||6.31|0.04|0.64
72548040|NCT01694485|144624995|SUPERIORITY|Analysis was not part of the formal testing.|Difference in Adjusted Remission Rates|-1.7|||||TWO_SIDED|90.0|-4.2|6.4||||||The difference in adjusted sustained remission rates estimated from a logistic regression model adjusted for baseline total Mayo Score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||6.4|-4.2|
72548041|NCT00662025|144625025|SUPERIORITY_OR_OTHER||Objective Response Rate (percentage)|30.2|||||TWO_SIDED|95.0|19.2|43.0||||||||43.0|19.2|
72548042|NCT00662025|144625026|SUPERIORITY_OR_OTHER||Objective Response Rate (percentage)|27.0|||||TWO_SIDED|95.0|16.6|39.7||||||||39.7|16.6|
72548043|NCT00662025|144625027|SUPERIORITY_OR_OTHER||CBR Rate (percentage)|50.8|||||TWO_SIDED|95.0|37.9|63.6||||||||63.6|37.9|
72548044|NCT00662025|144625028|SUPERIORITY_OR_OTHER||CBR Rate (percentage)|52.4|||||TWO_SIDED|95.0|39.4|65.1||||||||65.1|39.4|
72548045|NCT03179345|144625042|SUPERIORITY||Mean Difference (Net)|-0.141|STANDARD_ERROR_OF_MEAN|0.06||0.0275|TWO_SIDED|95.0|-0.266|-0.016|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within Sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|||-0.016|-0.266|0.0275
72548046|NCT03179345|144625042|SUPERIORITY||Mean Difference (Net)|0.12|STANDARD_ERROR_OF_MEAN|0.06||0.0611|TWO_SIDED|95.0|-0.006|0.245|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|||0.245|-0.006|0.0611
72548047|NCT03179345|144625043|SUPERIORITY||Mean Difference (Net)|-0.102|STANDARD_ERROR_OF_MEAN|0.06||0.1103|TWO_SIDED|95.0|-0.227|0.024|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|||0.024|-0.227|0.1103
72548048|NCT03179345|144625043|SUPERIORITY||Mean Difference (Net)|0.12|STANDARD_ERROR_OF_MEAN|0.06||0.0611|TWO_SIDED|95.0|-0.006|0.245|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|||0.245|-0.006|0.0611
72548049|NCT03179345|144625044|SUPERIORITY||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|0.01||0.9946|TWO_SIDED|95.0|-0.02|0.02|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|||0.02|-0.02|0.9946
72548050|NCT03179345|144625044|SUPERIORITY||Mean Difference (Net)|0.02|STANDARD_ERROR_OF_MEAN|0.0125||0.1673|TWO_SIDED|95.0|-0.01|0.04|||ANCOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|||0.04|-0.01|0.1673
72548051|NCT03179345|144625044|SUPERIORITY||Mean Difference (Net)|0.01|STANDARD_ERROR_OF_MEAN|0.0125||0.6208|TWO_SIDED|95.0|-0.02|0.03|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|||0.03|-0.02|0.6208
72548052|NCT03179345|144625045|SUPERIORITY||Mean Difference (Net)|-0.4|STANDARD_ERROR_OF_MEAN|2.6||0.8799|TWO_SIDED|95.0|-5.59|4.8|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|||4.80|-5.59|0.8799
72548053|NCT03179345|144625045|SUPERIORITY||Mean Difference (Net)|0.24|STANDARD_ERROR_OF_MEAN|2.61||0.9277|TWO_SIDED|95.0|-4.97|5.45|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|||5.45|-4.97|0.9277
72548054|NCT03179345|144625045|SUPERIORITY||Mean Difference (Net)|-3.73||||0.1587|TWO_SIDED|95.0|-8.94|1.49|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|||1.49|-8.94|0.1587
72548055|NCT03179345|144625046|SUPERIORITY||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|0.0125||0.7111|TWO_SIDED|95.0|-0.03|0.02|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|||0.02|-0.03|0.7111
72548056|NCT03179345|144625046|SUPERIORITY||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|0.01||0.9048|TWO_SIDED|95.0|-0.02|0.02|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|||0.02|-0.02|0.9048
72548057|NCT03179345|144625046|SUPERIORITY||Mean Difference (Net)|-0.01|STANDARD_ERROR_OF_MEAN|0.01||0.3262|TWO_SIDED|95.0|-0.03|0.01|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|||0.01|-0.03|0.3262
72548058|NCT03179345|144625047|SUPERIORITY||Mean Difference (Net)|-0.46|STANDARD_ERROR_OF_MEAN|0.86||0.595|TWO_SIDED|95.0|-2.18|1.26|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|||1.26|-2.18|0.5950
72548059|NCT03179345|144625047|SUPERIORITY||Mean Difference (Net)|0.33|STANDARD_ERROR_OF_MEAN|0.865||0.7057|TWO_SIDED|95.0|-1.4|2.06|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|||2.06|-1.40|0.7057
72548060|NCT03179345|144625047|SUPERIORITY||Mean Difference (Net)|0.37|STANDARD_ERROR_OF_MEAN|0.865||0.6741|TWO_SIDED|95.0|-1.36|2.1|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|||2.10|-1.36|0.6741
72548061|NCT03179345|144625048|SUPERIORITY||Mean Difference (Net)|-0.05|STANDARD_ERROR_OF_MEAN|0.0175||0.007|TWO_SIDED|95.0|-0.08|-0.01|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|||-0.01|-0.08|0.0070
72548062|NCT03179345|144625048|SUPERIORITY||Mean Difference (Net)|0.01|STANDARD_ERROR_OF_MEAN|0.0175||0.5183|TWO_SIDED|95.0|-0.02|0.05|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|||0.05|-0.02|0.5183
72548063|NCT03179345|144625048|SUPERIORITY||Mean Difference (Net)|-0.01|STANDARD_ERROR_OF_MEAN|0.0175||0.5084|TWO_SIDED|95.0|-0.05|0.02|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|||0.02|-0.05|0.5084
72548064|NCT03179345|144625049|SUPERIORITY||Mean Difference (Net)|0.51|STANDARD_ERROR_OF_MEAN|0.307||0.1026|TWO_SIDED|95.0|-0.104|1.124|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|||1.124|-0.104|0.1026
72581812|NCT01037218|144694174|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Chi-squared|||540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).||||<0.0001
72581813|NCT01037218|144694174|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Chi-squared|||540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).||||<0.0001
72581814|NCT01037218|144694175|SUPERIORITY_OR_OTHER||Difference in LS Means|12.65|||<|0.0001|TWO_SIDED|95.0|7.01|18.29|||ANOVA|P-values are obtained from ANOVA model with pooled site as a covariate.||540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).||18.29|7.01|<0.0001
72581815|NCT01037218|144694175|SUPERIORITY_OR_OTHER||Difference in LS Means|19.61|||<|0.0001|TWO_SIDED|95.0|13.95|25.27|||ANOVA|P-values are obtained from ANOVA model with pooled site as a covariate.||540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).||25.27|13.95|<0.0001
72548065|NCT03179345|144625049|SUPERIORITY||Mean Difference (Net)|-0.094|STANDARD_ERROR_OF_MEAN|0.309||0.7634|TWO_SIDED|95.0|-0.711|0.523|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|||0.523|-0.711|0.7634
72548066|NCT03179345|144625049|SUPERIORITY||Mean Difference (Net)|0.51|STANDARD_ERROR_OF_MEAN|0.309||0.1041|TWO_SIDED|95.0|-0.107|1.127|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|||1.127|-0.107|0.1041
72548067|NCT03179345|144625050|SUPERIORITY||Mean Difference (Net)|-0.286|STANDARD_ERROR_OF_MEAN|0.12||0.0177|TWO_SIDED|95.0|-0.521|-0.051|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|Vision||-0.051|-0.521|0.0177
72548068|NCT03179345|144625050|SUPERIORITY||Mean Difference (Net)|-0.157|STANDARD_ERROR_OF_MEAN|0.19||0.412|TWO_SIDED|95.0|-0.536|0.222|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|Energy Level||0.222|-0.536|0.4120
72548069|NCT03179345|144625050|SUPERIORITY||Mean Difference (Net)|-0.046|STANDARD_ERROR_OF_MEAN|0.16||0.7724|TWO_SIDED|95.0|-0.362|0.27|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|Memory||0.270|-0.362|0.7724
72548070|NCT03179345|144625050|SUPERIORITY||Mean Difference (Net)|-0.121|STANDARD_ERROR_OF_MEAN|0.15||0.4255|TWO_SIDED|95.0|-0.423|0.18|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|Walking Balance||0.180|-0.423|0.4255
72548071|NCT03179345|144625050|SUPERIORITY||Mean Difference (Net)|0.017|STANDARD_ERROR_OF_MEAN|0.12||0.8925|TWO_SIDED|95.0|-0.229|0.262|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|Interest in activities||0.262|-0.229|0.8925
72548072|NCT03179345|144625050|SUPERIORITY||Mean Difference (Net)|-0.212|STANDARD_ERROR_OF_MEAN|0.14||0.1293|TWO_SIDED|95.0|-0.487|0.063|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|Coordination||0.063|-0.487|0.1293
72548073|NCT03179345|144625050|SUPERIORITY||Mean Difference (Net)|-0.14|STANDARD_ERROR_OF_MEAN|0.06||0.0304|TWO_SIDED|95.0|-0.266|-0.014|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|Tremor||-0.014|-0.266|0.0304
72581816|NCT01037218|144694175|SUPERIORITY_OR_OTHER||Difference in LS Means|27.01|||<|0.0001|TWO_SIDED|95.0|21.44|32.59|||ANOVA|P-values are obtained from ANOVA model with pooled site as a covariate.||540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).||32.59|21.44|<0.0001
72581817|NCT01037218|144694176|SUPERIORITY_OR_OTHER||Difference in LS Means|0.44|||<|0.0001|TWO_SIDED|95.0|0.3|0.57|||ANCOVA|P-values are obtained from ANCOVA model with baseline PSAE score and pooled site as covariates.||540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).||0.57|0.30|<0.0001
72581818|NCT01037218|144694176|SUPERIORITY_OR_OTHER||Difference in LS Means|0.54|||<|0.0001|TWO_SIDED|95.0|0.4|0.68|||ANCOVA|P-values are obtained from ANCOVA model with baseline PSAE score and pooled site as covariates.||540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).||0.68|0.40|<0.0001
72581819|NCT01037218|144694176|SUPERIORITY_OR_OTHER||Difference in LS Means|0.83|||<|0.0001|TWO_SIDED|95.0|0.69|0.97|||ANCOVA|P-values are obtained from ANCOVA model with baseline PSAE score and pooled site as covariates.||540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).||0.97|0.69|<0.0001
72548074|NCT03179345|144625050|SUPERIORITY||Mean Difference (Net)|-0.084|STANDARD_ERROR_OF_MEAN|0.15||0.5811|TWO_SIDED|95.0|-0.384|0.217|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|Concentration||0.217|-0.384|0.5811
72548075|NCT03179345|144625050|SUPERIORITY||Mean Difference (Net)|-0.098|STANDARD_ERROR_OF_MEAN|0.06||0.1144|TWO_SIDED|95.0|-0.22|0.024|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|Speech||0.024|-0.220|0.1144
72548076|NCT03179345|144625050|SUPERIORITY||Mean Difference (Net)|-0.109|STANDARD_ERROR_OF_MEAN|0.12||0.3774|TWO_SIDED|95.0|-0.352|0.135|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|Forgetfulness||0.135|-0.352|0.3774
72548077|NCT03179345|144625050|SUPERIORITY||Mean Difference (Net)|0.057|STANDARD_ERROR_OF_MEAN|0.34||0.8658|TWO_SIDED|95.0|-0.613|0.727|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|Sleepiness||0.727|-0.613|0.8658
72548078|NCT03179345|144625050|SUPERIORITY||Mean Difference (Net)|0.018|STANDARD_ERROR_OF_MEAN|0.1||0.8543|TWO_SIDED|95.0|-0.179|0.216|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|Moodiness||0.216|-0.179|0.8543
72548079|NCT03179345|144625050|SUPERIORITY||Mean Difference (Net)|-0.153|STANDARD_ERROR_OF_MEAN|0.19||0.4294|TWO_SIDED|95.0|-0.537|0.231|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|Alertness||0.231|-0.537|0.4294
72548080|NCT03179345|144625050|SUPERIORITY||Mean Difference (Net)|-0.113|STANDARD_ERROR_OF_MEAN|0.12||0.3613|TWO_SIDED|95.0|-0.357|0.132|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|Attention Span||0.132|-0.357|0.3613
72548081|NCT03179345|144625050|SUPERIORITY||Mean Difference (Net)|-0.047|STANDARD_ERROR_OF_MEAN|0.13||0.7201|TWO_SIDED|95.0|-0.305|0.212|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|Motivation||0.212|-0.305|0.7201
72548082|NCT03179345|144625050|SUPERIORITY||Mean Difference (Net)|-0.213|STANDARD_ERROR_OF_MEAN|0.12||0.0767|TWO_SIDED|95.0|-0.448|0.023|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|Vision||0.023|-0.448|0.0767
72548083|NCT03179345|144625050|SUPERIORITY||Mean Difference (Net)|-0.216|STANDARD_ERROR_OF_MEAN|0.19||0.2618|TWO_SIDED|95.0|-0.597|0.165|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|Energy Level||0.165|-0.597|0.2618
72548084|NCT03179345|144625050|SUPERIORITY||Mean Difference (Net)|-0.048|STANDARD_ERROR_OF_MEAN|0.16||0.7633|TWO_SIDED|95.0|-0.366|0.269|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|Memory||0.269|-0.366|0.7633
72548085|NCT03179345|144625050|SUPERIORITY||Mean Difference (Net)|-0.198|STANDARD_ERROR_OF_MEAN|0.15||0.1968|TWO_SIDED|95.0|-0.502|0.105|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|Walking Balance||0.105|-0.502|0.1968
72548086|NCT03179345|144625050|SUPERIORITY||Mean Difference (Net)|-0.05|STANDARD_ERROR_OF_MEAN|0.12||0.6891|TWO_SIDED|95.0|-0.296|0.197|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|Interest in Activities||0.197|-0.296|0.6891
72548087|NCT03179345|144625050|SUPERIORITY||Mean Difference (Net)|-0.171|STANDARD_ERROR_OF_MEAN|0.14||0.2229|TWO_SIDED|95.0|-0.447|0.106|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|Coordination||0.106|-0.447|0.2229
72548088|NCT03179345|144625050|SUPERIORITY||Mean Difference (Net)|-0.072|STANDARD_ERROR_OF_MEAN|0.06||0.2591|TWO_SIDED|95.0|-0.197|0.054|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|Tremor||0.054|-0.197|0.2591
72548089|NCT03179345|144625050|SUPERIORITY||Mean Difference (Net)|-0.057|STANDARD_ERROR_OF_MEAN|0.15||0.7099|TWO_SIDED|95.0|-0.359|0.246|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|Concentration||0.246|-0.359|0.7099
72548090|NCT03179345|144625050|SUPERIORITY||Mean Difference (Net)|-0.031|STANDARD_ERROR_OF_MEAN|0.06||0.6215|TWO_SIDED|95.0|-0.154|0.092|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|Speech||0.092|-0.154|0.6215
72412336|NCT03855189|144332680|OTHER|||||||0.03|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||0.03
72548091|NCT03179345|144625050|SUPERIORITY||Mean Difference (Net)|-0.057|STANDARD_ERROR_OF_MEAN|0.12||0.6422|TWO_SIDED|95.0|-0.302|0.187|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|Forgetfulness||0.187|-0.302|0.6422
72548092|NCT03179345|144625050|SUPERIORITY||Mean Difference (Net)|-0.483|STANDARD_ERROR_OF_MEAN|0.34||0.1574|TWO_SIDED|95.0|-1.157|0.19|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|Sleepiness||0.190|-1.157|0.1574
72548093|NCT03179345|144625050|SUPERIORITY||Mean Difference (Net)|0.084|STANDARD_ERROR_OF_MEAN|0.1||0.4039|TWO_SIDED|95.0|-0.115|0.282|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|Moodiness||0.282|-0.115|0.4039
72581820|NCT01037218|144694177|SUPERIORITY_OR_OTHER||Difference in LS Means|15.18|||<|0.0001|TWO_SIDED|95.0|10.21|20.14|||ANCOVA|"P-values are obtained from ANCOVA model with proportion of yes responses during the baseline period and pooled site as covariates."||540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).||20.14|10.21|<0.0001
72581821|NCT01037218|144694177|SUPERIORITY_OR_OTHER||Difference in LS Means|14.94|||<|0.0001|TWO_SIDED|95.0|9.96|19.92|||ANCOVA|"P-values are obtained from ANCOVA model with proportion of yes responses during the baseline period and pooled site as covariates."||540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).||19.92|9.96|<0.0001
72581822|NCT01037218|144694177|SUPERIORITY_OR_OTHER||Difference in LS Means|21.06|||<|0.0001|TWO_SIDED|95.0|16.15|25.96|||ANCOVA|"P-values are obtained from ANCOVA model with proportion of yes responses during the baseline period and pooled site as covariates."||540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).||25.96|16.15|<0.0001
72581823|NCT01037218|144694178|SUPERIORITY_OR_OTHER||Difference in LS Means|17.51|||<|0.0001|TWO_SIDED|95.0|10.22|24.81|||ANCOVA|"P-values are obtained from ANCOVA model with proportion of yes responses during the baseline period and pooled site as covariates."||540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).||24.81|10.22|<0.0001
72581824|NCT01037218|144694178|SUPERIORITY_OR_OTHER||Difference in LS Means|28.32|||<|0.0001|TWO_SIDED|95.0|21.01|35.62|||ANCOVA|"P-values are obtained from ANCOVA model with proportion of yes responses during the baseline period and pooled site as covariates."||540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).||35.62|21.01|<0.0001
72412337|NCT03855189|144332681|OTHER|||||||0.13|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||0.13
72548094|NCT03179345|144625050|SUPERIORITY||Mean Difference (Net)|-0.309|STANDARD_ERROR_OF_MEAN|0.19||0.1145|TWO_SIDED|95.0|-0.695|0.076|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|Alertness||0.076|-0.695|0.1145
72548095|NCT03179345|144625050|SUPERIORITY||Mean Difference (Net)|-0.127|STANDARD_ERROR_OF_MEAN|0.12||0.3083|TWO_SIDED|95.0|-0.372|0.119|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|Attention Span||0.119|-0.372|0.3083
72548096|NCT03179345|144625050|SUPERIORITY||Mean Difference (Net)|-0.183|STANDARD_ERROR_OF_MEAN|0.13||0.1638|TWO_SIDED|95.0|-0.443|0.0776|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|Motivation||0.0776|-0.443|0.1638
72548097|NCT03179345|144625050|SUPERIORITY||Mean Difference (Net)|-0.078|STANDARD_ERROR_OF_MEAN|0.12||0.5101|TWO_SIDED|95.0|-0.314|0.157|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|Vision||0.157|-0.314|0.5101
72548098|NCT03179345|144625050|SUPERIORITY||Mean Difference (Net)|-0.233|STANDARD_ERROR_OF_MEAN|0.19||0.2285|TWO_SIDED|95.0|-0.614|0.149|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|Energy Level||0.149|-0.614|0.2285
72548099|NCT03179345|144625050|SUPERIORITY||Mean Difference (Net)|0.118|STANDARD_ERROR_OF_MEAN|0.16||0.4612|TWO_SIDED|95.0|-0.2|0.436|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|Memory||0.436|-0.200|0.4612
72548100|NCT03179345|144625050|SUPERIORITY||Mean Difference (Net)|0.099|STANDARD_ERROR_OF_MEAN|0.15||0.519|TWO_SIDED|95.0|-0.205|0.402|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|Walking Balance||0.402|-0.205|0.5190
72548101|NCT03179345|144625050|SUPERIORITY||Mean Difference (Net)|-0.024|STANDARD_ERROR_OF_MEAN|0.12||0.8479|TWO_SIDED|95.0|-0.271|0.223|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|Interest in Activities||0.223|-0.271|0.8479
72548102|NCT03179345|144625050|SUPERIORITY||Mean Difference (Net)|-0.039|STANDARD_ERROR_OF_MEAN|0.14||0.7808|TWO_SIDED|95.0|-0.316|0.238|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|Coordination||0.238|-0.316|0.7808
72548103|NCT03179345|144625050|SUPERIORITY||Mean Difference (Net)|-0.171|STANDARD_ERROR_OF_MEAN|0.06||0.0083|TWO_SIDED|95.0|-0.296|-0.045|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|Tremor||-0.045|-0.296|0.0083
72548104|NCT03179345|144625050|SUPERIORITY||Mean Difference (Net)|-0.101|STANDARD_ERROR_OF_MEAN|0.15||0.5068|TWO_SIDED|95.0|-0.404|0.201|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|Concentration||0.201|-0.404|0.5068
72548105|NCT03179345|144625050|SUPERIORITY||Mean Difference (Net)|-0.068|STANDARD_ERROR_OF_MEAN|0.06||0.2725|TWO_SIDED|95.0|-0.191|0.055|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|Speech||0.055|-0.191|0.2725
72548106|NCT03179345|144625050|SUPERIORITY||Mean Difference (Net)|0.039|STANDARD_ERROR_OF_MEAN|0.12||0.7498|TWO_SIDED|95.0|-0.206|0.284|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|Forgetfulness||0.284|-0.206|0.7498
72548107|NCT03179345|144625050|SUPERIORITY||Mean Difference (Net)|0.152|STANDARD_ERROR_OF_MEAN|0.34||0.6554|TWO_SIDED|95.0|-0.522|0.826|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|Sleepiness||0.826|-0.522|0.6554
72581825|NCT01037218|144694178|SUPERIORITY_OR_OTHER||Difference in LS Means|33.82|||<|0.0001|TWO_SIDED|95.0|26.61|41.02|||ANCOVA|"P-values are obtained from ANCOVA model with proportion of yes responses during the baseline period and pooled site as covariates."||540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).||41.02|26.61|<0.0001
72581826|NCT01037218|144694179|SUPERIORITY_OR_OTHER||Difference in LS Means|18.73|||<|0.0001|TWO_SIDED|95.0|11.23|26.23|||ANCOVA|"P-values are obtained from ANCOVA model with proportion of yes responses during the baseline period and pooled site as covariates."||540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).||26.23|11.23|<0.0001
72581827|NCT01037218|144694179|SUPERIORITY_OR_OTHER||Difference in LS Means|29.39|||<|0.0001|TWO_SIDED|95.0|21.86|36.92|||ANCOVA|"P-values are obtained from ANCOVA model with proportion of yes responses during the baseline period and pooled site as covariates."||540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).||36.92|21.86|<0.0001
72581828|NCT01037218|144694179|SUPERIORITY_OR_OTHER||Difference in LS Means|34.35|||<|0.0001|TWO_SIDED|95.0|26.94|41.75|||ANCOVA|"P-values are obtained from ANCOVA model with proportion of yes responses during the baseline period and pooled site as covariates."||540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001(NCT00282607).||41.75|26.94|<0.0001
72581829|NCT02676882|144694180|OTHER|A Chi Squared analysis was performed to determine how the rate of relapse in Group 1 (27.3%) compared to that of historical controls in the literature (67.7%). (Cohen, JAMA 2006)||||||0.005||||||A priori threshold for statistical significance: p\<0.05|Chi-squared|||||||0.005
72412338|NCT03855189|144332681|OTHER||||||<|0.01|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||<0.01
72412339|NCT03855189|144332681|OTHER|||||||0.07|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||0.07
72548108|NCT03179345|144625050|SUPERIORITY||Mean Difference (Net)|0.082|STANDARD_ERROR_OF_MEAN|0.1||0.4143|TWO_SIDED|95.0|-0.116|0.28|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|Moodiness||0.280|-0.116|0.4143
72548109|NCT03179345|144625050|SUPERIORITY||Mean Difference (Net)|-0.055|STANDARD_ERROR_OF_MEAN|0.19||0.7761|TWO_SIDED|95.0|-0.441|0.33|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|Alertness||0.330|-0.441|0.7761
72581830|NCT02676882|144694181|OTHER|A one-way repeated measures ANOVA was used to examine the overall course of Group 2 participants' MADRS scores. (F(6, 29)=5.16, p=0.001).||||||0.001||||||a priori threshold for statistical significance: p \<0.05|ANOVA|||||||0.001
72581831|NCT02568072|144694184|SUPERIORITY|||||||0.44|||||||t-test, 2 sided|||||||0.44
72581832|NCT02568072|144694185|SUPERIORITY|||||||0.71|||||||t-test, 2 sided|||||||0.71
72581833|NCT02568072|144694186|SUPERIORITY|||||||0.37|||||||t-test, 2 sided|||||||0.37
72581834|NCT01288807|144694189|OTHER|repeated measure ANOVA|||||<|0.01|||||||ANOVA|||||||< 0.01
72581835|NCT01288807|144694190|OTHER|two-tailed paired t-test|||||<|0.05|||||||t-test, 2 sided|||This analysis looks at the cold threshold measured in degrees celcius before and after treatment.||||< 0.05
72581836|NCT01288807|144694191|OTHER||||||>|0.05|||||||t-test, 2 sided|||This analysis looks at the pressure threshold measured in pounds per square inch before and after treatment||||> 0.05
72581837|NCT01288807|144694192|OTHER||||||>|0.05||||||one-way repeated measure ANOVA|ANOVA|||||||> 0.05
72581838|NCT00707239|144694233|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-5.4|||||TWO_SIDED|70.0|-21.6|10.9||||||Cure: Confidence interval (CI) was calculated using the Wilson score method, with continuity correction. Clinical response (rates of cure) by using a 2-sided 70 percent (%) CI for the true difference in efficacy (tigecycline regimen minus imipenem/cilastatin regimen) was calculated. Statistical testing was done at 15% alpha.||10.9|-21.6|
72581839|NCT00707239|144694233|SUPERIORITY_OR_OTHER||Risk Difference (RD)|10.0|||||TWO_SIDED|70.0|-6.1|24.8||||||Cure: CI was calculated using the Wilson score method, with continuity correction. Clinical response (rates of cure) by using a 2-sided 70% CI for the true difference in efficacy (tigecycline regimen minus imipenem/cilastatin regimen) was calculated. Statistical testing was done at 15% alpha.||24.8|-6.1|
72581840|NCT00707239|144694234|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.2|||||TWO_SIDED|70.0|-14.3|14.0||||||Cure: CI was calculated using the Wilson score method, with continuity correction. Clinical response (rates of cure) by using a 2-sided 70% CI for the true difference in efficacy (tigecycline regimen minus imipenem/cilastatin regimen) was calculated. Statistical testing was done at 15% alpha.||14.0|-14.3|
72581841|NCT00707239|144694234|SUPERIORITY_OR_OTHER||Risk Difference (RD)|18.5|||||TWO_SIDED|70.0|4.3|31.8||||||Cure: CI was calculated using the Wilson score method, with continuity correction. Clinical response (rates of cure) by using a 2-sided 70% CI for the true difference in efficacy (tigecycline regimen minus imipenem/cilastatin regimen) was calculated. Statistical testing was done at 15% alpha.||31.8|4.3|
72581842|NCT00707239|144694237|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-18.5|||||TWO_SIDED|70.0|-39.6|4.2||||||Eradication: CI was calculated using the Wilson score method, with continuity correction. Microbiological response (rates of eradication) by using a 2-sided 70% CI for the true difference in efficacy (tigecycline regimen minus imipenem/cilastatin regimen) was calculated. Statistical testing was done at 15% alpha.||4.2|-39.6|
72581843|NCT00707239|144694237|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.0|||||TWO_SIDED|70.0|-23.8|20.9||||||Eradication: CI was calculated using the Wilson score method, with continuity correction. Microbiological response (rates of eradication) by using a 2-sided 70% CI for the true difference in efficacy (tigecycline regimen minus imipenem/cilastatin regimen) was calculated. Statistical testing was done at 15% alpha.||20.9|-23.8|
72412340|NCT03855189|144332682|OTHER|||||||0.03|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||0.03
72581844|NCT00707239|144694238|SUPERIORITY_OR_OTHER|||||||0.527|TWO_SIDED|||||Statistical testing was done at 5% alpha.|Fisher Exact|||Nausea: p-value was calculated using 2-tail Fischer's exact test.||||0.527
72581845|NCT00707239|144694238|SUPERIORITY_OR_OTHER|||||||0.39|TWO_SIDED|||||Statistical testing was done at 5% alpha.|Fisher Exact|||Vomiting: p-value was calculated using 2-tail Fischer's exact test.||||0.390
72581846|NCT00707239|144694239|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED|||||Statistical testing was done at 5% alpha.|Fisher Exact|||p-value was calculated using 2-tail Fischer's exact test.||||1.000
72581847|NCT00707239|144694240|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED|||||Statistical testing was done at 5% alpha.|Fisher Exact|||p-value was calculated using 2-tail Fischer's exact test.||||1.000
72581848|NCT00707239|144694246|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.0479||||0.78|TWO_SIDED|95.0|0.754|1.46|||Regression, Logistic|||Statistical analysis was carried out between categories, experienced nausea and did not experience nausea.||1.46|0.754|0.78
72581849|NCT00707239|144694246|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.84644||||0.356|TWO_SIDED|95.0|0.593|1.21|||Regression, Logistic|||Statistical analysis was carried out between categories, experienced vomiting and did not experience vomiting.||1.21|0.593|0.356
72581850|NCT00707239|144694247|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.0054||||0.836|TWO_SIDED|95.0|0.956|1.06|||Regression, Logistic|||Statistical analysis was carried out between categories, cure and failure/indeterminate.||1.06|0.956|0.836
72581851|NCT00707239|144694251|SUPERIORITY_OR_OTHER|||||||0.245|TWO_SIDED|||||Statistical testing was done at 5% alpha.|ANOVA|||Intravenous antibiotic treatment: One-way analysis of variance (ANOVA) with treatment as factor was used to calculate p-value.||||0.245
72581852|NCT00707239|144694251|SUPERIORITY_OR_OTHER|||||||0.484|TWO_SIDED|||||Statistical testing was done at 5% alpha.|ANOVA|||Hospital stay: One-way ANOVA with treatment as factor was used to calculate p-value.||||0.484
72581853|NCT00707239|144694251|SUPERIORITY_OR_OTHER|||||||0.192|TWO_SIDED|||||Statistical testing was done at 5% alpha.|ANOVA|||ICU stay: One-way ANOVA with treatment as factor was used to calculate p-value.||||0.192
72548110|NCT03179345|144625050|SUPERIORITY||Mean Difference (Net)|0.005|STANDARD_ERROR_OF_MEAN|0.12||0.9697|TWO_SIDED|95.0|-0.241|0.251|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|Attention Span||0.251|-0.241|0.9697
72548111|NCT03179345|144625050|SUPERIORITY||Mean Difference (Net)|-0.086|STANDARD_ERROR_OF_MEAN|0.13||0.5118|TWO_SIDED|95.0|-0.346|0.174|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.||Motivation|SE of difference estimated by dividing width of 95% CI by 4.|0.174|-0.346|0.5118
72548112|NCT03179345|144625051|SUPERIORITY||Mean Difference (Net)|-0.116|STANDARD_ERROR_OF_MEAN|0.53||0.8293|TWO_SIDED|95.0|-1.178|0.947|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|||0.947|-1.178|0.8293
72548113|NCT03179345|144625051|SUPERIORITY||Mean Difference (Net)|-0.02|STANDARD_ERROR_OF_MEAN|0.53||0.9705|TWO_SIDED|95.0|-1.089|1.049|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|||1.049|-1.089|0.9705
72548114|NCT03179345|144625052|SUPERIORITY||Mean Difference (Net)|-0.488|STANDARD_ERROR_OF_MEAN|0.53||0.3666|TWO_SIDED|95.0|-1.556|0.581|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|||0.581|-1.556|0.3666
72548115|NCT03179345|144625052|SUPERIORITY||Mean Difference (Net)|-0.02|STANDARD_ERROR_OF_MEAN|0.53||0.9705|TWO_SIDED|95.0|-1.089|1.049|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|||1.049|-1.089|0.9705
72548116|NCT02300025|144625054|SUPERIORITY_OR_OTHER||LS means ratio|92.2|||||TWO_SIDED|90.0|59.2|143.4|||||The 90% CI for differences in LS means between test and reference treatments obtained from mixed model were also back-transformed to give 90% CIs for the ratio of the test treatment relative to the reference treatment.|Cmax was analyzed using a mixed model analysis of variance (ANOVA) to determine 90% confidence interval (CI) of the ratio between normal hepatic function (reference) and mild hepatic impairment (test) where hepatic impairment group was a fixed factor. The least squares (LS) means of the test and reference treatments obtained from the mixed model were back-transformed to give geometric LS means (a point estimate).||143.4|59.2|
72548117|NCT02300025|144625054|SUPERIORITY_OR_OTHER||LS means ratio|84.9|||||TWO_SIDED|90.0|54.6|132.1|||||The 90% CI for differences in LS means between the test and reference treatments obtained from the mixed model were also back-transformed to give 90% CIs for the ratio of the test treatment relative to the reference treatment.|Cmax was analyzed using a mixed model ANOVA to determine 90% CI of the ratio between normal hepatic function (reference) and moderate hepatic impairment (test) where hepatic impairment group was a fixed factor. The LS means of the test and reference treatments obtained from the mixed model were back-transformed to give geometric LS means (a point estimate).||132.1|54.6|
72548118|NCT02300025|144625054|SUPERIORITY_OR_OTHER||LS means ratio|39.0|||||TWO_SIDED|90.0|25.1|60.7|||||The 90% CI for differences in LS means between the test and reference treatments obtained from the mixed model were also back-transformed to give 90% CIs for the ratio of the test treatment relative to the reference treatment.|Cmax was analyzed using a mixed model ANOVA to determine 90% CI of the ratio between normal hepatic function (reference) and severe hepatic impairment (test) where hepatic impairment group was a fixed factor. The LS means of the test and reference treatments obtained from the mixed model were back-transformed to give geometric LS means (a point estimate).||60.7|25.1|
72548119|NCT02300025|144625056|SUPERIORITY_OR_OTHER||LS means ratio|98.4|||||TWO_SIDED|90.0|52.0|186.0|||||The 90% CI for differences in LS means between the test and reference treatments obtained from the mixed model were also back-transformed to give 90% CIs for the ratio of the test treatment relative to the reference treatment.|AUC (0-t) was analyzed using a mixed model ANOVA to determine 90% CI of the ratio between normal hepatic function (reference) and mild hepatic impairment (test) where, hepatic impairment group was a fixed factor. The LS means of the test and reference treatments obtained from the mixed model were back-transformed to give geometric LS means (a point estimate).||186.0|52.0|
72548120|NCT02300025|144625056|SUPERIORITY_OR_OTHER||LS means ratio|102.2|||||TWO_SIDED|90.0|54.0|193.2|||||The 90% CI for differences in LS means between the test and reference treatments obtained from the mixed model were also back-transformed to give 90% CIs for the ratio of the test treatment relative to the reference treatment.|AUC (0-t) was analyzed using a mixed model ANOVA to determine 90% CI of the ratio between normal hepatic function (reference) and moderate hepatic impairment (test) where, hepatic impairment group was a fixed factor. The LS means of the test and reference treatments obtained from the mixed model were back-transformed to give geometric LS means (a point estimate).||193.2|54.0|
72548121|NCT02300025|144625056|SUPERIORITY_OR_OTHER||LS means ratio|42.5|||||TWO_SIDED|90.0|22.5|80.5|||||The 90% CI for differences in LS means between the test and reference treatments obtained from the mixed model were also back-transformed to give 90% CIs for the ratio of the test treatment relative to the reference treatment.|AUC (0-t) was analyzed using a mixed model ANOVA to determine 90% CI of the ratio between normal hepatic function (reference) and severe hepatic impairment (test) where, hepatic impairment group was a fixed factor. The LS means of the test and reference treatments obtained from the mixed model were back-transformed to give geometric LS means (a point estimate).||80.5|22.5|
72548122|NCT02300025|144625057|SUPERIORITY_OR_OTHER||LS means ratio|97.6|||||TWO_SIDED|90.0|59.3|160.6|||||The 90% CI for differences in LS means between the test and reference treatments obtained from the mixed model were also back-transformed to give 90% CIs for the ratio of the test treatment relative to the reference treatment.|AUC (0 - ∞) was analyzed using a mixed model ANOVA to determine 90% CI of the ratio between normal hepatic function (reference) and mild hepatic impairment (test) where hepatic impairment group was a fixed factor. The LS means of the test and reference treatments obtained from the mixed model were back-transformed to give geometric LS means (a point estimate).||160.6|59.3|
72412341|NCT03855189|144332682|OTHER||||||<|0.01|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||<0.01
72581854|NCT01651117|144694254|EQUIVALENCE|Mixed methods ANCOVA with patient random effects, to compare change in HbA1c from baseline to 6 months between treatment and control groups.|Mean Difference (Final Values)|-0.3268|STANDARD_ERROR_OF_MEAN|0.1739||0.0611|TWO_SIDED|95.0|-0.669|0.0154||Subject random effect included because same model was used for analyses of 2 separate follow up periods (baseline to 6 month, and baseline to 12 month, reported separately).|Mixed Models Analysis|Multiple imputation used for intent-to-treat analysis.|Negative parameter estimate means decrease in HbA1c was greater for treatment group than for control group.|||0.0154|-0.6690|0.0611
72581855|NCT02714218|144694284|SUPERIORITY||Odds Ratio (OR)|0.59||||0.0144|TWO_SIDED|95.0|0.38|0.9|||Cochran-Mantel-Haenszel|Two-sided p-value CMH Test for comparison of odds ratio of NIVO 3 + IPI 1 over NIVO 1 + IPI 3||||0.90|0.38|0.0144
72581856|NCT02714218|144694284|SUPERIORITY||Estimated Difference of rates|-12.7|||||TWO_SIDED|95.0|-22.7|-2.6|||||Estimate of NIVO 3 + IPI 1- NIVO 1 + IPI 3 is based on Cochran-Mantel-Haenszel (CMH) method of weighting, adjusting for PD-L1 expression and M stage at screening as entered into the IVRS|||-2.6|-22.7|
72581857|NCT02714218|144694285|SUPERIORITY||Odds Ratio (OR)|0.55||||0.0059|TWO_SIDED|95.0|0.36|0.84|||Cochran-Mantel-Haenszel|Two-sided p-value CMH Test for comparison of odds ratio of NIVO 3 + IPI 1 over NIVO 1 + IPI 3||||0.84|0.36|0.0059
72581858|NCT02714218|144694285|SUPERIORITY||Estimated Difference of rates|-14.4|||||TWO_SIDED|95.0|-24.5|-4.3|||||Estimate of NIVO 3 + IPI 1- NIVO 1 + IPI 3 is based on Cochran-Mantel-Haenszel (CMH) method of weighting, adjusting for PD-L1 expression and M stage at screening as entered into the IVRS|||-4.3|-24.5|
72581859|NCT02714218|144694286|SUPERIORITY||Odds Ratio (OR)|0.8||||0.2923|TWO_SIDED|95.0|0.53|1.21|||Cochran-Mantel-Haenszel||p-value from CMH Test for the comparison of the odds ratio of N3I1 over N1I3|||1.21|0.53|0.2923
72581860|NCT02714218|144694287|SUPERIORITY||Hazard Ratio (HR)|1.08|||||TWO_SIDED|95.0|0.79|1.47|||||Hazard Ratio is N3I1 over N1I3. (NIVO 3 + IPI 1 (N3I1) over NIVO 1 + IPI 3 (N1I3))|||1.47|0.79|
72581861|NCT02714218|144694288|SUPERIORITY||Hazard Ratio (HR)|1.12||||0.4512|TWO_SIDED|95.0|0.84|1.48|||Log Rank|||||1.48|0.84|0.4512
72581862|NCT01400477|144694328|SUPERIORITY|||||||0.89||||||A priori vape was \<0.05|ANOVA|df 1, 37||||||0.89
72581863|NCT00793455|144694376|SUPERIORITY_OR_OTHER||Rate Ratio|3.1|||<|0.05|TWO_SIDED|95.0|1.5|6.2|||Chi-squared|||We compared the outcomes in the intervention and control groups using rate ratios and chi square test at 3 and 6 months, a 2 sided test with a p value \< .05 was used to determine significance. The study was powered to detect a 10-percentage point difference in screening completion between intervention and control groups if the control rate of completion as 20% or less with 80% power.||6.2|1.5|<0.05
72581864|NCT00793455|144694377|SUPERIORITY_OR_OTHER||Rate Ratio|1.5|||<|0.05|TWO_SIDED|95.0|1.03|2.2|||Chi-squared|||Same as primary outcome.||2.2|1.03|<0.05
72581865|NCT02452476|144694378|SUPERIORITY||Mean Difference (Final Values)|0.02||||0.93|TWO_SIDED|95.0|-0.4|0.44|||Mixed model for repeated measurements|||"Day 1, 30 min post dose.~SpO2/FiO2 and FiO2 (%) over the first 24 hours: analyzed using a linear mixed model for repeated measures (MMRM) including treatment, timepoint, treatment by timepoint interaction, investigational site and gestational age (GA) group as fixed effects, and predose values as covariates. The adjusted mean difference between treatments, and their 95% confidence intervals (CIs) at each timepoint and averaged over the first 24 hours were estimated by the model."||0.44|-0.40|0.930
72581866|NCT02452476|144694378|SUPERIORITY||Mean Difference (Final Values)|-0.19||||0.346|TWO_SIDED|95.0|-0.59|0.21|||Mixed model for repeated measurements|||Day 1, 1 h post dose||0.21|-0.59|0.346
72581867|NCT02452476|144694378|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.549|TWO_SIDED|95.0|-0.43|0.23|||Mixed model for repeated measurements|||Day 1, 3 h post dose||0.23|-0.43|0.549
72581868|NCT02452476|144694378|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.539|TWO_SIDED|95.0|-0.43|0.23|||Mixed model for repeated measurements|||Day 1, 6 h post dose||0.23|-0.43|0.539
72581869|NCT02452476|144694378|SUPERIORITY||Mean Difference (Final Values)|0.11||||0.491|TWO_SIDED|95.0|-0.21|0.43|||Mixed model for repeated measurements|||Day 1, 12 h post dose||0.43|-0.21|0.491
72581870|NCT02452476|144694378|SUPERIORITY||Mean Difference (Final Values)|0.07||||0.623|TWO_SIDED|95.0|-0.22|0.37|||Mixed model for repeated measurements|||Day 1, 18 h post dose||0.37|-0.22|0.623
72581871|NCT02452476|144694378|SUPERIORITY||Mean Difference (Final Values)|0.09||||0.608|TWO_SIDED|95.0|-0.25|0.43|||Mixed model for repeated measurements|||Day 1, 24 h post dose||0.43|-0.25|0.608
72581872|NCT02452476|144694378|SUPERIORITY||Mean Difference (Final Values)|-0.03||||0.869|TWO_SIDED|95.0|-0.35|0.3|||Mixed Models Analysis|||"Day 2, post dose~SpO2/FiO2 was compared between treatments at the remaining post-treatment time points (i.e., Days 2, 3, 5, 7): analyzed using mixed model including treatment, investigational site and gestational age group as fixed effects and pre-dose ratio as covariate."||0.30|-0.35|0.869
72581873|NCT02452476|144694378|SUPERIORITY||Mean Difference (Final Values)|-0.04||||0.833|TWO_SIDED|95.0|-0.38|0.31|||Mixed Models Analysis|||Day 3, post dose||0.31|-0.38|0.833
72412342|NCT03855189|144332682|OTHER|||||||0.01|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||0.01
72581874|NCT02452476|144694378|SUPERIORITY||Mean Difference (Final Values)|-0.05||||0.772|TWO_SIDED|95.0|-0.39|0.29|||Mixed Models Analysis|||Day 5, post dose||0.29|-0.39|0.772
72581875|NCT02452476|144694378|SUPERIORITY||Mean Difference (Final Values)|0.01||||0.963|TWO_SIDED|95.0|-0.33|0.35|||Mixed Models Analysis|||Day 7, post dose||0.35|-0.33|0.963
72581876|NCT02452476|144694379|SUPERIORITY||Mean Difference (Final Values)|-1.94||||0.519|TWO_SIDED|95.0|-7.87|3.99|||Mixed model for repeated measurements|||Day 1, 30 min post dose||3.99|-7.87|0.519
72581877|NCT02452476|144694379|SUPERIORITY||Mean Difference (Final Values)|2.45||||0.282|TWO_SIDED|95.0|-2.04|6.93|||Mixed model for repeated measurements|||Day 1, 1 h post dose||6.93|-2.04|0.282
72548123|NCT02300025|144625057|SUPERIORITY_OR_OTHER||LS means ratio|103.0|||||TWO_SIDED|90.0|62.6|169.6|||||The 90% CI for differences in LS means between the test and reference treatments obtained from the mixed model were also back-transformed to give 90% CIs for the ratio of the test treatment relative to the reference treatment.|AUC (0 - ∞) was analyzed using a mixed model ANOVA to determine 90% CI of the ratio between normal hepatic function (reference) and moderate hepatic impairment (test) where hepatic impairment group was a fixed factor. The LS means of the test and reference treatments obtained from the mixed model were back-transformed to give geometric LS means (a point estimate).||169.6|62.6|
72548124|NCT02300025|144625057|SUPERIORITY_OR_OTHER||LS means ratio|68.5|||||TWO_SIDED|90.0|40.4|116.2|||||The 90% CI for differences in LS means between the test and reference treatments obtained from the mixed model were also back-transformed to give 90% CIs for the ratio of the test treatment relative to the reference treatment.|AUC (0 - ∞) was analyzed using a mixed model ANOVA to determine 90% CI of the ratio between normal hepatic function (reference) and severe hepatic impairment (test) where hepatic impairment group was a fixed factor. The LS means of the test and reference treatments obtained from the mixed model were back-transformed to give geometric LS means (a point estimate).||116.2|40.4|
72548125|NCT00626925|144625063|SUPERIORITY_OR_OTHER|||||||0.001|||||||Mixed Models Analysis|||||||0.001
72548126|NCT00626925|144625064|SUPERIORITY_OR_OTHER|||||||0.01|||||||Mixed Models Analysis|||||||0.01
72548127|NCT00626925|144625066|SUPERIORITY_OR_OTHER|||||||0.004|||||||Mixed Models Analysis|||||||0.004
72548128|NCT00626925|144625067|SUPERIORITY_OR_OTHER|||||||0.04|||||||Mixed Models Analysis|||||||0.04
72412343|NCT03191903|144332686|SUPERIORITY|||||||0.5874|||||||ANOVA|||||||0.5874
72412344|NCT03191903|144332687|SUPERIORITY|||||||0.0829|||||||ANOVA|||||||0.0829
72548129|NCT00626925|144625068|SUPERIORITY_OR_OTHER|||||||0.001|||||||Mixed Models Analysis|||||||0.001
72548130|NCT00626925|144625069|SUPERIORITY_OR_OTHER|||||||0.06|||||||Mixed Models Analysis|||||||0.06
72548131|NCT00626925|144625070|SUPERIORITY_OR_OTHER|||||||0.01|||||||Mixed Models Analysis|||||||0.01
72548132|NCT00780026|144625071|SUPERIORITY_OR_OTHER|||||||0.841||||||P value for Bacterial infection|Chi-squared|||||||0.841
72548133|NCT00780026|144625071|SUPERIORITY_OR_OTHER|||||||0.298||||||P-value for fungal infection|Chi-squared|||||||0.298
72548134|NCT00780026|144625071|SUPERIORITY_OR_OTHER|||||||0.585||||||P value for transplant incision wound|Chi-squared|||||||0.585
72548135|NCT00780026|144625071|SUPERIORITY_OR_OTHER|||||||0.505||||||P value for viral infection|Chi-squared|||||||0.505
72548136|NCT00780026|144625072|SUPERIORITY_OR_OTHER|||||||0.999|||||||Fisher Exact|||||||0.999
72548137|NCT00780026|144625073|EQUIVALENCE|If the p-value for the means is \> 0.05 between the groups then they will be deemed equivalent.||||||0.384|||||||Wilcoxon (Mann-Whitney)|||||||0.384
72548138|NCT00780026|144625075|SUPERIORITY_OR_OTHER|||||||0.401|||||||Fisher Exact|||||||0.401
72548139|NCT00780026|144625076|SUPERIORITY_OR_OTHER|||||||0.826||||||P value for bile leak|Chi-squared|||||||0.826
72548140|NCT00780026|144625076|SUPERIORITY_OR_OTHER|||||||0.137||||||This is the p value for Biliary Stricture|Chi-squared|||||||0.137
72548141|NCT00780026|144625077|SUPERIORITY_OR_OTHER|||||||0.999|||||||Fisher Exact|||||||0.999
72548142|NCT01966042|144625107|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Friedman test (n=13)|||||||< 0.001
72548143|NCT03522948|144625112|SUPERIORITY||Mean Difference (Net)|-3.16|STANDARD_DEVIATION|-0.71||0.03|TWO_SIDED||||||t-test, 2 sided|||within-subject t-test||||.03
72548144|NCT03522948|144625113|SUPERIORITY||t-test|-1.34|STANDARD_DEVIATION|3.2||0.23|TWO_SIDED||||||t-test, 2 sided||||d = -0.51|||0.23
72548145|NCT03522948|144625114|SUPERIORITY||t-test|1.35|||<|0.05|TWO_SIDED|95.0|-0.69|2.41|||t-test, 2 sided|||GSAB self-efficacy||2.41|-0.69|<.05
72548146|NCT03522948|144625115|SUPERIORITY||t-test|2.93|||<|0.05|TWO_SIDED|95.0|0.31|3.41|||t-test, 2 sided|||Test of GSAB self-efficacy subscale for condom use||3.41|0.31|<.05
72548147|NCT01047345|144625129|SUPERIORITY_OR_OTHER||Difference in Percentages|3.5||||0.026|TWO_SIDED|95.0|0.5|6.2|||Miettinen & Nurminen|||||6.2|0.5|0.026
72548148|NCT01047345|144625130|SUPERIORITY_OR_OTHER||Difference in Percentages|4.0|||||TWO_SIDED|95.0|-2.8|10.8|||Miettinen & Nurminen|||||10.8|-2.8|
72548149|NCT01047345|144625131|SUPERIORITY_OR_OTHER||Difference in Percentages|0.0|||||TWO_SIDED|95.0|-1.5|0.9|||Miettinen & Nurminen|||||0.9|-1.5|
72412345|NCT03191903|144332688|SUPERIORITY|||||||0.4673|||||||ANOVA|||||||0.4673
72548150|NCT01047345|144625132|SUPERIORITY_OR_OTHER||Difference in Percentages|-0.2|||||TWO_SIDED|95.0|-1.7|0.6|||Miettinen & Nurminen|||||0.6|-1.7|
72548151|NCT01047345|144625133|SUPERIORITY_OR_OTHER||Difference in Percentages|10.2|||||TWO_SIDED|95.0|7.5|13.1|||Miettinen & Nurminen|||||13.1|7.5|
72548152|NCT01047345|144625134|SUPERIORITY_OR_OTHER||Seroconversion rate|99.8|||<|0.001|TWO_SIDED|95.0|98.9|100.0||statistical criterion of acceptability required that the lower bound of the 95% confidence interval (CI) for the proportion of participants seroconverting be greater than 90%|Clopper-Pearson|||Anti-HPV 31||100.0|98.9|<0.001
72548153|NCT01047345|144625134|SUPERIORITY_OR_OTHER||Seroconversion Rate|99.8|||<|0.001|TWO_SIDED|95.0|98.9|100.0||statistical criterion of acceptability required that the lower bound of the 95% CI for the proportion of subjects seroconverting be greater than 90%|Clopper-Pearson|||Anti-HPV 33||100.0|98.9|<0.001
72548154|NCT01047345|144625134|SUPERIORITY_OR_OTHER||Seroconversion Rate|98.3|||<|0.001|TWO_SIDED|95.0|96.7|99.2||statistical criterion of acceptability required that the lower bound of the 95% CI for the proportion of subjects seroconverting be greater than 90%|Clopper-Pearson|||Anti-HPV 45||99.2|96.7|<0.001
72548155|NCT01047345|144625134|SUPERIORITY_OR_OTHER||Seroconversion Rate|99.6|||<|0.001|TWO_SIDED|95.0|98.6|100.0||statistical criterion of acceptability required that the lower bound of the 95% CI for the proportion of subjects seroconverting be greater than 90%|Clopper-Pearson|||Anti-HPV 52||100.0|98.6|<0.001
72548156|NCT01047345|144625134|SUPERIORITY_OR_OTHER||Seroconversion Rate|99.8|||<|0.001|TWO_SIDED|95.0|98.9|100.0||statistical criterion of acceptability required that the lower bound of the 95% CI for the proportion of subjects seroconverting be greater than 90%|Clopper-Pearson|||Anti-HPV 58||100.0|98.9|<0.001
72548157|NCT00698685|144625138|SUPERIORITY_OR_OTHER||actuarial probability of engraftment|70.0||||||95.0|||||||Actuarial probability of engraftment at day +100 is calculated according to the product-limit estimate method.|||||
72548158|NCT01396044|144625160|SUPERIORITY_OR_OTHER|||||||0.27|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||0.27
72548159|NCT01396044|144625161|SUPERIORITY_OR_OTHER|||||||0.093|TWO_SIDED|95.0|||||t-test, 2 sided|||||||0.093
72548160|NCT01396044|144625162|SUPERIORITY_OR_OTHER|||||||0.17|TWO_SIDED|95.0|||||Chi-squared|||||||0.17
72548161|NCT01396044|144625163|SUPERIORITY_OR_OTHER|||||||0.27||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.27
72548162|NCT01396044|144625164|SUPERIORITY_OR_OTHER|||||||0.36||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.36
72548163|NCT01396044|144625166|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED|95.0|||||Chi-squared|||||||0.002
72548164|NCT01048333|144625171|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.09||||0.002|TWO_SIDED|95.0|1.31|3.35|||Regression, Cox|||||3.35|1.31|0.002
72548165|NCT01048333|144625171|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|6.534||||0.001|TWO_SIDED|95.0|3.55|12.02|||Regression, Cox|||||12.02|3.55|0.001
72548166|NCT01048333|144625171|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|3.127||||0.001|TWO_SIDED|95.0|1.77|5.52|||Regression, Cox|||||5.52|1.77|0.001
72548167|NCT00955747|144625174|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.5|STANDARD_DEVIATION|1.4|<|0.05|TWO_SIDED|95.0|||||ANCOVA|||All tests will be two-tailed. Unless specified otherwise, p-values less than or equal to O.050, when rounded to four decimal places,will be considered statistically significant.||||<0.05
72548168|NCT00539539|144625175|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.001||||0.96|TWO_SIDED|95.0|-0.04|0.05|||t-test, 2 sided|||Average change in cluster-specific rates of ROSC.||0.05|-0.04|0.96
72548169|NCT00539539|144625176|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.8||||0.71|TWO_SIDED|95.0|-4.9|3.4|||t-test, 2 sided|||Average difference in cluster-specific rates.||3.4|-4.9|0.71
72548170|NCT00539539|144625177|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.015||||0.21|TWO_SIDED|95.0|-0.039|0.009|||t-test, 2 sided|By-cluster difference in outcome rates.||Average change in cluster-specific risk difference.||0.009|-0.039|0.21
72548171|NCT00539539|144625178|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.9||||0.016|TWO_SIDED|95.0|0.4|3.4|||Regression, Linear|Difference in means, adjusted for cluster.||Cluster adjusted difference in average CPR fraction.||3.4|0.4|0.016
72548172|NCT00539539|144625179|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.6||||0.005|TWO_SIDED|95.0|0.5|2.7|||Regression, Linear|Adjusted for randomization by cluster.||Cluster adjusted difference in means.||2.7|0.5|0.005
72548173|NCT00539539|144625180|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.7|||<|0.001|TWO_SIDED|95.0|-6.4|-3.0|||Regression, Linear|||Cluster adjusted difference in average compression rate.||-3.0|-6.4|<0.001
72548174|NCT00539539|144625181|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.4|||<|0.001|TWO_SIDED|95.0|-5.2|-1.5|||Regression, Linear|||Cluster adjusted difference in the average rate.||-1.5|-5.2|<0.001
72548175|NCT00539539|144625182|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.1||||0.73|TWO_SIDED|95.0|-0.5|0.7|||Regression, Linear|||Cluster adjusted difference in average rate.||0.7|-0.5|0.73
72548176|NCT00767325|144625185|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|0.282|||TWO_SIDED|95.0|-1.2|-0.1|||||Day 7|||-0.1|-1.2|
72548177|NCT00767325|144625185|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.3|STANDARD_ERROR_OF_MEAN|0.308|||TWO_SIDED|95.0|-2.0|-0.7|||||Day 15|||-0.7|-2.0|
72548178|NCT00767325|144625185|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.4|STANDARD_ERROR_OF_MEAN|0.383|||TWO_SIDED|95.0|-3.2|-1.7|||||Day 29|||-1.7|-3.2|
72581878|NCT02452476|144694379|SUPERIORITY||Mean Difference (Final Values)|0.41||||0.854|TWO_SIDED|95.0|-4.04|4.86|||Mixed model for repeated measurements|||Day 1, 3 h post dose||4.86|-4.04|0.854
72581879|NCT02452476|144694379|SUPERIORITY||Mean Difference (Final Values)|-0.41||||0.861|TWO_SIDED|95.0|-5.0|4.19|||Mixed model for repeated measurements|||Day 1, 6 h post dose||4.19|-5.00|0.861
72412346|NCT03191903|144332689|SUPERIORITY|||||||0.9408|||||||ANOVA|||||||0.9408
72548179|NCT00767325|144625185|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.9|STANDARD_ERROR_OF_MEAN|0.384|||TWO_SIDED|95.0|-3.7|-2.1|||||Day 43|||-2.1|-3.7|
72581880|NCT02452476|144694379|SUPERIORITY||Mean Difference (Final Values)|-2.77||||0.117|TWO_SIDED|95.0|-6.24|0.7|||Mixed model for repeated measurements|||Day 1, 12 h post dose||0.70|-6.24|0.117
72548180|NCT00767325|144625185|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.2|STANDARD_ERROR_OF_MEAN|0.393|||TWO_SIDED|95.0|-4.0|-2.4|||||Day 57|||-2.4|-4.0|
72548181|NCT00767325|144625185|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.8|STANDARD_ERROR_OF_MEAN|0.454|||TWO_SIDED|95.0|-4.7|-2.9|||||Day 85|||-2.9|-4.7|
72548182|NCT00767325|144625185|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.5|STANDARD_ERROR_OF_MEAN|0.472|||TWO_SIDED|95.0|-5.4|-3.5|||||Day 113|||-3.5|-5.4|
72581881|NCT02452476|144694379|SUPERIORITY||Mean Difference (Final Values)|-1.92||||0.185|TWO_SIDED|95.0|-4.79|0.94|||Mixed model for repeated measurements|||Day 1, 18 h post dose||0.94|-4.79|0.185
72581882|NCT02452476|144694379|SUPERIORITY||Mean Difference (Final Values)|-1.01||||0.678|TWO_SIDED|95.0|-5.82|3.8|||Mixed model for repeated measurements|||Day 1, 24 h post dose||3.80|-5.82|0.678
72581883|NCT02452476|144694379|SUPERIORITY||Mean Difference (Final Values)|0.09||||0.961|TWO_SIDED|95.0|-3.49|3.67|||Mixed Models Analysis|||"Day 2, post dose~SpO2/FiO2 was compared between treatments at the remaining post-treatment time points (i.e., Days 2, 3, 5, 7): analyzed using mixed model including treatment, investigational site and gestational age group as fixed effects and pre-dose ratio as covariate."||3.67|-3.49|0.961
72412347|NCT03191903|144332690|SUPERIORITY|||||||0.777|||||||ANOVA|||||||0.7770
72412348|NCT03191903|144332691|SUPERIORITY|||||||0.759|||||||ANOVA|||||||0.7590
72412349|NCT03191903|144332692|SUPERIORITY|||||||0.8309|||||||ANOVA|||||||0.8309
72548183|NCT00767325|144625185|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.8|STANDARD_ERROR_OF_MEAN|0.492|||TWO_SIDED|95.0|-5.8|-3.8|||||Day 141|||-3.8|-5.8|
72548184|NCT00767325|144625185|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.8|STANDARD_ERROR_OF_MEAN|0.473|||TWO_SIDED|95.0|-5.8|-3.9|||||Day 169|||-3.9|-5.8|
72552702|NCT00322465|144636214|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.2||||0.009|TWO_SIDED|95.0|0.06|0.66||A priori threshold for statistical significance was p\<0.05.|Regression, Logistic|Odds ratio has been adjusted for other independent variables included in the model, which are found in the other Statistical Analysis sections.||The null hypothesis is that the odds ratio for 2 or more sex partners in the last 3 months (reference category is 0-1 partners) is 1 versus the alternative that it is greater than or less than 1. This was tested in a multivariable logistic regression model.||0.66|0.06|0.009
72581884|NCT02452476|144694379|SUPERIORITY||Mean Difference (Final Values)|-1.53||||0.544|TWO_SIDED|95.0|-6.53|3.46|||Mixed Models Analysis|||Day 3, post dose||3.46|-6.53|0.544
72581885|NCT02452476|144694379|SUPERIORITY||Mean Difference (Final Values)|1.74||||0.492|TWO_SIDED|95.0|-3.28|6.76|||Mixed Models Analysis|||Day 5, post dose||6.76|-3.28|0.492
72581886|NCT02452476|144694379|SUPERIORITY||Mean Difference (Final Values)|1.23||||0.634|TWO_SIDED|95.0|-3.9|6.36|||Mixed Models Analysis|||Day 7, post dose||6.36|-3.90|0.634
72581887|NCT02452476|144694380|SUPERIORITY|Mortality or BPD incidence at 36-week PMA was compared by treatment, using Cochran-Mantel-Haenszel (CMH), adjusting for stratification gestational age (GA) group. Relative risk (RR) and its 95% confidence interval are also provided.|Relative risk|1.03||||0.811|TWO_SIDED|95.0|0.81|1.32|||Cochran-Mantel-Haenszel|||Week 36 PMA Incidence of BPD||1.32|0.81|0.811
72581888|NCT02452476|144694380|SUPERIORITY||Relative risk|1.0||||0.972|TWO_SIDED|95.0|0.81|1.25|||Cochran-Mantel-Haenszel|||Week 36 PMA Incidence of Mortality/BPD||1.25|0.81|0.972
72581889|NCT02452476|144694380|SUPERIORITY||Relative risk|0.74||||0.619|TWO_SIDED|95.0|0.23|2.42|||Cochran-Mantel-Haenszel|||Week 36 PMA Mortality||2.42|0.23|0.619
72581890|NCT02452476|144694380|SUPERIORITY||Relative risk|1.46||||0.602|TWO_SIDED|95.0|0.35|6.09|||Cochran-Mantel-Haenszel|||Day 28 PNA Mortality||6.09|0.35|0.602
72581891|NCT02452476|144694380|SUPERIORITY||Relative risk|0.56||||0.606|TWO_SIDED|95.0|0.06|5.29|||Cochran-Mantel-Haenszel|||Day 14 PNA RDS-associated mortality in 14 days of life||5.29|0.06|0.606
72412350|NCT03191903|144332693|SUPERIORITY|||||||0.6215|||||||ANOVA|||||||0.6215
72548185|NCT02260492|144625211|EQUIVALENCE|"Equivalence test compares the Test/Reference with confidence bounds set at standard 80-125%.~Superiority test compares Test with Placebo (p\<0.05) Superiority test compares Reference with Placebo (p\<0.05) (p\<0.05)"|Test/Reference|1.0799|||<|0.05|TWO_SIDED|90.0|0.8|1.25|||ANCOVA|||"Primary analyses were conducted on BL subtracted values (pre-dose - post-dose). The two one-sided tests method of interval analysis is standard for bioequivalence testing and employs 2 sets of one-sided hypotheses as follows, performed at the 5% alpha level:~H01: uT-uR \< -0.20 uR vs. Ha1: -0.20 uR \</= uT- uR (the lower tail) and H02: uT-uR \>0.25 uR vs. Ha2: uT- uR \</=0.25 uR (the upper tail) When uT is the LSM SOLIS, uR is the LSM of ADVAIR DISKUS"|"Day 1 superiority to placebo:~Solis vs. Placebo p=0.004 Advair vs. Placebo p=0.012"|1.25|.8|<0.05
72548186|NCT02260492|144625212|EQUIVALENCE|Standard bioequivalence 90% confidence bounds set at 0.8-1.25.|Test/Reference|1.0475|||<|0.05|TWO_SIDED|90.0|0.8|1.25|||ANOVA|||Same as the Day 1 analyses|"Week 4 superiority to placebo:~Solis vs. Placebo p=0.019 Advair vs. Placebo p=0.035"|1.25|.8|<0.05
72548187|NCT00996736|144625215|NON_INFERIORITY_OR_EQUIVALENCE|The pre-specified non-inferiority margin is less than 1.5 lines logMAR acuity. (Adjusted three-month visual acuity confidence bounds for the difference between the voriconazole and natamycin groups which meet or exceed 0.15 logMAR units would not permit noninferiority to be declared.) Note that this design also allows declaration of superiority (2-sided alpha of 0.05, corrected for an interim analysis).|Mean Difference (Net)|-0.18||||0.006|TWO_SIDED|95.0|-0.3|-0.05|||Regression, Linear|||||-0.05|-0.30|0.006
72548188|NCT03482713|144625231|OTHER||Difference in least squares means|0.79|||||TWO_SIDED|95.0|-0.34|1.93|||||Based on an ANCOVA model with terms for treatment, gender and the log-transformed baseline.|||1.93|-0.34|
72548189|NCT03482713|144625232|OTHER||Difference least squares mean|0.76|||||TWO_SIDED|95.0|-0.35|1.88|||||Based on an ANCOVA model with terms for treatment, gender and the log-transformed baseline.|||1.88|-0.35|
72548190|NCT01497938|144625233|NON_INFERIORITY_OR_EQUIVALENCE|pre-specified non-inferiority margin of 0.4% was used for sample size calculation. sample size is based on two-sample t test with one-sided type 1 error of 2.5%. Assuming a same mean of change in A1C for the treatment arm and control arm and a common standard deviation of 1% for both treatment groups, it showed that a total of 200 subjects will provide over 80% power to detect the non-inferiority with a margin of 0.4%|Mean Difference (Final Values)|0.05|||||ONE_SIDED|97.5||0.15|||ANCOVA|||||0.15||
72548191|NCT01497938|144625234|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-588.0|||<|0.025||95.0|||||ANCOVA|||||||<0.025
72412351|NCT03191903|144332694|SUPERIORITY|||||||0.216|||||||ANOVA|||||||0.2160
72412352|NCT03191903|144332695|SUPERIORITY|||||||0.7026|||||||ANOVA|||||||0.7026
72412353|NCT03191903|144332696|SUPERIORITY|||||||0.0438|||||||ANOVA|||||||0.0438
72581892|NCT02452476|144694381|SUPERIORITY||Odds Ratio (OR)|0.69||||0.409|TWO_SIDED|95.0|0.3|1.57|||Fisher Exact|||||1.57|0.30|0.409
72581893|NCT02452476|144694382|SUPERIORITY|The percentage of patients requiring at least one rescue surfactant dose were compared by treatment group using the Fisher's exact test at 5% significance interval. Odds ratio (OR) and related exact 95% CI are also provided.|Odds Ratio (OR)|1.21||||0.689|TWO_SIDED|95.0|0.55|2.67|||Fisher Exact|||The percentage of patients requiring at least one rescue surfactant dose.||2.67|0.55|0.689
72581894|NCT02452476|144694383|SUPERIORITY|||||||0.935|||||||Wilcoxon (Mann-Whitney)|||||||0.935
72581895|NCT04052620|144694386|NON_INFERIORITY|Non-inferiority criteria: if the upper 95% Confidence Interval (CI) of Least Square (LS) mean difference was less than 13 mm then DDEA 2.32% gel BID was concluded as non-inferior.|Mean Difference (Final Values)|1.11|STANDARD_ERROR_OF_MEAN|2.09||0.595|TWO_SIDED|95.0|-3.0|5.22|||ANCOVA|||||5.22|-3.00|0.5950
72581896|NCT04052620|144694388|OTHER||Mean Difference (Final Values)|-2.43|STANDARD_ERROR_OF_MEAN|2.12||0.2536|TWO_SIDED|95.0|-6.61|1.75|||ANCOVA||DDEA 2.32% gel vs DDEA 1.16% gel, Day 3|||1.75|-6.61|0.2536
72581897|NCT04052620|144694388|OTHER||Mean Difference (Final Values)|-0.76|STANDARD_ERROR_OF_MEAN|1.76||0.6643|TWO_SIDED|95.0|-4.23|2.7|||ANCOVA||DDEA 2.32% gel vs DDEA 1.16% gel, Day 8|||2.70|-4.23|0.6643
72581898|NCT04052620|144694389|OTHER||Mean Difference (Final Values)|1.2|STANDARD_ERROR_OF_MEAN|1.19||0.3118|TWO_SIDED|95.0|-1.13|3.54|||ANCOVA||DDEA 2.32% gel vs DDEA 1.16% gel, Day 3|||3.54|-1.13|0.3118
72581899|NCT04052620|144694389|OTHER||Mean Difference (Final Values)|-0.93|STANDARD_ERROR_OF_MEAN|1.35||0.4937|TWO_SIDED|95.0|-3.6|1.74|||ANCOVA||DDEA 2.32% gel vs DDEA 1.16% gel, Day 5|||1.74|-3.60|0.4937
72581900|NCT04052620|144694389|OTHER||Mean Difference (Final Values)|1.46|STANDARD_ERROR_OF_MEAN|1.67||0.3825|TWO_SIDED|95.0|-1.83|4.74|||ANCOVA||DDEA 2.32% gel vs DDEA 1.16% gel, Day 8|||4.74|-1.83|0.3825
72581901|NCT04052620|144694390|OTHER||Mean Difference (Final Values)|0.26|STANDARD_ERROR_OF_MEAN|1.26||0.836|TWO_SIDED|95.0|-2.23|2.75|||ANCOVA||DDEA 2.32% gel vs DDEA 1.16% gel, Day 3|||2.75|-2.23|0.8360
72581902|NCT04052620|144694390|OTHER||Mean Difference (Final Values)|-1.25|STANDARD_ERROR_OF_MEAN|1.24||0.3119|TWO_SIDED|95.0|-3.69|1.18|||ANCOVA||DDEA 2.32% gel vs DDEA 1.16% gel, Day 5|||1.18|-3.69|0.3119
72581903|NCT04052620|144694390|OTHER||Mean Difference (Final Values)|1.66|STANDARD_ERROR_OF_MEAN|1.45||0.2535|TWO_SIDED|95.0|-1.2|4.52|||ANCOVA||DDEA 2.32% gel vs DDEA 1.16% gel, Day 8|||4.52|-1.20|0.2535
72581904|NCT04052620|144694391|OTHER||Mean Difference (Final Values)|0.74|STANDARD_ERROR_OF_MEAN|1.51||0.6242|TWO_SIDED|95.0|-2.23|3.71|||ANCOVA||DDEA 2.32% gel vs DDEA 1.16% gel, Day 3|||3.71|-2.23|0.6242
72581905|NCT04052620|144694391|OTHER||Mean Difference (Final Values)|-0.28|STANDARD_ERROR_OF_MEAN|2.06||0.8905|TWO_SIDED|95.0|-4.33|3.77|||ANCOVA||DDEA 2.32% gel vs DDEA 1.16% gel, Day 5|||3.77|-4.33|0.8905
72581906|NCT04052620|144694391|OTHER||Mean Difference (Final Values)|2.12|STANDARD_ERROR_OF_MEAN|2.24||0.3439|TWO_SIDED|95.0|-2.29|6.54|||ANCOVA||DDEA 2.32% gel vs DDEA 1.16% gel, Day 8|||6.54|-2.29|0.3439
72581907|NCT04052620|144694392|OTHER||Mean Difference (Final Values)|-0.18|STANDARD_ERROR_OF_MEAN|0.13||0.1554|TWO_SIDED|95.0|-0.44|0.07|||ANCOVA||DDEA 2.32% gel vs DDEA 1.16% gel, Day 3|||0.07|-0.44|0.1554
72581908|NCT04052620|144694392|OTHER||Mean Difference (Final Values)|-0.39|STANDARD_ERROR_OF_MEAN|0.14||0.0047|TWO_SIDED|95.0|-0.66|-0.12|||ANCOVA||DDEA 2.32% gel vs DDEA 1.16% gel, Day 5|||-0.12|-0.66|0.0047
72581909|NCT04052620|144694392|OTHER||Mean Difference (Final Values)|-0.38|STANDARD_ERROR_OF_MEAN|0.14||0.0082|TWO_SIDED|95.0|-0.66|-0.1|||ANCOVA||DDEA 2.32% gel vs DDEA 1.16% gel, Day 8|||-0.10|-0.66|0.0082
72581910|NCT04052620|144694393|OTHER||Mean Difference (Final Values)|-0.11|STANDARD_ERROR_OF_MEAN|0.09||0.2182|TWO_SIDED|95.0|-0.3|0.07|||ANCOVA||DDEA 2.32% gel vs DDEA 1.16% gel, Day 3|||0.07|-0.30|0.2182
72581911|NCT04052620|144694393|OTHER||Mean Difference (Final Values)|-0.18|STANDARD_ERROR_OF_MEAN|0.09||0.0574|TWO_SIDED|95.0|-0.36|0.01|||ANCOVA||DDEA 2.32% gel vs DDEA 1.16% gel, Day 5|||0.01|-0.36|0.0574
72581912|NCT04052620|144694393|OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.08||0.0194|TWO_SIDED|95.0|-0.37|-0.03|||ANCOVA||DDEA 2.32% gel vs DDEA 1.16% gel, Day 8|||-0.03|-0.37|0.0194
72581913|NCT04052620|144694394|OTHER||Mean Difference (Final Values)|0.37|STANDARD_ERROR_OF_MEAN|0.821||0.6545|TWO_SIDED|95.0|-1.25|1.986|||ANCOVA||DDEA 2.32% gel vs DDEA 1.16% gel, Day 1|||1.986|-1.250|0.6545
72581914|NCT04052620|144694394|OTHER||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|0.721||0.4924|TWO_SIDED|95.0|-1.915|0.924|||ANCOVA||DDEA 2.32% gel vs DDEA 1.16% gel, Day 5|||0.924|-1.915|0.4924
72581915|NCT04052620|144694395|OTHER||Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.823||0.9491|TWO_SIDED|95.0|-1.675|1.57|||ANCOVA||DDEA 2.32% gel vs DDEA 1.16% gel, Day 1|||1.570|-1.675|0.9491
72581916|NCT04052620|144694395|OTHER||Mean Difference (Final Values)|0.8|STANDARD_ERROR_OF_MEAN|1.451||0.582|TWO_SIDED|95.0|-2.059|3.659|||ANCOVA||DDEA 2.32% gel vs DDEA 1.16% gel, Day 5|||3.659|-2.059|0.5820
72581917|NCT01112059|144694447|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.5|||<|0.05|TWO_SIDED|95.0|0.128|0.633|||Wilcoxon (Mann-Whitney)|||||0.633|0.128|<0.05
72548192|NCT00365352|144625235|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.5||||0.0015||95.0|-5.6|-1.3|||ANCOVA||Mean difference was adjusted for Baseline value, treatment pooled sites, and treatment by pool site interaction.|||-1.3|-5.6|0.0015
72548193|NCT00365352|144625236|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.287||||0.0001||95.0|2.338|7.861|||Regression, Logistic|A logistic regression model was used with treatment and pooled center as explanatory factors.||||7.861|2.338|0.0001
72548194|NCT01024738|144625325|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANOVA|||The null hypothesis states that there is no difference between groups.||||0.05
72548195|NCT01700621|144625337|NON_INFERIORITY|A noninferiority margin of -10% was chosen as the maximal absolute reduction in proportion seroprotection allowed in the concomitant measles-rubella and rotavirus vaccine group as compared to the measles-rubella vaccine alone group.|Seroconversion proportion difference|1.1|||||TWO_SIDED|95.0|-6.9|9.0||||||||9.0|-6.9|
72548196|NCT00625807|144625429|OTHER||||||>|0.1||||||Cohen's d = 0.5|ANOVA|||ANOVA for group by time interaction||||> 0.1
72548197|NCT00625807|144625430|OTHER|||||||0.103|||||||ANOVA|||||||0.103
72548198|NCT00625807|144625431|OTHER|||||||0.022|||||||t-test, 2 sided|||within group change pre to week 8||||.022
72548199|NCT00625807|144625431|OTHER|within group change from pre to week 8|||||<|0.001|||||||t-test, 2 sided|||||||<.001
72548200|NCT00625807|144625432|OTHER|||||||0.015|||||||t-test, 2 sided|||within group change from pre to week 8||||.015
72548201|NCT00625807|144625432|OTHER|||||||0.53|||||||t-test, 2 sided|||within group change from pre to week 8||||.53
72548202|NCT00625807|144625433|OTHER|||||||0.06|||||||t-test, 2 sided|||within group change from pre to week 8||||.06
72548203|NCT00625807|144625433|OTHER||||||<|0.001|||||||t-test, 2 sided|||within group change from pre to post||||<.001
72548204|NCT00108732|144625454|SUPERIORITY_OR_OTHER||Percent|62.5|||||TWO_SIDED|90.0|48.3|75.3||||||||75.3|48.3|
72548205|NCT00108732|144625455|SUPERIORITY_OR_OTHER||Response rate (percent)|0.0|||||TWO_SIDED|90.0|0.0|7.2||||||||7.2|0|
72548206|NCT00108732|144625456|SUPERIORITY_OR_OTHER||median of difference|0.45||||0.003||95.0|||||Wilcoxon signed rank test|The Wilcoxon signed rank test was used to test the difference between day 4 PSA and day 15 PSA.||||||0.003
72548207|NCT00108732|144625457|SUPERIORITY_OR_OTHER||median of difference|-0.04||||0.02||95.0||||The Wilcoxon signed-rank test was used to test the difference between pre and post-treatment PSA slopes assessed by multiple PSA values on natural log scale using a piecewise linear model with a common knot point at the date of registration.|Wilcoxon signed rank test|||||||0.02
72548208|NCT01984242|144625506|SUPERIORITY||Hazard Ratio (HR)|1.0||||0.9819|TWO_SIDED|95.0|0.69|1.45|||Log Rank|||||1.45|0.69|0.9819
72548209|NCT01984242|144625506|SUPERIORITY||Hazard Ratio (HR)|1.19||||0.358|TWO_SIDED|95.0|0.82|1.71|||Log Rank|||||1.71|0.82|0.3580
72548210|NCT01984242|144625508|SUPERIORITY||Hazard Ratio (HR)|0.64||||0.0952||95.0|0.38|1.08|||Log Rank|||||1.08|0.38|0.0952
72581918|NCT02654054|144694450|SUPERIORITY||Odds Ratio (OR)|56.79|||<|0.001|TWO_SIDED|95.0|23.002|140.227||The P value for test of difference is by pooling the results from a logistic regression model including treatment as the main effect and baseline MBL volume as a covariate in each data set from multiple imputation.|Regression, Logistic|||||140.227|23.002|< 0.001
72548211|NCT01984242|144625508|SUPERIORITY||Hazard Ratio (HR)|1.03||||0.9172|TWO_SIDED|95.0|0.63|1.67|||Log Rank|||||1.67|0.63|0.9172
72548212|NCT01984242|144625510|SUPERIORITY||Hazard Ratio (HR)|0.48||||0.0153|TWO_SIDED|95.0|0.26|0.87|||Log Rank|||||0.87|0.26|0.0153
72548213|NCT01984242|144625510|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.5545|TWO_SIDED|95.0|0.48|1.46|||Log Rank|||||1.46|0.48|0.5545
72581919|NCT02654054|144694450|SUPERIORITY||Odds Ratio (OR)|22.98|||<|0.001|TWO_SIDED|95.0|10.466|50.451||The P value for test of difference is by pooling the results from a logistic regression model including treatment as the main effect and baseline MBL volume as a covariate in each data set from multiple imputation.|Regression, Logistic|||||50.451|10.466|< 0.001
72581920|NCT02654054|144694451|SUPERIORITY||LS Mean of Difference|-222.3|STANDARD_ERROR_OF_MEAN|20.77|<|0.001|TWO_SIDED|||||The P value for test of difference between each elagolix treatment group and placebo is by pooling the results from an ANCOVA model with treatment as the main effect and baseline MBL volume as a covariate in each dataset from multiple imputation.|ANCOVA|||||||< 0.001
72581921|NCT02654054|144694451|SUPERIORITY||LS Mean of Difference|-177.5|STANDARD_ERROR_OF_MEAN|18.24|<|0.001|TWO_SIDED|||||The P value for test of difference between each elagolix treatment group and placebo is by pooling the results from an ANCOVA model with treatment as the main effect and baseline MBL volume as a covariate in each dataset from multiple imputation.|ANCOVA|||||||< 0.001
72548214|NCT01984242|144625512|SUPERIORITY||Hazard Ratio (HR)|0.49||||0.0086|TWO_SIDED|95.0|0.28|0.84|||Log Rank|||||0.84|0.28|0.0086
72548215|NCT01984242|144625512|SUPERIORITY||Hazard Ratio (HR)|0.93||||0.7675||95.0|0.56|1.53|||Log Rank|||||1.53|0.56|0.7675
72548216|NCT01984242|144625514|SUPERIORITY||Hazard Ratio (HR)|0.72||||0.1973||95.0|0.44|1.18|||Log Rank|||||1.18|0.44|0.1973
72548217|NCT01984242|144625514|SUPERIORITY||Hazard Ratio (HR)|1.07||||0.7738|TWO_SIDED|95.0|0.65|1.76|||Log Rank|||||1.76|0.65|0.7738
72548218|NCT01984242|144625516|SUPERIORITY||Hazard Ratio (HR)|0.68||||0.083||95.0|0.43|1.06|||Log Rank|||||1.06|0.43|0.0830
72548219|NCT01984242|144625516|SUPERIORITY||Hazard Ratio (HR)|1.09||||0.7141|TWO_SIDED|95.0|0.7|1.69|||Log Rank|||||1.69|0.70|0.7141
72548220|NCT01984242|144625518|SUPERIORITY||Hazard Ratio (HR)|0.82||||0.2541||95.0|0.59|1.15|||Log Rank|||||1.15|0.59|0.2541
72548221|NCT01984242|144625518|SUPERIORITY||Hazard Ratio (HR)|1.18||||0.3103|TWO_SIDED|95.0|0.86|1.63|||Log Rank|||||1.63|0.86|0.3103
72548222|NCT01984242|144625520|SUPERIORITY||Hazard Ratio (HR)|0.6||||0.0351|TWO_SIDED|95.0|0.37|0.97|||Log Rank|||||0.97|0.37|0.0351
72548223|NCT01984242|144625520|SUPERIORITY||Hazard Ratio (HR)|0.99||||0.9769||95.0|0.64|1.54|||Log Rank|||||1.54|0.64|0.9769
72548224|NCT01984242|144625521|SUPERIORITY||Difference in response rates|2.97||||0.6492|TWO_SIDED|95.0|-10.68|16.62|||Cochran-Mantel-Haenszel|||||16.62|-10.68|0.6492
72548225|NCT01984242|144625521|SUPERIORITY||Difference in response rates|-3.47||||0.5433||95.0|-16.63|9.69|||Cochran-Mantel-Haenszel|||||9.69|-16.63|0.5433
72548226|NCT01984242|144625522|SUPERIORITY||Difference in response rates|19.33||||0.0141|TWO_SIDED|95.0|-0.28|38.94|||Cochran-Mantel-Haenszel|||||38.94|-0.28|0.0141
72581922|NCT02654054|144694452|SUPERIORITY||Between-Group Difference (%)|79.6|||<|0.001|TWO_SIDED|95.0|71.13|88.16||The P value is calculated based on chi-square test (or Fisher's exact test if ≥ 20% of the cells have expected cell count \< 5).|Chi-square or Fisher's exact test|||||88.16|71.13|< 0.001
72581923|NCT02654054|144694452|SUPERIORITY||Between-Group Difference (%)|52.4|||<|0.001|TWO_SIDED|95.0|44.11|60.76||The P value is calculated based on chi-square test (or Fisher's exact test if ≥ 20% of the cells have expected cell count \< 5).|Chi-square or Fisher's exact test|||||60.76|44.11|< 0.001
72548227|NCT01984242|144625522|SUPERIORITY||Difference in response rates|1.11||||0.8719|TWO_SIDED|95.0|-17.02|19.24|||Cochran-Mantel-Haenszel|||||19.24|-17.02|0.8719
72548228|NCT01984242|144625523|SUPERIORITY||Difference in response rates|1.98||||0.8068|TWO_SIDED|95.0|-12.04|16.0|||Cochran-Mantel-Haenszel|||||16.00|-12.04|0.8068
72548229|NCT01984242|144625523|SUPERIORITY||Difference in response rates|-9.37||||0.1321||95.0|-22.61|3.87|||Cochran-Mantel-Haenszel|||||3.87|-22.61|0.1321
72548230|NCT01984242|144625524|SUPERIORITY||Difference in response rates|19.67||||0.0199|TWO_SIDED|95.0|-0.1|39.44|||Cochran-Mantel-Haenszel|||||39.44|-0.10|0.0199
72548231|NCT01984242|144625524|SUPERIORITY||Difference in response rates|-2.41||||0.7836|TWO_SIDED|95.0|-20.5|15.68|||Cochran-Mantel-Haenszel|||||15.68|-20.50|0.7836
72548232|NCT01984242|144625525|SUPERIORITY||Difference in response rates|3.96||||0.6231|TWO_SIDED|95.0|-10.23|18.15|||Cochran-Mantel-Haenszel|||||18.15|-10.23|0.6231
72548233|NCT01984242|144625525|SUPERIORITY||Difference in response rates|-8.42||||0.1816|TWO_SIDED|95.0|-21.86|5.02|||Cochran-Mantel-Haenszel|||||5.02|-21.86|0.1816
72548234|NCT01984242|144625526|SUPERIORITY||Difference in response rates|22.0||||0.0111|TWO_SIDED|95.0|2.11|41.89|||Cochran-Mantel-Haenszel|||||41.89|2.11|0.0111
72548235|NCT01984242|144625526|SUPERIORITY||Difference in response rates|-2.22||||0.8209|TWO_SIDED|95.0|-20.63|16.19|||Cochran-Mantel-Haenszel|||||16.19|-20.63|0.8209
72548236|NCT01984242|144625528|SUPERIORITY||Hazard Ratio (HR)|0.72||||0.0863||95.0|0.5|1.05|||Log Rank|||||1.05|0.50|0.0863
72548237|NCT01984242|144625528|SUPERIORITY||Hazard Ratio (HR)|1.1||||0.5922|TWO_SIDED|95.0|0.77|1.57|||Log Rank|||||1.57|0.77|0.5922
72548238|NCT01984242|144625530|SUPERIORITY||Hazard Ratio (HR)|0.43||||0.0021||95.0|0.25|0.75|||Log Rank|||||0.75|0.25|0.0021
72548239|NCT01984242|144625530|SUPERIORITY||Hazard Ratio (HR)|0.9||||0.6566|TWO_SIDED|95.0|0.56|1.44|||Log Rank|||||1.44|0.56|0.6566
72581924|NCT02654054|144694453|SUPERIORITY||LS Mean of Difference|-234.0|STANDARD_ERROR_OF_MEAN|19.27|<|0.001|TWO_SIDED|||||The P value is from mixed models repeated measures (MMRM) with treatment, month, and an interaction between treatment and month as fixed effect factors, and baseline MBL volume as a covariate comparing each elagolix treatment group with placebo.|mixed model repeated measures|||||||< 0.001
72581925|NCT02654054|144694453|SUPERIORITY||LS Mean of Difference|-192.5|STANDARD_ERROR_OF_MEAN|16.7|<|0.001|TWO_SIDED|||||The P value is from mixed models repeated measures (MMRM) with treatment, month, and an interaction between treatment and month as fixed effect factors, and baseline MBL volume as a covariate comparing each elagolix treatment group with placebo.|mixed model repeated measures|||||||< 0.001
72581926|NCT02654054|144694454|SUPERIORITY||LS Mean of Difference|-240.8|STANDARD_ERROR_OF_MEAN|21.69|<|0.001|TWO_SIDED|||||The P value is from MMRM with treatment, month, and an interaction between treatment and month as fixed effect factors, and baseline MBL volume as a covariate comparing each elagolix treatment group with placebo.|mixed model repeated measures|||||||< 0.001
72581927|NCT02654054|144694454|SUPERIORITY||LS Mean of Difference|-198.2|STANDARD_ERROR_OF_MEAN|18.76|<|0.001|TWO_SIDED|||||The P value is from MMRM with treatment, month, and an interaction between treatment and month as fixed effect factors, and baseline MBL volume as a covariate comparing each elagolix treatment group with placebo.|mixed model repeated measures|||||||< 0.001
72581928|NCT02654054|144694455|SUPERIORITY||Between-Group Difference (%)|49.7|||<|0.001|TWO_SIDED|95.0|30.27|69.18||The P value is calculated based on chi-square test (or Fisher's exact test if ≥ 20% of the cells have expected cell count \< 5).|chi-square or Fisher's exact test|||||69.18|30.27|< 0.001
72581929|NCT02654054|144694455|SUPERIORITY||Between-Group Difference (%)|45.4|||<|0.001|TWO_SIDED|95.0|26.9|63.92||The P value is calculated based on chi-square test (or Fisher's exact test if ≥ 20% of the cells have expected cell count \< 5).|chi-square or Fisher's exact test|||||63.92|26.90|< 0.001
72581930|NCT02654054|144694456|SUPERIORITY||LS Mean of Difference|-190.0|STANDARD_ERROR_OF_MEAN|22.59|<|0.001|TWO_SIDED|||||The P value is from MMRM with treatment, month, and an interaction between treatment and month as fixed effect factors, and baseline MBL volume as a covariate comparing each elagolix treatment group with placebo.|mixed model repeated measures|||||||< 0.001
72581931|NCT02654054|144694456|SUPERIORITY||LS Mean of Difference|-116.2|STANDARD_ERROR_OF_MEAN|19.7|<|0.001|TWO_SIDED|||||The P value is from MMRM with treatment, month, and an interaction between treatment and month as fixed effect factors, and baseline MBL volume as a covariate comparing each elagolix treatment group with placebo.|mixed model repeated measures|||||||< 0.001
72581932|NCT04199104|144694458|SUPERIORITY||point estimate|19.3||||1.9e-06|TWO_SIDED|95.0|11.2|27.3|||Miettinen and Nurminen method|||||27.3|11.2|0.0000019
72581933|NCT04199104|144694459|SUPERIORITY||Hazard Ratio (HR)|0.68||||0.0001129|TWO_SIDED|95.0|0.55|0.83|||Regression, Cox|||||0.83|0.55|0.0001129
72548240|NCT01984242|144625538|SUPERIORITY||Hazard Ratio (HR)|1.3||||0.2867|TWO_SIDED|95.0|0.8|2.13|||Log Rank|||||2.13|0.80|0.2867
72548241|NCT01984242|144625538|SUPERIORITY||Hazard Ratio (HR)|1.06||||0.8039||95.0|0.65|1.73|||Log Rank|||||1.73|0.65|0.8039
72548242|NCT01984242|144625540|SUPERIORITY||Hazard Ratio (HR)|0.91||||0.7879|TWO_SIDED|95.0|0.47|1.78|||Log Rank|||||1.78|0.47|0.7879
72548243|NCT01984242|144625540|SUPERIORITY||Hazard Ratio (HR)|0.96||||0.9065|TWO_SIDED|95.0|0.52|1.8|||Log Rank|||||1.80|0.52|0.9065
72548244|NCT04543136|144625555|SUPERIORITY||Mean Difference (Final Values)|45.0||||0.074|TWO_SIDED|95.0|-4.5|94.5||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||94.5|-4.5|0.074
72548245|NCT04543136|144625555|SUPERIORITY||Mean Difference (Final Values)|58.8||||0.022|TWO_SIDED|95.0|8.5|109.1||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||109.1|8.5|0.022
72581934|NCT04199104|144694460|SUPERIORITY||Hazard Ratio (HR)|1.15||||0.8819584|TWO_SIDED|95.0|0.91|1.45|||Regression, Cox|||||1.45|0.91|0.8819584
72548246|NCT04543136|144625555|SUPERIORITY||Mean Difference (Final Values)|-13.8||||0.587|TWO_SIDED|95.0|-64.2|36.6||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||36.6|-64.2|0.587
72548247|NCT04543136|144625556|SUPERIORITY||Mean Difference (Final Values)|54.9||||0.03|TWO_SIDED|95.0|5.3|104.4||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||104.4|5.3|0.030
72548248|NCT04543136|144625556|SUPERIORITY||Mean Difference (Final Values)|61.8||||0.015|TWO_SIDED|95.0|12.5|111.2||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||111.2|12.5|0.015
72548249|NCT04543136|144625556|SUPERIORITY||Mean Difference (Final Values)|-6.9||||0.78|TWO_SIDED|95.0|-56.5|42.5||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||42.5|-56.5|0.780
72548250|NCT04543136|144625557|SUPERIORITY||Mean Difference (Final Values)|-13.3||||0.281|TWO_SIDED|95.0|-37.9|11.2||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||11.2|-37.9|0.281
72548251|NCT04543136|144625557|SUPERIORITY||Mean Difference (Final Values)|6.6||||0.597|TWO_SIDED|95.0|-18.3|31.7||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||31.7|-18.3|0.597
72548252|NCT04543136|144625557|SUPERIORITY||Mean Difference (Final Values)|-20.0||||0.116|TWO_SIDED|95.0|-45.1|5.0||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||5.0|-45.1|0.116
72548253|NCT04543136|144625558|SUPERIORITY||Mean Difference (Final Values)|3.3||||0.787|TWO_SIDED|95.0|-21.2|27.9||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||27.9|-21.2|0.787
72548254|NCT04543136|144625558|SUPERIORITY||Mean Difference (Final Values)|6.8||||0.576|TWO_SIDED|95.0|-17.6|31.3||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||31.3|-17.6|0.576
72581935|NCT05120193|144694464|NON_INFERIORITY|The primary safety analysis is performed at a one-sided Type I error rate of α = 0.05. The Farrington-Manning method is used to calculate the upper 95% confidence bound for the difference (QI - QC) between the rate of the primary safety endpoint in the investigational arm (QI) and the rate of the primary safety endpoint in the control arm (QC). If the upper confidence bound is less than 0.08, the study is considered to have demonstrated safety of the investigational device.|Risk Difference (RD)|0.005|||<|0.0001|TWO_SIDED|90.0|-0.028|0.037|||Farrington-Manning|||"The null hypothesis (H0) for the primary safety analysis is that the true rate of primary safety events for the investigational device (QI) is equal to or greater than the true rate for the control device (QC) plus a non-inferiority margin (NIM) of 0.08. The alternative hypothesis (HA) is that the rate of primary safety events for the investigational arm (QI) is less than the rate of primary safety events for the control arm (QC) plus the NIM of 0.08.~H0: QI ≥ QC + 0.08 HA: QI \< QC + 0.08"||0.037|-0.028|<0.0001
72548255|NCT04543136|144625558|SUPERIORITY||Mean Difference (Final Values)|-3.5||||0.775|TWO_SIDED|95.0|-28.1|21.0||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||21.0|-28.1|0.775
72548256|NCT04543136|144625559|SUPERIORITY||Mean Difference (Final Values)|-0.09||||0.766|TWO_SIDED|95.0|-0.7|0.52||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.52|-0.70|0.766
72412354|NCT04369469|144332697|OTHER||Risk Difference (RD)|-0.0205||||0.6059|TWO_SIDED|95.0|-0.1703|0.1293||One-sided Mantel-Haenszel test of the difference in two proportions stratified by intubated or not intubated on Day 1 and a family-wise Type I error of 0.025.|Mantel Haenszel||Two-sided 95% confidence interval using the Sato variance estimator, combined overall imputations.|||0.1293|-0.1703|0.6059
72548257|NCT04543136|144625559|SUPERIORITY||Mean Difference (Final Values)|-0.68||||0.032|TWO_SIDED|95.0|-1.3|-0.06||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||-0.06|-1.30|0.032
72548258|NCT04543136|144625559|SUPERIORITY||Mean Difference (Final Values)|0.59||||0.063|TWO_SIDED|95.0|-0.03|1.21||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||1.21|-0.03|0.063
72581936|NCT05120193|144694465|NON_INFERIORITY|The primary effectiveness analysis (PSE) is performed at a one-sided Type I error rate of α = 0.025. The Farrington-Manning method is used to calculate the lower 97.5% confidence bound for the difference (PI - PC) between the rate of the PSE in the investigational arm (PI) and the rate of the PSE in the control arm (PC). If the lower confidence bound is greater than -0.15, the study is considered to have demonstrated effectiveness of the investigational device.|Risk Difference (RD)|0.08||||0.025|TWO_SIDED|95.0|-0.009|0.168|||Farrington-Manning|||"The null hypothesis (H0) is that the true rate of primary effectiveness endpoint success (no failures through Day 360) for the investigational device (PI) is less than or equal to the true rate for the control device (PC) minus the NIM of 0.15. The alternative hypothesis (HA) is that the success rate for the investigational arm (PI) is greater than the success rate for the control device (PC) minus the NIM of 0.15.~H0: PI ≤ PC - 0.15 HA: PI \> PC - 0.15"||0.168|-0.009|0.025
72412355|NCT01802411|144332715|SUPERIORITY||LSMD|13.1||||0.5598|TWO_SIDED|95.0|-31.0|57.0|||ANCOVA|||||57|-31|0.5598
72548259|NCT04543136|144625560|SUPERIORITY||Mean Difference (Final Values)|0.21||||0.213|TWO_SIDED|95.0|-0.12|0.54||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.54|-0.12|0.213
72548260|NCT04543136|144625560|SUPERIORITY||Mean Difference (Final Values)|0.18||||0.291|TWO_SIDED|95.0|-0.16|0.51||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.51|-0.16|0.291
72548261|NCT04543136|144625560|SUPERIORITY||Mean Difference (Final Values)|0.03||||0.868|TWO_SIDED|95.0|-0.31|0.36||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.36|-0.31|0.868
72548262|NCT04543136|144625561|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.661|TWO_SIDED|95.0|-0.35|0.55||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.55|-0.35|0.661
72548263|NCT04543136|144625561|SUPERIORITY||Mean Difference (Final Values)|-0.29||||0.218|TWO_SIDED|95.0|-0.75|0.17||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.17|-0.75|0.218
72548264|NCT04543136|144625561|SUPERIORITY||Mean Difference (Final Values)|0.39||||0.1|TWO_SIDED|95.0|-0.08|0.85||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.85|-0.08|0.100
72548265|NCT04543136|144625562|SUPERIORITY||Mean Difference (Final Values)|-0.13||||0.701|TWO_SIDED|95.0|-0.8|0.54||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.54|-0.80|0.701
72548266|NCT04543136|144625562|SUPERIORITY||Mean Difference (Final Values)|-0.27||||0.438|TWO_SIDED|95.0|-0.96|0.42||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.42|-0.96|0.438
72548267|NCT04543136|144625562|SUPERIORITY||Mean Difference (Final Values)|0.14||||0.689|TWO_SIDED|95.0|-0.55|0.83||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.83|-0.55|0.689
72581937|NCT05120193|144694466|SUPERIORITY||Mean Difference (Final Values)|-29.2|||<|0.0001|TWO_SIDED|95.0|-31.7|-26.8|||t-test, 1 sided|||"The null hypothesis (H0) is that the mean total energy application time during the ablation procedure for the investigational device (ETI) is greater than or equal to the mean time for the control device (ETC). The alternative hypothesis (HA) is that the mean total energy application time for the investigational device is less.~H0: ETI ≥ ETC versus HA: ETI \< ETC"||-26.8|-31.7|<0.0001
72581938|NCT05120193|144694467|SUPERIORITY||Mean Difference (Final Values)|-26.8|||<|0.0001|TWO_SIDED|95.0|-32.2|-21.4|||t-test, 1 sided|||"The null hypothesis (H0) is that the mean treatment time for the investigational device (TTI) is greater than or equal to the mean treatment time for the control device (TTC). The alternative hypothesis (HA) is that the mean treatment time for the investigational device is less.~H0: TTI ≥ TTC versus HA: TTI \< TTC"||-21.4|-32.2|<0.0001
72548268|NCT04543136|144625563|SUPERIORITY||Mean Difference (Final Values)|-0.31||||0.309|TWO_SIDED|95.0|-0.92|0.3||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.30|-0.92|0.309
72548269|NCT04543136|144625563|SUPERIORITY||Mean Difference (Final Values)|-0.49||||0.109|TWO_SIDED|95.0|-1.1|0.11||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.11|-1.10|0.109
72581939|NCT05120193|144694468|SUPERIORITY||Mean Difference (Final Values)|-25.1||||0.025|TWO_SIDED|95.0|-33.0|-17.3|||t-test, 1 sided|||"The null hypothesis (H0) is that the mean procedure time for the investigational device (PTI) is greater than or equal to the mean procedure time for the control device (PTC). The alternative hypothesis (HA) is that the mean procedure time for the investigational device is less.~H0: PTI ≥ PTC versus HA: PTI \< PTC"||-17.3|-33.0|0.025
72581940|NCT05411991|144694525|SUPERIORITY||Net treatment benefit|10.5||||0.357|TWO_SIDED|95.0|-11.9|31.9|||General pairwaise comparison|||||31.9|-11.9|0.357
72581941|NCT02059512|144694539|SUPERIORITY|||||||0.24|||||||Kruskal-Wallis|||||||0.24
72581942|NCT02059512|144694540|SUPERIORITY|||||||0.1|||||||Kruskal-Wallis|||Length of hospital stay.||||0.1
72581943|NCT02059512|144694540|SUPERIORITY|||||||0.1|||||||Kruskal-Wallis|||Length of stay in the intensive care unit.||||0.1
72581944|NCT02059512|144694541|SUPERIORITY|||||||0.4|||||||Kruskal-Wallis|||||||0.4
72581945|NCT02059512|144694541|SUPERIORITY|||||||0.8|||||||Kruskal-Wallis|||Analysis of leukocytes 0-6 hours of the postoperative period.||||0.8
72581946|NCT02059512|144694541|SUPERIORITY|||||||0.9|||||||Kruskal-Wallis|||Analysis of leukocytes 12-18 hours of the postoperative period.||||0.9
72581947|NCT02059512|144694541|SUPERIORITY|||||||0.2|||||||Kruskal-Wallis|||Analysis of leukocytes 18-24 hours of the postoperative period.||||0.2
72412356|NCT03119766|144332744|SUPERIORITY||Mean Difference (Final Values)|0.94||||0.041|TWO_SIDED|95.0|0.04|1.85|||ANOVA||Results are presented as estimated differences of Least Squares Means according to ANOVA model|Mean changes of GIS scores after 8 weeks of treatment were compared.||1.85|0.04|0.041
72581948|NCT02059512|144694541|SUPERIORITY|||||||0.5|||||||Kruskal-Wallis|||Analysis of leukocytes 48 hours of the postoperative period.||||0.5
72581949|NCT02059512|144694541|SUPERIORITY|||||||0.4|||||||Kruskal-Wallis|||Analysis of leukocytes 72 hours of the postoperative period.||||0.4
72581950|NCT02059512|144694541|SUPERIORITY|||||||0.6|||||||Kruskal-Wallis|||Analysis of leukocytes 96 hours of the postoperative period/||||0.6
72581951|NCT02059512|144694541|SUPERIORITY|||||||0.4|||||||Kruskal-Wallis|||Analysis of leukocytes 7 days of the postoperative period.||||0.4
72581952|NCT02059512|144694541|SUPERIORITY|||||||0.5|||||||Kruskal-Wallis|||Analysis of leukocytes 14 days of the postoperative period.||||0.5
72581953|NCT02059512|144694542|SUPERIORITY|||||||0.1|||||||Kruskal-Wallis|||CRP initially.||||0.1
72581954|NCT02059512|144694542|SUPERIORITY|||||||0.4|||||||Kruskal-Wallis|||CRP postoperative 4-6 days.||||0.4
72581955|NCT02059512|144694542|SUPERIORITY|||||||0.99|||||||Kruskal-Wallis|||CRP postoperative 12-14 days.||||0.99
72581956|NCT02059512|144694543|SUPERIORITY|||||||0.2|||||||Kruskal-Wallis|||The volume of discharge through the drains on the first day after surgery.||||0.2
72581957|NCT02059512|144694543|SUPERIORITY|||||||0.3|||||||RepeatedMeasures ANOVA|||The volume of discharge through the drains on the second day after the operation.||||0.3
72548270|NCT04543136|144625563|SUPERIORITY||Mean Difference (Final Values)|0.18||||0.555|TWO_SIDED|95.0|-0.43|0.79||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.79|-0.43|0.555
72548271|NCT04543136|144625564|SUPERIORITY||Mean Difference (Final Values)|-0.02||||0.896|TWO_SIDED|95.0|-0.35|0.31||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.31|-0.35|0.896
72581958|NCT02059512|144694544|SUPERIORITY|||||||0.6|||||||Kruskal-Wallis|||Troponin I postoperative day 1.||||0.6
72581959|NCT02059512|144694544|SUPERIORITY|||||||0.4|||||||Kruskal-Wallis|||Troponin I postoperative day 3.||||0.4
72581960|NCT02059512|144694544|SUPERIORITY|||||||0.8|||||||Kruskal-Wallis|||Myoglobin postoperative day 1.||||0.8
72581961|NCT02059512|144694544|SUPERIORITY|||||||0.7|||||||Kruskal-Wallis|||Myoglobin postoperative day 3.||||0.7
72581962|NCT02059512|144694545|SUPERIORITY|||||||0.7|||||||Kruskal-Wallis|||CPK-MB postoperative day 1.||||0.7
72581963|NCT02059512|144694545|SUPERIORITY|||||||0.8|||||||Kruskal-Wallis|||CPK-MB postoperative day 3.||||0.8
72581964|NCT02059512|144694546|SUPERIORITY|||||||1|||||||Kruskal-Wallis|||Hb intraoperatively before turning off the cardiopulmonary bypass(CPB).||||1.0
72581965|NCT02059512|144694546|SUPERIORITY|||||||0.4|||||||Kruskal-Wallis|||Hb at the end of the operation.||||0.4
72581966|NCT02059512|144694547|SUPERIORITY|||||||0.8|||||||Kruskal-Wallis|||HCT intraoperatively before turning off the cardiopulmonary bypass (CPB).||||0.8
72581967|NCT02059512|144694547|SUPERIORITY|||||||0.3|||||||Kruskal-Wallis|||HCT at the end of the operation.||||0.3
72581968|NCT02059512|144694548|SUPERIORITY|||||||0.4|||||||Kruskal-Wallis|||K+ intraoperatively before turning off the cardiopulmonary bypass (CPB).||||0.4
72581969|NCT02059512|144694548|SUPERIORITY|||||||0.1|||||||Kruskal-Wallis|||K+ at the end of the operation.||||0.1
72581970|NCT02059512|144694549|SUPERIORITY|||||||0.1|||||||Kruskal-Wallis|||||||0.1
72581971|NCT02059512|144694550|SUPERIORITY|||||||0.1|||||||Kruskal-Wallis|||||||0.1
72581972|NCT02059512|144694551|SUPERIORITY|||||||0.6|||||||Chi-squared|||Hydrothorax / postoperative period.||||0.6
72581973|NCT02059512|144694551|SUPERIORITY|||||||0.2|||||||Chi-squared|||Hydropericardium / postoperative period.||||0.2
72581974|NCT02059512|144694551|SUPERIORITY|||||||0.6|||||||Chi-squared|||Resternotomy / postoperative period.||||0.6
72581975|NCT02059512|144694551|SUPERIORITY|||||||0.06|||||||Chi-squared|||Atrial fibrillation / postoperative period.||||0.06
72581976|NCT02059512|144694551|SUPERIORITY|||||||0.06|||||||Chi-squared|||Atrial flutter / postoperative period.||||0.06
72581977|NCT02059512|144694552|SUPERIORITY|||||||0.4|||||||RepeatedMeasures ANOVA|||||||0.4
72581978|NCT02059512|144694553|SUPERIORITY|||||||0.5|||||||RepeatedMeasures ANOVA|||Lvd ind. (Lvd mm./BSA kg / cm) - Evaluation of the left ventricular end-diastolic size index.||||0.5
72581979|NCT02059512|144694553|SUPERIORITY|||||||0.5|||||||RepeatedMeasures ANOVA|||Lvs ind. (Lvs mm./BSA kg / cm) - Evaluation of the left ventricular end-systolic size index.||||0.5
72581980|NCT02059512|144694553|SUPERIORITY|||||||0.6|||||||RepeatedMeasures ANOVA|||LAind. (LA mm./BSA kg / cm) - Left Atrial Size Index Assessment.||||0.6
72581981|NCT02059512|144694554|SUPERIORITY|||||||0.4|||||||RepeatedMeasures ANOVA|||LVEDV MOD BP ind. (LVEDV MOD BP ml./BSA kg / cm) - Evaluation of the left ventricular end-diastolic volume index.||||0.4
72581982|NCT02059512|144694554|SUPERIORITY|||||||0.3|||||||RepeatedMeasures ANOVA|||Evaluation of the left ventricular end-systolic volume index (LVESV MOD BP ind.)||||0.3
72581983|NCT02059512|144694555|SUPERIORITY|||||||0.6|||||||Chi-squared|||||||0.6
72581984|NCT02059512|144694557|SUPERIORITY|||||||0.7|||||||RepeatedMeasures ANOVA|||Physical Functioning SF-36. Comparison of patients of group 1 and group 2 with the control group - group 0.||||0.7
72581985|NCT02059512|144694557|SUPERIORITY|||||||0.8|||||||RepeatedMeasures ANOVA|||Role-Physical Functioning SF-36||||0.8
72581986|NCT02059512|144694557|SUPERIORITY|||||||0.7|||||||RepeatedMeasures ANOVA|||Bodily pain SF-36||||0.7
72581987|NCT02059512|144694557|SUPERIORITY|||||||0.6|||||||RepeatedMeasures ANOVA|||General Health SF-36.||||0.6
72581988|NCT02059512|144694557|SUPERIORITY|||||||0.8|||||||RepeatedMeasures ANOVA|||Vitality SF-36.||||0.8
72581989|NCT02059512|144694557|SUPERIORITY|||||||0.7|||||||RepeatedMeasures ANOVA|||Social Functioning SF-36.||||0.7
72581990|NCT02059512|144694557|SUPERIORITY|||||||0.7|||||||RepeatedMeasures ANOVA|||Role- Emotional SF-36.||||0.7
72581991|NCT02059512|144694557|SUPERIORITY|||||||0.96|||||||RepeatedMeasures ANOVA|||Mental Health SF-36.||||0.96
72581992|NCT02059512|144694557|SUPERIORITY|||||||0.7|||||||RepeatedMeasures ANOVA|||Minnesota Quality of Life (MHFLQ).||||0.7
72548272|NCT04543136|144625564|SUPERIORITY||Mean Difference (Final Values)|-0.16||||0.32|TWO_SIDED|95.0|-0.49|0.16||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.16|-0.49|0.320
72548273|NCT04543136|144625564|SUPERIORITY||Mean Difference (Final Values)|0.14||||0.39|TWO_SIDED|95.0|-0.19|0.47||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.47|-0.19|0.390
72548274|NCT04543136|144625565|SUPERIORITY||Mean Difference (Final Values)|-0.06||||0.802|TWO_SIDED|95.0|-0.51|0.4||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.40|-0.51|0.802
72548275|NCT04543136|144625565|SUPERIORITY||Mean Difference (Final Values)|-0.4||||0.082|TWO_SIDED|95.0|-0.85|0.05||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.05|-0.85|0.082
72548276|NCT04543136|144625565|SUPERIORITY||Mean Difference (Final Values)|0.34||||0.137|TWO_SIDED|95.0|-0.11|0.8||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.80|-0.11|0.137
72548277|NCT04543136|144625566|SUPERIORITY||Mean Difference (Final Values)|-0.22||||0.525|TWO_SIDED|95.0|-0.89|0.46||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.46|-0.89|0.525
72548278|NCT04543136|144625566|SUPERIORITY||Mean Difference (Final Values)|-0.56||||0.098|TWO_SIDED|95.0|-1.24|0.11||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.11|-1.24|0.098
72581993|NCT02059512|144694557|SUPERIORITY|||||||0.6|||||||RepeatedMeasures ANOVA|||Seattle QuestionnairePhysical limitation.||||0.6
72581994|NCT02059512|144694557|SUPERIORITY|||||||0.4|||||||RepeatedMeasures ANOVA|||SeattleQuestionnaireAngina stability.||||0.4
72548279|NCT04543136|144625566|SUPERIORITY||Mean Difference (Final Values)|0.35||||0.306|TWO_SIDED|95.0|-0.33|1.02||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||1.02|-0.33|0.306
72548280|NCT01626079|144625567|NON_INFERIORITY|Two thousand (2000) simulations were performed to calculate sample size and power for the primary safety endpoint. Assuming 22% mortality and 7.5% attrition at 12 months, a total of 305 subjects in the Device group will provide \> 95% power to reject the null hypothesis at the one-sided significance level of 5%.|Kaplan Meier|0.966|STANDARD_ERROR_OF_MEAN|0.011|<|0.0001|ONE_SIDED|95.0|0.948||||Z test Using Kaplan Meier Survival|P-value calculated from Z test using Kaplan Meier survival estimate together with Greenwood method estimated variance|||||0.948|<0.0001
72581995|NCT02059512|144694557|SUPERIORITY|||||||0.6|||||||RepeatedMeasures ANOVA|||SeattleQuestionnaireAngina frequency.||||0.6
72581996|NCT02059512|144694557|SUPERIORITY|||||||0.7|||||||RepeatedMeasures ANOVA|||SeattleQuestionnaireTreatment satisfaction.||||0.7
72581997|NCT02059512|144694557|SUPERIORITY|||||||0.3|||||||RepeatedMeasures ANOVA|||SeattleQuestionnaire Disease perception.||||0.3
72581998|NCT02059512|144694558|SUPERIORITY|||||||0.001|||||||Chi-squared|||||||0.001
72581999|NCT02059512|144694559|SUPERIORITY|||||||0.13|||||||Chi-squared|||||||0.13
72582000|NCT02059512|144694560|SUPERIORITY|||||||0.35|||||||RepeatedMeasures ANOVA|||||||0.35
72582001|NCT02059512|144694561|SUPERIORITY|||||||0.2|||||||RepeatedMeasures ANOVA|||Lvd ind. (Lvd mm./BSA) - left ventricular end-diastolic size index. All patients included in the study.||||0.2
72582002|NCT02059512|144694561|SUPERIORITY|||||||0.2|||||||RepeatedMeasures ANOVA|||Lvs ind. (Lvs mm./BSA kg / cm) - left ventricular end-systolic size index.||||0.2
72582003|NCT02059512|144694561|SUPERIORITY|||||||0.5|||||||RepeatedMeasures ANOVA|||LAind. (LA mm./BSA kg / cm) - left atrial index.||||0.5
72582004|NCT02059512|144694562|SUPERIORITY|||||||0.6|||||||RepeatedMeasures ANOVA|||LVEDV MOD BP ind. (LVEDV MOD BP ml./BSA kg / cm) - left ventricular end-diastolic volume index.||||0.6
72582005|NCT02059512|144694562|SUPERIORITY|||||||0.2|||||||RepeatedMeasures ANOVA|||LVESV MOD BP ind. (LVESV MOD BP ml./BSA kg / cm) - left ventricular end-systolic volume index.||||0.2
72582006|NCT02059512|144694563|SUPERIORITY|||||||0.35|||||||RepeatedMeasures ANOVA|||Peak E of transmitral flow||||0.35
72582007|NCT02059512|144694563|SUPERIORITY|||||||0.7|||||||RepeatedMeasures ANOVA|||Peak A of transmitral flow.||||0.7
72582008|NCT02059512|144694564|SUPERIORITY|||||||0.5|||||||RepeatedMeasures ANOVA|||Peak E of transmitral flow/ Peak A of transmitral flow (E/A).||||0.5
72582009|NCT02059512|144694565|SUPERIORITY|||||||0.9|||||||RepeatedMeasures ANOVA|||DT (Half-time of wave E).||||0.9
72582010|NCT02059512|144694565|SUPERIORITY|||||||0.9|||||||RepeatedMeasures ANOVA|||time of isovolumic relaxation of the left ventricle||||0.9
72582011|NCT02059512|144694566|SUPERIORITY|||||||0.0367|||||||Kruskal-Wallis|||||||0.0367
72582012|NCT02059512|144694567|SUPERIORITY|||||||0.04|||||||Chi-squared|||Assessment of the functioning of grafts. Patency of grafts within a specified time of treatment (angiography).||||0.04
72582013|NCT02059512|144694568|SUPERIORITY|||||||0.05|||||||Chi-squared|||||||0.05
72582014|NCT02059512|144694569|SUPERIORITY|||||||0.05|||||||Discriminant Analysis|||||||0.05
72548281|NCT01626079|144625600|SUPERIORITY||Hazard Ratio (HR)|0.76|||<|0.02|TWO_SIDED|95.0|0.6|0.96|||Joint Fraility Model|||||0.96|0.60|<0.02
72582015|NCT02059512|144694570|SUPERIORITY|||||||0.05|||||||Discriminant Analysis|Data were analyzed by 1, 2, and 3 sections according to the study design.||Mononuclear fraction %||||0.05
72548282|NCT01626079|144625601|SUPERIORITY||Win Ratio|1.61|||<|0.0001|TWO_SIDED|95.0|1.29|2.04|||Finkelstein-Schoenfeld Analysis|||||2.04|1.29|<0.0001
72548283|NCT00865709|144625905|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.884||||0.2309|TWO_SIDED|95.0|0.635|1.231||1-sided p-value from stratified log-rank test, stratified by factors of # metastatic sites and liver metastasis determined by Principal Investigator|Log Rank||The relative risk (sorafenib to placebo) was estimated by the hazard ratio from stratified Cox regression with a 95% confidence interval.|A sample size of 120 PFS events would provide a \> 85% power at a target HR = 0.65 between sorafenib and matching placebo, with a 1-sided alpha = 0.10, for testing the null hypothesis H0: HR ≥ 1 versus the alternative hypothesis H1: HR \< 1 based on the log-rank test. The test was conducted using the intent-to-treat (ITT) population, defined as all subjects who were randomized to treatment.||1.231|0.635|0.2309
72548284|NCT00865709|144625907|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.829||||0.1437|TWO_SIDED|95.0|0.586|1.174||1-sided p-value from stratified log-rank test, stratified by factors of # metastatic sites and liver metastasis determined by Principal Investigator|Log Rank||The relative risk (sorafenib to placebo) was estimated by the hazard ratio from stratified Cox regression with a 95% confidence interval.|A sample size of 120 PDs would provide a \> 85% power at a target HR = 0.65 between sorafenib and matching placebo, with a 1-sided alpha = 0.10, for testing H0: HR ≥ 1 versus H1: HR \< 1 based on the log-rank test. The test was conducted using the intent-to-treat (ITT) population (all subjects who were randomized).||1.174|0.586|0.1437
72548285|NCT00865709|144625908|SUPERIORITY_OR_OTHER|||||||0.023||95.0||||1-sided p-value from the Cochran-Mantel-Haenszel test, adjusting for the stratification factors of # metastatic sites and liver metastasis determined by Principal Investigator|Cochran-Mantel-Haenszel|||The proportion of subjects achieving overall response (CR or PR), when confirmation of response was not required, was estimated with a 95% confidence interval for each treatment group. The treatment groups were compared with respect to overall response rate using the Cochran-Mantel-Haenszel test, adjusting for the stratification factors.||||0.023
72548286|NCT00429923|144625910|SUPERIORITY_OR_OTHER|||||||0.0014||95.0|||||Mantel Haenszel|||||||0.0014
72548287|NCT01041781|144625914|SUPERIORITY||Hazard Ratio (HR)|1.076||||0.5346|TWO_SIDED|95.0|0.853|1.367|||Log Rank|||||1.367|0.853|0.5346
72548288|NCT01041781|144625918|SUPERIORITY|||||||0.0049|||||||Log Rank|||||||0.0049
72548289|NCT01041781|144625919|SUPERIORITY|||||||0.0131|||||||Log Rank|||||||0.0131
72548290|NCT01041781|144625920|SUPERIORITY|||||||0.0322|||||||Log Rank|||||||0.0322
72548291|NCT00662129|144625935|SUPERIORITY_OR_OTHER|||||||0.003|||||||t-test, 2 sided|||||||0.003
72548292|NCT02799602|144625948|SUPERIORITY|Hazard ratio \< 1 indicates superiority of Darolutamide+docetaxel arm over Placebo+docetaxel arm. Hazard ratio and 95% CI was based on Cox Regression Model, stratified by EOD (Non-regional lymph nodes metastases only vs. Bone metastases with or without lymph node metastases vs. Visceral metastases with or without lymph node metastases or with or without bone metastases) and ALP (\<ULN vs. \>=ULN).|Hazard Ratio (HR)|0.675|||<|0.0001|TWO_SIDED|95.0|0.568|0.801||One-sided p-value.|Log Rank||||One-sided p-value from log-rank test, stratified by EOD (Non-regional lymph nodes metastases only vs. Bone metastases with or without lymph node metastases vs. Visceral metastases with or without lymph node metastases or with or without bone metastases) and ALP (\<ULN vs. \>=ULN).|0.801|0.568|<0.0001
72548293|NCT02799602|144625951|SUPERIORITY|Hazard ratio \< 1 indicates superiority of Darolutamide+docetaxel arm over Placebo+docetaxel arm. Hazard ratio and 95% CI was based on Cox Regression Model, stratified by EOD (Non-regional lymph nodes metastases only vs. Bone metastases with or without lymph node metastases vs. Visceral metastases with or without lymph node metastases or with or without bone metastases) and ALP (\<ULN vs. \>=ULN).|Hazard Ratio (HR)|0.357|||<|0.0001|TWO_SIDED|95.0|0.302|0.421||One-sided p-value.|Log Rank||||One-sided p-value from log-rank test, stratified by EOD (Non-regional lymph nodes metastases only vs. Bone metastases with or without lymph node metastases vs. Visceral metastases with or without lymph node metastases or with or without bone metastases) and ALP (\<ULN vs. \>=ULN).|0.421|0.302|<0.0001
72548294|NCT02799602|144625953|SUPERIORITY|Hazard ratio \< 1 indicates superiority of Darolutamide+docetaxel arm over Placebo+docetaxel arm. Hazard ratio and 95% CI was based on Cox Regression Model, stratified by EOD (Non-regional lymph nodes metastases only vs. Bone metastases with or without lymph node metastases vs. Visceral metastases with or without lymph node metastases or with or without bone metastases) and ALP (\<ULN vs. \>=ULN).|Hazard Ratio (HR)|0.792||||0.0058|TWO_SIDED|95.0|0.66|0.95||One-sided p-value.|Log Rank||||One-sided p-value from log-rank test, stratified by EOD (Non-regional lymph nodes metastases only vs. Bone metastases with or without lymph node metastases vs. Visceral metastases with or without lymph node metastases or with or without bone metastases) and ALP (\<ULN vs. \>=ULN).|0.950|0.660|0.0058
72548295|NCT02799602|144625955|SUPERIORITY|Hazard ratio \< 1 indicates superiority of Darolutamide+docetaxel arm over Placebo+docetaxel arm. Hazard ratio and 95% CI was based on Cox Regression Model, stratified by EOD (Non-regional lymph nodes metastases only vs. Bone metastases with or without lymph node metastases vs. Visceral metastases with or without lymph node metastases or with or without bone metastases) and ALP (\<ULN vs. \>=ULN).|Hazard Ratio (HR)|0.609|||<|0.0001|TWO_SIDED|95.0|0.516|0.718||One-sided p-value.|Log Rank||||One-sided p-value from log-rank test, stratified by EOD (Non-regional lymph nodes metastases only vs. Bone metastases with or without lymph node metastases vs. Visceral metastases with or without lymph node metastases or with or without bone metastases) and ALP (\<ULN vs. \>=ULN).|0.718|0.516|<0.0001
72548296|NCT02799602|144625957|SUPERIORITY|Hazard ratio \< 1 indicates superiority of Darolutamide+docetaxel arm over Placebo+docetaxel arm. Hazard ratio and 95% CI was based on Cox Regression Model, stratified by EOD (Non-regional lymph nodes metastases only vs. Bone metastases with or without lymph node metastases vs. Visceral metastases with or without lymph node metastases or with or without bone metastases) and ALP (\<ULN vs. \>=ULN).|Hazard Ratio (HR)|0.712||||0.0081|TWO_SIDED|95.0|0.539|0.94||One-sided p-value.|Log Rank||||One-sided p-value from log-rank test, stratified by EOD (Non-regional lymph nodes metastases only vs. Bone metastases with or without lymph node metastases vs. Visceral metastases with or without lymph node metastases or with or without bone metastases) and ALP (\<ULN vs. \>=ULN).|0.940|0.539|0.0081
72548297|NCT02799602|144625959|SUPERIORITY|Hazard ratio \< 1 indicates superiority of Darolutamide+docetaxel arm over Placebo+docetaxel arm. Hazard ratio and 95% CI was based on Cox Regression Model, stratified by EOD (Non-regional lymph nodes metastases only vs. Bone metastases with or without lymph node metastases vs. Visceral metastases with or without lymph node metastases or with or without bone metastases) and ALP (\<ULN vs. \>=ULN).|Hazard Ratio, log|0.388|||<|0.0001|TWO_SIDED|95.0|0.328|0.458||One-sided p-value.|Log Rank||||One-sided p-value from log-rank test, stratified by EOD (Non-regional lymph nodes metastases only vs. Bone metastases with or without lymph node metastases vs. Visceral metastases with or without lymph node metastases or with or without bone metastases) and ALP (\<ULN vs. \>=ULN).|0.458|0.328|<0.0001
72548298|NCT02799602|144625961|SUPERIORITY|Hazard ratio \< 1 indicates superiority of Darolutamide+docetaxel arm over Placebo+docetaxel arm. Hazard ratio and 95% CI was based on Cox Regression Model, stratified by EOD (Non-regional lymph nodes metastases only vs. Bone metastases with or without lymph node metastases vs. Visceral metastases with or without lymph node metastases or with or without bone metastases) and ALP (\<ULN vs. \>=ULN).|Hazard Ratio (HR)|1.043||||0.7073|TWO_SIDED|95.0|0.894|1.217||One-sided p-value.|Log Rank||||One-sided p-value from log-rank test, stratified by EOD (Non-regional lymph nodes metastases only vs. Bone metastases with or without lymph node metastases vs. Visceral metastases with or without lymph node metastases or with or without bone metastases) and ALP (\<ULN vs. \>=ULN).|1.217|0.894|0.7073
72548299|NCT02799602|144625963|SUPERIORITY|Hazard ratio \< 1 indicates superiority of Darolutamide+docetaxel arm over Placebo+docetaxel arm. Hazard ratio and 95% CI was based on Cox Regression Model, stratified by EOD (Non-regional lymph nodes metastases only vs. Bone metastases with or without lymph node metastases vs. Visceral metastases with or without lymph node metastases or with or without bone metastases) and ALP (\<ULN vs. \>=ULN).|Hazard Ratio (HR)|0.688||||0.0037|TWO_SIDED|95.0|0.523|0.906||One-sided p-value.|Log Rank||||One-sided p-value from log-rank test, stratified by EOD (Non-regional lymph nodes metastases only vs. Bone metastases with or without lymph node metastases vs. Visceral metastases with or without lymph node metastases or with or without bone metastases) and ALP (\<ULN vs. \>=ULN).|0.906|0.523|0.0037
72548300|NCT02099461|144625973|SUPERIORITY_OR_OTHER||LS Mean|0.15||||0.2966|TWO_SIDED|95.0|-0.136|0.441|||ANCOVA|||An ANCOVA analysis was performed on the log ratio of post-baseline to baseline Ki-67 index. Independent variables included treatment, stratification factor, and log transformed baseline Ki-67 index.||0.441|-0.136|0.2966
72548301|NCT02099461|144625973|SUPERIORITY_OR_OTHER||LS Mean|-0.16||||0.2769|TWO_SIDED|95.0|-0.447|0.13|||ANCOVA|||An ANCOVA analysis was performed on the log ratio of post-baseline to baseline Ki-67 index. Independent variables included treatment, stratification factor, and log transformed baseline Ki-67 index.||0.130|-0.447|0.2769
72548302|NCT02099461|144625973|SUPERIORITY_OR_OTHER||LS Mean|-0.09||||0.5238|TWO_SIDED|95.0|-0.373|0.191|||ANCOVA|||An ANCOVA analysis was performed on the log ratio of post-baseline to baseline Ki-67 index. Independent variables included treatment, stratification factor, and log transformed baseline Ki-67 index.||0.191|-0.373|0.5238
72548303|NCT02099461|144625973|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.31||||0.1343|TWO_SIDED|95.0|-0.72|0.098|||ANCOVA||Denosumab 60 mg - Placebo|An ANCOVA analysis was performed on the log ratio of post-baseline to Baseline Ki-67 index. Independent variables included treatment, stratification factor, and log transformed baseline Ki-67 index.||0.098|-0.720|0.1343
72548304|NCT02099461|144625973|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.24||||0.2345|TWO_SIDED|95.0|-0.646|0.161|||ANCOVA||Denosumab 120 mg - Placebo|An ANCOVA analysis was performed on the log ratio of post-baseline to Baseline Ki-67 index. Independent variables included treatment, stratification factor, and log transformed baseline Ki-67 index.||0.161|-0.646|0.2345
72548305|NCT00720122|144625976|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.00558|STANDARD_ERROR_OF_MEAN|0.00653||0.4|TWO_SIDED|95.0|-0.0081|0.0193|||Paired t-test|||A paired t-test was performed. The null hypothesis was that bone density would decrease over 6 months in females with anorexia nervosa, as observed in life course studies.||0.0193|-0.0081|0.40
72412357|NCT03119766|144332744|SUPERIORITY||Mean Difference (Final Values)|0.89||||0.041|TWO_SIDED|95.0|0.04|1.74|||Mixed Models Analysis||"Fixed factor Treatment and random factor research center were used in mixed model. Difference in mean changes between groups was estimeted."|Mean changes of GIS scores after 8 weeks of treatment were compared. Influence of between center variation was estimated.||1.74|0.04|0.041
72548306|NCT00329602|144625987|SUPERIORITY_OR_OTHER|||||||0.039||95.0||||P-value is for Week 12.|Repeated Measures Mixed Model|Adjusted for baseline IRLS Rating Scale total score, treatment group, visit, visit by treatment group interaction, and center group.||||||0.039
72548307|NCT00329602|144625987|SUPERIORITY_OR_OTHER|||||||0.023||95.0||||P-value is for Week 26.|Repeated Measures Mixed Model|Adjusted for baseline IRLS Rating Scale total score, treatment group, visit, visit by treatment group interaction, and center group.||||||0.023
72548308|NCT02275364|144626002|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|15.28|||<|0.0001|TWO_SIDED|95.0|12.32|18.25||Obtained from ANOVA model with Treatment and Period as fixed effects and subject as a random effect.|ANOVA||Adjusted Mean Difference is the treatment difference defined as the Adjusted Mean of Test Nasal Strip minus Adjusted Mean of Placebo Strip.|||18.25|12.32|<0.0001
72548309|NCT02275364|144626003|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.93||||0.7366|TWO_SIDED|95.0|-6.43|4.57||Obtained from ANOVA with treatment, period and region of interest as fixed effects and subject as a random effect.|ANCOVA||Adjusted Mean Difference is the Treatment difference defined as the Adjusted Mean of Test Nasal Strip minus Adjusted Mean of Placebo Strip.|||4.57|-6.43|0.7366
72582016|NCT02059512|144694570|SUPERIORITY|||||||0.057|||||||Discriminant Analysis|Data were analyzed by 1, 2, and 3 sections according to the study design.||CD34+ %||||0.057
72582017|NCT02059512|144694570|SUPERIORITY|||||||0.05|||||||Discriminant Analysis|||CD133+ %||||0.05
72412358|NCT03119766|144332745|SUPERIORITY|||||||0.067|||||||Fisher Exact|||Test for comparison percentage of patients with reduction ≥ 1 point.||||0.067
72412359|NCT03119766|144332745|SUPERIORITY|||||||0.029|||||||Fisher Exact|||Test for comparison percentage of patients with reduction ≥ 2 points.||||0.029
72548310|NCT02275364|144626004|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|1533.74||||0.0004|TWO_SIDED|95.0|794.16|2273.32||Obtained from ANOVA model with Treatment and Period as fixed effects and subject as a random effect.|ANOVA||Adjusted Mean Difference is the Treatment difference defined as the Adjusted Mean of Test Nasal Strip minus Adjusted Mean of Placebo Strip.|||2273.32|794.16|0.0004
72548311|NCT02275364|144626005|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.46||||0.7278|TWO_SIDED|95.0|-3.06|2.14||Obtained from ANOVA model with Treatment and Period as fixed effects and subject as a random effect.|ANOVA||Adjusted Mean Difference is the Treatment difference defined as the Adjusted Mean of Test Nasal Strip minus Adjusted Mean of Placebo Strip.|||2.14|-3.06|0.7278
72548312|NCT02275364|144626006|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|191.72||||0.1639|TWO_SIDED|95.0|-78.62|462.06||Obtained from ANOVA model with Treatment and Period as fixed effects and subject as a random effect.|ANCOVA||Adjusted Mean Difference is the Treatment difference defined as the Adjusted Mean of Test Nasal Strip minus Adjusted Mean of Placebo Strip.|||462.06|-78.62|0.1639
72548313|NCT02275364|144626007|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.02||||0.4621|TWO_SIDED|95.0|-0.03|0.07||Obtained from ANOVA with treatment, period and region of interest as fixed effects and subject as a random effect.|ANOVA||Adjusted Mean Difference is the Treatment difference defined as the Adjusted Mean of Test Nasal Strip minus Adjusted Mean of Placebo Strip.|||0.07|-0.03|0.4621
72548314|NCT00663871|144626064|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.04||||0.59|TWO_SIDED|95.0|-0.27|0.19|||ANOVA|||||0.19|-0.27|0.59
72582018|NCT02059512|144694571|SUPERIORITY|||||||0.046|||||||Factor analysis|||Factor analysis - determining the influence of a factor, in this case, smoking, on the deficit in the number of meters passed according to the test with a 6-minute walk.||||0.046
72582019|NCT03848715|144694594|SUPERIORITY|||||||0.16|||||||Regression, Linear|||||||.16
72582020|NCT06700512|144694612|SUPERIORITY||||||<|0.001|||||||t-test, 1 sided|paired||"H0 (Objective 1) SRT (study HA) is either not significantly different from SRT without HAs or significantly worse than SRT without HAs.~H1(Objective 1) SRT(study HA) is significantly better than SRT without HAs. A mean difference in SRT of 1 dB measured with the Oldenburg sentence test can be assumed as a typical difference in speech intelligibility to show a clinically meaningful improvement."||||<0.001
72582021|NCT06700512|144694612|NON_INFERIORITY|A mean difference in SRT of 1 dB measured with the Oldenburg sentence test (Wagener et al, 1999a-c), can be assumed as a typical difference in speech intelligibility to show a clinically meaningful improvement (Kollmeier et al, 2011). Thus if SRT with study hearing aids is 1dB or more worse than with subjects' own hearing aids and the difference is significant (p\<0.05), inferiority of study hearing aid is assumed otherwise study hearing aids are considered non-inferior|||||<|0.001||||||paired|t-test, 1 sided|||H0 (Objective 2) SRT (study HA) is significantly worse than SRT(own HAs). H1(Objective 2) There is no difference between SRT(study HA) and SRT(own HAs) or SRT (study HA) is significantly better than SRT (own HAs) SRT= Speech Reception Threshold in dB||||<0.001
72582022|NCT05842967|144694643|NON_INFERIORITY|Noninferiority was declared if both the null hypothesis of GMR and the null hypothesis of difference in seroresponse rates were rejected for both RSV A and RSV B serum NTs, with a type I error (2-sided) of 5%.|GMR|1.57|||||TWO_SIDED|95.0|1.396|1.759|||||GMRs (ratio of GMTs from C3671023 SSA to C3671013 immunogenicity subset), 2-sided CI were calculated by exponentiating difference in LS means, corresponding CIs based on regression model. Data reported here is for RSV A.|||1.759|1.396|
72582023|NCT05842967|144694643|NON_INFERIORITY|Noninferiority was declared if both the null hypothesis of GMR and the null hypothesis of difference in seroresponse rates were rejected for both RSV A and RSV B serum NTs, with a type I error (2-sided) of 5%.|GMR|1.52|||||TWO_SIDED|95.0|1.333|1.725|||||GMRs (ratio of GMTs from C3671023 SSA to C3671013 immunogenicity subset), 2-sided CI were calculated by exponentiating difference in LS means, corresponding CIs based on regression model. Data reported here is for RSV B.|||1.725|1.333|
72582024|NCT05842967|144694644|NON_INFERIORITY|Noninferiority was declared if both the null hypothesis of GMR and the null hypothesis of difference in seroresponse rates were rejected for both RSV A and RSV B serum NTs, with a type I error (2-sided) of 5%.|Difference in percentage|5.1|||||TWO_SIDED|95.0|1.2|9.2|||||Difference (C3671023 SSA, compared to C3671013 immunogenicity subset) in proportions, expressed as a percentage; 95% CIs for percentage difference were calculated using exact method based on Miettinen and Nurminen. Data reported here is for RSV A.|||9.2|1.2|
72582025|NCT05842967|144694644|NON_INFERIORITY|Noninferiority was declared if both the null hypothesis of GMR and the null hypothesis of difference in seroresponse rates were rejected for both RSV A and RSV B serum NTs, with a type I error (2-sided) of 5%.|Difference in percentage|8.3|||||TWO_SIDED|95.0|4.2|12.6|||||Difference (C3671023 SSA, compared to C3671013 immunogenicity subset) in proportions, expressed as a percentage; 95% CIs for percentage difference were calculated using exact method based on Miettinen and Nurminen. Data reported here is for RSV B.|||12.6|4.2|
72582026|NCT06192589|144694680|OTHER|A difference in exposure was concluded if the 2-sided 90% CI of the geometric mean ratio excluded 1, which is standard in pharmacokinetic studies|Geometric mean ratio|1.43|||<|0.01|TWO_SIDED|90.0|1.34|1.52||Analyses are not adjusted for multiplicity.|Mixed Models Analysis||Comparison was the effect of cannabidiol on citalopram compared to citalopram alone.|Area under the curve was log-transformed and the values between groups were compared using a linear mixed effects model with group as a categorical variable and subject as a random effect||1.52|1.34|<0.01
72582027|NCT06192589|144694681|OTHER|A difference in exposure was concluded if the 2-sided 90% CI of the geometric mean ratio excluded 1, which is standard in pharmacokinetic studies|Geometric mean ratio|1.12|||<|0.01|TWO_SIDED|90.0|1.06|1.17||Analyses are not adjusted for multiplicity.|Mixed Models Analysis||Comparison was the effect of cannabidiol on citalopram compared to citalopram alone.|Maximum concentration was log-transformed and the values between groups were compared using a linear mixed effects model with group as a categorical variable and subject as a random effect||1.17|1.06|<0.01
72412360|NCT03119766|144332745|SUPERIORITY|||||||0.082|||||||Fisher Exact|||Test for comparison percentage of patients with reduction ≥ 3 points.||||0.082
72412361|NCT03119766|144332745|SUPERIORITY|||||||0.046|||||||Fisher Exact|||Test for comparison percentage of patients with reduction ≥ 4 points.||||0.046
72412362|NCT03119766|144332745|SUPERIORITY|||||||0.111|||||||Fisher Exact|||Test for comparison percentage of patients with reduction ≥ 5 points.||||0.111
72548315|NCT00663871|144626065|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.05||||0.21|TWO_SIDED|95.0|-0.24|0.19|||ANOVA|||||0.19|-0.24|0.21
72548316|NCT00663871|144626066|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.02||||0.92|TWO_SIDED|95.0|0.69|1.5||The model included effects of treatment (fish oil, placebo), time (baseline, post-intervention), and interaction terms of treatment with time. The Negative Affect scores were categorized by quartiles of the baseline measures.|Mixed Models Analysis|Generalized Linear Mixed Modeling was used with a multinomial distribution with cumulative link.||||1.50|0.69|0.92
72548317|NCT00663871|144626067|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.12||||0.86|TWO_SIDED|95.0|-1.21|1.44||The model included effects of treatment (fish oil, placebo), time (baseline, post-intervention), and interaction terms of treatment with time.|Mixed Models Analysis|||||1.44|-1.21|0.86
72548318|NCT00663871|144626068|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.31||||0.63|TWO_SIDED|95.0|-1.57|0.94||The model included effects of treatment (fish oil, placebo), time (baseline, post-intervention), and interaction terms of treatment with time.|Mixed Models Analysis|||||0.94|-1.57|0.63
72548319|NCT00663871|144626069|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.32||||0.5|TWO_SIDED|95.0|-1.25|0.61||The model included effects of treatment (fish oil, placebo), time (baseline, post-intervention), and interaction terms of treatment with time.|Mixed Models Analysis|||||0.61|-1.25|0.50
72412363|NCT03119766|144332746|SUPERIORITY||Mean Difference (Final Values)|0.61||||0.435|TWO_SIDED|95.0|-0.93|2.15|||ANOVA||Results are presented as estimated differences of Least Squares Means according to ANOVA model|Mean changes of NDI scores after 8 weeks of treatment were compared.||2.15|-0.93|0.435
72412364|NCT03119766|144332747|SUPERIORITY||Mean Difference (Final Values)|-0.37||||0.655|TWO_SIDED|95.0|-2.0|1.26|||ANOVA||Results are presented as estimated differences of Least Squares Means according to ANOVA model|Mean changes of SF-36 scores (physical health domain) after 8 weeks of treatment were compared.||1.26|-2.00|0.655
72412365|NCT03119766|144332747|SUPERIORITY||Median Difference (Final Values)|0.65||||0.375|TWO_SIDED|95.0|-0.79|2.1|||ANOVA|||Mean changes of SF-36 scores (mental health domain) after 8 weeks of treatment were compared.||2.10|-0.79|0.375
72548320|NCT00663871|144626070|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.33||||0.25|TWO_SIDED|95.0|-0.23|0.88||The model included effects of treatment (fish oil, placebo), time (baseline, post-intervention), and interaction terms of treatment with time.|Mixed Models Analysis|||||0.88|-0.23|0.25
72412366|NCT03119766|144332748|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1
72412367|NCT03119766|144332749|SUPERIORITY|||||||0.08|||||||Wilcoxon (Mann-Whitney)|||Side effects analysis.||||0.08
72412368|NCT03119766|144332749|SUPERIORITY|||||||0.139|||||||Wilcoxon (Mann-Whitney)|||Therapeutic effect||||0.139
72412369|NCT03119766|144332749|SUPERIORITY|||||||0.251|||||||Wilcoxon (Mann-Whitney)|||Efficacy index analysis.||||0.251
72412370|NCT02034578|144332752|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|0.953|||||TWO_SIDED|90.0|0.873|1.04||||||B versus A||1.040|0.873|
72412371|NCT02034578|144332752|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|0.805|||||TWO_SIDED|90.0|0.749|0.865||||||C versus A||0.865|0.749|
72548321|NCT00663871|144626071|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.45||||0.52|TWO_SIDED|95.0|-1.83|0.92||The model included effects of treatment (fish oil, placebo), time (baseline, post-intervention), and interaction terms of treatment with time.|Mixed Models Analysis|||||0.92|-1.83|0.52
72548322|NCT00663871|144626072|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.22||||0.52|TWO_SIDED|95.0|0.67|2.24||The model included effects for treatment (fish oil, placebo), time (baseline, post-intervention), and interaction terms of treatment with time. The Type A personality scores were categorized by quartiles of the baseline measures.|Mixed Models Analysis|Generalized Linear Mixed Modeling was used with a multinomial distribution with cumulative link.||||2.24|0.67|0.52
72412372|NCT02034578|144332754|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|0.966|||||TWO_SIDED|90.0|0.924|1.01||||||B versus A||1.010|0.924|
72412373|NCT02034578|144332754|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|0.919|||||TWO_SIDED|90.0|0.896|0.942||||||C versus A||0.942|0.896|
72548323|NCT00663871|144626073|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.03||||0.68|TWO_SIDED|95.0|-0.16|0.1||The model included effects for treatment (fish oil, placebo), time (baseline, post-intervention), and interaction terms of treatment with time.|Mixed Models Analysis|||||0.10|-0.16|0.68
72548324|NCT00663871|144626074|SUPERIORITY_OR_OTHER_LEGACY|The model included effects for treatment (fish oil, placebo), time (baseline, post-intervention), and interaction terms of treatment with time.|Mean Difference (Net)|-0.17||||0.16|TWO_SIDED|95.0|-0.41|0.07|||Mixed Models Analysis|||||0.07|-0.41|0.16
72548325|NCT00663871|144626075|SUPERIORITY_OR_OTHER_LEGACY|The model included effects for treatment (fish oil, placebo), time (baseline, post-intervention), and interaction terms of treatment with time.|Mean Difference (Net)|-0.05||||0.59|TWO_SIDED|95.0|-0.24|0.14|||Mixed Models Analysis|||||0.14|-0.24|0.59
72548326|NCT00663871|144626076|SUPERIORITY_OR_OTHER_LEGACY|The model included effects for treatment (fish oil, placebo), time (baseline, post-intervention), and interaction terms of treatment with time.|Mean Difference (Net)|0.06||||0.35|TWO_SIDED|95.0|-0.06|0.18|||Mixed Models Analysis|||||0.18|-0.06|0.35
72548327|NCT00663871|144626077|SUPERIORITY_OR_OTHER_LEGACY|The model included effects for treatment (fish oil, placebo), time (baseline, post-intervention), and interaction terms of treatment with time.|Mean Difference (Net)|0.04||||0.74|TWO_SIDED|95.0|-0.18|0.25|||Mixed Models Analysis|||||0.25|-0.18|0.74
72548328|NCT00663871|144626078|SUPERIORITY_OR_OTHER_LEGACY|The model included effects for treatment (fish oil, placebo), time (baseline, post-intervention), and interaction terms of treatment with time.|Mean Difference (Net)|-0.1||||0.28|TWO_SIDED|95.0|-0.27|0.08|||Mixed Models Analysis|||||0.08|-0.27|0.28
72548329|NCT00663871|144626079|SUPERIORITY_OR_OTHER_LEGACY||standardized mean difference|0.15||||0.76|TWO_SIDED|95.0|-0.09|0.39|||Repeated Measures MANOVA|||||0.39|-0.09|0.76
72548330|NCT00663871|144626080|SUPERIORITY_OR_OTHER_LEGACY||standardized mean difference|0.06||||0.62|TWO_SIDED|95.0|-0.18|0.3|||Repeated Measures MANOVA|||||0.30|-0.18|0.62
72582028|NCT06192589|144694682|OTHER|A difference in exposure was concluded if the 2-sided 90% CI of the geometric mean ratio excluded 1, which is standard in pharmacokinetic studies|Geometric mean ratio|1.06||||0.34|TWO_SIDED|90.0|0.96|1.16|||Mixed Models Analysis|Analyses are not adjusted for multiplicity.|Comparison was the effect of a single dose of cannabidiol on morphine compared to morphine alone.|Area under the curve was log-transformed and the values between groups were compared using a linear mixed effects model with group as a categorical variable and subject as a random effect||1.16|0.96|0.34
72582029|NCT06192589|144694682|OTHER|A difference in exposure was concluded if the 2-sided 90% CI of the geometric mean ratio excluded 1, which is standard in pharmacokinetic studies|Geometric mean ratio|1.12||||0.1|TWO_SIDED|90.0|1.0|1.26|||Mixed Models Analysis|Analyses are not adjusted for multiplicity.|Comparison was the effect of a multiple doses of cannabidiol on morphine compared to morphine alone.|Area under the curve was log-transformed and the values between groups were compared using a linear mixed effects model with group as a categorical variable and subject as a random effect.||1.26|1.00|0.10
72582030|NCT06192589|144694683|OTHER|A difference in exposure was concluded if the 2-sided 90% CI of the geometric mean ratio excluded 1, which is standard in pharmacokinetic studies|Geometric mean ratio|1.19||||0.02|TWO_SIDED|90.0|1.05|1.35|||Mixed Models Analysis|Analyses are not adjusted for multiplicity.|Comparison was the effect of a single dose of cannabidiol on morphine compared to morphine alone.|Maximum concentration was log-transformed and the values between groups were compared using a linear mixed effects model with group as a categorical variable and subject as a random effect||1.35|1.05|0.02
72412374|NCT02034578|144332755|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|0.968|||||TWO_SIDED|90.0|0.926|1.011||||||B versus A||1.011|0.926|
72548331|NCT00663871|144626081|SUPERIORITY_OR_OTHER_LEGACY||standardized mean difference|0.03||||0.42|TWO_SIDED|95.0|-0.21|0.26|||Repeated Measures MANOVA|||||0.26|-0.21|0.42
72548332|NCT00663871|144626082|SUPERIORITY_OR_OTHER_LEGACY||Standardized mean difference|-0.06||||0.54|TWO_SIDED|95.0|-0.3|0.18|||Repeated Measures MANOVA|Repeated Measures MANOVA||||0.18|-0.30|0.54
72548333|NCT02739984|144626107|SUPERIORITY|Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|LS Mean Treatment Difference|-64.14|STANDARD_ERROR_OF_MEAN|2.05|<|0.0001|TWO_SIDED|95.0|-68.16|-60.12|||Repeated measures linear effects model|Model includes treatment group, stratification factor (screening LDL-C level), scheduled visit and the interaction of treatment with scheduled visit.|Evolocumab - Placebo|||-60.12|-68.16|<0.0001
72548334|NCT02739984|144626108|SUPERIORITY|Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|LS Mean Treatment Difference|-53.14|STANDARD_ERROR_OF_MEAN|2.25|<|0.0001|TWO_SIDED|95.0|-57.56|-48.71|||Repeated measures linear effects model|Model includes treatment group, stratification factor (screening LDL-C level), scheduled visit and the interaction of treatment with scheduled visit.|Evolocumab - Placebo|||-48.71|-57.56|<0.0001
72548335|NCT02739984|144626109|SUPERIORITY|Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|LS Mean Treatment Difference|-67.2|STANDARD_ERROR_OF_MEAN|2.5|<|0.0001|TWO_SIDED|95.0|-72.1|-62.2|||Repeated measures linear effects model|Model includes treatment group, stratification factor (screening LDL-C level), scheduled visit and the interaction of treatment with scheduled visit.|Evolocumab - Placebo|||-62.2|-72.1|<0.0001
72548336|NCT02739984|144626110|SUPERIORITY|Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|LS Mean Treatment Difference|-55.8|STANDARD_ERROR_OF_MEAN|2.7|<|0.0001|TWO_SIDED|95.0|-61.0|-50.5|||Repeated measures linear effects model|Model includes treatment group, stratification factor (screening LDL-C level), scheduled visit and the interaction of treatment with scheduled visit.|Evolocumab - Placebo|||-50.5|-61.0|<0.0001
72548337|NCT02739984|144626111|SUPERIORITY|Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|LS Mean Treatment Difference|-56.56|STANDARD_ERROR_OF_MEAN|1.89|<|0.0001|TWO_SIDED|95.0|-60.28|-52.85|||Repeated measures linear effects model|Model includes treatment group, stratification factor (screening LDL-C level), scheduled visit and the interaction of treatment with scheduled visit.|Evolocumab - Placebo|||-52.85|-60.28|<0.0001
72412375|NCT02034578|144332755|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|0.922|||||TWO_SIDED|90.0|0.899|0.947||||||C versus A||0.947|0.899|
72582031|NCT06192589|144694683|OTHER|A difference in exposure was concluded if the 2-sided 90% CI of the geometric mean ratio excluded 1, which is standard in pharmacokinetic studies|Geometric mean ratio|1.11||||0.29|TWO_SIDED|90.0|0.94|1.3|||Mixed Models Analysis|Analyses are not adjusted for multiplicity.|Comparison was the effect of multiple doses of cannabidiol on morphine compared to morphine alone.|Maximum concentration was log-transformed and the values between groups were compared using a linear mixed effects model with group as a categorical variable and subject as a random effect||1.30|0.94|0.29
72582032|NCT06192589|144694690|OTHER|A difference in exposure was concluded if the 2-sided 90% CI of the geometric mean ratio excluded 1, which is standard in pharmacokinetic studies|Geometric mean ratio|1.01||||0.47|TWO_SIDED|90.0|0.98|1.05|||Mixed Models Analysis|Analyses are not adjusted for multiplicity.|Comparison was the effect of a single dose of cannabidiol on morphine compared to morphine alone.|Area under the curve was log-transformed and the values between groups were compared using a linear mixed effects model with group as a categorical variable and subject as a random effect||1.05|0.98|0.47
72548338|NCT02739984|144626112|SUPERIORITY|Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|LS Mean Treatment Difference|-46.28|STANDARD_ERROR_OF_MEAN|2.1|<|0.0001|TWO_SIDED|95.0|-50.42|-42.15|||Repeated measures linear effects model|Model includes treatment group, stratification factor (screening LDL-C level), scheduled visit and the interaction of treatment with scheduled visit.|Evolocumab - Placebo|||-42.15|-50.42|<0.0001
72548339|NCT02739984|144626113|SUPERIORITY|Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|LS Mean Treatment Difference|-52.48|STANDARD_ERROR_OF_MEAN|1.85|<|0.0001|TWO_SIDED|95.0|-56.1|-48.85|||Repeated measures linear effects model|Model includes treatment group, stratification factor (screening LDL-C level), scheduled visit and the interaction of treatment with scheduled visit.|Evolocumab - Placebo|||-48.85|-56.10|<0.0001
72548340|NCT02739984|144626114|SUPERIORITY|Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|LS Mean Treatment Difference|-42.12|STANDARD_ERROR_OF_MEAN|2.04|<|0.0001|TWO_SIDED|95.0|-46.13|-38.11|||Repeated measures linear effects model|Model includes treatment group, stratification factor (screening LDL-C level), scheduled visit and the interaction of treatment with scheduled visit.|Evolocumab - Placebo|||-38.11|-46.13|<0.0001
72548341|NCT02739984|144626115|SUPERIORITY|Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|LS Mean Treatment Difference|-41.06|STANDARD_ERROR_OF_MEAN|1.44|<|0.0001|TWO_SIDED|95.0|-43.9|-38.22|||Repeated measures linear effects model|Model includes treatment group, stratification factor (screening LDL-C level), scheduled visit and the interaction of treatment with scheduled visit.|Evolocumab - Placebo|||-38.22|-43.90|<0.0001
72548342|NCT02739984|144626116|SUPERIORITY|Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|LS Mean Treatment Difference|-33.74|STANDARD_ERROR_OF_MEAN|1.59|<|0.0001|TWO_SIDED|95.0|-36.87|-30.6|||Repeated measures linear effects model|Model includes treatment group, stratification factor (screening LDL-C level), scheduled visit and the interaction of treatment with scheduled visit.|Evolocumab - Placebo|||-30.60|-36.87|<0.0001
72548343|NCT02739984|144626117|SUPERIORITY|Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Treatment Difference|77.9|||<|0.0001|TWO_SIDED|95.0|70.0|83.5|||Cochran-Mantel-Haenszel|Cochran Mantel Haenszel (CMH) test adjusted by the stratification factor (screening LDL-C level).|Evolocumab - Placebo|||83.5|70.0|<0.0001
72548344|NCT02739984|144626118|SUPERIORITY|Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Treatment Difference|69.1|||<|0.0001|TWO_SIDED|95.0|60.4|75.7|||Cochran-Mantel-Haenszel|Cochran Mantel Haenszel (CMH) test adjusted by the stratification factor (screening LDL-C level).|Evolocumab - Placebo|||75.7|60.4|<0.0001
72548345|NCT02739984|144626119|SUPERIORITY|Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Treatment Difference|83.5|||<|0.0001|TWO_SIDED|95.0|77.7|87.4|||Cochran-Mantel-Haenszel|Cochran Mantel Haenszel (CMH) test adjusted by the stratification factor (screening LDL-C level).|Evolocumab - Placebo|||87.4|77.7|<0.0001
72548346|NCT02739984|144626120|SUPERIORITY|Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Treatment Difference|64.7|||<|0.0001|TWO_SIDED|95.0|57.7|70.3|||Cochran-Mantel-Haenszel|Cochran Mantel Haenszel (CMH) test adjusted by the stratification factor (screening LDL-C level).|Evolocumab - Placebo|||70.3|57.7|<0.0001
72548347|NCT02739984|144626121|SUPERIORITY|Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|LS Mean Treatment Difference|-40.5|STANDARD_ERROR_OF_MEAN|3.87|<|0.0001|TWO_SIDED|95.0|-48.11|-32.9|||Repeated measures linear effects model|Model includes treatment group, stratification factor (screening LDL-C level), scheduled visit and the interaction of treatment with scheduled visit.|Evolocumab - Placebo|||-32.90|-48.11|<0.0001
72548348|NCT02739984|144626122|SUPERIORITY|Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|LS Mean Treatment Difference|-32.56|STANDARD_ERROR_OF_MEAN|3.57|<|0.0001|TWO_SIDED|95.0|-39.58|-25.53|||Repeated measures linear effects model|Model includes treatment group, stratification factor (screening LDL-C level), scheduled visit and the interaction of treatment with scheduled visit.|Evolocumab - Placebo|||-25.53|-39.58|<0.0001
72548349|NCT02739984|144626123|SUPERIORITY|Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|LS Mean Treatment Difference|-19.25|STANDARD_ERROR_OF_MEAN|3.41|<|0.0001|TWO_SIDED|95.0|-25.95|-12.54|||Repeated measures linear effects model|Model includes treatment group, stratification factor (screening LDL-C level), scheduled visit and the interaction of treatment with scheduled visit.|Evolocumab - Placebo|||-12.54|-25.95|<0.0001
72548350|NCT02739984|144626124|SUPERIORITY|Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|LS Mean Treatment Difference|-13.7|STANDARD_ERROR_OF_MEAN|4.02|<|0.0001|TWO_SIDED|95.0|-21.6|-5.8|||Repeated measures linear effects model|Model includes treatment group, stratification factor (screening LDL-C level), scheduled visit and the interaction of treatment with scheduled visit.|Evolocumab - Placebo|||-5.80|-21.60|<0.0001
72412376|NCT00116805|144332768|NON_INFERIORITY_OR_EQUIVALENCE|With a sample size of 160 subjects in the TDF group and 80 subjects in the ADV group, a two group large-sample normal approximation test of proportions with a one-sided 0.025 significance level would have 95% power to reject the null hypothesis that the TDF treatment was inferior to the ADV treatment (the difference in proportions was less than -0.080) in favor of the alternative hypothesis that the TDF treatment was not inferior.|Difference in proportions|54.1|STANDARD_ERROR_OF_MEAN|4.8|<|0.001|TWO_SIDED|95.0|44.6|63.6||P-value corresponds to a Z-test of the null hypothesis that the stratum-adjusted (baseline ALT ≤ 4 x upper limit of the normal range \[ULN\] or \> 4 x ULN) difference is 0.|Z-test|2-sided 95% confidence interval (CI), stratified by baseline ALT was used to evaluate difference between groups in proportion of complete responders.||||63.6|44.6|<0.001
72412377|NCT00116805|144332769|SUPERIORITY_OR_OTHER||Difference in proportions|63.1|STANDARD_ERROR_OF_MEAN|4.7|<|0.001|TWO_SIDED|95.0|53.8|72.3||P-value corresponds to a Z-test of the null hypothesis that the stratum-adjusted difference in zero.|Z-test|Difference, standard error of the difference, and the CI are stratum adjusted based on baseline ALT category (≤ 4 x ULN or \> 4 x ULN).||||72.3|53.8|<0.001
72412378|NCT00116805|144332770|SUPERIORITY_OR_OTHER||Difference in proportions|-1.4|STANDARD_ERROR_OF_MEAN|5.4||0.801|TWO_SIDED|95.0|-12.0|9.3||P-value corresponds to a Z-test of the null hypothesis that the stratum-adjusted difference is zero.|Z-test|Two-sided 95% CIs, stratified by baseline ALT (baseline ALT ≤ 4 x ULN or \> 4 x ULN), were used to evaluate treatment group differences.||||9.3|-12.0|0.801
72412379|NCT00116805|144332775|SUPERIORITY_OR_OTHER||Difference in proportions|5.8|STANDARD_ERROR_OF_MEAN|5.8||0.32|TWO_SIDED|95.0|-5.6|17.2||P-value corresponds to a Z-test of the null hypothesis that the stratum-adjusted difference in zero. Difference, standard error of the difference, and the CI are stratum adjusted based on baseline ALT category (≤ 4 x ULN or \> 4 x ULN).|Z-test|||||17.2|-5.6|0.320
72412380|NCT00116805|144332781|SUPERIORITY_OR_OTHER||Difference in proportions|13.6|STANDARD_ERROR_OF_MEAN|6.4||0.032|TWO_SIDED|95.0|1.1|26.1||P-value corresponds to a Z-test. Statistical tests were not adjusted for baseline ALT stratum.|Z-test|Difference, standard error of the difference, and CI are stratum adjusted (baseline ALT ≤ 4 x ULN or \> 4 x ULN).||||26.1|1.1|0.032
72412381|NCT00116805|144332782|SUPERIORITY_OR_OTHER||Difference in proportions|-9.8|STANDARD_ERROR_OF_MEAN|6.0||0.1|TWO_SIDED|95.0|-21.5|1.9||P-value corresponds to a Z-test of the null hypothesis that the ALT stratum-adjusted difference is zero.|Z-test|Difference, standard error of the difference, and CI are stratum adjusted (baseline ALT ≤ 4 x ULN or \> 4 x ULN).||||1.9|-21.5|0.100
72412382|NCT00116805|144332787|SUPERIORITY_OR_OTHER||Difference in proportions|6.1|STANDARD_ERROR_OF_MEAN|5.3||0.245|TWO_SIDED|95.0|-4.2|16.4||P-value above for HBeAg loss corresponds to a Z-test of the null hypothesis that stratum-adjusted difference is zero.|Z-test|Difference, standard error of the difference, and Cl are stratum adjusted based on baseline ALT category (≤ 4 x ULN or \> 4 x ULN).||This information pertains to HBeAg loss.||16.4|-4.2|0.245
72548351|NCT02739984|144626125|SUPERIORITY|Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|LS Mean Treatment Difference|9.8|STANDARD_ERROR_OF_MEAN|1.45|<|0.0001|TWO_SIDED|95.0|6.95|12.64|||Repeated measures linear effects model|Model includes treatment group, stratification factor (screening LDL-C level), scheduled visit and the interaction of treatment with scheduled visit.|Evolocumab - Placebo|||12.64|6.95|<0.0001
72548352|NCT02739984|144626126|SUPERIORITY|Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|LS Mean Treatment Difference|7.37|STANDARD_ERROR_OF_MEAN|1.62|<|0.0001|TWO_SIDED|95.0|4.19|10.56|||Repeated measures linear effects model|Model includes treatment group, stratification factor (screening LDL-C level), scheduled visit and the interaction of treatment with scheduled visit.|Evolocumab - Placebo|||10.56|4.19|<0.0001
72548353|NCT02739984|144626127|SUPERIORITY|Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|LS Mean Treatment Difference|-17.06|STANDARD_ERROR_OF_MEAN|2.98|<|0.0001|TWO_SIDED|95.0|-22.91|-11.21|||Repeated measures linear effects model|Model includes treatment group, stratification factor (screening LDL-C level), scheduled visit and the interaction of treatment with scheduled visit.|Evolocumab - Placebo|||-11.21|-22.91|<0.0001
72582033|NCT06192589|144694690|OTHER|A difference in exposure was concluded if the 2-sided 90% CI of the geometric mean ratio excluded 1, which is standard in pharmacokinetic studies|Geometric mean ratio|0.99||||0.73|TWO_SIDED|90.0|0.96|1.03|||Mixed Models Analysis|Analyses are not adjusted for multiplicity.|Comparison was the effect of multiple doses of cannabidiol on morphine compared to morphine alone.|Area under the curve was log-transformed and the values between groups were compared using a linear mixed effects model with group as a categorical variable and subject as a random effect||1.03|0.96|0.73
72412383|NCT00116805|144332787|SUPERIORITY_OR_OTHER||Difference in proportions|4.7|STANDARD_ERROR_OF_MEAN|5.2||0.363|TWO_SIDED|95.0|-5.5|14.9||P-value for HBeAg seroconversion corresponds to Z-test of the null hypothesis that stratum-adjusted difference is zero.|Z-test|Difference, standard error of difference, and Cl are stratum adjusted based on baseline ALT category (≤ 4 x ULN or \> 4 x ULN).||This information pertains to HBeAg seroconversion.||14.9|-5.5|0.363
72412384|NCT00116805|144332788|SUPERIORITY_OR_OTHER||Difference in proportions|0.3|STANDARD_ERROR_OF_MEAN|5.9||0.963|TWO_SIDED|95.0|-11.3|11.9||P-value above for HBeAg loss corresponds to a Z-test of the null hypothesis that stratum-adjusted difference is zero.|Z-test|Difference, standard error of the difference, and Cl are stratum adjusted based on baseline ALT category (≤ 4 x ULN or \> 4 x ULN).||This information pertains to HBeAg loss.||11.9|-11.3|0.963
72412385|NCT00116805|144332788|SUPERIORITY_OR_OTHER||Difference in proportions|0.7|STANDARD_ERROR_OF_MEAN|5.6||0.904|TWO_SIDED|95.0|-10.4|11.7||P-value above for HBeAg loss corresponds to a Z-test of the null hypothesis that stratum-adjusted difference is zero.|Z-test|Difference, standard error of the difference, and Cl are stratum adjusted based on baseline ALT category (≤ 4 x ULN or \>4 x ULN).||This information pertains to seroconversion to anti-HBe.||11.7|-10.4|0.904
72412386|NCT00116805|144332789|SUPERIORITY_OR_OTHER||Difference in proportions|10.9|STANDARD_ERROR_OF_MEAN|4.6||0.018|TWO_SIDED|95.0|1.9|19.9||P-value corresponds to a Z-test of the null hypothesis that the ALT stratum-adjusted difference is zero. Difference, standard error of the difference, and confidence interval (CI) are stratum adjusted (baseline ALT ≤ 4 x ULN or \> 4 x ULN).|Z-test|||This information pertains to HBsAg loss.||19.9|1.9|0.018
72582034|NCT06192589|144694691|OTHER|A difference in exposure was concluded if the 2-sided 90% CI of the geometric mean ratio excluded 1, which is standard in pharmacokinetic studies|Geometric mean ratio|1.12||||0.03|TWO_SIDED|90.0|1.03|1.21|||Mixed Models Analysis|Analyses are not adjusted for multiplicity.|Comparison was the effect of a single dose of cannabidiol on morphine compared to morphine alone.|Maximum concentration was log-transformed and the values between groups were compared using a linear mixed effects model with group as a categorical variable and subject as a random effect||1.21|1.03|0.03
72582035|NCT06192589|144694691|OTHER|A difference in exposure was concluded if the 2-sided 90% CI of the geometric mean ratio excluded 1, which is standard in pharmacokinetic studies|Geometric mean ratio|0.98||||0.66|TWO_SIDED|90.0|0.91|1.06|||Mixed Models Analysis|Analyses are not adjusted for multiplicity.|Comparison was the effect of multiple doses of cannabidiol on morphine compared to morphine alone.|Maximum concentration was log-transformed and the values between groups were compared using a linear mixed effects model with group as a categorical variable and subject as a random effect||1.06|0.91|0.66
72582036|NCT06192589|144694692|OTHER|A difference in exposure was concluded if the 2-sided 90% CI of the geometric mean ratio excluded 1, which is standard in pharmacokinetic studies.|Geometric mean ratio|1.08||||0.13|TWO_SIDED|90.0|0.99|1.18|||Mixed Models Analysis|Analyses are not adjusted for multiplicity.|Comparison was the effect of a single dose of cannabidiol on morphine compared to morphine alone.|Area under the curve was log-transformed and the values between groups were compared using a linear mixed effects model with group as a categorical variable and subject as a random effect.||1.18|0.99|0.13
72412387|NCT00116805|144332789|SUPERIORITY_OR_OTHER||Difference in proportions|4.3|STANDARD_ERROR_OF_MEAN|3.0||0.148|TWO_SIDED|95.0|-1.5|10.2||P-value corresponds to a Z-test of the null hypothesis that the ALT stratum-adjusted difference is zero. Difference, standard error of the difference, and confidence interval (CI) are stratum adjusted (baseline ALT ≤ 4 x ULN or \> 4 x ULN).|Z-test|||This information pertains to HBsAg seroconversion.||10.2|-1.5|0.148
72582037|NCT06192589|144694692|OTHER|A difference in exposure was concluded if the 2-sided 90% CI of the geometric mean ratio excluded 1, which is standard in pharmacokinetic studies|Geometric mean ratio|1.26|||<|0.01|TWO_SIDED|90.0|1.17|1.36|||Mixed Models Analysis|Analyses are not adjusted for multiplicity.|Comparison was the effect of multiple doses of cannabidiol on morphine compared to morphine alone.|Area under the curve was log-transformed and the values between groups were compared using a linear mixed effects model with group as a categorical variable and subject as a random effect||1.36|1.17|<0.01
72412388|NCT00116805|144332790|SUPERIORITY_OR_OTHER||Difference in proportions|0.9|STANDARD_ERROR_OF_MEAN|2.9||0.757|TWO_SIDED|95.0|-4.8|6.5||P-value above for HBsAg loss corresponds to a Z-test of the null hypothesis that stratum-adjusted difference is zero. Difference, standard error of the difference, and CI are stratum adjusted based on baseline ALT category (≤ 4 x ULN or \> 4 x ULN).|Z-test|||This information pertains to HBsAg loss.||6.5|-4.8|0.757
72548354|NCT02739984|144626128|SUPERIORITY|Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|LS Mean Treatment Difference|-13.33|STANDARD_ERROR_OF_MEAN|3.44|<|0.0001|TWO_SIDED|95.0|-20.09|-6.56|||Repeated measures linear effects model|Model includes treatment group, stratification factor (screening LDL-C level), scheduled visit and the interaction of treatment with scheduled visit.|Evolocumab - Placebo|||-6.56|-20.09|<0.0001
72548355|NCT00097695|144626134|SUPERIORITY_OR_OTHER_LEGACY|||||||0.142||95.0|||||Wilcoxon version of the log-rank test|The Wilcoxon version of the log-rank test of SAS was used to calculate statistical significance between p- vs icatibant group and placebo group.||||||0.142
72548356|NCT00097695|144626135|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||Wilcoxon version of the log-rank test|The median time to onset is calculated using Kaplan-Meier methodology. The Wilcoxon version of the log-rank test of SAS is used.||||||< 0.001
72548357|NCT00097695|144626136|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.079||95.0|||||Wilcoxon version of the log-rank test|The median time to almost complete symptom relief was calculated using Kaplan-Meier methodology.The Wilcoxon version of the log-rank test of SAS used.||||||= 0.079
72548358|NCT01691508|144626221|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.39||||0.008|TWO_SIDED|95.0|1.25|4.56|||Proportional odds model|||||4.56|1.25|0.008
72548359|NCT03238677|144626252|SUPERIORITY||Mean Difference (Final Values)|-10.0||||0.132|TWO_SIDED|95.0|-23.2|3.1|||Mixed Models Analysis|||Main effect of biofeedback at 10 weeks||3.1|-23.2|.132
72548360|NCT03238677|144626252|SUPERIORITY||Mean Difference (Final Values)|-13.7||||0.028|TWO_SIDED|95.0|-25.9|-1.5|||Mixed Models Analysis|||Main effect of Practice Distribution at 10 weeks||-1.5|-25.9|.028
72548361|NCT03238677|144626252|SUPERIORITY||Mean Difference (Final Values)|-10.0||||0.187|TWO_SIDED|95.0|-24.9|5.0|||Mixed Models Analysis|||Main effect comparing telepractice vs face-to-face treatment||5.0|-24.9|.187
72548362|NCT03238677|144626252|SUPERIORITY||Mean Difference (Final Values)|20.22||||0.125|TWO_SIDED|95.0|-5.8|46.3|||Mixed Models Analysis|||Interaction of biofeedback and practice distribution at 10 weeks|η2 =.054|46.3|-5.8|.125
72548363|NCT02433665|144626255|NON_INFERIORITY|The primary end point for this study was a comparison between fixed-dose and customized-dose contrast material injection CT protocols for vascular and parenchymal enhancement by using a noninferiority approach. The limit of noninferiority was set at 0.1 before the initiation of the study on the basis of a similar study that examined contrast media dose optimization for CT angiography examinations.|Odds Ratio, log|0.75|STANDARD_DEVIATION|0.35|>|0.05|TWO_SIDED|0.38|||||Mixed Models Analysis|||||||>0.05
72548364|NCT03702621|144626256|OTHER|P values are from mixed model least squares (LS) means differences with Sidak adjustment for multiple comparisons.||||||0.54|||||||Mixed Models Analysis|Sidak adjustment||||||0.54
72548365|NCT03702621|144626257|OTHER|P values are from mixed model LS means differences with Sidak adjustment for multiple comparisons.||||||0.59|||||||Mixed Models Analysis|||||||0.59
72548366|NCT03702621|144626258|OTHER|P values are from mixed model LS means differences with Sidak adjustment for multiple comparisons||||||0.98||||||P values are from mixed model LS means differences with Sidak adjustment for multiple comparisons|Mixed Models Analysis|Sidak adjustment||||||0.98
72548367|NCT03702621|144626259|OTHER|P values are from mixed model LS means differences with Sidak adjustment for multiple comparisons||||||0.94||||||P values are from mixed model LS means differences with Sidak adjustment for multiple comparisons|Mixed Models Analysis|Sidak adjustment||||||0.94
72548368|NCT03702621|144626260|OTHER|P values are from mixed model LS means differences with Sidak adjustment for multiple comparisons||||||0.86|||||||Mixed Models Analysis|Sidak adjustment||P values are from mixed model LS means differences with Sidak adjustment for multiple comparisons||||0.86
72548369|NCT03702621|144626261|OTHER|P values are from mixed model LS means differences with Sidak adjustment for multiple comparisons||||||1||||||P values are from mixed model LS means differences with Sidak adjustment for multiple comparisons|Mixed Models Analysis|Sidak adjustment||||||1.0
72548370|NCT03702621|144626262|OTHER|P values are from mixed model LS means differences with Sidak adjustment for multiple comparisons.||||||0.99|||||||Mixed Models Analysis|||||||0.99
72548371|NCT03702621|144626263|OTHER|P values are from mixed model LS means differences with Sidak adjustment for multiple comparisons.||||||0.99|||||||Mixed Models Analysis|||||||0.99
72548372|NCT03702621|144626264|OTHER|P values are from mixed model LS means differences with Sidak adjustment for multiple comparisons.||||||0.72|||||||Mixed Models Analysis|||||||0.72
72548373|NCT03702621|144626265|OTHER|P values are from mixed model LS means differences with Sidak adjustment for multiple comparisons.||||||0.29|||||||Mixed Models Analysis|||||||0.29
72548374|NCT03702621|144626266|OTHER|P values are from mixed model LS means differences with Sidak adjustment for multiple comparisons.||||||0.46|||||||Mixed Models Analysis|||||||0.46
72548375|NCT03702621|144626267|OTHER|P values are from mixed model LS means differences with Sidak adjustment for multiple comparisons.||||||0.77|||||||Mixed Models Analysis|||||||0.77
72548376|NCT01439165|144626324|NON_INFERIORITY|Non-inferiority concluded if the lower limit of the 2-sided 95% Confidence Interval (CI) of the difference of seroprotection rates between groups is \> -10%|Difference (%) in Adacel-Td Adsorbed|0.0|||||TWO_SIDED|95.0|-0.4|1.2||||||Comparison of anti-tetanus seroprotection rate between the two groups||1.2|-0.4|
72548377|NCT01439165|144626324|NON_INFERIORITY|Non-inferiority concluded if the lower limit of the 2-sided 95% CI of the difference of seroprotection rates between groups is \> -10%|Difference (%) in Adacel-Td Adsorbed|0.42|||||TWO_SIDED|95.0|-0.3|2.1||||||Comparison of anti-diphtheria seroprotection rates between the two groups||2.1|-0.3|
72548378|NCT01439165|144626325|NON_INFERIORITY|Non-inferiority concluded if the lower limit of the 2-sided 95% CI of the difference of booster response rates between groups is \> -10%|Difference (%) in Adacel-Td Adsorbed|-7.12|||||TWO_SIDED|95.0|-12.0|-1.7||||||Comparison of the anti-tetanus booster response rates between the two groups||-1.7|-12.0|
72582038|NCT06192589|144694693|OTHER|A difference in exposure was concluded if the 2-sided 90% CI of the geometric mean ratio excluded 1, which is standard in pharmacokinetic studies|Geometric mean ratio|1.08||||0.12|TWO_SIDED|90.0|1.0|1.17|||Mixed Models Analysis|Analyses are not adjusted for multiplicity.|Comparison was the effect of a single dose of cannabidiol on morphine compared to morphine alone.|Maximum concentration was log-transformed and the values between groups were compared using a linear mixed effects model with group as a categorical variable and subject as a random effect||1.17|1.00|0.12
72582039|NCT06192589|144694693|OTHER|A difference in exposure was concluded if the 2-sided 90% CI of the geometric mean ratio excluded 1, which is standard in pharmacokinetic studies|Geometric mean ratio|1.11||||0.07|TWO_SIDED|90.0|1.01|1.21|||Mixed Models Analysis|Analyses are not adjusted for multiplicity.|Comparison was the effect of multiple doses of cannabidiol on morphine compared to morphine alone.|Maximum concentration was log-transformed and the values between groups were compared using a linear mixed effects model with group as a categorical variable and subject as a random effect||1.21|1.01|0.07
72548379|NCT01439165|144626325|NON_INFERIORITY|Non-inferiority concluded if the lower limit of the 2-sided 95% CI of the difference of booster response rates between groups is \> -10%|Difference (%) in Adacel-Td Adsorbed|-0.95|||||TWO_SIDED|95.0|-5.4|4.0||||||Comparison of the anti-diphteria booster response rates between the two groups||4.0|-5.4|
72548380|NCT01439165|144626326|NON_INFERIORITY|Non-inferiority concluded if the lower limit of the 2-sided 95% CI of the ratio of GMCs between groups is \> 0.66|GMC ratio (Adacel/Historical Control)|1.04|||||TWO_SIDED|95.0|0.92|1.18||||||Comparison of anti-pertussis toxoid GMCs between Adacel and historical control groups||1.18|0.92|
72548381|NCT01439165|144626326|NON_INFERIORITY|Non-inferiority concluded if the lower limit of the 2-sided 95% CI of the ratio of GMCs between groups is \> 0.66|GMC Ratio (Adacel/Historical Control)|5.22|||||TWO_SIDED|95.0|4.51|6.05||||||Comparison of the anti-FHA GMCs between Adacel and historical Control groups||6.05|4.51|
72548382|NCT01439165|144626326|NON_INFERIORITY|Non-inferiority concluded if the lower limit of the 2-sided 95% CI of the ratio of GMCs between groups is \> 0.66|GMC Ratio (Adacel/Historical Control)|2.94|||||TWO_SIDED|95.0|2.46|3.51||||||Comparison of the anti-Pertactin GMCs between Adacel and historical Control groups||3.51|2.46|
72548383|NCT01439165|144626326|NON_INFERIORITY|Non-inferiority concluded if the lower limit of the 2-sided 95% CI of the ratio of GMCs between groups is \> 0.66|GMC Ratio (Adacel/Historical Control)|2.18|||||TWO_SIDED|95.0|1.84|2.6||||||Comparison of the post-vaccination anti-Fimbriae (types 2 and 3) GMCs between Adacel and historical Control groups||2.60|1.84|
72548384|NCT01439165|144626327|NON_INFERIORITY|Non-inferiority concluded if the lower limit of the 2-sided 95% CI of the difference of booster response rates between groups is \> -10% .|Difference (%) Adacel-Expected Booster|16.12|||||TWO_SIDED|95.0|13.27|18.73||||||comparison of anti-pertussis toxoid booster response rates was performed between the Adacel and historical groups||18.73|13.27|
72548385|NCT01439165|144626327|NON_INFERIORITY|Non-inferiority concluded if the lower limit of the 2-sided 95% CI of the difference of booster response rates between groups is \> -10%|Difference (%) Adacel-Expected Booster|-4.21|||||TWO_SIDED|95.0|-7.23|-1.34||||||Comparison of the anti-FHA booster response rates between the Adacel and historical groups||-1.34|-7.23|
72582040|NCT01866826|144694697|SUPERIORITY|||||||0.51|||||||Wilcoxon (Mann-Whitney)|||||||0.51
72582041|NCT01866826|144694698|SUPERIORITY|||||||||||||||||We calculated the proportion of pts with elevated viral levels \>50 copies/ml at each phase of the study.|We estimated that four of the seven patients would have an elevation in viral Ribonucleic Acid (RNA) level \>50 copies/ml.|||
72582042|NCT01866826|144694700|SUPERIORITY||Mean Difference (Net)|0.7872|||||TWO_SIDED|||||||||We calculated the percentage of total lymphocytes that were expressing activation markers at each time point, and compared the differences in the percentages in the Rifaximin and control groups. We used the Wilcoxon test to detect differences between the differences in percentages in the control and Rifaximin groups.||||
72548386|NCT01439165|144626327|NON_INFERIORITY|Non-inferiority concluded if the lower limit of the 2-sided 95% CI of the difference of booster response rates between groups is \> -10% .|Difference (%) Adacel-Expected Booster|-18.61|||||TWO_SIDED|95.0|-21.7|-15.6||||||Comparison of the anti-Pertactin booster response rates between Adacel and historical groups||-15.6|-21.7|
72548387|NCT01439165|144626327|NON_INFERIORITY|Non-inferiority concluded if the lower limit of the 2-sided 95% CI of the difference of booster response rates between groups is \> -10% .|Difference (%) Adacel-Expected Booster|-19.07|||||TWO_SIDED|95.0|-22.3|-16.0||||||Comparison of the anti-Fimbriae (types 2 and 3) booster response rates between Adacel and historical groups||-16.0|-22.3|
72548388|NCT00810368|144626329|SUPERIORITY_OR_OTHER|||||||0.3|TWO_SIDED|||||2-tailed paired Student's t-tests between Week 0 and Week 12 responses (above) were anticipated to show significant benefits with carnosine treatment but no change with placebo. There were no corrections for multiple comparisons in the reported data.|t-test, 2 sided|Paired t-test||Description of Power Calculation: The planned sample size completing each arm was based on individual incremental improvements in the primary outcomes of : A) CFS Severity Scores (Baraniuk et al., Annals Allergy Astma Immunol, 1998), B) Instantaneous Fatigue (Kim et al. Journal of Rehab Res Dev, 2010), and C) increased accuracy of 4/35 letters for 2 back working memory task (Owen, Human Brain Mapping, 2005).||||0.30
72548389|NCT00810368|144626329|SUPERIORITY_OR_OTHER|||||||0.4|TWO_SIDED||||||t-test, 2 sided|||||||0.40
72548390|NCT00810368|144626330|SUPERIORITY_OR_OTHER|||||||0.018|TWO_SIDED|||||Using Fisher's Exact Test, we determined whether there was a significant difference in the number of participants complaining of IBS symptoms.|Fisher Exact|2 by 2 Fisher's Exact Test||||||0.018
72548391|NCT00810368|144626331|SUPERIORITY_OR_OTHER|||||||0.0018|TWO_SIDED||||||t-test, 2 sided|||||||0.0018
72548392|NCT00810368|144626331|SUPERIORITY_OR_OTHER|||||||0.6|TWO_SIDED||||||t-test, 2 sided|||||||0.60
72548393|NCT00810368|144626333|SUPERIORITY_OR_OTHER|||||||0.5|TWO_SIDED||||||t-test, 2 sided|||||||0.5
72548394|NCT00810368|144626334|SUPERIORITY_OR_OTHER|||||||0.5|TWO_SIDED||||||t-test, 2 sided|||||||0.5
72548395|NCT00810368|144626335|SUPERIORITY_OR_OTHER|||||||0.5|TWO_SIDED||||||t-test, 2 sided|||||||0.50
72548396|NCT03365375|144626361|SUPERIORITY||Mean Difference (Final Values)|3.0||||0.82|TWO_SIDED||||||t-test, 2 sided|||||||0.82
72548397|NCT03879239|144626373|SUPERIORITY|||||||0.0011||||||Responder Rate on Weekly CSBM1 in the ITT (Intention to Treat) analysis set. (For details, refer to the primary outcome description).|Chi-squared|||||||0.0011
72548398|NCT03879239|144626373|SUPERIORITY|||||||0.0085||||||Responder Rate on Weekly CSBM2 in the ITT (Intention to Treat) analysis set. (For details, refer to the primary outcome description).|Chi-squared|||||||0.0085
72548399|NCT00266409|144626379|SUPERIORITY_OR_OTHER|||||||0.1143||95.0|||||Generalized Wilcoxon|||This analysis refers to the test of the null hypothesis that there is no difference in the survival distribution function between the treatment groups.||||0.1143
72548400|NCT00266409|144626379|SUPERIORITY_OR_OTHER|||||||0.4544||95.0|||||Generalized Wilcoxon|||This analysis refers to the test of the null hypothesis that there is no difference in the survival distribution function between the treatment groups.||||0.4544
72548401|NCT00266409|144626380|SUPERIORITY_OR_OTHER|||||||0.0173||95.0|||||ANCOVA|||ANCOVA with treatment as a fixed effect and baseline total HAM-A score as a covariate||||0.0173
72548402|NCT00266409|144626380|SUPERIORITY_OR_OTHER|||||||0.0516||95.0|||||ANCOVA|||ANCOVA with treatment as a fixed effect and baseline total HAM-A score as a covariate||||0.0516
72548403|NCT00266409|144626381|SUPERIORITY_OR_OTHER|||||||0.0361||95.0||||P-value based on ANCOVA model with treatment as a fixed effect and baseline total HAM-A score as a covariate|ANCOVA|||||||0.0361
72548404|NCT00266409|144626381|SUPERIORITY_OR_OTHER|||||||0.0366||95.0||||P-value based on ANCOVA model with treatment as a fixed effect and baseline total HAM-A score as a covariate|ANCOVA|||||||0.0366
72548405|NCT00266409|144626382|SUPERIORITY_OR_OTHER|||||||0.739||95.0||||P-value based on ANCOVA model with treatment as a fixed effect and baseline total HAM-A score as a covariate|ANCOVA|||||||0.7390
72548406|NCT00266409|144626382|SUPERIORITY_OR_OTHER|||||||0.6735||95.0||||P-value based on ANCOVA model with treatment as a fixed effect and baseline total HAM-A score as a covariate|ANCOVA|||||||0.6735
72582043|NCT01866826|144694700|SUPERIORITY|||||||0.54|||||||Wilcoxon|||We calculated the percentage of total lymphocytes that were expressing the activation markers at each time point, and compared the differences in the percentages in the Rifaximin and control groups. We used the T-test to detect differences between the differences in percentages in the control group and Rifaximin groups.||||0.54
72548407|NCT00266409|144626383|SUPERIORITY_OR_OTHER|||||||0.4261||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline total HAM-A score as a covariate|ANCOVA|||||||0.4261
72548408|NCT00266409|144626383|SUPERIORITY_OR_OTHER|||||||0.0231||95.0||||P-value based on ANCOVA with treatment as a fixed effect and baseline HAM-A score as a covariate|ANCOVA|||||||0.0231
72548409|NCT00266409|144626384|SUPERIORITY_OR_OTHER|||||||0.182||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and total HAM-A score as a covariate|ANCOVA|||||||0.1820
72548410|NCT00266409|144626384|SUPERIORITY_OR_OTHER|||||||0.2187||95.0||||P-value based on ANCOVA model with treatment as a fixed effect and baseline total HAM-A score as covariate|ANCOVA|||||||0.2187
72548411|NCT00266409|144626385|SUPERIORITY_OR_OTHER|||||||0.1456||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline total HAM-A score as a covariate|ANCOVA|||||||0.1456
72548412|NCT00266409|144626385|SUPERIORITY_OR_OTHER|||||||0.3618||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline total HAM-A score as a covariate|ANCOVA|||||||0.3618
72548413|NCT00266409|144626386|SUPERIORITY_OR_OTHER|||||||0.3535||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline total HAM-A score as a covariate|ANCOVA|||||||0.3535
72548414|NCT00266409|144626386|SUPERIORITY_OR_OTHER|||||||0.566||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline total HAM-A score as a covariate|ANCOVA|||||||0.5660
72548415|NCT00266409|144626387|SUPERIORITY_OR_OTHER|||||||0.3414||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline total HAM-A score as a covariate|ANCOVA|||||||0.3414
72548416|NCT00266409|144626387|SUPERIORITY_OR_OTHER|||||||0.7344||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline total HAM-A score as a covariate|ANCOVA|||||||0.7344
72548417|NCT00266409|144626388|SUPERIORITY_OR_OTHER|||||||0.1197||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline total HAM-A score as a covariate|ANCOVA|||||||0.1197
72548418|NCT00266409|144626388|SUPERIORITY_OR_OTHER|||||||0.4416||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline total HAM-A score as a covariate|ANCOVA|||||||0.4416
72548419|NCT00266409|144626389|SUPERIORITY_OR_OTHER|||||||0.035||95.0|||||Chi-squared|||Analysis refers to test of differences in response rates.||||0.0350
72548420|NCT00266409|144626389|SUPERIORITY_OR_OTHER|||||||0.4205||95.0|||||Chi-squared|||Analysis refers to test of differences in response rates.||||0.4205
72548421|NCT00266409|144626390|SUPERIORITY_OR_OTHER|||||||0.2645||95.0|||||Chi-squared|||Analysis refers to test of differences in response rates.||||0.2645
72548422|NCT00266409|144626390|SUPERIORITY_OR_OTHER|||||||0.5369||95.0|||||Chi-squared|||Analysis refers to test of differences in response rates.||||0.5369
72548423|NCT00266409|144626391|SUPERIORITY_OR_OTHER|||||||0.9988||95.0|||||Chi-squared|||Analysis refers to test of differences in response rates.||||0.9988
72548424|NCT00266409|144626391|SUPERIORITY_OR_OTHER|||||||0.7729||95.0|||||Chi-squared|||Analysis refers to test of differences in response rates.||||0.7729
72548425|NCT00266409|144626392|SUPERIORITY_OR_OTHER|||||||0.7338||95.0|||||Chi-squared|||Analysis refers to test of differences in response rates.||||0.7338
72548426|NCT00266409|144626392|SUPERIORITY_OR_OTHER|||||||0.0897||95.0|||||Chi-squared|||Analysis refers to test of differences in response rates.||||0.0897
72548427|NCT00266409|144626393|SUPERIORITY_OR_OTHER|||||||0.6501||95.0|||||Chi-squared|||Analysis refers to test of differences in response rates.||||0.6501
72548428|NCT00266409|144626393|SUPERIORITY_OR_OTHER|||||||0.8196||95.0|||||Chi-squared|||Analysis refers to test of differences in response rates.||||0.8196
72548429|NCT00266409|144626394|SUPERIORITY_OR_OTHER|||||||0.6404||95.0|||||Chi-squared|||Analysis refers to test of differences in response rates.||||0.6404
72548430|NCT00266409|144626394|SUPERIORITY_OR_OTHER|||||||0.8263||95.0|||||Chi-squared|||Analysis refers to test of differences in response rates.||||0.8263
72548431|NCT00266409|144626395|SUPERIORITY_OR_OTHER|||||||0.6946||95.0|||||Chi-squared|||Analysis refers to test of differences in response rates.||||0.6946
72548432|NCT00266409|144626395|SUPERIORITY_OR_OTHER|||||||0.9629||95.0|||||Chi-squared|||Analysis refers to test of differences in response rates.||||0.9629
72548433|NCT00266409|144626396|SUPERIORITY_OR_OTHER|||||||0.8617||95.0|||||Chi-squared|||Analysis refers to test of differences in response rates.||||0.8617
72548434|NCT00266409|144626396|SUPERIORITY_OR_OTHER|||||||0.7555||95.0|||||Chi-squared|||Analysis refers to test of differences in response rates.||||0.7555
72548435|NCT00266409|144626397|SUPERIORITY_OR_OTHER|||||||0.5836||95.0|||||Chi-squared|||Analysis refers to test of differences in response rates.||||0.5836
72548436|NCT00266409|144626397|SUPERIORITY_OR_OTHER|||||||0.9096||95.0|||||Chi-squared|||Analysis refers to test of differences in response rates.||||0.9096
72548437|NCT00266409|144626398|SUPERIORITY_OR_OTHER|||||||0.0002||95.0|||||van Elteren test|||van Elteren test stratified by CGI-Severity score at baseline and testing between treatment differences in percentages based on non-missing responses within a timepoint. CGI-Severity score categorizes severity at baseline as normal,not at all ill, borderline mentally ill, mildly ill, moderately ill, markedly ill, severely ill, among the most extremely ill.||||0.0002
72548438|NCT00266409|144626398|SUPERIORITY_OR_OTHER|||||||0.0006||95.0|||||van Elteren test|||van Elteren test stratified by CGI-Severity score at baseline and testing between treatment differences in percentages based on non-missing responses within a timepoint. CGI-Severity score categorizes severity at baseline as normal,not at all ill, borderline mentally ill, mildly ill, moderately ill, markedly ill, severely ill, among the most extremely ill.||||0.0006
72548439|NCT00266409|144626399|SUPERIORITY_OR_OTHER|||||||0.0255||95.0|||||van Elteren test|||van Elteren test stratified by CGI-Severity score at baseline and testing between treatment differences in percentages based on non-missing responses within a timepoint, CGI-Severity score categorizes severity at baseline as normal,not at all ill, borderline mentally ill, mildly ill, moderately ill, markedly ill, severely ill, among the most extremely ill.||||0.0255
72548440|NCT00266409|144626399|SUPERIORITY_OR_OTHER|||||||0.0065||95.0|||||van Elteren test|||van Elteren test stratified by CGI-Severity score at baseline and testing between treatment differences in percentages based on non-missing responses within a timepoint. CGI-Severity score categorizes severity at baseline as normal,not at all ill, borderline mentally ill, mildly ill, moderately ill, markedly ill, severely ill, among the most extremely ill.||||0.0065
72548441|NCT00266409|144626400|SUPERIORITY_OR_OTHER|||||||0.037||95.0|||||van Elteren test|||van Elteren test stratified by CGI-Severity score at baseline and testing between treatment differences in percentages on non-missing responses within a timepoint. CGI-Severity score categorizes severity at baseline as normal,not at all ill, borderline mentally ill, mildly ill, moderately ill, markedly ill, severely ill, among the most extremely ill.||||0.0370
72548442|NCT00266409|144626400|SUPERIORITY_OR_OTHER|||||||0.9569||95.0|||||van Elteren test|||van Elteren test stratified by CGI-Severity score at baseline and testing between treatment differences in percentages based on non-missing responses within a timepoint. CGI-Severity score categorizes severity at baseline as normal,not at all ill, borderline mentally ill, mildly ill, moderately ill, markedly ill, severely ill, among the most extremely ill.||||0.9569
72548443|NCT00266409|144626401|SUPERIORITY_OR_OTHER|||||||0.0978||95.0|||||van Elteren test|||van Elteren test stratified by CGI-Severity score at baseline and testing between treatment differences in percentages based on non-missing responses within a timepoint. CGI-Severity score categorizes severity at baseline as normal,not at all ill, borderline mentally ill, mildly ill, moderately ill, markedly ill, severely ill, among the most extremely ill.||||0.0978
72582044|NCT00742209|144694706|SUPERIORITY_OR_OTHER||Adjusted mean difference versus placebo|0.3||||0.579|TWO_SIDED|95.0|-0.6|1.1||A combination of a sequential method and the Hochberg procedure has been used to maintain the overall experiment-size alphas level of 0.05 for the comparison of GEn vs. placebo.|ANCOVA|An ANCOVA model with baseline number of MHD and IHS Headache Classification for presence or absence of aura as covariates was used.|Adjusted mean difference versus placebo|||1.1|-0.6|0.579
72582045|NCT02562066|144694725|OTHER||Mean Difference (Net)|1.63||||0.085|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||Results show the difference in mean CFB at the end of Study Period 1.|A Mann-Whitney-Wilcoxon test for equality of the change from baseline (CFB) in the two treatments in Period 1 will be presented.||||0.085
72548444|NCT00266409|144626401|SUPERIORITY_OR_OTHER|||||||0.7096||95.0|||||van Elteren test|||van Elteren test stratified by CGI-Severity score at baseline and testing between treatment differences in percentages based on non-missing responses within a timepoint. CGI-Severity score categorizes severity at baseline as normal,not at all ill, borderline mentally ill, mildly ill, moderately ill, markedly ill, severely ill, among the most extremely ill.||||0.7096
72548445|NCT00266409|144626402|SUPERIORITY_OR_OTHER|||||||0.0001||95.0|||||van Elteren test|||van Elteren test stratified by CGI-Severity score at baseline and testing between treatment differences in percentages based on non-missing responses within a timepoint. CGI-Severity score categorizes severity at baseline as normal,not at all ill, borderline mentally ill, mildly ill, moderately ill, markedly ill, severely ill, among the most extremely ill.||||0.0001
72548446|NCT00266409|144626402|SUPERIORITY_OR_OTHER|||||||0.0003||95.0|||||van Elteren test|||van Elteren test stratified by CGI-Severity score at baseline and testing between treatment differences in percentages based on non-missing responses within a timepoint. CGI-Severity score categorizes severity at baseline as normal,not at all ill, borderline mentally ill, mildly ill, moderately ill, markedly ill, severely ill, among the most extremely ill.||||0.0003
72582046|NCT02562066|144694725|OTHER||Mean Difference (Net)|0.56|||||TWO_SIDED|95.0|-0.97|2.09|||Mixed Models Analysis||Results show the LSMeans for the estimated difference between treatments in Period 1 along with a 95% confidence interval for this difference.|A mixed effects linear model will be fit to the data with SGI raw scores as the response and fixed effect terms for treatment, period, age group, mutation type and sequence\*period, and a random effect for patient. The LSMeans for the estimated difference between treatments in Period 1 along with a 95% confidence interval for this difference.||2.09|-0.97|
72582047|NCT02562066|144694726|OTHER||Mean Difference (Net)|3.17||||0.376|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||Results show the difference in mean CFB at the end of Study Period 1.|A Mann-Whitney-Wilcoxon test for equality of the change from baseline (CFB) in the two treatments in Period 1 will be presented.||||0.376
72548447|NCT00266409|144626403|SUPERIORITY_OR_OTHER|||||||0.0025||95.0|||||van Elteren test|||van Elteren test stratified by CGI-Severity score at baseline and testing between treatment differences in percentages based on non-missing responses within a timepoint. CGI-Severity score categorizes severity at baseline as normal,not at all ill, borderline mentally ill, mildly ill, moderately ill, markedly ill, severely ill, among the most extremely ill.||||0.0025
72582048|NCT02562066|144694726|OTHER||Mean Difference (Net)|1.14|||||TWO_SIDED|95.0|-2.31|4.58|||Mixed Models Analysis||Results show the LSMeans for the estimated difference between treatments in Period 1 along with a 95% confidence interval for this difference.|A mixed effects linear model will be fit to the data with Overall MFM-32 scores as the response and fixed effect terms for treatment, period, age group, mutation type and sequence\*period, and a random effect for patient. The LSMeans for the estimated difference between treatments in Period 1 along with a 95% confidence interval for this difference.||4.58|-2.31|
72582049|NCT02562066|144694727|OTHER||Mean Difference (Net)|-1.0||||0.8|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||Results show the difference in mean CFB at the end of Study Period 1.|A Mann-Whitney-Wilcoxon test for equality of the change from baseline (CFB) in the two treatments in Period 1 will be presented.||||0.800
72582050|NCT02562066|144694727|OTHER||Mean Difference (Net)|0.63|||||TWO_SIDED|95.0|-5.25|6.5|||Mixed Models Analysis||Results show the LSMeans for the estimated difference between treatments in Period 1 along with a 95% confidence interval for this difference.|A mixed effects linear model will be fit to the data with Overall MFM-20 scores as the response and fixed effect terms for treatment, period, age group, mutation type and sequence\*period, and a random effect for patient. The LSMeans for the estimated difference between treatments in Period 1 along with a 95% confidence interval for this difference.||6.50|-5.25|
72582051|NCT01998919|144694747|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.34|||||TWO_SIDED|95.0|-10.3|17.0|||||Approximate 95% CI for difference of two rates using Hauck-Anderson method.|||17.0|-10.3|
72582052|NCT01998919|144694748|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.63|||||TWO_SIDED|95.0|-5.6|26.8|||||Approximate 95% CI for difference of two rates using Hauck-Anderson method.|||26.8|-5.6|
72582053|NCT01998919|144694749|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.48|||||TWO_SIDED|95.0|-2.7|27.7|||||Approximate 95% CI for difference of two rates using Hauck-Anderson method.|||27.7|-2.7|
72548448|NCT00266409|144626403|SUPERIORITY_OR_OTHER|||||||0.0101||95.0|||||van Elteren test|||van Elteren test stratified by CGI-Severity score at baseline and testing between treatment differences in percentages based on non-missing responses within a timepoint. CGI-Severity score categorizes severity at baseline as normal,not at all ill, borderline mentally ill, mildly ill, moderately ill, markedly ill, severely ill, among the most extremely ill.||||0.0101
72548449|NCT00266409|144626404|SUPERIORITY_OR_OTHER|||||||0.0095||95.0|||||van Elteren test|||van Elteren test stratified by CGI-Severity score at baseline and testing between treatment differences in percentages based on non-missing responses within a timepoint. CGI-Severity score categorizes severity at baseline as normal,not at all ill, borderline mentally ill, mildly ill, moderately ill, markedly ill, severely ill, among the most extremely ill.||||0.0095
72548450|NCT00266409|144626404|SUPERIORITY_OR_OTHER|||||||0.039||95.0|||||van Elteren test|||van Elteren test stratified by CGI-Severity score at baseline and testing between treatment differences in percentages based on non-missing responses within a timepoint. CGI-Severity score categorizes severity at baseline as normal,not at all ill, borderline mentally ill, mildly ill, moderately ill, markedly ill, severely ill, among the most extremely ill.||||0.0390
72548451|NCT00266409|144626405|SUPERIORITY_OR_OTHER|||||||0.016||95.0|||||van Elteren test|||van Elteren test stratified by CGI-Severity score at baseline and testing between treatment differences in percentages based on non-missing responses within a timepoint. CGI-Severity score categorizes severity at baseline as normal,not at all ill, borderline mentally ill, mildly ill, moderately ill, markedly ill, severely ill, among the most extremely ill.||||0.0160
72548452|NCT00266409|144626405|SUPERIORITY_OR_OTHER|||||||0.1024||95.0|||||van Elteren test|||van Elteren test stratified by CGI-Severity score at baseline and testing between treatment differences in percentages based on non-missing responses within a timepoint. CGI-Severity score categorizes severity at baseline as normal,not at all ill, borderline mentally ill, mildly ill, moderately ill, markedly ill, severely ill, among the most extremely ill.||||0.1024
72548453|NCT00266409|144626406|SUPERIORITY_OR_OTHER|||||||0.0761||95.0|||||van Elteren test|||van Elteren test stratified by CGI-Severity score at baseline and testing between treatment differences in percentages based on non-missing responses within a timepoint. CGI-Severity score categorizes severity at baseline as normal,not at all ill, borderline mentally ill, mildly ill, moderately ill, markedly ill, severely ill, among the most extremely ill.||||0.0761
72548454|NCT00266409|144626406|SUPERIORITY_OR_OTHER|||||||0.0376||95.0|||||van Elteren test|||van Elteren test stratified by CGI-Severity score at baseline and testing between treatment differences in percentages based on non-missing responses within a timepoint. CGI-Severity score categorizes severity at baseline as normal,not at all ill, borderline mentally ill, mildly ill, moderately ill, markedly ill, severely ill, among the most extremely ill.||||0.0376
72582054|NCT01998919|144694750|SUPERIORITY_OR_OTHER|||||||0.0075|||||||Log Rank|||||||0.0075
72582055|NCT01998919|144694750|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.42||||0.0099|TWO_SIDED|95.0|0.22|0.81|||Wald test|||||0.81|0.22|0.0099
72582056|NCT01998919|144694751|SUPERIORITY_OR_OTHER|||||||0.0004|||||||Log Rank|||||||0.0004
72582057|NCT01998919|144694751|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.48||||0.0001|TWO_SIDED|95.0|0.33|0.7|||Wald Test|||||0.70|0.33|0.0001
72582058|NCT01998919|144694752|SUPERIORITY_OR_OTHER|||||||0.0001|||||||Log Rank|||||||0.0001
72548455|NCT00266409|144626407|SUPERIORITY_OR_OTHER|||||||0.1196||95.0|||||van Elteren test|||van Elteren test stratified by CGI-Severity score at baseline and testing between treatment differences in percentages based on non-missing responses within a timepoint. CGI-Severity score categorizes severity at baseline as normal,not at all ill, borderline mentally ill, mildly ill, moderately ill, markedly ill, severely ill, among the most extremely ill.||||0.1196
72582059|NCT01998919|144694752|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.47|||<|0.0001|TWO_SIDED|95.0|0.33|0.68|||Wald test|||||0.68|0.33|<0.0001
72582060|NCT01998919|144694753|SUPERIORITY_OR_OTHER|||||||0.5991|||||||Log Rank|||||||0.5991
72582061|NCT01998919|144694753|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.84||||0.3774|TWO_SIDED|95.0|0.58|1.23|||Wald test|||||1.23|0.58|0.3774
72582062|NCT00897715|144694756|SUPERIORITY_OR_OTHER_LEGACY|||||||0.03|TWO_SIDED|||||0.05 is the a priori threshold for statistical significance|ANCOVA|||For the primary specific aim, we will compare the mean percent change on hsCRP between the intervention arm and the placebo arm using linear regression. We anticipate that the intervention will conservatively decrease hsCRP by 54%; whereas, placebo will have no effect. Accordingly, we have estimated that we will need 24 subjects in the experimental arm and 24 controls to have an 80% power, with an alpha of 0.05 to detect the above mentioned effect size.||||0.03
72582063|NCT00897715|144694757|SUPERIORITY_OR_OTHER_LEGACY|||||||0.01|TWO_SIDED|||||0.05 is the a priori threshold for statistical significance|ANCOVA|||||||0.01
72582064|NCT02321111|144694758|OTHER|ANOVA||||||0.02|||||||ANOVA|||||||0.02
72582065|NCT00663793|144694821|NON_INFERIORITY_OR_EQUIVALENCE|A sample size of 8 per group was estimated to confer an 80% power to detect a 40% difference in testosterone AUC with a standard deviation of 20% at an alpha of 0.05|||||<|0.05|TWO_SIDED|95.0|||||Wilcoxon sign-rank|||||||<0.05
72412389|NCT00116805|144332790|SUPERIORITY_OR_OTHER||Difference in proportions|0.9|STANDARD_ERROR_OF_MEAN|2.6||0.733|TWO_SIDED|95.0|-4.2|5.9||P-value above corresponds to Z-test of the null hypothesis that stratum-adjusted difference is zero. Difference, standard error of the difference, and CI are stratum adjusted based on baseline ALT category (≤ 4 x ULN or \> 4 x ULN).|Z-test|||This information pertains to seroconversion to anti-HBs.||5.9|-4.2|0.733
72412390|NCT03320070|144332820|SUPERIORITY|||||||0.5076|||||||Chi-squared|||||||0.5076
72412391|NCT03320070|144332822|SUPERIORITY|||||||1|||||||Chi-squared|||||||1.0000
72412392|NCT03320070|144332824|SUPERIORITY|||||||0.0848|||||||Chi-squared|||||||0.0848
72412393|NCT03320070|144332826|SUPERIORITY|||||||0.2005|||||||Chi-squared|||||||0.2005
72412394|NCT03320070|144332828|SUPERIORITY|||||||0.9416|||||||Chi-squared|||||||0.9416
72412395|NCT03320070|144332830|SUPERIORITY|||||||0.1853|||||||Chi-squared|||||||0.1853
72412396|NCT04088097|144332838|SUPERIORITY|||||||0.01|||||||ANOVA|||||||.01
72412397|NCT04088097|144332839|SUPERIORITY|||||||0.75|||||||ANOVA|||||||.75
72412398|NCT04088097|144332840|SUPERIORITY|||||||0.03|||||||ANOVA|||||||.03
72412399|NCT03556761|144332846|SUPERIORITY||Risk Ratio (RR)|0.4||||0.03|TWO_SIDED|95.0|0.2|0.81|||Regression, Linear|||||0.81|0.20|0.03
72548456|NCT00266409|144626407|SUPERIORITY_OR_OTHER|||||||0.0029||95.0|||||van Elteren test|||van Elteren test stratified by CGI-Severity score at baseline and testing between treatment differences in percentages based on non-missing responses within a timepoint.CGI-Severity score categorizes severity at baseline as normal,not at all ill, borderline mentally ill, mildly ill, moderately ill, markedly ill, severely ill, among the most extremely ill.||||0.0029
72548457|NCT00266409|144626408|SUPERIORITY_OR_OTHER|||||||0.6323||95.0|||||van Elteren test|||van Elteren test stratified by CGI-Severity score at baseline and testing between treatment differences in percentages based on non-missing responses within a timepoint. CGI-Severity score categorizes severity at baseline as normal,not at all ill, borderline mentally ill, mildly ill, moderately ill, markedly ill, severely ill, among the most extremely ill.||||0.6323
72412400|NCT03556761|144332847|SUPERIORITY||Hazard Ratio (HR)|1.2||||0.12|TWO_SIDED|95.0|0.95|1.51|||Regression, Cox|||||1.51|0.95|0.12
72412401|NCT03556761|144332848|SUPERIORITY||Risk Ratio (RR)|0.55||||0.14|TWO_SIDED|95.0|0.25|1.21|||Chi-squared|||||1.21|0.25|0.14
72582066|NCT00663793|144694822|NON_INFERIORITY_OR_EQUIVALENCE|No power calculation was performed for this pilot study.|||||<|0.05||95.0|||||Wilcoxon sign-rank|||||||<0.05
72582067|NCT00663793|144694823|NON_INFERIORITY_OR_EQUIVALENCE|No power calculation was performed for this pilot study||||||0.05|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||Area-under-the-curve for serum estradiol||||0.05
72412402|NCT03556761|144332849|SUPERIORITY||Risk Ratio (RR)|0.87||||0.36|TWO_SIDED|95.0|0.64|1.18|||Chi-squared|||||1.18|0.64|0.36
72412403|NCT03556761|144332850|SUPERIORITY||Risk Ratio (RR)|0.02||||0.76|TWO_SIDED|95.0|-0.09|0.13|||Regression, Linear|||||.13|-0.09|0.76
72412404|NCT03556761|144332851|SUPERIORITY|||||||0.62|||||||Fisher Exact|||||||0.62
72412405|NCT03556761|144332852|SUPERIORITY||Risk Ratio (RR)|3.0|||||TWO_SIDED|95.0|0.32|28.59||||||||28.59|0.32|
72412406|NCT03556761|144332853|SUPERIORITY||Risk Ratio (RR)|0.61||||0.03|TWO_SIDED|95.0|0.39|0.96|||Chi-squared|||||0.96|0.39|0.03
72412407|NCT00693992|144332854|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.62||||0.0006|TWO_SIDED|95.0|0.47|0.82|||Log Rank|||||0.82|0.47|0.0006
72412408|NCT00693992|144332855|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.98||||0.89|TWO_SIDED|95.0|0.73|1.31|||Log Rank|||||1.31|0.73|0.89
72412409|NCT00693992|144332857|SUPERIORITY|||||||0.0061|||||||Fisher Exact|||||||0.0061
72412410|NCT00693992|144332858|SUPERIORITY|||||||0.8393|||||||Fisher Exact|||||||0.8393
72412411|NCT01303627|144332871|SUPERIORITY_OR_OTHER||||||<|0.05||95.0||||Statistical analyses were performed x2 test or Mann Whitney U test as approriate. A p value of \<0.05 was considered statistically significant.|Chi-squared|||The incidence of complications on removal of the cLMA has been reported 54 % in awake patients group A power analysis indicated that a minimum 16 patients in each group were required to demonstrate a difference that 50% reduction the complications (a power of 80% and α error 0.05).||||<0.05
72412412|NCT01054820|144332879|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-value is unadjusted. All statistical tests were 2-sided and employed a level of significance of alpha = 0.05.|t-test, 2 sided|||Null hypothesis: no change from baseline. Study powered at 95 percent (%) to detect a mean change of at least 1.2 units, with assumed standard deviation of at most 3.2 units.||||<0.0001
72412413|NCT01054820|144332880|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-value is unadjusted. All statistical tests were 2-sided and employed a level of significance of alpha = 0.05.|McNemar|||||||<0.0001
72412414|NCT01054820|144332881|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-value is unadjusted. All statistical tests were 2-sided and employed a level of significance of alpha = 0.05.|t-test, 2 sided|||||||<0.0001
72412415|NCT01054820|144332882|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-value is unadjusted. All statistical tests were 2-sided and employed a level of significance of alpha = 0.05.|t-test, 2 sided|||||||<0.0001
72412416|NCT01054820|144332883|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-value is unadjusted. All statistical tests were 2-sided and employed a level of significance of alpha = 0.05.|t-test, 2 sided|||||||<0.0001
72412417|NCT01054820|144332884|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-value is unadjusted. All statistical tests were 2-sided and employed a level of significance of alpha = 0.05.|t-test, 2 sided|||||||<0.0001
72412418|NCT01054820|144332887|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-value is unadjusted. All statistical tests were 2-sided and employed a level of significance of alpha = 0.05.|t-test, 2 sided|||||||<0.0001
72412419|NCT01154166|144332890|SUPERIORITY_OR_OTHER||Adjusted mean for treatment difference|-1.76|||<|0.001|TWO_SIDED|95.0|-2.27|-1.26|||ANCOVA||The estimated value indicates the treatment difference for the adjusted mean for Ropinirole PR and placebo.|||-1.26|-2.27|<0.001
72412420|NCT00996996|144332903|SUPERIORITY_OR_OTHER||Percentage of participants|95.0|||||TWO_SIDED|95.0|90.0|100.0|||||The estimated value represents the percentage of participants with a confirmed response.|||100|90|
72412421|NCT00996996|144332904|SUPERIORITY_OR_OTHER||Percentage of participants|97.0|||||TWO_SIDED|95.0|94.0|100.0|||||The estimated value represents the percentage of participants with a response.|||100|94|
72412422|NCT00996996|144332905|SUPERIORITY_OR_OTHER||Percentage of participants|70.0|||||TWO_SIDED|95.0|59.0|80.0|||||The estimated value represents the percentage of participants with a confirmed CR.|||80|59|
72412423|NCT00996996|144332905|SUPERIORITY_OR_OTHER||Percentage of participants|3.0|||||TWO_SIDED|95.0|0.0|6.0|||||The estimated value represents the percentage of participants with a confirmed CCR.|||6|0|
72412424|NCT00996996|144332905|SUPERIORITY_OR_OTHER||Percentage of participants|75.0|||||TWO_SIDED|95.0|65.0|85.0|||||The estimated value represents the percentage of participants with confirmed CR + confirmed CCR.|||85|65|
72412425|NCT00996996|144332905|SUPERIORITY_OR_OTHER||Percentage of participants|17.0|||||TWO_SIDED|95.0|9.0|26.0|||||The estimated value represents the percentage of participants with a confirmed PR.|||26|9|
72412426|NCT00996996|144332906|SUPERIORITY_OR_OTHER||Percentage of participants|74.0|||||TWO_SIDED|95.0|64.0|84.0|||||The estimated value represents the percentage of participants with a CR.|||84|64|
72412427|NCT00996996|144332906|SUPERIORITY_OR_OTHER||Percentage of participants|4.0|||||TWO_SIDED|95.0|0.0|8.0|||||The estimated value represents the percentage of participants with a CCR.|||8|0|
72412428|NCT00996996|144332906|SUPERIORITY_OR_OTHER||Percentage of participants|78.0|||||TWO_SIDED|95.0|68.0|87.0|||||The estimated value represents the percentage of participants with a CR + CCR.|||87|68|
72412429|NCT00996996|144332906|SUPERIORITY_OR_OTHER||Percentage of participants|20.0|||||TWO_SIDED|95.0|11.0|29.0|||||The estimated value represents the percentage of participants with a PR.|||29|11|
72412430|NCT01175382|144332971|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||Analysis of Covariance used to compare mean changes from baseline to 6 weeks among groups adjusting for baseline values and age. Last Observation Carried Forward was used for imputation of missing data.||||<.0001
72412431|NCT01175382|144332972|SUPERIORITY_OR_OTHER|||||||0.0013|||||||ANCOVA|||Analysis of Covariance to test for differences in mean change from 6 weeks to 12 weeks in voiding frequency controlling for age and 6 week frequency. Last Observation Carried Forward was used to impute missing data.||||.0013
72412432|NCT01175382|144332973|SUPERIORITY_OR_OTHER|||||||0.2933|||||||ANCOVA|||Analysis of Covariance testing whether mean change in 24-hour voiding frequency differed among the groups after adjusting for baseline voiding frequency and age. Last Observation Carried Forward was used to impute missing data.||||0.2933
72582068|NCT02550561|144694844|SUPERIORITY|||||||0.317||||||Subjects that reported either moderately or markedly improved on the GRA scale at 6 weeks compared to 12 weeks.|McNemar|||||||0.317
72412433|NCT01175382|144332974|SUPERIORITY_OR_OTHER|||||||0.0051|||||||ANCOVA|||Analysis of Covariance used to test means changes among the groups adjusting for baseline values and age. Last Observation Carried Forward was used to impute missing data.||||0.0051
72412434|NCT01175382|144332975|SUPERIORITY_OR_OTHER|||||||0.1402|||||||ANCOVA|||Analysis of Covariance comparing mean change score among groups controlling for age and baseline score||||.1402
72412435|NCT01175382|144332976|SUPERIORITY_OR_OTHER|||||||0.0015|||||||ANCOVA|||Analysis of Covariance comparing mean change in Nocturia among groups adjusting for baseline values of nocturia and age. Last Observation Carried Forward was used to impute missing data.||||0.0015
72412436|NCT01175382|144332977|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|||Analysis of Covariance comparing mean change in Overactive Bladder Questionnaire from baseline to 6 weeks among groups after controlling for baseline value and age. Last Observation Carried Forward was used to impute missing data.||||<.0001
72412437|NCT01175382|144332978|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|||"Analysis of Covariance comparing mean chance in IPSS from baseline to 6 weeks among groups controlling for baseline IPSS values and age.~Last Observation Carried Forward was used to impute missing data."||||<.0001
72412438|NCT01175382|144332979|SUPERIORITY_OR_OTHER|||||||0.0022|||||||Cochran-Mantel-Haenszel|||||||0.0022
72582069|NCT02550561|144694845|OTHER|||||||0.47|||||||paired t-tests|||The mean change in Visual Analog Scale (VAS) score for bladder pain||||0.47
72582070|NCT02550561|144694845|OTHER|||||||0.17|||||||paired t-test|||The mean change in Pelvis Pain and Urgency/Frequency Patient Symptom (PUF) score||||0.17
72582071|NCT02550561|144694845|OTHER|||||||0.08|||||||paired t-test|||The mean change for O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI)||||.08
72582072|NCT02550561|144694845|OTHER|||||||0.51|||||||paired t-test|||The mean change O'Leary-Sant Interstitial Cystitis Problem Index (ICPI)||||0.51
72412439|NCT01175382|144332980|SUPERIORITY_OR_OTHER|||||||0.0222|||||||Cochran-Mantel-Haenszel|||||||.0222
72412440|NCT01175382|144332981|SUPERIORITY_OR_OTHER|||||||0.0217|||||||Cochran-Mantel-Haenszel|||||||.0217
72412441|NCT01175382|144332982|SUPERIORITY_OR_OTHER|||||||0.669|||||||ANCOVA|||Analysis of Covariance used to test whether mean changes in Urgency Score from 6 weeks to 12 weeks differed among groups after controlling for age and 6 week Urgency Score. Last Observation Carried Forward was used to impute missing values.||||0.6690
72412442|NCT01175382|144332983|SUPERIORITY_OR_OTHER|||||||0.0812|||||||ANCOVA|||Analysis of Covariance to test whether mean change in Incontinence Episodes from 6 weeks to 12 weeks differed among groups after controlling for age and frequency of incontinence episodes at 6 weeks. Last Observation Carried Forward was used to impute missing values.||||0.0812
72412443|NCT01175382|144332984|SUPERIORITY_OR_OTHER|||||||0.5578|||||||ANCOVA|||Analysis of Covariance used to test whether mean changes in nocturia from 6 weeks to 12 weeks differed among groups after controlling for age and 6 week nocturia frequency. Last Observation Carried Forward was used to impute missing values.||||0.5578
72412444|NCT01175382|144332985|SUPERIORITY_OR_OTHER|||||||0.0279|||||||ANCOVA|||Analysis of Covariance to test whether mean change in Overactive Bladder Questionnaire (OAB-q) from 6 to 12 weeks differed among groups after controlling for age and 6 week OAB-q score. Last Observation Carried Forward was used to impute missing values.||||0.0279
72412445|NCT01175382|144332986|SUPERIORITY_OR_OTHER|||||||0.2553|||||||ANCOVA|||Analysis of Covariance to test whether mean change in the International Prostate Symptom Scale (IPSS) from 6 to 12 weeks differed among groups||||0.2553
72412446|NCT01175382|144332987|SUPERIORITY_OR_OTHER|||||||0.3165|||||||Cochran-Mantel-Haenszel|||||||0.3165
72412447|NCT01175382|144332988|SUPERIORITY_OR_OTHER|||||||0.8153|||||||Cochran-Mantel-Haenszel|||||||0.8153
72412448|NCT01175382|144332989|SUPERIORITY_OR_OTHER|||||||0.5536|||||||Cochran-Mantel-Haenszel|||||||0.5536
72412449|NCT01175382|144332990|SUPERIORITY_OR_OTHER|||||||0.2035|||||||ANCOVA|||Analysis of Covariance testing whether mean change in Nocturia frequency differed among the groups after adjusting for baseline Nocturia frequency and age. Last Observation Carried Forward was used to impute missing data||||0.2035
72412450|NCT01175382|144332991|SUPERIORITY_OR_OTHER|||||||0.0549|||||||ANCOVA|||Analysis of Covariance testing whether mean change in Urgency Score differed among the groups after adjusting for Urgency Scoe and age. Last Observation Carried Forward was used to impute missing data||||.0549
72412451|NCT01175382|144332992|SUPERIORITY_OR_OTHER|||||||0.507|||||||ANCOVA|||Analysis of Covariance testing whether mean change in Incontinent Episodes differed among the groups after adjusting for baseline Incontinent episodes frequency and age. Last Observation Carried Forward was used to impute missing data||||0.5070
72412452|NCT01175382|144332993|SUPERIORITY_OR_OTHER|||||||0.0529|||||||ANCOVA|||Analysis of Covariance testing whether mean change in Overactive Bladder Questionnaire differed among the groups after adjusting for baseline Overactive Bladder Questionnaire Score and age. Last Observation Carried Forward was used to impute missing data||||.0529
72412453|NCT01175382|144332994|SUPERIORITY_OR_OTHER|||||||0.2384|||||||ANCOVA|||Analysis of Covariance to test whether mean change in International Prostate Symptom Score from Baseline to 12 weeks differed among groups after controlling for baseline International Prostate Symptom Score and age. Last Observation Carried Forward was used to impute missing values.||||0.2384
72412454|NCT02203019|144333025|EQUIVALENCE|Outcome comparison used the Mann Whitney U test||||||0.107|||||||Wilcoxon (Mann-Whitney)|||||||0.107
72412455|NCT02203019|144333026|EQUIVALENCE|Outcomes were compared using a Mann Whitney U test.||||||0.26|||||||Wilcoxon (Mann-Whitney)|||||||0.260
72412456|NCT02203019|144333027|EQUIVALENCE|Outcomes were compared using a Mann Whitney U test.||||||0.376|||||||Wilcoxon (Mann-Whitney)|||||||0.376
72412457|NCT02203019|144333028|EQUIVALENCE|Outcomes were compared using a Chi square test.||||||0.739|||||||Chi-squared|||||||0.739
72412458|NCT02031276|144333029|OTHER||difference in percentage of participants|12.6||||0.0955|TWO_SIDED|95.0|-2.2|27.5|||Cochran-Mantel-Haenszel|||Statistics for the difference are calculated using the Cochran-Mantel-Haenszel risk difference stratified by anti-tumor necrosis factor (anti-TNF) exposure.||27.5|-2.2|0.0955
72412459|NCT02031276|144333030|OTHER||difference in percentage of participants|13.4||||0.1151|TWO_SIDED|95.0|-3.3|30.1|||Cochran-Mantel-Haenszel|||Statistics for the difference are calculated using the Cochran-Mantel-Haenszel risk difference stratified by anti-TNF exposure.||30.1|-3.3|0.1151
72412460|NCT02031276|144333031|OTHER||difference in percentage of participants|12.0||||0.0057|TWO_SIDED|95.0|3.5|20.6|||Cochran-Mantel-Haenszel|||Statistics for the difference are calculated using the Cochran-Mantel-Haenszel risk difference stratified by anti-TNF exposure.||20.6|3.5|0.0057
72548458|NCT00266409|144626408|SUPERIORITY_OR_OTHER|||||||0.5533||95.0|||||van Elteren test|||van Elteren test stratified by CGI-Severity score at baseline and testing between treatment differences in percentages based on non-missing responses within a timepoint. CGI-Severity score categorizes severity at baseline as normal,not at all ill, borderline mentally ill, mildly ill, moderately ill, markedly ill, severely ill, among the most extremely ill.||||0.5533
72412461|NCT02031276|144333032|OTHER||difference in percentage of participants|18.7||||0.0104|TWO_SIDED|95.0|4.4|33.0|||Cochran-Mantel-Haenszel|||Statistics for the difference are calculated using the Cochran-Mantel-Haenszel risk difference stratified by anti-TNF exposure.||33.0|4.4|0.0104
72412462|NCT02031276|144333033|OTHER||difference in percentage of participants|2.4||||0.4977|TWO_SIDED|95.0|-4.5|9.2|||Cochran-Mantel-Haenszel|||Statistics for the difference are calculated using the Cochran-Mantel-Haenszel risk difference stratified by anti-TNF exposure.||9.2|-4.5|0.4977
72412463|NCT02031276|144333034|OTHER||difference in percentage of participants|7.4||||0.0107|TWO_SIDED|95.0|1.7|13.0|||Cochran-Mantel-Haenszel|||Statistics for the difference are calculated using the Cochran-Mantel-Haenszel risk difference stratified by anti-TNF exposure.||13.0|1.7|0.0107
72412464|NCT01148810|144333035|SUPERIORITY_OR_OTHER||Bayesian analysis|0.96|||||||||||||||Probability that the difference (BAF312-Placebo) is greater than the threshold|||
72412465|NCT02509624|144333046|OTHER||%Geometric least-square mean(GLSM) ratio|105.08|||||TWO_SIDED|90.0|77.08|143.23||||||AUCinf of selonsertib||143.23|77.08|
72412466|NCT02509624|144333046|OTHER||% GLSM ratio|142.65|||||TWO_SIDED|90.0|120.52|168.84||||||AUCinf of selonsertib||168.84|120.52|
72412467|NCT02509624|144333046|OTHER||% GLSM ratio|110.55|||||TWO_SIDED|90.0|86.99|140.49||||||AUCinf of selonsertib||140.49|86.99|
72412468|NCT02509624|144333046|OTHER||% GLSM ratio|62.05|||||TWO_SIDED|90.0|43.84|87.81||||||AUCinf of GS-607509||87.81|43.84|
72412469|NCT02509624|144333046|OTHER||% GLSM ratio|66.44|||||TWO_SIDED|90.0|36.72|120.21||||||AUCinf of GS-607509||120.21|36.72|
72412470|NCT02509624|144333046|OTHER||% GLSM ratio|103.46|||||TWO_SIDED|90.0|51.75|206.83||||||AUCinf of GS-607509||206.83|51.75|
72548459|NCT00266409|144626409|SUPERIORITY_OR_OTHER|||||||0.1705||95.0|||||van Elteren test|||van Elteren test stratified by CGI-Severity score at baseline and testing between treatment differences in percentages based on non-missing responses within a timepoint. CGI-Severity score categorizes severity at baseline as normal,not at all ill, borderline mentally ill, mildly ill, moderately ill, markedly ill, severely ill, among the most extremely ill.||||0.1705
72412471|NCT02509624|144333047|OTHER||% GLSM ratio|99.87|||||TWO_SIDED|90.0|73.38|135.92||||||AUClast of selonsertib||135.92|73.38|
72412472|NCT02509624|144333047|OTHER||% GLSM ratio|141.75|||||TWO_SIDED|90.0|118.5|169.55||||||AUClast of selonsertib||169.55|118.50|
72412473|NCT02509624|144333047|OTHER||% GLSM ratio|112.24|||||TWO_SIDED|90.0|87.69|143.65||||||AUClast of selonsertib||143.65|87.69|
72412474|NCT02509624|144333047|OTHER||% GLSM ratio|61.2|||||TWO_SIDED|90.0|43.06|86.98||||||AUClast of GS-607509||86.98|43.06|
72412475|NCT02509624|144333047|OTHER||% GLSM ratio|61.07|||||TWO_SIDED|90.0|33.62|110.91||||||AUClast of GS-607509||110.91|33.62|
72412476|NCT02509624|144333047|OTHER||% GLSM ratio|96.13|||||TWO_SIDED|90.0|48.47|190.67||||||AUClast of GS-607509||190.67|48.47|
72412477|NCT02509624|144333048|OTHER||% GLSM ratio|88.68|||||TWO_SIDED|90.0|74.83|105.1||||||Cmax of selonsertib||105.10|74.83|
72412478|NCT02509624|144333048|OTHER||% GLSM ratio|91.16|||||TWO_SIDED|90.0|78.76|105.52||||||Cmax of selonsertib||105.52|78.76|
72412479|NCT02509624|144333048|OTHER||% GLSM ratio|100.19|||||TWO_SIDED|90.0|83.73|119.88||||||Cmax of selonsertib||119.88|83.73|
72412480|NCT02509624|144333048|OTHER||% GLSM ratio|71.44|||||TWO_SIDED|90.0|54.58|93.5||||||Cmax of GS-607509||93.50|54.58|
72412481|NCT02509624|144333048|OTHER||% GLSM ratio|46.92|||||TWO_SIDED|90.0|32.59|67.54||||||Cmax of GS-607509||67.54|32.59|
72412482|NCT02509624|144333048|OTHER||% GLSM ratio|93.93|||||TWO_SIDED|90.0|67.6|130.5||||||Cmax of GS-607509||130.50|67.60|
72412483|NCT00736996|144333093|SUPERIORITY_OR_OTHER||||||<|0.0125|TWO_SIDED|||||Statistical significance was defined as a 2-sided p-value \< 0.0125 (=0.05/4) to adjust for multiple comparisons.|Regression, Linear|||The mean change in domain score with PIO was compared with the mean change in domain score with Placebo in a linear regression conditioned on the stratification categories (MCI subtype and number of APOE ε4 alleles) and the baseline domain score.||||<0.0125
72412484|NCT00736996|144333093|SUPERIORITY_OR_OTHER||||||<|0.0125|TWO_SIDED|||||Statistical significance was defined as a 2-sided p-value \< 0.0125 (=0.05/4) to adjust for multiple comparisons.|Regression, Linear|||The mean change in domain score with EET was compared with the mean change in domain score with Placebo in a linear regression conditioned on the stratification categories (MCI subtype and number of APOE ε4 alleles) and the baseline domain score.||||<0.0125
72412485|NCT00736996|144333094|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Regression, Linear|||The mean change with PIO was compared with the mean change with Placebo in a linear regression conditioned on the stratification categories (MCI subtype and number of APOE ε4 alleles) and the baseline level of the outcome variable.||||<0.05
72412486|NCT00736996|144333094|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Regression, Linear|||The mean change with EET was compared with the mean change with Placebo in a linear regression conditioned on the stratification categories (MCI subtype and number of APOE ε4 alleles) and the baseline level of the outcome variable.||||<0.05
72412487|NCT00736996|144333095|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Regression, Linear|||The mean change with PIO was compared with the mean change with Placebo in a linear regression conditioned on the stratification categories (MCI subtype and number of APOE ε4 alleles) and the baseline level of the outcome variable.||||<0.05
72582073|NCT02550561|144694845|OTHER|||||||0.22|||||||paired t-test|||The mean change in 24-h urinary frequency||||0.22
72412488|NCT00736996|144333095|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Regression, Linear|||The mean change with EET was compared with the mean change with Placebo in a linear regression conditioned on the stratification categories (MCI subtype and number of APOE ε4 alleles) and the baseline level of the outcome variable.||||<0.05
72412489|NCT01255358|144333098|OTHER|Changes from baseline (V1) at V2, V4 and V7 were analyzed with a RMANOVA design with age and ICARS at baseline as covariates. A Wilcoxon non-parametric test between visits was performed when the overall analysis was significant in order to help determine timing of effects|Mean Difference (Final Values)|-4.0|STANDARD_DEVIATION|7.5||0.02|TWO_SIDED|95.0|-7.1|-0.9|||Wilcoxon (Mann-Whitney)|||The primary analysis on ICARS Total score has been conducted on the ITT Population employing carry-forward and carry-backward procedures for missing data imputation, in order to evaluate all enrolled patients.||-0.9|-7.1|0.02
72412490|NCT01255358|144333099|OTHER|Changes from baseline (V1) at V2, V4 and V7 were analyzed with a RMANOVA design with age and ICARS at baseline as covariates. A Wilcoxon non-parametric test between visits was performed when the overall analysis was significant in order to help determine timing of effects|Mean Difference (Final Values)|-5.2|STANDARD_DEVIATION|7.0||0.0031|TWO_SIDED|95.0|-8.4|-2.0|||Wilcoxon (Mann-Whitney)|||Overall analysis on the PP Population||-2|-8.4|0.0031
72412491|NCT01255358|144333104|OTHER|VABS Total score and subscales have been analyzed with a RMANOVA design, using age as covariate (dichotomized as Low- or High-, using median age as threshold).|Median Difference (Final Values)|1.3|STANDARD_DEVIATION|1.2|<|0.0001|TWO_SIDED|95.0|0.8|1.8|||Wilcoxon (Mann-Whitney)|||VABS total score at V7||1.8|0.8|<0.0001
72412492|NCT01255358|144333105|OTHER||Mean Difference (Final Values)|1.5|STANDARD_DEVIATION|1.1|<|0.0001|TWO_SIDED|95.0|1.0|2.0|||Wilcoxon (Mann-Whitney)|||||2|1|<0.0001
72412493|NCT03029208|144333139|NON_INFERIORITY|Non-inferiority was to be established if the lower limit of the two-sided 95% CI for the treatment difference was greater than the pre-specified non-inferiority margin of -0.75 g/dL.|Least square (LS) mean difference|-0.1|||||TWO_SIDED|95.0|-0.34|0.14|||||An ANCOVA model including randomization stratification factors Baseline Hgb and treatment was performed to obtain a point estimate and two-sided 95% CI for the treatment difference (daprodustat-darbepoetin alfa).|||0.14|-0.34|
72582074|NCT00791778|144694850|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.09||||0.655|TWO_SIDED|95.0|0.72|1.63|||Log Rank|Two treatment groups compared using a log-rank test with one-sided alpha of 0.10 stratified by the same factors as randomization|Sorafenib compared to Placebo|Sample size based on the primary efficacy endpoint of PFS. Clinically meaningful improvement defined as 65% increase in median PFS. With one-sided alpha of 0.10, power of 90% and a randomization ratio of 1:1 between Sorafenib and Placebo, a total of 105 PFS events were required.||1.63|0.72|0.655
72582075|NCT00791778|144694851|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.43||||0.951|TWO_SIDED|95.0|0.93|2.2|||Log Rank|Two treatment groups compared using a log-rank test with one-sided alpha of 0.10 stratified by the same factors as randomization|Sorafenib compared to Placebo|||2.20|0.93|0.951
72582076|NCT00791778|144694852|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.49||||0.84|TWO_SIDED|95.0|0.69|3.23|||Log Rank|Two treatment groups compared using a log-rank test with one-sided alpha of 0.10 stratified by the same factors as randomization.|Sorafenib compared to Placebo|||3.23|0.69|0.84
72582077|NCT00235755|144694876|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Non-parametric rank analysis of covariance adjusted for baseline 28-seizure frequency and stratified by baseline seizure frequency category and region|Non-parametric rank ANCOVA|||||||<0.001
72582078|NCT00235755|144694876|SUPERIORITY_OR_OTHER|||||||0.007||95.0||||Non-parametric rank analysis of covariance adjusted for baseline 28-seizure frequency and stratified by baseline seizure frequency category and region|Non-parametric rank ANCOVA|||||||0.007
72582079|NCT00235755|144694877|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Fisher Exact|||||||<0.001
72582080|NCT00235755|144694877|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Fisher Exact|||||||<0.001
72548460|NCT00266409|144626409|SUPERIORITY_OR_OTHER|||||||0.3196||95.0|||||van Elteren test|||van Elteren test stratified by CGI-Severity score at baseline and testing between treatment differences in percentages based on non-missing responses within a timepoint. CGI-Severity score categorizes severity at baseline as normal,not at all ill, borderline mentally ill, mildly ill, moderately ill, markedly ill, severely ill, among the most extremely ill.||||0.3196
72548461|NCT00266409|144626410|SUPERIORITY_OR_OTHER|||||||0.0419||95.0|||||van Elteren test|||van Elteren test stratified by CGI-Severity score at baseline and testing between treatment differences in percentages based on non-missing responses within a timepoint. CGI-Severity score categorizes severity at baseline as normal,not at all ill, borderline mentally ill, mildly ill, moderately ill, markedly ill, severely ill, among the most extremely ill.||||0.0419
72548462|NCT00266409|144626410|SUPERIORITY_OR_OTHER|||||||0.2541||95.0|||||van Elteren test|||van Elteren test stratified by CGI-Severity score at baseline and testing between treatment differences in percentages based on non-missing responses within a timepoint. CGI-Severity score categorizes severity at baseline as normal,not at all ill, borderline mentally ill, mildly ill, moderately ill, markedly ill, severely ill, among the most extremely ill.||||0.2541
72582081|NCT01532934|144694899|SUPERIORITY_OR_OTHER|||||||0.02||||||As stated, the p-value reflects the Factor 1 by treatment interaction term and its effect on percent days abstinent/month.|Regression, Linear|||A priori hypothesis. Psychopathy Factor 1 (F1) X treatment interaction to predict higher substance use among people high in F1 + who get treatment relative to individuals with high F1 who get standard care.||||.02
72582082|NCT01532934|144694900|SUPERIORITY_OR_OTHER|||||||0.34||||||As stated, the p-value reflects the F1 X treatment interaction term and its effect on substance use consequences. A priori threshold for significance was p\<.05.|Regression, Linear|||Experimental hypothesis: The F1 X treatment interaction will show that individuals low on F1 who get treatment will reduce substance use consequences at six months relative to those low on F1 who get standard care.||||.34
72582083|NCT01532934|144694901|SUPERIORITY_OR_OTHER|||||||0.69||||||a priori threshold p\<.05|Regression, Logistic|||Experimental hypothesis: Treatment X F1 interaction will predict fewer charges at one-year follow-up for individuals low on F1 who got treatment relative to individuals low on F1 who did not.||||.69
72582084|NCT00725920|144694917|SUPERIORITY_OR_OTHER|||||||0.0076||95.0|||||t-test, 2 sided|||||||0.0076
72582085|NCT02218463|144694973|SUPERIORITY|||||||0.206|||||||Fisher Exact|||Assessment of complete resolution between the 2 study arms.||||0.206
72582086|NCT02218463|144694974|SUPERIORITY|||||||0.0001|||||||ANOVA|||Time Effect||||0.0001
72582087|NCT02218463|144694974|SUPERIORITY|||||||0.37|||||||ANOVA|||Treatment Effect||||0.370
72582088|NCT02218463|144694974|SUPERIORITY|||||||0.425|||||||ANOVA|||Treatment by time interaction||||0.425
72582089|NCT02513160|144694975|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|150.0|||<|0.0001|TWO_SIDED|95.0|86.8|213.2||a priori threshold for significance of 0.05.|ANCOVA|Difference of LS means, 95% CI, and p-value represent ANCOVA results adjusted for baseline, sex, age, current asthma therapy, and treatment.|Active - placebo|A fixed-sequence multiple testing procedure was implemented to interpret the results from the primary analysis while controlling the family-wise error rate at 5%. The 640-mcg/day BAI dose was tested first. If the comparison to placebo resulted in p≤0.05, the 320-mcg/day BAI dose was then tested.||213.2|86.8|<0.0001
72582090|NCT02513160|144694975|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|144.0|||<|0.0001|TWO_SIDED|95.0|80.7|206.6||a priori threshold for significance of 0.05.|ANCOVA|Difference of LS means, 95% CI, and p-value represent ANCOVA results adjusted for baseline, sex, age, current asthma therapy, and treatment.|Active - placebo|A fixed-sequence multiple testing procedure was implemented to interpret the results from the primary analysis while controlling the family-wise error rate at 5%. The 640-mcg/day BAI dose was tested first. If the comparison to placebo resulted in p≤0.05, the 320-mcg/day BAI dose was then tested.||206.6|80.7|<0.0001
72582091|NCT02513160|144694975|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|148.0|||<|0.0001|TWO_SIDED|95.0|84.7|211.4||a priori threshold for significance of 0.05. The p-value was not adjusted.|ANCOVA|Difference of LS means and 95% CI represent ANCOVA results adjusted for baseline, sex, age, current asthma therapy, and treatment.|Active - placebo|||211.4|84.7|<0.0001
72582092|NCT02513160|144694976|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|21.9||||0.0003|TWO_SIDED|95.0|10.11|33.71||a priori threshold for significance of 0.05.|mixed model for repeated measures|MMRM analysis with covariates for baseline, sex, age, current asthma therapy, treatment, week, and treatment by week interaction.|Active - placebo|Treatment comparisons began with am PEF for BAI 640 mcg/day vs placebo. If the p-value was ≤0.05, the next comparisons of interest were made 1) the next secondary outcome comparison for BAI 640 mcg/day vs placebo 2) the am PEF for BAI 320 mcg/day vs placebo. This procedure allowed for control of the Type I error for comparisons at a particular BAI treatment over the 5 secondary endpoints, as well as comparisons within an endpoint. It did not control the overall Type I error.||33.71|10.11|0.0003
72582093|NCT02513160|144694976|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|30.1|||<|0.0001|TWO_SIDED|95.0|18.33|41.9||a priori threshold for significance of 0.05.|mixed model for repeated measures|MMRM analysis with covariates for baseline, sex, age, current asthma therapy, treatment, week, and treatment by week interaction.|Active - placebo|Sequential order of analyses described in previous analysis.||41.90|18.33|<0.0001
72582094|NCT02513160|144694976|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|21.0||||0.0006|TWO_SIDED|95.0|9.14|32.83||a priori threshold for significance of 0.05.|mixed model for repeated measures|MMRM analysis with covariates for baseline, sex, age, current asthma therapy, treatment, week, and treatment by week interaction.|Active - placebo|Comparisons for MDI dose versus placebo for the secondary efficacy endpoints were used for assay sensitivity.||32.83|9.14|0.0006
72548463|NCT00266409|144626411|SUPERIORITY_OR_OTHER|||||||0.0677||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAM-A insomnia subscore as a covariate|ANCOVA|||||||0.0677
72548464|NCT00266409|144626411|SUPERIORITY_OR_OTHER|||||||0.0273||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAM-A insomnia subscore as a covariate|ANCOVA|||||||0.0273
72548465|NCT00266409|144626412|SUPERIORITY_OR_OTHER|||||||0.5153||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAM-A insomnia subscore as a covariate|ANCOVA|||||||0.5153
72548466|NCT00266409|144626412|SUPERIORITY_OR_OTHER|||||||0.0122||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAM-A insomnia subscore as a covariate|ANCOVA|||||||0.0122
72548467|NCT00266409|144626413|SUPERIORITY_OR_OTHER|||||||0.4648||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAM-A insomnia subscore as a covariate|ANCOVA|||||||0.4648
72548468|NCT00266409|144626413|SUPERIORITY_OR_OTHER|||||||0.5502||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAM-A insomnia subscore as a covariate|ANCOVA|||||||0.5502
72548469|NCT00266409|144626414|SUPERIORITY_OR_OTHER|||||||0.9093||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAM-A insomnia subscore as a covariate|ANCOVA|||||||0.9093
72548470|NCT00266409|144626414|SUPERIORITY_OR_OTHER|||||||0.1354||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAM-A insomnia subscore as a covariate|ANCOVA|||||||0.1354
72548471|NCT00266409|144626415|SUPERIORITY_OR_OTHER|||||||0.7434||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAM-A insomnia subscore as a covariate|ANCOVA|||||||0.7434
72582095|NCT02513160|144694977|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|143.0|||<|0.0001|TWO_SIDED|95.0|71.7|214.1||a priori threshold for significance of 0.05.|mixed model for repeated measures|MMRM analysis with covariates for baseline, sex, age, current asthma therapy, treatment, week, and treatment by week interaction.|Active - placebo|Sequential order of analyses described in Outcome #2, analysis #1.||214.1|71.7|<0.0001
72582096|NCT02513160|144694977|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|170.0|||<|0.0001|TWO_SIDED|95.0|98.5|240.5||a priori threshold for significance of 0.05.|mixed model for repeated measures|MMRM analysis with covariates for baseline, sex, age, current asthma therapy, treatment, week, and treatment by week interaction.|Active - placebo|Sequential order of analyses described in Outcome #2, analysis #1.||240.5|98.5|<0.0001
72582097|NCT02513160|144694977|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|133.0||||0.0003|TWO_SIDED|95.0|61.3|204.3||a priori threshold for significance of 0.05.|mixed model for repeated measures|MMRM analysis with covariates for baseline, sex, age, current asthma therapy, treatment, week, and treatment by week interaction.|Active - placebo|Comparisons for MDI dose versus placebo for the secondary efficacy endpoints were used for assay sensitivity.||204.3|61.3|0.0003
72412494|NCT03029208|144333140|SUPERIORITY||LS mean difference|19.4||||0.8949|TWO_SIDED|95.0|-11.0|49.9|||ANCOVA||An ANCOVA model was used to compare the difference in this average monthly IV iron dose between arms, including factors for Baseline dose, treatment and the randomization stratification factors.|||49.9|-11.0|0.8949
72582098|NCT02513160|144694978|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|-1.02|||<|0.0001|TWO_SIDED|95.0|-1.408|-0.64||a priori threshold for significance of 0.05.|mixed model for repeated measures|MMRM analysis with covariates for baseline, sex, age, current asthma therapy, treatment, week, and treatment by week interaction.|Active - placebo|Sequential order of analyses described in Outcome #2, analysis #1.||-0.640|-1.408|<0.0001
72548472|NCT00266409|144626415|SUPERIORITY_OR_OTHER|||||||0.1148||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAM-A insomnia subscore as a covariate|ANCOVA|||||||0.1148
72548473|NCT00266409|144626416|SUPERIORITY_OR_OTHER|||||||0.9346||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAMA-A insomnia subscore as a covariate|ANCOVA|||||||0.9346
72548474|NCT00266409|144626416|SUPERIORITY_OR_OTHER|||||||0.2709||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAM-A insomnia subscore as a covariate|ANCOVA|||||||0.2709
72548475|NCT00266409|144626417|SUPERIORITY_OR_OTHER|||||||0.3827||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAM-A insomnia subscore as a covariate|ANCOVA|||||||0.3827
72548476|NCT00266409|144626417|SUPERIORITY_OR_OTHER|||||||0.2513||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAM-A insomnia subscore as a covariate|ANCOVA|||||||0.2513
72548477|NCT00266409|144626418|SUPERIORITY_OR_OTHER|||||||0.393||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAM-A insomnia subscore as a covariate|ANCOVA|||||||0.3930
72548478|NCT00266409|144626418|SUPERIORITY_OR_OTHER|||||||0.5461||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAM-A insomnia subscore as a covariate|ANCOVA|||||||0.5461
72548479|NCT00266409|144626419|SUPERIORITY_OR_OTHER|||||||0.0722||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAM-A insomnia subscore as a covariate|ANCOVA|||||||0.0722
72548480|NCT00266409|144626419|SUPERIORITY_OR_OTHER|||||||0.4639||95.0||||P-values based on an ANCOVA with treatment as a fixed effect and baseline HAM-A insomnia subscore as a covariate|ANCOVA|||||||0.4639
72582099|NCT02513160|144694978|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|-1.1|||<|0.0001|TWO_SIDED|95.0|-1.482|-0.717||a priori threshold for significance of 0.05.|mixed model for repeated measures|MMRM analysis with covariates for baseline, sex, age, current asthma therapy, treatment, week, and treatment by week interaction.|Active - placebo|Sequential order of analyses described in Outcome #2, analysis #1.||-0.717|-1.482|<0.0001
72548481|NCT00266409|144626420|SUPERIORITY_OR_OTHER|||||||0.0075||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAMA-A psychic factors subscore as a covariate|ANCOVA|||||||0.0075
72548482|NCT00266409|144626420|SUPERIORITY_OR_OTHER|||||||0.1641||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAM-A psychic factors subscore as a covariate|ANCOVA|||||||0.1641
72548483|NCT00266409|144626421|SUPERIORITY_OR_OTHER|||||||0.0932||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAMA-A psychic factors subscore as a covariate|ANCOVA|||||||0.0932
72548484|NCT00266409|144626421|SUPERIORITY_OR_OTHER|||||||0.0852||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAMA-A psychic factors subscore as a covariate|ANCOVA|||||||0.0852
72548485|NCT00266409|144626422|SUPERIORITY_OR_OTHER|||||||0.7896||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAMA-A psychic factors subscore as a covariate|ANCOVA|||||||0.7896
72582100|NCT02513160|144694978|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|-1.03|||<|0.0001|TWO_SIDED|95.0|-1.415|-0.643||a priori threshold for significance of 0.05.|mixed model for repeated measures|MMRM analysis with covariates for baseline, sex, age, current asthma therapy, treatment, week, and treatment by week interaction.|Active - placebo|Comparisons for MDI dose versus placebo for the secondary efficacy endpoints were used for assay sensitivity.||-0.643|-1.415|<0.0001
72548486|NCT00266409|144626422|SUPERIORITY_OR_OTHER|||||||0.9651||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAMA-A psychic factors subscore as a covariate|ANCOVA|||||||0.9651
72548487|NCT00266409|144626423|SUPERIORITY_OR_OTHER|||||||0.828||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAMA-A psychic factors subscore as a covariate|ANCOVA|||||||0.8280
72582101|NCT02513160|144694979|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|-0.32|||<|0.0001|TWO_SIDED|95.0|-0.44|-0.203||a priori threshold for significance of 0.05.|mixed model for repeated measures|MMRM analysis with covariates for baseline, sex, age, current asthma therapy, treatment, week, and treatment by week interaction.|Active - placebo|Sequential order of analyses described in Outcome #2, analysis #1.||-0.203|-0.440|<0.0001
72582102|NCT02513160|144694979|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|-0.25|||<|0.0001|TWO_SIDED|95.0|-0.365|-0.128||a priori threshold for significance of 0.05.|mixed model for repeated measures|MMRM analysis with covariates for baseline, sex, age, current asthma therapy, treatment, week, and treatment by week interaction.|Active - placebo|Sequential order of analyses described in Outcome #2, analysis #1.||-0.128|-0.365|<0.0001
72582103|NCT02513160|144694979|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|-0.3|||<|0.0001|TWO_SIDED|95.0|-0.423|-0.185||a priori threshold for significance of 0.05.|mixed model for repeated measures|MMRM analysis with covariates for baseline, sex, age, current asthma therapy, treatment, week, and treatment by week interaction.|Active - placebo|Comparisons for MDI dose versus placebo for the secondary efficacy endpoints were used for assay sensitivity.||-0.185|-0.423|<0.0001
72582104|NCT02513160|144694980|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0058|||||||Log Rank|||||||0.0058
72582105|NCT02513160|144694980|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0014|||||||Log Rank|||||||0.0014
72582106|NCT02513160|144694980|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0062|||||||Log Rank|||||||0.0062
72582107|NCT05258773|144694985|SUPERIORITY||LS Mean difference Arm A - Arm B|-11.0||||0.1406|TWO_SIDED|95.0|-25.9|3.9||An analysis of covariance (ANCOVA) model was used to assess changes from baseline at 500Hz at the Day 49 visit comparing the treatment groups.The treatment group was included as a fixed factor, with baseline values as a covariate.|ANCOVA||The change in hearing threshold from baseline was expected to be smaller in the treated group (arm A) than in the control group (arm B).|||3.9|-25.9|0.1406
72582108|NCT05258773|144694985|SUPERIORITY||LS Mean difference Arm A - Arm B|-14.4||||0.0567|TWO_SIDED|95.0|-29.24|0.45||An ANCOVA model was used to assess changes from baseline at the average across three frequencies (250-750 Hz) at the Day 49 visit comparing the treatment groups. The treatment group was included as a fixed factor, with baseline values as a covariate.|ANCOVA||The change in hearing threshold from baseline was expected to be smaller in the treated group (arm A) than in the control group (arm B).|||0.45|-29.24|0.0567
72582109|NCT05258773|144694985|SUPERIORITY||LS Mean difference Arm A - Arm B|-9.0||||0.2588|TWO_SIDED|95.0|-25.0|7.1||An ANCOVA model was used to assess changes from baseline at 500Hz at EOS on Day 105 comparing the treatment groups.The treatment group was included as a fixed factor, with baseline values as a covariate.|ANCOVA||The change in hearing threshold from baseline was expected to be smaller in the treated group (arm A) than in the control group (arm B).|||7.1|-25.0|0.2588
72582110|NCT05258773|144694985|SUPERIORITY||LS Mean difference Arm A - Arm B|-13.84||||0.0979|TWO_SIDED|95.0|-30.49|2.8||An ANCOVA model was used to assess changes from baseline at the average across three frequencies (250-750 Hz) at EOS on Day 105, comparing the treatment groups. The treatment group was included as a fixed factor, with baseline values as a covariate.|ANCOVA||The change in hearing threshold from baseline was expected to be smaller in the treated group (arm A) than in the control group (arm B).|||2.80|-30.49|0.0979
72582111|NCT05277922|144694987|SUPERIORITY||Geometric mean ratio|0.9999|||||TWO_SIDED|95.0|0.8313|1.2025||||||||1.2025|0.8313|
72582112|NCT05277922|144694987|SUPERIORITY||Geometric mean ratio|1.2454|||||TWO_SIDED|95.0|1.0355|1.4979||||||||1.4979|1.0355|
72582113|NCT05277922|144694987|SUPERIORITY||Geometric mean ratio|1.2392|||||TWO_SIDED|95.0|1.0304|1.4904||||||||1.4904|1.0304|
72582114|NCT05277922|144694987|SUPERIORITY||Geometric mean ratio|1.2394|||||TWO_SIDED|95.0|1.0305|1.4906||||||||1.4906|1.0305|
72582115|NCT05277922|144694987|SUPERIORITY||Geometric mean ratio|0.995|||||TWO_SIDED|95.0|0.8273|1.1967||||||||1.1967|0.8273|
72582116|NCT05277922|144694987|SUPERIORITY||Geometric mean ratio|1.5058|||||TWO_SIDED|95.0|1.252|1.811||||||||1.8110|1.2520|
72582117|NCT05277922|144694987|SUPERIORITY||Geometric mean ratio|1.506|||||TWO_SIDED|95.0|1.2522|1.8113||||||||1.8113|1.2522|
72582118|NCT05277922|144694987|SUPERIORITY||Geometric mean ratio|1.2091|||||TWO_SIDED|95.0|1.0053|1.4541||||||||1.4541|1.0053|
72582119|NCT05277922|144694987|SUPERIORITY||Geometric mean ratio|1.2151|||||TWO_SIDED|95.0|1.0103|1.4614||||||||1.4614|1.0103|
72582120|NCT05277922|144694987|SUPERIORITY||Geometric mean ratio|1.2456|||||TWO_SIDED|95.0|1.0357|1.4981||||||||1.4981|1.0357|
72582121|NCT03593473|144694995|SUPERIORITY|||||||0.37|||||||t-test, 2 sided|||T-test comparing mean cortisol by study arm at -40 minutes.||||0.37
72582122|NCT03593473|144694995|SUPERIORITY|||||||0.4|||||||t-test, 2 sided|||T-test comparing mean cortisol by study arm at -20 minutes.||||0.40
72582123|NCT03593473|144694995|SUPERIORITY|||||||0.63|||||||t-test, 2 sided|||T-test comparing mean cortisol by study arm at 0 minutes.||||0.63
72412495|NCT03029208|144333141|SUPERIORITY||LS mean difference|3.23||||0.8168|TWO_SIDED|95.0|-3.82|10.27|||Mixed model repeated measures (MMRM)||The difference in change from Baseline in SBP at Week 52 was analyzed with a MMRM approach with an unstructured covariance matrix to compare the difference in LS means between arms.|||10.27|-3.82|0.8168
72412496|NCT03029208|144333141|SUPERIORITY||LS mean difference|4.21||||0.9793|TWO_SIDED|95.0|0.17|8.26|||MMRM||The difference in change from Baseline in DBP at Week 52 was analyzed with a MMRM approach with an unstructured covariance matrix to compare the difference in LS means between arms.|||8.26|0.17|0.9793
72412497|NCT03029208|144333141|SUPERIORITY||LS mean difference|4.1||||0.9597|TWO_SIDED|95.0|-0.51|8.7|||MMRM||The difference in change from Baseline in MAP at Week 52 was analyzed with a MMRM approach with an unstructured covariance matrix to compare the difference in LS means between arms.|||8.70|-0.51|0.9597
72412498|NCT03029208|144333142|SUPERIORITY||LS mean difference|-0.09||||0.484|TWO_SIDED|95.0|-4.72|4.53|||ANCOVA||The difference in change from Baseline in SBP at the derived end of treatment was analyzed with an ANCOVA model including terms for treatment, prognostic randomization stratification factors.|||4.53|-4.72|0.4840
72412499|NCT03029208|144333142|SUPERIORITY||LS mean difference|1.99||||0.9156|TWO_SIDED|95.0|-0.85|4.82|||ANCOVA||The difference in change from Baseline in DBP at the derived end of treatment was analyzed with an ANCOVA model including terms for treatment, prognostic randomization stratification factors.|||4.82|-0.85|0.9156
72412500|NCT03029208|144333142|SUPERIORITY||LS mean difference|1.29||||0.7966|TWO_SIDED|95.0|-1.76|4.33|||ANCOVA||The difference in change from Baseline in MAP at the derived end of treatment was analyzed with an ANCOVA model including terms for treatment, prognostic randomization stratification factors.|||4.33|-1.76|0.7966
72412501|NCT03029208|144333143|SUPERIORITY||Ratio of exacerbation rate|1.01||||0.5174|TWO_SIDED|95.0|0.73|1.39|||Negative binomial model||Model estimated exacerbation rates, ratio of model estimated exacerbation rates and CIs were estimated using a negative binomial model for the treatment group comparison.|||1.39|0.73|0.5174
72412502|NCT03029208|144333145|NON_INFERIORITY|Non-inferiority was to be established if the lower limit of the two-sided 95% CI for the treatment difference was greater than the pre-specified non-inferiority margin of -0.75 g/dL.|LS mean difference|0.04|||||TWO_SIDED|95.0|-0.29|0.36|||||The difference in change from Baseline in post-randomization Hgb at Week 52 was analyzed with a MMRM approach with an unstructured covariance matrix to compare the difference in LS means between arms.|||0.36|-0.29|
72412503|NCT03029208|144333146|SUPERIORITY||Difference in response rate|-0.8||||0.5411|TWO_SIDED|95.0|-12.2|10.7|||Cochran-Mantel-Haenszel||A Cochran-Mantel-Haenszel (CMH) test adjusted for treatment and randomization stratification factors were used to compare the number of responders between the treatment groups.|||10.7|-12.2|0.5411
72548488|NCT00266409|144626423|SUPERIORITY_OR_OTHER|||||||0.0936||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAMA-A psychic factors subscore as a covariate|ANCOVA|||||||0.0936
72548489|NCT00266409|144626424|SUPERIORITY_OR_OTHER|||||||0.3539||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAMA-A psychic factors subscore as a covariate|ANCOVA|||||||0.3539
72582124|NCT03593473|144694995|SUPERIORITY|||||||0.72|||||||t-test, 2 sided|||T-test comparing mean cortisol by study arm at 10 minutes.||||0.72
72412504|NCT03029208|144333147|NON_INFERIORITY|Non-inferiority was to be established if the lower limit of the two-sided 95% confidence interval for the treatment difference was greater than non-inferiority margin of -15%.|Median Difference (Final Values)|2.05|||||TWO_SIDED|95.0|-4.45|11.27|||||Hodges-Lehmann Estimate of Treatment Difference has been reported.|||11.27|-4.45|
72412505|NCT03029208|144333148|SUPERIORITY||Probability|0.54||||0.1538|TWO_SIDED|95.0|0.46|0.61|||van Elteren test||Mann-Whitney estimate (Probability) of the treatment effect has been presented.|||0.61|0.46|0.1538
72412506|NCT03029208|144333149|OTHER||Hazard Ratio (HR)|1.06||||0.5348|TWO_SIDED|95.0|0.31|3.66|||Wald test||Hazard ratio was estimated using a Cox proportional hazard regression model adjusted for treatment group, dialysis type and dialysis start manner.|||3.66|0.31|0.5348
72548490|NCT00266409|144626424|SUPERIORITY_OR_OTHER|||||||0.4672||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAMA-A psychic factors subscore as a covariate|ANCOVA|||||||0.4672
72548491|NCT00266409|144626425|SUPERIORITY_OR_OTHER|||||||0.255||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAMA-A psychic factors subscore as a covariate|ANCOVA|||||||0.2550
72548492|NCT00266409|144626425|SUPERIORITY_OR_OTHER|||||||0.3125||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAMA-A psychic factors subscore as a covariate|ANCOVA|||||||0.3125
72548493|NCT00266409|144626426|SUPERIORITY_OR_OTHER|||||||0.3174||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAMA-A psychic factors subscore as a covariate|ANCOVA|||||||0.3174
72548494|NCT00266409|144626426|SUPERIORITY_OR_OTHER|||||||0.9427||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAMA-A psychic factors subscore as a covariate|ANCOVA|||||||0.9427
72582125|NCT03593473|144694995|SUPERIORITY|||||||0.88|||||||t-test, 2 sided|||T-test comparing mean cortisol by study arm at 15 minutes.||||0.88
72582126|NCT03593473|144694995|SUPERIORITY|||||||0.85|||||||t-test, 2 sided|||T-test comparing mean cortisol by study arm at 28 minutes.||||0.85
72412507|NCT03029208|144333150|SUPERIORITY||LS mean difference|-0.39||||0.6641|TWO_SIDED|95.0|-2.22|1.44|||MMRM||SF-36 HRQoL PCS domain score was analyzed using an MMRM approach with an unstructured covariance matrix to compare the difference in LS means between arms at Week 8.|||1.44|-2.22|0.6641
72412508|NCT03029208|144333150|SUPERIORITY||LS mean difference|1.13||||0.103|TWO_SIDED|95.0|-0.63|2.89|||MMRM||SF-36 HRQoL PCS domain score was analyzed using an MMRM approach with an unstructured covariance matrix to compare the difference in LS means between arms at Week 12.|||2.89|-0.63|0.1030
72412509|NCT03029208|144333150|SUPERIORITY||LS mean difference|0.49||||0.3157|TWO_SIDED|95.0|-1.51|2.48|||MMRM||SF-36 HRQoL PCS domain score was analyzed using an MMRM approach with an unstructured covariance matrix to compare the difference in LS means between arms at Week 28.|||2.48|-1.51|0.3157
72582127|NCT03593473|144694995|SUPERIORITY|||||||0.72|||||||t-test, 2 sided|||T-test comparing mean cortisol by study arm at 38 minutes.||||0.72
72582128|NCT03593473|144694995|SUPERIORITY|||||||0.57|||||||t-test, 2 sided|||T-test comparing mean cortisol by study arm at 48 minutes.||||0.57
72548495|NCT00266409|144626427|SUPERIORITY_OR_OTHER|||||||0.3252||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAMA-A psychic factors subscore as a covariate|ANCOVA|||||||0.3252
72548496|NCT00266409|144626427|SUPERIORITY_OR_OTHER|||||||0.609||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAMA-A psychic factors subscore as a covariate|ANCOVA|||||||0.6090
72548497|NCT00266409|144626428|SUPERIORITY_OR_OTHER|||||||0.1247||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAMA-A psychic factors subscore as a covariate|ANCOVA|||||||0.1247
72548498|NCT00266409|144626428|SUPERIORITY_OR_OTHER|||||||0.843||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAMA-A psychic factors subscore as a covariate|ANCOVA|||||||0.8430
72548499|NCT00266409|144626429|SUPERIORITY_OR_OTHER|||||||0.1031||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAMA-A somatic subscore as a covariate|ANCOVA|||||||0.1031
72548500|NCT00266409|144626429|SUPERIORITY_OR_OTHER|||||||0.0543||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAMA-A somatic subscore as a covariate|ANCOVA|||||||0.0543
72548501|NCT00266409|144626430|SUPERIORITY_OR_OTHER|||||||0.0508||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAMA-A somatic subscore as a covariate|ANCOVA|||||||0.0508
72412510|NCT03029208|144333150|SUPERIORITY||LS mean difference|-1.31||||0.8855|TWO_SIDED|95.0|-3.46|0.84|||MMRM||SF-36 HRQoL PCS domain score was analyzed using an MMRM approach with an unstructured covariance matrix to compare the difference in LS means between arms at Week 52.|||0.84|-3.46|0.8855
72548502|NCT00266409|144626430|SUPERIORITY_OR_OTHER|||||||0.0871||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAMA-A somatic subscore as a covariate|ANCOVA|||||||0.0871
72548503|NCT00266409|144626431|SUPERIORITY_OR_OTHER|||||||0.8318||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAMA-A somatic subscore as a covariate|ANCOVA|||||||0.8318
72548504|NCT00266409|144626431|SUPERIORITY_OR_OTHER|||||||0.5375||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAMA-A somatic subscore as a covariate|ANCOVA|||||||0.5375
72548505|NCT00266409|144626432|SUPERIORITY_OR_OTHER|||||||0.2186||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAMA-A somatic subscore as a covariate|ANCOVA|||||||0.2186
72548506|NCT00266409|144626432|SUPERIORITY_OR_OTHER|||||||0.0422||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAMA-A somatic subscore as a covariate|ANCOVA|||||||0.0422
72548507|NCT00266409|144626433|SUPERIORITY_OR_OTHER|||||||0.1164||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAMA-A somatic subscore as a covariate|ANCOVA|||||||0.1164
72548508|NCT00266409|144626433|SUPERIORITY_OR_OTHER|||||||0.1935||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAMA-A somatic subscore as a covariate|ANCOVA|||||||0.1935
72548509|NCT00266409|144626434|SUPERIORITY_OR_OTHER|||||||0.1244||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAMA-A somatic subscore as a covariate|ANCOVA|||||||0.1244
72548510|NCT00266409|144626434|SUPERIORITY_OR_OTHER|||||||0.6182||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAMA-A somatic subscore as a covariate|ANCOVA|||||||0.6182
72548511|NCT00266409|144626435|SUPERIORITY_OR_OTHER|||||||0.4589||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAMA-A somatic subscore as a covariate|ANCOVA|||||||0.4589
72548512|NCT00266409|144626435|SUPERIORITY_OR_OTHER|||||||0.393||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAMA-A somatic subscore as a covariate|ANCOVA|||||||0.3930
72548513|NCT00266409|144626436|SUPERIORITY_OR_OTHER|||||||0.445||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAMA-A somatic subscore as a covariate|ANCOVA|||||||0.4450
72548514|NCT00266409|144626436|SUPERIORITY_OR_OTHER|||||||0.2924||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAMA-A somatic subscore as a covariate|ANCOVA|||||||0.2924
72548515|NCT00266409|144626437|SUPERIORITY_OR_OTHER|||||||0.2184||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAMA-A somatic subscore as a covariate|ANCOVA|||||||0.2184
72548516|NCT00266409|144626437|SUPERIORITY_OR_OTHER|||||||0.1281||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAMA-A psychic factors subscore as a covariate|ANCOVA|||||||0.1281
72548517|NCT00266409|144626438|SUPERIORITY_OR_OTHER|||||||0.6602||95.0|||||Chi-squared|||test of difference in percentage of subjects reporting any panic attack||||0.6602
72548518|NCT00266409|144626439|SUPERIORITY_OR_OTHER|||||||0.5544||95.0|||||Chi-squared|||test of difference in percentage of subjects reporting any panic attack||||0.5544
72548519|NCT00266409|144626440|SUPERIORITY_OR_OTHER|||||||0.9269||95.0|||||Chi-squared|||test of difference in percentage of subjects reporting any panic attack||||0.9269
72548520|NCT00266409|144626441|SUPERIORITY_OR_OTHER|||||||0.5271||95.0|||||Chi-squared|||test of difference in percentage of subjects reporting any panic attack||||0.5271
72548521|NCT00266409|144626442|SUPERIORITY_OR_OTHER|||||||0.1447||95.0|||||Chi-squared|||test of difference in percentage of subjects reporting any panic attack||||0.1447
72548522|NCT00266409|144626443|SUPERIORITY_OR_OTHER|||||||0.9375||95.0||||P-value from a Chi-squared test|Chi-squared|||||||0.9375
72548523|NCT00266409|144626444|SUPERIORITY_OR_OTHER|||||||0.9883||95.0|||||Chi-squared|||test of difference in percentage of subjects reporting any panic attack||||0.9883
72548524|NCT00266409|144626445|SUPERIORITY_OR_OTHER|||||||0.3093||95.0|||||Chi-squared|||test of difference in percentage of subjects reporting any panic attack||||0.3093
72548525|NCT00266409|144626446|SUPERIORITY_OR_OTHER|||||||0.5824||95.0|||||Chi-squared|||test of difference in percentage of subjects reporting any panic attack||||0.5824
72548526|NCT00266409|144626447|SUPERIORITY_OR_OTHER|||||||0.044||95.0|||||Generalized Wilcoxon Test|||This analysis refers to the test of the null hypothesis that there is no difference in the survival distribution function between the treatment groups.||||0.044
72548527|NCT00266409|144626447|SUPERIORITY_OR_OTHER|||||||0.6587||95.0|||||Generalized Wilcoxon Test|||This analysis refers to the test of the null hypothesis that there is no difference in the survival distribution function between the treatment groups.||||0.6587
72412511|NCT03029208|144333151|SUPERIORITY||LS mean difference|-0.67||||0.7146|TWO_SIDED|95.0|-2.99|1.66|||MMRM||SF-36 HRQoL MCS domain score was analyzed using an MMRM approach with an unstructured covariance matrix to compare the difference in LS means between arms at Week 8.|||1.66|-2.99|0.7146
72412512|NCT03029208|144333151|SUPERIORITY||LS mean difference|-1.53||||0.905|TWO_SIDED|95.0|-3.82|0.76|||MMRM||SF-36 HRQoL MCS domain score was analyzed using an MMRM approach with an unstructured covariance matrix to compare the difference in LS means between arms at Week 12.|||0.76|-3.82|0.9050
72412513|NCT03029208|144333151|SUPERIORITY||LS mean difference|-0.32||||0.595|TWO_SIDED|95.0|-2.91|2.28|||MMRM||SF-36 HRQoL MCS domain score was analyzed using an MMRM approach with an unstructured covariance matrix to compare the difference in LS means between arms at Week 28.|||2.28|-2.91|0.5950
72548528|NCT00635154|144626451|SUPERIORITY_OR_OTHER||Proportion of confirmed responses (%)|1.8||||||95.0|0.5|10.0|||||95% Confidence intervals were calculated for the true confirmed response rate using properties of the binomial distribution.|Proportion of confirmed responses to Anakinra alone was estimated by the number of patients who achieved a confirmed response divided by the total number of assessable patients.||10|0.5|
72548529|NCT01399736|144626458|SUPERIORITY||Hazard Ratio (HR)|0.35|||<|0.001|TWO_SIDED|95.0|0.22|0.55|||Chi-squared|||||0.55|0.22|<0.001
72548530|NCT01399736|144626459|SUPERIORITY||Hazard Ratio (HR)|0.8||||0.7|TWO_SIDED|95.0|0.25|2.56|||Chi-squared|||||2.56|0.25|0.70
72548531|NCT01399736|144626460|SUPERIORITY||Hazard Ratio (HR)|1.0||||1|TWO_SIDED|95.0|0.25|4.01|||Chi-squared|||||4.01|0.25|1.00
72548532|NCT01399736|144626461|SUPERIORITY||Hazard Ratio (HR)|0.5||||0.1|TWO_SIDED|95.0|0.22|1.13|||Chi-squared|||||1.13|0.22|0.10
72548533|NCT01399736|144626462|SUPERIORITY||Hazard Ratio (HR)|0.59||||0.29|TWO_SIDED|95.0|0.22|1.59|||Chi-squared|||||1.59|0.22|0.29
72548534|NCT01399736|144626463|SUPERIORITY||Hazard Ratio (HR)|0.37|||<|0.001|TWO_SIDED|95.0|0.24|0.57|||Chi-squared|||||0.57|0.24|<0.001
72548535|NCT01399736|144626464|SUPERIORITY||Hazard Ratio (HR)|1.2||||0.8|TWO_SIDED|95.0|0.29|5.02|||Chi-squared|||||5.02|0.29|0.80
72548536|NCT04799158|144626515|SUPERIORITY||Percentage difference|28.7|||<|0.0001|TWO_SIDED|95.0|21.84|35.55|||Fisher Exact|||||35.55|21.84|<0.0001
72548537|NCT04799158|144626515|SUPERIORITY||Percentage difference|33.3|||<|0.0001|TWO_SIDED|95.0|26.28|40.23|||Fisher Exact|||||40.23|26.28|<0.0001
72548538|NCT04799158|144626515|SUPERIORITY||Percentage difference|42.7|||<|0.0001|TWO_SIDED|95.0|35.92|49.42|||Fisher Exact|||||49.42|35.92|<0.0001
72548539|NCT04799158|144626516|SUPERIORITY||Percentage difference|30.3|||<|0.0001|TWO_SIDED|95.0|23.41|37.09|||Fisher Exact|||||37.09|23.41|<0.0001
72548540|NCT04799158|144626516|SUPERIORITY||Percentage difference|23.9|||<|0.0001|TWO_SIDED|95.0|16.67|31.05|||Fisher Exact|||||31.05|16.67|<0.0001
72548541|NCT04799158|144626516|SUPERIORITY||Percentage difference|37.7|||<|0.0001|TWO_SIDED|95.0|31.0|44.35|||Fisher Exact|||||44.35|31.00|<0.0001
72548542|NCT04799158|144626517|SUPERIORITY|||||||0.1771|||||||Wilcoxon rank-sum test|||||||0.1771
72548543|NCT04799158|144626517|SUPERIORITY|||||||0.1551|||||||Wilcoxon rank-sum test|||||||0.1551
72548544|NCT04799158|144626517|SUPERIORITY|||||||0.0094|||||||Wilcoxon rank-sum test|||||||0.0094
72548545|NCT04799158|144626518|SUPERIORITY|||||||0.3395|||||||Wilcoxon rank-sum test|||||||0.3395
72548546|NCT04799158|144626518|SUPERIORITY|||||||0.4882|||||||Wilcoxon rank-sum test|||||||0.4882
72548547|NCT04799158|144626518|SUPERIORITY|||||||0.0722|||||||Wilcoxon rank-sum test|||||||0.0722
72548548|NCT04799158|144626519|SUPERIORITY||Percentage difference|-3.9||||0.83|TWO_SIDED|95.0|-24.41|16.52|||Fisher Exact|||||16.52|-24.41|0.8300
72548549|NCT04799158|144626519|SUPERIORITY||Percentage difference|1.4|||>|0.9999|TWO_SIDED|95.0|-19.28|22.16|||Fisher Exact|||||22.16|-19.28|>0.9999
72548550|NCT04799158|144626519|SUPERIORITY||Percentage difference|2.3|||>|0.9999|TWO_SIDED|95.0|-18.22|22.88|||Fisher Exact|||||22.88|-18.22|>0.9999
72548551|NCT04799158|144626520|SUPERIORITY|||||||0.4684|||||||Wilcoxon rank-sum test|||||||0.4684
72548552|NCT04799158|144626520|SUPERIORITY|||||||0.656|||||||Wilcoxon rank-sum test|||||||0.6560
72548553|NCT04799158|144626520|SUPERIORITY|||||||0.6324|||||||Wilcoxon rank-sum test|||||||0.6324
72548554|NCT04799158|144626521|SUPERIORITY|||||||0.9896|||||||Wilcoxon rank-sum test|||||||0.9896
72548555|NCT04799158|144626521|SUPERIORITY|||||||0.6916|||||||Wilcoxon rank-sum test|||||||0.6916
72548556|NCT04799158|144626521|SUPERIORITY|||||||0.9316|||||||Wilcoxon rank-sum test|||||||0.9316
72548557|NCT00918567|144626573|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.22|STANDARD_ERROR_OF_MEAN|1.93|<|0.05|TWO_SIDED|||||Also tested marginal effects defined as p \< .10.|Mixed Models Analysis|Tukey-Kramer adjustments for post-hoc differences of least squares comparisons||||||<.05
72548558|NCT00918567|144626574|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.18|STANDARD_ERROR_OF_MEAN|0.51|<|0.05|TWO_SIDED|||||Also examined marginal effects, defined as p\<.10|Mixed Models Analysis|||||||<.05
72548559|NCT00918567|144626575|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.27|STANDARD_ERROR_OF_MEAN|0.6|<|0.05|TWO_SIDED|||||Also tested marginal effects defined as p\<.10|Mixed Models Analysis|||||||<.05
72548560|NCT00918567|144626576|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.09|<|0.05|TWO_SIDED|||||Also estimated marginal effects defined as p\<.10|Mixed Models Analysis|||||||<.05
72548561|NCT00918567|144626577|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.07|<|0.05|TWO_SIDED|||||also tested marginal effects defined as p\<.10|Mixed Models Analysis|||||||<.05
72548562|NCT00918567|144626578|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.22|STANDARD_ERROR_OF_MEAN|0.18|>|0.05|TWO_SIDED|||||Also tested marginal effects defined as p\<.10|Mixed Models Analysis|||||||>.05
72548563|NCT00918567|144626579|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.17|STANDARD_ERROR_OF_MEAN|0.2|<|0.05|TWO_SIDED|||||Also tested marginal effects (p\<.10)|Mixed Models Analysis|||||||<.05
72548564|NCT00918567|144626580|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.05|STANDARD_ERROR_OF_MEAN|1.7|<|0.05|TWO_SIDED|||||Also tested marginal effects (p\<.10)|Mixed Models Analysis|||||||<0.05
72548565|NCT00918567|144626581|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.08|STANDARD_ERROR_OF_MEAN|1.8|<|0.05|TWO_SIDED|||||Also tested marginal effects (p\<.10)|Mixed Models Analysis|||||||<.05
72548566|NCT00918567|144626582|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.4|STANDARD_ERROR_OF_MEAN|0.15|<|0.05|TWO_SIDED|||||Also tested marginal effect (p\<.10)|Mixed Models Analysis|||||||<.05
72548567|NCT00918567|144626583|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.12|STANDARD_ERROR_OF_MEAN|0.19|<|0.05|TWO_SIDED|||||Also tested marginal effects (p\<.10)|Mixed Models Analysis|||||||<.05
72548568|NCT01055223|144626584|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.42|||||TWO_SIDED|95.0|1.13|1.78|||||Unadjusted Odds Ratio. Reference group: TZD alone.|||1.78|1.13|
72548569|NCT01055223|144626584|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.19|||||TWO_SIDED|95.0|0.93|1.52|||||Adjusted Odds Ratio. Reference group TZD alone. Adjusted: age, liver disease, angina, renal and heart failure, asthma, stroke, epilepsy, RA, antihypertensives, statins, corticosteroids, antiepileptics, benzodiazepines, HRT, bisphosphonates.|||1.52|0.93|
72548570|NCT01055223|144626584|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.53|||||TWO_SIDED|95.0|0.78|2.98|||||Unadjusted Odds Ratio. Reference group: TZD alone.|||2.98|0.78|
72548571|NCT01055223|144626584|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.46|||||TWO_SIDED|95.0|0.74|2.89|||||Adjusted Odds Ratio. Reference group TZD alone. Adjusted: age, liver disease, angina, renal and heart failure, asthma, stroke, epilepsy, RA, antihypertensives, statins, corticosteroids, antiepileptics, benzodiazepines, HRT, bisphosphonates.|||2.89|0.74|
72548572|NCT01055223|144626584|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.01|||||TWO_SIDED|95.0|0.18|22.14|||||Undadjusted Odds Ratio. Reference Group: TZD alone.|||22.14|0.18|
72582129|NCT03593473|144694995|SUPERIORITY|||||||0.96|||||||Mixed Models Analysis|||A mixed effects model with random intercept and slope was used to model cortisol as the outcome variable with time, study arm, and an interaction between time and study arm as the exposure variables. Times are restricted to times 0, +10, +15, and +28, which reflect the measures taken during the Trier Social Stress Test. The p-value presented below is for the interaction term between time and study arm.||||0.96
72582130|NCT03593473|144694996|SUPERIORITY|||||||0.71|||||||t-test, 2 sided|||T-test comparing mean ACTH by study arm at -40 minutes.||||0.71
72582131|NCT03593473|144694996|SUPERIORITY|||||||0.92|||||||t-test, 2 sided|||T-test comparing mean ACTH by study arm at -20 minutes.||||0.92
72582132|NCT03593473|144694996|SUPERIORITY|||||||0.92|||||||t-test, 2 sided|||T-test comparing mean ACTH by study arm at 0 minutes.||||0.92
72582133|NCT03593473|144694996|SUPERIORITY|||||||0.4|||||||t-test, 2 sided|||T-test comparing mean ACTH by study arm at 10 minutes.||||0.40
72548573|NCT01055223|144626584|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.34|||||TWO_SIDED|95.0|0.12|15.5|||||Adjusted Odds Ratio. Reference group TZD alone. Adjusted: age, liver disease, angina, renal and heart failure, asthma, stroke, epilepsy, RA, antihypertensives, statins, corticosteroids, antiepileptics, benzodiazepines, HRT, bisphosphonates.|||15.50|0.12|
72548574|NCT01055223|144626585|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.41|||||TWO_SIDED|95.0|1.05|1.89|||||Unadjusted Odds Ratio. Reference group: TZD alone.|||1.89|1.05|
72548575|NCT01055223|144626585|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.2|||||TWO_SIDED|95.0|0.88|1.65|||||Adjusted Odds Ratio. Reference group TZD alone. Adjusted: age, liver disease, angina, renal and heart failure, asthma, stroke, epilepsy, RA, antihypertensives, statins, corticosteroids, antiepileptics, benzodiazepines, HRT, bisphosphonates.|||1.65|0.88|
72548576|NCT01055223|144626585|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.58|||||TWO_SIDED|95.0|0.69|3.6|||||Unadjusted Odds Ratio. Reference group: TZD alone.|||3.60|0.69|
72582134|NCT03593473|144694996|SUPERIORITY|||||||0.97|||||||t-test, 2 sided|||T-test comparing mean ACTH by study arm at 15 minutes.||||0.97
72582135|NCT03593473|144694996|SUPERIORITY|||||||0.71|||||||t-test, 2 sided|||T-test comparing mean ACTH by study arm at 28 minutes.||||0.71
72548577|NCT01055223|144626585|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.63|||||TWO_SIDED|95.0|0.7|3.81|||||Adjusted Odds Ratio. Reference group TZD alone. Adjusted: age, liver disease, angina, renal and heart failure, asthma, stroke, epilepsy, RA, antihypertensives, statins, corticosteroids, antiepileptics, benzodiazepines, HRT, bisphosphonates.|||3.81|0.70|
72582136|NCT03593473|144694996|SUPERIORITY|||||||0.78|||||||t-test, 2 sided|||T-test comparing mean ACTH by study arm at 38 minutes.||||0.78
72582137|NCT03593473|144694996|SUPERIORITY|||||||0.63|||||||t-test, 2 sided|||T-test comparing mean ACTH by study arm at 48 minutes.||||0.63
72582138|NCT03593473|144694996|SUPERIORITY|||||||0.11|||||||Mixed Models Analysis|||A mixed effects model with random intercept and slope was used to model cortisol as the outcome variable with time, study arm, and an interaction between time and study arm as the exposure variables. This is the p-value for the interaction term between time and study arm.||||0.11
72582139|NCT03593473|144694997|SUPERIORITY|||||||0.07|||||||Fisher's Z test|||Fisher's Z test for correlation between ACTH at -40 minutes and Cortisol at -20 minutes.||||0.07
72582140|NCT03593473|144694997|SUPERIORITY|||||||0.22|||||||Fisher's Z test|||Fisher's Z test for correlation between ACTH at -20 minutes and Cortisol at 0 minutes.||||0.22
72548578|NCT01055223|144626585|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.0|||||TWO_SIDED|95.0|0.0|0.0|||||Unadjusted Odds Ratio. Small numbers model didn't converge. Reference group: TZD alone.|||0.00|0.00|
72548579|NCT01055223|144626585|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.0|||||TWO_SIDED|95.0|0.0|0.0|||||Small numbers model didn't converge. Ref grp: TZD alone. Adjusted: age, liver disease, angina, renal and heart failure, asthma, stroke, epilepsy, RA, antihypertensives, statins, corticosteroids, antiepileptics, benzodiazepines, HRT, bisphosphonates.|||0.00|0.00|
72548580|NCT01055223|144626586|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.29|||||TWO_SIDED|95.0|0.92|1.79|||||Unadjusted Odds Ratio. Reference Group: TZD alone.|||1.79|0.92|
72548581|NCT01055223|144626586|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.01|||||TWO_SIDED|95.0|0.71|1.45|||||Adjusted Odds Ratio. Reference group TZD alone. Adjusted: age, liver disease, angina, renal and heart failure, asthma, stroke, epilepsy, RA, antihypertensives, statins, corticosteroids, antiepileptics, benzodiazepines, HRT, bisphosphonates.|||1.45|0.71|
72548582|NCT01055223|144626586|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.44|||||TWO_SIDED|95.0|0.1|1.9|||||Unadjusted Odds Ratio. Reference group: TZD alone.|||1.90|0.10|
72582141|NCT03593473|144694997|SUPERIORITY|||||||0.14|||||||Fisher's Z test|||Fisher's Z test for correlation between ACTH at 0 minutes and Cortisol at +10 minutes.||||0.14
72582142|NCT03593473|144694997|SUPERIORITY|||||||0.14|||||||Fisher's Z test|||Fisher's Z test for correlation between ACTH at +10 minutes and Cortisol at +15 minutes.||||0.14
72548583|NCT01055223|144626586|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.35|||||TWO_SIDED|95.0|0.08|1.54|||||Adjusted Odds Ratio. Reference group TZD alone. Adjusted: age, liver disease, angina, renal and heart failure, asthma, stroke, epilepsy, RA, antihypertensives, statins, corticosteroids, antiepileptics, benzodiazepines, HRT, bisphosphonates.|||1.54|0.08|
72548584|NCT01055223|144626586|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.99|||||TWO_SIDED|95.0|0.18|21.93|||||Unadjusted Odds Ratio. Reference group: TZD alone.|||21.93|0.18|
72548585|NCT01055223|144626586|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.05|||||TWO_SIDED|95.0|0.09|12.36|||||Adjusted Odds Ratio. Reference group TZD alone. Adjusted: age, liver disease, angina, renal and heart failure, asthma, stroke, epilepsy, RA, antihypertensives, statins, corticosteroids, antiepileptics, benzodiazepines, HRT, bisphosphonates.|||12.36|0.09|
72548586|NCT01055223|144626587|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.23|||||TWO_SIDED|95.0|0.8|1.88|||||Unadjusted Odds Ratio. Reference group: TZD alone.|||1.88|0.80|
72548587|NCT01055223|144626587|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.99|||||TWO_SIDED|95.0|0.62|1.57|||||Adjusted Odds Ratio. Reference group TZD alone. Adjusted: age, liver disease, angina, renal and heart failure, asthma, stroke, epilepsy, RA, antihypertensives, statins, corticosteroids, antiepileptics, benzodiazepines, HRT, bisphosphonates.|||1.57|0.62|
72548588|NCT01055223|144626587|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.0|||||TWO_SIDED|95.0|0.0|0.0|||||Unadjusted Odds Ratio. Small numbers model didn't converge. Reference group: TZD alone.|||0.00|0.00|
72548589|NCT01055223|144626587|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.0|||||TWO_SIDED|95.0|0.0|0.0|||||Small numbers model didn't converge. Ref grp: TZD alone. Adjusted: age, liver disease, angina, renal and heart failure, asthma, stroke, epilepsy, RA, antihypertensives, statins, corticosteroids, antiepileptics, benzodiazepines, HRT, bisphosphonates.|||0.00|0.00|
72548590|NCT01055223|144626587|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.0|||||TWO_SIDED|95.0|0.0|0.0|||||Unadjusted Odds Ratio. Small numbers model didn't converge. Reference group: TZD alone.|||0.00|0.00|
72548591|NCT01055223|144626587|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.0|||||TWO_SIDED|95.0|0.0|0.0|||||Small numbers model didn't converge. Ref grp: TZD alone. Adjusted: age, liver disease, angina, renal and heart failure, asthma, stroke, epilepsy, RA, antihypertensives, statins, corticosteroids, antiepileptics, benzodiazepines, HRT, bisphosphonates|||0.00|0.00|
72548592|NCT01055223|144626588|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.46|||||TWO_SIDED|95.0|1.53|19.45|||||Unadjusted Odds Ratio. Reference group: TZD alone.|||19.45|1.53|
72548593|NCT01055223|144626588|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.19|||||TWO_SIDED|95.0|0.64|15.86|||||Unadjusted Odds Ratio. Reference group TZD alone. Adjusted: age, liver disease, angina, renal and heart failure, asthma, stroke, epilepsy, RA, antihypertensives, statins, corticosteroids, antiepileptics, benzodiazepines, HRT, bisphosphonates.|||15.86|0.64|
72548594|NCT01055223|144626588|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.0|||||TWO_SIDED|95.0|0.0|0.0|||||Unadjusted Odds Ratio. Small numbers model didn't converge. Reference group: TZD alone.|||0.00|0.00|
72548595|NCT01055223|144626588|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.0|||||TWO_SIDED|95.0|0.0|0.0|||||Small numbers model didn't converge. Ref grp: TZD alone. Adjusted: age, liver disease, angina, renal and heart failure, asthma, stroke, epilepsy, RA, antihypertensives, statins, corticosteroids, antiepileptics, benzodiazepines, HRT, bisphosphonates.|||0.00|0.00|
72548596|NCT01055223|144626588|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.0|||||TWO_SIDED|95.0|0.0|0.0|||||Unadjusted Odds Ratio. Small numbers model didn't converge. Reference group: TZD alone.|||0.00|0.00|
72548597|NCT01055223|144626588|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.0|||||TWO_SIDED|95.0|0.0|0.0|||||Small numbers model didn't converge. Ref grp: TZD alone. Adjusted: age, liver disease, angina, renal and heart failure, asthma, stroke, epilepsy, RA, antihypertensives, statins, corticosteroids, antiepileptics, benzodiazepines, HRT, bisphosphonates.|||0.00|0.00|
72548598|NCT01055223|144626589|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|7.26|||||TWO_SIDED|95.0|0.66|80.35|||||Unadjusted Odds Ratio. Reference group: TZD alone.|||80.35|0.66|
72548599|NCT01055223|144626589|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.78|||||TWO_SIDED|95.0|0.03|96.47|||||Adjusted Odds Ratio. Reference group: TZD alone. Adjusted: age, liver disease, angina, renal and heart failure, asthma, stroke, epilepsy, RA, antihypertensives, statins, corticosteroids, antiepileptics, benzodiazepines, HRT, bisphosponates.|||96.47|0.03|
72548600|NCT01055223|144626589|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.0|||||TWO_SIDED|95.0|0.0|0.0|||||Unadjusted Odds Ratio. Small numbers model didn't converge. Reference Group: TZD alone.|||0.00|0.00|
72548601|NCT01055223|144626589|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.0|||||TWO_SIDED|95.0|0.0|0.0|||||Small numbers model didn't converge. Ref grp: TZD alone. Adjusted: age, liver disease, angina, renal and heart failure, asthma, stroke, epilepsy, RA, antihypertensives, statins, corticosteroids, antiepileptics, benzodiazepines, HRT, bisphosphonates.|||0.00|0.00|
72548602|NCT01055223|144626589|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.0|||||TWO_SIDED|95.0|0.0|0.0|||||Unadjusted Odds Ratio. Small numbers model didn't converge. Reference group: TZD alone.|||0.00|0.00|
72548603|NCT01055223|144626589|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.0|||||TWO_SIDED|95.0|0.0|0.0|||||Small numbers model didn't converge. Ref grp: TZD alone. Adjusted: age, liver disease, angina, renal and heart failure, asthma, stroke, epilepsy, RA, antihypertensives, statins, corticosteroids, antiepileptics, benzodiazepines, HRT, bisphosphonates.|||0.00|0.00|
72548604|NCT02579096|144626602|NON_INFERIORITY|A non-inferiority bound of 8% was established during the trial design; a one-sided alpha level was set at 0.05.|Risk Difference (RD)|-7.0|||<|0.001|ONE_SIDED|95.0||-1.2|||t-test, 1 sided|||One-sided null hypothesis posited that allopurinol was inferior to febuxostat. The proportions of participants with ≥ 1 gout flare during phase 3 were compared between the two treatments.||-1.2||<0.001
72548605|NCT02097121|144626603|SUPERIORITY||LS Mean Difference|-0.98|STANDARD_ERROR_OF_MEAN|1.107|=|0.3802|TWO_SIDED|95.0|-3.203|1.243|||ANCOVA|||"Treatment Difference of 100 U versus 25 U~Pairwise comparisons of 100 U versus 25 U of BOTOX up to Week 12 in Treatment Cycle 1 was evaluated using an ANCOVA model with study baseline value as covariate, and treatment group as factor. A hierarchical analysis strategy to adjust for multiplicity was used."||1.243|-3.203|= 0.3802
72548606|NCT02097121|144626603|SUPERIORITY||LS Mean Difference|0.4|STANDARD_ERROR_OF_MEAN|1.154|=|0.733|TWO_SIDED|95.0|-1.921|2.712|||ANCOVA|||"Treatment Difference of 50 U versus 25 U~Pairwise comparisons of 50 U versus 25 U of BOTOX up to Week 12 in Treatment Cycle 1 was evaluated using an ANCOVA model with study baseline value as covariate, and treatment group as factor. A hierarchical analysis strategy to adjust for multiplicity was used."||2.712|-1.921|= 0.733
72582143|NCT03593473|144694997|SUPERIORITY|||||||0.05|||||||Fisher's Z test|||Fisher's Z test for correlation between ACTH at +15 minutes and Cortisol at +28 minutes.||||0.05
72412514|NCT03029208|144333151|SUPERIORITY||LS mean difference|-0.23||||0.5619|TWO_SIDED|95.0|-3.17|2.7|||MMRM||SF-36 HRQoL MCS domain score was analyzed using an MMRM approach with an unstructured covariance matrix to compare the difference in LS means between arms at Week 52.|||2.70|-3.17|0.5619
72412515|NCT03029208|144333152|SUPERIORITY||LS mean difference|0.14||||0.4523|TWO_SIDED|95.0|-2.21|2.49|||MMRM||SF-36 HRQoL bodily pain domain score was analyzed using an MMRM approach with an unstructured covariance matrix to compare the difference in LS means between arms at Week 8.|||2.49|-2.21|0.4523
72412516|NCT03029208|144333152|SUPERIORITY||LS mean difference|-0.07||||0.5222|TWO_SIDED|95.0|-2.57|2.43|||MMRM||SF-36 HRQoL bodily pain domain score was analyzed using an MMRM approach with an unstructured covariance matrix to compare the difference in LS means between arms at Week 12.|||2.43|-2.57|0.5222
72582144|NCT03593473|144694997|SUPERIORITY|||||||0.1|||||||Fisher's Z test|||Fisher's Z test for correlation between ACTH at +28 minutes and Cortisol at +38 minutes.||||0.10
72582145|NCT03593473|144694997|SUPERIORITY|||||||0.9|||||||Fisher's Z test|||Fisher's Z test for correlation between ACTH at +38 minutes and Cortisol at +48 minutes.||||0.90
72582146|NCT03593473|144694997|SUPERIORITY|||||||0.21|||||||Mixed Models Analysis|||A mixed effects model with random intercept and slope was used to model cortisol at time j+1 as the outcome with ACTH at time j, study arm, and an interaction term between ACTH at time j and study arm as the exposure variables. The p-value presented below is for the interaction term between ACTH at time j and study arm.||||0.21
72582147|NCT03593473|144694998|SUPERIORITY|||||||0.8441|||||||t-test, 2 sided|||High frequency heart rate variability at minutes -40 to -35||||0.8441
72582148|NCT03593473|144694998|SUPERIORITY|||||||0.7919|||||||t-test, 2 sided|||High frequency heart rate variability at minutes -35 to -30||||0.7919
72582149|NCT03593473|144694998|SUPERIORITY|||||||0.5639|||||||t-test, 2 sided|||High frequency heart rate variability at minutes -30 to -25||||0.5639
72582150|NCT03593473|144694998|SUPERIORITY|||||||0.3139|||||||t-test, 2 sided|||High frequency heart rate variability at minutes -25 to -20||||0.3139
72582151|NCT03593473|144694998|SUPERIORITY|||||||0.4222|||||||t-test, 2 sided|||High frequency heart rate variability at minutes -20 to -15||||0.4222
72582152|NCT03593473|144694998|SUPERIORITY|||||||0.834|||||||t-test, 2 sided|||High frequency heart rate variability at minutes -15 to -10||||0.834
72582153|NCT03593473|144694998|SUPERIORITY|||||||0.7562|||||||t-test, 2 sided|||High frequency heart rate variability at minutes -10 to -5||||0.7562
72582154|NCT03593473|144694998|SUPERIORITY|||||||0.4245|||||||t-test, 2 sided|||High frequency heart rate variability at minutes -5 to 0||||0.4245
72582155|NCT03593473|144694998|SUPERIORITY|||||||0.1425|||||||t-test, 2 sided|||High frequency heart rate variability at minutes 5 to 8||||0.1425
72582156|NCT03593473|144694998|SUPERIORITY|||||||0.7175|||||||t-test, 2 sided|||High frequency heart rate variability at minutes 8 to 13||||0.7175
72582157|NCT03593473|144694998|SUPERIORITY|||||||0.1417|||||||t-test, 2 sided|||High frequency heart rate variability at minutes 13 to 18||||0.1417
72582158|NCT03593473|144694998|SUPERIORITY|||||||0.0514|||||||t-test, 2 sided|||High frequency heart rate variability at minutes 18 to 23||||0.0514
72582159|NCT03593473|144694998|SUPERIORITY|||||||0.1507|||||||t-test, 2 sided|||High frequency heart rate variability at minutes 23 to 28||||0.1507
72582160|NCT03593473|144694998|SUPERIORITY|||||||0.4204|||||||t-test, 2 sided|||High frequency heart rate variability at minutes 8 to 33||||0.4204
72582161|NCT03593473|144694998|SUPERIORITY|||||||0.4209|||||||t-test, 2 sided|||High frequency heart rate variability at minutes 33 to 38||||0.4209
72582162|NCT03593473|144694998|SUPERIORITY|||||||0.2569|||||||t-test, 2 sided|||High frequency heart rate variability at minutes 38 to 43||||0.2569
72582163|NCT03593473|144694998|SUPERIORITY|||||||0.0828|||||||t-test, 2 sided|||High frequency heart rate variability at minutes 43 to 48||||0.0828
72582164|NCT03593473|144694999|SUPERIORITY|||||||0.6452|||||||t-test, 2 sided|||Pre-ejection period at minutes -40 to -35||||0.6452
72582165|NCT03593473|144694999|SUPERIORITY|||||||0.3228|||||||t-test, 2 sided|||Pre-ejection period at minutes -35 to -30||||0.3228
72582166|NCT03593473|144694999|SUPERIORITY|||||||0.3541|||||||t-test, 2 sided|||Pre-ejection period at minutes -30 to -25||||0.3541
72582167|NCT03593473|144694999|SUPERIORITY|||||||0.4311|||||||t-test, 2 sided|||Pre-ejection period at minutes -25 to -20||||0.4311
72582168|NCT03593473|144694999|SUPERIORITY|||||||0.3349|||||||t-test, 2 sided|||Pre-ejection period at minutes -20 to -15||||0.3349
72582169|NCT03593473|144694999|SUPERIORITY|||||||0.2646|||||||t-test, 2 sided|||Pre-ejection period at minutes -15 to -10||||0.2646
72582170|NCT03593473|144694999|SUPERIORITY|||||||0.1095|||||||t-test, 2 sided|||Pre-ejection period at minutes -10 to -5||||0.1095
72582171|NCT03593473|144694999|SUPERIORITY|||||||0.0194|||||||t-test, 2 sided|||Pre-ejection period at minutes -5 to 0||||0.0194
72582172|NCT03593473|144694999|SUPERIORITY|||||||0.473|||||||t-test, 2 sided|||Pre-ejection period at minutes 5 to 8||||0.473
72582173|NCT03593473|144694999|SUPERIORITY|||||||0.5768|||||||t-test, 2 sided|||Pre-ejection period at minutes 8 to 13||||0.5768
72582174|NCT03593473|144694999|SUPERIORITY|||||||0.3477|||||||t-test, 2 sided|||Pre-ejection period at minutes 13 to 18||||0.3477
72582175|NCT03593473|144694999|SUPERIORITY|||||||0.1413|||||||t-test, 2 sided|||Pre-ejection period at minutes 18 to 23||||0.1413
72582176|NCT03593473|144694999|SUPERIORITY|||||||0.2128|||||||t-test, 2 sided|||Pre-ejection period at minutes 23 to 28||||0.2128
72582177|NCT03593473|144694999|SUPERIORITY|||||||0.1415|||||||t-test, 2 sided|||Pre-ejection period at minutes 28 to 33||||0.1415
72582178|NCT03593473|144694999|SUPERIORITY|||||||0.1126|||||||t-test, 2 sided|||Pre-ejection period at minutes 33 to 38||||0.1126
72582179|NCT03593473|144694999|SUPERIORITY|||||||0.1647|||||||t-test, 2 sided|||Pre-ejection period at minutes 38 to 43||||0.1647
72412517|NCT03029208|144333152|SUPERIORITY||LS mean difference|2.33||||0.044|TWO_SIDED|95.0|-0.35|5.02|||MMRM||SF-36 HRQoL bodily pain domain score was analyzed using an MMRM approach with an unstructured covariance matrix to compare the difference in LS means between arms at Week 28.|||5.02|-0.35|0.0440
72412518|NCT03029208|144333152|SUPERIORITY||LS mean difference|-2.61||||0.9523|TWO_SIDED|95.0|-5.68|0.46|||MMRM||SF-36 HRQoL bodily pain domain score was analyzed using an MMRM approach with an unstructured covariance matrix to compare the difference in LS means between arms at Week 52.|||0.46|-5.68|0.9523
72582180|NCT03593473|144694999|SUPERIORITY|||||||0.088|||||||t-test, 2 sided|||Pre-ejection period at minutes 43 to 48||||0.088
72582181|NCT01415518|144695018|SUPERIORITY_OR_OTHER||Ratio|1.069|||<|0.0001|TWO_SIDED|95.0|1.043|1.096|||ANCOVA|multiplicative ANCOVA model with treatment and centre as fixed factors and baseline value as a (log-transformed) covariate||||1.096|1.043|<.0001
72412519|NCT03029208|144333152|SUPERIORITY||LS mean difference|0.05||||0.4811|TWO_SIDED|95.0|-1.82|1.91|||MMRM||SF-36 HRQoL general health domain score was analyzed using an MMRM approach with an unstructured covariance matrix to compare the difference in LS means between arms at Week 8.|||1.91|-1.82|0.4811
72582182|NCT01415518|144695019|SUPERIORITY_OR_OTHER||Ratio|1.067|||<|0.0001|TWO_SIDED|95.0|1.044|1.09|||ANCOVA|Multiplicative ANCOVA model with treatment and centre as fixed factors and baseline value as a (log-transformed) covariate||||1.090|1.044|<.0001
72582183|NCT01415518|144695020|SUPERIORITY_OR_OTHER||Ratio|1.068|||<|0.0001||95.0|1.043|1.092|||ANCOVA|Multiplicative ANCOVA model with treatment and centre as fixed factors and baseline value as a (log-transformed) covariate||||1.092|1.043|<.0001
72412520|NCT03029208|144333152|SUPERIORITY||LS mean difference|0.28||||0.3834|TWO_SIDED|95.0|-1.56|2.11|||MMRM||SF-36 HRQoL general health domain score was analyzed using an MMRM approach with an unstructured covariance matrix to compare the difference in LS means between arms at Week 12.|||2.11|-1.56|0.3834
72582184|NCT01415518|144695021|SUPERIORITY_OR_OTHER||Ratio|1.04||||0.0007|TWO_SIDED|95.0|1.017|1.064|||ANCOVA|Multiplicative ANCOVA model with treatment and centre as fixed factors and baseline value as a (log-transformed) covariate||||1.064|1.017|0.0007
72582185|NCT01415518|144695022|SUPERIORITY_OR_OTHER||Ratio|1.045|||<|0.0001|TWO_SIDED|95.0|1.024|1.065|||ANCOVA|Multiplicative ANCOVA model with treatment and centre as fixed factors and baseline value as a (log-transformed) covariate||||1.065|1.024|<.0001
72582186|NCT01415518|144695023|SUPERIORITY_OR_OTHER||Ratio|1.038||||0.0003|TWO_SIDED|95.0|1.017|1.06|||ANCOVA|Multiplicative ANCOVA model with treatment and centre as fixed factors and baseline value as a (log-transformed) covariate||||1.060|1.017|0.0003
72582187|NCT01415518|144695024|SUPERIORITY_OR_OTHER||Ratio|1.035||||0.0248|TWO_SIDED|95.0|1.004|1.066|||ANCOVA|Multiplicative ANCOVA model with treatment and centre as fixed factors and baseline value as a (log-transformed) covariate||||1.066|1.004|0.0248
72412521|NCT03029208|144333152|SUPERIORITY||LS mean difference|0.26||||0.3983|TWO_SIDED|95.0|-1.72|2.24|||MMRM||SF-36 HRQoL general health domain score was analyzed using an MMRM approach with an unstructured covariance matrix to compare the difference in LS means between arms at Week 28.|||2.24|-1.72|0.3983
72582188|NCT01415518|144695025|SUPERIORITY_OR_OTHER||Ratio|1.038||||0.0074|TWO_SIDED|95.0|1.01|1.067|||ANCOVA|Multiplicative ANCOVA model with treatment and centre as fixed factors and baseline value as a (log-transformed) covariate||||1.067|1.010|0.0074
72582189|NCT01415518|144695026|SUPERIORITY_OR_OTHER||Mean Difference (Net)|25.172||||0.0001|TWO_SIDED|95.0|12.733|37.611|||ANCOVA|Additive ANCOVA model with treatment and centre as fixed factors and the run-in mean of pre-dose morning PEF as a covariate||||37.611|12.733|0.0001
72582190|NCT01415518|144695027|SUPERIORITY_OR_OTHER||Mean Difference (Net)|21.136|||<|0.0001|TWO_SIDED|95.0|12.163|30.11|||ANCOVA|Additive ANCOVA model with treatment and centre as fixed factors and the run-in mean of pre-dose morning PEF as a covariate||||30.110|12.163|<.0001
72582191|NCT01415518|144695028|SUPERIORITY_OR_OTHER||Mean Difference (Net)|23.044|||<|0.0001|TWO_SIDED|95.0|14.927|31.161|||ANCOVA|Additive ANCOVA model with treatment and centre as fixed factors and the run-in mean of pre-dose morning PEF as a covariate||||31.161|14.927|<.0001
72582192|NCT01415518|144695029|SUPERIORITY_OR_OTHER||Mean Difference (Net)|31.513|||<|0.0001|TWO_SIDED|95.0|18.74|44.286|||ANCOVA|Additive ANCOVA model with treatment and centre as fixed factors and the run-in mean of pre-dose morning PEF as a covariate||||44.286|18.740|<.0001
72582193|NCT01415518|144695030|SUPERIORITY_OR_OTHER||Mean Difference (Net)|24.322|||<|0.0001|TWO_SIDED|95.0|14.425|34.22|||ANCOVA|Additive ANCOVA model with treatment and centre as fixed factors and the run-in mean of pre-dose morning PEF as a covariate||||34.220|14.425|<.0001
72582194|NCT01415518|144695031|SUPERIORITY_OR_OTHER||Mean Difference (Net)|27.168|||<|0.0001|TWO_SIDED|95.0|18.906|35.431|||ANCOVA|Additive ANCOVA model with treatment and centre as fixed factors and the run-in mean of pre-dose morning PEF as a covariate||||35.431|18.906|<.0001
72582195|NCT01415518|144695032|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.297||||0.0102|TWO_SIDED|95.0|-0.522|-0.071|||ANCOVA|Additive ANCOVA model with treatment and centre as fixed factors and the run-in mean of reliever medication as a covariate||||-0.071|-0.522|0.0102
72582196|NCT01415518|144695033|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.343||||0.0004|TWO_SIDED|95.0|-0.533|-0.153|||ANCOVA|Additive ANCOVA model with treatment and centre as fixed factors and the run-in mean of reliever medication as a covariate||||-0.153|-0.533|0.0004
72582197|NCT01415518|144695034|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.342||||0.0002|TWO_SIDED|95.0|-0.523|-0.162|||ANCOVA|Additive ANCOVA model with treatment and centre as fixed factors and the run-in mean of reliever medication as a covariate||||-0.162|-0.523|0.0002
72582198|NCT01415518|144695035|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.279|||<|0.0001|TWO_SIDED|95.0|-0.381|-0.177|||ANCOVA|Additive ANCOVA model with treatment and centre as fixed factors and the run-in mean of score as a covariate||||-0.177|-0.381|<.0001
72582199|NCT01415518|144695036|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.193||||0.0002|TWO_SIDED|95.0|-0.294|-0.092|||ANCOVA|Additive ANCOVA model with treatment and centre as fixed factors and the run-in mean of score as a covariate||||-0.092|-0.294|0.0002
72582200|NCT01415518|144695037|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.208||||0.0001|TWO_SIDED|95.0|-0.308|-0.108|||ANCOVA|Additive ANCOVA model with treatment and centre as fixed factors and the run-in mean of score as a covariate||||-0.108|-0.308|0.0001
72582201|NCT01415518|144695038|SUPERIORITY_OR_OTHER||Rate ratio|0.565||||0.0425|TWO_SIDED|95.0|0.325|0.981|||Poisson regression|Poisson regression model with treatment as a factor and the duration time in study as an offset variable||||0.981|0.325|0.0425
72582202|NCT01415518|144695038|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.604||||0.088|TWO_SIDED|95.0|0.339|1.078|||Regression, Cox|Time to the first COPD exacerbation||||1.078|0.339|0.0880
72582203|NCT01415518|144695038|SUPERIORITY_OR_OTHER|||||||0.0845|||||||Log Rank|Time to the first COPD exacerbation||||||0.0845
72582204|NCT01415518|144695039|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.055||||0.2281|TWO_SIDED|95.0|-0.144|0.035|||ANCOVA|Additive ANCOVA model with treatment and centre as fixed factors and the run-in mean of reliever medication as a covariate||||0.035|-0.144|0.2281
72582205|NCT01415518|144695040|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.122||||0.001|TWO_SIDED|95.0|-0.194|-0.049|||ANCOVA|Additive ANCOVA model with treatment and centre as fixed factors and the run-in mean of reliever medication as a covariate||||-0.049|-0.194|0.0010
72582206|NCT01415518|144695041|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.106||||0.0073|TWO_SIDED|95.0|-0.183|-0.029|||ANCOVA|Additive ANCOVA model with treatment and centre as fixed factors and the run-in mean of reliever medication as a covariate||||-0.029|-0.183|0.0073
72582207|NCT01730053|144695050|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-34.2|||<|0.0001|TWO_SIDED|98.75|-49.2|-19.3||Threshold for significance ≤ 0.0125.|Mixed Models Analysis|||Alirocumab group was compared to the corresponding active control group using an appropriate contrast statement.||-19.3|-49.2|<0.0001
72582208|NCT01730053|144695050|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-36.1|||<|0.0001|TWO_SIDED|98.75|-51.5|-20.7||Threshold for significance ≤ 0.0125.|Mixed Models Analysis|||As described in statistical analysis 1 of the endpoint.||-20.7|-51.5|<0.0001
72582209|NCT01730053|144695050|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-20.3|||=|0.0453|TWO_SIDED|98.75|-45.8|5.1||Threshold for significance ≤ 0.0125.|Mixed Models Analysis|||As described in statistical analysis 1 of the endpoint.||5.1|-45.8|=0.0453
72582210|NCT01730053|144695050|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-25.3|||=|0.0136|TWO_SIDED|98.75|-50.9|0.3||Threshold for significance ≤ 0.0125.|Mixed Models Analysis|||As described in statistical analysis 1 of the endpoint.||0.3|-50.9|=0.0136
72412522|NCT03029208|144333152|SUPERIORITY||LS mean difference|-0.18||||0.5617|TWO_SIDED|95.0|-2.51|2.15|||MMRM||SF-36 HRQoL general health domain score was analyzed using an MMRM approach with an unstructured covariance matrix to compare the difference in LS means between arms at Week 52.|||2.15|-2.51|0.5617
72582211|NCT01730053|144695051|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-35.2|||<|0.0001|TWO_SIDED|98.75|-47.4|-23.0||Threshold for significance ≤ 0.0125.|Mixed Models Analysis|||A hierarchical testing procedure was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when previous endpoint was statistically significant at 1.25 % level.||-23.0|-47.4|<0.0001
72582212|NCT01730053|144695051|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-33.2|||<|0.0001|TWO_SIDED|98.75|-45.9|-20.5||Threshold for significance ≤ 0.0125.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-20.5|-45.9|<0.0001
72582213|NCT01730053|144695051|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-24.5|||=|0.0131|TWO_SIDED|98.75|-49.2|0.2||Threshold for significance ≤ 0.0125.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||0.2|-49.2|=0.0131
72582214|NCT01730053|144695052|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-35.2|||<|0.0001|TWO_SIDED|98.75|-47.4|-17.9||Threshold for significance ≤ 0.0125.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant for rosuvastatin 10 mg baseline stratification).||-17.9|-47.4|<0.0001
72582215|NCT01730053|144695052|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-32.2|||<|0.0001|TWO_SIDED|98.75|-47.0|-17.5||Threshold for significance ≤ 0.0125.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-17.5|-47|<0.0001
72582216|NCT01730053|144695053|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-35.3|||<|0.0001|TWO_SIDED|98.75|-48.2|-22.5||Threshold for significance ≤ 0.0125.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant for rosuvastatin 10 mg baseline stratification).||-22.5|-48.2|<0.0001
72582217|NCT01730053|144695053|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-32.3|||<|0.0001|TWO_SIDED|98.75|-45.6|-19.0||Threshold for significance ≤ 0.0125.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-19.0|-45.6|<0.0001
72582218|NCT01730053|144695054|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-29.2|||<|0.0001|TWO_SIDED|98.75|-40.1|-18.3||Threshold for significance ≤ 0.0125.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant for rosuvastatin 10 mg baseline stratification).||-18.3|-40.1|<0.0001
72582219|NCT01730053|144695054|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-26.8|||<|0.0001|TWO_SIDED|98.75|-37.9|-15.7||Threshold for significance ≤ 0.0125.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-15.7|-37.9|<0.0001
72582220|NCT01730053|144695055|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-30.7|||<|0.0001|TWO_SIDED|98.75|-40.1|-21.3||Threshold for significance ≤ 0.0125.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant for rosuvastatin 10 mg baseline stratification).||-21.3|-40.1|<0.0001
72582221|NCT01730053|144695055|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-28.3|||<|0.0001|TWO_SIDED|98.75|-38.0|-18.7||Threshold for significance ≤ 0.0125.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-18.7|-38.0|<0.0001
72582222|NCT01730053|144695056|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-31.4|||<|0.0001|TWO_SIDED|98.75|-43.9|-18.9||Threshold for significance ≤ 0.0125.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant for rosuvastatin 10 mg baseline stratification).||-18.9|-43.9|<0.0001
72582223|NCT01730053|144695056|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-29.3|||<|0.0001|TWO_SIDED|98.75|-42.1|-16.4||Threshold for significance ≤ 0.0125.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-16.4|-42.1|<0.0001
72582224|NCT01730053|144695057|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-32.8|||<|0.0001|TWO_SIDED|98.75|-43.2|-22.4||Threshold for significance ≤ 0.0125.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant for rosuvastatin 10 mg baseline stratification).||-22.4|-43.2|<0.0001
72582225|NCT01730053|144695057|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-28.2|||<|0.0001|TWO_SIDED|98.75|-39.1|-17.3||Threshold for significance ≤ 0.0125.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-17.3|-39.1|<0.0001
72582226|NCT01730053|144695058|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-20.6|||<|0.0001|TWO_SIDED|98.75|-29.4|-11.8||Threshold for significance ≤ 0.0125.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant for rosuvastatin 10 mg baseline stratification).||-11.8|-29.4|<0.0001
72582227|NCT01730053|144695058|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-20.3|||<|0.0001|TWO_SIDED|98.75|-29.3|-11.2||Threshold for significance ≤ 0.0125.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-11.2|-29.3|<0.0001
72582228|NCT01730053|144695059|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-28.1|||<|0.0001|TWO_SIDED|98.75|-39.7|-16.5||Threshold for significance ≤ 0.0125.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant for rosuvastatin 10 mg baseline stratification).||-16.5|-39.7|<0.0001
72582229|NCT01730053|144695059|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-24.0|||<|0.0001|TWO_SIDED|98.75|-35.7|-12.3||Threshold for significance ≤ 0.0125.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-12.3|-35.7|<0.0001
72582230|NCT01730053|144695060|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-29.5|||<|0.0001|TWO_SIDED|98.75|-42.1|-16.9||Threshold for significance ≤ 0.0125.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant for rosuvastatin 10 mg baseline stratification).||-16.9|-42.1|<0.0001
72582231|NCT01730053|144695060|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-24.9|||<|0.0001|TWO_SIDED|98.75|-37.7|-12.2||Threshold for significance ≤ 0.0125.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-12.2|-37.7|<0.0001
72548607|NCT02097121|144626604|SUPERIORITY||LS Mean Difference|0.82|STANDARD_ERROR_OF_MEAN|1.442|=|0.5743|TWO_SIDED|95.0|-2.082|3.713|||ANCOVA|||"Treatment Difference of 100 U versus 25 U~Pairwise comparisons of 100 U versus 25 U of BOTOX up to Week 12 in Treatment Cycle 1 was evaluated using an ANCOVA model with study baseline value as covariate, and treatment group and stratification (baseline daytime urinary urgency incontinence episodes \[a total of ≤ 6 episodes or \> 6 episodes over the 2-day diary collection period\]) as factors. A hierarchical analysis strategy to adjust for multiplicity was not implemented."||3.713|-2.082|= 0.5743
72548608|NCT02097121|144626604|SUPERIORITY||LS Mean Difference|2.15|STANDARD_ERROR_OF_MEAN|1.455|=|0.1451|TWO_SIDED|95.0|-0.769|5.078|||ANCOVA|||"Treatment Difference of 50 U versus 25 U~Pairwise comparisons of 50 U versus 25 U of BOTOX up to Week 12 in Treatment Cycle 1 was evaluated using an ANCOVA model with study baseline value as covariate, and treatment group and stratification (baseline daytime urinary urgency incontinence episodes \[a total of ≤ 6 episodes or \> 6 episodes over the 2-day diary collection period\]) as factors. A hierarchical analysis strategy to adjust for multiplicity was not implemented."||5.078|-0.769|= 0.1451
72548609|NCT02097121|144626605|SUPERIORITY||LS Mean Difference|-0.33|STANDARD_ERROR_OF_MEAN|1.434|=|0.8206|TWO_SIDED|95.0|-3.205|2.551|||ANCOVA|||"Treatment Difference of 100 U versus 25 U~Pairwise comparisons of 100 U versus 25 U of BOTOX up to Week 12 in Treatment Cycle 1 was evaluated using an ANCOVA model with study baseline value as covariate, and treatment group and stratification (baseline daytime urinary urgency incontinence episodes \[a total of ≤ 6 episodes or \> 6 episodes over the 2-day diary collection period\]) as factors. A hierarchical analysis strategy to adjust for multiplicity was not implemented."||2.551|-3.205|= 0.8206
72548610|NCT02097121|144626605|SUPERIORITY||LS Mean Difference|0.07|STANDARD_ERROR_OF_MEAN|1.434|=|0.9604|TWO_SIDED|95.0|-2.807|2.95|||ANCOVA|||"Treatment Difference of 50 U versus 25 U~Pairwise comparisons of 50 U versus 25 U of BOTOX up to Week 12 in Treatment Cycle 1 was evaluated using an ANCOVA model with study baseline value as covariate, and treatment group and stratification (baseline daytime urinary urgency incontinence episodes \[a total of ≤ 6 episodes or \> 6 episodes over the 2-day diary collection period\]) as factors. A hierarchical analysis strategy to adjust for multiplicity was not implemented."||2.95|-2.807|= 0.9604
72548611|NCT02097121|144626607|SUPERIORITY||LS Mean Difference|35.33|STANDARD_ERROR_OF_MEAN|22.175|=|0.1174|TWO_SIDED|95.0|-9.207|79.873|||ANCOVA|||"Treatment Difference of 100 U versus 25 U~Pairwise comparisons of 100 U versus 25 U of BOTOX up to Week 12 in Treatment Cycle 1 was evaluated using an ANCOVA model with study baseline value as covariate, and treatment group and stratification (baseline daytime urinary urgency incontinence episodes \[a total of ≤ 6 episodes or \> 6 episodes over the 2-day diary collection period\]) as factors. A hierarchical analysis strategy to adjust for multiplicity was not implemented."||79.873|-9.207|= 0.1174
72548612|NCT02097121|144626607|SUPERIORITY||LS Mean Difference|34.11|STANDARD_ERROR_OF_MEAN|23.722|=|0.1567|TWO_SIDED|95.0|-13.536|81.76|||ANCOVA|||"Treatment Difference of 50 U versus 25 U~Pairwise comparisons of 50 U versus 25 U of BOTOX up to Week 12 in Treatment Cycle 1 was evaluated using an ANCOVA model with study baseline value as covariate, and treatment group and stratification (baseline daytime urinary urgency incontinence episodes \[a total of ≤ 6 episodes or \> 6 episodes over the 2-day diary collection period\]) as factors. A hierarchical analysis strategy to adjust for multiplicity was not implemented."||81.76|-13.536|= 0.1567
72548613|NCT02097121|144626608|SUPERIORITY||LS Mean Difference|-1.32|STANDARD_ERROR_OF_MEAN|4.091|=|0.7481|TWO_SIDED|95.0|-9.553|6.909|||ANCOVA|||"Treatment Difference of 100 U versus 25 U~Pairwise comparisons of 100 U versus 25 U of BOTOX up to Week 12 in Treatment Cycle 1 was evaluated using an ANCOVA model with study baseline value as covariate, and treatment group and stratification (baseline daytime urinary urgency incontinence episodes \[a total of ≤ 6 episodes or \> 6 episodes over the 2-day diary collection period\]) as factors. A hierarchical analysis strategy to adjust for multiplicity was not implemented."||6.909|-9.553|= 0.7481
72548614|NCT02097121|144626608|SUPERIORITY||LS Mean Difference|1.85|STANDARD_ERROR_OF_MEAN|4.299|=|0.6691|TWO_SIDED|95.0|-6.799|10.498|||ANCOVA|||"Treatment Difference of 50 U versus 25 U~Pairwise comparisons of 50 U versus 25 U of BOTOX up to Week 12 in Treatment Cycle 1 was evaluated using an ANCOVA model with study baseline value as covariate, and treatment group and stratification (baseline daytime urinary urgency incontinence episodes \[a total of ≤ 6 episodes or \> 6 episodes over the 2-day diary collection period\]) as factors. A hierarchical analysis strategy to adjust for multiplicity was not implemented."||10.498|-6.799|= 0.6691
72548615|NCT02097121|144626609|SUPERIORITY||LS Mean Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.343|=|0.9297|TWO_SIDED|95.0|-0.721|0.661|||ANCOVA|||"Treatment Difference of 100 U versus 25 U~Pairwise comparisons of 100 U versus 25 U of BOTOX up to Week 12 in Treatment Cycle 1 was evaluated using an ANCOVA model with study baseline value as covariate, and treatment group and stratification (baseline daytime urinary urgency incontinence episodes \[a total of ≤ 6 episodes or \> 6 episodes over the 2-day diary collection period\]) as factors. A hierarchical analysis strategy to adjust for multiplicity was not implemented."||0.661|-0.721|= 0.9297
72548616|NCT02097121|144626609|SUPERIORITY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.357|=|0.3976|TWO_SIDED|95.0|-1.022|0.413|||ANCOVA|||Pairwise comparisons of 50 U versus 25 U of BOTOX up to Week 12 in Treatment Cycle 1 was evaluated using an ANCOVA model with study baseline value as covariate, and treatment group and stratification (baseline daytime urinary urgency incontinence episodes \[a total of ≤ 6 episodes or \> 6 episodes over the 2-day diary collection period\]) as factors. A hierarchical analysis strategy to adjust for multiplicity was not implemented.||0.413|-1.022|= 0.3976
72582232|NCT01730053|144695061|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-20.1|||<|0.0001|TWO_SIDED|98.75|-29.4|-10.7||Threshold for significance ≤ 0.0125.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant for rosuvastatin 10 mg baseline stratification).||-10.7|-29.4|<0.0001
72582233|NCT01730053|144695061|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-17.2|||<|0.0001|TWO_SIDED|98.75|-26.7|-7.7||Threshold for significance ≤ 0.0125.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-7.7|-26.7|<0.0001
72582234|NCT01730053|144695062|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|12.4|||<|0.0001|TWO_SIDED|98.75|2.6|59.5||Threshold for significance ≤ 0.0125.|Regression, Logistic|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant for rosuvastatin 10 mg baseline stratification). Statistical analysis used a multiple imputation approach followed by a Logistic regression model.||59.5|2.6|<0.0001
72582235|NCT01730053|144695062|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|8.4|||=|0.0007|TWO_SIDED|98.75|1.8|40.5||Threshold for significance ≤ 0.0125.|Regression, Logistic|||Analysis description as per the statistical analysis 1 of this endpoint.||40.5|1.8|=0.0007
72582236|NCT01730053|144695063|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|15.6|||<|0.0001|TWO_SIDED|98.75|2.58|88.2||Threshold for significance ≤ 0.0125.|Regression, Logistic|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant for rosuvastatin 10 mg baseline stratification). Statistical analysis used a multiple imputation approach followed by a Logistic regression model.||88.2|2.58|<0.0001
72582237|NCT01730053|144695063|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|9.9|||=|0.001|TWO_SIDED|98.75|1.7|56.7||Threshold for significance ≤ 0.0125.|Regression, Logistic|||Analysis description as per the statistical analysis 1 of this endpoint.||56.7|1.7|=0.001
72582238|NCT01730053|144695064|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|18.6|||<|0.0001|TWO_SIDED|98.75|3.6|96.2||Threshold for significance ≤ 0.0125.|Regression, Logistic|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant for rosuvastatin 10 mg baseline stratification). Statistical analysis used a multiple imputation approach followed by a Logistic regression model.||96.2|3.6|<0.0001
72582239|NCT01730053|144695064|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|11.6|||<|0.0001|TWO_SIDED|98.75|2.5|53.1||Threshold for significance ≤ 0.0125.|Regression, Logistic|||Analysis description as per the statistical analysis 1 of this endpoint.||53.1|2.5|<0.0001
72582240|NCT01730053|144695065|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|20.3|||<|0.0001|TWO_SIDED|98.75|2.4|67.7||Threshold for significance ≤ 0.0125.|Regression, Logistic|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant for rosuvastatin 10 mg baseline stratification). Statistical analysis used a multiple imputation approach followed by a Logistic regression model.||67.7|2.4|<0.0001
72582241|NCT01730053|144695065|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|12.7|||=|0.0002|TWO_SIDED|98.75|2.4|67.7||Threshold for significance ≤ 0.0125.|Regression, Logistic|||Analysis description as per the statistical analysis 1 of this endpoint.||67.7|2.4|=0.0002
72582242|NCT01730053|144695066|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Mean Difference|-23.9|||<|0.0001|TWO_SIDED|98.75|-38.6|-9.1||Threshold for significance ≤ 0.0125.|Regression, Robust|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant for rosuvastatin 10 mg baseline stratification). Statistical analysis used a multiple imputation approach followed by a robust regression model.||-9.1|-38.6|<0.0001
72582243|NCT01730053|144695066|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Mean Difference|-23.6|||=|0.0001|TWO_SIDED|98.75|-39.0|-8.2||Threshold for significance ≤ 0.0125.|Regression, Robust|||Analysis description as per the statistical analysis 1 of this endpoint.||-8.2|-39.0|=0.0001
72582244|NCT01730053|144695067|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|7.4|||=|0.0311|TWO_SIDED|98.75|-1.2|16.1||Threshold for significance ≤ 0.0125.|Regression, Robust|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant for rosuvastatin 10 mg baseline stratification). Statistical analysis used a multiple imputation approach followed by a robust regression model.||16.1|-1.2|=0.0311
72582245|NCT05085834|144695084|OTHER|Generalized estimating equations were used while adjusting for age and sex, and examining interactions between time and treatment. Combining linear coefficients in the equation while accounting for the multiplicative effects of treatment and time were considered to assess the true effect size of zinc supplementation on biomarkers.|β coefficient|0.71|STANDARD_ERROR_OF_MEAN|0.14|<|0.01|TWO_SIDED|95.0|0.43|0.98|||linear combination of coefficients|||effect of Zinc supplementation on ln(Zinc, μg/dL)||0.98|0.43|<0.01
72582246|NCT05085834|144695085|OTHER|Generalized estimating equations were used while adjusting for age and sex, and examining interactions between time and treatment. Combining linear coefficients in the equation while accounting for the multiplicative effects of treatment and time were considered to assess the true effect size of zinc supplementation on biomarkers.|β coefficient|-0.002|STANDARD_ERROR_OF_MEAN|0.29||1|TWO_SIDED|95.0|-0.57|0.57|||linear combination of coefficients|||effect of Zinc supplementation on ln(hsCRP ng/mL)||0.57|-0.57|1.00
72582247|NCT05085834|144695085|OTHER|Generalized estimating equations were used while adjusting for age and sex, and examining interactions between time and treatment. Combining linear coefficients in the equation while accounting for the multiplicative effects of treatment and time were considered to assess the true effect size of zinc supplementation on biomarkers.|β coefficient|-0.08|STANDARD_ERROR_OF_MEAN|0.05||0.08|TWO_SIDED|95.0|-0.18|0.01|||linear combination of coefficients|||effect of Zinc supplementation on ln(sCD14, ng/mL)||0.01|-0.18|0.08
72582248|NCT05085834|144695085|OTHER|Generalized estimating equations were used while adjusting for age and sex, and examining interactions between time and treatment. Combining linear coefficients in the equation while accounting for the multiplicative effects of treatment and time were considered to assess the true effect size of zinc supplementation on biomarkers.|β coefficient|-0.03|STANDARD_ERROR_OF_MEAN|0.09||0.77|TWO_SIDED|95.0|-0.21|0.15|||linear combination of coefficients|||effect of Zinc supplementation on ln(sCD163, ng/mL)||0.15|-0.21|0.77
72582249|NCT05085834|144695085|OTHER|Generalized estimating equations were used while adjusting for age and sex, and examining interactions between time and treatment. Combining linear coefficients in the equation while accounting for the multiplicative effects of treatment and time were considered to assess the true effect size of zinc supplementation on biomarkers.|β coefficient|0.2|STANDARD_ERROR_OF_MEAN|0.15||0.19|TWO_SIDED|95.0|-0.1|0.5|||linear combination of coefficients|||effect of Zinc supplementation on ln(D-dimer, ng/mL)||0.50|-0.10|0.19
72582250|NCT05085834|144695085|OTHER|Generalized estimating equations were used while adjusting for age and sex, and examining interactions between time and treatment. Combining linear coefficients in the equation while accounting for the multiplicative effects of treatment and time were considered to assess the true effect size of zinc supplementation on biomarkers.|β coefficient|-0.19|STANDARD_ERROR_OF_MEAN|0.11||0.1|TWO_SIDED|95.0|-0.41|0.04|||linear combination of coefficients|||effect of Zinc supplementation on ln(VCAM, ng/mL)||0.04|-0.41|0.10
72412523|NCT03029208|144333152|SUPERIORITY||LS mean difference|-1.15||||0.8336|TWO_SIDED|95.0|-3.48|1.18|||MMRM||SF-36 HRQoL mental health domain score was analyzed using an MMRM approach with an unstructured covariance matrix to compare the difference in LS means between arms at Week 8.|||1.18|-3.48|0.8336
72412524|NCT03029208|144333152|SUPERIORITY||LS mean difference|-1.41||||0.9188|TWO_SIDED|95.0|-3.4|0.57|||MMRM||SF-36 HRQoL mental health domain score was analyzed using an MMRM approach with an unstructured covariance matrix to compare the difference in LS means between arms at Week 12.|||0.57|-3.40|0.9188
72548617|NCT02097121|144626610|SUPERIORITY||LS Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|0.302|=|0.3309|TWO_SIDED|95.0|-0.311|0.904|||ANCOVA|||"Treatment Difference of 100 U versus 25 U~Pairwise comparisons of 100 U versus 25 U of BOTOX up to Week 12 in Treatment Cycle 1 was evaluated using an ANCOVA model with study baseline value as covariate, and treatment group and stratification (baseline daytime urinary urgency incontinence episodes \[a total of ≤ 6 episodes or \> 6 episodes over the 2-day diary collection period\]) as factors. A hierarchical analysis strategy to adjust for multiplicity was not implemented."||0.904|-0.311|= 0.3309
72548618|NCT02097121|144626610|SUPERIORITY||LS Mean Difference|0.39|STANDARD_ERROR_OF_MEAN|0.315|=|0.2235|TWO_SIDED|95.0|-0.245|1.024|||ANCOVA|||"Treatment Difference of 50 U versus 25 U~Pairwise comparisons of 50 U versus 25 U of BOTOX up to Week 12 in Treatment Cycle 1 was evaluated using an ANCOVA model with study baseline value as covariate, and treatment group and stratification (baseline daytime urinary urgency incontinence episodes \[a total of ≤ 6 episodes or \> 6 episodes over the 2-day diary collection period\]) as factors. A hierarchical analysis strategy to adjust for multiplicity was not implemented."||1.024|-0.245|= 0.2235
72548619|NCT02097121|144626611|SUPERIORITY||LS Mean Difference|0.12|STANDARD_ERROR_OF_MEAN|0.274|=|0.6689|TWO_SIDED|95.0|-0.434|0.67|||ANCOVA|||"Treatment Difference of 100 U versus 25 U~Pairwise comparisons of 100 U versus 25 U of BOTOX up to Week 12 in Treatment Cycle 1 was evaluated using an ANCOVA model with study baseline value as covariate, and treatment group and stratification (baseline daytime urinary urgency incontinence episodes \[a total of ≤ 6 episodes or \> 6 episodes over the 2-day diary collection period\]) as factors. A hierarchical analysis strategy to adjust for multiplicity was not implemented."||0.67|-0.434|= 0.6689
72548620|NCT02097121|144626611|SUPERIORITY||LS Mean Difference|0.15|STANDARD_ERROR_OF_MEAN|0.288|=|0.6076|TWO_SIDED|95.0|-0.431|0.729|||ANCOVA|||"Treatment Difference of 50 U versus 25 U~Pairwise comparisons of 50 U versus 25 U of BOTOX up to Week 12 in Treatment Cycle 1 was evaluated using an ANCOVA model with study baseline value as covariate, and treatment group and stratification (baseline daytime urinary urgency incontinence episodes \[a total of ≤ 6 episodes or \> 6 episodes over the 2-day diary collection period\]) as factors. A hierarchical analysis strategy to adjust for multiplicity was not implemented."||0.729|-0.431|= 0.6076
72548621|NCT02097121|144626612|SUPERIORITY||Risk difference %|15.5|||=|0.6092|TWO_SIDED|95.0|-18.94|46.19|||Cochran-Mantel-Haenszel|||"Treatment Difference of 100 U versus 25 U~Pairwise comparisons of 100 U versus 25 U of BOTOX up to Week 12 in Treatment Cycle 1 was evaluated using the Cochran-Mantel-Haenszel (CMH) method stratified by baseline daytime urinary urgency incontinence episodes (a total of ≤ 6 episodes or \> 6 episodes over the 2-day diary collection period)."||46.19|-18.94|= 0.6092
72548622|NCT02097121|144626612|SUPERIORITY||Risk difference %|17.6|||=|0.4824|TWO_SIDED|95.0|-16.2|48.9|||Cochran-Mantel-Haenszel|||"Treatment Difference of 50 U versus 25 U~Pairwise comparisons of 50 U versus 25 U of BOTOX up to Week 12 in Treatment Cycle 1 was evaluated using the Cochran-Mantel-Haenszel (CMH) method stratified by baseline daytime urinary urgency incontinence episodes (a total of ≤ 6 episodes or \> 6 episodes over the 2-day diary collection period)."||48.9|-16.2|= 0.4824
72582251|NCT05085834|144695085|OTHER|Generalized estimating equations were used while adjusting for age and sex, and examining interactions between time and treatment. Combining linear coefficients in the equation while accounting for the multiplicative effects of treatment and time were considered to assess the true effect size of zinc supplementation on biomarkers.|β coefficient|0.41|STANDARD_ERROR_OF_MEAN|20.19||0.98|TWO_SIDED|95.0|-39.16|39.98|||linear combination of coefficients|||effect of Zinc supplementation on ln(ICAM, ng/mL)||39.98|-39.16|0.98
72548623|NCT00661999|144626623|SUPERIORITY_OR_OTHER|||||||0.39||95.0|||||Fisher Exact|||With 176 evaluable participants per treatment arm, there would have been \>=80% power to detect a difference across two treatment arms of 15% in the primary hematopoietic response endpoint through Fisher's exact test, if the true percentage of patients that experience a hematopoietic response was at least 30% in the superior group, with a 2.5% type I error rate.||||0.39
72582252|NCT05085834|144695086|OTHER|Generalized estimating equations were used while adjusting for age and sex, and examining interactions between time and treatment. Combining linear coefficients in the equation while accounting for the multiplicative effects of treatment and time were considered to assess the true effect size of zinc supplementation on biomarkers.|β coefficient|0.04|STANDARD_ERROR_OF_MEAN|0.06||0.55|TWO_SIDED|95.0|-0.09|0.16|||linear combination of coefficients|||effect of Zinc supplementation on ln(sTNF-RI , pg/mL)||0.16|-0.09|0.55
72412525|NCT03029208|144333152|SUPERIORITY||LS mean difference|-0.48||||0.6495|TWO_SIDED|95.0|-2.96|1.99|||MMRM||SF-36 HRQoL mental health domain score was analyzed using an MMRM approach with an unstructured covariance matrix to compare the difference in LS means between arms at Week 28.|||1.99|-2.96|0.6495
72412526|NCT03029208|144333152|SUPERIORITY||LS mean difference|-0.27||||0.5737|TWO_SIDED|95.0|-3.09|2.56|||MMRM||SF-36 HRQoL mental health domain score was analyzed using an MMRM approach with an unstructured covariance matrix to compare the difference in LS means between arms at Week 52.|||2.56|-3.09|0.5737
72548624|NCT00661999|144626623|SUPERIORITY_OR_OTHER|||||||0.73||95.0|||||Fisher Exact|||With 176 evaluable participants per treatment arm, there would have been \>=80% power to detect a difference across two treatment arms of 15% in the primary hematopoietic response endpoint through Fisher's exact test, if the true percentage of patients that experience a hematopoietic response was at least 30% in the superior group, with a 2.5% type I error rate.||||0.73
72548625|NCT00661999|144626625|SUPERIORITY_OR_OTHER|||||||0.725||95.0|||||Fisher Exact|||With 176 evaluable participants per treatment arm, there would have been \>=80% power to detect a difference across two treatment arms of 15% in the true percentage of patients that need transfusion was at least 30% in the superior group, with a 2.5% type I error rate.||||0.7250
72548626|NCT00661999|144626625|SUPERIORITY_OR_OTHER|||||||0.87||95.0|||||Fisher Exact|||With 176 evaluable participants per treatment arm, there would have been \>=80% power to detect a difference across two treatment arms of 15% in the true percentage of patients that need transfusion was at least 30% in the superior group, with a 2.5% type I error rate.||||0.8700
72548627|NCT00661999|144626626|SUPERIORITY_OR_OTHER|||||||0.6639||95.0|||||t-test, 2 sided|||With 176 evaluable participants per treatment arm, there would have been \>=80% power to detect a difference across two treatment arms of 33% of the standard deviation in average hemoglobin levels through two-sided alternative, with a 2.5% type I error rate.||||0.6639
72548628|NCT00661999|144626626|SUPERIORITY_OR_OTHER|||||||0.566||95.0|||||t-test, 2 sided|||With 176 evaluable participants per treatment arm, there would have been \>=80% power to detect a difference across two treatment arms of 33% of the standard deviation in average hemoglobin levels through two-sided alternative, with a 2.5% type I error rate.||||0.5660
72548629|NCT00661999|144626627|SUPERIORITY_OR_OTHER|||||||0.1124||95.0|||||t-test, 2 sided|||With 176 evaluable participants per treatment arm, there would have been \>=80% power to detect a difference across two treatment arms of 33% of the standard deviation in average hemoglobin levels through two-sided alternative, with a 2.5% type I error rate.||||0.1124
72548630|NCT00661999|144626627|SUPERIORITY_OR_OTHER|||||||0.2051||95.0|||||t-test, 2 sided|||With 176 evaluable participants per treatment arm, there would have been \>=80% power to detect a difference across two treatment arms of 33% of the standard deviation in average hemoglobin levels through two-sided alternative, with a 2.5% type I error rate.||||0.2051
72548631|NCT00661999|144626628|SUPERIORITY_OR_OTHER|||||||0.0648||95.0|||||Log Rank|||||||0.0648
72548632|NCT00661999|144626630|SUPERIORITY_OR_OTHER|||||||0.61||95.0|||||t-test, 2 sided|||With 176 evaluable participants per treatment arm, there would have been \>=80% power to detect a difference across two treatment arms of 33% of the standard deviation in participant QOL through t-test/Wilcoxon test, with a 2.5% type I error rate. A 10 points shift on a 0-100 point scale in QOL measures is generally considered clinically relevant and specifically important in the use of UNISCALE, BFI and FACT-An.||||0.61
72548633|NCT00661999|144626630|SUPERIORITY_OR_OTHER|||||||0.44||95.0|||||t-test, 2 sided|||With 176 evaluable participants per treatment arm, there would have been \>=80% power to detect a difference across two treatment arms of 33% of the standard deviation in participant QOL through t-test/Wilcoxon test, with a 2.5% type I error rate. A 10 points shift on a 0-100 point scale in QOL measures is generally considered clinically relevant and specifically important in the use of UNISCALE, BFI and FACT-An.||||0.44
72548634|NCT00661999|144626631|SUPERIORITY_OR_OTHER|||||||0.62||95.0|||||t-test, 2 sided|||With 176 evaluable participants per treatment arm, there would have been \>=80% power to detect a difference across two treatment arms of 33% of the standard deviation in participant QOL through t-test/Wilcoxon test, with a 2.5% type I error rate. A 10 points shift on a 0-100 point scale in QOL measures is generally considered clinically relevant and specifically important in the use of UNISCALE, BFI and FACT-An.||||0.62
72548635|NCT00661999|144626631|SUPERIORITY_OR_OTHER|||||||0.3||95.0|||||t-test, 2 sided|||With 176 evaluable participants per treatment arm, there would have been \>=80% power to detect a difference across two treatment arms of 33% of the standard deviation in participant QOL through t-test/Wilcoxon test, with a 2.5% type I error rate. A 10 points shift on a 0-100 point scale in QOL measures is generally considered clinically relevant and specifically important in the use of UNISCALE, BFI and FACT-An.||||0.30
72548636|NCT00661999|144626632|SUPERIORITY_OR_OTHER|||||||0.19||95.0|||||t-test, 2 sided|||With 176 evaluable participants per treatment arm, there would have been \>=80% power to detect a difference across two treatment arms of 33% of the standard deviation in participant QOL through t-test/Wilcoxon test, with a 2.5% type I error rate. A 10 points shift on a 0-100 point scale in QOL measures is generally considered clinically relevant and specifically important in the use of UNISCALE, BFI and FACT-An.||||0.19
72582253|NCT05085834|144695086|OTHER|Generalized estimating equations were used while adjusting for age and sex, and examining interactions between time and treatment. Combining linear coefficients in the equation while accounting for the multiplicative effects of treatment and time were considered to assess the true effect size of zinc supplementation on biomarkers.|β coefficient|-0.004|STANDARD_ERROR_OF_MEAN|0.07||0.95|TWO_SIDED|95.0|-0.13|0.13|||linear combination of coefficients|||effect of Zinc supplementation on ln(sTNF-RII, pg/m)||0.13|-0.13|0.95
72548637|NCT00661999|144626632|SUPERIORITY_OR_OTHER|||||||0.17||95.0|||||t-test, 2 sided|||With 176 evaluable participants per treatment arm, there would have been \>=80% power to detect a difference across two treatment arms of 33% of the standard deviation in participant QOL through t-test/Wilcoxon test, with a 2.5% type I error rate. A 10 points shift on a 0-100 point scale in QOL measures is generally considered clinically relevant and specifically important in the use of UNISCALE, BFI and FACT-An.||||0.17
72548638|NCT00661999|144626633|SUPERIORITY_OR_OTHER|||||||0.73||95.0|||||t-test, 2 sided|||With 176 evaluable participants per treatment arm, there would have been \>=80% power to detect a difference across two treatment arms of 33% of the standard deviation in participant QOL through t-test/Wilcoxon test, with a 2.5% type I error rate. A 10 points shift on a 0-100 point scale in QOL measures is generally considered clinically relevant and specifically important in the use of UNISCALE, BFI and FACT-An.||||0.73
72548639|NCT00661999|144626633|SUPERIORITY_OR_OTHER|||||||0.83||95.0|||||t-test, 2 sided|||With 176 evaluable participants per treatment arm, there would have been \>=80% power to detect a difference across two treatment arms of 33% of the standard deviation in participant QOL through t-test/Wilcoxon test, with a 2.5% type I error rate. A 10 points shift on a 0-100 point scale in QOL measures is generally considered clinically relevant and specifically important in the use of UNISCALE, BFI and FACT-An.||||0.83
72548640|NCT00661999|144626634|SUPERIORITY_OR_OTHER|||||||0.3852||95.0||||Test Comparison for Week 1 Level|Kruskal-Wallis|||||||0.3852
72548641|NCT00661999|144626634|SUPERIORITY_OR_OTHER|||||||0.0663||95.0||||Test Comparison for Week 7 Level.|Kruskal-Wallis|||||||0.0663
72548642|NCT00661999|144626634|SUPERIORITY_OR_OTHER|||||||0.322||95.0||||Test Comparison for Week 16 Level|Kruskal-Wallis|||||||0.3220
72548643|NCT00661999|144626635|SUPERIORITY_OR_OTHER|||||||0.1826||95.0||||Test Comparison for Week 1 Level.|Kruskal-Wallis|||||||0.1826
72548644|NCT00661999|144626635|SUPERIORITY_OR_OTHER|||||||0.0113||95.0||||Test comparison for week 7 level|Kruskal-Wallis|||||||0.0113
72548645|NCT00661999|144626635|SUPERIORITY_OR_OTHER|||||||0.3358||95.0||||Test Comparison for week 16 level|Kruskal-Wallis|||||||0.3358
72548646|NCT00661999|144626636|SUPERIORITY_OR_OTHER|||||||0.9022||95.0||||Test comparison for Baseline level.|Kruskal-Wallis|||||||0.9022
72548647|NCT00661999|144626636|SUPERIORITY_OR_OTHER|||||||0.0002||95.0||||Test Comparison for Week 7 Level.|Kruskal-Wallis|||||||0.0002
72548648|NCT00661999|144626636|SUPERIORITY_OR_OTHER|||||||0.0022||95.0||||Test Comparison for Week 16 Level.|Kruskal-Wallis|||||||0.0022
72548649|NCT00661999|144626637|SUPERIORITY_OR_OTHER|||||||0.1137||95.0||||Test comparison for baseline level.|Kruskal-Wallis|||||||0.1137
72548650|NCT00661999|144626637|SUPERIORITY_OR_OTHER|||||||0.8042||95.0||||Test comparison for week 7 level.|Kruskal-Wallis|||||||0.8042
72548651|NCT00661999|144626637|SUPERIORITY_OR_OTHER|||||||0.2016||95.0||||Test comparison for week 16 level.|Kruskal-Wallis|||||||0.2016
72548652|NCT00661999|144626638|SUPERIORITY_OR_OTHER|||||||0.1139||95.0||||Test comparison for baseline level.|Kruskal-Wallis|||||||0.1139
72548653|NCT00661999|144626638|SUPERIORITY_OR_OTHER|||||||0.0424||95.0||||Test comparison for week 7 level.|Kruskal-Wallis|||||||0.0424
72548654|NCT00661999|144626638|SUPERIORITY_OR_OTHER|||||||0.2025||95.0||||Test comparison for week 16 level.|Kruskal-Wallis|||||||0.2025
72548655|NCT03384745|144626655|SUPERIORITY|A sample size of 300 subjects has 99% power to detect a statistically significant difference between any treatment arm and placebo in the IGA score of 0 or 1 rate at Week 12, with a two-sided, unadjusted type I error of 0.05. Calculations assume IGA score 0 or 1 rates \>88% for study drug and \<=7% for placebo.|||||<|0.0001|||||||Cochran-Mantel-Haenszel|||Null hypotheses were tested at Week 12 (individual M1095 treatment arms would not be different from placebo with respect to achievement of IGA scores of 0 or 1). The primary analysis was based on the intent-to-treat (ITT) population using a non-responder imputation (NRI) for missing values. Primary treatment comparisons versus placebo were made with the two-sided Cochran-Mantel-Haenszel (CMH) test stratified by actual prior biologic use (yes/no) and body weight (\<=90; \>90kg).|At Week 12, none (0.0% \[95% CI 0.0-6.8\]) of the 52 participants in the placebo group had an IGA score of 0 or 1 versus 25 (48.1% \[34.0-62.4\], p\<0.0001) of 52 participants in the M1095 30mg treatment group. Odds ratio could not be calculated due to the placebo group containing no responders.|||<0.0001
72548656|NCT03384745|144626655|SUPERIORITY|A sample size of 300 subjects has 99% power to detect a statistically significant difference between any treatment arm and placebo in the IGA score of 0 or 1 rate at Week 12, with a two-sided, unadjusted type I error of 0.05. Calculations assume IGA score 0 or 1 rates \>88% for study drug and \<=7% for placebo.|||||<|0.0001|||||||Cochran-Mantel-Haenszel|||Null hypotheses were tested at Week 12 (individual M1095 treatment arms would not be different from placebo with respect to achievement of IGA scores of 0 or 1). The primary analysis was based on the intent-to-treat (ITT) population using a non-responder imputation (NRI) for missing values. Primary treatment comparisons versus placebo were made with the two-sided Cochran-Mantel-Haenszel (CMH) test stratified by actual prior biologic use (yes/no) and body weight (\<=90; \>90kg).|At Week 12, none (0.0% \[95% CI 0.0-6.8\]) of the 52 participants in the placebo group had an IGA score of 0 or 1 versus 44 (84.6% \[71.9-93.1\], p\<0.0001) of 52 participants in the M1095 60mg treatment group. Odds ratio could not be calculated due to the placebo group containing no responders.|||<0.0001
72552703|NCT00322465|144636214|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.39||||0.074|TWO_SIDED|95.0|0.92|6.22||A priori threshold for statistical signficance was p\<0.05.|Regression, Logistic|Odds ratio has been adjusted for other independent variables included in the model, which are found in the other Statistical Analysis sections.||The null hypothesis is that the odds ratio for ever having sex with a prostitute or for money, drugs, or other things(reference category is no) is 1 versus the alternative that it is greater than or less than 1. This was tested in a multivariable logistic regression model.||6.22|0.92|0.074
72552704|NCT00322465|144636215|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.8||||0.032|TWO_SIDED|95.0|0.66|0.98||A priori threshold for statistical significance was p\<0.05.|Regression, Logistic|No other independent variables were included in the model.||The null hypothesis is that the odds ratio for age (per 5 years) is 1 versus the alternative that the odds ratio is greater than or less than 1.||0.98|0.66|0.032
72552705|NCT01790581|144636221|SUPERIORITY_OR_OTHER|||||||0.904|TWO_SIDED||||||MANOVA|||This analysis examined the change in balance scores from baseline to 1-day post intervention for all three reach distances (Anterior, Posteriomedial, Posteriolateral) using a MANOVA.||||.904
72552706|NCT01790581|144636223|SUPERIORITY_OR_OTHER|||||||0.5|TWO_SIDED||||||MANOVA|||This analysis examined the change in disability scores from baseline to 1-day post intervention for both disability scores (FAAM, FAAM-S) using a MANOVA.||||.5
72552707|NCT00834535|144636261|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model containing factors for sequence of products, subjects within sequence, periods, and products was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|100.83||||||90.0|93.98|108.17|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||108.17|93.98|
72552708|NCT00834535|144636262|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model containing factors for sequence of products, subjects within sequence, periods, and products was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|96.1||||||90.0|92.14|100.22|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||100.22|92.14|
72548657|NCT03384745|144626655|SUPERIORITY|A sample size of 300 subjects has 99% power to detect a statistically significant difference between any treatment arm and placebo in the IGA score of 0 or 1 rate at Week 12, with a two-sided, unadjusted type I error of 0.05. Calculations assume IGA score 0 or 1 rates \>88% for study drug and \<=7% for placebo.|||||<|0.0001|||||||Cochran-Mantel-Haenszel|||Null hypotheses were tested at Week 12 (individual M1095 treatment arms would not be different from placebo with respect to achievement of IGA scores of 0 or 1). The primary analysis was based on the intent-to-treat (ITT) population using a non-responder imputation (NRI) for missing values. Primary treatment comparisons versus placebo were made with the two-sided Cochran-Mantel-Haenszel (CMH) test stratified by actual prior biologic use (yes/no) and body weight (\<=90; \>90kg).|At Week 12, none (0.0% \[95% CI 0.0-6.8\]) of the 52 participants in the placebo group had an IGA score of 0 or 1 versus 41 (77.4% \[63.8-87.7\], p\<0.0001) of 53 participants in the M1095 120mg normal load treatment group. Odds ratio could not be calculated due to the placebo group containing no responders.|||<0.0001
72552709|NCT00834535|144636263|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model containing factors for sequence of products, subjects within sequence, periods, and products was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|96.57||||||90.0|92.8|100.49|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||100.49|92.8|
72552710|NCT02055963|144636273|OTHER|||||||0.98|||||||Wilcoxon Rank Sum Test|||||||0.98
72552711|NCT01819597|144636283|OTHER|This is a phase II study design to determine the non-futility of proceeding to a phase III pivotal evaluation. The study group was planned to be compared to a propensity score matching (PSM) cohort from to the patients in the medical arms of the SAMMPRIS trial and to patients in the medical arm of COSS that had demonstrated angiographic intracranial atherosclerosis and occlusion.|Hazard Ratio (HR)|0.38||||0.08|TWO_SIDED|90.0|0.14|0.94||Pre-established α ≤ 0.10 for phase IIa|Regression, Cox|Alpha set at ≤ 0.1. for phase II study|ERSIAS/ Controls.|We derived the sample size required to power the trial to test the difference between two binomial event rates using the method of Farrington and Manning as implemented in R package gsDesign (Anderson, 2011). An estimated sample size of 52 patients will be necessary to detect a ∆ of 0.05, with a one-sided alpha of 0.10 and a beta of 0.10 - acceptable parameters for a non-definitive, non-futility study (Palesch et al., 2005, Levin, 2005).||0.94|0.14|0.08
72552712|NCT02495857|144636290|SUPERIORITY||Mean Difference (Net)|36.18|||||TWO_SIDED|95.0|10.25|62.11||||||||62.11|10.25|
72552713|NCT02495857|144636291|SUPERIORITY||Mean Difference (Net)|36.19|||||TWO_SIDED|95.0|10.25|62.11||||||||62.11|10.25|
72552714|NCT02495857|144636292|EQUIVALENCE|From baseline to week 26 visit, change in the WOMAC stiffness score was evaluated.|Mean Difference (Net)|5.63|||||TWO_SIDED|95.0|-13.61|8.49||||||||8.49|-13.61|
72552715|NCT00905346|144636300|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of the LS Mean (Test/Ref x 100)|98.39||||||90.0|94.36|102.59|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||102.59|94.36|
72552716|NCT00905346|144636301|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of the LS Mean (Test/Ref x 100)|102.92||||||90.0|99.88|106.05|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||106.05|99.88|
72552717|NCT00905346|144636302|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of the LS Mean (Test/Ref x 100)|102.63||||||90.0|99.24|106.14|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||106.14|99.24|
72552718|NCT04000815|144636337|OTHER||||||<|0.017||||||p-value is adjusted for multiple comparisons|Kruskal-Wallis|||||||<0.017
72552719|NCT04000815|144636338|OTHER||||||<|0.05|||||||Bi-variate correlation analysis|Bi-variate correlation analyses were performed in groups 1 and 2 between serum CNP and FSH and between serum CNP and LH using Spearman test.||||||<0.05
72552720|NCT04000815|144636339|OTHER||||||<|0.05|||||||Bi-variate correlation|Spearman test was applied.||||||<0.05
72552721|NCT04000815|144636340|OTHER||||||<|0.05|||||||Bi-variate correlation analyses|Bi-variate correlation analyses were performed for all subjects in groups 1 and 2 between serum CNP and E2 using Spearman test.||||||<0.05
72552722|NCT00840099|144636391|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|ANOVA|Test/Reference Ratio of Means x 100|100.91||||||90.0|95.82|106.26|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||106.26|95.82|
72552723|NCT00840099|144636392|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|ANOVA|Test/Reference Ratio of the mean x 100|102.79||||||90.0|100.69|104.94|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||104.94|100.69|
72552724|NCT00840099|144636393|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|ANOVA|Test/Reference Ratio of the mean x 100|102.75||||||90.0|100.62|104.93|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||104.93|100.62|
72552725|NCT00840099|144636394|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|ANOVA|Test/Reference Ratio of the Mean x 100|100.47||||||90.0|93.28|108.2|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||108.20|93.28|
72552726|NCT00840099|144636395|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|ANOVA|Ratio of the mean|104.15||||||90.0|96.35|112.58|||||Bioequivalence is established when 80% Confidence Interval falls within 80 - 125|||112.58|96.35|
72552727|NCT00840099|144636396|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|ANOVA|Test/Reference Ratio of the mean x 100|104.06||||||90.0|95.85|112.97|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||112.97|95.85|
72582254|NCT05085834|144695086|OTHER|Generalized estimating equations were used while adjusting for age and sex, and examining interactions between time and treatment. Combining linear coefficients in the equation while accounting for the multiplicative effects of treatment and time were considered to assess the true effect size of zinc supplementation on biomarkers.|β coefficient|0.07|STANDARD_ERROR_OF_MEAN|0.19||0.73|TWO_SIDED|95.0|-0.3|0.43|||linear combination of coefficients|||effect of Zinc supplementation on ln(IL-6, pg/mL)||0.43|-0.30|0.73
72412527|NCT03029208|144333152|SUPERIORITY||LS mean difference|0.33||||0.3963|TWO_SIDED|95.0|-2.15|2.82|||MMRM||SF-36 HRQoL role-emotional domain score was analyzed using an MMRM approach with an unstructured covariance matrix to compare the difference in LS means between arms at Week 8.|||2.82|-2.15|0.3963
72548658|NCT03384745|144626655|SUPERIORITY|A sample size of 300 subjects has 99% power to detect a statistically significant difference between any treatment arm and placebo in the IGA score of 0 or 1 rate at Week 12, with a two-sided, unadjusted type I error of 0.05. Calculations assume IGA score 0 or 1 rates \>88% for study drug and \<=7% for placebo.|||||<|0.0001|||||||Cochran-Mantel-Haenszel|||Null hypotheses were tested at Week 12 (individual M1095 treatment arms would not be different from placebo with respect to achievement of IGA scores of 0 or 1). The primary analysis was based on the intent-to-treat (ITT) population using a non-responder imputation (NRI) for missing values. Primary treatment comparisons versus placebo were made with the two-sided Cochran-Mantel-Haenszel (CMH) test stratified by actual prior biologic use (yes/no) and body weight (\<=90; \>90kg).|At Week 12, none (0.0% \[95% CI 0.0-6.8\]) of the 52 participants in the placebo group had an IGA score of 0 or 1 versus 45 (88.2% \[76.1-95.6\], p\<0.0001) of 51 participants in the M1095 120mg augmented load treatment group. Odds ratio could not be calculated due to the placebo group containing no responders.|||<0.0001
72548659|NCT03384745|144626655|SUPERIORITY|A sample size of 300 subjects has 99% power to detect a statistically significant difference between any treatment arm and placebo in the IGA score of 0 or 1 rate at Week 12, with a two-sided, unadjusted type I error of 0.05. Calculations assume IGA score 0 or 1 rates \>88% for study drug and \<=7% for placebo.|||||<|0.0001|||||||Cochran-Mantel-Haenszel|||Null hypotheses were tested at Week 12 (individual M1095 treatment arms would not be different from placebo with respect to achievement of IGA scores of 0 or 1). The primary analysis was based on the intent-to-treat (ITT) population using a non-responder imputation (NRI) for missing values. Primary treatment comparisons versus placebo were made with the two-sided Cochran-Mantel-Haenszel (CMH) test stratified by actual prior biologic use (yes/no) and body weight (\<=90; \>90kg).|At Week 12, none (0.0% \[95% CI 0.0-6.8\]) of the 52 participants in the placebo group had an IGA score of 0 or 1 versus 41 (77.4% \[63.8-87.7\], p\<0.0001) of 53 participants in the secukinumab 300mg treatment group. Odds ratio could not be calculated due to the placebo group containing no responders.|||<0.0001
72548660|NCT03008460|144626671|NON_INFERIORITY|Non-inferiority would be demonstrated if the lower limit of the 95% confidence interval of the adjusted treatment difference was higher than -15%.|Adjusted treatment difference|-7.61||||0.0907|TWO_SIDED|95.0|-18.45|3.24||P-value for non-inferiority was estimated from the adjusted treatment difference.|Regression, Logistic|||Analysis of the treatment difference (Eziclen®/Izinova® minus Klean-Prep®) was performed using a logistic regression model, including treatment and country as covariates.||3.24|-18.45|0.0907
72548661|NCT03008460|144626672|OTHER||Adjusted treatment difference|-0.18||||0.0428|TWO_SIDED|95.0|-0.36|-0.01|||ANOVA|||Analysis of the treatment difference (Eziclen®/Izinova® minus Klean-Prep®) was performed using a 2-way ANOVA, including treatment and country as covariates.||-0.01|-0.36|0.0428
72548662|NCT03008460|144626673|OTHER||Adjusted treatment difference|-0.07||||0.4676|TWO_SIDED|95.0|-0.25|0.12|||ANOVA|||"Left colon:~Analysis of the treatment difference (Eziclen®/Izinova® minus Klean-Prep®) was performed using a 2-way ANOVA, including treatment and country as covariates."||0.12|-0.25|0.4676
72548663|NCT03008460|144626673|OTHER||Adjusted treatment difference|-0.09||||0.3076|TWO_SIDED|95.0|-0.25|0.08|||ANOVA|||"Transverse colon:~Analysis of the treatment difference (Eziclen®/Izinova® minus Klean-Prep®) was performed using a 2-way ANOVA, including treatment and country as covariates."||0.08|-0.25|0.3076
72548664|NCT03008460|144626673|OTHER||Adjusted treatment difference|-0.24||||0.0155|TWO_SIDED|95.0|-0.44|-0.05|||ANOVA|||"Right colon:~Analysis of the treatment difference (Eziclen®/Izinova® minus Klean-Prep®) was performed using a 2-way ANOVA, including treatment and country as covariates."||-0.05|-0.44|0.0155
72548665|NCT03008460|144626673|OTHER||Adjusted treatment difference|-0.36||||0.0975|TWO_SIDED|95.0|-0.79|0.07|||ANOVA|||"Global score:~Analysis of the treatment difference (Eziclen®/Izinova® minus Klean-Prep®) was performed using a 2-way ANOVA, including treatment and country as covariates."||0.07|-0.79|0.0975
72548666|NCT03008460|144626674|OTHER||Adjusted treatment difference rate|1.3847||||0.2428|TWO_SIDED|95.0|0.8|2.4|||CMH chi-square|||Analysis was performed using Cochran-Mantel-Haenszel (CMH) chi-square method (using the general association statistic), stratified on country.||2.4|0.8|0.2428
72548667|NCT03008460|144626675|OTHER||Adjusted treatment difference rate|24.0219|||<|0.0001|TWO_SIDED|95.0|12.6|45.9|||CMH chi-square|||Analysis was performed using CMH chi-square method (using the general association statistic), stratified on country.||45.9|12.6|<0.0001
72582255|NCT05085834|144695086|OTHER|Generalized estimating equations were used while adjusting for age and sex, and examining interactions between time and treatment. Combining linear coefficients in the equation while accounting for the multiplicative effects of treatment and time were considered to assess the true effect size of zinc supplementation on biomarkers.|β coefficient|0.12|STANDARD_ERROR_OF_MEAN|0.18||0.48|TWO_SIDED|95.0|-0.22|0.47|||linear combination of coefficients|||effect of Zinc supplementation on ln(IP-10, pg/mL)||0.47|-0.22|0.48
72548668|NCT03008460|144626676|OTHER||Adjusted treatment difference rate|1.0022||||0.9257|TWO_SIDED|95.0|1.0|1.1|||CMH chi-square|||Analysis was performed using CMH chi-square method (using the general association statistic), stratified on country.||1.1|1.0|0.9257
72548669|NCT03008460|144626678|OTHER||Adjusted treatment difference|-0.93||||0.4459|TWO_SIDED|95.0|-3.32|1.47|||ANOVA|||Analysis of the treatment difference (Eziclen®/Izinova® minus Klean-Prep®) was performed using a 2-way ANOVA, including treatment and country as covariates.||1.47|-3.32|0.4459
72548670|NCT03008460|144626679|OTHER||Adjusted treatment difference|0.71|||<|0.0001|TWO_SIDED|95.0|0.4|1.03|||ANOVA|||Analysis of the treatment difference (Eziclen®/Izinova® minus Klean-Prep®) was performed using a 2-way ANOVA, including treatment and country as covariates.||1.03|0.40|<0.0001
72582256|NCT05085834|144695087|OTHER|Generalized estimating equations were used while adjusting for age and sex, and examining interactions between time and treatment. Combining linear coefficients in the equation while accounting for the multiplicative effects of treatment and time were considered to assess the true effect size of zinc supplementation on biomarkers.|β coefficient|1819.18|STANDARD_ERROR_OF_MEAN|8530.03||0.83|TWO_SIDED|95.0|-14899.37|18537.74|||linear combination of coefficients|||effect of Zinc supplementation on ln(OxLDL, U/L)||18537.74|-14899.37|0.83
72548671|NCT03008460|144626680|OTHER||Adjusted treatment difference rate|1.22||||0.3945|TWO_SIDED|95.0|-1.6|4.05|||ANOVA|||"Dose 1:~Analysis of the treatment difference (Eziclen®/Izinova® minus Klean-Prep®) was performed using a 2-way ANOVA, including treatment and country as covariates."||4.05|-1.60|0.3945
72582257|NCT05085834|144695088|OTHER|Generalized estimating equations were used while adjusting for age and sex, and examining interactions between time and treatment. Combining linear coefficients in the equation while accounting for the multiplicative effects of treatment and time were considered to assess the true effect size of zinc supplementation on biomarkers.|β coefficient|0.01|STANDARD_ERROR_OF_MEAN|0.07||0.84|TWO_SIDED|95.0|-0.12|0.15|||linear combination of coefficients|||effect of Zinc supplementation on ln(Non-HDL Cholesterol (mg/dL))||0.15|-0.12|0.84
72548672|NCT03008460|144626680|OTHER||Adjusted treatment difference rate|6.38||||0.0085|TWO_SIDED|95.0|1.65|11.12|||ANOVA|||"Dose 2:~Analysis of the treatment difference (Eziclen®/Izinova® minus Klean-Prep®) was performed using a 2-way ANOVA, including treatment and country as covariates."||11.12|1.65|0.0085
72582258|NCT05085834|144695088|OTHER|Generalized estimating equations were used while adjusting for age and sex, and examining interactions between time and treatment. Combining linear coefficients in the equation while accounting for the multiplicative effects of treatment and time were considered to assess the true effect size of zinc supplementation on biomarkers.|β coefficient|-0.08|STANDARD_ERROR_OF_MEAN|0.06||0.18|TWO_SIDED|95.0|-0.19|0.04|||linear combination of coefficients|||effect of Zinc supplementation on ln(HDL (mg/dL))||0.04|-0.19|0.18
72582259|NCT05085834|144695088|OTHER|Generalized estimating equations were used while adjusting for age and sex, and examining interactions between time and treatment. Combining linear coefficients in the equation while accounting for the multiplicative effects of treatment and time were considered to assess the true effect size of zinc supplementation on biomarkers.|β coefficient|-0.02|STANDARD_ERROR_OF_MEAN|0.09||0.84|TWO_SIDED|95.0|-0.19|0.15|||linear combination of coefficients|||effect of Zinc supplementation on ln(LDL (mg/dL))||0.15|-0.19|0.84
72582260|NCT05085834|144695088|OTHER|Generalized estimating equations were used while adjusting for age and sex, and examining interactions between time and treatment. Combining linear coefficients in the equation while accounting for the multiplicative effects of treatment and time were considered to assess the true effect size of zinc supplementation on biomarkers.|β coefficient|0.07|STANDARD_ERROR_OF_MEAN|0.11||0.55|TWO_SIDED|95.0|-0.15|0.29|||linear combination of coefficients|||effect of Zinc supplementation on ln(VLDL (mg/dL))||0.29|-0.15|0.55
72548673|NCT03008460|144626680|OTHER||Adjusted treatment difference rate|7.48||||0.0036|TWO_SIDED|95.0|2.46|12.5|||ANOVA|||"Global:~Analysis of the treatment difference (Eziclen®/Izinova® minus Klean-Prep®) was performed using a 2-way ANOVA, including treatment and country as covariates."||12.50|2.46|0.0036
72548674|NCT03008460|144626683|OTHER||Adjusted treatment difference|1.05||||0.0015|TWO_SIDED|95.0|0.41|1.69|||ANOVA|||Analysis of the treatment difference (Eziclen®/Izinova® minus Klean-Prep®) was performed using 2-way ANOVA, including treatment and country as covariates.||1.69|0.41|0.0015
72548675|NCT04947579|144626690|SUPERIORITY||Stratified difference|2.4||||0.829|TWO_SIDED|95.0|-18.2|22.7|||Cochran-Mantel-Haenszel||CC99677 60 mg - Placebo|||22.7|-18.2|0.829
72412528|NCT03029208|144333152|SUPERIORITY||LS mean difference|0.62||||0.322|TWO_SIDED|95.0|-2.01|3.25|||MMRM||SF-36 HRQoL role-emotional domain score was analyzed using an MMRM approach with an unstructured covariance matrix to compare the difference in LS means between arms at Week 12.|||3.25|-2.01|0.3220
72412529|NCT03029208|144333152|SUPERIORITY||LS mean difference|0.53||||0.3485|TWO_SIDED|95.0|-2.13|3.18|||MMRM||SF-36 HRQoL role-emotional domain score was analyzed using an MMRM approach with an unstructured covariance matrix to compare the difference in LS means between arms at Week 28.|||3.18|-2.13|0.3485
72412530|NCT03029208|144333152|SUPERIORITY||LS mean difference|-1.49||||0.8064|TWO_SIDED|95.0|-4.87|1.9|||MMRM||SF-36 HRQoL role-emotional domain score was analyzed using an MMRM approach with an unstructured covariance matrix to compare the difference in LS means between arms at Week 52.|||1.90|-4.87|0.8064
72412531|NCT03029208|144333152|SUPERIORITY||LS mean difference|-1.29||||0.8687|TWO_SIDED|95.0|-3.57|0.98|||MMRM||SF-36 HRQoL role-physical domain score was analyzed using an MMRM approach with an unstructured covariance matrix to compare the difference in LS means between arms at Week 8.|||0.98|-3.57|0.8687
72412532|NCT03029208|144333152|SUPERIORITY||LS mean difference|0.71||||0.2435|TWO_SIDED|95.0|-1.29|2.7|||MMRM||SF-36 HRQoL role-physical domain score was analyzed using an MMRM approach with an unstructured covariance matrix to compare the difference in LS means between arms at Week 12.|||2.70|-1.29|0.2435
72412533|NCT03029208|144333152|SUPERIORITY||LS mean difference|-0.87||||0.7747|TWO_SIDED|95.0|-3.15|1.41|||MMRM||SF-36 HRQoL role-physical domain score was analyzed using an MMRM approach with an unstructured covariance matrix to compare the difference in LS means between arms at Week 28.|||1.41|-3.15|0.7747
72412534|NCT03029208|144333152|SUPERIORITY||LS mean difference|-0.73||||0.7141|TWO_SIDED|95.0|-3.26|1.81|||MMRM||SF-36 HRQoL role-physical domain score was analyzed using an MMRM approach with an unstructured covariance matrix to compare the difference in LS means between arms at Week 52.|||1.81|-3.26|0.7141
72412535|NCT03029208|144333152|SUPERIORITY||LS mean difference|-1.03||||0.7803|TWO_SIDED|95.0|-3.65|1.59|||MMRM||SF-36 HRQoL social functioning domain score was analyzed using an MMRM approach with an unstructured covariance matrix to compare the difference in LS means between arms at Week 8.|||1.59|-3.65|0.7803
72412536|NCT03029208|144333152|SUPERIORITY||LS mean difference|-1.18||||0.8556|TWO_SIDED|95.0|-3.35|1.0|||MMRM||SF-36 HRQoL social functioning domain score was analyzed using an MMRM approach with an unstructured covariance matrix to compare the difference in LS means between arms at Week 12.|||1.00|-3.35|0.8556
72412537|NCT03029208|144333152|SUPERIORITY||LS mean difference|0.08||||0.4763|TWO_SIDED|95.0|-2.61|2.77|||MMRM||SF-36 HRQoL social functioning domain score was analyzed using an MMRM approach with an unstructured covariance matrix to compare the difference in LS means between arms at Week 28.|||2.77|-2.61|0.4763
72412538|NCT03029208|144333152|SUPERIORITY||LS mean difference|0.73||||0.3208|TWO_SIDED|95.0|-2.35|3.8|||MMRM||SF-36 HRQoL social functioning domain score was analyzed using an MMRM approach with an unstructured covariance matrix to compare the difference in LS means between arms at Week 52.|||3.80|-2.35|0.3208
72548676|NCT04947579|144626690|SUPERIORITY||Stratified difference|7.3||||0.512|TWO_SIDED|95.0|-13.8|27.5|||Cochran-Mantel-Haenszel||CC99677 150 mg - Placebo|||27.5|-13.8|0.512
72548677|NCT04947579|144626691|SUPERIORITY||Stratified difference|3.3||||0.725|TWO_SIDED|95.0|-14.9|21.0|||Cochran-Mantel-Haenszel||CC99677 60 mg - Placebo|||21.0|-14.9|0.725
72548678|NCT04947579|144626691|SUPERIORITY||Stratfied difference|12.2||||0.219|TWO_SIDED|95.0|-7.2|30.5|||Cochran-Mantel-Haenszel||CC99677 150 mg - Placebo|||30.5|-7.2|0.219
72412539|NCT03029208|144333153|SUPERIORITY||LS mean difference|-1.02||||0.791|TWO_SIDED|95.0|-3.5|1.46|||MMRM||SF-36 HRQoL vitality domain score was analyzed using an MMRM approach with an unstructured covariance matrix to compare the difference in LS means between arms at Week 28.|||1.46|-3.50|0.7910
72412540|NCT03029208|144333153|SUPERIORITY||LS mean difference|-1.45||||0.8648|TWO_SIDED|95.0|-4.03|1.14|||MMRM||SF-36 HRQoL vitality domain score was analyzed using an MMRM approach with an unstructured covariance matrix to compare the difference in LS means between arms at Week 52.|||1.14|-4.03|0.8648
72412541|NCT03029208|144333154|SUPERIORITY||LS mean difference|-0.28||||0.5879|TWO_SIDED|95.0|-2.75|2.19|||MMRM||SF-36 HRQoL physical functioning domain score was analyzed using an MMRM approach with an unstructured covariance matrix to compare the difference in LS means between arms at Week 28.|||2.19|-2.75|0.5879
72412542|NCT03029208|144333154|SUPERIORITY||LS mean difference|-1.43||||0.8525|TWO_SIDED|95.0|-4.12|1.26|||MMRM||SF-36 HRQoL physical functioning domain scor was analyzed using an MMRM approach with an unstructured covariance matrix to compare the difference in LS means between arms at Week 52.|||1.26|-4.12|0.8525
72412543|NCT03029208|144333155|SUPERIORITY||LS mean difference|0.03||||0.3154|TWO_SIDED|95.0|-0.09|0.14|||MMRM||MMRM model was fitted from Baseline up to Week 52 with factors for treatment, time, dialysis type, dialysis start manner, Baseline value and Baseline value by time and treatment by time interactions.|||0.14|-0.09|0.3154
72548679|NCT04947579|144626692|SUPERIORITY||Difference in Adjusted Means|-0.17|STANDARD_ERROR_OF_MEAN|0.167||0.299|TWO_SIDED|95.0|-0.5|0.16|||Longitudinal data analysis model||CC99677 60 mg - Placebo|||0.16|-0.50|0.299
72548680|NCT04947579|144626692|SUPERIORITY||Difference in Adjusted Means|-0.12|STANDARD_ERROR_OF_MEAN|0.168||0.488|TWO_SIDED|95.0|-0.45|0.22|||Longitudinal data analysis model||CC99677 150 mg - Placebo|||0.22|-0.45|0.488
72548681|NCT04947579|144626693|SUPERIORITY||Difference in Adjusted Means|0.01|STANDARD_ERROR_OF_MEAN|0.391||0.97|TWO_SIDED|95.0|-0.76|0.79|||Longitudinal data analysis model||CC99677 60 mg - Placebo|||0.79|-0.76|0.970
72548682|NCT04947579|144626693|SUPERIORITY||Difference in Adjusted Means|-0.17|STANDARD_ERROR_OF_MEAN|0.393||0.668|TWO_SIDED|95.0|-0.95|0.61|||Longitudinal data analysis model||CC99677 150 mg - Placebo|||0.61|-0.95|0.668
72548683|NCT04947579|144626694|SUPERIORITY||Difference in Adjusted Means|0.06|STANDARD_ERROR_OF_MEAN|0.416||0.89|TWO_SIDED|95.0|-0.77|0.88|||Longitudinal data analysis model||CC99677 60 mg - Placebo|||0.88|-0.77|0.890
72548684|NCT04947579|144626694|SUPERIORITY||Difference in Adjusted Means|0.25|STANDARD_ERROR_OF_MEAN|0.417||0.545|TWO_SIDED|95.0|-0.57|1.08|||Longitudinal data analysis model||CC99677 150 mg - Placebo|||1.08|-0.57|0.545
72548685|NCT04947579|144626695|SUPERIORITY||Difference in Adjusted Means|-0.28|STANDARD_ERROR_OF_MEAN|0.999||0.778|TWO_SIDED|95.0|-2.26|1.7|||Longitudinal data analysis model||CC99677 60 mg - Placebo|||1.70|-2.26|0.778
72548686|NCT04947579|144626695|SUPERIORITY||Difference in Adjusted Means|-1.0|STANDARD_ERROR_OF_MEAN|1.022||0.33|TWO_SIDED|95.0|-3.02|1.03|||Longitudinal data analysis model||CC99677 150 mg - Placebo|||1.03|-3.02|0.330
72548687|NCT04947579|144626696|SUPERIORITY||Difference in Adjusted Means|-0.82|STANDARD_ERROR_OF_MEAN|1.567||0.6|TWO_SIDED|95.0|-3.93|2.28|||Longitudinal data analysis model||CC99677 60 mg - Placebo|||2.28|-3.93|0.600
72548688|NCT04947579|144626696|SUPERIORITY||Difference in Adjusted Means|-1.31|STANDARD_ERROR_OF_MEAN|1.605||0.416|TWO_SIDED|95.0|-4.49|1.87|||Longitudinal data analysis model||CC99677 150 mg - Placebo|||1.87|-4.49|0.416
72548689|NCT04947579|144626697|SUPERIORITY||Adjusted Mean|-6.26|STANDARD_ERROR_OF_MEAN|10.741||||95.0|-27.31|14.79||||||||14.79|-27.31|
72548690|NCT04947579|144626697|SUPERIORITY||Adjusted Mean|-18.58|STANDARD_ERROR_OF_MEAN|9.181|||TWO_SIDED|95.0|-36.57|-0.58||||||||-0.58|-36.57|
72548691|NCT04947579|144626697|SUPERIORITY||Adjusted Mean|-12.16|STANDARD_ERROR_OF_MEAN|10.105|||TWO_SIDED|95.0|-31.96|7.65||||||||7.65|-31.96|
72548692|NCT01566409|144626703|NON_INFERIORITY_OR_EQUIVALENCE|The required sample size was based on a projected treatment success in the PEG group of 60%. With a power in excess of 80% and a critical level of significance of 0.05, 45 children were needed in each group to detect a 50% reduction in treatment effect in the placebo group, corresponding to 30% recovers without active maintenance treatment. Because of an expected drop-out rate of 25%, we aimed at including 115 children.||||||0.024|||||||Regression, Logistic|||||||0.024
72548693|NCT02683187|144626728|EQUIVALENCE|Insulin secretion, determined by insulin or C-peptide values in the 10 minutes after arginine infusion will be compared as a repeated measure for each subject in a 2 x 2 analysis of sitagliptin/placebo and Exendin-9/saline.|Median Difference (Final Values)|371.0|||<|0.05|TWO_SIDED||||||Mixed Models Analysis|||||||< 0.05
72548694|NCT00770315|144626729|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.76||||0.2192|TWO_SIDED|95.0|-1.98|0.45|||ANOVA||ANOVA model with baseline asthmatic condition, pollen region and treatment group as fixed effects|||0.45|-1.98|0.2192
72548695|NCT00770315|144626729|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.58||||0.0113|TWO_SIDED|95.0|-2.8|-0.36|||ANOVA||ANOVA model with baseline asthmatic condition, pollen region and treatment group as fixed effects|||-0.36|-2.80|0.0113
72548696|NCT00770315|144626729|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.04||||0.0015|TWO_SIDED|95.0|-3.3|-0.79|||ANOVA||ANOVA model with baseline asthmatic condition, pollen region and treatment group as fixed effects|||-0.79|-3.30|0.0015
72548697|NCT00770315|144626730|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.88||||0.0878|TWO_SIDED|95.0|-1.88|0.13|||ANOVA||ANOVA model with baseline asthmatic condition, pollen region and treatment group as fixed effects|||0.13|-1.88|0.0878
72548698|NCT00770315|144626730|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.28||||0.0125|TWO_SIDED|95.0|-2.29|-0.28|||ANOVA||ANOVA model with baseline asthmatic condition, pollen region and treatment group as fixed effects|||-0.28|-2.29|0.0125
72548699|NCT00770315|144626730|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.92||||0.0003|TWO_SIDED|95.0|-2.95|-0.88|||ANOVA||ANOVA model with baseline asthmatic condition, pollen region and treatment group as fixed effects|||-0.88|-2.95|0.0003
72548700|NCT00770315|144626731|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.26||||0.4781|TWO_SIDED|95.0|-0.96|0.45|||ANOVA||ANOVA model with baseline asthmatic condition, pollen region and treatment group as fixed effects|||0.45|-0.96|0.4781
72548701|NCT00770315|144626731|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5||||0.1695|TWO_SIDED|95.0|-1.21|0.21|||ANOVA||ANOVA model with baseline asthmatic condition, pollen region and treatment group as fixed effects|||0.21|-1.21|0.1695
72548702|NCT00770315|144626731|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.94||||0.0118|TWO_SIDED|95.0|-1.67|-0.21|||ANOVA||ANOVA model with baseline asthmatic condition, pollen region and treatment group as fixed effects|||-0.21|-1.67|0.0118
72548703|NCT00770315|144626732|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.34||||0.2622|TWO_SIDED|95.0|-0.93|0.25|||ANOVA||ANOVA model with baseline asthmatic condition, pollen region and treatment group as fixed effects|||0.25|-0.93|0.2622
72548704|NCT00770315|144626732|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4||||0.1914|TWO_SIDED|95.0|-0.99|0.2|||ANOVA||ANOVA model with baseline asthmatic condition, pollen region and treatment group as fixed effects|||0.20|-0.99|0.1914
72548705|NCT00770315|144626732|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.96||||0.0021|TWO_SIDED|95.0|-1.57|-0.35|||ANOVA||ANOVA model with baseline asthmatic condition, pollen region and treatment group as fixed effects|||-0.35|-1.57|0.0021
72548706|NCT00770315|144626733|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.51||||0.19|TWO_SIDED|95.0|-1.26|0.25|||ANOVA||ANOVA model with baseline asthmatic condition, pollen region and treatment group as fixed effects|||0.25|-1.26|0.1900
72548707|NCT00770315|144626733|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.08||||0.0053|TWO_SIDED|95.0|-1.84|-0.32|||ANOVA||ANOVA model with baseline asthmatic condition, pollen region and treatment group as fixed effects|||-0.32|-1.84|0.0053
72548708|NCT00770315|144626733|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.1||||0.0058|TWO_SIDED|95.0|-1.89|-0.32|||ANOVA||ANOVA model with baseline asthmatic condition, pollen region and treatment group as fixed effects|||-0.32|-1.89|0.0058
72548709|NCT02585258|144626734|SUPERIORITY||mean difference over 2-years|-0.37|||<|0.0001|ONE_SIDED|95.0||-0.23||one-sided.|Mixed Models Analysis||placebo is reference. Negative difference is beneficial, means lower disease activity in prednisolone group.|mixed model reports the effect of treatment, adjusted for stratification factors||-0.23||<0.0001
72548710|NCT02585258|144626735|SUPERIORITY||Risk Ratio (RR)|1.24||||0.02|ONE_SIDED|95.0|1.04|||one-sided|GEE||prednisolone/placebo|mixed model reports the effect of treatment, adjusted for stratification factors|||1.04|0.02
72412544|NCT03029208|144333156|SUPERIORITY||LS mean difference|-3.4||||0.7651|TWO_SIDED|95.0|-12.7|5.9|||MMRM||MMRM model was fitted from Baseline up to Week 52 with factors for treatment, time, dialysis type, dialysis start manner, Baseline value and Baseline value by time and treatment by time interactions.|||5.9|-12.7|0.7651
72548711|NCT02585258|144626736|SUPERIORITY||mean differences over 2 years|-1.67||||0.003|ONE_SIDED|95.0||-0.68||one-sided|Regression, Linear||placebo is reference. Negative difference means less damage progression in prednisolone group.|mixed model reports the effect of treatment, adjusted for stratification factors||-0.68||0.003
72548712|NCT01919190|144626737|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.8|TWO_SIDED||||||ANCOVA|||||||>0.8
72548713|NCT01919190|144626738|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0456|TWO_SIDED||||||Mixed Models Analysis|||||||0.0456
72548714|NCT02207231|144626747|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Cochran-Mantel-Haenszel chi-square test|||||||<0.001
72548715|NCT02207231|144626748|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Cochran-Mantel-Haenszel chi-square test|||||||<0.001
72548716|NCT02207231|144626749|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Cochran-Mantel-Haenszel chi-square test|||Week 24||||< 0.001
72548717|NCT02207231|144626749|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Cochran-Mantel-Haenszel chi-square test|||Week 48||||< 0.001
72548718|NCT02207231|144626750|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Cochran-Mantel-Haenszel chi-square test|||Week 24||||< 0.001
72548719|NCT02207231|144626750|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Cochran-Mantel-Haenszel chi-square test|||Week 48||||< 0.001
72548720|NCT02207231|144626751|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Cochran-Mantel-Haenszel chi-square test|||Week 24||||< 0.001
72548721|NCT02207231|144626751|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Cochran-Mantel-Haenszel chi-square test|||Week 48||||< 0.001
72548722|NCT02207231|144626752|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||ANOVA|||p value is based on analysis of variance (ANOVA) model stratified by investigator site (pooled).||||< 0.001
72548723|NCT02207231|144626753|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|non-inferiority margin= 10.0%|Difference in Percentage|19.3|||<|0.001|TWO_SIDED|95.0|12.9|25.7|||MH Z-test|||p value is based on 1-sided Mantel Haenszel (MH) Z-test adjusted for investigator site (pooled).||25.7|12.9|< 0.001
72548724|NCT02207231|144626753|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Cochran-Mantel-Haenszel chi-square test|||p value is based on the Cochran-Mantel-Haenszel chi-square test stratified by investigator site (pooled).||||< 0.001
72548725|NCT02207231|144626754|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|non-inferiority margin= 10.0%|Difference in Percentage|24.1|||<|0.001|TWO_SIDED|95.0|17.0|31.0|||MH Z-test|||p value is based on 1-sided MH Z-test adjusted for investigator site (pooled).||31.0|17.0|< 0.001
72548726|NCT02207231|144626754|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Cochran-Mantel-Haenszel chi-square test|||p value is based on the Cochran-Mantel-Haenszel chi-square test stratified by investigator site (pooled).||||< 0.001
72548727|NCT02207231|144626755|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|non-inferiority margin= 10%|Difference in percentage|18.0|||<|0.001|TWO_SIDED|95.0|12.4|23.8|||MH Z-test|||p value is based on 1-sided MH Z-test adjusted for investigator site (pooled).||23.8|12.4|< 0.001
72548728|NCT02207231|144626755|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Cochran-Mantel-Haenszel chi-square test|||p value is based on the Cochran-Mantel-Haenszel chi-square test stratified by investigator site (pooled).||||< 0.001
72548729|NCT02207231|144626756|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Cochran-Mantel-Haenszel chi-square test|||p value is based on the Cochran-Mantel-Haenszel chi-square test stratified by investigator site (pooled).||||< 0.001
72548730|NCT02207231|144626757|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||ANOVA|||p value is based on ANOVA model stratified by investigator site (pooled).||||< 0.001
72548731|NCT02207231|144626758|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Cochran-Mantel-Haenszel chi-square test|||p value is based on the Cochran-Mantel-Haenszel chi-square test stratified by investigator site (pooled).||||< 0.001
72552728|NCT01032083|144636397|EQUIVALENCE|For the primary outcome, linear regression was used to determine mean difference between treatment groups. Differences between groups are presented as mean differences with associated 95% confidence interval (CI). Baseline values for variables were included as covariates in regression models and adjusted according to analysis of covariance. All analyses were conducted under the intention-to-treat principle.|Mean Difference (Final Values)|-1.54||||0.36|TWO_SIDED|95.0|-4.91|1.8|||Regression, Linear|||||1.80|-4.91|0.36
72548732|NCT00655642|144626771|NON_INFERIORITY_OR_EQUIVALENCE|Based on the aforementioned values, we calculated a sample size for each treatment arm of 131 patients. We increased this sample estimate to 150 per treatment arm (total of 600 patients) to account for anticipated study attrition. Based on an unplanned interim conditional power futility analysis done at 30% information fraction, the decision was made to end the trial early.The futility analysis found the observed differences were far less than what was deemed clinically important.|Median Difference (Final Values)|12.0|STANDARD_DEVIATION|25.0||0.16||||||Being aware of the multiple comparison issues, we deliberately chose the 0.01 alpha level following a Bonferroni type of correction so that the overall type I error rate is about 0.05.|Kruskal-Wallis|We computed the effect of the 3 treatments relative to ondansetron.|Change in VAS score was calculated as (VAS 30 min - VAS baseline). We calculated the differences in median VAS reductions for each arm relative to ondansetron.|The null hypothesis is that ondanestron is not more effective in reducing nausea than metoclopramide, promethazine or isotonic normal saline. The sample size was chosen to detect a 12-mm difference in VAS improvement between ondanestron and any other treatment arm (assuming a SD of 25mm) at 90% power and 0.01 alpha significance level. We chose the 0.01 alpha level following a Bonferroni type of correction so that the overall type I error rate is about 0.05.||||0.16
72548733|NCT02016300|144626772|OTHER|||||||0.162|||||||Regression, Linear|||Difference between baseline and month 6.||||0.162
72548734|NCT02016300|144626772|OTHER|||||||0.094|||||||Regression, Linear|||Difference between baseline and month 12.||||0.094
72548735|NCT02016300|144626772|OTHER|||||||0.043|||||||Regression, Linear|||Difference between baseline and month 24.||||0.043
72548736|NCT02016300|144626773|OTHER|||||||0.387|||||||Regression, Linear|||Difference between baseline and month 6.||||0.387
72548737|NCT02016300|144626773|OTHER|||||||0.34|||||||Regression, Linear|||Difference between baseline and month 12.||||0.340
72548738|NCT02016300|144626773|OTHER|||||||0.179|||||||Regression, Linear|||Difference between baseline and month 24.||||0.179
72548739|NCT02016300|144626774|OTHER|||||||0.729|||||||Regression, Linear|||Difference between baseline and month 6.||||0.729
72548740|NCT02016300|144626774|OTHER|||||||0.958|||||||Regression, Linear|||Difference between baseline and month 12.||||0.958
72548741|NCT02016300|144626774|OTHER|||||||0.634|||||||Regression, Linear|||Difference between baseline and month 24.||||0.634
72548742|NCT02016300|144626775|OTHER|||||||0.733|||||||Regression, Linear|||Difference between baseline and month 6.||||0.733
72548743|NCT02016300|144626775|OTHER|||||||0.666|||||||Regression, Linear|||Difference between baseline and month 12.||||0.666
72582261|NCT05085834|144695088|OTHER|Generalized estimating equations were used while adjusting for age and sex, and examining interactions between time and treatment. Combining linear coefficients in the equation while accounting for the multiplicative effects of treatment and time were considered to assess the true effect size of zinc supplementation on biomarkers.|β coefficient|-0.01|STANDARD_ERROR_OF_MEAN|0.05||0.78|TWO_SIDED|95.0|-0.11|0.09|||linear combination of coefficients|||effect of Zinc supplementation on ln(Cholesterol (mg/dl))||0.09|-0.11|0.78
72582262|NCT05085834|144695088|OTHER|Generalized estimating equations were used while adjusting for age and sex, and examining interactions between time and treatment. Combining linear coefficients in the equation while accounting for the multiplicative effects of treatment and time were considered to assess the true effect size of zinc supplementation on biomarkers.|β coefficient|0.07|STANDARD_ERROR_OF_MEAN|0.12||0.58|TWO_SIDED|95.0|-0.17|0.31|||linear combination of coefficients|||effect of Zinc supplementation on ln(Triglycerides (mg/dL))||0.31|-0.17|0.58
72548744|NCT02016300|144626775|OTHER|||||||0.854|||||||Regression, Linear|||Difference between baseline and month 24.||||0.854
72548745|NCT02016300|144626776|OTHER|||||||0.774|||||||Regression, Linear|||Difference between baseline and month 12.||||0.774
72548746|NCT02016300|144626776|OTHER|||||||0.414|||||||Regression, Linear|||Difference between baseline and month 24.||||0.414
72548747|NCT02016300|144626777|OTHER|||||||0.064|||||||Regression, Linear|||Difference between baseline and month 12.||||0.064
72548748|NCT02016300|144626777|OTHER|||||||0.276|||||||Regression, Linear|||Difference between baseline and month 24.||||0.276
72548749|NCT02016300|144626778|OTHER|||||||0.02|||||||Regression, Linear|||Difference between baseline and month 12.||||0.020
72548750|NCT02016300|144626778|OTHER|||||||0.091|||||||Regression, Linear|||Difference between baseline and month 24.||||0.091
72548751|NCT00797108|144626814|SUPERIORITY_OR_OTHER||Clinical Cure Difference|27.5|||||TWO_SIDED|80.0|-4.0|55.3||||||Two-sided 80% confidence interval (CI) for the difference in the clinical cure response rates between treatement group and the comparator was formed using the exact methods.||55.3|-4.0|
72548752|NCT00797108|144626814|SUPERIORITY_OR_OTHER||Clinical Cure Difference|25.0|||||TWO_SIDED|80.0|-13.1|57.9||||||Two-sided 80% CI for the difference in the clinical cure response rates between treatement group and the comparator was formed using the exact methods.||57.9|-13.1|
72548753|NCT02270736|144626837|SUPERIORITY||Least square mean (LS-mean) difference|-0.06|STANDARD_ERROR_OF_MEAN|0.019|=|0.0012|TWO_SIDED|95.0|-0.1|-0.03|||MMRM|||Least square mean (LS-Mean) is from a mixed model repeated measurement (MMRM) analysis with treatment group, pooled investigation sites, and age groups as fixed factors, visit\*treatment as interaction term, visit as repeated factor, and baseline uSFR score as covariate.||-0.03|-0.1|= 0.0012
72548754|NCT02270736|144626838|SUPERIORITY||Least square mean (LS-mean) difference|0.28|STANDARD_ERROR_OF_MEAN|0.127|=|0.032|TWO_SIDED|95.0|0.02|0.53|||MMRM|||LS-Mean is from a MMRM analysis model with treatment group, pooled investigation sites, and age groups as fixed factors, visit\*treatment as interaction term, visit as repeated factor, and baseline Modified Teacher Drooling Scale (mTDS) score as covariate.||0.53|0.02|= 0.032
72548755|NCT02270736|144626840|SUPERIORITY||Least square mean (LS-mean) difference|-0.09|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001|TWO_SIDED|95.0|-0.12|-0.05|||MMRM|||Statistical analysis at Week 8: LS-Mean is from a MMRM analysis with treatment group, pooled investigation sites, and age groups as fixed factors, visit\*treatment as interaction term, visit as repeated factor, and baseline uSFR score as covariate.||-0.05|-0.12|<0.0001
72582263|NCT05085834|144695088|OTHER|Generalized estimating equations were used while adjusting for age and sex, and examining interactions between time and treatment. Combining linear coefficients in the equation while accounting for the multiplicative effects of treatment and time were considered to assess the true effect size of zinc supplementation on biomarkers.|β coefficient|-0.44|STANDARD_ERROR_OF_MEAN|0.47||0.35|TWO_SIDED|95.0|-1.36|0.48|||linear combination of coefficients|||effect of Zinc supplementation on Metabolic Syndrome||0.48|-1.36|0.35
72582264|NCT05085834|144695089|OTHER|Generalized estimating equations were used while adjusting for age and sex, and examining interactions between time and treatment. Combining linear coefficients in the equation while accounting for the multiplicative effects of treatment and time were considered to assess the true effect size of zinc supplementation on biomarkers.|β coefficient|0.06|STANDARD_ERROR_OF_MEAN|0.07||0.36|TWO_SIDED|95.0|-0.07|0.2|||linear combination of coefficients|||effect of Zinc supplementation on ln(Chol:HDL Ratio)||0.20|-0.07|0.36
72582265|NCT05085834|144695090|OTHER|Generalized estimating equations were used while adjusting for age and sex, and examining interactions between time and treatment. Combining linear coefficients in the equation while accounting for the multiplicative effects of treatment and time were considered to assess the true effect size of zinc supplementation on biomarkers.|β coefficient|-0.35|STANDARD_ERROR_OF_MEAN|2.01||0.86|TWO_SIDED|95.0|-4.29|3.6|||linear combination of coefficients|||effect of Zinc supplementation on BMI (kg/m2)||3.60|-4.29|0.86
72582266|NCT05085834|144695091|OTHER|Generalized estimating equations were used while adjusting for age and sex, and examining interactions between time and treatment. Combining linear coefficients in the equation while accounting for the multiplicative effects of treatment and time were considered to assess the true effect size of zinc supplementation on biomarkers.|β coefficient|-0.01|STANDARD_ERROR_OF_MEAN|0.03||0.74|TWO_SIDED|95.0|-0.08|0.05|||linear combination of coefficients|||effect of Zinc supplementation on ln(Waist-umbilicus (cm))||0.05|-0.08|0.74
72548756|NCT02270736|144626840|SUPERIORITY||Least square mean (LS-mean) difference|-0.1|STANDARD_ERROR_OF_MEAN|0.021|<|0.0001|TWO_SIDED|95.0|-0.14|-0.06|||MMRM|||Statistical analysis at Week 12: LS-Mean is from a MMRM analysis with treatment group, pooled investigation sites, and age groups as fixed factors, visit\*treatment as interaction term, visit as repeated factor, and baseline uSFR score as covariate.||-0.06|-0.14|<0.0001
72582267|NCT05085834|144695092|OTHER|Generalized estimating equations were used while adjusting for age and sex, and examining interactions between time and treatment. Combining linear coefficients in the equation while accounting for the multiplicative effects of treatment and time were considered to assess the true effect size of zinc supplementation on biomarkers.|β coefficient|-2.99|STANDARD_ERROR_OF_MEAN|12.23||0.81|TWO_SIDED|95.0|-26.97|20.99|||linear combination of coefficients|||effect of Zinc supplementation on Weight (lbs)||20.99|-26.97|0.81
72582268|NCT05085834|144695093|OTHER|Generalized estimating equations were used while adjusting for age and sex, and examining interactions between time and treatment. Combining linear coefficients in the equation while accounting for the multiplicative effects of treatment and time were considered to assess the true effect size of zinc supplementation on biomarkers.|β coefficient|-0.02|STANDARD_ERROR_OF_MEAN|0.03||0.41|TWO_SIDED|95.0|-0.07|0.03|||linear combination of coefficients|||effect of Zinc supplementation on ln(Systolic blood pressure (mmHg))||0.03|-0.07|0.41
72582269|NCT05085834|144695093|OTHER|Generalized estimating equations were used while adjusting for age and sex, and examining interactions between time and treatment. Combining linear coefficients in the equation while accounting for the multiplicative effects of treatment and time were considered to assess the true effect size of zinc supplementation on biomarkers.|β coefficient|-1.68|STANDARD_ERROR_OF_MEAN|2.06||0.42|TWO_SIDED|95.0|-5.71|2.36|||linear combination of coeff|||effect of Zinc supplementation on Diastolic blood pressure (mmHg)||2.36|-5.71|0.42
72548757|NCT02270736|144626841|SUPERIORITY||Least square mean (LS-mean) difference|0.4|STANDARD_ERROR_OF_MEAN|0.116|=|0.0008|TWO_SIDED|95.0|0.17|0.63|||MMRM|||Statistical analysis at Week 8: LS-Mean is from a MMRM analysis model with treatment group, pooled investigation sites, and age groups as fixed factors, visit\*treatment as interaction term, visit as repeated factor, and baseline mTDS score as covariate.||0.63|0.17|=0.0008
72548758|NCT02270736|144626841|SUPERIORITY||Least square mean (LS-mean) difference|0.4|STANDARD_ERROR_OF_MEAN|0.132|=|0.0026|TWO_SIDED|95.0|0.14|0.66|||MMRM|||Statistical analysis at Week 12: LS-Mean is from a MMRM analysis model with treatment group, pooled investigation sites, and age groups as fixed factors, visit\*treatment as interaction term, visit as repeated factor, and baseline mTDS score as covariate.||0.66|0.14|=0.0026
72548759|NCT04908748|144626855|SUPERIORITY||Least squares mean difference|-29.1|||<|0.0001|TWO_SIDED|95.0|-32.2|-26.0|||ANCOVA|||||-26.0|-32.2|< 0.0001
72548760|NCT00757601|144626872|NON_INFERIORITY_OR_EQUIVALENCE|"To assess the effect of food at the 30 mg dose, a point estimate was constructed for the geometric mean ratio for the fed/fasted states (GMR\[fed/fasted\]) of MK1006 AUC (0-∞).~The GMR (fed/fasted) was calculated using the geometric mean AUC (0-∞) of the fed state divided by the geometric mean AUC (0-∞) fasted state.~A GMR (fed/fasted) point estimate value within 20% of unity (1.00) was considered consistent with an absence of a clinically significant food effect."|Geometric Mean Ratio (fed/fasted)|1.03||||||95.0|||||Mixed-Effect Model|||A linear mixed-effect model was used to estimate the geometric mean AUC (0-∞) for MK1006 at every dose level.||||
72548761|NCT00757601|144626873|NON_INFERIORITY_OR_EQUIVALENCE|"To assess the effect of food at the 30 mg dose, a point estimate was constructed for the geometric mean ratio for the fed/fasted states (GMR\[fed/fasted\]) of MK1006 Cmax.~The GMR (fed/fasted) was calculated using the geometric mean Cmax of the fed state divided by the geometric mean Cmax fasted state.~A GMR (fed/fasted) point estimate value within 20% of unity (1.00) was considered consistent with an absence of a clinically significant food effect."|Geometric Mean Ratio (fed/fasted)|1.14||||||95.0|||||Mixed-effect Model|||A linear mixed-effect model was used to estimate the geometric mean Cmax for MK1006 at every dose level.||||
72548762|NCT03194464|144626881|OTHER|||||||0.15||||||The a priori threshold for statistical significance was established at p \<.05 (non-adjusted).|ANOVA|||We performed repeated measures analysis of variance (RM-ANOVA) to determine if intracortical inhibition, as measured by SICI, in the ipsilesional hemisphere was altered by less affected hand exercise to task-failure and to determine the time course and recovery of this effect.||||0.15
72548763|NCT03194464|144626882|SUPERIORITY|||||||0.83||||||Statistical Significance established as p \<.05|ANOVA|Repeated-Measures ANOVA||We performed repeated measures analysis of variance (RM-ANOVA) to determine if intracortical inhibition, as measured by SICI, in the ipsilesional hemisphere was altered by repeated sessions of less affected hand exercise to task-failure. Pre-exercise SICI was compared between Session1 and Session8.||||.83
72548764|NCT03194464|144626883|OTHER|||||||0.204|||||||ANOVA|||RM-ANOVA||||0.204
72548765|NCT03194464|144626884|SUPERIORITY|||||||0.004||||||statistical significance was established a priori at p \<.05|ANOVA|repeated measures ANOVA comparing Session8 vs. Session1 performance||We performed repeated measures analysis of variance (RM-ANOVA) to determine if motor dexterity, as measured by the BBT, was improved by repeated sessions of non-paretic hand exercise to task-failure. BBT performance was compared between Session1 and Session8.||||.004
72548766|NCT02606500|144626889|NON_INFERIORITY|We hypothesized that Elonva 150 mcg is non-inferior for COH in obese women.||||||0.9|||||||Regression, Logistic|||||||0.9
72548767|NCT02606500|144626890|NON_INFERIORITY|We hypothesized that Elonva 150 mcg is non-inferior for COH in obese women.||||||0.5|||||||Regression, Logistic|||||||0.5
72582270|NCT05085834|144695094|OTHER|Generalized estimating equations were used while adjusting for age and sex, and examining interactions between time and treatment. Combining linear coefficients in the equation while accounting for the multiplicative effects of treatment and time were considered to assess the true effect size of zinc supplementation on biomarkers.|β coefficient|-0.04|STANDARD_ERROR_OF_MEAN|0.11||0.7|TWO_SIDED|95.0|-0.26|0.17|||linear combination of coefficients|||effect of Zinc supplementation on ln(10 year ASCVD (%))||0.17|-0.26|0.70
72548768|NCT02606500|144626891|NON_INFERIORITY|We hypothesized that Elonva 150 mcg is non-inferior for COH in obese women.||||||0.3|||||||Regression, Logistic|||||||0.3
72548769|NCT02606500|144626892|NON_INFERIORITY|We hypothesized that Elonva 150 mcg is non-inferior for COH in obese women.||||||0.9|||||||Regression, Logistic|||||||0.9
72548770|NCT02606500|144626893|NON_INFERIORITY|We presumed Elonva 150 mcg in obese and normal weighing women yields comparable biochemical pregnancy rates.||||||0.4|||||||Regression, Logistic|||||||0.4
72548771|NCT02428699|144626953|SUPERIORITY||Mean Difference (Net)|5.16|||<|0.0001|TWO_SIDED|95.0|2.79|7.53|||ANCOVA|Subject as random effect,treatment and period as fixed effects,subject and period level baseline values for plasma total and free acids as covariates|Difference is test minus reference such that a positive difference favors the test treatment.|||7.53|2.79|<.0001
72548772|NCT02483975|144626979|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non inferiority was demonstrated if the lower limit of the two-sided 95% CI for the geometric mean ratio of each dose of fluticasone furoate 50 µg versus placebo was greater than 0.8.|Least square Geometric Mean ratio|0.92|||||TWO_SIDED|95.0|0.804|1.0505||||||||1.0505|0.8040|
72548773|NCT02483975|144626980|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non inferiority was demonstrated if the lower limit of the two-sided 95% CI for the geometric mean ratio of each dose of fluticasone furoate 50 µg versus placebo was greater than 0.8.|Least square Geometric Mean ratio|0.93|||||TWO_SIDED|95.0|0.8096|1.062||||||||1.0620|0.8096|
72548774|NCT02483975|144626981|SUPERIORITY_OR_OTHER_LEGACY||Least square Geometric Mean ratio|0.93|||||TWO_SIDED|95.0|0.81|1.06||||||||1.06|0.81|
72548775|NCT02483975|144626982|SUPERIORITY_OR_OTHER_LEGACY||Least square Geometric Mean ratio|0.79|||||TWO_SIDED|95.0|0.61|1.03||||||||1.03|0.61|
72548776|NCT02483975|144626983|SUPERIORITY_OR_OTHER_LEGACY||Least square Geometric Mean ratio|0.88|||||TWO_SIDED|95.0|0.72|1.07||||||||1.07|0.72|
72548777|NCT01193608|144627060|SUPERIORITY_OR_OTHER||Mean change|113.53||||0.599|TWO_SIDED|80.0|-170.3|397.35|||t-test, 2 sided||One sample paired t-test|Change from baseline, within group||397.35|-170.30|0.599
72548778|NCT01193608|144627062|SUPERIORITY_OR_OTHER||Mean change|48.85||||0.297|TWO_SIDED|80.0|-11.79|109.48|||t-test, 2 sided||One sample paired t-test|Change from baseline, within group||109.48|-11.79|0.297
72548779|NCT01193608|144627064|SUPERIORITY_OR_OTHER||Mean change|-15.26||||0.6|TWO_SIDED|80.0|-53.54|23.02|||t-test, 2 sided||One sample paired t-test|Change from baseline, within group||23.02|-53.54|0.600
72548780|NCT01193608|144627066|SUPERIORITY_OR_OTHER||Mean change|1.23||||0.603|TWO_SIDED|80.0|-1.89|4.35|||t-test, 2 sided||One sample paired t-test|Change from baseline, within group||4.35|-1.89|0.603
72582271|NCT05085834|144695095|OTHER|Generalized estimating equations were used while adjusting for age and sex, and examining interactions between time and treatment. Combining linear coefficients in the equation while accounting for the multiplicative effects of treatment and time were considered to assess the true effect size of zinc supplementation on biomarkers.|β coefficient|-0.03|STANDARD_ERROR_OF_MEAN|0.07||0.62|TWO_SIDED|95.0|-0.17|0.1|||linear combination of coefficients|||effect of Zinc supplementation on Reactive Hyperemic Index||0.10|-0.17|0.62
72582272|NCT05085834|144695095|OTHER|Generalized estimating equations were used while adjusting for age and sex, and examining interactions between time and treatment. Combining linear coefficients in the equation while accounting for the multiplicative effects of treatment and time were considered to assess the true effect size of zinc supplementation on biomarkers.|β coefficient|0.59|STANDARD_ERROR_OF_MEAN|2.43||0.81|TWO_SIDED|95.0|-4.19|5.36|||linear combination of coefficients|||effect of Zinc supplementation on Augmentation Index||5.36|-4.19|0.81
72582273|NCT05085834|144695096|OTHER|Generalized estimating equations were used while adjusting for age and sex, and examining interactions between time and treatment. Combining linear coefficients in the equation while accounting for the multiplicative effects of treatment and time were considered to assess the true effect size of zinc supplementation on biomarkers.|β coefficient|0.02|STANDARD_ERROR_OF_MEAN|0.14||0.9|TWO_SIDED|95.0|-0.26|0.3|||linear combination of coefficients|||effect of Zinc supplementation on ln(IFAB (pg/mL))||0.30|-0.26|0.90
72548781|NCT00948675|144627077|SUPERIORITY_OR_OTHER_LEGACY|||||||0.176||95.0|||||Log Rank|||||||0.176
72582274|NCT05085834|144695096|OTHER|Generalized estimating equations were used while adjusting for age and sex, and examining interactions between time and treatment. Combining linear coefficients in the equation while accounting for the multiplicative effects of treatment and time were considered to assess the true effect size of zinc supplementation on biomarkers.|β coefficient|0.18|STANDARD_ERROR_OF_MEAN|0.15||0.24|TWO_SIDED|95.0|-0.12|0.47|||linear combination of coefficients|||effect of Zinc supplementation on ln(BDG (pg/mL))||0.47|-0.12|0.24
72582275|NCT05085834|144695097|OTHER|Generalized estimating equations were used while adjusting for age and sex, and examining interactions between time and treatment. Combining linear coefficients in the equation while accounting for the multiplicative effects of treatment and time were considered to assess the true effect size of zinc supplementation on biomarkers.|β coefficient|0.05|STANDARD_ERROR_OF_MEAN|0.14||0.69|TWO_SIDED|95.0|-0.21|0.32|||v|||effect of Zinc supplementation on ln(LBP (ng/mL))||0.32|-0.21|0.69
72548782|NCT00948675|144627078|SUPERIORITY_OR_OTHER_LEGACY|||||||0.61||95.0|||||Log Rank|||||||0.610
72548783|NCT00948675|144627079|SUPERIORITY_OR_OTHER_LEGACY|||||||0.615||95.0|||||Log Rank|||||||0.615
72548784|NCT00948675|144627080|SUPERIORITY_OR_OTHER_LEGACY|||||||0.414||95.0|||||Pearson Chi-square Test|||||||0.414
72548785|NCT00948675|144627081|SUPERIORITY_OR_OTHER_LEGACY|||||||0.575||95.0|||||Pearson Chi-square Test|||||||0.575
72548786|NCT00571428|144627109|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence was defined a priori such that 90%CI for the difference between therapies had to fall entirely within +/- 0.07L.|Mean Difference (Final Values)|0.011||||||90.0|-0.015|0.037|||Mixed Models Analysis|Treatment group, treatment sequence, predose FEV1, \& Visit number are fixed effects; subject within treatment sequence is a random effect.||||0.037|-0.015|
72548787|NCT00571428|144627110|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence was defined a priori such that 90%CI for the difference between therapies has to fall entirely within +/- 0.07L.|Mean Difference (Final Values)|0.062||||||90.0|0.035|0.09|||Mixed Models Analysis|Treatment group, treatment sequence, pre-dose FEV1, \& Visit Number are fixed effects; subjects within treatment sequence is a random effect.||||0.090|0.035|
72582276|NCT05085834|144695097|OTHER|Generalized estimating equations were used while adjusting for age and sex, and examining interactions between time and treatment. Combining linear coefficients in the equation while accounting for the multiplicative effects of treatment and time were considered to assess the true effect size of zinc supplementation on biomarkers.|β coefficient|0.09|STANDARD_ERROR_OF_MEAN|0.13||0.49|TWO_SIDED|95.0|-0.16|0.34|||linear combination of coefficients|||effect of Zinc supplementation on ln(Zonulin (ng/mL)||0.34|-0.16|0.49
72582277|NCT02157935|144695106|SUPERIORITY_OR_OTHER||Rate ratio|0.76||||0.0059|TWO_SIDED|95.0|0.62|0.92|||Negative binomial model|||||0.92|0.62|0.0059
72582278|NCT02157935|144695107|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.78||||0.0164|TWO_SIDED|95.0|0.64|0.96|||Regression, Cox|||||0.96|0.64|0.0164
72582279|NCT02157935|144695108|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.343||||0.007|TWO_SIDED|95.0|-2.318|-0.368|||Mixed Models Analysis|||||-0.368|-2.318|0.0070
72412545|NCT03029208|144333157|SUPERIORITY||LS mean difference|-6.43||||0.9875|TWO_SIDED|95.0|-12.05|-0.82|||MMRM||Tired/Low energy/Weak domain: MMRM model was fitted from Baseline up to Week 52 with factors for treatment, time, dialysis type, dialysis start manner, Baseline value and Baseline value by time and treatment by time interactions.|||-0.82|-12.05|0.9875
72412546|NCT03029208|144333157|SUPERIORITY||LS mean difference|-4.11||||0.9663|TWO_SIDED|95.0|-8.52|0.3|||MMRM||Chest pain/Shortness of breath domain: MMRM model was fitted from Baseline up to Week 52 with factors for treatment, time, dialysis type, dialysis start manner, Baseline value and Baseline value by time and treatment by time interactions.|||0.30|-8.52|0.9663
72412547|NCT03029208|144333157|SUPERIORITY||LS mean difference|-6.6||||0.993|TWO_SIDED|95.0|-11.84|-1.35|||MMRM||Cognitive domain: MMRM model was fitted from Baseline up to Week 52 with factors for treatment, time, dialysis type, dialysis start manner, Baseline value and Baseline value by time and treatment by time interactions.|||-1.35|-11.84|0.9930
72412548|NCT03029208|144333157|SUPERIORITY||LS mean difference|-3.03||||0.8765|TWO_SIDED|95.0|-8.19|2.12|||MMRM||Shortness of breath, no activity: MMRM model was fitted from Baseline up to Week 52 with factors for treatment, time, dialysis type, dialysis start manner, Baseline value and Baseline value by time and treatment by time interactions.|||2.12|-8.19|0.8765
72412549|NCT03029208|144333157|SUPERIORITY||LS mean difference|-4.27||||0.9464|TWO_SIDED|95.0|-9.48|0.94|||MMRM||Severity-short breath, Resting: MMRM model was fitted from Baseline up to Week 52 with factors for treatment, time, dialysis type, dialysis start manner, Baseline value and Baseline value by time and treatment by time interactions.|||0.94|-9.48|0.9464
72412550|NCT03029208|144333157|SUPERIORITY||LS mean difference|-5.31||||0.9101|TWO_SIDED|95.0|-13.09|2.47|||MMRM||Difficulty standing for long time: MMRM model was fitted from Baseline up to Week 52 with factors for treatment, time, dialysis type, dialysis start manner, Baseline value and Baseline value by time and treatment by time interactions.|||2.47|-13.09|0.9101
72412551|NCT03029208|144333157|SUPERIORITY||LS mean difference|-6.52||||0.9586|TWO_SIDED|95.0|-13.9|0.86|||MMRM||Difficulty sleeping: MMRM model was fitted from Baseline up to Week 52 with factors for treatment, time, dialysis type, dialysis start manner, Baseline value and Baseline value by time and treatment by time interactions.|||0.86|-13.90|0.9586
72412552|NCT03029208|144333158|SUPERIORITY||LS mean difference|0.27||||0.981|TWO_SIDED|95.0|0.02|0.53|||MMRM||MMRM model was fitted from Baseline up to Week 8 with factors for treatment, time, dialysis type, dialysis start manner, Baseline value and Baseline value by time and treatment by time interactions.|||0.53|0.02|0.9810
72412553|NCT03029208|144333158|SUPERIORITY||LS mean difference|0.05||||0.6743|TWO_SIDED|95.0|-0.17|0.26|||MMRM||MMRM model was fitted from Baseline up to Week 12 with factors for treatment, time, dialysis type, dialysis start manner, Baseline value and Baseline value by time and treatment by time interactions.|||0.26|-0.17|0.6743
72548788|NCT00571428|144627111|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence was defined a priori such that 90%CI for the difference between therapies has to fall entirely within +/- 0.07L.|Median Difference (Final Values)|-0.035||||||90.0|-0.079|0.008|||Mixed Models Analysis|Treatment group, treatment sequence, pre-dose FEV1, \& Visit Number are fixed effects; subjects within treatment sequence is a random effect.||||0.008|-0.079|
72582280|NCT02157935|144695109|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.03||||0.0091|TWO_SIDED|95.0|0.008|0.053|||Mixed Models Analysis|||||0.053|0.008|0.0091
72412554|NCT03029208|144333158|SUPERIORITY||LS mean difference|0.16||||0.8997|TWO_SIDED|95.0|-0.09|0.4|||MMRM||MMRM model was fitted from Baseline up to Week 28 with factors for treatment, time, dialysis type, dialysis start manner, Baseline value and Baseline value by time and treatment by time interactions.|||0.40|-0.09|0.8997
72412555|NCT03029208|144333158|SUPERIORITY||LS mean difference|0.18||||0.8835|TWO_SIDED|95.0|-0.12|0.47|||MMRM||MMRM model was fitted from Baseline up to Week 52 with factors for treatment, time, dialysis type, dialysis start manner, Baseline value and Baseline value by time and treatment by time interactions.|||0.47|-0.12|0.8835
72412556|NCT01046643|144333202|SUPERIORITY_OR_OTHER|||||||0.222||95.0||||Category = Medial Frontal Cortex|t-test, 2 sided|||"Category = Medial Frontal Cortex~p-value for null hypothesis = \<0.05"||||.222
72412557|NCT01046643|144333202|SUPERIORITY_OR_OTHER|||||||0.107||95.0||||Category = Left Hippocampus|t-test, 2 sided|||"Category = Left Hippocampus~p-value for null hypothesis = \<0.05"||||.107
72412558|NCT01046643|144333202|SUPERIORITY_OR_OTHER|||||||0.127||95.0||||Category = Medial Frontal Cortex|t-test, 2 sided|||"Category = Right Hippocampus~p-value for null hypothesis = \<0.05"||||.127
72412559|NCT01046643|144333202|SUPERIORITY_OR_OTHER|||||||0.954||95.0||||Category = Medial Frontal Cortex|t-test, 2 sided|||"Category = Medial Frontal Cortex~p-value for null hypothesis = \<0.05"||||.954
72412560|NCT01046643|144333202|SUPERIORITY_OR_OTHER|||||||0.385||95.0||||Category = Left Hippocampus|t-test, 2 sided|||"Category = Left Hippocampus~p-value for null hypothesis = \<0.05"||||.385
72412561|NCT01046643|144333202|SUPERIORITY_OR_OTHER|||||||0.31||95.0||||Category = Right Hippocampus|t-test, 2 sided|||"Category = Right Hippocampus~p-value for null hypothesis = \<0.05"||||.310
72412562|NCT01046643|144333203|SUPERIORITY_OR_OTHER|||||||0.594||95.0|||||t-test, 2 sided|||p-value for null hypothesis = \<0.05||||.594
72412563|NCT01046643|144333203|SUPERIORITY_OR_OTHER|||||||0.653||95.0|||||t-test, 2 sided|||p-value for null hypothesis = \<0.05||||.653
72412564|NCT01046643|144333204|SUPERIORITY_OR_OTHER|||||||0.452||95.0||||Category = Medial Frontal Cortex|t-test, 2 sided|||"Category = Medial Frontal Cortex~p-value for null hypothesis = \<0.05"||||.452
72412565|NCT01046643|144333204|SUPERIORITY_OR_OTHER|||||||0.868||95.0||||Category = Left Hippocampus|t-test, 2 sided|||"Category = Left Hippocampus~p-value for null hypothesis = \<0.05"||||.868
72548789|NCT00571428|144627112|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence was defined a priori such that 90%CI for the difference between therapies has to fall entirely within +/- 0.07L.|Median Difference (Final Values)|-0.03||||||90.0|-0.086|0.026|||Mixed Models Analysis|Treatment group, treatment sequence, pre-dose FEV1, \& Visit Number are fixed effects; subjects within treatment sequence is a random effect.||||0.026|-0.086|
72548790|NCT00571428|144627117|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.694||||||90.0|0.525|2.862|||Mixed Models Analysis|Treatment group, treatment sequence, pre-dose FEV1, \& Visit number are fixed effects; subject within treatment sequence is a random effect.||||2.862|0.525|
72582281|NCT02157935|144695110|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.203||||0.0082|TWO_SIDED|95.0|-0.353|-0.053|||ANCOVA|||||-0.053|-0.353|0.0082
72582282|NCT02157935|144695111|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.028||||0.0048|TWO_SIDED|95.0|-0.048|-0.009|||ANCOVA|||||-0.009|-0.048|0.0048
72412566|NCT01046643|144333204|SUPERIORITY_OR_OTHER|||||||0.549||95.0||||Category = Right Hippocampus|t-test, 2 sided|||"Category = Right Hippocampus~p-value for null hypothesis = \<0.05"||||.549
72412567|NCT01046643|144333204|SUPERIORITY_OR_OTHER|||||||0.124||95.0||||Category = Medial Frontal Cortex|t-test, 2 sided|||"Category = Medial Frontal Cortex~p-value for null hypothesis = \<0.05"||||.124
72412568|NCT01046643|144333204|SUPERIORITY_OR_OTHER|||||||0.158||95.0||||Category = Left Hippocampus|t-test, 2 sided|||"Category = Left Hippocampus~p-value for null hypothesis = \<0.05"||||.158
72412569|NCT01046643|144333204|SUPERIORITY_OR_OTHER|||||||0.055||95.0||||Category = Right Hippocampus|t-test, 2 sided|||"Category = Right Hippocampus~p-value for null hypothesis = \<0.05"||||.055
72412570|NCT01046643|144333205|SUPERIORITY_OR_OTHER|||||||0.561||95.0|||||t-test, 2 sided|||p-value for null hypothesis = \<0.05||||.561
72412571|NCT01046643|144333205|SUPERIORITY_OR_OTHER|||||||0.726||95.0|||||t-test, 2 sided|||p-value for null hypothesis = \<0.05||||.726
72412572|NCT00289341|144333206|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||Fisher Exact|||for injection site reaction only||||0.001
72412573|NCT00289341|144333206|SUPERIORITY_OR_OTHER||||||>|0.2||95.0|||||Fisher Exact|||for all other adverse events||||>0.2
72548791|NCT00571428|144627118|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence was defined a priori such that 90%CI for the difference between therapies had to fall entirely within +/- 0.07L.|Mean Difference (Final Values)|0.052||||||90.0|0.015|0.09|||Mixed Models Analysis|Treatment group, treatment sequence, pre-dose FEV1, \& Visit number are fixed effects; subject within treatment sequence is a random effect||||0.090|0.015|
72582283|NCT00572936|144695112|EQUIVALENCE|ANOVA was performed to compare the results between the three interventions.|||||<|0.05||||||threshold for significance was \<0.05|ANOVA|||||||<.05
72412574|NCT00289341|144333208|SUPERIORITY_OR_OTHER|||||||0.016||95.0|||||Linear Spline model|||||||0.016
72412575|NCT02371369|144333226|OTHER|Treatment comparison analysis|||||<|0.0001|||||||Fisher's Exact Test|||Treatment comparison between the pexidartinib and placebo groups at Week 25||||<0.0001
72412576|NCT02371369|144333227|OTHER|Treatment comparison analysis||||||0.0043|||||||Fisher's Exact Test|||Treatment comparison between the pexidartinib and placebo groups at Week 25||||0.0043
72548792|NCT04087395|144627123|NON_INFERIORITY|To achieve non-inferiority, the observed p-value must be \<= 0.5 taking into account of the non-inferiority margin (i.e., 10mm difference in Pain VAS between the two treatment groups).|||||<|0.0001||||||One-sided paired student t-test|t-test, 1 sided|||||||<0.0001
72548793|NCT01089647|144627137|OTHER||||||=|0.946|||||||ANOVA|||Between-group comparisons at follow-up were made using a stepwise multivariable logistic model.||||=0.946
72412577|NCT02371369|144333228|OTHER|Treatment comparison analysis|||||<|0.0001|||||||Fisher's Exact Test|||Treatment comparison between the pexidartinib and placebo groups at Week 25||||<0.0001
72412578|NCT02371369|144333229|OTHER|Treatment comparison analysis||||||0.0019|||||||Mixed effects model for repeated measure|||Treatment comparison between pexidartinib and placebo groups at Week 25||||0.0019
72548794|NCT00995553|144627138|SUPERIORITY_OR_OTHER|||||||0.06|TWO_SIDED||||||ANOVA|||MATRICS Working Memory Index||||.06
72548795|NCT00995553|144627138|SUPERIORITY_OR_OTHER|||||||0.09|TWO_SIDED||||||ANOVA|||MATRICS Attention Index||||.09
72412579|NCT02371369|144333230|OTHER|Treatment comparison analysis|||||<|0.0001|||||||Mixed effects model for repeated measure|||Treatment comparison between the pexidartinib and placebo groups at Week 25||||<0.0001
72412580|NCT04307186|144333262|OTHER|"McNemar test was used for the exploratory analysis of difference between the percentage of participants greatly prefer/prefer gadoquatrane and greatly prefer/prefer gadobutrol."|||||<|0.0001||||||P-Value was calculated. p \< 0.05 indicates a difference between the two reads; p \> 0.05 indicates the observed data do not contradict equality.|McNemar|||Reader 1||||<0.0001
72412581|NCT04307186|144333262|OTHER|"McNemar test was used for the exploratory analysis of difference between the percentage of participants greatly prefer/prefer gadoquatrane and greatly prefer/prefer gadobutrol."||||||0.5775||||||P-Value was calculated. p \< 0.05 indicates a difference between the two reads; p \> 0.05 indicates the observed data do not contradict equality.|McNemar|||Reader 2||||0.5775
72412582|NCT04307186|144333262|OTHER|"McNemar test was used for the exploratory analysis of difference between the percentage of participants greatly prefer/prefer gadoquatrane and greatly prefer/prefer gadobutrol."||||||0.3173||||||P-Value was calculated. p \< 0.05 indicates a difference between the two reads; p \> 0.05 indicates the observed data do not contradict equality.|McNemar|||Reader 3||||0.3173
72412583|NCT04307186|144333263|NON_INFERIORITY|The non-inferiority of gadoquatrane versus gadobutrol was evaluated using CIs based on the t-distribution. A non-inferiority margin of 1 was used, i.e. meaning that a 95% two-sided CI for the mean difference gadoquatrane minus gadobutrol score must exclude the value -1.|Mean Difference (Final Values)|-0.05|||<|0.0001|TWO_SIDED|95.0|-0.24|0.13||P-Value was calculated. Non-inferiority was achieved with a one-sided p-value lower than 0.025.|t-test, 1 sided|||Average reader||0.13|-0.24|<0.0001
72412584|NCT04307186|144333264|OTHER|95% two-sided CIs based on a t-distribution for the difference of combined pre- and post-contrast minus pre-contrast scores.|Mean Difference (Final Values)|1.2|||||TWO_SIDED|95.0|1.06|1.34|||||Descriptive comparison of the result following gadobutrol with the result following gadoquatrane.|Average Reader||1.34|1.06|
72412585|NCT04307186|144333264|OTHER|95% two-sided CIs based on a t-distribution for the difference of combined pre- and post-contrast minus pre-contrast scores.|Mean Difference (Final Values)|1.1|||||TWO_SIDED|95.0|0.94|1.25|||||Descriptive comparison of the result following gadobutrol with the result following gadoquatrane.|Average Reader||1.25|0.94|
72412586|NCT04307186|144333265|OTHER|95% two-sided CIs based on a t-distribution for the difference of combined pre- and post-contrast minus pre-contrast scores.|Mean Difference (Final Values)|2.07|||||TWO_SIDED|95.0|1.87|2.28|||||Descriptive comparison of the result following gadobutrol with the result following gadoquatrane.|Average Reader||2.28|1.87|
72548796|NCT00995553|144627139|SUPERIORITY_OR_OTHER|||||||0.73|||||||ANOVA|||||||.73
72582284|NCT00572936|144695113|EQUIVALENCE|ANOVA was performed to compare the results between the three interventions.|||||<|0.05||||||threshold for statistical significance was \<0.05|ANOVA|||||||<0.05
72582285|NCT00572936|144695114|EQUIVALENCE|ANOVA was performed to compare the results between the three interventions.||||||0.93||||||threshold for statistical significance was \<0.05|ANOVA|||||||0.93
72582286|NCT00572936|144695115|EQUIVALENCE|ANOVA was performed to compare the results between the three interventions.||||||0.84||||||threshold for statistical significance was \<0.05|ANOVA|||||||0.84
72548797|NCT03587207|144627197|OTHER|rMenBOMV+ACWY\_S is to be declared statistically inferior if the 2-sided 80% CIs of the between group ratio of the GMT with rMenBOMV+ACWY\_D as control is lower than 1 at 1 month after last vaccination. The following ANCOVA model is used: fixed-effect model including age strata, study group, strain and center as fixed effects. The pre vaccination (Baseline) log-transformed titer with centering at zero is included as a continuous covariate.|Geometric mean ratio|0.96|||||TWO_SIDED|80.0|0.83|1.1|||ANCOVA|An interaction between strain and pre-vaccination log transformed titer is included in the model to fit to the serogroup B test strain data only.||Immune interference due to stress to lymph nodes (lymph-node effect) in rMenBOMV+ACWY\_S versus rMenBOMV+ACWY\_D study groups, on the pooled B strains, one month after last vaccination.||1.10|0.83|
72582287|NCT00572936|144695116|EQUIVALENCE|ANOVA was performed to compare the results between the three interventions.|||||<|0.05||||||threshold for statistical significance was \<0.05|ANOVA|||||||<0.05
72548798|NCT03587207|144627198|OTHER|M14459 strain-Between group ratios for comparison of rMenBOMV+ACWY\_S and rMenBOMV+ACWY\_D groups|Geometric mean ratio|1.0|||||TWO_SIDED|80.0|0.84|1.2|||ANCOVA|The model is fitted to each serogroup/strain separately.||Immune interference due to stress to lymph nodes (lymph-node effect) in rMenBOMV+ACWY\_S versus rMenBOMV+ACWY\_D study groups, on the Meningitis B M14459 (fHbp) strain, one month after last vaccination.||1.20|0.84|
72548799|NCT03587207|144627198|OTHER|96217 strain-Between group ratios for comparison of rMenBOMV+ACWY\_S and rMenBOMV+ACWY\_D groups|Geometric mean ratio|1.05||||||80.0|0.88|1.26|||ANCOVA|The model is fitted to each serogroup/strain separately.||Immune interference due to stress to lymph nodes (lymph-node effect) in rMenBOMV+ACWY\_S versus rMenBOMV+ACWY\_D study groups, on the Meningitis B 96217 (NadA) strain, one month after last vaccination.||1.26|0.88|
72582288|NCT00572936|144695117|EQUIVALENCE|ANOVA was performed to compare the results between the three interventions.||||||0.89||||||threshold for statistical significance was \<0.05|ANOVA|||||||0.89
72582289|NCT00572936|144695118|EQUIVALENCE|Kruskal-Wallis test was used to compare the differences between outflow facility for the three interventions|||||<|0.05||||||threshold for statistical significance was \<0.05|Kruskal-Wallis|||||||<0.05
72582290|NCT00572936|144695119|EQUIVALENCE|Kruskal-Wallis test was used to compare the differences in uveoscleral outflow between the three interventions|||||<|0.05||||||threshold for statistical analysis was \<0.05|Kruskal-Wallis|||||||<0.05
72582291|NCT02547428|144695120|SUPERIORITY||Treatment difference|-8.1|STANDARD_ERROR_OF_MEAN|1.48|<|0.001|TWO_SIDED|95.0|-11.0|-5.1|||ANCOVA||Sample size of 60 participants (30 per treatment sequence) was needed to provide minimum 85% power to detect 5 point difference between treatments at a 2-sided significance level of 5% using a paired t-test.|Null hypothesis was that there was no difference in ADHD-RS-IV total score change from Baseline between CTN SR and placebo. The analysis of covariance (ANCOVA) model included terms for period, sequence, and treatment as fixed effects, and Baseline score as a covariate, and a participate-within-sequence term as a random effect.||-5.1|-11.0|<0.001
72582292|NCT02547428|144695121|SUPERIORITY||Treatment difference|-7.1|STANDARD_ERROR_OF_MEAN|1.74|<|0.001|TWO_SIDED|95.0|-10.7|-3.6|||ANCOVA|||Null hypothesis was that there was no difference in ADHD-RS-IV total score change from Baseline between CTN SR 400 mg/day and placebo.||-3.6|-10.7|<0.001
72582293|NCT01479465|144695142|SUPERIORITY||Hazard Ratio (HR)|1.45||||0.0395|TWO_SIDED|95.0|1.01|2.06|||Log Rank|||"The null hypothesis was that the hazard ratio (HR) equals to 1 between SIM treatment arm and placebo, while the alternative hypothesis was that HR was less than 1.~The HR (95% confidence interval \[CI\]) and p-value (for comparison between SIM treatment arm and placebo) were based on two-sided log-rank test, stratified based on the 2-level Eastern Cooperative Oncology Group (ECOG) performance status (0 or \> 0) at randomization."||2.06|1.01|0.0395
72582294|NCT01479465|144695142|SUPERIORITY||Hazard Ratio (HR)|1.32||||0.1042|TWO_SIDED|95.0|0.92|1.89|||Log Rank|||"The null hypothesis was that the HR equals to 1 between SIM treatment arm and placebo, while the alternative hypothesis was that HR was less than 1.~The HR (95% CI) and p-value (for comparison between SIM treatment arm and placebo) were based on two-sided log-rank test, stratified based on the 2-level ECOG performance status (0 or \> 0) at randomization."||1.89|0.92|0.1042
72582295|NCT02806908|144695145|SUPERIORITY|||||||0.0022|||||||ANOVA|||||||0.0022
72582296|NCT02806908|144695146|SUPERIORITY|||||||0.0416|||||||ANOVA|||||||0.0416
72582297|NCT02806908|144695147|SUPERIORITY|||||||0.0963|||||||McNemar|||||||0.0963
72582298|NCT02806908|144695148|SUPERIORITY|||||||0.3018|||||||McNemar|||||||0.3018
72582299|NCT02806908|144695149|SUPERIORITY|||||||0.424|||||||McNemar|||||||0.4240
72582300|NCT02806908|144695150|SUPERIORITY|||||||0.7539|||||||McNemar|||||||0.7539
72582301|NCT02806908|144695151|SUPERIORITY|||||||0.7539|||||||McNemar|||||||0.7539
72582302|NCT02806908|144695152|SUPERIORITY|||||||1|||||||McNemar|||||||1.0000
72582303|NCT02806908|144695153|SUPERIORITY|||||||0.6291|||||||McNemar|||||||0.6291
72582304|NCT02806908|144695154|SUPERIORITY|||||||1|||||||McNemar|||||||1.0000
72582305|NCT02806908|144695155|SUPERIORITY|||||||1|||||||McNemar|||||||1.0000
72582306|NCT02806908|144695156|SUPERIORITY|||||||1|||||||McNemar|||||||1.0000
72582307|NCT02806908|144695157|SUPERIORITY|||||||0.7744|||||||McNemar|||||||0.7744
72582308|NCT02806908|144695158|SUPERIORITY|||||||0.7539|||||||McNemar|||||||0.7539
72582309|NCT02806908|144695159|SUPERIORITY|||||||0.1141|||||||ANOVA|||||||0.1141
72582310|NCT02806908|144695160|SUPERIORITY|||||||0.4441|||||||ANOVA|||||||0.4441
72582311|NCT02806908|144695161|SUPERIORITY|||||||0.3423|||||||ANOVA|||||||0.3423
72582312|NCT02806908|144695162|SUPERIORITY|||||||0.9384|||||||ANOVA|||||||0.9384
72582313|NCT02806908|144695163|SUPERIORITY|||||||0.0939|||||||ANOVA|||||||0.0939
72582314|NCT02806908|144695164|SUPERIORITY|||||||0.0246|||||||ANOVA|||||||0.0246
72582315|NCT02806908|144695165|SUPERIORITY|||||||0.1475|||||||ANOVA|||||||0.1475
72582316|NCT02806908|144695166|SUPERIORITY|||||||0.1513|||||||ANOVA|||||||0.1513
72582317|NCT02806908|144695167|SUPERIORITY|||||||0.0002|||||||ANOVA|||||||0.0002
72548800|NCT03587207|144627198|OTHER|NZ98/254 strain-Between group ratios for comparison of rMenBOMV+ACWY\_S and rMenBOMV+ACWY\_D groups|Geometric mean ratio|0.78|||||TWO_SIDED|80.0|0.64|0.95|||ANCOVA|The model is fitted to each serogroup/strain separately.||Immune interference due to stress to lymph nodes (lymph-node effect) in rMenBOMV+ACWY\_S versus rMenBOMV+ACWY\_D study groups, on the Meningitis B NZ98/254 (PorA) strain, one month after last vaccination.||0.95|0.64|
72548801|NCT03587207|144627198|OTHER|M07-0241084 strain- Between group ratios for comparison of rMenBOMV\_ACWY\_S group and rMenBOMV+ACWY\_D group|Geometric mean ratio|0.8|||||TWO_SIDED|80.0|0.66|0.96|||ANCOVA|The model is fitted to each serogroup/strain separately.||Immune interference due to stress to lymph nodes (lymph-node effect) in rMenBOMV+ACWY\_S versus rMenBOMV+ACWY\_D study groups, on the Meningitis B M07-0241084 (NHBA) strain, one month after last vaccination.||0.96|0.66|
72548802|NCT03587207|144627198|OTHER|Serogroup A- Between group ratio for comparison of rMenBOMV+ACWY\_S group and rMenBOMV+ACWY\_D group|Geometric mean ratio|0.92|||||TWO_SIDED|80.0|0.74|1.14|||ANCOVA|The model is fitted to each serogroup/strain separately.||Immune interference due to stress to lymph nodes (lymph-node effect) in rMenBOMV+ACWY\_S versus rMenBOMV+ACWY\_D study groups, on the Meningitis serogroup A, one month after last vaccination.||1.14|0.74|
72582318|NCT02806908|144695168|SUPERIORITY|||||||0.0005|||||||ANOVA|||||||0.0005
72412587|NCT04307186|144333265|OTHER|95% two-sided CIs based on a t-distribution for the difference of combined pre- and post-contrast minus pre-contrast scores.|Mean Difference (Final Values)|2.06|||||TWO_SIDED|95.0|1.86|2.25|||||Descriptive comparison of the result following gadobutrol with the result following gadoquatrane.|Average Reader||2.25|1.86|
72548803|NCT03587207|144627198|OTHER|Serogroup C- Between group ratio for comparison of rMenBOMV+ACWY\_S group and rMenBOMV+ACWY\_D group|Geometric mean ratio|1.0|||||TWO_SIDED|80.0|0.78|1.27|||ANCOVA|The model is fitted to each serogroup/strain separately.||Immune interference due to stress to lymph nodes (lymph-node effect) in rMenBOMV+ACWY\_S versus rMenBOMV+ACWY\_D study groups, on the Meningitis serogroup C, one month after last vaccination.||1.27|0.78|
72548804|NCT03587207|144627198|OTHER|Serogroup W- Between group ratios for comparison of rMenBOMV+ACWY\_S group and rMenBOMV+ACWY\_D group|Geometric mean ratio|0.97|||||TWO_SIDED|80.0|0.79|1.18|||ANCOVA|The model is fitted to each serogroup/strain separately.||Immune interference due to stress to lymph nodes (lymph-node effect) in rMenBOMV+ACWY\_S versus rMenBOMV+ACWY\_D study groups, on the Meningitis serogroup W, one month after last vaccination.||1.18|0.79|
72548805|NCT03587207|144627198|OTHER|Serogroup Y- Between group ratio for comparison of rMenBOMV+ACWY\_S group and rMenBOMV+ACWY\_D group|Geometric mean ratio|0.91|||||TWO_SIDED|80.0|0.69|1.19|||ANCOVA|The model is fitted to each serogroup/strain separately.||Immune interference due to stress to lymph nodes (lymph-node effect) in rMenBOMV+ACWY\_S versus rMenBOMV+ACWY\_D study groups, on the Meningitis serogroup Y, one month after last vaccination.||1.19|0.69|
72548806|NCT03587207|144627198|OTHER|M14459 strain- Between group ratio for comparison of MenABCWY group and rMenBOMV+ACWY\_S group.|Geometric mean ratio|1.02|||||TWO_SIDED|80.0|0.86|1.22|||ANCOVA|The model is fitted to each serogroup/strain separately.||Other unknown interference in MenABCWY versus rMenBOMV+ACWY\_S study groups, on the Meningitis B M14459 (fHbp) strain, one month after last vaccination.||1.22|0.86|
72548807|NCT03587207|144627198|OTHER|96217 strain- Between group ratio for comparison of MenABCWY group and rMenBOMV+ACWY\_S group.|Geometric mean ratio|0.79|||||TWO_SIDED|80.0|0.66|0.95|||ANCOVA|The model is fitted to each serogroup/strain separately.||Other unknown interference in MenABCWY versus rMenBOMV+ACWY\_S study groups, on the Meningitis B 96217 (NadA)strain, one month after last vaccination.||0.95|0.66|
72548808|NCT03587207|144627198|OTHER|NZ98/254 strain- Between group ratio for comparison of MenABCWY group and rMenBOMV+ACWY\_S group.|Geometric mean ratio|0.79|||||TWO_SIDED|80.0|0.65|0.97|||ANCOVA|The model is fitted to each serogroup/strain separately.||Other unknown interference in MenABCWY versus rMenBOMV+ACWY\_S study groups, on the Meningitis B NZ98/254 (PorA) strain, one month after last vaccination.||0.97|0.65|
72548809|NCT03587207|144627198|NON_INFERIORITY|M07-0241084 strain- Between group ratio for comparison of MenABCWY group and rMenBOMV+ACWY\_S group.|Geometric mean ratio|0.73|||||TWO_SIDED|80.0|0.6|0.88|||ANCOVA|The model is fitted to each serogroup/strain separately.||Other unknown interference in MenABCWY versus rMenBOMV+ACWY\_S study groups, on the Meningitis B M07-0241084 (NHBA) strain, one month after last vaccination.||0.88|0.60|
72548810|NCT03587207|144627198|OTHER|Serogroup A- Between group ratio for comparison of MenABCWY group and rMenBOMV+ACWY\_S group.|Geometric mean ratio|0.56|||||TWO_SIDED|80.0|0.45|0.69|||ANCOVA|The model is fitted to each serogroup/strain separately.||Other unknown interference in MenABCWY versus rMenBOMV+ACWY\_S study groups, on the Meningitis serogrpoup A, one month after last vaccination.||0.69|0.45|
72548811|NCT03587207|144627198|OTHER|Serogroup C- Between group ratio for comparison of MenABCWY group and rMenBOMV+ACWY\_S group.|Geometric mean ratio|1.19|||||TWO_SIDED|80.0|0.94|1.52|||ANCOVA|The model is fitted to each serogroup/strain separately.||Other unknown interference in MenABCWY versus rMenBOMV+ACWY\_S study groups, on the Meningitis serogroup C, one month after last vaccination.||1.52|0.94|
72548812|NCT03587207|144627198|OTHER|Serogroup W- Between group ratio for comparison of MenABCWY group and rMenBOMV+ACWY\_S group.|Geometric mean ratio|1.06|||||TWO_SIDED|80.0|0.87|1.29|||ANCOVA|The model is fitted to each serogroup/strain separately.||Other unknown interference in MenABCWY versus rMenBOMV+ACWY\_S study groups, on the Meningitis serogroup W, one month after last vaccination.||1.29|0.87|
72548813|NCT03587207|144627198|OTHER|Serogroup Y- Between group ratio for comparison of MenABCWY group and rMenBOMV+ACWY\_S group.|Geometric mean ratio|1.18|||||TWO_SIDED|80.0|0.9|1.55|||ANCOVA|The model is fitted to each serogroup/strain separately.||Other unknown interference in MenABCWY versus rMenBOMV+ACWY\_S study groups, on the Meningitis serogroup Y, one month after last vaccination.||1.55|0.90|
72582319|NCT02806908|144695169|SUPERIORITY|||||||0.4774|||||||ANOVA|||||||0.4774
72582320|NCT02806908|144695170|SUPERIORITY|||||||0.3801|||||||ANOVA|||||||0.3801
72582321|NCT02806908|144695171|SUPERIORITY||||||<|0.0001|||||||ANOVA|||||||<0.0001
72582322|NCT01760304|144695172|SUPERIORITY|||||||0.769|||||||2-sided paired t-test|||a paired t-test was calculated comparing baseline measures and post intervention||||0.769
72582323|NCT01760304|144695172|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||paired T-test|||a paired t-test was calculated comparing baseline measures and post intervention||||<0.0001
72412588|NCT04307186|144333266|OTHER|95% two-sided CIs based on a t-distribution for the difference of combined pre- and post-contrast minus pre-contrast scores.|Mean Difference (Final Values)|1.27|||||TWO_SIDED|95.0|1.11|1.43|||||Descriptive comparison of the result following gadobutrol with the result following gadoquatrane.|Average Reader||1.43|1.11|
72412589|NCT04307186|144333266|OTHER|95% two-sided CIs based on a t-distribution for the difference of combined pre- and post-contrast minus pre-contrast scores.|Mean Difference (Final Values)|1.19|||||TWO_SIDED|95.0|1.05|1.32|||||Descriptive comparison of the result following gadobutrol with the result following gadoquatrane.|Average Reader||1.32|1.05|
72412590|NCT01175226|144333268|SUPERIORITY|||||||0.02|||||||ANCOVA|||||||0.020
72412591|NCT02854540|144333270|OTHER||Mean difference (percent)|59.0|STANDARD_DEVIATION|16.0|||TWO_SIDED|||||||||||||
72412592|NCT00754845|144333273|SUPERIORITY||Hazard Ratio (HR)|0.66||||0.01|TWO_SIDED|95.0|0.48|0.91|||Log Rank|Stratified by the stratification factors at randomization||||0.91|0.48|0.01
72412593|NCT00754845|144333274|SUPERIORITY|||||||0.007|||||||Log Rank|||||||0.007
72412594|NCT00754845|144333275|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.83|TWO_SIDED|95.0|0.73|1.28|||Log Rank|||||1.28|0.73|0.83
72412595|NCT00754845|144333276|SUPERIORITY||||||<|0.01|||||||Mixed Models Analysis|||||||<0.01
72412596|NCT02897141|144333316|SUPERIORITY||Mean Difference (Final Values)|-0.541|STANDARD_ERROR_OF_MEAN|0.156||0.001|TWO_SIDED|||||Model controlled for age, sex, race, education, and CD4 count ; a=0.05|Mixed Models Analysis|||Anxiety||||0.001
72412597|NCT02897141|144333316|SUPERIORITY||Mean Difference (Final Values)|-0.149|STANDARD_ERROR_OF_MEAN|0.161||0.356|TWO_SIDED|||||Model controlled for age, sex, race, education, and CD4 count; a=0.05|Mixed Models Analysis|||Cough or Shortness of Breath||||0.356
72412598|NCT02897141|144333316|SUPERIORITY||Mean Difference (Final Values)|-0.533|STANDARD_ERROR_OF_MEAN|0.163||0.001|TWO_SIDED|||||Model controlled for age, sex, race, education, and CD4 count ; a=0.05|Mixed Models Analysis|||Depression||||0.001
72412599|NCT02897141|144333316|SUPERIORITY||Mean Difference (Final Values)|-0.007|STANDARD_ERROR_OF_MEAN|0.141||0.962|TWO_SIDED|||||Model controlled for age, sex, race, education, and CD4 count ; a=0.05|Mixed Models Analysis|||Diarrhea||||0.962
72412600|NCT02897141|144333316|SUPERIORITY||Mean Difference (Final Values)|-0.073|STANDARD_ERROR_OF_MEAN|0.162||0.651|TWO_SIDED|||||Model controlled for age, sex, race, education, and CD4 count ; a=0.05|Mixed Models Analysis|||Difficulty falling or staying asleep||||0.651
72412601|NCT02897141|144333316|SUPERIORITY|Model controlled for age, sex, race, education, and CD4 count ; a=0.05|Mean Difference (Final Values)|-0.174|STANDARD_ERROR_OF_MEAN|0.145||0.23|TWO_SIDED||||||Mixed Models Analysis|||Difficulty remembering||||0.230
72412602|NCT02897141|144333316|SUPERIORITY||Mean Difference (Final Values)|-0.138|STANDARD_ERROR_OF_MEAN|0.126||0.275|TWO_SIDED|||||Model controlled for age, sex, race, education, and CD4 count ; a=0.05|Mixed Models Analysis|||Dizziness||||0.275
72412603|NCT02897141|144333316|SUPERIORITY||Mean Difference (Final Values)|-0.003|STANDARD_ERROR_OF_MEAN|0.175||0.987|TWO_SIDED|||||Model controlled for age, sex, race, education, and CD4 count ; a=0.05|Mixed Models Analysis|||Fatigue||||0.987
72548814|NCT03587207|144627198|OTHER|M14459 strain- Between group ratio for comparison of rMenBOMV+ACWY\_S group and rMenBOMV group.|Geometric mean ratio|1.02|||||TWO_SIDED|80.0|0.85|1.22|||ANCOVA|The model is fitted to each serogroup/strain separately.||To investigate possible effects on the immune response based on strains common to rMenBOMV+ACWY\_S versus rMenBOMV study groups, on the Meningitis B M14459(fHbp) strain, one month after last vaccination.||1.22|0.85|
72548815|NCT03587207|144627198|OTHER|96217 strain-Between group ratio for comparison of rMenBOMV+ACWY\_S group and rMenBOMV group.|Geometric mean ratio|0.9|||||TWO_SIDED|80.0|0.75|1.09|||ANCOVA|The model is fitted to each serogroup/strain separately.||To investigate possible effects on the immune response based on strains common to rMenBOMV+ACWY\_S versus rMenBOMV study groups, on the Meningitis B 96217 (NadA) strain, one month after last vaccination.||1.09|0.75|
72548816|NCT03587207|144627198|OTHER|NZ98/254 strain-Between group ratio for comparison of rMenBOMV+ACWY\_S group and rMenBOMV group.|Geometric mean ratio|0.78|||||TWO_SIDED|80.0|0.64|0.96|||ANCOVA|The model is fitted to each serogroup/strain separately.||To investigate possible effects on the immune response based on strains common to rMenBOMV+ACWY\_S versus rMenBOMV study groups, on the Meningitis B NZ98/254 (PorA) strain, one month after last vaccination.||0.96|0.64|
72548817|NCT03587207|144627198|OTHER|M07-0241084 strain-Between group ratio for comparison of rMenBOMV+ACWY\_S group and rMenBOMV group.|Geometric mean ratio|0.71|||||TWO_SIDED|80.0|0.58|0.86|||ANCOVA|The model is fitted to each serogroup/strain separately.||To investigate possible effects on the immune response based on strains common to rMenBOMV+ACWY\_S versus rMenBOMV study groups, on the Meningitis B M07-0241084 (NHBA) strain, one month after last vaccination.||0.86|0.58|
72548818|NCT03587207|144627198|OTHER|Serogroup A- Between group ratio for comparison of rMenBOMV+ACWY\_S group and MenACWY group.|Geometric mean ratio|3.6|||||TWO_SIDED|80.0|2.9|4.47|||ANCOVA|The model is fitted to each serogroup/strain separately.||To investigate possible effects on the immune response based on strains common to rMenBOMV+ACWY\_S versus MenACWY study groups, on the Meningitis serogroup A, one month after last vaccination.||4.47|2.90|
72548819|NCT03587207|144627198|OTHER|Serogroup C- Between group ratio for comparison of rMenBOMV+ACWY\_S group and MenACWY group.|Geometric mean ratio|4.18|||||TWO_SIDED|80.0|3.28|5.31|||ANCOVA|The model is fitted to each serogroup/strain separately.||To investigate possible effects on the immune response based on strains common to rMenBOMV+ACWY\_S versus MenACWY study groups, on the Meningitis serogroup C, one month after last vaccination.||5.31|3.28|
72548820|NCT03587207|144627198|OTHER|Serogroup W- Between group ratio for comparison of rMenBOMV+ACWY\_S group and MenACWY group.|Geometric mean ratio|3.07|||||TWO_SIDED|80.0|2.52|3.73|||ANCOVA|The model is fitted to each serogroup/strain separately.||To investigate possible effects on the immune response based on strains common to rMenBOMV+ACWY\_S versus MenACWY study groups, on the Meningitis serogroup W, one month after last vaccination.||3.73|2.52|
72548821|NCT03587207|144627198|OTHER|Serogroup Y- Between group ratio for comparison of rMenBOMV+ACWY\_S group and MenACWY group.|Geometric mean ratio|2.01|||||TWO_SIDED|80.0|1.53|2.65|||ANCOVA|The model is fitted to each serogroup/strain separately.||To investigate possible effects on the immune response based on strains common to rMenBOMV+ACWY\_S versus MenACWY study groups, on the Meningitis serogroup Y, one month after last vaccination.||2.65|1.53|
72582324|NCT01760304|144695174|SUPERIORITY_OR_OTHER||||||<|0.05|||||||paired t-test|||||||<0.05
72412604|NCT02897141|144333316|SUPERIORITY||Mean Difference (Net)|-0.275|STANDARD_ERROR_OF_MEAN|0.132||0.037|TWO_SIDED|||||Model controlled for age, sex, race, education, and CD4 count ; a=0.05|Mixed Models Analysis|||Fever, chills, sweats||||0.037
72548822|NCT03587207|144627198|OTHER|M14459 strain- Between group ratio for comparison of rMenBOMV+ACWY\_D group and rMenBOMV group.|Geometric mean ratio|1.02|||||TWO_SIDED|80.0|0.85|1.22|||ANCOVA|The model is fitted to each serogroup/strain separately.||To investigate possible effects on the immune response based on strains common to rMenBOMV+ACWY\_D versus rMenBOMV study groups, on the Meningitis B M14459 (fHbp) strain, one month after last vaccination.||1.22|0.85|
72582325|NCT04429503|144695175|NON_INFERIORITY|p-value for one-sided non-inferiority (NI) test at a margin of 4 letters|Least Square (LS) Mean Difference|-0.57|||<|0.0001|TWO_SIDED|95.0|-2.26|1.13|||Mixed Model for Repeated Measurements||HDq12 minus 2q8|||1.13|-2.26|<0.0001
72412605|NCT02897141|144333316|SUPERIORITY||Mean Difference (Final Values)|0.063|STANDARD_ERROR_OF_MEAN|0.101||0.534|TWO_SIDED|||||Model controlled for age, sex, race, education, and CD4 count ; a=0.05|Mixed Models Analysis|||Nausea or vomiting||||0.534
72548823|NCT03587207|144627198|OTHER|96217 strain- Between group ratios for comparison of rMenBOMV+ACWY\_D group and rMenBOMV group|Geometric mean ratio|0.86|||||TWO_SIDED|80.0|0.71|1.04|||ANCOVA|The model is fitted to each serogroup/strain separately.||To investigate possible effects on the immune response based on strains common to rMenBOMV+ACWY\_D versus rMenBOMV study groups, on the Meningitis B 96217 (NadA) strain, one month after last vaccination.||1.04|0.71|
72548824|NCT03587207|144627198|OTHER|NZ98/254 strain-Between group ratio for comparison of rMenBOMV+ACWY\_D group and rMenBOMV group.|Geometric mean ratio|1.01|||||TWO_SIDED|80.0|0.82|1.24|||ANCOVA|The model is fitted to each serogroup/strain separately.||To investigate possible effects on the immune response based on strains common to rMenBOMV+ACWY\_D versus rMenBOMV study groups, on the Meningitis B NZ98/254 (PorA) strain, one month after last vaccination.||1.24|0.82|
72582326|NCT04429503|144695175|NON_INFERIORITY|p-value for one-sided non-inferiority (NI) test at a margin of 4 letters|LS Mean Difference|-1.44||||0.0031|TWO_SIDED|95.0|-3.27|0.39|||Mixed Model for Repeated Measurements||HDq16 minus 2q8|||0.39|-3.27|0.0031
72582327|NCT04429503|144695176|NON_INFERIORITY|The non-inferiority margin was set at 15%|Adjusted Difference (%)|1.98|||||TWO_SIDED|95.0|-6.61|10.57|||||Difference with confidence interval (CI) was calculated using Mantel-Haenszel weighting scheme adjusted for stratification factors|||10.57|-6.61|
72582328|NCT04429503|144695176|NON_INFERIORITY|The non-inferiority margin was set at 15%.|Adjusted Difference (%)|-7.52|||||TWO_SIDED|95.0|-16.88|1.84|||||Difference with confidence interval (CI) was calculated using Mantel-Haenszel weighting scheme adjusted for stratification factors|||1.84|-16.88|
72582329|NCT05516108|144695197|OTHER|||||||0.004|||||||Mixed Models Analysis|Stata mixed||time (pre, post, follow-up) x condition (mindfulness, coping)||||.004
72582330|NCT05516108|144695198|OTHER|||||||0.02|||||||Mixed Models Analysis|||time (pre, post, follow-up) x condition (mindfulness, coping)||||.020
72582331|NCT05516108|144695199|OTHER|||||||0.74|||||||Mixed Models Analysis|Stata melogit||time (pre, post, follow-up) x condition (mindfulness, coping)||||.74
72548825|NCT03587207|144627198|OTHER|M07-0241084 strain-Between group ratio for comparison of rMenBOMV+ACWY\_D group and rMenBOMV group.|Geometric mean ratio|0.89|||||TWO_SIDED|80.0|0.73|1.09|||ANCOVA|The model is fitted to each serogroup/strain separately.||To investigate possible effects on the immune response based on strains common to rMenBOMV+ACWY\_D versus rMenBOMV study groups, on the Meningitis B M07-0241084 (NHBA) strain, one month after last vaccination.||1.09|0.73|
72548826|NCT03587207|144627198|OTHER|Serogroup A-Between group ratio for comparison of rMenBOMV+ACWY\_D group and MenACWY group.|Geometric mean ratio|3.92|||||TWO_SIDED|80.0|3.15|4.88|||ANCOVA|The model is fitted to each serogroup/strain separately.||To investigate possible effects on the immune response based on strains common to rMenBOMV+ACWY\_D versus MenACWY study groups, on the Meningitis serogroup A, one month after last vaccination.||4.88|3.15|
72548827|NCT03587207|144627198|OTHER|Serogroup C- Between group ratio for comparison of rMenBOMV+ACWY\_D group and MenACWY group.|Geometric mean ratio|4.19|||||TWO_SIDED|80.0|3.3|5.34|||ANCOVA|The model is fitted to each serogroup/strain separately.||To investigate possible effects on the immune response based on strains common to rMenBOMV+ACWY\_D versus MenACWY study groups, on the Meningitis serogroup C, one month after last vaccination.||5.34|3.30|
72548828|NCT03587207|144627198|OTHER|Serogroup W- Between group ratio for comparison of rMenBOMV+ACWY\_D group and MenACWY group.|Geometric mean ratio|3.17|||||TWO_SIDED|80.0|2.6|3.87|||ANCOVA|The model is fitted to each serogroup/strain separately.||To investigate possible effects on the immune response based on strains common to rMenBOMV+ACWY\_D versus MenACWY study groups, on the Meningitis serogroup W, one month after last vaccination.||3.87|2.60|
72582332|NCT05516108|144695200|OTHER|||||||0.1|||||||Mixed Models Analysis|||time (pre, post, follow-up) x condition (mindfulness, coping)||||.10
72412606|NCT02897141|144333316|SUPERIORITY||Mean Difference (Final Values)|-0.485|STANDARD_ERROR_OF_MEAN|0.157||0.002|TWO_SIDED|||||Model controlled for age, sex, race, education, and CD4 count ; a=0.05|Mixed Models Analysis|||Neuropathy||||0.002
72548829|NCT03587207|144627198|OTHER|Serogroup Y- Between group ratio for comparison of rMenBOMV+ACWY\_D group and MenACWY group.|Geometric mean ratio|2.22|||||TWO_SIDED|80.0|1.68|2.92|||ANCOVA|The model is fitted to each serogroup/strain separately.||To investigate possible effects on the immune response based on strains common to rMenBOMV+ACWY\_D versus MenACWY study groups, on the Meningitis serogroup Y, one month after last vaccination.||2.92|1.68|
72548830|NCT03587207|144627198|OTHER|M14459- Between group ratios for comparison of MenABCWY group and rMenBOMV group|Geometric mean ratio|1.05|||||TWO_SIDED|80.0|0.87|1.25|||ANCOVA|The model is fitted to each serogroup/strain separately.||To investigate possible effects on the immune response based on strains common to MenABCWY versus rMenBOMV study groups, on the Meningitis B M14459 (fHbp) strain, one month after last vaccination.||1.25|0.87|
72548831|NCT03587207|144627198|OTHER|96217 strain- Between group ratio for comparison of MenABCWY group and rMenBOMV group.|Geometric mean ratio|0.71|||||TWO_SIDED|80.0|0.59|0.86|||ANCOVA|The model is fitted to each serogroup/strain separately.||To investigate possible effects on the immune response based on strains common to MenABCWY versus rMenBOMV study groups, on the Meningitis B 96217 (NadA) strain, one month after last vaccination.||0.86|0.59|
72548832|NCT03587207|144627198|OTHER|NZ98/254 strain-Between group ratios for comparison of MenABCWY group and rMenBOMV group|Geometric mean ratio|0.62|||||TWO_SIDED|80.0|0.5|0.76|||ANCOVA|The model is fitted to each serogroup/strain separately.||To investigate possible effects on the immune response based on strains common to MenABCWY versus rMenBOMV study groups, on the Meningitis B NZ98/254 (PorA) strain, one month after last vaccination.||0.76|0.50|
72548833|NCT03587207|144627198|OTHER|M07-0241084 strain-Between group ratios for comparison of MenABCWY group and rMenBOMV group|Geometric mean ratio|0.52|||||TWO_SIDED|80.0|0.42|0.63|||ANCOVA|The model is fitted to each serogroup/strain separately.||To investigate possible effects on the immune response based on strains common to MenABCWY versus rMenBOMV study groups, on the Meningitis B M07-0241084 (NHBA) strain, one month after last vaccination.||0.63|0.42|
72548834|NCT03587207|144627198|OTHER|Serogroup A- Between group ratios for comparison between MenABCWY group and MenACWY group|Geometric mean ratio|2.02|||||TWO_SIDED|80.0|1.62|2.51|||ANCOVA|The model is fitted to each serogroup/strain separately.||To investigate possible effects on the immune response based on strains common to MenABCWY versus MenACWY study groups, on the Meningitis serogroup A, one month after last vaccination.||2.51|1.62|
72548835|NCT03587207|144627198|OTHER|Serogroup C- Between group ratios for comparison of MenABCWY group and MenACWY group|Odds Ratio (OR)|4.99|||||TWO_SIDED|80.0|3.92|6.35|||ANCOVA|The model is fitted to each serogroup/strain separately.||To investigate possible effects on the immune response based on strains common to MenABCWY versus MenACWY study groups, on the Meningitis serogroup C, one month after last vaccination.||6.35|3.92|
72548836|NCT03587207|144627198|OTHER|Serogroup W- Between group ratios for comparison of MenABCWY group and MenACWY group|Geometric mean ratio|3.25|||||TWO_SIDED|80.0|2.66|3.96|||ANCOVA|The model is fitted to each serogroup/strain separately.||To investigate possible effects on the immune response based on strains common to MenABCWY versus MenACWY study groups, on the Meningitis serogroup W, one month after last vaccination.||3.96|2.66|
72582333|NCT05516108|144695201|OTHER|||||||0.009|||||||Mixed Models Analysis|Stata mixed||time (pre, post, follow-up) x condition (mindfulness, coping)||||.009
72582334|NCT02717507|144695241|OTHER||Slope|0.163|STANDARD_ERROR_OF_MEAN|0.112||0.15|TWO_SIDED|95.0|-0.057|0.383|||Generalized Estimating Equation (GEE)|The treatment effect was determined by testing the significance of the group by time interaction in GEE using a one degree-of-freedom (df) test.|The treatment was considered efficacious if the group by time interaction for LVWT/Dz was statistically significant at a two-sided p\<0.05 and the expected LVWT/Dz was higher for carvedilol than placebo over time.|The null hypothesis is that change in LVWT/Dz across time do not vary by arm. Assuming a type I error=0.05, 2-sided test, 15% attrition/year, and correlation range of 0.6-0.8 between measurements, we projected that a sample size of 125/arm would provide 80% power to detect an effect size of 0.23-0.32 for LVWT/Dz at 24m.||0.383|-0.057|0.15
72582335|NCT02717507|144695242|OTHER||Slope|-3.764|STANDARD_ERROR_OF_MEAN|1.705||0.03|TWO_SIDED|95.0|-7.105|-0.424|||Generalized Estimating Equation (GEE)|The treatment effect was determined by testing the significance of the group by time interaction in GEE using a one degree-of-freedom (df) test.||||-0.424|-7.105|0.03
72582336|NCT02717507|144695243|OTHER||Slope|-0.045|STANDARD_ERROR_OF_MEAN|0.023||0.05|TWO_SIDED|95.0|-0.09|0.001|||Generalized Estimating Equation (GEE)|The treatment effect was determined by testing the significance of the group by time interaction in GEE using a one degree-of-freedom (df) test.||||0.001|-0.09|0.05
72548837|NCT03587207|144627198|OTHER|Serogroup Y- Between group ratio for comparison of MenABCWY group and MenACWY group|Geometric mean ratio|2.38|||||TWO_SIDED|80.0|1.81|3.12|||ANCOVA|The model is fitted to each serogroup/strain separately.||To investigate possible effects on the immune response based on strains common to MenABCWY versus MenACWY study groups, on the Meningitis serogroup Y, one month after last vaccination.||3.12|1.81|
72412607|NCT02897141|144333316|SUPERIORITY||Mean Difference (Final Values)|-0.13|STANDARD_ERROR_OF_MEAN|0.139||0.349|TWO_SIDED|||||Model controlled for age, sex, race, education, and CD4 count ; a=0.05|Mixed Models Analysis|||Skin problems||||0.349
72548838|NCT03587207|144627202|OTHER|Between group ratio is calculated as GMT for rMenBOMV+ACWY\_S Group over GMT for rMenBOMV+ACWY\_D Group. 80% CI are obtained from Analysis of Covariance model fitted to pooled Serogroup B Strains. The following ANCOVA model is used: fixed-effect model including age strata, study group, strain and center as fixed effects. The pre vaccination (Baseline) log-transformed titer with centering at zero is included as a continuous covariate.|Geometric mean ratio|1.02|||||TWO_SIDED|80.0|0.86|1.22|||ANCOVA|An interaction between strain and pre-vaccination log transformed titer is included in the model to fit to the serogroup B test strain data only.||Immune interference due to stress to lymph nodes (lymph-node effect) in rMenBOMV+ACWY\_S versus rMenBOMV+ACWY\_D study groups, on the pooled B strains, one month after first vaccination.||1.22|0.86|
72548839|NCT03587207|144627203|OTHER|M14459 strain- Between group ratio for comparison of rMenBOMV+ACWY\_S group and rMenBOMV+ACWY\_D group.|Geometric mean ratio|1.29|||||TWO_SIDED|80.0|1.02|1.63|||ANCOVA|The model is fitted to each serogroup/strain separately.||Immune interference due to stress to lymph nodes (lymph-node effect) in rMenBOMV+ACWY\_S versus rMenBOMV+ACWY\_D study groups, on the Meningitis B M14459 (fHbp) strain, one month after first vaccination.||1.63|1.02|
72548840|NCT03587207|144627203|OTHER|96217 strain- Between group ratio for comparison of rMenBOMV+ACWY\_S group and rMenBOMV+ACWY\_D group.|Geometric mean ratio|0.93|||||TWO_SIDED|80.0|0.75|1.15|||ANCOVA|The model is fitted to each serogroup/strain separately.||Immune interference due to stress to lymph nodes (lymph-node effect) in rMenBOMV+ACWY\_S versus rMenBOMV+ACWY\_D study groups, on the Meningitis B 96217 (NadA) strain, one month after first vaccination.||1.15|0.75|
72582337|NCT02717507|144695244|OTHER||Slope|-2.194|STANDARD_ERROR_OF_MEAN|1.605||0.17|TWO_SIDED|95.0|-5.34|0.951|||Generalized Estimating Equation (GEE)|The treatment effect was determined by testing the significance of the group by time interaction in GEE using a one degree-of-freedom (df) test.|The treatment was considered efficacious if the group by time interaction for LVESV was statistically significant at a two-sided p\<0.05 and the expected LVESV was lower for carvedilol than placebo over time.|||0.951|-5.34|0.17
72582338|NCT02717507|144695245|OTHER||Slope|0.0|STANDARD_ERROR_OF_MEAN|0.03||0.01|TWO_SIDED|95.0|-141.0|-0.024|||Generalized Estimating Equation (GEE)|The treatment effect was determined by testing the significance of the group by time interaction in GEE using a one degree-of-freedom (df) test.||||-0.024|-0141|0.01
72582339|NCT02717507|144695246|OTHER||Slope|-2.397|STANDARD_ERROR_OF_MEAN|2.603||0.36|TWO_SIDED|95.0|-7.499|2.704|||Generalized Estimating Equation (GEE)|The treatment effect was determined by testing the significance of the group by time interaction in GEE using a one degree-of-freedom (df) test.|The treatment was considered efficacious if the group by time interaction for LVEDV was statistically significant at a two-sided p\<0.05 and the expected LVEDV was lower for carvedilol than placebo over time.|||2.704|-7.499|0.36
72582340|NCT02717507|144695247|OTHER||Slope|0.433|STANDARD_ERROR_OF_MEAN|0.799||0.59|TWO_SIDED|95.0|-1.134|1.999|||Generalized Estimating Equation (GEE)|The treatment effect was determined by testing the significance of the group by time interaction in GEE using a one degree-of-freedom (df) test.||||1.999|-1.134|0.59
72582341|NCT02717507|144695248|OTHER||Slope|-0.06|STANDARD_ERROR_OF_MEAN|0.302||0.84|TWO_SIDED|95.0|-0.652|0.532|||Generalized Estimating Equation (GEE)|The treatment effect was determined by testing the significance of the group by time interaction in GEE using a one degree-of-freedom (df) test.|The treatment can be considered beneficial if the mean difference (treatment - control) slope is positive|||0.532|-0.652|0.84
72582342|NCT02717507|144695249|OTHER||Slope|0.259|STANDARD_ERROR_OF_MEAN|0.373||0.49|TWO_SIDED|95.0|-0.472|0.991|||Generalized Estimating Equation (GEE)|The treatment effect was determined by testing the significance of the group by time interaction in GEE using a one degree-of-freedom (df) test.|The treatment was considered efficacious if the group by time interaction for LVEF was statistically significant at a two-sided p\<0.05 and the expected LVEF was higher for carvedilol than placebo over time.|The null hypothesis is that change in LVEF across time do not vary by arm. Assuming a type I error=0.05, 2-sided test, 15% attrition/year, and correlation range of 1.2-1.6 between measurements, we projected that a sample size of 125/arm would provide 80% power to detect an effect size of 0.23-0.32 for LVEF at 24m.||0.991|-0.472|0.49
72582343|NCT02717507|144695250|OTHER||Slope|0.009|STANDARD_ERROR_OF_MEAN|0.038||0.82|TWO_SIDED|95.0|-0.065|0.082|||Generalized Estimating Equation (GEE)|The treatment effect was determined by testing the significance of the group by time interaction in GEE using a one degree-of-freedom (df) test.||||0.082|-0.065|0.82
72548841|NCT03587207|144627203|OTHER|NZ98/254 strain- Between group ratio for comparison of rMenBOMV+ACWY\_S group and rMenBOMV+ACWY\_D group.|Geometric mean ratio|1.01|||||TWO_SIDED|80.0|0.8|1.29|||ANCOVA|The model is fitted to each serogroup/strain separately.||Immune interference due to stress to lymph nodes (lymph-node effect) in rMenBOMV+ACWY\_S versus rMenBOMV+ACWY\_D study groups, on the Meningitis B NZ98/254 (PorA)strain, one month after first vaccination.||1.29|0.80|
72548842|NCT03587207|144627203|OTHER|M07-0241084 strain-Between group ratio for comparison of rMenBOMV+ACWY\_S group and rMenBOMV+ACWY\_D group.|Odds Ratio (OR)|1.08|||||TWO_SIDED|80.0|0.87|1.36|||ANCOVA|The model is fitted to each serogroup/strain separately.||Immune interference due to stress to lymph nodes (lymph-node effect) in rMenBOMV+ACWY\_S versus rMenBOMV+ACWY\_D study groups, on the Meningitis B M07-0241084 (NHBA) strain, one month after first vaccination.||1.36|0.87|
72582344|NCT02717507|144695251|OTHER||Slope|2.121|STANDARD_ERROR_OF_MEAN|1.79||0.24|TWO_SIDED|95.0|-1.387|5.63|||Generalized Estimating Equation (GEE)|The treatment effect was determined by testing the significance of the group by time interaction in GEE using a one degree-of-freedom (df) test.|The treatment can be considered beneficial if the mean difference (treatment - control) slope is negative|||5.63|-1.387|0.24
72582345|NCT02717507|144695252|OTHER||Slope|5.113|STANDARD_ERROR_OF_MEAN|8.532||0.55|TWO_SIDED|95.0|-11.608|21.835|||Generalized Estimating Equation (GEE)|The treatment effect was determined by testing the significance of the group by time interaction in GEE using a one degree-of-freedom (df) test.|The treatment can be considered beneficial if the mean difference (treatment - control) slope is negative|||21.835|-11.608|0.55
72582346|NCT02717507|144695253|OTHER||Slope|-0.001|STANDARD_ERROR_OF_MEAN|0.001||0.51|TWO_SIDED|95.0|-0.004|0.002|||Generalized Estimating Equation (GEE)|The treatment effect was determined by testing the significance of the group by time interaction in GEE using a one degree-of-freedom (df) test.||||0.002|-0.004|0.51
72582347|NCT02717507|144695254|OTHER||Slope|-0.022|STANDARD_ERROR_OF_MEAN|0.228||0.92|TWO_SIDED|95.0|-0.468|0.424|||Generalized Estimating Equation (GEE)|The treatment effect was determined by testing the significance of the group by time interaction in GEE using a one degree-of-freedom (df) test.||||0.424|-0.468|0.92
72582348|NCT02717507|144695256|OTHER||Slope|0.024|STANDARD_ERROR_OF_MEAN|0.104||0.82|TWO_SIDED|95.0|-0.18|0.229|||Generalized Estimating Equation (GEE)|The treatment effect was determined by testing the significance of the group by time interaction in GEE using a one degree-of-freedom (df) test.|The treatment can be considered beneficial if the mean difference (treatment - control) slope is negative.|||0.229|-0.18|0.82
72548843|NCT03587207|144627203|OTHER|Serogroup A- Between group ratio for comparison of rMenBOMV+ACWY\_S group and rMenBOMV+ACWY\_D group.|Geometric mean ratio|0.77|||||TWO_SIDED|80.0|0.58|1.03|||ANCOVA|The model is fitted to each serogroup/strain separately.||Immune interference due to stress to lymph nodes (lymph-node effect) in rMenBOMV+ACWY\_S versus rMenBOMV+ACWY\_D study groups, on the Meningitis serogroup A, one month after first vaccination.||1.03|0.58|
72582349|NCT02717507|144695257|OTHER||Slope|-0.096|STANDARD_ERROR_OF_MEAN|2.439||0.97|TWO_SIDED|95.0|-4.877|4.685|||Generalized Estimating Equation (GEE)|The treatment effect was determined by testing the significance of the group by time interaction in GEE using a one degree-of-freedom (df) test.||||4.685|-4.877|0.97
72582350|NCT02717507|144695258|OTHER||Slope|1.248|STANDARD_ERROR_OF_MEAN|3.491||0.72|TWO_SIDED|95.0|-5.595|8.091|||Generalized Estimating Equation (GEE)|The treatment effect was determined by testing the significance of the group by time interaction in GEE using a one degree-of-freedom (df) test.|The treatment can be considered beneficial if the mean difference (treatment - control) slope is negative.|The null hypothesis is that change in Average Alanine aminotransferase across time-points described above does not differ by treatment arm, tested using a longitudinal GEE analysis of Average Alanine aminotransferase with a treatment by time interaction.||8.091|-5.595|0.72
72582351|NCT03500198|144695309|SUPERIORITY||||||<|0.0001|||||||t-test, 1 sided|||||||< 0.0001
72582352|NCT03500198|144695311|SUPERIORITY||||||<|0.0001|||||||t-test, 1 sided|||||||<0.0001
72582353|NCT03500198|144695312|SUPERIORITY||||||<|0.0001|||||||1-sided logistic regression|||||||<0.0001
72582354|NCT05921903|144695351|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|GMT Ratio|3.52|||||TWO_SIDED|95.0|2.26|5.48|||ANCOVA||The comparison is done using the group ratio of adjusted GMT (RSV\_HA/Pooled RSV\_IC) (ANCOVA model applied to the log10- transformed titers). The ANCOVA model included the group as fixed effects and the pre-dose log-10 titer as covariate.|To evaluate the humoral immune response to the RSVPreF3 OA investigational vaccine in participants that received lung or kidney solid organ transplant (Pooled RSV\_IC group) and healthy participants (RSV\_HA group) for the RSV-A strain at Visit 2.||5.48|2.26|
72582355|NCT05921903|144695351|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|GMT Ratio|1.62|||||TWO_SIDED|95.0|1.28|2.04|||ANCOVA||The comparison is done using the group ratio of adjusted GMT (RSV\_HA/Pooled RSV\_IC) (ANCOVA model applied to the log10- transformed titers). The ANCOVA model included the group as fixed effects and the pre-dose log-10 titer as covariate.|To evaluate the humoral immune response to the RSVPreF3 OA investigational vaccine in participants that received lung or kidney solid organ transplant (Pooled RSV\_IC group) and healthy participants (RSV\_HA group) for the RSV-A strain at Visit 3.||2.04|1.28|
72582356|NCT05921903|144695352|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|GMT Ratio|1.26|||||TWO_SIDED|95.0|0.94|1.69|||ANCOVA||The comparison is done using the group ratio of adjusted GMT (RSV\_IC\_2/RSV\_IC\_1) (ANCOVA model applied to the log10- transformed titers). ANCOVA model included the group as fixed effect, and SOT type and baseline log10-transformed titer as covariate.|To evaluate the humoral immune response to the RSVPreF3 OA investigational vaccine in participants that received lung or kidney solid organ transplant and 1 dose of vaccine (RSV\_IC\_1 group) and participants that received lung or kidney solid organ transplant and 2 doses of vaccine (RSV\_IC\_2 group) for the RSV-A strain at Visit 4.||1.69|0.94|
72582357|NCT05921903|144695353|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|GMT Ratio|1.31|||||TWO_SIDED|95.0|1.01|1.68|||ANCOVA||The comparison is done using the group ratio of adjusted GMT (RSV\_HA/RSV\_IC\_1) (ANCOVA model applied to the log10- transformed titers). The ANCOVA model included the group as fixed effects and the pre-dose log-10 titer as covariate.|To evaluate the humoral immune response to the RSVPreF3 OA investigational vaccine in participants that received lung or kidney solid organ transplant and 1 dose of study intervention (RSV\_IC\_1 group) and healthy participants (RSV\_HA group) for the RSV-A strain at Visit 4.||1.68|1.01|
72582358|NCT05921903|144695354|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|GMT Ratio|1.02|||||TWO_SIDED|95.0|0.8|1.3|||ANCOVA||The comparison is done using the group ratio of adjusted GMT (RSV\_HA/RSV\_IC\_2) (ANCOVA model applied to the log10- transformed titers). The ANCOVA model included the group as fixed effects and the pre-dose log-10 titer as covariate.|To evaluate the humoral immune response to the RSVPreF3 OA investigational vaccine in participants that received lung or kidney solid organ transplant and 2 doses of study intervention (RSV\_IC\_2 group) and healthy participants (RSV\_HA group) for the RSV-A strain at Visit 4.||1.30|0.80|
72582359|NCT05921903|144695356|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|GMT Ratio|3.37|||||TWO_SIDED|95.0|2.28|4.98|||ANCOVA||The comparison is done using the group ratio of adjusted GMT (RSV\_HA/Pooled RSV\_IC) (ANCOVA model applied to the log10- transformed titers). The ANCOVA model included the group as fixed effects and the pre-dose log-10 titer as covariate.|To evaluate the humoral immune response to the RSVPreF3 OA investigational vaccine in participants that received lung or kidney solid organ transplant (Pooled RSV\_IC group) and healthy participants (RSV\_HA group) for the RSV-B strain at Visit 2.||4.98|2.28|
72582360|NCT05921903|144695356|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|GMT Ratio|1.67|||||TWO_SIDED|95.0|1.32|2.13|||ANCOVA||The comparison is done using the group ratio of adjusted GMT (RSV\_HA/Pooled RSV\_IC) (ANCOVA model applied to the log10- transformed titers). The ANCOVA model included the group as fixed effects and the pre-dose log-10 titer as covariate.|To evaluate the humoral immune response to the RSVPreF3 OA investigational vaccine in participants that received lung or kidney solid organ transplant (Pooled RSV\_IC group) and healthy participants (RSV\_HA group) for the RSV-B strain at Visit 3.||2.13|1.32|
72582361|NCT05921903|144695357|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|GMT Ratio|1.28|||||TWO_SIDED|95.0|0.97|1.7|||ANCOVA||The comparison is done using the group ratio of adjusted GMT (RSV\_IC\_2/RSV\_IC\_1) (ANCOVA model applied to the log10- transformed titers). ANCOVA model included the group as fixed effect, and SOT type and baseline log10-transformed titer as covariate.|To evaluate the humoral immune response to the RSVPreF3 OA investigational vaccine in participants that received lung or kidney solid organ transplant and 1 dose of vaccine (RSV\_IC\_1 group) and participants that received lung or kidney solid organ transplant and 2 doses of vaccine (RSV\_IC\_2 group) for the RSV-B strain at Visit 4.||1.70|0.97|
72582362|NCT05921903|144695358|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|GMT Ratio|1.29|||||TWO_SIDED|95.0|1.0|1.65|||ANCOVA||The comparison is done using the group ratio of adjusted GMT (RSV\_HA/RSV\_IC\_1) (ANCOVA model applied to the log10- transformed titers). The ANCOVA model included the group as fixed effects and the pre-dose log-10 titer as covariate.|To evaluate the humoral immune response to the RSVPreF3 OA investigational vaccine in participants that received lung or kidney solid organ transplant and 1 dose of study intervention (RSV\_IC\_1 group) and healthy participants (RSV\_HA group) for the RSV-B strain at Visit 4.||1.65|1.00|
72582363|NCT05921903|144695359|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|GMT Ratio|1.01|||||TWO_SIDED|95.0|0.8|1.26|||ANCOVA||The comparison is done using the group ratio of adjusted GMT (RSV\_HA/RSV\_IC\_2) (ANCOVA model applied to the log10- transformed titers). The ANCOVA model included the group as fixed effects and the pre-dose log-10 titer as covariate.|To evaluate the humoral immune response to the RSVPreF3 OA investigational vaccine in participants that received lung or kidney solid organ transplant and 2 doses of study intervention (RSV\_IC\_2 group) and healthy participants (RSV\_HA group) for the RSV-B strain at Visit 4.||1.26|0.80|
72582364|NCT05317312|144695375|SUPERIORITY||Mean Difference (Final Values)|18.7|STANDARD_ERROR_OF_MEAN|12.08||0.123|TWO_SIDED|95.0|-5.2|42.7|||Emax||The estimated difference between 1.25mg bid and placebo is based on the Emax model. The values that appear in the Outcome Measure Data Table are observed values.|||42.7|-5.2|0.123
72548844|NCT03587207|144627203|OTHER|Serogroup C- Between group ratio for comparison of rMenBOMV+ACWY\_S group and rMenBOMV+ACWY\_D Group.|Geometric mean ratio|0.84|||||TWO_SIDED|80.0|0.62|1.13|||ANCOVA|The model is fitted to each serogroup/strain separately.||Immune interference due to stress to lymph nodes (lymph-node effect) in rMenBOMV+ACWY\_S versus rMenBOMV+ACWY\_D study groups, on the Meningitis serogroup C, one month after first vaccination.||1.13|0.62|
72548845|NCT03587207|144627203|OTHER|Serogroup W- Between group ratio for comparison of rMenBOMV+ACWY\_S group and rMenBOMV+ACWY\_D group.|Geometric mean ratio|0.88|||||TWO_SIDED|80.0|0.68|1.13|||ANCOVA|The model is fitted to each serogroup/strain separately.||Immune interference due to stress to lymph nodes (lymph-node effect) in rMenBOMV+ACWY\_S versus rMenBOMV+ACWY\_D study groups, on the Meningitis serogroup W, one month after first vaccination.||1.13|0.68|
72548846|NCT03587207|144627203|OTHER|Serogroup Y- Between group ratio for comparison of rMenBOMV+ACWY\_S group and rMenBOMV+ACWY\_D group.|Geometric mean ratio|0.76|||||TWO_SIDED|80.0|0.54|1.08|||ANCOVA|The model is fitted to each serogroup/strain separately.||Immune interference due to stress to lymph nodes (lymph-node effect) in rMenBOMV+ACWY\_S versus rMenBOMV+ACWY\_D study groups, on the Meningitis serogroup Y, one month after first vaccination.||1.08|0.54|
72548847|NCT03587207|144627203|OTHER|M14459 strain- Between group ratio for comparison of MenABCWY group and rMenBOMV+ACWY\_S group.|Geometric mean ratio|0.87|||||TWO_SIDED|80.0|0.69|1.09|||ANCOVA|The model is fitted to each serogroup/strain separately.||Other unknown interference in MenABCWY versus rMenBOMV+ACWY\_S study groups, on the Meningitis B M14459 (fHbp) strain, one month after first vaccination.||1.09|0.69|
72548848|NCT03587207|144627203|OTHER|96217 strain- Between group ratio for comparison of MenABCWY group and rMenBOMV+ACWY\_S group.|Geometric mean ratio|0.73|||||TWO_SIDED|80.0|0.58|0.9|||ANCOVA|The model is fitted to each serogroup/strain separately.||Other unknown interference in MenABCWY versus rMenBOMV+ACWY\_S study groups, on the Meningitis B 96217 (NadA) strain, one month after first vaccination.||0.90|0.58|
72548849|NCT03587207|144627203|OTHER|NZ98/254 strain- Between group ratio for comparison of MenABCWY group and rMenBOMV+ACWY\_S group.|Geometric mean ratio|0.78|||||TWO_SIDED|80.0|0.61|1.0|||ANCOVA|The model is fitted to each serogroup/strain separately.||Other unknown interference in MenABCWY versus rMenBOMV+ACWY\_S study groups, on the Meningitis B NZ98/254 (PorA) strain, one month after first vaccination.||1.00|0.61|
72548850|NCT03587207|144627203|OTHER|M07-0241084 strain- Between group ratio for comparison of MenABCWY group and rMenBOMV+ACWY\_S group.|Geometric mean ratio|0.86|||||TWO_SIDED|80.0|0.68|1.07|||ANCOVA|The model is fitted to each serogroup/strain separately.||Other unknown interference in MenABCWY versus rMenBOMV+ACWY\_S study groups, on the Meningitis B M07-0241084 (NHBA) strain, one month after first vaccination.||1.07|0.68|
72548851|NCT03587207|144627203|OTHER|Serogroup A- Between group ratio for comparison of MenABCWY group and rMenBOMV+ACWY\_S group.|Geometric mean ratio|0.46|||||TWO_SIDED|80.0|0.35|0.62|||ANCOVA|The model is fitted to each serogroup/strain separately.||Other unknown interference in MenABCWY versus rMenBOMV+ACWY\_S study groups, on the Meningitis serogroup A, one month after first vaccination.||0.62|0.35|
72548852|NCT03587207|144627203|OTHER|Serogroup C- Between group ratio for comparison of MenABCWY group and rMenBOMV+ACWY\_S group.|Geometric mean ratio|1.22|||||TWO_SIDED|80.0|0.91|1.65|||ANCOVA|The model is fitted to each serogroup/strain separately.||Other unknown interference in MenABCWY versus rMenBOMV+ACWY\_S study groups, on the Meningitis serogroup C, one month after first vaccination.||1.65|0.91|
72548853|NCT03587207|144627203|OTHER|Serogroup W- Between group ratio for comparison of MenABCWY group and rMenBOMV+ACWY\_S group.|Geometric mean ratio|1.34|||||TWO_SIDED|80.0|1.04|1.72|||ANCOVA|The model is fitted to each serogroup/strain separately.||Other unknown interference in MenABCWY versus rMenBOMV+ACWY\_S study groups, on the Meningitis serogroup W, one month after first vaccination.||1.72|1.04|
72548854|NCT03587207|144627203|OTHER|Serogroup Y- Between group ratio for comparison of MenABCWY group and rMenBOMV+ACWY\_S group.|Geometric mean ratio|0.98|||||TWO_SIDED|80.0|0.7|1.38|||ANCOVA|The model is fitted to each serogroup/strain separately.||Other unknown interference in MenABCWY versus rMenBOMV+ACWY\_S study groups, on the Meningitis serogroup Y, one month after first vaccination.||1.38|0.70|
72582365|NCT05317312|144695375|SUPERIORITY||Mean Difference (Final Values)|34.7|STANDARD_ERROR_OF_MEAN|10.25|<|0.001|TWO_SIDED|95.0|14.4|55.0|||Emax||||The estimated difference between 5mg bid and placebo is based on the Emax model. The values that appear in the Outcome Measure Data Table are observed values.|55.0|14.4|<0.001
72548855|NCT03587207|144627203|OTHER|M14459 strain-Between group ratio for comparison of rMenBOMV\_ACWY\_S group and rMenBOMV group.|Geometric mean ratio|1.05|||||TWO_SIDED|80.0|0.83|1.32|||ANCOVA|The model is fitted to each serogroup/strain separately.||To investigate possible effects on the immune response based on strains common to rMenBOMV+ACWY\_S versus rMenBOMV study groups, on the Meningitis B M14459 (fHbp) strain, one month after first vaccination.||1.32|0.83|
72582366|NCT05317312|144695375|SUPERIORITY||Mean Difference (Final Values)|42.8|STANDARD_ERROR_OF_MEAN|9.53|<|0.001|TWO_SIDED|95.0|23.9|61.7|||Emax||The estimated difference between 15mg bid and placebo is based on the Emax model. The values that appear in the Outcome Measure Data Table are observed values.|||61.7|23.9|<0.001
72548856|NCT03587207|144627203|OTHER|96217 strain-Between group ratio for comparison of rMenBOMV\_ACWY\_S group and rMenBOMV group|Geometric mean ratio|0.8|||||TWO_SIDED|80.0|0.64|1.0|||ANCOVA|The model is fitted to each serogroup/strain separately.||To investigate possible effects on the immune response based on strains common to rMenBOMV+ACWY\_S versus rMenBOMV study groups, on the Meningitis B 96217 (NadA) strain, one month after first vaccination.||1.00|0.64|
72548857|NCT03587207|144627203|OTHER|NZ98/254 strain -Between group ratio for comparison of rMenBOMV\_ACWY\_S group and rMenBOMV group|Geometric mean ratio|0.88|||||TWO_SIDED|80.0|0.69|1.13|||ANCOVA|The model is fitted to each serogroup/strain separately.||To investigate possible effects on the immune response based on strains common to rMenBOMV+ACWY\_S versus rMenBOMV study groups, on the Meningitis B NZ98/254 (PorA) strain, one month after first vaccination.||1.13|0.69|
72412608|NCT02897141|144333316|SUPERIORITY||Mean Difference (Final Values)|-0.25|STANDARD_ERROR_OF_MEAN|0.107||0.02|TWO_SIDED|||||Model controlled for age, sex, race, education, and CD4 count ; a=0.05|Mixed Models Analysis|||Weight loss or wasting||||0.020
72548858|NCT03587207|144627203|OTHER|M07-0241084 strain -Between group ratio for comparison of rMenBOMV\_ACWY\_S group and rMenBOMV group|Geometric mean ratio|0.95|||||TWO_SIDED|80.0|0.76|1.19|||ANCOVA|The model is fitted to each serogroup/strain separately.||To investigate possible effects on the immune response based on strains common to rMenBOMV+ACWY\_S versus rMenBOMV study groups, on the Meningitis B M07-0241084 (NHBA) strain, one month after first vaccination.||1.19|0.76|
72548859|NCT03587207|144627203|OTHER|M14459 strain -Between group ratio for comparison of rMenBOMV\_ACWY\_D group and rMenBOMV group|Geometric mean ratio|0.81|||||TWO_SIDED|80.0|0.64|1.03|||ANCOVA|The model is fitted to each serogroup/strain separately.||To investigate possible effects on the immune response based on strains common to rMenBOMV+ACWY\_D versus rMenBOMV study groups, on the Meningitis B M14459 (fHbp) strain, one month after first vaccination.||1.03|0.64|
72548860|NCT03587207|144627203|OTHER|96217 strain -Between group ratio for comparison of rMenBOMV\_ACWY\_D group and rMenBOMV group|Geometric mean ratio|0.87|||||TWO_SIDED|80.0|0.69|1.09|||ANCOVA|The model is fitted to each serogroup/strain separately.||To investigate possible effects on the immune response based on strains common to rMenBOMV+ACWY\_D versus rMenBOMV study groups, on the Meningitis B 96217 (NadA) strain, one month after first vaccination.||1.09|0.69|
72548861|NCT03587207|144627203|OTHER|NZ98/254 strain -Between group ratio for comparison of rMenBOMV\_ACWY\_D group and rMenBOMV group|Geometrical mean ratio|0.87|||||TWO_SIDED|80.0|0.68|1.12|||ANCOVA|The model is fitted to each serogroup/strain separately.||To investigate possible effects on the immune response based on strains common to rMenBOMV+ACWY\_D versus rMenBOMV study groups, on the Meningitis B NZ98/254 (PorA) strain, one month after first vaccination.||1.12|0.68|
72582367|NCT05317312|144695376|SUPERIORITY||Mean Difference (Final Values)|-0.9|STANDARD_ERROR_OF_MEAN|0.56|||TWO_SIDED|95.0|-2.0|0.2|||||The estimated difference between 1.5mg bid and placebo is based on Mixed Model Repeated Measures.The values in the Outcome Measure Data are observed mean values.|||0.2|-2.0|
72582368|NCT05317312|144695376|SUPERIORITY||Mean Difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|0.56|||TWO_SIDED|95.0|-1.8|0.4|||||The estimated difference between 5mg bid and placebo is based on Mixed Model Repeated Measures. The values in the Outcome Measure Data are observed mean values|||0.4|-1.8|
72548862|NCT03587207|144627203|OTHER|M07-0241084 strain-Between group ratio for comparison of rMenBOMV\_ACWY\_D group and rMenBOMV group|Geometrical mean ratio|0.88|||||TWO_SIDED|80.0|0.7|1.1|||ANCOVA|The model is fitted to each serogroup/strain separately.||To investigate possible effects on the immune response based on strains common to rMenBOMV+ACWY\_D versus rMenBOMV study groups, on the Meningitis B M07-0241084 (NHBA) strain, one month after first vaccination.||1.10|0.70|
72548863|NCT03587207|144627203|OTHER|M14459 strain-Between group ratio for comparison of MenABCWY group and rMenBOMV group|Geometric mean ratio|0.91|||||TWO_SIDED|80.0|0.71|1.15|||ANCOVA|The model is fitted to each serogroup/strain separately.||To investigate possible effects on the immune response based on strains common to MenABCWY versus rMenBOMV study groups, on the Meningitis B M14459 (fHbp)strain, one month after first vaccination.||1.15|0.71|
72582369|NCT05317312|144695376|SUPERIORITY||Mean Difference (Final Values)|-0.8|STANDARD_ERROR_OF_MEAN|0.56|||TWO_SIDED|95.0|-1.9|0.3|||||The estimated difference between 15mg bid and placebo is based on Mixed Model Repeated Measures.. The values in the Outcome Measure Data are observed mean values|||0.3|-1.9|
72582370|NCT05317312|144695377|SUPERIORITY|||||||0.036|||||||Log Rank|||||||0.036
72582371|NCT05317312|144695377|SUPERIORITY|||||||0.006|||||||Log Rank|||||||0.006
72582372|NCT05317312|144695377|SUPERIORITY||||||<|0.001|||||||Log Rank|||||||<0.001
72582373|NCT05317312|144695378|SUPERIORITY|||||||0.411|||||||Log Rank|||||||0.411
72582374|NCT05317312|144695378|SUPERIORITY|||||||0.383|||||||Log Rank|||||||0.383
72582375|NCT05317312|144695378|SUPERIORITY||||||<|0.001|||||||Log Rank|||||||<0.001
72582376|NCT05317312|144695379|SUPERIORITY||Risk Difference (RD)|27.4||||0.042|TWO_SIDED|95.0|2.0|52.7|||Chi-squared|||||52.7|2.0|0.042
72582377|NCT05317312|144695379|SUPERIORITY||Risk Difference (RD)|34.5||||0.01|TWO_SIDED|95.0|9.7|59.3|||Chi-squared|||||59.3|9.7|0.01
72548864|NCT03587207|144627203|OTHER|96217 strain-Between group ratio for comparison of MenABCWY group and rMenBOMV group|Geometric mean ratio|0.58|||||TWO_SIDED|80.0|0.47|0.73|||ANCOVA|The model is fitted to each serogroup/strain separately.||To investigate possible effects on the immune response based on strains common to MenABCWY versus rMenBOMV study groups, on the Meningitis B 96217 (NadA) strain, one month after first vaccination.||0.73|0.47|
72582378|NCT05317312|144695379|SUPERIORITY||Risk Difference (RD)|51.9|||<|0.001|TWO_SIDED|95.0|29.6|74.1|||Chi-squared|||||74.1|29.6|<0.001
72582379|NCT05317312|144695380|SUPERIORITY||Risk Difference (RD)|-31.2||||0.019|TWO_SIDED|95.0|-55.9|-6.5|||Chi-squared|||||-6.5|-55.9|0.019
72582380|NCT05317312|144695380|SUPERIORITY||Risk Difference (RD)|-16.9||||0.187|TWO_SIDED|95.0|-41.6|7.8|||Chi-squared|||||7.8|-41.6|0.187
72582381|NCT05317312|144695380|SUPERIORITY||Risk Difference (RD)|-44.4||||0.001|TWO_SIDED|95.0|-68.3|20.6|||Chi-squared|||||20.6|-68.3|0.001
72582382|NCT02291237|144695381|SUPERIORITY||LS Mean Difference(Eleclazine - Placebo)|-0.55||||0.416|TWO_SIDED|95.0|-1.87|0.78|||ANCOVA|P-value and Least Squares (LS) Means are from model with terms for sex, age (continuous), and treatment group and baseline peak VO2 as the covariate.||The analysis evaluated the change in Peak VO2 from baseline to Week 24 for the eleclazine group compared with that of the placebo group using analysis of covariance (ANCOVA) including terms for baseline Peak VO2, sex, and age (continuous).||0.78|-1.87|0.416
72548865|NCT03587207|144627203|OTHER|NZ98/254 strain-Between group ratio for comparison of MenABCWY group and rMenBOMV group|Geometric mean ratio|0.69|||||TWO_SIDED|80.0|0.54|0.89|||ANCOVA|The model is fitted to each serogroup/strain separately.||To investigate possible effects on the immune response based on strains common to MenABCWY versus rMenBOMV study groups, on the Meningitis B NZ98/254 (PorA) strain, one month after first vaccination.||0.89|0.54|
72412609|NCT02897141|144333317|SUPERIORITY|\[Not specified\]|Mean Difference (Final Values)|-3.06|STANDARD_ERROR_OF_MEAN|7.27||0.001|TWO_SIDED|||||Model controlled for age, sex, race, education, and CD4 count ; a=0.05|Mixed Models Analysis|\[Not specified\]|\[Not specified\]|Physical functioning scale||||0.001
72548866|NCT03587207|144627203|OTHER|M07-0241084 strain-Between group ratio for comparison of MenABCWY group and rMenBOMV group|Geometric mean ratio|0.82|||||TWO_SIDED|80.0|0.65|1.03|||ANCOVA|The model is fitted to each serogroup/strain separately.||To investigate possible effects on the immune response based on strains common to MenABCWY versus rMenBOMV study groups, on the Meningitis B M07-0241084 (NHBA) strain, one month after first vaccination.||1.03|0.65|
72548867|NCT00966953|144627211|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANOVA|||The null hypothesis states that there is no difference between groups.||||0.05
72548868|NCT01734772|144627225|NON_INFERIORITY_OR_EQUIVALENCE|Relative bioavailability|geometric Mean Ratio|149.38|STANDARD_DEVIATION|37.6||0.9456||90.0|124.388|179.383||p-value for ratio outside interval 80% - 125%|ANOVA|Adjustment for effects 'subject' and 'treatment'.|The dispersion value is actually the intraindividual gCV.|||179.383|124.388|0.9456
72548869|NCT01734772|144627225|NON_INFERIORITY_OR_EQUIVALENCE|Relative bioavailability|geometric Mean Ratio|126.47|STANDARD_DEVIATION|33.3||0.5481||90.0|107.363|148.967||p-value for ratio outside interval 80% - 125%|ANOVA|Adjustment for effects 'subject' and 'treatment'.|The dispersion value is actually the intraindividual gCV.|||148.967|107.363|0.5481
72548870|NCT01734772|144627225|NON_INFERIORITY_OR_EQUIVALENCE|Relative bioavailability|geometric Mean Ratio|127.01|STANDARD_DEVIATION|31.6||0.5665||90.0|108.047|149.295||p-value for ratio outside interval 80% - 125%|ANOVA|Adjustment for effects 'subject' and 'treatment'.|The dispersion value is actually the intraindividual gCV.|||149.295|108.047|0.5665
72548871|NCT01734772|144627226|NON_INFERIORITY_OR_EQUIVALENCE|Relative bioavailability|geometric Mean Ratio|164.74|STANDARD_DEVIATION|42.9||0.9841||90.0|133.945|202.619||p-value for ratio outside interval 80% - 125%|ANOVA|Adjustment for effects 'subject' and 'treatment'.|The dispersion value is actually the intraindividual gCV.|||202.619|133.945|0.9841
72548872|NCT01734772|144627226|NON_INFERIORITY_OR_EQUIVALENCE|Relative bioavailability|geometric Mean Ratio|128.61|STANDARD_DEVIATION|39.0||0.6003||90.0|106.37|155.495||p-value for ratio outside interval 80% - 125%|ANOVA|Adjustment for effects 'subject' and 'treatment'.|The dispersion value is actually the intraindividual gCV.|||155.495|106.370|0.6003
72548873|NCT01734772|144627226|NON_INFERIORITY_OR_EQUIVALENCE|Relative bioavailability|gMean Ratio|123.82|STANDARD_DEVIATION|36.9||0.4656||90.0|102.695|149.288||p-value for ratio outside interval 80% - 125%|ANOVA|Adjustment for effects 'subject' and 'treatment'.|The dispersion value is actually the intraindividual gCV.|||149.288|102.695|0.4656
72548874|NCT01600495|144627227|SUPERIORITY_OR_OTHER|||||||0.01||95.0|||||Mixed Models Analysis|||||||0.01
72548875|NCT01600495|144627228|SUPERIORITY_OR_OTHER|||||||0.25||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.25
72548876|NCT01600495|144627230|SUPERIORITY_OR_OTHER||||||<|0.01||95.0|||||Fisher Exact|||Fisher's exact test||||<0.01
72548877|NCT03708211|144627284|OTHER||Ratio of geometric mean|0.9359|||||TWO_SIDED|90.0|0.8084|1.0835||||||Following log-transformation, PK parameters were analyzed by analysis of variance (ANOVA) fitting terms for treatment group, sequence and period. Participants within sequence were treated as a random effect. The obtained point estimates and adjusted 90 percent (%) confidence intervals (CIs) for difference in treatment were exponentially back transformed to provide point and confidence interval estimates for the ratios of interest appropriately.||1.0835|0.8084|
72548878|NCT03708211|144627285|OTHER||Ratio of geometric mean|1.0036|||||TWO_SIDED|90.0|0.8992|1.1201||||||Following log-transformation, PK parameters were analyzed by ANOVA fitting terms for treatment group, sequence and period. Participants within sequence were treated as a random effect. The obtained point estimates and adjusted 90% CIs for difference in treatment were exponentially back transformed to provide point and confidence interval estimates for the ratios of interest appropriately.||1.1201|0.8992|
72548879|NCT03708211|144627286|OTHER||Ratio of geometric mean|1.0071|||||TWO_SIDED|90.0|0.9033|1.1227||||||Following log-transformation, PK parameters were analyzed by ANOVA fitting terms for treatment group, sequence and period. Participants within sequence were treated as a random effect. The obtained point estimates and adjusted 90% CIs for difference in treatment were exponentially back transformed to provide point and confidence interval estimates for the ratios of interest appropriately.||1.1227|0.9033|
72548880|NCT01508936|144627297|SUPERIORITY_OR_OTHER||slope difference|0.3007|STANDARD_ERROR_OF_MEAN|0.2559||0.2407|TWO_SIDED|||||The interaction was tested at the significance level 0.10 using the FAS|Regression, Linear||Active - Placebo|The primary analysis was the linear regression model with model effects including treatment (reslizumab or placebo), blood eosinophil count at baseline, and the interaction of treatment and eosinophil count. A significant treatment by baseline eosinophil interaction would indicate that treatment difference varies by the baseline eosinophil count.||||0.2407
72548881|NCT01508936|144627298|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.076|STANDARD_ERROR_OF_MEAN|0.0417||0.0697|TWO_SIDED|95.0|-0.006|0.158||Statistical significance level is 0.05.|Regression, Linear|treatment, blood eosinophil count at baseline, and the interaction of treatment and eosinophil count as fixed effects.|Active - Placebo|"The change from baseline over the 16 week treatment period was measured for the key secondary variables of:~* Lung function as measured by FEV1~* ACQ~Testing of the key secondary variables was performed using the sequential testing procedure in the order as specified above at the alpha level of 0.05."||0.158|-0.006|0.0697
72412610|NCT02897141|144333317|SUPERIORITY|\[Not specified\]|Median Difference (Final Values)|7.47|STANDARD_ERROR_OF_MEAN|10.02||0.458|TWO_SIDED|||||Model controlled for age, sex, race, education, and CD4 count ; a=0.05|Mixed Models Analysis|\[Not specified\]|\[Not specified\]|Role limitations due to physical health scale||||0.458
72412611|NCT02897141|144333317|SUPERIORITY|\[Not specified\]|Mean Difference (Final Values)|3.5|STANDARD_ERROR_OF_MEAN|9.91||0.725|TWO_SIDED|||||Model controlled for age, sex, race, education, and CD4 count ; a=0.05|Mixed Models Analysis|\[Not specified\]|\[Not specified\]|Role limitations due to emotional problems scale||||0.725
72412612|NCT02897141|144333317|SUPERIORITY|\[Not specified\]|Mean Difference (Final Values)|-1.0|STANDARD_ERROR_OF_MEAN|4.09||0.807|TWO_SIDED|||||Model controlled for age, sex, race, education, and CD4 count ; a=0.05|Mixed Models Analysis|\[Not specified\]|\[Not specified\]|Energy/fatigue scale|\[Not specified\]|||0.807
72412613|NCT02897141|144333317|SUPERIORITY||Mean Difference (Final Values)|1.48|STANDARD_ERROR_OF_MEAN|3.73||0.693|TWO_SIDED|||||Model controlled for age, sex, race, education, and CD4 count ; a=0.05|Mixed Models Analysis|||Emotional well-being scale||||0.693
72412614|NCT02897141|144333317|SUPERIORITY||Mean Difference (Final Values)|-8.93|STANDARD_ERROR_OF_MEAN|5.8||0.128|TWO_SIDED|||||Model controlled for age, sex, race, education, and CD4 count ; a=0.05|Mixed Models Analysis|||Social functioning scale||||0.128
72412615|NCT02897141|144333317|SUPERIORITY||Mean Difference (Final Values)|-14.33|STANDARD_ERROR_OF_MEAN|5.18||0.007|TWO_SIDED|||||Model controlled for age, sex, race, education, and CD4 count ; a=0.05|Mixed Models Analysis|||Pain scale||||0.007
72548882|NCT01508936|144627299|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.123|STANDARD_ERROR_OF_MEAN|0.0762||0.1072|TWO_SIDED|95.0|-0.273|0.027||significance level of 0.05|t-test, 2 sided|Fixed effects for treatment, hx of asthma exacerbation, sex, visit, and interaction of treatment and visit; covariates for height and baseline value|Active - Placebo|"The change from baseline over the 16 week treatment period was measured for the key secondary variables of:~* Lung function as measured by FEV1~* ACQ~Testing of the key secondary variables was performed using the sequential testing procedure in the order as specified above at the alpha level of 0.05."||0.027|-0.273|0.1072
72548883|NCT04603937|144627330|NON_INFERIORITY|The maximum clinically acceptable true difference between KSI-301 and aflibercept participants to be considered non-inferior is 4.5 ETDRS letters, i.e. the non-inferiority margin|Adjusted mean difference|-4.7|STANDARD_ERROR_OF_MEAN|0.97|>|0.9999|TWO_SIDED|95.04|-6.65|-2.81|||Mixed Models Analysis|MMRM model with treatment, visit, treatment by visit interaction, randomization stratification factors, and continuous baseline BCVA and OCT CST.||||-2.81|-6.65|> 0.9999
72548884|NCT04603937|144627331|NON_INFERIORITY|The maximum clinically acceptable non-inferiority margin between KSI-301 and aflibercept subjects is 10% to be considered non-inferior, i.e. the non-inferiority margin is 10%|Difference of weighted percentages|0.6|||<|0.0001|TWO_SIDED|95.04|-0.7|2.0|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haentzel test stratified by study identifier and randomization stratification variables.|Weighted percentages are based on weighted average of observed estimates across strata using CMH weights. The CI are based on the normal approximation to the binomial proportions.|||2|-0.7|<0.0001
72548885|NCT04603937|144627332|NON_INFERIORITY|The maximum clinically acceptable non-inferiority margin between KSI-301 and aflibercept subjects is 10% to be considered non-inferior, i.e the non-inferiority margin is 10%|Difference of weighted percentages|1.2|||<|0.0001|TWO_SIDED|95.04|-1.4|3.9|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haentzel test stratified by randomization stratification variables.|Weighted percentages are based on weighted average of observed estimates across strata using CMH weights. The CI are based on the normal approximation to the binomial proportions.|||3.9|-1.4|<0.0001
72412616|NCT02897141|144333317|SUPERIORITY||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|3.93||0.96|TWO_SIDED|||||Model controlled for age, sex, race, education, and CD4 count ; a=0.05|Mixed Models Analysis|||General health scale||||0.960
72412617|NCT02897141|144333317|SUPERIORITY||Mean Difference (Final Values)|-0.93|STANDARD_ERROR_OF_MEAN|4.47||0.836|TWO_SIDED|||||Model controlled for age, sex, race, education, and CD4 count ; a=0.05|Mixed Models Analysis|||Physical health summary scale||||0.836
72412618|NCT02897141|144333317|SUPERIORITY||Mean Difference (Final Values)|-0.81|STANDARD_ERROR_OF_MEAN|3.6||0.822|TWO_SIDED|||||Model controlled for age, sex, race, education, and CD4 count ; a=0.05|Mixed Models Analysis|||Mental health summary scale||||0.822
72412619|NCT02897141|144333318|SUPERIORITY||Mean Difference (Final Values)|0.79|STANDARD_ERROR_OF_MEAN|1.25||0.529|TWO_SIDED|||||Model controlled for age, sex, race, education, and CD4 count ; a=0.05|Mixed Models Analysis|||Physical Function||||0.529
72412620|NCT02897141|144333318|SUPERIORITY||Mean Difference (Final Values)|1.71|STANDARD_ERROR_OF_MEAN|1.68||0.312|TWO_SIDED|||||Model controlled for age, sex, race, education, and CD4 count ; a=0.05|Mixed Models Analysis|||Anxiety||||0.312
72412621|NCT02897141|144333318|SUPERIORITY||Mean Difference (Final Values)|-0.36|STANDARD_ERROR_OF_MEAN|1.81||0.841|TWO_SIDED|||||Model controlled for age, sex, race, education, and CD4 count ; a=0.05|Mixed Models Analysis|||Depression||||0.841
72412622|NCT02897141|144333318|SUPERIORITY||Mean Difference (Final Values)|0.4|STANDARD_ERROR_OF_MEAN|2.07||0.848|TWO_SIDED|||||Model controlled for age, sex, race, education, and CD4 count ; a=0.05|Mixed Models Analysis|||Fatigue||||0.848
72412623|NCT02897141|144333318|SUPERIORITY||Mean Difference (Final Values)|2.58|STANDARD_ERROR_OF_MEAN|2.03||0.208|TWO_SIDED|||||Model controlled for age, sex, race, education, and CD4 count ; a=0.05|Mixed Models Analysis|||Sleep Disturbance||||0.208
72412624|NCT02897141|144333318|SUPERIORITY||Mean Difference (Final Values)|0.72|STANDARD_ERROR_OF_MEAN|2.29||0.754|TWO_SIDED|||||Model controlled for age, sex, race, education, and CD4 count ; a=0.05|Mixed Models Analysis|||Satisfaction with participation in social roles||||0.754
72412625|NCT02897141|144333318|SUPERIORITY||Mean Difference (Final Values)|1.25|STANDARD_ERROR_OF_MEAN|1.66||0.454|TWO_SIDED|||||Model controlled for age, sex, race, education, and CD4 count ; a=0.05|Mixed Models Analysis|||Pain interference||||0.454
72412626|NCT02897141|144333319|SUPERIORITY||Mean Difference (Final Values)|-2.52|STANDARD_ERROR_OF_MEAN|2.19||0.252|TWO_SIDED|||||Model controlled for age, sex, race, education, and CD4 count ; a=0.05|Mixed Models Analysis|||||||0.252
72412627|NCT02897141|144333320|SUPERIORITY||Mean Difference (Final Values)|-1.51|STANDARD_ERROR_OF_MEAN|0.62||0.017|TWO_SIDED|||||Model controlled for age, sex, race, education, and CD4 count ; a=0.05|Mixed Models Analysis|||CASE adherence index||||0.017
72412628|NCT02897141|144333320|SUPERIORITY||Mean Difference (Final Values)|-4.88|STANDARD_ERROR_OF_MEAN|5.06||0.338|TWO_SIDED|||||Model controlled for age, sex, race, education, and CD4 count ; a=0.05|Mixed Models Analysis|||Visual analogue scale||||0.338
72412629|NCT02897141|144333321|SUPERIORITY||Mean Difference (Final Values)|-0.07|STANDARD_ERROR_OF_MEAN|0.23||0.743|TWO_SIDED|||||Model controlled for age, sex, race, education, and CD4 count ; a=0.05|Mixed Models Analysis|||Overall||||0.743
72412630|NCT02897141|144333321|SUPERIORITY||Mean Difference (Final Values)|-0.28|STANDARD_ERROR_OF_MEAN|0.2||0.166|TWO_SIDED|||||Model controlled for age, sex, race, education, and CD4 count ; a=0.05|Mixed Models Analysis|||Quality of life||||0.166
72412631|NCT02897141|144333321|SUPERIORITY||Mean Difference (Final Values)|0.03|STANDARD_ERROR_OF_MEAN|0.26||0.899|TWO_SIDED|||||Model controlled for age, sex, race, education, and CD4 count ; a=0.05|Mixed Models Analysis|||Perceived usefulness||||0.899
72412632|NCT02897141|144333321|SUPERIORITY||Mean Difference (Final Values)|-0.07|STANDARD_ERROR_OF_MEAN|0.26||0.803|TWO_SIDED|||||Model controlled for age, sex, race, education, and CD4 count ; a=0.05|Mixed Models Analysis|||Perceived ease of use||||0.803
72412633|NCT02897141|144333321|SUPERIORITY||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.28||0.48|TWO_SIDED|||||Model controlled for age, sex, race, education, and CD4 count ; a=0.05|Mixed Models Analysis|||User Control||||0.480
72548886|NCT00262600|144627362|NON_INFERIORITY_OR_EQUIVALENCE|Comparisons between treatment groups were performed using a Cox regression analysis with treatment in the model.|Cox Proportional Hazard|0.9|||<|0.0001||95.0|0.74|1.1||p-value for protocol specified margin of 1.46|Regression, Cox|||Non-inferiority comparison of dabigatran 110 mg to warfarin||1.10|0.74|<.0001
72412634|NCT05204134|144333333|SUPERIORITY|||||||0.06|||||||Wilcoxon (Mann-Whitney)|||||||0.06
72412635|NCT05204134|144333334|SUPERIORITY|||||||0.11|||||||Wilcoxon (Mann-Whitney)|||||||0.11
72412636|NCT05204134|144333335|SUPERIORITY|||||||0.04|||||||Wilcoxon (Mann-Whitney)|||||||0.04
72412637|NCT05204134|144333336|SUPERIORITY|||||||0.03|||||||Wilcoxon (Mann-Whitney)|||||||0.03
72412638|NCT05204134|144333337|SUPERIORITY|||||||0.26|||||||Wilcoxon (Mann-Whitney)|||||||0.26
72412639|NCT05204134|144333338|SUPERIORITY|||||||0.005|||||||Wilcoxon (Mann-Whitney)|||||||0.005
72412640|NCT05204134|144333339|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
72412641|NCT05204134|144333340|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
72412642|NCT05204134|144333341|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
72412643|NCT05204134|144333342|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Comparison between 2 week run-in and 13 weeks Control-IQ use with adaptation.||||<0.001
72412644|NCT05204134|144333343|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
72412645|NCT05204134|144333344|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
72412646|NCT05204134|144333345|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
72412647|NCT05204134|144333346|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
72412648|NCT05204134|144333347|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
72412649|NCT05204134|144333348|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
72412650|NCT05204134|144333349|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
72412651|NCT05204134|144333350|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
72412652|NCT05204134|144333351|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
72412653|NCT05204134|144333352|SUPERIORITY|||||||0.17|||||||Wilcoxon (Mann-Whitney)|||||||0.17
72412654|NCT05204134|144333353|SUPERIORITY|||||||0.03|||||||Wilcoxon (Mann-Whitney)|||||||0.03
72412655|NCT05204134|144333354|SUPERIORITY|||||||0.69|||||||Wilcoxon (Mann-Whitney)|||||||0.69
72412656|NCT02120924|144333377|EQUIVALENCE|Bioequivalence was established if the 90% CI for the ratio of Test/Reference means was contained within the interval \[0.80, 1.25\].|Mean Difference (Net)|0.98|||||TWO_SIDED|90.0|0.92|1.05|||||Bioequivalence was established if the 90% CI for the ratio of Test/Reference means was contained within the interval \[0.80, 1.25\].|The primary endpoint was the percent change from baseline to Week 12 in the inflammatory (papules and pustules) lesion counts in PP population.||1.05|0.92|
72412657|NCT02120924|144333378|EQUIVALENCE|A two-sided, continuity-corrected, 90% CI on the Test-to-Reference difference for the proportion of subjects with treatment success on the IGE was constructed.|Mean Difference (Net)|0.044|||||TWO_SIDED|90.0|-0.028|0.116|||||Bioequivalence was established if the 90% CI for the difference was contained within the interval \[-0.20, +0.20\].|||0.116|-0.028|
72412658|NCT01884350|144333379|SUPERIORITY_OR_OTHER||Difference in Percentage|-0.24||||0.8117|TWO_SIDED|95.0|-2.18|1.7||P-value (two-sided) corresponds to the two-sample t-tests for difference in percentage of adherence at Week 24|t-test, 2 sided|||||1.7|-2.18|0.8117
72412659|NCT01884350|144333380|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value is from a paired t-test comparing percent adherence at 12 and 24 Weeks. Only participants with available data at both Study Days 85 and 169 are included.|paired t-test|||Percent adherence at 12 Weeks v. Percent adherence at 24 Weeks||||<0.0001
72412660|NCT01884350|144333380|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value is from a paired t-test comparing percent adherence at 12 and 24 Weeks. Only participants with available data at both Study Days 85 and 169 are included.|paired t-test|||Percent adherence at 12 Weeks v. Percent adherence at 24 Weeks||||<0.0001
72412661|NCT01884350|144333381|NON_INFERIORITY_OR_EQUIVALENCE|F-test p-value is obtained from the one-way ANOVA model||||||0.8707|||||||ANOVA|||||||0.8707
72412662|NCT01884350|144333381|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.9||||0.6399|TWO_SIDED|95.0|-2.88|4.68||P-values are obtained from the Cochran t-test for pairwise comparison between groups (two-sided).|t-test, 2 sided|||||4.68|-2.88|0.6399
72412663|NCT01884350|144333381|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.08||||0.9616|TWO_SIDED|95.0|-3.45|3.29||P-values are obtained from the Cochran t-test for pairwise comparison between groups (two-sided).|t-test, 2 sided|||||3.29|-3.45|0.9616
72548887|NCT00262600|144627362|NON_INFERIORITY_OR_EQUIVALENCE|Comparisons between treatment groups were performed using a Cox regression analysis with treatment in the model.|Cox Proportional Hazard|0.65|||<|0.0001||95.0|0.52|0.81||p-value for protocol specified margin of 1.46|Regression, Cox|||Non-inferiority comparison of dabigatran 150 mg to warfarin||0.81|0.52|<.0001
72548888|NCT00262600|144627363|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.93||||0.2206||95.0|0.83|1.04||p-value is for superiority testing|Regression, Cox|Comparisons between treatment groups were performed using a Cox regression analysis with treatment in the model.||||1.04|0.83|0.2206
72412664|NCT01884350|144333381|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.82||||0.6341|TWO_SIDED|95.0|-2.6|4.24||P-values are obtained from the Cochran t-test for pairwise comparison between groups (two-sided).|t-test, 2 sided|||||4.24|-2.60|0.6341
72412665|NCT01884350|144333382|SUPERIORITY|||||||0.1924||||||\<=2 Drink/Day Average vs None|Wald Chi-square test|||||||0.1924
72412666|NCT01884350|144333382|SUPERIORITY|||||||0.0305||||||\>=3 Drink/Day Average vs None|Wald Chi-square test|||||||0.0305
72412667|NCT01884350|144333382|SUPERIORITY|||||||0.0107||||||Mini-mental state examination score|Wald Chi-square test|||||||0.0107
72412668|NCT01884350|144333382|SUPERIORITY|||||||0.6982||||||Higher managerial, administrative and professional occupations vs UKSOC1|Wald Chi-square test|||||||0.6982
72412669|NCT01884350|144333382|SUPERIORITY|||||||0.7277||||||Higher professional occupations vs UKSOC1|Wald Chi-square test|||||||0.7277
72548889|NCT00262600|144627363|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.83||||0.0015||95.0|0.74|0.93||p-value is for superiority testing|Regression, Cox|Comparisons between treatment groups were performed using a Cox regression analysis with treatment in the model.||||0.93|0.74|0.0015
72548890|NCT00262600|144627364|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.98||||0.7508||95.0|0.87|1.11||p-value is for superiority testing|Regression, Cox|Comparisons between treatment groups were performed using a Cox regression analysis with treatment in the model.||||1.11|0.87|0.7508
72548891|NCT00262600|144627364|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.84||||0.0093||95.0|0.74|0.96||p-value is for superiority testing|Regression, Cox|Comparisons between treatment groups were performed using a Cox regression analysis with treatment in the model.||||0.96|0.74|0.0093
72548892|NCT00262600|144627365|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.8||||0.0026||95.0|0.7|0.93||p-value is for superiority testing|Regression, Cox|Comparisons between treatment groups were performed using Cox regression analysis with treatment in the model.||Analysis is for adjudicated major bleeds||0.93|0.70|0.0026
72548893|NCT00262600|144627365|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.93||||0.3146||95.0|0.81|1.07||p-value is for superiority testing|Regression, Cox|Comparisons between treatment groups were performed using Cox regression analysis with treatment in the model.||Analysis is for adjudicated major bleeds||1.07|0.81|0.3146
72548894|NCT00262600|144627366|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.3|||<|0.0001||95.0|0.19|0.45||p-value is for superiority testing|Regression, Cox|Comparisons between treatment groups were performed using Cox regression analysis with treatment in the model.||Analysis of ICH||0.45|0.19|<0.0001
72548895|NCT00262600|144627366|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.41|||<|0.0001||95.0|0.28|0.6||p-value is for superiority testing|Regression, Cox|Comparisons between treatment groups were performed using Cox regression analysis with treatment in the model.||Analysis of ICH||0.60|0.28|<0.0001
72548896|NCT00067236|144627392|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.0||||0.4239|TWO_SIDED|95.0|||||ANOVA|||Changes from baseline in efficacy parameters at Day 90.||||0.4239
72548897|NCT00721409|144627417|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.488||||0.0004|TWO_SIDED|95.0|0.319|0.748||1-sided p-value from the log-rank test stratified by stratification factors per randomization and Part.|Log Rank|||The primary hypothesis to be tested was H0: λ=1 versus. HA: λ\<1, where λ was the palbociclib plus letrozole:letrozole alone hazard ratio (HR). A HR less than 1 indicates a reduction in hazard rate in favor of Palbociclib + Letrozole. Stratified analysis was presented above.||0.748|0.319|0.0004
72548898|NCT00721409|144627417|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.299|||<|0.0001|TWO_SIDED|95.0|0.156|0.572||1-sided p-value from the log-rank test.|Log Rank|||The primary hypothesis to be tested was H0: λ=1 versus. HA: λ\<1, where λ was the palbociclib plus letrozole:letrozole alone hazard ratio (HR). A HR less than 1 indicates a reduction in hazard rate in favor of Palbociclib + Letrozole. Unstratified analysis was presented above.||0.572|0.156|<0.0001
72548899|NCT00721409|144627417|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.508||||0.0046|TWO_SIDED|95.0|0.303|0.853||1-sided p-value from the log-rank test.|Log Rank|||The primary hypothesis to be tested was H0: λ=1 versus. HA: λ\<1, where λ was the palbociclib plus letrozole:letrozole alone hazard ratio (HR). A HR less than 1 indicates a reduction in hazard rate in favor of Palbociclib + Letrozole. Unstratified analysis was presented above.||0.853|0.303|0.0046
72548900|NCT00721409|144627430|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.897||||0.2812|TWO_SIDED|95.0|0.623|1.294||1-sided p-value from the log-rank test stratified by Part (α = 0.10).|Log Rank|||Stratified analysis was presented above. Hazard ratio was assuming proportional hazards, a hazard ratio less than 1 indicated a reduction in hazard rate in favor of palbociclib + letrozole.||1.294|0.623|0.2812
72548901|NCT00721409|144627430|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.837||||0.2803|TWO_SIDED|95.0|0.458|1.527||1-sided p-value from the unstratified log-rank test (α=0.10).|Log Rank|||Unstratified analysis was presented above.||1.527|0.458|0.2803
72548902|NCT00721409|144627430|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.935||||0.3875|TWO_SIDED|95.0|0.59|1.48||1-sided p-value from the unstratified log-rank test (α=0.10).|Log Rank|||Unstratified analysis was presented above.||1.480|0.590|0.3875
72548903|NCT00721409|144627431|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.5||||0.1347|TWO_SIDED|95.0|0.76|2.97||1-sided p-value is from the stratified exact test (1-sided, α =0.10)|Cochran-Mantel-Haenszel|||Objective Response CI was calculated using the exact Clopper-Pearson method. The stratified analysis presented above was based on CMH test stratified by Part. An Odds Ratio \>1 means better response in favor of palbociclib + letrozole arm.||2.97|0.76|0.1347
72548904|NCT00721409|144627431|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.37||||0.0849|TWO_SIDED|95.0|0.74|7.84||Chi-square test was used (1-sided, α=0.10)|Chi-squared|||Unstratified analysis was presented above. Exact CI was based on Clopper-Pearson method.||7.84|0.74|0.0849
72548905|NCT00721409|144627431|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.14||||0.4515|TWO_SIDED|95.0|0.48|2.76||Chi-square test was used (1-sided, α=0.10)|Chi-squared|||Unstratified analysis was presented above. Exact CI was based on Clopper-Pearson method.||2.76|0.48|0.4515
72548906|NCT00721409|144627432|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.93||||0.0471|TWO_SIDED|95.0|0.91|4.08||1-sided p-value is from the stratified exact test (1-sided, α =0.10)|Cochran-Mantel-Haenszel|||Objective Response CI was calculated using the exact Clopper-Pearson method. The stratified analysis presented above was based on CMH test stratified by Part. An Odds Ratio \>1 means better response in favor of palbociclib + letrozole arm.||4.08|0.91|0.0471
72548907|NCT00721409|144627432|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.34||||0.118|TWO_SIDED|95.0|0.65|8.66||Chi-square test was used (1-sided, α=0.10)|Chi-squared|||Unstratified analysis was presented above. Exact CI was based on Clopper-Pearson method.||8.66|0.65|0.1180
72548908|NCT00721409|144627432|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.72||||0.1631|TWO_SIDED|95.0|0.65|4.54||Chi-square test was used (1-sided, α=0.10)|Chi-squared|||Unstratified analysis was presented above. Exact CI was based on Clopper-Pearson method.||4.54|0.65|0.1631
72548909|NCT00721409|144627434|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|3.18||||0.0009|TWO_SIDED|95.0|1.48|6.98||1-sided p-value is from the stratified exact test (1-sided, α =0.10).|Cochran-Mantel-Haenszel|||CBR CI was calculated using the exact Clopper-Pearson method. The stratified analysis presented above was based on CMH test stratified by Part. An Odds Ratio \>1 means better response in favor of palbociclib + letrozole arm.||6.98|1.48|0.0009
72548910|NCT00721409|144627434|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|4.18||||0.0065|TWO_SIDED|95.0|1.3|13.9||Chi-square test was used (1-sided, α=0.10)|Chi-squared|||Unstratified analysis was presented above. Exact CI was based on Clopper-Pearson method.||13.90|1.30|0.0065
72548911|NCT00721409|144627434|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.55||||0.0442|TWO_SIDED|95.0|0.89|7.7||Chi-square test was used (1-sided, α=0.10)|Chi-squared|||Unstratified analysis was presented above. Exact CI was based on Clopper-Pearson method.||7.70|0.89|0.0442
72548912|NCT00721409|144627435|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.399|||<|0.0001|TWO_SIDED|95.0|0.265|0.601||1-sided p-value is from the stratified log-rank test (α =0.10).|Log Rank|||Kaplan-Meier method was applied for median and 95% CI. Hazard ratio was based on assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of palbociclib + letrozole.||0.601|0.265|<0.0001
72548913|NCT00721409|144627435|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.299|||<|0.0001|TWO_SIDED|95.0|0.156|0.572||1-sided p-value is from unstratified log-rank test (α=0.10).|Log Rank|||Unstratified analysis was presented above. Kaplan-Meier method was applied for median and 95% CI.||0.572|0.156|<0.0001
72412670|NCT01884350|144333382|SUPERIORITY|||||||0.7581||||||Intermediate occupations vs UKSOC1|Wald Chi-square test|||||||0.7581
72548914|NCT00721409|144627435|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.486||||0.003|TWO_SIDED|95.0|0.288|0.822||1-sided p-value is from unstratified log-rank test (α=0.10).|Log Rank|||Unstratified analysis was presented above. Kaplan-Meier method was applied for median and 95% CI.||0.822|0.288|0.0030
72548915|NCT00721409|144627436|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.2||||0.69|TWO_SIDED|95.0|-0.7|1.0||P-values are based on 2-sample t-test.|t-test, 2 sided|||Statistical analysis presented above is for Pain Severity Scale.||1.0|-0.7|0.6900
72548916|NCT00721409|144627436|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.3||||0.7125|TWO_SIDED|95.0|-1.8|1.2||P-values are based on 2-sample t-test.|t-test, 2 sided|||Statistical analysis presented above is for Pain Severity Scale.||1.2|-1.8|0.7125
72548917|NCT00721409|144627436|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.5||||0.4012|TWO_SIDED|95.0|-0.6|1.5||P-values are based on 2-sample t-test.|t-test, 2 sided|||Statistical analysis presented above is for Pain Severity Scale.||1.5|-0.6|0.4012
72548918|NCT00721409|144627437|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.4||||0.3346|TWO_SIDED|95.0|-0.5|1.3||P-values are based on 2-sample t-test.|t-test, 2 sided|||Statistical analysis presented above is for Pain Interference Scale.||1.3|-0.5|0.3346
72548919|NCT00721409|144627437|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.4||||0.563|TWO_SIDED|95.0|-1.0|1.9||P-values are based on 2-sample t-test.|t-test, 2 sided|||Statistical analysis presented above is for Pain Interference Scale.||1.9|-1.0|0.5630
72548920|NCT00721409|144627437|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.5||||0.4427|TWO_SIDED|95.0|-0.7|1.6||P-values are based on 2-sample t-test.|t-test, 2 sided|||Statistical analysis presented above is for Pain Severity Scale.||1.6|-0.7|0.4427
72548921|NCT00442936|144627507|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.26|||<|0.001|TWO_SIDED|95.0|1.4|3.66|||Regression, Logistic||From logistic model adjusting for geographic region, baseline migraine severity, and age. An odds ratio \>1 is in favor of the first treatment group of the corresponding pairwise comparison.|||3.66|1.40|<0.001
72548922|NCT00442936|144627507|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.81|||<|0.001|TWO_SIDED|95.0|2.42|6.0|||Regression, Logistic||From logistic model adjusting for geographic region, baseline migraine severity, and age. An odds ratio \>1 is in favor of the first treatment group of the corresponding pairwise comparison.|||6.00|2.42|<0.001
72412671|NCT01884350|144333382|SUPERIORITY|||||||0.2328||||||Large employers and higher managerial and adm. occupations vs UKSOC1|Wald Chi-square test|||||||0.2328
72548923|NCT00442936|144627508|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.82|||<|0.001|TWO_SIDED|95.0|2.02|3.95|||Regression, Logistic||From logistic model adjusting for geographic region, baseline migraine severity, and age. An odds ratio \>1 is in favor of the first treatment group of the corresponding pairwise comparison.|||3.95|2.02|<0.001
72582383|NCT02291237|144695382|SUPERIORITY||LS Mean Difference(Eleclazine - Placebo)|-0.42||||0.517|TWO_SIDED|95.0|-1.68|0.85||P-value and LS Means are from model with terms for sex, age (continuous), and treatment group and baseline peak VO2 as the covariate.|ANCOVA|||The analysis evaluated the change in Peak VO2 from baseline to Week 12 for the eleclazine group compared with that of the placebo group using ANCOVA including terms for baseline Peak VO2, sex, and age (continuous).||0.85|-1.68|0.517
72548924|NCT00442936|144627508|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.44|||<|0.001|TWO_SIDED|95.0|2.47|4.79|||Regression, Logistic||From logistic model adjusting for geographic region, baseline migraine severity, and age. An odds ratio \>1 is in favor of the first treatment group of the corresponding pairwise comparison.|||4.79|2.47|<0.001
72412672|NCT01884350|144333382|SUPERIORITY|||||||0.7507||||||Lower managerial, administrative and professional occupations vs UKSOC1|Wald Chi-square test|||||||0.7507
72412673|NCT01884350|144333382|SUPERIORITY|||||||0.0091||||||Lower supervisory and technical occupations vs UKSOC1|Wald Chi-square test|||||||0.0091
72412674|NCT01884350|144333382|SUPERIORITY|||||||0.673||||||Never worked and long-term unemployed vs UKSOC1|Wald Chi-square test|||||||0.6730
72412675|NCT01884350|144333382|SUPERIORITY|||||||0.0117||||||Routine occupations vs UKSOC1|Wald Chi-square test|||||||0.0117
72412676|NCT01884350|144333382|SUPERIORITY|||||||0.191||||||Semi-routine occupations vs UKSOC1|Wald Chi-square test|||||||0.1910
72412677|NCT01884350|144333382|SUPERIORITY|||||||0.9559||||||Paroxysmal vs Persistent Atrial Fibrillation|Wald Chi-square test|||||||0.9559
72548925|NCT00442936|144627509|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.14|||<|0.001|TWO_SIDED|95.0|1.54|2.97|||Regression, Logistic||From logistic model adjusting for geographic region, baseline migraine severity, and age. An odds ratio \>1 is in favor of the first treatment group of the corresponding pairwise comparison.|||2.97|1.54|<0.001
72548926|NCT00442936|144627509|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.61|||<|0.001|TWO_SIDED|95.0|1.89|3.61|||Regression, Logistic||From logistic model adjusting for geographic region, baseline migraine severity, and age. An odds ratio \>1 is in favor of the first treatment group of the corresponding pairwise comparison.|||3.61|1.89|<0.001
72582384|NCT02291237|144695383|SUPERIORITY||LS Mean Difference(Eleclazine - Placebo)|1.54||||0.513|TWO_SIDED|95.0|-3.11|6.19|||ANCOVA|P-value and LS Means are from model with terms for sex, age (continuous), and treatment group and baseline score as the covariate.||The analysis evaluated the change in MLHFQ from baseline to Week 24 for the eleclazine group compared with that of the placebo group using ANCOVA including terms for baseline treadmill exercise time, sex, and age (continuous).||6.19|-3.11|0.513
72582385|NCT02291237|144695384|SUPERIORITY||LS Mean Difference(Eleclazine - Placebo)|0.1||||0.964|TWO_SIDED|95.0|-4.36|4.56|||ANCOVA|P-value and LS Means are from model with terms for sex, age (continuous), and treatment group and baseline score as the covariate.||The analysis evaluated the change in MLHFQ from baseline to Week 12 for the eleclazine group compared with that of the placebo group using ANCOVA including terms for baseline treadmill exercise time, sex, and age (continuous).||4.56|-4.36|0.964
72582386|NCT02291237|144695385|SUPERIORITY||LS Mean Difference(Eleclazine - Placebo)|-0.04||||0.944|TWO_SIDED|95.0|-1.18|1.1|||ANCOVA|P-value and LS Means are from model with terms for sex, age (continuous), and treatment group and baseline score as the covariate.||The analysis evaluated the change in treadmill exercise time from baseline to Week 24 for the eleclazine group compared with that of the placebo group using ANCOVA including terms for baseline treadmill exercise time, sex, and age (continuous).||1.10|-1.18|0.944
72582387|NCT02291237|144695386|SUPERIORITY||LS Mean Difference(Eleclazine - Placebo)|0.0||||0.993|TWO_SIDED|95.0|-0.96|0.97|||ANCOVA|P-value and LS Means are from model with terms for sex, age (continuous), and treatment group and baseline score as the covariate.||The analysis evaluated the change in treadmill exercise time from baseline to Week 12 for the eleclazine group compared with that of the placebo group using ANCOVA including terms for baseline treadmill exercise time, sex, and age (continuous).||0.97|-0.96|0.993
72582388|NCT00699998|144695415|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.915||||0.21|TWO_SIDED|95.0|0.793|1.055||Two-sided p-value based on a log-rank test stratified by clopidogrel status at randomization.|Log Rank||HR and two-sided 95% CI derived using Cox proportional hazards model with treatment and clopidogrel status at randomization as fixed effects.|||1.055|0.793|0.210
72582389|NCT00699998|144695415|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.029||||0.731|TWO_SIDED|95.0|0.865|1.225||Two-sided p-value based on a log-rank test stratified by clopidogrel status at randomization.|Log Rank||HR and two-sided 95% CI derived using Cox proportional hazards model with treatment and clopidogrel status at randomization as fixed effects.|||1.225|0.865|0.731
72582390|NCT00699998|144695416|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.94||||0.388|TWO_SIDED|95.0|0.812|1.088|||Log Rank|Two-sided p-value based on a log-rank test stratified by clopidogrel status at randomization.|HR and two-sided 95% CI derived using Cox proportional hazards model with treatment and clopidogrel status at randomization as fixed effects.|||1.088|0.812|0.388
72412678|NCT01884350|144333382|SUPERIORITY|||||||0.0264||||||Permanent vs Persistant Atrial Fibrillation|Wald Chi-square test|||||||0.0264
72412679|NCT01884350|144333382|SUPERIORITY|||||||0.1087||||||\<=2 Drink/Day Average vs None|Wald Chi-square test|||||||0.1087
72412680|NCT01884350|144333382|SUPERIORITY|||||||0.0679||||||\>=3 Drink/Day Average vs None|Wald Chi-square test|||||||0.0679
72412681|NCT01884350|144333382|SUPERIORITY|||||||0.2128||||||Paroxysmal vs Persistant Atrial Fibrillation|Wald Chi-square test|||||||0.2128
72582391|NCT00699998|144695416|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.998||||0.99|TWO_SIDED|95.0|0.833|1.195||Two-sided p-value based on a log-rank test stratified by clopidogrel status at randomization.|Log Rank||HR and two-sided 95% CI derived using Cox proportional hazards model with treatment and clopidogrel status at randomization as fixed effects.|||1.195|0.833|0.990
72582392|NCT00699998|144695417|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.941||||0.353|TWO_SIDED|95.0|0.826|1.073||Two-sided p-value based on a log-rank test stratified by clopidogrel status at randomization.|Log Rank||HR and two-sided 95% CI derived using Cox proportional hazards model with treatment and clopidogrel status at randomization as fixed effects.|||1.073|0.826|0.353
72548927|NCT00442936|144627510|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.05|||<|0.001|TWO_SIDED|95.0|1.49|2.82|||Regression, Logistic||From logistic model adjusting for geographic region, baseline migraine severity, and age. An odds ratio \>1 is in favor of the first treatment group of the corresponding pairwise comparison.|||2.82|1.49|<0.001
72582393|NCT00699998|144695417|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.029||||0.719|TWO_SIDED|95.0|0.869|1.218||Two-sided p-value based on a log-rank test stratified by clopidogrel status at randomization.|Log Rank||HR and two-sided 95% CI derived using Cox proportional hazards model with treatment and clopidogrel status at randomization as fixed effects.|||1.218|0.869|0.719
72582394|NCT00699998|144695418|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.928||||0.27|TWO_SIDED|95.0|0.81|1.063||Two-sided p-value based on a log-rank test stratified by clopidogrel status at randomization.|Log Rank||HR and two-sided 95% CI derived using Cox proportional hazards model with treatment and clopidogrel status at randomization as fixed effects.|||1.063|0.810|0.270
72412682|NCT01884350|144333382|SUPERIORITY|||||||0.3739||||||Permanent vs Persistant Atrial Fibrillation|Wald Chi-square test|||||||0.3739
72412683|NCT01884350|144333382|SUPERIORITY|||||||0.843||||||VKA status: Naive vs. Non-Naive|Wald Chi-square test|||||||0.843
72548928|NCT00442936|144627510|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.37|||<|0.001|TWO_SIDED|95.0|1.73|3.25|||Regression, Logistic||From logistic model adjusting for geographic region, baseline migraine severity, and age. An odds ratio \>1 is in favor of the first treatment group of the corresponding pairwise comparison.|||3.25|1.73|<0.001
72548929|NCT00442936|144627511|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.73|||<|0.001|TWO_SIDED|95.0|1.25|2.39|||Regression, Logistic||From logistic model adjusting for geographic region, baseline migraine severity, and age. An odds ratio \>1 is in favor of the first treatment group of the corresponding pairwise comparison.|||2.39|1.25|<0.001
72548930|NCT00442936|144627511|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.55||||0.006|TWO_SIDED|95.0|1.13|2.13|||Regression, Logistic||From logistic model adjusting for geographic region, baseline migraine severity, and age. An odds ratio \>1 is in favor of the first treatment group of the corresponding pairwise comparison.|||2.13|1.13|0.006
72548931|NCT00442936|144627512|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.8||||0.002|TWO_SIDED|95.0|1.47|5.35|||Regression, Logistic||From logistic model adjusting for geographic region, baseline migraine severity, and age. An odds ratio \>1 is in favor of the first treatment group of the corresponding pairwise comparison.|||5.35|1.47|0.002
72548932|NCT00442936|144627512|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.75|||<|0.001|TWO_SIDED|95.0|3.15|10.51|||Regression, Logistic||From logistic model adjusting for geographic region, baseline migraine severity, and age. An odds ratio \>1 is in favor of the first treatment group of the corresponding pairwise comparison.|||10.51|3.15|<0.001
72548933|NCT00442936|144627513|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.78||||0.026|TWO_SIDED|95.0|1.07|2.97|||Regression, Logistic||From logistic model adjusting for geographic region, baseline migraine severity, and age. An odds ratio \>1 is in favor of the first treatment group of the corresponding pairwise comparison.|||2.97|1.07|0.026
72548934|NCT00442936|144627513|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.34|||<|0.001|TWO_SIDED|95.0|2.08|5.35|||Regression, Logistic||From logistic model adjusting for geographic region, baseline migraine severity, and age. An odds ratio \>1 is in favor of the first treatment group of the corresponding pairwise comparison.|||5.35|2.08|<0.001
72548935|NCT00442936|144627514|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.25||||0.021|TWO_SIDED|95.0|1.13|4.47|||Regression, Logistic||From logistic model adjusting for geographic region, baseline migraine severity, and age. An odds ratio \>1 is in favor of the first treatment group of the corresponding pairwise comparison.|||4.47|1.13|0.021
72548936|NCT00442936|144627514|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.21|||<|0.001|TWO_SIDED|95.0|2.78|9.76|||Regression, Logistic||From logistic model adjusting for geographic region, baseline migraine severity, and age. An odds ratio \>1 is in favor of the first treatment group of the corresponding pairwise comparison.|||9.76|2.78|<0.001
72548937|NCT00818883|144627532|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.6|||<|0.001|TWO_SIDED|95.0|-8.3|-2.9||Overall type I error rate controlled using stepwise testing procedure. First treatment test done at Week 6. If statistically significant at significance level of 5%, then treatment comparison at Week 10 was performed. Tested at 5% significance level.|ANCOVA|||Analysis of Covariance (ANCOVA) model with treatment group as a fixed effect and baseline value as a covariate was performed using Week 6 data.||-2.9|-8.3|<0.001
72548938|NCT00818883|144627532|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.0|||<|0.001||95.0|-7.5|-2.5||Overall type I error rate controlled using stepwise testing procedure. First treatment test done at Week 6. If statistically significant at significance level of 5%, then treatment comparison at Week 10 was performed. Tested at 5% significance level.|ANCOVA|||ANCOVA model with treatment group as a fixed effect and baseline value as a covariate was performed using Week 10 data.||-2.5|-7.5|<0.001
72548939|NCT00818883|144627533|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.7|||<|0.001|TWO_SIDED|95.0|-5.2|-2.2||Overall type I error rate controlled using stepwise testing procedure. First treatment test done at Week 6. If statistically significant at significance level of 5%, then treatment comparison at Week 10 was performed. Tested at 5% significance level.|ANCOVA|||ANCOVA model with treatment group as a fixed effect and baseline value as a covariate was performed using Week 6 data.||-2.2|-5.2|<0.001
72548940|NCT00818883|144627533|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.7|||<|0.001|TWO_SIDED|95.0|-4.1|-1.3||Overall type I error rate controlled using stepwise testing procedure. First treatment test done at Week 6. If statistically significant at significance level of 5%, then treatment comparison at Week 10 was performed. Tested at 5% significance level.|ANCOVA|||ANCOVA model with treatment group as a fixed effect and baseline value as a covariate was performed using Week 10 data.||-1.3|-4.1|<0.001
72548941|NCT00818883|144627534|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.3|||<|0.001|TWO_SIDED|95.0|-10.5|-4.2||Tested at 5% significance level.|ANCOVA|||ANCOVA model with treatment group as a fixed effect and baseline value as a covariate was performed using Week 6 data.||-4.2|-10.5|<0.001
72548942|NCT00818883|144627534|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.2||||0.001|TWO_SIDED|95.0|-6.8|-1.7||Tested at 5% significance level.|ANCOVA|||ANCOVA model with treatment group as a fixed effect and baseline value as a covariate was performed using Week 10 data.||-1.7|-6.8|0.001
72548943|NCT00818883|144627535|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.3|||<|0.001|TWO_SIDED|95.0|-6.3|-2.3||Tested at 5% significance level.|ANCOVA|||ANCOVA model with treatment group as a fixed effect and baseline value as a covariate was performed using Week 6 data.||-2.3|-6.3|<0.001
72548944|NCT00818883|144627535|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.4||||0.006|TWO_SIDED|95.0|-4.2|-0.7||Tested at 5% significance level.|ANCOVA|||ANCOVA model with treatment group as a fixed effect and baseline value as a covariate was performed using Week 10 data.||-0.7|-4.2|0.006
72548945|NCT00818883|144627536|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.8|||<|0.001|TWO_SIDED|95.0|-8.4|-3.2||Tested at 5% significance level.|ANCOVA|||ANCOVA model with treatment group as a fixed effect and baseline value as a covariate was performed using Week 6 data.||-3.2|-8.4|<0.001
72548946|NCT00818883|144627536|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.2|||<|0.001|TWO_SIDED|95.0|-6.4|-2.0||Tested at 5% significance level.|ANCOVA|||ANCOVA model with treatment group as a fixed effect and baseline value as a covariate was performed using Week 10 data.||-2.0|-6.4|<0.001
72548947|NCT00818883|144627537|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.8|||<|0.001|TWO_SIDED|95.0|-5.5|-2.1||Tested at 5% significance level.|ANCOVA|||ANCOVA model with treatment group as a fixed effect and baseline value as a covariate was performed using Week 6 data.||-2.1|-5.5|<0.001
72548948|NCT00818883|144627537|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.6|||<|0.001|TWO_SIDED|95.0|-4.1|-1.1||Tested at 5% significance level.|ANCOVA|||ANCOVA model with treatment group as a fixed effect and baseline value as a covariate was performed using Week 10 data.||-1.1|-4.1|<0.001
72582395|NCT00699998|144695418|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.017||||0.831|TWO_SIDED|95.0|0.862|1.2||Two-sided p-value based on a log-rank test stratified by clopidogrel status at randomization.|Log Rank||HR and two-sided 95% CI derived using Cox proportional hazards model with treatment and clopidogrel status at randomization as fixed effects.|||1.200|0.862|0.831
72582396|NCT00699998|144695419|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-100.208|||<|0.001|TWO_SIDED|95.0|-107.872|-92.545||p-value is for Day 30 comparison. ANCOVA Model: Measurement = treatment + baseline value + clopidogrel status at randomization.|ANCOVA||Estimated Mean Difference (Final Values) for Day 30 comparison|||-92.545|-107.872|<0.001
72582397|NCT00699998|144695419|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-104.475|||<|0.001|TWO_SIDED|95.0|-115.383|-93.566||p-value is for 12 month comparison. ANCOVA Model: Measurement = treatment + baseline value + clopidogrel status at randomization.|ANCOVA||Estimated Mean Difference (Final Values) for 12 month comparison.|||-93.566|-115.383|<0.001
72548949|NCT00048048|144627552|SUPERIORITY_OR_OTHER||Least square mean|0.979|STANDARD_ERROR_OF_MEAN|0.223|||TWO_SIDED|95.0|0.534|1.425|||||To analyze the appropriateness of the chosen conversion factors, a second regression analysis was carried out. This regression was on the three conversion factor dose groups, using the regression slope estimates of Hb. This was not pre-specified.|All cohorts with dosing frequency 1X/ Week||1.425|0.534|
72548950|NCT00048048|144627552|SUPERIORITY_OR_OTHER||Least square mean|0.851|STANDARD_ERROR_OF_MEAN|0.228|||TWO_SIDED|95.0|0.395|1.307|||||To analyze the appropriateness of the chosen conversion factors, a second regression analysis was carried out. This regression was on the three conversion factor dose groups, using the regression slope estimates of Hb. This was not pre-specified.|All cohorts with dosing frequency 1X/ 2Week||1.307|0.395|
72548951|NCT00048048|144627552|SUPERIORITY_OR_OTHER||Least square mean|0.932|STANDARD_ERROR_OF_MEAN|0.222|||TWO_SIDED|95.0|0.488|1.377|||||To analyze the appropriateness of the chosen conversion factors, a second regression analysis was carried out. This regression was on the three conversion factor dose groups, using the regression slope estimates of Hb. This was not pre-specified.|All cohorts with dosing frequency 1X /3 Week||1.377|0.488|
72548952|NCT02684578|144627559|SUPERIORITY|||||||0.39||||||The threshold for statistical significance was p = 0.05.|Linear mixed-effects regression|||||||0.39
72548953|NCT02684578|144627560|SUPERIORITY|||||||0.97||||||The threshold for statistical significance was p = 0.05.|Linear mixed-effects|||||||0.97
72548954|NCT02684578|144627561|SUPERIORITY|||||||0.12||||||The threshold for statistical significance was p = 0.05.|Linear mixed-effects|||||||0.12
72582398|NCT00699998|144695419|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-48.413|||<|0.001|TWO_SIDED|95.0|-63.718|-33.108||p-value is for 30 day comparison. ANCOVA Model: Measurement = treatment + baseline value + clopidogrel status at randomization.|ANCOVA||Estimated Mean Difference (Final Values) is for the 30 day comparison.|||-33.108|-63.718|<0.001
72582399|NCT00699998|144695419|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-46.264|||<|0.001|TWO_SIDED|95.0|-69.061|-23.468||p-value is for the 12 month comparison. ANCOVA Model: Measurement = treatment + baseline value + clopidogrel status at randomization.|ANCOVA||Estimated Mean Difference (Final Values) is for the 12 month comparison.|||-23.468|-69.061|<0.001
72582400|NCT00699998|144695420|SUPERIORITY_OR_OTHER||Geometric Ratio Estimate|0.982||||0.631|TWO_SIDED|95.0|0.91|1.059||p-value is for the 30 day comparison. ANCOVA Model: Measurement = treatment + baseline value + clopidogrel status at randomization.|ANCOVA||Geometric Ratio Estimate is for the 30 day comparison.|||1.059|0.910|0.631
72582401|NCT00699998|144695420|SUPERIORITY_OR_OTHER||Geometric Ratio Estimate|1.01||||0.844|TWO_SIDED|95.0|0.916|1.113||p-value is for the 6 month comparison. ANCOVA Model: Measurement = treatment + baseline value + clopidogrel status at randomization.|ANCOVA||Geometric Ratio Estimate is for the 6 month comparison.|||1.113|0.916|0.844
72582402|NCT00699998|144695420|SUPERIORITY_OR_OTHER||Geometric Ratio Estimate|1.138||||0.098|TWO_SIDED|95.0|0.977|1.325||p-value is for the 30 day comparison. ANCOVA Model: Measurement = treatment + baseline value + clopidogrel status at randomization.|ANCOVA||Geometric Ratio Estimate is for the 30 day comparison.|||1.325|0.977|0.098
72548955|NCT01901055|144627598|SUPERIORITY||Mean Difference (Net)|-0.32|STANDARD_ERROR_OF_MEAN|0.18||0.017|TWO_SIDED|95.0|-0.68|0.04||F-test statistics for group X time = 4.27|Mixed Models Analysis||Treatment Difference = Active CPAP - Sham CPAP|Statistical analyses were revised from the original protocol for reporting results at 24 week because unable to recruit an adequate sample size at this time point of participants originally on CPAP for 24 weeks and those who were in the original sham-CPAP group who crossed over to CPAP and completed 24 weeks of treatment.||0.04|-0.68|0.017
72548956|NCT01901055|144627599|SUPERIORITY||Mean Difference (Net)|-16.78|STANDARD_ERROR_OF_MEAN|10.99||0.307|TWO_SIDED|95.0|-38.66|5.09||F test statistics for group X time = 1.20|Mixed Models Analysis||Treatment Difference = Active CPAP - Sham CPAP|||5.09|-38.66|0.307
72548957|NCT01901055|144627600|SUPERIORITY||Mean Difference (Net)|-0.25|STANDARD_ERROR_OF_MEAN|0.3||0.732|TWO_SIDED|95.0|-0.85|0.35||F test statistics for group X time = 0.31|Mixed Models Analysis||Treatment Difference = Active CPAP - Sham CPAP|||0.35|-0.85|0.732
72548958|NCT01901055|144627601|SUPERIORITY||Mean Difference (Net)|3.65|STANDARD_ERROR_OF_MEAN|2.65||0.919|TWO_SIDED|95.0|-1.62|8.92||F test statistics for group X time = 0.01|Mixed Models Analysis||Treatment Difference = Active CPAP - Sham CPAP|||8.92|-1.62|0.919
72548959|NCT01901055|144627602|SUPERIORITY||Mean Difference (Net)|-0.11|STANDARD_ERROR_OF_MEAN|0.54||0.125|TWO_SIDED|95.0|-1.18|0.96||F-test statistics for group X time = 2.12|Mixed Models Analysis||Treatment Difference = Active CPAP - Sham CPAP|||0.96|-1.18|0.125
72548960|NCT01901055|144627603|SUPERIORITY||Mean Difference (Net)|87.22|STANDARD_ERROR_OF_MEAN|529.1||0.639|TWO_SIDED|95.0|-936.1|1137.5||F-test statistics for group X time = 0.45|Mixed Models Analysis||Treatment Difference = Active CPAP - Sham CPAP|||1137.50|-936.10|0.639
72548961|NCT01901055|144627604|SUPERIORITY||Mean Difference (Net)|-0.63|STANDARD_ERROR_OF_MEAN|0.49||0.461|TWO_SIDED|95.0|-1.61|0.35||F-test statistics for group X time = 0.78|Mixed Models Analysis||Treatment Difference = Active CPAP - Sham CPAP|||0.35|-1.61|0.461
72548962|NCT01901055|144627605|SUPERIORITY||Mean Difference (Net)|3.04|STANDARD_ERROR_OF_MEAN|3.94||0.776|TWO_SIDED|95.0|-4.78|10.86||F-test statistics for group X time= 0.25|Mixed Models Analysis||Treatment Difference = Active CPAP - Sham CPAP|||10.86|-4.78|0.776
72582403|NCT00699998|144695420|SUPERIORITY_OR_OTHER||Geometric Ratio Estimate|1.066||||0.545|TWO_SIDED|95.0|0.867|1.31||p-value is for the 6 month comparison. ANCOVA Model: Measurement = treatment + baseline value + clopidogrel status at randomization.|ANCOVA||Geometric Ratio Estimate is for the 6 month comparison.|||1.310|0.867|0.545
72582404|NCT00699998|144695421|SUPERIORITY_OR_OTHER||Geometric Ratio Estimate|1.018||||0.727|TWO_SIDED|95.0|0.919|1.129||p-value is for the 30 day comparison. ANCOVA Model: Measurement = treatment + baseline value + clopidogrel status at randomization.|ANCOVA||Geometric Ratio Estimate is for the 30 day comparison.|||1.129|0.919|0.727
72582405|NCT00699998|144695421|SUPERIORITY_OR_OTHER||Geometric Ratio Estimate|1.057||||0.346|TWO_SIDED|95.0|0.942|1.187||p-value is for the 6 month comparison. ANCOVA Model: Measurement = treatment + baseline value + clopidogrel status at randomization.|ANCOVA||Geometric Ratio Estimate is for the 6 month comparison.|||1.187|0.942|0.346
72582406|NCT00699998|144695421|SUPERIORITY_OR_OTHER||Geometric Ratio Estimate|1.096||||0.458|TWO_SIDED|95.0|0.859|1.399||p-value is for the 30 day comparison. ANCOVA Model: Measurement = treatment + baseline value + clopidogrel status at randomization.|ANCOVA||Geometric Ratio Estimate is for the 30 day comparison.|||1.399|0.859|0.458
72582407|NCT00699998|144695421|SUPERIORITY_OR_OTHER||Geometric Ratio Estimate|1.033||||0.802|TWO_SIDED|95.0|0.803|1.329||p-value is for the 6 month comparison. ANCOVA Model: Measurement = treatment + baseline value + clopidogrel status at randomization.|ANCOVA||Geometric Ratio Estimate is for the 6 month comparison.|||1.329|0.803|0.802
72548963|NCT01901055|144627606|SUPERIORITY||Mean Difference (Net)|0.33|STANDARD_ERROR_OF_MEAN|0.79||0.378|TWO_SIDED|95.0|-1.24|1.89||F-test statistics for group X time = 0.98|Mixed Models Analysis||Treatment Difference = Active CPAP - Sham CPAP|||1.89|-1.24|0.378
72548964|NCT01901055|144627607|SUPERIORITY||Mean Difference (Net)|3.18|STANDARD_ERROR_OF_MEAN|7.24||0.213|TWO_SIDED|95.0|-11.19|17.56||F-test statistics for group X time = 1.57|Mixed Models Analysis||Treatment Difference = Active CPAP - Sham CPAP|||17.56|-11.19|0.213
72548965|NCT01901055|144627608|SUPERIORITY||Mean Difference (Net)|0.006|STANDARD_ERROR_OF_MEAN|0.64||0.005|TWO_SIDED|95.0|-1.27|1.28||F-test statistics for group X time = 5.66|Mixed Models Analysis||Treatment Difference = Active CPAP - Sham CPAP|||1.28|-1.27|0.005
72548966|NCT00449150|144627661|SUPERIORITY_OR_OTHER||LS means estimate|-0.198||||0.7424|TWO_SIDED|95.0|-1.38|0.98|||ANOVA|||||0.98|-1.38|0.7424
72548967|NCT00449150|144627661|SUPERIORITY_OR_OTHER||LS means estimate|0.055||||0.926||95.0|-1.1|1.21|||ANOVA|||||1.21|-1.10|0.926
72548968|NCT00449150|144627661|SUPERIORITY_OR_OTHER||LS means estimate|-0.252||||0.6699||95.0|-1.41|0.91|||ANOVA|||||0.91|-1.41|0.6699
72548969|NCT03312257|144627663|OTHER|Repeated measures analyses using mixed linear models in STATA (version 15) were undertaken to model myopia progression (primary outcome) and axial elongation (secondary outcome) to account for the clusters of correlated data due to repeated participant outcome measures.|Mean Difference (Final Values)|0.03||||0.7|TWO_SIDED|95.0|-0.14|0.21|||Repeated measures analyses|||||0.21|-0.14|0.70
72548970|NCT03312257|144627664|OTHER|Repeated measures analyses using mixed linear models in STATA (version 15) were undertaken to model myopia progression (primary outcome) and axial elongation (secondary outcome) to account for the clusters of correlated data due to repeated participant outcome measures.|Mean Difference (Final Values)|-0.08||||0.054|TWO_SIDED|95.0|-0.16|0.002|||Repeated measures analyses|||||0.002|-0.16|0.054
72582408|NCT00699998|144695423|SUPERIORITY_OR_OTHER|||||||0.5||95.0||||p-value is for the comparison of physical limitations at baseline. p-values are from a regression model with treatment group and the respective baseline quality-of-life measure as predictors.|ANCOVA|||||||0.5
72582409|NCT00699998|144695423|SUPERIORITY_OR_OTHER|||||||0.72||95.0||||p-value is for the comparison of angina frequency at baseline. p-values are from a regression model with treatment group and the respective baseline quality-of-life measure as predictors.|ANCOVA|||||||0.72
72582410|NCT00699998|144695423|SUPERIORITY_OR_OTHER|||||||0.63||95.0||||p-value is for the comparison of physical limitations at 24 months. p-values are from a regression model with treatment group and the respective baseline quality-of-life measure as predictors.|ANCOVA|||||||0.63
72582411|NCT00699998|144695423|SUPERIORITY_OR_OTHER|||||||0.53||95.0||||p-value is for the comparison of angina frequency at at 24 months. p-values are from a regression model with treatment group and the respective baseline quality-of-life measure as predictors.|ANCOVA|||||||0.53
72582412|NCT00473590|144695428|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.956||||0.9179|TWO_SIDED|95.0|0.404|2.261|||Log Rank|The strata were number of prior cancer treatments (1, \> 1) and β2-microglobulin level (\< 3.5, ≥ 3.5 mg/L).|The hazard ratios were estimated using Cox regression.|Stratified analysis||2.261|0.404|0.9179
72582413|NCT00473590|144695428|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.836||||0.6665|TWO_SIDED|95.0|0.369|1.893||The tests were exploratory because patients were not randomized to the two arms with respect to response status.|Log Rank||The hazard ratios were estimated using Cox regression.|Unstratified analysis.||1.893|0.369|0.6665
72582414|NCT00473590|144695429|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.633||||0.3134|TWO_SIDED|95.0|0.258|1.552|||Log Rank||The hazard ratios were estimated using Cox regression. The strata were number of prior cancer treatments (1, \> 1) and β2-microglobulin level (\< 3.5, ≥ 3.5 mg/L).|Stratified analysis||1.552|0.258|0.3134
72582415|NCT00473590|144695429|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.608||||0.2634|TWO_SIDED|95.0|0.251|1.468|||Log Rank||The hazard ratios were estimated using Cox regression.|Unstratified analysis||1.468|0.251|0.2634
72582416|NCT00473590|144695430|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.743||||0.2804|TWO_SIDED|95.0|0.432|1.276|||Log Rank|The analysis was stratified for number of prior cancer treatments (1, \> 1) and β2-microglobulin level (\< 3.5, ≥ 3.5 mg/L).|The hazard ratio was estimated using Cox regression. The hazard ratio is relative to BORT + P.|The null hypothesis was that there was no difference between the 2 treatment groups. The alternative hypothesis was that progression-free survival was longer in the BORT + BV group. Stratified Analysis.||1.276|0.432|0.2804
72582417|NCT00473590|144695430|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.713||||0.2009|TWO_SIDED|95.0|0.424|1.2|||Log Rank||Hazard ratio relative to BORT + P was estimated using Cox regression.|Unstratified Analysis.||1.200|0.424|0.2009
72582418|NCT00395161|144695432|SUPERIORITY_OR_OTHER|||||||0.29||95.0|||||Log Rank|Two-sided logrank test was used, stratified by immune compromised status at study entry (a factor also used to stratify the study randomization)||Null hypothesis was equal median time in both arms. Sample size calculated to yield 90% power to detect a significant effect, assuming inverse hazard rate of 1.5 using two-sided logrank test with alpha=0.05. This required recruitment until 263 patients with an event were enrolled (though the study was terminated early for futility by the DSMB).||||0.29
72582419|NCT00395161|144695433|SUPERIORITY_OR_OTHER|||||||0.81||95.0|||||Rate analysis (see comments)|95% CIs were calculated for rates in each arm, and rates compared between arms, via approach of DR Cox, Biometrika (1953), vol 40, pp. 354-60.||Null hypothesis of equal event rates in the two study arms.||||0.81
72582420|NCT00395161|144695434|SUPERIORITY_OR_OTHER|||||||0.09||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.09
72582421|NCT00395161|144695435|SUPERIORITY_OR_OTHER|||||||0.07||95.0|||||Chi-squared|||||||0.07
72582422|NCT00395161|144695436|SUPERIORITY_OR_OTHER|||||||0.16||95.0|||||Chi-squared|||||||0.16
72582423|NCT01891864|144695465|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin for the comparison of GP2015 with Enbrel with respect to PASI 75 response at Week 12 was based on response rates reported in two pivotal placebo controlled trials (Leonardi et al 2003; Papp et al 2005). Based on the observed effect size of 45-46%, an equivalence margin of 18% was chosen so that at least 60% of the treatment effect seen for Enbrel was maintained. A response rate of 49% was assumed for the comparator treatment Enbrel.|Risk Difference (RD)|-2.3|||||TWO_SIDED|95.0|-9.85|5.3||||||PASI 75 response rate (proportion of patients showing at least a 75% improvement in PASI) after the first 12 weeks of treatment (Treatment Period 1) was the primary endpoint to assess equivalence between GP2015 and Enbrel®. Therapeutic equivalence in terms of PASI75 could be concluded if the exact 95% confidence interval for the difference in the PASI75 rates is completely contained within the interval \[-18%; 18%\]. A logistic regression model was to be employed.||5.3|-9.85|
72582424|NCT01891864|144695466|NON_INFERIORITY_OR_EQUIVALENCE|A MMRM (Mixed Model Repeated Method) was performed on the percentage change from baseline in PASI score from baseline to Week 12. Therapeutic equivalence in terms of the % change from baseline in PASI score was to be determined if the 95% CI for the difference between GP2015 and Enbrel was contained within the interval \[-15%; 15%\].|Mean Difference (Final Values)|-0.64|||||TWO_SIDED|95.0|-3.474|2.204||||||||2.204|-3.474|
72582425|NCT01891864|144695466|NON_INFERIORITY_OR_EQUIVALENCE|The mean averaged treatment effect (ATE) of percent change from baseline in PASI score up to week 12 was derived for each patient and analyzed using an ANCOVA approach. Therapeutic equivalence in terms of the % change from baseline in PASI score was to be determined if the 95% CI for the difference between GP2015 and Enbrel was contained within the interval \[-15%; 15%\].|Mean Difference (Final Values)|-0.88|||||TWO_SIDED|95.0|-3.61|1.845||||||||1.845|-3.61|
72582426|NCT02892331|144695475|SUPERIORITY|||||||0.006||||||VO2 testing was not performed for one participant in the HIGH-INT group.|ANCOVA|||Comparison between the CON and the HIGH-INT group||||0.006
72582427|NCT02892331|144695475|SUPERIORITY|||||||0.045||||||VO2 testing was not performed for one participant in the HIGH-INT group.|ANCOVA|||Comparison between the CON and MOD-INT group||||0.045
72582428|NCT02892331|144695475|SUPERIORITY|VO2 testing was not performed for one participant in the HIGH-INT group.||||||0.449|||||||ANCOVA|||Comparison between MOD-INT and High-INT groups||||0.449
72582429|NCT02892331|144695476|SUPERIORITY|||||||0.276|||||||ANCOVA|||Comparison between the CON and High-INT groups||||0.276
72582430|NCT02892331|144695476|SUPERIORITY|||||||0.633|||||||ANCOVA|||Comparison between the CON and MOD-INT groups||||0.633
72582431|NCT02892331|144695476|SUPERIORITY|||||||0.555|||||||ANCOVA|||Comparison between the MOD-INT and HIGH-INT groups||||0.555
72582432|NCT02892331|144695477|SUPERIORITY|||||||0.37|||||||ANCOVA|||Comparison between the CON group and the HIGH-INT group||||0.370
72582433|NCT02892331|144695477|SUPERIORITY|||||||0.383|||||||ANCOVA|||Comparison between the CON and the MOD-INT group||||0.383
72582434|NCT02892331|144695477|SUPERIORITY|||||||0.0972|||||||ANCOVA|||Comparison for the MOD-INT and HIGH-INT groups||||0.0972
72582435|NCT02892331|144695478|SUPERIORITY|||||||0.932|||||||ANCOVA|||Comparison between the CON and the HIGH-INT groups||||0.932
72582436|NCT02892331|144695478|SUPERIORITY|||||||0.307|||||||ANCOVA|||Comparison between the CON and MOD-INT groups||||0.307
72582437|NCT02892331|144695478|SUPERIORITY|||||||0.376|||||||ANCOVA|||Comparison between the MOD-INT and the HIGH-INT groups||||0.376
72582438|NCT02892331|144695479|SUPERIORITY|||||||0.136|||||||ANCOVA|||Comparison between the CON and the HIGH-INT groups||||0.136
72582439|NCT02892331|144695479|SUPERIORITY|||||||0.262|||||||ANCOVA|||Comparison between the CON and the MOD-INT group||||0.262
72582440|NCT02892331|144695479|SUPERIORITY|||||||0.715|||||||ANCOVA|||Comparison between the MOD-INT group and the HIGH-INT groups||||0.715
72548971|NCT02796664|144627676|OTHER|Equality test||||||0.462|||||||Fisher Exact|||The null hypothesis is that there is no relationship between ginseng administration and cerebral ischemic events including ischemic stroke and transient ischemic attack. The number of participants who suffered ischemic stroke and the number of paticipants who suffered transient ischemic attack were analyzed together to test the null hypothesis in two by two table.||||0.462
72548972|NCT02796664|144627677|OTHER|Equality test||||||0.34|||||||Fisher Exact|||The null hypothesis is that there is no relationship between ginseng administration and modified Rankin Scale at follow-up.||||0.34
72548973|NCT02796664|144627678|OTHER|Equality test||||||0.13|||||||Fisher Exact|||The null hypothesis is that there is no relationship between ginseng administration and flow change in steno-occlusive lesion.||||0.13
72548974|NCT02796664|144627678|OTHER|Equality test||||||0.17|||||||Chi-squared|||The null hypothesis is that there is no relationship between ginseng administration and flow change in collateral vessel.||||0.17
72548975|NCT02796664|144627679|OTHER|Equality test||||||0.74|||||||Fisher Exact|||The null hypothesis is that there is no relationship between ginseng administration and periventricular white matter lesions at follow-up.||||0.74
72548976|NCT02796664|144627679|OTHER|Equality test||||||0.95|||||||Fisher Exact|||The null hypothesis is that there is no relationship between ginseng administration and deep white matter lesions at follow-up.||||0.95
72582441|NCT02892331|144695480|SUPERIORITY|||||||0.056|||||||ANCOVA|||Comparison between the CON and High-INT groups||||0.056
72548977|NCT02796664|144627680|OTHER|Equality test||||||0.23|||||||Chi-squared|||The null hypothesis is that there is no relationship between ginseng administration and parenchymal ischemic lesions at follow-up.||||0.23
72548978|NCT02796664|144627681|OTHER|Equality test||||||0.79|||||||Wilcoxon (Mann-Whitney)|||The null hypothesis is that there is no relationship between ginseng administration and drug compliance at follow-up.||||0.79
72548979|NCT04128007|144627710|SUPERIORITY||Odds Ratio (OR)|14.65|||<|0.0001|TWO_SIDED|95.0|6.64|32.32|||Cochran-Mantel-Haenszel|Stratified by country, baseline S-IGA, and baseline B-IGA per randomization with multiple imputation of missing data.|Stratified by country, baseline S-IGA, and baseline B-IGA per randomization with multiple imputation of missing data.|S-IGA Success at Week 8 Odds Ratio||32.32|6.64|<0.0001
72548980|NCT04128007|144627711|SUPERIORITY||Odds Ratio (OR)|8.8|||<|0.0001|TWO_SIDED|95.0|3.65|21.18|||Cochran-Mantel-Haenszel|Stratified by country, baseline S-IGA, and baseline B-IGA per randomization with multiple imputation of missing data.|Stratified by country, baseline S-IGA, and baseline B-IGA per randomization with multiple imputation of missing data.|B-IGA Success at Week 8 Odds Ratio||21.18|3.65|<0.0001
72548981|NCT04128007|144627712|SUPERIORITY||Odds Ratio (OR)|4.06|||<|0.0001|TWO_SIDED|95.0|2.14|7.71|||Cochran-Mantel-Haenszel|Stratified by country, baseline S-IGA, and baseline B-IGA per randomization with multiple imputation of missing data.|Stratified by country, baseline S-IGA, and baseline B-IGA per randomization with multiple imputation of missing data.|SI-NRS Success at Week 2 Odds Ratio||7.71|2.14|<0.0001
72548982|NCT04128007|144627712|SUPERIORITY||Odds Ratio (OR)|5.36|||<|0.0001|TWO_SIDED|95.0|2.93|9.78||Stratified by country, baseline S-IGA, and baseline B-IGA per randomization with multiple imputation of missing data.|Cochran-Mantel-Haenszel||Stratified by country, baseline S-IGA, and baseline B-IGA per randomization with multiple imputation of missing data.|SI-NRS Success at Week 4 Odds Ratio||9.78|2.93|<0.0001
72582442|NCT02892331|144695480|SUPERIORITY|||||||0.349|||||||ANCOVA|||Comparison between the CON and MOD-INT groups||||0.349
72582443|NCT02892331|144695480|SUPERIORITY|||||||0.359|||||||ANCOVA|||Comparison between the MOD-INT and HIGH-INT groups||||0.359
72582444|NCT02892331|144695481|SUPERIORITY|||||||0.224|||||||ANCOVA|||Comparison between the CON and HIGH-INT groups||||0.224
72582445|NCT02892331|144695481|SUPERIORITY|||||||0.199|||||||ANCOVA|||Comparison between the CON and MOD-INT groups||||0.199
72582446|NCT02892331|144695481|SUPERIORITY|||||||0.952|||||||ANCOVA|||Comparison between the MOD-INT and the HIGH-INT groups||||0.952
72548983|NCT04128007|144627712|SUPERIORITY||Odds Ratio (OR)|9.74|||<|0.0001|TWO_SIDED|95.0|5.02|18.89||Stratified by country, baseline S-IGA, and baseline B-IGA per randomization with multiple imputation of missing data.|Cochran-Mantel-Haenszel||Stratified by country, baseline S-IGA, and baseline B-IGA per randomization with multiple imputation of missing data.|SI-NRS Success at Week 8 Odds Ratio||18.89|5.02|<0.0001
72548984|NCT04128007|144627713|SUPERIORITY||Least Squares Mean Difference|-19.6|||<|0.0001|TWO_SIDED|95.0|-27.4|-11.8|||ANCOVA|ANCOVA with country; treatment; and baseline S-IGA, B-IGA, and PSD scores as independent variables with multiple imputation of missing data.|ANCOVA with country; treatment; and baseline S-IGA, B-IGA, and PSD scores as independent variables with multiple imputation of missing data.|Comparison of Week 4 Change from Baseline||-11.8|-27.4|<0.0001
72582447|NCT02892331|144695482|SUPERIORITY|||||||0.783|||||||ANCOVA|||Comparison between the CON and HIGH-INT groups||||0.783
72582448|NCT02892331|144695482|SUPERIORITY|||||||0.098|||||||ANCOVA|||Comparison between the CON and MOD-INT groups||||0.098
72412684|NCT01968434|144333443|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||t-test, 2 sided|||The sample size was calculated to detect a 0.75 point difference between any two treatment groups with a 90% power and p\<0.05. Such sample size was 60 subject which was elevated ot 75 subjects per group to account for drop outs. For comparison of cough evaluation before and after treatment a paired Student t test was used.||||<0.01
72412685|NCT01968434|144333444|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||t-test, 2 sided|||||||<0.01
72548985|NCT04128007|144627713|SUPERIORITY||Least Squares Mean Difference|-27.5|||<|0.0001|TWO_SIDED|95.0|-35.5|-19.5|||ANCOVA|ANCOVA with country; treatment; and baseline S-IGA, B-IGA, and PSD scores as independent variables with multiple imputation of missing data.|ANCOVA with country; treatment; and baseline S-IGA, B-IGA, and PSD scores as independent variables with multiple imputation of missing data.|Comparison of Week 8 Change from Baseline||-19.5|-35.5|<0.0001
72582449|NCT02892331|144695482|SUPERIORITY|||||||0.071|||||||ANCOVA|||Comparison between the MOD and HIGH-INT groups||||0.071
72582450|NCT02892331|144695483|SUPERIORITY|||||||0.94|||||||ANCOVA|||Comparison between the CON and the HIGH-INT groups||||0.940
72582451|NCT02892331|144695483|SUPERIORITY|||||||0.994|||||||ANCOVA|||Comparison between the CON and MOD-INT groups||||0.994
72582452|NCT02892331|144695483|SUPERIORITY|||||||0.94|||||||ANCOVA|||Comparison between the MOD-INT and HIGH-INT groups||||0.940
72582453|NCT02892331|144695484|SUPERIORITY|||||||0.769|||||||ANCOVA|||Comparison of the CON and HIGH-INT groups||||0.769
72582454|NCT02892331|144695484|SUPERIORITY|||||||0.8|||||||ANCOVA|||Comparison of the CON and MOD-INT groups||||0.800
72582455|NCT02892331|144695484|SUPERIORITY|||||||0.769|||||||ANCOVA|||||||0.769
72582456|NCT02892331|144695485|SUPERIORITY|||||||1|||||||ANCOVA|||Comparison between the CON and the MOD groups||||1.000
72582457|NCT02892331|144695485|SUPERIORITY|||||||0.993|||||||ANCOVA|||Comparison of HIGH-INT and CON groups||||0.993
72412686|NCT01968434|144333445|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||t-test, 2 sided|||||||<0.05
72412687|NCT02062502|144333450|NON_INFERIORITY_OR_EQUIVALENCE|The conclusion of non-inferiority (similarity) is based on the lower bound of the 2-sided 95% CI on the risk difference excluding a decrease equal to or more than the prespecified criterion of 10.0 percentage points for Varicella zoster virus.|Risk Difference (RD)|0.0|||<|0.001|TWO_SIDED|95.0|-3.2|3.2|||Miettinen and Nurminen|||||3.2|-3.2|<0.001
72412688|NCT02062502|144333451|NON_INFERIORITY_OR_EQUIVALENCE|The conclusion of non-inferiority (similarity) is based on the lower bound of the 2-sided 95% CI on fold-difference, excluding a decrease of 1.5 fold or more.|Risk Difference (RD)|0.95|||<|0.001|TWO_SIDED|95.0|0.85|1.06|||t-test, 2 sided|||||1.06|0.85|<0.001
72548986|NCT04128007|144627714|SUPERIORITY||Hazard Ratio (HR)|3.94|||<|0.0001|TWO_SIDED|95.0|2.764|5.616||Stratified by country, baseline S-IGA, and baseline B-IGA per randomization.|Log Rank||Stratified by country, baseline S-IGA, and baseline B-IGA per randomization.|Time to PSSI-50 Hazard Ratio||5.616|2.764|<0.0001
72548987|NCT04128007|144627715|SUPERIORITY||Odds Ratio (OR)|9.46|||<|0.0001|TWO_SIDED|95.0|4.81|18.61||Stratified by country, baseline S-IGA, and baseline B-IGA per randomization with multiple imputation of missing data.|Cochran-Mantel-Haenszel||Stratified by country, baseline S-IGA, and baseline B-IGA per randomization with multiple imputation of missing data.|PSSI-75 at Week 8 Odds Ratio||18.61|4.81|<0.0001
72548988|NCT04128007|144627716|SUPERIORITY||Odds Ratio (OR)|34.45|||<|0.0001|TWO_SIDED|95.0|8.49|139.77|||Cochran-Mantel-Haenszel|Stratified by country, baseline S-IGA, and baseline B-IGA per randomization with multiple imputation of missing data.|Stratified by country, baseline S-IGA, and baseline B-IGA per randomization with multiple imputation of missing data.|PSSI-90 at Week 8 Odds Ratio||139.77|8.49|<0.0001
72548989|NCT00950807|144627781|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.128|||<|0.001|TWO_SIDED|95.0|0.06|0.196|||Mixed Models Analysis|||||0.196|0.060|<0.001
72548990|NCT00950807|144627781|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.147|||<|0.001|TWO_SIDED|95.0|0.077|0.216|||Mixed Models Analysis|||||0.216|0.077|<0.001
72548991|NCT00950807|144627781|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.095||||0.006|TWO_SIDED|95.0|0.027|0.162|||Mixed Models Analysis|||||0.162|0.027|0.006
72548992|NCT00950807|144627781|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.14|||<|0.001|TWO_SIDED|95.0|0.074|0.205|||Mixed Models Analysis|||||0.205|0.074|<0.001
72548993|NCT00950807|144627781|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.186|||<|0.001|TWO_SIDED|95.0|0.113|0.259|||Mixed Models Analysis|||||0.259|0.113|<0.001
72548994|NCT00950807|144627781|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.079||||0.03|TWO_SIDED|95.0|0.008|0.151|||Mixed Models Analysis|||||0.151|0.008|0.030
72548995|NCT00950807|144627781|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.134|||<|0.001|TWO_SIDED|95.0|0.064|0.204|||Mixed Models Analysis|||||0.204|0.064|<0.001
72548996|NCT00950807|144627781|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.172|||<|0.001|TWO_SIDED|95.0|0.101|0.242|||Mixed Models Analysis|||||0.242|0.101|<0.001
72548997|NCT00950807|144627781|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.105||||0.003|TWO_SIDED|95.0|0.037|0.173|||Mixed Models Analysis|||||0.173|0.037|0.003
72548998|NCT02129348|144627786|SUPERIORITY||Treatment Effect Difference|0.7||||0.53|TWO_SIDED|95.0|-1.4|2.7||The threshold for statistical significance was p = 0.05.|Mixed Models Analysis|||Lithium will significantly reduce agitation/aggression compared to placebo. In intent-to-treat analyses, linear mixed effect models (MEM) were used to estimate means of change scores (baseline versus 12 weeks) by treatment group, lithium versus placebo, for continuous outcomes. The MEM method was used to incorporate all time-points of assessment and deal with missing data for participants who did not reach the 12-week time-point.||2.7|-1.4|0.53
72548999|NCT02129348|144627787|SUPERIORITY||Treatment Effect Difference|2.11||||0.26|TWO_SIDED|95.0|0.73|6.13||The threshold for statistical significance was p = 0.05.|Chi-squared||Odds ratio and its 95% confidence interval were computed.|Change in both NPI core score (≥30% versus \<30%) and CGI behavior change (1 or 2 versus ≥3) were required for response; these two measures were then analyzed separately. A x² test was used to identify whether there was a change in NPI core scores and CGI scores from baseline to week 12.||6.13|0.73|0.26
72549000|NCT02129348|144627788|SUPERIORITY||Treatment Effect Difference|1.79||||0.25|TWO_SIDED|95.0|0.64|5.04||The threshold of statistical significance was p = 0.05.|Chi-squared|||CGI behavior change scores were categorized into responders versus non-responders (1 or 2 versus ≥3) using the last variable observation for drop-outs. A x² test was used to identify the percentage of participants in each group, lithium versus placebo, that improved from baseline to week 12.||5.04|0.64|0.25
72549001|NCT02129348|144627789|SUPERIORITY||Treatment Effect Difference|2.0||||0.21|TWO_SIDED|95.0|-1.1|5.1||The threshold for statistical significance was p = 0.05.|Mixed Models Analysis|||In intent-to-treat analyses, linear mixed effect models (MEM) were used to estimate means of change scores (baseline versus 12 weeks) by treatment group, lithium versus placebo, for continuous outcomes. The MEM method was used to incorporate all time-points of assessment and deal with missing data for participants who did not reach the 12-week time-point.||5.1|-1.1|0.21
72549002|NCT02129348|144627790|SUPERIORITY||Treatment Effect Difference|-0.1||||0.91|TWO_SIDED|95.0|-2.6|2.4||The threshold for statistical significance was p = 0.05.|Mixed Models Analysis|||In intent-to-treat analyses, linear mixed effect models (MEM) were used to estimate means of change scores (baseline versus 12 weeks) by treatment group, lithium versus placebo, for continuous outcomes. The MEM method was used to incorporate all time-points of assessment and deal with missing data for participants who did not reach the 12-week time-point.||2.4|-2.6|0.91
72582458|NCT02892331|144695485|SUPERIORITY|||||||0.994|||||||ANCOVA|||Comparison between the MOD-INT and the HIGH-INT groups||||0.994
72582459|NCT02892331|144695486|SUPERIORITY|||||||0.821|||||||ANCOVA|||Change in insulin sensitivity (CON vs. HIGH-INT)||||0.821
72582460|NCT02892331|144695486|SUPERIORITY|||||||0.985|||||||ANCOVA|||Change in insulin sensitivity (CON vs. MOD-INT)||||0.985
72582461|NCT02892331|144695486|SUPERIORITY|||||||0.856|||||||ANCOVA|||Change in insulin sensitivity (MOD-INT vs. HIGH-INT)||||0.856
72582462|NCT02892331|144695487|SUPERIORITY|||||||0.093|||||||ANCOVA|||Comparison between the CON and HIGH-INT groups||||0.093
72582463|NCT02892331|144695487|SUPERIORITY|||||||0.033|||||||ANCOVA|||Comparison between the CON and the MOD-INT groups||||0.033
72582464|NCT02892331|144695487|SUPERIORITY|||||||0.602|||||||ANCOVA|||Comparison between the MOD-INT and HIGH-INT groups||||0.602
72582465|NCT02892331|144695488|SUPERIORITY|||||||0.424|||||||ANCOVA|||Change in PGC1A (CON vs. HIGH-INT)||||0.424
72582466|NCT02892331|144695488|SUPERIORITY|||||||0.308|||||||ANCOVA|||Change in PGC1A (CON vs. MOD-INT)||||0.308
72582467|NCT02892331|144695488|SUPERIORITY|||||||0.844|||||||ANCOVA|||Change in PGC1a (MOD-INT vs. HIGH-INT)||||0.844
72582468|NCT02892331|144695488|SUPERIORITY|||||||0.135|||||||ANCOVA|||Change in citrate synthase (CON vs. HIGH-INT)||||0.135
72582469|NCT02892331|144695488|SUPERIORITY|||||||0.8|||||||ANCOVA|||Change in Citrate synthase (CON vs. MOD-INT)||||0.800
72582470|NCT02892331|144695488|SUPERIORITY|||||||0.195|||||||ANCOVA|||Change in citrate synthase||||0.195
72582471|NCT02892331|144695488|SUPERIORITY|||||||0.459|||||||ANCOVA|||Change in complex I||||0.459
72582472|NCT02892331|144695488|SUPERIORITY|||||||0.213|||||||ANCOVA|||Change in complex 1 (CON vs. MOD-INT groups)||||0.213
72582473|NCT02892331|144695488|SUPERIORITY|||||||0.971|||||||ANCOVA|||Change in complex II (MOD-INT vs. HIGH-INT)||||0.971
72582474|NCT02892331|144695488|SUPERIORITY|||||||0.634|||||||ANCOVA|||Change in complex III (CON vs. HIGH-INT)||||0.634
72582475|NCT02892331|144695488|SUPERIORITY|||||||0.919|||||||ANCOVA|||Change in Complex III (CON vs. MOD-INT groups)||||0.919
72582476|NCT02892331|144695488|SUPERIORITY|||||||0.574|||||||ANCOVA|||Change in complex III||||0.574
72582477|NCT02892331|144695488|SUPERIORITY|||||||0.295|||||||ANCOVA|||Change in Complex IV (CON vs. HIGH-INT)||||0.295
72582478|NCT02892331|144695488|SUPERIORITY|||||||0.097|||||||ANCOVA|||Change in complex IV (CON vs. MOD-INT)||||0.097
72582479|NCT02892331|144695488|SUPERIORITY|||||||0.468|||||||ANCOVA|||Change in complex IV||||0.468
72582480|NCT02892331|144695488|SUPERIORITY|||||||0.589|||||||ANCOVA|||Change in complex V||||0.589
72582481|NCT02892331|144695488|SUPERIORITY|||||||0.196|||||||ANCOVA|||Change in complex V (CON vs. MOD-INT)||||0.196
72582482|NCT02892331|144695488|SUPERIORITY|||||||0.436|||||||ANCOVA|||Change in Complex V (MOD-INT vs. HIGH-INT)||||0.436
72582483|NCT02892331|144695489|SUPERIORITY|||||||0.756|||||||ANCOVA|||Comparison of general health subscale (CON vs. HIGH INT)||||0.756
72582484|NCT02892331|144695489|SUPERIORITY|||||||0.115|||||||ANCOVA|||General Health Subscale (CON vs. MOD-INT)||||0.115
72582485|NCT02892331|144695489|SUPERIORITY|||||||0.225|||||||ANCOVA|||General Health Subscale (MOD-INT vs. HIGH-INT)||||0.225
72582486|NCT02892331|144695489|SUPERIORITY|||||||0.758|||||||ANCOVA|||Physical health Sub-scale (CON vs. HIGH-INT)||||0.758
72582487|NCT02892331|144695489|SUPERIORITY|||||||0.759|||||||ANCOVA|||Physical health subscale (CON vs. MOD-INT)||||0.759
72582488|NCT02892331|144695489|SUPERIORITY|||||||0.465|||||||ANCOVA|||Physical Health subscale (MOD-INT vs. HIGH-INT)||||0.465
72582489|NCT02892331|144695489|SUPERIORITY|||||||0.549|||||||ANCOVA|||Role Physical subscale (CON vs. HIGH-INT)||||0.549
72582490|NCT02892331|144695489|SUPERIORITY|||||||0.679|||||||ANCOVA|||Role Physical Subscale (CON vs. MOD-INT)||||0.679
72582491|NCT02892331|144695489|SUPERIORITY|||||||0.334|||||||ANCOVA|||Role Physical Subscale (MOD-INT vs. HIGH-INT)||||0.334
72582492|NCT02892331|144695489|SUPERIORITY|||||||0.273|||||||ANCOVA|||Bodily pain subscale (CON vs. HIGH-INT)||||0.273
72582493|NCT02892331|144695489|SUPERIORITY|||||||0.642|||||||ANCOVA|||Bodily pain subscale (CON vs. MOD-INT)||||0.642
72582494|NCT02892331|144695489|SUPERIORITY|||||||0.52|||||||ANCOVA|||Bodily Pain Subscale (MOD-INT vs. HIGH-INT)||||0.520
72582495|NCT02892331|144695489|SUPERIORITY|||||||0.46|||||||ANCOVA|||Vitality subscale (CON vs. HIGH-INT)||||0.460
72582496|NCT02892331|144695489|SUPERIORITY|||||||0.203|||||||ANCOVA|||Vitality sub-scale (CON vs. MOD-INT group)||||0.203
72582497|NCT02892331|144695489|SUPERIORITY|||||||0.058|||||||ANCOVA|||Vitality subscale (MOD-INT vs. HIGH-INT)||||0.058
72582498|NCT02892331|144695489|SUPERIORITY|||||||0.739|||||||ANCOVA|||Social Function subscale (CON vs. HIGH-INT)||||0.739
72582499|NCT02892331|144695489|SUPERIORITY|||||||0.059|||||||ANCOVA|||Social Function subscale (CON vs. MOD-INT)||||0.059
72549003|NCT02129348|144627791|SUPERIORITY||Treatment Effect Difference|0.1||||0.94|TWO_SIDED|95.0|-1.5|1.4||The threshold for statistical significance was p = 0.05.|Mixed Models Analysis||Effect size (d)= -0.02 (Cohen's D)|In intent-to-treat analyses, linear mixed effect models (MEM) were used to estimate means of change scores (baseline versus 12 weeks) by treatment group, lithium versus placebo, for continuous outcomes. The MEM method was used to incorporate all time-points of assessment and deal with missing data for participants who did not reach the 12-week time-point.||1.4|-1.5|0.94
72582500|NCT02892331|144695489|SUPERIORITY|||||||0.038|||||||ANCOVA|||Social Function sub-scale (HIGH-INT vs. MOD-INT)||||0.0380
72582501|NCT02892331|144695489|SUPERIORITY|||||||0.95|||||||ANCOVA|||Comparison of mental health subscale (CON vs. HIGH-INT)||||0.950
72582502|NCT02892331|144695489|SUPERIORITY|||||||0.096|||||||ANCOVA|||Change in mental health subscale (CON Vs. MOD INT)||||0.096
72582503|NCT02892331|144695489|SUPERIORITY|||||||0.127|||||||ANCOVA|||Change in mental health subscale (MOD-INT vs. HIGH-INT)||||0.127
72582504|NCT02892331|144695489|SUPERIORITY|||||||0.373|||||||ANCOVA|||Change in role emotional subscale (CON vs HIGH-INT)||||0.373
72582505|NCT02892331|144695489|SUPERIORITY|||||||0.63|||||||ANCOVA|||Change in role emotional sub-scale||||0.630
72582506|NCT02892331|144695489|SUPERIORITY|||||||0.034|||||||ANCOVA|||Change in role emotional subscale (MOD vs. HIGH-INT)||||0.034
72582507|NCT02892331|144695489|SUPERIORITY|||||||0.07|||||||ANCOVA|||Change in role emotional subscale (CON vs. MOD-INT)||||0.070
72582508|NCT02892331|144695489|SUPERIORITY|||||||0.945|||||||ANCOVA|||Change in physical health sub-scale (MOD-INT vs. HIGH-INT)||||0.945
72582509|NCT02892331|144695490|SUPERIORITY|||||||0.65|||||||ANCOVA|||Change in the mental health sum scale (CON vs. HIGH-INT)||||0.650
72582510|NCT02892331|144695490|SUPERIORITY|||||||0.034|||||||ANCOVA|||Change in mental health (sum) subscale (MOD-INT vs. HIGH-INT)||||0.034
72582511|NCT02892331|144695490|SUPERIORITY|||||||0.33|||||||ANCOVA|||Change in physical health (sum)||||0.330
72582512|NCT02892331|144695490|SUPERIORITY|||||||0.297|||||||ANCOVA|||Change in physical health (sum) subscale||||0.297
72582513|NCT02892331|144695491|SUPERIORITY|||||||0.109|||||||ANCOVA|||Change in steps (CON vs. HIGH-INT)||||0.109
72582514|NCT02892331|144695491|SUPERIORITY|||||||0.099|||||||ANCOVA|||Change in steps (CON vs. MOD-INT)||||0.099
72582515|NCT02892331|144695491|SUPERIORITY|||||||0.947|||||||ANCOVA|||Change in steps (MOD-INT vs. HIGH-INT)||||0.947
72582516|NCT00610428|144695494|SUPERIORITY|||||||0.084||||||p-values calculated by Log-rank Test in step-down sequence (10 mg to 5 mg)|Survival|||Survival time is defined as time to the first successful headache relief.||||0.0840
72582517|NCT00610428|144695494|SUPERIORITY|Survival time is defined as time to the first successful headache relief.||||||0.0383||||||p-values calculated by Log-rank Test in step-down sequence (10 mg to 5 mg)|Survival|||||||0.0383
72582518|NCT02490631|144695516|SUPERIORITY|||||||0.456|||||||Chi-squared|||||||0.456
72582519|NCT02490631|144695517|SUPERIORITY|||||||0.019|||||||Chi-squared|||||||.019
72582520|NCT05479435|144695518|OTHER|||||||0.83|||||||Kruskal-Wallis|||||||0.830
72582521|NCT05479435|144695519|OTHER|||||||0.654|||||||ANCOVA|||||||0.654
72582522|NCT05479435|144695520|OTHER|||||||0.803|||||||ANCOVA|||||||0.803
72582523|NCT05479435|144695521|OTHER|||||||0.398|||||||ANCOVA|||||||0.398
72582524|NCT05479435|144695522|OTHER|||||||0.132|||||||Kruskal-Wallis|||||||0.132
72582525|NCT05479435|144695523|OTHER|||||||0.991|||||||Kruskal-Wallis|||||||0.991
72582526|NCT05479435|144695524|OTHER|||||||0.278|||||||Kruskal-Wallis|||||||0.278
72582527|NCT05479435|144695525|OTHER|||||||0.479|||||||ANCOVA|||||||0.479
72582528|NCT05479435|144695526|OTHER|||||||0.849|||||||Kruskal-Wallis|||||||0.849
72582529|NCT05479435|144695527|OTHER|||||||0.504|||||||Kruskal-Wallis|||||||0.504
72582530|NCT05479435|144695528|OTHER|||||||0.017|||||||ANCOVA|||||||0.017
72582531|NCT05479435|144695529|OTHER|||||||0.025|||||||Kruskal-Wallis|||||||0.025
72582532|NCT05479435|144695530|OTHER|||||||0.016|||||||ANCOVA|||||||0.016
72582533|NCT05479435|144695531|OTHER|||||||0.041|||||||ANCOVA|||||||0.041
72582534|NCT05479435|144695532|OTHER|||||||0.352|||||||Kruskal-Wallis|||||||0.352
72582535|NCT05479435|144695533|OTHER|||||||0.39|||||||Kruskal-Wallis|||||||0.390
72582536|NCT05479435|144695534|OTHER|||||||0.928|||||||ANCOVA|||||||0.928
72582537|NCT05479435|144695535|OTHER|||||||0.558|||||||Kruskal-Wallis|||||||0.558
72582538|NCT05479435|144695536|OTHER|||||||0.133|||||||Kruskal-Wallis|||||||0.133
72582539|NCT05479435|144695537|OTHER|||||||0.367|||||||Kruskal-Wallis|||||||0.367
72582540|NCT05479435|144695538|OTHER|||||||0.631|||||||ANCOVA|||||||0.631
72582541|NCT05479435|144695539|OTHER|||||||0.056|||||||ANCOVA|||||||0.056
72582542|NCT05479435|144695540|OTHER|||||||0.979|||||||ANCOVA|||||||0.979
72582543|NCT05479435|144695541|OTHER|||||||0.377|||||||ANCOVA|||||||0.377
72582544|NCT05479435|144695542|OTHER|||||||0.979|||||||ANCOVA|||||||0.979
72582545|NCT05479435|144695543|OTHER|||||||0.055|||||||ANCOVA|||||||0.055
72582546|NCT02546986|144695544|SUPERIORITY||Hazard Ratio (HR)|1.374||||0.1789|TWO_SIDED|90.0|0.926|2.038|||Stratified Log-Rank Test|Stratified by squamous cell carcinoma versus non-squamous cell carcinoma|Hazard ratio and associated 2-sided 90% CIs were estimated using a Cox proportional hazard model|||2.038|0.926|0.1789
72582547|NCT02546986|144695545|SUPERIORITY||Disease Control Rate Difference|-13.3||||0.1572|TWO_SIDED|90.0|-29.0|3.5|||Cochran-Mantel-Haenszel|Stratified by squamous cell carcinoma vs non-squamous cell carcinoma||||3.5|-29.0|0.1572
72582548|NCT02546986|144695546|SUPERIORITY||Hazard Ratio (HR)|1.375||||0.2968|TWO_SIDED|90.0|0.83|2.276|||Stratified Log Rank|Stratified by squamous cell carcinoma vs non-squamous cell carcinoma).|Hazard ratio and associated 2-sided 90% CIs were estimated using Cox proportional hazard model.|||2.276|0.830|0.2968
72582549|NCT02546986|144695547|SUPERIORITY||Overall Response Rate (ORR) Difference|5.3|||||TWO_SIDED|90.0|-11.5|21.3|||||The 90% exact unconditional confidence interval was used for ORR difference.|||21.3|-11.5|
72582550|NCT02546986|144695549|SUPERIORITY||Hazard Ratio (HR)|1.352||||0.199|TWO_SIDED|90.0|0.914|2.0|||Stratified Log-Rank Test|Stratified by squamous cell carcinoma versus non-squamous cell carcinoma|Hazard ratio and associated 2-sided 90% CIs were estimated using a Cox proportional hazard model|||2.000|0.914|0.1990
72582551|NCT05016960|144695561|OTHER|one group paired samples t test to compare scores at pre vs. post treatment||||||0.503|||||||t-test, 2 sided|||||||.503
72582552|NCT05016960|144695562|NON_INFERIORITY|one group paired samples t test||||||0.23|||||||t-test, 2 sided|||||||.230
72582553|NCT05016960|144695563|OTHER|one group paired samples t test||||||0.061|||||||t-test, 2 sided|||||||.061
72582554|NCT05016960|144695564|OTHER|one group paired samples t test|||||<|0.001|||||||t-test, 2 sided|||||||<.001
72582555|NCT05016960|144695565|OTHER|one group paired samples t test||||||0.01|||||||t-test, 2 sided|||||||.01
72582556|NCT05016960|144695566|OTHER|one group paired samples t test||||||0.625|||||||t-test, 2 sided|||||||.625
72582557|NCT05016960|144695567|OTHER|one group paired samples t test||||||0.134|||||||t-test, 2 sided|||||||.134
72582558|NCT05016960|144695568|OTHER|one group paired samples t test||||||0.515|||||||t-test, 2 sided|||||||.515
72582559|NCT05016960|144695569|OTHER|one group paired samples t test||||||0.41|||||||t-test, 2 sided|||||||.410
72582560|NCT05016960|144695570|OTHER|one group paired samples t test||||||0.706|||||||t-test, 2 sided|||||||.706
72582561|NCT05016960|144695571|OTHER|one group paired samples t test||||||0.062|||||||t-test, 2 sided|||||||.062
72582562|NCT05016960|144695572|OTHER|one group paired samples t test||||||0.39|||||||t-test, 2 sided|||||||.390
72582563|NCT05016960|144695573|OTHER|one group paired samples t test||||||0.38|||||||t-test, 2 sided|||||||.38
72582564|NCT05016960|144695574|OTHER|One group paired samples t test||||||0.064|||||||t-test, 2 sided|||||||.064
72582565|NCT04796961|144695575|SUPERIORITY||Mean Difference (Net)|0.4|||||TWO_SIDED|95.0|0.1|0.7||||||||0.7|0.1|
72582566|NCT04796961|144695576|SUPERIORITY||Mean Difference (Net)|0.5|||||TWO_SIDED|95.0|-0.1|1.1||||||smoking screening||1.1|-0.1|
72582567|NCT04796961|144695576|SUPERIORITY||Mean Difference (Net)|0.6|||||TWO_SIDED|95.0|-0.1|1.2||||||readiness to quit assessments||1.2|-0.1|
72582568|NCT04796961|144695576|SUPERIORITY||Mean Difference (Net)|1.4|||||TWO_SIDED|95.0|0.8|2.0||||||smoking cessation counseling||2.0|0.8|
72582569|NCT04796961|144695576|SUPERIORITY||Mean Difference (Net)|0.6|||||TWO_SIDED|95.0|-0.5|1.7||||||smoking cessation pharmacotherapy||1.7|-0.5|
72582570|NCT03851406|144695678|OTHER||||||>|0.99||||||The a priori threshold for statistical significance is \< 0.05.|Wilcoxon (Mann-Whitney)|||||||> 0.99
72582571|NCT03851406|144695679|OTHER||||||>|0.99||||||The a priori threshold for statistical significance is \< 0.05.|Wilcoxon (Mann-Whitney)|||||||> 0.99
72582572|NCT03851406|144695680|OTHER||||||>|0.99||||||The a priori threshold for statistical significance is \< 0.05.|Wilcoxon (Mann-Whitney)|||4 hours post WSP exposure||||> 0.99
72582573|NCT03851406|144695680|OTHER||||||>|0.99||||||The a priori threshold for statistical significance is \< 0.05.|Wilcoxon (Mann-Whitney)|||24 hours post WSP exposure||||> 0.99
72582574|NCT03851406|144695681|OTHER|||||||0.38||||||The a priori threshold for statistical significance is \< 0.05.|Wilcoxon (Mann-Whitney)|||4 hours post WSP exposure||||0.38
72582575|NCT03851406|144695681|OTHER|||||||0.38||||||The a priori threshold for statistical significance is \< 0.05.|Wilcoxon (Mann-Whitney)|||24 hours post WSP exposure||||0.38
72582576|NCT03851406|144695682|OTHER|||||||0.25||||||The a priori threshold for statistical significance is \< 0.05.|Wilcoxon (Mann-Whitney)|||4 hours post WSP exposure||||0.25
72582577|NCT03851406|144695682|OTHER|||||||0.63||||||The a priori threshold for statistical significance is \< 0.05.|Wilcoxon (Mann-Whitney)|||24 hours post WSP exposure||||0.63
72582578|NCT03851406|144695683|OTHER|||||||0.88||||||The a priori threshold for statistical significance is \< 0.05.|Wilcoxon (Mann-Whitney)|||4 hours post WSP exposure||||0.88
72582579|NCT03851406|144695683|OTHER||||||>|0.99||||||The a priori threshold for statistical significance is \< 0.05.|Wilcoxon (Mann-Whitney)|||24 hours post WSP exposure||||>0.99
72582580|NCT03851406|144695684|OTHER|||||||0.88||||||The a priori threshold for statistical significance is \< 0.05.|Wilcoxon (Mann-Whitney)|||4 hours post WSP exposure||||0.88
72582581|NCT03851406|144695684|OTHER|||||||0.25||||||The a priori threshold for statistical significance is \< 0.05.|Wilcoxon (Mann-Whitney)|||24 hours post WSP exposure||||0.25
72582582|NCT03851406|144695685|OTHER||||||>|0.99||||||The a priori threshold for statistical significance is \< 0.05.|Wilcoxon (Mann-Whitney)|||4 hours post WSP exposure||||>0.99
72582583|NCT03851406|144695685|OTHER||||||>|0.99||||||The a priori threshold for statistical significance is \< 0.05.|Wilcoxon (Mann-Whitney)|||24 hours post WSP exposure||||>0.99
72582584|NCT03851406|144695686|OTHER|||||||0.75||||||The a priori threshold for statistical significance is \< 0.05.|Wilcoxon (Mann-Whitney)|||4 hours post WSP exposure||||0.75
72582585|NCT03851406|144695686|OTHER|||||||0.38||||||The a priori threshold for statistical significance is \< 0.05.|Wilcoxon (Mann-Whitney)|||24 hours post WSP exposure||||0.38
72582586|NCT03511105|144695688|OTHER||Absolute Difference|-30.46|STANDARD_ERROR_OF_MEAN|48.662|||TWO_SIDED|95.0|-127.07|65.51|||||Absolute difference (GSK2798745 - Placebo) and 95% CrI has been presented.|||65.51|-127.07|
72582587|NCT03511105|144695688|OTHER||Percentage change|8.73|STANDARD_ERROR_OF_MEAN|13.453|||TWO_SIDED|95.0|-21.41|31.3|||||Percentage change on GSK2798745 relative to placebo has been presented.|||31.30|-21.41|
72582588|NCT03511105|144695689|OTHER||Absolute Difference|-4.26|STANDARD_ERROR_OF_MEAN|13.679|||TWO_SIDED|95.0|-31.49|22.87|||||Absolute difference (GSK2798745 - Placebo) and 95% CrI have been presented.|||22.87|-31.49|
72582589|NCT03511105|144695689|OTHER||Percentage change|7.31|STANDARD_ERROR_OF_MEAN|22.837|||TWO_SIDED|95.0|-48.2|41.64|||||Percentage change on GSK2798745 relative to placebo has been presented.|||41.64|-48.20|
72412689|NCT02062502|144333451|SUPERIORITY_OR_OTHER||Antibody Response Rate|97.2|||<|0.001|TWO_SIDED|95.0|94.4|98.9|||Exact CI method/binomial proportion|||The conclusion of acceptability is based on the lower bound of the 95% Confidence Interval (CI) being \>76%, and implies that the value of the parameter is statistically significantly greater than the prespecified acceptability criterion (76%).||98.9|94.4|<0.001
72582590|NCT03511105|144695690|OTHER||Absolute Difference|-0.06|STANDARD_ERROR_OF_MEAN|3.178|||TWO_SIDED|95.0|-6.28|6.2|||||Absolute difference (GSK2798745 - Placebo) and 95% CrI have been presented.|||6.20|-6.28|
72582591|NCT03511105|144695690|OTHER||Percentage change|0.1|STANDARD_ERROR_OF_MEAN|5.429|||TWO_SIDED|95.0|-11.15|10.16|||||Percentage change on GSK2798745 relative to placebo has been presented.|||10.16|-11.15|
72582592|NCT02810457|144695714|EQUIVALENCE|A 90% CI for the ORR ratio between FKB238 and Avastin was estimated and compared to the margin (0.73 to 1.38), which was deemed to represent a clinically acceptable difference with respect to ORR. If the 90% CI was within the equivalence margin (0.73 to 1.38), an equivalence between FKB238 and Avastin, with respect to the ORR, was confirmed.|Ratio in ORR|0.96|||||TWO_SIDED|90.0|0.86|1.08||||||||1.08|0.86|
72582593|NCT02810457|144695715|OTHER|Ratio in ORR analysis of FKB238 versus Avastin.|Ratio in ORR|0.94|||||TWO_SIDED|90.0|0.83|1.06||||||Comparison between groups: Risk ratio in ORR at Week 19 by BICR.||1.06|0.83|
72582594|NCT02810457|144695716|OTHER|Hazard ratio analysis of FKB238 versus Avastin.|Hazard Ratio (HR)|0.97|||||TWO_SIDED|95.0|0.82|1.16|||||Treatment hazard ratio \<1 favors FKB238.|Hazard ratio and its 95% CI were calculated using the Cox regression model adjusting for baseline characteristics (randomization stratification factors, Eastern Cooperative Oncology Group (ECOG) performance status at baseline, gender, smoking history and age) with ties handled by the Efron method.||1.16|0.82|
72582595|NCT02810457|144695717|OTHER|Hazard ratio analysis of FKB238 versus Avastin.|Hazard Ratio (HR)|1.18|||||TWO_SIDED|95.0|0.96|1.45|||||Treatment hazard ratio \<1 favors FKB238.|Hazard ratio and its 95% CI were calculated using the Cox regression model adjusting for baseline characteristics (randomization stratification factors, ECOG performance status at baseline, gender, smoking history and age) with ties handled by the Efron method.||1.45|0.96|
72582596|NCT02810457|144695718|OTHER|Hazard ratio analysis of FKB238 versus Avastin.|Hazard Ratio (HR)|0.96|||||TWO_SIDED|95.0|0.74|1.23|||||Treatment hazard ratio \<1 favors FKB238.|Hazard ratio and its 95% CI were calculated using the Cox regression model adjusting for baseline characteristics (randomization stratification factors, ECOG performance status at baseline, gender, smoking history and age) with ties handled by the Efron method.||1.23|0.74|
72582597|NCT02810457|144695719|OTHER|Comparison between arms: Odds ratio.|Odds Ratio (OR)|1.01|||||TWO_SIDED|95.0|0.64|1.58|||||Odds ratio \>1 favors FKB238.|The DCR was compared between treatment arms using logistic regression adjusting for baseline characteristics (randomization stratification factors, ECOG performance status at baseline, gender, smoking history and age).||1.58|0.64|
72582598|NCT02019472|144695736|SUPERIORITY_OR_OTHER||LS mean difference|-0.76|||<|0.001|TWO_SIDED|95.0|-1.07|-0.46|||ANCOVA|||||-0.46|-1.07|< 0.001
72582599|NCT02019472|144695736|SUPERIORITY_OR_OTHER||Least Square (LS) mean difference|-0.39|||=|0.013|TWO_SIDED|95.0|-0.69|-0.08|||ANCOVA|||||-0.08|-0.69|=0.013
72582600|NCT02019472|144695737|SUPERIORITY_OR_OTHER||Percentage Difference|-4.8||||0.306|TWO_SIDED|95.0|-14.1|4.4|||Cochran-Mantel-Haenszel|||||4.4|-14.1|0.306
72582601|NCT02019472|144695737|SUPERIORITY_OR_OTHER||Percentage Difference|3.6||||0.464|TWO_SIDED|95.0|-6.0|13.1|||Cochran-Mantel-Haenszel|||||13.1|-6|0.464
72582602|NCT02019472|144695738|SUPERIORITY_OR_OTHER||Percentage Difference|5.4||||0.086|TWO_SIDED|95.0|-0.7|11.4|||Cochran-Mantel-Haenszel|||||11.4|-0.7|0.086
72582603|NCT02019472|144695738|SUPERIORITY_OR_OTHER||Percentage Difference|12.8|||<|0.001|TWO_SIDED|95.0|5.9|19.7|||Cochran-Mantel-Haenszel|||||19.7|5.9|< 0.001
72582604|NCT02019472|144695739|SUPERIORITY_OR_OTHER||Percentage Difference|-2.7||||0.603|TWO_SIDED|95.0|-12.8|7.4|||Cochran-Mantel-Haenszel|||||7.4|-12.8|0.603
72582605|NCT02019472|144695739|SUPERIORITY_OR_OTHER||Percentage Difference|2.4||||0.644|TWO_SIDED|95.0|-7.6|12.3|||Cochran-Mantel-Haenszel|||||12.3|-7.6|0.644
72582606|NCT03861390|144695740|OTHER|||||||0.24||||||The a priori threshold for statistical significance is \< 0.05.|Wilcoxon (Mann-Whitney)|||||||0.24
72582607|NCT03861390|144695741|OTHER|||||||0.17||||||The a priori threshold for statistical significance is \< 0.05.|Wilcoxon (Mann-Whitney)|||||||0.17
72582608|NCT03861390|144695742|OTHER|||||||0.7||||||The a priori threshold for statistical significance is \< 0.05.|Wilcoxon (Mann-Whitney)|||4 hours post WSP exposure||||0.70
72582609|NCT03861390|144695742|OTHER|||||||0.37||||||The a priori threshold for statistical significance is \< 0.05.|Wilcoxon (Mann-Whitney)|||24 hours post WSP exposure||||0.37
72582610|NCT03861390|144695743|OTHER|||||||0.77||||||The a priori threshold for statistical significance is \< 0.05.|Wilcoxon (Mann-Whitney)|||4 hours post WSP exposure||||0.77
72582611|NCT03861390|144695743|OTHER|||||||0.48||||||The a priori threshold for statistical significance is \< 0.05.|Wilcoxon (Mann-Whitney)|||24 hours post WSP exposure||||0.48
72582612|NCT03861390|144695744|OTHER|||||||0.96||||||The a priori threshold for statistical significance is \< 0.05.|Wilcoxon (Mann-Whitney)|||4 hours post WSP exposure||||0.96
72582613|NCT03861390|144695744|OTHER|||||||0.91||||||The a priori threshold for statistical significance is \< 0.05.|Wilcoxon (Mann-Whitney)|||24 hours post WSP exposure||||0.91
72582614|NCT03861390|144695745|OTHER|||||||0.46||||||The a priori threshold for statistical significance is \< 0.05.|Wilcoxon (Mann-Whitney)|||4 hours post WSP exposure||||0.46
72582615|NCT03861390|144695745|OTHER|||||||0.46||||||The a priori threshold for statistical significance is \< 0.05.|Wilcoxon (Mann-Whitney)|||24 hours post WSP exposure||||0.46
72582616|NCT03861390|144695746|OTHER|||||||0.82||||||The a priori threshold for statistical significance is \< 0.05.|Wilcoxon (Mann-Whitney)|||4 hours post WSP exposure||||0.82
72582617|NCT03861390|144695746|OTHER|The a priori threshold for statistical significance is \< 0.05.||||||0.99|||||||Wilcoxon (Mann-Whitney)|||24 hours post WSP exposure||||0.99
72582618|NCT03861390|144695747|OTHER|||||||0.38||||||The a priori threshold for statistical significance is \< 0.05.|Wilcoxon (Mann-Whitney)|||4 hours post WSP exposure||||0.38
72582619|NCT03861390|144695747|OTHER|||||||0.84||||||The a priori threshold for statistical significance is \< 0.05.|Wilcoxon (Mann-Whitney)|||24 hours post WSP exposure||||0.84
72582620|NCT03861390|144695748|OTHER|||||||0.49||||||The a priori threshold for statistical significance is \< 0.05.|Wilcoxon (Mann-Whitney)|||4 hours post WSP exposure||||0.49
72582621|NCT03861390|144695748|OTHER|||||||0.52||||||The a priori threshold for statistical significance is \< 0.05.|Wilcoxon (Mann-Whitney)|||24 hours post WSP exposure||||0.52
72549004|NCT02129348|144627792|SUPERIORITY||Treatment Effect Difference|0.2||||0.63|TWO_SIDED|95.0|-0.4|0.8||The threshold for statistical significance was p = 0.05.|Mixed Models Analysis|||In intent-to-treat analyses, linear mixed effect models (MEM) were used to estimate means of change scores (baseline versus 12 weeks) by treatment group, lithium versus placebo, for continuous outcomes. The MEM method was used to incorporate all time-points of assessment and deal with missing data for participants who did not reach the 12-week time-point.||0.8|-0.4|0.63
72549005|NCT02129348|144627793|SUPERIORITY||Treatment Effect Difference|3.2||||0.24|TWO_SIDED|95.0|-2.1|8.4||The threshold of statistical significance was p = 0.05.|Mixed Models Analysis||Effect size (d)= 0.44 (Cohen's D)|In intent-to-treat analyses, linear mixed effect models (MEM) were used to estimate means of change scores (baseline versus 12 weeks) by treatment group, lithium versus placebo, for continuous outcomes. The MEM method was used to incorporate all time-points of assessment and deal with missing data for participants who did not reach the 12-week time-point.||8.4|-2.1|0.24
72549006|NCT02129348|144627794|SUPERIORITY||Treatment Effect Difference|0.0||||0.96|TWO_SIDED|95.0|-1.7|1.8||The threshold for statistical significance was p = 0.05.|Mixed Models Analysis||Cohen's d=0.01|In intent-to-treat analyses, linear mixed effect models (MEM) were used to estimate means of change scores (baseline versus 12 weeks) by treatment group, lithium versus placebo, for continuous outcomes. The MEM method was used to incorporate all time-points of assessment and deal with missing data for participants who did not reach the 12-week time-point.||1.8|-1.7|0.96
72549007|NCT02129348|144627795|SUPERIORITY||Treatment Effect Difference|2.2||||0.35|TWO_SIDED|95.0|-2.3|6.6||The threshold for statistical significance was p = 0.05.|Mixed Models Analysis||Cohen's d=0.35|In intent-to-treat analyses, linear mixed effect models (MEM) were used to estimate means of change scores (baseline versus 12 weeks) by treatment group, lithium versus placebo, for continuous outcomes. The MEM method was used to incorporate all time-points of assessment and deal with missing data for participants who did not reach the 12-week time-point.||6.6|-2.3|0.35
72549008|NCT03309956|144627876|SUPERIORITY|||||||0.23|||||||McNemar|||||||0.23
72549009|NCT02768298|144627879|SUPERIORITY||Least Squares (LS) Mean|0.32|STANDARD_ERROR_OF_MEAN|0.268||0.2327|TWO_SIDED|95.0|-0.21|0.85|||ANCOVA|||||0.85|-0.21|0.2327
72549010|NCT02768298|144627880|SUPERIORITY||LS Mean|-0.14|STANDARD_ERROR_OF_MEAN|0.277||0.6247|TWO_SIDED|95.0|-0.68|0.41|||ANCOVA|||||0.41|-0.68|0.6247
72549011|NCT02768298|144627881|SUPERIORITY||LS Mean|-1.23|STANDARD_ERROR_OF_MEAN|0.888||0.1678|TWO_SIDED|95.0|-2.98|0.52|||ANCOVA|||6 weeks||0.52|-2.98|0.1678
72549012|NCT02768298|144627881|SUPERIORITY||LS Mean|0.83|STANDARD_ERROR_OF_MEAN|0.809||0.3052|TWO_SIDED|95.0|-0.77|2.43|||ANCOVA|||3 months||2.43|-0.77|0.3052
72549013|NCT02768298|144627882|SUPERIORITY||LS Mean|0.87|STANDARD_ERROR_OF_MEAN|1.744||0.6181|TWO_SIDED|95.0|-2.58|4.32|||ANCOVA|||6 weeks||4.32|-2.58|0.6181
72549014|NCT02768298|144627882|SUPERIORITY||LS Mean|3.28|STANDARD_ERROR_OF_MEAN|2.124||0.1254|TWO_SIDED|95.0|-0.93|7.48|||ANCOVA|||3 months||7.48|-0.93|0.1254
72549015|NCT02768298|144627883|SUPERIORITY||LS Mean|-0.3|STANDARD_ERROR_OF_MEAN|0.317||0.3432|TWO_SIDED|95.0|-0.93|0.33|||ANCOVA|||Borg value dyspnea||0.33|-0.93|0.3432
72549016|NCT02768298|144627883|SUPERIORITY||LS Mean|0.16|STANDARD_ERROR_OF_MEAN|0.251||0.5319|TWO_SIDED|95.0|-0.34|0.65|||ANCOVA|||Borg value fatigue||0.65|-0.34|0.5319
72549017|NCT04634409|144627884|SUPERIORITY||Odds Ratio (OR)|0.37||||0.009273|TWO_SIDED|95.0|0.18|0.78|||Regression, Logistic|||||0.78|0.18|0.009273
72549018|NCT04634409|144627884|SUPERIORITY||Odds Ratio (OR)|0.32||||0.000271|TWO_SIDED|95.0|0.18|0.59|||Regression, Logistic|||||0.59|0.18|0.000271
72549019|NCT04634409|144627884|SUPERIORITY||Odds Ratio (OR)|0.23||||0.000257|TWO_SIDED|95.0|0.1|0.51|||Regression, Logistic|||||0.51|0.10|0.000257
72549020|NCT04634409|144627884|SUPERIORITY||Odds Ratio (OR)|0.44||||0.013378|TWO_SIDED|95.0|0.23|0.84|||Regression, Logistic|||||0.84|0.23|0.013378
72582622|NCT01217112|144695750|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.044||0.766|TWO_SIDED|90.0|-0.09|0.06|||ANCOVA|||Data was analysed by analysis of covariance (ANCOVA). The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.06|-0.09|0.766
72582623|NCT01217112|144695750|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.03|STANDARD_ERROR_OF_MEAN|0.043||0.424|TWO_SIDED|90.0|-0.04|0.11|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.11|-0.04|0.424
72582624|NCT01217112|144695750|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.03|STANDARD_ERROR_OF_MEAN|0.041||0.412|TWO_SIDED|90.0|-0.1|0.04|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.04|-0.10|0.412
72582625|NCT01217112|144695750|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.043||0.668|TWO_SIDED|90.0|-0.05|0.09|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.09|-0.05|0.668
72582626|NCT01217112|144695751|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.046||0.978|TWO_SIDED|90.0|-0.08|0.08|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.08|-0.08|0.978
72582627|NCT01217112|144695751|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.045||0.864|TWO_SIDED|90.0|-0.08|0.07|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.07|-0.08|0.864
72582628|NCT01217112|144695751|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.03|STANDARD_ERROR_OF_MEAN|0.05||0.537|TWO_SIDED|90.0|-0.12|0.05|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.05|-0.12|0.537
72582629|NCT01217112|144695751|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.045||0.26|TWO_SIDED|90.0|-0.02|0.13|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.13|-0.02|0.260
72412690|NCT00489970|144333465|NON_INFERIORITY|One month after vaccination, the lower limit of the 97.5% confidence interval (CI) for the difference between groups in the seroprotection rate \[a second dose of Boostrix (Boostrix group) minus the first dose of Boostrix (Control group)\] against diphtheria antigen was greater than or equal to -10% (clinical limit for non-inferiority).|Difference in percentage|1.41|||||TWO_SIDED|97.5|-1.16|4.17|||||Standardized asymptotic 97.5% CI for the group difference in the seroprotection rate was calculated.|To demonstrate that the immune response elicited by a second dose of Boostrix vaccine (Boostrix group and Control group) was non-inferior to the immune response elicited by a first dose of Boostrix vaccine (Control group), with respect to seroprotection rate against diphtheria antigen, one month following vaccination.||4.17|-1.16|
72412691|NCT00489970|144333465|NON_INFERIORITY|One month after vaccination, the lower limit of the 97.5% confidence interval (CI) for the difference between groups in the seroprotection rate \[a second dose of Boostrix (Boostrix group) minus the first dose of Boostrix (Control group)\] against tetanus antigen was greater than or equal to -10% (clinical limit for non-inferiority).|Difference in percentage|0.31|||||TWO_SIDED|97.5|-1.52|2.07|||||Standardized asymptotic 97.5% CI for the group difference in the seroprotection rate was calculated.|To demonstrate that the immune response elicited by a second dose of Boostrix vaccine (Boostrix group and Control group) was non-inferior to the immune response elicited by a first dose of Boostrix vaccine (Control group), with respect to seroprotection rate against tetanus antigen, one month following vaccination.||2.07|-1.52|
72412692|NCT00489970|144333465|NON_INFERIORITY|One month after vaccination, the lower limit of the 97.5% CI for the difference between groups in the seroprotection rate \[a second dose of Boostrix (Adacel group) minus the first dose of Boostrix (Control group)\] against diphtheria antigen was greater than or equal to -10% (clinical limit for non-inferiority).|Difference in percentage|1.32|||||TWO_SIDED|97.5|-3.41|4.15|||||Standardized asymptotic 97.5% CI for the group difference in the seroprotection rate was calculated.|To demonstrate that the immune response elicited by a second dose of Boostrix vaccine (Adacel group and Control group) was non-inferior to the immune response elicited by a first dose of Boostrix vaccine (Control group), with respect to seroprotection rate against diphtheria antigen, one month following vaccination.||4.15|-3.41|
72412693|NCT00489970|144333465|NON_INFERIORITY|One month after vaccination, the lower limit of the 97.5% CI for the difference between groups in the seroprotection rate \[a second dose of Boostrix (Adacel group) minus the first dose of Boostrix (Control group)\] against tetanus antigen was greater than or equal to -10% (clinical limit for non-inferiority).|Difference in percentage|0.31|||||TWO_SIDED|97.5|-3.69|2.07|||||Standardized asymptotic 97.5% CI for the group difference in the seroprotection rate was calculated.|To demonstrate that the immune response elicited by a second dose of Boostrix vaccine (Adacel group and Control group) was non-inferior to the immune response elicited by a first dose of Boostrix vaccine (Control group), with respect to seroprotection rate against tetanus antigen, one month following vaccination.||2.07|-3.69|
72412694|NCT00489970|144333467|NON_INFERIORITY|One month after vaccination, the lower limits of the 97.5% CIs for the anti-PT GMC ratios (Boostrix Group divided by Infanrix Group in APV-039) were greater than or equal to 0.67|GMC ratio|1.53|||||TWO_SIDED|97.5|1.31|1.79|||GMC ratio|The associated CI was derived using the method proposed by G.Y. Zou and A. Donner \[Zou, 2008\]||To demonstrate that the immune response elicited by a second dose of Tdap vaccine, Boostrix (Boostrix Group) was non-inferior to the immune response elicited by a three dose series of Infanrix vaccine in infants in the German household contact efficacy study APV-039, with respect to antibodies against anti-PT one month following vaccination||1.79|1.31|
72412695|NCT00489970|144333467|NON_INFERIORITY|One month after vaccination, the lower limits of the 97.5% CIs for the anti-FHA GMC ratios (Boostrix Group divided by Infanrix Group in APV-039) were greater than or equal to 0.67|GMC ratio|5.27|||||TWO_SIDED|97.5|4.62|6.01|||GMC ratio|The associated CI was derived using the method proposed by G.Y. Zou and A. Donner \[Zou, 2008\]||To demonstrate that the immune response elicited by a second dose of Tdap vaccine, Boostrix (Boostrix Group) was non-inferior to the immune response elicited by a three dose series of Infanrix vaccine in infants in the German household contact efficacy study APV-039, with respect to antibodies against anti-FHA one month following vaccination||6.01|4.62|
72412696|NCT00489970|144333467|NON_INFERIORITY|One month after vaccination, the lower limits of the 97.5% CIs for the anti-PRN GMC ratios (Boostrix Group divided by Infanrix Group in APV-039) were greater than or equal to 0.67|GMC ratio|3.62|||||TWO_SIDED|97.5|3.07|4.25|||GMC ratio|The associated CI was derived using the method proposed by G.Y. Zou and A. Donner \[Zou, 2008\]||To demonstrate that the immune response elicited by a second dose of Tdap vaccine, Boostrix (Boostrix Group) was non-inferior to the immune response elicited by a three dose series of Infanrix vaccine in infants in the German household contact efficacy study APV-039, with respect to antibodies against anti-PRN one month following vaccination||4.25|3.07|
72412697|NCT00489970|144333467|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|One month after vaccination, the lower limits of the 97.5% CIs for the anti-PT GMC ratios (Adacel Group divided by Infanrix Group in APV-039) were greater than or equal to 0.67|GMC ratio|1.64||||||97.5|1.33|2.03|||GMC ratio|The associated CI was derived using the method proposed by G.Y. Zou and A. Donner \[Zou, 2008\]||To demonstrate that the immune response elicited by a second dose of Tdap vaccine, Boostrix (Adacel Group) was non-inferior to the immune response elicited by a three dose series of Infanrix vaccine in infants in the German household contact efficacy study APV-039, with respect to antibodies against anti-PT one month following vaccination||2.03|1.33|
72412698|NCT00489970|144333467|NON_INFERIORITY|One month after vaccination, the lower limits of the 97.5% CIs for the anti-FHA GMC ratios (Adacel Group divided by Infanrix Group in APV-039) were greater than or equal to 0.67|GMC ratio|5.27|||||TWO_SIDED|97.5|4.37|6.36|||GMC ratio|The associated CI was derived using the method proposed by G.Y. Zou and A. Donner \[Zou, 2008\]||To demonstrate that the immune response elicited by a second dose of Tdap vaccine, Boostrix (Adacel Group) was non-inferior to the immune response elicited by a three dose series of Infanrix vaccine in infants in the German household contact efficacy study APV-039, with respect to antibodies against anti-FHA one month following vaccination||6.36|4.37|
72549021|NCT04634409|144627884|SUPERIORITY||Odds Ratio (OR)|0.24||||0.000318|TWO_SIDED|95.0|0.11|0.52|||Regression, Logistic|||||0.52|0.11|0.000318
72549022|NCT04634409|144627884|SUPERIORITY||Odds Ratio (OR)|0.35||||0.140563|TWO_SIDED|95.0|0.09|1.41|||Regression, Logistic|||||1.41|0.09|0.140563
72582630|NCT01217112|144695752|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.31|STANDARD_ERROR_OF_MEAN|0.18||0.088|TWO_SIDED|90.0|-0.61|-0.01|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||-0.01|-0.61|0.088
72582631|NCT01217112|144695752|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.177||0.583|TWO_SIDED|90.0|-0.2|0.39|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.39|-0.20|0.583
72582632|NCT01217112|144695752|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.15|STANDARD_ERROR_OF_MEAN|0.169||0.388|TWO_SIDED|90.0|-0.14|0.43|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.43|-0.14|0.388
72582633|NCT01217112|144695752|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.09|STANDARD_ERROR_OF_MEAN|0.17||0.58|TWO_SIDED|90.0|-0.19|0.38|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.38|-0.19|0.580
72549023|NCT04634409|144627885|SUPERIORITY||Odds Ratio (OR)|0.27||||0.000835|TWO_SIDED|95.0|0.12|0.58|||Regression, Logistic|||||0.58|0.12|0.000835
72549024|NCT04634409|144627886|SUPERIORITY||Odds Ratio (OR)|0.56||||0.097231|TWO_SIDED|95.0|0.28|1.11|||Regression, Logistic|||||1.11|0.28|0.097231
72549025|NCT04634409|144627886|SUPERIORITY||Odds Ratio (OR)|0.59||||0.13236|TWO_SIDED|95.0|0.3|1.17|||Regression, Logistic|||||1.17|0.30|0.132360
72549026|NCT04634409|144627892|SUPERIORITY||Odds Ratio (OR)|0.62||||0.769|TWO_SIDED|95.0|0.02|15.57|||Regression, Logistic|||||15.57|0.02|0.769
72549027|NCT04634409|144627892|SUPERIORITY||Odds Ratio (OR)|0.32||||0.494|TWO_SIDED|95.0|0.01|8.12|||Regression, Logistic|||||8.12|0.01|0.494
72549028|NCT04634409|144627892|SUPERIORITY||Odds Ratio (OR)|0.5||||0.671|TWO_SIDED|95.0|0.02|12.51|||Regression, Logistic|||||12.51|0.02|0.671
72549029|NCT04634409|144627892|SUPERIORITY||Odds Ratio (OR)|0.49||||0.663|TWO_SIDED|95.0|0.02|12.27|||Regression, Logistic|||||12.27|0.02|0.663
72549030|NCT04634409|144627892|SUPERIORITY||Odds Ratio (OR)|0.51||||0.68|TWO_SIDED|95.0|0.02|12.76|||Regression, Logistic|||||12.76|0.02|0.680
72549031|NCT04634409|144627892|SUPERIORITY||Odds Ratio (OR)|2.51||||0.584|TWO_SIDED|95.0|0.09|67.88|||Regression, Logistic|||||67.88|0.09|0.584
72549032|NCT04634409|144627894|SUPERIORITY||Odds Ratio (OR)|1.02||||0.979|TWO_SIDED|95.0|0.17|6.06|||Regression, Logistic|||||6.06|0.17|0.979
72549033|NCT04634409|144627894|SUPERIORITY||Odds Ratio (OR)|1.42||||0.675|TWO_SIDED|95.0|0.27|7.39|||Regression, Logistic|||||7.39|0.27|0.675
72549034|NCT04634409|144627897|SUPERIORITY||LSM Difference|-0.67||||0.009|TWO_SIDED|95.0|-1.17|-0.17|||Mixed Models Analysis|||||-0.17|-1.17|0.009
72549035|NCT04634409|144627897|SUPERIORITY||LSM Difference|-0.65||||0.002|TWO_SIDED|95.0|-1.06|-0.24|||Mixed Models Analysis|||||-0.24|-1.06|0.002
72549036|NCT04634409|144627897|SUPERIORITY||LSM Difference|-0.26||||0.263|TWO_SIDED|95.0|-0.72|0.2|||Mixed Models Analysis|||||0.20|-0.72|0.263
72549037|NCT04634409|144627897|SUPERIORITY||LSM Difference|-0.41||||0.083|TWO_SIDED|95.0|-0.87|0.05|||Mixed Models Analysis|||||0.05|-0.87|0.083
72549038|NCT04634409|144627897|SUPERIORITY||LSM Difference|-0.87|||<|0.001|TWO_SIDED|95.0|-1.35|-0.4|||Mixed Models Analysis|||||-0.40|-1.35|<0.001
72549039|NCT04634409|144627897|SUPERIORITY||LSM Difference|-0.64||||0.149|TWO_SIDED|95.0|-1.52|0.23|||Mixed Models Analysis|||||0.23|-1.52|0.149
72549040|NCT04634409|144627898|SUPERIORITY||LSM Difference|-0.82||||0.002|TWO_SIDED|95.0|-1.33|-0.31|||Mixed Models Analysis|||||-0.31|-1.33|0.002
72549041|NCT04634409|144627899|SUPERIORITY||LSM Difference|-0.14||||0.606|TWO_SIDED|95.0|-0.7|0.41|||Mixed Models Analysis|||||0.41|-0.70|0.606
72549042|NCT04634409|144627899|SUPERIORITY||LSM Difference|-0.38||||0.17|TWO_SIDED|95.0|-0.93|0.17|||Mixed Models Analysis|||||0.17|-0.93|0.170
72549043|NCT04634409|144627905|SUPERIORITY||Odds Ratio (OR)|0.96||||0.89|TWO_SIDED|95.0|0.53|1.73|||Regression, Logistic|||||1.73|0.53|0.890
72549044|NCT04634409|144627905|SUPERIORITY||Odds Ratio (OR)|1.43||||0.141|TWO_SIDED|95.0|0.89|2.29|||Regression, Logistic|||||2.29|0.89|0.141
72549045|NCT04634409|144627905|SUPERIORITY||Odds Ratio (OR)|1.15||||0.603|TWO_SIDED|95.0|0.67|1.98|||Regression, Logistic|||||1.98|0.67|0.603
72549046|NCT04634409|144627905|SUPERIORITY||Odds Ratio (OR)|1.69||||0.048|TWO_SIDED|95.0|1.0|2.84|||Regression, Logistic|||||2.84|1.00|0.048
72549047|NCT04634409|144627905|SUPERIORITY||Odds Ratio (OR)|1.19||||0.533|TWO_SIDED|95.0|0.69|2.04|||Regression, Logistic|||||2.04|0.69|0.533
72549048|NCT04634409|144627905|SUPERIORITY||Odds Ratio (OR)|1.09||||0.869|TWO_SIDED|95.0|0.4|2.99|||Regression, Logistic|||||2.99|0.40|0.869
72549049|NCT04634409|144627906|SUPERIORITY||Odds Ratio (OR)|1.31||||0.374|TWO_SIDED|95.0|0.72|2.35|||Regression, Logistic|||||2.35|0.72|0.374
72549050|NCT04634409|144627907|SUPERIORITY||Odds Ratio (OR)|1.87||||0.015|TWO_SIDED|95.0|1.13|3.08|||Regression, Logistic|||||3.08|1.13|0.015
72549051|NCT04634409|144627907|SUPERIORITY||Odds Ratio (OR)|1.29||||0.317|TWO_SIDED|95.0|0.78|2.11|||Regression, Logistic|||||2.11|0.78|0.317
72549052|NCT04634409|144627910|SUPERIORITY||Odds Ratio (OR)|1.62||||0.082|TWO_SIDED|95.0|0.94|2.81|||Regression, Logistic|||||2.81|0.94|0.082
72549053|NCT04634409|144627910|SUPERIORITY||Odds Ratio (OR)|1.86||||0.018|TWO_SIDED|95.0|1.11|3.11|||Regression, Logistic|||||3.11|1.11|0.018
72549054|NCT04634409|144627910|SUPERIORITY||Odds Ratio (OR)|1.71||||0.021|TWO_SIDED|95.0|1.09|2.71|||Regression, Logistic|||||2.71|1.09|0.021
72549055|NCT04634409|144627910|SUPERIORITY||Odds Ratio (OR)|1.93||||0.011|TWO_SIDED|95.0|1.16|3.22|||Regression, Logistic|||||3.22|1.16|0.011
72549056|NCT04634409|144627910|SUPERIORITY||Odds Ratio (OR)|2.17||||0.003|TWO_SIDED|95.0|1.3|3.6|||Regression, Logistic|||||3.60|1.30|0.003
72549057|NCT04634409|144627910|SUPERIORITY||Odds Ratio (OR)|1.34||||0.546|TWO_SIDED|95.0|0.52|3.48|||Regression, Logistic|||||3.48|0.52|0.546
72549058|NCT04634409|144627911|SUPERIORITY||Odds Ratio (OR)|1.04||||0.888|TWO_SIDED|95.0|0.6|1.82|||Regression, Logistic|||||1.82|0.60|0.888
72549059|NCT04634409|144627912|SUPERIORITY||Odds Ratio (OR)|1.88||||0.014|TWO_SIDED|95.0|1.13|3.13|||Regression, Logistic|||||3.13|1.13|0.014
72549060|NCT04634409|144627912|SUPERIORITY||Odds Ratio (OR)|1.63||||0.057|TWO_SIDED|95.0|0.98|2.71|||Regression, Logistic|||||2.71|0.98|0.057
72549061|NCT02518685|144627924|SUPERIORITY||Least-Square Mean Difference|6.7|||<|0.0001|TWO_SIDED|95.0|4.54|8.81|||multiple imputations|||||8.81|4.54|<0.0001
72549062|NCT02518685|144627925|SUPERIORITY|Statistical success criterion for achieving the performance standard of (≥ 50%) of proportion of TPS subjects who have 5% or more TBL at the 12-Month Follow-up|Proportion of Subjects|66.8|||<|0.0001|TWO_SIDED|95.0|59.3|74.3|||Wilson's Midpoint Estimate|||||74.3|59.3|<0.0001
72549063|NCT01611090|144627926|SUPERIORITY||Hazard Ratio (HR)|0.229|||<|0.0001|TWO_SIDED|95.0|0.183|0.286|||Log Rank|||||0.286|0.183|< 0.0001
72549064|NCT01210001|144627952|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.48|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001|TWO_SIDED|97.5|-0.69|-0.27||Hierarchical testing to adjust for multiple comparisons within each dose level, alpha split equally between the doses (2.5%). Empa versus placebo change from baseline in HbA1c was the first step in each hierarchical sequence.|ANCOVA|Based on ANCOVA with terms for treatment, background antidiabetic medication, renal function at baseline and baseline HbA1c.|Difference calculated as empa 10mg minus placebo|||-0.27|-0.69|<0.0001
72549065|NCT01210001|144627952|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.61|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001|TWO_SIDED|97.5|-0.82|-0.4||Hierarchical testing to adjust for multiple comparisons within each dose level, alpha split equally between the doses (2.5%). Empa versus placebo change from baseline in HbA1c was the first step in each hierarchical sequence.|ANCOVA|Based on ANCOVA with terms for treatment, background antidiabetic medication, renal function at baseline and baseline HbA1c.|Difference calculated as empa 25mg minus placebo|||-0.40|-0.82|<0.0001
72549066|NCT01210001|144627953|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-23.48|STANDARD_ERROR_OF_MEAN|3.71|<|0.0001|TWO_SIDED|97.5|-31.81|-15.15||Hierarchical testing to adjust for multiple comparisons within each dose level, alpha split equally between the doses (2.5%). Empa versus placebo change from baseline in FPG was the second step in each hierarchical sequence.|ANCOVA|Based on ANCOVA with terms for treatment, background antidiabetic medication, renal function at baseline, baseline HbA1c and baseline FPG|Difference calculated as empa 10mg minus placebo|||-15.15|-31.81|<0.0001
72549067|NCT01210001|144627953|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-28.46|STANDARD_ERROR_OF_MEAN|3.68|<|0.0001|TWO_SIDED|97.5|-36.73|-20.19||Hierarchical testing to adjust for multiple comparisons within each dose level, alpha split equally between the doses (2.5%). Empa versus placebo change from baseline in FPG was the second step in each hierarchical sequence.|ANCOVA|Based on ANCOVA with terms for treatment, background antidiabetic medication, renal function at baseline, baseline HbA1c and baseline FPG|Difference calculated as empa 25mg minus placebo|||-20.19|-36.73|<0.0001
72549068|NCT01210001|144627954|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.95|STANDARD_ERROR_OF_MEAN|0.3|<|0.0001|TWO_SIDED|97.5|-2.64|-1.27||Hierarchical testing to adjust for multiple comparisons within each dose level, alpha split equally between the doses (2.5%). Empa versus placebo change from baseline in body weight was the third step in each hierarchical sequence.|ANCOVA|Based on ANCOVA with terms for treatment, background antidiabetic medication, renal function at baseline, baseline HbA1c and baseline weight|Difference calculated as empa 10mg minus placebo|||-1.27|-2.64|<0.0001
72549069|NCT01210001|144627954|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.81|STANDARD_ERROR_OF_MEAN|0.3|<|0.0001|TWO_SIDED|97.5|-2.49|-1.13||Hierarchical testing to adjust for multiple comparisons within each dose level, alpha split equally between the doses (2.5%). Empa versus placebo change from baseline in body weight was the third step in each hierarchical sequence.|ANCOVA|Based on ANCOVA with terms for treatment, background antidiabetic medication, renal function at baseline, baseline HbA1c and baseline weight|Difference calculated as empa 25mg minus placebo|||-1.13|-2.49|<0.0001
72549070|NCT01210001|144627955|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.45|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001|TWO_SIDED|97.5|-0.69|-0.21||Hierarchical testing to adjust for multiple comparisons within each dose level, alpha split equally between the doses (2.5%). Empa vs placebo change from baseline in HbA1c for pio+met background only was the fourth step in each hierarchical sequence.|ANCOVA|Based on ANCOVA with terms for treatment, background antidiabetic medication, renal function at baseline and baseline HbA1c.|Difference calculated as empa 10mg minus placebo|||-0.21|-0.69|<0.0001
72549071|NCT01210001|144627955|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001|TWO_SIDED|97.5|-0.83|-0.36||Hierarchical testing to adjust for multiple comparisons within each dose level, alpha split equally between the doses (2.5%). Empa vs placebo change from baseline in HbA1c for pio+met background only was the fourth step in each hierarchical sequence.|ANCOVA|Based on ANCOVA with terms for treatment, background antidiabetic medication, renal function at baseline and baseline HbA1c.|Difference calculated as empa 25mg minus placebo|||-0.36|-0.83|<0.0001
72549072|NCT01739790|144627957|OTHER|||||||0.45|||||||Fisher Exact|||||||0.45
72549073|NCT02122796|144627959|SUPERIORITY_OR_OTHER||||||<|0.01||||||Means of pre- and post-treatment measurements were compared using paired, two-sided Student's t tests. P values were calculated comparing acupuncture and control mean change scores using unpaired two-sided Student's t tests.|t-test, 2 sided|P values were calculated comparing acupuncture and control mean change scores using unpaired two-sided Student's t tests.||||||<0.01
72582634|NCT01217112|144695753|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.04|STANDARD_ERROR_OF_MEAN|0.198||0.829|TWO_SIDED|90.0|-0.29|0.37|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.37|-0.29|0.829
72582635|NCT01217112|144695753|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.11|STANDARD_ERROR_OF_MEAN|0.196||0.575|TWO_SIDED|90.0|-0.22|0.44|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.44|-0.22|0.575
72582636|NCT01217112|144695753|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.19|STANDARD_ERROR_OF_MEAN|0.203||0.356|TWO_SIDED|90.0|-0.15|0.53|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.53|-0.15|0.356
72582637|NCT01217112|144695753|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.14|STANDARD_ERROR_OF_MEAN|0.188||0.472|TWO_SIDED|90.0|-0.18|0.45|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.45|-0.18|0.472
72549074|NCT02122796|144627960|SUPERIORITY_OR_OTHER||||||<|0.01||||||Means of pre- and post-treatment measurements were compared using paired, two-sided Student's t tests. P values were calculated comparing acupuncture and control mean change scores using unpaired two-sided Student's t tests.|t-test, 2 sided|P values were calculated comparing acupuncture and control mean change scores using unpaired two-sided Student's t tests.||||||<0.01
72549075|NCT02122796|144627962|SUPERIORITY_OR_OTHER||||||<|0.01||||||Means of pre- and post-treatment measurements were compared using paired, two-sided Student's t tests. P values were calculated comparing acupuncture and control mean change scores using unpaired two-sided Student's t tests.|t-test, 2 sided|P values were calculated comparing acupuncture and control mean change scores using unpaired two-sided Student's t tests.||||||<0.01
72582638|NCT01217112|144695754|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.29|STANDARD_ERROR_OF_MEAN|0.181||0.115|TWO_SIDED|90.0|-0.59|0.01|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.01|-0.59|0.115
72582639|NCT01217112|144695754|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.177||0.782|TWO_SIDED|90.0|-0.25|0.35|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.35|-0.25|0.782
72582640|NCT01217112|144695754|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.173||0.902|TWO_SIDED|90.0|-0.27|0.31|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.31|-0.27|0.902
72582641|NCT01217112|144695754|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.166||0.993|TWO_SIDED|90.0|-0.28|0.28|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.28|-0.28|0.993
72582642|NCT01217112|144695755|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.143||0.956|TWO_SIDED|90.0|-0.23|0.25|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.25|-0.23|0.956
72582643|NCT01217112|144695755|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.144||0.705|TWO_SIDED|90.0|-0.19|0.3|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.30|-0.19|0.705
72412699|NCT00489970|144333467|NON_INFERIORITY|One month after vaccination, the lower limits of the 97.5% CIs for the anti-PRN GMC ratios (Adacel Group divided by Infanrix Group in APV-039) were greater than or equal to 0.67|GMC ratio|4.47|||||TWO_SIDED|97.5|3.58|5.57|||GMC ratio|The associated CI was derived using the method proposed by G.Y. Zou and A. Donner \[Zou, 2008\]||To demonstrate that the immune response elicited by a second dose of Tdap vaccine, Boostrix (Adacel Group) was non-inferior to the immune response elicited by a three dose series of Infanrix vaccine in infants in the German household contact efficacy study APV-039, with respect to antibodies against anti-PRN one month following vaccination||5.57|3.58|
72412700|NCT00489970|144333468|NON_INFERIORITY|One month after vaccination, the lower limit of the 97.5% CI for the difference between groups in the booster response rate \[a second dose of Boostrix (Boostrix group) minus the first dose of Boostrix (Control group)\] against diphtheria antigen was greater than or equal to -10% (clinical limit for non-inferiority).|Difference in booster response rate|-5.91|||||TWO_SIDED|97.5|-14.67|2.85|||||Standardized asymptotic 97.5% CI for the group difference in the Booster response was calculated.|To demonstrate that the immune response elicited by a second dose of Boostrix vaccine (Boostrix group) was non-inferior to the immune response elicited by a first dose of Boostrix vaccine (Control group), with respect to booster response against diphtheria antigen, one month following vaccination.||2.85|-14.67|
72412701|NCT00489970|144333468|NON_INFERIORITY|One month after vaccination, the lower limit of the 97.5% CI for the difference between groups in the booster response rate \[a second dose of Boostrix (Boostrix group) minus the first dose of Boostrix (Control group)\] against tetanus antigen was greater than or equal to -10% (clinical limit for non-inferiority).|Difference in booster response rate|-1.44|||||TWO_SIDED|97.5|-10.63|7.79|||||Standardized asymptotic 97.5% CI for the group difference in the Booster response was calculated.|To demonstrate that the immune response elicited by a second dose of Boostrix vaccine (Boostrix group) was non-inferior to the immune response elicited by a first dose of Boostrix vaccine (Control group), with respect to booster response against tetanus antigen, one month following vaccination.||7.79|-10.63|
72582644|NCT01217112|144695755|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.11|STANDARD_ERROR_OF_MEAN|0.148||0.466|TWO_SIDED|90.0|-0.14|0.36|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.36|-0.14|0.466
72582645|NCT01217112|144695755|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.136||0.876|TWO_SIDED|90.0|-0.21|0.25|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.25|-0.21|0.876
72582646|NCT01217112|144695756|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.03|STANDARD_ERROR_OF_MEAN|0.034||0.408|TWO_SIDED|90.0|-0.03|0.09|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.09|-0.03|0.408
72582647|NCT01217112|144695756|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.032||0.714|TWO_SIDED|90.0|-0.04|0.07|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.07|-0.04|0.714
72582648|NCT01217112|144695756|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.04|STANDARD_ERROR_OF_MEAN|0.032||0.267|TWO_SIDED|90.0|-0.09|0.02|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.02|-0.09|0.267
72582649|NCT01217112|144695756|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.032||0.484|TWO_SIDED|90.0|-0.03|0.08|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.08|-0.03|0.484
72582650|NCT01217112|144695757|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.039||0.56|TWO_SIDED|90.0|-0.09|0.04|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.04|-0.09|0.560
72582651|NCT01217112|144695757|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.037||0.956|TWO_SIDED|90.0|-0.06|0.06|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.06|-0.06|0.956
72582652|NCT01217112|144695757|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.03|STANDARD_ERROR_OF_MEAN|0.039||0.403|TWO_SIDED|90.0|-0.1|0.03|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.03|-0.10|0.403
72582653|NCT01217112|144695757|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.037||0.617|TWO_SIDED|90.0|-0.04|0.08|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.08|-0.04|0.617
72582654|NCT01217112|144695758|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.03|STANDARD_ERROR_OF_MEAN|0.108||0.815|TWO_SIDED|90.0|-0.16|0.21|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.21|-0.16|0.815
72549076|NCT00502775|144627968|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.9|STANDARD_ERROR_OF_MEAN|0.16|<|0.001||95.0|-1.2|-0.6||Symptom scores were grouped in 3 families: nasal, ocular, instantaneous. Within each family, results of hypothesis tests were adjusted using Hochberg's method.|ANCOVA|No other strata or covariates, other than investigator, were defined.|Mean Difference = Mean Change in Fluticasone Furoate - Mean Change in Fexofenadine|The primary efficacy measure, mean change from baseline over the two-week treatment period in NSS compared between fluticasone furoate and fexofenadine, was assessed at a significance level of α=0.05. If the null hypothesis of this comparison was rejected, then the secondary measures were subject to hypothesis testing. The study was powered at 90%.||-0.6|-1.2|<0.001
72549077|NCT00502775|144627968|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.8|STANDARD_ERROR_OF_MEAN|0.16|<|0.001||95.0|-1.1|-0.4|||ANCOVA||Mean Difference = Mean Change in Fluticasone Furoate - Mean Change in Placebo|||-0.4|-1.1|<0.001
72549078|NCT00502775|144627968|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.1|STANDARD_ERROR_OF_MEAN|0.16||0.374||95.0|-0.2|0.5|||ANCOVA||Mean Difference = Mean Change in Fexofenadine - Mean Change in Placebo|||0.5|-0.2|0.374
72549079|NCT02906709|144628004|SUPERIORITY||Difference in the Least Squares Means|-0.9|||<|0.001|TWO_SIDED|95.0|-1.15|-0.66|||Constrained Longitudinal Data Analysis||||Based on a Constrained Longitudinal Data Analysis model with terms for treatment, prior AHA therapy status (yes/no), time and the interaction of time by treatment, time by prior anti-hyperglycemic agent (AHA) therapy status and time by treatment by prior AHA status with the restriction of a common baseline mean between two treatment groups.|-0.66|-1.15|<0.001
72549080|NCT02906709|144628005|SUPERIORITY||Difference in % vs. Placebo|7.0|||||TWO_SIDED|95.0|-8.4|21.8|||||||Based on Miettinen \& Nurminen method.|21.8|-8.4|
72549081|NCT02906709|144628007|SUPERIORITY||Difference in % vs. Placebo|-4.1|||||TWO_SIDED|95.0|-12.8|0.4|||||||Based on Miettinen \& Nurminen method.|0.4|-12.8|
72549082|NCT02906709|144628009|SUPERIORITY||Difference in the Least Squares Means|-15.0||||0.002|TWO_SIDED|95.0|-24.5|-5.4|||Constrained Longitudinal Data Analysis||||Based on a Constrained Longitudinal Data Analysis model with terms for treatment, prior AHA therapy status (yes/no), time and the interaction of time by treatment, time by prior AHA therapy status and time by treatment by prior AHA status with the restriction of a common baseline mean between two treatment groups.|-5.4|-24.5|0.002
72549083|NCT02906709|144628010|SUPERIORITY||Percent Between-group Rate Difference|5.8||||0.065|TWO_SIDED|95.0|-0.7|11.5|||Miettinen & Nurminen method||||The estimated response rates and effective sample sizes were used to obtain the confidence intervals (CIs) for within-group response rates via the Wilson score method. The CI were calculated via the stratified (non-combination prior AHA therapy status) Miettinen \& Nurminen method.|11.5|-0.7|0.065
72549084|NCT02906709|144628011|SUPERIORITY||Percent Between-group Rate Difference|1.6||||0.334|TWO_SIDED|95.0|-4.7|5.8|||Miettinen & Nurminen method||||The estimated response rates and effective sample sizes were used to obtain the confidence intervals (CIs) for within-group response rates via the Wilson score method. The CI were calculated via the stratified (non-combination prior AHA therapy status) Miettinen \& Nurminen method.|5.8|-4.7|0.334
72549085|NCT02906709|144628012|SUPERIORITY||Difference in the Least Squares Means|3.1|||<|0.001|TWO_SIDED|95.0|2.3|4.0|||Constrained Longitudinal Data Analysis||||Based on a Constrained Longitudinal Data Analysis model with terms for treatment, prior AHA therapy status (yes/no), time and the interaction of time by treatment, time by prior AHA therapy status and time by treatment by prior AHA status with the restriction of a common baseline mean between two treatment groups.|4.0|2.3|<0.001
72549086|NCT01124149|144628036|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.61|||<|0.001|TWO_SIDED|95.0|1.76|3.87|||Regression, Logistic|||||3.87|1.76|<0.001
72549087|NCT01124149|144628037|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.1|||<|0.001|TWO_SIDED|95.0|1.44|3.07|||Regression, Logistic|||||3.07|1.44|<0.001
72549088|NCT00977106|144628044|SUPERIORITY_OR_OTHER|||||||0.472|||||||Chi-squared|||||||0.472
72549089|NCT00977106|144628045|SUPERIORITY_OR_OTHER|||||||0.377||||||Between-group test (equal variances)|Student t-test|||Change at Week 1||||0.377
72549090|NCT00977106|144628045|SUPERIORITY_OR_OTHER|||||||0.276|||||||Student t-test|Between-group test (unequal variances)||Change at Week 4||||0.276
72549091|NCT00977106|144628047|SUPERIORITY_OR_OTHER|||||||0.502|||||||Student t-test|Between-group test (equal variances)||Change at Week 4||||0.502
72549092|NCT00977106|144628049|SUPERIORITY_OR_OTHER|||||||0.434||||||Between placebo and TCZ groups test (Equal Variances) at week 4|t-test, 1 sided|||||||0.434
72549093|NCT00977106|144628051|SUPERIORITY_OR_OTHER|||||||0.692|||||||Wilcoxon (Mann-Whitney)|||Change at Week 1||||0.692
72549094|NCT00977106|144628051|SUPERIORITY_OR_OTHER|||||||0.019|||||||Wilcoxon (Mann-Whitney)|||Change at Week 4||||0.019
72549095|NCT00977106|144628052|SUPERIORITY_OR_OTHER|||||||0.137|||||||Wilcoxon (Mann-Whitney)|||Change at Week 1||||0.137
72549096|NCT00977106|144628052|SUPERIORITY_OR_OTHER|||||||0.043|||||||Wilcoxon (Mann-Whitney)|||Change at Week 4||||0.043
72549097|NCT01644500|144628096|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analyses were based on a pre-defined non-inferiority margin of 0.4%.|Mean Difference (Net)|-0.58|||<|0.001|TWO_SIDED|95.0|-0.76|-0.39|||Mixed Models Analysis|||||-0.39|-0.76|<0.001
72549098|NCT01644500|144628096|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analyses were based on a pre-defined non-inferiority margin of 0.4%.|Mean Difference (Net)|-0.32|||<|0.001|TWO_SIDED|95.0|-0.5|-0.13|||Mixed Models Analysis|||||-0.13|-0.50|<0.001
72549099|NCT01644500|144628097|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.7|||<|0.001|TWO_SIDED|5.0|1.8|4.1||Treatment comparison for HbA1c ≤6.5%.|Fisher Exact|||||4.1|1.8|<0.001
72549100|NCT01644500|144628097|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.6|||<|0.001|TWO_SIDED|95.0|1.0|2.3||Treatment comparison for HbA1c ≤6.5%.|Fisher Exact|||||2.3|1.0|<0.001
72549101|NCT01644500|144628097|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.9|||<|0.001|TWO_SIDED|95.0|1.8|4.5||Treatment comparison for HbA1c \<7.0%.|Fisher Exact|||||4.5|1.8|<0.001
72549102|NCT01644500|144628097|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.6||||0.192|TWO_SIDED|95.0|1.1|2.5||Treatment comparison for HbA1c \<7.0%.|Fisher Exact|||||2.5|1.1|0.192
72549103|NCT01644500|144628098|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.83|||<|0.001|TWO_SIDED|95.0|-1.15|-0.51|||Mixed Models Analysis|||||-0.51|-1.15|<0.001
72549104|NCT01644500|144628098|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.38||||0.022|TWO_SIDED|95.0|-0.7|-0.05|||Mixed Models Analysis|||||-0.05|-0.70|0.022
72549105|NCT01644500|144628099|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.67|||<|0.001|TWO_SIDED|95.0|-0.89|-0.45||Treatment comparison for morning (fasting).|Mixed Models Analysis|||||-0.45|-0.89|<0.001
72549106|NCT01644500|144628099|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.12||||0.304|TWO_SIDED|95.0|-0.34|0.11||Treatment comparison for morning (fasting).|Mixed Models Analysis|||||0.11|-0.34|0.304
72549107|NCT01644500|144628099|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-1.36|||<|0.001|TWO_SIDED|95.0|-1.8|-0.92||Treatment comparison for morning (2 hours post-prandial) meal.|Mixed Models Analysis|||||-0.92|-1.80|<0.001
72549108|NCT01644500|144628099|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.55||||0.015|TWO_SIDED|95.0|-0.99|-0.11||Treatment comparison for morning (2 hours post-prandial) meal.|Mixed Models Analysis|||||-0.11|-0.99|0.015
72549109|NCT01644500|144628099|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.73|||<|0.001|TWO_SIDED|95.0|-1.1|-0.36||Treatment comparison for midday (pre-prandial) meal.|Mixed Models Analysis|||||-0.36|-1.10|<0.001
72549110|NCT01644500|144628099|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.06||||0.74|TWO_SIDED|95.0|-0.43|0.31||Treatment comparison for midday (pre-prandial) meal.|Mixed Models Analysis|||||0.31|-0.43|0.740
72549111|NCT01644500|144628099|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-1.56|||<|0.001|TWO_SIDED|95.0|-1.99|-1.13||Treatment comparison of midday (2 hours post-prandial) meal.|Mixed Models Analysis|||||-1.13|-1.99|<0.001
72549112|NCT01644500|144628099|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.81|||<|0.001|TWO_SIDED|95.0|-1.24|-0.39||Treatment comparison of midday (2 hours post-prandial) meal.|Mixed Models Analysis|||||-0.39|-1.24|<0.001
72549113|NCT01644500|144628099|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.67|||<|0.001|TWO_SIDED|95.0|-1.0|-0.34||Treatment comparison for evening (pre-prandial) meal.|Mixed Models Analysis|||||-0.34|-1.00|<0.001
72549114|NCT01644500|144628099|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.08||||0.638|TWO_SIDED|95.0|-0.41|0.25||Treatment comparison for evening (pre-prandial) meal.|Mixed Models Analysis|||||0.25|-0.41|0.638
72549115|NCT01644500|144628099|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-1.27|||<|0.001|TWO_SIDED|95.0|-1.68|-0.87||Treatment comparison for evening (2 hours post-prandial) meal.|Mixed Models Analysis|||||-0.87|-1.68|<0.001
72549116|NCT01644500|144628099|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.45||||0.03|TWO_SIDED|95.0|-0.85|-0.04||Treatment comparison for evening (2 hours post-prandial) meal.|Mixed Models Analysis|||||-0.04|-0.85|0.030
72549117|NCT01644500|144628099|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-1.19|||<|0.001|TWO_SIDED|95.0|-1.56|-0.82||Treatment comparison for bedtime.|Mixed Models Analysis|||||-0.82|-1.56|<0.001
72549118|NCT01644500|144628099|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.66|||<|0.001|TWO_SIDED|95.0|-1.03|-0.29||Treatment comparison for bedtime.|Mixed Models Analysis|||||-0.29|-1.03|<0.001
72549119|NCT01644500|144628100|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||Treatment comparison for all hypoglycemic episodes.|Negative binomial regression model|||||||<0.001
72549120|NCT01644500|144628100|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||Treatment comparison for all hypoglycemic episodes.|Negative binomial regression model|||||||<0.001
72549121|NCT01644500|144628100|SUPERIORITY_OR_OTHER_LEGACY|||||||0.008||||||Treatment comparison for nocturnal hypoglycemic episodes. Nocturnal hypoglycemic episodes are rounded off to 2 decimal places.|Negative binomial regression model|||||||0.008
72549122|NCT01644500|144628100|SUPERIORITY_OR_OTHER_LEGACY|||||||0.006||||||Treatment comparison for nocturnal hypoglycemic episodes. Nocturnal hypoglycemic episodes are rounded off to 2 decimal places.|Negative binomial regression model|||||||0.006
72549123|NCT01644500|144628101|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Fisher Exact|||||||<0.001
72549124|NCT01644500|144628101|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Fisher Exact|||||||<0.001
72549125|NCT01644500|144628102|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|17.41|||<|0.001|TWO_SIDED|95.0|11.27|23.55|||ANCOVA|||Insulin HOMA2-%B||23.55|11.27|<0.001
72549126|NCT01644500|144628102|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|7.92||||0.012|TWO_SIDED|95.0|1.78|14.06|||ANCOVA|||Insulin HOMA2%B||14.06|1.78|0.012
72549127|NCT01644500|144628102|SUPERIORITY||Mean Difference (Net)|16.44|||<|0.001|TWO_SIDED|95.0|11.81|21.06|||ANCOVA|||C-Peptide-Based HOMA2-%B||21.06|11.81|<0.001
72549128|NCT01644500|144628102|SUPERIORITY||Mean Difference (Net)|9.99|||<|0.001|TWO_SIDED|95.0|5.36|14.62|||ANCOVA|||C-Peptide-Based HOMA2-%B||14.62|5.36|<0.001
72549129|NCT01644500|144628103|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.34||||0.913|TWO_SIDED|95.0|-5.83|6.51|||ANCOVA|||Insulin-Based HOMA2%S||6.51|-5.83|0.913
72549130|NCT01644500|144628103|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-3.14||||0.318|TWO_SIDED|95.0|-9.3|3.03|||ANCOVA|||Insulin-Based HOMA2%S||3.03|-9.30|0.318
72549131|NCT01644500|144628103|SUPERIORITY||Mean Difference (Net)|-1.39||||0.576|TWO_SIDED|95.0|-6.27|3.49|||ANCOVA|||C-Peptide-Based HOMA2-%S||3.49|-6.27|0.576
72549132|NCT01644500|144628103|SUPERIORITY||Mean Difference (Net)|-6.79||||0.007|TWO_SIDED|95.0|-11.68|-1.89|||ANCOVA|||C-Peptide-Based HOMA2-%S||-1.89|-11.68|0.007
72549133|NCT01644500|144628106|SUPERIORITY_OR_OTHER_LEGACY|||||||0.18||||||Treatment comparison for SBP.|Mixed Models Analysis|||||||0.180
72549134|NCT01644500|144628106|SUPERIORITY_OR_OTHER_LEGACY|||||||0.245||||||Treatment comparison for SBP.|Mixed Models Analysis|||||||0.245
72549135|NCT01644500|144628106|SUPERIORITY_OR_OTHER_LEGACY|||||||0.717||||||Treatment comparison for DBP.|Mixed Models Analysis|||||||0.717
72549136|NCT01644500|144628106|SUPERIORITY_OR_OTHER_LEGACY|||||||0.619||||||Treatment comparison for DBP.|Mixed Models Analysis|||||||0.619
72549137|NCT01644500|144628107|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
72549138|NCT01644500|144628107|SUPERIORITY_OR_OTHER_LEGACY|||||||0.035|||||||Mixed Models Analysis|||||||0.035
72549139|NCT01644500|144628110|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
72582655|NCT01217112|144695758|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.09|STANDARD_ERROR_OF_MEAN|0.105||0.418|TWO_SIDED|90.0|-0.09|0.26|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.26|-0.09|0.418
72549140|NCT01644500|144628110|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
72549141|NCT01644500|144628111|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
72549142|NCT01644500|144628111|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
72549143|NCT04084483|144628182|SUPERIORITY|||||||0.2175|||||||ANCOVA|||||||0.2175
72549144|NCT04084483|144628183|SUPERIORITY|||||||0.3852|||||||ANCOVA|||||||0.3852
72549145|NCT04084483|144628184|SUPERIORITY|||||||0.298|||||||ANCOVA|||||||0.2980
72549146|NCT04084483|144628185|SUPERIORITY|||||||0.0634|||||||ANCOVA|||||||0.0634
72549147|NCT04084483|144628186|SUPERIORITY|||||||0.7388|||||||ANCOVA|||Corneal Sum||||0.7388
72549148|NCT04084483|144628186|SUPERIORITY|||||||0.3717|||||||ANCOVA|||Corneal Sum||||0.3717
72549149|NCT04084483|144628186|SUPERIORITY|||||||0.3164|||||||ANCOVA|||Conjunctival Sum||||0.3164
72549150|NCT04084483|144628186|SUPERIORITY|||||||0.1953|||||||ANCOVA|||Conjunctival Sum||||0.1953
72549151|NCT04084483|144628186|SUPERIORITY|||||||0.4645|||||||ANCOVA|||Total Eye Sum||||0.4645
72549152|NCT04084483|144628186|SUPERIORITY|||||||0.2135|||||||ANCOVA|||Total Eye Sum||||0.2135
72549153|NCT04084483|144628187|SUPERIORITY|||||||0.599|||||||ANCOVA|||||||0.5990
72549154|NCT04084483|144628187|SUPERIORITY|||||||0.2122|||||||ANCOVA|||||||0.2122
72549155|NCT04084483|144628188|SUPERIORITY|||||||0.9146|||||||ANCOVA|||||||0.9146
72549156|NCT04084483|144628188|SUPERIORITY|||||||0.8494|||||||ANCOVA|||||||0.8494
72549157|NCT04084483|144628189|SUPERIORITY|||||||0.4747|||||||ANCOVA|||||||0.4747
72549158|NCT04084483|144628189|SUPERIORITY|||||||0.5619|||||||ANCOVA|||||||0.5619
72549159|NCT04084483|144628190|SUPERIORITY|||||||0.5985|||||||ANCOVA|||||||0.5985
72549160|NCT04084483|144628190|SUPERIORITY|||||||0.7626|||||||ANCOVA|||||||0.7626
72549161|NCT04084483|144628191|SUPERIORITY|||||||0.833|||||||ANCOVA|||||||0.8330
72549162|NCT04084483|144628191|SUPERIORITY|||||||0.2777|||||||ANCOVA|||||||0.2777
72549163|NCT04084483|144628192|SUPERIORITY|||||||0.9829|||||||ANCOVA|||||||0.9829
72549164|NCT04084483|144628192|SUPERIORITY|||||||0.8675|||||||ANCOVA|||||||0.8675
72549165|NCT04084483|144628193|SUPERIORITY|||||||0.5836|||||||ANCOVA|||||||0.5836
72549166|NCT04084483|144628193|SUPERIORITY|||||||0.2352|||||||ANCOVA|||||||0.2352
72549167|NCT04084483|144628194|SUPERIORITY|||||||0.7367|||||||ANCOVA|||Ocular Discomfort||||0.7367
72549168|NCT04084483|144628194|SUPERIORITY|||||||0.3865|||||||ANCOVA|||Ocular Discomfort||||0.3865
72549169|NCT04084483|144628194|SUPERIORITY|||||||0.8796|||||||ANCOVA|||Burning||||0.8796
72549170|NCT04084483|144628194|SUPERIORITY|||||||0.3515|||||||ANCOVA|||Burning||||0.3515
72549171|NCT04084483|144628194|SUPERIORITY|||||||0.6338|||||||ANCOVA|||Dryness||||0.6338
72549172|NCT04084483|144628194|SUPERIORITY|||||||0.4685|||||||ANCOVA|||Dryness||||0.4685
72549173|NCT04084483|144628194|SUPERIORITY|||||||0.4757|||||||ANCOVA|||Grittiness||||0.4757
72549174|NCT04084483|144628194|SUPERIORITY|||||||0.8803|||||||ANCOVA|||Grittiness||||0.8803
72549175|NCT04084483|144628194|SUPERIORITY|||||||0.8529|||||||ANCOVA|||Stinging||||0.8529
72549176|NCT04084483|144628194|SUPERIORITY|||||||0.7713|||||||ANCOVA|||Stinging||||0.7713
72549177|NCT04084483|144628195|SUPERIORITY|||||||0.138|||||||ANCOVA|||Burning/Stinging||||0.1380
72549178|NCT04084483|144628195|SUPERIORITY|||||||0.3334|||||||ANCOVA|||Burning/Stinging||||0.3334
72549179|NCT04084483|144628195|SUPERIORITY|||||||0.1008|||||||ANCOVA|||Itching||||0.1008
72549180|NCT04084483|144628195|SUPERIORITY|||||||0.4582|||||||ANCOVA|||Itching||||0.4582
72549181|NCT04084483|144628195|SUPERIORITY|||||||0.1511|||||||ANCOVA|||Foreign Body Sensation||||0.1511
72549182|NCT04084483|144628195|SUPERIORITY|||||||0.2555|||||||ANCOVA|||Foreign Body Sensation||||0.2555
72549183|NCT04084483|144628195|SUPERIORITY|||||||0.1546|||||||ANCOVA|||Blurry Vision||||0.1546
72549184|NCT04084483|144628195|SUPERIORITY|||||||0.0495|||||||ANCOVA|||Blurry Vision||||0.0495
72582656|NCT01217112|144695758|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.13|STANDARD_ERROR_OF_MEAN|0.111||0.236|TWO_SIDED|90.0|-0.05|0.32|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.32|-0.05|0.236
72549185|NCT04084483|144628195|SUPERIORITY|||||||0.5791|||||||ANCOVA|||Eye Dryness||||0.5791
72549186|NCT04084483|144628195|SUPERIORITY|||||||0.0736|||||||ANCOVA|||Eye Dryness||||0.0736
72549187|NCT04084483|144628195|SUPERIORITY|||||||0.3666|||||||ANCOVA|||Photophobia||||0.3666
72549188|NCT04084483|144628195|SUPERIORITY|||||||0.039|||||||ANCOVA|||Photophobia||||0.0390
72549189|NCT04084483|144628195|SUPERIORITY|||||||0.0655|||||||ANCOVA|||Pain||||0.0655
72549190|NCT04084483|144628195|SUPERIORITY|||||||0.1947|||||||ANCOVA|||Pain||||0.1947
72549191|NCT04084483|144628196|SUPERIORITY|||||||0.9274|||||||ANCOVA|||||||0.9274
72549192|NCT04084483|144628196|SUPERIORITY|||||||0.0888|||||||ANCOVA|||||||0.0888
72549193|NCT01458405|144628199|SUPERIORITY|||||||0.6453||||||Repeated measures multivariable linear regression with Baseline as a covariate and unstructured covariance.|Regression, Linear|||||||0.6453
72549194|NCT02194998|144628222|SUPERIORITY|A one-sided exact binomial test was used against a null rate of 70% at a significance level of 5%.|||||<|0.01||||||No adjustments for multiple comparisons.|One-Sided Exact Binomial Test|||Null Hypothesis: Cohort A's SVR12 rate \<= 70%.||||<0.01
72549195|NCT02194998|144628222|SUPERIORITY|A one-sided exact binomial test was used against a null rate of 70% at a significance level of 5%.||||||0.47||||||No adjustments for multiple comparisons.|One-Sided Exact Binomial Test|||Null Hypothesis: Cohort B's SVR12 rate \<= 70%.||||0.47
72549196|NCT02194998|144628222|SUPERIORITY|A one-sided exact binomial test was used against a null rate of 70% at a significance level of 5%.|||||<|0.01||||||No adjustments for multiple comparisons.|One-Sided Exact Binomial Test|||Null Hypothesis: Cohort C's SVR12 rate \<= 70%.||||<0.01
72549197|NCT02194998|144628222|SUPERIORITY|A one-sided exact binomial test was used against a null rate of 70% at a significance level of 5%.||||||0.24||||||No adjustments for multiple comparisons.|One-Sided Exact Binomial Test|||Null Hypothesis: Cohort D's SVR12 rate \<= 70%.||||0.24
72549198|NCT02194998|144628235|SUPERIORITY|A one-sided exact binomial test was used against a null rate of 70% at a significance level of 5%.|||||<|0.01||||||No adjustments for multiple comparisons.|One-Sided Exact Binomial Test|||Null Hypothesis: Cohort A's SVR24 rate \<= 70%.||||<0.01
72549199|NCT02194998|144628235|SUPERIORITY|A one-sided exact binomial test was used against a null rate of 70% at a significance level of 5%.||||||0.47||||||No adjustments for multiple comparisons.|One-Sided Exact Binomial Test|||Null Hypothesis: Cohort B's SVR24 rate \<= 70%.||||0.47
72549200|NCT02194998|144628235|SUPERIORITY|A one-sided exact binomial test was used against a null rate of 70% at a significance level of 5%.|||||<|0.01||||||No adjustments for multiple comparisons.|One-Sided Exact Binomial Test|||Null Hypothesis: Cohort C's SVR24 rate \<= 70%.||||<0.01
72549201|NCT02194998|144628235|SUPERIORITY|A one-sided exact binomial test was used against a null rate of 70% at a significance level of 5%.||||||0.24||||||No adjustments for multiple comparisons.|One-Sided Exact Binomial Test|||Null Hypothesis: Cohort D's SVR24 rate \<= 70%.||||0.24
72549202|NCT01890915|144628311|SUPERIORITY_OR_OTHER|||||||0.0001|TWO_SIDED||||||ANOVA|||"Due to impaired thermoregulatory mechanisms secondary to spinal cord injury, subjects with tetraplegia were hypothesized to have a significant rise in core temperature after exposure to warm ambient temperatures, while control subjects were hypothesized to maintain constant core temperature.~Percent change in core temperature of subjects in each group were compared to determine if they were significantly different from baseline to warm exposure."||||0.0001
72549203|NCT01890915|144628312|SUPERIORITY_OR_OTHER|||||||0.006|TWO_SIDED||||||ANOVA|||We hypothesized that subjects with tetraplegia would demonstrate a change in cognitive performance after heat exposure if they had demonstrated a significant increase in core body temperature - as was hypothesized in our primary hypothesis. Cognitive performance was measured, in part, by Interference T-scores derived from the Stroop Color and Word Test.||||0.006
72549204|NCT01890915|144628313|SUPERIORITY_OR_OTHER|||||||0.015|TWO_SIDED||||||ANOVA|||Due to impaired thermoregulatory mechanisms, subjects with tetraplegia were hypothesized to have diminished increases in sweat rate in comparison to controls after heat exposure.||||0.015
72549205|NCT03552757|144628322|SUPERIORITY||Treatment difference|-6.21|||<|0.0001|TWO_SIDED|95.0|-7.28|-5.15|||ANCOVA|||Results are based on the data from in-trial observation period. Week 68 responses were analysed using an analysis of covariance model (ANCOVA) with randomised treatment, stratification groups (oral anti-diabetic (OAD) treatment status and HbA1c category at screening) and the interaction between stratification groups as factors and baseline body weight as covariate.||-5.15|-7.28|<0.0001
72549206|NCT03552757|144628322|SUPERIORITY||Treatment difference|-7.57|||<|0.0001|TWO_SIDED|95.0|-8.56|-6.58|||MMRM|||Results are based on the data from on-treatment observation period. All responses prior to first discontinuation of treatment (or initiation of other anti-obesity medication or bariatric surgery) were included in a mixed model for repeated measurements (MMRM) with randomised treatment, stratification groups (OAD treatment status and HbA1c category at screening) and the interaction between stratification groups as factors and baseline body weight as covariate, all nested within visit.||-6.58|-8.56|<0.0001
72549207|NCT03552757|144628323|SUPERIORITY||Odds Ratio (OR)|4.88|||<|0.0001|TWO_SIDED|95.0|3.58|6.64|||Regression, Logistic|||Results are based on the data from in-trial observation period. Week 68 responses were analysed using a binary logistic regression model with randomised treatment, stratification groups (OAD treatment status and HbA1c category at screening) and the interaction between stratification groups as factors and baseline body weight as covariate.||6.64|3.58|<0.0001
72549208|NCT03552757|144628323|SUPERIORITY||Odds Ratio (OR)|8.69|||<|0.0001|TWO_SIDED|95.0|6.31|11.97|||Regression, Logistic|||Results are based on the data from on-treatment observation period. All responses prior to first discontinuation of treatment (or initiation of other anti-obesity medication or bariatric surgery) were included in a MMRM with randomised treatment, stratification groups (OAD treatment status and HbA1c category at screening) and the interaction between stratification groups as factors and baseline body weight as covariate, all nested within visit.||11.97|6.31|<0.0001
72549209|NCT02674334|144628364|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.16|STANDARD_ERROR_OF_MEAN|0.83||0.165|TWO_SIDED|95.0|-0.49|2.82||P-values were not adjusted for multiple inferences|ANOVA|Continuous responses were tested using RCB ANOVA.||||2.82|-.49|0.165
72549210|NCT02660242|144628375|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|Mixed model w/ repeated measures to account for correlation from cross-over design and multiple measures, adjusting for baseline glucose and period.||The mini-dose glucagon (MDG) condition was compared with each of the conditions. In the event that exercise was terminated early due to glucose \<70 mg/dL and the participant was treated for hypoglycemia (or if participant was treated for hypoglycemia during early recovery \[prior to the meal\]), the nadir glucose value was carried forward through the end of early recovery.||||<0.001
72549211|NCT02660242|144628376|OTHER|||||||0.99|||||||Mixed Models Analysis|Adjusted for subject effect, exercise session, and baseline blood glucose||||||0.99
72549212|NCT02660242|144628377|SUPERIORITY|||||||0.15|||||||Mixed Models Analysis|Adjusted for subject effect, exercise session, and baseline blood glucose||||||0.15
72549213|NCT02660242|144628378|SUPERIORITY|||||||0.99|||||||Mixed Models Analysis|Accounted for correlation due to cross-over design and adjusted for exercise session||||||0.99
72549214|NCT02660242|144628379|SUPERIORITY|||||||0.43|||||||Mixed Models Analysis|Accounted for correlation due to cross-over design and adjusted for exercise session||||||0.43
72549215|NCT02660242|144628380|SUPERIORITY|||||||0.16|||||||Mixed Models Analysis|Accounted for correlation due to cross-over design and adjusted for exercise session||||||0.16
72549216|NCT02660242|144628381|SUPERIORITY|||||||0.69|||||||Mixed Models Analysis|Accounted for correlation due to cross-over design and adjusted for exercise session||||||0.69
72549217|NCT02660242|144628382|SUPERIORITY|||||||0.67|||||||Mixed Models Analysis|Accounted for correlation due to cross-over design and adjusted for exercise session||||||0.67
72549218|NCT02660242|144628383|SUPERIORITY|||||||0.84|||||||Mixed Models Analysis|Accounted for correlation due to cross-over design and adjusted for exercise session||||||0.84
72549219|NCT02660242|144628384|SUPERIORITY|||||||0.63|||||||Mixed Models Analysis|Accounted for correlation due to cross-over design and adjusted for exercise session||||||0.63
72549220|NCT02660242|144628385|SUPERIORITY|||||||0.24|||||||Mixed Models Analysis|Accounted for correlation due to cross-over design and adjusted for exercise session||||||0.24
72549221|NCT02660242|144628386|SUPERIORITY|||||||0.26|||||||Mixed Models Analysis|Accounted for correlation due to cross-over design and adjusted for exercise session||||||0.26
72582657|NCT01217112|144695758|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.06|STANDARD_ERROR_OF_MEAN|0.103||0.556|TWO_SIDED|90.0|-0.11|0.23|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.23|-0.11|0.556
72549222|NCT00982553|144628390|SUPERIORITY||Geometric mean ratios|0.79|||||TWO_SIDED|95.0|0.62|1.0||||||||1.00|0.62|
72549223|NCT00982553|144628391|SUPERIORITY||Geometric mean ratios|1.16|||||TWO_SIDED|95.0|0.73|1.86||||||||1.86|0.73|
72549224|NCT00982553|144628392|SUPERIORITY||Geometric mean ratios|1.01|||||TWO_SIDED|95.0|0.87|1.18||||||||1.18|0.87|
72549225|NCT00982553|144628393|SUPERIORITY||Geometric mean ratios|0.82|||||TWO_SIDED|95.0|0.36|1.85||||||||1.85|0.36|
72549226|NCT01345019|144628394|NON_INFERIORITY|A two-stage approach was used for the non-inferiority test. First, the fixed margin approach was used to ensure denosumab has an effect greater than placebo (ie, the non-inferiority margin M1, ie, the lower bound of the two-sided 95% confidence interval 1.28, is ruled out). Next, a synthesis method was used for the non-inferiority test of the hypothesis that denosumab preserved at least 50% of the effect of zoledronic acid (HR \[95% CI\] of 1.48 \[1.28, 1.71\] for placebo vs zoledronic acid.|Hazard Ratio (HR)|0.98||||0.01|TWO_SIDED|95.0|0.85|1.14|||Cox proportional hazards model|Based on a Cox proportional hazards model stratified by the randomization stratification factors.|A hazard ratio (denosumab:zoledronic acid) \< 1 favors denosumab|||1.14|0.85|0.010
72549227|NCT01345019|144628397|SUPERIORITY|The statistical inferences of the treatment effect on secondary efficacy endpoints (time to the first on study SRE \[superiority\] and time to first and subsequent on study SRE \[superiority, multiple event analysis\]) were to be conducted if denosumab was determined to be non-inferior to zoledronic acid. To control the overall type I error for multiple comparisons at a significant level of 0.05, these secondary efficacy endpoints were tested simultaneously using the Hochberg procedure.||||||0.82|||||||Log Rank|Based on a log rank test stratified by randomization stratification factors.||||||0.82
72549228|NCT01345019|144628398|SUPERIORITY|The statistical inferences of the treatment effect on secondary efficacy endpoints (time to the first on study SRE \[superiority\] and time to first and subsequent on study SRE \[superiority, multiple event analysis\]) were to be conducted if denosumab was determined to be non-inferior to zoledronic acid. To control the overall type I error for multiple comparisons at a significant level of 0.05, these secondary efficacy endpoints were tested simultaneously using the Hochberg procedure.|Rate ratio|1.01||||0.84|TWO_SIDED|95.0|0.89|1.15|||Andersen-Gill model|Based on an Andersen-Gill model stratified by the randomization stratification factors.|A rate ratio (denosumab:zoledronic acid) \< 1 favors denosumab.|||1.15|0.89|0.84
72549229|NCT01345019|144628400|SUPERIORITY|If superiority of denosumab over zoledronic acid was established for both time to first SRE and time to first and subsequent SRE, the additional secondary endpoint (overall survival) was to be tested at a significance level of 0.05.|Hazard Ratio (HR)|0.9||||0.41|TWO_SIDED|95.0|0.7|1.16|||Cox proportional hazards model||A hazard ratio (denosumab:zoledronic acid) \< 1 favors denosumab.|The survival function of time to death for each treatment group was estimated using Kaplan-Meier method and the hazard ratio of denosumab compared with zoledronic acid and its 2-sided 95% CI were estimated using a Cox proportional hazards model stratified by the randomization stratification factors and including treatment groups, age, race group, geographic region, baseline creatinine clearance, baseline risk per cytogenetic based prognosis, and baseline ECOG as independent variables.||1.16|0.70|0.41
72582658|NCT01217112|144695759|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.24|STANDARD_ERROR_OF_MEAN|0.241||0.329|TWO_SIDED|90.0|-0.64|0.17|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.17|-0.64|0.329
72549230|NCT00235456|144628402|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.61||||0.04|TWO_SIDED|95.0|0.38|0.98|||Chi-squared|||||0.98|0.38|0.04
72549231|NCT00235456|144628403|SUPERIORITY_OR_OTHER|||||||0.54|||||||t-test, 2 sided|||||||0.54
72549232|NCT00235456|144628404|SUPERIORITY_OR_OTHER|||||||0.28|||||||t-test, 2 sided|||||||0.28
72549233|NCT00235456|144628405|SUPERIORITY_OR_OTHER|||||||0.57|||||||t-test, 2 sided|||||||0.57
72549234|NCT00235456|144628406|SUPERIORITY_OR_OTHER|||||||0.71|||||||t-test, 2 sided|||||||0.71
72549235|NCT00235456|144628407|SUPERIORITY_OR_OTHER|||||||0.09|||||||t-test, 2 sided|||||||0.09
72549236|NCT00386009|144628408|SUPERIORITY_OR_OTHER|||||||0.068||95.0||||P-value for Change from Baseline to 12 Week Endpoint. Change = Endpoint minus baseline.|ANOVA|||||||0.068
72549237|NCT00386009|144628409|SUPERIORITY_OR_OTHER|||||||0.626||95.0||||P-value for Change from Baseline to 12 Week Endpoint. Change = Endpoint minus baseline.|ANOVA|||||||0.626
72582659|NCT01217112|144695759|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.28|STANDARD_ERROR_OF_MEAN|0.236||0.232|TWO_SIDED|90.0|-0.11|0.68|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.68|-0.11|0.232
72582660|NCT01217112|144695759|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.31|STANDARD_ERROR_OF_MEAN|0.222||0.164|TWO_SIDED|90.0|-0.06|0.68|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.68|-0.06|0.164
72549238|NCT00386009|144628410|SUPERIORITY_OR_OTHER|||||||0.113||95.0||||P-value for Change from Baseline to 12 Week Endpoint. Change = Endpoint minus baseline.|ANOVA|||||||0.113
72549239|NCT00386009|144628411|SUPERIORITY_OR_OTHER|||||||0.837||95.0||||P-value for Change from Baseline to 12 Week Endpoint. Change = Endpoint minus baseline.|ANOVA|||||||0.837
72549240|NCT00386009|144628412|SUPERIORITY_OR_OTHER|||||||0.4||95.0||||P-value for Change from Baseline to 12 Week Endpoint. Change = Endpoint minus baseline.|ANOVA|||||||0.400
72549241|NCT00386009|144628413|SUPERIORITY_OR_OTHER|||||||0.864||95.0||||P-value for Change from Baseline to 12 Week Endpoint. Change = Endpoint minus baseline.|ANOVA|||||||0.864
72549242|NCT00386009|144628414|SUPERIORITY_OR_OTHER|||||||0.34||95.0||||P-value for Change from Baseline to 12 Week Endpoint. Change = Endpoint minus baseline.|ANOVA|||||||0.340
72549243|NCT00386009|144628415|SUPERIORITY_OR_OTHER|||||||0.838||95.0||||P-value for Change from Baseline to 12 Week Endpoint. Change = Endpoint minus baseline.|ANOVA|||||||0.838
72549244|NCT00386009|144628416|SUPERIORITY_OR_OTHER|||||||0.609||95.0||||P-value for Change from Baseline to 12 Week Endpoint. Change = Endpoint minus baseline.|ANOVA|||||||0.609
72582661|NCT01217112|144695759|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.24|STANDARD_ERROR_OF_MEAN|0.232||0.302|TWO_SIDED|90.0|-0.15|0.63|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.63|-0.15|0.302
72582662|NCT01217112|144695760|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.12|STANDARD_ERROR_OF_MEAN|0.231||0.614|TWO_SIDED|90.0|-0.5|0.27|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.27|-0.50|0.614
72582663|NCT01217112|144695760|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.227||0.669|TWO_SIDED|90.0|-0.28|0.48|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.48|-0.28|0.669
72549245|NCT00386009|144628417|SUPERIORITY_OR_OTHER|||||||0.427||95.0||||P-value for Change from Baseline to 12 Week Endpoint. Change = Endpoint minus baseline.|ANOVA|||||||0.427
72549246|NCT00386009|144628418|SUPERIORITY_OR_OTHER|||||||0.838||95.0||||P-value for Change from Baseline to 12 Week Endpoint. Change = Endpoint minus baseline.|ANOVA|||||||0.838
72549247|NCT00386009|144628419|SUPERIORITY_OR_OTHER|||||||0.09||95.0||||P-value for Change from Baseline to 12 Week Endpoint. Change = Endpoint minus baseline.|ANOVA|||||||0.090
72549248|NCT00386009|144628420|SUPERIORITY_OR_OTHER|||||||0.113||95.0||||P-value for Change from Baseline to 12 Week Endpoint. Change = Endpoint minus baseline.|ANOVA|||||||0.113
72549249|NCT00386009|144628423|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Change from Baseline to 12 Week Endpoint. Change = Endpoint minus baseline.|ANOVA|||||||<0.001
72549250|NCT02933866|144628441|SUPERIORITY|||||||0.2961|||||||Cochran-Mantel-Haenszel|||||||0.2961
72549251|NCT04646109|144628465|SUPERIORITY|||||||0.43||||||A p\<0.05 value was considered statistically significant|Chi-squared|||||||0.43
72549252|NCT04646109|144628466|SUPERIORITY|||||||0.14||||||A p\<0.05 value was considered statistically significant|Wilcoxon (Mann-Whitney)|||||||0.14
72549253|NCT04646109|144628467|SUPERIORITY|||||||0.68||||||A p\<0.05 value was considered statistically significant|Wilcoxon (Mann-Whitney)|||||||0.68
72549254|NCT04646109|144628468|SUPERIORITY|||||||0.15||||||A p\<0.05 value was considered statistically significant|Wilcoxon (Mann-Whitney)|||||||0.15
72549255|NCT04646109|144628469|SUPERIORITY|||||||0.37||||||A p\<0.05 value was considered statistically significant|Wilcoxon (Mann-Whitney)|||||||0.37
72549256|NCT04646109|144628470|SUPERIORITY|||||||0.12||||||A p\<0.05 value was considered statistically significant|Wilcoxon (Mann-Whitney)|||||||0.12
72549257|NCT04646109|144628471|SUPERIORITY|||||||0.22||||||A p\<0.05 value was considered statistically significant|Wilcoxon (Mann-Whitney)|||||||0.22
72549258|NCT04646109|144628474|SUPERIORITY|||||||0.1||||||A p\<0.05 value was considered statistically significant|Chi-squared|||||||0.10
72549259|NCT04646109|144628475|SUPERIORITY|||||||0.37||||||A p\<0.05 value was considered statistically significant|Chi-squared|||||||0.37
72549260|NCT04646109|144628476|SUPERIORITY|||||||0.03||||||A p\<0.05 value was considered statistically significant|Wilcoxon (Mann-Whitney)|||||||0.03
72549261|NCT04646109|144628477|SUPERIORITY|||||||0.39||||||A p\<0.05 value was considered statistically significant|Wilcoxon (Mann-Whitney)|||||||0.39
72549262|NCT04646109|144628478|SUPERIORITY|||||||0.24||||||A p\<0.05 value was considered statistically significant|Wilcoxon (Mann-Whitney)|||||||0.24
72549263|NCT04646109|144628479|SUPERIORITY|||||||0.56||||||A p\<0.05 value was considered statistically significant|Wilcoxon (Mann-Whitney)|||||||0.56
72549264|NCT04646109|144628480|SUPERIORITY|||||||0.005||||||A p\<0.05 value was considered statistically significant|Wilcoxon (Mann-Whitney)|||||||0.005
72549265|NCT04646109|144628481|SUPERIORITY|||||||0.03||||||A p\<0.05 value was considered statistically significant|Wilcoxon (Mann-Whitney)|||||||0.03
72582664|NCT01217112|144695760|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.12|STANDARD_ERROR_OF_MEAN|0.24||0.621|TWO_SIDED|90.0|-0.28|0.52|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.52|-0.28|0.621
72582665|NCT01217112|144695760|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.04|STANDARD_ERROR_OF_MEAN|0.222||0.867|TWO_SIDED|90.0|-0.33|0.41|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.41|-0.33|0.867
72582666|NCT01217112|144695761|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.55|STANDARD_ERROR_OF_MEAN|2.624||0.335|TWO_SIDED|90.0|-1.84|6.95|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||6.95|-1.84|0.335
72582667|NCT01217112|144695761|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.36|STANDARD_ERROR_OF_MEAN|2.545||0.358|TWO_SIDED|90.0|-1.9|6.62|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||6.62|-1.90|0.358
72549266|NCT04646109|144628482|SUPERIORITY|||||||0.01||||||A p\<0.05 value was considered statistically significant|Chi-squared|||||||0.01
72549267|NCT00577460|144628485|SUPERIORITY_OR_OTHER|||||||0.0039||95.0|||||ANCOVA|Analysis of covariance (ANCOVA) with factors treatment and country and covariate OL baseline||PPX ER versus Placebo||||0.0039
72412702|NCT00489970|144333468|NON_INFERIORITY|One month after vaccination, the lower limit of the 97.5% CI for the difference between groups in the booster response rate \[a second dose of Boostrix (Adacel group) minus the first dose of Boostrix (Control group)\] against diphtheria antigen was greater than or equal to -10% (clinical limit for non-inferiority).|Difference in booster response rate|-8.56|||||TWO_SIDED|97.5|-20.33|2.73|||||Standardized asymptotic 97.5% CI for the group difference in the Booster response was calculated.|To demonstrate that the immune response elicited by a second dose of Boostrix vaccine (Adacel group) was non-inferior to the immune response elicited by a first dose of Boostrix vaccine (Control group), with respect to booster response against diphtheria antigen, one month following vaccination.||2.73|-20.33|
72549268|NCT00577460|144628485|SUPERIORITY_OR_OTHER|||||||0.0001||95.0|||||ANCOVA|Analysis of covariance (ANCOVA) with factors treatment and country and covariate OL baseline||PPX IR versus Placebo||||0.0001
72549269|NCT00577460|144628488|SUPERIORITY_OR_OTHER|||||||0.559||95.0|||||ANCOVA|Analysis of covariance with factors for treatment, country and baseline as a covariate||||||0.5590
72549270|NCT00577460|144628488|SUPERIORITY_OR_OTHER|||||||0.1289||95.0|||||ANCOVA|Analysis of covariance with factors for treatment, country and baseline as a covariate||||||0.1289
72549271|NCT00577460|144628490|SUPERIORITY_OR_OTHER|||||||0.1073||95.0|||||ANCOVA|Analysis of covariance with factors for treatment, country and baseline as a covariate||||||0.1073
72549272|NCT00577460|144628490|SUPERIORITY_OR_OTHER|||||||0.8694||95.0|||||ANCOVA|Analysis of covariance with factors for treatment, country and baseline as a covariate||||||0.8694
72549273|NCT00577460|144628491|SUPERIORITY_OR_OTHER|||||||0.0009||95.0|||||ANCOVA|Analysis of covariance with factors for treatment, country and baseline as a covariate||||||0.0009
72549274|NCT00577460|144628491|SUPERIORITY_OR_OTHER|||||||0.0573||95.0|||||ANCOVA|Analysis of covariance with factors for treatment, country and baseline as a covariate||||||0.0573
72549275|NCT00577460|144628492|SUPERIORITY_OR_OTHER|||||||0.6434||95.0|||||ANCOVA|Analysis of covariance with factors for treatment, country and baseline as a covariate||||||0.6434
72549276|NCT00577460|144628492|SUPERIORITY_OR_OTHER|||||||0.2469||95.0|||||ANCOVA|Analysis of covariance with factors for treatment, country and baseline as a covariate||||||0.2469
72549277|NCT00577460|144628493|SUPERIORITY_OR_OTHER|||||||0.9741||95.0|||||ANCOVA|Analysis of covariance with factors for treatment, country and baseline as a covariate||||||0.9741
72549278|NCT00577460|144628493|SUPERIORITY_OR_OTHER|||||||0.762||95.0|||||ANCOVA|Analysis of covariance with factors for treatment, country and baseline as a covariate||||||0.7620
72549279|NCT00577460|144628497|SUPERIORITY_OR_OTHER|||||||0.0831||95.0|||||ANCOVA|Analysis of covariance with factors for treatment, country and baseline as a covariate||||||0.0831
72549280|NCT00577460|144628497|SUPERIORITY_OR_OTHER|||||||0.0759||95.0|||||ANCOVA|Analysis of covariance with factors for treatment, country and baseline as a covariate||||||0.0759
72549281|NCT00577460|144628498|SUPERIORITY_OR_OTHER|||||||0.1713||95.0|||||ANCOVA|Analysis of covariance with factors for treatment, country and baseline as a covariate||||||0.1713
72549282|NCT00577460|144628498|SUPERIORITY_OR_OTHER|||||||0.013||95.0|||||ANCOVA|Analysis of covariance with factors for treatment, country and baseline as a covariate||||||0.0130
72549283|NCT00577460|144628499|SUPERIORITY_OR_OTHER|||||||0.0015||95.0|||||ANCOVA|Analysis of covariance with factors for treatment, country and baseline as a covariate||||||0.0015
72549284|NCT00577460|144628499|SUPERIORITY_OR_OTHER|||||||0.0002||95.0|||||ANCOVA|Analysis of covariance with factors for treatment, country and baseline as a covariate||||||0.0002
72549285|NCT00577460|144628500|SUPERIORITY_OR_OTHER|||||||0.876||95.0|||||ANCOVA|Analysis of covariance with factors for treatment, country and baseline as a covariate||||||0.8760
72549286|NCT00577460|144628500|SUPERIORITY_OR_OTHER|||||||0.5113||95.0|||||ANCOVA|Analysis of covariance with factors for treatment, country and baseline as a covariate||||||0.5113
72549287|NCT00577460|144628501|SUPERIORITY_OR_OTHER|||||||0.0148||95.0|||||ANCOVA|Analysis of covariance with factors for treatment, country and baseline as a covariate||||||0.0148
72549288|NCT00577460|144628501|SUPERIORITY_OR_OTHER|||||||0.0201||95.0|||||ANCOVA|Analysis of covariance with factors for treatment, country and baseline as a covariate||||||0.0201
72549289|NCT00159965|144628545|SUPERIORITY_OR_OTHER||Risk Ratio, log|0.673|STANDARD_ERROR_OF_MEAN|0.369||0.29|TWO_SIDED|95.0|-0.051|1.396|||Overdispersed Poisson Regression|||Between-group seizure change. The primary hypothesis of this pilot randomized control trial (RCT) was to assess the magnitude of seizure frequency reduction by treatment, comparing placbo to sertraline. The alternative hypothesis is that patients treated with sertraline will show a significant decrease in seizures from baseline to exit.||1.396|-0.051|0.29
72549290|NCT00159965|144628545|SUPERIORITY_OR_OTHER||Risk Ratio, log|-0.598|STANDARD_ERROR_OF_MEAN|0.276||0.03|TWO_SIDED|95.0|-1.139|-0.073|||Overdispersed Poisson Regression|||Within-group seizure change. The hypothesis is that patients treated with sertraline will show a significant decrease in seizures from baseline to exit.||-0.073|-1.139|0.03
72549291|NCT00159965|144628545|SUPERIORITY_OR_OTHER||Risk Ratio, log|0.077|STANDARD_ERROR_OF_MEAN|0.252||0.78|TWO_SIDED|95.0|-0.431|0.571|||Overdispersed Poisson Regression|||Within-group seizure change. The hypothesis is that patients treated with placebo will not show a significant decrease in seizures from baseline to exit.||0.571|-0.431|0.78
72549292|NCT00159965|144628546|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||ANCOVA|||||||>0.05
72549293|NCT00159965|144628547|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||ANCOVA|||||||>0.05
72549294|NCT00159965|144628548|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||ANCOVA|||||||>0.05
72549295|NCT00159965|144628549|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||ANCOVA|||||||>0.05
72549296|NCT00159965|144628550|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||ANCOVA|||||||>0.05
72549297|NCT00159965|144628551|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||ANCOVA|||||||>0.05
72549298|NCT00159965|144628552|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||ANCOVA|||||||>0.05
72549299|NCT00159965|144628553|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||ANCOVA|||||||>0.05
72549300|NCT00159965|144628554|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||ANCOVA|||||||>0.05
72549301|NCT00159965|144628555|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||ANCOVA|||||||>0.05
72549302|NCT00159965|144628556|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||ANCOVA|||||||>0.05
72549303|NCT00159965|144628557|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||ANCOVA|||||||>0.05
72549304|NCT00159965|144628558|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||ANCOVA|||||||>0.05
72582668|NCT01217112|144695761|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.3|STANDARD_ERROR_OF_MEAN|2.406||0.9|TWO_SIDED|90.0|-3.72|4.33|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||4.33|-3.72|0.900
72582669|NCT01217112|144695761|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|6.02|STANDARD_ERROR_OF_MEAN|2.486||0.019|TWO_SIDED|90.0|1.86|10.19|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||10.19|1.86|0.019
72582670|NCT01217112|144695762|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.24|STANDARD_ERROR_OF_MEAN|0.245||0.325|TWO_SIDED|90.0|-0.65|0.17|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.17|-0.65|0.325
72582671|NCT01217112|144695762|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.19|STANDARD_ERROR_OF_MEAN|0.238||0.438|TWO_SIDED|90.0|-0.21|0.59|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.59|-0.21|0.438
72582672|NCT01217112|144695762|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.09|STANDARD_ERROR_OF_MEAN|0.226||0.701|TWO_SIDED|90.0|-0.29|0.47|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.47|-0.29|0.701
72582673|NCT01217112|144695762|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.11|STANDARD_ERROR_OF_MEAN|0.232||0.624|TWO_SIDED|90.0|-0.5|0.27|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.27|-0.50|0.624
72582674|NCT01217112|144695763|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.07|STANDARD_ERROR_OF_MEAN|0.058||0.233|TWO_SIDED|90.0|-0.17|0.03|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.03|-0.17|0.233
72582675|NCT01217112|144695763|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.056||0.727|TWO_SIDED|90.0|-0.07|0.11|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.11|-0.07|0.727
72582676|NCT01217112|144695763|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.03|STANDARD_ERROR_OF_MEAN|0.053||0.593|TWO_SIDED|90.0|-0.06|0.12|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.12|-0.06|0.593
72582677|NCT01217112|144695763|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.056||0.075|TWO_SIDED|90.0|-0.2|-0.01|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||-0.01|-0.20|0.075
72549305|NCT02841709|144628616|OTHER||||||<|0.001|||||||Multiple Comparison Procedure-Model|||"Multiple Comparison Procedure-Modeling (MCP-Mod) was used to assess a dose response across placebo and all ACT-541468 doses. The null hypothesis of no dose response was rejected if at least one of the six Multiple Contrasts Tests (MCTs) had a multiplicity adjusted p-value \<0.05. The analysis was performed using the R-package DoseFinding (Bornkamp B, Pinheiro J, Bretz F. Planning and analyzing dose finding experiments. 2016. Available from: cranrprojects.org/web/packages/DoseFinding.)"||||<0.001
72549306|NCT02841709|144628616|OTHER||LS mean difference|-5.4|STANDARD_ERROR_OF_MEAN|4.73||0.258|TWO_SIDED|95.0|-14.7|4.0|||Linear mixed effects model||Parameter Dispersion Type: Standard Error of the LS Mean|||4.0|-14.7|0.258
72549307|NCT02841709|144628616|OTHER||LS mean difference|-18.4|STANDARD_ERROR_OF_MEAN|4.76|<|0.001|TWO_SIDED|95.0|-27.8|-9.0|||Linear mixed effects model||Parameter Dispersion Type: Standard Error of the LS Mean|||-9.0|-27.8|<0.001
72549308|NCT02841709|144628616|OTHER||LS mean difference|-31.5|STANDARD_ERROR_OF_MEAN|4.74|<|0.001|TWO_SIDED|95.0|-40.9|-22.2|||Linear mixed effects model|||||-22.2|-40.9|<0.001
72549309|NCT02841709|144628616|OTHER||LS mean difference|-47.8|STANDARD_ERROR_OF_MEAN|4.74|<|0.001|TWO_SIDED|95.0|-57.2|-38.5|||Linear mixed effects model|||||-38.5|-57.2|<0.001
72549310|NCT00076102|144628625|OTHER|||||||0.0301||||||The reported F statistic and p-value are representative of the difference in the Parent proxy Form and the Child Self-Report Form response for Adaptive Behavior.|ANOVA|||F=5.45 under the null hypothesis||||0.0301
72549311|NCT00076102|144628625|OTHER|||||||0.0186||||||The reported p-value is representative of the difference in the Parent proxy Form and the Child Self-Report Form response for Emotional Functioning.|ANOVA|||F = 6.56 under the null hypothesis||||0.0186
72549312|NCT00076102|144628625|OTHER|||||||0.0032||||||The reported p-value is representative of the difference in the Parent proxy Form and the Child Self-Report Form response for Medical/Physical Status.|ANOVA|||F=11.23 under the null hypothesis||||0.0032
72549313|NCT00076102|144628626|OTHER|||||||0.6263|||||||ANOVA|||F=0.25 under the null hypothesis||||0.6263
72549314|NCT00076102|144628626|OTHER|||||||0.3625|||||||ANOVA|||F= 0.87 under the null hypothesis||||0.3625
72549315|NCT00076102|144628626|OTHER|||||||0.5877|||||||ANOVA|||F=0.31 under the null hypothesis||||0.5877
72549316|NCT00076102|144628626|OTHER|||||||0.2767|||||||ANOVA|||F=1.27 under the null hypothesis||||0.2767
72549317|NCT00076102|144628626|OTHER|||||||0.8466|||||||ANOVA|||F=0.04 under the null hypothesis||||0.8466
72549318|NCT00076102|144628626|OTHER|||||||0.6774|||||||ANOVA|||F=0.18 under the null hypothesis||||0.6774
72549319|NCT02581345|144628640|EQUIVALENCE|Per Food and Drug Administration (FDA), the equivalence testing was made using 90% confidence interval and an equivalence margin of 18%|Difference in proportion (M923 - EU RPP)|0.014|||||TWO_SIDED|90.0|-0.043|0.072||||||||0.072|-0.043|
72549320|NCT02581345|144628640|EQUIVALENCE|Per European Medicines Agency (EMA), the equivalence testing was made using 95% confidence interval and an equivalence margin of 15%|Difference in proportion (M923 - EU RPP)|0.014|||||TWO_SIDED|95.0|-0.054|0.082||||||||0.082|-0.054|
72549321|NCT02581345|144628641|OTHER|No formal hypothesis testing of equivalence was performed for the comparison between M923 and EU RPP using the secondary efficacy outcome measures. Confidence Interval for difference in proportion in original scale was calculated using stratified Newcombe method.|Difference in proportion (M923 - EU RPP)|0.031|||||TWO_SIDED|95.0|-0.048|0.11||||||||0.110|-0.048|
72549322|NCT02581345|144628642|OTHER|No formal hypothesis testing of equivalence was performed for the comparison between M923 and EU RPP using the secondary efficacy outcome measures. Confidence Interval for difference in proportion in original scale calculated using stratified Newcombe method. Protocol defined margins are: \[-0.18;+0.18\] for 90% confidence interval.|Difference in proportion (M923 - EU RPP)|-0.022|||||TWO_SIDED|90.0|-0.061|0.016||||||||0.016|-0.061|
72549323|NCT02581345|144628642|OTHER|No formal hypothesis testing of equivalence was performed for the comparison between M923 and EU RPP using the secondary efficacy outcome measures. Confidence Interval for difference in proportion in original scale calculated using stratified Newcombe method. Protocol defined margins are: \[-0.15;+0.15\] for 95% confidence interval.|Difference in proportion (M923 - EU RPP)|-0.022|||||TWO_SIDED|95.0|-0.069|0.024||||||||0.024|-0.069|
72549324|NCT02581345|144628645|OTHER|No formal hypothesis testing of equivalence was performed for the comparison between M923 and EU RPP using the secondary efficacy outcome measures. Confidence Interval for difference in proportion in original scale calculated using stratified Newcombe method. Protocol defined margins are: \[-0.18;+0.18\] for 90% confidence interval.|Difference in proportion (M923 - EU RPP)|0.08|||||TWO_SIDED|90.0|0.01|0.149||||||||0.149|0.010|
72549325|NCT02581345|144628645|OTHER|No formal hypothesis testing of equivalence was performed for the comparison between M923 and EU RPP using the secondary efficacy outcome measures. Confidence Interval for difference in proportion in original scale calculated using stratified Newcombe method. Protocol defined margins are:\[-0.15;+0.15\] for 95% confidence interval.|Difference in proportion (M923 - EU RPP)|0.08|||||TWO_SIDED|95.0|-0.004|0.162||||||||0.162|-0.004|
72549326|NCT01244126|144628683|SUPERIORITY_OR_OTHER||Kruskall Wallis ANOVA by ranks|0.21|STANDARD_DEVIATION|3.0||0.21|TWO_SIDED|95.0|||||Kruskal-Wallis|||The primary outcome of the study was the maximum postoperative FLACC pain score.||||0.21
72549327|NCT01244126|144628684|SUPERIORITY_OR_OTHER||Kruskall Wallis ANOVA|0.34||||0.34||95.0|||||Kruskal-Wallis|||Kruskall Wallis test||||0.34
72549328|NCT00863746|144628687|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.9934||||0.4687|TWO_SIDED|95.0|0.8409|1.1735||p-value of one-sided test (significance level 2.5%)|Log Rank|stratified by region, number of prior treatments, presence brain mets at baseline, prior EGFR inhibitor treatment||Test for superiority of Sorafenib over Placebo||1.1735|0.8409|0.4687
72549329|NCT00863746|144628688|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.6068|||<|0.0001|TWO_SIDED|95.0|0.5139|0.7165||p-value of one-sided test (significance level 2.5%)|Log Rank|stratified by region, number of prior treatments, presence brain mets at baseline, prior EGFR inhibitor treatment||Test for superiority of Sorafenib over Placebo||0.7165|0.5139|<0.0001
72549330|NCT00863746|144628689|SUPERIORITY_OR_OTHER||CMH-adjusted difference in proportions|0.2263|||<|1e-06|TWO_SIDED|95.0|0.1575|0.2952|||Cochran-Mantel-Haenszel|stratified by region, number of prior treatments, presence brain mets at baseline, prior EGFR inhibitor treatment||||0.2952|0.1575|<0.000001
72549331|NCT00863746|144628690|SUPERIORITY_OR_OTHER||CMH-adjusted difference in proportions|0.039||||0.000876|TWO_SIDED|95.0|0.0137|0.0642|||Cochran-Mantel-Haenszel|stratified by region, number of prior treatments, presence brain mets at baseline, prior EGFR inhibitor treatment||||0.0642|0.0137|0.000876
72549332|NCT00863746|144628691|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.542|||<|0.0001|TWO_SIDED|95.0|0.4526|0.6492||p-value of one-sided test (significance level 2.5%)|Log Rank|stratified by region, number of prior treatments, presence brain mets at baseline, prior EGFR inhibitor treatment||Test for superiority of Sorafenib over Placebo||0.6492|0.4526|<0.0001
72549333|NCT00863746|144628692|SUPERIORITY_OR_OTHER|||||||0.3121||||||p-value for test of treatment effect equal to 0.|Mixed Models Analysis|||||||0.3121
72549334|NCT00863746|144628693|SUPERIORITY_OR_OTHER|||||||0.2948||||||p-value for test of treatment effect equal to 0|Mixed Models Analysis|||||||0.2948
72549335|NCT00863746|144628694|SUPERIORITY_OR_OTHER|||||||0.8344||||||p-value for test of treatment effect equal to 0|Mixed Models Analysis|||||||0.8344
72549336|NCT00863746|144628695|SUPERIORITY_OR_OTHER|||||||0.1438||||||p-value for test of treatment effect equal to 0.|Mixed Models Analysis|||||||0.1438
72549337|NCT00863746|144628696|SUPERIORITY_OR_OTHER|||||||0.9228||||||p-value for treatment effect equal to 0.|Mixed Models Analysis|||||||0.9228
72549338|NCT00453362|144628697|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.31||||0.017|TWO_SIDED|95.0|0.11|0.87||This comparison is for hypothesis generation, rather than hypothesis testing. Thus the p-value is not adjusted for multiple comparisons, and the interpretation of p-value should be with caution.|Log Rank||The hazard ratio was estimated using a Cox Proportional Hazard Model. The hazard ratio is relative to FDG Non-Responders.|The null hypothesis is that there is no difference in PFS between FDG Responders and FDG Non-Responders. The alternative hypothesis is that FDG Responders would have prolonged PFS compared with FDG Non-Responders.||0.87|0.11|0.017
72549339|NCT00453362|144628699|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.3||||0.076|TWO_SIDED|95.0|0.06|1.42||This comparison is for hypothesis generation, rather than hypothesis testing. Thus the p-value is not adjusted for multiple comparisons, and the interpretation of p-value should be with caution.|Log Rank||The hazard ratio was estimated using a Cox Proportional Hazard Model. The hazard ratio is relative to FDG Progressive Disease.|The null hypothesis is that there is no difference in PFS between FDG Responders and FDG Progressive Disease. The alternative hypothesis is that FDG Responders would have a prolonged PFS compared to FDG Progressive Disease.||1.42|0.06|0.076
72582678|NCT01217112|144695764|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.084||0.236|TWO_SIDED|90.0|-0.04|0.24|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.24|-0.04|0.236
72582679|NCT01217112|144695764|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.082||0.579|TWO_SIDED|90.0|-0.09|0.18|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.18|-0.09|0.579
72582680|NCT01217112|144695764|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.077||0.837|TWO_SIDED|90.0|-0.15|0.11|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.11|-0.15|0.837
72582681|NCT01217112|144695764|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.06|STANDARD_ERROR_OF_MEAN|0.081||0.467|TWO_SIDED|90.0|-0.08|0.19|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.19|-0.08|0.467
72549340|NCT00453362|144628701|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.17||||0.008|TWO_SIDED|95.0|0.04|0.73||This comparison is for hypothesis generation, rather than hypothesis testing. Thus the p-value is not adjusted for multiple comparisons, and the interpretation of p-value should be with caution.|Log Rank||The hazard ratio was estimated using a Cox Proportional Hazard Model. The hazard ratio is relative to FLT Non-Responders.|The null hypothesis is that there is no difference in PFS between FLT Responders and FLT Non-Responders. The alternative hypothesis is that FLT Responders would have prolonged PFS compared with FLT Non-Responders.||0.73|0.04|0.008
72549341|NCT00453362|144628702|SUPERIORITY_OR_OTHER|||||||0.049||95.0||||This comparison is for hypothesis generation, rather than hypothesis testing. Thus the p-value is not adjusted for multiple comparisons, and the interpretation of p-value should be with caution.|Log Rank|||The null hypothesis is that there is no difference between FLT Responders and FLT Progressive Disease. Alternative hypothesis is that FLT responders would have prolonged PFS compared to FLT Progressive Disease.||||0.049
72549342|NCT00453362|144628703|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.36||||0.073|TWO_SIDED|95.0|0.11|1.16||This comparison is for hypothesis generation, rather than hypothesis testing. Thus the p-value is not adjusted for multiple comparisons, and the interpretation of p-value should be with caution.|Log Rank||The hazard ratio was estimated using a Cox Proportional Hazard Model. The hazard ratio is relative to FDG Non-Responders.|The null hypothesis is that there is no difference in OS between FDG Responders and FDG Non-Responders. The alternative hypothesis is that FDG responders would have prolonged OS compared with FDG Non-Responders.||1.16|0.11|0.073
72582682|NCT01217112|144695765|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.38|STANDARD_ERROR_OF_MEAN|0.613||0.533|TWO_SIDED|90.0|-1.41|0.64|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.64|-1.41|0.533
72582683|NCT01217112|144695765|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.15|STANDARD_ERROR_OF_MEAN|0.585||0.804|TWO_SIDED|90.0|-0.84|1.13|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||1.13|-0.84|0.804
72582684|NCT01217112|144695765|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.06|STANDARD_ERROR_OF_MEAN|0.556||0.916|TWO_SIDED|90.0|-0.87|0.99|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.99|-0.87|0.916
72582685|NCT01217112|144695765|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.23|STANDARD_ERROR_OF_MEAN|0.583||0.04|TWO_SIDED|90.0|-2.2|-0.25|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||-0.25|-2.20|0.040
72549343|NCT00453362|144628706|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.67||||0.618|TWO_SIDED|95.0|0.14|3.21||This comparison is for hypothesis generation, rather than hypothesis testing. Thus the p-value is not adjusted for multiple comparisons, and the interpretation of p-value should be with caution.|Log Rank||The hazard ratio was estimated using a Cox Proportional Hazard Model. The hazard ratio is relative to FDG Progressive Disease.|The null hypothesis is that there is no difference in Overall Survival between FDG Responders and FDG Progressive Disease. The alternative hypothesis is that FDG Responders would have prolonged OS compared with FDG Progressive Disease.||3.21|0.14|0.618
72549344|NCT00453362|144628707|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.38||||0.163|TWO_SIDED|95.0|0.09|1.57||This comparison is for hypothesis generation, rather than hypothesis testing. Thus the p-value is not adjusted for multiple comparisons, and the interpretation of p-value should be with caution.|Log Rank||The hazard ratio was estimated using a Cox Proportional Hazard Model. The hazard ratio is relative to FLT Non-Responders.|The null hypothesis is that there is no difference in OS between FLT Responders and FLT Non-Responders. The alternative hypothesis is that FLT Responders would have prolonged OS compared with FLT Non-Responders.||1.57|0.09|0.163
72549345|NCT00453362|144628708|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.35||||0.327|TWO_SIDED|95.0|0.04|3.16||This comparison is for hypothesis generation, rather than hypothesis testing. Thus the p-value is not adjusted for multiple comparisons, and the interpretation of p-value should be with caution.|Log Rank||The hazard ratio was estimated using a Cox Proportional Hazard Model. The hazard ratio is relative to FLT Progressive Disease.|The null hypothesis is that there is no difference in OS between FLT Responders and FLT Progressive Disease. The alternative hypothesis is that FLT Responders would have prolonged OS compared with FLT Progressive Disease.||3.16|0.04|0.327
72549346|NCT04885296|144628710|NON_INFERIORITY|Non-inferiority was declared if the lower bound of the 2-sided 95% confidence interval of the mean difference (Test - Control) was greater than -5. A 5-point increase in an average CLUE score translates into 10% shift in the distribution of scores for population of soft disposable contact lens wearers.|LS Mean Difference|0.4|STANDARD_ERROR_OF_MEAN|1.32|||TWO_SIDED|95.0|-2.2|3.0|||Linear Mixed Model|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.|LS Mean difference was calculated as Test - Control|||3.0|-2.2|
72549347|NCT04885296|144628711|NON_INFERIORITY|Non-inferiority was declared if the lower bound of the 2-sided 95% confidence interval of the mean difference (Test - Control) was greater than -5. A 5-point increase in an average CLUE score translates into 10% shift in the distribution of scores for population of soft disposable contact lens wearers.|LS Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|1.62|||TWO_SIDED|95.0|-4.0|2.3|||Linear Mixed Model|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.|LS Mean difference was calculated as Test - Control|||2.3|-4.0|
72549348|NCT04885296|144628712|NON_INFERIORITY|Non-inferiority was declared if the lower bound of the 2-sided 95% confidence interval of the mean difference (Test - Control) was greater than -5. A 5-point increase in an average CLUE score translates into 10% shift in the distribution of scores for population of soft disposable contact lens wearers.|LS Mean Difference|-1.5|STANDARD_ERROR_OF_MEAN|1.61|||TWO_SIDED|95.0|-4.7|1.7|||Linear Mixed Model|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.|LS Mean difference was calculated as Test - Control|||1.7|-4.7|
72549349|NCT00862979|144628713|SUPERIORITY||Mean Difference (Net)|-11.3|||<|0.0001|TWO_SIDED|95.0|-16.5|-6.1|||ANCOVA|||||-6.1|-16.5|<.0001
72549350|NCT00862979|144628714|OTHER|difference||||||0.203|||||||Fisher Exact|||Month 6 to Month 9||||0.203
72549351|NCT00862979|144628714|OTHER|difference||||||0.002|||||||Fisher Exact|||Month 9 to Month 18||||0.002
72549352|NCT00862979|144628716|SUPERIORITY||Mean Difference (Final Values)|-14.0|||<|0.0001|TWO_SIDED|95.0|-19.6|-8.3|||ANCOVA|||Month 12||-8.3|-19.6|<.0001
72549353|NCT00862979|144628716|SUPERIORITY||Mean Difference (Final Values)|-11.3|||<|0.0001|TWO_SIDED|95.0|-16.5|-6.1|||ANCOVA|||Month 18||-6.1|-16.5|<.0001
72549354|NCT00862979|144628718|SUPERIORITY|||||||0.008|||||||Wilcoxon (Mann-Whitney)|||||||0.008
72549355|NCT01545076|144628741|SUPERIORITY||Difference in Percent|-24.6|||=|0.007|TWO_SIDED|95.0|-40.7|-6.21|||Fisher Exact|||||-6.21|-40.7|=0.007
72549356|NCT01545076|144628741|SUPERIORITY||Difference in Percent|-30.4|||<|0.001|TWO_SIDED|95.0|-46.0|-12.2|||Fisher Exact|||||-12.2|-46.0|<0.001
72549357|NCT01545076|144628742|OTHER||Median Difference (Net)|0.0|||=|0.005|TWO_SIDED|95.0|-1.0|0.0|||Wilcoxon rank sum|||||0|-1|=0.005
72549358|NCT01545076|144628742|OTHER||Median Difference (Net)|-1.0|||<|0.001|TWO_SIDED|95.0|-1.0|0.0|||Wilcoxon rank sum|||||0|-1|<0.001
72549359|NCT01545076|144628743|OTHER||Median Difference (Net)|7.6|||=|0.004|TWO_SIDED|95.0|2.0|14.0|||Wilcoxon rank sum|||||14|2|=0.004
72549360|NCT01545076|144628743|OTHER||Median Difference (Net)|5.7|||=|0.014|TWO_SIDED|95.0|0.7|11.7|||Wilcoxon rank sum|||||11.7|0.7|=0.014
72549361|NCT01545076|144628744|OTHER||Median Difference (Final Values)|2.0|||=|0.003|TWO_SIDED|95.0|1.0|4.0|||Wilcoxon rank sum|||||4|1|=0.003
72549362|NCT01545076|144628744|OTHER||Median Difference (Final Values)|2.0|||=|0.002|TWO_SIDED|95.0|1.0|4.0|||Wilcoxon rank sum|||||4|1|=0.002
72549363|NCT01545076|144628745|OTHER||Median Difference (Net)|3.0|||=|0.03|TWO_SIDED|95.0|0.0|9.0|||Wilcoxon rank sum|||||9|0|=0.03
72549364|NCT01545076|144628745|OTHER||Median Difference (Net)|5.0|||<|0.001|TWO_SIDED|95.0|2.0|9.0|||Wilcoxon rank sum|||||9|2|<0.001
72549365|NCT02252562|144628772|EQUIVALENCE|We hypothesized a potential 66% reduction from a baseline incidence of 0.16 on the basis of prior interventions, but we assumed for power considerations a more conservative reduction of 40% from a baseline incidence of 0.12 averaged across all patients in each arm. Assuming a 10% loss to follow-up, we required 1,600 patients per group for a power of 0.9 with a type 1 error of .05.|Odds Ratio (OR)|1.07|||||TWO_SIDED|95.0|0.82|1.4|||fixed effects univariable analysis|||||1.40|0.82|
72549366|NCT00860405|144628817|NON_INFERIORITY_OR_EQUIVALENCE|Assuming a coefficient of variation of 0.363 and a desired power of 90 % with a type I level of 2.5 %, N=11 patients per treatment group were needed. The power was calculated by means of the software SAS, version 9.1.3, PROC POWER. Nevertheless, more patients were required for the assessment of safety, therefore 2 × 30 patients were planned to be included in this study.|Ratio of LS-means|0.98|||||TWO_SIDED|95.0|0.84|1.16||Null hypothesis tested by calculating a 2-sided 95% CI for ratio of LS-means μVoluven/μHSA based on ANOVA incl.treatment+centre as effects. If 95% CI was within equivalence range(0.55, 1.82), significant equivalence was concluded (Type I error: 2.5%)|ANOVA|Primary endpoint specified + analysed for PP and ITT population. Confirmatory analysis based on PP population only, no adjustment for multiplicity.|Considered ratio: μVoluven/μHSA = LS-mean of Voluven®/LS-mean of HSA 5%|The aim of the study was to prove equivalence, i.e. H0: μVoluven/μHSA ≤ 0.55 or μVoluven/μHSA ≥ 1.82 H1: 0.55 \< μVoluven/μHSA \< 1.82 where μVoluven was the mean infused volume of Voluven® and μHSA was the mean infused volume of HSA 5%.||1.16|0.84|
72549367|NCT02465567|144628826|SUPERIORITY||Rate Ratio|0.76|||<|0.0001|TWO_SIDED|95.0|0.69|0.83|||Negative Binomial Regression|||||0.83|0.69|<0.0001
72549368|NCT02465567|144628826|SUPERIORITY||Rate Ratio|0.87||||0.0027|TWO_SIDED|95.0|0.79|0.95|||Negative Binomial Regression|||||0.95|0.79|0.0027
72582686|NCT01217112|144695766|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-9.9|STANDARD_ERROR_OF_MEAN|10.838||0.366|TWO_SIDED|90.0|-28.06|8.27|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||8.27|-28.06|0.366
72582687|NCT01217112|144695766|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.11|STANDARD_ERROR_OF_MEAN|10.692||0.844|TWO_SIDED|90.0|-15.81|20.03|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||20.03|-15.81|0.844
72582688|NCT01217112|144695766|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-15.96|STANDARD_ERROR_OF_MEAN|10.026||0.118|TWO_SIDED|90.0|-32.76|0.84|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.84|-32.76|0.118
72582689|NCT01217112|144695766|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.67|STANDARD_ERROR_OF_MEAN|10.256||0.518|TWO_SIDED|90.0|-23.86|10.51|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||10.51|-23.86|0.518
72582690|NCT01217112|144695767|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.17|STANDARD_ERROR_OF_MEAN|0.294||0.576|TWO_SIDED|90.0|-0.66|0.33|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.33|-0.66|0.576
72582691|NCT01217112|144695767|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.13|STANDARD_ERROR_OF_MEAN|0.283||0.648|TWO_SIDED|90.0|-0.6|0.34|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.34|-0.60|0.648
72582692|NCT01217112|144695767|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.21|STANDARD_ERROR_OF_MEAN|0.269||0.447|TWO_SIDED|90.0|-0.66|0.24|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.24|-0.66|0.447
72582693|NCT01217112|144695767|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.31|STANDARD_ERROR_OF_MEAN|0.283||0.273|TWO_SIDED|90.0|-0.79|0.16|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.16|-0.79|0.273
72549369|NCT02465567|144628826|SUPERIORITY||Rate Ratio|0.75|||<|0.0001|TWO_SIDED|95.0|0.69|0.83|||Negative Binomial Regression|||||0.83|0.69|<0.0001
72549370|NCT02465567|144628826|SUPERIORITY||Rate Ratio|0.86||||0.002|TWO_SIDED|95.0|0.79|0.95|||Negative Binomial Regression|||||0.95|0.79|0.0020
72549371|NCT02465567|144628827|SUPERIORITY||Hazard Ratio (HR)|0.88||||0.0035|TWO_SIDED|95.0|0.807|0.959|||Regression, Cox|||||0.959|0.807|0.0035
72549372|NCT02465567|144628827|SUPERIORITY||Hazard Ratio (HR)|0.887||||0.057|TWO_SIDED|95.0|0.814|0.966|||Regression, Cox|||||0.966|0.814|0.057
72549373|NCT02465567|144628827|SUPERIORITY||Hazard Ratio (HR)|0.866||||0.0011|TWO_SIDED|95.0|0.794|0.944|||Regression, Cox|||||0.944|0.794|0.0011
72582694|NCT01217112|144695768|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.56|STANDARD_ERROR_OF_MEAN|1.097||0.615|TWO_SIDED|90.0|-2.4|1.29|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||1.29|-2.40|0.615
72582695|NCT01217112|144695768|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.93|STANDARD_ERROR_OF_MEAN|0.973||0.342|TWO_SIDED|90.0|-0.7|2.57|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||2.57|-0.70|0.342
72582696|NCT01217112|144695768|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.95|STANDARD_ERROR_OF_MEAN|0.934||0.314|TWO_SIDED|90.0|-2.52|0.62|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.62|-2.52|0.314
72549374|NCT02465567|144628827|SUPERIORITY||Hazard Ratio (HR)|0.873||||0.0019|TWO_SIDED|95.0|0.801|0.951|||Regression, Cox|||||0.951|0.801|0.0019
72549375|NCT02465567|144628828|SUPERIORITY||Mean Difference (Final Values)|-0.51|||<|0.0001|TWO_SIDED|95.0|-0.68|-0.34|||Linear Repeated Measures|||||-0.34|-0.68|<0.0001
72549376|NCT02465567|144628828|SUPERIORITY||Mean Difference (Final Values)|-0.37|||<|0.0001|TWO_SIDED|95.0|-0.54|-0.2|||Linear Repeated Measures|||||-0.20|-0.54|<0.0001
72549377|NCT02465567|144628828|SUPERIORITY||Mean Difference (Final Values)|-0.35|||<|0.0001|TWO_SIDED|95.0|-0.53|-0.18|||Linear Repeated Measures|||||-0.18|-0.53|<0.0001
72549378|NCT02465567|144628828|SUPERIORITY||Mean Difference (Final Values)|-0.22||||0.0127|TWO_SIDED|95.0|-0.39|-0.05|||Linear Repeated Measures|||||-0.05|-0.39|0.0127
72549379|NCT02465567|144628829|SUPERIORITY||Odds Ratio (OR)|1.358|||<|0.0001|TWO_SIDED|95.0|1.199|1.539|||Regression, Logistic|||||1.539|1.199|<0.0001
72549380|NCT02465567|144628829|SUPERIORITY||Odds Ratio (OR)|1.246||||0.0005|TWO_SIDED|95.0|1.1|1.41|||Regression, Logistic|||||1.410|1.100|0.0005
72549381|NCT02465567|144628829|SUPERIORITY||Odds Ratio (OR)|1.283|||<|0.0004|TWO_SIDED|95.0|1.133|1.454|||Regression, Logistic|||||1.454|1.133|<0.0004
72549382|NCT02465567|144628829|SUPERIORITY||Odds Ratio (OR)|1.177||||0.0103|TWO_SIDED|95.0|1.039|1.333|||Regression, Logistic|||||1.333|1.039|0.0103
72549383|NCT02465567|144628830|SUPERIORITY||Hazard Ratio (HR)|0.544||||0.0111|TWO_SIDED|95.0|0.34|0.87|||Regression, Cox|||||0.870|0.340|0.0111
72549384|NCT02465567|144628830|SUPERIORITY||Hazard Ratio (HR)|0.782||||0.3401|TWO_SIDED|95.0|0.472|1.296|||Regression, Cox|||||1.296|0.472|0.3401
72549385|NCT02465567|144628830|SUPERIORITY||Hazard Ratio (HR)|0.789||||0.269|TWO_SIDED|95.0|0.518|1.201|||Regression, Cox|||||1.201|0.518|0.2690
72549386|NCT02465567|144628830|SUPERIORITY||Hazard Ratio (HR)|1.134||||0.5918|TWO_SIDED|95.0|0.716|1.796|||Regression, Cox|||||1.796|0.716|0.5918
72549387|NCT02465567|144628831|SUPERIORITY||Rate Ratio|0.84||||0.6552|TWO_SIDED|95.0|0.69|1.03|||Negative Binomial Regression|||||1.03|0.69|0.6552
72549388|NCT02465567|144628831|SUPERIORITY||Rate Ratio|0.8||||0.0221|TWO_SIDED|95.0|0.66|0.97|||Negative Binomial Regression|||||0.97|0.66|0.0221
72549389|NCT02465567|144628831|SUPERIORITY||Rate Ratio|0.88||||0.2157|TWO_SIDED|95.0|0.72|1.08|||Negative Binomial Regression|||||1.08|0.72|0.2157
72549390|NCT02465567|144628831|SUPERIORITY||Rate Ratio|0.83||||0.0647|TWO_SIDED|95.0|0.69|1.01|||Negative Binomial Regression|||||1.01|0.69|0.0647
72549391|NCT00497796|144628838|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Based on the ICH guidance, the hypothesis of non-inferiority can be tested using a one-sided 97.5% confidence interval's (CI) upper bound comparing with the non-inferiority margin of 5% (0.05).|Rate difference|0.041|||||TWO_SIDED|95.0|-0.038|0.119|||||Rate difference is the rate of maribavir minus the rate of ganciclovir|||0.119|-0.038|
72549392|NCT00497796|144628838|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.586||||0.2754|TWO_SIDED|95.0|0.682|3.69||The p-value is from the Cochran-Mantel-Haenszel test, adjusting for receipt of induction ALA and geographic region (US or Europe).|Cochran-Mantel-Haenszel|||||3.690|0.682|0.2754
72549393|NCT00497796|144628839|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.793||||0.0283|TWO_SIDED|95.0|1.065|3.02||The p-value is from the Cochran-Mantel-Haenszel test, adjusting for receipt of induction ALA and geographic region (US or Europe).|Cochran-Mantel-Haenszel||Mantel-Haenszel odds ratio for maribavir versus ganciclovir|Analysis of the pp65 antigenemia assay||3.020|1.065|0.0283
72549394|NCT00497796|144628839|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.284||||0.0024|TWO_SIDED|95.0|1.338|3.9|||Cochran-Mantel-Haenszel|The p-value is from the Cochran-Mantel-Haenszel test, adjusting for receipt of induction ALA and geographic region (US or Europe).|Mantel-Haenszel odds ratio for maribavir versus ganciclovir|Analysis of CMV DNA PCR assay||3.900|1.338|0.0024
72549395|NCT00497796|144628839|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.177||||0.0053|TWO_SIDED|95.0|1.259|3.767||The p-value is from the Cochran-Mantel-Haenszel test, adjusting for receipt of induction ALA and geographic region (US or Europe).|Cochran-Mantel-Haenszel||Mantel-Haenszel odds ratio for maribavir versus ganciclovir|Analysis of pp65 antigenemia or CMV DNA PCR assay||3.767|1.259|0.0053
72549396|NCT00497796|144628839|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.388||||0.2339|TWO_SIDED|95.0|0.811|2.377||The p-value is from the Cochran-Mantel-Haenszel test, adjusting for receipt of induction ALA and geographic region (US or Europe).|Cochran-Mantel-Haenszel||Mantel-Haenszel odds ratio for maribavir versus ganciclovir|Analysis of initiation of anti-CMV therapy||2.377|0.811|0.2339
72549397|NCT00497796|144628840|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Hazard Ratio|2.25|||<|0.0001|TWO_SIDED|95.0|1.62|3.14|||Log Rank||Maribavir versus ganciclovir; Cox's proportional hazards regression model: time = receipt of induction ALA and geographic region (US or Europe) + treatment.|Analysis of time to onset||3.14|1.62|<0.0001
72549398|NCT00497796|144628841|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0008|TWO_SIDED|||||The p-value is from the Cochran-Mantel-Haenszel test, adjusting for receipt of induction ALA and geographic region (US or Europe).|Cochran-Mantel-Haenszel|||Analysis of 100 days post-transplant||||0.0008
72549399|NCT00497796|144628841|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3742|TWO_SIDED|||||The p-value is from the Cochran-Mantel-Haenszel test, adjusting for receipt of induction ALA and geographic region (US or Europe).|Cochran-Mantel-Haenszel|||Analysis of 6 months post-transplant||||0.3742
72549400|NCT00497796|144628842|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0007|TWO_SIDED|||||The p-value is from the Cochran-Mantel-Haenszel test, adjusting for receipt of induction ALA and geographic region (US or Europe).|Cochran-Mantel-Haenszel|||||||0.0007
72549401|NCT00497796|144628843|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|4.041|||<|0.0001|TWO_SIDED|95.0|2.179|7.494||The p-value is from the Cochran-Mantel-Haenszel test, adjusting for receipt of induction ALA and geographic region (US or Europe).|Cochran-Mantel-Haenszel||Mantel-Haenszel odds ratio for maribavir versus ganciclovir|Analysis of pp65 antigenemia assay||7.494|2.179|<0.0001
72582697|NCT01217112|144695768|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.14|STANDARD_ERROR_OF_MEAN|0.964||0.889|TWO_SIDED|90.0|-1.48|1.75|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||1.75|-1.48|0.889
72582698|NCT01217112|144695769|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|50.89|STANDARD_ERROR_OF_MEAN|168.459||0.764|TWO_SIDED|90.0|-232.02|333.8|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||333.80|-232.02|0.764
72582699|NCT01217112|144695769|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-70.76|STANDARD_ERROR_OF_MEAN|156.72||0.654|TWO_SIDED|90.0|-333.96|192.44|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||192.44|-333.96|0.654
72582700|NCT01217112|144695769|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-111.5|STANDARD_ERROR_OF_MEAN|146.276||0.45|TWO_SIDED|90.0|-357.17|134.16|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||134.16|-357.17|0.450
72582701|NCT01217112|144695769|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|97.42|STANDARD_ERROR_OF_MEAN|149.124||0.517|TWO_SIDED|90.0|-153.02|347.86|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||347.86|-153.02|0.517
72582702|NCT01217112|144695770|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|8.33|STANDARD_ERROR_OF_MEAN|40.94||0.84|TWO_SIDED|90.0|-60.28|76.94|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||76.94|-60.28|0.840
72549402|NCT00497796|144628843|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|6.448|||<|0.0001|TWO_SIDED|95.0|3.404|12.213||The p-value is from the Cochran-Mantel-Haenszel test, adjusting for receipt of induction ALA and geographic region (US or Europe).|Cochran-Mantel-Haenszel||Mantel-Haenszel odds ratio for maribavir versus ganciclovir|Analysis of CMV DNA PCR assay||12.213|3.404|<0.0001
72549403|NCT00497796|144628843|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|6.02|||<|0.0001|TWO_SIDED|95.0|3.342|10.843||The p-value is from the Cochran-Mantel-Haenszel test, adjusting for receipt of induction ALA and geographic region (US or Europe).|Cochran-Mantel-Haenszel||Mantel-Haenszel odds ratio for maribavir versus ganciclovir|Analysis of pp65 antigenemia or CMV DNA PCR assay||10.843|3.342|<0.0001
72549404|NCT00497796|144628843|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|11.165|||<|0.0001|TWO_SIDED|95.0|4.146|30.069||The p-value is from the Cochran-Mantel-Haenszel test, adjusting for receipt of induction ALA and geographic region (US or Europe).|Cochran-Mantel-Haenszel||Mantel-Haenszel odds ratio for maribavir versus ganciclovir|Analysis of initiation of anti-CMV therapy||30.069|4.146|<0.0001
72549405|NCT01807637|144628851|SUPERIORITY||Mean Difference (Final Values)|9.1|STANDARD_ERROR_OF_MEAN|5.37||0.05|TWO_SIDED||||||Mixed Models Analysis|||||||.05
72582703|NCT01217112|144695770|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|8.31|STANDARD_ERROR_OF_MEAN|39.521||0.834|TWO_SIDED|90.0|-57.92|74.55|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||74.55|-57.92|0.834
72582704|NCT01217112|144695770|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-11.62|STANDARD_ERROR_OF_MEAN|39.044||0.767|TWO_SIDED|90.0|-77.06|53.81|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||53.81|-77.06|0.767
72582705|NCT01217112|144695770|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|42.51|STANDARD_ERROR_OF_MEAN|39.68||0.289|TWO_SIDED|90.0|-23.99|109.01|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||109.01|-23.99|0.289
72582706|NCT01217112|144695771|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.06|STANDARD_ERROR_OF_MEAN|0.106||0.569|TWO_SIDED|90.0|-0.24|0.12|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.12|-0.24|0.569
72582707|NCT01217112|144695771|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.101||0.984|TWO_SIDED|90.0|-0.17|0.17|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.17|-0.17|0.984
72549406|NCT01807637|144628852|SUPERIORITY||Mean Difference (Final Values)|-2.05|STANDARD_DEVIATION|1.12||0.05|TWO_SIDED||||||ANOVA|||||||.05
72549407|NCT01807637|144628853|SUPERIORITY||Mean Difference (Final Values)|15.67|STANDARD_DEVIATION|3.41||0.05|TWO_SIDED||||||ANOVA|||||||.05
72549408|NCT00320112|144628861|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.58||||0.004|TWO_SIDED|||||no differences between arms in baseline characteristics at \<0.1 level, further analyses adjusted for variables that could influence the outcome like insulin use, age, commodities. because no differences in results, unadjusted analyses are reported.|Regression, Linear|we used STATA 11's xtmixed command, which fits multi-level mixed-effects linear regression models, with clustering by assigned pairs.||||||0.004
72549409|NCT00320112|144628862|SUPERIORITY_OR_OTHER|||||||0.91|TWO_SIDED|||||this is a priori design|Regression, Linear|||||||.91
72549410|NCT00320112|144628863|SUPERIORITY_OR_OTHER|||||||0.1|TWO_SIDED||||||Regression, Linear|||||||0.10
72549411|NCT00320112|144628864|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED||||||Regression, Linear|||||||0.02
72549412|NCT02899338|144628865|EQUIVALENCE|The relative bioavailability of BI 695501 using AI (A) compared with BI 695501 using PFS (B) was estimated, in an exploratory manner, by the ratios of the geometric means (A/B) using the analysis of variance (ANOVA)|Adjusted geometric mean ratio|101.71|STANDARD_ERROR_OF_MEAN|42.28|||TWO_SIDED|90.0|91.31|113.29|||ANOVA|The results are based on ANOVA model on the logarithmic scale with fixed effects for treatment and baseline body weight.|Standard error of the mean is actually the Inter-individual geometric coefficient of variation (gCV)|Comparison AI versus PFS||113.29|91.31|
72549413|NCT02899338|144628866|EQUIVALENCE|The relative bioavailability of BI 695501 using AI (A) compared with BI 695501 using PFS (B) was estimated, in an exploratory manner, by the ratios of the geometric means (A/B) using ANOVA|Adjusted geometric mean ratio|100.11|STANDARD_ERROR_OF_MEAN|23.72|||TWO_SIDED|90.0|94.17|106.43|||ANOVA|The results are based on ANOVA model on the logarithmic scale with fixed effects for treatment and baseline body weight.|Standard error of the mean is actually the Inter-individual gCV|Comparison AI versus PFS||106.43|94.17|
72549414|NCT02899338|144628867|EQUIVALENCE|The relative bioavailability of BI 695501 using AI (A) compared with BI 695501 using PFS (B) was estimated, in an exploratory manner, by the ratios of the geometric means (A/B) using ANOVA|Adjusted geometric mean ratio|103.19|STANDARD_ERROR_OF_MEAN|48.21|||TWO_SIDED|90.0|91.38|116.53|||ANOVA|The results are based on ANOVA model on the logarithmic scale with fixed effects for treatment and baseline body weight.|Standard error of the mean is actually the Inter-individual gCV|Comparison AI versus PFS||116.53|91.38|
72582708|NCT01217112|144695771|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.13|STANDARD_ERROR_OF_MEAN|0.098||0.176|TWO_SIDED|90.0|-0.3|0.03|||ANCOVA|||v Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.03|-0.30|0.176
72582709|NCT01217112|144695771|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.099||0.895|TWO_SIDED|90.0|-0.15|0.18|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.18|-0.15|0.895
72582710|NCT01217112|144695772|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.12|STANDARD_ERROR_OF_MEAN|0.745||0.871|TWO_SIDED|90.0|-1.13|1.37|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||1.37|-1.13|0.871
72582711|NCT01217112|144695772|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.16|STANDARD_ERROR_OF_MEAN|0.721||0.826|TWO_SIDED|90.0|-1.05|1.37|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||1.37|-1.05|0.826
72582712|NCT01217112|144695772|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.28|STANDARD_ERROR_OF_MEAN|0.703||0.693|TWO_SIDED|90.0|-1.46|0.9|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.90|-1.46|0.693
72582713|NCT01217112|144695772|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.45|STANDARD_ERROR_OF_MEAN|0.722||0.536|TWO_SIDED|90.0|-0.76|1.66|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||1.66|-0.76|0.536
72582714|NCT01217112|144695773|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.33|STANDARD_ERROR_OF_MEAN|8.633||0.878|TWO_SIDED|90.0|-15.8|13.13|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||13.13|-15.80|0.878
72582715|NCT01217112|144695773|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.85|STANDARD_ERROR_OF_MEAN|8.377||0.919|TWO_SIDED|90.0|-13.18|14.89|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||14.89|-13.18|0.919
72582716|NCT01217112|144695773|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.72|STANDARD_ERROR_OF_MEAN|7.989||0.557|TWO_SIDED|90.0|-8.67|18.11|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||18.11|-8.67|0.557
72582717|NCT01217112|144695773|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|9.2|STANDARD_ERROR_OF_MEAN|8.328||0.275|TWO_SIDED|90.0|-4.76|23.16|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||23.16|-4.76|0.275
72549415|NCT00796822|144628878|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.87|STANDARD_DEVIATION|1.09||0.44|TWO_SIDED|95.0|-1.53|3.28|||t-test, 2 sided|||The sample size was determined based on a two-sample, independent, two-tailed t-test with 5% type I error. Using the results from our pilot trial, we conservatively estimated a predicted absolute change in FMD of 3.5% with PTX (assuming no change with placebo) and we assumed a common standard deviation of 2.6%. A sample size of 10 per group was estimated to provide at least 80% power to detect this effect size. Allowing for a 20% dropout rate, we planned to recruit 13 subjects per group.||3.28|-1.53|0.44
72582718|NCT01217112|144695774|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|10.45|STANDARD_ERROR_OF_MEAN|16.445||0.528|TWO_SIDED|90.0|-17.12|38.01|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||38.01|-17.12|0.528
72549416|NCT00796822|144628879|SUPERIORITY|There was no formal power calculation for this outcome measure as the study was powered on the primary outcome measure.|Median Difference (Net)|149.1|STANDARD_DEVIATION|151.8||0.03|TWO_SIDED|95.0|16.4|281.9|||t-test, 2 sided|||||281.9|16.4|0.03
72549417|NCT00117949|144628882|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Log Rank|||||||<0.001
72549418|NCT00117949|144628882|SUPERIORITY_OR_OTHER||Median days to insufficient T response|84.0||||||95.0|35.0|112.0||||||Kaplan-Meier estimates of the time to meet insufficient testosterone (T) response.||112|35|
72549419|NCT00117949|144628882|SUPERIORITY_OR_OTHER||Median days to insufficient T response|98.0||||||95.0|70.0|126.0||||||Kaplan-Meier estimates of the time to meet insufficient testosterone (T) response||126|70|
72549420|NCT00117949|144628882|SUPERIORITY_OR_OTHER||Median days to insufficient T response|35.0||||||95.0|14.0|98.0||||||Kaplan-Meier estimates of the time to meet insufficient testosterone (T) response||98|14|
72549421|NCT00117949|144628883|SUPERIORITY_OR_OTHER|||||||0.003||95.0|||||Log Rank|Participants not castrated were censored as of the days from dosing for the last available observation.||||||0.003
72549422|NCT00117949|144628883|SUPERIORITY_OR_OTHER||Median time to castration (days)|3.0||||||95.0|3.0|7.0||||||Kaplan-Meier estimates of the median time to testosterone castration.||7|3|
72549423|NCT00117949|144628883|SUPERIORITY_OR_OTHER||Median time to castration (days)|3.0||||||95.0|1.0|3.0||||||Kaplan-Meier estimates of the time to testosterone castration.||3|1|
72582719|NCT01217112|144695774|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|15.825||0.99|TWO_SIDED|90.0|-26.32|26.72|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||26.72|-26.32|0.990
72582720|NCT01217112|144695774|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.39|STANDARD_ERROR_OF_MEAN|15.369||0.776|TWO_SIDED|90.0|-21.37|30.15|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||30.15|-21.37|0.776
72549424|NCT00117949|144628884|SUPERIORITY_OR_OTHER||Percentage of participants|0.0||||||95.0|0.0|0.0||||||Kaplan-Meier estimates of the percentage of participants with sufficient testosterone suppression.||0|0|
72549425|NCT00117949|144628884|SUPERIORITY_OR_OTHER||Percentage of participants|42.7||||||95.0|22.0|63.4||||||Kaplan-Meier estimates of the percentage of participants with sufficient testosterone suppression.||63.4|22|
72549426|NCT00117949|144628884|SUPERIORITY_OR_OTHER||Percentage of participants|61.6||||||95.0|41.8|81.3||||||Kaplan-Meier estimates of the percentage of participants with sufficient testosterone suppression.||81.3|41.8|
72549427|NCT00117949|144628884|SUPERIORITY_OR_OTHER||Percentage of participants|35.6||||||95.0|15.8|55.5||||||Kaplan-Meier estimates of the percentage of participants with sufficient testosterone suppression.||55.5|15.8|
72549428|NCT00117949|144628885|SUPERIORITY_OR_OTHER|||||||0.181||95.0|||||Cochran-Armitage Trend Test.|||||||0.181
72549429|NCT00117949|144628885|SUPERIORITY_OR_OTHER||Percentage of participants|10.0||||||95.0|0.3|44.5||||||Kaplan Meier-estimates of the percentage of participants with testostestone serum levels below 0.5 ng/mL for at least 28 days.||44.5|0.3|
72549430|NCT00117949|144628885|SUPERIORITY_OR_OTHER||Percentage of participants|70.8||||||95.0|48.9|87.4||||||Kaplan Meier-estimates of the percentage of participants with testostestone serum levels below 0.5 ng/mL for at least 28 days.||87.4|48.9|
72549431|NCT00117949|144628885|SUPERIORITY_OR_OTHER||Percentage of participants|79.2||||||95.0|57.8|92.9||||||Kaplan Meier-estimates of the percentage of participants with testostestone serum levels below 0.5 ng/mL for at least 28 days.||92.9|57.8|
72549432|NCT00117949|144628885|SUPERIORITY_OR_OTHER||Percentage of participants|54.2||||||95.0|32.8|74.4||||||Kaplan Meier-estimates of the percentage of participants with testostestone serum levels below 0.5 ng/mL for at least 28 days.||74.4|32.8|
72549433|NCT00117949|144628886|SUPERIORITY_OR_OTHER|||||||0.046||95.0|||||Log Rank|||||||0.046
72549434|NCT00117949|144628886|SUPERIORITY_OR_OTHER||days|14.0||||||95.0|14.0|28.0||||||Kaplan-Meier estimates of the time (days) to 50% reduction in PSA||28|14|
72549435|NCT00117949|144628886|SUPERIORITY_OR_OTHER||days|14.0||||||95.0|14.0|28.0||||||Kaplan-Meier estimates of the time (days) to 50% reduction in PSA||28|14|
72549436|NCT00117949|144628886|SUPERIORITY_OR_OTHER||days|28.0||||||95.0|14.0|41.0||||||Kaplan-Meier estimates of the time (days) to 50% reduction in PSA||41|14|
72549437|NCT00117949|144628887|SUPERIORITY_OR_OTHER|||||||0.926||95.0|||||Log Rank|||||||0.926
72549438|NCT00117949|144628887|SUPERIORITY_OR_OTHER||days|56.0||||||95.0|35.0|56.0||||||Kaplan-Meier estimates of the time (days) to 90% reduction in PSA.||56|35|
72549439|NCT00117949|144628887|SUPERIORITY_OR_OTHER||days|56.0||||||95.0|35.0|84.0||||||Kaplan-Meier estimates of the time (days) to 90% reduction in PSA.||84|35|
72582721|NCT01217112|144695774|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|44.51|STANDARD_ERROR_OF_MEAN|15.834||0.007|TWO_SIDED|90.0|17.98|71.05|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||71.05|17.98|0.007
72582722|NCT01217112|144695775|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|0.536||0.717|TWO_SIDED|90.0|-0.7|1.09|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||1.09|-0.70|0.717
72549440|NCT00117949|144628887|SUPERIORITY_OR_OTHER||days|56.0||||||95.0|35.0|100.0|||||The upper confidence interval limit could not be calculated. For technical reasons it has been entered as 100.|Kaplan-Meier estimates of the time (days) to 90% reduction in PSA.||100|35|
72549441|NCT04591626|144628889|SUPERIORITY||LS Mean Difference|-0.95|||<|0.001|TWO_SIDED|95.0|-1.14|-0.77|||Mixed Models Analysis|||||-0.77|-1.14|<0.001
72549442|NCT04591626|144628890|SUPERIORITY||Odds Ratio (OR)|10.91|||<|0.001|TWO_SIDED|95.0|5.35|22.28|||Regression, Logistic|||||22.28|5.35|<0.001
72549443|NCT04591626|144628891|SUPERIORITY||LS Mean Difference|-1.18|||<|0.001|TWO_SIDED|95.0|-1.77|-0.6|||Mixed Models Analysis|||||-0.60|-1.77|<0.001
72549444|NCT04591626|144628892|SUPERIORITY||LS Mean Difference|-14.82|||<|0.001|TWO_SIDED|95.0|-20.57|-9.08|||Mixed Models Analysis|||||-9.08|-20.57|<0.001
72549445|NCT04591626|144628893|SUPERIORITY||Odds Ratio (OR)|4.58|||<|0.001|TWO_SIDED|95.0|2.64|7.95|||Regression, Logistic||OR was determined using Logistic Regression model with Baseline HbA1c value + OAM use + Treatment as variables.|||7.95|2.64|<0.001
72549446|NCT04591626|144628894|SUPERIORITY||Odds Ratio (OR)|7.59|||<|0.001|TWO_SIDED|95.0|4.27|13.48|||Regression, Logistic||OR was determined using logistic regression model: Variable = Baseline HbA1c value + OAM use + Treatment as variables.|||13.48|4.27|<0.001
72549447|NCT04591626|144628895|SUPERIORITY||Odds Ratio (OR)|4.58|||<|0.001|TWO_SIDED|95.0|2.64|7.95|||Regression, Logistic||OR was determined using logistic regression model with Baseline HbA1c value + OAM use + Treatment as variables.|||7.95|2.64|<0.001
72549448|NCT04591626|144628896|SUPERIORITY||LS Mean Difference|-26.3|||<|0.001|TWO_SIDED|95.0|-33.0|-19.6|||Mixed Models Analysis|||||-19.6|-33.0|<0.001
72549449|NCT04591626|144628897|SUPERIORITY||LS Mean Difference|-4.0||||0.006|TWO_SIDED|95.0|-6.86|-1.14|||Mixed Models Analysis|||||-1.14|-6.86|0.006
72582723|NCT01217112|144695775|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.66|STANDARD_ERROR_OF_MEAN|0.531||0.218|TWO_SIDED|90.0|-0.23|1.55|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||1.55|-0.23|0.218
72549450|NCT02672553|144628898|SUPERIORITY||Median Difference (Final Values)|-12.5|||<|0.0001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
72549451|NCT02672553|144628899|SUPERIORITY||Median Difference (Final Values)|-10.5||||0.2077|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.2077
72549452|NCT03676803|144628926|OTHER||Mean Difference (Final Values)|10.6||||0.033|TWO_SIDED|||||p\<0.05 was defined as significant|ANOVA|||Comparison was made to 2 weeks minus baseline changes in phylum Firmicutes abundance between groups.||||0.033
72549453|NCT03676803|144628926|OTHER||Mean Difference (Final Values)|8.7||||0.097|TWO_SIDED|||||p\<0.05 was defined as significant.|ANOVA|||Comparison was made to 2 weeks minus baseline changes in phylum Bacteroidetes abundance between groups.||||0.097
72549454|NCT03676803|144628927|OTHER||Mean Difference (Final Values)|86.0||||0.49|TWO_SIDED||||||t-test, 2 sided|||Comparison was made to 2 weeks minus baseline in mixed spices intervention group||||0.49
72549455|NCT03676803|144628927|OTHER||Mean Difference (Final Values)|55.7||||0.53|TWO_SIDED||||||t-test, 2 sided|||Comparison was made to 2 weeks minus baseline in placebo group||||0.53
72549456|NCT01355081|144628929|SUPERIORITY_OR_OTHER||Least square means difference|-2.03|STANDARD_ERROR_OF_MEAN|1.241||0.1031|TWO_SIDED|95.0|-4.467|0.413|||ANCOVA|Change in MADRS total score as a dependent variable, treatment as a fixed effect and the baseline MADRS total score as a covariate.||||0.413|-4.467|0.1031
72549457|NCT01355081|144628929|SUPERIORITY_OR_OTHER||Least square mean difference|-1.04|STANDARD_ERROR_OF_MEAN|1.233||0.4008|TWO_SIDED|95.0|-3.461|1.387|||ANCOVA|Change in MADRS total score as a dependent variable, treatment as a fixed effect and the baseline MADRS total score as a covariate.||||1.387|-3.461|0.4008
72549458|NCT01475474|144628935|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon Signed-Rank Test|||Wilcoxon Signed-Rank Test used to evaluate median Percent Change-from-Baseline in ABL different from zero||||<0.001
72549459|NCT01475474|144628936|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon Signed-Rank Test|||Wilcoxon Signed-Rank Test used to evaluate median Percent Change-from-Baseline in Wexner score||||<0.001
72549460|NCT01868009|144628943|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The response was analyzed and adjusted for study inhaler use sequence and preference question version. The method accounted for participants who indicated no preference.|Cochran-Mantel-Haenszel|||||||<0.001
72549461|NCT01046253|144628983|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|105.0|||||TWO_SIDED|90.0|97.4|114.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||114|97.4|
72549462|NCT01046253|144628984|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|98.5|||||TWO_SIDED|90.0|93.3|104.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||104|93.3|
72582724|NCT01217112|144695775|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.46|STANDARD_ERROR_OF_MEAN|0.514||0.378|TWO_SIDED|90.0|-0.4|1.32|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||1.32|-0.40|0.378
72582725|NCT01217112|144695775|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.49|STANDARD_ERROR_OF_MEAN|0.532||0.361|TWO_SIDED|90.0|-0.4|1.38|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||1.38|-0.40|0.361
72549463|NCT01046253|144628985|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Slope|98.0|||||TWO_SIDED|90.0|92.8|104.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||104|92.8|
72549464|NCT00860028|144629011|SUPERIORITY_OR_OTHER_LEGACY|||||||0.36||95.0|||||Chi-squared|||||||0.36
72549465|NCT00860028|144629012|SUPERIORITY_OR_OTHER_LEGACY|||||||0.06||95.0|||||General Linear Model|||||||0.06
72549466|NCT00860028|144629013|SUPERIORITY_OR_OTHER_LEGACY|||||||0.03||95.0|||||Fisher Exact|||||||0.03
72549467|NCT01658943|144629017|SUPERIORITY_OR_OTHER|||||||0.15|TWO_SIDED||||||Log Rank|||||||0.15
72549468|NCT00890981|144629035|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.7||||0.0766||95.0|-0.4|7.8|||ANCOVA|||An analysis of covariance model was fit with main effects for randomized treatment in study 20050179, baseline value, time since last subcutaneous dose of denosumab or placebo in study 20050179 as a continuous variable, and the age stratification from 20050179. Model included linear, quadratic and cubic time terms with treatment-by-time interaction||7.8|-0.4|0.0766
72549469|NCT00890981|144629036|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.5||||0.1648||95.0|-0.6|3.5|||ANCOVA|||An analysis of covariance model was fit with main effects for randomized treatment in study 20050179, baseline value, time since last subcutaneous dose of denosumab or placebo in study 20050179 as a continuous variable, and the age stratification from 20050179. Model included linear time term but without treatment-by-time interaction.||3.5|-0.6|0.1648
72549470|NCT00890981|144629037|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.9||||0.0228||95.0|0.1|1.7|||ANCOVA|||An analysis of covariance model was fit with main effects for randomized treatment in study 20050179, baseline value, time since last subcutaneous dose of denosumab or placebo in study 20050179 as a continuous variable, and the age stratification from 20050179. Model included linear, quadratic and cubic time terms but without treatment-by-time interaction.||1.7|0.1|0.0228
72549471|NCT00890981|144629038|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.7||||0.656||95.0|-2.5|4.0|||ANCOVA|||An analysis of covariance model was fit with main effects for randomized treatment in study 20050179, baseline value, time since last subcutaneous dose of denosumab or placebo in study 20050179 as a continuous variable, and the age stratification from 20050179. Model includes linear, quadratic and cubic time terms but without treatment-by-time interaction.||4.0|-2.5|0.6560
72549472|NCT00890981|144629039|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.8||||0.0594||95.0|-0.1|3.7|||ANCOVA|||An analysis of covariance model was fit with main effects for randomized treatment in study 20050179, baseline value, time since last subcutaneous dose of denosumab or placebo in study 20050179 as a continuous variable, and the age stratification from 20050179. Model included linear time term but without treatment-by-time interaction.||3.7|-0.1|0.0594
72549473|NCT00890981|144629040|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.6||||0.0032||95.0|0.9|4.3|||ANCOVA|||An analysis of covariance model was fit with main effects for randomized treatment in study 20050179, baseline value, time since last subcutaneous dose of denosumab or placebo in study 20050179 as a continuous variable, and the age stratification from 20050179. Model included linear time term but without treatment-by-time interaction.||4.3|0.9|0.0032
72549474|NCT00890981|144629041|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.4||||0.2897||95.0|-0.4|1.2|||ANCOVA|||An analysis of covariance model was fit with main effects for randomized treatment in study 20050179, baseline value, time since last subcutaneous dose of denosumab or placebo in study 20050179 as a continuous variable, and the age stratification from 20050179. Model included linear, quadratic and cubic time terms but without treatment-by-time interaction.||1.2|-0.4|0.2897
72549475|NCT00890981|144629042|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.9||||0.0067||95.0|1.1|6.7|||ANCOVA|||An analysis of covariance model was fit with main effects for randomized treatment in study 20050179, baseline value, time since last subcutaneous dose of denosumab or placebo in study 20050179 as a continuous variable, and the age stratification from 20050179. Model included linear time term but without treatment-by-time interaction.||6.7|1.1|0.0067
72549476|NCT00890981|144629043|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.1||||0.0184||95.0|0.4|3.8|||ANCOVA|||An analysis of covariance model was fit with main effects for randomized treatment in study 20050179, baseline value, time since last subcutaneous dose of denosumab or placebo in study 20050179 as a continuous variable, and the age stratification from 20050179. Model included linear time term but without treatment-by-time interaction.||3.8|0.4|0.0184
72549477|NCT00890981|144629044|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.6||||0.0911||95.0|-0.3|3.5|||ANCOVA|||An analysis of covariance model was fit with main effects for randomized treatment in study 20050179, baseline value, time since last subcutaneous dose of denosumab or placebo in study 20050179 as a continuous variable, and the age stratification from 20050179. Model included linear time term but without treatment-by-time interaction.||3.5|-0.3|0.0911
72582726|NCT01217112|144695776|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.013||0.417|TWO_SIDED|90.0|-0.01|0.03|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.03|-0.01|0.417
72582727|NCT01217112|144695776|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.013||0.34|TWO_SIDED|90.0|-0.01|0.04|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.04|-0.01|0.340
72412703|NCT00489970|144333468|NON_INFERIORITY|One month after vaccination, the lower limit of the 97.5% CI for the difference between groups in the booster response rate \[a second dose of Boostrix (Adacel group) minus the first dose of Boostrix (Control group)\] against tetanus antigen was greater than or equal to -10% (clinical limit for non-inferiority).|Difference in booster response rate|-11.79|||||TWO_SIDED|97.5|-22.98|0.15|||||Standardized asymptotic 97.5% CI for the group difference in the Booster response was calculated.|To demonstrate that the immune response elicited by a second dose of Boostrix vaccine (Adacel group) was non-inferior to the immune response elicited by a first dose of Boostrix vaccine (Control group), with respect to booster response against tetanus antigen, one month following vaccination.||0.15|-22.98|
72412704|NCT00489970|144333469|NON_INFERIORITY|One month after vaccination, the lower limit of the 97.5% CI for the difference between groups in the booster response rate \[a second dose of Boostrix (Boostrix group) minus the first dose of Boostrix (Control group)\] against PT antigen was greater than or equal to -10% (clinical limit for non-inferiority).|Difference in booster response rate|-2.85|||||TWO_SIDED|97.5|-9.09|3.08|||||Standardized asymptotic 97.5% CI for the group difference in the Booster response was calculated.|To demonstrate that the immune response elicited by a second dose of Boostrix vaccine (Boostrix group) was non-inferior to the immune response elicited by a first dose of Boostrix vaccine (Control group), with respect to booster response against PT antigen, one month following vaccination.||3.08|-9.09|
72412705|NCT00489970|144333469|NON_INFERIORITY|One month after vaccination, the lower limit of the 97.5% CI for the difference between groups in the booster response rate \[a second dose of Boostrix (Boostrix group) minus the first dose of Boostrix (Control group)\] against FHA antigen was greater than or equal to -10% (clinical limit for non-inferiority).|Difference in booster response rate|-7.05|||||TWO_SIDED|97.5|-13.16|-1.4|||||Standardized asymptotic 97.5% CI for the group difference in the Booster response was calculated.|To demonstrate that the immune response elicited by a second dose of Boostrix vaccine (Boostrix group) was non-inferior to the immune response elicited by a first dose of Boostrix vaccine (Control group), with respect to booster response against FHA antigen, one month following vaccination.||-1.40|-13.16|
72412706|NCT00489970|144333469|NON_INFERIORITY|One month after vaccination, the lower limit of the 97.5% CI for the difference between groups in the booster response rate \[a second dose of Boostrix (Boostrix group) minus the first dose of Boostrix (Control group)\] against PRN antigen was greater than or equal to -10% (clinical limit for non-inferiority).|Difference in booster response rate|-10.32|||||TWO_SIDED|97.5|-17.5|-3.38|||||Standardized asymptotic 97.5% CI for the group difference in the Booster response was calculated.|To demonstrate that the immune response elicited by a second dose of Boostrix vaccine (Boostrix group) was non-inferior to the immune response elicited by a first dose of Boostrix vaccine (Control group), with respect to booster response against PRN antigen, one month following vaccination.||-3.38|-17.50|
72412707|NCT00489970|144333469|NON_INFERIORITY|One month after vaccination, the lower limit of the 97.5% CI for the difference between groups in the booster response rate \[a second dose of Boostrix (Adacel group) minus the first dose of Boostrix (Control group)\] against PT antigen was greater than or equal to -10% (clinical limit for non-inferiority).|Difference in booster response rate|-1.24|||||TWO_SIDED|97.5|-10.03|5.57|||||Standardized asymptotic 97.5% CI for the group difference in the Booster response was calculated.|To demonstrate that the immune response elicited by a second dose of Boostrix vaccine (Adacel group) was non-inferior to the immune response elicited by a first dose of Boostrix vaccine (Control group), with respect to booster response against PT antigen, one month following vaccination.||5.57|-10.03|
72412708|NCT00489970|144333469|NON_INFERIORITY|One month after vaccination, the lower limit of the 97.5% CI for the difference between groups in the booster response rate \[a second dose of Boostrix (Adacel group) minus the first dose of Boostrix (Control group)\] against FHA antigen was greater than or equal to -10% (clinical limit for non-inferiority).|Difference in booster response rate|4.01|||||TWO_SIDED|97.5|-2.38|8.66|||||Standardized asymptotic 97.5% CI for the group difference in the Booster response was calculated.|To demonstrate that the immune response elicited by a second dose of Boostrix vaccine (Adacel group) was non-inferior to the immune response elicited by a first dose of Boostrix vaccine (Control group), with respect to booster response against FHA antigen, one month following vaccination.||8.66|-2.38|
72412709|NCT00489970|144333469|NON_INFERIORITY|One month after vaccination, the lower limit of the 97.5% CI for the difference between groups in the booster response rate \[a second dose of Boostrix (Adacel group) minus the first dose of Boostrix (Control group)\] against PRN antigen was greater than or equal to -10% (clinical limit for non-inferiority).|Difference in booster response|-4.76|||||TWO_SIDED|97.5|-14.53|3.18|||||Standardized asymptotic 97.5% CI for the group difference in the Booster response was calculated.|To demonstrate that the immune response elicited by a second dose of Boostrix vaccine (Adacel group) was non-inferior to the immune response elicited by a first dose of Boostrix vaccine (Control group), with respect to booster response against PRN antigen, one month following vaccination.||3.18|-14.53|
72412710|NCT01159938|144333508|SUPERIORITY_OR_OTHER||LS mean difference|0.26||||0.617|TWO_SIDED|95.0|-0.78|1.3||P-value is for LS mean difference (high minus low postprandial glucose) in PWV at 30-min pre-breakfast in aortic arteries. Significance was assessed at the 2-sided 5% level.|ANCOVA|||||1.30|-0.78|0.617
72412711|NCT01159938|144333508|SUPERIORITY_OR_OTHER||LS Mean Difference|0.25||||0.732|TWO_SIDED|95.0|-1.23|1.73||P-value is for LS mean difference (high minus low postprandial glucose) in PWV at 30-min pre-breakfast in aortic arteries. Significance was assessed at the 2-sided 5% level.|ANCOVA|||||1.73|-1.23|0.732
72412712|NCT01159938|144333508|SUPERIORITY_OR_OTHER||LS Mean Difference|0.27||||0.715|TWO_SIDED|95.0|-1.2|1.73||P-value is for LS mean difference (high minus low postprandial glucose) in PWV at 30-min pre-breakfast in aortic arteries. Significance was assessed at the 2-sided 5% level.|ANCOVA|||||1.73|-1.20|0.715
72412713|NCT01159938|144333508|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.35||||0.177|TWO_SIDED|95.0|-0.85|0.16||P-value is for LS mean difference (high minus low postprandial glucose) in PWV at 30-min pre-breakfast in brachial arteries. Significance was assessed at 2-sided 5% level.|ANCOVA|||||0.16|-0.85|0.177
72412714|NCT01159938|144333508|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2||||0.579|TWO_SIDED|95.0|-0.94|0.53||P-value is for LS mean difference (high minus low postprandial glucose) in PWV at 30-min pre-breakfast in brachial arteries. Significance was assessed at the 2-sided 5% level.|ANCOVA|||||0.53|-0.94|0.579
72549478|NCT00890981|144629045|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.1||||0.0035||95.0|0.7|3.5|||ANCOVA|||An analysis of covariance model was fit with main effects for randomized treatment in study 20050179, baseline value, time since last subcutaneous dose of denosumab or placebo in study 20050179 as a continuous variable, and the age stratification from 20050179. Model included linear time term but without treatment-by-time interaction.||3.5|0.7|0.0035
72549479|NCT00890981|144629046|SUPERIORITY_OR_OTHER||Ratio of Denosumab to Placebo|1.1||||0.0591||95.0|1.0|1.3|||ANCOVA|||ANCOVA based on the log transformed actual values with main effects for randomized treatment in study 20050179, baseline value, time since last subcutaneous dose of denosumab or placebo in study 20050179 as a continuous variable, and the age stratification from 20050179. Model included linear time term but without treatment-by-time interaction.||1.3|1.0|0.0591
72549480|NCT00890981|144629047|SUPERIORITY_OR_OTHER||Ratio of Denosumab to Placebo|1.2||||0.0079||95.0|1.0|1.3|||ANCOVA|||ANCOVA based on the log transformed actual values with main effects for randomized treatment in study 20050179, baseline value, time since last subcutaneous dose of denosumab or placebo in study 20050179 as a continuous variable, and the age stratification from 20050179. Model included linear time term but without treatment-by-time interaction.||1.3|1.0|0.0079
72549481|NCT01027143|144629048|SUPERIORITY|||||||0.05|||||||ANCOVA|||||||0.05
72582728|NCT01217112|144695776|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.013||0.915|TWO_SIDED|90.0|-0.02|0.02|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.02|-0.02|0.915
72582729|NCT01217112|144695776|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.013||0.465|TWO_SIDED|90.0|-0.01|0.03|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.03|-0.01|0.465
72582730|NCT01217112|144695777|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.75|STANDARD_ERROR_OF_MEAN|1.616||0.646|TWO_SIDED|90.0|-1.96|3.45|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||3.45|-1.96|0.646
72582731|NCT01217112|144695777|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.99|STANDARD_ERROR_OF_MEAN|1.598||0.219|TWO_SIDED|90.0|-0.69|4.66|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||4.66|-0.69|0.219
72582732|NCT01217112|144695777|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.61|STANDARD_ERROR_OF_MEAN|1.563||0.307|TWO_SIDED|90.0|-1.0|4.23|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||4.23|-1.00|0.307
72582733|NCT01217112|144695777|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.52|STANDARD_ERROR_OF_MEAN|1.612||0.348|TWO_SIDED|90.0|-1.17|4.22|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||4.22|-1.17|0.348
72582734|NCT01217112|144695778|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.74|STANDARD_ERROR_OF_MEAN|1.299||0.187|TWO_SIDED|90.0|-0.44|3.91|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||3.91|-0.44|0.187
72582735|NCT01217112|144695778|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.72|STANDARD_ERROR_OF_MEAN|1.28||0.578|TWO_SIDED|90.0|-1.43|2.86|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||2.86|-1.43|0.578
72582736|NCT01217112|144695778|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.13|STANDARD_ERROR_OF_MEAN|1.249||0.368|TWO_SIDED|90.0|-0.96|3.22|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||3.22|-0.96|0.368
72549482|NCT02564263|144629056|SUPERIORITY||Hazard Ratio (HR)|0.77||||0.00894|TWO_SIDED|95.0|0.63|0.96||One-sided p-value based on stratified log-rank test|Log Rank||Cox regression model with treatment as a covariate stratified by geographic region (Asia vs RoW)|||0.96|0.63|0.00894
72582737|NCT01217112|144695778|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.51|STANDARD_ERROR_OF_MEAN|1.304||0.696|TWO_SIDED|90.0|-1.67|2.69|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||2.69|-1.67|0.696
72582738|NCT01217112|144695779|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.3|STANDARD_ERROR_OF_MEAN|1.32||0.327|TWO_SIDED|90.0|-0.9|3.51|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||3.51|-0.90|0.327
72582739|NCT01217112|144695779|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.25|STANDARD_ERROR_OF_MEAN|1.303||0.851|TWO_SIDED|90.0|-1.93|2.43|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||2.43|-1.93|0.851
72412715|NCT01159938|144333508|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.49||||0.167|TWO_SIDED|95.0|-1.19|0.21||P-value is for LS mean difference (high minus low postprandial glucose) in PWV at 30-min pre-breakfast in brachial arteries. Significance was assessed at 2-sided 5% level.|ANCOVA|||||0.21|-1.19|0.167
72582740|NCT01217112|144695779|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.54|STANDARD_ERROR_OF_MEAN|1.281||0.672|TWO_SIDED|90.0|-1.6|2.69|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||2.69|-1.60|0.672
72582741|NCT01217112|144695779|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.04|STANDARD_ERROR_OF_MEAN|1.327||0.978|TWO_SIDED|90.0|-2.26|2.18|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||2.18|-2.26|0.978
72582742|NCT01217112|144695780|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.09|STANDARD_ERROR_OF_MEAN|0.512||0.857|TWO_SIDED|90.0|-0.95|0.76|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.76|-0.95|0.857
72549483|NCT02564263|144629057|SUPERIORITY||Hazard Ratio (HR)|0.7||||0.00855|TWO_SIDED|95.0|0.52|0.94||One-sided p-value based on stratified log-rank test|Log Rank||Cox regression model with treatment as a covariate stratified by geographic region (Asia vs RoW) \& tumor histology (SCC vs adenocarcinoma/Siewert type 1 adenocarcinoma of the esophagogastric junction \[EGJ\])|||0.94|0.52|0.00855
72549484|NCT02564263|144629058|SUPERIORITY||Hazard Ratio (HR)|0.89||||0.0531|TWO_SIDED|95.0|0.75|1.05||One-sided p-value based on stratified maximum weighted log rank test: the maximum of the log-rank test statistic \& a weighted log-rank Fleming-Harrington (0,1) test statistic|Log Rank||Cox regression model with treatment as a covariate stratified by geographic region (Asia vs RoW) \& tumor histology (SCC vs adenocarcinoma/Siewert type 1 adenocarcinoma of the esophagogastric junction \[EGJ\])|||1.05|0.75|0.0531
72549485|NCT02564263|144629059|SUPERIORITY||Hazard Ratio (HR)|1.11||||0.287|TWO_SIDED|95.0|0.94|1.31||One-sided p-value based on stratified maximum weighted log rank test: the maximum of the log-rank test statistic \& a weighted log-rank Fleming-Harrington (0,1) test statistic|Log Rank||Cox regression model with treatment as a covariate stratified by geographic region (Asia vs RoW) \& tumor histology (SCC vs adenocarcinoma/Siewert type 1 adenocarcinoma of the EGJ)|||1.31|0.94|0.287
72549486|NCT02564263|144629060|SUPERIORITY||Difference in Percentages|6.4||||0.0037|TWO_SIDED|95.0|1.7|11.2||One-sided p-value for testing. H0: difference in %=0 versus; H1: difference in %\>0.|Miettinen & Nurminen method||Miettinen \& Nurminen method stratified by geographic region (Asia vs RoW) \& tumor histology (SCC vs adenocarcinoma/Siewert type I adenocarcinoma of the EGJ)|||11.2|1.7|0.0037
72549487|NCT02564263|144629061|SUPERIORITY||Hazard Ratio (HR)|0.92||||0.216|TWO_SIDED|95.0|0.75|1.13||One-sided p-value based on stratified log-rank test|Log Rank||Cox regression model with treatment as a covariate stratified by geographic region (Asia vs RoW)|||1.13|0.75|0.216
72549488|NCT02564263|144629062|SUPERIORITY||Hazard Ratio (HR)|0.73||||0.015|TWO_SIDED|95.0|0.54|0.97||One-sided p-value based on stratified log-rank test|Log Rank||Cox regression model with treatment as a covariate stratified by geographic region (Asia vs RoW) \& tumor histology (SCC vs adenocarcinoma/Siewert type 1 adenocarcinoma of the EGJ)|||0.97|0.54|0.015
72549489|NCT02564263|144629063|SUPERIORITY||Difference in Percentages|9.2||||0.0022|TWO_SIDED|95.0|3.0|15.8||One-sided p-value for testing. H0: difference in %=0; H1: difference in %\>0.|Miettinen & Nurminen method||Miettinen \& Nurminen method stratified by geographic region (Asia vs RoW)|||15.8|3.0|0.0022
72549490|NCT02564263|144629064|SUPERIORITY||Difference in Percentages|15.1||||0.0006|TWO_SIDED|95.0|6.2|24.7||One-sided p-value for testing. H0: difference in %=0; H1: difference in %\>0.|Miettinen & Nurminen method||Miettinen \& Nurminen method stratified by geographic region (Asia vs RoW) \& tumor histology (SCC vs adenocarcinoma/Siewert type I adenocarcinoma of the EGJ)|||24.7|6.2|0.0006
72549491|NCT02319148|144629067|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|105.28|||||TWO_SIDED|90.0|92.11|120.34|||Mixed Models Analysis|||||120.34|92.11|
72549492|NCT02319148|144629067|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|92.54|||||TWO_SIDED|90.0|80.96|105.77|||Mixed Models Analysis|||||105.77|80.96|
72549493|NCT02319148|144629067|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|116.36|||||TWO_SIDED|90.0|101.86|132.92|||Mixed Models Analysis|||||132.92|101.86|
72549494|NCT02319148|144629068|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|90.16|||||TWO_SIDED|90.0|78.57|103.46|||Mixed Models Analysis|||||103.46|78.57|
72549495|NCT02319148|144629068|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|106.38|||||TWO_SIDED|90.0|92.7|122.07|||Mixed Models Analysis|||||122.07|92.70|
72549496|NCT02319148|144629068|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|101.71|||||TWO_SIDED|90.0|88.68|116.66|||Mixed Models Analysis|||||116.66|88.68|
72549497|NCT02319148|144629069|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|91.33|||||TWO_SIDED|90.0|79.49|104.94|||Mixed Models Analysis|||||104.94|79.49|
72549498|NCT02319148|144629069|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|106.97|||||TWO_SIDED|90.0|93.1|122.91|||Mixed Models Analysis|||||122.91|93.10|
72549499|NCT02319148|144629069|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|102.69|||||TWO_SIDED|90.0|89.42|117.93|||Mixed Models Analysis|||||117.93|89.42|
72549500|NCT04276883|144629090|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||||||<0.0001
72549501|NCT04276883|144629090|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||||||<0.0001
72549502|NCT04276883|144629091|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||180 Micrograms versus placebo; 120 minutes post-dose||||<0.0001
72549503|NCT04276883|144629091|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||120 Micrograms versus placebo; 120 minutes post-dose||||<0.0001
72549504|NCT04276883|144629091|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||180 Micrograms versus placebo; 90 minutes post-dose||||<0.0001
72549505|NCT04276883|144629091|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||120 Micrograms versus placebo; 90 minutes post-dose||||<0.0001
72549506|NCT04276883|144629091|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||180 Micrograms versus placebo; 60 minutes post-dose||||<0.0001
72549507|NCT04276883|144629091|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||120 Micrograms versus placebo; 60 minutes post-dose||||<0.0001
72549508|NCT04276883|144629091|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||180 Micrograms versus placebo; 45 minutes post-dose||||<0.0001
72549509|NCT04276883|144629091|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||120 Micrograms versus placebo; 45 minutes post-dose||||<0.0001
72549510|NCT04276883|144629091|SUPERIORITY|||||||0.0006|||||||Mixed Models Analysis|||180 Micrograms versus placebo; 30 minutes post-dose||||0.0006
72549511|NCT04276883|144629091|SUPERIORITY|||||||0.0028|||||||Mixed Models Analysis|||120 Micrograms versus placebo; 30 minutes post-dose||||0.0028
72549512|NCT04276883|144629091|SUPERIORITY|||||||0.007|||||||Mixed Models Analysis|||180 Micrograms versus placebo; 20 minutes post-dose||||0.0070
72549513|NCT04276883|144629091|SUPERIORITY|||||||0.0092|||||||Mixed Models Analysis|||120 Micrograms versus placebo; 20 minutes post-dose||||0.0092
72549514|NCT00765648|144629114|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-9.3||||0.04|TWO_SIDED|95.0|-18.0|-0.6|||Chi-squared|||||-0.6|-18.0|0.04
72412716|NCT01159938|144333509|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.19||||0.676|TWO_SIDED|95.0|-1.1|0.72||P-value is for LS mean difference (high minus low postprandial glucose) in PWV at 60-min post-breakfast in aortic arteries. Significance was assessed at the 2-sided 5% level.|ANCOVA|||||0.72|-1.10|0.676
72549515|NCT00765648|144629115|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|95.0|||||t-test, 2 sided|||||||<0.001
72549516|NCT00765648|144629116|SUPERIORITY_OR_OTHER|||||||0.76|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||0.76
72549517|NCT00765648|144629117|SUPERIORITY_OR_OTHER|||||||0.38|TWO_SIDED|95.0|||||Chi-squared|||||||0.38
72582743|NCT01217112|144695780|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.34|STANDARD_ERROR_OF_MEAN|0.549||0.543|TWO_SIDED|90.0|-0.58|1.26|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||1.26|-0.58|0.543
72582744|NCT01217112|144695780|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.09|STANDARD_ERROR_OF_MEAN|0.495||0.859|TWO_SIDED|90.0|-0.74|0.92|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.92|-0.74|0.859
72582745|NCT01217112|144695780|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.39|STANDARD_ERROR_OF_MEAN|0.526||0.467|TWO_SIDED|90.0|-1.27|0.5|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.50|-1.27|0.467
72549518|NCT00765648|144629118|SUPERIORITY_OR_OTHER|||||||0.18|TWO_SIDED|95.0|||||Chi-squared|||||||0.18
72549519|NCT00765648|144629119|SUPERIORITY_OR_OTHER|||||||0.11|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||0.11
72549520|NCT01062256|144629137|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.84||||0.216|TWO_SIDED|95.0|0.64|1.1||p-values calculated from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time) as the offset parameter.|Poisson regression model|||Pairwise comparison of number of cough bouts over 4-hour postdose period.||1.10|0.64|0.216
72549521|NCT01062256|144629137|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.92||||0.513|TWO_SIDED|95.0|0.72|1.18||p-values calculated from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time) as the offset parameter.|Poisson regression model|||Pairwise comparison of number of cough bouts over 4-hour postdose period.||1.18|0.72|0.513
72549522|NCT01062256|144629137|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.09||||0.459|TWO_SIDED|95.0|0.87|1.38||p-values calculated from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time) as the offset parameter.|Poisson regression model|||Pairwise comparison of number of cough bouts over 4-hour postdose period.||1.38|0.87|0.459
72549523|NCT01062256|144629138|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.84||||0.195|TWO_SIDED|95.0|0.65|1.09||p-values calculated from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time) as the offset parameter.|Poisson regression model|||Pairwise comparison of number of cough bouts over 2-hour postdose period.||1.09|0.65|0.195
72549524|NCT01062256|144629138|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.91||||0.438|TWO_SIDED|95.0|0.71|1.16||p-values calculated from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site and baseline of cough bouts terms with log(exposure time)as the offset parameter.|Poisson regression model|||Pairwise comparison of number of cough bouts over 2-hour postdose period.||1.16|0.71|0.438
72549525|NCT01062256|144629138|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.08||||0.497|TWO_SIDED|95.0|0.87|1.34||p-values calculated from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site and baseline of cough bouts terms with log(exposure time)as the offset parameter.|Poisson regression model|||Pairwise comparison of number of cough bouts over 2-hour postdose period.||1.34|0.87|0.497
72549526|NCT01062256|144629139|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.85||||0.25|TWO_SIDED|95.0|0.64|1.12||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts within 15 minutes postdose||1.12|0.64|0.250
72549527|NCT01062256|144629139|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.97||||0.802|TWO_SIDED|95.0|0.75|1.25||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts within 15 minutes postdose||1.25|0.75|0.802
72412717|NCT01159938|144333509|SUPERIORITY_OR_OTHER||LS Mean Difference|0.03||||0.957|TWO_SIDED|95.0|-1.27|1.34||P-value is for LS mean difference (high minus low postprandial glucose) in PWV at 60-min post-breakfast in aortic arteries. Significance was assessed at the 2-sided 5% level.|ANCOVA|||||1.34|-1.27|0.957
72412718|NCT01159938|144333509|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.41||||0.513|TWO_SIDED|95.0|-1.68|0.85||P-value is for LS mean difference (high minus low postprandial glucose) in PWV at 60-min post-breakfast in aortic arteries. Significance was assessed at the 2-sided 5% level.|ANCOVA|||||0.85|-1.68|0.513
72412719|NCT01159938|144333509|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.09||||0.623|TWO_SIDED|95.0|-0.47|0.28||P-value is for LS mean difference (high minus low postprandial glucose) in PWV at 60-min post-breakfast in brachial arteries. Significance was assessed at the 2-sided 5% level.|ANCOVA|||||0.28|-0.47|0.623
72549528|NCT01062256|144629139|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.14||||0.188|TWO_SIDED|95.0|0.94|1.39||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts within 15 minutes postdose||1.39|0.94|0.188
72412720|NCT01159938|144333509|SUPERIORITY_OR_OTHER||LS Mean Difference|0.03||||0.916|TWO_SIDED|95.0|-0.51|0.57||P-value is for LS mean difference (high minus low postprandial glucose) in PWV at 60-min post-breakfast in brachial arteries. Significance was assessed at the 2-sided 5% level.|ANCOVA|||||0.57|-0.51|0.916
72549529|NCT01062256|144629139|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.78||||0.091|TWO_SIDED|95.0|0.58|1.04||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 15 and 30 minutes postdose||1.04|0.58|0.091
72549530|NCT01062256|144629139|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.9||||0.465|TWO_SIDED|95.0|0.69|1.19||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 15 and 30 minutes postdose||1.19|0.69|0.465
72549531|NCT01062256|144629139|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.16||||0.207|TWO_SIDED|95.0|0.92|1.46||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 15 and 30 minutes postdose||1.46|0.92|0.207
72549532|NCT01062256|144629139|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.81||||0.122|TWO_SIDED|95.0|0.62|1.06||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 30 and 45 minutes postdose||1.06|0.62|0.122
72549533|NCT01062256|144629139|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.84||||0.165|TWO_SIDED|95.0|0.66|1.07||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 30 and 45 minutes postdose||1.07|0.66|0.165
72549534|NCT01062256|144629139|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.04||||0.711|TWO_SIDED|95.0|0.83|1.32||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 30 and 45 minutes postdose||1.32|0.83|0.711
72549535|NCT01062256|144629139|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.84||||0.215|TWO_SIDED|95.0|0.64|1.11||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 45 and 60 minutes postdose||1.11|0.64|0.215
72549536|NCT01062256|144629139|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.88||||0.367|TWO_SIDED|95.0|0.67|1.16||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 45 and 60 minutes postdose||1.16|0.67|0.367
72549537|NCT01062256|144629139|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.05||||0.687|TWO_SIDED|95.0|0.82|1.35||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 45 and 60 minutes postdose||1.35|0.82|0.687
72549538|NCT01062256|144629139|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.94||||0.73|TWO_SIDED|95.0|0.67|1.32||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 60 and 75 minutes postdose||1.32|0.67|0.730
72549539|NCT01062256|144629139|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.02||||0.923|TWO_SIDED|95.0|0.74|1.39||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 60 and 75 minutes postdose||1.39|0.74|0.923
72412721|NCT01159938|144333509|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.21||||0.413|TWO_SIDED|95.0|-0.73|0.31||P-value is for LS mean difference (high minus low postprandial glucose) in PWV at 60-min post-breakfast in brachial arteries. Significance was assessed at the 2-sided 5% level.|ANCOVA|||||0.31|-0.73|0.413
72549540|NCT01062256|144629139|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.08||||0.573|TWO_SIDED|95.0|0.83|1.4||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 60 and 75 minutes postdose||1.40|0.83|0.573
72549541|NCT01062256|144629139|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.84||||0.289|TWO_SIDED|95.0|0.61|1.16||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 75 and 90 minutes postdose||1.16|0.61|0.289
72549542|NCT01062256|144629139|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.87||||0.379|TWO_SIDED|95.0|0.64|1.18||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 75 and 90 minutes postdose||1.18|0.64|0.379
72549543|NCT01062256|144629139|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.04||||0.785|TWO_SIDED|95.0|0.79|1.37||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 75 and 90 minutes postdose||1.37|0.79|0.785
72549544|NCT01062256|144629139|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.82||||0.194|TWO_SIDED|95.0|0.6|1.11||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 90 and 105 minutes postdose||1.11|0.60|0.194
72549545|NCT01062256|144629139|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.83||||0.212|TWO_SIDED|95.0|0.62|1.11||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 90 and 105 minutes postdose||1.11|0.62|0.212
72549546|NCT01062256|144629139|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.02||||0.901|TWO_SIDED|95.0|0.77|1.34||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 90 and 105 minutes postdose||1.34|0.77|0.901
72549547|NCT01062256|144629139|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.93||||0.6|TWO_SIDED|95.0|0.7|1.23||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 105 and 120 minutes postdose||1.23|0.70|0.600
72582746|NCT01217112|144695781|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.64|STANDARD_ERROR_OF_MEAN|0.406||0.124|TWO_SIDED|90.0|-1.32|0.05|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.05|-1.32|0.124
72582747|NCT01217112|144695781|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.439||0.909|TWO_SIDED|90.0|-0.68|0.79|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.79|-0.68|0.909
72582748|NCT01217112|144695781|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.46|STANDARD_ERROR_OF_MEAN|0.392||0.245|TWO_SIDED|90.0|-1.12|0.2|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.20|-1.12|0.245
72549548|NCT01062256|144629139|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.97||||0.853|TWO_SIDED|95.0|0.74|1.29||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 105 and 120 minutes postdose||1.29|0.74|0.853
72412722|NCT01159938|144333510|SUPERIORITY_OR_OTHER||LS Mean Difference|0.2||||0.724|TWO_SIDED|95.0|-0.94|1.34||P-value is for LS mean difference (high minus low postprandial glucose) in PWV at 120-min post-breakfast in aortic arteries. Significance was assessed at the 2-sided 5% level.|ANCOVA|||||1.34|-0.94|0.724
72549549|NCT01062256|144629139|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.05||||0.736|TWO_SIDED|95.0|0.79|1.39||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 105 and 120 minutes postdose||1.39|0.79|0.736
72549550|NCT01062256|144629139|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.95||||0.744|TWO_SIDED|95.0|0.7|1.3||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 120 and 135 minutes postdose||1.30|0.70|0.744
72549551|NCT01062256|144629139|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.98||||0.904|TWO_SIDED|95.0|0.72|1.33||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 120 and 135 minutes postdose||1.33|0.72|0.904
72412723|NCT01159938|144333510|SUPERIORITY_OR_OTHER||LS Mean Difference|0.57||||0.479|TWO_SIDED|95.0|-1.05|2.2||P-value is for LS mean difference (high minus low postprandial glucose) in PWV at 120-min post-breakfast in aortic arteries. Significance was assessed at 2-sided 5% level.|ANCOVA|||||2.20|-1.05|0.479
72549552|NCT01062256|144629139|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.03||||0.828|TWO_SIDED|95.0|0.77|1.39||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 120 and 135 minutes postdose||1.39|0.77|0.828
72549553|NCT01062256|144629139|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.8||||0.147|TWO_SIDED|95.0|0.59|1.08||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 135 and 150 minutes postdose||1.08|0.59|0.147
72549554|NCT01062256|144629139|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.87||||0.345|TWO_SIDED|95.0|0.65|1.16||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 135 and 150 minutes postdose||1.16|0.65|0.345
72549555|NCT01062256|144629139|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.09||||0.532|TWO_SIDED|95.0|0.83|1.44||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 135 and 150 minutes postdose||1.44|0.83|0.532
72549556|NCT01062256|144629139|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.83||||0.261|TWO_SIDED|95.0|0.61|1.15||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 150 and 165 minutes postdose||1.15|0.61|0.261
72549557|NCT01062256|144629139|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.92||||0.601|TWO_SIDED|95.0|0.69|1.24||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 150 and 165 minutes postdose||1.24|0.69|0.601
72549558|NCT01062256|144629139|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.11||||0.47|TWO_SIDED|95.0|0.84|1.47||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 150 and 165 minutes postdose||1.47|0.84|0.470
72549559|NCT01062256|144629139|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.97||||0.834|TWO_SIDED|95.0|0.71|1.32||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 165 and 180 minutes postdose||1.32|0.71|0.834
72549560|NCT01062256|144629139|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.07||||0.628|TWO_SIDED|95.0|0.81|1.43||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 165 and 180 minutes postdose||1.43|0.81|0.628
72549561|NCT01062256|144629139|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.11||||0.481|TWO_SIDED|95.0|0.83|1.48||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 165 and 180 minutes postdose||1.48|0.83|0.481
72549562|NCT01062256|144629139|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.94||||0.749|TWO_SIDED|95.0|0.65|1.37||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 180 and 195 minutes postdose||1.37|0.65|0.749
72549563|NCT01062256|144629139|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.97||||0.857|TWO_SIDED|95.0|0.7|1.35||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 180 and 195 minutes postdose||1.35|0.70|0.857
72549564|NCT01062256|144629139|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.03||||0.847|TWO_SIDED|95.0|0.76|1.41||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 180 and 195 minutes postdose||1.41|0.76|0.847
72549565|NCT01062256|144629139|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.77||||0.146|TWO_SIDED|95.0|0.54|1.09||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 195 and 210 minutes postdose||1.09|0.54|0.146
72549566|NCT01062256|144629139|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.94||||0.702|TWO_SIDED|95.0|0.69|1.29||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 195 and 210 minutes postdose||1.29|0.69|0.702
72549567|NCT01062256|144629139|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.22||||0.228|TWO_SIDED|95.0|0.88|1.69||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 195 and 210 minutes postdose||1.69|0.88|0.228
72412724|NCT01159938|144333510|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.18||||0.825|TWO_SIDED|95.0|-1.76|1.41||P-value is for LS mean difference (high minus low postprandial glucose) in PWV at 120-min post-breakfast in aortic arteries. Significance was assessed at 2-sided 5% level.|ANCOVA|||||1.41|-1.76|0.825
72412725|NCT01159938|144333510|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2||||0.378|TWO_SIDED|95.0|-0.65|0.25||P-value is for LS mean difference (high minus low postprandial glucose) in PWV at 120-min post-breakfast in brachial arteries. Significance was assessed at the 2-sided 5% level.|ANCOVA|||||0.25|-0.65|0.378
72582749|NCT01217112|144695781|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.36|STANDARD_ERROR_OF_MEAN|0.412||0.382|TWO_SIDED|90.0|-1.05|0.33|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.33|-1.05|0.382
72582750|NCT01217112|144695782|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.75|STANDARD_ERROR_OF_MEAN|0.837||0.376|TWO_SIDED|90.0|-2.15|0.66|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.66|-2.15|0.376
72582751|NCT01217112|144695782|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.37|STANDARD_ERROR_OF_MEAN|0.908||0.688|TWO_SIDED|90.0|-1.15|1.89|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||1.89|-1.15|0.688
72582752|NCT01217112|144695782|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.38|STANDARD_ERROR_OF_MEAN|0.803||0.637|TWO_SIDED|90.0|-1.73|0.96|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.96|-1.73|0.637
72582753|NCT01217112|144695782|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.79|STANDARD_ERROR_OF_MEAN|0.849||0.355|TWO_SIDED|90.0|-2.22|0.63|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.63|-2.22|0.355
72582754|NCT01217112|144695783|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.28|STANDARD_ERROR_OF_MEAN|0.391||0.482|TWO_SIDED|90.0|-0.39|0.95|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.95|-0.39|0.482
72582755|NCT01217112|144695783|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.19|STANDARD_ERROR_OF_MEAN|0.489||0.708|TWO_SIDED|90.0|-0.65|1.02|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||1.02|-0.65|0.708
72582756|NCT01217112|144695783|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.62|STANDARD_ERROR_OF_MEAN|0.434||0.166|TWO_SIDED|90.0|-0.12|1.37|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||1.37|-0.12|0.166
72582757|NCT01217112|144695783|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.33|STANDARD_ERROR_OF_MEAN|0.408||0.424|TWO_SIDED|90.0|-0.37|1.03|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||1.03|-0.37|0.424
72582758|NCT01217112|144695784|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.1|STANDARD_ERROR_OF_MEAN|1.26||0.022|TWO_SIDED|90.0|0.94|5.25|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||5.25|0.94|0.022
72582759|NCT01217112|144695784|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.07|STANDARD_ERROR_OF_MEAN|1.532||0.014|TWO_SIDED|90.0|1.44|6.69|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||6.69|1.44|0.014
72582760|NCT01217112|144695784|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.85|STANDARD_ERROR_OF_MEAN|1.4||0.053|TWO_SIDED|90.0|0.45|5.25|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||5.25|0.45|0.053
72582761|NCT01217112|144695784|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.56|STANDARD_ERROR_OF_MEAN|1.299||0.012|TWO_SIDED|90.0|1.33|5.78|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||5.78|1.33|0.012
72582762|NCT01217112|144695785|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.35|STANDARD_ERROR_OF_MEAN|1.463||0.032|TWO_SIDED|90.0|0.84|5.85|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||5.85|0.84|0.032
72582763|NCT01217112|144695785|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.27|STANDARD_ERROR_OF_MEAN|1.798||0.026|TWO_SIDED|90.0|1.18|7.35|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||7.35|1.18|0.026
72582764|NCT01217112|144695785|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.44|STANDARD_ERROR_OF_MEAN|1.626||0.046|TWO_SIDED|90.0|0.65|6.22|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||6.22|0.65|0.046
72412726|NCT01159938|144333510|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.19||||0.553|TWO_SIDED|95.0|-0.84|0.46||The p-value is for the LS mean difference (high minus low postprandial glucose) in PWV at 120 mins post-breakfast in brachial arteries. Significance was assessed at the 2-sided 5% level.|ANCOVA|||||0.46|-0.84|0.553
72412727|NCT01159938|144333510|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2||||0.512|TWO_SIDED|95.0|-0.83|0.42||P-value is for LS mean difference (high minus low postprandial glucose) in PWV at 120-min post-breakfast in brachial arteries. Significance was assessed at the 2-sided 5% level.|ANCOVA|||||0.42|-0.83|0.512
72412728|NCT01159938|144333511|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.29||||0.466|TWO_SIDED|95.0|-1.09|0.51||P-value is for LS mean difference (high minus low postprandial glucose) in PWV at 180-min post-breakfast in aortic arteries. Significance was assessed at the 2-sided 5% level.|ANCOVA|||||0.51|-1.09|0.466
72549568|NCT01062256|144629139|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.75||||0.13|TWO_SIDED|95.0|0.51|1.09||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 210 and 225 minutes postdose||1.09|0.51|0.130
72549569|NCT01062256|144629139|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.85||||0.371|TWO_SIDED|95.0|0.6|1.21||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 210 and 225 minutes postdose||1.21|0.60|0.371
72549570|NCT01062256|144629139|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.14||||0.43|TWO_SIDED|95.0|0.82|1.58||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 210 and 225 minutes postdose||1.58|0.82|0.430
72549571|NCT01062256|144629139|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.76||||0.177|TWO_SIDED|95.0|0.51|1.13||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 225 and 240 minutes postdose||1.13|0.51|0.177
72549572|NCT01062256|144629139|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.91||||0.58|TWO_SIDED|95.0|0.64|1.28||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 225 and 240 minutes postdose||1.28|0.64|0.580
72549573|NCT01062256|144629139|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.19||||0.333|TWO_SIDED|95.0|0.84|1.7||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 225 and 240 minutes postdose||1.70|0.84|0.333
72549574|NCT01062256|144629140|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||0.264|TWO_SIDED|95.0|-0.08|0.27||p-values from ANOVA model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), and site terms.|ANOVA|||Pairwise comparison of change from baseline in cough severity at 1 hour postdose||0.27|-0.08|0.264
72582765|NCT01217112|144695785|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.86|STANDARD_ERROR_OF_MEAN|1.512||0.018|TWO_SIDED|90.0|1.26|6.45|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||6.45|1.26|0.018
72582766|NCT01217112|144695786|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.87|STANDARD_ERROR_OF_MEAN|0.806||0.294|TWO_SIDED|90.0|-0.52|2.25|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||2.25|-0.52|0.294
72549575|NCT01062256|144629140|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.03||||0.737|TWO_SIDED|95.0|-0.2|0.14||p-values from ANOVA model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), and site terms.|ANOVA|||Pairwise comparison of change from baseline in cough severity at 1 hour postdose||0.14|-0.20|0.737
72549576|NCT01062256|144629140|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.13||||0.078|TWO_SIDED|95.0|-0.27|0.01||p-values from ANOVA model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), and site terms.|ANOVA|||Pairwise comparison of change from baseline in cough severity at 1 hour postdose||0.01|-0.27|0.078
72549577|NCT01062256|144629140|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.16||||0.125|TWO_SIDED|95.0|-0.04|0.36||p-values from ANOVA model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), and site terms.|ANOVA|||Pairwise comparison of change from baseline in cough severity at 2 hour postdose||0.36|-0.04|0.125
72412729|NCT01159938|144333511|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.44||||0.449|TWO_SIDED|95.0|-1.6|0.72||P-value is for LS mean difference (high minus low postprandial glucose) in PWV at 180-min post-breakfast in aortic arteries. Significance was assessed at the 2-sided 5% level.|ANCOVA|||||0.72|-1.60|0.449
72549578|NCT01062256|144629140|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.04||||0.688|TWO_SIDED|95.0|-0.16|0.24||p-values from ANOVA model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), and site terms.|ANOVA|||Pairwise comparison of change from baseline in cough severity at 2 hour postdose||0.24|-0.16|0.688
72412730|NCT01159938|144333511|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.15||||0.792|TWO_SIDED|95.0|-1.25|0.96||P-value is for LS mean difference (high minus low postprandial glucose) in PWV at 180-min post-breakfast in aortic arteries. Significance was assessed at the 2-sided 5% level.|ANCOVA|||||0.96|-1.25|0.792
72412731|NCT01159938|144333511|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.16||||0.493|TWO_SIDED|95.0|-0.63|0.31||P-value is for LS mean difference (high minus low postprandial glucose) in PWV at 180-min post-breakfast in brachial arteries. Significance was assessed at the 2-sided 5% level.|ANCOVA|||||0.31|-0.63|0.493
72412732|NCT01159938|144333511|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.58||||0.091|TWO_SIDED|95.0|-1.25|0.1||P-value is for LS mean difference (high minus low postprandial glucose) in PWV at 180-min post-breakfast in brachial arteries. Significance was assessed at the 2-sided 5% level.|ANCOVA|||||0.10|-1.25|0.091
72412733|NCT01159938|144333511|SUPERIORITY_OR_OTHER||LS Mean Difference|0.26||||0.425|TWO_SIDED|95.0|-0.39|0.9||P-value is for LS mean difference (high minus low postprandial glucose) in PWV at 180-min post-breakfast in brachial arteries. Significance was assessed at the 2-sided 5% level.|ANCOVA|||||0.90|-0.39|0.425
72412734|NCT01159938|144333512|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.48||||0.275|TWO_SIDED|95.0|-1.36|0.4||P-value is for LS mean difference (high minus low postprandial glucose) in PWV at 240-min post-breakfast in aortic arteries. Significance was assessed at the 2-sided 5% level.|ANCOVA|||||0.40|-1.36|0.275
72549579|NCT01062256|144629140|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.12||||0.166|TWO_SIDED|95.0|-0.29|0.05||p-values from ANOVA model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), and site terms.|ANOVA|||Pairwise comparison of change from baseline in cough severity at 2 hour postdose||0.05|-0.29|0.166
72549580|NCT01062256|144629140|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.13||||0.233|TWO_SIDED|95.0|-0.09|0.35||p-values from ANOVA model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), and site terms.|ANOVA|||Pairwise comparison of change from baseline in cough severity at 3 hour postdose||0.35|-0.09|0.233
72549581|NCT01062256|144629140|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02||||0.848|TWO_SIDED|95.0|-0.24|0.19||p-values from ANOVA model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), and site terms.|ANOVA|||Pairwise comparison of change from baseline in cough severity at 3 hour postdose||0.19|-0.24|0.848
72549582|NCT01062256|144629140|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.15||||0.093|TWO_SIDED|95.0|-0.33|0.03||p-values from ANOVA model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), and site terms.|ANOVA|||Pairwise comparison of change from baseline in cough severity at 3 hour postdose||0.03|-0.33|0.093
72549583|NCT01062256|144629140|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||0.406|TWO_SIDED|95.0|-0.14|0.34||p-values from ANOVA model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), and site terms.|ANOVA|||Pairwise comparison of change from baseline in cough severity at 4 hour postdose||0.34|-0.14|0.406
72549584|NCT01062256|144629140|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.991|TWO_SIDED|95.0|-0.24|0.24||p-values from ANOVA model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), and site terms.|ANOVA|||Pairwise comparison of change from baseline in cough severity at 4 hour postdose||0.24|-0.24|0.991
72549585|NCT01062256|144629140|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.306|TWO_SIDED|95.0|-0.3|0.09||p-values from ANOVA model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), and site terms.|ANOVA|||Pairwise comparison of change from baseline in cough severity at 4 hour postdose||0.09|-0.30|0.306
72549586|NCT01062256|144629141|SUPERIORITY_OR_OTHER||Goodman-Kruskal Gamma statistic|0.15||||0.254|TWO_SIDED|95.0|-0.09|0.39||p-values from Cochran-Mantel-Haenszel test with modified ridit scores, controlling for gender, time stratum, and site.|Cochran-Mantel-Haenszel|||Pairwise comparison of global evaluation of study medication.||0.39|-0.09|0.254
72549587|NCT01062256|144629141|SUPERIORITY_OR_OTHER||weighted Goodman-Kruskal Gamma statistic|-0.01||||0.949|TWO_SIDED|95.0|-0.25|0.23||p-values from Cochran-Mantel-Haenszel test with modified ridit scores, controlling for gender, time stratum, and site.|Cochran-Mantel-Haenszel|||Pairwise comparison of global evaluation of study medication.||0.23|-0.25|0.949
72549588|NCT01062256|144629141|SUPERIORITY_OR_OTHER||weighted Goodman-Kruskal Gamma statistic|-0.12||||0.256|TWO_SIDED|95.0|-0.32|0.08||p-values from Cochran-Mantel-Haenszel test with modified ridit scores, controlling for gender, time stratum, and site.|Cochran-Mantel-Haenszel|||Pairwise comparison of global evaluation of study medication.||0.08|-0.32|0.256
72412735|NCT01159938|144333512|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.17||||0.784||95.0|-1.44|1.1||P-value is for LS mean difference (high minus low postprandial glucose) in PWV at 240-min post-breakfast in aortic arteries. Significance was assessed at the 2-sided 5% level.|ANCOVA|||||1.10|-1.44|0.784
72412736|NCT01159938|144333512|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.79||||0.197|TWO_SIDED|95.0|-2.01|0.43||P-value is for LS mean difference (high minus low postprandial glucose) in PWV at 240-min post-breakfast in aortic arteries. Significance was assessed at the 2-sided 5% level.|ANCOVA|||||0.43|-2.01|0.197
72412737|NCT01159938|144333512|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4||||0.122|TWO_SIDED|95.0|-0.9|0.11||P-value is for LS mean difference (high minus low postprandial glucose) in PWV at 240-min post-breakfast in brachial arteries. Significance was assessed at the 2-sided 5% level.|ANCOVA|||||0.11|-0.90|0.122
72549589|NCT00891293|144629163|SUPERIORITY_OR_OTHER||Median Difference (Net)|3.3|STANDARD_DEVIATION|29.01||0.9999||95.0|-2.8|9.4|||ANOVA||Difference Between Percent Change from LOV111859/OM5 Baseline to LOV111860/OM5X End-of-Treatment and Percent Change from LOV111859/OM5 Baseline to LOV111821/OM5XX End-of-Treatment|For the MITT analysis, the method of last observation carried forward (LOCF) was applied. The LOCF is the value of a previous non-baseline visit (post-enrollment) carried forward to the subsequent visit, if missing.||9.4|-2.8|0.9999
72549590|NCT02809183|144629241|OTHER|Single-group test|Group LS mean|-0.2|STANDARD_ERROR_OF_MEAN|0.4||0.5547|TWO_SIDED|95.0|-0.9|0.5||The null hypothesis is that the mean change from baseline within the Pooled Placebo treatment group = 0 mEq/L.|Mixed Models Analysis|||||0.5|-0.9|0.5547
72549591|NCT02809183|144629241|OTHER|Single-group test|Group LS mean|3.2|STANDARD_ERROR_OF_MEAN|0.4|<|0.0001|TWO_SIDED|95.0|2.4|4.0||The null hypothesis is that the mean change from baseline within the 1.5g TRC101 BID group = 0 mEq/L|Mixed Models Analysis|||The null hypothesis is that the mean change from baseline within the 1.5g TRC101 BID treatment group = 0 mEq/L.||4.0|2.4|< 0.0001
72549592|NCT02809183|144629241|OTHER|Single-group test|Group LS mean|3.0|STANDARD_ERROR_OF_MEAN|0.4|<|0.0001|TWO_SIDED|95.0|2.2|3.8||The null hypothesis is the 3g TRC101 BID treatment group mean change from baseline = 0 mEq/L.|Mixed Models Analysis|||||3.8|2.2|< 0.0001
72549593|NCT02809183|144629241|OTHER|Single-group test|Group LS mean|3.7|STANDARD_ERROR_OF_MEAN|0.4|<|0.0001|TWO_SIDED|95.0|2.9|4.5||The null hypothesis is the 4.5g TRC101 BID treatment group mean change from baseline = 0 mEq/L|Mixed Models Analysis|||||4.5|2.9|< 0.0001
72549594|NCT02809183|144629242|OTHER|Two-group test|Difference between group LS means|3.4|STANDARD_ERROR_OF_MEAN|0.5|<|0.0001|TWO_SIDED|95.0|2.3|4.5||The null hypothesis is the difference between treatment groups (1.5g TRC101 BID - Pooled Placebo) in the mean change from baseline = 0 mEq/L.|Mixed Models Analysis|||||4.5|2.3|< 0.0001
72549595|NCT02809183|144629242|OTHER|Two-group test|Difference between group LS means|3.2|STANDARD_ERROR_OF_MEAN|0.5|<|0.0001|TWO_SIDED|95.0|2.2|4.3||The null hypothesis is the difference between treatment groups (3g TRC101 BID - Pooled Placebo) in the mean change from baseline = 0 mEq/L.|Mixed Models Analysis|||||4.3|2.2|< 0.0001
72549596|NCT02809183|144629242|OTHER|Two-group test|Difference between group LS means|3.9|STANDARD_ERROR_OF_MEAN|0.5|<|0.0001|TWO_SIDED|95.0|2.9|5.0||The null hypothesis is the difference between the treatment groups (4.5g TRC101 BID - Pooled Placebo) in the mean change from baseline = 0 mEq/L.|Mixed Models Analysis|||||5.0|2.9|< 0.0001
72582767|NCT01217112|144695786|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.74|STANDARD_ERROR_OF_MEAN|0.988||0.092|TWO_SIDED|90.0|0.05|3.43|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||3.43|0.05|0.092
72549597|NCT02809183|144629243|OTHER|Single-group test|Group LS mean|3.3|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001|TWO_SIDED|95.0|3.0|3.7||The null hypothesis is that the mean change from baseline within the Combined TRC101 treatment group = 0 mEq/L.|Mixed Models Analysis|||||3.7|3.0|< 0.0001
72412738|NCT01159938|144333512|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.43||||0.246|TWO_SIDED|95.0|-1.16|0.31||P-value is for LS mean difference (high minus low postprandial glucose) in PWV at 240-min post-breakfast in brachial arteries. Significance was assessed at the 2-sided 5% level.|ANCOVA|||||0.31|-1.16|0.246
72412739|NCT01159938|144333512|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.37||||0.298|TWO_SIDED|95.0|-1.06|0.33||P-value is for LS mean difference (high minus low postprandial glucose) in PWV at 240-min post-breakfast in brachial arteries. Significance was assessed at the 2-sided 5% level.|ANCOVA|||||0.33|-1.06|0.298
72412740|NCT01159938|144333513|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.49||||0.024|TWO_SIDED|95.0|-6.5|-0.48||P-value is for the Least Square (LS) mean difference (high minus low postprandial glucose) in change in PWA at 60-min post-breakfast. Significance was assessed at the 2-sided 5% level.|ANCOVA|LS mean was adjusted for age, body mass index (BMI), visit, group, condition, group by condition, and random participant.||||-0.48|-6.50|0.024
72549598|NCT02809183|144629244|OTHER|Two-group test|Difference between group LS means|3.6|STANDARD_ERROR_OF_MEAN|0.4|<|0.0001|TWO_SIDED|95.0|2.8|4.4||The null hypothesis is that the difference between treatment groups (Combined TRC101 - Pooled Placebo) in the mean change from baseline = 0 mEq/L.|Mixed Models Analysis|||||4.4|2.8|< 0.0001
72549599|NCT02809183|144629245|OTHER|Two-group test|||||<|0.0001||||||The null hypothesis is that the difference between treatment groups (1.5g TRC101 BID - Pooled Placebo) in proportion of subjects whose serum bicarbonate increased from baseline to Day 15 by =\> 2 mEq/L = 0.|Fisher Exact|||||||< 0.0001
72549600|NCT02809183|144629245|OTHER|Two-group test|||||<|0.0001||||||The null hypothesis is that the difference between treatment groups (1.5g TRC101 BID - Pooled Placebo) in proportion of subjects whose serum bicarbonate increased from baseline to Day 15 by =\> 3 mEq/L = 0.|Fisher Exact|||||||< 0.0001
72549601|NCT02809183|144629245|OTHER|Two-group test||||||0.0074||||||The null hypothesis is that the difference between treatment groups (1.5g TRC101 BID - Pooled Placebo) in proportion of subjects whose serum bicarbonate increased from baseline to Day 15 by =\> 4 mEq/L = 0.|Fisher Exact|||||||0.0074
72549602|NCT02809183|144629245|OTHER|Two-group test||||||0.0012||||||The null hypothesis is that the difference between treatment groups (3g TRC101 BID - Pooled Placebo) in proportion of subjects whose serum bicarbonate increased from baseline to Day 15 by =\> 2 mEq/L = 0.|Fisher Exact|||||||0.0012
72549603|NCT02809183|144629245|OTHER|Two-group test||||||0.0032||||||The null hypothesis is that the difference between treatment groups (3g TRC101 BID - Pooled Placebo) in proportion of subjects whose serum bicarbonate increased from baseline to Day 15 by =\> 3 mEq/L = 0.|Fisher Exact|||||||0.0032
72549604|NCT02809183|144629245|OTHER|Two-group test||||||0.0013||||||The null hypothesis is that the difference between treatment groups (3g TRC101 BID - Pooled Placebo) in proportion of subjects whose serum bicarbonate increased from baseline to Day 15 by =\> 4 mEq/L = 0.|Fisher Exact|||||||0.0013
72549605|NCT02809183|144629245|OTHER|Two-group test|||||<|0.0001||||||The null hypothesis is that the difference between treatment groups (4.5g TRC101 BID - Pooled Placebo) in proportion of subjects whose serum bicarbonate increased from baseline to Day 15 by =\> 2 mEq/L = 0.|Fisher Exact|||||||< 0.0001
72549606|NCT02809183|144629245|OTHER|Two-group test|||||<|0.0001||||||The null hypothesis is that the difference between treatment groups (4.5g TRC101 BID - Pooled Placebo) in proportion of subjects whose serum bicarbonate increased from baseline to Day 15 by =\> 3 mEq/L = 0.|Fisher Exact|||||||< 0.0001
72549607|NCT02809183|144629245|OTHER|Two-group test|||||<|0.0006||||||The null hypothesis is that the difference between treatment groups (4.5g TRC101 BID - Pooled Placebo) in proportion of subjects whose serum bicarbonate increased from baseline to Day 15 by =\> 4 mEq/L = 0.|Fisher Exact|||||||< 0.0006
72582768|NCT01217112|144695786|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.26|STANDARD_ERROR_OF_MEAN|0.893||0.173|TWO_SIDED|90.0|-0.28|2.79|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||2.79|-0.28|0.173
72582769|NCT01217112|144695786|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.51|STANDARD_ERROR_OF_MEAN|0.837||0.545|TWO_SIDED|90.0|-0.92|1.95|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||1.95|-0.92|0.545
72582770|NCT01217112|144695787|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.67|STANDARD_ERROR_OF_MEAN|1.214||0.038|TWO_SIDED|90.0|0.59|4.75|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||4.75|0.59|0.038
72582771|NCT01217112|144695787|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.71|STANDARD_ERROR_OF_MEAN|1.486||0.004|TWO_SIDED|90.0|2.16|7.26|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||7.26|2.16|0.004
72582772|NCT01217112|144695787|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.4|STANDARD_ERROR_OF_MEAN|1.35||0.088|TWO_SIDED|90.0|0.09|4.72|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||4.72|0.09|0.088
72582773|NCT01217112|144695787|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.54|STANDARD_ERROR_OF_MEAN|1.252||0.01|TWO_SIDED|90.0|1.39|5.68|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||5.68|1.39|0.010
72549608|NCT02809183|144629246|OTHER|Single-group test|Group LS mean|3.5|STANDARD_ERROR_OF_MEAN|0.4|<|0.0001|TWO_SIDED|95.0|2.7|4.2||The null hypothesis is that the mean change from baseline within the 6g TRC101 QD group = 0 mEq/L.|Mixed Models Analysis|||||4.2|2.7|<0.0001
72549609|NCT02809183|144629247|OTHER|Two-group test|Difference between group LS means|3.7|STANDARD_ERROR_OF_MEAN|0.5|<|0.0001|TWO_SIDED|95.0|2.6|4.7||The null hypothesis is the difference between treatment groups (6g TRC101 QD - Pooled Placebo) in the mean change from baseline = 0 mEq/L.|Mixed Models Analysis|||||4.7|2.6|<0.0001
72549610|NCT02809183|144629248|OTHER|Two-group test|Difference between group LS means|-0.5|STANDARD_ERROR_OF_MEAN|0.6||0.4214|TWO_SIDED|95.0|-1.6|0.7||The null hypothesis is that the difference between treatment groups (3g TRC101 BID - 6g TRC101 QD) in the mean change from baseline = 0 mEq/L.|Mixed Models Analysis|||||0.7|-1.6|0.4214
72549611|NCT02809183|144629249|OTHER|Two-group test|||||<|0.0001||||||The null hypothesis is that the difference between treatment groups (6g TRC101 QD - Pooled Placebo) in proportion of subjects whose serum bicarbonate increased from baseline to Day 15 by =\> 2 mEq/L = 0.|Fisher Exact|||||||< 0.0001
72549612|NCT02809183|144629249|OTHER|Two-group test||||||0.0003||||||The null hypothesis is that the difference between treatment groups (6g TRC101 QD - Pooled Placebo) in the proportion of subjects whose serum bicarbonate increased from baseline to Day 15 by =\> 3 mEq/L = 0.|Fisher Exact|||||||0.0003
72549613|NCT02809183|144629249|OTHER|Two-group test||||||0.0003||||||The null hypothesis is that the difference between treatment groups (6g TRC101 QD - Pooled Placebo) in the proportion of subjects whose serum bicarbonate increased from baseline to Day 15 by =\> 4 mEq/L = 0.|Fisher Exact|||||||0.0003
72549614|NCT01430741|144629262|SUPERIORITY_OR_OTHER||||||=|0.04|||||||Mixed Models Analysis|||Compared changes in service intensity among Veterans served by case managers in the GTO group relative to the comparison group of Veterans, by fitting a series of mixed-effects regression models. Final mixed-effect models for all outcomes included fixed terms for group (GTO group vs. comparison), time, group x time interaction as well as control covariates.||||=.04
72549615|NCT01430741|144629263|SUPERIORITY_OR_OTHER||||||=|0.21|||||||Mixed Models Analysis|||Compared changes in alcohol dependence among Veterans served by case managers in the GTO group relative to the comparison group of Veterans, by fitting a series of mixed-effects regression models. Final mixed-effect models for all outcomes included fixed terms for group (GTO group vs. comparison), time, group x time interaction as well as control covariates.||||=.21
72582774|NCT01217112|144695788|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.53|STANDARD_ERROR_OF_MEAN|1.814||0.064|TWO_SIDED|90.0|0.42|6.64|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||6.64|0.42|0.064
72412741|NCT01159938|144333513|SUPERIORITY_OR_OTHER||LS Mean Difference|0.25||||0.859|TWO_SIDED|95.0|-2.59|3.09||P-value is for LS mean difference (high minus low postprandial glucose) in change in PWA at 60-min post-breakfast. Significance was assessed at the 2-sided 5% level.|ANCOVA|The LS mean was adjusted for age, BMI, visit, group, condition, group by condition, and random participant.||||3.09|-2.59|0.859
72582775|NCT01217112|144695788|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|6.55|STANDARD_ERROR_OF_MEAN|2.237||0.008|TWO_SIDED|90.0|2.72|10.38|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||10.38|2.72|0.008
72582776|NCT01217112|144695788|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.65|STANDARD_ERROR_OF_MEAN|2.016||0.084|TWO_SIDED|90.0|0.19|7.1|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||7.10|0.19|0.084
72582777|NCT01217112|144695788|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.05|STANDARD_ERROR_OF_MEAN|1.871||0.041|TWO_SIDED|90.0|0.84|7.25|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||7.25|0.84|0.041
72582778|NCT01217112|144695789|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.07|STANDARD_ERROR_OF_MEAN|0.044||0.129|TWO_SIDED|90.0|-0.14|0.01|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.01|-0.14|0.129
72582779|NCT01217112|144695789|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.051||0.961|TWO_SIDED|90.0|-0.08|0.09|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.09|-0.08|0.961
72582780|NCT01217112|144695789|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.08|STANDARD_ERROR_OF_MEAN|0.048||0.128|TWO_SIDED|90.0|-0.16|0.01|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.01|-0.16|0.128
72582781|NCT01217112|144695789|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.045||0.3|TWO_SIDED|90.0|-0.12|0.03|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.03|-0.12|0.300
72582782|NCT01217112|144695790|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.65|STANDARD_ERROR_OF_MEAN|5.38||0.625|TWO_SIDED|90.0|-6.37|11.67|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||11.67|-6.37|0.625
72582783|NCT01217112|144695790|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|6.77|STANDARD_ERROR_OF_MEAN|5.519||0.226|TWO_SIDED|90.0|-2.48|16.02|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||16.02|-2.48|0.226
72582784|NCT01217112|144695790|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.62|STANDARD_ERROR_OF_MEAN|5.103||0.904|TWO_SIDED|90.0|-7.94|9.18|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||9.18|-7.94|0.904
72582785|NCT01217112|144695790|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|6.17|STANDARD_ERROR_OF_MEAN|5.71||0.285|TWO_SIDED|90.0|-3.41|15.75|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||15.75|-3.41|0.285
72582786|NCT01217112|144695791|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.85|STANDARD_ERROR_OF_MEAN|0.568||0.138|TWO_SIDED|90.0|-1.81|0.1|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.10|-1.81|0.138
72582787|NCT01217112|144695791|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.37|STANDARD_ERROR_OF_MEAN|0.547||0.505|TWO_SIDED|90.0|-1.28|0.55|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.55|-1.28|0.505
72582788|NCT01217112|144695791|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.18|STANDARD_ERROR_OF_MEAN|0.54||0.743|TWO_SIDED|90.0|-0.73|1.08|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||1.08|-0.73|0.743
72582789|NCT01217112|144695791|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.35|STANDARD_ERROR_OF_MEAN|0.565||0.54|TWO_SIDED|90.0|-0.6|1.29|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||1.29|-0.60|0.540
72582790|NCT01217112|144695793|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.64|STANDARD_ERROR_OF_MEAN|1.664||0.701|TWO_SIDED|90.0|-2.14|3.43|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||3.43|-2.14|0.701
72582791|NCT01217112|144695793|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.77|STANDARD_ERROR_OF_MEAN|1.662||0.006|TWO_SIDED|90.0|1.99|7.55|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||7.55|1.99|0.006
72582792|NCT01217112|144695793|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.98|STANDARD_ERROR_OF_MEAN|1.589||0.542|TWO_SIDED|90.0|-1.68|3.64|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||3.64|-1.68|0.542
72582793|NCT01217112|144695793|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.36|STANDARD_ERROR_OF_MEAN|1.627||0.827|TWO_SIDED|90.0|-2.36|3.08|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||3.08|-2.36|0.827
72582794|NCT03192488|144695794|SUPERIORITY||Mean Difference (Final Values)|1.06||||0.047|TWO_SIDED|95.0|0.01|2.11|||ANOVA|"The overall model was adjusted for the co-variate VO2max."||||2.11|0.01|0.047
72549616|NCT01430741|144629263|SUPERIORITY_OR_OTHER||||||=|0.07|||||||Mixed Models Analysis|||Compared changes in drug dependence among Veterans served by case managers in the GTO group relative to the comparison group of Veterans, by fitting a series of mixed-effects regression models. Final mixed-effect models for all outcomes included fixed terms for group (GTO group vs. comparison), time, group x time interaction as well as control covariates.||||=.07
72549617|NCT01430741|144629264|SUPERIORITY_OR_OTHER||||||=|0.14|||||||Mixed Models Analysis|||Compared mental health inpatient hospitalizations among Veterans served by case managers in the GTO group relative to the comparison group of Veterans, by fitting a series of mixed-effects regression models. Final mixed-effect models for all outcomes included fixed terms for group (GTO group vs. comparison), time, group x time interaction as well as control covariates.||||=.14
72582795|NCT03192488|144695795|SUPERIORITY|||||||0.327|||||||ANOVA|||||||0.327
72582796|NCT03192488|144695795|SUPERIORITY|||||||0.557|||||||ANOVA|||||||0.557
72582797|NCT01366417|144695853|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|2.21|STANDARD_ERROR_OF_MEAN|0.133|<|0.05|TWO_SIDED|95.0|1.95|2.48|||ANOVA|||Hypothesis: ChloraPrep will meet or exceed the 1.0 log reduction in colony forming units/cm\^2 at 30 seconds after application.||2.48|1.95|< 0.05
72549618|NCT01430741|144629264|SUPERIORITY_OR_OTHER||||||=|0.19|||||||Mixed Models Analysis|||Compared medical inpatient hospitalizations among Veterans served by case managers in the GTO group relative to the comparison group of Veterans, by fitting a series of mixed-effects regression models. Final mixed-effect models for all outcomes included fixed terms for group (GTO group vs. comparison), time, group x time interaction as well as control covariates.||||=.19
72582798|NCT01366417|144695853|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|2.25|STANDARD_DEVIATION|0.133|<|0.05|TWO_SIDED|95.0|1.99|2.51|||ANOVA|||hypothesis: 70% Isopropyl Alcohol will meet or exceed 1.0 log 10 colony forming units / cm\^2 at 30 seconds after treatment||2.51|1.99|<0.05
72582799|NCT01366417|144695854|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|2.65|STANDARD_DEVIATION|0.133|<|0.05|TWO_SIDED|95.0|2.39|2.91|||ANOVA|||Hypothesis: ChloraPrep One Step will meet or exceed 2.0 log 10 reduction at 10 minutes after treatment.||2.91|2.39|<0.05
72582800|NCT01366417|144695854|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|2.6|STANDARD_DEVIATION|0.133|<|0.05|TWO_SIDED|95.0|2.33|2.86|||ANOVA|||Hypothesis: 70% Isopropyl Alcohol will meet or exceed 2.0 log 10 reduction at 10 minutes after treatment||2.86|2.33|<0.05
72582801|NCT01641640|144695856|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Binomial exact test|||Superiority would be demonstrated if the SVR12 rate was higher than the 60% null SVR rate based on historical control data.||||< 0.001
72582802|NCT01234350|144695862|OTHER||IRR|0.829||||0.4007|TWO_SIDED|95.0|0.536|1.283||Poisson-mixture regression was used to model the influence of age, stage of disease, and relevant medical history along with the treatment group effect on the number of events adjusted for individual study exposures measured in 100 PYE.|Wald test|The IRs for each treatment arm with 95% confidence interval (CI), and incidence rate ratio (IRRs) with 95% CI and p-values were based on Wald test.|IRR for treatment with the lower 95% confidence limit \>1 suggest increased risk of AESI; upper confidence limit \<1 suggest decreased risk of AESI with the use of FIRMAGON. The limit including 1 suggests no difference b/w treatment groups.|The IRs were estimated using a Poisson-mixture regression model.||1.283|0.536|0.4007
72549619|NCT01430741|144629265|SUPERIORITY_OR_OTHER||||||=|0.24|||||||Mixed Models Analysis|||Compared changes in mental health emergency department visits among Veterans served by case managers in the GTO group relative to the comparison group of Veterans, by fitting a series of mixed-effects regression models. Final mixed-effect models for all outcomes included fixed terms for group (GTO group vs. comparison), time, group x time interaction as well as control covariates.||||=.24
72549620|NCT01430741|144629266|SUPERIORITY_OR_OTHER||||||=|0.481|||||||Regression, Cox|||We used Kaplan-Meier survival curves to estimate the extent and timing of negative housing exits over time and Cox proportional hazards regression to assess the relationship between membership in the GTO group and risk of experiencing a negative housing exit, adjusting for a set of relevant covariates.||||=.481
72549621|NCT01226797|144629281|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.5834||||0.6668|TWO_SIDED|95.0|0.1|3.51|||Fisher Exact||Odds-ratio and confidence interval obtained from logistic regression with treatment as fixed effect|||3.51|0.10|0.6668
72549622|NCT01226797|144629282|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.1591||||0.155|TWO_SIDED|95.0|0.01|1.73|||Fisher Exact||Odds-ratio and confidence interval obtained from logistic regression with treatment as fixed effect.|||1.73|0.01|0.1550
72582803|NCT01234350|144695863|OTHER||IRR|0.874||||0.671|TWO_SIDED|95.0|0.47|1.626||Poisson-mixture regression was used to model the influence of age, stage of disease, and relevant medical history along with the treatment group effect on the number of events adjusted for individual study exposures measured in 100 PYE.|Wald test|The IRs for each treatment arm with 95% CI, and IRRs with 95% CI and p-values were based on Wald test.|IRR for treatment with the lower 95% confidence limit \>1 suggest increased risk of AESI; upper confidence limit \<1 suggest decreased risk of AESI with the use of FIRMAGON. The limit including 1 suggests no difference b/w treatment groups.|For osteoporosis and osteopenia events. The IRs were estimated using Poisson-mixture regression model.||1.626|0.470|0.6710
72582804|NCT01234350|144695863|OTHER||IRR|1.857||||0.4544|TWO_SIDED|95.0|0.367|9.403||Poisson-mixture regression was used to model the influence of age, stage of disease, and relevant medical history along with the treatment group effect on the number of events adjusted for individual study exposures measured in 100 PYE.|Wald test|The IRs for each treatment arm with 95% CI, and IRRs with 95% CI and p-values were based on Wald test.|IRR for treatment with the lower 95% confidence limit \>1 suggest increased risk of AESI; upper confidence limit \<1 suggest decreased risk of AESI with the use of FIRMAGON. The limit including 1 suggests no difference b/w treatment groups.|For bone fracture events. The IRs were estimated using Poisson-mixture regression model.||9.403|0.367|0.4544
72582805|NCT01234350|144695864|OTHER||IRR|1.193||||0.2529|TWO_SIDED|95.0|0.882|1.613||Poisson mixture regression was used to model the influence of age, stage of disease, and history of diabetes mellitus along with the treatment group effect on the number of events adjusted for individual study exposures measured in 100 PYE.|Wald test|The IRs for each treatment arm with 95% CI, and IRRs with 95% CI and p-values were based on Wald test.|IRR for treatment with the lower 95% confidence limit \>1 suggest increased risk of AESI; upper confidence limit \<1 suggest decreased risk of AESI with the use of FIRMAGON. The limit including 1 suggests no difference b/w treatment groups.|For glucose intolerance. The IRs were estimated using Poisson-mixture regression model.||1.613|0.882|0.2529
72582806|NCT01234350|144695864|OTHER||IRR|2.623||||0.0208|TWO_SIDED|95.0|1.158|5.944||Poisson-mixture regression is used to model the influence of age, stage of disease, and relevant medical history along with the treatment group effect on the number of events adjusted for individual trial exposures measured in 100 PYE.|Wald test|The IRs for each treatment arm with 95% CI, and IRRs with 95% CI and p-values were based on Wald test.|IRR for treatment with the lower 95% confidence limit \>1 suggest increased risk of AESI; upper confidence limit \<1 suggest decreased risk of AESI with the use of FIRMAGON. The limit including 1 suggests no difference b/w treatment groups.|For T2DM. The IRs were estimated using Poisson-mixture regression model.||5.944|1.158|0.0208
72582807|NCT01234350|144695871|OTHER||Odds Ratio (OR)|0.747||||0.0821|TWO_SIDED|95.0|0.537|1.038||A logistic regression was used to model the influence of age, stage of disease and relevant medical history along with the treatment group on the time to event for all-cause mortality.|Regression, Logistic|Logistic regression was used to model the influence of age, stage of disease and relevant medical history along with the treatment group.||The analyses of all-cause mortality was based on logistic regressions.||1.038|0.537|0.0821
72582808|NCT01839708|144695872|OTHER||||||>|0.05|||||||Mixed Models Analysis|||||||>0.05
72582809|NCT01839708|144695873|OTHER||||||>|0.05|||||||Mixed Models Analysis|||||||>0.05
72582810|NCT01839708|144695874|OTHER||||||<|0.05|||||||Mixed Models Analysis|||||||<0.05
72582811|NCT01839708|144695875|OTHER||||||>|0.05|||||||Mixed Models Analysis|||||||>0.05
72549623|NCT01226797|144629283|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|25.45||||0.1259|TWO_SIDED|95.0|-7.79|58.69||Treatment as fixed effect and baseline as covariate.|ANCOVA|||At Week 1||58.69|-7.79|0.1259
72549624|NCT01226797|144629283|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|13.49||||0.3297|TWO_SIDED|95.0|-14.67|41.66||Treatment as fixed effect and baseline as covariate.|ANCOVA|||At Week 2||41.66|-14.67|0.3297
72549625|NCT01226797|144629283|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|15.17||||0.3925|TWO_SIDED|95.0|-21.04|51.39||Treatment as fixed effect and baseline as covariate.|ANCOVA|||At Week 3||51.39|-21.04|0.3925
72549626|NCT01226797|144629283|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|24.62||||0.208|TWO_SIDED|95.0|-14.85|64.09||Treatment as fixed effect and baseline as covariate.|ANCOVA|||At Week 4||64.09|-14.85|0.2080
72549627|NCT01226797|144629285|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|21.87||||0.0577|TWO_SIDED|95.0|-0.78|44.53||Treatment as fixed effect and baseline as covariate.|ANCOVA|||At Week 1||44.53|-0.78|0.0577
72549628|NCT01226797|144629285|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|9.3||||0.3669|TWO_SIDED|95.0|-11.71|30.3||Treatment as fixed effect and baseline as covariate.|ANCOVA|||At Week 2||30.30|-11.71|0.3669
72549629|NCT01226797|144629285|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|14.09||||0.2482|TWO_SIDED|95.0|-10.62|38.8||Treatment as fixed effect and baseline as covariate.|ANCOVA|||At Week 3||38.80|-10.62|0.2482
72549630|NCT01226797|144629285|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|29.19||||0.0801|TWO_SIDED|95.0|-3.84|62.22||Treatment as fixed effect and baseline as covariate.|ANCOVA|||At Week 4||62.22|-3.84|0.0801
72549631|NCT01226797|144629293|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-22.06||||0.0031|TWO_SIDED|95.0|-35.67|-8.44||Treatment as fixed effect and baseline as covariate.|ANCOVA|||At Week 2||-8.44|-35.67|0.0031
72582812|NCT01839708|144695876|OTHER||||||<|0.05|||||||Mixed Models Analysis|||||||<0.05
72582813|NCT01839708|144695877|OTHER|||||||0.03|||||||Mixed Models Analysis|||||||0.03
72582814|NCT01839708|144695878|OTHER||||||<|0.05|||||||Mixed Models Analysis|||||||<0.05
72582815|NCT01839708|144695879|OTHER||||||<|0.05|||||||Mixed Models Analysis|||||||<0.05
72582816|NCT01839708|144695880|OTHER||||||<|0.05|||||||Mixed Models Analysis|||||||<0.05
72582817|NCT01839708|144695881|OTHER||||||<|0.05|||||||Mixed Models Analysis|||||||<0.05
72582818|NCT01839708|144695882|OTHER||||||<|0.05|||||||Mixed Models Analysis|||||||<0.05
72582819|NCT01839708|144695883|OTHER||||||<|0.05|||||||Mixed Models Analysis|||||||<0.05
72582820|NCT01839708|144695884|OTHER||||||<|0.05|||||||Mixed Models Analysis|||||||<0.05
72412742|NCT01159938|144333513|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.19||||0.155|TWO_SIDED|95.0|-5.25|0.87||P-value is for LS mean difference (high minus low postprandial glucose) in change in PWA at 120-min post-breakfast. Significance was assessed at the 2-sided 5% level.|ANCOVA|LS mean was adjusted for age, BMI, visit, group, condition, group by condition, and random participant.||||0.87|-5.25|0.155
72549632|NCT01226797|144629293|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-16.34||||0.0015|TWO_SIDED|95.0|-25.64|-7.04||Treatment as fixed effect and baseline as covariate.|ANCOVA|||At Week 4||-7.04|-25.64|0.0015
72549633|NCT01988922|144629300|OTHER|Differences between CYP2B6\*1/\*1, CYP2B6\*1/\*6, and CYP2B6\*6/\*6 genotypes for pharmacokinetic parameters were analyzed using one-way ANOVA followed by the Student-Newman-Keuls test for multiple comparisons (Sigmaplot 12.5; Systat Software, Inc, USA). Nonnormal data were log transformed for analysis but reported as the nontransformed results.|||||<|0.05|||||||ANOVA|One-way ANOVA followed by the Student-Newman-Keuls test for multiple comparisons||||||<0.05
72582821|NCT01839708|144695885|OTHER||||||<|0.05|||||||Mixed Models Analysis|||||||<0.05
72582822|NCT01051960|144695898|OTHER|comparison of means|Mean Difference (Final Values)|-93.0||||0.0008|TWO_SIDED|||||significant at p\<0.05|t-test, 2 sided|||Whether change from baseline to 24-weeks is significantly different from zero||||.0008
72582823|NCT01051960|144695899|OTHER||Mean Difference (Final Values)|44.5||||7e-05|TWO_SIDED||||||t-test, 2 sided|||change from baseline to 24 weeks||||0.00007
72582824|NCT01836471|144695921|SUPERIORITY_OR_OTHER||least squares mean|0.01|STANDARD_ERROR_OF_MEAN|0.038||0.7269|TWO_SIDED|90.0|-0.5|0.08|||Mixed Models Analysis|||||0.08|-0.5|0.7269
72582825|NCT01836471|144695922|SUPERIORITY_OR_OTHER||least sqares mean|0.01|STANDARD_ERROR_OF_MEAN|0.05|||TWO_SIDED|90.0|-0.08|0.09||||||||0.09|-0.08|
72582826|NCT01836471|144695922|SUPERIORITY_OR_OTHER||least squares mean|0.04|STANDARD_ERROR_OF_MEAN|0.054|||TWO_SIDED|90.0|-0.04|0.13||||||||0.13|-0.04|
72582827|NCT01836471|144695922|SUPERIORITY_OR_OTHER||least squares mean|-0.04|STANDARD_ERROR_OF_MEAN|0.053|||TWO_SIDED|90.0|-0.13|0.05||||||||0.05|-0.13|
72582828|NCT01836471|144695923|SUPERIORITY_OR_OTHER|||||||0.9179|||||||Mixed Models Analysis|||||||0.9179
72582829|NCT01836471|144695924|SUPERIORITY_OR_OTHER||least squares mean|-0.02|STANDARD_ERROR_OF_MEAN|0.098|||TWO_SIDED|95.0|-0.22|0.17||||||||0.17|-0.22|
72582830|NCT01836471|144695924|SUPERIORITY_OR_OTHER||least sqares mean|-0.07|STANDARD_ERROR_OF_MEAN|0.128|||TWO_SIDED|95.0|-0.32|0.19||||||||0.19|-0.32|
72582831|NCT01836471|144695924|SUPERIORITY_OR_OTHER||least squares mean|0.1|STANDARD_ERROR_OF_MEAN|0.134|||TWO_SIDED|95.0|-0.16|0.37||||||||0.37|-0.16|
72582832|NCT01836471|144695924|SUPERIORITY_OR_OTHER||least squares mean|-0.17|STANDARD_ERROR_OF_MEAN|0.134|||TWO_SIDED|95.0|-0.43|0.09||||||||0.09|-0.43|
72582833|NCT01836471|144695925|SUPERIORITY_OR_OTHER|||||||0.793|||||||Mixed Models Analysis|||||||0.7930
72582834|NCT00776035|144695944|SUPERIORITY||||||<|0.005|||||||Student's t-test|||Average myocardial blood flow, men versus women||||<0.005
72582835|NCT00776035|144695945|SUPERIORITY||||||<|0.05|||||||Student's t-test|||Average myocardial fatty acid utilization, men versus women||||<0.05
72582836|NCT03335475|144695976|SUPERIORITY|||||||0.24|||||||Mixed Models Analysis|||||||0.24
72582837|NCT03335475|144695977|SUPERIORITY|||||||0.7|||||||Mixed Models Analysis|||||||0.70
72582838|NCT03335475|144695978|SUPERIORITY|||||||0.21|||||||Mixed Models Analysis|||||||0.21
72582839|NCT02224157|144696036|NON_INFERIORITY|Non-inferiority analysis based on CI instead of p-value, hence no p-value calculated for this analysis. Upper limit of the 1-sided 95% confidence limit \<1.2 indicates Symbicort 'as needed' is non-inferior to Pulmicort bid|Rate ratio|0.97|||||ONE_SIDED|95.0||1.16|||Negative binomial model|Adjusted for randomised treatment, pre-study treatment and region. Logarithm of follow-up time is used as an offset variable.|A rate ratio less than 1 indicates a lower rate of exacerbations in the Symbicort 'as needed' treatment group.|||1.16||
72582840|NCT02224157|144696037|SUPERIORITY||Hazard Ratio (HR)|0.955||||0.664|TWO_SIDED|95.0|0.777|1.174|||Regression, Cox|Cox regression model with randomised treatment, pre-study treatment and region as covariates.|A hazard ratio less than 1 indicates that Symbicort 'as needed' prolongs the time to first severe exacerbation.|||1.174|0.777|0.664
72549634|NCT04977336|144629301|SUPERIORITY|||||||0.3706|||||||ANCOVA|||||||0.3706
72549635|NCT04977336|144629301|SUPERIORITY|||||||0.5379|||||||ANCOVA|||||||0.5379
72549636|NCT04977336|144629301|SUPERIORITY|||||||0.3859|||||||ANCOVA|||||||0.3859
72549637|NCT04977336|144629301|SUPERIORITY|||||||0.0251|||||||ANCOVA|||||||0.0251
72549638|NCT04977336|144629302|SUPERIORITY|||||||0.2318|||||||ANCOVA|||||||0.2318
72549639|NCT04977336|144629302|SUPERIORITY|||||||0.7615|||||||ANCOVA|||||||0.7615
72549640|NCT04977336|144629302|SUPERIORITY|||||||0.387|||||||ANCOVA|||||||0.3870
72549641|NCT04977336|144629302|SUPERIORITY|||||||0.0823|||||||ANCOVA|||||||0.0823
72549642|NCT04977336|144629303|SUPERIORITY|||||||0.9986|||||||Cochran-Mantel-Haenszel|||||||0.9986
72582841|NCT02224157|144696038|SUPERIORITY||Least Square Mean Difference|-32.6||||0.003|TWO_SIDED|95.0|-53.7|-11.4|||Mixed Models Analysis|Rand treatment,pre-study treatment,region,visit,rand treatment by visit; fixed effects. Patient; random effect, baseline FEV1; covariate.|Mean difference greater than 0 favours Symbicort 'as needed'. Estimate corresponds to average treatment effect across all treatment visits.|||-11.4|-53.7|0.003
72582842|NCT02224157|144696040|SUPERIORITY||Least Square Mean Difference|0.03|||||TWO_SIDED|95.0|0.0|0.07||No p-value was calculated for this efficacy variable|ANCOVA|Model with randomised treatment, pre-study treatment and region as factors, and no. of 'as needed' inhalations at baseline as continuous covariate|A mean difference less than zero indicates a larger mean reduction in number of 'as needed' inhalations in the Symbicort 'as needed' group.|||0.07|0.00|
72412743|NCT01159938|144333513|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.58||||0.685|TWO_SIDED|95.0|-3.46|2.3||P-value is for LS mean difference (high minus low postprandial glucose) in change in PWA at 120-min post-breakfast. Significance was assessed at 2-sided 5% level.|ANCOVA|LS mean was adjusted for age, BMI, visit, group, condition, group by condition, and random participant.||||2.30|-3.46|0.685
72412744|NCT01159938|144333513|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.84||||0.292|TWO_SIDED|95.0|-5.33|1.64||P-value is for LS mean difference (high minus low postprandial glucose) in change in PWA at 180-min post-breakfast. Significance was assessed at the 2-sided 5% level.|ANCOVA|LS mean was adjusted for age, BMI, visit, group, condition, group by condition, and random participant.||||1.64|-5.33|0.292
72549643|NCT04977336|144629303|SUPERIORITY|||||||0.4446|||||||Cochran-Mantel-Haenszel|||||||0.4446
72549644|NCT04977336|144629303|SUPERIORITY|||||||0.5978|||||||Cochran-Mantel-Haenszel|||||||0.5978
72549645|NCT04977336|144629303|SUPERIORITY|||||||0.0479|||||||Cochran-Mantel-Haenszel|||||||0.0479
72549646|NCT04977336|144629304|SUPERIORITY|||||||0.9895|||||||Cochran-Mantel-Haenszel|||||||0.9895
72549647|NCT04977336|144629304|SUPERIORITY|||||||0.2731|||||||Cochran-Mantel-Haenszel|||||||0.2731
72582843|NCT02224157|144696041|SUPERIORITY||Least Square Mean Difference|-6.85|||<|0.001|TWO_SIDED|95.0|-8.37|-5.34|||ANCOVA|adjusted for randomised treatment, pre-study treatment and region as factors and the percent 'as needed' free days during run-in as a cont covariate.|An estimate of difference \>0 means that there was a larger increase in the % of 'as needed' free days in the Symbicort 'as-needed' arm.|||-5.34|-8.37|< 0.001
72582844|NCT02224157|144696042|SUPERIORITY||Least Square Mean Difference|-37.48|||<|0.001|TWO_SIDED|95.0|-39.18|-35.77|||ANOVA|model adjusted for: randomised treatment, pre-study treatment and region.|An estimate of difference \>0 means that there was a higher % of controller use days in the Symbicort 'as-needed' group.|||-35.77|-39.18|<0.001
72582845|NCT02224157|144696043|SUPERIORITY||Least Square Mean Difference|0.109|||<|0.001|TWO_SIDED|95.0|0.068|0.15|||Mixed Models Analysis|rand treatment, pre-study treatment, region, visit, rand treat by visit as fixed, patient as random, and baseline ACQ-5 as covariate.|Mean difference less than 0 favours Symbicort 'as needed'.|||0.150|0.068|<0.001
72582846|NCT02224157|144696044|SUPERIORITY||Least Square Mean Difference|-0.096|||<|0.001|TWO_SIDED|95.0|-0.137|-0.054|||Mixed Models Analysis|rand treatment, pre-study treatment, region, visit, rand treat by visit as fixed, patient as random and baseline AQLQ as covariate.|Mean difference greater than 0 favours Symbicort 'as needed'.|||-0.054|-0.137|<0.001
72412745|NCT01159938|144333513|SUPERIORITY_OR_OTHER||LS Mean Difference|2.04||||0.216|TWO_SIDED|95.0|-1.25|5.33||P-value is for LS mean difference (high minus low postprandial glucose) in change in PWA at 180-min post-breakfast. Significance was assessed at the 2-sided 5% level.|ANCOVA|LS mean was adjusted for age, BMI, visit, group, condition, group by condition, and random participant.||||5.33|-1.25|0.216
72549648|NCT04977336|144629304|SUPERIORITY|||||||0.6492|||||||Cochran-Mantel-Haenszel|||||||0.6492
72549649|NCT04977336|144629304|SUPERIORITY|||||||0.5119|||||||Cochran-Mantel-Haenszel|||||||0.5119
72549650|NCT04977336|144629305|SUPERIORITY|||||||0.3158|||||||Cochran-Mantel-Haenszel|||||||0.3158
72549651|NCT04977336|144629305|SUPERIORITY|||||||0.3247|||||||Cochran-Mantel-Haenszel|||||||0.3247
72549652|NCT04977336|144629305|SUPERIORITY|||||||0.8424|||||||Cochran-Mantel-Haenszel|||||||0.8424
72549653|NCT04977336|144629305|SUPERIORITY|||||||0.2312|||||||Cochran-Mantel-Haenszel|||||||0.2312
72549654|NCT01347710|144629310|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||P-value for sensitivity comparison of flurpiridaz F18 PET MPI vs SPECT MPI for majority rule|McNemar|Two-sided McNemar's (chi-squared) test superiority||||||<0.001
72549655|NCT01347710|144629311|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||p-Value for sensitivity comparison of flurpiridaz F18 PET MPI vs SPECT MPI for majority rule in patients under going pharmacologic stress|McNemar|Two-sided McNemar's (chi-squared) test superiority||||||<0.001
72549656|NCT01347710|144629311|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||p-Value for sensitivity comparison of flurpiridaz F18 PET MPI vs. SPECT MPI for majority rule in females|McNemar|p-Value based on two-sided McNemar's (Chi-squared) test superiority||||||<0.001
72549657|NCT01347710|144629311|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||p-Value for sensitivity comparison of flurpiridaz F18 PET MPI vs SPECT MPI for majority rule in patients with BMI \>/=30|McNemar|p-Value based on two-sided McNemar's (Chi-squared) test superiority||||||<0.001
72549658|NCT01347710|144629312|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Systematic review of literature and meta-analysis of diagnostic efficacy of SPECT MPI to evaluate the performance criteria of SPECT MPI in studies with various levels of control. Analysis of study BMS747158-201. Non-inferiority margin (delta) = 7%||||||0.891|TWO_SIDED|||||p-Value for specificity comparison of flurpiridaz F18 PET MPI vs. SPECT MPI for majority rule in patients undergoing pharmacologic stress|Z test|z test for non inferiority for specificity||||||0.891
72549659|NCT01347710|144629312|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Systematic review of literature and meta-analysis of diagnostic efficacy of SPECT MPI to evaluate the performance criteria of SPECT MPI in studies with various levels of control. Analysis of study BMS747158-201. Non-inferiority margin (delta) = 7%||||||0.546|TWO_SIDED|||||p-Value for specificity comparison of flurpiridaz F18 PET MPI vs. SPECT MPI for majority rule in female patients|z test|z test for non-inferiority for specificity||||||.546
72549660|NCT01347710|144629312|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Systematic review of literature and meta-analysis of diagnostic efficacy of SPECT MPI to evaluate the performance criteria of SPECT MPI in studies with various levels of control. Analysis of study BMS747158-201. Non-inferiority margin (delta) = 7%||||||0.538|TWO_SIDED|||||p-Value for specificity comparison of flurpiridaz F18 PET MPI vs. SPECT MPI for majority rule BMI \>/=30|z test|z test for non-inferiority for specificity||||||.538
72549661|NCT01347710|144629313|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||p-Value for sensitivity comparison of flurpiridaz F18 PET MPI and SPECT MPI for majority rule in the localization of coronary artery disease; LAD|McNemar|Two-sided McNemar (chi-squared) test superiority for sensitivity; LAD||||||<0.001
72549662|NCT01347710|144629313|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||p-Value for sensitivity comparison of flurpiridaz F18 PET MPI and SPECT MPI for majority rule in the localization of coronary artery disease; LCX|McNemar|p-Value based on two-sided McNemar's (Chi-squared) test superiority for sensitivity; LCX||||||<0.001
72412746|NCT01159938|144333513|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.87||||0.065|TWO_SIDED|95.0|-5.92|0.18||P-value is for LS mean difference (high minus low postprandial glucose) in change in PWA at 240-min post-breakfast. Significance was assessed at the 2-sided 5% level.|ANCOVA|LS mean was adjusted for age, BMI, visit, group, condition, group by condition, and random participant.||||0.18|-5.92|0.065
72549663|NCT01347710|144629313|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||p-Value for sensitivity comparison of flurpiridaz F18 PET MPI and SPECT MPI for majority rule in the localization of coronary artery disease; RCA|McNemar|p-Value based on two-sided McNemar's (Chi-squared) test superiority for sensitivity; RCA||||||<0.001
72549664|NCT01347710|144629313|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||p-Value for sensitivity comparison of flurpiridaz F18 PET MPI and SPECT MPI for majority rule in the localization of coronary artery disease; Non-LAD|McNemar|p-Value based on two-sided McNemar's (Chi-squared) test superiority for sensitivity; Non-LAD||||||<0.001
72549665|NCT01347710|144629314|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Systematic review of literature and meta-analysis of diagnostic efficacy of SPECT MPI to evaluate the performance criteria of SPECT MPI in studies with various levels of control. Analysis of study BMS747158-201. Non-inferiority margin (delta) = 7%||||||0.379|TWO_SIDED|||||p-Value for specificity comparison of flurpiridaz F18 PET MPI and SPECT MPI for majority rule in the localization of coronary artery disease; LAD|z Test|z test for non-inferiority for specificity; LAD||||||.379
72549666|NCT01347710|144629314|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Systematic review of literature and meta-analysis of diagnostic efficacy of SPECT MPI to evaluate the performance criteria of SPECT MPI in studies with various levels of control. Analysis of study BMS747158-201. Non-inferiority margin (delta) = 7%||||||0.358|TWO_SIDED|||||p-Value for specificity comparison of flurpiridaz F18 PET MPI and SPECT MPI for majority rule in the localization of coronary artery disease; LCX|Z Test|z test for non-inferiority for specificity; LCX||||||.358
72549667|NCT01347710|144629314|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Systematic review of literature and meta-analysis of diagnostic efficacy of SPECT MPI to evaluate the performance criteria of SPECT MPI in studies with various levels of control. Analysis of study BMS747158-201. Non-inferiority margin (delta) = 7%||||||0.442|TWO_SIDED|||||p-Value for specificity comparison of flurpiridaz F18 PET MPI and SPECT MPI for majority rule in the localization of coronary artery disease; RCA|z Test|z test for non-inferiority for specificity; RCA||||||.442
72549668|NCT01347710|144629314|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Systematic review of literature and meta-analysis of diagnostic efficacy of SPECT MPI to evaluate the performance criteria of SPECT MPI in studies with various levels of control. Analysis of study BMS747158-201. Non-inferiority margin (delta) = 7%||||||0.984|TWO_SIDED|||||p-Value for specificity comparison of flurpiridaz F18 PET MPI and SPECT MPI for majority rule in the localization of coronary artery disease; Non-LAD|z Test|z test for non-inferiority for specificity; non-LAD||||||.984
72549669|NCT01347710|144629315|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||p-Value of sensitivity for flurpiridaz F18 PET MPI vs. SPECT MPI for majority rule; multivessel disease|McNemar|p-Value based on two-sided McNemar's (Chi squared) test superiority||||||<0.001
72549670|NCT01347710|144629316|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Systematic review of literature and meta-analysis of diagnostic efficacy of SPECT MPI to evaluate the performance criteria of SPECT MPI in studies with various levels of control. Analysis of study BMS747158-201. Non-inferiority margin (delta) = 7%||||||0.827|TWO_SIDED|||||p-Value of specificity for comparison of flurpiridaz F18 PET MPI vs. SPECT MPI in detecting multivessel disease|z test|p-Value based on one-sided z test for non-inferiority||||||0.827
72549671|NCT01347710|144629317|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||p-Value for sensitivity comparison of flurpiridaz F18 PET MPI vs SPECT MPI for majority rule; image quality of excellent or good|McNemar|p-Value based on two-sided McNemar's (Chi-squared) test superiority for sensitivity||||||<0.001
72549672|NCT01347710|144629318|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Systematic review of literature and meta-analysis of diagnostic efficacy of SPECT MPI to evaluate the performance criteria of SPECT MPI in studies with various levels of control. Analysis of study protocol number BMS747158-201. Non-inferiority margin (delta) = 7%||||||0.945|ONE_SIDED|||||p-Value for specificity comparison of flurpiridaz F18 PET MPI vs. SPECT MPI|Z Test|one-sided z test for non-inferiority for specificity||||||.945
72549673|NCT01347710|144629319|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Systematic review of literature and meta-analysis of diagnostic efficacy of SPECT MPI to evaluate the performance criteria of SPECT MPI in studies with various levels of control. Analysis of study BMS747158-201. Non-inferiority margin (delta) = 7%||||||0.954|TWO_SIDED|||||p-Value for specificity comparison of flurpiridaz F18 PET MPI vs SPECT MPI for majority rule; image quality excellent/good|z Test|p-Value based on on-sided z test for non-inferiority for specificity||||||0.954
72549674|NCT01347710|144629320|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Log Rank|||||||<0.001
72549675|NCT01347710|144629321|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||McNemar|p-Values are from 2-sided McNemar's test of comparison in proportion of patients with definitely diagnositic certainty between PET and SPECT||||||<0.001
72552729|NCT01032083|144636398|EQUIVALENCE|For the primary outcome, linear regression was used to determine mean difference between treatment groups. Differences between groups are presented as mean differences with associated 95% confidence interval (CI). Baseline values for variables were included as covariates in regression models and adjusted according to analysis of covariance. All analyses were conducted under the intention-to-treat principle.|Mean Difference (Final Values)|2.4||||0.68|TWO_SIDED|95.0|-9.0|14.0|||Regression, Linear|||||14|-9|0.68
72552730|NCT00377260|144636481|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Regression, Logistic|The comparison adjusted for site, history of recurrent acute otitis media and exposure to other children.||Null hypothesis: There is no difference between the two groups regarding the proportion of clinical treatment failures by the on-therapy visit.||||< .001
72412747|NCT01159938|144333513|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.08||||0.954|TWO_SIDED|95.0|-2.96|2.8||P-value is for LS mean difference (high minus low postprandial glucose) in change in PWA at 240-min post-breakfast. Significance was assessed at the 2-sided 5% level.|ANCOVA|LS mean was adjusted for age, BMI, visit, group, condition, group by condition, and random participant.||||2.80|-2.96|0.954
72582847|NCT02224157|144696045|SUPERIORITY||Rate ratio|0.97||||0.754|TWO_SIDED|95.0|0.78|1.2|||Negative binomial model|Adjusted for randomised treatment, pre-study treatment and region. Logarithm of follow-up time is used as an offset variable.|A rate ratio less than 1 indicates a lower rate of exacerbations in the Symbicort 'as needed' treatment group.|||1.20|0.78|0.754
72582848|NCT05906628|144696073|SUPERIORITY||Odds Ratio (OR)|9.82|||<|0.0001|TWO_SIDED|95.0|4.48|21.49|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test was stratified by stratification factors IGA-CHE score (3 or 4) and region (North America or outside of North America).||||21.49|4.48|<0.0001
72582849|NCT05906628|144696073|SUPERIORITY||Response rate difference|42.5|STANDARD_ERROR_OF_MEAN|6.03|||TWO_SIDED|95.0|30.7|54.36||||||||54.36|30.70|
72582850|NCT05906628|144696074|SUPERIORITY||Odds Ratio (OR)|4.23|||<|0.0001|TWO_SIDED|95.0|2.14|8.38|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test was stratified by stratification factors IGA-CHE score (3 or 4) and region (North America or outside of North America).||Week 4||8.38|2.14|<0.0001
72582851|NCT05906628|144696074|SUPERIORITY||Response rate difference|29.5|STANDARD_ERROR_OF_MEAN|6.52|||TWO_SIDED|95.0|16.69|42.24||||||Week 4||42.24|16.69|
72582852|NCT05906628|144696074|SUPERIORITY||Odds Ratio (OR)|3.9|||<|0.0001|TWO_SIDED|95.0|2.02|7.51|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test was stratified by stratification factors IGA-CHE score (3 or 4) and region (North America or outside of North America).||Week 16||7.51|2.02|<0.0001
72582853|NCT05906628|144696074|SUPERIORITY||Response rate difference|29.5|STANDARD_ERROR_OF_MEAN|6.69|||TWO_SIDED|95.0|16.34|42.57||||||Week 16||42.57|16.34|
72582854|NCT05906628|144696075|SUPERIORITY||Odds Ratio (OR)|2.06||||0.1789|TWO_SIDED|95.0|0.718|5.923|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test was stratified by stratification factors IGA-CHE score (3 or 4) and region (North America or outside of North America).||Day 3||5.923|0.718|0.1789
72582855|NCT05906628|144696075|SUPERIORITY||Odds Ratio (OR)|3.79||||0.0024|TWO_SIDED|95.0|1.603|8.951|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test was stratified by stratification factors IGA-CHE score (3 or 4) and region (North America or outside of North America).||Week 1 (Day 7)||8.951|1.603|0.0024
72582856|NCT05906628|144696076|SUPERIORITY||Odds Ratio (OR)|9.91|||<|0.0001|TWO_SIDED|95.0|4.44|22.13|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test was stratified by stratification factors IGA-CHE score (3 or 4) and region (North America or outside of North America).||Week 16||22.13|4.44|<0.0001
72582857|NCT05906628|144696076|SUPERIORITY||Response rate difference|45.6|STANDARD_ERROR_OF_MEAN|6.49|||TWO_SIDED|95.0|32.83|58.27||||||Week 16||58.27|32.83|
72582858|NCT05906628|144696078|SUPERIORITY||Cox regression model|1.719||||0.0025|TWO_SIDED|95.0|1.211|2.44|||Log Rank|stratified by randomization stratification factors|Cox regression model stratified by stratification factors (Baseline IGA-CHE 3/4, Region : North America or outside of North America) was conducted to compare the difference in hazard rate between treatment and vehicle.|||2.440|1.211|0.0025
72582859|NCT05906628|144696081|SUPERIORITY||Cox regression model|1.279||||0.1319|TWO_SIDED|95.0|0.931|1.759|||Log Rank|stratified by randomization stratification factors|Cox regression model stratified by stratification factors (Baseline IGA-CHE 3/4, Region : North America or outside of North America) was conducted to compare the difference in hazard rate between treatment and vehicle.|||1.759|0.931|0.1319
72412748|NCT01159938|144333514|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.02||||0.905|TWO_SIDED|95.0|-0.31|0.27||P-value is for Least Square (LS) mean difference (high minus low postprandial glucose) in change in PAT at 120-min post-breakfast. Significance was assessed at the 2-sided 5% level.|ANCOVA|LS mean was adjusted for age, BMI, visit, group, condition, group by condition, and random participant.||||0.27|-0.31|0.905
72412749|NCT01159938|144333514|SUPERIORITY_OR_OTHER||LS Mean Difference|0.42||||0.004|TWO_SIDED|95.0|0.14|0.69||P-value is for LS mean difference (high minus low postprandial glucose) in change in PAT at 120-min post-breakfast. Significance was assessed at the 2-sided 5% level.|ANCOVA|LS mean was adjusted for age, BMI, visit, group, condition, group by condition, and random participant.||||0.69|0.14|0.004
72582860|NCT00380874|144696110|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.09|STANDARD_ERROR_OF_MEAN|0.08||0.2536||||||Cycle 1. No multiple comparisons adjustment was made.|ANCOVA|Model terms include treatment, study center, and baseline score.|LS means and corresponding standard errors derived from ANCOVA model were used.|Cycle 1. Sample size was based on original primary efficacy parameter (PEP) of time to persistent paresthesia symptoms (symptoms developing in 35% of subjects taking pregabalin and 60% taking placebo symptoms). Assuming Type I error rate of 0.05 and a 2-sided log-rank test for equality of time to persistent symptoms survival curves, the study would have had at least 90% power using 100 subjects per treatment group. The original PEP was modified to secondary due to lack of symptom emergence.||||0.2536
72412750|NCT01159938|144333514|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.09||||0.584|TWO_SIDED|95.0|-0.41|0.23||P-value is for LS mean difference (high minus low postprandial glucose) in change in PAT at 240-min post-breakfast. Significance was assessed at the 2-sided 5% level.|ANCOVA|LS mean was adjusted for age, BMI, visit, group, condition, group by condition, and random participant.||||0.23|-0.41|0.584
72412751|NCT01159938|144333514|SUPERIORITY_OR_OTHER||LS Mean Difference|0.13||||0.436|TWO_SIDED|95.0|-0.19|0.44||P-value is for LS mean difference (high minus low postprandial glucose) in change in PAT at 240-min post-breakfast. Significance was assessed at the 2-sided 5% level.|ANCOVA|LS mean was adjusted for age, BMI, visit, group, condition, group by condition, and random participant.||||0.44|-0.19|0.436
72412752|NCT00086346|144333555|SUPERIORITY_OR_OTHER|||||||0.342|||||||Rank ANCOVA|||||||0.342
72582861|NCT00380874|144696110|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.13|STANDARD_ERROR_OF_MEAN|0.23||0.5757||||||No multiple comparisons adjustment was made.|ANCOVA|Model terms include treatment, study center, and baseline score.|LS means and corresponding standard errors derived from ANCOVA model were used.|Cycle 2. Sample size was based on original primary efficacy parameter (PEP) of time to persistent paresthesia symptoms (symptoms developing in 35% of subjects taking pregabalin and 60% taking placebo symptoms). Assuming Type I error rate of 0.05 and a 2-sided log-rank test for equality of time to persistent symptoms survival curves, the study would have had at least 90% power using 100 subjects per treatment group. The original PEP was modified to secondary due to lack of symptom emergence.||||0.5757
72582862|NCT00380874|144696110|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.15|STANDARD_ERROR_OF_MEAN|0.3||0.6065||||||No multiple comparisons adjustment was made.|ANCOVA|Model terms include treatment, study center, and baseline score.|LS means and corresponding standard errors derived from ANCOVA model were used.|Cycle 3. Sample size was based on original primary efficacy parameter (PEP) of time to persistent paresthesia symptoms (symptoms developing in 35% of subjects taking pregabalin and 60% taking placebo symptoms). Assuming Type I error rate of 0.05 and a 2-sided log-rank test for equality of time to persistent symptoms survival curves, the study would have had at least 90% power using 100 subjects per treatment group. The original PEP was modified to secondary due to lack of symptom emergence.||||0.6065
72582863|NCT00380874|144696110|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.24|STANDARD_ERROR_OF_MEAN|0.31||0.4301||||||No multiple comparisons adjustment was made.|ANCOVA|Model terms include treatment, study center, and baseline score.|LS means and corresponding standard errors derived from ANCOVA model were used.|Cycle 4. Sample size was based on original primary efficacy parameter (PEP) of time to persistent paresthesia symptoms (symptoms developing in 35% of subjects taking pregabalin and 60% taking placebo symptoms). Assuming Type I error rate of 0.05 and a 2-sided log-rank test for equality of time to persistent symptoms survival curves, the study would have had at least 90% power using 100 subjects per treatment group. The original PEP was modified to secondary due to lack of symptom emergence.||||0.4301
72582864|NCT00380874|144696110|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.5|STANDARD_ERROR_OF_MEAN|0.49||0.3125||||||No multiple comparisons adjustment was made.|ANCOVA|Model terms include treatment, study center, and baseline score.|LS means and corresponding standard errors derived from ANCOVA model were used.|Cycle 5. Sample size was based on original primary efficacy parameter (PEP) of time to persistent paresthesia symptoms (symptoms developing in 35% of subjects taking pregabalin and 60% taking placebo symptoms). Assuming Type I error rate of 0.05 and a 2-sided log-rank test for equality of time to persistent symptoms survival curves, the study would have had at least 90% power using 100 subjects per treatment group. The original PEP was modified to secondary due to lack of symptom emergence.||||0.3125
72582865|NCT00380874|144696110|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.09|STANDARD_ERROR_OF_MEAN|0.41||0.8169||||||No multiple comparisons adjustment was made.|ANCOVA|Model terms include treatment, study center, and baseline score.|LS means and corresponding standard errors derived from ANCOVA model were used.|Cycle 6.Sample size was based on original primary efficacy parameter (PEP) of time to persistent paresthesia symptoms (symptoms developing in 35% of subjects taking pregabalin and 60% taking placebo symptoms). Assuming Type I error rate of 0.05 and a 2-sided log-rank test for equality of time to persistent symptoms survival curves, the study would have had at least 90% power using 100 subjects per treatment group. The original PEP was modified to secondary due to lack of symptom emergence.||||0.8169
72582866|NCT00380874|144696110|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.03|STANDARD_ERROR_OF_MEAN|0.4||0.9359|||||||ANCOVA|Model terms include treatment, study center, and baseline score.|LS means and corresponding standard errors derived from ANCOVA model were used.|Cycle 7. Sample size was based on original primary efficacy parameter (PEP) of time to persistent paresthesia symptoms (symptoms developing in 35% of subjects taking pregabalin and 60% taking placebo symptoms). Assuming Type I error rate of 0.05 and a 2-sided log-rank test for equality of time to persistent symptoms survival curves, the study would have had at least 90% power using 100 subjects per treatment group. The original PEP was modified to secondary due to lack of symptom emergence.||||0.9359
72582867|NCT00380874|144696110|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.4||0.6233|||||||ANCOVA|Model terms include treatment, study center, and baseline score.|LS means and corresponding standard errors derived from ANCOVA model were used.|Cycle 8. Sample size was based on original primary efficacy parameter (PEP) of time to persistent paresthesia symptoms (symptoms developing in 35% of subjects taking pregabalin and 60% taking placebo symptoms). Assuming Type I error rate of 0.05 and a 2-sided log-rank test for equality of time to persistent symptoms survival curves, the study would have had at least 90% power using 100 subjects per treatment group. The original PEP was modified to secondary due to lack of symptom emergence.||||0.6233
72582868|NCT00380874|144696110|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.73|STANDARD_ERROR_OF_MEAN|0.5||0.1569||||||No multiple comparisons adjustment was made.|ANCOVA|Model terms include treatment, study center, and baseline score.|LS means and corresponding standard errors derived from ANCOVA model were used.|Cycle 9.Sample size was based on original primary efficacy parameter (PEP) of time to persistent paresthesia symptoms (symptoms developing in 35% of subjects taking pregabalin and 60% taking placebo symptoms). Assuming Type I error rate of 0.05 and a 2-sided log-rank test for equality of time to persistent symptoms survival curves, the study would have had at least 90% power using 100 subjects per treatment group. The original PEP was modified to secondary due to lack of symptom emergence.||||0.1569
72582869|NCT00380874|144696111|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.04|STANDARD_ERROR_OF_MEAN|0.11||0.7207||95.0|-0.25|0.17||Model terms include treatment, study center, and baseline score.|ANCOVA|Cycle 1. No multiple comparisons adjustment was made.|LS means and corresponding standard errors derived from ANCOVA model were used.|Cycle 1.||0.17|-0.25|0.7207
72582870|NCT00380874|144696111|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.37|STANDARD_ERROR_OF_MEAN|0.36||0.3111||95.0|-0.36|1.1||No multiple comparisons adjustment was made.|ANCOVA|Model terms include treatment, study center, and baseline score.|LS means and corresponding standard errors derived from ANCOVA model were used.|Cycle 2.||1.10|-0.36|0.3111
72582871|NCT00380874|144696111|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.26|STANDARD_ERROR_OF_MEAN|0.48||0.5925||95.0|-0.7|1.22||No multiple comparisons adjustment was made.|ANCOVA|Model terms include treatment, study center, and baseline score.|LS means and corresponding standard errors derived from ANCOVA model were used.|Cycle 3.||1.22|-0.70|0.5925
72582872|NCT00380874|144696111|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.3|STANDARD_ERROR_OF_MEAN|0.55||0.5812||95.0|-0.8|1.41||No multiple comparisons adjustment was made.|ANCOVA|Model terms include treatment, study center, and baseline score.|LS means and corresponding standard errors derived from ANCOVA model were used.|Cycle 4.||1.41|-0.80|0.5812
72582873|NCT00380874|144696111|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.75|STANDARD_ERROR_OF_MEAN|0.7||0.2925||95.0|-0.67|2.16||No multiple comparisons adjustment was made.|ANCOVA|Model terms include treatment, study center, and baseline score.|LS means and corresponding standard errors derived from ANCOVA model were used.|Cycle 5.||2.16|-0.67|0.2925
72582874|NCT00380874|144696111|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.54||0.9276||95.0|-1.15|1.05||No multiple comparisons adjustment was made.|ANCOVA|Model terms include treatment, study center, and baseline score.|LS means and corresponding standard errors derived from ANCOVA model were used.|Cycle 6.||1.05|-1.15|0.9276
72582875|NCT00380874|144696111|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.53||0.9952||95.0|-1.06|1.07|||ANCOVA|Model terms include treatment, study center, and baseline score.||Cycle 7.||1.07|-1.06|0.9952
72582876|NCT00380874|144696111|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.27|STANDARD_ERROR_OF_MEAN|0.55||0.6265||95.0|-0.85|1.38|||ANCOVA|Model terms include treatment, study center, and baseline score.|LS means and corresponding standard errors derived from ANCOVA model were used.|Cycle 8.||1.38|-0.85|0.6265
72582877|NCT00380874|144696111|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.51|STANDARD_ERROR_OF_MEAN|0.62||0.4209||95.0|-1.77|0.76||No multiple comparisons adjustment was made.|ANCOVA|Model terms include treatment, study center, and baseline score.|LS means and corresponding standard errors derived from ANCOVA model were used.|Cycle 9.||0.76|-1.77|0.4209
72582878|NCT00380874|144696111|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.54||0.9657||95.0|-1.06|1.11||No multiple comparisons adjustment was made.|ANCOVA|Model terms include treatment, study center, and baseline score.|LS means and corresponding standard errors derived from ANCOVA model were used.|Last Observation Carried Forward (LOCF)endpoint.||1.11|-1.06|0.9657
72582879|NCT00380874|144696112|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.06|STANDARD_ERROR_OF_MEAN|0.09||0.5392||95.0|-0.24|0.12|||ANCOVA|||Cycle 1.||0.12|-0.24|0.5392
72582880|NCT00380874|144696112|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.13|STANDARD_ERROR_OF_MEAN|0.22||0.5412||95.0|-0.3|0.57|||ANCOVA|||Cycle 2.||0.57|-0.30|0.5412
72412753|NCT00086346|144333556|SUPERIORITY_OR_OTHER|||||||0.017|||||||Cochran-Mantel-Haenszel|||Comparison between treatment groups of percentages of patients with biopsy-confirmed acute rejection.||||0.017
72549676|NCT01606306|144629334|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|95.0||||Rank-ordered logistic regression (ROLR) was used to model the probability of best response for each treatment and bootstrapping was used to calculate confidence intervals.|rank-order logistic regression|ROLR is in the class of Discrete Choice models, which seek to estimate the probability that an individual responds best to a specific treatments.||The primary analysis tested the null hypothesis of all three treatments having equal probability to yield the best response as defined by the criteria defining the primary outcome. A sample size of 300 participants was selected to test the primary null hypothesis of all three treatments having equal probability (one-third) to yield the best response with statistical power of at least 0.90 if any one of the three treatments actually has probability of at least one-half to yield the best response.|The probabilistic construct of the Discrete Choice (DC) model does not reflect individual behavior that is intrinsically probabilistic, but rather population heterogeneity. DC models rely on stochastic assumptions to account for unobserved factors related to the treatments themselves and to characteristics of study participants. Specifically, that each treatment has an underlying utility that may differ from one individual to another. Mathematically, these utilities are represented by U\_t, where t denotes the treatment. Utility can be thought of as a latent variable quantifying treatment response where higher values indicate better response. The U\_t can be used to find the probability (P) of best response for each treatment by the following equation: P\_t = exp(U\_t) / \[exp(U\_A) + exp(U\_B) + exp(U\_C)\], where A, B, and C, denote the three study treatments. The primary analysis tested whether the three treatments have equal utility and, thus, equal probability of best response.|||<0.0001
72549677|NCT00970281|144629340|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The p-value was based on an analysis of variance (ANOVA) model that included treatment and site as a factor.|ANOVA|||Sample size of at least 45 participants per group was necessary to verify decreases in PANSS-EC total score were significantly greater in olanzapine group than placebo group using a t-test with a power of 90% and a 2-sided significance level of 5%.||||<0.001
72549678|NCT00970281|144629341|SUPERIORITY_OR_OTHER|||||||0.009||95.0||||This is the p-value for 0.25 hour after first IM injection.|ANOVA|||||||0.009
72549679|NCT00970281|144629341|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||This is the p-value for the 0.50 hour after first IM injection.|ANOVA|||||||<0.001
72549680|NCT00970281|144629341|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||This is the p-value for the 1 hour after first IM injection.|ANOVA|||||||<0.001
72549681|NCT00970281|144629341|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||This is the p-value for the 1.5 hour after first IM injection.|ANOVA|||||||<0.001
72549682|NCT00970281|144629342|SUPERIORITY_OR_OTHER|||||||0.008||95.0|||||ANOVA|||||||0.008
72549683|NCT00970281|144629343|SUPERIORITY_OR_OTHER|||||||0.008||95.0|||||Fisher Exact|||||||0.008
72549684|NCT00970281|144629344|SUPERIORITY_OR_OTHER|||||||0.167||95.0||||This is the p-value for the 0.5 hour after the first IM injection.|Fisher Exact|||||||0.167
72582881|NCT00380874|144696112|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.21|STANDARD_ERROR_OF_MEAN|0.34||0.5358||95.0|-0.48|0.9|||ANCOVA|||Cycle 3.||0.90|-0.48|0.5358
72582882|NCT00380874|144696112|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.34|STANDARD_ERROR_OF_MEAN|0.41||0.4059||95.0|-0.48|1.17|||ANCOVA|||Cycle 4.||1.17|-0.48|0.4059
72549685|NCT00970281|144629344|SUPERIORITY_OR_OTHER|||||||0.134||95.0||||This is the p-value for the 1 hour after the first IM injection.|Fisher Exact|||||||0.134
72549686|NCT00970281|144629344|SUPERIORITY_OR_OTHER|||||||0.008||95.0||||This is the p-value for the 1.5 hour after the first IM injection.|Fisher Exact|||||||0.008
72549687|NCT00970281|144629344|SUPERIORITY_OR_OTHER|||||||0.008||95.0||||This is the p-value for the 2 hours after the first IM injection.|Fisher Exact|||||||0.008
72549688|NCT00970281|144629344|SUPERIORITY_OR_OTHER|||||||0.204||95.0||||This is the p-value for the 24 hours after the first IM injection.|Fisher Exact|||||||0.204
72549689|NCT00970281|144629345|SUPERIORITY_OR_OTHER|||||||1||95.0||||This is the p-value for Parkinsonism.|Fisher Exact|||||||1.000
72549690|NCT02003183|144629346|SUPERIORITY||Mean Difference (Final Values)|0.09|STANDARD_DEVIATION|0.1|<|0.02|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||This analysis applies to the Amygdala.||||<0.02
72549691|NCT02480764|144629401|NON_INFERIORITY|A test for noninferiority was done using a margin of 1.5 mm Hg. A test for significant difference was performed at 5% level.|Least Square Mean Difference|-1.932|STANDARD_ERROR_OF_MEAN|1.4512||0.184|TWO_SIDED|95.0|-4.782|0.918||Change at Week 8: P-value was calculated using analysis of covariance (ANCOVA) model, with treatment group as a fixed effect and baseline trough sitting clinic SBP as a continuous covariate.|ANCOVA|||||0.918|-4.782|0.184
72549692|NCT02480764|144629401|NON_INFERIORITY|A test for noninferiority was done using a margin of 1.5 mm Hg. A test for significant difference was performed at 5% level.|Least Square Mean Difference|-3.685|STANDARD_ERROR_OF_MEAN|1.4344||0.01|TWO_SIDED|95.0|-6.502|-0.868||Change at Week 8: P-value was calculated using ANCOVA model, with treatment group as a fixed effect and baseline trough sitting clinic SBP as a continuous covariate.|ANCOVA|||||-0.868|-6.502|0.010
72549693|NCT02480764|144629402|OTHER||Least Square Mean Difference|-1.459|STANDARD_ERROR_OF_MEAN|0.9455||0.123|TWO_SIDED|95.0|-3.316|0.397||Change at Week 8: P-value was calculated using ANCOVA model, with treatment group as a fixed effect and baseline trough sitting clinic DBP as a continuous covariate.|ANCOVA|||||0.397|-3.316|0.123
72549694|NCT02480764|144629402|OTHER||Least Square Mean Difference|-2.822|STANDARD_ERROR_OF_MEAN|0.9354||0.003|TWO_SIDED|95.0|-4.659|-0.985||Change at 8 Week: P-value was calculated using ANCOVA model, with treatment group as a fixed effect and baseline trough sitting clinic DBP as a continuous covariate.|ANCOVA|||||-0.985|-4.659|0.003
72582883|NCT00380874|144696112|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.54|STANDARD_ERROR_OF_MEAN|0.49||0.2712||95.0|-0.44|1.52|||ANCOVA|||Cycle 5.||1.52|-0.44|0.2712
72412754|NCT00086346|144333557|SUPERIORITY_OR_OTHER||||||>|0.05|||||||1 way ANOVA, two sided|||||||>0.05
72582884|NCT00380874|144696112|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.04|STANDARD_ERROR_OF_MEAN|0.38||0.9181||95.0|-0.81|0.73|||ANCOVA|||Cycle 6.||0.73|-0.81|0.9181
72549695|NCT02480764|144629403|OTHER||Odds Ratio (OR)|0.877|STANDARD_ERROR_OF_MEAN|0.192||0.548|TWO_SIDED|95.0|0.571|1.347||P-value was calculated using logistic regression model with treatment group as a fixed effect and baseline trough SBP as a continuous covariate.|Regression, Logistic|||||1.347|0.571|0.548
72549696|NCT02480764|144629403|OTHER||Odds Ratio (OR)|0.979|STANDARD_ERROR_OF_MEAN|0.2136||0.921|TWO_SIDED|95.0|0.638|1.501||P-value was calculated using logistic regression model with treatment group as a fixed effect and baseline trough SBP as a continuous covariate.|Regression, Logistic|||||1.501|0.638|0.921
72549697|NCT02480764|144629404|OTHER||Odds Ratio (OR)|1.033|STANDARD_ERROR_OF_MEAN|0.2805||0.904|TWO_SIDED|95.0|0.607|1.759||P-value was calculated using logistic regression model with treatment group as a fixed effect and baseline trough DBP as a continuous covariate.|Regression, Logistic|||||1.759|0.607|0.904
72549698|NCT02480764|144629404|OTHER||Odds Ratio (OR)|1.074|STANDARD_ERROR_OF_MEAN|0.2897||0.79|TWO_SIDED|95.0|0.633|1.823||P-value was calculated using logistic regression model with treatment group as a fixed effect and baseline trough DBP as a continuous covariate.|Regression, Logistic|||||1.823|0.633|0.790
72549699|NCT02480764|144629405|OTHER||Odds Ratio (OR)|0.901|STANDARD_ERROR_OF_MEAN|0.1916||0.624|TWO_SIDED|95.0|0.594|1.367||P-value was calculated using logistic regression model with treatment group as a fixed effect and baseline trough SBP as a continuous covariate.|Regression, Logistic|||||1.367|0.594|0.624
72549700|NCT02480764|144629405|OTHER||Odds Ratio (OR)|1.103|STANDARD_ERROR_OF_MEAN|0.235||0.647|TWO_SIDED|95.0|0.726|1.674||P-value was calculated using logistic regression model with treatment group as a fixed effect and baseline trough SBP as a continuous covariate.|Regression, Logistic|||||1.674|0.726|0.647
72549701|NCT02480764|144629406|OTHER||Odds Ratio (OR)|0.831|STANDARD_ERROR_OF_MEAN|0.1846||0.404|TWO_SIDED|95.0|0.537|1.284||Clinic SBP \<140 mm Hg: P-value was calculated using logistic regression model with treatment group as a fixed effect and baseline trough SBP as a continuous covariate.|Regression, Logistic|||||1.284|0.537|0.404
72549702|NCT02480764|144629406|OTHER||Odds Ratio (OR)|0.937|STANDARD_ERROR_OF_MEAN|0.2078||0.768|TWO_SIDED|95.0|0.606|1.447||Clinic SBP \<140 mm Hg: P-value was calculated using logistic regression model with treatment group as a fixed effect and baseline trough SBP as a continuous covariate.|Regression, Logistic|||||1.447|0.606|0.768
72549703|NCT02480764|144629406|OTHER||Odds Ratio (OR)|1.051|STANDARD_ERROR_OF_MEAN|0.2837||0.852|TWO_SIDED|95.0|0.62|1.784||Clinic DBP \<90 mm Hg: P-value was calculated using logistic regression model with treatment group as a fixed effect and baseline trough DBP as a continuous covariate.|Regression, Logistic|||||1.784|0.620|0.852
72549704|NCT02480764|144629406|OTHER||Odds Ratio (OR)|1.045|STANDARD_ERROR_OF_MEAN|0.2788||0.868|TWO_SIDED|95.0|0.62|1.763||Clinic DBP \<90 mm Hg: P-value was calculated using logistic regression model with treatment group as a fixed effect and baseline trough DBP as a continuous covariate.|Regression, Logistic|||||1.763|0.620|0.868
72582885|NCT00380874|144696112|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.33|STANDARD_ERROR_OF_MEAN|0.42||0.4357||95.0|-0.52|1.17|||ANCOVA|||Cycle 7.||1.17|-0.52|0.4357
72582886|NCT00380874|144696112|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.33|STANDARD_ERROR_OF_MEAN|0.49||0.5103||95.0|-0.67|1.33|||ANCOVA|||||1.33|-0.67|0.5103
72549705|NCT02480764|144629406|OTHER||Odds Ratio (OR)|1.042|STANDARD_ERROR_OF_MEAN|0.2244||0.847|TWO_SIDED|95.0|0.684|1.59||Clinic SBP\<140 mm Hg and DBP\<90 mm Hg: P-value was calculated using logistic regression model with treatment group as a fixed effect and baseline trough SBP as a continuous covariate.|Regression, Logistic|||||1.590|0.684|0.847
72549706|NCT02480764|144629406|OTHER||Odds Ratio (OR)|1.172|STANDARD_ERROR_OF_MEAN|0.2517||0.46|TWO_SIDED|95.0|0.769|1.785||Clinic SBP\<140 mm Hg and DBP\<90 mm Hg: P-value was calculated using logistic regression model with treatment group as a fixed effect and baseline trough SBP as a continuous covariate.|Regression, Logistic|||||1.785|0.769|0.460
72549707|NCT02480764|144629407|OTHER||Odds Ratio (OR)|1.487|STANDARD_ERROR_OF_MEAN|0.3333||0.077|TWO_SIDED|95.0|0.958|2.307||Clinic SBP\<130 mm Hg: P-value was calculated using logistic regression model with treatment group as a fixed effect and baseline trough SBP as a continuous covariate.|Regression, Logistic|||||2.307|0.958|0.077
72549708|NCT02480764|144629407|OTHER||Odds Ratio (OR)|1.914|STANDARD_ERROR_OF_MEAN|0.4229||0.003|TWO_SIDED|95.0|1.241|2.951||Clinic SBP\<130 mm Hg: P-value was calculated using logistic regression model with treatment group as a fixed effect and baseline trough SBP as a continuous covariate.|Regression, Logistic|||||2.951|1.241|0.003
72549709|NCT02480764|144629407|OTHER||Odds Ratio (OR)|1.427|STANDARD_ERROR_OF_MEAN|0.3414||0.137|TWO_SIDED|95.0|0.893|2.28||Clinic DBP\<80 mm Hg: P-value was calculated using logistic regression model with treatment group as a fixed effect and baseline trough DBP as a continuous covariate.|Regression, Logistic|||||2.280|0.893|0.137
72549710|NCT02480764|144629407|OTHER||Odds Ratio (OR)|2.017|STANDARD_ERROR_OF_MEAN|0.4816||0.003|TWO_SIDED|95.0|1.263|3.22||Clinic DBP \<80 mm Hg: P-value was calculated using logistic regression model with treatment group as a fixed effect and baseline trough DBP as a continuous covariate.|Regression, Logistic|||||3.220|1.263|0.003
72549711|NCT02480764|144629407|OTHER||Odds Ratio (OR)|1.424|STANDARD_ERROR_OF_MEAN|0.3407||0.14|TWO_SIDED|95.0|0.891|2.276||Clinic SBP\<130 mm Hg and DBP\<80 mm Hg: P-value was calculated using logistic regression model with treatment group as a fixed effect and baseline trough SBP as a continuous covariate.|Regression, Logistic|||||2.276|0.891|0.140
72549712|NCT02480764|144629407|OTHER||Odds Ratio (OR)|1.769|STANDARD_ERROR_OF_MEAN|0.4136||0.015|TWO_SIDED|95.0|1.118|2.797||Clinic SBP\<130 mm Hg and DBP\<80 mm Hg: P-value was calculated using logistic regression model with treatment group as a fixed effect and baseline trough SBP as a continuous covariate.|Regression, Logistic|||||2.797|1.118|0.015
72549713|NCT03629249|144629408|SUPERIORITY|||||||0.714|||||||Wilcoxon (Mann-Whitney)|||||||0.714
72549714|NCT03629249|144629408|SUPERIORITY|||||||0.734|||||||Wilcoxon (Mann-Whitney)|||||||0.734
72582887|NCT00380874|144696112|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.11|STANDARD_ERROR_OF_MEAN|0.58||0.8499||95.0|-1.29|1.07|||ANCOVA|||Cycle 9.||1.07|-1.29|0.8499
72549715|NCT03629249|144629409|SUPERIORITY|||||||0.665|||||||Wilcoxon (Mann-Whitney)|||||||0.665
72549716|NCT03629249|144629409|SUPERIORITY|||||||0.91|||||||Wilcoxon (Mann-Whitney)|||||||0.910
72582888|NCT00380874|144696112|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.13|STANDARD_ERROR_OF_MEAN|0.39||0.7359||95.0|-0.9|0.64|||ANCOVA|||LOCF endpoint.||0.64|-0.90|0.7359
72582889|NCT00380874|144696113|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.11|STANDARD_ERROR_OF_MEAN|0.09||0.2034||95.0|-0.06|0.29|||ANCOVA|||Burning Spontaneous Pain Cycle 3||0.29|-0.06|0.2034
72412755|NCT00086346|144333558|NON_INFERIORITY_OR_EQUIVALENCE|The a priori criterion for declaring non-inferiority was a lower bound of the 95% confidence interval (CI) having a ≥ 5% difference in graft loss. -5.2 is \< 5 % difference.|Mean Difference (Net)|-1.2||||||95.0|-5.2|2.8|||||Weighted difference in percentage of graft loss: (CNI% minus SRL%); negative values are favorable to CNI group|||2.8|-5.2|
72549717|NCT01030965|144629420|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.159|||<|0.001|TWO_SIDED|95.0|0.088|0.229|||Repeated Measures Analysis of Covariance|||||0.229|0.088|<0.001
72549718|NCT01030965|144629420|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.168|||<|0.001|TWO_SIDED|95.0|0.099|0.238|||Repeated Measures Analysis of Covariance|||||0.238|0.099|<0.001
72549719|NCT01030965|144629420|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.15|||<|0.001|TWO_SIDED|95.0|0.08|0.22|||Repeated Measures Analysis of Covariance|||||0.220|0.080|<0.001
72549720|NCT00743197|144629463|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|0|Other|0.0|STANDARD_DEVIATION|0.0||||||||0||||0||||
72549721|NCT02130466|144629479|OTHER||Hazard Ratio (HR)|0.46|||||TWO_SIDED|95.0|0.29|0.74|||||Cox regression model|||0.74|0.29|
72549722|NCT02130466|144629486|OTHER||Hazard Ratio (HR)|0.6|||||TWO_SIDED|95.0|0.38|0.95|||||Cox regression model|||0.95|0.38|
72549723|NCT04529109|144629547|SUPERIORITY|The superiority of the Test lens was concluded if the lower limit of the 95% credible interval was above 0.90.|Mean Proportion|0.9998|STANDARD_DEVIATION|0.0005|||TWO_SIDED|95.0|0.999|1.0|||Bayesian Binary model||Interval presented is a 95% Credible interval.|||1.000|0.999|
72549724|NCT02405195|144629553|OTHER|||||||0.638||||||Bonferroni-Holm adjustment for multiple comparisons was used|ANOVA|||Repeated measures ANOVA throughout measurement period (before, during and after CPB).||||0.638
72549725|NCT02405195|144629554|OTHER|||||||0.972||||||Bonferroni-Holm adjustment for multiple comparisons was used|ANOVA|||Repeated measures ANOVA||||0.972
72549726|NCT02405195|144629555|OTHER||||||<|0.001||||||Bonferroni-Holm adjustment for multiple comparisons was used|ANOVA|||Repeated measures ANOVA||||<0.001
72549727|NCT01691248|144629570|SUPERIORITY_OR_OTHER||Percentage Difference|2.2||||0.2778|TWO_SIDED|95.0|-5.1|9.5||1-sided Wald test for a difference in proportions using an unpooled estimate of variance.|One-sided Wald p-value||Placebo minus Fidaxomicin|||9.5|-5.1|0.2778
72549728|NCT01691248|144629571|SUPERIORITY_OR_OTHER||Percentage difference|0.6||||0.442|TWO_SIDED|95.0|-7.1|8.2||1-sided Wald test for a difference in proportions using an unpooled estimate of variance.|One-sided Wald p-value||Placebo minus Fidaxomicin|||8.2|-7.1|0.4420
72549729|NCT01691248|144629572|SUPERIORITY_OR_OTHER||Percentage difference|1.9||||0.3091|TWO_SIDED|95.0|-5.5|9.2||1-sided Wald test for a difference in proportions using an unpooled estimate of variance.|One-sided Wald p-value||Placebo minus Fidaxomicin|||9.2|-5.5|0.3091
72549730|NCT02863575|144629573|SUPERIORITY||Least square (LS) means difference|2.68||||0.306|TWO_SIDED|95.0|-2.46|7.82|||ANCOVA|||||7.82|-2.46|0.306
72549731|NCT02863575|144629574|SUPERIORITY||LS mean difference|1.09||||0.056|TWO_SIDED|95.0|-0.03|2.2|||ANCOVA|||SPRID 0-2||2.20|-0.03|0.056
72549732|NCT02863575|144629574|SUPERIORITY||LS means difference|11.13|||<|0.001|TWO_SIDED|95.0|9.54|12.73|||ANCOVA|||SPRID 0-2||12.73|9.54|< 0.001
72549733|NCT02863575|144629574|SUPERIORITY||LS mean difference|10.05|||<|0.001|TWO_SIDED|95.0|8.45|11.64|||ANCOVA|||SPRID 0-2||11.64|8.45|< 0.001
72549734|NCT02863575|144629574|SUPERIORITY||LS mean difference|1.58||||0.177|TWO_SIDED|95.0|-0.72|3.87|||ANCOVA|||SPRID 0-4||3.87|-0.72|0.177
72549735|NCT02863575|144629574|SUPERIORITY||LS mean difference|24.04|||<|0.001|TWO_SIDED|95.0|20.76|27.32|||ANCOVA|||SPRID 0-4||27.32|20.76|< 0.001
72549736|NCT02863575|144629574|SUPERIORITY||LS mean difference|22.46|||<|0.001|TWO_SIDED|95.0|19.18|25.75|||ANCOVA|||SPRID 0-4||25.75|19.18|< 0.001
72549737|NCT02863575|144629574|SUPERIORITY||LS mean difference|2.39||||0.201|TWO_SIDED|95.0|-1.28|6.06|||ANCOVA|||SPRID 0-6||6.06|-1.28|0.201
72549738|NCT02863575|144629574|SUPERIORITY||LS mean difference|34.3|||<|0.001|TWO_SIDED|95.0|29.06|39.55|||ANCOVA|||SPRID 0-6||39.55|29.06|< 0.001
72549739|NCT02863575|144629574|SUPERIORITY||LS mean difference|31.91|||<|0.001|TWO_SIDED|95.0|26.67|37.16|||ANCOVA|||SPRID 0-6||37.16|26.67|< 0.001
72549740|NCT02863575|144629574|SUPERIORITY||LS mean difference|40.85|||<|0.001|TWO_SIDED|95.0|33.49|48.2|||ANCOVA|||SPRID 0-8||48.20|33.49|< 0.001
72549741|NCT02863575|144629574|SUPERIORITY||LS mean difference|38.17|||<|0.001|TWO_SIDED|95.0|30.81|45.52|||ANCOVA|||SPRID 0-8||45.52|30.81|< 0.001
72549742|NCT02863575|144629575|SUPERIORITY||LS means difference|0.73||||0.066|TWO_SIDED|95.0|-0.05|1.5|||ANCOVA|||SPID 0-2||1.50|-0.05|0.066
72549743|NCT02863575|144629575|SUPERIORITY||LS means difference|7.55|||<|0.001|TWO_SIDED|95.0|6.44|8.66|||ANCOVA|||SPID 0-2||8.66|6.44|< 0.001
72549744|NCT02863575|144629575|SUPERIORITY||LS means difference|6.82|||<|0.001|TWO_SIDED|95.0|5.71|7.93|||ANCOVA|||SPID 0-2||7.93|5.71|< 0.001
72549745|NCT02863575|144629575|SUPERIORITY||LS means difference|1.14||||0.165|TWO_SIDED|95.0|-0.47|2.74|||ANCOVA|||SPID 0-4||2.74|-0.47|0.165
72549746|NCT02863575|144629575|SUPERIORITY||LS means difference|16.35|||<|0.001|TWO_SIDED|95.0|14.05|18.64|||ANCOVA|||SPID 0-4||18.64|14.05|< 0.001
72549747|NCT02863575|144629575|SUPERIORITY||LS means difference|15.21|||<|0.001|TWO_SIDED|95.0|12.91|17.51|||ANCOVA|||SPID 0-4||17.51|12.91|< 0.001
72549748|NCT02863575|144629575|SUPERIORITY||LS means difference|1.78||||0.172|TWO_SIDED|95.0|-0.78|4.34|||ANCOVA|||SPID 0-6||4.34|-0.78|0.172
72549749|NCT02863575|144629575|SUPERIORITY||LS means difference|23.37|||<|0.001|TWO_SIDED|95.0|19.71|27.03|||ANCOVA|||SPID 0-6||27.03|19.71|< 0.001
72549750|NCT02863575|144629575|SUPERIORITY||LS means difference|21.59|||<|0.001|TWO_SIDED|95.0|17.93|25.25|||ANCOVA|||SPID 0-6||25.25|17.93|< 0.001
72549751|NCT02863575|144629575|SUPERIORITY||LS means difference|2.1||||0.249|TWO_SIDED|95.0|-1.47|5.67|||ANCOVA|||SPID 0-8||5.67|-1.47|0.249
72549752|NCT02863575|144629575|SUPERIORITY||LS means difference|27.88|||<|0.001|TWO_SIDED|95.0|22.78|32.99|||ANCOVA|||SPID 0-8||32.99|22.78|< 0.001
72549753|NCT02863575|144629575|SUPERIORITY||LS means difference|25.79|||<|0.001|TWO_SIDED|95.0|20.68|30.89|||ANCOVA|||SPID 0-8||30.89|20.68|< 0.001
72549754|NCT02863575|144629576|SUPERIORITY||LS means difference|0.36||||0.044|TWO_SIDED|95.0|0.01|0.71|||ANCOVA|||TOTPAR 0-2||0.71|0.01|0.044
72549755|NCT02863575|144629576|SUPERIORITY||LS means difference|3.59|||<|0.001|TWO_SIDED|95.0|3.09|4.09|||ANCOVA|||TOTPAR 0-2||4.09|3.09|< 0.001
72549756|NCT02863575|144629576|SUPERIORITY||LS means difference|3.23|||<|0.001|TWO_SIDED|95.0|2.73|3.73|||ANCOVA|||TOTPAR 0-2||3.73|2.73|< 0.001
72549757|NCT02863575|144629576|SUPERIORITY||LS means difference|0.44||||0.224|TWO_SIDED|95.0|-0.27|1.15|||ANCOVA|||TOTPAR 0-4||1.15|-0.27|0.224
72549758|NCT02863575|144629576|SUPERIORITY||LS means difference|7.69|||<|0.001|TWO_SIDED|95.0|6.68|8.71|||ANCOVA|||TOTPAR 0-4||8.71|6.68|< 0.001
72549759|NCT02863575|144629576|SUPERIORITY||LS means difference|7.25|||<|0.001|TWO_SIDED|95.0|6.23|8.27|||ANCOVA|||TOTPAR 0-4||8.27|6.23|< 0.001
72582890|NCT00380874|144696113|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.14|STANDARD_ERROR_OF_MEAN|0.13||0.3062||95.0|-0.4|0.13|||ANCOVA|||Burning Spontaneous Pain Cycle 4||0.13|-0.40|0.3062
72582891|NCT00380874|144696113|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.13|STANDARD_ERROR_OF_MEAN|0.12||0.2787||95.0|-0.37|0.11|||ANCOVA|||Burning Spontaneous Pain Cycle 5||0.11|-0.37|0.2787
72582892|NCT00380874|144696113|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.14|STANDARD_ERROR_OF_MEAN|0.17||0.4124||95.0|-0.2|0.47|||ANCOVA|||Burning Spontaneous Pain Cycle 6||0.47|-0.20|0.4124
72582893|NCT00380874|144696113|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.35||0.9541||95.0|-0.68|0.73|||ANCOVA|||Burning Spontaneous Pain Cycle 7||0.73|-0.68|0.9541
72412756|NCT02019719|144333576|SUPERIORITY_OR_OTHER||E0 (g/dL)|-1.37|||||TWO_SIDED|95.0|-1.72|-1.03|||||Posterior median and 95% credibility intervals were estimated using Bayesian methods.|||-1.03|-1.72|
72412757|NCT02019719|144333576|SUPERIORITY_OR_OTHER||ED50 (mg)|21.88|||||TWO_SIDED|95.0|9.99|42.64|||||Posterior median and 95% credibility intervals were estimated using Bayesian methods.|||42.64|9.99|
72549760|NCT02863575|144629576|SUPERIORITY||LS means difference|0.61||||0.293|TWO_SIDED|95.0|-0.53|1.75|||ANCOVA|||TOTPAR 0-6||1.75|-0.53|0.293
72549761|NCT02863575|144629576|SUPERIORITY||LS means difference|10.93|||<|0.001|TWO_SIDED|95.0|9.3|12.56|||ANCOVA|||TOTPAR 0-6||12.56|9.30|< 0.001
72549762|NCT02863575|144629576|SUPERIORITY||LS means difference|10.32|||<|0.001|TWO_SIDED|95.0|8.69|11.95|||ANCOVA|||TOTPAR 0-6||11.95|8.69|< 0.001
72549763|NCT02863575|144629576|SUPERIORITY||LS means difference|0.58||||0.476|TWO_SIDED|95.0|-1.03|2.19|||ANCOVA|||TOTPAR 0-8||2.19|-1.03|0.476
72549764|NCT02863575|144629576|SUPERIORITY||LS means difference|12.96|||<|0.001|TWO_SIDED|95.0|10.66|15.26|||ANCOVA|||TOTPAR 0-8||15.26|10.66|< 0.001
72549765|NCT02863575|144629576|SUPERIORITY||LS means difference|12.38|||<|0.001|TWO_SIDED|95.0|10.08|14.68|||ANCOVA|||TOTPAR 0-8||14.68|10.08|< 0.001
72549766|NCT02863575|144629577|SUPERIORITY||LS means difference|0.01||||0.975|TWO_SIDED|95.0|-0.35|0.36|||ANCOVA|||PRID at 0.25 hour||0.36|-0.35|0.975
72582894|NCT00380874|144696113|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.3|STANDARD_ERROR_OF_MEAN|0.31||0.3383||95.0|-0.33|0.92|||ANOVA|||Burning Spontaneous Pain Cycle 8||0.92|-0.33|0.3383
72582895|NCT00380874|144696113|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.39||0.8918||95.0|-0.84|0.74|||ANCOVA|||Burning Spontaneous Pain||0.74|-0.84|0.8918
72412758|NCT02019719|144333576|SUPERIORITY_OR_OTHER||Emax (g/dL)|5.88|||||TWO_SIDED|95.0|3.2|8.61|||||Posterior median and 95% credibility intervals were estimated using Bayesian methods.|||8.61|3.20|
72412759|NCT02019719|144333576|SUPERIORITY_OR_OTHER||Gamma|1.13|||||TWO_SIDED|95.0|0.7|1.68|||||Posterior median and 95% credibility intervals were estimated using Bayesian methods.|||1.68|0.70|
72412760|NCT02019719|144333576|SUPERIORITY_OR_OTHER||Var|0.66|||||TWO_SIDED|95.0|0.5|0.88|||||Posterior median and 95% credibility intervals were estimated using Bayesian methods.|||0.88|0.50|
72549767|NCT02863575|144629577|SUPERIORITY||LS means difference|0.12||||0.654|TWO_SIDED|95.0|-0.4|0.63|||ANCOVA|||PRID at 0.25 hour||0.63|-0.40|0.654
72549768|NCT02863575|144629577|SUPERIORITY||LS means difference|0.11||||0.67|TWO_SIDED|95.0|-0.4|0.62|||ANCOVA|||PRID at 0.25 hour||0.62|-0.40|0.670
72549769|NCT02863575|144629577|SUPERIORITY||LS means difference|-0.04||||0.917|TWO_SIDED|95.0|-0.7|0.63|||ANCOVA|||PRID at 0.5 hour||0.63|-0.70|0.917
72549770|NCT02863575|144629577|SUPERIORITY||LS means difference|2.26|||<|0.001|TWO_SIDED|95.0|1.31|3.2|||ANCOVA|||PRID at 0.5 hour||3.20|1.31|< 0.001
72549771|NCT02863575|144629577|SUPERIORITY||LS means difference|2.29|||<|0.001|TWO_SIDED|95.0|1.35|3.24|||ANCOVA|||PRID at 0.5 hour||3.24|1.35|< 0.001
72582896|NCT00380874|144696113|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.26||0.9614||95.0|-0.54|0.51|||ANCOVA|||Burning Spontaneous Pain LOCF endpoint||0.51|-0.54|0.9614
72582897|NCT00380874|144696113|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.06|STANDARD_ERROR_OF_MEAN|0.06||0.3022||95.0|-0.17|0.05|||ANCOVA|||Pressing Spontaneous Pain Cycle 2||0.05|-0.17|0.3022
72582898|NCT00380874|144696113|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.04|STANDARD_ERROR_OF_MEAN|0.04||0.3747||95.0|-0.04|0.12|||ANCOVA|||Pressing Spontaneous Pain Cycle 3||0.12|-0.04|0.3747
72412761|NCT02019719|144333576|SUPERIORITY_OR_OTHER||MED (mg)|1.98|||||TWO_SIDED|95.0|0.75|3.41|||||Posterior median and 95% credibility intervals were estimated using Bayesian methods.|||3.41|0.75|
72549772|NCT02863575|144629577|SUPERIORITY||LS means difference|0.73||||0.039|TWO_SIDED|95.0|0.04|1.42|||ANCOVA|||PRID at 1 hour||1.42|0.04|0.039
72549773|NCT02863575|144629577|SUPERIORITY||LS means difference|6.11|||<|0.001|TWO_SIDED|95.0|5.12|7.1|||ANCOVA|||PRID at 1 hour||7.10|5.12|< 0.001
72549774|NCT02863575|144629577|SUPERIORITY||LS means difference|5.38|||<|0.001|TWO_SIDED|95.0|4.39|6.37|||ANCOVA|||PRID at 1 hour||6.37|4.39|< 0.001
72549775|NCT02863575|144629577|SUPERIORITY||LS means difference|0.84||||0.015|TWO_SIDED|95.0|0.16|1.52|||ANCOVA|||PRID at 1.5 hour||1.52|0.16|0.015
72549776|NCT02863575|144629577|SUPERIORITY||LS means difference|7.36|||<|0.001|TWO_SIDED|95.0|6.39|8.33|||ANCOVA|||PRID at 1.5 hour||8.33|6.39|< 0.001
72549777|NCT02863575|144629577|SUPERIORITY||LS means difference|6.52|||<|0.001|TWO_SIDED|95.0|5.55|7.49|||ANCOVA|||PRID at 1.5 hour||7.49|5.55|< 0.001
72582899|NCT00380874|144696113|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.17|STANDARD_ERROR_OF_MEAN|0.12||0.163||95.0|-0.4|0.07|||ANCOVA|||Pressing Spontaneous Pain Cycle 4||0.07|-0.40|0.1630
72582900|NCT00380874|144696113|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.06||0.9568||95.0|-0.12|0.11|||ANOVA|||Pressing Spontaneous Pain Cycle 5||0.11|-0.12|0.9568
72582901|NCT00380874|144696113|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.07||0.9793||95.0|-0.13|0.13|||ANCOVA|||Pressing Spontaneous Pain Cycle 6||0.13|-0.13|0.9793
72582902|NCT00380874|144696113|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.04|STANDARD_DEVIATION|0.25||0.885||95.0|-0.54|0.47|||ANCOVA|||Pressing Spontaneous Pain Cycle 7||0.47|-0.54|0.8850
72582903|NCT00380874|144696113|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.27|STANDARD_ERROR_OF_MEAN|0.21||0.2199||95.0|-0.17|0.7|||ANCOVA|||Pressing Spontaneous Pain Cycle 8||0.70|-0.17|0.2199
72582904|NCT00380874|144696113|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.12||0.4017||95.0|-0.14|0.35|||ANCOVA|||Pressing Spontaneous Pain Cycle 9||0.35|-0.14|0.4017
72582905|NCT00380874|144696113|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.07|STANDARD_ERROR_OF_MEAN|0.09||0.4113||95.0|-0.1|0.24|||ANCOVA|||Pressing Spontaneous Pain LOCF Endpoint||0.24|-0.10|0.4113
72582906|NCT00380874|144696113|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.02||0.3011||95.0|-0.06|0.02|||ANCOVA|||Paroxysmal Pain Cycle 3||0.02|-0.06|0.3011
72549778|NCT02863575|144629577|SUPERIORITY||LS means difference|0.62||||0.071|TWO_SIDED|95.0|-0.05|1.3|||ANCOVA|||PRID at 2 hour||1.30|-0.05|0.071
72549779|NCT02863575|144629577|SUPERIORITY||LS means difference|7.62|||<|0.001|TWO_SIDED|95.0|6.65|8.58|||ANCOVA|||PRID at 2 hour||8.58|6.65|< 0.001
72549780|NCT02863575|144629577|SUPERIORITY||LS means difference|6.99|||<|0.001|TWO_SIDED|95.0|6.03|7.96|||ANCOVA|||PRID at 2 hour||7.96|6.03|< 0.001
72549781|NCT02863575|144629577|SUPERIORITY||LS means difference|0.41||||0.243|TWO_SIDED|95.0|-0.28|1.09|||ANCOVA|||PRID at 3 hour||1.09|-0.28|0.243
72549782|NCT02863575|144629577|SUPERIORITY||LS means difference|6.83|||<|0.001|TWO_SIDED|95.0|5.85|7.8|||ANCOVA|||PRID at 3 hour||7.80|5.85|< 0.001
72582907|NCT00380874|144696113|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.07|STANDARD_ERROR_OF_MEAN|0.1||0.4482||95.0|-0.26|0.12|||ANCOVA|||Paroxysmal Pain Cycle 4||0.12|-0.26|0.4482
72582908|NCT00380874|144696113|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.11|STANDARD_ERROR_OF_MEAN|0.1||0.3058||95.0|-0.31|0.1|||ANCOVA|||Paroxysmal Pain Cycle 5||0.10|-0.31|0.3058
72582909|NCT00380874|144696113|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.13|STANDARD_ERROR_OF_MEAN|0.12||0.3035||95.0|-0.38|0.12|||ANCOVA|||Paroxysmal Pain Cycle 6||0.12|-0.38|0.3035
72412762|NCT02019719|144333576|SUPERIORITY_OR_OTHER||TD (mg)|3.9|||||TWO_SIDED|95.0|2.2|5.63|||||Posterior median and 95% credibility intervals were estimated using Bayesian methods.|||5.63|2.20|
72549783|NCT02863575|144629577|SUPERIORITY||LS means difference|6.42|||<|0.001|TWO_SIDED|95.0|5.44|7.4|||ANCOVA|||PRID at 3 hour||7.40|5.44|< 0.001
72549784|NCT02863575|144629577|SUPERIORITY||LS means difference|0.08||||0.823|TWO_SIDED|95.0|-0.65|0.82|||ANCOVA|||PRID at 4 hour||0.82|-0.65|0.823
72549785|NCT02863575|144629577|SUPERIORITY||LS means difference|6.08|||<|0.001|TWO_SIDED|95.0|5.02|7.14|||ANCOVA|||PRID at 4 hour||7.14|5.02|< 0.001
72549786|NCT02863575|144629577|SUPERIORITY||LS means difference|6.0|||<|0.001|TWO_SIDED|95.0|4.94|7.05|||ANCOVA|||PRID at 4 hour||7.05|4.94|< 0.001
72549787|NCT02863575|144629577|SUPERIORITY||LS means difference|0.31||||0.438|TWO_SIDED|95.0|-0.48|1.11|||ANCOVA|||PRID at 5 hour||1.11|-0.48|0.438
72549788|NCT02863575|144629577|SUPERIORITY||LS means difference|5.47|||<|0.001|TWO_SIDED|95.0|4.33|6.6|||ANCOVA|||PRID at 5 hour||6.60|4.33|< 0.001
72549789|NCT02863575|144629577|SUPERIORITY||LS means difference|5.15|||<|0.001|TWO_SIDED|95.0|4.01|6.29|||ANCOVA|||PRID at 5 hour||6.29|4.01|< 0.001
72549790|NCT02863575|144629577|SUPERIORITY||LS means difference|0.5||||0.25|TWO_SIDED|95.0|-0.35|1.35|||ANCOVA|||PRID at 6 hour||1.35|-0.35|0.250
72549791|NCT02863575|144629577|SUPERIORITY||LS means difference|4.8|||<|0.001|TWO_SIDED|95.0|3.58|6.02|||ANCOVA|||PRID at 6 hour||6.02|3.58|< 0.001
72549792|NCT02863575|144629577|SUPERIORITY||LS means difference|4.3|||<|0.001|TWO_SIDED|95.0|3.08|5.52|||ANCOVA|||PRID at 6 hour||5.52|3.08|< 0.001
72549793|NCT02863575|144629577|SUPERIORITY||LS means difference|0.11||||0.818|TWO_SIDED|95.0|-0.8|1.01|||ANCOVA|||PRID at 7 hour||1.01|-0.80|0.818
72549794|NCT02863575|144629577|SUPERIORITY||LS means difference|3.53|||<|0.001|TWO_SIDED|95.0|2.23|4.82|||ANCOVA|||PRID at 7 hour||4.82|2.23|< 0.001
72549795|NCT02863575|144629577|SUPERIORITY||LS means difference|3.42|||<|0.001|TWO_SIDED|95.0|2.12|4.71|||ANCOVA|||PRID at 7 hour||4.71|2.12|< 0.001
72549796|NCT02863575|144629577|SUPERIORITY||LS means difference|0.18||||0.698|TWO_SIDED|95.0|-0.74|1.11|||ANCOVA|||PRID at 8 hour||1.11|-0.74|0.698
72582910|NCT00380874|144696113|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.23||0.9636||95.0|-0.46|0.48|||ANCOVA|||Paroxysmal Pain Cycle 7||0.48|-0.46|0.9636
72582911|NCT00380874|144696113|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.32|STANDARD_ERROR_OF_MEAN|0.35||0.366||95.0|-0.38|1.02|||ANCOVA|||Paroxysmal Pain Cycle 8||1.02|-0.38|0.3660
72412763|NCT02019719|144333576|SUPERIORITY_OR_OTHER||MAD (mg)|8.65|||||TWO_SIDED|95.0|6.51|11.44|||||Posterior median and 95% credibility intervals were estimated using Bayesian methods.|||11.44|6.51|
72549797|NCT02863575|144629577|SUPERIORITY||LS means difference|3.02|||<|0.001|TWO_SIDED|95.0|1.69|4.34|||ANCOVA|||PRID at 8 hour||4.34|1.69|< 0.001
72549798|NCT02863575|144629577|SUPERIORITY||LS means difference|2.83|||<|0.001|TWO_SIDED|95.0|1.51|4.16|||ANCOVA|||PRID at 8 hour||4.16|1.51|< 0.001
72549799|NCT02863575|144629578|SUPERIORITY||LS means difference|0.04||||0.575|TWO_SIDED|94.0|-0.09|0.16|||ANCOVA|||PRR score at 0.25 hour||0.16|-0.09|0.575
72549800|NCT02863575|144629578|SUPERIORITY||LS means difference|0.07||||0.426|TWO_SIDED|95.0|-0.11|0.25|||ANCOVA|||PRR score at 0.25 hour||0.25|-0.11|0.426
72549801|NCT02863575|144629578|SUPERIORITY||LS means difference|0.04||||0.686|TWO_SIDED|95.0|-0.14|0.22|||ANCOVA|||PRR score at 0.25 hour||0.22|-0.14|0.686
72549802|NCT02863575|144629578|SUPERIORITY||LS means difference|0.07||||0.543|TWO_SIDED|95.0|-0.15|0.29|||ANCOVA|||PRR score at 0.5 hour||0.29|-0.15|0.543
72549803|NCT02863575|144629578|SUPERIORITY||LS means difference|0.81|||<|0.001|TWO_SIDED|95.0|0.49|1.12|||ANCOVA|||PRR score at 0.5 hour||1.12|0.49|< 0.001
72582912|NCT00380874|144696113|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.24||0.4093||95.0|-0.69|0.29|||ANCOVA|||Paroxysmal Pain Cycle 9||0.29|-0.69|0.4093
72549804|NCT02863575|144629578|SUPERIORITY||LS means difference|0.74|||<|0.001|TWO_SIDED|95.0|0.42|1.05|||ANCOVA|||PRR score at 0.5 hour||1.05|0.42|< 0.001
72549805|NCT02863575|144629578|SUPERIORITY||LS means difference|0.24||||0.038|TWO_SIDED|95.0|0.01|0.46|||ANCOVA|||PRR score at 1 hour||0.46|0.01|0.038
72549806|NCT02863575|144629578|SUPERIORITY||LS means difference|2.01|||<|0.001|TWO_SIDED|95.0|1.69|2.33|||ANCOVA|||PRR score at 1 hour||2.33|1.69|< 0.001
72549807|NCT02863575|144629578|SUPERIORITY||LS means difference|1.78|||<|0.001|TWO_SIDED|95.0|1.46|2.09|||ANCOVA|||PRR score at 1 hour||2.09|1.46|< 0.001
72549808|NCT02863575|144629578|SUPERIORITY||LS means difference|0.25||||0.024|TWO_SIDED|95.0|0.03|0.47|||ANCOVA|||PRR score at 1.5 hour||0.47|0.03|0.024
72549809|NCT02863575|144629578|SUPERIORITY||LS means difference|2.33|||<|0.001|TWO_SIDED|95.0|2.02|2.64|||ANCOVA|||PRR score at 1.5 hour||2.64|2.02|< 0.001
72549810|NCT02863575|144629578|SUPERIORITY||LS means difference|2.08|||<|0.001|TWO_SIDED|95.0|1.77|2.39|||ANCOVA|||PRR score at 1.5 hour||2.39|1.77|< 0.001
72549811|NCT02863575|144629578|SUPERIORITY||LS means difference|0.18||||0.103|TWO_SIDED|95.0|-0.04|0.4|||ANCOVA|||PRR score at 2 hour||0.40|-0.04|0.103
72412764|NCT04535037|144333594|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit (LL) of the 2-sided 95% confidence interval (CI) of group GMC ratio (Infanrix Hexa over Vaxelis group) was above 0.5.|Adjusted GMC Ratio|0.917|||||TWO_SIDED|95.0|0.71|1.185||||The 95% CI for GMC ratio derived from an ANOVA model on log10 transformed concentration was used. GMC was adjusted for DTPA vaccination of the mother.||To demonstrate that the Haemophilus influenzae type b(Hib) response of Infanrix Hexa Group is non-inferior to the Vaxelis Group in terms of anti-PRP GMCs, 1 month post-booster vaccination.||1.185|0.710|
72549812|NCT02863575|144629578|SUPERIORITY||LS means difference|2.4|||<|0.001|TWO_SIDED|95.0|2.09|2.71|||ANCOVA|||PRR score at 2 hour||2.71|2.09|< 0.001
72549813|NCT02863575|144629578|SUPERIORITY||LS means difference|2.22|||<|0.001|TWO_SIDED|95.0|1.91|2.53|||ANCOVA|||PRR score at 2 hour||2.53|1.91|< 0.001
72549814|NCT02863575|144629578|SUPERIORITY||LS means difference|0.08||||0.448|TWO_SIDED|95.0|-0.13|0.29|||ANCOVA|||PRR score at 3 hour||0.29|-0.13|0.448
72549815|NCT02863575|144629578|SUPERIORITY||LS means difference|2.16|||<|0.001|TWO_SIDED|95.0|1.86|2.47|||ANCOVA|||PRR score at 3 hour||2.47|1.86|< 0.001
72549816|NCT02863575|144629578|SUPERIORITY||LS means difference|2.08|||<|0.001|TWO_SIDED|95.0|1.78|2.38|||ANCOVA|||PRR score at 3 hour||2.38|1.78|< 0.001
72549817|NCT02863575|144629578|SUPERIORITY||LS means difference|0.0||||0.997|TWO_SIDED|95.0|-0.23|0.23|||ANCOVA|||PRR score at 4 hour||0.23|-0.23|0.997
72549818|NCT02863575|144629578|SUPERIORITY||LS means difference|1.94|||<|0.001|TWO_SIDED|95.0|1.61|2.28|||ANCOVA|||PRR score at 4 hour||2.28|1.61|< 0.001
72549819|NCT02863575|144629578|SUPERIORITY||LS means difference|1.94|||<|0.001|TWO_SIDED|95.0|1.61|2.28|||ANCOVA|||PRR score at 4 hour||2.28|1.61|< 0.001
72549820|NCT02863575|144629578|SUPERIORITY||LS means difference|0.06||||0.656|TWO_SIDED|95.0|-0.19|0.31|||ANCOVA|||PRR score at 5 hour||0.31|-0.19|0.656
72549821|NCT02863575|144629578|SUPERIORITY||LS means difference|1.73|||<|0.001|TWO_SIDED|95.0|1.36|2.09|||ANCOVA|||PRR score at 5 hour||2.09|1.36|< 0.001
72549822|NCT02863575|144629578|SUPERIORITY||LS means difference|1.67|||<|0.001|TWO_SIDED|95.0|1.31|2.03|||ANCOVA|||PRR score at 5 hour||2.03|1.31|< 0.001
72549823|NCT02863575|144629578|SUPERIORITY||LS means difference|0.11||||0.425|TWO_SIDED|94.0|-0.16|0.38|||ANCOVA|||PRR score at 6 hour||0.38|-0.16|0.425
72549824|NCT02863575|144629578|SUPERIORITY||LS means difference|1.51|||<|0.001|TWO_SIDED|95.0|1.12|1.9|||ANCOVA|||PRR score at 6 hour||1.90|1.12|< 0.001
72549825|NCT02863575|144629578|SUPERIORITY||LS means difference|1.4|||<|0.001|TWO_SIDED|95.0|1.01|1.79|||ANCOVA|||PRR score at 6 hour||1.79|1.01|< 0.001
72549826|NCT02863575|144629578|SUPERIORITY||LS means difference|-0.03||||0.841|TWO_SIDED|95.0|-0.32|0.26|||ANCOVA|||PRR score at 7 hour||0.26|-0.32|0.841
72549827|NCT02863575|144629578|SUPERIORITY||LS means difference|1.1|||<|0.001|TWO_SIDED|95.0|0.69|1.52|||ANCOVA|||PRR score at 7 hour||1.52|0.69|< 0.001
72549828|NCT02863575|144629578|SUPERIORITY||LS means difference|1.13|||<|0.001|TWO_SIDED|95.0|0.72|1.55|||ANCOVA|||PRR score at 7 hour||1.55|0.72|< 0.001
72549829|NCT02863575|144629578|SUPERIORITY||LS means difference|0.0||||0.98||95.0|-0.3|0.3|||ANCOVA|||PRR score at 8 hour||0.30|-0.30|0.980
72549830|NCT02863575|144629578|SUPERIORITY||LS means difference|0.93|||<|0.001|TWO_SIDED|95.0|0.5|1.36|||ANCOVA|||PRR score at 8 hour||1.36|0.50|< 0.001
72549831|NCT02863575|144629578|SUPERIORITY||LS means difference|0.93|||<|0.001|TWO_SIDED|95.0|0.5|1.35|||ANCOVA|||PRR score at 8 hour||1.35|0.50|< 0.001
72549832|NCT02863575|144629579|SUPERIORITY||LS means difference|-0.03||||0.808|TWO_SIDED|95.0|-0.27|0.21|||ANCOVA|||PID score at 0.25 hour||0.21|-0.27|0.808
72549833|NCT02863575|144629579|SUPERIORITY||LS means difference|0.04||||0.804|TWO_SIDED|95.0|-0.3|0.39|||ANCOVA|||PID score at 0.25 hour||0.39|-0.30|0.804
72549834|NCT02863575|144629579|SUPERIORITY||LS means difference|0.07||||0.676|TWO_SIDED|95.0|-0.27|0.42|||ANCOVA|||PID score at 0.25 hr||0.42|-0.27|0.676
72549835|NCT02863575|144629579|SUPERIORITY||LS means difference|-0.1||||0.654|TWO_SIDED|95.0|-0.55|0.35|||ANCOVA|||PID score at 0.5 hour||0.35|-0.55|0.654
72582913|NCT00380874|144696113|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.15||0.5208||95.0|-0.39|0.2|||ANCOVA|||Paroxysmal Pain LOCF Endpoint||0.20|-0.39|0.5208
72412765|NCT04535037|144333595|NON_INFERIORITY|Non-inferiority was demonstrated if the non inferiority of anti-PRP GMC ratio was met and the LL of the 2 sided 95% CI on group difference in the percentage (Infanrix Hexa over Vaxelis group) was more than -10%.|Difference in Percentage|-6.3|||||TWO_SIDED|95.0|-14.1|1.49||||The 2 sided 95% CI of group difference in seroconversion rate (Inv\_group minus Com\_group) was computed based on Miettinen and Nurminen method.||To demonstrate that the Hib response in Infanrix Hexa group is non-inferior to Vaxelis Group in terms of percentage of subjects with anti-PRP antibody concentrations ≥ 5 µg/mL, 1 month post-booster vaccination.||1.49|-14.10|
72412766|NCT02165722|144333629|OTHER|Chi-square tests performed to test for differences in cumulative HPV series initiation vaccination rates from baseline to post-intervention.|||||<|0.001||||||Statistical significance for two-sided tests was set at a type I error (alpha) equal to 0.05.|Chi-squared|Chi-square tests performed to test for differences in cumulative HPV series initiation vaccination rates from baseline to post-intervention.||||||<0.001
72412767|NCT02165722|144333629|OTHER|Chi-square tests performed to test for differences in cumulative HPV series initiation vaccination rates from baseline to post-intervention.|||||<|0.001||||||Statistical significance for two-sided tests was set at a type I error (alpha) equal to 0.05.|Chi-squared|Chi-square tests performed to test for differences in cumulative HPV series initiation vaccination rates from baseline to post-intervention.||||||<0.001
72549836|NCT02863575|144629579|SUPERIORITY||LS means difference|1.45|||<|0.001|TWO_SIDED|95.0|0.81|2.1|||ANCOVA|||PID score at 0.5 hour||2.10|0.81|< 0.001
72549837|NCT02863575|144629579|SUPERIORITY||LS means difference|1.55|||<|0.001|TWO_SIDED|95.0|0.91|2.2|||ANCOVA|||PID score at 0.5 hour||2.20|0.91|< 0.001
72549838|NCT02863575|144629579|SUPERIORITY||LS means difference|0.49||||0.045|TWO_SIDED|95.0|0.01|0.97|||ANCOVA|||PID score at 1 hour||0.97|0.01|0.045
72549839|NCT02863575|144629579|SUPERIORITY||LS means difference|4.1|||<|0.001||95.0|3.41|4.78|||ANCOVA|||PID score at 1 hour||4.78|3.41|< 0.001
72549840|NCT02863575|144629579|SUPERIORITY||LS means difference|3.6|||<|0.001|TWO_SIDED|95.0|2.92|4.29|||ANCOVA|||PID score at 1 hour||4.29|2.92|< 0.001
72549841|NCT02863575|144629579|SUPERIORITY||LS means difference|0.59||||0.015|TWO_SIDED|95.0|0.11|1.06|||ANCOVA|||PID score at 1.5 hour||1.06|0.11|0.015
72549842|NCT02863575|144629579|SUPERIORITY||LS means difference|5.03|||<|0.001|TWO_SIDED|95.0|4.35|5.71|||ANOVA|||PID score at 1.5 hour||5.71|4.35|< 0.001
72549843|NCT02863575|144629579|SUPERIORITY||LS means difference|4.44|||<|0.001|TWO_SIDED|95.0|3.76|5.12|||ANCOVA|||PID score at 1.5 hour||5.12|3.76|< 0.001
72549844|NCT02863575|144629579|SUPERIORITY||LS means difference|0.44||||0.066|TWO_SIDED|95.0|-0.03|0.91|||ANCOVA|||PID score at 2 hour||0.91|-0.03|0.066
72549845|NCT02863575|144629579|SUPERIORITY||LS means difference|5.22|||<|0.001|TWO_SIDED|95.0|4.54|5.89|||ANCOVA|||PID score at 2 hour||5.89|4.54|< 0.001
72549846|NCT02863575|144629579|SUPERIORITY||LS means difference|4.78|||<|0.001|TWO_SIDED|95.0|4.1|5.45|||ANCOVA|||PID score at 2 hour||5.45|4.10|< 0.001
72549847|NCT02863575|144629579|SUPERIORITY||LS means difference|0.32||||0.186|TWO_SIDED|95.0|-0.16|0.81|||ANCOVA|||PID score at 3 hour||0.81|-0.16|0.186
72549848|NCT02863575|144629579|SUPERIORITY||LS means difference|4.66|||<|0.001|TWO_SIDED|95.0|3.98|5.35|||ANCOVA|||PID score at 3 hour||5.35|3.98|< 0.001
72549849|NCT02863575|144629579|SUPERIORITY||LS means difference|4.34|||<|0.001|TWO_SIDED|95.0|3.65|5.03|||ANCOVA|||PID score at 3 hour||5.03|3.65|< 0.001
72549850|NCT02863575|144629579|SUPERIORITY||LS means difference|0.08||||0.75|TWO_SIDED|95.0|-0.43|0.6|||ANCOVA|||PID score at 4 hour||0.60|-0.43|0.750
72549851|NCT02863575|144629579|SUPERIORITY||LS means difference|4.14|||<|0.001|TWO_SIDED|95.0|3.4|4.87|||ANCOVA|||PID score at 4 hour||4.87|3.40|< 0.001
72549852|NCT02863575|144629579|SUPERIORITY||LS means difference|4.05|||<|0.001|TWO_SIDED|95.0|3.32|4.79|||ANCOVA|||PID score at 4 hour||4.79|3.32|< 0.001
72549853|NCT02863575|144629579|SUPERIORITY||LS means difference|0.26||||0.361|TWO_SIDED|95.0|-0.3|0.81|||ANCOVA|||PID score at 5 hour||0.81|-0.30|0.361
72549854|NCT02863575|144629579|SUPERIORITY||LS means difference|3.74|||<|0.001|TWO_SIDED|95.0|2.95|4.53|||ANCOVA|||PID score at 5 hour||4.53|2.95|< 0.001
72549855|NCT02863575|144629579|SUPERIORITY||LS means difference|3.48|||<|0.001|TWO_SIDED|95.0|2.69|4.27|||ANCOVA|||PID score at 5 hour||4.27|2.69|< 0.001
72412768|NCT02165722|144333629|OTHER|Chi-square tests performed to test for differences in cumulative HPV series initiation vaccination rates from baseline to post-intervention between intervention and control clinics.|||||<|0.001||||||Statistical significance for two-sided tests was set at a type I error (alpha) equal to 0.05.|Chi-squared|||Chi-square tests performed to test for differences in cumulative HPV series initiation vaccination rates from baseline to post-intervention between intervention and control clinics.||||<0.001
72412769|NCT02165722|144333629|OTHER|Chi-square tests performed to test for differences in cumulative HPV series initiation vaccination rates from baseline to post-intervention between intervention and control clinics.|||||<|0.001||||||Statistical significance for two-sided tests was set at a type I error (alpha) equal to 0.05.|Chi-squared|||||||<0.001
72412770|NCT02165722|144333630|OTHER|Chi-square tests performed to test for differences in cumulative HPV series completion vaccination rates from baseline to post-intervention.||||||0.001||||||Statistical significance for two-sided tests was set at a type I error (alpha) equal to 0.05.|Chi-squared|Chi-square tests performed to test for differences in cumulative HPV series completion vaccination rates from baseline to post-intervention.||||||0.001
72549856|NCT02863575|144629579|SUPERIORITY||LS means difference|0.39||||0.195|TWO_SIDED|95.0|-0.2|0.98|||ANCOVA|||PID score at 6 hour||0.98|-0.20|0.195
72549857|NCT02863575|144629579|SUPERIORITY||LS means difference|3.29|||<|0.001|TWO_SIDED|95.0|2.44|4.13|||ANCOVA|||PID score at 6 hour||4.13|2.44|< 0.001
72549858|NCT02863575|144629579|SUPERIORITY||LS means difference|2.9|||<|0.001|TWO_SIDED|95.0|2.06|3.74|||ANCOVA|||PID score at 6 hour||3.74|2.06|< 0.001
72549859|NCT02863575|144629579|SUPERIORITY||LS means difference|0.14||||0.669|TWO_SIDED|95.0|-0.49|0.76|||ANCOVA|||PID score at 7 hour||0.76|-0.49|0.669
72549860|NCT02863575|144629579|SUPERIORITY||LS means difference|2.42|||<|0.001|TWO_SIDED|95.0|1.53|3.31|||ANCOVA|||PID score at 7 hour||3.31|1.53|< 0.001
72549861|NCT02863575|144629579|SUPERIORITY||LS means difference|2.29|||<|0.001|TWO_SIDED|95.0|1.4|3.18|||ANCOVA|||PID score at 7 hour||3.18|1.40|< 0.001
72549862|NCT02863575|144629579|SUPERIORITY||LS means difference|0.18||||0.581|TWO_SIDED|95.0|-0.46|0.82|||ANCOVA|||PID score at 8 hour||0.82|-0.46|0.581
72549863|NCT02863575|144629579|SUPERIORITY||LS means difference|2.09|||<|0.001|TWO_SIDED|95.0|1.18|3.0|||ANCOVA|||PID score at 8 hour||3.00|1.18|< 0.001
72549864|NCT02863575|144629579|SUPERIORITY||LS means difference|1.91|||<|0.001|TWO_SIDED|95.0|1.0|2.82|||ANCOVA|||PID score at 8 hour||2.82|1.00|< 0.001
72549865|NCT02863575|144629580|SUPERIORITY|||||||0.028|||||||Gehan-Wilcoxon test|P-value was calculated using the Gehan-Wilcoxon test, stratified by gender and baseline categorical pain severity terms.||||||0.028
72549866|NCT02863575|144629580|SUPERIORITY||||||<|0.001|||||||Gehan-Wilcoxon test|P-value was calculated using the Gehan-Wilcoxon test, stratified by gender and baseline categorical pain severity terms.||||||<0.001
72549867|NCT02863575|144629580|SUPERIORITY||||||<|0.001|||||||Gehan-Wilcoxon test|P-value was calculated using the Gehan-Wilcoxon test, stratified by gender and baseline categorical pain severity terms.||||||<0.001
72549868|NCT02863575|144629581|SUPERIORITY|||||||0.861|||||||Gehan-Wilcoxon test|P-value was calculated using the Gehan-Wilcoxon test, stratified by gender and baseline categorical pain severity terms.||||||0.861
72549869|NCT02863575|144629581|SUPERIORITY||||||<|0.001|||||||Gehan-Wilcoxon test|P-value was calculated using the Gehan-Wilcoxon test, stratified by gender and baseline categorical pain severity terms.||||||<0.001
72549870|NCT02863575|144629581|SUPERIORITY||||||<|0.001|||||||Gehan-Wilcoxon test|P-value was calculated using the Gehan-Wilcoxon test, stratified by gender and baseline categorical pain severity terms.||||||<0.001
72549871|NCT02863575|144629582|SUPERIORITY|||||||0.838|||||||Gehan-Wilcoxon test|P-value was calculated using the Gehan-Wilcoxon test, stratified by gender and baseline categorical pain severity terms.||||||0.838
72549872|NCT02863575|144629582|SUPERIORITY||||||<|0.001|||||||Gehan-Wilcoxon test|P-value was calculated using the Gehan-Wilcoxon test, stratified by gender and baseline categorical pain severity terms.||||||<0.001
72549873|NCT02863575|144629582|SUPERIORITY||||||<|0.001|||||||Gehan-Wilcoxon test|P-value was calculated using the Gehan-Wilcoxon test, stratified by gender and baseline categorical pain severity terms.||||||<0.001
72549874|NCT03900624|144629595|SUPERIORITY|||||||0.632|||||||Wilcoxon (Mann-Whitney)|||||||0.632
72549875|NCT03900624|144629596|SUPERIORITY|||||||0.725|||||||Wilcoxon (Mann-Whitney)|||||||0.725
72549876|NCT03900624|144629597|SUPERIORITY|||||||0.725|||||||Wilcoxon (Mann-Whitney)|||||||0.725
72549877|NCT01494506|144629613|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.99||||0.9416|TWO_SIDED|95.0|0.77|1.28|||Log Rank|Unstratified logrank test.||||1.28|0.77|0.9416
72549878|NCT01494506|144629613|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.67||||0.012|TWO_SIDED|95.0|0.49|0.92|||Log Rank|Unstratified logrank test.||||0.92|0.49|0.012
72549879|NCT01494506|144629614|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.81||||0.1|TWO_SIDED|95.0|0.63|1.04|||Log Rank|||||1.04|0.63|0.100
72549880|NCT01494506|144629614|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.56|||<|0.001|TWO_SIDED|95.0|0.41|0.75|||Log Rank|||||0.75|0.41|<0.001
72549881|NCT01494506|144629615|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.0264||||0.214|TWO_SIDED|95.0|-0.005|0.058|||Fisher Exact|||||0.058|-0.005|0.214
72549882|NCT01494506|144629615|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.069||||0.01|TWO_SIDED|95.0|0.018|0.12|||Fisher Exact|||||0.120|0.018|0.010
72549883|NCT01494506|144629616|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.82||||0.1008|TWO_SIDED|95.0|0.65|1.03|||Log Rank|Unstratified log rank test.||||1.03|0.65|0.1008
72549884|NCT01494506|144629616|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.6||||0.0002|TWO_SIDED|95.0|0.45|0.78|||Log Rank|Unstratified log rank test||||0.78|0.45|0.0002
72549885|NCT01494506|144629617|SUPERIORITY_OR_OTHER|||||||0.82|||||||Fisher Exact|||||||0.82
72412771|NCT02165722|144333630|OTHER|Chi-square tests performed to test for differences in cumulative HPV series completion vaccination rates from baseline to post-intervention.|||||>|0.05||||||Statistical significance for two-sided tests was set at a type I error (alpha) equal to 0.05.|Chi-squared|||||||>0.05
72549886|NCT01494506|144629617|SUPERIORITY_OR_OTHER|||||||0.8|||||||Fisher Exact|||||||0.80
72549887|NCT01494506|144629618|SUPERIORITY_OR_OTHER|||||||0.024|||||||Fisher Exact|||||||0.024
72549888|NCT01494506|144629618|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Fisher Exact|||||||<0.001
72549889|NCT01494506|144629619|SUPERIORITY_OR_OTHER|||||||0.6388||||||For each experimental arm comparison p-values were adjusted for multiple domain comparisons using the Hochberg method.|Cochran-Mantel-Haenszel|||Comparison of Global Health Status||||0.6388
72549890|NCT01494506|144629619|SUPERIORITY_OR_OTHER|||||||0.8445||||||For each experimental arm comparison p-values were adjusted for multiple domain comparisons using the Hochberg method.|Cochran-Mantel-Haenszel|||Comparison of Global Health Status||||0.8445
72549891|NCT01494506|144629619|SUPERIORITY_OR_OTHER|||||||0.6388||||||For each experimental arm comparison p-values were adjusted for multiple domain comparisons using the Hochberg method.|Cochran-Mantel-Haenszel|||Comparison of Physical Functioning||||0.6388
72549892|NCT01494506|144629619|SUPERIORITY_OR_OTHER|||||||0.9435||||||For each experimental arm comparison p-values were adjusted for multiple domain comparisons using the Hochberg method.|Cochran-Mantel-Haenszel|||Comparison of Physical Functioning||||0.9435
72582914|NCT00380874|144696113|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.08||0.9931||95.0|-0.17|0.17|||ANCOVA|||Evoke Pain Cycle 2||0.17|-0.17|0.9931
72549893|NCT01494506|144629619|SUPERIORITY_OR_OTHER|||||||0.2654||||||For each experimental arm comparison p-values were adjusted for multiple domain comparisons using the Hochberg method.|Cochran-Mantel-Haenszel|||Comparison of Role functioning||||0.2654
72549894|NCT01494506|144629619|SUPERIORITY_OR_OTHER|||||||0.7674||||||For each experimental arm comparison p-values were adjusted for multiple domain comparisons using the Hochberg method.|Cochran-Mantel-Haenszel|||Comparison of Role functioning||||0.7674
72549895|NCT01494506|144629619|SUPERIORITY_OR_OTHER|||||||0.1628||||||For each experimental arm comparison p-values were adjusted for multiple domain comparisons using the Hochberg method.|Cochran-Mantel-Haenszel|||Comparison of Emotional Functioning||||0.1628
72549896|NCT01494506|144629619|SUPERIORITY_OR_OTHER|||||||0.6712||||||For each experimental arm comparison p-values were adjusted for multiple domain comparisons using the Hochberg method.|Cochran-Mantel-Haenszel|||Comparison of Emotional Functioning||||0.6712
72549897|NCT01494506|144629619|SUPERIORITY_OR_OTHER|||||||0.7738||||||For each experimental arm comparison p-values were adjusted for multiple domain comparisons using the Hochberg method.|Cochran-Mantel-Haenszel|||Comparison of Cognitive Functioning||||0.7738
72582915|NCT00380874|144696113|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.09|STANDARD_ERROR_OF_MEAN|0.17||0.5867||95.0|-0.25|0.44|||ANCOVA|||Evoke Pain Cycle 3||0.44|-0.25|0.5867
72582916|NCT00380874|144696113|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.13|STANDARD_ERROR_OF_MEAN|0.12||0.2748||95.0|-0.37|0.11|||ANCOVA|||Evoke Pain Cycle 4||0.11|-0.37|0.2748
72582917|NCT00380874|144696113|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.12|STANDARD_ERROR_OF_MEAN|0.2||0.5521||95.0|-0.51|0.28|||ANCOVA|||Evoke Pain Cycle 5||0.28|-0.51|0.5521
72582918|NCT00380874|144696113|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.17|STANDARD_ERROR_OF_MEAN|0.39||0.6734||95.0|-0.96|0.62|||ANCOVA|||Evoke Pain Cycle 6||0.62|-0.96|0.6734
72582919|NCT00380874|144696113|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.58|STANDARD_ERROR_OF_MEAN|0.37||0.1214||95.0|-0.16|1.33|||ANCOVA|||Evoke Pain Cycle 7||1.33|-0.16|0.1214
72582920|NCT00380874|144696113|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.69|STANDARD_ERROR_OF_MEAN|0.51||0.1845||95.0|-0.34|1.72|||ANCOVA|||Evoke Pain Cycle 8||1.72|-0.34|0.1845
72412772|NCT02165722|144333630|OTHER|Chi-square tests performed to test for differences in cumulative HPV series completion vaccination rates from baseline to post-intervention between intervention and control clinics.|||||>|0.05||||||Statistical significance for two-sided tests was set at a type I error (alpha) equal to 0.05.|Chi-squared|||||||>0.05
72549898|NCT01494506|144629619|SUPERIORITY_OR_OTHER|||||||0.6712||||||For each experimental arm comparison p-values were adjusted for multiple domain comparisons using the Hochberg method.|Cochran-Mantel-Haenszel|||Comparison of Cognitive Functioning||||0.6712
72549899|NCT01494506|144629619|SUPERIORITY_OR_OTHER|||||||0.3408||||||For each experimental arm comparison p-values were adjusted for multiple domain comparisons using the Hochberg method.|Cochran-Mantel-Haenszel|||Comparison of Social Functioning||||0.3408
72549900|NCT01494506|144629619|SUPERIORITY_OR_OTHER|||||||0.6712||||||For each experimental arm comparison p-values were adjusted for multiple domain comparisons using the Hochberg method.|Cochran-Mantel-Haenszel|||Comparison of Social Functioning||||0.6712
72549901|NCT01494506|144629619|SUPERIORITY_OR_OTHER|||||||0.6766||||||For each experimental arm comparison p-values were adjusted for multiple domain comparisons using the Hochberg method.|Cochran-Mantel-Haenszel|||Comparison of Fatigue||||0.6766
72549902|NCT01494506|144629619|SUPERIORITY_OR_OTHER|||||||0.6712||||||For each experimental arm comparison p-values were adjusted for multiple domain comparisons using the Hochberg method.|Cochran-Mantel-Haenszel|||Comparison of Fatigue||||0.6712
72549903|NCT01494506|144629619|SUPERIORITY_OR_OTHER|||||||0.6388||||||For each experimental arm comparison p-values were adjusted for multiple domain comparisons using the Hochberg method.|Cochran-Mantel-Haenszel|||Comparison of Nausea and Vomiting||||0.6388
72549904|NCT01494506|144629619|SUPERIORITY_OR_OTHER|||||||0.7674||||||For each experimental arm comparison p-values were adjusted for multiple domain comparisons using the Hochberg method.|Cochran-Mantel-Haenszel|||Comparison of Nausea and Vomiting||||0.7674
72549905|NCT01494506|144629619|SUPERIORITY_OR_OTHER|||||||0.4993||||||For each experimental arm comparison p-values were adjusted for multiple domain comparisons using the Hochberg method.|Cochran-Mantel-Haenszel|||Comparison of Pain||||0.4993
72549906|NCT01494506|144629619|SUPERIORITY_OR_OTHER|||||||0.6712||||||For each experimental arm comparison p-values were adjusted for multiple domain comparisons using the Hochberg method.|Cochran-Mantel-Haenszel|||Comparison of Pain||||0.6712
72549907|NCT01494506|144629619|SUPERIORITY_OR_OTHER|||||||0.2654||||||For each experimental arm comparison p-values were adjusted for multiple domain comparisons using the Hochberg method.|Cochran-Mantel-Haenszel|||Comparison of Dyspnoea||||0.2654
72549908|NCT01494506|144629619|SUPERIORITY_OR_OTHER|||||||0.6712||||||For each experimental arm comparison p-values were adjusted for multiple domain comparisons using the Hochberg method.|Cochran-Mantel-Haenszel|||Comparison of Dyspnoea||||0.6712
72549909|NCT01494506|144629619|SUPERIORITY_OR_OTHER|||||||0.7617||||||For each experimental arm comparison p-values were adjusted for multiple domain comparisons using the Hochberg method.|Cochran-Mantel-Haenszel|||Comparison of Insomnia||||0.7617
72549910|NCT01494506|144629619|SUPERIORITY_OR_OTHER|||||||0.6712|||||||Cochran-Mantel-Haenszel|||Comparison of Insomnia||||0.6712
72549911|NCT01494506|144629619|SUPERIORITY_OR_OTHER|||||||0.9123||||||For each experimental arm comparison p-values were adjusted for multiple domain comparisons using the Hochberg method.|Cochran-Mantel-Haenszel|||Comparison of Appetite loss||||0.9123
72549912|NCT01494506|144629619|SUPERIORITY_OR_OTHER|||||||0.6712||||||For each experimental arm comparison p-values were adjusted for multiple domain comparisons using the Hochberg method.|Cochran-Mantel-Haenszel|||Comparison of Appetite loss||||0.6712
72582921|NCT00380874|144696113|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.15|STANDARD_ERROR_OF_MEAN|0.37||0.6863||95.0|-0.6|0.9|||ANCOVA|||Evoke Pain Cycle 9||0.90|-0.60|0.6863
72582922|NCT00380874|144696113|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.27||0.9273||95.0|-0.51|0.56|||ANCOVA|||Evoke Pain LOCF Endpoint||0.56|-0.51|0.9273
72582923|NCT00380874|144696113|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.25|STANDARD_ERROR_OF_MEAN|0.12||0.0416||95.0|0.01|0.5|||ANCOVA|||Parethesia/Dysesthesia Pain Cycle 2||0.50|0.01|0.0416
72582924|NCT00380874|144696113|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|0.15||0.1819||95.0|-0.1|0.5|||ANCOVA|||Parethesia/Dysesthesia Pain Cycle 3||0.50|-0.10|0.1819
72582925|NCT00380874|144696113|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.37|STANDARD_ERROR_OF_MEAN|0.17||0.0331||95.0|0.03|0.7|||ANCOVA|||Parethesia/Dysesthesia Pain Cycle 4||0.70|0.03|0.0331
72582926|NCT00380874|144696113|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.4|STANDARD_ERROR_OF_MEAN|0.21||0.0608||95.0|-0.02|0.83|||ANCOVA|||Parethesia/Dysesthesia Pain Cycle 5||0.83|-0.02|0.0608
72582927|NCT00380874|144696113|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.36|STANDARD_ERROR_OF_MEAN|0.33||0.2809||95.0|-0.31|1.03|||ANCOVA|||Parethesia/Dysesthesia Pain Cycle 6||1.03|-0.31|0.2809
72582928|NCT00380874|144696113|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.31|STANDARD_ERROR_OF_MEAN|0.32||0.3445||95.0|-0.34|0.95|||ANCOVA|||Parethesia/Dysesthesia Pain Cycle 7||0.95|-0.34|0.3445
72582929|NCT00380874|144696113|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.51|STANDARD_ERROR_OF_MEAN|0.47||0.2806||95.0|-0.44|1.46|||ANCOVA|||Parethesia/Dysesthesia Pain Cycle 8||1.46|-0.44|0.2806
72549913|NCT01494506|144629619|SUPERIORITY_OR_OTHER|||||||0.7617||||||For each experimental arm comparison p-values were adjusted for multiple domain comparisons using the Hochberg method.|Cochran-Mantel-Haenszel|||Comparison of Constipation||||0.7617
72549914|NCT01494506|144629619|SUPERIORITY_OR_OTHER|||||||0.6712||||||For each experimental arm comparison p-values were adjusted for multiple domain comparisons using the Hochberg method.|Cochran-Mantel-Haenszel|||Comparison of Constipation||||0.6712
72549915|NCT01494506|144629619|SUPERIORITY_OR_OTHER|||||||0.1628||||||For each experimental arm comparison p-values were adjusted for multiple domain comparisons using the Hochberg method.|Cochran-Mantel-Haenszel|||Comparison of Diarrhoea||||0.1628
72582930|NCT00380874|144696113|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.32|STANDARD_ERROR_OF_MEAN|0.49||0.5217||95.0|-0.68|1.33|||ANCOVA|||Parethesia/Dysesthesia Pain Cycle 9||1.33|-0.68|0.5217
72582931|NCT00380874|144696113|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.31|STANDARD_ERROR_OF_MEAN|0.34||0.3628||95.0|-0.37|1.0|||ANCOVA|||Parethesia/Dysesthesia Pain LOCF Endpoint||1.00|-0.37|0.3628
72582932|NCT00380874|144696113|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.0||0.3557||95.0|0.0|0.01|||ANCOVA|||Total Score Cycle 2||0.01|-0.00|0.3557
72582933|NCT00380874|144696113|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.0||0.2824||95.0|0.0|0.01|||ANCOVA|||Total Score Cycle 3||0.01|-0.00|0.2824
72582934|NCT00380874|144696113|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.0||0.5931||95.0|-0.01|0.01|||ANCOVA|||Total Score Cycle 4||0.01|-0.01|0.5931
72582935|NCT00380874|144696113|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.0||0.9865||95.0|-0.01|0.01|||ANCOVA|||Total Score Cycle 5||0.01|-0.01|0.9865
72582936|NCT00380874|144696113|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.01||0.9854||95.0|-0.02|0.02|||ANCOVA|||Total Score Cycle 6||0.02|-0.02|0.9854
72582937|NCT00380874|144696113|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.01||0.3403||95.0|-0.01|0.04|||ANCOVA|||Total Score Cycle 7||0.04|-0.01|0.3403
72582938|NCT00380874|144696113|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.02||0.2226||95.0|-0.01|0.05|||ANCOVA|||Total Score Cycle 8||0.05|-0.01|0.2226
72582939|NCT00380874|144696113|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.01||0.9694||95.0|-0.03|0.03|||ANCOVA|||Total Score Cycle 9||0.03|-0.03|0.9694
72582940|NCT00380874|144696113|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.01||0.8957||95.0|-0.02|0.02|||ANCOVA|||Total Score LOCF Endpoint||0.02|-0.02|0.8957
72582941|NCT00380874|144696115|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-0.16|STANDARD_ERROR_OF_MEAN|0.49||0.7489||95.0||||No multiple comparisons adjustment was necessary.|ANCOVA|Model terms include treatment, study center, and baseline score.|Least squares (LS) means and corresponding standard errors derived from ANCOVA model were used.|LOCF cycle endpoint. Sample size based on original primary efficacy parameter (PEP) of time to persistent symptoms (developing in 35% of pregabalin subjects \& 60% of placebo subjects). Assuming Type I error rate of 0.05 and a 2-sided log-rank test for equality of time to persistent symptoms survival curves, study would have had at least 90% power using 100 subjects per treatment group. Original PEP was modified to secondary due to lack of persistent paresthetic symptom emergence.||||0.7489
72582942|NCT01451463|144696164|SUPERIORITY_OR_OTHER|||||||0.009|||||||t-test, 2 sided|||||||.009
72582943|NCT01451463|144696165|SUPERIORITY_OR_OTHER|||||||0.114|||||||t-test, 2 sided|||||||.114
72582944|NCT03918629|144696185|NON_INFERIORITY|The noninferiority objective was achieved if the lower limit of the 95% CI for geometric mean ratio (GMR) was \>0.67 for both Toxin A and Toxin B.|Adjusted Geometric Mean Ratio|0.82|||||TWO_SIDED|95.0|0.74|0.9|||||Adjusted geometric mean ratio (GMR) was estimated by the ratio of the adjusted GMCs (adjusted for baseline concentrations). CIs based on the student t distribution for the mean or the mean difference in logarithmic scale.|Toxin A||0.90|0.74|
72582945|NCT03918629|144696185|NON_INFERIORITY|The noninferiority objective was achieved if the lower limit of the 95% CI for GMR was \>0.67 for both Toxin A and Toxin B.|Adjusted Geometric Mean Ratio|0.57|||||TWO_SIDED|95.0|0.49|0.66|||||Adjusted GMR was estimated by the ratio of the adjusted GMCs (adjusted for baseline concentrations). CIs based on the student t distribution for the mean difference in logarithmic scale.|Toxin B||0.66|0.49|
72582946|NCT03918629|144696186|NON_INFERIORITY|The noninferiority objective was achieved if the lower limit of the 95% CI for the difference was \>-10% for both Toxin A and Toxin B.|Percentage difference|-1.8|||||TWO_SIDED|95.0|-6.4|2.9|||||The difference (2-Dose - 3-Dose) and the associated 95% CIs for the difference were calculated using the Miettinen and Nurminen method.|Toxin A||2.9|-6.4|
72549916|NCT01494506|144629619|SUPERIORITY_OR_OTHER|||||||0.6712||||||For each experimental arm comparison p-values were adjusted for multiple domain comparisons using the Hochberg method.|Cochran-Mantel-Haenszel|||Comparison of Diarrhoea||||0.6712
72549917|NCT01494506|144629619|SUPERIORITY_OR_OTHER|||||||0.6388||||||For each experimental arm comparison p-values were adjusted for multiple domain comparisons using the Hochberg method.|Cochran-Mantel-Haenszel|||Comparison of Financial difficulties||||0.6388
72582947|NCT03918629|144696186|NON_INFERIORITY|The noninferiority objective was achieved if the lower limit of the 95% CI for the difference was \>-10% for both Toxin A and Toxin B.|Percentage difference|-16.8|||||TWO_SIDED|95.0|-21.3|-12.2|||||The difference (2-Dose - 3-Dose) and the associated 95% CIs for the difference were calculated using the Miettinen and Nurminen method.|Toxin B||-12.2|-21.3|
72582948|NCT03918629|144696195|NON_INFERIORITY|The noninferiority objective was achieved if the lower limit of the 95% CI for GMR was \>0.67 for both Toxin A and Toxin B.|Adjusted Geometric Mean Ratio|0.87|||||TWO_SIDED|95.0|0.8|0.95|||||Adjusted GMR was estimated by the ratio of the adjusted GMCs (adjusted for baseline concentrations). CIs based on the student t distribution for the mean or the mean difference in logarithmic scale.|Toxin A||0.95|0.80|
72549918|NCT01494506|144629619|SUPERIORITY_OR_OTHER|||||||0.7308||||||For each experimental arm comparison p-values were adjusted for multiple domain comparisons using the Hochberg method.|Cochran-Mantel-Haenszel|||Comparison of Financial difficulties||||0.7308
72549919|NCT05216081|144629622|OTHER||Percentage of enrolled from eligible|69.4|||||TWO_SIDED|95.0|61.5|76.2||||||||76.2|61.5|
72549920|NCT05216081|144629623|OTHER||Percentage of enrolled from eligible|99.0|||||TWO_SIDED|95.0|94.7|99.8||||||||99.8|94.7|
72549921|NCT05216081|144629625|OTHER||Percentage screened positive for EM|15.8|||||TWO_SIDED|95.0|10.0|24.2||||||||24.2|10|
72549922|NCT05216081|144629628|OTHER||Percentage who self-disclosed|57.1|||||TWO_SIDED|95.0|32.6|78.6||||||||78.6|32.6|
72549923|NCT05216081|144629629|OTHER||Percentage substantiated by socialworker|75.0|||||TWO_SIDED|95.0|50.5|89.8||||||||89.8|50.5|
72549924|NCT02777528|144629643|OTHER|Performance goal tested using Exact method calculation to estimate the 95% one-sided lower confidence level (95% LCL) on the proportion of participants with primary endpoint success. If the 95% LCL exceeded 0.60, then the null hypothesis was to be rejected and the PG was met.|95% Exact Lower Confidence Limit|0.745|||||TWO_SIDED|||||||||"Primary endpoint success was defined as the proportion of analysis-eligible participants without a primary endpoint event and with 1-Month imaging performed.~Results were tested against a performance goal (PG) of 0.60 (i.e. 60%), derived from outcomes from a systematic review of hybrid TEVAR repair literature.~Additionally, using a one-sided alpha of 0.05 and Exact Test, minimum power of 80%, the sample needed was 50 patients."||||
72549925|NCT03100903|144629645|OTHER|The statistical model was an analysis of variance (ANOVA) model on the logarithmic scale, accounting for the treatment group as a source of variation. The effect 'treatment group' was considered as fixed.|Geometric Mean ratio (%)|71.64|||||TWO_SIDED|90.0|60.57|84.73|||||"gMean ratio = gMean of BI 655130 high dose SC/gMean of BI 655130 high dose IV.~Inter-individual geometric coefficient of variation (gCV) \[%\] = 23.7"|||84.73|60.57|
72549926|NCT03100903|144629646|OTHER|The statistical model was an analysis of variance (ANOVA) model on the logarithmic scale, accounting for the treatment group as a source of variation. The effect 'treatment group' was considered as fixed.|Geometric Mean (gMean) Ratio %|29.29|||||TWO_SIDED|90.0|24.27|35.35|||||"gMean ratio = gMean of BI 655130 high dose SC/gMean of BI 655130 high dose IV.~Inter-individual geometric coefficient of variation (gCV) \[%\] = 26.6"|||35.35|24.27|
72549927|NCT03100903|144629647|OTHER|The statistical model was an analysis of variance (ANOVA) model on the logarithmic scale, accounting for the treatment group as a source of variation. The effect 'treatment group' was considered as fixed.|Geometric Mean (gMean) Ratio %|70.22|||||TWO_SIDED|90.0|59.26|83.2|||||"gMean ratio = gMean of BI 655130 high dose SC/gMean of BI 655130 high dose IV.~Inter-individual geometric coefficient of variation (gCV) \[%\] = 23.9"|||83.20|59.26|
72549928|NCT01492361|144629651|SUPERIORITY||Hazard Ratio (HR)|0.75||||1e-08|TWO_SIDED|95.0|0.68|0.83||The 2-sided alpha level for the primary analysis was adjusted to 0.0437 from 0.05 to account for the two interim analyses based on a group sequential design with O'Brien-Fleming boundaries generated using the Lan-DeMets alpha-spending function.|Log Rank|Stratified by CV risk category, use of ezetimibe, and geographical region||||0.83|0.68|0.00000001
72549929|NCT01492361|144629652|SUPERIORITY||Hazard Ratio (HR)|0.74||||6e-07|TWO_SIDED|95.0|0.65|0.83||Prespecified secondary end points were tested in a hierarchical fashion, in the order listed here, at the final alpha level of 0.0437.|Log Rank|Stratified by CV risk category, use of ezetimibe, and geographical region.||||0.83|0.65|0.0000006
72549930|NCT01492361|144629653|SUPERIORITY||Hazard Ratio (HR)|0.75|||<|0.0001|TWO_SIDED|95.0|0.66|0.86||Prespecified secondary end points were tested in a hierarchical fashion, in the order listed here, at the final alpha level of 0.0437.|Log Rank|Stratified by CV risk category, use of ezetimibe, and geographical region.||||0.86|0.66|<0.0001
72549931|NCT01492361|144629654|SUPERIORITY||Hazard Ratio (HR)|0.69|||<|0.0001|TWO_SIDED|95.0|0.58|0.81||Prespecified secondary end points were tested in a hierarchical fashion, in the order listed here, at the final alpha level of 0.0437.|Log Rank|Stratified by CV risk category, use of ezetimibe, and geographical region.||||0.81|0.58|<0.0001
72549932|NCT01492361|144629655|SUPERIORITY||Hazard Ratio (HR)|0.65|||<|0.0001|TWO_SIDED|95.0|0.55|0.78||Prespecified secondary end points were tested in a hierarchical fashion, in the order listed here, at the final alpha level of 0.0437.|Log Rank|Stratified by CV risk category, use of ezetimibe, and geographical region.||||0.78|0.55|<0.0001
72549933|NCT01492361|144629656|SUPERIORITY||Hazard Ratio (HR)|0.8||||0.0315|TWO_SIDED|95.0|0.66|0.98||Prespecified secondary end points were tested in a hierarchical fashion, in the order listed here, at the final alpha level of 0.0437.|Log Rank|Stratified by CV risk category, use of ezetimibe, and geographical region.||||0.98|0.66|0.0315
72549934|NCT01492361|144629657|SUPERIORITY||Hazard Ratio (HR)|0.68||||0.0018|TWO_SIDED|95.0|0.53|0.87||Prespecified secondary end points were tested in a hierarchical fashion, in the order listed here, at the final alpha level of 0.0437.|Log Rank|Stratified by CV risk category, use of ezetimibe, and geographical region.||||0.87|0.53|0.0018
72549935|NCT01492361|144629658|SUPERIORITY||Hazard Ratio (HR)|0.72||||0.0129|TWO_SIDED|95.0|0.55|0.93||Prespecified secondary end points were tested in a hierarchical fashion, in the order listed here, at the final alpha level of 0.0437.|Log Rank|Stratified by CV risk category, use of ezetimibe, and geographical region.||||0.93|0.55|0.0129
72582949|NCT03918629|144696195|NON_INFERIORITY|The noninferiority objective was achieved if the lower limit of the 95% CI for GMR was \>0.67 for both Toxin A and Toxin B.|Adjusted Geometric Mean Ratio|0.71|||||TWO_SIDED|95.0|0.62|0.81|||||Adjusted GMR was estimated by the ratio of the adjusted GMCs (adjusted for baseline concentrations). CIs based on the student t distribution for the mean or the mean difference in logarithmic scale.|Toxin B||0.81|0.62|
72582950|NCT03918629|144696196|NON_INFERIORITY|The noninferiority objective was achieved if the lower limit of the 95% CI for the difference was \>-10% for both Toxin A and Toxin B.|Percentage difference|-1.0|||||TWO_SIDED|95.0|-3.7|1.7|||||The difference (2-Dose - 3-Dose) and the associated 95% CIs for the difference were calculated using the Miettinen and Nurminen method.|Toxin A||1.7|-3.7|
72549936|NCT01492361|144629659|SUPERIORITY||Hazard Ratio (HR)|0.77|||<|0.0001|TWO_SIDED|95.0|0.69|0.86||Prespecified secondary end points were tested in a hierarchical fashion, in the order listed here, at the final alpha level of 0.0437.|Log Rank|Stratified by CV risk category, use of ezetimibe, and geographical region.||||0.86|0.69|<0.0001
72549937|NCT01492361|144629660|SUPERIORITY||Hazard Ratio (HR)|0.87||||0.0915|TWO_SIDED|95.0|0.74|1.02||Prespecified secondary end points were tested in a hierarchical fashion, in the order listed here, at the final alpha level of 0.0437.|Log Rank|Stratified by CV risk category, use of ezetimibe, and geographical region.||||1.02|0.74|0.0915
72412773|NCT02165722|144333630|OTHER|Chi-square tests performed to test for differences in cumulative HPV series completion vaccination rates from baseline to post-intervention between intervention and control clinics.|||||>|0.05||||||Statistical significance for two-sided tests was set at a type I error (alpha) equal to 0.05.|Chi-squared|||||||>0.05
72412774|NCT02731131|144333639|SUPERIORITY_OR_OTHER|||||||0.3|||||||Fisher Exact|||||||0.30
72549938|NCT01249664|144629691|SUPERIORITY_OR_OTHER||Difference in least square means|14.1|||<|0.0001|TWO_SIDED|95.0|10.8|17.4||No adjustment on P value, this is for the primary efficacy analysis.|ANCOVA|ANCOVA model, including treatment groups and country (country designations) as fixed effects and baseline BCVA as a covariate.|The difference is calculated as Eylea minus Sham. A positive value indicates Eylea showed a higher change in BCVA total score until week 24 compared to Sham.|Null hypothesis was equality in change from baseline to Week 24 in BCVA total letter score between Eylea and Sham.||17.4|10.8|<0.0001
72549939|NCT01249664|144629692|SUPERIORITY_OR_OTHER||CMH adjusted difference|29.2||||0.0001|TWO_SIDED|95.0|14.4|44.0||No adjustment on P value, since this test was only conducted formally under the primary efficacy evaluation was significant.|Cochran-Mantel-Haenszel||A two-sided Cochran-Mantel-Haenszel method at level 5% weight-adjusted by country (country designations) was used to conduct the superiority test.|Null hypothesis of difference of Eylea minus Sham of 0 was tested.||44.0|14.4|0.0001
72549940|NCT01249664|144629693|SUPERIORITY_OR_OTHER||Difference in least square means|13.1|||<|0.0001|TWO_SIDED|95.0|9.4|16.7|||ANCOVA|||||16.7|9.4|<0.0001
72549941|NCT01249664|144629694|SUPERIORITY_OR_OTHER||CMH adjusted difference|50.5|||<|0.001|TWO_SIDED|95.0|35.0|66.0|||Cochran-Mantel-Haenszel|||||66.0|35.0|<0.001
72549942|NCT01249664|144629695|SUPERIORITY_OR_OTHER||CMH adjusted difference|64.0|||<|0.001|TWO_SIDED|95.0|47.8|80.3|||Cochran-Mantel-Haenszel|||||80.3|47.8|<0.001
72549943|NCT01249664|144629696|SUPERIORITY_OR_OTHER||CMH adjusted difference|21.0||||0.0308|TWO_SIDED|95.0|1.9|40.1|||Cochran-Mantel-Haenszel|||||40.1|1.9|0.0308
72549944|NCT01249664|144629697|SUPERIORITY_OR_OTHER||CMH adjusted difference|27.0||||0.0075|TWO_SIDED|95.0|7.2|46.8|||Cochran-Mantel-Haenszel|||||46.8|7.2|0.0075
72549945|NCT01249664|144629698|SUPERIORITY_OR_OTHER||CMH adjusted difference|42.7|||<|0.0001|TWO_SIDED|95.0|23.7|61.6|||Cochran-Mantel-Haenszel|||||61.6|23.7|<.0001
72549946|NCT01249664|144629699|SUPERIORITY_OR_OTHER||CMH adjusted difference|-6.5||||0.1478|TWO_SIDED|95.0|-15.2|2.3|||Cochran-Mantel-Haenszel|||||2.3|-15.2|0.1478
72549947|NCT01249664|144629700|SUPERIORITY_OR_OTHER||CMH adjusted difference|-25.8||||0.0006|TWO_SIDED|95.0|-40.6|-11.0|||Cochran-Mantel-Haenszel|||||-11.0|-40.6|0.0006
72549948|NCT01249664|144629701|SUPERIORITY_OR_OTHER||CMH adjusted difference|-32.2|||<|0.0001|TWO_SIDED|95.0|-48.1|-16.3|||Cochran-Mantel-Haenszel|||||-16.3|-48.1|<0.0001
72549949|NCT01249664|144629702|SUPERIORITY_OR_OTHER||CMH adjusted difference|-5.3||||0.2446|TWO_SIDED|95.0|-14.4|3.7|||Cochran-Mantel-Haenszel|||||3.7|-14.4|0.2446
72582951|NCT03918629|144696196|NON_INFERIORITY|The noninferiority objective was achieved if the lower limit of the 95% CI for the difference was \>-10% for both Toxin A and Toxin B.|Percentage difference|-10.3|||||TWO_SIDED|95.0|-15.1|-5.5|||||The difference (2-Dose - 3-Dose) and the associated 95% CIs for the difference were calculated using the Miettinen and Nurminen method.|Toxin B||-5.5|-15.1|
72582952|NCT03832686|144696216|OTHER|||||||0.86||||||A p-value of \<0.05 would be considered statistically significant.|Logistic Regression|||||||0.86
72582953|NCT03832686|144696217|OTHER|||||||0.69||||||A p-value of \<0.05 would be considered statistically significant.|Logistic Regression|||||||0.69
72582954|NCT03832686|144696218|OTHER|||||||0.47||||||A p-value of \<0.05 would be considered statistically significant.|Logistic Regression|||Comparison of Eating in Public Score||||0.47
72582955|NCT03832686|144696218|OTHER|||||||0.73||||||A p-value of \<0.05 would be considered statistically significant.|Logistic Regression|||Comparison of Normalcy of Diet score||||0.73
72582956|NCT03832686|144696219|OTHER|||||||0.65||||||A p-value of \<0.05 would be considered statistically significant.|Logistic Regression|||Comparison of MBSImP Oral score||||0.65
72582957|NCT03832686|144696219|OTHER|||||||0.24||||||A p-value of \<0.05 would be considered statistically significant.|Logistic Regression|||Comparison of MBSImP Pharyngeal score||||0.24
72412775|NCT02731131|144333641|SUPERIORITY_OR_OTHER|||||||0.22|||||||Fisher Exact|||||||0.22
72412776|NCT02731131|144333642|SUPERIORITY_OR_OTHER|||||||0.3|||||||Fisher Exact|||||||0.30
72412777|NCT02731131|144333643|SUPERIORITY_OR_OTHER|||||||0.3|||||||Fisher Exact|||||||0.30
72549950|NCT01249664|144629703|SUPERIORITY_OR_OTHER||CMH adjusted difference|-21.5||||0.0035|TWO_SIDED|95.0|-35.9|-7.0|||Cochran-Mantel-Haenszel|||||-7.0|-35.9|0.0035
72549951|NCT01249664|144629704|SUPERIORITY_OR_OTHER||CMH adjusted difference|-25.7||||0.0012|TWO_SIDED|95.0|-41.3|-10.1|||Cochran-Mantel-Haenszel|||||-10.1|-41.3|0.0012
72549952|NCT01249664|144629705|SUPERIORITY_OR_OTHER||Difference in least square means|-77.9|||<|0.0001|TWO_SIDED|95.0|-108.9|-46.9|||ANCOVA|||||-46.9|-108.9|<0.0001
72549953|NCT01249664|144629706|SUPERIORITY_OR_OTHER||Difference in least square means|-29.3||||0.065|TWO_SIDED|95.0|-60.4|1.8|||ANCOVA|||||1.8|-60.4|0.0650
72549954|NCT01249664|144629707|SUPERIORITY_OR_OTHER||Difference in least square means|-0.4808|||<|0.0001|TWO_SIDED|95.0|-0.599|-0.3626|||ANCOVA|||||-0.3626|-0.5990|<0.0001
72549955|NCT01249664|144629708|SUPERIORITY_OR_OTHER||Difference in least square means|-0.1346||||0.0256|TWO_SIDED|95.0|-0.2525|-0.0167|||ANCOVA|||||-0.0167|-0.2525|0.0256
72549956|NCT01249664|144629709|SUPERIORITY_OR_OTHER||Difference in least square means|-0.0045||||0.869|TWO_SIDED|95.0|-0.0579|0.049|||ANCOVA|||||0.0490|-0.0579|0.8690
72549957|NCT01249664|144629710|SUPERIORITY_OR_OTHER||Difference of least square means|5.21||||0.0104|TWO_SIDED|95.0|1.25|9.18|||ANCOVA|||||9.18|1.25|0.0104
72549958|NCT01249664|144629712|SUPERIORITY_OR_OTHER||Difference in least square means|-0.6648|||<|0.0001|TWO_SIDED|95.0|-0.8056|-0.5239|||ANCOVA|||||-0.5239|-0.8056|<0.0001
72582958|NCT03832686|144696220|OTHER|||||||0.53||||||A p-value of \<0.05 would be considered statistically significant.|Logistic Regression|||||||0.53
72582959|NCT03832686|144696221|OTHER|||||||0.5||||||A p-value of \<0.05 would be considered statistically significant.|Logistic Regression|||||||0.50
72582960|NCT04581824|144696282|OTHER||Difference in Response Rate|9.32|||||TWO_SIDED|80.0|1.46|17.18|||||Mantel and Haenszel method with Sato's variance estimator was used for between arms comparison and was stratified by PD-L1 status and smoking status based on the strata data collected in interactive response technology (IRT) at randomization|||17.18|1.46|
72582961|NCT04796909|144696283|SUPERIORITY|||||||0.05|||||||Repeated-measures ANCOVA|||||||0.05
72582962|NCT04796909|144696284|SUPERIORITY|||||||0.05|||||||Repeated-Measures ANCOVA|||||||0.05
72582963|NCT04796909|144696285|SUPERIORITY|||||||0.05|||||||Repeated-Measures ANCOVA|||||||0.05
72582964|NCT04796909|144696286|SUPERIORITY|||||||0.05|||||||Repeated-Measures ANCOVA|||||||0.05
72582965|NCT04796909|144696287|SUPERIORITY|||||||0.05|||||||Repeated-Measures ANCOVA|||||||0.05
72582966|NCT04796909|144696288|SUPERIORITY|||||||0.05|||||||Repeated-Measures ANCOVA|||||||0.05
72582967|NCT04796909|144696289|SUPERIORITY|||||||0.05|||||||Repeated-Measures ANCOVA|||||||0.05
72582968|NCT04796909|144696290|SUPERIORITY|||||||0.05|||||||t-test, 2 sided|||||||0.05
72412778|NCT02731131|144333644|SUPERIORITY_OR_OTHER|||||||0.5|||||||Fisher Exact|||||||0.50
72582969|NCT04796909|144696291|SUPERIORITY|||||||0.05|||||||t-test, 2 sided|||||||0.05
72582970|NCT04796909|144696292|SUPERIORITY|||||||0.05|||||||Chi-squared|||||||0.05
72582971|NCT04162847|144696328|SUPERIORITY||Odds Ratio (OR)|0.98||||0.76|TWO_SIDED|95.0|0.88|1.1|||Regression, Logistic|||Baseline||1.10|.88|.76
72582972|NCT04162847|144696328|SUPERIORITY||Odds Ratio (OR)|0.84||||0.001|TWO_SIDED|95.0|0.76|0.93|||Regression, Logistic|||6 week follow-up||.93|.76|.001
72582973|NCT04162847|144696328|SUPERIORITY||Odds Ratio (OR)|0.82||||0|TWO_SIDED|95.0|0.74|0.9|||Regression, Logistic|||6 month follow-up||.90|.74|.000
72582974|NCT04162847|144696328|SUPERIORITY||Odds Ratio (OR)|0.86||||0.002|TWO_SIDED|95.0|0.77|0.95|||Regression, Logistic|||2 year||.95|.77|.002
72582975|NCT04162847|144696329|SUPERIORITY||Odds Ratio (OR)|6.7||||0|TWO_SIDED|95.0|5.98|7.5|||Chi-squared|||A comparison of service uptake between the intervention and control groups over the 6-month follow-up period.||7.50|5.98|.000
72582976|NCT04162847|144696329|SUPERIORITY||Odds Ratio (OR)|1.83||||0|TWO_SIDED|95.0|1.64|2.04|||Chi-squared|||A secondary analysis using the same criterion for the intervention group (access to the digital intervention during the 6-month follow-up) but expanding the control group definition to include individuals who reported having psychotherapy or starting a new medication at any point during the full 2-year follow-up period.||2.04|1.64|.000
72582977|NCT04162847|144696330|SUPERIORITY|||||||0|||||||multilevel modeling methods|Multilevel modeling was used to examine differences in changes in each outcome measure between the two conditions.||PHQ-9 6 week||||.000
72582978|NCT04162847|144696330|SUPERIORITY|||||||0|||||||multilevel modeling methods|Multilevel modeling was used to examine differences in changes in each outcome measure between the two conditions.||PHQ-9 6 months||||.000
72582979|NCT04162847|144696330|SUPERIORITY|||||||0.02|||||||multilevel modeling methods|Multilevel modeling was used to examine differences in changes in each outcome measure between the two conditions.||PHQ-9 2 year||||.02
72582980|NCT04162847|144696330|SUPERIORITY|||||||0.002|||||||multilevel modeling methods|Multilevel modeling was used to examine differences in changes in each outcome measure between the two conditions.||GADQ-IV 6 week||||.002
72582981|NCT04162847|144696330|SUPERIORITY|||||||0.8|||||||multilevel modeling methods|Multilevel modeling was used to examine differences in changes in each outcome measure between the two conditions.||GADQ-IV 6 month||||.80
72582982|NCT04162847|144696330|SUPERIORITY|||||||0.51|||||||multilevel modeling methods|Multilevel modeling was used to examine differences in changes in each outcome measure between the two conditions.||GADQ-IV 2 year||||.51
72582983|NCT04162847|144696330|SUPERIORITY|||||||0.004|||||||multilevel modeling methods|Multilevel modeling was used to examine differences in changes in each outcome measure between the two conditions.||SPDQ 6 week||||.004
72582984|NCT04162847|144696330|SUPERIORITY|||||||0.02|||||||multilevel modeling methods|Multilevel modeling was used to examine differences in changes in each outcome measure between the two conditions.||SPDQ 6 month||||.02
72582985|NCT04162847|144696330|SUPERIORITY|||||||0.09|||||||multilevel modeling methods|Multilevel modeling was used to examine differences in changes in each outcome measure between the two conditions.||SPDQ 2 year||||.09
72582986|NCT04162847|144696330|SUPERIORITY|||||||0.66|||||||multilevel modeling methods|Multilevel modeling was used to examine differences in changes in each outcome measure between the two conditions.||PDSR 6 week||||.66
72582987|NCT04162847|144696330|SUPERIORITY|||||||0.85|||||||multilevel modeling methods|Multilevel modeling was used to examine differences in changes in each outcome measure between the two conditions.||PDSR 6 month||||.85
72582988|NCT04162847|144696330|SUPERIORITY|||||||0.97|||||||multilevel modeling methods|Multilevel modeling was used to examine differences in changes in each outcome measure between the two conditions.||PDSR 2 year||||.97
72582989|NCT04162847|144696330|SUPERIORITY|||||||0|||||||multilevel modeling methods|Multilevel modeling was used to examine differences in changes in each outcome measure between the two conditions.||EDE-Q Global 6 week||||.000
72582990|NCT04162847|144696330|SUPERIORITY|||||||0|||||||multilevel modeling methods|Multilevel modeling was used to examine differences in changes in each outcome measure between the two conditions.||EDE-Q Global 6 month||||.000
72582991|NCT04162847|144696330|SUPERIORITY|||||||0.54|||||||multilevel modeling methods|Multilevel modeling was used to examine differences in changes in each outcome measure between the two conditions.||EDE-Q Global 2 year||||.54
72582992|NCT04162847|144696331|SUPERIORITY|||||||0.48|||||||multilevel modeling methods|Multilevel modeling was used to examine differences in changes in each outcome measure between the two conditions.||Mental component summary 6 months||||.48
72582993|NCT04162847|144696331|SUPERIORITY|||||||0.04|||||||multilevel modeling methods|Multilevel modeling was used to examine differences in changes in each outcome measure between the two conditions.||Mental component summary 2 years||||.04
72412779|NCT01055639|144333673|SUPERIORITY_OR_OTHER|||||||0.12|||||||t-test, 2 sided|||||||0.12
72412780|NCT01055639|144333674|SUPERIORITY_OR_OTHER|||||||0.04|||||||t-test, 2 sided|||||||0.04
72412781|NCT01055639|144333675|SUPERIORITY_OR_OTHER|||||||0.88|||||||t-test, 2 sided|||||||0.88
72412782|NCT01055639|144333676|SUPERIORITY_OR_OTHER|||||||0.48|||||||t-test, 2 sided|||||||0.48
72412783|NCT01055639|144333677|SUPERIORITY_OR_OTHER|||||||0.87|||||||t-test, 2 sided|||||||0.87
72412784|NCT01055639|144333678|SUPERIORITY_OR_OTHER|||||||0.29|||||||t-test, 2 sided|||||||0.29
72412785|NCT01055639|144333679|SUPERIORITY_OR_OTHER|||||||0.19|||||||t-test, 2 sided|||||||0.19
72412786|NCT01055639|144333680|SUPERIORITY_OR_OTHER|||||||0.53|||||||t-test, 2 sided|||||||0.53
72412787|NCT01055639|144333681|SUPERIORITY_OR_OTHER|||||||1|||||||t-test, 2 sided|||||||1.00
72412788|NCT00562159|144333682|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.31|||=|0.005|TWO_SIDED|95.0|-2.22|-0.4|||ANOVA|Asthma status, treatment group, and site were fixed effects.||||-0.40|-2.22|=0.005
72549959|NCT00023309|144629725|SUPERIORITY_OR_OTHER|||||||0.0294||95.0|||||Fisher Exact|||Null hypothesis: there is no difference in the treatment effect between the two groups||||0.0294
72549960|NCT00023309|144629726|SUPERIORITY_OR_OTHER|||||||0.0325||95.0|||||Fisher Exact|||Null hypothesis: there is no difference in treatment effect at week 196||||0.0325
72549961|NCT00023309|144629727|SUPERIORITY_OR_OTHER|||||||0.0049||95.0|||||Fisher Exact|||Null hypothesis: there is no difference in treatment effect at week 196||||0.0049
72549962|NCT00023309|144629728|SUPERIORITY_OR_OTHER|||||||0.0157||95.0|||||Fisher Exact|||Null hypothesis: there is no difference in treatment effect at week 196||||0.0157
72582994|NCT04162847|144696331|SUPERIORITY|||||||0.97|||||||multilevel modeling methods|Multilevel modeling was used to examine differences in changes in each outcome measure between the two conditions.||Physical component summary 6 months||||.97
72582995|NCT04162847|144696331|SUPERIORITY|||||||0.8|||||||multilevel modeling methods|Multilevel modeling was used to examine differences in changes in each outcome measure between the two conditions.||Physical component summary 2 years||||.80
72582996|NCT00813150|144696338|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.71||||0.196|TWO_SIDED|95.0|0.43|1.19|||Regression, Cox|||Null Hypothesis: The (median) time to progression is equal in both treatment groups||1.19|0.43|0.196
72582997|NCT00813150|144696339|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.71||||0.196|TWO_SIDED|95.0|0.43|1.19|||Regression, Cox|||||1.19|0.43|0.196
72412789|NCT00562159|144333683|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.86|||=|0.015|TWO_SIDED|95.0|-1.46|-0.26|||ANOVA|Asthma status, treatment group, and site were fixed effects.||||-0.26|-1.46|=0.015
72412790|NCT00562159|144333684|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.45|||=|0.084|TWO_SIDED|95.0|-0.96|0.06|||ANOVA|Asthma status, treatment group, and site were fixed effects.||||0.06|-0.96|=0.084
72412791|NCT00562159|144333685|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.27|||=|0.022|TWO_SIDED|95.0|-0.48|-0.05|||ANOVA|Asthma status, treatment group, and site were fixed effects.||||-0.05|-0.48|=0.022
72412792|NCT02417246|144333693|EQUIVALENCE|A paired t-test was used to compare mean values of AUC0-24 for brand name metoprolol ER and Generic B at the 50mg dose. With a sample size of 38, at an alpha level of 0.025 (0.05/2 comparisons), using a 2-sided paired t test, we would have \>80% power to detect a 16% difference in AUC.|Mean Difference (Final Values)|45.1|STANDARD_DEVIATION|222.2||0.3|TWO_SIDED|95.0|-41.1|131.2|||t-test, 2 sided|Average AUC from 0 to 24 hours (0-24) for patients on the 50mg dose of brand name metoprolol ER and Generic B were compared by a paired t-test (n=28)||||131.2|-41.1|0.3
72412793|NCT02417246|144333693|EQUIVALENCE|A bioequivalence (BE) test was performed for patients who were administered the 50mg dose. BE was declared if 90% confidence interval for the ratio of the population geometric means of the AUC0-24 for Generic B to brand name metoprolol ER falls within 0.8 to 1.25|Geometric mean ratio|0.85|||||TWO_SIDED|90.0|0.76|0.95||The analysis included a total of 20 patients on Generic B and brand name metoprolol ER, which is less than the initial plan of including 38 patients.||||||0.95|0.76|
72412794|NCT02417246|144333693|EQUIVALENCE|A paired t-test was used to compare mean values of AUC0-24 for brand name metoprolol ER and Generic A at the 50mg dose. With a sample size of 38, at an alpha level of 0.025 (0.05/2 comparisons), using a 2-sided paired t test, we would have \>80% power to detect a 16% difference in AUC.|Mean Difference (Final Values)|7.2|STANDARD_DEVIATION|176.5||0.8|TWO_SIDED|95.0|-60.0|74.3|||t-test, 2 sided|Average AUC0-24 for patients on the 50mg dose who were administered brand name metoprolol ER and Generic A were compared using a paired t-test (n=29)||||74.3|-60.0|0.8
72412795|NCT02417246|144333693|EQUIVALENCE|A bioequivalence (BE) test was performed for patients who were administered the 50mg dose. BE was declared if the 90% confidence interval for the ratio of the population geometric means of the AUC0-24 for Generic A to brand name metoprolol ER fell within 0.8 to 1.25|Geometric mean ratio|0.93|||||TWO_SIDED|90.0|0.86|1.01||This analysis included 21 individuals who were administered brand name metoprolol ER and Generic A, which is less than the initial plan of including 38 patients.||||||1.01|0.86|
72412796|NCT02417246|144333694|EQUIVALENCE|A paired t-test was used to compare the mean values of Cmax for brand name metoprolol ER and Generic B at the 50mg dose. With a sample size of 38, at an alpha level of 0.025 (0.05/2 comparisons), using a 2-sided paired t-test, we would have \>80% power to detect a 11% difference in Cmax.|Mean Difference (Final Values)|2.6|STANDARD_DEVIATION|10.7||0.2|TWO_SIDED|95.0|-1.5|6.6|||t-test, 2 sided|Average Cmax for patients on the 50mg dose who were administered brand name metoprolol ER and Generic B were compared using a paired t-test (n=29)||||6.6|-1.5|0.2
72412797|NCT02417246|144333694|EQUIVALENCE|A bioequivalence (BE) test was performed for patients who were administered the 50mg dose. BE was declared if the 90% confidence interval for the ratio of the population geometric means of Cmax for Generic B to brand name metoprolol ER fell within 0.8 to 1.25|Geometric mean ratio|0.87|||||TWO_SIDED|90.0|0.79|0.95||The analysis included a total of 29 patients on Generic B and brand name metoprolol ER, which is less than the initial plan of including 38 patients||||||0.95|0.79|
72549963|NCT00023309|144629729|SUPERIORITY_OR_OTHER|||||||0.0913||95.0|||||Fisher Exact|||Null hypothesis: there is no difference in treatment effect at week 196||||0.0913
72549964|NCT03247556|144629730|SUPERIORITY||Least Square Mean Difference|-5.1|STANDARD_ERROR_OF_MEAN|1.93||0.0082|TWO_SIDED|95.0|-8.9|-1.3|||Mixed Model for Repeated Measures|||||-1.3|-8.9|0.0082
72549965|NCT03247556|144629730|SUPERIORITY||Least Square Mean Difference|-3.5|STANDARD_ERROR_OF_MEAN|1.93||0.0712|TWO_SIDED|95.0|-7.3|0.3|||Mixed Model for Repeated Measures|||||0.3|-7.3|0.0712
72549966|NCT03247556|144629731|SUPERIORITY||Least Square Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.17||0.0051|TWO_SIDED|95.0|-0.8|-0.1|||ANCOVA|ANCOVA model with baseline Clinical Global Impression-Severity of Illness (CGI-S) score and treatment as fixed independent variables.||||-0.1|-0.8|0.0051
72582998|NCT00813150|144696340|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.85||||0.645|TWO_SIDED|95.0|0.41|1.73|||Regression, Cox|||||1.73|0.41|0.645
72582999|NCT00813150|144696341|SUPERIORITY_OR_OTHER|||||||0.814|||||||Fisher Exact|||||||0.814
72583000|NCT03664232|144696356|SUPERIORITY||Least-Squares Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.09|=|0.284|TWO_SIDED|80.0|-0.17|0.07|||Mixed effects model for repeatedmeasures|||||0.07|-0.17|=0.284
72583001|NCT03664232|144696357|SUPERIORITY||Least-Squares Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.1|=|0.29|TWO_SIDED|80.0|-0.18|0.07|||MMRM|||||0.07|-0.18|=0.290
72583002|NCT03664232|144696358|SUPERIORITY||Least-Squares Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.1|=|0.231|TWO_SIDED|80.0|-0.21|0.06|||MMRM|||||0.06|-0.21|=0.231
72583003|NCT00460603|144696438|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.585||||0.9726|TWO_SIDED|95.0|0.332|1.031|||Cochran-Mantel-Haenszel|||One-sided Cochran-Mantel-Haenszel test of treatment stratified by prior adjuvant chemotherapy (yes versus \[vs.\] no) and prior pelvic irradiation (yes vs. no) was used for the analysis.||1.031|0.332|0.9726
72583004|NCT00460603|144696438|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.735||||0.8391|TWO_SIDED|95.0|0.399|1.352|||Cochran-Mantel-Haenszel|||One-sided Cochran-Mantel-Haenszel test of treatment stratified by prior adjuvant chemotherapy (yes vs. no) and prior pelvic irradiation (yes vs. no) was used for the analysis.||1.352|0.399|0.8391
72583005|NCT00460603|144696438|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.797||||0.8192|TWO_SIDED|95.0|0.489|1.299|||Cochran-Mantel-Haenszel|||One-sided Cochran-Mantel-Haenszel test of treatment stratified by prior adjuvant chemotherapy (yes vs. no) and prior pelvic irradiation (yes vs. no) was used for the analysis.||1.299|0.489|0.8192
72583006|NCT00460603|144696470|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.08||||0.5699|TWO_SIDED|95.0|0.47|2.45|||Log Rank|||Hazard ratio and corresponding 95% confidence interval (CI) was calculated based on the Cox proportional hazards model stratified by prior adjuvant chemotherapy (yes vs. no) and prior pelvic irradiation (yes vs. no). One-sided p-value was derived from the log-rank test stratified by prior adjuvant chemotherapy (yes vs. no) and prior pelvic irradiation (yes vs. no).||2.45|0.47|0.5699
72583007|NCT00460603|144696470|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.73||||0.2167|TWO_SIDED|95.0|0.33|1.61|||Log Rank|||Hazard ratio and corresponding 95% CI was calculated based on the Cox proportional hazards model stratified by prior adjuvant chemotherapy (yes vs. no) and prior pelvic irradiation (yes vs. no). One-sided p-value was derived from the log-rank test stratified by prior adjuvant chemotherapy (yes vs. no) and prior pelvic irradiation (yes vs. no).||1.61|0.33|0.2167
72583008|NCT00460603|144696470|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.49||||0.8746|TWO_SIDED|95.0|0.75|2.98|||Log Rank|||Hazard ratio and corresponding 95% CI was calculated based on the Cox proportional hazards model stratified by prior adjuvant chemotherapy (yes vs. no) and prior pelvic irradiation (yes vs. no). One-sided p-value was derived from the log-rank test stratified by prior adjuvant chemotherapy (yes vs. no) and prior pelvic irradiation (yes vs. no).||2.98|0.75|0.8746
72412798|NCT02417246|144333694|EQUIVALENCE|A paired t-test was used to compare the mean values of Cmax for brand name metoprolol ER and Generic A at the 50mg dose. With a sample size of 38, at an alpha level of 0.025 (0.05/2 comparisons), using a 2-sided paired t-test, we would have \>80% power to detect a 11% difference in Cmax.|Mean Difference (Final Values)|-2.5|STANDARD_DEVIATION|12.6||0.3|TWO_SIDED|95.0|-7.3|2.3|||t-test, 2 sided|Average Cmax for patients on the 50mg dose who were administered brand name metoprolol ER and Generic A were compared using a paired t-test (n=29)||||2.3|-7.3|0.3
72583009|NCT00460603|144696471|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.4||||0.8884|TWO_SIDED|95.0|0.81|2.41|||Log Rank|||Hazard ratio and corresponding 95% CI was calculated based on the Cox proportional hazards model stratified by prior adjuvant chemotherapy (yes vs. no) and prior pelvic irradiation (yes vs. no). One-sided p-value was derived from the log-rank test stratified by prior adjuvant chemotherapy (yes vs. no) and prior pelvic irradiation (yes vs. no).||2.41|0.81|0.8884
72583010|NCT00460603|144696471|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.12||||0.6648|TWO_SIDED|95.0|0.66|1.89|||Log Rank|||Hazard ratio and corresponding 95% CI was calculated based on the Cox proportional hazards model stratified by prior adjuvant chemotherapy (yes vs. no) and prior pelvic irradiation (yes vs. no). One-sided p-value was derived from the log-rank test stratified by prior adjuvant chemotherapy (yes vs. no) and prior pelvic irradiation (yes vs. no).||1.89|0.66|0.6648
72583011|NCT00460603|144696471|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.25||||0.8065|TWO_SIDED|95.0|0.75|2.07|||Log Rank|||Hazard ratio and corresponding 95% CI was calculated based on the Cox proportional hazards model stratified by prior adjuvant chemotherapy (yes vs. no) and prior pelvic irradiation (yes vs. no). One-sided p-value was derived from the log-rank test stratified by prior adjuvant chemotherapy (yes vs. no) and prior pelvic irradiation (yes vs. no).||2.07|0.75|0.8065
72583012|NCT00460603|144696472|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.155||||0.6904|TWO_SIDED|95.0|0.656|2.033|||Log Rank|||Hazard ratio and corresponding 95% CI was calculated based on the Cox proportional hazards model stratified by prior adjuvant chemotherapy (yes vs. no) and prior pelvic irradiation (yes vs. no). One-sided p-value was derived from the log-rank test stratified by prior adjuvant chemotherapy (yes vs. no) and prior pelvic irradiation (yes vs. no).||2.033|0.656|0.6904
72583013|NCT00460603|144696472|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.203||||0.7364|TWO_SIDED|95.0|0.676|2.141|||Log Rank|||Hazard ratio and corresponding 95% CI was calculated based on the Cox proportional hazards model stratified by prior adjuvant chemotherapy (yes vs. no) and prior pelvic irradiation (yes vs. no). One-sided p-value was derived from the log-rank test stratified by prior adjuvant chemotherapy (yes vs. no) and prior pelvic irradiation (yes vs. no).||2.141|0.676|0.7364
72583014|NCT00460603|144696472|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.941||||0.414|TWO_SIDED|95.0|0.535|1.653|||Log Rank|||Hazard ratio and corresponding 95% CI was calculated based on the Cox proportional hazards model stratified by prior adjuvant chemotherapy (yes vs. no) and prior pelvic irradiation (yes vs. no). One-sided p-value was derived from the log-rank test stratified by prior adjuvant chemotherapy (yes vs. no) and prior pelvic irradiation (yes vs. no).||1.653|0.535|0.4140
72583015|NCT00289848|144696487|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.03|STANDARD_DEVIATION|1.08|<|0.001||95.0|-1.23|-0.83|||ANCOVA|ANCOVA with terms of treatment, country, prior diabetes pharmacotherapy (not on AHA or on AHA), and baseline A1C as a covariate||||-0.83|-1.23|<0.001
72583016|NCT00289848|144696488|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-31.0|STANDARD_DEVIATION|39.8|<|0.001||95.0|-38.4|-23.7|||ANCOVA|ANCOVA with terms of treatment, country, prior diabetes pharmacotherapy (not on AHA or on AHA), and baseline FPG as a covariate||||-23.7|-38.4|<0.001
72412799|NCT02417246|144333694|EQUIVALENCE|A bioequivalence (BE) test was performed for patients who were administered the 50mg dose. BE was declared if the 90% confidence interval for the ratio of the population geometric means of Cmax for Generic A to brand name metoprolol ER fell within 0.8 to 1.25|Geometric mean ratio|1.12|||||TWO_SIDED|90.0|1.02|1.23||The analysis included a total of 29 patients on Generic A and brand name metoprolol ER, which is less than a pre-planned sample size of 38.||||||1.23|1.02|
72583017|NCT00289848|144696489|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-56.6|STANDARD_DEVIATION|59.2|<|0.001||95.0|-68.8|-44.3|||ANCOVA|ANCOVA with terms of treatment, country, prior diabetes pharmacotherapy (not on AHA or on AHA), and baseline 2-hr PMG as a covariate||||-44.3|-68.8|<0.001
72583018|NCT00860795|144696490|SUPERIORITY_OR_OTHER|||||||0.17|TWO_SIDED|95.0|||||Regression, Linear|||||||.17
72583019|NCT00860795|144696491|SUPERIORITY_OR_OTHER|||||||0.72|TWO_SIDED|95.0|||||Regression, Linear|||||||.72
72583020|NCT00860795|144696492|SUPERIORITY_OR_OTHER|||||||0.2|TWO_SIDED|95.0|||||Regression, Linear|||||||.2
72583021|NCT00860795|144696494|SUPERIORITY_OR_OTHER|||||||0.51|TWO_SIDED|95.0|||||Regression, Linear|||||||.51
72583022|NCT00860795|144696495|SUPERIORITY_OR_OTHER|||||||0.43|TWO_SIDED|95.0|||||Regression, Linear|||||||.43
72583023|NCT00860795|144696496|SUPERIORITY_OR_OTHER|||||||0.61|TWO_SIDED|95.0|||||Regression, Linear|||||||.61
72583024|NCT03871543|144696497|OTHER|Statistical Difference|Mean difference|0.159|STANDARD_ERROR_OF_MEAN|0.287|||ONE_SIDED|95.0|-0.402||||Mixed Models Analysis|The Kenward and Roger Method was used for the denominator degrees of freedom.|Mean difference was calculated as Symptomatic minus Asymptomatic|Upper Lid|||-0.402|
72583025|NCT03871543|144696497|OTHER|Statistical Difference|Mean Difference|0.236|STANDARD_ERROR_OF_MEAN|0.289|||ONE_SIDED|95.0|-0.328||||Mixed Models Analysis|The Kenward and Roger Method was used for the denominator degrees of freedom.|Mean difference was calculated as Symptomatic minus Asymptomatic|Lower Lid|||-0.328|
72583026|NCT03871543|144696498|OTHER|Statistical difference|Mean Ratio|0.918|||||ONE_SIDED|95.0||1.227|||Generalized Linear Mixed Model|The Kenward and Roger Method was used for the denominator degrees of freedom.|Mean ratio was calculated as Symptomatic divided by Asymptomatic|||1.227||
72583027|NCT03871543|144696499|OTHER|Statistical difference|Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.019|||ONE_SIDED|95.0||0.022|||Mixed Models Analysis|The Kenward and Roger Method was used for the denominator degrees of freedom.|Mean difference was calculated as Symptomatic minus Asymptomatic|||0.022||
72583028|NCT03871543|144696500|OTHER|Statistical difference|Mean Difference|1.185|STANDARD_ERROR_OF_MEAN|3.483|||ONE_SIDED|95.0|-4.613||||Mixed Models Analysis|The Kenward and Roger Method was used for the denominator degrees of freedom.|Mean difference was calculated as Symptomatic minus Asymptomatic||||-4.613|
72583029|NCT03871543|144696501|OTHER|Statistical difference|Mean Ratio|1.984|||||ONE_SIDED|95.0|1.198||||Generalized Linear Mixed Model|The Kenward and Roger Method was used for the denominator degrees of freedom.|Mean Ratio was calculated as Symptomatic divided by Asymptomatic|Upper Lid|||1.198|
72583030|NCT03871543|144696501|OTHER|Statistical Difference|Mean Ratio|1.8|||||ONE_SIDED|95.0|1.093||||Generalized Linear Mixed Model|The Kenward and Roger Method was used for the denominator degrees of freedom.|Mean Ratio was calculated as Symptomatic divided by Asymptomatic|Lower Lid|||1.093|
72583031|NCT03871543|144696502|OTHER|Statistical significance correlation: Statistically Significant correlations were concluded if the upper CL is below 0 or the lower CL is above 0|Correlation Coefficient|-0.1416||||0.3446|TWO_SIDED|95.0|-0.4148|0.1551|||Pearson correlation|Pearson correlation statistics using Fisher's z transformation||||0.1551|-0.4148|0.3446
72583032|NCT03871543|144696503|OTHER|Statistical significance correlation: Statistically Significant correlations were concluded if the upper CL is below 0 or the lower CL is above 0|Correlation Coefficient|0.0887||||0.5556|TWO_SIDED|95.0|-0.207|0.3694|||Pearson correlation|Pearson correlation statistics using Fisher's z transformation||||0.3694|-0.2070|0.5556
72583033|NCT03871543|144696504|OTHER|Statistical significance correlation: Statistically Significant correlations were concluded if the upper CL is below 0 or the lower CL is above 0|Correlation Coefficient|-0.2052||||0.1676|TWO_SIDED|95.0|-0.4676|0.0905|||Pearson correlation|Pearson correlation statistics using Fisher's z transformation||||0.0905|-0.4676|0.1676
72583034|NCT03871543|144696505|OTHER|Statistical significance correlation: Statistically Significant correlations were concluded if the upper CL is below 0 or the lower CL is above 0|Correlation Coefficient|0.0903||||0.5483|TWO_SIDED|95.0|-0.2054|0.3709|||Pearson correlation|Pearson correlation statistics using Fisher's z transformation||||0.3709|-0.2054|0.5483
72583035|NCT03871543|144696506|OTHER|Statistical significance correlation: Statistically Significant correlations were concluded if the upper CL is below 0 or the lower CL is above 0|Correlation Coefficient|-0.2679||||0.0719|TWO_SIDED|95.0|-0.5205|0.0278|||Pearson correlation|Pearson correlation statistics using Fisher's z transformation||||0.0278|-0.5205|0.0719
72583036|NCT03871543|144696507|OTHER|Statistical significance correlation: Statistically Significant correlations were concluded if the upper CL is below 0 or the lower CL is above 0|Correlation Coefficient|-0.3434||||0.019|TWO_SIDED|95.0|-0.5786|0.0554|||Pearson correlation|Pearson correlation statistics using Fisher's z transformation||||0.0554|-0.5786|0.0190
72583037|NCT03871543|144696508|OTHER|Statistical significance correlation: Statistically Significant correlations were concluded if the upper CL is below 0 or the lower CL is above 0|Correlation Coefficient|-0.2975||||0.042|TWO_SIDED|95.0|-0.541|-0.0078|||Pearson correlation|Pearson correlation statistics using Fisher's z transformation||||-0.0078|-0.5410|0.0420
72549967|NCT03247556|144629731|SUPERIORITY||Least Square Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.17||0.0995|TWO_SIDED|95.0|-0.6|0.1|||ANCOVA|ANCOVA model with baseline Clinical Global Impression-Severity of Illness (CGI-S) score and treatment as fixed independent variables.||||0.1|-0.6|0.0995
72549968|NCT03247556|144629732|SUPERIORITY||Least Square Mean Difference|-1.9|STANDARD_ERROR_OF_MEAN|1.26||0.1377|TWO_SIDED|95.0|-4.3|0.6|||ANCOVA|||||0.6|-4.3|0.1377
72549969|NCT03247556|144629732|SUPERIORITY||Least Square Mean Difference|-1.3|STANDARD_ERROR_OF_MEAN|1.25||0.313|TWO_SIDED|95.0|-3.7|1.2|||ANCOVA|||||1.2|-3.7|0.3130
72549970|NCT03247556|144629733|SUPERIORITY||Least Square Mean Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.049||0.0698|TWO_SIDED|95.0|-0.19|0.01|||ANCOVA|||||0.01|-0.19|0.0698
72549971|NCT03247556|144629733|SUPERIORITY||Least Square Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.05||0.9756|TWO_SIDED|95.0|-0.1|0.1|||ANCOVA|||||0.10|-0.10|0.9756
72549972|NCT03247556|144629734|SUPERIORITY||Risk Difference (RD)|15.3||||0.0349|TWO_SIDED|95.0|1.3|29.3|||Regression, Logistic|||||29.3|1.3|0.0349
72583038|NCT03871543|144696509|OTHER|Statistical significance correlation: Statistically Significant correlations were concluded if the upper CL is below 0 or the lower CL is above 0|Correlation Coefficient|0.127||||0.3973|TWO_SIDED|95.0|-0.1696|0.4024|||Pearson correlation|Pearson correlation statistics using Fisher's z transformation||||0.4024|-0.1696|0.3973
72583039|NCT03871543|144696510|OTHER|Statistical significance correlation: Statistically Significant correlations were concluded if the upper CL is below 0 or the lower CL is above 0|Correlation Coefficient|-0.021||||0.8894|TWO_SIDED|95.0|-0.3094|0.271|||Pearson correlation|Pearson correlation statistics using Fisher's z transformation||||0.2710|-0.3094|0.8894
72583040|NCT03871543|144696511|OTHER|Statistical significance correlation: Statistically Significant correlations were concluded if the upper CL is below 0 or the lower CL is above 0|Correlation Coefficient|0.0762||||0.6129|TWO_SIDED|95.0|-0.219|0.3585|||Pearson correlation|Pearson correlation statistics using Fisher's z transformation||||0.3585|-0.2190|0.6129
72583041|NCT03871543|144696512|OTHER|Statistical significance correlation: Statistically Significant correlations were concluded if the upper CL is below 0 or the lower CL is above 0|Correlation Coefficient|-0.1402||||0.3493|TWO_SIDED|95.0|-0.4137|0.1565|||Pearson correlation|Pearson correlation statistics using Fisher's z transformation||||0.1565|-0.4137|0.3493
72583042|NCT03871543|144696513|OTHER|Statistical significance correlation: Statistically Significant correlations were concluded if the upper CL is below 0 or the lower CL is above 0|Correlation Coefficient|-0.1192||||0.427|TWO_SIDED|95.0|-0.3958|0.1772|||Pearson correlation|Pearson correlation statistics using Fisher's z transformation||||0.1772|-0.3958|0.4270
72583043|NCT02069015|144696534|SUPERIORITY||Mean Difference|0.05|||<|0.001|TWO_SIDED|95.0|-4.781|6.906|||paired t-test|||||6.906|-4.781|<0.001
72583044|NCT03051100|144696541|SUPERIORITY||Least squares mean difference|-60.5|STANDARD_ERROR_OF_MEAN|3.67|<|0.001|TWO_SIDED|95.0|-68.0|-53.0|||ANCOVA||Triplet therapy minus placebo|||-53.0|-68.0|<0.001
72583045|NCT03051100|144696542|SUPERIORITY||Least squares mean difference|-58.7|STANDARD_ERROR_OF_MEAN|3.02|<|0.001|TWO_SIDED|95.0|-64.9|-52.6|||ANCOVA||Triplet therapy minus placebo|non-HDL-C||-52.6|-64.9|<0.001
72583046|NCT03051100|144696542|SUPERIORITY||Least squares mean difference|-46.0|STANDARD_ERROR_OF_MEAN|2.77|<|0.001|TWO_SIDED|95.0|-51.6|-40.4|||ANCOVA||Triplet therapy minus placebo|TC||-40.4|-51.6|<0.001
72583047|NCT03051100|144696542|SUPERIORITY||Least squares mean difference|-54.1|STANDARD_ERROR_OF_MEAN|2.74|<|0.001|TWO_SIDED|95.0|-59.7|-48.6|||ANCOVA|||apoB||-48.6|-59.7|<0.001
72583048|NCT03051100|144696542|SUPERIORITY||Least squares mean difference|-36.3|STANDARD_ERROR_OF_MEAN|6.58|<|0.001|TWO_SIDED|95.0|-49.7|-22.8|||ANCOVA|||TG||-22.8|-49.7|<0.001
72583049|NCT03051100|144696542|SUPERIORITY||Least squares mean difference|-1.5|STANDARD_ERROR_OF_MEAN|2.7|=|0.588|TWO_SIDED|95.0|-7.0|4.0|||ANCOVA|||HDL-C||4.0|-7.0|=0.588
72549973|NCT03247556|144629734|SUPERIORITY||Risk Difference (RD)|13.1||||0.0698|TWO_SIDED|95.0|-0.9|27.0|||Regression, Logistic|||||27.0|-0.9|0.0698
72549974|NCT03247556|144629735|SUPERIORITY||Least Square Mean Difference|-7.3|STANDARD_ERROR_OF_MEAN|4.76||0.1259|TWO_SIDED|95.0|-16.6|2.0|||ANCOVA|||||2.0|-16.6|0.1259
72549975|NCT03247556|144629735|SUPERIORITY||Least Square Mean Difference|1.6|STANDARD_ERROR_OF_MEAN|4.78||0.7417|TWO_SIDED|95.0|-7.8|10.9|||ANCOVA|||||10.9|-7.8|0.7417
72549976|NCT03247556|144629736|SUPERIORITY||Least Square Mean Difference|-1.9|STANDARD_ERROR_OF_MEAN|0.97||0.0484|TWO_SIDED|95.0|-3.8|0.0|||ANCOVA|||This analysis pertains to the Hyperactivity/Impulsivity subscale score||-0.0|-3.8|0.0484
72549977|NCT03247556|144629736|SUPERIORITY||Least Square Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|0.96||0.2084|TWO_SIDED|95.0|-3.1|0.7|||ANCOVA|||This analysis pertains to the Hyperactivity/Impulsivity subscale score||0.7|-3.1|0.2084
72549978|NCT03247556|144629736|SUPERIORITY||Least Square Mean Difference|-3.0|STANDARD_ERROR_OF_MEAN|1.06||0.0042|TWO_SIDED|95.0|-5.1|-1.0|||ANCOVA|||This analysis pertains to the Inattention subscale score||-1.0|-5.1|0.0042
72549979|NCT03247556|144629736|SUPERIORITY||Least Square Mean Difference|-1.6|STANDARD_ERROR_OF_MEAN|1.06||0.1392|TWO_SIDED|95.0|-3.6|0.5|||ANCOVA|||This analysis pertains to the Inattention subscale score||0.5|-3.6|0.1392
72549980|NCT03247556|144629737|SUPERIORITY||Least Square Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|1.07||0.381|TWO_SIDED|95.0|-3.0|1.2|||ANCOVA|||||1.2|-3.0|0.3810
72549981|NCT03247556|144629737|SUPERIORITY||Least Square Mean Difference|-2.2|STANDARD_ERROR_OF_MEAN|1.08||0.0432|TWO_SIDED|95.0|-4.3|-0.1|||ANCOVA|||||-0.1|-4.3|0.0432
72549982|NCT03247556|144629738|SUPERIORITY|||||||0.1433|||||||Chi-squared|||This analysis pertains to Week 1||||0.1433
72549983|NCT03247556|144629738|SUPERIORITY|||||||0.0114|||||||Chi-squared|||This analysis pertains to Week 2||||0.0114
72549984|NCT03247556|144629738|SUPERIORITY|||||||0.0008|||||||Chi-squared|||This analysis pertains to Week 3||||0.0008
72549985|NCT03247556|144629738|SUPERIORITY|||||||0.0197|||||||Chi-squared|||This analysis pertains to Week 4||||0.0197
72549986|NCT03247556|144629738|SUPERIORITY|||||||0.0573|||||||Chi-squared|||This analysis pertains to Week 5||||0.0573
72549987|NCT03247556|144629738|SUPERIORITY|||||||0.0105|||||||Chi-squared|||This analysis pertains to Week 6||||0.0105
72549988|NCT03247556|144629738|SUPERIORITY|||||||0.0004|||||||Chi-squared|||This analysis pertains to Week 7||||0.0004
72549989|NCT03247556|144629738|SUPERIORITY|||||||0.2573|||||||Chi-squared|||This analysis pertains to Week 1||||0.2573
72583050|NCT03051100|144696543|SUPERIORITY||Median treatment difference|-41.9|STANDARD_ERROR_OF_MEAN|9.86|<|0.001|TWO_SIDED|95.0|-60.0|-21.4|||Wilcoxon rank sum test|||||-21.4|-60.0|<0.001
72583051|NCT03051100|144696544|SUPERIORITY||||||<|0.001|TWO_SIDED||||||Fisher Exact|||||||<0.001
72583052|NCT03051100|144696545|SUPERIORITY||||||<|0.001|TWO_SIDED||||||Fisher Exact|||||||<0.001
72583053|NCT01169064|144696554|SUPERIORITY_OR_OTHER|||||||0.365|||||||Chi-squared|||||||.365
72583054|NCT01169064|144696555|SUPERIORITY|||||||0.282|||||||Mixed Models Analysis|||||||.282
72583055|NCT00789854|144696587|NON_INFERIORITY_OR_EQUIVALENCE|"The non-inferiority margin for differences was set to 3 units in the MADRS total score.~A power set to 80% and using a Bonferroni-adjusted one-sided alpha\* = alpha/3 = 0.0083 yields a planned sample size of 192 patients per study group. With a drop out of 4% a total of 600 randomized patients were required to obtain 192 efficacy evaluable patients per treatment group."|Mean Difference (Final Values)|-2.322||||||97.5|-4.6|-0.05||The CI is for comparing add-on quetiapine versus add-on Lithium. The CI = confidence interval was adjusted for multiple comparisons. The -0.05 value should have been +3 or above to fail to reject the null hypothesis.|ANCOVA|Non-inferiority between add-on quetiapine XR and add-on lithium was shown in the Per Protocol analysis set.||Add-on quetiapine XR was tested versus add-on lithium for non-inferiority. The null hypothesis was that the add-on quetiapine treatment was non-inferior to add-on lithium.||-0.05|-4.6|
72583056|NCT00789854|144696587|NON_INFERIORITY_OR_EQUIVALENCE|"The non-inferiority margin for differences was set to 3 units in the MADRS total score.~A power set to 80% and using a Bonferroni-adjusted one-sided alpha\* = alpha/3 = 0.0083 yields a planned sample size of 192 patients per study group. With a drop out of 4% a total of 600 randomized patients were required to obtain 192 efficacy evaluable patients per treatment group."|Mean Difference (Final Values)|-1.639||||||97.5|-3.24|1.312||The CI is for comparing quetiapine XR mono versus add-on Lithium. The CI = confidence interval was adjusted for multiple comparisons. The 1.312 value should have been +3 or above to fail to reject the null hypothesis.|ANCOVA|Non-inferiority between quetiapine XR mono and add-on lithium was shown in the Per Protocol analysis set.||Quetiapine XR mono was tested versus add-on lithium for non-inferiority. The null hypothesis was that the quetiapine XR mono treatment was non-inferior to add-on lithium.||1.312|-3.24|
72583057|NCT00789854|144696588|SUPERIORITY_OR_OTHER|||||||0.0489||95.0||||Adjustment for multiplicity was done, alpha = 0.025|ANCOVA|Superiority testing of primary outcome showed no significant difference in the Modified Intention To Treat (ITT) population||The null hypothesis was that the add-on quetiapine XR treatment was not different to the add-on lithium treatment. The power calculation was done for the primary non-inferior analysis. This superiority analysis was only done if the non-inferior analysis was successful.||||0.0489
72583058|NCT00789854|144696588|SUPERIORITY_OR_OTHER|||||||0.4368||95.0||||Adjustment for multiplicity was done, alpha = 0.025|ANCOVA|Superiority testing of primary outcome showed no significant difference in the Modified Intention To Treat (ITT) population||The null hypothesis was that the quetiapine XR mono treatment was not different from the add-on lithium treatment. The power calculation was done for the primary non-inferior analysis. This superiority analysis was only done if the non-inferior analysis was successful.||||0.4368
72583059|NCT01416636|144696620|SUPERIORITY|||||||0.002|||||||ANCOVA|||||||0.002
72412800|NCT02417246|144333695|EQUIVALENCE|A mixed effect model for repeated measures was used to model medication effect on HRV comparing brand name metoprolol ER to Generic B, adjusting for quartile, (quartile\*med) interaction, and treatment assignment.|Slope|-0.7|STANDARD_ERROR_OF_MEAN|0.3||0.0858|TWO_SIDED||||||Mixed Models Analysis|||||||0.0858
72549990|NCT03247556|144629738|SUPERIORITY|||||||0.165|||||||Chi-squared|||This analysis pertains to Week 2||||0.1650
72549991|NCT03247556|144629738|SUPERIORITY|||||||0.0372|||||||Chi-squared|||This analysis pertains to Week 3||||0.0372
72549992|NCT03247556|144629738|SUPERIORITY|||||||0.1711|||||||Chi-squared|||This analysis pertains to Week 4||||0.1711
72549993|NCT03247556|144629738|SUPERIORITY|||||||0.1428|||||||Chi-squared|||This analysis pertains to Week 5||||0.1428
72549994|NCT03247556|144629738|SUPERIORITY|||||||0.2148|||||||Chi-squared|||This analysis pertains to Week 6||||0.2148
72549995|NCT03247556|144629738|SUPERIORITY|||||||0.0662|||||||Chi-squared|||This analysis pertains to Week 7||||0.0662
72549996|NCT01682083|144629744|SUPERIORITY|Hazard ratio is obtained from the stratified Pike estimator. A hazard ratio \<1 indicates a lower risk with Dabrafenib + Trametinib compared with Placebo.|Hazard Ratio, log|0.47|||<|0.0001|TWO_SIDED|95.0|0.39|0.58|||Log Rank|||The null hypothesis, H0: λ = 1 or reject it in favor of the alternative hypothesis, HA: λ ≠ 1, where λ is the hazard ratio (HR) of combination therapy relative to placebo.||0.58|0.39|< 0.0001
72549997|NCT01682083|144629745|SUPERIORITY|A hazard ratio \<1 indicates a lower risk with dabrafenib + trametinib compared with Placebo.|Hazard Ratio, log|0.57||||0.006|TWO_SIDED|95.0|0.42|0.79|||Log Rank|the two-sided threshold for significance at this first interim analysis was p=0.000019||Hazard ratio is obtained from the stratified Pike estimator.||0.79|0.42|0.006
72549998|NCT01682083|144629746|SUPERIORITY|A hazard ratio \<1 indicates a lower risk with Dabrafenib + Trametinib compared with Placebo.|Hazard Ratio, log|0.51|||||TWO_SIDED|95.0|0.4|0.65||||||Hazard ratio is estimated using Pike estimator.||0.65|0.40|
72549999|NCT01682083|144629747|SUPERIORITY|A hazard ratio \<1 indicates a lower risk with Dabrafenib + Trametinib compared with Placebo.|Hazard Ratio (HR)|0.47|||||TWO_SIDED|95.0|0.39|0.57||||||Hazard ratio is estimated using Pike estimator.||0.57|0.39|
72550000|NCT03952143|144629748|NON_INFERIORITY|Noninferiority margin = 0.4% for HbA1c|LS Mean Difference|0.07||||0.321|TWO_SIDED|95.0|-0.07|0.21|||Mixed Models Analysis|||||0.21|-0.07|0.321
72550001|NCT03952143|144629749|SUPERIORITY||LS Mean Difference|-14.6|||<|0.001|TWO_SIDED|95.0|-21.9|-7.4|||ANCOVA|||||-7.4|-21.9|<0.001
72550002|NCT03952143|144629750|SUPERIORITY||LS Mean Difference|-21.8|||<|0.001|TWO_SIDED|95.0|-30.9|-12.6|||ANCOVA|||||-12.6|-30.9|<0.001
72550003|NCT03952143|144629751|SUPERIORITY||Relative rate|0.26|||||TWO_SIDED|95.0|0.02|2.86||||||||2.86|0.02|
72583060|NCT01416636|144696620|SUPERIORITY|||||||0.0003|||||||Wilcoxon (Mann-Whitney)|||||||0.0003
72583061|NCT01416636|144696621|SUPERIORITY|||||||0.605|||||||Wilcoxon (Mann-Whitney)|||||||0.605
72550004|NCT03952143|144629752|SUPERIORITY||Relative rate|0.9|||||TWO_SIDED|95.0|0.49|1.66||||||For ≤30 minutes post meal||1.66|0.49|
72583062|NCT01416636|144696622|SUPERIORITY|||||||0.307|||||||Wilcoxon (Mann-Whitney)|||||||0.307
72583063|NCT01416636|144696623|SUPERIORITY|||||||0.0019|||||||Chi-squared|||||||0.0019
72583064|NCT01416636|144696624|SUPERIORITY|||||||0.557|||||||Wilcoxon (Mann-Whitney)|||||||0.557
72583065|NCT01416636|144696625|SUPERIORITY|||||||0.032|||||||Wilcoxon (Mann-Whitney)|||||||0.032
72583066|NCT01416636|144696626|SUPERIORITY|||||||1e-05|||||||Wilcoxon (Mann-Whitney)|||||||0.00001
72550005|NCT03952143|144629752|SUPERIORITY||Relative rate|1.35|||||TWO_SIDED|95.0|0.79|2.31||||||For ≤ 1 hour post meal||2.31|0.79|
72550006|NCT03952143|144629752|SUPERIORITY||Relative rate|1.6|||||TWO_SIDED|95.0|1.06|2.42||||||For \>1 to ≤2 hours post meal||2.42|1.06|
72550007|NCT03952143|144629752|SUPERIORITY||Relative rate|1.53|||||TWO_SIDED|95.0|1.05|2.23||||||For ≤2 hours post meal||2.23|1.05|
72550008|NCT03952143|144629752|SUPERIORITY||Relative rate|0.97|||||TWO_SIDED|95.0|0.69|1.39||||||For \>2 to ≤4 hours post meal||1.39|0.69|
72550009|NCT03952143|144629752|SUPERIORITY||Relative rate|1.15|||||TWO_SIDED|95.0|0.84|1.57||||||For ≤4 hours post meal||1.57|0.84|
72550010|NCT03952143|144629753|SUPERIORITY||LS Mean Difference|-0.29|||||TWO_SIDED|95.0|-1.1|0.53||||||||0.53|-1.10|
72583067|NCT01416636|144696627|SUPERIORITY|||||||3e-06|||||||Wilcoxon (Mann-Whitney)|||||||0.000003
72583068|NCT01416636|144696628|SUPERIORITY|||||||8e-05|||||||Wilcoxon (Mann-Whitney)|||||||0.00008
72583069|NCT01416636|144696629|SUPERIORITY|||||||0.04|||||||Wilcoxon (Mann-Whitney)|||||||0.04
72583070|NCT01416636|144696630|SUPERIORITY|||||||0.227|||||||Wilcoxon (Mann-Whitney)|||||||0.227
72583071|NCT02301169|144696632|NON_INFERIORITY_OR_EQUIVALENCE|Null hypothesis: no difference in mean change from baseline to day 42 of pain severity as measured by weekly means of the daily Average Pain Score (APS), T4P1001 compared with placebo|Mean Difference (Final Values)|0.3748299||||0.4162|TWO_SIDED|95.0|-0.5479411|1.297601||P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment group comparisons|t-test, 2 sided|Welch two sample t-test||||1.2976010|-0.5479411|0.4162
72583072|NCT02301169|144696633|NON_INFERIORITY_OR_EQUIVALENCE|Null hypothesis: no difference in mean change from baseline to day 42 of pain severity as measured by weekly means of the daily Worst Pain Score (WPS), T4P1001 compared with placebo.|Mean Difference (Final Values)|0.1255102||||0.7887|TWO_SIDED|95.0|-0.8152493|1.0662697||P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment group comparisons.|t-test, 2 sided|Welch two sample t-test||||1.0662697|-0.8152493|0.7887
72550011|NCT03952143|144629754|SUPERIORITY||LS Mean Difference|2.2|||||TWO_SIDED|95.0|-2.8|7.2||||||For Morning Premeal||7.2|-2.8|
72550012|NCT03952143|144629754|SUPERIORITY||LS Mean Difference|-5.3|||||TWO_SIDED|95.0|-12.6|2.0||||||For Morning 1-hour Postmeal||2.0|-12.6|
72550013|NCT03952143|144629754|SUPERIORITY||LS Mean Difference|-5.4|||||TWO_SIDED|95.0|-12.5|1.7||||||For Morning 2-hour Postmeal||1.7|-12.5|
72550014|NCT03952143|144629754|SUPERIORITY||LS Mean Difference|4.2|||||TWO_SIDED|95.0|-1.8|10.1||||||For Midday Premeal||10.1|-1.8|
72550015|NCT03952143|144629754|SUPERIORITY||LS Mean Difference|1.2|||||TWO_SIDED|95.0|-5.7|8.1||||||For Midday 1-hour Postmeal||8.1|-5.7|
72550016|NCT03952143|144629754|SUPERIORITY||LS Mean Difference|1.9|||||TWO_SIDED|95.0|-5.1|8.9||||||For Midday 2-hour Postmeal||8.9|-5.1|
72550017|NCT03952143|144629754|SUPERIORITY||LS Mean Difference|14.1|||||TWO_SIDED|95.0|7.6|20.6||||||For Evening Premeal||20.6|7.6|
72550018|NCT03952143|144629754|SUPERIORITY||LS Mean Difference|2.0|||||TWO_SIDED|95.0|-5.1|9.1||||||For Evening 1-hour Postmeal||9.1|-5.1|
72550019|NCT03952143|144629754|SUPERIORITY||LS Mean Difference|-0.2|||||TWO_SIDED|95.0|-7.3|6.8||||||For Evening 2-hour Postmeal||6.8|-7.3|
72550020|NCT03952143|144629754|SUPERIORITY||LS Mean Difference|1.7|||||TWO_SIDED|95.0|-4.7|8.1||||||For Bedtime||8.1|-4.7|
72550021|NCT03952143|144629755|SUPERIORITY||LS Mean Difference|2.8|||||TWO_SIDED|95.0|0.1|5.4||||||For Total Daily Insulin Dose||5.4|0.1|
72550022|NCT03952143|144629755|SUPERIORITY||LS Mean Difference|0.8|||||TWO_SIDED|95.0|0.0|1.5||||||For Daily Basal Insulin Dose||1.5|0.0|
72550023|NCT03952143|144629755|SUPERIORITY||LS Mean Difference|2.0|||||TWO_SIDED|95.0|-0.5|4.5||||||For Daily Prandial Insulin Dose||4.5|-0.5|
72550024|NCT03952143|144629756|SUPERIORITY||Odds Ratio (OR)|1.02||||0.924|TWO_SIDED|95.0|0.69|1.52|||Regression, Logistic|||For HbA1c \< 7%||1.52|0.69|0.924
72550025|NCT03952143|144629756|SUPERIORITY||Odds Ratio (OR)|0.98||||0.908|TWO_SIDED|95.0|0.64|1.49|||Regression, Logistic|||For HbA1c ≤6.5%||1.49|0.64|0.908
72550026|NCT01866319|144629757|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.58|||<|1e-05|TWO_SIDED|95.0|0.46|0.72|||Log Rank|||Statistical testing was stratified by line of therapy (1st vs. 2nd), programmed cell death ligand 1 (PD-L1) status (positive vs. negative) and Eastern Cooperative Oncology Group (ECOG) performance status (0 vs. 1)||0.72|0.46|<0.00001
72550027|NCT01866319|144629757|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.58|||<|1e-05|TWO_SIDED|95.0|0.47|0.72|||Log Rank|||Statistical testing was stratified by line of therapy (1st vs. 2nd), programmed cell death ligand 1 (PD-L1) status (positive vs. negative) and Eastern Cooperative Oncology Group (ECOG) performance status (0 vs. 1)||0.72|0.47|<0.00001
72550028|NCT01866319|144629757|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.97||||0.75869|TWO_SIDED|95.0|0.77|1.21|||Log Rank|||Statistical testing was stratified by line of therapy (1st vs. 2nd), programmed cell death ligand 1 (PD-L1) status (positive vs. negative) and Eastern Cooperative Oncology Group (ECOG) performance status (0 vs. 1)||1.21|0.77|0.75869
72550029|NCT01866319|144629758|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.63||||0.00052|TWO_SIDED|95.0|0.47|0.83|||Regression, Cox|||Statistical testing was stratified by line of therapy (1st vs. 2nd), PD-L1) status (positive vs. negative) and ECOG performance status (0 vs. 1).||0.83|0.47|0.00052
72550030|NCT01866319|144629758|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.69||||0.00358|TWO_SIDED|95.0|0.52|0.9|||Regression, Cox|||Statistical testing was stratified by line of therapy (1st vs. 2nd), PD-L1) status (positive vs. negative) and ECOG performance status (0 vs. 1).||0.90|0.52|0.00358
72550031|NCT01866319|144629758|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.91||||0.51319||95.0|0.67|1.22|||Regression, Cox|||Statistical testing was stratified by line of therapy (1st vs. 2nd), PD-L1) status (positive vs. negative) and ECOG performance status (0 vs. 1).||1.22|0.67|0.51319
72550032|NCT01866319|144629759|SUPERIORITY_OR_OTHER_LEGACY||Percent difference|16.1||||0.00013|TWO_SIDED|95.0|7.8|24.5|||Miettinen & Nurmimen|||Statistical testing was stratified by line of therapy (1st vs. 2nd), PD-L1) status (positive vs. negative) and ECOG performance status (0 vs. 1)||24.5|7.8|0.00013
72550033|NCT01866319|144629759|SUPERIORITY_OR_OTHER_LEGACY||Percent difference|17.2||||2e-05|TWO_SIDED|95.0|9.5|25.6|||Miettinen & Nurmimen|||Statistical testing was stratified by line of therapy (1st vs. 2nd), PD-L1) status (positive vs. negative) and ECOG performance status (0 vs. 1)||25.6|9.5|0.00002
72550034|NCT01866319|144629759|SUPERIORITY_OR_OTHER_LEGACY||Percent difference|-1.1||||0.82636||95.0|-10.6|8.6|||Miettinen & Nurmimen|||Statistical testing was stratified by line of therapy (1st vs. 2nd), PD-L1) status (positive vs. negative) and ECOG performance status (0 vs. 1)||8.6|-10.6|0.82636
72550035|NCT04421508|144629763|SUPERIORITY||Odds Ratio (OR)|0.36||||0.6316|TWO_SIDED|95.0|||||Regression, Logistic|||||||0.6316
72550036|NCT04421508|144629763|SUPERIORITY||Odds Ratio (OR)|1.502||||0.4127|TWO_SIDED|95.0|0.567|3.977||Odds ratio, 95% CI and p-value are from a logistic regression model modelling the response using the covariates treatment, age, number of co-morbidities and baseline oxygem level|Regression, Logistic|||||3.977|0.567|0.4127
72550037|NCT04421508|144629771|SUPERIORITY|||||||0.6635|||||||Chi-squared|||||||0.6635
72550038|NCT03980483|144629773|SUPERIORITY||Odds Ratio (OR)|1.62||||0.0023|TWO_SIDED|0.95|1.19|2.21|||Regression, Logistic|OR and corresponding 95% CI for OR are generated from the logistic regression model adjusted for Baseline TJC68, Baseline SJC66 and Treatment Group.||The null hypothesis is defined as there is no difference between the 90mg dose of GSK3196165 and placebo in the proportion of participants achieving ACR20 response at Week 12, versus the alternative hypothesis that the 90mg dose of GSK3196165 differs from placebo in the proportion of participants achieving ACR20 response at Week 12.||2.21|1.19|0.0023
72552731|NCT00377260|144636482|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Regression, Logistic|The comparison adjusted for site, history of recurrent acute otitis media and exposure to other children.||Null hypothesis: There is no difference between the two groups regarding the proportion of clinical failures by the end of therapy.||||< .001
72552732|NCT00377260|144636483|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||Generalized estimating equations|The comparison was adjusted for site, history of recurrent acute otitis media and exposure to other children.||Null hypothesis: There is no difference between the two groups regarding the symptom burden as measured by the respective mean scores over time.||||.02
72552733|NCT00377260|144636484|SUPERIORITY_OR_OTHER|||||||0.24||95.0|||||Regression, Logistic|The comparison was adjusted for site, history of recurrent acute otitis media and exposure to other children.||Null hypothesis: There is no difference between the two groups regarding the proportion of children who develop worsening symptoms within the first 3 days of treatment.||||.24
72552734|NCT00377260|144636485|SUPERIORITY_OR_OTHER|||||||0.35||95.0||||A weighted regression model was used with weights equal to the number of days information regarding analgesic use was reported by the parents.|Regression, Linear|The comparison was adjusted for site, history of recurrent acute otitis media and exposure to other children.||Null hypothesis: There is no difference between the two groups regarding the average number of doses of analgesic medication administered by parents.||||.35
72552735|NCT00377260|144636486|SUPERIORITY_OR_OTHER|||||||0.04||95.0|||||Regression, Logistic|The comparison was adjusted for site, history of recurrent acute otitis media and exposure to other children.||Null hypothesis: There is no difference between the two treatment groups regarding the proportion of children with protocol-defined diarrhea.||||.04
72550039|NCT03980483|144629773|SUPERIORITY||Odds Ratio (OR)|1.39||||0.0362|TWO_SIDED|0.95|1.02|1.89|||Regression, Logistic|OR and corresponding 95% CI for OR are generated from the logistic regression model adjusted for Baseline TJC68, Baseline SJC66 and Treatment Group.||The null hypothesis is defined as there is no difference between the 150mg dose of GSK3196165 and placebo in the proportion of participants achieving ACR20 response at Week 12, versus the alternative hypothesis that the 150mg dose of GSK3196165 differs from placebo in the proportion of participants achieving ACR20 response at Week 12.||1.89|1.02|0.0362
72550040|NCT03980483|144629773|SUPERIORITY||Odds Ratio (OR)|2.34|||<|0.0001|TWO_SIDED|0.95|1.62|3.37|||Regression, Logistic|OR and corresponding 95% CI for OR are generated from the logistic regression model adjusted for Baseline TJC68, Baseline SJC66 and Treatment Group.||The null hypothesis is defined as there is no difference between the 05mg dose of Tofacitinib and placebo in the proportion of participants achieving ACR20 response at Week 12, versus the alternative hypothesis that the 05mg dose of Tofacitinib differs from placebo in the proportion of participants achieving ACR20 response at Week 12.||3.37|1.62|<0.0001
72550041|NCT03980483|144629773|SUPERIORITY||Odds Ratio (OR)|0.69||||0.023|TWO_SIDED|0.95|0.5|0.95|||Regression, Logistic|OR and corresponding 95% CI for OR are generated from the logistic regression model adjusted for Baseline TJC68, Baseline SJC66 and Treatment Group.||The null hypothesis is defined as there is no difference between the 90mg dose of GSK3196165 and 05mg dose of Tofacitinib in the proportion of participants achieving ACR20 response at Week 12, versus the alternative hypothesis that the 90mg dose of GSK3196165 differs from 05mg dose of Tofacitinib in the proportion of participants achieving ACR20 response at Week 12.||0.95|0.50|0.0230
72550042|NCT03980483|144629773|SUPERIORITY||Odds Ratio (OR)|0.59||||0.0013|TWO_SIDED|0.95|0.43|0.82|||Regression, Logistic|OR and corresponding 95% CI for OR are generated from the logistic regression model adjusted for Baseline TJC68, Baseline SJC66 and Treatment Group.||The null hypothesis is defined as there is no difference between the 150mg dose of GSK3196165 and 05mg dose of Tofacitinib in the proportion of participants achieving ACR20 response at Week 12, versus the alternative hypothesis that the 150mg dose of GSK3196165 differs from 05mg dose of Tofacitinib in the proportion of participants achieving ACR20 response at Week 12.||0.82|0.43|0.0013
72550043|NCT03980483|144629776|NON_INFERIORITY|Non-inferiority over tofacitinib on ACR20 was concluded if the lower limit of the multiplicity corrected 97.5 % Confidence Interval (CI) in the difference in proportions (GSK3196165 minus tofacitinib) was greater than -12%|Mean Difference (Final Values)|-10.4|||||TWO_SIDED|0.975|-18.6|-2.3|||Regression, Logistic|Difference in proportion and 97.5% CI are generated from logistic regression model adjusted for Baseline TJC68, Baseline SJC66 and Treatment Group.||||-2.3|-18.6|
72550044|NCT03980483|144629776|NON_INFERIORITY|Non-inferiority over tofacitinib on ACR20 was concluded if the lower limit of the multiplicity corrected 97.5% CI in the difference in proportions (GSK3196165 minus tofacitinib) was greater than -12%|Mean Difference (Final Values)|-13.0|||||TWO_SIDED|0.975|-21.2|-4.8|||Regression, Logistic|Difference in proportion and 97.5% CI are generated from logistic regression model adjusted for Baseline TJC68, Baseline SJC66 and Treatment Group.||||-4.8|-21.2|
72550045|NCT01050647|144630094|SUPERIORITY|||||||0.31|||||||Chi-squared|||||||0.31
72550046|NCT01050647|144630095|SUPERIORITY||||||>|0.99|||||||Chi-squared|||||||>0.99
72550047|NCT01050647|144630096|SUPERIORITY|||||||0.59|||||||Chi-squared|||||||0.59
72550048|NCT01050647|144630097|SUPERIORITY|||||||0.16|||||||Wilcoxon (Mann-Whitney)|||||||0.16
72583073|NCT02301169|144696634|NON_INFERIORITY_OR_EQUIVALENCE|Null hypothesis: no difference in mean change from baseline to day 42 of pain severity as measured by Investigator Global Assessment of Change, T4P1001 compared with Placebo|Mean Difference (Final Values)|0.802381||||0.2353|TWO_SIDED|95.0|-0.5457743|2.1505362||P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment group comparisons.|t-test, 2 sided|Welch two sample t-test||||2.1505362|-0.5457743|0.2353
72583074|NCT02301169|144696635|NON_INFERIORITY_OR_EQUIVALENCE|Null hypothesis: no difference in mean change from baseline to day 42 of pain intensity measured after heat pain stimuli, T4P1001 compared with placebo.|Mean Difference (Final Values)|0.7656429||||0.06204|TWO_SIDED|95.0|-0.0406744|1.5719601||P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment group comparisons.|t-test, 2 sided|Welch two sample t-test||||1.5719601|-0.0406744|0.06204
72550049|NCT01050647|144630098|SUPERIORITY|||||||0.14|||||||Wilcoxon (Mann-Whitney)|||||||0.14
72550050|NCT03249584|144630212|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||An improvement from baseline to 3 months post radiofrequency ablation in worst pain score will be demonstrated with an outcome which is statistically lower than zero.||||<0.0001
72550051|NCT00659607|144630216|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test for paired observations|||||||<0.0001
72550052|NCT00659607|144630217|SUPERIORITY_OR_OTHER|||||||0.2669|||||||Chi-squared|||||||0.2669
72550053|NCT00659607|144630218|SUPERIORITY_OR_OTHER|||||||0.9674|||||||Chi-squared|||||||0.9674
72550054|NCT00659607|144630219|SUPERIORITY_OR_OTHER|||||||0.9207|||||||Chi-squared|||||||0.9207
72550055|NCT00659607|144630220|SUPERIORITY_OR_OTHER|||||||0.8249|||||||Fisher Exact|||||||0.8249
72550056|NCT00659607|144630221|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test for paired observations|||||||<0.0001
72550057|NCT00659607|144630223|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.2||||0.0003|TWO_SIDED|95.0|1.121|4.151|||Chi-squared||The estimation of Odds Ratio and 95% Confidence Interval based on the logistic regression analysis|||4.151|1.121|0.0003
72550058|NCT00659607|144630224|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.3|||<|0.0001|TWO_SIDED|95.0|1.642|6.776|||Chi-squared||The Estimation of Odds Ratio and 95% Confidence Interval based the logistic regression analysis|||6.776|1.642|<0.0001
72550059|NCT00659607|144630225|SUPERIORITY_OR_OTHER|||||||0.0075|||||||Chi-squared|||||||0.0075
72583075|NCT02301169|144696636|NON_INFERIORITY_OR_EQUIVALENCE|Null hypothesis: no difference in mean change from baseline to day 42 of pain severity as measured by the Brief Pain Inventory (BPI), T4P1001 compared with placebo.|Mean Difference (Final Values)|1.683333||||0.3386|TWO_SIDED|95.0|-1.83119|5.197857||P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment group comparisons.|t-test, 2 sided|Welch two sample t-test||||5.197857|-1.831190|0.3386
72583076|NCT02949973|144696643|OTHER||Percentage|70.0|||||TWO_SIDED|||||||||||||
72583077|NCT02949973|144696644|OTHER||Percentage|40.0|||||TWO_SIDED|||||||||||||
72583078|NCT02949973|144696645|OTHER||Percentage|20.0|||||TWO_SIDED|||||||||||||
72583079|NCT02949973|144696646|OTHER||Percentage|20.0|||||TWO_SIDED|||||||||||||
72550060|NCT00659607|144630226|SUPERIORITY_OR_OTHER|||||||0.0007|||||||Chi-squared|||||||0.0007
72412801|NCT02417246|144333695|EQUIVALENCE|A mixed effect model for repeated measures was used to model medication effect on HRV comparing brand name metoprolol ER to Generic A, adjusting for quartile,(quartile\*med) interaction, and treatment assignment.|Slope|-0.6|STANDARD_ERROR_OF_MEAN|0.3||0.0168|TWO_SIDED||||||Mixed Models Analysis||p for medication\*quartile interaction considered significant if p\<0.025.|||||0.0168
72550061|NCT00659607|144630227|SUPERIORITY_OR_OTHER|||||||0.0393|||||||Chi-squared|||||||0.0393
72550062|NCT00659607|144630228|SUPERIORITY_OR_OTHER|||||||0.0245|||||||Chi-squared|||||||0.0245
72550063|NCT00486837|144630235|SUPERIORITY_OR_OTHER|||||||0.197||95.0|||||ANCOVA|||||||0.197
72550064|NCT02724800|144630241|NON_INFERIORITY|non-inferiority margin = 3.43|Mean Difference (Net)|2.2|||<|0.05|TWO_SIDED|95.0|-0.9|5.6||a priori|Mixed Models Analysis|||||5.6|-0.9|<0.05
72550065|NCT02724800|144630248|SUPERIORITY||Mean Difference (Final Values)|2.3|||<|0.05|TWO_SIDED||||||Mixed Models Analysis|||||||<0.05
72550066|NCT02724800|144630251|SUPERIORITY||Mean Difference (Final Values)|0.3|||<|0.05|TWO_SIDED||||||Mixed Models Analysis|||||||<0.05
72550067|NCT00262964|144630278|SUPERIORITY_OR_OTHER||||||<|0.019||95.0|||||t-test, 2 sided|||null hypothesis was no difference in hepatic insulin sensitivity between normal and high IHTG subjects||||<0.019
72583080|NCT02949973|144696647|OTHER||Percentage|70.0|||||TWO_SIDED|95.0|34.8|93.3||||||||93.3|34.8|
72583081|NCT02949973|144696648|OTHER||Percentage|50.0|||||TWO_SIDED|95.0|15.7|84.3||||||||84.3|15.7|
72583082|NCT01422213|144696651|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.363|STANDARD_ERROR_OF_MEAN|0.072|<|0.0001|TWO_SIDED|95.0|0.22|0.5||To adjust for multiplicity, the 10 and 20 mg doses of vortioxetine were tested separately versus placebo in the primary and key secondary efficacy analyses at a Bonferroni-corrected significance level of 0.05/2 = 0.025.|Mixed Models Analysis|||Based on the FAS, the composite z-score was analysed using the mixed model for repeated measurements (MMRM) with an unstructured covariance structure. The model included terms for grouped site, baseline composite z-score, baseline composite z-score-by-visit interaction, and treatment-by-visit interaction.||0.50|0.22|<0.0001
72583083|NCT01422213|144696651|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.33|STANDARD_ERROR_OF_MEAN|0.071|<|0.0001|TWO_SIDED|95.0|0.19|0.47||To adjust for multiplicity, the 10 and 20 mg doses of vortioxetine were tested separately versus placebo in the primary and key secondary efficacy analyses at a Bonferroni-corrected significance level of 0.05/2 = 0.025.|Mixed Models Analysis|||Based on the FAS, the composite z-score was analysed using the MMRM with an unstructured covariance structure. The model included terms for grouped site, baseline composite z-score, baseline composite z-score-by-visit interaction, and treatment-by-visit interaction.||0.47|0.19|<0.0001
72583084|NCT01422213|144696652|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.2|STANDARD_ERROR_OF_MEAN|0.87|<|0.0001|TWO_SIDED|95.0|2.5|5.9||To adjust for multiplicity, the 10 and 20 mg doses of vortioxetine were tested separately versus placebo in the primary and key secondary efficacy analyses at a Bonferroni-corrected significance level of 0.05/2 = 0.025.|Mixed Models Analysis|||Based on the FAS, the DSST (number of correct symbols) was analysed using the MMRM with an unstructured covariance structure. The model included terms for grouped site, baseline value, baseline value-by-visit interaction, and treatment-by-visit interaction.||5.90|2.50|<0.0001
72583085|NCT01422213|144696652|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.26|STANDARD_ERROR_OF_MEAN|0.86|<|0.0001|TWO_SIDED|95.0|2.57|5.94||To adjust for multiplicity, the 10 and 20 mg doses of vortioxetine were tested separately versus placebo in the primary and key secondary efficacy analyses at a Bonferroni-corrected significance level of 0.05/2 = 0.025.|Mixed Models Analysis|||Based on the FAS, the DSST (number of correct symbols) was analysed using the MMRM with an unstructured covariance structure. The model included terms for grouped site, baseline value, baseline value-by-visit interaction, and treatment-by-visit interaction.||5.94|2.57|<0.0001
72583086|NCT01422213|144696653|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.02|STANDARD_ERROR_OF_MEAN|0.46||0.0287|TWO_SIDED|95.0|0.11|1.93||To adjust for multiplicity, the 10 and 20 mg doses of vortioxetine were tested separately versus placebo in the primary and key secondary efficacy analyses at a Bonferroni-corrected significance level of 0.05/2 = 0.025.|Mixed Models Analysis|||Based on the FAS, the RAVLT (acquisition) was analysed using the MMRM with an unstructured covariance structure. The model included terms for grouped site, baseline value, baseline value-by-visit interaction, and treatment-by-visit interaction.||1.93|0.11|0.0287
72583087|NCT01422213|144696653|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.59|STANDARD_ERROR_OF_MEAN|0.46||0.1988|TWO_SIDED|95.0|-0.31|1.5||To adjust for multiplicity, the 10 and 20 mg doses of vortioxetine were tested separately versus placebo in the primary and key secondary efficacy analyses at a Bonferroni-corrected significance level of 0.05/2 = 0.025.|Mixed Models Analysis|||Based on the FAS, the RAVLT (acquisition) was analysed using the MMRM with an unstructured covariance structure. The model included terms for grouped site, baseline value, baseline value-by-visit interaction, and treatment-by-visit interaction.||1.50|-0.31|0.1988
72583088|NCT01422213|144696654|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.71|STANDARD_ERROR_OF_MEAN|0.24||0.0033|TWO_SIDED|95.0|0.24|1.19||Since the p-value for RAVLT acquisition for 10 mg was \>0.025, the p-value for this test is nominal.|Mixed Models Analysis|||Based on the FAS, the RAVLT (delayed recall) was analysed using the MMRM with an unstructured covariance structure. The model included terms for grouped site, baseline value, baseline value-by-visit interaction, and treatment-by-visit interaction.||1.19|0.24|0.0033
72583089|NCT01422213|144696654|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.65|STANDARD_ERROR_OF_MEAN|0.24||0.0073|TWO_SIDED|95.0|0.17|1.12||Since the p-value for RAVLT acquisition for 20 mg was \>0.025, the p-value for this test is nominal.|Mixed Models Analysis|||Based on the FAS, the RAVLT (delayed recall) was analysed using the MMRM with an unstructured covariance structure. The model included terms for grouped site, baseline value, baseline value-by-visit interaction, and treatment-by-visit interaction.||1.12|0.17|0.0073
72583090|NCT01422213|144696655|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.76|STANDARD_ERROR_OF_MEAN|1.37||0.0061|TWO_SIDED|95.0|-6.45|-1.08||No adjustment for multiplicity was made.|Mixed Models Analysis|||Based on the FAS, the TMT A (Speed of Processing) was analysed using the MMRM with an unstructured covariance structure. The model included terms for grouped site, baseline value, baseline value-by-visit interaction, and treatment-by-visit interaction.||-1.08|-6.45|0.0061
72412802|NCT02417246|144333696|EQUIVALENCE|A mixed effect model for repeated measures was performed to model the 24-hour ambulatory systolic blood pressure (SBP) by quartile for 35 patients receiving brand name metoprolol ER and Generic B.|Slope|-2.39||||0.203|TWO_SIDED||||||Mixed Models Analysis|||||||0.203
72550068|NCT00262964|144630279|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||a priori threshold for significance was P\<0.05.|t-test, 2 sided|||null hypothesis was that VLDL-TG production would not differ between the two groups.||||<0.001
72550069|NCT00262964|144630280|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||a priori threshold for significance was set at p = 0.05.|t-test, 2 sided|||null hypothesis was no difference in skeletal muscle insulin sensitivity between groups.||||<0.001
72550070|NCT00262964|144630281|SUPERIORITY_OR_OTHER||||||<|0.002||95.0|||||t-test, 2 sided|||null hypothesis was that there would be no difference in adipose tissue insulin sensitivity due to IHTG levels.||||<0.002
72550071|NCT00262964|144630282|SUPERIORITY_OR_OTHER|||||||0.301||95.0||||A P-value \< 0.05 was considered statistically significant.|t-test, 2 sided|Treatment effects determined by repeated-measures ANOVA. When significant interactions between time and group were found, a Student's t-test was used.||Student's t-test for paired samples was used to evaluate any difference between the two groups. The null hypothesis was that the IHTG percentage would be the same before and after treatment for subjects receiving fenofibrate.||||.301
72550072|NCT00262964|144630282|SUPERIORITY_OR_OTHER|||||||0.315||95.0||||A P-value \< 0.05 was considered statistically significant.|t-test, 2 sided|Treatment effects determined by repeated-measures ANOVA. When significant interactions between time and group were found, a Student's t-test was used.||A Student's t-test for paired samples was used to evaluate the effect of treatment. The null hypothesis was that the IHTG percentage for the NAFLD-niacin group at baseline and post-treatment would not change.||||.315
72550073|NCT00262964|144630283|SUPERIORITY_OR_OTHER|||||||0.708||95.0||||A P-value \< 0.05 was considered statistically significant.|t-test, 2 sided|||a Student's t-test for paired samples was used to evaluate the effect of treatment. Null hypothesis was that VLDL-apoB would be the same before and after 16 weeks on niacin in subjects with NAFLD.||||0.708
72550074|NCT00262964|144630283|SUPERIORITY_OR_OTHER|||||||0.022||95.0||||A P-value \< 0.05 was considered statistically significant.|t-test, 2 sided|||A Student's t-test for paired samples was used to evaluate the effect of treatment. Null hypothesis was that VLDL-apoB would be the same before and after 8 weeks on fenofibrate in subjects with NAFLD.||||.022
72583091|NCT01422213|144696655|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.8|STANDARD_ERROR_OF_MEAN|1.35||0.0052|TWO_SIDED|95.0|-6.46|-1.14||No adjustment for multiplicity was made.|Mixed Models Analysis|||Based on the FAS, the TMT A (Speed of Processing) was analysed using the MMRM with an unstructured covariance structure. The model included terms for grouped site, baseline value, baseline value-by-visit interaction, and treatment-by-visit interaction.||-1.14|-6.46|0.0052
72550075|NCT00262964|144630284|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||t-test, 2 sided|||the null hypothesis was that fenofibrate would not change the VLDL-Tg clearance rate||||.020
72583092|NCT01422213|144696656|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.57|STANDARD_ERROR_OF_MEAN|2.73||0.0058|TWO_SIDED|95.0|-12.93|-2.2||No adjustment for multiplicity was made.|Mixed Models Analysis|||Based on the FAS, the TMT B (Executive Function) was analysed using the MMRM with an unstructured covariance structure. The model included terms for grouped site, baseline value, baseline value-by-visit interaction, and treatment-by-visit interaction.||-2.20|-12.93|0.0058
72583093|NCT01422213|144696656|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.01|STANDARD_ERROR_OF_MEAN|2.7||0.0009|TWO_SIDED|95.0|-14.32|-3.7||No adjustment for multiplicity was made.|Mixed Models Analysis|||Based on the FAS, the TMT B (Executive Function) was analysed using the MMRM with an unstructured covariance structure. The model included terms for grouped site, baseline value, baseline value-by-visit interaction, and treatment-by-visit interaction.||-3.70|-14.32|0.0009
72583094|NCT01422213|144696657|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.0|STANDARD_ERROR_OF_MEAN|1.28||0.0018|TWO_SIDED|95.0|-6.5|-1.49||No adjustment for multiplicity was made.|Mixed Models Analysis|||Based on the FAS, the Congruent STROOP Time to Complete (Executive Function) was analysed using the MMRM with an unstructured covariance structure. The model included terms for grouped site, baseline value, baseline value-by-visit interaction, and treatment-by-visit interaction.||-1.49|-6.50|0.0018
72583095|NCT01422213|144696657|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.45|STANDARD_ERROR_OF_MEAN|1.26||0.0005|TWO_SIDED|95.0|-6.93|-1.97||No adjustment for multiplicity was made.|Mixed Models Analysis|||Based on the FAS, the Congruent STROOP Time to Complete (Executive Function) was analysed using the MMRM with an unstructured covariance structure. The model included terms for grouped site, baseline value, baseline value-by-visit interaction, and treatment-by-visit interaction.||-1.97|-6.93|0.0005
72583096|NCT01422213|144696658|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.75|STANDARD_ERROR_OF_MEAN|2.04||0.001|TWO_SIDED|95.0|-10.76|-2.74||No adjustment for multiplicity was made.|Mixed Models Analysis|||Based on the FAS, the Incongruent STROOP Time to Complete (Executive Function) was analysed using the MMRM with an unstructured covariance structure. The model included terms for grouped site, baseline value, baseline value-by-visit interaction, and treatment-by-visit interaction.||-2.74|-10.76|0.0010
72550076|NCT00262964|144630284|SUPERIORITY_OR_OTHER|||||||0.358||95.0||||a priori threshold for significance was \<0.05.|t-test, 2 sided|||the null hypothesis was that niacin would not change the VLDL-Tg clearance rate||||.358
72550077|NCT00262964|144630285|SUPERIORITY_OR_OTHER|||||||0.758||95.0||||a priori threshold for statistical significance was set at \<0.05.|t-test, 2 sided|||Null hypothesis is that fenofibrate would not effect VLDL-Tg production rates.||||0.758
72550078|NCT00262964|144630285|SUPERIORITY_OR_OTHER|||||||0.023||95.0||||the a priori threshold for statistical significance was set at \<0.05.|t-test, 2 sided|||Null hypothesis is that niacin would not effect VLDL-Tg production rates.||||.023
72550079|NCT00262964|144630286|SUPERIORITY_OR_OTHER|||||||0.024||95.0||||the a priori threshold for statistical significance was p \<0.05|t-test, 2 sided|||Null hypothesis was that fenofibrate would not affect VLDL-Tg concentration. We compare the pre and post-treatment results of subjects receiving an 8 week course of fenofibrate.||||.024
72550080|NCT00262964|144630286|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||the a priori threshold for statistical significance was p\<0.05|t-test, 2 sided|||The null hypothesis was that niacin would not affect VLDL-Tg concentration. We compare the pre and post-treatment results of subjects receiving a 16 week course of niacin.||||<0.001
72583097|NCT01422213|144696658|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.52|STANDARD_ERROR_OF_MEAN|2.02||0.0013|TWO_SIDED|95.0|-10.49|-2.54||No adjustment for multiplicity was made.|Mixed Models Analysis|||Based on the FAS, the Incongruent STROOP Time to Complete (Executive Function) was analysed using the MMRM with an unstructured covariance structure. The model included terms for grouped site, baseline value, baseline value-by-visit interaction, and treatment-by-visit interaction.||-2.54|-10.49|0.0013
72583098|NCT01422213|144696659|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.046|STANDARD_ERROR_OF_MEAN|0.012||0.0002|TWO_SIDED|95.0|-0.07|-0.02||No adjustment for multiplicity was made.|Mixed Models Analysis|||Based on the FAS, the SRT (Speed of Processing) was analysed using the MMRM with an unstructured covariance structure. The model included terms for grouped site, baseline value, baseline value-by-visit interaction, and treatment-by-visit interaction.||-0.02|-0.07|0.0002
72583099|NCT01422213|144696659|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.029|STANDARD_ERROR_OF_MEAN|0.012||0.0157|TWO_SIDED|95.0|-0.05|-0.01||No adjustment for multiplicity was made.|Mixed Models Analysis|||Based on the FAS, the SRT (Speed of Processing) was analysed using the MMRM with an unstructured covariance structure. The model included terms for grouped site, baseline value, baseline value-by-visit interaction, and treatment-by-visit interaction.||-0.01|-0.05|0.0157
72583100|NCT01422213|144696660|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.032|STANDARD_ERROR_OF_MEAN|0.009||0.0005|TWO_SIDED|95.0|-0.05|-0.01||No adjustment for multiplicity was made.|Mixed Models Analysis|||Based on the FAS, the CRT (Attention) was analysed using the MMRM with an unstructured covariance structure. The model included terms for grouped site, baseline value, baseline value-by-visit interaction, and treatment-by-visit interaction.||-0.01|-0.05|0.0005
72583101|NCT01422213|144696660|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.008|STANDARD_ERROR_OF_MEAN|0.009||0.3549|TWO_SIDED|95.0|-0.03|0.01||No adjustment for multiplicity was made.|Mixed Models Analysis|||Based on the FAS, the CRT (Attention) was analysed using the MMRM with an unstructured covariance structure. The model included terms for grouped site, baseline value, baseline value-by-visit interaction, and treatment-by-visit interaction.||0.01|-0.03|0.3549
72583102|NCT01422213|144696661|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.7|STANDARD_ERROR_OF_MEAN|0.89|<|0.0001|TWO_SIDED|95.0|-6.45|-2.96||No adjustment for multiplicity was made.|Mixed Models Analysis|||Based on the FAS, the MADRS Total Score was analysed using the MMRM with an unstructured covariance structure. The model included terms for grouped site, baseline value, baseline value-by-visit interaction, and treatment-by-visit interaction.||-2.96|-6.45|<0.0001
72583103|NCT01422213|144696661|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.7|STANDARD_ERROR_OF_MEAN|0.88|<|0.0001|TWO_SIDED|95.0|-8.43|-4.98||No adjustment for multiplicity was made.|Mixed Models Analysis|||Based on the FAS, the MADRS Total Score was analysed using the MMRM with an unstructured covariance structure. The model included terms for grouped site, baseline value, baseline value-by-visit interaction, and treatment-by-visit interaction.||-4.98|-8.43|<0.0001
72583104|NCT01422213|144696662|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.65|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-0.88|-0.42||No adjustment for multiplicity was made.|Mixed Models Analysis|||Based on the FAS, the CGI-S Score was analysed using the MMRM with an unstructured covariance structure. The model included terms for grouped site, baseline value, baseline value-by-visit interaction, and treatment-by-visit interaction.||-0.42|-0.88|<0.0001
72412803|NCT02417246|144333696|EQUIVALENCE|A mixed effect model for repeated measures was performed to model the 24-hour ambulatory diastolic blood pressure (DBP) by quartile for 35 patients receiving brand name metoprolol ER and Generic B.|Slope|-0.543||||0.671|TWO_SIDED||||||Mixed Models Analysis|||||||0.671
72550081|NCT00262964|144630287|SUPERIORITY_OR_OTHER|||||||0.768||95.0||||A priori threshold for significance was set for p\<0.05.|t-test, 2 sided|||Null hypothesis was that fenofibrate would not affect adipose tissue insulin sensitivity. We compare the baseline and post-treatment results for adipose tissue insulin sensitivity in the subjects who received fenofibrate.||||.768
72550082|NCT00262964|144630287|SUPERIORITY_OR_OTHER|||||||0.019||95.0||||A priori threshold for significance was set for p\<0.05.|t-test, 2 sided|||Null hypothesis was that niacin would not affect adipose tissue insulin sensitivity. Here we compare the baseline and post-treatment adipose tissue insulin sensitivity results for subjects who received a 16 week course of niacin||||.019
72550083|NCT00262964|144630288|SUPERIORITY_OR_OTHER|||||||0.318||95.0||||The a priori threshold for significance was set at p\<0.05.|t-test, 2 sided|||The null hypothesis was that fenofibrate would not affect skeletal muscle insulin sensitivity. Here we compare the pre and post-treatment results in subjects receiving an 8 week course of fenofibrate.||||.318
72550084|NCT00262964|144630288|SUPERIORITY_OR_OTHER|||||||0.025||95.0||||The a priori threshold for significance was set at p\<0.05.|t-test, 2 sided|||The null hypothesis was that niacin would not affect skeletal muscle insulin sensitivity. Here we compare the pre and post-treatment results for subjects receiving a 16 week course of niacin.||||.025
72550085|NCT00262964|144630289|SUPERIORITY_OR_OTHER|||||||0.419||95.0||||The a priori threshold for significance was set at p\<0.05.|t-test, 2 sided|||The null hypothesis was that fenofibrate would not affect hepatic insulin sensitivity. Here we compare the pre and post-treatment results of subjects receiving an 8 week course of fenofibrate.||||.419
72550086|NCT00262964|144630289|SUPERIORITY_OR_OTHER|||||||0.018||95.0||||The a priori threshold for significance was set at p\<0.05.|t-test, 2 sided|||The null hypothesis was that niacin would not affect skeletal muscle insulin sensitivity. Here we compare the pre and post-treatment results of subjects receiving a 16 week course of niacin.||||.018
72550087|NCT03130699|144630304|SUPERIORITY|||||||0.95|||||||Regression, Logistic|||Analyses controlled for age, gender, employment and language.||||0.95
72550088|NCT03130699|144630305|SUPERIORITY|||||||0.37|||||||Regression, Logistic|||Analyses controlled for age, gender, employment, and language.||||0.37
72550089|NCT03130699|144630306|SUPERIORITY|||||||0.26|||||||Regression, Logistic|||Analyses controlled for age, gender, employment, and language.||||0.26
72550090|NCT03130699|144630307|SUPERIORITY|||||||0.9|||||||Regression, Logistic|||Analyses controlled for age, gender, employment, and language.||||0.90
72550091|NCT03130699|144630308|SUPERIORITY|||||||0.21|||||||Regression, Logistic|||Analyses controlled for age, gender, employment, and language.||||0.21
72550092|NCT03130699|144630309|SUPERIORITY|||||||0.3|||||||Regression, Logistic|||Analyses controlled for age, gender, employment, and language.||||0.30
72550093|NCT03130699|144630310|SUPERIORITY|||||||0.9|||||||Regression, Logistic|||Analyses controlled for income.||||0.90
72550094|NCT03130699|144630311|SUPERIORITY|||||||0.72|||||||Regression, Logistic|||Analyses controlled for income.||||0.72
72550095|NCT03130699|144630312|SUPERIORITY|||||||0.61|||||||Regression, Logistic|||Analyses controlled for income.||||0.61
72550096|NCT03130699|144630313|SUPERIORITY|||||||0.49|||||||Regression, Logistic|||Analyses controlled for income.||||0.49
72550097|NCT03130699|144630314|SUPERIORITY|||||||0.96|||||||Regression, Logistic|||Analyses controlled for income.||||0.96
72550098|NCT03130699|144630315|SUPERIORITY|||||||0.64|||||||Regression, Logistic|||Analyses controlled for income.||||0.64
72550099|NCT03130699|144630316|SUPERIORITY|||||||0.87|||||||Regression, Logistic|||Binary logistic analyses were conducted for this outcome. Unstandardized regression coefficients represent logit coefficients.||||0.87
72550100|NCT03130699|144630317|SUPERIORITY|||||||0.58|||||||Regression, Logistic|||Binary logistic regression analyses were conducted for this outcome. Unstandardized regression coefficients represent logit coefficients.||||0.58
72550101|NCT03130699|144630318|SUPERIORITY|||||||0.25|||||||Regression, Logistic|||Binary logistic regression analyses were conducted for this outcome. Unstandardized regression coefficients represent logit coefficients.||||0.25
72550102|NCT03130699|144630319|SUPERIORITY|||||||0.11|||||||Regression, Logistic|||Binary logistic regression analyses were conducted for this outcome. Unstandardized regression coefficients represent logit coefficients.||||0.11
72550103|NCT03130699|144630320|SUPERIORITY|||||||0.76|||||||Regression, Logistic|||Analyses controlled for income.||||0.76
72550104|NCT03130699|144630321|SUPERIORITY|||||||0.05|||||||Regression, Logistic|||Analyses controlled for income.||||0.05
72550105|NCT03130699|144630322|SUPERIORITY|||||||0.63|||||||Regression, Logistic|||Analyses controlled for income.||||0.63
72550106|NCT03130699|144630323|SUPERIORITY|||||||0.63|||||||Regression, Logistic|||Analyses is controlled for income.||||0.63
72550107|NCT03130699|144630324|SUPERIORITY|||||||0.002|||||||Regression, Logistic|||Analyses controlled for income.||||0.002
72550108|NCT03130699|144630325|SUPERIORITY|||||||0.008|||||||Regression, Logistic|||Analyses controlled for income.||||0.008
72550109|NCT01199861|144630330|SUPERIORITY_OR_OTHER||Percent Inhibition|41.0||||||95.0|||||||One minus the back-transformed estimate for the treatment difference was interpreted as the relative inhibition of an immune response caused by fingolimod 0.5 mg compared to placebo; it was presented as a percentage and referred to as 'inhibition'.|The inhibition of an immune response to the A/California/7/09 (H1N1) strain of the seasonal influenza vaccine was assessed by the relative difference of the geometric mean antibody titer ratio on fingolimod as compared to placebo three weeks after a single dose of seasonal influenza vaccine.||||
72550110|NCT01199861|144630330|SUPERIORITY_OR_OTHER||Percent Inhibition|-35.0||||||95.0|||||||One minus the back-transformed estimate for the treatment difference was interpreted as the relative inhibition of an immune response caused by fingolimod 0.5 mg compared to placebo; it was presented as a percentage and referred to as 'inhibition'.|The inhibition of an immune response to the A/Perth/16/2009 (H3N2) strain of the seasonal influenza vaccine was assessed by the relative difference of the geometric mean antibody titer ratio on fingolimod as compared to placebo three weeks after a single dose of seasonal influenza vaccine.||||
72550111|NCT01199861|144630330|SUPERIORITY_OR_OTHER||Percent Inhibition|44.0||||||95.0|||||||One minus the back-transformed estimate for the treatment difference was interpreted as the relative inhibition of an immune response caused by fingolimod 0.5 mg compared to placebo; it was presented as a percentage and referred to as 'inhibition'.|The inhibition of an immune response to the B/Brisbane/60/2008 strain of the seasonal influenza vaccine was assessed by the relative difference of the geometric mean antibody titer ratio on fingolimod as compared to placebo three weeks after a single dose of seasonal influenza vaccine.||||
72552736|NCT00377260|144636486|SUPERIORITY_OR_OTHER||||||<|0.01||95.0|||||Regression, Logistic|The comparison was adjusted for site, history of recurrent acute otitis media and exposure to other children.||Null hypothesis: There is no difference between the two treatment groups regarding the proportion of children with diaper dermatitis.||||<.01
72412804|NCT02417246|144333696|EQUIVALENCE|A mixed effect model for repeated measures was performed to model the 24-hour ambulatory SBP by quartile for 35 patients receiving brand name metoprolol ER and Generic A.|Slope|-2.371||||0.2|TWO_SIDED||||||Mixed Models Analysis|||||||0.200
72550112|NCT01199861|144630331|SUPERIORITY_OR_OTHER||Percent Inhibition|38.0||||||95.0|||||||One minus the back-transformed estimate for the treatment difference was interpreted as the relative inhibition of an immune response caused by fingolimod 0.5 mg compared to placebo; it was presented as a percentage and referred to as 'inhibition'.|The inhibition of an immune response to the A/California/7/09 (H1N1) strain of the seasonal influenza vaccine was assessed by the relative difference of the geometric mean antibody titer ratio on fingolimod as compared to placebo six weeks after a single dose of seasonal influenza vaccine.||||
72550113|NCT01199861|144630331|SUPERIORITY_OR_OTHER||Percent Inhibition|-28.0||||||95.0|||||||One minus the back-transformed estimate for the treatment difference was interpreted as the relative inhibition of an immune response caused by fingolimod 0.5 mg compared to placebo; it was presented as a percentage and referred to as 'inhibition'.|The inhibition of an immune response to the A/Perth/16/2009 (H3N2) strain of the seasonal influenza vaccine was assessed by the relative difference of the geometric mean antibody titer ratio on fingolimod as compared to placebo six weeks after a single dose of seasonal influenza vaccine.||||
72550114|NCT01199861|144630331|SUPERIORITY_OR_OTHER||Percent Inhibition|48.0||||||95.0|||||||One minus the back-transformed estimate for the treatment difference was interpreted as the relative inhibition of an immune response caused by fingolimod 0.5 mg compared to placebo; it was presented as a percentage and referred to as 'inhibition'.|The inhibition of an immune response to the B/Brisbane/60/2008 strain of the seasonal influenza vaccine was assessed by the relative difference of the geometric mean antibody titer ratio on fingolimod as compared to placebo six weeks after a single dose of seasonal influenza vaccine.||||
72550115|NCT00669864|144630333|SUPERIORITY_OR_OTHER||Estimated mean|-1.303|STANDARD_ERROR_OF_MEAN|0.056|<|0.0001||95.0|-1.414|-1.192||A significant mean HbA1c decrease was to be declared if H0 is rejected at a significance level of 2.5%.|t-test, 1 sided|||The null hypothesis (H0): HbA1c after 16 weeks - HbA1c at baseline ≥ 0% against the alternative hypothesis (H1): HbA1c after 16 weeks - HbA1c at baseline \< 0%. If H0 rejected at a significance level of 2.5%, declare a significant mean HbA1c decrease||-1.192|-1.414|<0.0001
72550116|NCT01822548|144630353|OTHER||||||<|0.05|||||||Regression, Linear|Generalized linear model (GLM)||||||<0.05
72583105|NCT01422213|144696662|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.85|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-1.08|-0.62||No adjustment for multiplicity was made.|Mixed Models Analysis|||Based on the FAS, the CGI-S Score was analysed using the MMRM with an unstructured covariance structure. The model included terms for grouped site, baseline value, baseline value-by-visit interaction, and treatment-by-visit interaction.||-0.62|-1.08|<0.0001
72583106|NCT01422213|144696663|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.61|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001|TWO_SIDED|95.0|-0.81|-0.4||No adjustment for multiplicity was made.|Mixed Models Analysis|||Based on the FAS, the CGI-I Score was analysed using the MMRM with an unstructured covariance structure. The model included terms for grouped site and treatment-by-visit interaction.||-0.40|-0.81|<0.0001
72550117|NCT01822548|144630353|SUPERIORITY||Slope|0.362|||<|0.05|TWO_SIDED|95.0|0.028|0.695|||ANOVA|adjustment for baseline value of EPC||||0.695|0.028|<0.05
72550118|NCT01822548|144630354|SUPERIORITY||Slope|-0.067|||<|0.05|TWO_SIDED|95.0|-0.358|0.224|||ANOVA|||||0.224|-0.358|<0.05
72550119|NCT02545998|144630355|SUPERIORITY|||||||0.51|||||||Wilcoxon (Mann-Whitney)|||||||0.510
72550120|NCT02545998|144630356|SUPERIORITY|||||||0.014|||||||Wilcoxon (Mann-Whitney)|||||||0.014
72550121|NCT02545998|144630357|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
72550122|NCT02545998|144630358|SUPERIORITY|||||||0.589|||||||Wilcoxon (Mann-Whitney)|||||||0.589
72550123|NCT02545998|144630359|SUPERIORITY|||||||0.471|||||||Wilcoxon (Mann-Whitney)|||||||0.471
72550124|NCT02545998|144630360|SUPERIORITY|||||||0.264|||||||Sign test|||||||0.264
72550125|NCT04567342|144630363|SUPERIORITY||Risk Ratio (RR)|1.08||||0.531|TWO_SIDED|95.0|0.85|1.37|||Regression, Logistic||||Arm 3 vs. Arm 1|1.37|0.85|0.531
72550126|NCT04567342|144630363|SUPERIORITY||Risk Ratio (RR)|0.84||||0.189|TWO_SIDED|95.0|0.65|1.09|||Regression, Logistic||||Arm 2 vs. Arm 1|1.09|0.65|0.189
72550127|NCT04567342|144630363|SUPERIORITY||Risk Ratio (RR)|1.29||||0.054|TWO_SIDED|95.0|0.1|1.66|||Regression, Logistic||||Arm 3 vs. Arm 2|1.66|0.10|0.054
72550128|NCT04567342|144630363|SUPERIORITY||Risk Ratio (RR)|1.05||||0.654|TWO_SIDED|95.0|0.84|1.32|||Regression, Logistic||||Arm 4 vs. Arm 3|1.32|0.84|0.654
72550129|NCT04567342|144630363|SUPERIORITY||Risk Ratio (RR)|1.36||||0.018|TWO_SIDED|95.0|1.05|1.74|||Regression, Logistic||||Arm 4 vs. Arm 2|1.74|1.05|0.018
72550130|NCT04567342|144630363|SUPERIORITY||Risk Ratio (RR)|1.14||||0.283|TWO_SIDED|95.0|0.9|1.44|||Regression, Logistic||||Arm 4 vs. Arm 1|1.44|0.90|0.283
72550131|NCT04567342|144630364|SUPERIORITY||Risk Ratio (RR)|1.93|||<|0.01|TWO_SIDED|95.0|1.42|2.62|||Regression, Logistic||||Arm 3 vs. Arm 1|2.62|1.42|<0.01
72550132|NCT04567342|144630364|SUPERIORITY||Risk Ratio (RR)|0.82||||0.318|TWO_SIDED|95.0|0.56|1.21|||Regression, Logistic||||Arm 2 vs. Arm 1|1.21|0.56|0.318
72550133|NCT04567342|144630364|SUPERIORITY||Risk Ratio (RR)|2.34|||<|0.01|TWO_SIDED|95.0|1.68|3.26|||Regression, Logistic||||Arm 3 vs. Arm 2|3.26|1.68|<0.01
72550134|NCT04567342|144630364|SUPERIORITY||Risk Ratio (RR)|1.08||||0.535|TWO_SIDED|95.0|0.85|1.36|||Regression, Logistic||||Arm 4 vs. Arm 3|1.36|0.85|0.535
72550135|NCT04567342|144630364|SUPERIORITY||Risk Ratio (RR)|2.52|||<|0.01|TWO_SIDED|95.0|1.82|3.5|||Regression, Logistic||||Arm 4 vs Arm 2|3.50|1.82|<0.01
72550136|NCT04567342|144630364|SUPERIORITY||Risk Ratio (RR)|2.07|||<|0.01|TWO_SIDED|95.0|1.53|2.8|||Regression, Logistic||||Arm 4 vs. Arm 1|2.80|1.53|<0.01
72550137|NCT04567342|144630365|SUPERIORITY||Risk Ratio (RR)|1.17||||0.192|TWO_SIDED|95.0|0.92|1.48|||Regression, Logistic||||Arm 3 vs. Arm 1|1.48|0.92|0.192
72550138|NCT04567342|144630365|SUPERIORITY||Risk Ratio (RR)|0.81||||0.132|TWO_SIDED|95.0|0.62|1.06|||Regression, Logistic||||Arm 2 vs. Arm 1|1.06|0.62|0.132
72550139|NCT04567342|144630365|SUPERIORITY||Risk Ratio (RR)|1.44|||<|0.01|TWO_SIDED|95.0|1.11|1.86|||Regression, Logistic||||Arm 3 vs. Arm 2|1.86|1.11|<0.01
72550140|NCT04567342|144630365|SUPERIORITY||Risk Ratio (RR)|0.92||||0.462|TWO_SIDED|95.0|0.73|1.16|||Regression, Logistic||||Arm 4 vs. Arm 3|1.16|0.73|0.462
72550141|NCT04567342|144630365|SUPERIORITY||Risk Ratio (RR)|1.32||||0.039|TWO_SIDED|95.0|1.01|1.72|||Regression, Logistic||||Arm 4 vs. Arm 2|1.72|1.01|0.039
72550142|NCT04567342|144630365|SUPERIORITY||Risk Ratio (RR)|1.07||||0.57|TWO_SIDED|95.0|0.84|1.37|||Regression, Logistic||||Arm 4 vs. Arm 1|1.37|0.84|0.570
72550143|NCT01054599|144630366|OTHER||||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||||||>0.05
72550144|NCT01054599|144630369|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||||||>0.05
72550145|NCT04025879|144630387|SUPERIORITY||Cox Proportional Hazard|0.58||||0.00025|TWO_SIDED|95.0|0.43|0.78|||Log Rank||Stratified by randomization stratification factors: PD-L1 Status (\>=1% vs \<1%/not evaluable/indeterminate), disease stage (II vs III), histology (squamous vs non-squamous).|||0.78|0.43|0.00025
72550146|NCT04025879|144630389|SUPERIORITY||DIFFERENCE OF PCR|20.5|||||TWO_SIDED|95.0|14.3|26.6|||||Strata adjusted difference based on Cochran-Mantel-Haenszel (CMH) method of weighting.|||26.6|14.3|
72550147|NCT04025879|144630389|SUPERIORITY||Odds Ratio (OR)|6.64|||||TWO_SIDED|95.0|3.4|12.97|||||Strata adjusted odds ratio using Mantel-Haenszel method.|||12.97|3.40|
72550148|NCT04025879|144630390|SUPERIORITY||DIFFERENCE OF MPR|23.2|||||TWO_SIDED|95.0|15.8|30.6|||||Strata adjusted difference based on Cochran-Mantel-Haenszel (CMH) method of weighting.|||30.6|15.8|
72550149|NCT04025879|144630390|SUPERIORITY||Odds Ratio (OR)|4.01||||||95.0|2.48|6.49|||||Strata adjusted odds ratio using Mantel-Haenszel method.|||6.49|2.48|
72550150|NCT02999178|144630426|SUPERIORITY||Adjusted mean difference|106.96|STANDARD_ERROR_OF_MEAN|21.15|<|0.0001|TWO_SIDED|95.0|65.42|148.5||Treatment comparison of slopes was assessed through the treatment-by-time interaction coefficient. P-value was not adjusted for multiple comparisons.|Mixed Models Analysis|"Fixed effects: Treatment, HRCT fibrotic pattern, baseline FVC (mL), treatment-by-time, baseline-by-time interactions.~Random effects: time, intercept."|Difference of adjusted annual rates of decline was calculated as Nintedanib - Placebo.|The decrease in FVC was assumed to be linear within each participant over 52 weeks. The intercepts and slopes were assumed to be normally distributed with unstructured covariance matrix. The within participant error was assumed to be independent and normally distributed with mean 0 and a common variance. The Kenward-Roger approximation was used to estimate denominator degrees of freedom and adjust standard errors (SEs).||148.50|65.42|<.0001
72550151|NCT02999178|144630427|SUPERIORITY||Adjusted mean difference|128.2|STANDARD_ERROR_OF_MEAN|29.17|<|0.0001|TWO_SIDED|95.0|70.81|185.59||Treatment comparison of slopes was assessed through the treatment-by-time interaction coefficient. P-value was not adjusted for multiple comparisons.|Mixed Models Analysis|Fixed effects: Treatment, baseline FVC (mL), treatment-by-time, baseline-by-time interactions. Random effects: time, intercept.|Difference of adjusted annual rates of decline was calculated as Nintedanib - Placebo.|The decrease in FVC was assumed to be linear within each participant over 52 weeks. The intercepts and slopes were assumed to be normally distributed with unstructured covariance matrix. The within participant error was assumed to be independent and normally distributed with mean 0 and a common variance. The Kenward-Roger approximation was used to estimate denominator degrees of freedom and adjust standard errors (SEs).||185.59|70.81|<.0001
72412805|NCT02417246|144333696|EQUIVALENCE|A mixed effect model for repeated measures was performed to model the 24-hour ambulatory DBP by quartile for 35 patients receiving brand name metoprolol ER and Generic A.|Slope|-2.329||||0.068|TWO_SIDED||||||Mixed Models Analysis|||||||0.068
72583107|NCT01422213|144696663|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.86|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001|TWO_SIDED|95.0|-1.06|-0.65||No adjustment for multiplicity was made.|Mixed Models Analysis|||Based on the FAS, the CGI-I Score was analysed using the MMRM with an unstructured covariance structure. The model included terms for grouped site and treatment-by-visit interaction.||-0.65|-1.06|<0.0001
72583108|NCT01422213|144696664|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.19||||0.0002|TWO_SIDED|95.0|1.44|3.33||Wald's Test. No adjustment for multiplicity was made.|Regression, Logistic|||||3.33|1.44|0.0002
72583109|NCT01422213|144696664|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.43|||<|0.0001|TWO_SIDED|95.0|2.26|5.21||Wald's Test. No adjustment for multiplicity was made.|Regression, Logistic|||||5.21|2.26|<0.0001
72583110|NCT01422213|144696665|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.09||||0.003|TWO_SIDED|95.0|1.29|3.41||Wald's Test. No adjustment for multiplicity was made.|Regression, Logistic|||||3.41|1.29|0.0030
72583111|NCT01422213|144696665|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.13|||<|0.0001|TWO_SIDED|95.0|1.95|5.03||Wald's Test. No adjustment for multiplicity was made.|Regression, Logistic|||||5.03|1.95|<0.0001
72583112|NCT01422213|144696666|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.12|STANDARD_ERROR_OF_MEAN|0.059||0.0393|TWO_SIDED|95.0|0.01|0.24||No adjustment for multiplicity was made.|ANCOVA|||||0.24|0.01|0.0393
72583113|NCT01422213|144696667|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.23|STANDARD_ERROR_OF_MEAN|0.068||0.0007|TWO_SIDED|95.0|0.1|0.36||No adjustment for multiplicity was made.|ANCOVA|||||0.36|0.10|0.0007
72583114|NCT01422213|144696667|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.15|STANDARD_ERROR_OF_MEAN|0.068||0.0246|TWO_SIDED|95.0|0.02|0.29||No adjustment for multiplicity was made.|ANCOVA|||||0.29|0.02|0.0246
72583115|NCT02857816|144696682|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||This is a single arm study. The primary objective was to demonstrate a statistically significant reduction between baseline and following the 12th PTNM therapy sessions in the number of UUI episodes per day.||||<0.0001
72583116|NCT03197389|144696685|OTHER||Median Difference (Net)|0.0|||||TWO_SIDED|||||||||||||
72583117|NCT04129125|144696686|OTHER|The study sample size of 260 subjects was selected to have at least 90 percent power for primary safety and efficacy endpoints and all-cause mortality|Event rate|83.4|||<|0.0001|TWO_SIDED|95.0|78.0|88.0||The p-value a priori threshold for statistical significance was \<0.025|Fisher Exact|||The FDA agreed performance goal for the primary efficacy endpoint was for the lower bound of the two-sided 95% CI to be \>69%||88|78|<0.0001
72583118|NCT04129125|144696687|OTHER|The study sample size of 260 subjects was selected to have at least 90 percent power for primary safety and efficacy endpoints and all-cause mortality|Event rate|1.9|||||TWO_SIDED|95.0|0.6|4.4||||||The FDA agreed performance goal for the primary safety endpoint was for the observed rate to be ≤6.0%||4.4|0.6|
72583119|NCT04129125|144696688|OTHER|The study sample size of 260 subjects was selected to have at least 90 percent power for primary safety and efficacy endpoints and all-cause mortality|Event rate|84.0||||0.0001|TWO_SIDED|95.0|78.0|89.0||The p-value a priori threshold for statistical significance was \<0.025|Fisher Exact|||The FDA agreed performance goal for the primary efficacy endpoint was for the lower bound of the two-sided 95% CI to be \>69%||89|78|0.0001
72412806|NCT02417246|144333697|EQUIVALENCE|A mixed effect model for repeated measures was performed to model the 24-hour HR by quartile for 35 patients receiving brand name metoprolol ER and Generic B.|Slope|1.233||||0.333|TWO_SIDED||||||Mixed Models Analysis|||||||0.333
72412807|NCT02417246|144333697|EQUIVALENCE|A mixed effect model for repeated measures was performed to model the 24-hour HR by quartile for 35 patients receiving brand name metoprolol ER and Generic A.|Slope|1.134||||0.368|TWO_SIDED||||||Mixed Models Analysis|||||||0.368
72583120|NCT04129125|144696689|OTHER|The study sample size of 260 subjects was selected to have at least 90 percent power for primary safety and efficacy endpoints and all-cause mortality|Event rate|0.9|||||TWO_SIDED|95.0|0.1|3.4||||||The FDA agreed performance goal for the primary safety endpoint was for the observed rate to be ≤6.0%||3.4|0.1|
72583121|NCT04129125|144696698|OTHER|The study sample size of 260 subjects was selected to have at least 90 percent power for primary safety and efficacy endpoints and all-cause mortality|Event rate|12.7|||||TWO_SIDED|95.0|8.5|16.7|||||Event and CI estimated using Kaplan-Meier method|The FDA agreed performance goal for the all-cause mortality endpoint was for the observed rate to be ≤20.3%||16.7|8.5|
72583122|NCT04129125|144696709|OTHER|The study sample size of 260 subjects was selected to have at least 90 percent power for primary safety and efficacy endpoints and all-cause mortality|Event rate|12.3|||||TWO_SIDED|95.0|8.1|17.2|||||Event and CI estimated using Kaplan-Meier method|The FDA agreed performance goal for the primary safety endpoint was for the observed rate to be ≤20.3%||17.2|8.1|
72583123|NCT02723344|144696855|OTHER|||||||0.056|||||||Wilcoxon-rank sum|||||||.056
72583124|NCT02723344|144696856|OTHER|||||||0.26||||||Wilcoxon Rank-Sum|Wilcoxon (Mann-Whitney)|||||||.26
72583125|NCT02723344|144696858|OTHER|||||||0.64|||||||Wilcoxon Rank-Sum|||||||.64
72583126|NCT03473184|144696863|OTHER|p-values are from an ANOVA of the average numerical score (sum of erythema and edema) at 24 and 48 hours post irradiation (Days 3 and 4) with effects of subject and treatment, using Fisher's least significant differences.||||||1|||||||ANOVA|||Irradiated vehicle and untreated irradiated sites versus irradiated diacerein site, and non-irradiated vehicle site versus non-irradiated diacerein site and untreated irradiated site versus irradiated vehicle site.||||1.0000
72583127|NCT03473184|144696863|OTHER|p-values are from an ANOVA of the average numerical score (sum of erythema and edema) at 24 and 48 hours post irradiation (Days 3 and 4) with effects of subject and treatment, using Fisher's least significant differences.||||||0.0008|||||||ANOVA|||Non-irradiated diacerein and vehicle sites versus irradiated diacerein site, and irradiated vehicle and untreated irradiated sites versus non-irradiated diacerein site, and non-irradiated vehicle site versus irradiated vehicle site, and untreated irradiated site versus non-irradiated vehicle site.||||0.0008
72583128|NCT02964247|144696864|SUPERIORITY||Treatment difference|-0.68|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.89|-0.48|||pattern mixture model||Liraglutide - Placebo|Statistical analysis for the primary estimand. Primary estimand: treatment effect (effectiveness) based on the FAS using week 26 measurements from the in-trial observation period. The change in HbA1c from baseline to week 26 were analysed using a pattern mixture model with multiple imputation to impute missing data, with treatment, country and the stratification factor (metformin use at baseline: yes vs. no) as categorical fixed effects and baseline HbA1c as covariate.||-0.48|-0.89|<.001
72583129|NCT02964247|144696864|SUPERIORITY|Test was not controlled for type I error. Secondary estimand: treatment effect (efficacy) based on the FAS using post baseline measurements up to and including week 26 from the on-treatment without rescue medication obs. period.|Treatment difference|-0.74|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.94|-0.53|||Mixed Models Analysis||Liraglutide - Placebo|Statistical analysis for the secondary estimand.The change in HbA1c from baseline up to and including week 26 at scheduled time points were analysed using MMRM with treatment, country and the stratification factor (metformin use at baseline: yes vs. no) as categorical fixed effects and baseline HbA1c as covariate, all nested within visit.||-0.53|-0.94|<.001
72412808|NCT01614210|144333712|OTHER||percentage decrease in Ki67 after 7 days|||||0.0001|||||||t-test, 1 sided|||||||0.0001
72550152|NCT02999178|144630428|OTHER|No formal hypotheses were tested.|Adjusted mean difference|1.34|STANDARD_ERROR_OF_MEAN|0.84||0.1115|TWO_SIDED|95.0|-0.31|2.98|||Mixed Model Repeated Measures (MMRM)|Fixed effects: baseline K-BILD Total score, visit, treatment-by-visit and baseline-by-visit interactions, random effect: participant.|Adjusted mean difference was calculated as Nintedanib - Placebo.|||2.98|-0.31|0.1115
72550153|NCT02999178|144630429|OTHER|No formal hypotheses were tested.|Adjusted mean difference|1.53|STANDARD_ERROR_OF_MEAN|1.12||0.1747|TWO_SIDED|95.0|-0.68|3.74|||Mixed Model Repeated Measures (MMRM)|Fixed effects: baseline K-BILD Total score, visit, treatment-by-visit and baseline-by-visit interactions, random effect: participant.|Adjusted mean difference was calculated as Nintedanib - Placebo.|||3.74|-0.68|0.1747
72550154|NCT02999178|144630430|OTHER|No formal hypotheses were tested.|Hazard Ratio (HR)|0.8||||0.3948|TWO_SIDED|95.0|0.48|1.34|||Log Rank|Stratified by HRCT fibrotic pattern.|A Cox proportional hazards model, stratified by HRCT fibrotic pattern, was used to estimate the hazard ratio calculated as Nintedanib divided by Placebo.|||1.34|0.48|0.3948
72550155|NCT02999178|144630431|OTHER|No formal hypotheses were tested.|Hazard Ratio (HR)|0.67||||0.1985|TWO_SIDED|95.0|0.36|1.24|||Log Rank||A Cox proportional hazards model was used to estimate the hazard ratio calculated as Nintedanib divided by Placebo.|||1.24|0.36|0.1985
72550156|NCT02999178|144630432|OTHER|No formal hypotheses were tested.|Hazard Ratio (HR)|0.94||||0.8544|TWO_SIDED|95.0|0.47|1.86|||Log Rank|Stratified by HRCT fibrotic pattern.|A Cox proportional hazards model, stratified by HRCT fibrotic pattern, was used to estimate the hazard ratio calculated as Nintedanib divided by Placebo.|||1.86|0.47|0.8544
72550157|NCT02999178|144630433|OTHER|No formal hypotheses were tested.|Hazard Ratio (HR)|0.68||||0.3291|TWO_SIDED|95.0|0.32|1.47|||Log Rank||A Cox proportional hazards model was used to estimate the hazard ratio calculated as Nintedanib divided by Placebo.|||1.47|0.32|0.3291
72550158|NCT02999178|144630436|OTHER|No formal hypotheses were tested.|Hazard Ratio (HR)|0.65||||0.0017|TWO_SIDED|95.0|0.49|0.85|||Log Rank|Stratified by HRCT fibrotic pattern.|A Cox proportional hazards model, stratified by HRCT fibrotic pattern, was used to estimate the hazard ratio calculated as Nintedanib divided by Placebo.|||0.85|0.49|0.0017
72550159|NCT02999178|144630437|OTHER|No formal hypotheses were tested.|Hazard Ratio (HR)|0.64||||0.0081|TWO_SIDED|95.0|0.45|0.89|||Log Rank||A Cox proportional hazards model was used to estimate the hazard ratio calculated as Nintedanib divided by Placebo.|||0.89|0.45|0.0081
72550160|NCT02999178|144630438|OTHER|No formal hypotheses were tested.|Adjusted Odds Ratio|0.7|||||TWO_SIDED|95.0|0.52|0.96|||Regression, Logistic|Logistic regression model with continuous covariate baseline FVC % pred and binary covariate HRCT fibrotic pattern.|Ratio calculated as Nintedanib divided by Placebo.|||0.96|0.52|
72550161|NCT02999178|144630439|OTHER|No formal hypotheses were tested.|Adjusted Odds Ratio|0.63|||||TWO_SIDED|95.0|0.43|0.94|||Regression, Logistic|Logistic regression model with continuous covariate baseline FVC % pred.|Ratio calculated as Nintedanib divided by Placebo.|||0.94|0.43|
72583130|NCT02964247|144696865|SUPERIORITY||Treatment difference|-0.82|STANDARD_ERROR_OF_MEAN|0.46||0.077|TWO_SIDED|95.0|-1.73|0.09|||pattern mixture model||Liraglutide - Placebo|Statistical analysis for the primary estimand. Primary estimand: treatment effect (effectiveness) based on the FAS using week 26 measurements from the in-trial observation period. The change in body weight from baseline to week 26 were analysed using a pattern mixture model with multiple imputation to impute missing data, with treatment, country and the stratification factor (metformin use at baseline: yes vs. no) as categorical fixed effects and baseline body weight as covariate.||0.09|-1.73|0.077
72550162|NCT02999178|144630440|OTHER|No formal hypotheses were tested.|Adjusted Odds Ratio|0.5|||||TWO_SIDED|95.0|0.36|0.68|||Regression, Logistic|Logistic regression model with continuous covariate baseline FVC % pred and binary covariate HRCT fibrotic pattern.|Ratio calculated as Nintedanib divided by Placebo.|||0.68|0.36|
72550163|NCT02999178|144630441|OTHER|No formal hypotheses were tested.|Adjusted Odds Ratio|0.46|||||TWO_SIDED|95.0|0.31|0.69|||Regression, Logistic|Logistic regression model with continuous covariate baseline FVC % pred.|Ratio calculated as Nintedanib divided by Placebo.|||0.69|0.31|
72550164|NCT02999178|144630442|OTHER|No formal hypotheses were tested.|Adjusted mean difference|-3.53|STANDARD_ERROR_OF_MEAN|1.33|||TWO_SIDED|95.0|-6.14|-0.92|||Mixed Model Repeated Measures|Fixed effects: baseline, HRCT fibrotic pattern, visit, treatment-by-visit interaction, baseline-by-visit interaction, random effect: participant.|Adjusted mean difference was calculated as Nintedanib - Placebo.|||-0.92|-6.14|
72550165|NCT02999178|144630443|OTHER|No formal hypotheses were tested.|Adjusted mean difference|-4.18|STANDARD_ERROR_OF_MEAN|1.68|||TWO_SIDED|95.0|-7.48|-0.88|||Mixed Model Repeated Measures|Fixed effects: baseline, visit, treatment-by-visit interaction, baseline-by-visit interaction, random effect: participant.|Adjusted mean difference was calculated as Nintedanib - Placebo.|||-0.88|-7.48|
72550166|NCT02999178|144630444|OTHER|No formal hypotheses were tested.|Adjusted mean difference|-6.09|STANDARD_ERROR_OF_MEAN|1.81|||TWO_SIDED|95.0|-9.65|-2.53|||Mixed Model Repeated Measures|Fixed effects: baseline, HRCT fibrotic pattern, visit, treatment-by-visit interaction, baseline-by-visit interaction, random effect: participant.|Adjusted mean difference was calculated as Nintedanib - Placebo.|||-2.53|-9.65|
72550167|NCT02999178|144630445|OTHER|No formal hypotheses were tested.|Adjusted mean difference|-7.28|STANDARD_ERROR_OF_MEAN|2.33|||TWO_SIDED|95.0|-11.86|-2.71|||Mixed Model Repeated Measures|Fixed effects: baseline, visit, treatment-by-visit interaction, baseline-by-visit interaction, random effect: participant.|Adjusted mean difference was calculated as Nintedanib - Placebo.|||-2.71|-11.86|
72550168|NCT00090857|144630446|SUPERIORITY_OR_OTHER|||||||0.15|||||||Wilcoxon (Mann-Whitney)|||Sample size for a detectable difference in the within participant change in bone density between arms was calculated using standard deviations of one year change in bone density. Control estimates were 2.8% for spine and 3.85% for femoral neck. With 100 patients and 2:1 randomization (67 letrozole: 33 placebo), using a 1-sided Wilcoxon rank sum test with size 0.05, there is 80% power to detect as significant a true difference in change in the spine of 1.6% and in the femoral neck of 2.27%.||||0.15
72412809|NCT04321460|144333718|SUPERIORITY||Odds Ratio (OR)|4.564||||0.007|TWO_SIDED|95.0|1.66|16.039|||Wilcoxon (Mann-Whitney)|||||16.039|1.66|0.007
72412810|NCT04321460|144333719|SUPERIORITY||Odds Ratio (OR)|4.716||||0.002|TWO_SIDED|95.0|1.898|14.268|||Wilcoxon (Mann-Whitney)|||||14.268|1.898|0.002
72412811|NCT04495712|144333732|SUPERIORITY|||||||0.71|||||||Log Rank|||||||0.71
72550169|NCT00090857|144630447|SUPERIORITY_OR_OTHER|||||||0.7|||||||Wilcoxon (Mann-Whitney)|||Sample size for a detectable difference in the within participant change in bone density between arms was calculated using standard deviations of one year change in bone density. Control estimates were 2.8% for spine and 3.85% for femoral neck. With 100 patients and 2:1 randomization (67 letrozole: 33 placebo), using a 1-sided Wilcoxon rank sum test with size 0.05, there is 80% power to detect as significant a true difference in change in the spine of 1.6% and in the femoral neck of 2.27%.||||0.70
72550170|NCT00090857|144630448|SUPERIORITY_OR_OTHER|||||||0.03|||||||Wilcoxon (Mann-Whitney)|||Sample size for a detectable difference in the within participant change in bone density between arms was calculated using standard deviations of one year change in bone density. Control estimates were 2.8% for spine and 3.85% for femoral neck. With 100 patients and 2:1 randomization (67 letrozole: 33 placebo), using a 1-sided Wilcoxon rank sum test with size 0.05, there is 80% power to detect as significant a true difference in change in the spine of 1.6% and in the femoral neck of 2.27%.||||0.03
72550171|NCT00090857|144630449|SUPERIORITY_OR_OTHER|||||||0.06|||||||Wilcoxon (Mann-Whitney)|||Sample size for a detectable difference in the within participant change in bone density was calculated using standard deviations of one year change in bone density. Control estimates were 2.8% for spine and 3.85% for femoral neck. With 100 patients and 2:1 randomization (67 letrozole: 33 placebo), using a 1-sided Wilcoxon rank sum test with size 0.05, there is 80% power to detect as significant a true difference in change in the spine of 1.6% and in the femoral neck of 2.27%.||||0.06
72550172|NCT00090857|144630450|SUPERIORITY_OR_OTHER|||||||0.38|||||||Fisher Exact|||||||0.38
72550173|NCT00090857|144630451|SUPERIORITY_OR_OTHER|||||||0.02|||||||Fisher Exact|||||||0.02
72550174|NCT00090857|144630452|SUPERIORITY_OR_OTHER|||||||0.2|||||||Fisher Exact|||||||0.20
72550175|NCT00090857|144630453|SUPERIORITY_OR_OTHER|||||||0.88|||||||Fisher Exact|||||||.88
72583131|NCT02964247|144696865|SUPERIORITY|Test was not controlled for type I error. Secondary estimand: treatment effect (efficacy) based on the FAS using post baseline measurements up to and including week 26 from the on-treatment without rescue medication obs. period.|Treatment difference|-0.86|STANDARD_ERROR_OF_MEAN|0.46||0.062|TWO_SIDED|95.0|-1.77|0.04|||Mixed Models Analysis||Liraglutide - Placebo|Statistical analysis for the secondary estimand. The change in body weight from baseline up to and including week 26 at scheduled time points were analysed using MMRM with treatment, country and the stratification factor (metformin use at baseline: yes vs. no) as categorical fixed effects and baseline body weight as covariate, all nested within visit.||0.04|-1.77|0.062
72583132|NCT01709500|144696890|SUPERIORITY_OR_OTHER||LS Mean Difference|-51.4|||<|0.0001|TWO_SIDED|95.0|-58.1|-44.8||Threshold for significance ≤ 0.05.|Mixed Models Analysis|||Alirocumab group was compared to the placebo group using an appropriate contrast statement.||-44.8|-58.1|<0.0001
72583133|NCT01709500|144696891|SUPERIORITY_OR_OTHER||LS Mean Difference|-52.2|||<|0.0001|TWO_SIDED|95.0|-58.7|-45.6||Threshold for significance ≤ 0.05.|Mixed Models Analysis|||A hierarchical testing procedure was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when previous endpoint was statistically significant at 5% level.||-45.6|-58.7|<0.0001
72583134|NCT01709500|144696892|SUPERIORITY_OR_OTHER||LS Mean Difference|-48.4|||<|0.0001|TWO_SIDED|95.0|-54.7|-42.2||Threshold for significance ≤ 0.05.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).||-42.2|-54.7|<0.0001
72550176|NCT00090857|144630454|SUPERIORITY_OR_OTHER|||||||0.27|||||||Fisher Exact|||||||0.27
72550177|NCT00090857|144630455|SUPERIORITY_OR_OTHER|||||||0.6|||||||Fisher Exact|||||||.60
72550178|NCT00090857|144630456|SUPERIORITY_OR_OTHER|||||||0.58|||||||Fisher Exact|||||||.58
72550179|NCT00090857|144630457|SUPERIORITY_OR_OTHER|||||||0.49|||||||Fisher Exact|||||||.49
72550180|NCT05097326|144630458|OTHER|||||||0.44||||||a p-value \<0.05 would be considered statistically significant|Fisher Exact|||Analysis of total contractions||||0.44
72550181|NCT05097326|144630458|OTHER|||||||0.02||||||a p-value of \<0.05 would be considered statistically significant|Fisher Exact|||Analysis of contractions per hour||||0.02
72412812|NCT04495712|144333733|SUPERIORITY|||||||0.07|||||||Log Rank|||||||0.07
72412813|NCT04495712|144333734|SUPERIORITY|||||||0.42|||||||t-test, 2 sided|||||||0.42
72412814|NCT02162810|144333738|OTHER||||||<|0.62|||||||Fisher Exact|||Due to the number of 0 cell counts, it is not possible to do individual statistics for each complication, so we looked at the incidence of complications overall between the two arms.||||<.62
72550182|NCT05097326|144630459|OTHER|||||||0.04||||||a p-value of \<0.05 would be considered statistically significant|Fisher Exact|||Comparison at 12 hours after labor induction||||0.04
72412815|NCT02162810|144333739|OTHER||||||<|0.61|||||||Fisher Exact|||||||<0.61
72550183|NCT05097326|144630459|OTHER|||||||0.17||||||a p-value of \<0.05 would be considered statistically significant|Fisher Exact|||Comparison of uterine tachysystole of total labor duration||||0.17
72550184|NCT05097326|144630460|OTHER|||||||0.63||||||a p-value \<0.05 would be considered statistically significant|Wilcoxon (Mann-Whitney)|||||||0.63
72550185|NCT05097326|144630461|OTHER|||||||0.01||||||a p-value of \<0.05 would be considered statistically significant|Wilcoxon (Mann-Whitney)|||||||0.01
72550186|NCT05097326|144630462|OTHER|||||||0.04||||||a p-value of \<0.05 would be considered statistically significant|Wilcoxon (Mann-Whitney)|||Comparison at complete cervical dilation||||0.04
72550187|NCT05097326|144630463|OTHER|||||||0.04||||||a p-value of \<0.05 would be considered statistically significant|Wilcoxon (Mann-Whitney)|||Comparison at postpartum transfer||||0.04
72550188|NCT05097326|144630464|OTHER|||||||0.68||||||a p-value of \<0.05 would be considered statistically significant|Fisher Exact|||||||0.68
72550189|NCT05097326|144630465|OTHER|||||||1||||||A p-value of \<0.05 would be considered significant.|Fisher Exact|||||||1
72550190|NCT05097326|144630466|OTHER|||||||1||||||a p-value of \<0.05 would be considered statistically significant|Fisher Exact|||||||1
72550191|NCT05097326|144630467|OTHER|||||||0.9||||||A p-value \<0.05 would be considered statistically significant|Wilcoxon (Mann-Whitney)|||||||0.90
72550192|NCT05097326|144630468|OTHER|||||||0.17||||||a p-value \<0.05 would be considered statistically significant|Fisher Exact|||1 minute APGAR score||||0.17
72550193|NCT05097326|144630468|OTHER|||||||1||||||A p-value of \<0.05 would be statistically significant.|Fisher Exact|||APGAR score at 5 minutes||||1
72550194|NCT05097326|144630469|OTHER|||||||0.22||||||A p-value of \<0.05 would be considered statistically significant|Fisher Exact|||||||0.22
72550195|NCT03480425|144630471|SUPERIORITY||Mean Difference (Final Values)|0.12|STANDARD_DEVIATION|4.4|<|0.05|TWO_SIDED|95.0|-2.4|2.6|||t-test, 2 sided|||||2.6|-2.4|<0.05
72550196|NCT02424188|144630477|SUPERIORITY||Odds Ratio (OR)|5.9|||||TWO_SIDED|95.0|2.3|15.4||||||||15.4|2.3|
72550197|NCT02424188|144630478|SUPERIORITY||Odds Ratio (OR)|3.9|||||TWO_SIDED|95.0|1.2|12.3||||||||12.3|1.2|
72550198|NCT02424188|144630479|SUPERIORITY||Odds Ratio (OR)|4.8|||||TWO_SIDED|95.0|1.3|17.5||||||6 month comparison||17.5|1.3|
72550199|NCT02424188|144630479|SUPERIORITY||Odds Ratio (OR)|10.8|||||TWO_SIDED|95.0|2.4|48.6||||||12 month||48.6|2.4|
72550200|NCT02424188|144630481|SUPERIORITY||Mean Difference (Net)|0.3|||||TWO_SIDED|95.0|-1.7|2.3||||||6 months||2.3|-1.7|
72550201|NCT02424188|144630481|SUPERIORITY||Mean Difference (Net)|1.6|||||TWO_SIDED|95.0|-1.5|4.7||||||18 months||4.7|-1.5|
72550202|NCT02424188|144630482|SUPERIORITY||Mean Difference (Net)|0.4|||||TWO_SIDED|95.0|-0.6|1.5||||||||1.5|-0.6|
72550203|NCT02424188|144630484|SUPERIORITY||Mean Difference (Net)|-16.2|||||TWO_SIDED|95.0|-30.2|-2.3||||||||-2.3|-30.2|
72550204|NCT02086188|144630492|SUPERIORITY|||||||0.1911|||||||ANCOVA|||||||0.1911
72550205|NCT02086188|144630493|SUPERIORITY|||||||0.4271|||||||ANCOVA|||||||0.4271
72550206|NCT02086188|144630494|SUPERIORITY|||||||0.1723|||||||ANCOVA|||||||0.1723
72550207|NCT02086188|144630495|SUPERIORITY|||||||0.634|||||||ANCOVA|||||||0.6340
72550208|NCT02086188|144630496|SUPERIORITY|||||||0.0091|||||||ANCOVA|||||||0.0091
72550209|NCT02753842|144630502|SUPERIORITY||Mean Difference (Final Values)|1.39|||<|0.05|TWO_SIDED|95.0|0.52|2.26||The a priori threshold was p\<0.05.|Mixed Models Analysis|||Comparing fitted to standard condoms, the null hypothesis was no difference in pleasure.||2.26|0.52|<0.05
72583135|NCT01709500|144696893|SUPERIORITY_OR_OTHER||LS Mean Difference|-48.8|||<|0.0001|TWO_SIDED|95.0|-55.0|-42.5||Threshold for significance ≤ 0.05.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).||-42.5|-55|<0.0001
72583136|NCT01709500|144696894|SUPERIORITY_OR_OTHER||LS Mean Difference|-39.3|||<|0.0001|TWO_SIDED|95.0|-44.1|-34.5||Threshold for significance ≤ 0.05.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).||-34.5|-44.1|<0.0001
72583137|NCT01709500|144696895|SUPERIORITY_OR_OTHER||LS Mean Difference|-39.8|||<|0.0001|TWO_SIDED|95.0|-44.5|-35.1||Threshold for significance ≤ 0.05.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).||-35.1|-44.5|<0.0001
72412816|NCT02162810|144333740|OTHER||||||<|0.87|||||||Fisher Exact|||Improvement category: Chordee with Degloving||||<.87
72412817|NCT02162810|144333740|OTHER||||||<|0.64|||||||Fisher Exact|||Improvement category: Ventral Chordee||||<.64
72412818|NCT02162810|144333740|OTHER||||||<|0.85|||||||Fisher Exact|||Improvement category: Chordee with Plication||||<.85
72412819|NCT00706121|144333746|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.96||||0.96|TWO_SIDED|95.0|0.9|1.02|||Log binomial regression|||||1.02|0.9|0.96
72412820|NCT00706121|144333747|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.92||||0.32|TWO_SIDED|95.0|0.78|1.08|||Log binomial regression|||||1.08|0.78|0.32
72550210|NCT02753842|144630503|SUPERIORITY||Odds Ratio (OR)|1.13|||>|0.05|TWO_SIDED|95.0|0.92|1.38|||Mixed Models Analysis|||A single item assessed whether participants preferred fitted condoms or standard condoms at the end of the study (the item word viewed by participants used the blinded identifiers of each condom type).||1.38|0.92|>0.05
72550211|NCT02753842|144630505|SUPERIORITY||Odds Ratio (OR)|0.93|||>|0.05|TWO_SIDED|95.0|0.27|3.24|||logistic mixed effects model|||We assessed clinical condom failure for anal sex, comparing anal sex acts with fitted condoms to anal sex acts with standard condoms.||3.24|0.27|>0.05
72550212|NCT02753842|144630506|SUPERIORITY||Median Difference (Final Values)|1.06|||<|0.05|TWO_SIDED|95.0|0.18|1.94||The a priori threshold was p\<0.05.|Mixed Models Analysis|||Comparing thin to standard condoms, the null hypothesis was no difference in pleasure.||1.94|0.18|<0.05
72550213|NCT03471078|144630507|OTHER|The primary efficacy endpoint was tested between avatrombopag and placebo using the Cochran-Mantel-Haenszel 2-sided test at α=0.05, adjusting for the number of eligible chemotherapy agents as collected in IWRS (1 or ≥2 permissible chemotherapy agents).|Mean Difference (Final Values)|-3.0||||0.7186|TWO_SIDED|95.0|-21.7|15.6|||Cochran-Mantel-Haenszel|||||15.6|-21.7|0.7186
72550214|NCT03471078|144630508|OTHER|||||||0.8372|||||||Van Elteren Test|||||||0.8372
72550215|NCT00153803|144630526|SUPERIORITY||Hazard Ratio (HR)|0.93||||0.165|TWO_SIDED|95.0|0.65|1.33|||Log Rank|||||1.33|0.65|0.165
72550216|NCT00153803|144630527|SUPERIORITY||Hazard Ratio (HR)|1.18||||0.32|TWO_SIDED|95.0|0.85|1.63|||Log Rank|||||1.63|0.85|0.32
72583138|NCT01709500|144696896|SUPERIORITY_OR_OTHER||LS Mean Difference|-45.7|||<|0.0001|TWO_SIDED|95.0|-51.8|-39.7||Threshold for significance ≤ 0.05.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).||-39.7|-51.8|<0.0001
72583139|NCT01709500|144696897|SUPERIORITY_OR_OTHER||LS Mean Difference|-46.4|||<|0.0001|TWO_SIDED|95.0|-52.3|-40.4||Threshold for significance ≤ 0.05.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).||-40.4|-52.3|<0.0001
72583140|NCT01709500|144696898|SUPERIORITY_OR_OTHER||LS Mean difference|-32.8|||<|0.0001|TWO_SIDED|95.0|-37.4|-28.1||Threshold for significance ≤ 0.05.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).||-28.1|-37.4|<0.0001
72583141|NCT01709500|144696899|SUPERIORITY_OR_OTHER||LS Mean Difference|-34.5|||<|0.0001|TWO_SIDED|95.0|-39.2|-29.8||Threshold for significance ≤ 0.05.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).||-29.8|-39.2|<0.0001
72583142|NCT01709500|144696900|SUPERIORITY_OR_OTHER||LS Mean Difference|-42.0|||<|0.0001|TWO_SIDED|95.0|-47.8|-36.2||Threshold for significance ≤ 0.05.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).||-36.2|-47.8|<0.0001
72583143|NCT01709500|144696901|SUPERIORITY_OR_OTHER||LS Mean Difference|-29.9|||<|0.0001|TWO_SIDED|95.0|-34.5|-25.4|||Mixed Models Analysis|Threshold for significance ≤ 0.05.||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).||-25.4|-34.5|<0.0001
72583144|NCT01709500|144696902|SUPERIORITY_OR_OTHER||LS Mean Difference|-58.8|||<|0.0001|TWO_SIDED|95.0|-66.8|-50.8||Threshold for significance ≤ 0.05.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).||-50.8|-66.8|<0.0001
72583145|NCT01709500|144696903|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|52.2|||<|0.0001|TWO_SIDED|95.0|20.9|130.0||Threshold for significance ≤ 0.05.|Regression, Logistic|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant). Statistical analysis used a multiple imputation approach followed by a Logistic regression model.||130|20.9|<0.0001
72583146|NCT01709500|144696904|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|53.3|||<|0.0001|TWO_SIDED|95.0|21.4|132.6||Threshold for significance ≤ 0.05.|Regression, Logistic|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant). Statistical analysis used a multiple imputation approach followed by a Logistic regression model.||132.6|21.4|<0.0001
72583147|NCT01709500|144696905|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|239.7|||<|0.0001|TWO_SIDED|95.0|31.6|1820.3||Threshold for significance ≤ 0.05.|Regression, Logistic|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant). Statistical analysis used a multiple imputation approach followed by a Logistic regression model.||1820.3|31.6|<0.0001
72583148|NCT01709500|144696906|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|240.6|||<|0.0001|TWO_SIDED|95.0|31.4|1841.7||Threshold for significance ≤ 0.05.|Regression, Logistic|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant). Statistical analysis used a multiple imputation approach followed by a Logistic regression model.||1841.7|31.4|<0.0001
72583149|NCT01709500|144696907|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-20.3|||<|0.0001|TWO_SIDED|95.0|-26.4|-14.2||Threshold for significance ≤ 0.05.|Regression, Robust|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant). Statistical analysis used a multiple imputation approach followed by a robust regression model.||-14.2|-26.4|<0.0001
72583150|NCT01709500|144696908|SUPERIORITY_OR_OTHER||LS Mean Difference|6.8|||=|0.0009|TWO_SIDED|95.0|2.8|10.7||Threshold for significance ≤ 0.05.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).||10.7|2.8|= 0.0009
72583151|NCT01709500|144696909|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-10.9|||=|0.0012|TWO_SIDED|95.0|-17.5|-4.3||Threshold for significance ≤ 0.05.|Regression, Robust|||Testing according to the hierarchical testing procedure. Statistical analysis used a multiple imputation approach followed by a robust regression model.||-4.3|-17.5|= 0.0012
72583152|NCT01709500|144696910|SUPERIORITY_OR_OTHER||LS Mean Difference|4.4|||=|0.0062|TWO_SIDED|95.0|1.3|7.5||Threshold for significance ≤ 0.05.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).||7.5|1.3|= 0.0062
72583153|NCT01709500|144696911|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-19.1|||<|0.0001|TWO_SIDED|95.0|-25.0|-13.1||Threshold for significance ≤ 0.05.|Regression, Robust|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant). Statistical analysis used a multiple imputation approach followed by a robust regression model.||-13.1|-25|<0.0001
72412821|NCT00706121|144333749|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.91||||0.24|TWO_SIDED|95.0|0.77|1.07|||Log binomial regression|||||1.07|0.77|0.24
72412822|NCT00706121|144333750|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|1.03||||0.38|TWO_SIDED|95.0|0.96|1.1|||Log binomial regression|||||1.10|0.96|0.38
72412823|NCT01308749|144333755|OTHER||||||||||||||||||No analyses were completed, this is descriptive only and is an absolute value (number of participants).|||
72412824|NCT01308749|144333759|EQUIVALENCE|Within group test of difference using t-scores adjusted by baseline score, no correction for multiple comparisons, nonparametric model||||||0.023|||||||t-test, 2 sided|||||||0.023
72583154|NCT01709500|144696912|SUPERIORITY_OR_OTHER||LS Mean Difference|4.3|||=|0.0147|TWO_SIDED|95.0|0.9|7.8||Threshold for significance ≤ 0.05.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).||7.8|0.9|= 0.0147
72583155|NCT01709500|144696913|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-8.6|||=|0.024|TWO_SIDED|95.0|-16.1|-1.1||Threshold for significance ≤ 0.05.|Regression, Robust|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant). Statistical analysis used a multiple imputation approach followed by a robust regression model.||-1.1|-16.1|= 0.024
72583156|NCT01709500|144696914|SUPERIORITY_OR_OTHER||LS Mean Difference|2.3|||=|0.1475|TWO_SIDED|95.0|-0.8|5.5||Threshold for significance ≤ 0.05.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).||5.5|-0.8|= 0.1475
72583157|NCT05022667|144696920|SUPERIORITY|||||||0.3|||||||t-test, 2 sided|||||||0.3
72583158|NCT05022667|144696921|SUPERIORITY|||||||0.5|||||||t-test, 2 sided|||||||.5
72583159|NCT05022667|144696922|SUPERIORITY|||||||0.2|||||||t-test, 2 sided|||||||.2
72583160|NCT05022667|144696923|SUPERIORITY|||||||0.3|||||||t-test, 2 sided|||||||0.3
72583161|NCT05022667|144696924|SUPERIORITY|||||||0.4|||||||t-test, 2 sided|||||||.4
72583162|NCT05022667|144696926|SUPERIORITY|||||||0.3|||||||Chi-squared|||||||.3
72583163|NCT03103087|144696944|SUPERIORITY||Treatment Difference|56.47|||<|0.0001|TWO_SIDED|95.0|46.45|66.49||P-value was stratified by baseline MBL volume (\< 225 mL or ≥ 225 mL) and geographic region (North America or Rest of World). Assessed at a 2-sided α = 0.05 significance level.|Cochran-Mantel-Haenszel||Treatment difference is relugolix plus E2/NETA minus placebo.|||66.49|46.45|<0.0001
72583164|NCT03103087|144696945|SUPERIORITY||Treatment Difference|47.3|||<|0.0001|TWO_SIDED|95.0|38.04|56.56||P-value was based on Cochran-Mantel-Haenszel test stratified by Baseline MBL volume (\< 225 mL, ≥ 225 mL) and geographic region (North America or Rest of World). Assessed at a 2-sided α = 0.05 significance level.|Cochran-Mantel-Haenszel|Treatment difference was relugolix plus E2/NETA minus placebo. 95% confidence interval (CI) for the difference is based on the normal approximation.||||56.56|38.04|<0.0001
72583165|NCT03103087|144696946|SUPERIORITY||Treatment Difference|-69.2|STANDARD_ERROR_OF_MEAN|7.58|<|0.0001|TWO_SIDED|95.0|-84.1|-54.3||Treatment, visit, region, Baseline MBL and treatment by visit interaction included as fixed effects. Assessed at a 2-sided α = 0.05 significance.|Mixed Models Analysis||Treatment difference was relugolix plus E2/NETA minus placebo.|||-54.3|-84.1|<0.0001
72583166|NCT03103087|144696947|SUPERIORITY||Treatment Difference|55.88|||<|0.0001|TWO_SIDED|95.0|37.25|74.52||P-value is based on Cochran-Mantel-Haenszel test stratified by Baseline MBL volume (\< 225 mL, ≥ 225 mL). Assessed at a 2-sided α = 0.05 significance level.|Cochran-Mantel-Haenszel||Treatment difference is relugolix plus E2/NETA minus placebo. 95% CI for difference is based on the normal approximation.|||74.52|37.25|<0.0001
72583167|NCT03103087|144696948|SUPERIORITY||Treatment Difference|29.99|||<|0.0001|TWO_SIDED|95.0|15.6|44.38||P-value is based on Cochran-Mantel-Haenszel test stratified by Baseline MBL volume (\< 225 mL, ≥ 225 mL). Assessed at a 2-sided α = 0.05 significance level.|Cochran-Mantel-Haenszel||Treatment difference is relugolix plus E2/NETA minus placebo. 95% CI for difference is based on the normal approximation.|||44.38|15.6|<0.0001
72583168|NCT03103087|144696949|SUPERIORITY||Treatment Difference|-10.0|STANDARD_ERROR_OF_MEAN|8.03|=|0.2153|TWO_SIDED|95.0|-25.8|5.8||LS Means based on analysis of covariance model including treatment, randomization stratification factors, Baseline MBL volume (\< 225 mL, ≥ 225 mL) and geographic region (North America, Rest of World), and Baseline values as covariate.|ANCOVA|||||5.8|-25.8|=0.2153
72583169|NCT03103087|144696950|SUPERIORITY||Treatment Difference|-12.2|STANDARD_ERROR_OF_MEAN|4.57|=|0.0078|TWO_SIDED|95.0|-21.3|-3.2||LS Means based on analysis of covariance model including treatment, randomization stratification factors, Baseline MBL volume (\< 225 mL, ≥ 225 mL) and geographic region (North America, Rest of World), and Baseline values as covariate.|ANCOVA|||||-3.2|-21.3|=0.0078
72583170|NCT03103087|144696951|SUPERIORITY||Treatment Difference|-33.4|STANDARD_ERROR_OF_MEAN|3.98|<|0.0001|TWO_SIDED|95.0|-41.2|-25.5||Assessed at a 2-sided α = 0.05 significance level.|Mixed Models Analysis||Relugolix plus E2/NETA minus placebo. Treatment, visit, region, Baseline MBL and treatment by visit interaction as fixed effects.|||-25.5|-41.2|<0.0001
72583171|NCT03103087|144696954|OTHER||Risk Ratio (RR)|0.16|||<|0.0001|TWO_SIDED|95.0|0.07|0.33|||Fisher Exact|||||0.33|0.07|<0.0001
72550217|NCT01882647|144630531|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||"Treatment groups were compared with respect to the proportions of subjects with treatment success at Day 15 using the Cochran-Mantel-Haenszel (CMH) test stratified by analysis center."|Cochran-Mantel-Haenszel|Multiple imputation was used to impute missing data from the ITT population.||||||<0.001
72550218|NCT01882647|144630532|SUPERIORITY_OR_OTHER||||||<|0.001||||||The pre-specified threshold for statistical significance was ≤0.05.|Cochran-Mantel-Haenszel|Missing data was imputed as treatment failure.||Treatment groups were compared with respect to each of the clinical signs of psoriasis (scaling, erythema and plaque elevation).||||<0.001
72583172|NCT03103087|144696959|SUPERIORITY||||||<|0.0001||||||P-value is based on Log-rank test stratified by Baseline MBL volume (\< 225 mL, ≥ 225 mL) and geographic region (North America, Rest of World) from the proportional hazard regression model comparing relugolix plus E2/NETA with placebo.|Log Rank|||||||< 0.0001
72583173|NCT03103087|144696960|SUPERIORITY||||||<|0.0001||||||P-value for testing difference between relugolix plus E2/NETA and placebo is based on Cochran-Mantel-Haenszel test stratified by Baseline MBL volume (\< 225 mL, ≥ 225 mL) and geographic region (North America, Rest of World).|Cochran-Mantel-Haenszel|||||||<0.0001
72583174|NCT03103087|144696961|SUPERIORITY||||||<|0.0001||||||P-value is based on Log-rank test stratified by Baseline MBL volume (\< 225 mL, ≥ 225 mL) and geographic region (North America, Rest of World) from the proportional hazard regression model comparing relugolix plus E2/NETA with placebo.|Log Rank|||||||<0.0001
72583175|NCT03103087|144696962|SUPERIORITY||||||<|0.0001||||||P-value is based on Log-rank test stratified by Baseline MBL volume (\< 225 mL, ≥ 225 mL) and geographic region (North America, Rest of World) from the proportional hazard regression model comparing relugolix plus E2/NETA with placebo.|Log Rank|||||||< 0.0001
72583176|NCT03103087|144696963|SUPERIORITY||||||<|0.0001||||||P-value was based on Cochran-Mantel-Haenszel test stratified by Baseline MBL volume (\< 225 mL, ≥ 225 mL).|Cochran-Mantel-Haenszel|||||||<0.0001
72583177|NCT03103087|144696964|SUPERIORITY||||||<|0.0001||||||LS means and p-value for test of difference is relugolix plus E2/NETA minus Placebo based on mixed-effect model with treatment, visit, region, Baseline MBL and treatment by visit interaction included as fixed effects.|Mixed Models Analysis|||||||<0.0001
72583178|NCT03103087|144696965|SUPERIORITY||||||<|0.0001||||||P-value was based on Cochran-Mantel-Haenszel test stratified by Baseline MBL volume (\< 225 mL, ≥ 225 mL) and geographic region (North America, Rest of World). Lower limit of normal is Hgb \< 11.6 g/dL.|Cochran-Mantel-Haenszel|||||||<0.0001
72583179|NCT03103087|144696966|SUPERIORITY||||||<|0.0001||||||LS means and p-value for test of difference is relugolix plus E2/NETA minus placebo based on mixed-effect model with treatment, visit, region, Baseline MBL, and treatment by visit interaction included.|Mixed Models Analysis|||||||<0.0001
72583180|NCT03103087|144696967|SUPERIORITY||||||<|0.0001||||||LS means and p-value for test of difference is relugolix plus E2/NETA minus placebo based on mixed-effect model with treatment, visit, region, Baseline MBL, and treatment by visit interaction included as fixed effects.|Mixed Models Analysis|||||||<0.0001
72583181|NCT03103087|144696968|SUPERIORITY||||||<|0.0001||||||LS means and p-value for test of difference is relugolix plus E2/NETA minus placebo based on mixed-effect model with treatment, visit, region, Baseline MBL, and treatment by visit interaction included as fixed effects.|Mixed Models Analysis|||||||<0.0001
72412825|NCT01308749|144333761|EQUIVALENCE|t-test between groups||||||0.23|||||||t-test, 2 sided|no adjustment for multiple comparison. non parametric||||||0.23
72550219|NCT01882647|144630533|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.01
72550220|NCT01882647|144630534|SUPERIORITY_OR_OTHER||||||<|0.01||||||The pre-specified threshold for statistical significance was ≤0.05.|Cochran-Mantel-Haenszel|||Treatment groups were compared with respect to each of the clinical signs of psoriasis (scaling, erythema and plaque elevation).||||<0.01
72583182|NCT03103087|144696969|SUPERIORITY||||||<|0.0001||||||LS means and p-value for test of difference is relugolix plus E2/NETA minus placebo based on mixed-effect model with treatment, visit, region, Baseline MBL, and treatment by visit interaction included as fixed effects.|Mixed Models Analysis|||||||<0.0001
72583183|NCT03103087|144696970|SUPERIORITY||||||<|0.0001||||||P-value was based on Cochran-Mantel-Haenszel test stratified by Baseline MBL volume (\< 225 mL, ≥ 225 mL) and geographic region (North America, Rest of World).|Cochran-Mantel-Haenszel|||||||<0.0001
72583184|NCT03103087|144696971|SUPERIORITY||||||<|0.0001||||||LS means and p-value for test of difference is relugolix plus E2/NETA minus placebo based on mixed-effect model with treatment, visit, region, Baseline MBL, and treatment by visit interaction included.|Mixed Models Analysis|||||||<0.0001
72412826|NCT02223390|144333808|SUPERIORITY|A sample size of 60 was chosen as adequate to examine the feasibility and acceptability of a pilot randomized controlled trial (RCT) with two conditions.||||||0.08||||||A priori threshold for statistical significance was p\<.05. The p-value presented corresponds to the time by condition interaction parameter.|Mixed Models Analysis|To assess changes in PTSD symptoms over time by intervention condition, linear mixed models were fit using the PROC MIXED procedure in SAS.||Statistical analyses reported below is for PCL - Total at 3 months.||||0.08
72583185|NCT03103087|144696972|SUPERIORITY||||||<|0.0001||||||P-value was based on Cochran-Mantel-Haenszel test stratified by Baseline MBL volume (\< 225 mL, ≥ 225 mL) and geographic region (North America, Rest of World).|Cochran-Mantel-Haenszel|||||||<0.0001
72583186|NCT03103087|144696973|SUPERIORITY||||||<|0.0001||||||LS means and p-value for test of difference is relugolix plus E2/NETA minus placebo based on mixed-effect model with treatment, visit, region, Baseline MBL, and treatment by visit interaction included as fixed effects.|Mixed Models Analysis|||||||<0.0001
72583187|NCT03103087|144696974|SUPERIORITY||||||<|0.0001||||||LS means and p-value for test of difference is relugolix plus E2/NETA minus placebo based on mixed-effect model with treatment, visit, region, Baseline MBL, and treatment by visit interaction included as fixed effects.|Mixed Models Analysis|||||||<0.0001
72583188|NCT03103087|144696976|SUPERIORITY||||||<|0.0001||||||LS means and p-value for test of difference is relugolix plus E2/NETA minus placebo based on mixed-effect model with treatment, visit, region, Baseline MBL, and treatment by visit interaction included as fixed effects.|Mixed Models Analysis|||||||<0.0001
72583189|NCT03103087|144696983|SUPERIORITY|||||||0.0004||||||P-value was based on Cochran-Mantel-Haenszel test stratified by Baseline MBL volume (\< 225 mL, ≥ 225 mL) and geographic region (North America, Rest of World).|Cochran-Mantel-Haenszel|||||||0.0004
72583190|NCT04231825|144697031|SUPERIORITY|||||||0.55|||||||ANCOVA|||||||0.55
72583191|NCT04231825|144697032|SUPERIORITY|||||||0.51|||||||ANCOVA|||||||0.51
72583192|NCT04231825|144697033|SUPERIORITY|||||||0.8|||||||ANCOVA|||||||0.80
72583193|NCT04231825|144697034|SUPERIORITY|||||||0.02|||||||ANCOVA|||||||0.02
72583194|NCT04231825|144697035|SUPERIORITY|||||||0.03|||||||ANCOVA|||||||0.03
72412827|NCT02223390|144333809|SUPERIORITY|A sample size of 60 was chosen as adequate to examine the feasibility and acceptability of a pilot RCT with two conditions.||||||0.05||||||A priori threshold was defined as p\<0.05.|Chi-squared|||||||0.05
72550221|NCT03292653|144630541|SUPERIORITY||Difference in Least Squares (LS) Means|1.26|STANDARD_ERROR_OF_MEAN|3.64||0.736|TWO_SIDED|90.0|-5.4|7.93|||ANCOVA|||Analysis of Covariance (ANCOVA) model with fixed effects for treatment and stratification factors of baseline participant status (diabetic/non-diabetic, ejection fraction status (reduced/preserved) with baseline plasma volume as the covariate.||7.93|-5.4|0.736
72412828|NCT01666002|144333849|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Chi-squared|||||||<0.05
72412829|NCT01666002|144333850|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
72412830|NCT00383435|144333874|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||ANCOVA|||||||<0.001
72412831|NCT00383435|144333874|SUPERIORITY_OR_OTHER_LEGACY|||||||0.007|||||||ANCOVA|||||||0.007
72412832|NCT00383435|144333875|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||ANCOVA|||||||<0.001
72412833|NCT00383435|144333875|SUPERIORITY_OR_OTHER_LEGACY|||||||0.029|||||||ANCOVA|||||||0.029
72412834|NCT00383435|144333876|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002|||||||ANCOVA|||||||0.002
72550222|NCT03292653|144630541|SUPERIORITY||Difference in LS Means|-1.02|STANDARD_ERROR_OF_MEAN|3.38||0.7694|TWO_SIDED|90.0|-7.22|5.18|||ANCOVA|||ANCOVA model with fixed effects for treatment and stratification factors of baseline participant status (diabetic/non-diabetic, ejection fraction status (reduced/preserved) with baseline plasma volume as the covariate.||5.18|-7.22|0.7694
72550223|NCT03292653|144630542|SUPERIORITY||Difference in LS Means|-0.04|STANDARD_ERROR_OF_MEAN|0.03||0.184|TWO_SIDED|90.0|-0.09|0.01|||ANCOVA|||ANCOVA model with fixed effects for treatment and stratification factors of baseline participant status (diabetic/non-diabetic), ejection fraction status (reduced/preserved) with baseline plasma volume as the covariate.||0.01|-0.09|0.184
72550224|NCT03292653|144630542|SUPERIORITY||Difference in LS Means|-0.03|STANDARD_ERROR_OF_MEAN|0.03||0.3397|TWO_SIDED|90.0|-0.07|0.02|||ANCOVA|||ANCOVA model with fixed effects for treatment and stratification factors of baseline participant status (diabetic/non-diabetic), ejection fraction status (reduced/preserved) with baseline plasma volume as the covariate.||0.02|-0.07|0.3397
72550225|NCT03292653|144630543|SUPERIORITY||Difference in LS Means|-17.07|STANDARD_ERROR_OF_MEAN|9.12||0.094|TWO_SIDED|90.0|-33.79|-0.35|||ANCOVA|||ANCOVA model with fixed effects for treatment and stratification factors of baseline participant status (diabetic/non-diabetic), ejection fraction status (reduced/preserved) with baseline plasma volume as the covariate.||-0.35|-33.79|0.094
72550226|NCT03292653|144630543|SUPERIORITY||Difference in LS Means|-12.09|STANDARD_ERROR_OF_MEAN|8.49||0.1878|TWO_SIDED|90.0|-27.65|3.46|||ANCOVA|||ANCOVA model with fixed effects for treatment and stratification factors of baseline participant status (diabetic/non-diabetic), ejection fraction status (reduced/preserved) with baseline plasma volume as the covariate.||3.46|-27.65|0.1878
72550227|NCT03292653|144630544|SUPERIORITY||Difference in LS Means|-4.82|STANDARD_ERROR_OF_MEAN|5.8||0.4269|TWO_SIDED|90.0|-15.45|5.8|||ANCOVA|||ANCOVA model with fixed effects for treatment and stratification factors of baseline participant status (diabetic/non-diabetic), ejection fraction status (reduced/preserved) with baseline plasma volume as the covariate.||5.8|-15.45|0.4269
72550228|NCT03292653|144630544|SUPERIORITY||Difference in LS Means|-6.36|STANDARD_ERROR_OF_MEAN|5.39||0.2684|TWO_SIDED|90.0|-16.24|3.52|||ANCOVA|||ANCOVA model with fixed effects for treatment and stratification factors of baseline participant status (diabetic/non-diabetic), ejection fraction status (reduced/preserved) with baseline plasma volume as the covariate.||3.52|-16.24|0.2684
72550229|NCT03292653|144630545|SUPERIORITY||Difference in LS Means|847.2|STANDARD_ERROR_OF_MEAN|576.98||0.1761|TWO_SIDED|90.0|-210.46|1904.86|||ANCOVA|||ANCOVA model with fixed effects for treatment and stratification factors of baseline participant status (diabetic/non-diabetic), ejection fraction status (reduced/preserved) with baseline plasma volume as the covariate.||1904.86|-210.46|0.1761
72550230|NCT03292653|144630545|SUPERIORITY||Difference in LS Means|489.33|STANDARD_ERROR_OF_MEAN|579.35||0.4202|TWO_SIDED|90.0|-572.68|1551.34|||ANCOVA|||ANCOVA model with fixed effects for treatment and stratification factors of baseline participant status (diabetic/non-diabetic), ejection fraction status (reduced/preserved) with baseline plasma volume as the covariate.||1551.34|-572.68|0.4202
72550231|NCT03292653|144630546|SUPERIORITY||Difference in LS Means|13.75|STANDARD_ERROR_OF_MEAN|8.53||0.1242|TWO_SIDED|90.0|-1.03|28.53|||ANCOVA|||ANCOVA model with fixed effects for treatment and stratification factors of baseline participant status (diabetic/non-diabetic), ejection fraction status (reduced/preserved) with baseline erythropoietin as the covariate.||28.53|-1.03|0.1242
72550232|NCT03292653|144630546|SUPERIORITY||Difference in LS Means|0.1|STANDARD_ERROR_OF_MEAN|7.73||0.9903|TWO_SIDED|90.0|-13.49|13.3|||ANCOVA|||ANCOVA model with fixed effects for treatment and stratification factors of baseline participant status (diabetic/non-diabetic), ejection fraction status (reduced/preserved) with baseline erythropoietin as the covariate.||13.30|-13.49|0.9903
72550233|NCT03292653|144630547|SUPERIORITY||Difference in LS Means|-150.89|STANDARD_ERROR_OF_MEAN|116.09||0.2121|TWO_SIDED|90.0|-353.57|51.78|||ANCOVA|||ANCOVA model with fixed effects for treatment and stratification factors of baseline participant status (diabetic/non-diabetic), ejection fraction status (reduced/preserved) with baseline NT-proBNP as the covariate.||51.78|-353.57|0.2121
72412835|NCT00383435|144333876|SUPERIORITY_OR_OTHER_LEGACY|||||||0.059|||||||ANCOVA|||||||0.059
72412836|NCT03447769|144333913|SUPERIORITY||Hazard Ratio (HR)|0.94||||0.258|TWO_SIDED|95.0|0.78|1.14||1-sided p-value|Stratified log-rank test||The HR for DFS was calculated, along with its 95% confidence interval, from a stratified Cox model using the same stratification factors as those for the log-rank test.|||1.14|0.78|0.258
72412837|NCT03447769|144333918|SUPERIORITY||Hazard Ratio (HR)|1.09||||0.676|TWO_SIDED|95.0|0.76|1.58||1-sided p-value|Stratified log-rank test||The HR for DFS was calculated, along with its 95% confidence interval, from a stratified Cox model using the same stratification factors as those for the log-rank test|PD-L1 \<1%||1.58|0.76|0.676
72550234|NCT03292653|144630547|SUPERIORITY||Difference in LS Means|-5.26|STANDARD_ERROR_OF_MEAN|96.88||0.9574|TWO_SIDED|90.0|-174.4|163.87|||ANCOVA|||ANCOVA model with fixed effects for treatment and stratification factors of baseline participant status (diabetic/non-diabetic), ejection fraction status (reduced/preserved) with baseline NT-proBNP as the covariate.||163.87|-174.4|0.9574
72550235|NCT03311646|144630553|OTHER|A linear mixed-model was used. The model included terms for cigarette nicotine content (VLNC/NNC), time, cohort, a random effect for subject, and a nicotine content x time interaction. Interaction was dropped when nonsignificant. Reported below is the effect of nicotine content as well as the interaction p-value.|Mean Difference (Final Values)|0.07||||0.92|TWO_SIDED|95.0|-1.27|1.4||alpha=0.05.|Mixed Models Analysis||Mean Difference = VLNC-NNC|Comparison of carbon monoxide during VLNC condition to carbon monoxide during the NNC (baseline) condition.|Interaction p-value: p=0.27|1.4|-1.27|0.92
72550236|NCT03311646|144630554|OTHER|A linear mixed-model was used. The model included terms for cigarette nicotine content (VLNC/NNC), time, cohort, a random effect for subject, and a nicotine content x time interaction. Interaction was dropped when nonsignificant. Reported below is the effect of nicotine content as well as the interaction p-value.|Mean Difference (Final Values)|1.13||||0.15|TWO_SIDED|95.0|-0.41|2.66||alpha=0.05|Mixed Models Analysis||Mean Difference = VLNC-NNC|Comparison of cigarette per day during VLNC condition to cigarette per day during the NNC (baseline) condition.|Interaction p=0.23|2.66|-0.41|0.15
72552737|NCT00377260|144636486|SUPERIORITY_OR_OTHER|||||||0.07||95.0|||||Regression, Logistic|The comparison was adjusted for site, history of recurrent acute otitis media and exposure to other children.||Null hypothesis: There is no difference between the two treatment groups regarding the proportion of children with oral thrush.||||.07
72412838|NCT03447769|144333918|SUPERIORITY||Hazard Ratio (HR)|0.6||||0.036|TWO_SIDED|95.0|0.34|1.05||1-sided p-value|Stratified log-rank test||The HR for DFS was calculated, along with its 95% confidence interval, from a stratified Cox model using the same stratification factors as those for the log-rank test|PD-L1 ≥1% and \<49%||1.05|0.34|0.036
72412839|NCT03447769|144333918|SUPERIORITY||Hazard Ratio (HR)|1.33||||0.823|TWO_SIDED|95.0|0.73|2.43||1-sided p-value|Stratified log-rank test||The HR for DFS was calculated, along with its 95% confidence interval, from a stratified Cox model using the same stratification factors as those for the log-rank test|PD-L1 ≥50%||2.43|0.73|0.823
72412840|NCT03447769|144333919|SUPERIORITY||Hazard Ratio (HR)|1.22||||0.872|TWO_SIDED|95.0|0.87|1.72||1-sided p-value|Stratified log-rank test||The HR for DFS was calculated, along with its 95% confidence interval, from a stratified Cox model using the same stratification factors as those for the log-rank test.|CD8 \< median||1.72|0.87|0.872
72412841|NCT03447769|144333919|SUPERIORITY||Hazard Ratio (HR)|0.91||||0.303|TWO_SIDED|95.0|0.62|1.33||1-sided p-value|Stratified log-rank test||The HR for DFS was calculated, along with its 95% confidence interval, from a stratified Cox model using the same stratification factors as those for the log-rank test.|CD8 ≥ median||1.33|0.62|0.303
72550237|NCT03311646|144630555|OTHER|A linear mixed-model was used. The model included terms for cigarette nicotine content (VLNC/NNC), time, cohort, a random effect for subject, and a nicotine content x time interaction. Interaction was dropped when nonsignificant. Reported below is the effect of nicotine content as well as the interaction p-value.|Mean Difference (Final Values)|3.19|||<|0.001|TWO_SIDED|95.0|1.77|4.6|||Mixed Models Analysis||Mean Difference=VLNC-NNC|Comparison of Minnesota Nicotine Withdrawal Scale during VLNC condition to Minnesota Nicotine Withdrawal Scale during the NNC (baseline) condition.|Interaction p=0.95|4.60|1.77|<0.001
72412842|NCT01343407|144333940|OTHER||Difference in Least Squares Means (LSM)|-22.2||||0.011|TWO_SIDED|90.0|-35.7|-8.7|||Linear mixed effects model|||||-8.7|-35.7|0.011
72550238|NCT03311646|144630556|OTHER|A linear mixed-model was used. The model included terms for cigarette nicotine content (VLNC/NNC), time, cohort, a random effect for subject, and a nicotine content x time interaction. Interaction was dropped when nonsignificant. Reported below is the effect of nicotine content as well as the interaction p-value.|Mean Difference (Final Values)|0.2||||0.84|TWO_SIDED|95.0|-2.0|2.5||alpha=0.05|Mixed Models Analysis||Mean Difference = VLNC-NNC|Comparison of carbon monoxide during VLNC condition to carbon monoxide during the NNC (baseline) condition.|Interaction p=0.94|2.5|-2.0|0.84
72550239|NCT03765502|144630558|SUPERIORITY||||||<|0.0001|||||||McNemar|Crossover design: paired test||||||<.0001
72550240|NCT03765502|144630559|SUPERIORITY||||||<|0.0001|||||||McNemar|Crossover design: paired test||||||<.0001
72550241|NCT00683020|144630565|NON_INFERIORITY_OR_EQUIVALENCE|Mean changes in comparison groups are not equal.|Mean Difference (Net)|2.0|STANDARD_ERROR_OF_MEAN|0.9||0.03|TWO_SIDED|95.0|0.1|3.9|||Regression, Linear|Adjusted for baseline values.||||3.9|0.1|0.03
72412843|NCT01343407|144333940|OTHER||Difference in LSM|-18.9||||0.023|TWO_SIDED|90.0|-32.1|-5.8|||Linear mixed effects model|||||-5.8|-32.1|0.023
72412844|NCT01343407|144333941|OTHER||LS Mean Ratio (LSMR)|0.48||||0.006|TWO_SIDED|90.0|0.32|0.72|||Linear mixed effects model||||% Inhibition: 52.2 (90% CI: 28.3, 68.2). The % Inhibition of FEV1\*hr (reduction of the allergen-induced LAR) for MK-1029 vs Placebo was calculated as 100\*(1-LSMR).|0.72|0.32|0.006
72583195|NCT03190993|144697036|OTHER|Linear mixed effect models were used to test if changes (Day 28 - Baseline) were equal between treatment groups (primary outcome).|Mean Difference (Net)|0.56|STANDARD_ERROR_OF_MEAN|0.43|=|0.22|TWO_SIDED||||||Regression, Linear|||||||=0.22
72583196|NCT02549859|144697037|SUPERIORITY||||||<|0.05|||||||Paired t-test, 2 sided|||||||<0.05
72583197|NCT02549859|144697038|SUPERIORITY||||||<|0.01|||||||Paired t-test, 2 sided|||||||<0.01
72583198|NCT02549859|144697039|SUPERIORITY||||||<|0.01|||||||Paired t-test, 2 sided|||||||<0.01
72583199|NCT02549859|144697040|SUPERIORITY||||||>|0.05|||||||Paired t-test, 2 sided|||||||>0.05
72583200|NCT02549859|144697041|SUPERIORITY||||||<|0.05|||||||Paired t-test, 2 sided|||||||<0.05
72583201|NCT02549859|144697042|SUPERIORITY||||||>|0.05|||||||Paired t-test, 2 sided|||||||>0.05
72583202|NCT02549859|144697043|SUPERIORITY||||||>|0.05|||||||Paired t-test, 2 sided|||||||>0.05
72583203|NCT02549859|144697044|SUPERIORITY||||||<|0.01|||||||Paired t-test, 2 sided|||||||<0.01
72583204|NCT02549859|144697045|SUPERIORITY||||||<|0.05|||||||Paired t-test, 2 sided|||||||<0.05
72583205|NCT02549859|144697046|SUPERIORITY||||||>|0.05|||||||Paired t-test, 2 sided|||||||>0.05
72583206|NCT02549859|144697047|SUPERIORITY||||||<|0.01|||||||Paired t-test, 2 sided|||||||<0.01
72583207|NCT02549859|144697048|SUPERIORITY||||||<|0.001|||||||Paired t-test, 2 sided|||||||<0.001
72583208|NCT02549859|144697049|SUPERIORITY||||||<|0.05|||||||Paired t-test, 2 sided|||||||<0.05
72583209|NCT02549859|144697050|SUPERIORITY||||||>|0.05|||||||Paired t-test, 2 sided|||||||>0.05
72583210|NCT02549859|144697051|SUPERIORITY||||||>|0.05|||||||Paired t-test, 2 sided|||||||>0.05
72583211|NCT02549859|144697052|SUPERIORITY||||||<|0.05|||||||Paired t-test, 2 sided|||||||<0.05
72583212|NCT02549859|144697053|SUPERIORITY||||||<|0.05|||||||Paired t-test, 2 sided|||||||<0.05
72583213|NCT02549859|144697054|SUPERIORITY||||||<|0.05|||||||Paired t-test, 2 sided|||||||<0.05
72412845|NCT01343407|144333941|OTHER||LS Mean Ratio (LSMR)|0.58||||0.012|TWO_SIDED|90.0|0.41|0.81|||Linear mixed effects model||||% Inhibition: 42.4 (90% CI: 19.3, 58.8) The % Inhibition of FEV1\*hr (reduction of the allergen-induced LAR) for MK-1029 vs Placebo was calculated as 100\*(1-LSMR).|0.81|0.41|0.012
72583214|NCT02549859|144697055|SUPERIORITY||||||>|0.05|||||||Paired t-test, 2 sided|||||||>0.05
72583215|NCT02549859|144697056|SUPERIORITY||||||>|0.05|||||||Paired t-test, 2 sided|||||||>0.05
72583216|NCT01062425|144697126|SUPERIORITY_OR_OTHER_LEGACY|||||||0.005||||||One-sided test with significance level of 0.15.|Z-test|||The null hypothesis was that the 6m PFS rates for both arms are 50%, and the alternative hypothesis was that patients receiving the experimental regimen would have a 6-month PFS rate of 66%. With 150 eligible patients, there would be an 80% statistical power to detect the 16% absolute increase in 6m PFS at a significance level of 0.15, using a one-sided Z test for two proportions.||||0.005
72583217|NCT01062425|144697127|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.87||||0.44|TWO_SIDED|95.0|0.6|1.24||Significance level 0.05, two-sided test.|Log Rank||Placebo is the reference arm for the hazard ratio.|||1.24|0.6|0.44
72583218|NCT01062425|144697127|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.91||||0.648|TWO_SIDED|95.0|0.62|1.34|||Regression, Cox||Placebo is reference level for the hazard ratio.|Multivariate analysis with the Cox proportional hazard model for overall survival was performed with the stratification variables as fixed variables to assess the treatment effect adjusting patient-specific risk factors. The covariates evaluated for the multivariate models were assigned protocol treatment, MGMT methylation status, and RPA risk class.||1.34|0.62|0.648
72583219|NCT01062425|144697128|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.67||||0.03|TWO_SIDED|95.0|0.47|0.95||Significance level 0.05, two-sided test.|Log Rank||Placebo is the reference arm for the hazard ratio.|||0.95|0.47|0.03
72583220|NCT01062425|144697128|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.67||||0.036|TWO_SIDED|95.0|0.46|0.97|||Regression, Cox||Placebo is the reference arm.|Multivariate analysis with the Cox proportional hazard model for progression-free survival was performed with the stratification variables as fixed variables to assess the treatment effect adjusting patient-specific risk factors. The covariates evaluated for the multivariate models were assigned protocol treatment, MGMT methylation status, and recursive partitioning analysis (RPA) risk class.||0.97|0.46|0.036
72583221|NCT01062425|144697129|SUPERIORITY_OR_OTHER_LEGACY|||||||0.02||||||Significance level 0.05, two-sided test.|Chi-squared|||||||0.02
72583222|NCT02342678|144697130|SUPERIORITY||Mean Difference (Final Values)|0.9||||0.13|TWO_SIDED|95.0|-0.3|2.2|||ANCOVA|||||2.2|-0.3|0.13
72583223|NCT02342678|144697131|SUPERIORITY||Mean Difference (Final Values)|0.4||||0.18|TWO_SIDED|95.0|-0.2|1.1|||ANCOVA|||||1.1|-0.2|0.18
72583224|NCT02342678|144697132|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.89|TWO_SIDED|95.0|-1.2|1.3|||ANCOVA|||||1.3|-1.2|0.89
72583225|NCT02342678|144697133|SUPERIORITY||Mean Difference (Final Values)|0.9||||0.13|TWO_SIDED|95.0|-0.3|2.0|||ANCOVA|||||2.0|-0.3|0.13
72583226|NCT02342678|144697134|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.73|TWO_SIDED|95.0|-0.3|0.4|||ANCOVA|||||0.4|-0.3|0.73
72583227|NCT02342678|144697135|SUPERIORITY||Mean Difference (Final Values)|-19.3||||0.38|TWO_SIDED|95.0|-62.9|24.3|||ANCOVA|||||24.3|-62.9|0.38
72583228|NCT02342678|144697136|SUPERIORITY||Mean Difference (Final Values)|5.6||||0.24|TWO_SIDED|95.0|-3.7|14.8|||ANCOVA|||||14.8|-3.7|0.24
72583229|NCT02342678|144697137|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.46|TWO_SIDED|95.0|-0.4|0.9|||ANCOVA|||||0.9|-0.4|0.46
72583230|NCT01597778|144697150|SUPERIORITY||Difference in Kaplan-Meier estimates|6.1||||0.4092|TWO_SIDED|95.0|-5.2|17.4||Statistical significance was determined using a pre-specified threshold of 0.05. Final p-value is adjusted for the interim looks per study design.|Z-test to compare the Kaplan-Meier Est.|||The primary null hypothesis of the study is that there is no difference between the 2 year PFS probabilities for dUCB vs. haplo-BM.||17.4|-5.2|0.4092
72412846|NCT01343407|144333942|OTHER||LSM Difference|85.84|||<|0.001|TWO_SIDED|90.0|65.3|106.4|||Linear mixed effects model||Full inhibition is ≥74% inhibition of blood eosinophil CD11b expression at trough|||106.4|65.3|<0.001
72412847|NCT01343407|144333942|OTHER||LSM Difference|83.29|||<|0.001|TWO_SIDED|90.0|63.9|102.7|||Linear mixed effects model||Full inhibition is ≥74% inhibition of blood eosinophil CD11b expression at trough|||102.7|63.9|<0.001
72550242|NCT00683020|144630566|NON_INFERIORITY_OR_EQUIVALENCE|Mean changes in comparison groups are not equal.|Mean Difference (Net)|1.4|STANDARD_ERROR_OF_MEAN|1.2||0.23|TWO_SIDED|95.0|-0.9|3.6|||Regression, Linear|Adjusted for baseline values.||||3.6|-0.9|0.23
72550243|NCT00683020|144630567|NON_INFERIORITY_OR_EQUIVALENCE|Days in comparison groups are not equal.|Rate Ratio|0.6||||0.25|TWO_SIDED|95.0|0.3|1.4|||Negative Binomial Models|Adjusted for baseline values.||||1.4|0.3|0.25
72550244|NCT00683020|144630568|NON_INFERIORITY_OR_EQUIVALENCE|Proportions in comparison groups are not equal.|Odds Ratio (OR)|0.5||||0.18|TWO_SIDED|95.0|0.2|1.4|||Regression, Logistic|Adjusted for baseline values.||||1.4|0.2|0.18
72550245|NCT00683020|144630569|NON_INFERIORITY_OR_EQUIVALENCE|Mean changes in comparison groups are not equal.|Mean Difference (Net)|0.3|STANDARD_ERROR_OF_MEAN|0.1||0.008|TWO_SIDED|95.0|0.1|0.5|||Regression, Linear|Adjusted for baseline values.||||0.5|0.1|0.008
72550246|NCT00683020|144630570|NON_INFERIORITY_OR_EQUIVALENCE|Mean changes in comparison groups are not equal.|Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|0.1||0.87|TWO_SIDED|95.0|-0.2|0.2|||Regression, Linear|Adjusted for baseline values.||||0.2|-0.2|0.87
72550247|NCT00683020|144630571|NON_INFERIORITY_OR_EQUIVALENCE|Mean changes in comparison groups are not equal.|Mean Difference (Net)|1.1|STANDARD_ERROR_OF_MEAN|1.6||0.49|TWO_SIDED|95.0|-2.1|4.2|||Regression, Linear|Adjusted for baseline values.||||4.2|-2.1|0.49
72550248|NCT00683020|144630572|NON_INFERIORITY_OR_EQUIVALENCE|Mean changes in comparison groups are not equal.|Mean Difference (Net)|1.3|STANDARD_ERROR_OF_MEAN|2.2||0.54|TWO_SIDED|95.0|-3.0|5.6|||Regression, Linear|Adjusted for baseline values.||||5.6|-3.0|0.54
72550249|NCT00683020|144630573|NON_INFERIORITY_OR_EQUIVALENCE|Mean changes in comparison groups are not equal.|Mean Difference (Net)|2.0|STANDARD_ERROR_OF_MEAN|1.2||0.11|TWO_SIDED|95.0|-0.4|4.4|||Regression, Linear|Adjusted for baseline values.||||4.4|-0.4|0.11
72550250|NCT00683020|144630574|NON_INFERIORITY_OR_EQUIVALENCE|Mean changes in comparison groups are not equal.|Mean Difference (Net)|-0.3|STANDARD_ERROR_OF_MEAN|0.2||0.13|TWO_SIDED|95.0|-0.6|0.1|||Regression, Linear|Adjusted for baseline values.||||0.1|-0.6|0.13
72550251|NCT00683020|144630575|NON_INFERIORITY_OR_EQUIVALENCE|Mean changes in comparison groups are not equal.|Mean Difference (Net)|0.6|STANDARD_ERROR_OF_MEAN|2.3||0.78|TWO_SIDED|95.0|-3.8|5.1|||Regression, Linear|Adjusted for baseline values.||||5.1|-3.8|0.78
72550252|NCT00683020|144630576|NON_INFERIORITY_OR_EQUIVALENCE|Mean changes in comparison groups are not equal.|Mean Difference (Net)|2.1|STANDARD_ERROR_OF_MEAN|1.4||0.13|TWO_SIDED|95.0|-0.6|4.9|||Regression, Linear|Adjusted for baseline values.||||4.9|-0.6|0.13
72550253|NCT03127137|144630577|SUPERIORITY|||||||0.05||||||The reported p-value was calculated.|Fisher Exact|||||||.05
72583231|NCT01597778|144697150|SUPERIORITY||Hazard Ratio (HR)|1.3||||0.06|TWO_SIDED|95.0|0.99|1.7||Statistical significance was determined using a pre-specified threshold of 0.05|Regression, Cox|||The null hypothesis of the study is that there is no difference between the 2 year PFS probabilities for dUCB vs. haplo-BM after adjustment for age, performance score, and disease type.||1.70|0.99|0.060
72583232|NCT01597778|144697152|SUPERIORITY|||||||0.046||||||Statistical significance was determined using a pre-specified threshold of 0.05|Gray's test for cumulative Incidence|Estimate cumulative incidence functions from competing risks data and test equality of 2 trt grps. Death before neutrophil recovery is competing risk.||The null hypothesis is that there is no difference between the neutrophil engraftment post-transplantation for dUCB vs. haplo-BM.||||0.046
72550254|NCT03127137|144630578|SUPERIORITY||Risk Ratio (RR)|1.53|||||TWO_SIDED|95.0|0.82|2.86||||||||2.86|.82|
72550255|NCT01239121|144630595|SUPERIORITY_OR_OTHER||Slope|0.6||||0.175|TWO_SIDED|95.0|-0.27|1.5|||Regression, Linear|||||1.5|-0.27|0.175
72550256|NCT01239121|144630596|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.0||||0.964|TWO_SIDED|95.0|0.49|2.1|||Regression, Logistic|||||2.1|.49|0.964
72550257|NCT03657160|144630601|SUPERIORITY||Hazard Ratio (HR)|0.45|||<|0.001|TWO_SIDED|95.0|0.27|0.73|||Log Rank|||||0.73|0.27|<0.001
72550258|NCT03657160|144630602|SUPERIORITY||Hazard Ratio (HR)|0.56||||0.0043|TWO_SIDED|95.0|0.37|0.86|||Log Rank|||||0.86|0.37|0.0043
72550259|NCT03657160|144630603|SUPERIORITY||Hazard Ratio (HR)|0.59||||0.0204|TWO_SIDED|95.0|0.39|0.91|||Log Rank|||||0.91|0.39|0.0204
72550260|NCT03657160|144630604|SUPERIORITY||Hazard Ratio (HR)|0.48||||0.0668|TWO_SIDED|95.0|0.22|1.04|||Log Rank|||||1.04|0.22|0.0668
72412848|NCT02328326|144334022|SUPERIORITY||Mean Difference (Net)|2.6||||0.048|TWO_SIDED|95.0|0.02|5.18|||Regression, Linear|Model was adjusted for baseline value of PAM, insulin use, randomization stratification variables: care partner not in home and PAM cutoff of 40|Net difference defined as 12 months minus baseline|The null hypothesis was that change (baseline to 12 months) in PAM is the same for CO-IMPACT (intervention) compared to PACT (control). The alternative hypothesis is that that COIMPACT will significantly increase patient participants' PAM score compared to patient participants in PACT.||5.18|0.02|0.048
72550261|NCT03657160|144630605|SUPERIORITY||Hazard Ratio (HR)|0.63||||0.1458|TWO_SIDED|95.0|0.34|1.17|||Log Rank|||||1.17|0.34|0.1458
72550262|NCT03657160|144630606|SUPERIORITY||Hazard Ratio (HR)|0.64||||0.0105|TWO_SIDED|95.0|0.46|0.91|||Log Rank|||||0.91|0.46|0.0105
72412849|NCT02328326|144334023|SUPERIORITY||Mean Difference (Net)|0.9||||0.32|TWO_SIDED|95.0|-0.87|2.67|||Regression, Linear|Model adjusted for baseline value of ukpds, insulin use, site, randomization stratification variables: care partner not in home and PAM cutoff of 40|Net difference defined as 12 months minus baseline. Reference for comparison is PACT.|The null hypothesis was that change (baseline to 12 months) in ukpds 5 year risk score is the same for CO-IMPACT (intervention) compared to PACT (control). The alternative hypothesis is that that COIMPACT will significantly decrease patient participants' 5-year cardiovascular event risk.||2.67|-0.87|0.32
72412850|NCT02328326|144334024|SUPERIORITY||Mean Difference (Net)|0.71||||0.01|TWO_SIDED|95.0|0.2|1.22|||Regression, Linear|Model adjusted for BL value of Healthy Eating, insulin use, randomization stratification variables: care partner not in home and PAM cutoff of 40|Net difference defined as 12 months minus baseline|The null hypothesis was that change (baseline to 12 months) in Healthy Eating is the same for CO-IMPACT (intervention) compared to PACT (control). The alternative hypothesis is that that COIMPACT will significantly change patient participants' Healthy Eating scores compared to patient participants in PACT.||1.22|0.20|0.01
72550263|NCT04638153|144630614|OTHER||least square mean difference|0.2|||||TWO_SIDED|95.0|-0.2|0.6|||||Month 3|Results based on Mixed-Effect Repeated Measures (MMRM) analysis with gender as a covariate, participant (and/or time) as a random effect; treatment, visit, age and gender as fixed effects using an unstructured covariance matrix.||0.6|-0.2|
72550264|NCT04638153|144630614|OTHER||Least square mean difference|0.5|||||TWO_SIDED|95.0|0.1|0.9|||||Month 3|Results based on MMRM analysis with gender as a covariate, participant (and/or time) as a random effect; treatment, visit, age and gender as fixed effects using an unstructured covariance matrix.||0.9|0.1|
72550265|NCT04638153|144630614|OTHER||Least square mean difference|-0.3|||||TWO_SIDED|95.0|-0.7|0.1|||||Month 3|Results based on MMRM analysis with gender as a covariate, participant (and/or time) as a random effect; treatment, visit, age and gender as fixed effects using an unstructured covariance matrix.||0.1|-0.7|
72550266|NCT04638153|144630614|OTHER||Least square mean difference|-0.1|||||TWO_SIDED|95.0|-0.4|0.1|||||Month 6|Results based on MMRM analysis with gender as a covariate, participant (and/or time) as a random effect; treatment, visit, age and gender as fixed effects using an unstructured covariance matrix.||0.1|-0.4|
72583233|NCT01597778|144697153|SUPERIORITY|||||||0.16||||||Statistical significance was determined using a pre-specified threshold of 0.05|Gray's test for cumulative Incidence|Estimate cumulative incidence functions from competing risks data and test equality of 2 trt grps. Death before Platelet recovery is competing risk.||The null hypothesis is that there is no difference between the platelet engraftment to 20k post-transplantation for dUCB vs. haplo-BM.||||0.160
72583234|NCT01597778|144697153|SUPERIORITY|||||||0.146||||||Statistical significance was determined using a pre-specified threshold of 0.05.|Gray's test for cumulative Incidence|Estimate cumulative incidence functions from competing risks data and test equality of 2 trt grps. Death before Platelet recovery is competing risk.||The null hypothesis is that there is no difference between the platelet engraftment to 50k post-transplantation for dUCB vs. haplo-BM.||||0.146
72583235|NCT01597778|144697155|SUPERIORITY|||||||0.693||||||Statistical significance was determined using a pre-specified threshold of 0.05.|Gray's test for cumulative Incidence|Estimate cumulative incidence functions from competing risks data and test equality of 2 trt grps. Death before 2nd graft failure is competing risk.||The null hypothesis is that there is no difference between the secondary graft failure probabilities post-transplantation for dUCB vs. haplo-BM.||||0.693
72583236|NCT01597778|144697156|SUPERIORITY|||||||0.142||||||Statistical significance was determined using a pre-specified threshold of 0.05.|Gray's test for cumulative Incidence|Estimate cumulative incidence functions from competing risks data and test equality of 2 trt grps. Death prior to aGVHD is competing risk.||The null hypothesis is that there is no difference between the aGVHD grade II - IV probabilities post-transplantation for dUCB vs. haplo-BM.||||0.142
72583237|NCT01597778|144697156|SUPERIORITY|||||||0.604||||||Statistical significance was determined using a pre-specified threshold of 0.05.|Gray's test for cumulative Incidence|Estimate cumulative incidence functions from competing risks data and test equality of 2 trt grps. Death prior to aGVHD is competing risk.||The null hypothesis is that there is no difference between the aGVHD grade III - IV probabilities post-transplantation for dUCB vs. haplo-BM.||||0.604
72583238|NCT01597778|144697157|SUPERIORITY|||||||0.361||||||Statistical significance was determined using a pre-specified threshold of 0.05.|Gray's test for cumulative Incidence|Estimate cumulative incidence functions from competing risks data and test equality of 2 trt grps. Death before cGVHD is competing risk.||The null hypothesis is that there is no difference between the cGVHD probabilities post-transplantation for dUCB vs. haplo-BM.||||0.361
72583239|NCT01597778|144697158|SUPERIORITY|||||||0.0373||||||Statistical significance was determined using a pre-specified threshold of 0.05.|Log Rank|||The null hypothesis is that there is no difference between the OS probabilities at year 2 post-randomization for dUCB vs. haplo-BM.||||0.0373
72583240|NCT01597778|144697158|SUPERIORITY|||||||0.0235||||||Statistical significance was determined using a pre-specified threshold of 0.05.|Log Rank|||The null hypothesis is that there is no difference between the OS probabilities at year 2 post-transplant for dUCB vs. haplo-BM.||||0.0235
72583241|NCT01597778|144697159|SUPERIORITY|||||||0.039||||||Statistical significance was determined using a pre-specified threshold of 0.05.|Gray's test for cumulative Incidence|Estimate cumulative incidence functions from competing risks data and test equality across the two treatment groups.||The null hypothesis is that there is no difference between the TRM probabilities post-randomization for dUCB vs. haplo-BM.||||0.039
72550267|NCT04638153|144630614|OTHER||Least square mean difference|-0.1|||||TWO_SIDED|95.0|-0.4|0.2|||||Month 6|Results based on MMRM analysis with gender as a covariate, participant (and/or time) as a random effect; treatment, visit, age and gender as fixed effects using an unstructured covariance matrix.||0.2|-0.4|
72550268|NCT04638153|144630614|OTHER||Least square mean difference|-0.1|||||TWO_SIDED|95.0|-0.4|0.2|||||Month 6|Results based on MMRM analysis with gender as a covariate, participant (and/or time) as a random effect; treatment, visit, age and gender as fixed effects using an unstructured covariance matrix.||0.2|-0.4|
72583242|NCT01597778|144697159|SUPERIORITY|||||||0.03||||||Statistical significance was determined using a pre-specified threshold of 0.05.|Gray's test for cumulative Incidence|Estimate cumulative incidence functions from competing risks data and test equality across the two treatment groups.||The null hypothesis is that there is no difference between the TRM probabilities post-transplantation for dUCB vs. haplo-BM||||0.030
72583243|NCT01597778|144697160|SUPERIORITY|||||||0.968||||||Statistical significance was determined using a pre-specified threshold of 0.05.|Gray's test for cumulative Incidence|Estimate cumulative incidence functions from competing risks data and test equality of 2 trt grps. Death prior to relapse is competing risk.||The null hypothesis is that there is no difference between the relapse/progression probabilities post-randomization for dUCB vs. haplo-BM.||||0.968
72583244|NCT01597778|144697160|SUPERIORITY|||||||0.907||||||Statistical significance was determined using a pre-specified threshold of 0.05.|Gray's test for cumulative Incidence|Estimate cumulative incidence functions from competing risks data and test equality of 2 trt grps. Death prior to relapse is competing risk.||The null hypothesis is that there is no difference between the relapse/progression probabilities post- transplantation for dUCB vs. haplo-BM.||||0.907
72583245|NCT01597778|144697163|SUPERIORITY|||||||0.0003||||||Statistical significance was determined using a pre-specified threshold of 0.05.|Wilcoxon (Mann-Whitney)|||The null hypothesis is that there is no difference between the total duration of hospitalization within 6 months post-randomization for dUCB vs. haplo-BM.||||0.0003
72583246|NCT04616612|144697208|SUPERIORITY|||||||0.04|||||||Mixed Models Analysis|||||||.04
72583247|NCT04616612|144697209|SUPERIORITY|||||||0.04|||||||ANCOVA|||||||.04
72583248|NCT04616612|144697210|OTHER||||||||||||||||||"Qualitative data evaluated from interviews tailored after the acceptability scale questionnaire. These interview questions specifically asked participant to rate from strongly disagree to strongly agree on each question and then rationalize answers.~Mobile support: 77% of participants agreed that mobile messages supported their health behaviors.~Time required: 85% disagreed that the intervention took too much time to learn.~Program effectiveness: 92% enjoyed this learning approach, with 100% agreeing they could use the information to improve health behaviors.~Rationalization feedback found participants in rural areas reported difficulties accessing texts."|||
72550269|NCT04638153|144630614|OTHER||Least square mean difference|0.0|||||TWO_SIDED|95.0|-0.2|0.2|||||Month 9|Results based on MMRM analysis with gender as a covariate, participant (and/or time) as a random effect; treatment, visit, age and gender as fixed effects using an unstructured covariance matrix.||0.2|-0.2|
72550270|NCT04638153|144630614|OTHER||Least square mean difference|0.0|||||TWO_SIDED|95.0|-0.2|0.2|||||Month 9|Results based on MMRM analysis with gender as a covariate, participant (and/or time) as a random effect; treatment, visit, age and gender as fixed effects using an unstructured covariance matrix.||0.2|-0.2|
72550271|NCT04638153|144630614|OTHER||Least square mean difference|0.0|||||TWO_SIDED|95.0|-0.2|0.2|||||Month 9|Results based on MMRM analysis with gender as a covariate, participant (and/or time) as a random effect; treatment, visit, age and gender as fixed effects using an unstructured covariance matrix.||0.2|-0.2|
72550272|NCT04638153|144630614|OTHER||Least square mean difference|0.0|||||TWO_SIDED|95.0|-0.2|0.2|||||Month 12|Results based on MMRM analysis with gender as a covariate, participant (and/or time) as a random effect; treatment, visit, age and gender as fixed effects using an unstructured covariance matrix.||0.2|-0.2|
72583249|NCT04616612|144697211|SUPERIORITY|||||||0.11|||||||Mixed Models Analysis|||||||0.11
72583250|NCT04616612|144697212|SUPERIORITY|||||||0.11|||||||Mixed Models Analysis|||||||0.11
72583251|NCT04616612|144697213|SUPERIORITY|||||||0.66|||||||Mixed Models Analysis|||||||0.66
72583252|NCT04616612|144697214|SUPERIORITY|||||||0.66|||||||Mixed Models Analysis|||||||0.66
72583253|NCT04616612|144697215|SUPERIORITY|||||||0.84|||||||Mixed Models Analysis|||||||.84
72583254|NCT04616612|144697216|SUPERIORITY|||||||0.84|||||||Mixed Models Analysis|||||||0.84
72583255|NCT04740918|144697217|SUPERIORITY|Cox proportional hazards model, stratified by local hormonal status (estrogen receptors (ER) and/or progesterone receptor (PgR) positive vs. ER and PgR negative/unknown) and Disease status (visceral metastasis without brain metastasis vs. non-visceral metastasis only without brain metastasis \[including locally advanced disease\] vs. Brain metastasis) were used to estimate the Hazard Ratio (HR).|Hazard Ratio (HR)|0.75||||0.2876|TWO_SIDED|95.0|0.44|1.28|||Log Rank|||||1.28|0.44|0.2876
72583256|NCT04740918|144697218|SUPERIORITY|Cox proportional hazards model, stratified by local hormonal status (ER and/or PgR positive vs. ER and PgR negative/unknown) and Disease status (visceral metastasis without brain metastasis vs. non-visceral metastasis only without brain metastasis \[including locally advanced disease\] vs. Brain metastasis) were used to estimate the HR.|Hazard Ratio (HR)|1.59||||0.5151|TWO_SIDED|95.0|0.39|6.43|||Log Rank|||||6.43|0.39|0.5151
72583257|NCT04740918|144697219|SUPERIORITY|A Cochran-Mantel-Haenszel chi-square test, stratified by local hormonal status (ER and/or PgR positive vs. ER and PgR negative/unknown) and Disease status (visceral metastasis without brain metastasis vs. non-visceral metastasis only without brain metastasis \[including locally advanced disease\] vs. Brain metastasis), was used to test for difference in response rates.|Odds Ratio (OR)|1.16||||0.724|TWO_SIDED|95.0|0.5|2.7|||Cochran-Mantel-Haenszel|||||2.70|0.50|0.7240
72583258|NCT04740918|144697220|SUPERIORITY|Cox proportional hazards model, stratified by local hormonal status (ER and/or PgR positive vs. ER and PgR negative/unknown) and Disease status (visceral metastasis without brain metastasis vs. non-visceral metastasis only without brain metastasis \[including locally advanced disease\] vs. Brain metastasis) were used to estimate the HR.|Hazard Ratio (HR)|0.65||||0.3531|TWO_SIDED|95.0|0.26|1.61|||Log Rank|||||1.61|0.26|0.3531
72583259|NCT04740918|144697221|SUPERIORITY|Cox proportional hazards model, stratified by local hormonal status (ER and/or PgR positive vs. ER and PgR negative/unknown) and Disease status (visceral metastasis without brain metastasis vs. non-visceral metastasis only without brain metastasis \[including locally advanced disease\] vs. Brain metastasis) were used to estimate the HR.|Hazard Ratio (HR)|1.35||||0.7175|TWO_SIDED|95.0|0.27|6.81|||Log Rank|||||6.81|0.27|0.7175
72583260|NCT04740918|144697222|SUPERIORITY|Cox proportional hazards model, stratified by local hormonal status (ER and/or PgR positive vs. ER and PgR negative/unknown) and Disease status (visceral metastasis without brain metastasis vs. non-visceral metastasis only without brain metastasis \[including locally advanced disease\] vs. Brain metastasis) were used to estimate the HR.||||||0.3173|||||||Log Rank|||||||0.3173
72583261|NCT04740918|144697223|SUPERIORITY|Cox proportional hazards model, stratified by local hormonal status (ER and/or PgR positive vs. ER and PgR negative/unknown) and Disease status (visceral metastasis without brain metastasis vs. non-visceral metastasis only without brain metastasis \[including locally advanced disease\] vs. Brain metastasis) were used to estimate the HR.|Hazard Ratio (HR)|1.19||||0.8658|TWO_SIDED|95.0|0.16|8.6|||Log Rank|||||8.60|0.16|0.8658
72583262|NCT04740918|144697224|SUPERIORITY|Cox proportional hazards model, stratified by local hormonal status (ER and/or PgR positive vs. ER and PgR negative/unknown) and Disease status (visceral metastasis without brain metastasis vs. non-visceral metastasis only without brain metastasis \[including locally advanced disease\] vs. Brain metastasis) were used to estimate the HR.|Hazard Ratio (HR)|1.16||||0.8407|TWO_SIDED|95.0|0.27|4.99|||Log Rank|||||4.99|0.27|0.8407
72583263|NCT02524847|144697234|OTHER||Overall response rate (%)|55.2|||<|0.001|TWO_SIDED|95.0|35.7|73.6|||t-test, 2 sided|2-sided p-value for testing the null hypothesis H0: Standard therapy has a CR+PR rate = 10% after 4 weeks, using the exact Binomial test.||||73.6|35.7|<.001
72583264|NCT01268527|144697256|SUPERIORITY||Difference in LSM (vehicle - E6201 gel)|711.4||||0.0038|TWO_SIDED|95.0|292.5|1130.3|||ANCOVA|||The following hypotheses were based on the Full Analysis Population: null Hypothesis and alternative hypothesis. P values, Least Squares Means (LSM), and Confidence Intervals (CI) were obtained from ANCOVA model with factors for treatment and baseline psoriatic infiltrate thickness as a continuous covariate.||1130.3|292.5|0.0038
72550273|NCT04638153|144630614|OTHER||Least square mean difference|0.1|||||TWO_SIDED|95.0|-0.2|0.3|||||Month 12|Results based on MMRM analysis with gender as a covariate, participant (and/or time) as a random effect; treatment, visit, age and gender as fixed effects using an unstructured covariance matrix.||0.3|-0.2|
72550274|NCT04638153|144630614|OTHER||Least square mean difference|-0.1|||||TWO_SIDED|95.0|-0.4|0.1|||||Month 12|Results based on MMRM analysis with gender as a covariate, participant (and/or time) as a random effect; treatment, visit, age and gender as fixed effects using an unstructured covariance matrix.||0.1|-0.4|
72550275|NCT04638153|144630624|OTHER||Least square mean difference|0.3|||||TWO_SIDED|95.0|-0.5|1.2|||||Month 3|Results based on MMRM analysis with gender as a covariate, participant (and/or time) as a random effect; treatment, visit, treatment-by-visit interaction, age and gender as fixed effects using an unstructured covariance matrix.||1.2|-0.5|
72550276|NCT04638153|144630624|OTHER||Least square mean difference|1.0|||||TWO_SIDED|95.0|0.2|1.8|||||Month 3|Results based on MMRM analysis with gender as a covariate, participant (and/or time) as a random effect; treatment, visit, treatment-by-visit interaction, age and gender as fixed effects using an unstructured covariance matrix.||1.8|0.2|
72550277|NCT04638153|144630624|OTHER||Least square mean difference|-0.7|||||TWO_SIDED|95.0|-1.5|0.1|||||Month 3|Results based on MMRM analysis with gender as a covariate, participant (and/or time) as a random effect; treatment, visit, treatment-by-visit interaction, age and gender as fixed effects using an unstructured covariance matrix.||0.1|-1.5|
72550278|NCT04638153|144630624|OTHER||Least square mean difference|-0.5|||||TWO_SIDED|95.0|-1.6|0.6|||||Month 6|Results based on MMRM analysis with gender as a covariate, participant (and/or time) as a random effect; treatment, visit, treatment-by-visit interaction, age and gender as fixed effects using an unstructured covariance matrix.||0.6|-1.6|
72550279|NCT04638153|144630624|OTHER||Least square mean difference|0.7|||||TWO_SIDED|95.0|-0.4|1.9|||||Month 6|Results based on MMRM analysis with gender as a covariate, participant (and/or time) as a random effect; treatment, visit, treatment-by-visit interaction, age and gender as fixed effects using an unstructured covariance matrix.||1.9|-0.4|
72550280|NCT04638153|144630624|OTHER||Least square mean difference|-1.2|||||TWO_SIDED|95.0|-2.3|-0.1|||||Month 6|Results based on MMRM analysis with gender as a covariate, participant (and/or time) as a random effect; treatment, visit, treatment-by-visit interaction, age and gender as fixed effects using an unstructured covariance matrix.||-0.1|-2.3|
72550281|NCT04638153|144630624|OTHER||Least square mean difference|0.0|||||TWO_SIDED|95.0|-0.8|0.7|||||Month 9|Results based on MMRM analysis with gender as a covariate, participant (and/or time) as a random effect; treatment, visit, treatment-by-visit interaction, age and gender as fixed effects using an unstructured covariance matrix.||0.7|-0.8|
72550282|NCT04638153|144630624|OTHER||Least square mean difference|0.6|||||TWO_SIDED|95.0|-0.2|1.5|||||Month 9|Results based on MMRM analysis with gender as a covariate, participant (and/or time) as a random effect; treatment, visit, treatment-by-visit interaction, age and gender as fixed effects using an unstructured covariance matrix.||1.5|-0.2|
72550283|NCT04638153|144630624|OTHER||Least square mean difference|-0.7|||||TWO_SIDED|95.0|-1.5|0.2|||||Month 9|Results based on MMRM analysis with gender as a covariate, participant (and/or time) as a random effect; treatment, visit, treatment-by-visit interaction, age and gender as fixed effects using an unstructured covariance matrix.||0.2|-1.5|
72550284|NCT04638153|144630624|OTHER||Least square mean difference|0.1|||||TWO_SIDED|95.0|-1.3|1.5|||||Month 12|Results based on MMRM analysis with gender as a covariate, participant (and/or time) as a random effect; treatment, visit, treatment-by-visit interaction, age and gender as fixed effects using an unstructured covariance matrix.||1.5|-1.3|
72550285|NCT04638153|144630624|OTHER||Least square mean difference|0.7|||||TWO_SIDED|95.0|-1.4|2.8|||||Month 12|Results based on MMRM analysis with gender as a covariate, participant (and/or time) as a random effect; treatment, visit, treatment-by-visit interaction, age and gender as fixed effects using an unstructured covariance matrix.||2.8|-1.4|
72550286|NCT04638153|144630624|OTHER||Least square mean difference|-0.6|||||TWO_SIDED|95.0|-2.6|1.4|||||Month 12|Results based on MMRM analysis with gender as a covariate, participant (and/or time) as a random effect; treatment, visit, treatment-by-visit interaction, age and gender as fixed effects using an unstructured covariance matrix.||1.4|-2.6|
72550287|NCT04006171|144630641|OTHER|||||||0.004|||||||Wilcoxon (Mann-Whitney)|||||||0.004
72550288|NCT04006171|144630642|OTHER|||||||0.004|||||||Roc curve|||||||0.004
72550289|NCT04006171|144630643|OTHER|||||||0.171||||||p value for FSH|Wilcoxon (Mann-Whitney)|for FSH||||||0.171
72550290|NCT04006171|144630643|OTHER|||||||0.176||||||p value for LH|Wilcoxon (Mann-Whitney)|for LH||||||0.176
72550291|NCT04006171|144630644|OTHER|||||||0.306|||||||Wilcoxon (Mann-Whitney)|||||||0.306
72550292|NCT04006171|144630645|OTHER|||||||0.795|||||||Wilcoxon (Mann-Whitney)|||||||0.795
72550293|NCT04006171|144630646|OTHER|||||||0.852|||||||t-test, 2 sided|||||||0.852
72550294|NCT04006171|144630647|OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
72550295|NCT04006171|144630648|OTHER|||||||0.277|||||||Wilcoxon (Mann-Whitney)|||||||0.277
72550296|NCT04006171|144630649|OTHER|||||||0.006|||||||t-test, 2 sided|||||||0.006
72550297|NCT04006171|144630650|OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
72550298|NCT04006171|144630651|OTHER|||||||0.014|||||||Wilcoxon (Mann-Whitney)|||||||0.014
72550299|NCT04006171|144630652|OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
72550300|NCT04006171|144630653|OTHER|||||||0.947||||||for serum glucose|Wilcoxon (Mann-Whitney)|for serum glucose||||||0.947
72550301|NCT04006171|144630653|OTHER|||||||0.906||||||for total cholesterol|Wilcoxon (Mann-Whitney)|for total cholesterol||||||0.906
72550302|NCT04006171|144630653|OTHER|||||||0.428||||||for triglycerides|Wilcoxon (Mann-Whitney)|for triglycerides||||||0.428
72550303|NCT04006171|144630654|OTHER|||||||0.114||||||for high density lipoprotein|t-test, 2 sided|||||||0.114
72550304|NCT04006171|144630654|OTHER|||||||0.504||||||for low density lipoprotein|Wilcoxon (Mann-Whitney)|for low density lipoprotein||||||0.504
72550305|NCT04006171|144630655|OTHER|||||||0.713|||||||Wilcoxon (Mann-Whitney)|||||||0.713
72550306|NCT04006171|144630656|OTHER|||||||0.886|||||||Wilcoxon (Mann-Whitney)|||||||0.886
72552738|NCT00377260|144636486|SUPERIORITY_OR_OTHER||||||>|0.99||95.0|||||Regression, Logistic|The comparison was adjusted for site, history of recurrent acute otitis media and exposure to other children.||Null hypothesis: There is no difference between the two treatment groups regarding the proportion of children with vomiting.||||>.99
72550307|NCT00440557|144630659|NON_INFERIORITY_OR_EQUIVALENCE|Assuming a difference in the mean change in Hb from baseline to the average of the last 8 weeks of treatment through Week 22 of -0.3 g/dL between standard-tx group (TIW) and test-tx group (QW), a pooled standard deviation of 1.7 g/dL, and a noninferiority margin of 1 g/dL, a sample size of approximately 250 participants (125 per group) will provide 90% power to demonstrate that the test treatment group is not inferior to the standard-treatment group for an overall 2-sided 0.05 significance level|Difference of Least Squares Means|-0.17|STANDARD_ERROR_OF_MEAN|0.106||||95.0|-0.38|0.037||This comparison between QW and TIW was performed prior to comparing Q2W with TIW in the statistical analysis 2 according to a planned stepdown procedure for controlling multiplicity.||||The null hypothesis is the mean change in Hb concentration from baseline to the average of the last 8 weeks of treatment (tX) through Week 22 in the QW group is not lower than that of the TIW group by more than 1 g/dL.||0.037|-0.380|
72552739|NCT00377260|144636486|SUPERIORITY_OR_OTHER||||||>|0.99||95.0|||||Regression, Logistic|The comparison was adjusted for site, history of recurrent acute otitis media and exposure to other children.||Null hypothesis: There is no difference between the two treatment groups regarding the proportion of children with rash.||||>.99
72552740|NCT00377260|144636486|SUPERIORITY_OR_OTHER|||||||0.99||95.0|||||Regression, Logistic|The comparison was adjusted for site, history of recurrent acute otitis media and exposure to other children.||Null hypothesis: There is no difference between the two treatment groups regarding the proportion of children with mastoiditis.||||.99
72552741|NCT00377260|144636486|SUPERIORITY_OR_OTHER|||||||0.08||95.0|||||Regression, Logistic|The comparison was adjusted for site, history of recurrent acute otitis media and exposure to other children.||Null hypothesis: There is no difference between the two treatment groups regarding the proportion of children with perforation of their tympanic membrane.||||.08
72552742|NCT00377260|144636487|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||Regression, Logistic|The comparison adjusted for site, history of recurrent acute otitis media and exposure to other children.||Null hypothesis: There is no difference between the two groups regarding the proportion of culture results with at least one AOM pathogen present.||||.002
72552743|NCT00377260|144636487|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Regression, Logistic|The comparison adjusted for site, history of recurrent acute otitis media and exposure to other children.||Null hypothesis: There is no difference between the two groups regarding the proportion of culture results with Streptococcus pneumoniae present.||||<.001
72552744|NCT00377260|144636487|SUPERIORITY_OR_OTHER|||||||0.85||95.0|||||Regression, Logistic|The comparison adjusted for site, history of recurrent acute otitis media and exposure to other children.||Null hypothesis: There is no difference between the two groups regarding the proportion of culture results with Haemophilus influenzae present.||||.85
72552745|NCT00377260|144636487|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Regression, Logistic|The comparison adjusted for site, history of recurrent acute otitis media and exposure to other children.||Null hypothesis: There is no difference between the two groups regarding the proportion of culture results with Moraxella catarrhalis present.||||<.001
72552746|NCT00377260|144636487|SUPERIORITY_OR_OTHER|||||||0.28||95.0|||||Regression, Logistic|The comparison adjusted for site, history of recurrent acute otitis media and exposure to other children.||Null hypothesis: There is no difference between the two groups regarding the proportion of culture results with Streptococcus pyogenes present.||||.28
72552747|NCT00377260|144636488|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Regression, Logistic|The comparison was adjusted for site, history of recurrent acute otitis media and exposure to other children.||Null hypothesis: There is no difference between the two groups regarding the proportion of children colonized with penicillin-susceptible Streptococcus pneumoniae.||||< .001
72552748|NCT00377260|144636489|SUPERIORITY_OR_OTHER|||||||0.1||95.0|||||Regression, Logistic|The comparison adjusted for site, history of recurrent acute otitis media and exposure to other children.||Null hypothesis: There is no difference between the two groups regarding the proportion of culture results with at least one AOM pathogen present.||||.10
72552749|NCT00377260|144636489|SUPERIORITY_OR_OTHER|||||||0.03||95.0|||||Regression, Logistic|The comparison adjusted for site, history of recurrent acute otitis media and exposure to other children.||Null hypothesis: There is no difference between the two groups regarding the proportion of culture results with Streptococcus pneumoniae present.||||.03
72552750|NCT00377260|144636489|SUPERIORITY_OR_OTHER|||||||0.96||95.0|||||Regression, Logistic|The comparison adjusted for site, history of recurrent acute otitis media and exposure to other children.||Null hypothesis: There is no difference between the two groups regarding the proportion of culture results with Haemophilus influenzae present.||||.96
72552751|NCT00377260|144636489|SUPERIORITY_OR_OTHER|||||||0.79||95.0|||||Regression, Logistic|The comparison adjusted for site, history of recurrent acute otitis media and exposure to other children.||Null hypothesis: There is no difference between the two groups regarding the proportion of culture results with Moraxella catarrhalis present.||||.79
72552752|NCT00377260|144636489|SUPERIORITY_OR_OTHER|||||||0.98||95.0|||||Regression, Logistic|The comparison adjusted for site, history of recurrent acute otitis media and exposure to other children.||Null hypothesis: There is no difference between the two groups regarding the proportion of culture results with Streptococcus pyogenes present.||||.98
72550308|NCT00440557|144630659|NON_INFERIORITY_OR_EQUIVALENCE|Assuming a difference in the mean change in Hb from baseline to the average of the last 8 weeks of treatment through Week 22 of -0.3 g/dL between standard-tx group (TIW) and test-tx group (QW), a pooled standard deviation of 1.7 g/dL, and a noninferiority margin of 1 g/dL, a sample size of approximately 250 participants (125 per group) will provide 90% power to demonstrate that the test treatment group is not inferior to the standard-treatment group for an overall 2-sided 0.05 significance level|Difference of Least Squares Means|-0.43|STANDARD_ERROR_OF_MEAN|0.107||||95.0|-0.641|-0.221||Since the non-inferiority was declared in the statistical analysis 1, this comparison between Q2W and TIW was then performed according to a planned stepdown procedure for controlling multiplicity.||||The null hypothesis is the mean change in Hb concentration from baseline to the average of the last 8 weeks of treatment through Week 22 in the Q2W group is not lower than that of the TIW group by more than 1 g/dL.||-0.221|-0.641|
72550309|NCT00440557|144630660|SUPERIORITY_OR_OTHER||Difference in Percentage of Participants|-7.8||||||95.0|-17.2|1.7||||||||1.7|-17.2|
72550310|NCT00440557|144630660|SUPERIORITY_OR_OTHER||Difference in Percentage of Participants|-15.0||||||95.0|-25.0|-5.0||||||||-5.0|-25.0|
72550311|NCT00440557|144630661|SUPERIORITY_OR_OTHER||Difference of Least Squares Means|-0.26||||||95.0|-0.564|0.043|||ANOVA|||||0.043|-0.564|
72550312|NCT00440557|144630661|SUPERIORITY_OR_OTHER||Difference of Least Squares Means|-0.45||||||95.0|-0.755|-0.147|||ANOVA|||||-0.147|-0.755|
72550313|NCT00440557|144630662|SUPERIORITY_OR_OTHER||Difference in Percentage of Participants|-3.9||||||95.0|-9.5|1.6||||||||1.6|-9.5|
72550314|NCT00440557|144630662|SUPERIORITY_OR_OTHER||Difference in Percentage of Participants|-5.5||||||95.0|-11.4|0.3||||||||0.3|-11.4|
72550315|NCT00440557|144630663|SUPERIORITY_OR_OTHER||Difference in Percentage of Participants|-2.7||||||95.0|-14.2|8.7||||||||8.7|-14.2|
72550316|NCT00440557|144630663|SUPERIORITY_OR_OTHER||Difference in Percentage of Participants|-9.9||||||95.0|-21.7|1.8||||||||1.8|-21.7|
72550317|NCT00440557|144630664|SUPERIORITY_OR_OTHER||Difference in Percentage of Participants|2.6||||||95.0|-9.6|14.8||||||||14.8|-9.6|
72550318|NCT00440557|144630664|SUPERIORITY_OR_OTHER||Difference in Percentage of Participants|-3.0||||||95.0|-15.0|9.0||||||||9.0|-15.0|
72550319|NCT00440557|144630665|SUPERIORITY_OR_OTHER||Difference of Least Squares Means|0.03||||||95.0|-0.21|0.27|||ANOVA|||||0.270|-0.210|
72550320|NCT00440557|144630665|SUPERIORITY_OR_OTHER||Difference of Least Squares Means|-0.07||||||95.0|-0.315|0.166|||ANOVA|||||0.166|-0.315|
72550321|NCT00440557|144630666|SUPERIORITY_OR_OTHER||Difference in Percentage of Participants|-8.8||||||95.0|-16.0|-1.9||||||||-1.9|-16|
72550322|NCT00440557|144630666|SUPERIORITY_OR_OTHER||Difference in Percentage of Participants|-10.0||||||95.0|-18.0|-3.2||||||||-3.2|-18.0|
72550323|NCT01973348|144630667|NON_INFERIORITY_OR_EQUIVALENCE|A sample size of 12 subjects per group has been shown to be effective for estimating within-group means and variances when little prior data is available.(Julius, 2005) Based on collected data from 34 subjects and effective size difference of 0.1, we reestimate this study as a noninferiority trial with continuous outcome and power calculated as approximately 80%.||||||0.88|||||||t-test, 1 sided|||||||0.88
72550324|NCT02458469|144630694|SUPERIORITY|||||||0.019|||||||ANOVA|||||||0.019
72550325|NCT02458469|144630694|SUPERIORITY|||||||0.015|||||||Student-Newman-Keuls Method|||||||0.015
72550326|NCT02458469|144630694|SUPERIORITY|||||||0.231|||||||Student-Newman-Keuls Method|||||||0.231
72550327|NCT02458469|144630695|SUPERIORITY|||||||0.749|||||||ANOVA|||||||0.749
72550328|NCT03561883|144630723|SUPERIORITY||Least squares (LS) mean difference|-0.062||||0.5566|TWO_SIDED|95.0|-0.27|0.146|||MMRM||Treatment difference (IW-3718 - placebo)|Treatment difference calculated as least squares mean (LSM) change from baseline at Week 8; IW-3718 - placebo based on an mixed models repeated measures (MMRM) model with week (categorical), treatment group, week-by-treatment group and week-by-baseline value interactions, baseline esophagitis status (present vs. not present), and baseline WHSS (\< 3 vs. ≥ 3) as fixed effect terms and baseline value as a covariate, with subject as a random effect. An unstructured covariance structure was used.||0.146|-0.270|0.5566
72550329|NCT03561883|144630724|SUPERIORITY||LS mean difference|-0.008||||0.9226|TWO_SIDED|95.0|-0.176|0.159|||MMRM|||Treatment difference calculated as LSM change from baseline at Week 8; IW-3718 - placebo based on an MMRM model with week (categorical), treatment group, week-by-treatment group and week-by-baseline value interactions, baseline esophagitis status (present vs. not present), and baseline WHSS (\< 3 vs. ≥ 3) as fixed effect terms and baseline value as a covariate, with subject as a random effect. An unstructured covariance structure was used.||0.159|-0.176|0.9226
72550330|NCT03561883|144630725|SUPERIORITY||Difference in Responder Rate|1.3|||||TWO_SIDED|95.0|-6.9|9.5|||||95% confidence interval (CI) for Difference in Responder Rates is obtained using the Newcombe CI.|||9.5|-6.9|
72550331|NCT03561883|144630725|SUPERIORITY||Odds Ratio (OR)|1.06||||0.7424|TWO_SIDED|95.0|0.76|1.48|||Cochran-Mantel-Haenszel||Odds Ratio for Response (IW-3718 : placebo)|Treatment difference was calculated as the difference in the responder rates at Week 8; IW-3718 - placebo. The 95% CI for the difference in the responder rates was obtained using the Newcombe CI. P value was based on the odds ratio for the response rate (IW-3718:placebo) obtained from the Cochran-Mantel-Haenszel (CMH) tests controlling for baseline esophagitis status and baseline heartburn severity level (\< 3 vs. ≥ 3).||1.48|0.76|0.7424
72550332|NCT03561883|144630726|SUPERIORITY||Difference in Proportion Ratio|1.171||||0.4164|TWO_SIDED|95.0|0.8|1.714||Negative binomial model was used to deal with data overdispersion.|Negative binomial model||Difference in Proportion Ratio, (1500 mg IW-3718 BID + PPI) - (Placebo + PPI)|Poisson regression including the fixed categorical effect of treatment, the baseline esophagitis status (present vs. not present) and baseline WHSS (\<3 vs. ≥3), the covariate of baseline proportion of heartburn-free days, and with the diary entry duration (in days) as a weight variable adjusted in the model was applied.||1.714|0.800|0.4164
72550333|NCT03561883|144630726|OTHER|Negative binomial model was used to deal with data overdispersion|Difference in Proportion Ratio|0.034|||||TWO_SIDED|95.0|-0.054|0.123|||||Difference in Proportion Ratio, (1500 mg IW-3718 BID + PPI) - (Placebo + PPI)|Poisson regression including the fixed categorical effect of treatment, the baseline esophagitis status (present vs. not present) and baseline WHSS (\<3 vs. ≥3), the covariate of baseline proportion of heartburn-free days, and with the diary entry duration (in days) as a weight variable adjusted in the model was applied.||0.123|-0.054|
72550334|NCT06354270|144630727|SUPERIORITY||Adjusted Mean Difference|-1.07|STANDARD_ERROR_OF_MEAN|0.111|<|0.0001|TWO_SIDED|95.0|-1.29|-0.85|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as Test toothpaste minus Reference toothpaste.|||-0.85|-1.29|<0.0001
72550335|NCT06354270|144630728|SUPERIORITY||Adjusted Mean Difference|36.72|STANDARD_ERROR_OF_MEAN|3.319|<|0.0001|TWO_SIDED|95.0|30.14|43.29|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as Test toothpaste minus Reference toothpaste.|||43.29|30.14|<0.0001
72550336|NCT06354270|144630729|SUPERIORITY||Adjusted Mean Difference|-0.62|STANDARD_ERROR_OF_MEAN|0.083|<|0.0001|TWO_SIDED|95.0|-0.79|-0.46|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as Test toothpaste minus Reference toothpaste.|||-0.46|-0.79|<0.0001
72550337|NCT06354270|144630730|SUPERIORITY||Adjusted Mean Difference|14.31|STANDARD_ERROR_OF_MEAN|2.128|<|0.0001|TWO_SIDED|95.0|10.09|18.52|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as Test toothpaste minus Reference toothpaste.|||18.52|10.09|<0.0001
72550338|NCT06354270|144630731|SUPERIORITY||Adjusted Mean Difference|-0.33|STANDARD_ERROR_OF_MEAN|0.252||0.196|TWO_SIDED|95.0|-0.83|0.17|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as Test toothpaste minus Reference toothpaste.|Q7 (How intense are the sensations?): Change from Baseline at Day 28||0.17|-0.83|0.1960
72550339|NCT06354270|144630731|SUPERIORITY||Adjusted Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.344||0.2287|TWO_SIDED|95.0|-1.08|0.28|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as Test toothpaste minus Reference toothpaste.|Q7 (How intense are the sensations?): Change from Baseline at Day 56||0.28|-1.08|0.2287
72550340|NCT06354270|144630731|SUPERIORITY||Adjusted Mean Difference|-0.33|STANDARD_ERROR_OF_MEAN|0.28||0.235|TWO_SIDED|95.0|-0.89|0.22|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as Test toothpaste minus Reference toothpaste.|Q8 (How bothered are you by any sensations?): Change from Baseline at Day 28||0.22|-0.89|0.2350
72550341|NCT06354270|144630731|SUPERIORITY||Adjusted Mean Difference|-0.44|STANDARD_ERROR_OF_MEAN|0.328||0.1818|TWO_SIDED|95.0|-1.09|0.21|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as Test toothpaste minus Reference toothpaste.|Q8 (How bothered are you by any sensations?): Change from Baseline at Day 56||0.21|-1.09|0.1818
72550342|NCT06354270|144630731|SUPERIORITY||Adjusted Mean Difference|-0.54|STANDARD_ERROR_OF_MEAN|0.357||0.1316|TWO_SIDED|95.0|-1.25|0.17|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as Test toothpaste minus Reference toothpaste.|Q9 (How well can you tolerate sensations?): Change from Baseline at Day 28||0.17|-1.25|0.1316
72550343|NCT06354270|144630731|SUPERIORITY||Adjusted Mean Difference|-0.77|STANDARD_ERROR_OF_MEAN|0.417||0.0658|TWO_SIDED|95.0|-1.6|0.05|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as Test toothpaste minus Reference toothpaste.|Q9 (How well can you tolerate sensations?): Change from Baseline at Day 56||0.05|-1.60|0.0658
72550344|NCT06354270|144630732|SUPERIORITY||Adjusted Mean Difference|1.19|STANDARD_ERROR_OF_MEAN|4.862||0.8072|TWO_SIDED|95.0|-8.45|10.83|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as Test toothpaste minus Reference toothpaste.|Change from Baseline at Day 28||10.83|-8.45|0.8072
72550345|NCT06354270|144630732|SUPERIORITY||Adjusted Mean Difference|0.28|STANDARD_ERROR_OF_MEAN|6.175||0.9641|TWO_SIDED|95.0|-11.96|12.52|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as Test toothpaste minus Reference toothpaste.|Change from Baseline at Day 56||12.52|-11.96|0.9641
72550346|NCT06354270|144630733|SUPERIORITY||Adjusted Mean Difference|0.86|STANDARD_ERROR_OF_MEAN|0.75||0.2538|TWO_SIDED|95.0|-0.63|2.35|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as Test toothpaste minus Reference toothpaste.|Change from Baseline at Day 28||2.35|-0.63|0.2538
72550347|NCT06354270|144630733|SUPERIORITY||Adjusted Mean Difference|-0.32|STANDARD_ERROR_OF_MEAN|0.922||0.7311|TWO_SIDED|95.0|-2.15|1.51|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as Test toothpaste minus Reference toothpaste.|Change from Baseline at Day 56||1.51|-2.15|0.7311
72550348|NCT06354270|144630734|SUPERIORITY||Adjusted Mean Difference|0.78|STANDARD_ERROR_OF_MEAN|2.162||0.7202|TWO_SIDED|95.0|-3.51|5.06|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as Test toothpaste minus Reference toothpaste.|Change from Baseline at Day 28||5.06|-3.51|0.7202
72550349|NCT06354270|144630734|SUPERIORITY||Adjusted Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|2.532||0.9859|TWO_SIDED|95.0|-5.06|4.98|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as Test toothpaste minus Reference toothpaste.|Change from Baseline at Day 56||4.98|-5.06|0.9859
72550350|NCT06354270|144630735|SUPERIORITY||Adjusted Mean Difference|-0.46|STANDARD_ERROR_OF_MEAN|0.78||0.5586|TWO_SIDED|95.0|-2.0|1.09|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as Test toothpaste minus Reference toothpaste.|Change from Baseline at Day 28||1.09|-2.00|0.5586
72550351|NCT06354270|144630735|SUPERIORITY||Adjusted Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.961||0.873|TWO_SIDED|95.0|-2.06|1.75|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as Test toothpaste minus Reference toothpaste.|Change from Baseline at Day 56||1.75|-2.06|0.8730
72550352|NCT06354270|144630736|SUPERIORITY||Adjusted Mean Difference|-0.69|STANDARD_ERROR_OF_MEAN|1.383||0.6191|TWO_SIDED|95.0|-3.43|2.05|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as Test toothpaste minus Reference toothpaste.|Change from Baseline at Day 28||2.05|-3.43|0.6191
72550353|NCT06354270|144630736|SUPERIORITY||Adjusted Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|1.669||0.9521|TWO_SIDED|95.0|-3.41|3.21|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as Test toothpaste minus Reference toothpaste.|Change from Baseline at Day 56||3.21|-3.41|0.9521
72550354|NCT06354270|144630737|SUPERIORITY||Adjusted Mean Difference|0.69|STANDARD_ERROR_OF_MEAN|0.795||0.3887|TWO_SIDED|95.0|-0.89|2.26|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as Test toothpaste minus Reference toothpaste.|Change from Baseline at Day 28||2.26|-0.89|0.3887
72550355|NCT06354270|144630737|SUPERIORITY||Adjusted Mean Difference|0.88|STANDARD_ERROR_OF_MEAN|0.989||0.373|TWO_SIDED|95.0|-1.08|2.84|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as Test toothpaste minus Reference toothpaste.|Change from Baseline at Day 56||2.84|-1.08|0.3730
72550356|NCT06354270|144630738|SUPERIORITY||Adjusted Mean Difference|0.19|STANDARD_ERROR_OF_MEAN|0.134||0.1591|TWO_SIDED|95.0|-0.08|0.46|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as Test toothpaste minus Reference toothpaste.|Change from Baseline at Day 28||0.46|-0.08|0.1591
72550357|NCT06354270|144630738|SUPERIORITY||Adjusted Mean Difference|0.14|STANDARD_ERROR_OF_MEAN|0.144||0.3429|TWO_SIDED|95.0|-0.15|0.42|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as Test toothpaste minus Reference toothpaste.|Change from Baseline at Day 56||0.42|-0.15|0.3429
72550358|NCT06354270|144630739|SUPERIORITY||Adjusted Mean Difference|-0.62|STANDARD_ERROR_OF_MEAN|0.411||0.136|TWO_SIDED|95.0|-1.43|0.2|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as Test toothpaste minus Reference toothpaste.|Change from Baseline at Day 28||0.20|-1.43|0.1360
72550359|NCT06354270|144630739|SUPERIORITY||Adjusted Mean Difference|-0.46|STANDARD_ERROR_OF_MEAN|0.431||0.2914|TWO_SIDED|95.0|-1.31|0.4|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as Test toothpaste minus Reference toothpaste.|Change from Baseline at Day 56||0.40|-1.31|0.2914
72550360|NCT01939197|144630740|NON_INFERIORITY|The primary efficacy endpoint was the non-inferiority of the percentage of participants in the GT1 Analysis Group in Part 2 achieving SVR12 compared to the historical SVR12 rate for sofosbuvir plus ribavirin (a non-inferiority threshold of the lower bound of the 95% CI of 74%).|||||||||||||||||"The historical SVR rate, as reported in the PHOTON-1 study, for sofosbuvir and RBV in HCV/HIV-1 coinfected adults is 76% (87/114) with a 95% confidence interval of (67%, 84%).~Reference: Sulkowski MS, Naggie S, Lalezari J, et al. Sofosbuvir and ribavirin for hepatitis C in patients with HIV coinfection. JAMA. 2014;312(4):353-61."|||
72550361|NCT01939197|144630741|OTHER|||||||1|||||||Fisher Exact|||||||1.000
72550362|NCT01939197|144630742|OTHER||||||||||||||||||"The Fisher exact test was performed as prespecified on the SAP but the p-value couldn't be calculated because SVR12 rates in both arms were 100%, hence p-value appeared as not available."|||
72550363|NCT01968382|144630791|SUPERIORITY|||||||0.3198|||||||ANOVA|||||||0.3198
72550364|NCT01968382|144630794|SUPERIORITY|||||||0.8462|||||||ANOVA|||||||0.8462
72550365|NCT00113425|144630803|SUPERIORITY_OR_OTHER|||||||0.01|TWO_SIDED|95.0|||||paired t-test, 2-sided|||Null Hypothesis = There is no difference between change from baseline in papule acne lesions for the treated side of the face compared to the change from baseline for the untreated side of the face in all patients||||0.01
72550366|NCT00113425|144630804|SUPERIORITY_OR_OTHER|||||||0.43|||||||paired t-test, 2-sided|||Null Hypothesis = There is no difference between change from baseline in pustule acne lesions for the treated side of the face compared to the change from baseline for the untreated side of the face in all patients||||0.43
72550367|NCT00113425|144630805|SUPERIORITY_OR_OTHER|||||||0.79|||||||paired t-test, 2-sided|||Null Hypothesis = There is no difference between change from baseline in cysts for the treated side of the face compared to the change from baseline for the untreated side of the face in all patients||||0.79
72550368|NCT00113425|144630806|SUPERIORITY_OR_OTHER|||||||0.1|||||||paired t-test, 2-sided|||Null Hypothesis = There is no difference between change from baseline in closed comedones for the treated side of the face compared to the change from baseline for the untreated side of the face in all patients||||0.10
72550369|NCT00113425|144630807|SUPERIORITY_OR_OTHER|||||||0.73|||||||paired t-test, 2-sided|||Null Hypothesis = There is no difference between change from baseline in open comedones for the treated side of the face compared to the change from baseline for the untreated side of the face in all patients||||0.73
72550370|NCT00113425|144630808|SUPERIORITY_OR_OTHER|||||||0.02|||||||paired t-test, 2-sided|||Null Hypothesis = There is no difference between change from baseline in erythematous macules for the treated side of the face compared to the change from baseline for the untreated side of the face in all patients||||0.02
72550371|NCT00113425|144630809|SUPERIORITY_OR_OTHER|||||||0.003|||||||paired t-test, 2-sided|||Null Hypothesis = There is no difference between change from baseline in acne severity for the treated side of the face compared to the change from baseline for the untreated side of the face in all patients||||0.003
72550372|NCT00113425|144630810|SUPERIORITY_OR_OTHER|||||||0.62|||||||paired t-test, 2-sided|||Null Hypothesis = There is no difference between change from baseline in papule acne lesions for the treated side of the face compared to the change from baseline for the untreated side of the face in all patients||||0.62
72550373|NCT00113425|144630811|SUPERIORITY_OR_OTHER|||||||0.85|||||||paired t-test, 2-sided|||Null Hypothesis = There is no difference between change from baseline in pustule acne lesions for the treated side of the face compared to the change from baseline for the untreated side of the face in all patients||||0.85
72550374|NCT00113425|144630812|SUPERIORITY_OR_OTHER|||||||0.49|||||||paired t-test, 2-sided|||Null Hypothesis = There is no difference between change from baseline in cysts for the treated side of the face compared to the change from baseline for the untreated side of the face in all patients||||0.49
72550375|NCT00113425|144630813|SUPERIORITY_OR_OTHER|||||||0.21|||||||paired t-test, 2-sided|||Null Hypothesis = There is no difference between change from baseline in closed comedones for the treated side of the face compared to the change from baseline for the untreated side of the face in all patients||||0.21
72550376|NCT00113425|144630814|SUPERIORITY_OR_OTHER|||||||0.27|||||||paired t-test, 2-sided|||Null Hypothesis = There is no difference between change from baseline in open comedones for the treated side of the face compared to the change from baseline for the untreated side of the face in all patients||||0.27
72550377|NCT00113425|144630815|SUPERIORITY_OR_OTHER|||||||0.04|||||||paired t-test, 2-sided|||Null Hypothesis = There is no difference between change from baseline in erythematous macules for the treated side of the face compared to the change from baseline for the untreated side of the face in all patients||||0.04
72550378|NCT00113425|144630816|SUPERIORITY_OR_OTHER|||||||0.01|||||||paired t-test, 2-sided|||Null Hypothesis = There is no difference between change from baseline in acne severity for the treated side of the face compared to the change from baseline for the untreated side of the face in all patients||||0.01
72550379|NCT00406848|144630889|SUPERIORITY_OR_OTHER|||||||0.397||95.0||||The a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change = Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||Tested was the null hypothesis that there would be no difference in changes from baseline (Week 1) to Week 13 on the HAMD-17 Maier subscale between duloxetine and placebo treatment groups.||||0.397
72550380|NCT00406848|144630890|SUPERIORITY_OR_OTHER|||||||0.115||95.0||||p-value is for difference between duloxetine and placebo on change from baseline (Week 1) to Week 13.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change = Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||0.115
72550381|NCT00406848|144630890|SUPERIORITY_OR_OTHER|||||||0.004||95.0||||p-value is for difference between duloxetine and placebo on change from baseline (Week 1) to Week 25.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change = Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||0.004
72550382|NCT00406848|144630891|SUPERIORITY_OR_OTHER|||||||0.773||95.0||||p-value is for HAMD-17 total score change from baseline (Week 1) to Week 13.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change = Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||0.773
72550383|NCT00406848|144630891|SUPERIORITY_OR_OTHER|||||||0.084||95.0||||p-value is for HAMD-17 total score change from baseline (Week 1) to Week 25.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||0.084
72550384|NCT00406848|144630891|SUPERIORITY_OR_OTHER|||||||0.059||95.0||||p-value is for Maier subscale change from baseline (Week 1) to Week 25.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||0.059
72550385|NCT00406848|144630891|SUPERIORITY_OR_OTHER|||||||0.488||95.0||||p-value is for Bech subscale change from baseline (Week 1) to Week 13.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||0.488
72550386|NCT00406848|144630891|SUPERIORITY_OR_OTHER|||||||0.048||95.0||||p-value is for HAMD-17 Bech subscale change from baseline (Week 1) to Week 25.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||0.048
72550387|NCT00406848|144630891|SUPERIORITY_OR_OTHER|||||||0.529||95.0||||p-value is for Core Mood subscale change from baseline (Week 1) to Week 13.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||0.529
72550388|NCT00406848|144630891|SUPERIORITY_OR_OTHER|||||||0.027||95.0||||p-value is for Core Mood subscale change from baseline (Week 1) to Week 25.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||0.027
72550389|NCT00406848|144630891|SUPERIORITY_OR_OTHER|||||||0.749||95.0||||p-value is for Anxiety/Somatization subscale change from baseline (Week 1) to Week 13.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||0.749
72550390|NCT00406848|144630891|SUPERIORITY_OR_OTHER|||||||0.296||95.0||||p-value is for Anxiety/Somatization subscale change from baseline (Week 1) to Week 25.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||0.296
72550391|NCT00406848|144630891|SUPERIORITY_OR_OTHER|||||||0.984||95.0||||p-value is for Sleep subscale change from baseline (Week 1) to Week 13.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||0.984
72550392|NCT00406848|144630891|SUPERIORITY_OR_OTHER|||||||0.93||95.0||||p-value is for Sleep subscale change from baseline (Week 1) to Week 25.|Mixed Models Analysis|Change = Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||0.930
72550393|NCT00406848|144630891|SUPERIORITY_OR_OTHER|||||||0.934||95.0||||p-value is for Retardation subscale change from baseline (Week 1) to Week 13.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||0.934
72550394|NCT00406848|144630891|SUPERIORITY_OR_OTHER|||||||0.123||95.0||||p-value is for Retardation subscale change from baseline (Week 1) to Week 25.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||0.123
72550395|NCT00406848|144630892|SUPERIORITY_OR_OTHER|||||||0.034||95.0||||p-value is for Severity of Worst Pain Week 13 main effect of treatment.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||0.034
72550396|NCT00406848|144630892|SUPERIORITY_OR_OTHER|||||||0.1||95.0||||p-value is for Severity of Worst Pain - Week 25 main effect of treatment.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||0.100
72550397|NCT00406848|144630892|SUPERIORITY_OR_OTHER|||||||0.009||95.0||||p-value is for Severity of Least Pain Week 13 main effect of treatment.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||0.009
72550398|NCT00406848|144630892|SUPERIORITY_OR_OTHER|||||||0.126||95.0||||p-value is for Severity of Least Pain Week 25 main effect of treatment.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||0.126
72550399|NCT00406848|144630892|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value is for Severity of Average Pain Week 13 main effect of treatment.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||<0.001
72550400|NCT00406848|144630892|SUPERIORITY_OR_OTHER|||||||0.013||95.0||||p-value is for Severity of Average Pain Week 25 main effect of treatment.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||0.013
72550401|NCT00406848|144630892|SUPERIORITY_OR_OTHER|||||||0.016||95.0||||p-value is for Severity of Pain Right Now Week 13 main effect of treatment.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||0.016
72550402|NCT00406848|144630892|SUPERIORITY_OR_OTHER|||||||0.058||95.0||||p-value is for Severity of Pain Right Now Week 25 main effect of treatment.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||0.058
72550403|NCT00406848|144630892|SUPERIORITY_OR_OTHER|||||||0.011||95.0||||p-value is for Interference with General Activity Week 13 main effect of treatment.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||0.011
72550404|NCT00406848|144630892|SUPERIORITY_OR_OTHER|||||||0.06||95.0||||p-value is for Interference with General Activity Week 25 main effect of treatment.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||0.060
72412851|NCT02328326|144334025|SUPERIORITY||Mean Difference (Net)|0.17||||0.33|TWO_SIDED|95.0|-0.17|0.51|||Regression, Linear|Model was adjusted for baseline value of A1c, insulin use, randomization stratification variables: care partner not in home and PAM cutoff of 40|Net difference defined as 12 months minus baseline|The null hypothesis was that change (baseline to 12 months) in A1c is the same for CO-IMPACT (intervention) compared to PACT (control). The alternative hypothesis is that that COIMPACT will significantly decrease patient participants' A1c score compared to patient participants in PACT.||0.51|-0.17|0.33
72412852|NCT02328326|144334026|SUPERIORITY||Mean Difference (Net)|-2.82||||0.18|TWO_SIDED|95.0|-7.0|1.35|||Regression, Linear|Model was adjusted for baseline value of SBP, insulin use, randomization stratification variables: care partner not in home and PAM cutoff of 40.|Net difference defined as 12 months minus baseline|The null hypothesis was that change (baseline to 12 months) in SBP is the same for CO-IMPACT (intervention) compared to PACT (control). The alternative hypothesis is that that COIMPACT will significantly decrease patient participants' SBP score compared to patient participants in PACT.||1.35|-7.00|0.18
72412853|NCT02328326|144334027|SUPERIORITY||Mean Difference (Net)|0.12||||0.83|TWO_SIDED|95.0|-0.95|1.19|||Regression, Linear|Model was adjusted for baseline value of PAID, insulin use, randomization stratification variables: care partner not in home and PAM cutoff of 40|Net difference defined as 12 months minus baseline|The null hypothesis was that change (baseline to 12 months) in PAID is the same for CO-IMPACT (intervention) compared to PACT (control). The alternative hypothesis is that that COIMPACT will significantly increase patient participants' PAID score compared to patient participants in PACT.||1.19|-0.95|0.83
72412854|NCT02328326|144334028|SUPERIORITY||Mean Difference (Net)|0.11||||0.79|TWO_SIDED|95.0|-0.71|0.93|||Regression, Linear|Model was adjusted for baseline value of PEPPI, insulin use, randomization stratification variables: care partner not in home and PAM cutoff of 40|Net difference defined as 12 months minus baseline|The null hypothesis was that change (baseline to 12 months) in PEPPI is the same for CO-IMPACT (intervention) compared to PACT (control). The alternative hypothesis is that that COIMPACT will significantly increase patient participants' PEPPI score compared to patient participants in PACT.||0.93|-0.71|0.79
72412855|NCT02328326|144334029|SUPERIORITY||Median Difference (Net)|0.15||||0.21|TWO_SIDED|95.0|-0.09|0.4|||Regression, Linear|Model adjusted for BL value of Cho to HDL Ratio, insulin use, randomization stratification variables: care partner not in home and PAM cutoff of 40.|Net difference defined as 12 months minus baseline|The null hypothesis was that change (baseline to 12 months) in Chol to HDL Ratio is the same for CO-IMPACT (intervention) compared to PACT (control). The alternative hypothesis is that that COIMPACT will significantly decrease patient participants' Chol to HDL Ratio score compared to patient participants in PACT.||0.40|-0.09|0.21
72412856|NCT02328326|144334031|SUPERIORITY||Mean Difference (Net)|0.3||||0.01|TWO_SIDED|95.0|0.08|0.53|||Regression, Linear|Model was adjusted for baseline value of IOCQ, insulin use, randomization stratification variables: care partner not in home and PAM cutoff of 40|Net difference defined as 12 months minus baseline|The null hypothesis was that change (baseline to 12 months) in IOCQ is the same for CO-IMPACT (intervention) compared to PACT (control). The alternative hypothesis is that that COIMPACT will significantly increase patient participants' IOCQ score compared to patient participants in PACT.||0.53|0.08|0.01
72550405|NCT00406848|144630892|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value is for Interference with Mood Week 13 main effect of treatment.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||<0.001
72412857|NCT02328326|144334032|EQUIVALENCE|Equivalent distribution among categories|difference in count|-1.0||||0.17|TWO_SIDED||||||Chi-squared||||Difference in count of those who stopped smoking in CO-IMPACT vs. those who stopped smoking in PACT.|||0.17
72550406|NCT00406848|144630892|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||p-value is for Interference with Mood Week 25 main effect of treatment.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||0.002
72550407|NCT00406848|144630892|SUPERIORITY_OR_OTHER|||||||0.019||95.0||||p-value is for Interference with Walking Ability Week 13 main effect of treatment.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||0.019
72550408|NCT00406848|144630892|SUPERIORITY_OR_OTHER|||||||0.04||95.0||||p-value is for Interference with Walking Ability Week 25 main effect of treatment.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||0.040
72583265|NCT01268527|144697256|SUPERIORITY||Difference in LSM (vehicle - E6201 gel)|1119.8|||<|0.0001|TWO_SIDED|95.0|858.9|1380.6|||ANCOVA|||The following hypotheses were based on the Full Analysis Population: null Hypothesis and alternative hypothesis. P values, LSM, and CI were obtained from ANCOVA model with factors for treatment and baseline psoriatic infiltrate thickness as a continuous covariate.||1380.6|858.9|<0.0001
72412858|NCT02328326|144334033|SUPERIORITY||Mean Difference (Net)|-0.04||||0.87|TWO_SIDED|95.0|-0.56|0.47|||Regression, Linear|Model adjusted for BL value of Physical Activity, insulin use, randomization stratification variables: care partner not in home and PAM cutoff of 40|Net difference defined as 12 months minus baseline|The null hypothesis was that change (baseline to 12 months) in Physical activity is the same for CO-IMPACT (intervention) compared to PACT (control). The alternative hypothesis is that that COIMPACT will significantly increase patient participants' Physical activity score compared to patient participants in PACT.||0.47|-0.56|0.87
72550409|NCT00406848|144630892|SUPERIORITY_OR_OTHER|||||||0.003||95.0||||p-value is for Interference with Normal Work Week 13 main effect of treatment.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||0.003
72583266|NCT01268527|144697256|SUPERIORITY||Difference in LSM (vehicle - E6201 gel)|780.0||||0.0523|TWO_SIDED|95.0|-8.5|1568.5|||ANCOVA|||The following hypotheses were based on the Full Analysis Population: null Hypothesis and alternative hypothesis. P values, LSM, and CI were obtained from ANCOVA model with factors for treatment and baseline psoriatic infiltrate thickness as a continuous covariate.||1568.5|-8.5|0.0523
72550410|NCT00406848|144630892|SUPERIORITY_OR_OTHER|||||||0.014||95.0||||p-value is for Interference with Normal Work Week 25 main effect of treatment.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||0.014
72550411|NCT00406848|144630892|SUPERIORITY_OR_OTHER|||||||0.01||95.0||||p-value is for Interference with Relations with Other People Week 13 main effect of treatment.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||0.010
72550412|NCT00406848|144630892|SUPERIORITY_OR_OTHER|||||||0.01||95.0||||p-value is for Interference with Relations with Other People Week 25 main effect of treatment.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||0.010
72550413|NCT00406848|144630892|SUPERIORITY_OR_OTHER|||||||0.015||95.0||||p-value is for Interference with Sleep Week 13 main effect of treatment.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||0.015
72583267|NCT01268527|144697256|SUPERIORITY||Difference in LSM (vehicle - E6201 gel)|1775.1|||<|0.0001|TWO_SIDED|95.0|1392.3|2158.0|||ANCOVA|||The following hypotheses were based on the Full Analysis Population: null Hypothesis and alternative hypothesis. P values, LSM, and CI were obtained from ANCOVA model with factors for treatment and baseline psoriatic infiltrate thickness as a continuous covariate.||2158.0|1392.3|<0.0001
72583268|NCT01268527|144697256|SUPERIORITY||Difference in LSM (vehicle - E6201 gel)|921.4||||0.0002|TWO_SIDED|95.0|515.7|1327.1|||ANCOVA|||The following hypotheses were based on the Full Analysis Population: null Hypothesis and alternative hypothesis. P values, LSM, and CI were obtained from ANCOVA model with factors for treatment and baseline psoriatic infiltrate thickness as a continuous covariate.||1327.1|515.7|0.0002
72583269|NCT01268527|144697256|SUPERIORITY||Difference in LSM (vehicle - E6201 gel)|937.8||||0.0115|TWO_SIDED|95.0|267.6|1607.9|||ANCOVA|||The following hypotheses were based on the Full Analysis Population: null Hypothesis and alternative hypothesis. P values, LSM, and CI were obtained from ANCOVA model with factors for treatment and baseline psoriatic infiltrate thickness as a continuous covariate.||1607.9|267.6|0.0115
72550414|NCT00406848|144630892|SUPERIORITY_OR_OTHER|||||||0.005||95.0||||p-value is for Interference with Sleep Week 25 main effect of treatment.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||0.005
72550415|NCT00406848|144630892|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value is for Interference with Enjoyment of Life Week 13 main effect of treatment.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||<0.001
72550416|NCT00406848|144630892|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value is for Interference with Enjoyment of Life Week 25 main effect of treatment.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||<0.001
72550417|NCT00406848|144630892|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value is for Average Interference Score Week 13 main effect of treatment.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||<0.001
72550418|NCT00406848|144630892|SUPERIORITY_OR_OTHER|||||||0.001||95.0||||p-value is for Average Interference Score Week 25 main effect of treatment.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||0.001
72550419|NCT00406848|144630893|SUPERIORITY_OR_OTHER|||||||0.005||95.0||||p-value is for Overall Pain Week 13 main effect of treatment.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||.005
72550420|NCT00406848|144630893|SUPERIORITY_OR_OTHER|||||||0.204||95.0||||p-value is for Overall Pain Week 25 main effect of treatment.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||0.204
72583270|NCT01268527|144697257|SUPERIORITY||Difference in LSM (vehicle - E6201 gel)|101.5||||0.0042|TWO_SIDED|95.0|36.0|167.0|||ANCOVA|||The following hypotheses were based on the Full Analysis Population: null Hypothesis and alternative hypothesis. P values, LSM, and CI were obtained from ANCOVA model with factors for treatment and baseline psoriatic infiltrate thickness as a continuous covariate.||167.0|36.0|0.0042
72412859|NCT02328326|144334034|SUPERIORITY||Mean Difference (Net)|0.23||||0.31|TWO_SIDED|95.0|-0.22|0.68|||Regression, Linear|Model adjusted for BL value of Blood Sugar Home Testing, insulin use, randomization strat. variables: care partner not in home and PAM cutoff of 40|Net difference defined as 12 months minus baseline|The null hypothesis was that change (baseline to 12 months) in Blood Sugar Home Testing is the same for CO-IMPACT (intervention) compared to PACT (control). The alternative hypothesis is that that COIMPACT will significantly increase patient participants' Blood Sugar Home Testing score compared to patient participants in PACT.||0.68|-0.22|0.31
72412860|NCT02328326|144334035|SUPERIORITY||Mean Difference (Net)|0.07||||0.87|TWO_SIDED|95.0|-0.76|0.89|||Regression, Linear|Model adjusted for BL value of Blood Pressure Home Testing, insulin use, randomization strat. variables: care partner not in home and PAM cutoff of 40|Net difference defined as 12 months minus baseline|The null hypothesis was that change (baseline to 12 months) in Blood Pressure Home Testing is the same for CO-IMPACT (intervention) compared to PACT (control). The alternative hypothesis is that that COIMPACT will significantly increase patient participants' Blood Pressure Home Testing score compared to patient participants in PACT.||0.89|-0.76|0.87
72412861|NCT02328326|144334036|SUPERIORITY||Mean Difference (Net)|-0.1||||0.56|TWO_SIDED|95.0|-0.42|0.23|||Regression, Linear|Model adjusted for BL value of Take Oral Meds as Prescribed, insulin use, randomization strat variables: care partner not in home and PAM cutoff of 40|Net difference defined as 12 months minus baseline|The null hypothesis was that change (baseline to 12 months) in Take Oral Meds as Prescribed is the same for CO-IMPACT (intervention) compared to PACT (control). The alternative hypothesis is that that COIMPACT will significantly increase patient participants' Take Oral Meds as Prescribed score compared to patient participants in PACT.||0.23|-0.42|0.56
72412862|NCT02328326|144334037|SUPERIORITY||Mean Difference (Net)|0.07||||0.67|TWO_SIDED|95.0|-0.26|0.41|||Regression, Linear|Model adjusted for baseline value of Take Insulin as Prescribed, randomization stratification variables: care partner not in home and PAM cutoff of 40|Net difference defined as 12 months minus baseline|The null hypothesis was that change (baseline to 12 months) in Take Insulin as prescribed is the same for CO-IMPACT (intervention) compared to PACT (control). The alternative hypothesis is that that COIMPACT will significantly increase patient participants' Take Insulin as Prescribed compared to patient participants in PACT.||0.41|-0.26|0.67
72412863|NCT02328326|144334038|SUPERIORITY|The null hypothesis was that change (baseline to 12 months) in Foot Care is the same for CO-IMPACT (intervention) compared to PACT (control). The alternative hypothesis is that that COIMPACT will significantly increase patient participants' Foot Care score compared to patient participants in PACT.|Median Difference (Net)|0.26||||0.29|TWO_SIDED|95.0|-0.22|0.75|||Regression, Linear|Model was adjusted for baseline value of Foot Care, insulin use, randomization stratification variables: care partner not in home and PAM cutoff of 40|||Net difference defined as 12 months minus baseline|0.75|-0.22|0.29
72550421|NCT00406848|144630893|SUPERIORITY_OR_OTHER|||||||0.078||95.0||||p-value is for Headaches Week 13 main effect of treatment.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||0.078
72550422|NCT00406848|144630893|SUPERIORITY_OR_OTHER|||||||0.147||95.0||||p-value is for Headaches Week 25 main effect of treatment.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||0.147
72550423|NCT00406848|144630893|SUPERIORITY_OR_OTHER|||||||0.007||95.0||||p-value is for Back Pain Week 13 main effect of treatment.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||0.007
72550424|NCT00406848|144630893|SUPERIORITY_OR_OTHER|||||||0.013||95.0||||p-value is for Back Pain Week 25 main effect of treatment.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||0.013
72550425|NCT00406848|144630893|SUPERIORITY_OR_OTHER|||||||0.124||95.0||||p-value is for Shoulder Pain Week 13 main effect of treatment.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||0.124
72550426|NCT00406848|144630893|SUPERIORITY_OR_OTHER|||||||0.231||95.0||||p-value is for Shoulder Pain Week 25 main effect of treatment.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||0.231
72550427|NCT00406848|144630893|SUPERIORITY_OR_OTHER|||||||0.006||95.0||||p-value is for Interference with Daily Activities Week 13 main effect of treatment.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||0.006
72550428|NCT00406848|144630893|SUPERIORITY_OR_OTHER|||||||0.019||95.0||||p-value is for Interference with Daily Activities Week 25 main effect of treatment.|Mixed Models Analysis|Change = Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit||||||0.019
72583271|NCT01268527|144697257|SUPERIORITY||Difference in LSM (vehicle - E6201 gel)|182.4|||<|0.0001|TWO_SIDED|95.0|140.3|224.4|||ANCOVA|||The following hypotheses were based on the Full Analysis Population: null Hypothesis and alternative hypothesis. P values, LSM, and CI were obtained from ANCOVA model with factors for treatment and baseline psoriatic infiltrate thickness as a continuous covariate.||224.4|140.3|<0.0001
72583272|NCT01268527|144697257|SUPERIORITY||Difference in LSM (vehicle - E6201 gel)|169.5|||<|0.0001|TWO_SIDED|95.0|127.4|211.5|||ANCOVA|||The following hypotheses were based on the Full Analysis Population: null Hypothesis and alternative hypothesis. P values, LSM, and CI were obtained from ANCOVA model with factors for treatment and baseline psoriatic infiltrate thickness as a continuous covariate.||211.5|127.4|<0.0001
72583273|NCT01268527|144697257|SUPERIORITY||Difference in LSM (vehicle - E6201 gel)|246.6|||<|0.0001|TWO_SIDED|95.0|185.0|308.1|||ANCOVA|||The following hypotheses were based on the Full Analysis Population: null Hypothesis and alternative hypothesis. P values, LSM, and CI were obtained from ANCOVA model with factors for treatment and baseline psoriatic infiltrate thickness as a continuous covariate.||308.1|185.0|<0.0001
72550429|NCT00406848|144630893|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||p-value is for Time in Pain While Awake Week 13 main effect of treatment.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||0.002
72412864|NCT02328326|144334039|SUPERIORITY||Mean Difference (Net)|0.4||||0.01|TWO_SIDED|95.0|0.09|0.71|||Regression, Linear|Model was adjusted for baseline value of SE, insulin use, randomization stratification variables: care partner not in home and PAM cutoff of 40|Net difference defined as 12 months minus baseline|The null hypothesis was that change (baseline to 12 months) in SE is the same for CO-IMPACT (intervention) compared to PACT (control). The alternative hypothesis is that that COIMPACT will significantly change patient participants' SE scores compared to patient participants in PACT.||0.71|0.09|0.01
72412865|NCT02328326|144334040|SUPERIORITY||Mean Difference (Net)|0.1||||0.67|TWO_SIDED|95.0|-0.34|0.55|||Regression, Linear|Model was adjusted for baseline value of Lorig\_CP, insulin use, randomization stratification variables: care partner not in home and PAM cutoff of 40|Net difference defined as 12 months minus baseline|The null hypothesis was that change (baseline to 12 months) in Lorig\_CP is the same for CO-IMPACT (intervention) compared to PACT (control). The alternative hypothesis is that that COIMPACT will significantly increase patient participants' Lorig\_CP score compared to patient participants in PACT.||0.55|-0.34|0.67
72550430|NCT00406848|144630893|SUPERIORITY_OR_OTHER|||||||0.036||95.0||||p-value is for Time in Pain While Awake Week 25 main effect of treatment.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||0.036
72550431|NCT00406848|144630894|SUPERIORITY_OR_OTHER|||||||0.214||95.0||||p-value is for PGI-I at Week 13.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: PGI-I = Treatment + Pooled Investigator + Visit + Treatment\* Visit||||||0.214
72550432|NCT00406848|144630894|SUPERIORITY_OR_OTHER|||||||0.063||95.0||||p-value is for PGI-I at Week 25.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: PGI-I = Treatment + Pooled Investigator + Visit + Treatment\* Visit||||||.063
72550433|NCT00406848|144630895|SUPERIORITY_OR_OTHER|||||||0.162||95.0||||p-value is for change from baseline (Week 1) to Week 13.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||.162
72550434|NCT00406848|144630895|SUPERIORITY_OR_OTHER|||||||0.009||95.0||||p-value is for change from baseline (Week 1) to Week 25.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||.009
72550435|NCT00406848|144630896|SUPERIORITY_OR_OTHER|||||||0.555||95.0||||p-value is for change from baseline (Week 1) to Week 9.|ANCOVA|Model: Change = Treatment + Pooled Investigator + Baseline||||||0.555
72550436|NCT00406848|144630896|SUPERIORITY_OR_OTHER|||||||0.785||95.0||||p-value is for change from baseline (Week 1) to Week 25.|ANCOVA|Model: Change = Treatment + Pooled Investigator + Baseline||||||.785
72550437|NCT00406848|144630897|SUPERIORITY_OR_OTHER|||||||0.255||95.0||||p-value is for change from baseline (Week 1) to Week 13.|ANCOVA|Model: Change = Treatment + Pooled Investigator + Baseline||||||0.255
72550438|NCT00406848|144630897|SUPERIORITY_OR_OTHER|||||||0.038||95.0||||p-value is for change from baseline (Week 1) to Week 25.|ANCOVA|Model: Change = Treatment + Pooled Investigator + Baseline||||||0.038
72550439|NCT00406848|144630898|SUPERIORITY_OR_OTHER|||||||0.706||95.0||||p-values for Week 13 remission (HAMD17 ≤ 7).|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Remission = Treatment + Pooled Investigator + Visit + Baseline + Treatment\*Visit.||||||0.706
72550440|NCT00406848|144630898|SUPERIORITY_OR_OTHER|||||||0.694||95.0||||p-values for Week 25 Remission HAMD17 ≤ 7|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)analysis model:Remission = Treatment + Pooled Investigator + Visit + Baseline + Treatment\*Visit.||||||0.694
72550441|NCT00406848|144630898|SUPERIORITY_OR_OTHER|||||||0.864||95.0||||p-values for Week 13 Remission - HAMD17 ≤ 10|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)analysis model:Remission = Treatment + Pooled Investigator + Visit + Baseline + Treatment\*Visit.||||||0.864
72550442|NCT00406848|144630898|SUPERIORITY_OR_OTHER|||||||0.817||95.0||||p-values for Week 25 Remission - HAMD17 ≤ 10|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)analysis model:Remission = Treatment + Pooled Investigator + Visit + Baseline + Treatment\*Visit.||||||0.817
72550443|NCT00406848|144630899|SUPERIORITY_OR_OTHER|||||||0.664||95.0||||p-value is for probability of response at Week 13.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)analysis model:Response = Treatment + Pooled Investigator + Visit + Baseline + Treatment\*Visit.||||||0.664
72550444|NCT00406848|144630899|SUPERIORITY_OR_OTHER|||||||0.31||95.0||||p-value is for probability of response at Week 25.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)analysis model:Response = Treatment + Pooled Investigator + Visit + Baseline + Treatment\*Visit.||||||0.310
72550445|NCT00406848|144630901|SUPERIORITY_OR_OTHER|||||||0.036||95.0|||||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)analysis model: Onset = Treatment + Visit + Baseline + Treatment\*Visit.||||||0.036
72550446|NCT00406848|144630902|SUPERIORITY_OR_OTHER|||||||0.637||95.0||||p-value is for Systolic BP change from baseline (Week 1) to Week 13.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change = Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||0.637
72550447|NCT00406848|144630902|SUPERIORITY_OR_OTHER|||||||0.001||95.0||||p-value is for Diastolic BP change from baseline (Week 1) to Week 13.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change = Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||0.001
72550448|NCT00406848|144630902|SUPERIORITY_OR_OTHER|||||||0.452||95.0||||p-value is for Systolic BP change from baseline (Week 1) to Week 25.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change = Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||0.452
72412866|NCT02328326|144334041|SUPERIORITY||Mean Difference (Net)|0.28||||0.53|TWO_SIDED|95.0|-0.6|1.16|||Regression, Linear||Net difference defined as 12 months minus baseline|The null hypothesis was that change (baseline to 12 months) in CSIS is the same for CO-IMPACT (intervention) compared to PACT (control). The alternative hypothesis is that that COIMPACT will significantly increase patient participants' CSIS score compared to patient participants in PACT.||1.16|-0.60|0.53
72550449|NCT00406848|144630902|SUPERIORITY_OR_OTHER|||||||0.193||95.0||||p-value is for Diastolic BP change from baseline (Week 1) to Week 25.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change = Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||0.193
72550450|NCT00406848|144630903|SUPERIORITY_OR_OTHER|||||||0.121||95.0||||p-value is for change from baseline (Week 1) to Week 13.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change = Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||0.121
72550451|NCT00406848|144630903|SUPERIORITY_OR_OTHER|||||||0.038||95.0||||p-value is for change from baseline (Week 1) to Week 25.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change = Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||0.038
72550452|NCT00406848|144630904|SUPERIORITY_OR_OTHER|||||||0.003||95.0||||p-value is for Weight change from baseline (Week 1) to Week 13.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change = Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||0.003
72550453|NCT00406848|144630904|SUPERIORITY_OR_OTHER|||||||0.127||95.0||||p-value is for Weight change from baseline (Week 1) to Week 25.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change = Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||0.127
72550454|NCT00406848|144630905|SUPERIORITY_OR_OTHER|||||||0.135||95.0||||p-value is for Diastolic Blood Pressure.|Fisher Exact|||||||0.135
72550455|NCT00406848|144630905|SUPERIORITY_OR_OTHER|||||||1||95.0||||p-value is for Pulse.|Fisher Exact|||Pulse||||1.00
72550456|NCT00406848|144630905|SUPERIORITY_OR_OTHER|||||||0.107||95.0||||p-value is for Systolic Blood Pressure|Fisher Exact|||||||0.107
72550457|NCT00406848|144630905|SUPERIORITY_OR_OTHER|||||||0.235||95.0||||p-value is for Weight Change (gain)|Fisher Exact|||||||0.235
72550458|NCT00406848|144630905|SUPERIORITY_OR_OTHER|||||||0.813||95.0||||p-value is for Weight Change (loss)|Fisher Exact|||||||0.813
72550459|NCT00406848|144630906|SUPERIORITY_OR_OTHER|||||||0.668||95.0||||p-value is for Sustained Hypertension|Fisher Exact|||||||0.668
72550460|NCT00406848|144630906|SUPERIORITY_OR_OTHER|||||||0.201||95.0||||p-value is for Orthostatic Hypotension|Fisher Exact|||||||0.201
72550461|NCT00406848|144630908|SUPERIORITY_OR_OTHER|||||||0.003||95.0||||p-value is for Platelet Count change from baseline (Week 1) to Week 13.|ANOVA|Model: Change=Treatment+Pooled Investigator||||||0.003
72550462|NCT00406848|144630908|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value is for Platelet Count change from baseline (Week 1) to Week 25.|ANOVA|Model: Change=Treatment+Pooled Investigator||||||<0.001
72550463|NCT00406848|144630909|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value is for Uric Acid change from baseline (Week 1) to Week 13.|ANOVA|Model: Change = Treatment + Pooled Investigator||||||<0.001
72550464|NCT00406848|144630909|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value is for Uric Acid change from baseline (Week 1) to Week 25.|ANOVA|Model: Change = Treatment + Pooled Investigator||||||<0.001
72550465|NCT00406848|144630910|SUPERIORITY_OR_OTHER|||||||0.014||95.0||||p-value is for Erythrocyte Count change from baseline (Week 1) to Week 25.|ANOVA|Model: Change=Treatment+Pooled Investigator||||||0.014
72550466|NCT00406848|144630911|SUPERIORITY_OR_OTHER|||||||0.019||95.0||||p-value is for Hemoglobin change from baseline (Week 1) to Week 25.|ANOVA|Model: Change = Treatment + Pooled Investigator||||||0.019
72550467|NCT00406848|144630911|SUPERIORITY_OR_OTHER|||||||0.048||95.0||||p-value is for Mean Cell Hemoglobin Concentration change from baseline (Week 1) to Week 25.|ANOVA|Model: Change=Treatment+Pooled Investigator||||||0.048
72550468|NCT00406848|144630912|SUPERIORITY_OR_OTHER|||||||0.04||95.0||||p-value is for Chloride change from baseline (Week 1) to Week 25.|ANOVA|Model: Change = Treatment + Pooled Investigator||||||0.040
72550469|NCT00406848|144630912|SUPERIORITY_OR_OTHER|||||||0.036||95.0||||p-value is for Fasting Glucose change from baseline (Week 1) to Week 25.|ANOVA|Model: Change=Treatment+Pooled Investigator||||||0.036
72550470|NCT00406848|144630913|SUPERIORITY_OR_OTHER|||||||0.019||95.0|||||Fisher Exact|||||||0.019
72550471|NCT00406848|144630914|SUPERIORITY_OR_OTHER|||||||0.815||95.0||||p-value is for QT Interval change from baseline (Week 1) to Week 25.|ANCOVA|Model: Change=Treatment+Pooled Investigator+Baseline||||||0.815
72550472|NCT00406848|144630914|SUPERIORITY_OR_OTHER|||||||0.721||95.0||||p-value is for QTcF Interval change from baseline (Week 1) to Week 25.|ANCOVA|Model: Change=Treatment+Pooled Investigator+Baseline||||||0.721
72550473|NCT00406848|144630914|SUPERIORITY_OR_OTHER|||||||0.376||95.0||||p-value is for QTcB Interval change from baseline (Week 1) to Week 25.|ANCOVA|Model: Change=Treatment+Pooled Investigator+Baseline||||||0.376
72550474|NCT00406848|144630914|SUPERIORITY_OR_OTHER|||||||0.065||95.0||||p-value is for PR Interval change from baseline (Week 1) to Week 25.|ANCOVA|Model: Change=Treatment+Pooled Investigator+Baseline||||||0.065
72550475|NCT00406848|144630914|SUPERIORITY_OR_OTHER|||||||0.11||95.0||||p-value is for QRS Interval change from baseline (Week 1) to Week 25.|ANCOVA|Model: Change=Treatment+Pooled Investigator+Baseline||||||0.110
72550476|NCT00406848|144630915|SUPERIORITY_OR_OTHER|||||||0.11||95.0||||p-value is for Successful Treatment Outcome defined with HAMD-17 ≤7 criteria.|Fisher Exact|||||||0.110
72550477|NCT00406848|144630915|SUPERIORITY_OR_OTHER|||||||0.016||95.0||||p-value is for Successful Treatment Outcome defined with HAMD-17 ≤10 criteria.|Fisher Exact|||||||0.016
72550478|NCT00406848|144630916|SUPERIORITY_OR_OTHER|||||||0.511||95.0||||p-value is for Composite Cognitive Score change from baseline (Week 1) to Week 9.|ANCOVA|Model: Change=Treatment+Pooled Investigator+Baseline||||||0.511
72550479|NCT00406848|144630916|SUPERIORITY_OR_OTHER|||||||0.3||95.0||||p-value is for Composite Cognitive Score change from baseline (Week 1) to Week 25.|ANCOVA|Model: Change=Treatment+Pooled Investigator+Baseline||||||0.300
72550480|NCT00406848|144630916|SUPERIORITY_OR_OTHER|||||||0.922||95.0||||p-value is for Learning Trials Score change from baseline (Week 1) to Week 9.|ANCOVA|Model: Change=Treatment+Pooled Investigator+Baseline||||||0.922
72550481|NCT00406848|144630916|SUPERIORITY_OR_OTHER|||||||0.19||95.0||||p-value is for Learning Trials Score change from baseline (Week 1) to Week 25.|ANCOVA|Model: Change=Treatment+Pooled Investigator+Baseline||||||0.190
72550482|NCT00406848|144630916|SUPERIORITY_OR_OTHER|||||||0.85||95.0||||p-value is for Delayed Recall Score change from baseline (Week 1) to Week 9.|ANCOVA|Model: Change=Treatment+Pooled Investigator+Baseline||||||0.850
72550483|NCT00406848|144630916|SUPERIORITY_OR_OTHER|||||||0.158||95.0||||p-value is for Delayed Recall Score change from baseline (Week 1) to Week 25.|ANCOVA|Model: Change=Treatment+Pooled Investigator+Baseline||||||0.158
72550484|NCT00406848|144630916|SUPERIORITY_OR_OTHER|||||||0.099||95.0||||p-value is for SDST Score change from baseline (Week 1) to Week 9.|ANCOVA|Model: Change=Treatment+Pooled Investigator+Baseline||||||0.099
72550485|NCT00406848|144630916|SUPERIORITY_OR_OTHER|||||||0.141||95.0||||p-value is for SDST Score change from baseline (Week 1) to Week 25.|ANCOVA|Model: Change=Treatment+Pooled Investigator+Baseline||||||0.141
72550486|NCT00406848|144630916|SUPERIORITY_OR_OTHER|||||||0.379||95.0||||p-value is for 2DCT Score change from baseline (Week 1) to Week 9.|ANCOVA|Model: Change=Treatment+Pooled Investigator+Baseline||||||0.379
72550487|NCT00406848|144630916|SUPERIORITY_OR_OTHER|||||||0.858||95.0||||p-value is for 2DCT Score change from baseline (Week 1) to Week 25.|ANCOVA|Model: Change=Treatment+Pooled Investigator+Baseline||||||0.858
72550488|NCT00406848|144630916|SUPERIORITY_OR_OTHER|||||||0.591||95.0||||p-value is for Trail Making Test Score change from baseline (Week 1) to Week 9.|ANCOVA|Model: Change=Treatment+Pooled Investigator+Baseline||||||0.591
72550489|NCT00406848|144630916|SUPERIORITY_OR_OTHER|||||||0.242||95.0||||p-value is for Trail Making Test Score change from baseline (Week 1) to Week 25.|ANCOVA|Model: Change=Treatment+Pooled Investigator+Baseline||||||0.242
72550490|NCT02719522|144630947|SUPERIORITY|The primary safety objective was to determine if the 2-sided 95% upper confidence interval of the primary safety endpoint was below the threshold of 15%|||||<|0.001|||||||Clopper-Pearson|||The primary safety objective was to determine if the 2-sided 95% upper confidence interval of the primary safety endpoint was below the threshold of 15%. Missing safety data for subjects who were lost to FU without any evidence of a major stroke/death were imputed in the analysis using multiple imputation. Subjects who withdrew from the study prior to completion and had experienced a major stroke or death were counted towards the primary safety endpoint as having experienced the event.||||<0.001
72550491|NCT01706926|144631008|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.69|STANDARD_ERROR_OF_MEAN|0.193|<|0.001|TWO_SIDED|95.0|-1.06|-0.31|||Repeated measures model|||Analysis reported for change from baseline in DAS28 (CRP) at Day 85. An estimate of the treatment difference and its 95 percent (%) confidence interval (CI) was computed by means of repeated measures model, adjusted for baseline and including terms for treatment group, visit and treatment by visit interaction. Differences \<0 favored mavrilimumab.||-0.31|-1.06|<0.001
72550492|NCT01706926|144631008|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.96|STANDARD_ERROR_OF_MEAN|0.19|<|0.001|TWO_SIDED|95.0|-1.33|-0.58|||Repeated measures model|||Analysis reported for change from baseline in DAS28 (CRP) at Day 85. An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including terms for treatment group, visit and treatment by visit interaction. Differences \<0 favored mavrilimumab.||-0.58|-1.33|<0.001
72550493|NCT01706926|144631008|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.22|STANDARD_ERROR_OF_MEAN|0.193|<|0.001|TWO_SIDED|95.0|-1.6|-0.84|||Repeated measures model|||Analysis reported for change from baseline in DAS28 (CRP) at Day 85. An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including terms for treatment group, visit and treatment by visit interaction. Differences \<0 favored mavrilimumab.||-0.84|-1.60|<0.001
72550494|NCT01706926|144631009|SUPERIORITY_OR_OTHER||Percent difference|25.9|||<|0.001|TWO_SIDED|95.0|11.5|40.3|||Regression, Logistic||95% unconditional exact CI was calculated using a test of treatment difference in proportion of responders using logistic regression with treatment as a factor. Differences greater than zero favored mavrilimumab.|||40.3|11.5|<0.001
72583274|NCT01268527|144697257|SUPERIORITY||Difference in LSM (vehicle - E6201 gel)|132.3||||0.0043|TWO_SIDED|95.0|53.9|210.7|||ANCOVA|||The following hypotheses were based on the Full Analysis Population: null Hypothesis and alternative hypothesis. P values, LSM, and CI were obtained from ANCOVA model with factors for treatment and baseline psoriatic infiltrate thickness as a continuous covariate.||210.7|53.9|0.0043
72583275|NCT01268527|144697257|SUPERIORITY||Difference in LSM (vehicle - E6201 gel)|145.0||||0.0036|TWO_SIDED|95.0|64.2|225.8|||ANCOVA|||The following hypotheses were based on the Full Analysis Population: null Hypothesis and alternative hypothesis. P values, LSM) and CI were obtained from ANCOVA model with factors for treatment and baseline psoriatic infiltrate thickness as a continuous covariate.||225.8|64.2|0.0036
72583276|NCT01268527|144697258|SUPERIORITY||Difference in LSM (vehicle - E6201 gel)|80.7||||0.0013|TWO_SIDED|95.0|34.6|126.7|||ANCOVA|||The following hypotheses were based on the Full Analysis Population: null Hypothesis and alternative hypothesis. P values, LSM, and CI were obtained from ANCOVA model with factors for treatment and baseline psoriatic infiltrate thickness as a continuous covariate.||126.7|34.6|0.0013
72550495|NCT01706926|144631009|SUPERIORITY_OR_OTHER||Percent difference|36.5|||<|0.001|TWO_SIDED|95.0|22.5|50.5|||Regression, Logistic||95% unconditional exact CI was calculated using a test of treatment difference in proportion of responders using logistic regression with treatment as a factor. Differences greater than zero favored mavrilimumab.|||50.5|22.5|<0.001
72550496|NCT01706926|144631009|SUPERIORITY_OR_OTHER||Percent difference|48.7|||<|0.001|TWO_SIDED|95.0|35.2|62.3|||Regression, Logistic||95% unconditional exact CI was calculated using a test of treatment difference in proportion of responders using logistic regression with treatment as a factor. Differences greater than zero favored mavrilimumab.|||62.3|35.2|<0.001
72550497|NCT01706926|144631016|SUPERIORITY_OR_OTHER||Percent difference|16.0||||0.013|TWO_SIDED|95.0|3.9|28.2|||Regression, Logistic||95% unconditional exact CI was calculated using a test of treatment difference in proportion of responders using logistic regression with treatment as a factor. Differences greater than zero favored mavrilimumab.|||28.2|3.9|0.013
72583277|NCT01268527|144697258|SUPERIORITY||Difference in LSM (vehicle - E6201 gel)|127.9|||<|0.0001|TWO_SIDED|95.0|92.4|163.5|||ANCOVA|||The following hypotheses were based on the Full Analysis Population: null Hypothesis and alternative hypothesis. P values, LSM, and CI were obtained from ANCOVA model with factors for treatment and baseline psoriatic infiltrate thickness as a continuous covariate.||163.5|92.4|<0.0001
72550498|NCT01706926|144631016|SUPERIORITY_OR_OTHER||Percent difference|13.5||||0.03|TWO_SIDED|95.0|1.8|25.3|||Regression, Logistic||95% unconditional exact CI was calculated using a test of treatment difference in proportion of responders using logistic regression with treatment as a factor. Differences greater than zero favored mavrilimumab.|||25.3|1.8|0.030
72550499|NCT01706926|144631016|SUPERIORITY_OR_OTHER||Percent difference|28.2|||<|0.001|TWO_SIDED|95.0|15.2|41.1|||Regression, Logistic||95% unconditional exact CI was calculated using a test of treatment difference in proportion of responders using logistic regression with treatment as a factor. Differences greater than zero favored mavrilimumab.|||41.1|15.2|<0.001
72583278|NCT01268527|144697258|SUPERIORITY||Difference in LSM (vehicle - E6201 gel)|110.2||||0.0458|TWO_SIDED|95.0|2.4|218.0|||ANCOVA|||The following hypotheses were based on the Full Analysis Population: null Hypothesis and alternative hypothesis. P values, LSM, and CI were obtained from ANCOVA model with factors for treatment and baseline psoriatic infiltrate thickness as a continuous covariate.||218.0|2.4|0.0458
72550500|NCT01706926|144631017|SUPERIORITY_OR_OTHER||Percent difference|8.6||||0.079|TWO_SIDED|95.0|0.4|16.9|||Fisher Exact||95% unconditional exact CI was calculated using the model of logit (response). p-value estimated from fisher's exact test.|||16.9|0.4|0.079
72550501|NCT01706926|144631017|SUPERIORITY_OR_OTHER||Percent difference|6.9||||0.133|TWO_SIDED|95.0|-0.8|14.6|||Fisher Exact||95% unconditional exact CI was calculated using the model of logit (response). p-value estimated from fisher's exact test.|||14.6|-0.8|0.133
72550502|NCT01706926|144631017|SUPERIORITY_OR_OTHER||Percent difference|10.2||||0.026|TWO_SIDED|95.0|1.5|18.9|||Fisher Exact||95% unconditional exact CI was calculated using the model of logit (response). p-value estimated from fisher's exact test.|||18.9|1.5|0.026
72550503|NCT01706926|144631018|SUPERIORITY_OR_OTHER||Adjusted Mean difference|15.79|STANDARD_ERROR_OF_MEAN|6.007||0.009|TWO_SIDED|95.0|3.96|27.61|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including a treatment by visit interaction term. Differences \<0 favored mavrilimumab.|||27.61|3.96|0.009
72550504|NCT01706926|144631018|SUPERIORITY_OR_OTHER||Adjusted mean difference|16.99|STANDARD_ERROR_OF_MEAN|5.879||0.004|TWO_SIDED|95.0|5.42|28.56|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including a treatment by visit interaction term. Differences \<0 favored mavrilimumab.|||28.56|5.42|0.004
72550505|NCT01706926|144631018|SUPERIORITY_OR_OTHER||Adjusted mean difference|27.47|STANDARD_ERROR_OF_MEAN|5.892|<|0.001|TWO_SIDED|95.0|15.87|39.07|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including a treatment by visit interaction term. Differences \<0 favored mavrilimumab.|||39.07|15.87|<0.001
72550506|NCT01706926|144631019|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.7|||<|0.001|TWO_SIDED|95.0|2.56|8.8|||Proportional odds analysis||Odds ratio, 95% CI and p-value were was calculated using proportional odds analysis of response model including treatment as a factor. Odds ratios greater than (\>) one favored mavrilimumab.|||8.80|2.56|<0.001
72550507|NCT01706926|144631019|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.81|||<|0.001|TWO_SIDED|95.0|2.64|8.92|||Proportional odds analysis||Odds ratio, 95% CI and p-value were was calculated using proportional odds analysis of response model including treatment as a factor. Odds ratios \>one favored mavrilimumab.|||8.92|2.64|<0.001
72550508|NCT01706926|144631019|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|7.11|||<|0.001|TWO_SIDED|95.0|3.85|13.4|||Proportional odds analysis||Odds ratio, 95% CI and p-value were was calculated using proportional odds analysis of response model including treatment as a factor. Odds ratios \>one favored mavrilimumab.|Analysis reported for change from baseline in DAS28 (CRP) at Day 85. An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including terms for treatment group, visit and treatment by visit interaction. Differences \<0 favored mavrilimumab.||13.40|3.85|<0.001
72550509|NCT01706926|144631020|SUPERIORITY_OR_OTHER||Percent difference|16.0||||0.004|TWO_SIDED|95.0|6.0|26.1|||Fisher Exact||95% unconditional exact CI was calculated using a test of treatment difference in proportion of responders using logistic regression with treatment as a factor. Differences greater than zero favored mavrilimumab.|DAS28 (CRP) remission: p-value estimated from fisher's exact test when number of placebo or active responders was less than 5.||26.1|6.0|0.004
72550510|NCT01706926|144631020|SUPERIORITY_OR_OTHER||Percent difference|12.7||||0.014|TWO_SIDED|95.0|3.3|22.1|||Fisher Exact||95% unconditional exact CI was calculated using a test of treatment difference in proportion of responders using logistic regression with treatment as a factor. Differences greater than zero favored mavrilimumab.|DAS28 (CRP) remission: p-value estimated from fisher's exact test when number of placebo or active responders was less than 5.||22.1|3.3|0.014
72550511|NCT01706926|144631020|SUPERIORITY_OR_OTHER||Percent difference|14.0||||0.007|TWO_SIDED|95.0|4.2|23.9|||Fisher Exact||95% unconditional exact CI was calculated using a test of treatment difference in proportion of responders using logistic regression with treatment as a factor. Differences greater than zero favored mavrilimumab.|DAS28 (CRP) remission: p-value estimated from fisher's exact test when number of placebo or active responders was less than 5.||23.9|4.2|0.007
72583279|NCT01268527|144697258|SUPERIORITY||Difference in LSM (vehicle - E6201 gel)|207.5|||<|0.0001|TWO_SIDED|95.0|155.2|259.9|||ANCOVA|||The following hypotheses were based on the Full Analysis Population: null Hypothesis and alternative hypothesis. P values, LSM, and CI were obtained from ANCOVA model with factors for treatment and baseline psoriatic infiltrate thickness as a continuous covariate.||259.9|155.2|<0.0001
72550512|NCT01706926|144631020|SUPERIORITY_OR_OTHER||Percent difference|24.7|||<|0.001|TWO_SIDED|95.0|12.7|36.6|||Regression, Logistic||95% unconditional exact CI was calculated using a test of treatment difference in proportion of responders using logistic regression with treatment as a factor. Differences greater than zero favored mavrilimumab.|The analysis reported DAS28 (CRP) low disease activity response.||36.6|12.7|<0.001
72550513|NCT01706926|144631020|SUPERIORITY_OR_OTHER||Percent difference|23.1|||<|0.001|TWO_SIDED|95.0|11.5|34.8|||Regression, Logistic||95% unconditional exact CI was calculated using a test of treatment difference in proportion of responders using logistic regression with treatment as a factor. Differences greater than zero favored mavrilimumab.|The analysis reported DAS28 (CRP) low disease activity response.||34.8|11.5|<0.001
72583280|NCT01268527|144697258|SUPERIORITY||Difference in LSM (vehicle - E6201 gel)|125.3||||0.0003|TWO_SIDED|95.0|71.5|179.0|||ANCOVA|||The following hypotheses were based on the Full Analysis Population: null Hypothesis and alternative hypothesis. P values, LSM, and CI were obtained from ANCOVA model with factors for treatment and baseline psoriatic infiltrate thickness as a continuous covariate.||179.0|71.5|0.0003
72583281|NCT01268527|144697258|SUPERIORITY||Difference in LSM (vehicle - E6201 gel)|128.6||||0.0029|TWO_SIDED|95.0|93.9|163.3|||ANCOVA|||The following hypotheses were based on the Full Analysis Population: null Hypothesis and alternative hypothesis. P values, LSM, and CI were obtained from ANCOVA model with factors for treatment and baseline psoriatic infiltrate thickness as a continuous covariate.||163.3|93.9|0.0029
72583282|NCT01288079|144697262|SUPERIORITY_OR_OTHER||LS mean|-1.5|STANDARD_ERROR_OF_MEAN|2.95||0.617|TWO_SIDED|95.0|-7.35|4.39|||MMRM|||Mixed model repeated measures (MMRM) includes treatment, pooled center, visit, treatment by visit interaction, region, responsiveness, and region by responsiveness as explanatory variables and the randomization MADRS total score as a covariate. Treatment, visit treatment by visit interaction, region, responsiveness, and region by responsiveness are fixed effects in the model; pooled center is a random effect.||4.39|-7.35|0.617
72583283|NCT01288079|144697262|SUPERIORITY_OR_OTHER||LS mean|-3.6|STANDARD_ERROR_OF_MEAN|3.26||0.277|TWO_SIDED|95.0|-10.06|2.91|||MMRM|||Mixed model repeated measures (MMRM) includes treatment, pooled center, visit, treatment by visit interaction, region, responsiveness, and region by responsiveness as explanatory variables and the randomization MADRS total score as a covariate. Treatment, visit, treatment by visit interaction, region, responsiveness, and region by responsiveness are fixed effects in the model; pooled center is a random effect.||2.91|-10.06|0.277
72583284|NCT01288079|144697262|SUPERIORITY_OR_OTHER||LS mean|-3.9|STANDARD_ERROR_OF_MEAN|2.95||0.194|TWO_SIDED|95.0|-9.72|2.0|||MMRM|||Mixed model repeated measures (MMRM) includes treatment, pooled center, visit, treatment by visit interaction, region, responsiveness, and region by responsiveness as explanatory variables and the randomization MADRS total score as a covariate. Treatment, visit, treatment by visit interaction, region, responsiveness, and region by responsiveness are fixed effects in the model; pooled center is a random effect.||2.00|-9.72|0.194
72583285|NCT00908544|144697270|OTHER|Changes (within CHI group) in HIV DNA in PBMC from Baseline (BL) will be tested for statistical significance using one-tailed paired t-test or Wilcoxon signed rank test as appropriate on distribution of data at months 36.|Mean Difference (Final Values)|0.2||||0.98|TWO_SIDED|95.0|0.0|0.4|||t-test, 1 sided|||||0.4|0.0|0.98
72583286|NCT00908544|144697270|OTHER|Changes (within PHI group) in HIV DNA in PBMC from Baseline (BL) will be tested for statistical significance using one-tailed paired t-test or Wilcoxon signed rank test as appropriate on distribution of data at months 36.|Mean Difference (Final Values)|-1.4|||<|0.01|TWO_SIDED|95.0|-1.7|-1.1|||t-test, 1 sided|||||-1.1|-1.7|<0.01
72583287|NCT00908544|144697270|OTHER|Changes (within CHI group) in HIV DNA in PBMC from Baseline (BL) will be tested for statistical significance using one-tailed paired t-test or Wilcoxon signed rank test as appropriate on distribution of data at months 84.|Mean Difference (Final Values)|0.12||||0.93|TWO_SIDED|95.0|-0.1|0.3|||t-test, 1 sided|||||0.3|-0.1|0.93
72583288|NCT00908544|144697270|OTHER|Changes (within PHI group) in HIV DNA in PBMC from Baseline (BL) will be tested for statistical significance using one-tailed paired t-test or Wilcoxon signed rank test as appropriate on distribution of data at months 84.|Mean Difference (Final Values)|-1.3|||<|0.01|TWO_SIDED|95.0|-1.6|-1.0|||t-test, 1 sided|||||-1.0|-1.6|<0.01
72583289|NCT00908544|144697271|OTHER|Changes (within CHI Group) in HIV DNA in CD4+T cells from Baseline (BL) will be tested for statistical significance using one-tailed paired t-test or Wilcoxon signed rank test as appropriate on distribution of data at month 36.|Mean Difference (Final Values)|0.2||||0.99|TWO_SIDED|95.0|0.0|0.4|||t-test, 1 sided|||||0.4|0.0|0.99
72583290|NCT00908544|144697271|OTHER|Changes (within PHI Group) in HIV DNA in CD4+T cells from Baseline (BL) will be tested for statistical significance using one-tailed paired t-test or Wilcoxon signed rank test as appropriate on distribution of data at month 36.|Mean Difference (Final Values)|-1.7|||<|0.01|TWO_SIDED|95.0|-2.0|-1.5|||t-test, 1 sided|||||-1.5|-2.0|<0.01
72583291|NCT00908544|144697271|OTHER|Changes (within CHI Group) in HIV DNA in CD4+T cells from Baseline (BL) will be tested for statistical significance using one-tailed paired t-test or Wilcoxon signed rank test as appropriate on distribution of data at month 84.|Mean Difference (Final Values)|0.2||||0.97|TWO_SIDED|95.0|0.0|0.3|||t-test, 1 sided|||||0.3|-0.0|0.97
72583292|NCT00908544|144697271|OTHER|Changes (within PHI Group) in HIV DNA in CD4+T cells from Baseline (BL) will be tested for statistical significance using one-tailed paired t-test or Wilcoxon signed rank test as appropriate on distribution of data at month 84.|Mean Difference (Final Values)|-1.7|||<|0.01|TWO_SIDED|95.0|-2.0|-1.4|||t-test, 1 sided|||||-1.4|-2.0|<0.01
72583293|NCT02387840|144697289|OTHER|This test was a two-sample test using non-parametric data. A predefined margin was not used because no gold standard exists. A p-value of less than 0.05 was considered statistically different||||||0.0002|||||||Wilcoxon (Mann-Whitney)|||Comparison of T1 values||||0.0002
72583294|NCT02387840|144697289|OTHER|This test was a two-sample test using non-parametric data. A predefined margin was not used because no gold standard exists. A p-value of less than 0.05 was considered statistically different||||||0.0003|||||||Wilcoxon (Mann-Whitney)|||Comparison of T2 values||||0.0003
72583295|NCT02387840|144697290|OTHER|This test was a two-sample test using non-parametric data. A predefined margin was not used because no gold standard exists. A p-value of less than 0.05 was considered statistically different||||||0.081|||||||Wilcoxon (Mann-Whitney)|||Comparison of T1 values||||0.081
72583296|NCT02387840|144697290|OTHER|This test was a two-sample test using non-parametric data. A predefined margin was not used because no gold standard exists. A p-value of less than 0.05 was considered statistically different||||||0.081|||||||Wilcoxon (Mann-Whitney)|||Comparison of T2 values||||0.081
72583297|NCT02387840|144697291|OTHER|This test was a two-sample test using non-parametric data. A predefined margin was not used because no gold standard exists. A p-value of less than 0.05 was considered statistically different||||||0.12|||||||Wilcoxon (Mann-Whitney)|||Comparison of T1 values||||0.12
72550514|NCT01706926|144631020|SUPERIORITY_OR_OTHER||Percent difference|33.1|||<|0.001|TWO_SIDED|95.0|20.7|45.6|||Regression, Logistic||95% unconditional exact CI was calculated using a test of treatment difference in proportion of responders using logistic regression with treatment as a factor. Differences greater than zero favored mavrilimumab.|The analysis reported DAS28 (CRP) low disease activity response.||45.6|20.7|<0.001
72550515|NCT01706926|144631021|SUPERIORITY_OR_OTHER||Adjusted mean difference|-5.68|STANDARD_ERROR_OF_MEAN|1.237|<|0.001|TWO_SIDED|95.0|-8.12|-3.24|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including terms for treatment group, visit and treatment by visit interaction. Differences \<0 favored mavrilimumab.|Analysis reported for change from baseline in swollen joint count at Day 169.||-3.24|-8.12|<0.001
72550516|NCT01706926|144631021|SUPERIORITY_OR_OTHER||Adjusted mean difference|-6.21|STANDARD_ERROR_OF_MEAN|1.211|<|0.001|TWO_SIDED|95.0|-8.6|-3.82|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including terms for treatment group, visit and treatment by visit interaction. Differences \<0 favored mavrilimumab.|Analysis reported for change from baseline in swollen joint count at Day 169.||-3.82|-8.60|<0.001
72550517|NCT01706926|144631021|SUPERIORITY_OR_OTHER||Adjusted mean difference|-7.0|STANDARD_ERROR_OF_MEAN|1.219|<|0.001|TWO_SIDED|95.0|-9.4|-4.59|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including terms for treatment group, visit and treatment by visit interaction. Differences \<0 favored mavrilimumab.|Analysis reported for change from baseline in swollen joint count at Day 169.||-4.59|-9.40|<0.001
72550518|NCT01706926|144631021|SUPERIORITY_OR_OTHER||Adjusted mean difference|-7.24|STANDARD_ERROR_OF_MEAN|1.922|<|0.001|TWO_SIDED|95.0|-11.02|-3.45|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including terms for treatment group, visit and treatment by visit interaction. Differences \<0 favored mavrilimumab.|Analysis reported for change from baseline in tender joint count at Day 169.||-3.45|-11.02|<0.001
72552753|NCT00377260|144636490|SUPERIORITY_OR_OTHER|||||||0.04||95.0|||||Regression, Logistic|The comparison was adjusted for site, history of recurrent acute otitis media and exposure to other children.||Null hypothesis: There is no difference between the two groups regarding the proportion of children colonized with penicillin-susceptible Streptococcus pneumoniae.||||.04
72552754|NCT00377260|144636491|SUPERIORITY_OR_OTHER|||||||0.03||95.0|||||Generalized estimating equations|The comparison was adjusted for site, history of recurrent acute otitis media and exposure to other children.||Null hypothesis: There is no difference between the two groups regarding the probability of middle ear effusion at the on-therapy visit.||||.03
72552755|NCT00377260|144636492|SUPERIORITY_OR_OTHER|||||||0.006||95.0|||||Generalized estimating equations|The comparison was adjusted for site, history of recurrent acute otitis media and exposure to other children.||Null hypothesis: There is no difference between the two groups regarding the probability of middle ear effusion at the end-of-therapy visit.||||.006
72552756|NCT00377260|144636493|SUPERIORITY_OR_OTHER|||||||0.04||95.0|||||Generalized estimating equations|The comparison was adjusted for site, history of recurrent acute otitis media and exposure to other children.||The analysis was ITT. The number of participants equals the number of children for which at least one ear has an interpretable tympanogram at the follow-up visit.||||.04
72552757|NCT00377260|144636494|SUPERIORITY_OR_OTHER|||||||0.2||95.0|||||Generalized estimating equations|The comparison was adjusted for site, history of recurrent acute otitis media and exposure to other children.||Null hypothesis: There is no difference between the two groups regarding visits to primary care provider.||||.20
72552758|NCT00377260|144636495|SUPERIORITY_OR_OTHER|||||||0.9||95.0|||||Generalized estimating equations|The comparison was adjusted for site, history of recurrent acute otitis media and exposure to other children.||Null hypothesis: There is no difference between the two groups regarding visits to emergency room||||.90
72552759|NCT00377260|144636496|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.22||||0.14||95.0|||||Regression, Cox|The comparison was adjusted for site, history of recurrent acute otitis media and exposure to other children.|The Amoxicillin-Clavulanate arm represents the numerator and the Placebo arm represents the denominator.|Null hypothesis: There is no difference between the two groups regarding the time to resolution of symptoms where resolution is defined as AOM-SOS score \<=1.||||.14
72552760|NCT00377260|144636497|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.37||||0.04||95.0|||||Regression, Cox|The comparison was adjusted for site, history of recurrent acute otitis media and exposure to other children.|The Amoxicillin-Clavulanate arm represents the numerator and the Placebo arm represents the denominator.|Null hypothesis: There is no difference between the two groups regarding the time to resolution of symptoms where resolution is defined as AOM-SOS score \<=1 on two consecutive occasions.||||.04
72552761|NCT00377260|144636498|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Generalized estimating equations|The comparison adjusted for site, history of recurrent acute otitis media and exposure to other children.||Null hypothesis: There is no difference between the two groups regarding the number of antibiotic prescriptions, exclusive of the blinded study medication.||||<.001
72552762|NCT00377260|144636499|SUPERIORITY_OR_OTHER|||||||0.93||95.0|||||Generalized estimating equations|The comparison was adjusted for site, history of recurrent acute otitis media and exposure to other children.||Null hypothesis: There is no difference between the two groups regarding the visits at which family member reported missing work, i.e. number of such visits / total number of follow-up assessment visits.||||.93
72550519|NCT01706926|144631021|SUPERIORITY_OR_OTHER||Adjusted mean difference|-8.45|STANDARD_ERROR_OF_MEAN|1.884|<|0.001|TWO_SIDED|95.0|-12.16|-4.74|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including terms for treatment group, visit and treatment by visit interaction. Differences \<0 favored mavrilimumab.|Analysis reported for change from baseline in tender joint count at Day 169.||-4.74|-12.16|<0.001
72550520|NCT01706926|144631021|SUPERIORITY_OR_OTHER||Adjusted mean difference|-10.42|STANDARD_ERROR_OF_MEAN|1.901|<|0.001|TWO_SIDED|95.0|-14.17|-6.67|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including terms for treatment group, visit and treatment by visit interaction. Differences \<0 favored mavrilimumab.|Analysis reported for change from baseline in tender joint count at Day 169.||-6.67|-14.17|<0.001
72550521|NCT01706926|144631022|SUPERIORITY_OR_OTHER||Adjusted mean difference|-7.94|STANDARD_ERROR_OF_MEAN|3.95||0.045|TWO_SIDED|95.0|-15.72|-0.17|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including terms for treatment group, visit and treatment by visit interaction. Differences \<0 favored mavrilimumab.|||-0.17|-15.72|0.045
72583298|NCT02387840|144697291|OTHER|This test was a two-sample test using non-parametric data. A predefined margin was not used because no gold standard exists. A p-value of less than 0.05 was considered statistically different||||||0.14|||||||Wilcoxon (Mann-Whitney)|||Comparison of T2 values||||0.14
72583299|NCT03170544|144697296|OTHER||Mean|1.33|STANDARD_ERROR_OF_MEAN|0.326|||TWO_SIDED|95.0|0.63|2.04|||||Mean (SE) and 95% CI were based on a linear fixed effects model containing a fixed effect for treatment (MK1092 Doses, Glargine).||The primary hypothesis would be supported if the Bayesian posterior probability of the true mean of GIRmax of MK-1092 lying within 1.5 and 4.5 mg/kg/min exceeded the prespecified threshold of 70% (in Part 3).|2.04|0.63|
72583300|NCT03170544|144697296|OTHER||Mean|2.74|STANDARD_ERROR_OF_MEAN|0.326|||TWO_SIDED|95.0|2.03|3.44|||||Mean (SE) and 95% CI were based on a linear fixed effects model containing a fixed effect for treatment (MK1092 Doses, Glargine).||The primary hypothesis would be supported if the Bayesian posterior probability of the true mean of GIRmax of MK-1092 lying within 1.5 and 4.5 mg/kg/min exceeded the prespecified threshold of 70% (in Part 3).|3.44|2.03|
72583301|NCT03888469|144697326|NON_INFERIORITY|Non-inferiority margin = 0.05|Least Squares Mean Difference|0.0|||||ONE_SIDED|95.0||0.0|||Mixed effects repeated measures model|Mixed effects repeated measures model with terms for lens, period and sequence as fixed effects and subject as a random effect.|Difference = DDT2 - Moist|||0.00||
72583302|NCT01609790|144697369|SUPERIORITY_OR_OTHER_LEGACY|||||||0.98|||||||Z-test|One-sided test, significance level 0.15||Assuming a 36% 6-month (6m) rate in the placebo arm \[from the March 2009 Food and Drug Administration (FDA) briefing\], a 55% rate in the AMG 386 arm, and an exponential distribution corresponds to median PFS of 4.1 and 7 months, respectively, with a hazard ratio of 0.59 (AMG 386 arm vs. placebo arm). A total of 114 patients (57 per arm) will yield 85% power to detect an absolute 19% difference of 6m PFS rate at a 1-sided alpha level of 0.15 based on a 2-sample proportion test.||||0.98
72583303|NCT01609790|144697370|SUPERIORITY_OR_OTHER_LEGACY|||||||0.85|||||||Chi-squared|||||||0.85
72583304|NCT01609790|144697371|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.46||||0.09|TWO_SIDED|95.0|0.95|2.27|||Log Rank|||||2.27|0.95|0.09
72583305|NCT01609790|144697372|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.51||||0.04|TWO_SIDED|95.0|1.02|2.24|||Log Rank|||||2.24|1.02|0.04
72583306|NCT01609790|144697373|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7|||||||Chi-squared|||||||0.7
72583307|NCT03504397|144697466|SUPERIORITY||Hazard Ratio (HR)|0.734||||0.0024|TWO_SIDED|95.0|0.591|0.91||"Log-rank test stratified by:~* Region (Asia vs Non-Asia)~* Number of organs with metastatic sites (0 to 2 vs ≥ 3)~* Prior gastrectomy (Yes or No)"|Log Rank|||||0.910|0.591|0.0024
72583308|NCT03504397|144697467|SUPERIORITY||Hazard Ratio (HR)|0.784||||0.0075|TWO_SIDED|95.0|0.644|0.954||"Log-rank test stratified by:~* Region (Asia vs Non-Asia)~* Number of organs with metastatic sites (0 to 2 vs ≥ 3)~* Prior gastrectomy (Yes or No)"|Log Rank|||||0.954|0.644|0.0075
72583309|NCT03504397|144697468|SUPERIORITY||Hazard Ratio (HR)|1.295||||0.028|TWO_SIDED|95.0|0.994|1.687||"Log-rank test stratified by:~* Region (Asia vs Non-Asia)~* Number of organs with metastatic sites (0 to 2 vs ≥ 3)~* Prior gastrectomy (Yes or No)"|Log Rank|||||1.687|0.994|0.0280
72583310|NCT03504397|144697469|SUPERIORITY||Hazard Ratio (HR)|0.713||||0.0508|TWO_SIDED|95.0|0.475|1.071||"Log-rank test stratified by:~* Region (Asia vs Non-Asia)~* Number of organs with metastatic sites (0 to 2 vs ≥ 3)~* Prior gastrectomy (Yes or No)"|Log Rank|||||1.071|0.475|0.0508
72583311|NCT03504397|144697470|SUPERIORITY||Hazard Ratio (HR)|1.142||||0.1685|TWO_SIDED|95.0|0.874|1.492|||Log Rank||"Log-rank test stratified by:~* Region (Asia vs Non-Asia)~* Number of organs with metastatic sites (0 to 2 vs ≥ 3)~* Prior gastrectomy (Yes or No)"|||1.492|0.874|0.1685
72583312|NCT03504397|144697471|SUPERIORITY|||||||0.4536|||||||Cochran-Mantel-Haenszel|Based on 1-sided Cochran-Mantel-Haenszel (CMH) test. Stratification factors were Region, Number of Metastatic Sites and Prior Gastrectomy.||||||0.4536
72583313|NCT03504397|144697472|SUPERIORITY||Hazard Ratio (HR)|0.789||||0.0721|TWO_SIDED|95.0|0.573|1.087|||Log Rank||"Log-rank test stratified by:~* Region (Asia vs Non-Asia)~* Number of organs with metastatic sites (0 to 2 vs ≥ 3)~* Prior gastrectomy (Yes or No)"|||1.087|0.573|0.0721
72583314|NCT01662635|144697481|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||Continuous variables were summarized as arithmetic means, medians and standard deviations; and categorical variables were reported as proportions with 95% confidence intervals. Inferential comparisons were performed using Student's t test. The x2 or Fisher's exact tests were used to assess significance among categorical variables.||||< 0.05
72583315|NCT00611923|144697527|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.57|||||||t-test, 2 sided|||paired t-test analysis comparing change from baseline PMTS score at month 1 between flutamide and placebo groups||||= 0.57
72583316|NCT00611923|144697527|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.27|||||||t-test, 2 sided|||paired t-test analysis comparing change from baseline PMTS score at month 2 between flutamide and placebo groups.||||= .27
72583317|NCT00611923|144697528|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.52|||||||t-test, 2 sided|||paired t-test comparing change in DRSP scores from baseline to Month 1 of treatment Larger positive change score indicates a greater reduction in symptoms from baseline.||||= 0.52
72583318|NCT00611923|144697528|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.2|||||||t-test, 2 sided|||paired t-test comparing change in DRSP scores from baseline to Month 2 of treatment Larger positive change score indicates a greater reduction in symptoms from baseline.||||= 0.2
72550522|NCT01706926|144631022|SUPERIORITY_OR_OTHER||Adjusted mean difference|-8.11|STANDARD_ERROR_OF_MEAN|3.876||0.037|TWO_SIDED|95.0|-15.73|-0.48|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including terms for treatment group, visit and treatment by visit interaction. Differences \<0 favored mavrilimumab.|||-0.48|-15.73|0.037
72550523|NCT01706926|144631022|SUPERIORITY_OR_OTHER||Adjusted mean difference|-11.32|STANDARD_ERROR_OF_MEAN|3.899||0.004|TWO_SIDED|95.0|-19.0|-3.65|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including terms for treatment group, visit and treatment by visit interaction. Differences \<0 favored mavrilimumab.|||-3.65|-19.00|0.004
72550524|NCT01706926|144631023|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.85|STANDARD_ERROR_OF_MEAN|4.137||0.837|TWO_SIDED|95.0|-8.99|7.29|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including terms for treatment group, visit and treatment by visit interaction. Differences \<0 favored mavrilimumab.|||7.29|-8.99|0.837
72550525|NCT01706926|144631023|SUPERIORITY_OR_OTHER||Adjusted mean difference|-2.19|STANDARD_ERROR_OF_MEAN|4.058||0.589|TWO_SIDED|95.0|-10.18|5.79|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including terms for treatment group, visit and treatment by visit interaction. Differences \<0 favored mavrilimumab.|||5.79|-10.18|0.589
72550526|NCT01706926|144631023|SUPERIORITY_OR_OTHER||Adjusted mean difference|-5.48|STANDARD_ERROR_OF_MEAN|4.083||0.18|TWO_SIDED|95.0|-13.52|2.55|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including terms for treatment group, visit and treatment by visit interaction. Differences \<0 favored mavrilimumab.|||2.55|-13.52|0.180
72583319|NCT00611923|144697529|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.8|||||||t-test, 2 sided|||||||= 0.8
72583320|NCT00611923|144697529|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.1|||||||t-test, 2 sided|||||||= 0.1
72583321|NCT00611923|144697530|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.15|||||||t-test, 2 sided|||paired t-test was performed comparing the Clinical Global Improvement score at month 1 between placebo and flutamide groups||||=.15
72583322|NCT00611923|144697530|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.05|||||||t-test, 2 sided|||t-test was performed comparing the Clinical Global Improvement score at month 2 between placebo and flutamide groups||||= .05
72583323|NCT00611923|144697531|SUPERIORITY_OR_OTHER_LEGACY|Comparison of change from baseline score to treatment month 1 between placebo and flutamide treated subjects.|||||=|0.5|||||||t-test, 2 sided|||||||=0.5
72583324|NCT00611923|144697531|SUPERIORITY_OR_OTHER_LEGACY|paired t-test analysis comparing change from baseline CGI severity score at month 2 between flutamide and placebo groups|||||<|0.04|||||||t-test, 2 sided|||||||<.04
72583325|NCT00611923|144697532|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.2|||||||t-test, 2 sided|||paired t-test was performed comparing the Patient Global Improvement score at month 1 between placebo and flutamide groups||||=0.2
72583326|NCT00611923|144697532|SUPERIORITY_OR_OTHER_LEGACY|paired t-test was performed comparing the Patient Globall Improvement score at treatment month 2 between placebo and flutamide groups|||||=|0.06|||||||t-test, 2 sided|||||||=0.06
72583327|NCT03588910|144697533|SUPERIORITY|Wilcoxon rank-sum tests||||||0.87|||||||Wilcoxon (Mann-Whitney)|||||||.87
72550527|NCT01706926|144631024|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.41|STANDARD_ERROR_OF_MEAN|0.397|<|0.001|TWO_SIDED|95.0|-2.2|-0.63|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including terms for treatment group, visit and treatment by visit interaction. Differences \<0 favored mavrilimumab.|||-0.63|-2.20|<0.001
72550528|NCT01706926|144631024|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.46|STANDARD_ERROR_OF_MEAN|0.389|<|0.001|TWO_SIDED|95.0|-2.23|-0.69|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including terms for treatment group, visit and treatment by visit interaction. Differences \<0 favored mavrilimumab.|||-0.69|-2.23|<0.001
72550529|NCT01706926|144631024|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.56|STANDARD_ERROR_OF_MEAN|0.391|<|0.001|TWO_SIDED|95.0|-2.33|-0.79|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including terms for treatment group, visit and treatment by visit interaction. Differences \<0 favored mavrilimumab.|||-0.79|-2.33|<0.001
72550530|NCT01706926|144631025|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.08|STANDARD_ERROR_OF_MEAN|0.108||0.479|TWO_SIDED|95.0|-0.29|0.14|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including terms for treatment group, visit and treatment by visit interaction. Differences \<0 favored mavrilimumab.|||0.14|-0.29|0.479
72550531|NCT01706926|144631025|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.16|STANDARD_ERROR_OF_MEAN|0.106||0.124|TWO_SIDED|95.0|-0.37|0.04|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including terms for treatment group, visit and treatment by visit interaction. Differences \<0 favored mavrilimumab.|||0.04|-0.37|0.124
72550532|NCT01706926|144631025|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.26|STANDARD_ERROR_OF_MEAN|0.107||0.017|TWO_SIDED|95.0|-0.47|-0.05|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including terms for treatment group, visit and treatment by visit interaction. Differences \<0 favored mavrilimumab.|||-0.05|-0.47|0.017
72583328|NCT03588910|144697534|SUPERIORITY|Wilcoxon rank-sum tests||||||0.36|||||||Wilcoxon (Mann-Whitney)|||||||.36
72583329|NCT03588910|144697535|SUPERIORITY|||||||0.91|||||||Wilcoxon (Mann-Whitney)|||||||.91
72583330|NCT03588910|144697536|SUPERIORITY|||||||0.29|||||||Wilcoxon (Mann-Whitney)|||||||.29
72583331|NCT03588910|144697537|SUPERIORITY|||||||0.36|||||||Chi-squared|||||||.36
72583332|NCT00838903|144697538|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.91|||||TWO_SIDED|95.0|-1.16|-0.65|||ANCOVA|||||-0.65|-1.16|
72583333|NCT00838903|144697538|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.35|||||TWO_SIDED|95.0|-0.53|-0.17|||ANCOVA|||||-0.17|-0.53|
72583334|NCT00838903|144697538|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.27|||||TWO_SIDED|95.0|-0.45|-0.09|||ANCOVA|||||-0.09|-0.45|
72583335|NCT00838903|144697538|SUPERIORITY_OR_OTHER||||||<|0.0001||||||The p-value is for superiority testing of albiglutide over placebo at 0.05 level.|t-test, 2 sided|The p-value is from a two-sided t-test to test whether the difference of least square means (albiglutide - placebo) is equal to zero||||||<0.0001
72369790|NCT01621802|144249928|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority criterion for sub cohort 1: The LL of the 2-sided 97.5% CI for the adjusted GMC ratio (Inv\_MMR\_CO group divided by pooled Com\_MMR\_CO group) was ≥ 0.67 for antibodies to measles, mumps and rubella viruses.|Adjusted GMC ratio|1.03|||||TWO_SIDED|97.5|0.97|1.09|||ANCOVA|Ancova model: adjustment for baseline concentration - pooled variance.|The GMCs were used to calculate the Adjusted GMCs, which in turn were used to calculate the Adjusted GMC ratio with 97.5% confidence interval.|Adjusted geometric mean concentration (GMC) ratio (Inv\_MMR\_CO group divided by Com\_MMR\_CO group) for antibodies to rubella virus.||1.09|0.97|
72583336|NCT00838903|144697538|NON_INFERIORITY_OR_EQUIVALENCE|To test whether the difference of least square means (albiglutide - sitagliptin) is equal to the pre-specified non-inferiority margin of 0.3%.|||||<|0.0001||||||The p-value is for non-inferiority testing of albiglutide versus sitagliptin at 0.0125 level.|t-test, 1 sided|||||||<0.0001
72583337|NCT00838903|144697538|NON_INFERIORITY_OR_EQUIVALENCE|To test whether the difference of least square means (albiglutide - glimepiride) is equal to the pre-specified non-inferiority margin of 0.3%.|||||<|0.0001||||||The p-value is for non-inferiority testing of albiglutide versus glimepiride at 0.0125 level.|t-test, 1 sided|||||||<0.0001
72583338|NCT00838903|144697538|SUPERIORITY_OR_OTHER|||||||0.0001||||||The p-value is for superiority testing of albiglutide versus sitagliptin at 0.025 level.|t-test, 2 sided|The p-value is from a two-sided t-test to test whether the difference of least square means (albiglutide - sitagliptin) is equal to zero.||||||0.0001
72583339|NCT00838903|144697538|SUPERIORITY_OR_OTHER|||||||0.0033||||||The p-value is for superiority testing of albiglutide versus glimepiride at 0.025 level.|t-test, 2 sided|The p-value is from a two-sided t-test to test whether the difference of least square means (albiglutide - glimepiride) is equal to zero.||||||0.0033
72583340|NCT03003962|144697565|OTHER|"The analysis was performed using the stratified log-rank test, adjusting for PD-L1 expression (TC 25% to 49% versus \>= 50%) and histology and smoking status (squamous vs. non-squamous + never smoker vs.~non-squamous + former/current smoker) and using the rank tests of association approach."|Hazard Ratio (HR)|0.84||||0.037|TWO_SIDED|95.0|0.706|0.989|||Stratified Log-rank test||The HR and confidence interval (CI) were calculated using a stratified Cox proportional hazards model|||0.989|0.706|0.037
72583341|NCT03003962|144697566|OTHER|"The analysis was performed using the stratified log-rank test, adjusting for PD-L1 expression (TC 25% to 49% versus \>= 50%) and histology and smoking status (squamous vs. non-squamous + never smoker vs.~non-squamous + former/current smoker) and using the rank tests of association approach."|Hazard Ratio (HR)|0.96||||0.628|TWO_SIDED|95.0|0.793|1.151|||Stratified log-rank test||The HR and CI were calculated using a stratified Cox proportional hazards model.|||1.151|0.793|0.628
72550533|NCT01706926|144631026|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|0.64||||0.017|TWO_SIDED|95.0|0.45|0.92|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model including terms for baseline as a continuous covariate and treatment as a factor was used for the analysis. Ratio \<1 favored mavrilimumab.|||0.92|0.45|0.017
72550534|NCT01706926|144631026|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|0.46|||<|0.001|TWO_SIDED|95.0|0.32|0.66|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model including terms for baseline as a continuous covariate and treatment as a factor was used for the analysis. Ratio \<1 favored mavrilimumab.|||0.66|0.32|<0.001
72550535|NCT01706926|144631026|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|0.44|||<|0.001|TWO_SIDED|95.0|0.31|0.63|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model including terms for baseline as a continuous covariate and treatment as a factor was used for the analysis. Ratio \<1 favored mavrilimumab.|||0.63|0.31|<0.001
72550536|NCT01706926|144631027|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|0.72||||0.003|TWO_SIDED|95.0|0.58|0.89|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model including terms for baseline as a continuous covariate and treatment as a factor was used for the analysis. Ratio \<1 favored mavrilimumab.|||0.89|0.58|0.003
72550537|NCT01706926|144631027|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|0.68|||<|0.001|TWO_SIDED|95.0|0.55|0.84|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model including terms for baseline as a continuous covariate and treatment as a factor was used for the analysis. Ratio \<1 favored mavrilimumab.|||0.84|0.55|<0.001
72550538|NCT01706926|144631027|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|0.61|||<|0.001|TWO_SIDED|95.0|0.49|0.75|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model including terms for baseline as a continuous covariate and treatment as a factor was used for the analysis. Ratio \<1 favored mavrilimumab.|||0.75|0.49|<0.001
72550539|NCT01706926|144631028|SUPERIORITY_OR_OTHER||Percent difference|4.9||||0.21|TWO_SIDED|95.0|-0.8|10.7|||Fisher Exact||95% unconditional exact CI was calculated using the model of logit (response) with treatment as a factor. Differences \>0 favored mavrilimumab.|||10.7|-0.8|0.210
72550540|NCT01706926|144631028|SUPERIORITY_OR_OTHER||Percent difference|1.1||||1|TWO_SIDED|95.0|-2.9|5.1|||Fisher Exact||95% unconditional exact CI was calculated using the model of logit (response) with treatment as a factor. Differences \>0 favored mavrilimumab.|||5.1|-2.9|1.000
72550541|NCT01706926|144631028|SUPERIORITY_OR_OTHER||Percent difference|3.8||||0.207|TWO_SIDED|95.0|-1.6|9.2|||Fisher Exact||95% unconditional exact CI was calculated using the model of logit (response) with treatment as a factor. Differences \>0 favored mavrilimumab.|||9.2|-1.6|0.207
72550542|NCT01706926|144631029|SUPERIORITY_OR_OTHER||Percent difference|4.9||||0.21|TWO_SIDED|95.0|-0.8|10.7|||Fisher Exact||95% unconditional exact CI was calculated using the model of logit (response) with treatment as a factor. Differences \>0 favored mavrilimumab.|||10.7|-0.8|0.210
72550543|NCT01706926|144631029|SUPERIORITY_OR_OTHER||Percent difference|2.3||||0.621|TWO_SIDED|95.0|-2.3|6.9|||Fisher Exact||95% unconditional exact CI was calculated using the model of logit (response) with treatment as a factor. Differences \>0 favored mavrilimumab.|||6.9|-2.3|0.621
72550544|NCT01706926|144631029|SUPERIORITY_OR_OTHER||Percent difference|6.4||||0.062|TWO_SIDED|95.0|0.0|12.7|||Fisher Exact||95% unconditional exact CI was calculated using the model of logit (response) with treatment as a factor. Differences \>0 favored mavrilimumab.|||12.7|0.0|0.062
72550545|NCT01706926|144631030|SUPERIORITY_OR_OTHER||Percent difference|3.7||||0.245|TWO_SIDED|95.0|-0.4|7.8|||Fisher Exact||95% unconditional exact CI was calculated using the model of logit (response) with treatment as a factor. Differences \>0 favored mavrilimumab.|||7.8|-0.4|0.245
72550546|NCT01706926|144631030|SUPERIORITY_OR_OTHER||Percent difference|1.2||||1|TWO_SIDED|95.0|-1.1|3.5|||Fisher Exact||95% unconditional exact CI was calculated using the model of logit (response) with treatment as a factor. Differences \>0 favored mavrilimumab.|||3.5|-1.1|1.000
72550547|NCT01706926|144631030|SUPERIORITY_OR_OTHER||Percent difference|1.3||||0.494|TWO_SIDED|95.0|-1.2|3.7|||Fisher Exact||95% unconditional exact CI was calculated using the model of logit (response) with treatment as a factor. Differences \>0 favored mavrilimumab.|||3.7|-1.2|0.494
72550548|NCT01706926|144631031|SUPERIORITY_OR_OTHER||Adjusted mean difference|1.18|STANDARD_ERROR_OF_MEAN|1.608||0.463|TWO_SIDED|95.0|-1.99|4.35|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including terms for treatment group, visit and treatment by visit interaction. Differences \>0 favored mavrilimumab.|||4.35|-1.99|0.463
72550549|NCT01706926|144631031|SUPERIORITY_OR_OTHER||Adjusted mean difference|2.27|STANDARD_ERROR_OF_MEAN|1.574||0.151|TWO_SIDED|95.0|-0.83|5.37|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including terms for treatment group, visit and treatment by visit interaction. Differences \>0 favored mavrilimumab.|||5.37|-0.83|0.151
72550550|NCT01706926|144631031|SUPERIORITY_OR_OTHER||Adjusted mean difference|3.92|STANDARD_ERROR_OF_MEAN|1.578||0.014|TWO_SIDED|95.0|0.81|7.02|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including terms for treatment group, visit and treatment by visit interaction. Differences \>0 favored mavrilimumab.|||7.02|0.81|0.014
72550551|NCT02848326|144631040|SUPERIORITY||Least squares mean difference|-1.15|STANDARD_ERROR_OF_MEAN|0.4||0.0039|TWO_SIDED|95.0|-1.93|-0.37||Mixed-effects model for repeated measures (MMRM) model included baseline monthly migraine days as a covariate, treatment group and visit (month) as fixed factors, and treatment group-by-visit and baseline-by-visit as interaction terms.|MMRM|||||-0.37|-1.93|0.0039
72550552|NCT02848326|144631040|SUPERIORITY||Least squares mean difference|-0.91|STANDARD_ERROR_OF_MEAN|0.33||0.0056|TWO_SIDED|95.0|-1.55|-0.27||MMRM model included baseline monthly migraine days as a covariate, treatment group and visit (month) as fixed factors, and treatment group-by-visit and baseline-by-visit as interaction terms.|MMRM|||||-0.27|-1.55|0.0056
72583342|NCT04242498|144697654|SUPERIORITY||Odds Ratio (OR)|2.422||||0.004|TWO_SIDED|97.5|1.221|4.804|||Regression, Logistic|||||4.804|1.221|0.004
72583343|NCT04242498|144697654|SUPERIORITY||Odds Ratio (OR)|2.287||||0.003|TWO_SIDED|97.5|1.22|4.291|||Regression, Logistic|||||4.291|1.220|0.003
72550553|NCT02848326|144631040|SUPERIORITY||Least squares mean difference|-0.7|STANDARD_ERROR_OF_MEAN|0.33||0.0325|TWO_SIDED|95.0|-1.35|-0.06||MMRM model included baseline monthly migraine days as a covariate, treatment group and visit (month) as fixed factors, and treatment group-by-visit and baseline-by-visit as interaction terms.|MMRM|||||-0.06|-1.35|0.0325
72550554|NCT02848326|144631040|SUPERIORITY||Least squares mean difference|-1.39|STANDARD_ERROR_OF_MEAN|0.42||0.001|TWO_SIDED|95.0|-2.21|-0.56||MMRM model included baseline monthly migraine days as a covariate, treatment group and visit (month) as fixed factors, and treatment group-by-visit and baseline-by-visit as interaction terms.|MMRM|||||-0.56|-2.21|0.0010
72550555|NCT02848326|144631040|SUPERIORITY||Least squares mean difference|-1.29|STANDARD_ERROR_OF_MEAN|0.41||0.0016|TWO_SIDED|95.0|-2.09|-0.49||MMRM model included baseline monthly migraine days as a covariate, treatment group and visit (month) as fixed factors, and treatment group-by-visit and baseline-by-visit as interaction terms.|MMRM|||||-0.49|-2.09|0.0016
72550556|NCT02848326|144631041|SUPERIORITY||Least squares mean difference|-1.38|STANDARD_ERROR_OF_MEAN|0.43||0.0014|TWO_SIDED|95.0|-2.23|-0.54||MMRM model included baseline monthly headache days as a covariate, treatment group and visit (month) as fixed factors, and treatment group-by-visit and baseline-by-visit as interaction terms.|MMRM|||||-0.54|-2.23|0.0014
72550557|NCT02848326|144631041|SUPERIORITY||Least squares mean difference|-1.24|STANDARD_ERROR_OF_MEAN|0.36||0.0005|TWO_SIDED|95.0|-1.94|-0.55||MMRM model included baseline monthly headache days as a covariate, treatment group and visit (month) as fixed factors, and treatment group-by-visit and baseline-by-visit as interaction terms.|MMRM|||||-0.55|-1.94|0.0005
72550558|NCT02848326|144631041|SUPERIORITY||Least squares mean difference|-0.94|STANDARD_ERROR_OF_MEAN|0.36||0.0087|TWO_SIDED|95.0|-1.64|-0.24||MMRM model included baseline monthly headache days as a covariate, treatment group and visit (month) as fixed factors, and treatment group-by-visit and baseline-by-visit as interaction terms.|MMRM|||||-0.24|-1.64|0.0087
72550559|NCT02848326|144631041|SUPERIORITY||Least squares mean difference|-1.3|STANDARD_ERROR_OF_MEAN|0.46||0.0044|TWO_SIDED|95.0|-2.2|-0.41||MMRM model included baseline monthly headache days as a covariate, treatment group and visit (month) as fixed factors, and treatment group-by-visit and baseline-by-visit as interaction terms.|MMRM|||||-0.41|-2.20|0.0044
72550560|NCT02848326|144631041|SUPERIORITY||Least squares mean difference|-1.39|STANDARD_ERROR_OF_MEAN|0.44||0.0017|TWO_SIDED|95.0|-2.26|-0.53||MMRM model included baseline monthly headache days as a covariate, treatment group and visit (month) as fixed factors, and treatment group-by-visit and baseline-by-visit as interaction terms.|MMRM|||||-0.53|-2.26|0.0017
72550561|NCT02848326|144631042|SUPERIORITY||Odds Ratio (OR)|1.5||||0.0617|TWO_SIDED|95.0|0.98|2.31||Generalized linear mixed model (GLMM) for repeated measures with fixed factors(treatment group,visit), covariates(baseline migraine days), interactions(treatment group;baseline migraine days by visit) with an unstructured covariance matrix.|GLMM for repeated measures|||||2.31|0.98|0.0617
72550562|NCT02848326|144631042|SUPERIORITY||Odds Ratio (OR)|1.46||||0.0369|TWO_SIDED|95.0|1.02|2.08||GLMM for repeated measures with fixed factors (treatment group, visit), covariates (baseline migraine days), interactions (treatment group by visit; baseline migraine days by visit) with an unstructured covariance matrix.|GLMM for repeated measures|||||2.08|1.02|0.0369
72550563|NCT02848326|144631042|SUPERIORITY||Odds Ratio (OR)|1.42||||0.0512|TWO_SIDED|95.0|1.0|2.03||GLMM for repeated measures with fixed factors (treatment group, visit), covariates (baseline migraine days), interactions (treatment group by visit; baseline migraine days by visit) with an unstructured covariance matrix.|GLMM for repeated measures|||||2.03|1.00|0.0512
72583344|NCT04242498|144697655|SUPERIORITY||Odds Ratio (OR)|2.722||||0.007|TWO_SIDED|97.5|1.182|6.267|||Regression, Logistic|||||6.267|1.182|0.007
72583345|NCT04242498|144697655|SUPERIORITY||Odds Ratio (OR)|3.007||||0.002|TWO_SIDED|97.5|1.374|6.581|||Regression, Logistic|||||6.581|1.374|0.002
72583346|NCT04242498|144697656|SUPERIORITY||Odds Ratio (OR)|0.798||||0.497|TWO_SIDED|97.5|0.378|1.683|||Regression, Logistic|||||1.683|0.378|0.497
72583347|NCT04242498|144697656|SUPERIORITY||Odds Ratio (OR)|1.05||||0.868|TWO_SIDED|97.5|0.541|2.041|||Regression, Logistic|||||2.041|0.541|0.868
72550564|NCT02848326|144631042|SUPERIORITY||Odds Ratio (OR)|1.83||||0.0113|TWO_SIDED|95.0|1.15|2.91||GLMM for repeated measures with fixed factors (treatment group, visit), covariates (baseline migraine days), interactions (treatment group by visit; baseline migraine days by visit) with an unstructured covariance matrix.|GLMM for repeated measures|||||2.91|1.15|0.0113
72583348|NCT04242498|144697657|SUPERIORITY||LS mean difference|-2.393|||<|0.001|TWO_SIDED|97.5|-3.92|-0.867||Nominal p-value only due to the testing hierarchy failing on the flare outcome.|ANCOVA|||||-0.867|-3.920|<0.001
72583349|NCT04242498|144697657|SUPERIORITY||LS mean difference|-2.309|||<|0.001||97.5|-3.705|-0.914||Nominal p-value only due to the testing hierarchy failing on the flare outcome.|ANCOVA|||||-0.914|-3.705|<0.001
72583350|NCT04242498|144697658|SUPERIORITY||LS mean difference|-0.898||||0.01|TWO_SIDED|97.5|-1.684|-0.113||Nominal p-value only due to the testing hierarchy failing on the flare outcome.|ANCOVA|||||-0.113|-1.684|0.010
72583351|NCT04242498|144697658|SUPERIORITY||LS mean difference|-1.265|||<|0.001|TWO_SIDED|97.5|-1.978|-0.552||Nominal p-value only due to the testing hierarchy failing on the flare outcome.|ANCOVA|||||-0.552|-1.978|<0.001
72583352|NCT04242498|144697659|SUPERIORITY||Odds Ratio (OR)|3.273||||0.028|TWO_SIDED|97.5|0.974|10.997||Nominal p-value only due to the testing hierarchy failing on the flare outcome.|Regression, Logistic|||||10.997|0.974|0.028
72583353|NCT04242498|144697659|SUPERIORITY||Odds Ratio (OR)|3.756||||0.01|TWO_SIDED|97.5|1.189|11.867||Nominal p-value only due to the testing hierarchy failing on the flare outcome.|Regression, Logistic|||||11.867|1.189|0.010
72550565|NCT02848326|144631042|SUPERIORITY||Odds Ratio (OR)|2.03||||0.0019|TWO_SIDED|95.0|1.3|3.18||GLMM for repeated measures with fixed factors (treatment group, visit), covariates (baseline migraine days), interactions (treatment group by visit; baseline migraine days by visit) with an unstructured covariance matrix.|GLMM for repeated measure|||||3.18|1.30|0.0019
72550566|NCT02848326|144631043|SUPERIORITY||Least squares mean difference|-1.3|STANDARD_ERROR_OF_MEAN|0.35||0.0002|TWO_SIDED|95.0|-1.99|-0.6||MMRM model included baseline monthly acute medication use days as a covariate, treatment group and visit (month) as fixed factors, and treatment group-by-visit and baseline-by-visit as interaction terms.|MMRM|||||-0.60|-1.99|0.0002
72550567|NCT02848326|144631043|SUPERIORITY||Least squares mean difference|-1.44|STANDARD_ERROR_OF_MEAN|0.29|<|0.0001|TWO_SIDED|95.0|-2.01|-0.87||MMRM model included baseline monthly acute medication use days as a covariate, treatment group and visit (month) as fixed factors, and treatment group-by-visit and baseline-by-visit as interaction terms.|MMRM|||||-0.87|-2.01|<0.0001
72550568|NCT02848326|144631043|SUPERIORITY||Least squares mean difference|-1.11|STANDARD_ERROR_OF_MEAN|0.29||0.0001|TWO_SIDED|95.0|-1.68|-0.54||MMRM model included baseline monthly acute medication use days as a covariate, treatment group and visit (month) as fixed factors, and treatment group-by-visit and baseline-by-visit as interaction terms.|MMRM|||||-0.54|-1.68|0.0001
72550569|NCT02848326|144631043|SUPERIORITY||Least squares mean difference|-1.35|STANDARD_ERROR_OF_MEAN|0.37||0.0003|TWO_SIDED|95.0|-2.08|-0.62||MMRM model included baseline monthly acute medication use days as a covariate, treatment group and visit (month) as fixed factors, and treatment group-by-visit and baseline-by-visit as interaction terms.|MMRM|||||-0.62|-2.08|0.0003
72550570|NCT02848326|144631043|SUPERIORITY||Least squares mean difference|-1.22|STANDARD_ERROR_OF_MEAN|0.36||0.0007|TWO_SIDED|95.0|-1.93|-0.52||MMRM model included baseline monthly acute medication use days as a covariate, treatment group and visit (month) as fixed factors, and treatment group-by-visit and baseline-by-visit as interaction terms.|MMRM|||||-0.52|-1.93|0.0007
72550571|NCT04526210|144631051|OTHER||Geometric least square (LS) mean ratio|0.98|||||TWO_SIDED|90.0|0.9415|1.0205||||||||1.0205|0.9415|
72550572|NCT04526210|144631052|OTHER||Geometric LS mean ratio|0.978|||||TWO_SIDED|90.0|0.9344|1.0244||||||||1.0244|0.9344|
72550573|NCT04526210|144631053|OTHER||Geometric LS mean ratio|0.981|||||TWO_SIDED|90.0|0.9368|1.0269||||||||1.0269|0.9368|
72550574|NCT02937701|144631061|EQUIVALENCE|Clinical equivalence for the primary endpoint was to be evaluated sequentially by first comparing the 2-sided 90% CI for RD of ACR20 at week 22 between ABP 710 and infliximab with an equivalence margin of (-15%, 15%). If the first test was successful, RD of ACR20 at week 22 was to be further evaluated by comparing the 2-sided 90% CI between ABP 710 and infliximab with an equivalence margin of (-12%, 15%).|Response Difference|9.37|||||TWO_SIDED|90.0|2.67|15.96||||||For the primary analysis of ACR20, the response difference (RD) was estimated by the Mantel-Haenszel (MH) estimate and the 90% confidence intervals (CIs) of RD were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use for RA).||15.96|2.67|
72550575|NCT02937701|144631061|EQUIVALENCE|Clinical equivalence for the primary endpoint was to be evaluated sequentially by first comparing the 2-sided 90% CI for RD of ACR20 at week 22 between ABP 710 and infliximab with an equivalence margin of (-15%, 15%). If the first test was successful, RD of ACR20 at week 22 was to be further evaluated by comparing the 2-sided 90% CI between ABP 710 and infliximab with an equivalence margin of (-12%, 15%).|Response Difference|9.3|||||TWO_SIDED|90.0|2.67|15.92|||||Response Difference is based on a generalized linear model with actual stratification variables (geographic region and prior biologic use for RA) as covariates in the model.|A sensitivity analysis with the RD estimate and CIs for RD of ACR20 estimated using a generalized linear model with geographic region and prior biologic use for RA as covariates was also conducted.||15.92|2.67|
72550576|NCT02937701|144631061|EQUIVALENCE|Clinical equivalence for the primary endpoint was to be evaluated sequentially by first comparing the 2-sided 90% CI for RD of ACR20 at week 22 between ABP 710 and infliximab with an equivalence margin of (-15%, 15%). If the first test was successful, RD of ACR20 at week 22 was to be further evaluated by comparing the 2-sided 90% CI between ABP 710 and infliximab with an equivalence margin of (-12%, 15%).|Response Difference|7.184|||||TWO_SIDED|90.0|0.748|13.62|||||The ACR core set includes tender joint count, swollen joint count, subject's global health assessment, investigator's global health assessment, subject's assessment of disease related pain, HAQ-DI, and CRP.|A post-hoc analysis was conducted to adjust for the impact of random imbalance in baseline demographic and disease characteristics between the 2 treatment groups. The MH estimate of RD and corresponding CIs were estimated using a nonparametric analysis of covariance method with stratification factors geographic region and prior biologic use, and adjustment for baseline covariates (ACR core set, age, use of oral corticosteroid, use of NSAID, body mass index categories, and methotrexate dose).||13.620|0.748|
72550577|NCT02937701|144631062|OTHER||Response Difference|8.03|||||TWO_SIDED|90.0|1.15|14.81||||||The response difference at week 2 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).||14.81|1.15|
72550578|NCT02937701|144631062|OTHER||Response Difference|4.96|||||TWO_SIDED|90.0|-1.8|11.64||||||The response difference at week 6 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).||11.64|-1.80|
72550579|NCT02937701|144631062|OTHER||Response Difference|9.37|||||TWO_SIDED|90.0|-0.51|12.87||||||The response difference at week 14 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).||12.87|-0.51|
72550580|NCT02937701|144631063|OTHER||Response Difference|3.05|||||TWO_SIDED|90.0|-5.26|11.73||||||The response difference (ABP 710/ABP 710 minus Infliximab/Infliximab) at week 30 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).||11.73|-5.26|
72369791|NCT01621802|144249928|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority criterion for sub cohort 2: The LL of the 2-sided 97.5% CI for the adjusted GMC ratio (Inv\_MMR\_I group divided by pooled Com\_MMR\_I group) was ≥ 0.67 for antibodies to measles, mumps and rubella viruses.|Adjusted GMC ratio|1.01|||||TWO_SIDED|97.5|0.95|1.07|||ANCOVA|Ancova model: adjustment for baseline concentration - pooled variance.|The GMCs were used to calculate the Adjusted GMCs, which in turn were used to calculate the Adjusted GMC ratio with 97.5% confidence interval.|||1.07|0.95|
72550581|NCT02937701|144631063|OTHER||Response Difference|8.5|||||TWO_SIDED|90.0|-1.18|17.97||||||The response difference (Infliximab/ABP 710 minus Infliximab/Infliximab) at week 30 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).||17.97|-1.18|
72550582|NCT02937701|144631063|OTHER||Response Difference|3.31|||||TWO_SIDED|90.0|-4.61|11.7||||||The response difference (ABP 710/ABP 710 minus Infliximab/Infliximab) at week 34 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).||11.70|-4.61|
72550583|NCT02937701|144631063|OTHER||Response Difference|4.06|||||TWO_SIDED|90.0|-5.4|13.4||||||The response difference (Infliximab/ABP 710 minus Infliximab/Infliximab) at week 34 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).||13.40|-5.40|
72550584|NCT02937701|144631063|OTHER||Response Difference|0.82|||||TWO_SIDED|90.0|-7.34|9.4||||||The response difference (ABP 710/ABP 710 minus Infliximab/Infliximab) at week 38 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).||9.40|-7.34|
72550585|NCT02937701|144631063|OTHER||Response Difference|2.79|||||TWO_SIDED|90.0|-6.86|12.34||||||The response difference (Infliximab/ABP 710 minus Infliximab/Infliximab) at week 38 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).||12.34|-6.86|
72583354|NCT01108718|144697663|SUPERIORITY_OR_OTHER||Rate of Preference|0.45|STANDARD_DEVIATION|0.5|>|0.1|TWO_SIDED|95.0|0.43|0.47|||McNemar||Rate of preference refers specifically to Tempur-Pedic Mattress.|h0: Rate Preference Tempur-pedic mattress = Rate Preference control mattress h1: Rate Preference Tempur-pedic mattress = Rate Preference control mattress||.47|.43|>0.1
72583355|NCT03380429|144697664|SUPERIORITY||Mean Difference (Final Values)|12.0|||<|0.001|TWO_SIDED|95.0|5.2|18.8||p-value was calculated using ANCOVA.|ANCOVA||Analysis was performed by ANCOVA adjusted for randomized treatment arm, Baseline adherence, duration of run-in (visits), country, gender and age.|||18.8|5.2|<0.001
72583356|NCT03380429|144697665|OTHER||Mean Difference (Final Values)|8.2||||0.016|TWO_SIDED|95.0|1.6|14.9||p-value was calculated using ANCOVA.|ANCOVA||Analysis was performed by ANCOVA adjusted for randomized treatment arm, Baseline adherence, duration of run-in (visits), country, gender and age.|||14.9|1.6|0.016
72550586|NCT02937701|144631063|OTHER||Response Difference|-3.74|||||TWO_SIDED|90.0|-12.27|5.17||||||The response difference (ABP 710/ABP 710 minus Infliximab/Infliximab) at week 46 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).||5.17|-12.27|
72550587|NCT02937701|144631063|OTHER||Response Difference|1.12|||||TWO_SIDED|90.0|-8.89|11.08||||||The response difference (Infliximab/ABP 710 minus Infliximab/Infliximab) at week 46 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).||11.08|-8.89|
72550588|NCT02937701|144631063|OTHER||Response Difference|-5.25|||||TWO_SIDED|90.0|-13.24|3.29||||||The response difference (ABP 710/ABP 710 minus Infliximab/Infliximab) at week 50 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).||3.29|-13.24|
72583357|NCT03380429|144697665|OTHER||Mean Difference (Final Values)|9.3||||0.006|TWO_SIDED|95.0|2.7|16.0||p-value was calculated using ANCOVA.|ANCOVA||Analysis was performed by ANCOVA adjusted for randomized treatment arm, Baseline adherence, duration of run-in (visits), country, gender and age.|||16.0|2.7|0.006
72583358|NCT03380429|144697665|OTHER||Mean Difference (Final Values)|8.1||||0.018|TWO_SIDED|95.0|1.4|14.8||p-value was calculated using ANCOVA.|ANCOVA||Analysis was performed by ANCOVA adjusted for randomized treatment arm, Baseline adherence, duration of run-in (visits), country, gender and age.|||14.8|1.4|0.018
72583359|NCT03380429|144697666|OTHER||Mean Difference (Final Values)|9.3||||0.003|TWO_SIDED|95.0|3.2|15.3||p-value was calculated using ANCOVA.|ANCOVA||Analysis was performed by ANCOVA adjusted for randomized treatment arm, Baseline adherence, duration of run-in (visits), country, gender and age.|||15.3|3.2|0.003
72583360|NCT03380429|144697666|OTHER||Mean Difference (Final Values)|7.7||||0.011|TWO_SIDED|95.0|1.8|13.7||p-value was calculated using ANCOVA.|ANCOVA||Analysis was performed by ANCOVA adjusted for randomized treatment arm, Baseline adherence, duration of run-in (visits), country, gender and age.|||13.7|1.8|0.011
72583361|NCT03380429|144697666|OTHER||Mean Difference (Final Values)|5.5||||0.066|TWO_SIDED|95.0|-0.4|11.4||p-value was calculated using ANCOVA.|ANCOVA||Analysis was performed by ANCOVA adjusted for randomized treatment arm, Baseline adherence, duration of run-in (visits), country, gender and age.|||11.4|-0.4|0.066
72583362|NCT03380429|144697666|OTHER||Mean Difference (Final Values)|2.8||||0.359|TWO_SIDED|95.0|-3.1|8.7||p-value was calculated using ANCOVA.|ANCOVA||Analysis was performed by ANCOVA adjusted for randomized treatment arm, Baseline adherence, duration of run-in (visits), country, gender and age.|||8.7|-3.1|0.359
72583363|NCT03380429|144697667|OTHER||Mean Difference (Final Values)|9.7||||0.004|TWO_SIDED|95.0|3.1|16.3||p-value was calculated using ANCOVA.|ANCOVA||Analysis was performed by ANCOVA adjusted for randomized treatment arm, Baseline adherence, duration of run-in (visits), country, gender and age.|||16.3|3.1|0.004
72583364|NCT03380429|144697667|OTHER||Mean Difference (Final Values)|7.1||||0.032|TWO_SIDED|95.0|0.6|13.5||p-value was calculated using ANCOVA.|ANCOVA||Analysis was performed by ANCOVA adjusted for randomized treatment arm, Baseline adherence, duration of run-in (visits), country, gender and age.|||13.5|0.6|0.032
72583365|NCT03380429|144697667|OTHER||Mean Difference (Final Values)|5.9||||0.07|TWO_SIDED|95.0|-0.5|12.4||p-value was calculated using ANCOVA.|ANCOVA||Analysis was performed by ANCOVA adjusted for randomized treatment arm, Baseline adherence, duration of run-in (visits), country, gender and age.|||12.4|-0.5|0.070
72550589|NCT02937701|144631063|OTHER||Response Difference|-1.49|||||TWO_SIDED|90.0|-11.01|8.04||||||The response difference (Infliximab/ABP 710 minus Infliximab/Infliximab) at week 50 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).||8.04|-11.01|
72550590|NCT02937701|144631064|OTHER||Response Difference|4.41|||||TWO_SIDED|90.0|-0.56|9.38||||||The response difference at week 2 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).||9.38|-0.56|
72550591|NCT02937701|144631064|OTHER||Response Difference|1.62|||||TWO_SIDED|90.0|-4.71|7.94||||||The response difference at week 6 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).||7.94|-4.71|
72550592|NCT02937701|144631064|OTHER||Response Difference|2.3|||||TWO_SIDED|90.0|-4.45|9.03||||||The response difference at week 14 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).||9.03|-4.45|
72550593|NCT02937701|144631064|OTHER||Response Difference|7.09|||||TWO_SIDED|90.0|0.27|13.83||||||The response difference at week 22 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).||13.83|0.27|
72550594|NCT02937701|144631065|OTHER||Response Difference|-1.33|||||TWO_SIDED|90.0|-10.4|7.62||||||The response difference (ABP 710/ABP 710 minus Infliximab/Infliximab) at week 30 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).||7.62|-10.40|
72550595|NCT02937701|144631065|OTHER||Response Difference|3.24|||||TWO_SIDED|90.0|-7.28|13.67||||||The response difference (Infliximab/ABP 710 minus Infliximab/Infliximab) at week 30 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).||13.67|-7.28|
72550596|NCT02937701|144631065|OTHER||Response Difference|6.52|||||TWO_SIDED|90.0|-2.62|15.48||||||The response difference (ABP 710/ABP 710 minus Infliximab/Infliximab) at week 34 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).||15.48|-2.62|
72550597|NCT02937701|144631065|OTHER||Response Difference|10.74|||||TWO_SIDED|90.0|0.12|21.03||||||The response difference (Infliximab/ABP 710 minus Infliximab/Infliximab) at week 34 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).||21.03|0.12|
72550598|NCT02937701|144631065|OTHER||Response Difference|0.56|||||TWO_SIDED|90.0|-8.54|9.59||||||The response difference (ABP 710/ABP 710 minus Infliximab/Infliximab) at week 38 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).||9.59|-8.54|
72550599|NCT02937701|144631065|OTHER||Response Difference|2.93|||||TWO_SIDED|90.0|-7.62|13.39||||||The response difference (Infliximab/ABP 710 minus Infliximab/Infliximab) at week 38 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).||13.39|-7.62|
72550600|NCT02937701|144631065|OTHER||Response Difference|-1.04|||||TWO_SIDED|90.0|-10.11|7.93||||||The response difference (ABP 710/ABP 710 minus Infliximab/Infliximab) at week 46 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).||7.93|-10.11|
72550601|NCT02937701|144631065|OTHER||Response Difference|6.14|||||TWO_SIDED|90.0|-4.44|16.54||||||The response difference (Infliximab/ABP 710 minus Infliximab/Infliximab) at week 46 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).||16.54|-4.44|
72550602|NCT02937701|144631065|OTHER||Response Difference|-5.43|||||TWO_SIDED|90.0|-14.39|3.71||||||The response difference (ABP 710/ABP 710 minus Infliximab/Infliximab) at week 50 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).||3.71|-14.39|
72550603|NCT02937701|144631065|OTHER||Response Difference|2.98|||||TWO_SIDED|90.0|-7.51|13.37||||||The response difference (Infliximab/ABP 710 minus Infliximab/Infliximab) at week 50 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).||13.37|-7.51|
72550604|NCT02937701|144631066|OTHER||Response Difference|-2.5|||||TWO_SIDED|90.0|-5.84|0.83||||||The response difference at week 2 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).||0.83|-5.84|
72550605|NCT02937701|144631066|OTHER||Response Difference|-2.43|||||TWO_SIDED|90.0|-7.47|2.64||||||The response difference at week 6 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).||2.64|-7.47|
72550606|NCT02937701|144631066|OTHER||Response Difference|5.46|||||TWO_SIDED|90.0|-0.01|10.91||||||The response difference at week 14 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).||10.91|-0.01|
72550607|NCT02937701|144631066|OTHER||Response Difference|4.58|||||TWO_SIDED|90.0|-1.21|10.34||||||The response difference at week 22 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).||10.34|-1.21|
72550608|NCT02937701|144631067|OTHER||Response Difference|0.2|||||TWO_SIDED|90.0|-8.12|8.02||||||The response difference (ABP 710/ABP 710 minus Infliximab/Infliximab) at week 30 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).||8.02|-8.12|
72550609|NCT02937701|144631067|OTHER||Response Difference|-0.08|||||TWO_SIDED|90.0|-9.39|9.28||||||The response difference (Infliximab/ABP 710 minus Infliximab/Infliximab) at week 30 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).||9.28|-9.39|
72550610|NCT02937701|144631067|OTHER||Response Difference|1.5|||||TWO_SIDED|90.0|-7.0|9.51||||||The response difference (ABP 710/ABP 710 minus Infliximab/Infliximab) at week 34 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).||9.51|-7.00|
72550611|NCT02937701|144631067|OTHER||Response Difference|7.49|||||TWO_SIDED|90.0|-2.39|17.22||||||The response difference (Infliximab/ABP 710 minus Infliximab/Infliximab) at week 34 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).||17.22|-2.39|
72550612|NCT02937701|144631067|OTHER||Response Difference|-0.5|||||TWO_SIDED|90.0|-9.03|7.59||||||The response difference (ABP 710/ABP 710 minus Infliximab/Infliximab) at week 38 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).||7.59|-9.03|
72550613|NCT02937701|144631067|OTHER||Response Difference|3.39|||||TWO_SIDED|90.0|-6.41|13.14||||||The response difference (Infliximab/ABP 710 minus Infliximab/Infliximab) at week 38 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).||13.14|-6.41|
72550614|NCT02937701|144631067|OTHER||Response Difference|-0.43|||||TWO_SIDED|90.0|-8.98|7.66||||||The response difference (ABP 710/ABP 710 minus Infliximab/Infliximab) at week 46 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).||7.66|-8.98|
72550615|NCT02937701|144631067|OTHER||Response Difference|7.87|||||TWO_SIDED|90.0|-2.13|17.68||||||The response difference (Infliximab/ABP 710 minus Infliximab/Infliximab) at week 46 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).||17.68|-2.13|
72550616|NCT02937701|144631067|OTHER||Response Difference|1.95|||||TWO_SIDED|90.0|-6.81|10.29||||||The response difference (ABP 710/ABP 710 minus Infliximab/Infliximab) at week 50 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).||10.29|-6.81|
72550617|NCT02937701|144631067|OTHER||Response Difference|12.06|||||TWO_SIDED|90.0|1.74|22.04||||||The response difference (Infliximab/ABP 710 minus Infliximab/Infliximab) at week 50 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).||22.04|1.74|
72550618|NCT02937701|144631068|OTHER||Mean Difference|-0.07|||||TWO_SIDED|90.0|-0.2|0.007||||||Week 2 difference between means (ABP 710 minus infliximab) and 90% CIs for difference between means were based on ANCOVA model with the DAS28-CRP change from baseline as the response and adjusted for the baseline DAS28-CRP measurement and the actual stratification factors: geographic region and prior biologic use for RA.||0.007|-0.20|
72550619|NCT02937701|144631068|OTHER||Mean Difference|0.0|||||TWO_SIDED|90.0|-0.17|0.16||||||Week 6 difference between means (ABP 710 minus infliximab) and 90% CIs for difference between means were based on ANCOVA model with the DAS28-CRP change from baseline as the response and adjusted for the baseline DAS28-CRP measurement and the actual stratification factors: geographic region and prior biologic use for RA.||0.16|-0.17|
72583366|NCT03380429|144697667|OTHER||Mean Difference (Final Values)|3.4||||0.294|TWO_SIDED|95.0|-3.0|9.9||p-value was calculated using ANCOVA.|ANCOVA||Analysis was performed by ANCOVA adjusted for randomized treatment arm, Baseline adherence, duration of run-in (visits), country, gender and age.|||9.9|-3.0|0.294
72550620|NCT02937701|144631068|OTHER||Mean Difference|-0.04|||||TWO_SIDED|90.0|-0.21|0.14||||||Week 14 difference between means (ABP 710 minus infliximab) and 90% CIs for difference between means were based on ANCOVA model with the DAS28-CRP change from baseline as the response and adjusted for the baseline DAS28-CRP measurement and the actual stratification factors: geographic region and prior biologic use for RA.||0.14|-0.21|
72550621|NCT02937701|144631068|OTHER||Mean Difference|-0.01|||||TWO_SIDED|90.0|-0.2|0.17||||||Week 22 difference between means (ABP 710 minus infliximab) and 90% CIs for difference between means were based on ANCOVA model with the DAS28-CRP change from baseline as the response and adjusted for the baseline DAS28-CRP measurement and the actual stratification factors: geographic region and prior biologic use for RA.||0.17|-0.20|
72550622|NCT02937701|144631069|OTHER||Mean Difference|0.16|||||TWO_SIDED|90.0|-0.08|0.4||||||Week 30 difference between means (ABP 710/ABP 710 minus Infliximab/Infliximab) and 90% CIs for difference between means were based on ANCOVA model with the DAS28-CRP change from baseline as the response and adjusted for the baseline DAS28-CRP measurement and the actual stratification factors: geographic region and prior biologic use for RA.||0.40|-0.08|
72550623|NCT02937701|144631069|OTHER||Mean Difference|0.0|||||TWO_SIDED|90.0|-0.27|0.28||||||Week 30 difference between means (Infliximab/ABP 710 minus Infliximab/Infliximab) and 90% CIs for difference between means were based on ANCOVA model with the DAS28-CRP change from baseline as the response and adjusted for the baseline DAS28-CRP measurement and the actual stratification factors: geographic region and prior biologic use for RA.||0.28|-0.27|
72550624|NCT02937701|144631069|OTHER||Mean Difference|0.11|||||TWO_SIDED|90.0|-0.12|0.35||||||Week 34 difference between means (ABP 710/ABP 710 minus Infliximab/Infliximab) and 90% CIs for difference between means were based on ANCOVA model with the DAS28-CRP change from baseline as the response and adjusted for the baseline DAS28-CRP measurement and the actual stratification factors: geographic region and prior biologic use for RA.||0.35|-0.12|
72412867|NCT02328326|144334042|SUPERIORITY||Mean Difference (Net)|0.32||||0.5|TWO_SIDED|95.0|-0.61|1.25|||Regression, Linear|Model was adjusted for baseline value of PAID\_CP, insulin use, randomization stratification variables: care partner not in home and PAM cutoff of 40|Net difference defined as 12 months minus baselineNet difference defined as 12 months minus baseline|The null hypothesis was that change (baseline to 12 months) in PAID\_CP is the same for CO-IMPACT (intervention) compared to PACT (control). The alternative hypothesis is that that COIMPACT will significantly increase patient participants' PAID\_CP score compared to patient participants in PACT.||1.25|-0.61|0.50
72412868|NCT03452917|144334043|SUPERIORITY||Mean Difference (Final Values)|-2.9||||0.82|ONE_SIDED|95.0|-8.0||||Chi-squared||||||-8.0|0.82
72412869|NCT03452917|144334043|SUPERIORITY||Mean Difference (Final Values)|-1.3||||0.66|ONE_SIDED|95.0|-6.5||||Chi-squared||||||-6.5|0.66
72412870|NCT03452917|144334044|SUPERIORITY||Mean Difference (Final Values)|-1.7||||0.44|TWO_SIDED|95.0|-6.0|2.6|||Chi-squared|||||2.6|-6.0|0.44
72412871|NCT03452917|144334044|SUPERIORITY||Mean Difference (Final Values)|-0.4||||0.85|TWO_SIDED|95.0|-4.9|4.0|||Chi-squared|||||4.0|-4.9|0.85
72412872|NCT03452917|144334045|SUPERIORITY||Mean Difference (Final Values)|2.2||||0.12|TWO_SIDED|95.0|-0.9|5.4|||Wilcoxon (Mann-Whitney)|||||5.4|-0.9|0.12
72412873|NCT03452917|144334045|SUPERIORITY||Mean Difference (Final Values)|0.5||||0.41|TWO_SIDED|95.0|-2.5|3.6|||Wilcoxon (Mann-Whitney)|||||3.6|-2.5|0.41
72412874|NCT03452917|144334046|SUPERIORITY||Mean Difference (Final Values)|-2.4||||0.42|TWO_SIDED|95.0|-8.3|3.5|||Chi-squared|||||3.5|-8.3|0.42
72412875|NCT03452917|144334046|SUPERIORITY||Mean Difference (Final Values)|-2.1||||0.49|TWO_SIDED|95.0|-8.0|3.9|||Chi-squared|||||3.9|-8.0|0.49
72412876|NCT03452917|144334047|SUPERIORITY||Mean Difference (Final Values)|0.4||||0.93|TWO_SIDED|95.0|-7.8|8.6|||Chi-squared|||||8.6|-7.8|0.93
72550625|NCT02937701|144631069|OTHER||Mean Difference|-0.03|||||TWO_SIDED|90.0|-0.3|0.24||||||Week 34 difference between means (Infliximab/ABP 710 minus Infliximab/Infliximab) and 90% CIs for difference between means were based on ANCOVA model with the DAS28-CRP change from baseline as the response and adjusted for the baseline DAS28-CRP measurement and the actual stratification factors: geographic region and prior biologic use for RA.||0.24|-0.30|
72583367|NCT03380429|144697668|OTHER||Mean Difference (Final Values)|4.8||||0.118|TWO_SIDED|95.0|-1.2|10.8||p-value was calculated using ANCOVA.|ANCOVA||Analysis was performed by ANCOVA adjusted for randomized treatment arm, Baseline rescue use, duration of run-in (visits), country, gender and age.|||10.8|-1.2|0.118
72412877|NCT03452917|144334047|SUPERIORITY||Mean Difference (Final Values)|5.3||||0.2|TWO_SIDED|95.0|-2.8|13.3|||Chi-squared|||||13.3|-2.8|0.20
72412878|NCT03452917|144334048|SUPERIORITY||Mean Difference (Final Values)|-2.0||||0.5|TWO_SIDED|95.0|-7.7|3.8|||Chi-squared|||||3.8|-7.7|0.50
72412879|NCT03452917|144334048|SUPERIORITY||Mean Difference (Final Values)|-2.1||||0.48|TWO_SIDED|95.0|-7.8|3.7|||Chi-squared|||||3.7|-7.8|0.48
72412880|NCT03452917|144334049|SUPERIORITY||Mean Difference (Final Values)|-1.7||||0.49|TWO_SIDED|95.0|-6.0|2.6|||Chi-squared|||||2.6|-6.0|0.49
72412881|NCT03452917|144334049|SUPERIORITY||Mean Difference (Final Values)|-0.4||||0.85|TWO_SIDED|95.0|-4.9|4.0|||Chi-squared|||||4.0|-4.9|0.85
72412882|NCT02091167|144334066|OTHER|||||||0.05|||||||ANOVA|||We powered for a medium effect size based on our previous study with effect size (partial ղ2) of 0.10384 for the main within-subject factor in the two-way ANOVA with repeated measures. With a power of 80%, and a two-sided probability of a type I error of 5%, the resulting minimum sample size was 30 participants. To account for waiving or dropouts we increased the estimated sample size to approximately 10%, resulting in 33 subjects in total (approximately 16 to 17 subjects in each group).|"Most of data (age, patterns of crack-cocaine use, 5-items OCCS) were normally distributed according to the D'Agostino \& Pearson normality test, thus they were analyzed by parametric tests. Between-group (sham- and real tDCS) comparisons were conducted by unpaired Student´s t-tests. For all other non-parametric data (gender, schooling, employment, marital state and tobacco use), Chi-square or Fisher tests were used to compare sham and real tDCS groups.~Besides the two-way ANOVA with repeated measures followed by Bonferroni-corrected t-tests, linear regression analyses were done over craving scores obtained along the 4-week treatment (five time-points measurements) for both groups. Additional comparisons between initial and final OCDS scores were done by paired t-tests for each group, and differences between final and initial scores were compared between sham-tDCS and real tDCS groups with unpaired t-test."|||0.05
72412883|NCT02091167|144334067|OTHER|||||||0.05|||||||Fisher Exact|||Two patients from each group were lost to follow-up after their discharge from the hospital.||||0.05
72412884|NCT02669329|144334082|OTHER||success proportion|85.2|||||TWO_SIDED|95.0|72.9|93.4||||||||93.4|72.9|
72412885|NCT01543256|144334084|NON_INFERIORITY|Non-Inferiority margin was 20%||||||0.008|||||||Exact non-inferiority|||||||.008
72412886|NCT01543256|144334085|SUPERIORITY|||||||0.568|||||||Fisher Exact|||||||.568
72412887|NCT01543256|144334086|SUPERIORITY||||||<|0.001|||||||Negative binomial|||||||<.001
72412888|NCT01543256|144334087|SUPERIORITY|||||||0.99|||||||Fisher Exact|||||||.99
72412889|NCT01543256|144334088|SUPERIORITY|||||||0.519|||||||Wilcoxon (Mann-Whitney)|||||||.519
72412890|NCT01543256|144334089|SUPERIORITY||||||<|0.001|||||||Negative binomial|||||||<.001
72412891|NCT02055352|144334127|NON_INFERIORITY_OR_EQUIVALENCE|A change of 5-10% from baseline values is considered to be clinically important. The estimated adjusted treatment difference for budesonide 400 μg twice a day/ indacaterol 150 μg once daily minus fixed combination of fluticasone/ salmeterol 250/ 50 μg twice daily was displayed along with the associated one-sided 97.5% confidence interval. If the lower limit of this confidence interval was to the right (i.e. above) - 10 mL, then non-inferiority could be claimed.||||||0.004|||||||Mixed effects General linear model|||||||0.004
72412892|NCT03809182|144334136|SUPERIORITY|||||||0.38|TWO_SIDED|95.0||||A p-value less than .05 was considered statistically significant.|Mixed Models Analysis|||Null hypothesis: There is no difference in plasmatic glucose levels between dexmedetomidine and 0.9% sodium-chloride groups.||||0.38
72550626|NCT02937701|144631069|OTHER||Mean Difference|0.06|||||TWO_SIDED|90.0|-0.18|0.3||||||Week 38 difference between means (ABP 710/ABP 710 minus Infliximab/Infliximab) and 90% CIs for difference between means were based on ANCOVA model with the DAS28-CRP change from baseline as the response and adjusted for the baseline DAS28-CRP measurement and the actual stratification factors: geographic region and prior biologic use for RA.||0.30|-0.18|
72412893|NCT03809182|144334137|SUPERIORITY|||||||0.02||||||A p-value less than .05 was considered statistically significant.|Mixed Models Analysis|||Null hypothesis: There is no difference in insulin levels between dexmedetomidine and 0.9% sodium-chloride groups.||||0.02
72412894|NCT02265705|144334206|SUPERIORITY||Odds Ratio (OR)|4.1||||0.001|TWO_SIDED|95.0|2.5|6.9|||Regression, Logistic|||||6.9|2.5|0.001
72412895|NCT02265705|144334207|SUPERIORITY||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.056||0.001|TWO_SIDED|95.0|-0.31|-0.09|||ANCOVA|||||-0.09|-0.31|0.001
72412896|NCT02265705|144334208|SUPERIORITY||Mean Difference (Final Values)|-1.02|STANDARD_ERROR_OF_MEAN|0.116||0.001|TWO_SIDED|95.0|-1.25|-0.79|||ANCOVA|||||-0.79|-1.25|0.001
72412897|NCT02265705|144334209|SUPERIORITY||Difference in response rate|1.4|||||TWO_SIDED|95.0|-0.5|3.3||||||||3.3|-0.5|
72412898|NCT02265705|144334210|SUPERIORITY||Median Difference (Final Values)|-12.9||||0.004|TWO_SIDED|95.0|-28.0|-2.9|||Wilcoxon (Mann-Whitney)|||||-2.9|-28.0|0.004
72412899|NCT02265705|144334211|SUPERIORITY||Mean Difference (Final Values)|-0.8|STANDARD_ERROR_OF_MEAN|0.23||0.002|TWO_SIDED|95.0|-1.2|-0.3|||ANCOVA|||||-0.3|-1.2|0.002
72412900|NCT02265705|144334212|SUPERIORITY||Mean Difference (Final Values)|-0.8|STANDARD_ERROR_OF_MEAN|0.2||0.001|TWO_SIDED|95.0|-1.2|-0.4|||ANCOVA|||||-0.4|-1.2|0.001
72412901|NCT02265705|144334213|SUPERIORITY||Mean Difference (Final Values)|-0.9|STANDARD_ERROR_OF_MEAN|0.2||0.001|TWO_SIDED|95.0|-1.3|-0.5|||ANCOVA|||||-0.5|-1.3|0.001
72412902|NCT00779246|144334214|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.1|||>|0.05|TWO_SIDED|95.0|0.5|2.9|||Regression, Logistic|||Null hypothesis was that ASC and CHG would be no different in preventing acquisition of MRSA.||2.9|0.5|>0.05
72412903|NCT01592435|144334223|SUPERIORITY_OR_OTHER|||||||0.02||||||level of significance (alpha) = 0.05 All p-values were calculated (and verified) by our statistician and are correct. They were rounded to fit four digits.|t-test, 1 sided|||||||0.02
72412904|NCT01592435|144334224|SUPERIORITY_OR_OTHER|||||||0||||||level of significance (alpha) = 0.05 All p-values were calculated (and verified) by our statistician and are correct. They were rounded to fit four digits.|t-test, 1 sided|||||||0.00
72412905|NCT02079805|144334225|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.44|||||TWO_SIDED|95.0|-0.89|1.78||||||Telmisartan 40 mg, Azilsartan 20 mg||1.78|-0.89|
72583368|NCT03380429|144697668|OTHER||Mean Difference (Final Values)|4.8||||0.105|TWO_SIDED|95.0|-1.0|10.7||p-value was calculated using ANCOVA.|ANCOVA||Analysis was performed by ANCOVA adjusted for randomized treatment arm, Baseline rescue use, duration of run-in (visits), country, gender and age.|||10.7|-1.0|0.105
72583369|NCT03380429|144697668|OTHER||Mean Difference (Final Values)|9.2||||0.002|TWO_SIDED|95.0|3.3|15.1||p-value was calculated using ANCOVA.|ANCOVA||Analysis was performed by ANCOVA adjusted for randomized treatment arm, Baseline rescue use, duration of run-in (visits), country, gender and age.|||15.1|3.3|0.002
72583370|NCT03380429|144697668|OTHER||Mean Difference (Final Values)|7.3||||0.015|TWO_SIDED|95.0|1.5|13.2||p-value was calculated using ANCOVA.|ANCOVA||Analysis was performed by ANCOVA adjusted for randomized treatment arm, Baseline rescue use, duration of run-in (visits), country, gender and age.|||13.2|1.5|0.015
72583371|NCT03380429|144697670|OTHER||Mean Difference (Net)|-0.5||||0.4|TWO_SIDED|95.0|-1.6|0.6||p-value was calculated using Mixed Model Repeated Measures (MMRM).|MMRM||Analysis was performed by MMRM adjusted for randomized treatment arm,Baseline ACT total score,randomized treatment arm-by-visit interaction,Baseline ACT total score-by-visit interaction,gender,age,country and participant fitted as a random factor.|||0.6|-1.6|0.400
72583372|NCT03380429|144697670|OTHER||Mean Difference (Net)|0.4||||0.441|TWO_SIDED|95.0|-0.7|1.5||p-value was calculated using MMRM.|MMRM||Analysis was performed by MMRM adjusted for randomized treatment arm,Baseline ACT total score,randomized treatment arm-by-visit interaction,Baseline ACT total score-by-visit interaction,gender,age,country and participant fitted as a random factor.|||1.5|-0.7|0.441
72583373|NCT03380429|144697670|OTHER||Mean Difference (Net)|0.8||||0.164|TWO_SIDED|95.0|-0.3|1.9||p-value was calculated using MMRM.|MMRM||Analysis was performed by MMRM adjusted for randomized treatment arm,Baseline ACT total score,randomized treatment arm-by-visit interaction,Baseline ACT total score-by-visit interaction,gender,age,country and participant fitted as a random factor.|||1.9|-0.3|0.164
72583374|NCT03380429|144697670|OTHER||Mean Difference (Net)|0.3||||0.661|TWO_SIDED|95.0|-0.9|1.4||p-value was calculated using MMRM.|MMRM||Analysis was performed by MMRM adjusted for randomized treatment arm,Baseline ACT total score,randomized treatment arm-by-visit interaction,Baseline ACT total score-by-visit interaction,gender,age,country and participant fitted as a random factor.|||1.4|-0.9|0.661
72583375|NCT03380429|144697671|OTHER||Odds Ratio (OR)|0.75||||0.385|TWO_SIDED|95.0|0.39|1.44||p-value was calculated using logistic regression|Regression, Logistic||Analysis was performed by logistic regression adjusted for randomized treatment arm, Baseline ACT total score, country, gender and age.|||1.44|0.39|0.385
72583376|NCT03380429|144697671|OTHER||Odds Ratio (OR)|1.24||||0.517|TWO_SIDED|95.0|0.64|2.42||p-value was calculated using logistic regression|Regression, Logistic||Analysis was performed by logistic regression adjusted for randomized treatment arm, Baseline ACT total score, country, gender and age.|||2.42|0.64|0.517
72583377|NCT03380429|144697671|OTHER||Odds Ratio (OR)|0.97||||0.921|TWO_SIDED|95.0|0.51|1.85||p-value was calculated using logistic regression|Regression, Logistic||Analysis was performed by logistic regression adjusted for randomized treatment arm, Baseline ACT total score, country, gender and age.|||1.85|0.51|0.921
72583378|NCT03380429|144697671|OTHER||Odds Ratio (OR)|0.72||||0.321|TWO_SIDED|95.0|0.38|1.38||p-value was calculated using logistic regression|Regression, Logistic||Analysis was performed by logistic regression adjusted for randomized treatment arm, Baseline ACT total score, country, gender and age.|||1.38|0.38|0.321
72583379|NCT03380429|144697672|OTHER||Odds Ratio (OR)|1.04||||0.911|TWO_SIDED|95.0|0.54|1.98||p-value was calculated using logistic regression|Regression, Logistic||Analysis was performed by logistic regression adjusted for randomized treatment arm, Baseline ACT total score, country, gender and age.|||1.98|0.54|0.911
72583380|NCT03380429|144697672|OTHER||Odds Ratio (OR)|1.33||||0.383|TWO_SIDED|95.0|0.7|2.54||p-value was calculated using logistic regression|Regression, Logistic||Analysis was performed by logistic regression adjusted for randomized treatment arm, Baseline ACT total score, country, gender and age.|||2.54|0.70|0.383
72583381|NCT03380429|144697672|OTHER||Odds Ratio (OR)|1.08||||0.814|TWO_SIDED|95.0|0.57|2.04||p-value was calculated using logistic regression|Regression, Logistic||Analysis was performed by logistic regression adjusted for randomized treatment arm, Baseline ACT total score, country, gender and age.|||2.04|0.57|0.814
72412906|NCT02347761|144334235|SUPERIORITY|A sample size of 215 subjects per treatment would give \~ 90% power to detect a treatment difference of 80 mL in the change from baseline in trough FEV1 at Week 12 between each of the 2 SUN-101 dose groups and placebo at alpha= 0.05, assuming a standard deviation of 255 mL and using a 2-sided test.|Least Squares Mea Difference (SE)|0.1036|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001|TWO_SIDED|95.0|0.0663|0.1409||The primary null hypothesis for this study is that the mean change from baseline in trough FEV1 at Week 12 for the SUN-101 50 mcg dose is equal to the mean change from baseline in trough FEV1 at Week 12 for Placebo.|MMixed Model Repeat Measurement|to control the family-wise Type I error rate,the Hochberg procedure(a tree-structured gatekeeping procedure)was used for comparisons of this endpoint|standard error of the least squares mean|The change from baseline in trough FEV1 was analyzed using a mixed model for repeated measures including terms for treatment, cardiovascular risk, background LABA use, visit, visit by treatment interaction, and baseline FEV1 as a covariate. An unstructured covariance matrix was used.||0.1409|0.0663|<0.0001
72412907|NCT02347761|144334235|SUPERIORITY|A sample size of 215 subjects per treatment would give \~ 90% power to detect a treatment difference of 80 mL in the change from baseline in trough FEV1 at Week 12 between each of the 2 SUN-101 dose groups and placebo at alpha= 0.05, assuming a standard deviation of 255 mL and using a 2-sided test.|Least Squares Mean Difference (SE)|0.0961|STANDARD_ERROR_OF_MEAN|0.01896|<|0.0001|TWO_SIDED|95.0|0.0589|0.1334||The primary null hypothesis for this study is that the mean change from baseline in trough FEV1 at Week 12 for the SUN-101 50 mcg dose is equal to the mean change from baseline in trough FEV1 at Week 12 for Placebo.|Mixed Model Repeat Measurement|to control the family-wise Type I error rate,the Hochberg procedure(a tree-structured gatekeeping procedure)was used for comparisons of the endpoint.|Standard error of the least squares mean|The change from baseline in trough FEV1 was analyzed using a mixed model for repeated measures including terms for treatment, cardiovascular risk, background LABA use, visit, visit by treatment interaction, and baseline FEV1 as a covariate. An unstructured covariance matrix was used.||0.1334|0.0589|<0.0001
72550627|NCT02937701|144631069|OTHER||Mean Difference|-0.08|||||TWO_SIDED|90.0|-0.36|0.2||||||Week 38 difference between means (Infliximab/ABP 710 minus Infliximab/Infliximab) and 90% CIs for difference between means were based on ANCOVA model with the DAS28-CRP change from baseline as the response and adjusted for the baseline DAS28-CRP measurement and the actual stratification factors: geographic region and prior biologic use for RA.||0.20|-0.36|
72550628|NCT02937701|144631069|OTHER||Mean Difference|0.11|||||TWO_SIDED|90.0|-0.14|0.37||||||Week 46 difference between means (ABP 710/ABP 710 minus Infliximab/Infliximab) and 90% CIs for difference between means were based on ANCOVA model with the DAS28-CRP change from baseline as the response and adjusted for the baseline DAS28-CRP measurement and the actual stratification factors: geographic region and prior biologic use for RA.||0.37|-0.14|
72550629|NCT02937701|144631069|OTHER||Mean Difference|-0.05|||||TWO_SIDED|90.0|-0.34|0.25||||||Week 46 difference between means (Infliximab/ABP 710 minus Infliximab/Infliximab) and 90% CIs for difference between means were based on ANCOVA model with the DAS28-CRP change from baseline as the response and adjusted for the baseline DAS28-CRP measurement and the actual stratification factors: geographic region and prior biologic use for RA.||0.25|-0.34|
72550630|NCT02937701|144631069|OTHER||Mean Difference|0.0|||||TWO_SIDED|90.0|-0.24|0.24||||||Week 50 difference between means (ABP 710/ABP 710 minus Infliximab/Infliximab) and 90% CIs for difference between means were based on ANCOVA model with the DAS28-CRP change from baseline as the response and adjusted for the baseline DAS28-CRP measurement and the actual stratification factors: geographic region and prior biologic use for RA.||0.24|-0.24|
72550631|NCT02937701|144631069|OTHER||Mean Difference|-0.2|||||TWO_SIDED|90.0|-0.47|0.08||||||Week 50 difference between means (Infliximab/ABP 710 minus Infliximab/Infliximab) and 90% CIs for difference between means were based on ANCOVA model with the DAS28-CRP change from baseline as the response and adjusted for the baseline DAS28-CRP measurement and the actual stratification factors: geographic region and prior biologic use for RA.||0.08|-0.47|
72550632|NCT03227445|144631086|SUPERIORITY||Odds Ratio (OR)|6.88|||<|0.001|TWO_SIDED|95.0|1.97|54.28|||stratified exact logistic model||Participants included in the model as fixed strata, treatment option was included in the exact statement and period included as fixed effects.||"There are three intercurrent events identified which could impact upon the estimand of interest:~* The participant could withdraw from randomised study device sequence and therefore withdraw from the study~* The participant could change their standard COPD maintenance medication device to one delivered via ELLIPTA, DISKUS or HANDIHALER; these subjects should have been withdrawn from the study according to the protocol.~* The participant could attend the visit without the device/s they were randomised to, in which case correct use cannot be assessed as described in the protocol.~Rescue Medication use and change to maintenance COPD medication which is not delivered via ELLIPTA, DISKUS or HANDIHALER are not considered intercurrent events"|54.28|1.97|<0.001
72550633|NCT03227445|144631088|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|Sensitivity Analyses (Primary Estimand: Hypothetical)||||||<0.001
72550634|NCT03227445|144631093|SUPERIORITY||Odds Ratio (OR)|8.85|||<|0.001|TWO_SIDED|95.0|3.45||The upper bound of the 95% CI could not be calculated due to the low number of events and is therefore displayed as NA.||stratified exact logistic model||Participants included in the model as fixed strata, treatment option was included in the exact statement and period included as fixed effects.||||3.45|<0.001
72583382|NCT03380429|144697672|OTHER||Odds Ratio (OR)|1.01||||0.986|TWO_SIDED|95.0|0.53|1.89||p-value was calculated using logistic regression|Regression, Logistic||Analysis was performed by logistic regression adjusted for randomized treatment arm, Baseline ACT total score, country, gender and age.|||1.89|0.53|0.986
72550635|NCT03227445|144631094|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|Sensitivity Analyses (Supplementary Estimand: Composite)||||||<0.001
72583383|NCT03380429|144697673|OTHER||Odds Ratio (OR)|0.93||||0.833|TWO_SIDED|95.0|0.48|1.81||p-value was calculated using logistic regression|Regression, Logistic||Analysis was performed by logistic regression adjusted for randomized treatment arm, Baseline ACT total score, country, gender and age.|||1.81|0.48|0.833
72583384|NCT03380429|144697673|OTHER||Odds Ratio (OR)|1.35||||0.383|TWO_SIDED|95.0|0.69|2.67||p-value was calculated using logistic regression|Regression, Logistic||Analysis was performed by logistic regression adjusted for randomized treatment arm, Baseline ACT total score, country, gender and age.|||2.67|0.69|0.383
72583385|NCT03380429|144697673|OTHER||Odds Ratio (OR)|0.85||||0.628|TWO_SIDED|95.0|0.44|1.63||p-value was calculated using logistic regression|Regression, Logistic||Analysis was performed by logistic regression adjusted for randomized treatment arm, Baseline ACT total score, country, gender and age.|||1.63|0.44|0.628
72550636|NCT03227445|144631095|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|Sensitivity Analyses (Primary Estimand: Hypothetical)||||||<0.001
72583386|NCT03380429|144697673|OTHER||Odds Ratio (OR)|0.94||||0.844|TWO_SIDED|95.0|0.49|1.8||p-value was calculated using logistic regression|Regression, Logistic||Analysis was performed by logistic regression adjusted for randomized treatment arm, Baseline ACT total score, country, gender and age.|||1.80|0.49|0.844
72583387|NCT00226499|144697719|OTHER|To demonstrate at least 60% VE, with respect to confirmed varicella disease over at least a two-year period of follow-up (beginning 42 days post dose 2) of Priorix-Tetra as compared to Priorix).|Vaccine Efficacy|94.943|||<|0.0001|TWO_SIDED|97.5|92.446|96.615|||Regression, Cox|||Vaccine Efficacy (VE) was measured by calculating the relative risk of a confirmed varicella case in a vaccine group compared to a confirmed varicella case in the control group.||96.615|92.446|<0.0001
72412908|NCT02347761|144334236|SUPERIORITY||Least Squares Mean (SE)|0.1264|STANDARD_ERROR_OF_MEAN|0.02076|<|0.0001|TWO_SIDED|95.0|0.0856|0.1672||In order to control the family-wise Type I error rate, the Hochberg procedure (a tree-structured gatekeeping procedure) was used for comparisons of the primary efficacy endpoints and the key secondary efficacy endpoints.|Least squares mean (SE)|||The change from baseline in trough FEV1 was analyzed using mixed model repeated measures including terms for treatment, cardiovascular risk, background LABA use, visit week, visit week by treatment interaction, and baseline FEV1 as a covariate. An unstructured covariance matrix was used.||0.1672|0.0856|<0.0001
72412909|NCT02347761|144334236|SUPERIORITY|In order to control the family-wise Type I error rate, the Hochberg procedure (a tree-structured gatekeeping procedure) was used for comparisons of the primary efficacy endpoints and the key secondary efficacy endpoints.|LS mean (SE)|0.1052|STANDARD_ERROR_OF_MEAN|0.0206|<|0.0001|TWO_SIDED|95.0|0.0647|0.1457|||LS mean (SE)|||The change from baseline in trough FEV1 was analyzed using mixed model repeated measures including terms for treatment, cardiovascular risk, background LABA use, visit week, visit week by treatment interaction, and baseline FEV1 as a covariate. An unstructured covariance matrix was used.||0.1457|0.0647|<0.0001
72412910|NCT00553267|144334326|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-2.76|STANDARD_ERROR_OF_MEAN|0.52|<|0.0001||95.0|-3.77|-1.75||Doses tested against A10 in a hierarchical manner to address issues of multiplicity. T80/A10 was tested first, then T40/A10.|ANCOVA|Adjusted for baseline and country effect||"Testing that the combination treatments are superior to monotherapy A10.~The number of patients in the treatment arms ensure the tests have over 90% power."||-1.75|-3.77|<0.0001
72550637|NCT03227445|144631096|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|Sensitivity Analyses (Supplementary Composite Estimand)||||||<0.001
72550638|NCT03227445|144631097|SUPERIORITY||Odds Ratio (OR)|6.06|||<|0.001|TWO_SIDED|95.0|2.08|24.55|||stratified exact logistic model||Participants included in the model as fixed strata, treatment option was included in the exact statement and period included as fixed effects.|||24.55|2.08|<0.001
72550639|NCT01880073|144631098|OTHER||Proportion|0.875|||||TWO_SIDED|95.0|0.74|1.0||||||||1.00|0.74|
72550640|NCT01880073|144631099|OTHER||Proportion|0.125|||||TWO_SIDED|95.0|0.0|0.26||||||||0.26|0.00|
72550641|NCT00755196|144631102|SUPERIORITY_OR_OTHER|||||||0.23|||||||2-sided sign test|||||||0.23
72550642|NCT01703832|144631104|SUPERIORITY_OR_OTHER|||||||0.1233||||||Threshold less than or equal to 0.05. The final analysis demonstrated reasonable doubt of the implicit normality assumption of the two sets of AUC data, thus medians presented for efficacy analysis. Need for further investigation (ex-post analyses).|ANCOVA|||The null-hypotheses of no treatment differences were tested by the two-sided t-tests from the respective ANCOVAs.||||0.1233
72412911|NCT00553267|144334326|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-2.85|STANDARD_ERROR_OF_MEAN|0.51|<|0.0001||95.0|-3.86|-1.84||Doses tested against A10 in a hierarchical manner to address issues of multiplicity. T80/A10 was tested first, then T40/A10.|ANCOVA|Adjusted for baseline and country effect||"Testing that the combination treatments are superior to monotherapy A10.~The number of patients in the treatment arms ensure the tests have over 90% power."||-1.84|-3.86|<0.0001
72550643|NCT01703832|144631105|SUPERIORITY_OR_OTHER|||||||0.5153||||||Threshold less than or equal to 0.05. The final analysis demonstrated reasonable doubt of the implicit normality assumption of the two sets of AUC data, thus medians presented for efficacy analysis. Need for further investigation (ex-post analyses).|ANCOVA|||The null-hypotheses of no treatment differences were tested by the two-sided t-tests from the respective ANCOVAs.||||0.5153
72550644|NCT00243932|144631125|SUPERIORITY_OR_OTHER_LEGACY|||||||0.14||95.0|||||futility (non-superiority)|||Null hypothesis: 2,700mg CoQ10 is at least 20% superior to placebo.||||0.14
72550645|NCT00437658|144631140|NON_INFERIORITY|Statistical non-inferiority was defined when the lower bound of the 95% 2-sided confidence interval for the difference between an elagolix dose and DMPA-SC in the response rate was no less than -20% at week 24 for both dysmenorrhea and non-menstrual pelvic pain.|Difference in response rates|-0.3||||0.963|TWO_SIDED|95.0|-13.4|12.7|||Pearson chi-squared||Difference in response rate = elogolix - DMPA-SC|||12.7|-13.4|0.9630
72550646|NCT00437658|144631140|NON_INFERIORITY|Statistical non-inferiority was defined when the lower bound of the 95% 2-sided confidence interval for the difference between an elagolix dose and DMPA-SC in the response rate was no less than -20% at week 24 for both dysmenorrhea and non-menstrual pelvic pain.|Difference in response rates|-12.4||||0.101|TWO_SIDED|95.0|-26.7|1.8|||Pearson chi-squared||Difference in response rate = elogolix - DMPA-SC|||1.8|-26.7|0.1010
72550647|NCT00437658|144631141|NON_INFERIORITY|Statistical non-inferiority was defined when the lower bound of the 95% 2-sided confidence interval for the difference between an elagolix dose and DMPA-SC in the response rate was no less than -20% at week 24 for both dysmenorrhea and non-menstrual pelvic pain.|Difference in response rates|9.5||||0.2048|TWO_SIDED|95.0|-5.2|24.2|||Pearson chi-squared||Difference in response rates = elagolix - DMPA-SC|||24.2|-5.2|0.2048
72550648|NCT00437658|144631141|NON_INFERIORITY|Statistical non-inferiority was defined when the lower bound of the 95% 2-sided confidence interval for the difference between an elagolix dose and DMPA-SC in the response rate was no less than -20% at week 24 for both dysmenorrhea and non-menstrual pelvic pain.|Difference in response rates|0.5||||0.9544|TWO_SIDED|95.0|-15.1|16.0|||Pearson chi-squared||Difference in response rates = elagolix - DMPA-SC|||16.0|-15.1|0.9544
72550649|NCT00437658|144631144|OTHER||Least squares mean|-5.5|||<|0.0001|TWO_SIDED|95.0|-6.2|-4.8||P-value for test of null hypothesis that the treatment group least squares mean is equal to zero.|t-test, 2 sided|||Within-group analysis of change from baseline in total CPSSS at week 24. Change from baseline was analyzed using a mixed-effects repeated measures (MERM) analysis of covariance model which included fixed effects for treatment, time, treatment-by-time interaction, a random effect for patient, and terms for baseline value and the baseline-by-time interaction.||-4.8|-6.2|< 0.0001
72550650|NCT00437658|144631144|OTHER||Least squares mean|-5.2|||<|0.0001|TWO_SIDED|95.0|-5.8|-4.5||P-value for test of null hypothesis that the treatment group least squares mean is equal to zero.|t-test, 2 sided|||Within-group analysis of change from baseline in total CPSSS at week 24. Change from baseline was analyzed using a mixed-effects repeated measures (MERM) analysis of covariance model which included fixed effects for treatment, time, treatment-by-time interaction, a random effect for patient, and terms for baseline value and the baseline-by-time interaction.||-4.5|-5.8|< 0.0001
72550651|NCT00437658|144631144|OTHER||Least squares mean|-5.3|||<|0.0001|TWO_SIDED|95.0|-6.0|-4.6||P-value for test of null hypothesis that the treatment group least squares mean is equal to zero.|t-test, 2 sided|||"Within-group analysis of change from baseline in total CPSSS at week 24.~Change from baseline was analyzed using a mixed-effects repeated measures (MERM) analysis of covariance model which included fixed effects for treatment, time, treatment-by-time interaction, a random effect for patient, and terms for baseline value and the baseline-by-time interaction."||-4.6|-6.0|< 0.0001
72550652|NCT00437658|144631145|OTHER||Least squares mean|-4.6|||<|0.0001|TWO_SIDED|95.0|-5.1|-4.0||P-value for test of null hypothesis that the treatment group least squares mean is equal to zero.|t-test, 2 sided|||"Within-group analysis of change from baseline in total CPSSS excluding dyspareunia at week 24.~Change from baseline was analyzed using a mixed-effects repeated measures (MERM) analysis of covariance model which included fixed effects for treatment, time, treatment-by-time interaction, a random effect for patient, and terms for baseline value and the baseline-by-time interaction."||-4.0|-5.1|<0.0001
72550653|NCT00437658|144631145|OTHER||Least squares mean|-4.4|||<|0.0001|TWO_SIDED|95.0|-5.0|-3.9||P-value for test of null hypothesis that the treatment group least squares mean is equal to zero.|t-test, 2 sided|||"Within-group analysis of change from baseline in total CPSSS excluding dyspareunia at week 24.~Change from baseline was analyzed using a mixed-effects repeated measures (MERM) analysis of covariance model which included fixed effects for treatment, time, treatment-by-time interaction, a random effect for patient, and terms for baseline value and the baseline-by-time interaction."||-3.9|-5.0|<0.0001
72550654|NCT00437658|144631145|OTHER||Least squares mean|-4.5|||<|0.0001|TWO_SIDED|95.0|-5.1|-3.9||P-value for test of null hypothesis that the treatment group least squares mean is equal to zero.|t-test, 2 sided|||"Within-group analysis of change from baseline in total CPSSS excluding dyspareunia at week 24.~Change from baseline was analyzed using a mixed-effects repeated measures (MERM) analysis of covariance model which included fixed effects for treatment, time, treatment-by-time interaction, a random effect for patient, and terms for baseline value and the baseline-by-time interaction."||-3.9|-5.1|< 0.0001
72550655|NCT00437658|144631146|OTHER||Least squares mean|-1.5|||<|0.0001|TWO_SIDED|95.0|-1.7|-1.2||P-value for test of null hypothesis that the treatment group least squares mean is equal to zero.|t-test, 2 sided|||Within-group analysis of change from baseline in dysmenorrhea at week 24. Change from baseline was analyzed using a mixed-effects repeated measures (MERM) analysis of covariance model which included fixed effects for treatment, time, treatment-by-time interaction, a random effect for patient, and terms for baseline value and the baseline-by-time interaction.||-1.2|-1.7|< 0.0001
72412912|NCT00553267|144334327|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-3.66|STANDARD_ERROR_OF_MEAN|0.76|<|0.0001||95.0|-5.15|-2.16|||ANCOVA|Adjusted for baseline and country effect||||-2.16|-5.15|<0.0001
72412913|NCT00553267|144334327|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-3.85|STANDARD_ERROR_OF_MEAN|0.76|<|0.0001||95.0|-5.35|-2.36|||ANCOVA|Adjusted for baseline and country effect||||-2.36|-5.35|<0.0001
72412914|NCT00553267|144334328|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.67||||0.002|TWO_SIDED|95.0|1.21|2.32|||Mantel Haenszel|Mantel-Haenszel statistics adjusted for country effect||||2.32|1.21|0.002
72583388|NCT00226499|144697719|OTHER|To demonstrate at least 60% VE, with respect to confirmed varicella disease over at least a two-year period of follow-up (beginning 42 days post dose 2) of Varilrix as compared to Priorix).|Vaccine Efficacy|65.428||||0.1265|TWO_SIDED|97.5|57.182|72.086|||Regression, Cox|||Vaccine Efficacy (VE) was measured by calculating the relative risk of a confirmed varicella case in a vaccine group compared to a confirmed varicella case in the control group.||72.086|57.182|0.1265
72583389|NCT00226499|144697720|OTHER|To demonstrate at least 60% VE, with respect to confirmed varicella disease over at least a two-year period of follow-up (beginning 42 days post dose 2) of Priorix-Tetra as compared to Priorix).|Vaccine Efficacy|99.498||||0.0001|TWO_SIDED|95.0|97.522|99.898|||Regression, Cox|||VE was measured by calculating the relative risk of a moderate or severe confirmed varicella case in a vaccine group compared to a moderate or severe confirmed varicella case in the control group.||99.898|97.522|0.0001
72583390|NCT00226499|144697720|OTHER|To demonstrate at least 60% VE, with respect to confirmed varicella disease over at least a two-year period of follow-up (beginning 42 days post dose 2) of Varilrix as compared to Priorix).|Vaccine Efficacy|90.741||||0.1265|TWO_SIDED|95.0|85.866|93.934|||Regression, Cox|||VE was measured by calculating the relative risk of a moderate or severe confirmed varicella case in a vaccine group compared to a moderate or severe confirmed varicella case in the control group.||93.934|85.866|0.1265
72583391|NCT00226499|144697721|OTHER|To demonstrate at least 60% VE, with respect to confirmed varicella disease over at least a two-year period of follow-up (beginning 42 days post dose 2) of Priorix-Tetra as compared to Priorix).|Vaccine Efficacy|92.487|||<|0.0001|TWO_SIDED|95.0|89.927|94.396|||Regression, Cox|||VE was measured by calculating the relative risk of a probable or confirmed varicella case in a vaccine group compared to a probable or confirmed varicella case in the control group.||94.396|89.927|<0.0001
72583392|NCT00226499|144697721|OTHER|To demonstrate at least 60% VE, with respect to confirmed varicella disease over at least a two-year period of follow-up (beginning 42 days post dose 2) of Varilrix as compared to Priorix).|Vaccine Efficacy|64.585||||0.1265|TWO_SIDED|95.0|57.503|70.486|||Regression, Cox|||VE was measured by calculating the relative risk of a probable or confirmed varicella case in a vaccine group compared to a probable or confirmed varicella case in the control group.||70.486|57.503|0.1265
72583393|NCT00226499|144697741|OTHER|To demonstrate at least 60% VE, with respect to confirmed varicella disease over at least a two-year period of follow-up (beginning 42 days post dose 2) of Priorix-Tetra as compared to Priorix).|Vaccine Efficacy|95.855|||<|0.0001|TWO_SIDED|95.0|94.075|97.101|||Regression, Cox|||VE was measured by calculating the relative risk of a confirmed varicella case in a vaccine group compared to a confirmed varicella case in the control group.||97.101|94.075|<0.0001
72583394|NCT00226499|144697741|OTHER|To demonstrate at least 60% VE, with respect to confirmed varicella disease over at least a two-year period of follow-up (beginning 42 days post dose 2) of Varilrix as compared to Priorix).|Vaccine Efficacy|69.812||||0.1265|TWO_SIDED|95.0|62.848|75.47|||Regression, Cox|||VE was measured by calculating the relative risk of a confirmed varicella case in a vaccine group compared to a confirmed varicella case in the control group.||75.470|62.848|0.1265
72583395|NCT00226499|144697742|OTHER|To demonstrate at least 60% VE, with respect to confirmed varicella disease over at least a two-year period of follow-up (beginning 42 days post dose 2) of Priorix-Tetra as compared to Priorix).|Vaccine Efficacy|99.072|||<|0.0001|TWO_SIDED|95.0|97.907|99.589|||Regression, Cox|||VE was measured by calculating the relative risk of a moderate or severe confirmed varicella case in a vaccine group compared to a moderate or severe confirmed varicella case in the control group.||99.589|97.907|<0.0001
72583396|NCT00226499|144697742|OTHER|To demonstrate at least 60% VE, with respect to confirmed varicella disease over at least a two-year period of follow-up (beginning 42 days post dose 2) of Varilrix as compared to Priorix).|Vaccine Efficacy|89.532||||0.1265|TWO_SIDED|95.0|86.126|92.102|||Regression, Cox|||VE was measured by calculating the relative risk of a moderate or severe confirmed varicella case in a vaccine group compared to a moderate or severe confirmed varicella case in the control group.||92.102|86.126|0.1265
72583397|NCT00226499|144697743|OTHER|To demonstrate at least 60% VE, with respect to confirmed varicella disease over at least a two-year period of follow-up (beginning 42 days post dose 2) of Priorix-Tetra as compared to Priorix).|Vaccine Efficacy|94.816|||<|0.0001|TWO_SIDED|95.0|92.838|96.248|||Regression, Cox|||VE was measured by calculating the relative risk of a probable or confirmed varicella case in a vaccine group compared to a probable or confirmed varicella case in the control group.||96.248|92.838|<0.0001
72583398|NCT00226499|144697743|OTHER|To demonstrate at least 60% VE, with respect to confirmed varicella disease over at least a two-year period of follow-up (beginning 42 days post dose 2) of Varilrix as compared to Priorix).|Vaccine Efficacy|68.932||||0.1265|TWO_SIDED|95.0|61.893|74.671|||Regression, Cox|||VE was measured by calculating the relative risk of a probable or confirmed varicella case in a vaccine group compared to a probable or confirmed varicella case in the control group.||74.671|61.893|0.1265
72412915|NCT00553267|144334328|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.91|||<|0.001||95.0|1.37|2.65|||Mantel Haenszel|Mantel-Haenszel statistics adjusted for country effect||||2.65|1.37|<0.001
72412916|NCT00553267|144334329|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.35||||0.004||95.0|1.3|4.25|||Mantel Haenszel|Mantel-Haenszel statistics adjusted for country effect||||4.25|1.30|0.004
72412917|NCT00553267|144334329|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.33||||0.004||95.0|1.29|4.22|||Mantel Haenszel|Mantel-Haenszel statistics adjusted for country effect||||4.22|1.29|0.004
72412918|NCT00553267|144334330|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.68||||0.002||95.0|1.21|2.34|||Mantel Haenszel|Mantel-Haenszel statistics adjusted for country effect||||2.34|1.21|0.002
72412919|NCT00553267|144334330|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.92|||<|0.001||95.0|1.38|2.68|||Mantel Haenszel|Mantel-Haenszel statistics adjusted for country effect||||2.68|1.38|<0.001
72550656|NCT00437658|144631146|OTHER||Least squares mean|-1.4|||<|0.0001|TWO_SIDED|95.0|-1.6|-1.2||P-value for test of null hypothesis that the treatment group least squares mean is equal to zero.|t-test, 2 sided|||Within-group analysis of change from baseline in dysmenorrhea at week 24. Change from baseline was analyzed using a mixed-effects repeated measures (MERM) analysis of covariance model which included fixed effects for treatment, time, treatment-by-time interaction, a random effect for patient, and terms for baseline value and the baseline-by-time interaction.||-1.2|-1.6|< 0.0001
72550657|NCT00437658|144631146|OTHER||Least squares mean|-1.7|||<|0.0001|TWO_SIDED|95.0|-1.9|-1.4||P-value for test of null hypothesis that the treatment group least squares mean is equal to zero.|t-test, 2 sided|||Within-group analysis of change from baseline in dysmenorrhea at week 24. Change from baseline was analyzed using a mixed-effects repeated measures (MERM) analysis of covariance model which included fixed effects for treatment, time, treatment-by-time interaction, a random effect for patient, and terms for baseline value and the baseline-by-time interaction.||-1.4|-1.9|< 0.0001
72583399|NCT00946920|144697757|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority limit for the difference between treatments (degarelix versus goserelin acetate) was chosen to be -5 percentage points.|Kaplan-Meier estimate|79.6|||||TWO_SIDED|95.0|75.6|83.7||||||The cumulative probability of testosterone ≤0.5 ng/mL from Day 3 to Day 364 was estimated by the Kaplan-Meier method. Only testosterone measurements taken at scheduled trial visits from Day 3 to Day 364 were included in the analysis. The hypothesis to test was the following: a non-inferiority assessment determined whether degarelix was non-inferior to goserelin with respect to the cumulative probability of testosterone ≤0.5 ng/mL from Day 3 to Day 364.||83.7|75.6|
72583400|NCT01597973|144697767|SUPERIORITY|||||||0.21|||||||Chi-squared|||||||0.21
72583401|NCT01597973|144697768|SUPERIORITY|||||||0.583|||||||Chi-squared|||||||0.5830
72583402|NCT01597973|144697769|SUPERIORITY|||||||0.07|||||||Chi-squared|||||||0.07
72583403|NCT01597973|144697770|SUPERIORITY|||||||0.255|||||||Chi-squared|||||||0.255
72583404|NCT01597973|144697771|SUPERIORITY|||||||0.59|||||||Chi-squared|||nephrotoxicity analysis||||0.59
72583405|NCT01597973|144697771|SUPERIORITY|||||||0.22|||||||Fisher Exact|||Hypersensitivity analysis||||0.22
72583406|NCT01597973|144697771|SUPERIORITY|||||||0.94|||||||Chi-squared|||Hepatoxicity analysis||||0.94
72583407|NCT01597973|144697771|SUPERIORITY|||||||1|||||||Fisher Exact|||Seizures analysis||||1.00
72583408|NCT01597973|144697771|SUPERIORITY|||||||0.2|||||||Fisher Exact|||Neurotoxicity analysis||||0.20
72583409|NCT03477006|144697779|SUPERIORITY|||||||0.91|||||||Chi-squared|||||||0.91
72583410|NCT03477006|144697780|SUPERIORITY|||||||0.23|||||||Chi-squared|||||||0.23
72412920|NCT00553267|144334331|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.44||||0.027||95.0|1.04|2.0|||Mantel Haenszel|Mantel-Haenszel statistics adjusted for country effect||||2.00|1.04|0.027
72412921|NCT00553267|144334331|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.55||||0.008||95.0|1.12|2.15|||Mantel Haenszel|Mantel-Haenszel statistics adjusted for country effect||||2.15|1.12|0.008
72412922|NCT00553267|144334332|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.58||||0.006||95.0|1.14|2.21|||Mantel Haenszel|Mantel-Haenszel statistics adjusted for country effect||||2.21|1.14|0.006
72550658|NCT00437658|144631147|OTHER||Least squares mean|-1.2|||<|0.0001|TWO_SIDED|95.0|-1.4|-0.9||P-value for test of null hypothesis that the treatment group least squares mean is equal to zero.|t-test, 2 sided|||Within-group analysis of change from baseline in dyspareunia at week 24. Change from baseline was analyzed using a mixed-effects repeated measures (MERM) analysis of covariance model which included fixed effects for treatment, time, treatment-by-time interaction, a random effect for patient, and terms for baseline value and the baseline-by-time interaction.||-0.9|-1.4|< 0.0001
72550659|NCT00437658|144631147|OTHER||Least squares mean|-1.0|||<|0.0001|TWO_SIDED|2.0|-1.2|-0.7||P-value for test of null hypothesis that the treatment group least squares mean is equal to zero.|t-test, 2 sided|||Within-group analysis of change from baseline in dyspareunia at week 24. Change from baseline was analyzed using a mixed-effects repeated measures (MERM) analysis of covariance model which included fixed effects for treatment, time, treatment-by-time interaction, a random effect for patient, and terms for baseline value and the baseline-by-time interaction.||-0.7|-1.2|< 0.0001
72550660|NCT00437658|144631147|OTHER||Least squares mean|-0.8|||<|0.0001|TWO_SIDED|95.0|-1.1|-0.5||P-value for test of null hypothesis that the treatment group least squares mean is equal to zero.|t-test, 2 sided|||Within-group analysis of change from baseline in dyspareunia at week 24. Change from baseline was analyzed using a mixed-effects repeated measures (MERM) analysis of covariance model which included fixed effects for treatment, time, treatment-by-time interaction, a random effect for patient, and terms for baseline value and the baseline-by-time interaction.||-0.5|-1.1|< 0.0001
72550661|NCT00437658|144631148|OTHER||Least squares mean|-1.2|||<|0.0001|TWO_SIDED|95.0|-1.4|-1.0||P-value for test of null hypothesis that the treatment group least squares mean is equal to zero.|t-test, 2 sided|||"Within-group analysis of change from baseline in non-menstrual pelvic pain at week 24.~Change from baseline was analyzed using a mixed-effects repeated measures (MERM) analysis of covariance model which included fixed effects for treatment, time, treatment-by-time interaction, a random effect for patient, and terms for baseline value and the baseline-by-time interaction."||-1.0|-1.4|< 0.0001
72550662|NCT00437658|144631148|OTHER||Least squares mean|-1.2|||<|0.0001|TWO_SIDED|95.0|-1.4|-1.0||P-value for test of null hypothesis that the treatment group least squares mean is equal to zero.|t-test, 2 sided|||"Within-group analysis of change from baseline in non-menstrual pelvic pain at week 24.~Change from baseline was analyzed using a mixed-effects repeated measures (MERM) analysis of covariance model which included fixed effects for treatment, time, treatment-by-time interaction, a random effect for patient, and terms for baseline value and the baseline-by-time interaction."||-1.0|-1.4|< 0.0001
72550663|NCT00437658|144631148|OTHER||Least squares mean|-1.1|||<|0.0001|TWO_SIDED|95.0|-1.3|-0.8||P-value for test of null hypothesis that the treatment group least squares mean is equal to zero.|t-test, 2 sided|||"Within-group analysis of change from baseline in non-menstrual pelvic pain at week 24.~Change from baseline was analyzed using a mixed-effects repeated measures (MERM) analysis of covariance model which included fixed effects for treatment, time, treatment-by-time interaction, a random effect for patient, and terms for baseline value and the baseline-by-time interaction."||-0.8|-1.3|< 0.0001
72412923|NCT00553267|144334332|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.67||||0.002||95.0|1.2|2.32|||Mantel Haenszel|Mantel-Haenszel statistics adjusted for country effect||||2.32|1.20|0.002
72412924|NCT00553267|144334333|SUPERIORITY_OR_OTHER|||||||0.006||95.0|||||Wilcoxon rank sum test|Stratified (for country) Wilcoxon rank sum test||||||0.006
72412925|NCT00553267|144334333|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon rank sum test|Stratified (for country) Wilcoxon rank sum test||||||<0.001
72421534|NCT01181726|144354217|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|95.21|||||TWO_SIDED|90.0|91.21|99.39|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||99.39|91.21|
72583411|NCT03477006|144697781|SUPERIORITY|||||||0.76|||||||Chi-squared|||||||0.76
72583412|NCT02174627|144697782|SUPERIORITY|Superiority of roxadustat compared with placebo would be declared if the lower bound of the 2-sided 95% confidence interval (CI) of the difference between roxadustat and placebo exceeded 0 g/dL.|LS Mean Difference|1.35|STANDARD_ERROR_OF_MEAN|0.041|<|0.001|TWO_SIDED|95.0|1.27|1.43|||ANCOVA|||Difference between groups (roxadustat minus placebo) in LS mean changes; MAR-based multiple imputation ANCOVA model.||1.43|1.27|<0.001
72583413|NCT02174627|144697783|SUPERIORITY||Relative Risk|9.12|||<|0.001|TWO_SIDED|95.0|7.63|10.89|||Cochran-Mantel-Haenszel|||Comparison of the percentage of responders for roxadustat versus placebo was analysed using a Cochran-Mantel-Haenszel test adjusting for baseline Hb, baseline eGFR, geographic region and CV history.||10.89|7.63|<0.001
72369792|NCT04857320|144249949|SUPERIORITY|||||||1.6e-05|||||||ANOVA|Degrees of Freedom = 5||Glucose was monitored by means of a wearable Continuous Glucose Monitor for several days prior to, during and post dosing. Measurements were gathered for each subject and averaged within-subject data. Our null hypothesis was that post prandial serum glucose would not vary significantly from their baseline values.||||0.000016
72550664|NCT00437658|144631149|OTHER||Least squares mean|-1.0|||<|0.0001|TWO_SIDED|95.0|-1.2|-0.8||P-value for test of null hypothesis that the treatment group least squares mean is equal to zero.|t-test, 2 sided|||Within-group analysis of change from baseline in pelvic tenderness at week 24. Change from baseline was analyzed using a mixed-effects repeated measures (MERM) analysis of covariance model which included fixed effects for treatment, time, treatment-by-time interaction, a random effect for patient, and terms for baseline value and the baseline-by-time interaction.||-0.8|-1.2|< 0.0001
72550665|NCT00437658|144631149|OTHER||Least squares mean|-1.0|||<|0.0001|TWO_SIDED|95.0|-1.1|-0.8||P-value for test of null hypothesis that the treatment group least squares mean is equal to zero.|t-test, 2 sided|||Within-group analysis of change from baseline in pelvic tenderness at week 24. Change from baseline was analyzed using a mixed-effects repeated measures (MERM) analysis of covariance model which included fixed effects for treatment, time, treatment-by-time interaction, a random effect for patient, and terms for baseline value and the baseline-by-time interaction.||-0.8|-1.1|< 0.0001
72550666|NCT00437658|144631149|OTHER||Least squares mean|-0.9|||<|0.0001|TWO_SIDED|95.0|-1.1|-0.7||P-value for test of null hypothesis that the treatment group least squares mean is equal to zero.|t-test, 2 sided|||Within-group analysis of change from baseline in pelvic tenderness at week 24. Change from baseline was analyzed using a mixed-effects repeated measures (MERM) analysis of covariance model which included fixed effects for treatment, time, treatment-by-time interaction, a random effect for patient, and terms for baseline value and the baseline-by-time interaction.||-0.7|-1.1|< 0.0001
72550667|NCT00437658|144631150|OTHER||Least squares mean|-0.9|||<|0.0001|TWO_SIDED|95.0|-1.0|-0.7||P-value for test of null hypothesis that the treatment group least squares mean is equal to zero.|t-test, 2 sided|||Within-group analysis of change from baseline in pelvic induration at week 24. Change from baseline was analyzed using a mixed-effects repeated measures (MERM) analysis of covariance model which included fixed effects for treatment, time, treatment-by-time interaction, a random effect for patient, and terms for baseline value and the baseline-by-time interaction.||-0.7|-1.0|< 0.0001
72550668|NCT00437658|144631150|OTHER||Least squares mean|-0.9|||<|0.0001|TWO_SIDED|95.0|-1.1|-0.7||P-value for test of null hypothesis that the treatment group least squares mean is equal to zero.|t-test, 2 sided|||Within-group analysis of change from baseline in pelvic induration at week 24. Change from baseline was analyzed using a mixed-effects repeated measures (MERM) analysis of covariance model which included fixed effects for treatment, time, treatment-by-time interaction, a random effect for patient, and terms for baseline value and the baseline-by-time interaction.||-0.7|-1.1|< 0.0001
72550669|NCT00437658|144631150|OTHER||Least squares mean|-0.8|||<|0.0001|TWO_SIDED|95.0|-0.9|-0.6|||t-test, 2 sided|||Within-group analysis of change from baseline in pelvic induration at week 24. Change from baseline was analyzed using a mixed-effects repeated measures (MERM) analysis of covariance model which included fixed effects for treatment, time, treatment-by-time interaction, a random effect for patient, and terms for baseline value and the baseline-by-time interaction.||-0.6|-0.9|<0.0001
72583414|NCT02174627|144697784|SUPERIORITY|Superiority of roxadustat compared with placebo would be declared if the lower bound of the 2-sided 95% CI of the difference between roxadustat and placebo exceeded 0 g/dL.|LS Mean Difference|1.13|STANDARD_ERROR_OF_MEAN|0.112|<|0.001|TWO_SIDED|95.0|0.91|1.35|||ANCOVA|||Difference between groups (roxadustat minus placebo) in LS mean changes; MAR-based multiple imputation ANCOVA model.||1.35|0.91|<0.001
72583415|NCT02174627|144697785|SUPERIORITY|Superiority of roxadustat compared with placebo would be declared if the lower bound of the 2-sided 95% CI of the difference between roxadustat and placebo exceeded 0.|LS Mean Difference|0.5|STANDARD_ERROR_OF_MEAN|0.013|<|0.001|TWO_SIDED|95.0|0.47|0.52|||ANCOVA|||Difference between groups (roxadustat minus placebo) in LS mean changes; ANCOVA model.||0.52|0.47|<0.001
72583416|NCT02174627|144697786|SUPERIORITY|Superiority of roxadustat compared with placebo would be declared if the lower bound of the 2-sided 95% CI of the difference between roxadustat and placebo exceeded 0.|LS Mean Difference|0.42|STANDARD_ERROR_OF_MEAN|0.013|<|0.001|TWO_SIDED|95.0|0.4|0.45|||ANCOVA|||Difference between groups (roxadustat minus placebo) in LS mean changes; ANCOVA model.||0.45|0.40|<0.001
72583417|NCT02174627|144697787|SUPERIORITY|Superiority of roxadustat compared with placebo would be declared if the lower bound of the 2-sided 95% CI of the difference between roxadustat and placebo exceeded 0.|LS Mean Difference|-0.36|STANDARD_ERROR_OF_MEAN|0.033|<|0.001|TWO_SIDED|95.0|-0.42|-0.29|||ANCOVA|||Difference between groups (roxadustat minus placebo) in LS mean changes; ANCOVA model.||-0.29|-0.42|<0.001
72583418|NCT02174627|144697788|SUPERIORITY|Superiority of roxadustat compared with placebo would be declared if the upper limit of the 2-sided 95% CI for the HR was ≤1.0.|Hazard Ratio (HR)|0.26|||<|0.001|TWO_SIDED|95.0|0.23|0.31|||Regression, Cox|||Treatments were compared using a Cox proportional hazards model, with baseline Hb and baseline eGFR as continuous variables used as covariates, and treatment group, CV history and geographic region as fixed effects. The Efron method was used for ties and p-values were calculated using the Wald test.||0.31|0.23|<0.001
72583419|NCT02174627|144697789|SUPERIORITY|Superiority of roxadustat compared with placebo would be declared if the upper limit of the 2-sided 95% CI for the HR was ≤1.0.|Hazard Ratio (HR)|0.37|||<|0.001|TWO_SIDED|95.0|0.3|0.44|||Regression, Cox|||Treatments were compared using a Cox proportional hazards model, with baseline Hb and baseline eGFR as continuous variables used as covariates, and treatment group, CV history and geographic region as fixed effects. The Efron method was used for ties and p-values were calculated using the Wald test.||0.44|0.30|<0.001
72583420|NCT02174627|144697790|SUPERIORITY|Superiority of roxadustat compared with placebo would be declared if the lower bound of the 2-sided 95% CI of the difference between roxadustat and placebo exceeded 0.|LS Mean Difference|0.44|STANDARD_ERROR_OF_MEAN|0.283||0.12|TWO_SIDED|95.0|-0.11|0.99|||Mixed Models Analysis|||Difference between groups (roxadustat minus placebo) in LS mean changes; MMRM analysis.||0.99|-0.11|0.120
72583421|NCT02174627|144697791|OTHER||Rate of Change Difference|-0.51|STANDARD_ERROR_OF_MEAN|0.254||0.046|TWO_SIDED|95.0|-1.0|-0.01||Nominal p-value (as prior sequential outcome measure p-value did not meet \< 0.05.|Random Effects Analysis|||Difference between groups (roxadustat minus placebo) in rate of change in eGFR; random effects analysis.||-0.01|-1.00|0.046
72583422|NCT02174627|144697792|SUPERIORITY|Superiority of roxadustat compared with placebo would be declared if the lower bound of the 2-sided 95% CI of the difference between roxadustat and placebo exceeded 0.|LS Mean Difference|0.52|STANDARD_ERROR_OF_MEAN|0.269||0.051|TWO_SIDED|95.0|0.0|1.05||Nominal p-value (as prior sequential outcome measure p-value did not meet \< 0.05.|Mixed Models Analysis|||Difference between groups (roxadustat minus placebo) in LS mean changes; MMRM analysis.||1.05|0.00|0.051
72583423|NCT00071110|144697826|SUPERIORITY_OR_OTHER|||||||0.32||95.0||||Statistic (t): -1.00|t-test, 2 sided|||||||0.32
72583424|NCT00071110|144697827|SUPERIORITY_OR_OTHER|||||||0.09||95.0||||Statistic (t): 1.56|t-test, 2 sided|||||||0.09
72583425|NCT00071110|144697828|SUPERIORITY_OR_OTHER|||||||0.17||95.0||||Statistic (t): 1.40|t-test, 2 sided|||||||0.17
72583426|NCT02259010|144697864|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Ratio|0.98|||||TWO_SIDED|90.0|0.82|1.19|||||Estimates were obtained using a mixed effects model of log (PK parameter) with fixed terms for the itraconazole effect and random terms for participant within period.|||1.19|0.82|
72583427|NCT02259010|144697865|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Ratio|1.35|||||TWO_SIDED|90.0|1.02|1.79|||||Estimates were obtained using a mixed effects model of log (PK parameter) with fixed terms for the itraconazole effect and random terms for participant within period.|||1.79|1.02|
72583428|NCT02259010|144697866|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Ratio|1.39|||||TWO_SIDED|90.0|0.99|1.95|||||Estimates were obtained using a mixed effects model of log (PK parameter) with fixed terms for the itraconazole effect and random terms for participant within period.|||1.95|0.99|
72583429|NCT03578367|144697886|OTHER|No test performed|Risk Difference (RD)|19.5|||||TWO_SIDED|90.0|5.0|33.1||||||||33.1|5.0|
72583430|NCT03578367|144697886|OTHER|No test performed|Risk Difference (RD)|28.57|||||TWO_SIDED|90.0|12.4|44.8||||||||44.8|12.4|
72583431|NCT03578367|144697887|OTHER|No test performed|Risk Difference (RD)|14.29|||||TWO_SIDED|90.0|-1.7|30.3||||||||30.3|-1.7|
72583432|NCT03578367|144697887|OTHER|No test performed|Risk Difference (RD)|23.81|||||TWO_SIDED|90.0|5.9|41.7||||||||41.7|5.9|
72583433|NCT02729025|144697905|SUPERIORITY||LS Mean Treatment Difference|-3.0|STANDARD_ERROR_OF_MEAN|2.24||0.18|TWO_SIDED|95.0|-7.4|1.39|||Multivariate regression model||Treatment difference used placebo as the reference|A multivariate regression was modelled on the primary endpoint as well as three other response variables (percent change in Lp\[a\] at Weeks 8 and 16, baseline MDS TBR, and baseline Lp\[a\]). The primary endpoint was regressed on the treatment group and statin stratification factor; baseline MDS TBR and Lp(a) were regressed on the statin stratification factor, and percent changes in Lp(a) were regressed on the treatment group, statin stratification factor, visit, and treatment group by visit.||1.39|-7.40|0.18
72583434|NCT02729025|144697906|SUPERIORITY||LS Mean Treatment Difference|-13.89|STANDARD_ERROR_OF_MEAN|2.73|<|0.0001|TWO_SIDED|95.0|-19.29|-8.49|||Repeated measures linear effects model|The model included treatment group, statin stratification, scheduled visit, and the interaction of treatment with scheduled visit.|Treatment difference used placebo as the reference|||-8.49|-19.29|<0.0001
72583435|NCT02729025|144697907|SUPERIORITY||LS Mean Treatment Difference|-60.66|STANDARD_ERROR_OF_MEAN|2.6|<|0.0001|TWO_SIDED|95.0|-65.81|-55.51|||Repeated measures linear effects model|The model included treatment group, statin stratification, scheduled visit, and the interaction of treatment with scheduled visit.|Treatment difference used placebo as the reference|||-55.51|-65.81|<0.0001
72583436|NCT02729025|144697908|SUPERIORITY||LS Mean Treatment Difference|-51.29|STANDARD_ERROR_OF_MEAN|2.15|<|0.0001|TWO_SIDED|95.0|-55.85|-47.33|||Repeated measures linear effects model|The model included treatment group, statin stratification, scheduled visit, and the interaction of treatment with scheduled visit.|Treatment difference used placebo as the reference|||-47.33|-55.85|<0.0001
72583437|NCT01267019|144697909|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Mixed Models Analysis|||This is a statistical analysis to determine the training effect of social cognitive skills training (in vivo and social cog versus control).||||< .05
72583438|NCT01267019|144697910|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Mixed Models Analysis|||||||<.05
72583439|NCT01267019|144697911|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Mixed Models Analysis|||||||<.05
72583440|NCT04242446|144697919|SUPERIORITY||Odds Ratio (OR)|2.0||||0.03|TWO_SIDED|97.5|0.979|4.089|||Regression, Logistic|||||4.089|0.979|0.030
72583441|NCT04242446|144697919|SUPERIORITY||Odds Ratio (OR)|2.234||||0.006|TWO_SIDED|97.5|1.159|4.307|||Regression, Logistic|||||4.307|1.159|0.006
72583442|NCT04242446|144697920|SUPERIORITY||Odds Ratio (OR)|1.416||||0.35|TWO_SIDED|97.5|0.615|3.26||Nominal p-value only due to the testing hierarchy failing on the HISCR50 outcome.|Regression, Logistic|||||3.260|0.615|0.350
72583443|NCT04242446|144697920|SUPERIORITY||Odds Ratio (OR)|2.175||||0.021|TWO_SIDED|97.5|1.021|4.635|||Regression, Logistic|||||4.635|1.021|0.021
72583444|NCT04242446|144697921|SUPERIORITY||LS mean difference|-2.574||||0.002|TWO_SIDED|97.5|-4.472|-0.675||Nominal p-value only due to the testing hierarchy failing on the HISCR50 outcome.|ANCOVA|||||-0.675|-4.472|0.002
72583445|NCT04242446|144697921|SUPERIORITY||LS mean difference|-2.682|||<|0.001|TWO_SIDED|97.5|-4.394|-0.97|||ANCOVA|||||-0.970|-4.394|<0.001
72583446|NCT04242446|144697922|SUPERIORITY||LS mean difference|-0.551||||0.201|TWO_SIDED|97.5|-1.521|0.418||Nominal p-value only due to the testing hierarchy failing on the HISCR50 outcome.|ANCOVA|||||0.418|-1.521|0.201
72583447|NCT04242446|144697922|SUPERIORITY||LS mean difference|-1.186||||0.002|TWO_SIDED|97.5|-2.05|-0.322|||ANCOVA|||||-0.322|-2.050|0.002
72583448|NCT04242446|144697923|SUPERIORITY||Odds Ratio (OR)|1.618||||0.367|TWO_SIDED|97.5|0.489|5.352||Nominal p-value only due to the testing hierarchy failing on the HISCR50 outcome.|Regression, Logistic|||||5.352|0.489|0.367
72583449|NCT04242446|144697923|SUPERIORITY||Odds Ratio (OR)|2.757||||0.041|TWO_SIDED|97.5|0.909|8.364|||Regression, Logistic|||||8.364|0.909|0.041
72583450|NCT00803790|144697943|SUPERIORITY_OR_OTHER_LEGACY||least square mean ratio|1.01|||||TWO_SIDED|90.0|0.92|1.11||||||||1.11|0.92|
72583451|NCT00803790|144697944|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Ratio|0.94|||||TWO_SIDED|90.0|0.89|1.0||||||Least squares mean ratio for AUC 0-80 hr for vitamin D following administration of combination tablet and vitamin D alone. No correction for endogenous Vitamin D concentration pre-treatment was made in the analysis.||1.00|0.89|
72583452|NCT00803790|144697945|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Ratio|0.94|||||TWO_SIDED|90.0|0.88|1.0||||||"Least squares mean ratio for Cmax for vitamin D following administration of combination tablet and vitamin D alone.~No correction for endogenous Vitamin D concentration pre-treatment was made in the analysis."||1.00|0.88|
72550670|NCT00437658|144631151|OTHER||Least squares mean|-32.3|||<|0.0001|TWO_SIDED|95.0|-39.2|-25.4||P-value for test of null hypothesis that the treatment group least squares mean is equal to zero.|t-test, 2 sided|||Within-group analysis of change from baseline in peak VAS for pelvic pain at week 24. Change from baseline was analyzed using a mixed-effects repeated measures (MERM) analysis of covariance model which included fixed effects for treatment, time, treatment-by-time interaction, a random effect for patient, and terms for baseline value and the baseline-by-time interaction.||-25.4|-39.2|< 0.0001
72550671|NCT00437658|144631151|OTHER||Least squares mean|-32.9|||<|0.0001|TWO_SIDED|95.0|-39.4|-26.4||P-value for test of null hypothesis that the treatment group least squares mean is equal to zero.|t-test, 2 sided|||Within-group analysis of change from baseline in peak VAS for pelvic pain at week 24. Change from baseline was analyzed using a mixed-effects repeated measures (MERM) analysis of covariance model which included fixed effects for treatment, time, treatment-by-time interaction, a random effect for patient, and terms for baseline value and the baseline-by-time interaction.||-26.4|-39.4|< 0.0001
72550672|NCT00437658|144631151|OTHER||Least squares mean|-35.8|||<|0.0001|TWO_SIDED|95.0|-43.0|-28.6||P-value for test of null hypothesis that the treatment group least squares mean is equal to zero.|t-test, 2 sided|||Within-group analysis of change from baseline in peak VAS for pelvic pain at week 24. Change from baseline was analyzed using a mixed-effects repeated measures (MERM) analysis of covariance model which included fixed effects for treatment, time, treatment-by-time interaction, a random effect for patient, and terms for baseline value and the baseline-by-time interaction.||-28.6|-43.0|< 0.0001
72550673|NCT00437658|144631152|OTHER||Least squares mean|-18.2|||<|0.0001|TWO_SIDED|95.0|-23.3|-13.1||P-value for test of null hypothesis that the treatment group least squares mean is equal to zero.|t-test, 2 sided|||Within-group analysis of change from baseline in monthly mean VAS for pelvic pain at week 24. Change from baseline was analyzed using a mixed-effects repeated measures (MERM) analysis of covariance model which included fixed effects for treatment, time, treatment-by-time interaction, a random effect for patient, and terms for baseline value and the baseline-by-time interaction.||-13.1|-23.3|< 0.0001
72550674|NCT00437658|144631152|OTHER||Least squares mean|-23.4|||<|0.0001|TWO_SIDED|95.0|-28.3|-18.5||P-value for test of null hypothesis that the treatment group least squares mean is equal to zero.|t-test, 2 sided|||Within-group analysis of change from baseline in monthly mean VAS for pelvic pain at week 24. Change from baseline was analyzed using a mixed-effects repeated measures (MERM) analysis of covariance model which included fixed effects for treatment, time, treatment-by-time interaction, a random effect for patient, and terms for baseline value and the baseline-by-time interaction.||-18.5|-28.3|< 0.0001
72550675|NCT00437658|144631152|OTHER||Least squares mean|-17.9|||<|0.0001|TWO_SIDED|95.0|-23.1|-12.7||P-value for test of null hypothesis that the treatment group least squares mean is equal to zero.|t-test, 2 sided|||Within-group analysis of change from baseline in peak VAS for pelvic pain at week 24. Change from baseline was analyzed using a mixed-effects repeated measures (MERM) analysis of covariance model which included fixed effects for treatment, time, treatment-by-time interaction, a random effect for patient, and terms for baseline value and the baseline-by-time interaction.||-12.7|-23.1|< 0.0001
72550676|NCT02731157|144631169|OTHER||Mean Difference (Final Values)|0.65||||0.95|TWO_SIDED||||||ANOVA|||||||0.95
72550677|NCT01014728|144631192|SUPERIORITY_OR_OTHER|||||||0.937||95.0|||||t-test, 2 sided|||||||0.937
72550678|NCT01014728|144631193|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.002
72550679|NCT01014728|144631194|SUPERIORITY_OR_OTHER|||||||0.461||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.461
72550680|NCT02781727|144631217|NON_INFERIORITY|Non-inferiority comparison with a non-inferiority margin of 2 cm/year, followed by a test of superiority if non-inferiority is established.||||||0.0088||||||P-value is based on a test of superiority|ANCOVA with multiple imputation|two-sided||ANCOVA model with multiple imputation. For each imputed data set, an ANCOVA model with by visit AHV as the dependent variable; treatment and gender as factors; and baseline age, baseline peak GH levels (log transformed) at stimulation test, and baseline height SDS - average parental height SDS as covariates were fitted.||||0.0088
72550681|NCT01918800|144631226|SUPERIORITY_OR_OTHER|||||||0.64||||||No adjustment for multiple comparisons. A priori threshold for clinical significance was 7 point improvement.|paired t test|||||||.64
72583453|NCT03985800|144697946|SUPERIORITY|We calculated statistical power for the target sample size of 675 (\~337 in each of TEAM and TECH arms). After adjusting for the multiple testing in Aim 1 (2 tests) and considering 25% attrition, a sample size of 505 (\~252 per treatment group) will provide over 99.9% power for the hypothesis test for Aim 1.|Type III Wald chi-squared|1.26||||0.53||||||The threshold for statistical significance was .05.|Mixed Models Analysis|The Chi-squared statistic for the group\*time interaction term is 1.26 with two degrees of freedom.||Null hypothesis: The trajectory of IBD complexity score does not differ by treatment group.||||0.53
72550682|NCT01918800|144631227|SUPERIORITY_OR_OTHER|||||||0.04||||||No adjustments for multiple comparisons.|paired t test|||||||0.04
72550683|NCT01918800|144631228|SUPERIORITY_OR_OTHER|||||||0.35||||||No adjustment for multiple comparisons|Paired t test|||||||0.35
72550684|NCT01918800|144631229|SUPERIORITY|||||||0.8||||||The p value in this case is for the SF-36 Physical|Wilcoxon (Mann-Whitney)|||||||0.8
72421535|NCT01181726|144354218|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|95.25|||||TWO_SIDED|90.0|91.18|99.51|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||99.51|91.18|
72550685|NCT01918800|144631229|SUPERIORITY|||||||0.09|||||||Wilcoxon (Mann-Whitney)|||The p value in this case refers to the SF-36 Mental||||.09
72550686|NCT01918800|144631230|SUPERIORITY_OR_OTHER|||||||0.521||||||This p value applies to the RAPA Cardiovascular|Wilcoxon (Mann-Whitney)|||||||0.521
72550687|NCT01918800|144631230|SUPERIORITY|||||||0.4199|||||||Wilcoxon (Mann-Whitney)|||This p values is for the RAPA Strength||||0.4199
72550688|NCT01918800|144631230|SUPERIORITY|||||||0.854|||||||Wilcoxon (Mann-Whitney)|||||||0.854
72550689|NCT01918800|144631231|SUPERIORITY_OR_OTHER|||||||0.42|||||||Wilcoxon (Mann-Whitney)|||||||0.42
72550690|NCT01918800|144631232|SUPERIORITY_OR_OTHER|||||||0.36|||||||Wilcoxon (Mann-Whitney)|||||||0.36
72550691|NCT02158936|144631301|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.37||||1|TWO_SIDED|95.0|0.21|0.65||One sided p value|Cochran-Mantel-Haenszel|Stratified by Interactive Voice Response System (IVRS) stratification factors||||0.65|0.21|1.000
72550692|NCT02158936|144631302|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.42||||0.164|TWO_SIDED|95.0|0.97|2.08|||Log Rank|||Confidence Intervals estimated using the Brookmeyer-Crowley method. Hazard ratios are estimated using the Pike estimator. A hazard ratio \<1 indicates a lower risk with eltrombopag compared with Placebo. Log-rank test stratified by IVRS stratification factors||2.08|0.97|0.164
72550693|NCT02158936|144631319|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.31|||||TWO_SIDED|90.0|0.99|1.74|||ANOVA|||||1.74|0.990|
72550694|NCT02158936|144631320|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.39|||||TWO_SIDED|90.0|0.97|1.99|||ANOVA|||||1.99|0.970|
72550695|NCT00366899|144631339|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of the 2-sided 95% CI for the difference between the two groups was \> -10%.|Difference|-0.4||||||95.0|-2.2|1.0||||||For Pertussis PT the difference in percentages between the two groups (13vPnC - 7vPnC) at ≥5 EU/mL threshold was calculated.||1.0|-2.2|
72583454|NCT03985800|144697946|SUPERIORITY|Considering a range of effect sizes for B1, B2, and B3, we estimated the outcome Y as Y=B1\*X+B2\*M+B3\*X\*M+ε, where ε\~N(0,1). Using Monte Carlo methods, we averaged across scenarios to determine the typical effect of B3 that can be detected with our current and projected sample sizes after 25% attrition. With our projected sample sizes we expect 0.80 power to detect a significant interaction when the magnitude of B3 is at least 0.50.|Type III Wald chi-squared|1.14||||0.57||||||The threshold for statistical significance was .05.|Mixed Models Analysis|The Chi-squared statistic for the group\*time\*age interaction term is 1.14 with two degrees of freedom.||Aim 2b., moderation by age. Null hypothesis: Age does not moderate the trajectory of complexity score by treatment group.||||0.57
72550696|NCT00366899|144631339|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of the 2-sided 95% CI for the difference between the two groups was \> -10%.|Difference|0.0||||||95.0|-4.0|3.8||||||For Pertussis PT the difference in percentages between the two groups (13vPnC - 7vPnC) at ≥16 EU/mL threshold was calculated.||3.8|-4.0|
72550697|NCT00366899|144631339|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of the 2-sided 95% CI for the difference between the two groups was \> -10%.|Difference|0.0||||||95.0|-1.6|1.4||||||For Pertussis FHA the difference in percentages between the two groups (13vPnC - 7vPnC) at ≥5 EU/mL threshold was calculated||1.4|-1.6|
72550698|NCT00366899|144631339|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of the 2-sided 95% CI for the difference between the two groups was \> -10%.|Difference|0.0||||||95.0|-1.6|1.4||||||For Pertussis FHA the difference in percentages between the two groups (13vPnC - 7vPnC) at ≥7.82 EU/mL threshold was calculated.||1.4|-1.6|
72550699|NCT00366899|144631339|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of the 2-sided 95% CI for the difference between the two groups was \> -10%.|Difference|-0.9||||||95.0|-5.0|2.9||||||For Pertussis FHA the difference in percentages between the two groups ( 13vPnC - 7vPnC) at ≥31 EU/mL threshold was calculated.||2.9|-5.0|
72550700|NCT00366899|144631339|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of the 2-sided 95% CI for the difference between the two groups was \> -10%.|Difference|0.0||||||95.0|-1.5|1.4||||||For Pertactin the difference in percentages between the two groups (13vPnC - 7vPnC) at ≥5 EU/mL threshold was calculated.||1.4|-1.5|
72550701|NCT00366899|144631339|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of the 2-sided 95% CI for the difference between the two groups was \> -10%.|Difference|-3.2||||||95.0|-7.8|1.0||||||For Pertactin the difference in percentages between the two groups ( 13vPnC - 7vPnC) at ≥40 EU/mL threshold was calculated.||1.0|-7.8|
72550702|NCT00366899|144631339|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of the 2-sided 95% CI for the difference between the two groups was \> -10%.|Difference|0.7||||||95.0|-3.6|5.0||||||For hepatitis B the difference in percentages between the two groups (13vPnC - 7vPnC) at ≥10.0 mIU/mL threshold was calculated.||5.0|-3.6|
72550703|NCT00366899|144631339|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of the 2-sided 95% CI for the difference between the two groups was \> -10%.|Difference|-3.2||||||95.0|-9.1|2.4||||||For Haemophilus influenzae type b the difference in percentages between the two groups (13vPnC - 7vPnC) at 0.15 μg/mL threshold was calculated.||2.4|-9.1|
72550704|NCT00366899|144631339|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of the 2-sided 95% CI for the difference between the two groups was \> -10%.|Difference|0.7||||||95.0|-8.2|9.5||||||For Haemophilus influenzae type b the difference in percentages between the two groups (13vPnC - 7vPnC) at 1.0 μg/mL threshold was calculated.||9.5|-8.2|
72550705|NCT00366899|144631339|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of the 2-sided 95% CI for the difference between the two groups was \> -10%.|Difference|0.0||||||95.0|-1.8|1.6||||||For Diptheria the difference in percentages between the two groups ( 13vPnC - 7vPnC) at 0.01 IU/mL threshold was calculated.||1.6|-1.8|
72550706|NCT00366899|144631339|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of the 2-sided 95% CI for the difference between the two groups was \> -10%.|Difference|-3.5||||||95.0|-8.3|0.8||||||For Diptheria the difference in percentage between the two groups ( 13vPnC - 7vPnC) at 0.1 IU/mL threshold was calculated.||0.8|-8.3|
72550707|NCT00366899|144631339|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of the 2-sided 95% CI for the difference between the two groups was \> -10%.|Difference|1.7||||||95.0|-3.9|7.1||||||For Tetanus the difference in percentage between the two groups ( 13vPnC - 7vPnC) at 0.1 IU/mL threshold was calculated.||7.1|-3.9|
72550708|NCT00366899|144631339|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of the 2-sided 95% CI for the difference between the two groups was \> -10%.|Difference|-0.1||||||95.0|-2.3|1.7||||||For Polio Type 1 the difference in percentage between the two groups (13vPnC - 7vPnC) at ≥1:8 threshold was calculated.||1.7|-2.3|
72583455|NCT03985800|144697946|SUPERIORITY|Considering a range of effect sizes for B1, B2, and B3, we estimated the outcome Y as Y=B1\*X+B2\*M+B3\*X\*M+ε, where ε\~N(0,1). Using Monte Carlo methods, we averaged across scenarios to determine the typical effect of B3 that can be detected with our current and projected sample sizes after 25% attrition. With our projected sample sizes we expect 0.80 power to detect a significant interaction when the magnitude of B3 is at least 0.50.|Type III Wald chi-squared|0.08||||0.96||||||The threshold for statistical significance was .05.|Mixed Models Analysis|The Chi-squared statistic for the group\*time\*diagnosis interaction term is 0.08 with two degrees of freedom.||Aim 2b., moderation by diagnosis. Null hypothesis: Diagnosis does not moderate the trajectory of complexity score by treatment group.||||0.96
72583456|NCT03985800|144697946|SUPERIORITY|Considering a range of effect sizes for B1, B2, and B3, we estimated the outcome Y as Y=B1\*X+B2\*M+B3\*X\*M+ε, where ε\~N(0,1). Using Monte Carlo methods, we averaged across scenarios to determine the typical effect of B3 that can be detected with our current and projected sample sizes after 25% attrition. With our projected sample sizes we expect 0.80 power to detect a significant interaction when the magnitude of B3 is at least 0.50.|Type III Wald chi-squared|6.41||||0.17||||||The threshold for statistical significance was .05.|Mixed Models Analysis|The Chi-squared statistic for the group\*time\*site interaction term is 6.41 with two degrees of freedom.||Aim 2b., moderation by site. Null hypothesis: Site does not moderate the trajectory of complexity score by treatment group.||||0.17
72583457|NCT03985800|144697946|SUPERIORITY|Considering a range of effect sizes for B1, B2, and B3, we estimated the outcome Y as Y=B1\*X+B2\*M+B3\*X\*M+ε, where ε\~N(0,1). Using Monte Carlo methods, we averaged across scenarios to determine the typical effect of B3 that can be detected with our current and projected sample sizes after 25% attrition. With our projected sample sizes we expect 0.80 power to detect a significant interaction when the magnitude of B3 is at least 0.50.|Type III Wald chi-squared|2.6||||0.27||||||The threshold for statistical significance was .05.|Mixed Models Analysis|The Chi-squared statistic for the group\*time\*site interaction term is 2.6 with two degrees of freedom.||Aim 2b., moderation by eHealth literacy. Null hypothesis: eHealth literacy does not moderate the trajectory of complexity score by treatment group.||||0.27
72583458|NCT03985800|144697947|SUPERIORITY|We calculated statistical power for the target sample size of 675 (\~337 in each of TEAM and TECH arms). After adjusting for the multiple testing in Aim 1 (2 tests) and considering 25% attrition, a sample size of 505 (\~252 per treatment group) will provide over 99.9% power for the hypothesis test for Aim 1.|Type III Wald chi-squared|0.21||||0.9||||||The threshold for statistical significance was .05.|Mixed Models Analysis|The Chi-squared statistic for the group\*time interaction term is 0.21 with two degrees of freedom.||Aim 1. The trajectory of PHQ-ADS does not differ by treatment group.||||0.90
72583459|NCT03985800|144697947|SUPERIORITY|Considering a range of effect sizes for B1, B2, and B3, we estimated the outcome Y as Y=B1\*X+B2\*M+B3\*X\*M+ε, where ε\~N(0,1). Using Monte Carlo methods, we averaged across scenarios to determine the typical effect of B3 that can be detected with our current and projected sample sizes after 25% attrition. With our projected sample sizes we expect 0.80 power to detect a significant interaction when the magnitude of B3 is at least 0.50.|Type III Wald chi-squared|1.21||||0.55||||||Threshold for statistical significance was 0.05.|Mixed Models Analysis|||Aim 2a, moderation by disease activity. Null hypothesis: Disease activity does not moderate the trajectory of behavioral health score by treatment group.||||0.55
72583460|NCT03985800|144697947|SUPERIORITY|Considering a range of effect sizes for B1, B2, and B3, we estimated the outcome Y as Y=B1\*X+B2\*M+B3\*X\*M+ε, where ε\~N(0,1). Using Monte Carlo methods, we averaged across scenarios to determine the typical effect of B3 that can be detected with our current and projected sample sizes after 25% attrition. With our projected sample sizes we expect 0.80 power to detect a significant interaction when the magnitude of B3 is at least 0.50.|Type III Wald chi-squared|1.37||||0.5||||||Threshold for statistical significance was 0.05.|Mixed Models Analysis|The Chi-squared statistic for the group\*time\*age interaction term is 1.37 with two degrees of freedom.||Aim 2b, moderation by age. Null hypothesis: Age does not moderate the trajectory of behavioral health score by treatment group.||||0.50
72412926|NCT00856583|144334374|NON_INFERIORITY_OR_EQUIVALENCE|If the upper limit of the 90% confidence interval (CI) for the estimated all-cause mortality ratio was \<1.5 (pre-specified), the null hypothesis was rejected. With this limit, 7,600 patient years of exposure (PYE) were required to ensure 80% power at the 5% significance level of rejecting the null hypothesis when assuming a mortality of 2 deaths per 100 PYE. As the actual mortality was only about half that anticipated, more exposure was necessary and the duration of the study increased markedly.|Hazard Ratio (HR)|1.117||||0.05|TWO_SIDED|90.0|0.831|1.5|||Cox Proportional Hazard|Adjusted for: age, sex, time since last suicide attempt, last previous antipsychotic treatment (mono-/polytherapy), year since start of enrollment.|The hazard ratio is calculated as sertindole (numerator) versus risperidone (denominator).|The basis for the statistical analysis of the first primary outcome was the null hypothesis of an excess mortality in sertindole-treated patients compared to the mortality in risperidone-treated patients for the WRT+30 days period.||1.500|0.831|0.05
72412927|NCT00856583|144334374|NON_INFERIORITY_OR_EQUIVALENCE|If the upper limit of the 90% CI for the estimated all-cause mortality ratio was \<1.5 (pre-specified), the null hypothesis was rejected. With this limit, 7,600 PYE were required to ensure 80% power at the 5% significance level of rejecting the null hypothesis when assuming a mortality of 2 deaths per 100 PYE. As the actual mortality was only about half that anticipated, more exposure was necessary and the duration of the study increased markedly.|Hazard Ratio (HR)|0.98|||<|0.05|TWO_SIDED|90.0|0.684|1.405|||Cox Proportional Hazard|Adjusted for: age, sex, time since last suicide attempt, last previous antipsychotic treatment (mono-/polytherapy), year since start of enrollment.|The hazard ratio is calculated as sertindole (numerator) versus risperidone (denominator).|The basis for the statistical analysis of the first primary outcome was the null hypothesis of an excess mortality in sertindole-treated patients compared to the mortality in risperidone-treated patients for the ORT period.||1.405|0.684|<0.05
72412928|NCT00856583|144334375|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.84||||0.0022|TWO_SIDED|95.0|1.45|5.55|||Cox Proportional Hazard|Adjusted: age, sex, time since last suicide attempt, last previous antipsychotic treatment (mono-/polytherapy), region, year since start of enrollment||The basis for the statistical analysis of this secondary outcome was the null hypothesis of mortality hazard ratio equal to 1 for the sertindole-treated patients versus risperidone-treated patients during the WRT+30 days period.||5.55|1.45|0.0022
72412929|NCT00856583|144334376|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.73||||0.29|TWO_SIDED|95.0|0.63|4.78|||Cox Proportional Hazard|Adjusted for: age and sex.||The basis for the statistical analysis of time to 1st occurence of the secondary primary outcome (one patient in the risperidone group reported more than one occurrence of this event) was the null hypothesis of hazard ratio equal to 1 for the sertindole-treated patients versus risperidone-treated patients during the WRT+30 days period.||4.78|0.63|0.29
72550709|NCT00366899|144631339|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of the 2-sided 95% CI for the difference between the two groups was \> -10%.|Difference|-1.0||||||95.0|-5.0|2.8||||||For Polio Type 2 the difference in percentage between the two groups ( 13vPnC - 7vPnC) at ≥1:8 threshold was calculated.||2.8|-5.0|
72550710|NCT00366899|144631339|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of the 2-sided 95% CI for the difference between the two groups was \> -10%.|Difference|0.7||||||95.0|-1.6|2.9||||||For Polio Type 3 the difference in percentages between the two groups (13vPnC - 7vPnC) at ≥1:8 threshold was calculated.||2.9|-1.6|
72550711|NCT00366899|144631339|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of the 2-sided 95% CI for the difference between the two groups was \> -10%.|Difference|0.0||||||95.0|-1.6|1.7||||||For Pertussis PT the difference in percentages between the two groups (13vPnC - 7vPnC) at ≥5 EU/mL threshold was calculated||1.7|-1.6|
72550712|NCT00366899|144631339|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of the 2-sided 95% CI for the difference between the two groups was \> -10%.|Difference|-2.7||||||95.0|-7.3|1.8||||||For Pertussis PT the difference in percentages between the two groups (13vPnC - 7vPnC) at ≥21 EU/mL threshold was calculated.||1.8|-7.3|
72550713|NCT00366899|144631339|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of the 2-sided 95% CI for the difference between the two groups was \> -10%.|Difference|0.0||||||95.0|-1.6|1.7||||||For Pertussis FHA the difference in percentages between the two groups (13vPnC - 7vPnC) at ≥5 EU/mL threshold was calculated||1.7|-1.6|
72583461|NCT03985800|144697947|SUPERIORITY|Considering a range of effect sizes for B1, B2, and B3, we estimated the outcome Y as Y=B1\*X+B2\*M+B3\*X\*M+ε, where ε\~N(0,1). Using Monte Carlo methods, we averaged across scenarios to determine the typical effect of B3 that can be detected with our current and projected sample sizes after 25% attrition. With our projected sample sizes we expect 0.80 power to detect a significant interaction when the magnitude of B3 is at least 0.50.|Type III Wald chi-squared|5.16||||0.08||||||Threshold for statistical significance was 0.05.|Mixed Models Analysis|The Chi-squared statistic for the group\*time\*diagnosis interaction term is 5.16 with two degrees of freedom.||Aim 2b, moderation by diagnosis. Null hypothesis: Diagnosis does not moderate the trajectory of behavioral health score by treatment group.||||0.08
72550714|NCT00366899|144631339|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of the 2-sided 95% CI for the difference between the two groups was \> -10%.|Difference|0.0||||||95.0|-1.6|1.7||||||For Pertussis FHA the difference in percentages between the two groups (13vPnC - 7vPnC) at ≥7.82 EU/mL threshold was calculated||1.7|-1.6|
72550715|NCT00366899|144631339|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of the 2-sided 95% CI for the difference between the two groups was \> -10%.|Difference|-0.1||||||95.0|-4.3|4.1||||||For Pertussis FHA the difference in percentages between the two groups (13vPnC - 7vPnC) at ≥162 EU/mL threshold was calculated||4.1|-4.3|
72583462|NCT03985800|144697947|SUPERIORITY|Considering a range of effect sizes for B1, B2, and B3, we estimated the outcome Y as Y=B1\*X+B2\*M+B3\*X\*M+ε, where ε\~N(0,1). Using Monte Carlo methods, we averaged across scenarios to determine the typical effect of B3 that can be detected with our current and projected sample sizes after 25% attrition. With our projected sample sizes we expect 0.80 power to detect a significant interaction when the magnitude of B3 is at least 0.50.|Type III Wald chi-squared|0.11||||1||||||Threshold for statistical significance was 0.05.|Mixed Models Analysis|The Chi-squared statistic for the group\*time\*site interaction term is 0.11 with two degrees of freedom.||Aim 2b, moderation by site. Null hypothesis: Site does not moderate the trajectory of behavioral health score by treatment group.||||1.0
72412930|NCT00856583|144334377|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.72||||0.34|TWO_SIDED|95.0|0.36|1.41|||Cox Proportional Hazard|Adjusted for: age, sex, time since last suicide attempt, last previous antipsychotic treatment (mono-/polytherapy), year since start of enrollment.||The basis for the statistical analysis of this secondary outcome was the null hypothesis of mortality hazard ratio equal to 1 for the sertindole-treated patients versus risperidone-treated patients during the WRT+30 days period.||1.41|0.36|0.34
72412931|NCT00856583|144334378|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.715||||0.26|TWO_SIDED|95.0|0.4|1.28|||Cox Proportional Hazard|Adjusted for: age, sex, last previous antipsychotic treatment (mono-/polytherapy), year since start of enrollment.||The basis for the statistical analysis of this secondary outcome was the null hypothesis of mortality hazard ratio equal to 1 for the sertindole-treated patients versus risperidone-treated patients during the WRT+30 days period.||1.28|0.40|0.26
72412932|NCT00856583|144334379|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.13||||0.081|TWO_SIDED|95.0|0.91|4.98|||Cox Proportional Hazard|Adjusted for: age, sex, last previous antipsychotic treatment (mono-/polytherapy).||The basis for the statistical analysis of this secondary outcome was the null hypothesis of mortality hazard ratio equal to 1 for the sertindole-treated patients versus risperidone-treated patients during the WRT+30 days period.||4.98|0.91|0.081
72412933|NCT00856583|144334380|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.66||||0.24|TWO_SIDED|95.0|0.33|1.32|||Cox Proportional Hazard|Adjusted for: age, sex, time since last suicide attempt, last previous antipsychotic treatment (mono-/polytherapy), year since start of enrollment.||The basis for the statistical analysis of this secondary outcome was the null hypothesis of mortality hazard ratio equal to 1 for the sertindole-treated patients versus risperidone-treated patients during the WRT+30 days period.||1.32|0.33|0.24
72412934|NCT00856583|144334381|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.14||||0.59|TWO_SIDED|95.0|0.7|1.85|||Cox Proportional Hazard|Adjusted for: age, sex, last previous antipsychotic treatment (mono-/polytherapy), year since start of enrollment.||The basis for the statistical analysis of this secondary outcome was the null hypothesis of mortality hazard ratio equal to 1 for the sertindole-treated patients versus risperidone-treated patients during the WRT+30 days period.||1.85|0.70|0.59
72550716|NCT00366899|144631339|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of the 2-sided 95% CI for the difference between the two groups was \> -10%.|Difference|0.0||||||95.0|-1.6|1.7||||||For Pertactin the difference in percentages between the two groups (13vPnC - 7vPnC) at ≥5 EU/mL threshold was calculated.||1.7|-1.6|
72550717|NCT00366899|144631339|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of the 2-sided 95% CI for the difference between the two groups was \> -10%.|Difference|-0.5||||||95.0|-4.7|3.7||||||For Pertactin the difference in percentages between the two groups (13vPnC - 7vPnC) at ≥106 EU/mL threshold was calculated.||3.7|-4.7|
72550718|NCT00366899|144631339|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of the 2-sided 95% CI for the difference between the two groups was \> -10%.|Difference|-0.4||||||95.0|-3.0|2.0||||||For hepatitis B the difference in percentages between the two groups (13vPnC - 7vPnC) at ≥10.0 mIU/mL threshold was calculated.||2.0|-3.0|
72550719|NCT00366899|144631339|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of the 2-sided 95% CI for the difference between the two groups was \> -10%.|Difference|1.4||||||95.0|-0.8|4.2||||||For Haemophilus influenzae type b the difference in percentage between the two groups (13vPnC - 7vPnC) at 0.15 μg/mL threshold was calculated||4.2|-0.8|
72550720|NCT00366899|144631339|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of the 2-sided 95% CI for the difference between the two groups was \> -10%.|Difference|4.0||||||95.0|-0.4|8.7||||||For Haemophilus influenzae type b the difference in percentage between the two groups (13vPnC - 7vPnC) at 1.0 μg/mL threshold was calculated.||8.7|-0.4|
72550721|NCT00366899|144631339|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of the 2-sided 95% CI for the difference between the two groups was \> -10%.|Difference|0.0||||||95.0|-2.3|2.0||||||For Diphtheria the difference in percentages between the two groups (13vPnC - 7vPnC) at 0.01 IU/mL threshold was calculated.||2.0|-2.3|
72550722|NCT00366899|144631339|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of the 2-sided 95% CI for the difference between the two groups was \> -10%.|Difference|0.0||||||95.0|-2.3|2.0||||||For Diphtheria the difference in percentages between the two groups (13vPnC - 7vPnC) at 0.1 IU/mL threshold was calculated||2.0|-2.3|
72550723|NCT00366899|144631339|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of the 2-sided 95% CI for the difference between the two groups was \> -10%.|Difference|3.8||||||95.0|-1.7|10.9||||||For Tetanus the difference in percentages between the two groups (13vPnC - 7vPnC) at 0.1 IU/mL threshold was calculated.||10.9|-1.7|
72550724|NCT00366899|144631339|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of the 2-sided 95% CI for the difference between the two groups was \> -10%.|Difference|0.0||||||95.0|-2.4|2.1||||||For Polio Type 1 the difference in percentage between the two groups (13vPnC - 7vPnC) at ≥1:8 threshold was calculated.||2.1|-2.4|
72550725|NCT00366899|144631339|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of the 2-sided 95% CI for the difference between the two groups was \> -10%.|Difference|0.0||||||95.0|-2.4|2.1||||||For Polio Type 2 the difference in percentage between the two groups (13vPnC - 7vPnC) at ≥1:8 threshold was calculated.||2.1|-2.4|
72550726|NCT00366899|144631339|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of the 2-sided 95% CI for the difference between the two groups was \> -10%.|Difference|0.0||||||95.0|-2.4|2.1||||||For Polio Type 3 the difference in percentage between the two groups (13vPnC - 7vPnC) at ≥1:8 threshold was calculated.||2.1|-2.4|
72550727|NCT00366899|144631340|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC/GMT ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|0.98||||||95.0|0.87|1.1||||||For Pertussis FHA the GMC ratio (13vPnC/7vPnC) was calculated||1.10|0.87|
72412935|NCT00856583|144334382|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.93||||0.65|TWO_SIDED|95.0|0.66|1.29|||Cox Proportional Hazard|Adjusted for: age, sex, duration of schizophrenia, time since last suicide attempt, year since start of enrollment.||The basis for the statistical analysis of time to 1st occurence of this secondary outcome was the null hypothesis of hazard ratio equal to 1 for the sertindole-treated patients versus risperidone-treated patients during the WRT+30 days period.||1.29|0.66|0.65
72412936|NCT00856583|144334383|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.67||||0.044|TWO_SIDED|95.0|0.45|0.99|||Cox Proportional Hazard|Adjusted for: age, sex, duration of schizophrenia, time since last suicide attempt, year since start of enrollment.||The basis for the statistical analysis of time to 1st occurence of this secondary outcome was the null hypothesis of hazard ratio equal to 1 for the sertindole-treated patients versus risperidone-treated patients during the WRT+30 days period.||0.99|0.45|0.044
72412937|NCT00856583|144334384|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.26||||0.04|TWO_SIDED|95.0|1.01|1.57|||Cox Proportional Hazard|Adjusted for: age, sex, time since last suicide attempt, last antipsychotic medication (a-/typicals/both), region, year since start of enrollment.||The basis for the statistical analysis of time to 1st occurence of this secondary outcome was the null hypothesis of hazard ratio equal to 1 for the sertindole-treated patients versus risperidone-treated patients during the WRT+30 days period.||1.57|1.01|0.040
72412938|NCT00856583|144334385|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.35|||<|0.0001|TWO_SIDED|95.0|1.28|1.43|||Cox Proportional Hazard|Adjusted: disease duration, time since last suicide attempt, last antipsychotic medication (a-/typicals/both), region, year since start of enrollment.||The basis for the statistical analysis of this secondary outcome was the null hypothesis of hazard ratio equal to 1 for the sertindole-treated patients versus risperidone-treated patients during the WRT+30 days period.||1.43|1.28|<0.0001
72412939|NCT01944046|144334389|SUPERIORITY|||||||0.503||||||not adjusted primary outcome|Mixed Models Analysis|adjusted for baseline, age category, functionality category||||||0.503
72412940|NCT01944046|144334390|SUPERIORITY|||||||0.61||||||not adjusted primary outcome, p threshold 0.05|Mixed Models Analysis|adjustment for value at week 24,||||||0.61
72412941|NCT00823082|144334405|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|||||||<0.0001
72550728|NCT00366899|144631340|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC/GMT ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|1.03||||||95.0|0.92|1.16||||||For Pertussis PT the GMC ratio (13vPnC/7vPnC) was calculated||1.16|0.92|
72550729|NCT00366899|144631340|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC/GMT ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|1.01||||||95.0|0.87|1.17||||||For Pertussis PRN the GMC ratio (13vPnC/7vPnC) was calculated||1.17|0.87|
72583463|NCT03985800|144697947|SUPERIORITY|Considering a range of effect sizes for B1, B2, and B3, we estimated the outcome Y as Y=B1\*X+B2\*M+B3\*X\*M+ε, where ε\~N(0,1). Using Monte Carlo methods, we averaged across scenarios to determine the typical effect of B3 that can be detected with our current and projected sample sizes after 25% attrition. With our projected sample sizes we expect 0.80 power to detect a significant interaction when the magnitude of B3 is at least 0.50.|Type III Wald chi-squared|3.23||||0.2||||||Threshold for statistical significance was 0.05|Mixed Models Analysis|The Chi-squared statistic for the group\*time\*eHealth literacy interaction term is 3.23 with two degrees of freedom.||Aim 2b, moderation by eHealth literacy. Null hypothesis: eHealth literacy does not moderate the trajectory of behavioral health score by treatment group.||||0.20
72583464|NCT03985800|144697948|SUPERIORITY|Considering a range of effect sizes for B1, B2, and B3, we estimated the outcome Y as Y=B1\*X+B2\*M+B3\*X\*M+ε, where ε\~N(0,1). Using Monte Carlo methods, we averaged across scenarios to determine the typical effect of B3 that can be detected with our current and projected sample sizes after 25% attrition. With our projected sample sizes we expect 0.80 power to detect a significant interaction when the magnitude of B3 is at least 0.50.|Type III Wald chi-squared|3.09||||0.53||||||The threshold for statistical significance was .05.|Mixed Models Analysis|The Chi-squared statistic for the group\*time interaction term is 3.09 with two degrees of freedom.||Null hypothesis: The trajectory of functional impairment does not differ by treatment group.||||0.53
72583465|NCT03985800|144697949|SUPERIORITY|We calculated statistical power for the target sample size of 675 (\~337 in each of TEAM and TECH arms). After adjusting for the multiple testing in Aim 1 (2 tests) and considering 25% attrition, a sample size of 505 (\~252 per treatment group) will provide over 99.9% power for the hypothesis test for Aim 1.|Type III Wald chi-squared|6.01||||0.05||||||The threshold for statistical significance was .05.|Mixed Models Analysis|The Chi-squared statistic for the group\*time interaction term is 6.01 with two degrees of freedom.||Null hypothesis: The trajectory of IBD-IBS symptom severity does not differ by treatment group.||||0.05
72583466|NCT03985800|144697950|SUPERIORITY|We calculated statistical power for the target sample size of 675 (\~337 in each of TEAM and TECH arms). After adjusting for the multiple testing in Aim 1 (2 tests) and considering 25% attrition, a sample size of 505 (\~252 per treatment group) will provide over 99.9% power for the hypothesis test for Aim 1.|Type III Wald chi-squared|4.14||||0.13||||||The threshold for statistical significance was .05.|Mixed Models Analysis|For hospitalizations, the Chi-squared statistic for the group\*time interaction term is 4.14 with two degrees of freedom||Null hypothesis: The trajectory of hospitalizations does not differ by treatment group.||||0.13
72412942|NCT00823082|144334406|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Fisher Exact|||||||<0.0001
72550730|NCT00366899|144631340|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC/GMT ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|1.01||||||95.0|0.89|1.15||||||For Pertussis FHA the GMC ratio (13vPnC/7vPnC) was calculated||1.15|0.89|
72412943|NCT00823082|144334407|SUPERIORITY_OR_OTHER|||||||0.6115|TWO_SIDED||||||Fisher Exact|||At ICU discharge visit||||0.6115
72412944|NCT00823082|144334408|SUPERIORITY_OR_OTHER|||||||0.1211|TWO_SIDED||||||Fisher Exact|||Follow-up visit||||0.1211
72412945|NCT00823082|144334408|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Fisher Exact|||ICU discharge visit||||1.000
72412946|NCT00823082|144334409|SUPERIORITY_OR_OTHER|||||||0.487|TWO_SIDED||||||Fisher Exact|||ICU discharge visit||||0.4870
72412947|NCT00823082|144334410|SUPERIORITY_OR_OTHER|||||||0.3897|TWO_SIDED||||||Hodges-Lehmann test|||||||0.3897
72550731|NCT00366899|144631340|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC/GMT ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|0.94||||||95.0|0.83|1.07||||||For Pertussis PT the GMC ratio (13vPnC/7vPnC) was calculated||1.07|0.83|
72412948|NCT00823082|144334411|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Fisher Exact|||||||1.0000
72550732|NCT00366899|144631340|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC/GMT ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|0.94||||||95.0|0.82|1.07||||||For Pertussis PRN the GMC ratio (13vPnC/7vPnC) was calculated||1.07|0.82|
72550733|NCT00366899|144631343|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the geometric mean concentration (GMC)/geometric mean titer (GMT) ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|0.96||||||95.0|0.72|1.27||||||For Hepatitis b the geometric mean concentration (GMC) ratio (13vPnC/7vPnC) was calculated||1.27|0.72|
72550734|NCT00366899|144631343|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC/GMT ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|0.72||||||95.0|0.54|0.96||||||For Hepatitis b the GMC ratio (13vPnC/7vPnC) was calculated||0.96|0.54|
72550735|NCT00366899|144631344|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC/GMT ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|0.99||||||95.0|0.75|1.3||||||or Haemophilus influenzae type b the GMC ratio (13vPnC/7vPnC) was calculated||1.30|0.75|
72550736|NCT00366899|144631344|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC/GMT ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|1.03||||||95.0|0.81|1.3||||||For Haemophilus influenzae type b the GMC ratio (13vPnC/7vPnC) was calculated||1.30|0.81|
72550737|NCT00366899|144631345|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC/GMT ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|0.78||||||95.0|0.65|0.94||||||For diphtheria toxoid the GMC ratio (13vPnC/7vPnC) was calculated||0.94|0.65|
72550738|NCT00366899|144631345|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC/GMT ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|0.85||||||95.0|0.67|1.08||||||For Tetanus the GMC ratio (13vPnC/7vPnC) was calculated||1.08|0.67|
72550739|NCT00366899|144631345|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC/GMT ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|0.75||||||95.0|0.63|0.89||||||For diphtheria toxoid the GMC ratio (13vPnC/7vPnC) was calculated||0.89|0.63|
72583467|NCT03985800|144697950|SUPERIORITY|We calculated statistical power for the target sample size of 675 (\~337 in each of TEAM and TECH arms). After adjusting for the multiple testing in Aim 1 (2 tests) and considering 25% attrition, a sample size of 505 (\~252 per treatment group) will provide over 99.9% power for the hypothesis test for Aim 1.|Type III Wald chi-squared|0.82||||0.67||||||The threshold for statistical significance was .05.|Mixed Models Analysis|For ED visits, the Chi-squared statistic for the group\*time interaction term is 0.82 with two degrees of freedom.||Null hypothesis: The trajectory of ED visits does not differ by treatment group.||||0.67
72583468|NCT03985800|144697951|SUPERIORITY|We calculated statistical power for the target sample size of 675 (\~337 in each of TEAM and TECH arms). After adjusting for the multiple testing in Aim 1 (2 tests) and considering 25% attrition, a sample size of 505 (\~252 per treatment group) will provide over 99.9% power for the hypothesis test for Aim 1.|Type III Wald chi-squared|1.98||||0.37||||||The threshold for statistical significance was .05.|Mixed Models Analysis|The Chi-squared statistic for the group\*time interaction term is 1.98 with two degrees of freedom.||Null hypothesis: The trajectory of self-efficacy does not differ by treatment group.||||0.37
72412949|NCT00823082|144334412|SUPERIORITY_OR_OTHER|||||||0.0004|TWO_SIDED||||||Fisher Exact|||||||0.0004
72412950|NCT00823082|144334413|SUPERIORITY_OR_OTHER|||||||0.0209|TWO_SIDED||||||ANCOVA|||||||0.0209
72412951|NCT00823082|144334414|SUPERIORITY_OR_OTHER|||||||0.7433|TWO_SIDED||||||ANCOVA|||Number of units of packed red blood cells||||0.7433
72412952|NCT00823082|144334414|SUPERIORITY_OR_OTHER|||||||0.7453|TWO_SIDED||||||ANCOVA|||Units of fresh frozen plasma||||0.7453
72412953|NCT00823082|144334414|SUPERIORITY_OR_OTHER|||||||0.2705|TWO_SIDED||||||ANCOVA|||Units of platelets||||0.2705
72412954|NCT00823082|144334415|SUPERIORITY_OR_OTHER|||||||0.446|TWO_SIDED||||||Fisher Exact|||||||0.4460
72550740|NCT00366899|144631345|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC/GMT ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|1.25||||||95.0|0.88|1.79||||||For Tetanus the GMC ratio (13vPnC/7vPnC) was calculated||1.79|0.88|
72550741|NCT00366899|144631346|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC/GMT ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|0.87||||||95.0|0.7|1.08||||||For Polio Type 1 the GMC ratio (13vPnC/7vPnC) was calculated||1.08|0.70|
72412955|NCT00823082|144334416|SUPERIORITY_OR_OTHER|||||||0.4936|TWO_SIDED||||||Fisher Exact|||||||0.4936
72412956|NCT00823082|144334417|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Fisher Exact|||Follow-up visit||||1.000
72412957|NCT00823082|144334417|SUPERIORITY_OR_OTHER|||||||0.6218|TWO_SIDED||||||Fisher Exact|||ICU discharge visit||||0.6218
72412958|NCT00823082|144334418|SUPERIORITY_OR_OTHER|||||||0.9574|TWO_SIDED||||||Hodges-Lehmann|||||||0.9574
72550742|NCT00366899|144631346|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC/GMT ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|0.95||||||95.0|0.74|1.22||||||For Polio Type 2 the GMC ratio (13vPnC/7vPnC) was calculated||1.22|0.74|
72550743|NCT00366899|144631346|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC/GMT ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|0.88||||||95.0|0.68|1.13||||||For Polio Type 3 the GMC ratio (13vPnC/7vPnC) was calculated||1.13|0.68|
72583469|NCT03985800|144697952|SUPERIORITY|We calculated statistical power for the target sample size of 675 (\~337 in each of TEAM and TECH arms). After adjusting for the multiple testing in Aim 1 (2 tests) and considering 25% attrition, a sample size of 505 (\~252 per treatment group) will provide over 99.9% power for the hypothesis test for Aim 1.|Type III Wald chi-squared|5.57||||0.06||||||The threshold for statistical significance was .05.|Mixed Models Analysis|The Chi-squared statistic for the group\*time interaction term is 5.57 with two degrees of freedom.||Null hypothesis: The trajectory of quality of life does not differ by treatment group.||||0.06
72550744|NCT00366899|144631346|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC/GMT ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|0.69||||||95.0|0.55|0.86||||||For Polio Type 1 the GMC ratio (13vPnC/7vPnC) was calculated||0.86|0.55|
72583470|NCT04281485|144697972|SUPERIORITY||Least Square Mean Difference|0.09|STANDARD_ERROR_OF_MEAN|0.78|=|0.9116|TWO_SIDED|95.0|-1.46|1.64|||Mixed Models Analysis||||The Mixed Model Repeated Measures (MMRM) model contained fixed effects for treatment group (categorical variable), visit (ordered categorical variable), and treatment group by visit interaction with additional fixed effects for baseline value (continuous variable), screening age (continuous variable), baseline value by visit interaction, and screening age by visit interaction with an unstructured variance-covariance matrix.|1.64|-1.46|=0.9116
72583471|NCT04281485|144697973|SUPERIORITY||Least Square Mean Difference|85.75|STANDARD_ERROR_OF_MEAN|17.17|=|0.0002|TWO_SIDED|95.0|49.15|122.35|||ANCOVA|The ANCOVA model contained treatment group (categorical variable) and screening age (continuous variable).||||122.35|49.15|=0.0002
72583472|NCT04281485|144697974|SUPERIORITY||Least Square Mean Difference|51.46|STANDARD_ERROR_OF_MEAN|9.49|<|0.0001|TWO_SIDED|95.0|31.43|71.49|||ANCOVA|The ANCOVA model contained treatment group (categorical variable) and screening age (continuous variable).||||71.49|31.43|<0.0001
72583473|NCT04281485|144697975|SUPERIORITY||Geometric Ratio of LS Means|0.64|||=|0.0002|TWO_SIDED|95.0|0.5|0.81|||Mixed Models Analysis||||MMRM approach for log transformed data including visits through Week 52 where serum CK concentration was assessed with fixed effects for treatment group (categorical variable), visit (ordered categorical variable), and treatment group by visit interaction, and with additional fixed effects for natural log of baseline (continuous variable), screening age covariate (continuous variable), natural log of baseline by visit interaction, and screening age covariate by visit interaction with an unstructured variance-covariance matrix.|0.81|0.50|=0.0002
72583474|NCT04281485|144697976|SUPERIORITY||Odds Ratio (OR)|1.73|||=|0.2784|TWO_SIDED|95.0|0.64|4.62|||Binomial regression||||The generalized mixed linear model assumed a binomial distribution with logit link \& contains fixed effects for treatment group (categorical variable) \& screening age (continuous variable).|4.62|0.64|=0.2784
72583475|NCT04281485|144697977|SUPERIORITY||Odds Ratio (OR)|0.9|||=|0.5437|TWO_SIDED|95.0|0.63|1.28|||Binomial Regression||||The generalized mixed linear model assumed a binomial distribution with a logit link and contained fixed effects for treatment group (categorical variable) and screening age (continuous variable).|1.28|0.63|=0.5437
72583476|NCT04281485|144697978|SUPERIORITY||Least Square Mean Difference|-0.079|STANDARD_ERROR_OF_MEAN|0.082|=|0.3343|TWO_SIDED|95.0|-0.242|0.083|||Mixed Models Analysis||||The MMRM model contained fixed effects for treatment group (categorical variable), visit (ordered categorical variable), and treatment group by visit interaction with additional fixed effects for baseline value (continuous variable), screening age (continuous variable), baseline value by visit interaction, and screening age by visit interaction with an unstructured variance-covariance matrix.|0.083|-0.242|=0.3343
72583477|NCT04281485|144697979|SUPERIORITY||Least Square Mean Difference|-0.004|STANDARD_ERROR_OF_MEAN|0.024|=|0.8826|TWO_SIDED|95.0|-0.052|0.045|||Mixed Models Analysis||||The MMRM model contained fixed effects for treatment group (categorical variable), visit (ordered categorical variable), and treatment group by visit interaction with additional fixed effects for baseline value (continuous variable), screening age (continuous variable), baseline value by visit interaction, and screening age by visit interaction with an unstructured variance-covariance matrix.|0.045|-0.052|=0.8826
72583478|NCT04281485|144697980|SUPERIORITY||Least Square Mean Difference|2.01|STANDARD_ERROR_OF_MEAN|1.63|=|0.219|TWO_SIDED|95.0|-1.22|5.24|||Mixed Models Analysis||||The MMRM model contained fixed effects for treatment group (categorical variable), visit (ordered categorical variable), and treatment group by visit interaction with additional fixed effects for baseline value (continuous variable), screening age (continuous variable), baseline value by visit interaction, and screening age by visit interaction with an unstructured variance-covariance matrix.|5.24|-1.22|=0.2190
72583479|NCT04281485|144697981|SUPERIORITY||Least Square Mean Difference|1.11|STANDARD_ERROR_OF_MEAN|2.96|=|0.7096||95.0|-4.79|7.0|||Mixed Models Analysis||||The MMRM model contained fixed effects for treatment group (categorical variable), visit (ordered categorical variable), and treatment group by visit interaction with additional fixed effects for baseline value (continuous variable), screening age (continuous variable), baseline value by visit interaction, and screening age by visit interaction with an unstructured variance-covariance matrix.|7.00|-4.79|=0.7096
72583480|NCT00127231|144697982|EQUIVALENCE||Odds Ratio (OR)|0.42|||<|0.005|TWO_SIDED|95.0|0.23|0.75|||Mixed Models Analysis|||Drinking frequency was analyzed using a generalized binomial mixed-effects model with the logit link function and a random intercept. The use of a binomial distribution was indicated for this analysis because the outcome was assessed using a 90-day TLFB interview, which has a cap at 90 days.||0.75|0.23|<0.005
72412959|NCT00823082|144334419|SUPERIORITY_OR_OTHER|||||||0.7489|||||||Hodges-Lehmann test|||||||0.7489
72550745|NCT00366899|144631346|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC/GMT ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|0.85||||||95.0|0.68|1.07||||||For Polio Type 2 the GMC ratio (13vPnC/7vPnC) was calculated||1.07|0.68|
72412960|NCT03198000|144334424|EQUIVALENCE|Prespecified equivalence interval of (-0.22, 0.44).|Mean Difference (Final Values)|-0.04|STANDARD_ERROR_OF_MEAN|0.049||0.392|TWO_SIDED|95.0|-0.14|0.055|||ANCOVA|Mixed effect ANCOVA with treatment as factor and baseline value as a covariate.||||0.055|-0.140|0.392
72412961|NCT03198000|144334424|EQUIVALENCE|Prespecified equivalence interval of (-0.22, 0.44)|Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.049||0.828|TWO_SIDED|95.0|-0.086|0.107|||ANCOVA|Mixed effect ANCOVA with treatment as factor and baseline value as a covariate.||||0.107|-0.086|0.828
72583481|NCT03096314|144697987|SUPERIORITY|||||||0.26|||||||Generalized linear model|||||||0.26
72583482|NCT03096314|144697988|SUPERIORITY||Risk Difference (RD)|4.3|||||TWO_SIDED|95.0|-0.1|8.6||||||||8.6|-0.1|
72583483|NCT03096314|144697989|SUPERIORITY||Risk Difference (RD)|3.7|||||TWO_SIDED|95.0|-0.5|8.0||||||||8.0|-0.5|
72583484|NCT03096314|144697990|SUPERIORITY||Risk Difference (RD)|0.3|||||TWO_SIDED|95.0|-5.4|6.0||||||||6.0|-5.4|
72583485|NCT03096314|144697991|SUPERIORITY||Mean Difference (Final Values)|-1.4|||||TWO_SIDED|95.0|-2.7|0.0||||||||0.0|-2.7|
72583486|NCT03096314|144697992|SUPERIORITY||Mean Difference (Final Values)|-2.2|||||TWO_SIDED|95.0|-4.8|0.4||||||||0.4|-4.8|
72583487|NCT03096314|144697993|SUPERIORITY||Mean Difference (Final Values)|-0.8|||||TWO_SIDED|95.0|-2.1|0.5||||||||0.5|-2.1|
72583488|NCT03096314|144697994|SUPERIORITY||Mean Difference (Final Values)|0.0|||||TWO_SIDED|95.0|0.0|0.1||||||||0.1|0|
72583489|NCT03096314|144697995|SUPERIORITY||Risk Difference (RD)|0.7|||||TWO_SIDED|95.0|-2.1|3.6||||||||3.6|-2.1|
72583490|NCT03096314|144697996|SUPERIORITY||Risk Difference (RD)|6.5|||||TWO_SIDED|95.0|-22.0|34.9||||||Mild ARDS||34.9|-22.0|
72583491|NCT03096314|144697996|SUPERIORITY||Risk Difference (RD)|-25.6|||||TWO_SIDED|95.0|-56.3|5.1||||||Moderate ARDS||5.1|-56.3|
72583492|NCT03096314|144697996|SUPERIORITY||Risk Difference (RD)|19.1|||||TWO_SIDED|95.0|-2.9|41.1||||||Severe ARDS||41.1|-2.9|
72583493|NCT03096314|144697997|SUPERIORITY||Risk Difference (RD)|-1.1|||||TWO_SIDED|95.0|-7.3|5.0||||||No AKI||5.0|-7.3|
72583494|NCT03096314|144697997|SUPERIORITY||Risk Difference (RD)|-1.1|||||TWO_SIDED|95.0|-5.6|3.4||||||Mild AKI||3.4|-5.6|
72583495|NCT03096314|144697997|SUPERIORITY||Risk Difference (RD)|-0.6|||||TWO_SIDED|95.0|-4.4|3.2||||||Moderate AKI||3.2|-4.4|
72583496|NCT03096314|144697997|SUPERIORITY||Risk Difference (RD)|2.8|||||TWO_SIDED|95.0|-1.7|7.3||||||Severe AKI||7.3|-1.7|
72583497|NCT03096314|144697998|SUPERIORITY||Risk Difference (RD)|0.5|||||TWO_SIDED|95.0|-1.9|2.9||||||||2.9|-1.9|
72583498|NCT03096314|144697999|SUPERIORITY||Mean Difference (Final Values)|0.0|||||TWO_SIDED|95.0|-0.2|0.1||||||||0.1|-0.2|
72583499|NCT03096314|144698000|SUPERIORITY||Risk Difference (RD)|0.4|||||TWO_SIDED|95.0|-4.4|5.1||||||||5.1|-4.4|
72583500|NCT03096314|144698001|SUPERIORITY||Mean Difference (Final Values)|-0.1|||||TWO_SIDED|95.0|-0.3|0.0||||||||0.0|-0.3|
72583501|NCT03096314|144698002|SUPERIORITY||Mean Difference (Final Values)|35.5|||||TWO_SIDED|95.0|31.5|39.6||||||||39.6|31.5|
72583502|NCT03096314|144698003|SUPERIORITY|||||||0.004|||||||t-test, 2 sided|||||||0.004
72583503|NCT03096314|144698004|SUPERIORITY|||||||0.67|||||||t-test, 2 sided|||||||0.67
72583504|NCT03096314|144698005|SUPERIORITY|||||||0.51|||||||Chi-squared|||||||0.51
72583505|NCT03096314|144698006|SUPERIORITY|||||||0.25|||||||Fisher Exact|||||||0.25
72583506|NCT03096314|144698007|SUPERIORITY|||||||0.69|||||||Chi-squared|||||||0.69
72583507|NCT03096314|144698008|SUPERIORITY|||||||0.24|||||||Chi-squared|||||||0.24
72583508|NCT00191477|144698125|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.946||||0.777||95.0|0.643|1.392||Only 87 recurrences and 7 deaths were documented at planned end of follow-up. The study was stopped early for futility reasons based on an interim analysis using pre-defined stopping boundaries for the hazard ratio (HR) of RFS.|Log Rank|||Sample-size calculation based on estimated 1-year recurrence-free survival (RFS) rates of 63% (gemcitabine) and 50% (placebo). 191 critical events were required to detect a difference in RFS (80% power, log-rank test, alpha=0.050). Sample size of 328 patients with clinical evidence of superficial bladder cancer needed to observe these 191 events within a 24-month follow-up period, assuming 246 of these patients would receive instillation and have histopathological diagnosis of pTa/pT1(G1-3/Gx).||1.392|0.643|0.777
72583509|NCT04760626|144698187|NON_INFERIORITY|Non-inferiority of insulin icodec was considered confirmed if the upper limit of the two-sided 95% confidence interval (CI) for mean treatment difference (insulin icodec with doseguide minus once daily basal insulin analogue) was strictly below 0.3 percent point.|Treatment difference|-0.38|||<|0.0001|TWO_SIDED|95.0|-0.66|-0.09|||ANCOVA|||The response and change from baseline in response after 52 weeks were analysed using an analysis of covariance (ANCOVA) model with region and randomised treatment as fixed factors, and baseline HbA1c as a covariate.||-0.09|-0.66|<0.0001
72583510|NCT03762265|144698196|SUPERIORITY||Difference in percentage|5.73|STANDARD_ERROR_OF_MEAN|7.535||0.4469|TWO_SIDED|95.0|-9.037|20.5|||Cochran-Mantel-Haenszel|||P-value and 95% confidence interval (CI) were based on Cochran-Mantel-Haenszel general association test stratified by disease type (PV or PF) and disease history (newly diagnosed \[\<=6 months prior to screening\] or relapsing \[diagnosed greater than \[\>\] 6 months prior to screening\]).||20.500|-9.037|0.4469
72583511|NCT03762265|144698197|SUPERIORITY||Difference in percentage|8.13|STANDARD_ERROR_OF_MEAN|7.085||0.251|TWO_SIDED|95.0|-5.752|22.019|||Cochran-Mantel-Haenszel|||P-value and 95% CI were based on Cochran-Mantel-Haenszel general association test stratified by disease type (PV or PF) and disease history (newly diagnosed \[\<=6 months prior to screening\] or relapsing \[diagnosed \>6 months prior to screening\]).||22.019|-5.752|0.2510
72583512|NCT01805089|144698239|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
72583513|NCT00806403|144698242|SUPERIORITY_OR_OTHER|||||||0.56||95.0|||||Fisher Exact|||Null hypothesis:there is no difference in ST resolution at 120 minutes after inclusion between thrombolysis and primary PCI. The power calculation was based on the aim to prove a 50% reduction of failure to achive at least a 50% ST resolution (40% failure in thrombolysis group and 20% failure in Primary PCI group). With a power of 80% and a significance level of 0.05 (2-sided test), a total of 166 patients would be required.||||0.56
72583514|NCT00806403|144698243|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|||||||1.00
72583515|NCT00806403|144698244|SUPERIORITY_OR_OTHER|||||||0.04|||||||Fisher Exact|||Null hypothesis:there is no difference in number of patients with TIMI 3 flow at 5-7 days after inclusion between thrombolysis and primary PCI. The power calculation was based on the aim to prove a 65% reduction of failure to achive TIMI 3 flow (30% failure in thrombolysis group and 10% failure in Primary PCI group). With a power of 90% and a significance level of 0.05 (2-sided test), a total of 180 patients would be required.||||0.04
72583516|NCT00806403|144698245|SUPERIORITY_OR_OTHER|||||||0.5||95.0|||||Fisher Exact|||||||0.50
72583517|NCT00806403|144698246|SUPERIORITY_OR_OTHER|||||||0.21||95.0|||||Fisher Exact|||||||0.21
72412962|NCT03198000|144334425|EQUIVALENCE|Prespecified equivalence interval of (0.80, 1.25).|Odds Ratio (OR)|0.87||||0.576|TWO_SIDED|95.0|0.539|1.411|||GEE model|GEE model with treatment as factor.||||1.411|0.539|0.576
72412963|NCT03198000|144334425|EQUIVALENCE|Prespecified equivalence interval of (0.80, 1.25)|Odds Ratio (OR)|0.87||||0.544|TWO_SIDED|95.0|0.552|1.368|||GEE model|GEE model with treatment as factor.||||1.368|0.552|0.544
72550746|NCT00366899|144631346|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC/GMT ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|0.65||||||95.0|0.51|0.83||||||For Polio Type 3 the GMC ratio (13vPnC/7vPnC) was calculated||0.83|0.51|
72550747|NCT00414466|144631353|SUPERIORITY_OR_OTHER|||||||0.802||95.0||||The a priori threshold for statistical significance was 0.05, two-sided.|Williams test for minimum effective dose|||Williams' test for Minimum Effective Dose was used to compare each active group to the placebo.||||0.802
72550748|NCT00414466|144631353|SUPERIORITY_OR_OTHER|||||||0.874||95.0||||The a priori threshold for statistical significance was 0.05, two-sided.|Williams test for minimum effective dose|||Williams' test for Minimum Effective Dose was used to compare each active group to the placebo.||||0.874
72583518|NCT02946463|144698251|NON_INFERIORITY|LDH-N was analyzed using a generalized estimating equation (GEE) approach. The model included the following terms: treatment group, history of transfusion (as a categorical variable based on the stratification factor levels), and baseline LDH level (as a continuous variable). Noninferiority margin was based on the lower bound of the 95% confidence interval (CI) for the odds ratio (OR) of ravulizumab versus eculizumab for LDH normalization being greater than an OR of 0.39.|Odds Ratio (OR)|1.187|||||TWO_SIDED|95.0|0.796|1.769||||||A minimum of 142 participants were estimated to provide 80% power to demonstrate noninferiority of ravulizumab to eculizumab.||1.769|0.796|
72583519|NCT02946463|144698252|NON_INFERIORITY|Noninferiority margin was based on the lower bound of the 95% CI. Noninferiority margin was -20%.|Treatment difference|6.8|||||TWO_SIDED|95.0|-4.66|18.14|||||Treatment difference was estimated for ravulizumab - eculizumab.|A minimum of 193 participants were estimated to provide 80% power to demonstrate noninferiority of ravulizumab to eculizumab. The difference of percentages were calculated using stratified Newcombe CI method. Stratification factors were: observed stratification groups of packed red blood cells (pRBC)/whole blood units transfused in the 1 year prior to first dose of study drug and screening LDH levels.||18.14|-4.66|
72583520|NCT02946463|144698253|NON_INFERIORITY|Noninferiority margin was based on the upper bound of the 95% CI. Noninferiority margin was 20%.|Treatment difference|-6.7|||||TWO_SIDED|95.0|-14.21|0.18|||||Treatment difference was estimated for ravulizumab - eculizumab.|The difference of percentages was calculated using stratified Newcombe CI method. The stratification factors were: observed stratification groups of pRBC units transfused in the 1 year prior to first dose of study drug and screening LDH levels.||0.18|-14.21|
72583521|NCT02946463|144698254|NON_INFERIORITY|Noninferiority margin was based on the upper bound of the 95% CI. Noninferiority margin was 20%.|Treatment difference|-0.83|||||TWO_SIDED|95.0|-5.21|3.56|||||Treatment difference was estimated for ravulizumab - eculizumab.|||3.56|-5.21|
72583522|NCT02946463|144698255|NON_INFERIORITY|Noninferiority margin was based on the lower bound of the 95% CI. Noninferiority margin was -5%.|Treatment difference|0.67|||||TWO_SIDED|95.0|-1.21|2.55|||||Treatment difference was estimated for ravulizumab - eculizumab.|||2.55|-1.21|
72550749|NCT00414466|144631353|SUPERIORITY_OR_OTHER|||||||0.899||95.0||||The a priori threshold for statistical significance was 0.05, two-sided.|Williams test for minimum effective dose|||Williams' test for Minimum Effective Dose was used to compare each active group to the placebo.||||0.899
72550750|NCT00414466|144631354|SUPERIORITY_OR_OTHER|||||||1||95.0||||The a priori threshold for statistical significance was 0.05, two-sided. Hochberg's adjustment for multiple comparisons was used.|Fisher Exact|||||||1.000
72550751|NCT00414466|144631354|SUPERIORITY_OR_OTHER|||||||1||95.0||||The a priori threshold for statistical significance was 0.05, two-sided. Hochberg's adjustment for multiple comparisons was used.|Fisher Exact|||||||1.000
72550752|NCT00414466|144631354|SUPERIORITY_OR_OTHER|||||||1||95.0||||The a priori threshold for statistical significance was 0.05, two-sided. Hochberg's adjustment for multiple comparisons was used.|Fisher Exact|||||||1.000
72550753|NCT00414466|144631355|SUPERIORITY_OR_OTHER|||||||0.083||95.0||||The a priori threshold for statistical significance was 0.05, two-sided. No adjustments for multiple comparisons were used.|Fisher Exact|||||||0.083
72550754|NCT00414466|144631355|SUPERIORITY_OR_OTHER|||||||1||95.0||||The a priori threshold for statistical significance was 0.05, two-sided. No adjustments for multiple comparisons were used.|Fisher Exact|||||||1.000
72550755|NCT00414466|144631355|SUPERIORITY_OR_OTHER|||||||0.352||95.0||||The a priori threshold for statistical significance was 0.05, two-sided. No adjustments for multiple comparisons were used.|Fisher Exact|||||||0.352
72550756|NCT00234078|144631392|SUPERIORITY_OR_OTHER|||||||0.385||||||versus placebo|t-test, 2 sided|a general linear model||||||0.385
72550757|NCT00234078|144631393|SUPERIORITY_OR_OTHER|||||||0.601||||||versus placebo|t-test, 2 sided|a general linear model||||||0.601
72550758|NCT00234078|144631394|SUPERIORITY_OR_OTHER|||||||0.084||||||p-value is adjusted for multiple comparisons|t-test, 2 sided|||||||0.084
72550759|NCT00234078|144631394|SUPERIORITY_OR_OTHER|||||||0.02||||||p-value is adjusted for multiple comparisons|t-test, 2 sided|||||||0.020
72550760|NCT00234078|144631394|SUPERIORITY_OR_OTHER|||||||0.421||||||p-value is adjusted for multiple comparisons|t-test, 2 sided|||||||0.421
72550761|NCT00234078|144631395|SUPERIORITY_OR_OTHER|||||||0.087||||||p-value is adjusted for multiple comparisons|t-test, 2 sided|||||||0.087
72550762|NCT00234078|144631395|SUPERIORITY_OR_OTHER|||||||0.004||||||p-value is adjusted for multiple comparisons|t-test, 2 sided|||||||0.004
72550763|NCT00234078|144631395|SUPERIORITY_OR_OTHER|||||||0.029||||||p-value is adjusted for multiple comparisons|t-test, 2 sided|||||||0.029
72550764|NCT05628675|144631412|OTHER||Effect size (Hedge's g)|0.32|||||TWO_SIDED|95.0|-0.33|0.96||||||Effect size calculation from Time 1 to Time 2 on MAAS||0.96|-0.33|
72583523|NCT02946463|144698256|NON_INFERIORITY|Noninferiority margin was based on the lower bound of the 95% CI. Noninferiority margin was -20%.|Treatment difference|2.9|||||TWO_SIDED|95.0|-8.8|14.64|||||Treatment difference was estimated for ravulizumab - eculizumab.|The difference of percentages was calculated using stratified Newcombe CI method. The stratification factors were: observed stratification groups of pRBC units transfused in the 1 year prior to first dose of study drug and screening LDH levels.||14.64|-8.80|
72550765|NCT05628675|144631412|OTHER||Effect size (Hedge's g)|0.72|||||TWO_SIDED|95.0|0.02|1.42||||||Effect size calculation from Time 1 to Time 3 on MAAS||1.42|0.02|
72550766|NCT05628675|144631413|OTHER||Effect size (Hedge's g)|0.36|||||TWO_SIDED|95.0|-0.29|1.01||||||Effect size calculation from Time 1 to Time 2 on P-PRFQ||1.01|-0.29|
72550767|NCT05628675|144631413|OTHER||Effect size (Hedge's g)|0.49|||||TWO_SIDED|95.0|-0.2|1.17||||||Effect size calculation from Time 1 to Time 3 on P-PRFQ||1.17|-0.20|
72550768|NCT05628675|144631414|OTHER||Effect size (Hedge's g)|1.48|||||TWO_SIDED|95.0|0.75|2.21||||||Effect size calculation from Time 1 to Time 2 on EPDS||2.21|0.75|
72550769|NCT05628675|144631414|OTHER||Effect size (Hedge's g)|2.08|||||TWO_SIDED|95.0|1.28|2.88||||||Effect size calculation from Time 1 to Time 3 on EPDS||2.88|1.28|
72550770|NCT01475838|144631431|NON_INFERIORITY_OR_EQUIVALENCE|The null hypothesis was that the Stribild group was at least 12% worse than the PI+RTV+FTC/TDF group with respect to the percentage of participants maintaining HIV-1 RNA \< 50 copies/mL at Week 48. The alternative hypothesis was that the Stribild group was less than 12% worse than the PI+RTV+FTC/TDF group.|Difference in proportions|6.7||||0.025|TWO_SIDED|95.0|0.4|13.7|||Fisher Exact||The 95% confidence interval (CI) for the difference was from unconditional exact method using 2 inverted 1-sided tests with the standardized statistic using StatXact.|||13.7|0.4|0.025
72550771|NCT00048568|144631435|SUPERIORITY_OR_OTHER||Estimated Difference|28.2|||<|0.001|TWO_SIDED|95.0|19.8|36.7|||Chi-squared, Corrected||Estimated difference between ABA + MTX and MTX + PLA is the estimated difference between ABA+MTX and MTX + PLA in the proportion of participants achieving ACR 20 response.|The study had a 99% power to detect a difference of 20% in ACR 20 between the 2 groups at the 5% level.||36.7|19.8|<0.001
72550772|NCT00048568|144631436|SUPERIORITY_OR_OTHER||Estimated Difference|24.4|||<|0.001|TWO_SIDED|95.0|15.9|32.9||Based on the hierarchical testing procedure for the co-primary measures, the study had 98% power to detect 18% difference in HAQ response rate between the two arms at the 5% level.|Chi-squared, Corrected|This model includes treatment as the main factor and baseline value as a covariate.|Estimated difference between ABA + MTX and MTX + PLA is the estimated difference between ABA+MTX and MTX + PLA in the proportion of participants achieving HAQ response at Day 365.|||32.9|15.9|<0.001
72550773|NCT00048568|144631437|SUPERIORITY_OR_OTHER|||||||0.029||95.0|||||Nonparametric ANCOVA|The rank of the change from baseline=dependent variable, treatment=the main factor, rank of baseline value as covariate.||||||0.029
72550774|NCT00048568|144631441|SUPERIORITY_OR_OTHER||Estimated Difference|33.4|||<|0.001|TWO_SIDED|95.0|25.1|41.7|||Chi-squared, Corrected||Estimated difference between ABA + MTX and MTX + PLA is the estimated difference between ABA+MTX and MTX + PLA in the proportion of participants achieving ACR 20 response at Day 365.|||41.7|25.1|<0.001
72550775|NCT00048568|144631443|SUPERIORITY_OR_OTHER||Estimated Difference|23.0|||<|0.001|TWO_SIDED|95.0|15.0|31.1|||Chi-squared, Corrected||Estimated difference between ABA + MTX and MTX + PLA is the estimated difference between ABA+MTX and MTX + PLA in the proportion of participants achieving ACR 50 response at Day 169.|||31.1|15.0|<0.001
72550776|NCT00048568|144631444|SUPERIORITY_OR_OTHER||Estimated Difference|30.1|||<|0.001|TWO_SIDED|95.0|21.8|38.5|||Chi-squared, Corrected||Estimated difference between ABA + MTX and MTX + PLA is the estimated difference between ABA+MTX and MTX + PLA in the proportion of participants achieving ACR 50 response at Day 365.|||38.5|21.8|<0.001
72412964|NCT03198000|144334426|EQUIVALENCE|No equivalence interval was specified for this time point.|Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.04||0.893|TWO_SIDED|95.0|-0.085|0.074|||ANCOVA|Mixed effect ANCOVA with treatment as factor and baseline value as a covariate.||||0.074|-0.085|0.893
72412965|NCT03198000|144334426|EQUIVALENCE|No equivalence interval was specified for this time point.|Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.04||0.886|TWO_SIDED|95.0|-0.073|0.084|||ANCOVA|Mixed effect ANCOVA with treatment as factor and baseline value as a covariate.||||0.084|-0.073|0.886
72412966|NCT03198000|144334427|EQUIVALENCE|No equivalence interval was specified for this time point.|Mean Difference (Final Values)|-0.08|STANDARD_ERROR_OF_MEAN|0.05||0.117|TWO_SIDED|95.0|-0.177|0.02|||ANCOVA|Mixed effect ANCOVA with treatment as factor and baseline value as a covariate.||||0.020|-0.177|0.117
72412967|NCT03198000|144334427|EQUIVALENCE|No equivalence interval was specified for this time point.|Mean Difference (Final Values)|-0.06|STANDARD_ERROR_OF_MEAN|0.049||0.255|TWO_SIDED|95.0|-0.153|0.041|||ANCOVA|Mixed effect ANCOVA with treatment as factor and baseline value as a covariate.||||0.041|-0.153|0.255
72412968|NCT03198000|144334429|EQUIVALENCE|No equivalence interval was specified.|Mean Difference (Final Values)|0.4|STANDARD_ERROR_OF_MEAN|0.21||0.085|TWO_SIDED|95.0|-0.05|0.78|||ANCOVA|Mixed effect ANCOVA with treatment as factor and baseline value as a covariate.||||0.78|-0.05|0.085
72412969|NCT03198000|144334429|EQUIVALENCE|No equivalence interval was specified for this time point.|Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|0.21||0.269|TWO_SIDED|95.0|-0.18|0.64|||ANCOVA|Mixed effect ANCOVA with treatment as factor and baseline value as a covariate.||||0.64|-0.18|0.269
72583524|NCT01383174|144698257|SUPERIORITY_OR_OTHER|||||||0.015|TWO_SIDED|||||P-value represents the significance of the time by treatment group interaction from the repeated-measures linear regression model. For consistency with the manuscript, we report here the absolute means and standard deviations.|Mixed Models Analysis|||||||0.015
72583525|NCT01383174|144698258|SUPERIORITY_OR_OTHER|||||||0.465|TWO_SIDED|||||P-value represents the significance of the time by treatment group interaction from the repeated-measures linear regression model. For consistency with the manuscript, we report here the absolute means and standard deviations.|Mixed Models Analysis|||||||.465
72583526|NCT01383174|144698259|SUPERIORITY_OR_OTHER|||||||0.025|TWO_SIDED|||||P-value represents the significance of the time by treatment group interaction from the repeated-measures linear regression model. For consistency with the manuscript, we report here the absolute means and standard deviations.|Mixed Models Analysis|||||||.025
72583527|NCT01383174|144698260|SUPERIORITY_OR_OTHER|||||||0.004|TWO_SIDED|||||P-value represents the significance of the time by treatment group interaction from the repeated-measures linear regression model. For consistency with the manuscript, we report here the absolute means and standard deviations.|Mixed Models Analysis|||||||.004
72583528|NCT01383174|144698261|SUPERIORITY_OR_OTHER|||||||0.013|TWO_SIDED|||||P-value represents the significance of the time by treatment group interaction from the repeated-measures linear regression model. For consistency with the manuscript, we report here the absolute means and standard deviations.|Mixed Models Analysis|||||||.013
72583529|NCT01383174|144698262|SUPERIORITY_OR_OTHER|||||||0.267|TWO_SIDED|||||P-value represents the significance of the time by treatment group interaction from the repeated-measures linear regression model. For consistency with the manuscript, we report here the absolute means and standard deviations.|Mixed Models Analysis|||||||.267
72583530|NCT01383174|144698263|SUPERIORITY_OR_OTHER|||||||0.03|TWO_SIDED|||||P-value represents the significance of the time by treatment group interaction from the repeated-measures linear regression model. For consistency with the manuscript, we report here the absolute means and standard deviations.|Mixed Models Analysis|||||||.030
72583531|NCT01383174|144698264|SUPERIORITY_OR_OTHER|||||||0.045|TWO_SIDED|||||P-value represents the significance of the time by treatment group interaction from the repeated-measures linear regression model. For consistency with the manuscript, we report here the absolute means and standard deviations.|Mixed Models Analysis|||||||.045
72583532|NCT01383174|144698265|SUPERIORITY_OR_OTHER|||||||0.005|TWO_SIDED|||||P-value represents the significance of the time by treatment group interaction from the repeated-measures linear regression model. For consistency with the manuscript, we report here the absolute means and standard deviations.|Mixed Models Analysis|||||||.005
72583533|NCT01383174|144698266|SUPERIORITY_OR_OTHER|||||||0.226|TWO_SIDED|||||P-value represents the significance of the time by treatment group interaction from the repeated-measures linear regression model. For consistency with the manuscript, we report here the absolute means and standard deviations.|Mixed Models Analysis|||||||.226
72583534|NCT01787292|144698267|SUPERIORITY|||||||0.001||||||To account for sequence carryover, we employed analysis of covariance inclusive of sequence by period covariates against treatment effects.|ANCOVA|Least square means were adjusted for carryover from the crossover design and between subjects effects were analyzed using Kenward-Roger df estimation||||||.001
72583535|NCT01787292|144698268|SUPERIORITY|||||||0.8|||||||ANCOVA|||To account for sequence carryover, we employed analysis of covariance inclusive of sequence by period covariates against treatment effects.||||.8
72583536|NCT01787292|144698269|SUPERIORITY|||||||0.05||||||To account for sequence carryover, we employed analysis of covariance inclusive of sequence by period covariates against treatment effects.|ANCOVA|||||||.05
72583537|NCT01787292|144698270|SUPERIORITY|||||||0.05||||||To account for sequence carryover, we employed analysis of covariance inclusive of sequence by period covariates against treatment effects.|ANCOVA|A Kenward-Rogers adjustment for degrees of freedom was made to account for carryover effects.||||||.05
72583538|NCT01787292|144698271|SUPERIORITY|||||||0.01|||||||t-test, 2 sided|||||||.01
72583539|NCT01787292|144698272|SUPERIORITY|||||||0.01|||||||t-test, 2 sided|||||||.01
72583540|NCT01787292|144698273|SUPERIORITY|||||||0.01|||||||t-test, 2 sided|||||||.01
72583541|NCT01787292|144698274|SUPERIORITY|||||||0.5|||||||t-test, 2 sided|||||||.5
72583542|NCT01787292|144698275|SUPERIORITY|||||||0.6|||||||t-test, 2 sided|A Kenward-Rogers adjustment for df was made to account for carryover effects.||||||.6
72583543|NCT01787292|144698276|SUPERIORITY|||||||0.4|||||||t-test, 2 sided|||||||.4
72583544|NCT01787292|144698277|SUPERIORITY|||||||0.05|||||||t-test, 2 sided|||||||.05
72583545|NCT01787292|144698278|SUPERIORITY|||||||0.25|||||||t-test, 2 sided|||||||.25
72583546|NCT01787292|144698279|SUPERIORITY|||||||0.01|||||||t-test, 2 sided|||||||.01
72550777|NCT00048568|144631446|SUPERIORITY_OR_OTHER||Estimated Difference|13.3|||<|0.001|TWO_SIDED|95.0|7.0|19.5|||Chi-squared, Corrected||Estimated difference between ABA + MTX and MTX + PLA is the estimated difference between ABA + MTX and MTX + PLA in the proportion of participants achieving ACR 70 response at Day 169.|||19.5|7.0|<0.001
72550778|NCT00048568|144631447|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|22.7|||<|0.001|TWO_SIDED|95.0|15.6|29.8|||Chi-squared, Corrected|||||29.8|15.6|<0.001
72550779|NCT00048568|144631449|SUPERIORITY_OR_OTHER||Estimated Difference|12.3|||<|0.001|TWO_SIDED|95.0|7.3|17.2|||Chi-squared, Corrected||Estimated difference between ABA + MTX and MTX + PLA is the estimated difference between ABA+MTX and MTX + PLA in the proportion of participants achieving MCR.|||17.2|7.3|<0.001
72583547|NCT05691712|144698296|SUPERIORITY||LS Mean Difference|-16.1|||<|0.001|TWO_SIDED|95.0|-19.9|-12.36|||Mixed Models Analysis|||||-12.36|-19.9|<0.001
72583548|NCT05691712|144698296|SUPERIORITY||LS Mean Difference|-15.9|||<|0.001|TWO_SIDED|95.0|-19.7|-12.1|||Mixed Models Analysis|||||-12.10|-19.7|<0.001
72583549|NCT05691712|144698297|SUPERIORITY||LS Mean Difference|-13.06|||<|0.001|TWO_SIDED|95.0|-16.8|-9.34|||Mixed Models Analysis|||||-9.34|-16.8|<0.001
72583550|NCT05691712|144698298|SUPERIORITY||LS Mean Difference|-4.4|||<|0.001|TWO_SIDED|95.0|-5.8|-2.9|||Mixed Models Analysis|||||-2.9|-5.8|<0.001
72583551|NCT05691712|144698298|SUPERIORITY||LS Mean Difference|-6.5|||<|0.001|TWO_SIDED|95.0|-8.0|-5.0|||Mixed Models Analysis|||||-5.0|-8.0|<0.001
72583552|NCT05691712|144698298|SUPERIORITY||LS Mean Difference|-6.0|||<|0.001|TWO_SIDED|95.0|-7.5|-4.5|||Mixed Models Analysis|||||-4.5|-7.5|<0.001
72583553|NCT05691712|144698300|SUPERIORITY||LS Mean Difference|-21.9|||<|0.001|TWO_SIDED|95.0|-32.4|-11.3|||Mixed Models Analysis|||||-11.3|-32.4|<0.001
72583554|NCT05691712|144698300|SUPERIORITY||LS Mean Difference|-28.9|||<|0.001|TWO_SIDED|95.0|-39.6|-18.1|||Mixed Models Analysis|||||-18.1|-39.6|<0.001
72550780|NCT00048568|144631450|SUPERIORITY_OR_OTHER||Estimated Difference on Day 169|-1.15|||<|0.001|TWO_SIDED|95.0|-1.38|-0.91|||ANCOVA||Estimated difference between ABA + MTX and MTX + PLA on Day 169.|||-0.91|-1.38|<0.001
72550781|NCT00048568|144631450|SUPERIORITY_OR_OTHER||Estimated Difference on Day 365|-1.39|||<|0.001|TWO_SIDED|95.0|-1.63|-1.16|||ANCOVA||Estimated difference between ABA + MTX and MTX + PLA on Day 365.|||-1.16|-1.63|<0.001
72550782|NCT00048568|144631454|SUPERIORITY_OR_OTHER||Adjusted Mean Difference at Day 169|4.06|||<|0.001|TWO_SIDED|95.0|2.64|5.57|||ANCOVA|||Adjustment based on ANCOVA model with treatment as factor and baseline value as covariate.||5.57|2.64|<0.001
72583555|NCT05691712|144698300|SUPERIORITY||LS Mean Difference|-27.3|||<|0.001|TWO_SIDED|95.0|-38.2|-16.5|||Mixed Models Analysis|||||-16.5|-38.2|<0.001
72583556|NCT02996227|144698316|NON_INFERIORITY|The noninferiority was defined as no more than 25% greater opioid consumption and no worse than 1-point higher pain score at rest. Non-inferiority of TAP with liposomal bupivacaine to epidural could be claimed if the upper limit of the 95.2% CI for the mean difference of pain scores at rest was less than 1 point and the CI for the ratio of geometric means in opioid consumption was less than 1.25.|Mean Difference (Final Values)|0.09|||<|0.001|TWO_SIDED|95.2|-0.12|0.3|||Mixed Models Analysis|||||0.30|-0.12|<0.001
72583557|NCT02996227|144698317|NON_INFERIORITY|The noninferiority was defined as no more than 25% greater opioid consumption and no worse than 1-point higher pain score at rest. Non-inferiority of TAP with liposomal bupivacaine to epidural could be claimed if the upper limit of the 95.2% CI for the mean difference of pain scores at rest was less than 1 point and the CI for the ratio of geometric means in opioid consumption was less than 1.25.|Ratio of Geometric means|1.37||||0.754|TWO_SIDED|95.2|1.05|1.79|||Mixed Models Analysis|||||1.79|1.05|0.754
72583558|NCT02996227|144698318|SUPERIORITY||Mean Difference (Final Values)|1.2||||0.56|TWO_SIDED|99.0|0.53|2.76|||Regression, Linear|linear regression after logarithm transformation||||2.76|0.53|0.560
72583559|NCT02996227|144698319|SUPERIORITY||Mean Difference (Final Values)|0.36||||0.357|TWO_SIDED|99.0|-0.65|1.37|||Regression, Linear||Difference in means between two groups was assessed using mixed effects model with repeated measurements with unstructured correlation structure|||1.37|-0.65|0.357
72583560|NCT02996227|144698320|SUPERIORITY||Risk Ratio (RR)|0.64||||0.006|TWO_SIDED|99.0|0.42|0.98|||generalized linear regression|||||0.98|0.42|0.006
72583561|NCT02996227|144698321|SUPERIORITY||Mean Difference (Final Values)|0.77||||0.695|TWO_SIDED|99.0|-4.31|5.85|||Regression, Linear||Difference in means between two groups was assessed using mixed effects model with repeated measurements with unstructured correlation structure.|||5.85|-4.31|0.695
72583562|NCT02996227|144698322|SUPERIORITY||Ratio of geometric means|0.98||||0.738|TWO_SIDED|99.0|0.86|1.12|||Regression, Linear|linear regression after logarithmic transformation||||1.12|0.86|0.738
72583563|NCT03349060|144698355|SUPERIORITY||Difference in Percentage|15.8||||0.0037|TWO_SIDED|95.0|6.8|24.8||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||The estimate and confidence interval (CI) for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||24.8|6.8|0.0037
72583564|NCT03349060|144698355|SUPERIORITY||Difference in Percentage|36.0|||<|0.0001|TWO_SIDED|95.0|26.2|45.7||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||45.7|26.2|<0.0001
72583565|NCT03349060|144698356|SUPERIORITY||Difference in Percentage|27.9|||<|0.0001|TWO_SIDED|95.0|17.4|38.3||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||38.3|17.4|<0.0001
72583566|NCT03349060|144698356|SUPERIORITY||Difference in Percentage|51.0|||<|0.0001|TWO_SIDED|95.0|40.5|61.5|||Cochran-Mantel-Haenszel|||The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||61.5|40.5|<0.0001
72412970|NCT03198000|144334430|EQUIVALENCE|No equivalence interval was specified.|Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.18||0.162|TWO_SIDED|95.0|-0.6|0.1|||ANCOVA|Mixed effect ANCOVA with treatment as factor and baseline value as a covariate.||||0.10|-0.60|0.162
72412971|NCT03198000|144334430|EQUIVALENCE|No equivalence interval was specified for this time point.|Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.17||0.234|TWO_SIDED|95.0|-0.55|0.14|||ANCOVA|Mixed effect ANCOVA with treatment as factor and baseline value as a covariate.||||0.14|-0.55|0.234
72550783|NCT00048568|144631454|SUPERIORITY_OR_OTHER||Adjusted Mean Difference at Day 365|4.15|||<|0.001|TWO_SIDED|95.0|2.69|5.62|||ANCOVA|||Adjustment based on ANCOVA model with treatment as factor and baseline value as covariate.||5.62|2.69|<0.001
72550784|NCT00048568|144631455|SUPERIORITY_OR_OTHER||Estimated Difference|5.7||||0.002|TWO_SIDED|95.0|2.4|9.0|||Chi-squared, Corrected||Estimated difference between ABA + MTX and MTX + PLA is the estimated difference between ABA+MTX and MTX + PLA in the proportion of participants achieving extended MCR.|||9.0|2.4|0.002
72550785|NCT03831048|144631581|NON_INFERIORITY|The primary analysis of this endpoint will be performed using a linear probability model, with the following terms in the model: (1) treatment; and (2) the known donor and recipient risk factors listed above. Variables that make the model fail to converge will be dropped from the model. The test will be conducted at the one-sided 0.05 level of significance.|Mean Difference (Final Values)|-0.032|||<|0.0001|TWO_SIDED|90.0|-0.098|0.034||No multiple comparison adjustment.|Regression, Linear|||"The null and alternative hypotheses for the primary endpoint are as follows:~H0: pSOC - pDCD ≥ 0.20 vs. H1: pSOC - pDCD \< 0.20 where pDCD and pSOC represent the true survival proportions at the six months follow-up visit for DCD and SOC heart transplant patients, respectively."||0.034|-0.098|<0.0001
72583567|NCT03349060|144698357|SUPERIORITY||Difference in Percentage|18.0||||0.0004|TWO_SIDED|95.0|10.2|25.8|||Cochran-Mantel-Haenszel|||Week 2: Each complete imputed data set was analyzed using the Cochran-Mantel-Haenszel (CMH) risk difference method adjusting by randomization strata, separately for each week. Results from multiply imputed data sets were combined using Rubin's rules to obtain treatment difference, 95% CI and p-value.||25.8|10.2|0.0004
72583568|NCT03349060|144698357|SUPERIORITY||Difference in Percentage|42.5|||<|0.0001|TWO_SIDED|95.0|33.6|51.4|||Cochran-Mantel-Haenszel|||Week 2: Each complete imputed data set was analyzed using the CMH risk difference method adjusting by randomization strata, separately for each week. Results from multiply imputed data sets were combined using Rubin's rules to obtain treatment difference, 95% CI and p-value.||51.4|33.6|<0.0001
72583569|NCT03349060|144698357|SUPERIORITY||Difference in Percentage|15.0||||0.0251|TWO_SIDED|95.0|1.9|28.0|||Cochran-Mantel-Haenszel|||Week 4: Each complete imputed data set was analyzed using the CMH risk difference method adjusting by randomization strata, separately for each week. Results from multiply imputed data sets were combined using Rubin's rules to obtain treatment difference, 95% CI and p-value.||28.0|1.9|0.0251
72583570|NCT03349060|144698357|SUPERIORITY||Difference in Percentage|41.1|||<|0.0001|TWO_SIDED|95.0|27.8|54.4|||Cochran-Mantel-Haenszel|||Week 4: Each complete imputed data set was analyzed using the CMH risk difference method adjusting by randomization strata, separately for each week. Results from multiply imputed data sets were combined using Rubin's rules to obtain treatment difference, 95% CI and p-value.||54.4|27.8|<0.0001
72583571|NCT03349060|144698357|SUPERIORITY||Difference in Percentage|20.0||||0.0019|TWO_SIDED|95.0|7.4|32.7|||Cochran-Mantel-Haenszel|||Week 8: Each complete imputed data set was analyzed using the CMH risk difference method adjusting by randomization strata, separately for each week. Results from multiply imputed data sets were combined using Rubin's rules to obtain treatment difference, 95% CI and p-value.||32.7|7.4|0.0019
72583572|NCT03349060|144698357|SUPERIORITY||Difference in Percentage|45.3|||<|0.0001|TWO_SIDED|95.0|32.7|57.8|||Cochran-Mantel-Haenszel|||Week 8: Each complete imputed data set was analyzed using the CMH risk difference method adjusting by randomization strata, separately for each week. Results from multiply imputed data sets were combined using Rubin's rules to obtain treatment difference, 95% CI and p-value.||57.8|32.7|<0.0001
72583573|NCT03349060|144698357|SUPERIORITY||Difference in Percentage|22.5||||0.0003|TWO_SIDED|95.0|10.3|34.8|||Cochran-Mantel-Haenszel|||Week 12: Each complete imputed data set was analyzed using the CMH risk difference method adjusting by randomization strata, separately for each week. Results from multiply imputed data sets were combined using Rubin's rules to obtain treatment difference, 95% CI and p-value.||34.8|10.3|0.0003
72412972|NCT03198000|144334431|EQUIVALENCE|No equivalence interval was specified.|Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.17||0.398|TWO_SIDED|95.0|-0.48|0.19|||ANCOVA|Mixed effect ANCOVA with treatment as factor and baseline value as a covariate.||||0.19|-0.48|0.398
72412973|NCT03198000|144334431|EQUIVALENCE|No equivalence interval was specified for this time point.|Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.17||0.233|TWO_SIDED|95.0|-0.54|0.13|||ANCOVA|Mixed effect ANCOVA with treatment as factor and baseline value as a covariate.||||0.13|-0.54|0.233
72412974|NCT03965052|144334475|OTHER|||||||1|||||||Fisher Exact|||||||1.000
72412975|NCT03965052|144334477|OTHER|||||||1|||||||Fisher Exact|||Lissamine green treatment groups||||1.000
72412976|NCT03965052|144334477|OTHER|||||||0.667|||||||Fisher Exact|||Fluorescein treatment groups||||0.667
72583574|NCT03349060|144698357|SUPERIORITY||Difference in Percentage|41.7|||<|0.0001|TWO_SIDED|95.0|29.6|53.9|||Cochran-Mantel-Haenszel|||Week 12: Each complete imputed data set was analyzed using the CMH risk difference method adjusting by randomization strata, separately for each week. Results from multiply imputed data sets were combined using Rubin's rules to obtain treatment difference, 95% CI and p-value.||53.9|29.6|<0.0001
72583575|NCT03349060|144698358|SUPERIORITY||Difference in Percentage|16.3||||0.0055|TWO_SIDED|95.0|7.4|25.2|||Cochran-Mantel-Haenszel|||Week 2: Each complete imputed data set was analyzed using the CMH risk difference method adjusting by randomization strata, separately for each week. Results from multiply imputed data sets were combined using Rubin's rules to obtain treatment difference, 95% CI and p-value.||25.2|7.4|0.0055
72550786|NCT03831048|144631582|OTHER|No hypothesis test.||||||||||||||||No null hypothesis test.|No statistical hypothesis testing. This endpoint will be summarized for the OCS Heart Population using counts and percentages and an exact (Clopper-Pearson) 95% confidence interval for the true percentage based on the binomial distribution. It will also be summarized for the modified OCS Heart Population, defined as the number of DCD hearts that were successfully transplanted after preservation and assessment on the OCS divided by the total number of DCD donor hearts that were instrumented on the OCS.|||
72550787|NCT00849901|144631628|SUPERIORITY_OR_OTHER|||||||0.999||95.0|||||Mixed Models Analysis|||||||0.999
72550788|NCT00262223|144631640|SUPERIORITY_OR_OTHER_LEGACY||Incidence Rate Ratio|1.6||||0.34|TWO_SIDED|95.0|0.61|4.23|||Generalized Estimating Equations|Negative binomial models with log link were applied to the alcohol consumption measure.||Between group analyses were conducted of time-by-treatment interaction that included the four study time points (baseline, end-of-treatment, 6-mos and 12-mos).||4.23|0.61|0.34
72552763|NCT00377260|144636500|SUPERIORITY_OR_OTHER|||||||0.66||95.0|||||Generalized estimating equations|The comparison was adjusted for site, history of recurrent acute otitis media and exposure to other children.||Null hypothesis: There is no difference between the two groups regarding the visits at which family member reported making special daycare arrangements, i.e. number of such visits / total number of follow-up assessment visits.||||.66
72552764|NCT00377260|144636501|SUPERIORITY_OR_OTHER|||||||0.71||95.0|||||Regression, Linear|The comparison adjusted for site, history of recurrent acute otitis media and exposure to other children.||Null hypothesis: There is no difference between the groups regarding the mean parental satisfaction score at the on-therapy visit.||||.71
72552765|NCT00377260|144636502|SUPERIORITY_OR_OTHER|||||||0.04||95.0|||||Regression, Linear|The comparison adjusted for site, history of recurrent acute otitis media and exposure to other children.||Null hypothesis: There is no difference between the groups regarding the mean parental satisfaction score at the end-of-therapy visit.||||.04
72552766|NCT00377260|144636503|SUPERIORITY_OR_OTHER|||||||0.005||95.0|||||Regression, Linear|The comparison adjusted for site, history of recurrent acute otitis media and exposure to other children.||Null hypothesis: There is no difference between the groups regarding the mean parental satisfaction score at the follow-visit visit.||||.005
72552767|NCT00377260|144636504|SUPERIORITY_OR_OTHER|||||||0.01||95.0|||||Regression, Linear|The comparison was adjusted for site, history of recurrent acute otitis media and exposure to other children.||Null hypothesis: There is no difference between the two treatment groups regarding the mean weighted average acute otitis media - severity of symptom (AOM-SOS) score (symptom burden), post-enrollment, over the first 7 days of therapy.||||.01
72552768|NCT00829530|144636505|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|88.87||||||90.0|80.31|98.34|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||98.34|80.31|
72552769|NCT00829530|144636506|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|94.96||||||90.0|89.77|100.45|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||100.45|89.77|
72552770|NCT00829530|144636507|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|95.24||||||90.0|90.13|100.63|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||100.63|90.13|
72552771|NCT00829530|144636508|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|98.85||||||90.0|91.95|106.27|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||106.27|91.95|
72552772|NCT00829530|144636509|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|100.62||||||90.0|97.8|103.52|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||103.52|97.8|
72552773|NCT00840866|144636510|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model containing factors for sequence of products, subjects within sequence, periods, and products was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|104.0||||||90.0|99.0|109.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||109|99|
72552774|NCT00840866|144636511|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model containing factors for sequence of products, subjects within sequence, periods, and products was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|99.9||||||90.0|98.6|101.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||101|98.6|
72552775|NCT00840866|144636512|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model containing factors for sequence of products, subjects within sequence, periods, and products was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|99.8||||||90.0|98.5|101.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||101|98.5|
72552776|NCT04112823|144636513|SUPERIORITY||Risk Ratio (RR)|7.0|||||TWO_SIDED|95.0|-6.0|20.0||||||||20|-6|
72412977|NCT03965052|144334478|OTHER|||||||1|||||||Wilcoxon (Mann-Whitney)|||||||1.000
72412978|NCT03965052|144334479|OTHER|||||||0.977|||||||Chi-squared, Corrected|||the analysis was per protocol||||0.977
72412979|NCT03965052|144334481|OTHER|||||||0.019|||||||Wilcoxon (Mann-Whitney)|||||||0.019
72412980|NCT00358735|144334490|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Chi-squared|||||||>0.05
72412981|NCT00358735|144334491|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Chi-squared|||||||>0.05
72412982|NCT00358735|144334492|SUPERIORITY_OR_OTHER|||||||0.0004|||||||Chi-squared|||||||0.0004
72412983|NCT00358735|144334494|SUPERIORITY_OR_OTHER|||||||0.953|||||||Chi-squared|||||||0.953
72412984|NCT00358735|144334495|SUPERIORITY_OR_OTHER|||||||0.05|||||||Chi-squared|||||||0.050
72412985|NCT00358735|144334496|SUPERIORITY_OR_OTHER|||||||0.01|||||||Chi-squared|||||||0.010
72412986|NCT00358735|144334497|SUPERIORITY_OR_OTHER|||||||0.507|||||||Chi-squared|||||||0.507
72412987|NCT00358735|144334498|SUPERIORITY_OR_OTHER|||||||0.052|||||||Chi-squared|||||||0.052
72412988|NCT00358735|144334499|SUPERIORITY_OR_OTHER|||||||0.798|||||||Chi-squared|||||||0.798
72412989|NCT00358735|144334500|SUPERIORITY_OR_OTHER|||||||0.036|||||||Chi-squared|||||||0.036
72552777|NCT04112823|144636514|SUPERIORITY||Risk Ratio (RR)|4.0|||||TWO_SIDED|95.0|-8.0|16.0||||||||16|-8|
72552778|NCT04112823|144636515|SUPERIORITY||Risk Ratio (RR)|3.0|||||TWO_SIDED|95.0|-8.0|14.0||||||||14|-8|
72552779|NCT04112823|144636517|SUPERIORITY||Mean Difference (Net)|0.4|||||TWO_SIDED|95.0|-0.3|1.2||||||||1.2|-0.3|
72552780|NCT04112823|144636518|SUPERIORITY||Risk Ratio (RR)|4.0|||||TWO_SIDED|95.0|-9.0|18.0||||||||18|-9|
72552781|NCT02924883|144636529|SUPERIORITY||Hazard Ratio (HR)|0.82||||0.3332||95.0|0.55|1.23|||Log Rank|The 2-sided log-rank test, was stratified by world region (Western Europe vs U.S. vs Rest of World) and PD-L1 status (IC 0 vs IC 1/2/3).||||1.23|0.55|0.3332
72552782|NCT02924883|144636531|SUPERIORITY||Hazard Ratio (HR)|0.74||||0.2934||95.0|0.42|1.3|||Log Rank|The 2-sided log-rank test was stratified by world region (Western Europe vs U.S. vs Rest of World) and PD-L1 status (IC 0 vs IC 1/2/3).||||1.30|0.42|0.2934
72552783|NCT02924883|144636533|SUPERIORITY||Hazard Ratio (HR)|1.26||||0.6099||95.0|0.52|3.03|||Log Rank|Stratified Cox proportional hazards model was stratified by world region (Western Europe, U.S., Rest of World) and PD-L1 status (IC 0, IC 1/2/3).||||3.03|0.52|0.6099
72552784|NCT00772941|144636552|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Chi-squared|||"The risk factor tested was Gender. The null hypothesis is that there is no difference between Male and Female in the frequency of Treatment Related Adverse Events."||||<0.001
72552785|NCT00772941|144636553|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Chi-squared|||"The risk factor tested was Age. The null hypothesis is that there is no difference between \<65 years and \>=65 years in the frequency of Treatment Related Adverse Events."||||<0.001
72552786|NCT00772941|144636554|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Chi-squared|||"The risk factor tested was Chronic obstructive pulmonary disease as a complication. The null hypothesis is that there is no difference between Varenicline with and without Chronic obstructive pulmonary disease as a complication in the frequency of Treatment Related Adverse Events."||||<0.001
72552787|NCT00772941|144636555|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Chi-squared|||"The risk factor tested was concomitant drugs. The null hypothesis is that there is no difference between Varenicline with and without concomitant drugs in the frequency of Treatment Related Adverse Events."||||<0.001
72552788|NCT00772941|144636556|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Chi-squared|||"The risk factor tested was concomitant therapies. The null hypothesis is that there is no difference between Varenicline with and without concomitant therapies in the frequency of Treatment Related Adverse Events."||||<0.001
72552789|NCT00772941|144636557|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Chi-squared|||"The risk factor tested was Weight at Baseline. The null hypothesis is that there is no association between Weight at Baseline and the frequency of Treatment Related Adverse Events."||||<0.001
72552790|NCT00772941|144636557|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Cochran-Armitage|||"The risk factor tested was Weight at Baseline. The null hypothesis is that there is no linear trend in the frequency of Treatment Related Adverse Events across increasing levels of Weight at Baseline."||||<0.001
72552791|NCT00772941|144636558|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Chi-squared|||"The risk factor tested was Tobacco consumption per day. The null hypothesis is that there is no association between Tobacco consumption per day and the efficacy of Varenicline."||||<0.001
72552792|NCT00772941|144636558|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Cochran-Armitage|||"The risk factor tested was Tobacco consumption per day. The null hypothesis is that there is no linear trend in the efficacy of Varenicline across increasing levels of tobacco consumption per day."||||<0.001
72552793|NCT00772941|144636559|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Chi-squared|||"The risk factor tested was prolonged administration after 12 weeks. The null hypothesis is that there is no difference between administration prolonged after 12 weeks and administration not prolonged after 12 weeks in the efficacy of Varenicline."||||<0.001
72552794|NCT00772941|144636560|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Chi-squared|||"The risk factor tested was antipsychotics as a concomitant drug. The null hypothesis is that there is no difference between Varenicline with and without antipsychotics as a concomitant drug in the efficacy of Varenicline."||||<0.001
72552795|NCT02251886|144636587|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.17||||0.48|TWO_SIDED|95.0|0.77|1.76|||Chi-squared|||||1.76|0.77|0.48
72552796|NCT02251886|144636587|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.0||||1|TWO_SIDED|95.0|0.69|1.46|||Chi-squared|||||1.46|0.69|1.00
72552797|NCT05169710|144636626|SUPERIORITY||Mean Difference (Final Values)|-3.94|STANDARD_ERROR_OF_MEAN|2.857||0.1718|TWO_SIDED|95.0|-9.64|1.75|||Mixed Models Analysis|||||1.75|-9.64|0.1718
72550789|NCT00262223|144631641|SUPERIORITY_OR_OTHER_LEGACY||Parameter Estimate|-16.15||||0.04|TWO_SIDED|95.0|-31.18|-1.13||A trend-level time-by-treatment interaction (p = .096) was probed for simple effects, which revealed a significantly greater reduction in CAPS scores at end-of-treatment in the SS+Sertraline group relative to the SS+Placebo group.|Generalized Estimating Equations|||Generalized estimating equations (GEE) were utilized to model PTSD outcomes. This method is an extension of the generalized linear model that handles correlated data arising from repeated measurements, requires no parametric distribution assumption, and provides robust inference with respect to misspecification of the within-subject correlation. A temporal within-subjects autoregressive \[AR(1)\] correlation matrix was used to model participants across timepoints.||-1.13|-31.18|0.04
72550790|NCT03828734|144631642|SUPERIORITY|||||||0.263|||||||ANOVA|||||||0.263
72550791|NCT03828734|144631643|SUPERIORITY||||||<|1e-06|||||||ANOVA|||||||<0.000001
72550792|NCT03828734|144631644|SUPERIORITY|||||||0.399|||||||ANOVA|||||||0.399
72550793|NCT01328093|144631655|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|-3.2|STANDARD_ERROR_OF_MEAN|0.7|<|0.001||95.0||||No adjustments for multiple comparisons were made. The treatment comparison was evaluated at a 2-sided significance level of 0.05.|Type III Tests|||||||<0.001
72550794|NCT01328093|144631656|SUPERIORITY_OR_OTHER_LEGACY|||||||0.11||95.0||||P-value is for ≥7% increase.|Cochran-Mantel-Haenszel|||||||0.110
72550795|NCT01328093|144631656|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||P-value is for ≥7% decrease.|Cochran-Mantel-Haenszel|||||||<0.001
72550796|NCT01328093|144631657|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|0.04|STANDARD_ERROR_OF_MEAN|0.04||0.353||95.0||||No adjustments for multiple comparisons were made. The treatment comparison was evaluated at a 2-sided significance level of 0.05.|Type III Tests|||||||0.353
72550797|NCT01328093|144631658|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|0.03|STANDARD_ERROR_OF_MEAN|0.09||0.698||95.0||||No adjustments for multiple comparisons were made. The treatment comparison was evaluated at a 2-sided significance level of 0.05.|Type III Tests|||||||0.698
72550798|NCT01328093|144631659|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|-0.01|STANDARD_ERROR_OF_MEAN|0.07||0.924||95.0||||No adjustments for multiple comparisons were made. The treatment comparison was evaluated at a 2-sided significance level of 0.05.|Type III Tests|||||||0.924
72550799|NCT01328093|144631660|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|3.55|STANDARD_ERROR_OF_MEAN|1.77||0.045||95.0||||P-value is for PANSS Total Score. No adjustments for multiple comparisons were made. The treatment comparison was evaluated at a 2-sided significance level of 0.05.|Type III Tests|||||||0.045
72550800|NCT01328093|144631660|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|1.21|STANDARD_ERROR_OF_MEAN|0.56||0.032||95.0||||P-value is for PANSS Positive Score. No adjustments for multiple comparisons were made. The treatment comparison was evaluated at a 2-sided significance level of 0.05.|Type III Tests|||||||0.032
72550801|NCT01328093|144631660|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|0.36|STANDARD_ERROR_OF_MEAN|0.54||0.509||95.0||||P-value is for PANSS Negative Score. No adjustments for multiple comparisons were made. The treatment comparison was evaluated at a 2-sided significance level of 0.05.|Type III Tests|||||||0.509
72550802|NCT01328093|144631660|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|2.05|STANDARD_ERROR_OF_MEAN|1.0||0.04||95.0||||P-value is for PANSS General Psychopathology Score. No adjustments for multiple comparisons were made. The treatment comparison was evaluated at a 2-sided significance level of 0.05.|Type III Tests|||||||0.040
72550803|NCT01328093|144631661|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|1.1|STANDARD_ERROR_OF_MEAN|2.1||0.601||95.0||||No adjustments for multiple comparisons were made. The treatment comparison was evaluated at a 2-sided significance level of 0.05.|Type III Tests|||||||0.601
72550804|NCT01328093|144631662|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|-0.02|STANDARD_ERROR_OF_MEAN|0.02||0.322||95.0||||P-value is for ER/Facility (Psych) visits. No adjustments for multiple comparisons were made. The treatment comparison was evaluated at a 2-sided significance level of 0.05.|Type III Tests|||||||0.322
72550805|NCT01328093|144631662|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|-0.04|STANDARD_ERROR_OF_MEAN|0.02||0.099||95.0||||P-value is for ER/Facility (Non-Psych) visits. No adjustments for multiple comparisons were made. The treatment comparison was evaluated at a 2-sided significance level of 0.05.|Type III Tests|||||||0.099
72550806|NCT01328093|144631662|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|0.02|STANDARD_ERROR_OF_MEAN|0.07||0.787||95.0||||P-value is for Outpatient (Non-Psych or Dentist) visits. No adjustments for multiple comparisons were made. The treatment comparison was evaluated at a 2-sided significance level of 0.05.|Type III Tests|||||||0.787
72550807|NCT01328093|144631663|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|0.02|STANDARD_ERROR_OF_MEAN|0.12||0.892||95.0||||No adjustments for multiple comparisons were made. The treatment comparison was evaluated at a 2-sided significance level of 0.05.|Type III Tests|||||||0.892
72550808|NCT01328093|144631664|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|-0.8|STANDARD_ERROR_OF_MEAN|1.6||0.63||95.0||||No adjustments for multiple comparisons were made. The treatment comparison was evaluated at a 2-sided significance level of 0.05.|Type III Tests|||||||0.630
72552798|NCT05169710|144636626|SUPERIORITY||Mean Difference (Final Values)|-6.34|STANDARD_ERROR_OF_MEAN|2.837||0.0286|TWO_SIDED|95.0|-11.99|-0.68|||Mixed Models Analysis|||||-0.68|-11.99|0.028600
72412990|NCT00780962|144334503|SUPERIORITY||Percentage Difference|0.6|||>|0.5|TWO_SIDED|95.0|-4.8|6.0|||Wald|||"The study was powered to find a 10% absolute risk reduction in the rate of contrast-induced nephropathy (a=.05, 90% power). We initially estimated the need for 600 patients and repowered to 800 patients after the 1st interim analysis. The study was halted for futility at the 2nd interim analysis.~Reported here 357 (89.4%) of the 399 enrolled subjects who completed a second blood draw at the time the study closed."||6.0|-4.8|>0.5
72550809|NCT01328093|144631665|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|-0.5|STANDARD_ERROR_OF_MEAN|1.2||0.679||95.0||||No adjustments for multiple comparisons were made. The treatment comparison was evaluated at a 2-sided significance level of 0.05.|Type III Tests|||||||0.679
72550810|NCT01328093|144631666|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|0.17|STANDARD_ERROR_OF_MEAN|0.09||0.055||95.0||||No adjustments for multiple comparisons were made. The treatment comparison was evaluated at a 2-sided significance level of 0.05.|Type III Tests|||||||0.055
72550811|NCT01328093|144631667|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|0.15|STANDARD_ERROR_OF_MEAN|1.11||0.891||95.0||||No adjustments for multiple comparisons were made. The treatment comparison was evaluated at a 2-sided significance level of 0.05.|Type III Tests|||||||0.891
72550812|NCT01328093|144631669|SUPERIORITY_OR_OTHER_LEGACY|||||||0.064||95.0||||P-value is for Treatment-Emergent Suicidal Ideation.|Fisher Exact|||||||0.064
72412991|NCT01910519|144334530|OTHER|||||||0.0039|||||||ANOVA|||Correlation of vaccine-induced blood transcription modules (BTMs) M183-TBA at day 1 with MN titers at day 42||||0.0039
72550813|NCT01328093|144631669|SUPERIORITY_OR_OTHER_LEGACY|||||||0.205||95.0||||P-value is for Treatment-Emergent Suicidal Behavior.|Fisher Exact|||||||0.205
72550814|NCT05150964|144631674|OTHER||||||<|0.05||||||Significance was indicated by p \<. 05, Cohen's d was calculated to indicate effect size.|Mixed Models Analysis|||"A Linear Mixed Model Analysis was performed. The hearing aid prescription (NAL/National Acoustic Laboratory or DSL/Desired Sensation Level) and ASG (Adaptive Situational Gain) setting (on, off) were entered as fixed factors while the individual participants were entered as a random factor.~Null hypothesis: The hearing aid fitting prescription will have no effect on the speech reception thresholds."||||<0.05
72550815|NCT05150964|144631674|OTHER||||||>|0.05||||||Significance was indicated by p \<. 05, Cohen's d was calculated to indicate effect size.|Mixed Models Analysis|||"A Linear Mixed Model Analysis was performed. The hearing aid prescription (NAL/National Acoustic Laboratory or DSL/Desired Sensation Level) and ASG (Adaptive Situational Gain) setting (on, off) were entered as fixed factors while the individual participants were entered as a random factor.~Null hypothesis: The ASG setting will have no effect on the speech reception threshold."||||>0.05
72550816|NCT05150964|144631675|OTHER||||||<|0.05||||||Significance was indicated by p \<. 05 and Cohen's d was calculated to indicate effect size.|Mixed Models Analysis|||"A Linear Mixed Model Analysis was performed. The hearing aid prescription (DSL, NAL) and ASG setting (on, off) were entered as fixed factors while the individual participants were entered as a random factor. An additional fixed factor of presentation level (40, 70 dB SPL) was added to the analyses.~Null Hypothesis: The ASG setting will have no effect on the Word Recognition Scores."||||<0.05
72550817|NCT05150964|144631675|OTHER||||||<|0.05||||||Significance was indicated by p \<. 05 and Cohen's d was calculated to indicate effect size.|Mixed Models Analysis|||"A Linear Mixed Model Analysis was performed. The hearing aid prescription (DSL, NAL) and ASG setting (on, off) were entered as fixed factors while the individual participants were entered as a random factor. An additional fixed factor of presentation level (40, 70 dB SPL) was added to the analyses.~Null Hypothesis: The presentation level will have no effect on the Word Recognition Scores."||||<0.05
72550818|NCT05150964|144631675|OTHER||||||<|0.05||||||Significance was indicated by p \<. 05 and Cohen's d was calculated to indicate effect size.|Mixed Models Analysis|||"A Linear Mixed Model Analysis was performed. The hearing aid prescription (DSL, NAL) and ASG setting (on, off) were entered as fixed factors while the individual participants were entered as a random factor. An additional fixed factor of presentation level (40, 70 dB SPL) was added to the analyses.~Null Hypothesis: Hearing aid prescription will have no effect on the Word Recognition Scores."||||<0.05
72550819|NCT05150964|144631676|OTHER||||||<|0.05||||||Significance was indicated by p \<. 05 and Cohen's d was calculated to indicate effect size.|Mixed Models Analysis|||"A Linear Mixed Model Analysis was performed. The hearing aid prescription (DSL, NAL) and ASG setting (on, off) were entered as fixed factors while the individual participants were entered as a random factor. An additional fixed factor of presentation level (40, 70 dB SPL) was added to the analyses.~Null hypothesis: Presentation level will have no effect on multi-word recognition scores."||||<0.05
72550820|NCT05150964|144631676|OTHER||||||>|0.05||||||Significance was indicated by p \<. 05 and Cohen's d was calculated to indicate effect size.|Mixed Models Analysis|||"A Linear Mixed Model Analysis was performed. The hearing aid prescription (DSL, NAL) and ASG setting (on, off) were entered as fixed factors while the individual participants were entered as a random factor. An additional fixed factor of presentation level (40, 70 dB SPL) was added to the analyses.~Null hypothesis: The ASG setting will have no effect on multi-word recognition scores."||||>0.05
72550821|NCT05150964|144631676|OTHER||||||>|0.05||||||Significance was indicated by p \<. 05 and Cohen's d was calculated to indicate effect size.|Mixed Models Analysis|||"A Linear Mixed Model Analysis was performed. The hearing aid prescription (DSL, NAL) and ASG setting (on, off) were entered as fixed factors while the individual participants were entered as a random factor. An additional fixed factor of presentation level (40, 70 dB SPL) was added to the analyses.~Null hypothesis: Hearing aid prescription will have no effect on multi-word recognition scores."||||>0.05
72550822|NCT05150964|144631677|OTHER||||||<|0.05||||||Significance was indicated by p \<. 05 and Cohen's d was calculated to indicate effect size.|Mixed Models Analysis|||"A Linear Mixed Model Analysis was performed. The hearing aid prescription (DSL, NAL) and ASG setting (on, off) were entered as fixed factors while the individual participants were entered as a random factor. An additional fixed factor of presentation level (40, 70 dB SPL) was added to the analyses.~Null hypothesis: Presentation level will have no effect on Nonword Detection scores."||||<0.05
72550823|NCT05150964|144631677|OTHER||||||<|0.05||||||Significance was indicated by p \<. 05 and Cohen's d was calculated to indicate effect size.|Mixed Models Analysis|||"A Linear Mixed Model Analysis was performed. The hearing aid prescription (DSL, NAL) and ASG setting (on, off) were entered as fixed factors while the individual participants were entered as a random factor. An additional fixed factor of presentation level (40, 70 dB SPL) was added to the analyses.~Null hypothesis: Hearing aid prescription will have no effect on Nonword Detection scores."||||<0.05
72550824|NCT05150964|144631677|OTHER||||||>|0.05||||||Significance was indicated by p \<. 05 and Cohen's d was calculated to indicate effect size.|Mixed Models Analysis|||"A Linear Mixed Model Analysis was performed. The hearing aid prescription (DSL, NAL) and ASG setting (on, off) were entered as fixed factors while the individual participants were entered as a random factor. An additional fixed factor of presentation level (40, 70 dB SPL) was added to the analyses.~Null hypothesis: The ASG setting will have no effect on Nonword Detection scores."||||>0.05
72550825|NCT05150964|144631678|OTHER||||||>|0.05||||||Significance was indicated by p \<. 05 and Cohen's d was calculated to indicate effect size.|Mixed Models Analysis|||"A Linear Mixed Model Analysis was performed. The hearing aid prescription (DSL, NAL) and ASG setting (on, off) were entered as fixed factors while the individual participants were entered as a random factor. An additional fixed factor of presentation level (40, 70 dB SPL) was added to the analyses.~Null hypothesis: The ASG setting will have no effect on Rapid Word Learning scores."||||>0.05
72550826|NCT05150964|144631678|OTHER||||||>|0.05||||||Significance was indicated by p \<. 05 and Cohen's d was calculated to indicate effect size.|Mixed Models Analysis|||"A Linear Mixed Model Analysis was performed. The hearing aid prescription (DSL, NAL) and ASG setting (on, off) were entered as fixed factors while the individual participants were entered as a random factor. An additional fixed factor of presentation level (40, 70 dB SPL) was added to the analyses.~Null hypothesis: Presentation level will have no effect on Rapid Word Learning scores."||||>0.05
72550827|NCT05150964|144631678|OTHER||||||>|0.05||||||Significance was indicated by p \<. 05 and Cohen's d was calculated to indicate effect size.|Mixed Models Analysis|||"A Linear Mixed Model Analysis was performed. The hearing aid prescription (DSL, NAL) and ASG setting (on, off) were entered as fixed factors while the individual participants were entered as a random factor. An additional fixed factor of presentation level (40, 70 dB SPL) was added to the analyses.~Null hypothesis: Hearing aid prescripton will have no effect on Rapid Word Learning scores."||||>0.05
72550828|NCT00832377|144631703|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Week 12 peak IOP vs. baseline|paired t-test|||||||<0.0001
72550829|NCT00832377|144631704|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Week 12 trough IOP vs. baseline|paired t-test|||||||<0.0001
72550830|NCT00832377|144631705|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Week 12 8-HR IOP vs. baseline|paired t-test|||||||<0.0001
72552799|NCT05169710|144636627|SUPERIORITY||Mean Difference (Final Values)|-0.11|STANDARD_ERROR_OF_MEAN|0.308||0.7314|TWO_SIDED|95.0|-0.72|0.51|||Mixed Models Analysis|||||0.51|-0.72|0.7314
72552800|NCT05169710|144636627|SUPERIORITY||Mean Difference (Final Values)|-0.31|STANDARD_ERROR_OF_MEAN|0.305||0.3169|TWO_SIDED|95.0|-0.91|0.3|||Mixed Models Analysis|||||0.3|-0.91|0.3169
72412992|NCT01910519|144334530|OTHER|||||||0.0368|||||||ANOVA|||Correlation of vaccine-induced blood transcription modules (BTMs) M115-cytokines-receptors cluster at day 1 with MN titers at day 42||||0.0368
72552801|NCT02729714|144636628|SUPERIORITY|||||||0.72|||||||Wilcoxon (Mann-Whitney)|||||||0.72
72550831|NCT02096718|144631731|SUPERIORITY_OR_OTHER||Ratio of gmeans|122.23|STANDARD_DEVIATION|28.3|||TWO_SIDED|90.0|95.743|156.045|||ANOVA||Relative bioavailability comparison of afatinib for moderate vs. normal matched with moderate patients was estimated by the ratios of the geometric means (gMean). Standard deviation is actually Inter individual geometric coefficient variation (gCV).|The ANOVA model was fitted using log-transformed values. The difference between the expected means of each comparison was estimated by the difference in the corresponding Least Square Means (point estimate), and 2-sided 90% confidence intervals based on the t-distribution. These quantities were then back-transformed to the original scale to give the point estimator (gMean), and interval estimates for the intersubject ratio of the gMeans for each renal function group.||156.045|95.743|
72550832|NCT02096718|144631731|SUPERIORITY_OR_OTHER||Ratio of gmeans|149.97|STANDARD_DEVIATION|41.9|||TWO_SIDED|90.0|105.266|213.671|||ANOVA||Relative bioavailability comparison of afatinib for severe vs. normal matched with severe patients was estimated by the ratios of the geometric means (gMean). Standard deviation is actually Inter individual geometric coefficient variation (gCV).|The ANOVA model was fitted using log-transformed values. The difference between the expected means of each comparison was estimated by the difference in the corresponding Least Square Means (point estimate), and 2-sided 90% confidence intervals based on the t-distribution. These quantities were then back-transformed to the original scale to give the point estimator (gMean), and interval estimates for the intersubject ratio of the gMeans for each renal function group.||213.671|105.266|
72550833|NCT02096718|144631732|SUPERIORITY_OR_OTHER||Ratio of gmeans|101.16|STANDARD_DEVIATION|38.5|||TWO_SIDED|90.0|72.931|140.309|||ANOVA||Relative bioavailability comparison of afatinib for moderate vs. normal matched with moderate patients was estimated by the ratios of the geometric means (gMean). Standard deviation is actually Inter individual geometric coefficient variation (gCV).|The ANOVA model was fitted using log-transformed values. The difference between the expected means of each comparison was estimated by the difference in the corresponding Least Square Means (point estimate), and 2-sided 90% confidence intervals based on the t-distribution. These quantities were then back-transformed to the original scale to give the point estimator (gMean), and interval estimates for the intersubject ratio of the gMeans for each renal function group.||140.309|72.931|
72550834|NCT02096718|144631732|SUPERIORITY_OR_OTHER||Ratio of gmeans|121.71|STANDARD_DEVIATION|34.2|||TWO_SIDED|90.0|90.79|163.162|||ANOVA||Relative bioavailability comparison of afatinib for severe vs. normal matched with severe patients was estimated by the ratios of the geometric means (gMean). Standard deviation is actually Inter individual geometric coefficient variation (gCV).|The ANOVA model was fitted using log-transformed values. The difference between the expected means of each comparison was estimated by the difference in the corresponding Least Square Means (point estimate), and 2-sided 90% confidence intervals based on the t-distribution. These quantities were then back-transformed to the original scale to give the point estimator (gMean), and interval estimates for the intersubject ratio of the gMeans for each renal function group.||163.162|90.790|
72550835|NCT02096718|144631733|SUPERIORITY_OR_OTHER||Ratio of gmeans|122.44|STANDARD_DEVIATION|28.0|||TWO_SIDED|90.0|96.141|155.928|||ANOVA||Relative bioavailability comparison of afatinib for moderate vs. normal matched with moderate patients was estimated by the ratios of the geometric means (gMean). Standard deviation is actually Inter individual geometric coefficient variation (gCV).|The ANOVA model was fitted using log-transformed values. The difference between the expected means of each comparison was estimated by the difference in the corresponding Least Square Means (point estimate), and 2-sided 90% confidence intervals based on the t-distribution. These quantities were then back-transformed to the original scale to give the point estimator (gMean), and interval estimates for the intersubject ratio of the gMeans for each renal function group.||155.928|96.141|
72550836|NCT02096718|144631733|SUPERIORITY_OR_OTHER||Ratio of gmeans|150.08|STANDARD_DEVIATION|41.5|||TWO_SIDED|90.0|105.626|213.25|||ANOVA||Relative bioavailability comparison of afatinib for severe vs. normal matched with severe patients was estimated by the ratios of the geometric means (gMean). Standard deviation is actually Inter individual geometric coefficient variation (gCV).|The ANOVA model was fitted using log-transformed values. The difference between the expected means of each comparison was estimated by the difference in the corresponding Least Square Means (point estimate), and 2-sided 90% confidence intervals based on the t-distribution. These quantities were then back-transformed to the original scale to give the point estimator (gMean), and interval estimates for the intersubject ratio of the gMeans for each renal function group.||213.250|105.626|
72550837|NCT03682900|144631734|SUPERIORITY||||||=|0||||||A one tailed test was used, as the intervention is expected to be superior than the control group. The criterion for significance was p \<. 05.|Mixed Models Analysis|There were no adjustments made for multiple comparisons.||Data were analyzed using a general linear mixed model with students nested within schools and schools nested within condition.||||= .000
72552802|NCT02729714|144636629|SUPERIORITY|||||||0.51|||||||Wilcoxon (Mann-Whitney)|||||||0.51
72552803|NCT02729714|144636630|SUPERIORITY|||||||0.81|||||||Wilcoxon (Mann-Whitney)|||||||0.81
72552804|NCT02729714|144636631|SUPERIORITY|||||||0.004|||||||Wilcoxon (Mann-Whitney)|||||||0.004
72552805|NCT02729714|144636632|SUPERIORITY|||||||0.32|||||||Wilcoxon (Mann-Whitney)|||||||0.32
72552806|NCT02729714|144636633|SUPERIORITY|||||||0.098|||||||Wilcoxon (Mann-Whitney)|||||||0.098
72552807|NCT02729714|144636634|SUPERIORITY|||||||0.2|||||||Wilcoxon (Mann-Whitney)|||||||0.2
72550838|NCT03682900|144631735|SUPERIORITY||||||=|0||||||"The a prior threshold for statistical significance is set at p\<.05; one tailed test, as the intervention is expected to be superior than the control group.~The p-value is not adjusted for multiple comparisons."|Mixed Models Analysis|||Data were analyzed using a general linear mixed model with students nested within schools and schools nested within condition||||= .000
72550839|NCT03682900|144631736|SUPERIORITY||||||=|0.044||||||"The a prior threshold for statistical significance is set at p\<.05; one tailed test, as the intervention is expected to be superior than the control group.~The p-value is not adjusted for multiple comparisons."|Mixed Models Analysis|||Data were analyzed using a general linear mixed model with students nested within schools and schools nested within condition.||||=.044
72550840|NCT03682900|144631737|SUPERIORITY||||||=|0.033||||||The p-value is not adjusted for multiple comparisons. The a priori threshold for significance is p\<.05.|Mixed Models Analysis|||Data were analyzed using a general linear mixed model with students nested within schools and schools nested within condition.||||=.033
72550841|NCT03682900|144631738|SUPERIORITY||||||<|0.001||||||All probabilities for secondary outcomes were listed as p = .000 within the analysis program. A p value of \< .05 is considered significant. All statistical tests are one-tailed. The p-value is not adjusted for multiple comparisons.|Mixed Models Analysis|||Data were analyzed using a general linear mixed model with students nested within schools and schools nested within condition.||||<.001
72550842|NCT03682900|144631739|SUPERIORITY||||||<|0.001||||||All probabilities for secondary outcomes were listed as p = .000 within the analysis program. A p value of \< .05 is considered significant. All statistical tests are one-tailed. The p-value is not adjusted for multiple comparisons.|Mixed Models Analysis|||Data were analyzed using a general linear mixed model with students nested within schools and schools nested within condition.||||<.001
72550843|NCT03682900|144631740|SUPERIORITY||||||<|0.001||||||All probabilities for secondary outcomes were listed as p = .000 within the analysis program. A p value of \< .05 is considered significant. All statistical tests are one-tailed. The p-value is not adjusted for multiple comparisons.|Mixed Models Analysis|||Data were analyzed using a general linear mixed model with students nested within schools and schools nested within condition.||||<.001
72550844|NCT03682900|144631741|SUPERIORITY||||||<|0.001||||||"The a prior threshold for statistical significance is set at p\<.05; one tailed test, as the intervention is expected to be superior than the control group.~The p-value is not adjusted for multiple comparisons."|Mixed Models Analysis|||Data were analyzed using a general linear mixed model with students nested within schools and schools nested within condition.||||<.001
72550845|NCT03682900|144631742|SUPERIORITY||||||<|0.001||||||All probabilities for secondary outcomes were listed as p = .000 within the analysis program. A p value of \< .05 is considered significant. All statistical tests are one-tailed. The p-value is not adjusted for multiple comparisons.|Mixed Models Analysis|||Data were analyzed using a general linear mixed model with students nested within schools and schools nested within condition.||||<.001
72550846|NCT03682900|144631743|SUPERIORITY||||||<|0.001||||||All probabilities for secondary outcomes were listed as p = .000 within the analysis program. A p value of \< .05 is considered significant. All statistical tests are one-tailed. The p-value is not adjusted for multiple comparisons.|Mixed Models Analysis|||Data were anlyzed using a general linear mixed model with students nested within schools and schools nested within condition.||||<.001
72550847|NCT03682900|144631744|SUPERIORITY||||||<|0.001||||||All probabilities for secondary outcomes were listed as p = .000 within the analysis program. A p value of \< .05 is considered significant. All statistical tests are one-tailed. The p-value is not adjusted for multiple comparisons.|Mixed Models Analysis|||Data were analyzed using a general linear mixed model with students nested within schools and schools nested within condition.||||<.001
72550848|NCT03682900|144631745|SUPERIORITY||||||<|0.001||||||All probabilities for secondary outcomes were listed as p = .000 within the analysis program. A p value of \< .05 is considered significant. All statistical tests are one-tailed. The p-value is not adjusted for multiple comparisons.|Mixed Models Analysis|||Data were anlyzed using a general linear mixed model with students nested within schools and schools nested within condition.||||<.001
72550849|NCT03682900|144631746|SUPERIORITY||||||<|0.001||||||All probabilities for secondary outcomes were listed as p = .000 within the analysis program. A p value of \< .05 is considered significant. All statistical tests are one-tailed. The p-value is not adjusted for multiple comparisons.|Mixed Models Analysis|||Data were analyzed using a gneral linear mixed model with students nested within schools and schools nested within condition.||||<.001
72550850|NCT03682900|144631747|SUPERIORITY||||||<|0.001||||||All probabilities for secondary outcomes were listed as p = .000 within the analysis program. A p value of \< .05 is considered significant. All statistical tests are one-tailed. The p-value is not adjusted for multiple comparisons.|Mixed Models Analysis|||Data were anlayzed using a general linear mixed model with students nested within schools and schools within condition.||||<.001
72550851|NCT03682900|144631748|SUPERIORITY||||||<|0.001||||||All probabilities for secondary outcomes were listed as p = .000 within the analysis program. Apriori, a p value of \< .05 is considered significant. All statistical tests are one-tailed. The p-value is not adjusted for multiple comparisons.|Mixed Models Analysis|||Data were analyzed uisng a general linear mixed model with students nested within schools and schools nested within condition.||||<.001
72550852|NCT03682900|144631749|SUPERIORITY||||||<|0.001||||||All probabilities for secondary outcomes were listed as p = .000 within the analysis program. A p value of \< .05 is a priori considered significant. All statistical tests are one-tailed. The p-value is not adjusted for multiple comparisons.|Mixed Models Analysis|||Data were analyzed using a general linear model with students nested within schools and schools nested within condition.||||<.001
72550853|NCT03682900|144631750|SUPERIORITY||||||<|0.001||||||All probabilities for secondary outcomes were listed as p = .000 within the analysis program. A p value of \< .05 is considered significant. All statistical tests are one-tailed. The p-value is not adjusted for multiple comparisons.|Mixed Models Analysis|||Data were analyzed using a general linear mixed model with students nested within schools and schools nested within condition.||||<.001
72583576|NCT03349060|144698358|SUPERIORITY||Difference in Percentage|43.3|||<|0.0001|TWO_SIDED|95.0|33.1|53.6|||Cochran-Mantel-Haenszel|||Week 2: Each complete imputed data set was analyzed using the CMH risk difference method adjusting by randomization strata, separately for each week. Results from multiply imputed data sets were combined using Rubin's rules to obtain treatment difference, 95% CI and p-value.||53.6|33.1|<0.0001
72550854|NCT03682900|144631751|SUPERIORITY||||||<|0.001||||||All probabilities for secondary outcomes were listed as p = .000 within the analysis program. A p value of \< .05 is considered significant. All statistical tests are one-tailed. The p-value is not adjusted for multiple comparisons.|Mixed Models Analysis|||Data were analyzed using a general linear mixed model with students nested within schools and schools nested within condition.||||<.001
72550855|NCT03682900|144631752|SUPERIORITY||||||<|0.001||||||All probabilities for secondary outcomes were listed as p = .000 within the analysis program. A p value of \< .05 is considered significant. All statistical tests are one-tailed. The p-value is not adjusted for multiple comparisons.|Mixed Models Analysis|||Data were anlyzed using a general linear model mixed model with students nested within schools and schools nested within condition.||||<.001
72550856|NCT03682900|144631753|SUPERIORITY||||||<|0.001||||||All probabilities for secondary outcomes were listed as p = .000 within the analysis program. A p value of \< .05 is considered significant. All statistical tests are one-tailed. The p-value is not adjusted for multiple comparisons.|Mixed Models Analysis|||Data were analyzed using a general linear mixed model with students nested within schools and schools nested within condition.||||<.001
72550857|NCT03682900|144631754|SUPERIORITY||||||<|0.001||||||All probabilities for secondary outcomes were listed as p = .000 within the analysis program. A p value of \< .05 is considered significant. All statistical tests are one-tailed. The p-value is not adjusted for multiple comparisons.|Mixed Models Analysis|||Data were analyzed using a general linear mixed model with students nested within schols and schools nested within condition.||||<.001
72550858|NCT03682900|144631755|SUPERIORITY||||||<|0.001||||||All probabilities for secondary outcomes were listed as p = .000 within the analysis program. A p value of \< .05 is considered significant. All statistical tests are one-tailed. The p-value is not adjusted for multiple comparisons.|Mixed Models Analysis|||Data were analyzed using a general linear mixed model with students nested within schools and schools nested within condition.||||<.001
72583577|NCT03349060|144698358|SUPERIORITY||Difference in Percentage|12.5||||0.1138|TWO_SIDED|95.0|-3.0|28.0|||Cochran-Mantel-Haenszel|||Week 4: Each complete imputed data set was analyzed using the CMH risk difference method adjusting by randomization strata, separately for each week. Results from multiply imputed data sets were combined using Rubin's rules to obtain treatment difference, 95% CI and p-value.||28.0|-3.0|0.1138
72583578|NCT03349060|144698358|SUPERIORITY||Difference in Percentage|41.8|||<|0.0001|TWO_SIDED|95.0|26.2|57.4|||Cochran-Mantel-Haenszel|||Week 4: Each complete imputed data set was analyzed using the CMH risk difference method adjusting by randomization strata, separately for each week. Results from multiply imputed data sets were combined using Rubin's rules to obtain treatment difference, 95% CI and p-value.||57.4|26.2|<0.0001
72583579|NCT03349060|144698358|SUPERIORITY||Difference in Percentage|28.7|||<|0.0001|TWO_SIDED|95.0|15.3|42.1|||Cochran-Mantel-Haenszel|||Week 12: Each complete imputed data set was analyzed using the CMH risk difference method adjusting by randomization strata, separately for each week. Results from multiply imputed data sets were combined using Rubin's rules to obtain treatment difference, 95% CI and p-value.||42.1|15.3|<0.0001
72583580|NCT03349060|144698358|SUPERIORITY||Difference in Percentage|47.8|||<|0.0001|TWO_SIDED|95.0|34.6|61.1|||Cochran-Mantel-Haenszel|||Week 12: Each complete imputed data set was analyzed using the CMH risk difference method adjusting by randomization strata, separately for each week. Results from multiply imputed data sets were combined using Rubin's rules to obtain treatment difference, 95% CI and p-value.||61.1|34.6|<0.0001
72583581|NCT03349060|144698359|SUPERIORITY||Difference in least squares (LS) mean|-1.0|||<|0.0001|TWO_SIDED|95.0|-1.4|-0.6|||Mixed Models Analysis|||Change at Week 2: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-0.6|-1.4|<0.0001
72583582|NCT03349060|144698359|SUPERIORITY||Difference in LS mean|-1.6|||<|0.0001|TWO_SIDED|95.0|-2.0|-1.2|||Mixed Models Analysis|||Change at Week 2: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-1.2|-2.0|<0.0001
72583583|NCT03349060|144698359|SUPERIORITY||Difference in LS mean|-1.1|||<|0.0001|TWO_SIDED|95.0|-1.6|-0.6|||Mixed Models Analysis|||Change at Week 4: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-0.6|-1.6|<0.0001
72583584|NCT03349060|144698359|SUPERIORITY||Difference in LS mean|-2.2|||<|0.0001|TWO_SIDED|95.0|-2.8|-1.7|||Mixed Models Analysis|||Change at Week 4: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-1.7|-2.8|<0.0001
72583585|NCT03349060|144698359|SUPERIORITY||Difference in LS mean|-0.9||||0.0035|TWO_SIDED|95.0|-1.5|-0.3|||Mixed Models Analysis|||Change at Week 8: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-0.3|-1.5|0.0035
72583586|NCT03349060|144698359|SUPERIORITY||Difference in LS mean|-1.9|||<|0.0001|TWO_SIDED|95.0|-2.5|-1.3|||Mixed Models Analysis|||Change at Week 8: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-1.3|-2.5|<0.0001
72550859|NCT01941030|144631777|OTHER|No pre-specified hypothesis test or power calculation specified in protocol.||||||0.022|||||||Wilcoxon (Mann-Whitney)|Data failed to meet the assumption for normality per the Shapiro-Wilk test.||Null hypothesis: no difference in populations for post-balloon angioplasty reduction of calcium out of lumen gain.||||0.0220
72550860|NCT01941030|144631778|OTHER|No pre-specified hypothesis test or power calculation specified in protocol.||||||0.6228|||||||t-test, 2 sided|||Null hypothesis: no difference in populations for post-balloon angioplasty minimum lumen area stenosis.||||0.6228
72583587|NCT03349060|144698359|SUPERIORITY||Difference in LS mean|-1.1||||0.001|TWO_SIDED|95.0|-1.7|-0.4|||Mixed Models Analysis|||Change at Week 12: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-0.4|-1.7|0.0010
72412993|NCT01910519|144334530|OTHER|||||||0.0465|||||||ANOVA|||Correlation of vaccine-induced blood transcription modules (BTMs) M74-transcriptional targets of glucocorticoid receptor at day 1 with MN titers at day 42||||0.0465
72550861|NCT01941030|144631779|OTHER|No pre-specified hypothesis test or power calculation specified in protocol.||||||0.4528|||||||Wilcoxon (Mann-Whitney)|Data failed to meet the assumption for normality per the Shapiro-Wilk test.||Null hypothesis: no difference in populations for post-balloon angioplasty plaque area.||||0.4528
72550862|NCT01941030|144631780|OTHER|No pre-specified hypothesis test or power calculation specified in protocol.||||||0.3573|||||||Wilcoxon (Mann-Whitney)|Data failed to meet the assumption for normality per the Shapiro-Wilk test.||Null hypothesis: no difference in populations for post-balloon angioplasty dense calcium area.||||0.3573
72550863|NCT01941030|144631781|OTHER|No pre-specified hypothesis test or power calculation specified in protocol.||||||0.6073|||||||Wilcoxon (Mann-Whitney)|Data failed to meet the assumption for normality per the Shapiro-Wilk test.||Null hypothesis: no difference in populations for post-balloon angioplasty necrotic core area.||||0.6073
72550864|NCT01941030|144631782|OTHER|No pre-specified hypothesis test or power calculation specified in protocol.||||||0.2149|||||||Wilcoxon (Mann-Whitney)|Data failed to meet the assumption for normality per the Shapiro-Wilk test.||Null hypothesis: no difference in populations for post-balloon angioplasty fibrous plaque area.||||0.2149
72550865|NCT01941030|144631783|OTHER|No pre-specified hypothesis test or power calculation specified in protocol.||||||0.0579|||||||Wilcoxon (Mann-Whitney)|Data failed to meet the assumption for normality per the Shapiro-Wilk test.||Null hypothesis: no difference in populations for post-balloon angioplasty fibrofatty plaque area.||||0.0579
72550866|NCT01941030|144631784|OTHER|No pre-specified hypothesis test or power calculation specified in protocol.||||||0.076|||||||t-test, 2 sided|||Null hypothesis: no difference in populations for post-final balloon FFR value with 600 mcg adenosine.||||0.076
72550867|NCT01941030|144631784|OTHER|No pre-specified hypothesis test or power calculation specified in protocol.||||||0.205|||||||t-test, 2 sided|||Null hypothesis: no difference in populations for post-final balloon FFR value with 1200 mcg adenosine.||||0.205
72550868|NCT02268500|144631859|SUPERIORITY|||||||0.89|||||||Chi-squared|||||||0.89
72550869|NCT02268500|144631860|SUPERIORITY|||||||0.43|||||||Chi-squared|||||||0.43
72550870|NCT02268500|144631861|SUPERIORITY|||||||0.03|||||||Chi-squared|||||||0.03
72550871|NCT02268500|144631862|SUPERIORITY|||||||0.76|||||||Chi-squared|||||||0.76
72550872|NCT02268500|144631863|SUPERIORITY|||||||0.01|||||||Chi-squared|||||||0.01
72550873|NCT01993875|144631866|SUPERIORITY|||||||0.129||||||Treatment p-value is from an analysis of co-variance (ANCOVA) using the SBM rate as the dependent variable, treatment as fixed effect, and baseline rate as random effect.|ANCOVA|||||||0.1290
72550874|NCT01993875|144631867|SUPERIORITY|||||||0.129||||||Treatment p-value is from an ANCOVA using the SBM rate as the dependent variable, treatment as fixed effect, and baseline rate as random effect.|ANCOVA|||||||0.1290
72550875|NCT01993875|144631868|SUPERIORITY|||||||0.2177||||||Treatment p-value is from an ANCOVA using the mean stool consistency score as the dependent variable, treatment as fixed effect, and the baseline consistency score as random effect.|ANCOVA|||||||0.2177
72550876|NCT01993875|144631869|SUPERIORITY|||||||0.2177||||||Treatment p-value is from an ANCOVA using the mean stool consistency score as the dependent variable, treatment as fixed effect, and the baseline consistency score as random effect.|ANCOVA|||||||0.2177
72550877|NCT01993875|144631870|SUPERIORITY|||||||0.0664||||||Treatment p-value is from an ANCOVA using the mean straining score as the dependent variable, treatment as fixed effect, and the baseline straining score as random effect.|ANCOVA|||||||0.0664
72550878|NCT01993875|144631871|SUPERIORITY|||||||0.0664||||||Treatment p-value is from an ANCOVA using the mean straining score as the dependent variable, treatment as fixed effect, and the baseline mean score as random effect.|ANCOVA|||||||0.0664
72550879|NCT01874951|144631878|NON_INFERIORITY_OR_EQUIVALENCE|An initial power analysis at the time of protocol development suggested that with 6 patients in each treatment group, we could expect a 79% chance of achieving significance (2-sided p \< 0.05) if the true response rate to low-dose naltrexone (LDN) was 80% and the true placebo response rate was 20%.||||||0.55||||||Threshold of statistical significance is 0.05.|Chi-squared|Chi-squared value was 1.5.||Response rates were based on attaining a reduction in the HAM-D-17 scale of 50% or greater compared to baseline. We hypothesized that naltrexone would produce a significantly greater response rate than placebo.||||0.55
72583588|NCT03349060|144698359|SUPERIORITY||Difference in LS mean|-2.1|||<|0.0001|TWO_SIDED|95.0|-2.7|-1.4|||Mixed Models Analysis|||Change at Week 12: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-1.4|-2.7|<0.0001
72583589|NCT03349060|144698360|SUPERIORITY||Difference in LS mean|-1.3||||0.0002|TWO_SIDED|95.0|-2.0|-0.6|||Mixed Models Analysis|||MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-0.6|-2.0|0.0002
72550880|NCT03290326|144631897|OTHER||||||<|0.01|||||||ANOVA|||One-way ANOVA was conducted to compare the effect of 40Hz tACS on EEG gamma-band spectral power. Power changes were expressed as percentage relative power variations, accordingly with the event-related synchronization/desynchronization (ERS/ERD) index.||||< 0.01
72550881|NCT03422653|144631901|SUPERIORITY||Odds Ratio (OR)|2.72|||<|0.001|TWO_SIDED|95.0|1.72|4.3|||Cui, Hung, Wang|||||4.30|1.72|<0.001
72550882|NCT03422653|144631902|SUPERIORITY||Mean Difference (Final Values)|-1.3|STANDARD_ERROR_OF_MEAN|0.38|<|0.001|TWO_SIDED|95.0|-2.0|-0.5|||ANCOVA|||||-0.5|-2.0|<0.001
72550883|NCT03422653|144631903|SUPERIORITY||Mean Difference (Final Values)|-5.1|STANDARD_ERROR_OF_MEAN|1.44|<|0.001|TWO_SIDED|95.0|-8.0|-2.3|||ANCOVA|||||-2.3|-8.0|<0.001
72550884|NCT03422653|144631904|SUPERIORITY||Odds Ratio (OR)|2.89|||<|0.001|TWO_SIDED|95.0|1.75|4.76|||Cui, Hung, Wang|||||4.76|1.75|<0.001
72550885|NCT01101022|144631905|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-11.2|||<|0.0001|TWO_SIDED|95.0|-15.9|-6.4|||ANCOVA|||||-6.4|-15.9|<0.0001
72550886|NCT01101022|144631906|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|21.6|||<|0.0001|TWO_SIDED|95.0|13.5|29.7|||ANCOVA|||Performance and Daily Functioning||29.7|13.5|<0.0001
72550887|NCT01101022|144631906|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|14.9|||<|0.0001|TWO_SIDED|95.0|7.8|22.0|||ANCOVA|||Daily Interference||22.0|7.8|<0.0001
72550888|NCT01101022|144631906|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|13.5||||0.0003|TWO_SIDED|95.0|6.3|20.7|||ANCOVA|||Bother/Concern||20.7|6.3|0.0003
72550889|NCT01101022|144631906|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|7.8||||0.0302|TWO_SIDED|95.0|0.8|14.9|||ANCOVA|||Relationships/Communication||14.9|0.8|0.0302
72550890|NCT01101022|144631907|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.9||||0.0016|TWO_SIDED|95.0|-7.8|-1.9|||ANCOVA|||Global Executive Composite||-1.9|-7.8|0.0016
72550891|NCT01101022|144631907|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.1||||0.0355|TWO_SIDED|95.0|-6.0|-0.2|||ANCOVA|||Behavioral Regulation Index||-0.2|-6.0|0.0355
72550892|NCT01101022|144631907|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.7||||0.0003|TWO_SIDED|95.0|-8.7|-2.7|||ANCOVA|||Metacognition Index||-2.7|-8.7|0.0003
72550893|NCT01101022|144631908|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-8.4||||0.0002|TWO_SIDED|95.0|-12.7|-4.0|||ANCOVA|||Behavioral Regulation Index||-4.0|-12.7|0.0002
72550894|NCT01101022|144631908|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-11.6|||<|0.0001|TWO_SIDED|95.0|-16.3|-7.0|||ANCOVA|||Metacognition Index||-7.0|-16.3|<0.0001
72550895|NCT01101022|144631909|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-8.3||||0.0001|TWO_SIDED|95.0|-12.6|-4.1|||ANCOVA|||Inhibit||-4.1|-12.6|0.0001
72550896|NCT01101022|144631909|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.7||||0.0018|TWO_SIDED|95.0|-10.8|-2.5|||ANCOVA|||Shift||-2.5|-10.8|0.0018
72550897|NCT01101022|144631909|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.2||||0.0056|TWO_SIDED|95.0|-8.8|-1.5|||ANCOVA|||Emotional control||-1.5|-8.8|0.0056
72550898|NCT01101022|144631909|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-8.2||||0.0001|TWO_SIDED|95.0|-12.3|-4.1|||ANCOVA|||Sef-monitor||-4.1|-12.3|0.0001
72550899|NCT01101022|144631909|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-9.3|||<|0.0001|TWO_SIDED|95.0|-13.2|-5.4|||ANCOVA|||Initiate||-5.4|-13.2|<0.0001
72550900|NCT01101022|144631909|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-11.3|||<|0.0001|TWO_SIDED|95.0|-16.0|-6.6|||ANCOVA|||Working memory||-6.6|-16.0|<0.0001
72550901|NCT01101022|144631909|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-10.9|||<|0.0001|TWO_SIDED|95.0|-15.4|-6.4|||ANCOVA|||Plan/Organize||-6.4|-15.4|<0.0001
72550902|NCT01101022|144631909|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-9.3||||0.0001|TWO_SIDED|95.0|-14.0|-4.7|||ANCOVA|||Task monitor||-4.7|-14.0|0.0001
72550903|NCT01101022|144631909|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-8.9|||<|0.0001|TWO_SIDED|95.0|-12.5|-5.3|||ANCOVA|||Organization of materials||-5.3|-12.5|<0.0001
72550904|NCT01101022|144631910|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.4||||0.0048|TWO_SIDED|95.0|-7.4|-1.4|||ANCOVA|||Inhibit||-1.4|-7.4|0.0048
72550905|NCT01101022|144631910|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.8||||0.0045|TWO_SIDED|95.0|-8.0|-1.5|||ANCOVA|||Shift||-1.5|-8.0|0.0045
72550906|NCT01101022|144631910|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.3||||0.3605|TWO_SIDED|95.0|-4.0|1.5|||ANCOVA|||Emotional control||1.5|-4.0|0.3605
72583590|NCT03349060|144698360|SUPERIORITY||Difference in LS mean|-2.3|||<|0.0001|TWO_SIDED|95.0|-3.0|-1.6|||Mixed Models Analysis|||MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-1.6|-3.0|<0.0001
72583591|NCT03349060|144698361|SUPERIORITY|||||||0.0071||||||P-value was controlled by randomization strata.|Log Rank|||||||0.0071
72583592|NCT03349060|144698361|SUPERIORITY||||||<|0.0001||||||P-value was controlled by randomization strata.|Log Rank|||||||<0.0001
72412994|NCT01910519|144334530|OTHER|||||||0.0411|||||||ANOVA|||Correlation of vaccine-induced blood transcription modules (BTMs) M58-B cell development/activation at day 1 with MN titers at day 42||||0.0411
72550907|NCT01101022|144631910|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.2||||0.1468|TWO_SIDED|95.0|-5.1|0.8|||ANCOVA|||Self-monitor||0.8|-5.1|0.1468
72550908|NCT01101022|144631910|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.5||||0.0002|TWO_SIDED|95.0|-8.3|-2.7|||ANCOVA|||Initiate||-2.7|-8.3|0.0002
72550909|NCT01101022|144631910|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.3||||0.0004|TWO_SIDED|95.0|-9.8|-2.9|||ANCOVA|||Working memory||-2.9|-9.8|0.0004
72583593|NCT03349060|144698362|SUPERIORITY||Difference in Percentage|6.5||||0.0869|TWO_SIDED|95.0|-0.3|13.3||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||13.3|-0.3|0.0869
72583594|NCT03349060|144698362|SUPERIORITY||Difference in Percentage|20.3||||0.0001|TWO_SIDED|95.0|12.0|28.6||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||28.6|12.0|0.0001
72583595|NCT03349060|144698362|SUPERIORITY||Difference in Percentage|13.1||||0.0259|TWO_SIDED|95.0|2.6|23.6||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||23.6|2.6|0.0259
72583596|NCT03349060|144698362|SUPERIORITY||Difference in Percentage|33.0|||<|0.0001|TWO_SIDED|95.0|21.7|44.2||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||44.2|21.7|<0.0001
72583597|NCT03349060|144698362|SUPERIORITY||Difference in Percentage|25.0||||0.0001|TWO_SIDED|95.0|14.2|35.8||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||35.8|14.2|0.0001
72583598|NCT03349060|144698362|SUPERIORITY||Difference in Percentage|44.6|||<|0.0001|TWO_SIDED|95.0|33.6|55.6||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||55.6|33.6|<0.0001
72583599|NCT03349060|144698363|SUPERIORITY||Difference in Percentage|3.9||||0.0802|TWO_SIDED|95.0|-0.7|8.5||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||8.5|-0.7|0.0802
72583600|NCT03349060|144698363|SUPERIORITY||Difference in Percentage|9.8||||0.0045|TWO_SIDED|95.0|4.0|15.7||P-value was adjusted by randomization strata (baseline disease severity and age category)|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||15.7|4.0|0.0045
72583601|NCT03349060|144698363|SUPERIORITY||Difference in Percentage|5.2||||0.1888|TWO_SIDED|95.0|-1.9|12.4||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||12.4|-1.9|0.1888
72550910|NCT01101022|144631910|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.9||||0.0015|TWO_SIDED|95.0|-7.9|-1.9|||ANCOVA|||Plan/Organize||-1.9|-7.9|0.0015
72583602|NCT03349060|144698363|SUPERIORITY||Difference in Percentage|21.7|||<|0.0001|TWO_SIDED|95.0|13.0|30.5||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||30.5|13.0|<0.0001
72583603|NCT03349060|144698363|SUPERIORITY||Difference in Percentage|13.8||||0.0071|TWO_SIDED|95.0|5.2|22.4||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||22.4|5.2|0.0071
72412995|NCT01910519|144334530|OTHER|||||||0.0067|||||||ANOVA|||Correlation of vaccine-induced blood transcription modules (BTMs) M114.0-TBA at day 1 with MN titers at day 42||||0.0067
72412996|NCT04266028|144334531|OTHER|No statistical analyses were performed.|no statistical analyses were performed|0.0|||||TWO_SIDED|||||No statistical analyses were performed||||No statistical analyses were performed.|No statistical analyses were performed.|||
72550911|NCT01101022|144631910|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.3||||0.0003|TWO_SIDED|95.0|-9.7|-2.9|||ANCOVA|||Task monitor||-2.9|-9.7|0.0003
72550912|NCT01101022|144631910|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.2||||0.0234|TWO_SIDED|95.0|-5.9|-0.4|||ANCOVA|||Organization of materials||-0.4|-5.9|0.0234
72550913|NCT01101022|144631911|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-11.1|||<|0.0001|TWO_SIDED|95.0|-14.9|-7.3|||ANCOVA|||||-7.3|-14.9|<0.0001
72550914|NCT01101022|144631914|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||Chi-squared|||||||<0.0001
72550915|NCT01101022|144631915|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|9.1|||<|0.0001|TWO_SIDED|95.0|5.4|12.7|||ANCOVA|||Living with ADHD||12.7|5.4|<0.0001
72550916|NCT01101022|144631915|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|10.8|||<|0.0001|TWO_SIDED|95.0|6.0|15.5|||ANCOVA|||General Well-being||15.5|6.0|<0.0001
72550917|NCT01101022|144631916|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.5||||0.0184|TWO_SIDED|95.0|0.1|1.0|||ANCOVA|||Question 1||1.0|0.1|0.0184
72550918|NCT01101022|144631916|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.6||||0.0004|TWO_SIDED|95.0|-0.9|-0.3|||ANCOVA|||Question 4||-0.3|-0.9|0.0004
72550919|NCT01101022|144631917|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.5||||0.0019|TWO_SIDED|95.0|-9.0|-2.1|||ANCOVA|||||-2.1|-9.0|0.0019
72583604|NCT03349060|144698363|SUPERIORITY||Difference in Percentage|29.3|||<|0.0001|TWO_SIDED|95.0|19.8|38.7||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||38.7|19.8|<0.0001
72550920|NCT01101022|144631918|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.1||||0.0017|TWO_SIDED|95.0|-8.2|-1.9|||ANCOVA|||Inattention/Memory Problems||-1.9|-8.2|0.0017
72550921|NCT01101022|144631918|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.1||||0.0174|TWO_SIDED|95.0|-7.5|-0.7|||ANCOVA|||Hyperactivity/Restlessness||-0.7|-7.5|0.0174
72550922|NCT01101022|144631918|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.0||||0.0063|TWO_SIDED|95.0|-6.8|-1.1|||ANCOVA|||Impulsivity/Emotional Liability||-1.1|-6.8|0.0063
72550923|NCT01101022|144631918|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.4||||0.0059|TWO_SIDED|95.0|-7.5|-1.3|||ANCOVA|||Problems with Self-concept||-1.3|-7.5|0.0059
72550924|NCT01101022|144631919|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|21.0||||0.0016|TWO_SIDED|95.0|8.4|33.6|||ANCOVA|||Life Productivity||33.6|8.4|0.0016
72550925|NCT01101022|144631919|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|12.1||||0.0242|TWO_SIDED|95.0|1.6|22.5|||ANCOVA|||Psychological Health||22.5|1.6|0.0242
72550926|NCT01101022|144631919|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|12.5||||0.0038|TWO_SIDED|95.0|4.2|20.8|||ANCOVA|||Life Outlook||20.8|4.2|0.0038
72550927|NCT01101022|144631919|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|7.3||||0.1752|TWO_SIDED|95.0|-3.4|18.0|||ANCOVA|||Relationships||18.0|-3.4|0.1752
72550928|NCT01101022|144631919|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|14.7||||0.0015|TWO_SIDED|95.0|5.9|23.6|||ANCOVA|||Total Score||23.6|5.9|0.0015
72550929|NCT05818137|144631966|OTHER||Change from baseline estimate|-99.2|||||TWO_SIDED|95.0|-129.6|-68.4|||||The change from baseline estimate and associated 95% confidence interval (CI) based on the Hodges-Lehmann method.|||-68.4|-129.6|
72550930|NCT05818137|144631969|OTHER||Change from baseline estimate|41.8|||||TWO_SIDED|95.0|27.8|55.5|||||The change from baseline estimate and associated 95% confidence interval (CI) based on the Hodges-Lehmann method.|||55.5|27.8|
72550931|NCT05818137|144631971|OTHER||Change from baseline estimate|-48.5|||||TWO_SIDED|95.0|-77.0|-24.8|||||The change from baseline estimate and associated 95% confidence interval (CI) based on the Hodges-Lehmann method.|||-24.8|-77.0|
72550932|NCT02532764|144631984|SUPERIORITY||Difference vs placebo|12.91|STANDARD_ERROR_OF_MEAN|6.53||0.0592|TWO_SIDED|95.0|-0.54|26.35||p-values are presented for Day 33.|Mixed Models Analysis|||A mixed-model analysis was performed with repeated time measures on the change from baseline CFQ-R RSS as outcome variable and including treatment, baseline CFQ-R RSS value, time and interaction between time and treatment as covariates.||26.35|-0.54|0.0592
72550933|NCT02532764|144631984|SUPERIORITY||difference vs placebo|19.13|STANDARD_ERROR_OF_MEAN|6.56||0.0074|TWO_SIDED|95.0|5.62|32.64||p-values are presented for Day 33|Mixed Models Analysis|||A mixed-model analysis was performed with repeated time measures on the change from baseline CFQ-R RSS as outcome variable and including treatment, baseline CFQ-R RSS value, time and interaction between time and treatment as covariates.||32.64|5.62|0.0074
72550934|NCT02532764|144631984|SUPERIORITY||difference vs placebo|14.24|STANDARD_ERROR_OF_MEAN|6.6||0.0408|TWO_SIDED|95.0|0.64|27.83||p-values are presented for Day 33|Mixed Models Analysis|||A mixed-model analysis was performed with repeated time measures on the change from baseline CFQ-R RSS as outcome variable and including treatment, baseline CFQ-R RSS value, time and interaction between time and treatment as covariates.||27.83|0.64|0.0408
72583605|NCT03349060|144698364|SUPERIORITY||Difference in Percentage|0.0|||||TWO_SIDED|95.0|-3.8|3.8||P-value could not be calculated since percentage of participants with event was 0.||||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||3.8|-3.8|
72550935|NCT02532764|144631984|SUPERIORITY||difference vs placebo|3.46|STANDARD_ERROR_OF_MEAN|6.87||0.6193|TWO_SIDED|95.0|-10.69|17.6||p-values are presented for Day 33|Mixed Models Analysis|||A mixed-model analysis was performed with repeated time measures on the change from baseline CFQ-R RSS as outcome variable and including treatment, baseline CFQ-R RSS value, time and interaction between time and treatment as covariates.||17.60|-10.69|0.6193
72550936|NCT02532764|144631986|SUPERIORITY||Difference vs placebo|23.17|STANDARD_ERROR_OF_MEAN|9.73||0.0321|TWO_SIDED|95.0|2.29|44.04||p-values are presented for Day 33.|Mixed Models Analysis|||A mixed-model analysis was performed with repeated time measures on the change from baseline CFQ-R RSS as outcome variable and including treatment, baseline CFQ-R RSS value, time and interaction between time and treatment as covariates.||44.04|2.29|0.0321
72550937|NCT02532764|144631986|SUPERIORITY||Difference vs placebo|27.3|STANDARD_ERROR_OF_MEAN|9.17||0.01|TWO_SIDED|95.0|7.64|46.96||p-values are presented for Day 33.|Mixed Models Analysis|||A mixed-model analysis was performed with repeated time measures on the change from baseline CFQ-R RSS as outcome variable and including treatment, baseline CFQ-R RSS value, time and interaction between time and treatment as covariates.||46.96|7.64|0.0100
72412997|NCT01812044|144334540|SUPERIORITY_OR_OTHER|||||||0.035|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|P-value based on Wilcoxon rank sum test of difference in medians between groups.||||||0.035
72412998|NCT01812044|144334540|SUPERIORITY_OR_OTHER|||||||0.189|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|P-value based on Wilcoxon rank sum test of difference in medians between groups.||||||0.189
72412999|NCT01812044|144334540|SUPERIORITY_OR_OTHER|||||||0.298|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|P-value based on Wilcoxon rank sum test of difference in medians between groups.||||||0.298
72413000|NCT04401579|144334599|SUPERIORITY||Cox Proportional Hazard|1.15||||0.047|TWO_SIDED|95.0|1.0|1.31|||Log Rank|||||1.31|1.00|0.047
72413001|NCT04401579|144334615|SUPERIORITY||Risk Difference (RD)|-6.0|||||TWO_SIDED|95.0|-12.0|0.0||||||||0|-12|
72413002|NCT04401579|144334616|SUPERIORITY||Risk Difference (RD)|-5.0|||||TWO_SIDED|95.0|-10.0|0.0||||||||0|-10|
72413003|NCT04401579|144334626|SUPERIORITY||Odds Ratio (OR)|1.26||||0.44|TWO_SIDED|95.0|1.01|1.57|||Regression, Logistic|||||1.57|1.01|0.44
72583606|NCT03349060|144698364|SUPERIORITY||Difference in Percentage|0.0|||||TWO_SIDED|95.0|-3.8|3.8||P-value could not be calculated since percentage of participants with event was 0.||||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||3.8|-3.8|
72583607|NCT03349060|144698364|SUPERIORITY||Difference in Percentage|0.0|||||TWO_SIDED|95.0|-3.9|3.9||P-value could not be calculated since percentage of participants with event was 0.||||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||3.9|-3.9|
72413004|NCT04401579|144334636|SUPERIORITY||Cox Proportional Hazard|1.21||||0.002|TWO_SIDED|95.0|1.06|1.39|||Log Rank|||||1.39|1.06|0.002
72413005|NCT04401579|144334637|SUPERIORITY||Cox Proportional Hazard|1.2||||0.005|TWO_SIDED|95.0|1.05|1.38|||Log Rank|||||1.38|1.05|0.005
72413006|NCT04401579|144334638|SUPERIORITY||Cox Proportional Hazard|1.24||||0.003|TWO_SIDED|95.0|1.07|1.44|||Log Rank|||||1.44|1.07|0.003
72413007|NCT04401579|144334641|SUPERIORITY||Cox Proportional Hazard|1.11|||||TWO_SIDED|95.0|0.73|1.68||||||This analysis is for Asian participants.||1.68|0.73|
72413008|NCT04401579|144334641|SUPERIORITY||Cox Proportional Hazard|1.06|||||TWO_SIDED|95.0|0.75|1.5||||||This analysis is for Black or African American participants.||1.50|0.75|
72413009|NCT04401579|144334641|SUPERIORITY||Cox Proportional Hazard|1.13|||||TWO_SIDED|95.0|0.93|1.37||||||This analysis is for White participants.||1.37|0.93|
72413010|NCT04401579|144334641|SUPERIORITY||Cox Proportional Hazard|1.34|||||TWO_SIDED|95.0|1.03|1.74||||||This analysis is for Race of Other participants.||1.74|1.03|
72413011|NCT04401579|144334642|SUPERIORITY||Cox Proportional Hazard|1.31|||||TWO_SIDED|95.0|1.08|1.6||||||This analysis is for Not Hispanic or Latino participants||1.60|1.08|
72413012|NCT04401579|144334642|SUPERIORITY||Cox Proportional Hazard|1.08|||||TWO_SIDED|95.0|0.89|1.31||||||This analysis is for Hispanic or Latino participants.||1.31|0.89|
72413013|NCT04401579|144334643|SUPERIORITY||Cox Proportional Hazard|1.23|||||TWO_SIDED|95.0|1.04|1.46||||||This analysis is for Male participants.||1.46|1.04|
72413014|NCT04401579|144334643|SUPERIORITY||Cox Proportional Hazard|1.06|||||TWO_SIDED|95.0|0.85|1.32||||||This analysis is for Female participants.||1.32|0.85|
72413015|NCT03521635|144334651|OTHER||Adjusted mean difference|0.7|STANDARD_ERROR_OF_MEAN|1.68||0.688|TWO_SIDED|95.0|-2.7|4.0|||REML-based repeated measures approach|Restricted maximum likelihood (REML) - based repeated measures approach was applied.|Mean difference was calculated as Pramipexole Sustained Release minus Pramipexole immediate Release|Mean changes from baseline of PDSS-2 score were analysed using a restricted maximum likelihood (REML) - based repeated measures approach. Analyses included the fixed, categorical effects of treatment, visit in the maintenance period, and treatment-by-visit interaction, and the continuous, fixed covariates of baseline and baseline-by-visit interaction.||4.0|-2.7|0.688
72413016|NCT03521635|144334652|OTHER||Adjusted mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.51||0.69|TWO_SIDED|95.0|-1.2|0.8|||REML-based repeated measures approach|Restricted maximum likelihood (REML) - based repeated measures approach was applied.|Mean difference was calculated as Pramipexole Sustained Release minus Pramipexole immediate Release.|Mean changes from baseline of NHQ score by patients were analysed using a restricted maximum likelihood (REML) - based repeated measures approach. Analyses included the fixed, categorical effects of treatment, visit in the maintenance period, and treatment-by-visit interaction, and the continuous, fixed covariates of baseline and baseline-by-visit interaction.||0.8|-1.2|0.690
72413017|NCT03521635|144334652|OTHER||Adjusted mean difference|-0.8|STANDARD_ERROR_OF_MEAN|0.91||0.376|TWO_SIDED|95.0|-2.7|1.1|||REML-based repeated measures approach|Restricted maximum likelihood (REML) - based repeated measures approach was applied.|Mean difference was calculated as Pramipexole Sustained Release minus Pramipexole immediate Release.|Mean changes from baseline of NHQ score by caregivers were analysed using a restricted maximum likelihood (REML) - based repeated measures approach. Analyses included the fixed, categorical effects of treatment, visit in the maintenance period, and treatment-by-visit interaction, and the continuous, fixed covariates of baseline and baseline-by-visit interaction.||1.1|-2.7|0.376
72413018|NCT03521635|144334653|OTHER||Adjusted mean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.66||0.333|TWO_SIDED|95.0|-1.9|0.7|||REML-based repeated measures approach|Restricted maximum likelihood (REML) - based repeated measures approach was applied.|Mean difference was calculated as Pramipexole Sustained Release minus Pramipexole immediate Release.|Mean changes from baseline of SCOPA-Sleep night-time sleep score were analysed using a restricted maximum likelihood (REML) - based repeated measures approach. Analyses included the fixed, categorical effects of treatment, visit in the maintenance period, and treatment-by-visit interaction, and the continuous, fixed covariates of baseline and baseline-by-visit interaction.||0.7|-1.9|0.333
72421536|NCT01181726|144354219|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|99.33|||||TWO_SIDED|90.0|92.21|107.0|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||107.00|92.21|
72583608|NCT03349060|144698364|SUPERIORITY||Difference in Percentage|6.5||||0.0234|TWO_SIDED|95.0|1.3|11.7||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||11.7|1.3|0.0234
72583609|NCT03349060|144698364|SUPERIORITY||Difference in Percentage|4.6||||0.0592|TWO_SIDED|95.0|-0.3|9.5||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||9.5|-0.3|0.0592
72583610|NCT03349060|144698364|SUPERIORITY||Difference in Percentage|11.7||||0.0022|TWO_SIDED|95.0|5.5|17.9||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||17.9|5.5|0.0022
72583611|NCT03349060|144698364|SUPERIORITY||Difference in Percentage|7.0||||0.019|TWO_SIDED|95.0|1.7|12.3||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||12.3|1.7|0.0190
72583612|NCT03349060|144698364|SUPERIORITY||Difference in Percentage|13.1||||0.001|TWO_SIDED|95.0|6.7|19.4||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||19.4|6.7|0.0010
72583613|NCT03349060|144698365|SUPERIORITY||Difference in Percentage|24.0|||<|0.0001|TWO_SIDED|95.0|13.9|34.1||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||34.1|13.9|<0.0001
72583614|NCT03349060|144698365|SUPERIORITY||Difference in Percentage|45.1|||<|0.0001|TWO_SIDED|95.0|34.7|55.5||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||55.5|34.7|<0.0001
72583615|NCT03349060|144698365|SUPERIORITY||Difference in Percentage|33.5|||<|0.0001|TWO_SIDED|95.0|21.6|45.4||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||45.4|21.6|<0.0001
72583616|NCT03349060|144698365|SUPERIORITY||Difference in Percentage|52.7|||<|0.0001|TWO_SIDED|95.0|41.2|64.2||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||64.2|41.2|<0.0001
72583617|NCT03349060|144698365|SUPERIORITY||Difference in Percentage|34.1|||<|0.0001|TWO_SIDED|95.0|21.9|46.3||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||46.3|21.9|<0.0001
72583618|NCT03349060|144698365|SUPERIORITY||Difference in Percentage|52.9|||<|0.0001|TWO_SIDED|95.0|41.3|64.6|||Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||64.6|41.3|<0.0001
72583619|NCT03349060|144698365|SUPERIORITY||Difference in Percentage|35.3|||<|0.0001|TWO_SIDED|95.0|23.3|47.4||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||47.4|23.3|<0.0001
72583620|NCT03349060|144698365|SUPERIORITY||Difference in Percentage|53.5|||<|0.0001|TWO_SIDED|95.0|42.0|65.0||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||65.0|42.0|<0.0001
72583621|NCT03349060|144698366|SUPERIORITY||Difference in Percentage|0.6||||0.7285|TWO_SIDED|95.0|-3.9|5.2||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||5.2|-3.9|0.7285
72583622|NCT03349060|144698366|SUPERIORITY||Difference in Percentage|4.0||||0.1448|TWO_SIDED|95.0|-1.2|9.2||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||9.2|-1.2|0.1448
72550938|NCT02532764|144631986|SUPERIORITY||Difference vs placebo|20.16|STANDARD_ERROR_OF_MEAN|8.62||0.0346|TWO_SIDED|95.0|1.68|38.64||p-values are presented for Day 33.|Mixed Models Analysis|||A mixed-model analysis was performed with repeated time measures on the change from baseline CFQ-R RSS as outcome variable and including treatment, baseline CFQ-R RSS value, time and interaction between time and treatment as covariates.||38.64|1.68|0.0346
72550939|NCT02532764|144631986|SUPERIORITY||Difference vs placebo|10.84|STANDARD_ERROR_OF_MEAN|9.01||0.2485|TWO_SIDED|95.0|-8.47|30.16||p-values are presented for Day 33.|Mixed Models Analysis|||A mixed-model analysis was performed with repeated time measures on the change from baseline CFQ-R RSS as outcome variable and including treatment, baseline CFQ-R RSS value, time and interaction between time and treatment as covariates.||30.16|-8.47|0.2485
72550940|NCT02532764|144631988|SUPERIORITY||difference vs placebo|4.24|STANDARD_ERROR_OF_MEAN|3.18||0.1938|TWO_SIDED|95.0|-2.3|10.79||P-values are presented for Day 33|Mixed Models Analysis|||A mixed-model analysis was performed with repeated time measures on the change from baseline ppFEV1 as outcome variable and including treatment, baseline ppFEV1 value, time and interaction between time and treatment as covariate||10.79|-2.30|0.1938
72550941|NCT02532764|144631988|SUPERIORITY||difference vs placebo|2.75|STANDARD_ERROR_OF_MEAN|3.18||0.3943|TWO_SIDED|95.0|-3.79|9.29||P-values are presented for Day 33|Mixed Models Analysis|||A mixed-model analysis was performed with repeated time measures on the change from baseline ppFEV1 as outcome variable and including treatment, baseline ppFEV1 value, time and interaction between time and treatment as covariates.||9.29|-3.79|0.3943
72550942|NCT02532764|144631988|SUPERIORITY||difference vs placebo|0.53|STANDARD_ERROR_OF_MEAN|3.18||0.8688|TWO_SIDED|95.0|-6.01|7.07||P-values are presented for Day 33|Mixed Models Analysis|||A mixed-model analysis was performed with repeated time measures on the change from baseline ppFEV1 as outcome variable and including treatment, baseline ppFEV1 value, time and interaction between time and treatment as covariates.||7.07|-6.01|0.8688
72550943|NCT02532764|144631988|SUPERIORITY||difference vs placebo|-0.51|STANDARD_ERROR_OF_MEAN|3.35||0.8813|TWO_SIDED|95.0|-7.41|6.39||P-values are presented for Day 33|Mixed Models Analysis|||A mixed-model analysis was performed with repeated time measures on the change from baseline ppFEV1 as outcome variable and including treatment, baseline ppFEV1 value, time and interaction between time and treatment as covariates.||6.39|-7.41|0.8813
72550944|NCT02532764|144631990|SUPERIORITY||Difference vs placebo|10.19|STANDARD_ERROR_OF_MEAN|4.22||0.0301|TWO_SIDED|95.0|1.13|19.25||P-values are presented for Day 33|Mixed Models Analysis|||||19.25|1.13|0.0301
72550945|NCT02532764|144631990|SUPERIORITY||Difference vs placebo|7.99|STANDARD_ERROR_OF_MEAN|3.91||0.0601|TWO_SIDED|95.0|-0.39|16.37||P-values are presented for Day 33|Mixed Models Analysis|||||16.37|-0.39|0.0601
72550946|NCT02532764|144631990|SUPERIORITY||Difference vs placebo|3.5|STANDARD_ERROR_OF_MEAN|3.69||0.358|TWO_SIDED|95.0|-4.4|11.41||P-values are presented for Day 33|Mixed Models Analysis|||||11.41|-4.40|0.3580
72550947|NCT02532764|144631990|SUPERIORITY||Difference vs placebo|3.21|STANDARD_ERROR_OF_MEAN|3.89||0.4224|TWO_SIDED|95.0|-5.13|11.55||P-values are presented for Day 33|Mixed Models Analysis|||||11.55|-5.13|0.4224
72550948|NCT01604850|144632001|SUPERIORITY_OR_OTHER||Proportion difference|-22.4|||<|0.001|TWO_SIDED|95.0|-34.4|-10.3||P-value is from the Cochran-Mantel-Haenszel (CMH) test stratified by the randomization stratification factor (ie, presence/absence of cirrhosis, genotype 2 or 3).|Cochran-Mantel-Haenszel||The difference in proportions between treatment groups and associated 95% confidence interval (CI) are calculated based on stratum-adjusted Mantel-Haenszel proportions.|A sample size of 100 subjects in each group would provide over 97% power to detect at least 20% improvement in SVR12 rate from the assumed null rate of 25% using 2-sided exact 1-sample binomial test at significance level of 0.025.||-10.3|-34.4|< 0.001
72550949|NCT00771537|144632012|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.69|STANDARD_ERROR_OF_MEAN|0.17||0.05|TWO_SIDED|95.0|0.5|0.96|||Regression, Logistic||Women in the 1-sided message group accepted testing at a lower rate (79.4%) than those in the control group (87.4%).|||.96|.50|0.05
72550950|NCT00771537|144632012|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.75|STANDARD_ERROR_OF_MEAN|0.17||0.1|TWO_SIDED|95.0|0.54|1.04|||Regression, Logistic||Women in the 2-sided trivial group were no different in their acceptance rate of HIV testing (81.3%) than women in the control group (87.4%).|||1.04|.54|.10
72550951|NCT00771537|144632012|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.92|STANDARD_ERROR_OF_MEAN|0.176||0.63|TWO_SIDED|95.0|0.65|1.3|||Regression, Logistic||Women in the 2-sided major group were no different in rates of accepting HIV testing (83.9%) than women in the control group (87.4%)|||1.30|.65|.63
72550952|NCT00771537|144632013|SUPERIORITY_OR_OTHER||Marginal Means|2.49|STANDARD_ERROR_OF_MEAN|0.037|<|0.6|TWO_SIDED|95.0|2.42|2.56|||ANOVA|Degrees of freedom = (1,978)|There was no significant effect for the 1-sided message compared to the control group on Willingness to Participate in an HIV vaccine clinical trial.|One-way Analysis of Variance||2.56|2.42|<.60
72550953|NCT00771537|144632013|SUPERIORITY_OR_OTHER||Marginal Means|2.51|STANDARD_ERROR_OF_MEAN|0.036|<|0.25|TWO_SIDED|95.0|2.44|2.58|||ANOVA|degrees of freedom = (1,1028)|There was no significant effect for the 2-sided trivial message compared to the control group on Willingness to Participate in an HIV vaccine clinical trial.|One-Way Analysis of Variance||2.58|2.44|<.25
72550954|NCT00771537|144632013|SUPERIORITY_OR_OTHER||Marginal Means|2.47|STANDARD_ERROR_OF_MEAN|0.036|<|0.91|TWO_SIDED|95.0|2.4|2.54|||ANOVA||There was no significant effect for the 2-sided major message compared to the control group on Willingness to Participate in an HIV vaccine clinical trial.|One-Way Analysis of Variance||2.54|2.40|<.91
72550955|NCT04099888|144632015|SUPERIORITY||||||||TWO_SIDED|95.0|||||||||The HR was estimated using an unstratified cox-proportional hazards model using the Efron approach for handling ties (Efron 1977), together with the associated 95% confidence intervals (CI) for the HR based on the Wald method. The effect of treatment is summarized by the hazard ratio (HR) together with its corresponding 95% Wald CI for the mITT population. No p-value will be reported.|||
72552808|NCT01686438|144636636|NON_INFERIORITY|The mean change in ISI score from baseline in Veterans receiving CBT-I by video teleconferencing will be no more than 1.67 smaller than the reference treatment, i.e., Veterans receiving in-person CBT-I.|Mean Difference (Net)|-2.03|STANDARD_DEVIATION|1.33||0.138|TWO_SIDED|95.0|-4.63|1.57|||t-test, 1 sided|||||1.57|-4.63|0.138
72552809|NCT02601560|144636657|SUPERIORITY_OR_OTHER|||||||0.095|||||||ANCOVA|||||||0.095
72552810|NCT02601560|144636657|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANCOVA|||||||<0.001
72552811|NCT02601560|144636657|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANCOVA|||||||<0.001
72413019|NCT03521635|144334653|OTHER||Adjusted mean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.29||0.374|TWO_SIDED|95.0|-0.8|0.3|||REML-based repeated measures approach|Restricted maximum likelihood (REML) - based repeated measures approach was applied.|Mean difference was calculated as Pramipexole Sustained Release minus Pramipexole immediate Release.|Mean changes from baseline of SCOPA-Sleep overall night sleep score were analysed using a restricted maximum likelihood (REML) - based repeated measures approach. Analyses included the fixed, categorical effects of treatment, visit in the maintenance period, and treatment-by-visit interaction, and the continuous, fixed covariates of baseline and baseline-by-visit interaction.||0.3|-0.8|0.374
72413020|NCT03521635|144334653|OTHER||Adjusted mean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.49||0.352|TWO_SIDED|95.0|-1.4|0.5|||REML-based repeated measures approach|Restricted maximum likelihood (REML) - based repeated measures approach was applied.|Mean difference was calculated as Pramipexole Sustained Release minus Pramipexole immediate Release.|Mean changes from baseline of SCOPA-Sleep daytime sleepiness score were analysed using a restricted maximum likelihood (REML) - based repeated measures approach. Analyses included the fixed, categorical effects of treatment, visit in the maintenance period, and treatment-by-visit interaction, and the continuous, fixed covariates of baseline and baseline-by-visit interaction.||0.5|-1.4|0.352
72550956|NCT04099888|144632016|SUPERIORITY||||||||TWO_SIDED|95.0||||||||OS was analyzed using the modified intent-to-treat (mITT) analysis set, which included all randomized participants who received at least 1 dose of study treatment and had a RECIST assessment at baseline. Kaplan Meier Curve (KM) analysis of OS was completed for the mITT population, but the number of events was too small to draw any conclusions.|The HR was estimated using an unstratified cox-proportional hazards model using the Efron approach for handling ties (Efron 1977), together with the associated 95% confidence intervals (CI) for the HR based on the Wald method. The effect of treatment is summarized by the hazard ratio (HR) together with its corresponding 95% Wald CI for the mITT population. No p-value will be reported.|||
72550957|NCT04099888|144632017|SUPERIORITY|||||||||||||||||BOR is summarized by randomized treatment group using the mITT analysis set.|The BOR is the best response recorded from the start of the treatment until disease progression or until the last evaluable assessment in the absence of progression. If a patient received subsequent anti-cancer therapy prior to progression, then BOR was calculated up to the point of starting the anti-cancer therapy.|||
72550958|NCT04099888|144632018|SUPERIORITY||||||||TWO_SIDED|95.0|||||||||The ORR is calculated as the proportion of patients who have at least one visit response with a complete response (CR) or partial response (PR). Objective responses do not require confirmation in a randomized study. Data obtained up until progression, or last evaluable assessment in the absence of progression, will be included in the analysis of ORR. Data obtained up until progression or subsequent therapy, or last evaluable assessment in the absence of progression or subsequent therapy, will be included in the analysis of ORR.|||
72550959|NCT04099888|144632019|SUPERIORITY|||||||||||||||||The DoR was calculated only for those with a documented response of CR or PR and is defined as the time from the date of first documented tumor response until the first date of documented disease progression or death, whichever is earlier.|DoR is listed only. In Arm A, the duration of response was 169 days in 1 participant before radiological progression was seen. In the other 2 participants in Arm A, the events were censored at 260 and 264 days, respectively. In Arm B, the duration of response was 85 days in 1 participant before radiological progression was seen. In the other 2 participants in Arm B, the events were censored at 1 day due to the early termination of the study.|||
72550960|NCT04099888|144632020|SUPERIORITY||||||||TWO_SIDED|95.0||||||||DCR is reported and includes any patient with a best response of stable disease, PR or CR.|The DCR and associated exact 95% CI is summarized for the mITT population. This was repeated for DCR-6, defined as the proportion of patients with CR, PR or SD at 6 months (recorded at least 24 weeks (+/-1 week) after randomization of study treatment and prior to any PD event).|||
72550961|NCT04099888|144632021|SUPERIORITY|||||||||||||||||Change in tumor size in percentage was summarized for the subset of patients in the mITT analysis set who had measurable disease at baseline.|Tumor size is defined as the sum of the longest diameters (SoDs) of the RECIST 1.1 target lesions. Change in tumor size is defined as the best overall percentage change in tumor size from baseline. Percentage change in tumor size was determined for patients with measurable disease at baseline and was derived at each visit by the percentage change in the SoDs of target lesions compared to baseline.|||
72550962|NCT04099888|144632022|SUPERIORITY||||||||||||||||||Safety, including the incidence and characteristics of biliary/loco-regional tumour-related events leading to hospitalisation and/or interventions, will be summarised descriptively.|||
72583623|NCT03349060|144698366|SUPERIORITY||Difference in Percentage|3.9||||0.2576|TWO_SIDED|95.0|-2.6|10.5||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||10.5|-2.6|0.2576
72583624|NCT03349060|144698366|SUPERIORITY||Difference in Percentage|20.4||||0.0001|TWO_SIDED|95.0|12.0|28.9||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||28.9|12.0|0.0001
72583625|NCT03349060|144698366|SUPERIORITY||Difference in Percentage|9.0||||0.0423|TWO_SIDED|95.0|1.3|16.8|||Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||16.8|1.3|0.0423
72583626|NCT03349060|144698366|SUPERIORITY||Difference in Percentage|28.0|||<|0.0001|TWO_SIDED|95.0|18.7|37.2||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||37.2|18.7|<0.0001
72583627|NCT03349060|144698366|SUPERIORITY||Difference in Percentage|13.3||||0.0066|TWO_SIDED|95.0|5.4|21.2||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||21.2|5.4|0.0066
72550963|NCT04099888|144632023|SUPERIORITY||||||||||||||||||Safety events leading to hospitalisation and/or interventions, will be summarised descriptively.|||
72550964|NCT04099888|144632027|SUPERIORITY||||||||||||||||||As this study was terminated early, a reduced statistical analysis was conducted, and the HRQoL analyses were not conducted.|||
72550965|NCT04538170|144632028|SUPERIORITY|||||||0.013||||||threshold for statistical significance|Fisher Exact|||Preliminary work showed that approximately 25% of patients report phantom pain after orchidectomy. A difference of 20% between the GAC and ORC groups was considered relevant. Power was set to 80% and the significance level to 5%, resulting in a minimum of 40 women to be recruited, which was fulfilled.||||0.013
72550966|NCT00637299|144632031|SUPERIORITY_OR_OTHER||||||<|0.01||95.0|||||t-test, 1 sided|||||||<0.01
72550967|NCT00637299|144632032|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||t-test, 1 sided|||||||<0.05
72550968|NCT00445003|144632050|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.6|||<|0.001|TWO_SIDED|95.0|2.2|9.0||adjusted for baseline visual acuity, number of planned panretinal photocoagulation sittings, and correlation between two study eyes|ANCOVA||adjusted for multiple comparison|||9.0|2.2|<.001
72550969|NCT00445003|144632050|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.7|||<|0.001|TWO_SIDED|95.0|3.2|10.1||adjusted for baseline visual acuity, number of planned panretinal photocoagulation sittings, and correlation between two study eyes|ANCOVA||adjusted for multiple comparisons|||10.1|3.2|<.001
72550970|NCT00445003|144632052|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-35.0|||<|0.01|TWO_SIDED|95.0|-64.0|-6.0||Adjusted for baseline optical coherence tomography retinal thickness and visual acuity, number of planned panretinal photocoagulation sittings, and correlation between 2 study eyes|ANCOVA||adjusted for multiple comparisons|||-6|-64|<.01
72550971|NCT00445003|144632052|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-100.0|||<|0.001|TWO_SIDED|95.0|-128.0|-71.0||adjusted for baseline optical coherence tomography retinal thickness and visual acuity, number of planned panretinal photocoagulation sittings, and correlation between 2 study eyes|ANCOVA||adjusted for multiple comparisons|||-71|-128|<.001
72550972|NCT00445003|144632054|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.9||||0.44|TWO_SIDED|95.0|-3.7|7.5||Adjusted for baseline visual acuity, number of planned panretinal photocoagulation sittings, and correlation between 2 study eyes|ANCOVA||adjusted for multiple comparisons|||7.5|-3.7|0.44
72550973|NCT00445003|144632054|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.2||||0.63|TWO_SIDED|95.0|-4.4|6.8||Adjusted for baseline visual acuity, number of planned panretinal photocoagulation sittings, and correlation between 2 study eyes|ANCOVA||adjusted for multiple comparisons|||6.8|-4.4|0.63
72550974|NCT00445003|144632057|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6||||0.001|TWO_SIDED|95.0|-1.0|-0.2||adjusted for baseline retinal volume, optical coherence tomography retinal thickness and visual acuity, number of planned panretinal photocoagulation sittings, and correlation between 2 study eyes|ANCOVA||adjusted for multiple comparisons|||-0.2|-1.0|0.001
72550975|NCT00445003|144632057|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.7|||<|0.001|TWO_SIDED|95.0|-2.1|-1.3||adjusted for baseline retinal volume, optical coherence tomography retinal thickness and visual acuity, number of planned panretinal photocoagulation sittings, and correlation between 2 study eyes|ANCOVA||adjusted for multiple comparisons|||-1.3|-2.1|<.001
72550976|NCT00864097|144632072|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) Mean Difference|-0.42|STANDARD_ERROR_OF_MEAN|0.2||0.039|TWO_SIDED|95.0|-0.81|-0.02|||ANCOVA|||LS means were estimated from the corresponding analysis of covariance (ANCOVA) model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.||-0.02|-0.81|0.039
72550977|NCT00864097|144632072|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.52|STANDARD_ERROR_OF_MEAN|0.2||0.011|TWO_SIDED|95.0|-0.91|-0.12|||ANCOVA|||LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.||-0.12|-0.91|0.011
72550978|NCT00864097|144632072|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.57|STANDARD_ERROR_OF_MEAN|0.2||0.005|TWO_SIDED|95.0|-0.97|-0.17|||ANCOVA|||LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.||-0.17|-0.97|0.005
72550979|NCT00864097|144632073|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.51|STANDARD_ERROR_OF_MEAN|0.2||0.01|TWO_SIDED|95.0|-0.91|-0.12|||ANCOVA|||LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.||-0.12|-0.91|0.010
72552812|NCT02601560|144636657|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANCOVA|||||||<0.001
72552813|NCT02601560|144636657|SUPERIORITY_OR_OTHER|||||||0.44|||||||ANCOVA|||||||0.440
72552814|NCT02601560|144636657|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANCOVA|||||||<0.001
72552815|NCT00855738|144636693|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||McNemar|||Month 3: p-value versus baseline.||||<0.0001
72552816|NCT00855738|144636693|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||McNemar|||Month 6: p-value versus baseline.||||<0.0001
72552817|NCT00855738|144636694|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||McNemar|||Month 3 \>=25% reduction: p-value versus baseline.||||<0.0001
72552818|NCT00855738|144636694|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||McNemar|||Month 3 \>=75% reduction: p-value versus baseline.||||<0.0001
72552819|NCT00855738|144636694|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||McNemar|||Month 6: \>=25% reduction: p-value versus baseline.||||<0.0001
72552820|NCT00855738|144636694|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||McNemar|||Month 6: \>=75% reduction: p-value versus baseline.||||<0.0001
72552821|NCT00855738|144636695|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0039|TWO_SIDED||||||McNemar|||Month 3: p-value versus baseline.||||0.0039
72552822|NCT00855738|144636695|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||McNemar|||Month 6: p-value versus baseline.||||<0.0001
72552823|NCT00855738|144636696|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||Wilcoxon Signed Rank Test|||||||<0.0001
72583628|NCT03349060|144698366|SUPERIORITY||Difference in Percentage|33.4|||<|0.0001|TWO_SIDED|95.0|24.3|42.5||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||42.5|24.3|<0.0001
72583629|NCT03349060|144698367|SUPERIORITY||Difference in Percentage|0.0|||||TWO_SIDED|95.0|-3.8|3.8||P-value could not be calculated since percentage of participants with events was 0.||||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||3.8|-3.8|
72583630|NCT03349060|144698367|SUPERIORITY||Difference in Percentage|0.0|||||TWO_SIDED|95.0|-3.8|3.8||P-value could not be calculated since percentage of participants with events was 0.||||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||3.8|-3.8|
72583631|NCT03349060|144698367|SUPERIORITY||Difference in Percentage|0.0|||||TWO_SIDED|95.0|-3.9|3.9||P-value could not be calculated since percentage of participants with events was 0.||||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||3.9|-3.9|
72583632|NCT03349060|144698367|SUPERIORITY||Difference in Percentage|6.5||||0.0234|TWO_SIDED|95.0|1.3|11.7||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||11.7|1.3|0.0234
72583633|NCT03349060|144698367|SUPERIORITY||Difference in Percentage|4.6||||0.0604|TWO_SIDED|95.0|-0.3|9.5||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||9.5|-0.3|0.0604
72583634|NCT03349060|144698367|SUPERIORITY||Difference in Percentage|11.7||||0.0022|TWO_SIDED|95.0|5.5|17.9||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||17.9|5.5|0.0022
72583635|NCT03349060|144698367|SUPERIORITY||Difference in Percentage|6.4||||0.0255|TWO_SIDED|95.0|1.2|11.6||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||11.6|1.2|0.0255
72583636|NCT03349060|144698367|SUPERIORITY||Difference in Percentage|13.1||||0.001|TWO_SIDED|95.0|6.7|19.4|||Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||19.4|6.7|0.0010
72583637|NCT03349060|144698368|SUPERIORITY||Difference in LS mean|-5.8|||<|0.0001|TWO_SIDED|95.0|-8.2|-3.3|||Mixed Models Analysis|||Change at Week 2: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-3.3|-8.2|<0.0001
72583638|NCT03349060|144698368|SUPERIORITY||Difference in LS mean|-10.6|||<|0.0001|TWO_SIDED|95.0|-13.0|-8.1|||Mixed Models Analysis|||Change at Week 2: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-8.1|-13.0|<0.0001
72583639|NCT03349060|144698368|SUPERIORITY||Difference in LS mean|-7.9|||<|0.0001|TWO_SIDED|95.0|-10.7|-5.0|||Mixed Models Analysis|||Change at Week 4: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-5.0|-10.7|<0.0001
72583640|NCT03349060|144698368|SUPERIORITY||Difference in LS mean|-12.7|||<|0.0001|TWO_SIDED|95.0|-15.6|-9.9|||Mixed Models Analysis|||Change at Week 4: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-9.9|-15.6|<0.0001
72583641|NCT03349060|144698368|SUPERIORITY||Difference in LS mean|-8.5|||<|0.0001|TWO_SIDED|95.0|-11.6|-5.5|||Mixed Models Analysis|||Change at Week 8: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-5.5|-11.6|<0.0001
72583642|NCT03349060|144698368|SUPERIORITY||Difference in LS mean|-13.5|||<|0.0001|TWO_SIDED|95.0|-16.5|-10.4|||Mixed Models Analysis|||Change at Week 8: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-10.4|-16.5|<0.0001
72583643|NCT03349060|144698368|SUPERIORITY||Difference in LS mean|-8.3|||<|0.0001|TWO_SIDED|95.0|-11.6|-5.1|||Mixed Models Analysis|||Change at Week 12: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-5.1|-11.6|<0.0001
72583644|NCT03349060|144698368|SUPERIORITY||Difference in LS mean|-14.0|||<|0.0001|TWO_SIDED|95.0|-17.3|-10.8|||Mixed Models Analysis|||Change at Week 12: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-10.8|-17.3|<0.0001
72583645|NCT03349060|144698369|SUPERIORITY||Difference in LS mean|-7.8||||0.0004|TWO_SIDED|95.0|-12.1|-3.5|||Mixed Models Analysis|||Change at Week 2: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-3.5|-12.1|0.0004
72413021|NCT03521635|144334654|OTHER||Adjusted mean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.26||0.259|TWO_SIDED|95.0|-0.8|0.2|||REML-based repeated measures approach|Restricted maximum likelihood (REML) - based repeated measures approach was applied.|Mean difference was calculated as Pramipexole Sustained Release minus Pramipexole immediate Release.|Mean changes from baseline of EMO sore were analysed using a restricted maximum likelihood (REML) - based repeated measures approach. Analyses included the fixed, categorical effects of treatment, visit in the maintenance period, and treatment-by-visit interaction, and the continuous, fixed covariates of baseline and baseline-by-visit interaction.||0.2|-0.8|0.259
72413022|NCT03521635|144334655|OTHER||Odds Ratio (OR)|0.96||||0.9373|TWO_SIDED|95.0|0.36|2.54|||Regression, Logistic||The odds ratio (OR) between Pramipexole Sustained Release and Pramipexole Immediate Release groups.|Logistic regression analyses for responder rate at week 18 of PDSS-2 score \<18 were performed with treatment and baseline as the independent variables.||2.54|0.36|0.9373
72413023|NCT03521635|144334656|OTHER||Odds Ratio (OR)|2.24||||0.1611|TWO_SIDED|95.0|0.73|7.49|||Regression, Logistic||The odds ratio (OR) between Pramipexole Sustained Release and Pramipexole Immediate Release groups.|Logistic regression analyses for responder rate at week 18 of EMO score were performed with treatment and baseline as the independent variables.||7.49|0.73|0.1611
72413024|NCT03521635|144334657|OTHER||Adjusted mean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.87||0.517|TWO_SIDED|95.0|-2.3|1.2|||REML-based repeated measures approach|Restricted maximum likelihood (REML) - based repeated measures approach was applied.|Mean difference was calculated as Pramipexole Sustained Release minus Pramipexole immediate Release.|Mean changes from baseline of PDQ-8 score were analysed using a restricted maximum likelihood (REML) - based repeated measures approach. Analyses included the fixed, categorical effects of treatment, visit in the maintenance period, and treatment-by-visit interaction, and the continuous, fixed covariates of baseline and baseline-by-visit interaction.||1.2|-2.3|0.517
72413025|NCT03521635|144334658|OTHER||Odds Ratio (OR)|3.44||||0.2374|TWO_SIDED|95.0|0.57|36.85|||Regression, Logistic||The odds ratio (OR) between Pramipexole Sustained Release and Pramipexole Immediate Release groups.|Logistic regression analyses for responder rate at week 18 of CGI-I were performed with treatment as the independent variable.||36.85|0.57|0.2374
72413026|NCT03521635|144334659|OTHER||Odds Ratio (OR)|3.44||||0.2374|TWO_SIDED|95.0|0.57|36.85|||Regression, Logistic||The odds ratio (OR) between Pramipexole Sustained Release and Pramipexole Immediate Release groups.|Logistic regression analyses for responder rate at week 18 of PGI-I were performed with treatment as the independent variable.||36.85|0.57|0.2374
72550980|NCT00864097|144632073|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.63|STANDARD_ERROR_OF_MEAN|0.2||0.002|TWO_SIDED|95.0|-1.03|-0.23|||ANCOVA|||LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.||-0.23|-1.03|0.002
72550981|NCT00864097|144632073|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|-1.1|-0.3|||ANCOVA|||LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.||-0.30|-1.10|<0.001
72550982|NCT00864097|144632074|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.08||0.022|TWO_SIDED|95.0|-0.32|-0.03|||ANCOVA|||LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.||-0.03|-0.32|0.022
72583646|NCT03349060|144698369|SUPERIORITY||Difference in LS mean|-14.8|||<|0.0001|TWO_SIDED|95.0|-19.0|-10.5|||Mixed Models Analysis|||Change at Week 2: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-10.5|-19.0|<0.0001
72413027|NCT03521635|144334660|OTHER||Adjusted mean difference|0.2|STANDARD_ERROR_OF_MEAN|0.79||0.82|TWO_SIDED|95.0|-1.4|1.7|||REML-based repeated measures approach|Restricted maximum likelihood (REML) - based repeated measures approach was applied.|Mean difference was calculated as Pramipexole Sustained Release minus Pramipexole immediate Release.|Mean changes from baseline of ESS score were analysed using a restricted maximum likelihood (REML) - based repeated measures approach. Analyses included the fixed, categorical effects of treatment, visit in the maintenance period, and treatment-by-visit interaction, and the continuous, fixed covariates of baseline and baseline-by-visit interaction.||1.7|-1.4|0.820
72413028|NCT01153633|144334668|SUPERIORITY_OR_OTHER|||||||0.2317||95.0||||F-test (2-sided), ANCOVA with baseline target ulcer size as covariate|F-test|||||||0.2317
72413029|NCT01153633|144334672|SUPERIORITY_OR_OTHER|||||||0.4905||95.0|||||Fisher Exact|||||||0.4905
72413030|NCT01153633|144334673|SUPERIORITY_OR_OTHER|||||||0.9945||95.0||||F-test (2-sided), ANCOVA with baseline target ulcer size as covariate|F-test|||||||0.9945
72413031|NCT00071487|144334674|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.1||||0.3677|TWO_SIDED|95.0|-19.4|7.2||P-value was not adjusted for multiple testing.|t-test, 2 sided|||Missing data was handled by using a last observation carried forward (LOCF) imputation. If patient required a protocol-prohibited medication, the SELENA SLEDAI score of the last visit prior to the use of the prohibited medication was used.||7.2|-19.4|0.3677
72413032|NCT00071487|144334674|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.9||||0.4244|TWO_SIDED|95.0|-8.7|20.6||P-value was not adjusted for multiple testing.|t-test, 2 sided|||Missing data was handled by using LOCF imputation. If patient required a protocol-prohibited medication, the SELENA SLEDAI score of the last visit prior to the use of the prohibited medication was used.||20.6|-8.7|0.4244
72583647|NCT03349060|144698369|SUPERIORITY||Difference in LS mean|-11.7|||<|0.0001|TWO_SIDED|95.0|-16.6|-6.9|||Mixed Models Analysis|||Change at Week 4: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-6.9|-16.6|<0.0001
72413033|NCT00071487|144334674|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.5||||0.3296|TWO_SIDED|95.0|-19.6|6.6||P-value was not adjusted for multiple testing.|t-test, 2 sided|||Missing data was handled by using LOCF imputation. If patient required a protocol-prohibited medication, the SELENA SLEDAI score of the last visit prior to the use of the prohibited medication was used.||6.6|-19.6|0.3296
72550983|NCT00864097|144632074|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.08||0.02|TWO_SIDED|95.0|-0.33|-0.03|||ANCOVA|||LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.||-0.03|-0.33|0.020
72550984|NCT00864097|144632074|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.24|STANDARD_ERROR_OF_MEAN|0.08||0.002|TWO_SIDED|95.0|-0.4|-0.09|||ANCOVA|||LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.||-0.09|-0.40|0.002
72550985|NCT00864097|144632075|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.17||0.957|TWO_SIDED|95.0|-0.32|0.34|||ANCOVA|||At Week 2: LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.||0.34|-0.32|0.957
72550986|NCT00864097|144632075|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.02|STANDARD_ERROR_OF_MEAN|0.17||0.899|TWO_SIDED|95.0|-0.31|0.35|||ANCOVA|||At Week 2: LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.||0.35|-0.31|0.899
72550987|NCT00864097|144632075|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.39|STANDARD_ERROR_OF_MEAN|0.17||0.022|TWO_SIDED|95.0|0.06|0.72|||ANCOVA|||At Week 2: LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.||0.72|0.06|0.022
72550988|NCT00864097|144632075|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.35|STANDARD_ERROR_OF_MEAN|0.18||0.052|TWO_SIDED|95.0|-0.7|0.0|||ANCOVA|||At Week 4: LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.||0.00|-0.70|0.052
72550989|NCT00864097|144632075|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.69|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|95.0|-1.05|-0.34|||ANCOVA|||At Week 4: LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.||-0.34|-1.05|<0.001
72550990|NCT00864097|144632075|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.48|STANDARD_ERROR_OF_MEAN|0.18||0.008|TWO_SIDED|95.0|-0.84|-0.13|||ANCOVA|||At Week 4: LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.||-0.13|-0.84|0.008
72550991|NCT00864097|144632075|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.35|STANDARD_ERROR_OF_MEAN|0.19||0.058|TWO_SIDED|95.0|-0.72|0.01|||ANCOVA|||At Week 8: LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.||0.01|-0.72|0.058
72550992|NCT00864097|144632075|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.69|STANDARD_ERROR_OF_MEAN|0.19|<|0.001|TWO_SIDED|95.0|-1.05|-0.32|||ANCOVA|||At Week 8: LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.||-0.32|-1.05|<0.001
72550993|NCT00864097|144632075|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.75|STANDARD_ERROR_OF_MEAN|0.19|<|0.001|TWO_SIDED|95.0|-1.12|-0.38|||ANCOVA|||At Week 8: LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.||-0.38|-1.12|<0.001
72550994|NCT00864097|144632075|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.53|STANDARD_ERROR_OF_MEAN|0.19||0.007|TWO_SIDED|95.0|-0.91|-0.15|||ANCOVA|||At Week 12: LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.||-0.15|-0.91|0.007
72583648|NCT03349060|144698369|SUPERIORITY||Difference in LS mean|-18.5|||<|0.0001|TWO_SIDED|95.0|-23.4|-13.6|||Mixed Models Analysis|||Change at Week 4: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-13.6|-23.4|<0.0001
72583649|NCT03349060|144698369|SUPERIORITY||Difference in LS mean|-14.3|||<|0.0001|TWO_SIDED|95.0|-19.7|-9.0|||Mixed Models Analysis|||Change at Week 8: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-9.0|-19.7|<0.0001
72550995|NCT00864097|144632075|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|-1.18|-0.41|||ANCOVA|||At Week 12: LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.||-0.41|-1.18|<0.001
72550996|NCT00864097|144632075|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.66|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|-1.05|-0.28|||ANCOVA|||At Week 12: LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.||-0.28|-1.05|<0.001
72550997|NCT00864097|144632076|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.05|STANDARD_ERROR_OF_MEAN|0.15||0.754|TWO_SIDED|95.0|-0.25|0.35|||ANCOVA|||At Week 2: LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.||0.35|-0.25|0.754
72583650|NCT03349060|144698369|SUPERIORITY||Difference in LS mean|-22.6|||<|0.0001|TWO_SIDED|95.0|-28.0|-17.3|||Mixed Models Analysis|||Change at Week 8: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-17.3|-28.0|<0.0001
72550998|NCT00864097|144632076|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.16||0.706|TWO_SIDED|95.0|-0.36|0.25|||ANCOVA|||At Week 2: LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.||0.25|-0.36|0.706
72550999|NCT00864097|144632076|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.17|STANDARD_ERROR_OF_MEAN|0.16||0.266|TWO_SIDED|95.0|-0.13|0.48|||ANCOVA|||At Week 2: LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.||0.48|-0.13|0.266
72551000|NCT00864097|144632076|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.23|STANDARD_ERROR_OF_MEAN|0.18||0.195|TWO_SIDED|95.0|-0.58|0.12|||ANCOVA|||At Week 4: LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.||0.12|-0.58|0.195
72551001|NCT00864097|144632076|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.72|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|95.0|-1.07|-0.36|||ANCOVA|||At Week 4: LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.||-0.36|-1.07|<0.001
72552824|NCT00855738|144636707|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1797|TWO_SIDED||||||t-test, 2 sided|||Depression domain: P-value vs baseline.||||0.1797
72552825|NCT00855738|144636707|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0433|TWO_SIDED||||||t-test, 2 sided|||Anxiety domain: P-value vs baseline.||||0.0433
72552826|NCT00855738|144636708|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8284|TWO_SIDED||||||t-test, 2 sided|||Energy: p-value versus baseline.||||0.8284
72552827|NCT00855738|144636708|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6299|TWO_SIDED||||||t-test, 2 sided|||Emotions (mood): p-value versus baseline.||||0.6299
72552828|NCT00855738|144636708|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6162|TWO_SIDED||||||t-test, 2 sided|||Daily activities: p-value versus baseline.||||0.6162
72552829|NCT00855738|144636708|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5609|TWO_SIDED||||||t-test, 2 sided|||Mental function: p-value versus baseline.||||0.5609
72552830|NCT00855738|144636708|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4635|TWO_SIDED||||||t-test, 2 sided|||Medication effects (physical/ mental): p-value versus baseline.||||0.4635
72552831|NCT00855738|144636708|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||t-test, 2 sided|||Worry about seizures (impact of seizures): p-value versus baseline.||||<0.0001
72551002|NCT00864097|144632076|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.43|STANDARD_ERROR_OF_MEAN|0.18||0.019|TWO_SIDED|95.0|-0.78|-0.07|||ANCOVA|||At Week 4: LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.||-0.07|-0.78|0.019
72551003|NCT00864097|144632076|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.28|STANDARD_ERROR_OF_MEAN|0.18||0.126|TWO_SIDED|95.0|-0.64|0.08|||ANCOVA|||At Week 8: LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.||0.08|-0.64|0.126
72551004|NCT00864097|144632076|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.73|STANDARD_ERROR_OF_MEAN|0.19|<|0.001|TWO_SIDED|95.0|-1.1|-0.37|||ANCOVA|||At Week 8: LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.||-0.37|-1.10|<0.001
72551005|NCT00864097|144632076|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.62|STANDARD_ERROR_OF_MEAN|0.19||0.001|TWO_SIDED|95.0|-0.98|-0.25|||ANCOVA|||At Week 8: LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.||-0.25|-0.98|0.001
72551006|NCT00864097|144632076|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.52|STANDARD_ERROR_OF_MEAN|0.19||0.007|TWO_SIDED|95.0|-0.9|-0.15|||ANCOVA|||At Week 12: LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.||-0.15|-0.90|0.007
72551007|NCT00864097|144632076|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.82|STANDARD_ERROR_OF_MEAN|0.19|<|0.001|TWO_SIDED|95.0|-1.21|-0.44|||ANCOVA|||At Week 12: LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.||-0.44|-1.21|<0.001
72551008|NCT00864097|144632076|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.64|STANDARD_ERROR_OF_MEAN|0.2||0.001|TWO_SIDED|95.0|-1.02|-0.25|||ANCOVA|||At Week 12: LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.||-0.25|-1.02|0.001
72551009|NCT00864097|144632077|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.07||0.2|TWO_SIDED|95.0|-0.22|0.05|||ANCOVA|||At Week 2: LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.||0.05|-0.22|0.200
72551010|NCT00864097|144632077|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.07||0.754|TWO_SIDED|95.0|-0.15|0.11|||ANCOVA|||At Week 2: LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.||0.11|-0.15|0.754
72551011|NCT00864097|144632077|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.05|STANDARD_ERROR_OF_MEAN|0.07||0.449|TWO_SIDED|95.0|-0.08|0.18|||ANCOVA|||At Week 2: LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.||0.18|-0.08|0.449
72551012|NCT00864097|144632077|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.07||0.062|TWO_SIDED|95.0|-0.27|0.01|||ANCOVA|||At Week 4: LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.||0.01|-0.27|0.062
72551013|NCT00864097|144632077|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.07||0.002|TWO_SIDED|95.0|-0.36|-0.08|||ANCOVA|||At Week 4: LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.||-0.08|-0.36|0.002
72551014|NCT00864097|144632077|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.07||0.026|TWO_SIDED|95.0|-0.3|-0.02|||ANCOVA|||At Week 4: LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.||-0.02|-0.30|0.026
72551015|NCT00864097|144632077|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.07||0.032|TWO_SIDED|95.0|-0.31|-0.01|||ANCOVA|||At Week 8: LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.||-0.01|-0.31|0.032
72551016|NCT00864097|144632077|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.33|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|95.0|-0.48|-0.19|||ANCOVA|||At Week 8: LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.||-0.19|-0.48|<0.001
72551017|NCT00864097|144632077|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.31|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-0.45|-0.16|||ANCOVA|||At Week 8: LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.||-0.16|-0.45|<0.001
72551018|NCT00864097|144632077|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.07||0.038|TWO_SIDED|95.0|-0.3|-0.01|||ANCOVA|||At Week 12: LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.||-0.01|-0.30|0.038
72551019|NCT00864097|144632077|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.07||0.003|TWO_SIDED|95.0|-0.37|-0.07|||ANCOVA|||At Week 12: LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.||-0.07|-0.37|0.003
72551020|NCT00864097|144632077|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.08||0.016|TWO_SIDED|95.0|-0.33|-0.03|||ANCOVA|||At Week 12: LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.||-0.03|-0.33|0.016
72551021|NCT02334722|144632101|SUPERIORITY||Median Difference (Final Values)|-2.5||||0.7824|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.7824
72551022|NCT03661528|144632110|OTHER||Percentage proportion difference|13.4||||0.0032|TWO_SIDED|95.0|4.6|22.2|||Cochran-Mantel-Haenszel|||||22.2|4.6|0.0032
72551023|NCT03661528|144632111|OTHER||Difference in least squares mean|-185.99|||<|0.0001|TWO_SIDED|95.0|-199.93|-172.05|||ANCOVA|Analysis presented for ANCOVA based on ranks.||||-172.05|-199.93|<0.0001
72551024|NCT00686959|144632154|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.98||||0.831|TWO_SIDED|95.0|0.79|1.2|||Log Rank|||||1.20|0.79|0.831
72551025|NCT00686959|144632155|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.86||||0.13|TWO_SIDED|95.0|0.71|1.04|||Log Rank|||||1.04|0.71|0.130
72551026|NCT00686959|144632156|SUPERIORITY_OR_OTHER|||||||0.458|TWO_SIDED||||||Log Rank|||||||0.458
72551027|NCT00686959|144632159|SUPERIORITY_OR_OTHER|||||||0.132|TWO_SIDED||||||Fisher Exact|||Relapsed within the radiation treatment field||||0.132
72551028|NCT00686959|144632159|SUPERIORITY_OR_OTHER|||||||0.337|TWO_SIDED||||||Fisher Exact|||Relapsed inside thorax, outside of radiation field||||0.337
72551029|NCT00686959|144632159|SUPERIORITY_OR_OTHER|||||||0.457|TWO_SIDED||||||Fisher Exact|||Relapsed distant disease||||0.457
72551030|NCT00686959|144632160|SUPERIORITY_OR_OTHER|||||||0.15|TWO_SIDED||||||Fisher Exact|||||||0.150
72551031|NCT01212874|144632170|SUPERIORITY_OR_OTHER|||||||0.21|||||||t-test, 2 sided|||||||0.21
72551032|NCT01212874|144632171|SUPERIORITY_OR_OTHER|||||||0.04|||||||t-test, 2 sided|||||||0.04
72551033|NCT03553823|144632188|SUPERIORITY||Difference secukinumab vs guselkumab|20.0||||0.1715|TWO_SIDED|95.0|-13.3|50.3|||Fisher Exact|The statistical model was the Fisher's exact test for the difference in proportions.||"Proportion of subjects whose plaque achieves clear or almost clear status (TCS = 0-2)"||50.3|-13.3|0.1715
72551034|NCT00615069|144632237|SUPERIORITY_OR_OTHER|||||||0.003|TWO_SIDED|95.0|||||Log Rank|||Log-rank test of freedom from major adverse events through 1 year, 31 mm GORE EXCLUDER® Test Subjects vs historical open surgical control Subjects.||||0.003
72551035|NCT00615069|144632238|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.241|||||TWO_SIDED|95.0|0.428|3.603||||||Estimation of Hazard ratio of the 31 mm GORE EXCLUDER® Test Subjects vs original GORE EXCLUDER® AAA Endoprosthesis Subjects (original PMA subjects) using Cox Regression, not a powered analysis.||3.603|0.428|
72551036|NCT00259012|144632269|SUPERIORITY_OR_OTHER|||||||0.087|||||||t-test, 2 sided|paired||Within group comparison between steady state and baseline||||0.087
72551037|NCT00259012|144632269|SUPERIORITY_OR_OTHER|||||||0.019|||||||t-test, 2 sided|paired||Within group comparison between steady state and baseline||||0.019
72551038|NCT00259012|144632270|SUPERIORITY_OR_OTHER|||||||0.255|||||||t-test, 2 sided|paired||Within group comparison between steady state and baseline||||0.255
72551039|NCT00259012|144632270|SUPERIORITY_OR_OTHER|||||||0.031|||||||t-test, 2 sided|paired||Within group comparison between steady state and baseline.||||0.031
72551040|NCT00259012|144632271|SUPERIORITY_OR_OTHER|||||||0.099|||||||t-test, 2 sided|||Within group comparison between steady state and baseline||||0.099
72551041|NCT00259012|144632271|SUPERIORITY_OR_OTHER|||||||0.016|||||||t-test, 2 sided|||Within group comparison between steady state and baseline||||0.016
72551042|NCT00259012|144632272|SUPERIORITY_OR_OTHER|||||||0.347|||||||t-test, 2 sided|||Within group comparison between steady state and baseline||||0.347
72551043|NCT00259012|144632272|SUPERIORITY_OR_OTHER|||||||0.012|||||||t-test, 2 sided|||Within group comparison between steady state and baseline||||0.012
72551044|NCT00259012|144632273|SUPERIORITY_OR_OTHER|||||||0.339|||||||t-test, 2 sided|||Within group comparison between steady state and baseline||||0.339
72551045|NCT00259012|144632273|SUPERIORITY_OR_OTHER|||||||0.003|||||||t-test, 2 sided|||Within group comparison between steady state and baseline||||0.003
72551046|NCT00259012|144632274|SUPERIORITY_OR_OTHER|||||||0.982|||||||t-test, 2 sided|||Within group comparison between steady state and baseline||||0.982
72551047|NCT00259012|144632274|SUPERIORITY_OR_OTHER|||||||0.534|||||||t-test, 2 sided|||Within group comparison between steady state and baseline||||0.534
72551048|NCT00259012|144632275|SUPERIORITY_OR_OTHER|||||||0.166|||||||t-test, 2 sided|||Within group comparison between steady state and baseline||||0.166
72551049|NCT00259012|144632275|SUPERIORITY_OR_OTHER|||||||0.119|||||||t-test, 2 sided|||Within group comparison between steady state and baseline||||0.119
72551050|NCT00259012|144632276|SUPERIORITY_OR_OTHER|||||||0.387|||||||t-test, 2 sided|||Within group comparison between steady state and baseline||||0.387
72551051|NCT00259012|144632276|SUPERIORITY_OR_OTHER|||||||0.021|||||||t-test, 2 sided|||Within group comparison between steady state and baseline||||0.021
72551052|NCT03117569|144632309|NON_INFERIORITY|A total of 375 participants (2:1 randomisation) were planned for enrolment and evaluation as ITT population. Under the assumption that SVR12 rate would be 96% in both arms, the study had 80% power to show non-inferiority of the simplified monitoring strategy with a lower confidence bound for SVR12 in the simplified monitoring arm greater than 90% or with a lower confidence bound for the difference (simplified arm minus standard arm) in SVR12 greater than -6%.|Difference in Percentage of Participants|-3.2|||<|0.05|TWO_SIDED|95.0|-8.2|1.8|||t-test, 2 sided|||||1.8|-8.2|<0.05
72551053|NCT01312922|144632354|SUPERIORITY||Odds Ratio (OR)|0.987||||1|TWO_SIDED|95.0|0.456|2.14|||Fisher Exact|||||2.140|0.456|1.000
72551054|NCT01312922|144632354|SUPERIORITY||Odds Ratio (OR)|1.031||||1|TWO_SIDED|95.0|0.476|2.233|||Fisher Exact|||||2.233|0.476|1.000
72551055|NCT02227121|144632357|SUPERIORITY_OR_OTHER||Percentage|92.86|||||ONE_SIDED|95.0|70.3|||||||Null Hypothesis: Percentage of Subjects with Successful VF Termination ≤ 65% Alternative Hypothesis: Percentage of Subjects with Successful VF Termination \> 65%|||70.3|
72551056|NCT03929367|144632358|OTHER|Modeling of change of plasma oxytocin concentration over time using nonlinear canonical compartment model.|Bayesian information criterion|2.0|||||TWO_SIDED|||||||||||||
72551057|NCT03929367|144632369|SUPERIORITY|Light touch detection frequency was compared over time in comparison to baseline using a one way analysis of variance for repeated measures. A power analysis was not performed for this secondary outcome measure.||||||0.89||||||No effect|ANOVA|||||||.89
72551058|NCT03929367|144632376|SUPERIORITY|Sustained heat score at the end of each 5 minute session was compared to baseline across time using a one-way analysis of variance for repeated measures. Power analysis was not performed for this secondary outcome measure.||||||0.014|||||||ANOVA|||||||0.014
72551059|NCT00515203|144632400|SUPERIORITY_OR_OTHER|||||||0.0019|||||||Cochran-Mantel-Haenszel|||||||0.0019
72551060|NCT00515203|144632401|SUPERIORITY_OR_OTHER|||||||0.3651|||||||Cochran-Mantel-Haenszel|||||||0.3651
72551061|NCT00515203|144632402|SUPERIORITY_OR_OTHER|||||||0.0008|||||||Fisher Exact|||||||0.0008
72551062|NCT00515203|144632403|SUPERIORITY_OR_OTHER|||||||0.0008|||||||Fisher Exact|||||||0.0008
72551063|NCT00515203|144632404|SUPERIORITY_OR_OTHER|||||||0.2098|||||||Fisher Exact|||||||0.2098
72551064|NCT01706536|144632406|SUPERIORITY||Least Squares Mean (SE)|0.1168|STANDARD_ERROR_OF_MEAN|0.04055||0.0043|TWO_SIDED|95.0|0.0369|0.1966|||Least squares mean (SE)|In order to control for Type I error rate, a gate keeping methodology was used.||A sample size of 45 subjects per treatment arm provides approximately 80% power to detect a 0.12 L treatment difference in mean change in trough FEV1 between an active arm and the placebo arm at a significance level of 0.05 using a 2-group t-test and assumes a standard deviation for change in trough FEV1 of 200. Assuming a 20% discontinuation rate, approximately 55 subjects were enrolled into each treatment arm.||0.1966|0.0369|0.0043
72552832|NCT00855738|144636708|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0258|TWO_SIDED||||||t-test, 2 sided|||Overall quality of life: p-value versus baseline.||||0.0258
72552833|NCT00855738|144636709|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7822|TWO_SIDED||||||t-test, 2 sided|||Month 3: p-value versus baseline.||||0.7822
72552834|NCT00855738|144636709|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4471|TWO_SIDED||||||t-test, 2 sided|||Month 6: p-value versus baseline.||||0.4471
72552835|NCT00855738|144636710|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2452|TWO_SIDED||||||t-test, 2 sided|||Sleep disturbance: p-value versus baseline.||||0.2452
72552836|NCT00855738|144636710|SUPERIORITY_OR_OTHER_LEGACY|||||||1|TWO_SIDED||||||t-test, 2 sided|||Snoring: p-value verus baseline.||||1.0000
72552837|NCT00855738|144636710|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4253|TWO_SIDED||||||t-test, 2 sided|||Awake short of breath: p-value versus baseline.||||0.4253
72552838|NCT00855738|144636710|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0572|TWO_SIDED||||||t-test, 2 sided|||Quantity: p-value versus baseline.||||0.0572
72552839|NCT00855738|144636710|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0625|TWO_SIDED||||||t-test, 2 sided|||Adequacy: p-value versus baseline.||||0.0625
72552840|NCT00855738|144636710|SUPERIORITY_OR_OTHER_LEGACY|||||||0.554|TWO_SIDED||||||t-test, 2 sided|||Somnolence: p-value versus baseline.||||0.5540
72552841|NCT00855738|144636710|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4204|TWO_SIDED||||||t-test, 2 sided|||Sleep problems (summary 6): p-value versus baseline.||||0.4204
72552842|NCT00855738|144636710|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4869|TWO_SIDED||||||t-test, 2 sided|||Sleep problems (summary 9): p-value versus baseline.||||0.4869
72552843|NCT00855738|144636711|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0863|TWO_SIDED||||||McNemar|||Month 6: p-value versus baseline.||||0.0863
72552844|NCT00855738|144636712|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0226|TWO_SIDED||||||t-test, 2 sided|||Number of visits to a specialist because of epilepsy: p-value versus baseline.||||0.0226
72552845|NCT00855738|144636712|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0017|TWO_SIDED||||||t-test, 2 sided|||Number of visits to the emergency room because of epilepsy: p-value versus baseline.||||0.0017
72552846|NCT00855738|144636713|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3141|TWO_SIDED||||||t-test, 2 sided|||P-value versus baseline.||||0.3141
72552847|NCT00855738|144636714|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0708|TWO_SIDED||||||t-test, 2 sided|||Cessation of usual occupation: p-value versus baseline.||||0.0708
72552848|NCT00855738|144636714|SUPERIORITY_OR_OTHER_LEGACY|||||||1|TWO_SIDED||||||t-test, 2 sided|||Requirement of informal caregiver: p-value versus baseline.||||1.0000
72552849|NCT00855738|144636714|SUPERIORITY_OR_OTHER_LEGACY|||||||1|TWO_SIDED||||||t-test, 2 sided|||Required admission to ICU: p-value versus baseline.||||1.0000
72552850|NCT02779543|144636724|EQUIVALENCE|this trial compared the 2 devices to the polysomnography, which is the gold standard|Mean value|368.3|||<|0.001|TWO_SIDED||||||ANOVA||compared to gold standard|||||<0.001
72552851|NCT02779543|144636725|EQUIVALENCE|This trial compared those 2 devices with the gold standard (polysomnography)|Mean value|13.9|||<|0.001|TWO_SIDED||||||ANOVA||compared to gold standard|||||<0.001
72552852|NCT02779543|144636726|EQUIVALENCE|This trial compared those 2 devices with the gold standard (polysomnography)|Mean value|106.0|||<|0.001|TWO_SIDED||||||ANOVA||compared to gold standard|||||<0.001
72551065|NCT01706536|144632406|SUPERIORITY||Least Squares Mean (SE)|0.1284|STANDARD_ERROR_OF_MEAN|0.04089||0.0019|TWO_SIDED|95.0|0.0479|0.2089||In order to control for Type I error rate, a gate keeping methodology was used|Least squares mean (SE)|||A sample size of 45 subjects per treatment arm provides approximately 80% power to detect a 0.12 L treatment difference in mean change in trough FEV1 between an active arm and the placebo arm at a significance level of 0.05 using a 2-group t-test and assumes a standard deviation for change in trough FEV1 of 200. Assuming a 20% discontinuation rate, approximately 55 subjects were enrolled into each treatment arm.||0.2089|0.0479|0.0019
72551066|NCT01706536|144632406|SUPERIORITY||Least Squares Mean (SE)|0.1462|STANDARD_ERROR_OF_MEAN|0.04037||0.0004|TWO_SIDED|95.0|0.0667|0.2257||in order to control for Type 1 error rate, a gate keeping methodology was used|Least squares mean (SE)|||A sample size of 45 subjects per treatment arm provides approximately 80% power to detect a 0.12 L treatment difference in mean change in trough FEV1 between an active arm and the placebo arm at a significance level of 0.05 using a 2-group t-test and assumes a standard deviation for change in trough FEV1 of 200. Assuming a 20% discontinuation rate, approximately 55 subjects were enrolled into each treatment arm.||0.2257|0.0667|0.0004
72551067|NCT01706536|144632406|SUPERIORITY||Least Squares Mean (SE)|0.177|STANDARD_ERROR_OF_MEAN|0.03953|<|0.0001|TWO_SIDED|95.0|0.0992|0.2548||in order to control for type I error rate, a gate keeping methodology was used|Least squares mean (SE)|||A sample size of 45 subjects per treatment arm provides approximately 80% power to detect a 0.12 L treatment difference in mean change in trough FEV1 between an active arm and the placebo arm at a significance level of 0.05 using a 2-group t-test and assumes a standard deviation for change in trough FEV1 of 200. Assuming a 20% discontinuation rate, approximately 55 subjects were enrolled into each treatment arm.||0.2548|0.0992|<0.0001
72551068|NCT00993187|144632427|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-0.8|||<|0.001|TWO_SIDED|95.0|-1.0|-0.6|||ANCOVA|||||-0.6|-1.0|<0.001
72551069|NCT00993187|144632430|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-23.5|||<|0.001|TWO_SIDED|95.0|-30.0|-16.9|||ANCOVA|||||-16.9|-30.0|<0.001
72551070|NCT00993187|144632431|SUPERIORITY_OR_OTHER||Difference in percent|-14.7|||<|0.001|TWO_SIDED|95.0|-23.0|-7.0|||ANCOVA|||||-7.0|-23.0|<0.001
72551071|NCT00993187|144632432|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-1.72|||<|0.001|TWO_SIDED|95.0|-2.2|-1.25|||ANCOVA|||||-1.25|-2.20|<0.001
72551072|NCT00993187|144632433|SUPERIORITY_OR_OTHER||Difference in percent|41.01|||<|0.001|TWO_SIDED|95.0|30.0|51.0|||ANCOVA|||||51.0|30.0|<0.001
72551073|NCT01108094|144632465|OTHER|||||||0.04|||||||t-test, 2 sided|||"Percent change in Ki67 tumor proliferation biomarker from baseline to 1 month, for Cohort A1 (vismodegib-naive patients, n = 8).~Paired analysis of tumors shows percent change between baseline (prior to treatment) and post-itraconazole treatment in individual patients.~% change was calculated from the difference between the mean of baseline Ki67 levels and the mean Ki67 levels after 1 month of treatment."||||0.04
72551074|NCT01108094|144632465|OTHER|||||||0.079|||||||t-test, 1 sided|||"Percent change in Ki67 tumor proliferation biomarker - baseline vs 1 month - Cohort A, vismodegib-naive (n = 8) vs control patients Unpaired analysis shows percent change between individual tumors from control patients and itraconazole treated patients.~% change was calculated from the difference between the mean of baseline Ki67 levels and the mean Ki67 levels after 1 month of treatment."||||0.079
72551075|NCT01108094|144632465|OTHER|||||||0.652|||||||t-test, 2 sided|||"Percent change in Ki67 tumor proliferation biomarker - baseline vs 1 month - control patients Paired analysis of tumors shows percent change between baseline and after 1 month in individual patients.~% change was calculated from the difference between the mean of baseline Ki67 levels and the mean Ki67 levels after 1 month."||||0.652
72551076|NCT01108094|144632466|OTHER|||||||0.028|||||||t-test, 2 sided|||"Percentage change in GLI1 messenger RNA (mRNA) expression Paired analysis of tumors shows percent change between baseline (prior to treatment) and post itraconazole treatment in individual patients.~% change was calculated from the difference between the mean of baseline Gli levels and the mean Gli level after 1 month of treatment."|Wilcoxon signed rank test|||0.028
72551077|NCT01108094|144632467|OTHER||Mean Difference (Final Values)|24.0|||||TWO_SIDED|95.0|18.2|30.0||||||Only tumors from 4 patients from cohort A (n = 42 BCCs) and all tumors from the 4 patients (n = 14 BCCs) in cohort B were observed for tumor size change. Percent change in tumor area from both cohorts (eight patients total with 57 tumors) was calculated only.||30|18.2|
72551078|NCT01108094|144632467|OTHER|||||||0.435|||||||t-test, 1 sided|||Average tumor size reductions were compared between Cohort A1 and Cohort B.||||0.435
72551079|NCT00420303|144632476|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.47||||0.029||95.0|-32.93|-2.01|||ANCOVA|Treatment groups as fixed factors, baseline value as covariate||Comparison of adjusted means||-2.01|-32.93|0.029
72551080|NCT00420303|144632477|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|10.0||||0.02||95.0|1.44|69.26|||Generalized estimating equations (GEE)|Logit link, a binomial distribution and an auto-regressive correlation structure with treatment groups, visits and their interaction as fixed factors.||||69.26|1.44|0.02
72551081|NCT00420303|144632478|SUPERIORITY_OR_OTHER|||||||0.007|||||||ANCOVA|Treatment groups, visits and their interaction as fixed factors, baseline value as a covariate and patients as a random factor.||||||0.007
72551082|NCT04455633|144632482|SUPERIORITY||LS Mean Difference|-0.67|STANDARD_ERROR_OF_MEAN|0.249||0.007|TWO_SIDED|95.0|-1.16|-0.18|||MMRM model|||Mixed model repeated measures (MMRM) model included fixed effects of treatment, visit, treatment-by-week interaction, the randomization stratum of Baseline pain severity (moderate, severe), and the Baseline ADPS score as a covariate.||-0.18|-1.16|0.007
72551083|NCT04455633|144632482|SUPERIORITY||LS Mean Difference|-0.55|STANDARD_ERROR_OF_MEAN|0.254||0.03|TWO_SIDED|95.0|-1.06|-0.05|||MMRM model|||MMRM model included fixed effects of treatment, visit, treatment-by-week interaction, the randomization stratum of Baseline pain severity (moderate, severe), and the Baseline ADPS score as a covariate.||-0.05|-1.06|0.030
72552853|NCT02779543|144636727|EQUIVALENCE|This trial compared those 2 devices with the gold standard (polysomnography)|Mean value|74.3|||<|0.001|TWO_SIDED||||||ANOVA||compared to gold standard|||||<0.001
72552854|NCT03707912|144636728|SUPERIORITY|||||||0.032|||||||Wilcoxon (Mann-Whitney)|||||||0.032
72552855|NCT03707912|144636729|SUPERIORITY|||||||0.11|||||||Wilcoxon (Mann-Whitney)|||||||0.11
72551084|NCT04455633|144632483|SUPERIORITY||Difference in Percentage of Responders|9.6||||0.091|TWO_SIDED|95.0|-1.55|20.76|||Cochran-Mantel-Haenszel|||Percentage of responders were analyzed using the Cochran-Mantel-Haenszel (CMH) test stratified by the randomization factor of Baseline severity score (moderate, severe). The 95% confidence interval (CI) are calculated using the asymptotic Wald method. Missing observations at Week 6 are imputed as nonresponses.||20.76|-1.55|0.091
72551085|NCT04455633|144632483|SUPERIORITY||Difference in Percentage of Responders|-0.8||||0.883|TWO_SIDED|95.0|-10.95|9.4|||Cochran-Mantel-Haenszel|||Percentage of responders were analyzed using the CMH test stratified by the randomization factor of Baseline severity score (moderate, severe). The 95% CI are calculated using the asymptotic Wald method. Missing observations at Week 6 are imputed as nonresponses.||9.40|-10.95|0.883
72551086|NCT04455633|144632484|SUPERIORITY||Difference in Percentage of Responders|4.8||||0.289|TWO_SIDED|95.0|-4.11|13.73|||Cochran-Mantel-Haenszel|||Percentage of responders were analyzed using the CMH test stratified by the randomization factor of Baseline severity score (moderate, severe). The 95% CI are calculated using the asymptotic Wald method. Missing observations at Week 6 are imputed as nonresponses.||13.73|-4.11|0.289
72551087|NCT04455633|144632484|SUPERIORITY||Difference in Percentage of Responders|-0.8||||0.837|TWO_SIDED|95.0|-8.85|7.16|||Cochran-Mantel-Haenszel|||Percentage of responders were analyzed using the CMH test stratified by the randomization factor of Baseline severity score (moderate, severe). The 95% CI are calculated using the asymptotic Wald method. Missing observations at Week 6 are imputed as nonresponses.||7.16|-8.85|0.837
72551088|NCT04455633|144632485|SUPERIORITY||LS Mean Difference|-0.73|STANDARD_ERROR_OF_MEAN|0.298||0.014|TWO_SIDED|95.0|-1.32|-0.15|||MMRM model|||Pain at its Worst: change from baseline was analyzed using MMRM model including fixed effects of treatment, visit, treatment-by-visit interaction, the randomization stratum of baseline pain severity (moderate, severe), and the baseline pain at its worst score as a covariate.||-0.15|-1.32|0.014
72551089|NCT04455633|144632485|SUPERIORITY||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.29||0.017|TWO_SIDED|95.0|-1.27|-0.13|||MMRM model|||Pain at its Worst: change from baseline was analyzed using MMRM model including fixed effects of treatment, visit, treatment-by-visit interaction, the randomization stratum of baseline pain severity (moderate, severe), and the baseline pain at its worst score as a covariate.||-0.13|-1.27|0.017
72551090|NCT04455633|144632485|SUPERIORITY||LS Mean Difference|-0.74|STANDARD_ERROR_OF_MEAN|0.302||0.015|TWO_SIDED|95.0|-1.33|-0.15|||MMRM model|||Pain at its Least: change from baseline was analyzed using MMRM model including fixed effects of treatment, visit, treatment-by-visit interaction, the randomization stratum of baseline pain severity (moderate, severe), and the baseline pain at its least score as a covariate.||-0.15|-1.33|0.015
72551091|NCT04455633|144632485|SUPERIORITY||LS Mean Difference|-0.69|STANDARD_ERROR_OF_MEAN|0.294||0.02|TWO_SIDED|95.0|-1.27|-0.11|||MMRM model|||Pain at its Least: change from baseline was analyzed using MMRM model including fixed effects of treatment, visit, treatment-by-visit interaction, the randomization stratum of baseline pain severity (moderate, severe), and the baseline pain at its least score as a covariate.||-0.11|-1.27|0.020
72551092|NCT04455633|144632485|SUPERIORITY||LS Mean Difference|-0.87|STANDARD_ERROR_OF_MEAN|0.309||0.005|TWO_SIDED|95.0|-1.48|-0.27|||MMRM model|||Pain Right Now: change from baseline was analyzed using MMRM model including fixed effects of treatment, visit, treatment-by-visit interaction, the randomization stratum of baseline pain severity (moderate, severe), and the baseline pain right now score as a covariate.||-0.27|-1.48|0.005
72552856|NCT03707912|144636730|SUPERIORITY|||||||0.0012|||||||Cochran-Mantel-Haenszel|||||||0.0012
72551093|NCT04455633|144632485|SUPERIORITY||LS Mean Difference|-0.48|STANDARD_ERROR_OF_MEAN|0.301||0.111|TWO_SIDED|95.0|-1.07|0.11|||MMRM model|||Pain Right Now: change from baseline was analyzed using MMRM model including fixed effects of treatment, visit, treatment-by-visit interaction, the randomization stratum of baseline pain severity (moderate, severe), and the baseline pain right now score as a covariate.||0.11|-1.07|0.111
72551094|NCT04455633|144632485|SUPERIORITY||LS Mean Difference|-0.26|STANDARD_ERROR_OF_MEAN|0.31||0.399|TWO_SIDED|95.0|-0.87|0.35|||MMRM model|||Interference score averaged Over Questions 9A - G: change from baseline was analyzed using MMRM model including fixed effects of treatment, visit, treatment-by-visit interaction, the randomization stratum of baseline pain severity (moderate, severe), and the baseline pain interference score as a covariate.||0.35|-0.87|0.399
72551095|NCT04455633|144632485|SUPERIORITY||LS Mean Difference|-0.23|STANDARD_ERROR_OF_MEAN|0.302||0.441|TWO_SIDED|95.0|-0.83|0.36|||MMRM model|||Interference score averaged Over Questions 9A - G: change from baseline was analyzed using MMRM model including fixed effects of treatment, visit, treatment-by-visit interaction, the randomization stratum of baseline pain severity (moderate, severe), and the baseline pain interference score as a covariate.||0.36|-0.83|0.441
72551096|NCT04455633|144632485|SUPERIORITY||LS Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.346||0.575|TWO_SIDED|95.0|-0.87|0.49|||MMRM model|||General Activity: change from baseline was analyzed using MMRM model including fixed effects of treatment, visit, treatment-by-visit interaction, the randomization stratum of baseline pain severity (moderate, severe), and the baseline general activity score as a covariate.||0.49|-0.87|0.575
72551097|NCT04455633|144632485|SUPERIORITY||LS Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.337||0.88|TWO_SIDED|95.0|-0.71|0.61|||MMRM model|||General Activity: change from baseline was analyzed using MMRM model including fixed effects of treatment, visit, treatment-by-visit interaction, the randomization stratum of baseline pain severity (moderate, severe), and the baseline general activity score as a covariate.||0.61|-0.71|0.880
72551098|NCT04455633|144632485|SUPERIORITY||LS Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.368||0.978|TWO_SIDED|95.0|-0.73|0.71|||MMRM model|||Mood: change from baseline was analyzed using MMRM model including fixed effects of treatment, visit, treatment-by-visit interaction, the randomization stratum of baseline pain severity (moderate, severe), and the baseline mood score as a covariate.||0.71|-0.73|0.978
72551099|NCT04455633|144632485|SUPERIORITY||LS Mean Difference|0.06|STANDARD_ERROR_OF_MEAN|0.358||0.877|TWO_SIDED|95.0|-0.65|0.76|||MMRM model|||Mood: change from baseline was analyzed using MMRM model including fixed effects of treatment, visit, treatment-by-visit interaction, the randomization stratum of baseline pain severity (moderate, severe), and the baseline mood score as a covariate.||0.76|-0.65|0.877
72551100|NCT04455633|144632485|SUPERIORITY||LS Mean Difference|-0.62|STANDARD_ERROR_OF_MEAN|0.354||0.079|TWO_SIDED|95.0|-1.32|0.07|||MMRM model|||Walking Ability: change from baseline was analyzed using MMRM model including fixed effects of treatment, visit, treatment-by-visit interaction, the randomization stratum of baseline pain severity (moderate, severe), and the baseline walking ability score as a covariate.||0.07|-1.32|0.079
72551101|NCT04455633|144632485|SUPERIORITY||LS Mean Difference|-0.48|STANDARD_ERROR_OF_MEAN|0.345||0.163|TWO_SIDED|95.0|-1.16|0.2|||MMRM model|||Walking Ability: change from baseline was analyzed using MMRM model including fixed effects of treatment, visit, treatment-by-visit interaction, the randomization stratum of baseline pain severity (moderate, severe), and the baseline walking ability score as a covariate.||0.20|-1.16|0.163
72583651|NCT03349060|144698369|SUPERIORITY||Difference in LS mean|-13.8|||<|0.0001|TWO_SIDED|95.0|-19.3|-8.2|||Mixed Models Analysis|||Change at Week 12: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-8.2|-19.3|<0.0001
72583652|NCT03349060|144698369|SUPERIORITY||Difference in LS mean|-22.0|||<|0.0001|TWO_SIDED|95.0|-27.6|-16.5|||Mixed Models Analysis|||Change at Week 12: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-16.5|-27.6|<0.0001
72583653|NCT03349060|144698370|SUPERIORITY||Difference in Percentage|1.3||||0.521|TWO_SIDED|95.0|-3.4|6.0||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||6.0|-3.4|0.5210
72583654|NCT03349060|144698370|SUPERIORITY||Difference in Percentage|4.0||||0.1416|TWO_SIDED|95.0|-1.3|9.3||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||9.3|-1.3|0.1416
72583655|NCT03349060|144698370|SUPERIORITY||Difference in Percentage|4.6||||0.2002|TWO_SIDED|95.0|-2.1|11.2||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||11.2|-2.1|0.2002
72583656|NCT03349060|144698370|SUPERIORITY||Difference in Percentage|23.6|||<|0.0001|TWO_SIDED|95.0|15.1|32.2||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||32.2|15.1|<0.0001
72583657|NCT03349060|144698370|SUPERIORITY||Difference in Percentage|9.6||||0.0434|TWO_SIDED|95.0|1.3|17.9||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||17.9|1.3|0.0434
72583658|NCT03349060|144698370|SUPERIORITY||Difference in Percentage|26.6|||<|0.0001|TWO_SIDED|95.0|17.1|36.2||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||36.2|17.1|<0.0001
72551102|NCT04455633|144632485|SUPERIORITY||LS Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.344||0.875|TWO_SIDED|95.0|-0.73|0.62|||MMRM model|||Normal Work: change from baseline was analyzed using MMRM model including fixed effects of treatment, visit, treatment-by-visit interaction, the randomization stratum of baseline pain severity (moderate, severe), and the baseline normal work score as a covariate.||0.62|-0.73|0.875
72551103|NCT04455633|144632485|SUPERIORITY||LS Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.335||0.914|TWO_SIDED|95.0|-0.69|0.62|||MMRM model|||Normal Work: change from baseline was analyzed using MMRM model including fixed effects of treatment, visit, treatment-by-visit interaction, the randomization stratum of baseline pain severity (moderate, severe), and the baseline normal work score as a covariate.||0.62|-0.69|0.914
72551104|NCT04455633|144632485|SUPERIORITY||LS Mean Difference|0.43|STANDARD_ERROR_OF_MEAN|0.351||0.219|TWO_SIDED|95.0|-0.26|1.12|||MMRM model|||Relations with Other People: change from baseline was analyzed using MMRM model including fixed effects of treatment, visit, treatment-by-visit interaction, the randomization stratum of baseline pain severity (moderate, severe), and the baseline relations with other people score as a covariate.||1.12|-0.26|0.219
72551105|NCT04455633|144632485|SUPERIORITY||LS Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|0.341||0.551|TWO_SIDED|95.0|-0.47|0.87|||MMRM model|||Relations with Other People: change from baseline was analyzed using MMRM model including fixed effects of treatment, visit, treatment-by-visit interaction, the randomization stratum of baseline pain severity (moderate, severe), and the baseline relations with other people score as a covariate.||0.87|-0.47|0.551
72551106|NCT04455633|144632485|SUPERIORITY||LS Mean Difference|-0.96|STANDARD_ERROR_OF_MEAN|0.339||0.005|TWO_SIDED|95.0|-1.63|-0.3|||MMRM model|||Sleep: change from baseline was analyzed using MMRM model including fixed effects of treatment, visit, treatment-by-visit interaction, the randomization stratum of baseline pain severity (moderate, severe), and the baseline sleep score as a covariate.||-0.30|-1.63|0.005
72551107|NCT04455633|144632485|SUPERIORITY||LS Mean Difference|-1.04|STANDARD_ERROR_OF_MEAN|0.329||0.002|TWO_SIDED|95.0|-1.68|-0.39|||MMRM model|||Sleep: change from baseline was analyzed using MMRM model including fixed effects of treatment, visit, treatment-by-visit interaction, the randomization stratum of baseline pain severity (moderate, severe), and the baseline sleep score as a covariate.||-0.39|-1.68|0.002
72551108|NCT04455633|144632485|SUPERIORITY||LS Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.361||0.955|TWO_SIDED|95.0|-0.73|0.69|||MMRM model|||Enjoyment of Life: change from baseline was analyzed using MMRM model including fixed effects of treatment, visit, treatment-by-visit interaction, the randomization stratum of baseline pain severity (moderate, severe), and the baseline enjoyment of life score as a covariate.||0.69|-0.73|0.955
72551109|NCT04455633|144632485|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.351||0.777|TWO_SIDED|95.0|-0.79|0.59|||MMRM model|||Enjoyment of Life: change from baseline was analyzed using MMRM model including fixed effects of treatment, visit, treatment-by-visit interaction, the randomization stratum of baseline pain severity (moderate, severe), and the baseline enjoyment of life score as a covariate.||0.59|-0.79|0.777
72551110|NCT04455633|144632487|SUPERIORITY||LS Mean Difference|-0.35|STANDARD_ERROR_OF_MEAN|0.163||0.031|TWO_SIDED|95.0|-0.67|-0.03|||ANOVA|||Analysis of variance (ANOVA) model was used for the analysis with treatment and the randomization stratum of baseline pain severity (moderate, severe) as fixed covariates.||-0.03|-0.67|0.031
72551111|NCT04455633|144632487|SUPERIORITY||LS Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.165||0.351|TWO_SIDED|95.0|-0.48|0.17|||ANOVA|||ANOVA model was used for the analysis with treatment and the randomization stratum of baseline pain severity (moderate, severe) as fixed covariates.||0.17|-0.48|0.351
72551112|NCT01027780|144632517|SUPERIORITY_OR_OTHER|||||||0.007||95.0||||Please note that this analysis tested the differences between groups following the intervention.|GEE|Generalized estimating equations (GEE) approach was used to assess robustness of population parameters, such as treatment effects.||||||.007
72551113|NCT01027780|144632518|SUPERIORITY_OR_OTHER|||||||0.04||95.0||||Note that this is the p value for differences between groups immediately following the intervention|GEE|Generalized estimating equations (GEE) approach was used to assess robustness of population parameters, such as treatment effects.||||||.04
72551114|NCT01027780|144632519|SUPERIORITY_OR_OTHER|||||||0.03||95.0||||Difference between groups following intervention|ANOVA|||||||.03
72551115|NCT01029353|144632544|SUPERIORITY||Risk Ratio (RR)|1.0|||||TWO_SIDED|95.0|0.87|1.14|||||RR: Initial Laparotomy over Peritoneal Drain. RR from robust Poisson regression with log link, reference cell coding, center as repeated measure. Model included treatment, baseline risk of death or NDI, and pre-op diagnosis (NEC/IP) as covariates.|A frequentist analysis. Model included treatment, baseline risk of death or NDI, and pre-operative diagnosis (Necrotizing Enterocolitis (NEC) or Isolated Intestinal Perforation (IP)) as covariates.||1.14|0.87|
72551116|NCT01029353|144632544|OTHER|||||||0.03||||||Pre-specified threshold = 0.05|Robust Poisson regression|||A frequentist analysis. Using Robust Poisson regression with log link and center as repeated measure, and effect coding, test for an interaction between treatment (Initial Laparotomy/Initial Peritoneal Drain) and pre-operative diagnosis (Necrotizing Enterocolitis (NEC) or Isolated Intestinal Perforation (IP)) as covariates. Model included treatment, baseline risk of death or NDI, pre-op diagnosis (NEC/IP), and treatment by pre-operative diagnosis as covariates.||||0.03
72551117|NCT01029353|144632544|SUPERIORITY|||||||||||||||||A Bayesian analysis. Initial Laparotomy and Initial Peritoneal Drain were compared using log-binomial regression. The SAS procedure PROC MCMC with reference cell coding was used. Center (random effect), treatment, pre-operative diagnosis, and baseline risk of death or NDI were binary covariates. Pre-operative diagnosis levels were NEC and IP. Markov chain Monte Carlo (MCMC) characteristics: three chains, 10000 tunings, 10000 burn-ins, 1000000 samples, thinning=20.|Priors for model parameters: intercept = Normal(mean=0, variance=100), baseline risk and preop diagnosis parameters = Normal(mean=0, variance=1), treatment and the interaction term = Normal(mean=0, variance=0.31416), random effect standard deviation = Half-Normal(mean=0, variance=10). The posterior median relative risk of Initial Laparotomy over Initial Drainage was 0.95, 95% credible interval of (0.82, 1.11).|||
72551118|NCT01029353|144632544|SUPERIORITY||Risk Ratio (RR)|0.97|||||TWO_SIDED|95.0|0.75|1.26|||||RR: Initial Laparotomy over Peritoneal Drain. RR from robust regression with log link, reference cell coding, center as repeated measure. Model included treatment, baseline risk of death or NDI, and pre-op diagnosis (NEC/IP) as covariate.|A frequentist analysis. Model included treatment, baseline risk of death or NDI, and pre-operative diagnosis (Necrotizing Enterocolitis (NEC) or Isolated Intestinal Perforation (IP)) covariates.||1.26|0.75|
72551119|NCT01029353|144632545|SUPERIORITY||Risk Ratio (RR)|1.0|||||TWO_SIDED|95.0|0.69|1.45|||||RR: Initial Laparotomy over Peritoneal Drain. RR from robust Poisson regression with log link, reference cell coding, center as repeated measure. Model included treatment, baseline risk of death or NDI, and pre-op diagnosis (NEC/IP) as covariates.|A frequentist analysis.||1.45|0.69|
72551120|NCT01029353|144632545|SUPERIORITY|A Bayesian analysis. Initial Laparotomy and Initial Peritoneal Drain were compared using log-binomial regression. The SAS procedure PROC MCMC with reference cell coding was used. Center (random effect), treatment, pre-operative diagnosis, and baseline risk of death or NDI were binary covariates. Pre-operative diagnosis levels were NEC and IP. Markov chain Monte Carlo (MCMC) characteristics: three chains, 10000 tunings, 10000 burn-ins, 1000000 samples, thinning=20.|||||||||||||||||Priors for model parameters: intercept = Normal(mean=0, variance=100), baseline risk and preop diagnosis parameters = Normal(mean=0, variance=1), treatment and the interaction term = Normal(mean=0, variance=0.31416), random effect standard deviation = Half-Normal(mean=0, variance=10). The posterior median relative risk of Initial Laparotomy over Initial Drainage was 0.95, 95% credible interval of (0.69, 1.30).|||
72551121|NCT01029353|144632546|SUPERIORITY||Risk Ratio (RR)|1.02|||||TWO_SIDED|95.0|0.78|1.34|||||RR: Initial Laparotomy over Peritoneal Drain. RR from robust Poisson regression with log link, reference cell coding, center as repeated measure. Model included treatment, baseline risk of death or NDI, and pre-op diagnosis (NEC/IP) as covariates.|A frequentist analysis. Estimate based on model fit using only data from study survivors.||1.34|0.78|
72551122|NCT01029353|144632546|SUPERIORITY|||||||||||||||||A Bayesian analysis among study survivors. Initial Laparotomy and Initial Peritoneal Drain were compared using log-binomial regression. The SAS procedure PROC MCMC with reference cell coding was used. Center (random effect), treatment, pre-operative diagnosis, and baseline risk of death or NDI were binary covariates. Pre-operative diagnosis levels were NEC and IP. Markov chain Monte Carlo (MCMC) characteristics: three chains, 10000 tunings, 10000 burn-ins, 1000000 samples, thinning=20.|Priors for model parameters: intercept = Normal(mean=0, variance=100), baseline risk and preop diagnosis parameters = Normal(mean=0, variance=1), treatment and the interaction term = Normal(mean=0, variance=0.31416), random effect standard deviation = Half-Normal(mean=0, variance=10). The posterior median relative risk of Initial Laparotomy over Initial Drainage was 0.99, 95% credible interval of (0.78, 1.25).|||
72551123|NCT01029353|144632547|SUPERIORITY||Risk Ratio (RR)|0.83|||||TWO_SIDED|95.0|0.66|1.06|||||RR: Initial Laparotomy over Peritoneal Drain. RR from robust Poisson regression with log link, reference cell coding, center as repeated measure. Model included treatment, baseline risk of death or NDI, and pre-op diagnosis (NEC/IP) as covariates.|A frequentist analysis.||1.06|0.66|
72551124|NCT01029353|144632547|SUPERIORITY|||||||||||||||||A Bayesian analysis. Initial Laparotomy and Initial Peritoneal Drain were compared using log-binomial regression. The SAS procedure PROC MCMC with reference cell coding was used. Center (random effect), treatment, pre-operative diagnosis, and baseline risk of death or NDI were binary covariates. Pre-operative diagnosis levels were NEC and IP. Markov chain Monte Carlo (MCMC) characteristics: three chains, 10000 tunings, 10000 burn-ins, 1000000 samples, thinning=20.|Priors for model parameters: intercept = Normal(mean=0, variance=100), baseline risk and preop diagnosis parameters = Normal(mean=0, variance=1), treatment and the interaction term = Normal(mean=0, variance=0.31416), random effect standard deviation = Half-Normal(mean=0, variance=10). The posterior median relative risk of Initial Laparotomy over Initial Drainage was 0.82, 95% credible interval of (0.65, 1.02).|||
72551125|NCT01029353|144632548|SUPERIORITY||Risk Ratio (RR)|1.03|||||TWO_SIDED|95.0|0.89|1.18|||||RR: Initial Laparotomy over Peritoneal Drain. RR from robust Poisson regression with log link, reference cell coding, center as repeated measure. Model included treatment, baseline risk of death or NDI, and pre-op diagnosis (NEC/IP) as covariates.|A frequentist analysis.||1.18|0.89|
72551126|NCT01029353|144632548|SUPERIORITY|||||||||||||||||A Bayesian analysis. Initial Laparotomy and Initial Peritoneal Drain were compared using log-binomial regression. The SAS procedure PROC MCMC with reference cell coding was used. Center (random effect), treatment, pre-operative diagnosis, and baseline risk of death or NDI were binary covariates. Pre-operative diagnosis levels were NEC and IP. Markov chain Monte Carlo (MCMC) characteristics: three chains, 10000 tunings, 10000 burn-ins, 1000000 samples, thinning=20.|Priors for model parameters: intercept = Normal(mean=0, variance=100), baseline risk and preop diagnosis parameters = Normal(mean=0, variance=1), treatment and the interaction term = Normal(mean=0, variance=0.31416), random effect standard deviation = Half-Normal(mean=0, variance=10). The posterior median relative risk of Initial Laparotomy over Initial Drainage was 0.98, 95% credible interval of (0.84, 1.15).|||
72552857|NCT03707912|144636730|OTHER|Test for assessing the homogeneity of the odds ratio in several 2 × 2 contingency tables.||||||0.98|||||||Breslow-Day test|||||||0.98
72552858|NCT03707912|144636731|SUPERIORITY|||||||0.007|||||||Wilcoxon (Mann-Whitney)|||||||0.007
72552859|NCT03707912|144636732|SUPERIORITY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
72552860|NCT03707912|144636732|OTHER|Test for assessing the homogeneity of the odds ratio in several 2 × 2 contingency tables.||||||0.75|||||||Breslow-Day test|||||||0.75
72552861|NCT03707912|144636733|SUPERIORITY|||||||0.89|||||||Wilcoxon (Mann-Whitney)|||Day 1 comparison.||||0.89
72552862|NCT03707912|144636733|SUPERIORITY|||||||0.75|||||||Wilcoxon (Mann-Whitney)|||Day 2 comparison.||||0.75
72552863|NCT03707912|144636733|SUPERIORITY|||||||0.34|||||||Wilcoxon (Mann-Whitney)|||Day 3 comparison.||||0.34
72552864|NCT03707912|144636734|SUPERIORITY|||||||0.75|||||||Fisher Exact|||||||0.75
72551127|NCT01029353|144632549|SUPERIORITY||Risk Ratio (RR)|0.92|||||TWO_SIDED|95.0|0.64|1.31|||||RR: Initial Laparotomy over Peritoneal Drain. RR from robust Poisson regression with log link, reference cell coding, center as repeated measure. Model included treatment, baseline risk of death or NDI, and pre-op diagnosis (NEC/IP) as covariates.|A frequentist analysis.||1.31|0.64|
72551128|NCT01029353|144632549|SUPERIORITY|||||||||||||||||A Bayesian analysis. Initial Laparotomy and Initial Peritoneal Drain were compared using log-binomial regression. The SAS procedure PROC MCMC with reference cell coding was used. Center (random effect), treatment, pre-operative diagnosis, and baseline risk of death or NDI were binary covariates. Pre-operative diagnosis levels were NEC and IP. Markov chain Monte Carlo (MCMC) characteristics: three chains, 10000 tunings, 10000 burn-ins, 1000000 samples, thinning=20.|Priors for model parameters: intercept = Normal(mean=0, variance=100), baseline risk and preop diagnosis parameters = Normal(mean=0, variance=1), treatment and the interaction term = Normal(mean=0, variance=0.31416), random effect standard deviation = Half-Normal(mean=0, variance=10). The posterior median relative risk of Initial Laparotomy over Initial Drainage was 0.86, 95% credible interval of (0.64, 1.16).|||
72551129|NCT01029353|144632550|SUPERIORITY||Risk Ratio (RR)|0.97|||||TWO_SIDED|95.0|0.69|1.36|||||RR: Initial Laparotomy over Peritoneal Drain. RR from robust Poisson regression with log link, reference cell coding, center as repeated measure. Model included treatment, baseline risk of death or NDI, and pre-op diagnosis (NEC/IP) as covariates.|A frequentist analysis.||1.36|0.69|
72551130|NCT01029353|144632550|SUPERIORITY|||||||||||||||||A Bayesian analysis. Initial Laparotomy and Initial Peritoneal Drain were compared using log-binomial regression. The SAS procedure PROC MCMC with reference cell coding was used. Center (random effect), treatment, pre-operative diagnosis, and baseline risk of death or NDI were binary covariates. Pre-operative diagnosis levels were NEC and IP. Markov chain Monte Carlo (MCMC) characteristics: three chains, 10000 tunings, 10000 burn-ins, 1000000 samples, thinning=20.|Priors for model parameters: intercept = Normal(mean=0, variance=100), baseline risk and preop diagnosis parameters = Normal(mean=0, variance=1), treatment and the interaction term = Normal(mean=0, variance=0.31416), random effect standard deviation = Half-Normal(mean=0, variance=10). The posterior median relative risk of Initial Laparotomy over Initial Drainage was 0.92, 95% credible interval of (0.68, 1.25).|||
72551131|NCT01029353|144632551|SUPERIORITY||Risk Ratio (RR)|0.47|||||TWO_SIDED|95.0|0.35|0.63|||||RR: Initial Laparotomy over Peritoneal Drain. RR from robust Poisson regression with log link, reference cell coding, center as repeated measure. Model included treatment, baseline risk of death or NDI, and pre-op diagnosis (NEC/IP) as covariates.|A frequentist analysis.||0.63|0.35|
72551132|NCT01029353|144632551|SUPERIORITY|||||||||||||||||A Bayesian analysis. Initial Laparotomy and Initial Peritoneal Drain were compared using log-binomial regression. The SAS procedure PROC MCMC with reference cell coding was used. Center (random effect), treatment, pre-operative diagnosis, and baseline risk of death or NDI were binary covariates. Pre-operative diagnosis levels were NEC and IP. Markov chain Monte Carlo (MCMC) characteristics: three chains, 10000 tunings, 10000 burn-ins, 1000000 samples, thinning=20.|Priors for model parameters: intercept = Normal(mean=0, variance=100), baseline risk and preop diagnosis parameters = Normal(mean=0, variance=1), treatment and the interaction term = Normal(mean=0, variance=0.31416), random effect standard deviation = Half-Normal(mean=0, variance=10). The posterior median relative risk of Initial Laparotomy over Initial Drainage was 0.51, 95% credible interval of (0.37, 0.69).|||
72551133|NCT01029353|144632552|SUPERIORITY||Risk Ratio (RR)|1.57|||||TWO_SIDED|95.0|1.04|2.36|||||RR: Initial Laparotomy over Peritoneal Drain. RR from robust Poisson regression with log link, reference cell coding, center as repeated measure. Model included treatment, baseline risk of death or NDI, and pre-op diagnosis (NEC/IP) as covariates.|A frequentist analysis.||2.36|1.04|
72551134|NCT01029353|144632552|SUPERIORITY|||||||||||||||||A Bayesian analysis. Initial Laparotomy and Initial Peritoneal Drain were compared using log-binomial regression. The SAS procedure PROC MCMC with reference cell coding was used. Center (random effect), treatment, pre-operative diagnosis, and baseline risk of death or NDI were binary covariates. Pre-operative diagnosis levels were NEC and IP. Markov chain Monte Carlo (MCMC) characteristics: three chains, 10000 tunings, 10000 burn-ins, 1000000 samples, thinning=20.|Priors for model parameters: intercept = Normal(mean=0, variance=100), baseline risk and preop diagnosis parameters = Normal(mean=0, variance=1), treatment and the interaction term = Normal(mean=0, variance=0.31416), random effect standard deviation = Half-Normal(mean=0, variance=10). The posterior median relative risk of Initial Laparotomy over Initial Drainage was 1.45, 95% credible interval of (0.92, 2.31).|||
72551135|NCT01029353|144632553|SUPERIORITY||Risk Ratio (RR)|1.58|||||TWO_SIDED|95.0|0.71|3.5|||||RR: Initial Laparotomy over Peritoneal Drain. RR from robust Poisson regression with log link, reference cell coding, center as repeated measure. Model included treatment, baseline risk of death or NDI, and pre-op diagnosis (NEC/IP) as covariates.|A frequentist analysis.||3.50|0.71|
72551136|NCT01029353|144632553|SUPERIORITY|||||||||||||||||A Bayesian analysis. Initial Laparotomy and Initial Peritoneal Drain were compared using log-binomial regression. The SAS procedure PROC MCMC with reference cell coding was used. Center (random effect), treatment, pre-operative diagnosis, and baseline risk of death or NDI were binary covariates. Pre-operative diagnosis levels were NEC and IP. Markov chain Monte Carlo (MCMC) characteristics: three chains, 10000 tunings, 10000 burn-ins, 1000000 samples, thinning=20.|Priors for model parameters: intercept = Normal(mean=0, variance=100), baseline risk and preop diagnosis parameters = Normal(mean=0, variance=1), treatment and the interaction term = Normal(mean=0, variance=0.31416), random effect standard deviation = Half-Normal(mean=0, variance=10). The posterior median relative risk of Initial Laparotomy over Initial Drainage was 1.31, 95% credible interval of (0.66, 2.62).|||
72551137|NCT01029353|144632554|SUPERIORITY|||||||||||||||||A frequentist analysis.|This analysis used model identical to other by treatment analyses for binary outcome. RR estimated from robust Poisson regression with log link, reference cell coding, center as repeated measure. RR: Initial Laparotomy over Peritoneal Drain. Model included treatment, baseline risk of death or NDI, and pre-op diagnosis (NEC/IP) as covariates. However, adjusted RR estimates could not be calculated due to the iteration limit being excessed in PROC GENMOD.|||
72551138|NCT01029353|144632554|SUPERIORITY|||||||||||||||||A Bayesian analysis. Initial Laparotomy and Initial Peritoneal Drain were compared using log-binomial regression. The SAS procedure PROC MCMC with reference cell coding was used. Center (random effect), treatment, pre-operative diagnosis, and baseline risk of death or NDI were binary covariates. Pre-operative diagnosis levels were NEC and IP. Markov chain Monte Carlo (MCMC) characteristics: three chains, 10000 tunings, 10000 burn-ins, 1000000 samples, thinning=20.|Priors for model parameters: intercept = Normal(mean=0, variance=100), baseline risk and preop diagnosis parameters = Normal(mean=0, variance=1), treatment and the interaction term = Normal(mean=0, variance=0.31416), random effect standard deviation = Half-Normal(mean=0, variance=10). The posterior median relative risk of Initial Laparotomy over Initial Drainage was 1.16, 95% credible interval of (0.50, 2.65).|||
72551139|NCT01029353|144632555|SUPERIORITY||Risk Ratio (RR)|0.86|||||TWO_SIDED|95.0|0.34|2.2|||||RR: Initial Laparotomy over Peritoneal Drain. RR from robust Poisson regression with log link, reference cell coding, center as repeated measure. Model included treatment, baseline risk of death or NDI, and pre-op diagnosis (NEC/IP) as covariates.|A frequentist analysis.||2.20|0.34|
72583659|NCT03349060|144698370|SUPERIORITY||Difference in Percentage|15.8||||0.0019|TWO_SIDED|95.0|7.5|24.0||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||24.0|7.5|0.0019
72583660|NCT03349060|144698370|SUPERIORITY||Difference in Percentage|33.3|||<|0.0001|TWO_SIDED|95.0|24.0|42.7||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||42.7|24.0|<0.0001
72583661|NCT03349060|144698371|SUPERIORITY||Difference in Percentage|10.8||||0.0151|TWO_SIDED|95.0|3.3|18.3||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||18.3|3.3|0.0151
72583662|NCT03349060|144698371|SUPERIORITY||Difference in Percentage|30.0|||<|0.0001|TWO_SIDED|95.0|21.0|39.0||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||39.0|21.0|<0.0001
72583663|NCT03349060|144698371|SUPERIORITY||Difference in Percentage|21.2||||0.001|TWO_SIDED|95.0|10.2|32.3||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||32.3|10.2|0.0010
72583664|NCT03349060|144698371|SUPERIORITY||Difference in Percentage|37.9|||<|0.0001|TWO_SIDED|95.0|26.6|49.3||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||49.3|26.6|<0.0001
72583665|NCT03349060|144698371|SUPERIORITY||Difference in Percentage|23.5||||0.0003|TWO_SIDED|95.0|12.6|34.3||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||34.3|12.6|0.0003
72583666|NCT03349060|144698371|SUPERIORITY||Difference in Percentage|41.7|||<|0.0001|TWO_SIDED|95.0|30.7|52.7||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||52.7|30.7|<0.0001
72583667|NCT03349060|144698371|SUPERIORITY||Difference in Percentage|19.6||||0.0026|TWO_SIDED|95.0|8.1|31.1||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||31.1|8.1|0.0026
72583668|NCT03349060|144698371|SUPERIORITY||Difference in Percentage|40.0|||<|0.0001|TWO_SIDED|95.0|28.3|51.7||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||51.7|28.3|<0.0001
72583669|NCT03349060|144698372|SUPERIORITY||Difference in Percentage|1.3||||0.3151|TWO_SIDED|95.0|-2.9|5.6||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||5.6|-2.9|0.3151
72583670|NCT03349060|144698372|SUPERIORITY||Difference in Percentage|6.0||||0.0292|TWO_SIDED|95.0|0.7|11.3||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||11.3|0.7|0.0292
72583671|NCT03349060|144698372|SUPERIORITY||Difference in Percentage|-0.2||||0.9402|TWO_SIDED|95.0|-5.9|5.5||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||5.5|-5.9|0.9402
72551140|NCT01029353|144632555|SUPERIORITY|||||||||||||||||A Bayesian analysis. Initial Laparotomy and Initial Peritoneal Drain were compared using log-binomial regression. The SAS procedure PROC MCMC with reference cell coding was used. Center (random effect), treatment, pre-operative diagnosis, and baseline risk of death or NDI were binary covariates. Pre-operative diagnosis levels were NEC and IP. Markov chain Monte Carlo (MCMC) characteristics: three chains, 10000 tunings, 10000 burn-ins, 1000000 samples, thinning=20.|Priors for model parameters: intercept = Normal(mean=0, variance=100), baseline risk and preop diagnosis parameters = Normal(mean=0, variance=1), treatment and the interaction term = Normal(mean=0, variance=0.31416), random effect standard deviation = Half-Normal(mean=0, variance=10). The posterior median relative risk of Initial Laparotomy over Initial Drainage was 0.93, 95% credible interval of (0.45, 1.91).|||
72551141|NCT01029353|144632556|SUPERIORITY||Risk Ratio (RR)|0.73|||||TWO_SIDED|95.0|0.37|1.42|||||RR: Initial Laparotomy over Peritoneal Drain. RR from robust Poisson regression with log link, reference cell coding, center as repeated measure. Model included treatment, baseline risk of death or NDI, and pre-op diagnosis (NEC/IP) as covariates.|A frequentist analysis.||1.42|0.37|
72551142|NCT01029353|144632556|SUPERIORITY|||||||||||||||||A Bayesian analysis. Initial Laparotomy and Initial Peritoneal Drain were compared using log-binomial regression. The SAS procedure PROC MCMC with reference cell coding was used. Center (random effect), treatment, pre-operative diagnosis, and baseline risk of death or NDI were binary covariates. Pre-operative diagnosis levels were NEC and IP. Markov chain Monte Carlo (MCMC) characteristics: three chains, 10000 tunings, 10000 burn-ins, 1000000 samples, thinning=20.|Priors for model parameters: intercept = Normal(mean=0, variance=100), baseline risk and preop diagnosis parameters = Normal(mean=0, variance=1), treatment and the interaction term = Normal(mean=0, variance=0.31416), random effect standard deviation = Half-Normal(mean=0, variance=10). The posterior median relative risk of Initial Laparotomy over Initial Drainage was 0.75, 95% credible interval of (0.48, 1.16).|||
72551143|NCT01029353|144632557|SUPERIORITY||Risk Ratio (RR)|0.9|||||TWO_SIDED|95.0|0.7|1.15|||||RR: Initial Laparotomy over Peritoneal Drain. RR from robust Poisson regression with log link, reference cell coding, center as repeated measure. Model included treatment, baseline risk of death or NDI, and pre-op diagnosis (NEC/IP) as covariates.|A frequentist analysis.||1.15|0.70|
72551144|NCT01029353|144632557|SUPERIORITY|||||||||||||||||A Bayesian analysis. Initial Laparotomy and Initial Peritoneal Drain were compared using log-binomial regression. The SAS procedure PROC MCMC with effect coding was used. Center (random effect), treatment, pre-operative diagnosis, and baseline risk of death or NDI were binary covariates. Pre-operative diagnosis levels were NEC and IP. Markov chain Monte Carlo (MCMC) characteristics: three chains, 10000 tunings, 10000 burn-ins, 1000000 samples, thinning=20.|Priors for model parameters: intercept = Normal(mean=0, variance=100), baseline risk and preop diagnosis parameters = Normal(mean=0, variance=1), treatment and the interaction term = Normal(mean=0, variance=0.31416), random effect standard deviation = Half-Normal(mean=0, variance=10). The posterior median relative risk of Initial Laparotomy over Initial Drainage was 0.91, 95% credible interval of (0.65, 1.27).|||
72551145|NCT01029353|144632558|SUPERIORITY||Risk Ratio (RR)|0.77|||||TWO_SIDED|95.0|0.44|1.36|||||RR: Initial Laparotomy over Peritoneal Drain. RR from robust Poisson regression with log link, reference cell coding, center as repeated measure. Model included treatment, baseline risk of death or NDI, and pre-op diagnosis (NEC/IP) as covariates.|A frequentist analysis.||1.36|0.44|
72551146|NCT01029353|144632558|SUPERIORITY|||||||||||||||||A Bayesian analysis. Initial Laparotomy and Initial Peritoneal Drain were compared using log-binomial regression. The SAS procedure PROC MCMC with reference cell coding was used. Center (random effect), treatment, pre-operative diagnosis, and baseline risk of death or NDI were binary covariates. Pre-operative diagnosis levels were NEC and IP. Markov chain Monte Carlo (MCMC) characteristics: three chains, 10000 tunings, 10000 burn-ins, 1000000 samples, thinning=20.|Priors for model parameters: intercept = Normal(mean=0, variance=100), baseline risk and preop diagnosis parameters = Normal(mean=0, variance=1), treatment and the interaction term = Normal(mean=0, variance=0.31416), random effect standard deviation = Half-Normal(mean=0, variance=10). The posterior median relative risk of Initial Laparotomy over Initial Drainage was 0.82, 95% credible interval of (0.49, 1.33).|||
72551147|NCT01029353|144632559|SUPERIORITY||Mean Difference (Final Values)|-6.01|||||TWO_SIDED|95.0|-12.77|0.75|||||Mean Difference (MD): Laparotomy minus Drain. MD from mixed model using PROC MIXED in SAS, center as random effect, and reference cell coding. Model included treatment, baseline risk of death or NDI, and pre-op diagnosis (NEC/IP) as covariates.|A frequentist analysis.||0.75|-12.77|
72551148|NCT01029353|144632559|SUPERIORITY|||||||||||||||||A Bayesian analysis. Initial Laparotomy and Initial Peritoneal Drain were compared using a hierarchical linear regression. The SAS procedure PROC MCMC with reference cell coding was used. Center (random effect), treatment, pre-operative diagnosis, and baseline risk of death or NDI were binary covariates. Pre-operative diagnosis levels were NEC and IP. Markov chain Monte Carlo (MCMC) characteristics: three chains, 10000 tunings, 10000 burn-ins, 1000000 samples, thinning=20.|Priors for model parameters: intercept = Normal(mean=0, variance=1000), treatment, baseline risk, and preop diagnosis parameters = Normal(mean=0, variance=10), random effect standard deviation = Half-Normal(mean=0, variance=10). The posterior median difference Initial Laparotomy minus Initial Drainage was -2.68, 95% credible interval of (-7.11, 1.83).|||
72551149|NCT01029353|144632560|SUPERIORITY||Mean Difference (Final Values)|-8.75|||||TWO_SIDED|95.0|-17.05|-0.46|||||Mean Difference (MD): Laparotomy minus Drain. MD from mixed model using PROC MIXED in SAS, center as random effect, and reference cell coding. Model included treatment, baseline risk of death or NDI, and pre-op diagnosis (NEC/IP) as covariates.|A frequentist analysis.||-0.46|-17.05|
72551150|NCT01029353|144632560|SUPERIORITY|||||||||||||||||A Bayesian analysis. Initial Laparotomy and Initial Peritoneal Drain were compared using a hierarchical linear regression. The SAS procedure PROC MCMC with reference cell coding was used. Center (random effect), treatment, pre-operative diagnosis, and baseline risk of death or NDI were binary covariates. Pre-operative diagnosis levels were NEC and IP. Markov chain Monte Carlo (MCMC) characteristics: three chains, 10000 tunings, 10000 burn-ins, 1000000 samples, thinning=20.|Priors for model parameters: intercept = Normal(mean=0, variance=1000), treatment, baseline risk, and preop diagnosis parameters = Normal(mean=0, variance=10), random effect standard deviation = Half-Normal(mean=0, variance=10). The posterior median difference Initial Laparotomy minus Initial Drainage was -3.23, 95% credible interval of (-8.08, 1.68).|||
72583672|NCT03349060|144698372|SUPERIORITY||Difference in Percentage|15.3||||0.0019|TWO_SIDED|95.0|7.3|23.2||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||23.2|7.3|0.0019
72583673|NCT03349060|144698372|SUPERIORITY||Difference in Percentage|10.8||||0.0078|TWO_SIDED|95.0|4.2|17.4||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||17.4|4.2|0.0078
72583674|NCT03349060|144698372|SUPERIORITY||Difference in Percentage|22.2|||<|0.0001|TWO_SIDED|95.0|14.2|30.1||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||30.1|14.2|<0.0001
72583675|NCT03349060|144698372|SUPERIORITY||Difference in Percentage|8.2||||0.0528|TWO_SIDED|95.0|1.0|15.3||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||15.3|1.0|0.0528
72583676|NCT03349060|144698372|SUPERIORITY||Difference in Percentage|26.4|||<|0.0001|TWO_SIDED|95.0|17.6|35.3||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||35.3|17.6|<0.0001
72551151|NCT01029353|144632561|SUPERIORITY||Mean Difference (Final Values)|6.59|||||TWO_SIDED|95.0|-9.09|22.27|||||Mean Difference (MD): Laparotomy minus Drain. MD from mixed model using PROC MIXED in SAS, center as random effect, and reference cell coding. Model included treatment, baseline risk of death or NDI, and pre-op diagnosis (NEC/IP) as covariates.|A frequentist analysis.||22.27|-9.09|
72551152|NCT01029353|144632561|SUPERIORITY|||||||||||||||||A Bayesian analysis. Initial Laparotomy and Initial Peritoneal Drain were compared using a hierarchical linear regression. The SAS procedure PROC MCMC with reference coding was used. Center (random effect), treatment, pre-operative diagnosis, and baseline risk of death or NDI were binary covariates. Pre-operative diagnosis levels were NEC and IP. Markov chain Monte Carlo (MCMC) characteristics: three chains, 10000 tunings, 10000 burn-ins, 1000000 samples, thinning=20.|Priors for model parameters: intercept = Normal(mean=0, variance=1000), treatment, baseline risk, and preop diagnosis parameters = Normal(mean=0, variance=10), random effect standard deviation = Half-Normal(mean=0, variance=10). The posterior median difference Initial Laparotomy minus Initial Drainage was 1.65, 95% credible interval of (-3.97, 7.23).|||
72551153|NCT01029353|144632562|SUPERIORITY||Mean Difference (Final Values)|-2.56|||||TWO_SIDED|95.0|-13.02|7.91|||||Mean Difference (MD): Laparotomy minus Drain. MD from mixed model using PROC MIXED in SAS, center as random effect, and reference cell coding. Model included treatment, baseline risk of death or NDI, and pre-op diagnosis (NEC/IP) as covariates.|A frequentist analysis.||7.91|-13.02|
72583677|NCT03349060|144698373|SUPERIORITY||Difference in LS mean|-1.3|||<|0.0001|TWO_SIDED|95.0|-1.9|-0.6|||Mixed Models Analysis|||Change at Week 2: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-0.6|-1.9|<0.0001
72583678|NCT03349060|144698373|SUPERIORITY||Difference in LS mean|-2.3|||<|0.0001|TWO_SIDED|95.0|-3.0|-1.7|||Mixed Models Analysis|||Change at Week 2: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-1.7|-3.0|<0.0001
72583679|NCT03349060|144698373|SUPERIORITY||Difference in LS mean|-1.6|||<|0.0001|TWO_SIDED|95.0|-2.2|-0.9|||Mixed Models Analysis|||Change at Week 4: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-0.9|-2.2|<0.0001
72583680|NCT03349060|144698373|SUPERIORITY||Difference in LS mean|-2.7|||<|0.0001|TWO_SIDED|95.0|-3.4|-2.0|||Mixed Models Analysis|||Change at Week 4: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-2.0|-3.4|<0.0001
72413034|NCT00071487|144334675|SUPERIORITY_OR_OTHER|||||||0.6423||95.0||||P-value was not adjusted for multiple testing.|Log Rank|||Patients who required protocol-prohibited medications were considered to have a flare on the date the prohibited medication was started or date of the first flare, whichever came first. Patients who withdrew from the study for reasons other than SLE disease manifestations or hospitalization related to SLE or who missed 2 or more consecutive visits were censored at the time of the last assessment.||||0.6423
72413035|NCT00071487|144334675|SUPERIORITY_OR_OTHER|||||||0.8536||95.0||||P-value was not adjusted for multiple testing.|Log Rank|||Patients who required protocol-prohibited medications were considered to have a flare on the date the prohibited medication was started or date of the first flare, whichever came first. Patients who withdrew from the study for reasons other than SLE disease manifestations or hospitalization related to SLE or who missed 2 or more consecutive visits were censored at the time of the last assessment.||||0.8536
72413036|NCT00071487|144334675|SUPERIORITY_OR_OTHER|||||||0.9705||95.0||||P-value was not adjusted for multiple testing.|Log Rank|||Patients who required protocol-prohibited medications were considered to have a flare on the date the prohibited medication was started or date of the first flare, whichever came first. Patients who withdrew from the study for reasons other than SLE disease manifestations or hospitalization related to SLE or who missed 2 or more consecutive visits were censored at the time of the last assessment.||||0.9705
72413037|NCT00071487|144334676|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.1||||0.1763|TWO_SIDED|95.0|-22.4|4.1||P-value was not adjusted for multiple testing.|t-test, 2 sided|||Missing data was handled by using LOCF imputation. If patient required a protocol-prohibited medication, the SELENA SLEDAI score of the last visit prior to the use of the prohibited medication was used.||4.1|-22.4|0.1763
72413038|NCT00071487|144334676|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.3||||0.7112|TWO_SIDED|95.0|-20.9|14.3||P-value was not adjusted for multiple testing.|t-test, 2 sided|||Missing data was handled by using LOCF imputation. If patient required a protocol-prohibited medication, the SELENA SLEDAI score of the last visit prior to the use of the prohibited medication was used.||14.3|-20.9|0.7112
72413039|NCT00071487|144334676|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.4||||0.332|TWO_SIDED|95.0|-22.2|7.5||P-value was not adjusted for multiple testing.|t-test, 2 sided|||Missing data was handled by using LOCF imputation. If patient required a protocol-prohibited medication, the SELENA SLEDAI score of the last visit prior to the use of the prohibited medication was used.||7.5|-22.2|0.3320
72413040|NCT00071487|144334677|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-28.6||||0.1287|TWO_SIDED|95.0|-65.6|8.4||P-value was not adjusted for multiple testing.|t-test, 2 sided|||Missing data was handled by using LOCF imputation. If patient required a protocol-prohibited medication, the SELENA SLEDAI score of the last visit prior to the use of the prohibited medication was used.||8.4|-65.6|0.1287
72413041|NCT00071487|144334677|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.98||||0.8807|TWO_SIDED|95.0|-36.2|42.1||P-value was not adjusted for multiple testing.|t-test, 2 sided|||Missing data was handled by using LOCF imputation.||42.1|-36.2|0.8807
72413042|NCT00071487|144334677|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-30.41||||0.1131|TWO_SIDED|95.0|-68.1|7.3||P-value was not adjusted for multiple testing.|t-test, 2 sided|||Missing data was handled by using LOCF imputation.||7.3|-68.1|0.1131
72413043|NCT00071487|144334678|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.7||||0.7823|TWO_SIDED|95.0|-13.8|10.4||P-value was not adjusted for multiple testing|t-test, 2 sided|||Missing data for BILAG were handled as described previously for SELENA SLEDAI.||10.4|-13.8|0.7823
72413044|NCT00071487|144334678|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.4||||0.1774|TWO_SIDED|95.0|-18.2|3.4||P-value was not adjusted for multiple testing.|t-test, 2 sided|||Missing data for BILAG were handled as described previously for SELENA SLEDAI.||3.4|-18.2|0.1774
72551154|NCT01029353|144632562|SUPERIORITY|||||||||||||||||A Bayesian analysis. Initial Laparotomy and Initial Peritoneal Drain were compared using a hierarchical linear regression. The SAS procedure PROC MCMC with reference cell coding was used. Center (random effect), treatment, pre-operative diagnosis, and baseline risk of death or NDI were binary covariates. Pre-operative diagnosis levels were NEC and IP. Markov chain Monte Carlo (MCMC) characteristics: three chains, 10000 tunings, 10000 burn-ins, 1000000 samples, thinning=20.|Priors for model parameters: intercept = Normal(mean=0, variance=1000), treatment, baseline risk, and preop diagnosis parameters = Normal(mean=0, variance=10), random effect standard deviation = Half-Normal(mean=0, variance=10). The posterior median difference Initial Laparotomy minus Initial Drainage was -0.71, 95% credible interval of (-5.89, 4.48).|||
72413045|NCT00071487|144334678|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.8||||0.6406|TWO_SIDED|95.0|-14.8|9.1|||t-test, 2 sided|P-value was not adjusted for multiple testing.||Missing data for BILAG were handled as described previously for SELENA SLEDAI.||9.1|-14.8|0.6406
72413046|NCT00071487|144334679|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.8||||0.7822|TWO_SIDED|95.0|-38.6|29.1||P-value was not adjusted for multiple testing.|t-test, 2 sided|||Missing data for BILAG were handled as described previously for SELENA SLEDAI.||29.1|-38.6|0.7822
72413047|NCT00071487|144334679|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.9||||0.3332|TWO_SIDED|95.0|-45.3|15.4||P-value was not adjusted for multiple testing.|t-test, 2 sided|||Missing data for BILAG were handled as described previously for SELENA SLEDAI.||15.4|-45.3|0.3332
72413048|NCT00071487|144334679|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.7||||0.466|TWO_SIDED|95.0|-46.9|21.5||P-value was not adjusted for multiple testing.|t-test, 2 sided|||Missing data for BILAG were handled as described previously for SELENA SLEDAI.||21.5|-46.9|0.4660
72413049|NCT00071487|144334680|SUPERIORITY_OR_OTHER|||||||0.5615||95.0||||P-value was not adjusted for multiple comparisons.|Log Rank|||Missing data for BILAG were handled as described previously for SELENA SLEDAI (SLE Flare Index).||||0.5615
72413050|NCT00071487|144334680|SUPERIORITY_OR_OTHER|||||||0.7593||95.0||||P-value was not adjusted for multiple testing.|Log Rank|||Missing data for BILAG were handled as described previously for SELENA SLEDAI (SLE Flare Index).||||0.7593
72583681|NCT03349060|144698373|SUPERIORITY||Difference in LS mean|-1.5|||<|0.0001|TWO_SIDED|95.0|-2.3|-0.8|||Mixed Models Analysis|||Change at Week 8: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-0.8|-2.3|<0.0001
72583682|NCT03349060|144698373|SUPERIORITY||Difference in LS mean|-2.5|||<|0.0001|TWO_SIDED|95.0|-3.2|-1.8|||Mixed Models Analysis|||Change at Week 8: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-1.8|-3.2|<0.0001
72583683|NCT03349060|144698373|SUPERIORITY||Difference in LS mean|-1.3||||0.0005|TWO_SIDED|95.0|-2.1|-0.6|||Mixed Models Analysis|||Change at Week 12: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-0.6|-2.1|0.0005
72583684|NCT03349060|144698373|SUPERIORITY||Difference in LS mean|-2.1|||<|0.0001|TWO_SIDED|95.0|-2.9|-1.4|||Mixed Models Analysis|||Change at Week 12: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-1.4|-2.9|<0.0001
72583685|NCT03349060|144698374|SUPERIORITY||Difference in LS mean|-10.9|||<|0.0001|TWO_SIDED|95.0|-14.8|-7.0|||Mixed Models Analysis|||Change at Week 2: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-7.0|-14.8|<0.0001
72583686|NCT03349060|144698374|SUPERIORITY||Difference in LS mean|-18.9|||<|0.0001|TWO_SIDED|95.0|-22.7|-15.1|||Mixed Models Analysis|||Change at Week 2: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-15.1|-22.7|<0.0001
72583687|NCT03349060|144698374|SUPERIORITY||Difference in LS mean|-12.6|||<|0.0001|TWO_SIDED|95.0|-17.3|-7.8|||Mixed Models Analysis|||Change at Week 4: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-7.8|-17.3|<.0001
72583688|NCT03349060|144698374|SUPERIORITY||Difference in LS mean|-22.1|||<|0.0001|TWO_SIDED|95.0|-26.8|-17.3|||Mixed Models Analysis|||Change at Week 4: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-17.3|-26.8|<.0001
72583689|NCT03349060|144698374|SUPERIORITY||Difference in LS mean|-14.3|||<|0.0001|TWO_SIDED|95.0|-19.5|-9.0|||Mixed Models Analysis|||Change at Week 8: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-9.0|-19.5|<.0001
72583690|NCT03349060|144698374|SUPERIORITY||Difference in LS mean|-22.0|||<|0.0001|TWO_SIDED|95.0|-27.2|-16.7|||Mixed Models Analysis|||Change at Week 8: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-16.7|-27.2|<.0001
72583691|NCT03349060|144698374|SUPERIORITY||Difference in LS mean|-13.3|||<|0.0001|TWO_SIDED|95.0|-19.0|-7.7|||Mixed Models Analysis|||Change at Week 12: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-7.7|-19.0|<0.0001
72583692|NCT03349060|144698374|SUPERIORITY||Difference in LS mean|-21.9|||<|0.0001|TWO_SIDED|95.0|-27.5|-16.3|||Mixed Models Analysis|||Change at Week 12: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-16.3|-27.5|<.0001
72583693|NCT03349060|144698375|SUPERIORITY||Difference in Percentage|22.3||||0.0028|TWO_SIDED|95.0|8.7|35.9||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||35.9|8.7|0.0028
72583694|NCT03349060|144698375|SUPERIORITY||Difference in Percentage|40.1|||<|0.0001|TWO_SIDED|95.0|27.1|53.2||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||53.2|27.1|<0.0001
72413051|NCT00071487|144334680|SUPERIORITY_OR_OTHER|||||||0.2273||95.0||||P-value was not adjusted for multiple testing.|Log Rank|||Missing data for BILAG were handled as described previously for SELENA SLEDAI (SLE Flare Index).||||0.2273
72413052|NCT00071487|144334681|SUPERIORITY_OR_OTHER||percent difference from placebo|-7.1||||0.4355|TWO_SIDED|95.0|-24.7|10.6||P-value was not adjusted for multiple testing.|Likelihood ratio chi-squared|||Patients who dropped out or had missing data were considered failures.||10.6|-24.7|0.4355
72413053|NCT00071487|144334681|SUPERIORITY_OR_OTHER||percent difference from placebo|4.4||||0.6669|TWO_SIDED|95.0|-15.5|24.2||P-value was not adjusted for multiple testing.|Likelihood ratio chi-squared|||Patients who dropped out or had missing data were considered failures.||24.2|-15.5|0.6669
72413054|NCT00071487|144334681|SUPERIORITY_OR_OTHER||percent difference from placebo|17.7||||0.0882|TWO_SIDED|95.0|-2.5|37.9||P-value was not adjusted for multiple testing.|Likelihood ratio chi-squared|||Patients who dropped out or had missing data were considered failures.||37.9|-2.5|0.0882
72413055|NCT01227889|144334696|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.4|||<|0.0001|TWO_SIDED|95.0|0.26|0.6||The p value from a stratified log-rank test was adjusted for disease stage at screening.|Log Rank||HRs were estimated using a Pike estimator. HR from a stratified log-rank test was adjusted for disease stage at screening.|||0.60|0.26|<0.0001
72583695|NCT03349060|144698375|SUPERIORITY||Difference in Percentage|17.1||||0.0217|TWO_SIDED|95.0|2.8|31.4||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||31.4|2.8|0.0217
72583696|NCT03349060|144698375|SUPERIORITY||Difference in Percentage|32.2|||<|0.0001|TWO_SIDED|95.0|18.5|45.9||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||45.9|18.5|<0.0001
72583697|NCT03349060|144698375|SUPERIORITY||Difference in Percentage|15.7||||0.0363|TWO_SIDED|95.0|1.4|30.0||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||30.0|1.4|0.0363
72583698|NCT03349060|144698375|SUPERIORITY||Difference in Percentage|23.7||||0.0011|TWO_SIDED|95.0|9.8|37.7||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||37.7|9.8|0.0011
72583699|NCT03349060|144698375|SUPERIORITY||Difference in Percentage|20.1||||0.008|TWO_SIDED|95.0|5.8|34.5||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||34.5|5.8|0.0080
72583700|NCT03349060|144698375|SUPERIORITY||Difference in Percentage|29.1|||<|0.0001|TWO_SIDED|95.0|15.0|43.3||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||43.3|15.0|<0.0001
72583701|NCT03349060|144698376|SUPERIORITY||Difference in LS mean|-3.8|||<|0.0001|TWO_SIDED|95.0|-5.4|-2.2|||Mixed Models Analysis|||Change at Week 2: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-2.2|-5.4|<0.0001
72413056|NCT01227889|144334697|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.35|||||TWO_SIDED|95.0|0.2|0.61|||||HRs were estimated using a Pike estimator. HR was adjusted for disease stage at screening.|||0.61|0.20|
72413057|NCT01227889|144334698|OTHER||Hazard Ratio (HR)|0.82|||||TWO_SIDED|95.0|0.57|1.18|||||HRs were estimated using a Pike estimator. HR was adjusted for disease stage at screening.|||1.18|0.57|
72413058|NCT01169467|144334785|SUPERIORITY_OR_OTHER|||||||0.395|TWO_SIDED||||||t-test, 2 sided|||||||0.395
72583702|NCT03349060|144698376|SUPERIORITY||Difference in LS mean|-5.5|||<|0.0001|TWO_SIDED|95.0|-7.1|-3.9|||Mixed Models Analysis|||Change at Week 2: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-3.9|-7.1|<0.0001
72413059|NCT04827212|144334789|SUPERIORITY||Mean Difference (Final Values)|0.31||||0.037|TWO_SIDED|||||P\<0.05|Mixed Models Analysis|||||||0.037
72413060|NCT04827212|144334790|SUPERIORITY||Mean Difference (Final Values)|-0.02||||0.78|TWO_SIDED|||||p-value is adjusted for multiple comparisons- P\<0.025; controlled for baseline values as there was a significant difference between groups at baseline|Mixed Models Analysis|||||||0.78
72413061|NCT04827212|144334791|SUPERIORITY||Mean Difference (Final Values)|0.05||||0.56|TWO_SIDED|||||adjusted for multiple comparisons- P\<0.025; controlled for baseline value due to a significant difference between groups at baseline|Mixed Models Analysis|||||||0.56
72413062|NCT04827212|144334792|SUPERIORITY||Mean Difference (Final Values)|-0.49||||0.4|TWO_SIDED||||||Mixed Models Analysis|||||||0.4
72413063|NCT04827212|144334793|SUPERIORITY||Mean Difference (Final Values)|-0.8||||0.18|TWO_SIDED|||||p-value is adjusted for multiple comparisons and significance threshold was set at P\<0.0167|Mixed Models Analysis|||||||0.18
72413064|NCT04827212|144334794|SUPERIORITY||Mean Difference (Final Values)|-0.11||||0.86|TWO_SIDED|||||p-value is adjusted for multiple comparisons and significance threshold was set at P\<0.0167|Mixed Models Analysis|||||||0.86
72583703|NCT03349060|144698376|SUPERIORITY||Difference in LS mean|-3.3||||0.0001|TWO_SIDED|95.0|-5.0|-1.7|||Mixed Models Analysis|||Change at Week 4: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-1.7|-5.0|0.0001
72583704|NCT03349060|144698376|SUPERIORITY||Difference in LS mean|-6.1|||<|0.0001|TWO_SIDED|95.0|-7.8|-4.5|||Mixed Models Analysis|||Change at Week 4: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-4.5|-7.8|<.0001
72413065|NCT04827212|144334795|SUPERIORITY||Mean Difference (Final Values)|2.2||||0.21|TWO_SIDED|||||p-value is adjusted for multiple comparisons and significance threshold was set at P\<0.0167|Mixed Models Analysis|||||||0.21
72413066|NCT04827212|144334796|SUPERIORITY||Mean Difference (Final Values)|2.3||||0.19|TWO_SIDED|||||p-value is adjusted for multiple comparisons and significance threshold was set at P\<0.0167|Mixed Models Analysis|||||||0.19
72413067|NCT04827212|144334797|SUPERIORITY||Mean Difference (Final Values)|2.8||||0.12|TWO_SIDED|||||p-value is adjusted for multiple comparisons and significance threshold was set at P\<0.0167|Mixed Models Analysis|||||||0.12
72413068|NCT04827212|144334798|SUPERIORITY||Mean Difference (Final Values)|6.2||||0.41|TWO_SIDED|||||p-value is adjusted for multiple comparisons and significance threshold was set at P\<0.0167|Mixed Models Analysis|||||||0.41
72413069|NCT04827212|144334799|SUPERIORITY||Mean Difference (Final Values)|6.2||||0.43|TWO_SIDED|||||p-value is adjusted for multiple comparisons and significance threshold was set at P\<0.0167|Mixed Models Analysis|||||||0.43
72583705|NCT03349060|144698376|SUPERIORITY||Difference in LS mean|-2.8||||0.0075|TWO_SIDED|95.0|-4.8|-0.7|||Mixed Models Analysis|||Change at Week 8: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-0.7|-4.8|0.0075
72583706|NCT03349060|144698376|SUPERIORITY||Difference in LS mean|-5.3|||<|0.0001|TWO_SIDED|95.0|-7.4|-3.3|||Mixed Models Analysis|||Change at Week 8: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-3.3|-7.4|<0.0001
72583707|NCT03349060|144698376|SUPERIORITY||Difference in LS mean|-2.8||||0.0072|TWO_SIDED|95.0|-4.8|-0.8|||Mixed Models Analysis|||Change at Week 12: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-0.8|-4.8|0.0072
72583708|NCT03349060|144698376|SUPERIORITY||Difference in LS mean|-4.9|||<|0.0001|TWO_SIDED|95.0|-6.9|-2.9|||Mixed Models Analysis|||Change at Week 12: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-2.9|-6.9|<0.0001
72583709|NCT03349060|144698377|SUPERIORITY||Difference in LS mean|-1.3||||0.275|TWO_SIDED|95.0|-3.5|1.0|||Mixed Models Analysis|||Change at Week 2: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||1.0|-3.5|0.2750
72583710|NCT03349060|144698377|SUPERIORITY||Difference in LS mean|-2.5||||0.028|TWO_SIDED|95.0|-4.8|-0.3|||Mixed Models Analysis|||Change at Week 2: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-0.3|-4.8|0.0280
72583711|NCT03349060|144698377|SUPERIORITY||Difference in LS mean|-3.5||||0.0051|TWO_SIDED|95.0|-5.9|-1.1|||Mixed Models Analysis|||Change at Week 4: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-1.1|-5.9|0.0051
72413070|NCT04827212|144334800|SUPERIORITY||Mean Difference (Final Values)|5.0||||0.53|TWO_SIDED|||||p-value is adjusted for multiple comparisons and significance threshold was set at P\<0.0167|Mixed Models Analysis|||||||0.53
72413071|NCT04827212|144334801|SUPERIORITY||Mean Difference (Final Values)|-0.17||||0.98|TWO_SIDED|||||p-value is adjusted for multiple comparisons and significance threshold was set at P\<0.0167|Mixed Models Analysis|||||||0.98
72413072|NCT04827212|144334802|SUPERIORITY||Mean Difference (Final Values)|-0.47||||0.96|TWO_SIDED|||||p-value is adjusted for multiple comparisons and significance threshold was set at P\<0.0167|Mixed Models Analysis|||||||0.96
72413073|NCT04827212|144334803|SUPERIORITY||Mean Difference (Final Values)|1.1||||0.91|TWO_SIDED|||||p-value is adjusted for multiple comparisons and significance threshold was set at P\<0.0167|Mixed Models Analysis|||||||0.91
72413074|NCT04827212|144334804|SUPERIORITY||Mean Difference (Final Values)|13.1||||0.25|TWO_SIDED|||||p-value is adjusted for multiple comparisons and significance threshold was set at P\<0.0167|Mixed Models Analysis|||||||0.25
72413075|NCT04827212|144334805|SUPERIORITY||Mean Difference (Final Values)|8.5||||0.46|TWO_SIDED|||||p-value is adjusted for multiple comparisons and significance threshold was set at P\<0.0167|Mixed Models Analysis|||||||0.46
72413076|NCT04827212|144334806|SUPERIORITY||Mean Difference (Final Values)|9.6||||0.41|TWO_SIDED|||||p-value is adjusted for multiple comparisons and significance threshold was set at P\<0.0167|Mixed Models Analysis|||||||0.41
72413077|NCT04827212|144334807|SUPERIORITY||Mean Difference (Final Values)|-13.8||||0.12|TWO_SIDED|||||p-value is adjusted for multiple comparisons and significance threshold was set at P\<0.0167|Mixed Models Analysis|||||||0.12
72583712|NCT03349060|144698377|SUPERIORITY||Difference in LS mean|-6.4|||<|0.0001|TWO_SIDED|95.0|-8.8|-4.0|||Mixed Models Analysis|||Change at Week 4: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-4.0|-8.8|<0.0001
72413078|NCT04827212|144334808|SUPERIORITY||Mean Difference (Final Values)|-11.9||||0.2|TWO_SIDED|||||p-value is adjusted for multiple comparisons and significance threshold was set at P\<0.0167|Mixed Models Analysis|||||||0.20
72413079|NCT04827212|144334809|SUPERIORITY||Mean Difference (Final Values)|-14.0||||0.13|TWO_SIDED|||||p-value is adjusted for multiple comparisons and significance threshold was set at P\<0.0167|Mixed Models Analysis|||||||0.13
72413080|NCT04827212|144334810|SUPERIORITY||Mean Difference (Final Values)|0.83||||0.94|TWO_SIDED|||||p-value is adjusted for multiple comparisons and significance threshold was set at P\<0.0167|Mixed Models Analysis|||||||0.94
72413081|NCT04827212|144334811|SUPERIORITY||Mean Difference (Final Values)|4.4||||0.72|TWO_SIDED|||||p-value is adjusted for multiple comparisons and significance threshold was set at P\<0.0167|Mixed Models Analysis|||||||0.72
72413082|NCT04827212|144334812|SUPERIORITY||Mean Difference (Final Values)|12.3||||0.33|TWO_SIDED|||||p-value is adjusted for multiple comparisons and significance threshold was set at P\<0.0167|Mixed Models Analysis|||||||0.33
72413083|NCT03108924|144334818|OTHER||GMR|0.77|||||TWO_SIDED|90.0|0.53|1.13||||Categorical Analysis|GMR = GM for ESRD HD / GM for ESRD Non-HD|||1.13|0.53|
72413084|NCT03108924|144334821|OTHER||GMR|2.98|||||TWO_SIDED|90.0|2.01|4.41||||Categorical Analysis|GMR = GM for Moderate RI / GM for Healthy Controls|||4.41|2.01|
72413085|NCT03108924|144334821|OTHER||GMR|4.43|||||TWO_SIDED|95.0|2.82|6.96||||Categorical Analysis|GMR = GM for Severe RI / GM for Healthy Controls|||6.96|2.82|
72413086|NCT03108924|144334821|OTHER||GMR|4.74|||||TWO_SIDED|90.0|2.95|7.59||||Categorical Analysis|GMR = GM for ESRD HD / GM for Healthy Controls|||7.59|2.95|
72413087|NCT03108924|144334823|OTHER||GMR|0.77|||||TWO_SIDED|90.0|0.54|1.08||||Categorical Analysis|GMR = GM for ESRD HD / GM for ESRD Non-HD|||1.08|0.54|
72413088|NCT03108924|144334826|OTHER||GMR|3.23|||||TWO_SIDED|90.0|2.01|5.2||||Categorical Analysis|GMR = GM for Moderate RI / GM for Healthy Controls|||5.20|2.01|
72413089|NCT03108924|144334826|OTHER||GMR|4.08|||||TWO_SIDED|90.0|2.49|6.7||||Categorical Analysis|GMR = GM for Severe RI / GM for Healthy Controls|||6.70|2.49|
72413090|NCT03108924|144334826|OTHER||GMR|4.43|||||TWO_SIDED|90.0|2.65|7.39||||Categorical Analysis|GMR = GM for ESRD Non-HD / GM for Healthy Controls|||7.39|2.65|
72551155|NCT01029353|144632563|SUPERIORITY||Mean Difference (Final Values)|-13.95|||||TWO_SIDED|95.0|-30.54|2.63|||||Mean Difference (MD): Laparotomy minus Drain. MD from mixed model using PROC MIXED in SAS, center as random effect, and reference cell coding. Model included treatment, baseline risk of death or NDI, and pre-op diagnosis (NEC/IP) as covariates.|A frequentist analysis.||2.63|-30.54|
72552865|NCT06358820|144636740|SUPERIORITY|\>0.15 g/dL change in albumin from baseline to month 6 was anticipated.|Mean Difference (Final Values)|3.77|||<|0.0125|TWO_SIDED|95.0|3.15|4.39||A 2-sided P value less than 0.05 was considered statistically significant. However, the significance level (α) was adjusted to 0.0125 to account for multiple testing.|ANOVA||The main analysis was based on LOCF for missing value.|Outcome Measure were assessed at baseline and every month during the 6-month study.||4.39|3.15|<0.0125
72413091|NCT03108924|144334828|OTHER||GMR|0.73|||||TWO_SIDED|90.0|0.52|1.03||||Categorical Analysis|GMR = GM for ESRD HD / GM for ESRD Non-HD|||1.03|0.52|
72413092|NCT03108924|144334831|OTHER||GMR|2.09|||||TWO_SIDED|90.0|1.22|3.56||||Categorical Analysis|GMR = GM for Moderate RI / GM for Healthy Controls|||3.56|1.22|
72413093|NCT03108924|144334831|OTHER||GMR|1.89|||||TWO_SIDED|95.0|1.1|3.25||||Categorical Analysis|GMR = GM for Severe RI / GM for Healthy Controls|||3.25|1.10|
72413094|NCT03108924|144334831|OTHER||GMR|1.9|||||TWO_SIDED|90.0|1.13|3.19||||Categorical Analysis|GMR = GM for ESRD Non-HD / GM for Healthy Controls|||3.19|1.13|
72413095|NCT03108924|144334833|OTHER||GMR|1.3|||||TWO_SIDED|90.0|0.88|1.9||||Categorical Analysis|GMR = GM for ESRD / GM for ESRD Non-HD|||1.90|0.88|
72413096|NCT03108924|144334836|OTHER||GMR|0.34|||||TWO_SIDED|95.0|0.23|0.5||||Categorical Analysis|GMR = GM for Moderate RI / GM for Healthy Controls|||0.50|0.23|
72413097|NCT03108924|144334836|OTHER||GMR|0.23|||||TWO_SIDED|95.0|0.14|0.35||||Categorical Analysis|GMR = GM for Severe RI / GM for Healthy Controls|||0.35|0.14|
72583713|NCT03349060|144698377|SUPERIORITY||Difference in LS mean|-2.1||||0.1706|TWO_SIDED|95.0|-5.1|0.9|||Mixed Models Analysis|||Change at Week 8: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||0.9|-5.1|0.1706
72583714|NCT03349060|144698377|SUPERIORITY||Difference in LS mean|-4.4||||0.0048|TWO_SIDED|95.0|-7.4|-1.4|||Mixed Models Analysis|||Change at Week 8: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-1.4|-7.4|0.0048
72583715|NCT03349060|144698377|SUPERIORITY||Difference in LS mean|-2.5||||0.0629|TWO_SIDED|95.0|-5.2|0.1|||Mixed Models Analysis|||Change at Week 12: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||0.1|-5.2|0.0629
72583716|NCT03349060|144698377|SUPERIORITY||Difference in LS mean|-3.6||||0.01|TWO_SIDED|95.0|-6.2|-0.9|||Mixed Models Analysis|||Change at Week 12: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-0.9|-6.2|0.0100
72583717|NCT03349060|144698378|SUPERIORITY||Difference in Percentage|6.6||||0.1238|TWO_SIDED|95.0|-0.7|13.9||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||13.9|-0.7|0.1238
72583718|NCT03349060|144698378|SUPERIORITY||Difference in Percentage|20.1||||0.0008|TWO_SIDED|95.0|11.0|29.2||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||29.2|11.0|0.0008
72583719|NCT03349060|144698378|SUPERIORITY||Difference in Percentage|6.8||||0.2091|TWO_SIDED|95.0|-2.8|16.4||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||16.4|-2.8|0.2091
72583720|NCT03349060|144698378|SUPERIORITY||Difference in Percentage|24.0||||0.0005|TWO_SIDED|95.0|12.9|35.0||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||35.0|12.9|0.0005
72583721|NCT03349060|144698378|SUPERIORITY||Difference in Percentage|9.1||||0.1161|TWO_SIDED|95.0|-0.9|19.1||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||19.1|-0.9|0.1161
72583722|NCT03349060|144698378|SUPERIORITY||Difference in Percentage|26.5||||0.0002|TWO_SIDED|95.0|15.3|37.7||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||37.7|15.3|0.0002
72583723|NCT03349060|144698378|SUPERIORITY||Difference in Percentage|8.1||||0.1837|TWO_SIDED|95.0|-2.8|19.1||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||19.1|-2.8|0.1837
72583724|NCT03349060|144698378|SUPERIORITY||Difference in Percentage|19.8||||0.0046|TWO_SIDED|95.0|8.1|31.6||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||31.6|8.1|0.0046
72583725|NCT03349060|144698379|SUPERIORITY||Difference in Percentage|3.2||||0.4795|TWO_SIDED|95.0|-10.3|16.6||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||16.6|-10.3|0.4795
72583726|NCT03349060|144698379|SUPERIORITY||Difference in Percentage|0.0|||||TWO_SIDED|95.0|-12.7|12.7||P-value could not be calculated since percentage of participants with events was 0.||||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||12.7|-12.7|
72583727|NCT03349060|144698379|SUPERIORITY||Difference in Percentage|13.3||||0.1452|TWO_SIDED|95.0|-3.6|30.3||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||30.3|-3.6|0.1452
72413098|NCT03108924|144334836|OTHER||GMR|0.21|||||TWO_SIDED|95.0|0.13|0.34||||Categorical Analysis|GMR = GM for ESRD Non-HD / GM for Healthy Controls|||0.34|0.13|
72413099|NCT03108924|144334838|OTHER||GMR|0.31|||||TWO_SIDED|90.0|0.25|0.39||||Categorical Analysis|GMR = GM for Moderate RI / GM for Healthy Controls|||0.39|0.25|
72413100|NCT03108924|144334838|OTHER||GMR|0.1|||||TWO_SIDED|90.0|0.07|0.16||||Categorical Analysis|GMR = GM for Severe RI / GM for Healthy Controls|||0.16|0.07|
72552866|NCT06358820|144636741|SUPERIORITY|\>60 mg/L change in prealbumin from baseline to month 6.|Mean Difference (Net)|39.77||||0.0125|TWO_SIDED|95.0|26.66|56.87||A 2-sided P value less than 0.05 was considered statistically significant. However, the significance level (α) was adjusted to 0.0125 to account for multiple testing.|ANOVA||The main analysis was based on LOCF for missing value.|||56.87|26.66|0.0125
72413101|NCT00924885|144334845|SUPERIORITY|||||||0.04|||||||Wilcoxon (Mann-Whitney)|||The primary end-point was the 'overall pain experience', evaluated as described previously. Assuming the mean overall pain in the RN group to be 27 mm (value chosen after analysis of data from a previous study, Cerne et al., 2006) on VAS, with a standard deviation (SD) of 21.5 mm, 121 patients in each group would be needed to demonstrate a decrease in overall pain of 8 mm (30%) with 80% power and a significance level of 0.05 (two-tailed tests).||||0.04
72413102|NCT00784810|144334847|NON_INFERIORITY_OR_EQUIVALENCE|As above.|Mean Difference (Net)|0.44|STANDARD_ERROR_OF_MEAN|1.19||0.002|ONE_SIDED|90.0|-5.65||||Mixed Models Analysis|||To achieve a study with 80% power at the 1-sided 5% significance level, for the purposes of demonstrating non inferiority, a sample size of 98 subjects per treatment group was required, i.e. a total of 196 subjects completing the study.|||-5.65|0.002
72413103|NCT02508480|144334858|SUPERIORITY|||||||0.66|||||||Mixed Models Analysis|||The two study arms were compared using mixed models analysis controlling for baseline scores. Variables included in the model were- baseline score, group, time, and group by time interaction. The p-value reported below is for group effect.||||0.66
72413104|NCT02508480|144334859|SUPERIORITY|||||||0.884||||||Group effect for Proactive Coping|Mixed Models Analysis|||"The two study arms were compared using mixed models analysis controlling for baseline scores. Variables included in the model were- baseline score, group, time, and group by time interaction.~The p-value reported below is for group effect for Proactive Coping."||||0.884
72413105|NCT02508480|144334859|SUPERIORITY|||||||0.543||||||Group effect for Avoidant Coping.|Mixed Models Analysis|||"The two study arms were compared using mixed models analysis controlling for baseline scores. Variables included in the model were- baseline score, group, time, and group by time interaction.~The p-value reported below is for group effect for Avoidant Coping."||||0.543
72583728|NCT03349060|144698379|SUPERIORITY||Difference in Percentage|9.7||||0.2232|TWO_SIDED|95.0|-6.1|25.4||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||25.4|-6.1|0.2232
72583729|NCT03349060|144698379|SUPERIORITY||Difference in Percentage|5.8||||0.5707|TWO_SIDED|95.0|-13.7|25.4||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||25.4|-13.7|0.5707
72583730|NCT03349060|144698379|SUPERIORITY||Difference in Percentage|5.8||||0.5777|TWO_SIDED|95.0|-13.6|25.1||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||25.1|-13.6|0.5777
72583731|NCT03349060|144698379|SUPERIORITY||Difference in Percentage|19.3||||0.0744|TWO_SIDED|95.0|1.0|37.5||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||37.5|1.0|0.0744
72583732|NCT03349060|144698379|SUPERIORITY||Difference in Percentage|9.7||||0.2232|TWO_SIDED|95.0|-6.1|25.4||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||25.4|-6.1|0.2232
72583733|NCT03349060|144698380|SUPERIORITY||Difference in Percentage|31.6|||<|0.0001|TWO_SIDED|95.0|17.2|46.0||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||46.0|17.2|<0.0001
72583734|NCT03349060|144698380|SUPERIORITY||Difference in Percentage|35.7|||<|0.0001|TWO_SIDED|95.0|21.5|49.9||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||49.9|21.5|<0.0001
72583735|NCT03349060|144698380|SUPERIORITY||Difference in Percentage|20.4||||0.009|TWO_SIDED|95.0|5.2|35.6||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||35.6|5.2|0.0090
72583736|NCT03349060|144698380|SUPERIORITY||Difference in Percentage|33.3|||<|0.0001|TWO_SIDED|95.0|19.0|47.7||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||47.7|19.0|<0.0001
72583737|NCT03349060|144698380|SUPERIORITY||Difference in Percentage|16.5||||0.0421|TWO_SIDED|95.0|0.6|32.4||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||32.4|0.6|0.0421
72583738|NCT03349060|144698380|SUPERIORITY||Difference in Percentage|33.8|||<|0.0001|TWO_SIDED|95.0|18.9|48.8||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||48.8|18.9|<0.0001
72583739|NCT03349060|144698380|SUPERIORITY||Difference in Percentage|23.5||||0.0035|TWO_SIDED|95.0|8.2|38.8||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||38.8|8.2|0.0035
72583740|NCT03349060|144698380|SUPERIORITY||Difference in Percentage|28.8||||0.0002|TWO_SIDED|95.0|13.8|43.9||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||43.9|13.8|0.0002
72583741|NCT03349060|144698381|SUPERIORITY||Difference in Percentage|17.1||||0.2497|TWO_SIDED|95.0|-9.1|43.2||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||43.2|-9.1|0.2497
72583742|NCT03349060|144698381|SUPERIORITY||Difference in Percentage|17.1||||0.2371|TWO_SIDED|95.0|-9.0|43.3|||Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||43.3|-9.0|0.2371
72583743|NCT03349060|144698381|SUPERIORITY||Difference in Percentage|28.8||||0.0697|TWO_SIDED|95.0|-0.8|58.3||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||58.3|-0.8|0.0697
72583744|NCT03349060|144698381|SUPERIORITY||Difference in Percentage|43.9||||0.003|TWO_SIDED|95.0|16.2|71.7||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||71.7|16.2|0.0030
72583745|NCT03349060|144698381|SUPERIORITY||Difference in Percentage|31.0||||0.0583|TWO_SIDED|95.0|2.0|59.9||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||59.9|2.0|0.0583
72583746|NCT03349060|144698381|SUPERIORITY||Difference in Percentage|41.2||||0.0085|TWO_SIDED|95.0|13.2|69.1||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||69.1|13.2|0.0085
72583747|NCT03349060|144698381|SUPERIORITY||Difference in Percentage|19.3||||0.1948|TWO_SIDED|95.0|-9.8|48.5||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||48.5|-9.8|0.1948
72583748|NCT03349060|144698381|SUPERIORITY||Difference in Percentage|30.6||||0.0296|TWO_SIDED|95.0|2.8|58.5||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||58.5|2.8|0.0296
72583749|NCT03349060|144698382|SUPERIORITY||Difference in LS mean|-0.5||||0.1718|TWO_SIDED|95.0|-1.1|0.2|||Mixed Models Analysis|||Change at Week 2: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||0.2|-1.1|0.1718
72583750|NCT03349060|144698382|SUPERIORITY||Difference in LS mean|-1.1||||0.0018|TWO_SIDED|95.0|-1.7|-0.4|||Mixed Models Analysis|||Change at Week 2: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-0.4|-1.7|0.0018
72583751|NCT03349060|144698382|SUPERIORITY||Difference in LS mean|-1.3||||0.0005|TWO_SIDED|95.0|-2.0|-0.6|||Mixed Models Analysis|||Change at Week 4: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-0.6|-2.0|0.0005
72583752|NCT03349060|144698382|SUPERIORITY||Difference in LS mean|-1.8|||<|0.0001|TWO_SIDED|95.0|-2.5|-1.1|||Mixed Models Analysis|||Change at Week 4: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-1.1|-2.5|<0.0001
72583753|NCT03349060|144698382|SUPERIORITY||Difference in LS mean|-0.7||||0.0476|TWO_SIDED|95.0|-1.5|0.0|||Mixed Models Analysis|||Change at Week 8: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-0.0|-1.5|0.0476
72583754|NCT03349060|144698382|SUPERIORITY||Difference in LS mean|-1.7|||<|0.0001|TWO_SIDED|95.0|-2.4|-1.0|||Mixed Models Analysis|||Change at Week 8: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-1.0|-2.4|<0.0001
72583755|NCT03349060|144698382|SUPERIORITY||Difference in LS mean|-1.1||||0.0028|TWO_SIDED|95.0|-1.9|-0.4|||Mixed Models Analysis|||Change at Week 12: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-0.4|-1.9|0.0028
72583756|NCT03349060|144698382|SUPERIORITY||Difference in LS mean|-1.6|||<|0.0001|TWO_SIDED|95.0|-2.3|-0.9|||Mixed Models Analysis|||Change at Week 12: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-0.9|-2.3|<0.0001
72583757|NCT03349060|144698383|SUPERIORITY||Difference in LS mean|-0.2||||0.6134|TWO_SIDED|95.0|-0.9|0.5|||Mixed Models Analysis|||Change at Week 2: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||0.5|-0.9|0.6134
72583758|NCT03349060|144698383|SUPERIORITY||Difference in LS mean|-0.7||||0.0422|TWO_SIDED|95.0|-1.4|0.0|||Mixed Models Analysis|||Change at Week 2: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-0.0|-1.4|0.0422
72552867|NCT01124175|144636746|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level.|Ratio of the T/R geometric mean x 100|111.95|||||TWO_SIDED|90.0|101.84|123.06|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||123.06|101.84|
72552868|NCT01124175|144636747|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level.|Ratio of the T/R geometric mean x 100|105.97|||||TWO_SIDED|90.0|103.61|108.39|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||108.39|103.61|
72552869|NCT01124175|144636748|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level.|Ratio of the T/R geometric mean x 100|105.67|||||TWO_SIDED|90.0|103.32|108.07|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||108.07|103.32|
72552870|NCT01124175|144636749|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level.|Ratio of the T/R geometric mean x 100|105.97|||||TWO_SIDED|90.0|101.22|110.93|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||110.93|101.22|
72552871|NCT01124175|144636750|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level.|Ratio of the T/R geometric mean x 100|103.07|||||TWO_SIDED|90.0|100.9|105.28|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||105.28|100.90|
72552872|NCT01124175|144636751|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level.|Ratio of the T/R geometric mean x 100|102.36|||||TWO_SIDED|90.0|100.41|104.34|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||104.34|100.41|
72552873|NCT00486863|144636752|SUPERIORITY_OR_OTHER|||||||0.988||||||The p-value is not adjusted for multiple comparisons. The a priori threshold for statistical significance is 0.05.|t-test, 2 sided|||||||0.988
72552874|NCT00486863|144636753|SUPERIORITY_OR_OTHER||||||>|0.999||||||The p-value is not adjusted for multiple comparisons. The a priori threshold for statistical significance is 0.05.|Chi-squared|||||||>0.999
72552875|NCT00486863|144636754|SUPERIORITY_OR_OTHER|||||||0.926||||||The p-value is not adjusted for multiple comparisons. The a priori threshold for statistical significance is 0.05.|t-test, 2 sided|||||||0.926
72552876|NCT00486863|144636755|SUPERIORITY_OR_OTHER|||||||0.502||||||The p-value is not adjusted for multiple comparisons. The a priori threshold for statistical significance is 0.05.|Wilcoxon (Mann-Whitney)|||||||0.502
72552877|NCT00486863|144636756|SUPERIORITY_OR_OTHER|||||||0.439||||||The p-value is not adjusted for multiple comparisons. The a priori threshold for statistical significance is 0.05.|Wilcoxon (Mann-Whitney)|||||||0.439
72552878|NCT00486863|144636757|SUPERIORITY_OR_OTHER|||||||0.704||||||The p-value is not adjusted for multiple comparisons. The a priori threshold for statistical significance is 0.05.|t-test, 2 sided|||||||0.704
72552879|NCT00486863|144636758|SUPERIORITY_OR_OTHER|||||||0.517||||||The p-value is not adjusted for multiple comparisons. The a priori threshold for statistical significance is 0.05.|t-test, 2 sided|||||||0.517
72583759|NCT03349060|144698383|SUPERIORITY||Difference in LS mean|-0.5||||0.205|TWO_SIDED|95.0|-1.2|0.3|||Mixed Models Analysis|||Change at Week 4: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||0.3|-1.2|0.2050
72583760|NCT03349060|144698383|SUPERIORITY||Difference in LS mean|-1.2||||0.0012|TWO_SIDED|95.0|-1.9|-0.5|||Mixed Models Analysis|||Change at Week 4: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-0.5|-1.9|0.0012
72583761|NCT03349060|144698383|SUPERIORITY||Difference in LS mean|-0.4||||0.2657|TWO_SIDED|95.0|-1.2|0.3|||Mixed Models Analysis|||Change at Week 8: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||0.3|-1.2|0.2657
72552880|NCT00486863|144636759|SUPERIORITY_OR_OTHER|||||||0.524||||||The p-value is not adjusted for multiple comparisons. The a priori threshold for statistical significance is 0.05.|Wilcoxon (Mann-Whitney)|||Analysis included the transferrin receptor: ferritin ratio from the cord blood.||||0.524
72552881|NCT00486863|144636759|SUPERIORITY_OR_OTHER|||||||0.07||||||The p-value is not adjusted for multiple comparisons. The a priori threshold for statistical significance is 0.05.|Wilcoxon (Mann-Whitney)|||Analysis included the transferrin receptor: ferritin ratio from the heel stick.||||0.070
72552882|NCT00486863|144636760|SUPERIORITY_OR_OTHER||||||<|0.001||||||The p-value is not adjusted for multiple comparisons. The a priori threshold for statistical significance is 0.05.|Chi-squared|||||||<0.001
72552883|NCT00486863|144636765|SUPERIORITY_OR_OTHER|||||||0.991||||||The p-value is not adjusted for multiple comparisons. The a priori threshold for statistical significance is 0.05.|Chi-squared|||||||0.991
72552884|NCT00355797|144636772|SUPERIORITY_OR_OTHER||Mean Difference (Net)|9.17|STANDARD_DEVIATION|15.9||0.004|TWO_SIDED|95.0|3.24|15.11|||t-test, 2 sided|||The endpoint will compare the composite percent change in ADL performance for patients while their devices are programmed to CLS and accelerometer pacing modes, using the no rate adaptive pacing mode as the baseline. Null hypothesis: mean composite of percent change for patients with their device programmed to CLS is less than or equal to the mean composite of percent change for the same patients with their device in accelerometer.||15.11|3.24|0.004
72413106|NCT02508480|144334860|SUPERIORITY|||||||0.135||||||The p-value above is for the overall group effect.|Mixed Models Analysis|||The two study arms were compared using mixed models analysis controlling for baseline scores. Variables included in the model were- baseline score, group, time, and group by time interaction.||||0.135
72413107|NCT02508480|144334861|SUPERIORITY|||||||0.25||||||The p-value above represents the overall group effect.|Mixed Models Analysis|||The two study arms were compared on the interpersonal function subscale using mixed models analysis controlling for baseline scores. Variables included in the model were- baseline score, group, time, and group by time interaction.||||0.25
72413108|NCT02508480|144334861|SUPERIORITY|||||||0.118||||||The p-value represents the overall group effect.|Mixed Models Analysis|||The two study arms were compared on the intrapsychic foundations subscale using mixed models analysis controlling for baseline scores. Variables included in the model were- baseline score, group, time, and group by time interaction.||||0.118
72413109|NCT02508480|144334862|SUPERIORITY|||||||0.917||||||The p-value is for group effect for tcpm\_days\_participated.|Mixed Models Analysis|||The two study arms were compared using mixed models analysis controlling for baseline scores. Variables included in the model were- baseline score, group, time, and group by time interaction. The p-value reported below is for group effect for tcpm\_days\_participated.||||0.917
72413110|NCT02508480|144334863|SUPERIORITY|||||||0.017||||||The p-value above is for the overall group effect.|Mixed Models Analysis|||The two study arms were compared using mixed models analysis controlling for baseline scores. Variables included in the model were- baseline score, group, time, and group by time interaction.||||0.017
72413111|NCT02508480|144334864|SUPERIORITY|||||||0.597||||||The p-value above represents the overall group effect.|Mixed Models Analysis|||The two study arms were compared using mixed models analysis controlling for baseline scores. Variables included in the model were- baseline score, group, time, and group by time interaction.||||0.597
72413112|NCT02508480|144334865|SUPERIORITY|||||||0.076||||||The p-value above represents the overall group effect.|Mixed Models Analysis|||The two study arms were compared using mixed models analysis controlling for baseline scores. Variables included in the model were- baseline score, group, time, and group by time interaction.||||0.076
72413113|NCT02508480|144334866|SUPERIORITY|||||||0.978||||||The p-value above represents the overall group effect.|Mixed Models Analysis|||The two study arms were compared using mixed models analysis controlling for baseline scores. Variables included in the model were- baseline score, group, time, and group by time interaction.||||0.978
72413114|NCT00304070|144334883|OTHER||2 Year EFS|0.89||||0.44|TWO_SIDED|95.0|||||2-year KM estimate|||We will test the 2-year EFS is 90% using the asymptotic distribution of the complementary log-log distribution of the Kaplan-Meier (KM) estimate.||||0.44
72413115|NCT00304070|144334883|OTHER||2 Year EFS|0.53||||0.4|TWO_SIDED|95.0|||||2-year KM estimate|||We will test the 2-year EFS is 50% using the asymptotic distribution of the complementary log-log distribution of the Kaplan-Meier (KM) estimate.||||0.40
72413116|NCT00304070|144334883|OTHER||2 Year EFS|0.55||||8.53e-06|TWO_SIDED|95.0|||||2-year KM estimate|||We will test the 2-year EFS is 15% using the asymptotic distribution of the complementary log-log distribution of the Kaplan-Meier (KM) estimate.||||0.00000853
72413117|NCT00320216|144334890|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel chi square test|Stratified by baseline weight \[\<=90kg vs \> 90 kg\].||||||<0.001
72551156|NCT01029353|144632563|SUPERIORITY|||||||||||||||||A Bayesian analysis. Initial Laparotomy and Initial Peritoneal Drain were compared using a hierarchical linear regression. The SAS procedure PROC MCMC with reference cell coding was used. Center (random effect), treatment, pre-operative diagnosis, and baseline risk of death or NDI were binary covariates. Pre-operative diagnosis levels were NEC and IP. Markov chain Monte Carlo (MCMC) characteristics: three chains, 10000 tunings, 10000 burn-ins, 1000000 samples, thinning=20.|Priors for model parameters: intercept = Normal(mean=0, variance=1000), treatment, baseline risk, and preop diagnosis parameters = Normal(mean=0, variance=10), random effect standard deviation = Half-Normal(mean=0, variance=10). The posterior median difference Initial Laparotomy minus Initial Drainage was -1.78, 95% credible interval of (-7.44, 3.87).|||
72551157|NCT01029353|144632564|SUPERIORITY||Risk Ratio (RR)|0.81|||||TWO_SIDED|95.0|0.64|1.04|||||The model was fit using PROC GENMOD in SAS, using center as the repeated effect. Effect coding was used to represent the binary covariates.|This by treatment and by pre-operative diagnosis secondary analysis was completed by using a robust Poisson regression model, with log link and center as repeated measure. Model included treatment, baseline risk of death or NDI, pre-op diagnosis (NEC/IP), and treatment by pre-op diagnosis as covariates. Reported results in this analysis restricted to model based treatment effect estimate (laparotomy over drain) when pre-operative diagnosis is equal to NEC.||1.04|0.64|
72551158|NCT01029353|144632564|SUPERIORITY||Risk Ratio (RR)|1.11|||||TWO_SIDED|95.0|0.95|1.31|||||The model was fit using PROC GENMOD in SAS, using center as the repeated effect. Effect coding was used to represent the binary covariates.|This by treatment and by pre-operative diagnosis secondary analysis was completed by using a robust Poisson regression model, with log link and center as repeated measure. Model included treatment, baseline risk of death or NDI, pre-op diagnosis (NEC/IP), and treatment by pre-op diagnosis as covariates. Reported results in this analysis restricted to model based treatment effect estimate (laparotomy over drain) when pre-operative diagnosis is equal to IP.||1.31|0.95|
72551159|NCT01029353|144632564|SUPERIORITY|||||||||||||||||A Bayesian analysis. Within pre-operative diagnosis, Initial Laparotomy and Initial Peritoneal Drain were compared using log-binomial regression. Pre-operative diagnosis levels were NEC and IP. PROC MCMC with effect coding was used. Center (random effect), treatment, pre-operative diagnosis, baseline risk, and the treatment by Preoperative diagnosis were the covariates. Markov chain Monte Carlo (MCMC) characteristics: three chains, 10000 tunings, 10000 burn-ins, 1000000 samples, thinning=20.|Priors for model parameters: intercept = Normal(mean=0, variance=100), baseline risk and preop diagnosis parameters = Normal(mean=0, variance=1), treatment and the interaction term = Normal(mean=0, variance=0.31416), random effect standard deviation = Half-Normal(mean=0, variance=10). For the NEC pre-operative diagnosis, the posterior median relative risk of Initial Laparotomy over Initial Drainage was 0.81, 95% credible interval of (0.63, 1.00). For the IP pre-operative diagnosis, the posterior median relative risk of Initial Laparotomy over Initial Drainage was 1.09, 95% credible interval of (0.90, 1.33).|||
72413118|NCT00320216|144334890|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel (CMH) chi square|Stratified by baseline weight \[≤ 90kg vs \> 90 kg)\].||||||<0.001
72413119|NCT00320216|144334890|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel (CMH) chi square|Stratified by baseline weight \[≤ 90kg vs \> 90 kg)\].||||||<0.001
72421537|NCT01181726|144354220|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|95.19|||||TWO_SIDED|90.0|91.18|99.38|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||99.38|91.18|
72413120|NCT00320216|144334890|SUPERIORITY_OR_OTHER||||||<|0.01||95.0||||To control for the multiplicity for the primary endpoint analysis, the 4 pairwise comparisons between ustekinumab groups and placebo were performed sequentially at alpha = 0.05. The order of testing was prespecified from high to low doses.|Cochran-Mantel-Haenszel (CMH) chi square|Stratified by baseline weight \[≤ 90kg vs \> 90 kg)\].||Null Hypothesis:No difference between any ustekinumab group and placebo at an overall significant level of 0.05. Sample Size: With 300 participants (60 in each treatment group), simulation studies were conducted to calculate the power to detect a treatment difference in primary endpoint between ustekinumab groups and placebo using a CMH test with stratification by baseline weight \[≤ 90kg vs \> 90 kg). For all the scenarios evaluated, the power is \>99% at an overall significance level of 0.05.||||<0.01
72413121|NCT00320216|144334891|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel (CMH) chi square|Stratified by baseline weight \[≤ 90kg vs \> 90 kg)\].||||||<0.001
72413122|NCT00320216|144334891|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel (CMH) chi square|Stratified by baseline weight \[≤ 90kg vs \> 90 kg)\].||||||<0.001
72551160|NCT01029353|144632565|SUPERIORITY||Risk Ratio (RR)|0.77|||||TWO_SIDED|95.0|0.52|1.13|||||The model was fit using PROC GENMOD in SAS, using center as the repeated effect. Effect coding was used to represent the binary covariates.|This by treatment and by pre-operative diagnosis secondary analysis was completed by using a robust Poisson regression model, with log link and center as repeated measure. Model included treatment, baseline risk of death or NDI, pre-op diagnosis (NEC/IP), and treatment by pre-op diagnosis as covariates. Reported results in this analysis restricted to model based treatment effect estimate (laparotomy over drain) when pre-operative diagnosis is equal to NEC.||1.13|0.52|
72551161|NCT01029353|144632565|SUPERIORITY||Risk Ratio (RR)|1.28|||||TWO_SIDED|95.0|0.79|2.06|||||The model was fit using PROC GENMOD in SAS, using center as the repeated effect. Effect coding was used to represent the binary covariates.|This by treatment and by pre-operative diagnosis secondary analysis was completed by using a robust Poisson regression model, with log link and center as repeated measure. Model included treatment, baseline risk of death or NDI, pre-op diagnosis (NEC/IP), and treatment by pre-op diagnosis as covariates. Reported results in this analysis restricted to model based treatment effect estimate (laparotomy over drain) when pre-operative diagnosis is equal to IP.||2.06|0.79|
72551162|NCT01029353|144632565|SUPERIORITY|||||||||||||||||A Bayesian analysis. Within pre-operative diagnosis, Initial Laparotomy and Initial Peritoneal Drain were compared using log-binomial regression. Pre-operative diagnosis levels were NEC and IP. PROC MCMC with effect coding was used. Center (random effect), treatment, pre-operative diagnosis, baseline risk, and the treatment by Preoperative diagnosis were the covariates. Markov chain Monte Carlo (MCMC) characteristics: three chains, 10000 tunings, 10000 burn-ins, 1000000 samples, thinning=20.|Priors for model parameters: intercept = Normal(mean=0, variance=100), baseline risk and preop diagnosis parameters = Normal(mean=0, variance=1), treatment and the interaction term = Normal(mean=0, variance=0.31416), random effect standard deviation = Half-Normal(mean=0, variance=10). For the NEC pre-operative diagnosis, the posterior median relative risk of Initial Laparotomy over Initial Drainage was 0.82, 95% credible interval of (0.53, 1.20). For the IP pre-operative diagnosis, the posterior median relative risk of Initial Laparotomy over Initial Drainage was 1.18, 95% credible interval of (0.74, 1.87).|||
72551163|NCT01029353|144632566|SUPERIORITY||Risk Ratio (RR)|0.73|||||TWO_SIDED|95.0|0.42|1.27|||||The model was fit using PROC GENMOD in SAS, using center as the repeated effect. Effect coding was used to represent the binary covariates.|This by treatment and by pre-operative diagnosis secondary analysis was completed by using a robust Poisson regression model, with log link and center as repeated measure. Model included treatment, baseline risk of death or NDI, pre-op diagnosis (NEC/IP), and treatment by pre-op diagnosis as covariates. Reported results in this analysis restricted to model based treatment effect estimate (laparotomy over drain) when pre-operative diagnosis is equal to NEC.||1.27|0.42|
72551164|NCT01029353|144632566|SUPERIORITY||Risk Ratio (RR)|1.11|||||TWO_SIDED|95.0|0.85|1.45|||||The model was fit using PROC GENMOD in SAS, using center as the repeated effect. Effect coding was used to represent the binary covariates.|This by treatment and by pre-operative diagnosis secondary analysis was completed by using a robust Poisson regression model, with log link and center as repeated measure. Model included treatment, baseline risk of death or NDI, pre-op diagnosis (NEC/IP), and treatment by pre-op diagnosis as covariates. Reported results in this analysis restricted to model based treatment effect estimate (laparotomy over drain) when pre-operative diagnosis is equal to IP.||1.45|0.85|
72552885|NCT00355797|144636779|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-1.42|STANDARD_DEVIATION|17.74||0.552|TWO_SIDED|95.0|-6.17|3.33|||t-test, 2 sided|||The purpose of endpoint was to evaluate the percent change in pulse pressure during test. The null hypothesis was the mean percent change for patients with their device programmed to CLS is greater or equal to the mean percent change for the same patients with their device in accelerometer.||3.33|-6.17|0.552
72583762|NCT03349060|144698383|SUPERIORITY||Difference in LS mean|-1.2||||0.0019|TWO_SIDED|95.0|-2.0|-0.5|||Mixed Models Analysis|||Change at Week 8: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-0.5|-2.0|0.0019
72583763|NCT03349060|144698383|SUPERIORITY||Difference in LS mean|-0.5||||0.1675|TWO_SIDED|95.0|-1.3|0.2|||Mixed Models Analysis|||Change at Week 12: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||0.2|-1.3|0.1675
72413123|NCT00320216|144334891|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel (CMH) chi square|||||||<0.001
72551165|NCT01029353|144632566|SUPERIORITY|||||||||||||||||A Bayesian analysis. Within pre-operative diagnosis, Initial Laparotomy and Initial Peritoneal Drain were compared using log-binomial regression. Pre-operative diagnosis levels were NEC and IP. PROC MCMC with effect coding was used. Center (random effect), treatment, pre-operative diagnosis, baseline risk, and the treatment by Pre-operative diagnosis were the covariates. Markov chain Monte Carlo (MCMC) characteristics: three chains, 10000 tunings, 10000 burn-ins, 1000000 samples, thinning=20.|Priors for model parameters: intercept = Normal(mean=0, variance=100), baseline risk and preop diagnosis parameters = Normal(mean=0, variance=1), treatment and the interaction term = Normal(mean=0, variance=0.31416), random effect standard deviation = Half-Normal(mean=0, variance=10). For the NEC pre-operative diagnosis, the posterior median relative risk of Initial Laparotomy over Initial Drainage was 0.76, 95% credible interval of (0.48, 1.18). For the IP pre-operative diagnosis, the posterior median relative risk of Initial Laparotomy over Initial Drainage was 1.08, 95% credible interval of (0.83, 1.42).|||
72583764|NCT03349060|144698383|SUPERIORITY||Difference in LS mean|-1.0||||0.0085|TWO_SIDED|95.0|-1.8|-0.3|||Mixed Models Analysis|||Change at Week 12: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-0.3|-1.8|0.0085
72583765|NCT03349060|144698384|SUPERIORITY||Difference in Percentage|8.8||||0.5539|TWO_SIDED|95.0|-19.6|37.2||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||37.2|-19.6|0.5539
72583766|NCT03349060|144698384|SUPERIORITY||Difference in Percentage|27.9||||0.0561|TWO_SIDED|95.0|0.8|55.1||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||55.1|0.8|0.0561
72583767|NCT03349060|144698384|SUPERIORITY||Difference in Percentage|-4.9||||0.746|TWO_SIDED|95.0|-33.4|23.7||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||23.7|-33.4|0.7460
72583768|NCT03349060|144698384|SUPERIORITY||Difference in Percentage|0.0||||1|TWO_SIDED|95.0|-28.3|28.3||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||28.3|-28.3|1.0000
72583769|NCT03349060|144698384|SUPERIORITY||Difference in Percentage|20.8||||0.1474|TWO_SIDED|95.0|-4.5|46.2||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||46.2|-4.5|0.1474
72583770|NCT03349060|144698384|SUPERIORITY||Difference in Percentage|37.3||||0.0123|TWO_SIDED|95.0|12.1|62.5||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||62.5|12.1|0.0123
72583771|NCT03349060|144698384|SUPERIORITY||Difference in Percentage|-0.4||||0.976|TWO_SIDED|95.0|-28.5|27.6||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||27.6|-28.5|0.9760
72583772|NCT03349060|144698384|SUPERIORITY||Difference in Percentage|7.8||||0.5965|TWO_SIDED|95.0|-20.4|36.1||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||36.1|-20.4|0.5965
72583773|NCT03349060|144698385|SUPERIORITY||Difference in Percentage|24.0||||0.2278|TWO_SIDED|95.0|-9.9|58.0||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||58.0|-9.9|0.2278
72583774|NCT03349060|144698385|SUPERIORITY||Difference in Percentage|35.2||||0.0996|TWO_SIDED|95.0|-2.0|72.4||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||72.4|-2.0|0.0996
72583775|NCT03349060|144698385|SUPERIORITY||Difference in Percentage|14.5||||0.4449|TWO_SIDED|95.0|-21.6|50.6||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||50.6|-21.6|0.4449
72551166|NCT01029353|144632567|SUPERIORITY||Risk Ratio (RR)|0.7|||||TWO_SIDED|95.0|0.47|1.05|||||The model was fit using PROC GENMOD in SAS, using center as the repeated effect. Effect coding was used to represent the binary covariates.|This by treatment and by pre-operative diagnosis secondary analysis was completed by using a robust Poisson regression model, with log link and center as repeated measure. Model included treatment, baseline risk of death or NDI, pre-op diagnosis (NEC/IP), and treatment by pre-op diagnosis as covariates. Reported results in this analysis restricted to model based treatment effect estimate (laparotomy over drain) when pre-operative diagnosis is equal to NEC.||1.05|0.47|
72551167|NCT01029353|144632567|SUPERIORITY||Risk Ratio (RR)|0.95|||||TWO_SIDED|95.0|0.76|1.19|||||The model was fit using PROC GENMOD in SAS, using center as the repeated effect. Effect coding was used to represent the binary covariates.|This by treatment and by pre-operative diagnosis secondary analysis was completed by using a robust Poisson regression model, with log link and center as repeated measure. Model included treatment, baseline risk of death or NDI, pre-op diagnosis (NEC/IP), and treatment by pre-op diagnosis as covariates. Reported results in this analysis restricted to model based treatment effect estimate (laparotomy over drain) when pre-operative diagnosis is equal to IP.||1.19|0.76|
72551168|NCT01029353|144632567|SUPERIORITY|||||||||||||||||A Bayesian analysis. Within pre-operative diagnosis, Initial Laparotomy and Initial Peritoneal Drain were compared using log-binomial regression. Pre-operative diagnosis levels were NEC and IP. PROC MCMC with effect coding was used. Center (random effect), treatment, pre-operative diagnosis, baseline risk, and the treatment by Preoperative diagnosis were the covariates. Markov chain Monte Carlo (MCMC) characteristics: three chains, 10000 tunings, 10000 burn-ins, 1000000 samples, thinning=20.|Priors for model parameters: intercept = Normal(mean=0, variance=100), baseline risk and preop diagnosis parameters = Normal(mean=0, variance=1), treatment and the interaction term = Normal(mean=0, variance=0.31416), random effect standard deviation = Half-Normal(mean=0, variance=10). For the NEC pre-operative diagnosis, the posterior median relative risk of Initial Laparotomy over Initial Drainage was 0.73, 95% credible interval of (0.52, 0.96). For the IP pre-operative diagnosis, the posterior median relative risk of Initial Laparotomy over Initial Drainage was 0.95, 95% credible interval of (0.68, 1.32).|||
72551169|NCT01029353|144632568|SUPERIORITY||Risk Ratio (RR)|0.81|||||TWO_SIDED|95.0|0.61|1.06|||||The model was fit using PROC GENMOD in SAS, using center as the repeated effect. Effect coding was used to represent the binary covariates.|This by treatment and by pre-operative diagnosis secondary analysis was completed by using a robust Poisson regression model, with log link and center as repeated measure. Model included treatment, baseline risk of death or NDI, pre-op diagnosis (NEC/IP), and treatment by pre-op diagnosis as covariates. Reported results in this analysis restricted to model based treatment effect estimate (laparotomy over drain) when pre-operative diagnosis is equal to NEC.||1.06|0.61|
72551170|NCT01029353|144632568|SUPERIORITY||Risk Ratio (RR)|1.17|||||TWO_SIDED|95.0|1.01|1.37|||||The model was fit using PROC GENMOD in SAS, using center as the repeated effect. Effect coding was used to represent the binary covariates.|This by treatment and by pre-operative diagnosis secondary analysis was completed by using a robust Poisson regression model, with log link and center as repeated measure. Model included treatment, baseline risk of death or NDI, pre-op diagnosis (NEC/IP), and treatment by pre-op diagnosis as covariates. Reported results in this analysis restricted to model based treatment effect estimate (laparotomy over drain) when pre-operative diagnosis is equal to IP.||1.37|1.01|
72551171|NCT01029353|144632568|SUPERIORITY|||||||||||||||||A Bayesian analysis. Within pre-operative diagnosis, Initial Laparotomy and Initial Peritoneal Drain were compared using log-binomial regression. Pre-operative diagnosis levels were NEC and IP. PROC MCMC with effect coding was used. Center (random effect), treatment, pre-operative diagnosis, baseline risk, and the treatment by Preoperative diagnosis were the covariates. Markov chain Monte Carlo (MCMC) characteristics: three chains, 10000 tunings, 10000 burn-ins, 1000000 samples, thinning=20.|Priors for model parameters: intercept = Normal(mean=0, variance=100), baseline risk and preop diagnosis parameters = Normal(mean=0, variance=1), treatment and the interaction term = Normal(mean=0, variance=0.31416), random effect standard deviation = Half-Normal(mean=0, variance=10). For the NEC pre-operative diagnosis, the posterior median relative risk of Initial Laparotomy over Initial Drainage was 0.80, 95% credible interval of (0.61, 1.01). For the IP pre-operative diagnosis, the posterior median relative risk of Initial Laparotomy over Initial Drainage was 1.15, 95% credible interval of (0.94, 1.42).|||
72551172|NCT01029353|144632569|SUPERIORITY||Risk Ratio (RR)|0.68|||||TWO_SIDED|95.0|0.46|1.01|||||The model was fit using PROC GENMOD in SAS, using center as the repeated effect. Effect coding was used to represent the binary covariates.|This by treatment and by pre-operative diagnosis secondary analysis was completed by using a robust Poisson regression model, with log link and center as repeated measure. Model included treatment, baseline risk of death or NDI, pre-op diagnosis (NEC/IP), and treatment by pre-op diagnosis as covariates. Reported results in this analysis restricted to model based treatment effect estimate (laparotomy over drain) when pre-operative diagnosis is equal to NEC.||1.01|0.46|
72551173|NCT01029353|144632569|SUPERIORITY||Risk Ratio (RR)|1.22|||||TWO_SIDED|95.0|0.74|2.01|||||The model was fit using PROC GENMOD in SAS, using center as the repeated effect. Effect coding was used to represent the binary covariates.|This by treatment and by pre-operative diagnosis secondary analysis was completed by using a robust Poisson regression model, with log link and center as repeated measure. Model included treatment, baseline risk of death or NDI, pre-op diagnosis (NEC/IP), and treatment by pre-op diagnosis as covariates. Reported results in this analysis restricted to model based treatment effect estimate (laparotomy over drain) when pre-operative diagnosis is equal to IP.||2.01|0.74|
72551174|NCT01029353|144632569|SUPERIORITY|||||||||||||||||A Bayesian analysis. Within pre-operative diagnosis, Initial Laparotomy and Initial Peritoneal Drain were compared using log-binomial regression. Pre-operative diagnosis levels were NEC and IP. PROC MCMC with effect coding was used. Center (random effect), treatment, pre-operative diagnosis, baseline risk, and the treatment by Preoperative diagnosis were the covariates. Markov chain Monte Carlo (MCMC) characteristics: three chains, 10000 tunings, 10000 burn-ins, 1000000 samples, thinning=20.|Priors for model parameters: intercept = Normal(mean=0, variance=100), baseline risk and preop diagnosis parameters = Normal(mean=0, variance=1), treatment and the interaction term = Normal(mean=0, variance=0.31416), random effect standard deviation = Half-Normal(mean=0, variance=10). For the NEC pre-operative diagnosis, the posterior median relative risk of Initial Laparotomy over Initial Drainage was 0.72, 95% credible interval of (0.48, 1.05). For the IP pre-operative diagnosis, the posterior median relative risk of Initial Laparotomy over Initial Drainage was 1.12, 95% credible interval of (0.71, 1.76).|||
72583776|NCT03349060|144698385|SUPERIORITY||Difference in Percentage|16.9||||0.4139|TWO_SIDED|95.0|-21.6|55.5||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||55.5|-21.6|0.4139
72551175|NCT01029353|144632570|SUPERIORITY||Risk Ratio (RR)|0.73|||||TWO_SIDED|95.0|0.51|1.04|||||The model was fit using PROC GENMOD in SAS, using center as the repeated effect. Effect coding was used to represent the binary covariates.|This by treatment and by pre-operative diagnosis secondary analysis was completed by using a robust Poisson regression model, with log link and center as repeated measure. Model included treatment, baseline risk of death or NDI, pre-op diagnosis (NEC/IP), and treatment by pre-op diagnosis as covariates. Reported results in this analysis restricted to model based treatment effect estimate (laparotomy over drain) when pre-operative diagnosis is equal to NEC.||1.04|0.51|
72551176|NCT01029353|144632570|SUPERIORITY||Risk Ratio (RR)|1.25|||||TWO_SIDED|95.0|0.82|1.93|||||The model was fit using PROC GENMOD in SAS, using center as the repeated effect. Effect coding was used to represent the binary covariates. Reported results in this analysis restricted to infants with IP.|This by treatment and by pre-operative diagnosis secondary analysis was completed by using a robust Poisson regression model, with log link and center as repeated measure. Model included treatment, baseline risk of death or NDI, pre-op diagnosis (NEC/IP), and treatment by pre-op diagnosis as covariates. Reported results in this analysis restricted to model based treatment effect estimate (laparotomy over drain) when pre-operative diagnosis is equal to IP.||1.93|0.82|
72552886|NCT00355797|144636779|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|1.91|STANDARD_DEVIATION|21.34||0.505|TWO_SIDED|95.0|-3.8|7.63|||t-test, 2 sided|||The purpose of endpoint was to evaluate the percent change in pulse pressure during test. The null hypothesis was the mean percent change for patients with their device programmed to CLS is greater or equal to the mean percent change for the same patients with their device without rate adaptative pacing.||7.63|-3.80|0.505
72552887|NCT02028715|144636816|SUPERIORITY||Mean Difference (Final Values)|5.55501|STANDARD_ERROR_OF_MEAN|5.96535||0.356|TWO_SIDED|95.0|-6.3904|17.50042|||t-test for Equality of Means|||||17.50042|-6.39040|.356
72552888|NCT02028715|144636817|SUPERIORITY||Median Difference (Final Values)|11.51818|STANDARD_ERROR_OF_MEAN|6.98569||0.105|TWO_SIDED|95.0|-2.49963|25.53599|||t-test for Equality of Means|||||25.53599|-2.49963|.105
72413124|NCT00320216|144334891|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel (CMH) chi square|Stratified by baseline weight \[≤ 90kg vs \> 90 kg)\].||Null Hypothesis: No difference between any ustekinumab group and placebo.||||<0.001
72552889|NCT02028715|144636818|SUPERIORITY|||||||0.029|||||||ANOVA|||||||.029
72552890|NCT02028715|144636819|SUPERIORITY|Within subjects Analysis of Variance (ANOVA) of time, sphericity assumed, was used for pain, nausea, bloating and pruritus.||||||0.643|||||||ANOVA|||||||.643
72552891|NCT02028715|144636820|SUPERIORITY|Within subjects Analysis of Variance (ANOVA) of time, sphericity assumed, was used for pain, nausea, bloating and pruritus.||||||0.217|||||||ANOVA|||||||.217
72552892|NCT02028715|144636821|SUPERIORITY|Within subjects Analysis of Variance (ANOVA) of time, sphericity assumed, was used for pain, nausea, bloating and pruritus.||||||0.647|||||||ANOVA|||||||.647
72552893|NCT02028715|144636822|SUPERIORITY||Mean Difference (Final Values)|0.054|STANDARD_ERROR_OF_MEAN|0.32|||TWO_SIDED|95.0|-0.587|0.695||||||||.695|-.587|
72552894|NCT02883452|144636824|NON_INFERIORITY|The non-inferiority of CT-P13 SC to CT-P13 IV was to be concluded if the lower bound of two-sided 90% CI for the ratio of geometric least square means was higher than 80%.|Ratio of Geometric LS means|1154.17|||||TWO_SIDED|90.0|786.37|1694.0|||||The geometric lease square (LS) means, ratio of geometric LS means (CT-P13 SC 120/240 mg to CT-P13 IV 5 mg/kg), and 2-sided 90% CI were obtained from the ANCOVA model.|Primary PK analysis was analyzed using an ANCOVA with treatment as fixed effect and current use of treatment with azathioprine (AZA) or 6-mercaptopurine (6-MP) or methotrexate (MTX) (used or not used), disease (CD or UC), clinical response at Week 6 (responder or non-responder by Clinical Disease Activity Index \[CDAI\]-70 for CD or partial Mayo score for UC), body weight at Week 6 (\<80 kg or ≥80 kg) fitted as covariates.||1694.00|786.37|
72552895|NCT00830206|144636831|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|An analysis of variance (ANOVA) was performed on the pharmacokinetic parameters using SAS® Software.|Geometric Test/Ref Ratio x 100|102.62||||||90.0|94.84|111.05|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||111.05|94.84|
72552896|NCT00830206|144636832|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|An analysis of variance (ANOVA) was performed on the pharmacokinetic parameters using SAS® software.|Geometric Test/Ref Ratio x 100|100.85||||||90.0|94.48|107.65|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||107.65|94.48|
72413125|NCT00377676|144334898|NON_INFERIORITY_OR_EQUIVALENCE|In order to test the primary hypothesis at a one-sided alpha = .05 and have a power of 0.9, when the non-inferiority margin is 1.5, the total number of subjects with all-cause SAEs that must be observed during the study was found to be 235. Assuming the placebo rate is 0.08, the required sample size was found to be 2991.|Hazard Ratio (HR)|1.02|||<|0.05|ONE_SIDED|95.0||1.27||Using the Lan and Demets alpha spending function for O'Brien-Fleming boundaries and the overall one-sided significance level of 5%, a level of 0.04068 was to be used at the interim analysis and 0.03938 at the time of the final analysis.|Regression, Cox||cycloset to placebo|||1.27||<0.05
72551177|NCT01029353|144632570|SUPERIORITY|||||||||||||||||A Bayesian analysis. Within pre-operative diagnosis, Initial Laparotomy and Initial Peritoneal Drain were compared using log-binomial regression. Pre-operative diagnosis levels were NEC and IP. PROC MCMC with effect coding was used. Center (random effect), treatment, pre-operative diagnosis, baseline risk, and the treatment by Preoperative diagnosis were the covariates. Markov chain Monte Carlo (MCMC) characteristics: three chains, 10000 tunings, 10000 burn-ins, 1000000 samples, thinning=20.|Priors for model parameters: intercept = Normal(mean=0, variance=100), baseline risk and preop diagnosis parameters = Normal(mean=0, variance=1), treatment and the interaction term = Normal(mean=0, variance=0.31416), random effect standard deviation = Half-Normal(mean=0, variance=10). For the NEC pre-operative diagnosis, the posterior median relative risk of Initial Laparotomy over Initial Drainage was 0.77, 95% credible interval of (0.51, 1.14). For the IP pre-operative diagnosis, the posterior median relative risk of Initial Laparotomy over Initial Drainage was 1.17, 95% credible interval of (0.76, 1.81).|||
72551178|NCT01029353|144632571|SUPERIORITY||Risk Ratio (RR)|0.53|||||TWO_SIDED|95.0|0.31|0.89|||||The model was fit using PROC GENMOD in SAS, using center as the repeated effect. Effect coding was used to represent the binary covariates.|This by treatment and by pre-operative diagnosis secondary analysis was completed by using a robust Poisson regression model, with log link and center as repeated measure. Model included treatment, baseline risk of death or NDI, pre-op diagnosis (NEC/IP), and treatment by pre-op diagnosis as covariates. Reported results in this analysis restricted to model based treatment effect estimate (laparotomy over drain) when pre-operative diagnosis is equal to NEC.||0.89|0.31|
72583777|NCT03349060|144698385|SUPERIORITY||Difference in Percentage|-6.7||||0.729|TWO_SIDED|95.0|-40.7|27.4||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||27.4|-40.7|0.7290
72583778|NCT03349060|144698385|SUPERIORITY||Difference in Percentage|8.7||||0.6585|TWO_SIDED|95.0|-27.3|44.6||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||44.6|-27.3|0.6585
72551179|NCT01029353|144632571|SUPERIORITY||Risk Ratio (RR)|0.44|||||TWO_SIDED|95.0|0.29|0.66|||||The model was fit using PROC GENMOD in SAS, using center as the repeated effect. Effect coding was used to represent the binary covariates.|This by treatment and by pre-operative diagnosis secondary analysis was completed by using a robust Poisson regression model, with log link and center as repeated measure. Model included treatment, baseline risk of death or NDI, pre-op diagnosis (NEC/IP), and treatment by pre-op diagnosis as covariates. Reported results in this analysis restricted to model based treatment effect estimate (laparotomy over drain) when pre-operative diagnosis is equal to IP.||0.66|0.29|
72551180|NCT01029353|144632572|SUPERIORITY||Risk Ratio (RR)|1.44|||||TWO_SIDED|95.0|0.58|3.57|||||The model was fit using PROC GENMOD in SAS, using center as the repeated effect. Effect coding was used to represent the binary covariates.|This by treatment and by pre-operative diagnosis secondary analysis was completed by using a robust Poisson regression model, with log link and center as repeated measure. Model included treatment, baseline risk of death or NDI, pre-op diagnosis (NEC/IP), and treatment by pre-op diagnosis as covariates. Reported results in this analysis restricted to model based treatment effect estimate (laparotomy over drain) when pre-operative diagnosis is equal to NEC.||3.57|0.58|
72369793|NCT04857320|144249950|SUPERIORITY|||||||0|||||||t-test, 1 sided|Degrees of Freedom = 3||Subject received doses applied to the skin of 0.075, 0.10 and 0.15 IUs / Kilogram on successive days. The Subject's average Serum Glucose for these 3 days were compared against the Subject's baseline unmedicated Serum Glucose on non-dosed days.||||0
72583779|NCT03349060|144698385|SUPERIORITY||Difference in Percentage|18.2||||0.3638|TWO_SIDED|95.0|-18.7|55.1||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||55.1|-18.7|0.3638
72583780|NCT03349060|144698385|SUPERIORITY||Difference in Percentage|40.5||||0.055|TWO_SIDED|95.0|2.4|78.5||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||78.5|2.4|0.0550
72583781|NCT03349060|144698386|SUPERIORITY||Difference in Percentage|-18.8||||0.4036|TWO_SIDED|95.0|-58.4|20.9||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||20.9|-58.4|0.4036
72583782|NCT03349060|144698386|SUPERIORITY||Difference in Percentage|-35.3||||0.158|TWO_SIDED|95.0|-75.9|5.3||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||5.3|-75.9|0.1580
72583783|NCT03349060|144698386|SUPERIORITY||Difference in Percentage|-14.2||||0.514|TWO_SIDED|95.0|-53.5|25.1||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||25.1|-53.5|0.5140
72583784|NCT03349060|144698386|SUPERIORITY||Difference in Percentage|-19.8||||0.4149|TWO_SIDED|95.0|-63.3|23.7||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||23.7|-63.3|0.4149
72583785|NCT03349060|144698386|SUPERIORITY||Difference in Percentage|-18.8||||0.4036|TWO_SIDED|95.0|-58.4|20.9||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||20.9|-58.4|0.4036
72583786|NCT03349060|144698386|SUPERIORITY||Difference in Percentage|-30.7||||0.2092|TWO_SIDED|95.0|-70.9|9.6||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||9.6|-70.9|0.2092
72583787|NCT03349060|144698386|SUPERIORITY||Difference in Percentage|11.9||||0.5982|TWO_SIDED|95.0|-29.1|53.0||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||53.0|-29.1|0.5982
72551181|NCT01029353|144632572|SUPERIORITY||Risk Ratio (RR)|1.63|||||TWO_SIDED|95.0|1.06|2.5|||||The model was fit using PROC GENMOD in SAS, using center as the repeated effect. Effect coding was used to represent the binary covariates.|This by treatment and by pre-operative diagnosis secondary analysis was completed by using a robust Poisson regression model, with log link and center as repeated measure. Model included treatment, baseline risk of death or NDI, pre-op diagnosis (NEC/IP), and treatment by pre-op diagnosis as covariates. Reported results in this analysis restricted to model based treatment effect estimate (laparotomy over drain) when pre-operative diagnosis is equal to IP.||2.50|1.06|
72551182|NCT01029353|144632573|SUPERIORITY||Risk Ratio (RR)|2.52|||||TWO_SIDED|95.0|0.84|7.55|||||The model was fit using PROC GENMOD in SAS, using center as the repeated effect. Effect coding was used to represent the binary covariates.|This by treatment and by pre-operative diagnosis secondary analysis was completed by using a robust Poisson regression model, with log link and center as repeated measure. Model included treatment, baseline risk of death or NDI, pre-op diagnosis (NEC/IP), and treatment by pre-op diagnosis as covariates. Reported results in this analysis restricted to model based treatment effect estimate (laparotomy over drain) when pre-operative diagnosis is equal to NEC.||7.55|0.84|
72551183|NCT01029353|144632573|SUPERIORITY||Risk Ratio (RR)|1.05|||||TWO_SIDED|95.0|0.38|2.88|||||The model was fit using PROC GENMOD in SAS, using center as the repeated effect. Effect coding was used to represent the binary covariates.|This by treatment and by pre-operative diagnosis secondary analysis was completed by using a robust Poisson regression model, with log link and center as repeated measure. Model included treatment, baseline risk of death or NDI, pre-op diagnosis (NEC/IP), and treatment by pre-op diagnosis as covariates. Reported results in this analysis restricted to model based treatment effect estimate (laparotomy over drain) when pre-operative diagnosis is equal to IP.||2.88|0.38|
72583788|NCT03349060|144698386|SUPERIORITY||Difference in Percentage|4.2||||0.8647|TWO_SIDED|95.0|-36.3|44.7||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||44.7|-36.3|0.8647
72551184|NCT01029353|144632574|SUPERIORITY||Risk Ratio (RR)|1.78|||||TWO_SIDED|95.0|0.82|3.86|||||The model was fit using PROC GENMOD in SAS, using center as the repeated effect. Effect coding was used to represent the binary covariates.|This by treatment and by pre-operative diagnosis secondary analysis was completed by using a robust Poisson regression model, with log link and center as repeated measure. Model included treatment, baseline risk of death or NDI, pre-op diagnosis (NEC/IP), and treatment by pre-op diagnosis as covariates. Reported results in this analysis restricted to model based treatment effect estimate (laparotomy over drain) when pre-operative diagnosis is equal to NEC.||3.86|0.82|
72551185|NCT01029353|144632574|SUPERIORITY||Risk Ratio (RR)|1.16|||||TWO_SIDED|95.0|0.42|3.2|||||The model was fit using PROC GENMOD in SAS, using center as the repeated effect. Effect coding was used to represent the binary covariates.|This by treatment and by pre-operative diagnosis secondary analysis was completed by using a robust Poisson regression model, with log link and center as repeated measure. Model included treatment, baseline risk of death or NDI, pre-op diagnosis (NEC/IP), and treatment by pre-op diagnosis as covariates. Reported results in this analysis restricted to model based treatment effect estimate (laparotomy over drain) when pre-operative diagnosis is equal to IP.||3.20|0.42|
72551186|NCT01029353|144632575|SUPERIORITY||Risk Ratio (RR)|1.68|||||TWO_SIDED|95.0|0.35|8.05|||||The model was fit using PROC GENMOD in SAS, using center as the repeated effect. Effect coding was used to represent the binary covariates.|This by treatment and by pre-operative diagnosis secondary analysis was completed by using a robust Poisson regression model, with log link and center as repeated measure. Model included treatment, baseline risk of death or NDI, pre-op diagnosis (NEC/IP), and treatment by pre-op diagnosis as covariates. Reported results in this analysis restricted to model based treatment effect estimate (laparotomy over drain) when pre-operative diagnosis is equal to NEC.||8.05|0.35|
72551187|NCT01029353|144632575|SUPERIORITY||Risk Ratio (RR)|0.5|||||TWO_SIDED|95.0|0.1|2.44|||||The model was fit using PROC GENMOD in SAS, using center as the repeated effect. Effect coding was used to represent the binary covariates.|This by treatment and by pre-operative diagnosis secondary analysis was completed by using a robust Poisson regression model, with log link and center as repeated measure. Model included treatment, baseline risk of death or NDI, pre-op diagnosis (NEC/IP), and treatment by pre-op diagnosis as covariates. Reported results in this analysis restricted to model based treatment effect estimate (laparotomy over drain) when pre-operative diagnosis is equal to IP.||2.44|0.10|
72551188|NCT01029353|144632576|SUPERIORITY||Risk Ratio (RR)|1.29|||||TWO_SIDED|95.0|0.62|2.69|||||The model was fit using PROC GENMOD in SAS, using center as the repeated effect. Effect coding was used to represent the binary covariates.|This by treatment and by pre-operative diagnosis secondary analysis was completed by using a robust Poisson regression model, with log link and center as repeated measure. Model included treatment, baseline risk of death or NDI, pre-op diagnosis (NEC/IP), and treatment by pre-op diagnosis as covariates. Reported results in this analysis restricted to model based treatment effect estimate (laparotomy over drain) when pre-operative diagnosis is equal to NEC.||2.69|0.62|
72551189|NCT01029353|144632576|SUPERIORITY||Risk Ratio (RR)|0.6|||||TWO_SIDED|95.0|0.27|1.32|||||The model was fit using PROC GENMOD in SAS, using center as the repeated effect. Effect coding was used to represent the binary covariates.|This by treatment and by pre-operative diagnosis secondary analysis was completed by using a robust Poisson regression model, with log link and center as repeated measure. Model included treatment, baseline risk of death or NDI, pre-op diagnosis (NEC/IP), and treatment by pre-op diagnosis as covariates. Reported results in this analysis restricted to model based treatment effect estimate (laparotomy over drain) when pre-operative diagnosis is equal to IP.||1.32|0.27|
72551190|NCT01029353|144632577|SUPERIORITY||Risk Ratio (RR)|0.75|||||TWO_SIDED|95.0|0.41|1.36|||||The model was fit using PROC GENMOD in SAS, using center as the repeated effect. Effect coding was used to represent the binary covariates.|This by treatment and by pre-operative diagnosis secondary analysis was completed by using a robust Poisson regression model, with log link and center as repeated measure. Model included treatment, baseline risk of death or NDI, pre-op diagnosis (NEC/IP), and treatment by pre-op diagnosis as covariates. Reported results in this analysis restricted to model based treatment effect estimate (laparotomy over drain) when pre-operative diagnosis is equal to NEC.||1.36|0.41|
72552897|NCT00830206|144636833|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|An analysis of variance (ANOVA) was performed on the pharmacokimetic parameters using SAS® software.|Geometric Test/Ref Ratio x 100|101.92||||||90.0|95.18|109.14|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||109.14|95.18|
72552898|NCT04605094|144636834|OTHER||Difference in response rate|-8.62||||0.08|TWO_SIDED|95.0|-17.94|0.71|||Regression, Logistic|||"Treatment difference in IGA responders~Estimates were from a logistic regression model that included treatment group, age as recorded on electronic case report form (eCRF) at screening (\>=12 to \<18 years; \>=18 years), blood eosinophils as recorded on eCRF at screening (\<300 cells/microliters \[μL\]; \>=300 cells/μL) and baseline value of IGA score."||0.71|-17.94|0.080
72552899|NCT04605094|144636835|OTHER||Difference in response rate|-5.15||||0.384|TWO_SIDED|95.0|-16.67|6.36|||Regression, Logistic|||"Treatment difference in EASI-75 responders~Estimates were from a logistic regression model that included treatment group, age as recorded on eCRF at screening (\>=12 to \< 18 years; \>=18 years), blood eosinophils as recorded on eCRF at screening (\<300 cells/μL; \>=300 cells/μL) and baseline EASI total score."||6.36|-16.67|0.384
72552900|NCT04605094|144636836|OTHER||Difference in response rate|-8.18||||0.078|TWO_SIDED|95.0|-16.94|0.59|||Regression, Logistic|||"Treatment difference in EASI-90 responders~Estimates were from a logistic regression model that included treatment group, age as recorded on eCRF at screening (\>=12 to \< 18 years; \>=18 years), blood eosinophils as recorded on eCRF at screening (\<300 cells/μL; \>=300 cells/μL) and baseline EASI total score."||0.59|-16.94|0.078
72552901|NCT04605094|144636837|OTHER||Difference in response rate|0.69||||0.889|TWO_SIDED|95.0|-8.93|10.32|||Regression, Logistic|||"Treatment difference in Peak Pruritus NRS~Estimates were from a logistic regression model that included treatment group, age as recorded on eCRF at screening (\>=12 to \< 18 years; \>=18 years), blood eosinophils as recorded on eCRF at screening (\<300 cells/μL; \>=300 cells/μL) and baseline Peak Pruritus score."||10.32|-8.93|0.889
72552902|NCT02724462|144636838|SUPERIORITY||Odds Ratio (OR)|1.49|||<|0.001|TWO_SIDED|95.0|1.22|1.83|||Regression, Logistic|||||1.83|1.22|<.001
72552903|NCT02724462|144636839|SUPERIORITY||Odds Ratio (OR)|1.4||||0.001|TWO_SIDED|95.0|1.14|1.71|||Regression, Logistic|||||1.71|1.14|.001
72583789|NCT03349060|144698387|SUPERIORITY||Difference in Percentage|-78.6||||0.0546|TWO_SIDED|95.0|-117.5|-39.6||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||-39.6|-117.5|0.0546
72583790|NCT03349060|144698387|SUPERIORITY||Difference in Percentage|-27.9||||0.3573|TWO_SIDED|95.0|-62.5|6.7||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||6.7|-62.5|0.3573
72583791|NCT03349060|144698387|SUPERIORITY||Difference in Percentage|-3.6||||0.9219|TWO_SIDED|95.0|-55.6|48.5||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||48.5|-55.6|0.9219
72583792|NCT03349060|144698387|SUPERIORITY||Difference in Percentage|24.6||||0.3173|TWO_SIDED|95.0|-14.4|63.6||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||63.6|-14.4|0.3173
72583793|NCT03349060|144698387|SUPERIORITY||Difference in Percentage|-25.0||||0.5408|TWO_SIDED|95.0|-77.0|27.0||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||27.0|-77.0|0.5408
72583794|NCT03349060|144698387|SUPERIORITY||Difference in Percentage|24.6||||0.3173|TWO_SIDED|95.0|-14.4|63.6||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||63.6|-14.4|0.3173
72583795|NCT03349060|144698387|SUPERIORITY||Difference in Percentage|-25.0||||0.5408|TWO_SIDED|95.0|-77.0|27.0||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||27.0|-77.0|0.5408
72583796|NCT03349060|144698387|SUPERIORITY||Difference in Percentage|24.6||||0.3173|TWO_SIDED|95.0|-14.4|63.6||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||63.6|-14.4|0.3173
72583797|NCT03349060|144698388|SUPERIORITY||Difference in LS mean|-2.8||||0.0006|TWO_SIDED|95.0|-4.4|-1.2|||Mixed Models Analysis|||Change at Week 2: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-1.2|-4.4|0.0006
72583798|NCT03349060|144698388|SUPERIORITY||Difference in LS mean|-6.3|||<|0.0001|TWO_SIDED|95.0|-7.9|-4.7|||Mixed Models Analysis|||Change at Week 2: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-4.7|-7.9|<0.0001
72583799|NCT03349060|144698388|SUPERIORITY||Difference in LS mean|-3.8|||<|0.0001|TWO_SIDED|95.0|-5.6|-2.0|||Mixed Models Analysis|||Change at Week 4: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-2.0|-5.6|<0.0001
72583800|NCT03349060|144698388|SUPERIORITY||Difference in LS mean|-8.4|||<|0.0001|TWO_SIDED|95.0|-10.2|-6.6|||Mixed Models Analysis|||Change at Week 4: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-6.6|-10.2|<0.0001
72583801|NCT03349060|144698388|SUPERIORITY||Difference in LS mean|-2.7||||0.0096|TWO_SIDED|95.0|-4.7|-0.7|||Mixed Models Analysis|||Change at Week 8: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-0.7|-4.7|0.0096
72583802|NCT03349060|144698388|SUPERIORITY||Difference in LS mean|-7.2|||<|0.0001|TWO_SIDED|95.0|-9.3|-5.2|||Mixed Models Analysis|||Change at Week 8: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-5.2|-9.3|<0.0001
72583803|NCT03349060|144698388|SUPERIORITY||Difference in LS mean|-3.1||||0.0049|TWO_SIDED|95.0|-5.2|-0.9|||Mixed Models Analysis|||Change at Week 12: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-0.9|-5.2|0.0049
72551191|NCT01029353|144632577|SUPERIORITY||Risk Ratio (RR)|0.99|||||TWO_SIDED|95.0|0.69|1.42|||||The model was fit using PROC GENMOD in SAS, using center as the repeated effect. Effect coding was used to represent the binary covariates.|This by treatment and by pre-operative diagnosis secondary analysis was completed by using a robust Poisson regression model, with log link and center as repeated measure. Model included treatment, baseline risk of death or NDI, pre-op diagnosis (NEC/IP), and treatment by pre-op diagnosis as covariates. Reported results in this analysis restricted to model based treatment effect estimate (laparotomy over drain) when pre-operative diagnosis is equal to IP.||1.42|0.69|
72551192|NCT01029353|144632578|SUPERIORITY||Risk Ratio (RR)|0.43|||||TWO_SIDED|95.0|0.04|4.45|||||The model was fit using PROC GENMOD in SAS, using center as the repeated effect. Effect coding was used to represent the binary covariates.|This by treatment and by pre-operative diagnosis secondary analysis was completed by using a robust Poisson regression model, with log link and center as repeated measure. Model included treatment, baseline risk of death or NDI, pre-op diagnosis (NEC/IP), and treatment by pre-op diagnosis as covariates. Reported results in this analysis restricted to model based treatment effect estimate (laparotomy over drain) when pre-operative diagnosis is equal to NEC.||4.45|0.04|
72552904|NCT01969747|144636870|SUPERIORITY_OR_OTHER||Adjusted mean|76.09|STANDARD_ERROR_OF_MEAN|8.77|<|0.0001|TWO_SIDED|95.0|58.6|93.59|||ANCOVA||The model includes baseline UGE as linear covariate(s) and treatment as fixed effect(s).|Comparison of Empagliflozin 2.5 mg with Placebo||93.59|58.60|<0.0001
72552905|NCT01969747|144636870|SUPERIORITY_OR_OTHER||Adjusted mean|106.39|STANDARD_ERROR_OF_MEAN|8.85|<|0.0001|TWO_SIDED|95.0|88.73|124.05|||ANCOVA||The model includes baseline UGE as linear covariate(s) and treatment as fixed effect(s).|Comparison of Empagliflozin 10 mg with Placebo||124.05|88.73|<0.0001
72552906|NCT01969747|144636870|SUPERIORITY_OR_OTHER||Adjusted mean|104.81|STANDARD_ERROR_OF_MEAN|8.99|<|0.0001|TWO_SIDED|95.0|86.88|122.74|||ANCOVA||The model includes baseline UGE as linear covariate(s) and treatment as fixed effect(s).|Comparison of Empagliflozin 25 mg with Placebo||122.74|86.88|<0.0001
72552907|NCT02393417|144636871|SUPERIORITY||Risk Ratio (RR)|1.5706||||0.0329|TWO_SIDED|95.0|1.0184|2.4223|||Cochran-Mantel-Haenszel|||||2.4223|1.0184|0.0329
72552908|NCT02393417|144636871|SUPERIORITY||Risk Ratio (RR)|1.8926||||0.0007|TWO_SIDED|95.0|1.2722|2.8156|||Cochran-Mantel-Haenszel|||||2.8156|1.2722|0.0007
72552909|NCT02393417|144636871|SUPERIORITY||Risk Ratio (RR)|1.7319||||0.0052|TWO_SIDED|95.0|1.1602|2.5854|||Cochran-Mantel-Haenszel|||||2.5854|1.1602|0.0052
72552910|NCT02393417|144636872|SUPERIORITY||Risk Ratio (RR)|1.3828||||0.4307|TWO_SIDED|95.0|0.6191|3.0883|||Cochran-Mantel-Haenszel|||||3.0883|0.6191|0.4307
72552911|NCT02393417|144636872|SUPERIORITY||Risk Ratio (RR)|2.8908||||0.0014|TWO_SIDED|95.0|1.4169|5.8978|||Cochran-Mantel-Haenszel|||||5.8978|1.4169|0.0014
72552912|NCT02393417|144636872|SUPERIORITY||Risk Ratio (RR)|3.0||||0.0451|TWO_SIDED|95.0|0.9281|9.6975|||Cochran-Mantel-Haenszel|||||9.6975|0.9281|0.0451
72552913|NCT02393417|144636874|SUPERIORITY||Cox Proportional Hazard|2.7553||||0.0027|TWO_SIDED|95.0|1.4211|5.3419|||Regression, Cox|||||5.3419|1.4211|0.0027
72552914|NCT02393417|144636874|SUPERIORITY||Cox Proportional Hazard|3.1516||||0.0008|TWO_SIDED|95.0|1.6148|6.1509|||Regression, Cox|||||6.1509|1.6148|0.0008
72552915|NCT02393417|144636874|SUPERIORITY||Cox Proportional Hazard|3.3257||||0.0003|TWO_SIDED|95.0|1.7263|6.407|||Regression, Cox|||||6.4070|1.7263|0.0003
72552916|NCT02393417|144636880|SUPERIORITY||Odds Ratio (OR)|0.999||||0.4824|TWO_SIDED|95.0|0.997|1.001|||Regression, Logistic||An odds ratio \< 1 indicates that the age of the wart is negatively correlated with positive treatment outcome and vice versa.|Using a logistic regression model for complete resolution status of largest primary injected wart (yes vs no) with wart age as a covariate.||1.001|0.997|0.4824
72552917|NCT02393417|144636880|SUPERIORITY||Odds Ratio (OR)|1.001||||0.5007|TWO_SIDED|95.0|0.998|1.004|||Regression, Logistic||An odds ratio \< 1 indicates that the age of the wart is negatively correlated with positive treatment outcome and vice versa.|Using a logistic regression model for complete resolution status of largest primary injected wart (yes vs no) with wart age as a covariate.||1.004|0.998|0.5007
72552918|NCT02393417|144636880|SUPERIORITY||Odds Ratio (OR)|0.993||||0.0219|TWO_SIDED|95.0|0.987|0.999|||Regression, Logistic||An odds ratio \< 1 indicates that the age of the wart is negatively correlated with positive treatment outcome and vice versa.|Using a logistic regression model for complete resolution status of largest primary injected wart (yes vs no) with wart age as a covariate.||0.999|0.987|0.0219
72552919|NCT02393417|144636880|SUPERIORITY||Odds Ratio (OR)|1.0||||0.8267|TWO_SIDED|95.0|0.995|1.004|||Regression, Logistic||An odds ratio \< 1 indicates that the age of the wart is negatively correlated with positive treatment outcome and vice versa.|Using a logistic regression model for complete resolution status of largest primary injected wart (yes vs no) with wart age as a covariate.||1.004|0.995|0.8267
72552920|NCT02393417|144636881|SUPERIORITY||Odds Ratio (OR)|0.964||||0.1657|TWO_SIDED|95.0|0.915|1.015|||Regression, Logistic||An odds ratio \> 1 indicates that the age of the largest primary injected wart is positively correlated with the recurrence of any resolved wart and vice versa.|Using a logistic regression model for recurrence status of any resolved wart (yes vs no) with age of the largest primary injected wart as a covariate.||1.015|0.915|0.1657
72552921|NCT02393417|144636881|SUPERIORITY||Odds Ratio (OR)|1.0||||0.8168|TWO_SIDED|95.0|0.997|1.003|||Regression, Logistic||An odds ratio \> 1 indicates that the age of the largest primary injected wart is positively correlated with the recurrence of any resolved wart and vice versa.|Using a logistic regression model for recurrence status of any resolved wart (yes vs no) with age of the largest primary injected wart as a covariate.||1.003|0.997|0.8168
72551193|NCT01029353|144632578|SUPERIORITY||Risk Ratio (RR)|0.81|||||TWO_SIDED|95.0|0.44|1.49|||||The model was fit using PROC GENMOD in SAS, using center as the repeated effect. Effect coding was used to represent the binary covariates.|This by treatment and by pre-operative diagnosis secondary analysis was completed by using a robust Poisson regression model, with log link and center as repeated measure. Model included treatment, baseline risk of death or NDI, pre-op diagnosis (NEC/IP), and treatment by pre-op diagnosis as covariates. Reported results in this analysis restricted to model based treatment effect estimate (laparotomy over drain) when pre-operative diagnosis is equal to IP.||1.49|0.44|
72552922|NCT02393417|144636881|SUPERIORITY||Odds Ratio (OR)|0.998||||0.4183|TWO_SIDED|95.0|0.993|1.003|||Regression, Logistic||An odds ratio \> 1 indicates that the age of the largest primary injected wart is positively correlated with the recurrence of any resolved wart and vice versa.|Using a logistic regression model for recurrence status of any resolved wart (yes vs no) with age of the largest primary injected wart as a covariate.||1.003|0.993|0.4183
72552923|NCT02393417|144636881|SUPERIORITY||Odds Ratio (OR)|1.001||||0.5572|TWO_SIDED|95.0|0.997|1.006|||Regression, Logistic||An odds ratio \> 1 indicates that the age of the largest primary injected wart is positively correlated with the recurrence of any resolved wart and vice versa.|Using a logistic regression model for recurrence status of any resolved wart (yes vs no) with age of the largest primary injected wart as a covariate.||1.006|0.997|0.5572
72552924|NCT00829673|144636919|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model containing factors for sequence of products, subjects within sequence, periods, and products was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|107.82||||||90.0|100.24|115.98|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||115.98|100.24|
72552925|NCT00829673|144636920|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model containing factors for sequence of products, subjects within sequence, periods, and products was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|100.74||||||90.0|97.3|104.29|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||104.29|97.3|
72552926|NCT00829673|144636921|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model containing factors for sequence of products, subjects within sequence, periods, and products was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|100.5||||||90.0|97.09|104.03|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||104.03|97.09|
72552927|NCT03450057|144636922|OTHER|The PFS function was estimated using the Kaplan-Meier product-limit method, a non-parametric statistic.|||||||||||||||||The PFS function was estimated using the Kaplan-Meier product-limit method. Median and two-sided confidence intervals (CIs) for PFS were computed and Kaplan-Meier plots of PFS were developed.|||
72552928|NCT03450057|144636923|OTHER|The PFS function was estimated using the Kaplan-Meier product-limit method, a non-parametric statistic.|||||||||||||||||The PFS function was estimated using the Kaplan-Meier product-limit method. Median and two-sided confidence intervals (CIs) for PFS were computed and Kaplan-Meier plots of PFS were developed.|||
72552929|NCT03450057|144636924|OTHER|The PFS function was estimated using the Kaplan-Meier product-limit method, a non-parametric statistic.|||||||||||||||||The PFS function was estimated using the Kaplan-Meier product-limit method. Median and two-sided confidence intervals (CIs) for PFS were computed and Kaplan-Meier plots of PFS were developed.|||
72552930|NCT03450057|144636925|OTHER|The PFS function was estimated using the Kaplan-Meier product-limit method, a non-parametric statistic.|||||||||||||||||The PFS function was estimated using the Kaplan-Meier product-limit method. Median and one-sided confidence intervals (CIs) for PFS were computed and Kaplan-Meier plots of PFS were developed.|||
72552931|NCT03450057|144636926|OTHER|The PFS function was estimated using the Kaplan-Meier product-limit method, a non-parametric statistic.|||||||||||||||||The PFS function was estimated using the Kaplan-Meier product-limit method. Median and one-sided confidence intervals (CIs) for PFS were computed and Kaplan-Meier plots of PFS were developed.|||
72552932|NCT03450057|144636927|OTHER|The PFS function was estimated using the Kaplan-Meier product-limit method, a non-parametric statistic.|||||||||||||||||The PFS function was estimated using the Kaplan-Meier product-limit method. Median and one-sided confidence intervals (CIs) for PFS were computed and Kaplan-Meier plots of PFS were developed.|||
72552933|NCT00829790|144636938|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|114.49||||||90.0|109.25|119.98|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||119.98|109.25|
72413126|NCT00377676|144334899|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.58|||<|0.05|TWO_SIDED|95.0|0.35|0.96|||Regression, Cox|||In order to test the hypothesis for serious cardiovascular adverse events as for the primary endpoint at a one-sided alpha = 0.5 when the non-inferiority margin is 1.5, the final sample size of 3000 to 3300 subjects was to provide at least 62% power, assuming a hypothetical rate of events of 3.43%, or 103 to 113 cardiovascular SAEs. Upon demonstration of non-inferiority - a 2 sided using 95% CI was used to assess for superiority.||.96|.35|<0.05
72583804|NCT03349060|144698388|SUPERIORITY||Difference in LS mean|-6.9|||<|0.0001|TWO_SIDED|95.0|-9.0|-4.7|||Mixed Models Analysis|||Change at Week 12: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-4.7|-9.0|<0.0001
72583805|NCT03349060|144698389|SUPERIORITY||Difference in LS mean|-0.4||||0.002|TWO_SIDED|95.0|-0.6|-0.1|||Mixed Models Analysis|||Change at Week 2: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-0.1|-0.6|0.0020
72583806|NCT03349060|144698389|SUPERIORITY||Difference in LS mean|-0.8|||<|0.0001|TWO_SIDED|95.0|-1.0|-0.6|||Mixed Models Analysis|||Change at Week 2: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-0.6|-1.0|<0.0001
72583807|NCT03349060|144698389|SUPERIORITY||Difference in LS mean|-0.5||||0.0011|TWO_SIDED|95.0|-0.7|-0.2|||Mixed Models Analysis|||Change at Week 4: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-0.2|-0.7|0.0011
72583808|NCT03349060|144698389|SUPERIORITY||Difference in LS mean|-1.0|||<|0.0001|TWO_SIDED|95.0|-1.2|-0.7|||Mixed Models Analysis|||Change at Week 4: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-0.7|-1.2|<0.0001
72583809|NCT03349060|144698389|SUPERIORITY||Difference in LS mean|-0.5||||0.002|TWO_SIDED|95.0|-0.8|-0.2|||Mixed Models Analysis|||Change at Week 8: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-0.2|-0.8|0.0020
72583810|NCT03349060|144698389|SUPERIORITY||Difference in LS mean|-0.9|||<|0.0001|TWO_SIDED|95.0|-1.2|-0.6|||Mixed Models Analysis|||Change at Week 8: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-0.6|-1.2|<0.0001
72583811|NCT03349060|144698389|SUPERIORITY||Difference in LS mean|-0.5||||0.0014|TWO_SIDED|95.0|-0.8|-0.2|||Mixed Models Analysis|||Change at Week 12: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-0.2|-0.8|0.0014
72583812|NCT03349060|144698389|SUPERIORITY||Difference in LS mean|-0.9|||<|0.0001|TWO_SIDED|95.0|-1.3|-0.6|||Mixed Models Analysis|||Change at Week 12: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-0.6|-1.3|<0.0001
72551194|NCT01029353|144632579|SUPERIORITY||Mean Difference (Final Values)|-1.27|||||TWO_SIDED|95.0|-14.1|11.6|||||The model was fit using PROC MIXED in SAS, using center as the random effect. Effect coding was used to represent the binary covariates.|This by treatment and by pre-operative diagnosis secondary analysis was completed by using a mixed linear regression model, using center as the random effect. Model included treatment, baseline risk of death or NDI, pre-op diagnosis (NEC/IP), and treatment by pre-op diagnosis as covariates. Reported results in this analysis restricted to model based treatment effect estimate (laparotomy minus drain) when pre-operative diagnosis is equal to NEC.||11.60|-14.10|
72551195|NCT01029353|144632579|SUPERIORITY||Mean Difference (Final Values)|-7.85|||||TWO_SIDED|95.0|-15.84|0.13|||||The model was fit using PROC MIXED in SAS, using center as the random effect. Effect coding was used to represent the binary covariates.|This by treatment and by pre-operative diagnosis secondary analysis was completed by using a mixed linear regression model, using center as the random effect. Model included treatment, baseline risk of death or NDI, pre-op diagnosis (NEC/IP), and treatment by pre-op diagnosis as covariates. Reported results in this analysis restricted to model based treatment effect estimate (laparotomy minus drain) when pre-operative diagnosis is equal to IP.||0.13|-15.84|
72551196|NCT01029353|144632580|SUPERIORITY||Mean Difference (Final Values)|-11.57|||||TWO_SIDED|95.0|-27.15|4.01|||||The model was fit using PROC MIXED in SAS, using center as the random effect. Effect coding was used to represent the binary covariates.|This by treatment and by pre-operative diagnosis secondary analysis was completed by using a mixed linear regression model, using center as the random effect. Model included treatment, baseline risk of death or NDI, pre-op diagnosis (NEC/IP), and treatment by pre-op diagnosis as covariates. Reported results in this analysis restricted to model based treatment effect estimate (laparotomy minus drain) when pre-operative diagnosis is equal to NEC.||4.01|-27.15|
72583813|NCT03349060|144698390|SUPERIORITY||Difference in Percentage|6.0||||0.0575|TWO_SIDED|95.0|0.3|11.7||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||11.7|0.3|0.0575
72583814|NCT03349060|144698390|SUPERIORITY||Difference in Percentage|18.1||||0.0002|TWO_SIDED|95.0|10.7|25.5||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||25.5|10.7|0.0002
72583815|NCT03349060|144698390|SUPERIORITY||Difference in Percentage|9.2||||0.0411|TWO_SIDED|95.0|1.3|17.1||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||17.1|1.3|0.0411
72583816|NCT03349060|144698390|SUPERIORITY||Difference in Percentage|26.2|||<|0.0001|TWO_SIDED|95.0|16.9|35.5||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||35.5|16.9|<0.0001
72583817|NCT03349060|144698390|SUPERIORITY||Difference in Percentage|8.9||||0.0781|TWO_SIDED|95.0|-0.1|18.0||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||18.0|-0.1|0.0781
72583818|NCT03349060|144698390|SUPERIORITY||Difference in Percentage|26.2|||<|0.0001|TWO_SIDED|95.0|16.2|36.3||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||36.3|16.2|<0.0001
72583819|NCT03349060|144698390|SUPERIORITY||Difference in Percentage|14.2||||0.0075|TWO_SIDED|95.0|5.3|23.2||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||23.2|5.3|0.0075
72583820|NCT03349060|144698390|SUPERIORITY||Difference in Percentage|29.3|||<|0.0001|TWO_SIDED|95.0|19.6|38.9||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||38.9|19.6|<0.0001
72583821|NCT03349060|144698391|SUPERIORITY||Difference in LS mean|0.034||||0.0453|TWO_SIDED|95.0|0.001|0.066|||Mixed Models Analysis|||Change at Week 2: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||0.066|0.001|0.0453
72583822|NCT03349060|144698391|SUPERIORITY||Difference in LS mean|0.068|||<|0.0001|TWO_SIDED|95.0|0.036|0.101|||Mixed Models Analysis|||Change at Week 2: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||0.101|0.036|<0.0001
72583823|NCT03349060|144698391|SUPERIORITY||Difference in LS mean|0.025||||0.1821|TWO_SIDED|95.0|-0.012|0.062|||Mixed Models Analysis|||Change at Week 4: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||0.062|-0.012|0.1821
72583824|NCT03349060|144698391|SUPERIORITY||Difference in LS mean|0.055||||0.0038|TWO_SIDED|95.0|0.018|0.092|||Mixed Models Analysis|||Change at Week 4: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||0.092|0.018|0.0038
72583825|NCT03349060|144698391|SUPERIORITY||Difference in LS mean|0.048||||0.0241|TWO_SIDED|95.0|0.006|0.09|||Mixed Models Analysis|||Change at Week 8: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||0.090|0.006|0.0241
72583826|NCT03349060|144698391|SUPERIORITY||Difference in LS mean|0.093|||<|0.0001|TWO_SIDED|95.0|0.051|0.134|||Mixed Models Analysis|||Change at Week 8: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||0.134|0.051|<0.0001
72583827|NCT03349060|144698391|SUPERIORITY||Difference in LS mean|0.044||||0.0461|TWO_SIDED|95.0|0.001|0.087|||Mixed Models Analysis|||Change at Week 12: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||0.087|0.001|0.0461
72583828|NCT03349060|144698391|SUPERIORITY||Difference in LS mean|0.064||||0.0037|TWO_SIDED|95.0|0.021|0.107|||Mixed Models Analysis|||Change at Week 12: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||0.107|0.021|0.0037
72583829|NCT03349060|144698392|SUPERIORITY||Difference in LS mean|4.548||||0.0319|TWO_SIDED|95.0|0.397|8.7|||Mixed Models Analysis|||Change at Week 2: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||8.700|0.397|0.0319
72583830|NCT03349060|144698392|SUPERIORITY||Difference in LS mean|8.659|||<|0.0001|TWO_SIDED|95.0|4.496|12.822|||Mixed Models Analysis|||Change at Week 2: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||12.822|4.496|<0.0001
72583831|NCT03349060|144698392|SUPERIORITY||Difference in LS mean|4.361||||0.0702|TWO_SIDED|95.0|-0.362|9.084|||Mixed Models Analysis|||Change at Week 4: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||9.084|-0.362|0.0702
72583832|NCT03349060|144698392|SUPERIORITY||Difference in LS mean|10.085|||<|0.0001|TWO_SIDED|95.0|5.349|14.821|||Mixed Models Analysis|||Change at Week 4: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||14.821|5.349|<0.0001
72583833|NCT03349060|144698392|SUPERIORITY||Difference in LS mean|6.045||||0.03|TWO_SIDED|95.0|0.589|11.501|||Mixed Models Analysis|||Change at Week 8: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||11.501|0.589|0.0300
72583834|NCT03349060|144698392|SUPERIORITY||Difference in LS mean|9.803||||0.0005|TWO_SIDED|95.0|4.368|15.237|||Mixed Models Analysis|||Change at Week 8: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||15.237|4.368|0.0005
72413127|NCT00377676|144334900|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5|STANDARD_DEVIATION|1.4|<|0.001|||||||ANOVA|||If the standard deviation of HbA1c level is about 1.0% and the baseline and 24 week scores have a correlation of 0.50 then the effect size is 0.5%/1.0% = 0.50. For the metformin/SU analysis, 160 subjects assuming a standard deviation of 1.0% would provide a power of 90% power to detect differences in mean changes of 0.5% or larger.||||<0.001
72413128|NCT00377676|144334901|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5|||<|0.001|||||||ANOVA|||||||<0.001
72413129|NCT03579459|144334904|EQUIVALENCE|Equivalence was established if the 95% confidence interval of GMC ratio was within the interval (0.5, 2).|Geometric Mean ratio (GMR)|1.01|||||TWO_SIDED|95.0|0.86|1.18|||||Confidence intervals (CIs) were back transformations of confidence levels based on the Student t distribution for the mean logarithm of the concentrations|Toxin A||1.18|0.86|
72413130|NCT03579459|144334904|EQUIVALENCE|Equivalence was established if the 95% confidence interval of GMC ratio was within the interval (0.5, 2).|GMR|1.01|||||TWO_SIDED|95.0|0.86|1.18|||||CIs were back transformations of confidence levels based on the Student t distribution for the mean logarithm of the concentrations|Toxin A||1.18|0.86|
72413131|NCT03579459|144334904|EQUIVALENCE|Equivalence was established if the 95% confidence interval of GMC ratio was within the interval (0.5, 2).|GMR|1.0|||||TWO_SIDED|95.0|0.85|1.17|||||CIs were back transformations of confidence levels based on the Student t distribution for the mean logarithm of the concentrations|Toxin A||1.17|0.85|
72413132|NCT03579459|144334904|EQUIVALENCE|Equivalence was established if the 95% confidence interval of GMC ratio was within the interval (0.5, 2).|GMR|1.07|||||TWO_SIDED|95.0|0.87|1.31|||||CIs were back transformations of confidence levels based on the Student t distribution for the mean logarithm of the concentrations|Toxin B||1.31|0.87|
72551197|NCT01029353|144632580|SUPERIORITY||Mean Difference (Final Values)|-7.63|||||TWO_SIDED|95.0|-17.46|2.2|||||The model was fit using PROC MIXED in SAS, using center as the random effect. Effect coding was used to represent the binary covariates.|This by treatment and by pre-operative diagnosis secondary analysis was completed by using a mixed linear regression model, using center as the random effect. Model included treatment, baseline risk of death or NDI, pre-op diagnosis (NEC/IP), and treatment by pre-op diagnosis as covariates. Reported results in this analysis restricted to model based treatment effect estimate (laparotomy minus drain) when pre-operative diagnosis is equal to IP.||2.20|-17.46|
72551198|NCT01029353|144632581|SUPERIORITY||Mean Difference (Final Values)|4.0|||||TWO_SIDED|95.0|-18.84|26.83|||||The model was fit using PROC MIXED in SAS, using center as the random effect. Effect coding was used to represent the binary covariates.|This by treatment and by pre-operative diagnosis secondary analysis was completed by using a mixed linear regression model, using center as the random effect. Model included treatment, baseline risk of death or NDI, pre-op diagnosis (NEC/IP), and treatment by pre-op diagnosis as covariates. Reported results in this analysis restricted to model based treatment effect estimate (laparotomy minus drain) when pre-operative diagnosis is equal to NEC.||26.83|-18.84|
72551199|NCT01029353|144632581|SUPERIORITY||Mean Difference (Final Values)|9.05|||||TWO_SIDED|95.0|-13.29|31.38|||||The model was fit using PROC MIXED in SAS, using center as the random effect. Effect coding was used to represent the binary covariates.|This by treatment and by pre-operative diagnosis secondary analysis was completed by using a mixed linear regression model, using center as the random effect. Model included treatment, baseline risk of death or NDI, pre-op diagnosis (NEC/IP), and treatment by pre-op diagnosis as covariates. Reported results in this analysis restricted to model based treatment effect estimate (laparotomy minus drain) when pre-operative diagnosis is equal to IP.||31.38|-13.29|
72552934|NCT00829790|144636939|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|117.16||||||90.0|110.44|124.28|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||124.28|110.44|
72413133|NCT03579459|144334904|EQUIVALENCE|Equivalence was established if the 95% confidence interval of GMC ratio was within the interval (0.5, 2).|GMR|1.07|||||TWO_SIDED|95.0|0.88|1.31|||||CIs were back transformations of confidence levels based on the Student t distribution for the mean logarithm of the concentrations|Toxin B||1.31|0.88|
72552935|NCT00829790|144636940|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|116.7||||||90.0|109.89|123.92|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||123.92|109.89|
72413134|NCT03579459|144334904|EQUIVALENCE|Equivalence was established if the 95% confidence interval of GMC ratio was within the interval (0.5, 2).|GMR|1.01|||||TWO_SIDED|95.0|0.83|1.23|||||CIs were back transformations of confidence levels based on the Student t distribution for the mean logarithm of the concentrations|Toxin B||1.23|0.83|
72413135|NCT00148343|144334913|SUPERIORITY_OR_OTHER||Slope|1.26|STANDARD_ERROR_OF_MEAN|0.76|||TWO_SIDED|95.0|-0.2|2.75|||||Mixed model analysis. Slope is in reference to treatment x time interaction for full 36 weeks|||2.75|-0.2|
72413136|NCT00148343|144334914|SUPERIORITY||Slope|-5.07|STANDARD_ERROR_OF_MEAN|2.54|<|0.05|TWO_SIDED|95.0|-10.05|-0.09|||Mixed Models Analysis||Slope is in reference to from baseline to end of follow-up at 36 weeks.|||-0.09|-10.05|<0.05
72552936|NCT02246166|144636941|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.03||||0.9473|TWO_SIDED|95.0|-0.77|0.83|||ANCOVA|From ANCOVA model with factors for treatment group and study site and baseline TSS score as a covariate|Difference is first named treatment minus the second named treatment such that a negative difference favors the first named treatment|||0.83|-0.77|0.9473
72413137|NCT00148343|144334915|SUPERIORITY_OR_OTHER||Slope|0.31|STANDARD_ERROR_OF_MEAN|7.35|<|0.05|TWO_SIDED|95.0|-14.096|14.716|||Mixed Models Analysis||Slope is in reference to start of treatment to end of follow up at 36 weeks|||14.716|-14.096|<0.05
72413138|NCT00148343|144334916|SUPERIORITY||Slope|-1.95|STANDARD_ERROR_OF_MEAN|5.53|||TWO_SIDED|95.0|-12.79|8.89|||||Mixed models analysis. Slope refers to baseline to final follow up at 36 weeks|||8.89|-12.79|
72413139|NCT00148343|144334917|SUPERIORITY||Slope|0.006|STANDARD_ERROR_OF_MEAN|0.026|<|0.05|TWO_SIDED|95.0|-0.045|0.057|||Mixed Models Analysis||Slope is in reference to baseline to end of follow-up at 36 weeks|||0.057|-0.045|<0.05
72413140|NCT04153409|144334918|SUPERIORITY|No formal sample size estimation was undertaken due to the exploratory nature of the study. Statistical comparisons of the 7 mean changes from baseline to different time-points (0-24 hours) were undertaken in one mixed effects model of analysis taking into account the cross-over nature of the study and the multiple time points within each period to explore a possible treatment effect in this small proof of concept study. Change from baseline at 0.5 hours is presented in this section|Mean Difference (Net)|-0.02||||0.9733|TWO_SIDED|95.0|-1.23|1.19||No adjustment for multiple comparisons has been made due to the exploratory nature of the study|Mixed Models Analysis||Difference is Active-Placebo|Change from baseline at 0.5 hours||1.19|-1.23|0.9733
72551200|NCT01029353|144632582|SUPERIORITY||Mean Difference (Final Values)|-3.13|||||TWO_SIDED|95.0|-24.62|18.36|||||The model was fit using PROC MIXED in SAS, using center as the random effect. Effect coding was used to represent the binary covariates.|This by treatment and by pre-operative diagnosis secondary analysis was completed by using a mixed linear regression model, using center as the random effect. Model included treatment, baseline risk of death or NDI, pre-op diagnosis (NEC/IP), and treatment by pre-op diagnosis as covariates. Reported results in this analysis restricted to model based treatment effect estimate (laparotomy minus drain) when pre-operative diagnosis is equal to NEC.||18.36|-24.62|
72551201|NCT01029353|144632582|SUPERIORITY||Mean Difference (Final Values)|-2.39|||||TWO_SIDED|95.0|-14.42|9.63|||||The model was fit using PROC MIXED in SAS, using center as the random effect. Effect coding was used to represent the binary covariates. Reported results in this analysis restricted to infants with IP.|This by treatment and by pre-operative diagnosis secondary analysis was completed by using a mixed linear regression model, using center as the random effect. Model included treatment, baseline risk of death or NDI, pre-op diagnosis (NEC/IP), and treatment by pre-op diagnosis as covariates. Reported results in this analysis restricted to model based treatment effect estimate (laparotomy minus drain) when pre-operative diagnosis is equal to IP.||9.63|-14.42|
72551202|NCT01029353|144632583|SUPERIORITY||Mean Difference (Final Values)|-18.43|||||TWO_SIDED|95.0|-48.41|11.55|||||The model was fit using PROC MIXED in SAS, using center as the random effect. Effect coding was used to represent the binary covariates.|This by treatment and by pre-operative diagnosis secondary analysis was completed by using a mixed linear regression model, using center as the random effect. Model included treatment, baseline risk of death or NDI, pre-op diagnosis (NEC/IP), and treatment by pre-op diagnosis as covariates. Reported results in this analysis restricted to model based treatment effect estimate (laparotomy minus drain) when pre-operative diagnosis is equal to NEC.||11.55|-48.41|
72583835|NCT03349060|144698392|SUPERIORITY||Difference in LS mean|7.569||||0.0067|TWO_SIDED|95.0|2.119|13.019|||Mixed Models Analysis|||Change at Week 12: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||13.019|2.119|0.0067
72583836|NCT03349060|144698392|SUPERIORITY||Difference in LS mean|9.374||||0.0008|TWO_SIDED|95.0|3.933|14.815|||Mixed Models Analysis|||Change at Week 12: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||14.815|3.933|0.0008
72583837|NCT03349060|144698393|SUPERIORITY||Difference in LS mean|-0.004||||0.9568|TWO_SIDED|95.0|-0.137|0.13|||Mixed Models Analysis|||Change at Week 2: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||0.130|-0.137|0.9568
72583838|NCT03349060|144698393|SUPERIORITY||Difference in LS mean|0.09||||0.1782|TWO_SIDED|95.0|-0.042|0.223|||Mixed Models Analysis|||Change at Week 2: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||0.223|-0.042|0.1782
72583839|NCT03349060|144698393|SUPERIORITY||Difference in LS mean|0.174||||0.0491|TWO_SIDED|95.0|0.001|0.347|||Mixed Models Analysis|||Change at Week 4: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||0.347|0.001|0.0491
72583840|NCT03349060|144698393|SUPERIORITY||Difference in LS mean|0.284||||0.0015|TWO_SIDED|95.0|0.112|0.456|||Mixed Models Analysis|||Change at Week 4: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||0.456|0.112|0.0015
72583841|NCT03349060|144698393|SUPERIORITY||Difference in LS mean|0.004||||0.9638|TWO_SIDED|95.0|-0.185|0.194|||Mixed Models Analysis|||Change at Week 8: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||0.194|-0.185|0.9638
72583842|NCT03349060|144698393|SUPERIORITY||Difference in LS mean|0.08||||0.4016|TWO_SIDED|95.0|-0.109|0.27|||Mixed Models Analysis|||Change at Week 8: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||0.270|-0.109|0.4016
72583843|NCT03349060|144698393|SUPERIORITY||Difference in LS mean|0.007||||0.9429|TWO_SIDED|95.0|-0.184|0.198|||Mixed Models Analysis|||Change at Week 12: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||0.198|-0.184|0.9429
72583844|NCT03349060|144698393|SUPERIORITY||Difference in LS mean|0.062||||0.5212|TWO_SIDED|95.0|-0.13|0.254|||Mixed Models Analysis|||Change at Week 12: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||0.254|-0.130|0.5212
72583845|NCT03349060|144698394|SUPERIORITY||Difference in LS mean|2.131||||0.6467|TWO_SIDED|95.0|-7.095|11.358|||Mixed Models Analysis|||Change at Week 2: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||11.358|-7.095|0.6467
72583846|NCT03349060|144698394|SUPERIORITY||Difference in LS mean|11.549||||0.0147|TWO_SIDED|95.0|2.338|20.761|||Mixed Models Analysis|||Change at Week 2: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||20.761|2.338|0.0147
72413141|NCT04153409|144334918|SUPERIORITY||Mean Difference (Net)|-0.42||||0.4942|TWO_SIDED|95.0|-1.64|0.79||No adjustment for multiple comparisons has been made due to the exploratory nature of the study|Mixed Models Analysis||Difference is Active-Placebo|Change from baseline at 1 hour. The change from baseline at 1 hour was extracted from the mixed model analysis including all time points.||0.79|-1.64|0.4942
72551203|NCT01029353|144632583|SUPERIORITY||Mean Difference (Final Values)|-11.95|||||TWO_SIDED|95.0|-31.96|8.06|||||The model was fit using PROC MIXED in SAS, using center as the random effect. Effect coding was used to represent the binary covariates.|This by treatment and by pre-operative diagnosis secondary analysis was completed by using a mixed linear regression model, using center as the random effect. Model included treatment, baseline risk of death or NDI, pre-op diagnosis (NEC/IP), and treatment by pre-op diagnosis as covariates. Reported results in this analysis restricted to model based treatment effect estimate (laparotomy minus drain) when pre-operative diagnosis is equal to IP.||8.06|-31.96|
72551204|NCT03603314|144632586|SUPERIORITY|||||||0.3419|||||||Mixed Models Analysis|||The null and alternative hypotheses for Part 1 of the study were as follows, where μH, μL and μP were defined as the mean change in PTA of the high dose, low dose, and placebo respectively: H0H: μH - μP = 0, HAH: μH - μP \<0 (greater decrease on high dose) H0L: μL - μP = 0, HAL: μL - μP \<0 (greater decrease on low dose)||||0.3419
72583847|NCT03349060|144698394|SUPERIORITY||Difference in LS mean|6.853||||0.1894|TWO_SIDED|95.0|-3.453|17.159|||Mixed Models Analysis|||Change at Week 4: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||17.159|-3.453|0.1894
72583848|NCT03349060|144698394|SUPERIORITY||Difference in LS mean|16.99||||0.0015|TWO_SIDED|95.0|6.699|27.281|||Mixed Models Analysis|||Change at Week 4: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||27.281|6.699|0.0015
72583849|NCT03349060|144698394|SUPERIORITY||Difference in LS mean|8.672||||0.1267|TWO_SIDED|95.0|-2.518|19.862|||Mixed Models Analysis|||Change at Week 8: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||19.862|-2.518|0.1267
72583850|NCT03349060|144698394|SUPERIORITY||Difference in LS mean|9.354||||0.1009|TWO_SIDED|95.0|-1.866|20.573|||Mixed Models Analysis|||Change at Week 8: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||20.573|-1.866|0.1009
72583851|NCT03349060|144698394|SUPERIORITY||Difference in LS mean|6.071||||0.1915|TWO_SIDED|95.0|-3.107|15.249|||Mixed Models Analysis|||Change at Week 12: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||15.249|-3.107|0.1915
72583852|NCT03349060|144698394|SUPERIORITY||Difference in LS mean|12.948||||0.0064|TWO_SIDED|95.0|3.754|22.143|||Mixed Models Analysis|||Change at Week 12: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||22.143|3.754|0.0064
72413142|NCT04153409|144334918|SUPERIORITY||Mean Difference (Net)|-0.25||||0.6866|TWO_SIDED|95.0|-1.46|0.97||No adjustment for multiple comparisons has been made due to the exploratory nature of the study|Mixed Models Analysis||Difference is Active-Placebo|Change from baseline at 1.5 hours. The change from baseline at 1.5 hours was extracted from the mixed model analysis including all time points.||0.97|-1.46|0.6866
72551205|NCT03603314|144632586|SUPERIORITY|||||||0.5181|||||||Mixed Models Analysis|||The null and alternative hypotheses for Part 1 of the study were as follows, where μH, μL and μP were defined as the mean change in PTA of the high dose, low dose, and placebo respectively: H0H: μH - μP = 0, HAH: μH - μP \<0 (greater decrease on high dose) H0L: μL - μP = 0, HAL: μL - μP \<0 (greater decrease on low dose)||||0.5181
72551206|NCT03603314|144632587|SUPERIORITY|||||||0.3666|||||||Mixed Models Analysis|||The null and alternative hypotheses for Part 1 of the study were as follows, where μH, μL and μP were defined as the mean change in PTA of the high dose, low dose, and placebo respectively: H0H: μH - μP = 0, HAH: μH - μP \<0 (greater decrease on high dose) H0L: μL - μP = 0, HAL: μL - μP \<0 (greater decrease on low dose)||||0.3666
72551207|NCT03603314|144632587|SUPERIORITY|||||||0.5776|||||||Mixed Models Analysis|||The null and alternative hypotheses for Part 1 of the study were as follows, where μH, μL and μP were defined as the mean change in PTA of the high dose, low dose, and placebo respectively: H0H: μH - μP = 0, HAH: μH - μP \<0 (greater decrease on high dose) H0L: μL - μP = 0, HAL: μL - μP \<0 (greater decrease on low dose)||||0.5776
72551208|NCT03603314|144632588|SUPERIORITY|||||||0.4094|||||||Mixed Models Analysis|||The null and alternative hypotheses for Part 1 of the study were as follows, where μH, μL and μP were defined as the mean change in PTA of the high dose, low dose, and placebo respectively: H0H: μH - μP = 0, HAH: μH - μP \<0 (greater decrease on high dose) H0L: μL - μP = 0, HAL: μL - μP \<0 (greater decrease on low dose)||||0.4094
72551209|NCT03603314|144632588|SUPERIORITY|||||||0.4602|||||||Mixed Models Analysis|||The null and alternative hypotheses for Part 1 of the study were as follows, where μH, μL and μP were defined as the mean change in PTA of the high dose, low dose, and placebo respectively: H0H: μH - μP = 0, HAH: μH - μP \<0 (greater decrease on high dose) H0L: μL - μP = 0, HAL: μL - μP \<0 (greater decrease on low dose)||||0.4602
72551210|NCT03603314|144632589|SUPERIORITY|||||||0.1269|||||||Mixed Models Analysis|||The null and alternative hypotheses for Part 1 of the study were as follows, where μH, μL and μP were defined as the mean change in PTA of the high dose, low dose, and placebo respectively: H0H: μH - μP = 0, HAH: μH - μP \<0 (greater decrease on high dose) H0L: μL - μP = 0, HAL: μL - μP \<0 (greater decrease on low dose)||||0.1269
72551211|NCT03603314|144632589|SUPERIORITY|||||||0.2257|||||||Mixed Models Analysis|||The null and alternative hypotheses for Part 1 of the study were as follows, where μH, μL and μP were defined as the mean change in PTA of the high dose, low dose, and placebo respectively: H0H: μH - μP = 0, HAH: μH - μP \<0 (greater decrease on high dose) H0L: μL - μP = 0, HAL: μL - μP \<0 (greater decrease on low dose)||||0.2257
72551212|NCT03603314|144632590|SUPERIORITY|||||||0.3121|||||||Mixed Models Analysis|||The null and alternative hypotheses for Part 1 of the study were as follows, where μH, μL and μP were defined as the mean change in PTA of the high dose, low dose, and placebo respectively: H0H: μH - μP = 0, HAH: μH - μP \<0 (greater decrease on high dose) H0L: μL - μP = 0, HAL: μL - μP \<0 (greater decrease on low dose)||||0.3121
72551213|NCT03603314|144632590|SUPERIORITY|||||||0.4965|||||||Mixed Models Analysis|||The null and alternative hypotheses for Part 1 of the study were as follows, where μH, μL and μP were defined as the mean change in PTA of the high dose, low dose, and placebo respectively: H0H: μH - μP = 0, HAH: μH - μP \<0 (greater decrease on high dose) H0L: μL - μP = 0, HAL: μL - μP \<0 (greater decrease on low dose)||||0.4965
72551214|NCT03603314|144632591|SUPERIORITY|||||||0.0976|||||||Mixed Models Analysis|||The null and alternative hypotheses for Part 1 of the study were as follows, where μH, μL and μP were defined as the mean change in PTA of the high dose, low dose, and placebo respectively: H0H: μH - μP = 0, HAH: μH - μP \<0 (greater decrease on high dose) H0L: μL - μP = 0, HAL: μL - μP \<0 (greater decrease on low dose)||||0.0976
72551215|NCT03603314|144632591|SUPERIORITY|||||||0.1762|||||||Mixed Models Analysis|||The null and alternative hypotheses for Part 1 of the study were as follows, where μH, μL and μP were defined as the mean change in PTA of the high dose, low dose, and placebo respectively: H0H: μH - μP = 0, HAH: μH - μP \<0 (greater decrease on high dose) H0L: μL - μP = 0, HAL: μL - μP \<0 (greater decrease on low dose)||||0.1762
72551216|NCT04625114|144632637|SUPERIORITY||Mean Difference (Final Values)|1.183||||0.511|TWO_SIDED||||||Mixed Models Analysis|||||||0.511
72551217|NCT04625114|144632638|SUPERIORITY||Cox Proportional Hazard|0.965||||0.921|TWO_SIDED|95.0|0.48|1.942|||Regression, Cox|||||1.942|0.480|0.921
72369794|NCT04857320|144249950|SUPERIORITY|||||||3e-06|||||||t-test, 1 sided|||Subject received doses applied to the skin of 0.075, 0.10 and 0.15 IUs / Kilogram on successive days. The Subject's average Serum Glucose for these 3 days were compared against the Subject's baseline unmedicated Serum Glucose on non-dosed days.||||0.000003
72369795|NCT04857320|144249950|SUPERIORITY|||||||2e-06|||||||t-test, 1 sided|Degrees of Freedom = 3||||||0.000002
72369796|NCT04857320|144249950|SUPERIORITY|||||||3.5e-05|||||||t-test, 1 sided|Degrees of Freedom = 3||||||0.000035
72369797|NCT04857320|144249950|SUPERIORITY|||||||4e-06|||||||t-test, 1 sided|Degrees of Freedom = 3||||||0.000004
72369798|NCT04857320|144249951|SUPERIORITY|||||||0|||||||ANOVA|||||||0
72551218|NCT03221374|144632657|OTHER|Linear mixed effect model to test the overall BCI learning between MBSR and control groups||||||0.003||||||The threshold for statistical analysis was p = 0.05.|Mixed Models Analysis|||||||0.003
72551219|NCT03221374|144632657|EQUIVALENCE|This independent t-test will test if the two groups (MBSR, control) exhibit a statistically significant difference in terms of BCI performance from baseline.|Mean Difference (Net)|8.98||||0.024|TWO_SIDED|||||The threshold for statistical analysis was p = 0.05|t-test, 2 sided||The difference between BCI performance improvement in MBSR cohort and control cohort.|||||0.024
72551220|NCT03221374|144632658|EQUIVALENCE|This WRS test will determine if the MBSR group breath counting accuracy was significantly greater than the postintervention levels of controls.|Mean Difference (Net)|15.4|||<|0.001|TWO_SIDED|||||The threshold for statistical analysis was p = 0.05|Wilcoxon (Mann-Whitney)|||||||<0.001
72551221|NCT03221374|144632659|EQUIVALENCE|The null hypothesis is that the FMI scores of the two groups have equal medians.|Mean Difference (Final Values)|7.9|||<|0.01|TWO_SIDED|||||significant if p\<0.05|Wilcoxon (Mann-Whitney)|||||||<0.01
72551222|NCT03221374|144632659|EQUIVALENCE|The null hypothesis is that the MAAS scores of the two groups have equal medians.|Mean Difference (Final Values)|0.69|||<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<0.05
72551223|NCT03221374|144632659|OTHER|This statistical test is about the correlation between baseline up-down BCI performance and the FMI score. A linear regression model is used to test if the slope is non-zero.|correlation coefficient|0.42|||<|0.05|TWO_SIDED|||||significant if p\<0.05|Regression, Linear|||||||<0.05
72583853|NCT03349060|144698395|SUPERIORITY||Difference in LS mean|3.6||||0.0102|TWO_SIDED|95.0|0.9|6.4||Analysis of covariance (ANCOVA) model was used including treatment as main effect and randomization strata (baseline disease severity and age category) and baseline value as covariates.|ANCOVA|||||6.4|0.9|0.0102
72583854|NCT03349060|144698395|SUPERIORITY||Difference in LS mean|4.5||||0.0013|TWO_SIDED|95.0|1.8|7.3||ANCOVA model was used including treatment as main effect and randomization strata (baseline disease severity and age category) and baseline value as covariates.|ANCOVA|||||7.3|1.8|0.0013
72583855|NCT03349060|144698396|SUPERIORITY||Difference in LS mean|1.0||||0.5241|TWO_SIDED|95.0|-2.1|4.2||ANCOVA model was used including treatment as main effect and randomization strata (baseline disease severity and age category) and baseline value as covariates.|ANCOVA|||||4.2|-2.1|0.5241
72583856|NCT03349060|144698396|SUPERIORITY||Difference in LS mean|0.9||||0.5821|TWO_SIDED|95.0|-2.3|4.1||ANCOVA model was used including treatment as main effect and randomization strata (baseline disease severity and age category) and baseline value as covariates.|ANCOVA|||||4.1|-2.3|0.5821
72583857|NCT03349060|144698397|SUPERIORITY||Difference in LS mean|3.8||||0.0013|TWO_SIDED|95.0|1.5|6.1||ANCOVA model was used including treatment as main effect and randomization strata (baseline disease severity and age category) and baseline value as covariates.|ANCOVA|||||6.1|1.5|0.0013
72583858|NCT03349060|144698397|SUPERIORITY||Difference in LS mean|4.7|||<|0.0001|TWO_SIDED|95.0|2.4|7.0||ANCOVA model was used including treatment as main effect and randomization strata (baseline disease severity and age category) and baseline value as covariates.|ANCOVA|||||7.0|2.4|<0.0001
72583859|NCT03349060|144698398|SUPERIORITY||Difference in LS mean|1.7||||0.2256|TWO_SIDED|95.0|-1.0|4.4||ANCOVA model was used including treatment as main effect and randomization strata (baseline disease severity and age category) and baseline value as covariates.|ANCOVA|||||4.4|-1.0|0.2256
72583860|NCT03349060|144698398|SUPERIORITY||Difference in LS mean|3.0||||0.0275|TWO_SIDED|95.0|0.3|5.8||ANCOVA model was used including treatment as main effect and randomization strata (baseline disease severity and age category) and baseline value as covariates.|ANCOVA|||||5.8|0.3|0.0275
72583861|NCT02861586|144698400|SUPERIORITY||Geometric mean ratio|3.9|||<|0.0001|TWO_SIDED|95.0|2.0|7.7||Pairwise comparisons were adjusted for multiple tests according to Tukey-Kramer. The threshold for significance was 0.05.|ANOVA|Analysis of variance was conducted with treatment group as a fixed factor.||||7.7|2.0|<0.0001
72583862|NCT02861586|144698400|SUPERIORITY||Geometric mean ratio|0.3|||<|0.0001|TWO_SIDED|95.0|0.1|0.6||Pairwise comparisons were adjusted for multiple tests according to Tukey-Kramer. The threshold for significance was 0.05.|ANOVA|Analysis of variance was conducted with treatment group as a fixed factor.||||0.6|0.1|<0.0001
72583863|NCT02861586|144698400|SUPERIORITY||Geometric mean ratio|1.5||||0.6334|TWO_SIDED|95.0|0.8|3.0||Pairwise comparisons were adjusted for multiple tests according to Tukey-Kramer. The threshold for significance was 0.05.|ANOVA|Analysis of variance was conducted with treatment group as a fixed factor.||||3.0|0.8|0.6334
72583864|NCT02861586|144698400|SUPERIORITY||Geometric mean ratio|0.6||||0.8065|TWO_SIDED|95.0|0.2|1.6||Pairwise comparisons were adjusted for multiple tests according to Tukey-Kramer. The threshold for significance was 0.05.|ANOVA|Analysis of variance was conducted with treatment group as a fixed factor.||||1.6|0.2|0.8065
72583865|NCT02861586|144698400|SUPERIORITY||Geometric mean ratio|10.0|||<|0.0001|TWO_SIDED|95.0|3.8|26.6||Pairwise comparisons were adjusted for multiple tests according to Tukey-Kramer. The threshold for significance was 0.05.|ANOVA|Analysis of variance was conducted with treatment group as a fixed factor.||||26.6|3.8|<0.0001
72583866|NCT02861586|144698400|SUPERIORITY||Geometric mean ratio|0.1|||<|0.0001|TWO_SIDED|95.0|0.0|0.3||Pairwise comparisons were adjusted for multiple tests according to Tukey-Kramer. The threshold for significance was 0.05.|ANOVA|Analysis of variance was conducted with treatment group as a fixed factor.||||0.3|0.0|<0.0001
72583867|NCT02861586|144698400|SUPERIORITY||Geometric mean ratio|0.1|||<|0.0001|TWO_SIDED|95.0|0.0|0.3||Pairwise comparisons were adjusted for multiple tests according to Tukey-Kramer. The threshold for significance was 0.05.|ANOVA|Analysis of variance was conducted with treatment group as a fixed factor.||||0.3|0.0|<0.0001
72413143|NCT04153409|144334918|SUPERIORITY||Mean Difference (Net)|-0.89||||0.1488|TWO_SIDED|95.0|-2.11|0.32||No adjustment for multiple comparisons has been made due to the exploratory nature of the study|Mixed Models Analysis||Difference is Active-Placebo|Change from baseline at 2 hours. The change from baseline at 2 hours was extracted from the mixed model analysis including all time points.||0.32|-2.11|0.1488
72551224|NCT03221374|144632659|OTHER|This statistical test is about the correlation between baseline up-down BCI performance and the MAAS score. A linear regression model is used to test if the slope is non-zero.|correlation coefficient|0.41|||<|0.05|TWO_SIDED||||||Regression, Linear|||||||<0.05
72551225|NCT04448678|144632663|OTHER|||||||0.0401|||||||t-test, 2 sided|||||||0.0401
72551226|NCT04448678|144632664|OTHER|||||||0.0049|||||||t-test, 2 sided|||||||0.0049
72551227|NCT04448678|144632665|OTHER|||||||0.297|||||||t-test, 2 sided|||||||0.297
72551228|NCT02567968|144632666|SUPERIORITY|||||||0.002|||||||paired t-test|||||||0.002
72583868|NCT02861586|144698400|SUPERIORITY||Geometric mean ratio|0.1|||<|0.0001|TWO_SIDED|95.0|0.0|0.1||Pairwise comparisons were adjusted for multiple tests according to Tukey-Kramer. The threshold for significance was 0.05.|ANOVA|Analysis of variance was conducted with treatment group as a fixed factor.||||0.1|0.0|<0.0001
72583869|NCT02861586|144698400|SUPERIORITY||Geometric mean ratio|0.4||||0.0011|TWO_SIDED|95.0|0.2|0.8||Pairwise comparisons were adjusted for multiple tests according to Tukey-Kramer. The threshold for significance was 0.05.|ANOVA|Analysis of variance was conducted with treatment group as a fixed factor.||||0.8|0.2|0.0011
72583870|NCT02861586|144698400|SUPERIORITY||Geometric mean ratio|0.2|||<|0.0001|TWO_SIDED|95.0|0.1|0.4||Pairwise comparisons were adjusted for multiple tests according to Tukey-Kramer. The threshold for significance was 0.05.|ANOVA|Analysis of variance was conducted with treatment group as a fixed factor.||||0.4|0.1|<0.0001
72583871|NCT02861586|144698400|SUPERIORITY||Geometric mean ratio|2.6||||0.0718|TWO_SIDED|95.0|1.0|6.9||Pairwise comparisons were adjusted for multiple tests according to Tukey-Kramer. The threshold for significance was 0.05.|ANOVA|Analysis of variance was conducted with treatment group as a fixed factor.||||6.9|1.0|0.0718
72583872|NCT02861586|144698400|SUPERIORITY||Geometric mean ratio|0.4||||0.0593|TWO_SIDED|95.0|0.1|1.0||Pairwise comparisons were adjusted for multiple tests according to Tukey-Kramer. The threshold for significance was 0.05.|ANOVA|Analysis of variance was conducted with treatment group as a fixed factor.||||1.0|0.1|0.0593
72583873|NCT02861586|144698400|SUPERIORITY||Gemetric mean ratio|0.4||||0.0593|TWO_SIDED|95.0|0.1|1.0||Pairwise comparisons were adjusted for multiple tests according to Tukey-Kramer. The threshold for significance was 0.05.|ANOVA|Analysis of variance was conducted with treatment group as a fixed factor.||||1.0|0.1|0.0593
72583874|NCT02861586|144698400|SUPERIORITY||Geometric mean ratio|5.2|||<|0.0001|TWO_SIDED|95.0|2.6|10.4||Pairwise comparisons were adjusted for multiple tests according to Tukey-Kramer. The threshold for significance was 0.05.|ANOVA|Analysis of variance was conducted with treatment group as a fixed factor.||||10.4|2.6|<0.0001
72583875|NCT02861586|144698400|SUPERIORITY||Geometric mean ratio|2.2||||0.2005|TWO_SIDED|95.0|0.8|5.7||Pairwise comparisons were adjusted for multiple tests according to Tukey-Kramer. The threshold for significance was 0.05.|ANOVA|Analysis of variance was conducted with treatment group as a fixed factor.||||5.7|0.8|0.2005
72583876|NCT02861586|144698400|SUPERIORITY||Geometric mean ratio|35.0|||<|0.0001|TWO_SIDED|95.0|13.1|93.1||Pairwise comparisons were adjusted for multiple tests according to Tukey-Kramer. The threshold for significance was 0.05.|ANOVA|Analysis of variance was conducted with treatment group as a fixed factor.||||93.1|13.1|<0.0001
72583877|NCT02861586|144698400|SUPERIORITY||Geometric mean ratio|0.0|||<|0.0001|TWO_SIDED|95.0|0.0|0.1||Pairwise comparisons were adjusted for multiple tests according to Tukey-Kramer. The threshold for significance was 0.05.|ANOVA|Analysis of variance was conducted with treatment group as a fixed factor.||||0.1|0.0|<0.0001
72583878|NCT02861586|144698400|SUPERIORITY||Geometric mean ratio|0.0|||<|0.0001|TWO_SIDED|0.0|0.0|0.1|||ANOVA|Analysis of variance was conducted with treatment group as a fixed factor.||||0.1|0.0|<0.0001
72583879|NCT02861586|144698400|SUPERIORITY||Geometric mean ratio|0.4||||0.1138|TWO_SIDED|95.0|0.2|1.1||Pairwise comparisons were adjusted for multiple tests according to Tukey-Kramer. The threshold for significance was 0.05.|ANOVA|Analysis of variance was conducted with treatment group as a fixed factor.||||1.1|0.2|0.1138
72583880|NCT02861586|144698400|SUPERIORITY||Geometric mean ratio|6.7|||<|0.0001|TWO_SIDED|95.0|2.5|18.1||Pairwise comparisons were adjusted for multiple tests according to Tukey-Kramer. The threshold for significance was 0.05.|ANOVA|Analysis of variance was conducted with treatment group as a fixed factor.||||18.1|2.5|<0.0001
72583881|NCT02861586|144698400|SUPERIORITY||Geometric mean ratio|0.1|||<|0.0001|TWO_SIDED|95.0|0.1|0.4||Pairwise comparisons were adjusted for multiple tests according to Tukey-Kramer. The threshold for significance was 0.05.|ANOVA|Analysis of variance was conducted with treatment group as a fixed factor.||||0.4|0.1|<0.0001
72583882|NCT02861586|144698400|SUPERIORITY||Geometric mean ratio|0.1|||<|0.0001|TWO_SIDED|95.0|0.1|0.4||Pairwise comparisons were adjusted for multiple tests according to Tukey-Kramer. The threshold for significance was 0.05.|ANOVA|Analysis of variance was conducted with treatment group as a fixed factor.||||0.4|0.1|<0.0001
72583883|NCT02861586|144698400|SUPERIORITY||Geometric mean ratio|16.0|||<|0.0001|TWO_SIDED|95.0|4.9|52.4||Pairwise comparisons were adjusted for multiple tests according to Tukey-Kramer. The threshold for significance was 0.05.|ANOVA|Analysis of variance was conducted with treatment group as a fixed factor.||||52.4|4.9|<0.0001
72583884|NCT02861586|144698400|SUPERIORITY||Geometric mean ratio|0.1|||<|0.0001|TWO_SIDED|95.0|0.0|0.2||Pairwise comparisons were adjusted for multiple tests according to Tukey-Kramer. The threshold for significance was 0.05.|ANOVA|Analysis of variance was conducted with treatment group as a fixed factor.||||0.2|0.0|<0.0001
72583885|NCT02861586|144698400|SUPERIORITY||Geometric mean ratio|0.1|||<|0.0001|TWO_SIDED|95.0|0.0|0.2||Pairwise comparisons were adjusted for multiple tests according to Tukey-Kramer. The threshold for significance was 0.05.|ANOVA|Analysis of variance was conducted with treatment group as a fixed factor.||||0.2|0.0|<0.0001
72583886|NCT02861586|144698400|SUPERIORITY||Geometric mean ratio|1.0||||1|TWO_SIDED|95.0|0.3|3.3||Pairwise comparisons were adjusted for multiple tests according to Tukey-Kramer. The threshold for significance was 0.05.|ANOVA|Analysis of variance was conducted with treatment group as a fixed factor.||||3.3|0.3|1.0000
72583887|NCT02861586|144698400|SUPERIORITY||Geometric mean ratio|1.0||||1|TWO_SIDED|95.0|0.3|3.3||Pairwise comparisons were adjusted for multiple tests according to Tukey-Kramer. The threshold for significance was 0.05.|ANOVA|Analysis of variance was conducted with treatment group as a fixed factor.||||3.3|0.3|1.0000
72583888|NCT02861586|144698400|SUPERIORITY||Geometric mean ratio|1.0||||1|TWO_SIDED|95.0|0.3|3.2||Pairwise comparisons were adjusted for multiple tests according to Tukey-Kramer. The threshold for significance was 0.05.|ANOVA|Analysis of variance was conducted with treatment group as a fixed factor.||||3.2|0.3|1.0000
72583889|NCT02861586|144698409|SUPERIORITY||Geometric mean ratio|0.9||||0.9775|TWO_SIDED|95.0|0.4|2.0|||ANOVA|Analysis of variance was performed with baseline measles titer group as a fixed factor.||||2.0|0.4|0.9775
72551229|NCT02016170|144632675|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was assessed using a 95% confidence interval (CI) of the difference in mean PRU between prasugrel and ticagrelor (two arms combined). Under the assumption of 0 difference in mean PRU between ticagrelor 90 mg bid MD and prasugrel 10 mg qd MD and a common standard deviation of 60 PRU, a sample size of 24 patients per group allowed for the 95% CI to stay within ± 45 PRU with a 90% power and alpha=0.05.|Mean Difference (Final Values)|-18.0|||||TWO_SIDED|95.0|-41.0|5.0||||||||5|-41|
72551230|NCT02016170|144632676|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was assessed using a 95% confidence interval (CI) of the difference in mean PRU between prasugrel and ticagrelor (two arms combined).|Mean Difference (Final Values)|-11.0|||||TWO_SIDED|95.0|-18.0|-4.0||||||||-4|-18|
72551231|NCT00336479|144632677|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.985||||0.0014|TWO_SIDED|95.0|1.525|5.842|||Regression, Logistic|Treatment, weight, race and baseline HCV RNA as factors||||5.842|1.525|0.0014
72413144|NCT04153409|144334918|SUPERIORITY||Mean Difference (Net)|-0.36||||0.5644|TWO_SIDED|95.0|-1.57|0.86||No adjustment for multiple comparisons has been made due to the exploratory nature of the study|Mixed Models Analysis||Difference is Active-Placebo|Change from baseline at 4 hours. The change from baseline at 4 hours was extracted from the mixed model analysis including all time points.||0.86|-1.57|0.5644
72413145|NCT04153409|144334918|SUPERIORITY||Mean Difference (Net)|-0.7||||0.2561|TWO_SIDED|95.0|-1.91|0.51||No adjustment for multiple comparisons has been made due to the exploratory nature of the study|Mixed Models Analysis||Difference is Active-Placebo|Change from baseline at 8 hours, The change from baseline at 8 hours was extracted from the mixed model analysis including all time points.||0.51|-1.91|0.2561
72551232|NCT00336479|144632677|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.17||||0.0204|TWO_SIDED|95.0|1.127|4.178|||Regression, Logistic|||||4.178|1.127|0.0204
72551233|NCT00336479|144632678|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.586||||0.0051|TWO_SIDED|95.0|1.331|5.025|||Regression, Logistic|||||5.025|1.331|0.0051
72551234|NCT00336479|144632678|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.976||||0.0418|TWO_SIDED|95.0|1.026|3.807|||Regression, Logistic|||||3.807|1.026|0.0418
72551235|NCT02597101|144632690|OTHER|REML mixed model|REML mixed model|0.05|||<|0.05|TWO_SIDED|||||Using REML mixed model analysis, differences between study arms resulting in a p\<0.05 would represent statistically-significant differences.|REML mixed model|||The primary efficacy endpoint is the improvement of insulin sensitivity by 40% or greater at 6 months compared to baseline, assessed by the hyperinsulinemic-euglycemic clamp method.||||<0.05
72551236|NCT01395030|144632701|OTHER||||||||||||||||||"Analysis was performed using Gene Set Enrichment Analysis (GSEA version 19.0.24, Broad Institute, Cambridge, MA) implemented in GenePattern (Broad Institute, Cambridge, MA) by uploading expression array data to this cloud-computing genomics platform. The specific details of this statistical approach can be found in the following publicly available references:~Reich M, Liefeld T, Gould J, Lerner J, Tamayo P, Mesirov JP. GenePattern 2.0 Nature Genetics 38 no. 5 (2006): pp500-501~Subramanian A, Tamayo P, Mootha VK, Mukherjee S, Ebert BL, Gillette MA, Paulovich A, Pomeroy SL, Golub TR, Lander ES, Mesirov JP. Gene set enrichment analysis: A knowledge-based approach for interpreting genome-wide expression profiles. PNAS. 2005;102(43);15545-15550."|||
72551237|NCT02079766|144632704|OTHER|||||||0.2959||||||No adjustments for multiple comparisons or multiplicity were made for this study. No a priori threshold for significance was chosen.|Fisher Exact|||Evaluated the association between the overall brain uptake and the study group||||0.2959
72551238|NCT02079766|144632705|OTHER|||||||0.5163||||||No adjustments for multiple comparisons or multiplicity were made for this study. No a priori threshold for significance was chosen.|ANOVA|MMSE score as the response variable and flortaucipir uptake score (4 levels) as the fixed effect||Measured differences in clinical presentation using MMSE between subjects with no visual flortaucipir uptake, and those with mild uptake.||||0.5163
72551239|NCT04166032|144632732|OTHER|||||||0.21|||||||t-test, 2 sided|||||||0.210
72551240|NCT01569152|144632749|SUPERIORITY_OR_OTHER||Difference of percentages|43.9|||<|0.001|TWO_SIDED|95.0|24.52|63.28|||Cochran-Mantel-Haenszel|||||63.28|24.52|<0.001
72551241|NCT01569152|144632750|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.98|||<|0.001|TWO_SIDED|95.0|-1.53|-0.43|||Constrained Longitudinal Data Analysis|||||-0.43|-1.53|<0.001
72551242|NCT01569152|144632751|SUPERIORITY_OR_OTHER||Difference in least squares means|-1.11|||<|0.001|TWO_SIDED|95.0|-1.62|-0.6|||Constrained Longitudinal Data Analysis|||||-0.60|-1.62|<0.001
72551243|NCT01569152|144632752|SUPERIORITY_OR_OTHER||Difference in percentages|14.63||||0.044|TWO_SIDED|95.0|0.83|28.44|||Cochran-Mantel-Haenszel|||||28.44|0.83|0.044
72551244|NCT01569152|144632755|SUPERIORITY_OR_OTHER||Difference in percentages|31.71||||0.004|TWO_SIDED|95.0|11.29|52.13|||Cochran-Mantel-Haenszel|||||52.13|11.29|0.004
72551245|NCT01569152|144632756|SUPERIORITY_OR_OTHER||Difference in percentages|29.27||||0.007|TWO_SIDED|95.0|8.9|49.63|||Cochran-Mantel-Haenszel|||||49.63|8.90|0.007
72551246|NCT01569152|144632757|SUPERIORITY_OR_OTHER||Difference in percentages|9.76||||0.039|TWO_SIDED|95.0|0.67|18.84|||Cochran-Mantel-Haenszel|||||18.84|0.67|0.039
72551247|NCT01569152|144632758|SUPERIORITY_OR_OTHER||Difference in percentages|12.2||||0.018|TWO_SIDED|95.0|2.18|22.21|||Cochran-Mantel-Haenszel|||||22.21|2.18|0.018
72551248|NCT01569152|144632761|SUPERIORITY_OR_OTHER||Difference in least squares means|-4.75||||0.028|TWO_SIDED|95.0|-8.99|-0.52|||Constrained Longitudinal Data Analysis|||||-0.52|-8.99|0.028
72551249|NCT01569152|144632762|SUPERIORITY_OR_OTHER||Difference in least squares means|-2.65||||0.11|TWO_SIDED|95.0|-5.91|0.62|||Constrained Longitudinal Data Analysis|||||0.62|-5.91|0.110
72551250|NCT01569152|144632763|SUPERIORITY_OR_OTHER||Difference in least squares means|-10.56||||0.002|TWO_SIDED|95.0|-16.97|-4.15|||Constrained Longitudinal Data Analysis|||||-4.15|-16.97|0.002
72551251|NCT01569152|144632766|SUPERIORITY_OR_OTHER||Difference in least squares means|-20.84|||<|0.001|TWO_SIDED|95.0|-29.98|-11.71|||Constrained Longitudinal Data Analysis|||||-11.71|-29.98|<0.001
72551252|NCT01569152|144632767|SUPERIORITY_OR_OTHER||Difference in least squares means|-19.48|||<|0.001|TWO_SIDED|95.0|-29.69|-9.28|||Constrained Longitudinal Data Analysis|||||-9.28|-29.69|<0.001
72551253|NCT01569152|144632768|SUPERIORITY_OR_OTHER||Difference in least squares means|-20.69|||<|0.001|TWO_SIDED|95.0|-31.29|-10.09|||Constrained Longitudinal Data Analysis|||||-10.09|-31.29|<0.001
72551254|NCT01569152|144632769|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.62|||<|0.001|TWO_SIDED|95.0|-0.84|-0.4|||Constrained Longitudinal Data Analysis|||||-0.40|-0.84|< 0.001
72551255|NCT01569152|144632770|SUPERIORITY_OR_OTHER||Difference in least squares means|-1.59||||0.007|TWO_SIDED|95.0|-2.73|-0.45|||Constrained Longitudinal Data Analysis|||||-0.45|-2.73|0.007
72551256|NCT01569152|144632771|SUPERIORITY_OR_OTHER||Difference in least squares means|-4.9||||0.315|TWO_SIDED|95.0|-14.54|4.74|||Constrained Longitudinal Data Analysis|||||4.74|-14.54|0.315
72551257|NCT01569152|144632773|SUPERIORITY_OR_OTHER||Difference in percentages|31.71|||<|0.001|TWO_SIDED|95.0|15.56|47.86|||Cochran-Mantel-Haenszel|||||47.86|15.56|<0.001
72551258|NCT00154102|144632798|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.853||||0.0479|TWO_SIDED|95.0|0.728|1.0|||Stratified log rank|Kaplan-Meier method was used to estimate median PFS time. HR was calculated using Cox proportional hazards model stratified by randomization strata.||The study was planned with 633 progression events, in order to provide 80% power to test the null hypothesis of no difference in PFS time between treatment groups, assuming a hazard ratio (HR) of 0.8 of cetuximab + chemotherapy (CTX) over CTX alone. Significance level was fixed at 5%. The two-sided stratified log-rank test was employed, considering the randomization strata (region: Western Europe, Eastern Europe, outside Europe and Karnovsky Performance Scale (KPS):\<80 vs. ≥80)||1.000|0.728|0.0479
72583890|NCT02861586|144698409|SUPERIORITY||Geometric mean ratio|1.3||||0.8366|TWO_SIDED|95.0|0.6|3.1|||ANOVA|Analysis of variance was performed with baseline measles titer group as a fixed factor.||||3.1|0.6|0.8366
72583891|NCT02861586|144698409|SUPERIORITY||Geometric mean ratio|1.5||||0.5625|TWO_SIDED|95.0|0.7|3.6|||ANOVA|Analysis of variance was performed with baseline measles titer group as a fixed factor.||||3.6|0.7|0.5625
72583892|NCT02861586|144698409|SUPERIORITY||Geometric mean ratio|1.5||||0.5924|TWO_SIDED|95.0|0.6|3.5|||ANOVA|Analysis of variance was performed with baseline measles titer group as a fixed factor.||||3.5|0.6|0.5924
72583893|NCT02861586|144698409|SUPERIORITY||Geometric mean ratio|1.8||||0.3122|TWO_SIDED|95.0|0.8|4.1|||ANOVA|Analysis of variance was performed with baseline measles titer group as a fixed factor.||||4.1|0.8|0.3122
72583894|NCT02861586|144698409|SUPERIORITY||Geometric mean ratio|1.2||||0.9665|TWO_SIDED|95.0|0.5|2.8|||ANOVA|Analysis of variance was performed with baseline measles titer group as a fixed factor.||||2.8|0.5|0.9665
72583895|NCT05161481|144698419|OTHER|"The adjusted mean values for percentage change at Week 24 are derived for each group using the MMRM. The mean difference for the Comparison vs Placebo, is the adjusted mean of the treatment group subtracted from the adjusted mean of the placebo group."|Difference of adjusted means|-8.4|STANDARD_ERROR_OF_MEAN|8.9|||TWO_SIDED|95.0|-26.25|9.45||||||Model includes baseline HVPG as linear covariate and treatment and use of NSBBs or carvedilol as fixed effects, treatment by visit interaction and baseline HVPG by visit interaction. The following covariance structure has been used to fit the mixed model: Unstructured.||9.45|-26.25|
72583896|NCT05161481|144698419|OTHER|"The adjusted mean values for percentage change at Week 24 are derived for each group using the MMRM. The mean difference for the Comparison vs Placebo, is the adjusted mean of the treatment group subtracted from the adjusted mean of the placebo group."|Difference of adjusted means|-14.18|STANDARD_ERROR_OF_MEAN|9.93|||TWO_SIDED|95.0|-34.09|5.72||||||Model includes baseline HVPG as linear covariate and treatment and use of NSBBs or carvedilol as fixed effects, treatment by visit interaction and baseline HVPG by visit interaction. The following covariance structure has been used to fit the mixed model: Unstructured.||5.72|-34.09|
72583897|NCT05161481|144698420|OTHER|"The adjusted mean values for percentage change at Week 8 are derived for each group using the MMRM. The mean difference for the Comparison vs Placebo, is the adjusted mean of the treatment group subtracted from the adjusted mean of the placebo group."|Difference of adjusted means|3.51|STANDARD_ERROR_OF_MEAN|6.23|||TWO_SIDED|95.0|-8.94|15.96||||||The analysis of covariance (ANCOVA) model includes baseline hepatic venous pressure gradient (HVPG) as a linear covariate, with treatment and use of non-selective beta-blockers (NSBBs) or carvedilol as fixed effects. All intercurrent events (ICEs) will be handled using the treatment policy for the primary objective as a sensitivity analysis. That is, all data collected after the intercurrent events will be included in the analysis.||15.96|-8.94|
72583898|NCT05161481|144698420|OTHER|"The adjusted mean values for percentage change at Week 8 are derived for each group using the MMRM. The mean difference for the Comparison vs Placebo, is the adjusted mean of the treatment group subtracted from the adjusted mean of the placebo group."|Difference of adjusted means|2.69|STANDARD_ERROR_OF_MEAN|6.82|||TWO_SIDED|95.0|-10.94|16.33||||||ANCOVA) model includes baseline hepatic venous pressure gradient (HVPG) as a linear covariate, with treatment and use of non-selective beta-blockers (NSBBs) or carvedilol as fixed effects. All intercurrent events (ICEs) will be handled using the treatment policy for the primary objective as a sensitivity analysis. That is, all data collected after the intercurrent events will be included in the analysis.||16.33|-10.94|
72583899|NCT04225715|144698428|SUPERIORITY||Difference in Response Rate|7.2|||||TWO_SIDED|95.0|-2.1|16.4|||||95% CI for difference of two proportions was calculated using Cochran-Mantel-Haenszel (CMH) method.|||16.4|-2.1|
72583900|NCT04225715|144698428|SUPERIORITY||Difference in Response Rate|3.5|||||TWO_SIDED|95.0|-3.1|10.0|||||95% CI for difference of two proportions was calculated using CMH method.|||10|-3.1|
72583901|NCT04225715|144698428|SUPERIORITY||Difference in Response Rate|24.3|||||TWO_SIDED|95.0|9.0|39.5|||||95% CI for difference of two proportions was calculated using CMH method.|||39.5|9|
72583902|NCT04225715|144698428|SUPERIORITY||Difference in Response Rate|12.3|||||TWO_SIDED|95.0|1.3|23.3|||||95% CI for difference of two proportions was calculated using CMH method.|||23.3|1.3|
72583903|NCT04225715|144698428|SUPERIORITY||Difference in Response Rate|0.0|||||TWO_SIDED|95.0|0.0|0.0|||||95% CI for difference of two proportions was calculated using CMH method.|||0|0|
72583904|NCT04225715|144698428|SUPERIORITY||Difference in Response Rate|6.7|||||TWO_SIDED|95.0|-2.2|15.7|||||95% CI for difference of two proportions was calculated using CMH method.|||15.7|-2.2|
72583905|NCT04225715|144698429|SUPERIORITY||6.2|6.2|||||TWO_SIDED|95.0|-2.0|14.5|||||95% CI for difference of two proportions was calculated using CMH method.|Combo 7: Week 24||14.5|-2|
72583906|NCT04225715|144698429|SUPERIORITY||Difference in Response Rate|13.4|||||TWO_SIDED|95.0|1.2|25.6|||||95% CI for difference of two proportions was calculated using CMH method.|Combo 8: Week 36||25.6|1.2|
72583907|NCT04225715|144698429|SUPERIORITY||Difference in Response Rate|7.2|||||TWO_SIDED|95.0|-2.1|16.4|||||95% CI for difference of two proportions was calculated using CMH method.|Combo 2: Week 48||16.4|-2.1|
72583908|NCT04225715|144698429|SUPERIORITY||Difference in Response Rate|3.5|||||TWO_SIDED|95.0|-3.1|10.0|||||95% CI for difference of two proportions was calculated using CMH method.|Combo 3: Week 48||10|-3.1|
72583909|NCT04225715|144698429|SUPERIORITY||Difference in Response Rate|31.2|||||TWO_SIDED|95.0|14.7|47.6|||||95% CI for difference of two proportions was calculated using CMH method.|Combo 4: Week 48||47.6|14.7|
72583910|NCT04225715|144698429|SUPERIORITY||Difference in Response Rate|18.4|||||TWO_SIDED|95.0|5.4|31.4|||||95% CI for difference of two proportions was calculated using CMH method.|Combo 6: Week 48||31.4|5.4|
72583911|NCT04225715|144698429|SUPERIORITY||Difference in Response Rate|8.1|||||TWO_SIDED|95.0|-3.9|20.1|||||95% CI for difference of two proportions was calculated using CMH method.|Combo 2: FUW 48||20.1|-3.9|
72583912|NCT04225715|144698429|SUPERIORITY||Difference in Response Rate|-2.7|||||TWO_SIDED|95.0|-8.1|2.7|||||95% CI for difference of two proportions was calculated using CMH method.|Combo 3: FUW 48||2.7|-8.1|
72583913|NCT04225715|144698429|SUPERIORITY||Difference in Response Rate|14.6|||||TWO_SIDED|95.0|0.4|28.8|||||95% CI for difference of two proportions was calculated using CMH method.|Combo 4: FUW 48||28.8|0.4|
72583914|NCT04225715|144698429|SUPERIORITY||Difference in Response Rate|9.5|||||TWO_SIDED|95.0|-2.5|21.5|||||95% CI for difference of two proportions was calculated using CMH method.|Combo 6: FUW 48||21.5|-2.5|
72583915|NCT05251337|144698453|SUPERIORITY|||||||0.462|||||||Mixed Models Analysis|||||||0.462
72583916|NCT05251337|144698454|SUPERIORITY|||||||0.285|||||||Mixed Models Analysis|||||||0.285
72583917|NCT05251337|144698456|SUPERIORITY|||||||0.091|||||||t-test, 2 sided|||||||0.091
72583918|NCT00471081|144698468|SUPERIORITY||Percentage of subjects with hSBA titers|88.4|||||TWO_SIDED|95.0|81.9|93.2|||||Immunogenecity of GSK134612 was demonstrated if the lower limit (LL) of the 2-sided exact 95% confidence interval (CI) was higher than the pre-defined clinical limit of 80%.|To demonstrate the immunogenicity of GSK134612 administered on a 2-dose schedule at 9 and 12 months of age with respect to serum bactericidal assay using human complement (hSBA) titers ≥1:8 for each discrete N. meningitidis serogroup A.||93.2|81.9|
72583919|NCT00471081|144698468|SUPERIORITY||Percentage of subjects with hSBA titers|100.0|||||TWO_SIDED|95.0|97.3|100.0|||||Immunogenecity of GSK134612 was demonstrated if the lower limit (LL) of the 2-sided exact 95% confidence interval (CI) was higher than the pre-defined clinical limit of 90%.|To demonstrate the immunogenicity of GSK134612 administered on a 2-dose schedule at 9 and 12 months of age with respect to serum bactericidal assay using human complement (hSBA) titers ≥1:8 for each discrete N. meningitidis serogroup C.||100|97.3|
72583920|NCT00471081|144698468|SUPERIORITY||Percentage of subjects with hSBA titers|99.3|||||TWO_SIDED|95.0|96.2|100.0|||||Immunogenecity of GSK134612 was demonstrated if the lower limit (LL) of the 2-sided exact 95% confidence interval (CI) was higher than the pre-defined clinical limit of 80%.|To demonstrate the immunogenicity of GSK134612 administered on a 2-dose schedule at 9 and 12 months of age with respect to serum bactericidal assay using human complement (hSBA) titers ≥1:8 for each discrete N. meningitidis serogroup W-135.||100|96.2|
72583921|NCT00471081|144698468|SUPERIORITY||Percentage of subjects with hSBA titers|99.3|||||TWO_SIDED|95.0|96.2|100.0|||||Immunogenecity of GSK134612 was demonstrated if the lower limit (LL) of the 2-sided exact 95% confidence interval (CI) was higher than the pre-defined clinical limit of 80%.|To demonstrate the immunogenicity of GSK134612 administered on a 2-dose schedule at 9 and 12 months of age with respect to serum bactericidal assay using human complement (hSBA) titers ≥1:8 for each discrete N. meningitidis serogroup Y.||100|96.2|
72583922|NCT01256450|144698524|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.14||||0.587|TWO_SIDED|95.0|-0.646|0.366|||ANCOVA|||||0.366|-0.646|.5870
72583923|NCT03889418|144698540|SUPERIORITY||Odds Ratio, log|-0.009|STANDARD_ERROR_OF_MEAN|0.153||0.956|TWO_SIDED|95.0|-0.309|0.292|||Mixed Models Analysis|||||0.292|-0.309|0.956
72583924|NCT03889418|144698541|SUPERIORITY||Risk Ratio, log|-0.103|STANDARD_ERROR_OF_MEAN|0.05||0.039|TWO_SIDED|95.0|-0.2|-0.005|||Mixed Models Analysis|||||-.005|-0.200|0.039
72583925|NCT03889418|144698542|SUPERIORITY||Rate Ratio, log|0.049|STANDARD_ERROR_OF_MEAN|0.282||0.864|TWO_SIDED|95.0|-0.506|0.603|||Mixed Models Analysis|||||0.603|-0.506|0.864
72583926|NCT03889418|144698543|SUPERIORITY||rate ratio, log|0.018|STANDARD_ERROR_OF_MEAN|0.148||0.901|TWO_SIDED|95.0|-0.272|0.308|||Mixed Models Analysis|||||0.308|-0.272|0.901
72583927|NCT00204490|144698571|OTHER|||||||0.071|||||||t-test, 2 sided|||(FGBT% at 1 year of treatment minus FGBT% at baseline) divided by FGBT% at baseline.||||0.071
72583928|NCT00204490|144698571|OTHER|||||||0.08|||||||t-test, 2 sided|||(FGBT% at 2 year of treatment minus FGBT% at baseline) divided by FGBT% at baseline.||||0.080
72583929|NCT00204490|144698571|OTHER||Slope|-0.107|STANDARD_ERROR_OF_MEAN|0.045||0.019|TWO_SIDED||||||Regression, Linear|Mixed model|slope for interaction of treatment and time, placebo was the reference group; square root transformed outcome.|Intention to treat||||0.019
72583930|NCT02166333|144698582|SUPERIORITY||Hazard Ratio (HR)|0.94||||0.54|TWO_SIDED|95.0|0.76|1.15||The P value is nominal and two-sided.|Log Rank||The Experience on Best Dose versus 200 IU/day hazard ratio and its 95% confidence interval were derived from a Cox regression model with dose group as the single model variable.|The Experience on Best Dose group includes all participants assigned or switched to best dose (1000 IU/day) and excludes 41 participants randomized to 2000 or 4000 IU/day who were never issued a bottle of best dose. For those randomized to 2000 or 4000 IU/day, at-risk time and events are measured from the date of their switch to best dose. 150 Experience on Best Dose participants (median follow-up, 10.2 mos) and 125 200 IU/day participants (median follow-up, 20.3 mos) were censored.||1.15|0.76|0.54
72583931|NCT02166333|144698582|SUPERIORITY||Hazard Ratio (HR)|1.04|||||TWO_SIDED|95.0|0.86|1.25|||||The comparison of the Pooled Higher Doses group versus the 200 IU/d group is a sensitivity analysis.|||1.25|0.86|
72583932|NCT02166333|144698583|SUPERIORITY|The overall P tests for difference between groups in differential change from baseline over time and is from a 3 degree of freedom test of the combined 3 treatment-by-time interaction terms from the longitudinal mixed effects model.||||||0.15||||||The P value is nominal and not adjusted for multiple comparisons.|Regression, Linear|3 degree of freedom interaction test||The two groups were assessed for differential change over time in change from baseline using a longitudinal mixed effects regression model with gait speed as the outcome and fixed effects including a single treatment term, 3 time point terms and 3 treatment-by-time interaction terms and a random intercept for participant.||||0.15
72583933|NCT00503698|144698584|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.97||||0.91|TWO_SIDED|95.0|0.6|1.57|||Regression, Cox|Time to all-cause death analysed using stratified Cox regression model with treatment and sex as fixed factors, age and time in dialysis as covariates||||1.57|0.60|0.91
72583934|NCT00503698|144698585|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.88||||0.4977|TWO_SIDED|95.0|0.6|1.28|||Regression, Cox|Time to all-cause death analysed using stratified Cox regression model with treatment and sex as fixed factors, age and time in dialysis as covariates||||1.28|0.60|0.4977
72583935|NCT00503698|144698586|SUPERIORITY_OR_OTHER||Rate ratio|1.13||||0.4409|TWO_SIDED|95.0|0.83|1.53|||Negative binomial regression|||||1.53|0.83|0.4409
72583936|NCT00359424|144698606|SUPERIORITY_OR_OTHER||Risk Difference (RD)|1.5||||0.7031|TWO_SIDED|95.0|-6.1|9.1||The CMH statistic is tested at the two-sided alpha level of 0.05. For the interim analyses of the primary efficacy analysis, the alpha spending function method (Lan and DeMets, 1987) with O'Brien and Fleming (1979) stopping boundaries were adopted.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusting for the dichotomized baseline NIHSS score (\<20 or ≥20).|Positive adjusted risk difference indicates greater risk in the Endovascular group, while negative adjusted risk difference indicates greater risk in the IV Only group.|Test of null hypothesis (equal proportions of subjects with mRS of 0-2 at 90 days post-randomization in IV Only and Endovascular treatment arms) versus alternative hypothesis (unequal proportions of subjects with mRS of 0-2 at 90 days post-randomization in IV Only and Endovascular treatment arms).||9.1|-6.1|.7031
72583937|NCT00359424|144698607|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-2.0||||0.5241|TWO_SIDED|99.0|-10.3|6.2||The CMH statistic is tested at the two-sided alpha level of 0.01.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusting for the dichotomized baseline NIHSS score (\<20 or ≥20).|Positive adjusted risk difference indicates greater risk in the Endovascular group, while negative adjusted risk difference indicates greater risk in the IV Only group.|Test of null hypothesis (equal proportions of subjects with mortality within 90 days post-randomization in IV Only and Endovascular treatment arms) versus alternative hypothesis (unequal proportions of subjects with mortality within 90 days post-randomization in IV Only and Endovascular treatment arms).||6.2|-10.3|.5241
72583938|NCT00359424|144698608|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.4||||0.8275|TWO_SIDED|99.0|-4.6|5.5||The CMH statistic is tested at the two-sided alpha level of 0.01.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusting for the dichotomized baseline NIHSS score (\<20 or ≥20).|Positive adjusted risk difference indicates greater risk in the Endovascular group, while negative adjusted risk difference indicates greater risk in the IV Only group.|Test of null hypothesis (equal proportions of subjects with sICH within 30 hours post IV tPA initiation in IV Only and Endovascular treatment arms) versus alternative hypothesis (unequal proportions of subjects with sICH within 30 hours post IV tPA initiation in IV Only and Endovascular treatment arms).||5.5|-4.6|.8275
72583939|NCT03830333|144698653|NON_INFERIORITY|Ceftolozane/tazobactam + metronidazole is concluded to be non-inferior to meropenem + placebo if the lower bound of the 95% CI for the treatment difference in percent response is above -12.5 percentage points.|Difference in percentages|2.1|||||TWO_SIDED|95.0|-4.7|8.8||||||Difference in percentage was based on Miettinen and Nurminen method with the Cochran-Mantel-Haenszel (CMH) weighting stratified by anatomic site of infection (bowel \[small or large\] versus other site of cIAI).||8.8|-4.7|
72583940|NCT03830333|144698654|OTHER||Difference in percentages|-4.4|||||TWO_SIDED|95.0|-12.6|3.7||||||Difference in percentage was based on Miettinen and Nurminen method with the CMH weighting stratified by anatomic site of infection (bowel \[small or large\] versus other site of cIAI).||3.7|-12.6|
72583941|NCT03830333|144698655|OTHER||Difference in percentages|1.4|||||TWO_SIDED|95.0|-3.8|6.7||||||Difference in percentage was based on Miettinen and Nurminen method with the CMH weighting stratified by anatomic site of infection (bowel \[small or large\] versus other site of cIAI).||6.7|-3.8|
72583942|NCT03830333|144698656|OTHER||Difference in percentages|-1.5|||||TWO_SIDED|95.0|-8.0|4.8||||||Difference in percentage was based on Miettinen and Nurminen method with the CMH weighting stratified by anatomic site of infection (bowel \[small or large\] versus other site of cIAI).||4.8|-8.0|
72583943|NCT03830333|144698657|OTHER||Difference in percentages|1.2|||||TWO_SIDED|95.0|-9.2|10.4||||||Difference in percentage based on Miettinen and Nurminen method with the CMH weighting stratified by anatomic site of infection (bowel \[small or large\] versus other site of cIAI).||10.4|-9.2|
72583944|NCT03830333|144698658|OTHER|Difference in percentage was based on unstratified Miettinen and Nurminen method. Confidence Interval is displayed only when there are at least 4 participants in at least one treatment group.|Difference in percentages|-1.0|||||TWO_SIDED|95.0|-11.9|8.7||||||Gram-negative aerobes comparison: Based on unstratified Miettinen and Nurminen method.||8.7|-11.9|
72583945|NCT03830333|144698658|OTHER|Difference in percentage was based on unstratified Miettinen and Nurminen method. Confidence Interval is displayed only when there are at least 4 participants in at least one treatment group.|Difference in percentages|-1.2|||||TWO_SIDED|95.0|-12.5|8.5||||||All enterobacteriaceae comparison: Based on unstratified Miettinen and Nurminen method.||8.5|-12.5|
72583946|NCT03830333|144698658|OTHER|Difference in percentage was based on unstratified Miettinen and Nurminen method. Confidence Interval is displayed only when there are at least 4 participants in at least one treatment group.|Difference in percentages|-8.2|||||TWO_SIDED|95.0|-42.2|20.0||||||Gram-positive aerobes comparison: Based on unstratified Miettinen and Nurminen method.||20.0|-42.2|
72583947|NCT03830333|144698659|OTHER||Difference in Percentages|-0.7|||||TWO_SIDED|95.0|-12.6|11.2||||||Difference in percentage was based on Miettinen \& Nurminen method.||11.2|-12.6|
72583948|NCT03830333|144698660|OTHER||Difference in Percentages|0.0|||||TWO_SIDED|95.0|-4.4|4.4||||||Difference in percentage was based on Miettinen \& Nurminen method.||4.4|-4.4|
72583949|NCT03805412|144698667|SUPERIORITY|||||||0.694|||||||t-test, 2 sided|||||||0.694
72583950|NCT05514873|144698688|NON_INFERIORITY|Non-inferiority of Week 12 MG-ADL over Baseline was shown if the upper limit of the 2-sided 95% confidence interval (CI) is less than 2.|||||<|0.001|||||||Mixed Model for Repeated Measures (MMRM)|||||||<0.001
72413146|NCT04153409|144334918|SUPERIORITY||Mean Difference (Net)|-0.01||||0.9875|TWO_SIDED|95.0|-1.22|1.2||No adjustment for multiple comparisons has been made due to the exploratory nature of the study|Mixed Models Analysis||Difference is Active-Placebo|Change from baseline at 24 hours. The change from baseline at 24 hours was extracted from the mixed model analysis including all time points.||1.20|-1.22|0.9875
72551259|NCT00154102|144632799|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.696||||0.0012|TWO_SIDED|95.0|0.558|0.867|||Stratified log rank|Kaplan-Meier method was used to estimate median PFS time. HR was calculated using Cox proportional hazards model stratified by randomization strata.||The two-sided stratified log-rank test was employed at the 5% significance level, considering the randomization strata (region: Western Europe, Eastern Europe, outside Europe and KPS:\<80 vs. ≥80)||0.867|0.558|0.0012
72583951|NCT07091916|144698709|OTHER|This objective was for the purpose of gathering data pertaining to device safety over the first 2 weeks post-implant. There were no pre-specified performance criteria or hypotheses for this objective.|Proportion|92.9|||||TWO_SIDED||||||descriptive statistics|||The first primary objective is to characterize the freedom from major complications related to the EV ICD System and/or procedure at 2 weeks post-implant. The endpoint is defined as a subject's first occurrence of a major complication related to the EV ICD System and/or procedure, as determined by an independent Clinical Events Committee (CEC), that occurs on or prior to 2 weeks (14 days) post-implant.||||
72551260|NCT00154102|144632800|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.171||||0.2648|TWO_SIDED|95.0|0.887|1.544|||Stratified log rank|Kaplan-Meier method was used to estimate median PFS time. HR was calculated using Cox proportional hazards model stratified by randomization strata.||The two-sided stratified log-rank test was employed at the 5% significance level, considering the randomization strata (region: Western Europe, Eastern Europe, outside Europe and KPS:\<80 vs. ≥80)||1.544|0.887|0.2648
72583952|NCT07091916|144698710|OTHER|There were no hypotheses for this objective.|Proportion|100.0|||||||||||descriptive statistics|||The primary efficacy objective was to characterize the defibrillation efficacy at implant of the EV ICD System.||||
72583953|NCT03971071|144698792|SUPERIORITY||Common odds ratio|1.37||||0.13|TWO_SIDED|95.0|0.92|2.05|||Cochran-Mantel-Haenszel||Erenumab 70 mg versus Placebo. Common odds ratio and p-value were obtained from a Cochran-Mantel-Haenszel test, stratified by concomitant oral migraine preventive treatment initiated before screening and taken during baseline (Yes or No).|||2.05|0.92|0.13
72583954|NCT03971071|144698792|SUPERIORITY||Common odds ratio|2.01|||<|0.001|TWO_SIDED|95.0|1.33|3.05|||Cochran-Mantel-Haenszel||Erenumab 140 mg versus Placebo. Common odds ratio and p-value were obtained from a Cochran-Mantel-Haenszel test, stratified by concomitant oral migraine preventive treatment initiated before screening and taken during baseline (Yes or No).|||3.05|1.33|<0.001
72551261|NCT00154102|144632801|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.878||||0.0419|TWO_SIDED|95.0|0.774|0.995|||Stratified log rank|Kaplan-Meier method was used to estimate median OS time. HR was calculated using Cox proportional hazards model stratified by randomization strata.||The two-sided stratified log-rank test was employed at the 5% significance level, considering the randomization strata (region: Western Europe, Eastern Europe, outside Europe and KPS:\<80 vs. ≥80)||0.995|0.774|0.0419
72551262|NCT00154102|144632802|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.796||||0.0093|TWO_SIDED|95.0|0.67|0.946|||Stratified log rank|Kaplan-Meier method was used to estimate median OS time. HR was calculated using Cox proportional hazards model stratified by randomization strata.||The two-sided stratified log-rank test was employed at the 5% significance level, considering the randomization strata (region: Western Europe, Eastern Europe, outside Europe and KPS:\<80 vs. ≥80)||0.946|0.670|0.0093
72551263|NCT00154102|144632803|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.035||||0.7549|TWO_SIDED|95.0|0.834|1.284|||Stratified log rank|Kaplan-Meier method was used to estimate median OS time. HR was calculated using Cox proportional hazards model stratified by randomization strata.||The two-sided stratified log-rank test was employed at the 5% significance level, considering the randomization strata (region: Western Europe, Eastern Europe, outside Europe and KPS:\<80 vs. ≥80)||1.284|0.834|0.7549
72551264|NCT00154102|144632804|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.4||||0.0038|TWO_SIDED|95.0|1.12|1.77|||Stratified cochran-mantel haenszel test|||The two-sided stratified Cochran-Mantel-Haenszel (CMH) test was employed at the 5% significance level, considering the randomization strata (region: Western Europe, Eastern Europe, outside Europe and KPS:\<80 vs. ≥80)||1.77|1.12|0.0038
72551265|NCT00154102|144632805|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.069|||<|0.0001|TWO_SIDED|95.0|1.515|2.826|||Cochran-Mantel-Haenszel|||The two-sided stratified Cochran-Mantel-Haenszel (CMH) test was employed at the 5% significance level, considering the randomization strata (region: Western Europe, Eastern Europe, outside Europe and KPS:\<80 vs. ≥80)||2.826|1.515|<0.0001
72551266|NCT00154102|144632806|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.822||||0.3475|TWO_SIDED|95.0|0.544|1.242|||Cochran-Mantel-Haenszel|||The two-sided stratified Cochran-Mantel-Haenszel (CMH) test was employed at the 5% significance level, considering the randomization strata (region: Western Europe, Eastern Europe, outside Europe and KPS:\<80 vs. ≥80)||1.242|0.544|0.3475
72551267|NCT00154102|144632807|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.92||||0.6004|TWO_SIDED|95.0|0.67|1.26|||Stratified cochran-mantel haenszel test|||The two-sided stratified Cochran-Mantel-Haenszel (CMH) test was employed at the 5% significance level, considering the randomization strata (region: Western Europe, Eastern Europe, outside Europe and KPS:\<80 vs. ≥80)||1.26|0.67|0.6004
72551268|NCT00154102|144632809|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.02||||0.002|TWO_SIDED|95.0|1.45|6.27|||Cochran-Mantel-Haenszel|||||6.27|1.45|0.002
72551269|NCT04349917|144632844|SUPERIORITY|||||||0.532|||||||t-test, 2 sided|||||||0.532
72551270|NCT04349917|144632845|SUPERIORITY|||||||0.579|||||||t-test, 2 sided|||Analysis for GNG regular task||||0.579
72551271|NCT04349917|144632845|SUPERIORITY|||||||0.034|||||||t-test, 2 sided|||Analysis for GNG reward task||||0.034
72551272|NCT04349917|144632846|SUPERIORITY|||||||0.296|||||||t-test, 2 sided|||Analysis for reconfiguration between rest and GNG regular task||||0.296
72551273|NCT04349917|144632846|SUPERIORITY|||||||0.169|||||||t-test, 2 sided|||Analysis for reconfiguration between rest and GNG reward task||||0.169
72551274|NCT04349917|144632847|SUPERIORITY|||||||0.118|||||||Pearson correlation|||Change in rest modularity vs change in GNG regular commission rate||||0.118
72551275|NCT04349917|144632847|SUPERIORITY|||||||0.022|||||||Pearson correlation|||Change in rest modularity vs change in GNG regular omission rate||||0.022
72551276|NCT04349917|144632847|SUPERIORITY|||||||0.22|||||||Pearson correlation|||Change in rest modularity vs Change in GNG regular RT Variability||||0.220
72551277|NCT04349917|144632847|SUPERIORITY|||||||0.496|||||||Pearson correlation|||Change in rest modularity vs change in GNG reward commission rate||||0.496
72551278|NCT04349917|144632847|SUPERIORITY|||||||0.343|||||||Pearson correlation|||Change in rest modularity vs change in GNG reward omission rate||||0.343
72551279|NCT04349917|144632847|SUPERIORITY|||||||0.988|||||||Pearson correlation|||Change in rest modularity vs change in GNG reward RT variability||||0.988
72551280|NCT04349917|144632847|SUPERIORITY|||||||0.892|||||||Pearson correlation|||Change in GNG regular modularity vs change in GNG regular commission rate||||0.892
72551281|NCT04349917|144632847|SUPERIORITY|||||||0.473|||||||Pearson correlation|||Change in GNG regular modularity vs change in GNG regular omission rate||||0.473
72551282|NCT04349917|144632847|SUPERIORITY|||||||0.409|||||||Pearson correlation|||Change in GNG regular modularity vs Change in GNG regular RT Variability||||0.409
72551283|NCT04349917|144632847|SUPERIORITY|||||||0.351|||||||Pearson correlation|||Change in GNG reward modularity vs change in GNG reward commission rate||||0.351
72551284|NCT04349917|144632847|SUPERIORITY|||||||0.238|||||||Pearson correlation|||Change in GNG reward modularity vs change in GNG reward omission rate||||0.238
72551285|NCT04349917|144632847|SUPERIORITY|||||||0.909|||||||Pearson correlation|||Change in GNG reward modularity vs Change in GNG reward RT Variability||||0.909
72551286|NCT04349917|144632848|SUPERIORITY|||||||0.806|||||||t-test, 2 sided|||Analysis for GNG regular task||||0.806
72551287|NCT04349917|144632848|SUPERIORITY|||||||0.003|||||||t-test, 2 sided|||Analysis for GNG reward task||||0.003
72551288|NCT04349917|144632849|SUPERIORITY|||||||0.093|||||||t-test, 2 sided|||Analysis for GNG regular task||||0.093
72551289|NCT04349917|144632849|SUPERIORITY|||||||0.0001|||||||t-test, 2 sided|||Analysis for GNG reward task||||0.0001
72551290|NCT04349917|144632850|SUPERIORITY|||||||0.075|||||||t-test, 2 sided|||Analysis for GNG regular task||||0.075
72551291|NCT04349917|144632850|SUPERIORITY|||||||0.0001|||||||t-test, 2 sided|||Analysis for GNG reward task||||0.0001
72551292|NCT01287013|144632939|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
72551293|NCT01287013|144632940|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
72551294|NCT01287013|144632941|OTHER||||||<|0.04|||||||t-test, 2 sided|||||||<0.04
72551295|NCT01287013|144632942|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
72551296|NCT01287013|144632943|SUPERIORITY_OR_OTHER||||||=|0.67|||||||t-test, 2 sided|||||||=0.67
72551297|NCT03203447|144632946|SUPERIORITY||Difference in percentages|-7.1||||0.191|TWO_SIDED|95.0|-17.9|3.6||The a priori threshold for statistical significance was 0.050. Prior to evaluating the results of the CMH test, a Breslow-Day test with Tarone's adjustment was conducted to confirm the homogeneity of the odds ratios between RVO strata.|Cochran-Mantel-Haenszel|The CMH test was stratified by the type of retinal vein occlusion, i.e., branch vs. central.|Estimated value was calculated as the percentage of subjects in the Active arm meeting the primary endpoint minus the percentage of subjects in the Control arm meeting the primary endpoint.|Based on a Pearson chi-square test, a total sample size of approximately 460 subjects provided 90% power to detect a difference of 15% between the Active and Control arms assuming the Control arm showed a proportion of 0.50 at 8 weeks. The primary analysis was a test of superiority of the Active arm over the Control arm, and was based on a Cochran-Mantel-Haenszel chi-square test stratified by type of retinal vein occlusion.||3.6|-17.9|0.191
72551298|NCT00050778|144632998|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.24||||0.0006|TWO_SIDED|95.0|0.11|0.545||An alpha-sharing approach was used to adjust for multiple treatment group comparisons, endpoints, and two pre-planned interim analyses, including a Lan-Demets error-spending function. Pre-specified threshold for statistical significance was 0.0165.|Cox Proportional Hazards Regression|||Cox proportional hazards (PH) regression model using treatment group, Baseline EDSS group (grouped by less than or equal to 1.5 and greater than 1.5), and country (investigative center grouped by country) as covariates was used.||0.545|0.110|0.0006
72551299|NCT00050778|144632998|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.31||||0.0021|TWO_SIDED|95.0|0.151|0.658||An alpha-sharing approach was used to adjust for multiple treatment group comparisons, endpoints, and two pre-planned interim analyses, including a Lan-Demets error-spending function. Pre-specified threshold for statistical significance was 0.0165.|Cox Proportional Hazards Regression|||Cox PH regression model using treatment group, Baseline EDSS group (grouped by less than or equal to 1.5 and greater than 1.5), and country (investigative center grouped by country) as covariates was used.||0.658|0.151|0.0021
72551300|NCT00050778|144632998|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.28|||<|0.0001|TWO_SIDED|95.0|0.152|0.515|||Cox Proportional Hazards Regression|||Cox PH regression model using treatment group, Baseline EDSS group (grouped by less than or equal to 1.5 and greater than 1.5), and country (investigative center grouped by country) as covariates was used.||0.515|0.152|<0.0001
72551301|NCT00050778|144632999|SUPERIORITY_OR_OTHER||Rate ratio|0.33|||<|0.0001|TWO_SIDED|95.0|0.196|0.552||An alpha-sharing approach was used to adjust for multiple treatment group comparisons, endpoints, and two pre-planned interim analyses, including a Lan-Demets error-spending function. Pre-specified threshold for statistical significance was 0.0040.|Andersen-Gill Model|||Treatment effects were estimated using an Anderson-Gill multiplicative intensity model with robust variance estimation. Covariates included treatment group, Baseline EDSS group (grouped by less than or equal to 1.5 and greater than 1.5), and country (investigative center grouped by country).||0.552|0.196|<0.0001
72551302|NCT00050778|144632999|SUPERIORITY_OR_OTHER||Rate ratio|0.23|||<|0.0001|TWO_SIDED|95.0|0.126|0.431||An alpha-sharing approach was used to adjust for multiple treatment group comparisons, endpoints, and two pre-planned interim analyses, including a Lan-Demets error-spending function. Pre-specified threshold for statistical significance was 0.0040.|Andersen-Gill Model|||Treatment effects were estimated using an Anderson-Gill multiplicative intensity model with robust variance estimation. Covariates included treatment group, Baseline EDSS group (grouped by less than or equal to 1.5 and greater than 1.5), and country (investigative center grouped by country).||0.431|0.126|<0.0001
72551303|NCT00050778|144632999|SUPERIORITY_OR_OTHER||Rate ratio|0.28|||<|0.0001|TWO_SIDED|95.0|0.176|0.441|||Andersen-Gill Model|||Treatment effects were estimated using an Anderson-Gill multiplicative intensity model with robust variance estimation. Covariates included treatment group, Baseline EDSS group (grouped by less than or equal to 1.5 and greater than 1.5), and country (investigative center grouped by country).||0.441|0.176|<0.0001
72551304|NCT00050778|144633000|SUPERIORITY_OR_OTHER||Treatment effect|62.64||||0.0001|||||||Cox Proportional Hazards Regression|||Cox PH regression model with treatment group indicator, Baseline EDSS and country as covariates was used.||||0.0001
72551305|NCT00050778|144633000|SUPERIORITY_OR_OTHER||Treatment effect|76.71|||<|0.0001|||||||Cox Proportional Hazards Regression|||Cox PH regression model with treatment group indicator, Baseline EDSS and country as covariates was used.||||<0.0001
72551306|NCT00050778|144633000|SUPERIORITY_OR_OTHER||Treatment effect|70.13|||<|0.0001|||||||Cox Proportional Hazards Regression|||Cox PH regression model with treatment group indicator, Baseline EDSS and country as covariates was used.||||<0.0001
72551307|NCT00050778|144633001|SUPERIORITY_OR_OTHER|||||||0.0885|||||||ANCOVA|||Ranked analysis of covariance (ANCOVA) model using Baseline MRI-T1 brain volume, EDSS group, country, and treatment as covariates was used.||||0.0885
72551308|NCT00050778|144633001|SUPERIORITY_OR_OTHER|||||||0.0195|||||||ANCOVA|||Ranked ANCOVA model using Baseline MRI-T1 brain volume, EDSS group, country, and treatment as covariates was used.||||0.0195
72551309|NCT00050778|144633001|SUPERIORITY_OR_OTHER|||||||0.0215|||||||ANCOVA|||Ranked ANCOVA model using Baseline MRI-T1 brain volume, EDSS group, country, and treatment as covariates was used.||||0.0215
72551310|NCT00050778|144633002|SUPERIORITY_OR_OTHER|||||||0.3077|||||||ANCOVA|||Ranked ANCOVA model using Baseline MRI-T2 lesion volume, EDSS group, country, and treatment as covariates was used.||||0.3077
72551311|NCT00050778|144633002|SUPERIORITY_OR_OTHER|||||||0.3632|||||||ANCOVA|||Ranked ANCOVA model using Baseline MRI-T2 lesion volume, EDSS group, country, and treatment as covariates was used.||||0.3632
72551312|NCT00050778|144633002|SUPERIORITY_OR_OTHER|||||||0.2758|||||||ANCOVA|||Ranked ANCOVA model using Baseline MRI-T2 lesion volume, EDSS group, country, and treatment as covariates was used.||||0.2758
72551313|NCT00064753|144633012|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.99||||0.93|TWO_SIDED|95.0|0.84|1.17||P was calculated with stratified proportional hazards models stratified by country|Regression, Cox|||||1.17|0.84|0.93
72551314|NCT00064753|144633013|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.15||||0.19|TWO_SIDED|95.0|0.93|1.43||P was calculated with stratified proportional hazards models stratified by country|Regression, Cox|||||1.43|0.93|0.19
72551315|NCT00064753|144633014|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.04||||0.67|TWO_SIDED|95.0|0.86|1.26||P was calculated with stratified proportional hazards models stratified by country|Regression, Cox|||||1.26|0.86|0.67
72551316|NCT00064753|144633015|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.08||||0.61|TWO_SIDED|95.0|0.8|1.45||P was calculated with stratified proportional hazards models stratified by country|Regression, Cox|||||1.45|0.80|0.61
72551317|NCT00064753|144633016|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.12||||0.64|TWO_SIDED|95.0|0.69|1.81||P was calculated with stratified proportional hazards models stratified by country|Regression, Cox|||||1.81|0.69|0.64
72551318|NCT00064753|144633017|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.8||||0.66|TWO_SIDED|95.0|0.3|2.15||P was calculated with stratified proportional hazards models stratified by country|Regression, Cox|||||2.15|0.30|0.66
72551319|NCT00064753|144633018|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.84||||0.28|TWO_SIDED|95.0|0.62|1.15|||Regression, Cox|||||1.15|0.62|0.28
72551320|NCT00064753|144633019|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.95||||0.7|TWO_SIDED|95.0|0.73|1.23|||Regression, Cox|P was calculated with stratified proportional hazards models stratified by country||||1.23|0.73|0.70
72551321|NCT00064753|144633020|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.14||||0.49|TWO_SIDED|95.0|0.79|1.65|||Regression, Cox|P was calculated with stratified proportional hazards models stratified by country||||1.65|0.79|0.49
72551322|NCT00064753|144633021|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.14||||0.78|TWO_SIDED|95.0|0.46|2.8|||Regression, Cox|P was calculated with stratified proportional hazards models stratified by country||||2.80|0.46|0.78
72551323|NCT00064753|144633022|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.61||||0.5|TWO_SIDED|95.0|0.15|2.57|||Regression, Cox|P was calculated with stratified proportional hazards models stratified by country||||2.57|0.15|0.50
72551324|NCT00064753|144633023|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.3||||0.6|TWO_SIDED|95.0|0.48|3.5|||Regression, Cox|P was calculated with stratified proportional hazards models stratified by country||||3.50|0.48|0.60
72551325|NCT03834870|144633025|OTHER||Percentage of enrolled from eligible|84.05|||||TWO_SIDED|95.0|81.98|86.1||||||||86.10|81.98|
72551326|NCT03834870|144633026|OTHER||Percentage of enrolled from eligible|99.01|||||TWO_SIDED|95.0|98.4|99.6||||||||99.60|98.40|
72551327|NCT00813293|144633036|SUPERIORITY|||||||0.794|||||||Wilcoxon (Mann-Whitney)|||Assuming the two trial arms were independent, the standard deviation was 0.5cm for both arms and a sample size of 16 evaluable patients (8 per arm), the study had an 84% power at a 5% (two-sided) significance level to detect 0.8cm difference in ablation zone size. In order to allow a 20% drop-out rate, a total of 20 subjects were accrued.||||.794
72551328|NCT00819507|144633044|SUPERIORITY||Mean Difference (Final Values)|6.01|||<|0.01|TWO_SIDED||||||t-test, 2 sided|||||||<0.01
72551329|NCT00819507|144633045|SUPERIORITY||Median Difference (Final Values)|14.35|||<|0.01|TWO_SIDED||||||t-test, 2 sided|||||||<0.01
72551330|NCT00565448|144633069|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED|95.0||||The Fisher's exact test was used to compare the CR proportions.|Fisher Exact|||There was no formal power calculation. A selection design was used to determine how many participants would be accrued to correctly select the treatment group with the best CR rate with 80% probability.||||1.0000
72551331|NCT00302952|144633073|SUPERIORITY_OR_OTHER_LEGACY|||||||0.79||||||Adjustments were made for baseline ln(CRP), baseline DAS28-CRP score, race, methotrexate use, anti-TNF use, and disease duration.|ANCOVA|||The p-value compares Lovastatin with the Placebo treatment group. Log transformed CRP was analyzed to meet the heterogeneity assumption for ANCOVA models.||||0.79
72551332|NCT00302952|144633075|SUPERIORITY_OR_OTHER_LEGACY|||||||0.91||||||Adjustments were made for baseline DAS28-CRP score.|ANCOVA|ANOVA was performed on participants with a DAS28-CRP score at Day 84.||The p-value compares Lovastatin with the Placebo treatment group.||||0.91
72551333|NCT00302952|144633076|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentage|-11.0||||0.39|TWO_SIDED|95.0|-35.9|14.0|||Chi-squared||The difference in percentages is calculated as Lovastatin - Placebo.|The p-value compares Lovastatin with the Placebo treatment group.||14.0|-35.9|0.39
72551334|NCT00302952|144633077|SUPERIORITY_OR_OTHER_LEGACY|||||||0.19||||||Adjustments were made for baseline serum IgM RF by ELISA test result. In the ANCOVA model, baseline value was a covariate; therefore, an adjustment was performed.|ANCOVA|||The p-value compares Lovastatin with the Placebo treatment group.||||0.19
72551335|NCT00302952|144633078|SUPERIORITY_OR_OTHER_LEGACY|||||||0.35||||||Adjustments were made for baseline serum anti-CCP by ELISA|ANCOVA|||The p-value compares Lovastatin with the Placebo treatment group.||||0.35
72551336|NCT02373098|144633088|OTHER|||||||0|||||||Wilcoxon (Mann-Whitney)|||CCL5=RANTES||||0.000
72551337|NCT02373098|144633088|OTHER|||||||0.035|||||||Wilcoxon (Mann-Whitney)|||IL17A||||0.035
72551338|NCT02373098|144633088|OTHER|||||||0.911|||||||Wilcoxon (Mann-Whitney)|||CXCL13||||0.911
72551339|NCT02373098|144633088|OTHER|||||||1|||||||Wilcoxon (Mann-Whitney)|||IL6||||1.000
72551340|NCT02373098|144633088|OTHER|||||||0.934|||||||Wilcoxon (Mann-Whitney)|||IL8||||0.934
72551341|NCT02373098|144633088|OTHER|||||||0.727|||||||Wilcoxon (Mann-Whitney)|||IL13||||0.727
72421538|NCT01181726|144354221|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|95.23|||||TWO_SIDED|90.0|91.17|99.47|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||99.47|91.17|
72551342|NCT02373098|144633088|OTHER|||||||0.179|||||||Wilcoxon (Mann-Whitney)|||IL23||||0.179
72551343|NCT02373098|144633088|OTHER|||||||0.208|||||||Wilcoxon (Mann-Whitney)|||VLA4||||0.208
72551344|NCT02373098|144633088|OTHER|||||||0.73|||||||Wilcoxon (Mann-Whitney)|||CXCL10=IP-10 (CXCR3 ligand)||||0.730
72551345|NCT02373098|144633088|OTHER|||||||0.725|||||||Wilcoxon (Mann-Whitney)|||CCL2=MCP-1||||0.725
72551346|NCT02373098|144633088|OTHER|||||||0.057|||||||Wilcoxon (Mann-Whitney)|||IL4||||0.057
72551347|NCT02373098|144633088|OTHER|||||||0.724|||||||Wilcoxon (Mann-Whitney)|||TNF alpha||||0.724
72551348|NCT02373098|144633088|OTHER|||||||0.662|||||||Wilcoxon (Mann-Whitney)|||IL22||||0.662
72551349|NCT02373098|144633089|OTHER|||||||0.256|||||||Wilcoxon (Mann-Whitney)|||CD3 abs||||0.256
72583955|NCT03971071|144698793|SUPERIORITY||Least squares mean difference|-1.23||||0.033|TWO_SIDED|95.0|-2.35|-0.1||Nominal p-value is presented without multiplicity adjustment.|Linear Mixed Model||Erenumab 70 mg versus Placebo. Covariates: treatment, visit, treatment-by-visit, concomitant oral migraine preventive treatment initiated before screening and taken during baseline (Yes or No), and baseline value.|||-0.10|-2.35|0.033
72583956|NCT03971071|144698793|SUPERIORITY||Least squares mean difference|-2.74|||<|0.001|TWO_SIDED|95.0|-3.87|-1.62||Nominal p-value is presented without multiplicity adjustment.|Linear Mixed Model||Erenumab 140 mg versus Placebo. Covariates: treatment, visit, treatment-by-visit, concomitant oral migraine preventive treatment initiated before screening and taken during baseline (Yes or No), and baseline value.|||-1.62|-3.87|<0.001
72583957|NCT03971071|144698794|SUPERIORITY||Common odds ratio|1.62||||0.019|TWO_SIDED|95.0|1.08|2.43|||Cochran-Mantel-Haenszel||Erenumab 70 mg versus Placebo. Common odds ratio and p-value were obtained from a Cochran-Mantel-Haenszel test, stratified by concomitant oral migraine preventive treatment initiated before screening and taken during baseline (Yes or No).|||2.43|1.08|0.019
72583958|NCT03971071|144698794|SUPERIORITY||Common odds ratio|2.63|||<|0.001|TWO_SIDED|95.0|1.75|3.96|||Cochran-Mantel-Haenszel||Erenumab 140 mg versus Placebo. Common odds ratio and p-value were obtained from a Cochran-Mantel-Haenszel test, stratified by concomitant oral migraine preventive treatment initiated before screening and taken during baseline (Yes or No).|||3.96|1.75|<0.001
72583959|NCT03971071|144698795|SUPERIORITY||Least squares mean difference|-3.25||||0.007|TWO_SIDED|95.0|-5.62|-0.88||Nominal p-value is presented without multiplicity adjustment.|Linear Mixed Model||Erenumab 70 mg versus Placebo. Covariates: treatment, visit, treatment-by-visit, concomitant oral migraine preventive treatment initiated before screening and taken during baseline (Yes or No), and baseline value.|||-0.88|-5.62|0.007
72583960|NCT03971071|144698795|SUPERIORITY||Least squares mean difference|-2.13||||0.075|TWO_SIDED|95.0|-4.48|0.22||Nominal p-value is presented without multiplicity adjustment.|Linear Mixed Model||Erenumab 140 mg versus Placebo. Covariates: treatment, visit, treatment-by-visit, concomitant oral migraine preventive treatment initiated before screening and taken during baseline (Yes or No), and baseline value.|||0.22|-4.48|0.075
72583961|NCT03971071|144698796|SUPERIORITY||Least squares mean difference|-2.61||||0.028|TWO_SIDED|95.0|-4.92|-0.29||Nominal p-value is presented without multiplicity adjustment.|Linear Mixed Model||Erenumab 70 mg versus Placebo. Covariates: treatment, visit, treatment-by-visit, concomitant oral migraine preventive treatment initiated before screening and taken during baseline (Yes or No), and baseline value.|||-0.29|-4.92|0.028
72583962|NCT03971071|144698796|SUPERIORITY||Least squares mean difference|-2.37||||0.043|TWO_SIDED|95.0|-4.67|-0.07||Nominal p-value is presented without multiplicity adjustment.|Linear Mixed Model||Erenumab 140 mg versus Placebo. Covariates: treatment, visit, treatment-by-visit, concomitant oral migraine preventive treatment initiated before screening and taken during baseline (Yes or No), and baseline value.|||-0.07|-4.67|0.043
72551350|NCT02373098|144633089|OTHER|||||||0.587|||||||Wilcoxon (Mann-Whitney)|||CD19 abs||||0.587
72551351|NCT02373098|144633089|OTHER|||||||0.3|||||||Wilcoxon (Mann-Whitney)|||NK abs||||0.300
72551352|NCT02373098|144633089|OTHER|||||||0.096|||||||Wilcoxon (Mann-Whitney)|||NKT abs||||0.096
72551353|NCT02373098|144633089|OTHER|||||||0.27|||||||Wilcoxon (Mann-Whitney)|||Hi CD16CD56 abs||||0.270
72551354|NCT02373098|144633089|OTHER|||||||0.902|||||||Wilcoxon (Mann-Whitney)|||CD4CD25||||0.902
72551355|NCT02373098|144633089|OTHER|||||||0.283|||||||Wilcoxon (Mann-Whitney)|||Hi CD4CD25||||0.283
72551356|NCT02373098|144633092|OTHER|||||||0.017|||||||Wilcoxon (Mann-Whitney)|||CD3 %||||0.017
72551357|NCT02373098|144633092|OTHER|||||||0.3|||||||Wilcoxon (Mann-Whitney)|||CD19 %||||0.300
72551358|NCT02373098|144633092|OTHER|||||||0.657|||||||Wilcoxon (Mann-Whitney)|||NK %||||0.657
72551359|NCT02373098|144633092|OTHER|||||||0.439|||||||Wilcoxon (Mann-Whitney)|||NKT %||||0.439
72551360|NCT02373098|144633092|OTHER|||||||0.449|||||||Wilcoxon (Mann-Whitney)|||Hi CD16CD56 %||||0.449
72551361|NCT02373098|144633092|OTHER|||||||0.356|||||||Wilcoxon (Mann-Whitney)|||CD3CD4||||0.356
72551362|NCT02373098|144633092|OTHER|||||||0.787|||||||Wilcoxon (Mann-Whitney)|||CD3CD8||||0.787
72551363|NCT02373098|144633092|OTHER|||||||0.121|||||||Wilcoxon (Mann-Whitney)|||CD3CD4||||0.121
72551364|NCT02373098|144633092|OTHER|||||||0.209|||||||Wilcoxon (Mann-Whitney)|||CD3CD8||||0.209
72551365|NCT02373098|144633092|OTHER|||||||0.069|||||||Wilcoxon (Mann-Whitney)|||CD4+IFNg+ (in CD4+)||||0.069
72551366|NCT02373098|144633092|OTHER|||||||0.402|||||||Wilcoxon (Mann-Whitney)|||CD4+IL17+ (in CD4+)||||0.402
72551367|NCT02373098|144633092|OTHER|||||||0.017|||||||Wilcoxon (Mann-Whitney)|||CD8+IFNg+ (in CD8+)||||0.017
72551368|NCT02373098|144633092|OTHER|||||||0.017|||||||Wilcoxon (Mann-Whitney)|||CD8+IL17+ (in CD8+)||||0.017
72551369|NCT02373098|144633092|OTHER|||||||0.026|||||||Wilcoxon (Mann-Whitney)|||IFNg+ (in CD4+CD25+)||||0.026
72583963|NCT04537078|144698798|OTHER||Median Difference (Final Values)|1.5||||0.254|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.254
72583964|NCT04537078|144698799|OTHER||Median Difference (Final Values)|9.48||||0.219|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.219
72583965|NCT04537078|144698800|OTHER||Median Difference (Final Values)|1.0||||0.269|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.269
72551370|NCT02373098|144633092|OTHER|||||||0.168|||||||Wilcoxon (Mann-Whitney)|||IL17+ (in CD4+CD25+)||||0.168
72551371|NCT02373098|144633092|OTHER|||||||0.004|||||||Wilcoxon (Mann-Whitney)|||CD4+IL10+ (in CD4+)||||0.004
72551372|NCT02373098|144633092|OTHER|||||||0.013|||||||Wilcoxon (Mann-Whitney)|||CD4+IL4+ (in CD4+)||||0.013
72551373|NCT02373098|144633092|OTHER|||||||0.171|||||||Wilcoxon (Mann-Whitney)|||CD4-CD8-IL4+ (in CD4-CD8-)||||0.171
72551374|NCT02373098|144633092|OTHER|||||||0.013|||||||Wilcoxon (Mann-Whitney)|||CD8+IL10+ (in CD8+)||||0.013
72551375|NCT02373098|144633092|OTHER|||||||0.013|||||||Wilcoxon (Mann-Whitney)|||CD8+IL4+ (in CD8+)||||0.013
72551376|NCT02373098|144633092|OTHER|||||||0.007|||||||Wilcoxon (Mann-Whitney)|||IL10+ (in CD4+CD25+)||||0.007
72551377|NCT02373098|144633092|OTHER|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||IL4+ (in CD4+CD25+)||||0.001
72551378|NCT02373098|144633092|OTHER|||||||0.002|||||||Wilcoxon (Mann-Whitney)|||CD4+TNFa+ (in CD4+)||||0.002
72551379|NCT02373098|144633092|OTHER|||||||0.107|||||||Wilcoxon (Mann-Whitney)|||CD4+IL9+ (in CD4+)||||0.107
72551380|NCT02373098|144633092|OTHER|||||||0|||||||Wilcoxon (Mann-Whitney)|||CD8+TNFa+ (in CD8+)||||0.000
72551381|NCT02373098|144633092|OTHER|||||||0.022|||||||Wilcoxon (Mann-Whitney)|||CD8+IL9+ (in CD8+)||||0.022
72551382|NCT02373098|144633092|OTHER|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||TNFa+ (in CD4+CD25+)||||0.001
72551383|NCT02373098|144633092|OTHER|||||||0.127|||||||Wilcoxon (Mann-Whitney)|||IL9+ (in CD4+CD25+)||||0.127
72551384|NCT00420238|144633095|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.83||||0.019|TWO_SIDED|95.0|-16.5|-1.51|||ANCOVA||Least squares mean difference = mean difference final value.|Comparison of least squares means. Primary analysis: analysis of covariance (ANCOVA) with treatment as a factor and BASDAI baseline as a covariate.||-1.51|-16.5|0.019
72551385|NCT00420238|144633096|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.92||||0.098|TWO_SIDED|95.0|0.82|10.42|||GEE model||An odds-ratio greater than 1 indicates the odds of response is greater in the etanercept group than in the placebo group.|Week 2: Generalized estimating equations (GEE) model, using a logit link, a binomial distribution and an auto-regressive correlation structure, with treatment groups, visits and their interactions as fixed factors.||10.42|0.82|0.098
72551386|NCT00420238|144633096|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.02||||0.197|TWO_SIDED|95.0|0.69|5.88|||GEE model||An odds-ratio greater than 1 indicates the odds of response is greater in the etanercept group than in the placebo group.|Week 4: Generalized estimating equations (GEE) model, using a logit link, a binomial distribution and an auto-regressive correlation structure, with treatment groups, visits and their interactions as fixed factors.||5.88|0.69|0.197
72551387|NCT00420238|144633096|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.3||||0.087|TWO_SIDED|95.0|0.89|5.95|||GEE model||An odds-ratio greater than 1 indicates the odds of response is greater in the etanercept group than in the placebo group.|Week 8: Generalized estimating equations (GEE) model, using a logit link, a binomial distribution and an auto-regressive correlation structure, with treatment groups, visits and their interactions as fixed factors.||5.95|0.89|0.087
72551388|NCT00420238|144633096|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.83||||0.031|TWO_SIDED|95.0|1.1|7.29|||GEE model||An odds-ratio greater than 1 indicates the odds of response is greater in the etanercept group than in the placebo group.|Week 12: Generalized estimating equations (GEE) model, using a logit link, a binomial distribution and an auto-regressive correlation structure, with treatment groups, visits and their interactions as fixed factors.||7.29|1.10|0.031
72551389|NCT00420238|144633097|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.68||||0.31|TWO_SIDED|95.0|0.62|4.57|||GEE model||An odds ratio greater than 1 indicates the odds of response is greater in the etanercept group than in the placebo group.|Week 2: Generalized estimating equations (GEE) model, using a logit link, a binomial distribution and an auto-regressive correlation structure, with treatment groups, visits, and their interaction as fixed factors.||4.57|0.62|0.310
72551390|NCT00420238|144633097|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.61||||0.309|TWO_SIDED|95.0|0.65|3.99|||GEE model||An odds ratio greater than 1 indicates the odds of response is greater in the etanercept group than in the placebo group.|Week 4: Generalized estimating equations (GEE) model, using a logit link, a binomial distribution and an auto-regressive correlation structure, with treatment groups, visits, and their interaction as fixed factors.||3.99|0.65|0.309
72551391|NCT00420238|144633097|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.61||||0.001|TWO_SIDED|95.0|1.81|11.74|||GEE model||An odds ratio greater than 1 indicates the odds of response is greater in the etanercept group than in the placebo group.|Week 8: Generalized estimating equations (GEE) model, using a logit link, a binomial distribution and an auto-regressive correlation structure, with treatment groups, visits, and their interaction as fixed factors.||11.74|1.81|0.001
72551392|NCT00420238|144633097|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.14||||0.003||95.0|1.65|10.42|||GEE model||An odds ratio greater than 1 indicates the odds of response is greater in the etanercept group than in the placebo group.|Week 12: Generalized estimating equations (GEE) model, using a logit link, a binomial distribution and an auto-regressive correlation structure, with treatment groups, visits, and their interaction as fixed factors.||10.42|1.65|0.003
72551393|NCT00420238|144633099|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.13||||0.259|TWO_SIDED|95.0|0.57|7.94|||GEE model||An odds ratio greater than 1 indicates the odds of response is greater in etanercept group than in placebo group.|Week 2: Generalized estimating equations (GEE) model, using a logit link, a binomial distribution and an auto-regressive correlation structure, with treatment groups, visits, and their interaction as fixed factors.||7.94|0.57|0.259
72551394|NCT00420238|144633099|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.54||||0.44||95.0|0.51|4.64|||GEE model||An odds ratio greater than 1 indicates the odds of response is greater in etanercept group than in placebo group.|Week 4: Generalized estimating equations (GEE) model, using a logit link, a binomial distribution and an auto-regressive correlation structure, with treatment groups, visits, and their interaction as fixed factors.||4.64|0.51|0.440
72551395|NCT00420238|144633099|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.88||||0.046||95.0|1.02|8.16|||GEE model||An odds ratio greater than 1 indicates the odds of response is greater in etanercept group than in placebo group.|Week 8: Generalized estimating equations (GEE) model, using a logit link, a binomial distribution and an auto-regressive correlation structure, with treatment groups, visits, and their interaction as fixed factors.||8.16|1.02|0.046
72551396|NCT00420238|144633099|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.85||||0.014||95.0|1.31|11.32|||GEE model||An odds ratio greater than 1 indicates the odds of response is greater in etanercept group than in placebo group.|Week 12: Generalized estimating equations (GEE) model, using a logit link, a binomial distribution and an auto-regressive correlation structure, with treatment groups, visits, and their interaction as fixed factors.||11.32|1.31|0.014
72551397|NCT00420238|144633101|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.01||||0.204|TWO_SIDED|95.0|0.55|16.53|||GEE model||An odds ratio greater than 1 indicates the odds of response is greater in etanercept group than in placebo group.|Week 2: Generalized estimating equations (GEE) model, using a logit link, a binomial distribution and an auto-regressive correlation structure, with treatment groups, visits, and their interaction as fixed factors.||16.53|0.55|0.204
72551398|NCT00420238|144633101|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.48||||0.073||95.0|0.87|23.07|||GEE model||An odds ratio greater than 1 indicates the odds of response is greater in etanercept group than in placebo group.|Week 4: Generalized estimating equations (GEE) model, using a logit link, a binomial distribution and an auto-regressive correlation structure, with treatment groups, visits, and their interaction as fixed factors.||23.07|0.87|0.073
72551399|NCT00420238|144633101|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.73||||0.121||95.0|0.71|19.69|||GEE model||An odds ratio greater than 1 indicates the odds of response is greater in etanercept group than in placebo group.|Week 8: Generalized estimating equations (GEE) model, using a logit link, a binomial distribution and an auto-regressive correlation structure, with treatment groups, visits, and their interaction as fixed factors.||19.69|0.71|0.121
72551400|NCT00420238|144633101|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.36||||0.058||95.0|0.96|11.8|||GEE model||An odds ratio greater than 1 indicates the odds of response is greater in etanercept group than in placebo group.|Week 12: Generalized estimating equations (GEE) model, using a logit link, a binomial distribution and an auto-regressive correlation structure, with treatment groups, visits, and their interaction as fixed factors.||11.80|0.96|0.058
72551401|NCT00420238|144633103|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.5||||0.287|TWO_SIDED|95.0|0.35|35.14|||GEE model||An odds ratio greater than 1 indicates the odds of response is greater in etanercept group than in placebo group.|Week 2: Generalized estimating equations (GEE) model, using a logit link, a binomial distribution and an auto-regressive correlation structure, with treatment groups, visits, and their interaction as fixed factors.||35.14|0.35|0.287
72551402|NCT00420238|144633103|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.8||||0.169||95.0|0.51|44.94|||GEE model||An odds ratio greater than 1 indicates the odds of response is greater in etanercept group than in placebo group.|Week 4: Generalized estimating equations (GEE) model, using a logit link, a binomial distribution and an auto-regressive correlation structure, with treatment groups, visits, and their interaction as fixed factors.||44.94|0.51|0.169
72551403|NCT00420238|144633103|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.48||||0.073||95.0|0.87|23.07|||GEE model||An odds ratio greater than 1 indicates the odds of response is greater in etanercept group than in placebo group.|Week 8: Generalized estimating equations (GEE) model, using a logit link, a binomial distribution and an auto-regressive correlation structure, with treatment groups, visits, and their interaction as fixed factors.||23.07|0.87|0.073
72551404|NCT00420238|144633103|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.48||||0.073||95.0|0.87|23.07|||GEE model||An odds ratio greater than 1 indicates the odds of response is greater in etanercept group than in placebo group.|Week 12: Generalized estimating equations (GEE) model, using a logit link, a binomial distribution and an auto-regressive correlation structure, with treatment groups, visits, and their interaction as fixed factors.||23.07|0.87|0.073
72551405|NCT00420238|144633105|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.95||||0.018|TWO_SIDED|95.0|-18.19|-1.72|||ANCOVA||Least squares mean difference = mean difference final value.|Analysis of covariance (ANCOVA) with treatment as a factor and baseline value as a covariate.||-1.72|-18.19|0.018
72551406|NCT00420238|144633106|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.54||||0.089|TWO_SIDED|95.0|-18.4|1.33|||ANCOVA||Least squares mean difference = mean difference final value.|Week 2: Comparison of leasts squares means. Mixed-model analysis of covariance (ANCOVA) using an auto-regressive correlation structure with treatment groups, visits and their interaction as fixed factors, baseline value as a covariate, and patients as a random factor.||1.33|-18.40|0.089
72551407|NCT00420238|144633106|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.02||||0.11||95.0|-17.89|1.85|||ANCOVA||Least squares mean difference = mean difference final value.|Week 4: Comparison of leasts squares means. Mixed-model analysis of covariance (ANCOVA) using an auto-regressive correlation structure with treatment groups, visits and their interactions as fixed factors, baseline value as a covariate, and patients as a random factor.||1.85|-17.89|0.110
72421539|NCT01181726|144354222|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|97.92|||||TWO_SIDED|90.0|93.44|102.61|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||102.61|93.44|
72583966|NCT04537078|144698801|OTHER||Median Difference (Final Values)|0.0||||0.072|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.072
72583967|NCT04537078|144698802|OTHER|||||||1|||||||Fisher Exact|||||||1
72583968|NCT04537078|144698803|OTHER|||||||0.72|||||||Chi-squared|||||||0.720
72583969|NCT04537078|144698804|OTHER||Median Difference (Final Values)|2.0||||0.002|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.002
72583970|NCT04537078|144698805|OTHER||Median Difference (Final Values)|600.0||||0.007|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.007
72583971|NCT04537078|144698806|OTHER||Median Difference (Final Values)|2.0||||0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.001
72583972|NCT04537078|144698807|OTHER||Median Difference (Final Values)|33.33||||0.04|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.04
72583973|NCT04537078|144698808|OTHER||Median Difference (Final Values)|2.0|||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<0.001
72583974|NCT04537078|144698809|OTHER||Median Difference (Final Values)|0.0||||0.851|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.851
72583975|NCT04537078|144698810|OTHER||Median Difference (Final Values)|25.0||||0.304|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.304
72583976|NCT04537078|144698811|OTHER||Median Difference (Final Values)|1.0||||0.486|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.486
72583977|NCT01568892|144698815|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.16|||<|0.001|TWO_SIDED|95.0|-1.52|-0.8|||ANCOVA||The estimated value represents the adjusted mean difference between the two treatment arms.|||-0.80|-1.52|<0.001
72583978|NCT01697748|144698861|SUPERIORITY|With an SSI rate of 15% at Tampa General Hospital at the time of study design, a sample size of 600 patients was determined to provide a power of 80% to detect a 50% absolute reduction (15 vs. 7.5%) surgical site infection at a two sided alpha = 0.05. Assuming an approximate 10% dropout loss to follow up rate, the total sample size was adjusted to 660.|Odds Ratio (OR)|0.96|||||TWO_SIDED|95.0|0.44|1.96||Variables with at least a borderline association with a treatment arm (P≤ .10) were included in a multiple logistic regression model to verify which is independently associated with the outcome of interest||No P values were reported for the association between dressing type and infection, only relative risk and 95% confidence intervals were reported.||With an SSI rate of 15% at Tampa General Hospital at the time of study design, a sample size of 600 patients was determined to provide a power of 80% to detect a 50% absolute reduction (15 vs. 7.5%) surgical site infection at a two sided alpha = 0.05. Assuming an approximate 10% dropout loss to follow up rate, the total sample size was adjusted to 660.|Besides the Chi Square, Fisher's Exact test, Student T-test, Mann Whitney U test, and logistic regression were utilized where appropriate|1.96|0.44|
72583979|NCT01697748|144698861|SUPERIORITY|With an SSI rate of 15% at Tampa General Hospital at the time of study design, a sample size of 600 patients was determined to provide a power of 80% to detect a 50% absolute reduction (15% vs. 7.5%) surgical site infection at a two side alpha = 0.05. Assuming an approximate 10% dropout loss to follow up rate, the total sample size was adjusted to 660.|||||<|0.05|TWO_SIDED|95.0||||Variables with at least a borderline association (P≤.10) were then included in a multiple logistic regression model to verify which is independently associated with the outcome of interest|Mixed Models Analysis|In addition to the Chi-Square, Fisher's exact test, Student T-Test, Mann Whitney U test and logistic regression were utilized when appropriate.||||||<0.05
72583980|NCT01697748|144698862|SUPERIORITY||||||<|0.05|||||||see below|Chi square, Fisher Exact, Student t-test, Wilcoxon-Mann-Whitney test where appropriate|||In addition to Chi-Square, Fisher's Exact test, Student T-test, Wilcoxon-Mann Whitney test were utilized where appropriate|||<.05
72583981|NCT01697748|144698863|SUPERIORITY||||||<|0.05|TWO_SIDED|95.0|||||Mixed Models Analysis|Chi Square, Fisher's Exact, Student's T test, Wilcoxon-Mann-Whitney test and logistic regression when appropriate,|||Besides the Chi Square, Fisher's Exact test, Student T-test, Wilcoxon-Mann-Whitney Test, and logistic regression were utilized where appropriate|||<.05
72583982|NCT01697748|144698863|SUPERIORITY||||||<|0.05|TWO_SIDED|95.0|||||Mixed Models Analysis|Chi Square, Fisher Exact, Student t-test, Wilcoxon-Mann-Whitney test|||Besides the Chi Square, Fisher's Exact test, Student T-test, Wilcoxon-Mann-Whitney test and logistic regression were utilized where appropriate|||<.05
72583983|NCT01697748|144698865|SUPERIORITY||||||<|0.05|TWO_SIDED|95.0|||||Mixed Models Analysis||||Besides the Chi Square, Fisher's Exact test, Student T-test, Wilcoxon-Mann-Whitney test, and logistic regression were utilized where appropriate|||<0.05
72583984|NCT01697748|144698866|SUPERIORITY||||||<|0.05|TWO_SIDED|95.0|||||Mixed Models Analysis||||In addition to the Chi-square, Fisher's exact test, Student T-Test, Wilcoxon-Mann-Whitney test and logistic regression were utilized where approprate|||<0.05
72583985|NCT01704495|144698875|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.56||||0.119|TWO_SIDED|90.0|0.98|2.49||2-sided p-value|Poisson regression|Correction for overdispersion made by Pearson chi-square|AZD5069 45 mg BID vs Placebo|||2.49|0.98|0.119
72583986|NCT01704495|144698875|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.53||||0.141|TWO_SIDED|90.0|0.95|2.46||2-sided|Poisson Regression|Correction for overdispersion made by Pearson chi-square|AZD5069 15 mg BID vs Placebo|||2.46|0.95|0.141
72583987|NCT01704495|144698875|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.29||||0.397|TWO_SIDED|90.0|0.79|2.11||2-sided|Poisson Regression|Correction for overdispersion made by Pearson chi-square|AZD5069 5 mg BID vs Placebo|||2.11|0.79|0.397
72583988|NCT00997373|144698920|SUPERIORITY_OR_OTHER|||||||0.0373|TWO_SIDED||||||Fisher Exact|||||||0.0373
72583989|NCT03810092|144698987|OTHER||Odds Ratio, log|-0.04||||0.05|TWO_SIDED|95.0|-0.55|0.42|||Regression, Linear|||Relationship between ADL score evolution and hemoglobine rate, in the no transfusion group||0.42|-0.55|0.05
72583990|NCT03810092|144698987|OTHER||Odds Ratio, log|0.39||||0.05|TWO_SIDED|95.0|-1.0|2.2|||Regression, Logistic|||Relationship between ADL score evolution and hemoglobine rate, in the transfusion group||2.2|-1|0.05
72583991|NCT02816736|144698988|SUPERIORITY||ratio of the AUCs|0.95||||0.45|TWO_SIDED|95.0|0.84|1.08|||Regression, Linear|||AUC was normalized for time; With the log-scale, the value of 0 indicates, on average, no change in NTproBNP from baseline.||1.08|0.84|0.45
72421540|NCT01181726|144354223|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|97.77|||||TWO_SIDED|90.0|93.92|101.78|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||101.78|93.92|
72551408|NCT00420238|144633106|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.73||||0.004||95.0|-24.6|-4.86|||ANCOVA||Least squares mean difference = mean difference final value.|Week 8: Comparison of leasts squares means. Mixed-model analysis of covariance (ANCOVA) using an auto-regressive correlation structure with treatment groups, visits and their interactions as fixed factors, baseline value as a covariate, and patients as a random factor.||-4.86|-24.60|0.004
72583992|NCT02816736|144698989|SUPERIORITY||Mean Difference (Net)|-11.22||||0.15|TWO_SIDED|95.0|-26.4|3.97|||general linear model|||||3.97|-26.4|0.15
72583993|NCT02816736|144698990|SUPERIORITY||Odds Ratio (OR)|1.14||||0.51|TWO_SIDED|95.0|0.78|1.68|||ordinal logistic regression|||||1.68|0.78|0.51
72583994|NCT02816736|144698991|SUPERIORITY||Odds Ratio (OR)|1.55||||0.16|TWO_SIDED|95.0|0.84|2.87|||Regression, Logistic|||||2.87|0.84|0.16
72583995|NCT02816736|144698992|SUPERIORITY||Odds Ratio (OR)|0.99||||0.99|TWO_SIDED|95.0|0.34|2.91|||Regression, Logistic|||||2.91|0.34|0.99
72583996|NCT02816736|144698993|SUPERIORITY||Odds Ratio (OR)|2.05||||0.035|TWO_SIDED|95.0|1.05|4.0|||Regression, Logistic|||||4.00|1.05|0.035
72583997|NCT01139775|144699004|SUPERIORITY_OR_OTHER||Bayesian Posterior Probability|0.96|||||TWO_SIDED||||||||Pemetrexed + cisplatin + LY2603618 was considered superior to pemetrexed + cisplatin if the posterior probability of superiority exceeded 0.85.|The analysis for comparing progression-free survival time between the treatment arms used a Bayesian Augmented Control model with a hierarchical random-effects distribution on treatment effects. The final model incorporated historical data from a completed Phase 3 study (NCT00789373) to augment the prospective control arm data.||||
72583998|NCT01139775|144699006|SUPERIORITY_OR_OTHER|||||||0.2294|TWO_SIDED|||||The test of treatment effect was conducted at a 2-sided alpha level of 0.10.|Log Rank|||||||0.2294
72583999|NCT01139775|144699007|SUPERIORITY_OR_OTHER|||||||0.0824|TWO_SIDED|||||The test of treatment effect was conducted at a 2-sided alpha level of 0.10.|Chi-squared|||||||0.0824
72584000|NCT01139775|144699008|SUPERIORITY_OR_OTHER|||||||0.4924|TWO_SIDED|||||The test of treatment effect was conducted at a 2-sided alpha level of 0.10.|Wilcoxon (Mann-Whitney)|||||||0.4924
72584001|NCT01139775|144699019|SUPERIORITY_OR_OTHER|||||||0.0946|TWO_SIDED|||||The test of treatment effect was conducted at a 2-sided alpha level of 0.10.|Chi-squared|||||||0.0946
72584002|NCT01753310|144699022|SUPERIORITY_OR_OTHER||Mean Difference|-8.3|STANDARD_ERROR_OF_MEAN|1.95|<|0.001|TWO_SIDED|95.0|-12.17|-4.47|||t-test, 2 sided|The 2 sided t-test was on weighted overall treatment difference.|Based on the sample size weighted overall treatment difference.|The superiority of Dysport® to placebo was tested at a two-tailed 5% level by using a stratified analysis of covariance (ANCOVA) with baseline TWSTRS total score as covariate and stratified by the randomisation stratification factor (BoNT-A naïve versus BoNT-A non-naïve).||-4.47|-12.17|<0.001
72584003|NCT01753310|144699023|SUPERIORITY_OR_OTHER||Mean Difference|-5.4|STANDARD_ERROR_OF_MEAN|1.65|=|0.001|TWO_SIDED|95.0|-8.67|-2.14|||t-test, 2 sided|The 2 sided t-test was on weighted overall treatment difference.|Based on the sample size weighted overall treatment difference.|The superiority of Dysport® to placebo was tested at a two-tailed 5% level by using a stratified ANCOVA with baseline TWSTRS total score as covariate and stratified by the randomisation stratification factor (BoNT-A naïve versus BoNT-A non-naïve).||-2.14|-8.67|=0.001
72584004|NCT01753310|144699024|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA|||The superiority of Dysport® to placebo on CGIC of CD was tested at a two-tailed 5% level by using an analysis of variance (ANOVA) with treatment and randomisation stratification factor as main effects.||||<0.001
72584005|NCT01753310|144699025|SUPERIORITY_OR_OTHER||||||=|0.033|||||||Mantel-Haenszel chi-squared test|||The superiorty of Dysport® to placebo on treatment response was tested at a two-tailed 5% level by using a Mantel-Haenszel chi-squared test stratified by the randomisation factor.||||=0.033
72584006|NCT01753310|144699026|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA|||The superiority of Dysport® to placebo on CGIC of CD was tested at a two-tailed 5% level by using an ANOVA with treatment and randomisation stratification factor as main effects.||||<0.001
72584007|NCT01753310|144699027|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Mantel-Haenszel chi-squared test|||The superiorty of Dysport® to placebo on treatment response was tested at a two-tailed 5% level by using a Mantel-Haenszel chi-squared test stratified by the randomisation factor.||||<0.001
72584008|NCT01753310|144699028|SUPERIORITY_OR_OTHER||||||=|0.174|||||||ANOVA|||The superiority of Dysport® to placebo on CDIP-58 was tested at a two-tailed 5% level by using an ANOVA with treatment and randomisation stratification factor as main effects.||||=0.174
72584009|NCT01753310|144699029|SUPERIORITY_OR_OTHER||||||=|0.583|||||||ANOVA|||The superiority of Dysport® to placebo on CDIP-58 was tested at a two-tailed 5% level by using an ANOVA with treatment and randomisation stratification factor as main effects.||||=0.583
72551409|NCT00420238|144633106|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.27||||0.065||95.0|-19.14|0.59|||ANCOVA||Least squares mean difference = mean difference final value.|Week 12: Comparison of leasts squares means. Mixed-model analysis of covariance (ANCOVA) using an auto-regressive correlation structure with treatment groups, visits and their interactions as fixed factors, baseline value as a covariate, and patients as a random factor.||0.59|-19.14|0.065
72551410|NCT00420238|144633108|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.99||||0.002|TWO_SIDED|95.0|-17.7|-4.28|||ANCOVA||Least squares mean difference = mean difference final value.|Analysis of covariance (ANCOVA) with treatment as a factor and baseline value as a covariate.||-4.28|-17.70|0.002
72551411|NCT00420238|144633109|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.33||||0.054|TWO_SIDED|95.0|-16.81|0.15|||ANCOVA||Least squares mean difference = mean difference final value.|Week 2: Comparison of leasts squares means. Mixed-model analysis of covariance (ANCOVA) using an auto-regressive correlation structure with treatment groups, visits and their interaction as fixed factors, baseline value as a covariate, and patients as a random factor.||0.15|-16.81|0.054
72584010|NCT00450437|144699068|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the hSBA GMT at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 1 and Investigational vaccine MenACWY Lot 2 would be equivalent for Neisseria Meningitidis strain A with respect to the immune response to the vaccine lot.|hSBA GMT ratios|0.89|||||TWO_SIDED|95.0|0.68|1.16|||ANOVA|||The study would be considered a success if the two-sided 95% confidence intervals (CIs) for the hSBA GMT ratios comparing Investigational vaccine MenACWY Lot 1 to Investigational vaccine MenACWY Lot 2 for Neisseria Meningitidis strain A at 1 month after vaccination was contained within the equivalence interval (0.5, 2.0).||1.16|0.68|
72584011|NCT00450437|144699068|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the hSBA GMT at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 1 and Investigational vaccine MenACWY Lot 3 would be equivalent for Neisseria Meningitidis strain A with respect to the immune response to the vaccine lot.|hSBA GMT ratios|0.95|||||TWO_SIDED|95.0|0.73|1.23|||ANOVA|||The study would be considered a success if the two-sided 95% confidence intervals (CIs) for the hSBA GMT ratios comparing Investigational vaccine MenACWY Lot 1 to Investigational vaccine MenACWY Lot 3 for Neisseria Meningitidis strain A at 1 month after vaccination was contained within the equivalence interval (0.5, 2.0).||1.23|0.73|
72584012|NCT00450437|144699068|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the hSBA GMT at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 2 and Investigational vaccine MenACWY Lot 3 would be equivalent for Neisseria Meningitidis strain A with respect to the immune response to the vaccine lot.|hSBA GMT ratios|1.06|||||TWO_SIDED|95.0|0.81|1.38|||ANOVA|||The study would be considered a success if the two-sided 95% confidence intervals (CIs) for the hSBA GMT ratios comparing Investigational vaccine MenACWY Lot 2 to Investigational vaccine MenACWY Lot 3 for Neisseria Meningitidis strain A at 1 month after vaccination was contained within the equivalence interval (0.5, 2.0).||1.38|0.81|
72584013|NCT00450437|144699068|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the hSBA GMT at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 1 and Investigational vaccine MenACWY Lot 3 would be equivalent for Neisseria Meningitidis strain C with respect to the immune response to the vaccine lot.|hSBA GMT ratios|1.2|||||TWO_SIDED|95.0|0.9|1.6|||ANOVA|||The study would be considered a success if the two-sided 95% confidence intervals (CIs) for the hSBA GMT ratios comparing Investigational vaccine MenACWY Lot 1 to Investigational vaccine MenACWY Lot 3 for Neisseria Meningitidis strain C at 1 month after vaccination was contained within the equivalence interval (0.5, 2.0).||1.6|0.9|
72584014|NCT00450437|144699068|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the hSBA GMT at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 1 and Investigational vaccine MenACWY Lot 2 would be equivalent for Neisseria Meningitidis strain C with respect to the immune response to the vaccine lot.|hSBA GMT ratios|1.33|||||TWO_SIDED|95.0|1.0|1.77|||ANOVA|||The study would be considered a success if the two-sided 95% confidence intervals (CIs) for the hSBA GMT ratios comparing Investigational vaccine MenACWY Lot 1 to Investigational vaccine MenACWY Lot 2 for Neisseria Meningitidis strain C at 1 month after vaccination was contained within the equivalence interval (0.5, 2.0).||1.77|1|
72584015|NCT00450437|144699068|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the hSBA GMT at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 2 and Investigational vaccine MenACWY Lot 3 would be equivalent for Neisseria Meningitidis strain C with respect to the immune response to the vaccine lot.|hSBA GMT ratios|0.9|||||TWO_SIDED|95.0|0.68|1.2|||ANOVA|||The study would be considered a success if the two-sided 95% confidence intervals (CIs) for the hSBA GMT ratios comparing Investigational vaccine MenACWY Lot 2 to Investigational vaccine MenACWY Lot 3 for Neisseria Meningitidis strain C at 1 month after vaccination was contained within the equivalence interval (0.5, 2.0).||1.2|0.68|
72584016|NCT00450437|144699068|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the hSBA GMT at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 1 and Investigational vaccine MenACWY Lot 2 would be equivalent for Neisseria Meningitidis strain W with respect to the immune response to the vaccine lot.|hSBA GMT ratios|0.79|||||TWO_SIDED|95.0|0.63|0.97|||ANOVA|||The study would be considered a success if the two-sided 95% confidence intervals (CIs) for the hSBA GMT ratios comparing Investigational vaccine MenACWY Lot 1 to Investigational vaccine MenACWY Lot 2 for Neisseria Meningitidis strain W at 1 month after vaccination was contained within the equivalence interval (0.5, 2.0).||0.97|0.63|
72551412|NCT00420238|144633109|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.02||||0.011||95.0|-19.5|-2.54|||ANCOVA||Least squares mean difference = mean difference final value.|Week 4: Comparison of leasts squares means. Mixed-model analysis of covariance (ANCOVA) using an auto-regressive correlation structure with treatment groups, visits and their interaction as fixed factors, baseline value as a covariate, and patients as a random factor.||-2.54|-19.50|0.011
72551413|NCT00420238|144633109|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.75||||0.003||95.0|-21.23|-4.27|||ANCOVA||Least squares mean difference = mean difference final value.|Week 8: Comparison of leasts squares means. Mixed-model analysis of covariance (ANCOVA) using an auto-regressive correlation structure with treatment groups, visits and their interaction as fixed factors, baseline value as a covariate, and patients as a random factor.||-4.27|-21.23|0.003
72551414|NCT00420238|144633109|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.29|||<|0.001||95.0|-23.7|-6.82|||ANCOVA||Least squares mean difference = mean difference final value.|Week 8: Comparison of leasts squares means. Mixed-model analysis of covariance (ANCOVA) using an auto-regressive correlation structure with treatment groups, visits and their interaction as fixed factors, baseline value as a covariate, and patients as a random factor.||-6.82|-23.7|<0.001
72584017|NCT00450437|144699068|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the hSBA GMT at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 1 and Investigational vaccine MenACWY Lot 3 would be equivalent for Neisseria Meningitidis strain W with respect to the immune response to the vaccine lot.|hSBA GMT ratios|1.06|||||TWO_SIDED|95.0|0.86|1.13|||ANOVA|||The study would be considered a success if the two-sided 95% confidence intervals (CIs) for the hSBA GMT ratios comparing Investigational vaccine MenACWY Lot 1 to Investigational vaccine MenACWY Lot 3 for Neisseria Meningitidis strain W at 1 month after vaccination was contained within the equivalence interval (0.5, 2.0).||1.13|0.86|
72584018|NCT00450437|144699068|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the hSBA GMT at one month following vaccination was within this equivalence interval for all pairs of vaccine lots, Investigational vaccine MenACWY Lot 2 and Investigational vaccine MenACWY Lot 3 would be equivalent for Neisseria Meningitidis strain W with respect to the immune response to the vaccine lot.|hSBA GMT ratios|1.35|||||TWO_SIDED|95.0|1.09|1.67|||ANOVA|||The study would be considered a success if the two-sided 95% confidence intervals (CIs) for the hSBA GMT ratios comparing Investigational vaccine MenACWY Lot 2 to Investigational vaccine MenACWY Lot 3 for Neisseria Meningitidis strain W at 1 month after vaccination was contained within the equivalence interval (0.5, 2.0).||1.67|1.09|
72584019|NCT00450437|144699068|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the hSBA GMT at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 1 and Investigational vaccine MenACWY Lot 2 would be equivalent for Neisseria Meningitidis strain Y with respect to the immune response to the vaccine lot.|hSBA GMT ratios|0.79|||||TWO_SIDED|95.0|0.61|1.02|||ANOVA|||The study would be considered a success if the two-sided 95% confidence intervals (CIs) for the hSBA GMT ratios comparing Investigational vaccine MenACWY Lot 1 to Investigational vaccine MenACWY Lot 2 for Neisseria Meningitidis strain Y at 1 month after vaccination was contained within the equivalence interval (0.5, 2.0).||1.02|0.61|
72584020|NCT00450437|144699068|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the hSBA GMT at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 1 and Investigational vaccine MenACWY Lot 3 would be equivalent for Neisseria Meningitidis strain Y with respect to the immune response to the vaccine lot.|hSBA GMT ratios|0.91|||||TWO_SIDED|95.0|0.7|1.18|||ANOVA|||The study would be considered a success if the two-sided 95% confidence intervals (CIs) for the hSBA GMT ratios comparing Investigational vaccine MenACWY Lot 1 to Investigational vaccine MenACWY Lot 3 for Neisseria Meningitidis strain Y at 1 month after vaccination was contained within the equivalence interval (0.5, 2.0).||1.18|0.7|
72584021|NCT00450437|144699068|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the hSBA GMT at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 2 and Investigational vaccine MenACWY Lot 3 would be equivalent for Neisseria Meningitidis strain Y with respect to the immune response to the vaccine lot.|hSBA GMT ratios|1.16|||||TWO_SIDED|95.0|0.89|1.5|||ANOVA|||The study would be considered a success if the two-sided 95% confidence intervals (CIs) for the hSBA GMT ratios comparing Investigational vaccine MenACWY Lot 2 to Investigational vaccine MenACWY Lot 3 for Neisseria Meningitidis strain Y at 1 month after vaccination was contained within the equivalence interval (0.5, 2.0).||1.5|0.89|
72584022|NCT00450437|144699069|NON_INFERIORITY_OR_EQUIVALENCE|Immunogenicity of the Investigational MenACWY vaccine would be considered non-inferior to that of the Licensed MenACWY vaccine if the lower limit of the two-sided CI for the between group difference (investigational vaccine minus licensed vaccine) in percentage of seroresponders one month after vaccination is \> -10%.|Vaccine group difference|8.0|||||TWO_SIDED|95.0|3.0|14.0|||ANOVA|||Vaccine group difference Investigational MenACWY vaccine vs. Licensed MenaCWY vaccine, MenA.||14|3|
72584023|NCT00450437|144699069|NON_INFERIORITY_OR_EQUIVALENCE|Immunogenicity of the Investigational MenACWY vaccine would be considered non-inferior to that of the Licensed MenACWY vaccine if the lower limit of the two-sided CI for the between group difference (investigational vaccine minus licensed vaccine) in percentage of seroresponders one month after vaccination is \> -10%.|Vaccine group difference|2.0|||||TWO_SIDED|95.0|-2.0|7.0|||ANOVA|||Vaccine group difference Investigational MenACWY vaccine vs. Licensed MenaCWY vaccine, MenC.||7|-2|
72584024|NCT00450437|144699069|NON_INFERIORITY_OR_EQUIVALENCE|Immunogenicity of the Investigational MenACWY vaccine would be considered non-inferior to that of the Licensed MenACWY vaccine if the lower limit of the two-sided CI for the between group difference (investigational vaccine minus licensed vaccine) in percentage of seroresponders one month after vaccination is \> -10%.|Vaccine group difference|12.0|||||TWO_SIDED|95.0|6.0|18.0|||ANOVA|||Vaccine group difference Investigational MenACWY vaccine vs. Licensed MenaCWY vaccine, MenW.||18|6|
72551415|NCT00420238|144633111|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.59||||0.039|TWO_SIDED|95.0|-18.69|-0.49|||ANCOVA||Least squares mean difference = mean difference final value.|Analysis of covariance (ANCOVA) with treatment as a factor and baseline value as a covariate.||-0.49|-18.69|0.039
72551416|NCT00420238|144633112|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.28||||0.254|TWO_SIDED|95.0|-17.13|4.57|||ANCOVA||Least squares mean difference = mean difference final value.|Week 2: Comparison of leasts squares means. Mixed-model analysis of covariance (ANCOVA) using an auto-regressive correlation structure with treatment groups, visits and their interaction as fixed factors, baseline value as a covariate, and patients as a random factor.||4.57|-17.13|0.254
72551417|NCT00420238|144633112|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.17||||0.348||95.0|-16.02|5.68|||ANCOVA||Least squares mean difference = mean difference final value.|Week 4: Comparison of leasts squares means. Mixed-model analysis of covariance (ANCOVA) using an auto-regressive correlation structure with treatment groups, visits and their interaction as fixed factors, baseline value as a covariate, and patients as a random factor.||5.68|-16.02|0.348
72551418|NCT00420238|144633112|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.72||||0.014||95.0|-24.57|-2.88|||ANCOVA||Least squares mean difference = mean difference final value.|Week 8: Comparison of leasts squares means. Mixed-model analysis of covariance (ANCOVA) using an auto-regressive correlation structure with treatment groups, visits and their interaction as fixed factors, baseline value as a covariate, and patients as a random factor.||-2.88|-24.57|0.014
72551419|NCT00420238|144633112|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.69|||<|0.001||95.0|-30.54|-8.84|||ANCOVA||Least squares mean difference = mean difference final value.|Week 12: Comparison of leasts squares means. Mixed-model analysis of covariance (ANCOVA) using an auto-regressive correlation structure with treatment groups, visits and their interaction as fixed factors, baseline value as a covariate, and patients as a random factor.||-8.84|-30.54|<0.001
72551420|NCT00420238|144633114|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.49||||0.071|TWO_SIDED|95.0|-17.73|0.75|||ANCOVA||Least squares mean difference = mean difference final value.|Analysis of covariance (ANCOVA) with treatment as a factor and baseline value as a covariate.||0.75|-17.73|0.071
72552937|NCT02246166|144636942|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.19||||0.721|TWO_SIDED|95.0|-1.23|0.86|||ANCOVA|From ANCOVA model with factors for treatment group and study site and baseline TSS score as a covariate.|Difference is first named treatment minus the second named treatment such that a negative difference favors the first named treatme|||0.86|-1.23|0.7210
72552938|NCT02246166|144636943|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.21||||0.7445|TWO_SIDED|95.0|-1.07|1.49|||ANCOVA|From ANCOVA model with factors for treatment group and study site and baseline TSS score as a covariate.||||1.49|-1.07|0.7445
72552939|NCT02246166|144636944|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.23||||0.7662|TWO_SIDED|95.0|-1.32|1.78|||ANCOVA|From ANCOVA model with factors for treatment group and study site and baseline TSS score as a covariate||||1.78|-1.32|0.7662
72552940|NCT02246166|144636945|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.56||||0.5208|TWO_SIDED|95.0|-1.18|2.29|||ANCOVA|From ANCOVA model with factors for treatment group and study site and baseline TSS score as a covariate.|Difference is first named treatment minus the second named treatment such that a negative difference favors the first named treatment|||2.29|-1.18|0.5208
72552941|NCT02246166|144636946|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.12||||0.8993|TWO_SIDED|95.0|-1.71|1.94|||ANCOVA|From ANCOVA model with factors for treatment group and study site and baseline TSS score as a covariate.|Difference is first named treatment minus the second named treatment such that a negative difference favors the first named treatment|||1.94|-1.71|0.8993
72552942|NCT00627016|144636956|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical significance for the comparison of the primary endpoint was determined at 0.05 level.|Wilcoxon (Mann-Whitney)|||||||<0.001
72552943|NCT00627016|144636957|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical significance was only declared if the primary endpoint was statistically significant at 0.05 level. The multiplicity between the two secondary endpoints was adjusted by Hommel-Simes method to maintain the overall 0.05 level.|Fisher Exact|||||||<0.001
72552944|NCT00627016|144636958|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical significance was only declared if the primary endpoint was statistically significant at 0.05 level. The multiplicity between the two secondary endpoints was adjusted by Hommel-Simes method to maintain the overall 0.05 level.|Fisher Exact|||||||<0.001
72552945|NCT02678286|144636984|SUPERIORITY|||||||0.0145|||||||t-test, 2 sided|||||||0.0145
72552946|NCT02678286|144636985|SUPERIORITY|||||||0.1841||||||Row 1 (SPID6)|t-test, 2 sided|||||||0.1841
72552947|NCT02678286|144636985|SUPERIORITY|||||||0.0434||||||Row 2 (SPID12)|t-test, 2 sided|||||||0.0434
72552948|NCT02678286|144636985|SUPERIORITY|||||||0.004||||||Row 3 (SPID48)|t-test, 2 sided|||||||0.0040
72552949|NCT02678286|144636985|SUPERIORITY|||||||0.0028||||||Row 4 (SPID24-48)|t-test, 2 sided|||||||0.0028
72552950|NCT02678286|144636986|SUPERIORITY|||||||0.7572|||||||Log Rank|||||||0.7572
72552951|NCT02678286|144636987|SUPERIORITY|||||||0.6559||||||Row 1 (Hour 0-24)|Cochran-Mantel-Haenszel|||||||0.6559
72552952|NCT02678286|144636987|SUPERIORITY|||||||0.0014||||||Row 2 (Hour 24-48)|Cochran-Mantel-Haenszel|||||||0.0014
72552953|NCT02678286|144636987|SUPERIORITY|||||||0.4994||||||Row 3 (Hour 0-48)|Cochran-Mantel-Haenszel|||||||0.4994
72552954|NCT02678286|144636988|SUPERIORITY|||||||0.0275||||||Row 1 (Hour 0-24)|ANCOVA|P-values were derived from ANCOVA models with fixed effects of treatment, baseline PI score, and investigational site||||||0.0275
72552955|NCT02678286|144636988|SUPERIORITY|||||||0.0009||||||Row 2 (Hour 24-48)|ANCOVA|P-values were derived from ANCOVA models with fixed effects of treatment, baseline PI score, and investigational site||||||0.0009
72552956|NCT02678286|144636988|SUPERIORITY|||||||0.0027||||||Row 3 (Hour 0-48)|ANCOVA|P-values were derived from ANCOVA models with fixed effects of treatment, baseline PI score, and investigational site||||||0.0027
72552957|NCT02678286|144636989|SUPERIORITY|||||||0.005|||||||Log Rank|||||||0.0050
72552958|NCT02678286|144636990|SUPERIORITY|||||||0.5096|||||||Log Rank|||||||0.5096
72552959|NCT02678286|144636991|SUPERIORITY|||||||0.389|||||||Cochran-Mantel-Haenszel|||||||0.3890
72552960|NCT02678286|144636992|SUPERIORITY|||||||0.0178|||||||Cochran-Mantel-Haenszel|||||||0.0178
72552961|NCT02678286|144636993|SUPERIORITY|||||||0.1888|||||||Cochran-Mantel-Haenszel|||||||0.1888
72552962|NCT02678286|144636994|SUPERIORITY|||||||0.0788|||||||Cochran-Mantel-Haenszel|||||||0.0788
72552963|NCT02678286|144636995|SUPERIORITY|||||||0.0607|||||||Cochran-Mantel-Haenszel|P-value was derived from comparisons between N1539 and Placebo via General Association of CMH Test controlling for investigational site||||||0.0607
72551421|NCT00420238|144633115|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.57||||0.511|TWO_SIDED|95.0|-14.31|7.17|||ANCOVA||Least squares mean difference = mean difference final value.|Week 2: Comparison of leasts squares means. Mixed-model analysis of covariance (ANCOVA) using an auto-regressive correlation structure with treatment groups, visits and their interaction as fixed factors, baseline value as a covariate, and patients as a random factor.||7.17|-14.31|0.511
72551422|NCT00420238|144633115|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.57||||0.401||95.0|-15.31|6.17|||ANCOVA||Least squares mean difference = mean difference final value.|Week 4: Comparison of leasts squares means. Mixed-model analysis of covariance (ANCOVA) using an auto-regressive correlation structure with treatment groups, visits and their interaction as fixed factors, baseline value as a covariate, and patients as a random factor.||6.17|-15.31|0.401
72584025|NCT00450437|144699069|NON_INFERIORITY_OR_EQUIVALENCE|Immunogenicity of the Investigational MenACWY vaccine would be considered non-inferior to that of the Licensed MenACWY vaccine if the lower limit of the two-sided CI for the between group difference (investigational vaccine minus licensed vaccine) in percentage of seroresponders one month after vaccination is \> -10%.|Vaccine group difference|27.0|||||TWO_SIDED|95.0|20.0|33.0|||ANOVA|||Vaccine group difference Investigational MenACWY vaccine vs. Licensed MenaCWY vaccine, MenY.||33|20|
72584026|NCT00450437|144699070|NON_INFERIORITY_OR_EQUIVALENCE|MenACWY was considered noninferior to Menactra if the upper limit of the two-sided 95% CI of the difference in the percentage of subjects experiencing at least one severe systemic reaction \[MenACWY minus Menactra\] was less than 6%.|Vaccine group difference|1.0|||||TWO_SIDED|95.0|-1.0|2.0|||ANOVA|||Vaccine group difference Investigational MenACWY vaccine vs. Licensed MenaCWY vaccine, safety.||2|-1|
72584027|NCT00450437|144699071|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (-10%, 10%). If the two sided 95% CIs for percentage of subjects with seroresponse at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 1 and Investigational vaccine MenACWY Lot 2 would be equivalent for Neisseria Meningitidis strain A with respect to the immune response to the vaccine lot.|Vaccine group difference|-3.0|||||TWO_SIDED|95.0|-10.0|3.0|||ANOVA|||Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with seroresponse comparing Investigational vaccine MenACWY Lot 1 to Investigational vaccine MenACWY Lot 2 for Neisseria Meningitidis strain A were contained within the equivalence interval (-10%, 10%).||3|-10|
72584028|NCT00450437|144699071|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (-10%, 10%). If the two sided 95% CIs for percentage of subjects with seroresponse at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 1 and Investigational vaccine MenACWY Lot 3 would be equivalent for Neisseria Meningitidis strain A with respect to the immune response to the vaccine lot.|Vaccine group difference|-6.0|||||TWO_SIDED|95.0|-12.0|0.0|||ANOVA|||Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with seroresponse comparing Investigational vaccine MenACWY Lot 1 to Investigational vaccine MenACWY Lot 3 for Neisseria Meningitidis strain A were contained within the equivalence interval (-10%, 10%).||0|-12|
72584029|NCT00450437|144699071|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (-10%, 10%). If the two sided 95% CIs for percentage of subjects with seroresponse at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 2 and Investigational vaccine MenACWY Lot 3 would be equivalent for Neisseria Meningitidis strain A with respect to the immune response to the vaccine lot.|Vaccine group difference|-3.0|||||TWO_SIDED|95.0|-9.0|4.0|||ANOVA|||Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with seroresponse comparing Investigational vaccine MenACWY Lot 2 to Investigational vaccine MenACWY Lot 3 for Neisseria Meningitidis strain A were contained within the equivalence interval (-10%, 10%).||4|-9|
72584030|NCT00450437|144699071|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (-10%, 10%). If the two sided 95% CIs for percentage of subjects with seroresponse at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 1 and Investigational vaccine MenACWY Lot 2 would be equivalent for Neisseria Meningitidis strain C with respect to the immune response to the vaccine lot.|Vaccine group difference|5.0|||||TWO_SIDED|95.0|0.0|10.0|||ANOVA|||Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with seroresponse comparing Investigational vaccine MenACWY Lot 1 to Investigational vaccine MenACWY Lot 2 for Neisseria Meningitidis strain C were contained within the equivalence interval (-10%, 10%).||10|0|
72584031|NCT00450437|144699071|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (-10%, 10%). If the two sided 95% CIs for percentage of subjects with seroresponse at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 1 and Investigational vaccine MenACWY Lot 3 would be equivalent for Neisseria Meningitidis strain C with respect to the immune response to the vaccine lot.|Vaccine group difference|4.0|||||TWO_SIDED|95.0|-1.0|10.0|||ANOVA|||Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with seroresponse comparing Investigational vaccine MenACWY Lot 1 to Investigational vaccine MenACWY Lot 3 for Neisseria Meningitidis strain C were contained within the equivalence interval (-10%, 10%).||10|-1|
72551423|NCT00420238|144633115|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.45||||0.023||95.0|-23.19|-1.71|||ANCOVA||Least squares mean difference = mean difference final value.|Week 8: Comparison of leasts squares means. Mixed-model analysis of covariance (ANCOVA) using an auto-regressive correlation structure with treatment groups, visits and their interaction as fixed factors, baseline value as a covariate, and patients as a random factor.||-1.71|-23.19|0.023
72551424|NCT00420238|144633115|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.25||||0.01||95.0|-24.99|-3.51|||ANCOVA||Least squares mean difference = mean difference final value.|Week 12: Comparison of leasts squares means. Mixed-model analysis of covariance (ANCOVA) using an auto-regressive correlation structure with treatment groups, visits and their interaction as fixed factors, baseline value as a covariate, and patients as a random factor.||-3.51|-24.99|0.010
72551425|NCT00420238|144633117|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.25||||0.127|TWO_SIDED|95.0|-12.03|1.53|||ANCOVA||Least squares mean difference = mean difference final value.|Analysis of covariance (ANCOVA) with treatment as a factor and baseline as a covariate.||1.53|-12.03|0.127
72421541|NCT01181726|144354224|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|99.71|||||TWO_SIDED|90.0|94.42|105.3|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||105.30|94.42|
72551426|NCT00420238|144633118|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.43||||0.914|TWO_SIDED|95.0|-8.23|7.38|||ANCOVA||Least squares mean difference = mean difference final value.|Week 2: Comparison of leasts squares means. Mixed-model analysis of covariance (ANCOVA) using an auto-regressive correlation structure with treatment groups, visits and their interaction as fixed factors, baseline value as a covariate, and patients as a random factor.||7.38|-8.23|0.914
72551427|NCT00420238|144633118|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.4||||0.544||95.0|-10.21|5.41|||ANCOVA||Least squares mean difference = mean difference final value.|Week 4: Comparison of leasts squares means. Mixed-model analysis of covariance (ANCOVA) using an auto-regressive correlation structure with treatment groups, visits and their interaction as fixed factors, baseline value as a covariate, and patients as a random factor.||5.41|-10.21|0.544
72551428|NCT00420238|144633118|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.21||||0.039||95.0|-16.02|-0.4|||ANCOVA||Least squares mean difference = mean difference final value.|Week 8: Comparison of leasts squares means. Mixed-model analysis of covariance (ANCOVA) using an auto-regressive correlation structure with treatment groups, visits and their interaction as fixed factors, baseline value as a covariate, and patients as a random factor.||-0.40|-16.02|0.039
72551429|NCT00420238|144633118|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.54||||0.004||95.0|-19.35|-3.73|||ANCOVA||Least squares mean difference = mean difference final value.|Week 12: Comparison of leasts squares means. Mixed-model analysis of covariance (ANCOVA) using an auto-regressive correlation structure with treatment groups, visits and their interaction as fixed factors, baseline value as a covariate, and patients as a random factor.||-3.73|-19.35|0.004
72551430|NCT00420238|144633121|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.86||||0.122|TWO_SIDED|95.0|-15.57|1.85|||ANCOVA||Least squares mean difference = mean difference final value.|Week 2: Comparison of leasts squares means. Mixed-model analysis of covariance (ANCOVA) using an auto-regressive correlation structure with treatment groups, visits and their interaction as fixed factors, baseline value as a covariate, and patients as a random factor.||1.85|-15.57|0.122
72551431|NCT00420238|144633121|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.45||||0.145||95.0|-15.16|2.26|||ANCOVA||Least squares mean difference = mean difference final value.|Week 4: Comparison of leasts squares means. Mixed-model analysis of covariance (ANCOVA) using an auto-regressive correlation structure with treatment groups, visits and their interaction as fixed factors, baseline value as a covariate, and patients as a random factor.||2.26|-15.16|0.145
72551432|NCT00420238|144633121|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.55||||0.005||95.0|-21.26|-3.84|||ANCOVA||Least squares mean difference = mean difference final value.|Week 8: Comparison of leasts squares means. Mixed-model analysis of covariance (ANCOVA) using an auto-regressive correlation structure with treatment groups, visits and their interaction as fixed factors, baseline value as a covariate, and patients as a random factor.||-3.84|-21.26|0.005
72584032|NCT00450437|144699071|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (-10%, 10%). If the two sided 95% CIs for percentage of subjects with seroresponse at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 2 and Investigational vaccine MenACWY Lot 3 would be equivalent for Neisseria Meningitidis strain C with respect to the immune response to the vaccine lot.|Vaccine group difference|-1.0|||||TWO_SIDED|95.0|-6.0|5.0|||ANOVA|||Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with seroresponse comparing Investigational vaccine MenACWY Lot 2 to Investigational vaccine MenACWY Lot 2 for Neisseria Meningitidis strain C were contained within the equivalence interval (-10%, 10%).||5|-6|
72584033|NCT00450437|144699071|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (-10%, 10%). If the two sided 95% CIs for percentage of subjects with seroresponse at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 1 and Investigational vaccine MenACWY Lot 2 would be equivalent for Neisseria Meningitidis strain W with respect to the immune response to the vaccine lot.|Vaccine group difference|-6.0|||||TWO_SIDED|95.0|-13.0|0.0|||ANOVA|||Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with seroresponse comparing Investigational vaccine MenACWY Lot 1 to Investigational vaccine MenACWY Lot 2 for Neisseria Meningitidis strain W were contained within the equivalence interval (-10%, 10%).||0|-13|
72551433|NCT00420238|144633121|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.95||||0.008||95.0|-20.66|-3.24|||ANCOVA||Least squares mean difference = mean difference final value.|Week 12: Comparison of leasts squares means. Mixed-model analysis of covariance (ANCOVA) using an auto-regressive correlation structure with treatment groups, visits and their interaction as fixed factors, baseline value as a covariate, and patients as a random factor.||-3.24|-20.66|0.008
72551434|NCT00420238|144633125|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.94||||0.139|TWO_SIDED|95.0|-13.84|1.96|||ANCOVA||Least squares mean difference = mean difference final value.|Analysis of covariance (ANCOVA) with treatment as a factor and baseline value as a covariate.||1.96|-13.84|0.139
72551435|NCT00420238|144633126|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.89||||0.857|TWO_SIDED|95.0|-8.88|10.67|||ANCOVA||Least squares mean difference = mean difference final value.|Week 2: Comparison of leasts squares means. Mixed-model analysis of covariance (ANCOVA) using an auto-regressive correlation structure with treatment groups, visits and their interaction as fixed factors, baseline value as a covariate, and patients as a random factor.||10.67|-8.88|0.857
72551436|NCT00420238|144633126|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.1||||0.304||95.0|-14.88|4.67|||ANCOVA||Least squares mean difference = mean difference final value.|Week 4: Comparison of leasts squares means. Mixed-model analysis of covariance (ANCOVA) using an auto-regressive correlation structure with treatment groups, visits and their interaction as fixed factors, baseline value as a covariate, and patients as a random factor.||4.67|-14.88|0.304
72551437|NCT00420238|144633126|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.9||||0.047||95.0|-19.68|-0.13|||ANCOVA||Least squares mean difference = mean difference final value.|Week 8: Comparison of leasts squares means. Mixed-model analysis of covariance (ANCOVA) using an auto-regressive correlation structure with treatment groups, visits and their interaction as fixed factors, baseline value as a covariate, and patients as a random factor.||-0.13|-19.68|0.047
72551438|NCT00420238|144633126|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.65||||0.007||95.0|-23.43|-3.88|||ANCOVA||Least squares mean difference = mean difference final value.|Week 12: Comparison of leasts squares means. Mixed-model analysis of covariance (ANCOVA) using an auto-regressive correlation structure with treatment groups, visits and their interaction as fixed factors, baseline value as a covariate, and patients as a random factor.||-3.88|-23.43|0.007
72551439|NCT00420238|144633129|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.19||||0.003|TWO_SIDED|95.0|0.06|0.31|||ANCOVA||Least squares mean difference = mean difference final value.|Vital Capacity: Analysis of covariance (ANCOVA) with treatment as a factor and baseline value as a covariate.||0.31|0.06|0.003
72551440|NCT00420238|144633129|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.18||||0.006|TWO_SIDED|95.0|0.05|0.31|||ANCOVA||Least squares mean difference = mean difference final value.|Forced Vital Capacity: Analysis of covariance (ANCOVA) with treatment as a factor and baseline value as a covariate.||0.31|0.05|0.006
72551441|NCT00420238|144633129|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.06||||0.205|TWO_SIDED|95.0|-0.04|0.17|||ANCOVA||Least squares mean difference = mean difference final value.|Forced Expitatory Volume in 1 second: Analysis of covariance (ANCOVA) with treatment as a factor and baseline value as a covariate.||0.17|-0.04|0.205
72551442|NCT00420238|144633130|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.59||||0.03|TWO_SIDED|95.0|-4.93|-0.26|||ANCOVA||Least squares mean difference = mean difference final value.|Analysis oaf covariance (ANCOVA) with treatment as a factor and baseline value as a covariate.||-0.26|-4.93|0.030
72551443|NCT00420238|144633131|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.23||||0.035|TWO_SIDED|95.0|-0.45|-0.02|||ANCOVA||Least squares mean difference = mean difference final value.|Analysis of covariance (ANCOVA) with treatment as a factor and baseline value as covariate.||-0.02|-0.45|0.035
72551444|NCT00420238|144633132|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.09||||0.515|TWO_SIDED|95.0|-0.38|0.19|||ANCOVA||Least squares mean difference = mean difference final value.|Week 2: Mixed model analysis of covariance (ANCOVA), using an auto-regressive correlation structure, with treatment groups, visits and their interaction as fixed factors, baseline value as a covariate and patients as a random factor.||0.19|-0.38|0.515
72551445|NCT00420238|144633132|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.14||||0.316||95.0|-0.43|0.14|||ANCOVA||Least squares mean difference = mean difference final value.|Week 4: Mixed model analysis of covariance (ANCOVA), using an auto-regressive correlation structure, with treatment groups, visits and their interaction as fixed factors, baseline value as a covariate and patients as a random factor.||0.14|-0.43|0.316
72551446|NCT00420238|144633132|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.39||||0.008||95.0|-0.67|-0.1|||ANCOVA||Least squares mean difference = mean difference final value.|Week 8: Mixed model analysis of covariance (ANCOVA), using an auto-regressive correlation structure, with treatment groups, visits and their interaction as fixed factors, baseline value as a covariate and patients as a random factor.||-0.10|-0.67|0.008
72551447|NCT00420238|144633132|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.37||||0.011||95.0|-0.65|-0.08|||ANCOVA||Least squares mean difference = mean difference final value.|Week 12: Mixed model analysis of covariance (ANCOVA), using an auto-regressive correlation structure, with treatment groups, visits and their interaction as fixed factors, baseline value as a covariate and patients as a random factor.||-0.08|-0.65|0.011
72551448|NCT00420238|144633144|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.07||||0.613|TWO_SIDED|95.0|-0.22|0.37|||ANCOVA||Least squares mean difference = mean difference final value.|Analysis of covariance (ANCOVA) with treatment as a factor and baseline value as a covariate.||0.37|-0.22|0.613
72551449|NCT00420238|144633145|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.07||||0.744|TWO_SIDED|95.0|-0.34|0.47|||ANCOVA||Least squares mean difference = mean difference final value.|Week 2: mixed model analysis of covariance (ANCOVA), using an auto-regressive correlation structure, with treatment groups, visits, and their interaction as fixed factors, baseline value as a covariate and patients as a random factor.||0.47|-0.34|0.744
72551450|NCT00420238|144633145|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.625||95.0|-0.5|0.3|||ANCOVA||Least squares mean difference = mean difference final value.|Week 4: mixed model analysis of covariance (ANCOVA), using an auto-regressive correlation structure, with treatment groups, visits, and their interaction as fixed factors, baseline value as a covariate and patients as a random factor.||0.30|-0.50|0.625
72552964|NCT02678286|144636996|SUPERIORITY|||||||0.0027|||||||Cochran-Mantel-Haenszel|P-value was derived from comparisons between N1539 and Placebo via General Association of CMH Test controlling for investigational site||||||0.0027
72552965|NCT02331394|144636998|EQUIVALENCE|"The equivalence assumes that the true mean difference between the paired samples is zero. Under this model, all observable differences are explained by random variation.Equality margins are:~Upper Equivalence Margin=1.5 Lower Equivalence Margin=-1.5"|||||<|0.05|||||||t-test, 2 sided|||Comparisons of repeated measures were made using paired sample t test, which compared subjects data at 2 different times: baseline and end of the study. A P value of 0.05 was considered statistically significant||||<0.05
72552966|NCT02331394|144637001|SUPERIORITY|Pared t-test was used to evaluate the significance of the change in scores||||||0.02|||||||t-test, 2 sided|||||||0.02
72552967|NCT02459951|144637015|SUPERIORITY|||||||0.059||||||"refer to cylinder A (.5 diameter)"|Regression, Logistic|||||||.059
72552968|NCT02459951|144637015|SUPERIORITY||geometric mean ratio B|||||0.465|||||||Regression, Logistic|"refer to cylinder B(1 diameter)"||||||0.465
72421542|NCT01181726|144354225|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|99.19|||||TWO_SIDED|90.0|94.71|103.87|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||103.87|94.71|
72551451|NCT00420238|144633145|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2||||0.325||95.0|-0.2|0.6|||ANCOVA||Least squares mean difference = mean difference final value.|Week 8: mixed model analysis of covariance (ANCOVA), using an auto-regressive correlation structure, with treatment groups, visits, and their interaction as fixed factors, baseline value as a covariate and patients as a random factor.||0.60|-0.20|0.325
72551452|NCT00420238|144633145|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.06||||0.76||95.0|-0.34|0.46|||ANCOVA||Least squares mean difference = mean difference final value.|Week 12: mixed model analysis of covariance (ANCOVA), using an auto-regressive correlation structure, with treatment groups, visits, and their interaction as fixed factors, baseline value as a covariate and patients as a random factor.||0.46|-0.34|0.760
72551453|NCT00420238|144633147|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.72||||0.49|TWO_SIDED|95.0|-18.35|8.91|||ANCOVA||Least squares mean difference = mean difference final value.|Week 2: mixed model analysis of covariance (ANCOVA), using an auto-regressive correlation structure, with treatment groups, visits and their interaction as fixed factors, baseline value as a covariate and patients as a random factor.||8.91|-18.35|0.490
72551454|NCT00420238|144633147|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.09||||0.651||95.0|-16.73|10.54|||ANCOVA||Least squares mean difference = mean difference final value.|Week 4: mixed model analysis of covariance (ANCOVA), using an auto-regressive correlation structure, with treatment groups, visits and their interaction as fixed factors, baseline value as a covariate and patients as a random factor.||10.54|-16.73|0.651
72551455|NCT00420238|144633147|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.39||||0.84||95.0|-15.12|12.34|||ANCOVA||Least squares mean difference = mean difference final value.|Week 8: mixed model analysis of covariance (ANCOVA), using an auto-regressive correlation structure, with treatment groups, visits and their interaction as fixed factors, baseline value as a covariate and patients as a random factor.||12.34|-15.12|0.840
72551456|NCT00420238|144633147|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.02||||0.562||95.0|-17.81|9.77|||ANCOVA||Least squares mean difference = mean difference final value.|Week 12: mixed model analysis of covariance (ANCOVA), using an auto-regressive correlation structure, with treatment groups, visits and their interaction as fixed factors, baseline value as a covariate and patients as a random factor.||9.77|-17.81|0.562
72551457|NCT00420238|144633149|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.73|||<|0.0001|TWO_SIDED|95.0|-19.44|-10.03|||ANCOVA||Least squares mean difference = mean difference final value.|Analysis of covariance (ANCOVA)with treatment as a factor and baseline vlue as a covariate.||-10.03|-19.44|<0.0001
72551458|NCT00420238|144633150|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.37|||<|0.0001|TWO_SIDED|95.0|-18.17|-6.58|||ANCOVA||Least squares mean difference = mean difference final value.|Week 2: Mixed model analysis of covariance (ANCOVA), using an auto-regressive correlation structure, with treatment groups, visits and their interaction as fixed factors, baseline value as a covariate and atients as a random factor.||-6.58|-18.17|<0.0001
72551459|NCT00420238|144633150|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.45|||<|0.0001||95.0|-23.25|-11.65|||ANCOVA||Least squares mean difference = mean difference final value.|Week 4: Mixed model analysis of covariance (ANCOVA), using an auto-regressive correlation structure, with treatment groups, visits and their interaction as fixed factors, baseline value as a covariate and patients as a random factor.||-11.65|-23.25|<0.0001
72551460|NCT00420238|144633150|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.95|||<|0.0001||95.0|-22.75|-11.15|||ANCOVA||Least squares mean difference = mean difference final value.|Week 8: Mixed model analysis of covariance (ANCOVA), using an auto-regressive correlation structure, with treatment groups, visits and their interaction as fixed factors, baseline value as a covariate and patients as a random factor.||-11.15|-22.75|<0.0001
72551461|NCT00420238|144633150|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-18.16|||<|0.0001||95.0|-23.96|-12.36|||ANCOVA||Least squares mean difference = mean difference final value.|Week 12: Mixed model analysis of covariance (ANCOVA), using an auto-regressive correlation structure, with treatment groups, visits and their interaction as fixed factors, baseline value as a covariate and patients as a random factor.||-12.36|-23.96|<0.0001
72551462|NCT00420238|144633152|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.24|||<|0.0001|TWO_SIDED|95.0|-18.23|-8.25|||ANCOVA||Least squares mean difference = mean difference final value.|Analysis of covariance (ANCOVA), with treatment as a factor and baseline value as a covariate.||-8.25|-18.23|<0.0001
72551463|NCT00420238|144633153|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.32|||<|0.0001|TWO_SIDED|95.0|-20.55|-8.1|||ANCOVA||Least squares mean difference = mean difference final value.|Week 2: Mixed model analysis of covariance (ANCOVA), using an auto-regressive correlation structure, with treatment groups, visits and their interactions as fixed factors, baseline as a covariate and patients as a random factor.||-8.10|-20.55|<0.0001
72551464|NCT00420238|144633153|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.98|||<|0.0001||95.0|-21.2|-8.76|||ANCOVA||Least squares mean difference = mean difference final value.|Week 4: Mixed model analysis of covariance (ANCOVA), using an auto-regressive correlation structure, with treatment groups, visits and their interactions as fixed factors, baseline as a covariate and patients as a random factor.||-8.76|-21.20|<0.0001
72551465|NCT00420238|144633153|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.19|||<|0.0001||95.0|-21.41|-8.96|||ANCOVA||Least squares mean difference = mean difference final value.|Week 8: Mixed model analysis of covariance (ANCOVA), using an auto-regressive correlation structure, with treatment groups, visits and their interactions as fixed factors, baseline as a covariate and patients as a random factor.||-8.96|-21.41|<0.0001
72551466|NCT00420238|144633153|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.41|||<|0.0001||95.0|-20.63|-8.19|||ANCOVA||Least squares mean difference = mean difference final value.|Week 12: Mixed model analysis of covariance (ANCOVA), using an auto-regressive correlation structure, with treatment groups, visits and their interactions as fixed factors, baseline as a covariate and patients as a random factor.||-8.19|-20.63|<0.0001
72584034|NCT00450437|144699071|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (-10%, 10%). If the two sided 95% CIs for percentage of subjects with seroresponse at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 1 and Investigational vaccine MenACWY Lot 3 would be equivalent for Neisseria Meningitidis strain W with respect to the immune response to the vaccine lot.|Vaccine group difference|4.0|||||TWO_SIDED|95.0|-3.0|11.0|||ANOVA|||Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with seroresponse comparing Investigational vaccine MenACWY Lot 1 to Investigational vaccine MenACWY Lot 3 for Neisseria Meningitidis strain W were contained within the equivalence interval (-10%, 10%).||11|-3|
72584035|NCT00450437|144699071|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (-10%, 10%). If the two sided 95% CIs for percentage of subjects with seroresponse at one month following vaccination was within this equivalence interval for all pairs of vaccine lots, Investigational vaccine MenACWY Lot 2 and Investigational vaccine MenACWY Lot 3 would be equivalent for Neisseria Meningitidis strain W with respect to the immune response to the vaccine lot.|Vaccine group difference|10.0|||||TWO_SIDED|95.0|4.0|17.0|||ANOVA|||Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with seroresponse comparing Investigational vaccine MenACWY Lot 2 to Investigational vaccine MenACWY Lot 3 for Neisseria Meningitidis strain W were contained within the equivalence interval (-10%, 10%).||17|4|
72584036|NCT00450437|144699071|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (-10%, 10%). If the two sided 95% CIs for percentage of subjects with seroresponse at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 1 and Investigational vaccine MenACWY Lot 2 would be equivalent for Neisseria Meningitidis strain Y with respect to the immune response to the vaccine lot.|Vaccine group difference|-6.0|||||TWO_SIDED|95.0|-13.0|1.0|||ANOVA|||Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with seroresponse comparing Investigational vaccine MenACWY Lot 1 to Investigational vaccine MenACWY Lot 2 for Neisseria Meningitidis strain Y were contained within the equivalence interval (-10%, 10%).||1|-13|
72584037|NCT00450437|144699071|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (-10%, 10%). If the two sided 95% CIs for percentage of subjects with seroresponse at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 1 and Investigational vaccine MenACWY Lot 3 would be equivalent for Neisseria Meningitidis strain Y with respect to the immune response to the vaccine lot.|Vaccine group difference|1.0|||||TWO_SIDED|95.0|-6.0|8.0|||ANOVA|||Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with seroresponse comparing Investigational vaccine MenACWY Lot 1 to Investigational vaccine MenACWY Lot 3 for Neisseria Meningitidis strain Y were contained within the equivalence interval (-10%, 10%).||8|-6|
72584038|NCT00450437|144699071|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (-10%, 10%). If the two sided 95% CIs for percentage of subjects with seroresponse at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 2 and Investigational vaccine MenACWY Lot 3 would be equivalent for Neisseria Meningitidis strain Y with respect to the immune response to the vaccine lot.|Vaccine group difference|7.0|||||TWO_SIDED|95.0|0.0|14.0|||ANOVA|||Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with seroresponse comparing Investigational vaccine MenACWY Lot 2 to Investigational vaccine MenACWY Lot 3 for Neisseria Meningitidis strain Y were contained within the equivalence interval (-10%, 10%).||14|0|
72584039|NCT00450437|144699071|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (-10%, 10%). If the two sided 95% CIs for the percentage of subjects with hSBA titer ≥1:8 at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 1 and Investigational vaccine MenACWY Lot 2 would be equivalent for Neisseria Meningitidis strain A with respect to the immune response to the vaccine lot.|Vaccine group difference|-3.0|||||TWO_SIDED|95.0|-10.0|3.0|||ANOVA|||Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with hSBA titer ≥1:8 comparing Investigational vaccine MenACWY Lot 1 to Investigational vaccine MenACWY Lot 2 for Neisseria Meningitidis strain A were contained within the equivalence interval (-10%, 10%).||3|-10|
72584040|NCT00450437|144699071|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (-10%, 10%). If the two sided 95% CIs for the percentage of subjects with hSBA titer ≥1:8 at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 1 and Investigational vaccine MenACWY Lot 3 would be equivalent for Neisseria Meningitidis strain A with respect to the immune response to the vaccine lot.|Vaccine group difference|-6.0|||||TWO_SIDED|95.0|-12.0|0.0|||ANOVA|||Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with hSBA titer ≥1:8 comparing Investigational vaccine MenACWY Lot 1 to Investigational vaccine MenACWY Lot 3 for Neisseria Meningitidis strain A were contained within the equivalence interval (-10%, 10%).||0|-12|
72584041|NCT00450437|144699071|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (-10%, 10%). If the two sided 95% CIs for the percentage of subjects with hSBA titer ≥1:8 at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 2 and Investigational vaccine MenACWY Lot 3 would be equivalent for Neisseria Meningitidis strain A with respect to the immune response to the vaccine lot.|Vaccine group difference|-3.0|||||TWO_SIDED|95.0|-9.0|4.0|||ANOVA|||Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with hSBA titer ≥1:8 comparing Investigational vaccine MenACWY Lot 2 to Investigational vaccine MenACWY Lot 3 for Neisseria Meningitidis strain A were contained within the equivalence interval (-10%, 10%).||4|-9|
72413147|NCT02528214|144334943|SUPERIORITY|A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measure are reported and continued when previous outcome measure was statistically significant at two-sided 0.05. Only the primary and the first 4 secondary outcome measures were included in the procedure.|Least Square (LS) Mean Difference|28.24|||<|0.0001|TWO_SIDED|95.0|15.81|40.67||Threshold for significance at two-sided 0.05 level.|ANCOVA||LS mean difference represents reduction difference i.e. dupilumab - placebo.|The outcome measure was analyzed using analysis of covariance (ANCOVA) model which included percentage reduction of OCS dose at Week 24 as the response variable, and treatment group, baseline eosinophil level, optimized OCS dose at baseline, region as covariates. Missing data was imputed using a pattern mixture model by multiple imputation approach.||40.67|15.81|< 0.0001
72421543|NCT01181726|144354226|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|97.83|||||TWO_SIDED|90.0|94.55|101.21|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||101.21|94.55|
72551467|NCT00420238|144633156|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.87||||0.184|TWO_SIDED|95.0|0.74|4.7|||GEE model||An odds-ratio greater than 1 indicates the odds of response is greater in etanercept group than in placebo group.|Week 2: Generalized estimating equation (GEE) model, using a logit link, binomial distribution and an auto-regressive correlation structure, with treatment groups, visits and their interaction as fixed factors.||4.70|0.74|0.184
72551468|NCT00420238|144633156|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.62||||0.036||95.0|1.06|6.46|||GEE model||An odds-ratio greater than 1 indicates the odds of response is greater in etanercept group than in placebo group.|Week 4: Generalized estimating equation (GEE) model, using a logit link, binomial distribution and an auto-regressive correlation structure, with treatment groups, visits and their interaction as fixed factors.||6.46|1.06|0.036
72551469|NCT00420238|144633156|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.96||||0.001||95.0|1.89|13.03|||GEE model||An odds-ratio greater than 1 indicates the odds of response is greater in etanercept group than in placebo group.|Week 8: Generalized estimating equation (GEE) model, using a logit link, binomial distribution and an auto-regressive correlation structure, with treatment groups, visits and their interaction as fixed factors.||13.03|1.89|0.001
72551470|NCT00420238|144633156|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.38||||0.065||95.0|0.95|5.96|||GEE model||An odds-ratio greater than 1 indicates the odds of response is greater in etanercept group than in placebo group.|Week 12: Generalized estimating equation (GEE) model, using a logit link, binomial distribution and an auto-regressive correlation structure, with treatment groups, visits and their interaction as fixed factors.||5.96|0.95|0.065
72551471|NCT00420238|144633158|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.57||||0.004|TWO_SIDED|95.0|1.64|12.74|||GEE model||Odds ratio greater than 1 indicates the odds of response is greater in etanercept group than in placebo group.|Week 2: Generalized estimating equation (GEE) model, using a logit link, binomial distribution and an auto-regressive correlation structure, with treatment groups, visits and their interaction as fixed factors.||12.74|1.64|0.004
72551472|NCT00420238|144633158|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.46||||0.054||95.0|0.99|6.12|||GEE model||Odds ratio greater than 1 indicates the odds of response is greater in etanercept group than in placebo group.|Week 4: Generalized estimating equation (GEE) model, using a logit link, binomial distribution and an auto-regressive correlation structure, with treatment groups, visits and their interaction as fixed factors.||6.12|0.99|0.054
72551473|NCT00420238|144633158|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.26|||<|0.001||95.0|2.27|17.31|||GEE model||Odds ratio greater than 1 indicates the odds of response is greater in etanercept group than in placebo group.|Week 8: Generalized estimating equation (GEE) model, using a logit link, binomial distribution and an auto-regressive correlation structure, with treatment groups, visits and their interaction as fixed factors.||17.31|2.27|<0.001
72551474|NCT00420238|144633158|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.88||||0.025||95.0|1.14|7.27|||GEE model||Odds ratio greater than 1 indicates the odds of response is greater in etanercept group than in placebo group.|Week 12: Generalized estimating equation (GEE) model, using a logit link, binomial distribution and an auto-regressive correlation structure, with treatment groups, visits and their interaction as fixed factors.||7.27|1.14|0.025
72551475|NCT03018249|144633234|SUPERIORITY|||||||0.87|||||||Wilcoxon (Mann-Whitney)|||||||0.87
72551476|NCT03018249|144633235|SUPERIORITY||Mean Difference (Final Values)|2.7|||||TWO_SIDED|95.0|-25.0|30.0||||||||30|-25|
72551477|NCT03018249|144633236|SUPERIORITY||Mean Difference (Final Values)|21.8|||||TWO_SIDED|95.0|-16.7|45.3||||||||45.3|-16.7|
72551478|NCT03966365|144633273|OTHER|||||||0.706|||||||Wilcoxon (Mann-Whitney)|||||||0.706
72551479|NCT03966365|144633274|OTHER|||||||0.622|||||||Wilcoxon (Mann-Whitney)|||||||0.622
72551480|NCT03966365|144633275|OTHER|||||||0.081|||||||Chi-squared, Corrected|||Green lissamine treatment groups||||0.081
72551481|NCT03966365|144633275|OTHER|||||||0.49|||||||Chi-squared, Corrected|||Fluorescein treatment groups||||0.490
72551482|NCT03966365|144633276|OTHER|||||||0.253|||||||Wilcoxon (Mann-Whitney)|||||||0.253
72551483|NCT03966365|144633277|OTHER|||||||0.031|||||||Chi-squared, Corrected|||||||0.031
72551484|NCT03966365|144633279|OTHER|||||||0.651|||||||Wilcoxon (Mann-Whitney)|||||||0.651
72551485|NCT01523899|144633282|SUPERIORITY||Mean Difference (Final Values)|0.145|||||TWO_SIDED|95.0||||Pearson chi squared, Fisher exact, 2 sample t-tests||||||||
72551486|NCT01523899|144633283|SUPERIORITY||||||>|0.05|||||||Chi-squared|||||||>0.05
72551487|NCT00824265|144633285|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.67||||0.0032|TWO_SIDED|95.0|0.51|0.88|||Log Rank|||||0.88|0.51|0.0032
72551488|NCT00824265|144633286|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.8||||0.1427|TWO_SIDED|95.0|0.59|1.09|||Log Rank|||||1.09|0.59|0.1427
72551489|NCT00824265|144633287|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.08||||0.449|TWO_SIDED|95.0|0.85|1.37|||Log Rank|||||1.37|0.85|0.4490
72551490|NCT00824265|144633288|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.77||||0.0878|TWO_SIDED|95.0|0.56|1.05|||Log Rank|||||1.05|0.56|0.0878
72551491|NCT00824265|144633289|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.63||||0.0036|TWO_SIDED|95.0|0.45|0.87|||Log Rank|||||0.87|0.45|0.0036
72551492|NCT00824265|144633290|SUPERIORITY_OR_OTHER_LEGACY|Participants in the ITT population|Hazard Ratio (HR)|0.77||||0.1143|TWO_SIDED|95.0|0.55|1.08|||Log Rank|||||1.08|0.55|0.1143
72551493|NCT00824265|144633290|SUPERIORITY_OR_OTHER_LEGACY|Participants who took anti-cancer therapies|Hazard Ratio (HR)|0.67||||0.0109|TWO_SIDED|95.0|0.48|0.94|||Log Rank|||||0.94|0.48|0.0109
72551494|NCT00824265|144633293|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0003|||||||Cochran-Mantel-Haenszel|||||||0.0003
72551495|NCT00824265|144633294|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0166|||||||Cochran-Mantel-Haenszel|||||||0.0166
72551496|NCT01402947|144633316|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|If the 90% Confidence Intervals of the geometric mean ratio are wholly contained within the interval (0.80, 1.25), then the hypothesis of a drug interaction will be rejected.|Geometric Mean Ratio|1.013|||||TWO_SIDED|90.0|0.933|1.1|||ANOVA|||||1.100|0.933|
72551497|NCT01402947|144633317|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|If the 90% Confidence Intervals of the geometric mean ratio are wholly contained within the interval (0.80, 1.25), then the hypothesis of a drug interaction will be rejected.|Geometric Mean Ratio|0.999|||||TWO_SIDED|90.0|0.893|1.117|||ANOVA|||||1.117|0.893|
72551498|NCT02801877|144633320|SUPERIORITY|||||||0.3|||||||Log Rank|Chi square= 4.1 on 3 degrees of freedom||Log-rank test of adherence, defined as time to last engagement with mobile application suite.||||0.3
72551499|NCT02801877|144633321|SUPERIORITY|||||||0.9|||||||Mixed Models Analysis|F(3, 835)=0.19||Interactive effect of time and group, adjusting for baseline PHQ-9, randomization strata, main and interactive effects of time, coach, coach\*time, hub, and hub\*time.||||0.90
72551500|NCT02801877|144633322|SUPERIORITY|||||||0.53|||||||Mixed Models Analysis|F(3, 835)=0.73||Interactive effect of time and group, adjusting for baseline GAD-7, randomization strata, main and interactive effects of time, coach, coach\*time, hub, and hub\*time.||||0.53
72551501|NCT00705536|144633329|SUPERIORITY_OR_OTHER|||||||0.0006||||||Treatment comparison of Humalog alone and Humalog + rHuPH20 using a pairwise t-test.|ANOVA|||||||0.0006
72551502|NCT00705536|144633329|SUPERIORITY_OR_OTHER|||||||0.0002||||||Treatment comparison of Humulin-R alone and Humulin-R + rHuPH20 using a pairwise t-test.|ANOVA|||||||0.0002
72551503|NCT00705536|144633330|SUPERIORITY_OR_OTHER|||||||0.0003||||||Treatment comparison of Humalog alone and Humalog + rHuPH20 using a pairwise t-test.|ANOVA|||||||0.0003
72551504|NCT00705536|144633330|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Treatment comparison of Humulin-R alone and Humulin-R + rHuPH20 using a pairwise t-test.|ANOVA|||||||<0.0001
72551505|NCT00705536|144633331|SUPERIORITY_OR_OTHER|||||||0.0059||||||Treatment comparison of Humalog alone and Humalog + rHuPH20 using a pairwise t-test.|ANOVA|||||||0.0059
72551506|NCT00705536|144633331|SUPERIORITY_OR_OTHER|||||||0.0105||||||Treatment comparison of Humulin-R alone and Humulin-R + rHuPH20 using a pairwise t-test.|ANOVA|||||||0.0105
72551507|NCT00705536|144633332|SUPERIORITY_OR_OTHER|||||||0.0002||||||Treatment comparison for Humalog alone and Humalog + rHuPH20 using a pairwise t-test.|ANOVA|||||||0.0002
72551508|NCT00705536|144633332|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Treatment comparison of Humulin-R alone and Humulin-R + rHuPH20 using a pairwise t-test.|ANOVA|||||||<0.0001
72551509|NCT00705536|144633333|SUPERIORITY_OR_OTHER|||||||0.3019||||||Treatment comparison for Humalog alone and Humalog + rHuPH20 using a pairwise t-test.|ANOVA|||||||0.3019
72551510|NCT00705536|144633334|SUPERIORITY_OR_OTHER|||||||0.0401||||||Treatment comparison of Humalog alone and Humalog + rHuPH20 using a pairwise t-test.|ANOVA|||||||0.0401
72551511|NCT00705536|144633334|SUPERIORITY_OR_OTHER|||||||0.0004||||||Treatment comparison of Humulin-R alone and Humulin-R + rHuPH20 using a pairwise t-test.|ANOVA|||||||0.0004
72551512|NCT00705536|144633335|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Treatment comparison of Humalog alone and Humalog +rHuPH20 using a pairwise t-test.|ANOVA|||||||<0.0001
72551513|NCT00705536|144633335|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Treatment comparison of Humulin-R alone and Humulin-R + rHuPH20 using a pairwise t-test.|ANOVA|||||||<0.0001
72551514|NCT00705536|144633337|SUPERIORITY_OR_OTHER|||||||0.5589||||||Treatment comparison of Humalog alone and Humalog + rHuPH20 using a pairwise t-test.|ANOVA|||||||0.5589
72551515|NCT00705536|144633337|SUPERIORITY_OR_OTHER|||||||0.0067||||||Treatment comparison of Humulin-R alone and Humulin-R + rHuPH20 using a pairwise t-test.|ANOVA|||||||0.0067
72551516|NCT02289963|144633346|SUPERIORITY||Least Square (LS) Mean Difference|-63.4|||<|0.0001|TWO_SIDED|95.0|-71.6|-55.2||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab 75 mg Q2W/ Up to 150 mg Q2W vs. Placebo Q2W|Alirocumab group was compared to placebo group using an appropriate contrast statement.||-55.2|-71.6|<0.0001
72552969|NCT02459951|144637015|SUPERIORITY||geometric mean ratio C|||||0.022||||||"refer to cylinder C (1.5 diameter)"|Regression, Logistic|||||||.022
72552970|NCT02459951|144637015|SUPERIORITY||geometric mean ratio D|||||0.004||||||"refer to cylinder D (2 diameter)"|Regression, Logistic|||||||.004
72552971|NCT02459951|144637015|SUPERIORITY||geometric mean ratio E|||||0.002||||||"refer to cylinder E (2.5 diameter)"|Regression, Logistic|||||||.002
72551517|NCT02289963|144633347|SUPERIORITY||LS Mean Difference|-66.2|||<|0.0001|TWO_SIDED|95.0|-73.9|-58.4||Threshold for significance was at 0.05 level.|Mixed Models Analysis||Alirocumab 75 mg Q2W/Up to 150 mg Q2W vs. Placebo Q2W|A hierarchical testing procedure was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when previous endpoint was statistically significant at 0.05 level.||-58.4|-73.9|<0.0001
72551518|NCT02289963|144633348|SUPERIORITY||LS Mean Difference|-62.5|||<|0.0001|TWO_SIDED|95.0|-68.8|-56.3||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab 75 mg Q2W/Up to 150 mg Q2W vs. Placebo Q2W|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-56.3|-68.8|<0.0001
72551519|NCT02289963|144633349|SUPERIORITY||LS Mean Difference|-63.1|||<|0.0001|TWO_SIDED|95.0|-69.2|-57.0||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab 75 mg Q2W/Up to 150 mg Q2W vs. Placebo Q2W|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-57.0|-69.2|<0.0001
72551520|NCT02289963|144633350|SUPERIORITY||LS Mean Difference|-46.3|||<|0.0001|TWO_SIDED|95.0|-53.0|-39.7||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab 75 mg Q2W/Up to 150 mg Q2W vs. Placebo Q2W|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-39.7|-53.0|<0.0001
72551521|NCT02289963|144633351|SUPERIORITY||LS Mean Difference|-49.2|||<|0.0001|TWO_SIDED|95.0|-55.3|-43.1||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab 75 mg Q2W/Up to 150 mg Q2W vs. Placebo Q2W|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-43.1|-55.3|<0.0001
72551522|NCT02289963|144633352|SUPERIORITY||LS Mean Difference|-51.5|||<|0.0001|TWO_SIDED|95.0|-58.4|-44.6||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab 75 mg Q2W/Up to 150 mg Q2W vs. Placebo Q2W|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-44.6|-58.4|<0.0001
72551523|NCT02289963|144633353|SUPERIORITY||LS Mean Difference|-54.2|||<|0.0001|TWO_SIDED|95.0|-60.6|-47.8||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab 75 mg Q2W/Up to 150 mg Q2W vs. Placebo Q2W|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-47.8|-60.6|<0.0001
72551524|NCT02289963|144633354|SUPERIORITY||LS Mean Difference|-35.2|||<|0.0001|TWO_SIDED|95.0|-40.3|-30.1||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab 75 mg Q2W/Up to 150 mg Q2W vs. Placebo Q2W|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-30.1|-40.3|<0.0001
72551525|NCT02289963|144633355|SUPERIORITY||LS Mean Difference|-46.1|||<|0.0001|TWO_SIDED|95.0|-51.2|-41.0||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab 75 mg Q2W/Up to 150 mg Q2W vs. Placebo Q2W|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-41.0|-51.2|<0.0001
72551526|NCT02289963|144633356|SUPERIORITY||LS Mean Difference|-51.2|||<|0.0001|TWO_SIDED|95.0|-56.4|-46.1||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab 75 mg Q2W/Up to 150 mg Q2W vs. Placebo Q2W|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-46.1|-56.4|<0.0001
72551527|NCT02289963|144633357|SUPERIORITY||LS Mean Difference|-35.8|||<|0.0001|TWO_SIDED|95.0|-39.7|-31.9||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab 75 mg Q2W/Up to 150 mg Q2W vs. Placebo Q2W|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant.||-31.9|-39.7|<0.0001
72551528|NCT02289963|144633358|SUPERIORITY||Odds Ratio (OR)|46.9|||<|0.0001|TWO_SIDED|95.0|18.4|119.4||Threshold for significance at 0.05 level.|Regression, Logistic|Multiple imputation approach followed by logistic regression model.|Alirocumab 75 mg Q2W/Up to 150 mg Q2W vs. Placebo Q2W|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||119.4|18.4|<0.0001
72551529|NCT02289963|144633359|SUPERIORITY||Odds Ratio (OR)|70.0|||<|0.0001|TWO_SIDED|95.0|23.3|210.8||Threshold for significance at 0.05 level.|Regression, Logistic|Multiple imputation approach followed by logistic regression model|Alirocumab 75 mg Q2W/Up to 150 mg Q2W vs. Placebo Q2W|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||210.8|23.3|<0.0001
72551530|NCT02289963|144633360|SUPERIORITY||Adjusted Mean Difference|-33.611|||<|0.0001|TWO_SIDED|95.0|-41.883|-25.338||Threshold for significance at 0.05 level.|Regression, Robust|Multiple imputation approach followed by a robust regression model.|Alirocumab 75 mg Q2W/Up to 150 mg Q2W vs. Placebo Q2W|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-25.338|-41.883|<0.0001
72551531|NCT02289963|144633361|SUPERIORITY||LS Mean Difference|7.5||||0.0029|TWO_SIDED|95.0|2.6|12.4||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab 75 mg Q2W/Up to 150 mg Q2W vs. Placebo Q2W|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||12.4|2.6|0.0029
72551532|NCT02289963|144633362|SUPERIORITY||LS Mean Difference|-4.515||||0.311|TWO_SIDED|95.0|-13.25|4.219||Threshold for significance at 0.05 level.|Regression, Robust|Multiple imputation approach followed by a robust regression model.|Alirocumab 75 mg Q2W/Up to 150 mg Q2W vs. Placebo Q2W|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||4.219|-13.250|0.3110
72551533|NCT00549718|144633375|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0|||||Mixed Models Analysis|||||||<0.05
72551534|NCT00549718|144633376|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0|||||Mixed Models Analysis|||||||<0.05
72551535|NCT01507051|144633377|SUPERIORITY_OR_OTHER||Geometric LS-Mean Ratio|2.793|||<|0.0001||90.0|2.633|2.962|||ANOVA|||||2.962|2.633|<0.0001
72551536|NCT01507051|144633378|SUPERIORITY_OR_OTHER||Geometric LS-Mean Ratio|6.151|||<|0.0001||90.0|5.598|6.759|||ANOVA|||||6.759|5.598|<0.0001
72551537|NCT01507051|144633405|SUPERIORITY_OR_OTHER||Geometric LS-Mean Ratio (%)|95.17||||0.5008||95.0|82.2|110.2|||ANOVA|||||110.2|82.20|0.5008
72551538|NCT01507051|144633406|SUPERIORITY_OR_OTHER||Geometric LS-Mean Ratio (%)|99.46||||0.9429||95.0|85.47|115.7|||ANOVA|||||115.7|85.47|0.9429
72584042|NCT00450437|144699071|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (-10%, 10%). If the two sided 95% CIs for the percentage of subjects with hSBA titer ≥1:8 at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 1 and Investigational vaccine MenACWY Lot 2 would be equivalent for Neisseria Meningitidis strain C with respect to the immune response to the vaccine lot.|Vaccine group difference|2.0|||||TWO_SIDED|95.0|-3.0|6.0|||ANOVA|||Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with hSBA titer ≥1:8 comparing Investigational vaccine MenACWY Lot 1 to Investigational vaccine MenACWY Lot 2 for Neisseria Meningitidis strain C were contained within the equivalence interval (-10%, 10%).||6|-3|
72584043|NCT00450437|144699071|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (-10%, 10%). If the two sided 95% CIs for the percentage of subjects with hSBA titer ≥1:8 at one month following vaccination was within this equivalence interval for all pairs of vaccine lots, Investigational vaccine MenACWY Lot 1 and Investigational vaccine MenACWY Lot 3 would be equivalent for Neisseria Meningitidis strain C with respect to the immune response to the vaccine lot.|Vaccine group difference|3.0|||||TWO_SIDED|95.0|-2.0|7.0|||ANOVA|||Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with hSBA titer ≥1:8 comparing Investigational vaccine MenACWY Lot 1 to Investigational vaccine MenACWY Lot 3 for Neisseria Meningitidis strain C were contained within the equivalence interval (-10%, 10%).||7|-2|
72551539|NCT01507051|144633407|SUPERIORITY_OR_OTHER||Geometric LS-Mean Ratio (%)|100.4||||0.9525||95.0|88.0|114.5|||ANOVA|||||114.5|88.00|0.9525
72551540|NCT01507051|144633408|SUPERIORITY_OR_OTHER||Geometric LS-Mean Ratio (%)|95.87||||0.4397||95.0|85.99|106.9|||ANOVA|||||106.9|85.99|0.4397
72551541|NCT02653664|144633426|SUPERIORITY|||||||0.39||||||Statistical significance was set at p=.05|ANOVA|||Based on our prior work comparing similar interventions, assuming decreases in average pain intensity of 0.3 points (on a 0-10 scale) for ED, between 0.8 to 1.4 points for HYP, and between 0.6 to 1 for MM, with standard deviations (SD) ranging from 0.15 to 1, significance level of 0.05, and using ANOVA as the statistical method, we calculated that 80 participants per arm at immediate post-treatment would provide at least 80% power to detect between-groups differences as specified.||||.39
72551542|NCT02653664|144633427|SUPERIORITY|||||||0.05||||||Statistical significance was set at p=.05.|ANOVA|||||||.05
72551543|NCT02653664|144633428|SUPERIORITY||||||<|0.001||||||Statistical significance was set at p= .05|ANOVA|||||||<.001
72551544|NCT00485472|144633429|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.36||||0.5438||95.0|-5.3|10.02|||ANCOVA|||The ANCOVA analysis includes treatment and pooled site as factors and baseline score as covariate.||10.02|-5.30|0.5438
72551545|NCT00485472|144633430|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.83||||0.2022||95.0|-2.62|12.28|||ANCOVA|||The ANCOVA analysis includes treatment and pooled site as factors and baseline score as covariate.||12.28|-2.62|0.2022
72551546|NCT00485472|144633431|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.79||||0.665||95.0|-6.36|9.93|||ANCOVA|||The ANCOVA analysis includes treatment and pooled site as factors and baseline score as covariate.||9.93|-6.36|0.6650
72551547|NCT00485472|144633432|SUPERIORITY_OR_OTHER||Mean Difference (Net)|10.74||||0.3445||95.0|-11.65|33.13|||ANCOVA|||The ANCOVA analysis includes treatment and pooled site as factors and baseline score as covariate.||33.13|-11.65|0.3445
72551548|NCT00485472|144633434|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.488||||0.0418||95.0|0.245|0.974|||Likelihood ratio test|||Analysis of 'response' based on a likelihood ratio test with treatment and pooled site as factors.||0.974|0.245|0.0418
72551549|NCT00365300|144633451|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.004||||1|||||||Fisher Exact|||||||1.0
72551550|NCT01179048|144633452|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority of liraglutide versus placebo was considered confirmed, if the upper limit of the two-sided 95% CI for the hazard ratio was below 1.3 or if the p-value for the one-sided test of H0: HR \>=1.3 against Ha: HR \<1.3 was less than 2.5% (or equivalent to 5% in two-sided test). If non-inferiority was established for the primary outcome, a test for superiority was to be performed.|Hazard Ratio (HR)|0.868|||<|0.001|TWO_SIDED|95.0|0.778|0.968||p-value is reported for one-sided (α-level 0.025) test for non-inferiority (hazard ratio \>=1.3).|Regression, Cox|||The primary endpoint was evaluated using the Cox regression model to estimate the hazard ratio (HR) (liraglutide/placebo) and the 2-sided 95% confidence interval (CI) including treatment group as factor. Non-inferiority of liraglutide versus placebo was considered confirmed, if the upper limit of the two-sided 95% CI for the hazard ratio was below 1.3 or if the p-value for the one-sided test of H0: HR \>=1.3 against Ha: HR \<1.3 was less than 2.5% (or equivalent to 5% in two-sided test).||0.968|0.778|<0.001
72584044|NCT00450437|144699071|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (-10%, 10%). If the two sided 95% CIs for the percentage of subjects with hSBA titer ≥1:8 at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 2 and Investigational vaccine MenACWY Lot 3 would be equivalent for Neisseria Meningitidis strain C with respect to the immune response to the vaccine lot.|Vaccine group difference|1.0|||||TWO_SIDED|95.0|-3.0|6.0|||ANOVA|||Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with hSBA titer ≥1:8 comparing Investigational vaccine MenACWY Lot 2 to Investigational vaccine MenACWY Lot 3 for Neisseria Meningitidis strain C were contained within the equivalence interval (-10%, 10%).||6|-3|
72584045|NCT00450437|144699071|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (-10%, 10%). If the two sided 95% CIs for the percentage of subjects with hSBA titer ≥1:8 at one month following vaccination was within this equivalence interval for all pairs of vaccine lots, Investigational vaccine MenACWY Lot 1 and Investigational vaccine MenACWY Lot 2 would be equivalent for Neisseria Meningitidis strain W with respect to the immune response to the vaccine lot.|Vaccine group difference|-2.0|||||TWO_SIDED|95.0|-5.0|1.0|||ANOVA|||Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with hSBA titer ≥1:8 comparing Investigational vaccine MenACWY Lot 1 to Investigational vaccine MenACWY Lot 2 for Neisseria Meningitidis strain W were contained within the equivalence interval (-10%, 10%).||1|-5|
72584046|NCT00450437|144699071|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (-10%, 10%). If the two sided 95% CIs for the percentage of subjects with hSBA titer ≥1:8 at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 1 and Investigational vaccine MenACWY Lot 3 would be equivalent for Neisseria Meningitidis strain W with respect to the immune response to the vaccine lot.|Vaccine group difference|-1.0|||||TWO_SIDED|95.0|-4.0|2.0|||ANOVA|||Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with hSBA titer ≥1:8 comparing Investigational vaccine MenACWY Lot 1 to Investigational vaccine MenACWY Lot 3 for Neisseria Meningitidis strain W were contained within the equivalence interval (-10%, 10%).||2|-4|
72421544|NCT01181726|144354227|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|98.01|||||TWO_SIDED|90.0|94.54|101.6|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||101.60|94.54|
72413148|NCT02528214|144334945|SUPERIORITY|Testing was performed according to the hierarchical testing procedure (continued only if previous endpoints were statistically significant).|Odds Ratio (OR)|3.98|||<|0.0001|TWO_SIDED|95.0|2.06|7.67||Threshold for significance at 0.05.|Regression, Logistic||Dupilumab 300 mg q2w v Placebo q2w|The outcome measure was analyzed using a logistic regression model. The model included the binary status of whether or not a participant achieved the 50% OCS dose reduction criterion as the response variable, and treatment groups, optimized OCS dose at baseline, regions, and baseline eosinophil level subgroups as covariates. Missing data was imputed by using a pattern mixture model by multiple imputation approach.||7.67|2.06|< 0.0001
72584047|NCT00450437|144699071|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (-10%, 10%). If the two sided 95% CIs for the percentage of subjects with hSBA titer ≥1:8 at one month following vaccination was within this equivalence interval for all pairs of vaccine lots, Investigational vaccine MenACWY Lot 2 and Investigational vaccine MenACWY Lot 3 would be equivalent for Neisseria Meningitidis strain W with respect to the immune response to the vaccine lot.|Vaccine group difference|1.0|||||TWO_SIDED|95.0|-2.0|4.0|||ANOVA|||Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with hSBA titer ≥1:8 comparing Investigational vaccine MenACWY Lot 2 to Investigational vaccine MenACWY Lot 3 for Neisseria Meningitidis strain W were contained within the equivalence interval (-10%, 10%).||4|-2|
72584048|NCT00450437|144699071|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (-10%, 10%). If the two sided 95% CIs for the percentage of subjects with hSBA titer ≥1:8 at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 1 and Investigational vaccine MenACWY Lot 2 would be equivalent for Neisseria Meningitidis strain Y with respect to the immune response to the vaccine lot.|Vaccine group difference|-3.0|||||TWO_SIDED|95.0|-8.0|2.0|||ANOVA|||Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with hSBA titer ≥1:8 comparing Investigational vaccine MenACWY Lot 1 to Investigational vaccine MenACWY Lot 2 for Neisseria Meningitidis strain Y were contained within the equivalence interval (-10%, 10%).||2|-8|
72584049|NCT00450437|144699071|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (-10%, 10%). If the two sided 95% CIs for the percentage of subjects with hSBA titer ≥1:8 at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 1 and Investigational vaccine MenACWY Lot 3 would be equivalent for Neisseria Meningitidis strain Y with respect to the immune response to the vaccine lot.|Vaccine group difference|-3.0|||||TWO_SIDED|95.0|-8.0|2.0|||ANOVA|||Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with hSBA titer ≥1:8 comparing Investigational vaccine MenACWY Lot 1 to Investigational vaccine MenACWY Lot 3 for Neisseria Meningitidis strain Y were contained within the equivalence interval (-10%, 10%).||2|-8|
72584050|NCT00450437|144699071|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (-10%, 10%). If the two sided 95% CIs for the percentage of subjects with hSBA titer ≥1:8 at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 2 and Investigational vaccine MenACWY Lot 3 would be equivalent for Neisseria Meningitidis strain Y with respect to the immune response to the vaccine lot.|Vaccine group difference|0.0|||||TWO_SIDED|95.0|-5.0|5.0|||ANOVA|||Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with hSBA titer ≥1:8 comparing Investigational vaccine MenACWY Lot 2 to Investigational vaccine MenACWY Lot 3 for Neisseria Meningitidis strain Y were contained within the equivalence interval (-10%, 10%).||5|-5|
72584051|NCT00450437|144699071|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (-10%, 10%). If the two sided 95% CIs for the percentage of subjects with hSBA titer ≥1:4 at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 1 and Investigational vaccine MenACWY Lot 2 would be equivalent for Neisseria Meningitidis strain A with respect to the immune response to the vaccine lot.|Vaccine group difference|-2.0|||||TWO_SIDED|95.0|-9.0|4.0|||ANOVA|||Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with hSBA titer ≥1:4 comparing Investigational vaccine MenACWY Lot 1 to Investigational vaccine MenACWY Lot 2 for Neisseria Meningitidis strain A were contained within the equivalence interval (-10%, 10%).||4|-9|
72584052|NCT00450437|144699071|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (-10%, 10%). If the two sided 95% CIs for the percentage of subjects with hSBA titer ≥1:4 at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 1 and Investigational vaccine MenACWY Lot 3 would be equivalent for Neisseria Meningitidis strain A with respect to the immune response to the vaccine lot.|Vaccine group difference|-5.0|||||TWO_SIDED|95.0|-11.0|1.0|||ANOVA|||Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with hSBA titer ≥1:4 comparing Investigational vaccine MenACWY Lot 1 to Investigational vaccine MenACWY Lot 3 for Neisseria Meningitidis strain A were contained within the equivalence interval (-10%, 10%).||1|-11|
72584053|NCT00450437|144699071|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (-10%, 10%). If the two sided 95% CIs for the percentage of subjects with hSBA titer ≥1:4 at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 2 and Investigational vaccine MenACWY Lot 3 would be equivalent for Neisseria Meningitidis strain A with respect to the immune response to the vaccine lot.|Vaccine group difference|-2.0|||||TWO_SIDED|95.0|-8.0|4.0|||ANOVA|||Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with hSBA titer ≥1:4 comparing Investigational vaccine MenACWY Lot 2 to Investigational vaccine MenACWY Lot 3 for Neisseria Meningitidis strain A were contained within the equivalence interval (-10%, 10%).||4|-8|
72551551|NCT01179048|144633452|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.868||||0.005|TWO_SIDED|95.0|0.778|0.968||p-value is reported for one-sided (α-level 0.025) test for superiority (hazard ratio\>=1.0).|Regression, Cox|||If non-inferiority was established for the primary outcome, a test for superiority was performed. Superiority of liraglutide versus placebo was considered confirmed, if the upper limit of the two-sided 95% CI for the hazard ratio was below 1.0 or equivalent if the p-value for the one-sided test of H0: HR \>=1.0 against Ha: HR \<1.0 was less than 2.5% (or equivalent to 5% in two-sided test).||0.968|0.778|0.005
72551552|NCT01179048|144633453|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.881|||||TWO_SIDED|95.0|0.807|0.962|||Regression, Cox|The analysis was done using a Cox regression model with treatment as a fixed factor including all randomised subjects.||||0.962|0.807|
72551553|NCT01179048|144633454|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.847|||||TWO_SIDED|95.0|0.739|0.971|||Regression, Cox|The analysis was done using a Cox regression model with treatment as a fixed factor including all randomised subjects.||||0.971|0.739|
72551554|NCT01179048|144633455|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.783|||||TWO_SIDED|95.0|0.656|0.934|||Regression, Cox|||Analysis for percentage of subjects experiencing cardiovascular death was done by Cox regression model with treatment as fixed factor.||0.934|0.656|
72551555|NCT01179048|144633455|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.894|||||TWO_SIDED|95.0|0.721|1.107|||Regression, Cox|||Analysis for percentage of subjects experiencing non-fatal stroke was done by Cox regression model with treatment as fixed factor||1.107|0.721|
72551556|NCT01179048|144633455|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.878|||||TWO_SIDED|95.0|0.747|1.031|||Regression, Cox|||Analysis for percentage of subjects experiencing non-fatal myocardial infarction was done by Cox regression model with treatment as fixed factor||1.031|0.747|
72584054|NCT00450437|144699071|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (-10%, 10%). If the two sided 95% CIs for the percentage of subjects with hSBA titer ≥1:4 at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 1 and Investigational vaccine MenACWY Lot 2 would be equivalent for Neisseria Meningitidis strain C with respect to the immune response to the vaccine lot.|Vaccine group difference|1.0|||||TWO_SIDED|95.0|-3.0|5.0|||ANOVA|||Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with hSBA titer ≥1:4 comparing Investigational vaccine MenACWY Lot 1 to Investigational vaccine MenACWY Lot 2 for Neisseria Meningitidis strain C were contained within the equivalence interval (-10%, 10%)||5|-3|
72584055|NCT00450437|144699071|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (-10%, 10%). If the two sided 95% CIs for the percentage of subjects with hSBA titer ≥1:4 at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 1 and Investigational vaccine MenACWY Lot 3 would be equivalent for Neisseria Meningitidis strain C with respect to the immune response to the vaccine lot.|Vaccine group difference|0.0|||||TWO_SIDED|95.0|-4.0|4.0|||ANOVA|||Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with hSBA titer ≥1:4 comparing Investigational vaccine MenACWY Lot 1 to Investigational vaccine MenACWY Lot 3 for Neisseria Meningitidis strain C were contained within the equivalence interval (-10%, 10%).||4|-4|
72584056|NCT00450437|144699071|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (-10%, 10%). If the two sided 95% CIs for the percentage of subjects with hSBA titer ≥1:4 at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 2 and Investigational vaccine MenACWY Lot 3 would be equivalent for Neisseria Meningitidis strain C with respect to the immune response to the vaccine lot.|Vaccine group difference|0.0|||||TWO_SIDED|95.0|-4.0|4.0|||ANOVA|||Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with hSBA titer ≥1:4 comparing Investigational vaccine MenACWY Lot 2 to Investigational vaccine MenACWY Lot 3 for Neisseria Meningitidis strain C were contained within the equivalence interval (-10%, 10%).||4|-4|
72584057|NCT00450437|144699071|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (-10%, 10%). If the two sided 95% CIs for the percentage of subjects with hSBA titer ≥1:4 at one month following vaccination was within this equivalence interval for all pairs of vaccine lots, Investigational vaccine MenACWY Lot 1 and Investigational vaccine MenACWY Lot 2 would be equivalent for Neisseria Meningitidis strain W with respect to the immune response to the vaccine lot.|Vaccine group difference|-2.0|||||TWO_SIDED|95.0|-5.0|1.0|||ANOVA|||Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with hSBA titer ≥1:4 comparing Investigational vaccine MenACWY Lot 1 to Investigational vaccine MenACWY Lot 2 for Neisseria Meningitidis strain W were contained within the equivalence interval (-10%, 10%).||1|-5|
72551557|NCT01179048|144633455|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.98|||||TWO_SIDED|95.0|0.763|1.258|||Regression, Cox|||Analysis for percentage of subjects experiencing hospitalisation for unstable angina pectoris was done by Cox regression model with treatment as fixed factor||1.258|0.763|
72551558|NCT01179048|144633455|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.912|||||TWO_SIDED|95.0|0.797|1.044|||Regression, Cox|||Analysis for percentage of subjects experiencing coronary revascularisation was done by Cox regression model with treatment as fixed factor||1.044|0.797|
72551559|NCT01179048|144633455|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.872|||||TWO_SIDED|95.0|0.727|1.046|||Regression, Cox|||Analysis for percentage of subjects experiencing hospitalisation for heart failure was done by Cox regression model with treatment as fixed factor||1.046|0.727|
72584058|NCT00450437|144699071|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (-10%, 10%). If the two sided 95% CIs for the percentage of subjects with hSBA titer ≥1:4 at one month following vaccination was within this equivalence interval for all pairs of vaccine lots, Investigational vaccine MenACWY Lot 1 and Investigational vaccine MenACWY Lot 3 would be equivalent for Neisseria Meningitidis strain W with respect to the immune response to the vaccine lot.|Vaccine group difference|-1.0|||||TWO_SIDED|95.0|-4.0|2.0|||ANOVA|||Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with hSBA titer ≥1:4 comparing Investigational vaccine MenACWY Lot 1 to Investigational vaccine MenACWY Lot 3 for Neisseria Meningitidis strain W were contained within the equivalence interval (-10%, 10%).||2|-4|
72584059|NCT00450437|144699071|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (-10%, 10%). If the two sided 95% CIs for the percentage of subjects with hSBA titer ≥1:4 at one month following vaccination was within this equivalence interval for all pairs of vaccine lots, Investigational vaccine MenACWY Lot 2 and Investigational vaccine MenACWY Lot 3 would be equivalent for Neisseria Meningitidis strain W with respect to the immune response to the vaccine lot.|Vaccine group difference|1.0|||||TWO_SIDED|95.0|-2.0|3.0|||ANOVA|||Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with hSBA titer ≥1:4 comparing Investigational vaccine MenACWY Lot 2 to Investigational vaccine MenACWY Lot 3 for Neisseria Meningitidis strain W were contained within the equivalence interval (-10%, 10%).||3|-2|
72584060|NCT00450437|144699071|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (-10%, 10%). If the two sided 95% CIs for the percentage of subjects with hSBA titer ≥1:4 at one month following vaccination was within this equivalence interval for all pairs of vaccine lots, Investigational vaccine MenACWY Lot 1 and Investigational vaccine MenACWY Lot 2 would be equivalent for Neisseria Meningitidis strain Y with respect to the immune response to the vaccine lot.|Vaccine group difference|-3.0|||||TWO_SIDED|95.0|-8.0|1.0|||ANOVA|||Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with hSBA titer ≥1:4 comparing Investigational vaccine MenACWY Lot 1 to Investigational vaccine MenACWY Lot 2 for Neisseria Meningitidis strain Y were contained within the equivalence interval (-10%, 10%).||1|-8|
72584061|NCT00450437|144699071|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (-10%, 10%). If the two sided 95% CIs for the percentage of subjects with hSBA titer ≥1:4 at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 1 and Investigational vaccine MenACWY Lot 3 would be equivalent for Neisseria Meningitidis strain Y with respect to the immune response to the vaccine lot.|Vaccine group difference|-4.0|||||TWO_SIDED|95.0|-9.0|0.0|||ANOVA|||Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with hSBA titer ≥1:4 comparing Investigational vaccine MenACWY Lot 1 to Investigational vaccine MenACWY Lot 3 for Neisseria Meningitidis strain Y were contained within the equivalence interval (-10%, 10%).||0|-9|
72584062|NCT00450437|144699071|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (-10%, 10%). If the two sided 95% CIs for the percentage of subjects with hSBA titer ≥1:4 at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 2 and Investigational vaccine MenACWY Lot 3 would be equivalent for Neisseria Meningitidis strain Y with respect to the immune response to the vaccine lot.|Vaccine group difference|-1.0|||||TWO_SIDED|95.0|-5.0|3.0|||ANOVA|||Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with hSBA titer ≥1:4 comparing Investigational vaccine MenACWY Lot 2 to Investigational vaccine MenACWY Lot 3 for Neisseria Meningitidis strain Y were contained within the equivalence interval (-10%, 10%).||3|-5|
72584063|NCT00450437|144699072|NON_INFERIORITY_OR_EQUIVALENCE|Immunogenicity of the Investigational MenACWY vaccine would be considered non-inferior to that of the Licensed MenACWY vaccine if the lower limit of the two-sided CI for percentage of subjects with seroresponse one month after vaccination is \> -10%.|Vaccine group difference|4.0|||||TWO_SIDED|95.0|0.0|8.0|||ANOVA|||Vaccine group difference Investigational MenACWY vaccine vs. Licensed MenaCWY vaccine, MenA.||8|0|
72584064|NCT00450437|144699072|NON_INFERIORITY_OR_EQUIVALENCE|Immunogenicity of the Investigational MenACWY vaccine would be considered non-inferior to that of the Licensed MenACWY vaccine if the lower limit of the two-sided CI for percentage of subjects with seroresponse one month after vaccination is \> -10%.|Vaccine group difference|5.0|||||TWO_SIDED|95.0|1.0|9.0|||ANOVA|||Vaccine group difference Investigational MenACWY vaccine vs. Licensed MenaCWY vaccine, MenC.||9|1|
72584065|NCT00450437|144699072|NON_INFERIORITY_OR_EQUIVALENCE|Immunogenicity of the Investigational MenACWY vaccine would be considered non-inferior to that of the Licensed MenACWY vaccine if the lower limit of the two-sided CI for percentage of subjects with seroresponse one month after vaccination is \> -10%.|Vaccine group difference|15.0|||||TWO_SIDED|95.0|11.0|20.0|||ANOVA|||Vaccine group difference Investigational MenACWY vaccine vs.Licensed MenaCWY vaccine, MenW.||20|11|
72584066|NCT00450437|144699072|NON_INFERIORITY_OR_EQUIVALENCE|Immunogenicity of the Investigational MenACWY vaccine would be considered non-inferior to that of the Licensed MenACWY vaccine if the lower limit of the two-sided CI for percentage of subjects with seroresponse one month after vaccination is \> -10%.|Vaccine group difference|23.0|||||TWO_SIDED|95.0|19.0|28.0|||ANOVA|||Vaccine group difference Investigational MenACWY vaccine vs. Licensed MenaCWY vaccine, MenY.||28|19|
72584067|NCT00450437|144699072|NON_INFERIORITY_OR_EQUIVALENCE|Immunogenicity of the Investigational MenACWY vaccine would be considered non-inferior to that of the Licensed MenACWY vaccine if the lower limit of the two-sided CI for percentage of subjects with hSBA ≥ 1:8 one month after vaccination is \> -10%.|Vaccine group difference|4.0|||||TWO_SIDED|95.0|0.0|8.0|||ANOVA|||Vaccine group difference Investigational MenACWY vaccine vs. Licensed MenaCWY vaccine, MenA.||8|0|
72584068|NCT00450437|144699072|NON_INFERIORITY_OR_EQUIVALENCE|Immunogenicity of the Investigational MenACWY vaccine would be considered non-inferior to that of the Licensed MenACWY vaccine if the lower limit of the two-sided CI for percentage of subjects with hSBA ≥ 1:8 one month after vaccination is \> -10%.|Vaccine group difference|3.0|||||TWO_SIDED|95.0|0.0|7.0|||ANOVA|||Vaccine group difference Investigational MenACWY vaccine vs. Licensed MenaCWY vaccine, MenC.||7|0|
72584069|NCT00450437|144699072|NON_INFERIORITY_OR_EQUIVALENCE|Immunogenicity of the Investigational MenACWY vaccine would be considered non-inferior to that of the Licensed MenACWY vaccine if the lower limit of the two-sided CI for percentage of subjects with with hSBA ≥ 1:8 one month after vaccination is \> -10%.|Vaccine group difference|6.0|||||TWO_SIDED|95.0|4.0|9.0|||ANOVA|||Vaccine group difference Investigational MenACWY vaccine vs. Licensed MenaCWY vaccine, MenW.||9|4|
72584070|NCT00450437|144699072|NON_INFERIORITY_OR_EQUIVALENCE|Immunogenicity of the Investigational MenACWY vaccine would be considered non-inferior to that of the Licensed MenACWY vaccine if the lower limit of the two-sided CI for percentage of subjects with hSBA ≥ 1:8 one month after vaccination is \> -10%.|Vaccine group difference|15.0|||||TWO_SIDED|95.0|12.0|20.0|||ANOVA|||Vaccine group difference Investigational MenACWY vaccine vs. Licensed MenaCWY vaccine, MenY.||20|12|
72584071|NCT00450437|144699072|NON_INFERIORITY_OR_EQUIVALENCE|Immunogenicity of the Investigational MenACWY vaccine would be considered non-inferior to that of the Licensed MenACWY vaccine if the lower limit of the two-sided CI for percentage of subjects with hSBA ≥ 1:4 one month after vaccination is \> -10%.|Vaccine group difference|3.0|||||TWO_SIDED|95.0|-1.0|7.0|||ANOVA|||Vaccine group difference Investigational MenACWY vaccine vs. Licensed MenaCWY vaccine, MenA.||7|-1|
72584072|NCT00450437|144699072|NON_INFERIORITY_OR_EQUIVALENCE|Immunogenicity of the Investigational MenACWY vaccine would be considered non-inferior to that of the Licensed MenACWY vaccine if the lower limit of the two-sided CI for percentage of subjects with hSBA ≥ 1:4 one month after vaccination is \> -10%.|Vaccine group difference|1.0|||||TWO_SIDED|95.0|-1.0|4.0|||ANOVA|||Vaccine group difference Investigational MenACWY vaccine vs. Licensed MenaCWY vaccine, MenC.||4|-1|
72584073|NCT00450437|144699072|NON_INFERIORITY_OR_EQUIVALENCE|Immunogenicity of the Investigational MenACWY vaccine would be considered non-inferior to that of the Licensed MenACWY vaccine if the lower limit of the two-sided CI for percentage of subjects with hSBA ≥ 1:4 one month after vaccination is \> -10%.|Vaccine group difference|6.0|||||TWO_SIDED|95.0|3.0|8.0|||ANOVA|||Vaccine group difference Investigational MenACWY vaccine vs. Licensed MenaCWY vaccine, MenW.||8|3|
72584074|NCT00450437|144699072|NON_INFERIORITY_OR_EQUIVALENCE|Immunogenicity of the Investigational MenACWY vaccine would be considered non-inferior to that of the Licensed MenACWY vaccine if the lower limit of the two-sided CI for percentage of subjects with hSBA ≥ 1:4 one month after vaccination is \> -10%.|Vaccine group difference|12.0|||||TWO_SIDED|95.0|9.0|16.0|||ANOVA|||Vaccine group difference Investigational MenACWY vaccine vs. Licensed MenaCWY vaccine, MenY.||16|9|
72584075|NCT00450437|144699073|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence lower limit was 0.5. If the lower limit of two sided 95% CIs for the ratio of the hSBA GMT (GMT for investigational vaccine / GMT for licensed vaccine) at one month following vaccination was above this limit, Investigational MenACWY vaccine would be non-inferior to Licensed MenACWY vaccine for Neisseria Meningitidis strain A with respect to the immune response.|hSBA GMT ratios|1.32|||||TWO_SIDED|95.0|1.12|1.56|||ANOVA|||"Non-inferiority of Investigational MenACWY Vaccine vs. Licensed MenACWY vaccine, MenA.~The study would be considered a success if the lower limit of the two-sided 95% CIs for the hSBA GMT ratios comparing Investigational MenACWY vaccine to Licensed MenACWY vaccine for Neisseria Meningitidis strain A at 1 month after vaccination was to be above 0.5."||1.56|1.12|
72551560|NCT01179048|144633456|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.841|||||TWO_SIDED|95.0|0.73|0.969|||Regression, Cox|||Analysis for percentage of subjects experiencing a first microvascular event was done by Cox regression model with treatment as fixed factor.||0.969|0.730|
72551561|NCT01179048|144633457|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.782|||||TWO_SIDED|95.0|0.666|0.918|||Regression, Cox|||Analysis for percentage of subjects experiencing a composite nephropathy event was done by Cox regression model with treatment as fixed factor.||0.918|0.666|
72551562|NCT01179048|144633457|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.738|||||TWO_SIDED|95.0|0.602|0.905|||Regression, Cox|||Analysis for percentage of subjects experiencing a new onset of persistant macroalbuminaria event was done by Cox regression model with treatment as fixed factor.||0.905|0.602|
72551563|NCT01179048|144633457|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.89|||||TWO_SIDED|95.0|0.667|1.189|||Regression, Cox|||Analysis for percentage of subjects experiencing persistent doubling of serum creatinine was done by Cox regression model with treatment as fixed factor.||1.189|0.667|
72551564|NCT01179048|144633457|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.869|||||TWO_SIDED|95.0|0.607|1.244|||Regression, Cox|||Analysis for percentage of subjects experiencing a need for continuous renal-replacement therapy was done by Cox regression model with treatment as fixed factor.||1.244|0.607|
72551565|NCT01179048|144633457|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.593|||||TWO_SIDED|95.0|0.521|4.869|||Regression, Cox|||Analysis for percentage of subjects experiencing death due to renal disease was done by Cox regression model with treatment as fixed factor.||4.869|0.521|
72551566|NCT01179048|144633457|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.149|||||TWO_SIDED|95.0|0.869|1.519|||Regression, Cox|||Analysis for percentage of subjects experiencing composite retinopathy was done by Cox regression model with treatment as fixed factor.||1.519|0.869|
72551567|NCT01179048|144633457|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.159|||||TWO_SIDED|95.0|0.869|1.546|||Regression, Cox|||Analysis for percentage of subjects experiencing treatment with photocoagulation or intravitreal agents was done by Cox regression model with treatment as fixed factor.||1.546|0.869|
72551568|NCT01179048|144633457|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.335|||||TWO_SIDED|95.0|0.004|30.847|||Regression, Cox|||Analysis for percentage of subjects experiencing development of diabetes-related blindness was done by Cox regression model with treatment as fixed factor.||30.847|0.004|
72551569|NCT01179048|144633457|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.454|||||TWO_SIDED|95.0|0.845|2.502|||Regression, Cox|||Analysis for percentage of subjects experiencing vitreous haemorrhage was done by Cox regression model with treatment as fixed factor.||2.502|0.845|
72551570|NCT02627924|144633458|OTHER||||||<|0.0001|||||||Paired t-test|The mean change was tested with a paired t-test without adjusting for baseline disease severity.||||||<0.0001
72551571|NCT02627924|144633459|OTHER||||||<|0.0001|||||||Paired t-test|The mean change was tested with a paired t-test without adjusting for baseline disease severity.||||||<0.0001
72551572|NCT02627924|144633461|OTHER||||||<|0.0001|||||||Paired t-test|||Change From Baseline in Physical Component Score at Week 12||||<0.0001
72551573|NCT02627924|144633461|OTHER||||||<|0.0001|||||||Paired t-test|||Change From Baseline in Physical Component Score at Week 24||||<0.0001
72551574|NCT02627924|144633461|OTHER|||||||0.0001|||||||Paired t-test|||Change From Baseline in Mental Component Score at Week 12||||0.0001
72551575|NCT02627924|144633461|OTHER||||||<|0.0001|||||||Paired t-test|||Change From Baseline in Mental Component Score at Week 24||||<0.0001
72551576|NCT02627924|144633462|OTHER||||||<|0.0001|||||||Paired t-test|||Change from Baseline in EQ-5D-3L at 12 weeks||||<0.0001
72551577|NCT02627924|144633462|OTHER||||||<|0.0001|||||||Paired t-test|||Change from Baseline in EQ-5D-3L at 24 weeks||||<0.0001
72551578|NCT02627924|144633463|OTHER|||||||0.0098|||||||Paired t-test|||Change From Baseline in Overall Work Impairment at Week 12||||0.0098
72551579|NCT02627924|144633463|OTHER|||||||0.0015|||||||Paired t-test|||Change From Baseline in Overall Work Impairment at Week 24||||0.0015
72551580|NCT02627924|144633463|OTHER||||||<|0.0001|||||||Paired t-test|||Change From Baseline in Activity Impairment at Week 12||||<0.0001
72551581|NCT02627924|144633463|OTHER||||||<|0.0001|||||||Paired t-test|||Change From Baseline in Activity Impairment at Week 24||||<0.0001
72551582|NCT00528606|144633470|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel|||p-value based on Cochran-Mantel-Haenszel test comparing treatment groups, stratified by baseline severity group and joint type.||||<0.001
72551583|NCT00959660|144633484|SUPERIORITY||||||<|0.001||||||Main effects analysis with Diet vs. No Diet.|ANCOVA|Least Square Mean at follow up adjusted for the following covariates: baseline measure of the outcome measure, sex, and beta blocker usage.||||||<0.001
72551584|NCT00959660|144633484|SUPERIORITY||||||<|0.001||||||Main effects analysis with Exercise vs. No Exercise.|ANCOVA|Least Square Mean at follow up adjusted for the following covariates: baseline measure of the outcome measure, sex, and beta blocker usage.||||||<0.001
72551585|NCT00959660|144633485|SUPERIORITY|||||||0.004||||||Main effects analyses with Diet vs. No Diet.|ANCOVA|Least Square Mean at follow up adjusted for the following covariates: baseline measure of the outcome measure, sex, and beta blocker usage.||||||0.004
72551586|NCT00959660|144633485|SUPERIORITY|||||||0.43||||||Main effects analysis for Exercise vs. No Exercise.|ANCOVA|Least Square Mean at follow up adjusted for the following covariates: baseline measure of the outcome measure, sex, and beta blocker usage.||||||0.43
72551587|NCT00959660|144633486|SUPERIORITY||||||<|0.001||||||Main effects analyses with Diet vs. No Diet.|ANCOVA|Least Square Mean at follow up adjusted for the following covariates: baseline measure of the outcome measure, sex, and beta blocker usage.||Total Body Fat Mass||||<0.001
72551588|NCT00959660|144633486|SUPERIORITY|||||||0.001||||||Main effects analysis of Exercise vs. No Exercise.|ANCOVA|Least Square Mean at follow up adjusted for the following covariates: baseline measure of the outcome measure, sex, and beta blocker usage.||Total Body Fat Mass||||0.001
72551589|NCT00959660|144633486|SUPERIORITY||||||<|0.001||||||Main effects analyses with Diet vs. No Diet.|ANCOVA|Least Square Mean at follow up adjusted for the following covariates: baseline measure of the outcome measure, sex, and beta blocker usage.||Total Non-Bone Lean Mass||||<0.001
72551590|NCT00959660|144633486|SUPERIORITY|||||||0.25||||||Main effects analysis for Exercise vs. No Exercise.|ANCOVA|Least Square Mean at follow up adjusted for the following covariates: baseline measure of the outcome measure, sex, and beta blocker usage.||Total Non-Bone Lean Mass||||0.25
72551591|NCT00959660|144633487|SUPERIORITY||||||<|0.001||||||Main effects analyses with Diet vs. No Diet.|ANCOVA|Least Square Mean at follow up adjusted for the following covariates: baseline measure of the outcome measure, sex, and beta blocker usage.||Thigh Subcutaneous Fat||||<0.001
72551592|NCT00959660|144633487|SUPERIORITY|||||||0.26||||||Main effects analysis for Exercise vs. No Exercise.|ANCOVA|Least Square Mean at follow up adjusted for the following covariates: baseline measure of the outcome measure, sex, and beta blocker usage.||Thigh Subcutaneous Fat||||0.26
72551593|NCT00959660|144633487|SUPERIORITY||||||<|0.001||||||Main effects analyses with Diet vs. No Diet.|ANCOVA|Least Square Mean at follow up adjusted for the following covariates: baseline measure of the outcome measure, sex, and beta blocker usage.||Thigh Skeletal Muscle||||<0.001
72551594|NCT00959660|144633487|SUPERIORITY|||||||0.26||||||Main effects analysis of Exercise vs. No Exercise.|ANCOVA|Least Square Mean at follow up adjusted for the following covariates: baseline measure of the outcome measure, sex, and beta blocker usage.||Thigh Skeletal Muscle||||0.26
72551595|NCT01297348|144633488|SUPERIORITY_OR_OTHER||Incidence rate ratio|2.01|||||TWO_SIDED|95.0|1.23|3.29||||||Incidence rate ratio (Lybrel/EE-20) along with corresponding 95 percent (%) confidence interval (CI) was reported for current users.||3.29|1.23|
72551596|NCT01297348|144633488|SUPERIORITY_OR_OTHER||Incidence rate ratio|2.99|||||TWO_SIDED|95.0|0.39|22.8||||||Incidence rate ratio (Lybrel/EE-20) along with corresponding 95% CI was reported for past users.||22.80|0.39|
72584076|NCT00450437|144699073|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence lower limit was 0.5. If the lower limit of two sided 95% CIs for the ratio of the hSBA GMT (GMT for investigational vaccine / GMT for licensed vaccine) at one month following vaccination was above this limit, Investigational MenACWY vaccine would be non-inferior to Licensed MenACWY vaccine for Neisseria Meningitidis strain C with respect to the immune response.|hSBA GMT ratios|1.4|||||TWO_SIDED|95.0|1.17|1.67|||ANOVA|||"Non-inferiority of Investigation MenACWY vaccine vs. Licensed MenACWY vaccine, MenC.~The study would be considered a success if the lower limit of the two-sided 95% CIs for the hSBA GMT ratios comparing Investigational MenACWY vaccine to Licensed MenACWY vaccine for Neisseria Meningitidis strain C at 1 month after vaccination was to be above 0.5."||1.67|1.17|
72584077|NCT00450437|144699073|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence lower limit was 0.5. If the lower limit of two sided 95% CIs for the ratio of the hSBA GMT (GMT for investigational vaccine / GMT for licensed vaccine) at one month following vaccination was above this limit, Investigational MenACWY vaccine would be non-inferior to Licensed MenACWY vaccine for Neisseria Meningitidis strain W with respect to the immune response.|hSBA GMT ratios|1.76|||||TWO_SIDED|95.0|1.51|2.05|||ANOVA|||"Non-inferiority of Investigational MenACWY vaccine vs. Licensed MenACWY vaccine, MenW.~The study would be considered a success if the lower limit of the two-sided 95% CIs for the hSBA GMT ratios comparing Investigational MenACWY vaccine to Licensed MenACWY vaccine for Neisseria Meningitidis strain W at 1 month after vaccination was to be above 0.5."||2.05|1.51|
72551597|NCT01297348|144633488|SUPERIORITY_OR_OTHER||Incidence rate ratio|3.49|||||TWO_SIDED|95.0|2.02|6.02||||||Incidence rate ratio (Lybrel/Levo-20) along with corresponding 95% CI was reported for current users.||6.02|2.02|
72551598|NCT01297348|144633488|SUPERIORITY_OR_OTHER||Incidence rate ratio|3.07|||||TWO_SIDED|95.0|0.34|27.47||||||Incidence rate ratio (Lybrel/Levo-20) along with corresponding 95% CI was reported for past users.||27.47|0.34|
72551599|NCT01297348|144633489|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.51|||||TWO_SIDED|95.0|0.85|2.67||||||Current user, case and matched control: Odds ratio (Lybrel/EE-20) and 95% CI were estimated using conditional logistic regression, conditional on matching factors (age, calendar time, exposure status and database).||2.67|0.85|
72551600|NCT01297348|144633489|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.53|||||TWO_SIDED|95.0|0.98|6.54||||||Current user, case and matched control: Odds ratio (Lybrel/Levo-20) and 95% CI were estimated using conditional logistic regression, conditional on matching factors (age, calendar time, exposure status and database).||6.54|0.98|
72551601|NCT01520909|144633490|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|17.96|||<|0.001|TWO_SIDED|95.0|2.29|140.93|||Cochran-Mantel-Haenszel|The proportion of participants achieving platelet counts \>=50 Gi/L for those participants receiving eltrombopag versus placebo was compared.||Indicated significance at the 5% (two-sided) level of significance||140.93|2.29|<0.001
72551602|NCT01520909|144633491|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|25.33|||<|0.001|TWO_SIDED|95.0|8.15|78.73|||Repeated measures model for binary data|Repeated measures model for binary data using Generalized linear mixed model||||78.73|8.15|<0.001
72551603|NCT01544127|144633541|SUPERIORITY||Odds Ratio (OR)|0.59|STANDARD_ERROR_OF_MEAN|0.19||0.054|TWO_SIDED|95.0|0.31|1.12||A priori, analyses were proposed to be one-sided, with p set at 0.05.|Zero-Inflated Poisson|Analysis adjusted for severity of worst TBI experience and used a robust standard error that was clustered on participants.|OR was calculated for number of participants with suicidal ideation. Analyses were one-sided, but two-sided confidence intervals for the OR are reported.|"MI-SI + TAU and MI-SI-R + TAU vs. TAU Alone~A hurdle model was used to examine the effect of the experimental interventions on the presence of suicidal ideation and the severity of suicidal ideation among those with it. These analyses examined the presence of suicidal ideation in the combined MI-SI + TAU and MI-SI-R + TAU treatment group."||1.12|0.31|.054
72551604|NCT01544127|144633541|SUPERIORITY||Odds Ratio (OR)|0.6|STANDARD_ERROR_OF_MEAN|0.26||0.12|TWO_SIDED|95.0|0.26|1.4||A priori, analyses were proposed as one-sided, with p set at 0.05.|Zero-Inflated Poisson|Analysis adjusted for severity of worst TBI experience and used a robust standard error that was clustered on participants.|OR was calculated for number of participants with suicidal ideation. Analyses were one-sided, but two-sided confidence intervals for the OR are reported.|MI-SI+TAU vs. TAU Alone||1.40|0.26|0.12
72551605|NCT01544127|144633541|SUPERIORITY||Odds Ratio (OR)|0.59|STANDARD_ERROR_OF_MEAN|0.22||0.08|TWO_SIDED|95.0|0.28|1.24||A priori, analyses were proposed as one-sided, with p set at 0.05.|Zero-Inflated Poisson|Analysis adjusted for severity of worst TBI experience and used a robust standard error that was clustered on participants.|OR was calculated for number of participants with suicidal ideation. Analyses were one-sided, but two-sided confidence intervals for the OR are reported.|MI-SI-R + TAU vs. TAU Alone||1.24|0.28|0.08
72551606|NCT01544127|144633542|SUPERIORITY||Beta|0.06|STANDARD_ERROR_OF_MEAN|0.11||0.3|TWO_SIDED|||||A priori, analyses were proposed to be one-sided, with p set at 0.05.|Zero-Inflated Poisson|A robust standard error clustered on participants was used.||"MI-SI + TAU vs. MI-SI-R + TAU vs. TAU Alone~A hurdle model was used to examine the effect of the experimental interventions on the presence/absence of suicidal ideation and the severity of suicidal ideation among those with it. These analyses examined the severity of suicidal ideation among participants with suicidal ideation in the combined MI-SI + TAU and MI-SI-R + TAU treatment group."||||0.30
72551607|NCT01544127|144633542|SUPERIORITY||Beta|0.09|STANDARD_ERROR_OF_MEAN|0.12||0.23|TWO_SIDED|||||A priori, analyses were proposed to be one-sided, with p set at 0.05.|Zero-Inflated Poisson|A robust standard error clustered on participants was used.||MI-SI vs. TAU Alone||||0.23
72551608|NCT01544127|144633542|SUPERIORITY||Beta|0.01|STANDARD_ERROR_OF_MEAN|0.13||0.46|TWO_SIDED|||||A priori, analyses were proposed to be one-sided, with p set at 0.05.|Zero-Inflated Poisson|A robust standard error clustered on participants was used.||MI-SI-R vs. TAU Alone||||0.46
72551609|NCT01544127|144633543|SUPERIORITY||Odds Ratio (OR)|1.03|STANDARD_ERROR_OF_MEAN|0.65||0.96|TWO_SIDED|0.95|0.3|3.54||A priori, p was set at 0.01 for multiple comparisons.|Regression, Logistic|||MI-SI + TAU vs. TAU Alone||3.54|0.30|0.96
72551610|NCT01544127|144633543|SUPERIORITY||Odds Ratio (OR)|0.68|STANDARD_ERROR_OF_MEAN|0.38||0.5|TWO_SIDED|95.0|0.23|2.06||A priori, p was set at 0.01 for multiple comparisons.|Regression, Logistic|||MI-SI-R + TAU vs. TAU Alone||2.06|0.23|0.50
72551611|NCT01544127|144633544|SUPERIORITY||Cox Proportional Hazard|1.69|STANDARD_ERROR_OF_MEAN|0.91||0.31|TWO_SIDED|95.0|0.59|4.88||A priori, p was set at 0.01 for multiple comparisons.|Log Rank|||MI-SI + TAU vs. TAU Alone||4.88|0.59|0.31
72551612|NCT01544127|144633544|SUPERIORITY||Cox Proportional Hazard|0.49|STANDARD_ERROR_OF_MEAN|0.39||0.24|TWO_SIDED|95.0|0.1|2.31||A priori, p was set at 0.01 for multiple comparisons.|Log Rank|||MI-SI-R vs. TAU Alone||2.31|0.10|0.24
72551613|NCT01544127|144633544|SUPERIORITY||Cox Proportional Hazard|0.29|STANDARD_ERROR_OF_MEAN|0.23||0.1|TWO_SIDED|95.0|0.06|1.43||A priori, p was set at 0.01 for multiple comparisons.|Log Rank|||"MI-SI-R + TAU vs. MI-SI + TAU~Because the impact of MI-SI + TAU and MI-SI-R + TAU were in different directions when compared to TAU Alone, they were compared. For this analysis, the null hypothesis was that the revisions did not change the impact of MI-SI + TAU."||1.43|0.06|0.10
72551614|NCT00533273|144633545|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<.001
72551615|NCT00533273|144633546|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<.001
72551616|NCT00533273|144633547|SUPERIORITY||||||<|0.001|||||||ANOVA|||||||<.001
72551617|NCT00533273|144633548|SUPERIORITY||||||<|0.001|||||||ANOVA|||||||<.001
72551618|NCT00533273|144633550|SUPERIORITY|||||||0.014|||||||Cochran-Mantel-Haenszel|||||||.014
72551619|NCT00533273|144633551|SUPERIORITY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<.0001
72551620|NCT00533273|144633552|SUPERIORITY||||||<|0.001|||||||ANOVA|||||||<.001
72551621|NCT00533273|144633553|SUPERIORITY||||||<|0.001|||||||ANOVA|||||||<.001
72551622|NCT02870920|144633563|SUPERIORITY||Hazard Ratio (HR)|0.72||||0.07|TWO_SIDED|90.0|0.54|0.97|||Log Rank|||||0.97|0.54|0.07
72551623|NCT02870920|144633564|SUPERIORITY||Hazard Ratio (HR)|1.01||||0.97|TWO_SIDED|90.0|0.76|1.34|||Log Rank|||||1.34|0.76|0.97
72551624|NCT00454909|144633575|SUPERIORITY||Difference in percentage|11.2|||||TWO_SIDED|95.0|3.87|19.18||||||Evaluation of the immunogenicity induced by Nimenrix™ conjugate vaccine as compared to Menactra® vaccine in terms of percentage of subjects with serum bactericidal assay using human complement against N. meningitidis serogroup A (hSBA-MenA) antibody titers ≥ 1:8 one month after vaccination.||19.18|3.87|
72551625|NCT00454909|144633575|SUPERIORITY||Difference in percentage|-2.77|||||TWO_SIDED|95.0|-5.08|0.4||||||Evaluation of the immunogenicity induced by Nimenrix™ conjugate vaccine as compared to Menactra® vaccine in terms of percentage of subjects with serum bactericidal assay using human complement against N. meningitidis serogroup C (hSBA-MenC) antibody titers ≥ 1:8 one month after vaccination.||0.40|-5.08|
72551626|NCT00454909|144633575|SUPERIORITY||Difference in percentage|14.93|||||TWO_SIDED|95.0|8.24|22.71||||||Evaluation of the immunogenicity induced by Nimenrix™ conjugate vaccine as compared to Menactra® vaccine in terms of percentage of subjects with serum bactericidal assay using human complement against N. meningitidis serogroup W-135 (hSBA-MenW -135) antibody titers ≥ 1:8 one month after vaccination.||22.71|8.24|
72551627|NCT00454909|144633575|SUPERIORITY||Difference in percentage|13.4|||||TWO_SIDED|95.0|7.9|20.1||||||Evaluation of the immunogenicity induced by Nimenrix™ conjugate vaccine as compared to Menactra® vaccine in terms of percentage of subjects with serum bactericidal assay using human complement against N. meningitidis serogroup Y (hSBA-MenY) antibody titers ≥ 1:8 one month after vaccination.||20.10|7.90|
72552972|NCT02481830|144637022|SUPERIORITY||Hazard Ratio (HR)|0.86||||0.1144|TWO_SIDED|95.0|0.72|1.04|||Log Rank||Stratified Cox proportional hazard model. Hazard Ratio is Nivolumab over Topotecan/Amrubicin|||1.04|0.72|0.1144
72551628|NCT00696020|144633622|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.024|STANDARD_ERROR_OF_MEAN|0.027||0.3791|TWO_SIDED|95.0|-0.029|0.076||Type I error was controlled by a closed stepwise procedure.|ANCOVA|terms for baseline, treatment, and centre (centre random, all other effects fixed).|2 µg Olodaterol + 5 µg Tiotropium minus 5 µg Tiotropium.|||0.076|-0.029|0.3791
72551629|NCT00696020|144633622|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.033|STANDARD_ERROR_OF_MEAN|0.027||0.2133|TWO_SIDED|95.0|-0.019|0.085||Type I error was controlled by a closed stepwise procedure.|ANCOVA|terms for baseline, treatment, and centre (centre random, all other effects fixed).|5 µg Olodaterol + 5 µg Tiotropium minus 5 µg Tiotropium.|||0.085|-0.019|0.2133
72551630|NCT00696020|144633622|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.057|STANDARD_ERROR_OF_MEAN|0.027||0.0337|TWO_SIDED|95.0|0.004|0.11||Type I error was controlled by a closed stepwise procedure.|ANCOVA|terms for baseline, treatment, and centre (centre random, all other effects fixed).|10 µg Olodaterol + 5 µg Tiotropium minus 5 µg Tiotropium.|||0.110|0.004|0.0337
72551631|NCT00696020|144633623|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.042|STANDARD_ERROR_OF_MEAN|0.026||0.1163|TWO_SIDED|95.0|-0.01|0.093||Type I error was controlled by a closed stepwise procedure.|ANCOVA|terms for baseline, treatment, and centre (centre random, all other effects fixed).|2 µg Olodaterol + 5 µg Tiotropium minus 5 µg Tiotropium.|||0.093|-0.010|0.1163
72551632|NCT00696020|144633623|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.06|STANDARD_ERROR_OF_MEAN|0.026||0.0224|TWO_SIDED|95.0|0.009|0.111||Type I error was controlled by a closed stepwise procedure.|ANCOVA|terms for baseline, treatment, and centre (centre random, all other effects fixed).|5 µg Olodaterol + 5 µg Tiotropium minus 5 µg Tiotropium.|||0.111|0.009|0.0224
72551633|NCT00696020|144633623|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.055|STANDARD_ERROR_OF_MEAN|0.026||0.038|TWO_SIDED|95.0|0.003|0.107||Type I error was controlled by a closed stepwise procedure.|ANCOVA|terms for baseline, treatment, and centre (centre random, all other effects fixed).|10 µg Olodaterol + 5 µg Tiotropium minus 5 µg Tiotropium.|||0.107|0.003|0.0380
72551634|NCT00696020|144633624|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.002|STANDARD_ERROR_OF_MEAN|0.047||0.9573|TWO_SIDED|95.0|-0.089|0.094|||ANCOVA|terms for baseline, treatment, centre (centre random, all other effects fixed).|2 µg Olodaterol + 5 µg Tiotropium minus 5 µg Tiotropium.|||0.094|-0.089|0.9573
72551635|NCT00696020|144633624|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.099|STANDARD_ERROR_OF_MEAN|0.046||0.0321|TWO_SIDED|95.0|0.009|0.189|||ANCOVA|terms for baseline, treatment, centre (centre random, all other effects fixed).|5 µg Olodaterol + 5 µg Tiotropium minus 5 µg Tiotropium.|||0.189|0.009|0.0321
72551636|NCT00696020|144633624|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.117|STANDARD_ERROR_OF_MEAN|0.047||0.0125|TWO_SIDED|95.0|0.025|0.209|||ANCOVA|terms for baseline, treatment, centre (centre random, all other effects fixed)|10 µg Olodaterol + 5 µg Tiotropium minus 5 µg Tiotropium.|||0.209|0.025|0.0125
72551637|NCT00696020|144633625|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.085|STANDARD_ERROR_OF_MEAN|0.03||0.0052|TWO_SIDED|95.0|0.026|0.145|||ANCOVA|terms for baseline, treatment, centre (centre random, all other effects fixed).|2 µg Olodaterol + 5 µg Tiotropium minus 5 µg Tiotropium.|||0.145|0.026|0.0052
72551638|NCT00696020|144633625|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.079|STANDARD_ERROR_OF_MEAN|0.03||0.0086|TWO_SIDED|95.0|0.02|0.138|||ANCOVA|terms for baseline, treatment, centre (centre random, all other effects fixed)|5 µg Olodaterol + 5 µg Tiotropium minus 5 µg Tiotropium.|||0.138|0.020|0.0086
72551639|NCT00696020|144633625|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.125|STANDARD_ERROR_OF_MEAN|0.03|<|0.0001|TWO_SIDED|95.0|0.066|0.185|||ANCOVA|terms for baseline, treatment, centre (centre random, all other effects fixed)|10 µg Olodaterol + 5 µg Tiotropium minus 5 µg Tiotropium.|||0.185|0.066|<0.0001
72552973|NCT02481830|144637023|SUPERIORITY||Hazard Ratio (HR)|1.39|||||TWO_SIDED|95.0|1.16|1.66|||||Hazard Ratio is Nivolumab over Topotecan/Amrubicin using Stratified Cox proportional hazard model|||1.66|1.16|
72551640|NCT00696020|144633626|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.116|STANDARD_ERROR_OF_MEAN|0.056||0.0384|TWO_SIDED|95.0|0.006|0.225|||ANCOVA|terms for baseline, treatment, centre (centre random, all other effects fixed)|2 µg Olodaterol + 5 µg Tiotropium minus 5 µg Tiotropium.|||0.225|0.006|0.0384
72551641|NCT00696020|144633626|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.184|STANDARD_ERROR_OF_MEAN|0.055||0.0009|TWO_SIDED|95.0|0.076|0.292|||ANCOVA|terms for baseline, treatment, centre (centre random, all other effects fixed).|5 µg Olodaterol + 5 µg Tiotropium minus 5 µg Tiotropium.|||0.292|0.076|0.0009
72551642|NCT00696020|144633626|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.239|STANDARD_ERROR_OF_MEAN|0.056|<|0.0001|TWO_SIDED|95.0|0.13|0.349|||ANCOVA|terms for baseline, treatment, centre (centre random, all other effects fixed)|10 µg Olodaterol + 5 µg Tiotropium minus 5 µg Tiotropium.|||0.349|0.130|<0.0001
72551643|NCT00696020|144633627|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|22.357|STANDARD_ERROR_OF_MEAN|6.76||0.001|TWO_SIDED|95.0|9.057|35.657|||ANCOVA|terms for baseline, treatment, centre (centre random, all other effects fixed).|2 µg Olodaterol + 5 µg Tiotropium minus 5 µg Tiotropium.|||35.657|9.057|0.0010
72584078|NCT00450437|144699073|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence lower limit was 0.5. If the lower limit of two sided 95% CIs for the ratio of the hSBA GMT (GMT for investigational vaccine / GMT for licensed vaccine) at one month following vaccination was above this limit, Investigational MenACWY vaccine would be non-inferior to Licensed MenACWY vaccine for Neisseria Meningitidis strain Y with respect to the immune response.|hSBA GMT ratios|2.49|||||TWO_SIDED|95.0|2.11|2.95|||ANOVA|||"Non-inferiority of Investigational MenACWY Vaccine vs. Licensed MenACWY vaccine, MenY.~The study would be considered a success if the lower limit of the two-sided 95% CIs for the hSBA GMT ratios comparing Investigational MenACWY vaccine to Licensed MenACWY vaccine for Neisseria Meningitidis strain Y at 1 month after vaccination was to be above 0.5."||2.95|2.11|
72584079|NCT00450437|144699075|NON_INFERIORITY_OR_EQUIVALENCE|Immunogenicity of the Investigational MenACWY vaccine would be considered non-inferior to that of the Licensed MenACWY vaccine if the lower limit of the two-sided CI for the between group difference (investigational vaccine minus licensed vaccine) in percentage of seroresponders one month after vaccination is \> -10%.|Vaccine group difference|-1.0|||||TWO_SIDED|95.0|-7.0|5.0|||ANOVA|||Vaccine group difference Investigational MenACWY vaccine vs. Licensed MenaCWY vaccine, MenA.||5|-7|
72584080|NCT00450437|144699075|NON_INFERIORITY_OR_EQUIVALENCE|Immunogenicity of the Investigational MenACWY vaccine would be considered non-inferior to that of the Licensed MenACWY vaccine if the lower limit of the two-sided CI for the between group difference (investigational vaccine minus licensed vaccine) in percentage of seroresponders one month after vaccination is \> -10%.|Vaccine group difference|9.0|||||TWO_SIDED|95.0|3.0|15.0|||ANOVA|||Vaccine group difference Investigational MenACWY vaccine vs. Licensed MenaCWY vaccine. MenC.||15|3|
72584081|NCT00450437|144699075|NON_INFERIORITY_OR_EQUIVALENCE|Immunogenicity of the Investigational MenACWY vaccine would be considered non-inferior to that of the Licensed MenACWY vaccine if the lower limit of the two-sided CI for the between group difference (investigational vaccine minus licensed vaccine) in percentage of seroresponders one month after vaccination is \> -10%.|Vaccine group difference|9.0|||||TWO_SIDED|95.0|2.0|17.0|||ANOVA|||Vaccine group difference Investigational MenACWY vaccine vs. Licensed MenaCWY vaccine, MenW.||17|2|
72584082|NCT00450437|144699075|NON_INFERIORITY_OR_EQUIVALENCE|Immunogenicity of the Investigational MenACWY vaccine would be considered non-inferior to that of the Licensed MenACWY vaccine if the lower limit of the two-sided CI for the between group difference (investigational vaccine minus licensed vaccine) in percentage of seroresponders one month after vaccination is \> -10%.|Vaccine group difference|16.0|||||TWO_SIDED|95.0|9.0|23.0|||ANOVA|||Vaccine group difference Investigational MenACWY vaccine vs. Licensed MenaCWY vaccine, MenY.||23|9|
72551644|NCT00696020|144633627|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|18.769|STANDARD_ERROR_OF_MEAN|6.687||0.0053|TWO_SIDED|95.0|5.613|31.924|||ANCOVA|terms for baseline, treatment, centre (centre random, all other effects fixed).|5 µg Olodaterol + 5 µg Tiotropium minus 5 µg Tiotropium.|||31.924|5.613|0.0053
72551645|NCT00696020|144633627|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|26.954|STANDARD_ERROR_OF_MEAN|6.805|<|0.0001|TWO_SIDED|95.0|13.565|40.343|||ANCOVA|terms for baseline, treatment, centre (centre random, all other effects fixed)|10 µg Olodaterol + 5 µg Tiotropium minus 5 µg Tiotropium.|||40.343|13.565|<0.0001
72551646|NCT00696020|144633628|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.088|STANDARD_ERROR_OF_MEAN|0.031||0.0048|TWO_SIDED|95.0|0.027|0.149|||ANCOVA|terms for baseline, treatment, and centre (centre random, all other effects fixed).|2 µg Olodaterol + 5 µg Tiotropium minus 5 µg Tiotropium.|||0.149|0.027|0.0048
72551647|NCT00696020|144633628|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.086|STANDARD_ERROR_OF_MEAN|0.031||0.0056|TWO_SIDED|95.0|0.025|0.146|||ANCOVA|terms for baseline, treatment, and centre (centre random, all other effects fixed).|5 µg Olodaterol + 5 µg Tiotropium minus 5 µg Tiotropium.|||0.146|0.025|0.0056
72551648|NCT00696020|144633628|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.128|STANDARD_ERROR_OF_MEAN|0.031|<|0.0001|TWO_SIDED|95.0|0.066|0.189|||ANCOVA|terms for baseline, treatment, and centre (centre random, all other effects fixed).|10 µg Olodaterol + 5 µg Tiotropium minus 5 µg Tiotropium.|||0.189|0.066|<0.0001
72551649|NCT00696020|144633629|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.12|STANDARD_ERROR_OF_MEAN|0.056||0.0332|TWO_SIDED|95.0|0.01|0.23|||ANCOVA|terms for baseline, treatment, centre (centre random, all other effects fixed).|2 µg Olodaterol + 5 µg Tiotropium minus 5 µg Tiotropium.|||0.230|0.010|0.0332
72551650|NCT00696020|144633629|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.183|STANDARD_ERROR_OF_MEAN|0.055||0.0011|TWO_SIDED|95.0|0.074|0.292|||ANCOVA|terms for baseline, treatment, centre (centre random, all other effects fixed)|5 µg Olodaterol + 5 µg Tiotropium minus 5 µg Tiotropium.|||0.292|0.074|0.0011
72551651|NCT00696020|144633629|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.238|STANDARD_ERROR_OF_MEAN|0.056|<|0.0001|TWO_SIDED|95.0|0.128|0.349|||ANCOVA|terms for baseline, treatment, centre (centre random, all other effects fixed)|10 µg Olodaterol + 5 µg Tiotropium minus 5 µg Tiotropium.|||0.349|0.128|<0.0001
72551652|NCT00696020|144633630|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|22.867|STANDARD_ERROR_OF_MEAN|6.813||0.0009|TWO_SIDED|95.0|9.462|36.272|||ANCOVA|terms for baseline, treatment, centre (centre random, all other effects fixed).|2 µg Olodaterol + 5 µg Tiotropium minus 5 µg Tiotropium.|||36.272|9.462|0.0009
72551653|NCT00696020|144633630|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|19.743|STANDARD_ERROR_OF_MEAN|6.739||0.0036|TWO_SIDED|95.0|6.484|33.002|||ANCOVA|terms for baseline, treatment, centre (centre random, all other effects fixed)|5 µg Olodaterol + 5 µg Tiotropium minus 5 µg Tiotropium.|||33.002|6.484|0.0036
72551654|NCT00696020|144633630|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|27.793|STANDARD_ERROR_OF_MEAN|6.859|<|0.0001|TWO_SIDED|95.0|14.298|41.287|||ANCOVA|terms for baseline, treatment, centre (centre random, all other effects fixed)|10 µg Olodaterol + 5 µg Tiotropium minus 5 µg Tiotropium.|||41.287|14.298|<0.0001
72551655|NCT00696020|144633631|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.088|STANDARD_ERROR_OF_MEAN|0.033||0.0079|TWO_SIDED|95.0|0.023|0.152|||ANCOVA|terms for baseline, treatment, centre (centre random, all other effects fixed)|2 µg Olodaterol + 5 µg Tiotropium minus 5 µg Tiotropium.|||0.152|0.023|0.0079
72551656|NCT00696020|144633631|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.082|STANDARD_ERROR_OF_MEAN|0.032||0.012|TWO_SIDED|95.0|0.018|0.146|||ANCOVA|terms for baseline, treatment, centre (centre random, all other effects fixed)|5 µg Olodaterol + 5 µg Tiotropium minus 5 µg Tiotropium.|||0.146|0.018|0.0120
72551657|NCT00696020|144633631|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.144|STANDARD_ERROR_OF_MEAN|0.033|<|0.0001|TWO_SIDED|95.0|0.08|0.209|||ANCOVA|terms for baseline, treatment, centre (centre random, all other effects fixed)|10 µg Olodaterol + 5 µg Tiotropium minus 5 µg Tiotropium.|||0.209|0.080|<0.0001
72551658|NCT00696020|144633632|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.131|STANDARD_ERROR_OF_MEAN|0.06||0.0296|TWO_SIDED|95.0|0.013|0.249|||ANCOVA|terms for baseline, treatment, centre (centre random, all other effects fixed)|2 µg Olodaterol + 5 µg Tiotropium minus 5 µg Tiotropium.|||0.249|0.013|0.0296
72551659|NCT00696020|144633632|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.204|STANDARD_ERROR_OF_MEAN|0.059||0.0007|TWO_SIDED|95.0|0.087|0.32|||ANCOVA|terms for baseline, treatment, centre (centre random, all other effects fixed)|5 µg Olodaterol + 5 µg Tiotropium minus 5 µg Tiotropium.|||0.320|0.087|0.0007
72551660|NCT00696020|144633632|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.265|STANDARD_ERROR_OF_MEAN|0.06|<|0.0001|TWO_SIDED|95.0|0.147|0.383|||ANCOVA|terms for baseline, treatment, centre (centre random, all other effects fixed)|10 µg Olodaterol + 5 µg Tiotropium minus 5 µg Tiotropium.|||0.383|0.147|<0.0001
72551661|NCT00696020|144633633|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|23.414|STANDARD_ERROR_OF_MEAN|7.057||0.001|TWO_SIDED|95.0|9.529|37.3|||ANCOVA|terms for baseline, treatment, centre (centre random, all other effects fixed).|2 µg Olodaterol + 5 µg Tiotropium minus 5 µg Tiotropium.|||37.300|9.529|0.0010
72552974|NCT02481830|144637024|SUPERIORITY||Estimate of Odds Ratio (OR)|0.78|||||TWO_SIDED|95.0|0.49|1.24|||||Strata adjusted odds ratio (Nivolumab over Topotecan/Amrubicin) using Mantel-Haenszel method|||1.24|0.49|
72551662|NCT00696020|144633633|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|18.695|STANDARD_ERROR_OF_MEAN|6.981||0.0078|TWO_SIDED|95.0|4.961|32.43|||ANCOVA|terms for baseline, treatment, centre (centre random, all other effects fixed).|5 µg Olodaterol + 5 µg Tiotropium minus 5 µg Tiotropium.|||32.430|4.961|0.0078
72551663|NCT00696020|144633633|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|29.357|STANDARD_ERROR_OF_MEAN|7.105|<|0.0001|TWO_SIDED|95.0|15.379|43.335|||ANCOVA|terms for baseline, treatment, centre (centre random, all other effects fixed)|10 µg Olodaterol + 5 µg Tiotropium minus 5 µg Tiotropium.|||43.335|15.379|<0.0001
72551664|NCT00696020|144633635|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.044|STANDARD_ERROR_OF_MEAN|0.048||0.3517|TWO_SIDED|95.0|-0.049|0.138|||ANCOVA|terms for baseline, treatment, centre (centre random, all other effects fixed).|2 µg Olodaterol + 5 µg Tiotropium minus 5 µg Tiotropium.|||0.138|-0.049|0.3517
72551665|NCT00696020|144633635|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.048|STANDARD_ERROR_OF_MEAN|0.048||0.3171|TWO_SIDED|95.0|-0.046|0.143|||ANCOVA|terms for baseline, treatment, centre (centre random, all other effects fixed)|5 µg Olodaterol + 5 µg Tiotropium minus 5 µg Tiotropium.|||0.143|-0.046|0.3171
72551666|NCT00696020|144633635|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.035|STANDARD_ERROR_OF_MEAN|0.048||0.4654|TWO_SIDED|95.0|-0.06|0.13|||ANCOVA|terms for baseline, treatment, centre (centre random, all other effects fixed)|10 µg Olodaterol + 5 µg Tiotropium minus 5 µg Tiotropium.|||0.130|-0.060|0.4654
72551667|NCT00696020|144633636|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.106|STANDARD_ERROR_OF_MEAN|7.704||0.0899|TWO_SIDED|95.0|-2.055|28.267|||ANCOVA|terms for baseline, treatment, centre (centre random, all other effects fixed).|2 µg Olodaterol + 5 µg Tiotropium minus 5 µg Tiotropium.|||28.267|-2.055|0.0899
72551668|NCT00696020|144633636|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|19.817|STANDARD_ERROR_OF_MEAN|7.759||0.0111|TWO_SIDED|95.0|4.549|35.084|||ANCOVA|terms for baseline, treatment, centre (centre random, all other effects fixed).|5 µg Olodaterol + 5 µg Tiotropium minus 5 µg Tiotropium.|||35.084|4.549|0.0111
72551669|NCT00696020|144633636|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|18.893|STANDARD_ERROR_OF_MEAN|7.844||0.0166|TWO_SIDED|95.0|3.458|34.329|||ANCOVA|terms for baseline, treatment, centre (centre random, all other effects fixed)|10 µg Olodaterol + 5 µg Tiotropium minus 5 µg Tiotropium.|||34.329|3.458|0.0166
72551670|NCT01387022|144633649|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||||||1.00
72551671|NCT01387022|144633650|SUPERIORITY_OR_OTHER|||||||0.481|||||||Wilcoxon (Mann-Whitney)|||||||0.481
72551672|NCT01387022|144633652|SUPERIORITY_OR_OTHER|||||||0.267|||||||Fisher Exact|||||||0.267
72551673|NCT01371786|144633663|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.92|||||TWO_SIDED|95.0|-21.76|-4.09||No formal statistical testing was conducted. Only descriptive statistics were calculated and presented.|||Difference calculated as Mometasone minus Ciclesonide|No formal null hypothesis was stated or tested.Descriptive statistics only were calculated and presented. The sample size was determined outside of statistical considerations. The sample size of 10 subjects was sufficient to provide approximately 80% power to detect a difference of 25% between the two treatment groups in the percentage of nasal deposition approximately 2 minutes post dose, assuming a two-sided test evaluated at a significance level of 0.05, with a SD of the difference of 23.17%.||-4.09|-21.76|
72551674|NCT02549092|144633668|SUPERIORITY||Least Squares (LS) Mean of Difference|-8.21|STANDARD_ERROR_OF_MEAN|9.91||0.41|TWO_SIDED|95.0|-27.98|11.55||P value is from the mixed model repeated measures (MMRM) with the model: change from Baseline=treatment, country, visit, Baseline, treatment-by-visit, and Baseline-by-visit. Unstructured variance-covariance structure was used in the MMRM analysis.|mixed model repeated measures|Adjusted for multiplicity using the Hochberg procedure to control the family-wise error rate at a pre-specified significance level (alpha = 0.05).|Difference of LCIG - OMT|||11.55|-27.98|0.410
72551675|NCT02549092|144633669|SUPERIORITY||LS Mean of Difference|1.57|STANDARD_ERROR_OF_MEAN|2.37||0.509|TWO_SIDED|95.0|-3.16|6.3||The P value is from the MMRM with the model: change from Baseline = treatment, country, visit, Baseline, treatment-by-visit, and Baseline-by-visit. The unstructured variance-covariance structure was used in the MMRM analysis.|mixed model repeated measures|Adjusted for multiplicity using the Hochberg procedure to control the family-wise error rate at a pre-specified significance level (alpha = 0.05).|Difference of LCIG - OMT|||6.30|-3.16|0.509
72551676|NCT02549092|144633670|SUPERIORITY||LS mean difference|-3.81|STANDARD_ERROR_OF_MEAN|3.59||0.291|TWO_SIDED|95.0|-10.96|3.34||The repeated measures model: change = treatment, country, visit, baseline, treatment \* visit, baseline \* visit. The unstructured variance-covariance structure is used.|Repeated measures model||Difference of LCIG - OMT|Statistical significance for the 3 key secondary efficacy endpoints (PDQ-8 index score, CGI-C score, and UPDRS Part II) could only be evaluated using the Hochberg procedure for multiplicity control if both primary endpoints had been statistically significant after multiplicity adjustment.||3.34|-10.96|0.291
72551677|NCT02549092|144633671|SUPERIORITY||LS Mean of Difference|-2.3|STANDARD_ERROR_OF_MEAN|0.26|<|0.001|TWO_SIDED|95.0|-2.84|-1.82||Analysis of covariance (ANCOVA) model: FINAL = treatment, country.|ANCOVA||Difference of LCIG - OMT|Statistical significance for the 3 key secondary efficacy endpoints (PDQ-8 index score, CGI-C score, and UPDRS Part II) could only be evaluated using the Hochberg procedure for multiplicity control if both primary endpoints had been statistically significant after multiplicity adjustment.||-1.82|-2.84|< 0.001
72552975|NCT02481830|144637025|SUPERIORITY||Hazard Ratio (HR)|0.87|||||TWO_SIDED|95.0|0.73|1.04|||||Stratified Cox proportional hazard model. Hazard Ratio is Nivolumab over Topotecan/Amrubicin|||1.04|0.73|
72552976|NCT04627038|144637026|SUPERIORITY||Posterior Mean Difference|0.09|||||TWO_SIDED|95.0|-0.51|0.67|||||Posterior mean difference with 95% credible interval is reported.|||0.67|-0.51|
72552977|NCT04627038|144637027|SUPERIORITY||Posterior Mean Difference|0.95|||||TWO_SIDED|95.0|-0.07|1.96|||||Posterior mean difference with 95% credible interval is reported.|||1.96|-0.07|
72552978|NCT04627038|144637028|SUPERIORITY||Posterior Mean Difference|0.24|||||TWO_SIDED|95.0|-0.24|0.72|||||Posterior mean difference with 95% credible interval is reported.|||0.72|-0.24|
72552979|NCT04627038|144637029|SUPERIORITY||Posterior Mean Difference|3.84|||||TWO_SIDED|95.0|0.39|7.2|||||Posterior mean difference with 95% credible interval is reported.|||7.20|0.39|
72552980|NCT04627038|144637030|SUPERIORITY||Posterior Mean Difference|-0.1|||||TWO_SIDED|95.0|-0.48|0.28|||||Posterior mean difference with 95% credible interval is reported.|||0.28|-0.48|
72552981|NCT04627038|144637031|SUPERIORITY||Posterior Mean Difference|0.31|||||TWO_SIDED|95.0|-0.32|0.95|||||Posterior mean difference with 95% credible interval is reported.|||0.95|-0.32|
72552982|NCT04627038|144637032|SUPERIORITY||Posterior Mean Difference|6.24|||||TWO_SIDED|95.0|-1.05|13.56|||||Posterior mean difference with 95% credible interval is reported.|||13.56|-1.05|
72552983|NCT04627038|144637033|SUPERIORITY||Posterior Mean Difference|0.16|||||TWO_SIDED|95.0|-0.14|0.46|||||Posterior mean difference with 95% credible interval is reported.|||0.46|-0.14|
72552984|NCT04627038|144637034|SUPERIORITY||Posterior Mean Difference|-0.82|||||TWO_SIDED|95.0|-166.74|165.52|||||Posterior mean difference with 95% credible interval is reported.|||165.52|-166.74|
72413149|NCT02528214|144334946|SUPERIORITY|Testing was performed according to the hierarchical testing procedure (continued only if previous endpoints were statistically significant).|Odds Ratio (OR)|4.48|||<|0.0001|TWO_SIDED|95.0|2.39|8.39||Threshold for significance at 0.05.|Regression, Logistic||Dupilumab 300 mg q2w v Placebo q2w|The outcome measure was analyzed using a logistic regression model. The model included the binary status of whether or not a participant achieved a reduction of OCS dose to \<5 mg/day at Week 24 as the response variable, treatment groups, optimized OCS dose at baseline, regions, and baseline eosinophil level subgroups as covariates. Missing data was imputed by using a pattern mixture model by multiple imputation approach.||8.39|2.39|< 0.0001
72551678|NCT02549092|144633672|SUPERIORITY||LS mean difference|-2.79|STANDARD_ERROR_OF_MEAN|0.99||0.006|TWO_SIDED|95.0|-4.77|-0.81||The repeated measures model: change = treatment, country, visit, baseline, treatment \* visit, baseline \* visit. The unstructured variance-covariance structure is used.|Repeated measures model||Difference of LCIG - OMT|Statistical significance for the 3 key secondary efficacy endpoints (PDQ-8 index score, CGI-C score, and UPDRS Part II) could only be evaluated using the Hochberg procedure for multiplicity control if both primary endpoints had been statistically significant after multiplicity adjustment.||-0.81|-4.77|0.006
72551679|NCT02549092|144633673|SUPERIORITY||LS mean difference|0.08|STANDARD_ERROR_OF_MEAN|0.99||0.933|TWO_SIDED|95.0|-1.89|2.06||The repeated measures model: change = treatment, country, visit, baseline, treatment \* visit, baseline \* visit. The unstructured variance-covariance structure is used.|Repeated measures model||Difference of LCIG - OMT|Cardiovascular including falls||2.06|-1.89|0.933
72551680|NCT02549092|144633673|SUPERIORITY||LS mean difference|1.05|STANDARD_ERROR_OF_MEAN|2.35||0.655|TWO_SIDED|95.0|-3.63|5.74||The repeated measures model: change = treatment, country, visit, baseline, treatment \* visit, baseline \* visit. The unstructured variance-covariance structure is used.|Repeated measures model||Difference of LCIG - OMT|Sleep/fatigue||5.74|-3.63|0.655
72551681|NCT02549092|144633673|SUPERIORITY||LS mean difference|-1.85|STANDARD_ERROR_OF_MEAN|3.67||0.616|TWO_SIDED|95.0|-9.18|5.48||The repeated measures model: change = treatment, country, visit, baseline, treatment \* visit, baseline \* visit. The unstructured variance-covariance structure is used.|Repeated measures model||Difference of LCIG - OMT|Mood/cognition||5.48|-9.18|0.616
72551682|NCT02549092|144633673|SUPERIORITY||LS mean difference|0.39|STANDARD_ERROR_OF_MEAN|0.84||0.645|TWO_SIDED|95.0|-1.3|2.08||The repeated measures model: change = treatment, country, visit, baseline, treatment \* visit, baseline \* visit. The unstructured variance-covariance structure is used.|Repeated measures model||Difference of LCIG - OMT|Perceptual problems/hallucinations||2.08|-1.30|0.645
72551683|NCT02549092|144633673|SUPERIORITY||LS mean difference|-0.94|STANDARD_ERROR_OF_MEAN|2.04||0.645|TWO_SIDED|95.0|-5.03|3.14||The repeated measures model: change = treatment, country, visit, baseline, treatment \* visit, baseline \* visit. The unstructured variance-covariance structure is used.|Repeated measures model||Difference of LCIG - OMT|Attention/memory||3.14|-5.03|0.645
72551684|NCT02549092|144633673|SUPERIORITY||LS mean difference|-2.58|STANDARD_ERROR_OF_MEAN|1.34||0.058|TWO_SIDED|95.0|-5.25|0.09||The repeated measures model: change = treatment, country, visit, baseline, treatment \* visit, baseline \* visit. The unstructured variance-covariance structure is used.|Repeated measures model||Difference of LCIG - OMT|Gastrointestinal tract||0.09|-5.25|0.058
72551685|NCT02549092|144633673|SUPERIORITY||LS mean difference|-1.18|STANDARD_ERROR_OF_MEAN|2.17||0.588|TWO_SIDED|95.0|-5.52|3.15||The repeated measures model: change = treatment, country, visit, baseline, treatment \* visit, baseline \* visit. The unstructured variance-covariance structure is used.|Repeated measures model||Difference of LCIG - OMT|Urinary||3.15|-5.52|0.588
72551686|NCT02549092|144633673|SUPERIORITY||LS mean difference|-0.78|STANDARD_ERROR_OF_MEAN|1.05||0.464|TWO_SIDED|95.0|-2.88|1.33||The repeated measures model: change = treatment, country, visit, baseline, treatment \* visit, baseline \* visit. The unstructured variance-covariance structure is used.|Repeated measures model||Difference of LCIG - OMT|Sexual function||1.33|-2.88|0.464
72551687|NCT02549092|144633673|SUPERIORITY||LS mean difference|-1.29|STANDARD_ERROR_OF_MEAN|1.76||0.468|TWO_SIDED|95.0|-4.8|2.23||The repeated measures model: change = treatment, country, visit, baseline, treatment \* visit, baseline \* visit. The unstructured variance-covariance structure is used.|Repeated measures model||Difference of LCIG - OMT|Miscellaneous||2.23|-4.80|0.468
72551688|NCT02549092|144633674|SUPERIORITY||LS Mean of Difference|-0.58|STANDARD_ERROR_OF_MEAN|1.26||0.643|TWO_SIDED|95.0|-3.09|1.92||The repeated measures model: change = treatment, country, visit, baseline, treatment \* visit, baseline \* visit. The unstructured variance-covariance structure is used.|repeated measures model||Difference of LCIG - OMT|Motor symptoms at night||1.92|-3.09|0.643
72551689|NCT02549092|144633674|SUPERIORITY||LS Mean of Difference|0.24|STANDARD_ERROR_OF_MEAN|0.82||0.769|TWO_SIDED|95.0|-1.39|1.87||The repeated measures model: change = treatment, country, visit, baseline, treatment \* visit, baseline \* visit. The unstructured variance-covariance structure is used.|repeated measures model||Difference of LCIG - OMT|PD symptoms at night||1.87|-1.39|0.769
72551690|NCT02549092|144633674|SUPERIORITY||LS Mean of Difference|1.99|STANDARD_ERROR_OF_MEAN|0.84||0.02|TWO_SIDED|95.0|0.32|3.66||The repeated measures model: change = treatment, country, visit, baseline, treatment \* visit, baseline \* visit. The unstructured variance-covariance structure is used.|repeated measures model||Difference of LCIG - OMT|Disturbed sleep||3.66|0.32|0.020
72551691|NCT02549092|144633675|SUPERIORITY||LS Mean of Difference|0.19|STANDARD_ERROR_OF_MEAN|0.46||0.672|TWO_SIDED|95.0|-0.72|1.1||The repeated measures model: change = treatment, country, visit, baseline, treatment \* visit, baseline \* visit. The unstructured variance-covariance structure is used.|repeated measures model||Difference of LCIG - OMT|Part I score||1.10|-0.72|0.672
72551692|NCT02549092|144633675|SUPERIORITY||LS Mean of Difference|-2.22|STANDARD_ERROR_OF_MEAN|2.13||0.302|TWO_SIDED|95.0|-6.47|2.04||The repeated measures model: change = treatment, country, visit, baseline, treatment \* visit, baseline \* visit. The unstructured variance-covariance structure is used.|repeated measures model||Difference of LCIG - OMT|Part III score||2.04|-6.47|0.302
72552985|NCT04627038|144637035|SUPERIORITY||Posterior Mean Difference|-0.02|||||TWO_SIDED|95.0|-0.09|0.06|||||Posterior mean difference with 95% credible interval is reported.|||0.06|-0.09|
72552986|NCT02255097|144637036|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||exact binomial distribution|null hypothesis (H0): p ≤ 0.05 versus alternate hypothesis (H1): p \> 0.05||Analysis comparing the ORR for pembrolizumab to a fixed efficacy target of 5% using an exact test of binomial distribution||||<0.001
72551693|NCT02549092|144633675|SUPERIORITY||LS Mean of Difference|-1.7|STANDARD_ERROR_OF_MEAN|0.61||0.007|TWO_SIDED|95.0|-2.91|-0.48||The repeated measures model: change = treatment, country, visit, baseline, treatment \* visit, baseline \* visit. The unstructured variance-covariance structure is used.|repeated measures model||Difference of LCIG - OMT|Part IV score||-0.48|-2.91|0.007
72551694|NCT02549092|144633676|SUPERIORITY||LS Mean of Difference|-1.54|STANDARD_ERROR_OF_MEAN|1.5||0.307|TWO_SIDED|95.0|-4.52|1.44||The repeated measures model: change = treatment, country, visit, baseline, treatment \* visit, baseline \* visit. The unstructured variance-covariance structure is used.|repeated measures model||Difference of LCIG - OMT|||1.44|-4.52|0.307
72551695|NCT02549092|144633677|SUPERIORITY||LS Mean of Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.46||0.868|TWO_SIDED|95.0|-0.99|0.84||The repeated measures model: change = treatment, country, visit, baseline, treatment \* visit, baseline \* visit. The unstructured variance-covariance structure is used.|repeated measures model||Difference of LCIG - OMT|||0.84|-0.99|0.868
72551696|NCT02549092|144633678|SUPERIORITY||LS Mean of Difference|-1.14|STANDARD_ERROR_OF_MEAN|3.28||0.728|TWO_SIDED|95.0|-7.68|5.39||The repeated measures model: change = treatment, country, visit, baseline, treatment \* visit, baseline \* visit. The unstructured variance-covariance structure is used.|repeated measures model||Difference of LCIG - OMT|Total score||5.39|-7.68|0.728
72551697|NCT02549092|144633678|SUPERIORITY||LS Mean of Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.71||0.916|TWO_SIDED|95.0|-1.5|1.35||The repeated measures model: change = treatment, country, visit, baseline, treatment \* visit, baseline \* visit. The unstructured variance-covariance structure is used.|repeated measures model||Difference of LCIG - OMT|Musculoskeletal pain score||1.35|-1.50|0.916
72551698|NCT02549092|144633678|SUPERIORITY||LS Mean of Difference|0.07|STANDARD_ERROR_OF_MEAN|0.68||0.919|TWO_SIDED|95.0|-1.28|1.42||The repeated measures model: change = treatment, country, visit, baseline, treatment \* visit, baseline \* visit. The unstructured variance-covariance structure is used.|repeated measures model||Difference of LCIG - OMT|Chronic pain score||1.42|-1.28|0.919
72551699|NCT02549092|144633678|SUPERIORITY||LS Mean of Difference|0.63|STANDARD_ERROR_OF_MEAN|1.53||0.68|TWO_SIDED|95.0|-2.42|3.68||The repeated measures model: change = treatment, country, visit, baseline, treatment \* visit, baseline \* visit. The unstructured variance-covariance structure is used.|repeated measures model||Difference of LCIG - OMT|Fluctuation related pain score||3.68|-2.42|0.680
72551700|NCT02549092|144633678|SUPERIORITY||LS Mean of Difference|-0.37|STANDARD_ERROR_OF_MEAN|1.24||0.767|TWO_SIDED|95.0|-2.83|2.09||The repeated measures model: change = treatment, country, visit, baseline, treatment \* visit, baseline \* visit. The unstructured variance-covariance structure is used.|repeated measures model||Difference of LCIG - OMT|Nocturnal pain score||2.09|-2.83|0.767
72551701|NCT02549092|144633678|SUPERIORITY||LS Mean of Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.51||0.804|TWO_SIDED|95.0|-1.15|0.9||The repeated measures model: change = treatment, country, visit, baseline, treatment \* visit, baseline \* visit. The unstructured variance-covariance structure is used.|repeated measures model||Difference of LCIG - OMT|Orofacial pain score||0.90|-1.15|0.804
72551702|NCT02549092|144633678|SUPERIORITY||LS Mean of Difference|-1.81|STANDARD_ERROR_OF_MEAN|0.79||0.025|TWO_SIDED|95.0|-3.38|-0.23||The repeated measures model: change = treatment, country, visit, baseline, treatment \* visit, baseline \* visit. The unstructured variance-covariance structure is used.|repeated measures model||Difference of LCIG - OMT|Discoloration and edema score||-0.23|-3.38|0.025
72551703|NCT02549092|144633678|SUPERIORITY||LS Mean of Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.47||0.93|TWO_SIDED|95.0|-0.99|0.9||The repeated measures model: change = treatment, country, visit, baseline, treatment \* visit, baseline \* visit. The unstructured variance-covariance structure is used.|repeated measures model||Difference of LCIG - OMT|Radicular pain score||0.90|-0.99|0.930
72551704|NCT02549092|144633679|SUPERIORITY||LS Mean of Difference|-2.4|STANDARD_ERROR_OF_MEAN|0.26|<|0.001|TWO_SIDED|95.0|-2.89|-1.87||ANCOVA model: FINAL = treatment, country.|ANCOVA||Difference of LCIG - OMT|||-1.87|-2.89|< 0.001
72551705|NCT02511782|144633682|SUPERIORITY_OR_OTHER||||||<|0.01|||||||t-test, 2 sided|||||||<0.01
72551706|NCT02511782|144633683|SUPERIORITY_OR_OTHER||||||<|0.01|||||||t-test, 2 sided|||||||<0.01
72551707|NCT02495467|144633697|SUPERIORITY||Mean Difference (Final Values)|1.03||||0.0132|TWO_SIDED|95.0|0.22|1.84|||Mixed Models Analysis|||||1.84|0.22|0.0132
72551708|NCT02495467|144633698|SUPERIORITY||Mean Difference (Final Values)|0.41||||0.0122|TWO_SIDED|95.0|0.09|0.73|||Mixed Models Analysis|||||0.73|0.09|0.0122
72551709|NCT02495467|144633699|SUPERIORITY||Mean Difference (Final Values)|0.39|||<|0.0001|TWO_SIDED|95.0|0.21|0.57|||Mixed Models Analysis|||||0.57|0.21|<0.0001
72551710|NCT02495467|144633700|SUPERIORITY||Mean Difference (Final Values)|0.41||||0.0055|TWO_SIDED|95.0|0.12|0.69|||Mixed Models Analysis|||||0.69|0.12|0.0055
72551711|NCT02495467|144633701|SUPERIORITY||Mean Difference (Final Values)|0.48||||0.001|TWO_SIDED|95.0|0.2|0.76|||Mixed Models Analysis|||||0.76|0.20|0.001
72551712|NCT02495467|144633702|SUPERIORITY||Means ratio|0.995||||0.7999|TWO_SIDED|95.0|0.96|1.032|||Generalized Linear Mixed Model|||||1.032|0.960|0.7999
72551713|NCT02495467|144633703|SUPERIORITY||Means ratio|0.989||||0.6746|TWO_SIDED|95.0|0.937|1.043|||Generalized Linear Mixed Model|||||1.043|0.937|0.6746
72551714|NCT02495467|144633704|SUPERIORITY||Means ratio|1.075||||0.0959|TWO_SIDED|95.0|0.987|1.17|||Generalized Linear Mixed Model|||||1.170|0.987|0.0959
72551715|NCT02495467|144633705|SUPERIORITY||Means ratio|1.522|||<|0.0001|TWO_SIDED|95.0|1.267|1.829|||Generalized Linear Mixed Model|||||1.829|1.267|<0.0001
72551716|NCT02495467|144633706|SUPERIORITY||Means ratio|1.32||||0.0005|TWO_SIDED|95.0|1.128|1.545|||Generalized Linear Mixed Model|||||1.545|1.128|0.0005
72551717|NCT02495467|144633707|SUPERIORITY||||||<|0.0001|||||||Prescott Test (Exact)|||||||<0.0001
72551718|NCT02495467|144633708|SUPERIORITY|||||||0.0003|||||||Prescott Test (Exact)|||||||0.0003
72551719|NCT01376167|144633709|SUPERIORITY||Hazard Ratio (HR)|0.299|||<|0.001|TWO_SIDED|95.0|0.222|0.404||The Cox proportional hazards model was fitted with region and treatment as covariates.|Cox Proportional Hazards Model||A hazard ratio\<1 indicated a lower chance of relapse compared to CQ only.|||0.404|0.222|<0.001
72551720|NCT01376167|144633709|SUPERIORITY||Hazard Ratio (HR)|0.262|||<|0.001|TWO_SIDED|95.0|0.178|0.387||The Cox proportional hazards model was fitted with region and treatment as covariates.|Cox Proportional Hazards Model||A hazard ratio\<1 indicated a lower chance of relapse compared to CQ only.|||0.387|0.178|<0.001
72551721|NCT01376167|144633709|SUPERIORITY||Odds Ratio (OR)|0.241|||<|0.001|TWO_SIDED|95.0|0.152|0.382||Logistic regression model was fitted with region and treatment as covariates. Participants with a zero P vivax asexual parasite count at Baseline were excluded from the analysis.|Regression, Logistic||Odds ratios \< 1 suggested a smaller chance of recurrence compared to CQ Only.|||0.382|0.152|<0.001
72551722|NCT01376167|144633709|SUPERIORITY||Odds Ratio (OR)|0.198|||<|0.001|TWO_SIDED|95.0|0.117|0.335||Logistic regression model was fitted with region and treatment as covariates. Participants with a zero P vivax asexual parasite count at Baseline were excluded from the analysis.|Regression, Logistic||Odds ratios \< 1 suggested a smaller chance of recurrence compared to CQ Only.|||0.335|0.117|<0.001
72551723|NCT01376167|144633710|SUPERIORITY||Hazard Ratio (HR)|0.271|||<|0.001|TWO_SIDED|95.0|0.195|0.376||The Cox proportional hazards model was fitted with region and treatment as covariates.|Cox Proportional Hazards Model||A hazard ratio\<1 indicated a lower chance of relapse compared to CQ only.|||0.376|0.195|<0.001
72551724|NCT01376167|144633710|SUPERIORITY||Hazard Ratio (HR)|0.255|||<|0.001|TWO_SIDED|95.0|0.167|0.39||The Cox proportional hazards model was fitted with region and treatment as covariates.|Cox Proportional Hazards Model||A hazard ratio\<1 indicated a lower chance of relapse compared to CQ only.|||0.390|0.167|<0.001
72551725|NCT00678639|144633751|SUPERIORITY_OR_OTHER||Median cost difference|588.0|||||TWO_SIDED|95.0|336.0|811.0|||Hodges-Lehmann (median cost difference)|Distribution-free 95% CIs calculated using the method of Moses.|Results favored a reduced cost in the OU-CMR group.|H0: The median costs are not different among the study groups. HA: The median cost is different among groups. Power calculation was based on detecting a mean cost difference of $2000. Data was found to be non-normally distributed and therefore nonparametric comparisons were implemented.||811|336|
72551726|NCT00678639|144633752|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Fisher Exact|||"H0: There is no difference in correct cardiovascular admission decisions among groups.~Ha: A difference exists among study groups. Sample size was based upon 47 analyzable participants per study arm were required to provide 88% power to detect a 30% difference in the outcome."||||<0.001
72551727|NCT03611608|144633756|SUPERIORITY||Mean Difference (Final Values)|263.54|||<|0.001|ONE_SIDED|90.0|207.86||||t-test, 1 sided||||||207.86|<0.001
72551728|NCT00986245|144633760|NON_INFERIORITY_OR_EQUIVALENCE|80% power|Mean Difference (Net)|0.4|||<|0.05|||||||Sign test|||The UPDRS-part3 was compared between the Once-daily of Ropinirole PR arm and the Twice-daily of Ropinirole PR using the Wilcoxon signed rank test.||||<0.05
72551729|NCT00986245|144633761|NON_INFERIORITY_OR_EQUIVALENCE|80% power|Mean Difference (Net)|0.0|||<|0.05|||||||Sign test|||The Hoehn and Yahr stage was compared between the Once-daily of Ropinirole PR arm and the Twice-daily of Ropinirole PR using the Wilcoxon signed rank test.||||<0.05
72551730|NCT00986245|144633762|NON_INFERIORITY_OR_EQUIVALENCE|80% power|Mean Difference (Net)|0.3|||<|0.05|||||||Sign test|||"The Overall quality of sleep was compared between the Once-daily of Ropinirole PR arm and the Twice-daily of Ropinirole PR using the Wilcoxon signed rank test."||||<0.05
72551731|NCT00986245|144633763|NON_INFERIORITY_OR_EQUIVALENCE|80% power|Mean Difference (Net)|0.2|||<|0.05|||||||Sign test|||"The Nocturnal off-symptoms was compared between the Once-daily of Ropinirole PR arm and the Twice-daily of Ropinirole PR using the Wilcoxon signed rank test."||||<0.05
72551732|NCT00986245|144633764|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.4|||<|0.05||||||80% power|Sign test|||"The Early morning off symptoms was compared between the Once-daily of Ropinirole PR arm and the Twice-daily of Ropinirole PR using the Wilcoxon signed rank test."||||<0.05
72551733|NCT00986245|144633765|NON_INFERIORITY_OR_EQUIVALENCE|80% power|Mean Difference (Final Values)|0.1|||<|0.05|||||||Sign test|||"The Epworth sleep scale was compared between the Once-daily of Ropinirole PR arm and the Twice-daily of Ropinirole PR using the Wilcoxon signed rank test."||||<0.05
72551734|NCT00986245|144633766|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.8|||<|0.05|||||||Sign test|||||||<0.05
72551735|NCT02158494|144633773|SUPERIORITY|||||||0.41|||||||t-test, 2 sided|||P-Value for Sensory Organization Test results at 2 weeks||||0.41
72551736|NCT02158494|144633773|SUPERIORITY|||||||0.47|||||||t-test, 2 sided|||P-Value for Sensory Organization Test results at 14 weeks||||0.47
72551737|NCT02158494|144633773|SUPERIORITY|||||||0.99|||||||t-test, 2 sided|||P-Value for Sensory Organization Test results at 26 weeks||||0.99
72551738|NCT01214850|144633784|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.185||||0.3828|TWO_SIDED|95.0|0.809|1.737|||Regression, Logistic|||Vaccine Group Odds Ratios for carriage of virulent ST strain of N. meningitidis group B in 4CMenB group as compared to the control group at 1 month after receiving the 2nd rMenB+OMV NZ vaccination||1.737|0.809|0.3828
72551739|NCT01214850|144633785|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.84|||||TWO_SIDED|95.0|0.555|1.273|||Regression, Logistic|||Vaccine Group Odds Ratios for carriage of combined N. meningitidis serogroups A, C, W, Y in the MenACWY-CRM group compared to Control group at 1 month after receiving 1 injection of MenACWY vaccine||1.273|0.555|
72551740|NCT00854308|144633839|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.086||||0.6873|TWO_SIDED|95.0|0.727|1.622|||Log Rank||The hazard ratio was estimated using Cox Regression and was stratified for smoking status, Eastern Cooperative Oncology Group (ECOG) performance status and histology. The hazard ratio is relative to Placebo + Erlotinib.|The null hypothesis is that there is no difference in PFS between MetMab + Erlotinib and Placebo + Erlotinib. The alternate hypothesis is that MetMab + Erlotinib would have prolonged PFS compared with Placebo + Erlotinib.||1.622|0.727|0.6873
72552987|NCT02255097|144637037|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||exact binomial distribution|H0: p ≤ 0.05 versus H1: p \> 0.05||Analysis comparing the ORR for pembrolizumab to a fixed efficacy target of 5% using an exact test of binomial distribution||||<0.001
72413150|NCT02528214|144334947|SUPERIORITY|Testing was performed according to the hierarchical testing procedure (continued only if previous endpoints were statistically significant).|Odds Ratio (OR)|2.57||||0.0024|TWO_SIDED|95.0|1.4|4.73||Threshold for significance at 0.05.|Regression, Logistic||Dupilumab 300 mg q2w v Placebo q2w|The outcome was analyzed using a logistic regression model. The model included binary status of whether or not a participant achieved their maximum possible reduction of OCS dose per protocol at Week 24 as the response variable, treatment groups, optimized OCS dose at baseline, regions, and baseline eosinophil level subgroups as covariates. Missing data was imputed by using a pattern mixture model by multiple imputation approach.||4.73|1.4|0.0024
72584083|NCT03296527|144699082|NON_INFERIORITY|If the lower-limit of the two-sided 95% confidence interval (CI) was greater than the non-inferiority limit (-10.0%), the null hypothesis was rejected. In that case, it would be claimed that FE 999049 was non-inferior to GONAL-F with respect to ongoing pregnancy rate in women undergoing controlled ovarian stimulation.|Risk Difference (RD)|5.4|||||TWO_SIDED|95.0|-0.2|11.0|||||The difference (FE 999049 - GONAL-F) in rates was estimated and a two-sided 95% Cl was constructed using the Mantel-Haenszel method to combine results across age strata.|Percentage of participants with ongoing pregnancy rate||11.0|-0.2|
72584084|NCT03296527|144699083|OTHER||Risk Difference (RD)|6.3|||||TWO_SIDED|95.0|0.3|12.3|||||The difference (FE 999049 - GONAL-F) in rates was estimated and a two-sided 95% Cl was constructed using the Mantel-Haenszel method to combine results across age strata.|Percentage of participants with positive beta-hCG||12.3|0.3|
72584085|NCT03296527|144699084|OTHER||Risk Difference (RD)|4.9|||||TWO_SIDED|95.0|-0.9|10.7|||||The difference (FE 999049 - GONAL-F) in rates was estimated and a two-sided 95% Cl was constructed using the Mantel-Haenszel method to combine results across age strata.|Percentage of participants with at least one gestational sac 5-6 weeks after transfer||10.7|-0.9|
72584086|NCT03296527|144699085|OTHER||Risk Difference (RD)|4.2|||||TWO_SIDED|95.0|-1.5|9.8|||||The difference (FE 999049 - GONAL-F) in rates was estimated and a two-sided 95% Cl was constructed using the Mantel-Haenszel method to combine results across age strata.|Percentage of participants with at least one intrauterine gestational sac with fetal heart beat 5-6 weeks after transfer||9.8|-1.5|
72584087|NCT03296527|144699086|OTHER||Risk Difference (RD)|3.9|||||TWO_SIDED|95.0|-1.6|9.5|||||The difference (FE 999049 - GONAL-F) in rates was estimated and a two-sided 95% Cl was constructed using the Mantel-Haenszel method to combine results across age strata.|Percentage of implanted embryos 5-6 weeks after transfer||9.5|-1.6|
72584088|NCT03296527|144699087|OTHER||Risk Difference (RD)|4.4|||||TWO_SIDED|95.0|-0.9|9.7|||||The difference (FE 999049 - GONAL-F) in rates was estimated and a two-sided 95% Cl was constructed using the Mantel-Haenszel method to combine results across age strata.|Percentage of participants with ongoing implantation rate||9.7|-0.9|
72584089|NCT03296527|144699088|SUPERIORITY|Logistic regression including AMH group as a factor.|Odds Ratio (OR)|0.79||||0.083|TWO_SIDED|95.0|0.6|1.03||The p-value is based on the likelihood ratio test.|Regression, Logistic||Odds ratio is equal to FE 999049/GONAL-F.|Proportion of participants with \<4 or \>=15 oocytes retrieved||1.03|0.60|0.083
72584090|NCT03296527|144699088|OTHER|Logistic regression including AMH group as a factor.|Odds Ratio (OR)|0.89||||0.489|TWO_SIDED|95.0|0.65|1.23||The p-value is based on the likelihood ratio test.|Regression, Logistic||Odds ratio is equal to FE 999049/GONAL-F.|Proportion of participants with \<4 or \>=20 oocytes retrieved||1.23|0.65|0.489
72584091|NCT03296527|144699089|OTHER|Treatment groups were compared using a logistic regression model including age stratum as factor.|Odds Ratio (OR)|0.6||||0.075|TWO_SIDED|95.0|0.34|1.06||The p-value is based on the likelihood ratio test.|Regression, Logistic||Odds ratio is equal to FE 999049/GONAL-F.|Proportion of participants with early OHSS (any grade)||1.06|0.34|0.075
72584092|NCT03296527|144699089|OTHER|Treatment groups were compared using a logistic regression model including age stratum as factor.|Odds Ratio (OR)|0.75||||0.365|TWO_SIDED|95.0|0.4|1.4||The p-value is based on the likelihood ratio test.|Regression, Logistic||Odds ratio is equal to FE 999049/GONAL-F.|Proportion of participants with early OHSS (moderate/severe)||1.40|0.40|0.365
72413151|NCT02528214|144334948|SUPERIORITY|Testing was performed according to the hierarchical testing procedure (continued only if previous endpoints were statistically significant).|Odds Ratio (OR)|2.74||||0.0015|TWO_SIDED|95.0|1.47|5.1||Threshold for significance at 0.05.|Regression, Logistic||Dupilumab 300 mg q2w v Placebo q2w|The outcome measure was analyzed using a logistic regression model. The model included the binary status of whether or not a participant no longer required OCS at Week 24 as the response variable, and treatment groups, optimized OCS dose at baseline, regions, and baseline eosinophil level subgroups as covariates. Missing data was imputed using a pattern mixture model by multiple imputation approach.||5.1|1.47|0.0015
72584093|NCT03296527|144699089|OTHER|Treatment groups were compared using a logistic regression model including age stratum as factor.|Odds Ratio (OR)|0.33||||0.012|TWO_SIDED|95.0|0.13|0.83||The p-value is based on the likelihood ratio test.|Regression, Logistic||Odds ratio is equal to FE 999049/GONAL-F.|Proportion of participants with any preventive intervention||0.83|0.13|0.012
72584094|NCT03296527|144699089|OTHER|Treatment groups were compared using a logistic regression model including age stratum as factor.|Odds Ratio (OR)|0.49||||0.004|TWO_SIDED|95.0|0.3|0.81||The p-value is based on the likelihood ratio test.|Regression, Logistic||Odds ratio is equal to FE 999049/GONAL-F.|Proportion of participants with early OHSS (any grade) and/or preventive interventions||0.81|0.30|0.004
72584095|NCT03296527|144699089|OTHER|Treatment groups were compared using a logistic regression model including age stratum as factor.|Odds Ratio (OR)|0.56||||0.029|TWO_SIDED|95.0|0.33|0.95|||Regression, Logistic||Odds ratio is equal to FE 999049/GONAL-F.|Proportion of participants with early OHSS (moderate/severe) and/or preventive interventions||0.95|0.33|0.029
72552988|NCT02255097|144637040|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||exact binomial distribution|H0: p ≤ 0.05 versus H1: p \> 0.05||Analysis comparing the ORR for pembrolizumab to a fixed efficacy target of 5% using an exact test of binomial distribution||||<0.001
72551741|NCT00854308|144633840|SUPERIORITY_OR_OTHER|||||||0.7101||95.0||||P-value was stratified for smoking status, ECOG performance status and histology.|Cochran-Mantel-Haenszel|||The null hypothesis is that there is no difference in Objective Response between MetMab + Erlotinib and Placebo + Erlotinib. The alternate hypothesis is that MetMab + Erlotinib would have better Objective Response compared with Placebo + Erlotinib.||||0.7101
72551742|NCT00854308|144633841|SUPERIORITY_OR_OTHER|||||||0.3671||95.0||||P-value was stratified for smoking status, ECOG performance status and histology.|Cochran-Mantel-Haenszel|||The null hypothesis is that there is no difference in Objective Response between MetMab + Erlotinib and Placebo + Erlotinib. The alternate hypothesis is that MetMab + Erlotinib would have better Objective Response compared with Placebo + Erlotinib||||0.3671
72551743|NCT00854308|144633842|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.529||||0.0418|TWO_SIDED|95.0|0.284|0.986|||Log Rank||The hazard ratio was estimated using Cox Regression and was stratified for smoking status, ECOG performance status and histology. The hazard ratio is relative to Placebo + Erlotinib.|The null hypothesis is that there is no difference in PFS between MetMab + Erlotinib and Placebo + Erlotinib. The alternate hypothesis is that MetMab + Erlotinib would have prolonged PFS compared with Placebo + Erlotinib.||0.986|0.284|0.0418
72551744|NCT03252353|144633896|SUPERIORITY|||||||0.0079|||||||Regression, Logistic|The adjusted proportion of responders is 58.16 for Octreotide Capsule Treatment Group vs. 19.42 for the Placebo||The proportion of \[IGF-1/GH\] responders was compared between treatment groups using an exact logistic regression model with categorical covariates for treatment group, prior SRL dose, and baseline \[IGF-1/GH\] level||||0.0079
72551745|NCT03252353|144633897|SUPERIORITY|||||||0.0007|||||||Regression, Logistic|The adjusted proportion of responders is 77.66 for Octreotide Capsule Treatment Group vs. 30.40 for the Placebo||The proportion of \[IGF-1/GH\] responders was compared between treatment groups using an exact logistic regression model with categorical covariates for treatment group, prior SRL dose, and baseline \[IGF-1/GH\] level||||0.0007
72551746|NCT03252353|144633898|SUPERIORITY|||||||0.0029|||||||Fisher Exact|||||||0.0029
72551747|NCT02008565|144633899|SUPERIORITY|||||||0.092||||||significance assessed at type 1 error alpha=0.05|Mixed Models Analysis|The models were adjusted for baseline Irritable Bowel Syndrome (IBS) status and clinical site.||||||0.092
72551748|NCT03435081|144633929|SUPERIORITY||Odds Ratio (OR)|4.6|||<|0.001|TWO_SIDED|95.0|2.31|9.15|||Regression, Logistic|||||9.15|2.31|<0.001
72551749|NCT03435081|144633930|SUPERIORITY||Odds Ratio (OR)|2.51||||0.033|TWO_SIDED|95.0|1.08|5.83|||Regression, Logistic|||||5.83|1.08|0.033
72551750|NCT03435081|144633930|SUPERIORITY||Odds Ratio (OR)|5.29|||<|0.001|TWO_SIDED|95.0|2.4|11.68|||Regression, Logistic|||||11.68|2.40|<0.001
72551751|NCT03435081|144633931|SUPERIORITY||Odds Ratio (OR)|1.71||||0.167|TWO_SIDED|95.0|0.8|3.63|||Regression, Logistic|||||3.63|0.80|0.167
72551752|NCT03435081|144633932|SUPERIORITY||Odds Ratio (OR)|2.23||||0.131|TWO_SIDED|95.0|0.79|6.31|||Regression, Logistic|||||6.31|0.79|0.131
72551753|NCT03435081|144633932|SUPERIORITY||Odds Ratio (OR)|6.73|||<|0.001|TWO_SIDED|95.0|2.63|17.19|||Regression, Logistic|||||17.19|2.63|<0.001
72551754|NCT03435081|144633933|SUPERIORITY||Mean Difference (Final Values)|-12.59|STANDARD_ERROR_OF_MEAN|7.079||0.077|TWO_SIDED|95.0|-26.54|1.36|||Mixed Models Analysis|||||1.36|-26.54|0.077
72551755|NCT03435081|144633933|SUPERIORITY||Mean Difference (Final Values)|-20.3|STANDARD_ERROR_OF_MEAN|6.875||0.004|TWO_SIDED|95.0|-33.85|-6.75|||Mixed Models Analysis|||||-6.75|-33.85|0.004
72584096|NCT03296527|144699090|OTHER|Treatment groups were compared using a logistic regression model including age stratum as factor.|Odds Ratio (OR)|4.58||||0.002|TWO_SIDED|95.0|1.52|13.74||The p-value is based on the likelihood ratio test.|Regression, Logistic||Odds ratio is equal to FE 999049/GONAL-F.|Proportion of participants with cycle cancellation due to poor response||13.74|1.52|0.002
72584097|NCT03296527|144699090|OTHER|Treatment groups were compared using a logistic regression model including age stratum as factor.|Odds Ratio (OR)|0.39|||<|0.001|TWO_SIDED|95.0|0.24|0.62||The p-value is based on the likelihood ratio test.|Regression, Logistic||Odds ratio is equal to FE 999049/GONAL-F.|Proportion of participants with transfer cancellation due to excessive ovarian response/OHSS risk||0.62|0.24|<0.001
72584098|NCT03296527|144699090|OTHER|Treatment groups were compared using a logistic regression model including age stratum as factor.|Odds Ratio (OR)|0.62||||0.02|TWO_SIDED|95.0|0.42|0.93||The p-value is based on the likelihood ratio test.|Regression, Logistic||Odds ratio is equal to FE 999049/GONAL-F.|Proportion of participants with cycle cancellation due to poor or excessive response, or transfer cancellation due to excessive response/OHSS risk||0.93|0.42|0.020
72584099|NCT03296527|144699091|SUPERIORITY||||||<|0.001||||||2-sided|van Elteren test|p-value based on van Elteren test adjusted for age stratum.||Number of follicles \>= 10 mm||||<.001
72584100|NCT03296527|144699091|SUPERIORITY||||||<|0.001||||||2-sided|van Elteren test|p-value based on van Elteren test adjusted for age stratum.||Number of follicles \>= 12 mm||||<.001
72413152|NCT00941603|144334971|SUPERIORITY_OR_OTHER||Difference in percent|-3.5||||0.06|TWO_SIDED|95.0|-7.2|0.2|||ANOVA|Least-square (LS) means and LS standard errors based on ANOVA model extracting effects due to treatment, gender, and primary diagnosis.||||0.2|-7.2|0.06
72584101|NCT03296527|144699091|SUPERIORITY|||||||0.568||||||2-sided|van Elteren test|p-value based on van Elteren test adjusted for age stratum.||Number of follicles \>= 15 mm||||0.568
72584102|NCT03296527|144699091|SUPERIORITY|||||||0.839||||||2-sided|van Elteren test|p-value based on van Elteren test adjusted for age stratum.||Number of follicles \>= 17 mm||||0.839
72584103|NCT03296527|144699092|SUPERIORITY||||||<|0.001|||||||van Elteren test|p-value based on van Elteren test adjusted for age stratum.||Number of follicles \>= 10 mm||||<.001
72584104|NCT03296527|144699092|SUPERIORITY||||||<|0.001|||||||van Elteren test|p-value based on van Elteren test adjusted for age stratum.||Number of follicles \>= 12 mm||||<.001
72584105|NCT03296527|144699092|SUPERIORITY||||||<|0.001|||||||van Elteren test|p-value based on van Elteren test adjusted for age stratum.||Number of follicles \>= 15 mm||||<.001
72584106|NCT03296527|144699092|SUPERIORITY|||||||0.011|||||||van Elteren test|p-value based on van Elteren test adjusted for age stratum.||Number of follicles \>= 17 mm||||0.011
72584107|NCT03296527|144699093|SUPERIORITY|||||||0.14|||||||van Elteren test|p-value based on van Elteren test adjusted for age stratum.||Largest follicle (mm)||||0.140
72413153|NCT00941603|144334971|SUPERIORITY_OR_OTHER||Difference in percent|-3.1||||0.1|TWO_SIDED|95.0|-6.7|0.6||LS means and LS standard errors based on ANOVA model extracting effects due to treatment, gender, and primary diagnosis.|ANOVA|||||0.6|-6.7|0.10
72584108|NCT03296527|144699093|SUPERIORITY|||||||0.155|||||||van Elteren test|p-value based on van Elteren test adjusted for age stratum.||Average follicle size (mm)||||0.155
72584109|NCT03296527|144699093|SUPERIORITY|||||||0.159|||||||van Elteren test|p-value based on van Elteren test adjusted for age stratum.||Treatment comparison: Average size of 3 largest follicles (mm)||||0.159
72584110|NCT03296527|144699094|SUPERIORITY|||||||0.848|||||||van Elteren test|p-value based on van Elteren test adjusted for age stratum.||Largest follicle (mm)||||0.848
72584111|NCT03296527|144699094|SUPERIORITY|||||||0.629|||||||van Elteren test|p-value based on van Elteren test adjusted for age stratum.||Average follicle size (mm)||||0.629
72413154|NCT00941603|144334971|SUPERIORITY_OR_OTHER||Difference in percent|-5.7|||<|0.01|TWO_SIDED|95.0|-9.4|-2.0|||ANOVA|||LS means and LS standard errors based on ANOVA model extracting effects due to treatment, gender, and primary diagnosis.||-2.0|-9.4|<0.01
72584112|NCT03296527|144699094|SUPERIORITY|||||||0.768|||||||van Elteren test|p-value based on van Elteren test adjusted for age stratum.||Average size of 3 largest follicles (mm)||||0.768
72584113|NCT03296527|144699095|SUPERIORITY||||||<|0.001|||||||van Elteren test|p-value based on van Elteren test adjusted for age stratum.||Mean number of oocytes retrieved||||<.001
72584114|NCT03296527|144699097|SUPERIORITY|||||||0.197|||||||van Elteren test|p-value based on van Elteren test adjusted for age stratum.||Percentage of MII oocytes / oocytes retrieved||||0.197
72584115|NCT03296527|144699098|SUPERIORITY|||||||0.79|||||||van Elteren test|p-value based on van Elteren test adjusted for age stratum.||Fertilization rate relative to oocytes retrieved||||0.790
72584116|NCT03296527|144699099|SUPERIORITY||||||<|0.001|||||||van Elteren test|p-value based on van Elteren test adjusted for age stratum.||Number of embryos on day 3||||<.001
72584117|NCT03296527|144699099|SUPERIORITY||||||<|0.001|||||||van Elteren test|p-value based on van Elteren test adjusted for age stratum.||Number of good-quality embryos on Day 3||||<.001
72584118|NCT03296527|144699100|SUPERIORITY||Mean ratio|0.81|||<|0.001|TWO_SIDED|95.0|0.74|0.88||The p-value corresponds to F-test of treatment effect.|ANCOVA|The multiplicative ANCOVA model included treatment and age stratum as fixed factors.|Mean ratio is equal to FE 999049/GONAL-F.|Circulating concentrations of LH on stimulation Day 6||0.88|0.74|<0.001
72584119|NCT03296527|144699101|SUPERIORITY||Mean ratio|0.9||||0.018|TWO_SIDED|95.0|0.82|0.98||The p-value corresponds to F-test of treatment effect.|ANCOVA|The multiplicative ANCOVA model included treatment and age stratum as fixed factors.||Circulating concentrations of LH at end-of-stimulation||0.98|0.82|0.018
72551756|NCT03435081|144633934|SUPERIORITY||Odds Ratio (OR)|1.24||||0.733|TWO_SIDED|95.0|0.36|4.36|||Regression, Logistic|||||4.36|0.36|0.733
72551757|NCT03435081|144633934|SUPERIORITY||Odds Ratio (OR)|5.42||||0.002|TWO_SIDED|95.0|1.93|15.22|||Regression, Logistic|||||15.22|1.93|0.002
72551758|NCT03435081|144633935|SUPERIORITY||Odds Ratio (OR)|3.08||||0.012|TWO_SIDED|95.0|1.29|7.36|||Regression, Logistic|||||7.36|1.29|0.012
72551759|NCT03435081|144633935|SUPERIORITY||Odds Ratio (OR)|5.32|||<|0.001|TWO_SIDED|95.0|2.31|12.28|||Regression, Logistic|||||12.28|2.31|<0.001
72551760|NCT03435081|144633936|SUPERIORITY||Mean Difference (Final Values)|-0.21|STANDARD_ERROR_OF_MEAN|0.273||0.433|TWO_SIDED|95.0|-0.75|0.32|||Mixed Models Analysis|||||0.32|-0.75|0.433
72551761|NCT03435081|144633936|SUPERIORITY||Mean Difference (Final Values)|-0.59|STANDARD_ERROR_OF_MEAN|0.269||0.029|TWO_SIDED|95.0|-1.12|-0.06|||Mixed Models Analysis|||||-0.06|-1.12|0.029
72551762|NCT03435081|144633937|SUPERIORITY||Mean Difference (Final Values)|-1.12|STANDARD_ERROR_OF_MEAN|0.441||0.012|TWO_SIDED|95.0|-1.99|-0.25|||Mixed Models Analysis|||||-0.25|-1.99|0.012
72551763|NCT03435081|144633937|SUPERIORITY||Mean Difference (Final Values)|-1.36|STANDARD_ERROR_OF_MEAN|0.433||0.002|TWO_SIDED|95.0|-2.22|-0.51|||Mixed Models Analysis|||||-0.51|-2.22|0.002
72551764|NCT03435081|144633938|SUPERIORITY||Odds Ratio (OR)|1.69||||0.105|TWO_SIDED|95.0|0.9|3.2|||Regression, Logistic|||||3.20|0.90|0.105
72551765|NCT03435081|144633938|SUPERIORITY||Odds Ratio (OR)|3.67|||<|0.001|TWO_SIDED|95.0|2.02|6.68|||Regression, Logistic|||||6.68|2.02|<0.001
72551766|NCT03435081|144633939|SUPERIORITY||Odds Ratio (OR)|3.81||||0.144|TWO_SIDED|95.0|0.63|22.85|||Regression, Logistic|||||22.85|0.63|0.144
72551767|NCT03435081|144633939|SUPERIORITY||Odds Ratio (OR)|3.1||||0.227|TWO_SIDED|95.0|0.5|19.4|||Regression, Logistic|||||19.40|0.50|0.227
72551768|NCT03435081|144633940|SUPERIORITY||Mean Difference (Final Values)|-3.94|STANDARD_ERROR_OF_MEAN|3.921||0.316|TWO_SIDED|95.0|-11.67|3.79|||Mixed Models Analysis|||||3.79|-11.67|0.316
72551769|NCT03435081|144633940|SUPERIORITY||Mean Difference (Final Values)|-11.81|STANDARD_ERROR_OF_MEAN|3.758||0.002|TWO_SIDED|95.0|-19.23|-4.4|||Mixed Models Analysis|||||-4.40|-19.23|0.002
72551770|NCT03435081|144633941|SUPERIORITY||Odds Ratio (OR)|1.39||||0.683|TWO_SIDED|95.0|0.29|6.78|||Regression, Logistic|||||6.78|0.29|0.683
72551771|NCT03435081|144633941|SUPERIORITY||Odds Ratio (OR)|2.25||||0.277|TWO_SIDED|95.0|0.52|9.68|||Regression, Logistic|||||9.68|0.52|0.277
72551772|NCT03435081|144633942|SUPERIORITY||Mean Difference (Final Values)|-6.02|STANDARD_ERROR_OF_MEAN|2.996||0.046|TWO_SIDED|95.0|-11.93|-0.12|||Mixed Models Analysis|||||-0.12|-11.93|0.046
72413155|NCT00941603|144334971|SUPERIORITY_OR_OTHER||Difference in percent|-1.3||||0.48|TWO_SIDED|95.0|-5.0|2.4|||ANOVA|LS means and LS standard errors based on ANOVA model extracting effects due to treatment, gender, and primary diagnosis.||||2.4|-5.0|0.48
72551773|NCT03435081|144633942|SUPERIORITY||Mean Difference (Final Values)|-7.72|STANDARD_ERROR_OF_MEAN|2.911||0.009|TWO_SIDED|95.0|-13.46|-1.98|||Mixed Models Analysis|||||-1.98|-13.46|0.009
72551774|NCT03435081|144633943|SUPERIORITY|||||||0.598|||||||Fisher Exact|||||||0.598
72551775|NCT03435081|144633943|SUPERIORITY|||||||0.785|||||||Fisher Exact|||||||0.785
72551776|NCT03435081|144633944|SUPERIORITY||Mean Difference (Final Values)|-12.27|STANDARD_ERROR_OF_MEAN|6.562||0.063|TWO_SIDED|95.0|-25.21|0.66|||Mixed Models Analysis|||||0.66|-25.21|0.063
72551777|NCT03435081|144633944|SUPERIORITY||Mean Difference (Final Values)|-21.85|STANDARD_ERROR_OF_MEAN|6.437|<|0.001|TWO_SIDED|95.0|-34.54|-9.17|||Mixed Models Analysis|||||-9.17|-34.54|<0.001
72551778|NCT03435081|144633945|SUPERIORITY||Mean Difference (Final Values)|-1.9|STANDARD_ERROR_OF_MEAN|1.536||0.217|TWO_SIDED|95.0|-4.93|1.12|||Mixed Models Analysis|||||1.12|-4.93|0.217
72551779|NCT03435081|144633945|SUPERIORITY||Mean Difference (Final Values)|-4.77|STANDARD_ERROR_OF_MEAN|1.487||0.002|TWO_SIDED|95.0|-7.7|-1.84|||Mixed Models Analysis|||||-1.84|-7.70|0.002
72584120|NCT03296527|144699102|SUPERIORITY||Mean ratio|0.77|||<|0.001|TWO_SIDED|95.0|0.7|0.84||The p-value corresponds to F-test of treatment effect.|ANCOVA|The multiplicative ANCOVA model included treatment and age stratum as fixed factors.|Mean ratio is equal to FE 999049/GONAL-F.|Circulating concentrations of Estradiol on stimulation Day 6||0.84|0.70|<0.001
72584121|NCT03296527|144699103|SUPERIORITY||Mean ratio|0.74|||<|0.001|TWO_SIDED|95.0|0.68|0.81||The p-value corresponds to F-test of treatment effect.|ANCOVA|The multiplicative ANCOVA model included treatment and age stratum as fixed factors.|Mean ratio is equal to FE 999049/GONAL-F.|Circulating concentrations of Estradiol at end-of-stimulation||0.81|0.68|<0.001
72584122|NCT03296527|144699104|SUPERIORITY||Mean Ratio|0.89||||0.003|TWO_SIDED|95.0|0.82|0.96||The p-value corresponds to the two-sided F-test of treatment effect.|ANCOVA|The multiplicative ANCOVA model included treatment and age stratum as fixed factors.|Mean ratio is equal to FE 999049/GONAL-F.|Circulating concentrations of Progesterone on stimulation Day 6||0.96|0.82|0.003
72584123|NCT03296527|144699105|SUPERIORITY||Mean ratio|0.74|||<|0.001|TWO_SIDED|95.0|0.68|0.79||The p-value corresponds to F-test of treatment effect.|ANCOVA|The multiplicative ANCOVA model included treatment and age stratum as fixed factors.|Mean ratio is equal to FE 999049/GONAL-F.|Circulating concentrations of Progesterone at end-of-stimulation||0.79|0.68|<0.001
72413156|NCT00941603|144334971|SUPERIORITY_OR_OTHER||Difference in percent|-0.4||||0.85|TWO_SIDED|95.0|-4.0|3.3|||ANOVA|LS means and LS standard errors based on ANOVA model extracting effects due to treatment, gender, and primary diagnosis.||||3.3|-4.0|0.85
72413157|NCT00941603|144334972|SUPERIORITY_OR_OTHER||Difference in percent|-3.0||||0.09|TWO_SIDED|95.0|-6.5|0.4|||ANOVA|LS means and LS standard errors based on ANOVA model extracting effects due to treatment, gender, and primary diagnosis.||||0.4|-6.5|0.09
72551780|NCT03435081|144633946|SUPERIORITY||Mean Difference (Final Values)|-0.25|STANDARD_ERROR_OF_MEAN|0.178||0.155|TWO_SIDED|95.0|-0.6|0.1|||Mixed Models Analysis|||||0.10|-0.60|0.155
72413158|NCT00941603|144334972|SUPERIORITY_OR_OTHER||Difference in percent|-3.6||||0.04|TWO_SIDED|95.0|-7.1|-0.2|||ANOVA|LS means and LS standard errors based on ANOVA model extracting effects due to treatment, gender, and primary diagnosis.||||-0.2|-7.1|0.04
72551781|NCT03435081|144633946|SUPERIORITY||Mean Difference (Final Values)|-0.42|STANDARD_ERROR_OF_MEAN|0.174||0.017|TWO_SIDED|95.0|-0.76|-0.07|||Mixed Models Analysis|||||-0.07|-0.76|0.017
72551782|NCT03435081|144633947|SUPERIORITY||Mean Difference (Final Values)|0.53|STANDARD_ERROR_OF_MEAN|0.565||0.345|TWO_SIDED|95.0|-0.58|1.65|||Mixed Models Analysis|||Anxiety||1.65|-0.58|0.345
72551783|NCT03435081|144633947|SUPERIORITY||Mean Difference (Final Values)|-0.52|STANDARD_ERROR_OF_MEAN|0.543||0.336|TWO_SIDED|95.0|-1.59|0.55|||Mixed Models Analysis|||Anxiety||0.55|-1.59|0.336
72551784|NCT03435081|144633947|SUPERIORITY||Mean Difference (Final Values)|0.43|STANDARD_ERROR_OF_MEAN|0.465||0.353|TWO_SIDED|95.0|-0.48|1.35|||Mixed Models Analysis|||Depression||1.35|-0.48|0.353
72551785|NCT03435081|144633947|SUPERIORITY||Mean Difference (Final Values)|-0.43|STANDARD_ERROR_OF_MEAN|0.446||0.34|TWO_SIDED|95.0|-1.31|0.45|||Mixed Models Analysis|||Depression||0.45|-1.31|0.340
72551786|NCT03435081|144633948|SUPERIORITY||Mean Difference (Final Values)|-1.5|STANDARD_ERROR_OF_MEAN|1.228||0.224|TWO_SIDED|95.0|-3.92|0.92|||Mixed Models Analysis|||||0.92|-3.92|0.224
72551787|NCT03435081|144633948|SUPERIORITY||Mean Difference (Final Values)|-3.5|STANDARD_ERROR_OF_MEAN|1.184||0.004|TWO_SIDED|95.0|-5.83|-1.16|||Mixed Models Analysis|||||-1.16|-5.83|0.004
72551788|NCT03435081|144633949|SUPERIORITY||Mean Difference (Final Values)|-3.36|STANDARD_ERROR_OF_MEAN|5.956||0.575|TWO_SIDED|95.0|-15.3|8.57|||Mixed Models Analysis|||Absenteeism Change from Baseline||8.57|-15.30|0.575
72551789|NCT03435081|144633949|SUPERIORITY||Mean Difference (Final Values)|-1.07|STANDARD_ERROR_OF_MEAN|5.664||0.851|TWO_SIDED|95.0|-12.43|10.3|||Mixed Models Analysis|||Absenteeism Change from Baseline||10.30|-12.43|0.851
72551790|NCT03435081|144633949|SUPERIORITY||Mean Difference (Final Values)|-11.75|STANDARD_ERROR_OF_MEAN|5.212||0.026|TWO_SIDED|95.0|-22.05|-1.45|||Mixed Models Analysis|||Presenteeism Change from Baseline||-1.45|-22.05|0.026
72551791|NCT03435081|144633949|SUPERIORITY||Mean Difference (Final Values)|-15.9|STANDARD_ERROR_OF_MEAN|5.056||0.002|TWO_SIDED|95.0|-25.89|-5.91|||Mixed Models Analysis|||Presenteeism Change from Baseline||-5.91|-25.89|0.002
72551792|NCT03435081|144633949|SUPERIORITY||Mean Difference (Final Values)|-12.85|STANDARD_ERROR_OF_MEAN|6.237||0.041|TWO_SIDED|95.0|-25.18|-0.51|||Mixed Models Analysis|||Overall Work Impairment Change from Baseline||-0.51|-25.18|0.041
72551793|NCT03435081|144633949|SUPERIORITY||Mean Difference (Final Values)|-16.27|STANDARD_ERROR_OF_MEAN|6.034||0.008|TWO_SIDED|95.0|-28.2|-4.34|||Mixed Models Analysis|||Overall Work Impairment Change from Baseline||-4.34|-28.20|0.008
72584124|NCT03296527|144699106|SUPERIORITY||Mean ratio|0.76|||<|0.001|TWO_SIDED|95.0|0.7|0.83||The p-value corresponds to F-test of treatment effect.|ANCOVA|The multiplicative ANCOVA model included treatment and age stratum as fixed factors.||Circulating concentrations of Inhibin A on stimulation Day 6||0.83|0.70|<0.001
72584125|NCT03296527|144699107|SUPERIORITY||Mean ratio|0.77|||<|0.001|TWO_SIDED|95.0|0.71|0.83||The p-value corresponds to F-test of treatment effect.|ANCOVA|The multiplicative ANCOVA model included treatment and age stratum as fixed factors.|Mean ratio is equal to FE 999049/GONAL-F.|Circulating concentrations of Inhibin A at end-of-stimulation||0.83|0.71|<0.001
72551794|NCT03435081|144633949|SUPERIORITY||Mean Difference (Final Values)|-9.64|STANDARD_ERROR_OF_MEAN|4.219||0.023|TWO_SIDED|95.0|-17.95|-1.32|||Mixed Models Analysis|||Activity Impairment Change from Baseline||-1.32|-17.95|0.023
72551795|NCT03435081|144633949|SUPERIORITY||Mean Difference (Final Values)|-13.29|STANDARD_ERROR_OF_MEAN|4.115||0.001|TWO_SIDED|95.0|-21.4|-5.17|||Mixed Models Analysis|||Activity Impairment Change from Baseline||-5.17|-21.40|0.001
72551796|NCT03435081|144633950|SUPERIORITY||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.026||0.482|TWO_SIDED|95.0|-0.03|0.07|||Mixed Models Analysis|||Health State Index Score (US algorithm)||0.07|-0.03|0.482
72551797|NCT03435081|144633950|SUPERIORITY||Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.026||0.043|TWO_SIDED|95.0|0.0|0.1|||Mixed Models Analysis|||Health State Index Score (US algorithm)||0.10|0.00|0.043
72551798|NCT03435081|144633950|SUPERIORITY||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.037||0.656|TWO_SIDED|95.0|-0.06|0.09|||Mixed Models Analysis|||Health State Index Score (UK algorithm)||0.09|-0.06|0.656
72551799|NCT03435081|144633950|SUPERIORITY||Mean Difference (Final Values)|0.07|STANDARD_ERROR_OF_MEAN|0.036||0.057|TWO_SIDED|95.0|0.0|0.14|||Mixed Models Analysis|||Health State Index Score (UK algorithm)||0.14|-0.00|0.057
72551800|NCT03435081|144633951|SUPERIORITY||Mean Difference (Final Values)|-1.33|STANDARD_ERROR_OF_MEAN|2.597||0.609|TWO_SIDED|95.0|-6.45|3.79|||Mixed Models Analysis|||||3.79|-6.45|0.609
72551801|NCT03435081|144633951|SUPERIORITY||Mean Difference (Final Values)|3.48|STANDARD_ERROR_OF_MEAN|2.503||0.166|TWO_SIDED|95.0|-1.46|8.41|||Mixed Models Analysis|||||8.41|-1.46|0.166
72551802|NCT03435081|144633952|SUPERIORITY||Odds Ratio (OR)|1.96||||0.258|TWO_SIDED|95.0|0.61|6.26|||Regression, Logistic|||||6.26|0.61|0.258
72551803|NCT03435081|144633952|SUPERIORITY||Odds Ratio (OR)|2.99||||0.052|TWO_SIDED|95.0|0.99|8.97|||Regression, Logistic|||||8.97|0.99|0.052
72551804|NCT04320849|144633956|OTHER||Slope|0.0675|||||ONE_SIDED|90.0||0.106||||||"The following set of hypotheses were used to evaluate the relationship between lead stiffness and curvature in the extravenous region:~H0: a ≥ 0 Ha: a \< 0 where a represents the coefficient for stiffness in the following model: log (curvature) = a\*stiffness + b + normally distributed error."||0.106||
72552989|NCT02255097|144637041|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0027|||||||exact binomial distribution|H0: p ≤ 0.05 versus H1: p \> 0.05||Analysis comparing the ORR for pembrolizumab to a fixed efficacy target of 5% using an exact test of binomial distribution||||0.0027
72551805|NCT04320849|144633957|OTHER||Slope|0.199|||||ONE_SIDED|90.0||0.397||||||"The following set of hypotheses will be used to evaluate the relationship between lead stiffness and curvature in the intracardiac region:~H0: a ≥ 0 Ha: a \< 0 where a represents the coefficient for stiffness in the following model: log (curvature) = a\*stiffness + b + normally distributed error."||0.397||
72551806|NCT04320849|144633958|OTHER||Slope|-0.015|||||ONE_SIDED|90.0||0.0123||||||"The following set of hypotheses were used to evaluate the relationship between lead stiffness and curvature in the connector region:~H0: a ≥ 0 Ha: a \< 0 where a represents the coefficient for stiffness in the following model: log (curvature) = a\*stiffness + b + normally distributed error."||0.0123||
72551807|NCT04753437|144634065|EQUIVALENCE|Results were based on analysis of variance model with treatment as a fixed effect.|Geometric Least Squares (LS) Mean Ratio|1.3|||||TWO_SIDED|90.0|0.94|1.81||||||||1.81|0.94|
72551808|NCT04753437|144634066|EQUIVALENCE|Results were based on analysis of variance model with treatment as a fixed effect.|Geometric LS Mean Ratio|1.07|||||TWO_SIDED|90.0|0.82|1.4||||||||1.40|0.82|
72551809|NCT00581139|144634110|SUPERIORITY|||||||0.02|||||||ANOVA|||||||.02
72551810|NCT00581139|144634112|SUPERIORITY|||||||0.01|||||||Chi-squared|||||||.01
72551811|NCT00581139|144634113|SUPERIORITY|||||||0.01|||||||Chi-squared|||||||.01
72551812|NCT00581139|144634114|SUPERIORITY|||||||0.01|||||||Chi-squared|||||||.01
72551813|NCT00581139|144634115|SUPERIORITY|||||||0.02|||||||ANOVA|||||||.02
72551814|NCT00581139|144634116|SUPERIORITY|||||||0.04|||||||ANOVA|||||||.04
72551815|NCT00581139|144634117|SUPERIORITY|||||||0.04|||||||ANOVA|||||||.04
72551816|NCT01136382|144634129|SUPERIORITY_OR_OTHER||LS mean difference|13.6|STANDARD_ERROR_OF_MEAN|3.1|<|0.0001|TWO_SIDED|95.0|7.5|19.7||To address multiplicity, a step-down procedure was used. If the treatment difference for the primary variable, morning PEF, was statistically significant (p\<0.05), then the key secondary variable, FEV1, was tested at the 0.05 level of significance.|ANCOVA|||Change from baseline to treatment period average was analyzed using an analysis of covariance (ANCOVA) model with terms for treatment, age group (\<8 years and ≥8 years of age) and country with baseline as a covariate.||19.7|7.5|<0.0001
72551817|NCT01136382|144634130|SUPERIORITY_OR_OTHER||LS mean difference|0.06|STANDARD_ERROR_OF_MEAN|0.022||0.0047|TWO_SIDED|95.0|0.02|0.11||To address multiplicity, a step-down procedure was used. If the treatment difference for the primary variable, morning PEF, was statistically significant (p\<0.05), then the key secondary variable, FEV1, was tested at the 0.05 level of significance.|ANCOVA|||Change from baseline to treatment period average was analyzed using an analysis of covariance (ANCOVA) model with terms for treatment, age group (\<8 years and ≥8 years of age) and country with baseline as a covariate.||0.11|0.02|0.0047
72551818|NCT01136382|144634131|SUPERIORITY_OR_OTHER||LS mean difference|10.8|STANDARD_ERROR_OF_MEAN|3.0||0.0004|TWO_SIDED|95.0|4.9|16.7|||ANCOVA|||Change from baseline to treatment period average was analyzed using an ANCOVA model with terms for treatment, age group (\<8 years and ≥8 years of age) and country with baseline as a covariate.||16.7|4.9|0.0004
72551819|NCT01136382|144634132|SUPERIORITY_OR_OTHER||LS mean difference|0.04|STANDARD_ERROR_OF_MEAN|0.02||0.0673|TWO_SIDED|95.0|0.0|0.08|||ANCOVA|||Change from baseline to treatment period average was analyzed using an ANCOVA model with terms for treatment, age group (\<8 years and ≥8 years of age) and country with baseline as a covariate.||0.08|0.00|0.0673
72551820|NCT01136382|144634133|SUPERIORITY_OR_OTHER||LS mean difference|0.1|STANDARD_ERROR_OF_MEAN|0.044||0.0216|TWO_SIDED|95.0|0.01|0.19|||ANCOVA|||Change from baseline to treatment period average was analyzed using an ANCOVA model with terms for treatment, age group (\<8 years and ≥8 years of age) and country with baseline as a covariate.||0.19|0.01|0.0216
72551821|NCT01136382|144634134|SUPERIORITY_OR_OTHER||LS mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.06||0.0004|TWO_SIDED|95.0|-0.31|-0.09||Analysis for change in daytime asthma symptom score from baseline to treatment period average.|ANCOVA|||Change from baseline to treatment period average was analyzed using an ANCOVA model with terms for treatment, age group (\<8 years and ≥8 years of age) and country with baseline as a covariate.||-0.09|-0.31|0.0004
72551822|NCT01136382|144634134|SUPERIORITY_OR_OTHER||LS mean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.11||0.0015|TWO_SIDED|95.0|-0.55|-0.13||Analysis for change in total asthma symptom score from baseline to treatment period average.|ANCOVA|||Change from baseline to treatment period average was analyzed using an ANCOVA model with terms for treatment, age group (\<8 years and ≥8 years of age) and country with baseline as a covariate.||-0.13|-0.55|0.0015
72551823|NCT01136382|144634135|SUPERIORITY_OR_OTHER||LS mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.06||0.0079|TWO_SIDED|95.0|-0.26|-0.04|||ANCOVA|||Change from baseline to treatment period average was analyzed using an ANCOVA model with terms for treatment, age group (\<8 years and ≥8 years of age) and country with baseline as a covariate.||-0.04|-0.26|0.0079
72551824|NCT01136382|144634136|SUPERIORITY_OR_OTHER||LS mean difference|-4.7|STANDARD_ERROR_OF_MEAN|1.78||0.0095|TWO_SIDED|95.0|-8.2|-1.1||Analysis for change in nighttime awakenings from baseline to treatment period average.|ANCOVA|||Change from baseline to treatment period average was analyzed using an ANCOVA model with terms for treatment, age group (\<8 years and ≥8 years of age) and country with baseline as a covariate.||-1.1|-8.2|0.0095
72551825|NCT01136382|144634136|SUPERIORITY_OR_OTHER||LS mean difference|-3.9|STANDARD_ERROR_OF_MEAN|1.15||0.0007|TWO_SIDED|95.0|-6.2|-1.7||Analysis for change in nighttime awakenings with reliever medication use from baseline to treatment period average.|ANCOVA|||Change from baseline to treatment period average was analyzed using an ANCOVA model with terms for treatment, age group (\<8 years and ≥8 years of age) and country with baseline as a covariate.||-1.7|-6.2|0.0007
72413159|NCT00941603|144334972|SUPERIORITY_OR_OTHER||Difference in percent|-4.4||||0.01|TWO_SIDED|95.0|-7.9|-1.0|||ANOVA|LS means and LS standard errors based on ANOVA model extracting effects due to treatment, gender, and primary diagnosis.||||-1.0|-7.9|0.01
72551826|NCT01136382|144634137|SUPERIORITY_OR_OTHER||LS mean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.07||0.0001|TWO_SIDED|95.0|-0.4|-0.1||Analysis for change in daytime reliever medication use from baseline to treatment period average.|ANCOVA|||Change from baseline to treatment period average was analyzed using an ANCOVA model with terms for treatment, age group (\<8 years and ≥8 years of age) and country with baseline as a covariate.||-0.1|-0.4|0.0001
72551827|NCT01136382|144634137|SUPERIORITY_OR_OTHER||LS mean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001|TWO_SIDED|95.0|-0.7|-0.2||Analysis for change in total reliever medication use from baseline to treatment period average.|ANCOVA|||Change from baseline to treatment period average was analyzed using an ANCOVA model with terms for treatment, age group (\<8 years and ≥8 years of age) and country with baseline as a covariate.||-0.2|-0.7|<0.0001
72551828|NCT01136382|144634138|SUPERIORITY_OR_OTHER||LS mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.06|<|0.0001|TWO_SIDED|95.0|-0.3|-0.1|||ANCOVA|||Change from baseline to treatment period average was analyzed using an ANCOVA model with terms for treatment, age group (\<8 years and ≥8 years of age) and country with baseline as a covariate.||-0.1|-0.3|<0.0001
72413160|NCT00941603|144334972|SUPERIORITY_OR_OTHER||Difference in percent|-1.4||||0.41|TWO_SIDED|95.0|-4.9|2.0|||ANOVA|LS means and LS standard errors based on ANOVA model extracting effects due to treatment, gender, and primary diagnosis.||||2.0|-4.9|0.41
72413161|NCT00941603|144334972|SUPERIORITY_OR_OTHER||Difference in percent|0.7||||0.68|TWO_SIDED|95.0|-2.7|4.2|||ANOVA|LS means and LS standard errors based on ANOVA model extracting effects due to treatment, gender, and primary diagnosis.||||4.2|-2.7|0.68
72413162|NCT01040130|144335019|SUPERIORITY_OR_OTHER||Ratio to placebo|1.14|STANDARD_ERROR_OF_MEAN|0.04||0.0002||95.0|1.065|1.221|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline endurance time and period as fixed and patient as random effect. Means, CI back-transformed.|Olo 5 mcg divided by Placebo|||1.221|1.065|0.0002
72551829|NCT01136382|144634139|SUPERIORITY_OR_OTHER|||||||0.0004|||||||Log Rank|||||||0.0004
72413163|NCT01040130|144335019|SUPERIORITY_OR_OTHER||Ratio to placebo|1.138|STANDARD_ERROR_OF_MEAN|0.04||0.0003||95.0|1.062|1.219|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline endurance time and period as fixed and patient as random effect. Means, CI back-transformed.|Olo 10 mcg divided by Placebo|||1.219|1.062|0.0003
72413164|NCT01040130|144335020|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.182|STANDARD_ERROR_OF_MEAN|0.036|<|0.0001||95.0|0.112|0.252|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 5 mcg minus Placebo|||0.252|0.112|<0.0001
72413165|NCT01040130|144335020|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.174|STANDARD_ERROR_OF_MEAN|0.036|<|0.0001||95.0|0.104|0.245|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 10 mcg minus Placebo|||0.245|0.104|<0.0001
72413166|NCT01040130|144335021|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.766|STANDARD_ERROR_OF_MEAN|0.223||0.0007||95.0|-1.205|-0.326|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 5 mcg minus Placebo|||-0.326|-1.205|0.0007
72413167|NCT01040130|144335021|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.634|STANDARD_ERROR_OF_MEAN|0.225||0.0051||95.0|-1.077|-0.192|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 10 mcg minus Placebo|||-0.192|-1.077|0.0051
72551830|NCT00963482|144634140|SUPERIORITY_OR_OTHER||||||=|0.111||95.0||||not adjusted for multiple comparisons due to only two groups p\<.05, two-tailed|Chi-squared|||"H0: EG is equal in smoking quit rates compared to CG. H1: EG is superior in smoking quit rates compared to CG"||||=.111
72551831|NCT01045096|144634152|SUPERIORITY_OR_OTHER|||||||0.809||90.0|||||ANCOVA|||Sample size of 12 participants per dose group, along with the intense PK sampling in each regimen was needed for characterization of the PK profile. An analysis of variance with covariates (ANCOVA) model with weight as a covariate and regimen as a factor were fitted to Tmax. Pairwise comparisons between regimens were conducted.||||0.809
72552990|NCT02255097|144637042|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||exact binomial distribution|H0: p ≤ 0.05 versus H1: p \> 0.05||Analysis comparing the ORR for pembrolizumab to a fixed efficacy target of 5% using an exact test of binomial distribution||||<0.001
72551832|NCT01045096|144634153|SUPERIORITY_OR_OTHER||Dose Proportionality Point Estimate|1.2|||||TWO_SIDED|90.0|0.66|2.183|||ANCOVA|||Sample size of 12 participants per dose group, along with the intense PK sampling in each regimen was needed for characterization of the PK profile. An ANCOVA model with weight as a covariate and regimen as a factor were fitted to dose-normalized Cmax. Pairwise comparisons between regimens were conducted.||2.183|0.660|
72551833|NCT01045096|144634153|SUPERIORITY_OR_OTHER||Dose proportionality Point Estimate|1.06|||||TWO_SIDED|90.0|0.463|2.427|||ANCOVA|||Sample size of 12 participants per dose group, along with the intense PK sampling in each regimen was needed for characterization of the PK profile. An ANCOVA model with weight as a covariate and regimen as a factor were fitted to dose-normalized Cmax. Pairwise comparisons between regimens were conducted.||2.427|0.463|
72551834|NCT01045096|144634153|SUPERIORITY_OR_OTHER||Dose Proportionality Point Estimate|0.88|||||TWO_SIDED|90.0|0.493|1.579|||ANCOVA|||Sample size of 12 participants per dose group, along with the intense PK sampling in each regimen was needed for characterization of the PK profile. An ANCOVA model with weight as a covariate and regimen as a factor were fitted to dose-normalized Cmax. Pairwise comparisons between regimens were conducted.||1.579|0.493|
72551835|NCT01045096|144634154|SUPERIORITY_OR_OTHER||Dose Proportionality Point Estimate|1.13|||||TWO_SIDED|90.0|0.693|1.848|||ANCOVA|||Sample size of 12 participants per dose group, along with the intense PK sampling in each regimen was needed for characterization of the PK profile. An ANCOVA model with weight as a covariate and regimen as a factor were fitted to dose-normalized AUC\[0-tlqc\]. Pairwise comparisons between regimens were conducted.||1.848|0.693|
72551836|NCT01045096|144634154|SUPERIORITY_OR_OTHER||Dose Proportionality Point Estimate|1.15|||||TWO_SIDED|90.0|0.584|2.276|||ANCOVA|||Sample size of 12 participants per dose group, along with the intense PK sampling in each regimen was needed for characterization of the PK profile. An ANCOVA model with weight as a covariate and regimen as a factor were fitted to dose-normalized AUC\[0-tlqc\]. Pairwise comparisons between regimens were conducted.||2.276|0.584|
72551837|NCT01045096|144634154|SUPERIORITY_OR_OTHER||Dose Proportionality Point Estimate|1.02|||||TWO_SIDED|90.0|0.632|1.642|||ANCOVA|||Sample size of 12 participants per dose group, along with the intense PK sampling in each regimen was needed for characterization of the PK profile. An ANCOVA model with weight as a covariate and regimen as a factor were fitted to dose-normalized AUC\[0-tlqc\]. Pairwise comparisons between regimens were conducted.||1.642|0.632|
72551838|NCT01045096|144634155|SUPERIORITY_OR_OTHER||Dose Proportionality Point Estimate|1.06|||||TWO_SIDED|90.0|0.692|1.636|||ANCOVA|||Sample size of 12 participants per dose group, along with the intense PK sampling in each regimen was needed for characterization of the PK profile. An ANCOVA model with weight as a covariate and regimen as a factor were fitted to dose-normalized AUC\[0-24\]. Pairwise comparisons between regimens were conducted.||1.636|0.692|
72551839|NCT01045096|144634155|SUPERIORITY_OR_OTHER||Dose Proportionality Point Estimate|1.26|||||TWO_SIDED|90.0|0.691|2.314|||ANCOVA|||Sample size of 12 participants per dose group, along with the intense PK sampling in each regimen was needed for characterization of the PK profile. An ANCOVA model with weight as a covariate and regimen as a factor were fitted to dose-normalized AUC\[0-24\]. Pairwise comparisons between regimens were conducted.||2.314|0.691|
72551840|NCT01045096|144634155|SUPERIORITY_OR_OTHER||Dose Proportionality Point Estimate|1.19|||||TWO_SIDED|95.0|0.777|1.817|||ANCOVA|||Sample size of 12 participants per dose group, along with the intense PK sampling in each regimen was needed for characterization of the PK profile. An ANCOVA model with weight as a covariate and regimen as a factor were fitted to dose-normalized AUC\[0-24\]. Pairwise comparisons between regimens were conducted.||1.817|0.777|
72551841|NCT00324168|144634169|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.009||||0.82|TWO_SIDED|95.0|-0.085|0.068|||Regression, Linear|Adjusted for enrollment BSCVA||||0.068|-0.085|0.82
72551842|NCT00324168|144634170|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.06||||0.4|TWO_SIDED|95.0|-0.09|0.15|||Regression, Linear|||||0.15|-0.09|0.40
72551843|NCT00324168|144634171|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.01||||0.873|TWO_SIDED|95.0|-0.07|0.08|||Regression, Linear|||||0.08|-0.07|0.873
72551844|NCT00324168|144634172|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.92||||0.44|TWO_SIDED|95.0|0.76|1.12|||Regression, Cox|||||1.12|0.76|0.44
72551845|NCT00324168|144634173|SUPERIORITY_OR_OTHER||||||>|0.99||95.0|||||Fisher Exact|||||||>0.99
72584126|NCT03296527|144699108|SUPERIORITY||Mean ratio|0.83|||<|0.001|TWO_SIDED|95.0|0.77|0.89||The p-value corresponds to F-test of treatment effect.|ANCOVA|The multiplicative ANCOVA model included treatment and age stratum as fixed factors.|Mean ratio is equal to FE 999049/GONAL-F.|Circulating concentrations of Inhibin B on stimulation Day 6||0.89|0.77|<0.001
72413168|NCT01040130|144335022|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.258|STANDARD_ERROR_OF_MEAN|0.034|<|0.0001||95.0|0.191|0.325|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 5 mcg minus Placebo|||0.325|0.191|<0.0001
72551846|NCT00324168|144634174|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.04||||0.39|TWO_SIDED|95.0|-0.12|0.05|||Regression, Linear|||||0.05|-0.12|0.39
72551847|NCT00324168|144634175|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.01|STANDARD_ERROR_OF_MEAN|0.04||0.78||95.0|-0.09|0.07|||Regression, Linear|||||0.07|-0.09|0.78
72551848|NCT00324168|144634176|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.12||||0.3|TWO_SIDED|95.0|-0.011|0.35|||Regression, Linear|||Nocardia spp||0.35|-.011|0.30
72551849|NCT00324168|144634176|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.01||||0.86||95.0|-0.12|0.1|||Regression, Linear|||Streptococcus pneumoniae||0.10|-0.12|0.86
72551850|NCT00324168|144634176|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.1||||0.65|TWO_SIDED|95.0|-0.34|0.55|||Regression, Linear|||Moraxella spp||0.55|-0.34|0.65
72551851|NCT00324168|144634176|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.04||||0.67|TWO_SIDED|95.0|-0.2|0.13|||Regression, Linear|||Pseudomonas aeruginosa||0.13|-0.20|0.67
72551852|NCT00324168|144634177|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.08||||0.33|TWO_SIDED|95.0|-0.08|0.25|||Regression, Linear|||\<20/40||0.25|-0.08|0.33
72551853|NCT00324168|144634177|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.01||||0.85|TWO_SIDED|95.0|-0.09|0.11|||Regression, Linear|||20/40 to 20/800||0.11|-0.09|0.85
72551854|NCT00324168|144634177|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.17||||0.03|TWO_SIDED|95.0|-0.31|-0.02|||Regression, Linear|||CF or worse||-0.02|-0.31|0.03
72413169|NCT01040130|144335022|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.294|STANDARD_ERROR_OF_MEAN|0.035|<|0.0001||95.0|0.226|0.362|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 10 mcg minus Placebo|||0.362|0.226|<0.0001
72413170|NCT01040130|144335023|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.18|STANDARD_ERROR_OF_MEAN|0.037|<|0.0001||95.0|0.107|0.252|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 5 mcg minus Placebo|||0.252|0.107|<0.0001
72413171|NCT01040130|144335023|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.137|STANDARD_ERROR_OF_MEAN|0.037||0.0003||95.0|0.064|0.21|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 10 mcg minus Placebo|||0.210|0.064|0.0003
72413172|NCT01040130|144335024|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.103|STANDARD_ERROR_OF_MEAN|0.051||0.0447||95.0|-0.204|-0.002|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 5 mcg minus Placebo|||-0.002|-0.204|0.0447
72551855|NCT00324168|144634178|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.06||||0.31|TWO_SIDED|95.0|-0.05|0.17|||Regression, Linear|||\>0-33%||0.17|-0.05|0.31
72551856|NCT00324168|144634178|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.01||||0.94|TWO_SIDED|95.0|-0.13|0.14|||Regression, Linear|||\>33%-67%||0.14|-0.13|0.94
72584127|NCT03296527|144699109|SUPERIORITY||Mean ratio|0.87||||0.001|TWO_SIDED|95.0|0.8|0.95||The p-value corresponds to F-test of treatment effect.|ANCOVA|The multiplicative ANCOVA model included treatment and age stratum as fixed factors.|Mean ratio is equal to FE 999049/GONAL-F.|Circulating concentrations of Inhibin B at end-of-stimulation||0.95|0.80|0.001
72584128|NCT03296527|144699110|SUPERIORITY||Mean ratio|1.08|||<|0.001|TWO_SIDED|95.0|1.04|1.12||The p-value corresponds to F-test of treatment effect.|ANCOVA|The multiplicative ANCOVA model included treatment and age stratum as fixed factors.|Mean ratio is equal to FE 999049/GONAL-F.|Circulating concentrations of FSH on stimulation Day 6||1.12|1.04|<0.001
72584129|NCT03296527|144699111|SUPERIORITY||Mean ratio|0.92|||<|0.001|TWO_SIDED|95.0|0.89|0.95||The p-value corresponds to F-test of treatment effect.|ANCOVA|The multiplicative ANCOVA model included treatment and age stratum as fixed factors.|Mean ratio is equal to FE 999049/GONAL-F.|Circulating concentrations of FSH at end-of-stimulation||0.95|0.89|<0.001
72584130|NCT03296527|144699112|SUPERIORITY||Mean ratio|1.03||||0.184|TWO_SIDED|95.0|0.99|1.07||The p-value corresponds to the two-sided F-test of treatment effect.|ANCOVA|The multiplicative ANCOVA model included treatment and age stratum as fixed factors.|Mean ratio is equal to FE 999049/GONAL-F.|Circulating concentrations of FSH at oocyte retrieval visit||1.07|0.99|0.184
72584131|NCT03296527|144699113|SUPERIORITY||||||<|0.001|||||||van Elteren test|p-value is based on van Elteren test adjusted for AMH group.||Total gonadotropin dose||||<.001
72413173|NCT01040130|144335024|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.064|STANDARD_ERROR_OF_MEAN|0.052||0.2132||95.0|-0.166|0.037|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 10 mcg minus Placebo|||0.037|-0.166|0.2132
72413174|NCT01040130|144335025|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.088|STANDARD_ERROR_OF_MEAN|0.154||0.5698||95.0|-0.391|0.216|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 5 mcg minus Placebo|||0.216|-0.391|0.5698
72551857|NCT00324168|144634178|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.15||||0.07|TWO_SIDED|95.0|-0.31|0.01|||Regression, Linear|||\>67%-100%||0.01|-0.31|0.07
72584132|NCT03296527|144699115|SUPERIORITY|Treatment groups were compared using the van Elteren test.||||||0.001|||||||van Elteren|p-value is based on van Elteren test adjusted for AMH group.||Number of stimulation days||||0.001
72584133|NCT00122382|144699143|SUPERIORITY_OR_OTHER||Estimated Difference between ABA and PLA|15.1|||<|0.001|TWO_SIDED|95.0|6.0|24.2||p-value of \<0.05: probability for testing the difference between ABA and PLA.|Chi-squared, Continuity-Corrected|||Estimated Difference between ABA and PLA is the estimated difference between ABA and PLA in the proportion of subjects achieving an ACR 50 response.||24.2|6.0|<0.001
72413175|NCT01040130|144335025|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.256|STANDARD_ERROR_OF_MEAN|0.155||0.1003||95.0|-0.05|0.561|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 10 mcg minus Placebo|||0.561|-0.050|0.1003
72413176|NCT01040130|144335026|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.122|STANDARD_ERROR_OF_MEAN|0.069||0.0784||95.0|-0.258|0.014|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 5 mcg minus Placebo|||0.014|-0.258|0.0784
72551858|NCT00324168|144634179|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.05||||0.53|TWO_SIDED|95.0|-0.1|0.2|||Regression, Linear|||0-1.90 mm||0.20|-0.10|0.53
72551859|NCT00324168|144634179|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0||||0.95|TWO_SIDED|95.0|-0.15|0.16|||Regression, Linear|||1.91-2.70 mm||0.16|-0.15|0.95
72551860|NCT00324168|144634179|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.03||||0.7|TWO_SIDED|95.0|-0.12|0.18|||Regression, Linear|||2.71-4.06 mm||0.18|-0.12|0.70
72584134|NCT00122382|144699144|SUPERIORITY_OR_OTHER||Estimated Difference between ABA and PLA|15.5|||<|0.001|TWO_SIDED|95.0|8.2|22.8||p-value of \<0.05: probability for testing the difference between ABA and PLA.|Chi-squared, Continuity-Corrected|||Estimated Difference between ABA and PLA is the estimated difference between ABA and PLA in the proportion of subjects achieving MCR.||22.8|8.2|<0.001
72551861|NCT00324168|144634179|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.15||||0.07|TWO_SIDED|95.0|-0.31|0.01|||Regression, Linear|||4.07-8.90 mm||0.01|-0.31|0.07
72551862|NCT03497897|144634183|OTHER|The effects included in the model are: log transformed baseline inflammatory facial lesion count, treatment group, visit, treatment group by visit interaction, log transformed baseline inflammatory facial lesion count by visit interaction and type of center.|Posterior geometric mean ratio|0.93|||||TWO_SIDED|90.0|0.64|1.34|||Bayesian analysis|Bayesian mixed effect model with repeated measures|90% credible intervals are reported on the geometric means ratio|||1.34|0.64|
72413177|NCT01040130|144335026|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.115|STANDARD_ERROR_OF_MEAN|0.07||0.1013||95.0|-0.252|0.023|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 10 mcg minus Placebo|||0.023|-0.252|0.1013
72413178|NCT01040130|144335027|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.21|STANDARD_ERROR_OF_MEAN|0.066||0.0015||95.0|-0.339|-0.081|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 5 mcg minus Placebo|||-0.081|-0.339|0.0015
72552991|NCT02255097|144637043|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||exact binomial distribution|H0: p ≤ 0.05 versus H1: p \> 0.05||Analysis comparing the ORR for pembrolizumab to a fixed efficacy target of 5% using an exact test of binomial distribution||||<0.001
72584135|NCT00122382|144699145|SUPERIORITY_OR_OTHER||Estimate of/Adjusted Difference|-0.73|||<|0.001|TWO_SIDED|95.0|-0.98|-0.48||p-value of \<0.05: probability for testing the difference between ABA and PLA.|ANCOVA|Adjustment based on ANCOVA model with treatment as factor and baseline value as covariate.||||-0.48|-0.98|<0.001
72584136|NCT00122382|144699146|SUPERIORITY_OR_OTHER||Estimated Difference between ABA and PLA|9.8||||0.024|TWO_SIDED|95.0|1.3|18.4||p-value of \<0.05: probability for testing the difference between ABA and PLA.|Chi-squared, Continuity-Corrected|||Estimated Difference between ABA and PLA is the estimated difference between ABA and PLA in the proportion of subjects achieving HAQ response.||18.4|1.3|0.024
72584137|NCT00122382|144699147|SUPERIORITY_OR_OTHER||Estimate of/Adjusted Difference|2.5||||0.005|TWO_SIDED|95.0|0.77|4.23||p-value of \<0.05: probability for testing the difference between ABA and PLA.|ANCOVA|Adjustment based on ANCOVA model with treatment as factor and baseline value as covariate.||PCS Adjusted Mean Change from Baseline to Month 12||4.23|0.77|0.005
72584138|NCT00122382|144699147|SUPERIORITY_OR_OTHER||Estimate of/Adjusted Difference|1.81||||0.046|TWO_SIDED|95.0|0.03|3.6||p-value of \<0.05: probability for testing the difference between ABA and PLA.|ANCOVA|Adjustment based on ANCOVA model with treatment as factor and baseline value as covariate.||MCS Adjusted Mean Change from Baseline to Month 12||3.60|0.03|0.046
72584139|NCT00122382|144699148|SUPERIORITY_OR_OTHER|||||||0.033||95.0||||P-value of \<0.05: probability for comparison of change in radiographic scores between abatacept and placebo.|Nonparametric ANCOVA|||comparison of change in erosion scores between abatacept and placebo||||0.033
72584140|NCT00122382|144699148|SUPERIORITY_OR_OTHER|||||||0.353||95.0||||P-value of \<0.05: probability for comparison of change in radiographic scores between abatacept and placebo.|Nonparametric ANCOVA|||comparison of change in JSN scores between abatacept and placebo||||0.353
72584141|NCT00122382|144699150|SUPERIORITY_OR_OTHER||Estimated Difference between ABA and PLA|18.1|||<|0.001|TWO_SIDED|95.0|9.6|26.6||Total score was tested only if there was statistical significance in remission rate. For each test, the nominal type I error rate is set at 5%; this sequential testing procedure preserves the overall type I error rate at 5%.|Chi-squared, Continuity-Corrected|||Estimated Difference between ABA and PLA is the estimated difference between ABA and PLA in the proportion of subjects achieving DAS28-CRP remission.||26.6|9.6|<0.001
72584142|NCT00122382|144699151|SUPERIORITY_OR_OTHER||||||<|0.04||95.0||||Total score was tested only if there was statistical significance in remission rate. For each test, the nominal type I error rate is set at 5%; this sequential testing procedure preserves the overall type I error rate at 5%.|non-parametric ANCOVA|||||||<0.040
72584143|NCT00122382|144699166|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||signed rank test|||||||<0.001
72584144|NCT02040805|144699169|NON_INFERIORITY|Margin based on clinically meaningful change of \>= 5 points.||||||0.04|||||||t-test, 1 sided|||Test of non-inferiority.||||0.04
72584145|NCT02040805|144699170|NON_INFERIORITY|Margin based on clinically meaningful change of \>= 2.5 points.||||||0.05|||||||t-test, 1 sided|||Test of non-inferiority.||||0.05
72413179|NCT01040130|144335027|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.373|STANDARD_ERROR_OF_MEAN|0.066|<|0.0001||95.0|-0.503|-0.243|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 10 mcg minus Placebo|||-0.243|-0.503|<0.0001
72584146|NCT02040805|144699171|OTHER|linear mixed models analysis|||||<|0.0001|||||||Mixed Models Analysis|df=1||||||<0.0001
72584147|NCT02040805|144699172|OTHER|linear mixed model|||||<|0.0001|||||||Mixed Models Analysis|df=1||||||<0.0001
72584148|NCT01008605|144699173|SUPERIORITY_OR_OTHER||Lower limit, 95% one-sided CI|95.83|||||ONE_SIDED|95.0|87.46||||||||||87.46|
72584149|NCT01213966|144699180|SUPERIORITY_OR_OTHER|||||||0.01|TWO_SIDED|||||PPR24 was summarized descriptively. No statistical test was performed. The PRR24 values were summarised when the corresponding regression fit had a p-value of p ≤0.01 and an adjusted coefficient of determination (R2) ≥0.85.|Regression, Linear|||PPR24 was summarised descriptively. No statistical test was performed.||||0.01
72584150|NCT01445730|144699196|OTHER|||||||0.005|||||||Wilcoxon (Mann-Whitney)|||||||0.005
72584151|NCT01445730|144699197|OTHER|||||||0.04|||||||Wilcoxon (Mann-Whitney)|||||||0.04
72584152|NCT01445730|144699198|OTHER|||||||0.04|||||||Wilcoxon (Mann-Whitney)|||||||0.04
72584153|NCT01445730|144699199|OTHER|||||||0.005|||||||Wilcoxon (Mann-Whitney)|||||||0.005
72584154|NCT01445730|144699200|OTHER|||||||0.006|||||||Wilcoxon (Mann-Whitney)|||||||0.006
72584155|NCT01445730|144699201|OTHER|||||||0.01|||||||Wilcoxon (Mann-Whitney)|||||||0.01
72584156|NCT01445730|144699202|OTHER|||||||0.008|||||||Wilcoxon (Mann-Whitney)|||||||0.008
72584157|NCT03158038|144699286|SUPERIORITY||Rate difference|0.0|||||TWO_SIDED|95.0|-6.7|1.9||||||||1.9|-6.7|
72584158|NCT03158038|144699287|SUPERIORITY||Rate difference|1.3|||||TWO_SIDED|95.0|-12.8|13.2||||||Statistical analysis up to Day 8||13.2|-12.8|
72584159|NCT03158038|144699287|SUPERIORITY||Rate difference|0.4|||||TWO_SIDED|95.0|-14.1|13.2||||||Statistical analysis up to Day 15||13.2|-14.1|
72584160|NCT02612623|144699340|OTHER||LSM Difference|-0.56|||||TWO_SIDED|95.0|-2.08|0.96|||||Gefapixant minus Placebo|Least squares mean (LSM) difference: Mixed effect repeated measures model (MMRM) uses the change from baseline as the dependent variable, and includes the treatment group, visit day, and the interaction between treatment and visit as fixed factors, and baseline as a covariate.||0.96|-2.08|
72551863|NCT03497897|144634183|OTHER|The effects included in the model are: log transformed baseline inflammatory facial lesion count, treatment group, visit, treatment group by visit interaction, log transformed baseline inflammatory facial lesion count by visit interaction and type of center.|P(Geometric Mean Ratio<1)|0.637|||||||||||Bayesian analysis|Bayesian mixed effect model with repeated measures|Posterior probability on geometric mean ratio is reported.|||||
72551864|NCT03497897|144634183|OTHER|The effects included in the model are: log transformed baseline inflammatory facial lesion count, treatment group, visit, treatment group by visit interaction, log transformed baseline inflammatory facial lesion count by visit interaction and type of center.|P(Geometric Mean Ratio<0.75)|0.171|||||||||||Bayesian analysis|Bayesian mixed effect model with repeated measures|Posterior probability on geometric mean ratio is reported.|||||
72551865|NCT00358449|144634200|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.55||||0.865|TWO_SIDED|95.0|0.04|5.44|||Regression, Logistic|||||5.44|0.04|0.865
72551866|NCT00358449|144634200|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.21||||0.19|TWO_SIDED|95.0|0.01|2.07|||Regression, Logistic|||||2.07|0.01|0.190
72551867|NCT00358449|144634203|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.128||||0.551|TWO_SIDED|95.0|-0.303|0.56|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 9-12.|||0.560|-0.303|0.551
72551868|NCT00358449|144634203|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.12||||0.593||95.0|-0.331|0.572|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 9-12.|||0.572|-0.331|0.593
72551869|NCT00358449|144634203|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.334||||0.239|TWO_SIDED|95.0|-0.232|0.901|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 21-24.|||0.901|-0.232|0.239
72551870|NCT00358449|144634203|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.211||||0.488|TWO_SIDED|95.0|-0.401|0.823|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 21-24.|||0.823|-0.401|0.488
72551871|NCT00358449|144634204|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.356||||0.139|TWO_SIDED|95.0|-0.121|0.833|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 9-12.|||0.833|-0.121|0.139
72551872|NCT00358449|144634204|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.371||||0.145||95.0|-0.133|0.874|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 9-12.|||0.874|-0.133|0.145
72551873|NCT00358449|144634204|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.433||||0.095|TWO_SIDED|95.0|-0.08|0.946|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 21-24.|||0.946|-0.080|0.095
72551874|NCT00358449|144634204|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.343||||0.219|TWO_SIDED|95.0|-0.214|0.899|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 21-24.|||0.899|-0.214|0.219
72551875|NCT00358449|144634205|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.59||||0.832|TWO_SIDED|95.0|-13.47|16.65|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 9-12.|||16.65|-13.47|0.832
72551876|NCT00358449|144634205|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.92||||0.622|TWO_SIDED|95.0|-12.01|19.84|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 9-12.|||19.84|-12.01|0.622
72551877|NCT00358449|144634205|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.83||||0.317|TWO_SIDED|95.0|-11.86|35.52|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 21-24.|||35.52|-11.86|0.317
72551878|NCT00358449|144634205|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|15.1||||0.246|TWO_SIDED|95.0|-10.91|41.11|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 21-24.|||41.11|-10.91|0.246
72551879|NCT00358449|144634206|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|19.28||||0.046|TWO_SIDED|95.0|0.39|38.18|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 9-12.|||38.18|0.39|0.046
72551880|NCT00358449|144634206|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.21||||0.16|TWO_SIDED|95.0|-5.83|34.25|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 9-12.|||34.25|-5.83|0.160
72551881|NCT00358449|144634206|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|17.69||||0.078|TWO_SIDED|95.0|-2.1|37.48|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 21-24.|||37.48|-2.10|0.078
72551882|NCT00358449|144634206|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|21.11||||0.055|TWO_SIDED|95.0|-0.51|42.74|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 21-24.|||42.74|-0.51|0.055
72551883|NCT00358449|144634207|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.324||||0.241|TWO_SIDED|95.0|-0.226|0.873|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 9-12.|||0.873|-0.226|0.241
72551884|NCT00358449|144634207|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.26||||0.371|TWO_SIDED|95.0|-0.32|0.839|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 9-12.|||0.839|-0.320|0.371
72551885|NCT00358449|144634207|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.353||||0.291|TWO_SIDED|95.0|-0.317|1.023|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 21-24.|||1.023|-0.317|0.291
72551886|NCT00358449|144634207|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.176||||0.653|TWO_SIDED|95.0|-0.965|0.614|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 21-24.|||0.614|-0.965|0.653
72551887|NCT00358449|144634208|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.06||||0.123|TWO_SIDED|95.0|-4.0|32.13|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 9-12.|||32.13|-4.00|0.123
72551888|NCT00358449|144634208|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.62||||0.551|TWO_SIDED|95.0|-13.29|24.54|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 9-12.|||24.54|-13.29|0.551
72551889|NCT00358449|144634208|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.04||||0.141|TWO_SIDED|95.0|-5.61|37.7|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 21-24.|||37.70|-5.61|0.141
72551890|NCT00358449|144634208|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.42||||0.666|TWO_SIDED|95.0|-30.74|19.9|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 21-24.|||19.90|-30.74|0.666
72551891|NCT00358449|144634209|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.088||||0.572|TWO_SIDED|95.0|-0.224|0.4|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 9-12.|||0.400|-0.224|0.572
72413180|NCT01040130|144335028|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.119|STANDARD_ERROR_OF_MEAN|0.034||0.0005||95.0|0.052|0.185|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 5 mcg minus Placebo|||0.185|0.052|0.0005
72413181|NCT01040130|144335028|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.092|STANDARD_ERROR_OF_MEAN|0.034||0.0073||95.0|0.025|0.159|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 10 mcg minus Placebo|||0.159|0.025|0.0073
72413182|NCT01040130|144335029|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.206|STANDARD_ERROR_OF_MEAN|0.035|<|0.0001||95.0|0.136|0.275|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 5 mcg minus Placebo|||0.275|0.136|<0.0001
72551892|NCT00358449|144634209|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.012||||0.942|TWO_SIDED|95.0|-0.35|0.326|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 9-12.|||0.326|-0.350|0.942
72551893|NCT00358449|144634209|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.005||||0.96|TWO_SIDED|95.0|-0.188|0.197|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 21-24.|||0.197|-0.188|0.960
72551894|NCT00358449|144634209|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.105||||0.317|TWO_SIDED|95.0|-0.105|0.315|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 21-24.|||0.315|-0.105|0.317
72551895|NCT00358449|144634210|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.13||||0.666|TWO_SIDED|95.0|-6.39|4.12|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 9-12.|||4.12|-6.39|0.666
72551896|NCT00358449|144634210|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.16||||0.45|TWO_SIDED|95.0|-7.87|3.56|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 9-12.|||3.56|-7.87|0.450
72551897|NCT00358449|144634210|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.6||||0.215|TWO_SIDED|95.0|-12.0|2.81|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 21-24.|||2.81|-12.00|0.215
72551898|NCT00358449|144634210|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.51||||0.898|TWO_SIDED|95.0|-8.61|7.58|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 21-24.|||7.58|-8.61|0.898
72413183|NCT01040130|144335029|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.216|STANDARD_ERROR_OF_MEAN|0.036|<|0.0001||95.0|0.146|0.285|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 10 mcg minus Placebo|||0.285|0.146|<0.0001
72413184|NCT01040130|144335030|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.006|STANDARD_ERROR_OF_MEAN|0.062||0.9239||95.0|-0.115|0.127|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 5 mcg minus Placebo|||0.127|-0.115|0.9239
72413185|NCT01040130|144335030|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.021|STANDARD_ERROR_OF_MEAN|0.062||0.7368||95.0|-0.144|0.102|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 10 mcg minus Placebo|||0.102|-0.144|0.7368
72551899|NCT00358449|144634211|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.038||||0.762|TWO_SIDED|95.0|-0.217|0.294|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 9-12.|||0.294|-0.217|0.762
72551900|NCT00358449|144634211|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.159||||0.235|TWO_SIDED|95.0|-0.426|0.108|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 9-12.|||0.108|-0.426|0.235
72551901|NCT00358449|144634211|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.089||||0.607|TWO_SIDED|95.0|-0.259|0.436|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 21-24.|||0.436|-0.259|0.607
72551902|NCT00358449|144634211|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.068||||0.716|TWO_SIDED|95.0|-0.308|0.443|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 21-24.|||0.443|-0.308|0.716
72413186|NCT01040130|144335031|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.014|STANDARD_ERROR_OF_MEAN|0.067||0.8302||95.0|-0.146|0.118|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 5 mcg minus Placebo|||0.118|-0.146|0.8302
72413187|NCT01040130|144335031|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.159|STANDARD_ERROR_OF_MEAN|0.068||0.0202||95.0|-0.292|-0.025|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 10 mcg minus Placebo|||-0.025|-0.292|0.0202
72551903|NCT00358449|144634212|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.09||||0.691|TWO_SIDED|95.0|-0.365|0.545|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 9-12.|||0.545|-0.365|0.691
72551904|NCT00358449|144634212|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.161||||0.5|TWO_SIDED|95.0|-0.639|0.317|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 9-12.|||0.317|-0.639|0.500
72551905|NCT00358449|144634212|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.187||||0.568|TWO_SIDED|95.0|-0.474|0.849|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 21-24.|||0.849|-0.474|0.568
72551906|NCT00358449|144634212|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.076||||0.832|TWO_SIDED|95.0|-0.643|0.794|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 21-24.|||0.794|-0.643|0.832
72551907|NCT00358449|144634213|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.85||||0.515|TWO_SIDED|95.0|-3.45|1.76|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 9-12.|||1.76|-3.45|0.515
72551908|NCT00358449|144634213|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.9||||0.496|TWO_SIDED|95.0|-1.74|3.54|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 9-12.|||3.54|-1.74|0.496
72551909|NCT00358449|144634213|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.05||||0.657|TWO_SIDED|95.0|-5.82|3.72|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 21-24.|||3.72|-5.82|0.657
72551910|NCT00358449|144634213|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.01||||0.691|TWO_SIDED|95.0|-6.11|4.09|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 21-24.|||4.09|-6.11|0.691
72551911|NCT00358449|144634214|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3||||0.142|TWO_SIDED|95.0|-0.105|0.704|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 9-12.|||0.704|-0.105|0.142
72551912|NCT00358449|144634214|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.354||||0.115|TWO_SIDED|95.0|-0.09|0.798|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 9-12.|||0.798|-0.090|0.115
72551913|NCT00358449|144634214|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.182||||0.465|TWO_SIDED|95.0|-0.319|0.683|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 21-24.|||0.683|-0.319|0.465
72551914|NCT00358449|144634214|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.121||||0.649|TWO_SIDED|95.0|-0.417|0.66|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 21-24.|||0.660|-0.417|0.649
72551915|NCT00358449|144634215|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.37||||0.077|TWO_SIDED|95.0|-0.042|0.782|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 9-12.|||0.782|-0.042|0.077
72584161|NCT02612623|144699340|OTHER||LSM Difference|-0.71|||||TWO_SIDED|95.0|-2.34|0.92|||||Gefapixant minus Placebo|LSM difference: MMRM uses the change from baseline as the dependent variable, and includes the treatment group, visit day, and the interaction between treatment and visit as fixed factors, and baseline as a covariate.||0.92|-2.34|
72584162|NCT02612623|144699340|OTHER||LSM Difference|-1.35|||||TWO_SIDED|95.0|-2.99|0.3|||||Gefapixant minus Placebo|LSM difference: MMRM uses the change from baseline as the dependent variable, and includes the treatment group, visit day, and the interaction between treatment and visit as fixed factors, and baseline as a covariate.||0.30|-2.99|
72584163|NCT02612623|144699340|OTHER||Percentage Change|-42.6|||||TWO_SIDED|95.0|-87.5|162.3|||||100 x \[(Exponent of LSM Difference) minus 1\]|Estimated Percentage Change: MMRM uses the change from baseline as the dependent variable, and includes the treatment group, visit day, and the interaction between treatment and visit as fixed factors, and baseline as a covariate.||162.3|-87.5|
72584164|NCT02612623|144699340|OTHER||Percentage Change|-50.8|||||TWO_SIDED|95.0|-90.3|151.1|||||100 x \[(Exponent of LSM Difference) minus 1\]|Estimated Percentage Change: MMRM uses the change from baseline as the dependent variable, and includes the treatment group, visit day, and the interaction between treatment and visit as fixed factors, and baseline as a covariate.||151.1|-90.3|
72584165|NCT02612623|144699340|OTHER||Percentage Change|-74.0|||||TWO_SIDED|95.0|-95.0|34.7|||||100 x \[(Exponent of LSM Difference) minus 1\]|Estimated Percentage Change: MMRM uses the change from baseline as the dependent variable, and includes the treatment group, visit day, and the interaction between treatment and visit as fixed factors, and baseline as a covariate.||34.7|-95.0|
72413188|NCT01040130|144335032|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.089|STANDARD_ERROR_OF_MEAN|0.017|<|0.0001||95.0|0.056|0.123|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 5 mcg minus Placebo|||0.123|0.056|<0.0001
72584166|NCT00607620|144699404|SUPERIORITY||Risk Ratio (RR)|0.88|||||TWO_SIDED|95.0|0.79|0.98||||||||0.98|0.79|
72584167|NCT00607620|144699405|SUPERIORITY||Mean Difference (Net)|-1.2|||||TWO_SIDED|95.0|-2.1|-0.3|||||The data represented refers to the group mean difference (intervention versus control) of the change score between baseline to 12-months.|||-0.3|-2.1|
72584168|NCT00607620|144699406|SUPERIORITY||Mean Difference (Net)|3.4|||||TWO_SIDED|95.0|0.4|6.4|||||The data represented refers to the group mean difference (intervention versus control) of the change score between 6-months and 12-months.|||6.4|0.4|
72584169|NCT00607620|144699407|SUPERIORITY||Mean Difference (Net)|-0.7|||||TWO_SIDED|95.0|-3.3|1.9|||||The data represented refers to the group mean difference (intervention versus control) of the change score between 6-months and 12-months.|||1.9|-3.3|
72584170|NCT00607620|144699408|SUPERIORITY||Mean Difference (Net)|-0.01|||||TWO_SIDED|95.0|-1.02|0.99|||||The data represented refers to the group mean difference (intervention versus control) of the change score between 6-months and 12-months.|||0.99|-1.02|
72584171|NCT01620138|144699409|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<0.05
72413189|NCT01040130|144335032|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.101|STANDARD_ERROR_OF_MEAN|0.017|<|0.0001||95.0|0.068|0.134|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 10 mcg minus Placebo|||0.134|0.068|<0.0001
72551916|NCT00358449|144634215|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.356||||0.12|TWO_SIDED|95.0|-0.097|0.809|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 9-12.|||0.809|-0.097|0.120
72551917|NCT00358449|144634215|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.29||||0.345|TWO_SIDED|95.0|-0.326|0.906|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 21-24.|||0.906|-0.326|0.345
72551918|NCT00358449|144634215|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.128||||0.7|TWO_SIDED|95.0|-0.541|0.798|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 21-24.|||0.798|-0.541|0.700
72584172|NCT03907488|144699415|SUPERIORITY||||||<|0.005||||||One sided P-value|Log Rank|||The primary analysis of PFS used a stratified log rank test statistic and is reported as two-sided test. Stratified Cox regression was used to estimate treatment hazard ratios for treatment effect. 95% two-sided intervals are reported. The Kaplan-Meier method was used to estimate PFS curves.||||<0.005
72413190|NCT01040130|144335033|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.224|STANDARD_ERROR_OF_MEAN|0.017|<|0.0001||95.0|0.191|0.258|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 5 mcg minus Placebo|||0.258|0.191|<0.0001
72584173|NCT01766076|144699425|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|28.0|||<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|Mann Whitney test was used for nonparametric variables||||||<0.05
72584174|NCT03655405|144699457|SUPERIORITY||Incidence Rate Ratio|0.972||||0.723|TWO_SIDED|95.0|0.83|1.138|||Regression, Poisson|Number of PIMs at follow-up, adjusted for baseline value||||1.138|0.830|0.723
72584175|NCT03655405|144699458|SUPERIORITY||Incidence Rate Ratio|0.763||||0.033|TWO_SIDED|95.0|0.594|0.979|||Regression, Poisson|Number of potentially inappropriate DDD at follow-up, adjusted for baseline value||||0.979|0.594|0.033
72413191|NCT01040130|144335033|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.226|STANDARD_ERROR_OF_MEAN|0.017|<|0.0001||95.0|0.193|0.259|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 10 mcg minus Placebo|||0.259|0.193|<0.0001
72413192|NCT01040130|144335034|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.107|STANDARD_ERROR_OF_MEAN|0.031||0.0006||95.0|0.046|0.167|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 5 mcg minus Placebo|||0.167|0.046|0.0006
72413193|NCT01040130|144335034|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.098|STANDARD_ERROR_OF_MEAN|0.031||0.0017||95.0|0.037|0.158|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 10 mcg minus Placebo|||0.158|0.037|0.0017
72551919|NCT00358449|144634216|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.79||||0.609|TWO_SIDED|95.0|-8.79|5.22|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 9-12.|||5.22|-8.79|0.609
72551920|NCT00358449|144634216|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.59||||0.882|TWO_SIDED|95.0|-8.55|7.38|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 9-12.|||7.38|-8.55|0.882
72551921|NCT00358449|144634216|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.6||||0.595|TWO_SIDED|95.0|-7.68|4.47|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 21-24.|||4.47|-7.68|0.595
72551922|NCT00358449|144634216|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.45||||0.895|TWO_SIDED|95.0|-7.34|6.44|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 21-24.|||6.44|-7.34|0.895
72551923|NCT00358449|144634217|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.513||||0.062|TWO_SIDED|95.0|-0.028|1.055|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 9-12.|||1.055|-0.028|0.062
72551924|NCT00358449|144634217|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.241||||0.425|TWO_SIDED|95.0|-0.369|0.852|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 9-12.|||0.852|-0.369|0.425
72584176|NCT03655405|144699459|SUPERIORITY||Incidence Rate Ratio|0.915||||0.064|TWO_SIDED|95.0|0.834|1.005|||Regression, Poisson|Number of chronic drugs at follow-up, adjusted for baseline value||||1.005|0.834|0.064
72584177|NCT03655405|144699460|SUPERIORITY||Incidence Rate Ratio|1.019||||0.857|TWO_SIDED|95.0|0.833|1.246|||Regression, Poisson|Number of chronic drugs at follow-up, adjusted for baseline value||||1.246|0.833|0.857
72413194|NCT01040130|144335035|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.285|STANDARD_ERROR_OF_MEAN|0.029|<|0.0001||95.0|0.227|0.342|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 5 mcg minus Placebo|||0.342|0.227|<0.0001
72413195|NCT01040130|144335035|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.29|STANDARD_ERROR_OF_MEAN|0.029|<|0.0001||95.0|0.233|0.348|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 10 mcg minus Placebo|||0.348|0.233|<0.0001
72413196|NCT01040130|144335036|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.318|STANDARD_ERROR_OF_MEAN|0.056|<|0.0001||95.0|0.207|0.429|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 5 mcg minus Placebo|||0.429|0.207|<0.0001
72413197|NCT01040130|144335036|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.303|STANDARD_ERROR_OF_MEAN|0.056|<|0.0001||95.0|0.192|0.414|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 10 mcg minus Placebo|||0.414|0.192|<0.0001
72413198|NCT01040130|144335037|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.585|STANDARD_ERROR_OF_MEAN|0.063|<|0.0001||95.0|0.47|0.701|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 5 mcg minus Placebo|||0.701|0.470|<0.0001
72551925|NCT00358449|144634217|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.71||||0.082|TWO_SIDED|95.0|-0.096|1.516|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 21-24.|||1.516|-0.096|0.082
72551926|NCT00358449|144634217|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.25||||0.564|TWO_SIDED|95.0|-0.631|1.132|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 21-24.|||1.132|-0.631|0.564
72551927|NCT00358449|144634218|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.45||||0.27|TWO_SIDED|95.0|-7.77|26.67|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 9-12.|||26.67|-7.77|0.270
72551928|NCT00358449|144634218|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.12||||0.664|TWO_SIDED|95.0|-15.11|23.36|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 21-24.|||23.36|-15.11|0.664
72584178|NCT03655405|144699462|SUPERIORITY||Slope|-1.36||||0.769|TWO_SIDED|95.0|-10.6|7.89|||Regression, Linear|Scale value at follow-up, adjusted for baseline value||Analysis for the scale component||7.89|-10.60|0.769
72551929|NCT00358449|144634218|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.57||||0.381|TWO_SIDED|95.0|-13.81|34.94|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 21-24.|||34.94|-13.81|0.381
72551930|NCT00358449|144634218|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.49||||0.672|TWO_SIDED|95.0|-20.87|31.86|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 21-24.|||31.86|-20.87|0.672
72551931|NCT00358449|144634219|SUPERIORITY_OR_OTHER|||||||0.4||95.0|||||Cochran-Mantel-Haenszel|||||||0.400
72551932|NCT00358449|144634219|SUPERIORITY_OR_OTHER|||||||0.111||95.0|||||Cochran-Mantel-Haenszel|||||||0.111
72551933|NCT00358449|144634220|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-18.3||||0.421|TWO_SIDED|95.0|-71.1|34.4|||van Elteren test||P-value, 95% CI, and Estimated value are presented for Change from Baseline at Week 12|||34.4|-71.1|0.421
72551934|NCT00358449|144634220|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.1||||0.633|TWO_SIDED|95.0|-44.6|40.5|||van Elteren test||P-value, 95% CI, and Estimated value are presented for Change from Baseline at Week 12|||40.5|-44.6|0.633
72551935|NCT00358449|144634220|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.3||||0.92|TWO_SIDED|95.0|-76.3|45.7|||van Elteren test||P-value, 95% CI, and Estimated value are presented for Change from Baseline at Week 24|||45.7|-76.3|0.920
72551936|NCT00358449|144634220|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-33.8||||0.105|TWO_SIDED|95.0|-79.2|11.6|||van Elteren test||P-value, 95% CI, and Estimated value are presented for Change from Baseline at Week 24|||11.6|-79.2|0.105
72584179|NCT03655405|144699462|SUPERIORITY||Slope|-0.096||||0.075|TWO_SIDED|95.0|-0.202|0.01|||Regression, Linear|Scale value at follow-up, adjusted for baseline value||Analysis for the index component||0.01|-0.202|0.075
72413199|NCT01040130|144335037|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.618|STANDARD_ERROR_OF_MEAN|0.059|<|0.0001||95.0|0.502|0.734|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 10 mcg minus Placebo|||0.734|0.502|<0.0001
72551937|NCT00358449|144634221|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.63||||0.747|TWO_SIDED|95.0|-20.68|15.41|||van Elteren test||P-value, 95% CI, and Estimated value are presented for change from baseline values at Week 12|||15.41|-20.68|0.747
72413200|NCT02504294|144335063|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was concluded since the lower bound of the 95% CI of the difference in percentage was greater than the non-inferiority margin (-12.5%).|Difference in Percentage|-1.3975|||||TWO_SIDED|95.0|-7.6503|4.8553||||||Clustered binomial analysis using logistic regression method was performed and generalized estimating equation method was used to construct 95 percent (%) two-sided confidence intervals (CIs).||4.8553|-7.6503|
72413201|NCT02504294|144335064|SUPERIORITY_OR_OTHER||LS Mean Difference|-1062.0|STANDARD_ERROR_OF_MEAN|803.95||0.1874|TWO_SIDED|95.0|-2643.2|519.2|||ANCOVA|||P-value was calculated using analysis of covariance (ANCOVA) model with treatment as factor and baseline ESA dose as covariate.||519.2|-2643.2|0.1874
72584180|NCT03655405|144699463|SUPERIORITY||Incidence Rate Ratio|1.237||||0.212|TWO_SIDED|95.0|0.886|1.727|||Mixed-effect regression, Poisson|Number at follow-up, adjusted for baseline value||||1.727|0.886|0.212
72584181|NCT03655405|144699464|SUPERIORITY||p-value|0.675||||0.675|TWO_SIDED||||||Fisher Exact|||||||0.675
72584182|NCT03655405|144699465|SUPERIORITY||p-value|0.615||||0.615|TWO_SIDED||||||Fisher Exact|||||||0.615
72584183|NCT03655405|144699466|SUPERIORITY||p-value|0.366||||0.366|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.366
72584184|NCT03655405|144699467|SUPERIORITY||p-value|0.738||||0.738|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.738
72584185|NCT03655405|144699468|SUPERIORITY||p-value|0.781||||0.781|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.781
72584186|NCT03655405|144699469|SUPERIORITY||p-value|0.958||||0.958|TWO_SIDED||||||Fisher Exact|||||||0.958
72584187|NCT03655405|144699470|SUPERIORITY||p-value|0.911||||0.911|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.911
72584188|NCT01465412|144699504|NON_INFERIORITY_OR_EQUIVALENCE|To be considered equivalent the least squares mean (LSM) Ratio (HI/Healthy) is contained within the interval \[0.50, 2.00\].|LSM Ratio|1.075|||||TWO_SIDED|90.0|0.695|1.662||||||The analysis was performed using an analysis of covariance (ANCOVA) model. Parameters were log-transformed (using the natural logarithm) prior to analysis. Study population (i.e., HI or Healthy) was included as a fixed effect with continuous covariates age, Body Mass Index (BMI) and a categorical covariate, gender. Gender was excluded from Part 1 analysis.||1.662|0.695|
72584189|NCT01465412|144699504|NON_INFERIORITY_OR_EQUIVALENCE|To be considered equivalent the LSM Ratio (HI/Healthy) is contained within the interval \[0.50, 2.00\].|LSM Ratio|2.598|||||TWO_SIDED|90.0|1.334|5.06||||||The analysis was performed using an ANCOVA model. Parameters were log-transformed (using the natural logarithm) prior to analysis. Study population (i.e., HI or Healthy) was included as a fixed effect with continuous covariates age, BMI and a categorical covariate, gender. Gender was included from Part 2 analysis.||5.060|1.334|
72584190|NCT01465412|144699505|NON_INFERIORITY_OR_EQUIVALENCE|To be considered equivalent the LSM Ratio (HI/Healthy) is contained within the interval \[0.50, 2.00\].|LSM Ratio|1.305|||||TWO_SIDED|90.0|0.84|2.027||||||The analysis was performed using an ANCOVA model. Parameters were log-transformed (using the natural logarithm) prior to analysis. Study population (i.e., HI or Healthy) was included as a fixed effect with continuous covariates age, BMI and a categorical covariate, gender. Gender was excluded from Part 1 analysis.||2.027|0.840|
72413202|NCT00366626|144335072|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.92|STANDARD_DEVIATION|6.32||0.51|TWO_SIDED|95.0|-1.85|3.69|||ANOVA|||This was a 2 gene (asn40asn vs 40asp) by two medication (naltrexone vs placebo) design. The main hypothesis was that the effect of naltrexone (mean naltrexone drinking - placebo drinking) would be greater in the 40asp subjects than in the asn40asn subjects. Thus the null hypothesis there would be no gene by medication interaction. The mean difference above is then the difference in the size of the naltrexone effect in the two genotypes, equivalent to the interaction.||3.69|-1.85|0.51
72584191|NCT01465412|144699505|NON_INFERIORITY_OR_EQUIVALENCE|To be considered equivalent the LSM Ratio (HI/Healthy) is contained within the interval \[0.50, 2.00\].|LSM Ratio|1.434|||||TWO_SIDED|90.0|0.643|3.198||||||The analysis was performed using an ANCOVA model. Parameters were log-transformed (using the natural logarithm) prior to analysis. Study population (i.e., HI or Healthy) was included as a fixed effect with continuous covariates age, BMI and a categorical covariate, gender. Gender was included from Part 2 analysis.||3.198|0.643|
72584192|NCT01465412|144699506|NON_INFERIORITY_OR_EQUIVALENCE|To be considered equivalent the LSM Ratio (HI/Healthy) is contained within the interval \[0.50, 2.00\].|LSM Ratio|1.852|||||TWO_SIDED|90.0|0.81|4.234||||||The analysis was performed using an ANCOVA model. Parameters were log-transformed (using the natural logarithm) prior to analysis. Study population (i.e., HI or Healthy) was included as a fixed effect with continuous covariates age, BMI and a categorical covariate, gender. Gender was excluded from Part 1 analysis.||4.234|0.810|
72584193|NCT01465412|144699506|NON_INFERIORITY_OR_EQUIVALENCE|To be considered equivalent the LSM Ratio (HI/Healthy) is contained within the interval \[0.50, 2.00\].|LSM Ratio|2.392|||||TWO_SIDED|90.0|1.306|4.382||||||The analysis was performed using an ANCOVA model. Parameters were log-transformed (using the natural logarithm) prior to analysis. Study population (i.e., HI or Healthy) was included as a fixed effect with continuous covariates age, BMI and a categorical covariate, gender. Gender was included from Part 2 analysis.||4.382|1.306|
72584194|NCT01465412|144699507|NON_INFERIORITY_OR_EQUIVALENCE|To be considered equivalent the LSM Ratio (HI/Healthy) is contained within the interval \[0.50, 2.00\].|LSM Ratio|1.548|||||TWO_SIDED|90.0|0.918|2.61||||||The analysis was performed using an ANCOVA model. Parameters were log-transformed (using the natural logarithm) prior to analysis. Study population (i.e., HI or Healthy) was included as a fixed effect with continuous covariates age, BMI and a categorical covariate, gender. Gender was excluded from Part 1 analysis.||2.610|0.918|
72584195|NCT01465412|144699507|NON_INFERIORITY_OR_EQUIVALENCE|To be considered equivalent the LSM Ratio (HI/Healthy) is contained within the interval \[0.50, 2.00\].|LSM Ratio|1.407|||||TWO_SIDED|90.0|0.72|2.75||||||The analysis was performed using an ANCOVA model. Parameters were log-transformed (using the natural logarithm) prior to analysis. Study population (i.e., HI or Healthy) was included as a fixed effect with continuous covariates age, BMI and a categorical covariate, gender. Gender was included from Part 2 analysis.||2.750|0.720|
72584196|NCT01465412|144699508|NON_INFERIORITY_OR_EQUIVALENCE|To be considered equivalent the LSM Ratio (HI/Healthy) is contained within the interval \[0.50, 2.00\].|LSM Ratio|1.555|||||TWO_SIDED|90.0|0.617|3.917||||||The analysis was performed using an ANCOVA model. Parameters were log-transformed (using the natural logarithm) prior to analysis. Study population (i.e., HI or Healthy) was included as a fixed effect with continuous covariates age, BMI and a categorical covariate, gender. Gender was excluded from Part 1 analysis.||3.917|0.617|
72413203|NCT00366626|144335073|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.46|STANDARD_DEVIATION|6.1||0.28|TWO_SIDED|95.0|-1.22|4.11|||ANOVA|||This was a 2 gene (asn40asn vs 40asp) by 2 medication (naltrexone vs. placebo)interaction analysis. The main hypothesis was that subjects who had 40asp OPRM1 allele would a greater naltrexone effect on drinking (Placebo - Naltrexxone) than the asn40asn subjects. Thus the null hypothesis was the gene by medication interaction.||4.11|-1.22|0.28
72413204|NCT02255175|144335074|SUPERIORITY|||||||0.62|||||||t-test, 2 sided|t=.501, df=33||||||.620
72413205|NCT02255175|144335075|SUPERIORITY|||||||0.855|||||||t-test, 2 sided|t=.185, df=33||||||.855
72413206|NCT02255175|144335076|SUPERIORITY|||||||0.758|||||||t-test, 2 sided|t=-.310, df=33||||||.758
72413207|NCT02255175|144335077|SUPERIORITY|||||||0.518|||||||t-test, 2 sided|t=.653, df=33||||||.518
72413208|NCT02255175|144335078|SUPERIORITY|||||||0.645|||||||t-test, 2 sided|t=.465, df=33||||||.645
72413209|NCT02255175|144335079|SUPERIORITY|||||||0.015|||||||t-test, 2 sided|t=2.56, df=33||||||.015
72413210|NCT02255175|144335080|SUPERIORITY|||||||0.486|||||||t-test, 2 sided|t=.705, df=33||||||.486
72413211|NCT02255175|144335081|SUPERIORITY|||||||0.831|||||||t-test, 2 sided|t=.216, df=33||||||.831
72584197|NCT01465412|144699508|NON_INFERIORITY_OR_EQUIVALENCE|To be considered equivalent the LSM Ratio (HI/Healthy) is contained within the interval \[0.50, 2.00\].|LSM Ratio|4.806|||||TWO_SIDED|90.0|2.77|8.335||||||The analysis was performed using an ANCOVA model. Parameters were log-transformed (using the natural logarithm) prior to analysis. Study population (i.e., HI or Healthy) was included as a fixed effect with continuous covariates age, BMI and a categorical covariate, gender. Gender was included from Part 2 analysis.||8.335|2.770|
72584198|NCT01465412|144699509|NON_INFERIORITY_OR_EQUIVALENCE|To be considered equivalent the LSM Ratio (HI/Healthy) is contained within the interval \[0.50, 2.00\].|LSM Ratio|1.269|||||TWO_SIDED|90.0|0.703|2.288||||||The analysis was performed using an ANCOVA model. Parameters were log-transformed (using the natural logarithm) prior to analysis. Study population (i.e., HI or Healthy) was included as a fixed effect with continuous covariates age, BMI and a categorical covariate, gender. Gender was excluded from Part 1 analysis.||2.288|0.703|
72413212|NCT02255175|144335082|SUPERIORITY|||||||0.0002|||||||Repeated measures ANOVA|F(1,33)=17.91||||||.0002
72584199|NCT01465412|144699509|NON_INFERIORITY_OR_EQUIVALENCE|To be considered equivalent the LSM Ratio (HI/Healthy) is contained within the interval \[0.50, 2.00\].|LSM Ratio|1.98|||||TWO_SIDED|90.0|1.316|2.977||||||The analysis was performed using an ANCOVA model. Parameters were log-transformed (using the natural logarithm) prior to analysis. Study population (i.e., HI or Healthy) was included as a fixed effect with continuous covariates age, BMI and a categorical covariate, gender. Gender was included from Part 2 analysis.||2.977|1.316|
72584200|NCT01465412|144699510|NON_INFERIORITY_OR_EQUIVALENCE|To be considered equivalent the LSM Ratio (HI/Healthy) is contained within the interval \[0.50, 2.00\].|LSM Ratio|1.326|||||TWO_SIDED|90.0|0.749|2.348||||||The analysis was performed using an ANCOVA model. Parameters were log-transformed (using the natural logarithm) prior to analysis. Study population (i.e., HI or Healthy) was included as a fixed effect with continuous covariates age, BMI and a categorical covariate, gender. Gender was excluded from Part 1 analysis.||2.348|0.749|
72584201|NCT01465412|144699510|NON_INFERIORITY_OR_EQUIVALENCE|To be considered equivalent the LSM Ratio (HI/Healthy) is contained within the interval \[0.50, 2.00\].|LSM Ratio|4.041|||||TWO_SIDED|90.0|1.46|11.187||||||The analysis was performed using an ANCOVA model. Parameters were log-transformed (using the natural logarithm) prior to analysis. Study population (i.e., HI or Healthy) was included as a fixed effect with continuous covariates age, BMI and a categorical covariate, gender. Gender was included from Part 2 analysis.||11.187|1.460|
72584202|NCT01465412|144699511|NON_INFERIORITY_OR_EQUIVALENCE|To be considered equivalent the LSM Ratio (HI/Healthy) is contained within the interval \[0.50, 2.00\].|LSM Ratio|1.609|||||TWO_SIDED|90.0|1.007|2.572||||||The analysis was performed using an ANCOVA model. Parameters were log-transformed (using the natural logarithm) prior to analysis. Study population (i.e., HI or Healthy) was included as a fixed effect with continuous covariates age, BMI and a categorical covariate, gender. Gender was excluded from Part 1 analysis.||2.572|1.007|
72413213|NCT00167544|144335100|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.4|||<|0.05|TWO_SIDED|95.0|-19.49|30.29|||ANCOVA|||The primary analysis of total brain tissue volume was performed using multiple linear regression controlling for postmenstrual age at MRI scan to adjust for differences in timing at MRI. The distributions of potentially important confounding variables at baseline were compared in the two groups using parametric and non-parametric tests as appropriate. All analyses were performed using STATA 11.0. Please see PubMed: 23140612.||30.29|-19.49|<0.05
72413214|NCT01156701|144335143|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.15|||||TWO_SIDED|95.0|-1.42|1.12|||||Direct effect of Zanamivir prophylaxis on influenza risk|||1.12|-1.42|
72413215|NCT01156701|144335143|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.38|||||TWO_SIDED|95.0|-0.93|0.17|||||Total effect of zanamivir prophylaxis|||0.17|-0.93|
72413216|NCT01156701|144335143|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.14|||||TWO_SIDED|95.0|-0.75|0.47|||||Direct effect of zanamivir prophylaxis when index is treated|||0.47|-0.75|
72413217|NCT01156701|144335143|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.23|||||TWO_SIDED|95.0|-1.15|1.62|||||Risk in cohort 1 minus risk in cohort 2|||1.62|-1.15|
72413218|NCT01156701|144335143|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.24|||||TWO_SIDED|95.0|-0.51|0.03|||||Protective effect of zanamivir on susceptible risk|||0.03|-0.51|
72413219|NCT01156701|144335143|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.0|||||TWO_SIDED|95.0|0.99|1.01|||||Direct effect of Zanamivir prophylaxis on influenza risk|||1.01|0.99|
72413220|NCT01156701|144335143|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.0|||||TWO_SIDED|95.0|0.99|1.0|||||Total effect of zanamivir prophylaxis|||1.00|0.99|
72413221|NCT01156701|144335143|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.0|||||TWO_SIDED|95.0|0.99|1.0|||||Direct effect of zanamivir prophylaxis when index is treated|||1.00|0.99|
72413222|NCT01156701|144335143|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.0|||||TWO_SIDED|95.0|0.99|1.02|||||Risk in cohort 1 minus risk in cohort 2|||1.02|0.99|
72413223|NCT01156701|144335143|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.0|||||TWO_SIDED|95.0|0.99|1.0|||||Protective effect of zanamivir on susceptible risk|||1.00|0.99|
72413224|NCT01156701|144335144|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.4|||||TWO_SIDED|95.0|-1.17|0.36|||||Direct effect of Zanamivir prophylaxis on asthma risk|||0.36|-1.17|
72413225|NCT01156701|144335144|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.38|||||TWO_SIDED|95.0|-0.8|0.03|||||Total effect of zanamivir prophylaxis|||0.03|-0.80|
72413226|NCT01156701|144335144|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.28|||||TWO_SIDED|95.0|-0.75|0.18|||||Direct effect of zanamivir prophylaxis when index is treated|||0.18|-0.75|
72413227|NCT01156701|144335144|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.02|||||TWO_SIDED|95.0|-0.89|0.85|||||Risk in cohort 1 minus risk in cohort 2|||0.85|-0.89|
72413228|NCT01156701|144335144|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.1|||||TWO_SIDED|95.0|-0.31|0.11|||||Protective effect of zanamivir on susceptible risk|||0.11|-0.31|
72413229|NCT01156701|144335144|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.0|||||TWO_SIDED|95.0|0.99|1.0|||||Direct effect of Zanamivir prophylaxis on asthma risk|||1.00|0.99|
72413230|NCT01156701|144335144|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.0|||||TWO_SIDED|95.0|0.99|1.0|||||Total effect of zanamivir prophylaxis|||1.00|0.99|
72413231|NCT01156701|144335144|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.0|||||TWO_SIDED|95.0|0.99|1.0|||||Direct effect of zanamivir prophylaxis when index is treated|||1.00|0.99|
72413232|NCT01156701|144335144|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.0|||||TWO_SIDED|95.0|0.99|1.01|||||Risk in cohort 1 minus risk in cohort 2|||1.01|0.99|
72413233|NCT01156701|144335144|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.0|||||TWO_SIDED|95.0|1.0|1.0|||||Protective effect of zanamivir on susceptible risk|||1.00|1.00|
72413234|NCT01156701|144335145|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.46|||||TWO_SIDED|95.0|-0.61|1.54|||||Direct effect of Zanamivir prophylaxis on pneumonia risk|||1.54|-0.61|
72413235|NCT01156701|144335145|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.25|||||TWO_SIDED|95.0|-0.45|-0.04|||||Total effect of zanamivir prophylaxis|||-0.04|-0.45|
72413236|NCT01156701|144335145|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.15|||||TWO_SIDED|95.0|-0.39|0.09|||||Direct effect of zanamivir prophylaxis when index is treated|||0.09|-0.39|
72413237|NCT01156701|144335145|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.72|||||TWO_SIDED|95.0|-0.38|1.81|||||Risk in cohort 1 minus risk in cohort 2|||1.81|-0.38|
72413238|NCT01156701|144335145|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.1|||||TWO_SIDED|95.0|-0.22|0.02|||||Protective effect of zanamivir on susceptible risk|||0.02|-0.22|
72413239|NCT01156701|144335145|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.0|||||TWO_SIDED|95.0|0.99|1.02|||||Direct effect of Zanamivir prophylaxis on pneumonia risk|||1.02|0.99|
72413240|NCT01156701|144335145|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.0|||||TWO_SIDED|95.0|1.0|1.0|||||Total effect of zanamivir prophylaxis|||1.00|1.00|
72413241|NCT01156701|144335145|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.0|||||TWO_SIDED|95.0|1.0|1.0|||||Direct effect of zanamivir prophylaxis when index is treated|||1.00|1.00|
72584203|NCT01465412|144699511|NON_INFERIORITY_OR_EQUIVALENCE|To be considered equivalent the LSM Ratio (HI/Healthy) is contained within the interval \[0.50, 2.00\].|LSM Ratio|2.231|||||TWO_SIDED|90.0|0.844|5.896||||||The analysis was performed using an ANCOVA model. Parameters were log-transformed (using the natural logarithm) prior to analysis. Study population (i.e., HI or Healthy) was included as a fixed effect with continuous covariates age, BMI and a categorical covariate, gender. Gender was included from Part 2 analysis.||5.896|0.844|
72584204|NCT04390113|144699512|SUPERIORITY||Hazard Ratio (HR)|0.92||||0.6253|TWO_SIDED|95.0|0.55|1.55|||Log Rank|||||1.55|0.55|0.6253
72584205|NCT01611883|144699519|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Ezetimibe treatment group will be considered non-inferior to the placebo control group if the upper bound of the two-sided 95% confidence interval (CI) of the between-treatment difference (ezetimibe minus placebo) in means for change in HbA1c from baseline to the end of treatment does not exceed 0.5%.|Difference in Least-squares Means|0.08|||||TWO_SIDED|95.0|-0.07|0.23|||Longitudinal analysis of covariance|"Treatment group, HbA1c level, insulin use, time, and time × treatment group interaction as factors, and baseline as covariate"|ezetimibe minus placebo|||0.23|-0.07|
72584206|NCT01611883|144699520|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least-squares Means|0.0|||||TWO_SIDED|95.0|-0.47|0.47|||Longitudinal analysis of covariance||ezetimibe minus placebo|||0.47|-0.47|
72584207|NCT01611883|144699521|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least-squares Means|-4.8|||||TWO_SIDED|95.0|-12.1|2.5|||Longitudinal Analysis of Covariance||ezetimibe minus placebo|||2.5|-12.1|
72584208|NCT01611883|144699522|SUPERIORITY_OR_OTHER_LEGACY|||||||0.779|||||||Fisher Exact|||Comparison of percentage difference between ezetimibe and placebo||||0.779
72584209|NCT01611883|144699523|SUPERIORITY_OR_OTHER_LEGACY|||||||0.365|||||||Fisher Exact|||Comparison of percentage difference between ezetimibe and placebo||||0.365
72584210|NCT01611883|144699524|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least-squares Means|-21.05|||<|0.001|TWO_SIDED|95.0|-25.06|-17.03|||Longitudinal analysis of covariance|"Treatment group, HbA1c level, insulin use, time, and time × treatment group interaction as factors, and baseline as covariate"|ezetimibe minus placebo|||-17.03|-25.06|<0.001
72584211|NCT01611883|144699525|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least-squares Means|-13.54|||<|0.001|TWO_SIDED|95.0|-16.66|-10.42|||Longitudinal analysis of covariance|"Treatment group, HbA1c level, insulin use, time, and time × treatment group interaction as factors, and baseline as covariate"|ezetimibe minus placebo|||-10.42|-16.66|<0.001
72584212|NCT01611883|144699526|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least-squares Means|-11.36||||0.025|TWO_SIDED|95.0|-21.27|-1.44|||Longitudinal Analysis of Covariance|"Treatment group, HbA1c level, insulin use, time, and time × treatment group interaction as factors, and baseline as covariate"|ezetimibe minus placebo|||-1.44|-21.27|0.025
72584213|NCT01611883|144699527|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least-squares Means|2.45||||0.246|TWO_SIDED|95.0|-1.71|6.61|||Longitudinal Analysis of Covariance|"Treatment group, HbA1c level, insulin use, time, and time × treatment group interaction as factors, and baseline as covariate"|ezetimibe minus placebo|||6.61|-1.71|0.246
72584214|NCT01611883|144699528|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least-squares Means|-19.07|||<|0.001|TWO_SIDED|95.0|-22.71|-15.43|||Longitudinal Analysis of Covariance|"Treatment group, HbA1c level, insulin use, time, and time × treatment group interaction as factors, and baseline as covariate"|ezetimibe minus placebo|||-15.43|-22.71|<0.001
72584215|NCT00030901|144699529|SUPERIORITY_OR_OTHER|||||||0.73||95.0||||P-value is adjusted for stratification factors age older than 60, African American, baseline PSA, and vitamin E supplementation.|Regression, Logistic|||With target sample size of 466 randomized patients (233 per arm), there is a 90% of power to detect a one-third reduction in the three-year incidence rate of prostate cancer. The alpha level is set at 0.025, one-sided.||||0.73
72584216|NCT01205776|144699536|NON_INFERIORITY|p-value and 95% CI of the Difference derived from the Com-Nougue Approach of non-inferiority for two Kaplan-Meier Failure rates with a non-inferiority margin of 2% at the 0.05 level of significance.|Hazard Ratio (HR)|-3.1|||<|0.0001|TWO_SIDED|||||p-value and 95% CI of the Difference derived from the Com-Nougue Approach of non-inferiority for two Kaplan-Meier Failure rates with a non-inferiority margin of 2% at the 0.05 level of significance.|Com-Nougue|||||||<0.0001
72413242|NCT01156701|144335145|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.01|||||TWO_SIDED|95.0|1.0|1.02|||||Risk in cohort 1 minus risk in cohort 2|||1.02|1.00|
72413243|NCT01156701|144335145|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.0|||||TWO_SIDED|95.0|1.0|1.0|||||Protective effect of zanamivir on susceptible risk|||1.00|1.00|
72413244|NCT01156701|144335146|SUPERIORITY_OR_OTHER||Risk Difference (RD)|1.28|||||TWO_SIDED|95.0|-0.83|3.4|||||Direct effect of Zanamivir prophylaxis on bronchitis risk|||3.40|-0.83|
72413245|NCT01156701|144335146|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.24|||||TWO_SIDED|95.0|-0.98|0.47|||||Total effect of zanamivir prophylaxis|||0.47|-0.98|
72413246|NCT01156701|144335146|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.09|||||TWO_SIDED|95.0|-0.85|0.67|||||Direct effect of zanamivir prophylaxis when index is treated|||0.67|-0.85|
72551938|NCT00358449|144634221|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.7||||0.352|TWO_SIDED|95.0|-24.41|11.01|||van Elteren test||P-value, 95% CI, and Estimated value are presented for change from baseline values at Week 12|||11.01|-24.41|0.352
72551939|NCT00358449|144634221|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.25||||0.525|TWO_SIDED|95.0|-29.69|11.2|||van Elteren test||P-value, 95% CI, and Estimated value are presented for change from baseline values at Week 24|||11.20|-29.69|0.525
72551940|NCT00358449|144634221|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.79||||0.071|TWO_SIDED|95.0|-35.21|-0.38|||Van Elteren test||P-value, 95% CI, and Estimated value are presented for change from baseline at week 24|||-0.38|-35.21|0.071
72551941|NCT02589808|144634229|OTHER|||||||0.0005|||||||Kappa|||||||0.0005
72551942|NCT02163837|144634234|SUPERIORITY|the study was exploratory, the number of patients included was not calculated|||||<|0.05|||||||McNemar|||Mc Nemar symetry test for repeated measures and paired t-tests as appropriated||||<0.05
72551943|NCT01171690|144634240|SUPERIORITY_OR_OTHER|||||||0.01|TWO_SIDED||||||Matched pairs t test|||Matched pairs||||0.01
72551944|NCT01643707|144634246|SUPERIORITY|A chi-square test was performed to determine a difference between Phase 1 and Phase 2.|||||<|1e-05|||||||Chi-squared|||||||<0.00001
72551945|NCT01643707|144634247|EQUIVALENCE|Chi-Square test used to show any difference between Phase 1 and Phase 2|||||<|0.0001|||||||Chi-squared|||||||<0.0001
72551946|NCT01643707|144634248|EQUIVALENCE|Chi-Square test used to show any difference between Phase 1 and Phase 2|||||<|0.0001||||||This endpoint was covered in primary objective 2, so this analysis is the same as previously reported.|Chi-squared||||See Primary Objectives for additional details.|||<0.0001
72413247|NCT01156701|144335146|SUPERIORITY_OR_OTHER||Risk Difference (RD)|1.53|||||TWO_SIDED|95.0|-0.7|3.76|||||Risk in cohort 1 minus risk in cohort 2|||3.76|-0.70|
72551947|NCT01391793|144634253|SUPERIORITY|||||||0.16|||||||Regression, Logistic|The p-value is adjusted for the stratification variable, duration of fever, and for age at baseline (\<24 months, \>=24 months).||Null hypothesis: There is no difference between the two treatment arms regarding the proportion of children with renal scarring at the outcome DMSA renal scan.||||0.16
72551948|NCT01391793|144634254|SUPERIORITY|||||||0.25|||||||Test of equality - 2 Poisson parameters|The method used is a conditional test.||Null hypothesis: There is no difference between the two treatment arms regarding the proportion of children with severe renal scarring at the outcome DMSA renal scan.||||0.25
72413248|NCT01156701|144335146|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.16|||||TWO_SIDED|95.0|-0.44|0.12|||||Protective effect of zanamivir on susceptible risk|||0.12|-0.44|
72551949|NCT01391793|144634255|SUPERIORITY|||||||0.07|||||||Generalized estimating equations|The p-value is adjusted for the stratification variable, duration of fever, and for age at baseline (\<24 months, \>=24 months).||Null hypothesis: There is no difference between the two treatment arms regarding the mean proportion of children with renal scarring at the outcome DMSA scan taken across the 3 radiologists.||||0.07
72551950|NCT02087904|144634280|SUPERIORITY||LS Mean Difference|-0.3||||0.834|TWO_SIDED|95.0|-3.13|2.53||P-value for test of difference between ABT-981 25 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and Kellgren-Lawrence (K-L) grade as the main factors and baseline as a covariate.|ANCOVA|||||2.53|-3.13|0.834
72551951|NCT02087904|144634280|SUPERIORITY||LS Mean Difference|-2.9||||0.05|TWO_SIDED|95.0|-5.73|0.01||P-value for test of difference between ABT-981 100 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||||0.01|-5.73|0.05
72551952|NCT02087904|144634280|SUPERIORITY||LS Mean Difference|-1.2||||0.415|TWO_SIDED|95.0|-4.0|1.66||P-value for test of difference between ABT-981 200 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||||1.66|-4.00|0.415
72551953|NCT02087904|144634281|SUPERIORITY||LS Mean Difference|0.06||||0.145|TWO_SIDED|95.0|-0.021|0.141||P-value for test of difference between ABT-981 25 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||||0.141|-0.021|0.145
72551954|NCT02087904|144634281|SUPERIORITY||LS Mean Difference|-0.03||||0.52|TWO_SIDED|95.0|-0.11|0.056||P-value for test of difference between ABT-981 100 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||||0.056|-0.11|0.52
72551955|NCT02087904|144634281|SUPERIORITY||LS Mean Difference|0.06||||0.159|TWO_SIDED|95.0|-0.023|0.139||P-value for test of difference between ABT-981 200 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||||0.139|-0.023|0.159
72413249|NCT01156701|144335146|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.01|||||TWO_SIDED|95.0|0.99|1.03|||||Direct effect of Zanamivir prophylaxis on bronchitis risk|||1.03|0.99|
72413250|NCT01156701|144335146|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.0|||||TWO_SIDED|95.0|0.99|1.0|||||Total effect of zanamivir prophylaxis|||1.00|0.99|
72551956|NCT02087904|144634282|SUPERIORITY||LS Mean Difference|0.22||||0.897|TWO_SIDED|95.0|-3.193|3.642||P-value for test of difference between ABT-981 25 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||||3.642|-3.193|0.897
72551957|NCT02087904|144634282|SUPERIORITY||LS Mean Difference|-1.07||||0.542|TWO_SIDED|95.0|-4.515|2.377||P-value for test of difference between ABT-981 100 dose group and Placebo at each post-baseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||||2.377|-4.515|0.542
72551958|NCT02087904|144634282|SUPERIORITY||LS Mean Difference|-1.52||||0.385|TWO_SIDED|95.0|-4.95|1.916||P-value for test of difference between ABT-981 200 dose group and Placebo at each post-baseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||||1.916|-4.95|0.385
72584217|NCT01205776|144699548|NON_INFERIORITY|p-value and 95% CI of the Difference derived from the Com-Nougue Approach of non-inferiority for two Kaplan-Meier Failure rates with a non-inferiority margin of 8.4% at the 0.05 level of significance.|Hazard Ratio (HR)|4.0||||0.011|TWO_SIDED|||||p-value and 95% CI of the Difference derived from the Com-Nougue Approach of non-inferiority for two Kaplan-Meier Failure rates with a non-inferiority margin of 8.4% at the 0.05 level of significance.|Com-Nougue Approach|||||||0.011
72584218|NCT03817190|144699631|SUPERIORITY||Proportion of participants|-0.2277||||0.688|TWO_SIDED|95.0|-1.0415|0.586|||GLMM|||||0.5860|-1.0415|0.6880
72584219|NCT03817190|144699632|SUPERIORITY||Proportion of participants|-0.276||||0.4321|TWO_SIDED|95.0|-0.9185|0.3665|||GLMM|||||0.3665|-0.9185|0.4321
72584220|NCT01622673|144699644|NON_INFERIORITY_OR_EQUIVALENCE|The hypothesis will be supported if the lower limit of the 90% confidence interval (CI) falls above 0.4 for the geometric least squares mean ratio for TUMS® + raltegravir versus raltegravir alone|Geometric Least Squares Mean Ratio|0.678|||||TWO_SIDED|90.0|0.531|0.866|||Mixed Models Analysis|Analysis incorporated fixed effect for treatment and treatment period and random effect for participant|The parameter estimated, geometric least squares mean ratio, is geometric least squares mean C12hrs for TUMS® + raltegravir / geometric least squares mean C12hrs for raltegravir alone|||0.866|0.531|
72584221|NCT01622673|144699644|NON_INFERIORITY_OR_EQUIVALENCE|The hypothesis will be supported if the lower limit of the 90% CI falls above 0.4 for the geometric least squares mean ratio for MINTOX® + raltegravir versus raltegravir alone|Geometric Least Squares Mean Ratio|0.373|||||TWO_SIDED|90.0|0.293|0.475|||Mixed Models Analysis|Analysis incorporated fixed effect for treatment and treatment period and random effect for participant|The parameter estimated, geometric least squares mean ratio, is the geometric least squares mean C12hrs for MINTOX® + raltegravir / geometric least squares mean C12hrs for raltegravir alone|||0.475|0.293|
72584222|NCT01622673|144699645|NON_INFERIORITY_OR_EQUIVALENCE|The hypothesis will be supported if the lower limit of the 90% confidence interval (CI) falls above 0.4 for the geometric least squares mean ratio for MINTOX® before raltegravir versus raltegravir alone|Geometric Least Squares Mean Ratio|0.437|||||TWO_SIDED|90.0|0.344|0.554|||Mixed Models Analysis|Analysis incorporated fixed effect for treatment and random effect for participant|The parameter estimated, geometric least squares mean ratio, is geometric least squares mean C12hrs for MINTOX® before raltegravir / geometric least squares mean C12hrs for raltegravir alone|||0.554|0.344|
72413251|NCT01156701|144335146|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.0|||||TWO_SIDED|95.0|0.99|1.01|||||Direct effect of zanamivir prophylaxis when index is treated|||1.01|0.99|
72413252|NCT01156701|144335146|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.02|||||TWO_SIDED|95.0|0.99|1.04|||||Risk in cohort 1 minus risk in cohort 2|||1.04|0.99|
72584223|NCT01622673|144699645|NON_INFERIORITY_OR_EQUIVALENCE|The hypothesis will be supported if the lower limit of the 90% confidence interval (CI) falls above 0.4 for the geometric least squares mean ratio for MINTOX® after raltegravir versus raltegravir alone|Geometric Least Squares Mean Ratio|0.433|||||TWO_SIDED|90.0|0.341|0.55|||Mixed Models Analysis|Analysis incorporated fixed effect for treatment and random effect for participant|The parameter estimated, geometric least squares mean ratio, is geometric least squares mean C12hrs for MINTOX® after raltegravir / geometric least squares mean C12hrs for raltegravir alone|||0.550|0.341|
72584224|NCT01622673|144699646|NON_INFERIORITY_OR_EQUIVALENCE|The hypothesis will be supported if the lower limit of the 90% confidence interval (CI) falls above 0.4 for the geometric least squares mean ratio for TUMS® + raltegravir versus raltegravir alone|Geometric Least Squares Mean Ratio|0.445|||||TWO_SIDED|90.0|0.35|0.565|||Mixed Models Analysis|Analysis incorporated fixed effect for treatment and treatment period and random effect for participant|The parameter estimated, geometric least squares mean ratio, is geometric least squares mean AUC0-12hrs for TUMS® + raltegravir / geometric least squares mean AUC0-12hrs for raltegravir alone|||0.565|0.350|
72584225|NCT01622673|144699646|NON_INFERIORITY_OR_EQUIVALENCE|The hypothesis will be supported if the lower limit of the 90% confidence interval (CI) falls above 0.4 for the geometric least squares mean ratio for MINTOX® + raltegravir versus raltegravir alone|Geometric Least Squares Mean Ratio|0.51|||||TWO_SIDED|90.0|0.402|0.646|||Mixed Models Analysis|Analysis incorporated fixed effect for treatment and treatment period and random effect for participant|The parameter estimated, geometric least squares mean ratio, is geometric least squares mean AUC0-12hrs for MINTOX® + raltegravir / geometric least squares mean AUC0-12hrs for raltegravir alone|||0.646|0.402|
72584226|NCT01622673|144699647|NON_INFERIORITY_OR_EQUIVALENCE|The hypothesis will be supported if the lower limit of the 90% confidence interval (CI) falls above 0.4 for the geometric least squares mean ratio for MINTOX® before raltegravir versus raltegravir alone|Geometric Least Squares Mean Ratio|0.485|||||TWO_SIDED|90.0|0.351|0.669|||Mixed Models Analysis|Analysis incorporated fixed effect for treatment and random effect for participant|The parameter estimated, geometric least squares mean ratio, is geometric least squares mean AUC0-12hrs for MINTOX® before raltegravir / geometric least squares mean AUC0-12hrs for raltegravir alone|||0.669|0.351|
72584227|NCT01622673|144699647|NON_INFERIORITY_OR_EQUIVALENCE|The hypothesis will be supported if the lower limit of the 90% confidence interval (CI) falls above 0.4 for the geometric least squares mean ratio for MINTOX® after raltegravir versus raltegravir alone|Geometric Least Squares Mean Ratio|0.696|||||TWO_SIDED|90.0|0.504|0.96|||Mixed Models Analysis|Analysis incorporated fixed effect for treatment and random effect for participant|The parameter estimated, geometric least squares mean ratio, is geometric least squares mean AUC0-12hrs for MINTOX® after raltegravir / geometric least squares mean AUC0-12hrs for raltegravir alone|||0.960|0.504|
72584228|NCT01622673|144699648|NON_INFERIORITY_OR_EQUIVALENCE|The hypothesis will be supported if the lower limit of the 90% confidence interval (CI) falls above 0.4 for the geometric least squares mean ratio for TUMS® + raltegravir versus raltegravir alone|Geometric Least Squares Mean Ratio|0.476|||||TWO_SIDED|90.0|0.362|0.627|||Mixed Models Analysis|Analysis incorporated fixed effect for treatment and treatment period and random effect for participant|The parameter estimated, geometric least squares mean ratio, is geometric least squares mean Cmax for TUMS® + raltegravir / geometric least squares mean Cmax for raltegravir alone|||0.627|0.362|
72584229|NCT01622673|144699648|NON_INFERIORITY_OR_EQUIVALENCE|The hypothesis will be supported if the lower limit of the 90% CI falls above 0.4 for the geometric least squares mean ratio for MINTOX® + raltegravir versus raltegravir alone|Geometric Least Squares Mean Ratio|0.555|||||TWO_SIDED|95.0|0.423|0.729|||Mixed Models Analysis|Analysis incorporated fixed effect for treatment and treatment period and random effect for participant|The parameter estimated, geometric least squares mean ratio, is the geometric least squares mean Cmax for MINTOX® + raltegravir / geometric least squares mean Cmax for raltegravir alone|||0.729|0.423|
72584230|NCT01622673|144699649|NON_INFERIORITY_OR_EQUIVALENCE|The hypothesis will be supported if the lower limit of the 90% confidence interval (CI) falls above 0.4 for the geometric least squares mean ratio for MINTOX® before raltegravir versus raltegravir alone|Geometric Least Squares Mean Ratio|0.485|||||TWO_SIDED|90.0|0.332|0.709|||Mixed Models Analysis|Analysis incorporated fixed effect for treatment and random effect for participant|The parameter estimated, geometric least squares mean ratio, is geometric least squares mean Cmax for MINTOX® before raltegravir / geometric least squares mean Cmax for raltegravir alone|||0.709|0.332|
72584231|NCT01622673|144699649|NON_INFERIORITY_OR_EQUIVALENCE|The hypothesis will be supported if the lower limit of the 90% confidence interval (CI) falls above 0.4 for the geometric least squares mean ratio for MINTOX® after raltegravir versus raltegravir alone|Geometric Least Squares Mean Ratio|0.775|||||TWO_SIDED|90.0|0.53|1.132|||Mixed Models Analysis|Analysis incorporated fixed effect for treatment and random effect for participant|The parameter estimated, geometric least squares mean ratio, is geometric least squares mean Cmax for MINTOX® after raltegravir / geometric least squares mean Cmax for raltegravir alone|||1.132|0.530|
72584232|NCT05142722|144699676|SUPERIORITY||Least Squares (LS) Means|-32.65|STANDARD_ERROR_OF_MEAN|1.602|<|0.0001|TWO_SIDED|95.0|-35.79|-29.5|||ANCOVA|||||-29.50|-35.79|<.0001
72584233|NCT05142722|144699677|SUPERIORITY||Least Squares (LS) Means|-33.78|STANDARD_ERROR_OF_MEAN|1.678|<|0.0001|TWO_SIDED|95.0|-37.07|-30.49|||ANCOVA|||||-30.49|-37.07|<.0001
72584234|NCT05142722|144699678|SUPERIORITY||Least Squares (LS) Means|-23.98|STANDARD_ERROR_OF_MEAN|1.979|<|0.0001|TWO_SIDED|95.0|-27.87|-20.09||The hierarchical testing procedure would only be conducted if the previous secondary efficacy endpoint reached a statistically significant treatment effect at p-value\<0.05|ANCOVA|||||-20.09|-27.87|<.0001
72584235|NCT05142722|144699679|SUPERIORITY||Least Squares (LS) Means|-18.92|STANDARD_ERROR_OF_MEAN|0.936|<|0.0001|TWO_SIDED|95.0|-20.76|-17.09||The hierarchical testing procedure would only be conducted if the previous secondary efficacy endpoint reached a statistically significant treatment effect at p-value\<0.05|ANCOVA|||||-17.09|-20.76|<.0001
72413253|NCT01156701|144335146|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.0|||||TWO_SIDED|95.0|1.0|1.0|||||Protective effect of zanamivir on susceptible risk|||1.00|1.00|
72413254|NCT01156701|144335147|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.14|||||TWO_SIDED|95.0|-3.08|2.79|||||Direct effect of Zanamivir prophylaxis on risk of any respiratory diagnosis|||2.79|-3.08|
72413255|NCT01156701|144335147|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-1.07|||||TWO_SIDED|95.0|-2.39|0.25|||||Total effect of zanamivir prophylaxis|||0.25|-2.39|
72584236|NCT05142722|144699680|SUPERIORITY||Least Squares (LS) Means|-18.31|STANDARD_ERROR_OF_MEAN|1.057|<|0.0001|TWO_SIDED|95.0|-20.38|-16.23||The hierarchical testing procedure would only be conducted if the previous secondary efficacy endpoint reached a statistically significant treatment effect at p-value\<0.05|ANCOVA|||||-16.23|-20.38|<.0001
72584237|NCT05142722|144699681|SUPERIORITY||Least Squares (LS) Means|-13.8|STANDARD_ERROR_OF_MEAN|1.219|<|0.0001|TWO_SIDED|95.0|-16.2|-11.41||The hierarchical testing procedure would only be conducted if the previous secondary efficacy endpoint reached a statistically significant treatment effect at p-value\<0.05|ANCOVA|||||-11.41|-16.20|<.0001
72584238|NCT05142722|144699682|SUPERIORITY||Least Squares (LS) Means|-29.44|STANDARD_ERROR_OF_MEAN|1.251|<|0.0001|TWO_SIDED|95.0|-31.89|-26.99||The hierarchical testing procedure would only be conducted if the previous secondary efficacy endpoint reached a statistically significant treatment effect at p-value\<0.05|ANCOVA|||||-26.99|-31.89|<.0001
72584239|NCT05142722|144699683|SUPERIORITY||Least Squares (LS) Means|-28.32|STANDARD_ERROR_OF_MEAN|1.339|<|0.0001|TWO_SIDED|95.0|-30.94|-25.69||The hierarchical testing procedure would only be conducted if the previous secondary efficacy endpoint reached a statistically significant treatment effect at p-value\<0.05|ANCOVA|||||-25.69|-30.94|<.0001
72584240|NCT05142722|144699684|SUPERIORITY||Least Squares (LS) Means|-23.02|STANDARD_ERROR_OF_MEAN|1.564|<|0.0001|TWO_SIDED|95.0|-26.09|-19.95||The hierarchical testing procedure would only be conducted if the previous secondary efficacy endpoint reached a statistically significant treatment effect at p-value\<0.05|ANCOVA|||||-19.95|-26.09|<.0001
72584241|NCT05142722|144699685|SUPERIORITY||Least Squares (LS) Means|136.26|STANDARD_ERROR_OF_MEAN|1.939|<|0.0001|TWO_SIDED|95.0|132.46|140.07||The hierarchical testing procedure would only be conducted if the previous secondary efficacy endpoint reached a statistically significant treatment effect at p-value\<0.05|ANCOVA|||||140.07|132.46|<.0001
72584242|NCT05142722|144699686|SUPERIORITY||Least Squares (LS) Means|134.43|STANDARD_ERROR_OF_MEAN|2.343|<|0.0001|TWO_SIDED|95.0|129.84|139.03||The hierarchical testing procedure would only be conducted if the previous secondary efficacy endpoint reached a statistically significant treatment effect at p-value\<0.05|ANCOVA|||||139.03|129.84|<.0001
72584243|NCT05142722|144699687|SUPERIORITY||Least Squares (LS) Means|122.04|STANDARD_ERROR_OF_MEAN|2.299|<|0.0001|TWO_SIDED|95.0|117.53|126.55||The hierarchical testing procedure would only be conducted if the previous secondary efficacy endpoint reached a statistically significant treatment effect at p-value\<0.05|ANCOVA|||||126.55|117.53|<.0001
72584244|NCT05142722|144699688|SUPERIORITY||Least Squares (LS) Means|-14.12|STANDARD_ERROR_OF_MEAN|20.183||0.4841|TWO_SIDED|95.0|-53.68|25.44||The hierarchical testing procedure would only be conducted if the previous secondary efficacy endpoint reached a statistically significant treatment effect at p-value\<0.05; therefore hierarchical testing was stopped for subsequent secondary endpoints|ANCOVA|||||25.44|-53.68|0.4841
72584245|NCT00437021|144699724|NON_INFERIORITY|The non-inferiority margin is 1. Non-inferiority of Group A is concluded if the upper limit of the 95% confidence interval for the mean difference in the log2 transformed peak titers between groups is less than 1.|Mean Difference (Final Values)|1.48|||||TWO_SIDED|95.0|0.97|1.99|||||Estimate and corresponding 95% confidence interval are calculated on the log2 scale.|Null hypothesis: The mean difference in log2 transformed titers between Group B and Group A \>= 1.||1.99|0.97|
72584246|NCT00437021|144699725|NON_INFERIORITY|The non-inferiority margin is 1. Non-inferiority of Group A is concluded if the upper limit of the 95% confidence interval for the mean difference in the log2 transformed peak titers between groups is less than 1.|Mean Difference (Final Values)|2.895|||||TWO_SIDED|95.0|2.22|3.69|||||Estimate and corresponding 95% confidence interval are calculated on the log2 scale.|Null hypothesis: The mean difference in log2 transformed titers between Group B and Group A \>= 1.||3.69|2.22|
72584247|NCT00437021|144699733|NON_INFERIORITY|The non-inferiority margin is 1. Non-inferiority of Group A is concluded if the upper limit of the 95% confidence interval for the mean difference in the log2 transformed peak titers between groups is less than 1.|Mean Difference (Final Values)|2.21|||||TWO_SIDED|95.0|1.65|2.76|||||Estimate and corresponding 95% confidence interval are calculated on the log2 scale.|Null hypothesis: The mean difference in log2 transformed titers between Group B and Group A \>= 1.||2.76|1.65|
72584248|NCT00437021|144699734|NON_INFERIORITY|The non-inferiority margin is 1. Non-inferiority of Group A is concluded if the upper limit of the 95% confidence interval for the mean difference in the log2 transformed peak titers between groups is less than 1.|Mean Difference (Final Values)|3.08|||||TWO_SIDED|95.0|2.57|3.59|||||Estimate and corresponding 95% confidence interval are calculated on the log2 scale.|Null hypothesis: The mean difference in log2 transformed titers between Group B and Group A \>= 1.||3.59|2.57|
72584249|NCT01467713|144699735|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.77||||0.286|TWO_SIDED|98.3|0.42|1.39|||Log Rank||Cox proportional hazards model with only treatment in the model.|||1.39|0.42|0.286
72584250|NCT01467713|144699735|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.78||||0.332|TWO_SIDED|98.3|0.43|1.43|||Log Rank||Cox proportional hazards model with only treatment in the model.|||1.43|0.43|0.332
72584251|NCT01467713|144699735|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.06||||0.808|TWO_SIDED|98.3|0.6|1.86|||Log Rank||Cox proportional hazards model with only treatment in the model.|||1.86|0.60|0.808
72584252|NCT01467713|144699735|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.88||||0.286|TWO_SIDED|98.3|0.48|1.61|||Log Rank||Cox proportional hazards model with treatment, pooled center, age, gender, and baseline MADRS score in the model.|||1.61|0.48|0.286
72584253|NCT01467713|144699735|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.79||||0.332|TWO_SIDED|98.3|0.42|1.49|||Log Rank||Cox proportional hazards model with treatment, pooled center, age, gender, and baseline MADRS score in the model.|||1.49|0.42|0.332
72584254|NCT01467713|144699735|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.08||||0.808|TWO_SIDED|98.3|0.6|1.95|||Log Rank||Cox proportional hazards model with treatment, pooled center, age, gender, and baseline MADRS score in the model.|||1.95|0.60|0.808
72413256|NCT01156701|144335147|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-1.08|||||TWO_SIDED|95.0|-2.51|0.35|||||Direct effect of zanamivir prophylaxis when index is treated|||0.35|-2.51|
72413257|NCT01156701|144335147|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.93|||||TWO_SIDED|95.0|-2.29|4.14|||||Risk in cohort 1 minus risk in cohort 2|||4.14|-2.29|
72413258|NCT01156701|144335147|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.01|||||TWO_SIDED|95.0|-0.58|0.59|||||Protective effect of zanamivir on susceptible risk|||0.59|-0.58|
72584255|NCT01100086|144699756|NON_INFERIORITY_OR_EQUIVALENCE|A mixed-model analysis of variance was used to compare (test vs reference) and the 90% confidence intervals were estimated for the ratios (test/reference)|Geometric Test/Ref Ratio x 100|102.0|||||TWO_SIDED|90.0|99.35|105.42|||ANOVA||Bioequivalence is established when 90% Confidence Interval falls within 80%-125%.|||105.42|99.35|
72584256|NCT01100086|144699757|NON_INFERIORITY_OR_EQUIVALENCE|A mixed-model analysis of variance was used to compare (test vs reference) and the 90% confidence intervals were estimated for the ratios (test/reference)|Geometric Test/Ref Ratio x 100|98.0|||||TWO_SIDED|90.0|94.94|101.19|||ANOVA||Bioequivalence is established when 90% Confidence Interval falls within 80%-125%.|||101.19|94.94|
72584257|NCT01100086|144699758|NON_INFERIORITY_OR_EQUIVALENCE|A mixed-model analysis of variance was used to compare (test vs reference) and the 90% confidence intervals were estimated for the ratios (test/reference)|Geometric Test/Ref Ratio x 100|98.3|||||TWO_SIDED|90.0|95.2|101.48|||||Bioequivalence is established when 90% Confidence Interval falls within 80%-125%.|||101.48|95.20|
72584258|NCT01100086|144699758|NON_INFERIORITY_OR_EQUIVALENCE|A mixed-model analysis of variance was used to compare (test vs reference) and the 90% confidence intervals were estimated for the ratios (test/reference).|Geometric Test/Ref Ratio x 100|98.3|||||TWO_SIDED|90.0|95.2|101.48|||ANOVA||Bioequivalence is established when 90% Confidence Interval falls within 80%-125%.|||101.48|95.20|
72584259|NCT03446027|144699762|OTHER|"Prespecified Tobit Regression mode: the model included the AWD baseline measurement, a treatment indicator and the type of centre (SET versus non-SET) as covariates. As the data collected for AWD showed a right-skewed distribution, a square root transformation was used to normalise the data and used for the regression Tobit model. This resulted in the unit of measure being units rather than meters."|square root transformation|0.835||||0.28|TWO_SIDED|95.0|-0.674|2.343|||Tobit Regression|||"Right censored Tobit regression model for AWD at 3 months for the ITT population.~Difference between arms (between baseline and 3 months) - the primary analysis estimates the difference in the AWD at 3 months between the two treatment groups control vs. device. Control group includes both BMT and BMT + SET and the treatment group includes NMES + BMT and NMES + BMT + SET Included participants with both baseline and 3 month treadmill data."||2.343|-0.674|0.28
72584260|NCT03446027|144699763|OTHER|"Right censored, Tobit Regression model to assess the effects of baseline characteristics for ICD at 3 months for the ITT Population. This resulted in the unit of measure being units and not meters.~Included participants with both baseline and 3 month treadmill data. Calculation between arms - estimates the difference in the ICD at 3 months between the two treatment groups.~Control group includes both BMT and BMT + SET and the treatment group includes NMES + BMT and NMES + BMT + SET"|square root transformation|0.972||||0.23|TWO_SIDED|95.0|-0.6|2.546|||Right censored, Tobit Regression|||||2.546|-0.600|0.23
72584261|NCT03446027|144699767|OTHER|"Linear Regression Model for Duplex ultrasonography (Volume flow - measured in one leg) at 3 months for the ITT population.~Difference (calculation) between the two groups and not per arm (control vs treatment). Unit of measure is Units due to the use of a linear regression model rather than cc/min."|Linear regression|0.483||||0.516|TWO_SIDED|95.0|-0.984|1.95|||Regression, Linear|||||1.950|-0.984|0.516
72584262|NCT05344560|144699869|NON_INFERIORITY|A non-inferiority margin of -5 points was used.|Mean Difference (Final Values)|-2.92|STANDARD_ERROR_OF_MEAN|2.018|||TWO_SIDED|95.0|-6.92|1.07|||Generalized Linear Mixed Model|Kenward and Roger Method was used for the denominator degrees of freedom.|Mean difference was calculated as Test \[senofilcon A (C3) HEV chromophore\] minus Control \[senofilcon A (C3)\]|||1.07|-6.92|
72584263|NCT00360282|144699870|SUPERIORITY_OR_OTHER|||||||0.007|TWO_SIDED||||||Sign test|||||||0.007
72584264|NCT00360282|144699871|SUPERIORITY_OR_OTHER|||||||0.549|TWO_SIDED||||||Sign test|||||||.549
72584265|NCT00449865|144699885|SUPERIORITY_OR_OTHER|||||||0.45|TWO_SIDED||||||Global Statistical Test|The global statistical test yielded t = -0.75 (2-sided p-value = .45, df=1865.8).||||||0.45
72584266|NCT00444535|144699886|OTHER|Clopper-Pearson exact test (binomial)|Exact binomial procedure|69.2||||||95.0|54.9|81.3||||||||81.3|54.9|
72584267|NCT00558467|144699899|SUPERIORITY_OR_OTHER||Least Squares mean difference|0.01||||0.996|TWO_SIDED|95.0|-4.95|4.97|||ANCOVA|||||4.97|-4.95|0.996
72584268|NCT00558467|144699900|SUPERIORITY_OR_OTHER||Least square means difference|-3.94|||||TWO_SIDED|95.0|-5.81|-2.08|||Repeated Measures|||||-2.08|-5.81|
72413259|NCT01156701|144335147|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.0|||||TWO_SIDED|95.0|0.97|1.03|||||Direct effect of Zanamivir prophylaxis on risk of any respiratory diagnosis|||1.03|0.97|
72413260|NCT01156701|144335147|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.99|||||TWO_SIDED|95.0|0.98|1.0|||||Total effect of zanamivir prophylaxis|||1.00|0.98|
72413261|NCT01156701|144335147|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.99|||||TWO_SIDED|95.0|0.98|1.0|||||Direct effect of zanamivir prophylaxis when index is treated|||1.00|0.98|
72413262|NCT01156701|144335147|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.01|||||TWO_SIDED|95.0|0.98|1.04|||||Risk in cohort 1 minus risk in cohort 2|||1.04|0.98|
72413263|NCT01156701|144335147|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.0|||||TWO_SIDED|95.0|0.99|1.0|||||Protective effect of zanamivir on susceptible risk|||1.00|0.99|
72413264|NCT03819660|144335189|OTHER||percentage|38.5|||||TWO_SIDED|||||||||||||
72551959|NCT02087904|144634283|SUPERIORITY||LS Mean Difference|-0.08||||0.384|TWO_SIDED|95.0|-0.249|0.096||P-value for test of difference between ABT-981 25 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||||0.096|-0.249|0.384
72551960|NCT02087904|144634283|SUPERIORITY||LS Mean Difference|-0.15||||0.095|TWO_SIDED|95.0|-0.324|0.026||P-value for test of difference between ABT-981 100 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||||0.026|-0.324|0.095
72551961|NCT02087904|144634283|SUPERIORITY||LS Mean Difference|-0.14||||0.106|TWO_SIDED|95.0|-0.314|0.03||P-value for test of difference between ABT-981 200 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||||0.03|-0.314|0.106
72551962|NCT02087904|144634284|SUPERIORITY||LS Mean Difference|-1.1||||0.818|TWO_SIDED|95.0|-10.22|8.08||P-value for test of difference between ABT-981 25 mg dose group and placebo at each postbaseline time point is from an ANCOVA model with treatment, age, K-L grade as the main factors and baseline as a covariate.|ANCOVA|||||8.08|-10.22|0.818
72551963|NCT02087904|144634284|SUPERIORITY||LS Mean Difference|-7.6||||0.109|TWO_SIDED|95.0|-16.83|1.69||P-value for test of difference between ABT-981 100 mg dose group and placebo at each postbaseline time point is from an ANCOVA model with treatment, age, K-L grade as the main factors and baseline as a covariate.|ANCOVA|||||1.69|-16.83|0.109
72584269|NCT00558467|144699901|SUPERIORITY_OR_OTHER||Least square means difference|-5.3|||||TWO_SIDED|95.0|-7.21|-3.39|||Repeated measures|||||-3.39|-7.21|
72584270|NCT00558467|144699903|SUPERIORITY_OR_OTHER||Least square means difference|-5.97|||||TWO_SIDED|95.0|-7.88|-4.06|||Repeated measures|||||-4.06|-7.88|
72584271|NCT00558467|144699904|SUPERIORITY_OR_OTHER||Least Squares Mean differnce|-0.15||||0.978|TWO_SIDED|95.0|-11.05|10.75|||ANCOVA|||||10.75|-11.05|0.9780
72584272|NCT00558467|144699909|SUPERIORITY_OR_OTHER|||||||0.1052|||||||Cochran-Mantel-Haenszel|||||||0.1052
72584273|NCT00558467|144699910|SUPERIORITY_OR_OTHER|||||||0.2274|||||||Cochran-Mantel-Haenszel|||||||0.2274
72584274|NCT00558467|144699911|SUPERIORITY_OR_OTHER|||||||0.7691|||||||Cochran-Mantel-Haenszel|||||||0.7691
72584275|NCT00558467|144699912|SUPERIORITY_OR_OTHER|||||||0.0674|||||||Cochran-Mantel-Haenszel|||||||0.0674
72551964|NCT02087904|144634284|SUPERIORITY||LS Mean Difference|-3.4||||0.465|TWO_SIDED|95.0|-12.58|5.76||P-value for test of difference between ABT-981 200 mg dose group and placebo at each postbaseline time point is from an ANCOVA model with treatment, age, K-L grade as the main factors and baseline as a covariate.|ANCOVA|||||5.76|-12.58|0.465
72551965|NCT02087904|144634285|SUPERIORITY||LS Mean Difference|-2.1||||0.666|TWO_SIDED|95.0|-11.76|7.52||P-value for test of difference between ABT-981 25 mg dose group and placebo at each postbaseline time point is from an ANCOVA model with treatment, age, K-L grade as the main factors and baseline as a covariate.|ANCOVA|||||7.52|-11.76|0.666
72551966|NCT02087904|144634285|SUPERIORITY||LS Mean Difference|-9.2||||0.065|TWO_SIDED|95.0|-18.95|0.56||P-value for test of difference between ABT-981 100 mg dose group and placebo at each postbaseline time point is from an ANCOVA model with treatment, age, K-L grade as the main factors and baseline as a covariate.|ANCOVA|||||0.56|-18.95|0.065
72584276|NCT00558467|144699913|SUPERIORITY_OR_OTHER|||||||0.4944|||||||Cochran-Mantel-Haenszel|||||||0.4944
72584277|NCT00558467|144699914|SUPERIORITY_OR_OTHER|||||||0.162|||||||Cochran-Mantel-Haenszel|||||||0.162
72551967|NCT02087904|144634285|SUPERIORITY||LS Mean Difference|-7.2||||0.145|TWO_SIDED|95.0|-16.84|2.49||P-value for test of difference between ABT-981 200 mg dose group and placebo at each postbaseline time point is from an ANCOVA model with treatment, age, K-L grade as the main factors and baseline as a covariate.|ANCOVA|||||2.49|-16.84|0.145
72584278|NCT00558467|144699915|SUPERIORITY_OR_OTHER|||||||0.6375|||||||Cochran-Mantel-Haenszel|||||||0.6375
72584279|NCT00558467|144699916|SUPERIORITY_OR_OTHER|||||||0.6625|||||||Cochran-Mantel-Haenszel|||||||0.6625
72584280|NCT00558467|144699917|SUPERIORITY_OR_OTHER|||||||0.2664|||||||Cochran-Mantel-Haenszel|||||||0.2664
72584281|NCT00558467|144699918|SUPERIORITY_OR_OTHER|||||||0.7302|||||||Cochran-Mantel-Haenszel|||||||0.7302
72584282|NCT00558467|144699919|SUPERIORITY_OR_OTHER|||||||0.7723|||||||Cochran-Mantel-Haenszel|||||||0.7723
72584283|NCT00558467|144699920|SUPERIORITY_OR_OTHER|||||||0.4852|||||||Cochran-Mantel-Haenszel|||||||0.4852
72584284|NCT00558467|144699921|SUPERIORITY_OR_OTHER|||||||0.4607|||||||Cochran-Mantel-Haenszel|||||||0.4607
72584285|NCT00558467|144699922|SUPERIORITY_OR_OTHER|||||||0.7723|||||||Cochran-Mantel-Haenszel|||||||0.7723
72584286|NCT00558467|144699923|SUPERIORITY_OR_OTHER|||||||0.9389|||||||Cochran-Mantel-Haenszel|||||||0.9389
72584287|NCT02025725|144699931|SUPERIORITY|||||||0.881|||||||ANCOVA|||||||0.881
72584288|NCT02025725|144699932|SUPERIORITY||Mean Difference (Net)|-0.201||||0.036|TWO_SIDED||||||ANCOVA|||Change in mean daily GSA total score from Baseline to Week 1: metoclopramide nasal spray minus placebo.||||0.036
72584289|NCT02025725|144699932|SUPERIORITY||Mean Difference (Net)|-0.336||||0.025|TWO_SIDED||||||ANCOVA|||Change in mean daily GSA total score from Baseline to Week 2: metoclopramide nasal spray minus placebo||||0.025
72584290|NCT02025725|144699932|SUPERIORITY||Mean Difference (Net)|-0.347||||0.039|TWO_SIDED||||||ANCOVA|||Change in mean daily GSA total score from Baseline to Week 3: metoclopramide nasal spray minus placebo.||||0.039
72584291|NCT02025725|144699932|SUPERIORITY||Mean Difference (Net)|-0.364||||0.085|TWO_SIDED||||||ANCOVA|||Change in mean daily GSA total score from Baseline to Week 4: metoclopramide nasal spray minus placebo.||||0.085
72584292|NCT02565628|144699998|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-5.02|STANDARD_ERROR_OF_MEAN|10.49||0.6382|ONE_SIDED|90.0||8.97|||Mixed Models Analysis|||||8.97||0.6382
72584293|NCT04846569|144700029|SUPERIORITY||Mean Difference (Final Values)|0.004|||||TWO_SIDED|95.0|-0.38|0.39||||||||0.39|-0.38|
72584294|NCT04846569|144700030|SUPERIORITY||Mean Difference (Final Values)|-0.15|||||TWO_SIDED|95.0|-0.78|0.47||||||||0.47|-0.78|
72584295|NCT04846569|144700031|SUPERIORITY|||||||||||||||||All participants who we were able to obtain records for were virally suppressed thus an effect size was unable to be calculated.|All participants who we were able to obtain records for were virally suppressed thus an effect size was unable to be calculated as originally planned.|||
72551968|NCT02087904|144634286|SUPERIORITY||LS Mean Difference|-3.2||||0.558|TWO_SIDED|95.0|-14.03|7.59||P-value for test of difference between ABT-981 25 mg dose group and placebo at each postbaseline time point is from an ANCOVA model with treatment, age, K-L grade as the main factors and baseline as a covariate.|ANCOVA|||||7.59|-14.03|0.558
72584296|NCT04846569|144700032|SUPERIORITY||Median Difference (Final Values)|0.2|||||TWO_SIDED|95.0|-0.2|0.53||||||||0.53|-0.20|
72584297|NCT04846569|144700033|OTHER|Qualitative data analysis|||||||||||||||||Thematic qualitative data analysis was conducted to determine the count of participants reporting positively about the intervention|||
72584298|NCT02954601|144700046|OTHER|Values obtained using a Mixed Model Repeated Measures Analysis of Variance with an unstructured covariance matrix. Treatment, Period and Baseline value (for change and percent change) are factors in the model with repeated values for a subject.||||||0.1311|||||||Mixed Models Analysis|||||||0.1311
72584299|NCT02954601|144700049|OTHER|||||||0.3061|TWO_SIDED|95.0|||||Mixed Models Analysis|||Values obtained using a Mixed Model Repeated Measures Analysis of Variance with an unstructured covariance matrix. Treatment period and Baseline value (for change and percent change) are factors in the model with repeated values for subject.||||0.3061
72584300|NCT00333983|144700055|SUPERIORITY_OR_OTHER|||||||0.025||||||P value was set at .025 to adjust for 2 treatment comparisons and for interim monitoring for the treatment effect.|Mixed Models Analysis|||An analysis of all robot interventions compared with intensive conventional exercise for Fugl-Meyer change were completed using linear mixed models.||||.025
72584301|NCT04227197|144700056|SUPERIORITY|The p value compares the trend in the number of indicated or completed evaluations in the Intervention arm versus Control arm.||||||0.018|||||||Cochran-Armitage trend test|Two tailed; no continuity correction||||||0.018
72584302|NCT04227197|144700058|SUPERIORITY|The p value compares the change from baseline on quality of life measures between the Intervention group and Control group.||||||0.468|||||||ANOVA|||This is the p value for the PedsQL Psychosocial Health Score||||0.468
72584303|NCT04227197|144700058|SUPERIORITY|||||||0.802|||||||ANOVA|||This p value is for the PedsQL Physical Functioning Score||||0.802
72584304|NCT04227197|144700058|SUPERIORITY|||||||0.761|||||||ANOVA|||This is the p value for the PedsQL Total Scale Score||||0.761
72584305|NCT04227197|144700058|SUPERIORITY|||||||0.965|||||||ANOVA|||This is the p value for the PedsQL FIM Parental HRQL Summary Score||||0.965
72584306|NCT04227197|144700058|SUPERIORITY|||||||0.619|||||||ANOVA|||This is the p value for the PedsQL FIM Family Functioning Summary Score||||0.619
72584307|NCT04227197|144700058|SUPERIORITY|||||||0.469|||||||ANOVA|||This is the p value for the PedsQL FIM Total Scale Score||||0.469
72584308|NCT04227197|144700059|SUPERIORITY|The p value compares the change from baseline on quality of life measures between the Intervention group and Control group||||||0.068|||||||ANOVA|||This is for the change from baseline on PedsQL Psychosocial Health Score||||0.068
72584309|NCT04227197|144700059|SUPERIORITY|The p value compares the change from baseline on quality of life measures between the Intervention group and Control group||||||0.907|||||||ANOVA|||This is for the change from baseline for PedsQL Physical Functioning Score||||0.907
72584310|NCT04227197|144700059|SUPERIORITY|The p value compares the change from baseline on quality of life measures between the Intervention group and Control group||||||0.196|||||||ANOVA|||This is for the change from baseline for PedsQL Total Scale Score||||0.196
72584311|NCT04227197|144700059|SUPERIORITY|The p value compares the change from baseline on quality of life measures between the Intervention group and Control group||||||0.112|||||||ANOVA|||This is for the change from baseline for PedsQL FIM Parental HRQL Summary Score||||0.112
72584312|NCT04227197|144700059|SUPERIORITY|The p value compares the change from baseline on quality of life measures between the Intervention group and Control group||||||0.245|||||||ANOVA|||This is for change from baseline for PedsQL FIM Family Functioning Summary Score||||0.245
72584313|NCT04227197|144700059|SUPERIORITY|The p value compares the change from baseline on quality of life measures between the Intervention group and Control group||||||0.219|||||||ANOVA|||This is for change from baseline for PedsQL FIM Total Scale Score||||0.219
72584314|NCT02992236|144700063|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
72584315|NCT04556305|144700070|SUPERIORITY|||||||0.409|||||||Mixed Models Analysis|||Statistical Test 1: Main effect of Mind (MindMoves + Mind vs. Move + Usual Care) for change over time||||.409
72584316|NCT04556305|144700070|SUPERIORITY|||||||0.456|||||||Mixed Models Analysis|||Statistical Test 2: Main effect of Move (MindMoves + Move vs. Mind + Usual Care) for change over time||||.456
72551969|NCT02087904|144634286|SUPERIORITY||LS Mean Difference|-5.8||||0.295|TWO_SIDED|95.0|-16.77|5.11||P-value for test of difference between ABT-981 100 mg dose group and placebo at each postbaseline time point is from an ANCOVA model with treatment, age, K-L grade as the main factors and baseline as a covariate.|ANCOVA|||||5.11|-16.77|0.295
72551970|NCT02087904|144634286|SUPERIORITY||LS Mean Difference|-6.8||||0.218|TWO_SIDED|95.0|-17.63|4.04||P-value for test of difference between ABT-981 200 mg dose group and placebo at each postbaseline time point is from an ANCOVA model with treatment, age, K-L grade as the main factors and baseline as a covariate.|ANCOVA|||||4.04|-17.63|0.218
72584317|NCT04556305|144700070|SUPERIORITY|||||||0.692|||||||Mixed Models Analysis|||Statistical Test 3: Interaction effect of Mind x Move (MindMoves + Usual Care vs. Mind + Move) for change over time||||.692
72584318|NCT04556305|144700071|SUPERIORITY|||||||0.179|||||||Mixed Models Analysis|||Statistical Test 1: Main effect of Mind (MindMoves + Mind vs. Move + Usual Care) for change over time||||.179
72584319|NCT04556305|144700071|SUPERIORITY|||||||0.91|||||||Mixed Models Analysis|||Statistical Test 2: Main effect of Move (MindMoves + Move vs. Mind + Usual Care) for change over time||||.910
72551971|NCT02087904|144634287|SUPERIORITY||LS Mean Difference|-0.6||||0.664|TWO_SIDED|95.0|-3.58|2.28||P-value for test of difference between ABT-981 25 mg dose group and placebo at each postbaseline time point is from an ANCOVA model with treatment, age, K-L grade as the main factors and baseline as a covariate.|ANCOVA|||||2.28|-3.58|0.664
72584320|NCT04556305|144700071|SUPERIORITY|||||||0.159|||||||Mixed Models Analysis|||Statistical Test 3: Interaction effect of Mind x Move (MindMoves + Usual Care vs. Mind + Move) for change over time||||.159
72584321|NCT04556305|144700072|SUPERIORITY|||||||0.078|||||||Mixed Models Analysis|||Statistical Test 1: Main effect of Mind (MindMoves + Mind vs. Move + Usual Care) for change over time||||.078
72584322|NCT04556305|144700072|SUPERIORITY|||||||0.13|||||||Mixed Models Analysis|||Statistical Test 2: Main effect of Move (MindMoves + Move vs. Mind + Usual Care) for change over time||||.130
72584323|NCT04556305|144700072|SUPERIORITY|||||||0.43|||||||Mixed Models Analysis|||Statistical Test 3: Interaction effect of Mind x Move (MindMoves + Usual Care vs. Mind + Move) for change over time||||.430
72584324|NCT04556305|144700073|SUPERIORITY|||||||0.772|||||||Mixed Models Analysis|||Statistical Test 1: Main effect of Mind (MindMoves + Mind vs. Move + Usual Care) for change over time||||.772
72584325|NCT04556305|144700073|SUPERIORITY|||||||0.107|||||||Mixed Models Analysis|||Statistical Test 2: Main effect of Move (MindMoves + Move vs. Mind + Usual Care) for change over time||||.107
72584326|NCT04556305|144700073|SUPERIORITY|||||||0.915|||||||Mixed Models Analysis|||Statistical Test 3: Interaction effect of Mind x Move (MindMoves + Usual Care vs. Mind + Move) for change over time||||.915
72584327|NCT04556305|144700074|SUPERIORITY|||||||0.078|||||||Mixed Models Analysis|||Statistical Test 1: Main effect of Mind (MindMoves + Mind vs. Move + Usual Care) for change over time||||.078
72584328|NCT04556305|144700074|SUPERIORITY|||||||0.13|||||||Mixed Models Analysis|||Statistical Test 2: Main effect of Move (MindMoves + Move vs. Mind + Usual Care) for change over time||||.130
72584329|NCT04556305|144700074|SUPERIORITY|||||||0.43|||||||Mixed Models Analysis|||Statistical Test 3: Interaction effect of Mind x Move (MindMoves + Usual Care vs. Mind + Move) for change over time||||.430
72584330|NCT04556305|144700075|SUPERIORITY|||||||0.487|||||||Mixed Models Analysis|||Statistical Test 1: Main effect of Mind (MindMoves + Mind vs. Move + Usual Care) for change over time||||.487
72584331|NCT04556305|144700075|SUPERIORITY|||||||0.827|||||||Mixed Models Analysis|||Statistical Test 2: Main effect of Move (MindMoves + Move vs. Mind + Usual Care) for change over time||||.827
72584332|NCT04556305|144700075|SUPERIORITY|||||||0.908|||||||Mixed Models Analysis|||Statistical Test 3: Interaction effect of Mind x Move (MindMoves + Usual Care vs. Mind + Move) for change over time||||.908
72584333|NCT04556305|144700076|SUPERIORITY|||||||0.371|||||||Mixed Models Analysis|||Statistical Test 1: Main effect of Mind (MindMoves + Mind vs. Move + Usual Care) for change over time||||.371
72584334|NCT04556305|144700076|SUPERIORITY|||||||0.633|||||||Mixed Models Analysis|||Statistical Test 2: Main effect of Move (MindMoves + Move vs. Mind + Usual Care) for change over time||||.633
72584335|NCT04556305|144700076|SUPERIORITY|||||||0.23|||||||Mixed Models Analysis|||Statistical Test 3: Interaction effect of Mind x Move (MindMoves + Usual Care vs. Mind + Move) for change over time||||.230
72584336|NCT04556305|144700077|SUPERIORITY|||||||0.798|||||||Mixed Models Analysis|||Statistical Test 1: Main effect of Mind (MindMoves + Mind vs. Move + Usual Care) for change over time||||.798
72584337|NCT04556305|144700077|SUPERIORITY|||||||0.461|||||||Mixed Models Analysis|||Statistical Test 2: Main effect of Move (MindMoves + Move vs. Mind + Usual Care) for change over time||||.461
72584338|NCT04556305|144700077|SUPERIORITY|||||||0.419|||||||Mixed Models Analysis|||Statistical Test 3: Interaction effect of Mind x Move (MindMoves + Usual Care vs. Mind + Move) for change over time||||.419
72584339|NCT04556305|144700078|SUPERIORITY|||||||0.619|||||||Mixed Models Analysis|||Statistical Test 1: Main effect of Mind (MindMoves + Mind vs. Move + Usual Care) for change over time||||.619
72584340|NCT04556305|144700078|SUPERIORITY|||||||0.468|||||||Mixed Models Analysis|||Statistical Test 2: Main effect of Move (MindMoves + Move vs. Mind + Usual Care) for change over time||||.468
72584341|NCT04556305|144700078|SUPERIORITY|||||||0.387|||||||Mixed Models Analysis|||Statistical Test 3: Interaction effect of Mind x Move (MindMoves + Usual Care vs. Mind + Move) for change over time||||.387
72584342|NCT04556305|144700079|SUPERIORITY|||||||0.38|||||||Mixed Models Analysis|||Statistical Test 1: Main effect of Mind (MindMoves + Mind vs. Move + Usual Care) for change over time||||.380
72584343|NCT04556305|144700079|SUPERIORITY|||||||0.759|||||||Mixed Models Analysis|||Statistical Test 2: Main effect of Move (MindMoves + Move vs. Mind + Usual Care) for change over time||||.759
72584344|NCT04556305|144700079|SUPERIORITY|||||||0.219|||||||Mixed Models Analysis|||Statistical Test 3: Interaction effect of Mind x Move (MindMoves + Usual Care vs. Mind + Move) for change over time||||.219
72584345|NCT04556305|144700080|SUPERIORITY|||||||0.995|||||||Mixed Models Analysis|||Statistical Test 1: Main effect of Mind (MindMoves + Mind vs. Move + Usual Care) for change over time||||.995
72551972|NCT02087904|144634287|SUPERIORITY||LS Mean Difference|-2.7||||0.075|TWO_SIDED|95.0|-5.67|0.28||P-value for test of difference between ABT-981 100 mg dose group and placebo at each postbaseline time point is from an ANCOVA model with treatment, age, K-L grade as the main factors and baseline as a covariate.|ANCOVA|||||0.28|-5.67|0.075
72551973|NCT02087904|144634287|SUPERIORITY||LS Mean Difference|-2.4||||0.107|TWO_SIDED|95.0|-5.33|0.52||P-value for test of difference between ABT-981 200 mg dose group and placebo at each postbaseline time point is from an ANCOVA model with treatment, age, K-L grade as the main factors and baseline as a covariate.|ANCOVA|||||0.52|-5.33|0.107
72551974|NCT02087904|144634288|SUPERIORITY||LS Mean Difference|0.5||||0.5|TWO_SIDED|95.0|-4.26|2.08||P-value for test of difference between ABT-981 25 mg dose group and placebo at each postbaseline time point is from an ANCOVA model with treatment, age, K-L grade as the main factors and baseline as a covariate.|ANCOVA|||||2.08|-4.26|0.5
72551975|NCT02087904|144634288|SUPERIORITY||LS Mean Difference|-2.2||||0.186|TWO_SIDED|95.0|-5.39|1.05||P-value for test of difference between ABT-981 100 mg dose group and placebo at each postbaseline time point is from an ANCOVA model with treatment, age, K-L grade as the main factors and baseline as a covariate.|ANCOVA|||||1.05|-5.39|0.186
72551976|NCT02087904|144634288|SUPERIORITY||LS Mean Difference|-2.3||||0.157|TWO_SIDED|95.0|-5.46|0.88||P-value for test of difference between ABT-981 200 mg dose group and placebo at each postbaseline time point is from an ANCOVA model with treatment, age, K-L grade as the main factors and baseline as a covariate.|ANCOVA|||||0.88|-5.46|0.157
72551977|NCT02087904|144634289|SUPERIORITY||LS Mean Difference|0.2||||0.319|TWO_SIDED|95.0|-0.23|0.69||P-value for test of difference between ABT-981 25 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||||0.69|-0.23|0.319
72551978|NCT02087904|144634289|SUPERIORITY||LS Mean Difference|-0.1||||0.564|TWO_SIDED|95.0|-0.6|0.33||P-value for test of difference between ABT-981 100 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||||0.33|-0.6|0.564
72551979|NCT02087904|144634289|SUPERIORITY||LS Mean Difference|0.0||||0.966|TWO_SIDED|95.0|-0.45|0.47||P-value for test of difference between ABT-981 200 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||||0.47|-0.45|0.966
72551980|NCT02087904|144634290|SUPERIORITY||LS Mean Difference|0.1||||0.602|TWO_SIDED|95.0|-0.41|0.7||P-value for test of difference between ABT-981 25 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||||0.7|-0.41|0.602
72551981|NCT02087904|144634290|SUPERIORITY||LS Mean Difference|0.0||||0.953|TWO_SIDED|95.0|-0.55|0.58||P-value for test of difference between ABT-981 100 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||||0.58|-0.55|0.953
72551982|NCT02087904|144634290|SUPERIORITY||LS Mean Difference|-0.1||||0.83|TWO_SIDED|95.0|-0.61|0.49||P-value for test of difference between ABT-981 200 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||||0.49|-0.61|0.83
72551983|NCT02087904|144634291|SUPERIORITY||LS Mean Difference|0.7||||0.804|TWO_SIDED|95.0|-4.91|6.33||P-value for test of difference between ABT-981 25 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Intermittent pain||6.33|-4.91|0.804
72551984|NCT02087904|144634291|SUPERIORITY||LS Mean Difference|-1.1||||0.699|TWO_SIDED|95.0|-6.9|4.63||P-value for test of difference between ABT-981 100 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Intermittent pain||4.63|-6.9|0.699
72551985|NCT02087904|144634291|SUPERIORITY||LS Mean Difference|1.4||||0.636|TWO_SIDED|95.0|-4.37|7.14||P-value for test of difference between ABT-981 200 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Intermittent pain||7.14|-4.37|0.636
72551986|NCT02087904|144634291|SUPERIORITY||LS Mean Difference|0.9||||0.756|TWO_SIDED|95.0|-4.91|6.76||P-value for test of difference between ABT-981 25 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Constant pain||6.76|-4.91|0.756
72551987|NCT02087904|144634291|SUPERIORITY||LS Mean Difference|-5.6||||0.068|TWO_SIDED|95.0|-11.55|0.42||P-value for test of difference between ABT-981 100 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Constant pain||0.42|-11.55|0.068
72551988|NCT02087904|144634291|SUPERIORITY||LS Mean Difference|-1.4||||0.649|TWO_SIDED|95.0|-7.34|4.58||P-value for test of difference between ABT-981 200 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Constant pain||4.58|-7.34|0.649
72551989|NCT02087904|144634292|SUPERIORITY||LS Mean Difference|-1.0||||0.75|TWO_SIDED|95.0|-7.14|5.14||P-value for test of difference between ABT-981 25 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Intermittent pain||5.14|-7.14|0.75
72551990|NCT02087904|144634292|SUPERIORITY||LS Mean Difference|-2.6||||0.409|TWO_SIDED|95.0|-8.82|3.6||P-value for test of difference between ABT-981 100 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Intermittent pain||3.6|-8.82|0.409
72551991|NCT02087904|144634292|SUPERIORITY||LS Mean Difference|-3.0||||0.338|TWO_SIDED|95.0|-9.24|3.18||P-value for test of difference between ABT-981 200 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Intermittent pain||3.18|-9.24|0.338
72551992|NCT02087904|144634292|SUPERIORITY||LS Mean Difference|0.7||||0.817|TWO_SIDED|95.0|-5.59|7.08||P-value for test of difference between ABT-981 25 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Constant pain||7.08|-5.59|0.817
72551993|NCT02087904|144634292|SUPERIORITY||LS Mean Difference|-2.0||||0.544|TWO_SIDED|95.0|-8.37|4.43||P-value for test of difference between ABT-981 100 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Constant pain||4.43|-8.37|0.544
72551994|NCT02087904|144634292|SUPERIORITY||LS Mean Difference|-2.5||||0.437|TWO_SIDED|95.0|-8.91|3.86||P-value for test of difference between ABT-981 200 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Constant pain||3.86|-8.91|0.437
72584346|NCT04556305|144700080|SUPERIORITY|||||||0.946|||||||Mixed Models Analysis|||Statistical Test 2: Main effect of Move (MindMoves + Move vs. Mind + Usual Care) for change over time||||.946
72584347|NCT04556305|144700080|SUPERIORITY|||||||0.593|||||||Mixed Models Analysis|||Statistical Test 3: Interaction effect of Mind x Move (MindMoves + Usual Care vs. Mind + Move) for change over time||||.593
72584348|NCT04556305|144700081|SUPERIORITY|||||||0.092|||||||Mixed Models Analysis|||Statistical Test 1: Main effect of Mind (MindMoves + Mind vs. Move + Usual Care) for change over time||||.092
72551995|NCT02087904|144634293|SUPERIORITY||LS Mean Difference|-2.2||||0.545|TWO_SIDED|95.0|-9.31|4.92||P-value for test of difference between ABT-981 25 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Intermittent pain||4.92|-9.31|0.545
72584349|NCT04556305|144700081|SUPERIORITY|||||||0.245|||||||Mixed Models Analysis|||Statistical Test 2: Main effect of Move (MindMoves + Move vs. Mind + Usual Care) for change over time||||.245
72584350|NCT04556305|144700081|SUPERIORITY|||||||0.107|||||||Mixed Models Analysis|||Statistical Test 3: Interaction effect of Mind x Move (MindMoves + Usual Care vs. Mind + Move) for change over time||||.107
72551996|NCT02087904|144634293|SUPERIORITY||LS Mean Difference|-0.4||||0.909|TWO_SIDED|95.0|-7.65|6.81||P-value for test of difference between ABT-981 100 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Intermittent pain||6.81|-7.65|0.909
72551997|NCT02087904|144634293|SUPERIORITY||LS Mean Difference|-4.0||||0.278|TWO_SIDED|95.0|-11.23|3.25||P-value for test of difference between ABT-981 200 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Intermittent pain||3.25|-11.23|0.278
72551998|NCT02087904|144634293|SUPERIORITY||LS Mean Difference|-1.2||||0.732|TWO_SIDED|95.0|-8.42|5.92||P-value for test of difference between ABT-981 25 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Constant pain||5.92|-8.42|0.732
72584351|NCT04556305|144700082|SUPERIORITY|||||||0.244|||||||Mixed Models Analysis|||Statistical Test 1: Main effect of Mind (MindMoves + Mind vs. Move + Usual Care) for change over time||||.244
72584352|NCT04556305|144700082|SUPERIORITY|||||||0.085|||||||Mixed Models Analysis|||Statistical Test 2: Main effect of Move (MindMoves + Move vs. Mind + Usual Care) for change over time||||.085
72584353|NCT04556305|144700082|SUPERIORITY|||||||0.71|||||||Mixed Models Analysis|||Statistical Test 3: Interaction effect of Mind x Move (MindMoves + Usual Care vs. Mind + Move) for change over time||||.710
72584354|NCT04556305|144700083|SUPERIORITY|||||||0.491|||||||Mixed Models Analysis|||Statistical Test 1: Main effect of Mind (MindMoves + Mind vs. Move + Usual Care) for change over time||||.491
72584355|NCT04556305|144700083|SUPERIORITY|||||||0.444|||||||Mixed Models Analysis|||Statistical Test 2: Main effect of Move (MindMoves + Move vs. Mind + Usual Care) for change over time||||.444
72584356|NCT04556305|144700083|SUPERIORITY|||||||0.279|||||||Mixed Models Analysis|||Statistical Test 3: Interaction effect of Mind x Move (MindMoves + Usual Care vs. Mind + Move) for change over time||||.279
72551999|NCT02087904|144634293|SUPERIORITY||LS Mean Difference|-4.6||||0.216|TWO_SIDED|95.0|-11.86|2.69||P-value for test of difference between ABT-981 100 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Constant pain||2.69|-11.86|0.216
72413265|NCT01136291|144335197|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||t-test, 1 sided|||The homogeneity between the groups was compared by the Student's t test or the Mann-Whitney test for continuous variables and chi-square for categorical variables.A comparison between values before and after the study group session was performed by the Student's t test. The effect of the exercise was evaluated by repeated measures ANOVA, where the effect of time and group were evaluated on pressure, weight, Body Mass Index (BMI)and World Health Organization Quality of Life Questionnarie domains.||||<0.05
72552000|NCT02087904|144634293|SUPERIORITY||LS Mean Difference|-9.2||||0.014|TWO_SIDED|95.0|-16.42|-1.88||P-value for test of difference between ABT-981 200 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Constant pain||-1.88|-16.42|0.014
72552001|NCT02087904|144634294|SUPERIORITY||LS Mean Difference|0.0||||0.874|TWO_SIDED|95.0|-0.56|0.66||P-value for test of difference between ABT-981 25 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||7-day recall period||0.66|-0.56|0.874
72552002|NCT02087904|144634294|SUPERIORITY||LS Mean Difference|-0.2||||0.451|TWO_SIDED|95.0|-0.86|0.38||P-value for test of difference between ABT-981 100 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||7-day recall period||0.38|-0.86|0.451
72413266|NCT02308033|144335205|SUPERIORITY||||||<|0.001|||||||Chi-squared, Corrected|||||||<0.001
72552003|NCT02087904|144634294|SUPERIORITY||LS Mean Difference|0.3||||0.331|TWO_SIDED|95.0|-0.31|0.93||P-value for test of difference between ABT-981 200 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||7-day recall period||0.93|-0.31|0.331
72584357|NCT03808948|144700091|OTHER||Odds Ratio (OR)|0.62||||0.4842|TWO_SIDED|95.0|0.08|1.97|||Regression, Logistic|||Binary logistic regression with mGFR/eGFR ratio as independent variate, AKI as binary outcome||1.97|0.08|0.4842
72584358|NCT03982511|144700105|SUPERIORITY||Mean Difference (Net)|0.05|STANDARD_ERROR_OF_MEAN|0.14||0.73|TWO_SIDED|||||Given that this is a pilot RCT, primary aim is to estimate effect sizes for a more fully-powered RCT. P-values will be provided in addition to effect size.|ANOVA|Repeated measures|Effect size: 0.17|Difference on difference from T2 to T1 for BMI z-score||||.73
72584359|NCT03982511|144700105|SUPERIORITY||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|0.18||0.98|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|Repeated measures||Difference on difference for BMI z-score from T3 to T1|Effect size: -0.01|||.98
72584360|NCT03982511|144700105|SUPERIORITY||Mean Difference (Net)|1.93|STANDARD_ERROR_OF_MEAN|3.97||0.63|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|Repeated measures||Difference on difference for BMI percentile from T2 to T1|Effect size: 0.24|||0.63
72584361|NCT03982511|144700105|SUPERIORITY||Mean Difference (Net)|0.24|STANDARD_ERROR_OF_MEAN|4.51||0.96|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|Repeated measures||Difference on difference for BMI percentile from T3 to T1|Effect size: 0.03|||0.96
72584362|NCT03982511|144700106|SUPERIORITY||Mean Difference (Net)|0.2|STANDARD_ERROR_OF_MEAN|0.12||0.12|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|Repeated measures||Difference on difference for Emotion regulation subscale from T2 to T1|Effect size: 0.79|||0.12
72584363|NCT03982511|144700106|SUPERIORITY||Mean Difference (Net)|-0.01|STANDARD_ERROR_OF_MEAN|0.14||0.96|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|Repeated measures||Difference on difference for emotion regulation subscale from T3 to T1|Effect size: -0.02|||0.96
72584364|NCT03982511|144700107|SUPERIORITY||Mean Difference (Net)|-6.08|STANDARD_ERROR_OF_MEAN|5.42||0.28|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|Repeated measures||Difference on difference for child weekly screen time from T2 to T1|Effect size: -0.41|||0.28
72584365|NCT03982511|144700107|SUPERIORITY||Mean Difference (Net)|5.83|STANDARD_ERROR_OF_MEAN|7.17||0.43|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|Repeated measures||Difference on difference for child weekly screen time from T3 to T1|Effect size: 0.42|||0.43
72584366|NCT03982511|144700108|SUPERIORITY||Mean Difference (Net)|35.32|STANDARD_ERROR_OF_MEAN|23.86||0.16|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|Repeated measures||Difference on difference score for MVPA minutes from T2 to T1|Effect size: 0.85|||0.16
72584367|NCT03982511|144700108|SUPERIORITY|Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|Mean Difference (Net)|16.09|STANDARD_ERROR_OF_MEAN|30.32||0.61|TWO_SIDED||||||ANOVA|Repeated measures||Difference on difference score for MVPA minutes from T3 to T1|Effect size: 0.35|||0.61
72584368|NCT03982511|144700108|SUPERIORITY||Mean Difference (Net)|-64.4|STANDARD_ERROR_OF_MEAN|54.5||0.26|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|Repeated measures||Difference on difference score for sedentary minutes from T2 to T1|Effect size: -0.68|||0.26
72552004|NCT02087904|144634294|SUPERIORITY||LS Mean Difference|0.0||||0.932|TWO_SIDED|95.0|-0.73|0.67||P-value for test of difference between ABT-981 25 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Activity pain||0.67|-0.73|0.932
72552005|NCT02087904|144634294|SUPERIORITY||LS Mean Difference|-0.3||||0.344|TWO_SIDED|95.0|-1.07|0.37||P-value for test of difference between ABT-981 100 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Activity pain||0.37|-1.07|0.344
72584369|NCT03982511|144700108|SUPERIORITY||Mean Difference (Net)|66.25|STANDARD_ERROR_OF_MEAN|66.43||0.34|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|repeated measures||Difference on difference score for sedentary minutes from T3 to T1|effect size: 0.66|||0.34
72584370|NCT03982511|144700109|SUPERIORITY||Mean Difference (Net)|-0.64|STANDARD_ERROR_OF_MEAN|0.75||0.41|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|repeated measures||Difference on difference for parent-reported sleep time from T2 to T1|effect size: -0.41|||0.41
72584371|NCT03982511|144700109|SUPERIORITY||Mean Difference (Net)|1.39|STANDARD_ERROR_OF_MEAN|0.95||0.16|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|repeated measures||Difference on difference for parent-reported sleep time from T3 to T1|effect size: 0.76|||0.16
72552006|NCT02087904|144634294|SUPERIORITY||LS Mean Difference|0.3||||0.489|TWO_SIDED|95.0|-0.47|0.97||P-value for test of difference between ABT-981 200 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Activity pain||0.97|-0.47|0.489
72584372|NCT03982511|144700110|SUPERIORITY||Mean Difference (Net)|-12.62|STANDARD_ERROR_OF_MEAN|14.84||0.42|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|repeated measures||Difference on difference for actigraphy-recorded sleep time from T2 to T1|effect size: -0.54|||0.42
72413267|NCT02308033|144335206|SUPERIORITY||||||<|0.001|||||||Chi-squared, Corrected|||||||<0.001
72413268|NCT02308033|144335207|SUPERIORITY||||||<|0.001|||||||Chi-squared, Corrected|||Comparison of normal Nugent scores at 7-14 days||||<0.001
72413269|NCT02308033|144335208|SUPERIORITY|||||||0.034|||||||Chi-squared, Corrected|||Comparison of the number of subjects whose reported their symptoms completely resolved||||0.034
72413270|NCT03176693|144335221|EQUIVALENCE|A power analysis was calculated based on findings reported by Weingarten et al. of more frequent episodes of hypotension (defined as difference of mean systolic blood pressure \<30% from baseline) in phenoxybenzamine compared with doxazosin (15.7% versus 5.1%). Using a standard deviation of 16 and 11 (derived from reported interquartile ranges, assuming normal distribution), respectively, to achieve 80% power using an alpha =.05, a total sample size of 56 patients was determined.||||||0.56||||||Threshold for statistical significance = 0.05|Wilcoxon (Mann-Whitney)|||Null hypothesis: hemodynamic instability time will not differ between arms||||.56
72413271|NCT02279641|144335227|NON_INFERIORITY_OR_EQUIVALENCE|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|133.0|||||TWO_SIDED|90.0|111.0|159.0|||Mixed Models Analysis|Fixed effect for treatment and random effects for subjects. GLMSRs are back-transformed to the original scale.||||159|111|
72413272|NCT02279641|144335227|NON_INFERIORITY_OR_EQUIVALENCE|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|67.9|||||TWO_SIDED|90.0|65.2|70.7|||Mixed Models Analysis|Fixed effect for treatment and random effects for subjects. GLMSRs are back-transformed to the original scale.||||70.7|65.2|
72413273|NCT02279641|144335229|NON_INFERIORITY_OR_EQUIVALENCE|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|102.0|||||TWO_SIDED|90.0|93.3|111.0|||Mixed Models Analysis|Fixed effect for treatment and random effects for subjects. GLMSRs are back-transformed to the original scale.||||111|93.3|
72413274|NCT02279641|144335229|NON_INFERIORITY_OR_EQUIVALENCE|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|61.8|||||TWO_SIDED|90.0|58.1|65.7|||Mixed Models Analysis|Fixed effect for treatment and random effects for subjects. GLMSRs are back-transformed to the original scale.||||65.7|58.1|
72413275|NCT02279641|144335229|NON_INFERIORITY_OR_EQUIVALENCE|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|95.9|||||TWO_SIDED|90.0|88.4|104.0|||Mixed Models Analysis|Fixed effect for treatment and random effects for subjects. GLMSRs are back-transformed to the original scale.||||104|88.4|
72552007|NCT02087904|144634294|SUPERIORITY||LS Mean Difference|0.2||||0.498|TWO_SIDED|95.0|-0.42|0.85||P-value for test of difference between ABT-981 25 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Performance pain (before)||0.85|-0.42|0.498
72584373|NCT03982511|144700110|SUPERIORITY||Mean Difference (Net)|-38.83|STANDARD_ERROR_OF_MEAN|16.61||0.04|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|repeated measures||Difference on difference for actigraphy-recorded sleep time from T3 to T1|effect size: -1.56|||0.04
72413276|NCT02279641|144335230|NON_INFERIORITY_OR_EQUIVALENCE|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|103.0|||||TWO_SIDED|90.0|94.9|112.0|||Mixed Models Analysis|Fixed effect for treatment and random effects for subjects. GLMSRs are back-transformed to the original scale.||||112|94.9|
72413277|NCT02279641|144335230|NON_INFERIORITY_OR_EQUIVALENCE|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|61.8|||||TWO_SIDED|90.0|58.1|65.7|||Mixed Models Analysis|Fixed effect for treatment and random effects for subjects. GLMSRs are back-transformed to the original scale.||||65.7|58.1|
72413278|NCT02279641|144335232|NON_INFERIORITY_OR_EQUIVALENCE|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|89.5|||||TWO_SIDED|90.0|81.8|98.0|||Mixed Models Analysis|Fixed effect for treatment and random effects for subjects. GLMSRs are back-transformed to the original scale.||||98.0|81.8|
72413279|NCT02279641|144335232|NON_INFERIORITY_OR_EQUIVALENCE|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|119.0|||||TWO_SIDED|90.0|114.0|125.0|||Mixed Models Analysis|Fixed effect for treatment and random effects for subjects. GLMSRs are back-transformed to the original scale.||||125|114|
72552008|NCT02087904|144634294|SUPERIORITY||LS Mean Difference|0.2||||0.637|TWO_SIDED|95.0|-0.8|0.49||P-value for test of difference between ABT-981 100 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Performance pain (before)||0.49|-0.8|0.637
72584374|NCT03982511|144700111|SUPERIORITY||Mean Difference (Net)|0.08|STANDARD_ERROR_OF_MEAN|0.26||0.77|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|repeated measures||Difference on difference for problematic media use from T2 to T1|effect size: 0.15|||0.77
72413280|NCT02279641|144335233|NON_INFERIORITY_OR_EQUIVALENCE|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|87.5|||||TWO_SIDED|90.0|79.3|96.6|||Mixed Models Analysis|Fixed effect for treatment and random effects for subjects. GLMSRs are back-transformed to the original scale.||||96.6|79.3|
72413281|NCT02279641|144335233|NON_INFERIORITY_OR_EQUIVALENCE|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|193.0|||||TWO_SIDED|90.0|177.0|210.0|||Mixed Models Analysis|Fixed effect for treatment and random effects for subjects. GLMSRs are back-transformed to the original scale.||||210|177|
72413282|NCT02279641|144335233|NON_INFERIORITY_OR_EQUIVALENCE|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|105.0|||||TWO_SIDED|90.0|94.4|117.0|||Mixed Models Analysis|Fixed effect for treatment and random effects for subjects. GLMSRs are back-transformed to the original scale.||||117|94.4|
72413283|NCT02279641|144335236|NON_INFERIORITY_OR_EQUIVALENCE|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|98.7|||||TWO_SIDED|95.0|87.7|111.0|||Mixed Models Analysis|Fixed effect for treatment and random effects for subjects. GLMSRs are back-transformed to the original scale.||||111|87.7|
72584375|NCT03982511|144700111|SUPERIORITY||Mean Difference (Net)|-0.21|STANDARD_ERROR_OF_MEAN|0.28||0.47|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|repeated measures||Difference on difference for problematic media use from T3 to T1|effect size: -0.38|||0.47
72584376|NCT03982511|144700112|SUPERIORITY||Mean Difference (Net)|9.11|STANDARD_ERROR_OF_MEAN|2.76||0.005|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|repeated measures||Difference on difference for child-centered skills from T2 to T1|effect size: 1.65|||0.005
72584377|NCT03982511|144700112|SUPERIORITY||Mean Difference (Net)|8.22|STANDARD_ERROR_OF_MEAN|3.81||0.05|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|repeated measures||Difference on difference for child-centered skills from T3 to T1|effect size: 1.20|||0.05
72584378|NCT03982511|144700113|SUPERIORITY||Mean Difference (Net)|-17.23|STANDARD_ERROR_OF_MEAN|6.93||0.02|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|repeated measures||Difference on difference for PCDI scores from T2 to T1.|effect size: -1.21|||0.02
72584379|NCT03982511|144700113|SUPERIORITY||Mean Difference (Net)|-19.43|STANDARD_ERROR_OF_MEAN|6.4||0.008|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|repeated measures||Difference on difference for PCDI scores from T3 to T1|effect size: -1.57|||0.008
72584380|NCT03982511|144700114|SUPERIORITY||Mean Difference (Net)|-0.25|STANDARD_ERROR_OF_MEAN|0.36||0.5|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|Repeated measures||Difference on difference for pressure to eat scores from T2 to T1|effect size: -0.34|||0.50
72584381|NCT03982511|144700114|SUPERIORITY||Mean Difference (Net)|-0.01|STANDARD_ERROR_OF_MEAN|0.37||0.98|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|repeated measures||Difference on difference for pressure to eat scores from T3 to T1|effect size: -0.01|||0.98
72584382|NCT03982511|144700115|SUPERIORITY||Mean Difference (Net)|-0.46|STANDARD_ERROR_OF_MEAN|0.32||0.17|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|repeated measures||Difference on difference for restrictive feeding scores from T2 to T1|effect size: -0.70|||0.17
72584383|NCT03982511|144700115|SUPERIORITY||Mean Difference (Net)|-0.35|STANDARD_ERROR_OF_MEAN|0.35||0.34|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|repeated measures||Difference on difference for restrictive feeding scores from T3 to T1|effect size: -0.51|||0.34
72584384|NCT03982511|144700116|SUPERIORITY||Mean Difference (Net)|-0.03|STANDARD_ERROR_OF_MEAN|0.23||0.91|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|repeated measures||Difference on difference for emotional feeding scores from T2 to T1|effect size: -0.06|||0.91
72584385|NCT03982511|144700116|SUPERIORITY||Mean Difference (Net)|-0.17|STANDARD_ERROR_OF_MEAN|0.22||0.45|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|repeated measures||Difference on difference for emotional feeding scores from T3 to T1|effect size: -0.40|||0.45
72584386|NCT03982511|144700117|SUPERIORITY||Mean Difference (Net)|-0.47|STANDARD_ERROR_OF_MEAN|0.2||0.03|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|repeated measures||Difference on difference for instrumental feeding scores from T2 to T1.|effect size: -1.12|||0.03
72584387|NCT03982511|144700117|SUPERIORITY||Mean Difference (Net)|-0.55|STANDARD_ERROR_OF_MEAN|0.23||0.03|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|repeated measures||Difference on difference for instrumental feeding scores from T3 to T1|effect size: -1.25|||0.03
72584388|NCT03982511|144700118|SUPERIORITY||Mean Difference (Net)|2.23|STANDARD_ERROR_OF_MEAN|1.06||0.05|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|repeated measures||Difference on difference for active mediation from T2 to T1|effect size: 1.02|||0.05
72584389|NCT03982511|144700118|SUPERIORITY||Mean Difference (Net)|2.5|STANDARD_ERROR_OF_MEAN|1.47||0.11|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|repeated measures||Difference on difference for active mediation scores from T3 to T1|effect size: 0.88|||0.11
72584390|NCT03982511|144700119|SUPERIORITY||Mean Difference (Net)|3.64|STANDARD_ERROR_OF_MEAN|1.0||0.002|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|repeated measures||Difference on difference for restrictive mediation scores from T2 to T1|effect size: 1.77|||0.002
72413284|NCT02279641|144335237|NON_INFERIORITY_OR_EQUIVALENCE|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|95.9|||||TWO_SIDED|95.0|88.4|104.0|||Mixed Models Analysis|Fixed effect for treatment and random effects for subjects. GLMSRs are back-transformed to the original scale.||||104|88.4|
72413285|NCT02279641|144335238|NON_INFERIORITY_OR_EQUIVALENCE|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|95.9|||||TWO_SIDED|95.0|88.4|104.0|||Mixed Models Analysis|Fixed effect for treatment and random effects for subjects. GLMSRs are back-transformed to the original scale.||||104|88.4|
72552009|NCT02087904|144634294|SUPERIORITY||LS Mean Difference|0.3||||0.367|TWO_SIDED|95.0|-0.35|0.94||P-value for test of difference between ABT-981 200 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Performance pain (before)||0.94|-0.35|0.367
72552010|NCT02087904|144634294|SUPERIORITY||LS Mean Difference|0.1||||0.67|TWO_SIDED|95.0|-0.51|0.79||P-value for test of difference between ABT-981 25 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Performance pain (after)||0.79|-0.51|0.67
72552011|NCT02087904|144634294|SUPERIORITY||LS Mean Difference|-0.1||||0.776|TWO_SIDED|95.0|-0.76|0.57||P-value for test of difference between ABT-981 100 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Performance pain (after)||0.57|-0.76|0.776
72552012|NCT02087904|144634294|SUPERIORITY||LS Mean Difference|0.3||||0.387|TWO_SIDED|95.0|-0.37|0.96||P-value for test of difference between ABT-981 200 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Performance pain (after)||0.96|-0.37|0.387
72552013|NCT02087904|144634295|SUPERIORITY||LS Mean Difference|-0.2||||0.661|TWO_SIDED|95.0|-0.86|0.54||P-value for test of difference between ABT-981 25 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||7-day recall period||0.54|-0.86|0.661
72413286|NCT02279641|144335239|NON_INFERIORITY_OR_EQUIVALENCE|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|101.0|||||TWO_SIDED|95.0|86.7|117.0|||Mixed Models Analysis|Fixed effect for treatment and random effects for subjects. GLMSRs are back-transformed to the original scale.||||117|86.7|
72552014|NCT02087904|144634295|SUPERIORITY||LS Mean Difference|-0.6||||0.122|TWO_SIDED|95.0|-1.26|0.15||P-value for test of difference between ABT-981 100 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||7-day recall period||0.15|-1.26|0.122
72552015|NCT02087904|144634295|SUPERIORITY||LS Mean Difference|-0.2||||0.507|TWO_SIDED|95.0|-0.94|0.47||P-value for test of difference between ABT-981 200 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||7-day recall period||0.47|-0.94|0.507
72552016|NCT02087904|144634295|SUPERIORITY||LS Mean Difference|-0.1||||0.892|TWO_SIDED|95.0|-0.85|0.74||P-value for test of difference between ABT-981 25 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Activity pain||0.74|-0.85|0.892
72421545|NCT01181726|144354228|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|97.87|||||TWO_SIDED|90.0|93.22|102.74|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||102.74|93.22|
72552017|NCT02087904|144634295|SUPERIORITY||LS Mean Difference|-0.3||||0.433|TWO_SIDED|95.0|-1.12|0.48||P-value for test of difference between ABT-981 100 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Activity pain||0.48|-1.12|0.433
72552018|NCT02087904|144634295|SUPERIORITY||LS Mean Difference|0.0||||0.92|TWO_SIDED|95.0|-0.84|0.76||P-value for test of difference between ABT-981 200 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Activity pain||0.76|-0.84|0.92
72552019|NCT02087904|144634295|SUPERIORITY||LS Mean Difference|0.0||||0.957|TWO_SIDED|95.0|-0.68|0.71||P-value for test of difference between ABT-981 25 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Performance pain (before)||0.71|-0.68|0.957
72552020|NCT02087904|144634295|SUPERIORITY||LS Mean Difference|-0.4||||0.222|TWO_SIDED|95.0|-1.13|0.26||P-value for test of difference between ABT-981 100 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Performance pain (before)||0.26|-1.13|0.222
72584391|NCT03982511|144700119|SUPERIORITY||Mean Difference (Net)|1.3|STANDARD_ERROR_OF_MEAN|1.08||0.24|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|repeated measures||Difference on difference for restrictive mediation scores from T3 to T1|effect size: 0.63|||0.24
72584392|NCT03982511|144700120|SUPERIORITY||Mean Difference (Net)|0.68|STANDARD_ERROR_OF_MEAN|1.05||0.53|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|repeated measures||Difference on difference for social coviewing from T2 to T1|effect size: 0.31|||0.53
72584393|NCT03982511|144700120|SUPERIORITY||Mean Difference (Net)|0.33|STANDARD_ERROR_OF_MEAN|1.1||0.77|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|repeated measures||Difference on difference for social coviewing from T3 to T1|effect size: 0.15|||0.77
72584394|NCT03982511|144700121|SUPERIORITY||Mean Difference (Net)|0.14|STANDARD_ERROR_OF_MEAN|1.23||0.91|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|repeated measures||Difference on difference for number of screens in the home from T2 to T1|effect size: 0.04|||0.91
72584395|NCT03982511|144700121|SUPERIORITY||Mean Difference (Net)|0.65|STANDARD_ERROR_OF_MEAN|1.36||0.64|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|repeated measures||Difference on difference for number of screens in the home from T3 to T1|effect size: 0.17|||0.64
72584396|NCT03982511|144700121|SUPERIORITY||Mean Difference (Net)|-0.36|STANDARD_ERROR_OF_MEAN|0.34||0.31|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|repeated measures||Difference on difference for number of screens in child bedroom from T2 to T1|effect size: -0.36|||0.31
72584397|NCT03982511|144700121|SUPERIORITY||Mean Difference (Net)|-0.91|STANDARD_ERROR_OF_MEAN|0.39||0.04|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|repeated measures||Difference on difference for number of screens in child bedroom from T3 to T1|effect size: -0.85|||0.04
72552021|NCT02087904|144634295|SUPERIORITY||LS Mean Difference|-0.4||||0.209|TWO_SIDED|95.0|-1.15|0.25||P-value for test of difference between ABT-981 200 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Performance pain (before)||0.25|-1.15|0.209
72552022|NCT02087904|144634295|SUPERIORITY||LS Mean Difference|0.1||||0.813|TWO_SIDED|95.0|-0.62|0.79||P-value for test of difference between ABT-981 25 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Performance pain (after)||0.79|-0.62|0.813
72552023|NCT02087904|144634295|SUPERIORITY||LS Mean Difference|-0.5||||0.135|TWO_SIDED|95.0|-1.25|0.17||P-value for test of difference between ABT-981 100 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Performance pain (after)||0.17|-1.25|0.135
72584398|NCT03982511|144700122|SUPERIORITY||Mean Difference (Net)|-0.5|STANDARD_ERROR_OF_MEAN|0.21||0.03|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided|ANOVA|repeated measures||Difference on difference for TV on during mealtime from T2 to T1|effect size: -1.25|||0.03
72584399|NCT03982511|144700122|SUPERIORITY||Mean Difference (Net)|-0.33|STANDARD_ERROR_OF_MEAN|0.19||0.1|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided|ANOVA|repeated measures||Difference on difference for TV on during mealtime from T3 to T1|effect size: -1.08|||0.10
72552024|NCT02087904|144634295|SUPERIORITY||LS Mean Difference|-0.1||||0.679|TWO_SIDED|95.0|-0.85|0.57||P-value for test of difference between ABT-981 200 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Performance pain (after)||0.57|-0.85|0.679
72552025|NCT02087904|144634296|SUPERIORITY||LS Mean Difference|0.0||||0.978|TWO_SIDED|95.0|-0.76|0.79||P-value for test of difference between ABT-981 25 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||7-day recall period||0.79|-0.76|0.978
72552026|NCT02087904|144634296|SUPERIORITY||LS Mean Difference|0.0||||0.925|TWO_SIDED|95.0|-0.75|0.82||P-value for test of difference between ABT-981 100 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||7-day recall period||0.82|-0.75|0.925
72552027|NCT02087904|144634296|SUPERIORITY||LS Mean Difference|-0.2||||0.659|TWO_SIDED|95.0|-0.96|0.61||P-value for test of difference between ABT-981 200 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||7-day recall period||0.61|-0.96|0.659
72584400|NCT03982511|144700122|SUPERIORITY||Mean Difference (Net)|-0.2|STANDARD_ERROR_OF_MEAN|0.24||0.41|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|repeated measures||Difference on difference for mobile device present during mealtime from T2 to T1|effect size: -0.44|||0.41
72584401|NCT03982511|144700122|SUPERIORITY||Mean Difference (Net)|-0.29|STANDARD_ERROR_OF_MEAN|0.22||0.21|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|repeated measures||Difference on difference for mobile device present during mealtime from T3 to T1|effect size: -0.80|||0.21
72584402|NCT03982511|144700122|SUPERIORITY||Mean Difference (Net)|-0.4|STANDARD_ERROR_OF_MEAN|0.16||0.02|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|repeated measures||Difference on difference for other media present during mealtime from T2 to T1|effect size: -1.29|||0.02
72584403|NCT03982511|144700122|SUPERIORITY||Mean Difference (Net)|-0.22|STANDARD_ERROR_OF_MEAN|0.16||0.2|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|repeated measures||Difference on difference for other media present during mealtime from T3 to T1|effect size: -0.82|||0.20
72552028|NCT02087904|144634296|SUPERIORITY||LS Mean Difference|-0.2||||0.633|TWO_SIDED|95.0|-1.1|0.67||P-value for test of difference between ABT-981 25 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Activity pain||0.67|-1.1|0.633
72552992|NCT02255097|144637044|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||exact binomial distribution|H0: p ≤ 0.05 versus H1: p \> 0.05||Analysis comparing the ORR for pembrolizumab to a fixed efficacy target of 5% using an exact test of binomial distribution||||<0.001
72552993|NCT03956862|144637099|SUPERIORITY||Mean Difference (Net)|-0.2||||0.9499|TWO_SIDED|95.0|-7.6|7.1|||Mixed Models Analysis||GB001 vs. Placebo|||7.1|-7.6|0.9499
72552994|NCT03956862|144637100|SUPERIORITY||Mean Difference (Net)|-0.3||||0.6778|TWO_SIDED|95.0|-1.8|1.2|||ANCOVA||GB001 vs. Placebo|||1.2|-1.8|0.6778
72552995|NCT03956862|144637101|SUPERIORITY||Mean Difference (Net)|0.1||||0.7914|TWO_SIDED|95.0|-0.7|0.9|||Mixed Models Analysis||GB001 vs. Placebo|||0.9|-0.7|0.7914
72552996|NCT03956862|144637102|SUPERIORITY||Hazard Ratio (HR)|0.944||||0.8916|TWO_SIDED|95.0|0.41|2.173|||Regression, Cox||GB001 vs Placebo|||2.173|0.410|0.8916
72552997|NCT03956862|144637103|SUPERIORITY||Mean Difference (Net)|0.191||||0.1635|TWO_SIDED|95.0|-0.077|0.459|||Mixed Models Analysis||GB001 vs. Placebo|||0.459|-0.077|0.1635
72552998|NCT03956862|144637104|SUPERIORITY||Mean Difference (Net)|0.632||||0.1742|TWO_SIDED|95.0|-0.28|1.544|||Mixed Models Analysis||GB001 vs. Placebo|||1.544|-0.280|0.1742
72552999|NCT03956862|144637105|SUPERIORITY||Mean Difference (Net)|0.9||||0.4851|TWO_SIDED|95.0|-1.6|3.4|||ANCOVA||GB001 vs. Placebo|||3.4|-1.6|0.4851
72553000|NCT03956862|144637106|SUPERIORITY||Hazard Ratio (HR)|0.544||||0.3898|TWO_SIDED|95.0|0.136|2.178|||Regression, Cox||GB001 vs Placebo|||2.178|0.136|0.3898
72553001|NCT02129426|144637109|OTHER|t-test comparison of the two groups||||||0.96|||||||t-test, 1 sided|||||||0.96
72553002|NCT02129426|144637110|OTHER|||||||0.52|||||||t-test, 1 sided|||||||0.52
72553003|NCT00850174|144637159|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Geometric Test/Ref Ratio x 100|98.48||||||90.0|88.98|109.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||109.00|88.98|
72553004|NCT00850174|144637160|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Geometric Test/Ref Ratio x 100|102.54||||||90.0|99.19|106.01|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||106.01|99.19|
72553005|NCT00850174|144637161|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Geometric Test/Ref Ratio x 100|102.19||||||90.0|98.78|105.71|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||105.71|98.78|
72553006|NCT00850174|144637162|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Geometric Test/Ref Ratio x 100|100.77||||||90.0|97.03|104.65|||||Results presented for informational purposes only; metabolite not subjected to Bioequivalence criteria.|||104.65|97.03|
72553007|NCT00850174|144637163|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Geometric Test/Ref Ratio x 100|99.94||||||90.0|97.75|102.18|||||Results presented for informational purposes only, metabolite not subjected to bioequivalence criteria.|||102.18|97.75|
72553008|NCT00850174|144637164|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Geometric Test/Ref Ratio x 100|99.8||||||90.0|97.5|102.15|||||Results presented for informational purposes only; metabolite not subjected to bioequivalence criteria.|||102.15|97.50|
72552029|NCT02087904|144634296|SUPERIORITY||LS Mean Difference|-0.3||||0.46|TWO_SIDED|95.0|-1.23|0.56||P-value for test of difference between ABT-981 100 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Activity pain||0.56|-1.23|0.46
72413287|NCT03021187|144335240|SUPERIORITY|This hypothesis was controlled for multiplicity. Results are based on the data from the in-trial observation period. The estimated treatment effect includes the effect of any rescue medication and any effect after premature trial product discontinuation (treatment policy estimand).|Mean treatment difference|-0.5|||<|0.0001|TWO_SIDED|95.0|-0.7|-0.3||Unadjusted two-sided p-value for test of no difference from 0 (superiority).|Pattern mixture model||Oral semaglutide 3mg - Placebo|The analysis was based on a pattern mixture model using multiple imputation to handle missing week 26 data, assuming that data were missing at random within the groups used for imputation. The imputed data sets were analysed using an analysis of covariance (ANCOVA) model with treatment, strata, interaction strata and region as categorical fixed effects and baseline HbA1c value as covariate for each of the 1000 imputed complete data sets, and pooled by Rubin's rule to draw inference.||-0.3|-0.7|< 0.0001
72413288|NCT03021187|144335240|SUPERIORITY|This hypothesis was controlled for multiplicity. Results are based on the data from the in-trial observation period. The estimated treatment effect includes the effect of any rescue medication and any effect after premature trial product discontinuation (treatment policy estimand).|Mean treatment difference|-0.9|||<|0.0001|TWO_SIDED|95.0|-1.1|-0.7||Unadjusted two-sided p-value for test of no difference from 0 (superiority).|Pattern mixture model||Oral semaglutide 7 mg - Placebo|The analysis was based on a pattern mixture model using multiple imputation to handle missing week 26 data, assuming that data were missing at random within the groups used for imputation. The imputed data sets were analysed using an ANCOVA model with treatment, strata, interaction strata and region as categorical fixed effects and baseline HbA1c value as covariate for each of the 1000 imputed complete data sets, and pooled by Rubin's rule to draw inference.||-0.7|-1.1|< 0.0001
72413289|NCT03021187|144335240|SUPERIORITY|This hypothesis was controlled for multiplicity. Results are based on the data from the in-trial observation period. The estimated treatment effect includes the effect of any rescue medication and any effect after premature trial product discontinuation (treatment policy estimand).|Mean treatment difference|-1.2|||<|0.0001|TWO_SIDED|95.0|-1.4|-1.0||Unadjusted two-sided p-value for test of no difference from 0 (superiority).|Pattern mixture model||Oral semaglutide 14 mg - Placebo|The analysis was based on a pattern mixture model using multiple imputation to handle missing week 26 data, assuming that data were missing at random within the groups used for imputation. The imputed data sets were analysed using an ANCOVA model with treatment, strata, interaction strata and region as categorical fixed effects and baseline HbA1c value as covariate for each of the 1000 imputed complete data sets, and pooled by Rubin's rule to draw inference.||-1.0|-1.4|< 0.0001
72413290|NCT03021187|144335240|SUPERIORITY|This hypothesis was not controlled for multiplicity. Results are based on the data from the on-treatment without rescue medication observation period. The estimated treatment effect excludes the effect of any rescue medication and any effect after premature trial product discontinuation (hypothetical estimand).|Mean treatment difference|-0.6|||<|0.0001|TWO_SIDED|95.0|-0.7|-0.4||Unadjusted two-sided p-value for test of no difference from 0 (superiority).|MMRM||Oral semaglutide 3 mg - Placebo|The analysis was based on a mixed model for repeated measurements (MMRM) that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 26. The independent effects were treatment, region, strata and interaction strata as categorical fixed effects and the baseline HbA1c value as a covariate, all nested within visit, and an unstructured residual covariance matrix.||-0.4|-0.7|<0.0001
72413291|NCT03021187|144335240|SUPERIORITY|This hypothesis was not controlled for multiplicity. Results are based on the data from the on-treatment without rescue medication observation period. The estimated treatment effect excludes the effect of any rescue medication and any effect after premature trial product discontinuation (hypothetical estimand).|Mean treatment difference|-1.0|||<|0.0001|TWO_SIDED|95.0|-1.2|-0.8||Unadjusted two-sided p-value for test of no difference from 0 (superiority).|MMRM||Oral semaglutide 7 mg - Placebo|The analysis was based on a MMRM that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 26. The independent effects were treatment, region, strata and the interaction strata as categorical fixed effects and the baseline HbA1c value as a covariate, all nested within visit, and an unstructured residual covariance matrix.||-0.8|-1.2|<0.0001
72421546|NCT01181726|144354229|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|97.96|||||TWO_SIDED|90.0|93.66|102.46|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||102.46|93.66|
72413292|NCT03021187|144335240|SUPERIORITY|This hypothesis was not controlled for multiplicity. Results are based on the data from the on-treatment without rescue medication observation period. The estimated treatment effect excludes the effect of any rescue medication and any effect after premature trial product discontinuation (hypothetical estimand).|Mean treatment difference|-1.4|||<|0.0001|TWO_SIDED|95.0|-1.6|-1.2||Unadjusted two-sided p-value for test of no difference from 0 (superiority).|MMRM||Oral semaglutide 14 mg - Placebo|The analysis was based on a MMRM that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 26. The independent effects were treatment, region, strata and the interaction strata as categorical fixed effects and the baseline HbA1c value as a covariate, all nested within visit, and an unstructured residual covariance matrix.||-1.2|-1.6|<0.0001
72413293|NCT03021187|144335241|SUPERIORITY|This hypothesis was controlled for multiplicity. Results are based on the data from the in-trial observation period. The estimated treatment effect includes the effect of any rescue medication and any effect after premature trial product discontinuation (treatment policy estimand).|Mean treatment difference|-0.9||||0.0392|TWO_SIDED|95.0|-1.8|0.0||Unadjusted two-sided p-value for test of no difference from 0 (superiority).|Pattern mixture model||Oral semaglutide 3 mg - Placebo|The analysis was based on a pattern mixture model using multiple imputation to handle missing week 26 data, assuming that data were missing at random within the groups used for imputation. The imputed data sets were analysed using an ANCOVA model with treatment, strata, interaction strata and region as categorical fixed effects and baseline body weight value as covariate for each of the 1000 imputed complete data sets, and pooled by Rubin's rule to draw inference.||-0.0|-1.8|0.0392
72413294|NCT03021187|144335241|SUPERIORITY|This hypothesis was controlled for multiplicity. Results are based on the data from the in-trial observation period. The estimated treatment effect includes the effect of any rescue medication and any effect after premature trial product discontinuation (treatment policy estimand).|Mean treatment difference|-2.0||||0.0001|TWO_SIDED|95.0|-3.0|-1.0||Unadjusted two-sided p-value for test of no difference from 0 (superiority).|Pattern mixture model||Oral semaglutide 7 mg - Placebo|The analysis was based on a pattern mixture model using multiple imputation to handle missing week 26 data, assuming that data were missing at random within the groups used for imputation. The imputed data sets were analysed using an ANCOVA model with treatment, strata, interaction strata and region as categorical fixed effects and baseline body weight value as covariate for each of the 1000 imputed complete data sets, and pooled by Rubin's rule to draw inference.||-1.0|-3.0|0.0001
72413295|NCT03021187|144335241|SUPERIORITY|This hypothesis was controlled for multiplicity. Results are based on the data from the in-trial observation period. The estimated treatment effect includes the effect of any rescue medication and any effect after premature trial product discontinuation (treatment policy estimand).|Mean treatment difference|-3.3|||<|0.0001|TWO_SIDED|95.0|-4.2|-2.3||Unadjusted two-sided p-value for test of no difference from 0 (superiority).|Pattern mixture model||Oral semaglutide 14 mg - Placebo|The analysis was based on a pattern mixture model using multiple imputation to handle missing week 26 data, assuming that data were missing at random within the groups used for imputation. The imputed data sets were analysed using an ANCOVA model with treatment, strata, interaction strata and region as categorical fixed effects and baseline body weight value as covariate for each of the 1000 imputed complete data sets, and pooled by Rubin's rule to draw inference.||-2.3|-4.2|<0.0001
72413296|NCT03021187|144335241|SUPERIORITY|This hypothesis was not controlled for multiplicity. Results are based on the data from the on-treatment without rescue medication observation period. The estimated treatment effect excludes the effect of any rescue medication and any effect after premature trial product discontinuation (hypothetical estimand).|Mean treatment difference|-0.9||||0.0111|TWO_SIDED|95.0|-1.6|-0.2||Unadjusted two-sided p-value for test of no difference from 0 (superiority).|MMRM||Oral semaglutide 3 mg - Placebo|The analysis was based on a mixed model for repeated measurements (MMRM) that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 26. The independent effects were treatment, region, strata and interaction strata as categorical fixed effects and the baseline HbA1c value as a covariate, all nested within visit, and an unstructured residual covariance matrix.||-0.2|-1.6|0.0111
72413297|NCT03021187|144335241|SUPERIORITY|This hypothesis was not controlled for multiplicity. Results are based on the data from the on-treatment without rescue medication observation period. The estimated treatment effect excludes the effect of any rescue medication and any effect after premature trial product discontinuation (hypothetical estimand).|Mean treatment difference|-2.5|||<|0.0001|TWO_SIDED|95.0|-3.2|-1.8||Unadjusted two-sided p-value for test of no difference from 0 (superiority).|MMRM||Oral semaglutide 7 mg - Placebo|The analysis was based on a MMRM that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 26. The independent effects were treatment, region, strata and the interaction strata as categorical fixed effects and the baseline body weight value as a covariate, all nested within visit, and an unstructured residual covariance matrix.||-1.8|-3.2|<0.0001
72552030|NCT02087904|144634296|SUPERIORITY||LS Mean Difference|-0.2||||0.663|TWO_SIDED|95.0|-1.1|0.7||P-value for test of difference between ABT-981 200 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Activity pain||0.7|-1.1|0.663
72552031|NCT02087904|144634296|SUPERIORITY||LS Mean Difference|-0.1||||0.696|TWO_SIDED|95.0|-0.89|0.59||P-value for test of difference between ABT-981 25 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Performance pain (before)||0.59|-0.89|0.696
72552032|NCT02087904|144634296|SUPERIORITY||LS Mean Difference|-0.4||||0.278|TWO_SIDED|95.0|-1.16|0.34||P-value for test of difference between ABT-981 100 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Performance pain (before)||0.34|-1.16|0.278
72552033|NCT02087904|144634296|SUPERIORITY||LS Mean Difference|-0.4||||0.357|TWO_SIDED|95.0|-1.1|0.4||P-value for test of difference between ABT-981 200 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Performance pain (before)||0.4|-1.1|0.357
72413298|NCT03021187|144335241|SUPERIORITY|This hypothesis was not controlled for multiplicity. Results are based on the data from the on-treatment without rescue medication observation period. The estimated treatment effect excludes the effect of any rescue medication and any effect after premature trial product discontinuation (hypothetical estimand).|Mean treatment difference|-3.7|||<|0.0001|TWO_SIDED|95.0|-4.4|-3.0||Unadjusted two-sided p-value for test of no difference from 0 (superiority).|MMRM||Oral semaglutide 14 mg - Placebo|The analysis was based on a MMRM that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 26. The independent effects were treatment, region, strata and the interaction strata as categorical fixed effects and the baseline body weight value as a covariate, all nested within visit, and an unstructured residual covariance matrix.||-3.0|-4.4|<0.0001
72413299|NCT03021187|144335261|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|0.73||||0.0627|TWO_SIDED|95.0|0.53|1.02||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox|||Time to initiation of additional anti-diabetic medication was analysed using a Cox proportional hazards model with treatment, strata, interaction strata, and region as categorical fixed effects and baseline HbA1c as covariate. Withdrawal for any reason or lost to follow-up contributed to the analysis as events (initiation of additional anti-diabetic medication). Censoring time was one day before planned end of treatment.||1.02|0.53|0.0627
72413300|NCT03021187|144335261|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|0.63||||0.0083|TWO_SIDED|95.0|0.44|0.89||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox|||Time to initiation of additional anti-diabetic medication was analysed using a Cox proportional hazards model with treatment, strata, and region as categorical fixed effects and baseline HbA1c as covariate. Withdrawal for any reason or lost to follow-up contributed to the analysis as events (initiation of additional anti-diabetic medication). Censoring time was one day before planned end of treatment.||0.89|0.44|0.0083
72413301|NCT03021187|144335261|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|0.57||||0.0019|TWO_SIDED|95.0|0.4|0.81||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox|||Time to initiation of additional anti-diabetic medication was analysed using a Cox proportional hazards model with treatment, strata, interaction strata, and region as categorical fixed effects and baseline HbA1c as covariate. Withdrawal for any reason or lost to follow-up contributed to the analysis as events (initiation of additional anti-diabetic medication). Censoring time was one day before planned end of treatment.||0.81|0.40|0.0019
72413302|NCT03021187|144335262|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|0.75||||0.121|TWO_SIDED|95.0|0.53|1.08||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox|||Time to initiation of rescue medication was analysed using a Cox proportional hazards model with treatment, strata, interaction strata, and region as categorical fixed effects and baseline HbA1c as covariate. Censoring time was one day before last day on trial product.||1.08|0.53|0.1210
72413303|NCT03021187|144335262|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|0.48||||0.0007|TWO_SIDED|95.0|0.32|0.74||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox|||Time to initiation of rescue medication was analysed using a Cox proportional hazards model with treatment, strata, interaction strata, and region as categorical fixed effects and baseline HbA1c as covariate. Censoring time was one day before last day on trial product.||0.74|0.32|0.0007
72413304|NCT03021187|144335262|SUPERIORITY||Hazard Ratio (HR)|0.48||||0.0006|TWO_SIDED|95.0|0.31|0.73||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox|||Time to initiation of rescue medication was analysed using a Cox proportional hazards model with treatment, strata, interaction strata, and region as categorical fixed effects and baseline HbA1c as covariate. Censoring time was one day before last day on trial product.||0.73|0.31|0.0006
72413305|NCT01664078|144335277|OTHER|The Intent-to-Treat (ITT) analysis set includes all subjects who had the aortic bifurcate device introduced into the body. This ITT analysis set will be used for all safety and clinical assessment endpoints.||||||0.47|||||||Mixed Models Analysis|||||||0.47
72413306|NCT01422070|144335293|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.63|||<|0.05|TWO_SIDED|95.0|0.45|0.88|||generalized estimating equation|Generalized estimating equation adjusts the confidence interval for the correlation of outcomes within-centre.|The fully adjusted multivariable logistic regression analysis showed an OR of 0.63 in favour of the presence of an intermediate care unit in the hospital|The null hypothesis was that hospital mortality of patients admitted to intensive care units with intermediate care unit in the hospital is similar to that of the patients admitted to intensive care units without intermediate care unit in the hospital||0.88|0.45|<0.05
72584404|NCT03982511|144700123|SUPERIORITY||Mean Difference (Net)|0.42|STANDARD_ERROR_OF_MEAN|0.14||0.009|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|repeated measures||Difference on difference for mealtime task accomplishment scores from T2 to T1|effect size: 1.55|||0.009
72413307|NCT03351049|144335294|SUPERIORITY|||||||0.8|||||||Chi-squared|||Compare the effectiveness of reactive support surfaces with and without low air loss in preventing pressure injuries||||0.8
72584405|NCT03982511|144700123|SUPERIORITY||Mean Difference (Net)|-0.03|STANDARD_ERROR_OF_MEAN|0.15||0.84|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|repeated measures||Difference on difference for mealtime task accomplishment scores from T3 to T1|effect size: -0.13|||0.84
72584406|NCT03982511|144700123|SUPERIORITY||Mean Difference (Net)|0.24|STANDARD_ERROR_OF_MEAN|0.2||0.24|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|repeated measures||Difference on difference for mealtime behavior control scores from T2 to T1|effect size: 0.63|||0.24
72413308|NCT02730819|144335317|SUPERIORITY|||||||0.006|||||||Wilcoxon (Mann-Whitney)|||P-values of 0.05 or lower were considered statistically significant.||||0.006
72413309|NCT02730819|144335318|SUPERIORITY|||||||0.006|||||||Wilcoxon (Mann-Whitney)|||P-values of 0.05 or lower were considered statistically significant.||||0.006
72413310|NCT00932893|144335357|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.487|||<|0.0001||95.0|0.371|0.638||To control family-wise Type 1 error, a step-down procedure was applied in following order: PFS, objective response rate (ORR), overall survival (OS), and disease control rate (DCR). Statistical significance: 1-sided at alpha=0.025.|Log Rank|||P-value was obtained from 1-sided log-rank test stratified by Eastern Cooperative Oncology Group performance status (ECOG PS) score, brain metastases, and prior epidermal growth factor receptor tyrosine kinase inhibitor (EGFR TKI) treatment. The hazard ratio and corresponding 95% confidence interval (CI) from the stratified Cox Proportional Hazards model were also presented.||0.638|0.371|<0.0001
72413311|NCT00932893|144335358|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.854||||0.1145||95.0|0.661|1.104||Statistical significance: 1-sided at alpha=0.025|Log Rank|||P-value was obtained from 1-sided log-rank test stratified by ECOG PS score, brain metastases, and prior EGFR TKI treatment. The hazard ratio and corresponding 95% CI from the stratified Cox proportional hazards model were also presented.||1.104|0.661|0.1145
72413312|NCT00932893|144335360|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|3.394|||<|0.0001||95.0|2.463|4.676||Statistical significance: 2-sided at alpha=0.025.|Cochran-Mantel-Haenszel|||P-value was obtained from Cochran-Mantel-Haenszel (CMH) test stratified by ECOG PS, brain metastases, and prior EGFR TKI treatment. The risk ratio and corresponding 95% CI from the stratified CMH test were also reported.||4.676|2.463|<0.0001
72413313|NCT00932893|144335361|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.502|||<|0.0001||95.0|1.297|1.741||Statistical significance: 2-sided at alpha=0.0004.|Cochran-Mantel-Haenszel|||P-value was obtained from CMH test stratified by ECOG PS, brain metastases, and prior EGFR TKI treatment. The risk ratio and corresponding 95% CI from the stratified CMH test were also reported.||1.741|1.297|<0.0001
72413314|NCT00932893|144335362|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.697|||<|0.0001|TWO_SIDED|95.0|1.368|2.103||Statistical significance: 2-sided at alpha=0.0004.|Cochran-Mantel-Haenszel|||P-value was obtained from CMH test stratified by ECOG PS, brain metastases, and prior EGFR TKI treatment. The risk ratio and corresponding 95% CI from the stratified CMH test were also reported.||2.103|1.368|<0.0001
72413315|NCT00932893|144335368|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.497|||<|0.0001||95.0|0.373|0.661|||Log Rank|||The p-value was obtained from 2-sided unstratified log-rank test. The hazard ratio and corresponding 95% CI from the Cox Proportional Hazards model were also presented.||0.661|0.373|<0.0001
72413316|NCT05349617|144335384|SUPERIORITY||Percent Difference|86.2|||<|0.0001|TWO_SIDED|95.0|80.0|90.3||p-value is from a two-sided chi-square test of equality of seroresponse percentages between groups. Both coprimary endpoints were required to be met for success, so no multiple comparisons were performed.|Chi-squared||Seroresponse rate difference is (PXVX0317 minus placebo).|Day 22||90.3|80|<0.0001
72413317|NCT05349617|144335385|SUPERIORITY||[GMT Ratio]|90.0|||<|0.0001|TWO_SIDED|95.0|69.0|117.0||Both coprimary endpoints were required to be met for success, so no multiple comparisons were performed.|ANOVA|ANOVA model covers site and treatment group as fixed effects, assuming log titers' normality. p-value tests equivalence of mean titers between groups.|Ratio of GMTs is (PXVX0317:placebo).|Day 22||117|69|<0.0001
72413318|NCT05349617|144335391|SUPERIORITY||Percent Difference|79.5|||<|0.0001|TWO_SIDED|95.0|72.3|84.6||Key secondary endpoints were tested hierarchically (Day 15 tested prior to Day 183), such that each was only tested if both coprimary endpoints and prior key secondary endpoints were met, so no multiple comparisons were performed|Chi-squared|p-value is from a two-sided chi-square test of equality of seroresponse percentages between groups.|Seroresponse rate difference is (PXVX0317 minus placebo).|Day 15||84.6|72.3|<0.0001
72552034|NCT02087904|144634296|SUPERIORITY||LS Mean Difference|-0.1||||0.761|TWO_SIDED|95.0|-0.87|0.64||P-value for test of difference between ABT-981 200 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Performance pain (after)||0.64|-0.87|0.761
72552035|NCT02087904|144634296|SUPERIORITY||LS Mean Difference|-0.5||||0.218|TWO_SIDED|95.0|-1.02|0.51||P-value for test of difference between ABT-981 100 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||||0.51|-1.02|0.218
72413319|NCT05349617|144335391|SUPERIORITY||Percent Difference|74.4|||<|0.0001|TWO_SIDED|95.0|67.1|80.1||Key secondary endpoints were tested hierarchically (Day 15 tested prior to Day 183), such that each was only tested if both coprimary endpoints and prior key secondary endpoints were met, so no multiple comparisons were performed|Chi-squared|p-value is from a two-sided chi-square test of equality of seroresponse percentages between groups.|Seroresponse rate difference is (PXVX0317 minus placebo).|Day 183||80.1|67.1|<0.0001
72413320|NCT05349617|144335392|SUPERIORITY||[GMT Ratio]|42.0|||<|0.0001|TWO_SIDED|95.0|32.0|56.0|||ANOVA|ANOVA model covers site and treatment group as fixed effects, assuming log titers' normality. p-value tests equivalence of mean titers between groups.|Ratio of GMTs is (PXVX0317:placebo)|Day 15||56|32|<0.0001
72413321|NCT05349617|144335392|SUPERIORITY||[GMT Ratio]|28.0|||<|0.0001|TWO_SIDED|95.0|22.0|35.0|||ANOVA|ANOVA model covers site and treatment group as fixed effects, assuming log titers' normality. p-value tests equivalence of mean titers between groups.|Ratio of GMTs is (PXVX0317:placebo)|Day 183||35|22|<0.0001
72552036|NCT02087904|144634296|SUPERIORITY||LS Mean Difference|-0.3||||0.513|TWO_SIDED|95.0|-1.02|0.51||P-value for test of difference between ABT-981 200 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Performance pain (after)||0.51|-1.02|0.513
72552037|NCT02087904|144634297|SUPERIORITY||LS Mean Difference|0.1||||0.728|TWO_SIDED|95.0|-0.52|0.75||P-value for test of difference between ABT-981 25 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||||0.75|-0.52|0.728
72584407|NCT03982511|144700123|SUPERIORITY||Mean Difference (Net)|-0.03|STANDARD_ERROR_OF_MEAN|0.15||0.84|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|repeated measures||Difference on difference for mealtime behavior control scores from T3 to T1.|effect size: -0.13|||0.84
72552038|NCT02087904|144634297|SUPERIORITY||LS Mean Difference|-0.4||||0.219|TWO_SIDED|95.0|-1.06|0.24||P-value for test of difference between ABT-981 100 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||||0.24|-1.06|0.219
72552039|NCT02087904|144634297|SUPERIORITY||LS Mean Difference|-0.1||||0.673|TWO_SIDED|95.0|-0.79|0.51||P-value for test of difference between ABT-981 200 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||||0.51|-0.79|0.673
72552040|NCT02087904|144634298|SUPERIORITY||LS Mean Difference|0.0||||0.984|TWO_SIDED|95.0|-0.73|0.71||P-value for test of difference between ABT-981 25 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||||0.71|-0.73|0.984
72552041|NCT02087904|144634298|SUPERIORITY||LS Mean Difference|-0.5||||0.145|TWO_SIDED|95.0|-1.26|0.19||P-value for test of difference between ABT-981 100 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||||0.19|-1.26|0.145
72584408|NCT03982511|144700124|SUPERIORITY||Mean Difference (Net)|-9.5|STANDARD_ERROR_OF_MEAN|2.17||0|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|repeated measures||Difference on difference for ECBI intensity t-scores from T2 to T1|effect size: -1.50|||0.00
72584409|NCT03982511|144700124|SUPERIORITY||Mean Difference (Net)|-7.63|STANDARD_ERROR_OF_MEAN|2.48||0.01|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|repeated measures||Difference on difference for ECBI intensity t-scores from T3 to T1|effect size: -1.12|||0.01
72584410|NCT03982511|144700125|SUPERIORITY||Mean Difference (Net)|-6.93|STANDARD_ERROR_OF_MEAN|2.63||0.02|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|repeated measures||Difference on difference for internalizing symptoms from T2 to T1|effect size: -0.93|||0.02
72584411|NCT03982511|144700125|SUPERIORITY||Mean Difference (Net)|-6.58|STANDARD_ERROR_OF_MEAN|3.56||0.08|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|repeated measures||Difference on difference for internalizing symptoms from T3 to T1|effect size: -0.68|||0.08
72584412|NCT03982511|144700125|SUPERIORITY||Mean Difference (Net)|-6.47|STANDARD_ERROR_OF_MEAN|6.92||0.36|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|repeated measures||Difference on difference for adaptive skills from T2 to T1|effect size: -0.33|||0.36
72552042|NCT02087904|144634298|SUPERIORITY||LS Mean Difference|-0.2||||0.527|TWO_SIDED|95.0|-0.96|0.49||P-value for test of difference between ABT-981 200 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||||0.49|-0.96|0.527
72552043|NCT02087904|144634299|SUPERIORITY||LS Mean Difference|0.1||||0.836|TWO_SIDED|95.0|-0.71|0.87||P-value for test of difference between ABT-981 25 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||||0.87|-0.71|0.836
72552044|NCT02087904|144634299|SUPERIORITY||LS Mean Difference|-0.1||||0.738|TWO_SIDED|95.0|-0.94|0.66||P-value for test of difference between ABT-981 100 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||||0.66|-0.94|0.738
72584413|NCT03982511|144700125|SUPERIORITY||Mean Difference (Net)|-3.57|STANDARD_ERROR_OF_MEAN|8.83||0.69|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|Repeated measures||Difference on difference for adaptive skills from T3 to T1|effect size: -0.15|||0.69
72584414|NCT03982511|144700126|SUPERIORITY||Mean Difference (Net)|35.78|STANDARD_ERROR_OF_MEAN|7.21||0|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|repeated measures||Difference on difference for PSICA intensity scores from T2 to T1 (higher scores indicate better outcomes).|effect size: 1.70|||0.000
72584415|NCT03982511|144700126|SUPERIORITY||Mean Difference (Net)|21.78|STANDARD_ERROR_OF_MEAN|7.64||0.01|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|repeated measures||Difference on difference for PSICA intensity scores from T3 to T1|effect size: 1.04|||0.01
72584416|NCT03982511|144700127|SUPERIORITY||Mean Difference (Net)|0.05|STANDARD_ERROR_OF_MEAN|0.14||0.73|TWO_SIDED|||||Given this is a pilot RCT, primary aim is to estimate effect size for a more fully-powered RCT. P-values will be provided in addition to effect size.|ANOVA|Repeated measures|Effect size: 0.17|Difference on difference from T2 to T1 for BMI z-score||||.73
72552045|NCT02087904|144634299|SUPERIORITY||LS Mean Difference|-0.4||||0.3|TWO_SIDED|95.0|-1.22|0.38||P-value for test of difference between ABT-981 200 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||||0.38|-1.22|0.3
72413322|NCT05349617|144335393|SUPERIORITY||||||<|0.0001||||||GMFI estimates and 95 percent CIs are based on t-statistics assuming a normal distribution of the log fold increase in titer. p-value tests equality of log fold increase in titer between groups.|t-test, 2 sided|||Day 15||||<0.0001
72413323|NCT05349617|144335393|SUPERIORITY||||||<|0.0001||||||GMFI estimates and 95 percent CIs are based on t-statistics assuming a normal distribution of the log fold increase in titer. p-value tests equality of log fold increase in titer between groups.|t-test, 2 sided|||Day 22||||<0.0001
72584417|NCT03982511|144700127|SUPERIORITY||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|0.18||0.98|TWO_SIDED|||||Given this is a pilot RCT, primary aim is to estimate effect size for a more fully-powered RCT. P-values will be provided in addition to effect size.|ANOVA|Repeated measures||Difference on difference for BMI z-scores from T3 to T1.|Effect size: -0.01|||.98
72584418|NCT00568451|144700130|SUPERIORITY_OR_OTHER||Median|12.5|||||ONE_SIDED|95.0|4.5||||Kaplan-Meier||||||4.5|
72552046|NCT02087904|144634300|SUPERIORITY||LS Mean Difference|0.5||||0.992|TWO_SIDED|95.0|-101.59|102.62||P-value for test of difference between ABT-981 25 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Global knee||102.62|-101.59|0.992
72552047|NCT02087904|144634300|SUPERIORITY||LS Mean Difference|3.6||||0.948|TWO_SIDED|95.0|-103.95|111.1||P-value for test of difference between ABT-981 100 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Global knee||111.10|-103.95|0.948
72552048|NCT02087904|144634300|SUPERIORITY||LS Mean Difference|-33.1||||0.523|TWO_SIDED|95.0|-134.76|68.65||P-value for test of difference between ABT-981 200 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Global knee||68.65|-134.76|0.523
72552049|NCT02087904|144634300|SUPERIORITY||LS Mean Difference|4.2||||0.799|TWO_SIDED|95.0|-28.47|36.95||P-value for test of difference between ABT-981 25 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Medial central condyle + plateau||36.95|-28.47|0.799
72552050|NCT02087904|144634300|SUPERIORITY||LS Mean Difference|9.0||||0.609|TWO_SIDED|95.0|-25.62|43.64||P-value for test of difference between ABT-981 100 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Medial central condyle + plateau||43.64|-25.62|0.609
72552051|NCT02087904|144634300|SUPERIORITY||LS Mean Difference|1.6||||0.923|TWO_SIDED|95.0|-30.97|34.19||P-value for test of difference between ABT-981 200 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Medial central condyle + plateau||34.19|-30.97|0.923
72552052|NCT02087904|144634300|SUPERIORITY||LS Mean Difference|2.1||||0.937|TWO_SIDED|95.0|-49.88|54.08||P-value for test of difference between ABT-981 25 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Medial condyle + plateau||54.08|-49.88|0.937
72584419|NCT02535026|144700151|SUPERIORITY_OR_OTHER|||||||0.28|||||||Chi-squared|||ER status association with age groups||||0.280
72552053|NCT02087904|144634300|SUPERIORITY||LS Mean Difference|4.1||||0.882|TWO_SIDED|95.0|-50.68|58.95||P-value for test of difference between ABT-981 100 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Medial condyle + plateau||58.95|-50.68|0.882
72552054|NCT02087904|144634300|SUPERIORITY||LS Mean Difference|13.8||||0.602|TWO_SIDED|95.0|-38.05|65.55||P-value for test of difference between ABT-981 200 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Medial condyle + plateau||65.55|-38.05|0.602
72584420|NCT02535026|144700152|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Chi-squared|||ER status association with nuclear grade.||||<0.001
72552055|NCT02087904|144634301|SUPERIORITY||LS Mean Difference|-41.7||||0.554|TWO_SIDED|95.0|-180.49|97.04||P-value for test of difference between ABT-981 25 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Global knee||97.04|-180.49|0.554
72552056|NCT02087904|144634301|SUPERIORITY||LS Mean Difference|2.7||||0.97|TWO_SIDED|95.0|-140.86|146.31||P-value for test of difference between ABT-981 100 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Global knee||146.31|-140.86|0.97
72552057|NCT02087904|144634301|SUPERIORITY||LS Mean Difference|-26.1||||0.713|TWO_SIDED|95.0|-165.47|113.32||P-value for test of difference between ABT-981 200 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Global knee||113.32|-165.47|0.713
72552058|NCT02087904|144634301|SUPERIORITY||LS Mean Difference|-25.1||||0.272|TWO_SIDED|95.0|-70.12|19.88||P-value for test of difference between ABT-981 25 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Medial central condyle + plateau||19.88|-70.12|0.272
72584421|NCT02535026|144700153|SUPERIORITY_OR_OTHER||||||=|0.03|||||||Chi-squared|||ER status association with lymphovascular invasion.||||=0.03
72584422|NCT02535026|144700154|SUPERIORITY_OR_OTHER||||||=|0.004|||||||Chi-squared|||PR status association with age groups||||=0.004
72584423|NCT02535026|144700155|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Chi-squared|||PR status association with nuclear grade.||||<0.001
72584424|NCT02535026|144700156|SUPERIORITY_OR_OTHER||||||=|0.025|||||||ANOVA|||PR status association with lymphovascular invasion.||||=0.025
72584425|NCT02535026|144700157|SUPERIORITY_OR_OTHER||||||=|0.056|||||||ANOVA|||HER2 status association with age groups.||||=0.056
72584426|NCT02535026|144700158|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Chi-squared|||HER2 status association with nuclear grade.||||<0.001
72584427|NCT02535026|144700159|SUPERIORITY_OR_OTHER||||||=|0.129|||||||Chi-squared|||||||=0.129
72584428|NCT02535026|144700160|SUPERIORITY_OR_OTHER||||||=|0.003|||||||ANOVA|||Breast cancer phenotypes association with age groups.||||=0.003
72584429|NCT02535026|144700161|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA|||Breast cancer phenotypes association with nuclear grades.||||<0.001
72584430|NCT02535026|144700162|SUPERIORITY_OR_OTHER||||||=|0.001|||||||ANOVA|||phenotypes of breast cancer association with lymphovascular invasion.||||=0.001
72413324|NCT05349617|144335393|SUPERIORITY||||||<|0.0001||||||GMFI estimates and 95 percent CIs are based on t-statistics assuming a normal distribution of the log fold increase in titer. p-value tests equality of log fold increase in titer between groups.|t-test, 2 sided|||Day 183||||<0.0001
72584431|NCT02535026|144700163|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA|||phenotypes of breast cancer association with ER status.||||<0.001
72584432|NCT02535026|144700164|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA|||Phenotypes of breast cancer association with PR status.||||<0.001
72584433|NCT02535026|144700165|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA|||phenotypes of breast cancer association with HER2 status.||||<0.001
72584434|NCT02996968|144700184|NON_INFERIORITY|"Non-inferiority was declared if the POUR rate at 1-week with self-discontinuation was no worse than the POUR rate at 1-week with office-discontinuation, by a pre-specified margin of 15%.~A sample size was calculated to be 74 patients in each arm based on the following:~* The estimated POUR requiring indwelling urinary catheter at 1-week postoperative is 16%~* The non-inferiority margin was set at 15%.~* The power was set at 80%"|Proportion Difference|0.002||||0.5|ONE_SIDED|95.0||0.095||2-sample test for equality of proportions with continuity correction|Two proportions Z-test|||||0.095||0.5
72552059|NCT02087904|144634301|SUPERIORITY||LS Mean Difference|11.1||||0.64|TWO_SIDED|95.0|-35.63|57.8||P-value for test of difference between ABT-981 100 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Medial central condyle + plateau||57.8|-35.63|0.64
72552060|NCT02087904|144634301|SUPERIORITY||LS Mean Difference|-11.8||||0.608|TWO_SIDED|95.0|-56.94|33.38||P-value for test of difference between ABT-981 200 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Medial central condyle + plateau||33.38|-56.94|0.608
72552061|NCT02087904|144634301|SUPERIORITY||LS Mean Difference|-40.3||||0.319|TWO_SIDED|95.0|-119.88|39.3||P-value for test of difference between ABT-981 25 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Medial condyle + plateau||39.3|-119.88|0.319
72552062|NCT02087904|144634301|SUPERIORITY||LS Mean Difference|24.4||||0.56|TWO_SIDED|95.0|-58.05|106.91||P-value for test of difference between ABT-981 100 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Medial condyle + plateau||106.91|-58.05|0.56
72584435|NCT03207815|144700188|SUPERIORITY||Difference in Treatment Failure Rate|-30.1||||0.0064|TWO_SIDED|95.0|-56.2|-4.1||P-value was estimated from the Cochran-Mantel-Haenszel (CMH) test, adjusted for the stratification factors.|Cochran-Mantel-Haenszel|Participants with missing values on treatment failure status were analyzed as treatment failures using a nonresponder imputation (NRI) method.||||-4.1|-56.2|0.0064
72584436|NCT03207815|144700189|SUPERIORITY||Stratified Hazard Ratio|0.309||||0.0014|TWO_SIDED|95.0|0.144|0.663||P-value was derived from the log rank test stratified by the stratification factors.|Stratified Log-Rank Test||Stratified hazard ratio (95% confidence interval \[CI\]) were derived from the Cox model stratified by the stratification factors.|||0.663|0.144|0.0014
72584437|NCT03207815|144700190|SUPERIORITY||Least Squares Mean Treatment Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.14||0.355|TWO_SIDED|95.0|-0.4|0.2||P-value was estimated using a repeated measure Analysis of Covariance (ANCOVA) model which included treatment, eye, interaction of treatment and eye, stratification factors and best state value.|Repeated Measure ANCOVA|The repeated measure ANCOVA model was used to control for the clustered observations from each eye of a participant.|Treatment difference in Least Squares (LS)-means (95% CI) were obtained from the repeated measure ANCOVA model.|||0.2|-0.4|0.3550
72584438|NCT03207815|144700191|SUPERIORITY||LS Mean Treatment Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.18||0.0145|TWO_SIDED|95.0|-0.8|-0.1||P-value was estimated using a repeated measure ANCOVA model which included treatment, eye, interaction of treatment and eye, stratification factors and best state value.|Repeated Measure ANCOVA|The repeated measure ANCOVA model was used to control for the clustered observations from each eye of a participant.|Treatment difference in LS-means (95% CI) were obtained from the repeated measure ANCOVA model.|||-0.1|-0.8|0.0145
72584439|NCT03207815|144700192|SUPERIORITY||LS Mean Treatment Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.025||0.0389|TWO_SIDED|95.0|-0.1|0.0||P-value was estimated using a repeated measure ANCOVA model which included treatment, eye, interaction of treatment and eye, stratification factors and best state value.|Repeated Measure ANCOVA|The repeated measure ANCOVA model was used to control for the clustered observations from each eye of a participant.|Treatment difference in LS-means (95% CI) were obtained from the repeated measure ANCOVA model.|||-0.00|-0.10|0.0389
72584440|NCT03207815|144700193|SUPERIORITY||LS Mean Treatment Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.011||0.034|TWO_SIDED|95.0|-0.05|0.0||P-value was estimated using a repeated measure ANCOVA model which included treatment, eye, interaction of treatment and eye, OCT machine, and best state value.|Repeated Measure ANCOVA|The repeated measure ANCOVA model was used to control for the clustered observations from each eye of a participant.|Treatment difference in LS-means (95% CI) were obtained from the repeated measure ANCOVA model.|||-0.00|-0.05|0.0340
72584441|NCT03207815|144700194|SUPERIORITY||Stratified Hazard Ratio|1.193||||0.5893|TWO_SIDED|95.0|0.625|2.277||P-value was derived from the log rank test stratified by the stratification factors.|Stratified Log-Rank Test||Stratified hazard ratio (95% CI) were derived from the Cox model stratified by the stratification factors.|||2.277|0.625|0.5893
72584442|NCT00391768|144700203|SUPERIORITY_OR_OTHER|||||||0.07||95.0|||||Spearman Correlation|||||||0.07
72584443|NCT00391768|144700203|SUPERIORITY_OR_OTHER|||||||0.6||95.0|||||Spearman Correlation|||||||0.60
72584444|NCT00391768|144700203|SUPERIORITY_OR_OTHER|||||||0.27||95.0|||||Spearman Correlation|||||||0.27
72584445|NCT00391768|144700203|SUPERIORITY_OR_OTHER|||||||0.77||95.0|||||Spearman Correlation|||||||0.77
72552063|NCT02087904|144634301|SUPERIORITY||LS Mean Difference|-28.1||||0.489|TWO_SIDED|95.0|-107.97|51.82||P-value for test of difference between ABT-981 200 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Medial condyle + plateau||51.82|-107.97|0.489
72552064|NCT02087904|144634302|SUPERIORITY||LS Mean Difference|0.0||||0.972|TWO_SIDED|95.0|-0.015|0.015||P-value for test of difference between ABT-981 25 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Global knee||0.015|-0.015|0.972
72413325|NCT05349617|144335394|SUPERIORITY||Percent Difference|91.6|||<|0.0001|TWO_SIDED|95.0|86.0|94.6|||Chi-squared|p-value is from a two-sided chi-square test of equality of SNA response percentages between groups.|SNA response rate difference is (PXVX0317 minus placebo).|SNA titers ≥15 at Day 15||94.6|86.0|<0.0001
72413326|NCT05349617|144335394|SUPERIORITY||Percent Difference|94.1|||<|0.0001|TWO_SIDED|95.0|89.2|96.5|||Chi-squared|p-value is from a two-sided chi-square test of equality of seroresponse percentages between groups.|Seroresponse rate difference is (PXVX0317 minus placebo).|SNA titers ≥15 at Day 22||96.5|89.2|<0.0001
72413327|NCT05349617|144335394|SUPERIORITY||Percent Difference|91.8|||<|0.0001|TWO_SIDED|95.0|86.3|94.8|||Chi-squared|p-value is from a two-sided chi-square test of equality of SNA response percentages between groups.|SNA response rate difference is (PXVX0317 minus placebo).|SNA titers ≥15 at Day 183||94.8|86.3|<0.0001
72413328|NCT05349617|144335394|SUPERIORITY||Percent Difference|82.8|||<|0.0001|TWO_SIDED|95.0|75.9|87.5||p-value is from a two-sided chi-square test of equality of SNA response percentages between groups.|Chi-squared||SNA response rate difference is (PXVX0317 minus placebo).|≥4-fold rise over baseline at Day 15||87.5|75.9|<0.0001
72413329|NCT05349617|144335394|SUPERIORITY||Percent Difference|88.3|||<|0.0001|TWO_SIDED|95.0|82.4|92.0|||Chi-squared|p-value is from a two-sided chi-square test of equality of SNA response percentages between groups.|SNA response rate difference is (PXVX0317 minus placebo).|≥4-fold rise over baseline at Day 22||92.0|82.4|<0.0001
72413330|NCT05349617|144335394|SUPERIORITY||Percent Difference|82.0|||<|0.0001|TWO_SIDED|95.0|75.2|86.8|||Chi-squared|p-value is from a two-sided chi-square test of equality of SNA response percentages between groups.|SNA response rate difference is (PXVX0317 minus placebo).|≥4-fold rise over baseline at Day 183||86.8|75.2|<0.0001
72413331|NCT00746954|144335395|SUPERIORITY_OR_OTHER|||||||0.45|TWO_SIDED||||||ANOVA|||Comparisons among groups||||0.45
72413332|NCT01763567|144335409|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.8|STANDARD_DEVIATION|9.5|||TWO_SIDED|||||||||||||
72413333|NCT01763567|144335410|SUPERIORITY_OR_OTHER||percent of events correctly detected|16.7|||||TWO_SIDED|||||||||||||
72413334|NCT01763567|144335411|SUPERIORITY_OR_OTHER||percent of events correctly detected|88.9|||||TWO_SIDED|||||||||||||
72584446|NCT00391768|144700203|SUPERIORITY_OR_OTHER|||||||0.47||95.0|||||Spearman Correlation|||||||0.47
72413335|NCT01763567|144335412|SUPERIORITY_OR_OTHER||% of false alert|85.8|||||TWO_SIDED|||||||||||||
72413336|NCT01763567|144335413|SUPERIORITY_OR_OTHER||% of false alert|56.5|||||TWO_SIDED|||||||||||||
72413337|NCT00566228|144335437|SUPERIORITY||Hazard Ratio (HR)|1.13||||0.69|TWO_SIDED|95.0|0.62|2.08|||Log Rank|||||2.08|0.62|0.690
72413338|NCT00566228|144335440|SUPERIORITY|||||||0.679|||||||Log Rank|||||||0.679
72413339|NCT00492349|144335453|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05|||||||ANCOVA|||Mixed model ANCOVA in which baseline served as the covariate and Smoking status and measurement occasions were between and within-groups factors, respectively.||||<0.05
72413340|NCT00492349|144335454|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05||||||All treatment main and interaction effect p-values were \> 0.05.|ANCOVA|||Mixed model ANCOVA in which baseline CPT Detectability served as the covariate and Smoking status and measurement occasions were between and within-groups factors, respectively.||||>0.05
72584447|NCT00391768|144700203|SUPERIORITY_OR_OTHER|||||||0.96||95.0|||||Spearman Correlation|||||||0.96
72584448|NCT00406367|144700205|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0|||<|0.001|TWO_SIDED|95.0|-1.4|-0.5||No type I-error adjustment was necessary in this study.|ANCOVA|Indepent variables in the model were treatment, baseline JRS-Severity score, gender, age, dose, and pooled center.||The null hypothesis in the analysis of covariance (ANCOVA) model was the absence of difference in the change from baseline in the JRS severity subscore between incobotulinumtoxinA (Xeomin) and placebo. The ANCOVA model was performed 2-sided (type-I error=5 percent) and change from baseline in the JRS Severity subscore assessed by a blinded Independent Rater as dependent variable. The independent variables were treatment, baseline JRS Severity subscore, gender, age, dose group, and pooled center.||-0.5|-1.4|<0.001
72584449|NCT03187301|144700225|NON_INFERIORITY|For each post-dose time point, change from baseline (ΔQTcF) was compared between APL-130277 and placebo (ΔΔQTcF). The hypothesis of no clinical difference was accepted, if all upper limits of the two-sided 90% confidence intervals (CIs) for APL-130277 versus placebo fell below 10 msec.|Least Square (LS) Mean Difference|4.0|STANDARD_ERROR_OF_MEAN|2.11|||TWO_SIDED|90.0|0.5|7.4||||||15 mins post-dose: time-matched, baseline-corrected comparison between APL-130277 and placebo using the ΔΔQTcF approach. The mixed model for repeated measurements (MMRM) included region, gender, planned sequence, period, treatment, time, and interaction between treatment and time as fixed factors, and baseline QTcF as a covariate. The patient nested within sequence was included as a random effect.||7.4|0.5|
72584450|NCT03187301|144700225|NON_INFERIORITY|For each post-dose time point, change from baseline (ΔQTcF) was compared between APL-130277 and placebo (ΔΔQTcF). The hypothesis of no clinical difference was accepted, if all upper limits of the two-sided 90% CIs for APL-130277 versus placebo fell below 10 msec.|Least Square (LS) Mean difference|3.0|STANDARD_ERROR_OF_MEAN|2.11|||TWO_SIDED|90.0|-0.5|6.5||||||30 mins post-dose: time-matched, baseline-corrected comparison between APL-130277 and placebo using the ΔΔQTcF approach. The MMRM included region, gender, planned sequence, period, treatment, time, and interaction between treatment and time as fixed factors, and baseline QTcF as a covariate. The patient nested within sequence was included as a random effect.||6.5|-0.5|
72584451|NCT03187301|144700225|NON_INFERIORITY|For each post-dose time point, change from baseline (ΔQTcF) was compared between APL-130277 and placebo (ΔΔQTcF). The hypothesis of no clinical difference was accepted, if all upper limits of the two-sided 90% CIs for APL-130277 versus placebo fell below 10 msec.|Least Square (LS) Mean Difference|3.7|STANDARD_ERROR_OF_MEAN|2.11|||TWO_SIDED|90.0|0.2|7.2||||||45 mins post-dose: time-matched, baseline-corrected comparison between APL-130277 and placebo using the ΔΔQTcF approach. The MMRM included region, gender, planned sequence, period, treatment, time, and interaction between treatment and time as fixed factors, and baseline QTcF as a covariate. The patient nested within sequence was included as a random effect.||7.2|0.2|
72413341|NCT00492349|144335455|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05|||||||ANCOVA|||Mixed model ANCOVA in which baseline Antisaccade Errors served as the covariate and Smoking status and measurement occasions were between and within-groups factors, respectively.||||<0.05
72552065|NCT02087904|144634302|SUPERIORITY||LS Mean Difference|-0.001||||0.929|TWO_SIDED|95.0|-0.017|0.015||P-value for test of difference between ABT-981 100 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Global knee||0.015|-0.017|0.929
72552066|NCT02087904|144634302|SUPERIORITY||LS Mean Difference|-0.005||||0.543|TWO_SIDED|95.0|-0.02|0.01||P-value for test of difference between ABT-981 200 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Global knee||0.01|-0.02|0.543
72552067|NCT02087904|144634302|SUPERIORITY||LS Mean Difference|0.008||||0.752|TWO_SIDED|95.0|-0.043|0.059||P-value for test of difference between ABT-981 25 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Medial central condyle + plateau||0.059|-0.043|0.752
72552068|NCT02087904|144634302|SUPERIORITY||LS Mean Difference|0.011||||0.691|TWO_SIDED|95.0|-0.042|0.064||P-value for test of difference between ABT-981 100 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Medial central condyle + plateau||0.064|-0.042|0.691
72552069|NCT02087904|144634302|SUPERIORITY||LS Mean Difference|0.01||||0.71|TWO_SIDED|95.0|-0.041|0.06||P-value for test of difference between ABT-981 200 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Medial central condyle + plateau||0.06|-0.041|0.71
72552070|NCT02087904|144634302|SUPERIORITY||LS Mean Difference|0.0||||0.965|TWO_SIDED|95.0|-0.019|0.02||P-value for test of difference between ABT-981 25 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Medial condyle + plateau||0.02|-0.019|0.965
72552071|NCT02087904|144634302|SUPERIORITY||LS Mean Difference|-0.002||||0.885|TWO_SIDED|95.0|-0.022|0.019||P-value for test of difference between ABT-981 100 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Medial condyle + plateau||0.019|-0.022|0.885
72552072|NCT02087904|144634302|SUPERIORITY||LS Mean Difference|0.001||||0.887|TWO_SIDED|95.0|-0.018|0.021||P-value for test of difference between ABT-981 200 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Medial condyle + plateau||0.021|-0.018|0.887
72552073|NCT02087904|144634303|SUPERIORITY||LS Mean Difference|-0.005||||0.619|TWO_SIDED|95.0|-0.024|0.014||P-value for test of difference between ABT-981 25 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Global knee||0.014|-0.024|0.619
72552074|NCT02087904|144634303|SUPERIORITY||LS Mean Difference|-0.001||||0.952|TWO_SIDED|95.0|-0.02|0.019||P-value for test of difference between ABT-981 100 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Global knee||0.019|-0.02|0.952
72552075|NCT02087904|144634303|SUPERIORITY||LS Mean Difference|-0.003||||0.765|TWO_SIDED|95.0|-0.022|0.016||P-value for test of difference between ABT-981 200 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Global knee||0.016|-0.022|0.765
72552076|NCT02087904|144634303|SUPERIORITY||LS Mean Difference|-0.04||||0.258|TWO_SIDED|95.0|-0.11|0.03||P-value for test of difference between ABT-981 25 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Medial central condyle + plateau||0.03|-0.11|0.258
72413342|NCT00414700|144335457|SUPERIORITY_OR_OTHER|||||||0.003|||||||ANCOVA|Adjusted for age, associated lesion(s) and location of lesion||Test for superiority||||0.003
72552077|NCT02087904|144634303|SUPERIORITY||LS Mean Difference|0.023||||0.535|TWO_SIDED|95.0|-0.049|0.094||P-value for test of difference between ABT-981 100 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Medial central condyle + plateau||0.094|-0.049|0.535
72552078|NCT02087904|144634303|SUPERIORITY||LS Mean Difference|-0.006||||0.866|TWO_SIDED|95.0|-0.076|0.064||P-value for test of difference between ABT-981 200 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Medial central condyle + plateau||0.064|-0.076|0.866
72552079|NCT02087904|144634303|SUPERIORITY||LS Mean Difference|-0.012||||0.413|TWO_SIDED|95.0|-0.041|0.017||P-value for test of difference between ABT-981 25 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Medial condyle + plateau||0.017|-0.041|0.413
72552080|NCT02087904|144634303|SUPERIORITY||LS Mean Difference|0.012||||0.445|TWO_SIDED|95.0|-0.018|0.042||P-value for test of difference between ABT-981 100 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Medial condyle + plateau||0.042|-0.018|0.445
72552081|NCT02087904|144634303|SUPERIORITY||LS Mean Difference|-0.003||||0.835|TWO_SIDED|95.0|-0.032|0.026||P-value for test of difference between ABT-981 200 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Medial condyle + plateau||0.026|-0.032|0.835
72552082|NCT02087904|144634304|SUPERIORITY||Response Rate Difference|7.0||||0.311|TWO_SIDED|95.0|-7.3|21.4||P-value for test of difference between each ABT-981 dose group and Placebo was from a Cochran-Mantel-Haenszel test using age group and K-L grade as stratification factors.|Cochran-Mantel-Haenszel|||||21.4|-7.3|0.311
72413343|NCT00414700|144335458|SUPERIORITY_OR_OTHER|||||||0.01|||||||ANCOVA|Adjusted for age, associated lesion(s) and location of lesion.||Test for superiority||||0.010
72413344|NCT00414700|144335459|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin = -9 % points|Mean Difference (Final Values)|1.81|STANDARD_ERROR_OF_MEAN|2.4||||95.0|-3.28|6.9|||ANCOVA|Adjusted for baseline Overall KOOS score, age, associated lesion(s) and location of lesion.||||6.90|-3.28|
72413345|NCT00384085|144335505|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.56||||0.0628|TWO_SIDED|95.0|0.97|2.52||The type I error was controlled by performing a 2-tailed comparison at a p=0.0475 level for superiority testing.|Regression, Logistic|||||2.52|0.97|0.0628
72413346|NCT00384085|144335506|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority of Lantus/Apidra-1 would be established if the upper limit of the 2 sided, 99.75% CI for the difference in the mean change from baseline between Lantus/Apidra-1 and Novolog Mix 70/30 was \<0.5%.|Adjusted Mean of difference|-0.34||||0.0359|TWO_SIDED|95.0|-0.82|0.15||The type I error was controlled by performing a 2-tailed comparison at a p=0.0025 level for noninferiority testing.|Mixed Models Analysis|||||0.15|-0.82|0.0359
72413347|NCT00384085|144335507|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.66||||0.0313|TWO_SIDED|95.0|1.04|2.64||The type I error was controlled by performing a 2-tailed comparison at a p=0.0475 level for superiority testing.|Regression, Logistic|||||2.64|1.04|0.0313
72413348|NCT00384085|144335508|SUPERIORITY_OR_OTHER||Adjusted Mean of difference|-0.31||||0.0565|TWO_SIDED|95.0|-0.63|0.01|||ANCOVA|||||0.01|-0.63|0.0565
72413349|NCT00384085|144335509|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.79||||0.014|TWO_SIDED|95.0|1.12|2.85|||Regression, Logistic|||||2.85|1.12|0.0140
72413350|NCT00384085|144335510|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.02||||0.9268|TWO_SIDED|95.0|0.61|1.71|||Regression, Logistic|||||1.71|0.61|0.9268
72413351|NCT00384085|144335510|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|2.11||||0.0107|TWO_SIDED|95.0|1.19|3.73|||Regression, Logistic|||||3.73|1.19|0.0107
72413352|NCT00384085|144335510|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|2.06||||0.0121|TWO_SIDED|95.0|1.17|3.61|||Regression, Logistic|||||3.61|1.17|0.0121
72413353|NCT04837482|144335527|NON_INFERIORITY|Noninferiority of AGN-190584 was concluded if the lower bound of the 95% CI of the least-square mean difference between AGN-190584 and vehicle was greater than the pre-specified margin of -0.25.|Least-Square (LS) Mean|-0.224|STANDARD_ERROR_OF_MEAN|0.0602||0.0006|TWO_SIDED|95.0|-0.346|-0.103|||Mixed Models Analysis|Linear mixed-effects model with repeated measures||||-0.103|-0.346|0.0006
72413354|NCT00987467|144335532|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||0.002
72413355|NCT02646423|144335543|SUPERIORITY||Risk Ratio (RR)|0.94|||||TWO_SIDED|95.0|0.84|1.05||||||||1.05|0.84|
72413356|NCT02646423|144335544|SUPERIORITY||Risk Ratio (RR)|1.0|||||TWO_SIDED|95.0|0.86|1.16||||||||1.16|0.86|
72413357|NCT02646423|144335545|SUPERIORITY||Mean Difference (Net)|0.01|||||TWO_SIDED|95.0|-0.16|0.19||||||||0.19|-0.16|
72413358|NCT02646423|144335546|SUPERIORITY||Mean Difference (Net)|-0.38|||||TWO_SIDED|95.0|-1.81|1.05||||||||1.05|-1.81|
72413359|NCT02646423|144335547|SUPERIORITY||Mean Difference (Net)|-0.34|||||TWO_SIDED|95.0|-1.96|1.27||||||||1.27|-1.96|
72413360|NCT02646423|144335548|SUPERIORITY||Mean Difference (Net)|0.36|||||TWO_SIDED|95.0|-0.94|1.66||||||||1.66|-0.94|
72413361|NCT02646423|144335549|SUPERIORITY||Mean Difference (Net)|-0.03|||||TWO_SIDED|95.0|-0.09|0.03||||||||0.03|-0.09|
72413362|NCT02646423|144335550|SUPERIORITY||Risk Ratio (RR)|0.83|||||TWO_SIDED|95.0|0.46|1.51||||||||1.51|0.46|
72413363|NCT02646423|144335551|SUPERIORITY||Risk Ratio (RR)|1.0|||||TWO_SIDED|95.0|0.64|1.56||||||||1.56|0.64|
72413364|NCT02646423|144335552|SUPERIORITY||Odds Ratio (OR)|1.34|||||TWO_SIDED|95.0|0.64|2.81||||||||2.81|0.64|
72413365|NCT02646423|144335553|SUPERIORITY||Risk Ratio (RR)|2.0|||||TWO_SIDED|95.0|0.6|6.62||||||||6.62|0.60|
72413366|NCT02646423|144335554|SUPERIORITY||Risk Ratio (RR)|0.99|||||TWO_SIDED|95.0|0.72|1.35||||||||1.35|0.72|
72413367|NCT02646423|144335555|SUPERIORITY||Risk Ratio (RR)|1.13|||||TWO_SIDED|95.0|0.86|1.48||||||||1.48|0.86|
72413368|NCT03073603|144335575|NON_INFERIORITY|We performed a non-inferiority test for the proportions of the drug continuation and drug discontinuation arms experiencing a new MS relapse and/or MRI Brain Lesion over the course of the study duration. The non-inferiority margin used was 8%.|Difference in proportion|0.0753||||0.521|TWO_SIDED|95.0|0.0063|0.15|||Exact binomial test|Exact binomial test for difference in two proportions||We tested the null hypothesis of inferiority with the proportion of disease events (i.e., new MS relapse and/or MRI brain lesion) for the drug discontinuation group being 8% greater than the proportion for the drug continuation group under the alternative that the two rates are equal.||0.1500|0.0063|0.521
72413369|NCT03073603|144335576|SUPERIORITY|||||||0.766|||||||Chi-squared|||||||0.766
72413370|NCT03073603|144335577|SUPERIORITY|||||||0.604|||||||t-test, 2 sided|||||||0.604
72413371|NCT03073603|144335578|SUPERIORITY|||||||0.198|||||||t-test, 2 sided|||||||0.198
72413372|NCT03073603|144335579|SUPERIORITY|||||||0.354|||||||t-test, 2 sided|||||||0.354
72413373|NCT03073603|144335580|SUPERIORITY|||||||0.831|||||||t-test, 2 sided|||||||0.831
72413374|NCT03073603|144335581|SUPERIORITY|||||||0.252|||||||t-test, 2 sided|||||||0.252
72413375|NCT03073603|144335582|SUPERIORITY|||||||0.983|||||||t-test, 2 sided|||||||0.983
72413376|NCT03073603|144335583|SUPERIORITY|||||||0.155|||||||t-test, 2 sided|||||||0.155
72552083|NCT02087904|144634304|SUPERIORITY||Response Rate Difference|5.5||||0.435|TWO_SIDED|95.0|-8.9|19.9||P-value for test of difference between each ABT-981 dose group and Placebo was from a Cochran-Mantel-Haenszel test using age group and K-L grade as stratification factors.|Cochran-Mantel-Haenszel|||||19.9|-8.9|0.435
72552084|NCT02087904|144634304|SUPERIORITY||Response Rate Difference|5.5||||0.435|TWO_SIDED|95.0|-8.9|19.9||P-value for test of difference between each ABT-981 dose group and Placebo was from a Cochran-Mantel-Haenszel test using age group and K-L grade as stratification factors.|Cochran-Mantel-Haenszel|||||19.9|-8.9|0.435
72552085|NCT02087904|144634305|SUPERIORITY||Response Rate Difference|2.4||||0.744|TWO_SIDED|95.0|-11.9|16.8||P-value for test of difference between each ABT-981 dose group and Placebo was from a Cochran-Mantel-Haenszel test using age group and K-L grade as stratification factors.|Cochran-Mantel-Haenszel|||||16.8|-11.9|0.744
72413377|NCT03073603|144335584|SUPERIORITY|||||||0.748|||||||t-test, 2 sided|||||||0.748
72413378|NCT03073603|144335585|SUPERIORITY|||||||0.773|||||||t-test, 2 sided|||||||0.773
72413379|NCT03073603|144335586|SUPERIORITY|||||||0.224|||||||t-test, 2 sided|||||||0.224
72413380|NCT03073603|144335587|SUPERIORITY|||||||0.962|||||||t-test, 2 sided|||||||0.962
72413381|NCT03073603|144335588|SUPERIORITY|||||||0.005|||||||t-test, 2 sided|||||||0.005
72413382|NCT03073603|144335589|SUPERIORITY|||||||0.406|||||||t-test, 2 sided|||||||0.406
72413383|NCT03073603|144335590|SUPERIORITY|||||||0.348|||||||t-test, 2 sided|||||||0.348
72413384|NCT03073603|144335591|SUPERIORITY|||||||0.086|||||||t-test, 2 sided|||||||0.086
72413385|NCT03073603|144335592|SUPERIORITY|||||||0.575|||||||t-test, 2 sided|||||||0.575
72413386|NCT03073603|144335593|SUPERIORITY|||||||0.733|||||||Chi-squared|||||||0.733
72413387|NCT03073603|144335594|SUPERIORITY|||||||0.733|||||||Chi-squared|||||||0.733
72413388|NCT03073603|144335595|SUPERIORITY|||||||0.036|||||||Wilcoxon (Mann-Whitney)|||||||0.036
72413389|NCT01659021|144335596|SUPERIORITY||Hazard Ratio (HR)|0.26|||<|0.0001|TWO_SIDED|95.0|0.18|0.37||P-value is from stratified log-rank test, adjusted for randomization stratification factors (17p deletion/TP53 mutation, immunoglobulin heavy chain variable region (IGHV) mutation, and disease status).|Log Rank||Hazard Ratio and 95% confidence intervals (CI) are from the proportional hazard model, adjusted for randomization stratification factors.|||0.37|0.18|<0.0001
72413390|NCT01659021|144335597|SUPERIORITY||Odds Ratio (OR)|16.85|||<|0.0001|TWO_SIDED|95.0|8.17|34.76||P-value was calculated from the Cochran-Mantel-Haenszel (CMH) Chi-square test stratified by stratification factors.|Cochran-Mantel-Haenszel||Odds ratio and 95% CIs were calculated from the CMH Chi-square test stratified by stratification factors.|||34.76|8.17|<0.0001
72552086|NCT02087904|144634305|SUPERIORITY||Response Rate Difference|4.3||||0.581|TWO_SIDED|95.0|-10.1|18.7||P-value for test of difference between each ABT-981 dose group and Placebo was from a Cochran-Mantel-Haenszel test using age group and K-L grade as stratification factors.|Cochran-Mantel-Haenszel|||||18.7|-10.1|0.581
72552087|NCT02087904|144634305|SUPERIORITY||Response Rate Difference|10.4||||0.146|TWO_SIDED|95.0|-3.5|24.3||P-value for test of difference between each ABT-981 dose group and Placebo was from a Cochran-Mantel-Haenszel test using age group and K-L grade as stratification factors.|Cochran-Mantel-Haenszel|||||24.3|-3.5|0.146
72413391|NCT01659021|144335598|SUPERIORITY||Odds Ratio (OR)|483.16|||<|0.0001|TWO_SIDED|95.0|94.63|2467.02||P-value was calculated from the CMH Chi-square test stratified by stratification factors.|Cochran-Mantel-Haenszel||Odds ratio and 95% CIs were calculated from the CMH Chi-square test stratified by stratification factors.|||2467.02|94.63|<0.0001
72413392|NCT01659021|144335599|SUPERIORITY||Hazard Ratio (HR)|0.79||||0.247|TWO_SIDED|95.0|0.54|1.15||P-value is from stratified log-rank test, adjusted for randomization stratification factors (17p deletion/TP53 mutation, IGHV mutation, and disease status).|Log Rank|||||1.15|0.54|0.247
72413393|NCT01659021|144335600|OTHER||Hazard Ratio (HR)|0.3|||||TWO_SIDED|95.0|0.17|0.51|||||Hazard ratio and 95% CIs were calculated using the Cox proportional hazards model without any adjustments.|||0.51|0.17|
72413394|NCT00407537|144335602|SUPERIORITY_OR_OTHER_LEGACY||LSMean difference|-4.72|||<|0.001|TWO_SIDED|95.0|-5.55|-3.89||Value at a given visit as response. Baseline value, country, and treatment were used as fixed effect and site was used as a random effect and a compound-symmetry (CS) variance-covariance matrix was used for subjects from the same site.|Mixed-effect linear model||Value at a given visit as response. Baseline value, country, and treatment were used as fixed effect and site was used as a random effect and a compound-symmetry (CS) variance-covariance matrix was used for subjects from the same site.|It was estimated that each study site would on average complete 8 evaluable participants, therefore enrolling 164 sites, 1968 participants would provide at least 90% power to detect a 10% relative reduction in the 10-year predicted risk of total CHD at 12 months (as calculated from the Framingham model) from the control arm based on a two-sided t-test with a 5% significance level.||-3.89|-5.55|<0.001
72413395|NCT00407537|144335603|SUPERIORITY_OR_OTHER_LEGACY||LSMean difference|-4.76|||<|0.001|TWO_SIDED|95.0|-5.58|-3.93||Value at a given visit as response. Baseline value, country, and treatment were used as fixed effect and site was used as a random effect and a compound-symmetry (CS) variance-covariance matrix was used for subjects from the same site.|Mixed-effect linear model||Value at a given visit as response. Baseline value, country, and treatment were used as fixed effect and site was used as a random effect and a compound-symmetry (CS) variance-covariance matrix was used for subjects from the same site.|||-3.93|-5.58|<0.001
72552088|NCT02087904|144634306|SUPERIORITY||Response Rate Difference|-1.3||||0.824|TWO_SIDED|95.0|-14.9|12.4||P-value for test of difference between each ABT-981 dose group and Placebo was from a Cochran-Mantel-Haenszel test using age group and K-L grade as stratification factors.|Cochran-Mantel-Haenszel|||||12.4|-14.9|0.824
72413396|NCT00407537|144335604|SUPERIORITY_OR_OTHER_LEGACY||LSMean difference|-0.97|||<|0.001|TWO_SIDED|95.0|-1.23|-0.72||Value at a given visit as response. Baseline value, country, and treatment were used as fixed effect and site was used as a random effect and a compound-symmetry (CS) variance-covariance matrix was used for subjects from the same site.|Mixed-effect linear model||Value at a given visit as response. Baseline value, country, and treatment were used as fixed effect and site was used as a random effect and a compound-symmetry (CS) variance-covariance matrix was used for subjects from the same site.|||-0.72|-1.23|<0.001
72413397|NCT00407537|144335605|SUPERIORITY_OR_OTHER_LEGACY||LSMean difference|-0.88|||<|0.001|TWO_SIDED|95.0|-1.16|-0.59||Value at a given visit as response. Baseline value, country, and treatment were used as fixed effect and site was used as a random effect and a compound-symmetry (CS) variance-covariance matrix was used for subjects from the same site.|Mixed-effect linear model||Value at a given visit as response. Baseline value, country, and treatment were used as fixed effect and site was used as a random effect and a compound-symmetry (CS) variance-covariance matrix was used for subjects from the same site.|||-0.59|-1.16|<0.001
72413398|NCT00407537|144335606|SUPERIORITY_OR_OTHER_LEGACY||LSMean difference|-1.35|||<|0.001|TWO_SIDED|95.0|-1.56|-1.15||Value at a given visit as response. Baseline value, country, and treatment were used as fixed effect and site was used as a random effect and a compound-symmetry (CS) variance-covariance matrix was used for subjects from the same site.|Mixed-effect linear model||Value at a given visit as response. Baseline value, country, and treatment were used as fixed effect and site was used as a random effect and a compound-symmetry (CS) variance-covariance matrix was used for subjects from the same site.|||-1.15|-1.56|<0.001
72413399|NCT00407537|144335607|SUPERIORITY_OR_OTHER_LEGACY||LSMean difference|-1.35|||<|0.001|TWO_SIDED|95.0|-1.57|-1.14||Value at a given visit as response. Baseline value, country, and treatment were used as fixed effect and site was used as a random effect and a compound-symmetry (CS) variance-covariance matrix was used for subjects from the same site.|Mixed-effect linear model||Value at a given visit as response. Baseline value, country, and treatment were used as fixed effect and site was used as a random effect and a compound-symmetry (CS) variance-covariance matrix was used for subjects from the same site.|||-1.14|-1.57|<0.001
72413400|NCT00407537|144335612|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.15|||<|0.007|TWO_SIDED|95.0|-5.42|-0.88|||Mixed-effect linear model|||||-0.88|-5.42|<0.007
72413401|NCT00407537|144335613|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.61|||<|0.011|TWO_SIDED|95.0|-2.86|-0.37|||Mixed-effect linear model|||||-0.37|-2.86|<0.011
72413402|NCT00407537|144335614|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.75|||<|0.001|TWO_SIDED|95.0|-8.0|-3.5|||Mixed-effect linear model|||||-3.50|-8.00|<0.001
72413403|NCT00407537|144335615|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.17|||<|0.001|TWO_SIDED|95.0|-4.42|-1.92|||Mixed-effect linear model|||||-1.92|-4.42|<0.001
72413404|NCT00407537|144335616|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-38.94|||<|0.001|TWO_SIDED|95.0|-43.71|-34.17||Baseline value, country, and treatment were used as fixed effect and site was used as a random effect and a compound-symmetry (CS) variance-covariance matrix was used for subjects from the same site.|Mixed-effect linear model|||TC||-34.17|-43.71|<0.001
72413405|NCT00407537|144335616|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-35.31|||<|0.001|TWO_SIDED|95.0|-39.64|-30.99||Baseline value, country, and treatment were used as fixed effect and site was used as a random effect and a compound-symmetry (CS) variance-covariance matrix was used for subjects from the same site.|Mixed-effect linear model|||LDL||-30.99|-39.64|<0.001
72413406|NCT00407537|144335616|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.99||||0.087|TWO_SIDED|95.0|-0.14|2.13||Baseline value, country, and treatment were used as fixed effect and site was used as a random effect and a compound-symmetry (CS) variance-covariance matrix was used for subjects from the same site.|Mixed-effect linear model|||HDL||2.13|-0.14|0.087
72413407|NCT00407537|144335616|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-23.65|||<|0.001|TWO_SIDED|95.0|-32.6|-14.7||Baseline value, country, and treatment were used as fixed effect and site was used as a random effect and a compound-symmetry (CS) variance-covariance matrix was used for subjects from the same site.|Mixed-effects linear model|||Triglycerides||-14.70|-32.60|<0.001
72413408|NCT00407537|144335617|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-33.07|||<|0.001|TWO_SIDED|95.0|-37.57|-28.56||Baseline value, country, and treatment were used as fixed effect and site was used as a random effect and a compound-symmetry (CS) variance-covariance matrix was used for subjects from the same site.|Mixed-effect linear model|||TC||-28.56|-37.57|<0.001
72584452|NCT03187301|144700225|NON_INFERIORITY|For each post-dose time point, change from baseline (ΔQTcF) was compared between APL-130277 and placebo (ΔΔQTcF). The hypothesis of no clinical difference was accepted, if all upper limits of the two-sided 90% CIs for APL-130277 versus placebo fell below 10 msec.|Least Square (LS) Mean Difference|6.2|STANDARD_ERROR_OF_MEAN|2.11|||TWO_SIDED|90.0|2.7|9.7||||||60 mins post-dose: time-matched, baseline-corrected comparison between APL-130277 and placebo using the ΔΔQTcF approach. The MMRM included region, gender, planned sequence, period, treatment, time, and interaction between treatment and time as fixed factors, and baseline QTcF as a covariate. The patient nested within sequence was included as a random effect.||9.7|2.7|
72413409|NCT00407537|144335617|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-29.83|||<|0.001|TWO_SIDED|95.0|-33.7|-25.95||Baseline value, country, and treatment were used as fixed effect and site was used as a random effect and a compound-symmetry (CS) variance-covariance matrix was used for subjects from the same site.|Mixed-effect linear model|||LDL||-25.95|-33.70|<0.001
72413410|NCT00407537|144335617|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.58||||0.379|TWO_SIDED|95.0|-0.71|1.86||Baseline value, country, and treatment were used as fixed effect and site was used as a random effect and a compound-symmetry (CS) variance-covariance matrix was used for subjects from the same site.|Mixed-effect linear model|||HDL||1.86|-0.71|0.379
72552089|NCT02087904|144634306|SUPERIORITY||Response Rate Difference|0.8||||0.964|TWO_SIDED|95.0|-12.8|14.5||P-value for test of difference between each ABT-981 dose group and Placebo was from a Cochran-Mantel-Haenszel test using age group and K-L grade as stratification factors.|Cochran-Mantel-Haenszel|||||14.5|-12.8|0.964
72413411|NCT00407537|144335617|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-18.27|||<|0.001|TWO_SIDED|95.0|-28.72|-7.81||Baseline value, country, and treatment were used as fixed effect and site was used as a random effect and a compound-symmetry (CS) variance-covariance matrix was used for subjects from the same site.|Mixed-effect linear model|||Triglycerides||-7.81|-28.72|<0.001
72413412|NCT00407537|144335618|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-38.94|||<|0.001|TWO_SIDED|95.0|-43.71|-34.17||Baseline value, country, and treatment were used as fixed effect and site was used as a random effect and a compound-symmetry (CS) variance-covariance matrix was used for subjects from the same site.|Mixed-effect linear model|||TC||-34.17|-43.71|<0.001
72552090|NCT02087904|144634306|SUPERIORITY||Response Rate Difference|2.1||||0.763|TWO_SIDED|95.0|-11.3|15.6||P-value for test of difference between each ABT-981 dose group and Placebo was from a Cochran-Mantel-Haenszel test using age group and K-L grade as stratification factors.|Cochran-Mantel-Haenszel|||||15.6|-11.3|0.763
72413413|NCT00407537|144335618|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-35.31|||<|0.001|TWO_SIDED|95.0|-39.64|-30.99||Baseline value, country, and treatment were used as fixed effect and site was used as a random effect and a compound-symmetry (CS) variance-covariance matrix was used for subjects from the same site.|Mixed-effect linear model|||LDL||-30.99|-39.64|<0.001
72413414|NCT00407537|144335618|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.99||||0.087|TWO_SIDED|95.0|-0.14|2.13||Baseline value, country, and treatment were used as fixed effect and site was used as a random effect and a compound-symmetry (CS) variance-covariance matrix was used for subjects from the same site.|mixed-effect linear model|||HDL||2.13|-0.14|0.087
72413415|NCT00407537|144335618|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-23.65|||<|0.001|TWO_SIDED|95.0|-32.6|-14.7||Baseline value, country, and treatment were used as fixed effect and site was used as a random effect and a compound-symmetry (CS) variance-covariance matrix was used for subjects from the same site.|Mixed-effect linear model|||Triglycerides||-14.70|-32.60|<0.001
72552091|NCT01389102|144634342|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||||||<0.0001
72552092|NCT01389102|144634342|SUPERIORITY_OR_OTHER|||||||0.0099||95.0|||||ANCOVA|||||||0.0099
72552093|NCT01389102|144634342|SUPERIORITY_OR_OTHER|||||||0.0004||95.0|||||ANCOVA|||||||0.0004
72552094|NCT01389102|144634343|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||||||<0.0001
72552095|NCT01389102|144634343|SUPERIORITY_OR_OTHER|||||||0.0406||95.0|||||ANCOVA|||||||0.0406
72552096|NCT01389102|144634343|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||||||<0.0001
72552097|NCT02794974|144634457|SUPERIORITY|||||||0.236|||||||Fisher Exact|||||||0.236
72552098|NCT02794974|144634458|SUPERIORITY|||||||0.018|||||||Wilcoxon (Mann-Whitney)|||||||0.018
72552099|NCT02794974|144634459|SUPERIORITY||Odds Ratio|4.5||||0.209|TWO_SIDED|95.0|0.63|32.2|||Odds Ratio|||||32.2|0.63|0.209
72552100|NCT02794974|144634460|SUPERIORITY||Odds Ratio|2.5||||0.44|TWO_SIDED|95.0|0.49|12.77|||Odds Ratio|||||12.77|0.49|0.44
72552101|NCT02794974|144634461|SUPERIORITY||Odds Ratio|1.88||||0.695|TWO_SIDED|95.0|0.37|9.45|||Odds Ratio|||||9.45|0.37|0.695
72552102|NCT02996682|144634495|SUPERIORITY||||||<|0.001||||||P-value was from the 2-sided exact 1-sample binomial test for the superiority of each treatment group over pre-specified rate of 1%.|2-sided exact 1-sample binomial test|||A sample size of 50 participants in each treatment group would provide over 99% power to detect at least 40% improvement in SVR12 rate from the assumed spontaneous rate of 1% or less using a 2-sided exact 1-sample binomial test at significance level of 0.025.||||<0.001
72552103|NCT02996682|144634495|SUPERIORITY||||||<|0.001||||||P-value was from the 2-sided exact 1-sample binomial test for the superiority of each treatment group over pre-specified rate of 1%.|2-sided exact 1-sample binomial test|||A sample size of 50 participants in each treatment group would provide over 99% power to detect at least 40% improvement in SVR12 rate from the assumed spontaneous rate of 1% or less using a 2-sided exact 1-sample binomial test at significance level of 0.025.||||<0.001
72552104|NCT01536405|144634512|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority evaluation is based on the lower bound of the 2-sided 95% confidence interval (CI) on the risk difference excluding a decrease \>= the prespecified criterion of 10 percentage points|Risk Difference (RD)|4.2|||<|0.001|TWO_SIDED|95.0|1.8|6.8|||Miettinen and Nurminen||RD = MMRV (AMP) - MMRV (2006 process)|||6.8|1.8|<0.001
72552105|NCT01536405|144634512|SUPERIORITY_OR_OTHER||Response rate|97.3|||<|0.001|TWO_SIDED|95.0|95.6|98.4|||One-sample binomial|||Acceptability of the antibody response rate was based on a lower bound of the 95% CI being \>76%||98.4|95.6|<0.001
72552106|NCT01536405|144634513|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority evaluation is based on the lower bound of the 2-sided 95% CI on the risk difference excluding a decrease \>= the prespecified criterion of 5 percentage points|Risk Difference (RD)|-2.2||||0.003|TWO_SIDED|95.0|-4.0|-0.6|||Miettinen and Nurminen||RD = MMRV (AMP) - MMRV (2006 process)|||-0.6|-4.0|0.003
72552107|NCT01536405|144634513|SUPERIORITY_OR_OTHER||Response rate|96.7|||<|0.001|TWO_SIDED|95.0|94.9|97.9|||One-sample binomial|||Acceptability of the antibody response rate was based on a lower bound of the 95% CI being \>90%||97.9|94.9|<0.001
72584453|NCT03187301|144700225|NON_INFERIORITY|For each post-dose time point, change from baseline (ΔQTcF) was compared between APL-130277 and placebo (ΔΔQTcF). The hypothesis of no clinical difference was accepted, if all upper limits of the two-sided 90% CIs for APL-130277 versus placebo fell below 10 msec.|Least Square (LS) Mean Difference|4.8|STANDARD_ERROR_OF_MEAN|2.11|||TWO_SIDED|90.0|1.3|8.3||||||2 hours post-dose: time-matched, baseline-corrected comparison between APL-130277 and placebo using the ΔΔQTcF approach. The MMRM included region, gender, planned sequence, period, treatment, time, and interaction between treatment and time as fixed factors, and baseline QTcF as a covariate. The patient nested within sequence was included as a random effect.||8.3|1.3|
72584454|NCT03187301|144700225|NON_INFERIORITY|For each post-dose time point, change from baseline (ΔQTcF) was compared between APL-130277 and placebo (ΔΔQTcF). The hypothesis of no clinical difference was accepted, if all upper limits of the two-sided 90% CIs for APL-130277 versus placebo fell below 10 msec.|Least Square (LS) Mean Difference|1.8|STANDARD_ERROR_OF_MEAN|2.12|||TWO_SIDED|90.0|-1.7|5.3||||||3 hours post-dose: time-matched, baseline-corrected comparison between APL-130277 and placebo using the ΔΔQTcF approach. The MMRM included region, gender, planned sequence, period, treatment, time, and interaction between treatment and time as fixed factors, and baseline QTcF as a covariate. The patient nested within sequence was included as a random effect.||5.3|-1.7|
72584455|NCT03187301|144700225|NON_INFERIORITY|For each post-dose time point, change from baseline (ΔQTcF) was compared between APL-130277 and placebo (ΔΔQTcF). The hypothesis of no clinical difference was accepted, if all upper limits of the two-sided 90% CIs for APL-130277 versus placebo fell below 10 msec.|Least Sqaure (LS) Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|2.12||||90.0|-4.2|2.8||||||4 hours post-dose: time-matched, baseline-corrected comparison between APL-130277 and placebo using the ΔΔQTcF approach. The MMRM included region, gender, planned sequence, period, treatment, time, and interaction between treatment and time as fixed factors, and baseline QTcF as a covariate. The patient nested within sequence was included as a random effect.||2.8|-4.2|
72552108|NCT01536405|144634514|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority evaluation is based on the lower bound of the 2-sided 95% CI on the risk difference excluding a decrease \>= the prespecified criterion of 5 percentage points|Risk Difference (RD)|1.0|||<|0.001|TWO_SIDED|95.0|-0.7|2.8|||Miettinen and Nurminen||RD = MMRV (AMP) - MMRV (2006 process)|||2.8|-0.7|<0.001
72552109|NCT01536405|144634514|SUPERIORITY_OR_OTHER||Response rate|98.2|||<|0.001|TWO_SIDED|95.0|96.8|99.1|||One-sample binomial|||Acceptability of the antibody response rate was based on a lower bound of the 95% CI being \>90%||99.1|96.8|<0.001
72552110|NCT01536405|144634515|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority evaluation is based on the lower bound of the 2-sided 95% CI on the risk difference excluding a decrease \>= the prespecified criterion of 5 percentage points|Risk Difference (RD)|-0.5|||<|0.001|TWO_SIDED|95.0|-1.8|0.7|||Miettinen and Nurminen||RD = MMRV (AMP) - MMRV (2006 process)|||0.7|-1.8|<0.001
72552111|NCT01536405|144634515|SUPERIORITY_OR_OTHER||Response rate|98.8|||<|0.001|TWO_SIDED|95.0|97.6|99.5|||One-sample binomial|||Acceptability of the antibody response rate was based on a lower bound of the 95% CI being \>90%||99.5|97.6|<0.001
72552112|NCT01536405|144634516|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority evaluation is based on the lower bound of the 2-sided 95% CI on the GMT ratio, excluding a decrease of \>=1.5 fold|GMT ratio|1.2|||<|0.001|TWO_SIDED|95.0|1.1|1.3|||t-test, 2 sided|Analysis was based on log-transformed titers|GMT ratio = MMRV (AMP) / MMRV (2006 process)|||1.3|1.1|<0.001
72552113|NCT01536405|144634517|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority evaluation is based on the lower bound of the 2-sided 95% CI on the GMT ratio, excluding a decrease of \>=1.5 fold|GMT ratio|0.9|||<|0.001|TWO_SIDED|95.0|0.8|1.0|||t-test, 2 sided|Analysis was based on log-transformed titers|GMT ratio = MMRV (AMP) / MMRV (2006 process)|||1.0|0.8|<0.001
72552114|NCT01536405|144634518|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority evaluation is based on the lower bound of the 2-sided 95% CI on the GMT ratio, excluding a decrease of \>=1.5 fold|GMT ratio|1.0|||<|0.001|TWO_SIDED|95.0|0.9|1.1|||t-test, 2 sided|Analysis was based on log-transformed titers|GMT ratio = MMRV (AMP) / MMRV (2006 process)|||1.1|0.9|<0.001
72552115|NCT01536405|144634519|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority evaluation is based on the lower bound of the 2-sided 95% CI on the GMT ratio, excluding a decrease of \>=1.5 fold|GMT ratio|1.0|||<|0.001|TWO_SIDED|95.0|0.9|1.1|||t-test, 2 sided|Analysis was based on log-transformed titers|GMT ratio = MMRV (AMP) / MMRV (2006 process)|||1.1|0.9|<0.001
72552116|NCT01536405|144634520|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.2|||<|0.001|TWO_SIDED|95.0|-1.0|1.3|||Miettinen and Nurminen||RD = MMRV (AMP) - MMRV (2006 process)|||1.3|-1.0|<0.001
72552117|NCT02193165|144634543|SUPERIORITY_OR_OTHER|||||||0.434|TWO_SIDED||||||ANOVA|||Means and standard deviations. 1 factor ANOVA to balance treatment groups to show no difference between groups. Baseline groups are balanced and baseline scores for each intervention group should not be significantly different. Significance will be determined by p\<0.5||||0.434
72552118|NCT02193165|144634544|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||1 factor ANCOVA to determine difference between groups with baseline as covariate. The F statistic is used to determine significance. If significance is found then a Tukey's multiple comparison is done.|ANCOVA|||The null hypothesis states that there is no difference between groups. ANCOVA adjusting for baseline. Significant differences between groups determined by P\<0.05||||<0.001
72552119|NCT02193165|144634545|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||1 factor ANCOVA to determine difference between groups with baseline as covariate. The F statistic is used to determine significance. If significance is found then a Tukey's multiple comparison is done.|ANCOVA|||The null hypothesis states that there is no difference between groups. ANCOVA adjusting for baseline. Significant differences between groups will be determined at P\<0.05||||<0.001
72552120|NCT02193165|144634546|SUPERIORITY_OR_OTHER|||||||0.816|TWO_SIDED||||||ANOVA|||Means and standard deviations. 1 factor ANOVA to balance treatment groups to show no difference between groups. The null hypothesis states that there is no difference between groups. Differences will be noted at P\<0.05. Baseline groups are balanced and baseline scores for each intervention group should not be significantly different||||0.816
72552121|NCT02193165|144634547|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||1 factor ANCOVA to determine difference between groups with baseline as covariate. The F statistic is used to determine significance. If significance is found then a Tukey's multiple comparison is done.|ANCOVA|||The null hypothesis states that there is no difference between groups. ANCOVA adjusting for baseline. Significant differences between intervention groups will be determined @ P\<0.05||||<0.001
72552122|NCT02193165|144634548|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|95.0||||1 factor ANCOVA to determine difference between groups with baseline as covariate. The F statistic is used to determine significance. If significance is found then a Tukey's multiple comparison is done.|ANCOVA|||The null hypothesis states that there is no difference between groups. ANCOVA adjusting for baseline. Significant differences between intervention groups will be determined @ P\<0.05||||<0.001
72552123|NCT03567174|144634586|SUPERIORITY||Mean Difference (Net)|-0.306||||0.125|TWO_SIDED|95.0|-0.697|0.085|||Mixed Models Analysis|||||0.085|-0.697|0.125
72552124|NCT00722124|144634684|SUPERIORITY_OR_OTHER|||||||0.615||95.0|||||Fisher Exact|1 sided||Data were compared between treatment groups using Fisher's Exact test.||||0.615
72552125|NCT00722124|144634684|SUPERIORITY_OR_OTHER|||||||0.826||95.0|||||Fisher Exact|1 sided||Data were compared between treatment groups using Fisher's Exact test.||||0.826
72413416|NCT00407537|144335619|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-33.07|||<|0.001|TWO_SIDED|95.0|-37.57|-28.56||Baseline value, country, and treatment were used as fixed effect and site was used as a random effect and a compound-symmetry (CS) variance-covariance matrix was used for subjects from the same site.|Mixed-effect linear model|||Total cholesterol||-28.56|-37.57|<0.001
72413417|NCT00407537|144335619|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-29.83|||<|0.001|TWO_SIDED|95.0|-33.7|-25.95||Baseline value, country, and treatment were used as fixed effect and site was used as a random effect and a compound-symmetry (CS) variance-covariance matrix was used for subjects from the same site.|Mixed-effect linear model|||LDL||-25.95|-33.70|<0.001
72552126|NCT03785548|144634717|OTHER||Mean Difference (Final Values)|2.851|STANDARD_ERROR_OF_MEAN|2.576||0.27|TWO_SIDED|95.0|-2.241|7.944|||ANCOVA|F(1, 140)=1.225||||7.944|-2.241|0.270
72584456|NCT03187301|144700230|NON_INFERIORITY|15 mins post-dose: time-matched, baseline-corrected comparison between APL-130277 and placebo using the ΔΔQTcB approach. The MMRM included region, gender, planned sequence, period, treatment, time, and interaction between treatment and time as fixed factors, and baseline QTcB as a covariate. The patient nested within sequence was included as a random effect|Least Square (LS) Mean Difference|4.4|STANDARD_ERROR_OF_MEAN|2.54|||TWO_SIDED|90.0|0.3|8.6||||||||8.6|0.3|
72584457|NCT03187301|144700230|NON_INFERIORITY|30 mins post-dose: time-matched, baseline-corrected comparison between APL-130277 and placebo using the ΔΔQTcB approach. The MMRM included region, gender, planned sequence, period, treatment, time, and interaction between treatment and time as fixed factors, and baseline QTcB as a covariate. The patient nested within sequence was included as a random effect|Least Square (LS) Mean Difference|2.5|STANDARD_ERROR_OF_MEAN|2.54|||TWO_SIDED|90.0|-1.6|6.7||||||||6.7|-1.6|
72584458|NCT03187301|144700230|NON_INFERIORITY|45 mins post-dose: time-matched, baseline-corrected comparison between APL-130277 and placebo using the ΔΔQTcB approach. The MMRM included region, gender, planned sequence, period, treatment, time, and interaction between treatment and time as fixed factors, and baseline QTcB as a covariate. The patient nested within sequence was included as a random effect|Least Square (LS) Mean Difference|3.2|STANDARD_ERROR_OF_MEAN|2.54|||TWO_SIDED|90.0|-0.9|7.4||||||||7.4|-0.9|
72584459|NCT03187301|144700230|NON_INFERIORITY|60 mins post-dose: time-matched, baseline-corrected comparison between APL-130277 and placebo using the ΔΔQTcB approach. The MMRM included region, gender, planned sequence, period, treatment, time, and interaction between treatment and time as fixed factors, and baseline QTcB as a covariate. The patient nested within sequence was included as a random effect|Least Square (LS) Mean Difference|3.3|STANDARD_ERROR_OF_MEAN|2.54|||TWO_SIDED|90.0|-0.9|7.5||||||||7.5|-0.9|
72584460|NCT03187301|144700230|NON_INFERIORITY|2 hours post-dose: time-matched, baseline-corrected comparison between APL-130277 and placebo using the ΔΔQTcB approach. The MMRM included region, gender, planned sequence, period, treatment, time, and interaction between treatment and time as fixed factors, and baseline QTcB as a covariate. The patient nested within sequence was included as a random effect|Least Square (LS) Mean Difference|5.0|STANDARD_ERROR_OF_MEAN|2.54|||TWO_SIDED|90.0|0.8|9.2||||||||9.2|0.8|
72584461|NCT03187301|144700230|NON_INFERIORITY|3 hours post-dose: time-matched, baseline-corrected comparison between APL-130277 and placebo using the ΔΔQTcB approach. The MMRM included region, gender, planned sequence, period, treatment, time, and interaction between treatment and time as fixed factors, and baseline QTcB as a covariate. The patient nested within sequence was included as a random effect|Least Square (LS) Mean Difference|4.6|STANDARD_ERROR_OF_MEAN|2.55|||TWO_SIDED|90.0|0.4|8.8||||||||8.8|0.4|
72584462|NCT03187301|144700230|NON_INFERIORITY|4 hours post-dose: time-matched, baseline-corrected comparison between APL-130277 and placebo using the ΔΔQTcB approach. The MMRM included region, gender, planned sequence, period, treatment, time, and interaction between treatment and time as fixed factors, and baseline QTcB as a covariate. The patient nested within sequence was included as a random effect|Least Square (LS) Mean Differeence|2.6|STANDARD_ERROR_OF_MEAN|2.56|||TWO_SIDED|90.0|-1.6|6.9||||||||6.9|-1.6|
72584463|NCT03187301|144700234|NON_INFERIORITY|The hypothesis of assay sensitivity(difference in QTcF time between moxifloxacin and placebo)was evaluated by observing if any of the 4 post-dose evaluation time points had a one-sided(Bonferroni-corrected)95% lower confidence limit which was equal to, or exceeded, 5 msec.|Least Square (LS) Mean Difference|10.0|STANDARD_ERROR_OF_MEAN|2.11|||TWO_SIDED|90.0|5.3|14.8||||||60 mins post-dose: time-matched, baseline-corrected comparison between moxifloxacin and placebo using the ΔΔQTcF approach. The MMRM included region, gender, planned sequence, period, treatment, time, and interaction between treatment and time as fixed factors, and baseline QTcF as a covariate. The patient nested within sequence was included as a random effect.||14.8|5.3|
72584464|NCT03187301|144700234|NON_INFERIORITY|The hypothesis of assay sensitivity(difference in QTcF time between moxifloxacin and placebo)was evaluated by observing if any of the 4 post-dose evaluation time points had a one-sided(Bonferroni-corrected)95% lower confidence limit which was equal to, or exceeded, 5 msec.|Least Square (LS) Mean Difference|12.3|STANDARD_ERROR_OF_MEAN|2.12|||TWO_SIDED|90.0|7.5|17.1||||||2 hours post-dose: time-matched, baseline-corrected comparison between moxifloxacin and placebo using the ΔΔQTcF approach. The MMRM included region, gender, planned sequence, period, treatment, time, and interaction between treatment and time as fixed factors, and baseline QTcF as a covariate. The patient nested within sequence was included as a random effect.||17.1|7.5|
72552127|NCT03785548|144634718|OTHER||Mean Difference (Final Values)|0.141|STANDARD_ERROR_OF_MEAN|3.098||0.964|TWO_SIDED|95.0|-5.983|6.266|||ANCOVA|F(1, 140)=0.002||||6.266|-5.983|0.964
72552128|NCT05327491|144634721|EQUIVALENCE|It was concluded that the test treatment is bioequivalent to the reference treatment if the 90% CI for the ratio of Geometric Least Squares Mean (GLSM) was completely contained within the predefined interval of (0.8000, 1.2500).|Ratio of GLSM|0.962|||||TWO_SIDED|90.0|0.88|1.053||||||||1.053|0.880|
72413418|NCT00407537|144335619|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.58||||0.379|TWO_SIDED|95.0|-0.71|1.86||Baseline value, country, and treatment were used as fixed effect and site was used as a random effect and a compound-symmetry (CS) variance-covariance matrix was used for subjects from the same site.|mixed-effect linear model|||HDL||1.86|-0.71|0.379
72413419|NCT00407537|144335619|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-18.27|||<|0.001|TWO_SIDED|95.0|-28.72|-7.81||Baseline value, country, and treatment were used as fixed effect and site was used as a random effect and a compound-symmetry (CS) variance-covariance matrix was used for subjects from the same site.|Mixed-effect linear model|||Triglycerides||-7.81|-28.72|<0.001
72413420|NCT00782340|144335627|SUPERIORITY_OR_OTHER|||||||0.003||||||Statistical analysis plan involved a hierarchical assessment of secondary endpoints to prevent inflation of type I errors.|ANCOVA|ANCOVA model that includes treatment as a factor and baseline OHQ composite score as a co-variate.||||||0.003
72552129|NCT05327491|144634722|EQUIVALENCE|It was concluded that the test treatment is bioequivalent to the reference treatment if the 90% CI for the ratio of Geometric Least Squares Mean (GLSM) was completely contained within the predefined interval of (0.8000, 1.2500).|Ratio of GLSM|0.968|||||TWO_SIDED|90.0|0.907|1.033||||||||1.033|0.907|
72552130|NCT05327491|144634723|EQUIVALENCE|It was concluded that the test treatment is bioequivalent to the reference treatment if the 90% CI for the ratio of Geometric Least Squares Mean (GLSM) was completely contained within the predefined interval of (0.8000, 1.2500).|Ratio of GLSM|0.967|||||TWO_SIDED|90.0|0.908|1.029||||||||1.029|0.908|
72552131|NCT01171989|144634730|NON_INFERIORITY|Criterion for evaluation of Non-inferiority: the upper limit of Standardised asymptotic 95% confidence interval lower or equal to 10%|Difference in percentage|0.0|||||TWO_SIDED|95.0|-3.27|2.84||||||Difference in percentage anti-PRP ≥ 0.15 μg/mL||2.84|-3.27|
72413421|NCT00782340|144335628|SUPERIORITY_OR_OTHER|||||||0.003||||||Statistical analysis plan involved a hierarchical assessment of secondary endpoints to prevent inflation of type I errors.|ANCOVA|ANCOVA model that includes treatment as a factor and baseline OHDAS composite score as a co-variate.||||||0.003
72413422|NCT00782340|144335629|SUPERIORITY_OR_OTHER|||||||0.01||||||Statistical analysis plan involved a hierarchical assessment of secondary endpoints to prevent inflation of type I errors.|ANCOVA|ANCOVA model including a factor for randomized treatment along with the OHSA composite value at randomization as a covariate.||||||0.010
72413423|NCT00782340|144335630|SUPERIORITY_OR_OTHER|||||||0.003||||||Statistical analysis plan involved a hierarchical assessment of secondary endpoints to prevent inflation of type I errors.|Mantel Haenszel|Mantel-Haenszel statistic comparing treatment groups based on rank statistics adjusted for the covariate OHSA Item 1 value at baseline.||||||0.003
72413424|NCT00782340|144335631|SUPERIORITY_OR_OTHER|||||||0.009||||||Statistical analysis plan involved a hierarchical assessment of secondary endpoints to prevent inflation of type I errors.|ANCOVA|ANCOVA model including a factor for randomized treatment along with the OHSA composite value at randomization as a covariate.||||||0.009
72552132|NCT01171989|144634731|NON_INFERIORITY|Criterion for evaluation of Non-inferiority: the upper limit of Standardised asymptotic 95% confidence interval lower or equal to 10%|Difference in percentage|0.0|||||TWO_SIDED|95.0|-3.27|2.86||||||Difference between groups for rSBA-MenC ≥1:8||2.86|-3.27|
72552133|NCT01171989|144634731|NON_INFERIORITY|Criterion for evaluation of Non-inferiority: the upper limit of Standardised asymptotic 95% confidence interval lower or equal to 10%|Difference in percentage|0.0|||||TWO_SIDED|95.0|-3.02|2.86||||||Difference between groups for rSBA-MenC ≥1:8||2.86|-3.02|
72584465|NCT03187301|144700234|NON_INFERIORITY|The hypothesis of assay sensitivity(difference in QTcF time between moxifloxacin and placebo)was evaluated by observing if any of the 4 post-dose evaluation time points had a one-sided(Bonferroni-corrected)95% lower confidence limit which was equal to, or exceeded, 5 msec.|Least Square (LS) Mean Difference|10.9|STANDARD_ERROR_OF_MEAN|2.12|||TWO_SIDED|90.0|6.1|15.7||||||3 hours post-dose: time-matched, baseline-corrected comparison between moxifloxacin and placebo using the ΔΔQTcF approach. The MMRM included region, gender, planned sequence, period, treatment, time, and interaction between treatment and time as fixed factors, and baseline QTcF as a covariate. The patient nested within sequence was included as a random effect.||15.7|6.1|
72413425|NCT00782340|144335632|SUPERIORITY_OR_OTHER||||||<|0.001||||||Statistical analysis plan involved a hierarchical assessment of secondary endpoints to prevent inflation of type I errors.|Mantel Haenszel|Mantel-Haenszel statistic comparing treatment groups based on rank statistics adjusted for the covariate OHSA Item 1 value at baseline.||||||<0.001
72413426|NCT00782340|144335633|SUPERIORITY_OR_OTHER|||||||0.327||||||Statistical analysis plan involved a hierarchical assessment of secondary endpoints to prevent inflation of type I errors. As the this endpoint was not positive, no additional statistical analyses will be performed on secondary endpoints.|Fisher Exact|||||||0.327
72413427|NCT02830594|144335657|EQUIVALENCE|Specifically, a sample-size of 14 patients will have 80% power to detect an effect size of 0.71 using a paired t-test with a 0.05 one-sided significance level. The effect size is the mean difference divided by the standard deviation of the difference.||||||0.6|||||||Paired t Test|||||||0.60
72552134|NCT00105196|144634807|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.73|||<|0.001||95.0|-5.44|-2.02|||t-test, 2 sided|||The sample size for the study was based on the primary outcome measure. The study was powered at 90% to detect a treatment difference between adjunctive aripiprazole and adjunctive placebo of 3.75, assuming a standard deviation of 10.5 and a two-sided alpha level of 0.05. The null-hypothesis was the lack of a treatment difference.||-2.02|-5.44|<0.001
72552135|NCT00105196|144634808|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.42||||0.075||95.0|-0.88|0.04|||t-test, 2 sided|||To protect the overall (primary and key secondary efficacy analysis) alpha level of 0.05, for this key secondary endpoint a hierarchical testing procedure was followed such that formal testing would take place conditional on the primary efficacy analysis showing a statistically significant difference.||0.04|-0.88|0.075
72552136|NCT00105196|144634809|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.53||||0.052||95.0|-1.06|0.0||No adjustment for multiple comparisons was implemented for this secondary endpoint.|t-test, 2 sided|||||0.00|-1.06|0.052
72552137|NCT00105196|144634810|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.57||||0.037||95.0|-1.1|-0.03||No adjustment for multiple comparisons was implemented for this secondary endpoint.|t-test, 2 sided|||||-0.03|-1.10|0.037
72552138|NCT00105196|144634811|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.08||||0.792||95.0|-0.67|0.51||No adjustment for multiple comparisons was implemented for this secondary endpoint.|t-test, 2 sided|||||0.51|-0.67|0.792
72552139|NCT00105196|144634812|SUPERIORITY_OR_OTHER||Ratio of response|1.74|||<|0.001||95.0|1.31|2.32||No adjustment for multiple comparisons was implemented for this secondary endpoint.|CMH General Association Test||aripiprazole/placebo|||2.32|1.31|<0.001
72552140|NCT00105196|144634813|SUPERIORITY_OR_OTHER||Ratio of response|1.43|||<|0.001||95.0|1.17|1.74||No adjustment for multiple comparisons was implemented for this secondary endpoint.|ANCOVA||aripiprazole/placebo|||1.74|1.17|<0.001
72584466|NCT03187301|144700234|NON_INFERIORITY|The hypothesis of assay sensitivity(difference in QTcF time between moxifloxacin and placebo)was evaluated by observing if any of the 4 post-dose evaluation time points had a one-sided(Bonferroni-corrected)95% lower confidence limit which was equal to, or exceeded, 5 msec.|Least Square (LS) Mean Difference|9.0|STANDARD_ERROR_OF_MEAN|2.12|||TWO_SIDED|90.0|4.2|13.8||||||4 hours post-dose: time-matched, baseline-corrected comparison between moxifloxacin and placebo using the ΔΔQTcF approach. The MMRM included region, gender, planned sequence, period, treatment, time, and interaction between treatment and time as fixed factors, and baseline QTcF as a covariate. The patient nested within sequence was included as a random effect.||13.8|4.2|
72584467|NCT02158585|144700242|SUPERIORITY||Mean Difference (Final Values)|8.93||||0.5618|TWO_SIDED|95.0|-3.49|21.35|||Wilcoxon (Mann-Whitney)|||Null hypothesis: no difference between groups in average total number of vertigo attacks||21.35|-3.49|0.5618
72413428|NCT02830594|144335658|EQUIVALENCE|Specifically, a sample-size of 14 patients will have 80% power to detect an effect size of 0.71 using a paired t-test with a 0.05 one-sided significance level. The effect size is the mean difference divided by the standard deviation of the difference.||||||0.87|||||||Paired t Test|||||||0.87
72552141|NCT00105196|144634814|SUPERIORITY_OR_OTHER||Ratio of remission|1.95|||<|0.001||95.0|1.36|2.8||No adjustment for multiple comparisons was implemented for this secondary endpoint.|CMH General Association Test||aripiprazole/placebo|||2.80|1.36|<0.001
72552142|NCT01382719|144634815|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0215|STANDARD_DEVIATION|2.9|<|0.05|TWO_SIDED|95.0|0.0|1.0|||Van Elteren|||||1.0|0.0|<0.05
72552143|NCT01382719|144634815|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0012|STANDARD_DEVIATION|0.0012|<|0.05|TWO_SIDED|95.0|0.0|0.06|||Van Elteren|||||0.06|0.00|<0.05
72552144|NCT01382719|144634816|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0496|||<|0.05|||||||ANCOVA|||||||<0.05
72552145|NCT01382719|144634817|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0079|||<|0.05|TWO_SIDED|95.0|0.0|1.0|||Van Elteren|||||1.00|0.00|<0.05
72552146|NCT01382719|144634818|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0012|||<|0.05|||||||Van Elteren|||||||<0.05
72552147|NCT01382719|144634819|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0013|||<|0.05|||||||Van Elteren|||||||<0.05
72584468|NCT02158585|144700243|SUPERIORITY|||||||0.03429|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: no difference between average total number of vertigo attacks in pre-treatment and treatment||||0.03429
72413429|NCT02830594|144335659|EQUIVALENCE|Specifically, a sample-size of 14 patients will have 80% power to detect an effect size of 0.71 using a paired t-test with a 0.05 one-sided significance level. The effect size is the mean difference divided by the standard deviation of the difference.||||||0.64|||||||Paired t Test|||||||0.64
72413430|NCT01764945|144335664|NON_INFERIORITY_OR_EQUIVALENCE|investigation of relative bioavailability (no formal testing).|Geometric Mean Ratio|82.58|STANDARD_DEVIATION|19.7|||TWO_SIDED|90.0|73.69|92.54|||ANOVA||the standard deviation is actually the geometric coefficient of variation.|"relative bioavailability comparison of 40 mg faldaprevir soft gelatine capsules compared with the equivalent dose of an oral solution.~(treatment B : treatment A)."||92.54|73.69|
72413431|NCT01764945|144335664|NON_INFERIORITY_OR_EQUIVALENCE|investigation of relative bioavailability (no formal testing).|Geometric Mean Ratio|83.34|STANDARD_DEVIATION|22.2|||TWO_SIDED|90.0|73.65|94.3|||ANOVA||the standard deviation is actually the geometric coefficient of variation.|"relative bioavailability comparison of 40 mg faldaprevir soft gelatine capsules compared with the equivalent dose of an oral solution.~(treatment C : treatment A)."||94.30|73.65|
72584469|NCT02158585|144700244|SUPERIORITY||Mean Difference (Net)|4.57||||0.0092|TWO_SIDED|95.0|0.85|8.29|||Wilcoxon (Mann-Whitney)|||Null hypothesis: no difference in total average number of vertigo attacks during 3 week time periods||8.29|0.85|0.0092
72584470|NCT02158585|144700247|SUPERIORITY||Median Difference (Final Values)|11.14||||0.0385|TWO_SIDED|95.0|-15.64|37.92|||Wilcoxon (Mann-Whitney)|||||37.92|-15.64|0.0385
72584471|NCT02375971|144700293|SUPERIORITY|The primary efficacy variable was treatment success, defined as the absence of active ROP and absence of unfavorable structural outcomes in both eyes 24 weeks after starting study treatment.|Odds Ratio (OR)|2.19||||0.0254|TWO_SIDED|95.0|0.9932|4.8235|||Cochran-Mantel-Haenszel|||||4.8235|0.9932|0.0254
72584472|NCT00833105|144700365|SUPERIORITY_OR_OTHER||||||<|0.025|TWO_SIDED||||||Mixed Models Analysis|Random subject effect||||||<0.025
72584473|NCT00833105|144700366|SUPERIORITY_OR_OTHER|||||||0.299|TWO_SIDED||||||Mixed Models Analysis|Random subject effect||||||0.299
72584474|NCT00833105|144700367|SUPERIORITY_OR_OTHER|||||||0.459|TWO_SIDED||||||Mixed Models Analysis|Random subject effect||||||0.459
72584475|NCT00833105|144700368|SUPERIORITY_OR_OTHER|||||||0.343|TWO_SIDED||||||Mixed Models Analysis|Random subject effect||||||0.343
72584476|NCT00833105|144700369|SUPERIORITY_OR_OTHER|||||||0.951|TWO_SIDED||||||Mixed Models Analysis|Random subject effects||||||0.951
72584477|NCT00833105|144700370|SUPERIORITY_OR_OTHER|||||||0.371|TWO_SIDED||||||Mixed Models Analysis|Random subject effect||||||0.371
72413432|NCT01764945|144335664|NON_INFERIORITY_OR_EQUIVALENCE|investigation of relative bioavailability (no formal testing).|Geometric Mean Ratio|83.92|STANDARD_DEVIATION|19.6|||TWO_SIDED|90.0|74.69|94.28|||ANOVA||the standard deviation is actually the geometric coefficient of variation.|"relative bioavailability comparison of 40 mg faldaprevir soft gelatine capsules compared with the equivalent dose of an oral solution.~(treatment D : treatment A)."||94.28|74.69|
72552148|NCT01382719|144634820|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1161|||<|0.05|||||||Van Elteren|||||||<0.05
72552149|NCT01382719|144634821|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0133|||<|0.05|||||||ANCOVA|||||||<0.05
72552150|NCT00624065|144634886|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.968||||0.8822||95.0|0.63|1.49|||Regression, Logistic|||||1.49|0.63|0.8822
72584478|NCT00833105|144700371|SUPERIORITY_OR_OTHER|||||||0.164|TWO_SIDED||||||Mixed Models Analysis|Random subject effect||||||0.164
72584479|NCT00833105|144700372|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||Wilcoxon Signed-Rank|No multiple comparison procedure||Pre-training score is average of a total of 9 efforts, including 3 efforts from the first 3 days of training. Post-training score is average of a total of 9 efforts, including 3 efforts from the last 3 days of training.||||<0.01
72552151|NCT00904345|144634890|OTHER||||||||||||||||||Estimates of proportion event-free at 1 and 2 years calculated using Kaplan-Meier methods, and the 2-sided, 95% confidence intervals were calculated by the Greenwood method. All analyses were performed using SAS v9.4 software and R version 3.5.2.|||
72552152|NCT00904345|144634891|OTHER||||||||||||||||||Survival proportion estimates at 1 and 2 years were calculated using Kaplan-Meier methods, and the 2-sided, 95% confidence intervals calculated by the Greenwood method. All analyses were performed using SAS v9.4 software and R version 3.5.2.|||
72552153|NCT00904345|144634895|OTHER||||||||||||||||||Estimates of proportion LRP event-free at 1 and 2 years were calculated using Kaplan-Meier methods, and the 2-sided, 95% confidence intervals calculated by the Greenwood method. All analyses were performed using SAS v9.4 software and R version 3.5.2.|||
72552154|NCT01629381|144634897|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|-5.3||||0.03|TWO_SIDED|95.0|-11.3|-0.4|||Fisher Exact|||||-0.4|-11.3|0.03
72552155|NCT01629381|144634899|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|-5.3||||0.03|TWO_SIDED|95.0|-11.7|-0.1|||Fisher Exact|||||-0.1|-11.7|0.03
72552156|NCT01629381|144634900|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|-2.0||||0.53|TWO_SIDED|95.0|-8.0|3.7|||Fisher Exact|||||3.7|-8.0|0.53
72552157|NCT01390844|144634907|SUPERIORITY_OR_OTHER||Difference in Percentage|34.63|||<|0.0001|TWO_SIDED|95.0|20.24|47.18|||Miettinen and Numinen|||Between-Group Comparison||47.18|20.24|<0.0001
72552158|NCT01390844|144634908|SUPERIORITY_OR_OTHER||Difference in Percentage|33.83||||0.0063|TWO_SIDED|95.0|10.15|52.18|||Miettinen and Numinen|||Between-Group Comparison||52.18|10.15|0.0063
72552159|NCT01390844|144634909|SUPERIORITY_OR_OTHER||Difference in Percentage|35.05|||<|0.0001|TWO_SIDED|95.0|20.51|47.72|||Miettinen and Numinen|||Between-Group Comparison||47.72|20.51|<0.0001
72552160|NCT01390844|144634910|SUPERIORITY_OR_OTHER||Difference in Percentage|33.18||||0.0086|TWO_SIDED|95.0|8.96|51.83|||Miettinen and Numinen|||Between-Group Comparison||51.83|8.96|0.0086
72552161|NCT01390844|144634911|SUPERIORITY_OR_OTHER||Difference in Percentage|29.08|||<|0.001|TWO_SIDED|95.0|15.26|42.22|||Miettinen and Nurminen|||Between-Group Comparison||42.22|15.26|<0.001
72413433|NCT01764945|144335664|NON_INFERIORITY_OR_EQUIVALENCE|investigation of relative bioavailability (no formal testing).|Geometric Mean Ratio|92.9|STANDARD_DEVIATION|10.5|||TWO_SIDED|90.0|88.94|97.04|||ANOVA||the standard deviation is actually the geometric coefficient of variation.|"relative bioavailability comparison of 120 mg faldaprevir soft gelatine capsules compared with the equivalent dose of an oral solution.~(treatment F : treatment E)."||97.04|88.94|
72413434|NCT01764945|144335664|NON_INFERIORITY_OR_EQUIVALENCE|investigation of relative bioavailability (no formal testing).|Geometric Mean Ratio|96.37|STANDARD_DEVIATION|12.7|||TWO_SIDED|90.0|91.55|101.43|||ANOVA||the standard deviation is actually the geometric coefficient of variation.|"relative bioavailability comparison of 120 mg faldaprevir soft gelatine capsules compared with the equivalent dose of an oral solution.~(treatment G : treatment E)."||101.43|91.55|
72413435|NCT01764945|144335664|NON_INFERIORITY_OR_EQUIVALENCE|investigation of relative bioavailability (no formal testing).|Geometric Mean Ratio|94.44|STANDARD_DEVIATION|12.0|||TWO_SIDED|90.0|89.88|99.24|||ANOVA||the standard deviation is actually the geometric coefficient of variation.|"relative bioavailability comparison of 120 mg faldaprevir soft gelatine capsules compared with the equivalent dose of an oral solution.~(treatment H : treatment E)."||99.24|89.88|
72413436|NCT01764945|144335665|NON_INFERIORITY_OR_EQUIVALENCE|investigation of relative bioavailability (no formal testing).|Geometric Mean Ratio|74.07|STANDARD_DEVIATION|21.5|||TWO_SIDED|90.0|65.44|83.83|||ANOVA||the standard deviation is actually the geometric coefficient of variation.|"relative bioavailability comparison of 40 mg faldaprevir soft gelatine capsules compared with the equivalent dose of an oral solution.~(treatment B : treatment A)."||83.83|65.44|
72413437|NCT01764945|144335665|NON_INFERIORITY_OR_EQUIVALENCE|investigation of relative bioavailability (no formal testing).|Geometric Mean Ratio|73.23|STANDARD_DEVIATION|26.2|||TWO_SIDED|90.0|63.33|84.68|||ANOVA||the standard deviation is actually the geometric coefficient of variation.|"relative bioavailability comparison of 40 mg faldaprevir soft gelatine capsules compared with the equivalent dose of an oral solution.~(treatment C : treatment A)."||84.68|63.33|
72413438|NCT01764945|144335665|NON_INFERIORITY_OR_EQUIVALENCE|investigation of relative bioavailability (no formal testing).|Geometric Mean Ratio|78.76|STANDARD_DEVIATION|22.7|||TWO_SIDED|90.0|68.94|89.99|||ANOVA||the standard deviation is actually the geometric coefficient of variation.|"relative bioavailability comparison of 40 mg faldaprevir soft gelatine capsules compared with the equivalent dose of an oral solution.~(treatment D : treatment A)."||89.99|68.94|
72413439|NCT01764945|144335665|NON_INFERIORITY_OR_EQUIVALENCE|investigation of relative bioavailability (no formal testing).|Geometric Mean Ratio|78.3|STANDARD_DEVIATION|22.5|||TWO_SIDED|90.0|71.42|85.84|||ANOVA||the standard deviation is actually the geometric coefficient of variation.|"relative bioavailability comparison of 120 mg faldaprevir soft gelatine capsules compared with the equivalent dose of an oral solution.~(treatment F : treatment E)."||85.84|71.42|
72413440|NCT01764945|144335665|NON_INFERIORITY_OR_EQUIVALENCE|investigation of relative bioavailability (no formal testing).|Geometric Mean Ratio|78.43|STANDARD_DEVIATION|30.4|||TWO_SIDED|90.0|69.54|88.46|||ANOVA||the standard deviation is actually the geometric coefficient of variation.|"relative bioavailability comparison of 120 mg faldaprevir soft gelatine capsules compared with the equivalent dose of an oral solution.~(treatment G : treatment E)."||88.46|69.54|
72552162|NCT01390844|144634912|SUPERIORITY_OR_OTHER||Difference in Percentage|36.13||||0.004|TWO_SIDED|95.0|12.12|55.01|||Mittienen and Nurminen|||Between-Group Comparison||55.01|12.12|0.004
72552163|NCT05093205|144634931|OTHER|0.15 mg LE \& 0.03 mg EE was the Reference treatment (Part B Period 1), PF-06882961 120 mg BID + 0.15 mg LE \& 0.03 mg EE was the Test treatment (Period 3).|Specified in comments|122.48|||||TWO_SIDED|90.0|106.96|140.25|||Mixed Models Analysis||A mixed effects model with treatment as a fixed effect and participant as a random effect was used was applied to calculate the ratio (Test/Reference) of adjusted means and 90% CIs for Ratio. The ratio (and 90% CI) is expressed as percentage.|||140.25|106.96|
72413441|NCT01764945|144335665|NON_INFERIORITY_OR_EQUIVALENCE|investigation of relative bioavailability (no formal testing).|Geometric Mean Ratio|78.09|STANDARD_DEVIATION|29.4|||TWO_SIDED|90.0|69.35|87.94|||ANOVA||the standard deviation is actually the geometric coefficient of variation.|"relative bioavailability comparison of 120 mg faldaprevir soft gelatine capsules compared with the equivalent dose of an oral solution.~(treatment H : treatment E)."||87.94|69.35|
72413442|NCT01764945|144335666|NON_INFERIORITY_OR_EQUIVALENCE|investigation of relative bioavailability (no formal testing).|Geometric Mean Ratio|82.02|STANDARD_DEVIATION|13.1|||TWO_SIDED|90.0|75.98|88.55|||ANOVA||the standard deviation is actually the geometric coefficient of variation.|"relative bioavailability comparison of 40 mg faldaprevir soft gelatine capsules compared with the equivalent dose of an oral solution.~(treatment B : treatment A)."||88.55|75.98|
72584480|NCT00833105|144700373|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|||||No multiple comparison procedure performed|Wilcoxon Signed Rank Test|||||||<0.05
72413443|NCT01764945|144335666|NON_INFERIORITY_OR_EQUIVALENCE|investigation of relative bioavailability (no formal testing).|Geometric Mean Ratio|80.93|STANDARD_DEVIATION|14.5|||TWO_SIDED|90.0|74.58|87.83|||ANOVA||the standard deviation is actually the geometric coefficient of variation.|"relative bioavailability comparison of 40 mg faldaprevir soft gelatine capsules compared with the equivalent dose of an oral solution.~(treatment C : treatment A)."||87.83|74.58|
72413444|NCT01764945|144335666|NON_INFERIORITY_OR_EQUIVALENCE|investigation of relative bioavailability (no formal testing).|Geometric Mean Ratio|79.6|STANDARD_DEVIATION|10.2|||TWO_SIDED|90.0|74.84|84.67|||ANOVA||the standard deviation is actually the geometric coefficient of variation.|"relative bioavailability comparison of 40 mg faldaprevir soft gelatine capsules compared with the equivalent dose of an oral solution.~(treatment D : treatment A)."||84.67|74.84|
72584481|NCT00833105|144700374|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||No multiple comparison procedure|Wilcoxon Signed Rank Test|||||||<0.0001
72584482|NCT00833105|144700375|SUPERIORITY_OR_OTHER||||||<|0.005|TWO_SIDED|||||No multiple comparison adjustment.|Wilcoxon Signed Rank Test|||||||<0.005
72584483|NCT00833105|144700376|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||No multiple comparison adjustment.|Wilcoxon Signed Rank Test|||||||<0.001
72584484|NCT00833105|144700377|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||No multiple comparisons adjustment.|Wilcoxon Signed Rank Test|||||||<0.001
72584485|NCT00925704|144700438|SUPERIORITY_OR_OTHER_LEGACY|||||||0.171||95.0|||||Mixed Models Analysis|||Exogenous calcitriol was analyzed using a mixed linear effects model. This model contained sequence group, period, and treatment as fixed effects. The subject within sequence effect was included as a random effect.||||0.171
72413445|NCT01764945|144335666|NON_INFERIORITY_OR_EQUIVALENCE|investigation of relative bioavailability (no formal testing).|Geometric Mean Ratio|91.59|STANDARD_DEVIATION|11.0|||TWO_SIDED|90.0|87.53|95.84|||ANOVA||the standard deviation is actually the geometric coefficient of variation.|"relative bioavailability comparison of 120 mg faldaprevir soft gelatine capsules compared with the equivalent dose of an oral solution.~(treatment F : treatment E)."||95.84|87.53|
72413446|NCT01764945|144335666|NON_INFERIORITY_OR_EQUIVALENCE|investigation of relative bioavailability (no formal testing).|Geometric Mean Ratio|94.38|STANDARD_DEVIATION|12.4|||TWO_SIDED|90.0|89.76|99.24|||ANOVA||the standard deviation is actually the geometric coefficient of variation.|"relative bioavailability comparison of 120 mg faldaprevir soft gelatine capsules compared with the equivalent dose of an oral solution.~(treatment G : treatment E)."||99.24|89.76|
72413447|NCT01764945|144335666|NON_INFERIORITY_OR_EQUIVALENCE|investigation of relative bioavailability (no formal testing).|Geometric Mean Ratio|92.91|STANDARD_DEVIATION|12.0|||TWO_SIDED|90.0|88.42|97.63|||ANOVA||the standard deviation is actually the geometric coefficient of variation.|"relative bioavailability comparison of 120 mg faldaprevir soft gelatine capsules compared with the equivalent dose of an oral solution.~(treatment H : treatment E)."||97.63|88.42|
72413448|NCT02911948|144335670|SUPERIORITY|Superiority was considered confirmed if the upper bound of the two-sided 95% confidence interval was strictly below 0.0% for null hypothesis (H0): D=0.0% against the alternative (HA): D≠0.0%, where D is the mean difference (IDegLira - IDeg).|Treatment contrast|-1.28|||<|0.0001|TWO_SIDED|95.0|-1.5|-1.06|||ANCOVA|||The response and change from baseline in response after 26 weeks are analysed using an ANCOVA model with treatment and pre-trial anti-diabetic treatment as fixed factors and corresponding baseline HbA1c value as covariate.||-1.06|-1.50|<0.0001
72413449|NCT02877485|144335702|OTHER||Mean Difference (Net)|1.5||||0.7|TWO_SIDED|95.0|-6.0|8.9||"Statistical Tests:~Independent t-test to assess differences in mean change in NOSE scores when comparing the two study groups, and p\<0.05 deemed statistically significant"|t-test, 2 sided||Change in Mean NOSE score from baseline to post saline versus change in NOSE score from baseline to post intranasal steroid.|"1\) H0: mean change in NOSE score from baseline after in study group 1 = mean change in NOSE score from baseline in study group 2~Power calculation: To detect a 20% difference in NOSE scores with 80% power and a 2-sided alpha level of 0.05 required 20 participants per study group, for a total of 40 participants."||8.9|-6.0|0.7
72413450|NCT02877485|144335703|OTHER||Mean Difference (Final Values)|-50.0|STANDARD_DEVIATION|27.6|<|0.001|TWO_SIDED|||||Paired t-tests to assess differences in mean NOSE score when the treatment groups were combined (saline arm+ steroid arm) at five post-operative time intervals compared to the combined preoperative baseline scores. Significance at p\<0.05.|Paired t-test|||H0: Mean pre- treatment baseline patient NOSE score = Mean post- treatment baseline patient NOSE score.||||<0.001
72413451|NCT03762135|144335742|SUPERIORITY|||||||0.044||||||This relates to the entirety of the 6-week period.|GEE Linear Regression|Generalized Estimation Equation Linear Regression||||||0.044
72413452|NCT02276482|144335747|OTHER||Difference in percentages|3.6|||||TWO_SIDED|95.0|-6.3|13.5|||||The difference (Tedizolid minus Comparator group) in the clinical success rate and 95% confidence interval calculated using the unstratified method of Miettinen and Nurminen.|||13.5|-6.3|
72413453|NCT02276482|144335748|OTHER||Difference in percentages|3.7|||||TWO_SIDED|95.0|-3.4|10.8|||||The difference (Tedizolid minus Comparator group) in the clinical success rate and 95% confidence interval calculated using the unstratified method of Miettinen and Nurminen.|||10.8|-3.4|
72413454|NCT02276482|144335749|OTHER||Difference in percentages|-4.2|||||TWO_SIDED|95.0|-12.9|4.4|||||The difference (Tedizolid minus Comparator group) in the clinical success rate and 95% confidence interval calculated using the unstratified method of Miettinen and Nurminen.|||4.4|-12.9|
72413455|NCT02276482|144335750|OTHER||Difference in percentages|0.2|||||TWO_SIDED|95.0|-7.4|7.7|||||The difference (Tedizolid minus Comparator group) in the clinical success rate and 95% confidence interval calculated using the unstratified method of Miettinen and Nurminen.|||7.7|-7.4|
72552164|NCT05093205|144634931|OTHER|0.15 mg LE \& 0.03 mg EE was the Reference treatment (Part B Period 1), PF-06882961 200 mg BID + 0.15 mg LE \& 0.03 mg EE was the Test treatment (Period 5).|Specified in comments|143.83|||||TWO_SIDED|90.0|122.64|168.68|||Mixed Models Analysis||A mixed effects model with treatment as a fixed effect and participant as a random effect was used was applied to calculate the ratio (Test/Reference) of adjusted means and 90% CIs for Ratio. The ratio (and 90% CI) is expressed as percentage.|||168.68|122.64|
72552165|NCT05093205|144634932|OTHER|0.15 mg LE \& 0.03 mg EE was the Reference treatment (Part B Period 1), PF-06882961 120 mg BID + 0.15 mg LE \& 0.03 mg EE was the Test treatment (Period 3).|Specified in comments|104.46|||||TWO_SIDED|90.0|92.56|117.89|||Mixed Models Analysis||A mixed effects model with treatment as a fixed effect and participant as a random effect was used was applied to calculate the ratio (Test/Reference) of adjusted means and 90% CIs for Ratio. The ratio (and 90% CI) is expressed as percentage.|||117.89|92.56|
72413456|NCT02276482|144335751|OTHER||Difference in percentages|0.0|||||TWO_SIDED|95.0|0.0|0.0|||||The difference (Tedizolid minus Comparator group) in the clinical success rate and 95% confidence interval calculated using the unstratified method of Miettinen and Nurminen.|||0.0|0.0|
72421547|NCT01181726|144354230|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|99.01|||||TWO_SIDED|90.0|94.17|104.11|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||104.11|94.17|
72413457|NCT01165281|144335760|NON_INFERIORITY_OR_EQUIVALENCE|In order to demonstrate that the upper limit of the confidence interval of intergroup differences in change from baseline is not higher than the noninferiority margin of 1 with a 1-tailed significance level of 0.025 and 90% power, the sample size was calculated to be 133 patients in each group for a total of 266 patients. Assuming approximately 20% of patients would be excluded from the analyses, the target sample size was 330 patients.|Least-Squares Mean Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.226||0.786|TWO_SIDED|95.0|-0.506|0.383|||ANCOVA|Analysis of covariance (ANCOVA) model was used with treatment and country as factors and baseline pain intensity score as a covariate.||The primary hypothesis to be tested for the study was that the JNS024 ER group was not inferior to oxycodone CR as defined by the upper limit of the 95% confidence interval of the difference between JNS024 ER and oxycodone CR on the mean change from baseline of the NRS pain intensity score during the last 3 days of study drug administration. It was to be concluded that JNS024 ER is not inferior to oxycodone CR if the upper 95% confidence limit is less than 1 point.||0.383|-0.506|0.786
72413458|NCT00364858|144335775|SUPERIORITY_OR_OTHER||Agresti and Min|-0.176||||||95.0|-0.357|0.058||||||Difference in proportion of Clinical Success = (Proportion of participants with Clinical Success Q4 - Proportion of participants with Clinical Success Q2).||0.058|-0.357|
72413459|NCT02005471|144335780|SUPERIORITY||Hazard Ratio (HR)|0.23|||<|0.0001|TWO_SIDED|95.0|0.18|0.29|||Log Rank||Hazard ratio was estimated by Cox regression model.|Stratified analysis: 17p deletion, risk status, geographic region.||0.29|0.18|<.0001
72413460|NCT02005471|144335780|SUPERIORITY||Hazard Ratio (HR)|0.25|||<|0.0001|TWO_SIDED|95.0|0.19|0.31|||Log Rank||Hazard ratio was estimated by Cox regression model|Unstratified Analysis||0.31|0.19|<.0001
72413461|NCT02005471|144335782|SUPERIORITY||Hazard Ratio (HR)|0.19|||<|0.0001|TWO_SIDED|95.0|0.13|0.28|||Log Rank||Hazard ratio was estimated by Cox regression model.|Stratified Analysis; Stratification factors: 17p deletion, risk status, geographic region.||0.28|0.13|<.0001
72413462|NCT02005471|144335782|SUPERIORITY||Hazard Ratio (HR)|0.2|||<|0.0001|TWO_SIDED|95.0|0.14|0.3|||Log Rank||Hazard ratio was estimated by Cox regression model.|Unstratified Analysis||0.30|0.14|<.0001
72413463|NCT02005471|144335784|SUPERIORITY||Hazard Ratio (HR)|0.35|||<|0.0001|TWO_SIDED|95.0|0.21|0.57|||Log Rank||Hazard ratio was estimated by Cox regression model.|Stratified Analysis; Stratification factor: geographic region.||0.57|0.21|<.0001
72413464|NCT02005471|144335784|SUPERIORITY||Hazard Ratio (HR)|0.35|||<|0.0001|TWO_SIDED|95.0|0.22|0.56|||Log Rank||Hazard ratio was estimated by Cox regression model.|Unstratified Analysis||0.56|0.22|<.0001
72413465|NCT02005471|144335786|SUPERIORITY||Hazard Ratio (HR)|0.21|||<|0.0001|TWO_SIDED|95.0|0.09|0.49|||Log Rank||Hazard ratio was estimated by Cox regression model.|Stratified Analysis; Stratification factor: geographic region.||0.49|0.09|<.0001
72413466|NCT02005471|144335786|SUPERIORITY||Hazard Ratio (HR)|0.21|||<|0.0001|TWO_SIDED|95.0|0.09|0.46|||Log Rank||Hazard ratio was estimated by Cox regression model.|Unstratified Analysis||0.46|0.09|<.0001
72552166|NCT05093205|144634932|OTHER|0.15 mg LE \& 0.03 mg EE was the Reference treatment (Part B Period 1), PF-06882961 200 mg BID + 0.15 mg LE \& 0.03 mg EE was the Test treatment (Period 5).|Specified in comments|92.77|||||TWO_SIDED|90.0|81.05|106.19|||Mixed Models Analysis||A mixed effects model with treatment as a fixed effect and participant as a random effect was used was applied to calculate the ratio (Test/Reference) of adjusted means and 90% CIs for Ratio. The ratio (and 90% CI) is expressed as percentage.|||106.19|81.05|
72584486|NCT00925704|144700438|SUPERIORITY_OR_OTHER_LEGACY|||||||0.024||95.0|||||Mixed Models Analysis|||Exogenous calcitriol was analyzed using a mixed linear effects model. This model contained sequence group, period, and treatment as fixed effects. The subject within sequence effect was included as a random effect.||||0.024
72584487|NCT00925704|144700439|SUPERIORITY_OR_OTHER_LEGACY|||||||0.313||95.0|||||Mixed Models Analysis|||Exogenous calcitriol was analyzed using a mixed linear effects model. This model contained sequence group, period, and treatment as fixed effects. The subject within sequence effect was included as a random effect.||||0.313
72413467|NCT02005471|144335787|SUPERIORITY||Difference in Response Rates|25.61|||<|0.0001|TWO_SIDED|95.0|17.88|33.33|||Cochran-Mantel-Haenszel||95% CI for rates were constructed using Pearson- Clopper method. 95% CI for difference in rates were constructed using Anderson-Hauck method.|||33.33|17.88|<.0001
72413468|NCT02005471|144335787|SUPERIORITY||Odds Ratio (OR)|7.81|||||TWO_SIDED|95.0|3.97|15.37|||||OR was estimated using logistic regression model. The 95% CI was computed using Wald test.|||15.37|3.97|
72552167|NCT03693430|144634959|SUPERIORITY|Week 104 responses were analysed using an analysis of covariance model with randomised treatment as factor and baseline body weight as covariate. Missing observations were multiple (x1000) imputed from retrieved subjects of the same randomised treatment arm.|Treatment difference|-12.55|||<|0.0001|TWO_SIDED|95.0|-15.33|-9.77|||ANCOVA|||Treatment policy estimand||-9.77|-15.33|<.0001
72552168|NCT03693430|144634959|SUPERIORITY|All responses prior to first discontinuation of treatment (or initiation of other anti-obesity medication or bariatric surgery) were included in a mixed model for repeated measurements with randomised treatment as factor and baseline body weight as covariate, all nested within visit.|Treatment difference|-16.05|||<|0.0001|TWO_SIDED|95.0|-18.64|-13.45|||MMRM (Mixed model repeated measurement)|||Hypothetical estimand||-13.45|-18.64|<0.0001
72552169|NCT03693430|144634960|SUPERIORITY||Odds Ratio (OR)|4.99|||<|0.0001|TWO_SIDED|95.0|2.95|8.42|||Regression, Logistic|||Treatment policy estimand||8.42|2.95|<0.0001
72552170|NCT03693430|144634960|SUPERIORITY||Odds Ratio (OR)|18.06|||<|0.0001|TWO_SIDED|95.0|10.04|32.49|||MMRM|||Hypothetical estimand||32.49|10.04|<0.0001
72552171|NCT04185909|144634996|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||||||<.0001
72552172|NCT00048581|144635014|SUPERIORITY_OR_OTHER||Est. Weighted. Diff: Day 169 ACR 20|30.8|||<|0.001|TWO_SIDED|95.0|20.6|41.1||The a priori threshold for statistical significance was 5%. ACR 20 RR at 6 mos for PLA was expected to be \~25%. A sample of 256 in the ABA arm and 128 in PLA arm will yield a 96% power to detect a difference of 20% in ACR 20 at 5% significance level.|Cochran-Mantel-Haenszel|All statistical tests and CI were 2-sided. Percentage of participants with response compared by estimate of weighted difference (Est of Weighted Diff)|Differences in ACR response between the two treatment groups represent the weighted average of the individual stratum differences.|The first coprimary endpoint efficacy analysis tested for differences in ACR 20 response rate (RR) between the treatment arm receiving ABA plus background DMARDs and the treatment arm receiving placebo plus background DMARDs on Day 169. A 2-sided Cochran-Mantel-Haenszel (CMH) Chi-square test was used to compare these two treatment groups at the .05 level of significance, with stratification based on baseline history of anti-TNF status (current or prior use).||41.1|20.6|<0.001
72552173|NCT00048581|144635015|SUPERIORITY_OR_OTHER||Est. of Weighted Diff: Day 169 HAQ|24.0|||<|0.001|TWO_SIDED|95.0|13.8|34.2||If the ACR20 analysis was not significant (5% level), then the comparison for HAQ response was not undertaken. If ACR20 comparison was significant (5% level), then CMH Chi-square test compared HAQ response between groups (5% level).|Cochran-Mantel-Haenszel|All statistical tests and CI were 2-sided. Percentage of participants with response compared by estimate of weighted difference (Est of Weighted Diff)|All comparisons of changes from baseline and construction of confidence intervals for continuous measures were based on an ANCOVA model with treatment as the main factor and baseline value as covariate.|The two primary efficacy analyses tested first for differences in ACR 20 followed by testing HAQ response rates between the treatment arm receiving ABA plus background DMARDs and the treatment arm receiving PLA plus background DMARDs on Day 169. A 2-sided Cochran-Mantel-Haenszel (CMH) Chi-square test was used to compare these two treatment groups at the .05 level of significance, with stratification based on baseline history of anti-TNF status (current or prior use).||34.2|13.8|<0.001
72552174|NCT00048581|144635016|SUPERIORITY_OR_OTHER||Est. of Diff: Day 15 ACR 20|12.3||||0.001|TWO_SIDED|95.0|4.6|20.0|||Cochran-Mantel-Haenszel|All statistical tests and CI were 2-sided. Percentage of participants with response compared by estimate of difference (Est of Diff)||Differences in ACR 20 between the treatment arm receiving ABA plus background DMARDs and the treatment arm receiving PLA plus background DMARDs were compared using a 2-sided Cochran-Mantel-Haenszel (CMH) Chi-square test (.05 level of significance), with stratification based on baseline history of anti-TNF status (current or prior use).||20.0|4.6|0.001
72584488|NCT00925704|144700439|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||Mixed Models Analysis|||Exogenous calcitriol was analyzed using a mixed linear effects model. This model contained sequence group, period, and treatment as fixed effects. The subject within sequence effect was included as a random effect.||||< 0.001
72584489|NCT00925704|144700440|SUPERIORITY_OR_OTHER_LEGACY|||||||0.039||95.0|||||Wilcoxon (Hodges-Lehmann)|||Analysis for Tmax used the Hodges-Lehmann estimate for Wilcoxon's Signed Rank Test.||||0.039
72584490|NCT00925704|144700440|SUPERIORITY_OR_OTHER_LEGACY|||||||0.305||95.0|||||Wilcoxon (Hodges-Lehmann)|||Analysis for Tmax used the Hodges-Lehmann estimate for Wilcoxon's Signed Rank Test.||||0.305
72584491|NCT00216125|144700441|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|10.0||||0.883|TWO_SIDED|95.0|||||Log Rank|||||||0.883
72413469|NCT02005471|144335788|SUPERIORITY||Difference in Response Rates|25.61|||<|0.0001|TWO_SIDED|95.0|17.88|33.33|||Cochran-Mantel-Haenszel||95% CI for rates were constructed using Pearson- Clopper method. 95% CI for difference in rates were constructed using Anderson-Hauck method.|||33.33|17.88|<.0001
72584492|NCT01671007|144700446|OTHER||Hazard Ratio (HR)|0.83|||||TWO_SIDED|95.0|0.64|1.08|||Regression, Cox||Hazard ratio of dabigatran versus vitamin K antagonist (vitamin K antagonist as reference).|A multivariable Cox regression model was performed including variables of treatment, age, gender, prior bleed, previous stroke/transient ischaemic attack/systemic embolism, previous myocardial infarction, abnormal kidney function and concomitant antiplatelets use.||1.08|0.64|
72584493|NCT01671007|144700447|OTHER||Hazard Ratio (HR)|0.94|||||TWO_SIDED|95.0|0.7|1.27|||Regression, Cox||Hazard ratio of dabigatran versus vitamin K antagonist (vitamin K antagonist as reference).|A multivariable Cox regression model was performed including variables of treatment, age, gender, prior bleed, previous stroke/transient ischaemic attack/systemic embolism, previous myocardial infarction, abnormal kidney function and concomitant antiplatelets use.||1.27|0.70|
72584494|NCT01671007|144700448|OTHER||Hazard Ratio (HR)|0.67|||||TWO_SIDED|95.0|0.43|1.06|||Regression, Cox||Hazard ratio of dabigatran versus vitamin K antagonist (vitamin K antagonist as reference).|A multivariable Cox regression model was performed including variables of treatment, age, gender, prior bleed, previous stroke/transient ischaemic attack/systemic embolism, previous myocardial infarction, abnormal kidney function and concomitant antiplatelets use.||1.06|0.43|
72584495|NCT01671007|144700449|OTHER||Hazard Ratio (HR)|0.68|||||TWO_SIDED|95.0|0.43|1.09|||Regression, Cox||Hazard ratio of dabigatran versus vitamin K antagonist (vitamin K antagonist as reference).|A multivariable Cox regression model was performed including variables of treatment, age, gender, prior bleed, previous stroke/transient ischaemic attack/systemic embolism, previous myocardial infarction, abnormal kidney function and concomitant antiplatelets use.||1.09|0.43|
72413470|NCT02005471|144335788|SUPERIORITY||Odds Ratio (OR)|7.81|||||TWO_SIDED|95.0|3.97|15.37|||||OR was estimated using logistic regression model. The 95% CI was computed using Wald test.|||15.37|3.97|
72413471|NCT02005471|144335789|SUPERIORITY||Difference in Response Rates|25.07|||<|0.0001|TWO_SIDED|95.0|16.63|33.51|||Cochran-Mantel-Haenszel||The 95% CI was computed using Anderson-Hauck method.|||33.51|16.63|<.0001
72413472|NCT02005471|144335789|SUPERIORITY||Odds Ratio (OR)|4.59|||||TWO_SIDED|95.0|2.68|7.88|||||OR was estimated using logistic regression model. The 95% CI was computed using Wald test.|||7.88|2.68|
72584496|NCT01671007|144700453|OTHER||Hazard Ratio (HR)|0.58|||||TWO_SIDED|95.0|0.38|0.88|||Regression, Cox||Hazard ratio of dabigatran versus vitamin K antagonist (vitamin K antagonist as reference).|A multivariable Cox regression model was performed including variables of treatment, age, gender, prior bleed, previous myocardial infarction, abnormal kidney function, concomitant antiplatelets use and concomitant use of drugs related to bleeding.||0.88|0.38|
72584497|NCT01671007|144700456|OTHER||Hazard Ratio (HR)|0.95|||||TWO_SIDED|95.0|0.49|1.84|||Regression, Cox||Hazard ratio of dabigatran versus vitamin K antagonist (vitamin K antagonist as reference).|A multivariable Cox regression model was performed including variables of treatment, age, gender, prior bleed, previous myocardial infarction, concomitant antiplatelets use, concomitant use of drugs related to bleeding, hypertension, and diabetes.||1.84|0.49|
72584498|NCT01671007|144700457|OTHER||Hazard Ratio (HR)|0.78|||||TWO_SIDED|95.0|0.6|1.01|||Regression, Cox||Hazard ratio of dabigatran versus vitamin K antagonist (vitamin K antagonist as reference).|A multivariable Cox regression model was performed including variables of treatment, age, gender, prior bleed, previous stroke/transient ischaemic attack/systemic embolism, previous myocardial infarction, abnormal kidney function and concomitant antiplatelets use.||1.01|0.60|
72584499|NCT04630002|144700465|OTHER||Ratio of geometric least square means|1.137|||||TWO_SIDED|90.0|0.999|1.293|||||A linear mixed-effects model with period as a fixed effect, participant as a random effect, and measurements within participant as repeated measures was performed on the log-transformed parameter AUC(0-tau).|||1.293|0.9990|
72584500|NCT04630002|144700466|OTHER||Ratio of geometric least square means|1.068|||||TWO_SIDED|90.0|0.9185|1.242|||||A linear mixed-effects model with period as a fixed effect, participant as a random effect, and measurements within participant as repeated measures was performed on the log-transformed parameter Cmax.|||1.242|0.9185|
72584501|NCT04630002|144700467|OTHER||Ratio of geometric least square means|0.9891|||||TWO_SIDED|90.0|0.9313|1.051|||||A linear mixed-effects model with period as a fixed effect, participant as a random effect, and measurements within participant as repeated measures was performed on the log-transformed parameter AUC(0-tau).|||1.051|0.9313|
72584502|NCT04630002|144700468|OTHER||Ratio of geometric least square means|1.05|||||TWO_SIDED|90.0|0.9816|1.122|||||A linear mixed-effects model with period as a fixed effect, participant as a random effect, and measurements within participant as repeated measures was performed on the log-transformed parameter Cmax.|||1.122|0.9816|
72584503|NCT04630002|144700469|OTHER||Ratio of geometric least square means|1.102|||||TWO_SIDED|90.0|1.025|1.185|||||A linear mixed-effects model with period as a fixed effect, participant as a random effect, and measurements within participant as repeated measures was performed on the log-transformed parameter AUC(0-tau).|||1.185|1.025|
72584504|NCT04630002|144700470|OTHER||Ratio of geometric least square means|1.12|||||TWO_SIDED|90.0|0.9947|1.26|||||A linear mixed-effects model with period as a fixed effect, participant as a random effect, and measurements within participant as repeated measures was performed on the log-transformed parameter Cmax.|||1.260|0.9947|
72584505|NCT04630002|144700471|OTHER||Ratio of geometric least square means|0.5299|||||TWO_SIDED|90.0|0.4801|0.5848|||||A linear mixed-effects model with period as a fixed effect, participant as a random effect, and measurements within participant as repeated measures was performed on the log-transformed parameter AUC(0-tau).|||0.5848|0.4801|
72584506|NCT04630002|144700472|OTHER||Ratio of geometric least square means|0.6001|||||TWO_SIDED|90.0|0.5271|0.6833|||||A linear mixed-effects model with period as a fixed effect, participant as a random effect, and measurements within participant as repeated measures was performed on the log-transformed parameter Cmax.|||0.6833|0.5271|
72584507|NCT04630002|144700473|OTHER||Ratio of geometric least square means|1.144|||||TWO_SIDED|90.0|1.082|1.21|||||A linear mixed-effects model with period as a fixed effect, participant as a random effect, and measurements within participant as repeated measures was performed on the log-transformed parameter AUC(0-tau).|||1.210|1.082|
72584508|NCT04630002|144700474|OTHER||Ratio of geometric least square means|1.104|||||TWO_SIDED|90.0|1.026|1.187|||||A linear mixed-effects model with period as a fixed effect, participant as a random effect, and measurements within participant as repeated measures was performed on the log-transformed parameter Cmax.|||1.187|1.026|
72413473|NCT02005471|144335790|SUPERIORITY||Difference in Response Rates|24.55|||<|0.0001|TWO_SIDED|95.0|16.0|33.1|||Cochran-Mantel-Haenszel||The 95% CI was computed using Anderson-Hauck method.|||33.10|16.00|<.0001
72584509|NCT04630002|144700475|OTHER||Ratio of geometric least square means|0.9435|||||TWO_SIDED|90.0|0.8147|1.093|||||A linear mixed-effects model with period as a fixed effect, participant as a random effect, and measurements within participant as repeated measures was performed on the log-transformed parameter AUC(0-tau).|||1.093|0.8147|
72584510|NCT04630002|144700476|OTHER||Ratio of geometric least square means|0.8928|||||TWO_SIDED|90.0|0.7467|1.068|||||A linear mixed-effects model with period as a fixed effect, participant as a random effect, and measurements within participant as repeated measures was performed on the log-transformed parameter Cmax.|||1.068|0.7467|
72584511|NCT04498182|144700514|SUPERIORITY||LS Mean Difference|-3.4|STANDARD_ERROR_OF_MEAN|2.81||0.2305|TWO_SIDED|95.0|-8.9|2.2|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||2.2|-8.9|0.2305
72584512|NCT04498182|144700514|SUPERIORITY||LS Mean Difference|0.9|STANDARD_ERROR_OF_MEAN|2.81||0.7436|TWO_SIDED|95.0|-4.6|6.4|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||6.4|-4.6|0.7436
72584513|NCT04498182|144700515|SUPERIORITY||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.7||0.4936|TWO_SIDED|95.0|-1.9|0.9|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||0.9|-1.9|0.4936
72584514|NCT04498182|144700515|SUPERIORITY||LS Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|0.7||0.7131|TWO_SIDED|95.0|-1.1|1.6|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||1.6|-1.1|0.7131
72584515|NCT04498182|144700516|SUPERIORITY||LS Mean Difference|-3.4|STANDARD_ERROR_OF_MEAN|2.81||0.2305|TWO_SIDED|95.0|-8.9|2.2|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||2.2|-8.9|0.2305
72584516|NCT04498182|144700516|SUPERIORITY||LS Mean Difference|0.9|STANDARD_ERROR_OF_MEAN|2.81||0.7436|TWO_SIDED|95.0|-4.6|6.4|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||6.4|-4.6|0.7436
72584517|NCT04498182|144700517|SUPERIORITY||LS Mean Difference|-7.0|STANDARD_ERROR_OF_MEAN|3.17||0.0281|TWO_SIDED|95.0|-13.2|-0.8|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||-0.8|-13.2|0.0281
72584518|NCT04498182|144700517|SUPERIORITY||LS Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|3.18||0.9186|TWO_SIDED|95.0|-5.9|6.6|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||6.6|-5.9|0.9186
72584519|NCT04498182|144700518|SUPERIORITY||LS Mean Difference|-7.0|STANDARD_ERROR_OF_MEAN|3.17||0.0281|TWO_SIDED|95.0|-13.2|-0.8|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||-0.8|-13.2|0.0281
72584520|NCT04498182|144700518|SUPERIORITY||LS Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|3.18||0.9186|TWO_SIDED|95.0|-5.9|6.6|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||6.6|-5.9|0.9186
72584521|NCT04498182|144700519|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.75||0.9846|TWO_SIDED|95.0|-1.5|1.5|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||1.5|-1.5|0.9846
72584522|NCT04498182|144700519|SUPERIORITY||LS Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|0.75||0.6508|TWO_SIDED|95.0|-1.1|1.8|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||1.8|-1.1|0.6508
72584523|NCT04498182|144700520|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.75||0.9846|TWO_SIDED|95.0|-1.5|1.5|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||1.5|-1.5|0.9846
72584524|NCT04498182|144700520|SUPERIORITY||LS Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|0.75||0.6508|TWO_SIDED|95.0|-1.1|1.8|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||1.8|-1.1|0.6508
72584525|NCT04498182|144700521|SUPERIORITY||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.7||0.4936|TWO_SIDED|95.0|-1.9|0.9|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||0.9|-1.9|0.4936
72584526|NCT04498182|144700521|SUPERIORITY||LS Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|0.7||0.7131|TWO_SIDED|95.0|-1.1|1.6|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||1.6|-1.1|0.7131
72584527|NCT04498182|144700522|SUPERIORITY||LS Mean Difference|-6.0|STANDARD_ERROR_OF_MEAN|3.38||0.0786|TWO_SIDED|95.0|-12.6|0.7|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||0.7|-12.6|0.0786
72584528|NCT04498182|144700522|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|3.39||0.9477|TWO_SIDED|95.0|-6.9|6.5|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||6.5|-6.9|0.9477
72584529|NCT04498182|144700523|SUPERIORITY||LS Mean Difference|-6.0|STANDARD_ERROR_OF_MEAN|3.38||0.0786|TWO_SIDED|95.0|-12.6|0.7|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||0.7|-12.6|0.0786
72584530|NCT04498182|144700523|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|3.39||0.9477|TWO_SIDED|95.0|-6.9|6.5|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||6.5|-6.9|0.9477
72584531|NCT04498182|144700524|SUPERIORITY||LS Means Difference|-5.0|STANDARD_ERROR_OF_MEAN|3.16||0.1153|TWO_SIDED|95.0|-11.2|1.2|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||1.2|-11.2|0.1153
72584532|NCT04498182|144700524|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|3.15||0.9975|TWO_SIDED|95.0|-6.2|6.2|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||6.2|-6.2|0.9975
72584533|NCT04498182|144700525|SUPERIORITY||LS Mean Difference|-5.0|STANDARD_ERROR_OF_MEAN|3.16||0.1153|TWO_SIDED|95.0|-11.2|1.2|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||1.2|-11.2|0.1153
72584534|NCT04498182|144700525|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|3.15||0.9975|TWO_SIDED|95.0|-6.2|6.2|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||6.2|-6.2|0.9975
72413474|NCT02005471|144335790|SUPERIORITY||Odds Ratio (OR)|4.59|||||TWO_SIDED|95.0|2.68|7.85|||||OR was estimated using logistic regression model. The 95% CI was computed using Wald test.|||7.85|2.68|
72584535|NCT04498182|144700526|SUPERIORITY||LS Mean Difference|-5.5|STANDARD_ERROR_OF_MEAN|3.82||0.1518|TWO_SIDED|95.0|-13.0|2.0|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||2.0|-13.0|0.1518
72584536|NCT04498182|144700526|SUPERIORITY||LS Mean Difference|3.2|STANDARD_ERROR_OF_MEAN|3.87||0.407|TWO_SIDED|95.0|-4.4|10.8|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||10.8|-4.4|0.4070
72584537|NCT04498182|144700527|SUPERIORITY||LS Mean Difference|-5.5|STANDARD_ERROR_OF_MEAN|3.82||0.1518|TWO_SIDED|95.0|-13.0|2.0|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||2.0|-13.0|0.1518
72413475|NCT02005471|144335792|SUPERIORITY|Stratified Analysis; Stratification factors: 17p deletion, risk status, geographic region.|Hazard Ratio (HR)|0.53||||0.0002|TWO_SIDED|95.0|0.37|0.74|||Log Rank||Hazard ratio was estimated by Cox regression model.|||0.74|0.37|0.0002
72413476|NCT02005471|144335792|SUPERIORITY||Hazard Ratio (HR)|0.54||||0.0003|TWO_SIDED|95.0|0.39|0.76|||Log Rank||Hazard ratio was estimated by Cox regression model.|Unstratified Analysis||0.76|0.39|0.0003
72584538|NCT04498182|144700527|SUPERIORITY||LS Mean Difference|3.2|STANDARD_ERROR_OF_MEAN|3.87||0.407|TWO_SIDED|95.0|-4.4|10.8|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||10.8|-4.4|0.4070
72584539|NCT04498182|144700528|SUPERIORITY||LS Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|3.56||0.756|TWO_SIDED|95.0|-8.1|5.9|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||5.9|-8.1|0.7560
72584540|NCT04498182|144700528|SUPERIORITY||LS Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|3.62||0.8308|TWO_SIDED|95.0|-7.9|6.4|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||6.4|-7.9|0.8308
72584541|NCT04498182|144700529|SUPERIORITY||LS Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|3.56||0.756|TWO_SIDED|95.0|-8.1|5.9|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||5.9|-8.1|0.7560
72584542|NCT04498182|144700529|SUPERIORITY||LS Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|3.62||0.8308|TWO_SIDED|95.0|-7.9|6.4|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||6.4|-7.9|0.8308
72584543|NCT04498182|144700530|SUPERIORITY||LS Mean Difference|-7.9|STANDARD_ERROR_OF_MEAN|2.26||0.0005|TWO_SIDED|95.0|-12.4|-3.5|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||-3.5|-12.4|0.0005
72584544|NCT04498182|144700530|SUPERIORITY||LS Mean Difference|-4.3|STANDARD_ERROR_OF_MEAN|2.26||0.0585|TWO_SIDED|95.0|-8.7|0.2|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||0.2|-8.7|0.0585
72584545|NCT04498182|144700531|SUPERIORITY||LS Mean Difference|-7.9|STANDARD_ERROR_OF_MEAN|2.26||0.0005|TWO_SIDED|95.0|-12.4|-3.5|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||-3.5|-12.4|0.0005
72584546|NCT04498182|144700531|SUPERIORITY||LS Mean Difference|-4.3|STANDARD_ERROR_OF_MEAN|2.26||0.0585|TWO_SIDED|95.0|-8.7|0.2|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||0.2|-8.7|0.0585
72584547|NCT04498182|144700532|SUPERIORITY||LS Mean Difference|-8.9|STANDARD_ERROR_OF_MEAN|2.77||0.0015|TWO_SIDED|95.0|-14.3|-3.4|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||-3.4|-14.3|0.0015
72584548|NCT04498182|144700532|SUPERIORITY||LS Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|2.78||0.6812|TWO_SIDED|95.0|-6.6|4.3|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||4.3|-6.6|0.6812
72584549|NCT04498182|144700533|SUPERIORITY||LS Mean Difference|-8.9|STANDARD_ERROR_OF_MEAN|2.77||0.0015|TWO_SIDED|95.0|-14.3|-3.4|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||-3.4|-14.3|0.0015
72584550|NCT04498182|144700533|SUPERIORITY||LS Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|2.78||0.6812|TWO_SIDED|95.0|-6.6|4.3|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||4.3|-6.6|0.6812
72584551|NCT04498182|144700534|SUPERIORITY||LS Mean Difference|-3.6|STANDARD_ERROR_OF_MEAN|2.5||0.152|TWO_SIDED|95.0|-8.5|1.3|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||1.3|-8.5|0.1520
72584552|NCT04498182|144700534|SUPERIORITY||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|2.49||0.8515|TWO_SIDED|95.0|-5.4|4.4|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||4.4|-5.4|0.8515
72584553|NCT04498182|144700535|SUPERIORITY||LS Mean Difference|-3.6|STANDARD_ERROR_OF_MEAN|2.5||0.152|TWO_SIDED|95.0|-8.5|1.3|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||1.3|-8.5|0.1520
72584554|NCT04498182|144700535|SUPERIORITY||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|2.49||0.8515|TWO_SIDED|95.0|-5.4|4.4|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||4.4|-5.4|0.8515
72584555|NCT04498182|144700536|SUPERIORITY||LS Mean Difference|-6.3|STANDARD_ERROR_OF_MEAN|2.91||0.0302|TWO_SIDED|95.0|-12.1|-0.6|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||-0.6|-12.1|0.0302
72584556|NCT04498182|144700536|SUPERIORITY||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|2.92||0.8013|TWO_SIDED|95.0|-6.5|5.0|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||5.0|-6.5|0.8013
72584557|NCT04498182|144700537|SUPERIORITY||LS Mean Difference|-6.3|STANDARD_ERROR_OF_MEAN|2.91||0.0302|TWO_SIDED|95.0|-12.1|-0.6|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||-0.6|-12.1|0.0302
72413477|NCT02005471|144335794|SUPERIORITY||Hazard Ratio (HR)|0.22|||<|0.0001|TWO_SIDED|95.0|0.17|0.29|||Log Rank||Hazard ratio was estimated by Cox regression model.|Stratified Analysis; Stratification factors: 17p deletion, risk status, geographic region.||0.29|0.17|<.0001
72413478|NCT02005471|144335794|SUPERIORITY||Hazard Ratio (HR)|0.25|||<|0.0001|TWO_SIDED|95.0|0.19|0.31|||Log Rank||Hazard ratio was estimated by Cox regression model.|Unstratified Analysis||0.31|0.19|<.0001
72413479|NCT02005471|144335798|SUPERIORITY||Hazard Ratio (HR)|0.3|||<|0.0001|TWO_SIDED|95.0|0.23|0.39|||Log Rank||Hazard ratio was estimated by Cox regression model.|Stratified Analysis; Stratification factors: 17p deletion, risk status, geographic region.||0.39|0.23|<.0001
72584558|NCT04498182|144700537|SUPERIORITY||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|2.92||0.8013|TWO_SIDED|95.0|-6.5|5.0|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||5.0|-6.5|0.8013
72584559|NCT04498182|144700538|SUPERIORITY||LS Mean Difference|0.6|STANDARD_ERROR_OF_MEAN|2.52||0.8166|TWO_SIDED|95.0|-4.4|5.5|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||5.5|-4.4|0.8166
72584560|NCT04498182|144700538|SUPERIORITY||LS Mean Difference|2.4|STANDARD_ERROR_OF_MEAN|2.52||0.3371|TWO_SIDED|95.0|-2.5|7.4|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||7.4|-2.5|0.3371
72584561|NCT04498182|144700539|SUPERIORITY|||||||0.3365|||||||Wilcoxon (Mann-Whitney)|||||||0.3365
72584562|NCT04498182|144700539|SUPERIORITY|||||||0.7323|||||||Wilcoxon (Mann-Whitney)|||||||0.7323
72584563|NCT04498182|144700540|SUPERIORITY|||||||0.1557|||||||Wilcoxon (Mann-Whitney)|||||||0.1557
72584564|NCT04498182|144700540|SUPERIORITY|||||||0.6845|||||||Wilcoxon (Mann-Whitney)|||||||0.6845
72584565|NCT04498182|144700541|SUPERIORITY||LS Mean Difference|0.6|STANDARD_ERROR_OF_MEAN|2.52||0.8166|TWO_SIDED|95.0|-4.4|5.5|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||5.5|-4.4|0.8166
72584566|NCT04498182|144700541|SUPERIORITY|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center|LS Mean Difference|2.4|STANDARD_ERROR_OF_MEAN|2.52||0.3371|TWO_SIDED|95.0|-2.5|7.4|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||7.4|-2.5|0.3371
72413480|NCT02005471|144335798|SUPERIORITY||Hazard Ratio (HR)|0.32|||<|0.0001|TWO_SIDED|95.0|0.25|0.41|||Log Rank||Hazard ratio was estimated by Cox regression model.|Unstratified Analysis||0.41|0.25|<.0001
72584567|NCT04498182|144700542|SUPERIORITY||LS Mean Difference|1.8|STANDARD_ERROR_OF_MEAN|2.81||0.5215|TWO_SIDED|95.0|-3.7|7.3|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||7.3|-3.7|0.5215
72584568|NCT04498182|144700542|SUPERIORITY||LS Mean Difference|4.2|STANDARD_ERROR_OF_MEAN|2.81||0.1312|TWO_SIDED|95.0|-1.3|9.8|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||9.8|-1.3|0.1312
72584569|NCT04498182|144700543|SUPERIORITY||LS Mean Difference|1.8|STANDARD_ERROR_OF_MEAN|2.81||0.5215|TWO_SIDED|95.0|-3.7|7.3|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||7.3|-3.7|0.5215
72584570|NCT04498182|144700543|SUPERIORITY||LS Mean Difference|4.2|STANDARD_ERROR_OF_MEAN|2.81||0.1312|TWO_SIDED|95.0|-1.3|9.8|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||9.8|-1.3|0.1312
72584571|NCT04498182|144700544|SUPERIORITY||LS Mean Difference|-4.5|STANDARD_ERROR_OF_MEAN|1.99||0.0254|TWO_SIDED|95.0|-8.4|-0.6|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||-0.6|-8.4|0.0254
72584572|NCT04498182|144700544|SUPERIORITY||LS Mean Difference|-3.0|STANDARD_ERROR_OF_MEAN|1.99||0.1362|TWO_SIDED|95.0|-6.9|0.9|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||0.9|-6.9|0.1362
72584573|NCT04498182|144700545|SUPERIORITY||LS Mean Difference|-4.5|STANDARD_ERROR_OF_MEAN|1.99||0.0254|TWO_SIDED|95.0|-8.4|-0.6|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||-0.6|-8.4|0.0254
72584574|NCT04498182|144700545|SUPERIORITY||LS Mean Difference|-3.0|STANDARD_ERROR_OF_MEAN|1.99||0.1362|TWO_SIDED|95.0|-6.9|0.9|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||0.9|-6.9|0.1362
72584575|NCT04498182|144700546|SUPERIORITY||LS Mean Difference|-3.9|STANDARD_ERROR_OF_MEAN|2.06||0.0573|TWO_SIDED|95.0|-8.0|0.1|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||0.1|-8.0|0.0573
72584576|NCT04498182|144700546|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|2.06||0.993|TWO_SIDED|95.0|-4.0|4.1|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||4.1|-4.0|0.9930
72552175|NCT00048581|144635016|SUPERIORITY_OR_OTHER||Est. of Diff: Day 15 ACR 50|2.3||||0.001|TWO_SIDED|95.0|-0.8|5.5|||Cochran-Mantel-Haenszel|All statistical tests and CI were 2-sided. Percentage of participants with response compared by estimate of difference (Est of Diff)||If ACR20 comparison was significant (5% level), then CMH Chi-square test compared ACR 50 response between groups (5% level). If the ACR20 analysis was not significant (5% level), then the comparison for ACR 50 response was not undertaken. A 2-sided Cochran-Mantel-Haenszel (CMH) Chi-square test was used to compare these two treatment groups at the .05 level of significance, with stratification based on baseline history of anti-TNF status (current or prior use).||5.5|-0.8|0.001
72584577|NCT04498182|144700547|SUPERIORITY||LS Mean Difference|-3.9|STANDARD_ERROR_OF_MEAN|2.06||0.0573|TWO_SIDED|95.0|-8.0|0.1|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||0.1|-8.0|0.0573
72584578|NCT04498182|144700547|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|2.06||0.993|TWO_SIDED|95.0|-4.0|4.1|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||4.1|-4.0|0.9930
72584579|NCT04498182|144700548|SUPERIORITY||Odds Ratio (OR)|1.48||||0.3068|TWO_SIDED|95.0|0.7|3.15|||Cochran-Mantel-Haenszel|Adjusted by analysis center||||3.15|0.70|0.3068
72584580|NCT04498182|144700548|SUPERIORITY||Odds Ratio (OR)|1.22||||0.6167|TWO_SIDED|95.0|0.56|2.68|||Cochran-Mantel-Haenszel|Adjusted by analysis center||||2.68|0.56|0.6167
72584581|NCT04498182|144700549|SUPERIORITY||Odds Ratio (OR)|0.64||||0.2867|TWO_SIDED|95.0|0.28|1.46|||Cochran-Mantel-Haenszel|Adjusted by analysis center||||1.46|0.28|0.2867
72584582|NCT04498182|144700549|SUPERIORITY||Odds Ratio (OR)|0.7||||0.3803|TWO_SIDED|95.0|0.32|1.57|||Cochran-Mantel-Haenszel|Adjusted by analysis center||||1.57|0.32|0.3803
72584583|NCT04498182|144700550|SUPERIORITY||Odds Ratio (OR)|1.44||||0.4375|TWO_SIDED|95.0|0.58|3.58|||Cochran-Mantel-Haenszel|Adjusted by analysis center||||3.58|0.58|0.4375
72584584|NCT04498182|144700550|SUPERIORITY||Odds Ratio (OR)|1.3||||0.584|TWO_SIDED|95.0|0.51|3.27|||Cochran-Mantel-Haenszel|Adjusted by analysis center||||3.27|0.51|0.5840
72584585|NCT04498182|144700551|SUPERIORITY||Odds Ratio (OR)|0.73||||0.5046|TWO_SIDED|95.0|0.29|1.84|||Cochran-Mantel-Haenszel|Adjusted by analysis center||||1.84|0.29|0.5046
72584586|NCT04498182|144700551|SUPERIORITY||Odds Ratio (OR)|1.27||||0.5751|TWO_SIDED|95.0|0.56|2.88|||Cochran-Mantel-Haenszel|Adjusted by analysis center||||2.88|0.56|0.5751
72584587|NCT02667704|144700554|SUPERIORITY_OR_OTHER||Ratio of geometric means in percentage|98.85|STANDARD_DEVIATION|11.4|||TWO_SIDED|90.0|91.32|107.01|||ANOVA||Relative bioavailability was estimated by the ratio (T/R) of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient of variation.|Analysis of variance (ANOVA) model on the log scale including treatment as fixed effect and subject as a random effect||107.010|91.320|
72584588|NCT02667704|144700555|SUPERIORITY_OR_OTHER||Ratio of geometric means in percentage|103.36|STANDARD_DEVIATION|26.5|||TWO_SIDED|90.0|86.134|124.025|||ANOVA||Relative bioavailability was estimated by the ratio (T/R) of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient of variation.|Analysis of variance (ANOVA) model on the log scale including treatment as fixed effect and subject as a random effect||124.025|86.134|
72584589|NCT02667704|144700556|SUPERIORITY_OR_OTHER||Ratio of geometric means in percentage|101.98|STANDARD_DEVIATION|10.3|||TWO_SIDED|90.0|94.909|109.57|||ANOVA||Relative bioavailability was estimated by the ratio (T/R) of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient of variation.|Analysis of variance (ANOVA) model on the log scale including treatment as fixed effect and subject as a random effect||109.570|94.909|
72584590|NCT00832455|144700557|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||McNemar|||||||<0.001
72552176|NCT00048581|144635016|SUPERIORITY_OR_OTHER||Est. of Diff: Day 15 ACR 70|0.8||||0.784|TWO_SIDED|95.0|-1.3|2.9|||Cochran-Mantel-Haenszel|All statistical tests and CI were 2-sided. Percentage of participants with response compared by estimate of difference (Est of Diff)||If ACR20 comparison was significant (5% level), then CMH Chi-square test compared ACR 70 response between groups (5% level). If the ACR20 analysis was not significant (5% level), then the comparison for ACR 70 response was not undertaken. A 2-sided Cochran-Mantel-Haenszel (CMH) Chi-square test was used to compare these two treatment groups at the .05 level of significance, with stratification based on baseline history of anti-TNF status (current or prior use).||2.9|-1.3|0.784
72552177|NCT00048581|144635016|SUPERIORITY_OR_OTHER||Est. of Diff: Day 29 ACR 20|14.0||||0.005|TWO_SIDED|95.0|4.0|24.0|||Cochran-Mantel-Haenszel|All statistical tests and CI were 2-sided. Percentage of participants with response compared by estimate of difference (Est of Diff)||Differences in ACR 20 between the treatment arm receiving ABA plus background DMARDs and the treatment arm receiving PLA plus background DMARDs were compared using a 2-sided Cochran-Mantel-Haenszel (CMH) Chi-square test (.05 level of significance), with stratification based on baseline history of anti-TNF status (current or prior use).||24.0|4.0|0.005
72584591|NCT00832455|144700557|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||McNemar|||||||<0.001
72584592|NCT00832455|144700559|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||McNemar-Bowker|The McNemar-Bowker test is a statistical procedure used to compare the proportion of physician satisfaction at week 0 compared to week 12.||||||<0.001
72584593|NCT00832455|144700559|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||McNemar-Bowker|The McNemar-Bowker test is a statistical procedure used to compare the proportion of physician satisfaction at week 0 compared to week 8.||||||<0.001
72584594|NCT00832455|144700560|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||McNemar-Bowker|The McNemar-Bowker test is a statistical procedure used to compare the proportion of patient satisfaction at week 0 compared to week 12.||||||<0.001
72584595|NCT00832455|144700561|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||t-test, 2 sided|Change in PACQLQ score between Week 12 and baseline is statistically different than zero||||||<0.001
72584596|NCT01011816|144700588|SUPERIORITY_OR_OTHER|||||||0.52|||||||Fisher Exact|||Null: No differenc between the percent success of Saline and BIOSTAT BIOLOGX||||0.52
72584597|NCT00343044|144700597|SUPERIORITY_OR_OTHER|||||||0.08|TWO_SIDED|||||Standard statistical methods (log-rank tests) were used in post hoc analyses that compared efficacy parameters in patients who received 1 vs 2 prior treatment regimens.|Log Rank|||Planned enrollment of 40 patients was determined assuming a median progression free survival (PFS) of 9 months (based on a median PFS of 7.2 months for low-dose, metronomic cyclophosphamide plus bevacizumab in a phase 2 study) and an analysis calculating the sample size at which the narrowing of its 95% confidence interval (CI) became greater than .2 for every 2 patients added. Progression free survival was estimated using the Kaplan-Meier method.||||.08
72552178|NCT00048581|144635016|SUPERIORITY_OR_OTHER||Est. of Diff: Day 29 ACR 50|5.6||||0.06|TWO_SIDED|95.0|-0.2|11.4|||Cochran-Mantel-Haenszel|All statistical tests and CI were 2-sided. Percentage of participants with response compared by estimate of difference (Est of Diff)||If ACR20 comparison was significant (5% level), then CMH Chi-square test compared ACR 50 response between groups (5% level). If the ACR20 analysis was not significant (5% level), then the comparison for ACR 50 response was not undertaken. A 2-sided Cochran-Mantel-Haenszel (CMH) Chi-square test was used to compare these two treatment groups at the .05 level of significance, with stratification based on baseline history of anti-TNF status (current or prior use).||11.4|-0.2|0.06
72584598|NCT00343044|144700598|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED|||||Standard statistical methods (log-rank tests) were used in post hoc analyses that compared efficacy parameters in patients who received 1 vs 2 prior treatment regimens.|Log Rank|||Overall survival(OS)was estimated using the Kaplan-Meier method.||||.02
72584599|NCT01514292|144700626|SUPERIORITY_OR_OTHER|||||||0.0001|||||||Fisher Exact|||"Hence, the hypothesis is established as:~Ho: pi \< 71.5% Ha: pi \>71.5% Thus, the objective is to conclude that the proportion of G4 Sensor-YSI points in the present study meeting the 20 mg/dL/20% criterion is no worse than the existing FDA-approved SEVEN PLUS System. The null hypothesis will be rejected if pi observed in this study is greater than 71.5%, the G4 System performance is no worse than the historical performance of the existing FDA approved CGM system will be concluded."||||0.0001
72584600|NCT01262872|144700652|NON_INFERIORITY_OR_EQUIVALENCE|Vaccine efficacy (VE) estimated as \[(1-Relative Risk (i.e. investigational vaccine over control vaccine))\*100\] with 95% CI was calculated. Denominator considered for deriving VE at a considered time point was the number of subjects with swabs cultured at this time point. Power using 2 independent proportions, 1:1 randomization ratio, 1-sided test to detect group difference, 1-sided alpha=2.5%.|VE|-7.9|||||TWO_SIDED|95.0|-36.3|14.6||||||VE-10PP-LD 3+0d vs Synflorix 3+0d - 1M post-Dose 3. The analysis aimed to compare occurrences in terms of percentage of subjects with positive nasopharyngeal sample out of the number of subjects with swabs cultured, between 2 groups, one month (M) post-dose 3 of pneumococcal vaccine administered (10PP vaccine or Synflorix™).||14.6|-36.3|
72584601|NCT01262872|144700652|NON_INFERIORITY_OR_EQUIVALENCE|Vaccine efficacy (VE) estimated as \[(1-Relative Risk (i.e. investigational vaccine over control vaccine))\*100\] with 95% CI was calculated. Denominator considered for deriving VE at a considered time point was the number of subjects with swabs cultured at this time point. Power using 2 independent proportions, 1:1 randomization ratio, 1-sided test to detect group difference, 1-sided alpha=2.5%.|VE|6.4|||||TWO_SIDED|95.0|-17.8|25.7||||||VE-10PP-LD 3+0d vs Synflorix 3+0d - 5M post-Dose 3. The analysis aimed to compare occurrences in terms of percentage of subjects with positive nasopharyngeal sample out of the number of subjects with swabs cultured, between 2 groups, five months (M) post-dose 3 of pneumococcal vaccine administered (10PP vaccine or Synflorix™).||25.7|-17.8|
72584602|NCT01262872|144700652|NON_INFERIORITY_OR_EQUIVALENCE|Vaccine efficacy (VE) estimated as \[(1-Relative Risk (i.e. investigational vaccine over control vaccine))\*100\] with 95% CI was calculated. Denominator considered for deriving VE at a considered time point was the number of subjects with swabs cultured at this time point. Power using 2 independent proportions, 1:1 randomization ratio, 1-sided test to detect group difference, 1-sided alpha=2.5%.|VE|2.5|||||TWO_SIDED|95.0|-22.6|22.5||||||VE-10PP-LD 3+0d vs Synflorix 3+0d - 8M post-Dose 3. The analysis aimed to compare occurrences in terms of percentage of subjects with positive nasopharyngeal sample out of the number of subjects with swabs cultured, between 2 groups, eight months (M) post-dose 3 of pneumococcal vaccine administered (10PP vaccine or Synflorix™).||22.5|-22.6|
72584603|NCT01262872|144700652|NON_INFERIORITY_OR_EQUIVALENCE|Vaccine efficacy (VE) estimated as \[(1-Relative Risk (i.e. investigational vaccine over control vaccine))\*100\] with 95% CI was calculated. Denominator considered for deriving VE at a considered time point was the number of subjects with swabs cultured at this time point. Power using 2 independent proportions, 1:1 randomization ratio, 1-sided test to detect group difference, 1-sided alpha=2.5%.|VE|4.5|||||TWO_SIDED|95.0|-21.4|25.0||||||VE-10PP-HD 3+0d vs Synflorix 3+0d - 1M post-Dose 3. The analysis aimed to compare occurrences in terms of percentage of subjects with positive nasopharyngeal sample out of the number of subjects with swabs cultured, between 2 groups, one month (M) post-dose 3 of pneumococcal vaccine administered (10PP vaccine or Synflorix™).||25.0|-21.4|
72584604|NCT01262872|144700652|NON_INFERIORITY_OR_EQUIVALENCE|Vaccine efficacy (VE) estimated as \[(1-Relative Risk (i.e. investigational vaccine over control vaccine))\*100\] with 95% CI was calculated. Denominator considered for deriving VE at a considered time point was the number of subjects with swabs cultured at this time point. Power using 2 independent proportions, 1:1 randomization ratio, 1-sided test to detect group difference, 1-sided alpha=2.5%.|VE|5.3|||||TWO_SIDED|95.0|-19.2|24.8||||||VE-10PP-HD 3+0d vs Synflorix 3+0d - 5M post-Dose 3. The analysis aimed to compare occurrences in terms of percentage of subjects with positive nasopharyngeal sample out of the number of subjects with swabs cultured, between 2 groups, five months (M) post-dose 3 of pneumococcal vaccine administered (10PP vaccine or Synflorix™).||24.8|-19.2|
72584605|NCT01262872|144700652|NON_INFERIORITY_OR_EQUIVALENCE|Vaccine efficacy (VE) estimated as \[(1-Relative Risk (i.e. investigational vaccine over control vaccine))\*100\] with 95% CI was calculated. Denominator considered for deriving VE at a considered time point was the number of subjects with swabs cultured at this time point. Power using 2 independent proportions, 1:1 randomization ratio, 1-sided test to detect group difference, 1-sided alpha=2.5%.|VE|0.6|||||TWO_SIDED|95.0|-24.9|20.9||||||VE-10PP-HD 3+0d vs Synflorix 3+0d - 8M post-Dose 3. The analysis aimed to compare occurrences in terms of percentage of subjects with positive nasopharyngeal sample out of the number of subjects with swabs cultured, between 2 groups, eight months (M) post-dose 3 of pneumococcal vaccine administered (10PP vaccine or Synflorix™).||20.9|-24.9|
72584606|NCT01262872|144700653|NON_INFERIORITY_OR_EQUIVALENCE|Vaccine efficacy (VE) estimated as \[(1-Relative Risk (i.e. investigational vaccine over control vaccine))\*100\] with 95% CI was calculated. Denominator considered for deriving VE at a considered time point was the number of subjects with swabs cultured at this time point. Power using 2 independent proportions, 1:1 randomization ratio, 1-sided test to detect group difference, 1-sided alpha=2.5%.|VE (see above)|6.6|||||TWO_SIDED|95.0|-18.2|26.2||||||VE-10PP-HD 2+1d vs Synflorix 2+1d - 1M post-Dose 2. The analysis aimed to compare occurrences in terms of percentage of subjects with positive nasopharyngeal sample out of the number of subjects with swabs cultured, between 2 groups, one month (M) post-dose 2 of pneumococcal vaccine administered (10PP vaccine or Synflorix™).||26.2|-18.2|
72584607|NCT01262872|144700653|NON_INFERIORITY_OR_EQUIVALENCE|Vaccine efficacy (VE) estimated as \[(1-Relative Risk (i.e. investigational vaccine over control vaccine))\*100\] with 95% CI was calculated. Denominator considered for deriving VE at a considered time point was the number of subjects with swabs cultured at this time point. Power using 2 independent proportions, 1:1 randomization ratio, 1-sided test to detect group difference, 1-sided alpha=2.5%.|VE (see above)|6.3|||||TWO_SIDED|95.0|-18.0|25.7||||||VE-10PP-HD 2+1d vs Synflorix 2+1d - 5M post-Dose 2. The analysis aimed to compare occurrences in terms of percentage of subjects with positive nasopharyngeal sample out of the number of subjects with swabs cultured, between 2 groups, five months (M) post-dose 2 of pneumococcal vaccine administered (10PP vaccine or Synflorix™).||25.7|-18.0|
72584608|NCT01262872|144700653|NON_INFERIORITY_OR_EQUIVALENCE|Vaccine efficacy (VE) estimated as \[(1-Relative Risk (i.e. investigational vaccine over control vaccine))\*100\] with 95% CI was calculated. Denominator considered for deriving VE at a considered time point was the number of subjects with swabs cultured at this time point. Power using 2 independent proportions, 1:1 randomization ratio, 1-sided test to detect group difference, 1-sided alpha=2.5%.|VE (see above)|-3.5|||||TWO_SIDED|95.0|-29.3|17.2||||||VE-10PP-HD 2+1d vs Synflorix 2+1d - 3M post-Dose 3. The analysis aimed to compare occurrences in terms of percentage of subjects with positive nasopharyngeal sample out of the number of subjects with swabs cultured, between 2 groups, three months (M) post-dose 3 of pneumococcal vaccine administered (10PP vaccine or Synflorix™).||17.2|-29.3|
72584609|NCT00365794|144700739|OTHER|||||||0.77|||||||t-test, 2 sided|||Total body mass||||0.77
72584610|NCT00365794|144700739|OTHER|||||||0.003|||||||t-test, 2 sided|||Total fat mass||||0.003
72413481|NCT02005471|144335799|SUPERIORITY||Difference in MRD Negativity Rates|49.04|||<|0.0001|TWO_SIDED|95.0|40.44|57.64|||Chi-squared||The 95% CI was computed using Anderson-Hauck method.|||57.64|40.44|<.0001
72413482|NCT02005471|144335799|SUPERIORITY||Odds Ratio (OR)|10.77|||||TWO_SIDED|95.0|6.5|17.85|||||OR was estimated using logistic regression model. The 95% CI was computed using Wald test.|||17.85|6.50|
72413483|NCT02005471|144335800|SUPERIORITY||Difference in MRD negative rates|13.41|||<|0.0001|TWO_SIDED|95.0|7.99|18.82|||Chi-squared||The 95% CI was computed using Anderson-Hauck method.|||18.82|7.99|<.0001
72552179|NCT00048581|144635016|SUPERIORITY_OR_OTHER||Est. of Diff: Day 29 ACR 70|1.6||||0.473|TWO_SIDED|95.0|-1.8|4.9|||Cochran-Mantel-Haenszel|All statistical tests and CI were 2-sided. Percentage of participants with response compared by estimate of difference (Est of Diff)||If ACR20 comparison was significant (5% level), then CMH Chi-square test compared ACR 70 response between groups (5% level). If the ACR20 analysis was not significant (5% level), then the comparison for ACR 70 response was not undertaken. A 2-sided Cochran-Mantel-Haenszel (CMH) Chi-square test was used to compare these two treatment groups at the .05 level of significance, with stratification based on baseline history of anti-TNF status (current or prior use).||4.9|-1.8|0.473
72552180|NCT00048581|144635016|SUPERIORITY_OR_OTHER||Est. of Diff: Day 57 ACR 20|22.0|||<|0.001|TWO_SIDED|95.0|11.3|32.8|||Cochran-Mantel-Haenszel|All statistical tests and CI were 2-sided. Percentage of participants with response compared by estimate of difference (Est of Diff)||Differences in ACR 20 between the treatment arm receiving ABA plus background DMARDs and the treatment arm receiving PLA plus background DMARDs were compared using a 2-sided Cochran-Mantel-Haenszel (CMH) Chi-square test (.05 level of significance), with stratification based on baseline history of anti-TNF status (current or prior use).||32.8|11.3|<0.001
72552181|NCT00048581|144635016|SUPERIORITY_OR_OTHER||Est. of Diff: Day 57 ACR 50|6.5||||0.076|TWO_SIDED|95.0|-0.6|13.7|||Cochran-Mantel-Haenszel|All statistical tests and CI were 2-sided. Percentage of participants with response compared by estimate of difference (Est of Diff)||If ACR20 comparison was significant (5% level), then CMH Chi-square test compared ACR 50 response between groups (5% level). If the ACR20 analysis was not significant (5% level), then the comparison for ACR 50 response was not undertaken. A 2-sided Cochran-Mantel-Haenszel (CMH) Chi-square test was used to compare these two treatment groups at the .05 level of significance, with stratification based on baseline history of anti-TNF status (current or prior use).||13.7|-0.6|0.076
72552182|NCT00048581|144635016|SUPERIORITY_OR_OTHER||Est. of Diff: Day 57 ACR 70|5.1||||0.019|TWO_SIDED|95.0|0.7|9.4|||Cochran-Mantel-Haenszel|All statistical tests and CI were 2-sided. Percentage of participants with response compared by estimate of difference (Est of Diff)||If ACR20 comparison was significant (5% level), then CMH Chi-square test compared ACR 70 response between groups (5% level). If the ACR20 analysis was not significant (5% level), then the comparison for ACR 70 response was not undertaken. A 2-sided Cochran-Mantel-Haenszel (CMH) Chi-square test was used to compare these two treatment groups at the .05 level of significance, with stratification based on baseline history of anti-TNF status (current or prior use).||9.4|0.7|0.019
72552183|NCT00048581|144635016|SUPERIORITY_OR_OTHER||Est. of Diff: Day 85 ACR 20|28.0|||<|0.001|TWO_SIDED|95.0|17.4|38.7|||Cochran-Mantel-Haenszel|All statistical tests and CI were 2-sided. Percentage of participants with response compared by estimate of difference (Est of Diff)||Differences in ACR 20 between the treatment arm receiving ABA plus background DMARDs and the treatment arm receiving PLA plus background DMARDs were compared using a 2-sided Cochran-Mantel-Haenszel (CMH) Chi-square test (.05 level of significance), with stratification based on baseline history of anti-TNF status (current or prior use).||38.7|17.4|<0.001
72552184|NCT00048581|144635016|SUPERIORITY_OR_OTHER||Est. of Diff: Day 85 ACR 50|12.0||||0.002|TWO_SIDED|95.0|4.1|19.8|||Cochran-Mantel-Haenszel|All statistical tests and CI were 2-sided. Percentage of participants with response compared by estimate of difference (Est of Diff)||If ACR20 comparison was significant (5% level), then CMH Chi-square test compared ACR 50 response between groups (5% level). If the ACR20 analysis was not significant (5% level), then the comparison for ACR 50 response was not undertaken. A 2-sided Cochran-Mantel-Haenszel (CMH) Chi-square test was used to compare these two treatment groups at the .05 level of significance, with stratification based on baseline history of anti-TNF status (current or prior use).||19.8|4.1|0.002
72552185|NCT00048581|144635016|SUPERIORITY_OR_OTHER||Est. of Diff: Day 85 ACR 70|5.1||||0.033|TWO_SIDED|95.0|0.4|9.8|||Cochran-Mantel-Haenszel|All statistical tests and CI were 2-sided. Percentage of participants with response compared by estimate of difference (Est of Diff)||If ACR20 comparison was significant (5% level), then CMH Chi-square test compared ACR 70 response between groups (5% level). If the ACR20 analysis was not significant (5% level), then the comparison for ACR 70 response was not undertaken. A 2-sided Cochran-Mantel-Haenszel (CMH) Chi-square test was used to compare these two treatment groups at the .05 level of significance, with stratification based on baseline history of anti-TNF status (current or prior use).||9.8|0.4|0.033
72552186|NCT00048581|144635016|SUPERIORITY_OR_OTHER||Est. of Diff: Day 113 ACR 20|25.9|||<|0.001|TWO_SIDED|95.0|15.1|36.8|||Cochran-Mantel-Haenszel|All statistical tests and CI were 2-sided. Percentage of participants with response compared by estimate of weighted difference (Est of Weighted Diff)||Differences in ACR 20 between the treatment arm receiving ABA plus background DMARDs and the treatment arm receiving PLA plus background DMARDs were compared using a 2-sided Cochran-Mantel-Haenszel (CMH) Chi-square test (.05 level of significance), with stratification based on baseline history of anti-TNF status (current or prior use).||36.8|15.1|<0.001
72413484|NCT02005471|144335800|SUPERIORITY||Odds Ratio (OR)|16.28|||||TWO_SIDED|95.0|3.82|69.35|||||OR was estimated using logistic regression model. The 95% CI was computed using Wald test.|||69.35|3.82|
72552187|NCT00048581|144635016|SUPERIORITY_OR_OTHER||Est. of Diff: Day 113 ACR 50|14.2|||<|0.001|TWO_SIDED|95.0|6.6|21.9|||Cochran-Mantel-Haenszel|All statistical tests and CI were 2-sided. Percentage of participants with response compared by estimate of weighted difference (Est of Weighted Diff)||If ACR20 comparison was significant (5% level), then CMH Chi-square test compared ACR 50 response between groups (5% level). If the ACR20 analysis was not significant (5% level), then the comparison for ACR 50 response was not undertaken. A 2-sided Cochran-Mantel-Haenszel (CMH) Chi-square test was used to compare these two treatment groups at the .05 level of significance, with stratification based on baseline history of anti-TNF status (current or prior use).||21.9|6.6|<0.001
72584611|NCT00365794|144700739|OTHER|||||||0.0007|||||||t-test, 2 sided|||Statistical analysis is for change in trunk fat mass after 20 weeks of testosterone gel.||||0.0007
72584612|NCT00365794|144700739|OTHER|||||||0.01|||||||t-test, 2 sided|||Statistical analysis is for change in extremity fat mass after 20 weeks of testosterone gel.||||0.01
72584613|NCT00365794|144700740|OTHER|||||||0.12||||||No adjustment in p for multiple comparisons.|t-test, 2 sided|||||||0.12
72584614|NCT00365794|144700741|OTHER|||||||0.008|||||||t-test, 2 sided|||||||0.008
72584615|NCT00365794|144700742|OTHER|||||||0.0002||||||No adjustment for multiple comparisons.|t-test, 2 sided|||||||0.0002
72413485|NCT00627705|144335818|SUPERIORITY_OR_OTHER|||||||0.449|||||||mixed effects regression models|F= 0.81||Cohen's d = 0.30||||0.449
72584616|NCT00365794|144700743|OTHER|||||||0.04|||||||t-test, 2 sided|||Statistical analysis for change in whole body insulin sensitivity after treatment with testosterone gel for 20 weeks.||||0.04
72584617|NCT00365794|144700743|OTHER|||||||0.59|||||||t-test, 2 sided|||Statistical analysis for change in hepatic glucose output (measure of central insulin sensitivity) after treatment with testosterone gel for 20 weeks||||0.59
72584618|NCT00365794|144700743|OTHER|||||||0.03|||||||t-test, 2 sided|||Statistical analysis for change in rate of peripheral glucose disposal (test of peripheral insulin sensitivity) after treatment with testosterone gel for 20 weeks||||0.03
72584619|NCT00365794|144700744|OTHER|||||||0.0006|||||||t-test, 2 sided|||Change in DEXA extremity (appendicular) lean tissue, a measure of extremity muscle mass after 20 weeks ot treatent with testosterone gel.||||0.0006
72584620|NCT00365794|144700745|OTHER|Test for fasting triglycerides||||||0.02|||||||t-test, 2 sided|||A change in 20 plasma lipids (fasting triglycerides and lipid fractions) after 20 weeks of treatment with testosterone gel.||||0.02
72584621|NCT00365794|144700745|OTHER|Test for total cholesterol||||||0.004|||||||t-test, 2 sided|||A change in 20 plasma lipids (fasting triglycerides and lipid fractions) after 20 weeks of treatment with testosterone gel||||0.004
72584622|NCT00365794|144700745|OTHER|Test for LDL cholesterol||||||0.02|||||||t-test, 2 sided|||nts A change in 20 plasma lipids (fasting triglycerides and lipid fractions) after 20 weeks of treatment with testosterone gel||||.02
72413486|NCT00627705|144335820|SUPERIORITY_OR_OTHER||||||<|0.001||||||Aberrant Behavior Checklist irritability subscale (F = 6.80; p = \<.001; d = .96).|Mixed effects regression models|||F values were derived from the interaction of participant group (NAC vs. placebo) and time (week) in mixed effects regression models. Cohen's d was computed based on the standardized mean difference in the change from baseline to week 12.||||<.001
72584623|NCT00365794|144700745|OTHER|Test for HDL cholesterol||||||0.004|||||||t-test, 2 sided|||A change in 20 plasma lipids (fasting triglycerides and lipid fractions) after 20 weeks of treatment with testosterone gel||||0.004
72584624|NCT00365794|144700746|OTHER|||||||0.06|||||||t-test, 2 sided|||||||0.06
72584625|NCT00365794|144700747|OTHER|||||||0.97|||||||t-test, 2 sided|||||||0.97
72584626|NCT00365794|144700748|OTHER|||||||0.83|||||||t-test, 2 sided|||||||0.83
72584627|NCT00745901|144700749|SUPERIORITY_OR_OTHER|||||||0.9698||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.9698
72584628|NCT00745901|144700750|SUPERIORITY_OR_OTHER|||||||0.0715||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0715
72584629|NCT00745901|144700751|SUPERIORITY_OR_OTHER|||||||0.005||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0050
72584630|NCT00745901|144700752|SUPERIORITY_OR_OTHER|||||||0.0006||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0006
72584631|NCT00745901|144700753|SUPERIORITY_OR_OTHER|||||||0.0031||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0031
72584632|NCT00745901|144700754|SUPERIORITY_OR_OTHER|||||||0.0013||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0013
72584633|NCT00745901|144700755|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.0001
72584634|NCT00745901|144700756|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.0001
72584635|NCT00745901|144700757|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.0001
72584636|NCT00745901|144700758|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.0001
72584637|NCT00745901|144700759|SUPERIORITY_OR_OTHER|||||||0.0033||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0033
72584638|NCT00745901|144700760|SUPERIORITY_OR_OTHER|||||||0.006||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0060
72584639|NCT00745901|144700761|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.0001
72584640|NCT00745901|144700762|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.0001
72584641|NCT00745901|144700763|SUPERIORITY_OR_OTHER|||||||0.912||95.0|||||Fisher Exact|||||||0.912
72584642|NCT00745901|144700764|SUPERIORITY_OR_OTHER|||||||0.003||95.0|||||Fisher Exact|||||||0.003
72584643|NCT00745901|144700765|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||Fisher Exact|||||||0.002
72584644|NCT00745901|144700766|SUPERIORITY_OR_OTHER|||||||0.816||95.0|||||Fisher Exact|||||||0.816
72584645|NCT00745901|144700767|SUPERIORITY_OR_OTHER|||||||0.012||95.0|||||Fisher Exact|||||||0.012
72584646|NCT00745901|144700768|SUPERIORITY_OR_OTHER|||||||0.003||95.0|||||Fisher Exact|||||||0.003
72584647|NCT03859427|144700771|NON_INFERIORITY|The non-inferiority margin was 0.87 for the estimated ORR risk ratio.|Risk Ratio (RR)|0.954||||0.0666|TWO_SIDED|95.0|0.882|1.032||P-value (2.5% significance level) of the non-inferiority test via the synthesis approach (FDA, 2016) for non-inferiority comparison of ORR between treatment arms.|Synthesis approach||Risk ratio and 95% CIs were estimated by a stratified analysis using the Cochran-Mantel-Haenszel method.|||1.032|0.882|0.0666
72584648|NCT03859427|144700773|OTHER||Odds Ratio (OR)|1.049|||||TWO_SIDED|95.0|0.653|1.683|||||Odds ratio and 95% CIs were estimated by a stratified analysis using the Cochran-Mantel-Haenszel method.|||1.683|0.653|
72584649|NCT03859427|144700779|OTHER||Odds Ratio (OR)|1.235|||||TWO_SIDED|95.0|0.775|1.97|||||Odds ratio and 95% CIs were estimated by a stratified analysis using the Cochran-Mantel-Haenszel method.|||1.970|0.775|
72584650|NCT03859427|144700780|OTHER||Odds Ratio (OR)|1.06|||||TWO_SIDED|95.0|0.657|1.711|||||Odds ratio and 95% CIs were estimated by a stratified analysis using the Cochran-Mantel-Haenszel method.|||1.711|0.657|
72584651|NCT03859427|144700781|OTHER||Least Squares (LS) Mean Difference|2.53|||||TWO_SIDED|95.0|0.38|4.69|||||Analysis was based on repeated measures analysis of covariance (ANCOVA) model, including arm, baseline scale score, randomization stratification factors and visit as repeated measure.|||4.69|0.38|
72584652|NCT03859427|144700782|OTHER||LS Mean Difference|1.73|||||TWO_SIDED|95.0|-1.26|4.72|||||Analysis was based on ANCOVA model, including arm, baseline scale score, randomization stratification factors and visit as repeated measure.|||4.72|-1.26|
72584653|NCT03859427|144700783|OTHER||LS Mean difference|-0.26|STANDARD_ERROR_OF_MEAN|1.16|||TWO_SIDED|95.0|-2.54|2.03|||||Treatment difference at Cycle 5|||2.03|-2.54|
72584654|NCT03859427|144700783|OTHER||LS Mean difference|-0.48|STANDARD_ERROR_OF_MEAN|1.4|||TWO_SIDED|95.0|-3.24|2.28|||||Treatment difference at Cycle 12|||2.28|-3.24|
72584655|NCT03859427|144700783|OTHER||LS Mean difference|1.44|STANDARD_ERROR_OF_MEAN|1.59|||TWO_SIDED|95.0|-1.69|4.58|||||Treatment difference at safety follow-up|||4.58|-1.69|
72584656|NCT03175536|144700806|SUPERIORITY||Mean Difference (Net)|3.4||||0.05|TWO_SIDED|95.0|-5.2|12.1|||GEE models|Negative binomial regression with GEE model; term of interest was interaction between study group and time period (baseline vs follow-up year).|Using terms from the regression model, we applied marginal effects methods to calculate mean adjusted baseline and follow-up PDC and absolute changes|||12.1|-5.2|0.05
72584657|NCT03175536|144700807|SUPERIORITY||Mean Difference (Net)|1.3||||0.05|TWO_SIDED|95.0|-4.4|7.0|||GEE model|Negative binomial regression with GEE model; term of interest was interaction between study group and time period (baseline vs follow-up year).|Using terms from the regression model, we applied marginal effects methods to calculate mean adjusted baseline and follow-up PDC and absolute changes|||7.0|-4.4|0.05
72584658|NCT03175536|144700808|SUPERIORITY||Mean Difference (Net)|6.0||||0.05|TWO_SIDED|95.0|0.7|11.3|||GEE model|Binomial regression with GEE model; term of interest was interaction between study group and time period (baseline vs follow-up year).|Using terms from the regression model, we applied marginal effects methods to calculate mean adjusted baseline and follow-up PDC and absolute changes.|||11.3|0.7|0.05
72584659|NCT03175536|144700809|SUPERIORITY||Mean Difference (Net)|0.16||||0.05|TWO_SIDED|95.0|-0.74|1.06|||GEE model|Negative binomial regression with GEE model; term of interest was interaction between study group and time period (baseline vs follow-up year).|Using terms from the regression model, we applied marginal effects methods to calculate mean adjusted baseline and follow-up PDC and absolute changes|||1.06|-0.74|0.05
72584660|NCT03175536|144700810|SUPERIORITY||Median Difference (Net)|-34.0||||0.05|TWO_SIDED|95.0|-47.0|-21.0|||GEE model|Negative binomial regression with GEE model; term of interest was interaction between study group and time period (baseline vs follow-up year).|Using terms from the regression model, we applied marginal effects methods to calculate mean adjusted baseline and follow-up PDC and absolute changes.|||-21|-47|0.05
72584661|NCT01804946|144700811|NON_INFERIORITY_OR_EQUIVALENCE|The pre-determined margin of 20% of the control group effect was used.|Risk Difference (RD)|0.0||||0.05|ONE_SIDED|95.0||||One-sided, p-value was adjusted for multiple comparisons using the adaptive Holm method|Wald method of Z statistics calculation|Wald method of Z statistics computed a confidence interval of proportion difference.||PP set was analyzed||||0.05
72584662|NCT01804946|144700812|NON_INFERIORITY_OR_EQUIVALENCE|The pre-determined margin of 20% of the control group effect was used.|Risk Difference (RD)|0.0|||<|0.05|ONE_SIDED|95.0||||One-sided, p-value was adjusted for multiple comparisons using the adaptive Holm method|Wald method of Z statistics calculation|Wald method of Z statistics computed a confidence interval of proportion difference.||PP set was analyzed||||<0.05
72413487|NCT00627705|144335822|SUPERIORITY_OR_OTHER|||||||0.141|||||||mixed effects regression models|degrees of freedom were 1, 22||F-values were derived from the interaction of Participant Group (NAC vs. Placebo) and Time (Week) in mixed effects regression models.||||.141
72413488|NCT02099006|144335832|SUPERIORITY_OR_OTHER|||||||0.3|||||||t-test, 2 sided|Paired T test||Null hypothesis - that the improvement in daily genital pain would be no different with the daily application of loperamide than with the daily application of a placebo cream.||||0.30
72413489|NCT02099006|144335832|SUPERIORITY_OR_OTHER|||||||0.33|||||||t-test, 2 sided|Paired||Null hypothesis - that the improvement in daily genital pain would be no different with the daily application of ketamine than with the daily application of a placebo cream.||||0.33
72413490|NCT02099006|144335832|SUPERIORITY_OR_OTHER|||||||0.65|||||||t-test, 2 sided|paired||Null hypothesis - that the improvement in daily genital pain would be no different with the daily application of gabapentin than with the daily application of a placebo cream.||||0.65
72584663|NCT01804946|144700813|NON_INFERIORITY_OR_EQUIVALENCE|The clinically significant margin was assumed to be 0.2 of Oseltamivir effect|Mean Difference (Final Values)|0.0|||<|0.05|ONE_SIDED|95.0||||To adjust for multiple comparisons, the adaptive Holm method was used as a way to control type 1 error|t-test, 1 sided|Means were compared using the modified two-sample Student t-test including computation of a confidence interval for a difference between means||PP set was analyzed||||<0.05
72584664|NCT01804946|144700814|NON_INFERIORITY_OR_EQUIVALENCE|The clinically significant margin was assumed to be 0.2°C|Mean Difference (Final Values)|0.0|STANDARD_DEVIATION|0.5|<|0.05|ONE_SIDED|95.0||||To adjust for multiple comparisons, the adaptive Holm method was used as a way to control type 1 error|t-test, 1 sided|Means were compared using the modified two-sample Student t-test including computation of a confidence interval for a difference between means.||PP set was analyzed||||<0.05
72584665|NCT01804946|144700815|NON_INFERIORITY_OR_EQUIVALENCE|The margin of no clinical importance was assumed to be 0.5 point or less to assess any symptom based on 4 point scale.|Mean Difference (Final Values)|0.0|||<|0.05|ONE_SIDED|95.0||||To adjust for multiple comparisons the adaptive Holm method was used as a way to control type 1 error|t-test, 1 sided|Means were compared using the modified two-sample Student t-test including computation of a confidence interval for a difference between means||PP set was analyzed||||<0.05
72584666|NCT01804946|144700816|NON_INFERIORITY_OR_EQUIVALENCE|To compare the number of antipyretic intake the margin of no clinical importance was assumed to be 0.2|Mean Difference (Final Values)|0.0|STANDARD_DEVIATION|0.5|<|0.05|ONE_SIDED|95.0||||To adjust for multiple comparisons, the adaptive Holm method was used as a way to control type 1 error|t-test, 1 sided|Means were compared using the modified two-sample Student t-test including computation of a confidence interval for a difference between means||PP set was analyzed||||<0.05
72584667|NCT01804946|144700817|NON_INFERIORITY_OR_EQUIVALENCE|To compare the quality of life total score the margin of no clinical importance was assumed to be 0.2 of Oseltamivir group value|Mean Difference (Final Values)|0.0|STANDARD_DEVIATION|2.2|<|0.05|ONE_SIDED|95.0||||To adjust for multiple comparisons, the adaptive Holm method was used as a way to control type 1 error|t-test, 1 sided|The changes of means (Day 7 vs Day 1) were compared using the modified two-sample Student t-test including computation of a confidence interval||PP set was analyzed||||<0.05
72584668|NCT01804946|144700818|NON_INFERIORITY_OR_EQUIVALENCE|To compare the patient subjective health status assessment the margin of no clinical importance was assumed to be 0.2 of Oseltamivir group value|Mean Difference (Final Values)|0.0|STANDARD_DEVIATION|18.2|<|0.05|ONE_SIDED|95.0||||To adjust for multiple comparisons, the adaptive Holm method was used as a way to control type 1 error|t-test, 1 sided|Changes of means (Day 7 vs Day 1) were compared using the modified two-sample Student t-test including computation of a confidence interval||PP set was analyzed||||<0.05
72584669|NCT01804946|144700819|NON_INFERIORITY_OR_EQUIVALENCE|The clinically significant difference (margin) between two percentages was assumed to be 20% or more of the effect of Oseltamivir|Risk Difference (RD)|0.0|||<|0.05|ONE_SIDED|95.0|||||The Wald method of Z statistics calcul|The Wald method of Z statistics calculation was performed including computation a confidence interval for a difference between proportions||PP set was analyzed||||<0.05
72584670|NCT00722137|144700820|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.63|||<|0.001|TWO_SIDED|95.0|0.5|0.79|||Log Rank|Based on Log rank test stratified with International Prognostic Index (IPI) risk and stage of disease.|Hazards ratio estimate is based on a Cox´s model stratified by IPI risk and stage of disease. A hazard ratio \< 1 indicates an advantage for VcR-CAP.|||0.79|0.50|<0.001
72584671|NCT00722137|144700821|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.58|||<|0.001|TWO_SIDED|95.0|0.45|0.74|||Log Rank|Based on Log rank test stratified with IPI risk and stage of disease.|Hazards ratio estimate is based on a Cox´s model stratified by IPI risk and stage of disease. A hazard ratio \< 1 indicates an advantage for VcR-CAP.|||0.74|0.45|<0.001
72584672|NCT00722137|144700823|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.5|||<|0.001|TWO_SIDED|95.0|0.38|0.65|||Log Rank|Based on Log rank test stratified with IPI risk and stage of disease.|Hazards ratio estimate is based on a Cox´s model stratified by IPI risk and stage of disease. A hazard ratio \< 1 indicates an advantage for VcR-CAP.|||0.65|0.38|<0.001
72584673|NCT00722137|144700824|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.5|||=|0.001|TWO_SIDED|95.0|0.38|0.65|||Log Rank|||||0.65|0.38|=0.001
72413491|NCT02099006|144335832|SUPERIORITY_OR_OTHER|||||||0.25|||||||t-test, 2 sided|Paired||Null hypothesis - that the improvement in daily genital pain would be no different with the daily application of amitriptyline and baclofen than with the daily application of a placebo cream.||||0.25
72584674|NCT00722137|144700825|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.428||||0.275|TWO_SIDED|95.0|0.749|2.722|||Cochran-Mantel-Haenszel Chi-Square||Mantel-Haenszel estimate of the common odds ratio for stratified tables is used, with IPI risk and Stage of Disease as stratification factors. An odds ratio (OR) \> 1 indicates an advantage for VcR-CAP.|||2.722|0.749|0.275
72584675|NCT00722137|144700826|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.688|||<|0.007|TWO_SIDED|95.0|1.148|2.481|||Cochran-Mantel-Haenszel Chi-Square||Mantel-Haenszel estimate of the common odds ratio for stratified tables is used, with IPI risk and Stage of Disease as stratification factors. An odds ratio (OR) \> 1 indicates an advantage for VcR-CAP.|||2.481|1.148|<0.007
72584676|NCT00722137|144700827|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.8||||0.173|TWO_SIDED|95.0|0.59|1.1|||Log Rank|Based on Log rank test stratified with IPI risk and stage of disease.|Hazards ratio estimate is based on a Cox´s model stratified by IPI risk and stage of disease. A hazard ratio \< 1 indicates an advantage for VcR-CAP.|||1.10|0.59|0.173
72584677|NCT02999269|144700890|SUPERIORITY|||||||0.04||||||p-value for time by amplitude interaction|Regression, Linear|||For the primary outcomes (change in HDRS24), we performed a full longitudinal model with an unstructured repeated measures covariance matrix on subjects who completed the study in the assigned treatment arm. The dependent variable was HDRS at each visit and the independent variables included progress (time within the ECT series: pre-, mid-, and post-ECT), amplitude, age, sex, pulse width and the following interactions: progress/amplitude, progress/sex, and progress/pulse width.|Time-by-amplitude interaction (F4, 72 = 2.65, p = 0.04).|||0.04
72584678|NCT02999269|144700890|SUPERIORITY|||||||0.0001|||||||Regression, Linear|||||||0.0001
72413492|NCT02099006|144335832|SUPERIORITY_OR_OTHER|||||||1|||||||t-test, 2 sided|Paired||Null hypothesis - that the improvement in daily genital pain would be no different with the daily application of ketoprofen than with the daily application of a placebo cream.||||1.0
72584679|NCT02999269|144700891|SUPERIORITY|||||||0.37|||||||Regression, Linear|||||||0.37
72413493|NCT02099006|144335833|SUPERIORITY_OR_OTHER|||||||0.31|||||||t-test, 2 sided|paired||Null hypothesis - that the improvement in tampon test pain would be no different with the daily application of loperamide cream than with the daily application of a placebo cream.||||0.31
72413494|NCT02099006|144335833|SUPERIORITY_OR_OTHER|||||||1|||||||t-test, 2 sided|Paired||Null hypothesis - that the improvement in tampon test pain would be no different with the daily application of ketamine cream than with the daily application of a placebo cream.||||1
72584680|NCT02999269|144700891|SUPERIORITY|||||||0.5||||||p-value is time-by-amplitude interaction|Regression, Linear|||||||0.50
72584681|NCT02999269|144700891|SUPERIORITY||||||<|0.01||||||Progress (F2,71 = 11.15, p \< 0.01)|Regression, Linear|||||||< 0.01
72584682|NCT01120184|144700893|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The study was powered for superiority with target hazard ratio (HR) equal to 0.75, as well as for non-inferiority with HR equal to 1.1765 for comparison between each of the trastuzumab emtansine-containing arms and the trastuzumab + taxane arm. Non-inferiority was established if the upper bound of the 97.5% CI was less than (\<) 1.1765. Superiority was achieved if the upper bound of the 97.5% CI was \<1.00.|Hazard Ratio (HR)|0.91||||0.3125|TWO_SIDED|97.5|0.73|1.13||Test and p-value apply for superiority test. Two-sided significance level of 2.5% was used to adjust for independent comparison between each of the trastuzumab emtansine-containing arms and the trastuzumab + taxane arm.|Log Rank||Direction of comparison: Trastuzumab Emtansine + Placebo vs. Trastuzumab + Taxane|Stratified Analysis: Stratification factors included world region (United States, Western Europe/Canada/Australia-Pacific, Eastern Europe, Asia, others); prior adjuvant/neoadjuvant therapy (no, yes \[trastuzumab and/or lapatinib\], yes \[no trastuzumab and/or lapatinib\]), and visceral disease (present, absent).||1.13|0.73|0.3125
72584683|NCT01120184|144700893|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The study was powered for superiority with target HR equal to 0.75, as well as for non-inferiority with HR equal to 1.1765 for comparison between each of the trastuzumab emtansine-containing arms and the trastuzumab + taxane arm. Non-inferiority was established if the upper bound of the 97.5% CI was \<1.1765. Superiority was achieved if the upper bound of the 97.5% CI was \<1.00.|Hazard Ratio (HR)|0.87||||0.1407|TWO_SIDED|97.5|0.69|1.08||Test and p-value apply for superiority test. Two-sided significance level of 2.5% was used to adjust for independent comparison between each of the trastuzumab emtansine-containing arms and the trastuzumab + taxane arm.|Log Rank||Direction of comparison: Trastuzumab Emtansine + Pertuzumab vs. Trastuzumab + Taxane|Stratified Analysis: Stratification factors included world region (United States, Western Europe/Canada/Australia-Pacific, Eastern Europe, Asia, others); prior adjuvant/neoadjuvant therapy (no, yes \[trastuzumab and/or lapatinib\], yes \[no trastuzumab and/or lapatinib\]), and visceral disease (present, absent).||1.08|0.69|0.1407
72584684|NCT01120184|144700893|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The study was powered for superiority with target HR equal to 0.75, as well as for non-inferiority with HR equal to 1.1765 for comparison between each of the trastuzumab emtansine-containing arms and the trastuzumab + taxane arm.|Hazard Ratio (HR)|0.91||||0.3075|TWO_SIDED|97.5|0.73|1.13||Test and p-value apply for superiority test. Primary endpoint did not meet superiority of PFS for trastuzumab emtansine + pertuzumab versus trastuzumab + taxane (two-sided significance level 2.5%); thus, tests and p-value are considered descriptive.|Log Rank||Direction of comparison: Trastuzumab Emtansine + Pertuzumab vs. Trastuzumab Emtansine + Placebo|Stratified Analysis: Stratification factors included world region (United States, Western Europe/Canada/Australia-Pacific, Eastern Europe, Asia, others); prior adjuvant/neoadjuvant therapy (no, yes \[trastuzumab and/or lapatinib\], yes \[no trastuzumab and/or lapatinib\]), and visceral disease (present, absent).||1.13|0.73|0.3075
72584685|NCT01120184|144700895|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.93||||0.6568|TWO_SIDED|97.5|0.73|1.2|||Log Rank||Direction of comparison: Trastuzumab Emtansine + Placebo vs Trastuzumab + Taxane|Stratified Analysis: Stratification factors included world region (United States, Western Europe/Canada/Australia-Pacific, Eastern Europe, Asia, others); prior adjuvant/neoadjuvant therapy (no, yes \[trastuzumab and/or lapatinib\], yes \[no trastuzumab and/or lapatinib\]), and visceral disease (present, absent).||1.20|0.73|0.6568
72584686|NCT01120184|144700895|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.86||||0.5691|TWO_SIDED|97.5|0.67|1.11|||Log Rank||Direction of comparison: Trastuzumab Emtansine + Pertuzumab vs Trastuzumab + Taxane|Stratified Analysis: Stratification factors included world region (United States, Western Europe/Canada/Australia-Pacific, Eastern Europe, Asia, others); prior adjuvant/neoadjuvant therapy (no, yes \[trastuzumab and/or lapatinib\], yes \[no trastuzumab and/or lapatinib\]), and visceral disease (present, absent).||1.11|0.67|0.5691
72584687|NCT01120184|144700897|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.85|||||TWO_SIDED|97.5|0.69|1.04|||||Direction of comparison: Trastuzumab Emtasine + Placebo vs Trastuzumab + Taxane|Stratified Analysis: Stratification factors included world region (United States, Western Europe/Canada/Australia-Pacific, Eastern Europe, Asia, others); prior adjuvant/neoadjuvant therapy (no, yes \[trastuzumab and/or lapatinib\], yes \[no trastuzumab and/or lapatinib\]), and visceral disease (present, absent).||1.04|0.69|
72584688|NCT01120184|144700897|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.77|||||TWO_SIDED|97.5|0.63|0.95|||||Direction of comparison: Trastuzumab Emtansine + Pertuzumab vs Trastuzumab + Taxane|Stratified Analysis: Stratification factors included world region (United States, Western Europe/Canada/Australia-Pacific, Eastern Europe, Asia, others); prior adjuvant/neoadjuvant therapy (no, yes \[trastuzumab and/or lapatinib\], yes \[no trastuzumab and/or lapatinib\]), and visceral disease (present, absent).||0.95|0.63|
72584689|NCT01120184|144700899|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.8|||||TWO_SIDED|97.5|0.66|0.97|||||Direction of comparison: Trastuzumab Emtansine + Placebo vs Trastuzumab + Taxane|Stratified Analysis: Stratification factors included world region (United States, Western Europe/Canada/Australia-Pacific, Eastern Europe, Asia, others); prior adjuvant/neoadjuvant therapy (no, yes \[trastuzumab and/or lapatinib\], yes \[no trastuzumab and/or lapatinib\]), and visceral disease (present, absent).||0.97|0.66|
72413495|NCT02099006|144335833|SUPERIORITY_OR_OTHER|||||||0.66|||||||t-test, 2 sided|Paired||Null hypothesis - that the improvement in tampon test pain would be no different with the daily application of gabapentin cream than with the daily application of a placebo cream.||||0.66
72584690|NCT01120184|144700899|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.78|||||TWO_SIDED|97.5|0.65|0.95|||||Direction of comparison: Trastuzumab Emtansine + Pertuzumab vs Trastuzumab + Taxane|Stratified Analysis: Stratification factors included world region (United States, Western Europe/Canada/Australia-Pacific, Eastern Europe, Asia, others); prior adjuvant/neoadjuvant therapy (no, yes \[trastuzumab and/or lapatinib\], yes \[no trastuzumab and/or lapatinib\]), and visceral disease (present, absent).||0.95|0.65|
72584691|NCT01120184|144700909|SUPERIORITY_OR_OTHER_LEGACY||Difference in Response Rate|-8.2|||||TWO_SIDED|95.0|-15.9|-0.5|||||Direction of comparison: Trastuzumab Emtansine + Placebo vs Trastuzumab + Taxane|||-0.5|-15.9|
72584692|NCT01120184|144700909|SUPERIORITY_OR_OTHER_LEGACY||Difference in Response Rate|-3.7|||||TWO_SIDED|95.0|-11.4|3.9|||||Direction of comparison: Trastuzumab Emtansine + Pertuzumab vs Trastuzumab + Taxane|||3.9|-11.4|
72584693|NCT01120184|144700909|SUPERIORITY_OR_OTHER_LEGACY||Difference in Response Rate|4.5|||||TWO_SIDED|95.0|-3.3|12.2|||||Direction of comparison: Trastuzumab Emtansine + Pertuzumab vs Trastuzumab Emtansine + Placebo|||12.2|-3.3|
72584694|NCT01120184|144700910|SUPERIORITY_OR_OTHER_LEGACY||Difference in Response Rate|-4.6|||||TWO_SIDED|95.0|-12.1|2.8|||||Direction of comparison: Trastuzumab Emtansine + Placebo vs Trastuzumab + Taxane|||2.8|-12.1|
72584695|NCT01120184|144700910|SUPERIORITY_OR_OTHER_LEGACY||Difference in Response Rate|-1.8|||||TWO_SIDED|95.0|-9.2|5.7|||||Direction of comparison: Trastuzumab Emtansine + Pertuzumab vs Trastuzumab + Taxane|||5.7|-9.2|
72584696|NCT01120184|144700910|SUPERIORITY_OR_OTHER_LEGACY||Difference in Response Rate|2.9|||||TWO_SIDED|95.0|-4.5|10.3|||||Direction of comparison: Trastuzumab Emtansine + Pertuzumab vs Trastuzumab Emtansine + Placebo|||10.3|-4.5|
72584697|NCT01120184|144700911|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.6|||||TWO_SIDED|97.5|0.43|0.84|||||Direction of comparison: Trastuzumab Emtansine + Placebo vs Trastuzumab + Taxane|Stratified Analysis: Stratification factors included world region (United States, Western Europe/Canada/Australia-Pacific, Eastern Europe, Asia, others); prior adjuvant/neoadjuvant therapy (no, yes \[trastuzumab and/or lapatinib\], yes \[no trastuzumab and/or lapatinib\]), and visceral disease (present, absent).||0.84|0.43|
72584698|NCT01120184|144700911|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.62|||||TWO_SIDED|97.5|0.45|0.85|||||Direction of comparison: Trastuzumab Emtansine + Pertuzumab vs Trastuzumab + Taxane|Stratified Analysis: Stratification factors included world region (United States, Western Europe/Canada/Australia-Pacific, Eastern Europe, Asia, others); prior adjuvant/neoadjuvant therapy (no, yes \[trastuzumab and/or lapatinib\], yes \[no trastuzumab and/or lapatinib\]), and visceral disease (present, absent).||0.85|0.45|
72584699|NCT01120184|144700913|SUPERIORITY_OR_OTHER_LEGACY||Difference in Symptom Rate|-32.2|||||TWO_SIDED|95.0|-40.0|-24.0|||||Direction of comparison: Trastuzumab Emtansine + Placebo vs Trastuzumab + Taxane|Stratified Analysis: Stratification factors included world region (United States, Western Europe/Canada/Australia-Pacific, Eastern Europe, Asia, others); prior adjuvant/neoadjuvant therapy (no, yes \[trastuzumab and/or lapatinib\], yes \[no trastuzumab and/or lapatinib\]), and visceral disease (present, absent).||-24|-40|
72584700|NCT01120184|144700913|SUPERIORITY_OR_OTHER_LEGACY||Difference in Symptom Rate|-24.2|||||TWO_SIDED|95.0|-32.0|-16.0|||||Direction of comparison: Trastuzumab Emtansine + Pertuzumab vs Trastuzumab + Taxane|Stratified Analysis: Stratification factors included world region (United States, Western Europe/Canada/Australia-Pacific, Eastern Europe, Asia, others); prior adjuvant/neoadjuvant therapy (no, yes \[trastuzumab and/or lapatinib\], yes \[no trastuzumab and/or lapatinib\]), and visceral disease (present, absent).||-16|-32|
72584701|NCT01120184|144700913|SUPERIORITY_OR_OTHER_LEGACY||Difference in Symptom Rate|8.0|||||TWO_SIDED|95.0|-2.3|18.4|||||Direction of comparison: Trastuzumab Emtansine + Pertuzumab vs Trastuzumab Emtansine + Placebo|Stratified Analysis: Stratification factors included world region (United States, Western Europe/Canada/Australia-Pacific, Eastern Europe, Asia, others); prior adjuvant/neoadjuvant therapy (no, yes \[trastuzumab and/or lapatinib\], yes \[no trastuzumab and/or lapatinib\]), and visceral disease (present, absent).||18.4|-2.3|
72584702|NCT01120184|144700917|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.7|||||TWO_SIDED|95.0|0.57|0.86|||||Direction of comparison: Trastuzumab Emtansine + Placebo vs Trastuzumab + Taxane|Stratified Analysis: Stratification factors included world region (United States, Western Europe/Canada/Australia-Pacific, Eastern Europe, Asia, others); prior adjuvant/neoadjuvant therapy (no, yes \[trastuzumab and/or lapatinib\], yes \[no trastuzumab and/or lapatinib\]), and visceral disease (present, absent).||0.86|0.57|
72584703|NCT01120184|144700917|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.68|||||TWO_SIDED|95.0|0.55|0.84|||||Direction of comparison: Trastuzumab Emtansine + Pertuzumab vs Trastuzumab + Taxane|Stratified Analysis: Stratification factors included world region (United States, Western Europe/Canada/Australia-Pacific, Eastern Europe, Asia, others); prior adjuvant/neoadjuvant therapy (no, yes \[trastuzumab and/or lapatinib\], yes \[no trastuzumab and/or lapatinib\]), and visceral disease (present, absent).||0.84|0.55|
72584704|NCT01120184|144700921|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.67|||||TWO_SIDED|95.0|0.4|1.15|||||Direction of comparison: Trastuzumab Emtansine + Placebo vs Trastuzumab + Taxane|||1.15|0.40|
72413496|NCT02099006|144335833|SUPERIORITY_OR_OTHER|||||||0.42|||||||t-test, 2 sided|Paired||Null hypothesis - that the improvement in tampon test pain would be no different with the daily application of ketoprofen cream than with the daily application of a placebo cream.||||0.42
72584705|NCT01120184|144700922|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.66|||||TWO_SIDED|95.0|0.41|1.07|||||Direction of comparison: Trastuzumab Emtansine + Placebo vs Trastuzumab + Taxane|||1.07|0.41|
72584706|NCT01120184|144700924|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.9|||||TWO_SIDED|97.5|0.65|1.25|||||Direction of comparison: Trastuzumab Emtansine + Placebo vs Trastuzumab + Taxane|||1.25|0.65|
72584707|NCT01120184|144700926|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.0|||||TWO_SIDED|97.5|0.74|1.34|||||Direction of comparison: Trastuzumab Emtansine + Placebo vs Trastuzumab + Taxane|||1.34|0.74|
72584708|NCT04003636|144700931|SUPERIORITY||Hazard Ratio (HR)|0.83||||0.0034|TWO_SIDED|95.0|0.72|0.95|||Regression, Cox|One-sided p-value based on log-rank test stratified by geographic region, disease status, site of origin with small strata collapsed|HR=Arm A/Arm B|||0.95|0.72|0.0034
72584709|NCT04003636|144700932|SUPERIORITY||Hazard Ratio (HR)|0.86||||0.0225|TWO_SIDED|95.0|0.75|1.0|||Regression, Cox|One-sided p-value based on log-rank test stratified by geographic region, disease status, site of origin with small strata collapsed|HR=Arm A/Arm B|||1.00|0.75|0.0225
72584710|NCT04003636|144700933|SUPERIORITY||Difference in Percentages|0.2||||0.4735|TWO_SIDED|95.0|-5.2|5.6||One-sided p-value for testing. H0: difference in % = 0 versus H1: difference in % \> 0|Miettinen & Nurminen||Difference=Arm A minus Arm B|||5.6|-5.2|0.4735
72584711|NCT03656068|144700950|OTHER|Wilcoxon signed-rank test was used for statistical inference.|Median Difference (Net)|0.003||||0.0039|TWO_SIDED|||||p-value for testing median = 0|Sign test|||||||0.0039
72584712|NCT03656068|144700951|OTHER|Wilcoxon signed-rank test was used for statistical inference.|Median Difference (Net)|10.0||||0.0026|TWO_SIDED|||||p-value for testing median = 0|Sign test|||||||0.0026
72584713|NCT03656068|144700952|OTHER|Wilcoxon signed-rank test was used for statistical inference.|Median Difference (Net)|0.002||||0.5555|TWO_SIDED|||||p-value for testing median = 0|Sign test|||||||0.5555
72584714|NCT03656068|144700953|OTHER|Wilcoxon signed-rank test was used for statistical inference.|Median Difference (Net)|1.72||||0.3778|TWO_SIDED|||||p-value for testing median = 0|Sign test|||||||0.3778
72584715|NCT03656068|144700954|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|-8.1||||0.4638|TWO_SIDED|95.0|-31.0|14.8||p-value for testing mean = 0|t-test, 2 sided|||||14.8|-31.0|0.4638
72584716|NCT03656068|144700955|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|-1.65||||0.6532|TWO_SIDED|95.0|-9.26|5.97||p-value for testing mean = 0|t-test, 2 sided|||||5.97|-9.26|0.6532
72584717|NCT03656068|144700956|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|0.38||||0.7254|TWO_SIDED|95.0|-1.86|2.61||p-value for testing mean = 0|t-test, 2 sided|||||2.61|-1.86|0.7254
72584718|NCT03656068|144700957|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|8.77||||0.3772|TWO_SIDED|95.0|-11.7|29.25||p-value for testing mean = 0|t-test, 2 sided|||||29.25|-11.70|0.3772
72584719|NCT03656068|144700958|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|-0.12||||0.5799|TWO_SIDED|95.0|-0.56|0.33||p-value for testing mean = 0|t-test, 2 sided|||||0.33|-0.56|0.5799
72584720|NCT03656068|144700959|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|-1.89||||0.7088|TWO_SIDED|95.0|-12.65|8.87||p-value for testing mean = 0|t-test, 2 sided|||||8.87|-12.65|0.7088
72584721|NCT03656068|144700960|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|-0.35||||0.0609|TWO_SIDED|95.0|-0.72|0.02||p-value for testing mean = 0|t-test, 2 sided|||||0.02|-0.72|0.0609
72584722|NCT03656068|144700961|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|-6.61||||0.1556|TWO_SIDED|95.0|-16.16|2.94||p-value for testing mean = 0|t-test, 2 sided|||||2.94|-16.16|0.1556
72584723|NCT03656068|144700962|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|-14.6||||0.0709|TWO_SIDED|95.0|-30.6|1.4||p-value for testing mean = 0|t-test, 2 sided|||||1.4|-30.6|0.0709
72584724|NCT03656068|144700963|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|-3.61||||0.1799|TWO_SIDED|95.0|-9.02|1.81||p-value for testing mean = 0|t-test, 2 sided|||||1.81|-9.02|0.1799
72584725|NCT03656068|144700964|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|-6.8||||0.3306|TWO_SIDED|95.0|-21.2|7.6||p-value for testing mean = 0|t-test, 2 sided|||||7.6|-21.2|0.3306
72584726|NCT03656068|144700965|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|-1.94||||0.4504|TWO_SIDED|95.0|-7.25|3.37||p-value for testing mean = 0|t-test, 2 sided|||||3.37|-7.25|0.4504
72584727|NCT03656068|144700966|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|33.8||||0.1349|TWO_SIDED|95.0|-11.5|79.0||p-value for testing mean = 0|t-test, 2 sided|||||79.0|-11.5|0.1349
72584728|NCT03656068|144700967|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|76.24||||0.0117|TWO_SIDED|95.0|19.04|133.43||p-value for testing mean = 0|t-test, 2 sided|||||133.43|19.04|0.0117
72584729|NCT03656068|144700968|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|31.3||||0.4281|TWO_SIDED|95.0|-50.3|112.9||p-value for testing mean = 0|t-test, 2 sided|||||112.9|-50.3|0.4281
72584730|NCT03656068|144700969|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|117.37||||0.0407|TWO_SIDED|95.0|5.6|229.14||p-value for testing mean = 0|t-test, 2 sided|||||229.14|5.60|0.0407
72584731|NCT03656068|144700970|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|47.28||||0.7065|TWO_SIDED|95.0|-210.9|305.46||p-value for testing mean = 0|t-test, 2 sided|||||305.46|-210.90|0.7065
72584732|NCT03656068|144700971|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|43.11||||0.1693|TWO_SIDED|95.0|-19.95|106.17||p-value for testing mean = 0|t-test, 2 sided|||||106.17|-19.95|0.1693
72584733|NCT03656068|144700972|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|-48.14||||0.7099|TWO_SIDED|95.0|-317.64|221.36||p-value for testing mean = 0|t-test, 2 sided|||||221.36|-317.64|0.7099
72584734|NCT03656068|144700973|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|30.03||||0.3597|TWO_SIDED|95.0|-37.48|97.55||p-value for testing mean = 0|t-test, 2 sided|||||97.55|-37.48|0.3597
72584735|NCT03656068|144700974|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|169.0||||0.9893|TWO_SIDED|95.0|-25908.2|26246.2||p-value for testing mean = 0|t-test, 2 sided|||||26246.2|-25908.2|0.9893
72584736|NCT03656068|144700975|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|13.82||||0.1454|TWO_SIDED|95.0|-5.21|32.85||p-value for testing mean = 0|t-test, 2 sided|||||32.85|-5.21|0.1454
72584737|NCT03656068|144700976|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|3016.8||||0.8089|TWO_SIDED|95.0|-22996.2|29029.7||p-value for testing mean = 0|t-test, 2 sided|||||29029.7|-22996.2|0.8089
72584738|NCT03656068|144700977|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|12.78||||0.1365|TWO_SIDED|95.0|-4.5|30.06||p-value for testing mean = 0|t-test, 2 sided|||||30.06|-4.50|0.1365
72584739|NCT03656068|144700978|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|28.954||||0.1322|TWO_SIDED|95.0|-9.525|67.433||p-value for testing mean = 0|t-test, 2 sided|||||67.433|-9.525|0.1322
72584740|NCT03656068|144700979|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|23.99||||0.1062|TWO_SIDED|95.0|-5.59|53.57|||t-test, 2 sided|p-value for testing mean = 0||||53.57|-5.59|0.1062
72413497|NCT02099006|144335833|SUPERIORITY_OR_OTHER|||||||0.79|||||||t-test, 2 sided|Paired||Null hypothesis - that the improvement in tampon test pain would be no different with the daily application of amitriptyline/baclofen cream than with the daily application of a placebo cream.||||0.79
72413498|NCT01410448|144335846|SUPERIORITY_OR_OTHER|||||||0.0921|||||||Regression, Logistic|||||||0.0921
72413499|NCT01308580|144335863|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin of 1.214|Hazard Ratio (HR)|1.024|||||ONE_SIDED|98.89||1.184|||||Cabazitaxel 20 mg/m\^2 vs Cabazitaxel 25 mg/m\^2|The hazard ratio for OS was estimated using the Cox proportional hazards regression model. The Cox proportional hazard model was adjusted by measurability of the disease at baseline, ECOG PS score at baseline, and region at the time of randomization. Cabazitaxel 20 mg/m\^2 relative to 25 mg/m\^2 dose group was considered non-inferior if the upper bound of 1-sided 98.89% confidence interval of hazard ratio (20 mg/m\^2 versus 25 mg/m\^2) was less than the non-inferiority margin of 1.214.||1.184||
72413500|NCT01308580|144335863|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.024|||||ONE_SIDED|95.0|0.922||||||Cabazitaxel 20 mg/m\^2 vs Cabazitaxel 25 mg/m\^2|The hazard ratio for OS was estimated using the Cox proportional hazards regression model. The Cox proportional hazard model was adjusted by measurability of the disease at baseline, ECOG PS score at baseline, and region at the time of randomization. Cabazitaxel 25 mg/m\^2 was considered to be superior to 20 mg/m\^2 dose if the lower bound of 1-sided 95% confidence interval of hazard ratio was greater than 1.|||0.922|
72413501|NCT01308580|144335864|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.099|||||TWO_SIDED|95.0|0.974|1.24|||||Cabazitaxel 20 mg/m\^2 vs Cabazitaxel 25 mg/m\^2|Hazard ratio was estimated using a Cox Proportional Hazards regression model. The Cox proportional hazard model was adjusted by measurability of the disease at baseline, ECOG PS score at baseline, and region at the time of randomization.||1.24|0.974|
72413502|NCT01308580|144335865|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.096|||||TWO_SIDED|95.0|0.902|1.331|||||Cabazitaxel 20 mg/m\^2 vs Cabazitaxel 25 mg/m\^2|Hazard ratio was estimated using a Cox Proportional Hazards regression model. The Cox proportional hazard model was adjusted by measurability of the disease at baseline, ECOG PS score at baseline, and region at the time of randomization.||1.331|0.902|
72584741|NCT03656068|144700980|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|28.311||||0.0831|TWO_SIDED|95.0|-4.151|60.774||p-value for testing mean = 0|t-test, 2 sided|||||60.774|-4.151|0.0831
72584742|NCT03656068|144700981|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|32.72||||0.0543|TWO_SIDED|95.0|-0.69|66.13||p-value for testing mean = 0|t-test, 2 sided|||||66.13|-0.69|0.0543
72584743|NCT03656068|144700982|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|0.056||||0.6325|TWO_SIDED|95.0|-0.185|0.298||p-value for testing mean = 0|t-test, 2 sided|||||0.298|-0.185|0.6325
72584744|NCT03656068|144700983|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|0.46||||0.6925|TWO_SIDED|95.0|-1.94|2.87||p-value for testing mean = 0|t-test, 2 sided|||||2.87|-1.94|0.6925
72584745|NCT03656068|144700984|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|0.161||||0.2733|TWO_SIDED|95.0|-0.14|0.462|||t-test, 2 sided|||||0.462|-0.140|0.2733
72584746|NCT03656068|144700985|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|1.47||||0.3288|TWO_SIDED|95.0|-1.63|4.56||p-value for testing mean = 0|t-test, 2 sided|||||4.56|-1.63|0.3288
72413503|NCT01308580|144335867|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.195|||||TWO_SIDED|95.0|1.025|1.393|||||Cabazitaxel 20 mg/m\^2 vs Cabazitaxel 25 mg/m\^2|Hazard ratio was estimated using a Cox Proportional Hazards regression model. The Cox proportional hazard model was adjusted by measurability of the disease at baseline, ECOG PS score at baseline, and region at the time of randomization.||1.393|1.025|
72413504|NCT01308580|144335869|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.046|||||TWO_SIDED|95.0|0.874|1.251|||||Cabazitaxel 20 mg/m\^2 vs Cabazitaxel 25 mg/m\^2|Hazard ratio is estimated using a Cox Proportional Hazards regression model. The Cox proportional hazard model was adjusted by measurability of the disease at baseline, ECOG PS score at baseline, and region at the time of randomization.||1.251|0.874|
72413505|NCT00360529|144335881|SUPERIORITY_OR_OTHER|||||||0.0454||95.0||||Hierarchical ordering used for multiple endpoints, and Hochberg used for multiple dose comparisons. P-values ordered (p1≤p2). If p2≤0.05 then all doses significant. If p1≤0.025 then reject null for p1|Wilcoxon (Mann-Whitney)|||Flibanserin 50 mg qhs versus placebo||||0.0454
72584747|NCT03656068|144700986|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|5.649||||0.9271|TWO_SIDED|95.0|-121.923|133.22||p-value for testing mean = 0|t-test, 2 sided|||||133.220|-121.923|0.9271
72584748|NCT03656068|144700987|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|0.89||||0.9244|TWO_SIDED|95.0|-18.58|20.37||p-value for testing mean = 0|t-test, 2 sided|||||20.37|-18.58|0.9244
72584749|NCT03656068|144700988|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|-30.244||||0.7288|TWO_SIDED|95.0|-211.93|151.441||p-value for testing mean = 0|t-test, 2 sided|||||151.441|-211.930|0.7288
72584750|NCT03656068|144700989|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|3.34||||0.7824|TWO_SIDED|95.0|-21.85|28.52||p-value for testing mean = 0|t-test, 2 sided|||||28.52|-21.85|0.7824
72584751|NCT03656068|144700990|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|-47.629||||0.6448|TWO_SIDED|95.0|-260.433|165.176||p-value for testing mean = 0|t-test, 2 sided|||||165.176|-260.433|0.6448
72584752|NCT03656068|144700991|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|0.38||||0.9806|TWO_SIDED|95.0|-32.04|32.8||p-value for testing mean = 0|t-test, 2 sided|||||32.80|-32.04|0.9806
72584753|NCT03656068|144700992|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|-113.616||||0.3256|TWO_SIDED|95.0|-351.124|123.891||p-value for testing mean = 0|t-test, 2 sided|||||123.891|-351.124|0.3256
72584754|NCT03656068|144700993|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|8.78||||0.6582|TWO_SIDED|95.0|-32.52|50.09||p-value for testing mean = 0|t-test, 2 sided|||||50.09|-32.52|0.6582
72584755|NCT03656068|144700994|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|-0.2438||||0.5459|TWO_SIDED|95.0|-1.0847|0.5972||p-value for testing mean = 0|t-test, 2 sided|||||0.5972|-1.0847|0.5459
72413506|NCT00360529|144335881|SUPERIORITY_OR_OTHER|||||||0.0024||95.0||||Hierarchical ordering used for multiple endpoints, and Hochberg used for multiple dose comparisons. P-values ordered (p1≤p2). If p2≤0.05 then all doses significant. If p1≤0.025 then reject null for p1|Wilcoxon (Mann-Whitney)|||Flibanserin 100 mg qhs versus placebo||||0.0024
72584756|NCT03656068|144700995|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|23.91||||0.286|TWO_SIDED|95.0|-22.15|69.97|||t-test, 2 sided|||||69.97|-22.15|0.2860
72584757|NCT03656068|144700996|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|-0.2893||||0.4887|TWO_SIDED|95.0|-1.158|0.5794||p-value for testing mean = 0|t-test, 2 sided|||||0.5794|-1.1580|0.4887
72584758|NCT03656068|144700997|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|30.27||||0.361|TWO_SIDED|95.0|-38.21|98.75||p-value for testing mean = 0|t-test, 2 sided|||||98.75|-38.21|0.3610
72584759|NCT03656068|144700998|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|-0.63||||0.4945|TWO_SIDED|95.0|-2.51|1.26||p-value for testing mean = 0|t-test, 2 sided|||||1.26|-2.51|0.4945
72584760|NCT03656068|144700999|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|-0.99||||0.8191|TWO_SIDED|95.0|-9.94|7.95||p-value for testing mean = 0|t-test, 2 sided|||||7.95|-9.94|0.8191
72584761|NCT03656068|144701000|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|-3.22||||0.0243|TWO_SIDED|95.0|-5.96|-0.47||p-value for testing mean = 0|t-test, 2 sided|||||-0.47|-5.96|0.0243
72584762|NCT03656068|144701001|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|-9.94||||0.0493|TWO_SIDED|95.0|-19.84|-0.04||p-value for testing mean = 0|t-test, 2 sided|||||-0.04|-19.84|0.0493
72584763|NCT03656068|144701002|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|0.6||||0.3066|TWO_SIDED|95.0|-0.59|1.79||p-value for testing mean = 0|t-test, 2 sided|||||1.79|-0.59|0.3066
72584764|NCT03656068|144701003|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|3.4||||0.2671|TWO_SIDED|95.0|-2.82|9.63||p-value for testing mean = 0|t-test, 2 sided|||||9.63|-2.82|0.2671
72584765|NCT03656068|144701004|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|0.11||||0.8241|TWO_SIDED|95.0|-0.94|1.16||p-value for testing mean = 0|t-test, 2 sided|||||1.16|-0.94|0.8241
72584766|NCT03656068|144701005|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|1.1||||0.7587|TWO_SIDED|95.0|-6.37|8.57||p-value for testing mean = 0|t-test, 2 sided|||||8.57|-6.37|0.7587
72413507|NCT00360529|144335882|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.3||||0.2606||95.0|-1.0|3.7||Hierarchical ordering used for multiple endpoints, and Hochberg used for multiple dose comparisons. P-values ordered (p1≤p2). If p2≤0.05 then all doses significant. If p1≤0.025 then reject null for p1|ANCOVA|Model includes treatment, centre and baseline as a covariate||Flibanserin 50 mg qhs versus placebo||3.7|-1.0|0.2606
72584767|NCT03656068|144701006|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|-0.567||||0.3784|TWO_SIDED|95.0|-1.88|0.746||p-value for testing mean = 0|t-test, 2 sided|||||0.746|-1.880|0.3784
72584768|NCT03656068|144701007|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|-4.64||||0.3526|TWO_SIDED|95.0|-14.8|5.53||p-value for testing mean = 0|t-test, 2 sided|||||5.53|-14.80|0.3526
72584769|NCT03656068|144701008|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|0.098||||0.9218|TWO_SIDED|95.0|-1.978|2.173||p-value for testing mean = 0|t-test, 2 sided|||||2.173|-1.978|0.9218
72584770|NCT03656068|144701009|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|0.15||||0.9833|TWO_SIDED|95.0|-14.71|15.01||p-value for testing mean = 0|t-test, 2 sided|||||15.01|-14.71|0.9833
72584771|NCT03656068|144701010|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|12.68||||0.3957|TWO_SIDED|95.0|-17.79|43.16||p-value for testing mean = 0|t-test, 2 sided|||||43.16|-17.79|0.3957
72584772|NCT03656068|144701011|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|3.81||||0.344|TWO_SIDED|95.0|-4.39|12.01||p-value for testing mean = 0|t-test, 2 sided|||||12.01|-4.39|0.3440
72584773|NCT03656068|144701012|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|15.22||||0.0607|TWO_SIDED|95.0|-0.77|31.21||p-value for testing mean = 0|t-test, 2 sided|||||31.21|-0.77|0.0607
72584774|NCT03656068|144701013|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|5.83||||0.0644|TWO_SIDED|95.0|-0.39|12.05||p-value for testing mean = 0|t-test, 2 sided|||||12.05|-0.39|0.0644
72584775|NCT03656068|144701014|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|-0.3665||||0.0487|TWO_SIDED|95.0|-0.7306|-0.0023||p-value for testing mean = 0|t-test, 2 sided|||||-0.0023|-0.7306|0.0487
72584776|NCT03656068|144701015|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|16.64||||0.5919|TWO_SIDED|95.0|-47.25|80.54||p-value for testing mean = 0|t-test, 2 sided|||||80.54|-47.25|0.5919
72584777|NCT03656068|144701016|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|-0.2679||||0.1272|TWO_SIDED|95.0|-0.634|0.0983||p-value for testing mean = 0|t-test, 2 sided|||||0.0983|-0.6340|0.1272
72584778|NCT03656068|144701017|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|15.02||||0.5881|TWO_SIDED|95.0|-47.55|77.59||p-value for testing mean = 0|t-test, 2 sided|||||77.59|-47.55|0.5881
72584779|NCT03656068|144701018|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|-0.18||||0.1458|TWO_SIDED|95.0|-0.42|0.07|||t-test, 2 sided|||||0.07|-0.42|0.1458
72584780|NCT03656068|144701019|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|-11.53||||0.1495|TWO_SIDED|95.0|-27.61|4.54||p-value for testing mean = 0|t-test, 2 sided|||||4.54|-27.61|0.1495
72584781|NCT03656068|144701020|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|-0.12||||0.3174|TWO_SIDED|95.0|-0.4|0.15||p-value for testing mean = 0|t-test, 2 sided|||||0.15|-0.40|0.3174
72584782|NCT03656068|144701021|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|-8.02||||0.242|TWO_SIDED|95.0|-22.86|6.82||p-value for testing mean = 0|t-test, 2 sided|||||6.82|-22.86|0.2420
72584783|NCT00162981|144701025|SUPERIORITY_OR_OTHER||||||<|0.0182||95.0|||||1-sided Wilcoxon signed rank test|1-sided Wilcoxon signed rank test was used to assess the difference from baseline.||||||<0.0182
72584784|NCT00162981|144701025|SUPERIORITY_OR_OTHER|||||||0.0001||95.0||||1-sided Wilcoxon signed rank test was used to assess the difference from baseline.|1-sided Wilcoxon signed rank test|||||||0.0001
72584785|NCT00162981|144701028|NON_INFERIORITY_OR_EQUIVALENCE|Assuming a standard deviation of 50%, one-tailed significance at 0.05 and a power of 80% to detect a reduction of at least 25% (baseline to final in a within-subjects design), then approximately 27 subjects would have been required in each treatment arm. Assuming a 10% drop-out rate, then approximately 30 subjects per treatment were to be enrolled in the study.|||||<|0.0001||95.0|||||1-sided Wilcoxon Rank-Sum Test|1-sided Wilcoxon Rank-Sum Test was used to compare the high dose group to the low dose group.||||||<0.0001
72584786|NCT00300235|144701034|SUPERIORITY_OR_OTHER||proportion of subjects|35.2||||||95.0|32.5|37.9||||||This was a survey designed to estimate prevalence, no formal comparisons between age or genotype groups were performed.||37.9|32.5|
72584787|NCT00455403|144701038|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.01||||0.7279|TWO_SIDED|||||"Applies to row Title year 1"|Mixed Models Analysis||"applies to row title year 1"|||||0.7279
72584788|NCT00502242|144701127|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.228||||0.0002|TWO_SIDED|95.0|0.099|0.528||2-sided p-value; alpha equals (=) 0.05|Log Rank|Stratified log-rank test with region and race strata|Stratified Cox proportional hazard model with region and race strata|||0.528|0.099|0.0002
72584789|NCT00502242|144701128|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.425||||0.0031|TWO_SIDED|95.0|0.237|0.763||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|Log Rank|Stratified log-rank test with region and race strata|Stratified Cox proportional hazard model with region and race strata|||0.763|0.237|0.0031
72584790|NCT00502242|144701129|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|Fisher Exact|||Up to 24 weeks post-conversion||||0.002
72584791|NCT00502242|144701129|SUPERIORITY_OR_OTHER|||||||0.074|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|Fisher Exact|||Up to 52 weeks post-conversion||||0.074
72413508|NCT00360529|144335882|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.2||||0.066||95.0|-0.1|4.6|||ANCOVA|Model includes treatment, centre and baseline as a covariate||Flibanserin 100 mg qhs versus placebo||4.6|-0.1|0.066
72584792|NCT00502242|144701130|SUPERIORITY_OR_OTHER|||||||0.093|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|Fisher Exact|||Up to 24 weeks post-conversion||||0.093
72584793|NCT00502242|144701130|SUPERIORITY_OR_OTHER|||||||0.219|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|Fisher Exact|||Up to 52 weeks post-conversion||||0.219
72584794|NCT00502242|144701131|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|Fisher Exact|||Up to 24 weeks post-conversion||||0.002
72584795|NCT00502242|144701131|SUPERIORITY_OR_OTHER|||||||0.121|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|Fisher Exact|||Up to 52 weeks post-conversion||||0.121
72584796|NCT00502242|144701132|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Fold Change|1.16|||||TWO_SIDED||||||||Adjusted for baseline|Change from Baseline at Week 3, Ramipril||||
72584797|NCT00502242|144701132|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Fold Change|1.36|||||TWO_SIDED||||||||Adjusted for baseline|Change from Baseline at Week 3, Placebo||||
72584798|NCT00502242|144701132|SUPERIORITY_OR_OTHER||Treatment Ratio|0.85||||0.0098|TWO_SIDED|95.0|0.76|0.96||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|ANCOVA|ANCOVA model with change in the logarithmic Up/c as dependent variable, treatment and region/race as factors, and logarithmic baseline as covariate.|Treatment ratio (Ramipril/Placebo) in the geometric mean fold-change.|Change from baseline at Week 3, Ramipril versus (vs.) Placebo||0.96|0.76|0.0098
72584799|NCT00502242|144701132|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Fold Change|1.18|||||TWO_SIDED||||||||Adjusted for baseline|Change from baseline at Week 4, Ramipril||||
72584800|NCT00502242|144701132|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Fold Change|1.52|||||TWO_SIDED||||||||Adjusted for baseline|Change from baseline at Week 4, Placebo||||
72584801|NCT00502242|144701132|SUPERIORITY_OR_OTHER||Treatment Ratio|0.78||||0.0003|TWO_SIDED|95.0|0.68|0.89||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|ANCOVA|ANCOVA model with change in the logarithmic Up/c as dependent variable, treatment and region/race as factors, and logarithmic baseline as covariate.|Treatment ratio (Ramipril/Placebo) in the geometric mean fold-change.|Change from baseline at Week 4, Ramipril vs. Placebo||0.89|0.68|0.0003
72584802|NCT00502242|144701132|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Fold Change|1.27|||||TWO_SIDED||||||||Adjusted for baseline|Change from baseline at Week 8, Ramipirl||||
72584803|NCT00502242|144701132|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Fold Change|1.61|||||TWO_SIDED||||||||Adjusted for baseline|Change from baseline at Week 8, Placebo||||
72584804|NCT00502242|144701132|SUPERIORITY_OR_OTHER||Treatment Ratio|0.79||||0.0016|TWO_SIDED|95.0|0.68|0.91||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|ANCOVA|ANCOVA model with change in the logarithmic Up/c as dependent variable, treatment and region/race as factors, and logarithmic baseline as covariate.|Treatment ratio (Ramipril/Placebo) in the geometric mean fold-change.|Change from Baseline at Week 8, Ramipril vs. Placebo||0.91|0.68|0.0016
72584805|NCT00502242|144701132|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Fold Change|1.34|||||TWO_SIDED||||||||Adjusted for baseline|Change from Baseline at Week 12, Ramipril||||
72584806|NCT00502242|144701132|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Fold Change|1.63|||||TWO_SIDED||||||||Adjusted for baseline|Change from Baseline at Week 12, Placebo||||
72584807|NCT00502242|144701132|SUPERIORITY_OR_OTHER||Treatment Ratio|0.82||||0.0165|TWO_SIDED|95.0|0.7|0.96||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|ANCOVA|ANCOVA model with change in the logarithmic Up/c as dependent variable, treatment and region/race as factors, and logarithmic baseline as covariate.|Treatment ratio (Ramipril/Placebo) in the geometric mean fold-change.|Change from Baseline at Week 12, Ramipril vs. Placebo||0.96|0.70|0.0165
72584808|NCT00502242|144701132|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Fold Change|1.48|||||TWO_SIDED||||||||Adjusted for baseline|Change from Baseline at Week 24, Ramipril||||
72584809|NCT00502242|144701132|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Fold Change|1.78|||||TWO_SIDED||||||||Adjusted for baseline|Change from Baseline at Week 24, Placebo||||
72584810|NCT00502242|144701132|SUPERIORITY_OR_OTHER||Treatment Ratio|0.83||||0.0264|TWO_SIDED|95.0|0.7|0.98||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|ANCOVA|ANCOVA model with change in the logarithmic Up/c as dependent variable, treatment and region/race as factors, and logarithmic baseline as covariate.|Treatment ratio (Ramipril/Placebo) in the geometric mean fold-change.|Change from Baseline at Week 24, Ramipril vs. Placebo||0.98|0.70|0.0264
72413509|NCT00360529|144335883|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.2||||0.1601||95.0|-2.9|0.5||Hierarchical ordering used for multiple endpoints, and Hochberg used for multiple dose comparisons. P-values ordered (p1≤p2). If p2≤0.05 then all doses significant. If p1≤0.025 then reject null for p1|ANCOVA|Model includes treatment, centre and baseline as a covariate||Flibanserin 50 mg qhs versus placebo||0.5|-2.9|0.1601
72413510|NCT00360529|144335883|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.9||||0.0001||95.0|-5.6|-2.2||Hierarchical ordering used for multiple endpoints, and Hochberg used for multiple dose comparisons. P-values ordered (p1≤p2). If p2≤0.05 then all doses significant. If p1≤0.025 then reject null for p1|ANCOVA|Model includes treatment, centre and baseline as a covariate||Flibanserin 100 mg qhs versus placebo||-2.2|-5.6|0.0001
72413511|NCT00360529|144335884|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.1144||95.0|-0.3|0.0||Hierarchical ordering used for multiple endpoints, and Hochberg used for multiple dose comparisons. P-values ordered (p1≤p2). If p2≤0.05 then all doses significant. If p1≤0.025 then reject null for p1|ANCOVA|Model includes treatment, centre and baseline as a covariate||Flibanserin 50 mg qhs versus placebo||0.0|-0.3|0.1144
72552188|NCT00048581|144635016|SUPERIORITY_OR_OTHER||Est. of Diff: Day 113 ACR 70|7.8||||0.002|TWO_SIDED|95.0|2.6|13.0|||Cochran-Mantel-Haenszel|All statistical tests and CI were 2-sided. Percentage of participants with response compared by estimate of weighted difference (Est of Weighted Diff)|Differences in ACR response between the two treatment groups represent the weighted average of the individual stratum differences.|If ACR20 comparison was significant (5% level), then CMH Chi-square test compared ACR 70 response between groups (5% level). If the ACR20 analysis was not significant (5% level), then the comparison for ACR 70 response was not undertaken. A 2-sided Cochran-Mantel-Haenszel (CMH) Chi-square test was used to compare these two treatment groups at the .05 level of significance, with stratification based on baseline history of anti-TNF status (current or prior use).||13.0|2.6|0.002
72584811|NCT00502242|144701132|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Fold Change|1.43|||||TWO_SIDED||||||||Adjusted for baseline|Change from Baseline at Week 30, Ramipril||||
72584812|NCT00502242|144701132|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Fold Change|1.82|||||TWO_SIDED||||||||Adjusted for baseline|Change from Baseline at Week 30, Placebo||||
72584813|NCT00502242|144701132|SUPERIORITY_OR_OTHER||Treatment Ratio|0.79||||0.0062|TWO_SIDED|95.0|0.66|0.93||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|ANCOVA|ANCOVA model with change in the logarithmic Up/c as dependent variable, treatment and region/race as factors, and logarithmic baseline as covariate.|Treatment ratio (Ramipril/Placebo) in the geometric mean fold-change.|Change from Baseline at Week 30, Ramipril vs. Placebo||0.93|0.66|0.0062
72584814|NCT00502242|144701132|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Fold Change|1.4|||||TWO_SIDED||||||||Adjusted for baseline|Change from Baseline at Week 36, Ramipril||||
72552189|NCT00048581|144635016|SUPERIORITY_OR_OTHER||Est. of Diff: Day 141 ACR 20|35.5|||<|0.001|TWO_SIDED|95.0|24.6|46.5|||Cochran-Mantel-Haenszel|All statistical tests and CI were 2-sided. Percentage of participants with response compared by estimate of difference (Est of Diff)|Differences in ACR response between the two treatment groups represent the weighted average of the individual stratum differences.|Differences in ACR 20 between the treatment arm receiving ABA plus background DMARDs and the treatment arm receiving PLA plus background DMARDs were compared using a 2-sided Cochran-Mantel-Haenszel (CMH) Chi-square test (.05 level of significance), with stratification based on baseline history of anti-TNF status (current or prior use).||46.5|24.6|<0.001
72584815|NCT00502242|144701132|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Fold Change|1.67|||||TWO_SIDED||||||||Adjusted for baseline|Change from Baseline at Week 36, Placebo||||
72584816|NCT00502242|144701132|SUPERIORITY_OR_OTHER||Treatment Ratio|0.84||||0.0341|TWO_SIDED|95.0|0.72|0.99||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|ANCOVA|ANCOVA model with change in the logarithmic Up/c as dependent variable, treatment and region/race as factors, and logarithmic baseline as covariate.|Treatment ratio (Ramipril/Placebo) in the geometric mean fold-change.|Change from Baseline at Week 36, Ramipril vs. Placebo||0.99|0.72|0.0341
72584817|NCT00502242|144701132|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Fold Change|1.56|||||TWO_SIDED||||||||Adjusted for baseline|Change from Baseline at Week 52, Ramipril||||
72584818|NCT00502242|144701132|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Fold Change|1.86|||||TWO_SIDED||||||||Adjusted for baseline|Change from Baseline at Week 52, Placebo||||
72584819|NCT00502242|144701132|SUPERIORITY_OR_OTHER||Treatment Ratio|0.84||||0.06|TWO_SIDED|95.0|0.7|1.01||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|ANCOVA|ANCOVA model with change in the logarithmic Up/c as dependent variable, treatment and region/race as factors, and logarithmic baseline as covariate.|Treatment ratio (Ramipril/Placebo) in the geometric mean fold-change.|Change from Baseline at Week 52, Ramipril vs. Placebo||1.01|0.70|0.0600
72584820|NCT00502242|144701133|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Fold Change|1.46|||||TWO_SIDED||||||||Adjusted for baseline|Change from Baseline at Week 3, Ramipril||||
72584821|NCT00502242|144701133|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Fold Change|2.05|||||TWO_SIDED||||||||Adjusted for baseline|Change from Baseline at Week 3, Placebo||||
72413512|NCT00360529|144335884|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4||||0.0001||95.0|-0.5|-0.2||Hierarchical ordering used for multiple endpoints, and Hochberg used for multiple dose comparisons. P-values ordered (p1≤p2). If p2≤0.05 then all doses significant. If p1≤0.025 then reject null for p1|ANCOVA|Model includes treatment, centre and baseline as a covariate||Flibanserin 100 mg qhs versus placebo||-0.2|-0.5|0.0001
72584822|NCT00502242|144701133|SUPERIORITY_OR_OTHER||Treatment Ratio|0.71||||0.0034|TWO_SIDED|95.0|0.57|0.89||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|ANCOVA|ANCOVA model with change in the logarithmic U alb/c as dependent variable, treatment and region/race as factors, and logarithmic baseline as covariate|Treatment ratio (Ramipril/Placebo) in the geometric mean fold-change.|Change from Baseline at Week 3, Ramipril vs. Placebo||0.89|0.57|0.0034
72584823|NCT00502242|144701133|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Fold Change|1.43|||||TWO_SIDED||||||||Adjusted for baseline|Change from Baseline at Week 4, Ramipril||||
72584824|NCT00502242|144701133|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Fold Change|2.37|||||TWO_SIDED||||||||Adjusted for baseline|Change from Baseline at Week 4, Placebo||||
72413513|NCT00360529|144335885|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2||||0.0173||95.0|0.0|0.4|||ANCOVA|Model includes treatment, centre and baseline as a covariate||Flibanserin 50 mg qhs versus placebo||0.4|0.0|0.0173
72413514|NCT00360529|144335885|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.4||||0.0001||95.0|0.2|0.5|||ANCOVA|Model includes treatment, centre and baseline as a covariate||Flibanserin 100 mg qhs versus placebo||0.5|0.2|0.0001
72413515|NCT00360529|144335886|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.5||||0.0071||95.0|0.4|2.6|||ANCOVA|Model includes treatment, centre and baseline as a covariate||Flibanserin 50 mg qhs versus placebo||2.6|0.4|0.0071
72413516|NCT00360529|144335886|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.5||||0.0001||95.0|1.4|3.6|||ANCOVA|Model includes treatment, centre and baseline as a covariate||Flibanserin 100 mg qhs versus placebo||3.6|1.4|0.0001
72413517|NCT00360529|144335887|SUPERIORITY_OR_OTHER||Percentage responders|34.7||||0.0513||95.0|29.0|40.4|||Cochran-Mantel-Haenszel|Model includes treatment and centre||Flibanserin 25 mg bid versus placebo||40.4|29.0|0.0513
72413518|NCT00360529|144335887|SUPERIORITY_OR_OTHER||Percentage responders|38.6||||0.0059||95.0|32.6|44.6|||Cochran-Mantel-Haenszel|Model includes treatment and centre||Flibanserin 50 mg qhs versus placebo||44.6|32.6|0.0059
72413519|NCT01218438|144335890|SUPERIORITY_OR_OTHER_LEGACY||Poisson|0.012|||<|0.0001|ONE_SIDED|99.0||0.024|||Poisson|||||0.024||<0.0001
72413520|NCT05732454|144335991|SUPERIORITY||Difference in percentage|-3.76|||=|0.558|TWO_SIDED|95.0|-16.36|8.83|||Cochran-Mantel-Haenszel|||Normal approximation adjusting for the stratification factor (disease severity as measured by baseline IGA score 3 \[moderate\], 4 \[severe\]) derived from clinical database via Cochran-Mantel-Haenszel (CMH) approach was used.||8.83|-16.36|=0.5580
72413521|NCT05732454|144335992|SUPERIORITY||Difference in percentage|9.07|||=|0.3685|TWO_SIDED|95.0|-10.7|28.85|||Cochran-Mantel-Haenszel|||Normal approximation adjusting for the stratification factor (disease severity as measured by baseline IGA score 3 \[moderate\], 4 \[severe\]) derived from clinical database via Cochran-Mantel-Haenszel (CMH) approach was used.||28.85|-10.70|=0.3685
72413522|NCT05732454|144335993|SUPERIORITY||Difference in Mean|-29.22|||=|0.0303|TWO_SIDED|95.0|-55.53|-2.9|||Rubin's rule|||Jump-to-Control (JTC) method was used for evaluation. A complete imputed dataset was analyzed using analysis of covariance model including effects of treatment group, actual stratification factor, and baseline value. Multiple results of the treatment comparison were combined using Rubin's rules, reporting the combined treatment difference, its standard error, 95% CI and 2-sided p-value, across the visits.||-2.90|-55.53|=0.0303
72413523|NCT01262651|144336019|SUPERIORITY||Median Difference (Final Values)|3.41||||0.0854|TWO_SIDED|95.0|0.0|8.16|||Wilcoxon (Mann-Whitney)|||||8.16|0.00|0.0854
72413524|NCT00377819|144336038|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin = -0.35%|Mean Difference (Final Values)|0.85|||<|0.0001||95.0|0.44|1.25|||Repeated Measures Model||Based on repeated measures model adjusting for treatment, length of prior alendronate stratification variable, visit, baseline value, machine type, treatment by visit interaction, and baseline value by machine type interaction|||1.25|0.44|<0.0001
72584825|NCT00502242|144701133|SUPERIORITY_OR_OTHER||Treatment Ratio|0.6|||<|0.0001|TWO_SIDED|95.0|0.47|0.76||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|ANCOVA|ANCOVA model with change in the logarithmic U alb/c as dependent variable, treatment and region/race as factors, and logarithmic baseline as covariate|Treatment ratio (Ramipril/Placebo) in the geometric mean fold-change.|Change from Baseline at Week 4, Ramipril vs. Placebo||0.76|0.47|<0.0001
72584826|NCT00502242|144701133|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Fold Change|1.67|||||TWO_SIDED||||||||Adjusted for baseline|Change from Baseline at Week 8, Ramipril||||
72413525|NCT00377819|144336039|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin = -0.22%|Mean Difference (Final Values)|1.18|||<|0.0001||95.0|0.63|1.73|||Repeated Measures Model||Based on repeated measures model adjusting for treatment, length of prior alendronate stratification variable, visit, baseline value, machine type, treatment by visit interaction, and baseline value by machine type interaction|||1.73|0.63|<0.0001
72413526|NCT00377819|144336040|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Van Elteren Stratified Rank Test|||||||<0.0001
72413527|NCT01914926|144336096|NON_INFERIORITY_OR_EQUIVALENCE|Chi-Square test||||||0.0001||95.0|||||Chi-squared|||We estimated a sample size of 200 patients assigned in a 1:1 ratio to receive diltiazem and metoprolol would achieve 80% power to detect non-inferiority using a one-sided two sample t-test. The margin of equivalence is -10.||||.0001
72413528|NCT00321919|144336132|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.778976||||0.2036|TWO_SIDED|95.0|0.53|1.14|||Regression, Cox||The Cox regression model was used to estimate the relative risk of the time to first cardiovascular event in Late Epoetin beta therapy group compared to the Early Epoetin beta therapy group.|The null hypothesis stated that there was no difference with regard to the event-free distribution of the combined endpoint of all protocol specified cardiovascular events between Early Epoetin beta therapy and Late Epoetin beta therapy groups.||1.14|0.53|0.2036
72413529|NCT00321919|144336133|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.744575||||0.4833|TWO_SIDED|95.0|0.33|1.7|||Regression, Cox||The Cox regression model was used to estimate the relative risk of an event of the time to death due to cardiovascular reasons in Late Epoetin beta therapy group compared to the Early Epoetin beta therapy group.|||1.70|0.33|0.4833
72413530|NCT00321919|144336135|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.658259||||0.1391|TWO_SIDED|95.0|0.38|1.15|||Regression, Cox||The Cox regression model was used to estimate the relative risk of the time to death for all causes in Late Epoetin beta therapy group compared to the Early Epoetin beta therapy treatment group.|||1.15|0.38|0.1391
72413531|NCT00321919|144336138|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.804594||||0.4985|TWO_SIDED|95.0|0.43|1.51|||Regression, Cox||The Cox regression model was used to estimate the relative risk of time to first cardiovascular intervention in Late Epoetin beta therapy group compared to the Early Epoetin beta therapy group|||1.51|0.43|0.4985
72413532|NCT00321919|144336140|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.82046||||0.3419|TWO_SIDED|95.0|0.55|1.23|||Regression, Cox||The Cox regression model was used to estimate the relative risk of the time to first hospitalization for cardiovascular reasons in Late Epoetin beta therapy group compared to the Early Epoetin beta therapy group.|||1.23|0.55|0.3419
72413533|NCT00321919|144336147|SUPERIORITY_OR_OTHER|||||||0.0029|TWO_SIDED||||||ANCOVA|||Mean Change from Baseline in the Score of General health scale of Quality of life for Year 1.||||0.0029
72413534|NCT00321919|144336147|SUPERIORITY_OR_OTHER|||||||0.0081|TWO_SIDED||||||ANCOVA|||Mean Change from Baseline in the Score of General health scale of Quality of life for Year 2||||0.0081
72413535|NCT00321919|144336147|SUPERIORITY_OR_OTHER|||||||0.0005|TWO_SIDED||||||ANCOVA|||Mean Change from Baseline in the Score of Mental health scale of Quality of life for Year 1||||0.0005
72584827|NCT00502242|144701133|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Fold Change|2.74|||||TWO_SIDED||||||||Adjusted for baseline|Change from Baseline at Week 8, Placebo||||
72584828|NCT00502242|144701133|SUPERIORITY_OR_OTHER||Treatment Ratio|0.61||||0.0002|TWO_SIDED|95.0|0.47|0.79||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|ANCOVA|ANCOVA model with change in the logarithmic U alb/c as dependent variable, treatment and region/race as factors, and logarithmic baseline as covariate|Treatment ratio (Ramipril/Placebo) in the geometric mean fold-change.|Change from Baseline at Week 8, Ramipril vs. Placebo||0.79|0.47|0.0002
72584829|NCT00502242|144701133|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Fold Change|1.91|||||TWO_SIDED||||||||Adjusted for baseline|Change from Baseline at Week 12, Ramipril||||
72584830|NCT00502242|144701133|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Fold Change|2.92|||||TWO_SIDED||||||||Adjusted for baseline|Change from Baseline at Week 12, Placebo||||
72584831|NCT00502242|144701133|SUPERIORITY_OR_OTHER||Treatment Ratio|0.65||||0.0032|TWO_SIDED|95.0|0.49|0.87||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|ANCOVA|ANCOVA model with change in the logarithmic U alb/c as dependent variable, treatment and region/race as factors, and logarithmic baseline as covariate|Treatment ratio (Ramipril/Placebo) in the geometric mean fold-change.|Change from Baseline at Week 12, Ramipril vs. Placebo||0.87|0.49|0.0032
72584832|NCT00502242|144701133|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Fold Change|2.33|||||TWO_SIDED||||||||Adjusted for baseline|Change from Baseline at Week 24, Ramipril||||
72584833|NCT00502242|144701133|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Fold Change|3.39|||||TWO_SIDED||||||||Adjusted for baseline|Change from Baseline at Week 24, Placebo||||
72584834|NCT00502242|144701133|SUPERIORITY_OR_OTHER||Treatment Ratio|0.69||||0.013|TWO_SIDED|95.0|0.51|0.92||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|ANCOVA|ANCOVA model with change in the logarithmic U alb/c as dependent variable, treatment and region/race as factors, and logarithmic baseline as covariate|Treatment ratio (Ramipril/Placebo) in the geometric mean fold-change.|Change from Baseline at Week 24, Ramipril vs. Placebo||0.92|0.51|0.0130
72584835|NCT00502242|144701133|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Fold Change|2.5|||||TWO_SIDED||||||||Adjusted for baseline|Change from Baseline at Week 30, Ramipril||||
72584836|NCT00502242|144701133|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Fold Change|3.39|||||TWO_SIDED||||||||Adjusted for baseline|Change from Baseline at Week 30, Placebo||||
72584837|NCT00502242|144701133|SUPERIORITY_OR_OTHER||Treatment Ratio|0.74||||0.0577|TWO_SIDED|95.0|0.54|1.01||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|ANCOVA|ANCOVA model with change in the logarithmic U alb/c as dependent variable, treatment and region/race as factors, and logarithmic baseline as covariate|Treatment ratio (Ramipril/Placebo) in the geometric mean fold-change.|Change from Baseline at Week 30, Ramipril vs. Placebo||1.01|0.54|0.0577
72584838|NCT00502242|144701133|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Fold Change|2.52|||||TWO_SIDED||||||||Adjusted for baseline|Change from Baseline at Week 36, Ramipril||||
72584839|NCT00502242|144701133|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Fold Change|3.27|||||TWO_SIDED||||||||Adjusted for baseline|Change from Baseline at Week 36, Placebo||||
72584840|NCT00502242|144701133|SUPERIORITY_OR_OTHER||Treatment Ratio|0.77||||0.1146|TWO_SIDED|95.0|0.56|1.07||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|ANCOVA|ANCOVA model with change in the logarithmic U alb/c as dependent variable, treatment and region/race as factors, and logarithmic baseline as covariate|Treatment ratio (Ramipril/Placebo) in the geometric mean fold-change.|Change from Baseline at Week 36, Ramipril vs. Placebo||1.07|0.56|0.1146
72584841|NCT00502242|144701133|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Fold Change|2.92|||||TWO_SIDED||||||||Adjusted for baseline|Change from Baseline at Week 52, Ramipril||||
72584842|NCT00502242|144701133|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Fold Change|3.45|||||TWO_SIDED||||||||Adjusted for baseline|Change from Baseline at Week 52, Placebo||||
72413536|NCT00321919|144336147|SUPERIORITY_OR_OTHER|||||||0.0965|TWO_SIDED||||||ANCOVA|||Mean Change from Baseline in the Score of Mental Health scale of Quality of life for Year 2||||0.0965
72584843|NCT00502242|144701133|SUPERIORITY_OR_OTHER||Treatment Ratio|0.85||||0.3496|TWO_SIDED|95.0|0.6|1.2||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|ANCOVA|ANCOVA model with change in the logarithmic U alb/c as dependent variable, treatment and region/race as factors, and logarithmic baseline as covariate|Treatment ratio (Ramipril/Placebo) in the geometric mean fold-change.|Change from Baseline at Week 52, Ramipril vs. Placebo||1.20|0.60|0.3496
72584844|NCT00502242|144701134|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|Fisher Exact|||Up to 24 weeks post-conversion||||1.0000
72584845|NCT00502242|144701134|SUPERIORITY_OR_OTHER|||||||0.1115|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|Fisher Exact|||Up to 52 weeks post-conversion||||0.1115
72584846|NCT00502242|144701135|SUPERIORITY_OR_OTHER||Adjusted LS Mean Difference|-0.86|STANDARD_ERROR_OF_MEAN|1.26||0.4933|TWO_SIDED|95.0|-3.33|1.61||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|ANCOVA|ANCOVA model with MDRD change as dependent variable, treatment and region/race as factors, and baseline as covariate.|Adjusted for baseline|Change from Baseline at Week 12||1.61|-3.33|0.4933
72584847|NCT00502242|144701135|SUPERIORITY_OR_OTHER||Adjusted LS Mean Difference|2.48|STANDARD_ERROR_OF_MEAN|1.45||0.0888|TWO_SIDED|95.0|-0.38|5.33||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|ANCOVA|ANCOVA model with MDRD change as dependent variable, treatment and region/race as factors, and baseline as covariate.|Adjusted for baseline|Change from Baseline at Week 24||5.33|-0.38|0.0888
72584848|NCT00502242|144701135|SUPERIORITY_OR_OTHER||Adjusted LS Mean Difference|2.12|STANDARD_ERROR_OF_MEAN|1.46||0.1475|TWO_SIDED|95.0|-0.75|4.99||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|ANCOVA|ANCOVA model with MDRD change as dependent variable, treatment and region/race as factors, and baseline as covariate|Adjusted for baseline|Change from Baseline at Week 52||4.99|-0.75|0.1475
72584849|NCT00502242|144701136|SUPERIORITY_OR_OTHER||Treatment Ratio|0.84||||0.1167|TWO_SIDED|95.0|0.68|1.04||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|ANCOVA|Log (Fraction of albumin to protein in urine) as dependent variable, treatment and region/race as factor, and Log(baseline) as covariate.|Treatment ratio (Ramipril/Placebo) in the geometric mean.|Week 24||1.04|0.68|0.1167
72584850|NCT00502242|144701136|SUPERIORITY_OR_OTHER||Treatment Ratio|1.04||||0.7519|TWO_SIDED|95.0|0.82|1.31||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|ANCOVA|Log (Fraction of albumin to protein in urine) as dependent variable, treatment and region/race as factor, and Log(baseline) as covariate.|Treatment ratio (Ramipril/Placebo) in the geometric mean.|Week 52||1.31|0.82|0.7519
72584851|NCT00502242|144701137|SUPERIORITY_OR_OTHER|||||||0.47|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|Fisher Exact|||Pre-SRL, Low DBP ≤50 mmHg||||0.470
72584852|NCT00502242|144701137|SUPERIORITY_OR_OTHER|||||||0.22|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|Fisher Exact|||Pre-SRL, High DBP ≥110 mmHg||||0.220
72584853|NCT00502242|144701137|SUPERIORITY_OR_OTHER|||||||0.47|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|Fisher Exact|||Pre-SRL, Low SBP: ≤90 mmHg||||0.470
72584854|NCT00502242|144701137|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|Fisher Exact|||Pre-SRL, High SBP: ≥180 mmHg||||1.000
72413537|NCT00321919|144336147|SUPERIORITY_OR_OTHER|||||||0.0004|TWO_SIDED||||||ANCOVA|||Mean Change from Baseline in the Score of Physical function scale of Quality of life for Year 1||||0.0004
72413538|NCT00321919|144336147|SUPERIORITY_OR_OTHER|||||||0.9864|TWO_SIDED||||||ANCOVA|||Mean Change from Baseline in the Score of Physical function scale of Quality of life for Year 2||||0.9864
72413539|NCT00321919|144336147|SUPERIORITY_OR_OTHER|||||||0.0097|TWO_SIDED||||||ANCOVA|||Mean Change from Baseline in the Score of Physical Role scale of Quality of life for Year 1||||0.0097
72584855|NCT00502242|144701137|SUPERIORITY_OR_OTHER|||||||0.725|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|Fisher Exact|||On Therapy, Low DBP ≤50 mmHg||||0.725
72584856|NCT00502242|144701137|SUPERIORITY_OR_OTHER|||||||0.227|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|Fisher Exact|||On Therapy, High DBP ≥110 mmHg||||0.227
72584857|NCT00502242|144701137|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|Fisher Exact|||On Therapy, Low SBP: ≤90 mmHg||||1.000
72584858|NCT00502242|144701137|SUPERIORITY_OR_OTHER|||||||0.106|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|Fisher Exact|||On Therapy, High SBP: ≥180 mmHg||||0.106
72584859|NCT00502242|144701137|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|Fisher Exact|||Off Therapy, High DBP ≥110 mmHg||||1.000
72584860|NCT00502242|144701137|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|Fisher Exact|||Off Therapy, Low SBP: ≤90 mmHg||||1.000
72584861|NCT00502242|144701137|SUPERIORITY_OR_OTHER|||||||0.475|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|Fisher Exact|||Baseline, Low DBP ≤50 mmHg||||0.475
72584862|NCT00502242|144701137|SUPERIORITY_OR_OTHER|||||||0.475|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|Fisher Exact|||Baseline, Low SBP: ≤90 mmHg||||0.475
72584863|NCT00502242|144701139|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|Fisher Exact|||Baseline||||1.000
72584864|NCT00502242|144701139|SUPERIORITY_OR_OTHER|||||||0.626|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|Fisher Exact|||Pre-SRL||||0.626
72413540|NCT00321919|144336147|SUPERIORITY_OR_OTHER|||||||0.167|TWO_SIDED||||||ANCOVA|||Mean Change from Baseline in the Score of Physical Role scale of Quality of life for Year 2||||0.1670
72413541|NCT00321919|144336147|SUPERIORITY_OR_OTHER|||||||0.0058|TWO_SIDED||||||ANCOVA|||Mean Change from Baseline in the Score of Social function scale of Quality of life for Year 1||||0.0058
72413542|NCT00321919|144336147|SUPERIORITY_OR_OTHER|||||||0.1455|TWO_SIDED||||||ANCOVA|||Mean Change from Baseline in the Score of Social function scale of Quality of life for Year 2||||0.1455
72413543|NCT00321919|144336147|SUPERIORITY_OR_OTHER|||||||0.0009|TWO_SIDED||||||ANCOVA|||Mean Change from Baseline in the Score of Vitality function scale of Quality of life for Year 1||||0.0009
72584865|NCT00502242|144701139|SUPERIORITY_OR_OTHER|||||||0.297|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|Fisher Exact|||On-Therapy||||0.297
72584866|NCT00502242|144701139|SUPERIORITY_OR_OTHER|||||||0.356|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|Fisher Exact|||Off-Therapy||||0.356
72584867|NCT00502242|144701140|SUPERIORITY_OR_OTHER|||||||0.064|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|Fisher Exact|||Baseline||||0.064
72584868|NCT00502242|144701140|SUPERIORITY_OR_OTHER|||||||0.069|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|Fisher Exact|||Pre-SRL||||0.069
72584869|NCT00502242|144701140|SUPERIORITY_OR_OTHER|||||||0.752|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|Fisher Exact|||On-Therapy||||0.752
72584870|NCT00502242|144701140|SUPERIORITY_OR_OTHER|||||||0.261|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|Fisher Exact|||Off-Therapy||||0.261
72584871|NCT00502242|144701141|SUPERIORITY_OR_OTHER||Difference in Adjusted Means|-0.09|STANDARD_ERROR_OF_MEAN|0.1||0.381|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|ANCOVA|ANCOVA with treatment as a factor and baseline as a covariate||TC, Week 4||||0.381
72584872|NCT00502242|144701141|SUPERIORITY_OR_OTHER||Difference in Adjusted Means|0.01|STANDARD_ERROR_OF_MEAN|0.13||0.956|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|ANCOVA|ANCOVA with treatment as a factor and baseline as a covariate||TC, Week 12||||0.956
72584873|NCT00502242|144701141|SUPERIORITY_OR_OTHER||Difference in adjusted means|0.02|STANDARD_ERROR_OF_MEAN|0.14||0.903|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|ANCOVA|ANCOVA with treatment as a factor and baseline as a covariate||TC, Week 24||||0.903
72584874|NCT00502242|144701141|SUPERIORITY_OR_OTHER||Difference in Adjusted Means|0.1|STANDARD_ERROR_OF_MEAN|0.15||0.503|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|ANCOVA|ANCOVA with treatment as a factor and baseline as a covariate||TC, Week 52||||0.503
72584875|NCT00502242|144701141|SUPERIORITY_OR_OTHER||Difference in Adjusted Means|-0.03|STANDARD_ERROR_OF_MEAN|0.03||0.451|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|ANCOVA|ANCOVA with treatment as a factor and baseline as a covariate||HDL-C, Week 4||||0.451
72584876|NCT00502242|144701141|SUPERIORITY_OR_OTHER||Difference in Adjusted Means|0.0|STANDARD_ERROR_OF_MEAN|0.03||0.919|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|ANCOVA|ANCOVA with treatment as a factor and baseline as a covariate||HDL-C, Week 12||||0.919
72584877|NCT00502242|144701141|SUPERIORITY_OR_OTHER||Difference in Adjusted Means|0.02|STANDARD_ERROR_OF_MEAN|0.04||0.637|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|ANCOVA|ANCOVA with treatment as a factor and baseline as a covariate||HDL-C, Week 24||||0.637
72584878|NCT00502242|144701141|SUPERIORITY_OR_OTHER||Difference in Adjusted Means|0.05|STANDARD_ERROR_OF_MEAN|0.05||0.229|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|ANCOVA|ANCOVA with treatment as a factor and baseline as a covariate||HDL-C, Week 52||||0.229
72552190|NCT00048581|144635016|SUPERIORITY_OR_OTHER||Est. of Diff: Day 141 ACR 50|20.9|||<|0.001|TWO_SIDED|95.0|12.2|29.5|||Cochran-Mantel-Haenszel|All statistical tests and CI were 2-sided. Percentage of participants with response compared by estimate of weighted difference (Est of Weighted Diff)|Differences in ACR response between the two treatment groups represent the weighted average of the individual stratum differences.|If ACR20 comparison was significant (5% level), then CMH Chi-square test compared ACR 50 response between groups (5% level). If the ACR20 analysis was not significant (5% level), then the comparison for ACR 50 response was not undertaken. A 2-sided Cochran-Mantel-Haenszel (CMH) Chi-square test was used to compare these two treatment groups at the .05 level of significance, with stratification based on baseline history of anti-TNF status (current or prior use).||29.5|12.2|<0.001
72552191|NCT00048581|144635016|SUPERIORITY_OR_OTHER||Est. of Diff: Day 141 ACR 70|10.2|||<|0.001|TWO_SIDED|95.0|4.4|16.0|||Cochran-Mantel-Haenszel|All statistical tests and CI were 2-sided. Percentage of participants with response compared by estimate of weighted difference (Est of Weighted Diff)|Differences in ACR response between the two treatment groups represent the weighted average of the individual stratum differences.|If ACR20 comparison was significant (5% level), then CMH Chi-square test compared ACR 70 response between groups (5% level). If the ACR20 analysis was not significant (5% level), then the comparison for ACR 70 response was not undertaken. A 2-sided Cochran-Mantel-Haenszel (CMH) Chi-square test was used to compare these two treatment groups at the .05 level of significance, with stratification based on baseline history of anti-TNF status (current or prior use).||16.0|4.4|<0.001
72552192|NCT00048581|144635016|SUPERIORITY_OR_OTHER||Est. of Diff: Day 169 ACR 20|30.8|||<|0.001|TWO_SIDED|95.0|20.0|41.7|||Cochran-Mantel-Haenszel|All statistical tests and CI were 2-sided. Percentage of participants with response compared by estimate of difference (Est of Diff)|Differences in ACR response between the two treatment groups represent the weighted average of the individual stratum differences.|Differences in ACR 20 between the treatment arm receiving ABA plus background DMARDs and the treatment arm receiving PLA plus background DMARDs were compared using a 2-sided Cochran-Mantel-Haenszel (CMH) Chi-square test (.05 level of significance), with stratification based on baseline history of anti-TNF status (current or prior use).||41.7|20.0|<0.001
72552193|NCT00048581|144635016|SUPERIORITY_OR_OTHER||Est. of Diff: Day 169 ACR 50|16.6|||<|0.001|TWO_SIDED|95.0|8.6|24.5|||Cochran-Mantel-Haenszel|All statistical tests and CI were 2-sided. Percentage of participants with response compared by estimate of weighted difference (Est of Weighted Diff)|Differences in ACR response between the two treatment groups represent the weighted average of the individual stratum differences.|If ACR20 comparison was significant (5% level), then CMH Chi-square test compared ACR 50 response between groups (5% level). If the ACR20 analysis was not significant (5% level), then the comparison for ACR 50 response was not undertaken. A 2-sided Cochran-Mantel-Haenszel (CMH) Chi-square test was used to compare these two treatment groups at the .05 level of significance, with stratification based on baseline history of anti-TNF status (current or prior use).||24.5|8.6|<0.001
72552194|NCT00048581|144635016|SUPERIORITY_OR_OTHER||Est. of Diff: Day 169 ACR 70|8.7||||0.003|TWO_SIDED|95.0|2.7|14.6|||Cochran-Mantel-Haenszel|All statistical tests and CI were 2-sided. Percentage of participants with response compared by estimate of difference (Est of Weighted Diff)|Differences in ACR response between the two treatment groups represent the weighted average of the individual stratum differences.|If ACR20 comparison was significant (5% level), then CMH Chi-square test compared ACR 70 response between groups (5% level). If the ACR20 analysis was not significant (5% level), then the comparison for ACR 70 response was not undertaken. A 2-sided Cochran-Mantel-Haenszel (CMH) Chi-square test was used to compare these two treatment groups at the .05 level of significance, with stratification based on baseline history of anti-TNF status (current or prior use).||14.6|2.7|0.003
72552195|NCT00048581|144635037|SUPERIORITY_OR_OTHER||Adj Diff: Day 85 PCS|3.63|||<|0.001|TWO_SIDED|95.0|1.89|5.38|||ANCOVA|||Differences in mean changes from baseline between the 2 treatment groups (ABA and PLA) in PCS, MCS, and the 8 subscale scores at Day 85 were compared using ANCOVA models. Adjusted difference (Adj Diff) from PLA group with 95% CIs and p-values were calculated, and adjustment was based on ANCOVA model with treatment group as factor and baseline value as covariate.||5.38|1.89|<0.001
72552196|NCT00048581|144635037|SUPERIORITY_OR_OTHER||Adj Diff: Day 85 MCS|2.57||||0.017|TWO_SIDED|95.0|0.47|4.67|||ANCOVA|||Differences in mean changes from baseline between the 2 treatment groups (ABA and PLA) in PCS, MCS, and the 8 subscale scores at Day 85 were compared using ANCOVA models. Adjusted difference (Adj Diff) from PLA group with 95% CIs and p-values were calculated, and adjustment was based on ANCOVA model with treatment group as factor and baseline value as covariate.||4.67|0.47|0.017
72552197|NCT00048581|144635037|SUPERIORITY_OR_OTHER||Adj Diff: Day 85 Physical Function|1.7||||0.052|TWO_SIDED|95.0|-0.01|3.41|||ANCOVA|||Differences in mean changes from baseline between the 2 treatment groups (ABA and PLA) in PCS, MCS, and the 8 subscale scores at Day 85 were compared using ANCOVA models. Adjusted difference (Adj Diff) from PLA group with 95% CIs and p-values were calculated, and adjustment was based on ANCOVA model with treatment group as factor and baseline value as covariate.||3.41|-0.01|0.052
72552198|NCT00048581|144635037|SUPERIORITY_OR_OTHER||Adj Diff: Day 85 Role-Physical|3.01||||0.007|TWO_SIDED|95.0|0.83|5.19|||ANCOVA|||Differences in mean changes from baseline between the 2 treatment groups (ABA and PLA) in PCS, MCS, and the 8 subscale scores at Day 85 were compared using ANCOVA models. Adjusted difference (Adj Diff) from PLA group with 95% CIs and p-values were calculated, and adjustment was based on ANCOVA model with treatment group as factor and baseline value as covariate.||5.19|0.83|0.007
72552199|NCT00048581|144635037|SUPERIORITY_OR_OTHER||Adj Diff: Day 85 Bodily Pain|5.62|||<|0.001|TWO_SIDED|95.0|3.77|7.47|||ANCOVA|||Differences in mean changes from baseline between the 2 treatment groups (ABA and PLA) in PCS, MCS, and the 8 subscale scores at Day 85 were compared using ANCOVA models. Adjusted difference (Adj Diff) from PLA group with 95% CIs and p-values were calculated, and adjustment was based on ANCOVA model with treatment group as factor and baseline value as covariate.||7.47|3.77|<0.001
72584879|NCT00502242|144701141|SUPERIORITY_OR_OTHER||Difference in Adjusted Means|0.03|STANDARD_ERROR_OF_MEAN|0.09||0.766|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|ANCOVA|ANCOVA with treatment as a factor and baseline as a covariate||LDL-C, Week 4||||0.766
72552200|NCT00048581|144635037|SUPERIORITY_OR_OTHER||Adj Diff: General Health|2.51||||0.001|TWO_SIDED|95.0|0.99|4.02|||ANCOVA|||Differences in mean changes from baseline between the 2 treatment groups (ABA and PLA) in PCS, MCS, and the 8 subscale scores at Day 85 were compared using ANCOVA models. Adjusted difference (Adj Diff) from PLA group with 95% CIs and p-values were calculated, and adjustment was based on ANCOVA model with treatment group as factor and baseline value as covariate.||4.02|0.99|0.001
72552201|NCT00048581|144635037|SUPERIORITY_OR_OTHER||Adj Diff: Day 85 Vitality|3.17||||0.001|TWO_SIDED|95.0|1.24|5.1|||ANCOVA|||Differences in mean changes from baseline between the 2 treatment groups (ABA and PLA) in PCS, MCS, and the 8 subscale scores at Day 85 were compared using ANCOVA models. Adjusted difference (Adj Diff) from PLA group with 95% CIs and p-values were calculated, and adjustment was based on ANCOVA model with treatment group as factor and baseline value as covariate.||5.10|1.24|0.001
72552202|NCT00048581|144635037|SUPERIORITY_OR_OTHER||Adj Diff: Day 85 Social Functioning|4.69|||<|0.001|TWO_SIDED|95.0|2.59|6.79|||ANCOVA|||Differences in mean changes from baseline between the 2 treatment groups (ABA and PLA) in PCS, MCS, and the 8 subscale scores at Day 85 were compared using ANCOVA models. Adjusted difference (Adj Diff) from PLA group with 95% CIs and p-values were calculated, and adjustment was based on ANCOVA model with treatment group as factor and baseline value as covariate.||6.79|2.59|<0.001
72552203|NCT00048581|144635037|SUPERIORITY_OR_OTHER||Adj Diff: Day 85 Role Emotional|0.97||||0.494|TWO_SIDED|95.0|-1.82|3.77|||ANCOVA|||Differences in mean changes from baseline between the 2 treatment groups (ABA and PLA) in PCS, MCS, and the 8 subscale scores at Day 85 were compared using ANCOVA models. Adjusted difference (Adj Diff) from PLA group with 95% CIs and p-values were calculated, and adjustment was based on ANCOVA model with treatment group as factor and baseline value as covariate.||3.77|-1.82|0.494
72552204|NCT00048581|144635037|SUPERIORITY_OR_OTHER||Adj Diff: Day 85 Mental Health|2.59||||0.009|TWO_SIDED|95.0|0.65|4.54|||ANCOVA|||Differences in mean changes from baseline between the 2 treatment groups (ABA and PLA) in PCS, MCS, and the 8 subscale scores at Day 85 were compared using ANCOVA models. Adjusted difference (Adj Diff) from PLA group with 95% CIs and p-values were calculated, and adjustment was based on ANCOVA model with treatment group as factor and baseline value as covariate.||4.54|0.65|0.009
72552205|NCT00048581|144635039|SUPERIORITY_OR_OTHER||Adj Diff: Day 169 PCS|5.46|||<|0.001|TWO_SIDED|95.0|3.64|7.29|||ANCOVA|||Differences in mean changes from baseline between the 2 treatment groups (ABA and PLA) in PCS, MCS, and the 8 subscale scores at Day 85 were compared using ANCOVA models. Adjusted difference (Adj Diff) from PLA group with 95% CIs and p-values were calculated, and adjustment was based on ANCOVA model with treatment group as factor and baseline value as covariate.||7.29|3.64|<0.001
72552206|NCT00048581|144635039|SUPERIORITY_OR_OTHER||Adj Diff: Day 169 MCS|3.04||||0.005|TWO_SIDED|95.0|0.91|5.17|||ANCOVA|||Differences in mean changes from baseline between the 2 treatment groups (ABA and PLA) in PCS, MCS, and the 8 subscale scores at Day 85 were compared using ANCOVA models. Adjusted difference (Adj Diff) from PLA group with 95% CIs and p-values were calculated, and adjustment was based on ANCOVA model with treatment group as factor and baseline value as covariate.||5.17|0.91|0.005
72552207|NCT00048581|144635039|SUPERIORITY_OR_OTHER||Adj Diff: Day 169 Physical Function|4.03|||<|0.001|TWO_SIDED|95.0|2.08|5.98|||ANCOVA|||Differences in mean changes from baseline between the 2 treatment groups (ABA and PLA) in PCS, MCS, and the 8 subscale scores at Day 85 were compared using ANCOVA models. Adjusted difference (Adj Diff) from PLA group with 95% CIs and p-values were calculated, and adjustment was based on ANCOVA model with treatment group as factor and baseline value as covariate.||5.98|2.08|<0.001
72552208|NCT00048581|144635039|SUPERIORITY_OR_OTHER||Adj Diff: Day 169 Role-Physical|5.22|||<|0.001|TWO_SIDED|95.0|3.1|7.35|||ANCOVA|||||7.35|3.10|<0.001
72552209|NCT00048581|144635039|SUPERIORITY_OR_OTHER||Adj Diff: Day 169 Bodily Pain|6.24|||<|0.001|TWO_SIDED|95.0|4.37|8.11|||ANCOVA|||||8.11|4.37|<0.001
72552210|NCT00048581|144635039|SUPERIORITY_OR_OTHER||Adj Diff: Day 169 General Health|3.27|||<|0.001|TWO_SIDED|95.0|1.64|4.9|||ANCOVA|||Differences in mean changes from baseline between the 2 treatment groups (ABA and PLA) in PCS, MCS, and the 8 subscale scores at Day 85 were compared using ANCOVA models. Adjusted difference (Adj Diff) from PLA group with 95% CIs and p-values were calculated, and adjustment was based on ANCOVA model with treatment group as factor and baseline value as covariate.||4.90|1.64|<0.001
72552211|NCT00048581|144635039|SUPERIORITY_OR_OTHER||Adj Diff: Day 169 Vitality|4.78|||<|0.001|TWO_SIDED|95.0|2.76|6.79|||ANCOVA|||Differences in mean changes from baseline between the 2 treatment groups (ABA and PLA) in PCS, MCS, and the 8 subscale scores at Day 85 were compared using ANCOVA models. Adjusted difference (Adj Diff) from PLA group with 95% CIs and p-values were calculated, and adjustment was based on ANCOVA model with treatment group as factor and baseline value as covariate.||6.79|2.76|<0.001
72413544|NCT00321919|144336147|SUPERIORITY_OR_OTHER|||||||0.0123|TWO_SIDED||||||ANCOVA|||Mean Change from Baseline in the Score of Vitality function scale of Quality of life for Year 2||||0.0123
72552212|NCT00048581|144635039|SUPERIORITY_OR_OTHER||Adj Diff: Day 169 Social Functioning|4.92|||<|0.001|TWO_SIDED|95.0|2.71|7.12|||ANCOVA|||Differences in mean changes from baseline between the 2 treatment groups (ABA and PLA) in PCS, MCS, and the 8 subscale scores at Day 85 were compared using ANCOVA models. Adjusted difference (Adj Diff) from PLA group with 95% CIs and p-values were calculated, and adjustment was based on ANCOVA model with treatment group as factor and baseline value as covariate.||7.12|2.71|<0.001
72552213|NCT00048581|144635039|SUPERIORITY_OR_OTHER||Adj Diff: Day 169 Role Emotional|3.54||||0.013|TWO_SIDED|95.0|0.74|6.33|||ANCOVA|||Differences in mean changes from baseline between the 2 treatment groups (ABA and PLA) in PCS, MCS, and the 8 subscale scores at Day 85 were compared using ANCOVA models. Adjusted difference (Adj Diff) from PLA group with 95% CIs and p-values were calculated, and adjustment was based on ANCOVA model with treatment group as factor and baseline value as covariate.||6.33|0.74|0.013
72552214|NCT00048581|144635039|SUPERIORITY_OR_OTHER||Adj Diff: Mental Health|2.7||||0.006|TWO_SIDED|95.0|0.79|4.6|||ANCOVA|||Differences in mean changes from baseline between the 2 treatment groups (ABA and PLA) in PCS, MCS, and the 8 subscale scores at Day 85 were compared using ANCOVA models. Adjusted difference (Adj Diff) from PLA group with 95% CIs and p-values were calculated, and adjustment was based on ANCOVA model with treatment group as factor and baseline value as covariate.||4.60|0.79|0.006
72413545|NCT00321919|144336147|SUPERIORITY_OR_OTHER|||||||0.3155|TWO_SIDED||||||ANCOVA|||Mean Change from Baseline in the Score of Bodily pain scale of Quality of life for Year 1||||0.3155
72413546|NCT00321919|144336147|SUPERIORITY_OR_OTHER|||||||0.7076|TWO_SIDED||||||ANCOVA|||Mean Change from Baseline in the Score of Bodily pain scale of Quality of life for Year 2||||0.7076
72413547|NCT00321919|144336147|SUPERIORITY_OR_OTHER|||||||0.1291|TWO_SIDED||||||ANCOVA|||Mean Change from Baseline in the Score of Emotional role scale of Quality of life for Year 1||||0.1291
72584880|NCT00502242|144701141|SUPERIORITY_OR_OTHER||Difference in Adjusted Means|0.14|STANDARD_ERROR_OF_MEAN|0.11||0.217|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|ANCOVA|ANCOVA with treatment as a factor and baseline as a covariate||LDL-C, Week 12||||0.217
72584881|NCT00502242|144701141|SUPERIORITY_OR_OTHER||Difference in Adjusted Means|0.1|STANDARD_ERROR_OF_MEAN|0.13||0.457|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|ANCOVA|ANCOVA with treatment as a factor and baseline as a covariate||LDL-C, Week 24||||0.457
72584882|NCT00502242|144701141|SUPERIORITY_OR_OTHER||Difference in Adjusted Means|0.26|STANDARD_ERROR_OF_MEAN|0.13||0.041|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|ANCOVA|ANCOVA with treatment as a factor and baseline as a covariate||LDL-C, Week 52||||0.041
72584883|NCT00502242|144701141|SUPERIORITY_OR_OTHER||Difference in Adjusted Means|-0.25|STANDARD_ERROR_OF_MEAN|0.12||0.044|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|ANCOVA|ANCOVA with treatment as a factor and baseline as a covariate||Triglycerides, Week 4||||0.044
72584884|NCT00502242|144701141|SUPERIORITY_OR_OTHER||Difference in Adjusted Means|-0.2|STANDARD_ERROR_OF_MEAN|0.15||0.18|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|ANCOVA|ANCOVA with treatment as a factor and baseline as a covariate||Triglycerides, Week 12||||0.180
72584885|NCT00502242|144701141|SUPERIORITY_OR_OTHER||Difference in Adjusted Means|-0.19|STANDARD_ERROR_OF_MEAN|0.17||0.264|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|ANCOVA|ANCOVA with treatment as a factor and baseline as a covariate||Triglycerides, Week 24||||0.264
72584886|NCT00502242|144701141|SUPERIORITY_OR_OTHER||Difference in Adjusted Means|-0.14|STANDARD_ERROR_OF_MEAN|0.17||0.408|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|ANCOVA|ANCOVA with treatment as a factor and baseline as a covariate||Triglycerides, Week 52||||0.408
72584887|NCT00502242|144701142|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.487||||0.0732|TWO_SIDED|95.0|0.887|6.978||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|Log Rank||Hazard ratio was based on the Cox proportional hazards model.|||6.978|0.887|0.0732
72584888|NCT00502242|144701144|SUPERIORITY_OR_OTHER|||||||0.7165|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel row mean test||Post-SRL, AM BCAR||||0.7165
72584889|NCT00502242|144701144|SUPERIORITY_OR_OTHER|||||||0.4795|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel row mean test||Post-SRL (On-Therapy), AM BCAR||||0.4795
72584890|NCT00502242|144701145|SUPERIORITY_OR_OTHER|||||||0.4773|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|Fisher Exact|||Week 52||||0.4773
72584891|NCT00502242|144701146|SUPERIORITY_OR_OTHER|||||||0.124|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|Fisher Exact|||Baseline||||0.124
72584892|NCT00502242|144701146|SUPERIORITY_OR_OTHER|||||||0.41|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|Fisher Exact|||Pre-SRL||||0.410
72584893|NCT00502242|144701146|SUPERIORITY_OR_OTHER|||||||0.423|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|Fisher Exact|||On-Therapy||||0.423
72584894|NCT00502242|144701146|SUPERIORITY_OR_OTHER|||||||0.297|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|Fisher Exact|||Off-Therapy||||0.297
72584895|NCT00502242|144701147|SUPERIORITY_OR_OTHER|||||||0.726|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|Fisher Exact|||||||0.726
72584896|NCT00502242|144701148|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|Fisher Exact|||||||1.000
72584897|NCT00502242|144701149|SUPERIORITY_OR_OTHER|||||||0.753|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|Fisher Exact|||||||0.753
72584898|NCT00502242|144701150|SUPERIORITY_OR_OTHER|||||||0.224|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|Fisher Exact|||Baseline||||0.224
72584899|NCT00502242|144701150|SUPERIORITY_OR_OTHER|||||||0.179|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|Fisher Exact|||Pre-SRL||||0.179
72584900|NCT00502242|144701150|SUPERIORITY_OR_OTHER|||||||0.604|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|Fisher Exact|||On-Therapy||||0.604
72584901|NCT00502242|144701150|SUPERIORITY_OR_OTHER|||||||0.486|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|Fisher Exact|||Off-Therapy||||0.486
72584902|NCT00442897|144701191|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|3.714||||||95.0|1.77|7.78|||||Odds ratio was adjusted by baseline LDL strata.|||7.78|1.77|
72584903|NCT00442897|144701192|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.579||||||95.0|1.32|5.06|||||Odds ratio was adjusted by baseline LDL strata.|||5.06|1.32|
72584904|NCT02104219|144701193|SUPERIORITY_OR_OTHER|||||||0.0755|TWO_SIDED|||||The p-value is based on a nonparametric sign test used to determine whether the median RGI-C score differs from 0 for each time interval. No multiple comparisons or multiplicity adjustments were conducted.|Sign test|||Pairs of radiographs were centrally evaluated by 3 independent, blinded pediatric radiologists trained in the assessment of the skeletal manifestations of HPP. The mean RGI-C score across the 3 radiologists was calculated and served as the patient's RGI-C score for a specific time point||||0.0755
72584905|NCT02104219|144701194|SUPERIORITY_OR_OTHER|||||||0.6344|TWO_SIDED|||||The p-value is based on a nonparametric sign test used to determine whether the median change in height Z-score from baseline to last assessment differs from 0. No multiple comparisons or multiplicity adjustments were conducted.|Sign test|||The earliest documented height measurement that was abstracted within the period from 5 to 15 years of age, inclusive, was defined as the baseline height. Height measurements were assigned to Z-scores calculated using Centers for Disease Control and Prevention 2000 growth charts and methodology. Changes in height Z-score from Baseline were computed by subtracting baseline height Z-score from post baseline height Z-scores. The post baseline time points were grouped by time intervals.||||0.6344
72584906|NCT02104219|144701195|SUPERIORITY_OR_OTHER|||||||0.452|TWO_SIDED|||||The p-value is based on a nonparametric sign test used to determine whether the median change in weight Z-score from baseline to last assessment differs from 0. No multiple comparisons or multiplicity adjustments were conducted.|Sign test|||The earliest documented weight measurement that was abstracted within the period from 5 to 15 years of age, inclusive, was defined as the baseline weight. Weight measurements were assigned to Z-scores calculated using Centers for Disease Control and Prevention 2000 growth charts and methodology. Changes in weight Z-score from Baseline were computed by subtracting baseline weight Z-score from post baseline weight Z-scores. The post baseline time points were grouped by time intervals.||||0.4520
72584907|NCT02104219|144701196|SUPERIORITY_OR_OTHER|||||||0.4545|TWO_SIDED|||||The p-value is based on a nonparametric sign test used to determine whether change from baseline in the median RSS score differs from 0 for each time interval. No multiple comparisons or multiplicity adjustments were conducted.|Sign test|||The Baseline x-ray set defined for RGI-C, which was compared with its subsequent x-ray sets, was also used as the Baseline x-ray set for the RSS reading. Changes from Baseline were computed based on this baseline RSS score, and postbaseline time points were grouped by intervals of time from Baseline.||||0.4545
72584908|NCT03137160|144701241|SUPERIORITY|||||||1|||||||Fisher Exact|||This is the Investigator Global Assessment comparing the proportion of subjects who achieved a 2 pt reduction at study close (0).||||1
72584909|NCT01339260|144701242|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.48||||0.001|TWO_SIDED|95.0|1.16|1.87||If superiority of netupitant/palonosetron was established for the CR delayed, CR acute and then CR overall at cycle 1 were to be tested according to a hierarchical procedure;no adjustment for multiplicity was needed.The a priori threshold was 0.050|Cochran-Mantel-Haenszel||Cochran Mantel Haenszel (CMH) test including treatment, age class and region as strata. All missing data were to be imputed as treatment failures.|The null hypothesis was rejected if the 2 sided p value from the Cochran Mantel Haenszel test was less than or equal to 0.050 and in the right direction i.e., the Odds Ratio (OR) was in favor of netupitant/palonosetron. Power was 90%.||1.87|1.16|0.001
72584910|NCT01339260|144701243|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.37||||0.047|TWO_SIDED|95.0|1.0|1.87||If the null hypothesis for CR delayed was rejected, analysis of the first key secondary endpoint CR acute was to be performed. Since the analysis was performed according to a hierarchical procedure, no further adjustment for multiplicity was needed.|Cochran-Mantel-Haenszel|Cochran Mantel Haenszel (CMH) test including treatment, age class and region as strata. All missing data were to be imputed as treatment failures.||CR in the acute phase was to be tested using the same 2 sided CMH test as for the primary endpoint. netupitant/palonosetron combination was to be considered superior to palonosetron in the acute phase if the 2 sided p value from the CMH was less than or equal to 0.050 and in the right direction.||1.87|1.0|0.047
72584911|NCT01339260|144701244|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.47||||0.001|TWO_SIDED|95.0|1.17|1.85||If the null hypothesis for CR acute was rejected, analysis of the 2nd key secondary endpoint CR overall was to be performed. Since the analysis was performed according to a hierarchical procedure, no further adjustment for multiplicity was needed.|Cochran-Mantel-Haenszel|Cochran Mantel Haenszel (CMH) test including treatment, age class and region as strata. All missing data were to be imputed as treatment failures.||CR in the overall phase was to be tested using the same 2 sided CMH test as for the primary endpoint. netupitant/palonosetron combination was to be considered superior to palonosetron in the overall phase if the 2 sided p value from the CMH was less than or equal to 0.050 and in the right direction.||1.85|1.17|0.001
72584912|NCT03448419|144701253|SUPERIORITY||Median difference (HL-estimate)|-4.0||||0.4236|TWO_SIDED|95.0|-16.0|6.0|||Wilcoxon rank test, normal approximation||Empagliflozin vs. Placebo. For estimation of effect, the non-parametric Hodge-Lehman (HL) estimate for the median difference was calculated.|H0: There is no difference between the effect of placebo and the effect of empagliflozin.||6.0|-16.0|0.4236
72413548|NCT00321919|144336147|SUPERIORITY_OR_OTHER|||||||0.5528|TWO_SIDED||||||ANCOVA|||Mean Change from Baseline in the Score of Emotional role scale of Quality of life for Year 2||||0.5528
72413549|NCT00760929|144336158|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.4301||90.0|0.58|1.21|||Wald Test|||||1.21|0.58|0.4301
72552215|NCT00048581|144635041|SUPERIORITY_OR_OTHER||Adj M Chg from BL: HAQ-DI|-0.34|||<|0.001|TWO_SIDED|95.0|-0.44|-0.23|||ANCOVA|||Mean changes from baseline in HAQ disability index were compared between treatment groups using analysis of covariance (ANCOVA) models and 95% confidence intervals were calculated. This analysis was based on the LOCF data set. Similar analyses were also conducted for each of the 8 individual categories: 1) dressing and grooming; 2) arising; 3) eating; 4) walking; 5) hygiene; 6) reach; 7) grip; and 8) common daily activities. Adjusted Mean Change From Baseline = Adj M Chg From BL||-0.23|-0.44|<0.001
72552216|NCT00048581|144635041|SUPERIORITY_OR_OTHER||Adj M Chg from BL: Dressing and Grooming|-0.32|||<|0.001|TWO_SIDED|95.0|-0.49|-0.14|||ANCOVA|||Mean changes from baseline in HAQ disability index were compared between treatment groups using analysis of covariance (ANCOVA) models and 95% confidence intervals were calculated. This analysis was based on the LOCF data set. Similar analyses were also conducted for each of the 8 individual categories: 1) dressing and grooming; 2) arising; 3) eating; 4) walking; 5) hygiene; 6) reach; 7) grip; and 8) common daily activities. Adjusted Mean Change From Baseline= Adj M Chg From BL||-0.14|-0.49|<0.001
72552217|NCT00048581|144635041|SUPERIORITY_OR_OTHER||Adj M Chg from BL: Arising|-0.32|||<|0.001|TWO_SIDED|95.0|-0.47|-0.16|||ANCOVA|||Mean changes from baseline in HAQ disability index were compared between treatment groups using analysis of covariance (ANCOVA) models and 95% confidence intervals were calculated. This analysis was based on the LOCF data set. Similar analyses were also conducted for each of the 8 individual categories: 1) dressing and grooming; 2) arising; 3) eating; 4) walking; 5) hygiene; 6) reach; 7) grip; and 8) common daily activities. Adjusted Mean Change From Baseline= Adj M Chg From BL||-0.16|-0.47|<0.001
72552218|NCT00048581|144635041|SUPERIORITY_OR_OTHER||Adj M Chg from BL: Eating|-0.48|||<|0.001|TWO_SIDED|95.0|-0.65|-0.3|||ANCOVA|||Mean changes from baseline in HAQ disability index were compared between treatment groups using analysis of covariance (ANCOVA) models and 95% confidence intervals were calculated. This analysis was based on the LOCF data set. Similar analyses were also conducted for each of the 8 individual categories: 1) dressing and grooming; 2) arising; 3) eating; 4) walking; 5) hygiene; 6) reach; 7) grip; and 8) common daily activities. Adjusted Mean Change From Baseline = Adj M Chg From BL||-0.30|-0.65|<0.001
72552219|NCT00048581|144635041|SUPERIORITY_OR_OTHER||Adj M Chg from BL: Walking|-0.26||||0.003|TWO_SIDED|95.0|-0.44|-0.09|||ANCOVA|||Mean changes from baseline in HAQ disability index were compared between treatment groups using analysis of covariance (ANCOVA) models and 95% confidence intervals were calculated. This analysis was based on the LOCF data set. Similar analyses were also conducted for each of the 8 individual categories: 1) dressing and grooming; 2) arising; 3) eating; 4) walking; 5) hygiene; 6) reach; 7) grip; and 8) common daily activities. Adjusted Mean Change From Baseline= Adj M Chg from BL||-0.09|-0.44|0.003
72552220|NCT00048581|144635041|SUPERIORITY_OR_OTHER||Adj M Chg from BL: Hygiene|-0.22||||0.01|TWO_SIDED|95.0|-0.39|-0.05|||ANCOVA|||Mean changes from baseline in HAQ disability index were compared between treatment groups using analysis of covariance (ANCOVA) models and 95% confidence intervals were calculated. This analysis was based on the LOCF data set. Similar analyses were also conducted for each of the 8 individual categories: 1) dressing and grooming; 2) arising; 3) eating; 4) walking; 5) hygiene; 6) reach; 7) grip; and 8) common daily activities. Adjusted Mean Change From Baseline= Adj M Chg from BL||-0.05|-0.39|0.010
72552221|NCT00048581|144635041|SUPERIORITY_OR_OTHER||Adj M Chg from BL: Reaching|-0.43|||<|0.001|TWO_SIDED|95.0|-0.61|-0.25|||ANCOVA|||Mean changes from baseline in HAQ disability index were compared between treatment groups using analysis of covariance (ANCOVA) models and 95% confidence intervals were calculated. This analysis was based on the LOCF data set. Similar analyses were also conducted for each of the 8 individual categories: 1) dressing and grooming; 2) arising; 3) eating; 4) walking; 5) hygiene; 6) reach; 7) grip; and 8) common daily activities. Adjusted Mean Change From Baseline= Adj M Chg from BL||-0.25|-0.61|<0.001
72552222|NCT00048581|144635041|SUPERIORITY_OR_OTHER||Adj M Chg from BL: Gripping|-0.32|||<|0.001|TWO_SIDED|95.0|-0.49|-0.15|||ANCOVA|||Mean changes from baseline in HAQ disability index were compared between treatment groups using analysis of covariance (ANCOVA) models and 95% confidence intervals were calculated. This analysis was based on the LOCF data set. Similar analyses were also conducted for each of the 8 individual categories: 1) dressing and grooming; 2) arising; 3) eating; 4) walking; 5) hygiene; 6) reach; 7) grip; and 8) common daily activities. Adjusted Mean Change From Baseline= Adj M Chg from BL||-0.15|-0.49|<0.001
72584913|NCT03448419|144701254|SUPERIORITY||Median difference (HL-estimate)|3.13||||0.0893|TWO_SIDED|95.0|0.0|7.29|||Wilcoxon rank test, normal approximation||Empagliflozin vs. Placebo. For estimation of effect, the non-parametric Hodge-Lehman (HL) estimate for the median difference was calculated.|H0: There is no difference between the effect of placebo and the effect of empagliflozin.||7.29|0.00|0.0893
72584914|NCT03448419|144701255|SUPERIORITY||Median Difference (HL-estimate)|0.1||||0.4702|TWO_SIDED|95.0|-0.2|0.4|||Wilcoxon rank test, normal approximation||Empagliflozin vs. Placebo. For estimation of effect, the non-parametric Hodge-Lehman (HL) estimate for the median difference was calculated.|H0: There is no difference between the effect of placebo and the effect of empagliflozin.||0.40|-0.20|0.4702
72584915|NCT03448419|144701256|SUPERIORITY||Median difference (HL-estimate)|0.0||||0.983|TWO_SIDED|95.0|-9.0|9.0|||Wilcoxon rank test, normal approximation||Empagliflozin vs. Placebo. For estimation of effect, the non-parametric Hodge-Lehman (HL) estimate for the median difference was calculated.|H0: There is no difference between the effect of placebo and the effect of empagliflozin.||9.0|-9.0|0.9830
72584916|NCT03448419|144701257|OTHER||Difference of adjusted means|-0.31||||0.0053|TWO_SIDED|95.0|-0.53|-0.09|||Mixed Model repeated Measures (MMRM)|Covariates: visit-by-treatment interaction, baseline-by-visit interaction. Unstructured covariance structure was used to model within-patient errors.||||-0.09|-0.53|0.0053
72584917|NCT03448419|144701258|OTHER|||||||0.6189|||||||Cochran-Mantel-Haenszel test|Test on difference in mean treatment scores, based on modified ridit scores.||||||0.6189
72584918|NCT03448419|144701259|OTHER|||||||0.6672|||||||Cochran-Mantel-Haenszel test|Test on difference in mean treatment scores, based on modified ridit scores.||||||0.6672
72584919|NCT03448419|144701260|OTHER|||||||0.5147|||||||Cochran-Mantel-Haenszel test|Test on difference in mean treatment scores, based on modified ridit scores.||||||0.5147
72584920|NCT03448419|144701261|OTHER|||||||0.863|||||||Cochran-Mantel-Haenszel test|Test on difference in mean treatment scores, based on modified ridit scores.||||||0.8630
72584921|NCT03448419|144701262|OTHER||Adjusted geometric mean ratio|0.91||||0.141|TWO_SIDED|95.0|0.81|1.03|||Mixed Model repeated Measures (MMRM)|Covariates: NT-proBNP-by-visit interaction and visit-by-treatment interaction. Unstructured covariance structure to model within-patient errors.|Adjusted geometric mean ratio \[Empagliflozin/Placebo\] of relative change to baseline.|The endpoint 'relative change from baseline in NT-proBNP at Week 12' (after log-transformation) was evaluated using an MMRM analysis over time with baseline log-transformed NT-proBNP-by-visit interaction and visit-by-treatment interaction as covariates.Unstructured covariance structure was used to model within-patient errors.||1.03|0.81|0.1410
72584922|NCT04548193|144701294|SUPERIORITY||Mean Difference (Final Values)|6.14||||0.28|TWO_SIDED|95.0|-5.72|17.99|||Wilcoxon (Mann-Whitney)|||||17.99|-5.72|0.28
72584923|NCT04548193|144701295|SUPERIORITY||Mean Difference (Final Values)|0.72||||0.0054|TWO_SIDED|95.0|0.06|1.38|||Wilcoxon (Mann-Whitney)|||||1.38|0.06|.0054
72584924|NCT04548193|144701297|SUPERIORITY||Mean Difference (Final Values)|0.94||||0.0098|TWO_SIDED|95.0|0.24|1.65|||Wilcoxon (Mann-Whitney)|||||1.65|0.24|.0098
72584925|NCT00630825|144701298|SUPERIORITY_OR_OTHER||||||<|0.001||||||P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.|ANCOVA|||||||<0.001
72584926|NCT00630825|144701298|SUPERIORITY_OR_OTHER||||||<|0.001||||||P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.|ANCOVA|||||||<0.001
72584927|NCT00630825|144701298|SUPERIORITY_OR_OTHER||||||<|0.001||||||P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.|ANCOVA|||||||<0.001
72584928|NCT00630825|144701299|SUPERIORITY_OR_OTHER||||||<|0.001||||||P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.|ANCOVA|||||||<0.001
72584929|NCT00630825|144701299|SUPERIORITY_OR_OTHER||||||<|0.001||||||P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.|ANCOVA|||||||<0.001
72584930|NCT00630825|144701299|SUPERIORITY_OR_OTHER||||||<|0.001||||||P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.|ANCOVA|||||||<0.001
72584931|NCT00630825|144701300|SUPERIORITY_OR_OTHER||||||<|0.001||||||Treatment comparison at Week 16. P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.|ANCOVA|||||||<0.001
72584932|NCT00630825|144701300|SUPERIORITY_OR_OTHER|||||||0.047||||||Treatment comparison at Week 16. P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.|ANCOVA|||||||0.047
72584933|NCT00630825|144701300|SUPERIORITY_OR_OTHER|||||||0.025||||||Treatment comparison at Week 16. P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.|ANCOVA|||||||0.025
72584934|NCT00630825|144701301|SUPERIORITY_OR_OTHER||||||<|0.001||||||Treatment comparison at Week 4. P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.|ANCOVA|||||||<0.001
72584935|NCT00630825|144701301|SUPERIORITY_OR_OTHER||||||<|0.001||||||Treatment comparison at Week 4. P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.|ANCOVA|||||||<0.001
72584936|NCT00630825|144701301|SUPERIORITY_OR_OTHER||||||<|0.001||||||Treatment comparison at Week 4. P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.|ANCOVA|||||||<0.001
72552223|NCT00048581|144635041|SUPERIORITY_OR_OTHER||Adj M Chg from BL: Activities|-0.4|||<|0.001|TWO_SIDED|95.0|-0.58|-0.22|||ANCOVA|||Mean changes from baseline in HAQ disability index were compared between treatment groups using analysis of covariance (ANCOVA) models and 95% confidence intervals were calculated. This analysis was based on the LOCF data set. Similar analyses were also conducted for each of the 8 individual categories: 1) dressing and grooming; 2) arising; 3) eating; 4) walking; 5) hygiene; 6) reach; 7) grip; and 8) common daily activities. Adjusted Mean Change From Baseline= Adj M Chg from BL||-0.22|-0.58|<0.001
72552224|NCT01059903|144635098|NON_INFERIORITY_OR_EQUIVALENCE|If the 90% CI for the ratio of geometric LS-Means is included within 0.8-1.25, the patches are considered bioequivalent.|Ratio of geometric LS-Means|0.9028|||||TWO_SIDED|90.0|0.8411|0.969|||ANOVA|ANOVA for log-transformed values has been used as the basis for calculation of point estimates (LS-Means) and Confidence Intervals (CIs).|Bioequivalence is concluded if the 90% CIs for the ratio Treatment A/ Treatment B are fully included in the acceptance range from 0.8- 1.25 for AUC(0-tz), AUC(0-inf) and Cmax.|Bioequivalence testing by using the 90% Confidence Interval (CI).||0.9690|0.8411|
72552225|NCT01059903|144635099|NON_INFERIORITY_OR_EQUIVALENCE|If the 90% CI for the ratio of geometric LS-Means is included within 0.8-1.25, the patches are considered bioequivalent.|Ratio of geometric LS-Means|0.9506|||||TWO_SIDED|90.0|0.8833|1.0231|||ANOVA|ANOVA for log-transformed values has been used as the basis for calculation of point estimates (LS-Means) and Confidence Intervals (CIs).|Bioequivalence is concluded if the 90% CIs for the ratio Treatment A/ Treatment B are fully included in the acceptance range from 0.8- 1.25 for AUC(0-tz), AUC(0-inf) and Cmax.|Bioequivalence testing by using the 90% Confidence Interval (CI).||1.0231|0.8833|
72584937|NCT00630825|144701301|SUPERIORITY_OR_OTHER||||||<|0.001||||||Treatment comparison at Week 8. P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.|ANCOVA|||||||<0.001
72584938|NCT00630825|144701301|SUPERIORITY_OR_OTHER||||||<|0.001||||||Treatment comparison at Week 8. P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.|ANCOVA|||||||<0.001
72584939|NCT00630825|144701301|SUPERIORITY_OR_OTHER||||||<|0.001||||||Treatment comparison at Week 8. P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.|ANCOVA|||||||<0.001
72584940|NCT00630825|144701301|SUPERIORITY_OR_OTHER||||||<|0.001||||||Treatment comparison at Week 16. P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.|ANCOVA|||||||<0.001
72584941|NCT00630825|144701301|SUPERIORITY_OR_OTHER||||||<|0.001||||||Treatment comparison at Week 16. P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.|ANCOVA|||||||<0.001
72584942|NCT00630825|144701301|SUPERIORITY_OR_OTHER||||||<|0.001||||||Treatment comparison at Week 16. P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.|ANCOVA|||||||<0.001
72584943|NCT00630825|144701302|SUPERIORITY_OR_OTHER||||||<|0.001||||||Treatment comparison of HOMA2-%B. P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.|ANCOVA|||||||<0.001
72584944|NCT00630825|144701302|SUPERIORITY_OR_OTHER||||||<|0.001||||||Treatment comparison of HOMA2-%B. P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.|ANCOVA|||||||<0.001
72584945|NCT00630825|144701302|SUPERIORITY_OR_OTHER|||||||0.004||||||Treatment comparison of HOMA2-%B. P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.|ANCOVA|||||||0.004
72584946|NCT00630825|144701302|SUPERIORITY_OR_OTHER|||||||0.904||||||Treatment comparison of HOMA2-%S. P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.|ANCOVA|||||||0.904
72584947|NCT00630825|144701302|SUPERIORITY_OR_OTHER|||||||0.138|||||||ANCOVA|Treatment comparison of HOMA2-%S. P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.||||||0.138
72584948|NCT00630825|144701302|SUPERIORITY_OR_OTHER|||||||0.729||||||Treatment comparison of HOMA2-%S. P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.|ANCOVA|||||||0.729
72584949|NCT00630825|144701304|SUPERIORITY_OR_OTHER||||||<|0.001||||||Treatment comparison at 4 weeks. P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.|ANCOVA|||||||<0.001
72584950|NCT00630825|144701304|SUPERIORITY_OR_OTHER||||||<|0.001||||||Treatment comparison at 4 weeks. P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.|ANCOVA|||||||<0.001
72584951|NCT00630825|144701304|SUPERIORITY_OR_OTHER|||||||0.113||||||Treatment comparison at 4 weeks. P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.|ANCOVA|||||||0.113
72584952|NCT00630825|144701304|SUPERIORITY_OR_OTHER||||||<|0.001||||||Treatment comparison at 8 weeks. P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.|ANCOVA|||||||<0.001
72584953|NCT00630825|144701304|SUPERIORITY_OR_OTHER||||||<|0.001||||||Treatment comparison at 8 weeks. P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.|ANCOVA|||||||<0.001
72584954|NCT00630825|144701304|SUPERIORITY_OR_OTHER||||||<|0.001||||||Treatment comparison at 8 weeks. P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.|ANCOVA|||||||<0.001
72584955|NCT00630825|144701304|SUPERIORITY_OR_OTHER||||||<|0.001||||||Treatment comparison at 16 weeks. P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.|ANCOVA|||||||<0.001
72584956|NCT00630825|144701304|SUPERIORITY_OR_OTHER|||||||0.004||||||Treatment comparison at 16 weeks. P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.|ANCOVA|||||||0.004
72584957|NCT00630825|144701304|SUPERIORITY_OR_OTHER|||||||0.001||||||Treatment comparison at 16 weeks. P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.|ANCOVA|||||||0.001
72584958|NCT00630825|144701305|SUPERIORITY_OR_OTHER|||||||0.009||||||P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.|ANCOVA|||||||0.009
72584959|NCT00630825|144701305|SUPERIORITY_OR_OTHER|||||||0.028||||||P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.|ANCOVA|||||||0.028
72584960|NCT00630825|144701305|SUPERIORITY_OR_OTHER|||||||0.047||||||P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.|ANCOVA|||||||0.047
72584961|NCT02275819|144701314|SUPERIORITY|||||||0.14|||||||t-test, 2 sided|||||||.14
72584962|NCT02275819|144701315|SUPERIORITY|||||||0.22|||||||t-test, 2 sided|||||||.22
72584963|NCT02275819|144701316|SUPERIORITY|||||||0.12|||||||t-test, 2 sided|||||||.12
72584964|NCT02275819|144701317|SUPERIORITY|||||||0.08|||||||t-test, 2 sided|||||||.08
72584965|NCT02275819|144701318|SUPERIORITY|||||||0.43|||||||t-test, 2 sided|||||||0.43
72584966|NCT02211209|144701327|SUPERIORITY||Least Squares Mean Difference|-94.1|||<|0.0001|TWO_SIDED|95.0|-121.7|-66.6|||ANCOVA|||||-66.6|-121.7|< 0.0001
72584967|NCT02211209|144701329|SUPERIORITY||Least Squares Mean Difference|-1804.0|STANDARD_ERROR_OF_MEAN|251.0|<|0.0001|TWO_SIDED|95.0|-2306.0|-1302.0|||ANCOVA|||||-1302|-2306|< 0.0001
72584968|NCT02211209|144701330|SUPERIORITY||Odds Ratio (OR)|186.16||||0.0001|TWO_SIDED|95.0|12.86||NA indicates that the upper limit of 95% CI was not estimable. The upper limit of the odds ratio estimate from the logistic regression model was \>999.999, and it was reported as NA per statistical reporting convention.||Regression, Logistic||||||12.86|0.0001
72584969|NCT02211209|144701331|SUPERIORITY||Odds Ratio (OR)|99.69|||<|0.0001|TWO_SIDED|95.0|15.75|631.06|||Regression, Logistic|||||631.06|15.75|<0.0001
72584970|NCT02211209|144701333|SUPERIORITY|||||||0.6131|||||||t-test, 2 sided|||||||0.6131
72584971|NCT02211209|144701334|SUPERIORITY||Least Squares Mean Difference|138.0||||0.1206|TWO_SIDED|95.0|-36.0|312.0|||ANCOVA|||||312|-36|0.1206
72584972|NCT02792062|144701337|SUPERIORITY_OR_OTHER||Least Square Mean Ratio (%)|113.06||||0.659|TWO_SIDED|90.0|70.37|181.67|||Mixed Models Analysis|||Mixed effect model with natural log-transformed Cmax of unchanged TAK-385 as dependent variables, arm, treatment period and dosing condition as fixed effects, and participants as a random effect was used to calculate the difference between the dosing conditions (value before breakfast - value in fasted condition without breakfast).||181.67|70.37|0.659
72584973|NCT02792062|144701337|SUPERIORITY_OR_OTHER||Least Square Mean Ratio (%)|45.43||||0.012|TWO_SIDED|90.0|27.86|74.07|||Mixed Models Analysis|||Mixed effect model with natural log-transformed Cmax of unchanged TAK-385 as dependent variables, arm, treatment period and dosing condition as fixed effects, and participants as a random effect was used to calculate the difference between the dosing conditions (value after breakfast - value in fasted condition without breakfast).||74.07|27.86|0.012
72584974|NCT02792062|144701338|SUPERIORITY_OR_OTHER||Least Square Mean Ratio (%)|84.28||||0.238|TWO_SIDED|90.0|66.09|107.47|||Mixed Models Analysis|||Mixed effect model with natural log-transformed AUC∞ of unchanged TAK-385 as dependent variables, arm, treatment period and dosing condition as fixed effects, and participants as a random effect was used to calculate the difference between the dosing conditions (value before breakfast - value in fasted condition without breakfast).||107.47|66.09|0.238
72584975|NCT02792062|144701338|SUPERIORITY_OR_OTHER||Least Square Mean Ratio (%)|53.2|||<|0.001|TWO_SIDED|90.0|41.39|68.37|||Mixed Models Analysis|||Mixed effect model with natural log-transformed AUC∞ of unchanged TAK-385 as dependent variables, arm, treatment period and dosing condition as fixed effects, and participants as a random effect was used to calculate the difference between the dosing conditions (value after breakfast - value in fasted condition without breakfast).||68.37|41.39|<0.001
72584976|NCT02792062|144701339|SUPERIORITY_OR_OTHER||Least Square Mean Ratio (%)|84.68||||0.256|TWO_SIDED|90.0|66.23|108.27|||Mixed Models Analysis|||Mixed effect model with natural log-transformed AUC(0-120) of unchanged TAK-385 as dependent variables, arm, treatment period and dosing condition as fixed effects, and participants as a random effect was used to calculate the difference between the dosing conditions (value before breakfast - value in fasted condition without breakfast).||108.27|66.23|0.256
72584977|NCT02792062|144701339|SUPERIORITY_OR_OTHER||Least Square Mean Ratio (%)|52.56|||<|0.001|TWO_SIDED|90.0|40.78|67.74|||Mixed Models Analysis|||Mixed effect model with natural log-transformed AUC(0-120) of unchanged TAK-385 as dependent variables, arm, treatment period and dosing condition as fixed effects, and participants as a random effect was used to calculate the difference between the dosing conditions (value after breakfast - value in fasted condition without breakfast).||67.74|40.78|<0.001
72413550|NCT00760929|144336158|SUPERIORITY||Hazard Ratio (HR)|0.61||||0.0342||90.0|0.42|0.9|||Wald Test|||||0.90|0.42|0.0342
72413551|NCT02099838|144336162|SUPERIORITY_OR_OTHER||||||<|0.0001||||||The a priori threshold for statistical significance is 0.05; the change was statistical significant with P-value less than 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in change of HbA1c between before and after treatment in Pioglitazone and Metformin group. The test was performed with a significance level of 0.05.||||<0.0001
72413552|NCT02099838|144336162|SUPERIORITY_OR_OTHER|||||||0.065||||||The a priori threshold for statistical significance is 0.05; the change was statistical significant with P-value less than 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in change of HbA1c between before and after treatment in Placebo group. The test was performed with a significance level of 0.05.||||0.0650
72413553|NCT02099838|144336162|SUPERIORITY_OR_OTHER|||||||0.0005||||||The a priori threshold for statistical significance is 0.05; the change was statistical significant with P-value less than 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in change of HbA1c between Pioglitazone and Metformin group and Placebo group. The test was performed with a significance level of 0.05.||||0.0005
72413554|NCT02099838|144336163|SUPERIORITY_OR_OTHER||||||<|0.0001||||||The a priori threshold for statistical significance is 0.05; the change was statistical significant with P-value less than 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in change of FPG between before and after treatment in Pioglitazone and Metformin group. The test was performed with a significance level of 0.05.||||<0.0001
72413555|NCT02099838|144336163|SUPERIORITY_OR_OTHER|||||||0.0849||||||The a priori threshold for statistical significance is 0.05; the change was statistical significant with P-value less than 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in change of FPG between before and after treatment in Placebo group. The test was performed with a significance level of 0.05.||||0.0849
72413556|NCT02099838|144336163|SUPERIORITY_OR_OTHER|||||||0.0005||||||The a priori threshold for statistical significance is 0.05; the change was statistical significant with P-value less than 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in change of FPG between Pioglitazone and Metformin group and Placebo group. The test was performed with a significance level of 0.05.||||0.0005
72413557|NCT02099838|144336164|SUPERIORITY_OR_OTHER||||||<|0.0001||||||The a priori threshold for statistical significance is 0.05; the change was statistical significant with P-value less than 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in change of 2hPPG between before and after treatment in Pioglitazone and Metformin group. The test was performed with a significance level of 0.05.||||<0.0001
72584978|NCT02792062|144701340|SUPERIORITY_OR_OTHER||Least Square Mean Ratio (%)|84.68||||0.256|TWO_SIDED|90.0|66.23|108.27|||Mixed Models Analysis|||Mixed effect model with natural log-transformed AUClast of unchanged TAK-385 as dependent variables, arm, treatment period and dosing condition as fixed effects, and participants as a random effect was used to calculate the difference between the dosing conditions (value before breakfast - value in fasted condition without breakfast).||108.27|66.23|0.256
72413558|NCT02099838|144336164|SUPERIORITY_OR_OTHER|||||||0.2428||||||The a priori threshold for statistical significance is 0.05; the change was statistical significant with P-value less than 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in change of 2hPPG between before and after treatment in Placebo group. The test was performed with a significance level of 0.05.||||0.2428
72413559|NCT02099838|144336164|SUPERIORITY_OR_OTHER|||||||0.0003||||||The a priori threshold for statistical significance is 0.05; the change was statistical significant with P-value less than 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in change of 2hPPG between Pioglitazone and Metformin group and Placebo group. The test was performed with a significance level of 0.05.||||0.0003
72413560|NCT02099838|144336165|SUPERIORITY_OR_OTHER||||||<|0.0001||||||The a priori threshold for statistical significance is 0.05; the change was statistical significant with P-value less than 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in change of fasting insulin between before and after treatment in Pioglitazone and Metformin group. The test was performed with a significance level of 0.05.||||<0.0001
72584979|NCT02792062|144701340|SUPERIORITY_OR_OTHER||Least Square Mean Ratio (%)|52.56|||<|0.001|TWO_SIDED|90.0|40.78|67.74|||Mixed Models Analysis|||Mixed effect model with natural log-transformed AUClast of unchanged TAK-385 as dependent variables, arm, treatment period and dosing condition as fixed effects, and participants as a random effect was used to calculate the difference between the dosing conditions (value after breakfast - value in fasted condition without breakfast).||67.74|40.78|<0.001
72413561|NCT02099838|144336165|SUPERIORITY_OR_OTHER|||||||0.7353||||||The a priori threshold for statistical significance is 0.05; the change was statistical significant with P-value less than 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in change of fasting insulin between before and after treatment in Placebo group.. The test was performed with a significance level of 0.05.||||0.7353
72413562|NCT02099838|144336165|SUPERIORITY_OR_OTHER|||||||0.0013||||||The a priori threshold for statistical significance is 0.05; the change was statistical significant with P-value less than 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in change of fasting insulin between Pioglitazone and Metformin group and Placebo group. The test was performed with a significance level of 0.05.||||0.0013
72584980|NCT03309943|144701347|SUPERIORITY|Mixed model analysis examining the effects of drug condition on response to smoking vs. non-smoking cues (collapsed across category - proximal, standard environment, personal environment). Data were analyzed using the underlying raw values versus collapsing them together.||||||0.019|||||||Mixed Models Analysis|Adjusted for FTCD. Carried out using SPSS Mixed Models with a repeated statement and compound symmetry covariance structure.||||||.019
72584981|NCT03309943|144701348|SUPERIORITY|Mixed model analysis examining the effects of drug condition on response to smoking vs. non-smoking cues (collapsed across category - proximal, standard environment, personal environment). Data were analyzed using the underlying raw values versus collapsing them together.||||||0.83|||||||Mixed Models Analysis|Adjusted for FTCD||||||.830
72413563|NCT02099838|144336166|SUPERIORITY_OR_OTHER|||||||0.1147||||||The a priori threshold for statistical significance is 0.05; the change was statistical significant with P-value less than 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in change of 2-hour postprandial insulin between before and after treatment in Pioglitazone and Metformin group. The test was performed with a significance level of 0.05.||||0.1147
72413564|NCT02099838|144336166|SUPERIORITY_OR_OTHER|||||||0.4006||||||The a priori threshold for statistical significance is 0.05; the change was statistical significant with P-value less than 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in change of 2-hour postprandial insulin between before and after treatment in Placebo group. The test was performed with a significance level of 0.05.||||0.4006
72413565|NCT02099838|144336166|SUPERIORITY_OR_OTHER|||||||0.0614||||||The a priori threshold for statistical significance is 0.05; the change was statistical significant with P-value less than 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in change of 2-hour postprandial insulin between Pioglitazone and Metformin group and Placebo group. The test was performed with a significance level of 0.05.||||0.0614
72413566|NCT02099838|144336167|SUPERIORITY_OR_OTHER|||||||0.3795||||||The a priori threshold for statistical significance is 0.05; the change was statistical significant with P-value less than 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in change of TC between before and after treatment in Pioglitazone and Metformin group. The test was performed with a significance level of 0.05.||||0.3795
72413567|NCT02099838|144336167|SUPERIORITY_OR_OTHER|||||||0.4236||||||The a priori threshold for statistical significance is 0.05; the change was statistical significant with P-value less than 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in change of TC between before and after treatment in Placebo group. The test was performed with a significance level of 0.05.||||0.4236
72413568|NCT02099838|144336167|SUPERIORITY_OR_OTHER|||||||1||||||The a priori threshold for statistical significance is 0.05; the change was statistical significant with P-value less than 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in change of TC between Pioglitazone and Metformin group and Placebo group. The test was performed with a significance level of 0.05.||||1.0000
72413569|NCT02099838|144336168|SUPERIORITY_OR_OTHER|||||||0.3151||||||The a priori threshold for statistical significance is 0.05; the change was statistical significant with P-value less than 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in change of TG between before and after treatment in Pioglitazone and Metformin group. The test was performed with a significance level of 0.05.||||0.3151
72413570|NCT02099838|144336168|SUPERIORITY_OR_OTHER|||||||0.6963||||||The a priori threshold for statistical significance is 0.05; the change was statistical significant with P-value less than 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in change of TG between before and after treatment in Placebo group. The test was performed with a significance level of 0.05.||||0.6963
72413571|NCT02099838|144336168|SUPERIORITY_OR_OTHER|||||||0.3204||||||The a priori threshold for statistical significance is 0.05; the change was statistical significant with P-value less than 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in change of TG between Pioglitazone and Metformin group and Placebo group. The test was performed with a significance level of 0.05.||||0.3204
72584982|NCT03309943|144701349|SUPERIORITY|Mixed model analysis examining the effects of drug condition on response to smoking vs. non-smoking cues (collapsed across category - proximal, standard environment, personal environment). Data were analyzed using the underlying raw values versus collapsing them together.||||||0.006|||||||Mixed Models Analysis|||||||.006
72584983|NCT03309943|144701350|SUPERIORITY|Mixed model analysis examining the effects of drug condition on response to smoking vs. non-smoking cues (collapsed across category - proximal, standard environment, personal environment). Data were analyzed using the underlying raw values versus collapsing them together.||||||0.653|||||||Mixed Models Analysis|||||||.653
72584984|NCT03309943|144701351|SUPERIORITY|Mixed model analysis examining the effects of drug condition on response to smoking vs. non-smoking cues (collapsed across category - proximal, standard environment, personal environment). Data were analyzed using the underlying raw values versus collapsing them together.||||||0.012|||||||Mixed Models Analysis|Adjusted for FTCD||||||.012
72584985|NCT03309943|144701352|SUPERIORITY|Mixed model analysis examining the effects of drug condition on PPI indexes while viewing proximal smoking cues (which drove activation effects).||||||0.013|||||||Mixed Models Analysis|||||||.013
72584986|NCT03309943|144701353|SUPERIORITY|Repeated Measures ANCOVA analysis examining condition differences (adjusting for FTCD score)||||||0.024|||||||Repeated Measures ANCOVA|Adjusted for FTCD.||||||.024
72584987|NCT03309943|144701354|SUPERIORITY|Repeated Measures ANCOVA analysis examining condition differences (adjusting for FTCD score)||||||0.086|||||||Repeated Measures ANCOVA|Adjusted for FTCD score||||||.086
72584988|NCT03309943|144701355|SUPERIORITY|Repeated Measures ANCOVA analysis examining condition differences (adjusting for FTCD score)||||||0.14|||||||Repeated Measures ANCOVA|Adjusted for FTCD score||||||.140
72584989|NCT03309943|144701356|SUPERIORITY|Standard ANCOVA analysis examining condition differences (adjusting for baseline craving and FTCD score).||||||0.556|||||||ANCOVA|Adjusted for baseline craving and FTCD score||||||.556
72584990|NCT03309943|144701357|SUPERIORITY|Standard ANCOVA analysis examining condition differences (adjusting for FTCD score).||||||0.463||||||Adjusted for FTCD score only.|ANCOVA|||||||.463
72584991|NCT00427648|144701406|SUPERIORITY|||||||0.588|||||||Kruskal-Wallis|||null hypothesis - no difference in average number of voids between the 2 groups, power calculation estimated 40 participants needed per arm to show a 2 void difference between lidocaine and saline placebo.||||0.588
72584992|NCT00427648|144701407|SUPERIORITY|||||||0.617|||||||Kruskal-Wallis|||||||0.617
72584993|NCT00427648|144701408|SUPERIORITY|||||||0.441|||||||Kruskal-Wallis|||||||0.441
72584994|NCT00427648|144701409|SUPERIORITY|||||||0.189|||||||Kruskal-Wallis|||||||0.189
72584995|NCT00427648|144701410|SUPERIORITY|||||||0.342|||||||Kruskal-Wallis|||||||0.342
72584996|NCT00427648|144701411|SUPERIORITY|||||||0.802|||||||Kruskal-Wallis|||||||0.802
72584997|NCT00427648|144701412|SUPERIORITY|||||||0.366|||||||Kruskal-Wallis|||||||0.366
72584998|NCT00386360|144701413|SUPERIORITY_OR_OTHER||LS Mean Difference|0.231||||0.7096|TWO_SIDED|95.0|-0.995|1.458|||ANOVA|LS Means are least squares (adjusted) means from ANOVA model with fixed effects for treatment and pooled center.||In Laib 1998, the mean and SD of the annual loss in distal radius BV/TV were reported to be 3.5% and 6.4%, respectively. Assuming the treatment difference and SD of the percent change in distal radius BV/TV for this study were the same, it required enrolling 52 patients for placebo and 104 for risedronate to ensure 80% power to achieve 0.05 level of significance. Sample size estimation based on 2-sided 2-sample t-test and assumed effective size of 0.54 and dropout rate of 20%.||1.458|-0.995|0.7096
72584999|NCT00386360|144701414|SUPERIORITY_OR_OTHER||LS Mean Difference|0.543||||0.2973|TWO_SIDED|95.0|-0.485|1.571|||ANOVA|LS Means are least squares (adjusted) means from ANOVA model with fixed effects for treatment and pooled center.||In Laib 1998, the mean and SD of the annual loss in distal radius BV/TV were reported to be 3.5% and 6.4%, respectively. Assuming the treatment difference and SD of the percent change in distal radius BV/TV for this study were the same, it required enrolling 52 patients for placebo and 104 for risedronate to ensure 80% power to achieve 0.05 level of significance. Sample size estimation based on 2-sided 2-sample t-test and assumed effective size of 0.54 and dropout rate of 20%.||1.571|-0.485|0.2973
72585000|NCT00386360|144701415|SUPERIORITY_OR_OTHER||LS Mean Difference|0.485||||0.1275|TWO_SIDED|95.0|-0.141|1.11|||ANOVA|LS Means are least squares (adjusted) means from ANOVA model with fixed effects for treatment and pooled center.||In Laib 1998, the mean and SD of the annual loss in distal radius BV/TV were reported to be 3.5% and 6.4%, respectively. Assuming the treatment difference and SD of the percent change in distal radius BV/TV for this study were the same, it required enrolling 52 patients for placebo and 104 for risedronate to ensure 80% power to achieve 0.05 level of significance. Sample size estimation based on 2-sided 2-sample t-test and assumed effective size of 0.54 and dropout rate of 20%.||1.110|-0.141|0.1275
72585001|NCT00386360|144701416|SUPERIORITY_OR_OTHER||LS Mean Difference|0.664||||0.336|TWO_SIDED|95.0|-0.697|2.025|||ANOVA|LS Means are least squares (adjusted) means from ANOVA model with fixed effects for treatment and pooled center.||In Laib 1998, the mean and SD of the annual loss in distal radius BV/TV were reported to be 3.5% and 6.4%, respectively. Assuming the treatment difference and SD of the percent change in distal radius BV/TV for this study were the same, it required enrolling 52 patients for placebo and 104 for risedronate to ensure 80% power to achieve 0.05 level of significance. Sample size estimation based on 2-sided 2-sample t-test and assumed effective size of 0.54 and dropout rate of 20%.||2.025|-0.697|0.3360
72585002|NCT00386360|144701417|SUPERIORITY_OR_OTHER||LS Mean Difference|0.334||||0.4565|TWO_SIDED|95.0|-0.551|1.219|||ANOVA|LS Means are least squares (adjusted) means from ANOVA model with fixed effects for treatment and pooled center.||In Laib 1998, the mean and SD of the annual loss in distal radius BV/TV were reported to be 3.5% and 6.4%, respectively. Assuming the treatment difference and SD of the percent change in distal radius BV/TV for this study were the same, it required enrolling 52 patients for placebo and 104 for risedronate to ensure 80% power to achieve 0.05 level of significance. Sample size estimation based on 2-sided 2-sample t-test and assumed effective size of 0.54 and dropout rate of 20%.||1.219|-0.551|0.4565
72585003|NCT00386360|144701418|SUPERIORITY_OR_OTHER||LS Mean Difference|0.611||||0.0614|TWO_SIDED|95.0|-0.03|1.252|||ANOVA|LS Means are least squares (adjusted) means from ANOVA model with fixed effects for treatment and pooled center.||In Laib 1998, the mean and SD of the annual loss in distal radius BV/TV were reported to be 3.5% and 6.4%, respectively. Assuming the treatment difference and SD of the percent change in distal radius BV/TV for this study were the same, it required enrolling 52 patients for placebo and 104 for risedronate to ensure 80% power to achieve 0.05 level of significance. Sample size estimation based on 2-sided 2-sample t-test and assumed effective size of 0.54 and dropout rate of 20%.||1.252|-0.030|0.0614
72585004|NCT00386360|144701419|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.06||||0.9212|TWO_SIDED|95.0|-1.258|1.138|||ANOVA|LS means are least squares (adjusted) means from ANOVA model with fixed effects for treatment and pooled center.||In Laib 1998, the mean and SD of the annual loss in distal radius BV/TV were reported to be 3.5% and 6.4%, respectively. Assuming the treatment difference and SD of the percent change in distal radius BV/TV for this study were the same, it required enrolling 52 patients for placebo and 104 for risedronate to ensure 80% power to achieve 0.05 level of significance. Sample size estimation based on 2-sided 2-sample t-test and assumed effective size of 0.54 and dropout rate of 20%.||1.138|-1.258|0.9212
72413572|NCT02099838|144336169|SUPERIORITY_OR_OTHER|||||||0.0038||||||The a priori threshold for statistical significance is 0.05; the change was statistical significant with P-value less than 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in change of HDL between before and after treatment in Pioglitazone and Metformin group. The test was performed with a significance level of 0.05.||||0.0038
72413573|NCT02099838|144336169|SUPERIORITY_OR_OTHER|||||||0.3812||||||The a priori threshold for statistical significance is 0.05; the change was statistical significant with P-value less than 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in change of HDL between before and after treatment in Placebo group. The test was performed with a significance level of 0.05.||||0.3812
72413574|NCT02099838|144336169|SUPERIORITY_OR_OTHER|||||||0.0108||||||The a priori threshold for statistical significance is 0.05; the change was statistical significant with P-value less than 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in change of HDL between Pioglitazone and Metformin group and Placebo group. The test was performed with a significance level of 0.05.||||0.0108
72413575|NCT02099838|144336170|SUPERIORITY_OR_OTHER|||||||0.5476||||||The a priori threshold for statistical significance is 0.05; the change was statistical significant with P-value less than 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in change of LDL between before and after treatment in Pioglitazone and Metformin group. The test was performed with a significance level of 0.05.||||0.5476
72552226|NCT01059903|144635100|NON_INFERIORITY_OR_EQUIVALENCE|If the 90% CI for the ratio of geometric LS-Means is included within 0.8-1.25, the patches are considered bioequivalent.|Ratio of geometric LS-Means|0.9046|||||TWO_SIDED|90.0|0.8437|0.9699|||ANOVA|ANOVA for log-transformed values has been used as the basis for calculation of point estimates (LS-Means) and Confidence Intervals (CIs).|Bioequivalence is concluded if the 90% CIs for the ratio Treatment A/ Treatment B are fully included in the acceptance range from 0.8- 1.25 for AUC(0-tz), AUC(0-inf) and Cmax.|Bioequivalence testing by using the 90% Confidence Interval (CI).||0.9699|0.8437|
72552227|NCT01375660|144635206|SUPERIORITY_OR_OTHER|||||||0.026|TWO_SIDED||||||ANOVA|||||||0.026
72552228|NCT01375660|144635207|SUPERIORITY_OR_OTHER|||||||0.6|TWO_SIDED||||||ANOVA|||||||0.6
72552229|NCT01375660|144635208|SUPERIORITY_OR_OTHER|||||||0.389|TWO_SIDED||||||ANOVA|||||||0.389
72552230|NCT01375660|144635209|SUPERIORITY_OR_OTHER|||||||0.34|TWO_SIDED|||||P Value for Insulinogenic Index-30 = 0.34|ANOVA|||||||0.34
72552231|NCT01375660|144635210|SUPERIORITY_OR_OTHER|||||||0.22|TWO_SIDED||||||ANOVA|||||||0.22
72552232|NCT01375660|144635211|SUPERIORITY_OR_OTHER|||||||0.13|TWO_SIDED||||||Chi-squared|||||||0.13
72552233|NCT01375660|144635212|SUPERIORITY_OR_OTHER|||||||0.869|TWO_SIDED||||||Chi-squared|||||||0.869
72552234|NCT02058498|144635214|SUPERIORITY_OR_OTHER|||||||0.27|||||||Wilcoxon (Mann-Whitney)|||||||0.27
72552235|NCT03585790|144635217|NON_INFERIORITY|Margin acceptable mean difference (Single Vision - Multifocal) = -5 rating units (0-100 scale, 0 = optimal)||||||0.18|||||||t-test, 1 sided|||Ho: Single Vision - Multifocal \>= M vs. Ho: Single Vision - Multifocal \< M. Alpha = 0.05, two sided beta = 0.80||||0.18
72585005|NCT00386360|144701420|SUPERIORITY_OR_OTHER||LS Mean Difference|3.27|||<|0.0001|TWO_SIDED|95.0|2.231|4.31|||ANOVA|LS Means are least squares (adjusted) means from ANOVA model with fixed effects for treatment and pooled center.||In Laib 1998, the mean and SD of the annual loss in distal radius BV/TV were reported to be 3.5% and 6.4%, respectively. Assuming the treatment difference and SD of the percent change in distal radius BV/TV for this study were the same, it required enrolling 52 patients for placebo and 104 for risedronate to ensure 80% power to achieve 0.05 level of significance. Sample size estimation based on 2-sided 2-sample t-test and assumed effective size of 0.54 and dropout rate of 20%.||4.310|2.231|<0.0001
72585006|NCT00386360|144701421|SUPERIORITY_OR_OTHER||LS Mean Difference|1.444|||<|0.0001|TWO_SIDED|95.0|0.748|2.14|||ANOVA|LS Means are least squares (adjusted) means from ANOVA model with fixed effects for treatment and pooled center.||In Laib 1998, the mean and SD of the annual loss in distal radius BV/TV were reported to be 3.5% and 6.4%, respectively. Assuming the treatment difference and SD of the percent change in distal radius BV/TV for this study were the same, it required enrolling 52 patients for placebo and 104 for risedronate to ensure 80% power to achieve 0.05 level of significance. Sample size estimation based on 2-sided 2-sample t-test and assumed effective size of 0.54 and dropout rate of 20%.||2.140|0.748|<0.0001
72585007|NCT00386360|144701422|SUPERIORITY_OR_OTHER||LS Mean Difference|1.408||||0.0036|TWO_SIDED|95.0|0.469|2.348|||ANOVA|LS Means are least squares (adjusted) means from ANOVA model with fixed effects for treatment and pooled center.||In Laib 1998, the mean and SD of the annual loss in distal radius BV/TV were reported to be 3.5% and 6.4%, respectively. Assuming the treatment difference and SD of the percent change in distal radius BV/TV for this study were the same, it required enrolling 52 patients for placebo and 104 for risedronate to ensure 80% power to achieve 0.05 level of significance. Sample size estimation based on 2-sided 2-sample t-test and assumed effective size of 0.54 and dropout rate of 20%.||2.348|0.469|0.0036
72585008|NCT00386360|144701423|SUPERIORITY_OR_OTHER||LS Mean Difference|1.458||||0.0087|TWO_SIDED|95.0|0.375|2.541|||ANOVA|LS Means are least squares (adjusted) means from ANOVA model with fixed effects for treatment and pooled center.||In Laib 1998, the mean and SD of the annual loss in distal radius BV/TV were reported to be 3.5% and 6.4%, respectively. Assuming the treatment difference and SD of the percent change in distal radius BV/TV for this study were the same, it required enrolling 52 patients for placebo and 104 for risedronate to ensure 80% power to achieve 0.05 level of significance. Sample size estimation based on 2-sided 2-sample t-test and assumed effective size of 0.54 and dropout rate of 20%.||2.541|0.375|0.0087
72585009|NCT00386360|144701424|SUPERIORITY_OR_OTHER||LS Mean Difference|-39.54||||0.0002|TWO_SIDED|95.0|-59.957|-19.123|||ANOVA|LS Means are least squares (adjusted) means from ANOVA model with fixed effects for treatment and pooled center.||In Laib 1998, the mean and SD of the annual loss in distal radius BV/TV were reported to be 3.5% and 6.4%, respectively. Assuming the treatment difference and SD of the percent change in distal radius BV/TV for this study were the same, it required enrolling 52 patients for placebo and 104 for risedronate to ensure 80% power to achieve 0.05 level of significance. Sample size estimation based on 2-sided 2-sample t-test and assumed effective size of 0.54 and dropout rate of 20%.||-19.123|-59.957|0.0002
72585010|NCT00386360|144701425|SUPERIORITY_OR_OTHER||LS Mean Difference|-40.269|||<|0.0001|TWO_SIDED|95.0|-51.3|-29.238|||ANOVA|LS Means are least squares (adjusted) means from ANOVA model with fixed effects for treatment and pooled center.||In Laib 1998, the mean and SD of the annual loss in distal radius BV/TV were reported to be 3.5% and 6.4%, respectively. Assuming the treatment difference and SD of the percent change in distal radius BV/TV for this study were the same, it required enrolling 52 patients for placebo and 104 for risedronate to ensure 80% power to achieve 0.05 level of significance. Sample size estimation based on 2-sided 2-sample t-test and assumed effective size of 0.54 and dropout rate of 20%.||-29.238|-51.300|<0.0001
72585011|NCT00386360|144701426|SUPERIORITY_OR_OTHER||LS Mean Difference|0.092||||0.1385|TWO_SIDED|95.0|-0.03|0.213|||ANOVA|LS Means are least squares (adjusted) means from ANOVA model with fixed effects for treatment and pooled center.||In Laib 1998, the mean and SD of the annual loss in distal radius BV/TV were reported to be 3.5% and 6.4%, respectively. Assuming the treatment difference and SD of the percent change in distal radius BV/TV for this study were the same, it required enrolling 52 patients for placebo and 104 for risedronate to ensure 80% power to achieve 0.05 level of significance. Sample size estimation based on 2-sided 2-sample t-test and assumed effective size of 0.54 and dropout rate of 20%.||0.213|-0.030|0.1385
72585012|NCT01575834|144701430|SUPERIORITY||Odds Ratio (OR)|0.27|||<|0.001|TWO_SIDED|95.0|0.15|0.47||A fixed-sequence testing procedure was used for multiplicity adjustment of the coprimary and a subset of secondary efficacy endpoints to maintain the overall significance level at 0.05.|Regression, Logistic|Based on logistic regression model adjusted for age and prevalent vertebral fracture stratification variables; p-value based on score test.|Values \< 1 for odds ratio favor romosozumab.|||0.47|0.15|< 0.001
72585013|NCT01575834|144701431|SUPERIORITY||Odds Ratio (OR)|0.24|||<|0.001|TWO_SIDED|95.0|0.15|0.39||A fixed-sequence testing procedure was used for multiplicity adjustment of the coprimary and a subset of secondary efficacy endpoints to maintain the overall significance level at 0.05.|Regression, Logistic|Based on logistic regression model adjusted for age and prevalent vertebral fracture stratification variables; p-value based on score test.|Values \< 1 for odds ratio favor romosozumab.|||0.39|0.15|< 0.001
72585014|NCT01575834|144701432|SUPERIORITY||Hazard Ratio (HR)|0.64||||0.008|TWO_SIDED|95.0|0.46|0.89||A fixed-sequence testing procedure was used for multiplicity adjustment of the coprimary and a subset of secondary efficacy endpoints to maintain the overall significance level at 0.05.|Cox proportional hazards|Cox proportional hazards model adjusting for age and prevalent vertebral fracture stratification variables.|Hazard ratio \< 1 favors romosozumab.|||0.89|0.46|0.008
72585015|NCT01575834|144701433|SUPERIORITY||Hazard Ratio (HR)|0.75||||0.096|TWO_SIDED|95.0|0.53|1.05||A fixed-sequence testing procedure was used for multiplicity adjustment of the coprimary and a subset of secondary efficacy endpoints to maintain the overall significance level at 0.05.|Cox proportional hazards|Cox proportional hazards model adjusting for age and prevalent vertebral fracture stratification variables.|Hazard ratio \< 1 favors romosozumab.|||1.05|0.53|0.096
72585016|NCT01575834|144701434|SUPERIORITY||Hazard Ratio (HR)|0.75||||0.057|TWO_SIDED|95.0|0.57|0.97||A fixed-sequence testing procedure was used for multiplicity adjustment of the coprimary and a subset of secondary efficacy endpoints to maintain the overall significance level at 0.05.|Cox proportional hazards|Cox proportional hazards model adjusting for age and prevalent vertebral fracture stratification variables.|Hazard ratio \< 1 favors romosozumab.|||0.97|0.57|0.057
72585017|NCT01575834|144701435|SUPERIORITY||Hazard Ratio (HR)|0.67||||0.096|TWO_SIDED|95.0|0.52|0.87||A fixed-sequence testing procedure was used for multiplicity adjustment of the coprimary and a subset of secondary efficacy endpoints to maintain the overall significance level at 0.05.|Cox proportional hazards|Cox proportional hazards model adjusting for age and prevalent vertebral fracture stratification variables.|Hazard ratio \< 1 favors romosozumab.|||0.87|0.52|0.096
72585018|NCT01575834|144701436|SUPERIORITY||Hazard Ratio (HR)|0.67||||0.096|TWO_SIDED|95.0|0.44|1.02||A fixed-sequence testing procedure was used for multiplicity adjustment of the coprimary and a subset of secondary efficacy endpoints to maintain the overall significance level at 0.05.|Cox proportional hazards|Cox proportional hazards model adjusting for age and prevalent vertebral fracture stratification variables.|Hazard ratio \< 1 favors romosozumab.|||1.02|0.44|0.096
72585019|NCT01575834|144701437|SUPERIORITY||Hazard Ratio (HR)|0.67||||0.096|TWO_SIDED|95.0|0.49|0.91||A fixed-sequence testing procedure was used for multiplicity adjustment of the coprimary and a subset of secondary efficacy endpoints to maintain the overall significance level at 0.05.|Cox proportional hazards|Cox proportional hazards model adjusting for age and prevalent vertebral fracture stratification variables.|Hazard ratio \< 1 favors romosozumab|||0.91|0.49|0.096
72585020|NCT01575834|144701438|SUPERIORITY||Odds Ratio (OR)|0.28||||0.096|TWO_SIDED|95.0|0.17|0.49||A fixed-sequence testing procedure was used for multiplicity adjustment of the coprimary and a subset of secondary efficacy endpoints to maintain the overall significance level at 0.05.|Regression, Logistic|Based on logistic regression model adjusted for age and prevalent vertebral fracture stratification variables; p-value based on score test.|Values \< 1 for odds ratio favor romosozumab.|||0.49|0.17|0.096
72585021|NCT01575834|144701439|SUPERIORITY||Odds Ratio (OR)|0.26||||0.096|TWO_SIDED|95.0|0.16|0.41||A fixed-sequence testing procedure was used for multiplicity adjustment of the coprimary and a subset of secondary efficacy endpoints to maintain the overall significance level at 0.05.|Regression, Logistic|Based on logistic regression model adjusted for age and prevalent vertebral fracture stratification variables; p-value based on score test|Values \< 1 for odds ratio favor romosozumab.|||0.41|0.16|0.096
72585022|NCT01575834|144701440|SUPERIORITY||Hazard Ratio (HR)|0.54||||0.18|TWO_SIDED|95.0|0.22|1.35||A fixed-sequence testing procedure was used for multiplicity adjustment of the coprimary and a subset of secondary efficacy endpoints to maintain the overall significance level at 0.05.|Cox proportional hazards|Cox proportional hazards model adjusting for age and prevalent vertebral fracture stratification variables.|Hazard ratio \< 1 favors romosozumab.|||1.35|0.22|0.18
72585023|NCT01575834|144701441|SUPERIORITY||Hazard Ratio (HR)|0.5||||0.12|TWO_SIDED|95.0|0.24|1.04||A fixed-sequence testing procedure was used for multiplicity adjustment of the coprimary and a subset of secondary efficacy endpoints to maintain the overall significance level at 0.05.|Cox proportional hazards|Cox proportional hazards model adjusting for age and prevalent vertebral fracture stratification variables.|Hazard ratio \< 1 favors romosozumab.|||1.04|0.24|0.12
72585024|NCT01575834|144701442|SUPERIORITY||Hazard Ratio (HR)|0.6||||0.012|TWO_SIDED|95.0|0.4|0.9|||Cox proportional hazards|Cox proportional hazards model adjusting for age and prevalent vertebral fracture stratification variables.|Hazard ratio \< 1 favors romosozumab.|||0.90|0.40|0.012
72585025|NCT01575834|144701443|SUPERIORITY||Hazard Ratio (HR)|0.62||||0.002|TWO_SIDED|95.0|0.46|0.84|||Cox proportional hazards|Cox proportional hazards model adjusting for age and prevalent vertebral fracture stratification variables.|Hazard ratio \< 1 favors romosozumab.|||0.84|0.46|0.002
72585026|NCT01575834|144701444|SUPERIORITY||Odds Ratio (OR)|0.11||||0.011|TWO_SIDED|95.0|0.01|0.87|||Regression, Logistic|Based on logistic regression model adjusted for age and prevalent vertebral fracture stratification variables; p-value based on score test.|Values \< 1 for odds ratio favor romosozumab.|||0.87|0.01|0.011
72552236|NCT00834743|144635218|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|99.49||||||90.0|90.65|109.18|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||109.18|90.65|
72552237|NCT00834743|144635219|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|99.0||||||90.0|91.44|107.19|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||107.19|91.44|
72552238|NCT00834743|144635220|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|99.05||||||90.0|90.57|108.32|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||108.32|90.57|
72552239|NCT04274686|144635236|SUPERIORITY||Mean Difference (Final Values)|1.9||||0.667|TWO_SIDED|95.0|-7.0|10.7|||Paired t-test|||Null hypothesis: No difference in percent air leakage||10.7|-7.0|0.667
72552240|NCT04274686|144635237|SUPERIORITY||Mean Difference (Final Values)|1.1||||0.218|TWO_SIDED|95.0|-0.7|2.9|||Paired t-test|||||2.90|-0.70|0.218
72552241|NCT04274686|144635238|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.455|TWO_SIDED|95.0|-0.5|0.2|||Paired t-test|||||0.2|-0.5|0.455
72552242|NCT00376623|144635239|OTHER|A one-sided exact binomial test with a 2.5 % significance level was used to detect the difference between BI 2536 and historical placebo with objective response rate = 0.9 % (two out of 211) with a 95 % confidence interval of 0.2 % to 3 %.||||||0.0548|||||||One-sided exact binomial test|Null hypothesis H0: p \<= 0.009 Alternative hypothesis HA: p \> 0.009||Efficacy of BI 2536 was evaluated by comparing the tumour response rate of the present trial with the tumour response rate published for patients with the same stage of disease treated with placebo. For this, treatment groups 'BI 2536 200 mg' and 'combination of treatment group 50 mg BI 2536 (day 1 - day 3) and 60 mg BI 2536 (day 1 - day 3)' were pooled together and compared to historical placebo.||||0.0548
72552243|NCT00376623|144635240|OTHER||Hazard Ratio (HR)|1.02||||0.92|TWO_SIDED|95.0|0.67|1.55|||Log Rank||"Hazard ratio calculated as Combination of 50 mg BI 2536 and 60 mg BI 2536 divided by 200 mg BI 2536"|Exploratory analysis. No formal hypotheses were tested.||1.55|0.67|0.92
72552244|NCT00376623|144635241|OTHER||Hazard Ratio (HR)|1.11||||0.65|TWO_SIDED|95.0|0.7|1.78|||Log Rank||"Hazard ratio calculated as Combination of 50 mg BI 2536 and 60 mg BI 2536 divided by 200 mg BI 2536"|Exploratory analysis. No formal hypotheses were tested.||1.78|0.7|0.65
72552245|NCT00376623|144635244|OTHER|Exploratory analysis. No formal hypotheses were tested.|Hazard Ratio (HR)|1.54|||||TWO_SIDED|95.0|0.94|2.51|||Regression, Cox||"Hazard ratio calculated as Combination of 50 mg BI 2536 and 60 mg BI 2536 divided by 200 mg BI 2536"|||2.51|0.94|
72552246|NCT00376623|144635245|OTHER|Exploratory analysis. No formal hypotheses were tested.|Hazard Ratio (HR)|0.94|||||TWO_SIDED|95.0|0.59|1.49|||Regression, Cox||"Hazard ratio calculated as Combination of 50 mg BI 2536 and 60 mg BI 2536 divided by 200 mg BI 2536"|||1.49|0.59|
72585027|NCT01575834|144701445|SUPERIORITY||Odds Ratio (OR)|0.06|||<|0.001|TWO_SIDED|95.0|0.01|0.44|||Regression, Logistic|Based on logistic regression model adjusted for age and prevalent vertebral fracture stratification variables; p-value based on score test.|Values \< 1 for odds ratio favor romosozumab.|||0.44|0.01|< 0.001
72552247|NCT00376623|144635246|OTHER|Exploratory analysis. No formal hypotheses were tested.|Hazard Ratio (HR)|1.27|||||TWO_SIDED|95.0|0.81|2.01|||Regression, Cox||"Hazard ratio calculated as Combination of 50 mg BI 2536 and 60 mg BI 2536 divided by 200 mg BI 2536"|||2.01|0.81|
72552248|NCT00286754|144635255|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED|||||BP control and SBP were compared at 6 months across treatment arms using a Bonferroni adjustment of 1.25% for each of the 4 comparisons (SMI versus UC and HEI versus UC for BP control and SBP separately). This p-value is for comparison of SMI vs. UC|Wilcoxon (Mann-Whitney)|||The study was an effectiveness trial of 2 active interventions, each compared with an active standard of care control group. We expected that 54% of patients on BP-lowering therapy would be properly controlled with HEI and 43% with UC, whereas we expected SMI to increase this to 69% control in 6 months. BP control and SBP were compared at 6 months across treatment arms using a 2.5% type I error (Bonferroni adjustment), ie, 1.25% for each of the 4 comparisons.||||0.001
72552249|NCT00286754|144635255|SUPERIORITY_OR_OTHER|||||||0.108|TWO_SIDED|||||BP control and SBP were compared at 6 months across treatment arms using a Bonferroni adjustment of 1.25% for each of the 4 comparisons (SMI versus UC and HEI versus UC for BP control and SBP separately). This p-value is for comparison of HEI vs. UC|Wilcoxon (Mann-Whitney)|||||||0.108
72552250|NCT00286754|144635256|SUPERIORITY_OR_OTHER|||||||0.009|TWO_SIDED|||||BP control and SBP were compared at 6 months across treatment arms using a 2.5% type I error (Bonferroni adjustment), 1.25% for each of the 4 comparisons (SMI versus UC and HEI vs UC for BP control and SBP separately). This p-value is for SMI vs UC|Wilcoxon (Mann-Whitney)|||The study was designed as an effectiveness trial of 2 active interventions, each compared with an active standard of care control group. The study was not powered to test comparisons between the 2 active intervention arms.||||0.009
72552251|NCT00286754|144635256|SUPERIORITY_OR_OTHER|||||||0.047|TWO_SIDED|||||BP control and SBP were compared at 6 months across treatment arms using a Bonferroni adjustment of 1.25% for each of the 4 comparisons (SMI versus UC and HEI vs UC for BP control and SBP separately). This p-value is for comparison of HEI vs. UC|Wilcoxon (Mann-Whitney)|||||||0.047
72585028|NCT01575834|144701446|SUPERIORITY||LS Mean Difference|12.7|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|12.4|12.9|||ANCOVA|||The treatment comparison of BMD at the lumbar spine was analyzed using an analysis of covariance (ANCOVA) model which included treatment, age and prevalent vertebral fracture stratification variables, and baseline value of the endpoint, machine type and machine type-by-baseline value interaction.||12.9|12.4|< 0.001
72413576|NCT02099838|144336170|SUPERIORITY_OR_OTHER|||||||0.1248||||||The a priori threshold for statistical significance is 0.05; the change was statistical significant with P-value less than 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in change of LDL between before and after treatment in Placebo group. The test was performed with a significance level of 0.05.||||0.1248
72413577|NCT02099838|144336170|SUPERIORITY_OR_OTHER|||||||0.362||||||The a priori threshold for statistical significance is 0.05; the change was statistical significant with P-value less than 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in change of LDL between Pioglitazone and Metformin group and Placebo group. The test was performed with a significance level of 0.05.||||0.3620
72413578|NCT02099838|144336171|SUPERIORITY_OR_OTHER|||||||0.5636||||||The a priori threshold for statistical significance is 0.05; the change was statistical significant with P-value less than 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in change of ALT between before and after treatment in Pioglitazone and Metformin group. The test was performed with a significance level of 0.05.||||0.5636
72413579|NCT02099838|144336171|SUPERIORITY_OR_OTHER|||||||0.3681||||||The a priori threshold for statistical significance is 0.05; the change was statistical significant with P-value less than 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in change of ALT between before and after treatment in Placebo group. The test was performed with a significance level of 0.05.||||0.3681
72413580|NCT02099838|144336171|SUPERIORITY_OR_OTHER|||||||0.2589||||||The a priori threshold for statistical significance is 0.05; the change was statistical significant with P-value less than 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in change of ALT between Pioglitazone and Metformin group and Placebo group. The test was performed with a significance level of 0.05.||||0.2589
72413581|NCT02099838|144336172|SUPERIORITY_OR_OTHER|||||||0.7972||||||The a priori threshold for statistical significance is 0.05; the change was statistical significant with P-value less than 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in change of AST between before and after treatment in Pioglitazone and Metformin group. The test was performed with a significance level of 0.05.||||0.7972
72552252|NCT00286754|144635257|SUPERIORITY_OR_OTHER||||||<|3e-06|TWO_SIDED|||||Change in BP control were compared by treatment arm using a 1.67% type I error (with Bonferroni adjustment), ie, 1.67% for each assessment of change in proportion with BP under control from baseline to 6 months by SMI, HEI or UC (3 tests).|McNemar|||||||<0.000003
72552253|NCT00286754|144635257|SUPERIORITY_OR_OTHER|||||||0.012|TWO_SIDED|||||Change in BP control were compared by treatment arm using a 1.67% type I error (with Bonferroni adjustment), ie, 1.67% for each assessment of change in proportion with BP under control from baseline to 6 months by SMI, HEI or UC (3 tests).|McNemar|||||||0.012
72552254|NCT00286754|144635257|SUPERIORITY_OR_OTHER|||||||0.89|TWO_SIDED|||||Change in BP control were compared by treatment arm using a 1.67% type I error (with Bonferroni adjustment), ie, 1.67% for each assessment of change in proportion with BP under control from baseline to 6 months by SMI, HEI or UC (3 tests).|McNemar|||||||0.89
72552255|NCT00286754|144635258|SUPERIORITY_OR_OTHER||||||<|0.009|TWO_SIDED|||||Change in SBP were compared by treatment arm using a 1.67% type I error (Bonferroni adjustment), ie, 1.67% for each of the 3 comparisons by arm (6-month-baseline for SMI, HEI and UC separately).|Wilcoxon (Mann-Whitney)|||||||<0.009
72552256|NCT00286754|144635258|SUPERIORITY_OR_OTHER|||||||0.008|TWO_SIDED|||||Change in SBP were compared by treatment arm using a 1.67% type I error (Bonferroni adjustment), ie, 1.67% for each of the 3 comparisons by arm (6-month-baseline for SMI, HEI and UC separately).|Wilcoxon (Mann-Whitney)|||||||0.008
72552257|NCT00286754|144635258|SUPERIORITY_OR_OTHER|||||||0.9|TWO_SIDED|||||Change in SBP were compared by treatment arm using a 1.67% type I error (Bonferroni adjustment), ie, 1.67% for each of the 3 comparisons by arm (6-month-baseline for SMI, HEI and UC separately).|Wilcoxon (Mann-Whitney)|||||||0.9
72552258|NCT00286754|144635259|SUPERIORITY_OR_OTHER|||||||0.88|TWO_SIDED|||||Since we are performing 3 tests, we will adjust the type I error to 0.017|Wilcoxon (Mann-Whitney)|||||||0.880
72552259|NCT00286754|144635259|SUPERIORITY_OR_OTHER|||||||0.318|TWO_SIDED|||||Change in SBP were compared by treatment arm using a 1.67% type I error (Bonferroni adjustment), ie, 1.67% for each of the 3 comparisons by arm (6-month-baseline for SMI, HEI and UC separately).|Wilcoxon (Mann-Whitney)|||||||0.318
72552260|NCT00286754|144635260|SUPERIORITY_OR_OTHER|||||||0.306|TWO_SIDED|||||Since we are performing 3 tests, we will adjust the type I error to 0.017|Wilcoxon (Mann-Whitney)|||||||0.306
72552261|NCT00286754|144635260|SUPERIORITY_OR_OTHER|||||||0.205|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.205
72552262|NCT00286754|144635261|SUPERIORITY_OR_OTHER|||||||0.011|TWO_SIDED|||||Since we are performing 3 tests, we will adjust the type I error to 0.017|Chi-squared|||||||0.011
72552263|NCT00286754|144635261|SUPERIORITY_OR_OTHER|||||||0.638|TWO_SIDED|||||Since we are performing 3 tests, we will adjust the type I error to 0.017|Chi-squared|||||||0.638
72552264|NCT00286754|144635262|SUPERIORITY_OR_OTHER|||||||0.012|TWO_SIDED|||||Since we are performing 3 tests, we will adjust the type I error to 0.017|Chi-squared|||||||0.012
72413582|NCT02099838|144336172|SUPERIORITY_OR_OTHER|||||||0.7801||||||The a priori threshold for statistical significance is 0.05; the change was statistical significant with P-value less than 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in change of AST between before and after treatment in Placebo group. The test was performed with a significance level of 0.05.||||0.7801
72413583|NCT02099838|144336172|SUPERIORITY_OR_OTHER|||||||0.8744||||||The a priori threshold for statistical significance is 0.05; the change was statistical significant with P-value less than 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in change of AST between Pioglitazone and Metformin group and Placebo group. The test was performed with a significance level of 0.05.||||0.8744
72413584|NCT02099838|144336173|SUPERIORITY_OR_OTHER|||||||0.8034||||||The a priori threshold for statistical significance is 0.05; the change was statistical significant with P-value less than 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in change of DBil between before and after treatment in Pioglitazone and Metformin group. The test was performed with a significance level of 0.05.||||0.8034
72585029|NCT01575834|144701447|SUPERIORITY||LS Mean Difference|11.1|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|10.8|11.4|||ANCOVA|||The treatment comparison of BMD at the lumbar spine was analyzed using an analysis of covariance (ANCOVA) model which included treatment, age and prevalent vertebral fracture stratification variables, and baseline value of the endpoint, machine type and machine type-by-baseline value interaction.||11.4|10.8|< 0.001
72585030|NCT01575834|144701448|SUPERIORITY||LS Mean Difference|5.8|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|5.6|6.0|||ANCOVA|||The treatment comparison of BMD at the total hip was analyzed using an ANCOVA model which included treatment, age and prevalent vertebral fracture stratification variables, and baseline value of the endpoint, machine type and machine type-by-baseline value interaction.||6.0|5.6|< 0.001
72585031|NCT01575834|144701449|SUPERIORITY||LS Mean Difference|5.3|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|5.1|5.5|||ANCOVA|||The treatment comparison of BMD at the total hip was analyzed using an ANCOVA model which included treatment, age and prevalent vertebral fracture stratification variables, and baseline value of the endpoint, machine type and machine type-by-baseline value interaction.||5.5|5.1|< 0.001
72585032|NCT01575834|144701450|SUPERIORITY||LS Mean Difference|5.2|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|4.9|5.4|||ANCOVA|||The treatment comparison of BMD at the femoral neck was analyzed using an ANCOVA model which included included treatment, age and prevalent vertebral fracture stratification variables, and baseline value of the endpoint, machine type and machine type-by-baseline value interaction.||5.4|4.9|< 0.001
72413585|NCT02099838|144336173|SUPERIORITY_OR_OTHER|||||||0.7675||||||The a priori threshold for statistical significance is 0.05; the change was statistical significant with P-value less than 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in change of TBil between before and after treatment in Placebo group. The test was performed with a significance level of 0.05.||||0.7675
72413586|NCT02099838|144336173|SUPERIORITY_OR_OTHER|||||||0.6918||||||The a priori threshold for statistical significance is 0.05; the change was statistical significant with P-value less than 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in change of TBil between Pioglitazone and Metformin group and Placebo group. The test was performed with a significance level of 0.05.||||0.6918
72413587|NCT02099838|144336174|SUPERIORITY_OR_OTHER|||||||0.0339||||||The a priori threshold for statistical significance is 0.05; the change was statistical significant with P-value less than 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in change of DBil between before and after treatment in Pioglitazone and Metformin group. The test was performed with a significance level of 0.05.||||0.0339
72413588|NCT02099838|144336174|SUPERIORITY_OR_OTHER|||||||0.0997||||||The a priori threshold for statistical significance is 0.05; the change was statistical significant with P-value less than 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in change of DBil between before and after treatment in Placebo group. The test was performed with a significance level of 0.05.||||0.0997
72413589|NCT02099838|144336174|SUPERIORITY_OR_OTHER|||||||0.5015||||||The a priori threshold for statistical significance is 0.05; the change was statistical significant with P-value less than 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in change of DBil between Pioglitazone and Metformin group and Placebo group. The test was performed with a significance level of 0.05.||||0.5015
72552265|NCT00286754|144635262|SUPERIORITY_OR_OTHER|||||||0.333|TWO_SIDED|||||Since we are performing 3 tests, we will adjust the type I error to 0.017|Chi-squared|||||||0.333
72552266|NCT00286754|144635263|SUPERIORITY_OR_OTHER|||||||0.581|TWO_SIDED|||||Since we are performing 3 tests, we will adjust the type I error to 0.017|Chi-squared|||||||0.581
72552267|NCT00286754|144635263|SUPERIORITY_OR_OTHER|||||||0.502|TWO_SIDED|||||Since we are performing 3 tests, we will adjust the type I error to 0.017|Chi-squared|||||||0.502
72552268|NCT01054586|144635275|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|6.1||||0.02||95.0|1.26|29.46||Only variables showing an imbalance between the treatment groups (when possible and besides APRI score) were included. The following were also included, but p \> 0.05: APRI score, use of non-ARV drug, baseline CD4, platelets, and bilirubin.|Regression, Cox||"Confidence Interval and Hazard Ratio for ART naïve. Not ART naïve is the reference group."|||29.46|1.26|0.02
72585033|NCT01575834|144701451|SUPERIORITY||LS Mean Difference|4.9|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|4.7|5.2|||ANCOVA|||The treatment comparison of BMD at the femoral neck was analyzed using an ANCOVA model which included included treatment, age and prevalent vertebral fracture stratification variables, and baseline value of the endpoint, machine type and machine type-by-baseline value interaction.||5.2|4.7|< 0.001
72585034|NCT03858998|144701464|SUPERIORITY||Risk Difference (RD)|0.004||||0.91|TWO_SIDED|95.0|-0.06|0.07|||Chi-squared||Direction = Linkage minus SOC|||0.07|-0.06|0.91
72585035|NCT02220764|144701478|SUPERIORITY_OR_OTHER|||||||0.03|TWO_SIDED||||||Log Rank|||Null hypothesis: The chipping rates between tooth- and implant- supoorted FDPs are equally distributed.||||0.03
72585036|NCT05000164|144701480|SUPERIORITY||Least-square Mean|-0.12|STANDARD_ERROR_OF_MEAN|0.02|||TWO_SIDED|95.0|-0.17|-0.07|||Mixed Models Analysis|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.|The upper limit of each 95% confidence interval was compared to 0.0 logMAR for distance.|Distance (4m)||-0.07|-0.17|
72413590|NCT03740490|144336187|SUPERIORITY||Mean Difference (Net)|-0.1||||0.284|TWO_SIDED|95.0|-0.28|0.08|||Mixed Models Analysis|||Each outcome was modeled using a mixed-effects regression with the change score as the dependent variable and treatment group (Smart-T vs. QuitGuide) as the predictor, restricted to participants who received or would have received that type of message.||0.08|-0.28|0.284
72413591|NCT03740490|144336188|SUPERIORITY||Mean Difference (Net)|0.06||||0.477|TWO_SIDED|95.0|-0.11|0.24|||Mixed Models Analysis|||||0.24|-0.11|0.477
72413592|NCT03740490|144336189|SUPERIORITY||Mean Difference (Net)|0.03||||0.456|TWO_SIDED|95.0|-0.05|0.1|||Mixed Models Analysis|||||0.10|-0.05|0.456
72413593|NCT03740490|144336190|SUPERIORITY||Mean Difference (Net)|-0.22||||0.215|TWO_SIDED|95.0|-0.56|0.13|||Mixed Models Analysis|||||0.13|-0.56|0.215
72552269|NCT01054586|144635276|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|4.12||||0.05||95.0|1.03|16.5||Only variables showing an imbalance between the treatment groups (when possible and besides APRI score) were included. The following were also included, but p \> 0.05: APRI score, use of non-ARV drug, baseline CD4, platelets, and bilirubin.|Regression, Cox||"Confidence Interval and Hazard Ratio for FPV 700 mg BID/RTV 100 mg BID. LPV is the reference group."|||16.50|1.03|0.05
72552270|NCT01054586|144635276|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.62||||0.68||95.0|0.16|16.27||Only variables showing an imbalance between the treatment groups (when possible and besides APRI score) were included. The following were also included, but p \> 0.05: APRI score, use of non-ARV drug, baseline CD4, platelets, and bilirubin.|Regression, Cox||"Confidence Interval and Hazard Ratio for FPV 700 mg BID/RTV 100 mg QD. LPV is the reference group."|||16.27|0.16|0.68
72585037|NCT05000164|144701480|SUPERIORITY||Least-square Mean|-0.01|STANDARD_ERROR_OF_MEAN|0.022|||TWO_SIDED|95.0|-0.06|0.04|||Mixed Models Analysis|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.|The upper limit of each 95% confidence interval was compared to 0.17 logMAR for intermediate.|Intermediate (64cm)||0.04|-0.06|
72585038|NCT05000164|144701480|SUPERIORITY||Least-square Mean|0.09|STANDARD_ERROR_OF_MEAN|0.024|||TWO_SIDED|95.0|0.04|0.15|||Mixed Models Analysis|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.|The upper limit of each 95% confidence interval was compared to 0.17 logMAR for near.|Near (40cm)||0.15|0.04|
72585039|NCT06509438|144701488|OTHER|Compare 4 weeks after the last injection to baseline|Difference of medians|-0.45|||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<0.001
72585040|NCT06509438|144701488|OTHER|Compare 12 weeks after the last injection to baseline|Difference of medians|-0.4|||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<0.001
72585041|NCT03331796|144701492|SUPERIORITY||Mean Difference (Final Values)|1.5|STANDARD_ERROR_OF_MEAN|3.1||0.63|TWO_SIDED|95.0|-4.8|7.9|||Regression, Linear|Adjusted for baseline||||7.9|-4.8|0.63
72585042|NCT03331796|144701492|SUPERIORITY||Mean Difference (Final Values)|6.9|STANDARD_ERROR_OF_MEAN|3.3||0.0476|TWO_SIDED|95.0|0.1|13.7|||Regression, Linear|||||13.7|0.1|0.0476
72585043|NCT03331796|144701493|SUPERIORITY||Mean Difference (Final Values)|-3.1|STANDARD_ERROR_OF_MEAN|4.1||0.45|TWO_SIDED|95.0|-11.4|5.2|||Regression, Linear|Adjusted for baseline||a priori threshold for statistical significance = .05||5.2|-11.4|0.45
72585044|NCT03331796|144701493|SUPERIORITY||Mean Difference (Final Values)|5.7|STANDARD_ERROR_OF_MEAN|4.4||0.21|TWO_SIDED|95.0|-3.3|14.8|||Regression, Linear|Adjusted for baseline||a priori threshold for statistical significance = .05||14.8|-3.3|0.21
72585045|NCT03331796|144701494|SUPERIORITY||Mean Difference (Final Values)|0.42|STANDARD_ERROR_OF_MEAN|0.38||0.29|TWO_SIDED|95.0|-0.36|1.19|||Regression, Linear|Adjusted for baseline||a priori threshold for statistical significance = .05||1.19|-0.36|0.29
72585046|NCT03331796|144701494|SUPERIORITY||Mean Difference (Final Values)|0.27|STANDARD_ERROR_OF_MEAN|0.4||0.51|TWO_SIDED|95.0|-0.55|1.08|||Regression, Linear|Adjusted for baseline||a priori threshold for statistical significance = .05||1.08|-0.55|0.51
72585047|NCT03331796|144701495|SUPERIORITY||Mean Difference (Final Values)|1.0|STANDARD_ERROR_OF_MEAN|1.0||0.33|TWO_SIDED|95.0|-1.0|3.0|||Regression, Linear|Adjusted for baseline||a priori threshold for statistical significance = .05||3.0|-1.0|.33
72585048|NCT03331796|144701495|SUPERIORITY||Mean Difference (Final Values)|3.2|STANDARD_ERROR_OF_MEAN|1.0||0.0038|TWO_SIDED|95.0|1.1|5.3|||Regression, Linear|Adjusted for baseline||a priori threshold for statistical significance = .05||5.3|1.1|0.0038
72413594|NCT00823719|144336206|SUPERIORITY_OR_OTHER||percentage of participants|69.0|||||TWO_SIDED|95.0|48.2|85.7|||||The estimated value represents the percentage of participants with OR for participants receiving Ofatumumab + DHAP treatment.|||85.7|48.2|
72413595|NCT00823719|144336206|SUPERIORITY_OR_OTHER||percentage of participants|55.0|||||TWO_SIDED|95.0|36.4|71.9|||||The estimated value represents the percentage of participants with OR for participants receiving Ofatumumab + ICE treatment.|||71.9|36.4|
72585049|NCT03331796|144701496|SUPERIORITY||Mean Difference (Final Values)|0.44|STANDARD_ERROR_OF_MEAN|0.78||0.58|TWO_SIDED|95.0|-1.1|2.0|||Regression, Linear|Adjusted for baseline||a priori threshold for statistical significance = .05||2.0|-1.1|0.58
72585050|NCT03331796|144701496|SUPERIORITY||Mean Difference (Final Values)|-0.46|STANDARD_ERROR_OF_MEAN|0.86||0.59|TWO_SIDED|95.0|-2.2|1.3|||Regression, Linear|Adjusted for baseline||||1.3|-2.2|0.59
72585051|NCT03331796|144701497|SUPERIORITY||Mean Difference (Final Values)|5.5|STANDARD_ERROR_OF_MEAN|5.2||0.3|TWO_SIDED|95.0|-5.2|16.1|||Regression, Linear|Adjusted for baseline||a priori threshold for statistical significance = .05||16.1|-5.2|0.30
72585052|NCT03331796|144701497|SUPERIORITY||Mean Difference (Final Values)|-4.8|STANDARD_ERROR_OF_MEAN|4.9||0.34|TWO_SIDED|95.0|-14.9|5.3|||Regression, Linear|Adjusted for baseline||a priori threshold for statistical significance = .05||5.3|-14.9|0.34
72585053|NCT03331796|144701498|SUPERIORITY||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|10.6||0.996|TWO_SIDED|95.0|-22.0|22.1|||Regression, Linear|Adjusted for baseline||a priori threshold for statistical significance = .05||22.1|-22.0|0.996
72585054|NCT03331796|144701498|SUPERIORITY||Mean Difference (Final Values)|1.8|STANDARD_ERROR_OF_MEAN|10.8||0.87|TWO_SIDED|95.0|-20.6|24.3|||Regression, Linear|Adjusted for baseline||a priori threshold for statistical significance = .05||24.3|-20.6|0.87
72585055|NCT03331796|144701499|SUPERIORITY||Mean Difference (Final Values)|0.04|STANDARD_ERROR_OF_MEAN|1.06||0.97|TWO_SIDED|95.0|-2.14|2.22|||Regression, Linear|Adjusted for baseline||a priori threshold for statistical significance = .05||2.22|-2.14|0.97
72585056|NCT03331796|144701499|SUPERIORITY||Mean Difference (Final Values)|0.13|STANDARD_ERROR_OF_MEAN|1.11||0.91|TWO_SIDED|95.0|-2.15|2.41|||Regression, Linear|Adjusted for baseline||a priori threshold for statistical significance = .05||2.41|-2.15|0.91
72413596|NCT00823719|144336206|SUPERIORITY_OR_OTHER||percentage of participants|61.0|||||TWO_SIDED|95.0|47.4|73.5|||||The estimated value represents the percentage of participants with OR for participants receiving Total Ofatumumab + Chemotherapy treatment.|||73.5|47.4|
72413597|NCT02896855|144336267|OTHER||Stratified Hazard Ratio|0.69||||0.0418|TWO_SIDED|95.0|0.49|0.99|||Log Rank|A two-sided log-rank test was used, stratified by disease type and hormone-receptor status.|This stratified Hazard Ratio (HR) is calculated as Arm B: Pertuzumab versus Arm A: Placebo. Cox proportional hazards model, stratified by disease type and hormone-receptor status, was used to estimate HR and its 95% CI.|This was for the primary analysis. Hypothesis testing is considered exploratory in this bridging study.||0.99|0.49|0.0418
72552271|NCT01054586|144635277|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.83||||0.17||95.0|0.65|12.36||Only variables showing an imbalance between the treatment groups (when possible) were included. The following were also included, but p \> 0.05: APRI score, use of non-ARV drug, baseline CD4, platelets, and bilirubin.|Regression, Cox||"Confidence Interval and Hazard Ratio for FPV 700 mg BID/RTV 100 mg BID. LPV is the reference group."|||12.36|0.65|0.17
72413598|NCT02896855|144336267|OTHER||Unstratified Hazard Ratio|0.71||||0.0556|TWO_SIDED|95.0|0.5|1.01|||Log Rank|This two-sided log-rank test was unstratified.|This unstratified Hazard Ratio (HR) is calculated as Arm B: Pertuzumab versus Arm A: Placebo. Cox proportional hazards model was used to estimate HR and its 95% CI.|This was for the primary analysis. Hypothesis testing is considered exploratory in this bridging study.||1.01|0.50|0.0556
72552272|NCT01054586|144635277|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.26||||0.85||95.0|0.12|13.33||Only variables showing an imbalance between the treatment groups (when possible) were included. The following were also included, but p \> 0.05: APRI score, use of non-ARV drug, baseline CD4, platelets, and bilirubin.|Regression, Cox||"Confidence Interval and Hazard Ratio for FPV 700 mg BID/RTV 100 mg QD. LPV is the reference group."|||13.33|0.12|0.85
72552273|NCT01054586|144635278|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|3.2||||0.06||95.0|0.94|10.82||Only variables showing an imbalance between the treatment groups (when possible and besides APRI score) were included. The following were also included, but p \> 0.05: APRI score, use of non-ARV drug, baseline CD4, platelets, and bilirubin.|Regression, Cox||"Confidence Interval and Hazard Ratio for FPV 700 mg BID/RTV 100 mg BID. LPV is the reference group."|||10.82|0.94|0.06
72552274|NCT01054586|144635278|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.06||||0.96||95.0|0.11|9.83||Only variables showing an imbalance between the treatment groups (when possible and besides APRI score) were included. The following were also included, but p \> 0.05: APRI score, use of non-ARV drug, baseline CD4, platelets, and bilirubin.|Regression, Cox||"Confidence Interval and Hazard Ratio for FPV 700 mg BID/RTV 100 mg QD. LPV is the reference group."|||9.83|0.11|0.96
72552275|NCT01054586|144635279|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.31||||0.57||95.0|0.52|3.31||Variables showing imbalance between treatments (when possible and besides APRI score) were included. Gender, mode of HIV transmission, ART naive, APRI score, use of non-ARV drug, baseline CD4, platelets, and bilirubin were also included, but p\>0.05.|Regression, Cox||"Confidence Interval and Hazard Ratio for FPV 700 mg BID/RTV 100 mg BID. LPV is the reference group."|||3.31|0.52|0.57
72552276|NCT01054586|144635279|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.28||||0.22||95.0|0.04|2.14||Variables showing imbalance between treatments (when possible and besides APRI score) were included. Gender, mode of HIV transmission, ART naive, APRI score, use of non-ARV drug, baseline CD4, platelets, and bilirubin were also included, but p\>0.05.|Regression, Cox||"Confidence Interval and Hazard Ratio for FPV 700 mg BID/RTV 100 mg QD. LPV is the reference group."|||2.14|0.04|0.22
72552277|NCT01054586|144635279|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.86||||0.47||95.0|0.35|9.91||Variables showing imbalance between treatments (when possible and besides APRI score) were included. Gender, mode of HIV transmission, ART naive, APRI score, use of non-ARV drug, baseline CD4, platelets, and bilirubin were also included, but p\>0.05.|Regression, Cox||"Confidence Interval and Hazard Ratio for FPV, Other. LPV is the reference group."|||9.91|0.35|0.47
72552278|NCT01054586|144635280|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.4||||0.48||95.0|0.55|3.55||Only variables showing imbalance between treatments (when possible) were included. The following were also included, but p \> 0.05: gender, mode of HIV transmission, ART naive, APRI score, use of non-ARV drug, baseline CD4, platelets, and bilirubin.|Regression, Cox||"Confidence Interval and Hazard Ratio for FPV 700 mg BID/RTV 100 mg BID. LPV is the reference group."|||3.55|0.55|0.48
72552279|NCT01054586|144635280|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.26||||0.23||95.0|0.03|2.18||Only variables showing imbalance between treatments (when possible) were included. The following were also included, but p \> 0.05: gender, mode of HIV transmission, ART naive, APRI score, use of non-ARV drug, baseline CD4, platelets, and bilirubin.|Regression, Cox||"Confidence Interval and Hazard Ratio for FPV 700 mg BID/RTV 100 mg QD. LPV is the reference group."|||2.18|0.03|0.23
72552280|NCT01054586|144635280|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.67||||0.56||95.0|0.29|9.47||Only variables showing imbalance between treatments (when possible) were included. The following were also included, but p \> 0.05: gender, mode of HIV transmission, ART naive, APRI score, use of non-ARV drug, baseline CD4, platelets, and bilirubin.|Regression, Cox||"Confidence Interval and Hazard Ratio for FPV, Other. LPV is the reference group."|||9.47|0.29|0.56
72552281|NCT01054586|144635282|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.16||||0.72||95.0|0.51|2.66||Only variables showing an imbalance between treatment groups were included: gender, mode of HIV transmission, ART naive, use of non-ARV drug, baseline bilirubin.|Regression, Cox||"Confidence Interval and Hazard Ratio for  FPV 700 mg BID/RTV 100 mg BID. LPV is the reference group."|||2.66|0.51|0.72
72552282|NCT01054586|144635282|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.27||||0.21||95.0|0.03|2.08||Only variables showing an imbalance between treatment groups were included: gender, mode of HIV transmission, ART naive, use of non-ARV drug, baseline bilirubin.|Regression, Cox||"Confidence Interval and Hazard Ratio for  FPV 700 mg BID/RTV 100 mg QD. LPV is the reference group."|||2.08|0.03|0.21
72552283|NCT01054586|144635282|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.26||||0.15||95.0|0.74|6.97|||Regression, Cox||"Confidence Interval and Hazard Ratio for  FPV, other. LPV is the reference group."|Only variables showing an imbalance between treatment groups were included: gender, mode of HIV transmission, ART naive, use of non-ARV drug, baseline bilirubin.||6.97|0.74|0.15
72552284|NCT01054586|144635288|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|3.77||||0.1||95.0|0.79|18.05|||Regression, Cox||"Confidence Interval and Hazard Ratio for  FPV 700 mg BID/RTV 100 mg BID. LPV is the reference group."|||18.05|0.79|0.10
72552285|NCT01054586|144635289|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.53||||0.02||95.0|1.16|5.54||Only variables showing an imbalance between the treatment groups were included, but p \> .05: gender, mode of HIV transmission, ART naive, APRI score, baseline use of non-ARV drug, and baseline values of CD4, platelets and bilirubin.|Regression, Cox||"Confidence Interval and Hazard Ratio for  FPV 700 mg BID/RTV 100 mg BID. LPV is the reference group."|||5.54|1.16|0.02
72552286|NCT01054586|144635289|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|4.17||||0.05||95.0|1.54|11.27||Only variables showing an imbalance between the treatment groups were included, but p \> .05: gender, mode of HIV transmission, ART naive, APRI score, baseline use of non-ARV drug, and baseline values of CD4, platelets and bilirubin.|Regression, Cox||"Confidence Interval and Hazard Ratio for  FPV 700 mg BID/RTV 100 mg QD. LPV is the reference group."|||11.27|1.54|0.05
72585057|NCT03331796|144701500|SUPERIORITY||Mean Difference (Final Values)|-0.22|STANDARD_DEVIATION|1.0||0.84|TWO_SIDED|95.0|-2.3|1.9|||Regression, Linear|Adjusted for baseline||a priori threshold for statistical significance = .05||1.9|-2.3|0.84
72585058|NCT03331796|144701500|SUPERIORITY||Mean Difference (Final Values)|0.27|STANDARD_ERROR_OF_MEAN|1.0||0.8|TWO_SIDED|95.0|-1.9|2.4|||Regression, Linear|Adjusted for baseline||a priori threshold for statistical significance = .05||2.4|-1.9|0.80
72413599|NCT02896855|144336267|OTHER||Stratified Hazard Ratio|0.6||||0.0008|TWO_SIDED|95.0|0.45|0.81|||Log Rank|A two-sided log-rank test was used, stratified by disease type and hormone-receptor status.|This stratified Hazard Ratio (HR) is calculated as Arm B: Pertuzumab versus Arm A: Placebo. Cox proportional hazards model, stratified by disease type and hormone-receptor status, was used to estimate HR and its 95% CI.|This was for the final analysis. Hypothesis testing is considered exploratory in this bridging study.||0.81|0.45|0.0008
72413600|NCT02896855|144336267|OTHER||Unstratified Hazard Ratio|0.63||||0.0019|TWO_SIDED|95.0|0.47|0.85|||Log Rank|This two-sided log-rank test was unstratified.|This unstratified Hazard Ratio (HR) is calculated as Arm B: Pertuzumab versus Arm A: Placebo. Cox proportional hazards model was used to estimate HR and its 95% CI.|This was for the final analysis. Hypothesis testing is considered exploratory in this bridging study.||0.85|0.47|0.0019
72413601|NCT02896855|144336269|OTHER||Stratified Hazard Ratio|0.68||||0.0658|TWO_SIDED|95.0|0.45|1.03|||Log Rank|A two-sided log-rank test was used, stratified by disease type and hormone-receptor status.|This stratified Hazard Ratio (HR) is calculated as Arm B: Pertuzumab versus Arm A: Placebo. Cox proportional hazards model, stratified by disease type and hormone-receptor status, was used to estimate HR and its 95% CI.|Hypothesis testing is considered exploratory in this bridging study.||1.03|0.45|0.0658
72552287|NCT01054586|144635289|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|3.67||||0.06||95.0|0.97|13.9||Only variables showing an imbalance between the treatment groups were included, but p \> .05: gender, mode of HIV transmission, ART naive, APRI score, baseline use of non-ARV drug, and baseline values of CD4, platelets and bilirubin.|Regression, Cox||"Confidence Interval and Hazard Ratio for  FPV, other. LPV is the reference group."|||13.90|0.97|0.06
72552288|NCT01054586|144635290|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.68||||0.01||95.0|1.21|5.9||Only variables showing an imbalance between the treatment groups were included: gender, mode of HIV transmission, ART naive, baseline use of non-ARV drug, and baseline values of CD4, platelets and bilirubin.|Regression, Cox||"Confidence Interval and Hazard Ratio for  FPV 700 mg BID/RTV 100 mg BID. LPV is the reference group."|||5.9|1.21|0.01
72552289|NCT01054586|144635290|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|4.42||||0.0004||95.0|1.61|12.08||Only variables showing an imbalance between the treatment groups were included: gender, mode of HIV transmission, ART naive, baseline use of non-ARV drug, and baseline values of CD4, platelets and bilirubin.|Regression, Cox||"Confidence Interval and Hazard Ratio for  FPV 700 mg BID/RTV 100 mg QD. LPV is the reference group."|||12.08|1.61|0.0004
72552290|NCT01054586|144635290|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|3.07||||0.11||95.0|0.78|12.03||Only variables showing an imbalance between the treatment groups were included: gender, mode of HIV transmission, ART naive, baseline use of non-ARV drug, and baseline values of CD4, platelets and bilirubin.|Regression, Cox||"Confidence Interval and Hazard Ratio for  FPV, other. LPV is the reference group."|||12.03|0.78|0.11
72413602|NCT02896855|144336269|OTHER||Unstratified Hazard Ratio|0.7||||0.0864|TWO_SIDED|95.0|0.46|1.06|||Log Rank|This two-sided log-rank test was unstratified.|This unstratified Hazard Ratio (HR) is calculated as Arm B: Pertuzumab versus Arm A: Placebo. Cox proportional hazards model was used to estimate HR and its 95% CI.|Hypothesis testing is considered exploratory in this bridging study.||1.06|0.46|0.0864
72552291|NCT01054586|144635291|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.09||||0.03||95.0|1.06|4.15||Only variables showing an imbalance between the treatment groups were included: gender, mode of HIV transmission, ART naive, APRI-score, baseline use of non-ARV drug and baseline bilirubin.|Regression, Cox||"Confidence Interval and Hazard Ratio for  FPV 700 mg BID/RTV 100 mg BID. LPV is the reference group."|||4.15|1.06|0.03
72413603|NCT02896855|144336271|OTHER||Difference in Objective Response|9.98||||0.1126|TWO_SIDED|95.0|-2.65|22.6|||Cochran-Mantel-Haenszel|Statistical test is stratified by disease type and hormone receptor status.|The difference in objective response is calculated as Arm B: Pertuzumab minus Arm A: Placebo. 95% CI was calculated using Hauck-Anderson method.|Hypothesis testing is considered exploratory in this bridging study.||22.60|-2.65|0.1126
72552292|NCT01054586|144635291|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|3.61||||0.05||95.0|1.48|8.81||Only variables showing an imbalance between the treatment groups were included: gender, mode of HIV transmission, ART naive, APRI-score, baseline use of non-ARV drug and baseline bilirubin.|Regression, Cox||"Confidence Interval and Hazard Ratio for  FPV 700 mg BID/RTV 100 mg QD. LPV is the reference group."|||8.81|1.48|0.05
72552293|NCT01054586|144635291|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.31||||0.1||95.0|0.85|6.32||Only variables showing an imbalance between the treatment groups were included: gender, mode of HIV transmission, ART naive, APRI-score, baseline use of non-ARV drug and baseline bilirubin.|Regression, Cox||"Confidence Interval and Hazard Ratio for  FPV, other. LPV is the reference group."|||6.32|0.85|0.10
72552294|NCT01054586|144635292|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|5.12||||0.03||95.0|1.19|22.02|||Regression, Cox||"Confidence Interval and Hazard Ratio for  FPV 700 mg BID/RTV 100 mg BID. LPV is the reference group."|||22.02|1.19|0.03
72552295|NCT00910663|144635300|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Geometric Test/Ref Ratio x 100|97.01||||||90.0|90.01|104.55|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||104.55|90.01|
72552296|NCT00910663|144635301|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Geometric Test/Ref Ratio x 100|102.81||||||90.0|100.23|105.45|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||105.45|100.23|
72552297|NCT00910663|144635302|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Geometric Test/Ref Ratio x 100|103.35||||||90.0|100.51|106.27|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||106.27|100.51|
72552298|NCT02865850|144635303|NON_INFERIORITY|Establishment of non-inferiority was based on a margin of -0.75 g/dL applied to the difference in mean change: Vadadustat minus Darbepoetin alfa.|Least squares mean difference|-0.31|STANDARD_ERROR_OF_MEAN|0.11|||TWO_SIDED|95.0|-0.53|-0.1||||||Treatment comparison: Vadadustat minus Darbepoetin Alfa||-0.10|-0.53|
72552299|NCT02865850|144635304|NON_INFERIORITY|The prespecified non-inferiority margin was 1.25 (per Food and Drug Administration \[FDA\]) and 1.30 (per European Medicines Agency \[EMA\]).|Hazard Ratio (HR)|0.97|||=|0.995|TWO_SIDED|95.0|0.536|1.761|||Log Rank|Based on non-parametric analysis.||Statistical analysis from study AKB-6548-CI-0016 has been reported in this section.||1.761|0.536|=0.9950
72585059|NCT03331796|144701501|SUPERIORITY||Mean Difference (Final Values)|-1.4|STANDARD_ERROR_OF_MEAN|2.0||0.48|TWO_SIDED|95.0|-5.5|2.6|||Regression, Linear|Adjusted for baseline||a priori threshold for statistical significance = .05||2.6|-5.5|0.48
72585060|NCT03331796|144701501|SUPERIORITY||Mean Difference (Final Values)|-2.7|STANDARD_ERROR_OF_MEAN|2.0||0.18|TWO_SIDED|95.0|-6.8|1.3|||Regression, Linear|Adjusted for baseline||a priori threshold for statistical significance = .05||1.3|-6.8|0.18
72585061|NCT03331796|144701502|SUPERIORITY||Median Difference (Final Values)|-2.7|STANDARD_ERROR_OF_MEAN|1.5||0.075|TWO_SIDED|95.0|-5.7|0.3|||Regression, Linear|Adjusted for baseline||a priori threshold for statistical significance = .05||0.3|-5.7|0.075
72585062|NCT03331796|144701502|SUPERIORITY||Mean Difference (Final Values)|-2.1|STANDARD_ERROR_OF_MEAN|1.6||0.195|TWO_SIDED|95.0|-5.4|1.1|||Regression, Linear|Adjusted for baseline||a priori threshold for statistical significance = .05||1.1|-5.4|0.195
72585063|NCT03331796|144701503|SUPERIORITY||Mean Difference (Final Values)|1.2|STANDARD_ERROR_OF_MEAN|1.1||0.28|TWO_SIDED|95.0|-1.0|3.4|||Regression, Linear|Adjusted for baseline||a priori threshold for statistical significance = .05||3.4|-1.0|0.28
72585064|NCT03331796|144701503|SUPERIORITY||Mean Difference (Final Values)|1.4|STANDARD_ERROR_OF_MEAN|1.1||0.21|TWO_SIDED|95.0|-0.8|3.6|||Regression, Linear|Adjusted for baseline||a priori threshold for statistical significance = .05||3.6|-0.8|0.21
72585065|NCT03331796|144701504|SUPERIORITY||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|1.3||0.66|TWO_SIDED|95.0|-3.2|2.1|||Regression, Linear|Adjusted for baseline||a priori threshold for statistical significance = .05||2.1|-3.2|0.66
72585066|NCT03331796|144701504|SUPERIORITY||Mean Difference (Final Values)|-2.2|STANDARD_ERROR_OF_MEAN|1.3||0.11|TWO_SIDED|95.0|-4.9|0.5|||Regression, Linear|||a priori threshold for statistical significance = .05||0.5|-4.9|0.11
72585067|NCT03331796|144701505|SUPERIORITY||Mean Difference (Final Values)|-0.06|STANDARD_ERROR_OF_MEAN|0.11||0.59|TWO_SIDED|95.0|-0.29|0.17|||Regression, Linear|Adjusted for baseline||a priori threshold for statistical significance = .05||0.17|-0.29|0.59
72585068|NCT03331796|144701505|SUPERIORITY||Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.11||0.64|TWO_SIDED|95.0|-0.17|0.28|||Regression, Linear|Adjusted for baseline||a priori threshold for statistical significance = .05||0.28|-0.17|0.64
72585069|NCT03331796|144701508|SUPERIORITY|||||||0.768||||||a priori threshold for statistical significance = .05|ANOVA|||||||0.768
72585070|NCT00720213|144701540|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.98|STANDARD_DEVIATION|8.03||0.0054|TWO_SIDED|95.0|1.44|6.51|||Wilcoxon Signed Rank test|||Each participant was treated with the BiPAP autoSV2 (ASV2) and autoSV Advanced (ASV3) on two separate nights; therefore, the data were analyzed as paired samples. Depending on normality, each endpoint was analyzed with either a paired t-test or the nonparametric Wilcoxon Signed Ranks test. All comparisons were 2-sided conducted at a 5% level of significance.||6.51|1.44|0.0054
72585071|NCT01420068|144701566|SUPERIORITY||Mean Difference (Net)|0.31||||0.84|TWO_SIDED|95.0|-2.74|3.37||p-value for statistical significance at 0.05 level for 2-sided superiority testing.|ANCOVA|Treatment regimen, region, age strata, and hypertension etiology (primary, secondary) as factors, and Baseline weight as covariates.||||3.37|-2.74|0.840
72585072|NCT01420068|144701567|SUPERIORITY||Mean Difference (Net)|0.69||||0.303|TWO_SIDED|95.0|-0.63|2.02||p-value for statistical significance at 0.05 level for 2-sided superiority testing.|ANCOVA|Treatment regimen, region, age strata, and hypertension etiology (primary, secondary) as factors, and Baseline height as covariates.||||2.02|-0.63|0.303
72552300|NCT02865850|144635304|NON_INFERIORITY|The prespecified non-inferiority margin was 1.25 (per FDA) and 1.30 (per EMA).|Hazard Ratio (HR)|0.96|||=|0.4877|TWO_SIDED|95.0|0.833|1.113|||Log Rank|Based on non-parametric analysis.||MACE analysis was performed on pooled data from studies AKB-6548-CI-0016 (NCT02865850) and AKB-6548-CI-0017 (NCT02892149). Time to first MACE for the Vadadustat and Darbepoetin alfa treatment groups was as follows: participants with events = 355 and 377 respectively; median time to first event (Q1, Q3) = 46.14 (24.71, 77.14) weeks versus 47.00 (22.43, 74.43) weeks, respectively. Statistical analysis from the pooled data has been reported in this section.||1.113|0.833|=0.4877
72552301|NCT02865850|144635305|NON_INFERIORITY|Establishment of non-inferiority was based on a margin of -0.75 g/dL applied to the difference in mean change: Vadadustat minus Darbepoetin alfa.|Least squares mean difference|-0.07|STANDARD_ERROR_OF_MEAN|0.134|||TWO_SIDED|95.0|-0.34|0.19||||||Treatment comparison: Vadadustat minus Darbepoetin Alfa||0.19|-0.34|
72552302|NCT02865850|144635306|NON_INFERIORITY|The prespecified non-inferiority margin was 1.25 (per FDA) and 1.30 (per EMA).|Hazard Ratio (HR)|1.04|||=|0.8871|TWO_SIDED|95.0|0.618|1.743|||Log Rank|Based on non-parametric analysis.||Statistical analysis from study AKB-6548-CI-0016 has been reported in this section.||1.743|0.618|=0.8871
72585073|NCT01420068|144701568|SUPERIORITY||Mean Difference (Net)|0.03||||0.957|TWO_SIDED|95.0|-1.06|1.12||p-value for statistical significance at 0.05 level for 2-sided superiority testing.|ANCOVA|Treatment regimen, region, age strata, and hypertension etiology (primary, secondary) as factors, and Baseline BMI as covariates.||||1.12|-1.06|0.957
72585074|NCT01420068|144701570|SUPERIORITY||Mean Difference (Net)|0.02||||0.992|TWO_SIDED|95.0|-3.29|3.33||p-value for statistical significance at 0.05 level for 2-sided superiority testing.|ANCOVA|Treatment regimen, region, age strata, and Baseline weight as covariates||Primary Hypertension group (at LT Visit 18 \[Week 104\])||3.33|-3.29|0.992
72585075|NCT01420068|144701570|SUPERIORITY||Mean Difference (Net)|-3.06||||0.215|TWO_SIDED|95.0|-8.22|2.1||p-value for statistical significance at 0.05 level for 2-sided superiority testing.|ANCOVA|Treatment regimen, region, age strata, and Baseline weight as covariates.||Secondary hypertension group (at LT Visit 19 \[Week 156\])||2.10|-8.22|0.215
72585076|NCT01420068|144701571|SUPERIORITY||Mean Difference (Net)|0.62||||0.403|TWO_SIDED|95.0|-0.85|2.09||p-value for statistical significance at 0.05 level for 2-sided superiority testing.|ANCOVA|Treatment regimen, region, age strata, and Baseline height as covariates||Primary Hypertension group (at LT Visit 18 \[Week 104\])||2.09|-0.85|0.403
72585077|NCT01420068|144701571|SUPERIORITY||Mean Difference (Net)|0.92||||0.67|TWO_SIDED|95.0|-3.74|5.57||p-value for statistical significance at 0.05 level for 2-sided superiority testing.|ANCOVA|Treatment regimen, region, age strata, and Baseline height as covariates.||Secondary hypertension group (at LT Visit 19 \[Week 156\])||5.57|-3.74|0.670
72585078|NCT01420068|144701572|SUPERIORITY||Mean Difference (Net)|-0.11||||0.86|TWO_SIDED|95.0|-1.29|1.08||p-value for statistical significance at 0.05 level for 2-sided superiority testing.|ANCOVA|Treatment regimen, region, age strata, and Baseline BMI as covariates||Primary Hypertension group (at LT Visit 18 \[Week 104\])||1.08|-1.29|0.860
72552303|NCT02865850|144635306|NON_INFERIORITY|The prespecified non-inferiority margin was 1.25 (per FDA) and 1.30 (per EMA).|Hazard Ratio (HR)|0.96|||=|0.4096|TWO_SIDED|95.0|0.84|1.096|||Log Rank|Based on non-parametric analysis.||MACE analysis was performed on pooled data from studies AKB-6548-CI-0016 (NCT02865850) and AKB-6548-CI-0017 (NCT02892149). Time to first MACE plus hospitalization for heart failure or thromboembolic event Excluding vascular access thrombosis for the Vadadustat and Darbepoetin alfa treatment groups was as follows: participants with events = 420 and 449 respectively; median time to first event (Q1, Q3) = 42.07 (21.50, 71.14) weeks versus 45.29 (22.29, 72.43) weeks, respectively.||1.096|0.840|=0.4096
72552304|NCT02865850|144635307|NON_INFERIORITY|The prespecified non-inferiority margin was 1.25 (per FDA) and 1.30 (per EMA).|Hazard Ratio (HR)|1.36|||=|0.521|TWO_SIDED|95.0|0.67|2.771|||Gray's test|Based on non-parametric analysis.||Statistical analysis from study AKB-6548-CI-0016 has been reported in this section.||2.771|0.670|=0.5210
72585079|NCT01420068|144701572|SUPERIORITY||Mean Difference (Net)|-1.17||||0.32|TWO_SIDED|95.0|-3.66|1.32||p-value for statistical significance at 0.05 level for 2-sided superiority testing.|ANCOVA|Treatment regimen, region, age strata, and Baseline BMI as covariates.||Secondary hypertension group (at LT Visit 19 \[Week 156\])||1.32|-3.66|0.320
72585080|NCT00758290|144701574|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANOVA|||||||0.05
72585081|NCT00884117|144701585|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Kruskal-Wallis|||||||<0.0001
72585082|NCT00884117|144701585|SUPERIORITY_OR_OTHER||||||<|0.01|||||||Pairwise Wilcoxon|||||||<0.01
72585083|NCT00884117|144701585|SUPERIORITY_OR_OTHER||||||<|0.01|||||||Pairwise Wilcoxon|||||||<0.01
72585084|NCT00884117|144701586|SUPERIORITY_OR_OTHER|||||||0.015|||||||Kruskal-Wallis|||||||0.015
72585085|NCT00884117|144701586|SUPERIORITY_OR_OTHER|||||||0.009|||||||Pairwise Wilcoxon|||||||0.009
72585086|NCT00884117|144701586|SUPERIORITY_OR_OTHER|||||||0.03|||||||Pairwise Wilcoxon|||||||0.03
72585087|NCT00884117|144701587|SUPERIORITY_OR_OTHER|||||||0.0005|||||||Kruskal-Wallis|||||||0.0005
72585088|NCT00884117|144701587|SUPERIORITY_OR_OTHER|||||||0.008|||||||Pairwise Wilcoxon|||||||0.008
72585089|NCT00884117|144701587|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Pairwise Wilcoxon|||||||<0.0001
72585090|NCT00884117|144701588|SUPERIORITY_OR_OTHER|||||||0.0002|||||||Kruskal-Wallis|||||||0.0002
72585091|NCT00884117|144701588|SUPERIORITY_OR_OTHER|||||||0.008|||||||Pairwise Wilcoxon|||||||0.008
72585092|NCT00884117|144701588|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Pairwise Wilcoxon|||||||<0.0001
72585093|NCT00884117|144701591|SUPERIORITY_OR_OTHER|||||||0.4464|||||||Cochran-Mantel-Haenszel|||Resistant versus Susceptible||||0.4464
72585094|NCT00884117|144701592|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||Resistant versus Susceptible||||<0.0001
72585095|NCT00884117|144701593|SUPERIORITY_OR_OTHER|||||||0.2499|||||||Cochran-Mantel-Haenszel|||Resistant versus Susceptible||||0.2499
72585096|NCT04830969|144701600|SUPERIORITY|||||||0.16|||||||t-test, 2 sided|used generalized linear models adjusted for baseline CRP||||||0.16
72585097|NCT04830969|144701601|SUPERIORITY|||||||0.08|||||||t-test, 2 sided|used generalized linear models adjusted for baseline CRP||||||0.08
72585098|NCT04830969|144701602|SUPERIORITY|||||||0.14|||||||t-test, 2 sided|used generalized linear models adjusted for baseline CRP||Baseline to 3 months||||0.14
72585099|NCT04830969|144701602|SUPERIORITY|||||||0.8|||||||t-test, 2 sided|used generalized linear models adjusted for baseline CRP||Baseline to 6 months||||0.8
72585100|NCT04830969|144701603|SUPERIORITY||||||<|0.01|||||||t-test, 2 sided|used generalized linear models adjusted for baseline CRP||Baseline to 3 months||||<0.01
72585101|NCT04830969|144701603|SUPERIORITY|||||||0.09|||||||t-test, 2 sided|used generalized linear models adjusted for baseline CRP||||||0.09
72585102|NCT04830969|144701604|SUPERIORITY||||||<|0.01|||||||t-test, 2 sided|used generalized linear models adjusted for baseline CRP||Baseline to 3 months||||< 0.01
72585103|NCT04830969|144701604|SUPERIORITY|||||||0.03|||||||t-test, 2 sided|used generalized linear models adjusted for baseline CRP||Baseline to 6 months||||0.03
72585104|NCT04830969|144701605|SUPERIORITY||||||<|0.01|||||||t-test, 2 sided|used generalized linear models adjusted for baseline CRP||Baseline to 3 months||||< 0.01
72585105|NCT04830969|144701605|SUPERIORITY|||||||0.09|||||||t-test, 2 sided|used generalized linear models adjusted for baseline CRP||Baseline to 6 months||||0.09
72585106|NCT04830969|144701606|SUPERIORITY|||||||0.01|||||||t-test, 2 sided|||Baseline to 3 months||||0.01
72585107|NCT04830969|144701606|SUPERIORITY|||||||0.86|||||||t-test, 2 sided|used generalized linear models adjusted for baseline CRP||Baseline to 3 months||||0.86
72585108|NCT04830969|144701606|SUPERIORITY|||||||0.047|||||||t-test, 2 sided|||Baseline to 6 months||||0.047
72585109|NCT04830969|144701606|SUPERIORITY|||||||0.75|||||||t-test, 2 sided|used generalized linear models adjusted for baseline CRP||Baseline to 6 months||||0.75
72585110|NCT04830969|144701607|SUPERIORITY|||||||0.44|||||||t-test, 2 sided|||Baseline to 3 months||||0.44
72585111|NCT04830969|144701607|SUPERIORITY|||||||0.22|||||||t-test, 2 sided|used generalized linear models adjusted for baseline CRP||Baseline to 3 months||||0.22
72585112|NCT04830969|144701607|SUPERIORITY|||||||0.29|||||||t-test, 2 sided|||Baseline to 6 months||||0.29
72413604|NCT02896855|144336271|OTHER||Difference in Objective Response|9.98||||0.1108|TWO_SIDED|95.0|-2.65|22.6|||Fisher Exact|Unadjusted|The difference in objective response is calculated as Arm B: Pertuzumab minus Arm A: Placebo. 95% CI was calculated using Hauck-Anderson method.|Hypothesis testing is considered exploratory in this bridging study.||22.60|-2.65|0.1108
72585113|NCT04830969|144701607|SUPERIORITY|||||||0.15|||||||t-test, 2 sided|used generalized linear models adjusted for baseline CRP||Baseline to 6 months||||0.15
72585114|NCT04830969|144701608|SUPERIORITY||||||<|0.01|||||||t-test, 2 sided|||Baseline to 3 months||||<0.01
72585115|NCT04830969|144701608|SUPERIORITY|||||||0.31|||||||t-test, 2 sided|used generalized linear models adjusted for baseline CRP||Baseline to 3 months||||0.31
72585116|NCT04830969|144701608|SUPERIORITY|||||||0.08|||||||t-test, 2 sided|||Baseline to 6 months||||0.08
72585117|NCT04830969|144701608|SUPERIORITY|||||||0.54|||||||t-test, 2 sided|used generalized linear models adjusted for baseline CRP||Baseline to 6 months||||0.54
72585118|NCT04830969|144701609|SUPERIORITY|||||||0.01|||||||t-test, 2 sided|||Baseline to 3 months||||0.01
72585119|NCT04830969|144701609|SUPERIORITY|||||||0.04|||||||t-test, 2 sided|used generalized linear models adjusted for baseline CRP||Baseline to 3 months||||0.04
72585120|NCT04830969|144701609|SUPERIORITY|||||||0.03|||||||t-test, 2 sided|||Baseline to 6 months||||0.03
72585121|NCT04830969|144701609|SUPERIORITY|||||||0.38|||||||t-test, 2 sided|used generalized linear models adjusted for baseline CRP||Baseline to 6 months||||0.38
72585122|NCT04830969|144701610|SUPERIORITY|||||||0.02|||||||t-test, 2 sided|||Baseline to 3 months||||0.02
72585123|NCT04830969|144701610|SUPERIORITY|||||||0.18|||||||t-test, 2 sided|used generalized linear models adjusted for baseline CRP||Baseline to 3 months||||0.18
72585124|NCT04830969|144701610|SUPERIORITY|||||||0.08|||||||t-test, 2 sided|||Baseline to 6 months||||0.08
72585125|NCT04830969|144701610|SUPERIORITY|||||||0.41|||||||t-test, 2 sided|used generalized linear models adjusted for baseline CRP||Baseline to 6 months||||0.41
72585126|NCT04830969|144701611|SUPERIORITY|||||||0.27|||||||t-test, 2 sided|used generalized linear models adjusted for baseline CRP||||||0.27
72585127|NCT04830969|144701612|SUPERIORITY|||||||0.54|||||||t-test, 2 sided|used generalized linear models adjusted for baseline CRP||||||0.54
72585128|NCT04830969|144701613|SUPERIORITY|||||||0.12|||||||t-test, 2 sided|used generalized linear models adjusted for baseline CRP||||||0.12
72585129|NCT04830969|144701614|SUPERIORITY|||||||0.2|||||||t-test, 2 sided|||||||0.20
72585130|NCT04830969|144701614|SUPERIORITY|||||||0.07|||||||t-test, 2 sided|used generalized linear models adjusted for baseline CRP||||||0.07
72585131|NCT04830969|144701615|SUPERIORITY|||||||0.58|||||||t-test, 2 sided|||||||0.58
72585132|NCT04830969|144701615|SUPERIORITY|||||||0.64|||||||t-test, 2 sided|used generalized linear models adjusted for baseline CRP||||||0.64
72585133|NCT04830969|144701616|SUPERIORITY|||||||0.46|||||||t-test, 2 sided|||||||0.46
72585134|NCT04830969|144701616|SUPERIORITY|||||||0.11|||||||t-test, 2 sided|used generalized linear models adjusted for baseline CRP||||||0.11
72585135|NCT04830969|144701617|SUPERIORITY|||||||0.7|||||||t-test, 2 sided|||at baseline||||0.7
72585136|NCT04830969|144701617|SUPERIORITY|||||||0.29|||||||t-test, 2 sided|||6 months||||0.29
72585137|NCT04830969|144701618|SUPERIORITY|||||||0.53|||||||t-test, 2 sided|||||||0.53
72585138|NCT01786993|144701630|SUPERIORITY_OR_OTHER||Event-Free Probability|0.932|||||TWO_SIDED|95.0|0.904|0.951||||||"The hypothesis is formally expressed as:~H0: Freedom from system-related complications through 9 months ≤ 75% Ha: Freedom from system-related complications through 9 months \> 75%"||0.951|0.904|
72585139|NCT01786993|144701631|NON_INFERIORITY_OR_EQUIVALENCE|Assuming a binomial distribution with a 44% probability for non-responders between 3 months and 9 months in both study arms, the sample size required for 85% power to reject the null hypothesis at the 5% significance level is 394. To adjust for a potential net crossover of 15% and an overall attrition rate of 20%, the total number of patients required to be enrolled in this study is 506.|Difference of proportions|-0.049||||0.0131|ONE_SIDED|97.5|-0.138||||normal approximation for binomial dist|||"H0: (Non-responder rate in the BiV arm between 3 M randomization and 9 M) - (Non-responder rate in the MPP arm between 3 M randomization and 9 M) ≤ -0.15~Ha: (Non-responder rate in the BiV arm between 3 M randomization and 9 M) - (Non-responder rate in the MPP arm between 3 M randomization and 9 M) \> -0.15~The null hypothesis will be rejected at the 2.5% significance level if the lower one-sided 97.5% confidence bound for the difference in the proportions is above -0.15."|||-0.138|0.0131
72585140|NCT02712554|144701635|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||||||<0.0001
72585141|NCT02712554|144701635|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||||||<0.0001
72585142|NCT02712554|144701635|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2344|||||||ANOVA|||||||0.2344
72585143|NCT02712554|144701635|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4737|||||||ANOVA|||||||0.4737
72585144|NCT02712554|144701635|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||||||<0.0001
72585145|NCT02712554|144701635|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||||||<0.0001
72585146|NCT02712554|144701639|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||Emax: Treatment C (low-dose M366) - Placebo||||<.0001
72413605|NCT02896855|144336272|OTHER||Cox Proportional Hazard|0.78||||0.2867|TWO_SIDED|95.0|0.49|1.24|||Log Rank|Two-sided log-rank test was used, stratified by disease type and hormone-receptor status.|This stratified Hazard Ratio (HR) is calculated as Arm B: Pertuzumab versus Arm A: Placebo. Cox proportional hazards model, stratified by disease type and hormone-receptor status, was used to estimate HR and its 95% CI.|Hypothesis testing is considered exploratory in this bridging study.||1.24|0.49|0.2867
72413606|NCT02896855|144336279|OTHER||Mean Difference (Net)|-0.6|||||TWO_SIDED|95.0|-1.96|0.75|||||The treatment difference for change from baseline to maximum on-treatment decrease in LVEF is defined as Arm B: Pertuzumab minus Arm A: Placebo.|||0.75|-1.96|
72413607|NCT02585895|144336292|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|74.2|||<|0.0001|TWO_SIDED|95.0|44.6|86.8|||Cochran-Mantel-Haenszel|Based on Cochran-Mantel-Haenszel (CMH) test stratified by screening LDL-C level|Treatment difference used apheresis as the reference.|||86.8|44.6|< 0.0001
72413608|NCT02585895|144336293|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|-52.74|STANDARD_ERROR_OF_MEAN|5.64|<|0.0001|TWO_SIDED|95.0|-64.18|-41.3|||Repeated measures linear effects model|Model included treatment group, screening LDL-C level, scheduled visit, and the interaction of treatment group with scheduled visit as covariates.|Treatment difference used apheresis as the reference.|||-41.30|-64.18|< 0.0001
72413609|NCT02585895|144336294|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|-46.37|STANDARD_ERROR_OF_MEAN|4.67|<|0.0001|TWO_SIDED|95.0|-55.85|-36.9|||Repeated measures linear effects model|Model included treatment group, screening LDL-C level, scheduled visit, and the interaction of treatment group with scheduled visit as covariates.|Treatment difference used apheresis as the reference.|||-36.90|-55.85|< 0.0001
72585147|NCT02712554|144701639|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||Emax: Treatment D (high-dose M366) - Placebo||||<.0001
72585148|NCT02712554|144701639|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1267|||||||ANOVA|||Emax: Treatment A (low-dose CL-108) - Treatment C (low-dose M366)||||0.1267
72585149|NCT02712554|144701639|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1767|||||||ANOVA|||Emax: Treatment B (high-dose CL-108) - Treatment D (high-dose M366)||||0.1767
72413610|NCT02585895|144336295|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|-35.8|STANDARD_ERROR_OF_MEAN|3.74|<|0.0001|TWO_SIDED|95.0|-43.39|-28.21|||Repeated measures linear effects model|Model included treatment group, screening LDL-C level, scheduled visit, and the interaction of treatment group with scheduled visit as covariates.||||-28.21|-43.39|< 0.0001
72413611|NCT01380327|144336308|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.7||||0.001|TWO_SIDED|95.0|1.2|2.3|||Mixed Models Analysis||Estimated value \& associated CI is the ratio of change (baseline to post-baseline) in placebo group (denominator=1.18) vs. high dose group (numerator=1.98).|Analysis compared cockroach SLIT -high dose, Placebo - high dose||2.3|1.2|0.001
72585150|NCT02712554|144701639|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||Emax: Treatment A (low-dose CL-108) - Placebo||||<.0001
72413612|NCT01380327|144336308|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|2.3|||<|0.0001|TWO_SIDED|95.0|1.7|3.1|||Mixed Models Analysis||Estimated value \& associated CI is the ratio of change (baseline to post-baseline) in placebo group (denominator=1.18) vs. low dose group (numerator=2.69).|Analysis compared cockroach SLIT - low dose, placebo - low dose||3.1|1.7|<0.0001
72413613|NCT01380327|144336309|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.3|||<|0.0001|TWO_SIDED|95.0|1.1|1.4|||Mixed Models Analysis||Estimated value \& associated CI is the ratio of change (baseline to post-baseline) in placebo group (denominator=1.04) vs. high dose group (numerator=1.32).|Analysis compared cockroach SLIT - high dose, placebo - high dose||1.4|1.1|<0.0001
72413614|NCT01380327|144336309|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.1||||0.11|TWO_SIDED|95.0|1.0|1.2|||Mixed Models Analysis||Estimated value \& associated CI is the ratio of change (baseline to post-baseline) in placebo group (denominator=1.04) vs. low dose group (numerator=1.14).|Analysis compared cockroach SLIT - low dose, placebo - low dose||1.2|1.0|0.11
72413615|NCT01380327|144336310|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.5||||0.06|TWO_SIDED|95.0|1.0|2.4|||Mixed Models Analysis||Estimated value and associated CI is the ratio of change (baseline to post-baseline) in placebo group (denominator=1.03) vs. high dose group (numerator=1.57).|Analysis compared cockroach SLIT - high dose, placebo - high dose||2.4|1.0|0.06
72585151|NCT02712554|144701639|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||Emax: Treatment B (high-dose CL-108) - Placebo||||<.0001
72585152|NCT02712554|144701639|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0119|||||||ANOVA|||Emin: Treatment C (low-dose M366) - Placebo||||0.0119
72585153|NCT02712554|144701639|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0025|||||||ANOVA|||Emin: Treatment D (high-dose M366) - Placebo||||0.0025
72585154|NCT02712554|144701639|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1679|||||||ANOVA|||Emin: Treatment A (low-dose CL-108) - Treatment C (low-dose M366)||||0.1679
72585155|NCT02712554|144701639|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0318|||||||ANOVA|||Emin: Treatment B (high-dose CL-108) - Treatment D (high-dose M366)||||0.0318
72585156|NCT02712554|144701639|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0002|||||||ANOVA|||Emin: Treatment A (low-dose CL-108) - Placebo||||0.0002
72585157|NCT02712554|144701639|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||||||<.0001
72585158|NCT02712554|144701640|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||Emax: Treatment C (low-dose M366) - Placebo||||<.0001
72585159|NCT02712554|144701640|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||Emax: Treatment D (high-dose M366) - Placebo||||<.0001
72413616|NCT01380327|144336310|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.4||||0.13|TWO_SIDED|95.0|0.9|2.2|||Mixed Models Analysis||Estimated value \& associated CI is the ratio of change (baseline to post-baseline) in placebo group (denominator=1.03) vs. low dose group (numerator=1.45).|Analysis compared cockroach SLIT - low dose, placebo - low dose||2.2|0.9|0.13
72413617|NCT01380327|144336311|SUPERIORITY_OR_OTHER||Treatment effect|-12.9||||0.21|TWO_SIDED|95.0|-33.2|7.5|||Mixed Models Analysis||Estimated value\& associated CI is the treatment effect: baseline to post-baseline change in measurement in high dose group (-7.2) minus baseline to post-baseline change in measurement in placebo group (5.7) .|Analysis compared cockroach SLIT - high dose, placebo - high dose||7.5|-33.2|0.21
72413618|NCT01380327|144336311|SUPERIORITY_OR_OTHER||Treatment effect|13.5||||0.2|TWO_SIDED|95.0|-7.1|34.1|||Mixed Models Analysis||Estimated value\& associated CI is the treatment effect: baseline to post-baseline change in measurement in high dose group (19.2) minus baseline to post-baseline change in measurement in placebo group (5.7) .|Analysis compared cockroach SLIT - low dose, placebo - low dose||34.1|-7.1|0.20
72413619|NCT02219932|144336364|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.61||||0.006|TWO_SIDED|95.0|1.15|2.26|||Regression, Logistic||fampridine vs. placebo|Based on logistic regression, adjusting for baseline MSWS-12 score, baseline TUG speed, age, screening Expanded Disability Status Scale (EDSS) score and prior aminopyridine. Missing data handled by multiple imputation. Hypothesis testing was performed at the 2-sided 5% significance level overall, with adjustment for testing multiple secondary endpoints.||2.26|1.15|0.006
72413620|NCT02219932|144336364|SUPERIORITY_OR_OTHER||Risk Difference for Adjusted Proportions|0.104|||||TWO_SIDED|95.0|0.03|0.178||||||Based on logistic regression, adjusting for baseline MSWS-12 score, baseline TUG speed, age, screening Expanded Disability Status Scale (EDSS) score and prior aminopyridine. Missing data handled by multiple imputation. Hypothesis testing was performed at the 2-sided 5% significance level overall, with adjustment for testing multiple secondary endpoints.||0.178|0.030|
72413621|NCT02219932|144336364|SUPERIORITY_OR_OTHER||Relative Risk|1.38|||||TWO_SIDED|95.0|1.06|1.7||||||Based on logistic regression, adjusting for baseline MSWS-12 score, baseline TUG speed, age, screening Expanded Disability Status Scale (EDSS) score and prior aminopyridine. Missing data handled by multiple imputation. Hypothesis testing was performed at the 2-sided 5% significance level overall, with adjustment for testing multiple secondary endpoints.||1.70|1.06|
72413622|NCT02219932|144336365|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.46||||0.03|TWO_SIDED|95.0|1.04|2.07|||Regression, Logistic|||Based on logistic regression, adjusting for baseline TUG speed, screening EDSS score and prior aminopyridine. Missing data were handled using multiple imputation.||2.07|1.04|0.030
72413623|NCT02219932|144336365|SUPERIORITY_OR_OTHER||Risk Difference for Adjusted Proportions|0.092|||||TWO_SIDED|95.0|0.009|0.175||||||Based on logistic regression, adjusting for baseline TUG speed, screening EDSS score and prior aminopyridine. Missing data were handled using multiple imputation.||0.175|0.009|
72413624|NCT02219932|144336365|SUPERIORITY_OR_OTHER||Relative Risk|1.25|||||TWO_SIDED|95.0|0.99|1.51||||||Based on logistic regression, adjusting for baseline TUG speed, screening EDSS score and prior aminopyridine. Missing data were handled using multiple imputation.||1.51|0.99|
72413625|NCT02219932|144336366|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.31|STANDARD_ERROR_OF_MEAN|0.925|<|0.001|TWO_SIDED|95.0|-5.13|-1.5|||mixed model for repeated measures|||||-1.50|-5.13|< 0.001
72413626|NCT02219932|144336367|SUPERIORITY_OR_OTHER||LS Mean Difference|0.41|STANDARD_ERROR_OF_MEAN|0.277||0.141|TWO_SIDED|95.0|-0.13|0.95|||mixed model for repeated measures|||||0.95|-0.13|0.141
72413627|NCT02219932|144336368|SUPERIORITY_OR_OTHER||LS Mean Difference|0.74|STANDARD_ERROR_OF_MEAN|0.573||0.197|TWO_SIDED|95.0|-0.38|1.86|||mixed model for repeated measures|||||1.86|-0.38|0.197
72413628|NCT01866410|144336375|OTHER|||||||0.4|||||||Log Rank|||||||0.4
72413629|NCT01866410|144336376|OTHER|||||||0.5|||||||Log Rank|||||||0.5
72413630|NCT00968669|144336401|SUPERIORITY_OR_OTHER|||||||0.435|||||||ANOVA|Missing mean ACQ scores at Day 92 was imputed by last observation carried forward||||||0.435
72413631|NCT00968669|144336401|SUPERIORITY_OR_OTHER|||||||0.828|||||||ANOVA|Missing mean ACQ scores at Day 92 was imputed by last observation carried forward||||||0.828
72585160|NCT02712554|144701640|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0858|||||||ANOVA|||Emax: Treatment A (low-dose CL-108) - Treatment C (low-dose M366)||||0.0858
72585161|NCT02712554|144701640|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2877|||||||ANOVA|||Emax: Treatment B (high-dose CL-108) - Treatment D (high-dose M366)||||0.2877
72585162|NCT02712554|144701640|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||Emax: Treatment A (low-dose CL-108) - Placebo||||<.0001
72585163|NCT02712554|144701640|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||Emax: Treatment B (high-dose CL-108) - Placebo||||<.0001
72585164|NCT02712554|144701640|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0009|||||||ANOVA|||Emin: Treatment C (low-dose M366) - Placebo||||0.0009
72585165|NCT02712554|144701640|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0001|||||||ANOVA|||Emin: Treatment D (high-dose M366) - Placebo||||0.0001
72585166|NCT02712554|144701640|SUPERIORITY_OR_OTHER_LEGACY|||||||0.113|||||||ANOVA|||Emin: Treatment A (low-dose CL-108) - Treatment C (low-dose M366)||||0.1130
72585167|NCT02712554|144701640|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0575|||||||ANOVA|||Emin: Treatment B (high-dose CL-108) - Treatment D (high-dose M366)||||0.0575
72585168|NCT02712554|144701640|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||Emin: Treatment A (low-dose CL-108) - Placebo||||<.0001
72585169|NCT02712554|144701640|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||Emin: Treatment B (high-dose CL-108) - Placebo||||<.0001
72585170|NCT02712554|144701641|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||Emax: Treatment C (low-dose M366) - Placebo||||<.0001
72585171|NCT02712554|144701641|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||Emax: Treatment D (high-dose M366) - Placebo||||<.0001
72585172|NCT02712554|144701641|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4025|||||||ANOVA|||Emax: Treatment A (low-dose CL-108) - Treatment C (low-dose M366)||||0.4025
72585173|NCT02712554|144701641|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3184|||||||ANOVA|||Emax: Treatment B (high-dose CL-108) - Treatment D (high-dose M366)||||0.3184
72585174|NCT02712554|144701641|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||Emax: Treatment A (low-dose CL-108) - Placebo||||<.0001
72585175|NCT02712554|144701641|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||Emax: Treatment B (high-dose CL-108) - Placebo||||<.0001
72585176|NCT02712554|144701642|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||TA\_AUE0-8hr: Treatment C (low-dose M366) - Placebo||||<.0001
72585177|NCT02712554|144701642|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||TA\_AUE0-8hr: Treatment D (high-dose M366) - Placebo||||<.0001
72585178|NCT02712554|144701642|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2628|||||||ANOVA|||TA\_AUE0-8hr: Treatment A (low-dose CL-108) - Treatment C (low-dose M366)||||0.2628
72585179|NCT02712554|144701642|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2262|||||||ANOVA|||TA\_AUE0-8hr: Treatment B (high-dose CL-108) - Treatment D (high-dose M366)||||0.2262
72585180|NCT02712554|144701642|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||TA\_AUE0-8hr: Treatment A (low-dose CL-108) - Placebo||||<.0001
72585181|NCT02712554|144701642|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||TA\_AUE0-8hr: Treatment B (high-dose CL-108) - Placebo||||<.0001
72585182|NCT02712554|144701643|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||Emax: Treatment C (low-dose M366) - Placebo||||<.0001
72585183|NCT02712554|144701643|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||Emax: Treatment D (high-dose M366) - Placebo||||<.0001
72585184|NCT02712554|144701643|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1839|||||||ANOVA|||Emax: Treatment A (low-dose CL-108) - Treatment C (low-dose M366)||||0.1839
72585185|NCT02712554|144701643|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1751|||||||ANOVA|||Emax: Treatment B (high-dose CL-108) - Treatment D (high-dose M366)||||0.1751
72585186|NCT02712554|144701643|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||Emax: Treatment A (low-dose CL-108) - Placebo||||<.0001
72585187|NCT02712554|144701643|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||Emax: Treatment B (high-dose CL-108) - Placebo||||<.0001
72585188|NCT02712554|144701644|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||TA\_AUE0-8hr: Treatment C (low-dose M366) - Placebo||||<.0001
72585189|NCT02712554|144701644|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||TA\_AUE0-8hr: Treatment D (high-dose M366) - Placebo||||<.0001
72585190|NCT02712554|144701644|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4013|||||||ANOVA|||TA\_AUE0-8hr: Treatment A (low-dose CL-108) - Treatment C (low-dose M366)||||0.4013
72585191|NCT02712554|144701644|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0736|||||||ANOVA|||TA\_AUE0-8hr: Treatment B (high-dose CL-108) - Treatment D (high-dose M366)||||0.0736
72585192|NCT02712554|144701644|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||TA\_AUE0-8hr: Treatment A (low-dose CL-108) - Placebo||||<.0001
72585193|NCT02712554|144701644|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||TA\_AUE0-8hr: Treatment B (high-dose CL-108) - Placebo||||<.0001
72585194|NCT02712554|144701645|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||ANOVA|||Emax: Treatment C (low-dose M366) - Placebo||||<0.001
72585195|NCT02712554|144701645|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||ANOVA|||Emax: Treatment D (high-dose M366) - Placebo||||<0.001
72585196|NCT02712554|144701645|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2223|||||||ANOVA|||Emax: Treatment A (low-dose CL-108) - Treatment C (low-dose M366)||||0.2223
72413632|NCT00968669|144336401|SUPERIORITY_OR_OTHER|||||||0.628|||||||ANOVA|Missing mean ACQ scores at Day 92 was imputed by last observation carried forward||||||0.628
72413633|NCT00968669|144336402|SUPERIORITY_OR_OTHER|||||||0.271|||||||Pairwise Poisson Regression|||||||0.271
72552305|NCT02865850|144635307|NON_INFERIORITY|The prespecified non-inferiority margin was 1.25 (per FDA) and 1.30 (per EMA).|Hazard Ratio (HR)|0.95|||=|0.5007|TWO_SIDED|95.0|0.795|1.144|||Gray's test|Based on non-parametric analysis.||MACE analysis was performed on pooled data from studies AKB-6548-CI-0016 (NCT02865850) and AKB-6548-CI-0017 (NCT02892149). Time to first cardiovascular MACE for the Vadadustat and Darbepoetin alfa treatment groups was as follows: participants with events = 225 and 242 respectively; median time to first event (Q1, Q3) = 43.29 (21.71, 77.14) weeks versus 45.79 (21.14, 73.86) weeks, respectively. Statistical analysis from the pooled data has been reported in this section.||1.144|0.795|=0.5007
72552306|NCT02865850|144635308|NON_INFERIORITY|The prespecified non-inferiority margin was 1.25 (per FDA) and 1.30 (per EMA).|Hazard Ratio (HR)|1.1|||=|0.9527|TWO_SIDED|95.0|0.452|2.666|||Gray's test|Based on non-parametric analysis.||Statistical analysis from study AKB-6548-CI-0016 has been reported in this section.||2.666|0.452|=0.9527
72552307|NCT02865850|144635308|NON_INFERIORITY|The prespecified non-inferiority margin was 1.25 (per FDA) and 1.30 (per EMA).|Hazard Ratio (HR)|0.96|||=|0.6284|TWO_SIDED|95.0|0.766|1.195|||Gray's test|Based on non-parametric analysis.||MACE analysis was performed on pooled data from studies AKB-6548-CI-0016 (NCT02865850) and AKB-6548-CI-0017 (NCT02892149). Time to first cardiovascular death for the Vadadustat and Darbepoetin alfa treatment groups was as follows: participants with events = 150 and 160 respectively; median time to first event (Q1, Q3) = 43.71 (27.43, 77.14) weeks versus 49.29 (24.43, 74.07) weeks, respectively. Statistical analysis from the pooled data has been reported in this section.||1.195|0.766|=0.6284
72552308|NCT02865850|144635309|NON_INFERIORITY|The prespecified non-inferiority margin was 1.25 (per FDA) and 1.30 (per EMA).|Hazard Ratio (HR)|0.78|||=|0.5115|TWO_SIDED|95.0|0.388|1.555|||Log Rank|Based on non-parametric analysis.||Statistical analysis from study AKB-6548-CI-0016 has been reported in this section.||1.555|0.388|=0.5115
72552309|NCT02865850|144635309|NON_INFERIORITY|The prespecified non-inferiority margin was 1.25 (per FDA) and 1.30 (per EMA).|Hazard Ratio (HR)|0.95|||=|0.4878|TWO_SIDED|95.0|0.812|1.118|||Log Rank|Based on non-parametric analysis.||MACE analysis was performed on pooled data from studies AKB-6548-CI-0016 (NCT02865850) and AKB-6548-CI-0017 (NCT02892149). Time to first all-cause mortality for the Vadadustat and Darbepoetin alfa treatment groups was as follows: participants with events = 291 and 310 respectively; median time to first event (Q1, Q3) = 50.00 (29.71, 79.00) weeks versus 49.57 (25.86, 77.29) weeks, respectively. Statistical analysis from the pooled data has been reported in this section.||1.118|0.812|=0.4878
72552310|NCT02726581|144635320|SUPERIORITY||Hazard Ratio (HR)|0.9|||||TWO_SIDED|95.0|0.62|1.3||||||||1.30|0.62|
72552311|NCT02726581|144635321|SUPERIORITY||Hazard Ratio (HR)|0.79|||||TWO_SIDED|95.0|0.53|1.19||||||||1.19|0.53|
72552312|NCT02726581|144635322|SUPERIORITY||Odds Ratio (OR)|0.76|||||TWO_SIDED|95.0|0.39|1.46||||||||1.46|0.39|
72552313|NCT00552669|144635325|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||We used One way annalysis of a variance for means and standard deviation.||||<0.05
72552314|NCT00552669|144635326|SUPERIORITY_OR_OTHER|||||||0.05|||||||Chi-squared|||Based on our previous data the incidence of relevant clinical events was similar in both groups (ERACI III and ORAR II)||||0.05
72413634|NCT00968669|144336402|SUPERIORITY_OR_OTHER|||||||0.319|||||||Pairwise Poisson Regression|||||||0.319
72413635|NCT00968669|144336402|SUPERIORITY_OR_OTHER|||||||0.502|||||||Pairwise Poisson Regression|||||||0.502
72413636|NCT00968669|144336403|SUPERIORITY_OR_OTHER|||||||0.756|||||||Pairwise Poisson Regression|||||||0.756
72413637|NCT00968669|144336403|SUPERIORITY_OR_OTHER|||||||0.047|||||||Pairwise Poisson Regression|||||||0.047
72413638|NCT00968669|144336403|SUPERIORITY_OR_OTHER|||||||1|||||||Pairwise Poisson Regression|||||||1.000
72413639|NCT00968669|144336404|SUPERIORITY_OR_OTHER|||||||0.1764|||||||Fisher Exact|||||||0.1764
72413640|NCT00968669|144336404|SUPERIORITY_OR_OTHER|||||||0.4031|||||||Fisher Exact|||||||0.4031
72413641|NCT00968669|144336404|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||||||1.0000
72552315|NCT00552669|144635327|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Chi-squared|||"power calculation 80% Hypothesis: No significant diferences between Target Vessel Revascularization (TVR) between both groups.~All events will be recorded and an independent blind for groups clinical events committee will adjudicate each one."||||<0.05
72552316|NCT01844375|144635329|EQUIVALENCE|equivalence analysis||||||0.75|||||||Kruskal-Wallis|||||||0.75
72552317|NCT03020615|144635361|SUPERIORITY|||||||0.033|||||||t-test, 2 sided|||||||0.033
72552318|NCT03020615|144635364|SUPERIORITY|||||||0.0005|||||||Exact Wilcoxon (Mann-Whitley), two-sided|||||||0.0005
72552319|NCT03020615|144635366|SUPERIORITY|||||||0.011|||||||Exact Wilcoxon (Mann-Whitney), two-sided|||||||0.011
72552320|NCT03020615|144635367|SUPERIORITY|||||||0.03|||||||t-test, 2 sided|||||||0.030
72552321|NCT03020615|144635370|SUPERIORITY|||||||0.0009|||||||Exact Wilcoxon (Mann-Whitney), two-sided|||||||0.0009
72552322|NCT03020615|144635372|SUPERIORITY|||||||0.0004|||||||Exact Wilcoxon (Mann-Whitney), two-sided|||||||0.0004
72552323|NCT03020615|144635374|SUPERIORITY|||||||0.75|||||||Exact Wilcoxon (Mann-Whitney), two-sided|||||||0.75
72552324|NCT03020615|144635376|SUPERIORITY|||||||0.0013|||||||Exact Wilcoxon (Mann-Whitney), two-sided|||||||0.0013
72552325|NCT03020615|144635377|SUPERIORITY|||||||0.013|||||||t-test, 2 sided|||||||0.013
72552326|NCT00252720|144635394|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.024||||0.8487|TWO_SIDED|95.0|0.8|1.312|||Log Rank|Generalized||||1.312|0.800|0.8487
72552327|NCT02514122|144635428|SUPERIORITY||Mean Difference (Final Values)|0.83||||0.009|TWO_SIDED|95.0|0.29|1.9||The p-value is not adjusted for multiple comparisons and the a priori threshold for statistical significance is 0.05.|t-test, 2 sided||Score was lower in the Ketamine group.|||1.9|0.29|0.009
72413642|NCT00968669|144336405|SUPERIORITY_OR_OTHER|||||||0.8475|||||||Fisher Exact|||||||0.8475
72413643|NCT00968669|144336405|SUPERIORITY_OR_OTHER|||||||0.0811|||||||Fisher Exact|||||||0.0811
72413644|NCT00968669|144336405|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||||||1.0000
72413645|NCT00968669|144336406|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.938||||0.144|||||||Log Rank|Stratified by atopic asthma and steroid use||||||0.144
72413646|NCT00968669|144336406|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.618||||0.395|||||||Log Rank|Stratified by atopic asthma status and steroid use||||||0.395
72413647|NCT00968669|144336406|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.899||||0.863|||||||Log Rank|Stratified by atopic asthma status and steroid use||||||0.863
72585197|NCT02712554|144701645|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1638|||||||ANOVA|||Emax: Treatment B (high-dose CL-108) - Treatment D (high-dose M366)||||0.1638
72585198|NCT02712554|144701645|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0041|||||||ANOVA|||Emax: Treatment A (low-dose CL-108) - Placebo||||0.0041
72585199|NCT02712554|144701645|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||ANOVA|||Emax: Treatment B (high-dose CL-108) - Placebo||||<0.001
72585200|NCT02712554|144701646|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0001|||||||ANOVA|||TA\_AUE0-8hr: Treatment C (low-dose M366) - Placebo||||0.0001
72585201|NCT02712554|144701646|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||TA\_AUE0-8hr: Treatment D (high-dose M366) - Placebo||||<0.0001
72585202|NCT02712554|144701646|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2706|||||||ANOVA|||TA\_AUE0-8hr: Treatment A (low-dose CL-108) - Treatment C (low-dose M366)||||0.2706
72585203|NCT02712554|144701646|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5507|||||||ANOVA|||TA\_AUE0-8hr: Treatment B (high-dose CL-108) - Treatment D (high-dose M366)||||0.5507
72585204|NCT02712554|144701646|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0047|||||||ANOVA|||TA\_AUE0-8hr: Treatment A (low-dose CL-108) - Placebo||||0.0047
72413648|NCT00968669|144336407|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.162||||0.717|||||||Log Rank|Stratified by atopic asthma and steroid use||||||0.717
72552328|NCT02514122|144635429|SUPERIORITY||Risk Difference (RD)|0.37|||<|0.001|TWO_SIDED|95.0|0.18|0.54|||Fisher Exact|||||.54|.18|<0.001
72552329|NCT04239872|144635430|SUPERIORITY||Mean Difference (Net)|-0.00778||||0.8412|TWO_SIDED|95.0|-0.09209|0.07653||The threshold for statistical significance was set at p=0.05.|t-test, 2 sided|Paired t-test was used; there were 11 pairs of data, DF=10|Treatment difference of transformed (log10) data = Calcium mouthwash before fluoride mouthwash - Fluoride mouthwash|A paired t-test was used to compare the two groups. To obtain normal distribution, data used in the statistical analysis were transformed to the log10.||0.07653|-0.09209|0.8412
72552330|NCT04239872|144635431|SUPERIORITY||Mean Difference (Net)|-0.06907||||0.6504|TWO_SIDED|95.0|-0.3955|0.2573||The threshold for statistical significance was set at p=0.05.|t-test, 2 sided|Paired t-test was used; there were 12 pairs of data, DF=11|Treatment difference of transformed (log10) data = Calcium mouthwash before fluoride mouthwash - Fluoride mouthwash|A paired t-test was used to compare the two groups. To obtain normal distribution, data used in the statistical analysis were transformed to the log10.||0.2573|-0.3955|0.6504
72552331|NCT04239872|144635432|SUPERIORITY||Mean Difference (Net)|0.5307||||0.0024|TWO_SIDED|95.0|0.2372|0.8243||The threshold for statistical significance was set at p=0.05.|t-test, 2 sided|Paired t-test was used; there were 11 pairs of data, DF=10|Treatment difference of transformed (log10) data = Calcium mouthwash before fluoride mouthwash - Fluoride mouthwash|A paired t-test was used to compare the two groups. To obtain normal distribution, data used in the statistical analysis were transformed to the log10.||0.8243|0.2372|0.0024
72552332|NCT04239872|144635433|SUPERIORITY||Mean Difference (Net)|0.5643||||0.0013|TWO_SIDED|95.0|0.2938|0.8348||The threshold for statistical significance was set at p=0.05.|t-test, 2 sided|Paired t-test was used; there were 9 pairs of data, DF=8|Treatment difference of transformed (log10) data = Calcium mouthwash before fluoride mouthwash - Fluoride mouthwash|A paired t-test was used to compare the two groups. To obtain normal distribution, data used in the statistical analysis were transformed to the log10.||0.8348|0.2938|0.0013
72552333|NCT04239872|144635434|SUPERIORITY||Mean Difference (Net)|-0.1135||||0.2041|TWO_SIDED|95.0|-0.2964|0.06929||The threshold for statistical significance was set at p=0.05.|t-test, 2 sided|Paired t-test was used; there were 15 pairs of data, DF=14|Treatment difference of transformed (log10) data = Calcium mouthwash before fluoride mouthwash - Fluoride mouthwash|A paired t-test was used to compare the two groups. To obtain normal distribution, data used in the statistical analysis were transformed to the log10.||0.06929|-0.2964|0.2041
72585205|NCT02712554|144701646|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||TA\_AUE0-8hr: Treatment B (high-dose CL-108) - Placebo||||<0.0001
72585206|NCT02712554|144701647|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0001|||||||ANOVA|||Emin: Treatment C (low-dose M366) - Placebo||||0.0001
72585207|NCT02712554|144701647|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||Emin: Treatment D (high-dose M366) - Placebo||||<0.0001
72585208|NCT02712554|144701647|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0014|||||||ANOVA|||Emin: Treatment A (low-dose CL-108) - Treatment C (low-dose M366)||||0.0014
72585209|NCT02712554|144701647|SUPERIORITY_OR_OTHER_LEGACY|||||||0.008|||||||ANOVA|||Emin: Treatment B (high-dose CL-108) - Treatment D (high-dose M366)||||0.0080
72585210|NCT02712554|144701647|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||Emin: Treatment A (low-dose CL-108) - Placebo||||<0.0001
72585211|NCT02712554|144701647|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||Emin: Treatment B (high-dose CL-108) - Placebo||||<0.0001
72585212|NCT02712554|144701648|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0024|||||||ANOVA|||TA\_AUE0-8hr: Treatment C (low-dose M366) - Placebo||||0.0024
72585213|NCT02712554|144701648|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0012|||||||ANOVA|||TA\_AUE0-8hr: Treatment D (high-dose M366) - Placebo||||0.0012
72585214|NCT02712554|144701648|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0037|||||||ANOVA|||TA\_AUE0-8hr: Treatment A (low-dose CL-108) - Treatment C (low-dose M366)||||0.0037
72585215|NCT02712554|144701648|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0011|||||||ANOVA|||TA\_AUE0-8hr: Treatment B (high-dose CL-108) - Treatment D (high-dose M366)||||0.0011
72552334|NCT04239872|144635435|SUPERIORITY||Mean Difference (Net)|1.095|||<|0.0001|TWO_SIDED|95.0|0.7736|1.416||The threshold for statistical significance was set at p=0.05.|t-test, 2 sided|Paired t-test was used; there were 13 pairs of data, DF=12|Treatment difference of transformed (log10) data = Calcium mouthwash before fluoride mouthwash - Fluoride mouthwash|A paired t-test was used to compare the two groups. To obtain normal distribution, data used in the statistical analysis were transformed to the log10.||1.416|0.7736|<0.0001
72552335|NCT04239872|144635436|SUPERIORITY||Mean Difference (Net)|1.469|||<|0.0001|TWO_SIDED|95.0|1.112|1.825||The threshold for statistical significance was set at p=0.05.|t-test, 2 sided|Paired t-test was used; there were 13 pairs of data, DF=12|Treatment difference of transformed (log10) data = Calcium mouthwash before fluoride mouthwash - Fluoride mouthwash|A paired t-test was used to compare the two groups. To obtain normal distribution, data used in the statistical analysis were transformed to the log10.||1.825|1.112|<0.0001
72552336|NCT04239872|144635437|SUPERIORITY||Mean Difference (Net)|1.549|||<|0.0001|TWO_SIDED|95.0|1.081|2.017||The threshold for statistical significance was set at p=0.05.|t-test, 2 sided|Paired t-test was used; there were 14 pairs of data, DF=13|Treatment difference of transformed (log10) data = Calcium mouthwash before fluoride mouthwash - Fluoride mouthwash|A paired t-test was used to compare the two groups. To obtain normal distribution, data used in the statistical analysis were transformed to the log10.||2.017|1.081|<0.0001
72552337|NCT04239872|144635438|SUPERIORITY||Mean Difference (Net)|-115.6||||0.5543|TWO_SIDED|95.0|-584.8|353.6||The threshold for statistical significance was set at p=0.05.|t-test, 2 sided|Paired t-test was used; there were 6 pairs of data, DF=5|Treatment difference = Calcium mouthwash before fluoride mouthwash - Fluoride mouthwash|A paired t-test was used to compare the two groups.||353.6|-584.8|0.5543
72413649|NCT00968669|144336407|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.467||||0.07|||||||Log Rank|Stratified by atopic asthma status and steroid use||||||0.070
72552338|NCT04239872|144635439|SUPERIORITY||Mean Difference (Net)|1.328||||0.0003|TWO_SIDED|95.0|0.842|1.814||The threshold for statistical significance was set at p=0.05.|t-test, 2 sided|Paired t-test was used; there were 8 pairs of data, DF=7|Treatment difference of transformed (log10) data = Calcium mouthwash before fluoride mouthwash - Fluoride mouthwash|A paired t-test was used to compare the two groups. To obtain normal distribution, data used in the statistical analysis were transformed to the log10.||1.814|0.8420|0.0003
72552339|NCT04239872|144635440|SUPERIORITY||Mean Difference (Net)|-0.09023||||0.2824|TWO_SIDED|95.0|-0.2613|0.08082||The threshold for statistical significance was set at p=0.05.|t-test, 2 sided|Paired t-test was used; there were 19 pairs of data, DF=18|Treatment difference of transformed (log10) data = Calcium mouthwash before fluoride mouthwash - Fluoride mouthwash|A paired t-test was used to compare the two groups. To obtain normal distribution, data used in the statistical analysis were transformed to the log10.||0.08082|-0.2613|0.2824
72552340|NCT04239872|144635441|SUPERIORITY||Mean Difference (Net)|0.6269||||0.0002|TWO_SIDED|95.0|0.3488|0.905||The threshold for statistical significance was set at p=0.05.|t-test, 2 sided|Paired t-test was used; there were 17 pairs of data, DF=16|Treatment difference of transformed (log10) data = Calcium mouthwash before fluoride mouthwash - Fluoride mouthwash|A paired t-test was used to compare the two groups. To obtain normal distribution, data used in the statistical analysis were transformed to the log10.||0.9050|0.3488|0.0002
72585216|NCT02712554|144701648|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||TA\_AUE0-8hr: Treatment A (low-dose CL-108) - Placebo||||<0.0001
72585217|NCT02712554|144701648|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||TA\_AUE0-8hr: Treatment B (high-dose CL-108) - Placebo||||<0.0001
72585218|NCT02712554|144701649|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||Emax: Treatment C (low-dose M366) - Placebo||||<0.0001
72585219|NCT02712554|144701649|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||Emax: Treatment D (high-dose M366) - Placebo||||<0.0001
72413650|NCT00968669|144336407|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.955||||0.934|||||||Log Rank|Stratified by atopic asthma status and steroid use||||||0.934
72413651|NCT00968669|144336408|SUPERIORITY_OR_OTHER|||||||0.813|||||||ANOVA|||||||0.813
72585220|NCT02712554|144701649|SUPERIORITY_OR_OTHER_LEGACY|||||||0.063|||||||ANOVA|||Emax: Treatment A (low-dose CL-108) - Treatment C (low-dose M366)||||0.0630
72585221|NCT02712554|144701649|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4436|||||||ANOVA|||Emax: Treatment B (high-dose CL-108) - Treatment D (high-dose M366)||||0.4436
72585222|NCT02712554|144701649|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||Emax: Treatment A (low-dose CL-108) - Placebo||||<0.0001
72585223|NCT02712554|144701649|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||Emax: Treatment B (high-dose CL-108) - Placebo||||<0.0001
72585224|NCT02712554|144701650|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||TA\_AUE0-8hr: Treatment C (low-dose M366) - Placebo||||<0.0001
72585225|NCT02712554|144701650|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||TA\_AUE0-8hr: Treatment D (high-dose M366) - Placebo||||<0.0001
72585226|NCT02712554|144701650|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2335|||||||ANOVA|||TA\_AUE0-8hr: Treatment A (low-dose CL-108) - Treatment C (low-dose M366)||||0.2335
72585227|NCT02712554|144701650|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1808|||||||ANOVA|||TA\_AUE0-8hr: Treatment B (high-dose CL-108) - Treatment D (high-dose M366)||||0.1808
72585228|NCT02712554|144701650|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||TA\_AUE0-8hr: Treatment A (low-dose CL-108) - Placebo||||<0.0001
72585229|NCT02712554|144701650|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||TA\_AUE0-8hr: Treatment B (high-dose CL-108) - Placebo||||<0.0001
72585230|NCT02712554|144701653|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||MPC: Treatment C (low-dose M366) - Placebo||||<0.0001
72585231|NCT02712554|144701653|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||Treatment D: M366 37.5 mg/1625 mg, Treatment E: Placebo||||<0.0001
72413652|NCT00968669|144336408|SUPERIORITY_OR_OTHER|||||||0.29|||||||ANOVA|||||||0.290
72413653|NCT00968669|144336408|SUPERIORITY_OR_OTHER|||||||0.303|||||||ANOVA|||||||0.303
72585232|NCT02712554|144701653|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1268|||||||ANOVA|||MPC: Treatment A (low-dose CL-108) - Treatment C (low-dose M366)||||0.1268
72413654|NCT00968669|144336409|SUPERIORITY_OR_OTHER|||||||0.764|||||||Fisher Exact|||Combined MEDI-528 treatment was compared to placebo||||0.764
72413655|NCT00968669|144336410|SUPERIORITY_OR_OTHER|||||||0.986|||||||Fisher Exact|||Combined MEDI-528 treatment was compared to placebo||||0.986
72413656|NCT00968669|144336411|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.955||||0.7171|||||||Log Rank|Stratified by atopic asthma status and steroid use||||||0.7171
72413657|NCT00968669|144336411|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.942||||0.6219|||||||Log Rank|Stratified by atopic asthma status and steroid use||||||0.6219
72413658|NCT00968669|144336411|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.909||||0.6182|||||||Log Rank|Stratified by atopic asthma status and steroid use||||||0.6182
72585233|NCT02712554|144701653|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0014|||||||ANOVA|||MPC: Treatment B (high-dose CL-108) - Treatment D (high-dose M366)||||0.0014
72585234|NCT02712554|144701653|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||MPC: Treatment A (low-dose CL-108) - Placebo||||<0.0001
72585235|NCT02712554|144701653|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||MPC: Treatment B (high-dose CL-108) - Placebo||||<0.0001
72585236|NCT02712554|144701654|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||TA\_AUE0-8hr: Treatment C (low-dose M366) - Placebo||||<0.0001
72585237|NCT02712554|144701654|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||TA\_AUE0-8hr: Treatment D (high-dose M366) - Placebo||||<0.0001
72413659|NCT00968669|144336412|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.952||||0.712|||||||Log Rank|Stratified by atopic asthma status and steroid use||||||0.7120
72413660|NCT00968669|144336412|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.928||||0.5086|||||||Log Rank|Stratified by atopic asthma status and steroid use||||||0.5086
72413661|NCT00968669|144336412|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.887||||0.5184|||||||Log Rank|Stratified by atopic asthma status and steroid use||||||0.5184
72413662|NCT00968669|144336413|SUPERIORITY_OR_OTHER|||||||0.837|||||||Two-sample t-test|||||||0.837
72413663|NCT00968669|144336413|SUPERIORITY_OR_OTHER|||||||0.756|||||||Two-sample t-test|||||||0.756
72413664|NCT00968669|144336413|SUPERIORITY_OR_OTHER|||||||0.224|||||||Two-sample t-test|||||||0.224
72413665|NCT00968669|144336414|SUPERIORITY_OR_OTHER|||||||0.409|||||||Two-sample t-test|||||||0.409
72413666|NCT00968669|144336414|SUPERIORITY_OR_OTHER|||||||0.847|||||||Two-sample t-test|||||||0.847
72413667|NCT00968669|144336414|SUPERIORITY_OR_OTHER|||||||0.968|||||||Two-sample t-test|||||||0.968
72413668|NCT00968669|144336415|SUPERIORITY_OR_OTHER|||||||0.208|||||||Fisher Exact|||Combined MEDI-528 dose groups versus placebo||||0.208
72413669|NCT00968669|144336416|SUPERIORITY_OR_OTHER|||||||0.574|||||||Fisher Exact|||Combined MEDI-528 dose groups versus placebo||||0.574
72413670|NCT00144339|144336422|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|2.0||0.9524||95.0|-4.0|4.0|||t-test, 2 sided|Random-effects model|Arbitrary covariance matrix; fixed treatment effect; individual patients are random; rate of decline estimated as the slope of the random effects model|Linear random effects model||4|-4|0.9524
72413671|NCT00144339|144336423|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.0|STANDARD_ERROR_OF_MEAN|2.0||0.2074||95.0|-2.0|6.0|||t-test, 2 sided|Random-effects model|Arbitrary covariance matrix; fixed treatment effect; individual patients are random; rate of decline estimated as the slope of the random effects model|Linear random effects model||6|-2|0.2074
72413672|NCT00144339|144336424|SUPERIORITY_OR_OTHER|||||||0.2488||95.0|||||Wilcoxon Rank-sum test|Rate calculated as (measure on 30days after completion of treatment - measure on day 1 )/ years in between||||||0.2488
72413673|NCT00144339|144336425|SUPERIORITY_OR_OTHER|||||||0.0145||95.0|||||Wilcoxon Rank-sum test|Rate calculated as (measure on 30days after completion of treatment - measure on day 1 )/ years in between||||||0.0145
72413674|NCT00144339|144336426|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.0|STANDARD_ERROR_OF_MEAN|4.0||0.299||95.0|-12.0|4.0|||t-test, 2 sided||Arbitrary covariance matrix; fixed treatment effect; individual patients are random; rate of decline estimated as the slope of the random effects model|Linear random effects model||4|-12|0.2990
72413675|NCT00144339|144336427|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0|STANDARD_ERROR_OF_MEAN|4.0||0.8375||95.0|-9.0|7.0|||t-test, 2 sided||Arbitrary covariance matrix; fixed treatment effect; individual patients are random; rate of decline estimated as the slope of the random effects model|Linear random effects model||7|-9|0.8375
72585238|NCT02712554|144701654|SUPERIORITY_OR_OTHER_LEGACY|||||||0.012|||||||ANOVA|||TA\_AUE0-8hr: Treatment A (low-dose CL-108) - Treatment C (low-dose M366)||||0.0120
72585239|NCT02712554|144701654|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||TA\_AUE0-8hr: Treatment B (high-dose CL-108) - Treatment D (high-dose M366)||||<0.0001
72585240|NCT02712554|144701654|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||TA\_AUE0-8hr: Treatment A (low-dose CL-108) - Placebo||||<0.0001
72585241|NCT02712554|144701654|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||TA\_AUE0-8hr: Treatment B (high-dose CL-108) - Placebo||||<0.0001
72585242|NCT01624740|144701680|SUPERIORITY_OR_OTHER|||||||0.74|TWO_SIDED||||||ANOVA|Period effect p=0.11||||||0.74
72585243|NCT01102257|144701699|SUPERIORITY_OR_OTHER|||||||0.03||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.03
72585244|NCT01894841|144701720|SUPERIORITY||Partial eta squared|0.03||||0.13|TWO_SIDED|||||Adjusted for change in depression from baseline to 1yr (measured via QIDS).|RMANOVA|||||||.13
72585245|NCT01894841|144701721|SUPERIORITY||Partial eta squared|0.01||||0.79|TWO_SIDED||||||RMANOVA|Adjusted for change in depression from baseline to 1yr (measured via QIDS).||||||.79
72585246|NCT01894841|144701722|SUPERIORITY||Partial eta squared|0.02||||0.49|TWO_SIDED|||||Adjusted for change in depression from baseline to 1yr (measured via QIDS).|RMANOVA|||||||.49
72585247|NCT01894841|144701723|SUPERIORITY||Partial eta-squared|0.003||||0.96|TWO_SIDED|||||Adjusted for change in depression from baseline to 1yr (measured via QIDS).|RMANOVA|||||||.96
72585248|NCT01894841|144701724|SUPERIORITY||Partial eta squared|0.01||||0.62|TWO_SIDED||||||RMANOVA|Adjusted for change in depression from baseline to 1yr (measured via QIDS).||||||.62
72585249|NCT00529087|144701742|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|24.4|||<|0.001||95.0|17.3|31.4|||Chi-squared|||||31.4|17.3|<0.001
72413676|NCT00144339|144336428|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-6.0|STANDARD_ERROR_OF_MEAN|4.0||0.1143||95.0|-14.0|2.0|||t-test, 2 sided||Arbitrary covariance matrix; fixed treatment effect; individual patients are random; rate of decline estimated as the slope of the random effects model|Linear random effects model||2|-14|0.1143
72413677|NCT00144339|144336429|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-1.0|STANDARD_ERROR_OF_MEAN|4.0||0.787||95.0|-9.0|7.0|||t-test, 2 sided||Arbitrary covariance matrix; fixed treatment effect; individual patients are random; rate of decline estimated as the slope of the random effects model|Linear random effects model||7|-9|0.7870
72413678|NCT00144339|144336430|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.04|STANDARD_ERROR_OF_MEAN|0.13||0.784||95.0|-0.2|0.3|||t-test, 2 sided||Arbitrary covariance matrix; fixed treatment effect; individual patients are random; rate of decline estimated as the slope of the random effects model|Linear random effects model||0.3|-0.2|0.7840
72413679|NCT00144339|144336431|SUPERIORITY_OR_OTHER|||||||0.2705||95.0|||||Wilcoxon Rank-sum test|Rate calculated as (measure on 30days after completion of treatment - measure on day 1 )/ years in between||||||0.2705
72413680|NCT00144339|144336432|SUPERIORITY_OR_OTHER|||||||0.306||95.0|||||Wilcoxon Rank-sum test|Rate calculated as (measure on 30days after completion of treatment - measure on day 1 )/ years in between||||||0.306
72413681|NCT00144339|144336433|SUPERIORITY_OR_OTHER|||||||0.8103||95.0|||||Wilcoxon Rank-sum test|Rate calculated as (measure on 30days after completion of treatment - measure on day 1 )/ years in between||||||0.8103
72585250|NCT00529087|144701743|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|19.5|||<|0.001||95.0|15.1|24.0|||t-test, 2 sided|||||24.0|15.1|<0.001
72585251|NCT00529087|144701743|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|20.9|||<|0.001||95.0|16.1|25.7|||t-test, 2 sided|||||25.7|16.1|<0.001
72585252|NCT00529087|144701744|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Log Rank|Log-rank test for comparisons of survival distributions||||||<0.001
72585253|NCT00529087|144701745|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|1.6|||<|0.001||95.0|1.1|2.1|||ANCOVA|Treatment as factor and baseline weekly RFBM as covariate||||2.1|1.1|<0.001
72585254|NCT00529087|144701745|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|0.7||||0.011||95.0|0.2|1.2|||ANCOVA|Treatment as factor and baseline weekly RFBM as covariate||||1.2|0.2|0.011
72585255|NCT00529087|144701747|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|20.4|||<|0.001||95.0|9.5|31.3|||Chi-squared|||||31.3|9.5|<0.001
72585256|NCT00529087|144701747|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|7.0||||0.212||95.0|-4.0|18.0|||Chi-squared|||||18.0|-4.0|0.212
72585257|NCT00529087|144701748|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||t-test, 2 sided|||The statistical analysis for all time points (1, 2, 3 and 6 hours) is only shown once as the p value is the same for all time points.||||<0.001
72585258|NCT00529087|144701748|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||t-test, 2 sided|||The statistical analysis for all time points (1, 2, 3 and 6 hours) is only shown once as the p value is the same for all time points.||||<0.001
72585259|NCT00529087|144701749|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|14.5|||<|0.001||95.0|11.2|17.9|||ANOVA|Treatment as a factor||1 hour||17.9|11.2|<0.001
72585260|NCT00529087|144701749|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|8.0|||<|0.001||95.0|4.6|11.4|||ANOVA|Treatment as a factor||1 hour||11.4|4.6|<0.001
72585261|NCT00529087|144701749|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|18.5|||<|0.001||95.0|14.4|22.5|||ANOVA|Treatment as a factor||2 hours||22.5|14.4|<0.001
72585262|NCT00529087|144701749|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|10.4|||<|0.001||95.0|6.3|14.5|||ANOVA|Treatment as a factor||2 hours||14.5|6.3|<0.001
72585263|NCT00529087|144701749|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|19.3|||<|0.001||95.0|15.0|23.5|||ANOVA|Treatment as a factor||3 hours||23.5|15.0|<0.001
72585264|NCT00529087|144701749|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|11.0|||<|0.001||95.0|6.7|15.3|||ANOVA|Treatment as a factor||3 hours||15.3|6.7|<0.001
72585265|NCT00529087|144701749|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|19.5|||<|0.001||95.0|15.2|23.9|||ANOVA|Treatment as a factor||4 hours||23.9|15.2|<0.001
72585266|NCT00529087|144701749|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|11.0|||<|0.001||95.0|6.6|15.4|||ANOVA|Treatment as a factor||4 hours||15.4|6.6|<0.001
72585267|NCT00529087|144701749|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|19.7|||<|0.001||95.0|15.2|24.1|||ANOVA|Treatment as a factor||6 hours||24.1|15.2|<0.001
72585268|NCT00529087|144701749|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|10.7|||<|0.001||95.0|6.2|15.2|||ANOVA|Treatment as a factor||6 hours||15.2|6.2|<0.001
72585269|NCT00529087|144701750|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|21.0|||<|0.001||95.0|10.2|31.9|||Chi-squared|||||31.9|10.2|<0.001
72585270|NCT00529087|144701750|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|5.6||||0.316||95.0|-5.3|16.5|||Chi-squared|||||16.5|-5.3|0.316
72585271|NCT00529087|144701751|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|19.7|||<|0.001||95.0|9.4|30.1|||Chi-squared|||||30.1|9.4|<0.001
72585272|NCT00529087|144701751|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|13.3||||0.016||95.0|2.6|24.0|||Chi-squared|||||24.0|2.6|0.016
72585273|NCT00529087|144701752|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.4|||<|0.001||95.0|1.0|1.9|||ANCOVA|Treatment as factor, Baseline as covariate||||1.9|1.0|<0.001
72585274|NCT00529087|144701752|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.4||||0.102||95.0|-0.1|0.8|||ANCOVA|Treatment as factor, Baseline as covariate||||0.8|-0.1|0.102
72585275|NCT00529087|144701753|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|1.1|||<|0.001||95.0|0.6|1.5|||ANCOVA|||||1.5|0.6|<0.001
72585276|NCT00529087|144701753|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|0.4|||<|0.001||95.0|0.0|0.9|||ANCOVA|||||0.9|0.0|<0.001
72585277|NCT00529087|144701754|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.2|||<|0.001||95.0|0.8|1.6|||ANCOVA|Treatment as factor, Baseline as covariate||||1.6|0.8|<0.001
72585278|NCT00529087|144701754|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.5||||0.012||95.0|0.1|0.9|||ANCOVA|Treatment as factor, Baseline as covariate||||0.9|0.1|0.012
72585279|NCT00529087|144701755|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.5||||0.002||95.0|0.2|0.7|||ANCOVA|Treatment as factor, Baseline as covariate||||0.7|0.2|0.002
72585280|NCT00529087|144701755|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.2||||0.119||95.0|-0.1|0.5|||ANCOVA|Treatment as factor, Baseline as covariate||||0.5|-0.1|0.119
72585281|NCT00529087|144701756|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|-0.3||||0.008||95.0|-0.5|-0.1|||ANCOVA|Treatment as factor, Baseline as covariate||||-0.1|-0.5|0.008
72585282|NCT00529087|144701756|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|-0.2||||0.015||95.0|-0.5|0.0|||ANCOVA|Treatment as factor, Baseline as covariate||||0.0|-0.5|0.015
72585283|NCT00529087|144701759|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.1||||0.731||95.0|-5.4|7.7|||ANCOVA|Treatment as factor, Baseline as covariate||||7.7|-5.4|0.731
72585284|NCT00529087|144701759|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.9||||0.779||95.0|-5.6|7.5|||ANCOVA|Treatment as factor, Baseline as covariate||||7.5|-5.6|0.779
72585285|NCT00529087|144701760|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|5.6||||0.023||95.0|0.8|10.4|||ANCOVA|Treatment as factor, baseline as covariate||||10.4|0.8|0.023
72585286|NCT00529087|144701760|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|2.8||||0.258||95.0|-2.0|7.6|||ANCOVA|Treatment as factor, baseline as covariate||||7.6|-2.0|0.258
72585287|NCT00529087|144701762|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|7.0||||0.071||95.0|-0.6|14.5|||ANCOVA|Treatment as factor, baseline as covariate||||14.5|-0.6|0.071
72585288|NCT00529087|144701762|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|6.6||||0.087||95.0|-1.0|14.2|||ANCOVA|Treatment as factor, baseline as covariate||||14.2|-1.0|0.087
72585289|NCT00529087|144701763|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|7.6||||0.038||95.0|0.4|14.7|||ANCOVA|Treatment as factor, baseline as covariate||||14.7|0.4|0.038
72585290|NCT00529087|144701763|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.3||||0.237||95.0|-2.8|11.5|||ANCOVA|Treatment as factor, baseline as covariate||||11.5|-2.8|0.237
72585291|NCT00708552|144701801|SUPERIORITY||Mean Difference (Net)|1.1||||0.159|TWO_SIDED|95.0|-0.4|2.7|||Mixed model repeated measures|||ADAS-Cog Total Score, Placebo Vs SB-742457-15mg at Week 24||2.7|-0.4|0.159
72413682|NCT00144339|144336434|SUPERIORITY_OR_OTHER|||||||0.9814||95.0|||||Wilcoxon Rank-sum test|Rate calculated as (measure on 30days after completion of treatment - measure on day 1 )/ years in between||||||0.9814
72585292|NCT00708552|144701801|SUPERIORITY||Mean Difference (Net)|0.7||||0.41|TWO_SIDED|95.0|-0.9|2.3|||Mixed model repeated measures|||ADAS-Cog Total Score, Placebo Vs SB-742457-35mg at Week 24||2.3|-0.9|0.410
72585293|NCT00708552|144701801|SUPERIORITY||Mean Difference (Net)|-0.2||||0.821|TWO_SIDED|95.0|-1.6|1.2|||Mixed model repeated measures|||ADAS-Cog Total Score, Placebo Vs Donepezil at Week 24||1.2|-1.6|0.821
72585294|NCT00708552|144701802|SUPERIORITY||Mean Difference (Net)|0.2||||0.254|TWO_SIDED|95.0|-0.1|0.5|||Mixed model repeated measures|||CIBIC+ Score, Placebo Vs SB-742457-15mg at Week 24||0.5|-0.1|0.254
72585295|NCT00708552|144701802|SUPERIORITY||Mean Difference (Net)|-0.1||||0.394|TWO_SIDED|95.0|-0.4|0.2|||Mixed model repeated measures|||CIBIC+ Score, Placebo Vs SB-742457-35mg at Week 24||0.2|-0.4|0.394
72585296|NCT00708552|144701802|SUPERIORITY||Mean Difference (Net)|-0.3||||0.049|TWO_SIDED|95.0|-0.6|0.0|||Mixed model repeated measures|||CIBIC+ Score, Placebo Vs Donepezil at Week 24||-0.0|-0.6|0.049
72585297|NCT00708552|144701803|SUPERIORITY||Mean Difference (Net)|-1.6||||0.423|TWO_SIDED|95.0|-5.6|2.3|||Mixed model repeated measures|||RBANS Total Score, Placebo Vs SB-742457-15mg at Week 24||2.3|-5.6|0.423
72585298|NCT00708552|144701803|SUPERIORITY||Mean Difference (Net)|-2.1||||0.305|TWO_SIDED|95.0|-6.1|1.9|||Mixed model repeated measures|||RBANS Total Score, Placebo Vs SB-742457-35mg at Week 24||1.9|-6.1|0.305
72585299|NCT00708552|144701803|SUPERIORITY||Mean Difference (Net)|2.0||||0.282|TWO_SIDED|95.0|-1.7|5.7|||Mixed model repeated measures|||RBANS Total Score, Placebo Vs Donepezil at Week 24||5.7|-1.7|0.282
72585300|NCT00708552|144701804|SUPERIORITY||Mean Difference (Net)|1.4||||0.096|TWO_SIDED|95.0|-0.3|3.1|||Mixed model repeated measures|||Baseline MMSE score of 16-26 on ADAS-Cog Total score, Placebo Vs SB-742457-15mg at Week 24||3.1|-0.3|0.096
72585301|NCT00708552|144701804|SUPERIORITY||Mean Difference (Net)|1.0||||0.281|TWO_SIDED|95.0|-0.8|2.8|||Mixed model repeated measures|||Baseline MMSE score of 16-26 on ADAS-Cog Total score, Placebo Vs SB-742457-35mg at Week 24||2.8|-0.8|0.281
72585302|NCT00708552|144701804|SUPERIORITY||Mean Difference (Net)|0.4||||0.63|TWO_SIDED|95.0|-1.1|1.9|||Mixed model repeated measures|||Baseline MMSE score of 16-26 on ADAS-Cog Total score, Placebo Vs Donepezil at Week 24||1.9|-1.1|0.630
72585303|NCT00708552|144701804|SUPERIORITY||Mean Difference (Net)|-1.1||||0.655|TWO_SIDED|95.0|-5.7|3.6|||Mixed model repeated measures|||Baseline MMSE score of 16-26 on RBANS Total score, Placebo Vs SB-742457-15mg at Week 24||3.6|-5.7|0.655
72585304|NCT00708552|144701804|SUPERIORITY||Mean Difference (Net)|-1.5||||0.545|TWO_SIDED|95.0|-6.2|3.3|||Mixed model repeated measures|||Baseline MMSE score of 16-26 on RBANS Total score, Placebo Vs SB-742457-35mg at Week 24||3.3|-6.2|0.545
72585305|NCT00708552|144701804|SUPERIORITY||Mean Difference (Net)|2.4||||0.27|TWO_SIDED|95.0|-1.9|6.8|||Mixed model repeated measures|||Baseline MMSE score of 16-26 on RBANS Total score, Placebo Vs Donepezil at Week 24||6.8|-1.9|0.270
72413683|NCT00144339|144336435|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.86|STANDARD_ERROR_OF_MEAN|0.03|<|0.0001||95.0|0.81|0.91|||Log Rank|Cox regression with treatment|Median estimated by Kaplan-Meier estimates; hazard ratio shown as tio vs. placebo|Cox regression||0.91|0.81|<0.0001
72585306|NCT00708552|144701805|SUPERIORITY||Mean Difference (Net)|1.5||||0.138|TWO_SIDED|95.0|-0.5|3.6|||Mixed model repeated measures|||Baseline MMSE score of 10-20 on ADAS-Cog Total score, Placebo Vs SB-742457-15mg at Week 24||3.6|-0.5|0.138
72585307|NCT00708552|144701805|SUPERIORITY||Mean Difference (Net)|1.3||||0.216|TWO_SIDED|95.0|-0.7|3.2|||Mixed model repeated measures|||Baseline MMSE score of 10-20 on ADAS-Cog Total score, Placebo Vs SB-742457-35mg at Week 24||3.2|-0.7|0.216
72585308|NCT00708552|144701805|SUPERIORITY||Mean Difference (Net)|-0.1||||0.921|TWO_SIDED|95.0|-1.9|1.7|||Mixed model repeated measures|||Baseline MMSE score of 10-20 on ADAS-Cog Total score, Placebo Vs Donepezil at Week 24||1.7|-1.9|0.921
72585309|NCT00708552|144701805|SUPERIORITY||Mean Difference (Net)|-2.1||||0.41|TWO_SIDED|95.0|-7.0|2.9|||Mixed model repeated measures|||Baseline MMSE score of 10-20 on RBANS Total score, Placebo Vs SB-742457-15mg at Week 24||2.9|-7.0|0.410
72585310|NCT00708552|144701805|SUPERIORITY||Mean Difference (Net)|-1.1||||0.667|TWO_SIDED|95.0|-5.9|3.8|||Mixed model repeated measures|||Baseline MMSE score of 10-20 on RBANS Total score, Placebo Vs SB-742457-35mg at Week 24||3.8|-5.9|0.667
72585311|NCT00708552|144701805|SUPERIORITY||Mean Difference (Net)|2.7||||0.246|TWO_SIDED|95.0|-1.9|7.2|||Mixed model repeated measures|||Baseline MMSE score of 10-20 on RBANS Total score, Placebo Vs Donepezil at Week 24||7.2|-1.9|0.246
72585312|NCT00708552|144701806|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.146|TWO_SIDED|95.0|-0.1|0.6|||Mixed model repeated measures|||Baseline MMSE score of 16-26 on CBIC+ score, Placebo Vs SB-742457-15mg at Week 24||0.6|-0.1|0.146
72585313|NCT00708552|144701806|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.733|TWO_SIDED|95.0|-0.4|0.3|||Mixed model repeated measures|||Baseline MMSE score of 16-26 on CBIC+ score, Placebo Vs SB-742457-35mg at Week 24||0.3|-0.4|0.733
72585314|NCT00708552|144701806|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.145|TWO_SIDED|95.0|-0.5|0.1|||Mixed model repeated measures|||Baseline MMSE score of 16-26 on CBIC+ score, Placebo Vs Donepezil at Week 24||0.1|-0.5|0.145
72585315|NCT00708552|144701807|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.295|TWO_SIDED|95.0|-0.2|0.6|||Mixed model repeated measures|||Baseline MMSE score of 16-26 on CBIC+, Placebo Vs SB-742457-15mg at Week 24||0.6|-0.2|0.295
72585316|NCT00708552|144701807|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.495|TWO_SIDED|95.0|-0.5|0.2|||Mixed model repeated measures|||Baseline MMSE score of 16-26 on CBIC+, Placebo Vs SB-742457-35mg at Week 24||0.2|-0.5|0.495
72585317|NCT00708552|144701807|SUPERIORITY||Mean Difference (Net)|-0.3||||0.166|TWO_SIDED|95.0|-0.6|0.1|||Mixed model repeated measures|||Baseline MMSE score of 16-26 on CBIC+, Placebo Vs Donepezil at Week 24||0.1|-0.6|0.166
72413684|NCT00144339|144336436|SUPERIORITY_OR_OTHER||Rate Ratio|0.86|STANDARD_ERROR_OF_MEAN|0.03|<|0.0001||95.0|0.81|0.91|||t-test, 2 sided||Ratio calculated as estimated number of events in tio/number of events in placebo|Poisson regression adjusted for overdispersion and treatment exposure||0.91|0.81|<0.0001
72585318|NCT00708552|144701808|SUPERIORITY||Mean Difference (Net)|0.1||||0.847|TWO_SIDED|95.0|-1.1|1.4|||Mixed model repeated measures|||ADAS-Cog Total Score, Placebo Vs SB-742457-15mg at Week 12||1.4|-1.1|0.847
72413685|NCT00144339|144336437|SUPERIORITY_OR_OTHER|||||||0.3481||95.0|||||Fisher Exact|||||||0.3481
72585319|NCT00708552|144701808|SUPERIORITY||Mean Difference (Net)|-0.1||||0.833|TWO_SIDED|95.0|-1.4|1.1|||Mixed Models Analysis|||ADAS-Cog Total Score, Placebo Vs SB-742457-35mg at Week 12||1.1|-1.4|0.833
72585320|NCT00708552|144701808|SUPERIORITY||Mean Difference (Net)|-0.5||||0.443|TWO_SIDED|95.0|-1.6|0.7|||Mixed model repeated measures|||ADAS-Cog Total Score, Placebo Vs Donepzil at Week 12||0.7|-1.6|0.443
72585321|NCT00708552|144701809|SUPERIORITY||Mean Difference (Net)|0.1||||0.32|TWO_SIDED|95.0|-0.1|0.3|||Mixed model repeated measures|||CIBIC+ Score, Placebo Vs SB-742457-15mg at Week 12||0.3|-0.1|0.320
72585322|NCT00708552|144701809|SUPERIORITY||Mean Difference (Net)|0.0||||0.927|TWO_SIDED|95.0|-0.2|0.2|||Mixed model repeated measures|||CIBIC+ Score, Placebo Vs SB-742457-35mg at Week 12||0.2|-0.2|0.927
72585323|NCT00708552|144701809|SUPERIORITY||Mean Difference (Net)|-0.2||||0.059|TWO_SIDED|95.0|-0.4|0.0|||Mixed model repeated measures|||CIBIC+ Score, Placebo Vs Donepzil at Week 12||0.0|-0.4|0.059
72585324|NCT00708552|144701810|SUPERIORITY||Mean Difference (Net)|-1.9||||0.257|TWO_SIDED|95.0|-5.2|1.4|||Mixed model repeated measures|||RBANS total score, Placebo Vs SB-742457-15mg at Week 12||1.4|-5.2|0.257
72585325|NCT00708552|144701810|SUPERIORITY||Mean Difference (Net)|0.9||||0.57|TWO_SIDED|95.0|-2.2|4.0|||Mixed model repeated measures|||RBANS total score, Placebo Vs SB-742457-35mg at Week 12||4.0|-2.2|0.570
72585326|NCT00708552|144701810|SUPERIORITY||Mean Difference (Net)|3.4||||0.031|TWO_SIDED|95.0|0.3|6.4|||Mixed model repeated measures|||RBANS total score, Placebo Vs Donepzil at Week 12||6.4|0.3|0.031
72585327|NCT00708552|144701811|SUPERIORITY||Mean Difference (Net)|0.2||||0.798|TWO_SIDED|95.0|-1.1|1.5|||Mixed model repeated measures|||Baseline MMSE score of 16-26 on ADAS-Cog Total score, Placebo Vs SB-742457-15mg at Week 12||1.5|-1.1|0.798
72585328|NCT00708552|144701811|SUPERIORITY||Mean Difference (Net)|0.1||||0.918|TWO_SIDED|95.0|-1.3|1.4|||Mixed model repeated measures|||Baseline MMSE score of 16-26 on ADAS-Cog Total score, Placebo Vs SB-742457-35mg at Week 12||1.4|-1.3|0.918
72585329|NCT00708552|144701811|SUPERIORITY||Mean Difference (Net)|0.1||||0.924|TWO_SIDED|95.0|-1.2|1.3|||Mixed model repeated measures|||Baseline MMSE score of 16-26 on ADAS-Cog Total score, Placebo Vs Donepezil at Week 12||1.3|-1.2|0.924
72585330|NCT00708552|144701811|SUPERIORITY||Mean Difference (Net)|-0.8||||0.676|TWO_SIDED|95.0|-4.7|3.0|||Mixed model repeated measures|||Baseline MMSE score of 16-26 on RBANS Total score, Placebo Vs SB-742457-15mg at Week 12||3.0|-4.7|0.676
72585331|NCT00708552|144701811|SUPERIORITY||Mean Difference (Net)|3.1||||0.086|TWO_SIDED|95.0|-0.4|6.7|||Mixed model repeated measures|||Baseline MMSE score of 16-26 on RBANS Total score, Placebo Vs SB-742457-35mg at Week 12||6.7|-0.4|0.086
72585332|NCT00708552|144701811|SUPERIORITY||Mean Difference (Net)|4.2||||0.021|TWO_SIDED|95.0|0.6|7.7|||Mixed model repeated measures|||Baseline MMSE score of 16-26 on RBANS Total score, Placebo Vs Donepezil at Week 12||7.7|0.6|0.021
72585333|NCT00708552|144701812|SUPERIORITY||Mean Difference (Net)|0.1||||0.908|TWO_SIDED|95.0|-1.5|1.7|||Mixed model repeated measures|||Baseline MMSE score of 10-20 on ADAS-Cog Total score, Placebo Vs SB-742457-15mg at Week 12||1.7|-1.5|0.908
72585334|NCT00708552|144701812|SUPERIORITY||Mean Difference (Net)|-0.2||||0.826|TWO_SIDED|95.0|-1.7|1.4|||Mixed model repeated measures|||Baseline MMSE score of 10-20 on ADAS-Cog Total score, Placebo Vs SB-742457-35mg at Week 12||1.4|-1.7|0.826
72585335|NCT00708552|144701812|SUPERIORITY||Mean Difference (Net)|-1.2||||0.088|TWO_SIDED|95.0|-2.7|0.2|||Mixed model repeated measures|||Baseline MMSE score of 10-20 on ADAS-Cog Total score, Placebo Vs Donepezil at Week 12||0.2|-2.7|0.088
72585336|NCT00708552|144701812|SUPERIORITY||Mean Difference (Net)|-3.6||||0.053|TWO_SIDED|95.0|-7.3|0.0|||Mixed model repeated measures|||Baseline MMSE score of 10-20 on RBANS Total score, Placebo Vs SB-742457-15mg at Week 12||0.0|-7.3|0.053
72585337|NCT00708552|144701812|SUPERIORITY||Mean Difference (Net)|-0.4||||0.848|TWO_SIDED|95.0|-4.0|3.3|||Mixed Models Analysis|||Baseline MMSE score of 10-20 on RBANS Total score, Placebo Vs SB-742457-35mg at Week 12||3.3|-4.0|0.848
72585338|NCT00708552|144701812|SUPERIORITY||Mean Difference (Net)|4.7||||0.011|TWO_SIDED|95.0|1.1|8.2|||Mixed model repeated measures|||Baseline MMSE score of 10-20 on RBANS Total score, Placebo Vs Donepezil at Week 12||8.2|1.1|0.011
72585339|NCT00708552|144701813|SUPERIORITY||Mean Difference (Net)|0.1||||0.671|TWO_SIDED|95.0|-0.2|0.3|||Mixed model repeated measures|||Baseline MMSE score of 16-26 on CIBIC+ score, Placebo Vs SB-742457-15mg at Week 12||0.3|-0.2|0.671
72585340|NCT00708552|144701813|SUPERIORITY||Mean Difference (Net)|-0.1||||0.413|TWO_SIDED|95.0|-0.4|0.2|||Mixed model repeated measures|||Baseline MMSE score of 16-26 on CIBIC+ Total score, Placebo Vs SB-742457-35mg at Week 12||0.2|-0.4|0.413
72585341|NCT00708552|144701813|SUPERIORITY||Mean Difference (Net)|-0.1||||0.245|TWO_SIDED|95.0|-0.4|0.1|||Mixed model repeated measures|||Baseline MMSE score of 16-26 on CIBIC+ Total score, Placebo Vs Donepezil at Week 12||0.1|-0.4|0.245
72585342|NCT00708552|144701814|SUPERIORITY||Mean Difference (Net)|0.1||||0.369|TWO_SIDED|95.0|-0.2|0.4|||Mixed model repeated measures|||Baseline MMSE score of 10-20 on CIBIC+ score, Placebo Vs SB-742457-15mg at Week 12||0.4|-0.2|0.369
72585343|NCT00708552|144701814|SUPERIORITY||Mean Difference (Net)|0.1||||0.55|TWO_SIDED|95.0|-0.2|0.4|||Mixed model repeated measures|||Baseline MMSE score of 10-20 on CIBIC+ Total score, Placebo Vs SB-742457-35mg at Week 12||0.4|-0.2|0.550
72585344|NCT00708552|144701814|SUPERIORITY||Mean Difference (Net)|-0.3||||0.082|TWO_SIDED|95.0|-0.5|0.0|||Mixed model repeated measures|||Baseline MMSE score of 10-20 on CIBIC+ Total score, Placebo Vs Donepezil at Week 12||0.0|-0.5|0.082
72585345|NCT00708552|144701815|SUPERIORITY||Mean Difference (Net)|-0.7||||0.417|TWO_SIDED|95.0|-2.4|1.0|||Mixed model repeated measures|||ADCS-ADL Total score, Placebo Vs SB-742457-15mg at Week 12||1.0|-2.4|0.417
72585346|NCT00708552|144701815|SUPERIORITY||Mean Difference (Net)|0.3||||0.725|TWO_SIDED|95.0|-1.4|2.0|||Mixed model repeated measures|||ADCS-ADL Total score, Placebo Vs SB-742457-35mg at Week 12||2.0|-1.4|0.725
72585347|NCT00708552|144701815|SUPERIORITY||Mean Difference (Net)|0.6||||0.506|TWO_SIDED|95.0|-1.1|2.2|||Mixed model repeated measures|||ADCS-ADL Total score, Placebo Vs Donepezil at Week 12||2.2|-1.1|0.506
72585348|NCT00708552|144701815|SUPERIORITY||Mean Difference (Net)|-0.3||||0.723|TWO_SIDED|95.0|-2.3|1.6|||Mixed model repeated measures|||ADCS-ADL Total score, Placebo Vs SB-742457-15mg at Week 24||1.6|-2.3|0.723
72585349|NCT00708552|144701815|SUPERIORITY||Median Difference (Net)|-0.1||||0.919|TWO_SIDED|95.0|-2.2|2.0|||Mixed model repeated measures|||ADCS-ADL Total score, Placebo Vs SB-742457-35mg at Week 24||2.0|-2.2|0.919
72585350|NCT00708552|144701815|SUPERIORITY||Mean Difference (Net)|-0.1||||0.896|TWO_SIDED|95.0|-2.3|2.0|||Mixed model repeated measures|||ADCS-ADL Total score, Placebo Vs Donepezil at Week 24||2.0|-2.3|0.896
72585351|NCT00708552|144701816|SUPERIORITY||Mean Difference (Net)|-0.2||||0.594|TWO_SIDED|95.0|-0.9|0.5|||ANCOVA|||CSDD Total score, Placebo Vs SB-742457-15mg at Week 24||0.5|-0.9|0.594
72585352|NCT00708552|144701816|SUPERIORITY||Mean Difference (Net)|0.2||||0.523|TWO_SIDED|95.0|-0.5|0.9|||ANCOVA|||CSDD Total score, Placebo Vs SB-742457-35mg at Week 24||0.9|-0.5|0.523
72585353|NCT00708552|144701816|SUPERIORITY||Mean Difference (Net)|0.3||||0.429|TWO_SIDED|95.0|-0.4|1.0|||ANCOVA|||CSDD Total score, Placebo Vs Donepezil at Week 24||1.0|-0.4|0.429
72585354|NCT00708552|144701817|SUPERIORITY||Mean Difference (Net)|0.0||||0.966|TWO_SIDED|95.0|-0.8|0.8|||ANCOVA|||MMSE Total score, Placebo Vs SB-742457-15mg at Week 24||0.8|-0.8|0.966
72585355|NCT00708552|144701817|SUPERIORITY||Mean Difference (Net)|0.3||||0.505|TWO_SIDED|95.0|-0.5|1.1|||ANCOVA|||MMSE Total score, Placebo Vs SB-742457-35mg at Week 24||1.1|-0.5|0.505
72585356|NCT00708552|144701817|SUPERIORITY||Mean Difference (Net)|0.8||||0.044|TWO_SIDED|95.0|0.0|1.6|||ANCOVA|||MMSE Total score, Placebo Vs Donepezil at Week 24||1.6|0.0|0.044
72585357|NCT00708552|144701818|SUPERIORITY||Mean Difference (Net)|0.0||||0.869|TWO_SIDED|95.0|-0.5|0.5|||Mixed model repeated measures|||Basic Score, Placebo Vs SB-742457-15mg at Week 12||0.5|-0.5|0.869
72585358|NCT00708552|144701818|SUPERIORITY||Mean Difference (Net)|0.2||||0.5|TWO_SIDED|95.0|-0.4|0.8|||Mixed model repeated measures|||Basic Score, Placebo Vs SB-742457-35mg at Week 12||0.8|-0.4|0.500
72585359|NCT00708552|144701818|SUPERIORITY||Mean Difference (Net)|0.3||||0.14|TWO_SIDED|95.0|-0.1|0.8|||Mixed model repeated measures|||Basic Score, Placebo Vs Donepezil at Week 12||0.8|-0.1|0.140
72585360|NCT00708552|144701818|SUPERIORITY||Mean Difference (Net)|0.0||||0.91|TWO_SIDED|95.0|-0.6|0.5|||Mixed model repeated measures|||Basic Score, Placebo Vs SB-742457-15mg at Week 24||0.5|-0.6|0.910
72585361|NCT00708552|144701818|SUPERIORITY||Mean Difference (Net)|0.1||||0.774|TWO_SIDED|95.0|-0.5|0.7|||Mixed model repeated measures|||Basic Score, Placebo Vs SB-742457-35mg at Week 24||0.7|-0.5|0.774
72585362|NCT00708552|144701818|SUPERIORITY||Mean Difference (Net)|-0.1||||0.726|TWO_SIDED|95.0|-0.7|0.5|||Mixed model repeated measures|||Basic Score, Placebo Vs Donepezil at Week 24||0.5|-0.7|0.726
72585363|NCT00708552|144701818|SUPERIORITY||Mean Difference (Net)|-0.8||||0.292|TWO_SIDED|95.0|-2.2|0.7|||Mixed model repeated measures|||Instrumental Score, Placebo Vs SB-742457-15mg at Week 12||0.7|-2.2|0.292
72585364|NCT00708552|144701818|SUPERIORITY||Mean Difference (Net)|0.0||||0.946|TWO_SIDED|95.0|-1.3|1.4|||Mixed model repeated measures|||Instrumental Score, Placebo Vs SB-742457-35mg at Week 12||1.4|-1.3|0.946
72585365|NCT00708552|144701818|SUPERIORITY||Mean Difference (Net)|0.2||||0.802|TWO_SIDED|95.0|-1.3|1.6|||Mixed model repeated measures|||Instrumental Score, Placebo Vs Donepezil at Week 12||1.6|-1.3|0.802
72585366|NCT00708552|144701818|SUPERIORITY||Mean Difference (Net)|-0.4||||0.636|TWO_SIDED|95.0|-2.1|1.3|||Mixed model repeated measures|||Instrumental Score, Placebo Vs SB-742457-15mg at Week 24||1.3|-2.1|0.636
72585367|NCT00708552|144701818|SUPERIORITY||Mean Difference (Net)|-0.3||||0.752|TWO_SIDED|95.0|-2.0|1.5|||Mixed model repeated measures|||Instrumental Score, Placebo Vs SB-742457-35mg at Week 24||1.5|-2.0|0.752
72585368|NCT00708552|144701818|SUPERIORITY||Mean Difference (Net)|-0.1||||0.92|TWO_SIDED|95.0|-1.9|1.7|||Mixed model repeated measures|||Instrumental Score, Placebo Vs Donepezil at Week 24||1.7|-1.9|0.920
72585369|NCT00708552|144701818|SUPERIORITY||Mean Difference (Net)|0.0||||0.972|TWO_SIDED|95.0|-0.7|0.6|||Mixed model repeated measures|||Total Independence Score, Placebo Vs SB-742457-15mg at Week 12||0.6|-0.7|0.972
72585370|NCT00708552|144701818|SUPERIORITY||Mean Difference (Net)|0.3||||0.378|TWO_SIDED|95.0|-0.4|0.9|||Mixed model repeated measures|||Total Independence Score, Placebo Vs SB-742457-35mg at Week 12||0.9|-0.4|0.378
72585371|NCT00708552|144701818|SUPERIORITY||Mean Difference (Net)|0.3||||0.346|TWO_SIDED|95.0|-0.3|0.9|||Mixed model repeated measures|||Total Independence Score, Placebo Vs Donepezil at Week 12||0.9|-0.3|0.346
72585372|NCT00708552|144701818|SUPERIORITY||Mean Difference (Net)|0.1||||0.72|TWO_SIDED|95.0|-0.6|0.9|||Mixed model repeated measures|||Total Independence Score, Placebo Vs SB-742457-15mg at Week 24||0.9|-0.6|0.720
72585373|NCT00708552|144701818|SUPERIORITY||Mean Difference (Net)|0.2||||0.598|TWO_SIDED|95.0|-0.6|1.0|||Mixed model repeated measures|||Total Independence Score, Placebo Vs SB-742457-35mg at Week 24||1.0|-0.6|0.598
72585374|NCT00708552|144701818|SUPERIORITY||Mean Difference (Net)|0.3||||0.48|TWO_SIDED|95.0|-0.5|1.1|||Mixed model repeated measures|||Total Independence Score, Placebo Vs Donepezil at Week 24||1.1|-0.5|0.480
72585375|NCT00375973|144701838|SUPERIORITY_OR_OTHER|||||||0.23|TWO_SIDED||||||Regression, Linear|||||||0.23
72585376|NCT00375973|144701839|SUPERIORITY_OR_OTHER|||||||0.05|TWO_SIDED||||||Regression, Linear|||||||0.05
72585377|NCT00375973|144701840|SUPERIORITY_OR_OTHER|||||||0.67|TWO_SIDED||||||Regression, Linear|||||||0.67
72585378|NCT00375973|144701841|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED||||||Regression, Linear|||||||0.02
72585379|NCT00375973|144701842|SUPERIORITY_OR_OTHER|||||||0.06|TWO_SIDED||||||Regression, Linear|||||||0.06
72585380|NCT00375973|144701843|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED||||||Fisher Exact|||||||0.02
72585381|NCT00375973|144701844|SUPERIORITY_OR_OTHER|||||||0.24|TWO_SIDED||||||Fisher Exact|||||||0.24
72585382|NCT02230904|144701871|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.115|STANDARD_DEVIATION|1.635|||TWO_SIDED|||||||||The change in average adhesiveness score was average score for Treatment B minus average score for Treatment A.||||
72585383|NCT02230904|144701878|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.442|STANDARD_DEVIATION|0.895|||TWO_SIDED|||||||||The change in average adhesiveness score was average score for Treatment B minus average score for Treatment A.||||
72585384|NCT00789373|144701910|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.62||||6e-05|TWO_SIDED|95.0|0.49|0.79|||Log Rank|||900 patients were planned to be enrolled in order to randomize 558 pts to maintenance therapy. This trial was powered for the primary endpoint, PFS (90% power, assuming 238 events with 52% censoring and a PFS Hazard Ratio (HR)=0.65, alpha=0.05). This trial was also powered for a secondary endpoint, OS (93% power, assuming 390 events with 30% censoring and an OS HR=0.70). Alpha was controlled for both a preliminary analysis (alpha=0.0001) and final analysis of OS (alpha=0.0499).||0.79|0.49|0.00006
72585385|NCT00789373|144701911|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.64||||0.0002|TWO_SIDED|95.0|0.51|0.81|||Log Rank|||||0.81|0.51|0.0002
72585386|NCT00789373|144701912|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.78||||0.0195|TWO_SIDED|95.0|0.64|0.96||The predefined alpha for the final analysis of OS is 0.0498 for the unadjusted log-rank test.|Log Rank||Unadjusted HR from Cox model with treatment as the only cofactor.|Type 1 (alpha) error was controlled for the analyses of both PFS and OS in order to maintain an overall two-sided alpha level of 0.05 using a statistical gatekeeping and alpha spending scheme. The unconditional statistical power of the final OS analysis was 93%.||0.96|0.64|0.0195
72585387|NCT01511978|144701920|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||||||<0.0001
72585388|NCT01511978|144701921|SUPERIORITY|||||||0.0001|||||||t-test, 2 sided|||||||0.0001
72585389|NCT03321968|144701924|SUPERIORITY||Adjusted GMT Ratio|1.01|||||TWO_SIDED|95.0|0.87|1.18|||||Adjusted GMT/GMT Ratio based on analysis of covariance (ANCOVA) model with vaccine lot as main effect and the baseline titer (log-transformed) as covariate.|A/H1N1 (California)||1.18|0.87|
72585390|NCT03321968|144701924|SUPERIORITY||Adjusted GMT Ratio|0.96|||||TWO_SIDED|95.0|0.82|1.12|||||Adjusted GMT/GMT Ratio based on ANCOVA model with vaccine lot as main effect and the baseline titer (log-transformed) as covariate.|A/H1N1 (California)||1.12|0.82|
72585391|NCT03321968|144701924|SUPERIORITY||Adjusted GMT Ratio|0.94|||||TWO_SIDED|95.0|0.81|1.1|||||Adjusted GMT/GMT Ratio based on ANCOVA model with vaccine lot as main effect and the baseline titer (log-transformed) as covariate.|A/H1N1 (California)||1.10|0.81|
72585392|NCT03321968|144701924|SUPERIORITY||Adjusted GMT Ratio|0.94|||||TWO_SIDED|95.0|0.77|1.13|||||Adjusted GMT/GMT Ratio based on ANCOVA model with vaccine lot as main effect and the baseline titer (log-transformed) as covariate.|A/H3N2 (Hong Kong)||1.13|0.77|
72585393|NCT03321968|144701924|SUPERIORITY||Adjusted GMT Ratio|1.09|||||TWO_SIDED|95.0|0.91|1.32|||||Adjusted GMT/GMT Ratio based on ANCOVA model with vaccine lot as main effect and the baseline titer (log-transformed) as covariate.|A/H3N2 (Hong Kong)||1.32|0.91|
72585394|NCT03321968|144701924|SUPERIORITY||Adjusted GMT Ratio|1.17|||||TWO_SIDED|95.0|0.97|1.41|||||Adjusted GMT/GMT Ratio based on ANCOVA model with vaccine lot as main effect and the baseline titer (log-transformed) as covariate.|A/H3N2 (Hong Kong)||1.41|0.97|
72585395|NCT03321968|144701924|SUPERIORITY||Adjusted GMT Ratio|1.0|||||TWO_SIDED|95.0|0.87|1.15|||||Adjusted GMT/GMT Ratio based on ANCOVA model with vaccine lot as main effect and the baseline titer (log-transformed) as covariate.|B/Brisbane||1.15|0.87|
72585396|NCT03321968|144701924|SUPERIORITY||Adjusted GMT Ratio|1.09|||||TWO_SIDED|95.0|0.95|1.26|||||Adjusted GMT/GMT Ratio based on ANCOVA model with vaccine lot as main effect and the baseline titer (log-transformed) as covariate.|B/Brisbane||1.26|0.95|
72585397|NCT03321968|144701924|SUPERIORITY||Adjusted GMT Ratio|1.1|||||TWO_SIDED|95.0|0.95|1.26|||||Adjusted GMT/GMT Ratio based on ANCOVA model with vaccine lot as main effect and the baseline titer (log-transformed) as covariate.|B/Brisbane||1.26|0.95|
72585398|NCT03321968|144701924|SUPERIORITY||Adjusted GMT Ratio|0.93|||||TWO_SIDED|95.0|0.8|1.09|||||Adjusted GMT/GMT Ratio based on ANCOVA model with vaccine lot as main effect and the baseline titer (log-transformed) as covariate.|B/Phuket||1.09|0.80|
72585399|NCT03321968|144701924|SUPERIORITY||Adjusted GMT Ratio|0.91|||||TWO_SIDED|95.0|0.78|1.07|||||Adjusted GMT/GMT Ratio based on ANCOVA model with vaccine lot as main effect and the baseline titer (log-transformed) as covariate.|B/Phuket||1.07|0.78|
72585400|NCT03321968|144701924|SUPERIORITY||Adjusted GMT Ratio|0.98|||||TWO_SIDED|95.0|0.84|1.15|||||Adjusted GMT/GMT Ratio based on ANCOVA model with vaccine lot as main effect and the baseline titer (log-transformed) as covariate.|B/Phuket||1.15|0.84|
72585401|NCT00232739|144701964|SUPERIORITY_OR_OTHER||Primary analysis posterior probability|0.9926||||||||||The primary analysis of comparing Sirolimus stent with POBA using Bayesian regression model yields that Sirolimus is superior to POBA in reducing the BAR risk.|Bayesian regression model|Multi-level Bayesian regression model was used in the secondary analysis|Secondary analysis for comparing Sirolimus stent with BMS1 and BMS2 signified that Sirolimus stent is superior to POBA, BMS1 and BMS2 in reducing the BAR risk.|Historical control groups consist of propensity-scored matched cohorts (100 patients each, based on Reference Vessel Diameter, lesion length, diabetes, left anterior artery diseased vessel, and gender) of plain old balloon angioplasty (POBA), first generation (Palmaz-Schatz) bare metal stent (BMS1), and BX VELOCITY bare metal stent (BMS2). Study showed the risk of 6-month in-lesion binary angiographic restenosis (BAR) was much lower for the 2.25 Sirolimus stent compared with POBA, BMS1 or BMS2.||||
72585402|NCT02282813|144701980|SUPERIORITY_OR_OTHER|||||||0.1041|||||||Cochran-Mantel-Haenszel|||||||0.1041
72585403|NCT02282813|144701981|SUPERIORITY_OR_OTHER|||||||0.0503|||||||Cochran-Mantel-Haenszel|||||||.0503
72585404|NCT02282813|144701982|SUPERIORITY_OR_OTHER|||||||0.4817|||||||Cochran-Mantel-Haenszel|||||||0.4817
72585405|NCT02282813|144701983|SUPERIORITY_OR_OTHER|||||||0.8086|||||||Cochran-Mantel-Haenszel|||||||0.8086
72585406|NCT00463047|144701984|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.23|STANDARD_ERROR_OF_MEAN|0.07|<|0.0001||95.0|0.18|0.29|||Mixed effects ANOVA|Crossover analysis||The statistical hypothesis to be tested was:HO: µFBT = µOXY versus Ha: µFBT ≠ µoxy where µFBT and µOXY denote the mean PID15 for double-blind episodes for which patients use FBT and oxycodone (OXY), respectively. The primary variable was analyzed using a mixed effects ANOVA crossover model, with treatment as randomized (FBT or OXY), period, and treatment sequence (as randomized) as fixed factors and patient as a random factor, using compound symmetry for the variance-covariance matrix.||0.29|0.18|<0.0001
72585407|NCT00463047|144701985|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.03|STANDARD_ERROR_OF_MEAN|0.03||0.0081|TWO_SIDED|95.0|0.01|0.05||LS mean, SE of LS mean and p-value for treatment comparison are from ANOVA based on individual episodes with treatment as randomized, phase, and sequence as fixed factors and patient as random factor, using compound symmetry.|ANOVA|||The statistical hypothesis to be tested was: HO: µFBT = µOXY versus Ha: µFBT ≠ µoxy where µFBT and µOXY denote the mean PID5 for double-blind episodes for which patients use FBT and OXY, respectively. The primary variable was analyzed using a mixed effects ANOVA crossover model, with treatment as randomized (FBT or OXY), period, and treatment sequence (as randomized) as fixed factors and patient as a random factor, using compound symmetry for the variance-covariance matrix.||0.05|0.01|0.0081
72585408|NCT00463047|144701986|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.09|STANDARD_ERROR_OF_MEAN|0.04|<|0.0001|TWO_SIDED|95.0|0.05|0.13||LS mean, SE of LS mean and p-value for treatment comparison are from ANOVA based on individual episodes with treatment as randomized, phase, and sequence as fixed factors and patient as random factor, using compound symmetry.|ANOVA|||The statistical hypothesis to be tested was: HO: µFBT = µOXY versus Ha: µFBT ≠ µoxy where µFBT and µOXY denote the mean PID10 for double-blind episodes for which patients use FBT and OXY, respectively. The primary variable was analyzed using a mixed effects ANOVA crossover model, with treatment as randomized (FBT or OXY), period, and treatment sequence (as randomized) as fixed factors and patient as a random factor, using compound symmetry for the variance-covariance matrix.||0.13|0.05|<0.0001
72413686|NCT00144339|144336438|SUPERIORITY_OR_OTHER||Rate Ratio|0.89|STANDARD_ERROR_OF_MEAN|0.03||0.0011||95.0|0.83|0.95|||t-test, 2 sided||Poisson regression adjusting for overdispersion with Pearson's method adjusting for treatment exposure. The logarithm of treatment exposure is used as offset when building the Poisson model.|Poisson regression adjusted for overdispersion and treatment exposure||0.95|0.83|0.0011
72413687|NCT00144339|144336439|SUPERIORITY_OR_OTHER|||||||0.1766||95.0|||||Fisher Exact|||||||0.1766
72413688|NCT00144339|144336440|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.86|STANDARD_ERROR_OF_MEAN|0.04||0.0024||95.0|0.78|0.95|||Log Rank||Hazard ratio shown as tiotropium bromide vs. placebo|Cox regression||0.95|0.78|0.0024
72413689|NCT00144339|144336441|SUPERIORITY_OR_OTHER||Rate ratio|0.94|STANDARD_ERROR_OF_MEAN|0.06||0.3413||95.0|0.82|1.07|||t-test, 2 sided||Ratio of estimated number of events between tiotropium bromide and placebo|||1.07|0.82|0.3413
72413690|NCT00144339|144336442|SUPERIORITY_OR_OTHER||Rate ratio|1.01||||0.8624||95.0|0.87|1.18|||t-test, 2 sided||Ratio of estimated number of days of chronic obstructive pulmonary disease (COPD) exacerbation leading to hospitalization between tio and placebo|Poisson regression adjusting for overdispersion with Pearson's method adjusting for treatment exposure. The logarithm of treatment exposure is used as offset when building the Poisson model.||1.18|0.87|0.8624
72413691|NCT00144339|144336443|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.087|||<|0.0001||95.0|0.077|0.098|||ANOVA|Repeated measures ANOVA||||0.098|0.077|<.0001
72413692|NCT00144339|144336444|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.047|||<|0.0001||95.0|0.037|0.057|||ANOVA|Repeated measures ANOVA||||0.057|0.037|<.0001
72413693|NCT00144339|144336445|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.099|||<|0.0001||95.0|0.087|0.11|||ANOVA|Repeated measures ANOVA||||0.110|0.087|<.0001
72585409|NCT00463047|144701987|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.37|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001||95.0|0.3|0.45||LS mean, SE of LS mean and p-value for treatment comparison are from ANOVA based on individual episodes with treatment as randomized, phase, and sequence as fixed factors and patient as random factor, using compound symmetry.|ANOVA|||The statistical hypothesis to be tested was: HO: µFBT = µOXY versus Ha: µFBT ≠ µoxy where µFBT and µOXY denote the mean PID10 for double-blind episodes for which patients use FBT and OXY, respectively. The primary variable was analyzed using a mixed effects ANOVA crossover model, with treatment as randomized (FBT or OXY), period, and treatment sequence (as randomized) as fixed factors and patient as a random factor, using compound symmetry for the variance-covariance matrix.||0.45|0.30|<0.0001
72585410|NCT00463047|144701988|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.28|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|0.2|0.35||LS mean, SE of LS mean and p-value for treatment comparison are from ANOVA based on individual episodes with treatment as randomized, phase, and sequence as fixed factors and patient as random factor, using compound symmetry.|ANOVA|||The statistical hypothesis to be tested was: HO: µFBT = µOXY versus Ha: µFBT ≠ µoxy where µFBT and µOXY denote the mean PID45 for double-blind episodes for which patients use FBT and OXY, respectively. The primary variable was analyzed using a mixed effects ANOVA crossover model, with treatment as randomized (FBT or OXY), period, and treatment sequence (as randomized) as fixed factors and patient as a random factor, using compound symmetry for the variance-covariance matrix.||0.35|0.20|<0.0001
72585411|NCT00463047|144701989|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.17|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|0.08|0.25||LS mean, SE of LS mean and p-value for treatment comparison are from ANOVA based on individual episodes with treatment as randomized, phase, and sequence as fixed factors and patient as random factor, using compound symmetry.|ANOVA|||The statistical hypothesis to be tested was: HO: µFBT = µOXY versus Ha: µFBT ≠ µoxy where µFBT and µOXY denote the mean PID60 for double-blind episodes for which patients use FBT and OXY, respectively. The primary variable was analyzed using a mixed effects ANOVA crossover model, with treatment as randomized (FBT or OXY), period, and treatment sequence (as randomized) as fixed factors and patient as a random factor, using compound symmetry for the variance-covariance matrix.||0.25|0.08|<0.0001
72585412|NCT00463047|144701996|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.49|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001||95.0|0.39|0.58|||ANOVA|||||0.58|0.39|<0.0001
72413694|NCT00144339|144336446|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.058|||<|0.0001||95.0|0.047|0.069|||ANOVA|Repeated measures ANOVA||||0.069|0.047|<.0001
72413695|NCT00144339|144336447|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.103|||<|0.0001||95.0|0.091|0.115|||ANOVA|Repeated measures ANOVA||||0.115|0.091|<.0001
72413696|NCT00144339|144336448|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.054|||<|0.0001||95.0|0.042|0.065|||ANOVA|Repeated measures ANOVA||||0.065|0.042|<.0001
72413697|NCT00144339|144336449|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.091|||<|0.0001||95.0|0.078|0.104|||ANOVA|Repeated measures ANOVA||||0.104|0.078|<.0001
72413698|NCT00144339|144336450|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.053|||<|0.0001||95.0|0.04|0.066|||ANOVA|Repeated measures ANOVA||||0.066|0.040|<.0001
72413699|NCT00144339|144336451|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.094|||<|0.0001||95.0|0.081|0.107|||ANOVA|Repeated measures ANOVA||||0.107|0.081|<.0001
72413700|NCT00144339|144336452|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.062|||<|0.0001||95.0|0.049|0.075|||ANOVA|Repeated measures ANOVA||||0.075|0.049|<.0001
72413701|NCT00144339|144336453|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.095|||<|0.0001||95.0|0.081|0.109|||ANOVA|Repeated measures ANOVA||||0.109|0.081|<.0001
72413702|NCT00144339|144336454|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.061|||<|0.0001||95.0|0.047|0.075|||ANOVA|Repeated measures ANOVA||||0.075|0.047|<.0001
72413703|NCT00144339|144336455|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.099|||<|0.0001||95.0|0.085|0.114|||ANOVA|Repeated measures ANOVA||||0.114|0.085|<.0001
72413704|NCT00144339|144336456|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.065|||<|0.0001||95.0|0.051|0.08|||ANOVA|Repeated measures ANOVA||||0.080|0.051|<.0001
72413705|NCT00144339|144336457|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.095|||<|0.0001||95.0|0.08|0.11|||ANOVA|Repeated measures ANOVA||||0.110|0.080|<.0001
72413706|NCT00144339|144336458|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.061|||<|0.0001||95.0|0.045|0.076|||ANOVA|Repeated measures ANOVA||||0.076|0.045|<.0001
72413707|NCT00144339|144336459|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.088|||<|0.0001||95.0|0.073|0.103|||ANOVA|Repeated measures ANOVA||||0.103|0.073|<.0001
72413708|NCT00144339|144336460|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.049|||<|0.0001||95.0|0.033|0.065|||ANOVA|Repeated measures ANOVA||||0.065|0.033|<.0001
72585413|NCT00463047|144701997|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.93|STANDARD_ERROR_OF_MEAN|0.34|<|0.0001|TWO_SIDED|95.0|0.7|1.16|||ANOVA|||||1.16|0.70|<0.0001
72585414|NCT00463047|144701998|SUPERIORITY_OR_OTHER|||||||0.1966||95.0|||||Wilcoxon (Mann-Whitney)|P-value for the treatment comparison is from a one-sample Wilcoxon signed rank test.||||||0.1966
72585415|NCT00463047|144701999|SUPERIORITY_OR_OTHER|||||||0.0275||95.0|||||Wilcoxon (Mann-Whitney)|P-value for the treatment comparison is from a one-sample Wilcoxon signed rank test.||||||0.0275
72585416|NCT00463047|144702000|SUPERIORITY_OR_OTHER|||||||0.0001||95.0|||||Wilcoxon (Mann-Whitney)|P-value for the treatment comparison is from a one-sample Wilcoxon signed rank test.||||||0.0001
72585417|NCT00463047|144702001|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon (Mann-Whitney)|P-value for the treatment comparison is from a one-sample Wilcoxon signed rank test.||||||<0.0001
72585418|NCT00463047|144702002|SUPERIORITY_OR_OTHER|||||||0.0004||95.0|||||Wilcoxon (Mann-Whitney)|P-value for the treatment comparison is from a one-sample Wilcoxon signed rank test.||||||0.0004
72585419|NCT00463047|144702003|SUPERIORITY_OR_OTHER|||||||0.0074||95.0|||||Wilcoxon (Mann-Whitney)|P-value for the treatment comparison is from a one-sample Wilcoxon signed rank test.||||||0.0074
72585420|NCT00463047|144702004|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.69|STANDARD_ERROR_OF_MEAN|0.16|<|0.0001||95.0|0.55|0.83||LS mean, SE of LS mean and p-value for treatment comparison are from ANOVA based on individual episodes with treatment as randomized, phase, and sequence as fixed factors and patient as random factor, using compound symmetry.|ANOVA|||||0.83|0.55|<0.0001
72585421|NCT00463047|144702006|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.5054||||0.3022|TWO_SIDED|95.0|0.7|3.3|||Generalized estimating equation|||Analysis is based on a generalized estimating equation model with treatment as a fixed effect and patient as a random effect. A logit link function and compound symmetry working correlation were applied in this model.||3.3|0.7|0.3022
72585422|NCT00463047|144702007|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.4042||||0.0268|TWO_SIDED|95.0|1.0|1.9|||Generalized estimating equation|||Analysis is based on a generalized estimating equation model with treatment as a fixed effect and patient as a random effect. A logit link function and compound symmetry working correlation were applied in this model.||1.9|1.0|0.0268
72585423|NCT00463047|144702008|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.4631||||0.0008|TWO_SIDED|95.0|1.2|1.8|||Generalized estimating equation|||Analysis is based on a generalized estimating equation model with treatment as a fixed effect and patient as a random effect. A logit link function and compound symmetry working correlation were applied in this model.||1.8|1.2|0.0008
72585424|NCT00463047|144702009|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.3184||||0.0084|TWO_SIDED|95.0|1.1|1.6|||Generalized estimating equation|||Analysis is based on a generalized estimating equation model with treatment as a fixed effect and patient as a random effect. A logit link function and compound symmetry working correlation were applied in this model.||1.6|1.1|0.0084
72585425|NCT00463047|144702010|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.0788||||0.5283|TWO_SIDED|95.0|0.9|1.4|||Generalize estimating equation|||Analysis is based on a generalized estimating equation model with treatment as a fixed effect and patient as a random effect. A logit link function and compound symmetry working correlation were applied in this model.||1.4|0.9|0.5283
72585426|NCT00463047|144702011|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.9491||||0.711|TWO_SIDED|95.0|0.7|1.3|||Generalized estimating equation|||Analysis is based on a generalized estimating equation model with treatment as a fixed effect and patient as a random effect. A logit link function and compound symmetry working correlation were applied in this model.||1.3|0.7|0.7110
72585427|NCT00463047|144702012|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.5355||||0.3288|TWO_SIDED|95.0|0.2|1.9|||Generalized estimating equation|||Analysis is based on a generalized estimating equation model with treatment as a fixed effect and patient as a random effect. A logit link function and compound symmetry working correlation were applied in this model.||1.9|0.2|0.3288
72585428|NCT00463047|144702013|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.1485||||0.5145|TWO_SIDED|95.0|0.8|1.7|||Generalized estimating equation|||Analysis is based on a generalized estimating equation model with treatment as a fixed effect and patient as a random effect. A logit link function and compound symmetry working correlation were applied in this model.||1.7|0.8|0.5145
72585429|NCT00463047|144702014|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.4481||||0.0191|TWO_SIDED|95.0|1.1|2.0|||Generalized estimating equation|||Analysis is based on a generalized estimating equation model with treatment as a fixed effect and patient as a random effect. A logit link function and compound symmetry working correlation were applied in this model.||2.0|1.1|0.0191
72585430|NCT00463047|144702015|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.4396||||0.0006|TWO_SIDED|95.0|1.2|1.8|||Generalized estimating equation|||Analysis is based on a generalized estimating equation model with treatment as a fixed effect and patient as a random effect. A logit link function and compound symmetry working correlation were applied in this model.||1.8|1.2|0.0006
72413709|NCT00144339|144336461|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.19|||<|0.0001||95.0|0.168|0.211|||ANOVA|Repeated measures ANOVA||||0.211|0.168|<.0001
72413710|NCT00144339|144336462|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.055|||<|0.0001||95.0|0.037|0.073|||ANOVA|Repeated measures ANOVA||||0.073|0.037|<.0001
72585431|NCT00463047|144702016|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.3426||||0.0044|TWO_SIDED|95.0|1.1|1.6|||Generalized estimating equation|||Analysis is based on a generalized estimating equation model with treatment as a fixed effect and patient as a random effect. A logit link function and compound symmetry working correlation were applied in this model.||1.6|1.1|0.0044
72585432|NCT00463047|144702017|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.1448||||0.2184|TWO_SIDED|95.0|0.9|1.4|||Generalized estimating equation|||Analysis is based on a generalized estimating equation model with treatment as a fixed effect and patient as a random effect. A logit link function and compound symmetry working correlation were applied in this model.||1.4|0.9|0.2184
72585433|NCT00463047|144702018|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.9249||||0.5808|TWO_SIDED|95.0|0.7|1.2|||Generalized estimating equation|||Analysis is based on a generalized estimating equation model with treatment as a fixed effect and patient as a random effect. A logit link function and compound symmetry working correlation were applied in this model.||1.2|0.7|0.5808
72585434|NCT00463047|144702019|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.8908|||<|0.0001|TWO_SIDED|95.0|1.7|2.2|||Generalized estimating equation|||Analysis is based on a generalized estimating equation model with treatment as a fixed effect and patient as a random effect. A cumulative logit link function and independent working correlation were applied in this model. Treatment differences for each time point were measured across all categories of responses.||2.2|1.7|<0.0001
72585435|NCT00463047|144702020|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.5841|||<|0.0001|TWO_SIDED|95.0|1.4|1.8|||Generalized estimating equation|||Analysis is based on a generalized estimating equation model with treatment as a fixed effect and patient as a random effect. A cumulative logit link function and independent working correlation were applied in this model. Treatment differences for each time point were measured across all categories of responses.||1.8|1.4|<0.0001
72585436|NCT02560922|144702046|SUPERIORITY||Mean Difference (Final Values)|-0.63||||0.128|TWO_SIDED|95.0|-1.45|0.18|||Mixed Models Analysis|||Test of between group difference in change from baseline to 3 months||0.18|-1.45|0.128
72585437|NCT02560922|144702046|SUPERIORITY||Mean Difference (Final Values)|-0.84||||0.068|TWO_SIDED|95.0|-1.73|0.06|||Mixed Models Analysis|||Test of between group difference in change from baseline to 9 months||0.06|-1.73|0.068
72585438|NCT02560922|144702047|SUPERIORITY||Mean Difference (Final Values)|-2.62||||0.129|TWO_SIDED|95.0|-6.01|0.77|||Mixed Models Analysis|||Test of between group difference in change from baseline to 3 months||0.77|-6.01|0.129
72585439|NCT02560922|144702047|SUPERIORITY||Mean Difference (Final Values)|-3.31||||0.084|TWO_SIDED|95.0|-7.07|0.44|||Mixed Models Analysis|||Test of between group difference in change from baseline to 9 months||0.44|-7.07|0.084
72585440|NCT02560922|144702048|SUPERIORITY||Mean Difference (Final Values)|-1.61||||0.209|TWO_SIDED|95.0|-4.14|0.91|||Mixed Models Analysis|||Test of between group difference in change from baseline to 3 months||0.91|-4.14|0.209
72585441|NCT02560922|144702048|SUPERIORITY||Mean Difference (Final Values)|-2.2||||0.128|TWO_SIDED|95.0|-5.03|0.63|||Mixed Models Analysis|||Test of between group difference in change from baseline to 9 months||0.63|-5.03|0.128
72585442|NCT02560922|144702049|SUPERIORITY||Mean Difference (Final Values)|-0.83||||0.222|TWO_SIDED|95.0|-2.18|0.51|||Mixed Models Analysis|||Test of between group difference in change from baseline to 3 months||0.51|-2.18|0.222
72585443|NCT02560922|144702049|SUPERIORITY||Mean Difference (Final Values)|-1.14||||0.128|TWO_SIDED|95.0|-2.6|0.33|||Mixed Models Analysis|||Test of between group difference in change from baseline to 9 months||0.33|-2.60|0.128
72585444|NCT02560922|144702050|SUPERIORITY||Mean Difference (Final Values)|1.71||||0.111|TWO_SIDED|95.0|-0.4|3.82|||Mixed Models Analysis|||Test of between group difference in change from baseline to 3 months||3.82|-0.40|0.111
72585445|NCT02560922|144702050|SUPERIORITY||Mean Difference (Final Values)|0.73||||0.502|TWO_SIDED|95.0|-1.42|2.88|||Mixed Models Analysis|||Test of between group difference in change from baseline to 9 months||2.88|-1.42|0.502
72585446|NCT02560922|144702051|SUPERIORITY||Mean Difference (Final Values)|0.76||||0.433|TWO_SIDED|95.0|-1.15|2.66|||Mixed Models Analysis|||Test of between group difference in change from baseline to 3 months||2.66|-1.15|0.433
72585447|NCT02560922|144702051|SUPERIORITY||Mean Difference (Final Values)|1.71||||0.12|TWO_SIDED|95.0|-0.45|3.86|||Mixed Models Analysis|||Test of between group difference in change from baseline to 9 months||3.86|-0.45|0.120
72585448|NCT02560922|144702052|SUPERIORITY||Mean Difference (Final Values)|15.31||||0.001|TWO_SIDED|95.0|9.09|21.53|||Mixed Models Analysis|||Test of between group difference in change from baseline to 3 months||21.53|9.09|0.001
72585449|NCT02560922|144702052|SUPERIORITY||Mean Difference (Final Values)|11.67|||<|0.001|TWO_SIDED|95.0|5.08|18.27|||Mixed Models Analysis|||Test of between group difference in change from baseline to 9 months||18.27|5.08|<0.001
72585450|NCT02560922|144702053|SUPERIORITY||Mean Difference (Final Values)|-0.5||||0.356|TWO_SIDED|95.0|-1.57|0.57|||Mixed Models Analysis|||Test of between group difference in change from baseline to 3 months||0.57|-1.57|0.356
72585451|NCT02560922|144702053|SUPERIORITY||Mean Difference (Final Values)|-1.02||||0.087|TWO_SIDED|95.0|-2.19|0.15|||Mixed Models Analysis|||Test of between group difference in change from baseline to 9 months||0.15|-2.19|0.087
72585452|NCT02560922|144702054|SUPERIORITY||Mean Difference (Final Values)|1.01|||<|0.001|TWO_SIDED|95.0|0.61|1.41|||Mixed Models Analysis|||Test of between group difference in change from baseline to 3 months||1.41|0.61|<0.001
72585453|NCT02560922|144702054|SUPERIORITY||Mean Difference (Final Values)|0.67||||0.002|TWO_SIDED|95.0|0.24|1.09|||Mixed Models Analysis|||Test of between group difference in change from baseline to 9 months||1.09|0.24|0.002
72585454|NCT02560922|144702055|SUPERIORITY||Mean Difference (Final Values)|-1.27|||<|0.001|TWO_SIDED|95.0|-1.6|-0.95|||Mixed Models Analysis|||Test of between-group difference in self-reported change in symptoms (from baseline) at 3 months||-0.95|-1.60|<0.001
72413711|NCT00144339|144336463|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.204|||<|0.0001||95.0|0.18|0.228|||ANOVA|Repeated measures ANOVA||||0.228|0.180|<.0001
72413712|NCT00144339|144336464|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.055|||<|0.0001||95.0|0.034|0.076|||ANOVA|Repeated measures ANOVA||||0.076|0.034|<.0001
72413713|NCT00144339|144336465|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.198|||<|0.0001||95.0|0.173|0.222|||ANOVA|Repeated measures ANOVA||||0.222|0.173|<.0001
72413714|NCT00144339|144336466|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.048|||<|0.0001||95.0|0.026|0.07|||ANOVA|Repeated measures ANOVA||||0.070|0.026|<.0001
72585455|NCT02560922|144702055|SUPERIORITY||Mean Difference (Final Values)|-0.87|||<|0.001|TWO_SIDED|95.0|-1.24|-0.51|||Mixed Models Analysis|||Test of between-group difference in self-reported change in symptoms (from baseline) at 9 months||-0.51|-1.24|<0.001
72413715|NCT00144339|144336467|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.194|||<|0.0001||95.0|0.167|0.221|||ANOVA|Repeated measures ANOVA||||0.221|0.167|<.0001
72585456|NCT03493854|144702056|NON_INFERIORITY|The null hypothesis could be rejected and non-inferiority concluded if the lower bound of the 90% confidence interval of the geometric mean ratio was ≥0.8.|Geometric Mean Ratio|1.22|||||TWO_SIDED|90.0|1.14|1.31|||||The CtroughSC/CtroughIV geometric mean ratio was calculated as the SC dose of pertuzumab (Arm B) relative to the pertuzumab IV dose (Arm A).|The null hypothesis was that the pertuzumab Arm A SC dose is inferior to the pertuzumab Arm B IV dose (i.e., the CtroughSC/CtroughIV geometric mean ratio of the SC dose of pertuzumab relative to the IV dose is not greater than 0.8).||1.31|1.14|
72585457|NCT03493854|144702057|NON_INFERIORITY|The null hypothesis could be rejected and non-inferiority concluded if the lower bound of the 90% confidence interval of the geometric mean ratio was ≥0.8. Non-inferiority was tested in hierarchical order after the primary outcome measure, to adjust for multiple statistical testing and control the type I error at one sided 5% significance level.|Geometric Mean Ratio|1.33|||||TWO_SIDED|90.0|1.24|1.43|||||The CtroughSC/CtroughIV geometric mean ratio was calculated as the SC dose of trastuzumab (Arm B) relative to the trastuzumab IV dose (Arm A).|The null hypothesis was that the trastuzumab Arm B SC dose is inferior to the Arm A trastuzumab IV dose (i.e., the CtroughSC/CtroughIV geometric mean ratio of the SC dose of trastuzumab relative to the IV dose is not greater than 0.8).||1.43|1.24|
72413716|NCT00144339|144336468|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.05|||<|0.0001||95.0|0.026|0.074|||ANOVA|Repeated measures ANOVA||||0.074|0.026|<.0001
72585458|NCT03493854|144702058|OTHER|Descriptive analysis only. tpCR was analyzed outside of a hypothesis-testing framework and according to the methodology outlined in the outcome measure description.|Difference in tpCR Rate|0.15|||||TWO_SIDED|95.0|-8.67|8.97|||||Difference in tpCR rate was calculated as Arm B: PH FDC SC minus Arm A: P+H IV.|||8.97|-8.67|
72585459|NCT03493854|144702059|OTHER|Descriptive analysis only|Hazard Ratio (HR)|1.2||||0.5216|TWO_SIDED|95.0|0.68|2.11|||Log Rank|||||2.11|0.68|0.5216
72585460|NCT03493854|144702060|OTHER|Descriptive analysis only|Hazard Ratio (HR)|1.15||||0.5992|TWO_SIDED|95.0|0.68|1.97|||Log Rank|||||1.97|0.68|0.5992
72585461|NCT03493854|144702061|OTHER|Descriptive analysis only|Hazard Ratio (HR)|1.2||||0.4844|TWO_SIDED|95.0|0.72|1.98|||Log Rank|||||1.98|0.72|0.4844
72585462|NCT03493854|144702062|OTHER|Descriptive analysis only|Hazard Ratio (HR)|1.16||||0.5474|TWO_SIDED|95.0|0.71|1.88|||Log Rank|||||1.88|0.71|0.5474
72585463|NCT03493854|144702063|OTHER|Descriptive analysis only|Hazard Ratio (HR)|1.17||||0.6291|TWO_SIDED|95.0|0.61|2.24|||Log Rank|||||2.24|0.61|0.6291
72585464|NCT03493854|144702064|OTHER|Descriptive analysis only|Hazard Ratio (HR)|1.26||||0.5609|TWO_SIDED|95.0|0.58|2.72|||Log Rank|||||2.72|0.58|0.5609
72585465|NCT02105987|144702090|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin is -10%.|Mean Difference (Net)|-3.4|||||TWO_SIDED|95.0|-9.1|2.4|||Cochran-Mantel-Haenszel||Based on Cochran-Mantel Haenszel stratified analysis adjusting for the following Baseline stratification factor: Original ART third agent class (PI, NNRTI, or INI).|||2.4|-9.1|
72585466|NCT02105987|144702092|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.3|||||TWO_SIDED|95.0|-2.0|1.4|||Cochran-Mantel-Haenszel||Based on Cochran-Mantel Haenszel stratified analysis adjusting for the following Baseline stratification factor: Original ART third agent class (PI, NNRTI, or INI).|||1.4|-2.0|
72585467|NCT02105987|144702097|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.11||||0.096|TWO_SIDED|95.0|-0.02|0.23|||ANCOVA||Statistical analysis of cholesterol is presented|||0.23|-0.02|0.096
72585468|NCT02105987|144702097|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.07||||0.167|TWO_SIDED|95.0|-0.03|0.18|||ANCOVA||Statistical analysis of LDL cholesterol is presented|||0.18|-0.03|0.167
72585469|NCT02105987|144702097|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.02||||0.317|TWO_SIDED|95.0|-0.02|0.06|||ANCOVA||Statistical analysis of HDL cholesterol is presented|||0.06|-0.02|0.317
72413717|NCT00144339|144336469|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.189|||<|0.0001||95.0|0.161|0.216|||ANOVA|Repeated measures ANOVA||||0.216|0.161|<.0001
72413718|NCT00144339|144336470|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.059|||<|0.0001||95.0|0.035|0.084|||ANOVA|Repeated measures ANOVA||||0.084|0.035|<.0001
72413719|NCT00144339|144336471|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.185|||<|0.0001||95.0|0.157|0.213|||ANOVA|Repeated measures ANOVA||||0.213|0.157|<.0001
72413720|NCT00144339|144336472|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.047||||0.0005||95.0|0.021|0.074|||ANOVA|Repeated measures ANOVA||||0.074|0.021|0.0005
72413721|NCT00144339|144336473|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2|||<|0.0001||95.0|0.17|0.229|||ANOVA|Repeated measures ANOVA||||0.229|0.170|<.0001
72413722|NCT00144339|144336474|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.065|||<|0.0001||95.0|0.038|0.093|||ANOVA|Repeated measures ANOVA||||0.093|0.038|<.0001
72413723|NCT00144339|144336475|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.184|||<|0.0001||95.0|0.154|0.215|||ANOVA|Repeated measures ANOVA||||0.215|0.154|<.0001
72585470|NCT02105987|144702097|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.11||||0.187|TWO_SIDED|95.0|-0.05|0.27|||ANCOVA||Statistical analysis of triglycerides is presented|||0.27|-0.05|0.187
72585471|NCT02105987|144702098|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||0.175|TWO_SIDED|95.0|-0.04|0.25|||ANCOVA||Statistical analysis of total cholesterol/HDL cholesterol ratio is presented|||0.25|-0.04|0.175
72585472|NCT02105987|144702099|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.4|||<|0.001|TWO_SIDED|95.0|1.3|3.5|||ANCOVA||Statistical analysis for total score is presented|||3.5|1.3|<0.001
72585473|NCT02105987|144702099|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.0||||0.002|TWO_SIDED|95.0|0.4|1.7|||ANCOVA||Statistical analysis for general satisfaction/clinical subscale score is presented|||1.7|0.4|0.002
72413724|NCT00144339|144336476|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.046||||0.002||95.0|0.017|0.076|||ANOVA|Repeated measures ANOVA||||0.076|0.017|0.0020
72413725|NCT00144339|144336477|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.17|||<|0.0001||95.0|0.139|0.201|||ANOVA|Repeated measures ANOVA||||0.201|0.139|<.0001
72585474|NCT02105987|144702099|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.3|||<|0.001|TWO_SIDED|95.0|0.8|1.8|||ANCOVA||Statistical analysis for lifestyle/ease subscale is presented|||1.8|0.8|<0.001
72585475|NCT02105987|144702100|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.51|||<|0.001|TWO_SIDED|95.0|4.86|8.16|||ANCOVA|||||8.16|4.86|<0.001
72585476|NCT02105987|144702101|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.87|||<|0.001|TWO_SIDED|95.0|-8.64|-5.11|||ANCOVA|||||-5.11|-8.64|<0.001
72585477|NCT02105987|144702102|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.13|||<|0.001|TWO_SIDED|95.0|-0.17|-0.1|||ANCOVA|||||-0.10|-0.17|<0.001
72585478|NCT02105987|144702103|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.375|TWO_SIDED|95.0|-0.31|0.12|||ANCOVA|||||0.12|-0.31|0.375
72585479|NCT02105987|144702104|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.18||||0.749|TWO_SIDED|95.0|-0.93|1.3|||ANCOVA|||||1.30|-0.93|0.749
72585480|NCT02105987|144702105|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.86|||<|0.001|TWO_SIDED|95.0|0.82|0.9||Bone specific alkaline phosphatase|ANCOVA|||||0.90|0.82|<0.001
72585481|NCT02105987|144702105|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.91||||0.002|TWO_SIDED|95.0|0.85|0.96||Osteocalcin|ANCOVA|||||0.96|0.85|0.002
72585482|NCT02105987|144702105|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|-0.09||||0.001|TWO_SIDED|95.0|-0.15|-0.04||Procollagen 1 n-terminal propeptide|ANCOVA|||||-0.04|-0.15|0.001
72585483|NCT02105987|144702105|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.91||||0.001|TWO_SIDED|95.0|0.86|0.96||Type I collagen c-telopeptides|ANCOVA|||||0.96|0.86|0.001
72585484|NCT02105987|144702106|SUPERIORITY_OR_OTHER||Geometric Mean ratio|0.64|||<|0.001|TWO_SIDED|95.0|0.57|0.72||Fatty acid binding protein 2|ANCOVA|||||0.72|0.57|<0.001
72585485|NCT02105987|144702106|SUPERIORITY_OR_OTHER||Geometric Mean ratio|1.08||||0.311|TWO_SIDED|95.0|0.93|1.24||Interleukin 6|ANCOVA|||||1.24|0.93|0.311
72585486|NCT02105987|144702106|SUPERIORITY_OR_OTHER||Geometric Mean ratio|0.92|||<|0.001|TWO_SIDED|95.0|0.89|0.96||Soluble CD14|ANCOVA|||||0.96|0.89|<0.001
72585487|NCT02105987|144702106|SUPERIORITY_OR_OTHER||Geometric Mean ratio|1.01||||0.742|TWO_SIDED|95.0|0.95|1.08||Soluble vasc cell adhesion molecule 1|ANCOVA|||||1.08|0.95|0.742
72585488|NCT02105987|144702107|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.0||||0.999|TWO_SIDED|95.0|0.84|1.19|||ANCOVA|||||1.19|0.84|0.999
72585489|NCT02105987|144702108|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.0||||0.981|TWO_SIDED|95.0|0.91|1.1|||ANCOVA|||||1.10|0.91|0.981
72585490|NCT02105987|144702109|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.97||||0.64|TWO_SIDED|95.0|0.85|1.11|||ANCOVA|||||1.11|0.85|0.640
72585491|NCT02105987|144702110|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.97||||0.645|TWO_SIDED|95.0|0.87|1.09|||ANCOVA|||||1.09|0.87|0.645
72585492|NCT02105987|144702111|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.01||||0.577|TWO_SIDED|95.0|0.97|1.06|||ANCOVA|||||1.06|0.97|0.577
72413726|NCT00144339|144336478|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.032||||0.0365||95.0|0.002|0.061|||ANOVA|Repeated measures ANOVA||||0.061|0.002|0.0365
72413727|NCT00144339|144336479|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.17|||<|0.0001||95.0|0.147|0.192|||ANOVA|Repeated measures ANOVA||||0.192|0.147|<.0001
72413728|NCT00144339|144336480|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.038||||0.0002||95.0|0.018|0.058|||ANOVA|Repeated measures ANOVA||||0.058|0.018|0.0002
72413729|NCT00144339|144336481|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.186|||<|0.0001||95.0|0.161|0.21|||ANOVA|Repeated measures ANOVA||||0.210|0.161|<.0001
72413730|NCT00144339|144336482|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.037||||0.0018||95.0|0.014|0.06|||ANOVA|Repeated measures ANOVA||||0.060|0.014|0.0018
72413731|NCT00144339|144336483|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.176|||<|0.0001||95.0|0.151|0.201|||ANOVA|Repeated measures ANOVA||||0.201|0.151|<.0001
72585493|NCT02105987|144702112|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.01||||0.687|TWO_SIDED|95.0|0.98|1.03|||ANCOVA|||||1.03|0.98|0.687
72585494|NCT02554682|144702119|SUPERIORITY|||||||0.906|||||||Generalized Linear Model|||||||.906
72585495|NCT02554682|144702119|SUPERIORITY|||||||0.796|||||||Generalized Linear Model|||||||.796
72585496|NCT02554682|144702119|SUPERIORITY|||||||0.886|||||||Generalized Linear Model|||||||.886
72585497|NCT02554682|144702119|OTHER|||||||0.082|||||||Generalized Linear Model|||||||.082
72585498|NCT02554682|144702120|SUPERIORITY|||||||0.677|||||||Generalized Linear Model|||||||0.677
72585499|NCT02554682|144702120|SUPERIORITY|||||||0.02|||||||Generalized Linear Model|||||||0.020
72585500|NCT02554682|144702120|SUPERIORITY|||||||0.952|||||||Generalized Linear Model|||||||.952
72585501|NCT02554682|144702120|SUPERIORITY|||||||0.21|||||||Generalized Linear Model|||||||0.210
72585502|NCT02554682|144702121|SUPERIORITY|||||||0.505|||||||Generalized Linear Model|||||||0.505
72585503|NCT02554682|144702121|SUPERIORITY|||||||0.176|||||||Generalized Linear Model|||||||.176
72585504|NCT02554682|144702121|SUPERIORITY|||||||0.134|||||||Generalized Linear Model|||||||0.134
72585505|NCT02554682|144702121|SUPERIORITY|||||||0.029|||||||Generalized Linear Model|||||||0.029
72585506|NCT02554682|144702122|SUPERIORITY|||||||0.037|||||||t-test, 2 sided|||||||.037
72585507|NCT02554682|144702123|SUPERIORITY|||||||0.003|||||||t-test, 2 sided|||||||.003
72585508|NCT02554682|144702124|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<.001
72585509|NCT02554682|144702125|SUPERIORITY|||||||0.571|||||||t-test, 2 sided|||||||.571
72585510|NCT02554682|144702126|SUPERIORITY|||||||0.394|||||||t-test, 2 sided|||||||.394
72585511|NCT02554682|144702127|SUPERIORITY|||||||0.008|||||||t-test, 2 sided|||||||.008
72585512|NCT02554682|144702128|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<.001
72585513|NCT02554682|144702129|SUPERIORITY|||||||0.001|||||||t-test, 2 sided|||||||.001
72585514|NCT02554682|144702130|SUPERIORITY|||||||0.159|||||||t-test, 2 sided|||||||.159
72585515|NCT02554682|144702131|SUPERIORITY|||||||0.112|||||||t-test, 2 sided|||||||.112
72413732|NCT00144339|144336484|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.032||||0.0069||95.0|0.009|0.055|||ANOVA|Repeated measures ANOVA||||0.055|0.009|0.0069
72413733|NCT00144339|144336485|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.154|||<|0.0001||95.0|0.127|0.182|||ANOVA|Repeated measures ANOVA||||0.182|0.127|<.0001
72413734|NCT00144339|144336486|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.04||||0.002||95.0|0.015|0.065|||ANOVA|Repeated measures ANOVA||||0.065|0.015|0.0020
72585516|NCT02554682|144702132|SUPERIORITY|||||||0.165|||||||t-test, 2 sided|||||||.165
72585517|NCT02554682|144702133|SUPERIORITY|||||||0.006|||||||t-test, 2 sided|||||||.006
72585518|NCT01153815|144702137|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Exact Smirnov test|||||||<0.001
72585519|NCT01890122|144702146|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-0.49|STANDARD_ERROR_OF_MEAN|0.107|<|0.0001|TWO_SIDED|95.0|-0.7|-0.278||An analysis of covariance (ANCOVA) model was used with treatment and country as fixed effects, and Baseline HbA1c as a continuous covariate.|ANCOVA|||||-0.278|-0.700|< 0.0001
72585520|NCT01890122|144702146|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-0.68|STANDARD_ERROR_OF_MEAN|0.108|<|0.0001|TWO_SIDED|95.0|-0.889|-0.467||An ANCOVA model was used with treatment and country as fixed effects, and Baseline HbA1c as a continuous covariate.|ANCOVA|||||-0.467|-0.889|< 0.0001
72585521|NCT02907177|144702185|SUPERIORITY||Treatment effect (rate ratio)|1.27||||0.5252|TWO_SIDED|95.0|0.608|2.654|||Negative binomial regression||Rate ratio is ponesimod 20 mg / DMF versus placebo /DMF|||2.654|0.608|0.5252
72585522|NCT02505217|144702191|SUPERIORITY|||||||0.007|||||||Regression, Cox|||||||0.007
72585523|NCT00953654|144702202|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0|||||ANCOVA|The degrees of freedom were adjusted when the sphericity assumption was violated based on Mauchly's test.||Effects of RET and AET were compared to WL using a 3 condition by 3 time ANCOVA. An a priori statistical power analysis showed that a sample of 30 patients would provide a statistical power of .80 to detect a condition-by-time interaction for PSWQ scores assuming a two-tailed alpha value of 0.05, a correlation across repeated measures of 0.75 and a desire to detect a standardized effect size of 0.65.||||<0.05
72413735|NCT00144339|144336487|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.167|||<|0.0001||95.0|0.139|0.194|||ANOVA|Repeated measures ANOVA||||0.194|0.139|<.0001
72413736|NCT00144339|144336488|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.032||||0.0165||95.0|0.006|0.057|||ANOVA|Repeated measures ANOVA||||0.057|0.006|0.0165
72413737|NCT00144339|144336489|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.17|||<|0.0001||95.0|0.141|0.199|||ANOVA|Repeated measures ANOVA||||0.199|0.141|<.0001
72413738|NCT00144339|144336490|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.031||||0.0248||95.0|0.004|0.059|||ANOVA|Repeated measures ANOVA||||0.059|0.004|0.0248
72413739|NCT00144339|144336491|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.166|||<|0.0001||95.0|0.136|0.196|||ANOVA|Repeated measures ANOVA||||0.196|0.136|<.0001
72413740|NCT00144339|144336492|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.05||||0.0004||95.0|0.022|0.078|||ANOVA|Repeated measures ANOVA||||0.078|0.022|0.0004
72413741|NCT00144339|144336493|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.161|||<|0.0001||95.0|0.13|0.192|||ANOVA|Repeated measures ANOVA||||0.192|0.130|<.0001
72413742|NCT00144339|144336494|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.027||||0.0809||95.0|-0.003|0.057|||ANOVA|Repeated measures ANOVA||||0.057|-0.003|0.0809
72413743|NCT00144339|144336495|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.15|||<|0.0001||95.0|0.119|0.182|||ANOVA|Repeated measures ANOVA||||0.182|0.119|<.0001
72413744|NCT00144339|144336496|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.026||||0.0915||95.0|-0.004|0.057|||ANOVA|Repeated measures ANOVA||||0.057|-0.004|0.0915
72413745|NCT00144339|144336497|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.88|||<|0.0001||95.0|-3.535|-2.226|||ANOVA|Repeated measures ANOVA||||-2.226|-3.535|<.0001
72585524|NCT01537042|144702229|SUPERIORITY_OR_OTHER||Treatment Ratio|0.44||||0.0232|TWO_SIDED|95.0|0.22|0.88|||ANCOVA|An analysis of covariance (ANCOVA) was performed for the log-transformed PLMI ratio with treatment and region as factors and Baseline as a covariate.||||0.88|0.22|0.0232
72585525|NCT00457002|144702253|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.87||||0.4364|TWO_SIDED|95.0|0.62|1.23|||Mantel Haenszel|||To conclude superiority of apixaban versus enoxaparin on the primary efficacy endpoint, the upper bound of the two-sided 95.004% confidence interval (CI) for the relative risk (pa/ pe) must be less than 1.||1.23|0.62|0.4364
72413746|NCT00144339|144336498|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.771|||<|0.0001||95.0|-3.461|-2.081|||ANOVA|Repeated measures ANOVA||||-2.081|-3.461|<.0001
72413747|NCT00144339|144336499|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.593|||<|0.0001||95.0|-3.352|-1.834|||ANOVA|Repeated measures ANOVA||||-1.834|-3.352|<.0001
72413748|NCT00144339|144336500|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.384|||<|0.0001||95.0|-3.191|-1.576|||ANOVA|Repeated measures ANOVA||||-1.576|-3.191|<.0001
72413749|NCT00144339|144336501|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.423|||<|0.0001||95.0|-3.277|-1.569|||ANOVA|Repeated measures ANOVA||||-1.569|-3.277|<.0001
72413750|NCT00144339|144336502|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.345|||<|0.0001||95.0|-4.229|-2.462|||ANOVA|Repeated measures ANOVA||||-2.462|-4.229|<.0001
72413751|NCT00144339|144336503|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.818|||<|0.0001||95.0|-3.742|-1.894|||ANOVA|Repeated measures ANOVA||||-1.894|-3.742|<.0001
72413752|NCT00144339|144336504|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.303|||<|0.0001||95.0|-3.266|-1.34|||ANOVA|Repeated measures ANOVA||||-1.340|-3.266|<.0001
72585526|NCT00457002|144702253|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.39|||||TWO_SIDED|95.0|-1.37|0.59||||||||0.59|-1.37|
72585527|NCT00457002|144702254|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.06|||||TWO_SIDED|95.0|0.69|1.63||||||Formal testing of noninferiority for the key secondary efficacy endpoint was not performed since the superiority of the primary efficacy endpoint was not demonstrated.||1.63|0.69|
72585528|NCT00457002|144702254|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.1|||||TWO_SIDED|95.0|-0.61|0.81||||||||0.81|-0.61|
72585529|NCT00457002|144702255|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.09|||||TWO_SIDED|95.0|0.7|1.71||||||||1.71|0.70|
72585530|NCT00457002|144702255|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.14|||||TWO_SIDED|95.0|-0.57|0.85||||||||0.85|-0.57|
72585531|NCT00457002|144702256|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.96|||||TWO_SIDED|95.0|0.78|1.2||||||||1.20|0.78|
72413753|NCT00144339|144336505|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.85|STANDARD_ERROR_OF_MEAN|0.06||0.0242||95.0|0.74|0.98|||Log Rank||Cox regression with treatment; hazard ratio shown as tiotropium bromide vs. placebo|||0.98|0.74|0.0242
72413754|NCT00144339|144336506|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.87|STANDARD_ERROR_OF_MEAN|0.06||0.0339||95.0|0.76|0.99|||Log Rank||Cox regression; cut-off at 4 years ; vital status form intended at 4 years; hazard ratio shown as tio vs. placebo|Hazard ratio of all cause mortality vital status was information followed-up after discontinuation; vital status information up to 1440 days after the start of treatment was used||0.99|0.76|0.0339
72413755|NCT00144339|144336507|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.89|STANDARD_ERROR_OF_MEAN|0.06||0.0859||95.0|0.79|1.02|||Log Rank||Cox regression; cut-off at 4 years plus 30 days; vital status form intended at 4 years; hazard ratio shown as tio vs. placebo|||1.02|0.79|0.0859
72413756|NCT00144339|144336508|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.85||||0.1936||95.0|0.67|1.08|||Log Rank||Cox regression with treatment; hazard ratio shown as tiotropium bromide vs. placebo|||1.08|0.67|0.1936
72413757|NCT00144339|144336509|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.88||||0.2377||95.0|0.71|1.09|||Log Rank||Cox regression; cut-off at 4 years plus 30 days; vital status form intended at 4 years; hazard ratio shown as tiotropium bromide vs. placebo|||1.09|0.71|0.2377
72413758|NCT00144339|144336510|SUPERIORITY_OR_OTHER||Rate ratio of incidence rates|0.84||||0.029||95.0|0.73|0.98|||Z-test|incidence rate = number of patients with event/ time at risk|Rate ratio of incidence rates (tiotropium/placebo)|||0.98|0.73|0.0290
72413759|NCT00144339|144336511|SUPERIORITY_OR_OTHER||Rate ratio of incidence rates|1.44||||0.1158||95.0|0.91|2.26|||Z-test||Rate ratio of incidence rates (tiotropium/placebo)|||2.26|0.91|0.1158
72413760|NCT00144339|144336512|SUPERIORITY_OR_OTHER||Rate ratio of incidence rates|0.95||||0.7725||95.0|0.68|1.33|||Z-test||Rate ratio of incidence rates (tiotropium/placebo)|||1.33|0.68|0.7725
72413761|NCT00144339|144336513|SUPERIORITY_OR_OTHER||Rate ratio of incidence rates|1.25||||0.2666||95.0|0.84|1.87|||Z-test||Rate ratio of incidence rates (tiotropium/placebo)|||1.87|0.84|0.2666
72413762|NCT00144339|144336514|SUPERIORITY_OR_OTHER||Rate ratio of incidence rates|0.59||||0.0337||95.0|0.37|0.96|||Z-test||Rate ratio of incidence rates (tiotropium/placebo)|||0.96|0.37|0.0337
72413763|NCT00144339|144336515|SUPERIORITY_OR_OTHER||Rate ratio of incidence rates|0.58||||0.0537||95.0|0.33|1.01|||Z-test||Rate ratio of incidence rates (tiotropium/placebo)|||1.01|0.33|0.0537
72413764|NCT00144339|144336516|SUPERIORITY_OR_OTHER||Rate ratio of incidence rates|0.71||||0.0403||95.0|0.52|0.99|||Z-test||Rate ratio of incidence rates (tiotropium/placebo)|||0.99|0.52|0.0403
72413765|NCT00144339|144336517|SUPERIORITY_OR_OTHER||Rate ratio of incidence rates|0.84||||0.0001||95.0|0.77|0.92|||Z-test||Rate ratio of incidence rates (tiotropium/placebo)|||0.92|0.77|0.0001
72413766|NCT00144339|144336518|SUPERIORITY_OR_OTHER||Rate ratio of incidence rates|1.2||||0.4789||95.0|0.73|1.98|||Z-test||Rate ratio of incidence rates (tiotropium/placebo)|||1.98|0.73|0.4789
72413767|NCT00144339|144336519|SUPERIORITY_OR_OTHER||Rate ratio of incidence rates|0.84||||0.0014||95.0|0.76|0.94|||Z-test||Rate ratio of incidence rates (tiotropium/placebo)|||0.94|0.76|0.0014
72585532|NCT00457002|144702256|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.24|||||TWO_SIDED|95.0|-1.65|1.17||||||||1.17|-1.65|
72585533|NCT00457002|144702257|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.98|||||TWO_SIDED|95.0|0.79|1.22||||||||1.22|0.79|
72585534|NCT00457002|144702257|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.12|||||TWO_SIDED|95.0|-1.52|1.29||||||||1.29|-1.52|
72585535|NCT00457002|144702258|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.91|||||TWO_SIDED|95.0|0.65|1.29||||||||1.29|0.65|
72585536|NCT00457002|144702258|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.26|||||TWO_SIDED|95.0|-1.23|0.71||||||||0.71|-1.23|
72585537|NCT00457002|144702259|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.68|||||TWO_SIDED|95.0|0.11|4.05||||||||4.05|0.11|
72585538|NCT00457002|144702259|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.03|||||TWO_SIDED|95.0|-0.16|0.1||||||||0.10|-0.16|
72585539|NCT00457002|144702260|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.89|||||TWO_SIDED|95.0|0.68|1.16||||||||1.16|0.68|
72585540|NCT00457002|144702260|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.38|||||TWO_SIDED|95.0|-1.25|0.48||||||||0.48|-1.25|
72585541|NCT00457002|144702261|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.5|||||TWO_SIDED|95.0|0.26|0.96||||||||0.96|0.26|
72585542|NCT00457002|144702261|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.4|||||TWO_SIDED|95.0|-0.78|-0.03||||||||-0.03|-0.78|
72585543|NCT00457002|144702262|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.04|||||TWO_SIDED|95.0|0.84|1.28||||||||1.28|0.84|
72585544|NCT00457002|144702262|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.28|||||TWO_SIDED|95.0|-1.18|1.73||||||||1.73|-1.18|
72413768|NCT00144339|144336520|SUPERIORITY_OR_OTHER||Rate ratio of incidence rates|0.61||||0.0236||95.0|0.4|0.94|||Z-test||Rate ratio of incidence rates (tiotropium/placebo)|||0.94|0.40|0.0236
72585545|NCT00457002|144702263|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.88|||||TWO_SIDED|95.0|0.32|2.43||||||||2.43|0.32|
72585546|NCT00457002|144702263|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.03|||||TWO_SIDED|95.0|-0.26|0.2||||||||0.20|-0.26|
72585547|NCT00457002|144702264|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.88|||||TWO_SIDED|95.0|0.32|2.43||||||||2.43|0.32|
72585548|NCT00457002|144702264|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.03|||||TWO_SIDED|95.0|-0.26|0.2||||||||0.20|-0.26|
72585549|NCT00457002|144702265|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.31|||||TWO_SIDED|95.0|0.11|0.83||||||||0.83|0.11|
72585550|NCT00457002|144702265|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.34|||||TWO_SIDED|95.0|-0.62|-0.07||||||||-0.07|-0.62|
72413769|NCT00144339|144336521|SUPERIORITY_OR_OTHER||Rate ratio of incidence rates|0.95||||0.5064||95.0|0.81|1.11|||Z-test||Rate ratio of incidence rates (tiotropium/placebo)|||1.11|0.81|0.5064
72585551|NCT00457002|144702266|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.94|||||TWO_SIDED|95.0|0.65|1.37||||||||1.37|0.65|
72585552|NCT00457002|144702266|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.14|||||TWO_SIDED|95.0|-1.04|0.76||||||||0.76|-1.04|
72585553|NCT00457002|144702267|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.15|||||TWO_SIDED|95.0|-0.29|-0.02||||||Note: Relative risk was not estimable (0.0); only risk difference could be estimated.||-0.02|-0.29|
72585554|NCT00457002|144702268|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.41|||||TWO_SIDED|95.0|0.14|1.16||||||||1.16|0.14|
72585555|NCT00457002|144702268|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.22|||||TWO_SIDED|95.0|-0.47|0.03||||||||0.03|-0.47|
72585556|NCT00457002|144702269|SUPERIORITY_OR_OTHER||Adjusted Difference of event rates|0.29||||0.0437|TWO_SIDED|95.0|0.01|0.57||The Mantel-Haenszel test stratified by the stratification factors will be used at the one-sided alpha=0.025 level.|Mantel Haenszel|||Adjusted difference of event rates takes the stratification factor into consideration: previous VTE (yes, no) and active or previous cancer (yes, no).||0.57|0.01|0.0437
72585557|NCT00457002|144702270|SUPERIORITY_OR_OTHER||Adjusted Difference of event rates|0.36|||||TWO_SIDED|95.0|-0.33|1.06||||||Adjusted difference of event rates takes the stratification factor into consideration: previous VTE (yes, no) and active or previous cancer (yes, no).||1.06|-0.33|
72585558|NCT00457002|144702271|SUPERIORITY_OR_OTHER||Adjustted difference of event rates|0.59|||||TWO_SIDED|95.0|-16.0|1.33||||||Adjusted difference of event rates takes the stratification factor into consideration: previous VTE (yes, no) and active or previous cancer (yes, no).||1.33|-016|
72585559|NCT00457002|144702272|SUPERIORITY_OR_OTHER||Adjusted Difference of Event Rates|0.87|||||TWO_SIDED|95.0|-0.4|2.14||||||||2.14|-0.40|
72585560|NCT00457002|144702273|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.1|||||TWO_SIDED|95.0|0.74|1.61||||||||1.61|0.74|
72585561|NCT00457002|144702273|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.2|||||TWO_SIDED|95.0|-0.66|1.07||||||||1.07|-0.66|
72585562|NCT00457002|144702282|SUPERIORITY_OR_OTHER||Adjusted Event rate difference|0.0|||||TWO_SIDED|95.0|-0.3|0.29|||||stratification factor: previous VTE (yes, no), and active or previous cancer (yes, no).|Adjusted difference in event rates in MI or stroke.||0.29|-0.30|
72585563|NCT00457002|144702282|SUPERIORITY_OR_OTHER||Adjusted difference of event rates|0.09|||||TWO_SIDED|95.0|-0.11|0.3|||||stratification factor: previous VTE (yes, no), and active or previous cancer (yes, no).|Adjusted difference of event rates for myocardial infarction.||0.30|-0.11|
72585564|NCT00457002|144702282|SUPERIORITY_OR_OTHER||Adjusted difference in event rates|-0.1|||||TWO_SIDED|95.0|-0.32|0.12||||||Adjusted difference in event rates for stroke.||0.12|-0.32|
72585565|NCT00457002|144702282|SUPERIORITY_OR_OTHER||Adjusted difference in event rates|0.09|||||TWO_SIDED|95.0|-0.09|0.28|||||stratification factor: previous VTE (yes, no), and active or previous cancer (yes, no).|Adjusted difference of event rates in thrombocytopenia.||0.28|-0.09|
72585566|NCT04506463|144702318|SUPERIORITY|||||||0.85|||||||Mixed Models Analysis|||||||0.850
72585567|NCT04506463|144702318|SUPERIORITY|||||||0.085|||||||Mixed Models Analysis|||||||0.085
72585568|NCT04506463|144702318|SUPERIORITY|||||||0.85|||||||Mixed Models Analysis|||||||0.850
72585569|NCT04506463|144702319|SUPERIORITY|||||||0.062|||||||Mixed Models Analysis|||||||0.062
72585570|NCT04506463|144702319|SUPERIORITY|||||||0.007|||||||Mixed Models Analysis|||||||0.007
72585571|NCT04506463|144702319|SUPERIORITY|||||||0.936|||||||Mixed Models Analysis|||||||0.936
72413770|NCT00144339|144336522|SUPERIORITY_OR_OTHER||Rate ratio of incidence rates|0.69||||0.0104||95.0|0.52|0.92|||Z-test||Rate ratio of incidence rates (tiotropium/placebo)|||0.92|0.52|0.0104
72413771|NCT00690755|144336527|SUPERIORITY_OR_OTHER|||||||0.001|||||||ANOVA|||||||.001
72413772|NCT04773015|144336534|OTHER|||||||0.6371|||||||Fisher Exact|||||||0.6371
72585572|NCT04506463|144702320|SUPERIORITY|||||||0.042|||||||Mixed Models Analysis|||||||0.042
72585573|NCT04506463|144702320|SUPERIORITY|||||||0.037|||||||Mixed Models Analysis|||||||0.037
72585574|NCT04506463|144702320|SUPERIORITY|||||||0.648|||||||Mixed Models Analysis|||||||0.648
72585575|NCT01085630|144702325|SUPERIORITY|||||||0.2423|||||||Fisher Exact|||||||0.2423
72585576|NCT01017874|144702327|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.85||||0.217|TWO_SIDED|95.0|0.63|1.13|||Wilcoxon (Mann-Whitney)|||||1.13|0.63|0.217
72585577|NCT01017874|144702328|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.94||||0.788|TWO_SIDED|95.0|0.68|1.31|||Wilcoxon (Mann-Whitney)|||||1.31|0.68|0.788
72585578|NCT01017874|144702331|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.85||||0.252|TWO_SIDED|95.0|0.63|1.14|||Wilcoxon (Mann-Whitney)|||||1.14|0.63|0.252
72585579|NCT01017874|144702332|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.84||||0.952|TWO_SIDED|95.0|0.53|1.32|||Wilcoxon (Mann-Whitney)|||||1.32|0.53|0.952
72585580|NCT03809663|144702371|SUPERIORITY||Odds Ratio (OR)|1.686||||0.56|TWO_SIDED|95.0|0.29|9.809||Nominal p-value|Regression, Logistic|||||9.809|0.290|0.56
72585581|NCT03809663|144702371|SUPERIORITY||Odds Ratio (OR)|1.011||||0.99|TWO_SIDED|95.0|0.135|7.551||Nominal p-value|Regression, Logistic|||||7.551|0.135|0.99
72585582|NCT03809663|144702371|SUPERIORITY||Odds Ratio (OR)|2.146||||0.38|TWO_SIDED|95.0|0.39|11.8||Nominal p-value|Regression, Logistic|||||11.800|0.390|0.38
72585583|NCT03809663|144702372|SUPERIORITY||Odds Ratio (OR)|0.982||||0.97|TWO_SIDED|95.0|0.344|2.803||Nominal p-value|Regression, Logistic|||||2.803|0.344|0.97
72585584|NCT03809663|144702372|SUPERIORITY||Odds Ratio (OR)|1.217||||0.7|TWO_SIDED|95.0|0.441|3.356||Nominal p-value|Regression, Logistic|||||3.356|0.441|0.70
72585585|NCT03809663|144702372|SUPERIORITY||Odds Ratio (OR)|0.73||||0.58|TWO_SIDED|95.0|0.243|2.197||Nominal p-value|Regression, Logistic|||||2.197|0.243|0.58
72585586|NCT03020992|144702559|OTHER||Rate ratio|0.18|||<|0.001|TWO_SIDED|95.0|0.116|0.281|||Poisson regression|||"The Poisson regression allowed for a comparison of event rates adjusting for differences in time between prestudy/on-study periods.~Event rates were based on a Poisson model with generalized estimating equations and a log-link, including an offset term for time interval length, and with period and disease duration of axSpA (\<2 years/≥2 years) as covariates. A repeated statement was included for participants and assumed an exchangeable correlation structure between prestudy and on-study flares."||0.281|0.116|<0.001
72585587|NCT01006122|144702591|SUPERIORITY_OR_OTHER||Least Squares (LS) Mean Difference|0.16|STANDARD_ERROR_OF_MEAN|0.747||0.418|TWO_SIDED|80.0|-0.81|1.12|||Mixed Models Analysis|||One sided p-value was based on linear mixed effects model with treatment and period as fixed effects, baseline MWT as a covariate and participant as random effect.||1.12|-0.81|0.418
72585588|NCT01006122|144702592|SUPERIORITY_OR_OTHER||LS Means Difference|-0.73|STANDARD_ERROR_OF_MEAN|0.457||0.054|TWO_SIDED|80.0|-1.32|-0.15|||Mixed Models Analysis|||Day 5 (TP), P-value was based on linear mixed effects model with treatment, period, time and treatment by time interaction as fixed effects, baseline total score as a covariate and participant as random effect.||-0.15|-1.32|0.054
72585589|NCT01006122|144702592|SUPERIORITY_OR_OTHER||LS Means Difference|-0.31|STANDARD_ERROR_OF_MEAN|0.453||0.247|TWO_SIDED|80.0|-0.89|0.27|||Mixed Models Analysis|||Day 10 (TP), P-value was based on linear mixed effects model with treatment, period, time and treatment by time interaction as fixed effects, baseline total score as a covariate and participant as random effect.||0.27|-0.89|0.247
72585590|NCT01006122|144702592|SUPERIORITY_OR_OTHER||LS Means Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.457||0.095|TWO_SIDED|80.0|-1.19|-0.01|||Mixed Models Analysis|||Day 15 (TP), P-value was based on linear mixed effects model with treatment, period, time and treatment by time interaction as fixed effects, baseline total score as a covariate and participant as random effect.||-0.01|-1.19|0.095
72585591|NCT01006122|144702592|SUPERIORITY_OR_OTHER||LS Means Difference|0.13|STANDARD_ERROR_OF_MEAN|0.487||0.604|TWO_SIDED|80.0|-0.5|0.75|||Mixed Models Analysis|||Day 20 (TP), P-value was based on linear mixed effects model with treatment, period, time and treatment by time interaction as fixed effects, baseline total score as a covariate and participant as random effect.||0.75|-0.50|0.604
72585592|NCT01006122|144702592|SUPERIORITY_OR_OTHER||LS Means Difference|-0.35|STANDARD_ERROR_OF_MEAN|0.473||0.232|TWO_SIDED|80.0|-0.95|0.26|||Mixed Models Analysis|||Day 7 (SP), P-value was based on linear mixed effects model with treatment, period, time and treatment by time interaction as fixed effects, baseline total score as a covariate and participant as random effect.||0.26|-0.95|0.232
72413773|NCT04773015|144336535|OTHER|||||||0.1448|||||||Fisher Exact|||||||0.1448
72413774|NCT04773015|144336536|OTHER|||||||0.1507|||||||Fisher Exact|||||||0.1507
72413775|NCT04773015|144336537|OTHER|||||||0.1189|||||||Fisher Exact|||||||0.1189
72413776|NCT00809757|144336562|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.54|||||TWO_SIDED|95.0|-1.412|0.342|||||Difference is Placebo MDI minus Levalbuterol UDV|195 subjects were randomized in order to achieve 150 subjects completing the study. The sample size was set based on FDA requirements, and was outside of statistical considerations.||0.342|-1.412|
72413777|NCT00809757|144336562|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.69|||||TWO_SIDED|95.0|-1.714|0.335|||||Difference is Levalbuterol UDV minus Levalbuterol MDI|195 subjects were randomized in order to achieve 150 subjects completing the study. The sample size was set based on FDA requirements, and was outside of statistical considerations||0.335|-1.714|
72413778|NCT00809757|144336562|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.15|||||TWO_SIDED|95.0|-1.08|0.771|||||Difference is Levalbuterol UDV minus Levalbuterol MDI|195 subjects were randomized in order to achieve 150 subjects completing the study. The sample size was set based on FDA requirements, and was outside of statistical considerations.||0.771|-1.080|
72585593|NCT01006122|144702592|SUPERIORITY_OR_OTHER||LS Means Difference|-0.63|STANDARD_ERROR_OF_MEAN|0.473||0.093|TWO_SIDED|80.0|-1.23|-0.02|||Mixed Models Analysis|||Day 14 (SP), P-value was based on linear mixed effects model with treatment, period, time and treatment by time interaction as fixed effects, baseline total score as a covariate and participant as random effect.||-0.02|-1.23|0.093
72413779|NCT04295564|144336597|SUPERIORITY||Mean Difference (Final Values)|82.1|||<|0.05|TWO_SIDED|95.0|8.3|155.9||This is a calculate p value|Mixed Models Analysis|adjusted for the correlation between twin pairs and gestational age at birth (stratification variable), sex, and length at outpatient testing||||155.9|8.3|<0.05
72413780|NCT04295564|144336598|SUPERIORITY||Mean Difference (Final Values)|0.6|||<|0.02|TWO_SIDED|95.0|0.1|1.1||This is a calculated p value|Mixed Models Analysis|Adjusted for correlation between twin pairs and gestational age at birth (stratification variable), sex, and length at outpatient test.||||1.1|0.1|<0.02
72413781|NCT04295564|144336599|SUPERIORITY||Mean Difference (Final Values)|62.7|||<|0.05|TWO_SIDED|95.0|4.5|121.0||This is a calculated p value|Mixed Models Analysis|P-value adjusted for correlation between twin pairs and gestational age at birth (stratification variable), sex, and length at outpatient testing.||||121|4.5|<0.05
72585594|NCT01006122|144702592|SUPERIORITY_OR_OTHER||LS Means Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.498||0.274|TWO_SIDED|80.0|-0.94|0.34|||Mixed Models Analysis|||Day 21 (SP), P-value was based on linear mixed effects model with treatment, period, time and treatment by time interaction as fixed effects, baseline total score as a covariate and participant as random effect.||0.34|-0.94|0.274
72585595|NCT01006122|144702593|SUPERIORITY_OR_OTHER||LS Means Difference|-0.29|STANDARD_ERROR_OF_MEAN|0.244||0.121|TWO_SIDED|80.0|-0.6|0.03|||Mixed Models Analysis|||Day 5 (TP), P-value was based on linear mixed effects model with treatment, period, time and treatment by time interaction as fixed effects, baseline global score as a covariate and participant as random effect.||0.03|-0.60|0.121
72585596|NCT01006122|144702593|SUPERIORITY_OR_OTHER||LS Means Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.243||0.394|TWO_SIDED|80.0|-0.38|0.25|||Mixed Models Analysis|||Day 10 (TP), P-value was based on linear mixed effects model with treatment, period, time and treatment by time interaction as fixed effects, baseline global score as a covariate and participant as random effect.||0.25|-0.38|0.394
72585597|NCT01006122|144702593|SUPERIORITY_OR_OTHER||LS Means Difference|-0.36|STANDARD_ERROR_OF_MEAN|0.244||0.073|TWO_SIDED|80.0|-0.67|-0.04|||Mixed Models Analysis|||Day 15 (TP), P-value was based on linear mixed effects model with treatment, period, time and treatment by time interaction as fixed effects, baseline global score as a covariate and participant as random effect.||-0.04|-0.67|0.073
72585598|NCT01006122|144702593|SUPERIORITY_OR_OTHER||LS Means Difference|0.0|STANDARD_ERROR_OF_MEAN|0.26||0.495|TWO_SIDED|80.0|-0.34|0.33|||Mixed Models Analysis|||Day 20 (TP), P-value was based on linear mixed effects model with treatment, period, time and treatment by time interaction as fixed effects, baseline global score as a covariate and participant as random effect.||0.33|-0.34|0.495
72585599|NCT01006122|144702593|SUPERIORITY_OR_OTHER||LS Means Difference|0.14|STANDARD_ERROR_OF_MEAN|0.253||0.711|TWO_SIDED|80.0|-0.18|0.46|||Mixed Models Analysis|||Day 7 (SP), P-value was based on linear mixed effects model with treatment, period, time and treatment by time interaction as fixed effects, baseline global score as a covariate and participant as random effect.||0.46|-0.18|0.711
72585600|NCT01006122|144702593|SUPERIORITY_OR_OTHER||LS Means Difference|0.18|STANDARD_ERROR_OF_MEAN|0.253||0.767|TWO_SIDED|80.0|-0.14|0.51|||Mixed Models Analysis|||Day 14 (SP), P-value was based on linear mixed effects model with treatment, period, time and treatment by time interaction as fixed effects, baseline global score as a covariate and participant as random effect.||0.51|-0.14|0.767
72585601|NCT01006122|144702593|SUPERIORITY_OR_OTHER||LS Means Difference|0.14|STANDARD_ERROR_OF_MEAN|0.266||0.698|TWO_SIDED|80.0|-0.2|0.48|||Mixed Models Analysis|||Day 21 (SP), P-value was based on linear mixed effects model with treatment, period, time and treatment by time interaction as fixed effects, baseline global score as a covariate and participant as random effect.||0.48|-0.20|0.698
72585602|NCT01006122|144702596|SUPERIORITY_OR_OTHER||LS Means Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.142||0.127|TWO_SIDED|80.0|-0.34|0.02|||Mixed Models Analysis|||Day 5 (TP), One-sided p-value was based on linear mixed effects model with treatment, period, time and treatment by time interaction as fixed effects and participant as random effect.||0.02|-0.34|0.127
72585603|NCT01006122|144702596|SUPERIORITY_OR_OTHER||LS Means Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.141||0.303|TWO_SIDED|80.0|-0.25|0.11|||Mixed Models Analysis|||Day 10 (TP), One-sided p-value was based on linear mixed effects model with treatment, period, time and treatment by time interaction as fixed effects and participant as random effect.||0.11|-0.25|0.303
72585604|NCT01006122|144702596|SUPERIORITY_OR_OTHER||LS Means Difference|0.09|STANDARD_ERROR_OF_MEAN|0.143||0.738|TWO_SIDED|80.0|-0.09|0.27|||Mixed Models Analysis|||Day 15 (TP), One-sided p-value was based on linear mixed effects model with treatment, period, time and treatment by time interaction as fixed effects and participant as random effect.||0.27|-0.09|0.738
72585605|NCT01006122|144702596|SUPERIORITY_OR_OTHER||LS Means Difference|0.16|STANDARD_ERROR_OF_MEAN|0.152||0.85|TWO_SIDED|80.0|-0.04|0.35|||Mixed Models Analysis|||Day 20 (TP), One-sided p-value was based on linear mixed effects model with treatment, period, time and treatment by time interaction as fixed effects and participant as random effect.||0.35|-0.04|0.850
72585606|NCT01006122|144702596|SUPERIORITY_OR_OTHER||LS Means Difference|0.05|STANDARD_ERROR_OF_MEAN|0.148||0.631|TWO_SIDED|80.0|-0.14|0.24|||Mixed Models Analysis|||Day 7 (SP), One-sided p-value was based on linear mixed effects model with treatment, period, time and treatment by time interaction as fixed effects and participant as random effect.||0.24|-0.14|0.631
72413782|NCT04295564|144336600|SUPERIORITY||Odds Ratio (OR)|0.59|||>|0.05|TWO_SIDED|95.0|0.27|1.31||This is a calculated p value|Regression, Logistic|||||1.31|0.27|>0.05
72413783|NCT04295564|144336600|SUPERIORITY||Odds Ratio (OR)|0.59|||>|0.05|TWO_SIDED|95.0|0.27|1.31|||Regression, Logistic|Adjusted for gestational age at birth (stratification variable)||||1.31|0.27|>0.05
72413784|NCT01928719|144336615|OTHER||Hazard Ratio (HR)|3.3|||<|0.0001|TWO_SIDED|95.0|1.95|5.58|||Regression, Cox||The direction of comparison is reduced nicotine content vs. same nicotine content cigarettes.|||5.58|1.95|<0.0001
72413785|NCT01928719|144336616|OTHER||Hazard Ratio (HR)|3.4|||<|0.0001|TWO_SIDED|95.0|1.99|5.81||Testing the effect of treatment group in a Multivariable Cox Regression Model.|Regression, Cox|Adjusting for Age Group, Working Status, and BMI.|The direction of comparison is reduced nicotine content vs. same nicotine content cigarettes.|The reference group is Same Nicotine Content Group.||5.81|1.99|<0.0001
72413786|NCT01928719|144336616|OTHER||Hazard Ratio (HR)|0.51||||0.06|TWO_SIDED|95.0|0.26|1.03||Testing the effect of age group (ages 30-39) in a Multivariable Cox Regression Model.|Regression, Cox|Adjusting for Treatment Group, Working Status, and BMI.|The direction of comparison is Age group 30-39 to the Age group 18-29.|The reference group is Age equals 18-29.||1.03|0.26|0.06
72413787|NCT01928719|144336616|OTHER||Hazard Ratio (HR)|0.33|||<|0.002|TWO_SIDED|95.0|0.17|0.66||Testing the effect of age group (ages 40-49) in a Multivariable Cox Regression Model.|Regression, Cox|Adjusting for Treatment Group, Working Status, and BMI.|The direction of comparison is Age group 40-49 to the Age group 18-29.|The reference group is Age equals 18-29.||0.66|0.17|<0.002
72413788|NCT01928719|144336616|OTHER||Hazard Ratio (HR)|0.33|||<|0.002|TWO_SIDED|95.0|0.16|0.65||Testing the effect of age group (Ages 50-59) in a Multivariable Cox Regression Model.|Regression, Cox|Adjusting for Treatment Group, Working Status, and BMI.|The direction of comparison is Age group 50-59 to Age group 18-29.|The reference group is Age equals 18-29.||0.65|0.16|<0.002
72413789|NCT01928719|144336616|OTHER||Hazard Ratio (HR)|0.39||||0.1|TWO_SIDED|95.0|0.13|1.18||Testing the effect of age group (Ages 60-65) in a Multivariable Cox Regression Model.|Regression, Cox|Adjusting for Treatment Group, Working Status, and BMI.|The direction of comparison is Age group 60-65 to the Age group 18-29.|The reference group is Age equals 18-29.||1.18|0.13|0.1
72413790|NCT01928719|144336616|OTHER||Hazard Ratio (HR)|1.6||||0.1|TWO_SIDED|95.0|0.92|2.66||Testing the effect of working status in a Multivariable Cox Regression Model.|Regression, Cox|Adjusting for Treatment Group, Age, and BMI.||The reference group is not currently working.|The direction of comparison is currently working to not currently working.|2.66|0.92|0.1
72413791|NCT01928719|144336616|OTHER||Hazard Ratio (HR)|0.25||||0.006|TWO_SIDED|95.0|0.1|0.67||Testing the effect of BMI Normal Weight group (\>=18.5 \& \<25) in a Multivariable Cox Regression Model.|Regression, Cox|Adjusting for Treatment Group, Working Status, and Age.|The direction of comparison is Normal Weight (\>=18.5 \& \<25) to Underweight (\<18.5) group.|The reference group is BMI Underweight (\<18.5)||0.67|0.1|0.006
72413792|NCT01928719|144336616|OTHER||Hazard Ratio (HR)|0.35||||0.034|TWO_SIDED|95.0|0.13|0.92||Testing the effect of BMI Overweight group (\>=25 \& \< 30) in a Multivariable Cox Regression Model.|Regression, Cox|Adjusting for Treatment Group, Working Status, and Age.|The direction of comparison is Overweight (\>=25 \& \< 30) to Underweight (\<18.5) group.|The reference group is BMI Underweight group (\<18.5)||0.92|0.13|0.034
72585607|NCT01006122|144702596|SUPERIORITY_OR_OTHER||LS Means Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.147||0.16|TWO_SIDED|80.0|-0.34|0.04|||Mixed Models Analysis|||Day 14 (SP), One-sided p-value was based on linear mixed effects model with treatment, period, time and treatment by time interaction as fixed effects and participant as random effect.||0.04|-0.34|0.160
72585608|NCT01006122|144702596|SUPERIORITY_OR_OTHER||LS Means Difference|0.02|STANDARD_ERROR_OF_MEAN|0.156||0.541|TWO_SIDED|80.0|-0.18|0.22|||Mixed Models Analysis|||Day 21 (SP), One-sided p-value was based on linear mixed effects model with treatment, period, time and treatment by time interaction as fixed effects and participant as random effect.||0.22|-0.18|0.541
72585609|NCT02268916|144702623|SUPERIORITY|The study was powered based on a two-sample t-test of the primary outcomes, changes in physical activity or social participant over 6 months. Based on previous literature, in order to detect an effect size of 0.28 with at least 70% power, we aimed to recruit at least 35 participants in each treatment group.|Mean Difference (Final Values)|0.39|||=|0.18|TWO_SIDED|95.0|-0.18|0.97|||Mixed Models Analysis|The outcome was adjusted for time of visit, visit x intervention group, age, gender, body mass index, insulin, depression, and time-up-and-go score.||We hypothesized that at the end of 6 months, the intervention group will have increased physical activity as measured by CHAMPS compared to the control group.||0.97|-0.18|=0.18
72413793|NCT01928719|144336616|OTHER||Hazard Ratio (HR)|0.31||||0.011|TWO_SIDED|95.0|0.13|0.77||Testing the effect of BMI Obese group (\>=30) in a Multivariable Cox Regression Model.|Regression, Cox|Adjusting for Treatment Group, Working Status, and Age.|The direction of comparison is Obese (\>=30) to Underweight (\<18.5) group.|The reference group is BMI Underweight group (\<18.5)||0.77|0.13|0.011
72413794|NCT01928719|144336617|OTHER||Least Squares Mean Difference|-4.1||||0.0006|TWO_SIDED|95.0|-6.44|-1.75|||Mixed Models Analysis|The model included time, group, and time-by-group interaction; treating baseline scores for outcomes as covariates|The direction of comparison is reduced nicotine content vs. same nicotine content cigarettes.|||-1.75|-6.44|0.0006
72585610|NCT02268916|144702624|SUPERIORITY||Slope|-2.2||||0.19|TWO_SIDED|95.0|-5.45|1.06|||Mixed Models Analysis|||We hypothesized that at the end of 6 months, intervention group will have improved participation as measured by satisfaction with participation in social roles.||1.06|-5.45|0.19
72585611|NCT02268916|144702624|SUPERIORITY||Slope|-1.02||||0.57|TWO_SIDED|95.0|-4.53|2.48|||Mixed Models Analysis|||We hypothesized that at the end of 6 months, intervention group will have improved participation as measured by satisfaction with participation in discretionary social activities.||2.48|-4.53|0.57
72413795|NCT01928719|144336618|OTHER||Least Squares Mean Difference|-136.7|||<|0.0001|TWO_SIDED|95.0|-171.7|-101.7|||Mixed Models Analysis|The model included time, group, and time-by-group interaction; treating baseline scores for outcomes as covariates|The direction of comparison is reduced nicotine content vs. same nicotine content cigarettes.|||-101.7|-171.7|<.0001
72585612|NCT02268916|144702624|SUPERIORITY||Slope|-2.44||||0.12|TWO_SIDED|95.0|-5.52|0.63|||Mixed Models Analysis|||We hypothesized that at the end of 6 months, intervention group will have improved participation as measured by the survey on the ability to participate in social roles and activities.||0.63|-5.52|0.12
72585613|NCT02268916|144702625|SUPERIORITY||Slope|-1.99|||<|0.05|TWO_SIDED|95.0|-3.97|-0.02|||Mixed Models Analysis|||We hypothesized that at 6-month follow-up, the intervention group will have better performance than the control group in timed up and go test.||-0.02|-3.97|<0.05
72585614|NCT02268916|144702626|SUPERIORITY||Slope|0.11||||0.02|TWO_SIDED|95.0|0.02|0.2|||Mixed Models Analysis|||We hypothesized that at 6-month follow-up, the intervention group will have better performance than the control group in gait speed.||0.20|0.02|0.02
72585615|NCT02268916|144702627|SUPERIORITY||Slope|40.04||||0.02|TWO_SIDED|95.0|7.9|72.17|||Mixed Models Analysis|||We hypothesized that at 6-month follow-up, the intervention group will have better performance than the control group in six-minute walk test.||72.17|7.90|0.02
72585616|NCT03926117|144702630|SUPERIORITY||Median Difference (Final Values)|-66.2|||<|0.0001|TWO_SIDED|95.0|-86.15|-49.12|||Hodges-Lehmann method|||Percent change from baseline is analyzed using nonparametric Hodges-Lehmann estimator. The nonparametric analysis accounts for covariates baseline hemoglobin (greater than or equal to (\>=) 11 or less than (\<) 11 grams per deciliter (g/dL)) and chronic kidney disease stage (3, 4 or 5) by aligning responses within each stratum defined by the covariates prior to analysis.||-49.12|-86.15|<0.0001
72585617|NCT03926117|144702630|SUPERIORITY||Median Difference (Final Values)|-77.71|||<|0.0001|TWO_SIDED|95.0|-94.98|-62.97|||Hodges-Lehmann method|||Percent change from baseline is analyzed using nonparametric Hodges-Lehmann estimator. The nonparametric analysis accounts for covariates baseline hemoglobin (\>= 11 or \< 11 g/dL) and chronic kidney disease stage (3, 4 or 5) by aligning responses within each stratum defined by the covariates prior to analysis.||-62.97|-94.98|<0.0001
72585618|NCT03926117|144702630|SUPERIORITY||Median Difference (Final Values)|-87.76|||<|0.0001|TWO_SIDED|95.0|-101.0|-70.54|||Hodges-Lehmann method|||Percent change from baseline is analyzed using nonparametric Hodges-Lehmann estimator. The nonparametric analysis accounts for covariates baseline hemoglobin (\>= 11 or \< 11 g/dL) and chronic kidney disease stage (3, 4 or 5) by aligning responses within each stratum defined by the covariates prior to analysis.||-70.54|-101.00|<0.0001
72585619|NCT00086138|144702678|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.01||||0.98|TWO_SIDED|95.0|0.52|1.97|||Chi-squared|||The statistical analyses compared data collected from the CGIC of participants who received sertraline who had a score equal to or better than the CGIC of participants who received the placebo intervention.||1.97|0.52|0.98
72585620|NCT00086138|144702679|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.06||||0.11|TWO_SIDED|95.0|0.84|5.04|||Chi-squared|||||5.04|0.84|0.11
72585621|NCT00460811|144702686|SUPERIORITY_OR_OTHER|||||||0.0002|||||||ANCOVA|||For each of the 4 active linaclotide groups, the null hypothesis was that there was no difference between placebo and the dose group in the change from baseline in the weekly normalized CSBM Rate. An observed cases (OC) approach to missing post-baseline data was applied: any missing data were not imputed.||||0.0002
72585622|NCT00460811|144702686|SUPERIORITY_OR_OTHER|||||||0.0036||95.0|||||ANCOVA|||For each of the 4 active linaclotide groups, the null hypothesis was that there was no difference between placebo and the dose group in the change from baseline in the weekly normalized CSBM Rate. An observed cases (OC) approach to missing post-baseline data was applied: any missing data were not imputed.||||0.0036
72585623|NCT00460811|144702686|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||For each of the 4 active linaclotide groups, the null hypothesis was that there was no difference between placebo and the dose group in the change from baseline in the weekly normalized CSBM Rate. An observed cases (OC) approach to missing post-baseline data was applied: any missing data were not imputed.||||<0.0001
72585624|NCT00460811|144702686|SUPERIORITY_OR_OTHER|||||||0.0008||95.0|||||ANCOVA|||For each of the 4 active linaclotide groups, the null hypothesis was that there was no difference between placebo and the dose group in the change from baseline in the weekly normalized CSBM Rate. An observed cases (OC) approach to missing post-baseline data was applied: any missing data were not imputed.||||0.0008
72585625|NCT02748356|144702693|OTHER|1 sample t-test|||||=|0.351|||||||t-test, 2 sided|This is a single group comparison||||||=0.351
72585626|NCT05870371|144702736|OTHER||Mean Difference (Net)|0.37|||=|0.002|TWO_SIDED|||||The above p value corresponds to the Mastoid Process left algometric site. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above value corresponds to the Mastoid Process left algometric site.|Null hypothesis: The application of ATM does not affect the pain sensitivity assessed by the Pain Pressure Threshold (PPT) measured with the pressure algometer (Commander Algometer) in patients with chronic neck pain (main hypothesis).||||=0.002
72585627|NCT05870371|144702736|OTHER||Mean Difference (Net)|0.28|||=|0.018|TWO_SIDED|||||The above p value corresponds to the Mastoid Process right algometric site. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above value corresponds to the Mastoid Process right algometric site.|Null hypothesis: The application of ATM does not affect the pain sensitivity assessed by the Pain Pressure Threshold (PPT) measured with the pressure algometer (Commander Algometer) in patients with chronic neck pain (main hypothesis).||||=0.018
72585628|NCT05870371|144702736|OTHER||Mean Difference (Net)|0.32|||=|0.02|TWO_SIDED|||||The above p value corresponds to the Bladder 10 left (BL 10) algometric site. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above value corresponds to the Bladder 10 left (BL 10) algometric site.|Null hypothesis: The application of ATM does not affect the pain sensitivity assessed by the Pain Pressure Threshold (PPT) measured with the pressure algometer (Commander Algometer) in patients with chronic neck pain (main hypothesis).||||=0.020
72585629|NCT05870371|144702736|OTHER||Mean Difference (Net)|0.39|||=|0.025|TWO_SIDED|||||The above p value corresponds to the Bladder 10 right (BL 10) algometric site. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above value corresponds to the Bladder 10 right (BL 10) algometric site.|Null hypothesis: The application of ATM does not affect the pain sensitivity assessed by the Pain Pressure Threshold (PPT) measured with the pressure algometer (Commander Algometer) in patients with chronic neck pain (main hypothesis).||||=0.025
72585630|NCT05870371|144702736|OTHER||Mean Difference (Net)|0.55|||<|0.001|TWO_SIDED|||||The above p value corresponds to the Zygapophyseal Joint left algometric site. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above value corresponds to the Zygapophyseal Joint left algometric site.|Null hypothesis: The application of ATM does not affect the pain sensitivity assessed by the Pain Pressure Threshold (PPT) measured with the pressure algometer (Commander Algometer) in patients with chronic neck pain (main hypothesis).||||<0.001
72585631|NCT05870371|144702736|OTHER||Mean Difference (Net)|0.57|||<|0.001|TWO_SIDED|||||The above p value corresponds to the Zygapophyseal Joint right algometric site. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above value corresponds to the Zygapophyseal Joint right algometric site.|Null hypothesis: The application of ATM does not affect the pain sensitivity assessed by the Pain Pressure Threshold (PPT) measured with the pressure algometer (Commander Algometer) in patients with chronic neck pain (main hypothesis).||||<0.001
72585632|NCT05870371|144702736|OTHER||Mean Difference (Net)|0.36|||=|0.139|TWO_SIDED|||||The above p value corresponds to the Upper Trapezius Muscle left algometric site. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above value corresponds to the Upper Trapezius Muscle left algometric site.|Null hypothesis: The application of ATM does not affect the pain sensitivity assessed by the Pain Pressure Threshold (PPT) measured with the pressure algometer (Commander Algometer) in patients with chronic neck pain (main hypothesis).||||=0.139
72585633|NCT05870371|144702736|OTHER||Mean Difference (Net)|0.3|||=|0.011|TWO_SIDED|||||The above p value corresponds to the Upper Trapezius Muscle right algometric site. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above value corresponds to the Upper Trapezius Muscle right algometric site.|Null hypothesis: The application of ATM does not affect the pain sensitivity assessed by the Pain Pressure Threshold (PPT) measured with the pressure algometer (Commander Algometer) in patients with chronic neck pain (main hypothesis).||||=0.011
72585634|NCT05870371|144702736|OTHER||Mean Difference (Net)|0.67|||=|0.01|TWO_SIDED|||||The above p value corresponds to the Levator Scapulae Muscle left algometric site. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above value corresponds to the Levator Scapulae Muscle left algometric site.|Null hypothesis: The application of ATM does not affect the pain sensitivity assessed by the Pain Pressure Threshold (PPT) measured with the pressure algometer (Commander Algometer) in patients with chronic neck pain (main hypothesis).||||=0.010
72585635|NCT05870371|144702736|OTHER||Mean Difference (Net)|0.62|||=|0.06|TWO_SIDED|||||The above p value corresponds to the Levator Scapulae Muscle right algometric site. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above value corresponds to the Levator Scapulae Muscle right algometric site.|Null hypothesis: The application of ATM does not affect the pain sensitivity assessed by the Pain Pressure Threshold (PPT) measured with the pressure algometer (Commander Algometer) in patients with chronic neck pain (main hypothesis).||||=0.06
72585636|NCT05870371|144702736|OTHER||Mean Difference (Net)|0.51|||=|0.05|TWO_SIDED|||||The above p value corresponds to the Deltoid Muscle left algometric site. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above value corresponds to the Deltoid Muscle left algometric site.|Null hypothesis: The application of ATM does not affect the pain sensitivity assessed by the Pain Pressure Threshold (PPT) measured with the pressure algometer (Commander Algometer) in patients with chronic neck pain (main hypothesis).||||=0.050
72585637|NCT05870371|144702736|OTHER||Mean Difference (Net)|0.41|||=|0.068|TWO_SIDED|||||The above p value corresponds to the Deltoid Muscle right algometric site. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above value corresponds to the Deltoid Muscle right algometric site.|Null hypothesis: The application of ATM does not affect the pain sensitivity assessed by the Pain Pressure Threshold (PPT) measured with the pressure algometer (Commander Algometer) in patients with chronic neck pain (main hypothesis).||||=0.068
72585638|NCT05870371|144702736|OTHER||Mean Difference (Net)|0.59|||=|0.049|TWO_SIDED|||||The above p value corresponds to the Tibialis Anterior Muscle left algometric site. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above value corresponds to the Tibialis Anterior Muscle left algometric site.|Null hypothesis: The application of ATM does not affect the pain sensitivity assessed by the Pain Pressure Threshold (PPT) measured with the pressure algometer (Commander Algometer) in patients with chronic neck pain (main hypothesis).||||=0.049
72585639|NCT05870371|144702736|OTHER||Mean Difference (Net)|0.73|||=|0.004|TWO_SIDED|||||The above p value corresponds to the Tibialis Anterior Muscle right algometric site. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above value corresponds to the Tibialis Anterior Muscle right algometric site.|Null hypothesis: The application of ATM does not affect the pain sensitivity assessed by the Pain Pressure Threshold (PPT) measured with the pressure algometer (Commander Algometer) in patients with chronic neck pain (main hypothesis).||||=0.004
72585640|NCT05870371|144702736|OTHER||Dependence coefficient (β)|-0.03|STANDARD_ERROR_OF_MEAN|0.03|=|0.297|TWO_SIDED|||||The above p value corresponds to the Mastoid Process left algometric site. The threshold for statistical significance was p \< 0.05. The above value correspond to the comparison which is between groups at baseline.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above values correspond to the Mastoid Process left algometric site. The above values correspond to the comparison which is between groups at baseline.|Null hypothesis: The effect of applying ATM does not differ in reducing the pain sensitivity assessed by the Pain Pressure Threshold (PPT) measured with the pressure algometer (Commander Algometer) in patients with chronic neck pain from applying A-S (main hypothesis).||||=0.297
72585641|NCT05870371|144702736|OTHER||Dependence coefficient (β)|-0.004|STANDARD_ERROR_OF_MEAN|0.03|=|0.855|TWO_SIDED|||||The above p value corresponds to the Mastoid Process right algometric site. The threshold for statistical significance was p \< 0.05. The above value correspond to the comparison which is between groups at baseline.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above values correspond to the Mastoid Process right algometric site. The above values correspond to the comparison which is between groups at baseline.|Null hypothesis: The effect of applying ATM does not differ in reducing the pain sensitivity assessed by the Pain Pressure Threshold (PPT) measured with the pressure algometer (Commander Algometer) in patients with chronic neck pain from applying A-S (main hypothesis).||||=0.855
72585642|NCT05870371|144702736|OTHER||Dependence coefficient (β)|-0.01|STANDARD_ERROR_OF_MEAN|0.02|=|0.594|TWO_SIDED|||||The above p value corresponds to the Bladder 10 (BL 10) left algometric site. The threshold for statistical significance was p \< 0.05. The above value corresponds to the comparison which is between groups at baseline.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above values correspond to the Bladder 10 (BL 10) left algometric site. The above values correspond to the comparison which is between groups at baseline.|Null hypothesis: The effect of applying ATM does not differ in reducing the pain sensitivity assessed by the Pain Pressure Threshold (PPT) measured with the pressure algometer (Commander Algometer) in patients with chronic neck pain from applying A-S (main hypothesis).||||=0.594
72585643|NCT05870371|144702736|OTHER||Dependence coefficient (β)|0.002|STANDARD_ERROR_OF_MEAN|0.02|=|0.929|TWO_SIDED|||||The above p value corresponds to the Bladder 10 (BL 10) right algometric site. The threshold for statistical significance was p \< 0.05. The above value corresponds to the comparison which is between groups at baseline.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above values correspond to the Bladder 10 (BL 10) right algometric site. The above values correspond to the comparison which is between groups at baseline.|Null hypothesis: The effect of applying ATM does not differ in reducing the pain sensitivity assessed by the Pain Pressure Threshold (PPT) measured with the pressure algometer (Commander Algometer) in patients with chronic neck pain from applying A-S (main hypothesis).||||=0.929
72585644|NCT05870371|144702736|OTHER||Dependence coefficient (β)|0.002|STANDARD_ERROR_OF_MEAN|0.05|=|0.725|TWO_SIDED|||||The above p value corresponds to the Zygapophyseal Joint left algometric site. The threshold for statistical significance was p \< 0.05. The above value corresponds to the comparison which is between groups at baseline.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above values correspond to the Zygapophyseal Joint left algometric site. The above values correspond to the comparison which is between groups at baseline.|Null hypothesis: The effect of applying ATM does not differ in reducing the pain sensitivity assessed by the Pain Pressure Threshold (PPT) measured with the pressure algometer (Commander Algometer) in patients with chronic neck pain from applying A-S (main hypothesis).||||=0.725
72585645|NCT05870371|144702736|OTHER||Dependence coefficient (β)|-0.01|STANDARD_ERROR_OF_MEAN|0.02|=|0.725|TWO_SIDED|||||The above p value corresponds to the Zygapophyseal Joint right algometric site. The threshold for statistical significance was p \< 0.05. The above value corresponds to the comparison which is between groups at baseline.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above values correspond to the Zygapophyseal Joint right algometric site. The above values correspond to the comparison which is between groups at baseline.|Null hypothesis: The effect of applying ATM does not differ in reducing the pain sensitivity assessed by the Pain Pressure Threshold (PPT) measured with the pressure algometer (Commander Algometer) in patients with chronic neck pain from applying A-S (main hypothesis).||||=0.725
72585646|NCT05870371|144702736|OTHER||Dependence coefficient (β)|0.02|STANDARD_ERROR_OF_MEAN|0.03|=|0.398|TWO_SIDED|||||The above p value corresponds to the Upper Trapezius Muscle left algometric site. The threshold for statistical significance was p \< 0.05. The above value corresponds to the comparison which is between groups at baseline.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above values correspond to the Upper Trapezius Muscle left algometric site. The above values correspond to the comparison which is between groups at baseline.|Null hypothesis: The effect of applying ATM does not differ in reducing the pain sensitivity assessed by the Pain Pressure Threshold (PPT) measured with the pressure algometer (Commander Algometer) in patients with chronic neck pain from applying A-S (main hypothesis).||||=0.398
72585647|NCT05870371|144702736|OTHER||Dependence coefficient (β)|0.04|STANDARD_ERROR_OF_MEAN|0.03|=|0.186|TWO_SIDED|||||The above p value corresponds to the Mastoid Process right algometric site. The threshold for statistical significance was p \< 0.05. The above value corresponds to the comparison which is between groups at baseline.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above values correspond to the Upper Trapezius Muscle right algometric site. The above values correspond to the comparison which is between groups at baseline.|Null hypothesis: The effect of applying ATM does not differ in reducing the pain sensitivity assessed by the Pain Pressure Threshold (PPT) measured with the pressure algometer (Commander Algometer) in patients with chronic neck pain from applying A-S (main hypothesis).||||=0.186
72585648|NCT05870371|144702736|OTHER||Dependence coefficient (β)|0.01|STANDARD_ERROR_OF_MEAN|0.02|=|0.833|TWO_SIDED|||||The above p value corresponds to the Levator Scapulae Muscle left algometric site. The threshold for statistical significance was p \< 0.05. The above value corresponds to the comparison which is between groups at baseline.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above values correspond to the Levator Scapulae Muscle left algometric site. The above values correspond to the comparison which is between groups at baseline.|Null hypothesis: The effect of applying ATM does not differ in reducing the pain sensitivity assessed by the Pain Pressure Threshold (PPT) measured with the pressure algometer (Commander Algometer) in patients with chronic neck pain from applying A-S (main hypothesis).||||=0.833
72585649|NCT05870371|144702736|OTHER||Dependence coefficient (β)|-0.02|STANDARD_ERROR_OF_MEAN|0.03|=|0.469|TWO_SIDED|||||The above p value corresponds to the Levator Scapulae Muscle right algometric site. The threshold for statistical significance was p \< 0.05. The above value corresponds to the comparison which is between groups at baseline.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above values correspond to the Levator Scapulae Muscle right algometric site. The above values correspond to the comparison which is between groups at baseline.|Null hypothesis: The effect of applying ATM does not differ in reducing the pain sensitivity assessed by the Pain Pressure Threshold (PPT) measured with the pressure algometer (Commander Algometer) in patients with chronic neck pain from applying A-S (main hypothesis).||||=0.469
72585650|NCT05870371|144702736|OTHER||Dependence coefficient (β)|-0.02|STANDARD_ERROR_OF_MEAN|0.03|=|0.399|TWO_SIDED|||||The above p value corresponds to the Deltoid Muscle left algometric site. The threshold for statistical significance was p \< 0.05. The above value corresponds to the comparison which is between groups at baseline.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above values correspond to the Deltoid Muscle left algometric site. The above values correspond to the comparison which is between groups at baseline.|Null hypothesis: The effect of applying ATM does not differ in reducing the pain sensitivity assessed by the Pain Pressure Threshold (PPT) measured with the pressure algometer (Commander Algometer) in patients with chronic neck pain from applying A-S (main hypothesis).||||=0.399
72585651|NCT05870371|144702736|OTHER||Dependence coefficient (β)|-0.01|STANDARD_ERROR_OF_MEAN|0.02|=|0.752|TWO_SIDED|||||The above p value corresponds to the Deltoid Muscle right algometric site. The threshold for statistical significance was p \< 0.05. The above value corresponds to the comparison which is between groups at baseline.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above values correspond to the Deltoid Muscle right algometric site. The above values correspond to the comparison which is between groups at baseline.|Null hypothesis: The effect of applying ATM does not differ in reducing the pain sensitivity assessed by the Pain Pressure Threshold (PPT) measured with the pressure algometer (Commander Algometer) in patients with chronic neck pain from applying A-S (main hypothesis).||||=0.752
72585652|NCT05870371|144702736|OTHER||Dependence coefficient (β)|-0.07|STANDARD_ERROR_OF_MEAN|0.02|=|0.002|TWO_SIDED|||||The above p value corresponds to the Tibialis Anterior Muscle left algometric site. The threshold for statistical significance was p \< 0.05. The above value corresponds to the comparison which is between groups at baseline.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above values correspond to the Tibialis Anterior Muscle left algometric site. The above values correspond to the comparison which is between groups at baseline.|Null hypothesis: The effect of applying ATM does not differ in reducing the pain sensitivity assessed by the Pain Pressure Threshold (PPT) measured with the pressure algometer (Commander Algometer) in patients with chronic neck pain from applying A-S (main hypothesis).||||=0.002
72585653|NCT05870371|144702736|OTHER||Dependence coefficient (β)|-0.07|STANDARD_ERROR_OF_MEAN|0.02|=|0.003|TWO_SIDED|||||The above p value corresponds to the Tibialis Anterior Muscle right algometric site. The threshold for statistical significance was p \< 0.05. The above value corresponds to the comparison which is between groups at baseline.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above values correspond to the Tibialis Anterior Muscle right algometric site. The above values correspond to the comparison which is between groups at baseline.|Null hypothesis: The effect of applying ATM does not differ in reducing the pain sensitivity assessed by the Pain Pressure Threshold (PPT) measured with the pressure algometer (Commander Algometer) in patients with chronic neck pain from applying A-S (main hypothesis).||||=0.003
72585654|NCT05870371|144702737|OTHER||Mean Difference (Net)|5.41|||=|0.002|TWO_SIDED|||||The above p value corresponds to the Rotation maximum. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above value corresponds to the Rotation maximum.|Null hypothesis: The application of ATM does not affect the cervical range of motion (ROM) recorded with the Moover three-dimensional (3D) Inertial Motion sensor in patients with chronic neck pain (secondary hypothesis).||||=0.002
72585655|NCT05870371|144702737|OTHER||Mean Difference (Net)|4.92|||=|0.046|TWO_SIDED|||||The above p value corresponds to the Rotation average. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above value corresponds to the Rotation average.|Null hypothesis: The application of ATM does not affect the cervical range of motion (ROM) recorded with the Moover three-dimensional (3D) Inertial Motion sensor in patients with chronic neck pain (secondary hypothesis).||||=0.046
72585656|NCT05870371|144702737|OTHER||Mean Difference (Net)|3.81|||<|0.001|TWO_SIDED|||||The above p value corresponds to the Lateral Flexion maximum. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above value corresponds to the Lateral Flexion maximum.|Null hypothesis: The application of ATM does not affect the cervical range of motion (ROM) recorded with the Moover three-dimensional (3D) Inertial Motion sensor in patients with chronic neck pain (secondary hypothesis).||||<0.001
72585657|NCT05870371|144702737|OTHER||Mean Difference (Net)|3.57|||=|0.043|TWO_SIDED|||||The above p value corresponds to the Lateral Flexion average. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above value corresponds to the Lateral Flexion average.|Null hypothesis: The application of ATM does not affect the cervical range of motion (ROM) recorded with the Moover three-dimensional (3D) Inertial Motion sensor in patients with chronic neck pain (secondary hypothesis).||||=0.043
72585658|NCT05870371|144702737|OTHER||Mean Difference (Net)|4.52|||=|0.018|TWO_SIDED|||||The above p value corresponds to the Flexion maximum. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above value corresponds to the Flexion maximum.|Null hypothesis: The application of ATM does not affect the cervical range of motion (ROM) recorded with the Moover three-dimensional (3D) Inertial Motion sensor in patients with chronic neck pain (secondary hypothesis).||||=0.018
72585659|NCT05870371|144702737|OTHER||Mean Difference (Net)|4.45|||=|0.102|TWO_SIDED|||||The above p value corresponds to the Flexion average. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above value corresponds to the Flexion average.|Null hypothesis: The application of ATM does not affect the cervical range of motion (ROM) recorded with the Moover three-dimensional (3D) Inertial Motion sensor in patients with chronic neck pain (secondary hypothesis).||||=0.102
72585660|NCT05870371|144702737|OTHER||Mean Difference (Net)|5.85|||=|0.16|TWO_SIDED|||||The above p value corresponds to the Extension maximum. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above value corresponds to the Extension maximum.|Null hypothesis: The application of ATM does not affect the cervical range of motion (ROM) recorded with the Moover three-dimensional (3D) Inertial Motion sensor in patients with chronic neck pain (secondary hypothesis).||||=0.160
72585661|NCT05870371|144702737|OTHER||Mean Difference (Net)|5.48|||<|0.039|TWO_SIDED|||||The above p value corresponds to the Extension average. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above value corresponds to the Extension average.|Null hypothesis: The application of ATM does not affect the cervical range of motion (ROM) recorded with the Moover three-dimensional (3D) Inertial Motion sensor in patients with chronic neck pain (secondary hypothesis).||||<0.039
72585662|NCT05870371|144702737|OTHER||Dependence coefficient (β)|-5.0|STANDARD_ERROR_OF_MEAN|1.51|=|0.001|TWO_SIDED|||||The above p-value corresponds to the Rotation maximum. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above values correspond to the Rotation maximum. The above values correspond to the comparison which is between groups at baseline.|Null hypothesis: The effect of the application of ATM does not differ in the improvement of the cervical ROM recorded with the Moover three-dimensional (3D) Inertial Motion sensor in patients with chronic neck pain from the application of A-S (secondary hypothesis).||||=0.001
72585663|NCT05870371|144702737|OTHER||Dependence coefficient (β)|-5.0|STANDARD_ERROR_OF_MEAN|1.51|=|0.002|TWO_SIDED||||||Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above values correspond to the Rotation average. The above values correspond to the comparison which is between groups at baseline.|Null hypothesis: The effect of the application of ATM does not differ in the improvement of the cervical ROM recorded with the Moover three-dimensional (3D) Inertial Motion sensor in patients with chronic neck pain from the application of A-S (secondary hypothesis).||||=0.002
72585664|NCT05870371|144702737|OTHER||Dependence coefficient (β)|-4.84|STANDARD_ERROR_OF_MEAN|1.6|=|0.048|TWO_SIDED|||||The above p value corresponds to the Lateral Flexion maximum. The threshold for statistical significance was p \< 0.05. The above value corresponds to the comparison which is between groups at baseline.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above values correspond to the Lateral Flexion maximum. The above values correspond to the comparison which is between groups at baseline.|Null hypothesis: The effect of the application of ATM does not differ in the improvement of the cervical ROM recorded with the Moover three-dimensional (3D) Inertial Motion sensor in patients with chronic neck pain from the application of A-S (secondary hypothesis).||||=0.048
72585665|NCT05870371|144702737|OTHER||Dependence coefficient (β)|-2.0|STANDARD_ERROR_OF_MEAN|1.06|=|0.059|TWO_SIDED|||||The above p value corresponds to the Lateral Flexion average. The threshold for statistical significance was p \< 0.05. The above value corresponds to the comparison which is between groups at baseline.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above values correspond to the Lateral Flexion average. The above values correspond to the comparison which is between groups at baseline.|Null hypothesis: The effect of the application of ATM does not differ in the improvement of the cervical ROM recorded with the Moover three-dimensional (3D) Inertial Motion sensor in patients with chronic neck pain from the application of A-S (secondary hypothesis).||||=0.059
72585666|NCT05870371|144702737|OTHER||Dependence coefficient (β)|-0.92|STANDARD_ERROR_OF_MEAN|1.62|=|0.57|TWO_SIDED|||||The above p value corresponds to the Flexion maximum. The threshold for statistical significance was p \< 0.05. The above value corresponds to the comparison which is between groups at baseline.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above values correspond to the Flexion maximum. The above values correspond to the comparison which is between groups at baseline.|Null hypothesis: The effect of the application of ATM does not differ in the improvement of the cervical ROM recorded with the Moover three-dimensional (3D) Inertial Motion sensor in patients with chronic neck pain from the application of A-S (secondary hypothesis).||||=0.57
72585667|NCT05870371|144702737|OTHER||Dependence coefficient (β)|-0.14|STANDARD_ERROR_OF_MEAN|1.65|=|0.931|TWO_SIDED|||||The above p value corresponds to the Flexion average. The threshold for statistical significance was p \< 0.05. The above value corresponds to the comparison which is between groups at baseline.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above values correspond to the Flexion average. The above values correspond to the comparison which is between groups at baseline.|Null hypothesis: The effect of the application of ATM does not differ in the improvement of the cervical ROM recorded with the Moover three-dimensional (3D) Inertial Motion sensor in patients with chronic neck pain from the application of A-S (secondary hypothesis).||||=0.931
72413796|NCT01928719|144336619|OTHER||Least Squares Mean Difference|-4.03||||0.0305|TWO_SIDED|95.0|-7.68|-0.38|||Mixed Models Analysis|The model included time, group, and time-by-group interaction; treating baseline scores for outcomes as covariates|The direction of comparison is reduced nicotine content vs. same nicotine content cigarettes.|||-0.38|-7.68|0.0305
72413797|NCT01928719|144336620|OTHER||Least Squares Mean Difference|1.81||||0.0207|TWO_SIDED|95.0|0.28|3.33|||Mixed Models Analysis|The model included time, group, and time-by-group interaction; treating baseline scores for outcomes as covariates|The direction of comparison is reduced nicotine content vs. same nicotine content cigarettes.|||3.33|0.28|0.0207
72413798|NCT01928719|144336621|OTHER||Least Squares Mean Difference|-0.16||||0.4191|TWO_SIDED|95.0|-0.56|0.23|||Mixed Models Analysis|The model included time, group, and time-by-group interaction; treating baseline scores for outcomes as covariates|The direction of comparison is reduced nicotine content vs. same nicotine content cigarettes.|||0.23|-0.56|0.4191
72413799|NCT02250612|144336622|SUPERIORITY|||||||0.93|||||||ANCOVA|||||||0.93
72585668|NCT05870371|144702737|OTHER||Dependence coefficient (β)|-1.17|STANDARD_ERROR_OF_MEAN|1.99|=|0.558|TWO_SIDED|||||The above p value corresponds to the Extension maximum. The threshold for statistical significance was p \< 0.05. The above value corresponds to the comparison which is between groups at baseline.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above values correspond to the Extension maximum . The above values correspond to the comparison which is between groups at baseline.|Null hypothesis: The effect of the application of ATM does not differ in the improvement of the cervical ROM recorded with the Moover three-dimensional (3D) Inertial Motion sensor in patients with chronic neck pain from the application of A-S (secondary hypothesis).||||=0.558
72585669|NCT05870371|144702737|OTHER||Dependence coefficient (β)|-0.03|STANDARD_ERROR_OF_MEAN|1.96|=|0.989|TWO_SIDED|||||The above p value corresponds to the Extension average. The threshold for statistical significance was p \< 0.05. The above value corresponds to the comparison which is between groups at baseline.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above values correspond to the Extension average. The above values correspond to the comparison which is between groups at baseline.|Null hypothesis: The effect of the application of ATM does not differ in the improvement of the cervical ROM recorded with the Moover three-dimensional (3D) Inertial Motion sensor in patients with chronic neck pain from the application of A-S (secondary hypothesis).||||=0.989
72585670|NCT05870371|144702738|OTHER||Mean Difference (Net)|1.37|||<|0.001|TWO_SIDED|||||The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.||Null hypothesis: The application of ATM does not affect the strength of deep neck flexor muscles as measured by the Chattanooga Stabilizer Pressure Biofeedback in patients with chronic pain in the cervical spine (secondary hypothesis).||||<0.001
72585671|NCT05870371|144702738|OTHER||Dependence coefficient (β)|0.01|STANDARD_ERROR_OF_MEAN|0.01|=|0.437|TWO_SIDED|||||The above value corresponds to the comparison which is between groups at baseline. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above values correspond to the comparison which is between groups at baseline.|Null Hypothesis: The effect of applying ATM does not differ in improving the strength of deep neck flexor muscles measured by the Chattanooga Stabilizer Pressure Biofeedback in patients with chronic neck pain than applying A-S (secondary hypothesis).||||=0.437
72413800|NCT02250612|144336622|SUPERIORITY|||||||0.92|||||||ANCOVA|||||||0.92
72413801|NCT02250612|144336622|SUPERIORITY|||||||0.23|||||||ANCOVA|||||||0.23
72413802|NCT02250612|144336622|SUPERIORITY|||||||0.85|||||||ANCOVA|||||||0.85
72413803|NCT02250612|144336622|SUPERIORITY|||||||0.25|||||||ANCOVA|||||||0.25
72413804|NCT02250612|144336622|SUPERIORITY|||||||0.18|||||||ANCOVA|||||||0.18
72413805|NCT02250612|144336623|SUPERIORITY|||||||0.94|||||||ANCOVA|||||||0.94
72413806|NCT02250612|144336623|SUPERIORITY|||||||0.38|||||||ANCOVA|||||||0.38
72413807|NCT02250612|144336623|SUPERIORITY|||||||0.85|||||||ANCOVA|||||||0.85
72413808|NCT02250612|144336623|SUPERIORITY|||||||0.412|||||||ANCOVA|||||||0.412
72413809|NCT02250612|144336623|SUPERIORITY|||||||0.79|||||||ANCOVA|||||||0.79
72413810|NCT02250612|144336623|SUPERIORITY|||||||0.28|||||||ANCOVA|||||||0.28
72413811|NCT00434057|144336728|SUPERIORITY_OR_OTHER||Sensitivity to melanoma|98.0||||0.05||95.0|95.1|100.0|||exact mid-P||"Of 127 melanomas, 114 melanomas had a pre-biopsy diagnosis of Melanoma can not be ruled out or Not melanoma, which qualified them for primary endpoint analysis of sensitivity. MelaFind correctly identified 112/114 melanomas."|MelaFind's sensitivity to cutaneous melanoma and 95% confidence intervals were determined.||100|95.1|0.05
72413812|NCT00434057|144336728|SUPERIORITY_OR_OTHER|||||||0.02|||||||Chi-squared|||Specificty of MelaFind and examining dermatologists on the same set of pigmented skin lesions.||||0.02
72413813|NCT01306162|144336829|NON_INFERIORITY_OR_EQUIVALENCE|Bioavailability|Geometric mean ratio TrtB: TrtA (%)|214.0|STANDARD_DEVIATION|19.9||1|TWO_SIDED|90.0|191.0|240.0||p-value for geometric mean ratio being outside interval 80% to 125%|ANOVA|ANOVA with sequence, period and treatment as fixed effects and subject within sequence as random effect.|The standard deviation is actually the Geometric coefficient of variation.|150mg DE + 400mg DR same time (TrtB) vs 150mg DE (TrtA)||240|191|1.0000
72585672|NCT05870371|144702739|OTHER||Mean Difference (Net)|0.02|||=|0.919|TWO_SIDED|||||The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.||Null Hypothesis: The application of ATM does not affect the respiratory function assessed by the portable spirometer (MIR Spirodoc) in patients with chronic neck pain (secondary hypothesis).||||=0.919
72585673|NCT05870371|144702739|OTHER||Dependence coefficients (β)|-0.05|STANDARD_ERROR_OF_MEAN|0.02|=|0.01|TWO_SIDED|||||The above value corresponds to the comparison between groups at baseline. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis||The above value corresponds to the comparison between groups at baseline.|Null Hypothesis: The effect of the application of ATM does not differ in the improvement of the respiratory function in patients with chronic neck pain from the application of A-S (secondary hypothesis).||||=0.010
72585674|NCT05870371|144702740|OTHER||Mean Difference (Net)|0.09|||=|0.659|TWO_SIDED|||||The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.||Null Hypothesis: The application of ATM does not affect the respiratory function assessed by the portable spirometer (MIR Spirodoc) in patients with chronic neck pain (secondary hypothesis).||||=0.659
72585675|NCT05870371|144702740|OTHER||Dependence coefficient (β)|-0.04|STANDARD_ERROR_OF_MEAN|0.02|=|0.05|TWO_SIDED|||||The above value correspond to the comparison which is between groups at baseline. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above value correspond to the comparison which is between groups at baseline.|Null Hypothesis: The effect of the application of ATM does not differ in the improvement of the respiratory function in patients with chronic neck pain from the application of A-S (secondary hypothesis).||||=0.05
72585676|NCT05870371|144702741|OTHER||Mean Difference (Net)|10.28|||=|0.09|TWO_SIDED|||||The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.||Null Hypothesis: The application of ATM does not affect the respiratory function assessed by the portable spirometer (MIR Spirodoc) in patients with chronic neck pain (secondary hypothesis).||||=0.09
72585677|NCT05870371|144702741|OTHER||Dependence coefficient (β)|-0.06|STANDARD_ERROR_OF_MEAN|0.02|=|0.005|TWO_SIDED|||||The above value correspond to the comparison which is between groups at baseline. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above value correspond to the comparison which is between groups at baseline.|Null Hypothesis: The effect of the application of ATM does not differ in the improvement of the respiratory function in patients with chronic neck pain from the application of A-S (secondary hypothesis).||||=0.005
72413814|NCT01306162|144336829|NON_INFERIORITY_OR_EQUIVALENCE|Bioavailability|Geometric mean ratio TrtC: TrtA (%)|130.0|STANDARD_DEVIATION|25.0||0.6697|TWO_SIDED|90.0|112.0|151.0||p-value for geometric mean ratio being outside interval 80% to 125%|ANOVA|ANOVA with sequence, period and treatment as fixed effects and subject within sequence as random effect.|The standard deviation is actually the Geometric coefficient of variation|150mg DE + 400mg DR 2h later (TrtC) vs 150mg DE (TrtA)||151|112|0.6697
72413815|NCT01306162|144336829|NON_INFERIORITY_OR_EQUIVALENCE|Bioavailability|Geometric mean ratio TrtD: TrtA (%)|236.0|STANDARD_DEVIATION|21.8||0.9992||90.0|173.0|321.0||p-value for geometric mean ratio being outside interval 80% to 125%|ANOVA|ANOVA with sequence, period and treatment as fixed effects and subject within sequence as random effect.|The standard deviation is actually the Geometric coefficient of variation|150mg DE + 400mg DR bid same time (TrtD) vs 150mg DE (TrtA)||321|173|0.9992
72413816|NCT01306162|144336829|NON_INFERIORITY_OR_EQUIVALENCE|Bioavailability|Geometric mean ratio TrtE: TrtA (%)|162.0|STANDARD_DEVIATION|20.1||0.9171|TWO_SIDED|90.0|119.0|221.0||p-value for geometric mean ratio being outside interval 80% to 125%|ANOVA|ANOVA with sequence, period and treatment as fixed effects and subject within sequence as random effect.|The standard deviation is actually the Geometric coefficient of variation|150mg DE + 400mg DR bid 2h later (TrtE) vs 150mg DE (TrtA)||221|119|0.9171
72585678|NCT05870371|144702742|OTHER||Mean Difference (Net)|-7.87|||<|0.001|TWO_SIDED|||||The above p-value corresponds to the Total McGill Score. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above value corresponds to the Total McGill Score.|Null Hypothesis: The application of ATM does not affect the pain in the cervical spine in terms of its intensity and quality, i.e., its sensory, emotional and behavioral dimensions using the McGill Pain Questionnaire-short form (SFMPQ) in patients with chronic neck pain (secondary hypothesis).||||<0.001
72585679|NCT05870371|144702742|OTHER||Mean Difference (Net)|-5.55|||<|0.001|TWO_SIDED|||||The above p-value corresponds to the Sensory Score. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above value corresponds to the Sensory Score.|Null Hypothesis: The application of ATM does not affect the pain in the cervical spine in terms of its intensity and quality, i.e., its sensory, emotional and behavioral dimensions using the McGill Pain Questionnaire-short form (SFMPQ) in patients with chronic neck pain (secondary hypothesis).||||<0.001
72413817|NCT01306162|144336830|NON_INFERIORITY_OR_EQUIVALENCE|Bioavailability|Geometric mean ratio TrtB: TrtA (%)|187.0|STANDARD_DEVIATION|24.3||0.9999|TWO_SIDED|90.0|162.0|215.0||p-value for geometric mean ratio being outside interval 80% to 125%|ANOVA|ANOVA with sequence, period and treatment as fixed effects and subject within sequence as random effect.|The standard deviation is actually the Geometric coefficient of variation|150mg DE + 400mg DR (TrtB) vs 150mg DE (TrtA)||215|162|0.9999
72413818|NCT01306162|144336830|NON_INFERIORITY_OR_EQUIVALENCE|Bioavailability|Geometric mean ratio TrtC: TrtA (%)|115.0|STANDARD_DEVIATION|31.2||0.2207|TWO_SIDED|90.0|95.0|138.0||p-value for geometric mean ratio being outside interval 80% to 125%|ANOVA|ANOVA with sequence, period and treatment as fixed effects and subject within sequence as random effect.|The standard deviation is actually the Geometric coefficient of variation|150mg DE + 400mg DR 2h later (TrtC) vs 150mg DE (TrtA)||138|95|0.2207
72585680|NCT05870371|144702742|OTHER||Mean Difference (Net)|-2.33|||<|0.001|TWO_SIDED|||||The above p-value corresponds to the Affective Score. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above value corresponds to the Affective Score.|Null Hypothesis: The application of ATM does not affect the pain in the cervical spine in terms of its intensity and quality, i.e., its sensory, emotional and behavioral dimensions using the McGill Pain Questionnaire-short form (SFMPQ) in patients with chronic neck pain (secondary hypothesis).||||<0.001
72585681|NCT05870371|144702742|OTHER||Dependence coefficient (β)|0.0|STANDARD_ERROR_OF_MEAN|0.05|=|0.996|TWO_SIDED|||||The above p-value corresponds to the Total McGill score. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models. The above p-value corresponds to the comparison which is between groups at baseline.|The above values correspond to the comparison which is between groups at baseline.|Null Hypothesis: The effect of the application of ATM does not differ in the reduction of pain in terms of its intensity and quality in patients with chronic neck pain from the application of A-S (secondary hypothesis).||||=0.996
72585682|NCT05870371|144702742|OTHER||Dependence coefficient (β)|0.0|STANDARD_ERROR_OF_MEAN|0.05|=|0.968|TWO_SIDED|||||The above p-value corresponds to the Sensory Score. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models. The above p-value corresponds to the comparison which is between groups at baseline.|The above values correspond to the comparison which is between groups at baseline.|Null Hypothesis: The effect of the application of ATM does not differ in the reduction of pain in terms of its intensity and quality in patients with chronic neck pain from the application of A-S (secondary hypothesis).||||=0.968
72585683|NCT05870371|144702742|OTHER||Dependence coefficient (β)|0.01|STANDARD_ERROR_OF_MEAN|0.05|=|0.854|TWO_SIDED|||||The above p-value corresponds to the Affective Score. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models. The above p-value corresponds to the comparison which is between groups at baseline.|The above values correspond to the comparison which is between groups at baseline.|Null Hypothesis: The effect of the application of ATM does not differ in the reduction of pain in terms of its intensity and quality in patients with chronic neck pain from the application of A-S (secondary hypothesis).||||=0.854
72585684|NCT05870371|144702743|OTHER||Mean Difference (Net)|-2.59|||<|0.001|TWO_SIDED|||||The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.||||||<0.001
72585685|NCT05870371|144702743|OTHER||Dependence coefficient (β)|0.0|STANDARD_ERROR_OF_MEAN|0.03|=|0.952|TWO_SIDED|||||The above value corresponds to the comparison which is between groups at baseline. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above values correspond to the comparison which is between groups at baseline.|||||=0.952
72585686|NCT05870371|144702744|OTHER||Mean Difference (Net)|-1.06|||<|0.001|TWO_SIDED|||||The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|Log transformation was used for the mixed linear models.||||||<0.001
72585687|NCT05870371|144702744|OTHER||Dependence coefficient (β)|0.0|STANDARD_ERROR_OF_MEAN|0.02|=|0.989|TWO_SIDED|||||The above value corresponds to the comparison which is between groups at baseline. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above values correspond to the comparison which is between groups at baseline.|||||=0.989
72585688|NCT05870371|144702745|OTHER||Mean Difference (Net)|-5.6|||<|0.001|TWO_SIDED|||||The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.||Null Hypothesis: The application of ATM does not affect the functionality recorded with the Neck Disability Index (NDI) in patients with chronic pain in the cervical spine (secondary hypothesis).||||<0.001
72585689|NCT05870371|144702745|OTHER||Dependence coefficient (β)|0.0|STANDARD_ERROR_OF_MEAN|0.03|=|0.973|TWO_SIDED|||||The above value corresponds to the comparison which is between groups at baseline. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above value corresponds to the comparison which is between groups at baseline.|Null Hypothesis: The effect of the application of ATM does not differ in the improvement of functionality recorded with the Neck Disability Index (NDI) in patients with chronic neck pain from the application of A-S (secondary hypothesis).||||=0.973
72585690|NCT05870371|144702746|OTHER||Mean Difference (Net)|-2.11|||<|0.001|TWO_SIDED|||||The above p-value corresponds to the Depression subscale of HADS. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|Log transformation was used for the mixed linear models.|The above value corresponds to the Depression subscale of HADS.|Null Hypothesis: The application of ATM does not affect the anxiety and depression captured by the Hospital Anxiety \& Depression Scale (HADS) in patients with chronic neck pain (secondary hypothesis).||||<0.001
72585691|NCT05870371|144702746|OTHER||Mean Difference (Net)|-2.05|||<|0.001|TWO_SIDED|||||The above value corresponds to the Anxiety subscale of HADS. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|Log transformation was used for the mixed linear models.|The above value corresponds to the Anxiety subscale of HADS.|Null Hypothesis: The application of ATM does not affect the anxiety and depression captured by the Hospital Anxiety \& Depression Scale (HADS) in patients with chronic neck pain (secondary hypothesis).||||<0.001
72585692|NCT05870371|144702746|OTHER||Dependence coefficient (β)|0.04|STANDARD_ERROR_OF_MEAN|0.04|=|0.305|TWO_SIDED|||||The above p-value corresponds to the Depression subscale of HADS. The above value corresponds to the comparison which is between groups at baseline. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above values correspond to the Depression subscale of HADS. The above values correspond to the comparison which is between groups at baseline.|Null Hypothesis: The effect of the application of ATM does not differ in the reduction of anxiety and depression captured by the Hospital Anxiety \& Depression Scale (HADS) in patients with chronic pain in the cervical spine from the application of A-S (secondary hypothesis).||||=0.305
72585693|NCT05870371|144702746|OTHER||Dependence coefficient (β)|0.05|STANDARD_ERROR_OF_MEAN|0.03|=|0.137|TWO_SIDED|||||The above p-value corresponds to the Anxiety subscale of HADS. The above value corresponds to the comparison which is between groups at baseline. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|Log transformation was used for the mixed linear models.|The above values correspond to the Anxiety subscale of HADS. The above values correspond to the comparison which is between groups at baseline.|Null Hypothesis: The effect of the application of ATM does not differ in the reduction of anxiety and depression captured by the Hospital Anxiety \& Depression Scale (HADS) in patients with chronic pain in the cervical spine from the application of A-S (secondary hypothesis).||||=0.137
72585694|NCT05870371|144702747|OTHER||Mean Difference (Net)|-3.82|||<|0.001|TWO_SIDED|||||The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.||Null Hypothesis: The application of ATM does not affect the kinesiophobia as measured by the Tampa Scale Kinesiophobia (TSK\_GR) in patients with chronic neck pain (secondary hypothesis).||||<0.001
72585695|NCT05870371|144702747|OTHER||Dependence coefficient (β)|0.02|STANDARD_ERROR_OF_MEAN|0.01|=|0.151|TWO_SIDED|||||The threshold for statistical significance was p \< 0.05. The above value corresponds to the comparison which is between groups at baseline.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above values correspond to the comparison which is between groups at baseline.|Null Hypothesis: The effect of the application of ATM does not differ from the application of A-S in reducing kinesiophobia measured by the Tampa Scale Kinesiophobia (TSK\_GR) in patients with chronic neck pain (secondary hypothesis).||||=0.151
72585696|NCT05870371|144702747|OTHER||||||=|0.021||||||The threshold for statistical significance was p \< 0.05.|McNemar|||||||=0.021
72585697|NCT05870371|144702748|OTHER||Mean Difference (Net)|-4.24|||=|0.006|TWO_SIDED|||||The above p-value corresponds to the FABQ\_physical subscale. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above value corresponds to the FABQ\_physical subscale.|Null Hypothesis: The application of ATM does not affect the perception of the fear and the effort to avoid pain in relation to physical and work activities assessed by the Fear Avoidance Beliefs Questionnaire\_Greek version (FABQ\_GR) in patients with chronic neck pain (secondary hypothesis).||||=0.006
72585698|NCT05870371|144702748|OTHER||Mean Difference (Net)|-2.24|||=|0.001|TWO_SIDED|||||The above p-value corresponds to the FABQ\_work subscale. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above value corresponds to the FABQ\_work subscale.|Null Hypothesis: The application of ATM does not affect the perception of the fear and the effort to avoid pain in relation to physical and work activities assessed by the Fear Avoidance Beliefs Questionnaire\_Greek version (FABQ\_GR) in patients with chronic neck pain (secondary hypothesis).||||=0.001
72585699|NCT05870371|144702748|OTHER||Dependence coefficient (β)|0.1|STANDARD_ERROR_OF_MEAN|0.07|=|0.197|TWO_SIDED|||||The above p-value corresponds to the FABQ\_work subscale. The above value corresponds to the comparison which is between groups at baseline. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above values correspond to the FABQ\_work subscale. The above values correspond to the comparison which is between groups at baseline.|Null Hypothesis: The effect of the application of ATM does not differ in the improvement of perception of fear and effort to avoid pain in relation to physical and work activities assessed by the Fear Avoidance Beliefs Questionnaire\_Greek version (FABQ\_GR) in patients with chronic neck pain from the application of A-S (secondary hypothesis).||||=0.197
72585700|NCT05870371|144702748|OTHER||Dependence coefficient (β)|0.07|STANDARD_ERROR_OF_MEAN|0.04|=|0.066|TWO_SIDED|||||The above p-value corresponds to the FABQ\_physical subscale. The above value corresponds to the comparison which is between groups at baseline. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above values correspond to the FABQ\_physical subscale. The above values correspond to the comparison which is between groups at baseline.|Null Hypothesis: The effect of the application of ATM does not differ in the improvement of perception of fear and effort to avoid pain in relation to physical and work activities assessed by the Fear Avoidance Beliefs Questionnaire\_Greek version (FABQ\_GR) in patients with chronic neck pain from the application of A-S (secondary hypothesis).||||=0.066
72585701|NCT05870371|144702749|OTHER||Mean Difference (Net)|-7.07|||<|0.001|TWO_SIDED|||||The above p-value corresponds to the Total PCS score. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above value corresponds to the Total PCS score.|Null Hypothesis: The application of ATM does not affect the degree of pain catastrophizing recorded by the Pain Catastrophizing Scale (PCS) in patients with chronic neck pain (secondary hypothesis).||||<0.001
72585702|NCT05870371|144702749|OTHER||Mean Difference (Net)|-2.02|||<|0.001|TWO_SIDED|||||The above p-value corresponds to the Rumination subscale of PCS. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above value corresponds to the Rumination subscale of PCS.|Null Hypothesis: The application of ATM does not affect the degree of pain catastrophizing recorded by the Pain Catastrophizing Scale (PCS) in patients with chronic neck pain (secondary hypothesis).||||<0.001
72585703|NCT05870371|144702749|OTHER||Mean Difference (Net)|-1.66|||<|0.001|TWO_SIDED|||||The above p-value corresponds to the Magnification subscale of PCS. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above value corresponds to the Magnification subscale of PCS.|Null Hypothesis: The application of ATM does not affect the degree of pain catastrophizing recorded by the Pain Catastrophizing Scale (PCS) in patients with chronic neck pain (secondary hypothesis).||||<0.001
72585704|NCT05870371|144702749|OTHER||Mean Difference (Net)|-3.39|||<|0.001|TWO_SIDED|||||The above p-value corresponds to the Helplessness subscale of PCS. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above value corresponds to the Helplessness subscale of PCS.|Null Hypothesis: The application of ATM does not affect the degree of pain catastrophizing recorded by the Pain Catastrophizing Scale (PCS) in patients with chronic neck pain (secondary hypothesis).||||<0.001
72585705|NCT05870371|144702749|OTHER||Dependence coefficient (β)|0.01|STANDARD_ERROR_OF_MEAN|0.05|=|0.871|TWO_SIDED|||||The above p-value corresponds to the Total PCS score. The above value corresponds to the comparison which is between groups at baseline. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above values correspond to the Total PCS score. The above values correspond to the comparison which is between groups at baseline.|Null Hypothesis: The effect of the application of ATM does not differ from the application of A-S in reducing pain catastrophizing recorded by the Pain Catastrophizing Scale (PCS) in patients with chronic neck pain (secondary hypothesis).|The above values correspond to the comparison which is between groups at baseline.|||=0.871
72585706|NCT05870371|144702749|OTHER||Dependence coefficient (β)|-0.01|STANDARD_ERROR_OF_MEAN|0.06|=|0.887|TWO_SIDED|||||The above p-value corresponds to the Rumination subscale of PCS. The above value correspond to the comparison which is between groups at baseline. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above values correspond to the Rumination subscale of PCS. The above values correspond to the comparison which is between groups at baseline.|Null Hypothesis: The effect of the application of ATM does not differ from the application of A-S in reducing pain catastrophizing recorded by the Pain Catastrophizing Scale (PCS) in patients with chronic neck pain (secondary hypothesis).||||=0.887
72585707|NCT05870371|144702749|OTHER||Dependence coefficient (β)|0.01|STANDARD_ERROR_OF_MEAN|0.05|=|0.879|TWO_SIDED|||||The above p-value corresponds to the Magnification subscale of PCS. The above value corresponds to the comparison which is between groups at baseline. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above values correspond to the Magnification subscale of PCS. The above values correspond to the comparison which is between groups at baseline.|Null Hypothesis: The effect of the application of ATM does not differ from the application of A-S in reducing pain catastrophizing recorded by the Pain Catastrophizing Scale (PCS) in patients with chronic neck pain (secondary hypothesis).||||=0.879
72585708|NCT05870371|144702749|OTHER||Dependence coefficient (β)|0.0|STANDARD_ERROR_OF_MEAN|0.05|=|0.961|TWO_SIDED|||||The above p-value corresponds to the Helplessness subscale of PCS. The above value corresponds to the comparison which is between groups at baseline. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above values correspond to the Helplessness subscale of PCS. The above values correspond to the comparison which is between groups at baseline.|Null Hypothesis: The effect of the application of ATM does not differ from the application of A-S in reducing pain catastrophizing recorded by the Pain Catastrophizing Scale (PCS) in patients with chronic neck pain (secondary hypothesis).||||=0.961
72585709|NCT05870371|144702750|OTHER||Mean Difference (Net)|4.99|||<|0.001|TWO_SIDED|||||The above p-value corresponds to the Physical Component Summary/PCS subscale of SF-12. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above value corresponds to the Physical Component Summary/PCS subscale of SF-12.|Null Hypothesis: The application of ATM does not affect the quality of life as measured by the Short Form 12-item Health Survey (SF-12) in patients with chronic neck pain (secondary hypothesis).||||<0.001
72585710|NCT05870371|144702750|OTHER||Mean Difference (Net)|8.33|||<|0.001|TWO_SIDED|||||The above p-value corresponds to the Mental Component Summary/MCS subscale of SF-12. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above value corresponds to the Mental Component Summary/MCS subscale of SF-12.|Null Hypothesis: The application of ATM does not affect the quality of life as measured by the Short Form 12-item Health Survey (SF-12) in patients with chronic neck pain (secondary hypothesis).||||<0.001
72585711|NCT05870371|144702750|OTHER||Dependence coefficient (β)|-0.76|STANDARD_ERROR_OF_MEAN|1.32|=|0.564|TWO_SIDED|||||The above p-value corresponds to the Physical Component Summary/PCS of SF-12. The above p-value corresponds to the comparison which is between groups at baseline. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above values correspond to the Physical Component Summary/PCS subscale of SF-12. The above values correspond to the comparison which is between groups at baseline.|Null Hypothesis: The effect of the application of ATM does not differ in the improvement of quality of life measured by the Short Form 12-item Health Survey (SF-12) in patients with chronic pain in the cervical spine from the application of A-S (secondary hypothesis).||||=0.564
72585712|NCT05870371|144702750|OTHER||Dependence coefficient (β)|-3.05|STANDARD_ERROR_OF_MEAN|1.34|=|0.023|TWO_SIDED|||||The above p-value corresponds to Mental Component Summary/MCS of SF-12. The above p-value corresponds to the comparison which is between groups at baseline.The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above values correspond to the Mental Component Summary/MCS of SF-12. The above values correspond to the comparison which is between groups at baseline.|Null Hypothesis: The effect of the application of ATM does not differ in the improvement of quality of life measured by the Short Form 12-item Health Survey (SF-12) in patients with chronic pain in the cervical spine from the application of A-S (secondary hypothesis).||||=0.023
72585713|NCT05870371|144702751|OTHER||||||=|0.014||||||The threshold for statistical significance was p \< 0.05.|Wilcoxon (Mann-Whitney)|||||||=0.014
72585714|NCT05870371|144702751|OTHER||Median Difference (Net)|1.0|||||TWO_SIDED|||||||||||||
72585715|NCT05870371|144702751|OTHER||Median Difference (Net)|2.0|||||TWO_SIDED|||||||||||||
72585716|NCT00708461|144702762|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.125|STANDARD_ERROR_OF_MEAN|0.1202||0.36|TWO_SIDED|95.0|-0.21|0.46||Adjusted for age, educational attainment, race/ethnicity, and smoking status as individual, fixed-effect covariates. 95% confidence intervals and p-values derived from t-statistics with 4 degrees of freedom, reflecting the group-randomized design.|ANCOVA|Adjusted for age, educational attainment, race/ethnicity, and smoking status as individual, fixed-effect covariates.||"The null hypothesis was no effect of the environmental intervention. The following power assumptions were made:~* Intraclass correlation (ICC) of 0.016, estimated from an earlier study~* Variance of 118 kg, estimated from an earlier study~* Cohort N=400~* 15% attrition (by turnover) Using the external control and a worksite correlation of 0.2 gives a detectable difference of about 1.5 kg or 3 lb, or an effect size of 0.14. The effect size using internal control is 0.20."||0.46|-0.21|0.36
72585717|NCT03517540|144702779|SUPERIORITY||Odds Ratio (OR)|0.8||||0.688|TWO_SIDED|95.0|0.25|2.63|||Cochran-Mantel-Haenszel|||||2.63|0.25|0.688
72585718|NCT03517540|144702779|SUPERIORITY||Odds Ratio (OR)|1.01||||0.985|TWO_SIDED|95.0|0.51|1.99|||Cochran-Mantel-Haenszel|||||1.99|0.51|0.985
72585719|NCT03517540|144702779|SUPERIORITY||Odds Ratio (OR)|0.92||||0.87|TWO_SIDED|95.0|0.3|2.84|||Cochran-Mantel-Haenszel|||||2.84|0.3|0.870
72585720|NCT03517540|144702779|SUPERIORITY||Odds Ratio (OR)|1.21||||0.71|TWO_SIDED|95.0|0.41|3.61|||Cochran-Mantel-Haenszel|||||3.61|0.41|0.710
72585721|NCT03517540|144702780|SUPERIORITY||Odds Ratio (OR)|0.37||||0.136|TWO_SIDED|95.0|0.08|1.61|||Cochran-Mantel-Haenszel|||||1.61|0.08|0.136
72585722|NCT03517540|144702780|SUPERIORITY||Odds Ratio (OR)|0.83||||0.747|TWO_SIDED|95.0|0.24|2.9|||Cochran-Mantel-Haenszel|||||2.9|0.24|0.747
72585723|NCT03517540|144702780|SUPERIORITY||Odds Ratio (OR)|0.84||||0.784|TWO_SIDED|95.0|0.18|3.63|||Cochran-Mantel-Haenszel|||||3.63|0.18|0.784
72585724|NCT03517540|144702780|SUPERIORITY||Odds Ratio (OR)|1.45||||0.521|TWO_SIDED|95.0|0.4|5.69|||Cochran-Mantel-Haenszel|||||5.69|0.4|0.521
72585725|NCT01779440|144702781|SUPERIORITY|||||||0.65||||||The P-Value of 0.65 was calculated from the difference between groups for the above outcome variable.|Chi-squared|||||||0.65
72585726|NCT01408303|144702794|SUPERIORITY_OR_OTHER||LS mean difference relative to olive oil|-2.95|||<|0.05|||||||ANCOVA|p-value from ANCOVA with factors for treatment, statin use and potency, and baseline value as a covariate, and adjusted using Hommel's procedure.||||||<0.05
72585727|NCT01408303|144702794|SUPERIORITY_OR_OTHER||LS mean difference relative to olive oil|-6.0|||<|0.0001|||||||ANCOVA|p-value from ANCOVA with factors for treatment, statin use and potency, and baseline value as a covariate, and adjusted using Hommel's procedure.||||||<0.0001
72585728|NCT01938092|144702830|SUPERIORITY|||||||0.62|||||||Wilcoxon (Mann-Whitney)|||||||0.62
72585729|NCT01938092|144702831|SUPERIORITY|||||||0.66|||||||Wilcoxon (Mann-Whitney)|||||||0.66
72585730|NCT01938092|144702832|SUPERIORITY|||||||0.88|||||||Wilcoxon (Mann-Whitney)|||||||0.88
72585731|NCT01367886|144702833|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.53|STANDARD_DEVIATION|4.88||0.19|||||||t-test, 2 sided|||||||0.19
72585732|NCT01367886|144702834|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.39|STANDARD_DEVIATION|0.87||0.0021|||||||t-test, 2 sided|||||||0.0021
72585733|NCT01367886|144702835|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.34|STANDARD_DEVIATION|1.02||0.18|||||||t-test, 2 sided|||||||0.18
72585734|NCT01367886|144702836|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.38|STANDARD_DEVIATION|1.34||0.0025|||||||t-test, 2 sided|||||||0.0025
72585735|NCT00985504|144702837|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.38||||0.612|TWO_SIDED|95.0|-1.87|1.1|||Mixed Models Analysis|"The Kenward-Roger approximation was used in the MMRM model."||||1.10|-1.87|0.612
72585736|NCT00985504|144702838|SUPERIORITY_OR_OTHER|||||||0.504||95.0||||This is the p-value for Cognition Items Total Score.|Mixed Models Analysis|"The Kenward-Roger approximation was used in the MMRM model."||||||0.504
72585737|NCT00985504|144702838|SUPERIORITY_OR_OTHER|||||||0.665||95.0||||This is the p-value for the Behavior Items Total Score.|Mixed Models Analysis|"The Kenward-Roger approximation was used in the MMRM model."||||||0.665
72585738|NCT00985504|144702838|SUPERIORITY_OR_OTHER|||||||0.489||95.0||||This is the p-value for Emotional Items Total Score.|Mixed Models Analysis|"The Kenward-Roger approximation was used in the MMRM model."||||||0.489
72585739|NCT00985504|144702838|SUPERIORITY_OR_OTHER|||||||0.945||95.0||||This is the p-value for Other Items Total Score.|Mixed Models Analysis|"The Kenward-Roger approximation was used in the MMRM model."||||||0.945
72585740|NCT00985504|144702839|SUPERIORITY_OR_OTHER|||||||0.157||95.0||||This is the p-value for the Total Score.|Mixed Models Analysis|"The Kenward-Roger approximation was used in the MMRM model."||||||0.157
72585741|NCT00985504|144702839|SUPERIORITY_OR_OTHER|||||||0.119||95.0||||This is the p-value for the Energy Level score.|Mixed Models Analysis|"The Kenward-Roger approximation was used in the MMRM model."||||||0.119
72585742|NCT00985504|144702839|SUPERIORITY_OR_OTHER|||||||0.184||95.0||||This is the p-value for the Motivation and Interest score.|Mixed Models Analysis|"The Kenward-Roger approximation was used in the MMRM model."||||||0.184
72585743|NCT00985504|144702839|SUPERIORITY_OR_OTHER|||||||0.226||95.0||||This is the p-value for the Cognitive Functioning score.|Mixed Models Analysis|"The Kenward-Roger approximation was used in the MMRM model."||||||0.226
72585744|NCT00985504|144702839|SUPERIORITY_OR_OTHER|||||||0.059||95.0||||This is the p-value for the Weight Gain score.|Mixed Models Analysis|"The Kenward-Roger approximation was used in the MMRM model."||||||0.059
72585745|NCT00985504|144702839|SUPERIORITY_OR_OTHER|||||||0.466||95.0||||This is the p-value for the Sleep score.|Mixed Models Analysis|"The Kenward-Roger approximation was used in the MMRM model."||||||0.466
72585746|NCT00985504|144702839|SUPERIORITY_OR_OTHER|||||||0.822||95.0||||This is the p-value for the Sexual Functioning score.|Mixed Models Analysis|"The Kenward-Roger approximation was used in the MMRM model."||||||0.822
72585747|NCT00985504|144702839|SUPERIORITY_OR_OTHER|||||||0.599||95.0||||This is the p-value for the Affect score.|Mixed Models Analysis|"The Kenward-Roger approximation was used in the MMRM model."||||||0.599
72585748|NCT00985504|144702840|SUPERIORITY_OR_OTHER|||||||0.723||95.0||||This is the p-value for the PGI-I.|Mixed Models Analysis|"The Kenward-Roger approximation was used in the MMRM model."||||||0.723
72585749|NCT00985504|144702841|SUPERIORITY_OR_OTHER|||||||0.41||95.0|||||Mixed Models Analysis|"The Kenward-Roger approximation was used in the MMRM model."||||||0.410
72585750|NCT00985504|144702842|SUPERIORITY_OR_OTHER|||||||0.88||95.0||||This is the p-value for the Total Score.|Mixed Models Analysis|"The Kenward-Roger approximation was used in the MMRM model."||||||0.880
72585751|NCT00985504|144702842|SUPERIORITY_OR_OTHER|||||||0.224||95.0||||This is the p-value for the Item 8 (Inability to Feel) score.|Mixed Models Analysis|"The Kenward-Roger approximation was used in the MMRM model."||||||0.224
72585752|NCT00985504|144702843|SUPERIORITY_OR_OTHER|||||||0.91|TWO_SIDED|95.0||||This is the p-value for the Total Score.|ANCOVA|ANCOVA main effect F test||||||0.910
72585753|NCT00985504|144702843|SUPERIORITY_OR_OTHER|||||||0.882||95.0||||This is the p-value for the Motivation/Interest/Enthusiasm Score.|ANCOVA|ANCOVA main effect F test||||||0.882
72585754|NCT00985504|144702843|SUPERIORITY_OR_OTHER|||||||0.657||95.0||||This is the p-value for the Wakefulness/Alertness Score.|ANCOVA|ANCOVA main effect F test||||||0.657
72585755|NCT00985504|144702843|SUPERIORITY_OR_OTHER|||||||0.457||95.0||||This is the p-value for the Energy Score.|ANCOVA|ANCOVA main effect F test||||||0.457
72585756|NCT00985504|144702843|SUPERIORITY_OR_OTHER|||||||0.737||95.0||||This is the p-value for the Ability to Focus/Sustain Attention Score.|ANCOVA|ANCOVA main effect F test||||||0.737
72585757|NCT00985504|144702843|SUPERIORITY_OR_OTHER|||||||0.404||95.0||||This is the p-value for the Ability to Remember/Recall Information Score.|ANCOVA|ANCOVA main effect F test||||||0.404
72585758|NCT00985504|144702843|SUPERIORITY_OR_OTHER|||||||0.808||95.0||||This is the p-value for the Ability to Find Words Score.|ANCOVA|ANCOVA main effect F test||||||0.808
72585759|NCT00985504|144702843|SUPERIORITY_OR_OTHER|||||||0.431||95.0||||This is the p-value for the Sharpness/Mental Acuity Score.|ANCOVA|ANCOVA main effect F test||||||0.431
72585760|NCT00985504|144702844|SUPERIORITY_OR_OTHER|||||||0.821||95.0||||This is the p-value for the SDS Total Score.|ANCOVA|ANCOVA main effect F test||||||0.821
72585761|NCT00985504|144702844|SUPERIORITY_OR_OTHER|||||||0.491||95.0||||This is the p-value for the Item 1 (Work) Score.|ANCOVA|ANCOVA main effect F test||||||0.491
72585762|NCT00985504|144702844|SUPERIORITY_OR_OTHER|||||||0.451||95.0||||This is the p-value for the Item 2 (Family) Score.|ANCOVA|ANCOVA main effect F test||||||0.451
72585763|NCT00985504|144702844|SUPERIORITY_OR_OTHER|||||||0.443||95.0||||This is the p-value for the Item 3 (Social) Score.|ANCOVA|ANCOVA main effect F test||||||0.443
72585764|NCT00985504|144702844|SUPERIORITY_OR_OTHER|||||||0.719||95.0||||This is the p-value for the Item 4 (Days Lost) Score.|ANCOVA|ANCOVA main effect F test||||||0.719
72585765|NCT00985504|144702844|SUPERIORITY_OR_OTHER|||||||0.517||95.0||||This is the p-value for the Item 5 (Days Underproductive) Score.|ANCOVA|ANCOVA main effect F test||||||0.517
72585766|NCT00985504|144702845|SUPERIORITY_OR_OTHER|||||||0.776||95.0|||||Fisher Exact|||||||0.776
72585767|NCT00985504|144702846|SUPERIORITY_OR_OTHER|||||||0.691||95.0|||||Log Rank|||The log-rank test was conducted using Kaplan-Meier Product-Limit method.||||0.691
72585768|NCT00985504|144702847|SUPERIORITY_OR_OTHER|||||||0.724||95.0|||||Fisher Exact|||||||0.724
72585769|NCT03711786|144702850|SUPERIORITY||Odds Ratio (OR)|1.2||||0.836|TWO_SIDED|95.0|0.22|6.65|||Regression - GEE, logistic|From Wald z-statistic from generalized estimating equations (GEE) model with bias-corrected standard error|Enhanced arm (index) compared to basic arm (referent). GEE model with bias-corrected standard errors.|||6.65|0.22|0.836
72585770|NCT03711786|144702851|SUPERIORITY||Odds Ratio (OR)|0.86||||0.877|TWO_SIDED|95.0|0.12|6.14|||Regression - GEE, logistic|From Wald z-statistic from GEE model with bias-corrected standard error|Enhanced arm (index) compared to basic arm (referent). GEE model with bias-corrected standard errors.|||6.14|0.12|0.877
72585771|NCT03711786|144702852|SUPERIORITY||Odds Ratio (OR)|18.36||||0.001|TWO_SIDED|95.0|3.23|104.23|||Regression - GEE, logistic|From Wald z-statistic from GEE model with bias-corrected standard error|Enhanced arm (index) compared to basic arm (referent). GEE model with bias-corrected standard errors.|||104.23|3.23|0.001
72585772|NCT03711786|144702853|SUPERIORITY||Odds Ratio (OR)|2.15||||0.017|TWO_SIDED|95.0|1.15|4.01|||Regression - GEE, logistic|From Wald z-statistic from GEE model with bias-corrected standard error|Enhanced arm (index) compared to basic arm (referent). GEE model with bias-corrected standard errors.|||4.01|1.15|0.017
72585773|NCT03711786|144702854|SUPERIORITY||Odds Ratio (OR)|0.9||||0.759|TWO_SIDED|95.0|0.45|1.8|||Regression - GEE, logistic|From Wald z-statistic from GEE model with bias-corrected standard error|Enhanced arm (index) compared to basic arm (referent). GEE model with bias-corrected standard errors.|||1.80|0.45|0.759
72585774|NCT04031846|144702860|OTHER|Difference in % and 95 % confidence interval (CI) are calculated based on the Miettinen \& Nurminen method.|Percentage Difference|0.6|||=|0.824|TWO_SIDED|95.0|-5.0|6.3|||Miettinen & Nurminen||V114 minus Prevenar 13™|Difference in % : Injection site erythema||6.3|-5.0|= 0.824
72585775|NCT04031846|144702860|OTHER|Difference in % and 95 % CI are calculated based on the Miettinen \& Nurminen method.|Percentage Difference|2.8|||=|0.324|TWO_SIDED|95.0|-2.8|8.4|||Miettinen & Nurminen||V114 minus Prevenar 13™|Difference in %: Injection site induration||8.4|-2.8|= 0.324
72585776|NCT04031846|144702860|OTHER|Difference in % and 95 % CI are calculated based on the Miettinen \& Nurminen method.|Percentage Difference|11.3|||<|0.001|TWO_SIDED|95.0|5.8|16.6|||Miettinen & Nurminen||V114 minus Prevenar 13™|Difference in %: Injection site pain||16.6|5.8|< 0.001
72585777|NCT04031846|144702860|OTHER|Difference in % and 95 % CI are calculated based on the Miettinen \& Nurminen method.|Percentage Difference|4.1|||=|0.128|TWO_SIDED|95.0|-1.2|9.4|||Miettinen & Nurminen||V114 minus Prevenar 13™|Difference in %: Injection site swelling||9.4|-1.2|= 0.128
72585778|NCT04031846|144702861|OTHER|Difference in % and 95 % CI are calculated based on the Miettinen \& Nurminen method.|Percentage Difference|0.4|||=|0.885|TWO_SIDED|95.0|-5.0|5.8|||Miettinen & Nurminen||V114 minus Prevenar 13™|Difference in %: Decreased appetite||5.8|-5.0|= 0.885
72585779|NCT04031846|144702861|OTHER|Difference in % and 95 % CI are calculated based on the Miettinen \& Nurminen method.|Percentage Difference|5.4|||=|0.045|TWO_SIDED|95.0|0.1|10.7|||Miettinen & Nurminen||V114 minus Prevenar 13™|Difference in %: Irritability||10.7|0.1|= 0.045
72585780|NCT04031846|144702861|OTHER|Difference in % and 95 % CI are calculated based on the Miettinen \& Nurminen method.|Percentage Difference|4.4|||=|0.131|TWO_SIDED|95.0|-1.3|10.0|||Miettinen & Nurminen||V114 minus Prevenar 13™|Difference in %: Somnolence||10.0|-1.3|= 0.131
72585781|NCT04031846|144702861|OTHER|Difference in % and 95 % CI are calculated based on the Miettinen \& Nurminen method.|Percentage Difference|-0.1|||=|0.898|TWO_SIDED|95.0|-2.4|2.1|||Miettinen & Nurminen||V114 minus Prevenar 13™|Difference in %: Urticaria||2.1|-2.4|= 0.898
72585782|NCT04031846|144702862|OTHER|Difference in % and 95 % CI are calculated based on the Miettinen \& Nurminen method.|Percentage Difference|-0.2|||||TWO_SIDED|95.0|-1.0|0.5|||||V114 minus Prevenar 13™|Difference in %||0.5|-1.0|
72585783|NCT04031846|144702863|NON_INFERIORITY|Non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevenar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio|0.62|||<|0.001|TWO_SIDED|95.0|0.57|0.68||1-sided p-value|t-distribution||V114/Prevenar 13™|Serotype 1 GMC Ratio: CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||0.68|0.57|< 0.001
72585784|NCT04031846|144702863|NON_INFERIORITY|Non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevenar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio|1.28|||<|0.001|TWO_SIDED|95.0|1.17|1.39||1-sided p-value|t-distribution||V114/Prevenar 13™|Serotype 3 GMC Ratio: CI and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||1.39|1.17|< 0.001
72585785|NCT04031846|144702863|NON_INFERIORITY|Non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevenar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio|0.75|||<|0.001|TWO_SIDED|95.0|0.68|0.82||1-sided p-value|t-distribution||V114/Prevenar 13™|Serotype 4 GMC Ratio: CI and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||0.82|0.68|< 0.001
72585786|NCT04031846|144702863|NON_INFERIORITY|Non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevenar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio|0.64|||<|0.001|TWO_SIDED|95.0|0.59|0.7||1-sided p-value|t-distribution||V114/Prevenar 13™|Serotype 5 GMC Ratio: CI and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||0.70|0.59|< 0.001
72585787|NCT04031846|144702863|NON_INFERIORITY|Non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevenar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio|0.68|||<|0.001|TWO_SIDED|95.0|0.61|0.76||1-sided p-value|t-distribution||V114/Prevenar 13™|Serotype 6A GMC Ratio: CI and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||0.76|0.61|< 0.001
72585788|NCT04031846|144702863|NON_INFERIORITY|Non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevenar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio|0.95|||<|0.001|TWO_SIDED|95.0|0.85|1.07||1-sided p-value|t-distribution||V114/Prevenar 13™|Serotype 6B GMC Ratio: CI and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||1.07|0.85|< 0.001
72585789|NCT04031846|144702863|NON_INFERIORITY|Non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevenar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio|0.79|||<|0.001|TWO_SIDED|95.0|0.72|0.85||1-sided p-value|t-distribution||V114/Prevenar 13™|Serotype 7F GMC Ratio: CI and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||0.85|0.72|< 0.001
72585790|NCT04031846|144702863|NON_INFERIORITY|Non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevenar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio|0.72|||<|0.001|TWO_SIDED|95.0|0.66|0.78||1-sided p-value|t-distribution||V114/Prevenar 13™|Serotype 9V GMC Ratio: CI and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||0.78|0.66|< 0.001
72585791|NCT04031846|144702863|NON_INFERIORITY|Non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevenar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio|0.75|||<|0.001|TWO_SIDED|95.0|0.67|0.83||1-sided p-value|t-distribution||V114/Prevenar 13™|Serotype 14 GMC Ratio: CI and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||0.83|0.67|< 0.001
72585792|NCT04031846|144702863|NON_INFERIORITY|Non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevenar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio|0.88|||<|0.001|TWO_SIDED|95.0|0.8|0.95||1-sided p-value|t-distribution||V114/Prevenar 13™|Serotype 18C GMC Ratio: CI and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||0.95|0.80|< 0.001
72585793|NCT04031846|144702863|NON_INFERIORITY|Non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevenar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio|0.83|||<|0.001|TWO_SIDED|95.0|0.75|0.91||1-sided p-value|t-distribution||V114/Prevenar 13™|Serotype 19A GMC Ratio: CI and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||0.91|0.75|< 0.001
72585794|NCT04031846|144702863|NON_INFERIORITY|Non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevenar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio|0.88|||<|0.001|TWO_SIDED|95.0|0.8|0.97||1-sided p-value|t-distribution||V114/Prevenar 13™|Serotype 19F GMC Ratio: CI and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||0.97|0.80|< 0.001
72585795|NCT04031846|144702863|NON_INFERIORITY|Non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevenar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio|0.87|||<|0.001|TWO_SIDED|95.0|0.79|0.97||1-sided p-value|t-distribution||V114/Prevenar 13™|Serotype 23F GMC Ratio: CI and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||0.97|0.79|< 0.001
72585796|NCT04031846|144702863|SUPERIORITY|Superiority of V114 to Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevenar 13™) being \>2.0 (1-sided p-value \<0.025).|GMC Ratio|71.79|||<|0.001|TWO_SIDED|95.0|65.16|79.1||1-sided p-value|t-distribution||V114/Prevenar 13™|Serotype 22F GMC Ratio: CI and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||79.10|65.16|< 0.001
72585797|NCT04031846|144702863|SUPERIORITY|Superiority of V114 to Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevenar 13™) being \>2.0 (1-sided p-value \<0.025).|GMC Ratio|46.58|||<|0.001|TWO_SIDED|95.0|42.19|51.42||1-sided p-value|t-distribution||V114/Prevenar 13™|Serotype 33F GMC Ratio: CI and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||51.42|42.19|< 0.001
72585798|NCT04031846|144702864|NON_INFERIORITY|Non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 95% CI for the difference in percentages (V114 - Prevenar 13™) being \>-10 percentage points (1-sided p-value \<0.025).|Percentage Difference|-2.8|||<|0.001|TWO_SIDED|95.0|-4.7|-1.3||1-sided p-value|Miettinen & Nurminen||V114 minus Prevenar 13™|Percentage Difference: Serotype 1|95% CI is based on the Miettinen \& Nurminen method.|-1.3|-4.7|< 0.001
72585799|NCT04031846|144702864|NON_INFERIORITY|Non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 95% CI for the difference in percentages (V114 - Prevenar 13™) being \>-10 percentage points (1-sided p-value \<0.025).|Percentage Difference|8.2|||<|0.001|TWO_SIDED|95.0|4.4|12.2||1-sided p-value|Miettinen & Nurminen||V114 minus Prevenar 13™|Percentage Difference: Serotype 3|95% CI is based on the Miettinen \& Nurminen method.|12.2|4.4|< 0.001
72585800|NCT04031846|144702864|NON_INFERIORITY|Non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 95% CI for the difference in percentages (V114 - Prevenar 13™) being \>-10 percentage points (1-sided p-value \<0.025).|Percentage Difference|-2.2|||<|0.001|TWO_SIDED|95.0|-4.5|-0.1||1-sided p-value|Miettinen & Nurminen||V114 minus Prevenar 13™|Percentage Difference: Serotype 4|95% CI is based on the Miettinen \& Nurminen method.|-0.1|-4.5|< 0.001
72585801|NCT04031846|144702864|NON_INFERIORITY|Non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 95% CI for the difference in percentages (V114 - Prevenar 13™) being \>-10 percentage points (1-sided p-value \<0.025).|Percentage Difference|-0.9|||<|0.001|TWO_SIDED|95.0|-2.2|-0.2||1-sided p-value|Miettinen & Nurminen||V114 minus Prevenar 13™|Percentage Difference: Serotype 5|95% CI is based on the Miettinen \& Nurminen method.|-0.2|-2.2|< 0.001
72585802|NCT04031846|144702864|NON_INFERIORITY|Non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 95% CI for the difference in percentages (V114 - Prevenar 13™) being \>-10 percentage points (1-sided p-value \<0.025).|Percentage Difference|-0.4|||<|0.001|TWO_SIDED|95.0|-1.9|1.1||1-sided p-value|Miettinen & Nurminen||V114 minus Prevenar 13™|Percentage Difference: Serotype 6A|95% CI is based on the Miettinen \& Nurminen method.|1.1|-1.9|< 0.001
72585803|NCT04031846|144702864|NON_INFERIORITY|Non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 95% CI for the difference in percentages (V114 - Prevenar 13™) being \>-10 percentage points (1-sided p-value \<0.025).|Percentage Difference|-1.7|||<|0.001|TWO_SIDED|95.0|-3.5|-0.1||1-sided p-value|Miettinen & Nurminen||V114 minus Prevenar 13™|Percentage Difference: Serotype 6B|95% CI is based on the Miettinen \& Nurminen method.|-0.1|-3.5|< 0.001
72585804|NCT04031846|144702864|NON_INFERIORITY|Non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 95% CI for the difference in percentages (V114 - Prevenar 13™) being \>-10 percentage points (1-sided p-value \<0.025).|Percentage Difference|0.0|||<|0.001|TWO_SIDED|95.0|-0.9|0.9||1-sided p-value|Miettinen & Nurminen||V114 minus Prevenar 13™|Percentage Difference: Serotype 7F|95% CI is based on the Miettinen \& Nurminen method.|0.9|-0.9|< 0.001
72585805|NCT04031846|144702864|NON_INFERIORITY|Non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 95% CI for the difference in percentages (V114 - Prevenar 13™) being \>-10 percentage points (1-sided p-value \<0.025).|Percentage Difference|-1.1|||<|0.001|TWO_SIDED|95.0|-2.4|-0.4||1-sided p-value|Miettinen & Nurminen||V114 minus Prevenar 13™|Percentage Difference: Serotype 9V|95% CI is based on the Miettinen \& Nurminen method.|-0.4|-2.4|< 0.001
72585806|NCT04031846|144702864|NON_INFERIORITY|Non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 95% CI for the difference in percentages (V114 - Prevenar 13™) being \>-10 percentage points (1-sided p-value \<0.025).|Percentage Difference|-0.2|||<|0.001|TWO_SIDED|95.0|-1.0|0.5||1-sided p-value|Miettinen & Nurminen||V114 minus Prevenar 13™|Percentage Difference: Serotype 14|95% CI is based on the Miettinen \& Nurminen method.|0.5|-1.0|< 0.001
72585807|NCT04031846|144702864|NON_INFERIORITY|Non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 95% CI for the difference in percentages (V114 - Prevenar 13™) being \>-10 percentage points (1-sided p-value \<0.025).|Percentage Difference|-0.4|||<|0.001|TWO_SIDED|95.0|-1.8|0.9||1-sided p-value|Miettinen & Nurminen||V114 minus Prevenar 13™|Percentage Difference: Serotype 18C|95% CI is based on the Miettinen \& Nurminen method.|0.9|-1.8|< 0.001
72585808|NCT04031846|144702864|NON_INFERIORITY|Non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 95% CI for the difference in percentages (V114 - Prevenar 13™) being \>-10 percentage points (1-sided p-value \<0.025).|Percentage Difference|-0.9|||<|0.001|TWO_SIDED|95.0|-2.2|-0.2||1-sided p-value|Miettinen & Nurminen||V114 minus Prevenar 13™|Percentage Difference: Serotype 19A|95% CI is based on the Miettinen \& Nurminen method.|-0.2|-2.2|< 0.001
72585809|NCT04031846|144702864|NON_INFERIORITY|Non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 95% CI for the difference in percentages (V114 - Prevenar 13™) being \>-10 percentage points (1-sided p-value \<0.025).|Percentage Difference|-0.4|||<|0.001|TWO_SIDED|95.0|-1.3|0.3||1-sided p-value|Miettinen & Nurminen||V114 minus Prevenar 13™|Percentage Difference: Serotype 19F|95% CI is based on the Miettinen \& Nurminen method.|0.3|-1.3|< 0.001
72585810|NCT04031846|144702864|NON_INFERIORITY|Non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 95% CI for the difference in percentages (V114 - Prevenar 13™) being \>-10 percentage points (1-sided p-value \<0.025).|Percentage Difference|-0.5|||<|0.001|TWO_SIDED|95.0|-2.7|1.5||1-sided p-value|Miettinen & Nurminen||V114 minus Prevenar 13™|Percentage Difference: Serotype 23F|95% CI is based on the Miettinen \& Nurminen method.|1.5|-2.7|< 0.001
72585811|NCT04031846|144702864|SUPERIORITY|Superiority of V114 to Prevenar 13™ is based on the lower bound of the 95% CI for the difference in percentages (V114 - Prevenar 13™) being \>10 percentage points (1-sided p-value \<0.025).|Percentage Difference|93.8|||<|0.001|TWO_SIDED|95.0|91.5|95.6||1-sided p-value|Miettinen & Nurminen||V114 minus Prevenar 13™|Percentage Difference: Serotype 22F|95% CI is based on the Miettinen \& Nurminen method.|95.6|91.5|< 0.001
72585812|NCT04031846|144702864|SUPERIORITY|Superiority of V114 to Prevenar 13™ is based on the lower bound of the 95% CI for the difference in percentages (V114 - Prevenar 13™) being \>10 percentage points (1-sided p-value \<0.025).|Percentage Difference|94.9|||<|0.001|TWO_SIDED|95.0|92.7|96.5||1-sided p-value|Miettinen & Nurminen||V114 minus Prevenar 13™|Percentage Difference: Serotype 33F|95% CI is based on the Miettinen \& Nurminen method.|96.5|92.7|< 0.001
72585813|NCT04031846|144702865|NON_INFERIORITY|Non-inferiority of Infanrix™ hexa administered concomitantly with V114 to Infanrix™ hexa administered concomitantly with Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevenar 13™) being greater than the -10% specified non-inferiority margin (1-sided p-value \<0.025).|Percentage Difference|-0.6|||<|0.001|TWO_SIDED|95.0|-1.7|0.4||1-sided p-value|Miettinen & Nurminen||V114 minus Prevenar 13™|Percentage Difference: Diphtheria toxoid|95% CI is based on the Miettinen \& Nurminen method.|0.4|-1.7|< 0.001
72585814|NCT04031846|144702865|NON_INFERIORITY|Non-inferiority of Infanrix™ hexa administered concomitantly with V114 to Infanrix™ hexa administered concomitantly with Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevenar 13™) being greater than the -5% specified non-inferiority margin (1-sided p-value \<0.025).|Percentage Difference|-0.4|||<|0.001|TWO_SIDED|95.0|-1.3|0.3||1-sided p-value|Miettinen & Nurminen||V114 minus Prevenar 13™|Percentage Difference: Tetanus toxoid|95% CI is based on the Miettinen \& Nurminen method.|0.3|-1.3|< 0.001
72585815|NCT04031846|144702865|NON_INFERIORITY|Non-inferiority of Infanrix™ hexa administered concomitantly with V114 to Infanrix™ hexa administered concomitantly with Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevenar 13™) being greater than the -10% specified non-inferiority margin (1-sided p-value \<0.025).|Percentage Difference|-0.2|||<|0.001|TWO_SIDED|95.0|-1.3|0.9||1-sided p-value|Miettinen & Nurminen||V114 minus Prevenar 13™|Percentage Difference: Pertussis PT|95% CI is based on the Miettinen \& Nurminen method.|0.9|-1.3|< 0.001
72585816|NCT04031846|144702865|NON_INFERIORITY|Non-inferiority of Infanrix™ hexa administered concomitantly with V114 to Infanrix™ hexa administered concomitantly with Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevenar 13™) being greater than the -10% specified non-inferiority margin (1-sided p-value \<0.025).|Percentage Difference|-0.2|||<|0.001|TWO_SIDED|95.0|-1.0|0.5||1-sided p-value|Miettinen & Nurminen||V114 minus Prevenar 13™|Percentage Difference: Pertussis FHA|95% CI is based on the Miettinen \& Nurminen method.|0.5|-1.0|< 0.001
72585817|NCT04031846|144702865|NON_INFERIORITY|Non-inferiority of Infanrix™ hexa administered concomitantly with V114 to Infanrix™ hexa administered concomitantly with Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevenar 13™) being greater than the -10% specified non-inferiority margin (1-sided p-value \<0.025).|Percentage Difference|-0.4|||<|0.001|TWO_SIDED|95.0|-1.3|0.3||1-sided p-value|Miettinen & Nurminen||V114 minus Prevenar 13™|Percentage Difference: Pertussis PRN|95% CI is based on the Miettinen \& Nurminen method.|0.3|-1.3|< 0.001
72585818|NCT04031846|144702865|NON_INFERIORITY|Non-inferiority of Infanrix™ hexa administered concomitantly with V114 to Infanrix™ hexa administered concomitantly with Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevenar 13™) being greater than the -10% specified non-inferiority margin (1-sided p-value \<0.025).|Percentage Difference|0.4|||<|0.001|TWO_SIDED|95.0|-1.3|2.1||1-sided p-value|Miettinen & Nurminen||V114 minus Prevenar 13™|Percentage Difference: Hib PRP|95% CI is based on the Miettinen \& Nurminen method.|2.1|-1.3|< 0.001
72585819|NCT04031846|144702865|NON_INFERIORITY|Non-inferiority of Infanrix™ hexa administered concomitantly with V114 to Infanrix™ hexa administered concomitantly with Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevenar 13™) being greater than the -10% specified non-inferiority margin (1-sided p-value \<0.025).|Percentage Difference|-0.8|||<|0.001|TWO_SIDED|95.0|-2.0|0.0||1-sided p-value|Miettinen & Nurminen||V114 minus Prevenar 13™|Percentage Difference: HBsAg|95% CI is based on the Miettinen \& Nurminen method.|-0.0|-2.0|< 0.001
72585820|NCT04031846|144702865|NON_INFERIORITY|Non-inferiority of Infanrix™ hexa administered concomitantly with V114 to Infanrix™ hexa administered concomitantly with Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevenar 13™) being greater than the -5% specified non-inferiority margin (1-sided p-value \<0.025).|Percentage Difference|0.0|||<|0.001|TWO_SIDED|95.0|-0.7|0.7||1-sided p-value|Miettinen & Nurminen||V114 minus Prevenar 13™|Percentage Difference: Poliovirus 1|95% CI is based on the Miettinen \& Nurminen method.|0.7|-0.7|< 0.001
72585821|NCT04031846|144702865|NON_INFERIORITY|Non-inferiority of Infanrix™ hexa administered concomitantly with V114 to Infanrix™ hexa administered concomitantly with Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevenar 13™) being greater than the -5% specified non-inferiority margin (1-sided p-value \<0.025).|Percentage Difference|0.0|||<|0.001|TWO_SIDED|95.0|-0.7|0.7||1-sided p-value|Miettinen & Nurminen||V114 minus Prevenar 13™|Percentage Difference: Poliovirus 2|95% CI is based on the Miettinen \& Nurminen method.|0.7|-0.7|< 0.001
72585822|NCT04031846|144702865|NON_INFERIORITY|Non-inferiority of Infanrix™ hexa administered concomitantly with V114 to Infanrix™ hexa administered concomitantly with Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevenar 13™) being greater than the -5% specified non-inferiority margin (1-sided p-value \<0.025).|Percentage Difference|0.2|||<|0.001|TWO_SIDED|95.0|-0.5|1.1||1-sided p-value|Miettinen & Nurminen||V114 minus Prevenar 13™|Percentage Difference: Poliovirus 3|95% CI is based on the Miettinen \& Nurminen method.|1.1|-0.5|< 0.001
72585823|NCT04031846|144702866|NON_INFERIORITY|Non-inferiority of Rotarix™ administered concomitantly with V114 to Rotarix™ administered concomitantly with Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the GMT ratio (V114/Prevenar 13™) being \>0.5 (1-sided p-value \<0.025).|GMT Ratio|0.96|||<|0.001|TWO_SIDED|95.0|0.8|1.16||1-sided p-value|t-distribution||V114/Prevenar 13™|GMT Ratio: CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group||1.16|0.80|< 0.001
72585824|NCT04031846|144702867|OTHER||GMC Ratio|0.8|||||TWO_SIDED|95.0|0.73|0.88|||||V114 / Prevenar 13™|GMC Ratio Serotype 1: CI are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||0.88|0.73|
72585825|NCT04031846|144702867|OTHER||GMC Ratio|1.85|||||TWO_SIDED|95.0|1.7|2.02|||||V114 / Prevenar 13™|GMC Ratio Serotype 3: CI are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||2.02|1.70|
72585826|NCT04031846|144702867|OTHER||GMC Ratio|1.08|||||TWO_SIDED|95.0|0.98|1.19|||||V114 / Prevenar 13™|GMC Ratio Serotype 4: CI are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||1.19|0.98|
72585827|NCT04031846|144702867|OTHER||GMC Ratio|0.84|||||TWO_SIDED|95.0|0.74|0.94|||||V114 / Prevenar 13™|GMC Ratio Serotype 5: CI are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||0.94|0.74|
72585828|NCT04031846|144702867|OTHER||GMC Ratio|0.45|||||TWO_SIDED|95.0|0.4|0.52|||||V114 / Prevenar 13™|GMC Ratio Serotype 6A: CI are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||0.52|0.40|
72585829|NCT04031846|144702867|OTHER||GMC Ratio|1.18|||||TWO_SIDED|95.0|1.0|1.41|||||V114 / Prevenar 13™|GMC Ratio Serotype 6B: CI are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||1.41|1.00|
72585830|NCT04031846|144702867|OTHER||GMC Ratio|0.83|||||TWO_SIDED|95.0|0.76|0.91|||||V114 / Prevenar 13™|GMC Ratio Serotype 7F: CI are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||0.91|0.76|
72585831|NCT04031846|144702867|OTHER||GMC Ratio|0.86|||||TWO_SIDED|95.0|0.77|0.96|||||V114 / Prevenar 13™|GMC Ratio Serotype 9V: CI are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||0.96|0.77|
72585832|NCT04031846|144702867|OTHER||GMC Ratio|0.75|||||TWO_SIDED|95.0|0.66|0.86|||||V114 / Prevenar 13™|GMC Ratio Serotype 14: CI are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||0.86|0.66|
72585833|NCT04031846|144702867|OTHER||GMC Ratio|0.85|||||TWO_SIDED|95.0|0.77|0.95|||||V114 / Prevenar 13™|GMC Ratio Serotype 18C: CI are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||0.95|0.77|
72585834|NCT04031846|144702867|OTHER||GMC Ratio|0.78|||||TWO_SIDED|95.0|0.7|0.87|||||V114 / Prevenar 13™|GMC Ratio Serotype 19A: CI are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||0.87|0.70|
72585835|NCT04031846|144702867|OTHER||GMC Ratio|0.77|||||TWO_SIDED|95.0|0.7|0.85|||||V114 / Prevenar 13™|GMC Ratio Serotype 19F: CI are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||0.85|0.70|
72585836|NCT04031846|144702867|OTHER||GMC Ratio|1.22|||||TWO_SIDED|95.0|1.07|1.4|||||V114 / Prevenar 13™|GMC Ratio Serotype 23F: CI are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||1.40|1.07|
72585837|NCT04031846|144702867|OTHER||GMC Ratio|57.69|||||TWO_SIDED|95.0|51.2|65.0|||||V114 / Prevenar 13™|GMC Ratio Serotype 22F: CI are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||65.00|51.20|
72585838|NCT04031846|144702867|OTHER||GMC Ratio|6.24|||||TWO_SIDED|95.0|5.46|7.14|||||V114 / Prevenar 13™|GMC Ratio Serotype 33F: CI are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||7.14|5.46|
72585839|NCT04031846|144702868|OTHER||Percentage Difference|-2.0|||||TWO_SIDED|95.0|-4.4|0.3|||||V114 minus Prevenar 13™|Percentage Difference: Serotype 1|95% CI are based on the Miettinen \& Nurminen method.|0.3|-4.4|
72585840|NCT04031846|144702868|OTHER||Percentage Difference|25.7|||||TWO_SIDED|95.0|21.1|30.3|||||V114 minus Prevenar 13™|Percentage Difference: Serotype 3|95% CI are based on the Miettinen \& Nurminen method.|30.3|21.1|
72585841|NCT04031846|144702868|OTHER||Percentage Difference|-2.9|||||TWO_SIDED|95.0|-5.7|-0.3|||||V114 minus Prevenar 13™|Percentage Difference: Serotype 4|95% CI are based on the Miettinen \& Nurminen method.|-0.3|-5.7|
72585842|NCT04031846|144702868|OTHER||Percentage Difference|-3.9|||||TWO_SIDED|95.0|-8.1|0.3|||||V114 minus Prevenar 13™|Percentage Difference: Serotype 5|95% CI are based on the Miettinen \& Nurminen method.|0.3|-8.1|
72585843|NCT04031846|144702868|OTHER||Percentage Difference|-19.4|||||TWO_SIDED|95.0|-23.9|-15.0|||||V114 minus Prevenar 13™|Percentage Difference: Serotype 6A|95% CI are based on the Miettinen \& Nurminen method.|-15.0|-23.9|
72585844|NCT04031846|144702868|OTHER||Percentage Difference|4.6|||||TWO_SIDED|95.0|-1.5|10.7|||||V114 minus Prevenar 13™|Percentage Difference: Serotype 6B|95% CI are based on the Miettinen \& Nurminen method.|10.7|-1.5|
72585845|NCT04031846|144702868|OTHER||Percentage Difference|-1.1|||||TWO_SIDED|95.0|-2.9|0.5|||||V114 minus Prevenar 13™|Percentage Difference: Serotype 7F|95% CI are based on the Miettinen \& Nurminen method.|0.5|-2.9|
72585846|NCT04031846|144702868|OTHER||Percentage Difference|-6.7|||||TWO_SIDED|95.0|-10.1|-3.5|||||V114 minus Prevenar 13™|Percentage Difference: Serotype 9V|95% CI are based on the Miettinen \& Nurminen method.|-3.5|-10.1|
72585847|NCT04031846|144702868|OTHER||Percentage Difference|-0.5|||||TWO_SIDED|95.0|-2.6|1.7|||||V114 minus Prevenar 13™|Percentage Difference: Serotype 14|95% CI are based on the Miettinen \& Nurminen method.|1.7|-2.6|
72585848|NCT04031846|144702868|OTHER||Percentage Difference|-0.7|||||TWO_SIDED|95.0|-3.9|2.6|||||V114 minus Prevenar 13™|Percentage Difference: Serotype 18C|95% CI are based on the Miettinen \& Nurminen method.|2.6|-3.9|
72585849|NCT04031846|144702868|OTHER||Percentage Difference|-1.2|||||TWO_SIDED|95.0|-3.5|1.0|||||V114 minus Prevenar 13™|Percentage Difference: Serotype 19A|95% CI are based on the Miettinen \& Nurminen method.|1.0|-3.5|
72585850|NCT04031846|144702868|OTHER||Percentage Difference|-0.5|||||TWO_SIDED|95.0|-2.0|0.7|||||V114 minus Prevenar 13™|Percentage Difference: Serotype 19F|95% CI are based on the Miettinen \& Nurminen method.|0.7|-2.0|
72585851|NCT04031846|144702868|OTHER||Percentage Difference|6.6|||||TWO_SIDED|95.0|1.3|11.9|||||V114 minus Prevenar 13™|Percentage Difference: Serotype 23F|95% CI are based on the Miettinen \& Nurminen method.|11.9|1.3|
72585852|NCT04031846|144702868|OTHER||Percentage Difference|90.4|||||TWO_SIDED|95.0|87.4|92.7|||||V114 minus Prevenar 13™|Percentage Difference: Serotype 22F|95% CI are based on the Miettinen \& Nurminen method.|92.7|87.4|
72585853|NCT04031846|144702868|OTHER||Percentage Difference|45.9|||||TWO_SIDED|95.0|41.3|50.3|||||V114 minus Prevenar 13™|Percentage Difference: Serotype 33F|95% CI are based on the Miettinen \& Nurminen method.|50.3|41.3|
72585854|NCT04031846|144702871|OTHER|Percentage difference and CI are based on the Miettinen \& Nurminen method.|Percentage Difference|15.8|||||TWO_SIDED|95.0|12.9|19.2|||||V114 minus Prevenar 13™|Percentage Difference: V114 Serotype 22F minus Prevenar 13™ Serotype 3||19.2|12.9|
72413819|NCT01306162|144336830|NON_INFERIORITY_OR_EQUIVALENCE|Bioavailability|Geometric mean ratio TrtD: TrtA (%)|225.0|STANDARD_DEVIATION|26.1||0.9946||90.0|156.0|326.0||p-value for geometric mean ratio being outside interval 80% to 125%|ANOVA|ANOVA with sequence, period and treatment as fixed effects and subject within sequence as random effect.|The standard deviation is actually the Geometric coefficient of variation|150mg DE + 400mg DR bid same time (TrtD) vs 150mg DE (TrtA)||326|156|0.9946
72585855|NCT04031846|144702871|OTHER|Percentage difference and CI are based on the Miettinen \& Nurminen method.|Percentage Difference|15.3|||||TWO_SIDED|95.0|12.2|18.7|||||V114 minus Prevenar 13™|Percentage Difference: V114 Serotype 33F minus Prevenar 13™ Serotype 3||18.7|12.2|
72585856|NCT06868654|144702872|OTHER||Hazard Ratio (HR)|0.24|||||TWO_SIDED|95.0|0.11|0.56|||||Hazard ratio was estimated using a Cox Proportional Hazards model stratified by the number of lines of prior therapy, prior bortezomib and revised international staging system (R-ISS) at screening, with a covariate of treatment.|||0.56|0.11|
72585857|NCT01022307|144702895|NON_INFERIORITY_OR_EQUIVALENCE|Power analysis showed that the effect size was small, with a 50% chance of detecting a p \< 0.05 effect requiring 247 subjects.|||||<|0.04|TWO_SIDED||||||F-test|Greenhouse Geisser correction.||F-test evaluating effects of Group||||< 0.04
72585858|NCT00764660|144702913|SUPERIORITY_OR_OTHER||Difference in LS Means|2.4||||0.41|TWO_SIDED|95.0|-3.4|8.2|||Repeated Measures Model||Repeated Measures Model with factors for treatment, pooled centers, assessment and assessment by treatment interaction.|||8.2|-3.4|0.41
72585859|NCT00764660|144702914|SUPERIORITY_OR_OTHER||Difference in Least Squares (LS) Means|-1.9||||0.3|TWO_SIDED|95.0|-5.5|1.7|||Repeated Measures Model||Repeated Measures Model with factors for treatment, pooled centers, assessment and assessment by treatment interaction.|||1.7|-5.5|0.30
72585860|NCT00764660|144702915|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.87||||0.52|TWO_SIDED|95.0|0.57|1.33|||Chi-squared|Zero Inflated Negative Binomial (ZINB) Distribution with terms for treatment and region||||1.33|0.57|0.52
72585861|NCT00764660|144702916|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.96||||0.81|TWO_SIDED|95.0|0.71|1.31|||Chi-squared|ZINB Distribution with terms for treatment and region||||1.31|0.71|0.81
72585862|NCT00764660|144702917|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.31||||0.26|TWO_SIDED|95.0|0.81|2.12||Model with factors treatment and pooled centers as stratum.|Kaplan-Meier|||||2.12|0.81|0.26
72585863|NCT00764660|144702918|SUPERIORITY_OR_OTHER||Difference in LS Means|-2.1||||0.59|TWO_SIDED|95.0|-9.9|5.7|||Repeated Measures Model|Repeated Measures Model with factors for treatment, pooled centers, assessment and assessment by treatment interaction.||||5.7|-9.9|0.59
72585864|NCT00764660|144702919|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.5||||0.34|TWO_SIDED|95.0|0.65|3.43|||Regression, Logistic|An Odds Ratio (SCH 900435/Placebo) \>1 means SCH 900435 has a higher probability of achieving complete abstinence.||||3.43|0.65|0.34
72585865|NCT00764660|144702922|SUPERIORITY_OR_OTHER||Difference in LS Means|2.88||||0.54|TWO_SIDED|95.0|-6.3|12.06|||Contrained Longitudinal Data Analysis||Constrained Longitudinal Data Analysis (cLDA) Model with terms for treatment, pooled centers, assessment by treatment interaction.|||12.06|-6.30|0.54
72585866|NCT00764660|144702923|SUPERIORITY_OR_OTHER||Difference in LS Means|-3.1||||0.51|TWO_SIDED|95.0|-12.35|6.15|||cLDA Model||cLDA Model with terms for treatment, pooled centers, assessment by treatment interaction.|||6.15|-12.35|0.51
72585867|NCT00764660|144702924|SUPERIORITY_OR_OTHER||Difference in LS Means|-9.17||||0.05|TWO_SIDED|95.0|-18.27|-0.07|||cLDA Model||cLDA Model with terms for treatment, pooled centers, assessment by treatment interaction.|||-0.07|-18.27|0.05
72585868|NCT03055338|144702938|SUPERIORITY||Difference in LSM|2.6||||0.44|TWO_SIDED|95.0|-4.0|9.2|||Longitudinal ANCOVA|Includes terms for treatment, baseline PANSS total score, age, duration of illness, week, and the interaction of week by treatment.|Difference in LSM = MK-8189 - Risperidone|||9.2|-4.0|0.440
72585869|NCT03055338|144702938|SUPERIORITY||Difference in LSM|-4.7||||0.074|TWO_SIDED|95.0|-9.8|0.5|||Longitudinal ANCOVA|Includes terms for treatment, baseline PANSS total score, age, duration of illness, week, and the interaction of week by treatment.|Difference in LSM = MK-8189 - Placebo|||0.5|-9.8|0.074
72585870|NCT03055338|144702938|SUPERIORITY||Difference in LSM|-7.3||||0.033|TWO_SIDED|95.0|-14.0|-0.6|||Longitudinal ANCOVA|Includes terms for treatment, baseline PANSS total score, age, duration of illness, week, and the interaction of week by treatment.|Difference in LSM = Risperidone - Placebo|||-0.6|-14.0|0.033
72585871|NCT03055338|144702939|OTHER||Difference in % versus Placebo|17.2|||||TWO_SIDED|95.0|3.0|30.8|||||Difference in % = MK-8918 - Placebo||Based on Miettinen \& Nurminen method.|30.8|3.0|
72585872|NCT03055338|144702940|OTHER||Difference in % versus Placebo|-1.2|||||TWO_SIDED|95.0|-9.6|7.0|||||Difference in % = MK-8918 - Placebo||Based on Miettinen \& Nurminen method.|7.0|-9.6|
72585873|NCT03055338|144702941|OTHER||Difference in LSM|0.2|||||TWO_SIDED|95.0|-0.2|0.6|||||Difference in LSM = MK-8189 - Risperidone|||0.6|-0.2|
72585874|NCT03055338|144702941|OTHER||Difference in LSM|-0.2|||||TWO_SIDED|95.0|-0.5|0.2|||||Difference in LSM = MK-8189 - Placebo|||0.2|-0.5|
72585875|NCT03055338|144702941|OTHER||Difference in LSM|-0.4|||||TWO_SIDED|95.0|-0.8|0.1|||||Difference in LSM = Risperidone - Placebo|||0.1|-0.8|
72585876|NCT02151851|144702946|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.899|||<|0.001|TWO_SIDED|95.0|2.382|6.382||Difference of CZP + MTX versus Placebo + MTX (and corresponding p-value) was estimated from a logistic regression model with factors for treatment and region.|Regression, Logistic|||||6.382|2.382|<0.001
72585877|NCT02151851|144702947|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|7.641|||<|0.001|TWO_SIDED|95.0|3.57|16.352||Difference of CZP + MTX versus Placebo + MTX (and corresponding p-value) was estimated from a logistic regression model with factors for treatment and region.|Regression, Logistic|||||16.352|3.570|<0.001
72585878|NCT02151851|144702948|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|7.248|||<|0.001|TWO_SIDED|95.0|2.209|23.786||Difference of CZP + MTX versus Placebo + MTX (and corresponding p-value) was estimated from a logistic regression model with factors for treatment and region.|Regression, Logistic|||||23.786|2.209|<0.001
72585879|NCT01540487|144702963|SUPERIORITY_OR_OTHER||adjusted gMean ratio|99.5|||||TWO_SIDED|90.0|94.7|104.5|||ANOVA|||||104.5|94.7|
72585880|NCT01540487|144702963|SUPERIORITY_OR_OTHER||adjusted gMean ratio|100.8|||||TWO_SIDED|90.0|95.1|106.8|||ANOVA|||||106.8|95.1|
72585881|NCT01540487|144702964|SUPERIORITY_OR_OTHER||adjusted gMean ratio|101.9|||||TWO_SIDED|90.0|95.4|109.0|||ANOVA|||||109.0|95.4|
72585882|NCT01540487|144702964|SUPERIORITY_OR_OTHER||adjusted gMean ratio|111.4|||||TWO_SIDED|90.0|100.4|123.5|||ANOVA|||||123.5|100.4|
72585883|NCT01540487|144702965|SUPERIORITY_OR_OTHER||adjusted gMean ratio|97.0|||||TWO_SIDED|90.0|90.6|103.8|||ANOVA|||||103.8|90.6|
72585884|NCT01540487|144702965|SUPERIORITY_OR_OTHER||adjusteg gMean ratio|103.0|||||TWO_SIDED|90.0|96.2|110.1|||ANOVA|||||110.1|96.2|
72585885|NCT01540487|144702966|SUPERIORITY_OR_OTHER||adjusted gMean ratio|94.6|||||TWO_SIDED|90.0|85.4|104.8|||ANOVA|||||104.8|85.4|
72585886|NCT01540487|144702966|SUPERIORITY_OR_OTHER||adjusted gMean ratio|102.5|||||TWO_SIDED|90.0|92.2|113.9|||ANOVA|||||113.9|92.2|
72585887|NCT01540487|144702967|SUPERIORITY_OR_OTHER||adjusted gMean ratio|110.1|||||TWO_SIDED|90.0|100.5|120.6|||ANOVA|||||120.6|100.5|
72585888|NCT01540487|144702967|SUPERIORITY_OR_OTHER||adjusted gMean ratio|89.3|||||TWO_SIDED|90.0|80.2|99.3|||ANOVA|||||99.3|80.2|
72585889|NCT01540487|144702968|SUPERIORITY_OR_OTHER||adjusted gMean ratio|98.0|||||TWO_SIDED|90.0|92.0|104.5|||ANOVA|||||104.5|92.0|
72585890|NCT01540487|144702968|SUPERIORITY_OR_OTHER||adjusted gMean ratio|102.8|||||TWO_SIDED|90.0|97.0|109.0|||ANOVA|||||109.0|97.0|
72585891|NCT01540487|144702969|SUPERIORITY_OR_OTHER||adjusted gMean ratio|99.5|||||TWO_SIDED|90.0|94.7|104.6|||ANOVA|||||104.6|94.7|
72585892|NCT01540487|144702969|SUPERIORITY_OR_OTHER||adjusted gMean ratio|100.8|||||TWO_SIDED|90.0|95.1|106.8|||ANOVA|||||106.8|95.1|
72585893|NCT01256164|144702970|NON_INFERIORITY_OR_EQUIVALENCE|With 90 subjects, randomized on a 2:1 ratio into the Fibrocaps plus gelatin sponge active arm or the gelatin sponge arm, and assuming a mean TTH of 3.5 minutes with a standard deviation of 2.5 minutes in the active arm and a mean TTH of 6 minutes in the control arm, this translates in a power of 99.4% at a two-sided significance level alpha of 5%, using a two-sample t-test.|||||<|0.001||95.0|||||t-test, 2 sided|||||||<0.001
72585894|NCT01256164|144702971|SUPERIORITY_OR_OTHER|||||||1||95.0|||||t-test, 2 sided|||||||1.00
72585895|NCT01256164|144702972|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Fisher Exact|||Intent-to-treat analysis||||<0.001
72585896|NCT01256164|144702973|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||Fisher Exact|||intent-to- treat analysis||||0.001
72585897|NCT01256164|144702974|SUPERIORITY_OR_OTHER|||||||0.003||95.0|||||Fisher Exact|||intent-to-treat analysis||||0.003
72585898|NCT03503370|144702975|SUPERIORITY||Hazard Ratio (HR)|0.83|||||TWO_SIDED|95.0|0.39|1.8|||||Hazard ratio from Cox Proportional Hazard comparing the chlorhexidine group to the placebo group.|||1.80|0.39|
72585899|NCT03503370|144702976|SUPERIORITY|||||||0.97|||||||Wilcoxon (Mann-Whitney)|||||||0.97
72585900|NCT03503370|144702977|SUPERIORITY||Hazard Ratio (HR)|0.78|||||TWO_SIDED|95.0|0.34|1.77|||||Hazard ratio from Cox Proportional Hazard comparing the chlorhexidine group to the placebo group.|||1.77|0.34|
72585901|NCT01598064|144702997|SUPERIORITY_OR_OTHER|||||||0.25|||||||Chi-squared|||||||0.25
72585902|NCT01436370|144703015|SUPERIORITY_OR_OTHER|||||||0.145|||||||Fisher Exact|||This is the comparison for the B/Brisbane/60/2008 strain.||||0.145
72585903|NCT01436370|144703015|SUPERIORITY_OR_OTHER|||||||0.145|||||||Fisher Exact|||This is the comparison for the A/Perth/16/2009 (A/H3N2) strain||||0.145
72585904|NCT01436370|144703015|SUPERIORITY_OR_OTHER|||||||0.999|||||||Fisher Exact|||This is the comparison for the A/California/7/2009 (A/H1N1) strain.||||0.999
72585905|NCT01436370|144703023|SUPERIORITY_OR_OTHER|||||||0.182|||||||Fisher Exact|||This is the comparison for the B/Wisconsin/1/2010 strain||||0.182
72585906|NCT01436370|144703023|SUPERIORITY_OR_OTHER|||||||0.5|||||||Fisher Exact|||This is the comparison for the A/Victoria/361/2011 (A/H3N2) strain.||||0.500
72585907|NCT01436370|144703023|SUPERIORITY_OR_OTHER|||||||0.087|||||||Fisher Exact|||This is the comparison for the A/California/7/2009 (A/H1N1) strain.||||0.087
72585908|NCT01436370|144703024|SUPERIORITY_OR_OTHER|||||||0.234|||||||Fisher Exact|||This is the comparison for the B/Brisbane/60/2008 strain at Day 7.||||0.234
72585909|NCT01436370|144703024|SUPERIORITY_OR_OTHER|||||||0.25|||||||Fisher Exact|||This is the comparison for the B/Brisbane/60/2008 strain at Day 180.||||0.250
72585910|NCT01436370|144703024|SUPERIORITY_OR_OTHER|||||||0.145|||||||Fisher Exact|||This is the comparison for the A/Perth/16/2009 (A/H3N2) strain at Day 7.||||0.145
72585911|NCT01436370|144703024|SUPERIORITY_OR_OTHER|||||||0.5|||||||Fisher Exact|||This is the comparison for the A/Perth/16/2009 (A/H3N2) strain at Day 180.||||0.500
72585912|NCT01436370|144703024|SUPERIORITY_OR_OTHER|||||||0.999|||||||Fisher Exact|||This is the comparison for the A/California/7/2009 (A/H1N1) strain at Day 7.||||0.999
72585913|NCT01436370|144703024|SUPERIORITY_OR_OTHER|||||||0.5|||||||Fisher Exact|||This is the comparison for the A/California/7/2009 (A/H1N1) strain at Day 180.||||0.500
72585914|NCT01436370|144703025|SUPERIORITY_OR_OTHER|||||||0.716|||||||Fisher Exact|||This is the comparison for the B/Wisconsin/1/2010 strain at Day 7.||||0.716
72585915|NCT01436370|144703025|SUPERIORITY_OR_OTHER|||||||0.999|||||||Fisher Exact|||This is the comparison for the B/Wisconsin/1/2010 strain at Day 180.||||0.999
72585916|NCT01436370|144703025|SUPERIORITY_OR_OTHER|||||||0.503|||||||Fisher Exact|||This is the comparison for the A/Victoria/361/2011 (A/H3N2) strain at Day 7.||||0.503
72585917|NCT01436370|144703025|SUPERIORITY_OR_OTHER|||||||0.475|||||||Fisher Exact|||This is the comparison for the A/Victoria/361/2011 (A/H3N2) strain at Day 180.||||0.475
72585918|NCT01436370|144703025|SUPERIORITY_OR_OTHER|||||||0.182|||||||Fisher Exact|||This is the comparison for the A/California/7/2009 (A/H1N1) strain at Day 7.||||0.182
72585919|NCT01436370|144703025|SUPERIORITY_OR_OTHER|||||||0.014|||||||Fisher Exact|||This is the comparison for the A/California/7/2009 (A/H1N1) strain at Day 180.||||0.014
72585920|NCT01436370|144703027|SUPERIORITY_OR_OTHER|||||||0.317|||||||McNemar|||This is the comparison for the B/Brisbane/60/2008 strain at Day 21.||||0.317
72585921|NCT01436370|144703027|SUPERIORITY_OR_OTHER|||||||0.564|||||||McNemar|||This is the comparison for the A/Perth/16/2009 (A/H3N2) strain at Day 21.||||0.564
72585922|NCT01436370|144703027|SUPERIORITY_OR_OTHER|||||||0.999|||||||McNemar|||This is the comparison for the A/California/7/2009 (A/H1N1) strain at Day 21.||||0.999
72413820|NCT01306162|144336830|NON_INFERIORITY_OR_EQUIVALENCE|Bioavailability|Geometric mean ratio TrtE: TrtA (%)|133.0|STANDARD_DEVIATION|23.0||0.6221|TWO_SIDED|90.0|94.0|190.0||p-value for geometric mean ratio being outside interval 80% to 125%|ANOVA|ANOVA with sequence, period and treatment as fixed effects and subject within sequence as random effect.|The standard deviation is actually the Geometric coefficient of variation|150mg DE + 400mg DR bid 2h later (TrtE) vs 150mg DE (TrtA)||190|94|0.6221
72413821|NCT01306162|144336831|NON_INFERIORITY_OR_EQUIVALENCE|Bioavailability|Geometric mean ratio TrtB: TrtA (%)|214.0|STANDARD_DEVIATION|20.7||1|TWO_SIDED|90.0|190.0|241.0||p-value for geometric mean ratio being outside interval 80% to 125%|ANOVA|ANOVA with sequence, period and treatment as fixed effects and subject within sequence as random effect.|The standard deviation is actually the Geometric coefficient of variation|150mg DE + 400mg DR (TrtB) vs 150mg DE (TrtA)||241|190|1.0000
72585923|NCT01436370|144703027|SUPERIORITY_OR_OTHER|||||||0.564|||||||McNemar|||This is the comparison for the B/Brisbane/60/2008 strain at Day 21.||||0.564
72585924|NCT01436370|144703027|SUPERIORITY_OR_OTHER|||||||0.999|||||||McNemar|||This is the comparison for the A/Perth/16/2009 (A/H3N2) strain at Day 21.||||0.999
72585925|NCT01436370|144703027|SUPERIORITY_OR_OTHER|||||||0.655|||||||McNemar|||This is the comparison for the A/California/7/2009 (A/H1N1) strain at Day 21.||||0.655
72585926|NCT01436370|144703028|SUPERIORITY_OR_OTHER|||||||0.18|||||||McNemar|||This is the comparison for the B/Wisconsin/1/2010 strain at Day 21.||||0.180
72585927|NCT01436370|144703028|SUPERIORITY_OR_OTHER|||||||0.763|||||||McNemar|||This is the comparison for the A/Victoria/361/2011 (A/H3N2) strain at Day 21.||||0.763
72585928|NCT01436370|144703028|SUPERIORITY_OR_OTHER|||||||0.096|||||||McNemar|||This is the comparison for the A/California/7/2009 (A/H1N1) strain at Day 21.||||0.096
72585929|NCT01436370|144703028|SUPERIORITY_OR_OTHER|||||||0.157|||||||McNemar|||This is the comparison for the B/Wisconsin/1/2010 strain at Day 21||||0.157
72585930|NCT01436370|144703028|SUPERIORITY_OR_OTHER|||||||0.705|||||||McNemar|||This is the comparison for the A/Victoria/361/2011 (A/H3N2) strain at Day 21.||||0.705
72585931|NCT01436370|144703028|SUPERIORITY_OR_OTHER|||||||0.132|||||||McNemar|||This is the comparison for the A/California/7/2009 (A/H1N1) strain at Day 21.||||0.132
72585932|NCT01754129|144703032|OTHER||||||<|0.001||||||Missing values were replaced using the Last Observation Carried Forward (LOCF) technique for data of questionnaires. Missing data at Visit 3 was replaced with the (non-missing) data recorded at Visit 2.|Paired t-test|||Mean change from baseline to Visit 3||||<0.001
72585933|NCT01754129|144703032|OTHER||||||<|0.001|||||||Paired t-test|||Change from baseline to Visit 2||||<0.001
72585934|NCT04229095|144703061|SUPERIORITY||Slope|-4.58|STANDARD_ERROR_OF_MEAN|1.82||0.007|ONE_SIDED|95.0||-1.01|||Mixed Models Analysis||The effect of the drug on lowering VAS was limited to individuals with impaired sleep at baseline (PSQI \> or = to 5).|Mixed effect model with directional hypothesis that drug reduces strength of craving (VAS). Principle predictors were drug condition, and baseline sleep disturbance (Pittsburgh Sleep Quality Index {PSQI} total score less than 5 or 5 and greater). Arms were combined for this analysis.||-1.01||.007
72585935|NCT04229095|144703063|SUPERIORITY||Mean Difference (Net)|-1.52|STANDARD_ERROR_OF_MEAN|0.54||0.0025|ONE_SIDED|95.0||-0.46|||Mixed Models Analysis|||Mixed effect model with directional hypothesis that drug reduces number of drinks per day. Principle predictors were drug condition and sex. Arms were combined for this analysis.||-0.46||.0025
72585936|NCT01780038|144703065|OTHER||||||||||||||||||Frequencies and percentages were used to determine this secondary outcome.|||
72585937|NCT01237041|144703066|SUPERIORITY|Univariate ANOVA||||||0.016||||||A priori threshold p\<0.05|ANOVA|Comparison of 3 dose-finding groups. Post-hoc comparisons between groups also done.||ANOVA to compare AUC of GH among groups||||.016
72585938|NCT01237041|144703067|SUPERIORITY|ANOVA of the 3 dose-finding groups. Data transformed using log(10) for analysis||||||0.043||||||A priori threshold for significance p\<0.05|ANOVA|||Analysis of FFA Area Under Curve in dose-finding studies. Data were log-transformed before analysis.||||.043
72585939|NCT01237041|144703068|SUPERIORITY|||||||0.543|||||||ANOVA|||ANOVA, 3 dose-finding groups||||0.543
72585940|NCT01237041|144703069|SUPERIORITY|||||||0.113|||||||ANOVA|||ANOVA, 2 groups, essentially an unpaired t-test.||||.113
72585941|NCT02877004|144703097|SUPERIORITY|||||||0.723|||||||ANCOVA|Data were analyzed using analysis of covariance with the baseline value included as the covariate.||||||0.723
72585942|NCT02877004|144703098|SUPERIORITY|||||||0.368|||||||ANCOVA|Data were analyzed using analysis of covariance with the baseline value included as the covariate||||||.368
72585943|NCT03150719|144703167|SUPERIORITY||Mean Difference|2.7|||||TWO_SIDED|95.0|1.0|4.4||||||||4.4|1.0|
72585944|NCT03150719|144703168|SUPERIORITY||Mean Difference|6.7|||||TWO_SIDED|95.0|2.5|10.9||||||||10.9|2.5|
72585945|NCT03150719|144703169|SUPERIORITY||Mean Difference|1.1|||||TWO_SIDED|95.0|-4.9|7.0||||||||7.0|-4.9|
72413822|NCT01306162|144336831|NON_INFERIORITY_OR_EQUIVALENCE|Bioavailability|Geometric mean ratio TrtC: TrtA (%)|132.0|STANDARD_DEVIATION|26.3||0.7223|TWO_SIDED|90.0|113.0|155.0||p-value for geometric mean ratio being outside interval 80% to 125%|ANOVA|ANOVA with sequence, period and treatment as fixed effects and subject within sequence as random effect.|The standard deviation is actually the Geometric coefficient of variation|150mg DE + 400mg DR 2h later (TrtC) vs 150mg DE (TrtA)||155|113|0.7223
72413823|NCT01306162|144336831|NON_INFERIORITY_OR_EQUIVALENCE|Bioavailability|Geometric mean ratio TrtD: TrtA (%)|258.0|STANDARD_DEVIATION|24.6||0.9993||90.0|182.0|365.0||p-value for geometric mean ratio being outside interval 80% to 125%|ANOVA|ANOVA with sequence, period and treatment as fixed effects and subject within sequence as random effect.|The standard deviation is actually the Geometric coefficient of variation|150mg DE + 400mg DR bid same time (TrtD) vs 150mg DE (TrtA)||365|182|0.9993
72413824|NCT01306162|144336831|NON_INFERIORITY_OR_EQUIVALENCE|Bioavailability|Geometric mean ratio TrtE: TrtA (%)|159.0|STANDARD_DEVIATION|21.5||0.8875|TWO_SIDED|90.0|114.0|222.0||p-value for geometric mean ratio being outside interval 80% to 125%|ANOVA|ANOVA with sequence, period and treatment as fixed effects and subject within sequence as random effect.|The standard deviation is actually the Geometric coefficient of variation|150mg DE + 400mg DR bid 2h later (TrtE) vs 150mg DE (TrtA)||222|114|0.8875
72585946|NCT01790984|144703172|OTHER||General linear mixed model|2.0|||<|0.05|TWO_SIDED|||||Outcome measures were analysed as dependent variables in a general linear mixed model. All outcome variables in the model analysed were part of an priori hypothesis, and for this reason were not subject to adjustment for multiple comparisons.|Mixed Models Analysis|Mixed model analysis was appropriate for testing differences between 2 Groups on 2 Diets (NAFLD, Control,high \& low sugar diets).|Details of our statistical approach are given below.|The sample size of the NAFDL \& Control groups was based on primary outcome measures for a trace-labelling study of VLDL kinetics (VLDL1 apo B \& TAG production rates). From the literature there was an 80% probability that our study will detect a difference in the production rates of VLDL1 apo B of 30% (α=39%), and 26% for VLDL1-TAG (α=33%). A paired comparison of two diets (5% level), gave sample sizes of n=15 for each group. Note: All reported P-values were calculated.|For outcome measures for which there were four samples from each participant (pre- and post-diets, for each period), the post-diet measurements were analysed as dependent variables in a general linear mixed model, with the following fixed categorical, non-random, explanatory effects: period, treatment (low and high sugar diet), period by treatment interaction (to detect carry-over effects), liver fat level (NAFLD and Control) and treatment by liver fat level interaction. The pre-diet measurements for each period, and bodyweights (pre- and post-diets) were included as covariates in the model, with participant as a model random effect. For outcome measures for which there were two samples for each participant (post-diets; end of each dietary intervention period only), each measurement for the combined groups (NAFLD and controls), for the 2-period cross-over, were analysed in a general linear mixed model with the same fixed categorical effects and bodyweights as covariates.|||<0.05
72585947|NCT01790984|144703173|OTHER||General linear mixed model|11.0|||<|0.05|TWO_SIDED|||||Outcome measures were analysed as dependent variables in a general linear mixed model. All outcome variables in the model analysed were part of an priori hypothesis, and for this reason were not subject to adjustment for multiple comparisons.|Mixed Models Analysis|Mixed model analysis was appropriate for testing the impact of 'Diet' (high and low sugar) and Group (NAFLD and Control) status on outcome variables.|Details of our statistical analyses are given below.|The sample size for NAFLD \& Control groups was based on primary outcome measures for a trace-labelling study of VLDL kinetics (VLDL1 apo B and triacylglycerol production rates). From the literature there was an 80% probability that our study will detect a difference in the production rates of VLDL1 apo B of 30% (α=39%), and 26% for VLDL1-TG (α=33%). A paired comparison of two diets (5% level) produced sample sizes of n=15 for each group. Note: All reported P-values were calculated.|For outcome measures for which there were four samples from each participant (pre- and post-diets, for each period), the post-diet measurements were analysed as dependent variables in a general linear mixed model, with the following fixed categorical, non-random, explanatory effects: period, treatment (low and high sugar diet), period by treatment interaction (to detect carry-over effects), liver fat level (NAFLD and Control) and treatment by liver fat level interaction. The pre-diet measurements for each period, and bodyweights (pre- and post-diets) were included as covariates in the model, with participant as a model random effect. For outcome measures for which there were two samples for each participant (post-diets; end of each dietary intervention period only), each measurement for the combined groups (NAFLD and controls), for the 2-period cross-over, were analysed in a general linear mixed model with the same fixed categorical effects and bodyweights as covariates.|||<0.05
72585948|NCT01790984|144703174|OTHER||General linear mixed model|110.0|||<|0.05|TWO_SIDED|||||Outcome measures were analysed as dependent variables in a general linear mixed model. All outcome variables in the model analysed were part of an priori hypothesis, and for this reason were not subject to adjustment for multiple comparisons.|Mixed Models Analysis|Mixed model analysis was appropriate for testing the impact of 'Diet' (high and low sugar) and Group (NAFLD and Control) status on outcome variables.|Details of our statistical analyses are given below.|The sample size of the NAFDL \& Control groups was based on primary outcome measures for a trace-labelling study of VLDL kinetics (VLDL1 apo B \& TAG production rates). From the literature there was an 80% probability that our study will detect a difference in the production rates of VLDL1 apo B of 30% (α=39%), and 26% for VLDL1-TG (α=33%). A paired comparison of two diets (5% level), gave sample sizes of n=15 for each group. Note: All reported P-values were calculated.|For outcome measures for which there were four samples from each participant (pre- and post-diets, for each period), the post-diet measurements were analysed as dependent variables in a general linear mixed model, with the following fixed categorical, non-random, explanatory effects: period, treatment (low and high sugar diet), period by treatment interaction (to detect carry-over effects), liver fat level (NAFLD and Control) and treatment by liver fat level interaction. The pre-diet measurements for each period, and bodyweights (pre- and post-diets) were included as covariates in the model, with participant as a model random effect. For outcome measures for which there were two samples for each participant (post-diets; end of each dietary intervention period only), each measurement for the combined groups (NAFLD and controls), for the 2-period cross-over, were analysed in a general linear mixed model with the same fixed categorical effects and bodyweights as covariates.|||<0.05
72585949|NCT01790984|144703175|OTHER||General linear mixed model|0.26|||<|0.05|TWO_SIDED|||||Outcome measures were analysed as dependent variables in a general linear mixed model. All outcome variables in the model analysed were part of an priori hypothesis, and for this reason were not subject to adjustment for multiple comparisons.|Mixed Models Analysis|Mixed model analysis was appropriate for testing the impact of 'Diet' (high and low sugar) and Group (NAFLD and Control) status on outcome variables.|Details of our statistical approach are given below.|The sample size of the NAFDL \& Control groups was based on primary outcome measures for a trace-labelling study of VLDL kinetics (VLDL1 apo B \& TAG production rates). From the literature there was an 80% probability that our study will detect a difference in the production rates of VLDL1 apo B of 30% (α=39%), and 26% for VLDL1-TG (α=33%). A paired comparison of two diets (5% level), gave sample sizes of n=15 for each group. Note: All reported P-values were calculated.|For outcome measures for which there were four samples from each participant (pre- and post-diets, for each period), the post-diet measurements were analysed as dependent variables in a general linear mixed model, with the following fixed categorical, non-random, explanatory effects: period, treatment (low and high sugar diet), period by treatment interaction (to detect carry-over effects), liver fat level (NAFLD and Control) and treatment by liver fat level interaction. The pre-diet measurements for each period, and bodyweights (pre- and post-diets) were included as covariates in the model, with participant as a model random effect. For outcome measures for which there were two samples for each participant (post-diets; end of each dietary intervention period only), each measurement for the combined groups (NAFLD and controls), for the 2-period cross-over, were analysed in a general linear mixed model with the same fixed categorical effects and bodyweights as covariates.|||<0.05
72585950|NCT01790984|144703176|OTHER||General linear mixed model|10.0|||>|0.05|TWO_SIDED|||||Outcome measures were analysed as dependent variables in a general linear mixed model. All outcome variables in the model analysed were part of an priori hypothesis, and for this reason were not subject to adjustment for multiple comparisons.|Mixed Models Analysis|Mixed model analysis was appropriate for testing the impact of 'Diet' (high and low sugar) and Group (NAFLD and Control) status on outcome variables|Details of our statistical analyses are described below.|The sample size of the NAFDL \& Control groups was based on primary outcome measures for a trace-labelling study of VLDL kinetics (VLDL1 apo B \& TAG production rates). From the literature there was an 80% probability that our study will detect a difference in the production rates of VLDL1 apo B of 30% (α=39%), and 26% for VLDL1-TG (α=33%). A paired comparison of two diets (5% level), gave sample sizes of n=15 for each group. Note: All reported P-values were calculated.|For outcome measures for which there were four samples from each participant (pre- and post-diets, for each period), the post-diet measurements were analysed as dependent variables in a general linear mixed model, with the following fixed categorical, non-random, explanatory effects: period, treatment (low and high sugar diet), period by treatment interaction (to detect carry-over effects), liver fat level (NAFLD and Control) and treatment by liver fat level interaction. The pre-diet measurements for each period, and bodyweights (pre- and post-diets) were included as covariates in the model, with participant as a model random effect. For outcome measures for which there were two samples for each participant (post-diets; end of each dietary intervention period only), each measurement for the combined groups (NAFLD and controls), for the 2-period cross-over, were analysed in a general linear mixed model with the same fixed categorical effects and bodyweights as covariates.|||>0.05
72585951|NCT01790984|144703177|OTHER||General linear mixed model|0.28|||<|0.05|TWO_SIDED|||||Outcome measures were analysed as dependent variables in a general linear mixed model. All outcome variables in the model analysed were part of an priori hypothesis, and for this reason were not subject to adjustment for multiple comparisons.|Mixed Models Analysis|Mixed model analysis was appropriate for testing the impact of 'Diet' (high and low sugar) and Group (NAFLD and Control) status on outcome variables.|Details of our statistical analyses are given below.|The sample size of the NAFDL \& Control groups was based on primary outcome measures for a trace-labelling study of VLDL kinetics (VLDL1 apo B \& TAG production rates). From the literature there was an 80% probability that our study will detect a difference in the production rates of VLDL1 apo B of 30% (α=39%), and 26% for VLDL1-TG (α=33%). A paired comparison of two diets (5% level), gave sample sizes of n=15 for each group. Note: All reported P-values were calculated.|For outcome measures for which there were four samples from each participant (pre- and post-diets, for each period), the post-diet measurements were analysed as dependent variables in a general linear mixed model, with the following fixed categorical, non-random, explanatory effects: period, treatment (low and high sugar diet), period by treatment interaction (to detect carry-over effects), liver fat level (NAFLD and Control) and treatment by liver fat level interaction. The pre-diet measurements for each period, and bodyweights (pre- and post-diets) were included as covariates in the model, with participant as a model random effect. For outcome measures for which there were two samples for each participant (post-diets; end of each dietary intervention period only), each measurement for the combined groups (NAFLD and controls), for the 2-period cross-over, were analysed in a general linear mixed model with the same fixed categorical effects and bodyweights as covariates.|||<0.05
72585952|NCT01691560|144703214|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.09||||0.4553|TWO_SIDED|95.0|-0.14|0.32|||ANCOVA|From ANCOVA model with treatment and baseline included as covariate.|Difference is First named treatment minus Second named treatment that negative difference implies the mean of the second named treatment is larger than that of the first named treatment.|Null hypothesis considered change from baseline to be same for treatments in comparison.||0.32|-0.14|0.4553
72585953|NCT01691560|144703214|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.07||||0.5689|TWO_SIDED|95.0|-0.16|0.3|||ANCOVA|From ANCOVA model with treatment and baseline included as covariate.|Difference is First named treatment minus Second named treatment that negative difference implies the mean of the second named treatment is larger than that of the first named treatment.|Null hypothesis considered change from baseline to be same for treatments in comparison.||0.30|-0.16|0.5689
72585954|NCT01691560|144703214|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.04||||0.7517|TWO_SIDED|95.0|-0.2|0.27|||ANCOVA|From ANCOVA model with treatment and baseline included as covariate.|Difference is First named treatment minus Second named treatment that negative difference implies the mean of the second named treatment is larger than that of the first named treatment.|Null hypothesis considered change from baseline to be same for treatments in comparison.||0.27|-0.20|0.7517
72585955|NCT01691560|144703214|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.02||||0.8549|TWO_SIDED|95.0|-0.21|0.25|||ANCOVA|From ANCOVA model with treatment and baseline included as covariate.|Difference is First named treatment minus Second named treatment that negative difference implies the mean of the second named treatment is larger than that of the first named treatment.|Null hypothesis considered change from baseline to be same for treatments in comparison.||0.25|-0.21|0.8549
72585956|NCT01691560|144703214|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.05||||0.6685|TWO_SIDED|95.0|-0.18|0.29|||ANCOVA|From ANCOVA model with treatment and baseline included as covariate.|Difference is First named treatment minus Second named treatment that negative difference implies the mean of the second named treatment is larger than that of the first named treatment.|Null hypothesis considered change from baseline to be same for treatments in comparison.||0.29|-0.18|0.6685
72585957|NCT01691560|144703214|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.03||||0.8031|TWO_SIDED|95.0|-0.26|0.2|||ANCOVA||Difference is First named treatment minus Second named treatment that negative difference implies the mean of the second named treatment is larger than that of the first named treatment.|Null hypothesis considered change from baseline to be same for treatments in comparison.||0.20|-0.26|0.8031
72413825|NCT01306162|144336832|NON_INFERIORITY_OR_EQUIVALENCE|Bioavailability|Geometric mean ratio TrtB: TrtA (%)|180.0|STANDARD_DEVIATION|24.6||0.9998|TWO_SIDED|90.0|156.0|207.0||p-value for geometric mean ratio being outside interval 80% to 125%|ANOVA|ANOVA with sequence, period and treatment as fixed effects and subject within sequence as random effect.|The standard deviation is actually the Geometric coefficient of variation|150mg DE + 400mg DR (TrtB) vs 150mg DE (TrtA)||207|156|0.9998
72413826|NCT01306162|144336832|NON_INFERIORITY_OR_EQUIVALENCE|Bioavailability|Geometric mean ratio TrtC: TrtA (%)|114.0|STANDARD_DEVIATION|29.4||0.1866|TWO_SIDED|90.0|95.0|136.0||p-value for geometric mean ratio being outside interval 80% to 125%|ANOVA|ANOVA with sequence, period and treatment as fixed effects and subject within sequence as random effect.|The standard deviation is actually the Geometric coefficient of variation|150mg DE + 400mg DR 2h later (TrtC) vs 150mg DE (TrtA)||136|95|0.1866
72413827|NCT01306162|144336832|NON_INFERIORITY_OR_EQUIVALENCE|Bioavailability|Geometric mean ratio TrtD: TrtA (%)|234.0|STANDARD_DEVIATION|26.7||0.9958||90.0|160.0|340.0||p-value for geometric mean ratio being outside interval 80% to 125%|ANOVA|ANOVA with sequence, period and treatment as fixed effects and subject within sequence as random effect.|The standard deviation is actually the Geometric coefficient of variation|150mg DE + 400mg DR bid same time (TrtD) vs 150mg DE (TrtA)||340|160|0.9958
72585958|NCT01691560|144703215|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.0467|TWO_SIDED|95.0|0.0|5.0|||Wilcoxon (Mann-Whitney)|Hodges-Lehmann Wilcoxon non-parametric test|Difference is First named treatment minus Second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered change from baseline to be same for treatments in comparison.||5|0|0.0467
72585959|NCT01691560|144703215|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.1133|TWO_SIDED|95.0|0.0|5.0|||Wilcoxon (Mann-Whitney)|Hodges-Lehmann Wilcoxon non-parametric test.|Difference is First named treatment minus Second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered change from baseline to be same for treatments in comparison.||5|0|0.1133
72585960|NCT01691560|144703215|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.2579||95.0|0.0|5.0|||Wilcoxon (Mann-Whitney)|Hodges-Lehmann Wilcoxon non-parametric test|Difference is First named treatment minus Second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered change from baseline to be same for treatments in comparison.||5|0|0.2579
72585961|NCT01691560|144703215|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.6149|TWO_SIDED|95.0|0.0|0.0|||Wilcoxon (Mann-Whitney)|Hodges-Lehmann Wilcoxon non-parametric test.|Difference is First named treatment minus Second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered change from baseline to be same for treatments in comparison.||0|0|0.6149
72585962|NCT01691560|144703215|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.3259|TWO_SIDED|95.0|0.0|5.0|||Wilcoxon (Mann-Whitney)|Hodges-Lehmann Wilcoxon non-parametric test|Difference is First named treatment minus Second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered change from baseline to be same for treatments in comparison.||5|0|0.3259
72585963|NCT01691560|144703215|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.5721|TWO_SIDED|95.0|0.0|0.0|||Wilcoxon (Mann-Whitney)|Hodges-Lehmann Wilcoxon non-parametric test|Difference is First named treatment minus Second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered change from baseline to be same for treatments in comparison.||0|0|0.5721
72585964|NCT01691560|144703216|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.36||||0.0292|TWO_SIDED|95.0|0.04|0.69|||ANCOVA|From ANCOVA model with treatment and baseline included as covariate.|Difference is First named treatment minus Second named treatment that negative difference implies the mean of the second named treatment is larger than that of the first named treatment.|Null hypothesis considered change from baseline to be same for treatments in comparison.||0.69|0.04|0.0292
72585965|NCT01691560|144703216|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.12||||0.4484|TWO_SIDED|95.0|-0.44|0.2|||ANCOVA|From ANCOVA model with treatment and baseline included as covariate.|Difference is First named treatment minus Second named treatment that negative difference implies the mean of the second named treatment is larger than that of the first named treatment.|Null hypothesis considered change from baseline to be same for treatments in comparison.||0.20|-0.44|0.4484
72585966|NCT01691560|144703216|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.12||||0.4537|TWO_SIDED|95.0|-0.45|0.2|||ANCOVA|From ANCOVA model with treatment and baseline included as covariate.|Difference is First named treatment minus Second named treatment that negative difference implies the mean of the second named treatment is larger than that of the first named treatment.|Null hypothesis considered change from baseline to be same for treatments in comparison.||0.20|-0.45|0.4537
72585967|NCT01691560|144703216|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.49||||0.0037|TWO_SIDED|95.0|0.16|0.81|||ANCOVA|From ANCOVA model with treatment and baseline included as covariate.|Difference is First named treatment minus Second named treatment that negative difference implies the mean of the second named treatment is larger than that of the first named treatment.|Null hypothesis considered change from baseline to be same for treatments in comparison.||0.81|0.16|0.0037
72585968|NCT01691560|144703216|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.48||||0.004|TWO_SIDED|95.0|0.16|0.81|||ANCOVA|From ANCOVA model with treatment and baseline included as covariate.|Treatment as fixed factor, baseline Schiff score as covariate. Difference is First named treatment minus Second named treatment that negative difference implies the mean of the second named treatment is larger than that of the first named treatment.|Null hypothesis considered change from baseline to be same for treatments in comparison.||0.81|0.16|0.0040
72585969|NCT01691560|144703216|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.0||||0.9974|TWO_SIDED|95.0|-0.32|0.32|||ANCOVA|From ANCOVA model with treatment and baseline included as covariate.|Difference is First named treatment minus Second named treatment that negative difference implies the mean of the second named treatment is larger than that of the first named treatment.|Null hypothesis considered change from baseline to be same for treatments in comparison.||0.32|-0.32|0.9974
72585970|NCT01691560|144703217|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.8861|TWO_SIDED|95.0|-5.0|5.0|||Wilcoxon (Mann-Whitney)|Hodges-Lehmann Wilcoxon non-parametric test|Difference is First named treatment minus Second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered change from baseline to be same for treatments in comparison.||5|-5|0.8861
72585971|NCT01691560|144703217|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.0641|TWO_SIDED|95.0|0.0|5.0|||Wilcoxon (Mann-Whitney)|Hodges-Lehmann Wilcoxon non-parametric test|Difference is First named treatment minus Second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered change from baseline to be same for treatments in comparison.||5|0|0.0641
72585972|NCT01691560|144703217|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.1831||95.0|0.0|5.0|||Wilcoxon (Mann-Whitney)|Hodges-Lehmann Wilcoxon non-parametric test|Difference is First named treatment minus Second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered change from baseline to be same for treatments in comparison.||5|0|0.1831
72585973|NCT01691560|144703217|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.0871|TWO_SIDED|95.0|-10.0|0.0|||Wilcoxon (Mann-Whitney)|Hodges-Lehmann Wilcoxon non-parametric test|Difference is First named treatment minus Second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered change from baseline to be same for treatments in comparison.||0|-10|0.0871
72585974|NCT01691560|144703217|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.169|TWO_SIDED|95.0|-10.0|0.0|||Wilcoxon (Mann-Whitney)|Hodges-Lehmann Wilcoxon non-parametric test|Difference is First named treatment minus Second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered change from baseline to be same for treatments in comparison.||0|-10|0.1690
72585975|NCT01691560|144703217|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.3829|TWO_SIDED|95.0|-5.0|0.0|||Wilcoxon (Mann-Whitney)|Hodges-Lehmann Wilcoxon non-parametric test|Difference is First named treatment minus Second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered change from baseline to be same for treatments in comparison.||0|-5|0.3829
72585976|NCT01691560|144703218|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.03||||0.9421|TWO_SIDED|95.0|-0.74|0.8|||ANCOVA|ANCOVA with treatment and Schiff stratification as factors and baseline VRS as covariate.|Difference is first named treatment minus second named treatment that a negative difference implies the mean of second named treatment is larger than that of the first named treatment.|Null hypothesis considered change from baseline to be same for treatments in comparison.||0.80|-0.74|0.9421
72585977|NCT01691560|144703218|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.15||||0.6918|TWO_SIDED|95.0|-0.9|0.6|||ANCOVA|ANCOVA with treatment and Schiff stratification as factors and baseline VRS as covariate.|Difference is first named treatment minus second named treatment that a negative difference implies the mean of second named treatment is larger than that of the first named treatment.|Null hypothesis considered change from baseline to be same for treatments in comparison.||0.60|-0.90|0.6918
72585978|NCT01691560|144703218|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.13||||0.7421|TWO_SIDED|95.0|-0.63|0.88|||ANCOVA|From ANCOVA with treatment and Schiff stratification as factors and baseline VRS as covariate.|Difference is first named treatment minus second named treatment that a negative difference implies the mean of second named treatment is larger than that of the first named treatment.|Null hypothesis considered change from baseline to be same for treatments in comparison.||0.88|-0.63|0.7421
72585979|NCT01691560|144703218|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.18||||0.6433|TWO_SIDED|95.0|-0.58|0.94|||ANCOVA|From ANCOVA with treatment and Schiff stratification as factors and baseline VRS as covariate.|Difference is first named treatment minus second named treatment that a negative difference implies the mean of second named treatment is larger than that of the first named treatment.|Null hypothesis considered change from baseline to be same for treatments in comparison.||0.94|-0.58|0.6433
72585980|NCT01691560|144703218|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.1||||0.801|TWO_SIDED|95.0|-0.86|0.67|||ANCOVA|From ANCOVA with treatment and Schiff stratification as factors and baseline VRS as covariate.|Difference is first named treatment minus second named treatment that a negative difference implies the mean of second named treatment is larger than that of the first named treatment.|Null hypothesis considered change from baseline to be same for treatments in comparison.||0.67|-0.86|0.8010
72585981|NCT01691560|144703218|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.28||||0.4692|TWO_SIDED|95.0|-0.48|1.03|||ANCOVA|From ANCOVA with treatment and Schiff stratification as factors and baseline VRS as covariate.|Difference is first named treatment minus second named treatment that a negative difference implies the mean of second named treatment is larger than that of the first named treatment.|Null hypothesis considered change from baseline to be same for treatments in comparison.||1.03|-0.48|0.4692
72585982|NCT01691560|144703219|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.31||||0.4797|TWO_SIDED|95.0|-0.55|1.16|||ANCOVA|From ANCOVA with treatment and Schiff stratification as factors and baseline VRS as covariate.|Difference is first named treatment minus second named treatment that a negative difference implies the mean of second named treatment is larger than that of the first named treatment.|Null hypothesis considered change from baseline to be same for treatments in comparison.||1.16|-0.55|0.4797
72585983|NCT01691560|144703219|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.54||||0.2023|TWO_SIDED|95.0|-1.37|0.29|||ANCOVA|From ANCOVA with treatment and Schiff stratification as factors and baseline VRS as covariate.|Difference is first named treatment minus second named treatment that a negative difference implies the mean of second named treatment is larger than that of the first named treatment.|Null hypothesis considered change from baseline to be same for treatments in comparison.||0.29|-1.37|0.2023
72585984|NCT01691560|144703219|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.45||||0.2917|TWO_SIDED|95.0|-1.29|0.39|||ANCOVA|From ANCOVA with treatment and Schiff stratification as factors and baseline VRS as covariate.|Difference is first named treatment minus second named treatment that a negative difference implies the mean of second named treatment is larger than that of the first named treatment.|Null hypothesis considered change from baseline to be same for treatments in comparison.||0.39|-1.29|0.2917
72585985|NCT01691560|144703219|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.85||||0.0503|TWO_SIDED|95.0|0.0|1.69|||ANCOVA|From ANCOVA with treatment and Schiff stratification as factors and baseline VRS as covariate.|Difference is first named treatment minus second named treatment that a negative difference implies the mean of second named treatment is larger than that of the first named treatment.|Null hypothesis considered change from baseline to be same for treatments in comparison.||1.69|0.00|0.0503
72585986|NCT01691560|144703219|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.76||||0.0811|TWO_SIDED|95.0|-0.09|1.61|||ANCOVA|From ANCOVA with treatment and Schiff stratification as factors and baseline VRS as covariate.|Difference is first named treatment minus second named treatment that a negative difference implies the mean of second named treatment is larger than that of the first named treatment.|Null hypothesis considered change from baseline to be same for treatments in comparison.||1.61|-0.09|0.0811
72585987|NCT01691560|144703219|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.09||||0.8322|TWO_SIDED|95.0|-0.75|0.93|||ANCOVA|From ANCOVA with treatment and Schiff stratification as factors and baseline VRS as covariate.|Difference is first named treatment minus second named treatment that a negative difference implies the mean of second named treatment is larger than that of the first named treatment.|Null hypothesis considered change from baseline to be same for treatments in comparison.||0.93|-0.75|0.8322
72585988|NCT01081769|144703246|SUPERIORITY_OR_OTHER|||||||0.0191|||||||Log Rank|||||||0.0191
72585989|NCT01081769|144703260|SUPERIORITY_OR_OTHER|||||||0.0323|||||||Fisher Exact|||||||0.0323
72585990|NCT00507455|144703261|NON_INFERIORITY_OR_EQUIVALENCE|If the upper limit of the 2-sided 95% confidence interval (CI) for the difference from placebo was less than 15 cmH2O for PdetQmax, then the treatment is non-inferior to the placebo in PdetQmax.|LS Mean Difference|-6.15|||||TWO_SIDED|95.0|-14.67|2.37|||||Least squares (LS) means were analyzed using analysis of covariance (ANCOVA) with the site and treatment group as the factors and the baseline value as the covariate.|A hierarchical step-down procedure was used to control for multiplicity. The comparison between solifenacin 6 mg + tamsulosin 0.4 mg and placebo was conducted first. If non-inferiority was demonstrated, solifenacin 9 mg + tamsulosin 0.4 mg was then compared to placebo. If the first comparison did not demonstrate non-inferiority, no further testing was performed. This procedure maintained the overall type I error of 1-sided 2.5%.||2.37|-14.67|
72585991|NCT00507455|144703261|NON_INFERIORITY_OR_EQUIVALENCE|If the upper limit of the 2-sided 95% confidence interval (CI) for the difference from placebo was less than 15 cmH2O for PdetQmax, then the treatment is non-inferior to the placebo in PdetQmax.|LS Mean Difference|-5.0|||||TWO_SIDED|95.0|-13.85|3.84|||||Least squares (LS) means were analyzed using analysis of covariance (ANCOVA) with the site and treatment group as the factors and the baseline value as the covariate.|A hierarchical step-down procedure was used to control for multiplicity. The comparison between solifenacin 6 mg + tamsulosin 0.4 mg and placebo was conducted first. If non-inferiority was demonstrated, solifenacin 9 mg + tamsulosin 0.4 mg was then compared to placebo. If the first comparison did not demonstrate non-inferiority, no further testing was performed. This procedure maintained the overall type I error of 1-sided 2.5%.||3.84|-13.85|
72585992|NCT00507455|144703263|NON_INFERIORITY_OR_EQUIVALENCE|If the lower limit of the 2-sided 95% confidence interval (CI) for the difference from placebo was greater than -3 mL/sec for Qmax, then the treatment is non-inferior to the placebo in Qmax.|LS Mean Difference|1.67|||||TWO_SIDED|95.0|0.5|2.85|||||Least squares (LS) means were analyzed using analysis of covariance (ANCOVA) with the site and treatment group as the factors and the baseline value as the covariate.|A hierarchical step-down procedure was used to control for multiplicity. The comparison between solifenacin 6 mg + tamsulosin 0.4 mg and placebo was conducted first. If non-inferiority was demonstrated, solifenacin 9 mg + tamsulosin 0.4 mg was then compared to placebo. If the first comparison did not demonstrate non-inferiority, no further testing was performed. This procedure maintained the overall type I error of 1-sided 2.5%.||2.85|0.50|
72585993|NCT00507455|144703263|NON_INFERIORITY_OR_EQUIVALENCE|If the lower limit of the 2-sided 95% confidence interval (CI) for the difference from placebo was greater than -3 mL/sec for Qmax, then the treatment is non-inferior to the placebo in Qmax.|LS Mean Difference|2.18|||||TWO_SIDED|95.0|0.98|3.37|||||Least squares (LS) means were analyzed using analysis of covariance (ANCOVA) with the site and treatment group as the factors and the baseline value as the covariate.|A hierarchical step-down procedure was used to control for multiplicity. The comparison between solifenacin 6 mg + tamsulosin 0.4 mg and placebo was conducted first. If non-inferiority was demonstrated, solifenacin 9 mg + tamsulosin 0.4 mg was then compared to placebo. If the first comparison did not demonstrate non-inferiority, no further testing was performed. This procedure maintained the overall type I error of 1-sided 2.5%.||3.37|0.98|
72585994|NCT01737710|144703284|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.8||||0.082|TWO_SIDED|95.0|0.92|3.55||Null hypothesis: no difference in the percent of participants that were seroprotected against influenza B at Day 28 between the two groups.|Fisher Exact|||||3.55|0.92|0.082
72585995|NCT01737710|144703285|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.83||||0.801|TWO_SIDED|95.0|0.26|2.56||Null hypothesis: no difference in the percent of participants that were seroprotected against influenza H1N1 at Day 28 between the two groups|Fisher Exact|||||2.56|0.26|0.801
72585996|NCT01737710|144703286|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.02||||0.177|TWO_SIDED|95.0|0.75|5.71||Null hypothesis: no difference in the percentage of participants that were seroprotected against influenza H3N2 at Day 28 between the two groups.|Fisher Exact|||||5.71|0.75|0.177
72585997|NCT01737710|144703287|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.25||||0.092|TWO_SIDED|95.0|0.96|1.61||Null hypothesis: the fold differences in geometric mean titers against influenza B are not different between the two groups.|ANCOVA|||||1.61|0.96|0.092
72585998|NCT01737710|144703288|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.59||||0.103|TWO_SIDED|95.0|0.32|1.11||Null hypothesis: the fold differences in geometric mean titers against influenza H1N1 are not different between the two groups.|ANCOVA|||||1.11|0.32|0.103
72585999|NCT01737710|144703289|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.04||||0.895|TWO_SIDED|95.0|0.6|1.8||Null hypothesis: the fold differences in geometric mean titers against influenza H3N2 are not different between the two groups.|ANCOVA|||||1.80|0.60|0.895
72586000|NCT01737710|144703290|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.03|||>|0.999|TWO_SIDED|95.0|0.54|1.97||Null hypothesis: no difference in the percentage of participants that were seroprotected against influenza B at Day 28 between the two groups.|Fisher Exact|||||1.97|0.54|>0.999
72586001|NCT01737710|144703291|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.43||||0.253|TWO_SIDED|95.0|0.09|1.63||Null hypothesis: no difference in the percentage of participants that were seroprotected against influenza H1N1 at Day 28 between the two groups.|Fisher Exact|||||1.63|0.09|0.253
72586002|NCT01737710|144703292|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.36||||0.218|TWO_SIDED|95.0|0.06|1.58||Null hypothesis: no difference in the percentage of participants that were seroprotected against influenza H3N2 at Day 28 between the two groups.|Fisher Exact|||||1.58|0.06|0.218
72586003|NCT01737710|144703293|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.57||||0.14|TWO_SIDED|95.0|0.84|2.94||Null hypothesis: no difference in the percentage of participants that were seroconverted against influenza B at Day 28 between the two groups.|Fisher Exact|||||2.94|0.84|0.140
72586004|NCT01737710|144703294|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.81||||0.791|TWO_SIDED|95.0|0.24|2.65||Null hypothesis: no difference in the percentage of participants that were seroconverted against influenza H1N1 at Day 28 between the two groups.|Fisher Exact|||||2.65|0.24|0.791
72586005|NCT01737710|144703295|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.17||||0.833|TWO_SIDED|95.0|0.47|2.92||Null hypothesis: no difference in the percentage of participants that were seroconverted against influenza H3N2 at Day 28 between the two groups.|Fisher Exact|||||2.92|0.47|0.833
72586006|NCT01737710|144703296|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.75||||0.378|TWO_SIDED|95.0|0.4|1.38||Null hypothesis: no difference in the percentage of participants that were seroconverted against influenza B at Day 28 between the two groups.|Fisher Exact|||||1.38|0.40|0.378
72586007|NCT01737710|144703297|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.77||||0.783|TWO_SIDED|95.0|0.21|2.62||Null hypothesis: no difference in the percentage of participants that were seroconverted against influenza H1N1 at Day 28 between the two groups.|Fisher Exact|||||2.62|0.21|0.783
72586008|NCT01737710|144703298|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.45||||0.143|TWO_SIDED|95.0|0.13|1.39|||Fisher Exact|Null hypothesis: no difference in the percentage of participants that were seroconverted against influenza H3N2 at Day 28 between the two groups.||||1.39|0.13|0.143
72586009|NCT00942890|144703328|SUPERIORITY_OR_OTHER||Slope|0.9|STANDARD_ERROR_OF_MEAN|0.24|<|0.05|TWO_SIDED||||||Mixed Models Analysis|||||||<0.05
72586010|NCT00942890|144703334|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Regression, Linear|||||||<0.05
72586011|NCT00812981|144703358|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was defined as the upper limit of the two-sided 95% confidence interval (CI) for the GMT ratio of HI antibodies against the A/Indonesia/05/2005 strain between the two groups (1562902A CP Group over 1562902A NP Group), being below (\<) 2.0.|Adjusted GMT ratio|0.84|||||TWO_SIDED|95.0|0.71|0.99|||ANCOVA|||Difference in adjusted GMT ratio for HI antibodies: To demonstrate that the NP 1562902A vaccine was non-inferior to the CP 1562902A vaccine, with respect to HI antibody GMT against the A/Indonesia/05/2005 strain, 42 days following vaccination.||0.99|0.71|
72586012|NCT04922255|144703383|SUPERIORITY|||||||0.04|||||||ANOVA|||||||0.04
72586013|NCT04922255|144703384|SUPERIORITY|||||||0.5|||||||Kruskal-Wallis|||||||0.50
72586014|NCT04922255|144703385|SUPERIORITY|||||||0.3|||||||ANOVA|||||||0.30
72586015|NCT04922255|144703386|SUPERIORITY|||||||0.7|||||||Chi-squared|||||||0.70
72586016|NCT04922255|144703387|SUPERIORITY|||||||0.01|||||||Chi-squared|||||||0.01
72586017|NCT02677922|144703390|SUPERIORITY||Odds Ratio (OR)|4.86||||0.0003|TWO_SIDED|95.0|1.99|11.85|||Chi-squared|||||11.85|1.99|0.0003
72586018|NCT02677922|144703393|SUPERIORITY||Cox Proportional Hazard|0.59||||0.1083|TWO_SIDED|95.0|0.3|1.13|||Log Rank|||||1.13|0.30|0.1083
72586019|NCT02677922|144703395|SUPERIORITY||Odds Ratio (OR)|8.65|||<|0.001|TWO_SIDED|95.0|2.74|27.31|||Chi-squared|||||27.31|2.74|<0.001
72586020|NCT02677922|144703396|SUPERIORITY||Odds Ratio (OR)|1.77||||0.1943|TWO_SIDED|95.0|0.74|4.2|||Chi-squared|||||4.20|0.74|0.1943
72586021|NCT02677922|144703399|SUPERIORITY||Cox Proportional Hazard|0.99||||0.972|TWO_SIDED|95.0|0.52|1.87|||Log Rank|Unstratified log-rank test|Cox proportional hazards regression model|||1.87|0.52|0.9720
72586022|NCT02677922|144703400|OTHER|Confidence interval of difference|Difference|2.6|||||TWO_SIDED|95.0|-17.3|22.5|||||The CI for the difference was derived using Greenwood's variance estimate.|||22.5|-17.3|
72586023|NCT04205643|144703425|SUPERIORITY||Difference estimated using CMH weights|21.1|||<|0.0001|TWO_SIDED|95.0|11.8|29.3||If the primary endpoint is significant, a fixed sequence procedure was employed to control the overall type I error rate of the key secondary endpoints.|Cochran-Mantel-Haenszel|Stratified by Previous biologic agent and/or JAK inhibitors exposure, Use of oral corticosteroids treatment at Week 0, Clinical remission at Week 10.|The 95% stratified Newcombe CI with CMH weights|||29.3|11.8|<0.0001
72586024|NCT03515811|144703430|OTHER||Percentage and confidence interval|10.6|||||TWO_SIDED|95.0|5.0|19.2|||||95% CI: 5.0%-19.2%|||19.2|5.0|
72586025|NCT03515811|144703430|OTHER||Percentage and confidence interval|0.0|||||TWO_SIDED|95.0|0.0|7.0|||||95% CI: 0.0%-7.0%|||7.0|0.0|
72586026|NCT03515811|144703431|OTHER||Percentage and confidence interval|6.6|||||TWO_SIDED|95.0|3.1|12.2|||||95% CI: 3.1%-12.2%|||12.2|3.1|
72586027|NCT04850989|144703515|SUPERIORITY||Mean Difference (Net)|-5.14|STANDARD_DEVIATION|0.49|<|0.05|TWO_SIDED||||||Mixed Models Analysis|||||||< 0.05
72586028|NCT04850989|144703516|SUPERIORITY||Mean Difference (Net)|-11.54|STANDARD_DEVIATION|-1.23|<|0.05|TWO_SIDED||||||Mixed Models Analysis|||||||< 0.05
72586029|NCT04850989|144703517|SUPERIORITY||Mean Difference (Net)|-8.08|STANDARD_DEVIATION|1.91|<|0.05|TWO_SIDED||||||Mixed Models Analysis|||||||< 0.05
72586030|NCT04850989|144703518|SUPERIORITY||Mean Difference (Net)|-8.08|STANDARD_DEVIATION|1.91|<|0.05|TWO_SIDED||||||Mixed Models Analysis|||||||< 0.05
72586031|NCT04850989|144703519|SUPERIORITY||Mean Difference (Net)|-3.48|STANDARD_DEVIATION|0.28|>|0.05|TWO_SIDED||||||Mixed Models Analysis|||||||> 0.05
72586032|NCT00915018|144703525|SUPERIORITY||Hazard Ratio (HR)|1.015||||0.8934|TWO_SIDED|95.0|0.813|1.269|||Log Rank|||||1.269|0.813|0.8934
72586033|NCT00915018|144703526|OTHER||Risk Difference (RD)|0.028||||0.5219|TWO_SIDED|95.0|-0.048|0.105|||Mantel Haenszel|||||0.105|-0.048|0.5219
72586034|NCT00915018|144703527|OTHER||Hazard Ratio (HR)|0.974||||0.8431|TWO_SIDED|95.0|0.752|1.262|||Log Rank|||||1.262|0.752|0.8431
72586035|NCT00915018|144703528|OTHER||Risk Difference (RD)|-0.032||||0.236|TWO_SIDED|95.0|-0.093|0.029|||Mantel Haenszel|||||0.029|-0.093|0.2360
72586036|NCT00915018|144703529|OTHER||Hazard Ratio (HR)|0.449||||0.0036|TWO_SIDED|95.0|0.259|0.78|||Log Rank|||||0.780|0.259|0.0036
72586037|NCT05253573|144703560|SUPERIORITY||Risk Ratio (RR)|1.85|||||TWO_SIDED|95.0|1.21|2.83||||||The overall number of participants analyzed reflects the cancer survivors and/or independent caregivers. Participants are not represented separately (as cancer survivors or caregivers) for each Arm. This is because the originally proposed statistical data analysis plan did not aim to analyze the data by each group of caregivers versus cancer patients/survivors (because the statistical power would be very low for doing so||2.83|1.21|
72586038|NCT01609010|144703574|SUPERIORITY_OR_OTHER|||||||0.3023|||||||Log Rank|||||||0.3023
72586039|NCT01609010|144703575|SUPERIORITY_OR_OTHER|||||||0.3362|||||||Chi-squared|||Week 10, Cycle 1||||0.3362
72586040|NCT01609010|144703575|SUPERIORITY_OR_OTHER|||||||0.1157|||||||Chi-squared|||Week 16, Cycle 2||||0.1157
72586041|NCT01609010|144703576|SUPERIORITY_OR_OTHER|||||||0.854|||||||Chi-squared|||Week 10, Cycle 1||||0.8540
72586042|NCT01609010|144703576|SUPERIORITY_OR_OTHER|||||||0.0051|||||||Chi-squared|||Week 16, Cycle 2||||0.0051
72586043|NCT01609010|144703578|SUPERIORITY_OR_OTHER|||||||0.784|||||||Log Rank|Stratification by previous treatment for lymphoma (yes or no).||CR+CRu+PR||||0.7840
72586044|NCT01609010|144703578|SUPERIORITY_OR_OTHER|||||||0.4419|||||||Log Rank|Stratification by previous treatment for lymphoma (yes or no).||CR+CRu||||0.4419
72586045|NCT01609010|144703578|SUPERIORITY_OR_OTHER|||||||0.5942|||||||Log Rank|Stratification by previous treatment for lymphoma (yes or no).||CR only||||0.5942
72586046|NCT01609010|144703580|SUPERIORITY_OR_OTHER|||||||0.8946|||||||Log Rank|Stratified by previous treatment for lymphoma (yes or no).||||||0.8946
72586047|NCT01609010|144703582|SUPERIORITY_OR_OTHER|||||||0.4963|||||||Log Rank|Stratified by previous treatment for lymphoma (yes or no).||||||0.4963
72586048|NCT00651261|144703583|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.78||||0.009|TWO_SIDED|95.0|0.63|0.96|||1-sided stratified log-rank|||||0.96|0.63|0.009
72586049|NCT00651261|144703584|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.78||||0.0024|TWO_SIDED|95.0|0.66|0.93|||1-sided stratified log rank|||||0.93|0.66|0.0024
72586050|NCT00651261|144703586|SUPERIORITY_OR_OTHER_LEGACY|||||||0.15|||||||Fisher Exact|||||||0.15
72586051|NCT00651261|144703587|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0049|||||||1-sided stratified log rank|||||||0.0049
72586052|NCT00687271|144703589|OTHER||Difference in Percentage Change|-10.0|||||TWO_SIDED|95.0|-14.6|-5.5|||Longitudinal Data Analysis (LDA) model|LDA model includes factors for time, treatment, baseline triglyceride (TG) category, and time-by treatment interactions.||||-5.5|-14.6|
72586053|NCT00687271|144703589|OTHER||Difference in Percentage Change|-17.9|||||TWO_SIDED|95.0|-23.4|-12.5|||LDA model|LDA model includes factors for time, treatment, baseline triglyceride (TG) category, and time-by treatment interactions.||||-12.5|-23.4|
72586054|NCT00687271|144703592|OTHER||Difference in Percentage Change|-8.6|||||TWO_SIDED|95.0|-12.7|-4.4|||LDA model|LDA model includes factors for time, treatment, baseline triglyceride (TG) category, and time-by treatment interactions.||||-4.4|-12.7|
72586055|NCT00687271|144703592|OTHER||Diffence in Percentage Change|-13.9|||||TWO_SIDED|95.0|-18.9|-8.9|||LDA model|LDA model includes factors for time, treatment, baseline triglyceride (TG) category, and time-by treatment interactions.||||-8.9|-18.9|
72586056|NCT00687271|144703593|OTHER||Difference in Percentage Change|-7.7|||||TWO_SIDED|95.0|-11.5|-3.9|||LDA model|LDA model includes factors for time, treatment, baseline triglyceride (TG) category, and time-by treatment interactions.||||-3.9|-11.5|
72586057|NCT00687271|144703593|OTHER||Difference in Percentage Change|-12.2|||||TWO_SIDED|95.0|-16.8|-7.6|||LDA model|LDA model includes factors for time, treatment, baseline triglyceride (TG) category, and time-by treatment interactions.||||-7.6|-16.8|
72586058|NCT00687271|144703594|OTHER||Difference in Percentage Change|-7.4|||||TWO_SIDED|95.0|-10.8|-4.1|||LDA model|LDA model includes factors for time, treatment, baseline triglyceride (TG) category, and time-by treatment interactions.||||-4.1|-10.8|
72586059|NCT00687271|144703594|OTHER||Difference in Percentage Change|-11.0|||||TWO_SIDED|95.0|-15.1|-7.0|||LDA model|LDA model includes factors for time, treatment, baseline triglyceride (TG) category, and time-by treatment interactions.||||-7.0|-15.1|
72586060|NCT00687271|144703595|OTHER||Dfferecne in Percentage Change|-2.4|||||TWO_SIDED|95.0|-6.6|1.8|||LDA model|LDA model includes factors for time, treatment, baseline triglyceride (TG) category, and time-by treatment interactions.||||1.8|-6.6|
72586061|NCT00687271|144703595|OTHER||Difference in Percentage Change|-0.7|||||TWO_SIDED|95.0|-5.8|4.4|||LDA model|LDA model includes factors for time, treatment, baseline triglyceride (TG) category, and time-by treatment interactions.||||4.4|-5.8|
72586062|NCT00687271|144703596|OTHER||Difference in Percentage Change|-1.0|||||TWO_SIDED|95.0|-7.7|5.9|||LDA model|LDA model includes factors for time, treatment, baseline triglyceride (TG) category, and time-by treatment interactions.||||5.9|-7.7|
72586063|NCT00687271|144703596|OTHER||Difference in Percentage Change|5.5|||||TWO_SIDED|95.0|-4.6|16.9|||LDA model|LDA model includes factors for time, treatment, baseline triglyceride (TG) category, and time-by treatment interactions.||||16.9|-4.6|
72586064|NCT02314260|144703597|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.917|STANDARD_ERROR_OF_MEAN|0.0318||0|TWO_SIDED|95.0|0.854|0.979||Under the nonparametric assumption. P-value \<0.05, means statistical significance|t-test, 2 sided||The positive actual state is failed induction and performing Caesarean Section, So as the numbers approaches 1, induction fails. the Y-axis of the curve is sensitivity and the x- axis is (1-Specificity).|Null hypothesis: true area = 0.5 The positive actual state is failed induction, the true positive rate (Sensitivity) is plotted in function of the false positive rate (100-Specificity)||0.979|0.854|0.000
72586065|NCT02314260|144703598|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.806|STANDARD_ERROR_OF_MEAN|0.0578||0|TWO_SIDED|95.0|0.693|0.919||Under the nonparametric assumption P value \<0.05 is statistically significant|t-test, 2 sided||The positive actual state is failed induction and performing Caesarean Section, So as the numbers approaches 1, induction fails. the Y-axis of the curve is sensitivity and the x- axis is (1-specificity).|Null hypothesis: true area = 0.5 The positive actual state is failed induction, the true positive rate (Sensitivity) is plotted in function of the false positive rate (100-Specificity)||0.919|0.693|0.000
72586066|NCT02314260|144703599|SUPERIORITY_OR_OTHER||Slope|4.5|STANDARD_ERROR_OF_MEAN|0.0318||0|TWO_SIDED|95.0|0.0|10.0||P\<0.05 is significant|t-test, 2 sided||at a cutoff value of 4.5, the sensitivity for failure to labour induction is 0.83 (83%), with a specificity of 0.87(87%).|The smallest cutoff value is the minimum observed test value minus 1, and the largest cutoff value is the maximum observed test value plus 1. All the other cutoff values are the averages of two consecutive ordered observed test values.||10|0.00|0.000
72586067|NCT02314260|144703600|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.5|STANDARD_ERROR_OF_MEAN|0.0578||0|TWO_SIDED|95.0|0.0|10.0||P\<0.05 is significant|t-test, 2 sided||at a cutoff value of 5.5, the sensitivity for failure to labour induction is 0.83 (83%), with a specificity of 0.73 (73%).|The smallest cutoff value is the minimum observed test value minus 1, and the largest cutoff value is the maximum observed test value plus 1. All the other cutoff values are the averages of two consecutive ordered observed test values.||10|0.00|0.000
72586068|NCT05483686|144703601|SUPERIORITY|||||||0.19|||||||Regression, Logistic|||This analysis aims to detect a significant change (p = .05) in percentage of participants with HIV transmission risk between Shine Intervention participants and Control Videos participants from Baseline to Month 6.||||.19
72586069|NCT05483686|144703602|SUPERIORITY||||||=|0.24|||||||Mixed Models Analysis|||This analysis aims to detect a significant change (p = .05) in ART adherence between Shine Intervention participants and Control Videos participants from Baseline to Month 6.||||=.24
72586070|NCT05483686|144703603|SUPERIORITY|||||||0.79|||||||Mixed Models Analysis|||This analysis aims to detect a significant change (p = .05) in condom use between Shine Intervention participants and Control Videos participants from Baseline to Month 6.||||.79
72586071|NCT05483686|144703604|SUPERIORITY|||||||0.81|||||||Mixed Models Analysis|||This analysis aims to detect a significant change (p = .05) in barriers to ART use between Shine Intervention participants and Control Videos participants from Baseline to Month 6.||||.81
72586072|NCT05483686|144703605|SUPERIORITY|||||||0.14|||||||Mixed Models Analysis|||This analysis aims to detect a significant change (p = .05) in barriers to PrEP use between Shine Intervention participants and Control Videos participants from Baseline to Month 6.||||.14
72586073|NCT05483686|144703606|SUPERIORITY|||||||0.81|||||||Mixed Models Analysis|||This analysis aims to detect a significant change (p = .05) in barriers to condom use between Shine Intervention participants and Control Videos participants from Baseline to Month 6.||||.81
72586074|NCT05483686|144703607|SUPERIORITY|||||||0.3|||||||Mixed Models Analysis|||This analysis aims to detect a significant change (p = .05) in social support between Shine Intervention participants and Control Videos participants from Baseline to Month 6.||||.30
72586075|NCT05483686|144703608|SUPERIORITY|||||||0.94|||||||Mixed Models Analysis|||This analysis aims to detect a significant change (p = .05) in gender identity comfort between Shine Intervention participants and Control Videos participants from Baseline to Month 6.||||.94
72586076|NCT01543178|144703609|SUPERIORITY_OR_OTHER|||||||0.0232|TWO_SIDED|||||The a priori threshold for statistical significance was p \< 0.05.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel method was adjusted for analysis center and time to recurrence during Maintenance Phase 1.||A worst case analysis was performed, in which patients with \< 4 days of IBS symptom data in a given week were considered as non-responders for that week.||||0.0232
72586077|NCT03351608|144703616|SUPERIORITY||GM Ratio (SUG 2 mg / NEO + [GLY or ATR])|0.22|||<|0.0001|TWO_SIDED|95.0|0.16|0.32|||ANOVA|||||0.32|0.16|< 0.0001
72586078|NCT02727478|144703619|SUPERIORITY||||||<|0.001|||||||ANOVA|||||||< 0.001
72586079|NCT02727478|144703620|SUPERIORITY||||||=|0.001|||||||ANOVA|||||||=0.001
72586080|NCT02727478|144703621|OTHER|||||||0.254|||||||Wilcoxon (Mann-Whitney)|||||||0.254
72586081|NCT02727478|144703622|SUPERIORITY||||||=|0.065|||||||Wilcoxon (Mann-Whitney)|||||||=0.065
72586082|NCT02727478|144703623|SUPERIORITY||||||=|0.301|||||||ANOVA|||||||=0.301
72586083|NCT02727478|144703624|SUPERIORITY||||||=|0.792|||||||ANOVA|||||||=0.792
72586084|NCT02727478|144703625|OTHER|||||||0.039|||||||Wilcoxon (Mann-Whitney)|||||||0.039
72586085|NCT02019264|144703661|NON_INFERIORITY|Hazard ratio was based on Cox-regression model including treatment and CV strata as covariates. MACE met non-inferiority when the one-sided upper bound of 97.5% confidence interval of the HR was less than 1.4 (the non-inferiority margin).|Hazard Ratio (HR)|1.005||||0.0001|TWO_SIDED|97.5|0.842|1.198|||Primary Analytic Method|||||1.198|0.842|0.0001
72586086|NCT02019264|144703662|SUPERIORITY|Hazard ratio was based on Cox-regression model including treatment and CV strata as covariates.|Hazard Ratio (HR)|0.969||||0.5464|TWO_SIDED|95.0|0.873|1.074|||Primary Analytic Method|||||1.074|0.873|0.5464
72586087|NCT02019264|144703663|SUPERIORITY|Hazard ratio was based on Cox-regression model including treatment as covariate.|Hazard Ratio (HR)|0.807||||0.038|TWO_SIDED|95.0|0.659|0.988|||Primary Analytic Method|||||0.988|0.659|0.0380
72586088|NCT02019264|144703664|NON_INFERIORITY|Myocardial Infarction: Hazard ratio was based on Cox-regression model including treatment and CV strata as covariates. 97.5% confidence interval refers to the upper limit of the displayed 2-sided 95% confidence interval.|Hazard Ratio (HR)|0.991||||0.0001|TWO_SIDED|97.5|0.824|1.191|||Primary Analytic Method|||||1.191|0.824|0.0001
72586089|NCT02019264|144703664|NON_INFERIORITY|Time to Stroke: Hazard ratio was based on Cox-regression model including treatment and CV strata as covariates. 97.5% CI refers to the upper limit of the displayed 2-sided 95% CI.|Hazard Ratio (HR)|0.856||||0.0005|TWO_SIDED|97.5|0.639|1.145|||Primary Analytic Method|||||1.145|0.639|0.0005
72586090|NCT02019264|144703664|NON_INFERIORITY|Cardiovascular Death: Hazard ratio was based on Cox-regression model including treatment and CV strata as covariates. 97.5% confidence interval refers to the upper limit of the displayed 2-sided 95% confidence interval.|Hazard Ratio (HR)|1.045||||0.0262|TWO_SIDED|97.5|0.778|1.404|||Primary Analytic Method|||||1.404|0.778|0.0262
72586091|NCT02019264|144703664|SUPERIORITY|Hospitalization for Unstable Angina: Hazard ratio was based on Cox-regression model including treatment and CV strata as covariates.|Hazard Ratio (HR)|1.163||||0.3243|TWO_SIDED|95.0|0.861|1.571|||Primary Analytic Method|||||1.571|0.861|0.3243
72586092|NCT02019264|144703664|SUPERIORITY|Heart Failure: Hazard ratio was based on Cox-regression model including treatment and CV strata as covariates.|Hazard Ratio (HR)|0.952||||0.6758|TWO_SIDED|95.0|0.757|1.197|||Primary Analytic Method|||||1.197|0.757|0.6758
72586093|NCT02019264|144703664|SUPERIORITY|Coronary Revascularization: Hazard ratio was based on Cox-regression model including treatment and CV strata as covariates.|Hazard Ratio (HR)|0.981||||0.7817|TWO_SIDED|95.0|0.856|1.125|||Primary Analytic Method|||||1.125|0.856|0.7817
72586094|NCT02019264|144703665|SUPERIORITY|Hazard ratio was based on Cox-regression model including treatment and CV strata as covariates.|Hazard Ratio (HR)|1.082||||0.4212|TWO_SIDED|95.0|0.893|1.31|||Primary Analytic Method|||||1.310|0.893|0.4212
72586095|NCT02019264|144703666|SUPERIORITY|Hazard ratio was based on a Cox regression model including treatment as covariate.|Hazard Ratio (HR)|1.124||||0.181|TWO_SIDED|95.0|0.947|1.333|||Primary Analytic Method|||||1.333|0.947|0.1810
72586096|NCT02019264|144703667|SUPERIORITY|Hazard ratio was based on a Cox regression model including treatment as covariate.|Hazard Ratio (HR)|0.773||||0.0116|TWO_SIDED|95.0|0.633|0.944|||Primary Analytic Method|||||0.944|0.633|0.0116
72586097|NCT02019264|144703668|SUPERIORITY||Least square (LS) Mean Difference (Net)|-0.39|||<|0.0001|TWO_SIDED|95.0|-0.43|-0.35||P-value was based on analysis of covariance (ANCOVA) model with treatment and stratification variable (presence of established CV disease or CV risk factors without established CV disease) as factors, and baseline HbA1c, as a covariate.|ANCOVA|||||-0.35|-0.43|<0.0001
72586098|NCT02019264|144703669|SUPERIORITY|Hazard ratio was based on Cox-regression model including treatment and CV strata as covariates.|Hazard Ratio (HR)|0.869||||0.0054|TWO_SIDED|95.0|0.787|0.959|||Primary Analytic Method|||||0.959|0.787|0.0054
72586099|NCT02019264|144703670|SUPERIORITY|Hazard ratio on a Cox regression model including treatment as covariate.|Hazard Ratio (HR)|0.904||||0.3661|TWO_SIDED|95.0|0.727|1.125|||Primary Analytic Method|||||1.125|0.727|0.3661
72586100|NCT02019264|144703671|SUPERIORITY||Hazard Ratio (HR)|0.855||||0.0082|TWO_SIDED|95.0|0.762|0.96|||Primary Analytic Method|||||0.960|0.762|0.0082
72586101|NCT02019264|144703672|SUPERIORITY|Hazard ratio was based on Cox-regression model including treatment and CV strata as covariates.|Hazard Ratio (HR)|1.182||||0.0297|TWO_SIDED|95.0|1.017|1.375|||Primary Analytic Method|||||1.375|1.017|0.0297
72586102|NCT02019264|144703673|SUPERIORITY||Odds Ratio (OR)|1.21||||0.5015|TWO_SIDED|95.0|0.69|2.11||P-value was based on logistic regression including treatment as a factor and baseline body mass index (BMI) as a covariate.|Regression, Logistic|||||2.11|0.69|0.5015
72586103|NCT02019264|144703674|SUPERIORITY||Odds Ratio (OR)|1.31||||0.7249|TWO_SIDED|95.0|0.29|5.98||P-value was based on logistic regression including treatment as a factor and baseline BMI as a covariate.|Regression, Logistic|||||5.98|0.29|0.7249
72586104|NCT02019264|144703675|SUPERIORITY||Least square (LS) Mean Difference (Net)|-0.9036||||0.2976|TWO_SIDED|95.0|-1.2908|-0.5163||P value was based on a mixed-effects model (unstructured covariance matrix) with repeated measures with treatment, month and treatment by month interaction as factors and baseline pulmonary arterial systolic pressure and baseline BMI as covariates.|Mixed-effects model|||||-0.5163|-1.2908|0.2976
72586105|NCT04994691|144703678|SUPERIORITY||Risk Ratio (RR)|1.92||||0|TWO_SIDED|95.0|1.38|2.6|||Regression, Logistic||Standard Message vs. No Message|||2.60|1.38|0.000
72586106|NCT04994691|144703678|SUPERIORITY||Risk Ratio (RR)|1.52||||0.023|TWO_SIDED|95.0|1.06|2.13|||Regression, Logistic||Tailored Message vs. No Message|||2.13|1.06|0.023
72586107|NCT04994691|144703678|SUPERIORITY||Risk Ratio (RR)|1.26||||0.124|TWO_SIDED|95.0|0.94|1.66|||Regression, Logistic||Standard Message vs. Tailored Message|||1.66|0.94|0.124
72586108|NCT04994691|144703679|SUPERIORITY||Risk Ratio (RR)|1.97||||0.001|TWO_SIDED|95.0|1.32|2.84|||Regression, Logistic||Standard Message vs. No Message|||2.84|1.32|0.001
72586109|NCT04994691|144703679|SUPERIORITY||Risk Ratio (RR)|1.57||||0.04|TWO_SIDED|95.0|1.02|2.34|||Regression, Logistic||Tailored Message vs. No Message|||2.34|1.02|0.040
72586110|NCT04994691|144703679|SUPERIORITY||Risk Ratio (RR)|1.26||||0.202|TWO_SIDED|95.0|0.88|1.74|||Regression, Logistic||Standard Message vs. Tailored Message|||1.74|0.88|0.202
72586111|NCT02573181|144703684|OTHER|Difference in percentage with AEs|Difference|4.2|||||TWO_SIDED|95.0|-7.4|15.8|||||Difference and 95% CI calculated based on Miettinen \& Nurminen method.|||15.8|-7.4|
72586112|NCT02573181|144703686|OTHER|Difference in % with fatigue|Fatigue difference|-0.9|||||TWO_SIDED|95.0|-10.7|8.8|||||Difference and 95% CI calculated based on the Miettinen \& Nurminen method.|||8.8|-10.7|
72586113|NCT02573181|144703686|OTHER|Difference in % with arthralgia|Arthralgia difference|-3.2|||||TWO_SIDED|95.0|-10.2|3.4|||||Difference and 95% CI calculated based on the Miettinen \& Nurminen method.|||3.4|-10.2|
72586114|NCT02573181|144703686|OTHER|Difference in % with myalgia|Myalgia difference|4.6|||||TWO_SIDED|95.0|-3.9|13.3|||||Difference and 95% CI calculated based on the Miettinen \& Nurminen method.|||13.3|-3.9|
72586115|NCT02573181|144703686|OTHER|Difference in % with headache|Headache difference|-2.5|||||TWO_SIDED|95.0|-11.4|6.4|||||Difference and 95% CI calculated based on the Miettinen \& Nurminen method.|||6.4|-11.4|
72586116|NCT01814696|144703704|SUPERIORITY_OR_OTHER_LEGACY|||||||0.605||||||a prior threshold p\<0.05|Fisher Exact|||||||0.605
72586117|NCT01814696|144703705|SUPERIORITY_OR_OTHER_LEGACY|||||||0.604|TWO_SIDED||||||Fisher Exact|||Heart failure related ED visits||||0.604
72586118|NCT01814696|144703705|SUPERIORITY_OR_OTHER_LEGACY|||||||1|TWO_SIDED||||||Fisher Exact|||Non-heart failure related ED visits||||1.000
72586119|NCT01814696|144703705|SUPERIORITY_OR_OTHER_LEGACY|||||||0.677|TWO_SIDED||||||Fisher Exact|||All cause ED visits||||0.677
72586120|NCT01814696|144703706|SUPERIORITY_OR_OTHER_LEGACY|||||||0.341|TWO_SIDED||||||Fisher Exact|||||||0.341
72586121|NCT01814696|144703706|SUPERIORITY_OR_OTHER_LEGACY|||||||0.042|TWO_SIDED||||||Fisher Exact|||||||0.042
72586122|NCT01814696|144703707|SUPERIORITY_OR_OTHER_LEGACY|||||||0.497|TWO_SIDED||||||Wilcoxon rank-sum test|||All cause||||0.497
72586123|NCT01814696|144703707|SUPERIORITY_OR_OTHER_LEGACY|||||||0.413|TWO_SIDED||||||Wilcoxon rank-sum test|||Heart failure related||||0.413
72586124|NCT01814696|144703707|SUPERIORITY_OR_OTHER_LEGACY|||||||0.944|TWO_SIDED||||||Wilcoxon rank-sum test|||Non-heart failure ED visits||||0.944
72586125|NCT01814696|144703708|SUPERIORITY_OR_OTHER_LEGACY|||||||0.057|TWO_SIDED||||||Wilcoxon rank-sum test|||All cause||||0.057
72586126|NCT01814696|144703708|SUPERIORITY_OR_OTHER_LEGACY|||||||0.236|TWO_SIDED||||||Wilcoxon rank-sum test|||Heart failure related||||0.236
72586127|NCT01814696|144703708|SUPERIORITY_OR_OTHER_LEGACY|||||||0.236|TWO_SIDED||||||Wilcoxon rank-sum test|||Non heart failure related||||0.236
72586128|NCT01814696|144703709|SUPERIORITY_OR_OTHER_LEGACY|||||||0.034|||||||Wilcoxon rank-sum test|||All cause||||0.034
72586129|NCT01814696|144703709|SUPERIORITY_OR_OTHER_LEGACY|||||||0.196|||||||Wilcoxon rank-sum test|||Heart failure related||||0.196
72586130|NCT01814696|144703709|SUPERIORITY_OR_OTHER_LEGACY|||||||0.21|TWO_SIDED||||||Wilcoxon rank-sum test|||Non heart failure related||||0.210
72586131|NCT01814696|144703710|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002|TWO_SIDED||||||t-test, 2 sided|||||||0.002
72586132|NCT02977572|144703740|SUPERIORITY_OR_OTHER|||||||1|||||||Chi-squared|||Based upon previous results, the investigators considered that the need for an intubation could be reduced by 15% \[19% in the CPAP group (control) vs. 4% in the NIV group (study)\]. The estimated sample size was 55 participants in each group (confidence interval \[1-α\] = 90% and power \[1-β\] = 85%).||||1.000
72586133|NCT01197534|144703763|SUPERIORITY_OR_OTHER||Weighted difference in proportions|0.15|||<|0.001|TWO_SIDED|95.0|0.08|0.22||Week 24|Mantel Haenszel|Treatment difference in proportion of responders using a Mantel Haenszel approach stratified by background use of DMARD and pooled country.||Non-responder imputation has been applied following premature withdrawal, or increased dose of DMARD or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||0.22|0.08|<0.001
72586134|NCT01197534|144703764|SUPERIORITY_OR_OTHER||Weighted difference in proportion|0.08|||<|0.001|TWO_SIDED|95.0|0.04|0.12|||Mantel Haenszel|95% confidence intervals and p-values are calculated using a Mantel Haenszel approach stratified by background use of DMARD and pooled country.||Non-responder imputation has been applied following premature withdrawal, or increased dose of DMARD or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||0.12|0.04|<0.001
72586135|NCT01197534|144703765|SUPERIORITY_OR_OTHER||Weighted difference in proportions|0.13|||<|0.001|TWO_SIDED|95.0|0.07|0.18|||Mantel Haenszel|95% confidence intervals and p-values are calculated using a Mantel Haenszel approach stratified by background use of DMARD and pooled country.||Non-responder imputation has been applied following premature withdrawal, or increased dose of DMARD or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||0.18|0.07|<0.001
72586136|NCT01197534|144703765|SUPERIORITY_OR_OTHER||Weighted difference in proportions|0.1|||<|0.001|TWO_SIDED|95.0|0.05|0.15|||Mantel Haenszel|95% confidence intervals and p-values are calculated using a Mantel Haenszel approach stratified by background use of DMARD and pooled country.||Non-responder imputation has been applied following premature withdrawal, or increased dose of DMARD or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||0.15|0.05|<0.001
72586137|NCT01197534|144703766|SUPERIORITY_OR_OTHER||Weighted difference in proportions|0.07|||<|0.001|TWO_SIDED|95.0|0.03|0.1|||Mantel Haenszel|95% confidence intervals and p-values are calculated using a Mantel Haenszel approach stratified by background use of DMARD and pooled country.||Non-responder imputation has been applied following premature withdrawal, or increased dose of DMARD or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||0.10|0.03|<0.001
72586138|NCT01197534|144703766|SUPERIORITY_OR_OTHER||Weighted difference in proportions|0.03||||0.033|TWO_SIDED|95.0|0.0|0.07|||Mantel Haenszel|95% confidence intervals and p-values are calculated using a Mantel Haenszel approach stratified by background use of DMARD and pooled country.||Non-responder imputation has been applied following premature withdrawal, or increased dose of DMARD or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||0.07|0.00|0.033
72586139|NCT01197534|144703767|SUPERIORITY_OR_OTHER||||||<|0.001||||||Nominal p-value presented for treatment comparison. Outcome was not formally tested within the predefined multiplicity procedure. As this is a non-parametric test, p-values alone are presented rather than an estimated treatment difference.|Van Elteren|P-values are estimated using the Van Elteren test stratified by background use of DMARD and pooled country.||Non-responder imputation has been applied following premature withdrawal, or increased dose of DMARD or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||||<0.001
72586140|NCT01197534|144703767|SUPERIORITY_OR_OTHER||||||<|0.001||||||Nominal p-value presented for treatment comparison. Outcome was not formally tested within the predefined multiplicity procedure. As this is a non-parametric test, p-values alone are presented rather than an estimated treatment difference.|Van Elteren|P-values are estimated using the Van Elteren test stratified by background use of DMARD and pooled country.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||||<0.001
72586141|NCT01197534|144703768|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|7.1|||<|0.001|TWO_SIDED|95.0|3.42|14.8|||Regression, Logistic|Odds ratio and 95% confidence intervals calculated using Logistic Regression with treatment, background use of DMARD and pooled country as factors.|An odds ratio \>1 indicates a benefit towards fostamatinib.|Non-responder imputation has been applied following premature withdrawal, or increased dose of DMARD or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||14.80|3.42|<0.001
72413828|NCT01306162|144336832|NON_INFERIORITY_OR_EQUIVALENCE|Bioavailability|Geometric mean ratio TrtE: TrtA (%)|126.0|STANDARD_DEVIATION|22.6||0.5164|TWO_SIDED|90.0|89.0|179.0||p-value for geometric mean ratio being outside interval 80% to 125%|ANOVA|ANOVA with sequence, period and treatment as fixed effects and subject within sequence as random effect.|The standard deviation is actually the Geometric coefficient of variation|150mg DE + 400mg DR bid 2h later (TrtE) vs 150mg DE (TrtA)||179|89|0.5164
72586142|NCT01197534|144703768|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.0|||<|0.001|TWO_SIDED|95.0|1.88|8.65|||Regression, Logistic|Odds ratio and 95% confidence intervals calculated using Logistic Regression with treatment, background use of DMARD and pooled country as factors.|An odds ratio \>1 indicates a benefit towards fostamatinib.|Non-responder imputation has been applied following premature withdrawal, or increased dose of DMARD or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||8.65|1.88|<0.001
72586143|NCT01197534|144703769|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|7.3|||<|0.001|TWO_SIDED|95.0|3.23|16.65|||Regression, Logistic|Odds ratio and 95% confidence intervals calculated using Logistic Regression with treatment, background use of DMARD and pooled country as factors.|An odds ratio \>1 indicates a benefit towards fostamatinib.|Non-responder imputation has been applied following premature withdrawal, or increased dose of DMARD or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||16.65|3.23|<0.001
72586144|NCT01197534|144703769|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.4|||<|0.001|TWO_SIDED|95.0|2.81|14.71|||Regression, Logistic|Odds ratio and 95% confidence intervals calculated using Logistic Regression with treatment, background use of DMARD and pooled country as factors.|An odds ratio \>1 indicates a benefit towards fostamatinib.|Non-responder imputation has been applied following premature withdrawal, or increased dose of DMARD or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||14.71|2.81|<0.001
72586145|NCT01197534|144703770|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.84|||<|0.001|TWO_SIDED|95.0|2.06|3.91||Nominal p-value presented for treatment comparison. Outcome was not formally tested within the predefined multiplicity procedure.|Proportional odds model|No Response, moderate response and good response are included in the model, with treatment, background use of DMARD and pooled country as factors.|An odds ratio \> 1 indicates a benefit towards fostamatinib.|Non-responder imputation has been applied following premature withdrawal, or increased dose of DMARD or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||3.91|2.06|<0.001
72586146|NCT01197534|144703770|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.44|||<|0.001|TWO_SIDED|95.0|1.77|3.37||Nominal p-value presented for treatment comparison. Outcome was not formally tested within the predefined multiplicity procedure.|Proportional odds model|No Response, moderate response and good response are included in the model, with treatment, background use of DMARD and pooled country as factors.|An odds ratio \> 1 indicates a benefit towards fostamatinib.|Non-responder imputation has been applied following premature withdrawal, or increased dose of DMARD or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||3.37|1.77|<0.001
72586147|NCT01197534|144703771|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.4|||<|0.001|TWO_SIDED|95.0|1.73|3.46|||Regression, Logistic|Odds ratio and 95% confidence intervals calculated using Logistic Regression with treatment, background use of DMARD and pooled country as factors.|An odds ratio \>1 indicates a benefit towards fostamatinib.|Non-responder imputation has been applied following premature withdrawal, or increased dose of DMARD or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||3.46|1.73|<0.001
72586148|NCT01197534|144703771|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.1|||<|0.001|TWO_SIDED|95.0|1.46|2.94|||Regression, Logistic|Odds ratio and 95% confidence intervals calculated using Logistic Regression with treatment, background use of DMARD and pooled country as factors.|An odds ratio \>1 indicates a benefit towards fostamatinib.|Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||2.94|1.46|<0.001
72586149|NCT01197534|144703772|SUPERIORITY_OR_OTHER|||||||0.904||||||As this is a non-parametric test, p-values alone are presented rather than an estimated treatment difference.|Cochran-Mantel-Haenszel|Residuals from ANCOVA are analysed using a Cochran-Mantel-Haenszel approach, adjusting for the effects of pooled country and background use of DMARD.||This analysis is performed using an ANCOVA model on the ranks of the change from baseline, by pooled country and background use of DMARD, including a term for the ranks of the baseline score as a covariate.||||0.904
72586150|NCT01197534|144703772|SUPERIORITY_OR_OTHER|||||||0.342||||||As this is a non-parametric test, p-values alone are presented rather than an estimated treatment difference.|Cochran-Mantel-Haenszel|Residuals from ANCOVA are analysed using a Cochran-Mantel-Haenszel approach, adjusting for the effects of pooled country and background use of DMARD.||This analysis is performed using an ANCOVA model on the ranks of the change from baseline, by pooled country and background use of DMARD, including a term for the ranks of the baseline score as a covariate.||||0.342
72586151|NCT01197534|144703773|SUPERIORITY_OR_OTHER||Treatment difference|2.47|||<|0.001|TWO_SIDED|95.0|1.47|3.48||Nominal p-value presented for treatment comparison. Outcome was not formally tested within the predefined multiplicity procedure.|ANCOVA|Including terms for baseline as continuous covariate and treatment, background use of DMARD and pooled country as factors.||Non-responder imputation has been applied following premature withdrawal, or increased dose of DMARD or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||3.48|1.47|<0.001
72586152|NCT01197534|144703773|SUPERIORITY_OR_OTHER||Treatment difference|1.64||||0.001|TWO_SIDED|95.0|0.63|2.65||Nominal p-value presented for treatment comparison. Outcome was not formally tested within the predefined multiplicity procedure.|ANCOVA|Including terms for baseline as continuous covariate and treatment, background use of DMARD and pooled country as factors.||Non-responder imputation has been applied following premature withdrawal, or increased dose of DMARD or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||2.65|0.63|0.001
72586153|NCT01197534|144703774|SUPERIORITY_OR_OTHER||Treatment difference|2.09|||<|0.001|TWO_SIDED|95.0|0.97|3.2||Nominal p-value presented for treatment comparison. Outcome was not formally tested within the predefined multiplicity procedure.|ANCOVA|Including terms for baseline as continuous covariate and treatment, background use of DMARD and pooled country as factors.||Non-responder imputation has been applied following premature withdrawal, or increased dose of DMARD or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||3.20|0.97|<0.001
72586154|NCT01197534|144703774|SUPERIORITY_OR_OTHER||Treatment difference|1.96|||<|0.001|TWO_SIDED|95.0|0.83|3.08||Nominal p-value presented for treatment comparison. Outcome was not formally tested within the predefined multiplicity procedure.|ANCOVA|Including terms for baseline as continuous covariate and treatment, background use of DMARD and pooled country as factors.||Non-responder imputation has been applied following premature withdrawal, or increased dose of DMARD or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||3.08|0.83|<0.001
72586155|NCT02589639|144703830|SUPERIORITY|The superiority of empagliflozin 10 mg against placebo was tested for change from baseline in HbA1c after 16 weeks of treatment at the level of α=0.05 (2-sided)|Mean Difference (Final Values)|-0.92|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001|TWO_SIDED|95.0|-1.11|-0.73|||ANCOVA|Analysis of Covariance (ANCOVA) comparing the change from baseline in HbA1c after 16 weeks of treatment||"The statistical model was:~Change from baseline in HbA1c after 16 weeks = overall mean + baseline HbA1c + treatment + baseline renal function + type of insulin therapies + random error"|Adjusted Mean Difference calculated as (Empagliflozin 10 mg - Placebo)|-0.73|-1.11|<0.0001
72586156|NCT02589639|144703830|SUPERIORITY|The superiority of empagliflozin 25 mg against placebo was tested for change from baseline in HbA1c after 16 weeks of treatment at the level of α=0.05 (2-sided)|Mean Difference (Final Values)|-1.0|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001|TWO_SIDED|95.0|-1.18|-0.82|||ANCOVA|Analysis of Covariance (ANCOVA) comparing the change from baseline in HbA1c after 16 weeks of treatment|Adjusted Mean Difference calculated as (Empagliflozin 10 mg - Placebo)|The statistical model was: Change from baseline in HbA1c after 16 weeks = overall mean + baseline HbA1c + treatment + baseline renal function + type of insulin therapies + random error||-0.82|-1.18|<0.0001
72586157|NCT01014169|144703832|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.13|||||TWO_SIDED|95.0|0.95|1.34||||||||1.34|0.95|
72586158|NCT01014169|144703833|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.11|||||TWO_SIDED|95.0|0.99|1.25||||||||1.25|0.99|
72586159|NCT01014169|144703834|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.12||||||95.0|1.0|1.25||||||||1.25|1.00|
72586160|NCT02593097|144703835|SUPERIORITY|||||||0.83|||||||Hills-Armitage|||||||0.83
72586161|NCT02593097|144703836|SUPERIORITY|||||||0.16|||||||McNemar|||||||0.16
72586162|NCT02811965|144703907|SUPERIORITY||||||<|5e-05||||||A priori threshold p \< 0.05|Repeated Measures ANOVA|||||||<0.00005
72586163|NCT02811965|144703907|SUPERIORITY|||||||5e-05||||||P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p\<0.05.|t-test, 2 sided|||||||0.00005
72586164|NCT02811965|144703907|SUPERIORITY||||||<|5e-05||||||P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p\<0.05.|t-test, 2 sided|||||||<0.00005
72586165|NCT02811965|144703907|SUPERIORITY||||||<|5e-05||||||P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p\<0.05.|t-test, 2 sided|||||||<0.00005
72586166|NCT02811965|144703907|SUPERIORITY||||||<|5e-05||||||P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p\<0.05.|t-test, 2 sided|||||||<0.00005
72586167|NCT02811965|144703907|SUPERIORITY||||||<|5e-05||||||P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p\<0.05.|t-test, 2 sided|||||||<0.00005
72586168|NCT02811965|144703907|SUPERIORITY||||||<|5e-05||||||P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p\<0.05.|t-test, 2 sided|||||||<0.00005
72586169|NCT02811965|144703907|SUPERIORITY||||||<|5e-05||||||P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p\<0.05.|t-test, 2 sided|||||||<0.00005
72586170|NCT02811965|144703907|SUPERIORITY|||||||0.01||||||P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p\<0.05.|t-test, 2 sided|||||||0.01
72586171|NCT02811965|144703907|SUPERIORITY|||||||0.0002||||||P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p\<0.05.|t-test, 2 sided|||||||0.0002
72586172|NCT02811965|144703907|SUPERIORITY||||||<|5e-05||||||P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p\<0.05.|t-test, 2 sided|||||||<0.00005
72586173|NCT02811965|144703907|SUPERIORITY||||||<|5e-05|||||||t-test, 2 sided|||||||<0.00005
72586174|NCT02811965|144703907|SUPERIORITY||||||<|5e-05||||||P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p\<0.05.|t-test, 2 sided|||||||<0.00005
72586175|NCT02811965|144703907|SUPERIORITY||||||<|5e-05||||||P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p\<0.05.|t-test, 2 sided|||||||<0.00005
72586176|NCT02811965|144703907|SUPERIORITY||||||<|5e-05||||||P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p\<0.05.|t-test, 2 sided|||||||<0.00005
72586177|NCT02811965|144703907|SUPERIORITY|||||||0.24||||||P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p\<0.05.|t-test, 2 sided|||||||0.24
72586178|NCT02811965|144703907|SUPERIORITY|||||||0.14||||||P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p\<0.05.|t-test, 2 sided|||||||0.14
72586179|NCT02811965|144703907|SUPERIORITY|||||||0.0093||||||P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p\<0.05.|t-test, 2 sided|||||||0.0093
72586180|NCT02811965|144703907|SUPERIORITY||||||<|5e-05||||||P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p\<0.05.|t-test, 2 sided|||||||<0.00005
72586181|NCT02811965|144703907|SUPERIORITY|||||||0.14||||||P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p\<0.05.|t-test, 2 sided|||||||0.14
72586182|NCT02811965|144703907|SUPERIORITY||||||<|5e-05||||||P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p\<0.05.|t-test, 2 sided|||||||<0.00005
72586183|NCT02811965|144703907|SUPERIORITY||||||<|5e-05||||||P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p\<0.05.|t-test, 2 sided|||||||<0.00005
72586184|NCT02811965|144703908|SUPERIORITY||||||<|5e-05||||||A priori threshold p\<0.05.|Repeated Measures ANOVA|||||||<0.00005
72586185|NCT02811965|144703908|SUPERIORITY||||||<|5e-05||||||P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p\<0.05.|t-test, 2 sided|||||||<0.00005
72586186|NCT02811965|144703908|SUPERIORITY||||||<|5e-05||||||P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p\<0.05.|t-test, 2 sided|||||||<0.00005
72586187|NCT02811965|144703908|SUPERIORITY||||||<|5e-05||||||P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p\<0.05.|t-test, 2 sided|||||||<0.00005
72586188|NCT02811965|144703908|SUPERIORITY||||||<|5e-05||||||P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p\<0.05.|t-test, 2 sided|||||||<0.00005
72586189|NCT02811965|144703908|SUPERIORITY||||||<|5e-05||||||P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p\<0.05.|t-test, 2 sided|||||||<0.00005
72586190|NCT02811965|144703908|SUPERIORITY||||||<|5e-05||||||P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p\<0.05.|t-test, 2 sided|||||||<0.00005
72586191|NCT02811965|144703908|SUPERIORITY||||||<|5e-05||||||P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p\<0.05.|t-test, 2 sided|||||||<0.00005
72586192|NCT02811965|144703908|SUPERIORITY|||||||0.0011||||||P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p\<0.05.|t-test, 2 sided|||||||0.0011
72586193|NCT02811965|144703908|SUPERIORITY|||||||5e-05||||||P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p\<0.05.|t-test, 2 sided|||||||0.00005
72586194|NCT02811965|144703908|SUPERIORITY||||||<|5e-05||||||P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p\<0.05.|t-test, 2 sided|||||||<0.00005
72586195|NCT02811965|144703908|SUPERIORITY||||||<|5e-05||||||P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p\<0.05.|t-test, 2 sided|||||||<0.00005
72586196|NCT02811965|144703908|SUPERIORITY||||||<|5e-05||||||P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p\<0.05.|t-test, 2 sided|||||||<0.00005
72586197|NCT02811965|144703908|SUPERIORITY||||||<|5e-05||||||P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p\<0.05.|t-test, 2 sided|||||||<0.00005
72586198|NCT02811965|144703908|SUPERIORITY||||||<|5e-05||||||P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p\<0.05.|t-test, 2 sided|||||||<0.00005
72586199|NCT02811965|144703908|SUPERIORITY|||||||0.53||||||P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p\<0.05.|t-test, 2 sided|||||||0.53
72586200|NCT02811965|144703908|SUPERIORITY|||||||0.092||||||P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p\<0.05.|t-test, 2 sided|||||||0.092
72586201|NCT02811965|144703908|SUPERIORITY|||||||0.0044|||||||t-test, 2 sided|||||||0.0044
72586202|NCT02811965|144703908|SUPERIORITY||||||<|5e-05||||||P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p\<0.05.|t-test, 2 sided|||||||<0.00005
72586203|NCT02811965|144703908|SUPERIORITY|||||||0.084||||||P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p\<0.05.|t-test, 2 sided|||||||0.084
72586204|NCT02811965|144703908|SUPERIORITY||||||<|5e-05||||||P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p\<0.05.|t-test, 2 sided|||||||<0.00005
72586205|NCT02811965|144703908|SUPERIORITY|||||||5e-05||||||P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p\<0.05.|t-test, 2 sided|||||||0.00005
72586206|NCT02748213|144703979|SUPERIORITY_OR_OTHER||Difference in Response Rates|2.2||||0.717|TWO_SIDED|95.0|-10.17|14.56|||Chi-squared||The approximate 95% CI for the difference in response (CR or PR) rates was determined using the Hauck-Anderson correction.|||14.56|-10.17|0.717
72586207|NCT02748213|144703981|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.73||||0.0449|TWO_SIDED|95.0|0.53|0.99|||Log Rank||Hazard Ratio (HR) calculated using Herceptin + Taxotere arm as reference.|||0.99|0.53|0.0449
72586208|NCT02748213|144703983|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.85||||0.4758|TWO_SIDED|95.0|0.56|1.32|||Log Rank||HR calculated using Herceptin + Taxotere arm as reference.|||1.32|0.56|0.4758
72586209|NCT00961350|144703987|SUPERIORITY_OR_OTHER||Proportions|3.8||||0.02||95.0|1.8|6.8|||Cochran-Mantel-Haenszel|CMH test stratified by NSAID use=COX-2, other NSAID, or NSAID use=NO at randomization.|The proportion is from the PA32540 treatment group.|The primary efficacy endpoint was the proportion of subjects with gastric ulcers throughout 6 months of treatment. The primary endpoint was analyzed with the CMH test stratified by NSAID use (COX-2/Other NSAID/No) at randomization. A sample size of 250 subjects/treatment would provide 86% power to detect the difference of 8% between EC aspirin 325 mg (13%) and PA32540 (5%) with a 2-sided significance of 5%; and, provides adequate power to test the key secondary endpoints in sequential order.||6.8|1.8|0.020
72586210|NCT00961350|144703988|SUPERIORITY_OR_OTHER|||||||0.002|||||||Cochran-Mantel-Haenszel|CMH test stratified by NSAID use=COX-2, other NSAID, or NSAID use=NO at randomization.||The cumulative proportion of subjects developing gastric ulcers and/or duodenal ulcers at 6 months was analyzed using the CMH test stratified by NSAID use=COX-2, other NSAID, or NSAID use=NO at randomization.||||0.002
72586211|NCT00961350|144703989|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|CMH test stratified by NSAID use=COX-2, other NSAID, or NSAID use=NO at randomization.||The cumulative proportion of subjects with Treatment Success was analyzed using the CMH test stratified by NSAID use=COX-2, other NSAID, or NSAID use=NO at randomization.||||<0.001
72586212|NCT00961350|144703990|SUPERIORITY_OR_OTHER|||||||0.002|||||||Cochran-Mantel-Haenszel|CMH test stratified by NSAID use=COX-2, other NSAID, or NSAID use=NO at randomization.||The cumulative proportion of subjects discontinuing from the study due to NSAID-associated upper GI adverse events was analyzed using the CMH test stratified by NSAID use=COX-2, other NSAID, or NSAID use=NO at randomization.||||0.002
72586213|NCT00961350|144703991|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|CMH test stratified by NSAID use=COX-2, other NSAID, or NSAID use=NO and by baseline heartburn severity at randomization.||The proportion of subjects who had no heartburn at 6 months (regardless of the presence or absence of heartburn at baseline) was analyzed using the CMH test stratified by NSAID use=COX-2, other NSAID, or NSAID use=NO at randomization.||||<0.001
72586214|NCT02640950|144704014|SUPERIORITY||||||<|0.001||||||Paired t test for pre and post treatment scores for all subjects|t-test, 2 sided|||Paired t-test of pre and post treatment scores on MADRS||||<0.001
72586215|NCT02640950|144704015|OTHER|Descriptive Frequencies Analysis|||||||||||||||||A frequencies analysis was conducted to determine the number of participants that were diagnosed with BP I and BP II as well as the number of participants that developed an onset of maniac symptoms during the 7 week treatment period.|||
72586216|NCT00300885|144704060|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.15||||0.915||95.0|0.94|1.41||According to protocol specified O'Brien-Fleming type alpha spending function and 384 deaths at interim analysis (IA), one-sided alpha value for IA was 0.0046.|Log Rank||Two treatment groups compared using one-sided log-rank test (Sorafenib+C/P over Placebo+C/P) with overall alpha of 0.025 stratified by same stratification factors as randomization|Sample size based on primary efficacy endpoint of OS. Clinically meaningful improvement defined as 30% improvement in median OS (i.e. HR of 0.76923, Sorafenib+C/P over Placebo+C/P -Null: theta\>=1, Alternative: theta\<=0.76923). With overall one-sided alpha of 0.025, 90% power and randomization of 1:1, one formal interim analysis and one final analysis were planned using O'Brien-Fleming type error spending function, and a total of 614 events (deaths) were required.||1.41|0.94|0.915
72586217|NCT00300885|144704061|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.99||||0.433||95.0|0.84|1.16|||Log Rank|||Two treatment groups compared using one-sided log-rank test (Sorafenib+C/P over Placebo+C/P) with alpha of 0.025 stratified by same stratification factors at randomization||1.16|0.84|0.433
72586218|NCT00300885|144704062|SUPERIORITY_OR_OTHER||difference in response rate (CR+PR rate)|-3.65||||0.1015||95.0|-9.18|1.89||no adjustments|Cochran-Mantel-Haenszel||difference in response rates (Complete Response (CR) + Partial Response (PR)) = Placebo+C/P - Sorafenib+C/P|Objective response rate (ie. CR+PR rate) was compared between treatment arms using Cochran-Mantel-Haenszel test with one-side alpha 0.025 adjusting for same stratification factors as randomization||1.89|-9.18|0.1015
72586219|NCT00603902|144704066|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio, log|2.69|||<|0.0001|TWO_SIDED|95.0|2.31|3.13|||Regression, Logistic|Adjustments for baseline body weight.||||3.13|2.31|<0.0001
72413829|NCT00833989|144336873|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.45|STANDARD_ERROR_OF_MEAN|0.231|||TWO_SIDED|95.0|-0.03|0.92|||Mixed Model Repeated Measure Analysis||Mean difference = GSK249320 1 mg/kg - Placebo|Placebo Vs GSK249320 1 mg/kg, Visit 4||0.92|-0.03|
72586220|NCT00603902|144704067|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.0|||<|0.0001|TWO_SIDED|95.0|-3.44|-2.56|||ANCOVA|||||-2.56|-3.44|<0.0001
72586221|NCT01134107|144704094|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin of 0.6 mmol/L was used.|Least Squares Mean Difference|0.36|||||TWO_SIDED|95.0|0.06|0.66|||||Least Squares Mean Difference = Insulin Lispro 6 Day minus Insulin Aspart 6 Day; adjusted for Treatment + Sequence + Period + Baseline HbA1c|This was the primary gated analysis.||0.66|0.06|
72413830|NCT00833989|144336873|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.69|STANDARD_ERROR_OF_MEAN|0.214|||TWO_SIDED|95.0|0.25|1.13|||Mixed Model Repeated Measure Analysis||Mean difference = GSK249320 5 mg/kg - Placebo|Placebo Vs GSK249320 5 mg/kg, Visit 4||1.13|0.25|
72413831|NCT00833989|144336873|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.3|STANDARD_ERROR_OF_MEAN|0.246|||TWO_SIDED|95.0|-0.2|0.8|||Mixed Model Repeated Measure Analysis||Mean difference= GSK249320 15 mg/kg - Placebo|Placebo Vs GSK249320 15 mg/kg, Visit 4||0.80|-0.20|
72586222|NCT01134107|144704095|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin of 0.6 mmol/L was used.|Least Squares Mean Difference|0.18|||||TWO_SIDED|95.0|-0.1|0.47|||||Least Squares Mean Difference = Insulin Lispro 6 Day (Day 1-6) minus Insulin Aspart 6 Day (Day 1-6); adjusted for Treatment + Sequence + Period + Baseline HbA1c|||0.47|-0.10|
72586223|NCT01134107|144704095|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin of 0.6 mmol/L was used.|Least Squares Mean Difference|0.42|||||TWO_SIDED|95.0|0.25|0.58|||||Least Squares Mean Difference = Insulin Lispro 6 Day (Day 6) minus Insulin Lispro 6 Day (Day 2); adjusted for DayGroup + Period + Baseline HbA1c|||0.58|0.25|
72586224|NCT01134107|144704096|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.38|||||TWO_SIDED|95.0|-0.13|0.88|||||Daily Total Insulin: Least Squares Mean Difference = Insulin Lispro 6 Day minus Insulin Aspart 6 Day; adjusted for Treatment + Sequence + Period + Baseline Insulin Basal/Bolus/Total Dose|||0.88|-0.13|
72586225|NCT01134107|144704096|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.02|||||TWO_SIDED|95.0|-0.26|0.31|||||Daily Basal Insulin: Least Squares Mean Difference = Insulin Lispro 6 Day minus Insulin Aspart 6 Day; adjusted for Treatment + Sequence + Period + Baseline Insulin Basal/Bolus/Total Dose|||0.31|-0.26|
72586226|NCT01134107|144704096|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.23|||||TWO_SIDED|95.0|-0.15|0.6|||||Daily Bolus Insulin: Least Squares Mean Difference = Insulin Lispro 6 Day minus Insulin Aspart 6 Day; adjusted for Treatment + Sequence + Period + Baseline Insulin Basal/Bolus/Total Dose|||0.60|-0.15|
72586227|NCT01134107|144704097|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.16|||||TWO_SIDED|95.0|0.08|0.24|||||Least Squares Mean Difference = Insulin Lispro 6 Day minus Insulin Aspart 6 Day; adjusted for Treatment + Period + Sequence + Baseline HbA1c|||0.24|0.08|
72586228|NCT01134107|144704098|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.8|||||TWO_SIDED|95.0|0.39|1.63|||||Odds Ratio of HbA1c ≤6.5% for Insulin Lispro 6 Day versus Insulin Aspart 6 Day.|||1.63|0.39|
72586229|NCT01134107|144704098|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.36|||||TWO_SIDED|95.0|0.2|0.63|||||Odds Ratio of HbA1c \<7% for Insulin Lispro 6 Day versus Insulin Aspart 6 Day.|||0.63|0.20|
72586230|NCT01134107|144704099|SUPERIORITY_OR_OTHER|||||||0.595||95.0||||P-value for Total Insulin Dose computed using Crossover model: Variable = Treatment + Sequence + Period + Baseline Insulin Total Dose.|Crossover Model|||||||0.595
72586231|NCT01134107|144704099|SUPERIORITY_OR_OTHER|||||||0.506||95.0||||P-value for Basal Insulin Dose computed using Crossover model: Variable = Treatment + Sequence + Period + Baseline Insulin Basal Dose.|Crossover Model|||||||0.506
72586232|NCT01134107|144704099|SUPERIORITY_OR_OTHER|||||||0.79||95.0||||P-value for Bolus Insulin Dose computed using Crossover model: Variable = Treatment + Sequence + Period + Baseline Insulin Bolus Dose.|Crossover Model|||||||0.790
72586233|NCT01134107|144704101|SUPERIORITY_OR_OTHER|||||||0.059||95.0|||||negative binomial test|P-value computed using a negative binomial test including factors for treatment, period and sequence.||||||0.059
72586234|NCT01134107|144704102|SUPERIORITY_OR_OTHER|||||||1||95.0||||P-value for overall pump complications associated with a premature reservoir change computed using Gart's Test. Participants represented in both treatment groups and with non-missing incidence value in each treatment period are used.|Gart's Test|||||||1.00
72586235|NCT01134107|144704102|SUPERIORITY_OR_OTHER|||||||0.472||95.0||||P-value for overall pump complications associated with a premature infusion set change computed using Gart's Test. Participants represented in both treatment groups and with non-missing incidence value in each treatment period are used.|Gart's Test|||||||0.472
72586236|NCT01134107|144704103|SUPERIORITY_OR_OTHER|||||||0.383||95.0||||P-value for Premature Reservoir Change computed using negative binomial test including factors for treatment, period and sequence.|negative binomial test|||||||0.383
72586237|NCT01134107|144704103|SUPERIORITY_OR_OTHER|||||||0.499||95.0||||P-value for Premature Infusion Set Change computed using negative binomial test including factors for treatment, period and sequence.|negative binomial test|||||||0.499
72586238|NCT01134107|144704104|SUPERIORITY_OR_OTHER|||||||1||95.0||||The p-value is for the Documented Hypoglycemic Episodes category treatment arm comparison. The p-value for the All Reported Hypoglycemic Episodes category could not be generated using Gart's Test.|Gart's Test|Participants represented in both treatment groups, and with non-missing incidence value in each treatment period, were used for p-value calculation.||||||1.00
72586239|NCT01134107|144704105|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Negative Binomial Test|P-value computed using a negative binomial test including factors for treatment, period and sequence.||||||<0.001
72586240|NCT01134107|144704106|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Crossover Model|P-value computed using crossover model. Response = treatment + sequence + period + baseline body weight||||||<0.001
72413832|NCT00833989|144336873|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.35|STANDARD_ERROR_OF_MEAN|0.292|||TWO_SIDED|95.0|-0.24|0.95|||Mixed Model Repeated Measure Analysis||Mean difference= GSK249320 1 mg/kg - Placebo|Placebo Vs GSK249320 1 mg/kg, Visit 5||0.95|-0.24|
72413833|NCT00833989|144336873|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.52|STANDARD_ERROR_OF_MEAN|0.279|||TWO_SIDED|95.0|-0.05|1.09|||Mixed Model Repeated Measure Analysis||Mean difference= GSK249320 5 mg/kg- Placebo|Placebo Vs GSK249320 5 mg/kg, Visit 5||1.09|-0.05|
72413834|NCT00833989|144336873|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.04|STANDARD_ERROR_OF_MEAN|0.319|||TWO_SIDED|95.0|-0.61|0.69|||Mixed Model Repeated Measure Analysis||Mean difference= GSK249320 15 mg/kg - Placebo|Placebo Vs GSK249320 15 mg/kg, Visit 5||0.69|-0.61|
72413835|NCT00833989|144336873|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.63|STANDARD_ERROR_OF_MEAN|0.235|||TWO_SIDED|95.0|0.15|1.11|||Mixed Model Repeated Measure Analysis||Mean difference= GSK249320 1 mg/kg - Placebo|Placebo Vs GSK249320 1 mg/kg, Visit 6||1.11|0.15|
72413836|NCT00833989|144336873|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.4|STANDARD_ERROR_OF_MEAN|0.225|||TWO_SIDED|95.0|-0.06|0.86|||Mixed Model Repeated Measure Analysis||Mean difference= GSK249320 5 mg/kg - Placebo|Placebo Vs GSK249320 5 mg/kg, Visit 6||0.86|-0.06|
72586241|NCT01134107|144704107|SUPERIORITY_OR_OTHER|||||||0.147||95.0||||P-value for the Systolic Blood Pressure (SBP) computed using crossover model. Response = treatment + sequence + period + baseline systolic blood pressure.|Crossover Model|||||||0.147
72586242|NCT01134107|144704107|SUPERIORITY_OR_OTHER|||||||0.894||95.0||||P-value for Diastolic Blood Pressure (DBP) computed using crossover model. Response = treatment + sequence + period + baseline diastolic blood pressure.|Crossover Model|||||||0.894
72586243|NCT02362672|144704109|SUPERIORITY||Mean Difference (Net)|-0.55||||0.0019|TWO_SIDED||||||z-test|||NKTR-181 (Double-blind Treatment Phase), Placebo (Double-blind Treatment Phase)||||0.0019
72586244|NCT02801617|144704131|NON_INFERIORITY|it will be considered not inferior if they keep the IOP goal with differences of no more than 2 mmHg analysis by protocol||||||0.861|||||||t-test, 2 sided|||||||0.861
72586245|NCT02801617|144704131|NON_INFERIORITY|it will be considered not inferior if they keep the TIOP with differences of no more than 2 mmHg||||||0.89|||||||t-test, 2 sided|||||||0.890
72586246|NCT02801617|144704132|NON_INFERIORITY|intention-to-treat analysis (ITT)||||||0.329|||||||Chi-squared|||||||0.329
72586247|NCT02801617|144704133|NON_INFERIORITY|it will be considered not inferior if they keep the percentage of ocular burning with differences of no more than 20%||||||0.388|||||||Chi-squared, Corrected|||||||0.388
72586248|NCT02801617|144704134|NON_INFERIORITY|it will be considered not inferior if they keep the percentage of ocular burning with differences of no more than 20%||||||0.125|||||||Chi-squared, Corrected|||||||0.125
72586249|NCT02801617|144704135|NON_INFERIORITY|it will be considered not inferior if they keep the percentage of ocular burning with differences of no more than 20%||||||0.434|||||||Chi-squared, Corrected|||||||0.434
72586250|NCT02801617|144704136|NON_INFERIORITY|it will be considered not inferior if they keep the percentage of ocular burning with differences of no more than 20%||||||0|||||||Chi-squared, Corrected|||||||0
72586251|NCT02801617|144704137|NON_INFERIORITY|it will be considered not inferior if they keep the percentage of ocular burning with differences of no more than 20%||||||0.039|||||||Chi-squared|||||||0.039
72586252|NCT06110494|144704157|OTHER|Pairwise comparisons were done using Mann-Whitney U test of log10 transformed CFU reduction data to compare the antimicrobial effectiveness.||||||0.05||||||Pairwise comparisons were done using Mann-Whitney U test of log 10 transformed data to compare the antimicrobial effectiveness of Fer/H2O2 in comparison with the negative (saline) and positive (NaOCl) controls with P values set at \< 0.05|Wilcoxon (Mann-Whitney)|||The sample size estimate was calculated in Pass Software 2021, using a test that compares the ratio of two means from independent samples using data that has been log-normalized. An alpha of 0.05 and power of 80% was assumed, with means and standard deviations pulled from previous studies that employed similar methodology. This produced a required sample size of 16 for each group. Pairwise comparisons were done using Mann-Whitney U test to compare the antimicrobial effectiveness.||||0.05
72586253|NCT03612596|144704179|SUPERIORITY|||||||0.94|||||||t-test, 2 sided|||||||0.94
72586254|NCT03612596|144704180|SUPERIORITY|||||||0.88|||||||t-test, 2 sided|||||||0.88
72586255|NCT03612596|144704181|SUPERIORITY|||||||0.94|||||||t-test, 2 sided|||||||0.94
72586256|NCT03612596|144704182|SUPERIORITY|||||||0.58|||||||t-test, 2 sided|||||||0.58
72586257|NCT03612596|144704183|SUPERIORITY|||||||0.17|||||||t-test, 2 sided|||||||0.17
72586258|NCT03612596|144704184|SUPERIORITY|||||||0.53|||||||t-test, 2 sided|Please note that this analysis was not powered and was used to characterize effect size (d = 1.26) rather than test efficacy.||||||0.53
72586259|NCT03612596|144704185|SUPERIORITY|||||||0.44|||||||t-test, 2 sided|Please note that this analysis was not powered and was used to characterize effect size (d = 1.16) rather than test efficacy.||||||0.44
72586260|NCT03612596|144704186|SUPERIORITY|||||||0.93|||||||t-test, 2 sided|Please note that this analysis was not powered and was used to characterize effect size (d = 0.67) rather than test efficacy.||||||0.93
72586261|NCT03612596|144704187|SUPERIORITY|||||||0.29|||||||t-test, 2 sided|||||||0.29
72586262|NCT03612596|144704188|SUPERIORITY|||||||0.16|||||||t-test, 2 sided|||||||0.16
72586263|NCT03612596|144704189|SUPERIORITY|||||||0.02|||||||t-test, 2 sided|||||||0.02
72413837|NCT00833989|144336873|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.24|STANDARD_ERROR_OF_MEAN|0.259|||TWO_SIDED|95.0|-0.29|0.77|||Mixed Model Repeated Measure Analysis||Mean difference= GSK249320 15 mg/kg - Placebo|Placebo Vs GSK249320 15 mg/kg, Visit 6||0.77|-0.29|
72413838|NCT00833989|144336873|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.61|STANDARD_ERROR_OF_MEAN|0.251|||TWO_SIDED|95.0|0.1|1.12|||Mixed Model Repeated Measure Analysis||Mean difference= GSK249320 1 mg/kg - Placebo|Placebo Vs GSK249320 1 mg/kg, Visit 7||1.12|0.10|
72413839|NCT00833989|144336873|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.59|STANDARD_ERROR_OF_MEAN|0.242|||TWO_SIDED|95.0|0.09|1.08|||Mixed Model Repeated Measure Analysis||Mean difference= GSK249320 5 mg/kg - Placebo|Placebo Vs GSK249320 5 mg/kg, Visit 7||1.08|0.09|
72413840|NCT00833989|144336873|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.17|STANDARD_ERROR_OF_MEAN|0.277|||TWO_SIDED|95.0|-0.39|0.73|||Mixed Model Repeated Measure Analysis||Mean difference= GSK249320 15 mg/kg - Placebo|Placebo Vs GSK249320 5 mg/kg, Visit 7||0.73|-0.39|
72586264|NCT03612596|144704190|SUPERIORITY|||||||0.7|||||||t-test, 2 sided|||||||0.70
72586265|NCT03612596|144704191|SUPERIORITY|||||||0.71|||||||t-test, 2 sided|||||||0.71
72586266|NCT03421210|144704205|OTHER|||||||0.001|||||||t-test, 1 sided|||Differences in brain activation in response to personal smoking versus standard smoking cues were examined.||||0.001
72586267|NCT03777436|144704208|SUPERIORITY||Adjusted difference|20.1||||0.0003|TWO_SIDED|95.0|9.2|30.9|||Cochran-Mantel-Haenszel||Adjusted difference is the weighted average of the treatment differences across the strata with the Cochran-Mantel-Haenszel (CMH) weights. 2-sided 95% CIs based on the stratified Newcombe method. Two-sided p-values were based on the CMH test.|||30.9|9.2|0.0003
72413841|NCT00833989|144336874|SUPERIORITY_OR_OTHER||Mean Difference (Net)|9.56|STANDARD_ERROR_OF_MEAN|4.981|||TWO_SIDED|95.0|-0.6|19.71|||Mixed Model Repeated Measures Analysis||Mean difference =GSK249320 1 mg/kg - Placebo|Placebo Vs GSK249320 1 mg/kg, visit 4||19.71|-0.60|
72413842|NCT00833989|144336874|SUPERIORITY_OR_OTHER||Mean Difference (Net)|8.47|STANDARD_ERROR_OF_MEAN|4.801|||TWO_SIDED|95.0|-1.32|18.26|||Mixed Model Repeated Measures Analysis||Mean difference= GSK249320 5 mg/kg - Placebo|Placebo Vs GSK249320 5 mg/kg, Visit 4||18.26|-1.32|
72413843|NCT00833989|144336874|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.09|STANDARD_ERROR_OF_MEAN|5.47|||TWO_SIDED|95.0|-11.1|11.24|||Mixed Model Repeated Measures Analysis||Mean difference= GSK249320 GSK249320 15 mg/kg - Placebo|Placebo Vs GSK249320 15 mg/kg, Visit 4||11.24|-11.1|
72413844|NCT00833989|144336874|SUPERIORITY_OR_OTHER||Mean Difference (Net)|11.58|STANDARD_ERROR_OF_MEAN|5.631|||TWO_SIDED|95.0|0.01|23.15|||Mixed Model Repeated Measures Analysis||Mean difference= GSK249320 1 mg/kg - Placebo|Placebo Vs GSK249320 1 mg/kg, Visit 5||23.15|0.01|
72413845|NCT00833989|144336874|SUPERIORITY_OR_OTHER||Mean Difference (Net)|8.77|STANDARD_ERROR_OF_MEAN|5.411|||TWO_SIDED|95.0|-2.35|19.89|||Mixed Model Repeated Measures Analysis||Mean difference= GSK249320 5 mg/kg - Placebo|Placebo Vs GSK249320 5 mg/kg, Visit 5||19.89|-2.35|
72413846|NCT00833989|144336874|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.49|STANDARD_ERROR_OF_MEAN|6.195|||TWO_SIDED|95.0|-12.2|13.21|||Mixed Model Repeated Measures Analysis||Mean difference= GSK249320 15 mg/kg - Placebo|Placebo Vs GSK249320 15 mg/kg, Visit 5||13.21|-12.2|
72413847|NCT00833989|144336874|SUPERIORITY_OR_OTHER||Mean Difference (Net)|9.66|STANDARD_ERROR_OF_MEAN|5.351|||TWO_SIDED|95.0|-1.34|20.66|||Mixed Model Repeated Measures Analysis||Mean difference= GSK249320 1 mg/kg - Placebo|Placebo Vs GSK249320 1 mg/kg, Visit 6||20.66|-1.34|
72413848|NCT00833989|144336874|SUPERIORITY_OR_OTHER||Mean Difference (Net)|7.45|STANDARD_ERROR_OF_MEAN|5.198|||TWO_SIDED|95.0|-3.22|18.13|||Mixed Model Repeated Measures Analysis||Mean difference= GSK249320 5 mg/kg - Placebo|Placebo Vs GSK249320 5 mg/kg, Visit 6||18.13|-3.22|
72413849|NCT00833989|144336874|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-10.63|STANDARD_ERROR_OF_MEAN|5.959|||TWO_SIDED|95.0|-22.9|1.6|||Mixed Model Repeated Measures Analysis||Mean difference= GSK249320 15 mg/kg - Placebo|Placebo Vs GSK249320 15 mg/kg, Visit 6||1.60|-22.9|
72413850|NCT00833989|144336874|SUPERIORITY_OR_OTHER||Mean Difference (Net)|9.59|STANDARD_ERROR_OF_MEAN|6.134|||TWO_SIDED|95.0|-3.07|22.24|||Mixed Model Repeated Measures Analysis||Mean difference= GSK249320 1 mg/kg - Placebo|Placebo Vs GSK249320 1 mg/kg, visit 7||22.24|-3.07|
72586268|NCT03777436|144704209|SUPERIORITY||Adjusted difference|15.2||||0.0004|TWO_SIDED|95.0|6.9|23.6|||Cochran-Mantel-Haenszel||Adjusted difference is the weighted average of the treatment differences across the strata with the CMH weights. 2-sided 95% CIs based on the stratified Newcombe method. Two-sided p-values were based on the CMH test.|||23.6|6.9|0.0004
72413851|NCT00833989|144336874|SUPERIORITY_OR_OTHER||Mean Difference (Net)|5.89|STANDARD_ERROR_OF_MEAN|5.948|||TWO_SIDED|95.0|-6.37|18.15|||Mixed Model Repeated Measures Analysis||Mean difference= GSK249320 5 mg/kg - Placebo|Placebo Vs GSK249320 5 mg/kg, Visit 7||18.15|-6.37|
72413852|NCT00833989|144336874|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.11|STANDARD_ERROR_OF_MEAN|6.768|||TWO_SIDED|95.0|-17.1|10.84|||Mixed Model Repeated Measures Analysis||Mean difference= GSK249320 15 mg/kg - Placebo|Placebo Vs GSK249320 15 mg/kg, Visit 7||10.84|-17.1|
72413853|NCT00833989|144336875|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.47|STANDARD_ERROR_OF_MEAN|7.047|||TWO_SIDED|95.0|-15.81|12.86|||Mixed Model Repeated Measures Analysis||"Mean difference= GSK249320 1 mg/kg - Placebo.~Change in Total Fugl-Meyer assessment= Treatment + Visit + Treatment \* Visit + Baseline"|Placebo Vs GSK249320 1 mg/kg, Visit 4||12.86|-15.81|
72413854|NCT00833989|144336875|SUPERIORITY_OR_OTHER||Median Difference (Net)|9.86|STANDARD_ERROR_OF_MEAN|6.852|||TWO_SIDED|95.0|-4.08|23.8|||Mixed Model Repeated Measures Analysis||"Mean difference= GSK249320 5 mg/kg - Placebo.~Change in Total Fugl-Meyer assessment= Treatment + Visit + Treatment \* Visit + Baseline"|Placebo Vs GSK249320 5 mg/kg, Visit 4||23.80|-4.08|
72413855|NCT00833989|144336875|SUPERIORITY_OR_OTHER||Median Difference (Net)|-5.4|STANDARD_ERROR_OF_MEAN|7.376|||TWO_SIDED|95.0|-20.41|9.6|||Mixed Model Repeated Measures Analysis||"Mean difference= GSK249320 15 mg/kg - Placebo.~Change in Total Fugl-Meyer assessment= Treatment + Visit + Treatment \* Visit + Baseline"|Placebo Vs GSK249320 15 mg/kg, Visit 4||9.60|-20.41|
72413856|NCT00833989|144336875|SUPERIORITY_OR_OTHER||Median Difference (Net)|-2.4|STANDARD_ERROR_OF_MEAN|10.04|||TWO_SIDED|95.0|-22.87|18.07|||Mixed Model Repeated Measures Analysis||"Mean difference= GSK249320 1 mg/kg - Placebo.~Change in Total Fugl-Meyer assessment= Treatment + Visit + Treatment \* Visit + Baseline"|Placebo Vs GSK249320 1 mg/kg, Visit 7||18.07|-22.87|
72413857|NCT00833989|144336875|SUPERIORITY_OR_OTHER||Mean Difference (Net)|5.03|STANDARD_ERROR_OF_MEAN|10.31|||TWO_SIDED|95.0|-15.95|26.0|||Mixed Model Repeated Measures Analysis||"Mean difference= GSK249320 5 mg/kg - Placebo.~Change in Total Fugl-Meyer assessment= Treatment + Visit + Treatment \* Visit + Baseline"|Placebo Vs GSK249320 5 mg/kg, Visit 7||26.00|-15.95|
72413858|NCT00833989|144336875|SUPERIORITY_OR_OTHER||Median Difference (Net)|-10.07|STANDARD_ERROR_OF_MEAN|10.916|||TWO_SIDED|95.0|-32.29|12.15|||Mixed Model Repeated Measures Analysis||"Mean difference= GSK249320 15 mg/kg - Placebo~Change in Total Fugl-Meyer assessment= Treatment + Visit + Treatment \* Visit + Baseline"|Placebo Vs GSK249320 15 mg/kg, Visit 7||12.15|-32.29|
72413859|NCT00833989|144336876|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.13|STANDARD_ERROR_OF_MEAN|5.147|||TWO_SIDED|95.0|-10.4|10.61|||Mixed Model Repeated Measures Analysis||"Mean difference= GSK249320 1 mg/kg - Placebo~Affected Change from Baseline = Treatment + Visit + Treatment \* Visit + Affected Baseline + Unaffected Baseline"|Placebo Vs GSK249320 1 mg/kg, Visit 4||10.61|-10.4|
72586269|NCT03777436|144704210|SUPERIORITY||Adjusted difference|27.4|||<|0.0001|TWO_SIDED|95.0|15.4|39.3|||Cochran-Mantel-Haenszel||Adjusted difference is the weighted average of the treatment differences across the strata with the CMH weights. 2-sided 95% CIs based on the stratified Newcombe method. Two-sided p-values were based on the CMH test.|||39.3|15.4|<0.0001
72586270|NCT03777436|144704211|SUPERIORITY||Least squares mean difference|-3.33|STANDARD_ERROR_OF_MEAN|0.942||0.0005|TWO_SIDED|95.0|-5.18|-1.47|||MMRM||Based on MMRM model.|||-1.47|-5.18|0.0005
72586271|NCT03777436|144704212|SUPERIORITY||Least squares mean difference|-2.7|STANDARD_ERROR_OF_MEAN|0.79||0.0008|TWO_SIDED|95.0|-4.2|-1.1|||MMRM||Based on MMRM model.|||-1.1|-4.2|0.0008
72413860|NCT00833989|144336876|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.75|STANDARD_ERROR_OF_MEAN|5.157|||TWO_SIDED|95.0|-7.75|13.26|||Mixed Model Repeated Measures Analysis||Mean difference= GSK249320 5 mg/kg - Placebo Affected Change from Baseline = Treatment + Visit + Treatment \* Visit + Affected Baseline + Unaffected Baseline|Placebo Vs GSK249320 5 mg/kg, Visit 4||13.26|-7.75|
72413861|NCT00833989|144336876|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.85|STANDARD_ERROR_OF_MEAN|5.409|||TWO_SIDED|95.0|-6.17|15.88|||Mixed Model Repeated Measures Analysis||Mean difference= GSK249320 15 mg/kg - Placebo Affected Change from Baseline = Treatment + Visit + Treatment \* Visit + Affected Baseline + Unaffected Baseline|Placebo Vs GSK249320 15 mg/kg, Visit 4||15.88|-6.17|
72413862|NCT00833989|144336876|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.2|STANDARD_ERROR_OF_MEAN|6.504|||TWO_SIDED|95.0|-12.1|14.45|||Mixed Model Repeated Measures Analysis||Mean difference= GSK249320 1 mg/kg - Placebo Affected Change from Baseline = Treatment + Visit + Treatment \* Visit + Affected Baseline + Unaffected Baseline|Placebo Vs GSK249320 1 mg/kg, Visit 5||14.45|-12.1|
72586272|NCT03777436|144704213|SUPERIORITY||Difference|-15.1|STANDARD_ERROR_OF_MEAN|2.6|<|0.0001|TWO_SIDED|95.0|-20.3|-10.0|||MMRM||Based on MMRM model.|||-10.0|-20.3|<0.0001
72586273|NCT00676364|144704237|NON_INFERIORITY_OR_EQUIVALENCE|We determined that we will need to enroll 43 children in each group, for a power of .80, alpha=0.05. We used a per protocol analysis.|Mean Difference (Final Values)|2.1||||0.71|||||||Chi-squared||To assess the association between pain and anxiety with intervention group while controlling for other factors, linear regression was used.|P-value determined from linear regression models that include age, gender, number of needle sticks in previous 2 years and nurse reported difficulty in performing venipuncture.||||0.71
72586274|NCT01342770|144704243|SUPERIORITY_OR_OTHER|||||||0.06|TWO_SIDED||||||Wilcoxon Signed Rank|||||||0.06
72586275|NCT02347774|144704280|SUPERIORITY|A sample size of 215 subjects per treatment would give \~ 90% power to detect a treatment difference of 80 mL in the change from baseline in trough FEV1 at Week 12 between each of the 2 SUN-101 dose groups and placebo at alpha= 0.05, assuming a standard deviation of 255 mL and using a 2-sided test.|Least Mean Squared (SE)|0.0736|STANDARD_ERROR_OF_MEAN|0.01989||0.0002|TWO_SIDED|95.0|0.0346|0.1127|||Least Mean Squared (SE)||In order to control the family-wise Type I error rate, the Hochberg procedure (a tree-structured gatekeeping procedure) was used for comparisons of the primary efficacy endpoints and the key secondary efficacy endpoints.|The change from baseline in trough FEV1 was analyzed using a mixed model repeated measures including terms for treatment, cardiovascular risk, background LABA use, visit week, visit week by treatment interaction, and baseline FEV1 as a covariate. An unstructured covariance matrix was used.||0.1127|0.0346|0.0002
72586276|NCT02347774|144704280|SUPERIORITY|A sample size of 215 subjects per treatment would give \~ 90% power to detect a treatment difference of 80 mL in the change from baseline in trough FEV1 at Week 12 between each of the 2 SUN-101 dose groups and placebo at alpha= 0.05, assuming a standard deviation of 255 mL and using a 2-sided test.|Least Mean Squared (SE)|0.081|STANDARD_ERROR_OF_MEAN|0.02006||0.0001|TWO_SIDED|95.0|0.0416|0.1204|||Least Mean Squared (SE)||In order to control the family-wise Type I error rate, the Hochberg procedure (a tree-structured gatekeeping procedure) was used for comparisons of the primary efficacy endpoints and the key secondary efficacy endpoints.|The change from baseline in trough FEV1 was analyzed using a mixed model repeated measures including terms for treatment, cardiovascular risk, background LABA use, visit week, visit week by treatment interaction, and baseline FEV1 as a covariate. An unstructured covariance matrix was used.||0.1204|0.0416|0.0001
72413863|NCT00833989|144336876|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.05|STANDARD_ERROR_OF_MEAN|6.426|||TWO_SIDED|95.0|-11.0|15.12|||Mixed Model Repeated Measures Analysis||Mean difference= GSK249320 5 mg/kg - Placebo Affected Change from Baseline = Treatment + Visit + Treatment \* Visit + Affected Baseline + Unaffected Baseline|Placebo Vs GSK249320 5 mg/kg, Visit 5||15.12|-11.0|
72413864|NCT00833989|144336876|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.22|STANDARD_ERROR_OF_MEAN|6.82|||TWO_SIDED|95.0|-16.1|11.68|||Mixed Model Repeated Measures Analysis||Mean difference= GSK249320 15 mg/kg - Placebo Affected Change from Baseline = Treatment + Visit + Treatment \* Visit + Affected Baseline + Unaffected Baseline|Placebo Vs GSK249320 15 mg/kg, Visit 5||11.68|-16.1|
72413865|NCT00833989|144336876|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.63|STANDARD_ERROR_OF_MEAN|6.664|||TWO_SIDED|95.0|-12.9|14.18|||Mixed Model Repeated Measures Analysis||Mean difference= GSK249320 1 mg/kg - Placebo Affected Change from Baseline = Treatment + Visit + Treatment \* Visit + Affected Baseline + Unaffected Baseline|Placebo Vs GSK249320 1 mg/kg, Visit 6||14.18|-12.9|
72413866|NCT00833989|144336876|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.03|STANDARD_ERROR_OF_MEAN|6.595||||95.0|-12.4|14.43|||Mixed Model Repeated Measures Analysis||Mean difference= GSK249320 5 mg/kg - Placebo Affected Change from Baseline = Treatment + Visit + Treatment \* Visit + Affected Baseline + Unaffected Baseline|Placebo Vs GSK249320 5 mg/kg, Visit 6||14.43|-12.4|
72413867|NCT00833989|144336876|SUPERIORITY_OR_OTHER||Median Difference (Net)|-0.95|STANDARD_ERROR_OF_MEAN|7.02|||TWO_SIDED|95.0|-15.2|13.32|||Mixed Model Repeated Measures Analysis||Mean difference= GSK249320 15 mg/kg - Placebo Affected Change from Baseline = Treatment + Visit + Treatment \* Visit + Affected Baseline + Unaffected Baseline|Placebo Vs GSK249320 15 mg/kg, Visit 6||13.32|-15.2|
72413868|NCT00833989|144336876|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.25|STANDARD_ERROR_OF_MEAN|6.953|||TWO_SIDED|95.0|-11.9|16.4|||Mixed Model Repeated Measures Analysis||Mean difference= GSK249320 1 mg/kg - Placebo Affected Change from Baseline = Treatment + Visit + Treatment \* Visit + Affected Baseline + Unaffected Baseline|Placebo Vs GSK249320 1 mg/kg, Visit 7||16.40|-11.9|
72413869|NCT00833989|144336876|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.52|STANDARD_ERROR_OF_MEAN|6.909|||TWO_SIDED|95.0|-10.5|17.55|||Mixed Model Repeated Measures Analysis||Mean difference= GSK249320 5 mg/kg - Placebo Affected Change from Baseline = Treatment + Visit + Treatment \* Visit + Affected Baseline + Unaffected Baseline|Placebo Vs GSK249320 5 mg/kg, Visit 7||17.55|-10.5|
72413870|NCT00833989|144336876|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.5|STANDARD_ERROR_OF_MEAN|7.328|||TWO_SIDED|95.0|-15.4|14.39|||Mixed Model Repeated Measures Analysis||Mean difference= GSK249320 15 mg/kg - Placebo Affected Change from Baseline = Treatment + Visit + Treatment \* Visit + Affected Baseline + Unaffected Baseline|Placebo Vs GSK249320 15 mg/kg, Visit 7||14.39|-15.4|
72413871|NCT00833989|144336877|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.66|STANDARD_ERROR_OF_MEAN|3.42|||TWO_SIDED|95.0|-5.33|8.65|||Mixed Model Repeated Measures Analysis||"Mean difference= GSK249320 1 mg/kg - Placebo.~Affected Change from Baseline = Treatment + Visit + Treatment \* Visit + Affected Baseline + Unaffected Baseline"|Placebo Vs GSK249320 1 mg/kg, Visit 4||8.65|-5.33|
72413872|NCT00833989|144336877|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.3|STANDARD_ERROR_OF_MEAN|3.55|||TWO_SIDED|95.0|-7.56|6.96|||Mixed Model Repeated Measures Analysis||"Mean difference= GSK249320 5 mg/kg - Placebo.~Affected Change from Baseline = Treatment + Visit + Treatment \* Visit + Affected Baseline + Unaffected Baseline"|Placebo Vs GSK249320 5 mg/kg, Visit 4||6.96|-7.56|
72413873|NCT00833989|144336877|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.56|STANDARD_ERROR_OF_MEAN|3.534|||TWO_SIDED|95.0|-2.67|11.78|||Mixed Model Repeated Measures Analysis||"Mean difference= GSK249320 15 mg/kg - Placebo.~Affected Change from Baseline = Treatment + Visit + Treatment \* Visit + Affected Baseline + Unaffected Baseline"|Placebo Vs GSK249320 15 mg/kg, Visit 4||11.78|-2.67|
72413874|NCT00833989|144336877|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.05|STANDARD_ERROR_OF_MEAN|3.841|||TWO_SIDED|95.0|-5.78|9.89|||Mixed Model Repeated Measures Analysis||"Mean difference= GSK249320 1 mg/kg - Placebo.~Affected Change from Baseline = Treatment + Visit + Treatment \* Visit + Affected Baseline + Unaffected Baseline"|Placebo Vs GSK249320 1 mg/kg, Visit 5||9.89|-5.78|
72586277|NCT02347774|144704281|SUPERIORITY||Least Mean Squared (SE)|0.082|STANDARD_ERROR_OF_MEAN|0.02055|<|0.0001|TWO_SIDED|95.0|0.0417|0.1224||In order to control the family-wise Type I error rate, the Hochberg procedure (a tree-structured gatekeeping procedure) was used for comparisons of the primary efficacy endpoints and the key secondary efficacy endpoints.|Least Mean Squared (SE)|I||The change from baseline in trough FEV1 was analyzed using a mixed model repeated measures model including terms for treatment, cardiovascular risk, background LABA use, visit week, visit week by treatment interaction, and baseline FEV1 as a covariate. An unstructured covariance matrix was used.||0.1224|0.0417|<0.0001
72413875|NCT00833989|144336877|SUPERIORITY_OR_OTHER||Median Difference (Net)|-2.35|STANDARD_ERROR_OF_MEAN|3.958|||TWO_SIDED|95.0|-10.4|5.72|||Mixed Model Repeated Measures Analysis||"Mean difference= GSK249320 5 mg/kg - Placebo.~Affected Change from Baseline = Treatment + Visit + Treatment \* Visit + Affected Baseline + Unaffected Baseline"|Placebo Vs GSK249320 5 mg/kg, Visit 5||5.72|-10.4|
72586278|NCT02347774|144704281|SUPERIORITY||Least Mean Squared (SE)|0.084|STANDARD_ERROR_OF_MEAN|0.02069||0.0001|TWO_SIDED|95.0|0.0433|0.1246||In order to control the family-wise Type I error rate, the Hochberg procedure (a tree-structured gatekeeping procedure) was used for comparisons of the primary efficacy endpoints and the key secondary efficacy endpoints.|Least Mean Squared (SE)|||The change from baseline in trough FEV1 was analyzed using a mixed model repeated measures model including terms for treatment, cardiovascular risk, background LABA use, visit week, visit week by treatment interaction, and baseline FEV1 as a covariate. An unstructured covariance matrix was used.||0.1246|0.0433|0.0001
72586279|NCT00921557|144704296|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||Not adjusted for multiple comparisons.|Wilcoxon (Mann-Whitney)|||Comparison of percent change from baseline to week 24||||<0.001
72586280|NCT00921557|144704296|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||Not adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|||Comparison of percent change from baseline to week 48||||<0.001
72586281|NCT00921557|144704297|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.99||||||Not adjusted for multiple comparisons|Fisher Exact|||Comparison of percentage of participants experiencing primary safety outcome||||>0.99
72586282|NCT04157296|144704324|SUPERIORITY||Mean Difference (Final Values)|-0.226|||||TWO_SIDED|||||||||leftIFG (Change in Brain activity \[post minus pre\])||||
72586283|NCT04157296|144704324|SUPERIORITY||Median Difference (Final Values)|-0.309|||||TWO_SIDED|||||||||rightIFG (Change in Brain activity \[post minus pre\])||||
72586284|NCT04157296|144704324|SUPERIORITY||Mean Difference (Final Values)|-0.179|||||TWO_SIDED|||||||||leftParietal (Change in Brain activity \[post minus pre\])||||
72586285|NCT04157296|144704324|SUPERIORITY||Mean Difference (Final Values)|0.324|||||TWO_SIDED|||||||||rightParietal (Change in Brain activity \[post minus pre\])||||
72586286|NCT04157296|144704324|SUPERIORITY||Mean Difference (Final Values)|0.41|||||TWO_SIDED|||||||||leftdACC (Change in Brain activity \[post minus pre\])||||
72586287|NCT04157296|144704324|SUPERIORITY||Mean Difference (Final Values)|-0.067|||||TWO_SIDED|||||||||rightdACC (Change in Brain activity \[post minus pre\])||||
72586288|NCT04157296|144704324|SUPERIORITY||Mean Difference (Final Values)|0.302|||||TWO_SIDED|||||||||leftInsula (Change in Brain activity \[post minus pre\])||||
72586289|NCT04157296|144704324|SUPERIORITY|rightInsula (Change in Brain activity \[post minus pre\])|Mean Difference (Final Values)|0.234|||||TWO_SIDED|||||||||rightInsula (Change in Brain activity \[post minus pre\])||||
72586290|NCT04157296|144704324|SUPERIORITY||Mean Difference (Final Values)|-0.04|||||TWO_SIDED|||||||||TCN (Change in Connectivity \[post minus pre\])||||
72586291|NCT04157296|144704325|SUPERIORITY|||||||0.241|||||||t-test, 1 sided|||||||0.241
72586292|NCT04157296|144704326|SUPERIORITY|||||||0.233|||||||t-test, 1 sided|||||||0.233
72586293|NCT04157296|144704327|SUPERIORITY|||||||0.042|||||||t-test, 1 sided|||||||0.042
72586294|NCT04157296|144704328|SUPERIORITY|||||||0.349|||||||t-test, 1 sided|||||||0.349
72586295|NCT01422889|144704429|SUPERIORITY_OR_OTHER||percentage|2.2|||||TWO_SIDED|||||A p-value was not calculated for the ION Registry 12 month cardiac events. For the protocol specified primary endpoint analysis including data pooled from the PERSEUS SV, PERSEUS WH and TE Prove patient populations please see the citations.||||2.2% (23/1028) of ION Registry subjects experienced CD/MI related to the ION stent at 12 months||||
72586296|NCT01422889|144704430|SUPERIORITY_OR_OTHER||percentage|2.6|||||ONE_SIDED|||||A p-value was not calculated for the ION Registry 2 year cardiac events. For the protocol specified secondary endpoint analysis including data pooled from the PERSEUS SV, PERSEUS WH and TE Prove patient populations please see the citations.||||2.6% (27/1054) of ION Registry subjects experienced ARC ST Definite/Probable related to the ION stent at 2 years.||||
72586297|NCT01757184|144704459|SUPERIORITY|||||||0.0271|||||||Fisher Exact|Fisher's exact test at α=0.05.||A sample size of 50 randomized participants (approximately 25 participants per treatment group) provided 97% power to detect a statistically significant difference between sebelipase alfa and placebo, using Fisher's exact test at α=0.05.||||0.0271
72586298|NCT01757184|144704460|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
72586299|NCT01757184|144704461|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
72586300|NCT01757184|144704462|SUPERIORITY|||||||0.0003|||||||Fisher Exact|||||||0.0003
72586301|NCT01757184|144704463|SUPERIORITY|||||||0.0375|||||||Wilcoxon (Mann-Whitney)|||||||0.0375
72586302|NCT01757184|144704464|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
72586303|NCT01757184|144704465|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
72586304|NCT01757184|144704466|SUPERIORITY|||||||0.4216|||||||Fisher Exact|||||||0.4216
72586305|NCT01757184|144704467|SUPERIORITY|||||||0.0068|||||||Wilcoxon (Mann-Whitney)|||||||0.0068
72586306|NCT01554527|144704481|SUPERIORITY|||||||0.07|||||||t-test, 2 sided|||Intent to treat for controls vs. treatment (adherent/non-adherent)||||0.07
72586307|NCT01554527|144704482|SUPERIORITY|||||||0.34|||||||t-test, 2 sided|||Intent to treat for controls vs. treatment (adherent/non-adherent)||||0.34
72586308|NCT01554527|144704483|SUPERIORITY|||||||0.93|||||||t-test, 2 sided|||Intent to treat for controls vs. treatment (adherent/non-adherent)||||0.93
72586309|NCT01554527|144704484|SUPERIORITY|||||||0.5|||||||t-test, 2 sided|||Intent to treat for controls vs. treatment (adherent/non-adherent)||||0.5
72586310|NCT01554527|144704485|SUPERIORITY|||||||0.25|||||||t-test, 2 sided|||Intent to treat for controls vs. treatment (adherent/non-adherent)||||0.25
72586311|NCT01052480|144704489|SUPERIORITY_OR_OTHER|||||||0.069|||||||Log Rank|||||||0.069
72413876|NCT00833989|144336877|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.44|STANDARD_ERROR_OF_MEAN|3.978|||TWO_SIDED|95.0|-6.68|9.55|||Mixed Model Repeated Measures Analysis||"Mean difference= GSK249320 15 mg/kg - Placebo.~Affected Change from Baseline = Treatment + Visit + Treatment \* Visit + Affected Baseline + Unaffected Baseline"|Placebo Vs GSK249320 15 mg/kg, Visit 5||9.55|-6.68|
72413877|NCT00833989|144336877|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.46|STANDARD_ERROR_OF_MEAN|4.109|||TWO_SIDED|95.0|-4.94|11.85|||Mixed Model Repeated Measures Analysis||"Mean difference= GSK249320 1 mg/kg - Placebo.~Affected Change from Baseline = Treatment + Visit + Treatment \* Visit + Affected Baseline + Unaffected Baseline"|Placebo Vs GSK249320 1 mg/kg, Visit 6||11.85|-4.94|
72413878|NCT00833989|144336877|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.49|STANDARD_ERROR_OF_MEAN|4.235|||TWO_SIDED|95.0|-8.15|9.12|||Mixed Model Repeated Measures Analysis||"Mean difference= GSK249320 5 mg/kg - Placebo.~Affected Change from Baseline = Treatment + Visit + Treatment \* Visit + Affected Baseline + Unaffected Baseline"|Placebo Vs GSK249320 5 mg/kg, Visit 6||9.12|-8.15|
72413879|NCT00833989|144336877|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.77|STANDARD_ERROR_OF_MEAN|4.28|||TWO_SIDED|95.0|-7.97|9.5|||Mixed Model Repeated Measures Analysis||"Mean difference= GSK249320 15 mg/kg - Placebo.~Affected Change from Baseline = Treatment + Visit + Treatment \* Visit + Affected Baseline + Unaffected Baseline"|Placebo Vs GSK249320 15 mg/kg, Visit 6||9.50|-7.97|
72413880|NCT00833989|144336877|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.04|STANDARD_ERROR_OF_MEAN|4.205|||TWO_SIDED|95.0|-5.53|11.61|||Mixed Model Repeated Measures Analysis||"Mean difference= GSK249320 1 mg/kg - Placebo.~Affected Change from Baseline = Treatment + Visit + Treatment \* Visit + Affected Baseline + Unaffected Baseline"|Placebo Vs GSK249320 1 mg/kg, Visit 7||11.61|-5.53|
72413881|NCT00833989|144336877|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.58|STANDARD_ERROR_OF_MEAN|4.376|||TWO_SIDED|95.0|-11.5|6.32|||Mixed Model Repeated Measures Analysis||"Mean difference= GSK249320 5 mg/kg - Placebo.~Affected Change from Baseline = Treatment + Visit + Treatment \* Visit + Affected Baseline + Unaffected Baseline"|Placebo Vs GSK249320 5 mg/kg, Visit 7||6.32|-11.5|
72586312|NCT00529373|144704511|OTHER||Hazard Ratio (HR)|0.46|||<|0.001|TWO_SIDED|95.0|0.4|0.53|||Generalized linear model|||Odanacatib 50 mg OW vs Placebo. Generalized linear model for binary data with cloglog link and terms for time interval, treatment, stratum, and geographic region. cloglog link = complementary log log transformation of probability of an event up to the time-point.||0.53|0.40|<0.001
72586313|NCT00529373|144704512|OTHER||Hazard Ratio (HR)|0.53|||<|0.001|TWO_SIDED|95.0|0.39|0.71|||Regression, Cox|||Odanacatib 50 mg OW vs Placebo. The Cox proportional hazards model included terms for treatment, stratum and geographic region.||0.71|0.39|<0.001
72413882|NCT00833989|144336877|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.73|STANDARD_ERROR_OF_MEAN|4.396|||TWO_SIDED|95.0|-5.22|12.69|||Mixed Model Repeated Measures Analysis||"Mean difference= GSK249320 15 mg/kg - Placebo.~Affected Change from Baseline = Treatment + Visit + Treatment \* Visit + Affected Baseline + Unaffected Baseline"|Placebo Vs GSK249320 15 mg/kg, Visit 7||12.69|-5.22|
72413883|NCT00833989|144336878|SUPERIORITY_OR_OTHER|||||||0.926|||||||Fisher Exact|||Visit 4||||0.9260
72413884|NCT00833989|144336878|SUPERIORITY_OR_OTHER|||||||0.5647|||||||Fisher Exact|||Visit 6||||0.5647
72413885|NCT00833989|144336879|SUPERIORITY_OR_OTHER||Median Difference (Net)|-1.34|STANDARD_ERROR_OF_MEAN|0.896|||TWO_SIDED|95.0|-3.17|0.49|||Mixed Model Repeated Measures Analysis||Mean difference= GSK249320 1 mg/kg - Placebo Change from Baseline = Treatment + Visit + Treatment \* Visit + Baseline|Placebo Vs GSK249320 1 mg/kg, Visit 3||0.49|-3.17|
72413886|NCT00833989|144336879|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.19|STANDARD_ERROR_OF_MEAN|0.861|||TWO_SIDED|95.0|-1.95|1.57|||Mixed Model Repeated Measures Analysis||Mean difference= GSK249320 5 mg/kg - Placebo Change from Baseline = Treatment + Visit + Treatment \* Visit + Baseline|Placebo Vs GSK249320 5 mg/kg, Visit 3||1.57|-1.95|
72413887|NCT00833989|144336879|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.92|STANDARD_ERROR_OF_MEAN|0.933|||TWO_SIDED|95.0|-4.83|-1.02|||Mixed Model Repeated Measures Analysis||Mean difference= GSK249320 15 mg/kg - Placebo Change from Baseline = Treatment + Visit + Treatment \* Visit + Baseline|Placebo Vs GSK249320 15 mg/kg, Visit 3||-1.02|-4.83|
72413888|NCT00833989|144336879|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.7|STANDARD_ERROR_OF_MEAN|0.868|||TWO_SIDED|95.0|-2.47|1.08|||Mixed Model Repeated Measures Analysis||Mean difference= GSK249320 1 mg/kg - Placebo Change from Baseline = Treatment + Visit + Treatment \* Visit + Baseline|Placebo Vs GSK249320 1 mg/kg, Visit 4||1.08|-2.47|
72413889|NCT00833989|144336879|SUPERIORITY_OR_OTHER||Median Difference (Net)|-0.27|STANDARD_ERROR_OF_MEAN|0.834|||TWO_SIDED|95.0|-1.98|1.44|||Mixed Model Repeated Measures Analysis||Mean difference= GSK249320 5 mg/kg - Placebo Change from Baseline = Treatment + Visit + Treatment \* Visit + Baseline|Placebo Vs GSK249320 5 mg/kg, Visit 4||1.44|-1.98|
72586314|NCT00529373|144704513|OTHER||Hazard Ratio (HR)|0.77|||<|0.001|TWO_SIDED|95.0|0.68|0.87|||Regression, Cox|||Odanacatib 50 mg OW vs Placebo. The Cox proportional hazards model included terms for treatment, stratum and geographic region.||0.87|0.68|<0.001
72586315|NCT00529373|144704514|OTHER||Hazard Ratio (HR)|0.48|||<|0.001|TWO_SIDED|95.0|0.42|0.55|||Generalized linear model|||Odanacatib 50 mg OW vs Placebo. Generalized linear model for binary data with cloglog link and terms for time interval, treatment, stratum, and geographic region. cloglog link = complementary log log transformation of probability of an event up to the time-point.||0.55|0.42|<0.001
72586316|NCT00529373|144704515|OTHER||Hazard Ratio (HR)|0.52|||<|0.001|TWO_SIDED|95.0|0.4|0.67|||Regression, Cox|||Odanacatib 50 mg OW vs Placebo. The Cox proportional hazards model included terms for treatment, stratum and geographic region.||0.67|0.40|<0.001
72586317|NCT00529373|144704516|OTHER||Hazard Ratio (HR)|0.74|||<|0.001|TWO_SIDED|95.0|0.66|0.83|||Regression, Cox|||Odanacatib 50 mg OW vs Placebo. The Cox proportional hazards model included terms for treatment, stratum and geographic region.||0.83|0.66|<0.001
72586318|NCT00529373|144704517|OTHER|Miettinen \& Nurminen|Difference in rates|0.88|||||TWO_SIDED|95.0|-2.3|4.07||||||||4.07|-2.3|
72586319|NCT00529373|144704518|OTHER|Miettinen \& Nurminen|Difference in rates|0.11|||||TWO_SIDED|95.0|-0.16|0.37||||||||0.37|-0.16|
72586320|NCT00529373|144704522|OTHER||Difference in Least Squares Means|8.92|||<|0.001|TWO_SIDED|95.0|3.9|13.93|||Longitudinal model|||Odanacatib 50 mg vs Placebo||13.93|3.9|<0.001
72586321|NCT00529373|144704523|OTHER||Difference in Least Squares Means|26.45|||<|0.001|TWO_SIDED|95.0|16.49|36.4|||Longitudinal model|||Odanacatib 50 mg vs Placebo||36.40|16.49|<0.001
72586322|NCT00529373|144704524|OTHER||Mean Difference (Final Values)|-0.02|||||TWO_SIDED|95.0|-0.14|0.09||||||Odanacatib 50 mg OW - Placebo at Month 12. Longitudinal model includes terms for treatment, stratum (sarcopenia, non-sarcopenia), time and interaction between treatment and time as fixed effects (LS means weighted for stratum size).||0.09|-0.14|
72586323|NCT00529373|144704524|OTHER||Mean Difference (Final Values)|0.0|||||TWO_SIDED|95.0|-0.12|0.12||||||Odanacatib 50 mg OW - Placebo at Month 24. Longitudinal model includes terms for treatment, stratum (sarcopenia, non-sarcopenia), time and interaction between treatment and time as fixed effects (LS means weighted for stratum size).||0.12|-0.12|
72586324|NCT00529373|144704524|OTHER||Mean Difference (Final Values)|-0.04|||||TWO_SIDED|95.0|-0.17|0.09||||||Odanacatib 50 mg OW - Placebo at Month 36. Longitudinal model includes terms for treatment, stratum (sarcopenia, non-sarcopenia), time and interaction between treatment and time as fixed effects (LS means weighted for stratum size).||0.09|-0.17|
72586325|NCT00529373|144704524|OTHER||Mean Difference (Final Values)|-0.21|||||TWO_SIDED|95.0|-0.5|0.08||||||Odanacatib 50 mg OW - Placebo at Month 48. Longitudinal model includes terms for treatment, stratum (sarcopenia, non-sarcopenia), time and interaction between treatment and time as fixed effects (LS means weighted for stratum size).||0.08|-0.50|
72586326|NCT00529373|144704525|OTHER||Difference in Least Squares Means|0.11|||||TWO_SIDED|95.0|-0.16|0.38||||||Odanacatib 50 mg OW - Placebo at Month 12. Longitudinal model includes terms for treatment, stratum (sarcopenia, non-sarcopenia), time and interaction between treatment and time as fixed effects (LS means weighted for stratum size).||0.38|-0.16|
72586327|NCT00529373|144704525|OTHER||Difference in Least Squares Means|0.14|||||TWO_SIDED|95.0|-0.15|0.44||||||Odanacatib 50 mg OW - Placebo at Month 24. Longitudinal model includes terms for treatment, stratum (sarcopenia, non-sarcopenia), time and interaction between treatment and time as fixed effects (LS means weighted for stratum size).||0.44|-0.15|
72586328|NCT00529373|144704525|OTHER||Difference in Least Squares Means|0.19|||||TWO_SIDED|95.0|-0.15|0.54||||||Odanacatib 50 mg OW - Placebo at Month 36. Longitudinal model includes terms for treatment, stratum (sarcopenia, non-sarcopenia), time and interaction between treatment and time as fixed effects (LS means weighted for stratum size).||0.54|-0.15|
72586329|NCT00529373|144704525|OTHER||Difference in Least Squares Means|0.19|||||TWO_SIDED|95.0|-0.24|0.62||||||Odanacatib 50 mg OW - Placebo at Month 48. Longitudinal model includes terms for treatment, stratum (sarcopenia, non-sarcopenia), time and interaction between treatment and time as fixed effects (LS means weighted for stratum size).||0.62|-0.24|
72413890|NCT00833989|144336879|SUPERIORITY_OR_OTHER||Median Difference (Net)|-0.92|STANDARD_ERROR_OF_MEAN|0.904|||TWO_SIDED|95.0|-2.77|0.92|||Mixed Model Repeated Measures Analysis||Mean difference= GSK249320 15 mg/kg - Placebo Change from Baseline = Treatment + Visit + Treatment \* Visit + Baseline|Placebo Vs GSK249320 15 mg/kg, Visit 4||0.92|-2.77|
72586330|NCT00529373|144704526|OTHER||Difference in Least Squares Means|0.04|||||TWO_SIDED|95.0|-0.08|0.15||||||Odanacatib 50 mg OW - Placebo at Month 12. Longitudinal model includes terms for treatment, stratum (sarcopenia, non-sarcopenia), time and interaction between treatment and time as fixed effects (LS means weighted for stratum size).||0.15|-0.08|
72586331|NCT00529373|144704526|OTHER||Difference in Least Squares Means|0.08|||||TWO_SIDED|95.0|-0.06|0.21||||||Odanacatib 50 mg OW - Placebo at Month 24. Longitudinal model includes terms for treatment, stratum (sarcopenia, non-sarcopenia), time and interaction between treatment and time as fixed effects (LS means weighted for stratum size).||0.21|-0.06|
72586332|NCT00529373|144704526|OTHER||Difference in Least Squares Means|0.03|||||TWO_SIDED|95.0|-0.12|0.17||||||Odanacatib 50 mg OW - Placebo at Month 36. Longitudinal model includes terms for treatment, stratum (sarcopenia, non-sarcopenia), time and interaction between treatment and time as fixed effects (LS means weighted for stratum size).||0.17|-0.12|
72586333|NCT00529373|144704526|OTHER||Difference in Least Squares Means|0.09|||||TWO_SIDED|95.0|-0.09|0.28||||||Odanacatib 50 mg OW - Placebo at Month 48. Longitudinal model includes terms for treatment, stratum (sarcopenia, non-sarcopenia), time and interaction between treatment and time as fixed effects (LS means weighted for stratum size).||0.28|-0.09|
72586334|NCT00529373|144704527|OTHER|Miettinen \& Nurminen|Difference in rates|1.52|||||TWO_SIDED|95.0|-1.8|4.84||||||||4.84|-1.8|
72586335|NCT00529373|144704528|OTHER|Miettinen \& Nurminen|Difference in rates|0.27|||||TWO_SIDED|95.0|-0.04|0.58||||||||0.58|-0.04|
72586336|NCT00529373|144704529|OTHER||Hazard Ratio (HR)|0.28|||<|0.001|TWO_SIDED|95.0|0.19|0.4|||Regression, Cox|||Odanacatib 50 mg OW vs Placebo. The Cox proportional hazards model included terms for treatment, stratum and geographic region.||0.40|0.19|<0.001
72586337|NCT00529373|144704530|OTHER||Difference in Least Squares Means|0.01||||0.041|TWO_SIDED|95.0|0.0|0.03|||Mixed Models Analysis|||Odanacatib 50 mg OW versus Placebo. The mixed model contained fixed effects for treatment, region, stratum, treatment-year interaction and random effect intercept and slope (year) and unstructured covariance matrix.||0.03|0.00|0.041
72586338|NCT00529373|144704531|OTHER||Odds Ratio (OR)|0.89||||0.014|TWO_SIDED|95.0|0.81|0.98|||Logistic model|||Odanacatib 50 mg OW versus Placebo. Treatment comparison for height loss at any time during the treatment period. The logistic model contained terms for treatment, geographic region and stratum.||0.98|0.81|0.014
72586339|NCT00529373|144704532|OTHER||Difference in Least Squares Means|1.32|||<|0.001|TWO_SIDED|95.0|0.9|1.75|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 6. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||1.75|0.90|<0.001
72586340|NCT00529373|144704532|OTHER||Difference in Least Squares Means|2.49|||<|0.001|TWO_SIDED|95.0|2.37|2.61|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 12. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||2.61|2.37|<0.001
72586341|NCT00529373|144704532|OTHER||Difference in Least Squares Means|4.47|||<|0.001|TWO_SIDED|95.0|4.31|4.62|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 24. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||4.62|4.31|<0.001
72586342|NCT00529373|144704532|OTHER||Difference in Least Squares Means|6.44|||<|0.001|TWO_SIDED|95.0|6.25|6.64|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 36. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||6.64|6.25|<0.001
72586343|NCT00529373|144704532|OTHER||Difference in Least Squares Means|8.62|||<|0.001|TWO_SIDED|95.0|8.11|9.12|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 48. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||9.12|8.11|<0.001
72413891|NCT00833989|144336879|SUPERIORITY_OR_OTHER||Median Difference (Net)|-1.03|STANDARD_ERROR_OF_MEAN|1.278|||TWO_SIDED|95.0|-3.64|1.57|||Mixed Model Repeated Measures Analysis||Mean difference= GSK249320 1 mg/kg - Placebo Change from Baseline = Treatment + Visit + Treatment \* Visit + Baseline|Placebo Vs GSK249320 1 mg/kg, Visit 6||1.57|-3.64|
72586344|NCT00529373|144704532|OTHER||Difference in Least Squares Means|9.49|||<|0.001|TWO_SIDED|95.0|8.7|10.29|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 60. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||10.29|8.70|<0.001
72586345|NCT00529373|144704533|OTHER||Difference in Least Squares Means|2.96|||<|0.001|TWO_SIDED|95.0|2.47|3.46|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 6. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||3.46|2.47|<0.001
72586346|NCT00529373|144704533|OTHER||Difference in Least Squares Means|4.07|||<|0.001|TWO_SIDED|95.0|3.93|4.22|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 12. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||4.22|3.93|<0.001
72586347|NCT00529373|144704533|OTHER||Difference in Least Squares Means|6.05|||<|0.001|TWO_SIDED|95.0|5.87|6.23|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 24. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||6.23|5.87|<0.001
72586348|NCT00529373|144704533|OTHER||Difference in Least Squares Means|7.84|||<|0.001|TWO_SIDED|95.0|7.62|8.06|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 36. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||8.06|7.62|<0.001
72586349|NCT00529373|144704533|OTHER||Difference in Least Squares Means|9.72|||<|0.001|TWO_SIDED|95.0|9.16|10.27|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 48. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||10.27|9.16|<0.001
72586350|NCT00529373|144704533|OTHER||Difference in Least Squares Means|11.23|||<|0.001|TWO_SIDED|95.0|10.23|12.23|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 60. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||12.23|10.23|<0.001
72586351|NCT00529373|144704534|OTHER||Difference in Least Squares Means|1.49|||<|0.001|TWO_SIDED|95.0|0.95|2.03|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 6. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||2.03|0.95|<0.001
72586352|NCT00529373|144704534|OTHER||Difference in Least Squares Means|2.21|||<|0.001|TWO_SIDED|95.0|2.05|2.37|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 12. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||2.37|2.05|<0.001
72586353|NCT00529373|144704534|OTHER||Difference in Least Squares Means|4.38|||<|0.001|TWO_SIDED|95.0|4.19|4.57|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 24. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||4.57|4.19|<0.001
72413892|NCT00833989|144336879|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.37|STANDARD_ERROR_OF_MEAN|1.278|||TWO_SIDED|95.0|-2.97|2.24|||Mixed Model Repeated Measures Analysis||Mean difference= GSK249320 5 mg/kg - Placebo Change from Baseline = Treatment + Visit + Treatment \* Visit + Baseline|Placebo Vs GSK249320 5 mg/kg, Visit 6||2.24|-2.97|
72586354|NCT00529373|144704534|OTHER||Difference in Least Squares Means|6.46|||<|0.001|TWO_SIDED|95.0|6.24|6.68|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 36. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||6.68|6.24|<0.001
72586355|NCT00529373|144704534|OTHER||Difference in Least Squares Means|8.42|||<|0.001|TWO_SIDED|95.0|7.82|9.02|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 48. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||9.02|7.82|<0.001
72586356|NCT00529373|144704534|OTHER||Difference in Least Squares Means|8.53|||<|0.001|TWO_SIDED|95.0|7.54|9.53|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 60. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||9.53|7.54|<0.001
72586357|NCT00529373|144704535|OTHER||Difference in Least Squares Means|1.74|||<|0.001|TWO_SIDED|95.0|1.03|2.46|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 6. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||2.46|1.03|<0.001
72586358|NCT00529373|144704535|OTHER||Difference in Least Squares Means|3.5|||<|0.001|TWO_SIDED|95.0|3.31|3.7|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 12. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||3.70|3.31|<0.001
72413893|NCT00833989|144336879|SUPERIORITY_OR_OTHER||Median Difference (Net)|-0.37|STANDARD_ERROR_OF_MEAN|2.21|||TWO_SIDED|95.0|-0.66|1.408|||Mixed Model Repeated Measures Analysis||Mean difference= GSK249320 15 mg/kg - Placebo Change from Baseline = Treatment + Visit + Treatment \* Visit + Baseline|Placebo Vs GSK249320 15 mg/kg, Visit 6||1.408|-0.66|
72586359|NCT00529373|144704535|OTHER||Difference in Least Squares Means|6.41|||<|0.001|TWO_SIDED|95.0|6.17|6.65|||Longitudinal model|Includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size)||Odanacatib 50 mg OW - Placebo at Month 24||6.65|6.17|<0.001
72586360|NCT00529373|144704535|OTHER||Difference in Least Squares Means|9.27|||<|0.001|TWO_SIDED|95.0|8.98|9.57|||Longitudinal model|Includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size)||Odanacatib 50 mg OW - Placebo at Month 36||9.57|8.98|<0.001
72586361|NCT00529373|144704535|OTHER||Difference in Least Squares Means|12.44|||<|0.001|TWO_SIDED|95.0|11.66|13.22|||Longitudinal model|Includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size)||Odanacatib 50 mg OW - Placebo at Month 48||13.22|11.66|<0.001
72586362|NCT00529373|144704535|OTHER||Difference in Least Squares Means|13.81|||<|0.001|TWO_SIDED|95.0|12.58|15.04|||Longitudinal model|Includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size)||Odanacatib 50 mg OW - Placebo at Month 60||15.04|12.58|<0.001
72586363|NCT00529373|144704536|OTHER||Difference in Least Squares Means|1.11|||<|0.001|TWO_SIDED|95.0|0.67|1.55|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 12. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||1.55|0.67|<0.001
72586364|NCT00529373|144704536|OTHER||Difference in Least Squares Means|1.35|||<|0.001|TWO_SIDED|95.0|0.85|1.84|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 24. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||1.84|0.85|<0.001
72586365|NCT00529373|144704536|OTHER||Difference in Least Squares Means|1.93|||<|0.001|TWO_SIDED|95.0|1.38|2.47|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 36. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||2.47|1.38|<0.001
72586366|NCT00529373|144704536|OTHER||Difference in Least Squares Means|2.2||||0.001|TWO_SIDED|95.0|0.89|3.51|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 48. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||3.51|0.89|0.001
72586367|NCT00529373|144704536|OTHER||Difference in Least Squares Means|3.5||||0.001|TWO_SIDED|95.0|1.46|5.54|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 60. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||5.54|1.46|0.001
72586368|NCT00529373|144704537|OTHER||Difference in Least Squares Means|5.79|||<|0.001|TWO_SIDED|95.0|5.37|6.2|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 12. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||6.2|5.37|<0.001
72586369|NCT00529373|144704537|OTHER||Difference in Least Squares Means|4.02|||<|0.001|TWO_SIDED|95.0|3.67|4.37|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 24. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||4.37|3.67|<0.001
72586370|NCT00529373|144704537|OTHER||Difference in Least Squares Means|7.62|||<|0.001|TWO_SIDED|95.0|7.11|8.13|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 36. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||8.13|7.11|<0.001
72586371|NCT00529373|144704537|OTHER||Difference in Least Squares Means|9.51|||<|0.001|TWO_SIDED|95.0|7.96|11.06|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 48. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||11.06|7.96|<0.001
72413894|NCT00833989|144336880|SUPERIORITY_OR_OTHER||Mean Difference (Net)|19.46|STANDARD_ERROR_OF_MEAN|12.584|||TWO_SIDED|95.0|-6.11|45.04|||Mixed Model Repeated Measures Analysis||Mean difference= GSK249320 1 mg/kg - Placebo Barthel Total Score= Treatment + Visit + Treatment \*Visit|Placebo Vs GSK249320 1 mg/kg, Visit 4||45.04|-6.11|
72586372|NCT00529373|144704538|OTHER||Difference in Least Squares Means|2.4|||<|0.001|TWO_SIDED|95.0|2.11|2.68|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 12. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||2.68|2.11|<0.001
72586373|NCT00529373|144704538|OTHER||Difference in Least Squares Means|4.21|||<|0.001|TWO_SIDED|95.0|3.84|4.57|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 24. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||4.57|3.84|<0.001
72586374|NCT00529373|144704538|OTHER||Difference in Least Squares Means|5.86|||<|0.001|TWO_SIDED|95.0|5.41|6.3|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 36. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||6.30|5.41|<0.001
72586375|NCT00529373|144704538|OTHER||Difference in Least Squares Means|8.54|||<|0.001|TWO_SIDED|95.0|7.0|10.09|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 48. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||10.09|7.00|<0.001
72586376|NCT00529373|144704539|OTHER||Difference in Least Squares Means|2.21|||<|0.001|TWO_SIDED|95.0|1.83|2.59|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 12. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||2.59|1.83|<0.001
72586377|NCT00529373|144704539|OTHER||Difference in Least Squares Means|4.33|||<|0.001|TWO_SIDED|95.0|3.87|4.78|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 24. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||4.78|3.87|<0.001
72586378|NCT00529373|144704539|OTHER||Difference in Least Squares Means|6.09|||<|0.001|TWO_SIDED|95.0|5.56|6.62|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 36. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||6.62|5.56|<0.001
72586379|NCT00529373|144704539|OTHER||Difference in Least Squares Means|9.08|||<|0.001|TWO_SIDED|95.0|6.97|11.19|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 48. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||11.19|6.97|<0.001
72586380|NCT00529373|144704540|OTHER||Difference in Least Squares Means|3.44|||<|0.001|TWO_SIDED|95.0|2.98|3.9|||Longitudinal model|Includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size)||Odanacatib 50 mg OW - Placebo at Month 12||3.90|2.98|<0.001
72586381|NCT00529373|144704540|OTHER||Difference in Least Squares Means|6.03|||<|0.001|TWO_SIDED|95.0|5.47|6.59|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 24. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||6.59|5.47|<0.001
72586382|NCT00529373|144704540|OTHER||Difference in Least Squares Means|8.49|||<|0.001|TWO_SIDED|95.0|7.81|9.16|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 36. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||9.16|7.81|<0.001
72586383|NCT00529373|144704540|OTHER||Difference in Least Squares Means|11.76|||<|0.001|TWO_SIDED|95.0|9.15|14.36|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 48. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||14.36|9.15|<0.001
72586384|NCT00529373|144704541|OTHER||Difference in Least Squares Means|1.08||||0.083|TWO_SIDED|95.0|-0.14|2.31|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 12. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||2.31|-0.14|0.083
72586385|NCT00529373|144704541|OTHER||Difference in Least Squares Means|1.05||||0.129|TWO_SIDED|95.0|-0.31|2.4|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 24. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||2.40|-0.31|0.129
72586386|NCT00529373|144704541|OTHER||Difference in Least Squares Means|1.21||||0.104|TWO_SIDED|95.0|-0.25|2.67|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 36. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||2.67|-0.25|0.104
72586387|NCT00529373|144704541|OTHER||Difference in Least Squares Means|1.55||||0.617|TWO_SIDED|95.0|-4.92|8.02|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 48. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||8.02|-4.92|0.617
72586388|NCT00529373|144704542|OTHER||Difference in Least Squares Means|-58.99|||<|0.001|TWO_SIDED|95.0|-64.68|-53.3|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 6.||-53.30|-64.68|<0.001
72586389|NCT00529373|144704542|OTHER||Difference in Least Squares Means|-60.01|||<|0.001|TWO_SIDED|95.0|-66.4|-53.61|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 12.||-53.61|-66.40|<0.001
72586390|NCT00529373|144704542|OTHER||Difference in Least Squares Means|-46.7|||<|0.001|TWO_SIDED|95.0|-53.23|-40.17|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 24.||-40.17|-53.23|<0.001
72586391|NCT00529373|144704542|OTHER||Difference in Least Squares Means|-44.67||||0.05|TWO_SIDED|95.0|-52.62|-36.72|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 36.||-36.72|-52.62|0.050
72586392|NCT00529373|144704542|OTHER||Difference in Least Squares Means|-18.73||||0.05|TWO_SIDED|95.0|-37.44|-0.01|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 48.||-0.01|-37.44|0.050
72586393|NCT00529373|144704543|OTHER||Difference in Least Squares Means|-51.7|||<|0.001|TWO_SIDED|95.0|-56.11|-47.28|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 6.||-47.28|-56.11|<0.001
72586394|NCT00529373|144704543|OTHER||Difference in Least Squares Means|-53.59|||<|0.001|TWO_SIDED|95.0|-58.39|-48.79|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 12.||-48.79|-58.39|<0.001
72586395|NCT00529373|144704543|OTHER||Difference in Least Squares Means|-56.68|||<|0.001|TWO_SIDED|95.0|-62.52|-50.84|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 24.||-50.84|-62.52|<0.001
72586396|NCT00529373|144704543|OTHER||Difference in Least Squares Means|-59.14|||<|0.001|TWO_SIDED|95.0|-66.04|-52.23|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 36.||-52.23|-66.04|<0.001
72586397|NCT00529373|144704543|OTHER||Difference in Least Squares Means|-44.54|||<|0.001|TWO_SIDED|95.0|-61.72|-27.36|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 48.||-27.36|-61.72|<0.001
72586398|NCT00529373|144704544|OTHER||Mean Difference (Final Values)|-14.13|||<|0.001|TWO_SIDED|95.0|-17.0|-11.27|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 6. Longitudinal model includes terms for treatment, stratum, region and interaction between treatment and time as fixed effects (LS Means weighted for region and stratum size).||-11.27|-17.00|<0.001
72586399|NCT00529373|144704544|OTHER||Mean Difference (Final Values)|-12.01|||<|0.001|TWO_SIDED|95.0|-15.22|-8.79|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 12. Longitudinal model includes terms for treatment, stratum, region and interaction between treatment and time as fixed effects (LS Means weighted for region and stratum size).||-8.79|-15.22|<0.001
72586400|NCT00529373|144704544|OTHER||Mean Difference (Final Values)|-9.29|||<|0.001|TWO_SIDED|95.0|-13.45|-5.13|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 24. Longitudinal model includes terms for treatment, stratum, region and interaction between treatment and time as fixed effects (LS Means weighted for region and stratum size).||-5.13|-13.45|<0.001
72586401|NCT00529373|144704544|OTHER||Mean Difference (Final Values)|-7.64|||<|0.001|TWO_SIDED|95.0|-11.87|-3.41|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 36. Longitudinal model includes terms for treatment, stratum, region and interaction between treatment and time as fixed effects (LS Means weighted for region and stratum size).||-3.41|-11.87|<0.001
72413895|NCT00833989|144336880|SUPERIORITY_OR_OTHER||Mean Difference (Net)|20.99|STANDARD_ERROR_OF_MEAN|12.131|||TWO_SIDED|95.0|-3.66|45.64|||Mixed Model Repeated Measures Analysis||Mean difference= GSK249320 5 mg/kg - Placebo Barthel Total Score= Treatment + Visit + Treatment \*Visit|Placebo Vs GSK249320 5 mg/kg, Visit 4||45.64|-3.66|
72586402|NCT00529373|144704544|OTHER||Mean Difference (Final Values)|-0.77||||0.896|TWO_SIDED|95.0|-12.34|10.79|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 48. Longitudinal model includes terms for treatment, stratum, region and interaction between treatment and time as fixed effects (LS Means weighted for region and stratum size).||10.79|-12.34|0.896
72413896|NCT00833989|144336880|SUPERIORITY_OR_OTHER||Mean Difference (Net)|11.79|STANDARD_ERROR_OF_MEAN|13.143|||TWO_SIDED|95.0|-14.9|38.5|||Mixed Model Repeated Measures Analysis||Mean difference= GSK249320 15 mg/kg - Placebo Barthel Total Score= Treatment + Visit + Treatment \*Visit|Placebo Vs GSK249320 15 mg/kg, Visit 4||38.50|-14.9|
72586403|NCT00529373|144704545|OTHER||Mean Difference (Final Values)|-29.43|||<|0.001|TWO_SIDED|95.0|-33.47|-25.39|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 6. Longitudinal model includes terms for treatment, stratum, region and interaction between treatment and time as fixed effects (LS Means weighted for region and stratum size).||-25.39|-33.47|<0.001
72413897|NCT00833989|144336880|SUPERIORITY_OR_OTHER||Mean Difference (Net)|15.71|STANDARD_ERROR_OF_MEAN|9.021|||TWO_SIDED|95.0|-2.63|34.06|||Mixed Model Repeated Measures Analysis||Mean difference= GSK249320 1 mg/kg - Placebo Barthel Total Score= Treatment + Visit + Treatment \*Visit|Placebo Vs GSK249320 1 mg/kg, Visit 6||34.06|-2.63|
72413898|NCT00833989|144336880|SUPERIORITY_OR_OTHER||Mean Difference (Net)|11.56|STANDARD_ERROR_OF_MEAN|8.835|||TWO_SIDED|95.0|-6.38|29.5|||Mixed Model Repeated Measures Analysis||Mean difference= GSK249320 5 mg/kg - Placebo Barthel Total Score= Treatment + Visit + Treatment \*Visit|Placebo Vs GSK249320 5 mg/kg, Visit 6||29.50|-6.38|
72413899|NCT00833989|144336880|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-7.49|STANDARD_ERROR_OF_MEAN|9.641|||TWO_SIDED|95.0|-27.1|12.08|||Mixed Model Repeated Measures Analysis||Mean difference= GSK249320 15 mg/kg - Placebo Barthel Total Score= Treatment + Visit + Treatment \*Visit|Placebo Vs GSK249320 15 mg/kg, Visit 6||12.08|-27.1|
72413900|NCT00833989|144336881|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.34|STANDARD_ERROR_OF_MEAN|1.849|||TWO_SIDED|95.0|-4.12|3.43|||ANCOVA||Mean difference= GSK249320 1 mg/kg - Placebo Day 90 MoCA = Treatment + Day 5 MoCA|Placebo Vs GSK249320 1 mg/kg, Visit 6||3.43|-4.12|
72413901|NCT00833989|144336881|SUPERIORITY_OR_OTHER||Median Difference (Net)|-0.17|STANDARD_ERROR_OF_MEAN|1.856|||TWO_SIDED|95.0|-3.96|3.62|||ANCOVA||Mean difference= GSK249320 5 mg/kg - Placebo Day 90 MoCA = Treatment + Day 5 MoCA|Placebo Vs GSK249320 5 mg/kg, Visit 6||3.62|-3.96|
72413902|NCT00833989|144336881|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.15|STANDARD_ERROR_OF_MEAN|2.037|||TWO_SIDED|95.0|-5.31|3.01|||ANCOVA||Mean difference= GSK249320 15 mg/kg - Placebo Day 90 MoCA = Treatment + Day 5 MoCA|Placebo Vs GSK249320 15 mg/kg, Visit 6||3.01|-5.31|
72413903|NCT00833989|144336882|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.24|STANDARD_ERROR_OF_MEAN|1.408|||TWO_SIDED|95.0|-3.12|2.63|||ANCOVA||"Mean difference= GSK249320 1 mg/kg - Placebo.~Day 90 GDS Score= Treatment + Day 5 GDS Score"|Placebo Vs GSK249320 1 mg/kg, Visit 6||2.63|-3.12|
72413904|NCT00833989|144336882|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.55|STANDARD_ERROR_OF_MEAN|1.347|||TWO_SIDED|95.0|-1.2|4.3|||ANCOVA||"Mean difference= GSK249320 5 mg/kg - Placebo~Day 90 GDS Score= Treatment + Day 5 GDS Score"|Placebo Vs GSK249320 5 mg/kg, Visit 6||4.30|-1.20|
72413905|NCT00833989|144336882|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.06|STANDARD_ERROR_OF_MEAN|1.486|||TWO_SIDED|95.0|-3.09|2.98|||ANCOVA||"Mean difference= GSK249320 15 mg/kg - Placebo.~Day 90 GDS Score= Treatment+Day 5 GDS Score"|Placebo Vs GSK249320 15 mg/kg, Visit 6||2.98|-3.09|
72413906|NCT00833989|144336883|SUPERIORITY_OR_OTHER||Median Difference (Net)|-0.289|STANDARD_ERROR_OF_MEAN|0.2639|||TWO_SIDED|95.0|-0.841|0.264|||Mixed Model Repeated Measures Analysis||Mean difference= GSK249320 1 mg/kg - Placebo Change from Baseline= Treatment + Visit + Treatment\* Visit + Baseline|Stimulation Level 100%, Visit 4 Day 30||0.264|-0.841|
72413907|NCT00833989|144336883|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.31|STANDARD_ERROR_OF_MEAN|0.2637|||TWO_SIDED|95.0|-0.862|0.241|||Mixed Model Repeated Measures Analysis||"Mean difference= GSK249320 5 mg/kg - Placebo~Change from Baseline= Treatment + Visit + Treatment\* Visit + Baseline"|Stimulation Level 100%, Visit 4 Day 30||0.241|-0.862|
72413908|NCT00833989|144336883|SUPERIORITY_OR_OTHER||Median Difference (Net)|-0.303|STANDARD_ERROR_OF_MEAN|0.3172|||TWO_SIDED|95.0|-0.966|0.361|||Mixed Model Repeated Measures Analysis||"Mean difference= GSK249320 15 mg/kg - Placebo~Change from Baseline= Treatment + Visit + Treatment\* Visit + Baseline"|Stimulation Level 100%, Visit 4 Day 30||0.361|-0.966|
72413909|NCT00833989|144336883|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.204|STANDARD_ERROR_OF_MEAN|0.1841|||TWO_SIDED|95.0|-0.184|0.593|||Mixed Model Repeated Measures Analysis||"Mean difference= GSK249320 1 mg/kg - Placebo~Change from Baseline= Treatment + Visit + Treatment\* Visit + Baseline"|Stimulation Level 100%, Visit 7 Day 112||0.593|-0.184|
72413910|NCT00833989|144336883|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.105|STANDARD_ERROR_OF_MEAN|0.1846|||TWO_SIDED|95.0|-0.284|0.494|||Mixed Model Repeated Measures Analysis||"Mean difference= GSK249320 5 mg/kg - Placebo~Change from Baseline= Treatment + Visit + Treatment\* Visit + Baseline"|Stimulation Level 100%, Visit 7 Day 112||0.494|-0.284|
72413911|NCT00833989|144336883|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.416|STANDARD_ERROR_OF_MEAN|0.2602|||TWO_SIDED|95.0|-0.132|0.965|||Mixed Model Repeated Measures Analysis||"Mean difference= GSK249320 15 mg/kg - Placebo~Change from Baseline= Treatment + Visit + Treatment\* Visit + Baseline"|Stimulation Level 100%, Visit 7 Day 112||0.965|-0.132|
72413912|NCT00833989|144336883|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.156|STANDARD_ERROR_OF_MEAN|0.8652|||TWO_SIDED|95.0|-0.65|2.961|||Mixed Model Repeated Measures Analysis||"Mean difference= GSK249320 1 mg/kg - Placebo~Change from Baseline= Treatment + Visit + Treatment\* Visit + Baseline"|Stimulation Level 110%, Visit 4 Day 30||2.961|-0.650|
72413913|NCT00833989|144336883|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.518|STANDARD_ERROR_OF_MEAN|0.8324|||TWO_SIDED|95.0|-2.249|1.213|||Mixed Model Repeated Measures Analysis||"Mean difference= GSK249320 5 mg/kg - Placebo~Change from Baseline= Treatment + Visit + Treatment\* Visit + Baseline"|Stimulation Level 110%, Visit 4 Day 30||1.213|-2.249|
72413914|NCT00833989|144336883|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.269|STANDARD_ERROR_OF_MEAN|1.0383|||TWO_SIDED|95.0|-2.436|1.898|||Mixed Model Repeated Measures Analysis||"Mean difference= GSK249320 15 mg/kg - Placebo~Change from Baseline= Treatment + Visit + Treatment\* Visit + Baseline"|Stimulation Level 110%, Visit 4 Day 30||1.898|-2.436|
72586404|NCT00529373|144704545|OTHER||Mean Difference (Final Values)|-25.94|||<|0.001|TWO_SIDED|95.0|-30.54|-21.34|||Longitudinal|||Odanacatib 50 mg OW - Placebo at Month 12. Longitudinal model includes terms for treatment, stratum, region and interaction between treatment and time as fixed effects (LS Means weighted for region and stratum size).||-21.34|-30.54|<0.001
72586405|NCT00529373|144704545|OTHER||Mean Difference (Final Values)|-16.26|||<|0.001|TWO_SIDED|95.0|-21.41|-11.12|||Longitudinal|||Odanacatib 50 mg OW - Placebo at Month 24. Longitudinal model includes terms for treatment, stratum, region and interaction between treatment and time as fixed effects (LS Means weighted for region and stratum size).||-11.12|-21.41|<0.001
72586406|NCT00529373|144704545|OTHER||Mean Difference (Final Values)|-12.11|||<|0.001|TWO_SIDED|95.0|-18.03|-6.19|||Longitudinal|||Odanacatib 50 mg OW - Placebo at Month 36. Longitudinal model includes terms for treatment, stratum, region and interaction between treatment and time as fixed effects (LS Means weighted for region and stratum size).||-6.19|-18.03|<0.001
72586407|NCT00529373|144704545|OTHER||Mean Difference (Final Values)|-3.34||||0.61|TWO_SIDED|95.0|-16.12|9.45|||Longitudinal|||Odanacatib 50 mg OW - Placebo at Month 48. Longitudinal model includes terms for treatment, stratum, region and interaction between treatment and time as fixed effects (LS Means weighted for region and stratum size).||9.45|-16.12|0.610
72586408|NCT00529373|144704546|OTHER||Hazard Ratio (HR)|1.12||||0.182|TWO_SIDED|95.0|0.95|1.34|||Regression, Cox|No adjustments for multiplicity were applied; p-value is unadjusted and therefore considered nominal.||Odanacatib 50 mg OW - Placebo||1.34|0.95|0.182
72586409|NCT00529373|144704547|OTHER||Hazard Ratio (HR)|1.18||||0.235|TWO_SIDED|95.0|0.9|1.55|||Regression, Cox|No adjustments for multiplicity were applied; all p-values reported were unadjusted and therefore considered nominal.||Odanacatib 50 mg OW - Placebo||1.55|0.9|0.235
72586410|NCT00529373|144704548|OTHER||Hazard Ratio (HR)|1.12||||0.127|TWO_SIDED|95.0|0.97|1.29|||Regression, Cox|No adjustments for multiplicity were applied; p-value is unadjusted and therefore considered nominal.||Odanacatib 50 mg OW - Placebo||1.29|0.97|0.127
72586411|NCT00529373|144704549|OTHER||Hazard Ratio (HR)|1.06||||0.857|TWO_SIDED|95.0|0.59|1.89|||Regression, Cox|No adjustments for multiplicity were applied; all p-values reported were unadjusted and therefore considered nominal.||Odanacatib 50 mg OW - Placebo||1.89|0.59|0.857
72586412|NCT00529373|144704550|OTHER||Hazard Ratio (HR)|1.1||||0.606|TWO_SIDED|95.0|0.76|1.59|||Regression, Cox|No adjustments for multiplicity were applied; all p-values reported were unadjusted and therefore considered nominal.||Odanacatib 50 mg OW - Placebo||1.59|0.76|0.606
72586413|NCT00529373|144704551|OTHER||Hazard Ratio (HR)|1.25||||0.074|TWO_SIDED|95.0|0.98|1.6|||Regression, Cox|No adjustments for multiplicity were applied; all p-values reported were unadjusted and therefore considered nominal.||Odanacatib 50 mg OW - Placebo||1.6|0.98|0.074
72586414|NCT00529373|144704552|OTHER||Hazard Ratio (HR)|1.12||||0.127|TWO_SIDED|95.0|0.97|1.29|||Regression, Cox|No adjustments for multiplicity were applied; all p-values reported were unadjusted and therefore considered nominal.||Odanacatib 50 mg OW - Placebo||1.29|0.97|0.127
72586415|NCT00529373|144704553|OTHER||Hazard Ratio (HR)|1.16||||0.277|TWO_SIDED|95.0|0.89|1.52|||Regression, Cox|No adjustments for multiplicity were applied; all p-values reported were unadjusted and therefore considered nominal.||Odanacatib 50 mg OW - Placebo||1.52|0.89|0.277
72413915|NCT00833989|144336883|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.806|STANDARD_ERROR_OF_MEAN|0.5862|||TWO_SIDED|95.0|-0.42|2.031|||Mixed Model Repeated Measures Analysis||"Mean difference= GSK249320 1 mg/kg - Placebo~Change from Baseline= Treatment + Visit + Treatment\* Visit + Baseline"|Stimulation Level 110%, Visit 7 Day 112||2.031|-0.420|
72586416|NCT00529373|144704554|OTHER||Hazard Ratio (HR)|0.82||||0.256|TWO_SIDED|95.0|0.58|1.15|||Regression, Cox|No adjustments for multiplicity were applied; all p-values reported were unadjusted and therefore considered nominal.||Odanacatib 50 mg OW - Placebo||1.15|0.58|0.256
72586417|NCT00529373|144704555|OTHER||Hazard Ratio (HR)|0.86||||0.794|TWO_SIDED|95.0|0.29|2.57|||Regression, Cox|No adjustments for multiplicity were applied; all p-values reported were unadjusted and therefore considered nominal.||Odanacatib 50 mg OW - Placebo||2.57|0.29|0.794
72586418|NCT00529373|144704556|OTHER||Hazard Ratio (HR)|1.32||||0.034|TWO_SIDED|95.0|1.02|1.7|||Regression, Cox|No adjustments for multiplicity were applied; all p-values reported were unadjusted and therefore considered nominal.||Odanacatib 50 mg OW - Placebo||1.7|1.02|0.034
72586419|NCT00529373|144704557|OTHER||Hazard Ratio (HR)|1.91||||0.081|TWO_SIDED|95.0|0.93|3.97|||Regression, Cox|No adjustments for multiplicity were applied; all p-values reported were unadjusted and therefore considered nominal.||Odanacatib 50 mg OW - Placebo||3.97|0.93|0.081
72586420|NCT00529373|144704558|OTHER||Difference in Least Squares Means|1.47|||<|0.001|TWO_SIDED|95.0|0.92|2.01|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 6. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||2.01|0.92|<0.001
72586421|NCT00529373|144704558|OTHER||Difference in Least Squares Means|2.21|||<|0.001|TWO_SIDED|95.0|2.05|2.37|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 12. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||2.37|2.05|<0.001
72586422|NCT00529373|144704558|OTHER||Difference in Least Squares Means|4.39|||<|0.001|TWO_SIDED|95.0|4.2|4.57|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 24. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||4.57|4.20|<0.001
72586423|NCT00529373|144704558|OTHER||Difference in Least Squares Means|6.5|||<|0.001|TWO_SIDED|95.0|6.28|6.72|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 36. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||6.72|6.28|<0.001
72586424|NCT00529373|144704558|OTHER||Difference in Least Squares Means|8.29|||<|0.001|TWO_SIDED|95.0|8.02|8.57|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 48. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||8.57|8.02|<0.001
72586425|NCT00529373|144704558|OTHER||Difference in Least Squares Means|10.05|||<|0.001|TWO_SIDED|95.0|9.72|10.38|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 60. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||10.38|9.72|<0.001
72413916|NCT00833989|144336883|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.007|STANDARD_ERROR_OF_MEAN|0.564|||TWO_SIDED|95.0|-1.183|1.168|||Mixed Model Repeated Measures Analysis||"Mean difference= GSK249320 5 mg/kg - Placebo~Change from Baseline= Treatment + Visit + Treatment\* Visit"|Stimulation Level 110%, Visit 7 Day 112||1.168|-1.183|
72413917|NCT00833989|144336883|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.506|STANDARD_ERROR_OF_MEAN|0.757|||TWO_SIDED|95.0|-0.064|3.077|||Mixed Model Repeated Measures Analysis||"Mean difference= GSK249320 15 mg/kg - Placebo~Change from Baseline= Treatment + Visit + Treatment\* Visit + Baseline"|Stimulation Level 110%, Visit 7 Day 112||3.077|-0.064|
72586426|NCT00529373|144704559|OTHER||Difference in Least Squares Means|1.1|||<|0.001|TWO_SIDED|95.0|0.66|1.54|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 12. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||1.54|0.66|<0.001
72586427|NCT00529373|144704559|OTHER||Difference in Least Squares Means|1.36|||<|0.001|TWO_SIDED|95.0|0.87|1.85|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 24. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||1.85|0.87|<0.001
72586428|NCT00529373|144704559|OTHER||Difference in Least Squares Means|1.96|||<|0.001|TWO_SIDED|95.0|1.42|2.5|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 36. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||2.50|1.42|<0.001
72586429|NCT00529373|144704559|OTHER||Difference in Least Squares Means|2.18|||<|0.001|TWO_SIDED|95.0|1.4|2.96|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 48. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||2.96|1.40|<0.001
72586430|NCT00529373|144704559|OTHER||Difference in Least Squares Means|2.33||||0.001|TWO_SIDED|95.0|1.54|3.11|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 60. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||3.11|1.54|0.001
72586431|NCT00529373|144704560|OTHER||Hazard Ratio (HR)|0.33|||<|0.001|TWO_SIDED|95.0|0.24|0.45|||Regression, Cox|||Odanacatib 50 mg OW vs Placebo. the Cox proportional hazards model included terms for treatment, stratum and geographic region.||0.45|0.24|<0.001
72413918|NCT00833989|144336883|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.644|STANDARD_ERROR_OF_MEAN|1.2976|||TWO_SIDED|95.0|-1.056|4.344|||Mixed Model Repeated Measures Analysis||"Mean difference= GSK249320 1 mg/kg - Placebo~Change from Baseline= Treatment + Visit + Treatment\* Visit + Baseline"|Stimulation Level 120%, Visit 4 Day 30||4.344|-1.056|
72586432|NCT00529373|144704561|OTHER||Hazard Ratio (HR)|0.67|||<|0.001|TWO_SIDED|95.0|0.6|0.75|||Regression, Cox|||Odanacatib 50 mg OW vs Placebo. The Cox proportional hazards model included terms for treatment, stratum and geographic region.||0.75|0.60|<0.001
72586433|NCT00529373|144704562|OTHER||Difference in Least Squares Means|1.34|||<|0.001|TWO_SIDED|95.0|0.94|1.74|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 6. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||1.74|0.94|<0.001
72586434|NCT00529373|144704562|OTHER||Difference in Least Squares Means|2.5|||<|0.001|TWO_SIDED|95.0|2.38|2.62|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 12. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||2.62|2.38|<0.001
72586435|NCT00529373|144704562|OTHER||Difference in Least Squares Means|4.47|||<|0.001|TWO_SIDED|95.0|4.31|4.62|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 24. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||4.62|4.31|<0.001
72586436|NCT00529373|144704562|OTHER||Difference in Least Squares Means|6.46|||<|0.001|TWO_SIDED|95.0|6.26|6.65|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 36. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||6.65|6.26|<0.001
72586437|NCT00529373|144704562|OTHER||Difference in Least Squares Means|8.48|||<|0.001|TWO_SIDED|95.0|8.24|8.73|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 48. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||8.73|8.24|<0.001
72586438|NCT00529373|144704562|OTHER||Difference in Least Squares Means|10.29|||<|0.001|TWO_SIDED|95.0|9.99|10.59|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 60. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||10.59|9.99|<0.001
72586439|NCT00529373|144704563|OTHER||Difference in Least Squares Means|1.74|||<|0.001|TWO_SIDED|95.0|1.06|2.42|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 6. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||2.42|1.06|<0.001
72586440|NCT00529373|144704563|OTHER||Difference in Least Squares Means|3.5|||<|0.001|TWO_SIDED|95.0|3.31|3.7|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 12. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||3.70|3.31|<0.001
72586441|NCT00529373|144704563|OTHER||Difference in Least Squares Means|6.41|||<|0.001|TWO_SIDED|95.0|6.16|6.65|||Longitudinal model|Includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size)||Odanacatib 50 mg OW - Placebo at Month 24||6.65|6.16|<0.001
72586442|NCT00529373|144704563|OTHER||Difference in Least Squares Means|9.25|||<|0.001|TWO_SIDED|95.0|8.95|9.54|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 36. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||9.54|8.95|<0.001
72586443|NCT00529373|144704563|OTHER||Difference in Least Squares Means|12.14|||<|0.001|TWO_SIDED|95.0|11.76|12.51|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 48. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||12.51|11.76|<0.001
72413919|NCT00833989|144336883|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.231|STANDARD_ERROR_OF_MEAN|1.1762|||TWO_SIDED|95.0|-2.681|2.219|||Mixed Model Repeated Measures Analysis||"Mean difference= GSK249320 5 mg/kg - Placebo~Change from Baseline= Treatment + Visit + Treatment\* Visit + Baseline"|Stimulation Level 120%, Visit 4 Day 30||2.219|-2.681|
72413920|NCT00833989|144336883|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.184|STANDARD_ERROR_OF_MEAN|1.4796|||TWO_SIDED|95.0|-3.279|2.91|||Mixed Model Repeated Measures Analysis||"Mean difference= GSK249320 15 mg/kg - Placebo~Change from Baseline= Treatment + Visit + Treatment\* Visit + Baseline"|Stimulation Level 120%, Visit 4 Day 30||2.910|-3.279|
72586444|NCT00529373|144704563|OTHER||Difference in Least Squares Means|14.56|||<|0.001|TWO_SIDED|95.0|14.11|15.01|||Longitudinal model|Includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size)||Odanacatib 50 mg OW - Placebo at Month 60. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||15.01|14.11|<0.001
72586445|NCT00529373|144704564|OTHER||Difference in Least Squares Means|2.9|||<|0.001|TWO_SIDED|95.0|2.4|3.39|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 6. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||3.39|2.40|<0.001
72586446|NCT00529373|144704564|OTHER||Difference in Least Squares Means|4.01|||<|0.001|TWO_SIDED|95.0|3.87|4.15|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 12. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||4.15|3.87|<0.001
72586447|NCT00529373|144704564|OTHER||Difference in Least Squares Means|5.93|||<|0.001|TWO_SIDED|95.0|5.75|6.11|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 24. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||6.11|5.75|<0.001
72413921|NCT00833989|144336883|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.622|STANDARD_ERROR_OF_MEAN|0.9746|||TWO_SIDED|95.0|-1.428|2.672|||Mixed Model Repeated Measures Analysis||"Mean difference= GSK249320 1 mg/kg - Placebo~Change from Baseline= Treatment + Visit + Treatment\* Visit + Baseline"|Stimulation Level 120%, Visit 7 Day 112||2.672|-1.428|
72413922|NCT00833989|144336883|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.602|STANDARD_ERROR_OF_MEAN|0.934|||TWO_SIDED|95.0|-2.56|1.356|||Mixed Model Repeated Measures Analysis||"Mean difference= GSK249320 5 mg/kg - Placebo~Change from Baseline= Treatment + Visit + Treatment\* Visit + Baseline"|Stimulation Level 120%, Visit 7 Day 112||1.356|-2.560|
72413923|NCT00833989|144336883|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.063|STANDARD_ERROR_OF_MEAN|1.281|||TWO_SIDED|95.0|-0.61|4.736|||Mixed Model Repeated Measures Analysis||"Mean difference= GSK249320 15 mg/kg - Placebo~Change from Baseline= Treatment + Visit + Treatment\* Visit + Baseline"|Stimulation Level 120%, Visit 7 Day 112||4.736|-0.610|
72586448|NCT00529373|144704564|OTHER||Difference in Least Squares Means|7.7|||<|0.001|TWO_SIDED|95.0|7.48|7.91|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 36. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||7.91|7.48|<0.001
72413924|NCT00833989|144336883|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.556|STANDARD_ERROR_OF_MEAN|1.4588|||TWO_SIDED|95.0|-1.494|4.607|||Mixed Model Repeated Measures Analysis||"Mean difference= GSK249320 1 mg/kg - Placebo~Change from Baseline= Treatment + Visit + Treatment\* Visit + Baseline"|Stimulation Level 130%, Visit 4 Day 30||4.607|-1.494|
72413925|NCT00833989|144336883|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.531|STANDARD_ERROR_OF_MEAN|1.2336|||TWO_SIDED|95.0|-3.102|2.041|||Mixed Model Repeated Measures Analysis||"Mean difference= GSK249320 5 mg/kg - Placebo~Change from Baseline= Treatment + Visit + Treatment\* Visit + Baseline"|Stimulation Level 130%, Visit 4 Day 30||2.041|-3.102|
72413926|NCT00833989|144336883|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.185|STANDARD_ERROR_OF_MEAN|1.5697|||TWO_SIDED|95.0|-3.471|3.101|||Mixed Model Repeated Measures Analysis||"Mean difference= GSK249320 15 mg/kg - Placebo~Change from Baseline= Treatment + Visit + Treatment\* Visit + Baseline"|Stimulation Level 130%, Visit 4 Day 30||3.101|-3.471|
72586449|NCT00529373|144704564|OTHER||Difference in Least Squares Means|9.34|||<|0.001|TWO_SIDED|95.0|9.08|9.61|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 48. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||9.61|9.08|<0.001
72586450|NCT00529373|144704564|OTHER||Difference in Least Squares Means|10.87|||<|0.001|TWO_SIDED|95.0|10.55|11.19|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 48. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||11.19|10.55|<0.001
72586451|NCT00529373|144704573|OTHER||Difference in Least Squares Means|2.76|||<|0.001|TWO_SIDED|95.0|1.43|4.1|||Longitudinal model|||Odanacatib 50 mg OW - Placebo||4.10|1.43|<0.001
72586452|NCT00529373|144704574|OTHER||Difference in Least Squares Means|5.55|||<|0.001|TWO_SIDED|95.0|4.06|7.05|||Longitudinal model|||Odanacatib 50 mg OW - Placebo||7.05|4.06|<0.001
72586453|NCT00529373|144704575|OTHER||Difference in Least Squares Means|2.79||||0.005|TWO_SIDED|95.0|0.86|4.72|||Longitudinal model|||Odanacatib 50 mg OW - Placebo||4.72|0.86|0.005
72586454|NCT00529373|144704576|OTHER||Difference in Least Squares Means|3.63|||<|0.001|TWO_SIDED|95.0|2.35|4.9|||Longitudinal model|||Odanacatib 50 mg OW - Placebo||4.90|2.35|<0.001
72586455|NCT00529373|144704577|OTHER||Difference in Least Squares Means|5.65|||<|0.001|TWO_SIDED|95.0|3.79|7.5|||Longitudinal model|||Odanacatib 50 mg OW - Placebo||7.50|3.79|<0.001
72586456|NCT00529373|144704578|OTHER||Difference in Least Squares Means|-62.25|||<|0.001|TWO_SIDED|95.0|-79.99|-44.5|||Longitudinal model|||Odanacatib 50 mg OW - Placebo||-44.50|-79.99|<0.001
72586457|NCT00529373|144704579|OTHER||Difference in Least Squares Means|-26.7||||0.001|TWO_SIDED|95.0|-42.56|-10.83|||Longitudinal model|||Odanacatib 50 mg OW - Placebo||-10.83|-42.56|0.001
72586458|NCT00529373|144704580|OTHER||Difference in Least Squares Means|1.67||||0.016|TWO_SIDED|95.0|0.32|3.01|||Longitudinal model|||Odanacatib 50 mg OW - Placebo||3.01|0.32|0.016
72586459|NCT00529373|144704581|OTHER||Difference in Least Squares Means|-25.02|||<|0.001|TWO_SIDED|95.0|-35.92|-14.12|||Longitudinal model|||Odanacatib 50 mg OW - Placebo||-14.12|-35.92|<0.001
72586460|NCT00529373|144704582|OTHER||Difference in Least Squares Means|-64.43|||<|0.001|TWO_SIDED|95.0|-87.8|-41.07|||Longitudinal model|||Odanacatib 50 mg OW - Placebo||-41.07|-87.80|<0.001
72586461|NCT00529373|144704583|OTHER||Difference in Least Squares Means|8.53|||<|0.001|TWO_SIDED|95.0|5.79|11.28|||Longitudinal model|||Odanacatib 50 mg OW - Placebo||11.28|5.79|<0.001
72586462|NCT00529373|144704584|OTHER||Difference in Least Squares Means|11.08|||<|0.001|TWO_SIDED|95.0|8.41|13.74|||Longitudinal model|||Odanacatib 50 mg OW - Placebo||13.74|8.41|<0.001
72586463|NCT00529373|144704585|OTHER||Difference in Least Squares Means|10.41|||<|0.001|TWO_SIDED|95.0|8.05|12.78|||Longitudinal model|||Odanacatib 50 mg OW - Placebo||12.78|8.05|<0.001
72586464|NCT00529373|144704586|OTHER||Difference in Least Squares Means|9.98|||<|0.001|TWO_SIDED|95.0|6.91|13.06|||Longitudinal model|||Odanacatib 50 mg OW - Placebo||13.06|6.91|<0.001
72586465|NCT00529373|144704587|OTHER||Difference in Least Squares Means|14.94|||<|0.001|TWO_SIDED|95.0|11.29|18.59|||Longitudinal model|||Odanacatib 50 mg OW - Placebo||18.59|11.29|<0.001
72586466|NCT00529373|144704588|OTHER||Hazard Ratio (HR)|0.79||||0.366|TWO_SIDED|95.0|0.47|1.33|||Regression, Cox|No adjustments for multiplicity were applied; all p-values reported were unadjusted and therefore considered nominal.||Odanacatib 50 mg OW - Placebo||1.33|0.47|0.366
72586467|NCT00529373|144704589|OTHER||Hazard Ratio (HR)|1.13||||0.246|TWO_SIDED|95.0|0.92|1.4|||Regression, Cox|No adjustments for multiplicity were applied; all p-values reported were unadjusted and therefore considered nominal.||Odanacatib 50 mg OW - Placebo||1.4|0.92|0.246
72586468|NCT00529373|144704590|OTHER||Hazard Ratio (HR)|0.8||||0.638|TWO_SIDED|95.0|0.32|2.03|||Regression, Cox|No adjustments for multiplicity were applied; all p-values reported were unadjusted and therefore considered nominal.||Odanacatib 50 mg OW - Placebo||2.03|0.32|0.638
72586469|NCT00529373|144704591|OTHER||Hazard Ratio (HR)|1.17||||0.029|TWO_SIDED|95.0|1.02|1.36|||Regression, Cox|No adjustments for multiplicity were applied; p-value is unadjusted and therefore considered nominal.||Odanacatib 50 mg OW - Placebo||1.36|1.02|0.029
72586470|NCT00529373|144704592|OTHER||Hazard Ratio (HR)|1.05||||0.341|TWO_SIDED|95.0|0.95|1.17|||Regression, Cox|No adjustments for multiplicity were applied; all p-values reported were unadjusted and therefore considered nominal.||Odanacatib 50 mg OW - Placebo||1.17|0.95|0.341
72586471|NCT00529373|144704593|OTHER||Hazard Ratio (HR)|1.23||||0.198|TWO_SIDED|95.0|0.9|1.68|||Regression, Cox|No adjustments for multiplicity were applied; all p-values reported were unadjusted and therefore considered nominal.||Odanacatib 50 mg OW - Placebo||1.68|0.9|0.198
72586472|NCT00529373|144704594|OTHER||Hazard Ratio (HR)|0.94||||0.798|TWO_SIDED|95.0|0.7|1.26|||Regression, Cox|No adjustments for multiplicity were applied; all p-values reported were unadjusted and therefore considered nominal.||Odanacatib 50 mg OW - Placebo||1.26|0.7|0.798
72586473|NCT00529373|144704595|OTHER||Hazard Ratio (HR)|1.37||||0.005|TWO_SIDED|95.0|1.1|1.71|||Regression, Cox|No adjustments for multiplicity were applied; all p-values reported were unadjusted and therefore considered nominal.||Odanacatib 50 mg OW - Placebo||1.71|1.1|0.005
72586474|NCT00529373|144704596|OTHER||Hazard Ratio (HR)|1.22||||0.059|TWO_SIDED|95.0|0.99|1.5|||Regression, Cox|No adjustments for multiplicity were applied; all p-values reported were unadjusted and therefore considered nominal.||Odanacatib 50 mg OW - Placebo||1.5|0.99|0.059
72586475|NCT00529373|144704597|OTHER||Hazard Ratio (HR)|1.61||||0.114|TWO_SIDED|95.0|0.89|2.9|||Regression, Cox|No adjustments for multiplicity were applied; all p-values reported were unadjusted and therefore considered nominal.||Odanacatib 50 mg OW - Placebo||2.9|0.89|0.114
72586476|NCT00529373|144704598|OTHER||Hazard Ratio (HR)|1.14||||0.159|TWO_SIDED|95.0|0.99|1.31|||Regression, Cox|No adjustments for multiplicity were applied; p-value is unadjusted and therefore considered nominal.||Odanacatib 50 mg OW - Placebo||1.31|0.99|0.159
72586477|NCT00529373|144704599|OTHER||Hazard Ratio (HR)|1.17||||0.178|TWO_SIDED|95.0|0.93|1.46|||Regression, Cox|No adjustments for multiplicity were applied; all p-values reported were unadjusted and therefore considered nominal.||Odanacatib 50 mg OW - Placebo||1.46|0.93|0.178
72586478|NCT00529373|144704600|OTHER|Miettinen \& Nurminen|Difference in rates|0.04|||||TWO_SIDED|95.0|-0.01|0.09||||||||0.09|-0.01|
72586479|NCT00529373|144704601|OTHER|Miettinen \& Nurminen|Difference in rates|0.02|||||TWO_SIDED|95.0|0.01|0.05||||||||0.05|0.01|
72586480|NCT00529373|144704602|OTHER|Miettinen \& Nurminen|Difference in rates|0.06|||||TWO_SIDED|95.0|0.03|0.11||||||||0.11|0.03|
72586481|NCT00529373|144704603|OTHER|Miettinen \& Nurminen|Difference in rates|0.03|||||TWO_SIDED|95.0|0.02|0.06||||||||0.06|0.02|
72586482|NCT03627546|144704626|SUPERIORITY|||||||0.01|||||||Chi-squared|||||||.01
72586483|NCT03627546|144704627|SUPERIORITY|||||||0.0007|||||||Chi-squared|||||||0.0007
72586484|NCT00615550|144704631|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.55||||0.02|TWO_SIDED|95.0|0.33|0.92|||Cochran-Mantel-Haenszel|||||0.92|0.33|0.020
72586485|NCT00615550|144704632|SUPERIORITY_OR_OTHER|||||||0.048||95.0|||||Cochran-Mantel-Haenszel|||Statistical analysis presented for composite score data.||||0.048
72586486|NCT00615550|144704632|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.39||||0.026|TWO_SIDED|95.0|0.17|0.92|||Cochran-Mantel-Haenszel|||Statistical analysis presented for RDS data.||0.92|0.17|0.026
72586487|NCT00615550|144704633|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.5||||0.036|TWO_SIDED|95.0|0.25|0.97|||Cochran-Mantel-Haenszel|||Statistical analysis presented for births \<=27 6/7 weeks data.||0.97|0.25|0.036
72586488|NCT00615550|144704633|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.62||||0.016|TWO_SIDED|95.0|0.42|0.92|||Cochran-Mantel-Haenszel|||Statistical analysis presented for \<= 34 6/7 weeks data.||0.92|0.42|0.016
72586489|NCT00615550|144704633|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.89||||0.376|TWO_SIDED|95.0|0.68|1.16|||Cochran-Mantel-Haenszel|||Statistical analysis presented for \<36 weeks data.||1.16|0.68|0.376
72586490|NCT00615550|144704634|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.57||||0.431|TWO_SIDED|95.0|0.14|2.35|||Cochran-Mantel-Haenszel|||||2.35|0.14|0.431
72586491|NCT00615550|144704635|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.47||||0.01|TWO_SIDED|95.0|0.26|0.85|||Cochran-Mantel-Haenszel|||Statistical analysis for birth weight \< 1500 grams data.||0.85|0.26|0.01
72586492|NCT00615550|144704635|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.83||||0.213|TWO_SIDED|95.0|0.62|1.11|||Cochran-Mantel-Haenszel|||Statistical analysis for birth weight \< 2500 grams data.||1.11|0.62|0.213
72586493|NCT02640664|144704651|SUPERIORITY||Mean Difference (Net)|4.7|STANDARD_ERROR_OF_MEAN|2.93|||TWO_SIDED|95.0|-1.1|10.5||primary endpoint in the extension study does not have p-values. It's a descriptive analysis.|ANOVA|||||10.5|-1.1|
72586494|NCT02640664|144704651|SUPERIORITY||Mean Difference (Net)|2.5|STANDARD_ERROR_OF_MEAN|2.96|||TWO_SIDED|95.0|-3.4|8.3||primary endpoint in the extension study does not have p-values. It's a descriptive analysis.|ANOVA|||||8.3|-3.4|
72586495|NCT02640664|144704651|SUPERIORITY||Mean Difference (Net)|2.2|STANDARD_ERROR_OF_MEAN|2.79|||TWO_SIDED|95.0|-3.3|7.8||primary endpoint in the extension study does not have p-values. It's a descriptive analysis.|ANOVA|||||7.8|-3.3|
72586496|NCT02640664|144704654|SUPERIORITY||Mean Difference (Net)|8.0|STANDARD_ERROR_OF_MEAN|4.42|||TWO_SIDED|95.0|-0.8|16.7||P value not applicable because it's a descriptive analysis.|ANOVA|||||16.7|-0.8|
72586497|NCT02640664|144704654|SUPERIORITY||Mean Difference (Net)|1.6|STANDARD_ERROR_OF_MEAN|4.49|||TWO_SIDED|95.0|-7.3|10.5||P value not applicable because it's a descriptive analysis.|ANOVA|||||10.5|-7.3|
72586498|NCT02640664|144704654|SUPERIORITY||Mean Difference (Net)|6.4|STANDARD_ERROR_OF_MEAN|4.24|||TWO_SIDED|95.0|-2.0|14.8|||ANOVA|||||14.8|-2.0|
72586499|NCT01329380|144704677|OTHER|||||||0.0328|||||||Mann-Whitney U-test|||Age||||0.0328
72586500|NCT01329380|144704677|OTHER|||||||0.7128|||||||Fisher Exact|||Sex||||0.7128
72586501|NCT01329380|144704677|OTHER|||||||0.0465|||||||Mann-Whitney U-test|||Body mass index||||0.0465
72586502|NCT01329380|144704677|OTHER|||||||0.8872|||||||Mann-Whitney U-test|||Duration of illness||||0.8872
72586503|NCT01329380|144704677|OTHER|||||||0.0388|||||||Fisher Exact|||Smoking history||||0.0388
72586504|NCT01329380|144704677|OTHER|||||||0.4855|||||||Fisher Exact|||Complications||||0.4855
72586505|NCT01329380|144704677|OTHER|||||||0.663|||||||Fisher Exact|||Complications - Liver disorder||||0.6630
72586506|NCT01329380|144704677|OTHER|||||||0.2067|||||||Fisher Exact|||Complications - Renal disorder||||0.2067
72586507|NCT01329380|144704677|OTHER|||||||0.8749|||||||Fisher Exact|||Complications - Cardiovascular disorder||||0.8749
72586508|NCT01329380|144704677|OTHER|||||||0.482|||||||Fisher Exact|||Complications - Blood disorder||||0.4820
72586509|NCT01329380|144704677|OTHER|||||||0.6355|||||||Fisher Exact|||Complications - Respiratory disorder||||0.6355
72586510|NCT01329380|144704677|OTHER|||||||0.8193|||||||Fisher Exact|||Complications - Diabetes mellitus||||0.8193
72586511|NCT01329380|144704677|OTHER|||||||0.5723|||||||Fisher Exact|||Complications - Uveitis||||0.5723
72413927|NCT00833989|144336883|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.686|STANDARD_ERROR_OF_MEAN|1.2689|||TWO_SIDED|95.0|-1.996|3.367|||Mixed Model Repeated Measures Analysis||"Mean difference= GSK249320 1 mg/kg - Placebo~Change from Baseline= Treatment + Visit + Treatment\* Visit + Baseline"|Stimulation Level 130%, Visit 7 Day 112||3.367|-1.996|
72586512|NCT01329380|144704677|OTHER|||||||1|||||||Fisher Exact|||Complications - Inflammatory bowel disease||||1.0000
72586513|NCT01329380|144704677|OTHER|||||||1|||||||Fisher Exact|||Complications - Psoriasis||||1.0000
72586514|NCT01329380|144704677|OTHER|||||||0.0144|||||||Fisher Exact|||Past Illnesses||||0.0144
72586515|NCT01329380|144704677|OTHER|||||||1|||||||Fisher Exact|||Allergy history||||1.0000
72586516|NCT01329380|144704677|OTHER|||||||0.3928|||||||Fisher Exact|||Adalimumab self-injection status||||0.3928
72586517|NCT01329380|144704677|OTHER|||||||0.2735|||||||Fisher Exact|||Prior medications - NSAIDs||||0.2735
72586518|NCT01329380|144704677|OTHER|||||||0.8875|||||||Fisher Exact|||Prior medications - Biological products||||0.8875
72586519|NCT01329380|144704677|OTHER|||||||0.254|||||||Fisher Exact|||Prior medications - Adrenal corticosteroids||||0.2540
72413928|NCT00833989|144336883|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.556|STANDARD_ERROR_OF_MEAN|1.0822|||TWO_SIDED|95.0|-2.838|1.726|||Mixed Model Repeated Measures Analysis||"Mean difference= GSK249320 5 mg/kg - Placebo~Change from Baseline= Treatment + Visit + Treatment\* Visit + Baseline"|Stimulation Level 130%, Visit 7 Day 112||1.726|-2.838|
72413929|NCT00833989|144336883|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.219|STANDARD_ERROR_OF_MEAN|1.4792|||TWO_SIDED|95.0|-0.884|5.322|||Mixed Model Repeated Measures Analysis||"Mean difference= GSK249320 15 mg/kg - Placebo~Change from Baseline= Treatment + Visit + Treatment\* Visit + Baseline"|Stimulation Level 130%, Visit 7 Day 112||5.322|-0.884|
72413930|NCT00833989|144336883|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.631|STANDARD_ERROR_OF_MEAN|1.589|||TWO_SIDED|95.0|-1.696|4.958|||Mixed Model Repeated Measures Analysis||"Mean difference= GSK249320 1 mg/kg - Placebo~Change from Baseline= Treatment + Visit + Treatment\* Visit + Baseline"|Stimulation Level 140%, Visit 4 Day 30||4.958|-1.696|
72413931|NCT00833989|144336883|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.508|STANDARD_ERROR_OF_MEAN|1.2985|||TWO_SIDED|95.0|-3.219|2.203|||Mixed Model Repeated Measures Analysis||"Mean difference= GSK249320 5 mg/kg - Placebo~Change from Baseline= Treatment + Visit + Treatment\* Visit + Baseline"|Stimulation Level 140%, Visit 4 Day 30||2.203|-3.219|
72413932|NCT00833989|144336883|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.11|STANDARD_ERROR_OF_MEAN|1.6603|||TWO_SIDED|95.0|-3.369|3.588|||Mixed Model Repeated Measures Analysis||"Mean difference= GSK249320 15 mg/kg - Placebo~Change from Baseline= Treatment + Visit + Treatment\* Visit + Baseline"|Stimulation Level 140%, Visit 4 Day 30||3.588|-3.369|
72413933|NCT00833989|144336883|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.852|STANDARD_ERROR_OF_MEAN|1.5675|||TWO_SIDED|95.0|-2.446|4.15|||Mixed Model Repeated Measures Analysis||"Mean difference= GSK249320 1 mg/kg - Placebo~Change from Baseline= Treatment + Visit + Treatment\* Visit + Baseline"|Stimulation Level 140%, Visit 7 Day 112||4.150|-2.446|
72413934|NCT00833989|144336883|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.357|STANDARD_ERROR_OF_MEAN|1.2918|||TWO_SIDED|95.0|-3.074|2.359|||Mixed Model Repeated Measures Analysis||"Mean difference= GSK249320 5 mg/kg - Placebo~Change from Baseline= Treatment + Visit + Treatment\* Visit + Baseline"|Stimulation Level 140%, Visit 7 Day 112||2.359|-3.074|
72586520|NCT01329380|144704677|OTHER|||||||0.0226|||||||Fisher Exact|||Concomitant drugs||||0.0226
72413935|NCT00833989|144336883|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.686|STANDARD_ERROR_OF_MEAN|1.7306|||TWO_SIDED|95.0|-1.937|5.308|||Mixed Model Repeated Measures Analysis||"Mean difference= GSK249320 15 mg/kg - Placebo~Change from Baseline= Treatment + Visit + Treatment\* Visit + Baseline"|Stimulation Level 140%, Visit 7 Day 112||5.308|-1.937|
72413936|NCT01949480|144336885|NON_INFERIORITY|To detect an effect size of 0.92 SD units with a power of 81% and alpha level of 0.05, a total sample size of 40 patients (20 patients/group) was calculated.||||||0.643|||||||t-test, 2 sided|||||||0.643
72586521|NCT01329380|144704677|OTHER|||||||1|||||||Fisher Exact|||Concomitant drug: NSAIDs||||1.0000
72413937|NCT01949480|144336887|NON_INFERIORITY|To detect an effect size of 0.92 SD units with a power of 81% and alpha level of 0.05, a total sample size of 40 patients (20 patients/group) was calculated.||||||0.077|||||||t-test, 2 sided|||This p-value is calculated for the NRS at rest.||||.077
72413938|NCT01949480|144336887|NON_INFERIORITY|To detect an effect size of 0.92 SD units with a power of 81% and alpha level of 0.05, a total sample size of 40 patients (20 patients/group) was calculated.||||||0.39|||||||t-test, 2 sided|||This p-value is calculated for the NRS during deep inspiration at 24 hrs.||||0.39
72413939|NCT01949480|144336888|NON_INFERIORITY|To detect an effect size of 0.92 SD units with a power of 81% and alpha level of 0.05, a total sample size of 40 patients (20 patients/group) was calculated.||||||0.605|||||||t-test, 2 sided|||||||0.605
72413940|NCT01949480|144336889|NON_INFERIORITY|To detect an effect size of 0.92 SD units with a power of 81% and alpha level of 0.05, a total sample size of 40 patients (20 patients/group) was calculated.||||||0.104|||||||t-test, 2 sided|||This p-value is for the Local Anesthetic infused in 24 hrs.||||0.104
72413941|NCT01949480|144336890|NON_INFERIORITY|To detect an effect size of 0.92 SD units with a power of 81% and alpha level of 0.05, a total sample size of 40 patients (20 patients/group) was calculated.||||||0.308|||||||t-test, 2 sided|||||||0.308
72413942|NCT01949480|144336891|NON_INFERIORITY|To detect an effect size of 0.92 SD units with a power of 81% and alpha level of 0.05, a total sample size of 40 patients (20 patients/group) was calculated.||||||0.487|||||||t-test, 2 sided|||||||0.487
72413943|NCT01949480|144336892|NON_INFERIORITY|To detect an effect size of 0.92 SD units with a power of 81% and alpha level of 0.05, a total sample size of 40 patients (20 patients/group) was calculated.||||||0.493|||||||t-test, 2 sided|||||||0.493
72586522|NCT01329380|144704677|OTHER|||||||0.2481|||||||Fisher Exact|||Concomitant drugs - DMARDs||||0.2481
72586523|NCT01329380|144704677|OTHER|||||||0.1558|||||||Fisher Exact|||Concomitant drugs - Methotrexate||||0.1558
72586524|NCT01329380|144704677|OTHER|||||||1|||||||Fisher Exact|||Concomitant drugs - salazosulfapyridine||||1.0000
72586525|NCT01329380|144704677|OTHER|||||||0.0094|||||||Fisher Exact|||Concomitant drugs - Adrenal corticosteroids||||0.0094
72586526|NCT01329380|144704677|OTHER|||||||1|||||||Fisher Exact|||Concomitant therapy||||1.0000
72586527|NCT01329380|144704677|OTHER|||||||0.8836|||||||Fisher Exact|||Human leukocyte antigen B27 (HLA-B27) test result||||0.8836
72586528|NCT01329380|144704677|OTHER|||||||1|||||||Fisher Exact|||BASDAI at start of treatment||||1.0000
72586529|NCT01294241|144704684|SUPERIORITY_OR_OTHER||||||=|0.008||||||Post-hoc superiority analysis: Wounds that were either evaluated controversially (n=2) or as being equal (n=2) were excluded from the analysis of the primary efficacy variable.|Two-sided exact binomial test|||The intra-individual difference in reepithelialization of wound (halves) was tested using a two-sided exact binomial test. The test was performed at a significance level of 5% for the null-hypothesis of no difference δ = 0 against the hypotheses δ ≠ 0: H0: δ = 0 H1: δ ≠ 0||||=0.008
72586530|NCT01294241|144704685|SUPERIORITY_OR_OTHER||||||=|0.21||||||Post-hoc superiority analysis|Wilcoxon (Mann-Whitney)|||The intra-individual difference in median percentage of wound epithelialization was tested using a two-sided Wilcoxon test.||||=0.21
72413944|NCT01949480|144336893|NON_INFERIORITY|To detect an effect size of 0.92 SD units with a power of 81% and alpha level of 0.05, a total sample size of 40 patients (20 patients/group) was calculated.||||||0.574|||||||t-test, 2 sided|||||||0.574
72413945|NCT01949480|144336894|NON_INFERIORITY|To detect an effect size of 0.92 SD units with a power of 81% and alpha level of 0.05, a total sample size of 40 patients (20 patients/group) was calculated.||||||0.913|||||||t-test, 2 sided|||||||0.913
72586531|NCT01294241|144704686|SUPERIORITY_OR_OTHER|||||||0.33||||||Post-hoc superiority analysis|Wilcoxon (Mann-Whitney)|||The intra-individual difference in median percentage of wound epithelialization was tested using a two-sided Wilcoxon test.||||0.33
72413946|NCT01949480|144336895|NON_INFERIORITY|To detect an effect size of 0.92 SD units with a power of 81% and alpha level of 0.05, a total sample size of 40 patients (20 patients/group) was calculated.||||||0.783|||||||t-test, 2 sided|||||||0.783
72413947|NCT04313634|144336903|SUPERIORITY|||||||0.611|||||||Wilcoxon (Mann-Whitney)|||||||0.611
72413948|NCT04313634|144336904|SUPERIORITY|||||||0.02|||||||Wilcoxon (Mann-Whitney)|||||||0.020
72413949|NCT04313634|144336905|SUPERIORITY|||||||0.024|||||||Wilcoxon (Mann-Whitney)|||||||0.024
72413950|NCT04313634|144336906|SUPERIORITY|||||||0.149|||||||Wilcoxon (Mann-Whitney)|||||||0.149
72413951|NCT04313634|144336908|SUPERIORITY|||||||0.953|||||||Wilcoxon (Mann-Whitney)|||||||0.953
72413952|NCT03825380|144336957|NON_INFERIORITY|"Primary tested:Non-inferiority of T4032 to Lumigan® on the change from baseline in IOP using a MMRM. 3 independent models will be performed, one for each time point (8:00, 10:00~\& 16:00). The 95% CI for treatment effect (difference T4032 - Lumigan) will be estimated at Wk 12. NI will be achieved if the upper bound of the 95% CI for the difference between treatment groups (T4032 - Lumigan) is lower than the margin of +1.5 mmHg for each of the 3 time points 8:00, 10:00 \& 16:00."|Adjusted Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.23||0.453|TWO_SIDED|95.0|-0.62|0.28|||Mixed Models Analysis|||||0.28|-0.62|0.453
72413953|NCT02105948|144336959|SUPERIORITY||Rate ratio (mepolizumab/placebo)|0.82|||=|0.036|TWO_SIDED|95.0|0.68|0.98||Adjusted p-value to account for two treatment comparisons|Negative binomial model||Analysis using a negative binomial model with covariates of treatment, geographic region, no.of moderate/severe exacerbations in previous year, Baseline percent predicted for FEV1,smoking status and offset of log (time in on-and off-treatment period)|||0.98|0.68|=0.036
72413954|NCT02105948|144336959|SUPERIORITY||Rate ratio (mepolizumab/placebo)|0.82|||=|0.029|TWO_SIDED|95.0|0.68|0.98||Unadjusted p-value.|Negative binomial mode||Analysis using a negative binomial model with covariates of treatment, geographic region, no.of moderate/severe exacerbations in previous year, Baseline percent predicted FEV1, smoking status and offset of log (time in on- and off-treatment period)|||0.98|0.68|=0.029
72413955|NCT02105948|144336960|SUPERIORITY||Rate ratio (mepolizumab/placebo)|0.98|||>|0.999|TWO_SIDED|95.0|0.85|1.12||Adjusted p-value to account for two treatment comparisons|Negative Binomial Model||Analysis using a negative binomial model with covariates of treatment, geographic region, no.of moderate/severe exacerbations in previous year, Baseline percent predicted FEV1, smoking status and offset of log (time in on- and off-treatment period)|||1.12|0.85|>0.999
72413956|NCT02105948|144336960|SUPERIORITY||Rate ratio (mepolizumab/placebo)|0.98|||=|0.731|TWO_SIDED|95.0|0.85|1.12||Unadjusted p-value.|Negative binomial mode||Analysis using a negative binomial model with covariates of treatment, geographic region, no.of moderate/severe exacerbations in previous year, Baseline percent predicted FEV1, smoking status and offset of log (time in on- and off-treatment period)|||1.12|0.85|=0.731
72586532|NCT02582242|144704708|OTHER||Treatment difference at week 24|-0.09||||0.2601|TWO_SIDED|95.0|-0.23|0.06|||Mixed model for repeated measurements||Treatment difference at week 24: BIAsp 30 (TID) - BIAsp 30 (BID). Number of subjects contributed to the statistical analysis: N=217 for BIAsp 30 (TID) and N=213 for BIAsp 30 (BID).|The analysis was based on a mixed-effect model for repeated measures including changes from baseline in HbA1c at visit 6, 10, 14, 18, 22 and 26 (in week 4, 8, 12, 16, 20 and 24, respectively). The model included treatment, strata and region as fixed factors, subject as random effect, baseline HbA1c as covariate and interaction between all fixed effects and visit, and between the covariate and visit.||0.06|-0.23|0.2601
72586533|NCT00459290|144704733|SUPERIORITY_OR_OTHER|||||||0.7912|||||||Log Rank|||||||0.7912
72586534|NCT00459290|144704734|SUPERIORITY_OR_OTHER|||||||0.1545|||||||Log Rank|||||||0.1545
72586535|NCT00459290|144704735|SUPERIORITY_OR_OTHER|||||||0.0648|||||||Log Rank|||||||0.0648
72586536|NCT02498444|144704736|OTHER||Risk Ratio (RR)|1.29||||0.03|TWO_SIDED|95.0|1.02|1.64|||Poisson regression|Poisson regression model demonstrating associations between treatment groups and outcomes (chest tube duration in days and length of stay in days)||||1.64|1.02|0.03
72586537|NCT02498444|144704737|OTHER||Risk Ratio (RR)|1.23||||0.0498|TWO_SIDED|95.0|1.0|1.51||Poisson regression model demonstrating associations between treatment groups and outcomes (chest tube duration in days and length of stay in days)|Poisson regression|||||1.51|1.00|0.0498
72586538|NCT02498444|144704738|OTHER|||||||0.05|||||||Unadjusted repeated measure analysis|||Between-group comparison at postoperative hour 0||||0.05
72586539|NCT02498444|144704738|OTHER||||||<|0.01|||||||Unadjusted repeated measure analysis|||Between-group comparison at postoperative hour 12||||<0.01
72586540|NCT02498444|144704738|OTHER|||||||0.14|||||||Unadjusted repeated measure analysis|||Between-group comparison at postoperative hour 24||||0.14
72586541|NCT02498444|144704739|OTHER|||||||0.23|||||||Unadjusted repeated measure analysis|||Between-group comparison at postoperative hour 0||||0.23
72586542|NCT02498444|144704739|OTHER|||||||0.27|||||||Unadjusted repeated measure analysis|||Between-group comparison at postoperative hour 12||||0.27
72586543|NCT02498444|144704739|OTHER|||||||0.65|||||||Unadjusted repeated measure analysis|||Between-group comparison at postoperative hour 24||||0.65
72586544|NCT02498444|144704740|OTHER|||||||0.37|||||||Unadjusted repeated measure analysis|||Between-group comparison at postoperative hour 0||||0.37
72586545|NCT02498444|144704740|OTHER||||||<|0.01|||||||Unadjusted repeated measure analysis|||Between-group comparison at postoperative hour 12||||<0.01
72586546|NCT02498444|144704740|OTHER|||||||0.3|||||||Unadjusted repeated measure analysis|||Between-group comparison at postoperative hour 24||||0.30
72586547|NCT02453334|144704741|OTHER||Odds Ratio (OR)|0.51||||0.0143|TWO_SIDED|95.0|0.3|0.87|||Cochran-Mantel-Haenszel|||||0.87|0.30|0.0143
72586548|NCT02453334|144704741|OTHER||Percentage difference|-15.6|||||TWO_SIDED|95.0|-28.01|-3.1||||||||-3.10|-28.01|
72586549|NCT02453334|144704743|OTHER||Odds Ratio (OR)|2.04||||0.0097|TWO_SIDED|95.0|1.19|3.5|||Cochran-Mantel-Haenszel|||||3.50|1.19|0.0097
72586550|NCT02453334|144704743|OTHER||Percentage difference|16.4|||||TWO_SIDED|95.0|4.19|28.51||||||Percentage difference||28.51|4.19|
72586551|NCT02453334|144704744|OTHER||Percentage difference|-2.7|||||TWO_SIDED|95.0|-12.85|7.45||||||||7.45|-12.85|
72586552|NCT02453334|144704744|OTHER||Odds Ratio (OR)|0.83||||0.5758|TWO_SIDED|95.0|0.43|1.6|||Cochran-Mantel-Haenszel|||Placebo group was used as the denominator for odds ratio calculation.||1.60|0.43|0.5758
72413957|NCT02105948|144336961|SUPERIORITY||Hazard ratio (Mepolizumab/placebo)|0.75|||=|0.036|TWO_SIDED|95.0|0.6|0.94||Adjusted p-value|Cox Proportional Hazards Model||Analysis performed using a Cox Proportional Hazards Model with covariates of treatment, geographic region, no. moderate/severe exacerbations in previous year, Baseline percent predicted FEV1 and smoking status|||0.94|0.60|=0.036
72586553|NCT02453334|144704745|OTHER||Odds Ratio (OR)|1.4||||0.2772|TWO_SIDED|95.0|0.76|2.56||Placebo group was used as the denominator for odds ratio calculation|Cochran-Mantel-Haenszel|||||2.56|0.76|0.2772
72586554|NCT02453334|144704745|OTHER||Percentage difference|5.7|||||TWO_SIDED|95.0|-5.01|16.43||||||||16.43|-5.01|
72586555|NCT02453334|144704746|OTHER|||||||0.0011|||||||Log Rank|P-value was estimated using logrank test stratified by country||||||0.0011
72586556|NCT02453334|144704747|OTHER||Percentage difference|0.7|||||TWO_SIDED|95.0|-7.6|9.08||||||||9.08|-7.60|
72586557|NCT02453334|144704747|OTHER||Odds Ratio (OR)|1.05||||0.8924|TWO_SIDED|95.0|0.49|2.29|||Cochran-Mantel-Haenszel|||||2.29|0.49|0.8924
72586558|NCT02453334|144704748|OTHER||Percentage difference|-9.8|||||TWO_SIDED|95.0|-20.41|0.77||||||||0.77|-20.41|
72413958|NCT02105948|144336961|SUPERIORITY||Hazard ratio (Mepolizumab/placebo)|0.75|||=|0.012|TWO_SIDED|95.0|0.6|0.94||Unadjusted p-value|Cox Proportional Hazards Model||Analysis performed using a Cox Proportional Hazards Model with covariates of treatment, geographic region, no. moderate/severe exacerbations in previous year, Baseline percent predicted FEV1 and smoking status|||0.94|0.60|=0.012
72413959|NCT02105948|144336962|SUPERIORITY||Rate ratio (mepolizumab/placebo)|1.16|||=|0.598|TWO_SIDED|95.0|0.77|1.75||Adjusted p-value|Negative binomial model||Analysis using a negative binomial model with covariates of treatment, geographic region, no. moderate/severe exacerbations in previous year, Baseline percent predicted FEV1, smoking status and offset of log (time in on- and off-treatment period).|||1.75|0.77|=0.598
72586559|NCT02453334|144704748|OTHER||Odds Ratio (OR)|0.55||||0.074|TWO_SIDED|95.0|0.28|1.06|||Cochran-Mantel-Haenszel|Placebo group was used as the denominator for odds ratio calculation.||The odds ratio (95% \[CI) and P-value of treatment effect is based on Cochran-Mantel-Haenszel (CMH) chi-squared test adjusting for country. Placebo group was used as the denominator for odds ratio calculation.||1.06|0.28|0.0740
72586560|NCT02453334|144704749|OTHER||Percentage difference|-12.1|||||TWO_SIDED|95.0|-23.31|-0.91||||||||-0.91|-23.31|
72586561|NCT02453334|144704749|OTHER||Odds Ratio (OR)|0.51||||0.0446|TWO_SIDED|95.0|0.26|0.99||The odds ratio (95% \[CI) and P-value of treatment effect is based on Cochran-Mantel-Haenszel (CMH) chi-squared test adjusting for country.|Cochran-Mantel-Haenszel|Placebo group was used as the denominator for odds ratio calculation||||0.99|0.26|0.0446
72586562|NCT02453334|144704750|OTHER||Percentage difference|-19.8|||||TWO_SIDED|95.0|-30.9|-8.69||||||||-8.69|-30.90|
72586563|NCT02453334|144704750|OTHER||Odds Ratio (OR)|0.3||||0.001|TWO_SIDED|95.0|0.14|0.63||The odds ratio (95% \[CI) and P-value of treatment effect is based on Cochran-Mantel-Haenszel (CMH) chi-squared test adjusting for country.|Cochran-Mantel-Haenszel|Placebo group was used as the denominator for odds ratio calculation.||||0.63|0.14|0.0010
72586564|NCT02453334|144704751|OTHER||Percentage difference|-21.4|||||TWO_SIDED|95.0|-33.22|-9.51||||||||-9.51|-33.22|
72586565|NCT02453334|144704751|OTHER||Odds Ratio (OR)|0.29||||0.0009|TWO_SIDED|95.0|0.13|0.61||The odds ratio (95% \[CI) and P-value of treatment effect is based on Cochran-Mantel-Haenszel (CMH) chi-squared test adjusting for country|Cochran-Mantel-Haenszel||Placebo group was used as the denominator for odds ratio calculation.|||0.61|0.13|0.0009
72586566|NCT02453334|144704752|OTHER||Percentage difference|-16.0|||||TWO_SIDED|95.0|-27.73|-4.26||||||||-4.26|-27.73|
72586567|NCT02453334|144704752|OTHER||Odds Ratio (OR)|0.34||||0.0093|TWO_SIDED|95.0|0.14|0.79||The odds ratio (95% \[CI) and P-value of treatment effect is based on Cochran-Mantel-Haenszel (CMH) chi-squared test adjusting for country.|Cochran-Mantel-Haenszel||Placebo group was used as the denominator for odds ratio calculation.|||0.79|0.14|0.0093
72586568|NCT02453334|144704753|OTHER||Percentage difference|-4.4|||||TWO_SIDED|95.0|-15.37|6.57||||||||6.57|-15.37|
72586569|NCT02453334|144704753|OTHER||Odds Ratio (OR)|0.7||||0.4786|TWO_SIDED|95.0|0.26|1.89||The odds ratio (95% \[CI) and P-value of treatment effect is based on Cochran-Mantel-Haenszel (CMH) chi-squared test adjusting for country.|Cochran-Mantel-Haenszel||Placebo group was used as the denominator for odds ratio calculation.|||1.89|0.26|0.4786
72586570|NCT02453334|144704754|OTHER||Percentage difference|-7.4|||||TWO_SIDED|95.0|-19.25|4.55||||||||4.55|-19.25|
72586571|NCT02453334|144704754|OTHER||Odds Ratio (OR)|0.54||||0.2084|TWO_SIDED|95.0|0.2|1.43||The odds ratio (95% \[CI) and P-value of treatment effect is based on Cochran-Mantel-Haenszel (CMH) chi-squared test adjusting for country.|Cochran-Mantel-Haenszel||Placebo group was used as the denominator for odds ratio calculation.|||1.43|0.20|0.2084
72586572|NCT02453334|144704755|OTHER||Percentage difference|3.1|||||TWO_SIDED|95.0|-9.33|15.54||||||||15.54|-9.33|
72586573|NCT02453334|144704755|OTHER||Odds Ratio (OR)|1.25||||0.6508|TWO_SIDED|95.0|0.48|3.24|||Cochran-Mantel-Haenszel|The odds ratio (95% \[CI) and P-value of treatment effect is based on Cochran-Mantel-Haenszel (CMH) chi-squared test adjusting for country.|Placebo group was used as the denominator for odds ratio calculation.|||3.24|0.48|0.6508
72586574|NCT02453334|144704757|OTHER|||||||0.0063||||||P-value was estimated using logrank test stratified by pooled sites.|Log Rank|||||||0.0063
72586575|NCT03491462|144704847|SUPERIORITY|||||||0.6208|||||||Gehan's extended Wilcoxon's test|||||||0.6208
72586576|NCT01019694|144704866|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.6|||<|0.0001||95.0|6.02|13.19|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Combivent Inhalation Aerosol||13.19|6.02|< 0.0001
72413960|NCT02105948|144336962|SUPERIORITY||Rate ratio (mepolizumab/placebo)|1.16|||=|0.479|TWO_SIDED|95.0|0.77|1.75||Unadjusted p-value|Negative binomial model||Analysis using a negative binomial model with covariates of treatment, geographic region, no. moderate/severe exacerbations in previous year, Baseline percent predicted FEV1, smoking status and offset of log (time in on- and off-treatment period).|||1.75|0.77|=0.479
72413961|NCT02105948|144336963|SUPERIORITY||Mean Difference (Mepolizumab - Placebo)|0.2|||>|0.999|TWO_SIDED|95.0|-2.8|3.2||Adjusted p-value|Mixed Model Repeated Measure Analysis||Analysis performed using mixed model repeated measures with covariates of baseline SGRQ Total Score, geographic region, smoking status, treatment and visit, plus interaction terms for visit by Baseline and visit by treatment group.|||3.2|-2.8|>0.999
72586577|NCT01019694|144704866|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.2||||0.0009||95.0|2.57|9.91|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosols||9.91|2.57|0.0009
72586578|NCT01019694|144704867|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.3||||0.0006||95.0|2.29|8.28|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Combivent Inhalation Aerosol||8.28|2.29|0.0006
72586579|NCT01019694|144704867|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.4|||<|0.0001||95.0|4.41|10.39|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosols||10.39|4.41|< 0.0001
72586580|NCT01019694|144704868|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.9|||<|0.0001||95.0|4.71|11.09|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Combivent Inhalation Aerosol||11.09|4.71|< 0.0001
72586581|NCT01019694|144704868|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.6|||<|0.0001||95.0|6.44|12.83|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosols||12.83|6.44|< 0.0001
72586582|NCT01019694|144704869|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.2|||<|0.0001||95.0|5.94|12.37|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Combivent Inhalation Aerosol||12.37|5.94|< 0.0001
72586583|NCT01019694|144704869|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.7|||<|0.0001||95.0|4.44|10.96|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosols||10.96|4.44|< 0.0001
72586584|NCT01019694|144704870|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.3|||<|0.0001||95.0|7.9|14.76|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Combivent Inhalation Aerosol||14.76|7.90|< 0.0001
72586585|NCT01019694|144704870|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.7|||<|0.0001||95.0|4.23|11.23|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosols||11.23|4.23|< 0.0001
72586586|NCT01019694|144704872|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2||||0.1167||95.0|-0.05|0.42|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Combivent Inhalation Aerosol||0.42|-0.05|0.1167
72586587|NCT01019694|144704872|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.4||||0.0026||95.0|0.13|0.59|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosols||0.59|0.13|0.0026
72586588|NCT01019694|144704873|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||0.2826||95.0|-0.11|0.38|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Combivent Inhalation Aerosol||0.38|-0.11|0.2826
72586589|NCT01019694|144704873|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.4||||0.0013||95.0|0.16|0.66|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosols||0.66|0.16|0.0013
72586590|NCT01019694|144704874|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.4||||0.0023||95.0|0.13|0.59|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Combivent Inhalation Aerosol||0.59|0.13|0.0023
72586591|NCT01019694|144704874|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.5|||<|0.0001||95.0|0.25|0.71|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosols||0.71|0.25|< 0.0001
72586592|NCT01019694|144704875|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.4||||0.0006||95.0|0.18|0.65|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Combivent Inhalation Aerosol||0.65|0.18|0.0006
72586593|NCT01019694|144704875|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.4||||0.0004||95.0|0.2|0.68|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosols||0.68|0.20|0.0004
72586594|NCT01019694|144704876|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2||||0.0673||95.0|-0.02|0.47|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Combivent Inhalation Aerosol||0.47|-0.02|0.0673
72586595|NCT01019694|144704876|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3||||0.0245||95.0|0.04|0.54|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosols||0.54|0.04|0.0245
72586596|NCT01019694|144704878|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.5695||95.0|-0.24|0.13|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Combivent Inhalation Aerosol||0.13|-0.24|0.5695
72586597|NCT01019694|144704878|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.3093||95.0|-0.28|0.09|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosols||0.09|-0.28|0.3093
72586598|NCT01019694|144704879|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.3578||95.0|-0.31|0.11|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Combivent Inhalation Aerosol||0.11|-0.31|0.3578
72586599|NCT01019694|144704879|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.7433||95.0|-0.18|0.25|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosols||0.25|-0.18|0.7433
72586600|NCT01019694|144704880|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.524||95.0|-0.29|0.15|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Combivent Inhalation Aerosol||0.15|-0.29|0.524
72586601|NCT01019694|144704880|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.3171||95.0|-0.34|0.11|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosols||0.11|-0.34|0.3171
72586602|NCT01019694|144704881|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.2499||95.0|-0.38|0.1|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Combivent Inhalation Aerosol||0.10|-0.38|0.2499
72586603|NCT01019694|144704881|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.6144||95.0|-0.31|0.18|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosols||0.18|-0.31|0.6144
72586604|NCT01019694|144704882|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||0.5142||95.0|-0.16|0.33|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Combivent Inhalation Aerosol||0.33|-0.16|0.5142
72586605|NCT01019694|144704882|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.2691||95.0|-0.39|0.11|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosols||0.11|-0.39|0.2691
72586606|NCT01019694|144704884|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.6236||95.0|-0.23|0.14|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Combivent Inhalation Aerosol||0.14|-0.23|0.6236
72586607|NCT01019694|144704884|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.3342||95.0|-0.28|0.09|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosols||0.09|-0.28|0.3342
72586608|NCT01019694|144704885|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.1884||95.0|-0.36|0.07|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Combivent Inhalation Aerosol||0.07|-0.36|0.1884
72586609|NCT01019694|144704885|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.6978||95.0|-0.17|0.26|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosols||0.26|-0.17|0.6978
72586610|NCT01019694|144704886|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.4197||95.0|-0.32|0.13|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Combivent Inhalation Aerosol||0.13|-0.32|0.4197
72586611|NCT01019694|144704886|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.3949||95.0|-0.33|0.13|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosols||0.13|-0.33|0.3949
72586612|NCT01019694|144704887|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.299||95.0|-0.38|0.12|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Combivent Inhalation Aerosol||0.12|-0.38|0.299
72586613|NCT01019694|144704887|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2||||0.1404||95.0|-0.44|0.06|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosols||0.06|-0.44|0.1404
72586614|NCT01019694|144704888|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.463||95.0|-0.36|0.16|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Combivent Inhalation Aerosol||0.16|-0.36|0.463
72586615|NCT01019694|144704888|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||0.3824||95.0|-0.15|0.38|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosols||0.38|-0.15|0.3824
72586616|NCT01019694|144704889|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.8282||95.0|-0.036|0.045|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Combivent Inhalation Aerosol||0.045|-0.036|0.8282
72586617|NCT01019694|144704889|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01||||0.6587||95.0|-0.032|0.05|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosols||0.050|-0.032|0.6587
72586618|NCT01019694|144704890|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.04||||0.1185||95.0|-0.009|0.081|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Combivent Inhalation Aerosol||0.081|-0.009|0.1185
72586619|NCT01019694|144704890|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.03||||0.2651||95.0|-0.02|0.072|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosols||0.072|-0.020|0.2651
72586620|NCT01019694|144704891|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01||||0.5852||95.0|-0.058|0.033|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Combivent Inhalation Aerosol||0.033|-0.058|0.5852
72586621|NCT01019694|144704891|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01||||0.7242||95.0|-0.054|0.038|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosols||0.038|-0.054|0.7242
72586622|NCT01019694|144704892|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.06||||0.0328||95.0|0.005|0.11|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||||0.110|0.005|0.0328
72413962|NCT02105948|144336963|SUPERIORITY||Mean Difference (Mepolizumab - Placebo)|0.2|||=|0.901|TWO_SIDED|95.0|-2.8|3.2||Unadjusted p-value|Mixed Model Repeated Measure Analysis||Analysis performed using mixed model repeated measures with covariates of baseline SGRQ Total Score, geographic region, smoking status, treatment and visit, plus interaction terms for visit by Baseline and visit by treatment group.|||3.2|-2.8|=0.901
72586623|NCT01019694|144704892|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.8896||95.0|-0.058|0.05|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosols||0.050|-0.058|0.8896
72586624|NCT01019694|144704893|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.03||||0.402||95.0|-0.042|0.105|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Combivent Inhalation Aerosol||0.105|-0.042|0.402
72586625|NCT01019694|144704893|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.02||||0.659||95.0|-0.057|0.09|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosols||0.090|-0.057|0.659
72586626|NCT01019694|144704894|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.06||||0.0893||95.0|-0.01|0.139|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Combivent Inhalation Aerosol||0.139|-0.010|0.0893
72586627|NCT01019694|144704894|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.02||||0.5424||95.0|-0.052|0.099|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosols||0.099|-0.052|0.5424
72586628|NCT01019694|144704895|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02||||0.6396||95.0|-0.104|0.064|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Combivent Inhalation Aerosol||0.064|-0.104|0.6396
72586629|NCT01019694|144704895|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02||||0.6455||95.0|-0.106|0.066|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosols||0.066|-0.106|0.6455
72586630|NCT01019694|144704896|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.05||||0.2596||95.0|-0.038|0.141|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Combivent Inhalation Aerosol||0.141|-0.038|0.2596
72586631|NCT01019694|144704896|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02||||0.6659||95.0|-0.112|0.071|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosols||0.071|-0.112|0.6659
72586632|NCT01019694|144704898|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.476||95.0|-0.4|0.19|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Combivent Inhalation Aerosol||0.19|-0.40|0.476
72586633|NCT01019694|144704898|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.6976||95.0|-0.35|0.23|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosols||0.23|-0.35|0.6976
72586634|NCT01019694|144704899|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.9506||95.0|-0.4|0.37|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Combivent Inhalation Aerosol||0.37|-0.40|0.9506
72586635|NCT01019694|144704899|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2||||0.2362||95.0|-0.15|0.62|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosols||0.62|-0.15|0.2362
72586636|NCT01019694|144704900|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||0.5645||95.0|-0.3|0.54|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Combivent Inhalation Aerosol||0.54|-0.30|0.5645
72586637|NCT01019694|144704900|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.5||||0.0163||95.0|0.1|0.95|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosols||0.95|0.10|0.0163
72586638|NCT01019694|144704901|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2||||0.4339||95.0|-0.6|0.26|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Combivent Inhalation Aerosol||0.26|-0.60|0.4339
72586639|NCT01019694|144704901|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2||||0.4886||95.0|-0.28|0.59|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosols||0.59|-0.28|0.4886
72586640|NCT01019694|144704902|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.7637||95.0|-0.5|0.37|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Combivent Inhalation Aerosol||0.37|-0.50|0.7637
72586641|NCT01019694|144704902|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2||||0.3755||95.0|-0.24|0.65|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosols||0.65|-0.24|0.3755
72586642|NCT04244084|144704909|SUPERIORITY||Median Difference (Final Values)|-0.89||||0.0155|TWO_SIDED|95.0|-1.61|-0.17|||ANCOVA|Site used as covariate||Mean differences (MMH-407 vs. Placebo) were compared||-0.17|-1.61|0.0155
72413963|NCT02105948|144336964|SUPERIORITY||Mean Difference (Mepolizumab - Placebo)|-0.8|||>|0.999|TWO_SIDED|95.0|-2.0|0.5||Adjusted p-value|Mixed Model Repeated Measures Analysis||Analysis performed using mixed model repeated measures with covariates of baseline CAT score, geographic region, smoking status, treatment and visit, plus interaction terms for visit by Baseline and visit by treatment group.|||0.5|-2.0|>0.999
72413964|NCT02105948|144336964|SUPERIORITY||Mean Difference (Mepolizumab - Placebo)|-0.8|||=|0.244|TWO_SIDED|95.0|-2.0|0.5||Unadjusted p-value|Mixed Model Repeated Measures Analysis||Analysis performed using mixed model repeated measures with covariates of baseline CAT score, geographic region, smoking status, treatment and visit, plus interaction terms for visit by Baseline and visit by treatment group.|||0.5|-2.0|=0.244
72586643|NCT04244084|144704910|SUPERIORITY|||||||0.1839|||||||Wilcoxon (Mann-Whitney)|||||||0.1839
72586644|NCT04244084|144704911|SUPERIORITY|||||||0.064||||||Day used as independent strata.|Cochran-Mantel-Haenszel|||||||0.0640
72586645|NCT04244084|144704912|SUPERIORITY|||||||0.1927|||||||Wilcoxon (Mann-Whitney)|||||||0.1927
72586646|NCT04244084|144704913|SUPERIORITY|||||||0.0014||||||Day used as independent strata.|Cochran-Mantel-Haenszel|||||||0.0014
72586647|NCT04244084|144704914|SUPERIORITY|||||||0.2009|||||||Wilcoxon (Mann-Whitney)|||"This analysis applies to Day 1 row."||||0.2009
72586648|NCT04244084|144704914|SUPERIORITY|||||||0.4717|||||||Wilcoxon (Mann-Whitney)|||"This analysis applies to Day 2 row."||||0.4717
72586649|NCT04244084|144704914|SUPERIORITY|||||||0.5144|||||||Wilcoxon (Mann-Whitney)|||"This analysis applies to Day 3 row."||||0.5144
72586650|NCT04244084|144704915|SUPERIORITY|||||||0.62|||||||Fisher Exact|||||||0.62
72586651|NCT04244084|144704917|SUPERIORITY|||||||0.5981|||||||Kruskal-Wallis|||"This analysis applies to Systolic blood pressure/Visit 1 row."||||0.5981
72586652|NCT04244084|144704917|SUPERIORITY|||||||0.4913|||||||Kruskal-Wallis|||"This analysis applies to Systolic blood pressure/Visit 2 row."||||0.4913
72586653|NCT04244084|144704917|SUPERIORITY|||||||0.6441|||||||Kruskal-Wallis|||"This analysis applies to Systolic blood pressure/Visit 3 row."||||0.6441
72586654|NCT04244084|144704917|SUPERIORITY|||||||0.8186|||||||Kruskal-Wallis|||"This analysis applies to Diastolic blood pressure/Visit 1 row."||||0.8186
72586655|NCT04244084|144704917|SUPERIORITY|||||||0.8931|||||||Kruskal-Wallis|||"This analysis applies to Diastolic blood pressure/Visit 2 row."||||0.8931
72586656|NCT04244084|144704917|SUPERIORITY|||||||0.5887|||||||Kruskal-Wallis|||"This analysis applies to Diastolic blood pressure/Visit 3 row."||||0.5887
72586657|NCT04244084|144704918|SUPERIORITY|||||||0.4426|||||||Kruskal-Wallis|||"This analysis applies to Heart rate/Visit 1 row."||||0.4426
72586658|NCT04244084|144704918|SUPERIORITY|||||||0.5998|||||||Kruskal-Wallis|||"This analysis applies to Heart rate/Visit 2 row."||||0.5998
72586659|NCT04244084|144704918|SUPERIORITY|||||||0.971|||||||Kruskal-Wallis|||"This analysis applies to Heart rate/Visit 3 row."||||0.9710
72586660|NCT04244084|144704919|SUPERIORITY|||||||0.6197|||||||Kruskal-Wallis|||"This analysis applies to Breathing rate/Visit 1 row."||||0.6197
72586661|NCT04244084|144704919|SUPERIORITY|||||||0.7042|||||||Kruskal-Wallis|||"This analysis applies to Breathing rate/Visit 2 row."||||0.7042
72586662|NCT04244084|144704919|SUPERIORITY|||||||0.7693|||||||Kruskal-Wallis|||"This analysis applies to Breathing rate/Visit 3 row."||||0.7693
72586663|NCT04244084|144704920|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.000
72586664|NCT04632069|144704939|SUPERIORITY||Mean Difference (Final Values)|2.1|STANDARD_DEVIATION|0.4||0.009|TWO_SIDED||||||Regression, Linear|repeated measures linear regression: time periods: -14 to Day 0, Day 1-18(independent variable); daily po volumes (Dependent Variable)||Daily change in po feeding volumes expressed as po ml/kg/d \[reported as the mean daily change from Day 1 to 18 during NAC/NAC+taVNS minus baseline mean daily change Day -14 to day 0 (before treatment)\] Null hypothesis: there will be no significant difference in daily change in po feeding volume (ml/kg/d) from baseline to during treatment Power analysis: Estimated +0.2 ml/kg/d before taVNS, and +3ml/kg/d during the 18days of NAC+taVNS treatment, requiring 10 infants with power of 80%, a=0.05.||||0.009
72586665|NCT04632069|144704940|SUPERIORITY||Mean Difference (Final Values)|0.13|STANDARD_DEVIATION|0.08||0.01|TWO_SIDED||||||t-test, 2 sided|paired t-test|mean difference between \[GSH\] Day 4 of NAC and \[GSH\] at baseline|\[GSH\] at baseline compared with \[GSH\] at day 4 of NAC- by paired t-test in which each participant's \[GSH\] is compared at 2 time points Null hypothesis: the \[GSH\] in the basal ganglia will be no different after Day 4 of NAC than \[GSH\] at baseline Power calculation:With 80% power, alpha of 0.05, we would need 7 patients to show a significant change in basal ganglia \[GSH\] of 0.14 +/- 0.13mM from baseline to Day 4 of NAC (paired t-test).||||0.01
72586666|NCT03412734|144704954|OTHER||Odds Ratio (OR)|10.6|||<|0.001|TWO_SIDED|95.0|3.02|37.34||p-value is adjusted for baseline BV (Bacterial Vaginosis)|Regression, Logistic|||We hypothesized that chlorhexidine would have a lower bacterial count compared to iodine. Our sample size was calculated to be 71 patients per arm to detect a 22% difference in cultures defined as contaminated at 90 minutes from surgical preparation.||37.34|3.02|<0.001
72586667|NCT00402688|144704982|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin is a risk difference of 0.2.|Risk Difference (RD)|0.063||||||95.0|-0.089|0.215|||||Difference in success rates (levofloxacin 500mg for 4 weeks minus levofloxacin 750mg for 2 weeks ).|||0.215|-0.089|
72586668|NCT00402688|144704982|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin is a risk difference of 0.2.|Risk Difference (RD)|0.045||||||95.0|-0.106|0.195|||||Difference in success rates (levofloxacin 500mg for 4 weeks minus levofloxacin 750mg for 3 weeks).|||0.195|-0.106|
72586669|NCT00927862|144704988|NON_INFERIORITY_OR_EQUIVALENCE|Based on power calculations and feasibility, the minimum recruitment target for the randomized, PG-guided comparison was set at 500 patients. All qualifying parallel control patients were included, anticipated to number ≥1000. For hypothesis 1, the power to exclude inferiority of the modified PG arm vs standard PG arm at a margin (delta) of 5% with 250 patients per group at a 2-sided alpha \<0.05 is 87%, assuming a common standard deviation of 0.20.|Mean Difference (Final Values)|0.34|STANDARD_DEVIATION|0.2|<|0.05|TWO_SIDED|95.0||||Comparisons between groups for primary endpoints were made using the unpaired T-test.|t-test, 2 sided|||Comparisons between groups for primary endpoints were made using the unpaired T-test. All consented, randomized patients who were successfully genotyped and received at least one dose of warfarin with at least one post-dose INR were included in efficacy analyses (modified intention to treat \[mITT\]).||||<0.05
72413965|NCT02105948|144336965|SUPERIORITY||Hazard ratio (Mepolizumab/Placebo)|0.89|||>|0.999|TWO_SIDED|95.0|0.75|1.05||Adjusted p-value|Cox Proportional Hazards Model||Analysis performed using a Cox Proportional Hazards Model with covariates of treatment, geographic region, no. moderate/severe exacerbations in previous year, Baseline percent predicted FEV1 and smoking status|||1.05|0.75|>0.999
72413966|NCT02105948|144336965|SUPERIORITY||Hazard ratio (Mepolizumab/Placebo)|0.89|||=|0.16|TWO_SIDED|95.0|0.75|1.05||Unadjusted p-value|Cox Proportional Hazards Model||Analysis performed using a Cox Proportional Hazards Model with covariates of treatment, geographic region, no. moderate/severe exacerbations in previous year, Baseline percent predicted FEV1 and smoking status|||1.05|0.75|=0.160
72413967|NCT02105948|144336966|SUPERIORITY||Rate ratio (mepolizumab/placebo)|1.1|||>|0.999|TWO_SIDED|95.0|0.81|1.49||Adjusted p-value|Negative binomial model||Analysis using a negative binomial model with covariates of treatment, geographic region, no. moderate/severe exacerbations in previous year, Baseline percent predicted FEV1, smoking status and offset of log (time in on- and off-treatment period).|||1.49|0.81|>0.999
72413968|NCT02105948|144336966|SUPERIORITY||Rate ratio (mepolizumab/placebo)|1.1|||=|0.556|TWO_SIDED|95.0|0.81|1.49||Unadjusted p-value|Negative binomial model||Analysis using a negative binomial model with covariates of treatment, geographic region, no. moderate/severe exacerbations in previous year, Baseline percent predicted FEV1, smoking status and offset of log (time in on- and off-treatment period).|||1.49|0.81|=0.556
72413969|NCT02105948|144336967|SUPERIORITY||Mean difference (Mepolizumab - Placebo)|0.7|||>|0.999|TWO_SIDED|95.0|-1.5|2.9||Adjusted p-value|Mixed Model Repeated Measures Analysis||Analysis performed using mixed model repeated measures with covariates of baseline SGRQ Total Score, geographic region, smoking status, treatment and visit, plus interaction terms for visit by Baseline and visit by treatment group.|||2.9|-1.5|>0.999
72586670|NCT00820248|144705008|SUPERIORITY||Hazard Ratio (HR)|0.95||||0.83|TWO_SIDED|95.0|0.6|1.5|||Regression, Cox||Hazard ratio of panitumumab vs cisplatin|The log rank test stratified by the stratification factors at randomization was used to compare the difference in PFS between two treatment arms.||1.50|0.60|0.83
72586671|NCT00820248|144705009|SUPERIORITY||Cox Proportional Hazard|0.89||||0.66|TWO_SIDED|95.0|0.54|1.48|||Log Rank||hazard ratio for panitumumab vs cisplatin|||1.48|0.54|0.66
72586672|NCT02237196|144705017|SUPERIORITY||Mean Difference (Net)|-0.51|STANDARD_ERROR_OF_MEAN|0.5038||0.314|TWO_SIDED|95.0|-1.51|0.49|||Longitudinal repeated measures analysis|Model adjusts for Site, Baseline TNSS AUC, and Baseline Cat exposure (low vs high)||||0.49|-1.51|0.314
72586673|NCT00863343|144705041|SUPERIORITY_OR_OTHER||Sensitivity|0.82|||||TWO_SIDED|95.0|0.59|0.94|||Wilson score method||Parameter dispersion type is not applicable. Sensitivity is the proportion of the actual positives that are correctly identified as such by the MSD test.|||0.94|0.59|
72586674|NCT00863343|144705041|SUPERIORITY_OR_OTHER||Specificity|0.987|||||TWO_SIDED|95.0|0.97|0.99|||Wilson score method||Parameter dispersion type is not applicable. Sensitivity is the proportion of the actual positives that are correctly identified as such by the MSD test.|||0.99|0.97|
72586675|NCT00863343|144705042|SUPERIORITY_OR_OTHER||Sensitivity|0.81|||||TWO_SIDED|95.0|0.63|0.92|||Wilson score method||Parameter dispersion type is not applicable. Sensitivity is the proportion of the actual positives that are correctly identified as such by the MSD test.|||0.92|0.63|
72586676|NCT00863343|144705042|SUPERIORITY_OR_OTHER||Specificity|0.997|||||TWO_SIDED|95.0|0.98|1.0|||Wilson score method||Parameter dispersion type is not applicable. Sensitivity is the proportion of the actual positives that are correctly identified as such by the MSD test.|||1.0|0.98|
72586677|NCT00863343|144705043|SUPERIORITY_OR_OTHER||Sensitivity|0.88|||||TWO_SIDED|95.0|0.7|0.96|||Wilson score method||Parameter dispersion type is not applicable. Sensitivity is the proportion of the actual positives that are correctly identified as such by the MSD test.|||0.96|0.70|
72586678|NCT00863343|144705043|SUPERIORITY_OR_OTHER||Specificity|0.997||||||95.0|0.98|1.0|||Wilson score method||Parameter dispersion type is not applicable. Sensitivity is the proportion of the actual positives that are correctly identified as such by the MSD test.|||1.0|0.98|
72586679|NCT00863343|144705044|SUPERIORITY_OR_OTHER||Sensitivity|0.79|||||TWO_SIDED|95.0|0.6|0.9|||Wilson score method||Parameter dispersion type is not applicable. Sensitivity is the proportion of the actual positives that are correctly identified as such by the MSD test.|||0.90|0.60|
72586680|NCT00863343|144705044|SUPERIORITY_OR_OTHER||Specificity|0.997|||||TWO_SIDED|95.0|0.98|1.0|||Wilson score method||Parameter dispersion type is not applicable. Sensitivity is the proportion of the actual positives that are correctly identified as such by the MSD test.|||1.0|0.98|
72586681|NCT01322490|144705062|SUPERIORITY|One-sided p-value is from a stratified log-rank test for PROSTVAC-V/F-TRICOM + GM-CSF placebo vs. Placebo Control with Treatment Arm included in model. Stratification is by randomization strata.||||||0.4742||||||The overall type-one error probability for the entire trial was designed as a one-sided P=0.025. There were two main overall comparisons, which necessitated a type-one error probability to 0.0125 for each comparison using a Bonferroni correction.|Log Rank|The primary analysis method was a stratified log-rank test, and was performed using the ITT Set analyzing data according to the randomized arm.||||||0.4742
72586682|NCT01322490|144705062|SUPERIORITY|One-sided p-value is from a stratified log-rank test for PROSTVAC-V/F-TRICOM + GM-CSF vs. Placebo Control with Treatment Arm included in model. Stratification is by randomization strata.||||||0.5885||||||The overall type-one error probability for the entire trial was designed as a one-sided P=0.025. There were two main overall comparisons, which necessitated a type-one error probability to 0.0125 for each comparison using a Bonferroni correction.|Log Rank|The primary analysis method was a stratified log-rank test, and was performed using the ITT Set analyzing data according to the randomized arm.||||||0.5885
72413970|NCT02105948|144336967|SUPERIORITY||Mean difference (Mepolizumab - Placebo)|0.7|||=|0.532|TWO_SIDED|95.0|-1.5|2.9||Unadjusted p-value|Mixed Model Repeated Measures Analysis||Analysis performed using mixed model repeated measures with covariates of baseline SGRQ Total Score, geographic region, smoking status, treatment and visit, plus interaction terms for visit by Baseline and visit by treatment group.|||2.9|-1.5|=0.532
72586683|NCT01322490|144705063|SUPERIORITY|Odds Ratio and Wald 95% CI estimates are for odds of alive without event for PROSTVAC-V/F-TRICOM + GM-CSF placebo vs. Placebo Control and are from a logistic regression model with Treatment Arm included in model stratified by randomization strata.|Odds Ratio (OR)|0.9588|||||TWO_SIDED|95.0|0.7144|1.2867|||||The Alive Without Event endpoint was analyzed using stratified logistic regression. The 95% CI on the odds ratio estimate was computed as the measure of the magnitude of effect.|||1.2867|0.7144|
72586684|NCT01322490|144705063|SUPERIORITY|Odds Ratio and Wald 95% CI estimates are for odds of alive without event for PROSTVAC-V/F-TRICOM + GM-CSF vs. Placebo Control and are from a logistic regression model with Treatment Arm included in model stratified by randomization strata.|Odds Ratio (OR)|0.8941|||||TWO_SIDED|95.0|0.6647|1.2026|||||The Alive Without Event endpoint was analyzed using stratified logistic regression. The 95% CI on the odds ratio estimate was computed as the measure of the magnitude of effect.|||1.2026|0.6647|
72586685|NCT01342523|144705084|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.02||||0.825|TWO_SIDED|95.0|0.88|1.17||P-value is not adjusted for multiple comparisons.|Regression, Logistic|The logistic regression model included all 5 treatment main effects and the 10 two-way interactions as well as gender, race, and age as covariates.||Null hypothesis: No difference in 3-month abstinence rates for participants receiving CIS vs No CIS. We hypothesized that CIS would result in significantly higher abstinence rates compared to No CIS.||1.17|0.88|.825
72586686|NCT01342523|144705084|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.17||||0.028|TWO_SIDED|95.0|1.02|1.36||P-value is not adjusted for multiple comparisons|Regression, Logistic|The logistic regression model included all 5 treatment main effects and the 10 two-way interactions as well as gender, race, and age as covariates.||Null hypothesis: No difference in 3-month abstinence rates for participants receiving NRT vs No NRT. We hypothesized that NRT would result in significantly higher abstinence rates compared to No NRT.||1.36|1.02|.028
72586687|NCT01342523|144705084|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.02||||0.755|TWO_SIDED|95.0|0.85|1.13||P-value is not adjusted for multiple comparisons|Regression, Logistic|The logistic regression model included all 5 treatment main effects and the 10 two-way interactions as well as gender, race, and age as covariates.||Null hypothesis: No difference in 3-month abstinence rates for participants receiving Email Messaging vs No Email Messaging. We hypothesized that Email Messaging would result in significantly higher abstinence rates compared to No Email Messaging.||1.13|0.85|.755
72586688|NCT01342523|144705084|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.15||||0.057|TWO_SIDED|95.0|0.996|1.33||P-value is not adjusted for multiple comparisons|Regression, Logistic|The logistic regression model included all 5 treatment main effects and the 10 two-way interactions as well as gender, race, and age as covariates.||Null hypothesis: No difference in 3-month abstinence rates for participants receiving the Full SmokeFree.gov Website vs the Lite SmokeFree.gov Website . We hypothesized that the Full SmokeFree.gov Website would result in significantly higher abstinence rates compared to the LiteSmokeFree.gov Website .||1.33|0.996|.057
72586689|NCT01342523|144705084|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.96||||0.555||95.0|0.83|1.11||P-value is not adjusted for multiple comparisons|Regression, Logistic|The logistic regression model included all 5 treatment main effects and the 10 two-way interactions as well as gender, race, and age as covariates.||Null hypothesis: No difference in 3-month abstinence rates for participants receiving the Full Cessation Booklet vs the Brief Cessation Booklet We hypothesized that the Full Cessation Booklet would result in significantly higher abstinence rates compared to the Brief Cessation Booklet.||1.11|0.83|.555
72586690|NCT01303172|144705113|OTHER||Cox Proportional Hazard|0.54||||0.011|TWO_SIDED|95.0|0.33|0.87|||Log Rank|||The difference between the two treatment groups was tested with a two-sided log-rank test and a Cox regression model was used to estimate the hazard ratio (HR) and its 95% CI and associated p-value.||0.87|0.33|0.011
72586691|NCT04468347|144705123|OTHER||Mean Difference (Net)|0.16|STANDARD_ERROR_OF_MEAN|0.038|<|0.0001|TWO_SIDED||||||ANOVA|The two-way ANOVA included cognitive and amyloid status, and their interaction as fixed effects.||||||<0.0001
72413971|NCT02105948|144336968|SUPERIORITY||Mean difference (Mepolizumab - Placebo)|-0.6|||>|0.999|TWO_SIDED|95.0|-1.5|0.4||Adjusted p-value|Mixed Model Repeated Measures Analysis||Analysis performed using mixed model repeated measures with covariates of baseline CAT score, geographic region, smoking status, treatment and visit, plus interaction terms for visit by Baseline and visit by treatment group.|||0.4|-1.5|>0.999
72586692|NCT04468347|144705123|OTHER||Mean Difference (Net)|0.14|STANDARD_ERROR_OF_MEAN|0.038||0.0005|TWO_SIDED||||||ANOVA|The two-way ANOVA included cognitive and amyloid status, and their interaction as fixed effects.||||||0.0005
72586693|NCT04468347|144705123|OTHER||Mean Difference (Net)|-0.04|STANDARD_ERROR_OF_MEAN|0.033||0.2161|TWO_SIDED||||||ANOVA|The two-way ANOVA included cognitive and amyloid status, and their interaction as fixed effects.||||||0.2161
72586694|NCT04468347|144705124|OTHER|||||||0.1998|||||||Cochran-Mantel-Haenszel|||||||0.1998
72586695|NCT04468347|144705125|OTHER|||||||0.0646|||||||Cochran-Mantel-Haenszel|||||||0.0646
72586696|NCT00554515|144705126|SUPERIORITY|Comparison against historical control ORR of 14%.||||||0.042|||||||exact binomial test|||||||0.042
72586697|NCT00554515|144705127|SUPERIORITY|||||||0.39|||||||Fisher Exact|||Objective response rates were compared between ISM good and poor risk subgroups. ISM good risk ORR reported under primary endpoint.||||0.39
72586698|NCT00554515|144705128|SUPERIORITY|||||||0.0014|||||||exact binomial test|||Test against the historical ORR was conducted in the overall study population as secondary analyses.||||0.0014
72586699|NCT00554515|144705131|SUPERIORITY|||||||0.89|||||||Fisher Exact|||Objective response rates were compared between MSKCC subgroups.||||.89
72586700|NCT00554515|144705133|SUPERIORITY|||||||0.33|||||||Fisher Exact|||Objective response rates were compared between tumor type subgroups||||.33
72586701|NCT00554515|144705134|SUPERIORITY|||||||0.89|||||||Fisher Exact|||Objective response rates were compared between clear cell histology subgroups||||.89
72586702|NCT00554515|144705135|SUPERIORITY|||||||0.19|||||||Fisher Exact|||Objective response rates were compared between CA-9 score subgroups||||.19
72586703|NCT00554515|144705136|SUPERIORITY|||||||0.01|||||||Fisher Exact|||Objective response rates were compared between PD-L1 tumor subgroups||||0.01
72586704|NCT00554515|144705137|SUPERIORITY|||||||0.08|||||||Fisher Exact|||Objective response rates were compared between B7-H3 tumor subgroups||||.08
72586705|NCT00554515|144705138|SUPERIORITY|||||||0.28|||||||Fisher Exact|||Objective response rates were compared between CA-9 SNP subgroups||||.28
72586706|NCT00665431|144705141|NON_INFERIORITY_OR_EQUIVALENCE|Non-Inferiority margin (NI) margin of 10mm between Arm 1 and Arm 2 (NI design uses confidence intervals, not p-values)|Mean Difference (Final Values)|-1.3|||||TWO_SIDED|95.0|-5.94|3.34|||ANCOVA|||||3.34|-5.94|
72586707|NCT00665431|144705142|NON_INFERIORITY_OR_EQUIVALENCE|Non-Inferiority (NI) margin of 10mm between Arm 1 and Arm 2 (NI design uses confidence intervals, not p-values)|Mean Difference (Final Values)|-2.11|||||TWO_SIDED|95.0|-6.82|2.6|||ANCOVA|||||2.60|-6.82|
72586708|NCT00665431|144705143|NON_INFERIORITY_OR_EQUIVALENCE|Non-Inferiority (NI) margin of 10mm between Arm 1 and Arm 2 (NI design uses confidence intervals, not p-values)|Mean Difference (Final Values)|3.45|||||TWO_SIDED|95.0|-1.41|8.31|||ANCOVA|||||8.31|-1.41|
72586709|NCT02915705|144705176|SUPERIORITY||LS Mean Difference|1.14|||<|0.0001|TWO_SIDED|95.0|0.83|1.45|||ANCOVA|||Least squares (LS) mean, standard error (SE), confidence interval (CI), and 2-sided p value per ANCOVA model, which included RGI-C as the dependent variable, treatment group and baseline age stratification factor as independent variables and baseline RSS score as a continuous covariate.||1.45|0.83|< 0.0001
72586710|NCT02915705|144705177|SUPERIORITY||Odds Ratio (OR)|39.1|||<|0.0001|TWO_SIDED|95.0|7.2|211.7||Odds ratio, CI, and 2-sided p-value were per logistic regression model, which included treatment group and baseline age stratification factor as independent variables and baseline RSS score as a continuous covariate.|Regression, Logistic|||||211.7|7.2|< 0.0001
72586711|NCT02915705|144705178|SUPERIORITY||Odds Ratio (OR)|34.1||||0.0002|TWO_SIDED|95.0|5.6|206.3||Odds ratio, CI, and 2-sided p-value were per generalized linear mixed model, which includes treatment, visit, treatment by visit interaction and baseline age stratification factor as factors, baseline RSS total score as a continuous covariate.|generalized linear mixed model|||||206.3|5.6|0.0002
72586712|NCT02915705|144705179|SUPERIORITY||difference in LS means|1.02|||<|0.0001|TWO_SIDED|95.0|0.72|1.33|||GEE model|||Per generalized estimating equation (GEE) model, which included RGI-C as the dependent variable, treatment, visit, treatment by visit interaction and baseline age stratification factor as factors, baseline RSS score as a continuous covariate, with exchangeable covariate structure.||1.33|0.72|< 0.0001
72586713|NCT02915705|144705180|SUPERIORITY||LS Mean Difference|-1.34|||<|0.0001|TWO_SIDED|95.0|-1.74|-0.94||LS mean, SE, CI, and 2-sided p value per ANCOVA model, which included treatment group and baseline age stratification factor as independent variables and baseline RSS score as a continuous covariate.|ANCOVA|||||-0.94|-1.74|< 0.0001
72586714|NCT02915705|144705181|SUPERIORITY||difference in LS means|-1.21|||<|0.0001|TWO_SIDED|95.0|-1.59|-0.83||LS mean, SE, CI, and 2-sided p value per GEE model, which included treatment, visit, treatment by visit interaction and baseline age stratification factor as factors, baseline RSS score as a continuous covariate.|GEE model|||||-0.83|-1.59|< 0.0001
72586715|NCT02915705|144705182|SUPERIORITY||LS Mean Difference|0.4||||0.0162|TWO_SIDED|95.0|0.07|0.72||LS mean, SE, CI, and 2-sided p value per GEE model, which included treatment, visit, treatment by visit interaction, and baseline age stratification factor as factors; and baseline RSS score as a continuous covariate.|GEE model|||||0.72|0.07|0.0162
72586716|NCT02915705|144705183|SUPERIORITY||difference in LS means|0.97|||<|0.0001|TWO_SIDED|95.0|0.57|1.37||LS mean, SE, CI, and 2-sided p value per GEE model, which included treatment, visit, treatment by visit interaction, and baseline age stratification factor as factors; and baseline RSS score as a continuous covariate.|GEE model|||||1.37|0.57|< 0.0001
72586717|NCT02915705|144705184|SUPERIORITY||LS Mean Difference|0.12||||0.0408|TWO_SIDED|95.0|0.01|0.24|||GEE model|||LS mean, SE, CI, and 2-sided p value per GEE model, which included change from baseline for recumbent length/standing height Z score as the dependent variable, treatment group, visit, interaction between treatment group by visit and baseline RSS stratification as factors, age and baseline recumbent length/standing height Z score as continuous covariates, with exchangeable covariance structure.||0.24|0.01|0.0408
72586718|NCT02915705|144705185|SUPERIORITY||difference in LS means|0.14||||0.049|TWO_SIDED|95.0|0.0|0.29|||GEE model|||LS mean, SE, CI, and 2-sided p value per GEE model, which included change from baseline for recumbent length/standing height Z score as the dependent variable, treatment group, visit, interaction between treatment group by visit and baseline RSS stratification as factors, age and baseline recumbent length/standing height Z score as continuous covariates, with exchangeable covariance structure.||0.29|0.00|0.0490
72586719|NCT02915705|144705186|SUPERIORITY||difference in LS means|1.02||||0.0386|TWO_SIDED|95.0|0.06|1.99|||ANCOVA|||LS mean, SE, CI, and 2-sided p value per ANCOVA model, which included change from baseline for growth velocity Z score as the dependent variable, treatment group and baseline RSS total score stratification as factors, baseline Z score and age as continuous covariates.||1.99|0.06|0.0386
72586720|NCT02915705|144705187|SUPERIORITY||difference in LS means|1.12||||0.0047|TWO_SIDED|95.0|0.37|1.88|||ANCOVA|||LS mean, SE, CI, and 2-sided p value per ANCOVA model, which included change from baseline for growth velocity Z score as the dependent variable, treatment group and baseline RSS total score stratification as factors, baseline Z score and age as continuous covariates.||1.88|0.37|0.0047
72586721|NCT02915705|144705188|SUPERIORITY||difference|1.04|||<|0.0001|TWO_SIDED|95.0|0.81|1.27|||GEE model||Difference (Burosumab - Oral Phosphate/Active Vitamin D)|Week 1||1.27|0.81|< 0.0001
72586722|NCT02915705|144705188|SUPERIORITY||difference|1.03|||<|0.0001|TWO_SIDED|95.0|0.79|1.27|||GEE model||Difference (Burosumab - Oral Phosphate/Active Vitamin D)|Week 4||1.27|0.79|< 0.0001
72586723|NCT02915705|144705188|SUPERIORITY||difference|0.78|||<|0.0001|TWO_SIDED|95.0|0.58|0.97|||GEE model||Difference (Burosumab - Oral Phosphate/Active Vitamin D)|Week 8||0.97|0.58|< 0.0001
72586724|NCT02915705|144705188|SUPERIORITY||difference|0.63|||<|0.0001|TWO_SIDED|95.0|0.44|0.81|||GEE model||Difference (Burosumab - Oral Phosphate/Active Vitamin D)|Week 16||0.81|0.44|< 0.0001
72586725|NCT02915705|144705188|SUPERIORITY||difference|0.51|||<|0.0001|TWO_SIDED|95.0|0.3|0.72|||GEE model||Difference (Burosumab - Oral Phosphate/Active Vitamin D)|Week 24||0.72|0.30|< 0.0001
72586726|NCT02915705|144705188|SUPERIORITY||difference|0.7|||<|0.0001|TWO_SIDED|95.0|0.51|0.89|||GEE model|||Week 32||0.89|0.51|< 0.0001
72586727|NCT02915705|144705188|SUPERIORITY||difference|0.71|||<|0.0001|TWO_SIDED|95.0|0.51|0.91|||GEE model||Difference (burosumab - Oral Phosphate/Active Vitamin D)|Week 40||0.91|0.51|< 0.0001
72586728|NCT02915705|144705188|SUPERIORITY||difference|0.61|||<|0.0001|TWO_SIDED|95.0|0.39|0.82|||GEE model|||Week 52||0.82|0.39|< 0.0001
72586729|NCT02915705|144705188|SUPERIORITY||difference|0.69|||<|0.0001|TWO_SIDED|95.0|0.49|0.9|||GEE model|||Week 64||0.90|0.49|< 0.0001
72586730|NCT02915705|144705190|SUPERIORITY||difference in LS means|0.74|||<|0.0001|TWO_SIDED|95.0|0.58|0.91|||ANCOVA||Difference (KRN23 - Oral Phosphate/Active Vitamin D)|||0.91|0.58|< 0.0001
72586731|NCT02915705|144705193|SUPERIORITY||difference|48.27|||<|0.0001|TWO_SIDED|95.0|36.53|60.02|||GEE model||Difference (Burosumab - Oral Phosphate/Active Vitamin D)|Week 1||60.02|36.53|< 0.0001
72586732|NCT02915705|144705193|SUPERIORITY||difference|21.09|||<|0.0001|TWO_SIDED|95.0|12.01|30.16|||GEE model||Difference (Burosumab - Oral Phosphate/Active Vitamin D)|Week 4||30.16|12.01|< 0.0001
72586733|NCT02915705|144705193|SUPERIORITY||difference|15.75||||0.001|TWO_SIDED|95.0|6.35|25.15|||GEE model||Difference (Burosumab - Oral Phosphate/Active Vitamin D)|Week 8||25.15|6.35|0.0010
72586734|NCT02915705|144705193|SUPERIORITY||difference|12.97||||0.0078|TWO_SIDED|95.0|3.41|22.53|||GEE model||Difference (Burosumab - Oral Phosphate/Active Vitamin D)|Week 16||22.53|3.41|0.0078
72586735|NCT02915705|144705193|SUPERIORITY||difference|10.89||||0.0101|TWO_SIDED|95.0|2.59|19.19|||GEE model||Difference (Burosumab - Oral Phosphate/Active Vitamin D)|Week 24||19.19|2.59|0.0101
72586736|NCT02915705|144705193|SUPERIORITY||difference|6.23||||0.1165|TWO_SIDED|95.0|-1.55|14.02|||GEE model||Difference (Burosumab - Oral Phosphate/Active Vitamin D)|Week 32||14.02|-1.55|0.1165
72586737|NCT02915705|144705193|SUPERIORITY||difference|11.21||||0.0317|TWO_SIDED|95.0|0.98|21.44|||GEE model||Difference (Burosumab - Oral Phosphate/Active Vitamin D)|Week 40||21.44|0.98|0.0317
72586738|NCT02915705|144705193|SUPERIORITY||difference|5.01||||0.3044|TWO_SIDED|95.0|-4.55|14.56|||GEE model||Difference (Burosumab - Oral Phosphate/Active Vitamin D)|Week 52||14.56|-4.55|0.3044
72586739|NCT02915705|144705193|SUPERIORITY||difference|8.7||||0.0145|TWO_SIDED|95.0|1.72|15.68|||GEE model||Difference (Burosumab - Oral Phosphate/Active Vitamin D|Week 64||15.68|1.72|0.0145
72586740|NCT02915705|144705195|SUPERIORITY||difference|1.65|||<|0.0001|TWO_SIDED|95.0|1.28|2.02|||GEE model||Difference (Burosumab - Oral Phosphate/Active Vitamin D)|Week 4||2.02|1.28|< 0.0001
72586741|NCT02915705|144705195|SUPERIORITY||difference|1.42|||<|0.0001|TWO_SIDED|95.0|1.19|1.64|||GEE model||Difference (Burosumab - Oral Phosphate/Active Vitamin D)|Week 8||1.64|1.19|< 0.0001
72586742|NCT02915705|144705195|SUPERIORITY||difference|1.16|||<|0.0001|TWO_SIDED|95.0|0.84|1.48|||GEE model|||Week 16||1.48|0.84|< 0.0001
72586743|NCT02915705|144705195|SUPERIORITY||difference|1.11|||<|0.0001|TWO_SIDED|95.0|0.8|1.41|||GEE model||Difference (Burosumab - Oral Phosphate/Active Vitamin D)|Week 24||1.41|0.80|< 0.0001
72586744|NCT02915705|144705195|SUPERIORITY||difference|1.24|||<|0.0001|TWO_SIDED|95.0|0.98|1.51|||GEE model|||Week 32||1.51|0.98|< 0.0001
72586745|NCT02915705|144705195|SUPERIORITY||difference|1.35|||<|0.0001|TWO_SIDED|95.0|1.1|1.6|||GEE model||Difference (Burosumab - Oral Phosphate/Active Vitamin D)|Week 40||1.60|1.10|< 0.0001
72586746|NCT02915705|144705195|SUPERIORITY||difference|1.26|||<|0.0001|TWO_SIDED|95.0|0.97|1.54|||GEE model||Difference (Burosumab - Oral Phosphate/Active Vitamin D)|Week 52||1.54|0.97|< 0.0001
72586747|NCT02915705|144705195|SUPERIORITY||difference|1.25|||<|0.0001|TWO_SIDED|95.0|0.96|1.54|||GEE model||Difference (Burosumab - Oral Phosphate/Active Vitamin D)|Week 64||1.54|0.96|< 0.0001
72586748|NCT02915705|144705197|SUPERIORITY||difference|-92.53|||<|0.0001|TWO_SIDED|95.0|-131.4|-53.66|||GEE model||Difference (Burosumab - Oral Phosphate/Active Vitamin D)|Week 16||-53.66|-131.40|< 0.0001
72586749|NCT02915705|144705197|SUPERIORITY||difference|-85.57|||<|0.0001|TWO_SIDED|95.0|-126.37|-44.76|||GEE model||Difference (Burosumab - Oral Phosphate/Active Vitamin D)|Week 24||-44.76|-126.37|< 0.0001
72586750|NCT02915705|144705197|SUPERIORITY||difference|-95.95|||<|0.0001|TWO_SIDED|95.0|-136.05|-55.84|||GEE model||Difference (Burosumab - Oral Phosphate/Active Vitamin D)|Week 40||-55.84|-136.05|< 0.0001
72586751|NCT02915705|144705197|SUPERIORITY||difference|-111.28|||<|0.0001|TWO_SIDED|95.0|-152.08|-70.49|||GEE model||Difference (Burosumab - Oral Phosphate/Active Vitamin D)|Week 52||-70.49|-152.08|< 0.0001
72586752|NCT02915705|144705197|SUPERIORITY||difference|-146.56|||<|0.0001|TWO_SIDED|95.0|-191.61|-101.52|||GEE model||Difference (Burosumab - Oral Phosphate/Active Vitamin D)|Week 64||-101.52|-191.61|< 0.0001
72586753|NCT02915705|144705200|SUPERIORITY||difference in LS means|-5.02||||0.0212|TWO_SIDED|95.0|-9.29|-0.75|||GEE model|||Pain Interference Domain. 2-sided p value per GEE model, which included change from baseline for the parameter as the dependent variable, treatment group, visit, interaction between treatment group by visit, baseline age and baseline RSS stratification as factors, baseline parameter measure as a covariate, with exchangeable covariance structure.||-0.75|-9.29|0.0212
72586754|NCT02915705|144705200|SUPERIORITY||difference in LS means|2.68||||0.1009|TWO_SIDED|95.0|-0.52|5.89|||GEE model|||Physical Function Mobility Domain. 2-sided p value per GEE model, which included change from baseline for the parameter as the dependent variable, treatment group, visit, interaction between treatment group by visit, baseline age and baseline RSS stratification as factors, baseline parameter measure as a covariate, with exchangeable covariance structure.||5.89|-0.52|0.1009
72586755|NCT02915705|144705200|SUPERIORITY||difference in LS means|-3.25||||0.1676|TWO_SIDED|95.0|-7.86|1.37|||GEE model|||Fatigue Domain. 2-sided p value per GEE model, which included change from baseline for the parameter as the dependent variable, treatment group, visit, interaction between treatment group by visit, baseline age and baseline RSS stratification as factors, baseline parameter measure as a covariate, with exchangeable covariance structure.||1.37|-7.86|0.1676
72586756|NCT02915705|144705201|SUPERIORITY||difference in LS means|-2.26||||0.3091|TWO_SIDED|95.0|-6.61|2.09|||GEE model|||Pain Interference Domain. 2-sided p value per GEE model, which included change from baseline for the parameter as the dependent variable, treatment group, visit, interaction between treatment group by visit, baseline age and baseline RSS stratification as factors, baseline parameter measure as a covariate, with exchangeable covariance structure.||2.09|-6.61|0.3091
72586757|NCT02915705|144705201|SUPERIORITY||difference in LS means|1.9||||0.3145|TWO_SIDED|95.0|-1.8|5.59|||GEE model|||Physical Function Mobility Domain. 2-sided p value per GEE model, which included change from baseline for the parameter as the dependent variable, treatment group, visit, interaction between treatment group by visit, baseline age and baseline RSS stratification as factors, baseline parameter measure as a covariate, with exchangeable covariance structure.||5.59|-1.80|0.3145
72586758|NCT02915705|144705201|SUPERIORITY||difference in LS means|-1.08||||0.681|TWO_SIDED|95.0|-6.21|4.06|||GEE model|||Fatigue Domain. 2-sided p value per GEE model, which included change from baseline for the parameter as the dependent variable, treatment group, visit, interaction between treatment group by visit, baseline age and baseline RSS stratification as factors, baseline parameter measure as a covariate, with exchangeable covariance structure.||4.06|-6.21|0.6810
72586759|NCT02915705|144705202|SUPERIORITY||Difference in LS Means|0.01||||0.9862|TWO_SIDED|95.0|-0.79|0.8|||GEE model|||GEE model includes change from baseline for FPS-R as the dependent variable, treatment group, visit, interaction between treatment group by visit and baseline RSS stratification as factors, baseline FPS-R as a covariate, with exchangeable covariance structure. The LS Mean, SE, 95% CI and 2-sided p-value are from the GEE model.||0.80|-0.79|0.9862
72586760|NCT02915705|144705203|SUPERIORITY||difference in LS means|0.05||||0.8786|TWO_SIDED|95.0|-0.58|0.68|||GEE model|||GEE model includes change from baseline for FPS-R as the dependent variable, treatment group, visit, interaction between treatment group by visit and baseline RSS stratification as factors, baseline FPS-R as a covariate, with exchangeable covariance structure. The LS Mean, SE, 95% CI and 2-sided p-value are from the GEE model.||0.68|-0.58|0.8786
72586761|NCT02915705|144705204|SUPERIORITY||difference in LS means|43.46||||0.0514|TWO_SIDED|95.0|-0.26|87.17|||GEE model|||2-sided p value per GEE model, which included change from baseline for the parameter as the dependent variable, treatment group, visit, interaction between treatment group by visit, baseline age and baseline RSS stratification as factors, baseline parameter measure as a covariate, with exchangeable covariance structure.||87.17|-0.26|0.0514
72586762|NCT02915705|144705205|SUPERIORITY||difference in LS means|45.55||||0.0399|TWO_SIDED|95.0|2.09|89.02|||GEE model|||2-sided p value per GEE model, which included change from baseline for the parameter as the dependent variable, treatment group, visit, interaction between treatment group by visit, baseline age and baseline RSS stratification as factors, baseline parameter measure as a covariate, with exchangeable covariance structure.||89.02|2.09|0.0399
72586763|NCT02915705|144705206|SUPERIORITY||difference in LS means|6.72||||0.0633|TWO_SIDED|95.0|-0.37|13.82|||GEE model|||2-sided p value per GEE model, which included change from baseline for the parameter as the dependent variable, treatment group, visit, interaction between treatment group by visit, baseline age and baseline RSS stratification as factors, baseline parameter measure as a covariate, with exchangeable covariance structure.||13.82|-0.37|0.0633
72586764|NCT02915705|144705207|SUPERIORITY||difference in LS means|7.27||||0.0496|TWO_SIDED|95.0|0.01|14.52|||GEE model|||2-sided p value per GEE model, which included change from baseline for the parameter as the dependent variable, treatment group, visit, interaction between treatment group by visit, baseline age and baseline RSS stratification as factors, baseline parameter measure as a covariate, with exchangeable covariance structure.||14.52|0.01|0.0496
72586765|NCT00150488|144705210|OTHER|Compared to baseline|||||<|0.001|||||||Chi-squared|||||||<0.001
72586766|NCT03291431|144705213|OTHER|Chi-Square comparison of frequencies|Pearson Chi-Square|0.17||||0.99|TWO_SIDED|||||A p-value of \<0.05 is considered statistically significant.|Chi-squared|||||||0.99
72586767|NCT03291431|144705214|OTHER||Slope|-0.2||||0.68|TWO_SIDED|95.0||||p \< .05 considered statistically significant.|Mixed Models Analysis||Rate of change compared between groups using linear mixed modeling.|Linear mixed modeling||||0.68
72586768|NCT03291431|144705215|OTHER|||||||0.34||||||p-value \< .05 considered statistically significant.|Mixed Models Analysis|||||||0.34
72586769|NCT03291431|144705216|OTHER|Linear mixed modeling|Slope|-1.99||||0.7|TWO_SIDED|||||p \< .05 considered statistically significant.|Mixed Models Analysis||Rate of change compared between groups using linear mixed modeling.|||||0.70
72586770|NCT03291431|144705217|OTHER||Slope|0.3||||0.11|TWO_SIDED|||||p \< .05 considered statistically significant.|Mixed Models Analysis|||Linear mixed modeling||||0.11
72586771|NCT00550745|144705225|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.26||||||95.0|0.91|1.73|||||Relative risk (ZOSTAVAX™/placebo) of proportion of subjects reporting ≥ 1 serious AE through 42 Days postvaccination and 95% Confidence Interval were based on Miettinen and Nurminen \[Comparative analysis of two rates. Stat Med 1985;4:213-26\] method.|||1.73|0.91|
72586772|NCT00550745|144705226|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.13||||||95.0|0.98|1.32|||||Relative risk (ZOSTAVAX™/placebo) of proportion of subjects reporting ≥ 1 serious AE through 6 months postvaccination and 95% Confidence Interval were based on Miettinen and Nurminen \[Comparative analysis of two rates. Stat Med 1985;4:213-26\] method.|||1.32|0.98|
72586773|NCT03850483|144705227|SUPERIORITY||Least square (LS) mean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.65||0.1641|TWO_SIDED|90.0|-1.71|0.43||Multiplicity adjustment comparing 6 different treatment arms was performed only for the primary endpoint using Hochberg step-up procedure to maintain overall familywise error rate at 5% level.|ANCOVA|||||0.43|-1.71|0.1641
72586774|NCT03850483|144705227|SUPERIORITY||LS mean difference|0.2|STANDARD_ERROR_OF_MEAN|0.65||0.61|TWO_SIDED|90.0|-0.89|1.26||Multiplicity adjustment comparing 6 different treatment arms was performed only for the primary endpoint using Hochberg step-up procedure to maintain overall familywise error rate at 5% level.|ANCOVA|||||1.26|-0.89|0.6100
72586775|NCT03850483|144705227|SUPERIORITY||LS mean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.65||0.1686|TWO_SIDED|90.0|-1.7|0.45||Multiplicity adjustment comparing 6 different treatment arms was performed only for the primary endpoint using Hochberg step-up procedure to maintain overall familywise error rate at 5% level.|ANCOVA|||||0.45|-1.70|0.1686
72586776|NCT03850483|144705227|SUPERIORITY||LS mean difference|-0.8|STANDARD_ERROR_OF_MEAN|0.64||0.1051|TWO_SIDED|90.0|-1.87|0.25||Multiplicity adjustment comparing 6 different treatment arms was performed only for the primary endpoint using Hochberg step-up procedure to maintain overall familywise error rate at 5% level.|ANCOVA|||||0.25|-1.87|0.1051
72586777|NCT03850483|144705227|SUPERIORITY||LS mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.68||0.3583|TWO_SIDED|90.0|-1.37|0.88||Multiplicity adjustment comparing 6 different treatment arms was performed only for the primary endpoint using Hochberg step-up procedure to maintain overall familywise error rate at 5% level.|ANCOVA|||||0.88|-1.37|0.3583
72586778|NCT03850483|144705227|SUPERIORITY||LS mean difference|-0.8|STANDARD_ERROR_OF_MEAN|0.66||0.1131|TWO_SIDED|90.0|-1.88|0.29||Multiplicity adjustment comparing 6 different treatment arms was performed only for the primary endpoint using Hochberg step-up procedure to maintain overall familywise error rate at 5% level.|ANCOVA|||||0.29|-1.88|0.1131
72586779|NCT03850483|144705227|SUPERIORITY||LS mean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.64||0.1812|TWO_SIDED|90.0|-1.64|0.47||Multiplicity adjustment comparing 6 different treatment arms was performed only for the primary endpoint using Hochberg step-up procedure to maintain overall familywise error rate at 5% level.|ANCOVA|||||0.47|-1.64|0.1812
72586780|NCT03850483|144705228|SUPERIORITY||Risk Difference (RD)|3.4||||0.3747|TWO_SIDED|90.0|-10.6|17.9|||Chan and Zhang method|||||17.9|-10.6|0.3747
72586781|NCT03850483|144705228|SUPERIORITY||Risk Difference (RD)|8.5||||0.243|TWO_SIDED|90.0|-6.6|25.9|||Chan and Zhang method|||||25.9|-6.6|0.2430
72586782|NCT03850483|144705228|SUPERIORITY||Risk Difference (RD)|3.4||||0.3747|TWO_SIDED|90.0|-10.6|17.9|||Chan and Zhang method|||||17.9|-10.6|0.3747
72586783|NCT03850483|144705228|SUPERIORITY||Risk Difference (RD)|14.5||||0.0665|TWO_SIDED|0.0665|-1.3|31.5|||Chan and Zhang method|||||31.5|-1.3|0.0665
72586784|NCT03850483|144705228|SUPERIORITY||Risk Difference (RD)|6.1||||0.3423|TWO_SIDED|90.0|-12.1|25.5|||Chan and Zhang method|||||25.5|-12.1|0.3423
72586785|NCT03850483|144705228|SUPERIORITY||Risk Difference (RD)|12.9||||0.1271|TWO_SIDED|90.0|-4.7|30.9|||Chan and Zhang method|||||30.9|-4.7|0.1271
72586786|NCT03850483|144705228|SUPERIORITY||Risk Difference (RD)|3.2||||0.401|TWO_SIDED|90.0|-13.2|21.1|||Chan and Zhang method|||||21.1|-13.2|0.4010
72586787|NCT03850483|144705229|SUPERIORITY||Risk Difference (RD)|-0.1||||0.4225|TWO_SIDED|90.0|-11.2|10.4|||Chan and Zhang method|||Week 1||10.4|-11.2|0.4225
72586788|NCT03850483|144705229|SUPERIORITY||Risk Difference (RD)|-3.1||||0.7483|TWO_SIDED|90.0|-14.0|5.0|||Chan and Zhang method|||Week 1||5.0|-14.0|0.7483
72586789|NCT03850483|144705229|SUPERIORITY||Risk Difference (RD)|-3.1||||0.7539|TWO_SIDED|90.0|-14.0|4.8|||Chan and Zhang method|||Week 1||4.8|-14.0|0.7539
72586790|NCT03850483|144705229|SUPERIORITY||Risk Difference (RD)|-3.1||||0.7539|TWO_SIDED|90.0|-14.0|4.8|||Chan and Zhang method|||Week 1||4.8|-14.0|0.7539
72586791|NCT03850483|144705229|SUPERIORITY||Risk Difference (RD)|0.0||||0.5|TWO_SIDED|90.0|-6.4|8.9|||Chan and Zhang method|||Week 1||8.9|-6.4|0.5000
72586792|NCT03850483|144705229|SUPERIORITY||Risk Difference (RD)|2.9||||0.2125|TWO_SIDED|90.0|-3.4|13.2|||Chan and Zhang method|||Week 1||13.2|-3.4|0.2125
72586793|NCT03850483|144705229|SUPERIORITY||Risk Difference (RD)|2.7||||0.2267|TWO_SIDED|90.0|-3.5|12.2|||Chan and Zhang method|||Week 1||12.2|-3.5|0.2267
72586794|NCT03850483|144705229|SUPERIORITY||Risk Difference (RD)|-3.1||||0.7592|TWO_SIDED|90.0|-14.0|4.6|||Chan and Zhang method|||Week 2||4.6|-14.0|0.7592
72586795|NCT03850483|144705229|SUPERIORITY||Risk Difference (RD)|-3.1||||0.7299|TWO_SIDED|90.0|-14.0|5.5|||Chan and Zhang method|||Week 2||5.5|-14.0|0.7299
72586796|NCT03850483|144705229|SUPERIORITY||Risk Difference (RD)|-0.3||||0.4463|TWO_SIDED|90.0|-11.3|9.4|||Chan and Zhang method|||Week 2||9.4|-11.3|0.4463
72586797|NCT03850483|144705229|SUPERIORITY||Risk Difference (RD)|-3.1||||0.7539|TWO_SIDED|90.0|-14.0|4.8|||Chan and Zhang method|||Week 2||4.8|-14.0|0.7539
72586798|NCT03850483|144705229|SUPERIORITY||Risk Difference (RD)|-2.2||||0.7009|TWO_SIDED|90.0|-10.1|5.9|||Chan and Zhang method|||Week 2||5.9|-10.1|0.7009
72586799|NCT03850483|144705229|SUPERIORITY||Risk Difference (RD)|4.0||||0.2507|TWO_SIDED|90.0|-4.5|15.6|||Chan and Zhang method|||Week 2||15.6|-4.5|0.2507
72586800|NCT03850483|144705229|SUPERIORITY||Risk Difference (RD)|3.5||||0.2993|TWO_SIDED|90.0|-4.8|14.3|||Chan and Zhang method|||Week 2||14.3|-4.8|0.2993
72586801|NCT03850483|144705229|SUPERIORITY||Risk Difference (RD)|-3.1||||0.7363|TWO_SIDED|90.0|-14.0|5.5|||Chan and Zhang method|||Week 4||5.5|-14.0|0.7363
72586802|NCT03850483|144705229|SUPERIORITY||Risk Difference (RD)|0.4||||0.5369|TWO_SIDED|90.0|-10.5|12.3|||Chan and Zhang method|||Week 4||12.3|-10.5|0.5369
72586803|NCT03850483|144705229|SUPERIORITY||Risk Difference (RD)|-3.1||||0.7483|TWO_SIDED|90.0|-14.0|5.0|||Chan and Zhang method|||Week 4||5.0|-14.0|0.7483
72586804|NCT03850483|144705229|SUPERIORITY||Risk Difference (RD)|-3.1||||0.7483|TWO_SIDED|90.0|-14.0|5.0|||Chan and Zhang method|||Week 4||5.0|-14.0|0.7483
72586805|NCT03850483|144705229|SUPERIORITY||Risk Difference (RD)|-2.2||||0.599|TWO_SIDED|90.0|-13.7|11.6|||Chan and Zhang method|||Week 4||11.6|-13.7|0.5990
72586806|NCT03850483|144705229|SUPERIORITY||Risk Difference (RD)|-5.9||||0.7926|TWO_SIDED|90.0|-16.4|4.9|||Chan and Zhang method|||Week 4||4.9|-16.4|0.7926
72413972|NCT02105948|144336968|SUPERIORITY||Mean difference (Mepolizumab - Placebo)|-0.6|||=|0.252|TWO_SIDED|95.0|-1.5|0.4||Unadjusted p-value|Mixed Model Repeated Measures Analysis||Analysis performed using mixed model repeated measures with covariates of baseline CAT score, geographic region, smoking status, treatment and visit, plus interaction terms for visit by Baseline and visit by treatment group.|||0.4|-1.5|=0.252
72586807|NCT03850483|144705229|SUPERIORITY||Risk Difference (RD)|3.2||||0.3402|TWO_SIDED|90.0|-9.0|17.6|||Chan and Zhang method|||Week 4||17.6|-9.0|0.3402
72413973|NCT01934218|144336972|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.988|TWO_SIDED|95.0|-2.7|2.7|||Basic longitudinal model|||||2.7|-2.7|0.988
72586808|NCT03850483|144705229|SUPERIORITY||Risk Difference (RD)|-3.2||||0.7364|TWO_SIDED|90.0|-14.4|5.7|||Chan and Zhang method|||Week 6||5.7|-14.4|0.7364
72586809|NCT03850483|144705229|SUPERIORITY||Risk Difference (RD)|4.2||||0.3009|TWO_SIDED|90.0|-7.4|17.7|||Chan and Zhang method|||Week 6||17.7|-7.4|0.3009
72586810|NCT03850483|144705229|SUPERIORITY||Risk Difference (RD)|3.2||||0.34|TWO_SIDED|90.0|-8.1|15.9|||Chan and Zhang method|||Week 6||15.9|-8.1|0.3400
72586811|NCT03850483|144705229|SUPERIORITY||Risk Difference (RD)|7.1||||0.1631|TWO_SIDED|90.0|-4.8|21.1|||Chan and Zhang method|||Week 6||21.1|-4.8|0.1631
72586812|NCT03850483|144705229|SUPERIORITY||Risk Difference (RD)|-3.2||||0.6214|TWO_SIDED|90.0|-17.8|13.0|||Chan and Zhang method|||Week 6||13.0|-17.8|0.6214
72586813|NCT03850483|144705229|SUPERIORITY||Risk Difference (RD)|-3.2||||0.6214|TWO_SIDED|90.0|-17.8|13.0|||Chan and Zhang method|||Week 6||13.0|-17.8|0.6214
72586814|NCT03850483|144705229|SUPERIORITY||Risk Difference (RD)|-3.5||||0.6413|TWO_SIDED|90.0|-17.9|11.7|||Chan and Zhang method|||Week 6||11.7|-17.9|0.6413
72586815|NCT03850483|144705229|SUPERIORITY||Risk Difference (RD)|0.0||||0.5|TWO_SIDED|90.0|-13.1|13.1|||Chan and Zhang method|||Week 8||13.1|-13.1|0.5000
72586816|NCT03850483|144705229|SUPERIORITY||Risk Difference (RD)|0.7||||0.5134|TWO_SIDED|90.0|-12.6|15.2|||Chan and Zhang method|||Week 8||15.2|-12.6|0.5134
72586817|NCT03850483|144705229|SUPERIORITY||Risk Difference (RD)|-0.2||||0.4468|TWO_SIDED|90.0|-13.4|12.5|||Chan and Zhang method|||Week 8||12.5|-13.4|0.4468
72586818|NCT03850483|144705229|SUPERIORITY||Risk Difference (RD)|7.6||||0.2778|TWO_SIDED|90.0|-6.8|23.9|||Chan and Zhang method|||Week 8||23.9|-6.8|0.2778
72586819|NCT03850483|144705229|SUPERIORITY||Risk Difference (RD)|2.1||||0.4571|TWO_SIDED|90.0|-14.5|21.0|||Chan and Zhang method|||Week 8||21.0|-14.5|0.4571
72586820|NCT03850483|144705229|SUPERIORITY||Risk Difference (RD)|-0.1||||0.4741|TWO_SIDED|90.0|-15.3|16.7|||Chan and Zhang method|||Week 8||16.7|-15.3|0.4741
72586821|NCT03850483|144705229|SUPERIORITY||Risk Difference (RD)|0.4||||0.5153|TWO_SIDED|90.0|-14.8|16.7|||Chan and Zhang method|||Week 8||16.7|-14.8|0.5153
72586822|NCT03850483|144705229|SUPERIORITY||Risk Difference (RD)|-7.0||||0.8287|TWO_SIDED|90.0|-21.1|5.3|||Chan and Zhang method|||Week 10||5.3|-21.1|0.8287
72586823|NCT03850483|144705229|SUPERIORITY||Risk Difference (RD)|-2.3||||0.5675|TWO_SIDED|90.0|-17.8|14.2|||Chan and Zhang method|||Week 10||14.2|-17.8|0.5675
72586824|NCT03850483|144705229|SUPERIORITY||Risk Difference (RD)|6.9||||0.2648|TWO_SIDED|90.0|-9.8|23.2|||Chan and Zhang method|||Week 10||23.2|-9.8|0.2648
72586825|NCT03850483|144705229|SUPERIORITY||Risk Difference (RD)|3.9||||0.3792|TWO_SIDED|90.0|-11.8|20.8|||Chan and Zhang method|||Week 10||20.8|-11.8|0.3792
72586826|NCT03850483|144705229|SUPERIORITY||Risk Difference (RD)|2.7||||0.4438|TWO_SIDED|90.0|-16.3|23.1|||Chan and Zhang method|||Week 10||23.1|-16.3|0.4438
72586827|NCT03850483|144705229|SUPERIORITY||Risk Difference (RD)|-7.5||||0.7014|TWO_SIDED|90.0|-23.3|9.4|||Chan and Zhang method|||Week 10||9.4|-23.3|0.7014
72586828|NCT03850483|144705229|SUPERIORITY||Risk Difference (RD)|-2.8||||0.5841|TWO_SIDED|90.0|-19.7|15.0|||Chan and Zhang method|||Week 10||15.0|-19.7|0.5841
72586829|NCT03850483|144705229|SUPERIORITY||Risk Difference (RD)|0.0||||0.5|TWO_SIDED|90.0|-15.3|15.3|||Chan and Zhang method|||Week 12||15.3|-15.3|0.5000
72586830|NCT03850483|144705229|SUPERIORITY||Risk Difference (RD)|-2.7||||0.5834|TWO_SIDED|90.0|-17.5|12.3|||Chan and Zhang method|||Week 12||12.3|-17.5|0.5834
72586831|NCT03850483|144705229|SUPERIORITY||Risk Difference (RD)|10.3||||0.1534|TWO_SIDED|90.0|-6.4|27.2|||Chan and Zhang method|||Week 12||27.2|-6.4|0.1534
72586832|NCT03850483|144705229|SUPERIORITY||Risk Difference (RD)|7.5||||0.272|TWO_SIDED|90.0|-8.8|24.9|||Chan and Zhang method|||Week 12||24.9|-8.8|0.2720
72586833|NCT03850483|144705229|SUPERIORITY||Risk Difference (RD)|-8.1||||0.6815|TWO_SIDED|90.0|-25.1|10.4|||Chan and Zhang method|||Week 12||10.4|-25.1|0.6815
72586834|NCT03850483|144705229|SUPERIORITY||Risk Difference (RD)|3.5||||0.39|TWO_SIDED|90.0|-14.4|22.0|||Chan and Zhang method|||Week 12||22.0|-14.4|0.3900
72586835|NCT03850483|144705229|SUPERIORITY||Risk Difference (RD)|-2.7||||0.5865|TWO_SIDED|90.0|-20.0|15.9|||Chan and Zhang method|||Week 12||15.9|-20.0|0.5865
72586836|NCT03850483|144705229|SUPERIORITY||Risk Difference (RD)|4.2||||0.3087|TWO_SIDED|90.0|-8.2|18.9|||Chan and Zhang method|||Week 14||18.9|-8.2|0.3087
72586837|NCT03850483|144705229|SUPERIORITY||Risk Difference (RD)|5.2||||0.3137|TWO_SIDED|90.0|-8.2|20.9|||Chan and Zhang method|||Week 14||20.9|-8.2|0.3137
72586838|NCT03850483|144705229|SUPERIORITY||Risk Difference (RD)|18.0||||0.0245|TWO_SIDED|90.0|2.7|34.8|||Chan and Zhang method|||Week 14||34.8|2.7|0.0245
72586839|NCT03850483|144705229|SUPERIORITY||Risk Difference (RD)|10.8||||0.1119|TWO_SIDED|90.0|-3.0|26.0|||Chan and Zhang method|||Week 14||26.0|-3.0|0.1119
72586840|NCT03850483|144705229|SUPERIORITY||Risk Difference (RD)|2.7||||0.414|TWO_SIDED|90.0|-13.2|20.4|||Chan and Zhang method|||Week 14||20.4|-13.2|0.4140
72586841|NCT03850483|144705229|SUPERIORITY||Risk Difference (RD)|9.7||||0.2356|TWO_SIDED|90.0|-7.2|28.5|||Chan and Zhang method|||Week 14||28.5|-7.2|0.2356
72586842|NCT03850483|144705229|SUPERIORITY||Risk Difference (RD)|4.5||||0.3638|TWO_SIDED|90.0|-11.5|21.5|||Chan and Zhang method|||Week 14||21.5|-11.5|0.3638
72586843|NCT03850483|144705229|SUPERIORITY||Risk Difference (RD)|7.7||||0.1613|TWO_SIDED|90.0|-5.2|22.9|||Chan and Zhang method|||Week 16||22.9|-5.2|0.1613
72586844|NCT03850483|144705229|SUPERIORITY||Risk Difference (RD)|13.9||||0.0557|TWO_SIDED|90.0|-0.5|31.4|||Chan and Zhang method|||Week 16||31.4|-0.5|0.0557
72586845|NCT03850483|144705229|SUPERIORITY||Risk Difference (RD)|21.6||||0.0114|TWO_SIDED|90.0|5.6|38.3|||Chan and Zhang method|||Week 16||38.3|5.6|0.0114
72586846|NCT03850483|144705229|SUPERIORITY||Risk Difference (RD)|11.9||||0.0753|TWO_SIDED|90.0|-1.8|28.1|||Chan and Zhang method|||Week 16||28.1|-1.8|0.0753
72586847|NCT03850483|144705229|SUPERIORITY||Risk Difference (RD)|-3.1||||0.5635|TWO_SIDED|90.0|-20.1|15.2|||Chan and Zhang method|||Week 16||15.2|-20.1|0.5635
72586848|NCT03850483|144705229|SUPERIORITY||Risk Difference (RD)|-3.6||||0.6201|TWO_SIDED|90.0|-20.3|14.5|||Chan and Zhang method|||Week 16||14.5|-20.3|0.6201
72586849|NCT03850483|144705229|SUPERIORITY||Risk Difference (RD)|-0.7||||0.4792|TWO_SIDED|90.0|-17.6|17.0|||Chan and Zhang method|||Week 16||17.0|-17.6|0.4792
72586850|NCT03850483|144705230|SUPERIORITY||LS mean difference|0.3|STANDARD_ERROR_OF_MEAN|0.31||0.8038|TWO_SIDED|90.0|-0.25|0.79|||MMRM|||Week 1: Mixed-effect model with repeated measures (MMRM) analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.79|-0.25|0.8038
72586851|NCT03850483|144705230|SUPERIORITY||LS mean difference|0.3|STANDARD_ERROR_OF_MEAN|0.31||0.8267|TWO_SIDED|90.0|-0.22|0.81|||MMRM|||Week 1: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.81|-0.22|0.8267
72586852|NCT03850483|144705230|SUPERIORITY||LS mean difference|0.1|STANDARD_ERROR_OF_MEAN|0.31||0.6039|TWO_SIDED|90.0|-0.43|0.6|||MMRM|||Week 1: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.60|-0.43|0.6039
72586853|NCT03850483|144705230|SUPERIORITY||LS mean difference|0.1|STANDARD_ERROR_OF_MEAN|0.31||0.6339|TWO_SIDED|90.0|-0.41|0.62|||MMRM|||Week 1: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.62|-0.41|0.6339
72586854|NCT03850483|144705230|SUPERIORITY||LS mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.3||0.2666|TWO_SIDED|90.0|-0.68|0.31|||MMRM|||Week 1: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.31|-0.68|0.2666
72586855|NCT03850483|144705230|SUPERIORITY||LS mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.29||0.2257|TWO_SIDED|90.0|-0.7|0.26|||MMRM|||Week 1: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.26|-0.70|0.2257
72586856|NCT03850483|144705230|SUPERIORITY||LS mean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.29||0.1306|TWO_SIDED|90.0|-0.81|0.15|||MMRM|||Week 1: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.15|-0.81|0.1306
72586857|NCT03850483|144705230|SUPERIORITY||LS mean difference|0.7|STANDARD_ERROR_OF_MEAN|0.37||0.9704|TWO_SIDED|90.0|0.09|1.31|||MMRM|||Week 2: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||1.31|0.09|0.9704
72586858|NCT03850483|144705230|SUPERIORITY||LS mean difference|0.5|STANDARD_ERROR_OF_MEAN|0.38||0.889|TWO_SIDED|90.0|-0.16|1.09|||MMRM|||Week 2: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||1.09|-0.16|0.8890
72586859|NCT03850483|144705230|SUPERIORITY||LS mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.37||0.4506|TWO_SIDED|90.0|-0.66|0.57|||MMRM|||Week 2: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.57|-0.66|0.4506
72586860|NCT03850483|144705230|SUPERIORITY||LS mean difference|0.1|STANDARD_ERROR_OF_MEAN|0.37||0.584|TWO_SIDED|90.0|-0.53|0.69|||MMRM|||Week 2: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.69|-0.53|0.5840
72586861|NCT03850483|144705230|SUPERIORITY||LS mean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.38||0.0769|TWO_SIDED|90.0|-1.17|0.08|||MMRM|||Week 2: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.08|-1.17|0.0769
72586862|NCT03850483|144705230|SUPERIORITY||LS mean difference|-0.8|STANDARD_ERROR_OF_MEAN|0.38||0.0242|TWO_SIDED|90.0|-1.39|-0.13|||MMRM|||Week 2: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||-0.13|-1.39|0.0242
72586863|NCT03850483|144705230|SUPERIORITY||LS mean difference|-0.9|STANDARD_ERROR_OF_MEAN|0.38||0.0127|TWO_SIDED|90.0|-1.49|-0.23|||MMRM|||Week 2: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||-0.23|-1.49|0.0127
72586864|NCT03850483|144705230|SUPERIORITY||LS mean difference|0.2|STANDARD_ERROR_OF_MEAN|0.44||0.6693|TWO_SIDED|90.0|-0.54|0.93|||MMRM|||Week 4: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.93|-0.54|0.6693
72586865|NCT03850483|144705230|SUPERIORITY||LS mean difference|0.2|STANDARD_ERROR_OF_MEAN|0.45||0.6742|TWO_SIDED|90.0|-0.55|0.96|||MMRM|||Week 4: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.96|-0.55|0.6742
72586866|NCT03850483|144705230|SUPERIORITY||LS mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.44||0.4486|TWO_SIDED|90.0|-0.79|0.67|||MMRM|||Week 4: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.67|-0.79|0.4486
72413974|NCT01934218|144336973|OTHER|Euflexxa would be considered superior to Gel-One if the difference in mean change from baseline in VAS pain score at week 26 was 5 mm or greater (on the 100mm VAS pain scale). If the difference in mean change values were within 5 mm, Gel-One would not be considered inferior to Euflexxa.||||||||||||||||A post-hoc non-inferiority comparison of the Gel-One mean change from baseline in VAS pain score at week 26 (Following 50-foot walk test) against the same assessment collected from subjects treated with Euflexxa in a separate study (PMID:19539353) was also performed.|Change from baseline (95% CI) for Euflexxa was -25.7 (-29.0, -22.4) and the difference between Euflexxa and Gel-One (95% CI) was -3.8 (-inf, -0.3).|||
72413975|NCT02232893|144336974|SUPERIORITY||||||>|0.05|||||||ANCOVA|||||||>0.05
72413976|NCT01587651|144336976|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was assessed using a 95% CI of the difference in mean PRU between ticagrelor and prasugrel (2 arms combined). Under the assumption of 0 difference in mean PRU between prasugrel 10 mg QD MD and ticagrelor 90 mg BID MD, a common SD of 60 PRU (based on previous DSI studies and published data), and a drop-out rate not exceeding 15%, a sample size of 105 allows for the 95% CI to stay within ± 45 PRU (non-inferiority margin) with a power of 90%.|Mean Difference (Final Values)|46.0|STANDARD_ERROR_OF_MEAN|10.66|||TWO_SIDED|95.0|24.9|67.2||||||ANCOVA model included treatment as a main effect and pre-randomization baseline PRU as a covariate. The combined prasugrel groups were modeled as a single treatment. If the upper limit of the CI for the mean difference was not greater than 45 PRU, then the PD response to prasugrel 10 mg QD MD was deemed noninferior to that achieved by ticagrelor 90 mg BID MD.||67.2|24.9|
72586867|NCT03850483|144705230|SUPERIORITY||LS mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.44||0.3219|TWO_SIDED|90.0|-0.93|0.53|||MMRM|||Week 4: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.53|-0.93|0.3219
72586868|NCT03850483|144705230|SUPERIORITY||LS mean difference|-1.3|STANDARD_ERROR_OF_MEAN|0.55||0.0096|TWO_SIDED|90.0|-2.21|-0.39|||MMRM|||Week 4: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||-0.39|-2.21|0.0096
72586869|NCT03850483|144705230|SUPERIORITY||LS mean difference|-0.7|STANDARD_ERROR_OF_MEAN|0.54||0.0862|TWO_SIDED|90.0|-1.64|0.15|||MMRM|||Week 4: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.15|-1.64|0.0862
72586870|NCT03850483|144705230|SUPERIORITY||LS mean difference|-1.3|STANDARD_ERROR_OF_MEAN|0.54||0.0111|TWO_SIDED|90.0|-2.15|-0.36|||MMRM|||Week 4: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||-0.36|-2.15|0.0111
72586871|NCT03850483|144705230|SUPERIORITY||LS mean difference|0.1|STANDARD_ERROR_OF_MEAN|0.5||0.6107|TWO_SIDED|90.0|-0.68|0.97|||MMRM|||Week 6: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.97|-0.68|0.6107
72586872|NCT03850483|144705230|SUPERIORITY||LS mean difference|0.3|STANDARD_ERROR_OF_MEAN|0.51||0.724|TWO_SIDED|90.0|-0.54|1.15|||MMRM|||Week 6: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||1.15|-0.54|0.7240
72586873|NCT03850483|144705230|SUPERIORITY||LS mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.5||0.43|TWO_SIDED|90.0|-0.91|0.74|||MMRM|||Week 6: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.74|-0.91|0.4300
72586874|NCT03850483|144705230|SUPERIORITY||LS mean difference|-0.8|STANDARD_ERROR_OF_MEAN|0.5||0.0501|TWO_SIDED|90.0|-1.66|0.0|||MMRM|||Week 6: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.00|-1.66|0.0501
72586875|NCT03850483|144705230|SUPERIORITY||LS mean difference|-1.3|STANDARD_ERROR_OF_MEAN|0.58||0.0157|TWO_SIDED|90.0|-2.23|-0.3|||MMRM|||Week 6: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||-0.30|-2.23|0.0157
72586876|NCT03850483|144705230|SUPERIORITY||LS mean difference|-0.9|STANDARD_ERROR_OF_MEAN|0.57||0.0645|TWO_SIDED|90.0|-1.83|0.07|||MMRM|||Week 6: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.07|-1.83|0.0645
72586877|NCT03850483|144705230|SUPERIORITY||LS mean difference|-0.9|STANDARD_ERROR_OF_MEAN|0.57||0.0621|TWO_SIDED|90.0|-1.84|0.06|||MMRM|||Week 6: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.06|-1.84|0.0621
72586878|NCT03850483|144705230|SUPERIORITY||LS mean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.55||0.2959|TWO_SIDED|90.0|-1.21|0.62|||MMRM|||Week 8: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.62|-1.21|0.2959
72586879|NCT03850483|144705230|SUPERIORITY||LS mean difference|0.7|STANDARD_ERROR_OF_MEAN|0.57||0.9043|TWO_SIDED|90.0|-0.19|1.69|||MMRM|||Week 8: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||1.69|-0.19|0.9043
72586880|NCT03850483|144705230|SUPERIORITY||LS mean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.55||0.2014|TWO_SIDED|90.0|-1.38|0.45|||MMRM|||Week 8: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.45|-1.38|0.2014
72586881|NCT03850483|144705230|SUPERIORITY||LS mean difference|-0.7|STANDARD_ERROR_OF_MEAN|0.56||0.0948|TWO_SIDED|90.0|-1.66|0.19|||MMRM|||Week 8: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.19|-1.66|0.0948
72586882|NCT03850483|144705230|SUPERIORITY||LS mean difference|-1.1|STANDARD_ERROR_OF_MEAN|0.65||0.0416|TWO_SIDED|90.0|-2.21|-0.06|||MMRM|||Week 8: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||-0.06|-2.21|0.0416
72413977|NCT01660763|144337028|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|87.59|STANDARD_ERROR_OF_MEAN|10.88|<|0.001|TWO_SIDED|95.0|66.2|108.98|||ANCOVA|||||108.98|66.20|<0.001
72413978|NCT03325712|144337030|OTHER||Slope|0.8188|STANDARD_ERROR_OF_MEAN|0.0725|||TWO_SIDED|90.0|0.6966|0.941|||||Based on the estimate for slope parameter (β), a 2-sided 90% CI for the slope was computed. Perfect dose proportionality would correspond to a slope of 1. Standard error of mean is standard error of slope.|The basic model for the investigation of dose proportionality is a power model that describes the functional relationship between the dose and PK endpoints. Statistical hypotheses were not tested in a confirmatory sense.||0.9410|0.6966|
72586883|NCT03850483|144705230|SUPERIORITY||LS mean difference|-1.1|STANDARD_ERROR_OF_MEAN|0.64||0.0454|TWO_SIDED|90.0|-2.14|-0.03|||MMRM|||Week 8: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||-0.03|-2.14|0.0454
72586884|NCT03850483|144705230|SUPERIORITY||LS mean difference|-1.3|STANDARD_ERROR_OF_MEAN|0.64||0.0256|TWO_SIDED|90.0|-2.31|-0.2|||MMRM|||Week 8: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||-0.20|-2.31|0.0256
72586885|NCT03850483|144705230|SUPERIORITY||LS mean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.57||0.2326|TWO_SIDED|90.0|-1.36|0.53|||MMRM|||Week 10: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.53|-1.36|0.2326
72586886|NCT03850483|144705230|SUPERIORITY||LS mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.59||0.5141|TWO_SIDED|90.0|-0.95|0.99|||MMRM|||Week 10: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.99|-0.95|0.5141
72586887|NCT03850483|144705230|SUPERIORITY||LS mean difference|-0.7|STANDARD_ERROR_OF_MEAN|0.57||0.1124|TWO_SIDED|90.0|-1.64|0.25|||MMRM|||Week 10: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.25|-1.64|0.1124
72586888|NCT03850483|144705230|SUPERIORITY||LS mean difference|-0.7|STANDARD_ERROR_OF_MEAN|0.58||0.0983|TWO_SIDED|90.0|-1.7|0.21|||MMRM|||Week 10: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.21|-1.70|0.0983
72586889|NCT03850483|144705230|SUPERIORITY||LS mean difference|-1.3|STANDARD_ERROR_OF_MEAN|0.72||0.0412|TWO_SIDED|90.0|-2.46|-0.07|||MMRM|||Week 10: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||-0.07|-2.46|0.0412
72586890|NCT03850483|144705230|SUPERIORITY||LS mean difference|-1.3|STANDARD_ERROR_OF_MEAN|0.71||0.034|TWO_SIDED|90.0|-2.47|-0.13|||MMRM|||Week 10: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||-0.13|-2.47|0.0340
72586891|NCT03850483|144705230|SUPERIORITY||LS mean difference|-1.3|STANDARD_ERROR_OF_MEAN|0.71||0.0379|TWO_SIDED|90.0|-2.44|-0.09|||MMRM|||Week 10: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||-0.09|-2.44|0.0379
72586892|NCT03850483|144705230|SUPERIORITY||LS mean difference|-0.8|STANDARD_ERROR_OF_MEAN|0.68||0.1291|TWO_SIDED|90.0|-1.91|0.36|||MMRM|||Week 12: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.36|-1.91|0.1291
72586893|NCT03850483|144705230|SUPERIORITY||LS mean difference|0.1|STANDARD_ERROR_OF_MEAN|0.7||0.5776|TWO_SIDED|90.0|-1.03|1.3|||MMRM|||Week 12: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||1.30|-1.03|0.5776
72586894|NCT03850483|144705230|SUPERIORITY||LS mean difference|-0.9|STANDARD_ERROR_OF_MEAN|0.69||0.1044|TWO_SIDED|90.0|-2.0|0.27|||MMRM|||Week 12: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.27|-2.00|0.1044
72586895|NCT03850483|144705230|SUPERIORITY||LS mean difference|-1.1|STANDARD_ERROR_OF_MEAN|0.69||0.0608|TWO_SIDED|90.0|-2.23|0.07|||MMRM|||Week 12: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.07|-2.23|0.0608
72586896|NCT03850483|144705230|SUPERIORITY||LS mean difference|-1.5|STANDARD_ERROR_OF_MEAN|0.8||0.0309|TWO_SIDED|90.0|-2.84|-0.18|||MMRM|||Week 12: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||-0.18|-2.84|0.0309
72586897|NCT03850483|144705230|SUPERIORITY||LS mean difference|-1.6|STANDARD_ERROR_OF_MEAN|0.78||0.0242|TWO_SIDED|90.0|-2.85|-0.26|||MMRM|||Week 12: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||-0.26|-2.85|0.0242
72586898|NCT03850483|144705230|SUPERIORITY||LS mean difference|-1.4|STANDARD_ERROR_OF_MEAN|0.78||0.0394|TWO_SIDED|90.0|-2.69|-0.09|||MMRM|||Week 12: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||-0.09|-2.69|0.0394
72586899|NCT03850483|144705232|SUPERIORITY||LS mean difference|2.6|STANDARD_ERROR_OF_MEAN|5.09||0.6917|TWO_SIDED|90.0|-5.86|10.97|||MMRM|||Week 1: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||10.97|-5.86|0.6917
72586900|NCT03850483|144705232|SUPERIORITY||LS mean difference|7.3|STANDARD_ERROR_OF_MEAN|5.07||0.9241|TWO_SIDED|90.0|-1.09|15.69|||MMRM|||Week 1: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||15.69|-1.09|0.9241
72586901|NCT03850483|144705232|SUPERIORITY||LS mean difference|5.1|STANDARD_ERROR_OF_MEAN|5.03||0.8443|TWO_SIDED|90.0|-3.21|13.42|||MMRM|||Week 1: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||13.42|-3.21|0.8443
72586902|NCT03850483|144705232|SUPERIORITY||LS mean difference|2.5|STANDARD_ERROR_OF_MEAN|5.04||0.6911|TWO_SIDED|90.0|-5.82|10.86|||MMRM|||Week 1: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||10.86|-5.82|0.6911
72586903|NCT03850483|144705232|SUPERIORITY||LS mean difference|-1.6|STANDARD_ERROR_OF_MEAN|4.79||0.3676|TWO_SIDED|90.0|-9.56|6.31|||MMRM|||Week 1: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||6.31|-9.56|0.3676
72586904|NCT03850483|144705232|SUPERIORITY||LS mean difference|-6.3|STANDARD_ERROR_OF_MEAN|4.72||0.0915|TWO_SIDED|90.0|-14.13|1.5|||MMRM|||Week 1: Week 1: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||1.50|-14.13|0.0915
72586905|NCT03850483|144705232|SUPERIORITY||LS mean difference|-6.2|STANDARD_ERROR_OF_MEAN|4.72||0.097|TWO_SIDED|90.0|-13.96|1.65|||MMRM|||Week 1: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||1.65|-13.96|0.0970
72586906|NCT03850483|144705232|SUPERIORITY||LS mean difference|9.2|STANDARD_ERROR_OF_MEAN|5.91||0.9389|TWO_SIDED|90.0|-0.59|18.97|||MMRM|||Week 2: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||18.97|-0.59|0.9389
72586907|NCT03850483|144705232|SUPERIORITY||LS mean difference|9.0|STANDARD_ERROR_OF_MEAN|6.07||0.9295|TWO_SIDED|90.0|-1.06|19.02|||MMRM|||Week 2: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors||19.02|-1.06|0.9295
72586908|NCT03850483|144705232|SUPERIORITY||LS mean difference|3.7|STANDARD_ERROR_OF_MEAN|5.92||0.7308|TWO_SIDED|90.0|-6.15|13.45|||MMRM|||Week 2: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||13.45|-6.15|0.7308
72586909|NCT03850483|144705232|SUPERIORITY||LS mean difference|1.8|STANDARD_ERROR_OF_MEAN|5.94||0.6199|TWO_SIDED|90.0|-8.01|11.64|||MMRM|||Week 2: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||11.64|-8.01|0.6199
72586910|NCT03850483|144705232|SUPERIORITY||LS mean difference|-9.0|STANDARD_ERROR_OF_MEAN|6.09||0.0699|TWO_SIDED|90.0|-19.13|1.04|||MMRM|||Week 2: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||1.04|-19.13|0.0699
72586911|NCT03850483|144705232|SUPERIORITY||LS mean difference|-11.6|STANDARD_ERROR_OF_MEAN|6.14||0.03|TWO_SIDED|90.0|-21.79|-1.48|||MMRM|||Week 2: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||-1.48|-21.79|0.0300
72586912|NCT03850483|144705232|SUPERIORITY||LS mean difference|-13.1|STANDARD_ERROR_OF_MEAN|6.09||0.0168|TWO_SIDED|90.0|-23.15|-2.98|||MMRM|||Week 2: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||-2.98|-23.15|0.0168
72586913|NCT03850483|144705232|SUPERIORITY||LS mean difference|3.6|STANDARD_ERROR_OF_MEAN|6.61||0.7083|TWO_SIDED|90.0|-7.3|14.57|||MMRM|||Week 4: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||14.57|-7.30|0.7083
72586914|NCT03850483|144705232|SUPERIORITY||LS mean difference|8.5|STANDARD_ERROR_OF_MEAN|6.77||0.8955|TWO_SIDED|90.0|-2.66|19.75|||MMRM|||Week 4: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||19.75|-2.66|0.8955
72586915|NCT03850483|144705232|SUPERIORITY||LS mean difference|6.5|STANDARD_ERROR_OF_MEAN|6.56||0.8386|TWO_SIDED|90.0|-4.35|17.37|||MMRM|||Week 4: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||17.37|-4.35|0.8386
72586916|NCT03850483|144705232|SUPERIORITY||LS mean difference|-1.0|STANDARD_ERROR_OF_MEAN|6.58||0.4371|TWO_SIDED|90.0|-11.93|9.84|||MMRM|||Week 4: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||9.84|-11.93|0.4371
72586917|NCT03850483|144705232|SUPERIORITY||LS mean difference|-20.7|STANDARD_ERROR_OF_MEAN|8.91||0.0108|TWO_SIDED|90.0|-35.42|-5.92|||MMRM|||Week 4: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||-5.92|-35.42|0.0108
72586918|NCT03850483|144705232|SUPERIORITY||LS mean difference|-10.9|STANDARD_ERROR_OF_MEAN|8.75||0.1066|TWO_SIDED|90.0|-25.43|3.55|||MMRM|||Week 4: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||3.55|-25.43|0.1066
72586919|NCT03850483|144705232|SUPERIORITY||LS mean difference|-16.0|STANDARD_ERROR_OF_MEAN|8.76||0.0344|TWO_SIDED|90.0|-30.54|-1.55|||MMRM|||Week 4: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||-1.55|-30.54|0.0344
72586920|NCT03850483|144705232|SUPERIORITY||LS mean difference|3.4|STANDARD_ERROR_OF_MEAN|8.29||0.6594|TWO_SIDED|90.0|-10.3|17.13|||MMRM|||Week 6: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||17.13|-10.30|0.6594
72586921|NCT03850483|144705232|SUPERIORITY||LS mean difference|5.3|STANDARD_ERROR_OF_MEAN|8.52||0.7307|TWO_SIDED|90.0|-8.85|19.36|||MMRM|||Week 6: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||19.36|-8.85|0.7307
72586922|NCT03850483|144705232|SUPERIORITY||LS mean difference|1.9|STANDARD_ERROR_OF_MEAN|8.28||0.5914|TWO_SIDED|90.0|-11.78|15.61|||MMRM|||Week 6: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||15.61|-11.78|0.5914
72586923|NCT03850483|144705232|SUPERIORITY||LS mean difference|-12.3|STANDARD_ERROR_OF_MEAN|8.34||0.0709|TWO_SIDED|90.0|-26.13|1.49|||MMRM|||Week 6: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||1.49|-26.13|0.0709
72586924|NCT03850483|144705232|SUPERIORITY||LS mean difference|-18.8|STANDARD_ERROR_OF_MEAN|9.53||0.0253|TWO_SIDED|90.0|-34.55|-3.01|||MMRM|||Week 6: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||-3.01|-34.55|0.0253
72586925|NCT03850483|144705232|SUPERIORITY||LS mean difference|-13.4|STANDARD_ERROR_OF_MEAN|9.38||0.078|TWO_SIDED|90.0|-28.89|2.15|||MMRM|||Week 6: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||2.15|-28.89|0.0780
72586926|NCT03850483|144705232|SUPERIORITY||LS mean difference|-9.7|STANDARD_ERROR_OF_MEAN|9.36||0.1516|TWO_SIDED|90.0|-25.17|5.83|||MMRM|||Week 6: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||5.83|-25.17|0.1516
72586927|NCT03850483|144705232|SUPERIORITY||LS mean difference|-0.3|STANDARD_ERROR_OF_MEAN|9.14||0.4861|TWO_SIDED|90.0|-15.45|14.81|||MMRM|||Week 8: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||14.81|-15.45|0.4861
72586928|NCT03850483|144705232|SUPERIORITY||LS mean difference|11.0|STANDARD_ERROR_OF_MEAN|9.38||0.8795|TWO_SIDED|90.0|-4.48|26.55|||MMRM|||Week 8: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||26.55|-4.48|0.8795
72586929|NCT03850483|144705232|SUPERIORITY||LS mean difference|-5.1|STANDARD_ERROR_OF_MEAN|9.11||0.2867|TWO_SIDED|90.0|-20.22|9.94|||MMRM|||Week 8: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||9.94|-20.22|0.2867
72586930|NCT03850483|144705232|SUPERIORITY||LS mean difference|-10.6|STANDARD_ERROR_OF_MEAN|9.23||0.1267|TWO_SIDED|90.0|-25.86|4.69|||MMRM|||Week 8: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||4.69|-25.86|0.1267
72586931|NCT03850483|144705232|SUPERIORITY||LS mean difference|-17.1|STANDARD_ERROR_OF_MEAN|10.49||0.0526|TWO_SIDED|90.0|-34.48|0.26|||MMRM|||Week 8: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.26|-34.48|0.0526
72586932|NCT03850483|144705232|SUPERIORITY||LS mean difference|-14.3|STANDARD_ERROR_OF_MEAN|10.25||0.0827|TWO_SIDED|90.0|-31.26|2.68|||MMRM|||Week 8: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||2.68|-31.26|0.0827
72586933|NCT03850483|144705232|SUPERIORITY||LS mean difference|-16.1|STANDARD_ERROR_OF_MEAN|10.26||0.0592|TWO_SIDED|90.0|-33.12|0.86|||MMRM|||Week 8: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.86|-33.12|0.0592
72586934|NCT03850483|144705232|SUPERIORITY||LS mean difference|-0.8|STANDARD_ERROR_OF_MEAN|9.03||0.4657|TWO_SIDED|90.0|-15.72|14.16|||MMRM|||Week 10: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||14.16|-15.72|0.4657
72586935|NCT03850483|144705232|SUPERIORITY||LS mean difference|3.9|STANDARD_ERROR_OF_MEAN|9.3||0.6612|TWO_SIDED|90.0|-11.52|19.26|||MMRM|||Week 10: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||19.26|-11.52|0.6612
72586936|NCT03850483|144705232|SUPERIORITY||LS mean difference|-8.5|STANDARD_ERROR_OF_MEAN|9.03||0.1749|TWO_SIDED|90.0|-23.42|6.48|||MMRM|||Week 10: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||6.48|-23.42|0.1749
72586937|NCT03850483|144705232|SUPERIORITY||LS mean difference|-9.3|STANDARD_ERROR_OF_MEAN|9.12||0.1548|TWO_SIDED|90.0|-24.39|5.8|||MMRM|||Week 10: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||5.80|-24.39|0.1548
72586938|NCT03850483|144705232|SUPERIORITY||LS mean difference|-21.0|STANDARD_ERROR_OF_MEAN|11.89||0.04|TWO_SIDED|90.0|-40.67|-1.28|||MMRM|||Week 10: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||-1.28|-40.67|0.0400
72586939|NCT03850483|144705232|SUPERIORITY||LS mean difference|-22.6|STANDARD_ERROR_OF_MEAN|11.6||0.0267|TWO_SIDED|90.0|-41.82|-3.39|||MMRM|||Week 10: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||-3.39|-41.82|0.0267
72586940|NCT03850483|144705232|SUPERIORITY||LS mean difference|-22.2|STANDARD_ERROR_OF_MEAN|11.63||0.0295|TWO_SIDED|90.0|-41.42|-2.89|||MMRM|||Week 10: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||-2.89|-41.42|0.0295
72586941|NCT03850483|144705232|SUPERIORITY||LS mean difference|-9.1|STANDARD_ERROR_OF_MEAN|10.38||0.1903|TWO_SIDED|90.0|-26.3|8.05|||MMRM|||Week 12: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||8.05|-26.30|0.1903
72586942|NCT03850483|144705232|SUPERIORITY||LS mean difference|1.4|STANDARD_ERROR_OF_MEAN|10.65||0.553|TWO_SIDED|90.0|-16.21|19.06|||MMRM|||Week 12: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||19.06|-16.21|0.5530
72586943|NCT03850483|144705232|SUPERIORITY||LS mean difference|-13.8|STANDARD_ERROR_OF_MEAN|10.37||0.0933|TWO_SIDED|90.0|-30.92|3.4|||MMRM|||Week 12: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||3.40|-30.92|0.0933
72586944|NCT03850483|144705232|SUPERIORITY||LS mean difference|-19.0|STANDARD_ERROR_OF_MEAN|10.49||0.036|TWO_SIDED|90.0|-36.37|-1.65|||MMRM|||Week 12: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||-1.65|-36.37|0.0360
72586945|NCT03850483|144705232|SUPERIORITY||LS mean difference|-24.5|STANDARD_ERROR_OF_MEAN|13.46||0.0354|TWO_SIDED|90.0|-46.85|-2.23|||MMRM|||Week 12: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||-2.23|-46.85|0.0354
72586946|NCT03850483|144705232|SUPERIORITY||LS mean difference|-26.1|STANDARD_ERROR_OF_MEAN|13.07||0.0239|TWO_SIDED|90.0|-47.77|-4.46|||MMRM|||Week 12: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||-4.46|-47.77|0.0239
72586947|NCT03850483|144705232|SUPERIORITY||LS mean difference|-24.1|STANDARD_ERROR_OF_MEAN|13.11||0.0342|TWO_SIDED|90.0|-45.84|-2.38|||MMRM|||Week 12: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||-2.38|-45.84|0.0342
72586948|NCT03850483|144705234|SUPERIORITY||LS mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.43||0.3279|TWO_SIDED|90.0|-0.91|0.52|||MMRM|||Baseline: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||0.52|-0.91|0.3279
72586949|NCT03850483|144705234|SUPERIORITY||LS mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.44||0.3566|TWO_SIDED|90.0|-0.88|0.56|||MMRM|||Baseline: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||0.56|-0.88|0.3566
72586950|NCT03850483|144705234|SUPERIORITY||LS mean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.45||0.1165|TWO_SIDED|90.0|-1.29|0.21|||MMRM|||Baseline: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||0.21|-1.29|0.1165
72586951|NCT03850483|144705234|SUPERIORITY||LS mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.43||0.3633|TWO_SIDED|90.0|-0.85|0.55|||MMRM|||Baseline: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||0.55|-0.85|0.3633
72586952|NCT03850483|144705234|SUPERIORITY||LS mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.42||0.3766|TWO_SIDED|90.0|-0.83|0.56|||MMRM|||Baseline: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||0.56|-0.83|0.3766
72586953|NCT03850483|144705234|SUPERIORITY||LS mean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.43||0.1179|TWO_SIDED|90.0|-1.22|0.2|||MMRM|||Baseline: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||0.20|-1.22|0.1179
72586954|NCT03850483|144705234|SUPERIORITY||LS mean difference|0.5|STANDARD_ERROR_OF_MEAN|0.44||0.8647|TWO_SIDED|90.0|-0.24|1.2|||MMRM|||Baseline: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||1.20|-0.24|0.8647
72586955|NCT03850483|144705234|SUPERIORITY||LS mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.43||0.3294|TWO_SIDED|90.0|-0.9|0.52|||MMRM|||Week 1: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||0.52|-0.90|0.3294
72586956|NCT03850483|144705234|SUPERIORITY||LS mean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.44||0.1231|TWO_SIDED|90.0|-1.23|0.21|||MMRM|||Week 1: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||0.21|-1.23|0.1231
72586957|NCT03850483|144705234|SUPERIORITY||LS mean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.45||0.0878|TWO_SIDED|90.0|-1.37|0.13|||MMRM|||Week 1: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||0.13|-1.37|0.0878
72586958|NCT03850483|144705234|SUPERIORITY||LS mean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.43||0.1225|TWO_SIDED|90.0|-1.2|0.21|||MMRM|||Week 1: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||0.21|-1.20|0.1225
72586959|NCT03850483|144705234|SUPERIORITY||LS mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.43||0.3663|TWO_SIDED|90.0|-0.85|0.56|||MMRM|||Week 1: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||0.56|-0.85|0.3663
72586960|NCT03850483|144705234|SUPERIORITY||LS mean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.43||0.0929|TWO_SIDED|90.0|-1.27|0.14|||MMRM|||Week 1: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||0.14|-1.27|0.0929
72586961|NCT03850483|144705234|SUPERIORITY||LS mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.44||0.3111|TWO_SIDED|90.0|-0.95|0.51|||MMRM|||Week 1: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||0.51|-0.95|0.3111
72586962|NCT03850483|144705234|SUPERIORITY||LS mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.43||0.4745|TWO_SIDED|90.0|-0.74|0.69|||MMRM|||Week 2: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||0.69|-0.74|0.4745
72586963|NCT03850483|144705234|SUPERIORITY||LS mean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.44||0.2409|TWO_SIDED|90.0|-1.03|0.42|||MMRM|||Week 2: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||0.42|-1.03|0.2409
72586964|NCT03850483|144705234|SUPERIORITY||LS mean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.45||0.2018|TWO_SIDED|90.0|-1.13|0.37|||MMRM|||Week 2: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||0.37|-1.13|0.2018
72586965|NCT03850483|144705234|SUPERIORITY||LS mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.43||0.3925|TWO_SIDED|90.0|-0.83|0.59|||MMRM|||Week 2: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||0.59|-0.83|0.3925
72586966|NCT03850483|144705234|SUPERIORITY||LS mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.42||0.5348|TWO_SIDED|90.0|-0.66|0.73|||MMRM|||Week 2: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||0.73|-0.66|0.5348
72586967|NCT03850483|144705234|SUPERIORITY||LS mean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.43||0.0739|TWO_SIDED|90.0|-1.33|0.09|||MMRM|||Week 2: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||0.09|-1.33|0.0739
72586968|NCT03850483|144705234|SUPERIORITY||LS mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.44||0.4014|TWO_SIDED|90.0|-0.84|0.62|||MMRM|||Week 2: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||0.62|-0.84|0.4014
72586969|NCT03850483|144705234|SUPERIORITY||LS mean difference|0.2|STANDARD_ERROR_OF_MEAN|0.45||0.6588|TWO_SIDED|90.0|-0.56|0.93|||MMRM|||Week 4: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||0.93|-0.56|0.6588
72586970|NCT03850483|144705234|SUPERIORITY||LS mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.46||0.2997|TWO_SIDED|90.0|-1.0|0.52|||MMRM|||Week 4: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||0.52|-1.00|0.2997
72586971|NCT03850483|144705234|SUPERIORITY||LS mean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.47||0.2518|TWO_SIDED|90.0|-1.08|0.46|||MMRM|||Week 4:MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||0.46|-1.08|0.2518
72586972|NCT03850483|144705234|SUPERIORITY||LS mean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.44||0.2634|TWO_SIDED|90.0|-1.0|0.45|||MMRM|||Week 4: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||0.45|-1.00|0.2634
72586973|NCT03850483|144705234|SUPERIORITY||LS mean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.45||0.1999|TWO_SIDED|90.0|-1.11|0.36|||MMRM|||Week 4: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||0.36|-1.11|0.1999
72586974|NCT03850483|144705234|SUPERIORITY||LS mean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.44||0.1847|TWO_SIDED|90.0|-1.13|0.33|||MMRM|||Week 4: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||0.33|-1.13|0.1847
72586975|NCT03850483|144705234|SUPERIORITY||LS mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.46||0.4569|TWO_SIDED|90.0|-0.81|0.71|||MMRM|||Week 4: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||0.71|-0.81|0.4569
72586976|NCT03850483|144705234|SUPERIORITY||LS mean difference|0.5|STANDARD_ERROR_OF_MEAN|0.45||0.8536|TWO_SIDED|90.0|-0.27|1.22|||MMRM|||Week 6: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||1.22|-0.27|0.8536
72586977|NCT03850483|144705234|SUPERIORITY||LS mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.46||0.4812|TWO_SIDED|90.0|-0.79|0.74|||MMRM|||Week 6:MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||0.74|-0.79|0.4812
72586978|NCT03850483|144705234|SUPERIORITY||LS mean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.47||0.2276|TWO_SIDED|90.0|-1.13|0.42|||MMRM|||Week 6: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||0.42|-1.13|0.2276
72586979|NCT03850483|144705234|SUPERIORITY||LS mean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.45||0.0895|TWO_SIDED|90.0|-1.34|0.14|||MMRM|||Week 6: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||0.14|-1.34|0.0895
72586980|NCT03850483|144705234|SUPERIORITY||LS mean difference|-0.8|STANDARD_ERROR_OF_MEAN|0.47||0.0411|TWO_SIDED|90.0|-1.58|-0.04|||MMRM|||Week 6: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||-0.04|-1.58|0.0411
72586981|NCT03850483|144705234|SUPERIORITY||LS mean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.47||0.0928|TWO_SIDED|90.0|-1.4|0.15|||MMRM|||Week 6: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||0.15|-1.40|0.0928
72586982|NCT03850483|144705234|SUPERIORITY||LS mean difference|-0.7|STANDARD_ERROR_OF_MEAN|0.49||0.0799|TWO_SIDED|90.0|-1.48|0.12|||MMRM|||Week 6: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||0.12|-1.48|0.0799
72586983|NCT03850483|144705234|SUPERIORITY||LS mean difference|0.4|STANDARD_ERROR_OF_MEAN|0.46||0.7872|TWO_SIDED|90.0|-0.39|1.11|||MMRM|||Week 8: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||1.11|-0.39|0.7872
72586984|NCT03850483|144705234|SUPERIORITY||LS mean difference|0.2|STANDARD_ERROR_OF_MEAN|0.47||0.6294|TWO_SIDED|90.0|-0.61|0.92|||MMRM|||Week 8: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||0.92|-0.61|0.6294
72586985|NCT03850483|144705234|SUPERIORITY||LS mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.48||0.5174|TWO_SIDED|90.0|-0.76|0.8|||MMRM|||Week 8: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||0.80|-0.76|0.5174
72586986|NCT03850483|144705234|SUPERIORITY||LS mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.46||0.3136|TWO_SIDED|90.0|-0.98|0.53|||MMRM|||Week 8: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||0.53|-0.98|0.3136
72586987|NCT03850483|144705234|SUPERIORITY||LS mean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.48||0.102|TWO_SIDED|90.0|-1.42|0.18|||MMRM|||Week 8: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||0.18|-1.42|0.1020
72586988|NCT03850483|144705234|SUPERIORITY||LS mean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.47||0.1923|TWO_SIDED|90.0|-1.2|0.37|||MMRM|||Week 8: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||0.37|-1.20|0.1923
72586989|NCT03850483|144705234|SUPERIORITY||LS mean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.49||0.0997|TWO_SIDED|90.0|-1.44|0.18|||MMRM|||Week 8: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||0.18|-1.44|0.0997
72586990|NCT03850483|144705234|SUPERIORITY||LS mean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.47||0.2497|TWO_SIDED|90.0|-1.08|0.45|||MMRM|||Week 10: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||0.45|-1.08|0.2497
72586991|NCT03850483|144705234|SUPERIORITY||LS mean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.47||0.2568|TWO_SIDED|90.0|-1.08|0.47|||MMRM|||Week 10: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||0.47|-1.08|0.2568
72586992|NCT03850483|144705234|SUPERIORITY||LS mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.48||0.373|TWO_SIDED|90.0|-0.95|0.64|||MMRM|||Week 10: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||0.64|-0.95|0.3730
72586993|NCT03850483|144705234|SUPERIORITY||LS mean difference|-1.0|STANDARD_ERROR_OF_MEAN|0.46||0.0137|TWO_SIDED|90.0|-1.76|-0.26|||MMRM|||Week 10: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||-0.26|-1.76|0.0137
72586994|NCT03850483|144705234|SUPERIORITY||LS mean difference|-1.3|STANDARD_ERROR_OF_MEAN|0.49||0.0055|TWO_SIDED|90.0|-2.06|-0.44|||MMRM|||Week 10: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||-0.44|-2.06|0.0055
72586995|NCT03850483|144705234|SUPERIORITY||LS mean difference|-1.2|STANDARD_ERROR_OF_MEAN|0.48||0.0069|TWO_SIDED|90.0|-1.99|-0.4|||MMRM|||Week 10: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||-0.40|-1.99|0.0069
72413979|NCT03325712|144337031|OTHER||Slope|0.7708|STANDARD_ERROR_OF_MEAN|0.0747|||TWO_SIDED|90.0|0.6449|0.8967|||||Based on the estimate for slope parameter (β), a 2-sided 90% CI for the slope was computed. Perfect dose proportionality would correspond to a slope of 1. Standard error of mean is standard error of slope.|The basic model for the investigation of dose proportionality is a power model that describes the functional relationship between the dose and PK endpoints. Statistical hypotheses were not tested in a confirmatory sense.||0.8967|0.6449|
72413980|NCT03325712|144337032|OTHER||Slope|0.7167|STANDARD_ERROR_OF_MEAN|0.133|||TWO_SIDED|90.0|0.4922|0.9412|||||Based on the estimate for slope parameter (β), a 2-sided 90% CI for the slope was computed. Perfect dose proportionality would correspond to a slope of 1. Standard error of mean is standard error of slope.|The basic model for the investigation of dose proportionality is a power model that describes the functional relationship between the dose and PK endpoints. Statistical hypotheses were not tested in a confirmatory sense.||0.9412|0.4922|
72586996|NCT03850483|144705234|SUPERIORITY||LS mean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.51||0.1648|TWO_SIDED|90.0|-1.34|0.34|||MMRM|||Week 10: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||0.34|-1.34|0.1648
72413981|NCT03325712|144337033|OTHER||Slope|0.6825|STANDARD_ERROR_OF_MEAN|0.1344|||TWO_SIDED|90.0|0.4556|0.9094|||||Based on the estimate for slope parameter (β), a 2-sided 90% CI for the slope was computed. Perfect dose proportionality would correspond to a slope of 1. Standard error of mean is standard error of slope.|The basic model for the investigation of dose proportionality is a power model that describes the functional relationship between the dose and PK endpoints. Statistical hypotheses were not tested in a confirmatory sense.||0.9094|0.4556|
72586997|NCT03850483|144705234|SUPERIORITY||LS mean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.46||0.2931|TWO_SIDED|90.0|-1.02|0.51|||MMRM|||Week 12: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||0.51|-1.02|0.2931
72586998|NCT03850483|144705234|SUPERIORITY||LS mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.47||0.3047|TWO_SIDED|90.0|-1.01|0.53|||MMRM|||Week 12: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||0.53|-1.01|0.3047
72586999|NCT03850483|144705234|SUPERIORITY||LS mean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.48||0.1924|TWO_SIDED|90.0|-1.22|0.38|||MMRM|||Week 12: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||0.38|-1.22|0.1924
72587000|NCT03850483|144705234|SUPERIORITY||LS mean difference|-0.8|STANDARD_ERROR_OF_MEAN|0.46||0.0465|TWO_SIDED|90.0|-1.52|-0.02|||MMRM|||Week 12: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||-0.02|-1.52|0.0465
72587001|NCT03850483|144705234|SUPERIORITY||LS mean difference|-1.3|STANDARD_ERROR_OF_MEAN|0.49||0.0048|TWO_SIDED|90.0|-2.08|-0.47|||MMRM|||Week 12: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||-0.47|-2.08|0.0048
72587002|NCT03850483|144705234|SUPERIORITY||LS mean difference|-1.0|STANDARD_ERROR_OF_MEAN|0.48||0.0186|TWO_SIDED|90.0|-1.78|-0.21|||MMRM|||Week 12: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||-0.21|-1.78|0.0186
72587003|NCT03850483|144705234|SUPERIORITY||LS mean difference|-0.8|STANDARD_ERROR_OF_MEAN|0.51||0.0675|TWO_SIDED|90.0|-1.61|0.08|||MMRM|||Week 12: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||0.08|-1.61|0.0675
72587004|NCT03850483|144705236|SUPERIORITY||LS mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.33||0.3232|TWO_SIDED|90.0|-0.69|0.39|||MMRM|||Week 1: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.39|-0.69|0.3232
72587005|NCT03850483|144705236|SUPERIORITY||LS mean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.33||0.0736|TWO_SIDED|90.0|-1.03|0.07|||MMRM|||Week 1: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.07|-1.03|0.0736
72587006|NCT03850483|144705236|SUPERIORITY||LS mean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.35||0.0743|TWO_SIDED|90.0|-1.07|0.07|||MMRM|||Week 1: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.07|-1.07|0.0743
72587007|NCT03850483|144705236|SUPERIORITY||LS mean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.32||0.0641|TWO_SIDED|90.0|-1.03|0.04|||MMRM|||Week 1: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.04|-1.03|0.0641
72587008|NCT03850483|144705236|SUPERIORITY||LS mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.36||0.3887|TWO_SIDED|90.0|-0.71|0.5|||MMRM|||Week 1: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.50|-0.71|0.3887
72587009|NCT03850483|144705236|SUPERIORITY||LS mean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.37||0.0767|TWO_SIDED|90.0|-1.15|0.08|||MMRM|||Week 1: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.08|-1.15|0.0767
72587010|NCT03850483|144705236|SUPERIORITY||LS mean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.38||0.2529|TWO_SIDED|90.0|-0.89|0.38|||MMRM|||Week 1: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.38|-0.89|0.2529
72587011|NCT03850483|144705236|SUPERIORITY||LS mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.39||0.5304|TWO_SIDED|90.0|-0.61|0.67|||MMRM|||Week 2: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.67|-0.61|0.5304
72413982|NCT03325712|144337034|OTHER||Ratio (T/R)|102.81|STANDARD_DEVIATION|17.5|||TWO_SIDED|90.0|87.18|121.25||||Standard deviation is intra-individual geometric coefficient of variation (%).|The effect of BI 705564 on midazolam is estimated by the ratio of the geometric mean (T/R) and confidence interval (CI). CI is calculated based on the residual error from ANOVA.|"Placebo matching BI 705564. Relative bioavailability of midazolam is analyzed using analysis of variance (ANOVA) model on logarithmic scale including random effects for subjects and fixed effects for time point."||121.25|87.18|
72413983|NCT03325712|144337034|OTHER||Ratio (T/R)|93.06|STANDARD_DEVIATION|17.4|||TWO_SIDED|90.0|79.94|108.32||||Standard deviation is intra-individual geometric coefficient of variation (%).|The effect of BI 705564 on midazolam is estimated by the ratio of the geometric mean (T/R) and confidence interval (CI). CI is calculated based on the residual error from ANOVA.|"BI 705564 dose group 2. Relative bioavailability of midazolam is analyzed using analysis of variance (ANOVA) model on logarithmic scale including random effects for subjects and fixed effects for time point."||108.32|79.94|
72587012|NCT03850483|144705236|SUPERIORITY||LS mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.39||0.292|TWO_SIDED|90.0|-0.87|0.43|||MMRM|||Week 2: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.43|-0.87|0.2920
72587013|NCT03850483|144705236|SUPERIORITY||LS mean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.41||0.2593|TWO_SIDED|90.0|-0.7|0.57|||MMRM|||Week 2: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.57|-0.70|0.2593
72587014|NCT03850483|144705236|SUPERIORITY||LS mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.38||0.431|TWO_SIDED|90.0|-0.7|0.57|||MMRM|||Week 2: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.57|-0.70|0.4310
72587015|NCT03850483|144705236|SUPERIORITY||LS mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.39||0.5477|TWO_SIDED|90.0|-0.59|0.69|||MMRM|||Week 2: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.69|-0.59|0.5477
72587016|NCT03850483|144705236|SUPERIORITY||LS mean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.39||0.0696|TWO_SIDED|90.0|-1.24|0.07|||MMRM|||Week 2: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.07|-1.24|0.0696
72587017|NCT03850483|144705236|SUPERIORITY||LS mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.41||0.3583|TWO_SIDED|90.0|-0.82|0.53|||MMRM|||Week 2: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.53|-0.82|0.3583
72587018|NCT03850483|144705236|SUPERIORITY||LS mean difference|0.2|STANDARD_ERROR_OF_MEAN|0.47||0.6826|TWO_SIDED|90.0|-0.56|1.01|||MMRM|||Week 4: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||1.01|-0.56|0.6826
72587019|NCT03850483|144705236|SUPERIORITY||LS mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.48||0.457|TWO_SIDED|90.0|-0.84|0.74|||MMRM|||Week 4: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.74|-0.84|0.4570
72587020|NCT03850483|144705236|SUPERIORITY||LS mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.49||0.3265|TWO_SIDED|90.0|-1.03|0.59|||MMRM|||Week 4: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.59|-1.03|0.3265
72587021|NCT03850483|144705236|SUPERIORITY||LS mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.46||0.3039|TWO_SIDED|90.0|-1.0|0.53|||MMRM|||Week 4: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.53|-1.00|0.3039
72587022|NCT03850483|144705236|SUPERIORITY||LS mean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.5||0.2086|TWO_SIDED|90.0|-1.23|0.42|||MMRM|||Week 4: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.42|-1.23|0.2086
72587023|NCT03850483|144705236|SUPERIORITY||LS mean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.5||0.2172|TWO_SIDED|90.0|-1.22|0.44|||MMRM|||Week 4: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.44|-1.22|0.2172
72587024|NCT03850483|144705236|SUPERIORITY||LS mean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.52||0.2855|TWO_SIDED|90.0|-1.16|0.57|||MMRM|||Week 4: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.57|-1.16|0.2855
72587025|NCT03850483|144705236|SUPERIORITY||LS mean difference|0.5|STANDARD_ERROR_OF_MEAN|0.51||0.8372|TWO_SIDED|90.0|-0.34|1.36|||MMRM|||Week 6: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||1.36|-0.34|0.8372
72587026|NCT03850483|144705236|SUPERIORITY||LS mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.52||0.4792|TWO_SIDED|90.0|-0.89|0.84|||MMRM|||Week 6: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.84|-0.89|0.4792
72587027|NCT03850483|144705236|SUPERIORITY||LS mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.53||0.3331|TWO_SIDED|90.0|-1.12|0.65|||MMRM|||Week 6: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.65|-1.12|0.3331
72587028|NCT03850483|144705236|SUPERIORITY||LS mean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.51||0.108|TWO_SIDED|90.0|-1.47|0.21|||MMRM|||Week 6: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.21|-1.47|0.1080
72587029|NCT03850483|144705236|SUPERIORITY||LS mean difference|-0.8|STANDARD_ERROR_OF_MEAN|0.48||0.0455|TWO_SIDED|90.0|-1.61|-0.02|||MMRM|||Week 6: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||-0.02|-1.61|0.0455
72587030|NCT03850483|144705236|SUPERIORITY||LS mean difference|-0.7|STANDARD_ERROR_OF_MEAN|0.48||0.0761|TWO_SIDED|90.0|-1.49|0.1|||MMRM|||Week 6: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.10|-1.49|0.0761
72413984|NCT03325712|144337034|OTHER||Ratio (T/R)|109.82|STANDARD_DEVIATION|5.0|||TWO_SIDED|90.0|103.59|116.42||||Standard deviation is intra-individual geometric coefficient of variation (%).|The effect of BI 705564 on midazolam is estimated by the ratio of the geometric mean (T/R) and confidence interval (CI). CI is calculated based on the residual error from ANOVA.|"BI 705564 dose group 3. Relative bioavailability of midazolam is analyzed using analysis of variance (ANOVA) model on logarithmic scale including random effects for subjects and fixed effects for time point."||116.42|103.59|
72413985|NCT03325712|144337034|OTHER||Ratio ( T/R)|108.37|STANDARD_DEVIATION|17.4|||TWO_SIDED|90.0|92.0|127.66||||Standard deviation is intra-individual geometric coefficient of variation (%).|The effect of BI 705564 on midazolam is estimated by the ratio of the geometric mean (T/R) and confidence interval (CI). CI is calculated based on the residual error from ANOVA.|"BI 705564 dose group 5. Relative bioavailability of midazolam is analyzed using analysis of variance (ANOVA) model on logarithmic scale including random effects for subjects and fixed effects for time point."||127.66|92.00|
72587031|NCT03850483|144705236|SUPERIORITY||LS mean difference|-1.0|STANDARD_ERROR_OF_MEAN|0.5||0.0273|TWO_SIDED|90.0|-1.8|-0.14|||MMRM|||Week 6: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||-0.14|-1.80|0.0273
72587032|NCT03850483|144705236|SUPERIORITY||LS mean difference|0.3|STANDARD_ERROR_OF_MEAN|0.54||0.7214|TWO_SIDED|90.0|-0.57|1.2|||MMRM|||Week 8: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||1.20|-0.57|0.7214
72587033|NCT03850483|144705236|SUPERIORITY||LS mean difference|0.2|STANDARD_ERROR_OF_MEAN|0.55||0.6132|TWO_SIDED|90.0|-0.75|1.06|||MMRM|||Week 8: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||1.06|-0.75|0.6132
72587034|NCT03850483|144705236|SUPERIORITY||LS mean difference|0.1|STANDARD_ERROR_OF_MEAN|0.56||0.5704|TWO_SIDED|90.0|-0.83|1.02|||MMRM|||Week 8: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||1.02|-0.83|0.5704
72587035|NCT03850483|144705236|SUPERIORITY||LS mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.53||0.3449|TWO_SIDED|90.0|-1.1|0.67|||MMRM|||Week 8: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.67|-1.10|0.3449
72587036|NCT03850483|144705236|SUPERIORITY||LS mean difference|-1.0|STANDARD_ERROR_OF_MEAN|0.58||0.0493|TWO_SIDED|90.0|-1.94|0.0|||MMRM|||Week 8: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.00|-1.94|0.0493
72587037|NCT03850483|144705236|SUPERIORITY||LS mean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.57||0.149|TWO_SIDED|90.0|-1.55|0.35|||MMRM|||Week 8: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.35|-1.55|0.1490
72587038|NCT03850483|144705236|SUPERIORITY||LS mean difference|-1.0|STANDARD_ERROR_OF_MEAN|0.6||0.054|TWO_SIDED|90.0|-1.96|0.02|||MMRM|||Week 8: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.02|-1.96|0.0540
72587039|NCT03850483|144705236|SUPERIORITY||LS mean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.61||0.3119|TWO_SIDED|90.0|-1.32|0.71|||MMRM|||Week 10: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.71|-1.32|0.3119
72587040|NCT03850483|144705236|SUPERIORITY||LS mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.62||0.3947|TWO_SIDED|90.0|-1.2|0.86|||MMRM|||Week 10: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.86|-1.20|0.3947
72587041|NCT03850483|144705236|SUPERIORITY||LS mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.64||0.4205|TWO_SIDED|90.0|-1.18|0.93|||MMRM|||Week 10: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.93|-1.18|0.4205
72587042|NCT03850483|144705236|SUPERIORITY||LS mean difference|-1.0|STANDARD_ERROR_OF_MEAN|0.6||0.0472|TWO_SIDED|90.0|-2.02|-0.02|||MMRM|||Week 10: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||-0.02|-2.02|0.0472
72587043|NCT03850483|144705236|SUPERIORITY||LS mean difference|-1.6|STANDARD_ERROR_OF_MEAN|0.59||0.0044|TWO_SIDED|90.0|-2.55|-0.6|||MMRM|||Week 10: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||-0.60|-2.55|0.0044
72587044|NCT03850483|144705236|SUPERIORITY||LS mean difference|-1.4|STANDARD_ERROR_OF_MEAN|0.58||0.0098|TWO_SIDED|90.0|-2.32|-0.41|||MMRM|||Week 10: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||-0.41|-2.32|0.0098
72587045|NCT03850483|144705236|SUPERIORITY||LS mean difference|-0.7|STANDARD_ERROR_OF_MEAN|0.61||0.1285|TWO_SIDED|90.0|-1.71|0.32|||MMRM|||Week 10: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.32|-1.71|0.1285
72587046|NCT03850483|144705236|SUPERIORITY||LS mean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.6||0.3243|TWO_SIDED|90.0|-1.27|0.72|||MMRM|||Week 12: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.72|-1.27|0.3243
72587047|NCT03850483|144705236|SUPERIORITY||LS mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.61||0.3795|TWO_SIDED|90.0|-1.2|0.82|||MMRM|||Week 12: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.82|-1.20|0.3795
72587048|NCT03850483|144705236|SUPERIORITY||LS mean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.62||0.307|TWO_SIDED|90.0|-1.35|0.72|||MMRM|||Week 12: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.72|-1.35|0.3070
72587049|NCT03850483|144705236|SUPERIORITY||LS mean difference|-0.8|STANDARD_ERROR_OF_MEAN|0.59||0.1014|TWO_SIDED|90.0|-1.74|0.22|||MMRM|||Week 12: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.22|-1.74|0.1014
72587050|NCT03850483|144705236|SUPERIORITY||LS mean difference|-1.7|STANDARD_ERROR_OF_MEAN|0.62||0.0033|TWO_SIDED|90.0|-2.75|-0.69|||MMRM|||Week 12: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||-0.69|-2.75|0.0033
72587051|NCT03850483|144705236|SUPERIORITY||LS mean difference|-1.2|STANDARD_ERROR_OF_MEAN|0.6||0.028|TWO_SIDED|90.0|-2.18|-0.17|||MMRM|||Week 12: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||-0.17|-2.18|0.0280
72587052|NCT03850483|144705236|SUPERIORITY||LS mean difference|-0.9|STANDARD_ERROR_OF_MEAN|0.64||0.0781|TWO_SIDED|90.0|-1.98|0.15|||MMRM|||Week 12: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.15|-1.98|0.0781
72587053|NCT03850483|144705240|SUPERIORITY||Risk Difference (RD)|-0.1||||0.4216|TWO_SIDED|90.0|-9.4|9.1|||Chan and Zhang method|||Week 1||9.1|-9.4|0.4216
72587054|NCT03850483|144705240|SUPERIORITY||Risk Difference (RD)|-0.1||||0.4216|TWO_SIDED|90.0|-9.4|9.1|||Chan and Zhang method|||Week 1||9.1|-9.4|0.4216
72587055|NCT03850483|144705240|SUPERIORITY||Risk Difference (RD)|-2.8||||0.7362|TWO_SIDED|90.0|-12.5|5.0|||Chan and Zhang method|||Week 1||5.0|-12.5|0.7362
72587056|NCT03850483|144705240|SUPERIORITY||Risk Difference (RD)|-2.8||||0.7417|TWO_SIDED|90.0|-12.5|4.7|||Chan and Zhang method|||Week 1||4.7|-12.5|0.7417
72587057|NCT03850483|144705240|SUPERIORITY||Risk Difference (RD)|0.0||||0.5|TWO_SIDED|90.0|-5.9|8.0|||Chan and Zhang method|||Week 1||8.0|-5.9|0.5000
72587058|NCT03850483|144705240|SUPERIORITY||Risk Difference (RD)|5.7||||0.0714|TWO_SIDED|90.0|-0.8|16.9|||Chan and Zhang method|||Week 1||16.9|-0.8|0.0714
72587059|NCT03850483|144705240|SUPERIORITY||Risk Difference (RD)|5.3||||0.0813|TWO_SIDED|90.0|-1.1|15.7|||Chan and Zhang method|||Week 1||15.7|-1.1|0.0813
72587060|NCT03850483|144705240|SUPERIORITY||Risk Difference (RD)|-2.8||||0.7417|TWO_SIDED|90.0|-12.5|4.7|||Chan and Zhang method|||Week 2||4.7|-12.5|0.7417
72587061|NCT03850483|144705240|SUPERIORITY||Risk Difference (RD)|-2.8||||0.7417|TWO_SIDED|90.0|-12.5|4.7|||Chan and Zhang method|||Week 2||4.7|-12.5|0.7417
72587062|NCT03850483|144705240|SUPERIORITY||Risk Difference (RD)|0.0||||0.5|TWO_SIDED|90.0|-9.6|9.6|||Chan and Zhang method|||Week 2||9.6|-9.6|0.5000
72587063|NCT03850483|144705240|SUPERIORITY||Risk Difference (RD)|-0.1||||0.4216|TWO_SIDED|90.0|-9.4|9.1|||Chan and Zhang method|||Week 2||9.1|-9.4|0.4216
72587064|NCT03850483|144705240|SUPERIORITY||Risk Difference (RD)|-2.0||||0.6894|TWO_SIDED|90.0|-9.4|5.9|||Chan and Zhang method|||Week 2||5.9|-9.4|0.6894
72587065|NCT03850483|144705240|SUPERIORITY||Risk Difference (RD)|3.7||||0.2518|TWO_SIDED|90.0|-4.2|14.3|||Chan and Zhang method|||Week 2||14.3|-4.2|0.2518
72587066|NCT03850483|144705240|SUPERIORITY||Risk Difference (RD)|8.5||||0.0565|TWO_SIDED|90.0|-0.3|20.3|||Chan and Zhang method|||Week 2||20.3|-0.3|0.0565
72587067|NCT03850483|144705240|SUPERIORITY||Risk Difference (RD)|-0.2||||0.4446|TWO_SIDED|90.0|-11.0|11.0|||Chan and Zhang method|||Week 4||11.0|-11.0|0.4446
72587068|NCT03850483|144705240|SUPERIORITY||Risk Difference (RD)|-5.6||||0.9001|TWO_SIDED|90.0|-16.5|1.9|||Chan and Zhang method|||Week 4||1.9|-16.5|0.9001
72587069|NCT03850483|144705240|SUPERIORITY||Risk Difference (RD)|0.0||||0.5|TWO_SIDED|90.0|-11.0|11.0|||Chan and Zhang method|||Week 4||11.0|-11.0|0.5000
72587070|NCT03850483|144705240|SUPERIORITY||Risk Difference (RD)|-0.2||||0.4446|TWO_SIDED|90.0|-11.0|11.0|||Chan and Zhang method|||Week 4||11.0|-11.0|0.4446
72587071|NCT03850483|144705240|SUPERIORITY||Risk Difference (RD)|0.2||||0.5054|TWO_SIDED|90.0|-10.5|12.5|||Chan and Zhang method|||Week 4||12.5|-10.5|0.5054
72587072|NCT03850483|144705240|SUPERIORITY||Risk Difference (RD)|3.3||||0.3401|TWO_SIDED|90.0|-8.2|16.9|||Chan and Zhang method|||Week 4||16.9|-8.2|0.3401
72587073|NCT03850483|144705240|SUPERIORITY||Risk Difference (RD)|12.9||||0.0489|TWO_SIDED|90.0|0.1|27.5|||Chan and Zhang method|||Week 4||27.5|0.1|0.0489
72587074|NCT03850483|144705240|SUPERIORITY||Risk Difference (RD)|-2.9||||0.6349|TWO_SIDED|90.0|-14.8|8.4|||Chan and Zhang method|||Week 6||8.4|-14.8|0.6349
72587075|NCT03850483|144705240|SUPERIORITY||Risk Difference (RD)|-5.6||||0.8253|TWO_SIDED|90.0|-17.2|4.4|||Chan and Zhang method|||Week 6||4.4|-17.2|0.8253
72587076|NCT03850483|144705240|SUPERIORITY||Risk Difference (RD)|0.0||||0.5|TWO_SIDED|90.0|-12.5|12.5|||Chan and Zhang method|||Week 6||12.5|-12.5|0.5000
72587077|NCT03850483|144705240|SUPERIORITY||Risk Difference (RD)|5.2||||0.2709|TWO_SIDED|90.0|-8.3|19.1|||Chan and Zhang method|||Week 6||19.1|-8.3|0.2709
72587078|NCT03850483|144705240|SUPERIORITY||Risk Difference (RD)|0.2||||0.5054|TWO_SIDED|90.0|-10.5|12.5|||Chan and Zhang method|||Week 6||12.5|-10.5|0.5054
72587079|NCT03850483|144705240|SUPERIORITY||Risk Difference (RD)|-2.4||||0.6319|TWO_SIDED|90.0|-12.9|9.3|||Chan and Zhang method|||Week 6||9.3|-12.9|0.6319
72587080|NCT03850483|144705240|SUPERIORITY||Risk Difference (RD)|5.0||||0.3199|TWO_SIDED|90.0|-6.4|18.1|||Chan and Zhang method|||Week 6||18.1|-6.4|0.3199
72587081|NCT03850483|144705240|SUPERIORITY||Risk Difference (RD)|-5.7||||0.7306|TWO_SIDED|90.0|-19.1|6.1|||Chan and Zhang method|||Week 8||6.1|-19.1|0.7306
72587082|NCT03850483|144705240|SUPERIORITY||Risk Difference (RD)|-5.7||||0.7306|TWO_SIDED|90.0|-19.1|6.1|||Chan and Zhang method|||Week 8||6.1|-19.1|0.7306
72587083|NCT03850483|144705240|SUPERIORITY||Risk Difference (RD)|-8.3||||0.8808|TWO_SIDED|90.0|-20.6|2.7|||Chan and Zhang method|||Week 8||2.7|-20.6|0.8808
72587084|NCT03850483|144705240|SUPERIORITY||Risk Difference (RD)|-0.3||||0.4644|TWO_SIDED|90.0|-13.7|13.7|||Chan and Zhang method|||Week 8||13.7|-13.7|0.4644
72587085|NCT03850483|144705240|SUPERIORITY||Risk Difference (RD)|7.8||||0.1534|TWO_SIDED|90.0|-3.4|20.9|||Chan and Zhang method|||Week 8||20.9|-3.4|0.1534
72587086|NCT03850483|144705240|SUPERIORITY||Risk Difference (RD)|-0.4||||0.4867|TWO_SIDED|90.0|-10.0|11.4|||Chan and Zhang method|||Week 8||11.4|-10.0|0.4867
72587087|NCT03850483|144705240|SUPERIORITY||Risk Difference (RD)|12.3||||0.0435|TWO_SIDED|90.0|0.4|25.9|||Chan and Zhang method|||Week 8||25.9|0.4|0.0435
72587088|NCT03850483|144705240|SUPERIORITY||Risk Difference (RD)|-2.9||||0.6349|TWO_SIDED|90.0|-14.8|8.4|||Chan and Zhang method|||Week 10||8.4|-14.8|0.6349
72587089|NCT03850483|144705240|SUPERIORITY||Risk Difference (RD)|-0.2||||0.4565|TWO_SIDED|90.0|-12.6|12.5|||Chan and Zhang method|||Week 10||12.5|-12.6|0.4565
72587090|NCT03850483|144705240|SUPERIORITY||Risk Difference (RD)|0.0||||0.5|TWO_SIDED|90.0|-12.5|12.5|||Chan and Zhang method|||Week 10||12.5|-12.5|0.5000
72587091|NCT03850483|144705240|SUPERIORITY||Risk Difference (RD)|7.9||||0.1765|TWO_SIDED|90.0|-5.7|21.8|||Chan and Zhang method|||Week 10||21.8|-5.7|0.1765
72587092|NCT03850483|144705240|SUPERIORITY||Risk Difference (RD)|0.3||||0.5013|TWO_SIDED|90.0|-14.0|15.2|||Chan and Zhang method|||Week 10||15.2|-14.0|0.5013
72587093|NCT03850483|144705240|SUPERIORITY||Risk Difference (RD)|-7.8||||0.7969|TWO_SIDED|90.0|-20.7|5.9|||Chan and Zhang method|||Week 10||5.9|-20.7|0.7969
72587094|NCT03850483|144705240|SUPERIORITY||Risk Difference (RD)|-3.2||||0.6424|TWO_SIDED|90.0|-16.4|10.6|||Chan and Zhang method|||Week 10||10.6|-16.4|0.6424
72587095|NCT03850483|144705240|SUPERIORITY||Risk Difference (RD)|10.7||||0.062|TWO_SIDED|90.0|-0.7|23.6|||Chan and Zhang method|||Week 14||23.6|-0.7|0.0620
72587096|NCT03850483|144705240|SUPERIORITY||Risk Difference (RD)|2.8||||0.3402|TWO_SIDED|90.0|-7.0|13.4|||Chan and Zhang method|||Week 14||13.4|-7.0|0.3402
72587097|NCT03850483|144705240|SUPERIORITY||Risk Difference (RD)|5.8||||0.1743|TWO_SIDED|90.0|-4.5|17.6|||Chan and Zhang method|||Week 14||17.6|-4.5|0.1743
72587098|NCT03850483|144705240|SUPERIORITY||Risk Difference (RD)|10.7||||0.062|TWO_SIDED|90.0|-0.7|23.6|||Chan and Zhang method|||Week 14||23.6|-0.7|0.0620
72587099|NCT03850483|144705240|SUPERIORITY||Risk Difference (RD)|2.6||||0.3534|TWO_SIDED|90.0|-7.8|15.4|||Chan and Zhang method|||Week 14||15.4|-7.8|0.3534
72587100|NCT03850483|144705240|SUPERIORITY||Risk Difference (RD)|5.5||||0.2508|TWO_SIDED|90.0|-5.5|18.8|||Chan and Zhang method|||Week 14||18.8|-5.5|0.2508
72587101|NCT03850483|144705240|SUPERIORITY||Risk Difference (RD)|1.9||||0.4238|TWO_SIDED|90.0|-8.2|13.6|||Chan and Zhang method|||Week 14||13.6|-8.2|0.4238
72587102|NCT03850483|144705240|SUPERIORITY||Risk Difference (RD)|5.9||||0.2696|TWO_SIDED|90.0|-6.2|19.3|||Chan and Zhang method|||Week 16||19.3|-6.2|0.2696
72587103|NCT03850483|144705240|SUPERIORITY||Risk Difference (RD)|3.0||||0.3648|TWO_SIDED|90.0|-8.6|15.3|||Chan and Zhang method|||Week 16||15.3|-8.6|0.3648
72587104|NCT03850483|144705240|SUPERIORITY||Risk Difference (RD)|8.7||||0.1267|TWO_SIDED|90.0|-3.8|22.2|||Chan and Zhang method|||Week 16||22.2|-3.8|0.1267
72587105|NCT03850483|144705240|SUPERIORITY||Risk Difference (RD)|10.7||||0.0832|TWO_SIDED|90.0|-2.5|24.4|||Chan and Zhang method|||Week 16||24.4|-2.5|0.0832
72587106|NCT03850483|144705240|SUPERIORITY||Risk Difference (RD)|6.5||||0.2099|TWO_SIDED|90.0|-5.7|21.3|||Chan and Zhang method|||Week 16||21.3|-5.7|0.2099
72587107|NCT03850483|144705240|SUPERIORITY||Risk Difference (RD)|3.6||||0.3474|TWO_SIDED|90.0|-8.0|17.4|||Chan and Zhang method|||Week 16||17.4|-8.0|0.3474
72587108|NCT03850483|144705240|SUPERIORITY||Risk Difference (RD)|8.1||||0.2124|TWO_SIDED|90.0|-4.0|21.6|||Chan and Zhang method|||Week 16||21.6|-4.0|0.2124
72587109|NCT03850483|144705241|SUPERIORITY||Risk Difference (RD)|13.7||||0.0544|TWO_SIDED|90.0|-0.3|27.9|||Chan and Zhang method|||Week 1||27.9|-0.3|0.0544
72587110|NCT03850483|144705241|SUPERIORITY||Risk Difference (RD)|6.1||||0.2697|TWO_SIDED|90.0|-6.3|19.6|||Chan and Zhang method|||Week 1||19.6|-6.3|0.2697
72587111|NCT03850483|144705241|SUPERIORITY||Risk Difference (RD)|16.5||||0.0286|TWO_SIDED|90.0|2.0|31.0|||Chan and Zhang method|||Week 1||31.0|2.0|0.0286
72587112|NCT03850483|144705241|SUPERIORITY||Risk Difference (RD)|7.8||||0.1512|TWO_SIDED|90.0|-4.7|20.8|||Chan and Zhang method|||Week 1||20.8|-4.7|0.1512
72587113|NCT03850483|144705241|SUPERIORITY||Risk Difference (RD)|-7.7||||0.79|TWO_SIDED|90.0|-21.9|7.4|||Chan and Zhang method|||Week 1||7.4|-21.9|0.7900
72587114|NCT03850483|144705241|SUPERIORITY||Risk Difference (RD)|7.3||||0.3137|TWO_SIDED|90.0|-8.5|24.0|||Chan and Zhang method|||Week 1||24.0|-8.5|0.3137
72587115|NCT03850483|144705241|SUPERIORITY||Risk Difference (RD)|5.0||||0.3789|TWO_SIDED|90.0|-10.9|22.6|||Chan and Zhang method|||Week 1||22.6|-10.9|0.3789
72587116|NCT03850483|144705241|SUPERIORITY||Risk Difference (RD)|13.7||||0.0636|TWO_SIDED|90.0|-1.0|28.5|||Chan and Zhang method|||Week 2||28.5|-1.0|0.0636
72587117|NCT03850483|144705241|SUPERIORITY||Risk Difference (RD)|9.6||||0.1435|TWO_SIDED|90.0|-4.9|24.5|||Chan and Zhang method|||Week 2||24.5|-4.9|0.1435
72587118|NCT03850483|144705241|SUPERIORITY||Risk Difference (RD)|25.7||||0.0058|TWO_SIDED|90.0|8.9|42.4|||Chan and Zhang method|||Week 2||42.4|8.9|0.0058
72587119|NCT03850483|144705241|SUPERIORITY||Risk Difference (RD)|22.9||||0.0112|TWO_SIDED|90.0|6.5|38.9|||Chan and Zhang method|||Week 2||38.9|6.5|0.0112
72587120|NCT03850483|144705241|SUPERIORITY||Risk Difference (RD)|4.9||||0.3349|TWO_SIDED|90.0|-10.8|21.3|||Chan and Zhang method|||Week 2||21.3|-10.8|0.3349
72587121|NCT03850483|144705241|SUPERIORITY||Risk Difference (RD)|10.6||||0.2065|TWO_SIDED|90.0|-6.1|27.7|||Chan and Zhang method|||Week 2||27.7|-6.1|0.2065
72587122|NCT03850483|144705241|SUPERIORITY||Risk Difference (RD)|11.4||||0.1871|TWO_SIDED|90.0|-5.6|29.1|||Chan and Zhang method|||Week 2||29.1|-5.6|0.1871
72587123|NCT03850483|144705241|SUPERIORITY||Risk Difference (RD)|13.4||||0.1245|TWO_SIDED|90.0|-4.9|31.4|||Chan and Zhang method|||Week 4||31.4|-4.9|0.1245
72587124|NCT03850483|144705241|SUPERIORITY||Risk Difference (RD)|14.0||||0.128|TWO_SIDED|90.0|-4.7|33.7|||Chan and Zhang method|||Week 4||33.7|-4.7|0.1280
72587125|NCT03850483|144705241|SUPERIORITY||Risk Difference (RD)|32.9||||0.003|TWO_SIDED|90.0|12.4|50.5|||Chan and Zhang method|||Week 4||50.5|12.4|0.0030
72587126|NCT03850483|144705241|SUPERIORITY||Risk Difference (RD)|22.6||||0.0235|TWO_SIDED|90.0|3.1|40.6|||Chan and Zhang method|||Week 4||40.6|3.1|0.0235
72587127|NCT03850483|144705241|SUPERIORITY||Risk Difference (RD)|4.9||||0.3728|TWO_SIDED|90.0|-13.6|24.1|||Chan and Zhang method|||Week 4||24.1|-13.6|0.3728
72587128|NCT03850483|144705241|SUPERIORITY||Risk Difference (RD)|25.5||||0.0153|TWO_SIDED|90.0|4.0|43.6|||Chan and Zhang method|||Week 4||43.6|4.0|0.0153
72587129|NCT03850483|144705241|SUPERIORITY||Risk Difference (RD)|9.4||||0.2543|TWO_SIDED|90.0|-8.8|27.8|||Chan and Zhang method|||Week 4||27.8|-8.8|0.2543
72587130|NCT03850483|144705241|SUPERIORITY||Risk Difference (RD)|7.9||||0.2785|TWO_SIDED|90.0|-10.2|26.4|||Chan and Zhang method|||Week 6||26.4|-10.2|0.2785
72587131|NCT03850483|144705241|SUPERIORITY||Risk Difference (RD)|13.3||||0.1434|TWO_SIDED|90.0|-7.4|33.7|||Chan and Zhang method|||Week 6||33.7|-7.4|0.1434
72587132|NCT03850483|144705241|SUPERIORITY||Risk Difference (RD)|36.1||||0.0015|TWO_SIDED|90.0|12.8|54.1|||Chan and Zhang method|||Week 6||54.1|12.8|0.0015
72587133|NCT03850483|144705241|SUPERIORITY||Risk Difference (RD)|24.1||||0.0242|TWO_SIDED|90.0|3.4|43.9|||Chan and Zhang method|||Week 6||43.9|3.4|0.0242
72587134|NCT03850483|144705241|SUPERIORITY||Risk Difference (RD)|35.1||||0.0037|TWO_SIDED|90.0|10.0|54.1|||Chan and Zhang method|||Week 6||54.1|10.0|0.0037
72587135|NCT03850483|144705241|SUPERIORITY||Risk Difference (RD)|16.6||||0.1037|TWO_SIDED|90.0|-4.9|36.7|||Chan and Zhang method|||Week 6||36.7|-4.9|0.1037
72587136|NCT03850483|144705241|SUPERIORITY||Risk Difference (RD)|1.8||||0.4607|TWO_SIDED|90.0|-17.7|22.5|||Chan and Zhang method|||Week 6||22.5|-17.7|0.4607
72587137|NCT03850483|144705241|SUPERIORITY||Risk Difference (RD)|12.2||||0.1725|TWO_SIDED|90.0|-8.0|31.9|||Chan and Zhang method|||Week 8||31.9|-8.0|0.1725
72587138|NCT03850483|144705241|SUPERIORITY||Risk Difference (RD)|22.8||||0.0451|TWO_SIDED|90.0|0.2|43.6|||Chan and Zhang method|||Week 8||43.6|0.2|0.0451
72587139|NCT03850483|144705241|SUPERIORITY||Risk Difference (RD)|44.4||||0.0003|TWO_SIDED|90.0|21.3|62.9|||Chan and Zhang method|||Week 8||62.9|21.3|0.0003
72587140|NCT03850483|144705241|SUPERIORITY||Risk Difference (RD)|26.7||||0.0239|TWO_SIDED|90.0|3.8|47.6|||Chan and Zhang method|||Week 8||47.6|3.8|0.0239
72587141|NCT03850483|144705241|SUPERIORITY||Risk Difference (RD)|20.8||||0.0643|TWO_SIDED|90.0|-2.1|41.2|||Chan and Zhang method|||Week 8||41.2|-2.1|0.0643
72587142|NCT03850483|144705241|SUPERIORITY||Risk Difference (RD)|-6.0||||0.6676|TWO_SIDED|90.0|-25.9|15.9|||Chan and Zhang method|||Week 8||15.9|-25.9|0.6676
72587143|NCT03850483|144705241|SUPERIORITY||Risk Difference (RD)|17.6||||0.0898|TWO_SIDED|90.0|-4.2|37.8|||Chan and Zhang method|||Week 8||37.8|-4.2|0.0898
72587144|NCT03850483|144705241|SUPERIORITY||Risk Difference (RD)|11.8||||0.2707|TWO_SIDED|90.0|-10.1|32.9|||Chan and Zhang method|||Week 10||32.9|-10.1|0.2707
72587145|NCT03850483|144705241|SUPERIORITY||Risk Difference (RD)|9.0||||0.2981|TWO_SIDED|90.0|-14.2|31.0|||Chan and Zhang method|||Week 10||31.0|-14.2|0.2981
72587146|NCT03850483|144705241|SUPERIORITY||Risk Difference (RD)|31.0||||0.011|TWO_SIDED|90.0|8.0|51.4|||Chan and Zhang method|||Week 10||51.4|8.0|0.0110
72587147|NCT03850483|144705241|SUPERIORITY||Risk Difference (RD)|33.3||||0.0083|TWO_SIDED|90.0|9.1|53.2|||Chan and Zhang method|||Week 10||53.2|9.1|0.0083
72587148|NCT03850483|144705241|SUPERIORITY||Risk Difference (RD)|4.8||||0.4217|TWO_SIDED|90.0|-18.3|27.5|||Chan and Zhang method|||Week 10||27.5|-18.3|0.4217
72587149|NCT03850483|144705241|SUPERIORITY||Risk Difference (RD)|1.3||||0.5152|TWO_SIDED|90.0|-20.8|23.2|||Chan and Zhang method|||Week 10||23.2|-20.8|0.5152
72587150|NCT03850483|144705241|SUPERIORITY||Risk Difference (RD)|-11.8||||0.7002|TWO_SIDED|90.0|-33.1|11.7|||Chan and Zhang method|||Week 10||11.7|-33.1|0.7002
72587151|NCT03850483|144705241|SUPERIORITY||Risk Difference (RD)|27.6||||0.0169|TWO_SIDED|90.0|5.2|47.9|||Chan and Zhang method|||Week 12||47.9|5.2|0.0169
72587152|NCT03850483|144705241|SUPERIORITY||Risk Difference (RD)|25.9||||0.0283|TWO_SIDED|90.0|3.2|46.2|||Chan and Zhang method|||Week 12||46.2|3.2|0.0283
72587153|NCT03850483|144705241|SUPERIORITY||Risk Difference (RD)|37.9||||0.002|TWO_SIDED|90.0|14.3|57.1|||Chan and Zhang method|||Week 12||57.1|14.3|0.0020
72587154|NCT03850483|144705241|SUPERIORITY||Risk Difference (RD)|31.4||||0.0095|TWO_SIDED|90.0|8.4|51.5|||Chan and Zhang method|||Week 12||51.5|8.4|0.0095
72587155|NCT03850483|144705241|SUPERIORITY||Risk Difference (RD)|21.0||||0.0798|TWO_SIDED|90.0|-2.7|42.6|||Chan and Zhang method|||Week 12||42.6|-2.7|0.0798
72587156|NCT03850483|144705241|SUPERIORITY||Risk Difference (RD)|10.9||||0.2848|TWO_SIDED|90.0|-11.3|31.8|||Chan and Zhang method|||Week 12||31.8|-11.3|0.2848
72587157|NCT03850483|144705241|SUPERIORITY||Risk Difference (RD)|0.5||||0.5062|TWO_SIDED|90.0|-21.1|23.1|||Chan and Zhang method|||Week 12||23.1|-21.1|0.5062
72587158|NCT03850483|144705241|SUPERIORITY||Risk Difference (RD)|36.9||||0.0012|TWO_SIDED|90.0|16.7|55.3|||Chan and Zhang method|||Week 14||55.3|16.7|0.0012
72587159|NCT03850483|144705241|SUPERIORITY||Risk Difference (RD)|38.7||||0.0007|TWO_SIDED|90.0|17.3|57.4|||Chan and Zhang method|||Week 14||57.4|17.3|0.0007
72587160|NCT03850483|144705241|SUPERIORITY||Risk Difference (RD)|47.0||||0.0001|TWO_SIDED|90.0|24.6|65.1|||Chan and Zhang method|||Week 14||65.1|24.6|0.0001
72587161|NCT03850483|144705241|SUPERIORITY||Risk Difference (RD)|29.9||||0.0039|TWO_SIDED|90.0|9.5|48.7|||Chan and Zhang method|||Week 14||48.7|9.5|0.0039
72587162|NCT03850483|144705241|SUPERIORITY||Risk Difference (RD)|4.5||||0.3895|TWO_SIDED|90.0|-17.5|26.5|||Chan and Zhang method|||Week 14||26.5|-17.5|0.3895
72587163|NCT03850483|144705241|SUPERIORITY||Risk Difference (RD)|10.1||||0.2793|TWO_SIDED|90.0|-11.8|31.8|||Chan and Zhang method|||Week 14||31.8|-11.8|0.2793
72587164|NCT03850483|144705241|SUPERIORITY||Risk Difference (RD)|-8.5||||0.7027|TWO_SIDED|90.0|-28.4|12.2|||Chan and Zhang method|||Week 14||12.2|-28.4|0.7027
72587165|NCT03850483|144705241|SUPERIORITY||Risk Difference (RD)|37.0||||0.0009|TWO_SIDED|90.0|15.4|55.2|||Chan and Zhang method|||Week 16||55.2|15.4|0.0009
72587166|NCT03850483|144705241|SUPERIORITY||Risk Difference (RD)|23.0||||0.0205|TWO_SIDED|90.0|4.1|43.2|||Chan and Zhang method|||Week 16||43.2|4.1|0.0205
72587167|NCT03850483|144705241|SUPERIORITY||Risk Difference (RD)|46.8||||0.0001|TWO_SIDED|90.0|24.6|65.7|||Chan and Zhang method|||Week 16||65.7|24.6|0.0001
72587168|NCT03850483|144705241|SUPERIORITY||Risk Difference (RD)|44.6||||0.0002|TWO_SIDED|90.0|21.5|62.9|||Chan and Zhang method|||Week 16||62.9|21.5|0.0002
72587169|NCT03850483|144705241|SUPERIORITY||Risk Difference (RD)|-18.5||||0.9209|TWO_SIDED|90.0|-38.3|3.2|||Chan and Zhang method|||Week 16||3.2|-38.3|0.9209
72413986|NCT03325712|144337034|OTHER||Ratio (T/R)|109.11|STANDARD_DEVIATION|17.6|||TWO_SIDED|90.0|92.43|128.79||||Standard deviation is intra-individual geometric coefficient of variation (%).|The effect of BI 705564 on midazolam is estimated by the ratio of the geometric mean (T/R) and confidence interval (CI). CI is calculated based on the residual error from ANOVA.|"BI 705564 dose group 4. Relative bioavailability of midazolam is analyzed using analysis of variance (ANOVA) model on logarithmic scale including random effects for subjects and fixed effects for time point."||128.79|92.43|
72413987|NCT03325712|144337035|OTHER||Ratio (T/R)|100.1|STANDARD_DEVIATION|18.7|||TWO_SIDED|90.0|83.99|119.31||||Standard deviation is intra-individual geometric coefficient of variation (%).|The effect of BI 705564 on midazolam is estimated by the ratio of the geometric mean (T/R) and confidence interval (CI). CI is calculated based on the residual error from ANOVA.|"Placebo matching BI 705564. Relative bioavailability of midazolam is analyzed using analysis of variance (ANOVA) model on logarithmic scale including random effects for subjects and fixed effects for time point."||119.31|83.99|
72413988|NCT03325712|144337035|OTHER||Ratio (T/R)|84.43|STANDARD_DEVIATION|16.5|||TWO_SIDED|90.0|72.29|98.62||||Standard deviation is intra-individual geometric coefficient of variation (%).|The effect of BI 705564 on midazolam is estimated by the ratio of the geometric mean (T/R) and confidence interval (CI). CI is calculated based on the residual error from ANOVA.|"BI 705564 dose group 2. Relative bioavailability of midazolam is analyzed using analysis of variance (ANOVA) model on logarithmic scale including random effects for subjects and fixed effects for time point."||98.62|72.29|
72413989|NCT03325712|144337035|OTHER||Ratio (T/R)|109.41|STANDARD_DEVIATION|13.1|||TWO_SIDED|90.0|94.34|126.88||||Standard deviation is intra-individual geometric coefficient of variation (%).|The effect of BI 705564 on midazolam is estimated by the ratio of the geometric mean (T/R) and confidence interval (CI). CI is calculated based on the residual error from ANOVA.|"BI 705564 dose group 3. Relative bioavailability of midazolam is analyzed using analysis of variance (ANOVA) model on logarithmic scale including random effects for subjects and fixed effects for time point."||126.88|94.34|
72587170|NCT03850483|144705241|SUPERIORITY||Risk Difference (RD)|-13.9||||0.793|TWO_SIDED|90.0|-34.4|8.7|||Chan and Zhang method|||Week 16||8.7|-34.4|0.7930
72587171|NCT03850483|144705241|SUPERIORITY||Risk Difference (RD)|-5.1||||0.6156|TWO_SIDED|90.0|-28.0|20.1|||Chan and Zhang method|||Week 16||20.1|-28.0|0.6156
72587172|NCT00652626|144705293|SUPERIORITY_OR_OTHER_LEGACY||Ratio (%) of Geometric Means|98.4|||||TWO_SIDED|90.0|64.0|151.3|||||Ratio of geometric means is calculated as Azacitidine 50 mg/m\^2 / Azacitidine 25 mg/m\^2 and expressed as a percentage.|Geometric means, ratio and 90% confidence interval (CI) of ratio of geometric means are from one way analysis of variance models on the nature log-transformed dose-normalized AUC0-t, obtained on Day 1. Azacitidine 25 mg/m\^2 is the reference group for comparisons||151.3|64.0|
72587173|NCT00652626|144705293|SUPERIORITY_OR_OTHER_LEGACY||Ratio (%) of Geometric Means|67.5|||||TWO_SIDED|90.0|44.7|101.8|||||Ratio of geometric means is calculated as Azacitidine 75 mg/m\^2 / Azacitidine 25 mg/m\^2 and expressed as a percentage.|Geometric means, ratio and 90% CI of ratio of geometric means are from one way analysis of variance models on the nature log-transformed dose-normalized AUC0-t, obtained on Day 1. Azacitidine 25 mg/m\^2 is the reference group for comparisons||101.8|44.7|
72587174|NCT00652626|144705293|SUPERIORITY_OR_OTHER_LEGACY||Ratio (%) of Geometric Means|82.7|||||TWO_SIDED|90.0|53.8|127.2|||||Ratio of geometric means is calculated as Azacitidine 100 mg/m\^2 / Azacitidine 25 mg/m\^2 and expressed as a percentage.|Geometric means, ratio and 90% CI of ratio of geometric means are from one way analysis of variance models on the nature log-transformed dose-normalized AUC0-t, obtained on Day 1. Azacitidine 25 mg/m\^2 is the reference group for comparisons||127.2|53.8|
72587175|NCT00652626|144705294|SUPERIORITY_OR_OTHER_LEGACY||Ratio (%) of Geometric Means|97.4|||||TWO_SIDED|90.0|63.8|148.8|||||Ratio of geometric mean is calculated as Azacitidine 50 mg/m\^2 / Azacitidine 25 mg/m\^2 and expressed as a percentage.|Geometric means, ratio and 90% CI of ratio of geometric means are from one way analysis of variance models on the nature log-transformed dose-normalized AUC0-inf, obtained on Day 1. Azacitidine 25 mg/m\^2 is the reference group for comparisons.||148.8|63.8|
72587176|NCT00652626|144705294|SUPERIORITY_OR_OTHER_LEGACY||Ratio (%) of Geometric Means|68.5|||||TWO_SIDED|90.0|45.7|102.7|||||Ratio of geometric mean is calculated as Azacitidine 75 mg/m\^2 / Azacitidine 25 mg/m\^2 and expressed as a percentage.|Geometric means, ratio and 90% CI of ratio of geometric means are from one way analysis of variance models on the nature log-transformed dose-normalized AUC0-inf, obtained on Day 1. Azacitidine 25 mg/m\^2 is the reference group for comparisons.||102.7|45.7|
72587177|NCT00652626|144705294|SUPERIORITY_OR_OTHER_LEGACY||Ratio (%) of Geometric Means|83.2|||||TWO_SIDED|90.0|54.5|127.1|||||Ratio of geometric mean is calculated as Azacitidine 100 mg/m\^2 / Azacitidine 25 mg/m\^2 and expressed as a percentage.|Geometric means, ratio and 90% CI of ratio of geometric means are from one way analysis of variance models on the nature log-transformed dose-normalized AUC0-inf, obtained on Day 1. Azacitidine 25 mg/m\^2 is the reference group for comparisons.||127.1|54.5|
72587178|NCT00652626|144705295|SUPERIORITY_OR_OTHER_LEGACY||Ratio (%) of Geometric Means|127.7|||||TWO_SIDED|90.0|66.3|245.7|||||Ratio of geometric means is calculated as Azacitidine 50 mg/m\^2 / Azacitidine 25 mg/m\^2 and expressed as a percentage.|Geometric means, ratio and 90% CI of ratio of geometric means are from one way analysis of variance models on the nature log-transformed dose-normalized Cmax, obtained on Day 1. Azacitidine 25 mg/m\^2 is the reference group for comparisons||245.7|66.3|
72587179|NCT00652626|144705295|SUPERIORITY_OR_OTHER_LEGACY||Ratio (%) of Geometric Means|84.7|||||TWO_SIDED|90.0|45.3|158.5|||||Ratio of geometric means is calculated as Azacitidine 75 mg/m\^2 / Azacitidine 25 mg/m\^2 and expressed as a percentage.|Geometric means, ratio and 90% CI of ratio of geometric means are from one way analysis of variance models on the nature log-transformed dose-normalized Cmax, obtained on Day 1. Azacitidine 25 mg/m\^2 is the reference group for comparisons||158.5|45.3|
72413990|NCT03325712|144337035|OTHER||Ratio (T/R)|95.44|STANDARD_DEVIATION|19.1|||TWO_SIDED|90.0|79.75|114.21||||Standard deviation is intra-individual geometric coefficient of variation (%).|The effect of BI 705564 on midazolam is estimated by the ratio of the geometric mean (T/R) and confidence interval (CI). CI is calculated based on the residual error from ANOVA.|"BI 705564 dose group 5. Relative bioavailability of midazolam is analyzed using analysis of variance (ANOVA) model on logarithmic scale including random effects for subjects and fixed effects for time point."||114.21|79.75|
72413991|NCT03325712|144337035|OTHER||Ratio (T/R)|90.04|STANDARD_DEVIATION|25.9|||TWO_SIDED|90.0|70.75|114.59||||Standard deviation is intra-individual geometric coefficient of variation (%).|The effect of BI 705564 on midazolam is estimated by the ratio of the geometric mean (T/R) and confidence interval (CI). CI is calculated based on the residual error from ANOVA.|"BI 705564 dose group 4. Relative bioavailability of midazolam is analyzed using analysis of variance (ANOVA) model on logarithmic scale including random effects for subjects and fixed effects for time point."||114.59|70.75|
72587180|NCT00652626|144705295|SUPERIORITY_OR_OTHER_LEGACY||Ratio (%) of Geometric Means|107.5|||||TWO_SIDED|90.0|55.9|207.0|||||Ratio of geometric means is calculated as Azacitidine 100 mg/m\^2 / Azacitidine 25 mg/m\^2 and expressed as a percentage.|Geometric means, ratio and 90% CI of ratio of geometric means are from one way analysis of variance models on the nature log-transformed dose-normalized Cmax, obtained on Day 1. Azacitidine 25 mg/m\^2 is the reference group for comparisons||207.0|55.9|
72587181|NCT00652626|144705298|SUPERIORITY_OR_OTHER_LEGACY||Ratio (%) of Geometric Means|101.1|||||TWO_SIDED|90.0|71.2|143.6|||||Ratio of geometric mean is calculated as Azacitidine 50 mg/m\^2 / Azacitidine 25 mg/m\^2 and expressed as a percentage.|Geometric means, ratio and 90% CI of ratio of geometric means are from one way analysis of variance model on the nature log-transformed CL/F obtained on Day 1. Azacitidine 25 mg/m\^2 is the reference group for comparisons.||143.6|71.2|
72587182|NCT00652626|144705298|SUPERIORITY_OR_OTHER_LEGACY||Ratio (%) of Geometric Means|144.9|||||TWO_SIDED|90.0|103.6|202.7|||||Ratio of geometric mean is calculated as Azacitidine 75 mg/m\^2 / Azacitidine 25 mg/m\^2 and expressed as a percentage.|Geometric means, ratio and 90% CI of ratio of geometric means are from one way analysis of variance model on the nature log-transformed CL/F obtained on Day 1. Azacitidine 25 mg/m\^2 is the reference group for comparisons.||202.7|103.6|
72587183|NCT00652626|144705298|SUPERIORITY_OR_OTHER_LEGACY||Ratio (%) of Geometric Means|101.4|||||TWO_SIDED|90.0|71.4|143.9|||||Ratio of geometric mean is calculated as Azacitidine 100 mg/m\^2 / Azacitidine 25 mg/m\^2 and expressed as a percentage.|Geometric means, ratio and 90% CI of ratio of geometric means are from one way analysis of variance model on the nature log-transformed CL/F obtained on Day 1. Azacitidine 25 mg/m\^2 is the reference group for comparisons.||143.9|71.4|
72587184|NCT00652626|144705301|SUPERIORITY_OR_OTHER_LEGACY||Ratio (%) of Geometric Means|169.3|||||TWO_SIDED|90.0|109.2|262.5|||||Ratio of geometric mean is calculated as Severe RI/Normal RF and expressed as a percentage.|"Comparison of AUC0-t after a single dose (Day 1) in participants with normal renal function and participants with severe renal impairment.~Geometric means, ratio and 90% CI of ratio of geometric means are from an analysis of variance model with renal function group (normal and severe), visit (Day 1 and Day 5), renal function group by visit interaction as fixed effect, and patient nested within renal function group as a random effect on the nature log-transformed pharmacokinetic parameters"||262.5|109.2|
72587185|NCT00652626|144705301|SUPERIORITY_OR_OTHER_LEGACY||Ratio (%) of Geometric Means|140.4|||||TWO_SIDED|90.0|90.6|217.7|||||Ratio of geometric mean is calculated as Severe RI/Normal RF and expressed as a percentage.|"Comparison of AUC0-t after multiple doses (Day 5) in participants with normal renal function and participants with severe renal impairment.~Geometric means, ratio and 90% CI of ratio of geometric means are from an analysis of variance model with renal function group (normal and severe), visit (Day 1 and Day 5), renal function group by visit interaction as fixed effect, and patient nested within renal function group as a random effect on the nature log-transformed pharmacokinetic parameters."||217.7|90.6|
72587186|NCT00652626|144705302|SUPERIORITY_OR_OTHER_LEGACY||Ratio (%) of Geometric Means|166.3|||||TWO_SIDED|90.0|108.6|254.6|||||Ratio of geometric mean is calculated as Severe RI/Normal RF and expressed as a percentage.|"Comparison of AUC0-inf after a single dose (Day 1) in participants with normal renal function and participants with severe renal impairment.~Geometric means, ratio and 90% CI of ratio of geometric means are from an analysis of variance model with renal function group (normal and severe), visit (Day 1 and Day 5), renal function group by visit interaction as fixed effect, and patient nested within renal function group as a random effect on the nature log-transformed pharmacokinetic parameters."||254.6|108.6|
72587187|NCT00652626|144705302|SUPERIORITY_OR_OTHER_LEGACY||Ratio (%) of Geometric Means|141.2|||||TWO_SIDED|90.0|92.2|216.2|||||Ratio of geometric mean is calculated as Severe RI/Normal RF and expressed as a percentage.|"Comparison of AUC0-inf after multiple doses (Day 5) in participants with normal renal function and participants with severe renal impairment.~Geometric means, ratio and 90% CI of ratio of geometric means are from an analysis of variance model with renal function group (normal and severe), visit (Day 1 and Day 5), renal function group by visit interaction as fixed effect, and patient nested within renal function group as a random effect on the nature log-transformed pharmacokinetic parameters."||216.2|92.2|
72587188|NCT00652626|144705303|SUPERIORITY_OR_OTHER_LEGACY||Ratio (%) of Geometric Means|141.7|||||TWO_SIDED|90.0|73.2|274.6|||||Ratio of geometric mean is calculated as Severe RI/Normal RF and expressed as a percentage.|"Comparison of Cmax after a single dose (Day 1) in participants with normal renal function and participants with severe renal impairment.~Geometric means, ratio and 90% CI of ratio of geometric means are from an analysis of variance model with renal function group (normal and severe), visit (Day 1 and Day 5), renal function group by visit interaction as fixed effect, and patient nested within renal function group as a random effect on the nature log-transformed pharmacokinetic parameters."||274.6|73.2|
72587189|NCT00652626|144705303|SUPERIORITY_OR_OTHER_LEGACY||Ratio (%) of Geometric Means|105.6|||||TWO_SIDED|90.0|54.5|204.6|||||Ratio of geometric mean is calculated as Severe RI/Normal RF and expressed as a percentage.|"Comparison of Cmax after multiple doses (Day 5) in participants with normal renal function and participants with severe renal impairment.~Geometric means, ratio and 90% CI of ratio of geometric means are from an analysis of variance model with renal function group (normal and severe), visit (Day 1 and Day 5), renal function group by visit interaction as fixed effect, and patient nested within renal function group as a random effect on the nature log-transformed pharmacokinetic parameters."||204.6|54.5|
72587190|NCT00652626|144705304|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|0.25||||0.1342|TWO_SIDED|90.0|0.0|0.52|||Wilcoxon (Mann-Whitney)||Median difference is Severe RI - Normal RF.|Comparison of Tmax after a single dose (Day 1) in participants with normal renal function and participants with severe renal impairment.||0.52|0|0.1342
72587191|NCT00652626|144705304|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|0.25||||0.1017|TWO_SIDED|90.0|0.0|0.5|||Wilcoxon (Mann-Whitney)||Median difference is Severe RI - Normal RF.|Comparison of Tmax after multiple doses (Day 5) in participants with normal renal function and participants with severe renal impairment.||0.50|0|0.1017
72587192|NCT02898597|144705315|SUPERIORITY||Odds Ratio (OR)|12.31|||<|0.05|TWO_SIDED|95.0|1.37|110.3|||Regression, Logistic|||||110.30|1.37|< 0.05
72587193|NCT02898597|144705315|SUPERIORITY||||||<|0.05|||||||Fisher Exact|||Fisher Exact test was performed, comparing the proportion of participants whose abstinence was verified with salivary cotinine test between the two arms, which was significant (p = 0.02).||||<0.05
72587194|NCT01234870|144705328|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||The MR images resulting from two different image acquisition techniques, including Non-Corrected Breath-Hold Shallow-Breathing and Motion-Corrected, were assessed independently by two radiologists (average of 7 years of experience in reading cardiac MRI) using the American Heart Association modified 16 segment model and were evaluated using a four point Likert scale (1 = poor, 2 = fair, 3 = good, and 4 = excellent) for image quality||||<0.001
72587195|NCT01637922|144705362|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability|Geometric mean ratio (%)|118.12|STANDARD_DEVIATION|15.4||0.1638|TWO_SIDED|90.0|107.06|130.32||p-value for ratio outside interval 80% to 125%|ANOVA|Log transformed endpoints were analyzed using an ANOVA model, including treatment as a fixed effect and subject as a random effect.|The standard deviation is actually the intra-individual geometric coefficient of variation|Methadone(MTD) + Faldaprevir(FDV) on Day 9 vs. Methadone(MTD) alone on Day 1||130.32|107.06|0.1638
72587196|NCT01637922|144705363|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability|Geometric mean ratio (%)|114.08|STANDARD_DEVIATION|13.2||0.0391|TWO_SIDED|90.0|104.812|124.164||p-value for ratio outside interval 80% to 125%|ANOVA|Log transformed endpoints were analyzed using an ANOVA model, including treatment as a fixed effect and subject as a random effect.|The standard deviation is actually the intra-individual geometric coefficient of variation|Methadone(MTD) + Faldaprevir(FDV) on Day 9 vs. Methadone(MTD) alone on Day 1||124.164|104.812|0.0391
72587197|NCT01637922|144705364|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability|Geometric mean ratio (%)|111.79|STANDARD_DEVIATION|18.7||0.0603|TWO_SIDED|90.0|99.243|125.922||p-value for ratio outside interval 80% to 125%|ANOVA|Log transformed endpoints were analyzed using an ANOVA model, including treatment as a fixed effect and subject as a random effect.|The standard deviation is actually the intra-individual geometric coefficient of variation|Methadone(MTD) + Faldaprevir(FDV) on Day 9 vs. Methadone(MTD) alone on Day 1||125.922|99.243|0.0603
72587198|NCT01637922|144705365|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability|Geometric mean ratio (%)|117.65|STANDARD_DEVIATION|15.0||0.1424|TWO_SIDED|90.0|106.89|129.5||p-value for ratio outside interval 80% to 125%|ANOVA|Log transformed endpoints were analyzed using an ANOVA model, including treatment as a fixed effect and subject as a random effect.|The standard deviation is actually the intra-individual geometric coefficient of variation|S-Methadone(MTD) + Faldaprevir(FDV) on Day 9 vs. S-Methadone(MTD) alone on Day 1||129.50|106.89|0.1424
72587199|NCT01637922|144705366|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability|Geometric mean ratio (%)|111.46|STANDARD_DEVIATION|16.3||0.0367|TWO_SIDED|90.0|100.42|123.715||p-value for ratio outside interval 80% to 125%|ANOVA|Log transformed endpoints were analyzed using an ANOVA model, including treatment as a fixed effect and subject as a random effect.|The standard deviation is actually the intra-individual geometric coefficient of variation|S-Methadone(MTD) + Faldaprevir(FDV) on Day 9 vs. S-Methadone(MTD) alone on Day 1||123.715|100.420|0.0367
72413992|NCT00952653|144337036|SUPERIORITY_OR_OTHER||ratio of adjusted geometric means|71.4|||||TWO_SIDED|90.0|65.08|78.33|||||Values have been back-transformed from the log scale.|DVS SR + Midazolam (test) versus Midazolam (reference). Based on the sample size, this study has at least 85% power overall to demonstrate the lack of an interaction \[that is, equivalence in both AUCinf and Cmax and both midazolam and 1-hydroxy midazolam\], where overall study power is to be based on the product of the individual powers of the parameters of interest.||78.33|65.08|
72413993|NCT00952653|144337037|SUPERIORITY_OR_OTHER||ratio of adjusted geometric means|86.08|||||TWO_SIDED|90.0|79.04|93.74|||||Values have been back-transformed from the log scale.|DVS SR + Midazolam (test) versus Midazolam (reference). Based on the sample size, this study has at least 85% power overall to demonstrate the lack of an interaction \[that is, equivalence in both AUCinf and Cmax and both midazolam and 1-hydroxy midazolam\], where overall study power is to be based on the product of the individual powers of the parameters of interest.||93.74|79.04|
72413994|NCT00952653|144337038|SUPERIORITY_OR_OTHER||ratio of adjusted geometric means|92.55|||||TWO_SIDED|90.0|87.43|97.97|||||Values have been back-transformed from the log scale.|DVS SR + Midazolam (test) versus Midazolam (reference). Based on the sample size, this study has at least 85% power overall to demonstrate the lack of an interaction \[that is, equivalence in both AUCinf and Cmax and both midazolam and 1-hydroxy midazolam\], where overall study power is to be based on the product of the individual powers of the parameters of interest.||97.97|87.43|
72413995|NCT00952653|144337039|SUPERIORITY_OR_OTHER||ratio of adjusted geometric means|101.17|||||TWO_SIDED|90.0|92.96|110.11|||||Values have been back-transformed from the log scale.|DVS SR + Midazolam (test) versus Midazolam (reference). Based on the sample size, this study has at least 85% power overall to demonstrate the lack of an interaction \[that is, equivalence in both AUCinf and Cmax and both midazolam and 1-hydroxy midazolam\], where overall study power is to be based on the product of the individual powers of the parameters of interest.||110.11|92.96|
72413996|NCT00952653|144337040|SUPERIORITY_OR_OTHER||ratio of adjusted geometric means|72.1|||||TWO_SIDED|90.0|66.04|78.72|||||Values have been back-transformed from the log scale.|DVS SR + Midazolam (test) versus Midazolam (reference)||78.72|66.04|
72587200|NCT01637922|144705367|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability|Geometric mean ratio (%)|111.52|STANDARD_DEVIATION|17.7||0.0488|TWO_SIDED|90.0|99.577|124.888||p-value for ratio outside interval 80% to 125%|ANOVA|Log transformed endpoints were analyzed using an ANOVA model, including treatment as a fixed effect and subject as a random effect.|The standard deviation is actually the intra-individual geometric coefficient of variation|S-Methadone(MTD) + Faldaprevir(FDV) on Day 9 vs. S-Methadone(MTD) alone on Day 1||124.888|99.577|0.0488
72587201|NCT01637922|144705368|SUPERIORITY_OR_OTHER||Pearson Correlation Coefficient|-0.01098|||||TWO_SIDED|95.0|-0.189801|0.16864||||||Pearson correlation of trough concentrations of R-methadone and OOWS||0.168640|-0.189801|
72587202|NCT01637922|144705368|SUPERIORITY_OR_OTHER||Pearson Correlation Coefficient|-0.10188|||||TWO_SIDED|95.0|-0.287471|0.092062||||||Pearson correlation of change from baseline for trough concentrations of R-methadone and OOWS||0.092062|-0.287471|
72587203|NCT01637922|144705368|SUPERIORITY_OR_OTHER||Pearson Correlation Coefficient|-0.03198|||||TWO_SIDED|95.0|-0.209893|0.148238||||||Pearson correlation of trough concentrations of S-methadone and OOWS||0.148238|-0.209893|
72587204|NCT01637922|144705368|SUPERIORITY_OR_OTHER||Pearson Correlation Coefficient|0.0026|||||TWO_SIDED|95.0|-0.189172|0.194156||||||Pearson correlation of change from baseline for trough concentrations of S-methadone and OOWS||0.194156|-0.189172|
72587205|NCT01637922|144705368|SUPERIORITY_OR_OTHER||Pearson Correlation Coefficient|-0.03364|||||TWO_SIDED|95.0|-0.214505|0.149733||||||Pearson correlation of trough concentrations of Buprenorphine and OOWS||0.149733|-0.214505|
72587206|NCT01637922|144705368|SUPERIORITY_OR_OTHER||Pearson Correlation Coefficient|-0.14703|||||TWO_SIDED|95.0|-0.404929|0.135425||||||Pearson correlation of change from baseline for trough concentrations of Buprenorphine and OOWS||0.135425|-0.404929|
72587207|NCT01637922|144705368|SUPERIORITY_OR_OTHER||Pearson Correlation Coefficient|-0.05431|||||TWO_SIDED|95.0|-0.240578|0.136305||||||Pearson correlation of trough concentrations of norbuprenorphine and OOWS||0.136305|-0.240578|
72587208|NCT01637922|144705368|SUPERIORITY_OR_OTHER||Pearson Correlation Coefficient|-0.09727|||||TWO_SIDED|95.0|-0.344024|0.163687||||||Pearson correlation of change from baseline for trough concentrations of norbuprenorphine and OOWS||0.163687|-0.344024|
72587209|NCT01637922|144705368|SUPERIORITY_OR_OTHER||Pearson Correlation Coefficient|0.36105|||||||||||||Confidence interval is not provided due to sparse data. There was only 1 patient for this analysis.|Pearson correlation of trough concentrations of naloxone and OOWS||||
72587210|NCT01637922|144705369|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability|Geometric mean ratio (%)|108.71|STANDARD_DEVIATION|36.1||0.1642|TWO_SIDED|90.0|85.14|138.8||p-value for ratio outside interval 80% to 125%|ANOVA|Log transformed endpoints were analyzed using an ANOVA model, including treatment as a fixed effect and subject as a random effect.|The standard deviation is actually the intra-individual geometric coefficient of variation|BUPRENORPHINE(BUP) + Faldaprevir(FDV) on Day 9 vs. BUPRENORPHINE(BUP) alone on Day 1||138.80|85.14|0.1642
72587211|NCT01637922|144705370|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability|Geometric mean ratio (%)|92.43|STANDARD_DEVIATION|33.7||0.142|TWO_SIDED|90.0|73.48|116.27||p-value for ratio outside interval 80% to 125%|ANOVA|Log transformed endpoints were analyzed using an ANOVA model, including treatment as a fixed effect and subject as a random effect.|The standard deviation is actually the intra-individual geometric coefficient of variation|BUPRENORPHINE(BUP) + Faldaprevir(FDV) on Day 9 vs. BUPRENORPHINE(BUP) alone on Day 1||116.27|73.48|0.1420
72587212|NCT01637922|144705371|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability|Geometric mean ratio (%)|108.36|STANDARD_DEVIATION|38.1||0.1915|TWO_SIDED|90.0|81.611|143.883||p-value for ratio outside interval 80% to 125%|ANOVA|Log transformed endpoints were analyzed using an ANOVA model, including treatment as a fixed effect and subject as a random effect.|The standard deviation is actually the intra-individual geometric coefficient of variation|BUPRENORPHINE(BUP) + Faldaprevir(FDV) on Day 9 vs. BUPRENORPHINE(BUP) alone on Day 1||143.883|81.611|0.1915
72587213|NCT01637922|144705372|SUPERIORITY_OR_OTHER||Pearson Correlation Coefficient|0.04783|||||TWO_SIDED|95.0|-0.13275|0.224946||||||Pearson correlation of trough concentrations of R-methadone and SOWS||0.224946|-0.132750|
72587214|NCT01637922|144705372|SUPERIORITY_OR_OTHER||Pearson Correlation Coefficient|-0.39865|||||TWO_SIDED|95.0|-0.547072|-0.222288||||||Pearson correlation of change from baseline for trough concentrations of R-methadone and SOWS||-0.222288|-0.547072|
72587215|NCT01637922|144705372|SUPERIORITY_OR_OTHER||Pearson Correlation Coefficient|0.11175|||||TWO_SIDED|95.0|-0.069336|0.284848||||||Pearson correlation of trough concentrations of S-methadone and SOWS||0.284848|-0.069336|
72587216|NCT01637922|144705372|SUPERIORITY_OR_OTHER||Pearson Correlation Coefficient|-0.16815|||||TWO_SIDED|95.0|-0.34787|0.025107||||||Pearson correlation of change from baseline for trough concentrations of S-methadone and SOWS||0.025107|-0.347870|
72587217|NCT01637922|144705372|SUPERIORITY_OR_OTHER||Pearson Correlation Coefficient|0.0126|||||TWO_SIDED|95.0|-0.17016|0.194417||||||Pearson correlation of trough concentrations of Buprenorphine and SOWS||0.194417|-0.170160|
72587218|NCT01637922|144705372|SUPERIORITY_OR_OTHER||Pearson Correlation Coefficient|0.02352|||||TWO_SIDED|95.0|-0.253932|0.29696||||||Pearson correlation of change from baseline for trough concentrations of Buprenorphine and SOWS||0.296960|-0.253932|
72587219|NCT01637922|144705372|SUPERIORITY_OR_OTHER||Pearson Correlation Coefficient|-0.05787|||||TWO_SIDED|95.0|-0.24392|0.132819||||||Pearson correlation of trough concentrations of norbuprenorphine and SOWS||0.132819|-0.243920|
72587220|NCT01637922|144705372|SUPERIORITY_OR_OTHER||Pearson Correlation Coefficient|0.04052|||||TWO_SIDED|95.0|-0.218159|0.293233||||||Pearson correlation of change from baseline for trough concentrations of norbuprenorphine and SOWS||0.293233|-0.218159|
72587221|NCT01637922|144705372|SUPERIORITY_OR_OTHER||Pearson Correlation Coefficient|0.92231|||||||||||||Confidence interval is not provided due to sparse data. There was only 1 patient for this analysis.|Pearson correlation of trough concentrations of naloxone and SOWS||||
72587222|NCT01637922|144705373|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability|Geometric mean ratio (%)|138.0|STANDARD_DEVIATION|50.7||0.6889|TWO_SIDED|90.0|97.2|195.92||p-value for ratio outside interval 80% to 125%|ANOVA|Log transformed endpoints were analyzed using an ANOVA model, including treatment as a fixed effect and subject as a random effect.|The standard deviation is actually the intra-individual geometric coefficient of variation|NORBUPRENORPHINE(BUP) + Faldaprevir(FDV) on Day 9 vs. NORBUPRENORPHINE(BUP) alone on Day 1||195.92|97.20|0.6889
72587223|NCT01637922|144705374|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability|Geometric mean ratio (%)|132.86|STANDARD_DEVIATION|51.1||0.6188|TWO_SIDED|90.0|93.32|189.16||p-value for ratio outside interval 80% to 125%|ANOVA|Log transformed endpoints were analyzed using an ANOVA model, including treatment as a fixed effect and subject as a random effect.|The standard deviation is actually the intra-individual geometric coefficient of variation|NORBUPRENORPHINE(BUP) + Faldaprevir(FDV) on Day 9 vs. NORBUPRENORPHINE(BUP) alone on Day 1||189.16|93.32|0.6188
72587224|NCT01637922|144705375|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability|Geometric mean ratio (%)|112.03|STANDARD_DEVIATION|52.5||0.3152|TWO_SIDED|90.0|74.85|167.67||p-value for ratio outside interval 80% to 125%|ANOVA|Log transformed endpoints were analyzed using an ANOVA model, including treatment as a fixed effect and subject as a random effect.|The standard deviation is actually the intra-individual geometric coefficient of variation|NORBUPRENORPHINE(BUP) + Faldaprevir(FDV) on Day 9 vs. NORBUPRENORPHINE(BUP) alone on Day 1||167.67|74.85|0.3152
72587225|NCT01637922|144705376|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability|Geometric mean ratio (%)|98.94|STANDARD_DEVIATION|19.6||0.0107|TWO_SIDED|90.0|85.81|114.076||p-value for ratio outside interval 80% to 125%|ANOVA|Log transformed endpoints were analyzed using an ANOVA model, including treatment as a fixed effect and subject as a random effect.|The standard deviation is actually the intra-individual geometric coefficient of variation|NALOXONE(BUP) + Faldaprevir(FDV) on Day 9 vs. NALOXONE(BUP) alone on Day 1||114.076|85.810|0.0107
72587226|NCT01637922|144705377|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability|Geometric mean ratio (%)|94.33|STANDARD_DEVIATION|27.6||0.0738|TWO_SIDED|90.0|78.017|114.054||p-value for ratio outside interval 80% to 125%|ANOVA|Log transformed endpoints were analyzed using an ANOVA model, including treatment as a fixed effect and subject as a random effect.|The standard deviation is actually the intra-individual geometric coefficient of variation|NALOXONE(BUP) + Faldaprevir(FDV) on Day 9 vs. NALOXONE(BUP) alone on Day 1||114.054|78.017|0.0738
72587227|NCT00638404|144705379|OTHER|correlation of anxiety, anticipated pain medication use and anticipated pain to 24 hour evoked pain measured|||||<|0.001|||||||Spearman Correlation|anxiety to evoked pain is 0.24 (P\<.001); anticipated pain to evoked pain is 0.33 (P\<.001); anticipated pain medication to evoked pain is 0.33(P\<.001).||||||<.001
72587228|NCT00638404|144705379|OTHER|correlation of anxiety to evoked pain at 24 hour|||||<|0.001|||||||Spearman Correlation|||||||<.001
72587229|NCT00638404|144705379|OTHER|correlation of anticipated pain medication 24 hour evoked pain measured|||||<|0.001|||||||Spearman Correlation|||||||<.001
72587230|NCT00638404|144705379|OTHER|correlation of anticipated pain to 24 hour evoked pain measured|||||<|0.001|||||||Spearman Correlation|||||||<.001
72587231|NCT00638404|144705380|OTHER||||||<|0.001|||||||Spearman Correlation|||preoperative questionnaire evaluating anticipated amount of pain medication potentially needed postoperatively; 0= none at all up to 100=as much as possible||||<.001
72587232|NCT00638404|144705381|OTHER||||||<|0.001|||||||Spearman Correlation|||||||<.001
72587233|NCT00638404|144705382|OTHER|Correlation of|||||<|0.001|||||||Spearman Correlation|||||||<.001
72587234|NCT02027545|144705383|SUPERIORITY|||||||0.491|||||||Regression, Logistic|||||||0.491
72587235|NCT02027545|144705384|SUPERIORITY|||||||0.049|||||||Regression, Logistic|||||||0.049
72587236|NCT00693498|144705387|OTHER||||||<|0.03||||||the reported value is for POD#1 assessment|Wald Wolfowitz|||||||<0.03
72587237|NCT00693498|144705387|OTHER|||||||0.29||||||for POD#2 assessment|Wald-Wolf|||||||0.29
72587238|NCT00302848|144705411|NON_INFERIORITY_OR_EQUIVALENCE|Sample size calculations for VTE risk showed that 50,000 patients should be sufficient to exclude a twofold risk.|Hazard Ratio (HR)|1.0|||<|0.05||95.0|0.6|1.8|||Regression, Cox|||Null hypothesis: HR ≥ 2 (VTE of DRSP vs. LNG)||1.8|0.6|<0.05
72587239|NCT02074358|144705446|SUPERIORITY_OR_OTHER||mixed effect model|425.3|||<|0.001|TWO_SIDED|95.0|219.8|630.7|||Mixed Models Analysis||Treatment B versus Treatment A|The ETP change from pre-PCC baseline was analyzed using a mixed effect model that included treatment, sequence, and period as main effects. A hierarchical analysis was conducted with comparisons beginning with the primary endpoint and continuing through secondary endpoints (ETP; TGA lag time; TGA time to peak; TGA peak; TGA velocity index; PT; INR; aPTT; AXA). If resulting p-value was \< 0.05, then the next comparison of interest was made until p\>0.05 at which point, comparisons ended.||630.7|219.8|<0.001
72587240|NCT02074358|144705446|SUPERIORITY_OR_OTHER||mixed effect model|90.6||||0.131|TWO_SIDED|95.0|-31.3|212.4||In the hierarchical analysis, no statistical inferences were drawn from the analysis results for any secondary endpoint since a non-significant treatment difference was observed for the primary endpoint.|Mixed Models Analysis||Treatment C versus Treatment A|ETP change from pre-PCC baseline was analyzed using mixed effect model, including treatment, sequence, and period as main effects. Hierarchical analysis was conducted with comparisons beginning with primary endpoint and continuing through secondary endpoints (ETP; TGA lag time; TGA time to peak; TGA peak; TGA velocity index; PT; INR; aPTT; AXA). If resulting p-value was \< 0.05, then the next comparison of interest was made until p\>0.05 at which point, comparisons ended.||212.4|-31.3|0.131
72587241|NCT02074358|144705447|SUPERIORITY_OR_OTHER||mixed effect model|-0.21||||0.389|TWO_SIDED|95.0|-0.73|0.3||In the hierarchical analysis, no statistical inferences were drawn from the analysis results for other secondary endpoints since a non-significant treatment difference was observed for this first secondary endpoint (TGA lag time).|Mixed Models Analysis||Treatment B versus Treatment A|TGA Lag Time. ETP change from pre-PCC baseline was analyzed using a mixed effect model that included treatment, sequence, and period as main effects. A hierarchical analysis was conducted with comparisons beginning with the primary endpoint and continuing through secondary endpoints (ETP; TGA lag time; TGA time to peak; TGA peak; TGA velocity index; PT; INR; aPTT; AXA). If resulting p-value was \< 0.05, then the next comparison of interest was made until p\>0.05 at which point, comparisons ended.||0.30|-0.73|0.389
72587242|NCT02074358|144705447|SUPERIORITY_OR_OTHER||mixed effect model|-0.16||||0.142|TWO_SIDED|95.0|-0.38|0.06||In the hierarchical analysis, no statistical inferences were drawn from the analysis results for this secondary endpoint since a non-significant treatment difference was observed for the primary endpoint.|Mixed Models Analysis||Treatment C versus Treatment A|Lag Time. ETP change from pre-PCC baseline was analyzed using mixed effect model, including treatment, sequence, and period as main effects. Hierarchical analysis was conducted with comparisons beginning with primary endpoint and continuing through secondary endpoints (ETP; TGA lag time; TGA time to peak; TGA peak; TGA velocity index; PT; INR; aPTT; AXA). If resulting p-value was \< 0.05, then the next comparison of interest was made until p\>0.05 at which point, comparisons ended.||0.06|-0.38|0.142
72587243|NCT02074358|144705447|SUPERIORITY_OR_OTHER||mixed effect model|1.35||||0.2|TWO_SIDED|95.0|-0.81|3.52||In the hierarchical analysis, no statistical inferences were drawn from the analysis results for this secondary endpoint since a non-significant treatment difference was observed for the first secondary endpoint (TGA lag time).|Mixed Models Analysis||Treatment B versus Treatment A|Time to Peak. ETP change from pre-PCC baseline was analyzed using a mixed effect model that included treatment, sequence, and period as main effects. A hierarchical analysis was conducted with comparisons beginning with the primary endpoint and continuing through secondary endpoints (ETP; TGA lag time; TGA time to peak; TGA peak; TGA velocity index; PT; INR; aPTT; AXA). If resulting p-value was \< 0.05, then the next comparison of interest was made until p\>0.05 at which point, comparisons ended.||3.52|-0.81|0.200
72587244|NCT02074358|144705447|SUPERIORITY_OR_OTHER||mixed effect model|4.62|||<|0.001|TWO_SIDED|95.0|2.8|6.44||In the hierarchical analysis, no statistical inferences were drawn from the analysis results for this secondary endpoint since a non-significant treatment difference was observed for the primary endpoint.|Mixed Models Analysis||Treatment C versus Treatment A|Time to Peak. ETP change from pre-PCC baseline was analyzed using mixed effect model, including treatment, sequence, and period as main effects. Hierarchical analysis was conducted with comparisons beginning with primary endpoint and continuing through secondary endpoints (ETP; TGA lag time; TGA time to peak; TGA peak; TGA velocity index; PT; INR; aPTT; AXA). If resulting p-value was \< 0.05, then the next comparison of interest was made until p\>0.05 at which point, comparisons ended.||6.44|2.80|<0.001
72587245|NCT02074358|144705448|SUPERIORITY_OR_OTHER||mixed effect model|21.1||||0.014|TWO_SIDED|95.0|4.9|37.2||In the hierarchical analysis, no statistical inferences were drawn from the analysis results for this secondary endpoint since a non-significant treatment difference was observed for the first secondary endpoint (TGA lag time).|Mixed Models Analysis||Treatment B versus Treatment A|The ETP change from pre-PCC baseline was analyzed using a mixed effect model that included treatment, sequence, and period as main effects. A hierarchical analysis was conducted with comparisons beginning with the primary endpoint and continuing through secondary endpoints (ETP; TGA lag time; TGA time to peak; TGA peak; TGA velocity index; PT; INR; aPTT; AXA). If resulting p-value was \< 0.05, then the next comparison of interest was made until p\>0.05 at which point, comparisons ended.||37.2|4.9|0.014
72413997|NCT00952653|144337043|SUPERIORITY_OR_OTHER||ratio of adjusted geometric means|87.39|||||TWO_SIDED|90.0|80.42|94.96|||||Values have been back-transformed from the log scale.|DVS SR + Midazolam (test) versus Midazolam (reference)||94.96|80.42|
72413998|NCT02265237|144337046|SUPERIORITY|97.5% CI was calculated using the Wilson score method; the lower confidence bound for the percentage of participants with sustained virologic response at 12 weeks after treatment must exceed 67% to achieve superiority. The predefined threshold of 67% was based on historical SVR rates for HCV genotype 4 (GT4)-infected subjects treated with pegIFN/RBV.|Percentage of Participants|100.0|||||TWO_SIDED|97.5|92.4|100.0|||||The confidence interval was calculated using the Wilson score method.|The overall 2-sided significance level of 0.05 was split between Part I (arms A and B) and Part II (arm C) using a Bonferroni corrected alpha level of 0.025 for each part. Additionally, a fixed sequence procedure for Part I was used to proceed through the primary efficacy comparisons in the following order: 1) test of superiority of arm B and 2) test of superiority of arm A. The primary outcome within Arm C was tested with a Bonferroni-corrected Type 1 error rate of 0.025 for superiority.||100.0|92.4|
72413999|NCT02265237|144337046|SUPERIORITY|97.5% confidence interval (CI) was calculated using the Wilson score method; the lower confidence bound for the percentage of participants with sustained virologic response at 12 weeks after treatment must exceed 67% to achieve superiority. The predefined threshold of 67% was based on historical SVR rates for HCV GT4-infected subjects treated with pegIFN/RBV.|Percentage of Participants|96.6|||||TWO_SIDED|97.5|86.7|99.2|||||The confidence interval was calculated using the Wilson score method.|The overall 2-sided significance level of 0.05 was split between Part I (arms A and B) and Part II (arm C) using a Bonferroni corrected alpha level of 0.025 for each part. Additionally, a fixed sequence procedure for Part I was used to proceed through the primary efficacy comparisons in the following order: 1) test of superiority of arm B and 2) test of superiority of arm A. The primary outcome within Arm C was tested with a Bonferroni-corrected Type 1 error rate of 0.025 for superiority.||99.2|86.7|
72587246|NCT02074358|144705448|SUPERIORITY_OR_OTHER||mixed effect model|-6.4||||0.076|TWO_SIDED|95.0|-13.5|0.8||In the hierarchical analysis, no statistical inferences were drawn from the analysis results for this secondary endpoint since a non-significant treatment difference was observed for the primary endpoint.|Mixed Models Analysis||Treatment C versus Treatment A|ETP change from pre-PCC baseline was analyzed using mixed effect model, including treatment, sequence, and period as main effects. Hierarchical analysis was conducted with comparisons beginning with primary endpoint and continuing through secondary endpoints (ETP; TGA lag time; TGA time to peak; TGA peak; TGA velocity index; PT; INR; aPTT; AXA). If resulting p-value was \< 0.05, then the next comparison of interest was made until p\>0.05 at which point, comparisons ended.||0.8|-13.5|0.076
72587247|NCT02074358|144705449|SUPERIORITY_OR_OTHER||mixed effect model|0.0||||0.996|TWO_SIDED|95.0|-5.6|5.6||In the hierarchical analysis, no statistical inferences were drawn from the analysis results for this secondary endpoint since a non-significant treatment difference was observed for the first secondary endpoint (TGA lag time).|Mixed Models Analysis||Treatment B versus Treatment A|The ETP change from pre-PCC baseline was analyzed using a mixed effect model that included treatment, sequence, and period as main effects. A hierarchical analysis was conducted with comparisons beginning with the primary endpoint and continuing through secondary endpoints (ETP; TGA lag time; TGA time to peak; TGA peak; TGA velocity index; PT; INR; aPTT; AXA). If resulting p-value was \< 0.05, then the next comparison of interest was made until p\>0.05 at which point, comparisons ended.||5.6|-5.6|0.996
72587248|NCT02074358|144705449|SUPERIORITY_OR_OTHER||mixed effect model|-6.5|||<|0.001|TWO_SIDED|95.0|-9.5|-3.6||In the hierarchical analysis, no statistical inferences were drawn from the analysis results for this secondary endpoint since a non-significant treatment difference was observed for the primary endpoint.|Mixed Models Analysis||Treatment C versus Treatment A|ETP change from pre-PCC baseline was analyzed using mixed effect model, including treatment, sequence, and period as main effects. Hierarchical analysis was conducted with comparisons beginning with primary endpoint and continuing through secondary endpoints (ETP; TGA lag time; TGA time to peak; TGA peak; TGA velocity index; PT; INR; aPTT; AXA). If resulting p-value was \< 0.05, then the next comparison of interest was made until p\>0.05 at which point, comparisons ended.||-3.6|-9.5|<0.001
72587249|NCT02074358|144705450|SUPERIORITY_OR_OTHER||mixed effect model|-1.64|||<|0.001|TWO_SIDED|95.0|-2.16|-1.12||In the hierarchical analysis, no statistical inferences were drawn from the analysis results for this secondary endpoint since a non-significant treatment difference was observed for the first secondary endpoint (TGA lag time).|Mixed Models Analysis||Treatment B versus Treatment A|PT (Neoplastin CI+). ETP change from pre-PCC baseline was analyzed using mixed effect model that included treatment, sequence, and period as main effects. Hierarchical analysis was conducted with comparisons beginning with primary endpoint and continuing through secondary endpoints (ETP; TGA lag time; TGA time to peak; TGA peak; TGA velocity index; PT; INR; aPTT; AXA). If resulting p-value was \< 0.05, then the next comparison of interest was made until p\>0.05 at which point, comparisons ended.||-1.12|-2.16|<0.001
72587250|NCT02074358|144705450|SUPERIORITY_OR_OTHER||mixed effect model|-1.47|||<|0.001|TWO_SIDED|95.0|-1.95|-0.99||In the hierarchical analysis, no statistical inferences were drawn from the analysis results for this secondary endpoint since a non-significant treatment difference was observed for the primary endpoint.|Mixed Models Analysis||Treatment C versus Treatment A|PT (Neoplastin CI+). ETP change from pre-PCC baseline was analyzed using mixed effect model, including treatment, sequence, and period as main effects. Hierarchical analysis was conducted with comparisons beginning with primary endpoint and continuing through secondary endpoints (ETP; TGA lag time; TGA time to peak; TGA peak; TGA velocity index; PT; INR; aPTT; AXA). If resulting p-value was \< 0.05, then the next comparison of interest was made until p\>0.05 at which point, comparisons ended.||-0.99|-1.95|<0.001
72587251|NCT02074358|144705450|SUPERIORITY_OR_OTHER||mixed effect model|-2.59|||<|0.001|TWO_SIDED|95.0|-3.3|-1.89||In the hierarchical analysis, no statistical inferences were drawn from the analysis results for this secondary endpoint since a non-significant treatment difference was observed for the first secondary endpoint (TGA lag time).|Mixed Models Analysis||Treatment B versus Treatment A|PT (Recombiplastin 2G). ETP change from pre-PCC baseline was analyzed using mixed effect model, including treatment, sequence, and period as main effects. Hierarchical analysis was conducted with comparisons beginning with primary endpoint and continuing through secondary endpoints (ETP; TGA lag time; TGA time to peak; TGA peak; TGA velocity index; PT; INR; aPTT; AXA). If resulting p-value was \< 0.05, then the next comparison of interest was made until p\>0.05 at which point, comparisons ended.||-1.89|-3.30|<0.001
72587252|NCT02074358|144705450|SUPERIORITY_OR_OTHER||mixed effect model|-1.89|||<|0.001|TWO_SIDED|95.0|-2.59|-1.2||In the hierarchical analysis, no statistical inferences were drawn from the analysis results for this secondary endpoint since a non-significant treatment difference was observed for the primary endpoint.|Mixed Models Analysis||Treatment C versus Treatment A|PT (Recombiplastin 2G). ETP change from pre-PCC baseline was analyzed using mixed effect model, including treatment, sequence, and period as main effects. Hierarchical analysis was conducted with comparisons beginning with primary endpoint and continuing through secondary endpoints (ETP; TGA lag time; TGA time to peak; TGA peak; TGA velocity index; PT; INR; aPTT; AXA). If resulting p-value was \< 0.05, then the next comparison of interest was made until p\>0.05 at which point, comparisons ended.||-1.20|-2.59|<0.001
72587253|NCT02074358|144705450|SUPERIORITY_OR_OTHER||mixed effect model|8.47|||<|0.001|TWO_SIDED|95.0|6.29|10.66||In the hierarchical analysis, no statistical inferences were drawn from the analysis results for this secondary endpoint since a non-significant treatment difference was observed for the first secondary endpoint (TGA lag time).|Mixed Models Analysis||Treatment B versus Treatment A|aPTT. The ETP change from pre-PCC baseline was analyzed using a mixed effect model and included treatment, sequence, and period as main effects. Hierarchical analysis was conducted with comparisons beginning with primary endpoint and continuing through secondary endpoints (ETP; TGA lag time; TGA time to peak; TGA peak; TGA velocity index; PT; INR; aPTT; AXA). If resulting p-value was \< 0.05, then the next comparison of interest was made until p\>0.05 at which point, comparisons ended.||10.66|6.29|<0.001
72587254|NCT02074358|144705450|SUPERIORITY_OR_OTHER||mixed effect model|2.3|||<|0.001|TWO_SIDED|95.0|1.28|3.32||In the hierarchical analysis, no statistical inferences were drawn from the analysis results for this secondary endpoint since a non-significant treatment difference was observed for the primary endpoint.|Mixed Models Analysis||Treatment C versus Treatment A|aPTT. ETP change from pre-PCC baseline was analyzed using mixed effect model, including treatment, sequence, and period as main effects. Hierarchical analysis was conducted with comparisons beginning with primary endpoint and continuing through secondary endpoints (ETP; TGA lag time; TGA time to peak; TGA peak; TGA velocity index; PT; INR; aPTT; AXA). If resulting p-value was \< 0.05, then the next comparison of interest was made until p\>0.05 at which point, comparisons ended.||3.32|1.28|<0.001
72587255|NCT02074358|144705451|SUPERIORITY_OR_OTHER||mixed effect model|-0.198|||<|0.001|TWO_SIDED|95.0|-0.266|-0.13||In the hierarchical analysis, no statistical inferences were drawn from the analysis results for this secondary endpoint since a non-significant treatment difference was observed for the first secondary endpoint (TGA lag time).|Mixed Models Analysis||Treatment B versus Treatment A|INR (Neoplastin CI+). ETP change from pre-PCC baseline was analyzed using mixed effect model, including treatment, sequence, and period as main effects. Hierarchical analysis was conducted with comparisons beginning with primary endpoint and continuing through secondary endpoints (ETP; TGA lag time; TGA time to peak; TGA peak; TGA velocity index; PT; INR; aPTT; AXA). If resulting p-value was \< 0.05, then the next comparison of interest was made until p\>0.05 at which point, comparisons ended.||-0.130|-0.266|<0.001
72587256|NCT02074358|144705451|SUPERIORITY_OR_OTHER||mixed effect model|-0.17|||<|0.001|TWO_SIDED|95.0|-0.229|-0.111||In the hierarchical analysis, no statistical inferences were drawn from the analysis results for this secondary endpoint since a non-significant treatment difference was observed for the primary endpoint.|Mixed Models Analysis||Treatment C versus Treatment A|INR (Neoplastin CI+). ETP change from pre-PCC baseline was analyzed using mixed effect model, including treatment, sequence, and period as main effects. Hierarchical analysis was conducted with comparisons beginning with primary endpoint and continuing through secondary endpoints (ETP; TGA lag time; TGA time to peak; TGA peak; TGA velocity index; PT; INR; aPTT; AXA). If resulting p-value was \< 0.05, then the next comparison of interest was made until p\>0.05 at which point, comparisons ended.||-0.111|-0.229|<0.001
72587257|NCT02074358|144705451|SUPERIORITY_OR_OTHER||mixed effect model|-0.239|||<|0.001|TWO_SIDED|95.0|-0.305|-0.173||In the hierarchical analysis, no statistical inferences were drawn from the analysis results for this secondary endpoint since a non-significant treatment difference was observed for the first secondary endpoint (TGA lag time).|Mixed Models Analysis||Treatment B versus Treatment A|INR (Recombiplastin 2G). ETP change from pre-PCC baseline was analyzed using mixed effect model, including treatment, sequence, and period as main effects. Hierarchical analysis was conducted with comparisons beginning with primary endpoint and continuing through secondary endpoints (ETP; TGA lag time; TGA time to peak; TGA peak; TGA velocity index; PT; INR; aPTT; AXA). If resulting p-value was \< 0.05, then the next comparison of interest was made until p\>0.05 at which point, comparisons ended.||-0.173|-0.305|<0.001
72587258|NCT02074358|144705451|SUPERIORITY_OR_OTHER||mixed effect model|-0.176|||<|0.001|TWO_SIDED|95.0|-0.242|-0.11||In the hierarchical analysis, no statistical inferences were drawn from the analysis results for this secondary endpoint since a non-significant treatment difference was observed for the primary endpoint.|Mixed Models Analysis||Treatment C versus Treatment A|INR (Recombiplastin 2G). ETP change from pre-PCC baseline was analyzed using mixed effect model, including treatment, sequence, and period as main effects. Hierarchical analysis was conducted with comparisons beginning with primary endpoint and continuing through secondary endpoints (ETP; TGA lag time; TGA time to peak; TGA peak; TGA velocity index; PT; INR; aPTT; AXA). If resulting p-value was \< 0.05, then the next comparison of interest was made until p\>0.05 at which point, comparisons ended.||-0.110|-0.242|<0.001
72587259|NCT02074358|144705452|SUPERIORITY_OR_OTHER||mixed effect models|-0.239||||0.204|TWO_SIDED|95.0|-0.625|0.146||In the hierarchical analysis, no statistical inferences were drawn from the analysis results for this secondary endpoint since a non-significant treatment difference was observed for the first secondary endpoint (TGA lag time).|Mixed Models Analysis||Treatment B versus Treatment A|Anti-Xa Activity. ETP change from pre-PCC baseline was analyzed using mixed effect model, including treatment, sequence, and period as main effects. Hierarchical analysis was conducted with comparisons beginning with primary endpoint and continuing through secondary endpoints (ETP; TGA lag time; TGA time to peak; TGA peak; TGA velocity index; PT; INR; aPTT; AXA). If resulting p-value was \< 0.05, then the next comparison of interest was made until p\>0.05 at which point, comparisons ended.||0.146|-0.625|0.204
72421548|NCT01181726|144354231|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|99.13|||||TWO_SIDED|90.0|94.39|104.1|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||104.10|94.39|
72587260|NCT02074358|144705452|SUPERIORITY_OR_OTHER||mixed effect models|-0.17||||0.114|TWO_SIDED|95.0|-0.389|0.048||In the hierarchical analysis, no statistical inferences were drawn from the analysis results for this secondary endpoint since a non-significant treatment difference was observed for the primary endpoint.|Mixed Models Analysis||Treatment C versus Treatment A|Anti-Xa Activity. ETP change from pre-PCC baseline was analyzed using mixed effect model, including treatment, sequence, and period as main effects. Hierarchical analysis was conducted with comparisons beginning with primary endpoint and continuing through secondary endpoints (ETP; TGA lag time; TGA time to peak; TGA peak; TGA velocity index; PT; INR; aPTT; AXA). If resulting p-value was \< 0.05, then the next comparison of interest was made until p\>0.05 at which point, comparisons ended.||0.048|-0.389|0.114
72587261|NCT02074358|144705462|SUPERIORITY_OR_OTHER||mixed effect model|1.039|||||TWO_SIDED|90.0|0.972|1.111|||||Treatment B versus Treatment A|Analysis used a linear mixed effect model including treatment, period, and sequence as fixed effects and within-participant measurements as repeated measures. Point estimates and 90% confidence intervals (CIs) for differences on the log scale were exponentiated to obtain estimates for ratios of geometric means on the original scale between each PCC treatment and placebo (ie, Treatment B versus Treatment A, and Treatment C versus Treatment A). No adjustment was made for multiplicity.||1.111|0.972|
72587262|NCT02074358|144705462|SUPERIORITY_OR_OTHER||mixed effect model|1.021|||||TWO_SIDED|90.0|0.938|1.112|||||Treatment C versus Treatment A|Analysis used a linear mixed effect model including treatment, period, and sequence as fixed effects and within-participant measurements as repeated measures. Point estimates and 90% confidence intervals (CIs) for differences on the log scale were exponentiated to obtain estimates for ratios of geometric means on the original scale between each PCC treatment and placebo (ie, Treatment C versus Treatment A). No adjustment was made for multiplicity.||1.112|0.938|
72587263|NCT02074358|144705464|SUPERIORITY_OR_OTHER||mixed effect model|1.019|||||TWO_SIDED|90.0|0.955|1.087|||||Treatment B versus Treatment A|Analysis used a linear mixed effect model including treatment, period, and sequence as fixed effects and within-participant measurements as repeated measures. Point estimates and 90% confidence intervals (CIs) for differences on the log scale were exponentiated to obtain estimates for ratios of geometric means on the original scale between each PCC treatment and placebo (ie, Treatment B versus Treatment A). No adjustment was made for multiplicity.||1.087|0.955|
72587264|NCT02074358|144705464|SUPERIORITY_OR_OTHER||mixed effect model|1.018|||||TWO_SIDED|90.0|0.94|1.102|||||Treatment C versus Treatment A|Analysis used a linear mixed effect model including treatment, period, and sequence as fixed effects and within-participant measurements as repeated measures. Point estimates and 90% confidence intervals (CIs) for differences on the log scale were exponentiated to obtain estimates for ratios of geometric means on the original scale between each PCC treatment and placebo (ie, Treatment C versus Treatment A). No adjustment was made for multiplicity.||1.102|0.940|
72587265|NCT01164579|144705481|SUPERIORITY_OR_OTHER||Difference in least squares (LS) Mean|-0.63|STANDARD_ERROR_OF_MEAN|0.57||0.2696|TWO_SIDED|90.0|-1.58|0.31||2-sided p-value; alpha equals (=) 0.10|mixed model repeated measures analysis|||||0.31|-1.58|0.2696
72587266|NCT01164579|144705481|SUPERIORITY_OR_OTHER||Difference in LS Mean|-0.52|STANDARD_ERROR_OF_MEAN|0.57||0.3561|TWO_SIDED|90.0|-1.46|0.41||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||||0.41|-1.46|0.3561
72587267|NCT01164579|144705482|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.55|STANDARD_ERROR_OF_MEAN|0.59||0.0089|TWO_SIDED|90.0|-2.52|-0.58||2-sided p-value; alpha= 0.10|mixed model repeated measures analysis|||||-0.58|-2.52|0.0089
72587268|NCT01164579|144705482|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.74|STANDARD_ERROR_OF_MEAN|0.59||0.0038|TWO_SIDED|90.0|-2.72|-0.76||2-sided p-value; alpha= 0.10|mixed model repeated measures analysis|||||-0.76|-2.72|0.0038
72587269|NCT01164579|144705483|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.25|STANDARD_ERROR_OF_MEAN|0.57||0.6576|TWO_SIDED|90.0|-1.19|0.69||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 1||0.69|-1.19|0.6576
72587270|NCT01164579|144705483|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.17|STANDARD_ERROR_OF_MEAN|0.55||0.7565|TWO_SIDED|90.0|-1.09|0.74||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 1||0.74|-1.09|0.7565
72587271|NCT01164579|144705483|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.94|STANDARD_ERROR_OF_MEAN|0.58||0.1038|TWO_SIDED|90.0|-1.89|0.01||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 6||0.01|-1.89|0.1038
72587272|NCT01164579|144705483|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.01|STANDARD_ERROR_OF_MEAN|0.59||0.0868|TWO_SIDED|90.0|-1.98|-0.04||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 6||-0.04|-1.98|0.0868
72587273|NCT01164579|144705483|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.6|STANDARD_ERROR_OF_MEAN|0.62||0.0103|TWO_SIDED|90.0|-2.62|-0.58||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 12||-0.58|-2.62|0.0103
72587274|NCT01164579|144705483|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.49|STANDARD_ERROR_OF_MEAN|0.63||0.435|TWO_SIDED|90.0|-1.53|0.55||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 12||0.55|-1.53|0.4350
72587275|NCT01164579|144705484|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.4|STANDARD_ERROR_OF_MEAN|0.58||0.489|TWO_SIDED|90.0|-1.36|0.56||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 1||0.56|-1.36|0.4890
72587276|NCT01164579|144705484|SUPERIORITY_OR_OTHER||Difference in LS Means|0.08|STANDARD_ERROR_OF_MEAN|0.57||0.8817|TWO_SIDED|90.0|-0.85|1.02||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 1||1.02|-0.85|0.8817
72587277|NCT01164579|144705484|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.24|STANDARD_ERROR_OF_MEAN|0.59||0.0351|TWO_SIDED|90.0|-2.21|-0.27||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 3||-0.27|-2.21|0.0351
72587278|NCT01164579|144705484|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.32|STANDARD_ERROR_OF_MEAN|0.58||0.0231|TWO_SIDED|90.0|-2.28|-0.37||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 3||-0.37|-2.28|0.0231
72587279|NCT01164579|144705484|SUPERIORITY_OR_OTHER||Difference in LS Means|-2.1|STANDARD_ERROR_OF_MEAN|0.62||0.0008|TWO_SIDED|90.0|-3.13|-1.08||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 12||-1.08|-3.13|0.0008
72587280|NCT01164579|144705484|SUPERIORITY_OR_OTHER||Difference in LS Means|-2.29|STANDARD_ERROR_OF_MEAN|0.63||0.0003|TWO_SIDED|90.0|-3.32|-1.25||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 12||-1.25|-3.32|0.0003
72587281|NCT01164579|144705485|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.39|STANDARD_ERROR_OF_MEAN|0.35||0.2689|TWO_SIDED|90.0|-0.96|0.19||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 1||0.19|-0.96|0.2689
72587282|NCT01164579|144705485|SUPERIORITY_OR_OTHER||Difference in LS Means|0.0|STANDARD_ERROR_OF_MEAN|0.35||0.9935|TWO_SIDED|90.0|-0.58|0.57||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 1||0.57|-0.58|0.9935
72587283|NCT01164579|144705485|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.57|STANDARD_ERROR_OF_MEAN|0.35||0.1086|TWO_SIDED|90.0|-1.15|0.01||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 3||0.01|-1.15|0.1086
72587284|NCT01164579|144705485|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.08|STANDARD_ERROR_OF_MEAN|0.35||0.8092|TWO_SIDED|90.0|-0.66|0.49||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 3||0.49|-0.66|0.8092
72587285|NCT01164579|144705485|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.71|STANDARD_ERROR_OF_MEAN|0.35||0.0463|TWO_SIDED|90.0|-1.29|-0.12||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 6||-0.12|-1.29|0.0463
72587286|NCT01164579|144705485|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.67|STANDARD_ERROR_OF_MEAN|0.35||0.0624|TWO_SIDED|90.0|-1.25|-0.08||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 6||-0.08|-1.25|0.0624
72587287|NCT01164579|144705485|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.29|STANDARD_ERROR_OF_MEAN|0.37||0.0005|TWO_SIDED|90.0|-1.9|-0.69||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 12||-0.69|-1.90|0.0005
72587288|NCT01164579|144705485|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.26|STANDARD_ERROR_OF_MEAN|0.37||0.0008|TWO_SIDED|90.0|-1.87|-0.65||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 12||-0.65|-1.87|0.0008
72587289|NCT01164579|144705486|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.48|STANDARD_ERROR_OF_MEAN|0.72||0.5019|TWO_SIDED|90.0|-1.68|0.71||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 6||0.71|-1.68|0.5019
72587290|NCT01164579|144705486|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.07|STANDARD_ERROR_OF_MEAN|0.73||0.1462|TWO_SIDED|90.0|-2.28|0.14||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 6||0.14|-2.28|0.1462
72587291|NCT01164579|144705486|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.51|STANDARD_ERROR_OF_MEAN|0.74||0.49|TWO_SIDED|90.0|-1.74|0.72||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 12||0.72|-1.74|0.4900
72587292|NCT01164579|144705486|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.51|STANDARD_ERROR_OF_MEAN|0.75||0.0459|TWO_SIDED|90.0|-2.76|-0.27|||mixed model repeated measures analysis|||Month 12||-0.27|-2.76|0.0459
72587293|NCT01164579|144705487|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.48|STANDARD_ERROR_OF_MEAN|0.72||0.5019|TWO_SIDED|90.0|-1.68|0.71||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 6||0.71|-1.68|0.5019
72587294|NCT01164579|144705487|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.07|STANDARD_ERROR_OF_MEAN|0.73||0.1462|TWO_SIDED|90.0|-2.28|0.14||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 6||0.14|-2.28|0.1462
72587295|NCT01164579|144705487|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.51|STANDARD_ERROR_OF_MEAN|0.74||0.49|TWO_SIDED|90.0|-1.74|0.72||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 12||0.72|-1.74|0.4900
72587296|NCT01164579|144705487|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.51|STANDARD_ERROR_OF_MEAN|0.75||0.0459|TWO_SIDED|90.0|-2.76|-0.27||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 12||-0.27|-2.76|0.0459
72587297|NCT01164579|144705488|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.07|STANDARD_ERROR_OF_MEAN|0.5||0.8959|TWO_SIDED|90.0|-0.89|0.76||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 6||0.76|-0.89|0.8959
72587298|NCT01164579|144705488|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.41|STANDARD_ERROR_OF_MEAN|0.5||0.4193|TWO_SIDED|90.0|-1.25|0.43||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 6||0.43|-1.25|0.4193
72587299|NCT01164579|144705488|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.29|STANDARD_ERROR_OF_MEAN|0.51||0.5764|TWO_SIDED|90.0|-1.13|0.56||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 12||0.56|-1.13|0.5764
72587300|NCT01164579|144705488|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.83|STANDARD_ERROR_OF_MEAN|0.52||0.1101|TWO_SIDED|90.0|-1.69|0.02||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 12||0.02|-1.69|0.1101
72587301|NCT01164579|144705489|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.07|STANDARD_ERROR_OF_MEAN|0.5||0.8959|TWO_SIDED|90.0|-0.89|0.76||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 6||0.76|-0.89|0.8959
72587302|NCT01164579|144705489|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.41|STANDARD_ERROR_OF_MEAN|0.5||0.4193|TWO_SIDED|90.0|-1.25|0.43||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 6||0.43|-1.25|0.4193
72587303|NCT01164579|144705489|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.29|STANDARD_ERROR_OF_MEAN|0.51||0.5764|TWO_SIDED|90.0|-1.13|0.56||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 12||0.56|-1.13|0.5764
72587304|NCT01164579|144705489|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.83|STANDARD_ERROR_OF_MEAN|0.52||0.1101|TWO_SIDED|90.0|-1.69|0.02||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 12||0.02|-1.69|0.1101
72587305|NCT01164579|144705490|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.42|STANDARD_ERROR_OF_MEAN|0.35||0.2351|TWO_SIDED|90.0|-1.0|0.16||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 6||0.16|-1.00|0.2351
72587306|NCT01164579|144705490|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.67|STANDARD_ERROR_OF_MEAN|0.36||0.0631|TWO_SIDED|90.0|-1.27|-0.08||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 6||-0.08|-1.27|0.0631
72587307|NCT01164579|144705490|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.23|STANDARD_ERROR_OF_MEAN|0.36||0.5369|TWO_SIDED|90.0|-0.83|0.38||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 12||0.38|-0.83|0.5369
72587308|NCT01164579|144705490|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.69|STANDARD_ERROR_OF_MEAN|0.37||0.062|TWO_SIDED|90.0|-1.31|-0.08||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 12||-0.08|-1.31|0.0620
72587309|NCT01164579|144705491|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.42|STANDARD_ERROR_OF_MEAN|0.35||0.2351|TWO_SIDED|90.0|-1.0|0.16||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 6||0.16|-1.00|0.2351
72587310|NCT01164579|144705491|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.67|STANDARD_ERROR_OF_MEAN|0.36||0.0631|TWO_SIDED|90.0|-1.27|-0.08||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 6||-0.08|-1.27|0.0631
72587311|NCT01164579|144705491|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.23|STANDARD_ERROR_OF_MEAN|0.36||0.5369|TWO_SIDED|90.0|-0.83|0.38||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 12||0.38|-0.83|0.5369
72587312|NCT01164579|144705491|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.69|STANDARD_ERROR_OF_MEAN|0.37||0.062|TWO_SIDED|90.0|-1.31|-0.08||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 12||-0.08|-1.31|0.0620
72587313|NCT01164579|144705492|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.12|STANDARD_ERROR_OF_MEAN|11.24||0.243|TWO_SIDED|90.0|-5.36|31.62|||Normal approximation to the binomial|||Month 1||31.62|-5.36|0.2430
72587314|NCT01164579|144705492|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|27.41|STANDARD_ERROR_OF_MEAN|11.24||0.0147|TWO_SIDED|90.0|8.91|45.9|||Normal approximation to the binomial|||Month 1||45.90|8.91|0.0147
72587315|NCT01164579|144705492|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|28.03|STANDARD_ERROR_OF_MEAN|11.25||0.0127|TWO_SIDED|90.0|9.51|46.54|||Normal approximation to the binomial|||Month 2||46.54|9.51|0.0127
72587316|NCT01164579|144705492|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|20.57|STANDARD_ERROR_OF_MEAN|11.45||0.0724|TWO_SIDED|90.0|1.73|39.41|||Normal approximation to the binomial|||Month 2||39.41|1.73|0.0724
72587317|NCT01164579|144705492|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|28.49|STANDARD_ERROR_OF_MEAN|10.85||0.0086|TWO_SIDED|90.0|10.63|46.35|||Normal approximation to the binomial|||Month 3||46.35|10.63|0.0086
72587318|NCT01164579|144705492|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.46|STANDARD_ERROR_OF_MEAN|11.55||0.2808|TWO_SIDED|90.0|-6.54|31.47|||Normal approximation to the binomial|||Month 3||31.47|-6.54|0.2808
72587319|NCT01164579|144705492|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|28.18|STANDARD_ERROR_OF_MEAN|11.16||0.0115|TWO_SIDED|90.0|9.81|46.55|||Normal approximation to the binomial|||Month 9||46.55|9.81|0.0115
72587320|NCT01164579|144705492|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|15.09|STANDARD_ERROR_OF_MEAN|11.56||0.1921|TWO_SIDED|90.0|-3.94|34.12|||Normal approximation to the binomial|||Month 9||34.12|-3.94|0.1921
72587321|NCT01164579|144705492|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|28.18|STANDARD_ERROR_OF_MEAN|11.16||0.0115|TWO_SIDED|90.0|9.81|46.55|||Normal approximation to the binomial|||Month 12||46.55|9.81|0.0115
72414000|NCT02265237|144337046|SUPERIORITY|97.5% CI was calculated using the Wilson score method; the lower confidence bound for the percentage of participants with sustained virologic response at 12 weeks after treatment must exceed 67% to achieve superiority. The predefined threshold of 67% was based on historical SVR rates for HCV genotype 4 (GT4)-infected subjects treated with pegIFN/RBV.|Percentage of Participants|93.4|||||TWO_SIDED|97.5|82.6|97.7|||||The confidence interval was calculated using the Wilson score method.|The overall 2-sided significance level of 0.05 was split between Part I (arms A and B) and Part II (arm C) using a Bonferroni corrected alpha level of 0.025 for each part. Additionally, a fixed sequence procedure for Part I was used to proceed through the primary efficacy comparisons in the following order: 1) test of superiority of arm B and 2) test of superiority of arm A. The primary outcome within Arm C was tested with a Bonferroni-corrected Type 1 error rate of 0.025 for superiority.||97.7|82.6|
72587322|NCT01164579|144705492|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|17.86|STANDARD_ERROR_OF_MEAN|11.5||0.1203|TWO_SIDED|90.0|-1.05|36.79|||Normal approximation to the binomial|||Month 12||36.79|-1.05|0.1203
72587323|NCT01164579|144705493|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|20.15|STANDARD_ERROR_OF_MEAN|7.58||0.0078|TWO_SIDED|90.0|7.68|32.62|||Normal approximation to the binomial|||Month 1||32.62|7.68|0.0078
72587324|NCT01164579|144705493|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|20.15|STANDARD_ERROR_OF_MEAN|7.58||0.0078|TWO_SIDED|90.0|7.68|32.62|||Normal approximation to the binomial|||Month 1||32.62|7.68|0.0078
72587325|NCT01164579|144705493|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|29.49|STANDARD_ERROR_OF_MEAN|10.37||0.0044|TWO_SIDED|90.0|12.43|46.56|||Normal approximation to the binomial|||Month 2||46.56|12.43|0.0044
72587326|NCT01164579|144705493|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|17.11|STANDARD_ERROR_OF_MEAN|9.92||0.0845|TWO_SIDED|90.0|0.79|33.43|||Normal approximation to the binomial|||Month 2||33.43|0.79|0.0845
72587327|NCT01164579|144705493|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|24.24|STANDARD_ERROR_OF_MEAN|11.0||0.0275|TWO_SIDED|90.0|6.14|42.35|||Normal approximation to the binomial|||Month 3||42.35|6.14|0.0275
72587328|NCT01164579|144705493|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|25.67|STANDARD_ERROR_OF_MEAN|10.91||0.0186|TWO_SIDED|90.0|7.71|43.63|||Normal approximation to the binomial|||Month 3||43.63|7.71|0.0186
72587329|NCT01164579|144705493|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|35.52|STANDARD_ERROR_OF_MEAN|10.75||0.0009|TWO_SIDED|90.0|17.82|53.22|||Normal approximation to the binomial|||Month 6||53.22|17.82|0.0009
72587330|NCT01164579|144705493|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|25.6|STANDARD_ERROR_OF_MEAN|10.72||0.0169|TWO_SIDED|90.0|7.95|43.24|||Normal approximation to the binomial|||Month 6||43.24|7.95|0.0169
72587331|NCT01164579|144705493|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|27.41|STANDARD_ERROR_OF_MEAN|11.24||0.0147|TWO_SIDED|90.0|8.91|45.9|||Normal approximation to the binomial|||Month 9||45.90|8.91|0.0147
72587332|NCT01164579|144705493|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.71|STANDARD_ERROR_OF_MEAN|11.18||0.1882|TWO_SIDED|90.0|-3.68|33.11|||Normal approximation to the binomial|||Month 9||33.11|-3.68|0.1882
72587333|NCT01164579|144705493|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|27.41|STANDARD_ERROR_OF_MEAN|11.24||0.0147|TWO_SIDED|90.0|8.91|45.9|||Normal approximation to the binomial|||Month 12||45.90|8.91|0.0147
72587334|NCT01164579|144705493|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.71|STANDARD_ERROR_OF_MEAN|11.18||0.1882|TWO_SIDED|90.0|-3.68|33.11|||Normal approximation to the binomial|||Month 12||33.11|-3.68|0.1882
72587335|NCT01164579|144705494|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.57|STANDARD_ERROR_OF_MEAN|4.73||0.07|TWO_SIDED|90.0|0.78|16.35|||Normal approximation to the binomial|||Month 1||16.35|0.78|0.0700
72587336|NCT01164579|144705494|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.85|STANDARD_ERROR_OF_MEAN|2.81||0.3102|TWO_SIDED|90.0|-1.77|7.48|||Normal approximation to the binomial|||Month 1||7.48|-1.77|0.3102
72587337|NCT01164579|144705494|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|26.02|STANDARD_ERROR_OF_MEAN|8.68||0.0027|TWO_SIDED|90.0|11.73|40.3|||Normal approximation to the binomial|||Month 2||40.30|11.73|0.0027
72587338|NCT01164579|144705494|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.81|STANDARD_ERROR_OF_MEAN|7.86||0.0324|TWO_SIDED|90.0|3.88|29.75|||Normal approximation to the binomial|||Month 2||29.75|3.88|0.0324
72587339|NCT01164579|144705494|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.9|STANDARD_ERROR_OF_MEAN|8.97||0.0969|TWO_SIDED|90.0|0.13|29.67|||Normal approximation to the binomial|||Month 3||29.67|0.13|0.0969
72587340|NCT01164579|144705494|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.96|STANDARD_ERROR_OF_MEAN|9.04||0.0606|TWO_SIDED|90.0|2.09|31.84|||Normal approximation to the binomial|||Month 3||31.84|2.09|0.0606
72587341|NCT01164579|144705494|SUPERIORITY_OR_OTHER||Mean Difference (Net)|12.66|STANDARD_ERROR_OF_MEAN|10.49||0.2276|TWO_SIDED|90.0|-4.6|29.93|||Normal approximation to the binomial|||Month 6||29.93|-4.60|0.2276
72587342|NCT01164579|144705494|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.93|STANDARD_ERROR_OF_MEAN|10.23||0.3827|TWO_SIDED|90.0|-7.9|25.76|||Normal approximation to the binomial|||Month 6||25.76|-7.90|0.3827
72587343|NCT01164579|144705494|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.5|STANDARD_ERROR_OF_MEAN|10.15||0.2177|TWO_SIDED|90.0|-4.18|29.2|||Normal approximation to the binomial|||Month 9||29.20|-4.18|0.2177
72587344|NCT01164579|144705494|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.41|STANDARD_ERROR_OF_MEAN|10.15||0.1558|TWO_SIDED|90.0|-2.29|31.12|||Normal approximation to the binomial|||Month 9||31.12|-2.29|0.1558
72587345|NCT01164579|144705494|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.23|STANDARD_ERROR_OF_MEAN|9.8||0.8997|TWO_SIDED|90.0|-14.89|17.36|||Normal approximation to the binomial|||Month 12||17.36|-14.89|0.8997
72587346|NCT01164579|144705494|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.71|STANDARD_ERROR_OF_MEAN|10.36||0.2587|TWO_SIDED|90.0|-5.34|28.76|||Normal approximation to the binomial|||Month 12||28.76|-5.34|0.2587
72587347|NCT01164579|144705495|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.22|||||TWO_SIDED|90.0|-0.56|0.13||||||Baseline||0.13|-0.56|
72587348|NCT01164579|144705495|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.12|||||TWO_SIDED|90.0|-0.19|0.43||||||Baseline||0.43|-0.19|
72587349|NCT01164579|144705495|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.94|||||TWO_SIDED|90.0|-1.38|-0.5||||||Month 1||-0.50|-1.38|
72587350|NCT01164579|144705495|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.62|||||TWO_SIDED|90.0|-1.01|-0.22||||||Month 1||-0.22|-1.01|
72587351|NCT01164579|144705495|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.21|||||TWO_SIDED|90.0|-1.73|-0.7||||||Month 2||-0.70|-1.73|
72587352|NCT01164579|144705495|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.69|||||TWO_SIDED|90.0|-1.2|-0.18||||||Month 2||-0.18|-1.20|
72587353|NCT01164579|144705495|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.81|||||TWO_SIDED|90.0|-1.33|-0.29||||||Month 3||-0.29|-1.33|
72587354|NCT01164579|144705495|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.41|||||TWO_SIDED|90.0|-0.94|0.12||||||Month 3||0.12|-0.94|
72587355|NCT01164579|144705495|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.18|||||TWO_SIDED|90.0|-1.75|-0.61||||||Month 6||-0.61|-1.75|
72587356|NCT01164579|144705495|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.18|||||TWO_SIDED|90.0|-1.73|-0.63||||||Month 6||-0.63|-1.73|
72587357|NCT01164579|144705495|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.21|||||TWO_SIDED|90.0|-1.81|-0.61||||||Month 9||-0.61|-1.81|
72587358|NCT01164579|144705495|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.73|||||TWO_SIDED|90.0|-1.33|-0.13||||||Month 9||-0.13|-1.33|
72587359|NCT01164579|144705495|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.1|||||TWO_SIDED|90.0|-1.69|-0.51||||||Month 12||-0.51|-1.69|
72587360|NCT01164579|144705495|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9|||||TWO_SIDED|90.0|-1.51|-0.29||||||Month 12||-0.29|-1.51|
72587361|NCT01164579|144705496|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.88|STANDARD_ERROR_OF_MEAN|0.26||0.001|TWO_SIDED|90.0|-1.31|-0.45||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 1||-0.45|-1.31|0.0010
72587362|NCT01164579|144705496|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.67|STANDARD_ERROR_OF_MEAN|0.26||0.0102|TWO_SIDED|90.0|-1.1|-0.24||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 1||-0.24|-1.10|0.0102
72587363|NCT01164579|144705496|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.08|STANDARD_ERROR_OF_MEAN|0.27|<|0.0001|TWO_SIDED|90.0|-1.52|-0.64||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 2||-0.64|-1.52|<0.0001
72587364|NCT01164579|144705496|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.64|STANDARD_ERROR_OF_MEAN|0.27||0.0175|TWO_SIDED|90.0|-1.08|-0.2||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 2||-0.20|-1.08|0.0175
72587365|NCT01164579|144705496|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.68|STANDARD_ERROR_OF_MEAN|0.27||0.0125|TWO_SIDED|90.0|-1.13|-0.23||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 3||-0.23|-1.13|0.0125
72587366|NCT01164579|144705496|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.39|STANDARD_ERROR_OF_MEAN|0.27||0.1457|TWO_SIDED|90.0|-0.84|0.05||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 3||0.05|-0.84|0.1457
72587367|NCT01164579|144705496|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.02|STANDARD_ERROR_OF_MEAN|0.28||0.0003|TWO_SIDED|90.0|-1.48|-0.57||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 6||-0.57|-1.48|0.0003
72587368|NCT01164579|144705496|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.03|STANDARD_ERROR_OF_MEAN|0.28||0.0002|TWO_SIDED|90.0|-1.49|-0.58||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 6||-0.58|-1.49|0.0002
72587369|NCT01164579|144705496|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.16|STANDARD_ERROR_OF_MEAN|0.28|<|0.0001|TWO_SIDED|90.0|-1.63|-0.69||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 9||-0.69|-1.63|<0.0001
72587370|NCT01164579|144705496|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.67|STANDARD_ERROR_OF_MEAN|0.28||0.0196|TWO_SIDED|90.0|-1.14|-0.2||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 9||-0.20|-1.14|0.0196
72587371|NCT01164579|144705496|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.01|STANDARD_ERROR_OF_MEAN|0.3||0.0007|TWO_SIDED|90.0|-1.5|-0.52||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 12||-0.52|-1.50|0.0007
72587372|NCT01164579|144705496|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.84|STANDARD_ERROR_OF_MEAN|0.3||0.0049|TWO_SIDED|90.0|-1.32|-0.35||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 12||-0.35|-1.32|0.0049
72414001|NCT02265237|144337047|SUPERIORITY|Treatment differences (with 95% confidence intervals) and corresponding P-value for the specified comparisons were estimated using stratum adjusted Mantel-Haenszel (MH) proportion and continuity-corrected variance, adjusting for IFN/RBV treatment history (treatment-naïve or treatment-experienced).|Stratum-Adjusted MH Difference|-3.39||||0.304|TWO_SIDED|95.0|-9.85|3.07|||Mantel Haenszel|||Within Part I (arm A and B), since superiority was demonstrated for both arms in the primary outcome measures, testing continued to the first secondary outcome measure.||3.07|-9.85|0.304
72587373|NCT01164579|144705497|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.19|||||TWO_SIDED|90.0|-0.53|0.15||||||Baseline||0.15|-0.53|
72587374|NCT01164579|144705497|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.06|||||TWO_SIDED|90.0|-0.24|0.36||||||Baseline||0.36|-0.24|
72587375|NCT01164579|144705497|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.91|||||TWO_SIDED|90.0|-1.4|-0.42||||||Month 1||-0.42|-1.40|
72587376|NCT01164579|144705497|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.58|||||TWO_SIDED|90.0|-1.01|-0.14||||||Month 1||-0.14|-1.01|
72587377|NCT01164579|144705497|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.28|||||TWO_SIDED|90.0|-1.82|-0.73||||||Month 2||-0.73|-1.82|
72587378|NCT01164579|144705497|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.69|||||TWO_SIDED|90.0|-1.25|-0.13||||||Month 2||-0.13|-1.25|
72587379|NCT01164579|144705497|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.96|||||TWO_SIDED|90.0|-1.55|-0.38||||||Month 3||-0.38|-1.55|
72587380|NCT01164579|144705497|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.51|||||TWO_SIDED|90.0|-1.12|0.11||||||Month 3||0.11|-1.12|
72587381|NCT01164579|144705497|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.43|||||TWO_SIDED|90.0|-2.13|-0.72||||||Month 6||-0.72|-2.13|
72587382|NCT01164579|144705497|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.24|||||TWO_SIDED|90.0|-1.91|-0.57||||||Month 6||-0.57|-1.91|
72587383|NCT01164579|144705497|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.11|||||TWO_SIDED|90.0|-1.84|-0.39||||||Month 9||-0.39|-1.84|
72587384|NCT01164579|144705497|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.59|||||TWO_SIDED|90.0|-1.3|0.13||||||Month 9||0.13|-1.30|
72587385|NCT01164579|144705497|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.11|||||TWO_SIDED|90.0|-1.84|-0.39||||||Month 12||-0.39|-1.84|
72587386|NCT01164579|144705497|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.66|||||TWO_SIDED|90.0|-1.43|0.11||||||Month 12||0.11|-1.43|
72587387|NCT01164579|144705498|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.84|STANDARD_ERROR_OF_MEAN|0.29||0.0046|TWO_SIDED|90.0|-1.32|-0.35||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 1||-0.35|-1.32|0.0046
72587388|NCT01164579|144705498|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.63|STANDARD_ERROR_OF_MEAN|0.29||0.0303|TWO_SIDED|90.0|-1.11|-0.15||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 1||-0.15|-1.11|0.0303
72587389|NCT01164579|144705498|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.18|STANDARD_ERROR_OF_MEAN|0.3||0.0001|TWO_SIDED|90.0|-1.69|-0.68||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 2||-0.68|-1.69|0.0001
72587390|NCT01164579|144705498|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.67|STANDARD_ERROR_OF_MEAN|0.3||0.0255|TWO_SIDED|90.0|-1.17|-0.18||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 2||-0.18|-1.17|0.0255
72587391|NCT01164579|144705498|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.89|STANDARD_ERROR_OF_MEAN|0.3||0.0035|TWO_SIDED|90.0|-1.39|-0.39||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 3||-0.39|-1.39|0.0035
72587392|NCT01164579|144705498|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.55|STANDARD_ERROR_OF_MEAN|0.3||0.0683|TWO_SIDED|90.0|-1.05|-0.05||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 3||-0.05|-1.05|0.0683
72587393|NCT01164579|144705498|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.29|STANDARD_ERROR_OF_MEAN|0.31|<|0.0001|TWO_SIDED|90.0|-1.81|-0.78||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 6||-0.78|-1.81|<0.0001
72587394|NCT01164579|144705498|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.08|STANDARD_ERROR_OF_MEAN|0.31||0.0006|TWO_SIDED|90.0|-1.59|-0.56||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 6||-0.56|-1.59|0.0006
72587395|NCT01164579|144705498|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.15|STANDARD_ERROR_OF_MEAN|0.32||0.0004|TWO_SIDED|90.0|-1.67|-0.62||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 9||-0.62|-1.67|0.0004
72587396|NCT01164579|144705498|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.58|STANDARD_ERROR_OF_MEAN|0.32||0.0706|TWO_SIDED|90.0|-1.1|-0.05||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 9||-0.05|-1.10|0.0706
72587397|NCT01164579|144705498|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.13|STANDARD_ERROR_OF_MEAN|0.33||0.0008|TWO_SIDED|90.0|-1.67|-0.58||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 12||-0.58|-1.67|0.0008
72587398|NCT01164579|144705498|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.66|STANDARD_ERROR_OF_MEAN|0.33||0.0466|TWO_SIDED|90.0|-1.21|-0.12||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 12||-0.12|-1.21|0.0466
72587399|NCT01164579|144705499|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|32.51|STANDARD_ERROR_OF_MEAN|11.04||0.0032|TWO_SIDED|90.0|14.34|50.68||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 1||50.68|14.34|0.0032
72587400|NCT01164579|144705499|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|28.18|STANDARD_ERROR_OF_MEAN|11.16||0.0115|TWO_SIDED|90.0|9.81|46.55||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 1||46.55|9.81|0.0115
72587401|NCT01164579|144705499|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|34.41|STANDARD_ERROR_OF_MEAN|9.48||0.0002|TWO_SIDED|90.0|18.81|50.02||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 2||50.02|18.81|0.0002
72587402|NCT01164579|144705499|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|23.79|STANDARD_ERROR_OF_MEAN|10.48||0.0231|TWO_SIDED|90.0|6.55|41.03||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 2||41.03|6.55|0.0231
72587403|NCT01164579|144705499|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|34.41|STANDARD_ERROR_OF_MEAN|9.48||0.0002|TWO_SIDED|90.0|18.81|50.02||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 3||50.02|18.81|0.0002
72587404|NCT01164579|144705499|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|21.02|STANDARD_ERROR_OF_MEAN|10.69||0.0493|TWO_SIDED|90.0|3.43|38.61||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 3||38.61|3.43|0.0493
72587405|NCT01164579|144705499|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|34.18|STANDARD_ERROR_OF_MEAN|9.88||0.0005|TWO_SIDED|90.0|17.92|50.43||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 6||50.43|17.92|0.0005
72587406|NCT01164579|144705499|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|23.72|STANDARD_ERROR_OF_MEAN|10.73||0.027|TWO_SIDED|90.0|6.07|41.37||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 6||41.37|6.07|0.0270
72587407|NCT01164579|144705499|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|33.46|STANDARD_ERROR_OF_MEAN|10.73||0.0018|TWO_SIDED|90.0|15.8|51.12||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 9||51.12|15.80|0.0018
72587408|NCT01164579|144705499|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|23.49|STANDARD_ERROR_OF_MEAN|11.22||0.0363|TWO_SIDED|90.0|5.02|41.96||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 9||41.96|5.02|0.0363
72587409|NCT01164579|144705499|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|36.4|STANDARD_ERROR_OF_MEAN|10.48||0.0005|TWO_SIDED|90.0|19.16|53.64||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 12||53.64|19.16|0.0005
72587410|NCT01164579|144705499|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|26.27|STANDARD_ERROR_OF_MEAN|11.08||0.0177|TWO_SIDED|90.0|8.04|44.5||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 12||44.50|8.04|0.0177
72587411|NCT01164579|144705500|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|22.52|STANDARD_ERROR_OF_MEAN|9.66||0.0197|TWO_SIDED|90.0|6.62|38.42||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 1||38.42|6.62|0.0197
72587412|NCT01164579|144705500|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.33|STANDARD_ERROR_OF_MEAN|8.16||0.4379|TWO_SIDED|90.0|-7.09|19.76||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 1||19.76|-7.09|0.4379
72587413|NCT01164579|144705500|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|28.37|STANDARD_ERROR_OF_MEAN|10.92||0.0093|TWO_SIDED|90.0|10.4|46.34||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 2||46.34|10.40|0.0093
72587414|NCT01164579|144705500|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.48|STANDARD_ERROR_OF_MEAN|10.48||0.1669|TWO_SIDED|90.0|-2.75|31.73||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 2||31.73|-2.75|0.1669
72587415|NCT01164579|144705500|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|28.37|STANDARD_ERROR_OF_MEAN|10.92||0.0093|TWO_SIDED|90.0|10.4|46.34||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 3||46.34|10.40|0.0093
72587416|NCT01164579|144705500|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|20.04|STANDARD_ERROR_OF_MEAN|10.64||0.0596|TWO_SIDED|90.0|2.53|37.55||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 3||37.55|2.53|0.0596
72587417|NCT01164579|144705500|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|34.73|STANDARD_ERROR_OF_MEAN|11.07||0.0017|TWO_SIDED|90.0|16.51|52.96||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 6||52.96|16.51|0.0017
72587418|NCT01164579|144705500|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|28.52|STANDARD_ERROR_OF_MEAN|11.04||0.0097|TWO_SIDED|90.0|10.36|46.69||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 6||46.69|10.36|0.0097
72587419|NCT01164579|144705500|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|34.97|STANDARD_ERROR_OF_MEAN|11.11||0.0016|TWO_SIDED|90.0|16.68|53.26||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 9||53.26|16.68|0.0016
72587420|NCT01164579|144705500|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|28.6|STANDARD_ERROR_OF_MEAN|11.13||0.0102|TWO_SIDED|90.0|10.28|46.91||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 9||46.91|10.28|0.0102
72587421|NCT01164579|144705500|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|34.73|STANDARD_ERROR_OF_MEAN|11.07||0.0017|TWO_SIDED|90.0|16.51|52.96||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 12||52.96|16.51|0.0017
72587422|NCT01164579|144705500|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|22.97|STANDARD_ERROR_OF_MEAN|11.07||0.0381|TWO_SIDED|90.0|4.74|41.19||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 12||41.19|4.74|0.0381
72587423|NCT01164579|144705501|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.77|STANDARD_ERROR_OF_MEAN|7.67||0.0959|TWO_SIDED|90.0|0.15|25.4||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 1||25.40|0.15|0.0959
72587424|NCT01164579|144705501|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3|STANDARD_ERROR_OF_MEAN|5.4||0.9544|TWO_SIDED|90.0|-8.58|9.19||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 1||9.19|-8.58|0.9544
72587425|NCT01164579|144705501|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|27.18|STANDARD_ERROR_OF_MEAN|9.34||0.0036|TWO_SIDED|90.0|11.81|42.55||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 2||42.55|11.81|0.0036
72587426|NCT01164579|144705501|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.55|STANDARD_ERROR_OF_MEAN|7.66||0.264|TWO_SIDED|90.0|-4.04|21.16||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 2||21.16|-4.04|0.2640
72587427|NCT01164579|144705501|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|18.83|STANDARD_ERROR_OF_MEAN|9.79||0.0544|TWO_SIDED|90.0|2.72|34.95||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 3||34.95|2.72|0.0544
72587428|NCT01164579|144705501|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.7|STANDARD_ERROR_OF_MEAN|8.92||0.329|TWO_SIDED|90.0|-5.96|23.38||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 3||23.38|-5.96|0.3290
72587429|NCT01164579|144705501|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|30.84|STANDARD_ERROR_OF_MEAN|10.48||0.0032|TWO_SIDED|90.0|13.59|48.09||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 6||48.09|13.59|0.0032
72587430|NCT01164579|144705501|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|17.11|STANDARD_ERROR_OF_MEAN|9.92||0.0845|TWO_SIDED|90.0|0.79|33.43||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 6||33.43|0.79|0.0845
72587431|NCT01164579|144705501|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|31.08|STANDARD_ERROR_OF_MEAN|10.72||0.0037|TWO_SIDED|90.0|13.44|48.72||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 9||48.72|13.44|0.0037
72587432|NCT01164579|144705501|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|19.96|STANDARD_ERROR_OF_MEAN|10.36||0.054|TWO_SIDED|90.0|2.91|37.02||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 9||37.02|2.91|0.0540
72587433|NCT01164579|144705501|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|33.54|STANDARD_ERROR_OF_MEAN|10.24||0.001|TWO_SIDED|90.0|16.7|50.39||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 12||50.39|16.70|0.0010
72587434|NCT01164579|144705501|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|19.81|STANDARD_ERROR_OF_MEAN|9.66||0.0401|TWO_SIDED|90.0|3.92|35.71||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 12||35.71|3.92|0.0401
72587435|NCT01164579|144705502|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|37.91|STANDARD_ERROR_OF_MEAN|10.99||0.0005|TWO_SIDED|90.0|19.83|55.99||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 1||55.99|19.83|0.0005
72587436|NCT01164579|144705502|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|33.12|STANDARD_ERROR_OF_MEAN|11.09||0.0028|TWO_SIDED|90.0|14.87|51.38||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 1||51.38|14.87|0.0028
72587437|NCT01164579|144705502|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|25.83|STANDARD_ERROR_OF_MEAN|10.1||0.0105|TWO_SIDED|90.0|9.21|42.45||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 2||42.45|9.21|0.0105
72587438|NCT01164579|144705502|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.98|STANDARD_ERROR_OF_MEAN|11.13||0.37|TWO_SIDED|90.0|-8.33|28.3||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 2||28.30|-8.33|0.3700
72587439|NCT01164579|144705502|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|39.82|STANDARD_ERROR_OF_MEAN|9.54|<|0.0001|TWO_SIDED|90.0|24.11|55.53||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 3||55.53|24.11|<0.0001
72587440|NCT01164579|144705502|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|18.09|STANDARD_ERROR_OF_MEAN|11.24||0.1076|TWO_SIDED|90.0|-0.4|36.59||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 3||36.59|-0.40|0.1076
72587441|NCT01164579|144705502|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|33.94|STANDARD_ERROR_OF_MEAN|10.21||0.0008|TWO_SIDED|90.0|17.13|50.75||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 6||50.75|17.13|0.0008
72587442|NCT01164579|144705502|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|26.42|STANDARD_ERROR_OF_MEAN|10.74||0.0139|TWO_SIDED|90.0|8.74|44.1||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 6||44.10|8.74|0.0139
72587443|NCT01164579|144705502|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|36.4|STANDARD_ERROR_OF_MEAN|10.48||0.0005|TWO_SIDED|90.0|19.16|53.64||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 9||53.64|19.16|0.0005
72587444|NCT01164579|144705502|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|26.27|STANDARD_ERROR_OF_MEAN|11.08||0.0177|TWO_SIDED|90.0|8.04|44.5|||Normal approximation to the binomial|||Month 9||44.50|8.04|0.0177
72587445|NCT01164579|144705502|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|33.46|STANDARD_ERROR_OF_MEAN|10.73||0.0018|TWO_SIDED|90.0|15.8|51.12||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 12||51.12|15.80|0.0018
72587446|NCT01164579|144705502|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|23.49|STANDARD_ERROR_OF_MEAN|11.22||0.0363|TWO_SIDED|90.0|5.02|41.96||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 12||41.96|5.02|0.0363
72587447|NCT01164579|144705503|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|17.88|STANDARD_ERROR_OF_MEAN|7.42||0.016|TWO_SIDED|90.0|5.66|30.1||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 1||30.10|5.66|0.0160
72587448|NCT01164579|144705503|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.86|STANDARD_ERROR_OF_MEAN|5.43||0.2798|TWO_SIDED|90.0|-3.06|14.8||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 1||14.80|-3.06|0.2798
72587449|NCT01164579|144705503|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|27.18|STANDARD_ERROR_OF_MEAN|9.34||0.0036|TWO_SIDED|90.0|11.81|42.55||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 2||42.55|11.81|0.0036
72587450|NCT01164579|144705503|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.78|STANDARD_ERROR_OF_MEAN|7.3||0.4287|TWO_SIDED|90.0|-6.23|17.79||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 2||17.79|-6.23|0.4287
72587451|NCT01164579|144705503|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|18.83|STANDARD_ERROR_OF_MEAN|9.79||0.0544|TWO_SIDED|90.0|2.72|34.95||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 3||34.95|2.72|0.0544
72587452|NCT01164579|144705503|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|17.04|STANDARD_ERROR_OF_MEAN|9.51||0.0732|TWO_SIDED|90.0|1.39|32.69||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 3||32.69|1.39|0.0732
72587453|NCT01164579|144705503|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|22.25|STANDARD_ERROR_OF_MEAN|10.61||0.036|TWO_SIDED|90.0|4.79|39.72||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 6||39.72|4.79|0.0360
72587454|NCT01164579|144705503|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.85|STANDARD_ERROR_OF_MEAN|9.85||0.3688|TWO_SIDED|90.0|-7.35|25.07||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 6||25.07|-7.35|0.3688
72587455|NCT01164579|144705503|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|25.19|STANDARD_ERROR_OF_MEAN|10.67||0.0182|TWO_SIDED|90.0|7.63|42.76||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 9||42.76|7.63|0.0182
72587456|NCT01164579|144705503|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.41|STANDARD_ERROR_OF_MEAN|10.15||0.1558|TWO_SIDED|90.0|-2.29|31.12||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 9||31.12|-2.29|0.1558
72587457|NCT01164579|144705503|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|33.78|STANDARD_ERROR_OF_MEAN|10.49||0.0012|TWO_SIDED|90.0|16.51|51.05||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 12||51.05|16.51|0.0012
72587458|NCT01164579|144705503|SUPERIORITY_OR_OTHER||Mean Difference (Net)|14.33|STANDARD_ERROR_OF_MEAN|9.78||0.1426|TWO_SIDED|90.0|-1.74|30.42||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 12||30.42|-1.74|0.1426
72587459|NCT01164579|144705504|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.88|STANDARD_ERROR_OF_MEAN|4.03||0.1449|TWO_SIDED|90.0|-0.75|12.52||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 1||12.52|-0.75|0.1449
72587460|NCT01164579|144705504|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.85|STANDARD_ERROR_OF_MEAN|2.81||0.3102|TWO_SIDED|90.0|-1.77|7.48||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 1||7.48|-1.77|0.3102
72587461|NCT01164579|144705504|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.94|STANDARD_ERROR_OF_MEAN|7.06||0.0342|TWO_SIDED|90.0|3.32|26.55||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 2||26.55|3.32|0.0342
72587462|NCT01164579|144705504|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.85|STANDARD_ERROR_OF_MEAN|4.65||0.54|TWO_SIDED|90.0|-4.8|10.51||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 2||10.51|-4.80|0.5400
72587463|NCT01164579|144705504|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.01|STANDARD_ERROR_OF_MEAN|9.19||0.2759|TWO_SIDED|90.0|-5.1|25.13||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 3||25.13|-5.10|0.2759
72587464|NCT01164579|144705504|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.73|STANDARD_ERROR_OF_MEAN|6.25||0.0859|TWO_SIDED|90.0|-21.02|-0.45||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 3||-0.45|-21.02|0.0859
72587465|NCT01164579|144705504|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|15.89|STANDARD_ERROR_OF_MEAN|9.62||0.0985|TWO_SIDED|90.0|0.06|31.73||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 6||31.73|0.06|0.0985
72587466|NCT01164579|144705504|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.37|STANDARD_ERROR_OF_MEAN|8.05||0.9628|TWO_SIDED|90.0|-12.86|13.61||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 6||13.61|-12.86|0.9628
72587467|NCT01164579|144705504|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|19.07|STANDARD_ERROR_OF_MEAN|10.19||0.0612|TWO_SIDED|90.0|2.31|35.84||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 9||35.84|2.31|0.0612
72587468|NCT01164579|144705504|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.32|STANDARD_ERROR_OF_MEAN|8.36||0.7807|TWO_SIDED|90.0|-16.08|11.43||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 9||11.43|-16.08|0.7807
72587469|NCT01164579|144705504|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|18.83|STANDARD_ERROR_OF_MEAN|9.79||0.0544|TWO_SIDED|90.0|2.72|34.95||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 12||34.95|2.72|0.0544
72587470|NCT01164579|144705504|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.93|STANDARD_ERROR_OF_MEAN|8.66||0.4937|TWO_SIDED|90.0|-8.32|20.18||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 12||20.18|-8.32|0.4937
72587471|NCT01050582|144705545|SUPERIORITY_OR_OTHER||Slope|0.447|STANDARD_ERROR_OF_MEAN|0.116|<|0.001|TWO_SIDED|95.0|0.22|0.674|||Regression, Linear|Covariates: weight (wt) divided expected wt for age and height (ht), age, use of concomitant medication with growth effects, preexposure ht z-score.|Slope associated with treatment dummy variable with 1 indicating risperidone and 0 indicating other atypical antipychotics.|Null hypothesis is that there is no difference between the risperidone and other atypical antipsychotics groups in current height z-score.||0.674|0.220|<0.001
72587472|NCT01050582|144705546|SUPERIORITY_OR_OTHER||Slope|-0.221|STANDARD_ERROR_OF_MEAN|0.25||0.378|TWO_SIDED|95.0|-0.711|0.269|||Regression, Linear|Covariates: Tanner stage and gender|Slope associated with treatment dummy variable with 1 indicating risperidone and 0 indicating other atypical antipsychotics.|The null hypothesis is that there is no difference between the risperidone and other atypical antipsychotics groups in age (years) at current Tanner stage.||0.269|-0.711|0.378
72587473|NCT01050582|144705547|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.865|||>|0.999||95.0|0.189|3.963|||Fisher Exact||Estimated OR is from a logistic regression model including factors for treatment arm, age, indication, and use of concomitant medication with growth effects.|Null hypothesis is that there is no difference between the risperidone and other atypical antipsychotics groups in frequency of retrospectively reported potentially prolactin-related adverse events||3.963|0.189|>0.999
72587474|NCT00885664|144705553|SUPERIORITY|||||||0.45|||||||Wilcoxon (Mann-Whitney)|||||||0.45
72587475|NCT00885664|144705554|SUPERIORITY|||||||0.003|||||||Wilcoxon (Mann-Whitney)|||||||0.003
72587476|NCT00885664|144705555|SUPERIORITY|||||||0.91|||||||Wilcoxon (Mann-Whitney)|||||||0.91
72587477|NCT00885664|144705556|SUPERIORITY|||||||0.81|||||||Wilcoxon (Mann-Whitney)|||||||0.81
72587478|NCT00885664|144705557|SUPERIORITY|||||||0.99|||||||Wilcoxon (Mann-Whitney)|||||||0.99
72587479|NCT00885664|144705558|SUPERIORITY|||||||0.95|||||||Wilcoxon (Mann-Whitney)|||||||0.95
72587480|NCT00885664|144705559|SUPERIORITY|||||||0.01|||||||Wilcoxon (Mann-Whitney)|||||||0.01
72587481|NCT00885664|144705560|SUPERIORITY|||||||0.002|||||||Wilcoxon (Mann-Whitney)|||||||0.002
72587482|NCT00885664|144705561|SUPERIORITY|||||||0.05|||||||Wilcoxon (Mann-Whitney)|||||||0.05
72587483|NCT00885664|144705562|SUPERIORITY|||||||0.06|||||||Wilcoxon (Mann-Whitney)|||||||0.06
72587484|NCT00885664|144705563|SUPERIORITY|||||||0.33|||||||Wilcoxon (Mann-Whitney)|||||||0.33
72587485|NCT03980145|144705578|SUPERIORITY|||||||0.405||||||Statistical significance set at .05|ANOVA|||Null hypothesis is no difference between the two groups||||.405
72587486|NCT03980145|144705578|SUPERIORITY|||||||0.133|||||||ANOVA|||Null hypothesis is no difference between pretest and posttest||||.133
72587487|NCT03980145|144705578|SUPERIORITY|||||||0.05|||||||ANOVA|||Evaluated the difference between the pretest and posttest within the conventional physical therapy group||||.050
72587488|NCT03980145|144705578|SUPERIORITY||Mean Difference (Final Values)|0.07||||0.017|TWO_SIDED|95.0|0.015|0.124||p value was adjusted for multiple comparisons using a Bonferroni correction|ANOVA|||Evaluating the impact of whether comfortable walking speed for both groups combined resulted in a significant improvement in walking speed||.124|.015|.017
72587489|NCT03980145|144705579|SUPERIORITY|||||||0.369|||||||ANOVA|||Comparison of the impact between the two arms looking an improved walking endurance||||.369
72587490|NCT03980145|144705579|SUPERIORITY|||||||0.71|||||||ANOVA|||Evaluation of impact of end-effector robotic training alone||||.710
72587491|NCT03980145|144705579|SUPERIORITY|||||||0.682|||||||ANOVA|||Evaluating the impact of conventional therapy on walking endurance Null hypothesis is no difference between pretest and posttest||||.682
72587492|NCT03980145|144705579|SUPERIORITY|||||||0.568||||||p value adjusted for multiple comparisons - Bonferroni|ANOVA|||Evaluating the impact of whether both groups combined resulted in a significant change in walking distance||||.568
72587493|NCT03980145|144705580|SUPERIORITY|||||||0.594||||||Outcome specific to the physical domain|ANOVA|||Evaluation of the physical domain||||.594
72587494|NCT03980145|144705580|SUPERIORITY|||||||0.061|||||||ANOVA|||Pretest- Posttest End Effector Robotic Training Comparison for the Physical Domain||||.061
72587495|NCT03980145|144705580|SUPERIORITY|||||||0.812|||||||ANOVA|||Pretest posttest comparison of conventional training group for physical domain||||.812
72587496|NCT03980145|144705580|SUPERIORITY|||||||0.235|||||||ANOVA|||Combined conventional and end-effector training for outcomes in the physical domain||||.235
72587497|NCT03980145|144705580|SUPERIORITY|||||||0.465|||||||ANOVA|||Between group assessment of changes in the MFIS Cognitive domain||||.465
72587498|NCT03980145|144705580|SUPERIORITY|||||||0.165|||||||ANOVA|||Within group differences for the End Effector Robotic Training Group for the Cognitive Domain||||.165
72587499|NCT03980145|144705580|SUPERIORITY|||||||0.682|||||||ANOVA|||Within group assessment for the conventional group within the cognitive domain of the MFIS||||.682
72587500|NCT03980145|144705580|SUPERIORITY||Mean Difference (Final Values)|5.39||||0.017|TWO_SIDED|95.0|1.12|9.67||p value adjusted using a Bonferroni correction|ANOVA|||Combined group outcomes comparing pretest to posttest for the cognitive domain||9.67|1.12|.017
72414002|NCT02265237|144337048|SUPERIORITY|Treatment differences (with 95% confidence intervals) and corresponding P-value for the specified comparisons were estimated using stratum adjusted Mantel-Haenszel proportion and continuity-corrected variance, adjusting for IFN/RBV treatment history (treatment-naïve or treatment-experienced).|Stratum-Adjusted MH Difference|6.45||||0.086|TWO_SIDED|95.0|-0.91|13.81|||Mantel Haenszel|||Within Part II (arm C), since superiority was demonstrated for the primary outcome measure, testing continued to the second secondary outcome measure.||13.81|-0.91|0.086
72587501|NCT03980145|144705580|SUPERIORITY|||||||0.052|||||||ANOVA|||Between group comparison for the MFIS Psychological Subscale||||.052
72587502|NCT03980145|144705580|SUPERIORITY|||||||0.483|||||||ANOVA|||Within group comparison for the end-effector robotic training group for the MFIS Psychological subscale||||.483
72587503|NCT03980145|144705580|SUPERIORITY|||||||0.056|||||||ANOVA|||Within group assessment for the conventional physical therapy group for the MFIS Psychological subscale||||.056
72587504|NCT03980145|144705580|SUPERIORITY||Mean Difference (Final Values)|1.313||||0.048|TWO_SIDED|95.0|0.016|2.619||p value is adjusted for multiple comparisons using a Bonferroni correction|ANOVA|||Change in MFIS for all subjects from pre to posttest for the psychological subscale||2.619|.016|.048
72587505|NCT03980145|144705580|SUPERIORITY|||||||0.01|||||||ANOVA|||Between group assessment of differences in total score||||.010
72587506|NCT03980145|144705580|SUPERIORITY|||||||0.089|||||||ANOVA|||Within assessment of change in total fatigue score||||.089
72587507|NCT03980145|144705580|SUPERIORITY|||||||0.5|||||||ANOVA|||Within group assessment of change in total score||||.50
72587508|NCT03980145|144705580|SUPERIORITY||Mean Difference (Final Values)|9.464||||0.1|TWO_SIDED|95.0|2.678|16.251|||ANOVA|||Combined assessment of all subject improvement in total MFIS score||16.251|2.678|0.10
72587509|NCT03980145|144705581|SUPERIORITY|||||||0.071|||||||ANOVA|||Null hypothesis set for no difference between groups Assessment of between group differences for the physical subscale||||.071
72587510|NCT03980145|144705581|SUPERIORITY||Mean Difference (Final Values)|14.84||||0.005|TWO_SIDED|95.0|6.02|23.66|||ANOVA|||With group assessment of change on the physical subscale of the MSIS||23.66|6.02|.005
72587511|NCT03980145|144705581|SUPERIORITY||Mean Difference (Final Values)|13.57||||0.001|TWO_SIDED|95.0|8.3|18.85|||ANOVA|||With group assessment of change on the physical subscale of the MSIS||18.85|8.30|.001
72414003|NCT00839072|144337072|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence is established when the ratio of geometric Least Squares means (LS means) and confidence interval calculated from the exponential of the difference between the Test and Reference product for the ln-transformed parameter Cmax does not exceed 125%.|Ratio of the mean|59.66|||||TWO_SIDED|90.0|50.99|69.81|||||Trazodone Contramid® OAD/Desyrel®|||69.81|50.99|
72587512|NCT03980145|144705581|SUPERIORITY||Mean Difference (Final Values)|14.21||||2.6e-05|TWO_SIDED|95.0|9.367|19.04||p value adjusted for multiple comparisons using Bonferroni|ANOVA|||Combined group assessment of change on the physical subscale of the MSIS||19.04|9.367|.000026
72414004|NCT00839072|144337073|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence is established when the ratio of geometric Least Squares means and confidence interval calculated from the exponential of the difference between the Test and Reference product for the ln-transformed parameter AUCT is between 80% and 125%.|Ratio of the mean|78.55|||||TWO_SIDED|90.0|69.7|88.51|||||Trazodone Contramid® OAD/Desyrel®|||88.51|69.70|
72587513|NCT03980145|144705581|SUPERIORITY|||||||0.084||||||Pretest measures were statistically different between the two groups|ANOVA|||Between group comparison for the psychological subscale for the MSIS||||.084
72587514|NCT03980145|144705581|SUPERIORITY|||||||0.412|||||||ANOVA|||Within group comparison for the psychological subscale for the MSIS||||.412
72587515|NCT03980145|144705581|SUPERIORITY||Mean Difference (Final Values)|22.22||||0.00018|TWO_SIDED|95.0|15.59|28.85|||ANOVA|||Within group comparison for the psychological subscale for the MSIS||28.85|15.59|.00018
72587516|NCT03980145|144705581|SUPERIORITY||Mean Difference (Final Values)|13.19||||0.00049|TWO_SIDED|95.0|7.013|19.38|||ANOVA|||Combined group comparison for the psychological subscale for the MSIS||19.38|7.013|.00049
72587517|NCT03980145|144705582|SUPERIORITY|||||||0.352|||||||ANOVA|||Null hypothesis is no difference between the two groups||||.352
72587518|NCT03980145|144705582|SUPERIORITY|||||||0.079|||||||ANOVA|||Within group assessment||||.079
72587519|NCT03980145|144705582|SUPERIORITY|||||||0.393|||||||ANOVA|||Within group assessment||||.393
72587520|NCT03980145|144705582|SUPERIORITY||Mean Difference (Final Values)|0.058||||0.048|TWO_SIDED|95.0|0.001|0.116|||ANOVA|Adjusted for multiple mean comparisons||Evaluating the impact of whether fast walking speed for both groups combined resulted in a significant improvement in walking speed||.116|.001|.048
72414005|NCT00839072|144337074|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence is established when the ratio of geometric Least Squares means and confidence interval calculated from the exponential of the difference between the Test and Reference product for the ln-transformed parameter AUC∞ is between 80% and 125%.|Ratio of the mean|80.05|||||TWO_SIDED|90.0|70.67|90.68|||||Trazodone Contramid® OAD/Desyrel®|||90.68|70.67|
72414006|NCT05003791|144337078|OTHER|This was a cross-sectional design|||||<|0.05|||||||Regression, Linear|||||||<0.05
72414007|NCT05003791|144337079|OTHER|This was a cross-sectional design|||||<|0.05|||||||Regression, Linear|||||||<0.05
72587521|NCT03980145|144705583|SUPERIORITY|||||||0.117|||||||ANOVA|||Between group assessment for the HADS Anxiety Subscale||||.117
72587522|NCT03980145|144705583|SUPERIORITY||Mean Difference (Final Values)|1.75||||0.041|TWO_SIDED|95.0|0.093|3.407|||ANOVA|||Within group assessment for HADS Anxiety Subscale||3.407|.093|.041
72587523|NCT03980145|144705583|SUPERIORITY|||||||0.15|||||||ANOVA|||Within group assessment for HADS Anxiety Subscale||||.150
72587524|NCT03980145|144705583|SUPERIORITY||Mean Difference (Final Values)|1.518||||0.012|TWO_SIDED|95.0|0.39|2.646||p value adjusted for multiple comparisons|ANOVA|||Combined group assessment of HADS Anxiety Subscale||2.646|.390|.012
72587525|NCT03980145|144705584|SUPERIORITY|||||||0.239|||||||ANOVA|||||||.239
72587526|NCT03980145|144705584|SUPERIORITY|||||||0.667|||||||ANOVA|||Comparison between groups for differences in sensory pain score||||.667
72587527|NCT03980145|144705584|SUPERIORITY|||||||0.77|||||||ANOVA|||Between group differences in affective pain||||.770
72587528|NCT03980145|144705585|SUPERIORITY|||||||0.136|||||||ANOVA|||Between group assessment of LLFDI Disability Frequency||||.136
72587529|NCT03980145|144705585|SUPERIORITY|||||||0.833|||||||ANOVA|||Combined group assessment of improvement in LLFDI Disability Frequency||||.833
72587530|NCT03980145|144705585|SUPERIORITY||Mean Difference (Final Values)|6.996||||0.044|TWO_SIDED|95.0|0.212|13.781|||ANOVA|||Between Group Assessment of improvement in LLFDI Disability Limitations||13.781|.212|.044
72587531|NCT03980145|144705585|SUPERIORITY|||||||0.212|||||||ANOVA|||Combined group assessment of improvement in LLFDI Disability Limitations||||.212
72587532|NCT03980145|144705586|SUPERIORITY|||||||0.338|||||||ANOVA|||Between group comparison for the LLDFI Function||||.338
72587533|NCT03980145|144705586|SUPERIORITY||Mean Difference (Final Values)|7.508||||0.007|TWO_SIDED|95.0|2.73|12.28|||ANOVA|||Within group assessment of LLFDI Function||12.28|2.73|.007
72587534|NCT03980145|144705586|SUPERIORITY|||||||0.067|||||||ANOVA|||Within group assessment for changes in LLFDI Function||||.067
72587535|NCT03980145|144705586|SUPERIORITY||Mean Difference (Final Values)|5.99||||0.001|TWO_SIDED|95.0|2.9|9.08||p value adjusted for multiple comparisons|ANOVA|||Combined group improvement in LLFDI Function||9.08|2.90|.001
72587536|NCT00862823|144705598|NON_INFERIORITY_OR_EQUIVALENCE|The sample size was determined so there was an 80% chance that a 90% pairwise interval for 2 equivalent formulations would satifsy the FDA criteria for AUC and Cmax of log (0.8), log (1.2).|Geometric Mean Ratio|0.97|||<|0.05||90.0||||Bioequivalent measurew were log-transformed|log transformation|||||||<0.05
72587537|NCT01421225|144705602|EQUIVALENCE|The null hypothesis was that the number of hours would be the same (no effect of control).|Mean Difference (Final Values)|2.2||||0.12|TWO_SIDED|||||Statistical analysis was performed using a paired t-test.|t-test, 2 sided|||We tested the number of nighttime (10 PM - 8 AM) hours glucose was in the target range (110-200 mg/dL) on each of the two nights for which the patient was followed (one night under Standard Insulin Pump Therapy; one night under Closed-loop Insulin Therapy)||||0.12
72414008|NCT05003791|144337080|OTHER|This was a cross-sectional design|||||<|0.05|||||||Regression, Linear|||||||<0.05
72587538|NCT00911612|144705606|SUPERIORITY_OR_OTHER|||||||0.22||95.0||||Not adjusted since only one comparison was made.|ANCOVA|||An analysis of covariance was used to compare drug with placebo adjusting for baseline geometric center at 24 hours , BMI, and 7 alpha CHO.||||0.22
72587539|NCT00911612|144705607|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||ANCOVA|||An analysis of covariance was used to compare drug with placebo adjusting for BMI and 7 alpha HCO.||||0.02
72587540|NCT02049814|144705611|NON_INFERIORITY_OR_EQUIVALENCE|If the upper limit of 95% CI of Least Square Mean (LS mean) of HbA1C Changes was less than 0.4%, it was considered that the non-inferiority was established.||||||0.0001|||||||Paired t-test|||||||0.0001
72587541|NCT02307279|144705668|SUPERIORITY||Mean Difference (Net)|-2.07|STANDARD_ERROR_OF_MEAN|0.59||0.0007|TWO_SIDED|95.0|-3.24|-0.9|||ANCOVA|Adjusted for stratification factors, and baseline weight|Difference in adjusted mean taken for comparability between the two groups (treatment - placebo)|Simple Superiority, H0: μ (Placebo) -μ (Gelesis100) = 0||-0.90|-3.24|0.0007
72587542|NCT02307279|144705668|SUPERIORITY|||||||0.1193|||||||ANCOVA|Adjusted for stratification factors, and baseline weight||Super-Superiority (\>3% difference), H0: μ(Placebo)-μ(Gelesis100) \< 3%||||0.1193
72414009|NCT00380068|144337081|SUPERIORITY_OR_OTHER||Mean Difference (Net)|20.5|STANDARD_DEVIATION|65.64|<|0.001||95.0|11.8|29.3|||t-test, 2 sided|Paired t-test on change from Baseline to Week 24||||29.3|11.8|<0.001
72587543|NCT02307279|144705669|SUPERIORITY|The performance goal for body weight responders was set at 35%.|||||<|0.0001|||||||Binomial Proportion Test|||H0: π (Gelesis100)\< 0.35||||<0.0001
72587544|NCT02307279|144705669|SUPERIORITY||Odds Ratio (OR)|2.01||||0.0008|TWO_SIDED|95.0|1.34|3.01|||Regression, Logistic|Adjusted for stratification factors and baseline weight||"OR-trt refers to the odds ratio of being a body weight responder for Gelesis100 vs. Placebo.~H0: OR-trt= 1."||3.01|1.34|0.0008
72587545|NCT02484456|144705678|SUPERIORITY||Mean Difference (Final Values)|0.34|STANDARD_ERROR_OF_MEAN|0.79||0.68|TWO_SIDED||||||Mixed Models Analysis|||||||0.68
72587546|NCT02484456|144705679|SUPERIORITY||Mean Difference (Final Values)|-0.16|STANDARD_ERROR_OF_MEAN|0.72||0.83|TWO_SIDED||||||Mixed Models Analysis|||||||0.83
72414010|NCT00380068|144337082|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.5|STANDARD_DEVIATION|2.11|<|0.001||95.0|-0.8|-0.3|||t-test, 2 sided|Paired t-test on change from Baseline to Week 24||||-0.3|-0.8|<0.001
72414011|NCT00380068|144337083|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.6||||0.001||95.0|-1.0|-0.2|||t-test, 2 sided|Paired t-test on change from Baseline to Week 48||||-0.2|-1.0|0.001
72587547|NCT02484456|144705680|SUPERIORITY||Mean Difference (Final Values)|-0.34|STANDARD_ERROR_OF_MEAN|0.89||0.71|TWO_SIDED||||||Mixed Models Analysis|||||||0.71
72587548|NCT02484456|144705681|SUPERIORITY||Mean Difference (Final Values)|1.23|STANDARD_ERROR_OF_MEAN|1.06||0.25|TWO_SIDED||||||Mixed Models Analysis|||||||0.25
72587549|NCT02484456|144705682|SUPERIORITY||Mean Difference (Final Values)|-0.85|STANDARD_ERROR_OF_MEAN|1.27||0.51|TWO_SIDED||||||Mixed Models Analysis|||||||0.51
72587550|NCT02484456|144705683|SUPERIORITY||Mean Difference (Final Values)|-1.83|STANDARD_ERROR_OF_MEAN|1.58||0.26|TWO_SIDED||||||Mixed Models Analysis|||||||0.26
72587551|NCT02484456|144705684|SUPERIORITY||Mean Difference (Final Values)|0.44|STANDARD_ERROR_OF_MEAN|1.02||0.67|TWO_SIDED||||||Mixed Models Analysis|||||||0.67
72587552|NCT02484456|144705685|SUPERIORITY||Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|1.34||0.99|TWO_SIDED||||||Mixed Models Analysis|||||||0.99
72587553|NCT02484456|144705686|SUPERIORITY||Mean Difference (Final Values)|0.26|STANDARD_ERROR_OF_MEAN|1.2||0.83|TWO_SIDED||||||Mixed Models Analysis|||||||0.83
72587554|NCT02484456|144705687|SUPERIORITY||Mean Difference (Final Values)|-1.0|STANDARD_ERROR_OF_MEAN|1.51||0.51|TWO_SIDED||||||Mixed Models Analysis|||||||0.51
72587555|NCT02484456|144705688|SUPERIORITY||Mean Difference (Final Values)|-1.6|STANDARD_ERROR_OF_MEAN|1.76||0.37|TWO_SIDED||||||Mixed Models Analysis|||||||0.37
72587556|NCT02484456|144705689|SUPERIORITY||Mean Difference (Final Values)|-2.02|STANDARD_ERROR_OF_MEAN|1.89||0.29|TWO_SIDED||||||Mixed Models Analysis|||||||0.29
72587557|NCT02484456|144705690|SUPERIORITY||Mean Difference (Final Values)|0.49|STANDARD_ERROR_OF_MEAN|0.92||0.6|TWO_SIDED||||||Mixed Models Analysis|||||||0.60
72587558|NCT02484456|144705691|SUPERIORITY||Mean Difference (Final Values)|-0.63|STANDARD_ERROR_OF_MEAN|0.98||0.53|TWO_SIDED||||||Mixed Models Analysis|||||||0.53
72587559|NCT02484456|144705692|SUPERIORITY||Mean Difference (Final Values)|-0.17|STANDARD_ERROR_OF_MEAN|1.1||0.88|TWO_SIDED||||||Mixed Models Analysis|||||||0.88
72587560|NCT02484456|144705693|SUPERIORITY||Mean Difference (Final Values)|1.4|STANDARD_ERROR_OF_MEAN|0.91||0.13|TWO_SIDED||||||Mixed Models Analysis|||||||0.13
72587561|NCT02484456|144705694|SUPERIORITY||Mean Difference (Final Values)|-1.17|STANDARD_ERROR_OF_MEAN|1.3||0.38|TWO_SIDED||||||Mixed Models Analysis|||||||0.38
72587562|NCT02484456|144705695|SUPERIORITY||Mean Difference (Final Values)|-2.05|STANDARD_ERROR_OF_MEAN|1.26||0.12|TWO_SIDED||||||Mixed Models Analysis|||||||0.12
72414012|NCT00380068|144337084|SUPERIORITY_OR_OTHER||Percent change from baseline|-25.5||||||95.0|-33.6|-16.3|||||Percent change from baseline derived from Geometric Mean Ratio|||-16.3|-33.6|
72587563|NCT02484456|144705696|SUPERIORITY||Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|0.98||0.84|TWO_SIDED||||||Mixed Models Analysis|||||||0.84
72587564|NCT02484456|144705697|SUPERIORITY||Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|1.23||0.97|TWO_SIDED||||||Mixed Models Analysis|||||||0.97
72587565|NCT02484456|144705698|SUPERIORITY||Mean Difference (Final Values)|0.33|STANDARD_ERROR_OF_MEAN|1.39||0.81|TWO_SIDED||||||Mixed Models Analysis|||||||0.81
72587566|NCT02484456|144705699|SUPERIORITY||Mean Difference (Final Values)|0.96|STANDARD_ERROR_OF_MEAN|1.31||0.47|TWO_SIDED||||||Mixed Models Analysis|||||||0.47
72414013|NCT00380068|144337085|SUPERIORITY_OR_OTHER||Percent change from baseline|-29.2||||||95.0|-39.8|-16.6|||||Percent change from baseline derived from Geometric Mean Ratio|||-16.6|-39.8|
72587567|NCT02484456|144705700|SUPERIORITY||Mean Difference (Final Values)|-1.82|STANDARD_ERROR_OF_MEAN|1.89||0.35|TWO_SIDED||||||Mixed Models Analysis|||||||0.35
72587568|NCT02484456|144705701|SUPERIORITY||Mean Difference (Final Values)|-2.63|STANDARD_ERROR_OF_MEAN|1.63||0.12|TWO_SIDED||||||Mixed Models Analysis|||||||0.12
72587569|NCT02411396|144705756|OTHER|In order to eliminate bias from the naïve estimation on the treatment effects due to the confounders, time varying propensity score model was developed. This balanced the covariates between the two arms at each single acute visit of each patient. A sub classification on the propensity scores was used to estimate the potential outcome for each arm and the average treatment effects (ATE). Bootstrapping was employed to estimate the standard error of ATE.|Mean Difference (Final Values)|124.6|STANDARD_ERROR_OF_MEAN|3.2|||TWO_SIDED|95.0|118.3|130.9||||||This analysis is to compare outcome measure between ED or IC visits by using time varying propensity score method developed by our group to adjust imbalance of covariates between the two arms. Each patient can have multiple visits to the facility of choice.||130.9|118.3|
72587570|NCT02411396|144705757|OTHER|In order to eliminate bias from the naïve estimation on the treatment effects due to the confounders, time varying propensity score model was developed. This balanced the covariates between the two arms at each single acute visit of each patient. A sub classification on the propensity scores was used to estimate the potential outcome for each arm and the average treatment effects (ATE). Bootstrapping was employed to estimate the standard error of ATE.|Odds Ratio (OR)|5.14|||||TWO_SIDED|95.0|4.13|6.41|||||VOC in patients with SCD whom went to EDs represents the numerator, VOC in patients with SCD whom went to ICs represents the denominator for Odds Ratio.|||6.41|4.13|
72587571|NCT02411396|144705758|OTHER|In order to eliminate bias from the naïve estimation on the treatment effects due to the confounders, time varying propensity score model was developed. This balanced the covariates between the two arms at each single acute visit of each patient. A sub classification on the propensity scores was used to estimate the potential outcome for each arm and the average treatment effects (ATE). Bootstrapping was employed to estimate the standard error of ATE.|Odds Ratio (OR)|2.24|||||TWO_SIDED|95.0|1.84|2.72|||||VOC in patients with SCD whom went to ICs represents the numerator, VOC in patients with SCD whom went to EDs represents the denominator for Odds Ratio.|||2.72|1.84|
72587572|NCT06047366|144705810|OTHER|||||||0.18||||||p \< 0.05 was used as the threshold for statistical significance|Wilcoxon (Mann-Whitney)|||||||0.18
72587573|NCT06047366|144705811|OTHER|||||||0.09||||||p \< 0.05 was used as the threshold for statistical significance|Log Rank|||||||0.09
72587574|NCT03483961|144705812|SUPERIORITY|||||||0.0015||||||All tests were carried out at a 2-sided significance level of 0.05 and no adjustment for multiplicity was applied, since the goal was to rank different formulations rather than to establish inferential values.|ANOVA|ANOVA model including site and treatment group as fixed effects assuming normality of log titers. P-value is for Group 2 vs. Group 1.||Groups 2-8 are compared to Group 1.||||0.0015
72587575|NCT03483961|144705812|SUPERIORITY|||||||0.0761||||||All tests were carried out at a 2-sided significance level of 0.05 and no adjustment for multiplicity was applied, since the goal was to rank different formulations rather than to establish inferential values.|ANOVA|ANOVA model including site and treatment group as fixed effects assuming normality of log titers. P-value is for Group 3 vs. Group 1.||Groups 2-8 are compared to Group 1||||0.0761
72587576|NCT03483961|144705812|SUPERIORITY|||||||0.9317||||||All tests were carried out at a 2-sided significance level of 0.05 and no adjustment for multiplicity was applied, since the goal was to rank different formulations rather than to establish inferential values.|ANOVA|ANOVA model including site and treatment group as fixed effects assuming normality of log titers. P-value is for Group 4 vs. Group 1.||Groups 2-8 are compared to Group 1.||||0.9317
72587577|NCT03483961|144705812|SUPERIORITY||||||<|0.0001||||||All tests were carried out at a 2-sided significance level of 0.05 and no adjustment for multiplicity was applied, since the goal was to rank different formulations rather than to establish inferential values.|ANOVA|ANOVA model including site and treatment group as fixed effects assuming normality of log titers. P-value is for Group 5 vs. Group 1.||Groups 2-8 are compared to Group 1.||||<.0001
72587578|NCT03483961|144705812|SUPERIORITY|||||||0.0045||||||All tests were carried out at a 2-sided significance level of 0.05 and no adjustment for multiplicity was applied, since the goal was to rank different formulations rather than to establish inferential values.|ANOVA|ANOVA model including site and treatment group as fixed effects assuming normality of log titers. P-value is for Group 6 vs. Group 1.||Groups 2-8 are compared to Group 1.||||0.0045
72587579|NCT03483961|144705812|SUPERIORITY|||||||0.1437||||||All tests were carried out at a 2-sided significance level of 0.05 and no adjustment for multiplicity was applied, since the goal was to rank different formulations rather than to establish inferential values.|ANOVA|ANOVA model including site and treatment group as fixed effects assuming normality of log titers. P-value is for Group 7 vs. Group 1.||Groups 2-8 are compared to Group 1.||||0.1437
72587580|NCT03483961|144705812|SUPERIORITY|||||||0.3216||||||All tests were carried out at a 2-sided significance level of 0.05 and no adjustment for multiplicity was applied, since the goal was to rank different formulations rather than to establish inferential values.|ANOVA|ANOVA model including site and treatment group as fixed effects assuming normality of log titers. P-value is for Group 8 vs. Group 1.||Groups 2-8 are compared to Group 1.||||0.3216
72587581|NCT01262287|144705817|SUPERIORITY_OR_OTHER|||||||0.9|||||||t-test, 2 sided|||||||0.9
72587582|NCT01262287|144705818|SUPERIORITY_OR_OTHER|||||||0.9|||||||t-test, 2 sided|||||||0.9
72587583|NCT01262287|144705818|SUPERIORITY_OR_OTHER|||||||0.9|||||||t-test, 2 sided|||||||0.9
72414014|NCT00380068|144337086|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical test performed on actual change from baseline WHO functional Class (eg, a change from WHO Class III to II is -1; a change from WHO Class IV to II is -2; etc).|Wilcoxon signed-rank test|||||||<0.001
72414015|NCT00380068|144337087|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical test performed on actual change from baseline WHO functional Class (eg, a change from WHO Class III to II is -1; a change from WHO Class IV to II is -2; etc).|Wilcoxon signed-rank test|||||||<0.001
72587584|NCT02110758|144705830|OTHER|||||||0.025|||||||Regression, Logistic|||To estimate exposure to the intervention on the Access composite score, we used a difference-in-differences model with fixed effects for practices. The dependent variable was the composite score. The intervention effects were represented by the coefficient estimates for survey time period (pre or post) interacted with status (pilot or comparison).||||.025
72587585|NCT02110758|144705830|OTHER|||||||0.69|||||||Regression, Logistic|||To estimate exposure to the intervention on the Affective Communication composite score, we used a difference-in-differences model with fixed effects for practices. The dependent variable was the composite score. The intervention effects were represented by the coefficient estimates for survey time period (pre or post) interacted with status (pilot or comparison).||||0.69
72587586|NCT02110758|144705830|OTHER|||||||0.013|||||||Regression, Logistic|||To estimate exposure to the intervention on the Shared Decision-Making composite score, we used a difference-in-differences model with fixed effects for practices. The dependent variable was the composite score. The intervention effects were represented by the coefficient estimates for survey time period (pre or post) interacted with status (pilot or comparison).||||.013
72414016|NCT00380068|144337088|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|Paired t-test on change from Baseline to Week 24||||||<0.001
72414017|NCT00380068|144337089|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|Paired t-test on change from Baseline to Week 48||||||<0.001
72587587|NCT02110758|144705830|OTHER|||||||0.85|||||||Regression, Logistic|||To estimate exposure to the intervention on the Patient Self-Management composite score, we used a difference-in-differences model with fixed effects for practices. The dependent variable was the composite score. The intervention effects were represented by the coefficient estimates for survey time period (pre or post) interacted with status (pilot or comparison).||||0.85
72587588|NCT02110758|144705830|OTHER|||||||0.013|||||||Regression, Logistic|||To estimate exposure to the intervention on the Exchanging Information composite score, we used a difference-in-differences model with fixed effects for practices. The dependent variable was the composite score. The intervention effects were represented by the coefficient estimates for survey time period (pre or post) interacted with status (pilot or comparison).||||.013
72587589|NCT02110758|144705830|OTHER|||||||0.053|||||||Regression, Logistic|||To estimate exposure to the intervention on the Overall Rating of Treatment Team composite score, we used a difference-in-differences model with fixed effects for practices. The dependent variable was the composite score. The intervention effects were represented by the coefficient estimates for survey time period (pre or post) interacted with status (pilot or comparison).||||.053
72587590|NCT02110758|144705832|OTHER|||||||0.2|||||||Regression, Logistic|||To estimate exposure to the intervention on Per Member Per Month Hospitalizations, we used a difference-in-differences model with fixed effects for practices. The dependent variable was Per Member Per Month Hospitalizations. The intervention effects were represented by the coefficient estimates for utilization time period (baseline or follow-up) interacted with status (pilot or comparison).||||0.2
72587591|NCT02110758|144705832|OTHER|||||||0.62|||||||Regression, Logistic|||To estimate exposure to the intervention on Per Member Per Month Emergency Department (ED) Visits, we used a difference-in-differences model with fixed effects for practices. The dependent variable was Per Member Per Month ED Visits. The intervention effects were represented by the coefficient estimates for utilization time period (baseline or follow-up) interacted with status (pilot or comparison).||||0.62
72587592|NCT02110758|144705832|OTHER|||||||0.68|||||||Regression, Logistic|||To estimate exposure to the intervention on Per Member Per Month Primary Care Visits, we used a difference-in-differences model with fixed effects for practices. The dependent variable was Per Member Per Month Primary Care Visits. The intervention effects were represented by the coefficient estimates for utilization time period (baseline or follow-up) interacted with status (pilot or comparison).||||0.68
72587593|NCT02110758|144705832|OTHER|||||||0.03|||||||Regression, Logistic|||To estimate exposure to the intervention on Per Member Per Month Specialist Visits, we used a difference-in-differences model with fixed effects for practices. The dependent variable was Per Member Per Month Specialist Visits. The intervention effects were represented by the coefficient estimates for utilization time period (baseline or follow-up) interacted with status (pilot or comparison).||||0.03
72587594|NCT01605552|144705847|SUPERIORITY|||||||0.21|||||||ANCOVA||||Cohen's d = 0.61|||.21
72587595|NCT01605552|144705848|SUPERIORITY|||||||0.019|||||||ANCOVA||||Cohen's d = 1.33|||.019
72587596|NCT01605552|144705849|SUPERIORITY|||||||0.09|||||||ANCOVA||||Cohen's d = 0.78|||.09
72587597|NCT01605552|144705850|SUPERIORITY|||||||0.43|||||||ANCOVA||||Cohen's d = 0.43|||.43
72587598|NCT03018080|144705851|OTHER|Estimation only.|Rate|0.238|||||TWO_SIDED|95.0|0.082|0.472|||||Confidence interval estimated using the Clopper Pearson method.|The reported grade 3/4 toxicity rate with weekly paclitaxel was 0.35. If it became evident that the grade 3/4 treatment-related toxicity rate on either arm convincingly exceeded 0.35, the study arm would have been halted. Convincing evidence of exceeding 0.35 was based on Bayesian methods and continuous monitoring, where the stopping rule would have held enrollment if the posterior probability at any point exceeded 0.50 or higher.||0.472|0.082|
72587599|NCT03018080|144705851|OTHER|Estimation only.|Rate|0.316|||||TWO_SIDED|95.0|0.126|0.566|||||Confidence interval estimated using the Clopper Pearson method.|The reported grade 3/4 toxicity rate with weekly paclitaxel was 0.35. If it became evident that the grade 3/4 treatment-related toxicity rate on either arm convincingly exceeded 0.35, the study arm would have been halted. Convincing evidence of exceeding 0.35 was based on Bayesian methods and continuous monitoring, where the stopping rule would have held enrollment if the posterior probability at any point exceeded 0.50 or higher.||0.566|0.126|
72587600|NCT03018080|144705852|OTHER|Estimation only|Rate|0.191|||||TWO_SIDED|95.0|0.055|0.419|||||Confidence interval estimated using the Clopper Pearson method.|||0.419|0.055|
72587601|NCT03018080|144705852|OTHER|Estimation only.|Rate|0.421|||||TWO_SIDED|95.0|0.203|0.665|||||Confidence interval estimated using the Clopper Pearson method|||0.665|0.203|
72587602|NCT03018080|144705853|OTHER|Estimation only|Median|4.1|||||TWO_SIDED|95.0|1.4|6.9|||||The Kaplan Meier method was used to estimate the median PFS(in months) for the population. The Greenwood method was used to estimate the confidence limits of the median progression free survival.|||6.9|1.4|
72587603|NCT03018080|144705853|OTHER|Estimation only|Median|3.9|||||TWO_SIDED|95.0|1.4|6.8|||||The Kaplan Meier method was used to estimate the median PFS(in months) for the population. The Greenwood method was used to estimate the confidence limits of the median progression free survival.|||6.8|1.4|
72414018|NCT00380068|144337090|SUPERIORITY_OR_OTHER||percent event free|89.4||||||95.0|84.4|92.8|||||Estimate obtained through Kaplan-Meier methods|||92.8|84.4|
72587604|NCT03018080|144705854|OTHER|Estimation only|Median|27.6|||||TWO_SIDED|95.0|9.7||Upper limit of the confidence interval is not reached due to censoring rate||||The Kaplan Meier method was used to estimate median OS (in months). The Greenwood method was used to estimate confidence limits of median overall survival.||||9.7|
72414019|NCT00380068|144337091|SUPERIORITY_OR_OTHER||percent event free|84.1||||||95.0|78.2|88.6|||||Estimate obtained through Kaplan-Meier methods|||88.6|78.2|
72414020|NCT00380068|144337092|SUPERIORITY_OR_OTHER||percent event free|95.3||||||95.0|91.4|97.4|||||Estimate obtained through Kaplan-Meier methods|||97.4|91.4|
72587605|NCT03018080|144705854|OTHER|Estimation only|Median|9.0|||||TWO_SIDED|95.0|6.8|14.0|||||The Kaplan Meier method was used to estimate median OS (in months). The Greenwood method was used to estimate confidence limits of median overall survival.|||14.0|6.8|
72587606|NCT03018080|144705855|OTHER|Estimation only.|Rate|0.667|||||TWO_SIDED|95.0|0.43|0.854|||||Confidence interval estimated using the Clopper Pearson method|||0.854|0.430|
72587607|NCT03018080|144705855|OTHER|Estimation only|Rate|0.632|||||TWO_SIDED|95.0|0.384|0.837|||||Confidence interval estimated using the Clopper Pearson method|||0.837|0.384|
72587608|NCT03018080|144705856|OTHER|Estimation only|Median|7.3|||||TWO_SIDED|95.0|5.6|8.3|||||"The Kaplan Meier method was used to estimate median duration of response (in months).~The Greenwood method was used to estimate confidence limits of median duration of response."|||8.3|5.6|
72587609|NCT03018080|144705856|OTHER|Estimation only|Median|4.0|||||TWO_SIDED|95.0|2.6|8.3|||||"The Kaplan Meier method was used to estimate median duration of response (in months).~The Greenwood method was used to estimate confidence limits of median duration of response."|||8.3|2.6|
72587610|NCT03935425|144705874|SUPERIORITY|||||||0.11|||||||t-test, 2 sided|||||||0.11
72587611|NCT01562782|144705880|EQUIVALENCE|A P value \<0.05 was used to determine no equivalence between groups in the primary outcome- the mean fold change in plasma VLDL triglyceride palmitate, 0-4 hours. A power calculation was based on data obtained in 15 overweight subjects. Assuming a mean absolute difference of 2.7 in South Asians and 1.0 in Caucasians and a standard deviation of 2.0 for both, group sample sizes of 16 and 16 were expected to achieve 80% power to detect a difference of 1.7 using a 2-sided Mann-Whitney test.|Mean Difference (Final Values)|0.61||||0.05|TWO_SIDED||||||Mixed Models Analysis|||The equivalence test was used to compare the fold change in plasma VLDL triglyceride palmitate in Caucasians and South Asians.||||0.05
72587612|NCT01562782|144705881|EQUIVALENCE|A P value \<0.05 was used to determine no equivalence between groups.|||||<|0.05|||||||t-test, 2 sided|||The equivalence test was used to compare 1) the fold change in triglycerides in South Asians and Caucasians and 2) the fold change in VLDL triglycerides in South Asians and Caucasians.||||<0.05
72587613|NCT01562782|144705882|EQUIVALENCE|A P value \<0.05 was used to determine no equivalence between groups.|||||<|0.05|||||||t-test, 2 sided|||The equivalence test is used to compare levels after the sugar beverage of 1) glucose at 1 hour 2) lactate at 1 hour 3) NEFA at 2 hours in South Asians vs Caucasians.||||<0.05
72587614|NCT01562782|144705883|EQUIVALENCE|A P value \<0.05 was used to determine no equivalence between groups.|||||<|0.05|||||||t-test, 2 sided|||||||<0.05
72587615|NCT01562782|144705884|EQUIVALENCE|A P value \<0.05 was used to determine no equivalence between groups.|||||<|0.05|||||||t-test, 2 sided|||||||<0.05
72587616|NCT01562782|144705885|EQUIVALENCE|A P value \<0.05 was used to determine no equivalence between groups.|||||<|0.05|||||||Pearson or Spearman's rank test|||The equivalence test was used to analyze the relationship between the primary outcome, fold change in VLDL TG palmitate, and the listed levels of biomarkers of carbohydrate and fat metabolism. The correlation analysis was performed on data from each study group separately.||||<0.05
72587617|NCT01562782|144705886|EQUIVALENCE|A P value \<0.05 was used to determine no equivalence between groups.|||||<|0.05|||||||t-test, 2 sided|||||||<0.05
72587618|NCT01562782|144705887|EQUIVALENCE|A P value \<0.05 was used to determine no equivalence between groups.|||||<|0.05|||||||t-test, 2 sided|||||||<0.05
72587619|NCT01562782|144705888|EQUIVALENCE|A P value \<0.05 was used to determine no equivalence between groups.|||||<|0.05|||||||t-test, 2 sided|||||||<0.05
72587620|NCT01562782|144705889|EQUIVALENCE|A P value \<0.05 was used to determine no equivalence between groups.|||||<|0.05|||||||t-test, 2 sided|||||||<0.05
72587621|NCT02064816|144705949|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.6|STANDARD_DEVIATION|3.5||0.277763|TWO_SIDED|95.0|-0.46|1.56|||Mann-Whitney Non Parametric test|||||1.56|-0.46|0.277763
72587622|NCT02064816|144705950|SUPERIORITY_OR_OTHER||Least Square (LS) Mean difference|1.3492||||0.0083|TWO_SIDED|95.0|0.3495|2.3489|||linear mixed model for repeated measures|||Week 4||2.3489|0.3495|0.0083
72587623|NCT02064816|144705950|SUPERIORITY_OR_OTHER||LS Mean difference|1.3367||||0.0079|TWO_SIDED|95.0|0.3534|2.32|||linear mixed model for repeated measures|||Week 8||2.3200|0.3534|0.0079
72587624|NCT02064816|144705951|SUPERIORITY_OR_OTHER||LS Mean difference|0.4003||||0.4311|TWO_SIDED|95.0|-0.5992|1.3998|||linear mixed model for repeated measures|||ISRs subscale Week 4||1.3998|-0.5992|0.4311
72587625|NCT02064816|144705951|SUPERIORITY_OR_OTHER||LS Mean difference|0.08479||||0.8635|TWO_SIDED|95.0|-0.885|1.0546|||linear mixed model for repeated measures|||ISRs subscale Week 8||1.0546|-0.8850|0.8635
72587626|NCT02064816|144705951|SUPERIORITY_OR_OTHER||LS Mean difference|-0.3245||||0.5099|TWO_SIDED|95.0|-1.2927|0.6437|||linear mixed model for repeated measures|||ISRs subscale Week 12||0.6437|-1.2927|0.5099
72587627|NCT02064816|144705951|SUPERIORITY_OR_OTHER||LS Mean difference|-0.07079||||0.8574|TWO_SIDED|95.0|-0.8452|0.7036|||linear mixed model for repeated measures|||Global side-effect subscale: Week 4||0.7036|-0.8452|0.8574
72587628|NCT02064816|144705951|SUPERIORITY_OR_OTHER||LS Mean difference|0.1897||||0.6338|TWO_SIDED|95.0|-0.5926|0.972|||linear mixed model for repeated measures|||Global side-effect subscale: Week 8||0.9720|-0.5926|0.6338
72587629|NCT02064816|144705951|SUPERIORITY_OR_OTHER||LS Mean difference|0.4097||||0.3042|TWO_SIDED|95.0|-0.3734|1.1929|||linear mixed model for repeated measures|||Global side-effect subscale: Week 12||1.1929|-0.3734|0.3042
72587630|NCT02064816|144705951|SUPERIORITY_OR_OTHER||LS Mean difference|-0.4083||||0.1038|TWO_SIDED|95.0|-0.9008|0.08419|||linear mixed model for repeated measures|||Benefits: Week 4||0.08419|-0.9008|0.1038
72587631|NCT02064816|144705951|SUPERIORITY_OR_OTHER||LS Mean difference|-0.1358||||0.594|TWO_SIDED|95.0|-0.637|0.3653|||linear mixed model for repeated measures|||Benefits: Week 8||0.3653|-0.6370|0.5940
72587632|NCT02064816|144705951|SUPERIORITY_OR_OTHER||LS Mean difference|-0.05809||||0.8217|TWO_SIDED|95.0|-0.5651|0.4489|||linear mixed model for repeated measures|||Benefits: Week 12||0.4489|-0.5651|0.8217
72587633|NCT02064816|144705951|SUPERIORITY_OR_OTHER||LS Mean difference|0.5909||||0.489|TWO_SIDED|95.0|-1.0873|2.269|||linear mixed model for repeated measures|||Description of pain: Week 4||2.2690|-1.0873|0.4890
72587634|NCT02064816|144705951|SUPERIORITY_OR_OTHER||LS Mean difference|-0.7689||||0.3719|TWO_SIDED|95.0|-2.4607|0.9229|||linear mixed model for repeated measures|||Description of pain: Week 8||0.9229|-2.4607|0.3719
72587635|NCT02064816|144705951|SUPERIORITY_OR_OTHER||LS Mean difference|0.1422||||0.869|TWO_SIDED|95.0|-1.5521|1.8364|||linear mixed model for repeated measures|||Description of pain: Week 12||1.8364|-1.5521|0.8690
72587636|NCT02064816|144705951|SUPERIORITY_OR_OTHER||LS Mean difference|0.6544||||0.8328|TWO_SIDED|95.0|-5.4393|6.7482|||linear mixed model for repeated measures|||VAS: Week 4||6.7482|-5.4393|0.8328
72587637|NCT02064816|144705951|SUPERIORITY_OR_OTHER||LS Mean difference|-2.2294||||0.4764|TWO_SIDED|95.0|-8.38|3.9212|||linear mixed model for repeated measures|||VAS: Week 8||3.9212|-8.3800|0.4764
72587638|NCT02064816|144705951|SUPERIORITY_OR_OTHER||LS Mean difference|-5.4196||||0.0852|TWO_SIDED|95.0|-11.5939|0.7547|||linear mixed model for repeated measures|||VAS: Week 12||0.7547|-11.5939|0.0852
72587639|NCT02064816|144705951|SUPERIORITY_OR_OTHER||LS Mean difference|0.006873||||0.9639|TWO_SIDED|95.0|-0.2918|0.3055|||linear mixed model for repeated measures|||Rating of pain: Week 4||0.3055|-0.2918|0.9639
72587640|NCT02064816|144705951|SUPERIORITY_OR_OTHER||LS Mean difference|-0.08689||||0.5715|TWO_SIDED|95.0|-0.3886|0.2148|||linear mixed model for repeated measures|||Rating of pain: Week 8||0.2148|-0.3886|0.5715
72587641|NCT02064816|144705951|SUPERIORITY_OR_OTHER||LS Mean difference|-0.2224||||0.1502|TWO_SIDED|95.0|-0.5256|0.0809|||linear mixed model for repeated measures|||Rating of pain: Week 12||0.08090|-0.5256|0.1502
72587642|NCT01732458|144706011|SUPERIORITY_OR_OTHER||Difference in Percentage vs. Ondansetron|-16.5|||||TWO_SIDED|95.0|-34.0|2.0||||||The Miettinen and Nurminen method was used to provide 95% confidence intervals (CIs) for between-treatment differences in the percentage of participants with events.||2.0|-34.0|
72587643|NCT01732458|144706011|SUPERIORITY_OR_OTHER||Difference in Percentage vs. Ondansetron|-4.4|||||TWO_SIDED|95.0|-22.9|14.3||||||The Miettinen and Nurminen method was used to provide 95% confidence intervals (CIs) for between-treatment differences in the percentage of participants with events.||14.3|-22.9|
72414021|NCT00380068|144337093|SUPERIORITY_OR_OTHER||percent event free|92.9||||||95.0|88.3|95.8|||||Estimate obtained through Kaplan-Meier methods|||95.8|88.3|
72587644|NCT01732458|144706011|SUPERIORITY_OR_OTHER||Difference in Percentage vs. Ondansetron|-12.4|||||TWO_SIDED|95.0|-30.3|6.3||||||The Miettinen and Nurminen method was used to provide 95% confidence intervals (CIs) for between-treatment differences in the percentage of participants with events.||6.3|-30.3|
72587645|NCT00570063|144706052|SUPERIORITY_OR_OTHER||Least square (LS) mean difference|-1.61|STANDARD_ERROR_OF_MEAN|8.94||0.86|TWO_SIDED|90.0|-16.49|13.27|||Mixed Models Analysis|||P-value and 90 percent confidence interval (CI) were obtained from mixed effects repeated measures analysis using covariance structures spatial power covariance structure (SP\[POW\]) with participant as random effect, treatment, visit, and visit-by-treatment interaction as fixed effects and baseline score as a covariate.||13.27|-16.49|0.86
72587646|NCT00570063|144706053|SUPERIORITY_OR_OTHER||LS mean difference|-1.23|STANDARD_ERROR_OF_MEAN|2.69||0.65|TWO_SIDED|90.0|-5.71|3.24|||Mixed Models Analysis|||P-value and 90 percent CI were obtained from mixed effects repeated measures analysis using covariance structures (SP\[POW\]) with participant as random effect, treatment, visit, and visit-by-treatment interaction as fixed effects and baseline score as a covariate.||3.24|-5.71|0.65
72587647|NCT00570063|144706054|SUPERIORITY_OR_OTHER||LS mean difference|-0.24|STANDARD_ERROR_OF_MEAN|2.61||0.93|TWO_SIDED|90.0|-4.59|4.1|||Mixed Models Analysis|||P-value and 90 percent CI were obtained from mixed effects repeated measures analysis using covariance structures (SP\[POW\]) with participant as random effect, treatment, visit, and visit-by-treatment interaction as fixed effects and baseline score as a covariate.||4.10|-4.59|0.93
72587648|NCT00570063|144706055|SUPERIORITY_OR_OTHER||LS mean difference|0.74|STANDARD_ERROR_OF_MEAN|4.18||0.86|TWO_SIDED|90.0|-6.21|7.69|||Mixed Models Analysis|||P-value and 90 percent CI were obtained from mixed effects repeated measures analysis using covariance structures (SP\[POW\]) with participant as random effect, treatment, visit, and visit-by-treatment interaction as fixed effects and baseline score as a covariate.||7.69|-6.21|0.86
72587649|NCT00570063|144706056|SUPERIORITY_OR_OTHER||LS mean difference|-2.57|STANDARD_ERROR_OF_MEAN|3.22||0.43|TWO_SIDED|90.0|-7.92|2.79|||Mixed Models Analysis|||P-value and 90 percent CI were obtained from mixed effects repeated measures analysis using covariance structures (SP\[POW\]) with participant as random effect, treatment, visit, and visit-by-treatment interaction as fixed effects and baseline score as a covariate.||2.79|-7.92|0.43
72587650|NCT00570063|144706057|SUPERIORITY_OR_OTHER||LS mean difference|-0.3|STANDARD_ERROR_OF_MEAN|2.68||0.91|TWO_SIDED|90.0|-4.76|4.16|||Mixed Models Analysis|||P-value and 90 percent CI were obtained from mixed effects repeated measures analysis using covariance structures (SP\[POW\]) with participant as random effect, treatment, visit, and visit-by-treatment interaction as fixed effects and baseline score as a covariate.||4.16|-4.76|0.91
72587651|NCT00570063|144706058|SUPERIORITY_OR_OTHER||LS mean difference|0.63|STANDARD_ERROR_OF_MEAN|2.29||0.78|TWO_SIDED|90.0|-3.17|4.43|||Mixed Models Analysis|||P-value and 90 percent CI were obtained from mixed effects repeated measures analysis using covariance structures (SP\[POW\]) with participant as random effect, treatment, visit, and visit-by-treatment interaction as fixed effects and baseline score as a covariate.||4.43|-3.17|0.78
72587652|NCT00570063|144706059|SUPERIORITY_OR_OTHER||LS mean difference|0.14|STANDARD_ERROR_OF_MEAN|1.35||0.92|TWO_SIDED|90.0|-2.11|2.39|||Mixed Models Analysis|||P-value and 90 percent CI were obtained from mixed effects repeated measures analysis using covariance structures (SP\[POW\]) with participant as random effect, treatment, visit, and visit-by-treatment interaction as fixed effects and baseline score as a covariate.||2.39|-2.11|0.92
72587653|NCT00570063|144706060|SUPERIORITY_OR_OTHER||LS mean difference|0.84|STANDARD_ERROR_OF_MEAN|1.62||0.6|TWO_SIDED|90.0|-1.85|3.54|||Mixed Models Analysis|||P-value and 90 percent CI were obtained from mixed effects repeated measures analysis using covariance structures (SP\[POW\]) with participant as random effect, treatment, visit, and visit-by-treatment interaction as fixed effects and baseline score as a covariate.||3.54|-1.85|0.60
72414022|NCT00380068|144337094|SUPERIORITY_OR_OTHER||percent event free|95.0||||||95.0|88.5|97.9|||||Estimate obtained through Kaplan-Meier methods|||97.9|88.5|
72414023|NCT00380068|144337095|SUPERIORITY_OR_OTHER||percent event free|90.0||||||95.0|81.6|94.7|||||Estimate obtained through Kaplan-Meier methods|||94.7|81.6|
72587654|NCT00570063|144706061|SUPERIORITY_OR_OTHER||LS mean difference|0.44|STANDARD_ERROR_OF_MEAN|1.86||0.81|TWO_SIDED|90.0|-2.65|3.53|||Mixed Models Analysis|||P-value and 90 percent CI were obtained from mixed effects repeated measures analysis using covariance structures (SP\[POW\]) with participant as random effect, treatment, visit, and visit-by-treatment interaction as fixed effects and baseline score as a covariate.||3.53|-2.65|0.81
72587655|NCT00570063|144706062|SUPERIORITY_OR_OTHER||LS mean difference|-0.04|STANDARD_ERROR_OF_MEAN|0.48||0.93|TWO_SIDED|90.0|-0.84|0.76|||Mixed Models Analysis|||P-value and 90 percent CI were obtained from mixed effects repeated measures analysis using covariance structures (SP\[POW\]) with participant as random effect, treatment, visit, and visit-by-treatment interaction as fixed effects and baseline score as a covariate.||0.76|-0.84|0.93
72587656|NCT00570063|144706063|SUPERIORITY_OR_OTHER||LS mean difference|0.01|STANDARD_ERROR_OF_MEAN|0.68||0.99|TWO_SIDED|90.0|-1.13|1.14|||Mixed Models Analysis|||P-value and 90 percent CI were obtained from mixed effects repeated measures analysis using covariance structures (SP\[POW\]) with participant as random effect, treatment, visit, and visit-by-treatment interaction as fixed effects.||1.14|-1.13|0.99
72587657|NCT00570063|144706064|SUPERIORITY_OR_OTHER||Median Difference (Net)|-0.158|STANDARD_DEVIATION|0.844|||TWO_SIDED|90.0|-1.546|1.231||||||Change at Day 21: Cried||1.231|-1.546|
72587658|NCT00570063|144706064|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.444|STANDARD_DEVIATION|1.078|||TWO_SIDED|90.0|-1.329|2.218||||||Change at Day 21: Felt blue or depressed||2.218|-1.329|
72587659|NCT00570063|144706064|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.544|STANDARD_DEVIATION|4.32|||TWO_SIDED|90.0|-5.561|8.649||||||Change at Day 21: Irritability||8.649|-5.561|
72587660|NCT00570063|144706064|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.573|STANDARD_DEVIATION|2.955|||TWO_SIDED|90.0|-4.287|5.433||||||Change at Day 21: Manifest psychosis||5.433|-4.287|
72587661|NCT00570063|144706064|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.556|STANDARD_DEVIATION|2.096|||TWO_SIDED|90.0|-2.892|4.003||||||Change at Day 21: Personal neatness||4.003|-2.892|
72587662|NCT00570063|144706064|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.327|STANDARD_DEVIATION|0.532|||TWO_SIDED|90.0|-1.202|0.547||||||Change at Day 21: Refused to speak||0.547|-1.202|
72587663|NCT00570063|144706064|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.632|STANDARD_DEVIATION|2.749|||TWO_SIDED|90.0|-5.152|3.889||||||Change at Day 21: Retardation||3.889|-5.152|
72587664|NCT00570063|144706064|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.17|STANDARD_DEVIATION|0.572|||TWO_SIDED|90.0|-1.11|0.771||||||Change at Day 21: Said he/she was no good||0.771|-1.110|
72587665|NCT00570063|144706064|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.561|STANDARD_DEVIATION|2.63|||TWO_SIDED|90.0|-4.887|3.764||||||Change at Day 21: Social competence||3.764|-4.887|
72587666|NCT00570063|144706064|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.62|STANDARD_DEVIATION|4.447|||TWO_SIDED|90.0|-7.934|6.694||||||Change at Day 21: Social interest||6.694|-7.934|
72587667|NCT00570063|144706065|SUPERIORITY_OR_OTHER||Mean Difference (Net)|5.712|STANDARD_DEVIATION|12.24|||TWO_SIDED|90.0|-14.42|25.845||||||||25.845|-14.42|
72587668|NCT00570063|144706075|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.849|STANDARD_DEVIATION|4.23|||TWO_SIDED|90.0|-7.807|6.109||||||||6.109|-7.807|
72587669|NCT00570063|144706076|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.195|STANDARD_DEVIATION|9.307|||TWO_SIDED|90.0|-19.5|11.114||||||||11.114|-19.50|
72587670|NCT00570063|144706077|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.273|STANDARD_DEVIATION|3.488|||TWO_SIDED|90.0|-6.01|5.465||||||Change at Day 21: Parkinsonism||5.465|-6.010|
72587671|NCT00570063|144706077|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.182|STANDARD_DEVIATION|3.008|||TWO_SIDED|90.0|-5.13|4.766||||||Change at Day 21: Dyskinesia||4.766|-5.130|
72587672|NCT00570063|144706077|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.932|STANDARD_DEVIATION|1.425|||TWO_SIDED|90.0|-3.275|1.411||||||Change at Day 21: Dystonia||1.411|-3.275|
72587673|NCT00570063|144706077|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.705|STANDARD_DEVIATION|1.652|||TWO_SIDED|90.0|-2.013|3.422||||||Change at Day 21: Akathisia||3.422|-2.013|
72587674|NCT00570063|144706078|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.291|STANDARD_DEVIATION|1.203|||TWO_SIDED|90.0|-2.27|1.688||||||Change at Day 4||1.688|-2.270|
72587675|NCT00570063|144706078|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.327|STANDARD_DEVIATION|1.349|||TWO_SIDED|90.0|-1.892|2.547||||||Change at Day 7||2.547|-1.892|
72587676|NCT00570063|144706078|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.436|STANDARD_DEVIATION|1.448|||TWO_SIDED|90.0|-1.946|2.817||||||Change at Day 14||2.817|-1.946|
72587677|NCT00570063|144706078|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.1|STANDARD_DEVIATION|1.133|||TWO_SIDED|90.0|-1.763|1.963||||||Change at Day 21||1.963|-1.763|
72587678|NCT03307252|144706083|OTHER||Adjusted geometric mean (gMean) ratio|100.7|STANDARD_ERROR_OF_MEAN|17.9|||TWO_SIDED|90.0|88.84|114.15|||ANOVA||Standard Error of the mean is actually intra individual geometric coefficient of variation (gCV). Adjusted gMean ratio is given for T1 vs. R1.||Digoxin, Analysis of variance (ANOVA) model on the logarithmic scale includes effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|114.15|88.84|
72587679|NCT03307252|144706083|OTHER||Adjusted gMean ratio|93.76|STANDARD_ERROR_OF_MEAN|12.1|||TWO_SIDED|90.0|86.12|102.06|||ANOVA||Standard Error of the mean is actually intra individual geometric coefficient of variation (gCV). Adjusted gMean ratio is given for T1 vs. R1.||Furosemide, ANOVA model on the logarithmic scale includes effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|102.06|86.12|
72587680|NCT03307252|144706083|OTHER||Adjusted gMean Ratio|82.97|STANDARD_ERROR_OF_MEAN|10.7|||TWO_SIDED|90.0|76.96|89.46|||ANOVA||Standard Error of the mean is actually intra individual geometric coefficient of variation (gCV). Adjusted gMean ratio is given for T1 vs. R1.||Metformin, ANOVA model on the logarithmic scale includes effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|89.46|76.96|
72587681|NCT03307252|144706083|OTHER||Adjusted gMean Ratio|113.4|STANDARD_ERROR_OF_MEAN|21.5|||TWO_SIDED|90.0|97.62|131.72|||ANOVA||Standard Error of the mean is actually intra individual geometric coefficient of variation (gCV). Adjusted gMean ratio is given for T1 vs. R1.||Rosuvastatin, ANOVA model on the logarithmic scale includes effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|131.72|97.62|
72587682|NCT03307252|144706084|OTHER||Adjusted geometric mean (gMean) ratio|131.41|STANDARD_ERROR_OF_MEAN|17.9|||TWO_SIDED|90.0|115.93|148.97|||ANOVA||Standard Error of the mean is actually intra individual geometric coefficient of variation (gCV). Adjusted gMean ratio is given for T2 vs. R1.||Digoxin, Analysis of variance (ANOVA) model on the logarithmic scale includes effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|148.97|115.93|
72587683|NCT03307252|144706084|OTHER||Adjusted gMean ratio|119.78|STANDARD_ERROR_OF_MEAN|12.1|||TWO_SIDED|90.0|110.03|130.39|||ANOVA||Standard Error of the mean is actually intra individual geometric coefficient of variation (gCV). Adjusted gMean ratio is given for T2 vs. R1.||Furosemide, ANOVA model on the logarithmic scale includes effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|130.39|110.03|
72587684|NCT03307252|144706084|OTHER||Adjusted gMean Ratio|108.55|STANDARD_ERROR_OF_MEAN|10.7|||TWO_SIDED|90.0|100.68|117.03|||ANOVA||Standard Error of the mean is actually intra individual geometric coefficient of variation (gCV). Adjusted gMean ratio is given for T2 vs. R1.||Metformin, ANOVA model on the logarithmic scale includes effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|117.03|100.68|
72587685|NCT03307252|144706084|OTHER||Adjusted gMean Ratio|348.06|STANDARD_ERROR_OF_MEAN|21.5|||TWO_SIDED|90.0|299.64|404.31|||ANOVA||Standard Error of the mean is actually intra individual geometric coefficient of variation (gCV). Adjusted gMean ratio is given for T2 vs. R1.||Rosuvastatin, ANOVA model on the logarithmic scale includes effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|404.31|299.64|
72587686|NCT03307252|144706085|OTHER||Adjusted geometric mean (gMean) ratio|125.61|STANDARD_ERROR_OF_MEAN|13.2|||TWO_SIDED|90.0|113.99|138.43|||ANOVA||Standard Error of the mean is actually intra individual geometric coefficient of variation (gCV). Adjusted gMean ratio is given for T3 vs. R1.||Digoxin, Analysis of variance (ANOVA) model on the logarithmic scale includes effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|138.43|113.99|
72587687|NCT03307252|144706085|OTHER||Adjusted gMean ratio|101.21|STANDARD_ERROR_OF_MEAN|9.2|||TWO_SIDED|90.0|94.59|108.3|||ANOVA||Standard Error of the mean is actually intra individual geometric coefficient of variation (gCV). Adjusted gMean ratio is given for T3 vs. R1.||Furosemide, ANOVA model on the logarithmic scale includes effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|108.30|94.59|
72587688|NCT03307252|144706085|OTHER||Adjusted gMean Ratio|130.94|STANDARD_ERROR_OF_MEAN|13.6|||TWO_SIDED|90.0|119.82|143.1|||ANOVA||Standard Error of the mean is actually intra individual geometric coefficient of variation (gCV). Adjusted gMean ratio is given for T3 vs. R1.||Metformin, ANOVA model on the logarithmic scale includes effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|143.10|119.82|
72414024|NCT00380068|144337096|SUPERIORITY_OR_OTHER||percent event free|97.1||||||95.0|93.6|98.7|||||Estimate obtained through Kaplan-Meier methods|||98.7|93.6|
72414025|NCT00380068|144337097|SUPERIORITY_OR_OTHER||percent event free|95.3||||||95.0|91.2|97.6|||||Estimate obtained through Kaplan-Meier methods|||97.6|91.2|
72587689|NCT03307252|144706085|OTHER||Adjusted gMean Ratio|107.42|STANDARD_ERROR_OF_MEAN|12.9|||TWO_SIDED|90.0|97.57|118.27|||ANOVA||Standard Error of the mean is actually intra individual geometric coefficient of variation (gCV). Adjusted gMean ratio is given for T3 vs. R1.||Rosuvastatin, ANOVA model on the logarithmic scale includes effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|118.27|97.57|
72587690|NCT03307252|144706086|OTHER||Adjusted geometric mean (gMean) ratio|106.78|STANDARD_ERROR_OF_MEAN|15.5|||TWO_SIDED|90.0|96.51|118.15|||ANOVA||Standard Error of the mean is actually intra individual geometric coefficient of variation (gCV). Adjusted gMean ratio is given for T4 vs. R1.||Digoxin, Analysis of variance (ANOVA) model on the logarithmic scale includes effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|118.15|96.51|
72587691|NCT03307252|144706086|OTHER||Adjusted gMean ratio|271.63|STANDARD_ERROR_OF_MEAN|15.9|||TWO_SIDED|90.0|246.74|299.03|||ANOVA||Standard Error of the mean is actually intra individual geometric coefficient of variation (gCV). Adjusted gMean ratio is given for T4 vs. R1.||Furosemide, ANOVA model on the logarithmic scale includes effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|299.03|246.74|
72414026|NCT01297062|144337098|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is established if the upper limit of 2-sided 90% confidence interval (CI), equivalent to the upper limit of 1-sided 95% CI, for change from baseline in QTcP (exenatide - placebo) is below 10 msec.|Least Squares Mean Difference|-1.36|||||TWO_SIDED|90.0|-2.21|-0.5||No adjustment on CI for the primary outcome measure.|Mixed Models Analysis||The MMRM includes Treatment (Exenatide versus Placebo), Day, Time, Period, Sequence, and Day-Time-Treatment interaction as fixed effects, subject random intercept.|60 evaluable subjects gives more than 90% power to show non-inferiority of exenatide versus placebo, using t-test in 2-way crossover, alpha=0.05, true difference of 5 msec, and standard deviation of the within-subject difference of 10.04 msec.||-0.50|-2.21|
72587692|NCT03307252|144706086|OTHER||Adjusted gMean Ratio|100.8|STANDARD_ERROR_OF_MEAN|9.6|||TWO_SIDED|90.0|94.62|107.39|||ANOVA||Standard Error of the mean is actually intra individual geometric coefficient of variation (gCV). Adjusted gMean ratio is given for T4 vs. R1.||Metformin, ANOVA model on the logarithmic scale includes effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|107.39|94.62|
72587693|NCT03307252|144706086|OTHER||Adjusted gMean Ratio|223.24|STANDARD_ERROR_OF_MEAN|13.9|||TWO_SIDED|90.0|203.79|244.55|||ANOVA||Standard Error of the mean is actually intra individual geometric coefficient of variation (gCV). Adjusted gMean ratio is given for T4 vs. R1.||Rosuvastatin, ANOVA model on the logarithmic scale includes effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|244.55|203.79|
72587694|NCT03307252|144706087|OTHER||Adjusted geometric mean (gMean) ratio|121.64|STANDARD_ERROR_OF_MEAN|27.7|||TWO_SIDED|90.0|100.43|147.33|||ANOVA||Standard Error of the mean is actually intra individual geometric coefficient of variation (gCV). Adjusted gMean ratio is given for T1 vs. R1.||Digoxin, Analysis of variance (ANOVA) model on the logarithmic scale includes effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|147.33|100.43|
72587695|NCT03307252|144706087|OTHER||Adjusted gMean ratio|95.18|STANDARD_ERROR_OF_MEAN|19.6|||TWO_SIDED|90.0|83.03|109.11|||ANOVA||Standard Error of the mean is actually intra individual geometric coefficient of variation (gCV). Adjusted gMean ratio is given for T1 vs. R1.||Furosemide, ANOVA model on the logarithmic scale includes effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|109.11|83.03|
72587696|NCT03307252|144706087|OTHER||Adjusted gMean Ratio|80.19|STANDARD_ERROR_OF_MEAN|13.4|||TWO_SIDED|90.0|73.01|88.08|||ANOVA||Standard Error of the mean is actually intra individual geometric coefficient of variation (gCV). Adjusted gMean ratio is given for T1 vs. R1.||Metformin, ANOVA model on the logarithmic scale includes effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|88.08|73.01|
72587697|NCT03307252|144706087|OTHER||Adjusted gMean Ratio|115.39|STANDARD_ERROR_OF_MEAN|30.1|||TWO_SIDED|90.0|93.8|141.94|||ANOVA||Standard Error of the mean is actually intra individual geometric coefficient of variation (gCV). Adjusted gMean ratio is given for T1 vs. R1.||Rosuvastatin, ANOVA model on the logarithmic scale includes effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|141.94|93.80|
72421549|NCT01181726|144354232|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|97.72|||||TWO_SIDED|90.0|94.03|101.56|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||101.56|94.03|
72587698|NCT03307252|144706088|OTHER||Adjusted geometric mean (gMean) ratio|218.26|STANDARD_ERROR_OF_MEAN|27.7|||TWO_SIDED|90.0|180.19|264.36|||ANOVA||Standard Error of the mean is actually intra individual geometric coefficient of variation (gCV). Adjusted gMean ratio is given for T2 vs. R1.||Digoxin, Analysis of variance (ANOVA) model on the logarithmic scale includes effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|264.36|180.19|
72587699|NCT03307252|144706088|OTHER||Adjusted gMean ratio|135.07|STANDARD_ERROR_OF_MEAN|19.6|||TWO_SIDED|90.0|117.83|154.84|||ANOVA||Standard Error of the mean is actually intra individual geometric coefficient of variation (gCV). Adjusted gMean ratio is given for T2 vs. R1.||Furosemide, ANOVA model on the logarithmic scale includes effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|154.84|117.83|
72587700|NCT03307252|144706088|OTHER||Adjusted gMean Ratio|112.31|STANDARD_ERROR_OF_MEAN|13.4|||TWO_SIDED|90.0|102.26|123.35|||ANOVA||Standard Error of the mean is actually intra individual geometric coefficient of variation (gCV). Adjusted gMean ratio is given for T2 vs. R1.||Metformin, ANOVA model on the logarithmic scale includes effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|123.35|102.26|
72587701|NCT03307252|144706088|OTHER||Adjusted gMean Ratio|1125.1|STANDARD_ERROR_OF_MEAN|30.1|||TWO_SIDED|90.0|914.63|1384.0|||ANOVA||Standard Error of the mean is actually intra individual geometric coefficient of variation (gCV). Adjusted gMean ratio is given for T2 vs. R1.||Rosuvastatin, ANOVA model on the logarithmic scale includes effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|1384.00|914.63|
72587702|NCT03307252|144706089|OTHER||Adjusted geometric mean (gMean) ratio|218.26|STANDARD_ERROR_OF_MEAN|27.7|||TWO_SIDED|90.0|180.19|264.36|||ANOVA||Standard Error of the mean is actually intra individual geometric coefficient of variation (gCV). Adjusted gMean ratio is given for T3 vs. R1.||Digoxin, Analysis of variance (ANOVA) model on the logarithmic scale includes effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|264.36|180.19|
72587703|NCT03307252|144706089|OTHER||Adjusted gMean ratio|104.78|STANDARD_ERROR_OF_MEAN|21.0|||TWO_SIDED|90.0|89.97|122.03|||ANOVA||Standard Error of the mean is actually intra individual geometric coefficient of variation (gCV). Adjusted gMean ratio is given for T3 vs. R1.||Furosemide, ANOVA model on the logarithmic scale includes effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|122.03|89.97|
72587704|NCT03307252|144706089|OTHER||Adjusted gMean Ratio|122.65|STANDARD_ERROR_OF_MEAN|20.1|||TWO_SIDED|90.0|107.68|139.69|||ANOVA||Standard Error of the mean is actually intra individual geometric coefficient of variation (gCV). Adjusted gMean ratio is given for T4 vs. R1.||Metformin, ANOVA model on the logarithmic scale includes effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|139.69|107.68|
72587705|NCT03307252|144706089|OTHER||Adjusted gMean Ratio|116.88|STANDARD_ERROR_OF_MEAN|14.4|||TWO_SIDED|90.0|105.07|130.03|||ANOVA||Standard Error of the mean is actually intra individual geometric coefficient of variation (gCV). Adjusted gMean ratio is given for T3 vs. R1.||Rosuvastatin, ANOVA model on the logarithmic scale includes effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|130.03|105.07|
72587706|NCT03307252|144706090|OTHER||Adjusted geometric mean (gMean) ratio|87.07|STANDARD_ERROR_OF_MEAN|20.9|||TWO_SIDED|90.0|76.08|99.64|||ANOVA||Standard Error of the mean is actually intra individual geometric coefficient of variation (gCV). Adjusted gMean ratio is given for T4 vs. R1.||Digoxin, Analysis of variance (ANOVA) model on the logarithmic scale includes effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|99.64|76.08|
72587707|NCT03307252|144706090|OTHER||Adjusted gMean ratio|122.94|STANDARD_ERROR_OF_MEAN|18.0|||TWO_SIDED|90.0|110.25|137.09|||ANOVA||Standard Error of the mean is actually intra individual geometric coefficient of variation (gCV). Adjusted gMean ratio is given for T4 vs. R1.||Furosemide, ANOVA model on the logarithmic scale includes effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|137.09|110.25|
72587708|NCT03307252|144706090|OTHER||Adjusted gMean Ratio|101.35|STANDARD_ERROR_OF_MEAN|12.0|||TWO_SIDED|90.0|93.65|109.7|||ANOVA||Standard Error of the mean is actually intra individual geometric coefficient of variation (gCV). Adjusted gMean ratio is given for T4 vs. R1.||Metformin, ANOVA model on the logarithmic scale includes effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|109.70|93.65|
72587709|NCT03307252|144706090|OTHER||Adjusted gMean Ratio|428.23|STANDARD_ERROR_OF_MEAN|26.8|||TWO_SIDED|90.0|359.78|509.7|||ANOVA||Standard Error of the mean is actually intra individual geometric coefficient of variation (gCV). Adjusted gMean ratio is given for T4 vs. R1.||Rosuvastatin, ANOVA model on the logarithmic scale includes effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|509.70|359.78|
72587710|NCT03307252|144706091|OTHER||Adjusted gMean ratio|92.24|STANDARD_ERROR_OF_MEAN|11.2|||TWO_SIDED|90.0|85.28|99.76|||ANOVA||Standard Error of the mean is actually intra individual geometric coefficient of variation (gCV). Adjusted gMean ratio is given for T1 vs. R1.||Furosemide, ANOVA model on the logarithmic scale includes effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|99.76|85.28|
72587711|NCT03307252|144706091|OTHER||Adjusted gMean Ratio|83.99|STANDARD_ERROR_OF_MEAN|10.0|||TWO_SIDED|90.0|78.32|90.08|||ANOVA||Standard Error of the mean is actually intra individual geometric coefficient of variation (gCV). Adjusted gMean ratio is given for T1 vs. R1.||Metformin, ANOVA model on the logarithmic scale includes effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|90.08|78.32|
72587712|NCT03307252|144706091|OTHER||Adjusted gMean Ratio|124.06|STANDARD_ERROR_OF_MEAN|23.9|||TWO_SIDED|90.0|105.11|146.43|||ANOVA||Standard Error of the mean is actually intra individual geometric coefficient of variation (gCV). Adjusted gMean ratio is given for T1 vs. R1.||Rosuvastatin, ANOVA model on the logarithmic scale includes effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|146.43|105.11|
72587713|NCT03307252|144706092|OTHER||Adjusted gMean Ratio|112.73|STANDARD_ERROR_OF_MEAN|11.2|||TWO_SIDED|90.0|104.23|121.92|||ANOVA||Standard Error of the mean is actually intra individual geometric coefficient of variation (gCV). Adjusted gMean ratio is given for T2 vs. R1.||Furosemide, ANOVA model on the logarithmic scale includes effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|121.92|104.23|
72587714|NCT03307252|144706092|OTHER||Adjusted gMean Ratio|108.56|STANDARD_ERROR_OF_MEAN|10.0|||TWO_SIDED|90.0|101.22|116.43|||ANOVA||Standard Error of the mean is actually intra individual geometric coefficient of variation (gCV). Adjusted gMean ratio is given for T2 vs. R1.||Metformin, ANOVA model on the logarithmic scale includes effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|116.43|101.22|
72587715|NCT03307252|144706092|OTHER||Adjusted gMean Ratio|340.67|STANDARD_ERROR_OF_MEAN|23.9|||TWO_SIDED|90.0|288.63|402.1|||ANOVA||Standard Error of the mean is actually intra individual geometric coefficient of variation (gCV). Adjusted gMean ratio is given for T2 vs. R1.||Rosuvastatin, ANOVA model on the logarithmic scale includes effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|402.10|288.63|
72552341|NCT04239872|144635442|SUPERIORITY||Mean Difference (Net)|0.8946|||<|0.0001|TWO_SIDED|95.0|0.6671|1.122||The threshold for statistical significance was set at p=0.05.|t-test, 2 sided|Paired t-test was used; there were 17 pairs of data, DF=16|Treatment difference of transformed (log10) data = Calcium mouthwash before fluoride mouthwash - Fluoride mouthwash|A paired t-test was used to compare the two groups. To obtain normal distribution, data used in the statistical analysis were transformed to the log10.||1.122|0.6671|<0.0001
72552342|NCT04239872|144635443|SUPERIORITY||Mean Difference (Net)|0.973|||<|0.0001|TWO_SIDED|95.0|0.7597|1.186||The threshold for statistical significance was set at p=0.05.|t-test, 2 sided|Paired t-test was used; there were 18 pairs of data, DF=17|Treatment difference of transformed (log10) data = Calcium mouthwash before fluoride mouthwash - Fluoride mouthwash|A paired t-test was used to compare the two groups. To obtain normal distribution, data used in the statistical analysis were transformed to the log10.||1.186|0.7597|<0.0001
72552343|NCT04239872|144635444|SUPERIORITY||Mean Difference (Net)|0.9827|||<|0.0001|TWO_SIDED|95.0|0.7758|1.19||The threshold for statistical significance was set at p=0.05.|t-test, 2 sided|Paired t-test was used; there were 18 pairs of data, DF=17|Treatment difference of transformed (log10) data = Calcium mouthwash before fluoride mouthwash - Fluoride mouthwash|A paired t-test was used to compare the two groups. To obtain normal distribution, data used in the statistical analysis were transformed to the log10.||1.19|0.7758|<0.0001
72552344|NCT04239872|144635445|SUPERIORITY||Mean Difference (Net)|0.9181|||<|0.0001|TWO_SIDED|95.0|0.6573|1.179||The threshold for statistical significance was set at p=0.05.|t-test, 2 sided|Paired t-test was used; there were 19 pairs of data, DF=18|Treatment difference of transformed (log10) data = Calcium mouthwash before fluoride mouthwash - Fluoride mouthwash|A paired t-test was used to compare the two groups. To obtain normal distribution, data used in the statistical analysis were transformed to the log10.||1.179|0.6573|<0.0001
72552345|NCT04239872|144635450|SUPERIORITY||Mean Difference (Net)|-0.05652||||0.3283|TWO_SIDED|95.0|-0.1762|0.06829||The threshold for statistical significance was set at p=0.05.|t-test, 2 sided|Paired t-test was used; there were 15 pairs of data, DF=14|Treatment difference of transformed (log10) data = Calcium mouthwash before fluoride mouthwash - Fluoride mouthwash|A paired t-test was used to compare the two groups. To obtain normal distribution, data used in the statistical analysis were transformed to the log10.||0.06829|-0.1762|0.3283
72552346|NCT04239872|144635451|SUPERIORITY||Mean Difference (Net)|0.3411||||0.0058|TWO_SIDED|95.0|0.1189|0.5633||The threshold for statistical significance was set at p=0.05.|t-test, 2 sided|Paired t-test was used; there were 13 pairs of data, DF=12|Treatment difference of transformed (log10) data = Calcium mouthwash before fluoride mouthwash - Fluoride mouthwash|A paired t-test was used to compare the two groups. To obtain normal distribution, data used in the statistical analysis were transformed to the log10.||0.5633|0.1189|0.0058
72552347|NCT04239872|144635452|SUPERIORITY||Mean Difference (Net)|0.2976||||0.0213|TWO_SIDED|95.0|0.05266|0.5426||The threshold for statistical significance was set at p=0.05.|t-test, 2 sided|Paired t-test was used; there were 13 pairs of data, DF=12|Treatment difference of transformed (log10) data = Calcium mouthwash before fluoride mouthwash - Fluoride mouthwash|A paired t-test was used to compare the two groups. To obtain normal distribution, data used in the statistical analysis were transformed to the log10.||0.5426|0.05266|0.0213
72552348|NCT04239872|144635453|SUPERIORITY||Mean Difference (Net)|0.312||||0.014|TWO_SIDED|95.0|0.07454|0.5495||The threshold for statistical significance was set at p=0.05.|t-test, 2 sided|Paired t-test was used; there were 14 pairs of data, DF=13|Treatment difference of transformed (log10) data = Calcium mouthwash before fluoride mouthwash - Fluoride mouthwash|A paired t-test was used to compare the two groups. To obtain normal distribution, data used in the statistical analysis were transformed to the log10.||0.5495|0.07454|0.014
72552349|NCT04239872|144635454|SUPERIORITY||Mean Difference (Net)|0.2524||||0.1393|TWO_SIDED|95.0|-0.09153|0.5962||The threshold for statistical significance was set at p=0.05.|t-test, 2 sided|Paired t-test was used; there were 17 pairs of data, DF=16|Treatment difference = Calcium mouthwash before fluoride mouthwash - Fluoride mouthwash|A paired t-test was used to compare the two groups.||0.5962|-0.09153|0.1393
72552350|NCT04239872|144635455|SUPERIORITY||Mean Difference (Net)|0.2921||||0.0009|TWO_SIDED|95.0|0.1414|0.4427||The threshold for statistical significance was set at p=0.05.|t-test, 2 sided|Paired t-test was used; there were 16 pairs of data, DF=15|Treatment difference of transformed (log10) data = Calcium mouthwash before fluoride mouthwash - Fluoride mouthwash|A paired t-test was used to compare the two groups. To obtain normal distribution, data used in the statistical analysis were transformed to the log10.||0.4427|0.1414|0.0009
72552351|NCT04239872|144635456|SUPERIORITY||Mean Difference (Net)|0.2433||||0.0008|TWO_SIDED|95.0|0.1195|0.3671||The threshold for statistical significance was set at p=0.05.|t-test, 2 sided|Paired t-test was used; there were 16 pairs of data, DF=15|Treatment difference of transformed (log10) data = Calcium mouthwash before fluoride mouthwash - Fluoride mouthwash|A paired t-test was used to compare the two groups. To obtain normal distribution, data used in the statistical analysis were transformed to the log10.||0.3671|0.1195|0.0008
72414027|NCT01297062|144337099|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is established if the upper limit of 2-sided 90% CI, equivalent to the upper limit of 1-sided 95% CI, for change from baseline in QTcP (exenatide - placebo) is below 10 msec.|Least Squares Mean Difference|-2.02|||||TWO_SIDED|90.0|-2.88|-1.16||No adjustment on CI for the primary outcome measure.|Mixed Models Analysis||The MMRM includes Treatment (Exenatide versus Placebo), Day, Time, Period, Sequence, and Day-Time-Treatment interaction as fixed effects, subject random intercept.|60 evaluable subjects gives more than 90% power to show non-inferiority of exenatide versus placebo, using t-test in 2-way crossover, alpha=0.05, true difference of 5 msec, and standard deviation of the within-subject difference of 10.04 msec.||-1.16|-2.88|
72587716|NCT03307252|144706093|OTHER||Adjusted gMean ratio|100.78|STANDARD_ERROR_OF_MEAN|10.0|||TWO_SIDED|90.0|93.59|108.51|||ANOVA||Standard Error of the mean is actually intra individual geometric coefficient of variation (gCV). Adjusted gMean ratio is given for T3 vs. R1.||Furosemide, ANOVA model on the logarithmic scale includes effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|108.51|93.59|
72587717|NCT03307252|144706093|OTHER||Adjusted gMean Ratio|131.37|STANDARD_ERROR_OF_MEAN|13.4|||TWO_SIDED|90.0|120.37|143.37|||ANOVA||Standard Error of the mean is actually intra individual geometric coefficient of variation (gCV). Adjusted gMean ratio is given for T4 vs. R1.||Furosemide, ANOVA model on the logarithmic scale includes effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|143.37|120.37|
72587718|NCT03307252|144706093|OTHER||Adjusted gMean Ratio|106.55|STANDARD_ERROR_OF_MEAN|12.8|||TWO_SIDED|90.0|96.87|117.19|||ANOVA||Standard Error of the mean is actually intra individual geometric coefficient of variation (gCV). Adjusted gMean ratio is given for T3 vs. R1.||Rosuvastatin, ANOVA model on the logarithmic scale includes effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|117.19|96.87|
72587719|NCT03307252|144706094|OTHER||Adjusted gMean ratio|260.11|STANDARD_ERROR_OF_MEAN|14.7|||TWO_SIDED|90.0|237.96|284.32|||ANOVA||Standard Error of the mean is actually intra individual geometric coefficient of variation (gCV). Adjusted gMean ratio is given for T4 vs. R1.||Furosemide, ANOVA model on the logarithmic scale includes effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|284.32|237.96|
72587720|NCT03307252|144706094|OTHER||Adjusted gMean Ratio|101.21|STANDARD_ERROR_OF_MEAN|9.4|||TWO_SIDED|90.0|95.15|107.66|||ANOVA||Standard Error of the mean is actually intra individual geometric coefficient of variation (gCV). Adjusted gMean ratio is given for T4 vs. R1.||Metformin, ANOVA model on the logarithmic scale includes effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|107.66|95.15|
72587721|NCT03307252|144706094|OTHER||Adjusted gMean Ratio|215.28|STANDARD_ERROR_OF_MEAN|13.1|||TWO_SIDED|90.0|197.53|234.63|||ANOVA||Standard Error of the mean is actually intra individual geometric coefficient of variation (gCV). Adjusted gMean ratio is given for T4 vs. R1.||Rosuvastatin, ANOVA model on the logarithmic scale includes effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|234.63|197.53|
72552352|NCT04239872|144635457|SUPERIORITY||Mean Difference (Net)|0.3306||||0.1515|TWO_SIDED|95.0|-0.1356|0.7969||The threshold for statistical significance was set at p=0.05.|t-test, 2 sided|Paired t-test was used; there were 16 pairs of data, DF=15|Treatment difference = Calcium mouthwash before fluoride mouthwash - Fluoride mouthwash|A paired t-test was used to compare the two groups.||0.7969|-0.1356|0.1515
72552353|NCT04239872|144635458|SUPERIORITY||Mean Difference (Net)|0.04851||||0.1712|TWO_SIDED|95.0|-0.02327|0.1203||The threshold for statistical significance was set at p=0.05.|t-test, 2 sided|Paired t-test was used; there were 17 pairs of data, DF=16|Treatment difference of transformed (log10) data = Calcium mouthwash before fluoride mouthwash - Fluoride mouthwash|A paired t-test was used to compare the two groups. To obtain normal distribution, data used in the statistical analysis were transformed to the log10.||0.1203|-0.02327|0.1712
72587722|NCT03482453|144706099|EQUIVALENCE|A linear mixed effect model on the natural log-transformed parameters was performed with regimen, sequence and period as a fixed effect and subject nested within sequence as a random effect. The least square means (LS means) for the log-transformed parameters were exponentiated to obtain the point estimates and 90 percent (%) Confidence Intervals (CIs) of the geometric LS mean ratio on the original scale.|Geometric LS Mean Ratio|0.881|||||TWO_SIDED|90.0|0.7108|1.0921||||||||1.0921|0.7108|
72587723|NCT03482453|144706099|EQUIVALENCE|A linear mixed effect model on the natural log-transformed parameters was performed with regimen, sequence and period as a fixed effect and subject nested within sequence as a random effect. The LS means for the log-transformed parameters were exponentiated to obtain the point estimates and 90% CIs of the geometric LS mean ratio on the original scale.|Geometric LS Mean Ratio|0.9637|||||TWO_SIDED|90.0|0.8361|1.1107||||||||1.1107|0.8361|
72552354|NCT04239872|144635459|SUPERIORITY||Mean Difference (Net)|0.2789||||0.1188|TWO_SIDED|95.0|-0.07934|0.6371||The threshold for statistical significance was set at p=0.05.|t-test, 2 sided|Paired t-test was used; there were 18 pairs of data, DF=17|Treatment difference = Calcium mouthwash before fluoride mouthwash - Fluoride mouthwash|A paired t-test was used to compare the two groups.||0.6371|-0.07934|0.1188
72552355|NCT04239872|144635460|SUPERIORITY||Mean Difference (Net)|0.8956|||<|0.0001|TWO_SIDED|95.0|0.7205|1.071||The threshold for statistical significance was set at p=0.05.|t-test, 2 sided|Paired t-test was used; there were 14 pairs of data, DF=13|Treatment difference of transformed (log10) data = Calcium mouthwash before fluoride mouthwash - Fluoride mouthwash|A paired t-test was used to compare the two groups. To obtain normal distribution, data used in the statistical analysis were transformed to the log10.||1.071|0.7205|<0.0001
72587724|NCT03482453|144706100|EQUIVALENCE|A linear mixed effect model on the natural log-transformed parameters was performed with regimen, sequence and period as a fixed effect and subject nested within sequence as a random effect. The LS means for the log-transformed parameters were exponentiated to obtain the point estimates and 90% CIs of the geometric LS mean ratio on the original scale.|Geometric LS Mean Ratio|0.9317|||||TWO_SIDED|90.0|0.8458|1.0263||||||||1.0263|0.8458|
72587725|NCT03482453|144706105|EQUIVALENCE|A linear mixed effect model on the natural log-transformed parameters was performed with regimen, sequence and period as a fixed effect and subject nested within sequence as a random effect. The LS means for the log-transformed parameters were exponentiated to obtain the point estimates and 90% CIs of the geometric LS mean ratio on the original scale.|Geometric LS Mean Ratio|1.0153|||||TWO_SIDED|90.0|0.8977|1.1483||||||||1.1483|0.8977|
72587726|NCT03482453|144706105|EQUIVALENCE|A linear mixed effect model on the natural log-transformed parameters was performed with regimen, sequence and period as a fixed effect and subject nested within sequence as a random effect. The LS means for the log-transformed parameters were exponentiated to obtain the point estimates and 90% CIs of the geometric LS mean ratio on the original scale.|Geometric LS Mean Ratio|0.9506|||||TWO_SIDED|90.0|0.874|1.0339||||||||1.0339|0.8740|
72587727|NCT03482453|144706106|EQUIVALENCE|A linear mixed effect model on the natural log-transformed parameters was performed with regimen, sequence and period as a fixed effect and subject nested within sequence as a random effect. The LS means for the log-transformed parameters were exponentiated to obtain the point estimates and 90% CIs of the geometric LS mean ratio on the original scale.|Geometric LS Mean Ratio|0.9603|||||TWO_SIDED|90.0|0.8861|1.0408||||||||1.0408|0.8861|
72587728|NCT02157376|144706129|NON_INFERIORITY_OR_EQUIVALENCE|If the lower bound of the two-sided 95% confidence interval for the difference is larger than -0.05, the non-inferiority claim will be met.|Risk Difference (RD)|1.9||||0.393|TWO_SIDED|95.0|-2.8|6.5|||Pearson's Chi-square||The difference in treatment group percentages is given by Cimetidine minus Esomeprazole.|Assuming a bleeding percent of 6.3% for the active comparator, a risk reduction of 3.7% for esomeprazole, and a 5% non-inferiority margin, 150 patients per treatment arm will provide 94% power to demonstrate non-inferiority. The null hypothesis is that the bleeding rate for iv esomeprazole 40 mg bid exceeds the rate for iv cimetidine by an amount at least as large as 5%.||6.5|-2.8|0.393
72587729|NCT01578239|144706148|SUPERIORITY||Hazard Ratio (HR)|0.177|||<|0.0001|TWO_SIDED|95.0|0.108|0.289||Derived from a two-sided test between the two groups|Log Rank||Hazard ratio is expressed as Lu-DOTA-Tyr-Octreotate / Octreotide LAR and estimated from the corresponding Cox model.|||0.289|0.108|<0.0001
72587730|NCT01578239|144706149|SUPERIORITY|||||||0.0141|||||||Fisher Exact|||||||0.0141
72587731|NCT01578239|144706150|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.3039|TWO_SIDED|95.0|0.6|1.17|||Log Rank|||||1.17|0.60|0.3039
72587732|NCT01578239|144706151|SUPERIORITY||Cox Proportional Hazard|0.84||||0.3039|TWO_SIDED|95.0|0.6|1.17|||Log Rank||Hazard Ratio of Lu-DOTA-Tyr-Octreotate vs. Octreotide LAR|||1.17|0.60|0.3039
72587733|NCT01578239|144706152|SUPERIORITY||Hazard Ratio (HR)|0.137|||<|0.0001|TWO_SIDED|95.0|0.077|0.242|||Log Rank|||||0.242|0.077|<0.0001
72587734|NCT02347813|144706166|OTHER||Mean Difference (Final Values)|0.5||||0.75|TWO_SIDED|95.0|||||ANOVA|||||||0.750
72587735|NCT01385137|144706168|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.17||||0.58|TWO_SIDED|95.0|-0.79|0.44|||Regression, Linear|||||0.44|-0.79|0.58
72587736|NCT01385137|144706170|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.13||||0.42|TWO_SIDED|95.0|-7.3|3.04|||Regression, Linear|||||3.04|-7.30|0.42
72587737|NCT01385137|144706171|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.72||||0.77|TWO_SIDED|95.0|-4.17|5.6|||Regression, Linear|||||5.60|-4.17|0.77
72587738|NCT01385137|144706172|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.14||||0.21|TWO_SIDED|95.0|-1.16|5.44|||Regression, Linear|||||5.44|-1.16|0.21
72587739|NCT02837731|144706173|SUPERIORITY||Mean Difference (Final Values)|-1.37||||0.021|TWO_SIDED|95.0|-2.53|0.21|||t-test, 2 sided|||||0.21|-2.53|0.021
72587740|NCT02837731|144706174|OTHER||Mean Difference (Final Values)|-0.124||||0.042|TWO_SIDED|95.0|-0.27|-0.01|||Fisher Exact||Converted Estimated Value of -12.4% to decimal value of -0.124.|||-0.01|-0.27|0.042
72587741|NCT02837731|144706175|OTHER||Mean Difference (Final Values)|-0.1642||||0.044|TWO_SIDED|95.0|-0.33|0.0|||Chi-squared||Converted Estimated Value of -16.42% to decimal value of -0.1642.|||0|-0.33|0.044
72587742|NCT02837731|144706176|OTHER||Mean Difference (Final Values)|-2.91||||0.113|TWO_SIDED|95.0|-6.67|0.85|||Fisher Exact|||||0.85|-6.67|0.113
72587743|NCT02837731|144706177|OTHER||Mean Difference (Final Values)|-72.43|||||TWO_SIDED|95.0|-154.08|9.22|||Wilcoxon (Mann-Whitney)|||||9.22|-154.08|
72587744|NCT02837731|144706178|OTHER||Mean Difference (Final Values)|-14.91||||0.426|TWO_SIDED|95.0|-52.5|22.68|||Wilcoxon (Mann-Whitney)|||||22.68|-52.50|0.426
72587745|NCT02837731|144706179|OTHER||Mean Difference (Final Values)|0.09||||0.453|TWO_SIDED|95.0|-0.34|0.52|||ANCOVA|||||0.52|-0.34|0.453
72587746|NCT02644668|144706195|SUPERIORITY||Least squares mean difference|-0.01|STANDARD_ERROR_OF_MEAN|0.06||0.9086|TWO_SIDED|95.0|-0.13|0.11|||Mixed Models Analysis|||||0.11|-0.13|0.9086
72587747|NCT02644668|144706195|SUPERIORITY||Least squares mean difference|-0.05|STANDARD_ERROR_OF_MEAN|0.065||0.4361|TWO_SIDED|95.0|-0.18|0.08|||Mixed Models Analysis|||||0.08|-0.18|0.4361
72587748|NCT02644668|144706196|SUPERIORITY||Least squares mean difference|-2.94|STANDARD_ERROR_OF_MEAN|4.749||0.5382|TWO_SIDED|95.0|-12.43|6.55|||Mixed Models Analysis|||||6.55|-12.43|0.5382
72587749|NCT02644668|144706196|SUPERIORITY||Least squares mean difference|0.99|STANDARD_ERROR_OF_MEAN|5.099||0.8464|TWO_SIDED|95.0|-9.19|11.18|||Mixed Models Analysis|||||11.18|-9.19|0.8464
72587750|NCT02644668|144706197|SUPERIORITY||Least squares mean difference|11.69|STANDARD_ERROR_OF_MEAN|5.506||0.0378|TWO_SIDED|95.0|0.68|22.7|||Mixed Models Analysis|||||22.70|0.68|0.0378
72587751|NCT02644668|144706197|SUPERIORITY||Least squares mean difference|13.15|STANDARD_ERROR_OF_MEAN|5.913||0.0298|TWO_SIDED|95.0|1.33|24.97|||Mixed Models Analysis|||||24.97|1.33|0.0298
72587752|NCT02644668|144706198|SUPERIORITY||Least squares mean difference|-4.59|STANDARD_ERROR_OF_MEAN|7.56||0.5461|TWO_SIDED|95.0|-19.69|10.52|||Mixed Models Analysis|||||10.52|-19.69|0.5461
72587753|NCT02644668|144706198|SUPERIORITY||Least squares mean difference|-15.23|STANDARD_ERROR_OF_MEAN|8.175||0.0672|TWO_SIDED|95.0|-31.56|1.11|||Mixed Models Analysis|||||1.11|-31.56|0.0672
72587754|NCT02644668|144706199|SUPERIORITY||Least squares mean difference|-0.38|STANDARD_ERROR_OF_MEAN|0.928||0.6849|TWO_SIDED|95.0|-2.23|1.48|||Mixed Models Analysis|||||1.48|-2.23|0.6849
72587755|NCT02644668|144706199|SUPERIORITY||Least squares mean difference|-1.0|STANDARD_ERROR_OF_MEAN|0.98||0.3091|TWO_SIDED|95.0|-2.96|0.95|||Mixed Models Analysis|||||0.95|-2.96|0.3091
72587756|NCT02644668|144706200|SUPERIORITY||Least squares mean difference|0.61|STANDARD_ERROR_OF_MEAN|0.571||0.2878|TWO_SIDED|95.0|-0.53|1.75|||Mixed Models Analysis|||||1.75|-0.53|0.2878
72587757|NCT02644668|144706200|SUPERIORITY||Least squares mean difference|-0.12|STANDARD_ERROR_OF_MEAN|0.616||0.8512|TWO_SIDED|95.0|-1.34|1.11|||Mixed Models Analysis|||||1.11|-1.34|0.8512
72587758|NCT02644668|144706201|SUPERIORITY||Least squares mean difference|-0.78|STANDARD_ERROR_OF_MEAN|2.528||0.7612|TWO_SIDED|95.0|-6.08|4.52|||Mixed Models Analysis|||||4.52|-6.08|0.7612
72587759|NCT02644668|144706201|SUPERIORITY||Least squares mean difference|-3.1|STANDARD_ERROR_OF_MEAN|3.231||0.3502|TWO_SIDED|95.0|-9.91|3.7|||Mixed Models Analysis|||||3.70|-9.91|0.3502
72587760|NCT02644668|144706202|SUPERIORITY||Least squares mean difference|7.72|STANDARD_ERROR_OF_MEAN|10.484||0.4684|TWO_SIDED|95.0|-13.86|29.3|||Mixed Models Analysis|||||29.30|-13.86|0.4684
72587761|NCT02644668|144706202|SUPERIORITY||Least squares mean difference|24.89|STANDARD_ERROR_OF_MEAN|12.55||0.0584|TWO_SIDED|95.0|-0.95|50.74|||Mixed Models Analysis|||||50.74|-0.95|0.0584
72587762|NCT02644668|144706203|SUPERIORITY||Odds Ratio (OR)|0.43||||0.1686|TWO_SIDED|95.0|0.13|1.43|||Regression, Logistic|||Odds ratio of active vs placebo comparison of the patients' global assessment of better than pre-dose vs same or worse than pre-dose||1.43|0.13|0.1686
72587763|NCT02644668|144706203|SUPERIORITY||Odds Ratio (OR)|0.67||||0.5259|TWO_SIDED|95.0|0.2|2.3|||Regression, Logistic|||Odds ratio of active vs placebo comparison of the patients' global assessment of better than pre-dose vs same or worse than pre-dose||2.30|0.20|0.5259
72587764|NCT02644668|144706204|SUPERIORITY||Odds Ratio (OR)|1.22||||0.7655|TWO_SIDED|95.0|0.34|4.4|||Regression, Logistic|||Odds ratio of active vs placebo comparison of the patients' global assessment of better than pre-dose vs same or worse than pre-dose||4.40|0.34|0.7655
72587765|NCT02644668|144706204|SUPERIORITY||Odds Ratio (OR)|1.61||||0.492|TWO_SIDED|95.0|0.41|6.25|||Regression, Logistic|||Odds ratio of active vs placebo comparison of the patients' global assessment of better than pre-dose vs same or worse than pre-dose||6.25|0.41|0.4920
72587766|NCT02547220|144706242|SUPERIORITY||Difference in percentage|2.6||||0.6857|TWO_SIDED|95.0|-29.4|34.5|||Fisher Exact||Difference in percentage was calculated by the difference in percentage of new or worsening TG at 6 months between CINRYZE and placebo|||34.5|-29.4|0.6857
72587767|NCT03771560|144706280|OTHER||Mean Difference (Final Values)|-2.4||||0.56|TWO_SIDED|95.0|-11.3|6.4|||Paired Sample t-test|||The parent-reported change in mean ABC total score from baseline to week 12.||6.4|-11.3|0.56
72587768|NCT03771560|144706281|OTHER||Mean Difference (Final Values)|1.2||||0.68|TWO_SIDED|95.0|-5.2|7.6|||Paired Sample t-test|||The teacher-reported change in mean ABC total score from baseline to week 12.||7.6|-5.2|0.68
72587769|NCT03771560|144706282|OTHER||Mean Difference (Final Values)|-7.8||||0.095|TWO_SIDED|95.0|-17.3|1.6|||Paired Sample t-test|||The parent-reported change in mean SRS total score from baseline to week 12.||1.6|-17.3|0.095
72587770|NCT03771560|144706283|OTHER||Median Difference (Final Values)|-0.5||||0.95|TWO_SIDED|95.0|-7.0|13.5|||Wilcoxon (Mann-Whitney)|||The teacher-reported change in mean SRS total score from baseline to week 12.||13.5|-7.0|0.95
72587771|NCT03771560|144706284|OTHER||Mean Difference (Final Values)|-0.8||||0.69|TWO_SIDED|95.0|-5.2|3.5|||Paired Sample t-test|||The parent-reported change in mean PedsQL total score from baseline to week 12.||3.5|-5.2|0.69
72587772|NCT02887183|144706285|OTHER||Least Squared Geometric Mean Ratio|0.632|||<|0.0001|TWO_SIDED|95.0|0.5865|0.681|||ANCOVA|||||0.6810|0.5865|<.0001
72587773|NCT02887183|144706286|OTHER||Least Squared Mean|-7.57|||<|0.0001|TWO_SIDED|95.0|-7.98|-7.15|||ANCOVA|||LAVi||-7.15|-7.98|<.0001
72587774|NCT02887183|144706286|OTHER||Least Squared Mean|-12.25|||<|0.0001|TWO_SIDED|95.0|-12.92|-11.58|||ANCOVA|||LVEDVi||-11.58|-12.92|<.0001
72587775|NCT02887183|144706286|OTHER||Least Squared Mean|-15.29|||<|0.0001|TWO_SIDED|95.0|-16.03|-14.55|||ANCOVA|||LVESVi||-14.55|-16.03|<.0001
72587776|NCT02887183|144706287|OTHER||Least Squared Mean|9.37|||<|0.001|TWO_SIDED|95.0|8.84|9.9|||ANCOVA|||||9.90|8.84|<.001
72587777|NCT02887183|144706288|OTHER|Pearson's Correlation|||||<|0.0001|TWO_SIDED|95.0|||||t-test, 2 sided|||LVESVi, LVEDVi, LAVi. LVEF||||<.0001
72587778|NCT02887183|144706289|OTHER|Pearson's Correlation|||||<|0.0001|TWO_SIDED|95.0|||||t-test, 2 sided|||LVESVi, LVEDVi, LAVi. LVEF||||<.0001
72414028|NCT01297062|144337100|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is established if the upper limit of 2-sided 90% CI, equivalent to the upper limit of 1-sided 95% CI, for change from baseline in QTcP (exenatide - placebo) is below 10 msec.|Least Squares Mean Difference|-1.13|||||TWO_SIDED|90.0|-2.11|-0.15||No adjustment on CI for the primary outcome measure.|Mixed Models Analysis||The MMRM includes Treatment (Exenatide versus Placebo), Day, Time, Period, Sequence, and Day-Time-Treatment interaction as fixed effects, subject random intercept.|60 evaluable subjects gives more than 90% power to show non-inferiority of exenatide versus placebo, using t-test in 2-way crossover, alpha=0.05, true difference of 5 msec, and standard deviation of the within-subject difference of 10.04 msec.||-0.15|-2.11|
72414029|NCT01297062|144337101|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|5.47|||||TWO_SIDED|90.0|2.82|8.12|||Mixed Models Analysis||The MMRM includes Treatment (Moxifloxacin versus Placebo), Time, Period, Sequence, and Time-Treatment interaction as fixed effects, subject random intercept. Multiplicity adjusted CI for the mean difference is shown.|Assay sensitivity of moxifloxacin is established if the lower limit of the 2-sided 90% CI for difference in change from baseline in QTcP (moxifloxacin - placebo) is greater than 5 msec.||8.12|2.82|
72414030|NCT01297062|144337102|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|10.56|||||TWO_SIDED|90.0|8.46|12.67|||Mixed Models Analysis||The MMRM includes Treatment (Moxifloxacin versus Placebo), Time, Period, Sequence, and Time-Treatment interaction as fixed effects, subject random intercept. Multiplicity adjusted CI for the mean difference is shown.|Assay sensitivity of moxifloxacin is established if the lower limit of the 2-sided 90% CI for difference in change from baseline in QTcP (moxifloxacin - placebo) is greater than 5 msec.||12.67|8.46|
72587779|NCT02887183|144706290|OTHER|Pearson's Correlation|||||<|0.0001|TWO_SIDED|95.0|||||t-test, 2 sided|||Subjects with new onset HF and/or RAAS naïve||||<.0001
72587780|NCT02887183|144706290|OTHER|Pearson's Correlation||||||0.0003|TWO_SIDED|95.0|||||t-test, 2 sided|||"Subjects with HFrEF and low NT-proBNP"||||0.0003
72587781|NCT02887183|144706290|OTHER|Pearson's Correlation||||||0.0956|TWO_SIDED|95.0|||||t-test, 2 sided|||Subjects not receiving target dose||||0.0956
72587782|NCT02887183|144706291|OTHER|Pearson's Correlation||||||0.006|TWO_SIDED|95.0|||||t-test, 2 sided|||Subjects with new onset HF and/or RAAS naïve||||0.0060
72587783|NCT02887183|144706291|OTHER|Pearson's Correlation||||||0.0012|TWO_SIDED|95.0|||||t-test, 2 sided|||"Subjects with HFrEF and low NT-proBNP"||||0.0012
72587784|NCT02887183|144706291|OTHER|Pearson's Correlation||||||0.0181|TWO_SIDED|95.0|||||t-test, 2 sided|||Subjects not receiving target dose||||0.0181
72587785|NCT02887183|144706292|OTHER|Pearson's Correlation||||||0.2498|TWO_SIDED|95.0|||||t-test, 2 sided|||Subjects with new onset HF and/or RAAS naïve||||0.2498
72587786|NCT02887183|144706292|OTHER|Pearson's Correlation||||||0.0495|TWO_SIDED|95.0|||||t-test, 2 sided|||"Subjects with HFrEF and low NT-proBNP"||||0.0495
72587787|NCT02887183|144706292|OTHER|Pearson's Correlation||||||0.2685|TWO_SIDED|95.0|||||t-test, 2 sided|||Subjects not receiving target dose||||0.2685
72587788|NCT02887183|144706293|OTHER|Pearson's Correlation||||||0.0029|TWO_SIDED|95.0|||||t-test, 2 sided|||Subjects with new onset HF and/or RAAS naïve||||0.0029
72587789|NCT02887183|144706293|OTHER|Pearson's Correlation||||||0.0011|TWO_SIDED|95.0|||||t-test, 2 sided|||"Subjects with HFrEF and low NT-proBNP"||||0.0011
72587790|NCT02887183|144706293|OTHER|Pearson's Correlation||||||0.0012|TWO_SIDED|95.0|||||t-test, 2 sided|||Subjects not receiving target dose||||0.0012
72587791|NCT02887183|144706294|OTHER||Least Squared Mean|9.32|||<|0.0001|TWO_SIDED|95.0|7.94|10.69|||ANCOVA|||||10.69|7.94|<.0001
72587792|NCT01031680|144706295|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.46|STANDARD_ERROR_OF_MEAN|0.0473|<|0.0001|TWO_SIDED|95.0|-0.56|-0.37||Significant at alpha=0.025 (2-sided). A hierarchical closed testing procedure was used to control Type I error across the primary \& key secondary objectives|ANCOVA|with treatment group and stratum as effects and baseline value as covariate for each endpoint|with stratum = age-by-insulin use-by-time from most recent qualifying CV event|H0: mean(treat) minus mean(placebo) = 0 versus the alternative HA: mean(treat) minus mean(placebo) =/= 0||-0.37|-0.56|<0.0001
72587793|NCT01031680|144706296|SUPERIORITY_OR_OTHER||Risk Difference (RD)|9.9|||<|0.0001|TWO_SIDED|95.0|7.0|12.9||Significant at alpha=0.025 (2-sided). A hierarchical closed testing procedure was used to control Type I error across the primary \& key secondary objectives|Cochran-Mantel-Haenszel|with age-by-insulin use-by-time from most recent qualifying CV event as stratum||H0: proportion(treat) minus proportion(placebo) = 0 versus the alternative HA: proportion(treat) minus proportion(placebo) =/= 0||12.9|7.0|<0.0001
72587794|NCT01031680|144706297|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.97|STANDARD_ERROR_OF_MEAN|0.7898||0.0126|TWO_SIDED|95.0|-3.52|-0.42||Significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure|ANCOVA|with treatment group and stratum as effects and baseline value as covariate|with stratum = age-by-insulin use-by-time from most recent qualifying CV event|H0: mean(treat) minus mean(placebo) = 0 versus the alternative HA: mean(treat) minus mean(placebo) =/= 0||-0.42|-3.52|0.0126
72587795|NCT01031680|144706298|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.27|STANDARD_ERROR_OF_MEAN|0.191|<|0.0001||95.0|-2.64|-1.89||Significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure|ANCOVA|with treatment group and stratum as effects and baseline value as covariate|with stratum = age-by-insulin use-by-time from most recent qualifying CV event|H0: mean(treat) minus mean(placebo) = 0 versus the alternative HA: mean(treat) minus mean(placebo) =/= 0||-1.89|-2.64|<0.0001
72587796|NCT01031680|144706299|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.95|STANDARD_ERROR_OF_MEAN|0.8203||0.0174|TWO_SIDED|95.0|-3.56|-0.34||Significant at alpha=0.05 (2-sided). Key secondary endpoints are tested following a hierarchical closed testing procedure|ANCOVA|with treatment group and stratum as effects and baseline value as covariate|with stratum = age-by-insulin use-by-time from most recent qualifying CV event|H0: mean(treat) minus mean(placebo) = 0 versus the alternative HA: mean(treat) minus mean(placebo) =/= 0||-0.34|-3.56|0.0174
72587797|NCT01031680|144706300|SUPERIORITY_OR_OTHER||Risk Difference (RD)|12.5|STANDARD_ERROR_OF_MEAN|2.126|<|0.0001|TWO_SIDED|95.0|8.3|16.6||Significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure|Regression, Logistic|Based on methodology of Zhang, Tsiatis \& Davidian and Davidian, Tsiatis, Zhang \& Lu, with adjustment for baseline value and stratum (gender)||H0: proportion(treat) minus proportion(placebo) = 0 versus the alternative HA: proportion(treat) minus proportion(placebo) =/= 0||16.6|8.3|<0.0001
72587798|NCT01921101|144706309|SUPERIORITY_OR_OTHER|||||||0.29|||||||Chi-squared|||||||0.29
72587799|NCT01483027|144706314|SUPERIORITY||Hazard Ratio (HR)|0.69||||0.0013|TWO_SIDED|95.0|0.54|0.88|||Log Rank|||Analysis performed using a log-rank test||0.88|0.54|0.0013
72587800|NCT01483027|144706315|SUPERIORITY||Hazard Ratio (HR)|0.59|||<|0.0001|TWO_SIDED|95.0|0.46|0.77|||Log Rank|||Analysis performed using a log-rank test.||0.77|0.46|<0.0001
72587801|NCT00648115|144706356|SUPERIORITY_OR_OTHER||Pearson chi square|7.3|||<|0.05|TWO_SIDED|95.0|||||Chi-squared|||||||<0.05
72587802|NCT01073605|144706358|SUPERIORITY_OR_OTHER|||||||0.02922|TWO_SIDED|||||P-values for the 3 treatment comparisons should be interpreted in line with the Bonferroni stepwise (Holm) testing procedure, to maintain the Type 1 error at p=0.05.|Wilcoxon (Mann-Whitney)|||||||0.02922
72587803|NCT01073605|144706358|SUPERIORITY_OR_OTHER|||||||0.74299|TWO_SIDED|||||P-values for the 3 treatment comparisons should be interpreted in line with the Bonferroni stepwise (Holm) testing procedure, to maintain the Type 1 error at p=0.05.|Wilcoxon (Mann-Whitney)|||||||0.74299
72587804|NCT01073605|144706358|SUPERIORITY_OR_OTHER|||||||0.00467|TWO_SIDED|||||P-values for the 3 treatment comparisons should be interpreted in line with the Bonferroni stepwise (Holm) testing procedure, to maintain the Type 1 error at p=0.05.|Wilcoxon (Mann-Whitney)|||||||0.00467
72587805|NCT01073605|144706360|SUPERIORITY_OR_OTHER|||||||0.00125|TWO_SIDED|||||P-values for the 3 treatment comparisons should be interpreted in line with the Bonferroni stepwise (Holm) testing procedure, to maintain the Type 1 error at p=0.05.|Wilcoxon (Mann-Whitney)|||1 year||||0.00125
72587806|NCT01073605|144706360|SUPERIORITY_OR_OTHER|||||||0.25995|TWO_SIDED|||||P-values for the 3 treatment comparisons should be interpreted in line with the Bonferroni stepwise (Holm) testing procedure, to maintain the Type 1 error at p=0.05.|Wilcoxon (Mann-Whitney)|||1 year||||0.25995
72587807|NCT01073605|144706360|SUPERIORITY_OR_OTHER|||||||8e-05|TWO_SIDED|||||P-values for the 3 treatment comparisons should be interpreted in line with the Bonferroni stepwise (Holm) testing procedure, to maintain the Type 1 error at p=0.05.|Wilcoxon (Mann-Whitney)|||1 year||||0.00008
72587808|NCT01073605|144706360|SUPERIORITY_OR_OTHER|||||||0.03273|TWO_SIDED|||||P-values for the 3 treatment comparisons should be interpreted in line with the Bonferroni stepwise (Holm) testing procedure, to maintain the Type 1 error at p=0.05.|Wilcoxon (Mann-Whitney)|||2 years||||0.03273
72587809|NCT01073605|144706360|SUPERIORITY_OR_OTHER|||||||0.68581|TWO_SIDED|||||P-values for the 3 treatment comparisons should be interpreted in line with the Bonferroni stepwise (Holm) testing procedure, to maintain the Type 1 error at p=0.05.|Wilcoxon (Mann-Whitney)|||2 years||||0.68581
72587810|NCT01073605|144706360|SUPERIORITY_OR_OTHER|||||||0.0053|TWO_SIDED|||||P-values for the 3 treatment comparisons should be interpreted in line with the Bonferroni stepwise (Holm) testing procedure, to maintain the Type 1 error at p=0.05.|Wilcoxon (Mann-Whitney)|||2 years||||0.00530
72587811|NCT01073605|144706360|SUPERIORITY_OR_OTHER|||||||0.57556|TWO_SIDED|||||P-values for the 3 treatment comparisons should be interpreted in line with the Bonferroni stepwise (Holm) testing procedure, to maintain the Type 1 error at p=0.05.|Wilcoxon (Mann-Whitney)|||3 years||||0.57556
72587812|NCT01073605|144706360|SUPERIORITY_OR_OTHER|||||||0.63956|TWO_SIDED|||||P-values for the 3 treatment comparisons should be interpreted in line with the Bonferroni stepwise (Holm) testing procedure, to maintain the Type 1 error at p=0.05.|Wilcoxon (Mann-Whitney)|||3 years||||0.63956
72587813|NCT01073605|144706360|SUPERIORITY_OR_OTHER|||||||0.16421|TWO_SIDED|||||P-values for the 3 treatment comparisons should be interpreted in line with the Bonferroni stepwise (Holm) testing procedure, to maintain the Type 1 error at p=0.05.|Wilcoxon (Mann-Whitney)|||3 years||||0.16421
72587814|NCT01073605|144706364|SUPERIORITY_OR_OTHER|||||||0.0001|TWO_SIDED|||||P-values for the 3 treatment comparisons should be interpreted in line with the Bonferroni stepwise (Holm) testing procedure, to maintain the Type 1 error at p=0.05.|Wilcoxon (Mann-Whitney)|||3 years||||0.0001
72587815|NCT01073605|144706364|SUPERIORITY_OR_OTHER|||||||0.58324|TWO_SIDED|||||P-values for the 3 treatment comparisons should be interpreted in line with the Bonferroni stepwise (Holm) testing procedure, to maintain the Type 1 error at p=0.05.|Wilcoxon (Mann-Whitney)|||3 years||||0.58324
72587816|NCT01073605|144706364|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values for the 3 treatment comparisons should be interpreted in line with the Bonferroni stepwise (Holm) testing procedure, to maintain the Type 1 error at p=0.05.|Wilcoxon (Mann-Whitney)|||3 years||||<0.0001
72587817|NCT01073605|144706369|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.67||||0.0681|TWO_SIDED|95.0|-0.05|1.39||There is no adjustment for multiplicity of treatment comparisons.|ANCOVA|The Analysis of Covariance took into account the patient covariates age and gender.||||1.39|-0.05|0.0681
72587818|NCT01073605|144706369|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.05||||0.8971|TWO_SIDED|95.0|-0.65|0.74||There is no adjustment for multiplicity of treatment comparisons.|ANCOVA|The Analysis of Covariance took into account the patient covariates age and gender.||||0.74|-0.65|0.8971
72587819|NCT01073605|144706369|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.63||||0.0583|TWO_SIDED|95.0|-1.27|0.02||There is no adjustment for multiplicity of treatment comparisons.|ANCOVA|The Analysis of Covariance took into account the patient covariates age and gender.||||0.02|-1.27|0.0583
72587820|NCT00267969|144706395|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel (CMH) chi square|Stratified by baseline weight \[≤ 90kg vs \> 90 kg)\].||||||<0.001
72587821|NCT00267969|144706395|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||To control for the multiplicity for the primary endpoint analysis, the Holm's procedure was used at an overall significance level of 0.05|Cochran-Mantel-Haenszel (CMH) chi square|Stratified by baseline weight \[≤ 90kg vs \> 90 kg)\].||Null Hypothesis: No difference between ustekinumab 90 mg or 45 mg and placebo at an overall significance level of 0.05. Sample Size: With 750 patients (250 in each treatment group), simulation studies were conducted to calculate the power to detect a treatment difference in the primary endpoint between ustekinumab groups and placebo using a CMH test stratified by baseline weight \[\<=90kg vs \> 90 kg). For all the scenarios evaluated, the power is \>99% at an overall significance level of 0.05.||||<0.001
72587822|NCT00267969|144706396|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel(CMH) chi square|Stratified by baseline weight \[≤ 90kg vs \> 90 kg)\].||||||<0.001
72587823|NCT00267969|144706396|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||To control the multiplicity for the primary and the secondary endpoint analyses, Holm's procedure was used but the two comparisons for the primary endpoint and the two comparisons for the 1st second endpoint analyses need to be significant first|Cochran-Mantel-Haenszel (CMH) chi square|Stratified by baseline weight \[≤ 90kg vs \> 90 kg)\].||Null Hypothesis: No difference between ustekinumab 90 mg or 45 mg and placebo at an overall significance level of 0.05.||||<0.001
72587824|NCT00267969|144706397|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA on van der Waerden normal scores|Treatment and patient's baseline weight (≤ 90kg vs \> 90 kg) as factors in the model||||||<0.001
72587825|NCT00267969|144706397|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||To control the multiplicity for the primary and the secondary endpoint analyses, Holm's procedure was used but the two comparisons for the primary endpoint and the two comparisons for the 1st second endpoint analyses need to be significant first|ANOVA on van der Waerden normal scores|Treatment and patient's baseline weight (≤ 90kg vs \> 90 kg) as factors in the model||Null Hypothesis: No difference between ustekinumab 90 mg or 45 mg and placebo at an overall significance level of 0.05.||||<0.001
72587826|NCT00267969|144706398|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel (CMH) chi square|Stratified by baseline weight \[≤ 90kg vs \> 90 kg)\].||||||<0.001
72587827|NCT00267969|144706398|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel (CMH) chi square|Stratified by baseline weight \[≤ 90kg vs \> 90 kg)\].||||||<0.001
72587828|NCT00267969|144706398|SUPERIORITY_OR_OTHER|||||||0.001||95.0||||To control the overall multiplicity, the combined groups was tested first and each dose will then be tested; but the primary and the 1st 2 secondary endpoint analyses need to be significant before this endpoint can be tested|Cochran-Mantel-Haenszel (CMH) chi square|Stratified by baseline weight \[≤ 90kg vs \> 90 kg)\].||Null Hypothesis: No difference between combined maintenance group and the combined withdrawal group, ustekinumab 90 mg maintenance group and the withdrawal group, ustekinumab 45 mg maintenance group and the withdrawal group at an overall significance level of 0.05.||||0.001
72587829|NCT01309360|144706399|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|||||||1
72587830|NCT01309360|144706399|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|||||||1
72587831|NCT01309360|144706399|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|||||||1
72587832|NCT01309360|144706400|SUPERIORITY_OR_OTHER|||||||0||95.0|||||Kruskal-Wallis|||||||0
72587833|NCT01309360|144706401|SUPERIORITY_OR_OTHER|||||||0.059||95.0|||||Fisher Exact|||||||0.059
72587834|NCT01309360|144706401|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Fisher Exact|||||||<0.001
72587835|NCT01309360|144706401|SUPERIORITY_OR_OTHER|||||||0.2||95.0|||||Fisher Exact|||||||0.2
72587836|NCT01309360|144706402|SUPERIORITY_OR_OTHER|||||||0.675||95.0|||||Fisher Exact|||||||0.675
72587837|NCT01309360|144706402|SUPERIORITY_OR_OTHER|||||||0.087||95.0|||||Fisher Exact|||||||0.087
72587838|NCT01309360|144706402|SUPERIORITY_OR_OTHER|||||||0.348||95.0|||||Fisher Exact|||||||0.348
72587839|NCT01309360|144706403|SUPERIORITY_OR_OTHER|||||||0.247||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.247
72587840|NCT01309360|144706403|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.001
72587841|NCT01309360|144706403|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.001
72587842|NCT01309360|144706404|SUPERIORITY_OR_OTHER|||||||0.116||95.0|||||Fisher Exact|||||||0.116
72587843|NCT01309360|144706404|SUPERIORITY_OR_OTHER|||||||0.116||95.0|||||Fisher Exact|||||||0.116
72587844|NCT01309360|144706404|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|||||||1
72587845|NCT02308540|144706421|OTHER|GMC will be summarized by treatment group with corresponding two-sided 90% CIs based on the t-distribution to provide population estimates.|Pn IgG type 1 GMC Ratio|0.31||||0.0025|TWO_SIDED|90.0|0.17|0.57|||t-test, 2 sided|||||0.57|0.17|0.0025
72587846|NCT02308540|144706421|OTHER|GMC will be summarized by treatment group with corresponding two-sided 90% CIs based on the t-distribution to provide population estimates.|Pn IgG type 5 GMC Ratio|0.74||||0.454|TWO_SIDED|90.0|0.38|1.45|||t-test, 2 sided|||||1.45|0.38|0.4540
72587847|NCT02308540|144706421|OTHER|GMC will be summarized by treatment group with corresponding two-sided 90% CIs based on the t-distribution to provide population estimates.|Pn IgG type 6A GMC Ratio|4.69||||0.0003|TWO_SIDED|90.0|2.46|8.94|||t-test, 2 sided|||||8.94|2.46|0.0003
72587848|NCT02308540|144706421|OTHER|GMC will be summarized by treatment group with corresponding two-sided 90% CIs based on the t-distribution to provide population estimates.|Pn IgG type 6B GMC Ratio|2.22||||0.046|TWO_SIDED|90.0|1.16|4.24|||t-test, 2 sided|||||4.24|1.16|0.0460
72587849|NCT02308540|144706421|OTHER|GMC will be summarized by treatment group with corresponding two-sided 90% CIs based on the t-distribution to provide population estimates.|Pn IgG type 7F GMC Ratio|0.76||||0.3365|TWO_SIDED|90.0|0.47|1.22|||t-test, 2 sided|||||1.22|0.47|0.3365
72587850|NCT02308540|144706421|OTHER|GMC will be summarized by treatment group with corresponding two-sided 90% CIs based on the t-distribution to provide population estimates.|Pn IgG type 9V GMC Ratio|0.56||||0.0313|TWO_SIDED|90.0|0.37|0.87|||t-test, 2 sided|||||0.87|0.37|0.0313
72587851|NCT02308540|144706421|OTHER|GMC will be summarized by treatment group with corresponding two-sided 90% CIs based on the t-distribution to provide population estimates.|Pn IgG type 14 GMC Ratio|1.08||||0.806|TWO_SIDED|90.0|0.65|1.79|||t-test, 2 sided|||||1.79|0.65|0.8060
72587852|NCT02308540|144706421|OTHER|GMC will be summarized by treatment group with corresponding two-sided 90% CIs based on the t-distribution to provide population estimates.|Pn IgG type 19A GMC Ratio|1.74||||0.2044|TWO_SIDED|90.0|0.84|3.58|||t-test, 2 sided|||||3.58|0.84|0.2044
72587853|NCT02308540|144706421|OTHER|GMC will be summarized by treatment group with corresponding two-sided 90% CIs based on the t-distribution to provide population estimates.|Pn IgG type 19F GMC Ratio|1.67||||0.149|TWO_SIDED|90.0|0.93|3.02|||t-test, 2 sided|||||3.02|0.93|0.1490
72587854|NCT02308540|144706421|OTHER|GMC will be summarized by treatment group with corresponding two-sided 90% CIs based on the t-distribution to provide population estimates.|Pn IgG type 23F GMC Ratio|1.13||||0.7565|TWO_SIDED|90.0|0.59|2.15|||t-test, 2 sided|||||2.15|0.59|0.7565
72587855|NCT02308540|144706422|OTHER|GMC will be summarized by treatment group with corresponding two-sided 90% CIs based on the t-distribution to provide population estimates. Due to distributional characteristics, confidence intervals around GMCs and treatment-group ratio are estimated using bootstrap resampling (10,000 bootstrap samples).|Pn IgG type 1 GMC Ratio|0.75||||0.2653|TWO_SIDED|90.0|0.54|1.31|||Two-tailed from z-test|||||1.31|0.54|0.2653
72587856|NCT02308540|144706422|OTHER|GMC will be summarized by treatment group with corresponding two-sided 90% CIs based on the t-distribution to provide population estimates. Due to distributional characteristics, confidence intervals around GMCs and treatment-group ratio are estimated using bootstrap resampling (10,000 bootstrap samples).|Pn IgG type 5 GMC Ratio|0.69||||0.2059|TWO_SIDED|90.0|0.45|1.2|||Two-tailed from z-test|||||1.20|0.45|0.2059
72587857|NCT02308540|144706422|OTHER|GMC will be summarized by treatment group with corresponding two-sided 90% CIs based on the t-distribution to provide population estimates. Due to distributional characteristics, confidence intervals around GMCs and treatment-group ratio are estimated using bootstrap resampling (10,000 bootstrap samples).|Pn IgG type 6A GMC Ratio|0.84||||0.5664|TWO_SIDED|90.0|0.55|1.54|||Two-tailed from z-test|||||1.54|0.55|0.5664
72587858|NCT02308540|144706422|OTHER|GMC will be summarized by treatment group with corresponding two-sided 90% CIs based on the t-distribution to provide population estimates. Due to distributional characteristics, confidence intervals around GMCs and treatment-group ratio are estimated using bootstrap resampling (10,000 bootstrap samples).|Pn IgG type 6B GMC Ratio|0.82||||0.4456|TWO_SIDED|90.0|0.57|1.31|||Two-tailed from z-test|||||1.31|0.57|0.4456
72587859|NCT02308540|144706422|OTHER|GMC will be summarized by treatment group with corresponding two-sided 90% CIs based on the t-distribution to provide population estimates. Due to distributional characteristics, confidence intervals around GMCs and treatment-group ratio are estimated using bootstrap resampling (10,000 bootstrap samples).|Pn IgG type 7F GMC Ratio|0.74||||0.2189|TWO_SIDED|90.0|0.52|1.14|||Two-tailed from z-test|||||1.14|0.52|0.2189
72587860|NCT02308540|144706422|OTHER|GMC will be summarized by treatment group with corresponding two-sided 90% CIs based on the t-distribution to provide population estimates. Due to distributional characteristics, confidence intervals around GMCs and treatment-group ratio are estimated using bootstrap resampling (10,000 bootstrap samples).|Pn IgG type 9V GMC Ratio|0.6||||0.097|TWO_SIDED|90.0|0.38|1.03|||Two-tailed from z-test|||||1.03|0.38|0.0970
72587861|NCT02308540|144706422|OTHER|GMC will be summarized by treatment group with corresponding two-sided 90% CIs based on the t-distribution to provide population estimates. Due to distributional characteristics, confidence intervals around GMCs and treatment-group ratio are estimated using bootstrap resampling (10,000 bootstrap samples).|Pn IgG type 14 GMC Ratio|1.76||||0.0713|TWO_SIDED|90.0|1.02|2.79|||Two-tailed from z-test|||||2.79|1.02|0.0713
72587862|NCT02308540|144706422|OTHER|GMC will be summarized by treatment group with corresponding two-sided 90% CIs based on the t-distribution to provide population estimates. Due to distributional characteristics, confidence intervals around GMCs and treatment-group ratio are estimated using bootstrap resampling (10,000 bootstrap samples).|Pn IgG type 19A GMC Ratio|0.71||||0.3443|TWO_SIDED|90.0|0.42|1.35|||Two-tailed from z-test|||||1.35|0.42|0.3443
72587863|NCT02308540|144706422|OTHER|GMC will be summarized by treatment group with corresponding two-sided 90% CIs based on the t-distribution to provide population estimates. Due to distributional characteristics, confidence intervals around GMCs and treatment-group ratio are estimated using bootstrap resampling (10,000 bootstrap samples).|Pn IgG type 19F GMC Ratio|0.76||||0.3278|TWO_SIDED|90.0|0.48|1.23|||Two-tailed from z-test|||||1.23|0.48|0.3278
72587864|NCT02308540|144706422|OTHER|GMC will be summarized by treatment group with corresponding two-sided 90% CIs based on the t-distribution to provide population estimates. Due to distributional characteristics, confidence intervals around GMCs and treatment-group ratio are estimated using bootstrap resampling (10,000 bootstrap samples).|Pn IgG type 23F GMC Ratio|0.65||||0.2039|TWO_SIDED|90.0|0.4|1.16|||Two-tailed from z-test|||||1.16|0.40|0.2039
72587865|NCT02308540|144706423|OTHER|GMC will be summarized by treatment group with corresponding two-sided 90% CIs based on the t-distribution to provide population estimates.|Pn IgG type 1 GMC Ratio|0.89||||0.255|TWO_SIDED|90.0|0.74|1.06|||t-test, 2 sided|||||1.06|0.74|0.2550
72587866|NCT02308540|144706423|OTHER|GMC will be summarized by treatment group with corresponding two-sided 90% CIs based on the t-distribution to provide population estimates.|Pn IgG type 5 GMC Ratio|1.2||||0.0865|TWO_SIDED|90.0|1.01|1.43|||t-test, 2 sided|||||1.43|1.01|0.0865
72587867|NCT02308540|144706423|OTHER|GMC will be summarized by treatment group with corresponding two-sided 90% CIs based on the t-distribution to provide population estimates.|Pn IgG type 6A GMC Ratio|0.56||||0.0006|TWO_SIDED|90.0|0.43|0.74|||t-test, 2 sided|||||0.74|0.43|0.0006
72587868|NCT02308540|144706423|OTHER|GMC will be summarized by treatment group with corresponding two-sided 90% CIs based on the t-distribution to provide population estimates.|Pn IgG type 6B GMC Ratio|0.43|||<|0.0001|TWO_SIDED|90.0|0.33|0.57|||t-test, 2 sided|||||0.57|0.33|<0.0001
72587869|NCT02308540|144706423|OTHER|GMC will be summarized by treatment group with corresponding two-sided 90% CIs based on the t-distribution to provide population estimates.|Pn IgG type 7F GMC Ratio|0.56|||<|0.0001|TWO_SIDED|90.0|0.47|0.68|||t-test, 2 sided|||||0.68|0.47|<0.0001
72587870|NCT02308540|144706423|OTHER|GMC will be summarized by treatment group with corresponding two-sided 90% CIs based on the t-distribution to provide population estimates.|Pn IgG type 9V GMC Ratio|0.49|||<|0.0001|TWO_SIDED|90.0|0.41|0.59|||t-test, 2 sided|||||0.59|0.41|<0.0001
72587871|NCT02308540|144706423|OTHER|GMC will be summarized by treatment group with corresponding two-sided 90% CIs based on the t-distribution to provide population estimates.|Pn IgG type 14 GMC Ratio|1.11||||0.5234|TWO_SIDED|90.0|0.85|1.45|||t-test, 2 sided|||||1.45|0.85|0.5234
72587872|NCT02308540|144706423|OTHER|GMC will be summarized by treatment group with corresponding two-sided 90% CIs based on the t-distribution to provide population estimates.|Pn IgG type 19A GMC Ratio|0.29|||<|0.0001|TWO_SIDED|90.0|0.22|0.36|||t-test, 2 sided|||||0.36|0.22|<0.0001
72587873|NCT02308540|144706423|OTHER|GMC will be summarized by treatment group with corresponding two-sided 90% CIs based on the t-distribution to provide population estimates.|Pn IgG type 19F GMC Ratio|0.72||||0.004|TWO_SIDED|90.0|0.6|0.87|||t-test, 2 sided|||||0.87|0.60|0.0040
72414031|NCT01297062|144337103|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|10.92|||||TWO_SIDED|90.0|8.71|13.13|||Mixed Models Analysis||The MMRM includes Treatment (Moxifloxacin versus Placebo), Time, Period, Sequence, and Time-Treatment interaction as fixed effects, subject random intercept. Multiplicity adjusted CI for the mean difference is shown.|Assay sensitivity of moxifloxacin is established if the lower limit of the 2-sided 90% CI for difference in change from baseline in QTcP (moxifloxacin - placebo) is greater than 5 msec.||13.13|8.71|
72414032|NCT01297062|144337106|SUPERIORITY_OR_OTHER||Slope|0.0008||||0.5962|TWO_SIDED|90.0|-0.0017|0.0033|||Mixed Models Analysis||The linear mixed-effects model includes placebo-adjusted change from baseline in QTcP as response, plasma exenatide concentration as covariate, fixed intercept of zero, subject random slope.|The analysis is to test the significance of the linear regression slope (null hypothesis: slope equal to zero) between placebo-adjusted change from baseline in QTcP and exenatide concentration.||0.0033|-0.0017|0.5962
72414033|NCT01458574|144337107|SUPERIORITY_OR_OTHER||Difference in percentage|23.2|||<|0.0001|TWO_SIDED|95.0|15.3|31.2|||CMH chi-square test|||P-value based on Cochran-Mantel-Haenszel (CMH) chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95 percent (%) confidence interval (CI) based on normal approximation for the difference in binomial proportions. Missing data were imputed using Non-responder imputation (NRI).||31.2|15.3|<0.0001
72414034|NCT01458574|144337107|SUPERIORITY_OR_OTHER||Difference in percentage|29.5|||<|0.0001|TWO_SIDED|95.0|21.4|37.6|||CMH chi-square test|||P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||37.6|21.4|<0.0001
72414035|NCT01458574|144337108|SUPERIORITY_OR_OTHER||Difference in percentage|24.2|||<|0.0001|TWO_SIDED|95.0|16.0|32.5|||CMH chi-square test|||P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||32.5|16.0|<0.0001
72587874|NCT02308540|144706423|OTHER|GMC will be summarized by treatment group with corresponding two-sided 90% CIs based on the t-distribution to provide population estimates.|Pn IgG type 23F GMC Ratio|0.58||||0.0001|TWO_SIDED|90.0|0.46|0.73|||t-test, 2 sided|||||0.73|0.46|0.0001
72587875|NCT02308540|144706425|OTHER|Treatment group differences were estimated by the difference in proportion of seroresponders, with 2-sided exact 90% CIs around the difference calculated using the unconditional exact method of Newcombe. Although inference regarding seroresponse was not of primary concern in this study, a 2-sided 90% CI that excluded 0 was indicative of statistically significant difference at p ≤ 0.10 not corrected for multiplicity analysis.|Absolute Difference for Type 1|-1.0|||||TWO_SIDED|90.0|-5.13|2.66||||||||2.66|-5.13|
72414036|NCT01458574|144337108|SUPERIORITY_OR_OTHER||Difference in percentage|32.6|||<|0.0001|TWO_SIDED|95.0|24.2|41.0|||CMH chi-square test|||P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||41.0|24.2|<0.0001
72414037|NCT01458574|144337109|SUPERIORITY_OR_OTHER||Difference in percentage|30.3|||<|0.0001|TWO_SIDED|95.0|17.4|43.2|||CMH chi-square test|||P-value based on CMH chi-square test stratified by induction study treatment. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||43.2|17.4|<0.0001
72587876|NCT02308540|144706425|OTHER|Treatment group differences were estimated by the difference in proportion of seroresponders, with 2-sided exact 90% CIs around the difference calculated using the unconditional exact method of Newcombe. Although inference regarding seroresponse was not of primary concern in this study, a 2-sided 90% CI that excluded 0 was indicative of statistically significant difference at p ≤ 0.10 not corrected for multiplicity analysis.|Absolute Difference for Type 5|3.0|||||TWO_SIDED|90.0|-1.1|7.95||||||||7.95|-1.10|
72587877|NCT02308540|144706425|OTHER|Treatment group differences were estimated by the difference in proportion of seroresponders, with 2-sided exact 90% CIs around the difference calculated using the unconditional exact method of Newcombe. Although inference regarding seroresponse was not of primary concern in this study, a 2-sided 90% CI that excluded 0 was indicative of statistically significant difference at p ≤ 0.10 not corrected for multiplicity analysis.|Absolute Difference for Type 6A|-12.0|||||TWO_SIDED|90.0|-20.94|-2.97||||||||-2.97|-20.94|
72414038|NCT01458574|144337109|SUPERIORITY_OR_OTHER||Difference in percentage|42.2|||<|0.0001|TWO_SIDED|95.0|27.9|56.5|||CMH chi-square test|||P-value based on CMH chi-square test stratified by induction study treatment. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||56.5|27.9|<0.0001
72414039|NCT01458574|144337110|SUPERIORITY_OR_OTHER||Difference in percentage|22.7|||<|0.0001|TWO_SIDED|95.0|14.8|30.6|||CMH chi-square test|||P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||30.6|14.8|<0.0001
72414040|NCT01458574|144337110|SUPERIORITY_OR_OTHER||Difference in percentage|24.4|||<|0.0001|TWO_SIDED|95.0|16.4|32.4|||CMH chi-square test|||P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||32.4|16.4|<0.0001
72587878|NCT02308540|144706425|OTHER|Treatment group differences were estimated by the difference in proportion of seroresponders, with 2-sided exact 90% CIs around the difference calculated using the unconditional exact method of Newcombe. Although inference regarding seroresponse was not of primary concern in this study, a 2-sided 90% CI that excluded 0 was indicative of statistically significant difference at p ≤ 0.10 not corrected for multiplicity analysis.|Absolute Difference for Type 6B|-7.9|||||TWO_SIDED|90.0|-15.0|-1.01||||||||-1.01|-15.0|
72587879|NCT02308540|144706425|OTHER|Treatment group differences were estimated by the difference in proportion of seroresponders, with 2-sided exact 90% CIs around the difference calculated using the unconditional exact method of Newcombe. Although inference regarding seroresponse was not of primary concern in this study, a 2-sided 90% CI that excluded 0 was indicative of statistically significant difference at p ≤ 0.10 not corrected for multiplicity analysis.|Absolute Difference for Type 7F|-3.0|||||TWO_SIDED|90.0|-7.95|1.1||||||||1.10|-7.95|
72587880|NCT02308540|144706425|OTHER|Treatment group differences were estimated by the difference in proportion of seroresponders, with 2-sided exact 90% CIs around the difference calculated using the unconditional exact method of Newcombe. Although inference regarding seroresponse was not of primary concern in this study, a 2-sided 90% CI that excluded 0 was indicative of statistically significant difference at p ≤ 0.10 not corrected for multiplicity analysis.|Absolute Difference for Type 9V|-3.0|||||TWO_SIDED|90.0|-9.17|2.9||||||||2.90|-9.17|
72587881|NCT02308540|144706425|OTHER|Treatment group differences were estimated by the difference in proportion of seroresponders, with 2-sided exact 90% CIs around the difference calculated using the unconditional exact method of Newcombe. Although inference regarding seroresponse was not of primary concern in this study, a 2-sided 90% CI that excluded 0 was indicative of statistically significant difference at p ≤ 0.10 not corrected for multiplicity analysis.|Absolute Difference for Type 14|1.0|||||TWO_SIDED|90.0|-4.0|6.27||||||||6.27|-4.00|
72587882|NCT02308540|144706425|OTHER|Treatment group differences were estimated by the difference in proportion of seroresponders, with 2-sided exact 90% CIs around the difference calculated using the unconditional exact method of Newcombe. Although inference regarding seroresponse was not of primary concern in this study, a 2-sided 90% CI that excluded 0 was indicative of statistically significant difference at p ≤ 0.10 not corrected for multiplicity analysis.|Absolute Difference for Type 19A|-5.9|||||TWO_SIDED|90.0|-12.38|0.17||||||||0.17|-12.38|
72587883|NCT02308540|144706425|OTHER|Treatment group differences were estimated by the difference in proportion of seroresponders, with 2-sided exact 90% CIs around the difference calculated using the unconditional exact method of Newcombe. Although inference regarding seroresponse was not of primary concern in this study, a 2-sided 90% CI that excluded 0 was indicative of statistically significant difference at p ≤ 0.10 not corrected for multiplicity analysis.|Absolute Difference for Type 19F|0.0|||||TWO_SIDED|90.0|-4.22|4.33||||||||4.33|-4.22|
72587884|NCT02308540|144706425|OTHER|Treatment group differences were estimated by the difference in proportion of seroresponders, with 2-sided exact 90% CIs around the difference calculated using the unconditional exact method of Newcombe. Although inference regarding seroresponse was not of primary concern in this study, a 2-sided 90% CI that excluded 0 was indicative of statistically significant difference at p ≤ 0.10 not corrected for multiplicity analysis.|Absolute Difference for Type 23F|-6.0|||||TWO_SIDED|90.0|-12.77|0.4||||||||0.40|-12.77|
72414041|NCT01458574|144337111|SUPERIORITY_OR_OTHER||Difference in percentage|17.2|||<|0.0001|TWO_SIDED|95.0|10.6|23.7|||CMH chi-square test|||P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||23.7|10.6|<0.0001
72414042|NCT01458574|144337111|SUPERIORITY_OR_OTHER||Difference in percentage|20.3|||<|0.0001|TWO_SIDED|95.0|13.5|27.1|||CMH chi-square test|||P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||27.1|13.5|<0.0001
72587885|NCT02308540|144706427|OTHER|Exact confidence intervals around treatment group differences are calculated based on Newcombe score. Calculation of difference and confidence interval around the difference is not possible when all subjects in both groups are responders|Absolute difference for MOPA type 1|9.1|||||TWO_SIDED|90.0|-15.55|36.11||||||||36.11|-15.55|
72587886|NCT02308540|144706427|OTHER|Exact confidence intervals around treatment group differences are calculated based on Newcombe score. Calculation of difference and confidence interval around the difference is not possible when all subjects in both groups are responders|Absolute difference for MOPA type 5|0.0|||||TWO_SIDED|90.0|-18.56|18.56||||||||18.56|-18.56|
72587887|NCT02308540|144706427|OTHER|Exact confidence intervals around treatment group differences are calculated based on Newcombe score. Calculation of difference and confidence interval around the difference is not possible when all subjects in both groups are responders|Absolute difference for MOPA type 6B|5.0|||||TWO_SIDED|90.0|-12.35|22.97||||||||22.97|-12.35|
72587888|NCT02308540|144706427|OTHER|Exact confidence intervals around treatment group differences are calculated based on Newcombe score. Calculation of difference and confidence interval around the difference is not possible when all subjects in both groups are responders|Absolute difference for MOPA type 14|5.3|||||TWO_SIDED|90.0|-12.15|24.01||||||||24.01|-12.15|
72414043|NCT01458574|144337112|SUPERIORITY_OR_OTHER||Difference in percentage|26.8|||<|0.0001|TWO_SIDED|95.0|18.1|35.5|||CMH chi-square test|||P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||35.5|18.1|<0.0001
72587889|NCT02308540|144706427|OTHER|Exact confidence intervals around treatment group differences are calculated based on Newcombe score. Calculation of difference and confidence interval around the difference is not possible when all subjects in both groups are responders|Absolute difference for MOPA type 19A|-5.9|||||TWO_SIDED|90.0|-26.41|11.01||||||||11.01|-26.41|
72587890|NCT02308540|144706427|OTHER|Exact confidence intervals around treatment group differences are calculated based on Newcombe score. Calculation of difference and confidence interval around the difference is not possible when all subjects in both groups are responders|Absolute difference for MOPA type 19F|5.0|||||TWO_SIDED|90.0|-11.64|22.97||||||||22.97|-11.64|
72587891|NCT02649439|144706437|SUPERIORITY|||||||0.4852|||||||Wilcoxon signed rank test|||||||0.4852
72587892|NCT02649439|144706438|SUPERIORITY|||||||0.3269|||||||Wilcoxon signed rank test|||||||0.3269
72587893|NCT02649439|144706441|SUPERIORITY|||||||0.0255||||||The reported p-value is representative of the PBMCs in monocyte nonclassical between responders and non-responders.|Mann Whitney Test|||||||0.0255
72587894|NCT02649439|144706441|OTHER|||||||0.0021||||||The reported p-value is representative of the PBMCs in monocyte nonclassical PD-L1+ between responders and non-responders.|Mann Whitney Test|||||||0.0021
72587895|NCT02649439|144706441|SUPERIORITY|||||||0.0486||||||The reported p-value is representative of the PBMCs in monocyte PD-1+ between responders and non-responders.|Mann Whitney Test|||||||0.0486
72587896|NCT02649439|144706442|SUPERIORITY|||||||0.7317||||||The reported p-value is representative of the PBMCs in CD4 between responders and non-responders.|Mann Whitney Test|||||||0.7317
72587897|NCT02649439|144706442|SUPERIORITY|||||||0.7545||||||The reported p-value is representative of the PBMCs in CD8 between responders and non-responders.|Mann Whitney Test|||||||0.7545
72587898|NCT02649439|144706442|SUPERIORITY|||||||0.531||||||The reported p-value is representative of the PBMCs in Treg between responders and non-responders.|Mann Whitney Test|||||||0.5310
72587899|NCT02649439|144706442|SUPERIORITY|||||||0.8451||||||The reported p-value is representative of the PBMCs in NK between responders and non-responders.|Mann Whitney Test|||||||0.8451
72587900|NCT02649439|144706442|SUPERIORITY|||||||0.9377||||||The reported p-value is representative of the PBMCs in MDSC between responders and non-responders.|Mann Whitney Test|||||||0.9377
72587901|NCT02649439|144706443|SUPERIORITY|||||||0.2012||||||The reported p-value is representative of the % of CD4 in PBMCs at Day 1 and Day 29.|Wilcoxon signed rank test|||||||0.2012
72587902|NCT02649439|144706443|SUPERIORITY|||||||0.4891||||||The reported p-value is representative of the % of CD8 in PBMCs at Day 1 and Day 29.|Wilcoxon signed rank test|||||||0.4891
72587903|NCT02649439|144706443|SUPERIORITY|||||||0.4609||||||The reported p-value is representative of the % of Tregs in PBMCs at Day 1 and Day 29.|Wilcoxon signed rank test|||||||0.4609
72587904|NCT02649439|144706443|SUPERIORITY|||||||0.0012||||||The reported p-value is representative of the % of NK in PBMCs at Day 1 and Day 29.|Wilcoxon signed rank test|||||||0.0012
72587905|NCT02649439|144706443|SUPERIORITY|||||||0.0825||||||The reported p-value is representative of the % of MDSC in PBMCs at Day 1 and Day 29.|Wilcoxon signed rank test|||||||0.0825
72587906|NCT02649439|144706443|SUPERIORITY|||||||0.5988||||||The reported p-value is representative of the % of naïve CD4 in PBMCs at Day 1 and Day 29.|Wilcoxon signed rank test|||||||0.5988
72587907|NCT02649439|144706443|SUPERIORITY|||||||0.592|||||||Wilcoxon signed rank test|The reported p-value is representative of the % of naïve CD8 in PBMCs at Day 1 and Day 29.||||||0.5920
72587908|NCT02649439|144706443|SUPERIORITY|||||||0.6221||||||The reported p-value is representative of the % of CD4 in PBMCs at Day 1 and Day 29.|Wilcoxon signed rank test|||||||0.6221
72587909|NCT02649439|144706443|SUPERIORITY|||||||0.7334||||||The reported p-value is representative of the % of CD8 in PBMCs at Day 1 and Day 29.|Wilcoxon signed rank test|||||||0.7334
72587910|NCT02649439|144706443|OTHER|||||||0.791||||||The reported p-value is representative of the % of Tregs in PBMCs at Day 1 and Day 29.|Wilcoxon signed rank test|||||||0.7910
72587911|NCT02649439|144706443|SUPERIORITY|||||||0.5186||||||The reported p-value is representative of the % of NK in PBMCs at Day 1 and Day 29.|Wilcoxon signed rank test|||||||0.5186
72587912|NCT02649439|144706443|SUPERIORITY|The reported p-value is representative of the % of MDSC in PBMCs at Day 1 and Day 29.||||||0.5186|||||||Wilcoxon signed rank test|||||||0.5186
72587913|NCT02649439|144706443|SUPERIORITY|||||||0.9097||||||The reported p-value is representative of the % of naïve CD4 in PBMCs at Day 1 and Day 29.|Wilcoxon signed rank test|||||||0.9097
72587914|NCT02649439|144706443|SUPERIORITY|||||||0.7334||||||The reported p-value is representative of the % of naïve CD8 in PBMCs at Day 1 and Day 29.|Wilcoxon signed rank test|||||||0.7334
72587915|NCT00945035|144706444|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Study Primary Hypothesis: The plasma etoricoxib AUC(0-∞) and Cmax values following a single-dose administration of the 120 mg etoricoxib (30%) URC formulation will be bioequivalent to the plasma AUC(0-∞) and Cmax of 120 mg etoricoxib (20%) in the FMI formulation following single-dose administration (geometric mean ratio \[GMR\] no less than 0.8 and no greater than 1.25).|Least-Squares Mean Ratio|1.02||||||90.0|0.97|1.07||||||Least-Squares Mean Ratio (B/A); A=FMI Formulation (20%), Final Market Image; B=URC Formulation (30%), Unmilled Roller Compaction||1.07|0.97|
72587916|NCT00945035|144706445|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Study Primary Hypothesis: The plasma etoricoxib AUC(0-∞) and Cmax values following a single-dose administration of the 120 mg etoricoxib (30%) URC formulation will be bioequivalent to the plasma AUC(0-∞) and Cmax of 120 mg etoricoxib (20%) in the FMI formulation following single-dose administration (geometric mean ratio \[GMR\] no less than 0.8 and no greater than 1.25).|Least-Squares Mean Ratio|1.03||||||90.0|0.95|1.11||||||Least-Squares Mean Ratio (B/A); A=FMI Formulation (20%), Final Market Image; B=URC Formulation (30%), Unmilled Roller Compaction||1.11|0.95|
72587917|NCT02016105|144706475|EQUIVALENCE|Adjusted response rates were estimated using a logistic regression model including treatment, body weight strata, region and prior systemic therapy. The 95% CI for the rate difference was derived based on the normal approximation and standard error computed using the delta method.To conclude equivalent efficacy, the 95% CI had to be entirely within the interval \[-18%, 18%\].|Risk Difference (RD)|1.8|STANDARD_ERROR_OF_MEAN|4.75|||TWO_SIDED|95.0|-7.46|11.15||||||||11.15|-7.46|
72587918|NCT02016105|144706476|EQUIVALENCE|"LS means, SE and 95% CI were estimated by a Mixed Model Repeated Measures (MMRM) model with treatment, visit, treatment-by-visit interaction, body weight strata, region and prior systemic therapy, as fixed factors and baseline PASI score as covariate.~Therapeutic equivalence in terms of the % change from baseline in PASI score was to be determined if the 95% CI for the difference between GP2017 and Humira treatment was contained within the interval \[-15%; 15%\]."|LS means difference|0.8|STANDARD_ERROR_OF_MEAN|2.03|||TWO_SIDED|95.0|-3.15|4.84||||||||4.84|-3.15|
72414044|NCT01458574|144337112|SUPERIORITY_OR_OTHER||Difference in percentage|29.0|||<|0.0001|TWO_SIDED|95.0|20.3|37.7|||CMH chi-square test|||P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||37.7|20.3|<0.0001
72587919|NCT02016105|144706477|EQUIVALENCE|LSM, SE and 95% CI were estimated using an ANCOVA model with treatment, body weight strata, region and prior systemic therapy as fixed effects and baseline PASI score as covariate. Therapeutic equivalence in terms of the % change from baseline in PASI score was to be determined if the 95% CI for the difference between GP2017 and Humira was contained within the interval \[-15%; 15%\].|LS means difference|1.2|STANDARD_ERROR_OF_MEAN|2.0|||TWO_SIDED|95.0|-2.78|5.08||||||||5.08|-2.78|
72587920|NCT01908829|144706503|SUPERIORITY||Least Squares (LS) Means|-0.26|STANDARD_ERROR_OF_MEAN|0.11|=|0.001|TWO_SIDED|95.0|-0.47|-0.05||P values for pairwise comparisons were from the stratified rank ANCOVA model. P \< 0.05 indicated superiority in favor of treatment group with the largest improvement.|stratified rank ANCOVA|||Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group based on ANCOVA model. Means (LS means) and 95% Confidence Intervals (CIs) are from an ANCOVA model with sex, age group (\< 65, ≥ 65 years), geographic region, and 4-week incontinence episode reduction group as fixed factors and mean number of incontinence episodes per 24 hours at baseline as a covariate.||-0.05|-0.47|=0.001
72587921|NCT01908829|144706504|SUPERIORITY||LS Means|-0.33|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.52|-0.14||P values for pairwise comparisons are from the stratified rank ANCOVA model. P \< 0.05 indicates superiority in favor of treatment group with the largest improvement.|stratified rank ANCOVA|||Week 4 differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group based on ANCOVA model. Means (LS means) and 95% CIs are from an ANCOVA model with sex, age group (\< 65, ≥ 65 years), geographic region, and 4-week incontinence episode reduction group as fixed factors and mean number of incontinence episodes per 24 hours at baseline as a covariate.||-0.14|-0.52|<0.001
72587922|NCT01908829|144706504|SUPERIORITY||LS Means|-0.39|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.6|-0.18||P values for pairwise comparisons are from the stratified rank ANCOVA model. P \< 0.05 indicates superiority in favor of treatment group with the largest improvement.|stratified rank ANCOVA|||Week 8 differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group based on ANCOVA model. Means (LS means) and 95% CIs are from an ANCOVA model with sex, age group (\< 65, ≥ 65 years), geographic region, and 4-week incontinence episode reduction group as fixed factors and mean number of incontinence episodes per 24 hours at baseline as a covariate.||-0.18|-0.60|<0.001
72587923|NCT01908829|144706504|SUPERIORITY||LS Means|-0.25|STANDARD_ERROR_OF_MEAN|0.11|=|0.001|TWO_SIDED|95.0|-0.46|-0.03||P-values for pairwise comparisons are from the stratified rank ANCOVA model. p\<0.05 indicates superiority in favor of treatment group with the largest improvement.|stratified rank ANCOVA|||Week 12 differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group based on ANCOVA model. Means (LS means) and 95% CIs are from an ANCOVA model with sex, age group (\< 65, ≥ 65 years), geographic region, and 4-week incontinence episode reduction group as fixed factors and mean number of incontinence episodes per 24 hours at baseline as a covariate.||-0.03|-0.46|=0.001
72587924|NCT01908829|144706505|SUPERIORITY||LS Means|-0.26|STANDARD_ERROR_OF_MEAN|0.1|=|0.01|TWO_SIDED|95.0|-0.47|-0.06||P-values for pairwise comparisons are from the ANCOVA model described above. p\<0.05 indicates superiority in favor of treatment group with the largest improvement.|ANCOVA|||Week 4 adjusted change from baseline values as well as 95% CIs and p-value were generated from an ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors and baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||-0.06|-0.47|=0.010
72587925|NCT01908829|144706505|SUPERIORITY||LS Means|-0.42|STANDARD_ERROR_OF_MEAN|0.12|<|0.001|TWO_SIDED|95.0|-0.65|-0.19||P-values for pairwise comparisons are from the ANCOVA model described above. p\<0.05 indicates superiority in favor of treatment group with the largest improvement.|ANCOVA|||Week 8 adjusted change from baseline values as well as 95% CIs and p-value were generated from an ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors and baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||-0.19|-0.65|<0.001
72414045|NCT01458574|144337113|SUPERIORITY_OR_OTHER||Difference in percentage|21.2|||<|0.0001|TWO_SIDED|95.0|14.1|28.3|||CMH chi-square test|||P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||28.3|14.1|<0.0001
72587926|NCT01908829|144706505|SUPERIORITY||LS Means|-0.47|STANDARD_ERROR_OF_MEAN|0.12|<|0.001|TWO_SIDED|95.0|-0.7|-0.23||P-values for pairwise comparisons are from the ANCOVA model described above. p\<0.05 indicates superiority in favor of treatment group with the largest improvement.|ANCOVA|||Week 12 adjusted change from baseline values as well as 95% CIs and p-value were generated from an ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors and baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||-0.23|-0.70|<0.001
72587927|NCT01908829|144706505|SUPERIORITY||LS Means|-0.45|STANDARD_ERROR_OF_MEAN|0.12|<|0.001|TWO_SIDED|95.0|-0.67|-0.22||P-values for pairwise comparisons are from the ANCOVA model described above. p\<0.05 indicates superiority in favor of treatment group with the largest improvement.|ANCOVA|||EoT adjusted change from baseline values as well as 95% CIs and p-value were generated from an ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors and baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||-0.22|-0.67|<0.001
72587928|NCT01908829|144706506|SUPERIORITY||Rate Ratio|0.87|STANDARD_ERROR_OF_MEAN|0.05|=|0.005|TWO_SIDED|95.0|0.79|0.96||p\<0.05 indicates superiority in favor of treatment group with lowest rate of incontinence episodes.|Mixed Effects Poisson|||Week 4 rate ratio, 95% CIs, \& p-value for number of incontinence episodes (IEs) during Week 4 3-day diary between combination \& solifenacin treatment was calculated from Mixed Effects Poisson (negative binomial) regression model including treatment group, sex, age group (\<65, \>=65 years), geographic region \& 4-week IE reduction group as factors, log of (number of IEs/valid diary days) at baseline as covariate \& log of number of valid diary days as the offset variable.||0.96|0.79|=0.005
72587929|NCT01908829|144706506|SUPERIORITY||Rate Ratio|0.75|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|95.0|0.66|0.86||p\<0.05 indicates superiority in favor of treatment group with lowest rate of incontinence episodes.|Mixed Effects Poisson|||Week 8 rate ratio, 95% CIs, \& p-value for number of incontinence episodes (IEs) during Week 8 3-day diary between combination \& solifenacin treatment was calculated from Mixed Effects Poisson (negative binomial) regression model including treatment group, sex, age group (\<65, \>=65 years), geographic region \& 4-week IE reduction group as factors, log of (number of IEs/valid diary days) at baseline as covariate \& log of number of valid diary days as the offset variable.||0.86|0.66|<0.001
72587930|NCT01908829|144706506|SUPERIORITY||Rate Ratio|0.82|STANDARD_ERROR_OF_MEAN|0.08|=|0.021|TWO_SIDED|95.0|0.7|0.97||p\<0.05 indicates superiority in favor of treatment group with lowest rate of incontinence episodes.|Mixed Effects Poisson|||Week 12 rate ratio, 95% CIs, \& p-value for number of incontinence episodes (IEs) during Week 12 3-day diary between combination \& solifenacin treatment was calculated from Mixed Effects Poisson (negative binomial) regression model including treatment group, sex, age group (\<65, \>=65 years), geographic region \& 4-week IE reduction group as factors, log of (number of IEs/valid diary days) at baseline as covariate \& log of number of valid diary days as the offset variable.||0.97|0.70|=0.021
72587931|NCT01908829|144706506|SUPERIORITY||Rate Ratio|0.82|STANDARD_ERROR_OF_MEAN|0.08|=|0.014|TWO_SIDED|95.0|0.71|0.96||p\<0.05 indicates superiority in favor of treatment group with lowest rate of incontinence episodes.|Mixed Effects Poisson|||EoT rate ratio, 95% CIs, \& p-value for number of incontinence episodes (IEs) during EoT 3-day diary between combination \& solifenacin treatment was calculated from Mixed Effects Poisson (negative binomial) regression model including treatment group, sex, age group (\<65, \>=65 years), geographic region \& 4-week IE reduction group as factors, log of (number of IEs/valid diary days) at baseline as covariate \& log of number of valid diary days as the offset variable.||0.96|0.71|=0.014
72587932|NCT01908829|144706507|SUPERIORITY||LS Means|3.86|STANDARD_ERROR_OF_MEAN|2.19|<|0.078|TWO_SIDED|95.0|-0.43|8.16||P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicates superiority in favor of treatment group with the largest improvement.|ANCOVA|||Week 4 adjusted change from baseline values as well as 95% CIs and p-value were generated from an ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors and baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||8.16|-0.43|<0.078
72587933|NCT01908829|144706507|SUPERIORITY||LS Means|11.19|STANDARD_ERROR_OF_MEAN|2.66|<|0.001|TWO_SIDED|95.0|5.98|16.4||P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicates superiority in favor of treatment group with the largest improvement.|ANCOVA|||Week 8 adjusted change from baseline values as well as 95% CIs and p-value were generated from an ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors and baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||16.40|5.98|<0.001
72587934|NCT01908829|144706507|SUPERIORITY||LS Means|12.38|STANDARD_ERROR_OF_MEAN|2.92|<|0.001|TWO_SIDED|95.0|6.65|18.12||P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicates superiority in favor of treatment group with the largest improvement.|ANCOVA|||Week 12 adjusted change from baseline values as well as 95% CIs and p-value were generated from an ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors and baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||18.12|6.65|<0.001
72587935|NCT01908829|144706507|SUPERIORITY||LS Means|11.52|STANDARD_ERROR_OF_MEAN|2.79|<|0.001|TWO_SIDED|95.0|6.06|16.99||P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicates superiority in favor of treatment group with the largest improvement.|ANCOVA|||EoT adjusted change from baseline values as well as 95% CIs and p-value were generated from an ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors and baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||16.99|6.06|<0.001
72587936|NCT01908829|144706508|SUPERIORITY||LS Means|-0.44|STANDARD_ERROR_OF_MEAN|0.15|=|0.003|TWO_SIDED|95.0|-0.73|-0.16||P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicates superiority in favor of treatment group with the largest improvement.|ANCOVA|||Adjusted change from baseline values as well as 95% CIs and p-value were generated from an ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors and baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||-0.16|-0.73|=0.003
72587937|NCT01908829|144706509|SUPERIORITY||LS Means|-0.35|STANDARD_ERROR_OF_MEAN|0.09|<|0.001|TWO_SIDED|95.0|-0.54|-0.17||P-values for pairwise comparisons were from stratified rank ANCOVA model. p\<0.05 indicates superiority in favor of treatment group with the largest improvement.|stratified rank ANCOVA|||Week 4 adjusted change from baseline values as well as 95% CIs were generated from an ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors and baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||-0.17|-0.54|<0.001
72587938|NCT01908829|144706509|SUPERIORITY||LS Means|-0.45|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.65|-0.25||P-values for pairwise comparisons were from stratified rank ANCOVA model. p\<0.05 indicates superiority in favor of treatment group with the largest improvement.|stratified rank ANCOVA|||Week 8 djusted change from baseline values as well as 95% CIs were generated from an ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors and baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||-0.25|-0.65|<0.001
72587939|NCT01908829|144706509|SUPERIORITY||LS Means|-0.26|STANDARD_ERROR_OF_MEAN|0.11|=|0.004|TWO_SIDED|95.0|-0.47|-0.05||P-values for pairwise comparisons were from stratified rank ANCOVA model. p\<0.05 indicates superiority in favor of treatment group with the largest improvement.|stratified rank ANCOVA|||Week 12 adjusted change from baseline values as well as 95% CIs were generated from an ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors and baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||-0.05|-0.47|=0.004
72587940|NCT01908829|144706509|SUPERIORITY||LS Means|-0.27|STANDARD_ERROR_OF_MEAN|0.1|=|0.003|TWO_SIDED|95.0|-0.47|-0.07||P-values for pairwise comparisons were from stratified rank ANCOVA model. p\<0.05 indicates superiority in favor of treatment group with the largest improvement.|stratified rank ANCOVA|||EoT adjusted change from baseline values as well as 95% CIs were generated from an ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors and baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||-0.07|-0.47|=0.003
72587941|NCT01908829|144706510|SUPERIORITY||Rate Ratio|0.85|STANDARD_ERROR_OF_MEAN|0.05|=|0.003|TWO_SIDED|95.0|0.76|0.94||p\<0.05 indicates superiority in favor of treatment group with lowest rate of UI episodes.|Mixed Effects Poisson|||Week 4 rate ratio, 95% CIs, and p-value for number of UI episodes during Week 4 3-day diary between combination and solifenacin treatment was calculated from a Mixed Effects Poisson (negative binomial) regression model including treatment group, sex, age group (\<65, \>=65 years), geographic region and 4-week incontinence episode reduction group as factors, log of (number of UI episodes/number of valid diary days) at baseline as covariate and log of number of valid diary as the offset variable.||0.94|0.76|=0.003
72587942|NCT01908829|144706510|SUPERIORITY||Rate Ratio|0.74|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|0.63|0.86||p\<0.05 indicates superiority in favor of treatment group with lowest rate of UI episodes.|Mixed Effects Poisson|||Week 8 rate ratio, 95% CIs, and p-value for number of UI episodes during Week 8 3-day diary between combination and solifenacin treatment was calculated from a Mixed Effects Poisson (negative binomial) regression model including treatment group, sex, age group (\<65, \>=65 years), geographic region and 4-week incontinence episode reduction group as factors, log of (number of UI episodes/number of valid diary days) at baseline as covariate and log of number of valid diary as the offset variable.||0.86|0.63|<0.001
72587943|NCT01908829|144706510|SUPERIORITY||Rate Ratio|0.83|STANDARD_ERROR_OF_MEAN|0.09|=|0.038|TWO_SIDED|95.0|0.69|0.99||p\<0.05 indicates superiority in favor of treatment group with lowest rate of UI episodes.|Mixed Effects Poisson|||Week 12 rate ratio, 95% CIs, and p-value for number of UI episodes during Week 12 3-day diary between combination and solifenacin treatment was calculated from a Mixed Effects Poisson (negative binomial) regression model including treatment group, sex, age group (\<65, \>=65 years), geographic region and 4-week incontinence episode reduction group as factors, log of (number of UI episodes/number of valid diary days) at baseline as covariate and log of number of valid diary as the offset variable.||0.99|0.69|=0.038
72587944|NCT01908829|144706510|SUPERIORITY||Rate Ratio|0.82|STANDARD_ERROR_OF_MEAN|0.09|=|0.022|TWO_SIDED|95.0|0.69|0.97||p\<0.05 indicates superiority in favor of treatment group with lowest rate of UI episodes.|Mixed Effects Poisson|||EoT rate ratio, 95% CIs, and p-value for number of UI episodes during EoT 3-day diary between combination and solifenacin treatment was calculated from a Mixed Effects Poisson (negative binomial) regression model including treatment group, sex, age group (\<65, \>=65 years), geographic region and 4-week incontinence episode reduction group as factors, log of (number of UI episodes/number of valid diary days) at baseline as covariate and log of number of valid diary as the offset variable.||0.97|0.69|=0.022
72587945|NCT01908829|144706511|SUPERIORITY||LS Means|-0.45|STANDARD_ERROR_OF_MEAN|0.13|=|0.001|TWO_SIDED|95.0|-0.72|-0.19||P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicates superiority in favor of treatment group with the largest improvement.|ANCOVA|||Week 4 adjusted change from baseline values as well as 95% CIs were generated from an ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors and baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||-0.19|-0.72|=0.001
72587946|NCT01908829|144706511|SUPERIORITY||LS Means|-0.64|STANDARD_ERROR_OF_MEAN|0.15|<|0.001|TWO_SIDED|95.0|-0.93|-0.35||P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicates superiority in favor of treatment group with the largest improvement.|ANCOVA|||Week 8 adjusted change from baseline values as well as 95% CIs were generated from an ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors and baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||-0.35|-0.93|<0.001
72587947|NCT01908829|144706511|SUPERIORITY||LS Means|-0.52|STANDARD_ERROR_OF_MEAN|0.15|=|0.001|TWO_SIDED|95.0|-0.82|-0.22||P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicates superiority in favor of treatment group with the largest improvement.|ANCOVA|||Week 12 adjusted change from baseline values as well as 95% CIs were generated from an ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors and baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||-0.22|-0.82|=0.001
72587948|NCT01908829|144706511|SUPERIORITY||LS Means|-0.54|STANDARD_ERROR_OF_MEAN|0.15|<|0.001|TWO_SIDED|95.0|-0.83|-0.25||P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicates superiority in favor of treatment group with the largest improvement.|ANCOVA|||EoT adjusted change from baseline values as well as 95% CIs were generated from an ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors and baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||-0.25|-0.83|<0.001
72587949|NCT01908829|144706512|SUPERIORITY||LS Means|-0.26|STANDARD_ERROR_OF_MEAN|0.1|=|0.008|TWO_SIDED|95.0|-0.46|-0.07||P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicates superiority in favor of treatment group with the largest improvement.|ANCOVA|||Week 4 adjusted change from baseline values as well as 95% CIs were generated from an ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group \& geographic region as fixed factors and baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||-0.07|-0.46|=0.008
72587950|NCT01908829|144706512|SUPERIORITY||LS Means|-0.34|STANDARD_ERROR_OF_MEAN|0.11|=|0.002|TWO_SIDED|95.0|-0.55|-0.13||P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicates superiority in favor of treatment group with the largest improvement.|ANCOVA|||Week 8 adjusted change from baseline values as well as 95% CIs were generated from an ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group \& geographic region as fixed factors and baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||-0.13|-0.55|=0.002
72587951|NCT01908829|144706512|SUPERIORITY||LS Means|-0.28|STANDARD_ERROR_OF_MEAN|0.1|=|0.006|TWO_SIDED|95.0|-0.47|-0.08||P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicates superiority in favor of treatment group with the largest improvement.|ANCOVA|||Week 12 adjusted change from baseline values as well as 95% CIs were generated from an ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group \& geographic region as fixed factors and baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||-0.08|-0.47|=0.006
72587952|NCT01908829|144706512|SUPERIORITY||LS Means|-0.31|STANDARD_ERROR_OF_MEAN|0.1|=|0.002|TWO_SIDED|95.0|-0.51|-0.12||P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicates superiority in favor of treatment group with the largest improvement.|ANCOVA|||EoT adjusted change from baseline values as well as 95% CIs were generated from an ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group \& geographic region as fixed factors and baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||-0.12|-0.51|=0.002
72587953|NCT01908829|144706513|SUPERIORITY||Rate Ratio|0.97|STANDARD_ERROR_OF_MEAN|0.06|=|0.545|TWO_SIDED|95.0|0.87|1.08||p\<0.05 indicates superiority in favor of treatment group with lowest rate of pads used.|Mixed Effects Poisson|||Week 4 rate ratio, 95% CIs, and p-value for number of pads used during the 3-day diary between combination \& solifenacin treatment was calculated from a Mixed Effects Poisson (negative binomial) regression model including treatment group, sex, age group (\<65, \>=65 years), geographic region and 4-week incontinence episode reduction group as factors, log of (number of pads used/number of valid diary days) at baseline as covariate and log of number of valid diary days as the offset variable.||1.08|0.87|=0.545
72587954|NCT01908829|144706513|SUPERIORITY||Rate Ratio|0.82|STANDARD_ERROR_OF_MEAN|0.08|=|0.01|TWO_SIDED|95.0|0.7|0.95||p\<0.05 indicates superiority in favor of treatment group with lowest rate of pads used.|Mixed Effects Poisson|||Week 8 rate ratio, 95% CIs, and p-value for number of pads used during the 3-day diary between combination \& solifenacin treatment was calculated from a Mixed Effects Poisson (negative binomial) regression model including treatment group, sex, age group (\<65, \>=65 years), geographic region and 4-week incontinence episode reduction group as factors, log of (number of pads used/number of valid diary days) at baseline as covariate and log of number of valid diary days as the offset variable.||0.95|0.70|=0.010
72587955|NCT01908829|144706513|SUPERIORITY||Rate Ratio|0.79|STANDARD_ERROR_OF_MEAN|0.09|=|0.007|TWO_SIDED|95.0|0.67|0.94||p\<0.05 indicates superiority in favor of treatment group with lowest rate of pads used.|Mixed Effects Poisson|||Week 12 rate ratio, 95% CIs, and p-value for number of pads used during the 3-day diary between combination \& solifenacin treatment was calculated from a Mixed Effects Poisson (negative binomial) regression model including treatment group, sex, age group (\<65, \>=65 years), geographic region and 4-week incontinence episode reduction group as factors, log of (number of pads used/number of valid diary days) at baseline as covariate and log of number of valid diary days as the offset variable.||0.94|0.67|=0.007
72587956|NCT01908829|144706513|SUPERIORITY||Rate Ratio|0.78|STANDARD_ERROR_OF_MEAN|0.08|=|0.003|TWO_SIDED|95.0|0.66|0.92||p\<0.05 indicates superiority in favor of treatment group with lowest rate of pads used.|Mixed Effects Poisson|||EoT rate ratio, 95% CIs, and p-value for number of pads used during the 3-day diary between combination \& solifenacin treatment was calculated from a Mixed Effects Poisson (negative binomial) regression model including treatment group, sex, age group (\<65, \>=65 years), geographic region and 4-week incontinence episode reduction group as factors, log of (number of pads used/number of valid diary days) at baseline as covariate and log of number of valid diary days as the offset variable.||0.92|0.66|=0.003
72587957|NCT01908829|144706514|SUPERIORITY||LS Means|-0.01|STANDARD_ERROR_OF_MEAN|0.05|=|0.836|TWO_SIDED|95.0|-0.1|0.08||P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicates superiority in favor of treatment group with the largest improvement.|ANCOVA|||Week 4 adjusted change from baseline values as well as 95% CIs and p-value were generated from an ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors and baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||0.08|-0.10|=0.836
72587958|NCT01908829|144706514|SUPERIORITY||LS Means|-0.02|STANDARD_ERROR_OF_MEAN|0.05|=|0.617|TWO_SIDED|95.0|-0.12|0.07||P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicates superiority in favor of treatment group with the largest improvement.|ANCOVA|||Week 8 adjusted change from baseline values as well as 95% CIs and p-value were generated from an ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors and baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||0.07|-0.12|=0.617
72587959|NCT01908829|144706514|SUPERIORITY||LS Means|-0.07|STANDARD_ERROR_OF_MEAN|0.05|=|0.134|TWO_SIDED|95.0|-0.17|0.02||P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicates superiority in favor of treatment group with the largest improvement.|ANCOVA|||Week 12 adjusted change from baseline values as well as 95% CIs and p-value were generated from an ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors and baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||0.02|-0.17|=0.134
72587960|NCT01908829|144706514|SUPERIORITY||LS Means|-0.06|STANDARD_ERROR_OF_MEAN|0.05|=|0.174|TWO_SIDED|95.0|-0.16|0.03||P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicates superiority in favor of treatment group with the largest improvement.|ANCOVA|||EOT adjusted change from baseline values as well as 95% CIs and p-value were generated from an ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors and baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||0.03|-0.16|=0.174
72587961|NCT01908829|144706515|SUPERIORITY||Rate Ratio|1.0|STANDARD_ERROR_OF_MEAN|0.04|=|0.993|TWO_SIDED|95.0|0.93|1.08||p\<0.05 indicates superiority in favor of treatment group with lowest rate of nocturia episodes.|Mixed Effects Poisson|||Week 4 rate ratio, 95% CIs, \& p-value for number of nocturia episodes during 3-day diary between combination \& solifenacin treatment calculated from a Mixed Effects Poisson (negative binomial) regression model including treatment group, sex, age group (\<65, \>=65 years), geographic region \& 4-week incontinence episode reduction group as factors, log of (number of nocturia episodes/number of valid diary days) at baseline as covariate and log of number of valid diary days as the offset variable.||1.08|0.93|=0.993
72587962|NCT01908829|144706515|SUPERIORITY||Rate Ratio|0.99|STANDARD_ERROR_OF_MEAN|0.04|=|0.736|TWO_SIDED|95.0|0.9|1.07||p\<0.05 indicates superiority in favor of treatment group with lowest rate of nocturia episodes.|Mixed Effects Poisson|||Week 8 rate ratio, 95% CIs, \& p-value for number of nocturia episodes during 3-day diary between combination \& solifenacin treatment calculated from a Mixed Effects Poisson (negative binomial) regression model including treatment group, sex, age group (\<65, \>=65 years), geographic region \& 4-week incontinence episode reduction group as factors, log of (number of nocturia episodes/number of valid diary days) at baseline as covariate and log of number of valid diary days as the offset variable.||1.07|0.90|=0.736
72587963|NCT01908829|144706515|SUPERIORITY||Rate Ratio|0.93|STANDARD_ERROR_OF_MEAN|0.05|=|0.121|TWO_SIDED|95.0|0.85|1.02||p\<0.05 indicates superiority in favor of treatment group with lowest rate of nocturia episodes.|Mixed Effects Poisson|||Week 12 rate ratio, 95% CIs, \& p-value for number of nocturia episodes during 3-day diary between combination \& solifenacin treatment calculated from a Mixed Effects Poisson (negative binomial) regression model including treatment group, sex, age group (\<65, \>=65 years), geographic region \& 4-week incontinence episode reduction group as factors, log of (number of nocturia episodes/number of valid diary days) at baseline as covariate and log of number of valid diary days as the offset variable.||1.02|0.85|=0.121
72587964|NCT01908829|144706515|SUPERIORITY||Rate Ratio|0.94|STANDARD_ERROR_OF_MEAN|0.04|=|0.172|TWO_SIDED|95.0|0.86|1.03||p\<0.05 indicates superiority in favor of treatment group with lowest rate of nocturia episodes.|Mixed Effects Poisson|||EoT rate ratio, 95% CIs, \& p-value for number of nocturia episodes during 3-day diary between combination \& solifenacin treatment calculated from a Mixed Effects Poisson (negative binomial) regression model including treatment group, sex, age group (\<65, \>=65 years), geographic region \& 4-week incontinence episode reduction group as factors, log of (number of nocturia episodes/number of valid diary days) at baseline as covariate and log of number of valid diary days as the offset variable.||1.03|0.86|=0.172
72587965|NCT01908829|144706521|SUPERIORITY||LS Means|-2.89|STANDARD_ERROR_OF_MEAN|0.91|=|0.002|TWO_SIDED|95.0|-4.68|-1.1||P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicated superiority in favor of treatment group with the largest improvement.|ANCOVA|||Week 4 adjusted change from baseline values as well as 95% CIs \& p-value were generated from ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors \& baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||-1.10|-4.68|=0.002
72587966|NCT01908829|144706521|SUPERIORITY||LS Means|-4.5|STANDARD_ERROR_OF_MEAN|0.97|<|0.001|TWO_SIDED|95.0|-6.4|-2.6||P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicated superiority in favor of treatment group with the largest improvement.|ANCOVA|||Week 8 adjusted change from baseline values as well as 95% CIs \& p-value were generated from ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors \& baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||-2.60|-6.40|<0.001
72587967|NCT01908829|144706521|SUPERIORITY||LS Means|-5.59|STANDARD_ERROR_OF_MEAN|1.0|<|0.001|TWO_SIDED|95.0|-7.56|-3.62||P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicated superiority in favor of treatment group with the largest improvement.|ANCOVA|||Week 12 adjusted change from baseline values as well as 95% CIs \& p-value were generated from ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors \& baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||-3.62|-7.56|<0.001
72587968|NCT01908829|144706521|SUPERIORITY||LS Means|-4.96|STANDARD_ERROR_OF_MEAN|0.98|<|0.001|TWO_SIDED|95.0|-6.88|-3.04||P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicated superiority in favor of treatment group with the largest improvement.|ANCOVA|||EoT adjusted change from baseline values as well as 95% CIs \& p-value were generated from ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors \& baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||-3.04|-6.88|<0.001
72587969|NCT01908829|144706522|SUPERIORITY||LS Means|1.92|STANDARD_ERROR_OF_MEAN|0.83|=|0.021|TWO_SIDED|95.0|0.29|3.55||P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicated superiority in favor of treatment group with the largest improvement.|ANCOVA|||Week 4 adjusted change from baseline values as well as 95% CIs \& p-value were generated from ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors \& baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||3.55|0.29|=0.021
72587970|NCT01908829|144706522|SUPERIORITY||LS Means|2.31|STANDARD_ERROR_OF_MEAN|0.89|=|0.01|TWO_SIDED|95.0|0.56|4.06||P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicated superiority in favor of treatment group with the largest improvement.|ANCOVA|||Week 8 adjusted change from baseline values as well as 95% CIs \& p-value were generated from ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors \& baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||4.06|0.56|=0.010
72587971|NCT01908829|144706522|SUPERIORITY||LS Means|3.49|STANDARD_ERROR_OF_MEAN|0.94|<|0.001|TWO_SIDED|95.0|1.65|5.33||P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicated superiority in favor of treatment group with the largest improvement.|ANCOVA|||Week 12 adjusted change from baseline values as well as 95% CIs \& p-value were generated from ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors \& baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||5.33|1.65|<0.001
72587972|NCT01908829|144706522|SUPERIORITY||LS Means|3.15|STANDARD_ERROR_OF_MEAN|0.92|=|0.001|TWO_SIDED|95.0|1.35|4.95||P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicated superiority in favor of treatment group with the largest improvement.|ANCOVA|||EoT adjusted change from baseline values as well as 95% CIs \& p-value were generated from ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors \& baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||4.95|1.35|=0.001
72587973|NCT01908829|144706523|SUPERIORITY||LS Means|2.9|STANDARD_ERROR_OF_MEAN|0.96|=|0.003|TWO_SIDED|95.0|1.02|4.78||P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicated superiority in favor of treatment group with the largest improvement.|ANCOVA|||Week 4 adjusted change from baseline values as well as 95% CIs \& p-value were generated from ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors \& baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||4.78|1.02|=0.003
72587974|NCT01908829|144706523|SUPERIORITY||LS Means|3.35|STANDARD_ERROR_OF_MEAN|1.05|=|0.001|TWO_SIDED|95.0|1.29|5.4||P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicated superiority in favor of treatment group with the largest improvement.|ANCOVA|||Week 8 adjusted change from baseline values as well as 95% CIs \& p-value were generated from ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors \& baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||5.40|1.29|=0.001
72587975|NCT01908829|144706523|SUPERIORITY||LS Means|4.71|STANDARD_ERROR_OF_MEAN|1.1|<|0.001|TWO_SIDED|95.0|2.55|6.87||P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicated superiority in favor of treatment group with the largest improvement.|ANCOVA|||Week 12 adjusted change from baseline values as well as 95% CIs \& p-value were generated from ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors \& baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||6.87|2.55|<0.001
72587976|NCT01908829|144706523|SUPERIORITY||LS Means|4.29|STANDARD_ERROR_OF_MEAN|1.07|<|0.001|TWO_SIDED|95.0|2.2|6.39||P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicated superiority in favor of treatment group with the largest improvement.|ANCOVA|||EoT adjusted change from baseline values as well as 95% CIs \& p-value were generated from ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors \& baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||6.39|2.20|<0.001
72587977|NCT01908829|144706524|SUPERIORITY||LS Means|1.94|STANDARD_ERROR_OF_MEAN|0.96|=|0.044|TWO_SIDED|95.0|0.05|3.83||P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicated superiority in favor of treatment group with the largest improvement.|ANCOVA|||Week 4 adjusted change from baseline values as well as 95% CIs \& p-value were generated from ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors \& baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||3.83|0.05|=0.044
72587978|NCT01908829|144706524|SUPERIORITY||LS Means|2.5|STANDARD_ERROR_OF_MEAN|1.0|=|0.012|TWO_SIDED|95.0|0.55|4.46||P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicated superiority in favor of treatment group with the largest improvement.|ANCOVA|||Week 8 adjusted change from baseline values as well as 95% CIs \& p-value were generated from ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors \& baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||4.46|0.55|=0.012
72587979|NCT01908829|144706524|SUPERIORITY||LS Means|3.61|STANDARD_ERROR_OF_MEAN|1.05|=|0.001|TWO_SIDED|95.0|1.54|5.67||P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicated superiority in favor of treatment group with the largest improvement.|ANCOVA|||Week 12 adjusted change from baseline values as well as 95% CIs \& p-value were generated from ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors \& baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||5.67|1.54|=0.001
72587980|NCT01908829|144706524|SUPERIORITY||LS Means|3.28|STANDARD_ERROR_OF_MEAN|1.03|=|0.001|TWO_SIDED|95.0|1.27|5.29||P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicated superiority in favor of treatment group with the largest improvement.|ANCOVA|||EoT adjusted change from baseline values as well as 95% CIs \& p-value were generated from ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors \& baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||5.29|1.27|=0.001
72587981|NCT01908829|144706525|SUPERIORITY||LS Means|0.54|STANDARD_ERROR_OF_MEAN|0.96|=|0.575|TWO_SIDED|95.0|-1.35|2.43||P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicated superiority in favor of treatment group with the largest improvement.|ANCOVA|||Week 4 adjusted change from baseline values as well as 95% CIs \& p-value were generated from ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors \& baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||2.43|-1.35|=0.575
72587982|NCT01908829|144706525|SUPERIORITY||LS Means|1.61|STANDARD_ERROR_OF_MEAN|1.0|=|0.109|TWO_SIDED|95.0|-0.36|3.58||P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicated superiority in favor of treatment group with the largest improvement.|ANCOVA|||Week 8 adjusted change from baseline values as well as 95% CIs \& p-value were generated from ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors \& baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||3.58|-0.36|=0.109
72587983|NCT01908829|144706525|SUPERIORITY||LS Means|2.26|STANDARD_ERROR_OF_MEAN|1.05|=|0.032|TWO_SIDED|95.0|0.2|4.32||P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicated superiority in favor of treatment group with the largest improvement.|ANCOVA|||Week 12 adjusted change from baseline values as well as 95% CIs \& p-value were generated from ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors \& baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||4.32|0.20|=0.032
72587984|NCT01908829|144706525|SUPERIORITY||LS Means|1.86|STANDARD_ERROR_OF_MEAN|1.02|=|0.069|TWO_SIDED|95.0|-0.15|3.87||P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicated superiority in favor of treatment group with the largest improvement.|ANCOVA|||EoT adjusted change from baseline values as well as 95% CIs \& p-value were generated from ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors \& baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||3.87|-0.15|=0.069
72587985|NCT01908829|144706526|SUPERIORITY||LS Means|1.73|STANDARD_ERROR_OF_MEAN|0.83|=|0.037|TWO_SIDED|95.0|0.1|3.36||P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicated superiority in favor of treatment group with the largest improvement.|ANCOVA|||Week 4 adjusted change from baseline values as well as 95% CIs \& p-value were generated from ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors \& baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||3.36|0.10|=0.037
72587986|NCT01908829|144706526|SUPERIORITY||LS Means|1.09|STANDARD_ERROR_OF_MEAN|0.85|=|0.199|TWO_SIDED|95.0|-0.57|2.76||P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicated superiority in favor of treatment group with the largest improvement.|ANCOVA|||Week 8 adjusted change from baseline values as well as 95% CIs \& p-value were generated from ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors \& baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||2.76|-0.57|=0.199
72587987|NCT01908829|144706526|SUPERIORITY||LS Means|2.62|STANDARD_ERROR_OF_MEAN|0.87|=|0.003|TWO_SIDED|95.0|0.92|4.31||P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicated superiority in favor of treatment group with the largest improvement.|ANCOVA|||Week 12 adjusted change from baseline values as well as 95% CIs \& p-value were generated from ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors \& baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||4.31|0.92|=0.003
72587988|NCT01908829|144706526|SUPERIORITY||LS Means|2.48|STANDARD_ERROR_OF_MEAN|0.85|=|0.004|TWO_SIDED|95.0|0.81|4.15||P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicated superiority in favor of treatment group with the largest improvement.|ANCOVA|||EoT adjusted change from baseline values as well as 95% CIs \& p-value were generated from ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors \& baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||4.15|0.81|=0.004
72587989|NCT01908829|144706527|SUPERIORITY||LS Means|0.4|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|0.2|0.6||P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicated superiority in favor of treatment group with the largest improvement.|ANCOVA|||Week 4 adjusted change from baseline values as well as the 95% CIs and p-value were generated from an ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors and baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||0.6|0.2|<0.001
72587990|NCT01908829|144706527|SUPERIORITY||LS Means|0.3|STANDARD_ERROR_OF_MEAN|0.1|=|0.019|TWO_SIDED|95.0|0.0|0.5||P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicated superiority in favor of treatment group with the largest improvement.|ANCOVA|||Week 8 adjusted change from baseline values as well as the 95% CIs and p-value were generated from an ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors and baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||0.5|0.0|=0.019
72587991|NCT01908829|144706527|SUPERIORITY||LS Means|0.5|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|0.3|0.7||P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicated superiority in favor of treatment group with the largest improvement.|ANCOVA|||Week 12 adjusted change from baseline values as well as the 95% CIs and p-value were generated from an ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors and baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||0.7|0.3|<0.001
72587992|NCT01908829|144706527|SUPERIORITY||LS Means|0.4|STANDARD_ERROR_OF_MEAN|0.1|=|0.001|TWO_SIDED|95.0|0.2|0.6||P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicated superiority in favor of treatment group with the largest improvement.|ANCOVA|||EoT adjusted change from baseline values as well as the 95% CIs and p-value were generated from an ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors and baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||0.6|0.2|=0.001
72587993|NCT01908829|144706528|SUPERIORITY||LS Means|-0.2|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.4|-0.1||P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicated superiority in favor of treatment group with the largest improvement.|ANCOVA|||Week 4 adjusted change from baseline values as well as the 95% CIs and p-value were generated from ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors and baseline value as a covariate. Difference of adjusted mean was calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||-0.1|-0.4|<0.001
72587994|NCT01908829|144706528|SUPERIORITY||LS Means|-0.2|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.4|-0.1||P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicated superiority in favor of treatment group with the largest improvement.|ANCOVA|||Week 8 adjusted change from baseline values as well as the 95% CIs and p-value were generated from ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors and baseline value as a covariate. Difference of adjusted mean was calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||-0.1|-0.4|<0.001
72587995|NCT01908829|144706528|SUPERIORITY||LS Means|-0.3|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.4|-0.2||P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicated superiority in favor of treatment group with the largest improvement.|ANCOVA|||Week 12 adjusted change from baseline values as well as the 95% CIs and p-value were generated from ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors and baseline value as a covariate. Difference of adjusted mean was calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||-0.2|-0.4|<0.001
72414046|NCT01458574|144337113|SUPERIORITY_OR_OTHER||Difference in percentage|26.4|||<|0.0001|TWO_SIDED|95.0|19.0|33.8|||CMH chi-square test|||P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||33.8|19.0|<0.0001
72414047|NCT01458574|144337114|SUPERIORITY_OR_OTHER||Difference in percentage|30.6|||<|0.0001|TWO_SIDED|95.0|18.1|43.1|||CMH chi-square test|||At Week 24: P-value based on CMH chi-square test stratified by induction study treatment. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||43.1|18.1|<0.0001
72587996|NCT01908829|144706528|SUPERIORITY||LS Means|-0.3|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.4|-0.1||P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicated superiority in favor of treatment group with the largest improvement.|ANCOVA|||EoT adjusted change from baseline values as well as the 95% CIs and p-value were generated from ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors and baseline value as a covariate. Difference of adjusted mean was calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||-0.1|-0.4|<0.001
72587997|NCT01908829|144706530|SUPERIORITY||Odds Ratio (OR)|1.48|||<|0.001|TWO_SIDED|95.0|1.19|1.84||p\<0.05 indicated superiority in favor of treatment group with highest response.|Regression, Logistic|||Week 4 odds ratios, 95% Two sided CIs for Odds ratios and p-values were from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence episode reduction group, geographic region as factors and baseline value as covariate.||1.84|1.19|<0.001
72414048|NCT01458574|144337114|SUPERIORITY_OR_OTHER||Difference in percentage|44.5|||<|0.0001|TWO_SIDED|95.0|31.8|57.2|||CMH chi-square test|||At Week 24: P-value based on CMH chi-square test stratified by induction study treatment. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||57.2|31.8|<0.0001
72414049|NCT01458574|144337114|SUPERIORITY_OR_OTHER||Difference in percentage|30.0|||<|0.0001|TWO_SIDED|95.0|18.7|41.4|||CMH chi-square test|||At Week 52: P-value based on CMH chi-square test stratified by induction study treatment. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||41.4|18.7|<0.0001
72587998|NCT01908829|144706530|SUPERIORITY||Odds Ratio (OR)|1.57|||<|0.001|TWO_SIDED|95.0|1.25|1.98||p\<0.05 indicated superiority in favor of treatment group with highest response.|Regression, Logistic|||Week 8 odds ratios, 95% Two sided CIs for Odds ratios and p-values were from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence episode reduction group, geographic region as factors and baseline value as covariate.||1.98|1.25|<0.001
72587999|NCT01908829|144706530|SUPERIORITY||Odds Ratio (OR)|1.54|||=|0.001|TWO_SIDED|95.0|1.21|1.95||p\<0.05 indicated superiority in favor of treatment group with highest response.|Regression, Logistic|||Week 12 odds ratios, 95% Two sided CIs for Odds ratios and p-values were from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence episode reduction group, geographic region as factors and baseline value as covariate.||1.95|1.21|=0.001
72588000|NCT01908829|144706530|SUPERIORITY||Odds Ratio (OR)|1.51|||<|0.001|TWO_SIDED|95.0|1.2|1.9||p\<0.05 indicated superiority in favor of treatment group with highest response.|Regression, Logistic|||EoT odds ratios, 95% Two sided CIs for Odds ratios and p-values were from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence episode reduction group, geographic region as factors and baseline value as covariate.||1.90|1.20|<0.001
72588001|NCT01908829|144706531|SUPERIORITY||Odds Ratio (OR)|1.24|||=|0.119|TWO_SIDED|95.0|0.95|1.63||p\<0.05 indicated superiority in favor of treatment group with highest response.|Regression, Logistic|||Week 4 odds ratios, 95% Two sided CIs for Odds ratios and p-values were from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence episode reduction group, geographic region as factors and baseline value as covariate.||1.63|0.95|=0.119
72588002|NCT01908829|144706531|SUPERIORITY||Odds Ratio (OR)|1.56|||<|0.001|TWO_SIDED|95.0|1.23|1.98||p\<0.05 indicated superiority in favor of treatment group with highest response.|Regression, Logistic|||Week 8 odds ratios, 95% Two sided CIs for Odds ratios and p-values were from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence episode reduction group, geographic region as factors and baseline value as covariate.||1.98|1.23|<0.001
72588003|NCT01908829|144706531|SUPERIORITY||Odds Ratio (OR)|1.44|||=|0.002|TWO_SIDED|95.0|1.14|1.82||p\<0.05 indicated superiority in favor of treatment group with highest response.|Regression, Logistic|||Week 12 odds ratios, 95% Two sided CIs for Odds ratios and p-values were from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence episode reduction group, geographic region as factors and baseline value as covariate.||1.82|1.14|=0.002
72588004|NCT01908829|144706531|SUPERIORITY||Odds Ratio (OR)|1.47|||=|0.001|TWO_SIDED|95.0|1.17|1.84||p\<0.05 indicated superiority in favor of treatment group with highest response.|Regression, Logistic|||EoT odds ratios, 95% Two sided CIs for Odds ratios and p-values were from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence episode reduction group, geographic region as factors and baseline value as covariate.||1.84|1.17|=0.001
72588005|NCT01908829|144706532|SUPERIORITY||Odds Ratio (OR)|1.15|||=|0.305|TWO_SIDED|95.0|0.88|1.5||p\<0.05 indicated superiority in favor of treatment group with highest response.|Regression, Logistic|||Week 4 odds ratios, 95% Two sided CIs for Odds ratios and p-values were from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence episode reduction group, geographic region as factors and baseline value as covariate.||1.50|0.88|=0.305
72588006|NCT01908829|144706532|SUPERIORITY||Odds Ratio (OR)|1.37|||=|0.014|TWO_SIDED|95.0|1.06|1.76||p\<0.05 indicated superiority in favor of treatment group with highest response.|Regression, Logistic|||Week 8 odds ratios, 95% Two sided CIs for Odds ratios and p-values were from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence episode reduction group, geographic region as factors and baseline value as covariate.||1.76|1.06|=0.014
72588007|NCT01908829|144706532|SUPERIORITY||Odds Ratio (OR)|1.37|||=|0.012|TWO_SIDED|95.0|1.07|1.76||p\<0.05 indicated superiority in favor of treatment group with highest response.|Regression, Logistic|||Week 12 odds ratios, 95% Two sided CIs for Odds ratios and p-values were from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence episode reduction group, geographic region as factors and baseline value as covariate.||1.76|1.07|=0.012
72588008|NCT01908829|144706532|SUPERIORITY||Odds Ratio (OR)|1.29|||=|0.036|TWO_SIDED|95.0|1.02|1.64||p\<0.05 indicated superiority in favor of treatment group with highest response.|Regression, Logistic|||EoT odds ratios, 95% Two sided CIs for Odds ratios and p-values were from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence episode reduction group, geographic region as factors and baseline value as covariate.||1.64|1.02|=0.036
72588009|NCT01908829|144706533|SUPERIORITY||Odds Ratio (OR)|1.49|||=|0.001|TWO_SIDED|95.0|1.18|1.88||p\<0.05 indicated superiority in favor of treatment group with highest response.|Regression, Logistic|||Week 4 odds ratios, 95% Two sided CIs for Odds ratios and p-values were from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence episode reduction group, geographic region as factors and baseline value as covariate.||1.88|1.18|=0.001
72588010|NCT01908829|144706533|SUPERIORITY||Odds Ratio (OR)|1.69|||<|0.001|TWO_SIDED|95.0|1.31|2.18||p\<0.05 indicated superiority in favor of treatment group with highest response.|Regression, Logistic|||Week 8 odds ratios, 95% Two sided CIs for Odds ratios and p-values were from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence episode reduction group, geographic region as factors and baseline value as covariate.||2.18|1.31|<0.001
72588011|NCT01908829|144706533|SUPERIORITY||Odds Ratio (OR)|1.96|||<|0.001|TWO_SIDED|95.0|1.47|2.61||p\<0.05 indicated superiority in favor of treatment group with highest response.|Regression, Logistic|||Week 12 odds ratios, 95% Two sided CIs for Odds ratios and p-values were from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence episode reduction group, geographic region as factors and baseline value as covariate.||2.61|1.47|<0.001
72588012|NCT01908829|144706533|SUPERIORITY||Odds Ratio (OR)|1.75|||<|0.001|TWO_SIDED|95.0|1.34|2.3||p\<0.05 indicated superiority in favor of treatment group with highest response.|Regression, Logistic|||EoT odds ratios, 95% Two sided CIs for Odds ratios and p-values were from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence episode reduction group, geographic region as factors and baseline value as covariate.||2.30|1.34|<0.001
72588013|NCT01908829|144706534|SUPERIORITY||Odds Ratio (OR)|1.44|||=|0.003|TWO_SIDED|95.0|1.14|1.82||p\<0.05 indicates superiority in favor of treatment group with highest response.|Regression, Logistic|||Week 4 odds ratios, 95% Two sided CIs for Odds ratios and p-values were from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence episode reduction group, geographic region as factors and baseline value as covariate.||1.82|1.14|=0.003
72588014|NCT01908829|144706534|SUPERIORITY||Odds Ratio (OR)|1.51|||=|0.001|TWO_SIDED|95.0|1.18|1.93||p\<0.05 indicates superiority in favor of treatment group with highest response.|Regression, Logistic|||Week 8 odds ratios, 95% Two sided CIs for Odds ratios and p-values were from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence episode reduction group, geographic region as factors and baseline value as covariate.||1.93|1.18|=0.001
72588015|NCT01908829|144706534|SUPERIORITY||Odds Ratio (OR)|1.64|||<|0.001|TWO_SIDED|95.0|1.27|2.13||p\<0.05 indicates superiority in favor of treatment group with highest response.|Regression, Logistic|||Week 12 odds ratios, 95% Two sided CIs for Odds ratios and p-values were from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence episode reduction group, geographic region as factors and baseline value as covariate.||2.13|1.27|<0.001
72588016|NCT01908829|144706534|SUPERIORITY||Odds Ratio (OR)|1.5|||=|0.001|TWO_SIDED|95.0|1.17|1.91||p\<0.05 indicates superiority in favor of treatment group with highest response.|Regression, Logistic|||EoT odds ratios, 95% Two sided CIs for Odds ratios and p-values were from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence episode reduction group, geographic region as factors and baseline value as covariate.||1.91|1.17|=0.001
72588017|NCT01908829|144706535|SUPERIORITY||Odds Ratio (OR)|1.42|||=|0.003|TWO_SIDED|95.0|1.13|1.79||p\<0.05 indicated superiority in favor of treatment group with highest response.|Regression, Logistic|||Week 4 odds ratios, 95% Two sided CIs for Odds ratios and p-values were from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence episode reduction group, geographic region as factors and baseline value as covariate.||1.79|1.13|=0.003
72588018|NCT01908829|144706535|SUPERIORITY||Odds Ratio (OR)|1.44|||=|0.004|TWO_SIDED|95.0|1.12|1.84||p\<0.05 indicated superiority in favor of treatment group with highest response.|Regression, Logistic|||Week 8 odds ratios, 95% Two sided CIs for Odds ratios and p-values were from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence episode reduction group, geographic region as factors and baseline value as covariate.||1.84|1.12|=0.004
72588019|NCT01908829|144706535|SUPERIORITY||Odds Ratio (OR)|1.5|||=|0.003|TWO_SIDED|95.0|1.15|1.96||p\<0.05 indicated superiority in favor of treatment group with highest response.|Regression, Logistic|||Week 12 odds ratios, 95% Two sided CIs for Odds ratios and p-values were from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence episode reduction group, geographic region as factors and baseline value as covariate.||1.96|1.15|=0.003
72588020|NCT01908829|144706535|SUPERIORITY||Odds Ratio (OR)|1.43|||=|0.006|TWO_SIDED|95.0|1.11|1.84||p\<0.05 indicated superiority in favor of treatment group with highest response.|Regression, Logistic|||EoT odds ratios, 95% Two sided CIs for Odds ratios and p-values were from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence episode reduction group, geographic region as factors and baseline value as covariate.||1.84|1.11|=0.006
72588021|NCT01908829|144706536|SUPERIORITY||Odds Ratio (OR)|1.28|||=|0.065|TWO_SIDED|95.0|0.99|1.66|||Regression, Logistic|||Week 4 odds ratios, 95% Two sided CIs for Odds ratios and p-values were from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence episode reduction group, geographic region as factors and baseline value as covariate.||1.66|0.99|=0.065
72588022|NCT01908829|144706536|SUPERIORITY||Odds Ratio (OR)|1.41|||=|0.004|TWO_SIDED|95.0|1.11|1.79|||Regression, Logistic|||Week 8 odds ratios, 95% Two sided CIs for Odds ratios and p-values were from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence episode reduction group, geographic region as factors and baseline value as covariate.||1.79|1.11|=0.004
72588023|NCT01908829|144706536|SUPERIORITY||Odds Ratio (OR)|1.64|||<|0.001|TWO_SIDED|95.0|1.3|2.07|||Regression, Logistic|||Week 12 odds ratios, 95% Two sided CIs for Odds ratios and p-values were from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence episode reduction group, geographic region as factors and baseline value as covariate.||2.07|1.30|<0.001
72588024|NCT01908829|144706536|SUPERIORITY||Odds Ratio (OR)|1.55|||<|0.001|TWO_SIDED|95.0|1.24|1.94|||Regression, Logistic|||EoT odds ratios, 95% Two sided CIs for Odds ratios and p-values were from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence episode reduction group, geographic region as factors and baseline value as covariate.||1.94|1.24|<0.001
72588025|NCT01339923|144706586|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority.|Vaccine group difference|-1.0|||||TWO_SIDED|95.0|-6.4|3.9|||Miettinen and Nurminen method|||Non-inferiority of MenC-CRM was determined following co-administration of MenC-CRM and rMenB+OMV NZ vs MenC-CRM control group at 1 month after 2nd vaccination for serogroup C.||3.9|-6.4|
72588026|NCT01339923|144706586|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority.|Vaccine group difference|0.0|||||TWO_SIDED|95.0|-5.2|7.6|||Miettinen and Nurminen method|||Non-inferiority of MenC-CRM was determined following co-administration of MenC-CRM and rMenB+OMV NZ vs MenC-CRM control group at 1 month after booster vaccination for serogroup C.||7.6|-5.2|
72588027|NCT03660189|144706616|SUPERIORITY|||||||0.54|||||||t-test, 2 sided|||||||0.54
72588028|NCT03660189|144706616|SUPERIORITY|||||||0.44|||||||t-test, 2 sided|||||||0.44
72588029|NCT03660189|144706618|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.0
72588030|NCT03660189|144706621|SUPERIORITY|||||||0.91|||||||Fisher Exact|||||||0.91
72588031|NCT03660189|144706622|SUPERIORITY|||||||0.45|||||||Fisher Exact|||||||0.45
72588032|NCT03660189|144706626|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.0
72588033|NCT03660189|144706627|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.0
72588034|NCT00403481|144706635|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||No multiplicity adjustments|One-sample t-test|||||||<0.0001
72588035|NCT00403481|144706636|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||\<0.0001 for both daytime and nighttime. No multiplicity adjustments.|one-sample t-test|||||||<0.0001
72588036|NCT00403481|144706637|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||One-sample t-test|||||||<0.0001
72588037|NCT00403481|144706638|SUPERIORITY_OR_OTHER|||||||0.0001||95.0||||No multiplicity adjustments|one-sample t-test|||||||0.0001
72588038|NCT00403481|144706640|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||one-sample t-test|||||||<0.0001
72588039|NCT00403481|144706641|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||\<0.0001 applies to both the daytime and nighttime analyses|one-sample t-test|||||||<0.0001
72588040|NCT00403481|144706642|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||one-sample t-test|||||||<0.0001
72588041|NCT00403481|144706643|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||\<0.0001 applies to both 4 hour and 6 hour analyses|one-sample t-test|||||||<0.0001
72414050|NCT01458574|144337114|SUPERIORITY_OR_OTHER||Difference in percentage|43.2|||<|0.0001|TWO_SIDED|95.0|31.1|55.3|||CMH chi-square test|||At Week 52: P-value based on CMH chi-square test stratified by induction study treatment. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||55.3|31.1|<0.0001
72414051|NCT01458574|144337115|SUPERIORITY_OR_OTHER||Difference in percentage|24.4|||<|0.0001|TWO_SIDED|95.0|13.8|35.0|||CMH chi-square test|||P-value based on CMH chi-square test stratified by induction study treatment. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||35.0|13.8|<0.0001
72414052|NCT01458574|144337115|SUPERIORITY_OR_OTHER||Difference in percentage|40.5|||<|0.0001|TWO_SIDED|95.0|28.7|52.3|||CMH chi-square test|||P-value based on CMH chi-square test stratified by induction study treatment. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||52.3|28.7|<0.0001
72588042|NCT02099110|144706665|SUPERIORITY_OR_OTHER||Difference in the least squares means|-0.46|||<|0.001|TWO_SIDED|95.0|-0.63|-0.3||Constrained longitudinal data analysis (cLDA) model with fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.|Constrained longitudinal data analysis|||||-0.30|-0.63|<0.001
72414053|NCT01458574|144337116|SUPERIORITY_OR_OTHER||Difference in percentage|30.3|||<|0.0001|TWO_SIDED|95.0|20.9|39.7|||CMH chi-square test|||At Week 24: P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||39.7|20.9|<0.0001
72588043|NCT02099110|144706665|SUPERIORITY_OR_OTHER||Difference in the least squares means|-0.43|||<|0.001|TWO_SIDED|95.0|-0.6|-0.27||cLDA model with fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.|Constrained longitudinal data analysis|||||-0.27|-0.60|<0.001
72588044|NCT02099110|144706665|SUPERIORITY_OR_OTHER||Difference in the least squares means|-0.44|||<|0.001|TWO_SIDED|95.0|-0.61|-0.27||cLDA model with fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.|Constrained longitudinal data analysis|||||-0.27|-0.61|<0.001
72588045|NCT02099110|144706665|SUPERIORITY_OR_OTHER||Difference in the least squares means|-0.47|||<|0.001|TWO_SIDED|95.0|-0.63|-0.3||cLDA model with fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.|Constrained longitudinal data analysis|||||-0.30|-0.63|<0.001
72588046|NCT02099110|144706666|SUPERIORITY_OR_OTHER||Difference in % vs Ertugliflozin 5 mg|-3.2|||||TWO_SIDED|95.0|-11.7|5.5|||||Based on Miettinen \& Nurminen method.|||5.5|-11.7|
72588047|NCT02099110|144706666|SUPERIORITY_OR_OTHER||Difference in % vs. Ertugliflozin 15 mg|-1.9|||||TWO_SIDED|95.0|-10.6|6.8|||||Based on Miettinen \& Nurminen method.|||6.8|-10.6|
72588048|NCT02099110|144706666|SUPERIORITY_OR_OTHER||Difference in % vs. Sitagliptin 100 mg|1.4|||||TWO_SIDED|95.0|-7.4|10.1|||||Based on Miettinen \& Nurminen method.|||10.1|-7.4|
72588049|NCT02099110|144706666|SUPERIORITY_OR_OTHER||Difference in % vs. Sitagliptin 100 mg|-1.8|||||TWO_SIDED|95.0|-10.5|7.0|||||Based on Miettinen \& Nurminen method.|||7.0|-10.5|
72588050|NCT02099110|144706667|SUPERIORITY_OR_OTHER||Difference in % vs. Ertugliflozin 5 mg|0.1|||||TWO_SIDED|95.0|-3.3|3.6|||||Based on Miettinen \& Nurminen method.|||3.6|-3.3|
72588051|NCT02099110|144706667|SUPERIORITY_OR_OTHER||Difference in % vs. Ertugliflozin 15 mg|0.5|||||TWO_SIDED|95.0|-3.0|4.0|||||Based on Miettinen \& Nurminen method.|||4.0|-3.0|
72588052|NCT02099110|144706667|SUPERIORITY_OR_OTHER||Difference in % vs. Sitagliptin 100 mg|0.5|||||TWO_SIDED|95.0|-2.9|3.9|||||Based on Miettinen \& Nurminen method.|||3.9|-2.9|
72588053|NCT02099110|144706667|SUPERIORITY_OR_OTHER||Difference in % vs. Sitagliptin 100 mg|0.9|||||TWO_SIDED|95.0|-2.5|4.4|||||Based on Miettinen \& Nurminen method.|||4.4|-2.5|
72588054|NCT02099110|144706668|SUPERIORITY_OR_OTHER||Difference in the least squares means|-1.85|||<|0.001|TWO_SIDED|95.0|-2.48|-1.22||cLDA model including fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.|Constrained longitudinal data analysis|||||-1.22|-2.48|<0.001
72588055|NCT02099110|144706668|SUPERIORITY_OR_OTHER||Difference in the least squares means|-2.27|||<|0.001|TWO_SIDED|95.0|-2.9|-1.64||cLDA model including fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.|Constrained logitudinal data analysis|||||-1.64|-2.90|<0.001
72588056|NCT02099110|144706669|SUPERIORITY_OR_OTHER||Difference in the least squares means|-8.23||||0.004|TWO_SIDED|95.0|-13.82|-2.65||cLDA model including fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.|cLDA|||||-2.65|-13.82|0.004
72588057|NCT02099110|144706669|SUPERIORITY_OR_OTHER||Difference in the least squares means|-11.79|||<|0.001|TWO_SIDED|95.0|-17.35|-6.23||cLDA model including fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.|cLDA|||||-6.23|-17.35|<0.001
72588058|NCT02099110|144706669|SUPERIORITY_OR_OTHER||Difference in the least squares means|-18.4|||<|0.001|TWO_SIDED|95.0|-24.03|-12.77||cLDA model including fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.|cLDA|||||-12.77|-24.03|<0.001
72588059|NCT02099110|144706669|SUPERIORITY_OR_OTHER||Difference in the least squares means|-23.14|||<|0.001|TWO_SIDED|95.0|-28.76|-17.53||cLDA model including fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.|cLDA|||||-17.53|-28.76|<0.001
72588060|NCT02099110|144706670|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.14|||<|0.001|TWO_SIDED|95.0|2.68|6.4||Adjusted Odds Ratio using a logistic regression model fitted with fixed effects for treatment, covariates for baseline A1C and baseline eGFR.|Regression, Logistic|||||6.40|2.68|<0.001
72588061|NCT02099110|144706670|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.53|||<|0.001|TWO_SIDED|95.0|1.68|3.83||Adjusted Odds Ratio using a logistic regression model fitted with fixed effects for treatment, covariates for baseline A1C and baseline eGFR.|Regression, Logistic|||||3.83|1.68|<0.001
72588062|NCT02099110|144706670|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.95|||<|0.001|TWO_SIDED|95.0|1.92|4.54||Adjusted Odds Ratio using a logistic regression model fitted with fixed effects for treatment, covariates for baseline A1C and baseline eGFR.|Regression, Logistic|||||4.54|1.92|<0.001
72588063|NCT02099110|144706670|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.56|||<|0.001|TWO_SIDED|95.0|1.69|3.89|||Regression, Logistic|Adjusted Odds Ratio using a logistic regression model fitted with fixed effects for treatment, covariates for baseline A1C and baseline eGFR.||||3.89|1.69|<0.001
72588064|NCT02099110|144706671|SUPERIORITY_OR_OTHER||Difference in the least squares means|7.61||||0.155|TWO_SIDED|95.0|-2.9|18.13||cLDA model with fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.|Constrained longitudinal data analysis|||||18.13|-2.90|0.155
72588065|NCT02099110|144706671|SUPERIORITY_OR_OTHER||Difference in the least squares means|-4.87||||0.369|TWO_SIDED|95.0|-15.54|5.8||cLDA model with fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.|Constrained longitudinal data analysis|||||5.80|-15.54|0.369
72588066|NCT02099110|144706671|SUPERIORITY_OR_OTHER||Difference in the least squares means|1.81||||0.734|TWO_SIDED|95.0|-8.66|12.27||cLDA model with fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.|Constrained longitudinal data analysis|||||12.27|-8.66|0.734
72588067|NCT02099110|144706671|SUPERIORITY_OR_OTHER||Difference in the least squares means|-9.59||||0.075|TWO_SIDED|95.0|-20.17|0.98||cLDA model with fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.|Difference in the least squares means|||||0.98|-20.17|0.075
72588068|NCT02099110|144706672|SUPERIORITY_OR_OTHER||Difference in the least squares means|-2.76||||0.005|TWO_SIDED|95.0|-4.69|-0.83||cLDA model with fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.|Constrained longitudinal data analysis|||||-0.83|-4.69|0.005
72588069|NCT02099110|144706672|SUPERIORITY_OR_OTHER||Difference in the least squares means|-3.01||||0.002|TWO_SIDED|95.0|-4.94|-1.09||cLDA model with fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.|Constrained longitudinal data analysis|||||-1.09|-4.94|0.002
72588070|NCT00994461|144706682|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED|||||Cochran-Mantel-Haenszel (CMH) test stratified by H. pylori status was employed for the comparison of celecoxib and loxoprofen with placebo. The multiplicity of test was not adjusted because these comparisons were for the secondary objective.|Cochran-Mantel-Haenszel|CMH test stratified by H. pylori status was employed. Continuous correction was used.||Hypothesis testing was conducted with significant p-value level of under 0.05.||||<0.0001
72588071|NCT03139578|144706689|NON_INFERIORITY|Non-inferiority margin of 0.625 was used. If the lower limit of 95% confidence interval was greater than a non-inferiority margin of 0.625, then non-inferiority of Test relative to Control was concluded.|Cumulative Odds Ratio|1.18|||||TWO_SIDED|95.0|0.46|3.06|||Generalized linear mixed model|Simulation-based adjustment was utilized to address the multiple comparisons of different base curves.|Cumulative odds ratio was calculated as Test over Control.|||3.06|0.46|
72588072|NCT03139578|144706689|NON_INFERIORITY|Non-inferiority margin of 0.625 was used. If the lower limit of 95% confidence interval was greater than a non-inferiority margin of 0.625, then non-inferiority of Test relative to Control was concluded.|Cumulative Odds Ratio|0.93|||||TWO_SIDED|95.0|0.34|2.52|||Generalized linear mixed model|Simulation-based adjustment was utilized to address the multiple comparisons of different base curves.|Cumulative odds ratio was calculated as Test over Control.|||2.52|0.34|
72588073|NCT03139578|144706690|EQUIVALENCE|Equivalence margin of 70% was used for no difference in lens power requirement.|Proportion (%)|93.8|||||TWO_SIDED|97.5|81.1|98.1|||Wilson Method||Lens power requirement difference was calculated as Test minus Control. Then the proportion of eyes with similar lens power requirements (no difference or difference within ±0.25D) was calculated.|||98.1|81.1|
72588074|NCT03139578|144706690|EQUIVALENCE|Equivalence margin of 70% was used for no difference in lens power requirement.|Proportion (%)|83.3|||||TWO_SIDED|97.5|68.3|92.1|||Wilson Method||Lens power requirement difference was calculated as Test minus Control. Then the proportion of eyes with similar lens power requirements (no difference or difference within ±0.25D) was calculated.|||92.1|68.3|
72588075|NCT03139578|144706690|EQUIVALENCE|Equivalence margin of 80% was used for the lens power requirement difference within ±0.25 D.|Proportion (%)|100.0|||||TWO_SIDED|97.5|90.5|100.0|||Wilson Method||Lens power requirement difference was calculated as Test minus Control. Then the proportion of eyes with similar lens power requirements (no difference or difference within ±0.25D) was calculated.|||100|90.5|
72588076|NCT03139578|144706690|EQUIVALENCE|Equivalence margin of 80% was used for the lens power requirement difference within ±0.25 D.|Proportion (%)|100.0|||||TWO_SIDED|97.5|90.5|100.0|||Wilson Method||Lens power requirement difference was calculated as Test minus Control. Then the proportion of eyes with similar lens power requirements (no difference or difference within ±0.25D) was calculated.|||100.0|90.5|
72588077|NCT03139578|144706691|NON_INFERIORITY|Non-inferiority margin of -1 was used. If the lower limit of 95% confidence interval was greater than a non-inferiority margin of -1, then non-inferiority of Test relative to Control was concluded.|Least square mean difference|0.2|||||TWO_SIDED|95.0|-0.3|0.7|||Linear mixed model|Simulation-based adjustment was used to address the multiple comparisons.||||0.7|-0.3|
72588078|NCT03139578|144706691|NON_INFERIORITY|Non-inferiority margin of -1 was used. If the lower limit of 95% confidence interval was greater than a non-inferiority margin of -1, then non-inferiority of Test relative to Control was concluded.|Least square mean difference|0.0|||||TWO_SIDED|95.0|-0.5|0.5|||Linear mixed model|Simulation-based adjustment was used to address the multiple comparisons.||||0.5|-0.5|
72588079|NCT03139578|144706692|NON_INFERIORITY|Non-inferiority margin of -1 was used. If the lower limit of 95% confidence interval was greater than a non-inferiority margin of -1, then non-inferiority of Test relative to Control was concluded.|Least square mean difference|-0.1|||||TWO_SIDED|95.0|-0.4|0.3|||Linear mixed model|Simulation-based adjustment was used to address the multiple comparisons.||||0.3|-0.4|
72588080|NCT03139578|144706692|NON_INFERIORITY|Non-inferiority margin of -1 was used. If the lower limit of 95% confidence interval was greater than a non-inferiority margin of -1, then non-inferiority of Test relative to Control was concluded.|Least square mean difference|0.1|||||TWO_SIDED|95.0|-0.2|0.5|||Linear mixed model|Simulation-based adjustment was used to address the multiple comparisons.||||0.5|-0.2|
72588081|NCT03139578|144706693|NON_INFERIORITY|Non-inferiority margin of -1 was used. If the lower limit of 95% confidence interval was greater than a non-inferiority margin of -1, then non-inferiority of Test relative to Control was concluded.|Least square mean difference|0.1|||||TWO_SIDED|95.0|-0.1|0.4|||Linear mixed model|Simulation-based adjustment was used to address the multiple comparisons.||||0.4|-0.1|
72588082|NCT03139578|144706693|NON_INFERIORITY|Non-inferiority margin of -1 was used. If the lower limit of 95% confidence interval was greater than a non-inferiority margin of -1, then non-inferiority of Test relative to Control was concluded.|Least square mean difference|0.1|||||TWO_SIDED|95.0|-0.2|0.3|||Linear mixed model|Simulation-based adjustment was used to address the multiple comparisons.||||0.3|-0.2|
72588083|NCT03139578|144706694|NON_INFERIORITY|Non-inferiority margin of -1 was used. If the lower limit of 95% confidence interval was greater than a non-inferiority margin of -1, then non-inferiority of Test relative to Control was concluded.|Least square mean difference|0.0|||||TWO_SIDED|95.0|-0.5|0.5|||Linear mixed model|Simulation-based adjustment was used to address the multiple comparisons.||||0.5|-0.5|
72588084|NCT03139578|144706694|NON_INFERIORITY|Non-inferiority margin of -1 was used. If the lower limit of 95% confidence interval was greater than a non-inferiority margin of -1, then non-inferiority of Test relative to Control was concluded.|Least square mean difference|-0.1|||||TWO_SIDED|95.0|-0.6|0.4|||Linear mixed model|Simulation-based adjustment was used to address the multiple comparisons.||||0.4|-0.6|
72588085|NCT03139578|144706695|NON_INFERIORITY|Non-inferiority margin of 0.1 was used. If the upper limit of 95% confidence interval was lower than a non-inferiority margin of 0.1, then non-inferiority of Test relative to Control was concluded.|Least square mean difference|0.002|||||TWO_SIDED|95.0|-0.009|0.012|||Linear mixed model|Simulation-based adjustment was used to address the multiple comparisons.||||0.012|-0.009|
72588086|NCT03139578|144706695|NON_INFERIORITY|Non-inferiority margin of 0.1 was used. If the upper limit of 95% confidence interval was lower than a non-inferiority margin of 0.1, then non-inferiority of Test relative to Control was concluded.|Least square mean difference|-0.001|||||TWO_SIDED|95.0|-0.012|0.009|||Linear mixed model|Simulation-based adjustment was used to address the multiple comparisons.||||0.009|-0.012|
72588087|NCT03793842|144706696|EQUIVALENCE|Equivalence margin 1 J/min||||||0.002|||||||t-test, 2 sided|||||||.002
72588088|NCT03793842|144706697|SUPERIORITY|||||||0.2|||||||t-test, 2 sided|||||||0.2
72588089|NCT03793842|144706698|EQUIVALENCE|Equivalence margin 1 cm H20|Mean Difference (Net)|0.05||||0.006|TWO_SIDED||||||t-test, 2 sided|||||||0.006
72588090|NCT03793842|144706699|SUPERIORITY|||||||0.003|||||||t-test, 2 sided|||||||0.003
72588091|NCT03793842|144706700|SUPERIORITY|||||||0.008|||||||t-test, 2 sided|||||||0.008
72588092|NCT02115581|144706720|SUPERIORITY_OR_OTHER|||||||0.267||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.267
72588093|NCT02115581|144706721|SUPERIORITY_OR_OTHER|||||||0.011|||||||Fisher Exact|||||||0.011
72588094|NCT01377922|144706722|OTHER|Estimated via a MMRM with change from baseline (Day 1, Part 2), Day 8, and Day 14 as the dependent variable and terms for treatment, time (Day 8, Day 14), treatment-by-time interaction, and double-blind baseline QMG score as fixed effects and patient as a random effect. The model assumed time effect to be random between patients.||||||0.0452|||||||Mixed Models Analysis|Pairwise contrast at Day 14 from MMRM model.||||||0.0452
72588095|NCT01377922|144706723|OTHER|||||||0.0028||||||Pairwise contrast at Day 14 from MMRM model.|Mixed Models Analysis|||Estimated via a MMRM with change from baseline (Day 1, Part 2), Day 8, and Day 14 as the dependent variable and terms for treatment, time (Day 8, Day 14), treatment-by-time interaction, and double-blind baseline SGI score as fixed effects and patient as a random effect. The model assumed time effect to be random between patients||||0.0028
72588096|NCT01377922|144706724|OTHER|||||||0.6274|||||||Mixed Models Analysis|||Estimated via a MMRM with change from baseline (Day 1, Part 2), Day 8, and Day 14 as the dependent variable and terms for treatment, time (Day 8, Day 14), treatment-by-time interaction, and double-blind baseline T25FW walking speed as fixed effects and patient as a random effect. The model assumed time effect to be random between patients.||||0.6274
72588097|NCT01377922|144706725|OTHER|||||||0.0267|||||||Mixed Models Analysis|||Estimated via a MMRM with change from baseline (Day 1, Part 2), Day 8, and Day 14 as the dependent variable and terms for treatment, time (Day 8, Day 14), treatment-by-time interaction as fixed effects and patient as a random effect. The model assumed time effect to be random between patients||||0.0267
72588098|NCT00468481|144706886|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|384.7|||<|0.0001||95.0|282.42|486.98|||ANCOVA|Analysis of Covariance (ANCOVA) with treatment as factor and Baseline (RBC folate) as covariate|Difference = DRSP/EE/MTHF - YAZ|The null hypothesis was that the difference between DRSP/EE/MTHF and Yaz treatment groups in the RBC folate levels at week 24 was 0.||486.98|282.42|<0.0001
72588099|NCT00468481|144706887|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|18.87|||<|0.0001||95.0|14.04|23.7|||ANCOVA|Analysis of Covariance (ANCOVA) with treatment as factor and Baseline (plasma folate) as covariate|Difference =DRSP/EE/MTHF - YAZ|The null hypothesis was that the difference between DRSP/EE/MTHF and Yaz treatment groups in the plasma folate levels at week 24 was 0.||23.70|14.04|<0.0001
72588100|NCT00734162|144706933|SUPERIORITY_OR_OTHER||||||<|0.001||||||A p-value of \< 0.05 was considered statistically significant.|Cochran-Mantel-Haenszel|||Analysis is the difference between treatment groups in the proportion of participants who met the outcome measure criterion, controlling for randomization age group.||||< 0.001
72588101|NCT01515865|144706999|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-13.8||||0.3145|TWO_SIDED|95.0|-37.6|9.8|||Fisher Exact|||||9.8|-37.6|0.3145
72588102|NCT04606394|144707013|SUPERIORITY||Mean Difference (Final Values)|1.0||||0.33|TWO_SIDED||||||Chi-squared|||Data outcome reported was the number and percentage of subject test days with DPI Failure in subjects in suboptimal PIF (\<60 L/min) versus normal PIF subjects. Statistical analysis performed was a comparison between rates of DPI Failure in the 2 groups.||||0.33
72588103|NCT04606394|144707014|SUPERIORITY||Mean Difference (Final Values)|1.0||||0.04|TWO_SIDED||||||Chi-squared|||Data outcome reported was the number and percentage of subject test days with DPI Failure in subjects in suboptimal PIF (\<60 L/min) versus normal PIF subjects. Statistical analysis performed was a comparison between rates of DPI Failure in the 2 groups.||||0.04
72588104|NCT03423173|144707016|EQUIVALENCE|Equivalence between immune responses of 2 trial groups was established if the 95% CI of the corresponding geometric mean ratio was within pre-specified equivalence margins of 0.5 and 2.0.|Geometric Mean Titer (GMT) Ratio|0.69|||||TWO_SIDED|95.0|0.46|1.04|||||Analysis of variance (ANOVA) model was used for analysis, including natural logarithms of titers as a response variable and trial group as a factor.|DENV-1||1.04|0.46|
72588105|NCT03423173|144707016|EQUIVALENCE|Equivalence between immune responses of 2 trial groups was established if the 95% CI of the corresponding geometric mean ratio was within pre-specified equivalence margins of 0.5 and 2.0.|GMT Ratio|0.91|||||TWO_SIDED|95.0|0.6|1.38|||||ANOVA model was used for analysis, including natural logarithms of titers as a response variable and trial group as a factor.|DENV-1||1.38|0.60|
72588106|NCT03423173|144707016|EQUIVALENCE|Equivalence between immune responses of 2 trial groups was established if the 95% CI of the corresponding geometric mean ratio was within pre-specified equivalence margins of 0.5 and 2.0.|GMT Ratio|0.63|||||TWO_SIDED|95.0|0.41|0.96|||||ANOVA model was used for analysis, including natural logarithms of titers as a response variable and trial group as a factor.|DENV-1||0.96|0.41|
72588107|NCT03423173|144707016|EQUIVALENCE|Equivalence between immune responses of 2 trial groups was established if the 95% CI of the corresponding geometric mean ratio was within pre-specified equivalence margins of 0.5 and 2.0.|GMT Ratio|1.3|||||TWO_SIDED|95.0|0.98|1.71|||||ANOVA model was used for analysis, including natural logarithms of titers as a response variable and trial group as a factor.|DENV-2||1.71|0.98|
72588108|NCT03423173|144707016|EQUIVALENCE|Equivalence between immune responses of 2 trial groups was established if the 95% CI of the corresponding geometric mean ratio was within pre-specified equivalence margins of 0.5 and 2.0.|GMT Ratio|0.67|||||TWO_SIDED|95.0|0.51|0.88|||||ANOVA model was used for analysis, including natural logarithms of titers as a response variable and trial group as a factor.|DENV-2||0.88|0.51|
72588109|NCT03423173|144707016|EQUIVALENCE|Equivalence between immune responses of 2 trial groups was established if the 95% CI of the corresponding geometric mean ratio was within pre-specified equivalence margins of 0.5 and 2.0.|GMT Ratio|0.86|||||TWO_SIDED|95.0|0.65|1.15|||||ANOVA model was used for analysis, including natural logarithms of titers as a response variable and trial group as a factor.|DENV-2||1.15|0.65|
72588110|NCT03423173|144707016|EQUIVALENCE|Equivalence between immune responses of 2 trial groups was established if the 95% CI of the corresponding geometric mean ratio was within pre-specified equivalence margins of 0.5 and 2.0.|GMT Ratio|1.27|||||TWO_SIDED|95.0|0.91|1.78|||||ANOVA model was used for analysis, including natural logarithms of titers as a response variable and trial group as a factor.|DENV-3||1.78|0.91|
72588111|NCT03423173|144707016|EQUIVALENCE|Equivalence between immune responses of 2 trial groups was established if the 95% CI of the corresponding geometric mean ratio was within pre-specified equivalence margins of 0.5 and 2.0.|GMT Ratio|0.95|||||TWO_SIDED|95.0|0.68|1.33|||||ANOVA model was used for analysis, including natural logarithms of titers as a response variable and trial group as a factor.|DENV-3||1.33|0.68|
72414054|NCT01458574|144337116|SUPERIORITY_OR_OTHER||Difference in percentage|37.2|||<|0.0001|TWO_SIDED|95.0|28.1|46.4|||CMH chi-square test|||At Week 24: P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||46.4|28.1|<0.0001
72414055|NCT01458574|144337116|SUPERIORITY_OR_OTHER||Difference in percentage|31.3|||<|0.0001|TWO_SIDED|95.0|22.4|40.2|||CMH chi-square test|||At Week 52: P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||40.2|22.4|<0.0001
72414056|NCT01458574|144337116|SUPERIORITY_OR_OTHER||Difference in percentage|41.7|||<|0.0001|TWO_SIDED|95.0|32.9|50.5|||CMH chi-square test|||At Week 52: P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||50.5|32.9|<0.0001
72588112|NCT03423173|144707016|EQUIVALENCE|Equivalence between immune responses of 2 trial groups was established if the 95% CI of the corresponding geometric mean ratio was within pre-specified equivalence margins of 0.5 and 2.0.|GMT Ratio|1.22|||||TWO_SIDED|95.0|0.87|1.71|||||ANOVA model was used for analysis, including natural logarithms of titers as a response variable and trial group as a factor.|DENV-3||1.71|0.87|
72588113|NCT03423173|144707016|EQUIVALENCE|Equivalence between immune responses of 2 trial groups was established if the 95% CI of the corresponding geometric mean ratio was within pre-specified equivalence margins of 0.5 and 2.0.|GMT Ratio|0.62|||||TWO_SIDED|95.0|0.46|0.82|||||ANOVA model was used for analysis, including natural logarithms of titers as a response variable and trial group as a factor.|DENV-4||0.82|0.46|
72588114|NCT03423173|144707016|EQUIVALENCE|Equivalence between immune responses of 2 trial groups was established if the 95% CI of the corresponding geometric mean ratio was within pre-specified equivalence margins of 0.5 and 2.0.|GMT Ratio|1.62|||||TWO_SIDED|95.0|1.22|2.17|||||ANOVA model was used for analysis, including natural logarithms of titers as a response variable and trial group as a factor.|DENV-4||2.17|1.22|
72588115|NCT03423173|144707016|EQUIVALENCE|Equivalence between immune responses of 2 trial groups was established if the 95% CI of the corresponding geometric mean ratio was within pre-specified equivalence margins of 0.5 and 2.0.|GMT Ratio|1.0|||||TWO_SIDED|95.0|0.75|1.35|||||ANOVA model was used for analysis, including natural logarithms of titers as a response variable and trial group as a factor.|DENV-4||1.35|0.75|
72588116|NCT03423173|144707017|OTHER||Seropositivity Rates Difference|0.6|||||TWO_SIDED|95.0|-4.99|6.06|||||95% CI for the differences in seropositivity rates between TDV lots were calculated using the Newcombe and Wilson method.|DENV-1 at Day 120||6.06|-4.99|
72588117|NCT03423173|144707017|OTHER||Seropositivity Rate Difference|-1.65|||||TWO_SIDED|95.0|-6.9|3.19|||||95% CI for the differences in seropositivity rates between TDV lots were calculated using the Newcombe and Wilson method.|DENV-1 at Day 120||3.19|-6.90|
72588118|NCT03423173|144707017|OTHER||Seropositivity Rate Difference|-2.25|||||TWO_SIDED|95.0|-7.45|2.69|||||95% CI for the differences in seropositivity rates between TDV lots were calculated using the Newcombe and Wilson method.|DENV-1 at Day 120||2.69|-7.45|
72588119|NCT03423173|144707017|OTHER||Seropositivity Rate Difference|7.87|||||TWO_SIDED|95.0|0.64|15.3|||||95% CI for the differences in seropositivity rates between TDV lots were calculated using the Newcombe and Wilson method.|DENV-1 at Day 270||15.30|0.64|
72588120|NCT03423173|144707017|OTHER||Seropositivity Rate Difference|1.5|||||TWO_SIDED|95.0|-4.67|7.65|||||95% CI for the differences in seropositivity rates between TDV lots were calculated using the Newcombe and Wilson method.|DENV-1 at Day 270||7.65|-4.67|
72588121|NCT03423173|144707017|OTHER||Seropositivity Rate Difference|-6.37|||||TWO_SIDED|95.0|-14.0|1.04|||||95% CI for the differences in seropositivity rates between TDV lots were calculated using the Newcombe and Wilson method.|DENV-1 at Day 270||1.04|-14.00|
72588122|NCT03423173|144707017|OTHER||Seropositivity Rate Difference|0.72|||||TWO_SIDED|95.0|-3.87|5.29|||||95% CI for the differences in seropositivity rates between TDV lots were calculated using the Newcombe and Wilson method.|DENV-2 at Day 120||5.29|-3.87|
72588123|NCT03423173|144707017|OTHER||Seropositivity Rate Difference|-0.83|||||TWO_SIDED|95.0|-5.24|3.17|||||95% CI for the differences in seropositivity rates between TDV lots were calculated using the Newcombe and Wilson method.|DENV-2 at Day 120||3.17|-5.24|
72588124|NCT03423173|144707017|OTHER||Seropositivity Rate Difference|-1.55|||||TWO_SIDED|95.0|-6.05|2.58|||||95% CI for the differences in seropositivity rates between TDV lots were calculated using the Newcombe and Wilson method.|DENV-2 at Day 120||2.58|-6.05|
72588125|NCT03423173|144707017|OTHER||Seropositivity Rate Difference|2.42|||||TWO_SIDED|95.0|-2.12|7.44|||||95% CI for the differences in seropositivity rates between TDV lots were calculated using the Newcombe and Wilson method.|DENV-2 at Day 270||7.44|-2.12|
72588126|NCT03423173|144707017|OTHER||Seropositivity Rate Difference|0.83|||||TWO_SIDED|95.0|-3.41|5.24|||||95% CI for the differences in seropositivity rates between TDV lots were calculated using the Newcombe and Wilson method.|DENV-2 at Day 270||5.24|-3.41|
72588127|NCT03423173|144707017|OTHER||Seropositivity Rate Difference|-1.59|||||TWO_SIDED|95.0|-6.67|3.17|||||95% CI for the differences in seropositivity rates between TDV lots were calculated using the Newcombe and Wilson method.|DENV-2 at Day 270||3.17|-6.67|
72588128|NCT03423173|144707017|OTHER||Seropositivity Rate Difference|2.93|||||TWO_SIDED|95.0|-3.07|9.06|||||95% CI for the differences in seropositivity rates between TDV lots were calculated using the Newcombe and Wilson method.|DENV-3 at Day 120||9.06|-3.07|
72588129|NCT03423173|144707017|OTHER||Seropositivity Rate Difference|-0.81|||||TWO_SIDED|95.0|-6.17|4.44|||||95% CI for the differences in seropositivity rates between TDV lots were calculated using the Newcombe and Wilson method.|DENV-3 at Day 120||4.44|-6.17|
72414057|NCT01458574|144337117|SUPERIORITY_OR_OTHER||Difference in percentage|29.8|||<|0.0001|TWO_SIDED|95.0|20.9|38.7|||CMH chi-square test|||P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||38.7|20.9|<0.0001
72588130|NCT03423173|144707017|OTHER||Seropositivity Rate Difference|-3.73|||||TWO_SIDED|95.0|-9.74|2.03|||||95% CI for the differences in seropositivity rates between TDV lots were calculated using the Newcombe and Wilson method.|DENV-3 at Day 120||2.03|-9.74|
72588131|NCT03423173|144707017|OTHER||Seropositivity Rate Difference|6.79|||||TWO_SIDED|95.0|-1.03|14.56|||||95% CI for the differences in seropositivity rates between TDV lots were calculated using the Newcombe and Wilson method.|DENV-3 at Day 270||14.56|-1.03|
72588132|NCT03423173|144707017|OTHER||Seropositivity Rate Difference|3.0|||||TWO_SIDED|95.0|-4.28|10.23|||||95% CI for the differences in seropositivity rates between TDV lots were calculated using the Newcombe and Wilson method.|DENV-3 at Day 270||10.23|-4.28|
72588133|NCT03423173|144707017|OTHER||Seropositivity Rate Difference|-3.79|||||TWO_SIDED|95.0|-11.97|4.39|||||95% CI for the differences in seropositivity rates between TDV lots were calculated using the Newcombe and Wilson method.|DENV-3 at Day 270||4.39|-11.97|
72588134|NCT03423173|144707017|OTHER||Seropositivity Rate Difference|-2.5|||||TWO_SIDED|95.0|-7.68|1.55|||||95% CI for the differences in seropositivity rates between TDV lots were calculated using the Newcombe and Wilson method.|DENV-4 at Day 120||1.55|-7.68|
72588135|NCT03423173|144707017|OTHER||Seropositivity Rate Difference|0.04|||||TWO_SIDED|95.0|-5.47|5.62|||||95% CI for the differences in seropositivity rates between TDV lots were calculated using the Newcombe and Wilson method.|DENV-4 at Day 120||5.62|-5.47|
72588136|NCT03423173|144707017|OTHER||Seropositivity Rate Difference|2.54|||||TWO_SIDED|95.0|-1.52|7.81|||||95% CI for the differences in seropositivity rates between TDV lots were calculated using the Newcombe and Wilson method.|DENV-4 at Day 120||7.81|-1.52|
72588137|NCT03423173|144707017|OTHER||Seropositivity Rate Difference|-1.52|||||TWO_SIDED|95.0|-9.14|5.69|||||95% CI for the differences in seropositivity rates between TDV lots were calculated using the Newcombe and Wilson method.|DENV-4 at Day 270||5.69|-9.14|
72414058|NCT01458574|144337117|SUPERIORITY_OR_OTHER||Difference in percentage|40.2|||<|0.0001|TWO_SIDED|95.0|31.4|49.0|||CMH chi-square test|||P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||49.0|31.4|<0.0001
72414059|NCT01458574|144337118|SUPERIORITY_OR_OTHER||Difference in percentage|23.2|||<|0.0001|TWO_SIDED|95.0|15.3|31.2|||CMH chi-square test|||At Week 24: P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||31.2|15.3|<0.0001
72414060|NCT01458574|144337118|SUPERIORITY_OR_OTHER||Difference in percentage|24.4|||<|0.0001|TWO_SIDED|95.0|16.4|32.4|||CMH chi-square test|||At Week 24: P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||32.4|16.4|<0.0001
72414061|NCT01458574|144337118|SUPERIORITY_OR_OTHER||Difference in percentage|23.2|||<|0.0001|TWO_SIDED|95.0|15.3|31.2|||CMH chi-square test|||At Week 52: P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||31.2|15.3|<0.0001
72414062|NCT01458574|144337118|SUPERIORITY_OR_OTHER||Difference in percentage|30.0|||<|0.0001|TWO_SIDED|95.0|21.9|38.2|||CMH chi-square test|||At Week 52: P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||38.2|21.9|<0.0001
72414063|NCT01458574|144337119|SUPERIORITY_OR_OTHER||Difference in percentage|17.2|||<|0.0001|TWO_SIDED|95.0|10.6|23.7|||CMH chi-square test|||P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||23.7|10.6|<0.0001
72414064|NCT01458574|144337119|SUPERIORITY_OR_OTHER||Difference in percentage|20.8|||<|0.0001|TWO_SIDED|95.0|14.0|27.7|||CMH chi-square test|||P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||27.7|14.0|<0.0001
72414065|NCT01458574|144337120|SUPERIORITY_OR_OTHER||Difference in percentage|10.1||||0.0006|TWO_SIDED|95.0|4.5|15.7|||CMH chi-square test|||At Week 24: P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||15.7|4.5|0.0006
72588138|NCT03423173|144707017|OTHER||Seropositivity Rate Difference|1.13|||||TWO_SIDED|95.0|-6.9|8.95|||||95% CI for the differences in seropositivity rates between TDV lots were calculated using the Newcombe and Wilson method.|DENV-4 at Day 270||8.95|-6.90|
72588139|NCT03423173|144707017|OTHER||Seropositivity Rate Difference|2.64|||||TWO_SIDED|95.0|-4.68|10.18|||||95% CI for the differences in seropositivity rates between TDV lots were calculated using the Newcombe and Wilson method.|DENV-4 at Day 270||10.18|-4.68|
72414066|NCT01458574|144337120|SUPERIORITY_OR_OTHER||Difference in percentage|6.6||||0.0092|TWO_SIDED|95.0|1.5|11.7|||CMH chi-square test|||At Week 24: P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||11.7|1.5|0.0092
72588140|NCT03423173|144707018|OTHER||GMT Ratio|0.9|||||TWO_SIDED|95.0|0.56|1.42|||||ANOVA model was used for analysis, including natural logarithms of titers as a response variable and trial group as a factor.|DENV-1||1.42|0.56|
72588141|NCT03423173|144707018|OTHER||GMT Ratio|0.81|||||TWO_SIDED|95.0|0.51|1.28|||||ANOVA model was used for analysis, including natural logarithms of titers as a response variable and trial group as a factor.|DENV-1||1.28|0.51|
72414067|NCT01458574|144337120|SUPERIORITY_OR_OTHER||Difference in percentage|10.6||||0.0004|TWO_SIDED|95.0|5.0|16.2|||CMH chi-square test|||At Week 52: P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||16.2|5.0|0.0004
72414068|NCT01458574|144337120|SUPERIORITY_OR_OTHER||Difference in percentage|11.2|||<|0.0001|TWO_SIDED|95.0|5.5|16.9|||CMH chi-square test|||At Week 52: P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||16.9|5.5|<0.0001
72414069|NCT01458574|144337121|SUPERIORITY_OR_OTHER||Difference in percentage|5.6||||0.0029|TWO_SIDED|95.0|2.1|9.0|||CMH chi-square test|||P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||9.0|2.1|0.0029
72588142|NCT03423173|144707018|OTHER||GMT Ratio|0.73|||||TWO_SIDED|95.0|0.46|1.16|||||ANOVA model was used for analysis, including natural logarithms of titers as a response variable and trial group as a factor.|DENV-1||1.16|0.46|
72588143|NCT03423173|144707018|OTHER||GMT Ratio|1.37|||||TWO_SIDED|95.0|1.02|1.86|||||ANOVA model was used for analysis, including natural logarithms of titers as a response variable and trial group as a factor.|DENV-2||1.86|1.02|
72588144|NCT03423173|144707018|OTHER||GMT Ratio|0.65|||||TWO_SIDED|95.0|0.48|0.87|||||ANOVA model was used for analysis, including natural logarithms of titers as a response variable and trial group as a factor.|DENV-2||0.87|0.48|
72588145|NCT03423173|144707018|OTHER||GMT ratio|0.89|||||TWO_SIDED|95.0|0.66|1.21|||||ANOVA model was used for analysis, including natural logarithms of titers as a response variable and trial group as a factor.|DENV-2||1.21|0.66|
72588146|NCT03423173|144707018|OTHER||GMT Ratio|1.4|||||TWO_SIDED|95.0|1.0|1.94|||||ANOVA model was used for analysis, including natural logarithms of titers as a response variable and trial group as a factor.|DENV-3||1.94|1.00|
72588147|NCT03423173|144707018|OTHER||GMT Ratio|0.88|||||TWO_SIDED|95.0|0.64|1.21|||||ANOVA model was used for analysis, including natural logarithms of titers as a response variable and trial group as a factor.|DENV-3||1.21|0.64|
72588148|NCT03423173|144707018|OTHER||GMT Ratio|1.23|||||TWO_SIDED|95.0|0.88|1.71|||||ANOVA model was used for analysis, including natural logarithms of titers as a response variable and trial group as a factor.|DENV-3||1.71|0.88|
72588149|NCT03423173|144707018|OTHER||GMT Ratio|0.83|||||TWO_SIDED|95.0|0.58|1.18|||||ANOVA model was used for analysis, including natural logarithms of titers as a response variable and trial group as a factor.|DENV-4||1.18|0.58|
72414070|NCT01458574|144337121|SUPERIORITY_OR_OTHER||Difference in percentage|3.0||||0.035|TWO_SIDED|95.0|0.3|5.8|||CMH chi-square test|||P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||5.8|0.3|0.0350
72588150|NCT03423173|144707018|OTHER||GMT Ratio|1.51|||||TWO_SIDED|95.0|1.07|2.14|||||ANOVA model was used for analysis, including natural logarithms of titers as a response variable and trial group as a factor.|DENV-4||2.14|1.07|
72588151|NCT03423173|144707018|OTHER||GMT Ratio|1.25|||||TWO_SIDED|95.0|0.88|1.78|||||ANOVA model was used for analysis, including natural logarithms of titers as a response variable and trial group as a factor.|DENV-4||1.78|0.88|
72588152|NCT01631149|144707026|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.7|STANDARD_DEVIATION|0.4|<|0.001|||||||t-test, 2 sided|||"The individual scores obtained during surgery were averaged.~The average values were compared using a t-test between treatments."||||<0.001
72588153|NCT01430403|144707043|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.48|STANDARD_ERROR_OF_MEAN|0.331||0.03|TWO_SIDED|95.0|0.25|0.92|||Odds Ratio|Adjusted for Site, dosing group and treatment step|Placebo serves as the reference group. Values \< 1 represent more exacerbations in the placebo arm.|Null hypothesis is that there is no difference between the arms. Power calculation is described in detail in the study protocol.||0.92|0.25|0.03
72588154|NCT01430403|144707044|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.73|STANDARD_ERROR_OF_MEAN|0.41||0.45|TWO_SIDED|95.0|0.33|1.64|||Odds Ratio|Adjusted for Site, dosing group and treatment step|ICS Boost serves as the reference group. Values \< 1 represent more exacerbations in the ICS arm.|Null hypothesis is that there is no difference between the arms. Power calculation is described in detail in the study protocol.||1.64|0.33|0.45
72588155|NCT01430403|144707045|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.53|||<|0.01|TWO_SIDED|95.0|2.38|5.22|||Chi-squared||Adjusted for site|||5.22|2.38|<0.01
72588156|NCT01430403|144707046|SUPERIORITY_OR_OTHER||Linear Regression|0.004||||0.94|TWO_SIDED|95.0|-0.1|0.11|||F-Test|||||0.11|-0.10|0.94
72588157|NCT01430403|144707046|SUPERIORITY_OR_OTHER||Linear Regression|-0.13||||0.33|TWO_SIDED|95.0|-0.4|0.13|||F-Test|||||0.13|-0.40|0.33
72588158|NCT01430403|144707047|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.06||||0.552|TWO_SIDED|95.0|0.87|1.31|||Chi-squared|||||1.31|0.87|0.552
72588159|NCT01430403|144707047|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.12||||0.37|TWO_SIDED|95.0|0.87|1.44|||Chi-squared|||||1.44|0.87|0.37
72588160|NCT01430403|144707048|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.52|STANDARD_ERROR_OF_MEAN|0.3||0.09|TWO_SIDED|95.0|-1.11|0.07|||Regression, Linear|Adjustments for randomization CASI, site, dosing group and treatment group step (2-4 as one step and 5 separately)||||0.07|-1.11|0.09
72588161|NCT01430403|144707049|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.26|STANDARD_ERROR_OF_MEAN|0.3||0.39|TWO_SIDED|95.0|-0.86|0.34|||Regression, Linear|Adjustments for randomization CASI, site and dosing group||||0.34|-0.86|0.39
72588162|NCT01430403|144707050|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.32|STANDARD_ERROR_OF_MEAN|1.58||0.84|TWO_SIDED|95.0|-3.42|2.78|||Regression, Linear|Adjustments for randomization FEV1 % predicted, site, dosing group and treatment group step (2-4 as one step and 5 separately)||||2.78|-3.42|0.84
72588163|NCT01430403|144707051|SUPERIORITY_OR_OTHER||Median Difference (Net)|2.37|STANDARD_ERROR_OF_MEAN|1.59||0.14|TWO_SIDED|95.0|-0.76|5.51|||Regression, Linear|Adjustments for randomization FEV1 % predicted, site and dosing group.||||5.51|-0.76|0.14
72588164|NCT01430403|144707052|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.25|STANDARD_ERROR_OF_MEAN|0.89||0.78|TWO_SIDED|95.0|-1.49|1.99|||Regression, Linear|Adjustments for randomization FEV1:FVCx100, site, dosing group and treatment group step (2-4 as one step and 5 separately)||||1.99|-1.49|0.78
72588165|NCT01430403|144707053|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.15|STANDARD_ERROR_OF_MEAN|0.89||0.2|TWO_SIDED|95.0|-0.61|2.91|||Regression, Linear|Adjustments for randomization FEV1:FVCx100, site and dosing group.||||2.91|-0.61|0.20
72588166|NCT01430403|144707054|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.11|STANDARD_ERROR_OF_MEAN|0.4||0.006|TWO_SIDED|95.0|0.32|1.9|||Regression, Linear|Adjustments for randomization ACT, site, dosing group and treatment group step (2-4 as one step and 5 separately)||||1.90|0.32|0.006
72588167|NCT01430403|144707055|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.05|STANDARD_ERROR_OF_MEAN|0.41||0.89|TWO_SIDED|95.0|-0.76|0.86|||Regression, Linear|Adjustments for randomization ACT, site and dosing group.||||0.86|-0.76|0.89
72588168|NCT01430403|144707056|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.71|STANDARD_ERROR_OF_MEAN|0.36||0.05|TWO_SIDED|95.0|0.0|1.41|||Regression, Linear|Adjustments for randomization C-ACT, site, dosing group and treatment group step (2-4 as one step and 5 separately)||||1.41|0.00|0.05
72588169|NCT01430403|144707057|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.58|STANDARD_ERROR_OF_MEAN|0.37||0.12|TWO_SIDED|95.0|-0.15|1.3|||Regression, Linear|Adjustments for randomization C-ACT, site and dosing group||||1.30|-0.15|0.12
72588170|NCT01430403|144707058|SUPERIORITY_OR_OTHER||Rate Ratio|0.72|STANDARD_ERROR_OF_MEAN|0.68||0.63|TWO_SIDED|95.0|0.19|0.72|||Negative Binomial Generalized Estimating|Adjustments for site, dosing group and treatment group step (2-4 as one step and 5 separately)||||0.72|0.19|0.63
72588171|NCT01430403|144707059|SUPERIORITY_OR_OTHER||Ratio|1.0|STANDARD_ERROR_OF_MEAN|0.63||0.99|TWO_SIDED|95.0|0.29|3.46|||Negative Binomial Generalized Estimating|Adjustments for site and dosing group||||3.46|0.29|0.99
72588172|NCT01430403|144707060|SUPERIORITY_OR_OTHER||Ratio|0.72|STANDARD_ERROR_OF_MEAN|0.32||0.31|TWO_SIDED|95.0|0.39|1.35|||Negative Binomial Generalized Estimating|Adjustments for site, dosing group and treatment group step (2-4 as one step and 5 separately)||||1.35|0.39|0.31
72588173|NCT01430403|144707061|SUPERIORITY_OR_OTHER||Ratio|0.48|STANDARD_ERROR_OF_MEAN|0.39||0.06|TWO_SIDED|95.0|0.23|1.02|||Negative Binomial Generalized Estimating|Adjustments for site and dosing group||||1.02|0.23|0.06
72588174|NCT01430403|144707062|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.18|STANDARD_ERROR_OF_MEAN|1.48||0.9|TWO_SIDED|95.0|-3.08|2.72|||Regression, Linear|Adjustments for site, dosing group and treatment group step (2-4 as one step and 5 separately)||||2.72|-3.08|0.90
72588175|NCT01430403|144707063|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.28|STANDARD_ERROR_OF_MEAN|1.52||0.86|TWO_SIDED|95.0|-3.26|2.71|||Regression, Linear|Adjustments for site and dosing group.||||2.71|-3.26|0.86
72588176|NCT04481789|144707065|OTHER|Estimates of least squares mean difference of log-transformed PK parameters between treatments were obtained with their 2-sided 90%CIs for the difference. These estimates and limits were then back-transformed to obtain ratios of least squares geometric means. If the 90%CIs lay entirely within the limits of 0.80 to 1.25, this would provide evidence of no effect of edaravone on the PK of rosuvastatin, sildenafil, and furosemide (LS Mean Ratio: Rosuvastatin + Edaravone / Rosuvastatin Alone).|LS Mean Ratio|1.02|||||TWO_SIDED|90.0|0.97|1.08||||||PK parameters of rosuvastatin, sildenafil, and furosemide alone and in the presence of edaravone were analyzed for the assessments of effect on PK of rosuvastatin, sildenafil, and furosemide by edaravone.||1.08|0.97|
72588177|NCT04481789|144707065|OTHER|Estimates of least squares mean difference of log-transformed PK parameters between treatments were obtained with their 2-sided 90%CIs for the difference. These estimates and limits were then back-transformed to obtain ratios of least squares geometric means. If the 90%CIs lay entirely within the limits of 0.80 to 1.25, this would provide evidence of no effect of edaravone on the PK of rosuvastatin, sildenafil, and furosemide (LS Mean Ratio: Sildenafil + Edaravone / Sildenafil Alone).|LS Mean Ratio|0.93|||||TWO_SIDED|90.0|0.88|0.99||||||PK parameters of rosuvastatin, sildenafil, and furosemide alone and in the presence of edaravone were analyzed for the assessments of effect on PK of rosuvastatin, sildenafil, and furosemide by edaravone.||0.99|0.88|
72588178|NCT04481789|144707065|OTHER|Estimates of least squares mean difference of log-transformed PK parameters between treatments were obtained with their 2-sided 90%CIs for the difference. These estimates and limits were then back-transformed to obtain ratios of least squares geometric means. If the 90%CIs lay entirely within the limits of 0.80 to 1.25, this would provide evidence of no effect of edaravone on the PK of rosuvastatin, sildenafil, and furosemide (LS Mean Ratio: Furosemide + Edaravone / Furosemide Alone).|LS Mean Ratio|1.03|||||TWO_SIDED|90.0|0.98|1.09||||||PK parameters of rosuvastatin, sildenafil, and furosemide alone and in the presence of edaravone were analyzed for the assessments of effect on PK of rosuvastatin, sildenafil, and furosemide by edaravone.||1.09|0.98|
72588179|NCT04481789|144707066|OTHER|Estimates of least squares mean difference of log-transformed PK parameters between treatments were obtained with their 2-sided 90%CIs for the difference. These estimates and limits were then back-transformed to obtain ratios of least squares geometric means. If the 90%CIs lay entirely within the limits of 0.80 to 1.25, this would provide evidence of no effect of edaravone on the PK of rosuvastatin, sildenafil, and furosemide (LS Mean Ratio: Rosuvastatin + Edaravone / Rosuvastatin).|LS Mean Ratio|0.98|||||TWO_SIDED|90.0|0.91|1.06||||||PK parameters of rosuvastatin, sildenafil, and furosemide alone and in the presence of edaravone were analyzed for the assessments of effect on PK of rosuvastatin, sildenafil, and furosemide by edaravone.||1.06|0.91|
72588180|NCT04481789|144707066|OTHER|Estimates of least squares mean difference of log-transformed PK parameters between treatments were obtained with their 2-sided 90%CIs for the difference. These estimates and limits were then back-transformed to obtain ratios of least squares geometric means. If the 90%CIs lay entirely within the limits of 0.80 to 1.25, this would provide evidence of no effect of edaravone on the PK of rosuvastatin, sildenafil, and furosemide (LS Mean Ratio: Sildenafil + Edaravone / Sildenafil Alone).|LS Mean Ratio|0.94|||||TWO_SIDED|90.0|0.8|1.1||||||PK parameters of rosuvastatin, sildenafil, and furosemide alone and in the presence of edaravone were analyzed for the assessments of effect on PK of rosuvastatin, sildenafil, and furosemide by edaravone.||1.10|0.80|
72588181|NCT04481789|144707066|OTHER|Estimates of least squares mean difference of log-transformed PK parameters between treatments were obtained with their 2-sided 90%CIs for the difference. These estimates and limits were then back-transformed to obtain ratios of least squares geometric means. If the 90%CIs lay entirely within the limits of 0.80 to 1.25, this would provide evidence of no effect of edaravone on the PK of rosuvastatin, sildenafil, and furosemide (LS Mean Ratio: Furosemide + Edaravone / Furosemide Alone).|LS Mean Ratio|1.08|||||TWO_SIDED|90.0|0.96|1.23||||||PK parameters of rosuvastatin, sildenafil, and furosemide alone and in the presence of edaravone were analyzed for the assessments of effect on PK of rosuvastatin, sildenafil, and furosemide by edaravone.||1.23|0.96|
72588182|NCT04481789|144707081|OTHER|Estimated difference in least squares means and corresponding 90%CI of log-transformed PK parameters were back transformed to obtain the estimate and CI of the geometric mean ratio of 1 Hour After a High-fat Meal condition to the fasted state.|LS Mean Ratio|0.842|||||TWO_SIDED|90.0|0.697|1.017||||||PK parameters of unchanged edaravone were analyzed for the assessments of food effect on PK.||1.017|0.697|
72588183|NCT04481789|144707081|OTHER|Estimated difference in least squares means and corresponding 90% CI of log-transformed PK parameters were back transformed to obtain the estimate and CI of the geometric mean ratio of 4 Hours After a High-fat Meal condition to the fasted state.|LS Mean Ratio|0.737|||||TWO_SIDED|90.0|0.61|0.891||||||PK parameters of unchanged edaravone were analyzed for the assessments of food effect on PK.||0.891|0.610|
72588184|NCT04481789|144707082|OTHER|Estimated difference in least squares means and corresponding 90% CI of log-transformed PK parameters were back transformed to obtain the estimate and CI of the geometric mean ratio of 1 Hour After a High-fat Meal condition to the fasted state.|LS Mean Ratio|0.657|||||TWO_SIDED|90.0|0.379|1.137||||||PK parameters of unchanged edaravone were analyzed for the assessments of food effect on PK.||1.137|0.379|
72588185|NCT04481789|144707082|OTHER|Estimated difference in least squares means and corresponding 90%CI of log-transformed PK parameters were back transformed to obtain the estimate and CI of the geometric mean ratio of 4 Hours After a High-fat Meal condition to the fasted state.|LS Mean Ratio|0.522|||||TWO_SIDED|90.0|0.301|0.903||||||PK parameters of unchanged edaravone were analyzed for the assessments of food effect on PK.||0.903|0.301|
72588186|NCT02751450|144707095|SUPERIORITY_OR_OTHER||Least Square (LS) Mean Difference|-1.02|||<|0.0001|TWO_SIDED|95.0|-1.15|-0.882|||ANCOVA|Change from baseline in Schiff Sensitivity Score as response and treatment as a factor and baseline Schiff as a covariate|Difference is first named dentifrice minus second named dentifrice such that a negative difference favours first named dentifrice.|All statistical analyses were conducted under the null hypothesis (H0) of no difference between treatments versus the alternate hypothesis (H1) of a difference between treatments.||-0.882|-1.150|<0.0001
72588187|NCT01290679|144707099|SUPERIORITY_OR_OTHER||Difference in proportions of SVR12|32.2|||<|0.001|TWO_SIDED|95.0|23.3|41.2|||Cochran-Mantel-Haenszel|||The null hypothesis is there is no difference in proportions of SVR12 between the treatment groups.||41.2|23.3|<0.001
72588188|NCT01290679|144707100|SUPERIORITY_OR_OTHER||Difference in proportions of SVRW72|29.3|||<|0.001|TWO_SIDED|95.0|20.2|38.5|||Cochran-Mantel-Haenszel|||The null hypothesis is there is no difference in proportions of SVRW72 between the treatment groups.||38.5|20.2|<0.001
72588189|NCT01290679|144707101|SUPERIORITY_OR_OTHER||Difference in proportions of SVR24|31.5|||<|0.001|TWO_SIDED|95.0|22.5|40.5|||Cochran-Mantel-Haenszel|||The null hypothesis is there is no difference in proportions of SVR24 between the treatment groups.||40.5|22.5|<0.001
72588190|NCT01290679|144707102|SUPERIORITY_OR_OTHER||Difference in proportions of SVR4|32.3|||<|0.001|TWO_SIDED|95.0|23.5|41.0|||Cochran-Mantel-Haenszel|||The null hypothesis is there is no difference in proportions of SVR4 between the treatment groups.||41.0|23.5|<0.001
72588191|NCT01290679|144707129|SUPERIORITY_OR_OTHER||Mean differences|-16.776|STANDARD_ERROR_OF_MEAN|6.3081||0.008|TWO_SIDED|95.0|-29.1502|-4.4025|||Piecewise Linear Model|||Fatigue Severity Score AUC60||-4.4025|-29.1502|0.008
72588192|NCT01290679|144707129|SUPERIORITY_OR_OTHER||Mean differences|-18.837|STANDARD_ERROR_OF_MEAN|7.4715||0.012|TWO_SIDED|95.0|-33.4933|-4.1801|||Piecewise Linear Model|||Fatigue Severity Score AUC72||-4.1801|-33.4933|0.012
72588193|NCT01290679|144707130|SUPERIORITY_OR_OTHER||Mean differences|-282.16|STANDARD_ERROR_OF_MEAN|105.4927||0.008|TWO_SIDED|95.0|-489.1252|-75.1949|||Piecewise Linear Model|||Impairment in Work Productivity AUC60||-75.1949|-489.1252|0.008
72588194|NCT01290679|144707130|SUPERIORITY_OR_OTHER||Mean differences|-324.363|STANDARD_ERROR_OF_MEAN|124.026||0.009|TWO_SIDED|95.0|-567.708|-81.0182|||Piecewise Linear Model|||Impairment in Work Productivity AUC72||-81.0182|-567.7080|0.009
72588195|NCT01290679|144707131|SUPERIORITY_OR_OTHER||Mean Differences|-282.436|STANDARD_ERROR_OF_MEAN|104.9894||0.007|TWO_SIDED|95.0|-488.415|-76.4566|||Piecewise linear model|||Impairment in Daily Activities AUC60||-76.4566|-488.4150|0.007
72414071|NCT01458574|144337122|SUPERIORITY_OR_OTHER||Difference in percentage|17.2|||<|0.0001|TWO_SIDED|95.0|10.3|24.0|||CMH chi-square test|||At Week 24: P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||24.0|10.3|<0.0001
72588196|NCT01290679|144707131|SUPERIORITY_OR_OTHER||Mean differences|-329.204|STANDARD_ERROR_OF_MEAN|123.408||0.008|TWO_SIDED|95.0|-571.3389|-87.0695|||Piecewise Linear Model|||Impairment in Daily Activities AUC72||-87.0695|-571.3389|0.008
72588197|NCT01290679|144707132|SUPERIORITY_OR_OTHER||Mean differences|-186.852|STANDARD_ERROR_OF_MEAN|121.4741||0.125|TWO_SIDED|95.0|-425.4109|51.7059|||Piecewise linear model|||Time Missed from Work AUC60||51.7059|-425.4109|0.125
72588198|NCT01290679|144707132|SUPERIORITY_OR_OTHER||Mean differences|-188.202|STANDARD_ERROR_OF_MEAN|141.1702||0.183|TWO_SIDED|95.0|-465.507|89.104|||Piecewise linear model|||Time Missed from Work AUC72||89.1040|-465.5070|0.183
72588199|NCT00943150|144707149|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Regression, Linear|||||||<0.001
72414072|NCT01458574|144337122|SUPERIORITY_OR_OTHER||Difference in percentage|15.3|||<|0.0001|TWO_SIDED|95.0|8.5|22.0|||CMH chi-square test|||At Week 24: P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||22.0|8.5|<0.0001
72588200|NCT00943150|144707150|SUPERIORITY_OR_OTHER|||||||0.33||95.0|||||ANOVA|||CD3+ at 0 weeks||||0.33
72588201|NCT00943150|144707150|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||ANOVA|||CD3+ at 3 weeks||||0.02
72588202|NCT00943150|144707150|SUPERIORITY_OR_OTHER|||||||0.71||95.0|||||ANOVA|||CD3+ at 6 weeks||||0.71
72588203|NCT00943150|144707150|SUPERIORITY_OR_OTHER|||||||0.67||95.0|||||ANOVA|||CD68+ at 0 weeks||||0.67
72588204|NCT00943150|144707150|SUPERIORITY_OR_OTHER|||||||0.01||95.0|||||ANOVA|||CD68+ at 3 weeks||||0.01
72588205|NCT00943150|144707150|SUPERIORITY_OR_OTHER|||||||0.48||95.0|||||ANOVA|||CD68+ at 6 weeks||||0.48
72588206|NCT00943150|144707151|SUPERIORITY_OR_OTHER|||||||0.1128||95.0|||||Exact Wilcoxon rank-sum test|||||||0.1128
72588207|NCT00943150|144707152|SUPERIORITY_OR_OTHER|||||||0.0898||95.0|||||Exact Wilcoxon test|||||||0.0898
72588208|NCT00943150|144707153|SUPERIORITY_OR_OTHER|||||||0.076||95.0|||||Exact Wilcoxon test|||Intraoperative narcotic use comparison||||0.0760
72588209|NCT00943150|144707153|SUPERIORITY_OR_OTHER|||||||0.59||95.0|||||Exact Wilcoxon test|||Postoperative narcotic use comparison||||0.5900
72588210|NCT00943150|144707154|SUPERIORITY_OR_OTHER|||||||0.4589||95.0|||||Exact Wilcoxon test|||||||0.4589
72588211|NCT00943150|144707155|SUPERIORITY_OR_OTHER|||||||0.999||95.0|||||Exact Wilcoxon test|||||||0.999
72588212|NCT00943150|144707156|SUPERIORITY_OR_OTHER|||||||0.0412||95.0|||||Exact Wilcoxon test|||||||0.0412
72588213|NCT03315286|144707160|SUPERIORITY|||||||0.8|||||||t-test, 2 sided|||||||0.8
72588214|NCT03315286|144707161|SUPERIORITY|||||||0.03|||||||t-test, 2 sided|||||||0.03
72588215|NCT03315286|144707162|SUPERIORITY|||||||0.6|||||||t-test, 2 sided|||Baseline results are reported here.||||0.6
72588216|NCT03315286|144707162|SUPERIORITY|||||||0.3|||||||t-test, 2 sided|||6 month data is reported here||||0.3
72588217|NCT03315286|144707163|SUPERIORITY|||||||0.2|||||||t-test, 2 sided|||Baseline data is reported here.||||0.2
72588218|NCT03315286|144707163|SUPERIORITY|||||||0.4|||||||t-test, 2 sided|||6 month data is reported here||||0.4
72588219|NCT03315286|144707164|SUPERIORITY|||||||0.07|||||||t-test, 2 sided|||baseline data is reported here||||0.07
72588220|NCT03315286|144707164|SUPERIORITY|||||||0.0002|||||||t-test, 2 sided|||6 month data is reported here||||0.0002
72588221|NCT03075891|144707166|SUPERIORITY|||||||0.032|||||||Cochran-Mantel-Haenszel|||||||0.032
72588222|NCT00828568|144707194|NON_INFERIORITY_OR_EQUIVALENCE|The 90% confidence limit around the difference in proportion of patients considered a Treatment Success between test and reference products was calculated using Blackwelder's method with Yate's continuity correction. If the 90% confidence interval for the test to reference ratio for the primary endpoint was within -0.20 to +0.20, then the test product would have been declared therapeutically equivalent to the reference product.|Mean Difference (Final Values)|4.85||||||90.0|-5.37|15.08||||||||15.08|-5.37|
72588223|NCT00828568|144707196|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Fisher Exact|||||||<0.0001
72588224|NCT00828568|144707196|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Fisher Exact|||||||<.0001
72588225|NCT02477332|144707202|SUPERIORITY||Estimated target dose|32.5|||<|0.05|TWO_SIDED|60.0|27.5|42.5|||Regression, Logistic|Target dose was based on this estimated dose response. The 60% CI included the 20 - 80th percentile of target dose estimated in the bootstrap samples.|Min dose with effect size \>15%|||42.5|27.5|<.05
72588226|NCT02549287|144707226|SUPERIORITY||Odds Ratio, log|0.55||||0.12|TWO_SIDED|95.0|-0.11|1.2||Group by time interaction effect reported here.|Marginal Model (e.g., GEE)|||Intent-to-treat (ITT) framework (multiple imputation used), Multilevel model applied.||1.20|-0.11|0.12
72588227|NCT02549287|144707227|SUPERIORITY||Odds Ratio, log|0.41||||0.14|TWO_SIDED|95.0|-0.2|1.03||Group by time interaction effect reported here.|Marginal Model (e.g., GEE)|||Intent-to-treat (ITT) framework (multiple imputation used), Multilevel model applied.||1.03|-0.20|0.14
72588228|NCT02549287|144707228|SUPERIORITY||Odds Ratio, log|0.44||||0.2|TWO_SIDED|95.0|-0.2|1.07||Group by time interaction effect reported here.|Marginal Model (e.g., GEE)|||Intent-to-treat (ITT) framework (multiple imputation used), Multilevel model applied.||1.07|-0.20|0.20
72588229|NCT02549287|144707229|SUPERIORITY||Odds Ratio, log|-0.07||||0.77|TWO_SIDED|95.0|-0.58|0.43||Group by time interaction effect reported here.|Marginal Model (e.g., GEE)|||Intent-to-treat (ITT) framework (multiple imputation used), Multilevel model applied.||0.43|-0.58|0.77
72414073|NCT01458574|144337122|SUPERIORITY_OR_OTHER||Difference in percentage|15.7|||<|0.0001|TWO_SIDED|95.0|8.8|22.5|||CMH chi-square test|||At Week 52: P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||22.5|8.8|<0.0001
72588230|NCT02549287|144707230|SUPERIORITY||Odds Ratio, log|0.35||||0.29|TWO_SIDED|95.0|-0.27|0.97|||Marginal Model (e.g., GEE)|||Intent-to-treat (ITT) framework (multiple imputation used), Multilevel model applied.||0.97|-0.27|0.29
72588231|NCT02549287|144707231|SUPERIORITY||Odds Ratio, log|0.49||||0.15|TWO_SIDED|95.0|-0.08|1.06||Other \[Marginal Model (e.g., GEE)\]|Marginal Model (e.g., GEE)|||Intent-to-treat (ITT) framework (multiple imputation used), Multilevel model applied.||1.06|-0.08|0.15
72588232|NCT02549287|144707232|SUPERIORITY||Odds Ratio, log|-0.11||||0.61|TWO_SIDED|95.0|-0.73|0.52||Group by time interaction effect reported here.|Marginal Model (e.g., GEE)|||Intent-to-treat (ITT) framework (multiple imputation used), Multilevel model applied.||0.52|-0.73|0.61
72588233|NCT02549287|144707233|SUPERIORITY||Odds Ratio, log|-0.22||||0.47|TWO_SIDED|95.0|-0.76|0.32||Group by time interaction effect reported here.|Marginal Model (e.g., GEE)|||Intent-to-treat (ITT) framework (multiple imputation used), Multilevel model applied.||0.32|-0.76|0.47
72588234|NCT02549287|144707234|SUPERIORITY||Slope|-0.75||||0.65|TWO_SIDED|95.0|-3.7|2.2||Group by time interaction effect reported here.|Marginal Model (e.g., GEE)|||Intent-to-treat (ITT) framework (multiple imputation used), Multilevel model applied.||2.20|-3.70|0.65
72588235|NCT02549287|144707235|SUPERIORITY||Odds Ratio, log|0.05||||0.64|TWO_SIDED|95.0|-0.59|0.69||Group by time interaction effect reported here.|Marginal Model (e.g., GEE)|||Intent-to-treat (ITT) framework (multiple imputation used), Multilevel model applied.||0.69|-0.59|0.64
72588236|NCT02549287|144707236|SUPERIORITY||Odds Ratio, log|-0.25||||0.44|TWO_SIDED|95.0|-0.79|0.29||Group by time interaction effect reported here.|Marginal Model (e.g., GEE)|||Intent-to-treat (ITT) framework (multiple imputation used), Multilevel model applied.||0.29|-0.79|0.44
72588237|NCT02549287|144707237|SUPERIORITY||Odds Ratio, log|0.25||||0.47|TWO_SIDED|95.0|-0.39|0.89||Group by time interaction effect reported here.|Marginal Model (e.g., GEE)|||Intent-to-treat (ITT) framework (multiple imputation used), Multilevel model applied.||0.89|-0.39|0.47
72588238|NCT02549287|144707238|SUPERIORITY||Slope|-0.18||||0.63|TWO_SIDED|95.0|-3.57|3.22||Group by time interaction effect reported here.|Marginal Model (e.g., GEE)|||Intent-to-treat (ITT) framework (multiple imputation used), Multilevel model applied.||3.22|-3.57|0.63
72588239|NCT01075256|144707319|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-2.1||||0.3628|TWO_SIDED|95.0|-6.7|2.46||No adjustment was made for multiple comparisons.|ANCOVA|ANCOVA model adjusted for baseline, treatment and number of sensitive teeth and years of sensitivity|Difference was first named treatment minus second named treatment such that a positive difference favors the first named treatment.|The null hypothesis was no diference between treatments in comparison. Statistical tests were 2-sided at 5% significance level.||2.46|-6.70|0.3628
72588240|NCT01075256|144707319|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.2||||0.9361|TWO_SIDED|95.0|-4.45|4.83||No adjustment was made for multiple comparisons.|ANCOVA|ANCOVA model adjusted for baseline, treatment and number of sensitive teeth and years of sensitivity.|Difference was first named treatment minus second named treatment such that a positive difference favors the first named treatment.|The null hypothesis was no difference between treatments in comparison. Statistical tests were 2-sided at 5% significance level.||4.83|-4.45|0.9361
72588241|NCT01075256|144707319|SUPERIORITY_OR_OTHER||Adjusted Mean difference|2.3||||0.3257|TWO_SIDED|95.0|-2.31|6.92||No adustment was made for multiple comparisons.|ANCOVA|ANCOVA model adjusted for baseline, treatment and number of sensitive teeth and years of sensitivity.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|The null hypothesis was no difference between treatments in comparison. Statistical tests were 2-sided at 5% significance level.||6.92|-2.31|0.3257
72588242|NCT01075256|144707320|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.0||||0.6674|TWO_SIDED|95.0|-5.73|3.68||No adjustment was made for multiple comparisons.|ANCOVA|ANCOVA model adjusted for baseline, treatment and number of sensitive teeth and years of sensitivity|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|The null hypothesis was no difference between treatments in comparison. Statistical tests were 2-sided at 5% significance level.||3.68|-5.73|0.6674
72588243|NCT01075256|144707320|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.0||||0.9888|TWO_SIDED|95.0|-4.74|4.81||No adjustments for multiple comparisons.|ANCOVA|ANCOVA model adjusted for baseline, treatment and number of sensitive teeth and years of sensitivity|Difference is the high concentration minus placebo such that a positive difference favors the first named treatment.|The null hypothesis was no difference between treatments in comparison. Statistical tests were 2-sided at 5% significance level.||4.81|-4.74|0.9888
72588244|NCT01075256|144707320|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|1.1||||0.6599|TWO_SIDED|95.0|-3.69|5.81||No adjustments for multiple comparisons.|ANCOVA|ANCOVA model adjusted for baseline, treatment and number of sensitive teeth and years of sensitivity|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|The null hypothesis was no difference between treatments in comparison. Statistical tests were 2-sided at 5% significance level.||5.81|-3.69|0.6599
72588245|NCT01075256|144707321|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.1||||0.9759|TWO_SIDED|95.0|-6.34|6.54||No adjustments for multiple comparisons|ANCOVA|ANCOVA model adjusted for baseline, treatment and number of sensitive teeth and years of sensitivity|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|The null hypothesis was no difference between treatments in comparison. Statistical tests were 2-sided at 5% significance level.||6.54|-6.34|0.9759
72588246|NCT01075256|144707321|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.5||||0.8903|TWO_SIDED|95.0|-6.97|6.06||No adjustments for multiple comparisons.|ANCOVA|ANCOVA model adjusted for baseline, treatment and number of sensitive teeth and years of sensitivity|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|The null hypothesis was no difference between treatments in comparison. Statistical tests were 2-sided at 5% significance level.||6.06|-6.97|0.8903
72588247|NCT01075256|144707321|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.6||||0.8662|TWO_SIDED|95.0|-7.04|5.93||No adjustments for multiple comparisons|ANCOVA|ANCOVA model adjusted for baseline, treatment and number of sensitive teeth and years of sensitivity|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.||5.93|-7.04|0.8662
72588248|NCT01075256|144707322|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.6||||0.8419|TWO_SIDED|95.0|-6.93|5.66||No adjustments for multiple comparisons.|ANCOVA|ANCOVA model adjusted for baseline, treatment and number of sensitive teeth and years of sensitivity|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments in comparison. Statistical tests were 2-sided at 5% significance level.||5.66|-6.93|0.8419
72588249|NCT01075256|144707322|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.3||||0.9147|TWO_SIDED|95.0|-6.03|6.72||No adjustments for multiple comparisons.|ANCOVA|ANCOVA model adjusted for baseline, treatment and number of sensitive teeth and years of sensitivity|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments in comparison. Statistical tests were 2-sided at 5% significance level.||6.72|-6.03|0.9147
72588250|NCT01075256|144707322|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|1.0||||0.76|TWO_SIDED|95.0|-5.36|7.33||No adjustments for multiple comparisons.|ANCOVA|ANCOVA model adjusted for baseline, treatment and number of sensitive teeth and years of sensitivity|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments in comparison. Statistical tests were 2-sided at 5% significance level.||7.33|-5.36|0.7600
72588251|NCT01075256|144707323|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.5||||0.9124|TWO_SIDED|95.0|-8.28|9.24||No adjustment was made for multiple comparisons.|ANCOVA|ANCOVA model adjusted for baseline, treatment and number of sensitive teeth and years of sensitivity|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments in comparison. Statistical tests were 2-sided at 5% significance level.||9.24|-8.28|0.9124
72588252|NCT01075256|144707323|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.5||||0.9083|TWO_SIDED|95.0|-9.13|8.14||No adjustment was made for multiple comparisons.|ANCOVA|ANCOVA model adjusted for baseline, treatment and number of sensitive teeth and years of sensitivity|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments in comparison. Statistical tests were 2-sided at 5% significance level||8.14|-9.13|0.9083
72588253|NCT01075256|144707323|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.0||||0.8231|TWO_SIDED|95.0|-9.73|7.77||No adjustment was made for multiple comparisons.|ANCOVA|ANCOVA model adjusted for baseline, treatment and number of sensitive teeth and years of sensitivity|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments in comparison. Statistical tests were 2-sided at 5% significance level.||7.77|-9.73|0.8231
72588254|NCT01075256|144707324|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|3.4||||0.5946|TWO_SIDED|95.0|-9.32|16.09||No adjustment was made for multiple comparisons.|ANCOVA|ANCOVA model adjusted for baseline, treatment and number of sensitive teeth and years of sensitivity|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments in comparison. Statistical tests were 2-sided at 5% significance level.||16.09|-9.32|0.5946
72588255|NCT01075256|144707324|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.0||||0.9944|TWO_SIDED|95.0|-12.51|12.6||No adjustment was made for multiple comparisons.|ANCOVA|ANCOVA model adjusted for baseline, treatment and number of sensitive teeth and years of sensitivity|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments in comparison. Statistical tests were 2-sided at 5% significance level.||12.60|-12.51|0.9944
72588256|NCT01075256|144707324|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-3.3||||0.5998|TWO_SIDED|95.0|-16.06|9.38||No adjustment was made for multiple comparisons.|ANCOVA|ANCOVA model adjusted for baseline, treatment and number of sensitive teeth and years of sensitivity|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments in comparison. Statistical tests were 2-sided at 5% significance level.||9.38|-16.06|0.5998
72588257|NCT01075256|144707325|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.2||||0.7952|TWO_SIDED|95.0|-10.51|8.09||No adjustment was made for multiple comparisons.|ANCOVA|ANCOVA model adjusted for baseline, treatment and number of sensitive teeth and years of sensitivity|Difference is first named treatment minus second named treatment such that a positive difference favours the first named treatment.|Null hypothesis was no difference between treatments in comparison. Statistical tests were 2-sided at 5% significance level.||8.09|-10.51|0.7952
72588258|NCT01075256|144707325|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-2.4||||0.601|TWO_SIDED|95.0|-11.56|6.76||No adjustment was made for multiple comparisons.|ANCOVA|ANCOVA model adjusted for baseline, treatment and number of sensitive teeth and years of sensitivity|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|The null hypothesis was no difference between treatments in comparison. Statistical tests were 2-sided at 5% significance level.||6.76|-11.56|0.6010
72588259|NCT01075256|144707325|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.2||||0.7976|TWO_SIDED|95.0|-10.48|8.1||No adjustment was made for multiple comparisons.|ANCOVA|ANCOVA model adjusted for baseline, treatment and number of sensitive teeth and years of sensitivity|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments in comparison. Statistical tests were 2-sided at 5% significance level.||8.10|-10.48|0.7976
72588260|NCT01075256|144707326|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.7||||0.906|TWO_SIDED|95.0|-10.38|11.68||No adjustment was made for multiple comparisons.|ANCOVA|ANCOVA model adjusted for baseline, treatment and number of sensitive teeth and years of sensitivity|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments in comparison. Statistical tests were 2-sided at 5% significance level.||11.68|-10.38|0.9060
72588261|NCT01075256|144707326|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.7||||0.7575|TWO_SIDED|95.0|-12.63|9.25||No adjustment was made for multiple comparisons.|ANCOVA|ANCOVA model adjusted for baseline, treatment and number of sensitive teeth and years of sensitivity|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments in comparison. Statistical tests were 2-sided at 5% significance level.||9.25|-12.63|0.7575
72588262|NCT01075256|144707326|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-2.3||||0.6727|TWO_SIDED|95.0|-13.42|8.73||No adjustment was made for multiple comparisons.|ANCOVA|ANCOVA model adjusted for baseline, treatment and number of sensitive teeth and years of sensitivity|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments in comparison. Statistical tests were 2-sided at 5% significance level.||8.73|-13.42|0.6727
72588263|NCT00789698|144707400|NON_INFERIORITY_OR_EQUIVALENCE|This is a non-inferiority analysis. Lurasidone will be declared as effective as quetiapine XR in preventing relapse if the upper bound of a 2-sided 95% confidence limit for the hazard ration of lurasidone vs. quetiapine is no greater than an equivalence hazard ratio margin of 1.93.|Hazard Ratio (HR)|0.728|||||TWO_SIDED|95.0|0.41|1.295||There is no hypothesis tested. Since this was a non-inferiority study, the upper bound of the 95% CI for the hazard ratio was compared to the pre-specified margin of 1.93 to demonstrate the non-inferiority of lurasidone compared to Quetiapine XR.|COX Proportional Hazards Model|||Comparison of time to relapse of psychotic symptoms between LUR-LUR and QXR-QXR as analyzed using the Cox proportional-hazards model.||1.295|0.410|
72588264|NCT00596817|144707404|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.01||||0.0035|TWO_SIDED|95.0|1.26|3.21|||Cox-model|Cox-model using an exact method to handle ties||||3.21|1.26|0.0035
72588265|NCT00596817|144707405|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.09||||0.001|TWO_SIDED|95.0|1.35|3.23||A nominal p-value is provided.|Cox-Model|||||3.23|1.35|0.0010
72588266|NCT00596817|144707406|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.06|STANDARD_ERROR_OF_MEAN|0.66||0.002|TWO_SIDED|95.0|-3.36|-0.77||A nominal p-value is provided.|ANCOVA|||||-0.77|-3.36|0.0020
72588267|NCT00596817|144707407|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.31|STANDARD_ERROR_OF_MEAN|0.55||0.0171|TWO_SIDED|95.0|-2.39|-0.24||A nominal p-value is provided.|ANCOVA|||||-0.24|-2.39|0.0171
72588268|NCT00596817|144707408|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.12|STANDARD_ERROR_OF_MEAN|0.6||0.0612|TWO_SIDED|95.0|-2.3|0.05||A nominal p-value is provided.|ANCOVA|||||0.05|-2.30|0.0612
72588269|NCT00596817|144707409|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.38|STANDARD_ERROR_OF_MEAN|0.1||0.0002|TWO_SIDED|95.0|-0.57|-0.18||A nominal p-value is provided.|ANCOVA|||||-0.18|-0.57|0.0002
72588270|NCT00596817|144707410|SUPERIORITY_OR_OTHER||Difference|6.35||||0.025|TWO_SIDED|95.0|1.13|11.56||A nominal p-value is provided.|Fisher Exact|||||11.56|1.13|0.025
72588271|NCT00596817|144707411|SUPERIORITY_OR_OTHER||Difference|12.13||||0.002|TWO_SIDED|95.0|4.73|19.52||A nominal p-value is provided.|Fisher Exact|||||19.52|4.73|0.002
72588272|NCT00596817|144707412|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.67|STANDARD_ERROR_OF_MEAN|0.73||0.3642|TWO_SIDED|95.0|-2.12|0.78||A nominal p-value is provided.|ANCOVA|||||0.78|-2.12|0.3642
72588273|NCT00869622|144707414|SUPERIORITY_OR_OTHER|||||||0.0229|TWO_SIDED||||||Fisher Exact|||||||0.0229
72588274|NCT02986282|144707434|OTHER||Median Difference (Final Values)|-0.0600326|||<|0.05|TWO_SIDED|95.0|-0.0799661|-0.0449876|||Wilcoxon (Mann-Whitney)|||It was calculated that the study sample size of 79 subjects would be needed to detect a difference of 0.1 in the ABI measured in sinus rhythm and during atrial fibrillation, with a two-tailed α of 0.05 and a (1-β) of 0.90. Our initial estimate of sample size of 115 patients incorporated an assumption of dropout. Intra-observer variability was calculated using intra-class correlation coefficient.||-0.0449876|-0.0799661|<0.05
72588275|NCT02986282|144707435|OTHER||Median Difference (Final Values)|-0.0249837|||<|0.05|TWO_SIDED|95.0|-0.039992|-0.0100226|||Wilcoxon (Mann-Whitney)|||||-0.0100226|-0.039992|<0.05
72588276|NCT01068730|144707462|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was concluded if the 90% confidence intervals (CIs) for the test-to-reference ratios (B/A) and (D/C) of geometric means were entirely contained within 80% to 125% for both Cmax and AUC0-inf.|Ratio (%) of Geometric LS Means|102.58|||||TWO_SIDED|95.0|99.07|106.23|||||Ratio=Treatment B/Treatment A. Geometric least squares (LS) means values are presented in other statistical analysis entries.|If there was no difference between the bioavailabilities of metformin from the 500-mg or 1000-mg Glucophage tablets manufactured by BMS and 500-mg or 1000-mg Diabex tablets manufactured in Australia by Alphapharm, then 20 subjects would have provided 99% power to conclude bioequivalence (BE) with respect to Cmax and AUC0-inf. If there was a 5% difference, then 20 subjects would have provided 97% and 99% power to conclude BE with respect to Cmax and AUC0-inf, respectively.||106.23|99.07|
72588277|NCT01068730|144707462|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was concluded if the 90% confidence intervals (CIs) for the test-to-reference ratios (B/A) and (D/C) of geometric means were entirely contained within 80% to 125% for both Cmax and AUC0-inf.|Ratio (%) of Geometric LS Means|99.67|||||TWO_SIDED|95.0|96.16|103.31|||||Ratio=Treatment D/Treatment C. Geometric LS means values are presented in other statistical analysis entries.|If there was no difference between the bioavailabilities of metformin from the 500-mg or 1000-mg Glucophage tablets manufactured by BMS and 500-mg or 1000-mg Diabex tablets manufactured in Australia by Alphapharm, then 20 subjects would have provided 99% power to conclude BE with respect to Cmax and AUC0-inf. If there was a 5% difference, then 20 subjects would have provided 97% and 99% power to conclude BE with respect to Cmax and AUC0-inf, respectively.||103.31|96.16|
72588278|NCT01068730|144707462|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean (ng*hr/mL)|7062.8||||||||||||||Geometric least squares means for Treatment A||||
72588279|NCT01068730|144707462|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean (ng*hr/mL)|7245.2||||||||||||||Geometric least squares means for Treatment B||||
72588280|NCT01068730|144707462|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean (ng*hr/mL)|11680.0||||||||||||||Geometric least squares means for Treatment C||||
72588281|NCT01068730|144707462|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean (ng*hr/mL)]|11641.0||||||95.0||||||||Geometric least squares means for Treatment D||||
72588282|NCT01068730|144707463|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was concluded if the 90% confidence intervals (CIs) for the test-to-reference ratios (B/A) and (D/C) of geometric means were entirely contained within 80% to 125% for both Cmax and AUC0-inf.|Ratio (%) of Geometric LS Means|101.12|||||TWO_SIDED|95.0|96.36|106.11|||||Ratio=Treatment B/Treatment A. Geometric LS means values are presented in other statistical analysis entries.|If there was no difference between the bioavailabilities of metformin from the 500-mg or 1000-mg Glucophage tablets manufactured by BMS and 500-mg or 1000-mg Diabex tablets manufactured in Australia by Alphapharm, then 20 subjects would have provided 99% power to conclude BE with respect to Cmax and AUC0-inf. If there was a 5% difference, then 20 subjects would have provided 97% and 99% power to conclude BE with respect to Cmax and AUC0-inf, respectively.||106.11|96.36|
72588283|NCT01068730|144707463|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was concluded if the 90% confidence intervals (CIs) for the test-to-reference ratios (B/A) and (D/C) of geometric means were entirely contained within 80% to 125% for both Cmax and AUC0-inf.|Ratio (%) of Geometric LS Means|98.65|||||TWO_SIDED|95.0|93.94|103.59|||||Ratio=Treatment B/Treatment A. Geometric LS means values are presented in other statistical analysis entries.|If there was no difference between the bioavailabilities of metformin from the 500-mg or 1000-mg Glucophage tablets manufactured by BMS and 500-mg or 1000-mg Diabex tablets manufactured in Australia by Alphapharm, then 20 subjects would have provided 99% power to conclude BE with respect to Cmax and AUC0-inf. If there was a 5% difference, then 20 subjects would have provided 97% and 99% power to conclude BE with respect to Cmax and AUC0-inf, respectively.||103.59|93.94|
72588284|NCT01068730|144707463|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean (ng/mL)|1013.6||||||||||||||Geometric least squares means for Treatment A||||
72588285|NCT01068730|144707463|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean (ng/mL)|1024.9||||||||||||||Geometric least squares means for Treatment B||||
72588286|NCT01068730|144707463|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean (ng/mL)|1643.8||||||||||||||Geometric least squares means for Treatment C||||
72588287|NCT01068730|144707463|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean (ng/mL)|1621.6||||||||||||||Geometric least squares means for Treatment D||||
72588288|NCT01068730|144707473|SUPERIORITY_OR_OTHER||Ratio (%) of Geometric LS Means|103.19|||||TWO_SIDED|95.0|99.75|106.75|||||Ratio=Treatment B/Treatment A. Geometric LS means values are presented in other statistical analysis entries.|||106.75|99.75|
72588289|NCT01068730|144707473|SUPERIORITY_OR_OTHER||Ratio (%) of Geometric LS Means|99.44|||||TWO_SIDED|95.0|96.08|102.92|||||Ratio=Treatment D/Treatment C. Geometric LS means values are presented in other statistical analysis entries.|||102.92|96.08|
72588290|NCT01068730|144707473|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean (ng*hr/mL)|6907.1||||||||||||||Geometric least squares means for Treatment A||||
72414074|NCT01458574|144337122|SUPERIORITY_OR_OTHER||Difference in percentage|19.8|||<|0.0001|TWO_SIDED|95.0|12.7|27.0|||CMH chi-square test|||At Week 52: P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||27.0|12.7|<0.0001
72588291|NCT01068730|144707473|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean (ng*hr/mL)|7127.4||||||95.0||||||||Geometric least squares means for Treatment B||||
72588292|NCT01068730|144707473|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean (ng*hr/mL)|11391.0||||||||||||||Geometric least squares means for Treatment C||||
72588293|NCT01068730|144707473|SUPERIORITY_OR_OTHER||[Geometric Least Squares Mean (ng*hr/mL)|11327.0||||||||||||||Geometric least squares means for Treatment D||||
72588294|NCT01113385|144707474|SUPERIORITY_OR_OTHER|||||||0.009||||||p value reflects the difference in mean FSPF pre vs post galactose treatment.|t-test, 2 sided|||||||0.009
72588295|NCT01560234|144707519|SUPERIORITY_OR_OTHER||Slope|0.81|STANDARD_ERROR_OF_MEAN|0.1|||TWO_SIDED|90.0|0.63|1.0|||Regression, Linear||AUC (nmol\*h/L) 5 to 30 μg|||1.00|0.63|
72588296|NCT01560234|144707520|SUPERIORITY_OR_OTHER||Slope|0.84|STANDARD_ERROR_OF_MEAN|0.11|||TWO_SIDED|90.0|0.65|1.04|||Regression, Linear||AUC(0-t) (nmol\*h/L) 5 to 30 μg|||1.04|0.65|
72588297|NCT01560234|144707521|SUPERIORITY_OR_OTHER||Slope|0.95|STANDARD_ERROR_OF_MEAN|0.05|||TWO_SIDED|90.0|0.87|1.04|||Regression, Linear||Cmax (nmol/L) 0.5 to 30 μg|||1.04|0.87|
72588298|NCT01560234|144707522|SUPERIORITY_OR_OTHER||Percentage of Placebo|99.75|||||TWO_SIDED|95.0|65.76|151.32|||ANCOVA||Cohort 1/0.15 ug vs Placebo|24 hour Plasma||151.32|65.76|
72588299|NCT01560234|144707522|SUPERIORITY_OR_OTHER||Percentage of Placebo|92.99|||||TWO_SIDED|95.0|61.21|141.27|||ANCOVA||Cohort 2/1.5ug vs Placebo|24 hour Plasma||141.27|61.21|
72588300|NCT01560234|144707522|SUPERIORITY_OR_OTHER||Percentage of Placebo|145.83|||||TWO_SIDED|95.0|96.11|221.28|||ANCOVA||Cohort 4/5 ug vs Placebo|24 hour Plasma||221.28|96.11|
72588301|NCT01560234|144707522|SUPERIORITY_OR_OTHER||Percentage of Placebo|106.23|||||TWO_SIDED|95.0|66.42|169.93|||ANCOVA||Cohort 3/1.5 ug vs Placebo|24 hour Plasma||169.93|66.42|
72588302|NCT01560234|144707522|SUPERIORITY_OR_OTHER||Percentage of Placebo|223.76||||||95.0|144.98|345.35|||ANCOVA||Cohort 5/15 μg vs Placebo|24 hour plasma||345.35|144.98|
72588303|NCT01560234|144707522|SUPERIORITY_OR_OTHER||Percentage of Placebo|228.23|||||TWO_SIDED|95.0|150.36|346.41|||ANCOVA||Cohort 7/15 μg vs Placebo|24 hour plasma||346.41|150.36|
72588304|NCT01560234|144707522|SUPERIORITY_OR_OTHER||Percentage of Placebo|684.03|||||TWO_SIDED|95.0|495.31|944.65|||ANCOVA||Cohort 6 and 8/30 μg vs Placebo|24 hour plasma||944.65|495.31|
72588305|NCT01560234|144707523|SUPERIORITY_OR_OTHER||Percentage of Placebo|95.81|||||TWO_SIDED|95.0|72.7|126.28|||ANCOVA||Cohort 1/0.15 ug vs Placebo|48 hour plasma||126.28|72.70|
72588306|NCT01560234|144707523|SUPERIORITY_OR_OTHER||Percentage of Placebo|91.72|||||TWO_SIDED|95.0|69.53|121.0|||ANCOVA||Cohort 2/0.5 ug vs Placebo|48 hour plasma||121.00|69.53|
72588307|NCT01560234|144707523|SUPERIORITY_OR_OTHER||Percentage of Placebo|112.34|||||TWO_SIDED|95.0|82.3|153.35|||ANCOVA||Cohort 3/1.5 ug vs Placebo|48 hour Plasma||153.35|82.30|
72588308|NCT01560234|144707523|SUPERIORITY_OR_OTHER||Percentage of Placebo|120.0|||||TWO_SIDED|95.0|91.04|158.18|||ANCOVA||Cohort 4/5 ug vs Placebo|48 hour plasma||158.18|91.04|
72588309|NCT01560234|144707523|SUPERIORITY_OR_OTHER||Percentage of Placebo|102.67|||||TWO_SIDED|95.0|77.02|136.87|||ANCOVA||Cohort 5/15 ug vs Placebo|48 hour placebo||136.87|77.02|
72588310|NCT01560234|144707523|SUPERIORITY_OR_OTHER||Percentage of Placebo|146.86|||||TWO_SIDED|95.0|111.39|193.62|||ANCOVA||Cohort 7/15 ug vs Placebo|48 hour plasma||193.62|111.39|
72588311|NCT01560234|144707523|SUPERIORITY_OR_OTHER||Percentage of Placebo|240.04|||||TWO_SIDED|95.0|193.82|297.28|||ANCOVA||Cohort 6 and 8/30 ug|48 hour plasma||297.28|193.82|
72588312|NCT01560234|144707525|SUPERIORITY_OR_OTHER||Comparison of Placebo|114.87|||||TWO_SIDED|95.0|34.83|378.78|||ANCOVA||Cohort 1/0.15 ug vs Placebo|24 hour Sputum||378.78|34.83|
72588313|NCT01560234|144707525|SUPERIORITY_OR_OTHER||Comparison of Placebo|81.89|||||TWO_SIDED|95.0|24.96|268.7|||ANCOVA||Cohort 2/0.5 ug vs Placebo|24 hour Sputum||268.70|24.96|
72588314|NCT01560234|144707525|SUPERIORITY_OR_OTHER||Comparison of Placebo|81.55|||||TWO_SIDED|95.0|20.63|322.42|||ANCOVA||Cohort 3/1.5 ug vs Placebo|24 hour Sputum||322.42|20.63|
72588315|NCT01560234|144707525|SUPERIORITY_OR_OTHER||Comparison of Placebo|304.37|||||TWO_SIDED|95.0|76.61|1209.33|||ANCOVA||Cohort 4/5 ug vs Placebo|24 hour Sputum||1209.33|76.61|
72588316|NCT01560234|144707525|SUPERIORITY_OR_OTHER||Comparison of Placebo|193.8|||||TWO_SIDED|95.0|59.01|636.49|||ANCOVA||Cohort 5/15 μg vs Placebo|24 hour Sputum||636.49|59.01|
72588317|NCT01560234|144707525|SUPERIORITY_OR_OTHER||Comparison of Placebo|467.96|||||TWO_SIDED|95.0|142.77|1533.92|||ANCOVA||Cohort 7/15 μg vs Placebo|24 hour Sputum||1533.92|142.77|
72588318|NCT01560234|144707525|SUPERIORITY_OR_OTHER||Comparison of Placebo|1087.35|||||TWO_SIDED|95.0|317.19|3727.57|||ANCOVA||Cohort 6 and 8/30 μg vs Placebo|24 hour Sputum||3727.57|317.19|
72588319|NCT00083759|144707545|SUPERIORITY_OR_OTHER|||||||0.089||95.0|||||Cochran-Mantel-Haenszel|||||||0.089
72588320|NCT00083759|144707546|SUPERIORITY_OR_OTHER|||||||0.171||95.0|||||Cochran-Mantel-Haenszel|||||||0.171
72588321|NCT00083759|144707547|SUPERIORITY_OR_OTHER|||||||0.526||95.0|||||Cochran-Mantel-Haenszel|||||||0.526
72588322|NCT03567005|144707550|NON_INFERIORITY|The pre-specified non-inferiority margin is 0.05. With a sample size of 36 (18 per sequence group), there was approximately 80% power to reject the null hypothesis of inferiority in distance visual acuity with assumed standard deviation of 0.098 for paired difference (one-sided alpha=0.05).|Least Squares Mean (LSM) Difference|0.0|STANDARD_ERROR_OF_MEAN|0.008|||ONE_SIDED|95.0||0.02||||||||0.02||
72588323|NCT03567005|144707551|NON_INFERIORITY|The pre-specified non-inferiority margin is 1.0. With a sample size of 48 (24 per sequence group), there was approximately 80% power to reject the null hypothesis of inferiority in subjective overall vision with assumed standard deviation of 2.29 for paired differences (one-sided alpha=0.05).|LSM Difference|0.0|STANDARD_ERROR_OF_MEAN|0.15|||ONE_SIDED|95.0|-0.3||||||||||-0.3|
72588324|NCT01057810|144707552|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.11||||0.3667|TWO_SIDED|95.87|0.88|1.39|||Log Rank||Hazard ratio = ipilimumab over placebo|||1.39|0.88|0.3667
72588325|NCT01057810|144707553|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.67|||||TWO_SIDED|95.0|0.55|0.8|||||HR = ipilimumab over placebo|||0.80|0.55|
72588326|NCT01057810|144707554|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.65|||||TWO_SIDED|95.87|0.52|0.83|||||HR = Ipilimumab over placebo|||0.83|0.52|
72588327|NCT01057810|144707555|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.98|||||TWO_SIDED|95.87|0.71|1.35|||||HR = Ipilimumab over placebo|||1.35|0.71|
72588328|NCT02088905|144707559|SUPERIORITY|||||||0.08||||||No adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||Comparison of ECBI Problem Score between Week 18 scores, 1 sided test for Treatment Group Superiority||||.080
72588329|NCT02088905|144707559|SUPERIORITY|||||||0.026||||||No adjustment for multiple comparisons.|t-test, 1 sided|||Comparison of ECBI Intensity Score between Week 18 scores, 1 sided test for Treatment Group Superiority||||.026
72588330|NCT02088905|144707559|OTHER|Type III Tests of Fixed Effects|||||<|0.001||||||Mixed Model Analysis - Significance of Timepoint within the model in determining the effectiveness of assigned treatment.|Mixed Models Analysis|||Mixed Model Analysis of ECBI Intensity Scores, with variables of Timepoint, Treatment Assignment, and Timepoint\*Treatment Assignment interaction. Random intercept used.||||<.001
72588331|NCT02088905|144707559|OTHER|Type III Tests of Fixed Effects||||||0.182||||||Mixed Model Analysis - Significance of Treatment Assignment within the model in determining the effectiveness of assigned treatment.|Mixed Models Analysis|||Mixed Model Analysis of ECBI Intensity Scores, with variables of Timepoint, Treatment Assignment, and Timepoint\*Treatment Assignment interaction. Random intercept used.||||.182
72588332|NCT02088905|144707559|OTHER|Type III Tests of Fixed Effects||||||0.015||||||Mixed Model Analysis - Significance of Treatment Assignment and Timepoint Interaction Term within the model in determining the effectiveness of assigned treatment.|Mixed Models Analysis|||Mixed Model Analysis of ECBI Intensity Scores, with variables of Timepoint, Treatment Assignment, and Timepoint\*Treatment Assignment interaction. Random intercept used.||||.015
72588333|NCT02088905|144707560|SUPERIORITY|||||||0.203||||||No adjustment for multiple comparisons.|t-test, 1 sided|||Comparison of PSI Parental Distress between Week 18 scores, 1 sided test for Treatment Group Superiority||||.203
72588334|NCT02088905|144707560|SUPERIORITY|||||||0.17||||||No adjustment for multiple comparisons|Wilcoxon (Mann-Whitney)|||Comparison of PSI Parent-Child Dysfunctional Interaction between Week 18 scores, 1 sided test for Treatment Group Superiority||||0.17
72588335|NCT02088905|144707560|SUPERIORITY|||||||0.308||||||No adjustment for multiple comparisons.|t-test, 1 sided|||Comparison of PSI Difficult Child between Week 18 scores, 1 sided test for Treatment Group Superiority||||0.308
72588336|NCT02088905|144707560|SUPERIORITY|||||||0.413||||||No adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||Comparison of PSI Total Score between Week 18 scores, 1 sided test for Treatment Group Superiority||||.413
72414075|NCT01458574|144337123|SUPERIORITY_OR_OTHER||Difference in percentage|11.1|||<|0.0001|TWO_SIDED|95.0|5.9|16.4|||CMH chi-square test|||P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||16.4|5.9|<0.0001
72588337|NCT02088905|144707562|SUPERIORITY|||||||0.271||||||No adjustment for multiple comparisons.|t-test, 1 sided|||Comparison of SRS Total Score between Week 18 scores, 1 sided test for Treatment Group Superiority||||0.271
72588338|NCT02088905|144707562|SUPERIORITY|||||||0.434||||||No adjustment for multiple comparisons.|t-test, 1 sided|||Comparison of SRS Awareness Score between Week 18 scores, 1 sided test for Treatment Group Superiority||||.434
72588339|NCT02088905|144707562|SUPERIORITY|||||||0.298||||||No adjustment for multiple comparisons.|t-test, 1 sided|||Comparison of SRS Cognition Scores between Week 18 scores, 1 sided test for Treatment Group Superiority||||.298
72588340|NCT02088905|144707562|SUPERIORITY|||||||0.294||||||No adjustment for multiple comparisons.|t-test, 1 sided|||Comparison of SRS Communication Score between Week 18 scores, 1 sided test for Treatment Group Superiority||||.294
72588341|NCT02088905|144707562|SUPERIORITY|||||||0.441||||||No adjustment for multiple comparisons.|t-test, 1 sided|||Comparison of SRS Motivation between Week 18 scores, 1 sided test for Treatment Group Superiority||||.441
72588342|NCT02088905|144707562|SUPERIORITY|||||||0.204||||||No adjustment for multiple comparisons.|t-test, 1 sided|||Comparison of SRS Restricted and Repetitive Behavior Score between Week 18 scores, 1 sided test for Treatment Group Superiority||||.204
72588343|NCT02088905|144707564|SUPERIORITY||||||<|0.001||||||No adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||Comparison of DPICS Negative Skills between Week 18 scores, 1 sided test for Treatment Group Superiority||||<.001
72588344|NCT02088905|144707564|SUPERIORITY||||||<|0.001||||||No adjustment for multiple comparisons.|t-test, 1 sided|||Comparison of DPICS Positive Skills between Week 18 scores, 1 sided test for Treatment Group Superiority. Data transformed using a square root transformation.||||<.001
72588345|NCT00379080|144707584|OTHER|||||||0.04|||||||Regression, Cox|||VEGFR2||||0.04
72588346|NCT00379080|144707584|OTHER|||||||0.04|||||||Regression, Cox|||PIGF||||0.04
72588347|NCT00379080|144707584|OTHER|||||||0.02|||||||Regression, Cox|||CAIX||||0.02
72588348|NCT00379080|144707584|OTHER|||||||0.05|||||||Regression, Cox|||sFLT\_1||||0.05
72414076|NCT01458574|144337123|SUPERIORITY_OR_OTHER||Difference in percentage|13.2|||<|0.0001|TWO_SIDED|95.0|7.7|18.7|||CMH chi-square test|||P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||18.7|7.7|<0.0001
72588349|NCT00379080|144707584|OTHER|||||||0.01|||||||Regression, Cox|||sFLT\_1||||0.01
72588350|NCT00379080|144707584|OTHER|||||||0.05|||||||Regression, Cox|||VEGFR2||||0.05
72588351|NCT02901067|144707586|SUPERIORITY|This is a secondary outcome thus no power analysis was done.|||||>|0.05|||||||Fisher Exact|||We hypothesized that the experimental group would present less fibrinolysis shutdown than the control group in all times measured.||||>0.05
72588352|NCT02901067|144707591|SUPERIORITY||||||>|0.05|||||||Fisher Exact|||||||>0.05
72588353|NCT02901067|144707594|SUPERIORITY|||||||0.1|||||||Fisher Exact|||We hypothesized that the experimental group would have less pulmonary embolism events than the control group.||||0.10
72588354|NCT02901067|144707595|SUPERIORITY|||||||0.046|||||||Fisher Exact|||We hypothesized that the experimental group would have a lower incidence of venous thromboembolism (VTE) than the control group.||||0.046
72588355|NCT01222520|144707632|SUPERIORITY_OR_OTHER||Least square mean difference|9.14|||<|0.0001||95.0|7.09|11.18|||ANCOVA|||||11.18|7.09|<0.0001
72588356|NCT01222520|144707633|SUPERIORITY_OR_OTHER||Least square mean difference|14.88|||<|0.0001||95.0|11.82|17.94|||ANCOVA|||||17.94|11.82|<0.0001
72588357|NCT01222520|144707634|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Fisher Exact|||||||<0.0001
72588358|NCT01222520|144707635|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Fisher Exact|||||||<0.0001
72588359|NCT01222520|144707636|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Fisher Exact|||||||<0.0001
72588360|NCT01222520|144707637|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Fisher Exact|||||||<0.0001
72588361|NCT01222520|144707638|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
72588362|NCT01089608|144707667|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-8.01||||0.072|TWO_SIDED|95.0|-16.3|0.28|||Mixed Models Analysis|||||0.28|-16.30|0.072
72588363|NCT00497289|144707689|SUPERIORITY|||||||0.3654|||||||Wilcoxon (Mann-Whitney)|||||||0.3654
72588364|NCT00497289|144707690|SUPERIORITY|||||||0.0264|||||||Wilcoxon (Mann-Whitney)|||||||0.0264
72588365|NCT00955955|144707695|SUPERIORITY_OR_OTHER||Mean Score Reduction|-5.6|STANDARD_DEVIATION|5.7||0.05||95.0|||||SPCD|Sequential Parallel Comparison Design (SPCD)|These results reflect the mean score reduction for the pooled Deplin sample.|Hypothesis 1: There will be a statistically significant difference between the two groups in the degree of improvement, as measured by the change in the 17-item Hamilton Depression Rating Scale (HAM-D-17) score from baseline to endpoint, using the sequential parallel comparison design \[51\]; with a greater degree of reduction in HAM-D-17 scores in the 6(S)-5-MTHF 15 mg qd group than in the placebo group, with the change on placebo being estimated from Trials 1 and 2.||||.05
72414077|NCT01458574|144337124|SUPERIORITY_OR_OTHER||Difference in percentage|12.1|||<|0.0001|TWO_SIDED|95.0|6.3|17.9|||CMH chi-square test|||At Week 24: P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||17.9|6.3|<0.0001
72588366|NCT03852264|144707697|OTHER|90% credible interval for contrast between conditions|Mean Difference (Net)|2.61|||||TWO_SIDED|90.0|-1.29|6.38|||||Contrast reflecting Pet Dog Interaction - Toys Interaction|Bayesian multilevel model of area under the curve with respect to initial value (AUCi) as a function of experimental condition.||6.38|-1.29|
72588367|NCT03852264|144707697|OTHER|90% credible interval for contrast between conditions|Mean Difference (Net)|1.62|||||TWO_SIDED|90.0|-2.18|5.45|||||Contrast reflecting Unfamiliar Dog Interaction - Toys Interaction|Bayesian multilevel model of area under the curve with respect to initial value (AUCi) as a function of experimental condition.||5.45|-2.18|
72588368|NCT03852264|144707697|OTHER|90% credible interval for contrast between conditions|Mean Difference (Net)|-1.0|||||TWO_SIDED|90.0|-4.93|2.83|||||Contrast reflecting Unfamiliar Dog Interaction - Pet Dog Interaction|Bayesian multilevel model of area under the curve with respect to initial value (AUCi) as a function of experimental condition.||2.83|-4.93|
72588369|NCT03852264|144707698|OTHER|90% credible interval for contrast between conditions|Mean Difference (Net)|0.3482|||||TWO_SIDED|90.0|-0.476|1.211|||||Contrast reflecting Pet Dog Interaction - Toys Interaction|Bayesian multilevel model of area under the curve with respect to initial value (AUCi) as a function of experimental condition.||1.211|-0.476|
72588370|NCT03852264|144707698|OTHER|90% credible interval for contrast between conditions|Mean Difference (Net)|-0.0635|||||TWO_SIDED|90.0|-0.931|0.803|||||Contrast reflecting Unfamiliar Dog Interaction - Toys Interaction|Bayesian multilevel model of area under the curve with respect to initial value (AUCi) as a function of experimental condition.||0.803|-0.931|
72588371|NCT03852264|144707698|OTHER|90% credible interval for contrast between conditions|Mean Difference (Net)|-0.422|||||TWO_SIDED|90.0|-1.319|0.445|||||Contrast reflecting Unfamiliar Dog Interaction - Pet Dog Interaction|Bayesian multilevel model of area under the curve with respect to initial value (AUCi) as a function of experimental condition.||0.445|-1.319|
72588372|NCT03852264|144707699|OTHER|90% credible interval for contrast between conditions|Mean Difference (Net)|0.468|||||TWO_SIDED|90.0|-101.0|99.5|||||Contrast reflecting Pet Dog Interaction - Toys Interaction|Bayesian multilevel model of area under the curve with respect to initial value (AUCi) as a function of experimental condition.||99.5|-101|
72588373|NCT03852264|144707699|OTHER|90% credible interval for contrast between conditions|Mean Difference (Net)|-115.0|||||TWO_SIDED|90.0|-225.0|-15.5|||||Contrast reflecting Unfamiliar Dog Interaction - Toys Interaction|Bayesian multilevel model of area under the curve with respect to initial value (AUCi) as a function of experimental condition.||-15.5|-225|
72588374|NCT03852264|144707699|OTHER|90% credible interval for contrast between conditions|Mean Difference (Net)|-115.48|||||TWO_SIDED|90.0|-223.0|-16.2|||||Contrast reflecting Unfamiliar Dog Interaction - Pet Dog Interaction|Bayesian multilevel model of area under the curve with respect to initial value (AUCi) as a function of experimental condition.||-16.2|-223|
72588375|NCT03169881|144707701|SUPERIORITY||Mean Difference (Final Values)|-0.23||||0.88|TWO_SIDED|95.0|-3.09|2.64||The mean difference in Bayley-III cognitive scores between treatment groups was adjusted for center, gestational age group, and familial clustering.|Mixed Models Analysis||Adjusted mean difference in cognitive score for the Darbepoetin minus Placebo treatment groups.|Null hypothesis: Weekly administration of Darbepoetin during the neonatal period will not impact neurocognitive outcomes at 22-26 months compared to Placebo in premature infants 23 to 28 weeks gestation.||2.64|-3.09|0.88
72588376|NCT01028014|144707720|SUPERIORITY_OR_OTHER||||||>|0.05||||||P values comparing differences across groups, as well as within group changes, were all \>0.05.P-values were not adjusted for multiple testing; p\<0.05 was considered statistically significant.|Wilcoxon (Mann-Whitney)|||Using difference in EMG amplitude as primary outcome, assuming standard deviation of 6, we had greater than 80% power to detect a 10-microvolt change in urethral muscle activity with sample size of 9 participants per group. Due to non-normality and small sample sizes, non-parametric tests were used and data presented as median (IQR). Kruskal-Wallis p-values are reported to compare median scores across groups. Wilcoxon sign-test p-values are reported to evaluate 2-week change within groups.||||>0.05
72414078|NCT01458574|144337124|SUPERIORITY_OR_OTHER||Difference in percentage|8.1||||0.0021|TWO_SIDED|95.0|2.8|13.5|||CMH chi-square test|||At Week 24: P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||13.5|2.8|0.0021
72588377|NCT01028014|144707721|SUPERIORITY_OR_OTHER||||||>|0.05||||||P values comparing differences across groups, as well as within group changes, were all \>0.05.P-values were not adjusted for multiple testing; p\<0.05 was considered statistically significant.|Wilcoxon (Mann-Whitney)|||Using difference in EMG amplitude as primary outcome, assuming standard deviation of 6, we had greater than 80% power to detect a 10-microvolt change in urethral muscle activity with sample size of 9 participants per group. Due to non-normality and small sample sizes, non-parametric tests were used and data presented as median (IQR). Kruskal-Wallis p-values are reported to compare median scores across groups. Wilcoxon sign-test p-values are reported to evaluate 2-week change within groups.||||>0.05
72588378|NCT02217410|144707729|OTHER||Mean Difference (Final Values)|0.095||||0.8976|TWO_SIDED|95.0|-0.067|0.263|||Bayesian posterior probability|Posterior probability that the composite efficacy failure difference between CFZ533 and Tac is \< 20%.|Month 3|||0.263|-0.067|0.8976
72588379|NCT02217410|144707729|OTHER||Mean Difference (Final Values)|0.093||||0.8836|TWO_SIDED|95.0|-0.084|0.271|||Bayesian posterior probability|Posterior probability that the composite efficacy failure difference between CFZ533 and Tac is \< 20%.|Month 6|||0.271|-0.084|0.8836
72588380|NCT02217410|144707729|OTHER||Mean Difference (Final Values)|0.093||||0.8822|TWO_SIDED|95.0|-0.085|0.272|||Bayesian posterior probability|Posterior probability that the composite efficacy failure difference between CFZ533 and Tac is \< 20%.|Month 9|||0.272|-0.085|0.8822
72588381|NCT02217410|144707729|OTHER||Mean Difference (Final Values)|0.093||||0.8821|TWO_SIDED|95.0|-0.087|0.273|||Bayesian posterior probability|Posterior probability that the composite efficacy failure difference between CFZ533 and Tac is \< 20%.|Month 12|||0.273|-0.087|0.8821
72588382|NCT00637000|144707738|SUPERIORITY_OR_OTHER||||||<|0.0001||||||The p-value was not adjusted for multiple comparisons.|Repeated measures model|The statistical method used was a group by time repeated measures model with a first-order autoregressive covariance structure||To test the primary study hypothesis that neither soluble film formulation would precipitate an opioid withdrawal syndrome, peak COWS score in the 23.5 hour period after the initial soluble film administration were compared to pre-administration baseline COWS scores (30 minutes prior to soluble film administration) using a group by time repeated measures model with a first-order autoregressive covariance structure.||||<0.0001
72588383|NCT00637000|144707739|SUPERIORITY_OR_OTHER|||||||0|||||||Repeated measures model|Group by time repeated measures model with a first-order autoregressive covariance structure.||||||0.000
72588384|NCT00637000|144707740|SUPERIORITY_OR_OTHER|||||||0.035||||||The p-value was not adjusted for multiple comparisons.|Repeated measures model|Group by time repeated measures model with a first-order autoregressive covariance structure.||||||0.035
72588385|NCT00637000|144707741|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Repeated measures model|Group by time repeated measures model with a first-order autoregressive covariance structure.||||||<0.0001
72588386|NCT00637000|144707742|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Repeated measures model|Group by time repeated measures model with a first-order autoregressive covariance structure.||||||<0.0001
72588387|NCT00637000|144707743|SUPERIORITY_OR_OTHER|||||||0.006||||||The p-value was not adjusted for multiple comparisons.|Repeated measures model|Group by time repeated measures model with a first-order autoregressive covariance structure.||||||0.006
72588388|NCT00637000|144707744|SUPERIORITY_OR_OTHER||||||<|0.0001||||||The p-value was not adjusted for multiple comparisons.|Repeated measures model|Group by time repeated measures model with a first-order autoregressive covariance structure.||||||<0.0001
72414079|NCT01458574|144337124|SUPERIORITY_OR_OTHER||Difference in percentage|10.6||||0.0004|TWO_SIDED|95.0|5.0|16.2|||CMH chi-square test|||At Week 52: P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||16.2|5.0|0.0004
72414080|NCT01458574|144337124|SUPERIORITY_OR_OTHER||Difference in percentage|12.7|||<|0.0001|TWO_SIDED|95.0|6.8|18.6|||CMH chi-square test|||At Week 52: P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||18.6|6.8|<0.0001
72414081|NCT01458574|144337125|SUPERIORITY_OR_OTHER||Difference in percentage|5.6||||0.0029|TWO_SIDED|95.0|2.1|9.0|||CMH chi-square test|||P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||9.0|2.1|0.0029
72414082|NCT01458574|144337125|SUPERIORITY_OR_OTHER||Difference in percentage|4.6||||0.0064|TWO_SIDED|95.0|1.4|7.8|||CMH chi-square test|||P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||7.8|1.4|0.0064
72588389|NCT00637000|144707745|SUPERIORITY_OR_OTHER||||||<|0.0001||||||The p-value was not adjusted for multiple comparisons.|Repeated measures model|Group by time repeated measures model with a first-order autoregressive covariance structure.||||||<0.0001
72588390|NCT00637000|144707746|SUPERIORITY_OR_OTHER|||||||0.762||||||The p-value was not adjusted for multiple comparisons.|Repeated measures model|Group by time repeated measures model with a first-order autoregressive covariance structure.||||||0.762
72588391|NCT00637000|144707747|SUPERIORITY_OR_OTHER||||||<|0.0001||||||The p-value was not adjusted for multiple comparisons.|Repeated measures model|Group by time repeated measures model with a first-order autoregressive covariance structure.||||||<0.0001
72588392|NCT00637000|144707748|SUPERIORITY_OR_OTHER|||||||0.349||||||The p-value is not adjusted for multiple comparisons.|Repeated measures model|Group by time repeated measures model with a first-order autoregressive covariance structure.||||||0.349
72588393|NCT00637000|144707749|SUPERIORITY_OR_OTHER|||||||0.028||||||The p-value was not adjusted for multiple comparisons.|Repeated measures model|Group by time repeated measures model with a first-order autoregressive covariance structure.||||||0.028
72588394|NCT00637000|144707750|SUPERIORITY_OR_OTHER||||||<|0.0001||||||The p-value was not adjusted for multiple comparisons.|Repeated measures model|Group by time repeated measures model with a first-order autoregressive covariance structure.||||||<0.0001
72588395|NCT00637000|144707751|SUPERIORITY_OR_OTHER||||||<|0.0001||||||The p-value was not adjusted for multiple comparisons.|Repeated measures model|Group by time repeated measures model with a first-order autoregressive covariance structure.||||||<0.0001
72588396|NCT00637000|144707752|SUPERIORITY_OR_OTHER|||||||0.117||||||The p-value was not adjusted for multiple comparisons.|Repeated measures model|Group by time repeated measures model with a first-order autoregressive covariance structure.||||||0.117
72588397|NCT00637000|144707753|SUPERIORITY_OR_OTHER||||||<|0.0001||||||The p-value was not adjusted for multiple comparisons.|Repeated measures model|Group by time repeated measures model with a first-order autoregressive covariance structure.||||||<0.0001
72588398|NCT00637000|144707754|SUPERIORITY_OR_OTHER|||||||0.238||||||The p-value was not adjusted for multiple comparisons.|Repeated measures model|Group by time repeated measures model with a first-order autoregressive covariance structure.||||||0.238
72588399|NCT04431908|144707761|OTHER|Sensitivity, specificity and accuracy was measured utilizing the true and false positives, as well as the true and false negatives. For a subject to have a true positive, the subject must have had a positive PCR test for COVID-19 as well as scored 0, 1 or 2 correct answers on the smell test. For a subject to have a true negative, the subject must have had a negative PCR test for COVID-19 as well as scored 3, 4 or 5 correct answers on the smell test.|Specificity|89.35|||||TWO_SIDED|||||||||||||
72588400|NCT04431908|144707761|OTHER|Sensitivity, specificity and accuracy was measured utilizing the true and false positives, as well as the true and false negatives. For a subject to have a true positive, the subject must have had a positive PCR test for COVID-19 as well as scored 0, 1 or 2 correct answers on the smell test. For a subject to have a true negative, the subject must have had a negative PCR test for COVID-19 as well as scored 3, 4 or 5 correct answers on the smell test.|Sensitivity|42.55|||||TWO_SIDED|||||||||||||
72588401|NCT04431908|144707761|OTHER|Sensitivity, specificity and accuracy was measured utilizing the true and false positives, as well as the true and false negatives. For a subject to have a true positive, the subject must have had a positive PCR test for COVID-19 as well as scored 0, 1 or 2 correct answers on the smell test. For a subject to have a true negative, the subject must have had a negative PCR test for COVID-19 as well as scored 3, 4 or 5 correct answers on the smell test.|Accuracy|87.24|||||TWO_SIDED|||||||||||||
72414083|NCT01458574|144337127|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-2.6|||<|0.0001|TWO_SIDED|95.0|-3.2|-1.9|||Linear mixed effect model|||At Week 24||-1.9|-3.2|<0.0001
72588402|NCT04431908|144707763|OTHER|Sensitivity, specificity and accuracy was measured utilizing the true and false positives, as well as the true and false negatives. For a subject to have a true positive, the subject must have had a positive PCR test for COVID-19 as well as scored 0, 1 or 2 correct answers on the smell test. For a subject to have a true negative, the subject must have had a negative PCR test for COVID-19 as well as scored 3, 4 or 5 correct answers on the smell test.|Specificity|88.73|||||TWO_SIDED|||||||||||||
72588403|NCT04431908|144707763|OTHER|Sensitivity, specificity and accuracy was measured utilizing the true and false positives, as well as the true and false negatives. For a subject to have a true positive, the subject must have had a positive PCR test for COVID-19 as well as scored 0, 1 or 2 correct answers on the smell test. For a subject to have a true negative, the subject must have had a negative PCR test for COVID-19 as well as scored 3, 4 or 5 correct answers on the smell test.|Sensitivity|33.33|||||TWO_SIDED|||||||||||||
72588404|NCT04431908|144707763|OTHER|Sensitivity, specificity and accuracy was measured utilizing the true and false positives, as well as the true and false negatives. For a subject to have a true positive, the subject must have had a positive PCR test for COVID-19 as well as scored 0, 1 or 2 correct answers on the smell test. For a subject to have a true negative, the subject must have had a negative PCR test for COVID-19 as well as scored 3, 4 or 5 correct answers on the smell test.|Accuracy|88.13|||||TWO_SIDED|||||||||||||
72588405|NCT01218087|144707799|NON_INFERIORITY_OR_EQUIVALENCE|Following the first interim analysis of the first 40 infants, the sample size calculation was revised. A revised sample size of 62 infants (31 per treatment arm) was based on an observed reduction of 41% to 11% in the experimental group with a goal p value of 0.01.||||||0.03|TWO_SIDED||||||Fisher Exact|||||||0.03
72588406|NCT00653133|144707864|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||Null hypothesis: There is no difference in reported complications associated with the placement of continuous peripheral nerve block catheters between ultrasound imaging guided placement and nerve stimulator guided placement.||||<0.05
72588407|NCT05088603|144707870|SUPERIORITY|||||||0.106|||||||Fisher Exact|||||||0.106
72588408|NCT05088603|144707871|SUPERIORITY|||||||0.99|||||||Fisher Exact|||||||0.99
72588409|NCT05088603|144707872|SUPERIORITY|||||||0.99|||||||Fisher Exact|||||||0.99
72588410|NCT05088603|144707874|SUPERIORITY|||||||0.529|||||||Fisher Exact|||||||0.529
72588411|NCT05088603|144707875|SUPERIORITY|||||||0.99|||||||Fisher Exact|||||||0.99
72588412|NCT05088603|144707876|SUPERIORITY|||||||0.502|||||||Fisher Exact|||||||0.502
72588413|NCT05088603|144707877|SUPERIORITY|||||||0.431|||||||Fisher Exact|||||||0.431
72588414|NCT05088603|144707878|SUPERIORITY|||||||0.434|||||||Fisher Exact|||||||0.434
72588415|NCT05088603|144707879|SUPERIORITY|||||||0.159|||||||Fisher Exact|||||||0.159
72588416|NCT05088603|144707880|SUPERIORITY|||||||0.051|||||||Fisher Exact|||||||0.051
72588417|NCT00594100|144707895|SUPERIORITY_OR_OTHER||Binomial Proportion|0.054|STANDARD_ERROR_OF_MEAN|0.016||0.002|TWO_SIDED|95.0|0.027|0.095|||One-Sample Binomial|Significance test was based on a one-sample binomial test|95% Confidence Interval is exact binomial using Clopper-Pearson method. Standard Error is from Normal approximation.|The EMPiRE Study tested the null hypothesis that the true MAE rate was greater than or equal to an Objective Performance Criterion (OPC) of 11.83% versus the alternative hypothesis that the true MAE rate was less than the OPC. The sample size was calculated based on 80% power and a Type I error rate of 0.025. The OPC was calculated from results of published carotid artery stenting studies that utilized distal embolic protection systems.||0.095|0.027|0.002
72588418|NCT01270464|144707901|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.16|STANDARD_ERROR_OF_MEAN|0.0507||0.0018|TWO_SIDED|95.0|0.06|0.259||The overall treatment effect for each reslizumab dose was compared to placebo using a 2-sided t-test at the a priori significance level of 0.05.|Mixed Models Analysis|||The primary variable was analyzed using a mixed-effect model for repeated measures (MMRM) with fixed effects (treatment, stratification factors, sex, visit, interaction of treatment and visit), covariates (height, baseline value), and patient as the random effect for the repeated measurements.||0.259|0.060|0.0018
72588419|NCT01270464|144707901|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.115|STANDARD_ERROR_OF_MEAN|0.0508||0.0237|TWO_SIDED|95.0|0.016|0.215||The overall treatment effect for each reslizumab dose was compared to placebo using a 2-sided t-test at the a priori significance level of 0.05.|Mixed Models Analysis|||The primary variable was analyzed using a mixed-effect model for repeated measures (MMRM) with fixed effects (treatment, stratification factors, sex, visit, interaction of treatment and visit), covariates (height, baseline value), and patient as the random effect for the repeated measurements.||0.215|0.016|0.0237
72588420|NCT01270464|144707902|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.13|STANDARD_ERROR_OF_MEAN|0.0543||0.0174|TWO_SIDED|95.0|0.023|0.237||The overall treatment effect for each reslizumab dose was compared to placebo using a 2-sided t-test at the a priori significance level of 0.05.|Mixed Models Analysis|||As with the primary outcome, this respiratory test outcome was analyzed using a mixed-effect model for repeated measures (MMRM) with fixed effects (treatment, stratification factors, sex, visit, interaction of treatment and visit), covariates (height, baseline value), and patient as the random effect for the repeated measurements.||0.237|0.023|0.0174
72414084|NCT01458574|144337127|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-2.8|||<|0.0001|TWO_SIDED|95.0|-3.5|-2.2|||Linear mixed effect model|||At Week 24||-2.2|-3.5|<0.0001
72414085|NCT01458574|144337127|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-2.6|||<|0.0001|TWO_SIDED|95.0|-3.4|-1.7|||Linear mixed effect model|||At Week 52||-1.7|-3.4|<0.0001
72588421|NCT01270464|144707902|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.048|STANDARD_ERROR_OF_MEAN|0.0543||0.3731|TWO_SIDED|95.0|-0.058|0.155||The overall treatment effect for each reslizumab dose was compared to placebo using a 2-sided t-test at the a priori significance level of 0.05.|Mixed Models Analysis|||As with the primary outcome, this respiratory test outcome was analyzed using a mixed-effect model for repeated measures (MMRM) with fixed effects (treatment, stratification factors, sex, visit, interaction of treatment and visit), covariates (height, baseline value), and patient as the random effect for the repeated measurements.||0.155|-0.058|0.3731
72414086|NCT01458574|144337127|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-3.3|||<|0.0001|TWO_SIDED|95.0|-4.1|-2.5|||Linear mixed effect model|||At Week 52||-2.5|-4.1|<0.0001
72588422|NCT01270464|144707903|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.233|STANDARD_ERROR_OF_MEAN|0.1212||0.0552|TWO_SIDED|95.0|-0.005|0.472||The overall treatment effect for each reslizumab dose was compared to placebo using a 2-sided t-test at the a priori significance level of 0.05.|Mixed Models Analysis|||As with the primary outcome, this respiratory test outcome was analyzed using a mixed-effect model for repeated measures (MMRM) with fixed effects (treatment, stratification factors, sex, visit, interaction of treatment and visit), covariates (height, baseline value), and patient as the random effect for the repeated measurements.||0.472|-0.005|0.0552
72588423|NCT01270464|144707903|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.03|STANDARD_ERROR_OF_MEAN|0.1215||0.802|TWO_SIDED|95.0|-0.209|0.27||The overall treatment effect for each reslizumab dose was compared to placebo using a 2-sided t-test at the a priori significance level of 0.05.|Mixed Models Analysis|||As with the primary outcome, this respiratory test outcome was analyzed using a mixed-effect model for repeated measures (MMRM) with fixed effects (treatment, stratification factors, sex, visit, interaction of treatment and visit), covariates (height, baseline value), and patient as the random effect for the repeated measurements.||0.270|-0.209|0.8020
72588424|NCT01270464|144707905|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.359|STANDARD_ERROR_OF_MEAN|0.111||0.0014|TWO_SIDED|95.0|-0.577|-0.14||The overall treatment effect for each reslizumab dose was compared to placebo using a 2-sided t-test at the a priori significance level of 0.05.|Mixed Models Analysis|||As with the primary outcome, this respiratory test outcome was analyzed using a mixed-effect model for repeated measures (MMRM) with fixed effects (treatment, stratification factors, sex, visit, interaction of treatment and visit), covariates (height, baseline value), and patient as the random effect for the repeated measurements.||-0.140|-0.577|0.0014
72588425|NCT01270464|144707905|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.238|STANDARD_ERROR_OF_MEAN|0.1108||0.0329|TWO_SIDED|95.0|-0.456|-0.019||The overall treatment effect for each reslizumab dose was compared to placebo using a 2-sided t-test at the a priori significance level of 0.05.|Mixed Models Analysis|||As with the primary outcome, this respiratory test outcome was analyzed using a mixed-effect model for repeated measures (MMRM) with fixed effects (treatment, stratification factors, sex, visit, interaction of treatment and visit), covariates (height, baseline value), and patient as the random effect for the repeated measurements.||-0.019|-0.456|0.0329
72588426|NCT01270464|144707906|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.359|STANDARD_ERROR_OF_MEAN|0.1582||0.0241|TWO_SIDED|95.0|0.047|0.67||The overall treatment effect for each reslizumab dose was compared to placebo using a 2-sided t-test at the a priori significance level of 0.05.|Mixed Models Analysis|||As with the primary outcome, this respiratory test outcome was analyzed using a mixed-effect model for repeated measures (MMRM) with fixed effects (treatment, stratification factors, sex, visit, interaction of treatment and visit), covariates (height, baseline value), and patient as the random effect for the repeated measurements.||0.670|0.047|0.0241
72588427|NCT01270464|144707906|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.278|STANDARD_ERROR_OF_MEAN|0.1591||0.0822|TWO_SIDED|95.0|-0.036|0.591||The overall treatment effect for each reslizumab dose was compared to placebo using a 2-sided t-test at the a priori significance level of 0.05.|Mixed Models Analysis|||As with the primary outcome, this respiratory test outcome was analyzed using a mixed-effect model for repeated measures (MMRM) with fixed effects (treatment, stratification factors, sex, visit, interaction of treatment and visit), covariates (height, baseline value), and patient as the random effect for the repeated measurements.||0.591|-0.036|0.0822
72588428|NCT01270464|144707907|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.047|STANDARD_ERROR_OF_MEAN|0.0193||0.016|TWO_SIDED|95.0|0.009|0.085||The overall treatment effect for each reslizumab dose was compared to placebo using a 2-sided t-test at the a priori significance level of 0.05.|Mixed Models Analysis|||As with the primary outcome, this respiratory test outcome was analyzed using a mixed-effect model for repeated measures (MMRM) with fixed effects (treatment, stratification factors, sex, visit, interaction of treatment and visit), covariates (height, baseline value), and patient as the random effect for the repeated measurements.||0.085|0.009|0.0160
72588429|NCT01270464|144707907|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.051|STANDARD_ERROR_OF_MEAN|0.0193||0.0094|TWO_SIDED|95.0|0.012|0.089||The overall treatment effect for each reslizumab dose was compared to placebo using a 2-sided t-test at the a priori significance level of 0.05.|Mixed Models Analysis|||As with the primary outcome, this respiratory test outcome was analyzed using a mixed-effect model for repeated measures (MMRM) with fixed effects (treatment, stratification factors, sex, visit, interaction of treatment and visit), covariates (height, baseline value), and patient as the random effect for the repeated measurements.||0.089|0.012|0.0094
72588430|NCT01270464|144707908|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.624|STANDARD_ERROR_OF_MEAN|0.2551||0.0151|TWO_SIDED|95.0|-1.126|-0.121||The overall treatment effect for each reslizumab dose was compared to placebo using a 2-sided t-test at the a priori significance level of 0.05.|Mixed Models Analysis|||As with the primary outcome, this respiratory test outcome was analyzed using a mixed-effect model for repeated measures (MMRM) with fixed effects (treatment, stratification factors, sex, visit, interaction of treatment and visit), covariates (height, baseline value), and patient as the random effect for the repeated measurements.||-0.121|-1.126|0.0151
72414087|NCT01458574|144337128|SUPERIORITY_OR_OTHER||Difference in percentage|40.1|||<|0.0001|TWO_SIDED|95.0|25.0|55.3|||CMH chi-square test|||At Week 24: P-value based on CMH chi-square test stratified by induction study treatment. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||55.3|25.0|<0.0001
72588431|NCT01270464|144707908|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.648|STANDARD_ERROR_OF_MEAN|0.2559||0.0119|TWO_SIDED|95.0|-1.152|-0.144||The overall treatment effect for each reslizumab dose was compared to placebo using a 2-sided t-test at the a priori significance level of 0.05.|Mixed Models Analysis|||As with the primary outcome, this respiratory test outcome was analyzed using a mixed-effect model for repeated measures (MMRM) with fixed effects (treatment, stratification factors, sex, visit, interaction of treatment and visit), covariates (height, baseline value), and patient as the random effect for the repeated measurements.||-0.144|-1.152|0.0119
72588432|NCT01270464|144707909|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.494|STANDARD_ERROR_OF_MEAN|0.0242||0|TWO_SIDED|95.0|-0.542|-0.447||The overall treatment effect for each reslizumab dose was compared to placebo using a 2-sided t-test at the a priori significance level of 0.05.|Regression, Logistic|||As with the primary outcome, this respiratory test outcome was analyzed using a mixed-effect model for repeated measures (MMRM) with fixed effects (treatment, stratification factors, sex, visit, interaction of treatment and visit), covariates (height, baseline value), and patient as the random effect for the repeated measurements.||-0.447|-0.542|0.0000
72588433|NCT01270464|144707909|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.323|STANDARD_ERROR_OF_MEAN|0.0243||0|TWO_SIDED|95.0|-0.37|-0.275||The overall treatment effect for each reslizumab dose was compared to placebo using a 2-sided t-test at the a priori significance level of 0.05.|Mixed Models Analysis|||As with the primary outcome, this respiratory test outcome was analyzed using a mixed-effect model for repeated measures (MMRM) with fixed effects (treatment, stratification factors, sex, visit, interaction of treatment and visit), covariates (height, baseline value), and patient as the random effect for the repeated measurements.||-0.275|-0.370|0.0000
72588434|NCT02162719|144707940|SUPERIORITY||Hazard Ratio (Stratified Analysis)|0.6||||0.0372|TWO_SIDED|90.0|0.4|0.91||Stratification variables were adjuvant/neoadjuvant treatment including treatment with or without radiation, disease-free interval from last dose (\<=12 vs \>12 months vs. no prior chemotherapy), PTEN status of tumor (H-score 0, vs. 1 to 150, vs. \>150).|Log Rank|||||0.91|0.40|0.0372
72588435|NCT02162719|144707941|SUPERIORITY||Hazard Ratio (Stratified Analysis)|0.59||||0.1753|TWO_SIDED|90.0|0.3|1.16||Stratification variables were adjuvant/neoadjuvant treatment including treatment with or without radiation, disease-free interval from last dose (\<=12 vs \>12 months vs. no prior chemotherapy), PTEN status of tumor (H-score 0, vs. 1 to 150, vs. \>150).|Log Rank|||||1.16|0.30|0.1753
72588436|NCT02162719|144707942|SUPERIORITY||Hazard Ratio (Unstratified Analysis)|0.76||||0.3636|TWO_SIDED|90.0|0.46|1.27|||Log Rank|||||1.27|0.46|0.3636
72588437|NCT02162719|144707943|SUPERIORITY||Hazard Ratio (Stratified Analysis)|0.8||||0.3607|TWO_SIDED|95.0|0.5|1.28||Stratification variables were adjuvant/neoadjuvant treatment including treatment with/without radiation, disease-free interval from last dose (\<=12 vs \>12 months vs. no prior chemotherapy), PTEN status of tumor (H-score 0, vs. 1 to 150, vs. \>150).|Log Rank|||||1.28|0.50|0.3607
72588438|NCT02162719|144707944|SUPERIORITY||Hazard Ratio (Stratified Analysis)|0.73||||0.4422|TWO_SIDED|95.0|0.32|1.65||Stratification variables were adjuvant/neoadjuvant treatment including treatment with/without radiation, disease-free interval from last dose (\<=12 vs \>12 months vs. no prior chemotherapy), PTEN status of tumor (H-score 0, vs. 1 to 150, vs. \>150).|Log Rank|||||1.65|0.32|0.4422
72588439|NCT02162719|144707945|SUPERIORITY||Hazard Ratio (Unstratified Analysis)|1.13||||0.7599|TWO_SIDED|95.0|0.52|2.47|||Log Rank|||||2.47|0.52|0.7599
72588440|NCT01369030|144707960|SUPERIORITY_OR_OTHER||Mean Difference (Net)|8.5|STANDARD_DEVIATION|6.3||0|||||||Wilcoxon signed-rank test|||||||0.000
72588441|NCT05406479|144708028|NON_INFERIORITY|For the hypothesis testing of non-inferiority the confidence interval should be compared to the non-inferiority margin. More specifically, non-inferiority is established if the upper limit of a one-sided 95% confidence interval around the difference in means QTc 24 hours after treatment administration (BE-PEP - SDR-PEP) is below the non-inferiority limit of +10 ms. A two-sample t-test was used to compare the two groups, but the p-value returned should not be used to conclude non-inferiority.|Mean Difference (Final Values)|-0.193|||||TWO_SIDED|95.0|-5.146|4.76||||||Adults||4.76|-5.146|
72588442|NCT05406479|144708028|NON_INFERIORITY|For the hypothesis testing of non-inferiority the confidence interval should be compared to the non-inferiority margin. More specifically, non-inferiority is established if the upper limit of a one-sided 95% confidence interval around the difference in means QTc 24 hours after treatment administration (BE-PEP - SDR-PEP) is below the non-inferiority limit of +10 ms. A two-sample t-test was used to compare the two groups, but the p-value returned should not be used to conclude non-inferiority.|Mean Difference (Final Values)|10.556|||||TWO_SIDED|95.0|0.926|20.185||||||Adolescents (13-17)||20.185|0.926|
72588443|NCT05406479|144708028|NON_INFERIORITY|For the hypothesis testing of non-inferiority the confidence interval should be compared to the non-inferiority margin. More specifically, non-inferiority is established if the upper limit of a one-sided 95% confidence interval around the difference in means QTc 24 hours after treatment administration (BE-PEP - SDR-PEP) is below the non-inferiority limit of +10 ms. A two-sample t-test was used to compare the two groups, but the p-value returned should not be used to conclude non-inferiority.|Mean Difference (Final Values)|2.076|||||TWO_SIDED|95.0|-3.374|7.525||||||Children (5-12)||7.525|-3.374|
72588444|NCT01931475|144708055|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5|||||TWO_SIDED|95.0|-0.8|-0.2||||||||-0.2|-0.80|
72588445|NCT01931475|144708056|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.36|||||TWO_SIDED|95.0|-0.54|-0.19||||||||-0.19|-0.54|
72588446|NCT01931475|144708057|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.49|||||TWO_SIDED|95.0|-5.62|-1.35|||||Total Score|||-1.35|-5.62|
72588447|NCT01931475|144708057|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.71|||||TWO_SIDED|95.0|-1.21|-0.21|||||Pain|||-0.21|-1.21|
72588448|NCT01931475|144708057|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.36|||||TWO_SIDED|95.0|-3.95|-0.78|||||Physical Function|||-0.78|-3.95|
72588449|NCT01931475|144708057|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.39|||||TWO_SIDED|95.0|-0.62|-0.16|||||Stiffness|||-0.16|-0.62|
72588450|NCT01931475|144708058|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.28|||||TWO_SIDED|95.0|-0.41|-0.15||||||||-0.15|-0.41|
72588451|NCT01931475|144708059|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.71|||||TWO_SIDED|95.0|-1.07|-0.34|||||BPI Severity of Worst Pain|||-0.34|-1.07|
72588452|NCT01931475|144708059|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.29|||||TWO_SIDED|95.0|-0.6|0.03|||||BPI Severity of Least Pain|||0.03|-0.60|
72588453|NCT01931475|144708059|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.47|||||TWO_SIDED|95.0|-0.82|-0.11|||||BPI Severity of Right Now Pain|||-0.11|-0.82|
72588454|NCT01931475|144708060|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.27|||||TWO_SIDED|95.0|-0.53|-0.02|||||BPI Interference Average Score|||-0.02|-0.53|
72588455|NCT01931475|144708060|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.56|||||TWO_SIDED|95.0|-0.94|-0.19|||||General activity|||-0.19|-0.94|
72588456|NCT01931475|144708060|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.39|||||TWO_SIDED|95.0|-0.74|-0.05|||||Mood|||-0.05|-0.74|
72588457|NCT01931475|144708060|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.47|||||TWO_SIDED|95.0|-0.82|-0.11|||||Walking ability|||-0.11|-0.82|
72588458|NCT01931475|144708060|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.31|||||TWO_SIDED|95.0|-0.68|0.06|||||Normal work (includes both work outside the home and housework)|||0.06|-0.68|
72588459|NCT01931475|144708060|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.07|||||TWO_SIDED|95.0|-0.34|0.21|||||Relations with other people|||0.21|-0.34|
72588460|NCT01931475|144708060|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.22|||||TWO_SIDED|95.0|-0.57|0.14|||||Sleep|||0.14|-0.57|
72588461|NCT01931475|144708060|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.06|||||TWO_SIDED|95.0|-0.4|0.27|||||Enjoyment of life|||0.27|-0.40|
72588462|NCT01931475|144708062|SUPERIORITY_OR_OTHER||Total Effect|97.49||||0.002|TWO_SIDED||||||Regression, Linear|||Path analysis for the direct analgesic effect was used to test the null hypothesis that the change in BPI average pain severity depends on the improvement of HADS-D or HADS-A, versus the alternative that the improvement in BPI average pain severity is due to a direct analgesic effect of the treatment and not dependent upon the improvement in depression and anxiety symptoms.||||0.002
72588463|NCT06175026|144708065|SUPERIORITY||Mean Difference (Final Values)|1.25|STANDARD_ERROR_OF_MEAN|0.062|<|0.001|TWO_SIDED|95.0|1.13|1.37||The p-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|||The null hypothesis was that the health messages would not elicit different levels of perceived message effectiveness compared to the neutral messages.||1.37|1.13|<0.001
72588464|NCT06175026|144708065|SUPERIORITY||Mean Difference (Final Values)|1.14|STANDARD_ERROR_OF_MEAN|0.062|<|0.001|TWO_SIDED|95.0|1.03|1.26||The p-value was not adjusted for multiple comparisons. The a prior threshold for statistical significance was 0.05.|Mixed Models Analysis|||The null hypothesis was that the environment messages would not elicit different perceived message effectiveness than the control messages.||1.26|1.03|<.001
72588465|NCT06175026|144708065|SUPERIORITY||Mean Difference (Final Values)|1.29|STANDARD_ERROR_OF_MEAN|0.062|<|0.001|TWO_SIDED|95.0|1.17|1.41||The p-value was not adjusted for multiple comparisons. The a prior threshold for statistical significance was 0.05.|Mixed Models Analysis|||The null hypothesis was that the health and environment messages would not elicit different perceived message effectiveness than the control messages.||1.41|1.17|<0.001
72588466|NCT06175026|144708065|SUPERIORITY||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.062||0.1892|TWO_SIDED|95.0|-0.018|0.223||This p-value was adjusted for multiple comparisons (considering 3 tests among intervention arms) using the Bonferroni Holm method.|Mixed Models Analysis|||||.223|-0.018|.1892
72588467|NCT06175026|144708065|SUPERIORITY||Mean Difference (Final Values)|-0.045|STANDARD_ERROR_OF_MEAN|0.62||0.47|TWO_SIDED|95.0|-0.17|0.08||This p-value was adjusted for multiple comparisons (considering 3 tests among intervention arms) using the Bonferroni Holm method.|Mixed Models Analysis|||||.08|-.17|.47
72588468|NCT06175026|144708065|SUPERIORITY||Mean Difference (Final Values)|-0.15|STANDARD_ERROR_OF_MEAN|0.062||0.051|TWO_SIDED|95.0|-0.27|-0.03||This p-value was adjusted for multiple comparisons (considering 3 tests among intervention arms) using the Bonferroni Holm method.|Mixed Models Analysis|||||-.03|-.27|.051
72588469|NCT04081610|144708066|NON_INFERIORITY|Compare the safety of the Lagricel® Ofteno multi-dose formulation against Lagricel® Ofteno unit doses manufactured by Sophia Laboratories S.A. of C.V. through the incidence of AD.|Median Difference (Final Values)|0.05||||0.409|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.409
72588470|NCT04081610|144708067|NON_INFERIORITY|Compare the tolerability of the Lagricel® Ofteno multi-dose formulation against Lagricel® Ofteno unit-dose manufactured by Sophia Laboratories S.A. of C.V. using the ICO score.||||||0.442|||||||Wilcoxon (Mann-Whitney)|||||||0.442
72588471|NCT04081610|144708067|EQUIVALENCE|F=2.606, 15.926||||||0.009|||||||Wilcoxon (Mann-Whitney)|||Final vs initial Eye Comfort Index||||0.009
72588472|NCT04081610|144708067|EQUIVALENCE|F=3.051, 19.336||||||0.002|||||||Wilcoxon (Mann-Whitney)|||Final vs initial Eye Comfort Index||||0.002
72588473|NCT04081610|144708068|NON_INFERIORITY|Compare the safety of the Lagricel® Ofteno multi-dose formulation against Lagricel® Ofteno unit doses manufactured by Sophia Laboratories S.A. of C.V. through changes in BCVA.||||||0.904|||||||Wilcoxon (Mann-Whitney)|||||||0.904
72588474|NCT04081610|144708068|EQUIVALENCE|F=-1.414, 1.061||||||0.157|||||||Sign test|||Final vs initial VA||||0.157
72588475|NCT04081610|144708068|EQUIVALENCE|||||||1|||||||Sign test|||Final vs initial VA||||1.000
72588476|NCT04081610|144708069|NON_INFERIORITY|Compare the safety of the Lagricel® Ofteno multi-dose formulation against Lagricel® Ofteno unit doses manufactured by Sophia Laboratories S.A. of C.V. by changes in corneal and conjunctival staining with fluorescein.||||||1|||||||Fisher Exact|||||||1.000
72588477|NCT04081610|144708069|EQUIVALENCE|Chi-squared (2)= 6.400||||||0.041|||||||Chi-squared|||Final vs initial fluorescein staining||||0.041
72588478|NCT04081610|144708069|EQUIVALENCE|Chi-squared (2)=0.814||||||0.665|||||||Chi-squared|||||||0.665
72588479|NCT04081610|144708070|NON_INFERIORITY|Compare the safety of the Lagricel® Ofteno multi-dose formulation against Lagricel® Ofteno unit doses manufactured by Sophia Laboratories S.A. of C.V. by changes of corneal and conjunctival staining with lysamine green.||||||0.713|||||||Fisher Exact|||||||0.713
72588480|NCT04081610|144708070|EQUIVALENCE|Chi-squared (3)=14.345||||||0.002|||||||Chi-squared|||Final vs initial lissamine green staining||||0.002
72588481|NCT04081610|144708070|EQUIVALENCE|Chi-squared (2)=0.506||||||0.777|||||||Chi-squared|||Final vs initial lissamine green staining||||0.777
72588482|NCT04081610|144708071|NON_INFERIORITY|Compare the safety of the Lagricel® Ofteno multi-dose formulation against Lagricel® Ofteno unit doses manufactured by Sophia Laboratories S.A. of C.V. by changes in conjunctival hyperemia.||||||1|||||||Chi-squared, Corrected|||||||1.000
72588483|NCT04081610|144708071|EQUIVALENCE|F=4.167, 1||||||0.031|||||||Fisher Exact|||Final vs initial conjunctival hyperemia||||0.031
72588484|NCT04081610|144708071|EQUIVALENCE|No significant change was observed.||||||1|||||||Chi-squared, Corrected|||Final vs initial conjunctival hyperemia||||1.000
72588485|NCT02920008|144708079|SUPERIORITY||||||=|0.3287|||||||Stratified log-rank|||||||= 0.3287
72588486|NCT00930774|144708116|SUPERIORITY_OR_OTHER|||||||0.527|||||||ANOVA|df = 3,83; F=0.748||||||0.527
72588487|NCT00930774|144708117|SUPERIORITY_OR_OTHER|||||||0.835|||||||ANOVA|df = 3,83; F=0.286||||||0.835
72588488|NCT00930774|144708118|SUPERIORITY_OR_OTHER|||||||0.983|||||||ANOVA|df = 3,83; F=0.054||||||0.983
72588489|NCT00930774|144708119|SUPERIORITY_OR_OTHER|||||||0.554||||||df = 3,83; F=0.701|ANOVA|||||||0.554
72588490|NCT00930774|144708120|SUPERIORITY_OR_OTHER|||||||0.757||||||df = 3,83; F=0.395|ANOVA|||||||0.757
72588491|NCT00930774|144708121|SUPERIORITY_OR_OTHER|||||||0.302|||||||ANOVA|df = 3,83; F=1.236||||||0.302
72588492|NCT00930774|144708122|SUPERIORITY_OR_OTHER|||||||0.001|||||||ANOVA|df = 3,83. F=6.343||||||0.001
72588493|NCT00930774|144708122|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
72588494|NCT00930774|144708123|SUPERIORITY_OR_OTHER|||||||0.013|||||||ANOVA|df = 3,83; F=3.797||||||0.013
72588495|NCT00930774|144708123|SUPERIORITY_OR_OTHER|||||||0.05|||||||ANOVA|||||||0.05
72588496|NCT03200704|144708124|NON_INFERIORITY|90% power, 2.5% one-sided significance level,5% non-inferiority margin|||||<|0.0001|||||||Regression, Logistic|||"Hypothesis:~H0: QT ≤ QC - 0.05 H1: QT \> QC - 0.05"||||<0.0001
72588497|NCT00839527|144708128|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.87|||<|0.0001|TWO_SIDED|95.0|-1.07|-0.68|||ANCOVA|||||-0.68|-1.07|<0.0001
72588498|NCT00839527|144708128|NON_INFERIORITY_OR_EQUIVALENCE|The p-value is from a one-sided t-test testing at the 0.025 level of significance whether or not the difference of least square means (albiglutide - pioglitazone) is less than or equal to the pre-specified non-inferiority margin of 0.3%.|Mean Difference (Net)|0.25||||0.2685|TWO_SIDED|95.0|0.1|0.4|||t-test, 1 sided|||||0.40|0.10|0.2685
72588499|NCT01704651|144708137|SUPERIORITY_OR_OTHER|||||||0.34|||||||t-test, 2 sided|||||||0.34
72588500|NCT01704651|144708138|SUPERIORITY_OR_OTHER|||||||0.17|||||||t-test, 2 sided|||||||0.17
72588501|NCT00778869|144708142|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Student t-test|||||||<0.05
72588502|NCT02282631|144708176|SUPERIORITY_OR_OTHER|||||||0.02|||||||Wilcoxon (Mann-Whitney)|"U=390.5 Z=-2.3 p=0.02~The mean and SD values are provided for descriptive purposes only."||||||0.02
72588503|NCT02282631|144708177|SUPERIORITY_OR_OTHER|||||||0.02||||||"U=665.5 Z=-2.3 p=0.02~The mean and SD values are provided for descriptive purposes only."|Wilcoxon (Mann-Whitney)|||||||0.02
72588504|NCT02282631|144708178|SUPERIORITY_OR_OTHER|||||||0.02||||||"U=596.5 Z=-2.4 p=0.02~The mean and SD values are provided for descriptive purposes only."|Wilcoxon (Mann-Whitney)|||||||0.02
72588505|NCT02282631|144708179|SUPERIORITY_OR_OTHER|||||||0.01||||||"U=955.0 Z=-2.5 p=0.01~The mean and SD values are provided for descriptive purposes only."|Wilcoxon (Mann-Whitney)|||||||0.01
72588506|NCT04075682|144708193|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus their not being equal.|Mean Difference (Net)|0.26|STANDARD_ERROR_OF_MEAN|0.51||0.6|TWO_SIDED|95.0|-0.73|1.25||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects ordinal regression models that accounted for repeated measures at both the day- and individual-levels.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the pre-specified H1 assessment (see Statistical Analysis Plan, Model 1), comparing groups that received inserts (insert only AND insert + pictorial warnings) with the groups that did not (pictorial warning only AND control). We expected that the outcome would be higher in the insert groups than in the no insert groups.||1.25|-0.73|0.60
72414088|NCT01458574|144337128|SUPERIORITY_OR_OTHER||Difference in percentage|48.4|||<|0.0001|TWO_SIDED|95.0|32.7|64.1|||CMH chi-square test|||At Week 24: P-value based on CMH chi-square test stratified by induction study treatment. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||64.1|32.7|<0.0001
72414089|NCT01458574|144337128|SUPERIORITY_OR_OTHER||Difference in percentage|36.0|||<|0.0001|TWO_SIDED|95.0|21.6|50.3|||CMH chi-square test|||At Week 52: P-value based on CMH chi-square test stratified by induction study treatment. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||50.3|21.6|<0.0001
72588507|NCT04075682|144708193|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus their not being equal.|Mean Difference (Net)|-0.78|STANDARD_ERROR_OF_MEAN|0.73||0.29|TWO_SIDED|95.0|-2.22|0.66||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects ordinal regression models that accounted for repeated measures at both the day- and individual-levels.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the pre-specified H3 assessment (see Statistical Analysis Plan, Model 1), comparing the group that received inserts and pictorial warnings with the group that received inserts only. We expected that this outcome would be higher in the insert and pictorial warning group than in the insert only group.||0.66|-2.22|0.29
72588508|NCT04075682|144708193|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|-0.25|STANDARD_ERROR_OF_MEAN|0.72||0.73|TWO_SIDED|95.0|-1.67|1.16||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordinal regression models that accounted for repeated measures at both the day- and individual-levels.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the pre-specified H4 assessment (see Statistical Analysis Plan, Model 1), comparing the group that received inserts and pictorial warnings with the group that received pictorial warnings only. We expected that this outcome would be higher in the insert and pictorial warning group than in the pictorial warning only group.||1.16|-1.67|0.73
72588509|NCT04075682|144708193|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|-0.3|STANDARD_ERROR_OF_MEAN|1.04||0.77|TWO_SIDED|95.0|-2.34|1.74||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordinal regression models that accounted for repeated measures at both the day- and individual-levels.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6a assessment, which evaluates moderation of the pre-specified H1 assessment. We expected that the effect of inserts (averaged over pictorial warnings) compared to no inserts (averaged over pictorial warnings) on the outcome would be stronger for those with higher than lower education (see Statistical Analysis Plan, Model 5).||1.74|-2.34|0.77
72588510|NCT04075682|144708193|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|0.73|STANDARD_ERROR_OF_MEAN|1.1||0.51|TWO_SIDED|95.0|-1.43|2.88||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects ordinal regression models that accounted for repeated measures at both the day- and individual-levels.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6a assessment, which evaluates moderation of the pre-specified H1 assessment. We expected that the effect of inserts (averaged over pictorial warnings) compared to no inserts (averaged over pictorial warnings) on the outcome would be stronger for those with higher than lower literacy (see Statistical Analysis Plan, Model 5).||2.88|-1.43|0.51
72588511|NCT04075682|144708193|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|2.02|STANDARD_ERROR_OF_MEAN|1.02||0.05|TWO_SIDED|95.0|0.02|4.01||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordinal regression models that accounted for repeated measures at both the day- and individual-levels.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6a assessment, which evaluates moderation of the pre-specified H1 assessment. We expected that the effect of inserts (averaged over pictorial warnings) compared to no inserts (averaged over pictorial warnings) on the outcome would be stronger for those with lower than higher delayed discounting (see Statistical Analysis Plan, Model 5).||4.01|0.02|0.05
72414090|NCT01458574|144337128|SUPERIORITY_OR_OTHER||Difference in percentage|46.2|||<|0.0001|TWO_SIDED|95.0|31.0|61.4|||CMH chi-square test|||At Week 52: P-value based on CMH chi-square test stratified by induction study treatment. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||61.4|31.0|<0.0001
72588512|NCT04075682|144708193|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|-0.91|STANDARD_ERROR_OF_MEAN|1.49||0.54|TWO_SIDED|95.0|-3.84|2.02||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects ordinal regression models that accounted for repeated measures at both the day- and individual-levels.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6b assessment, which evaluated whether the moderation of insert effects would vary by whether the inserts included pictorial warnings or not. We expected that moderation by baseline education would be stronger for insert only (vs control) than for inserts AND pictorial warnings (vs control) (see Statistical Analysis Plan, Model 5).||2.02|-3.84|0.54
72588513|NCT04075682|144708193|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|2.02|STANDARD_ERROR_OF_MEAN|1.61||0.21|TWO_SIDED|95.0|-1.13|5.17||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects ordinal regression models that accounted for repeated measures at both the day- and individual-levels.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6b assessment, which evaluated whether the moderation of insert effects would vary by whether the inserts included pictorial warnings or not. We expected that moderation by baseline literacy would be larger for insert only (vs control) than for inserts AND pictorial warnings (vs control) (see Statistical Analysis Plan, Model 5).||5.17|-1.13|0.21
72588514|NCT04075682|144708193|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|-1.07|STANDARD_ERROR_OF_MEAN|1.48||0.47|TWO_SIDED|95.0|-3.97|1.83||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects ordinal regression models that accounted for repeated measures at both the day- and individual-levels.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6b assessment, which evaluated whether the moderation of insert effects would vary by whether the inserts included pictorial warnings or not. We expected that moderation by baseline delay discounting would be larger for insert only (vs control) than for inserts AND pictorial warnings (vs control) (see Statistical Analysis Plan, Model 5).||1.83|-3.97|0.47
72588515|NCT04075682|144708194|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|0.28|STANDARD_ERROR_OF_MEAN|0.49||0.57|TWO_SIDED|95.0|-0.68|1.24||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordinal regression models that accounted for repeated measures at both the day- and individual-levels.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the pre-specified H1 assessment (see Statistical Analysis Plan, Model 1), comparing groups that received inserts (insert only AND insert + pictorial warnings) with the groups that did not (pictorial warning only AND control). We expected that the outcome would be higher in the insert groups than in the no insert groups.||1.24|-0.68|0.57
72588516|NCT04075682|144708194|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|-1.25|STANDARD_ERROR_OF_MEAN|0.71||0.08|TWO_SIDED|95.0|-2.63|0.14||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordinal regression models that accounted for repeated measures at both the day- and individual-levels.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the pre-specified H3 assessment (see Statistical Analysis Plan, Model 1), comparing the group that received inserts and pictorial warnings with the group that received inserts only. We expected that this outcome would be higher in the insert and pictorial warning group than in the insert only group.||0.14|-2.63|0.08
72588517|NCT04075682|144708194|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|-0.6|STANDARD_ERROR_OF_MEAN|0.7||0.39|TWO_SIDED|95.0|-1.97|0.77||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordinal regression models that accounted for repeated measures at both the day- and individual-levels.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the pre-specified H4 assessment, comparing the group that received inserts and pictorial warnings with the group that received pictorial warnings only. We expected that this outcome would be higher in the insert and pictorial warning group than in the pictorial warning only group.||0.77|-1.97|0.39
72588518|NCT04075682|144708194|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|0.51|STANDARD_ERROR_OF_MEAN|1.0||0.61|TWO_SIDED|95.0|-1.45|2.47||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects ordinal regression models that accounted for repeated measures at both the day- and individual-levels.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6a assessment, which evaluates moderation of the pre-specified H1 assessment. We expected that the effect of inserts (averaged over pictorial warnings) compared to no inserts (averaged over pictorial warnings) on the outcome would be stronger for those with higher than lower education (see Statistical Analysis Plan, Model 5).||2.47|-1.45|0.61
72588519|NCT04075682|144708194|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|-0.13|STANDARD_ERROR_OF_MEAN|1.07||0.9|TWO_SIDED|95.0|-2.23|1.97||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects ordinal regression models that accounted for repeated measures at both the day- and individual-levels.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6a assessment, which evaluates moderation of the pre-specified H1 assessment. We expected that the effect of inserts (averaged over pictorial warnings) compared to no inserts (averaged over pictorial warnings) on the outcome would be stronger for those with higher than lower literacy (see Statistical Analysis Plan, Model 5).||1.97|-2.23|0.90
72588520|NCT04075682|144708194|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|2.05|STANDARD_ERROR_OF_MEAN|0.98||0.04|TWO_SIDED|95.0|0.13|3.97||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects ordinal regression models that accounted for repeated measures at both the day- and individual-levels.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6a assessment, which evaluates moderation of the pre-specified H1 assessment. We expected that the effect of inserts (averaged over pictorial warnings) compared to no inserts (averaged over pictorial warnings) on the outcome would be stronger for those with lower than higher delayed discounting (see Statistical Analysis Plan, Model 5).||3.97|0.13|0.04
72588521|NCT04075682|144708194|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|0.67|STANDARD_ERROR_OF_MEAN|1.43||0.64|TWO_SIDED|95.0|-2.14|3.48||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects ordinal regression models that accounted for repeated measures at both the day- and individual-levels.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6b assessment, which evaluated whether the moderation of insert effects would vary by whether the inserts included pictorial warnings or not. We expected that moderation by baseline education would be stronger for insert only (vs control) than for inserts AND pictorial warnings (vs control) (see Statistical Analysis Plan, Model 5).||3.48|-2.14|0.64
72588522|NCT04075682|144708194|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|0.15|STANDARD_ERROR_OF_MEAN|1.56||0.92|TWO_SIDED|95.0|-2.91|3.2||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects ordinal regression models that accounted for repeated measures at both the day- and individual-levels.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6b assessment, which evaluated whether the moderation of insert effects would vary by whether the inserts included pictorial warnings or not. We expected that moderation by baseline literacy would be larger for insert only (vs control) than for inserts AND pictorial warnings (vs control) (see Statistical Analysis Plan, Model 5).||3.20|-2.91|0.92
72588523|NCT04075682|144708194|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|-2.25|STANDARD_ERROR_OF_MEAN|1.41||0.11|TWO_SIDED|95.0|-5.02|0.52||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects ordinal regression models that accounted for repeated measures at both the day- and individual-levels.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6b assessment, which evaluated whether the moderation of insert effects would vary by whether the inserts included pictorial warnings or not. We expected that moderation by baseline delay discounting would be larger for insert only (vs control) than for inserts AND pictorial warnings (vs control) (see Statistical Analysis Plan, Model 5).||0.52|-5.02|0.11
72414091|NCT01458574|144337129|SUPERIORITY_OR_OTHER||Difference in percentage|31.8|||<|0.0001|TWO_SIDED|95.0|18.8|44.8|||CMH chi-square test|||P-value based on CMH chi-square test stratified by induction study treatment. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||44.8|18.8|<0.0001
72588524|NCT04075682|144708195|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|-0.33|STANDARD_ERROR_OF_MEAN|0.59||0.57|TWO_SIDED|95.0|-1.48|0.82||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects ordinal regression models that accounted for repeated measures at both the day- and individual-levels.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the pre-specified H2 assessment (see Statistical Analysis Plan, Model 1), comparing groups that received pictorial warnings (pictorial warning only AND insert + pictorial warnings) with the groups that did not (insert only AND control). We expected that the outcome would be higher in the pictorial warning groups than in the no pictorial warning groups.||0.82|-1.48|0.57
72588525|NCT04075682|144708195|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|-0.97|STANDARD_ERROR_OF_MEAN|1.14||0.39|TWO_SIDED|95.0|-3.22|1.27||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordinal regression models that accounted for repeated measures at both the day- and individual-levels.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H5a assessment, which evaluates moderation of the pre-specified H2 assessment. We expected that the effect of pictorial warnings (averaged over insert) vs no pictorial warnings (averaged over insert) on the outcome would be stronger for higher vs lower self-efficacy (see Statistical Analysis Plan, Model 4)||1.27|-3.22|0.39
72588526|NCT04075682|144708195|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|-0.16|STANDARD_ERROR_OF_MEAN|1.63||0.92|TWO_SIDED|95.0|-3.35|3.04||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordinal regression models that accounted for repeated measures at both the day- and individual-levels.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H5b assessment, which evaluates whether moderation of pictorial warnings effects would vary by whether the pictorial warnings included inserts or not. We expected that moderation effects of baseline self-efficacy would be larger for pictorial warnings only (vs control) than for pictorial warnings AND inserts (vs control) (see Statistical Analysis Plan, Model 4).||3.04|-3.35|0.92
72588527|NCT04075682|144708196|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|-0.4|STANDARD_ERROR_OF_MEAN|0.48||0.4|TWO_SIDED|95.0|-1.33|0.53||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects ordinal regression models that accounted for repeated measures at both the day- and individual-levels.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the pre-specified H2 assessment (see Statistical Analysis Plan, Model 1), comparing groups that received pictorial warnings (pictorial warning only AND insert + pictorial warnings) with the groups that did not (insert only AND control). We expected that the outcome would be higher in the pictorial warning groups than in the no pictorial warning groups.||0.53|-1.33|0.40
72588528|NCT04075682|144708196|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|0.01|STANDARD_ERROR_OF_MEAN|0.94||0.99|TWO_SIDED|95.0|-1.83|1.86||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects ordinal regression models that accounted for repeated measures at both the day- and individual-levels.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H5a assessment, which evaluates moderation of the pre-specified H2 assessment. We expected that the effect of pictorial health warning labels (HWLs) (averaged over insert) vs no pictorial HWLs (averaged over insert) on the outcome would be stronger for higher vs lower self-efficacy (see Statistical Analysis Plan, Model 4).||1.86|-1.83|0.99
72588529|NCT04075682|144708196|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|1.85|STANDARD_ERROR_OF_MEAN|1.34||0.17|TWO_SIDED|95.0|-0.78|4.48||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects ordinal regression models that accounted for repeated measures at both the day- and individual-levels.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H5b assessment, which evaluates whether moderation of pictorial warnings effects would vary by whether the pictorial warnings included inserts or not. We expected that moderation effects of baseline self-efficacy would be larger for pictorial warnings only (vs control) than for pictorial warnings AND inserts (vs control) (see Statistical Analysis Plan, Model 4).||4.48|-0.78|0.17
72588530|NCT04075682|144708197|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|0.44|STANDARD_ERROR_OF_MEAN|0.58||0.45|TWO_SIDED|95.0|-0.69|1.57||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordinal regression models that accounted for repeated measures at both the day- and individual-levels.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the pre-specified H1 assessment (see Statistical Analysis Plan, Model 1), comparing groups that received inserts (insert only AND insert + pictorial warnings) with the groups that did not (pictorial warning only AND control). We expected that the outcome would be higher in the insert groups than in the no insert groups.||1.57|-0.69|0.45
72588531|NCT04075682|144708197|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|-0.48|STANDARD_ERROR_OF_MEAN|0.58||0.41|TWO_SIDED|95.0|-1.61|0.66||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordinal regression models that accounted for repeated measures at both the day- and individual-levels.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the pre-specified H2 assessment (see Statistical Analysis Plan, Model 1), comparing groups that received pictorial warnings (pictorial warning only AND insert + pictorial warnings) with the groups that did not (insert only AND control). We expected that the outcome would be higher in the pictorial warning groups than in the no pictorial warning groups.||0.66|-1.61|0.41
72588532|NCT04075682|144708197|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|-1.44|STANDARD_ERROR_OF_MEAN|0.84||0.08|TWO_SIDED|95.0|-3.08|0.2||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordinal regression models that accounted for repeated measures at both the day- and individual-levels.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the pre-specified H3 assessment (see Statistical Analysis Plan, Model 1), comparing the group that received inserts and pictorial warnings with the group that received inserts only. We expected that this outcome would be higher in the insert and pictorial warning group than in the insert only group.||0.20|-3.08|0.08
72588533|NCT04075682|144708197|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|-0.52|STANDARD_ERROR_OF_MEAN|0.82||0.52|TWO_SIDED|95.0|-2.14|1.09||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordinal regression models that accounted for repeated measures at both the day- and individual-levels.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the pre-specified H4 assessment (see Statistical Analysis Plan, Model 1), comparing the group that received inserts and pictorial warnings with the group that received pictorial warnings only. We expected that this outcome would be higher in the insert and pictorial warning group than in the pictorial warning only group.||1.09|-2.14|0.52
72588534|NCT04075682|144708197|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|0.35|STANDARD_ERROR_OF_MEAN|1.11||0.75|TWO_SIDED|95.0|-1.82|2.51||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects ordinal regression models that accounted for repeated measures at both the day- and individual-levels.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H5a assessment, which evaluates moderation of the pre-specified H2 assessment. We expected that the effect of pictorial HWLs (averaged over insert) vs no pictorial HWLs (averaged over insert) on the outcome would be stronger for higher vs lower self-efficacy (see Statistical Analysis Plan, Model 4).||2.51|-1.82|0.75
72588535|NCT04075682|144708197|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|-0.74|STANDARD_ERROR_OF_MEAN|1.57||0.64|TWO_SIDED|95.0|-3.82|2.33||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordinal regression models that accounted for repeated measures at both the day- and individual-levels.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H5b assessment, which evaluates whether moderation of pictorial warnings effects would vary by whether the pictorial warnings included inserts or not. We expected that moderation effects of baseline self-efficacy would be larger for pictorial warnings only (vs control) than for pictorial warnings AND inserts (vs control) (see Statistical Analysis Plan, Model 4).||2.33|-3.82|0.64
72588536|NCT04075682|144708197|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|0.14|STANDARD_ERROR_OF_MEAN|1.18||0.91|TWO_SIDED|95.0|-2.17|2.45||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects ordinal regression models that accounted for repeated measures at both the day- and individual-levels.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6a assessment, which evaluates moderation of the pre-specified H1 assessment. We expected that the effect of inserts (averaged over pictorial warnings) compared to no inserts (averaged over pictorial warnings) on the outcome would be stronger for those with higher than lower education (see Statistical Analysis Plan, Model 5).||2.45|-2.17|0.91
72588537|NCT04075682|144708197|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|-0.84|STANDARD_ERROR_OF_MEAN|1.25||0.5|TWO_SIDED|95.0|-3.29|1.6||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects ordinal regression models that accounted for repeated measures at both the day- and individual-levels.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6a assessment, which evaluates moderation of the pre-specified H1 assessment. We expected that the effect of inserts (averaged over pictorial warnings) compared to no inserts (averaged over pictorial warnings) on the outcome would be stronger for those with higher than lower literacy (see Statistical Analysis Plan, Model 5).||1.60|-3.29|0.50
72588538|NCT04075682|144708197|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|3.14|STANDARD_ERROR_OF_MEAN|1.16||0.007|TWO_SIDED|95.0|0.86|5.41||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects ordinal regression models that accounted for repeated measures at both the day- and individual-levels.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6a assessment, which evaluates moderation of the pre-specified H1 assessment. We expected that the effect of inserts (averaged over pictorial warnings) compared to no inserts (averaged over pictorial warnings) on the outcome would be stronger for those with lower than higher delayed discounting (see Statistical Analysis Plan, Model 5).||5.41|0.86|0.007
72588539|NCT04075682|144708197|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|1.09|STANDARD_ERROR_OF_MEAN|1.69||0.52|TWO_SIDED|95.0|-2.22|4.4||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects ordinal regression models that accounted for repeated measures at both the day- and individual-levels.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6b assessment, which evaluated whether the moderation of insert effects would vary by whether the inserts included pictorial warnings or not. We expected that moderation by baseline education would be stronger for insert only (vs control) than for inserts AND pictorial warnings (vs control) (see Statistical Analysis Plan, Model 5).||4.40|-2.22|0.52
72414092|NCT01458574|144337129|SUPERIORITY_OR_OTHER||Difference in percentage|42.2|||<|0.0001|TWO_SIDED|95.0|27.9|56.5|||CMH chi-square test|||P-value based on CMH chi-square test stratified by induction study treatment. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||56.5|27.9|<0.0001
72414093|NCT01458574|144337130|SUPERIORITY_OR_OTHER||Difference in percentage|38.6|||<|0.0001|TWO_SIDED|95.0|23.4|53.8|||CMH chi-square test|||At Week 24: P-value based on CMH chi-square test stratified by induction study treatment. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||53.8|23.4|<0.0001
72414094|NCT01458574|144337130|SUPERIORITY_OR_OTHER||Difference in percentage|48.4|||<|0.0001|TWO_SIDED|95.0|32.7|64.1|||CMH chi-square test|||At Week 24: P-value based on CMH chi-square test stratified by induction study treatment. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||64.1|32.7|<0.0001
72588540|NCT04075682|144708197|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|-0.33|STANDARD_ERROR_OF_MEAN|1.82||0.86|TWO_SIDED|95.0|-3.89|3.23||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects ordinal regression models that accounted for repeated measures at both the day- and individual-levels.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6b assessment, which evaluated whether the moderation of insert effects would vary by whether the inserts included pictorial warnings or not. We expected that moderation by baseline literacy would be larger for insert only (vs control) than for inserts AND pictorial warnings (vs control) (see Statistical Analysis Plan, Model 5).||3.23|-3.89|0.86
72414095|NCT01458574|144337130|SUPERIORITY_OR_OTHER||Difference in percentage|34.4|||<|0.0001|TWO_SIDED|95.0|20.1|48.8|||CMH chi-square test|||At Week 52: P-value based on CMH chi-square test stratified by induction study treatment. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||48.8|20.1|<0.0001
72588541|NCT04075682|144708197|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|-0.86|STANDARD_ERROR_OF_MEAN|1.68||0.61|TWO_SIDED|95.0|-4.15|2.43||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects ordinal regression models that accounted for repeated measures at both the day- and individual-levels.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6b assessment, which evaluated whether the moderation of insert effects would vary by whether the inserts included pictorial warnings or not. We expected that moderation by baseline delay discounting would be larger for insert only (vs control) than for inserts AND pictorial warnings (vs control) (see Statistical Analysis Plan, Model 5).||2.43|-4.15|0.61
72588542|NCT04075682|144708198|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|1.26|STANDARD_ERROR_OF_MEAN|0.28||0.29|TWO_SIDED|95.0|0.82|1.96||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the pre-specified H1 assessment (see Statistical Analysis Plan, Model 1), comparing groups that received inserts (insert only AND insert + pictorial warnings) with the groups that did not (pictorial warning only AND control). We expected that the outcome would be higher in the insert groups than in the no insert groups.||1.96|0.82|0.29
72588543|NCT04075682|144708198|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|1.19|STANDARD_ERROR_OF_MEAN|0.27||0.43|TWO_SIDED|95.0|0.77|1.85||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the pre-specified H2 assessment (see Statistical Analysis Plan, Model 1), comparing groups that received pictorial warnings (pictorial warning only AND insert + pictorial warnings) with the groups that did not (insert only AND control). We expected that the outcome would be higher in the pictorial warning groups than in the no pictorial warning groups.||1.85|0.77|0.43
72588544|NCT04075682|144708198|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|1.18|STANDARD_ERROR_OF_MEAN|0.37||0.6|TWO_SIDED|95.0|0.63|2.2||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the pre-specified H3 assessment (see Statistical Analysis Plan, Model 1), comparing the group that received inserts and pictorial warnings with the group that received inserts only. We expected that this outcome would be higher in the insert and pictorial warning group than in the insert only group.||2.20|0.63|0.60
72588545|NCT04075682|144708198|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|1.25|STANDARD_ERROR_OF_MEAN|0.4||0.48|TWO_SIDED|95.0|0.67|2.33||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the pre-specified H4 assessment (see Statistical Analysis Plan, Model 1), comparing the group that received inserts and pictorial warnings with the group that received pictorial warnings only. We expected that this outcome would be higher in the insert and pictorial warning group than in the pictorial warning only group.||2.33|0.67|0.48
72588546|NCT04075682|144708198|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|0.8|STANDARD_ERROR_OF_MEAN|0.36||0.62|TWO_SIDED|95.0|0.34|1.91||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H5a assessment, which evaluates moderation of the pre-specified H2 assessment. We expected that the effect of pictorial HWLs (averaged over insert) vs no pictorial HWLs (averaged over insert) on the outcome would be stronger for higher vs lower self-efficacy (see Statistical Analysis Plan, Model 4).||1.91|0.34|0.62
72588547|NCT04075682|144708198|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|3.04|STANDARD_ERROR_OF_MEAN|1.93||0.079|TWO_SIDED|95.0|0.88|10.52||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H5b assessment, which evaluates whether moderation of pictorial warnings effects would vary by whether the pictorial warnings included inserts or not. We expected that moderation effects of baseline self-efficacy would be larger for pictorial warnings only (vs control) than for pictorial warnings AND inserts (vs control) (see Statistical Analysis Plan, Model 4).||10.52|0.88|0.079
72588548|NCT04075682|144708198|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|2.1|STANDARD_ERROR_OF_MEAN|0.95||0.1|TWO_SIDED|95.0|0.87|5.12||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6a assessment, which evaluates moderation of the pre-specified H1 assessment. We expected that the effect of inserts (averaged over pictorial warnings) compared to no inserts (averaged over pictorial warnings) on the outcome would be stronger for those with higher than lower education (see Statistical Analysis Plan, Model 5).||5.12|0.87|0.10
72588549|NCT04075682|144708198|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|1.38|STANDARD_ERROR_OF_MEAN|0.68||0.52|TWO_SIDED|95.0|0.52|3.61||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6a assessment, which evaluates moderation of the pre-specified H1 assessment. We expected that the effect of inserts (averaged over pictorial warnings) compared to no inserts (averaged over pictorial warnings) on the outcome would be stronger for those with higher than lower literacy (see Statistical Analysis Plan, Model 5).||3.61|0.52|0.52
72588550|NCT04075682|144708198|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|1.32|STANDARD_ERROR_OF_MEAN|0.59||0.54|TWO_SIDED|95.0|0.55|3.17||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6a assessment, which evaluates moderation of the pre-specified H1 assessment. We expected that the effect of inserts (averaged over pictorial warnings) compared to no inserts (averaged over pictorial warnings) on the outcome would be stronger for those with lower than higher delayed discounting (see Statistical Analysis Plan, Model 5).||3.17|0.55|0.54
72588551|NCT04075682|144708198|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|1.88|STANDARD_ERROR_OF_MEAN|1.21||0.33|TWO_SIDED|95.0|0.53|6.61||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6b assessment, which evaluated whether the moderation of insert effects would vary by whether the inserts included pictorial warnings or not. We expected that moderation by baseline education would be stronger for insert only (vs control) than for inserts AND pictorial warnings (vs control) (see Statistical Analysis Plan, Model 5).||6.61|0.53|0.33
72588552|NCT04075682|144708198|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|1.53|STANDARD_ERROR_OF_MEAN|1.08||0.55|TWO_SIDED|95.0|0.38|6.11||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6b assessment, which evaluated whether the moderation of insert effects would vary by whether the inserts included pictorial warnings or not. We expected that moderation by baseline literacy would be larger for insert only (vs control) than for inserts AND pictorial warnings (vs control) (see Statistical Analysis Plan, Model 5).||6.11|0.38|0.55
72588553|NCT04075682|144708198|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|0.61|STANDARD_ERROR_OF_MEAN|0.39||0.44|TWO_SIDED|95.0|0.18|2.14||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6b assessment, which evaluated whether the moderation of insert effects would vary by whether the inserts included pictorial warnings or not. We expected that moderation by baseline delay discounting would be larger for insert only (vs control) than for inserts AND pictorial warnings (vs control) (see Statistical Analysis Plan, Model 5).||2.14|0.18|0.44
72588554|NCT04075682|144708198|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|1.29|STANDARD_ERROR_OF_MEAN|0.28||0.251|TWO_SIDED|95.0|0.84|1.98||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the multiple imputation models for pre-specified H1 assessment (see Statistical Analysis Plan, Model 1), comparing groups that received inserts (insert only AND insert + pictorial warnings) with the groups that did not (pictorial warning only AND control). We expected that the outcome would be higher in the insert groups than in the no insert groups.||1.98|0.84|0.2510
72588555|NCT04075682|144708198|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|1.27|STANDARD_ERROR_OF_MEAN|0.28||0.2822|TWO_SIDED|95.0|0.82|1.95||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the multiple imputation model for the pre-specified H2 assessment (see Statistical Analysis Plan, Model 1), comparing groups that received pictorial warnings (pictorial warning only AND insert + pictorial warnings) with the groups that did not (insert only AND control). We expected that the outcome would be higher in the pictorial warning groups than in the no pictorial warning groups.||1.95|0.82|0.2822
72588556|NCT04075682|144708198|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|1.34|STANDARD_ERROR_OF_MEAN|0.42||0.3558|TWO_SIDED|95.0|0.72|2.47||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for multiple imputation models for the pre-specified H3 assessment (see Statistical Analysis Plan, Model 1), comparing the group that received inserts and pictorial warnings with the group that received inserts only. We expected that this outcome would be higher in the insert and pictorial warning group than in the insert only group.||2.47|0.72|0.3558
72414096|NCT01458574|144337130|SUPERIORITY_OR_OTHER||Difference in percentage|46.2|||<|0.0001|TWO_SIDED|95.0|31.0|61.4|||CMH chi-square test|||At Week 52: P-value based on CMH chi-square test stratified by induction study treatment. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||61.4|31.0|<0.0001
72588557|NCT04075682|144708198|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|1.36|STANDARD_ERROR_OF_MEAN|0.43||0.3291|TWO_SIDED|95.0|0.73|2.51||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the multiple imputation model for the pre-specified H4 assessment (see Statistical Analysis Plan, Model 1), comparing the group that received inserts and pictorial warnings with the group that received pictorial warnings only. We expected that this outcome would be higher in the insert and pictorial warning group than in the pictorial warning only group.||2.51|0.73|0.3291
72588558|NCT04075682|144708198|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|0.89|STANDARD_ERROR_OF_MEAN|0.39||0.7818|TWO_SIDED|95.0|0.38|2.09||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are from the multiple imputation model for the intended (but not correctly pre-specified) H5a assessment, which evaluates moderation of the pre-specified H2 assessment. We expected that the effect of pictorial HWLs (averaged over insert) vs no pictorial HWLs (averaged over insert) on the outcome would be stronger for higher vs lower self-efficacy (see Statistical Analysis Plan, Model 4).||2.09|0.38|0.7818
72588559|NCT04075682|144708198|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|2.87|STANDARD_ERROR_OF_MEAN|1.79||0.0912|TWO_SIDED|95.0|0.84|9.73||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are from the multiple imputation model for the intended (but not correctly pre-specified) H5b assessment, which evaluates whether moderation of pictorial warnings effects would vary by whether the pictorial warnings included inserts or not. We expected that moderation effects of baseline self-efficacy would be larger for pictorial warnings only (vs control) than for pictorial warnings AND inserts (vs control) (see Statistical Analysis Plan, Model 4).||9.73|0.84|0.0912
72588560|NCT04075682|144708198|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|1.94|STANDARD_ERROR_OF_MEAN|0.87||0.1361|TWO_SIDED|95.0|0.81|4.66||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are from the multiple imputation model for the intended (but not correctly pre-specified) H6a assessment, which evaluates moderation of the pre-specified H1 assessment. We expected that the effect of inserts (averaged over pictorial warnings) compared to no inserts (averaged over pictorial warnings) on the outcome would be stronger for those with higher than lower education (see Statistical Analysis Plan, Model 5).||4.66|0.81|0.1361
72369799|NCT01149148|144249955|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.3333|STANDARD_DEVIATION|1.626||0.678|TWO_SIDED|95.0|-1.36|2.02||A prior threshold for statistical significance is p \< 0.05|t-test, 2 sided||The difference between baseline and three months is (baseline - 3 month). The difference in control and intervention is (intervention - control), which in this case is (unblinded - blinded).|The goal was to determine whether cerebral oximetry monitoring during surgery affected cognitive outcomes. Cerebral Oximetry Monitoring unblinded (intervention), and Cerebral Oxymetry Monitoring blinded (control) were given Mini Mental State Exam prior to surgery and three months after surgery. The differences between baseline and 3 month were calculated and compared between the intervention and control groups using t-test.||2.02|-1.36|0.678
72414097|NCT01458574|144337131|SUPERIORITY_OR_OTHER||Difference in percentage|12.9||||0.0074|TWO_SIDED|95.0|2.6|23.2|||CMH chi-square test|||At Week 24: P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||23.2|2.6|0.0074
72588561|NCT04075682|144708198|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|1.19|STANDARD_ERROR_OF_MEAN|0.58||0.72|TWO_SIDED|95.0|0.46|3.07||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the multiple imputation model for the intended (but not correctly pre-specified) H6a assessment, which evaluates moderation of the pre-specified H1 assessment. We expected that the effect of inserts (averaged over pictorial warnings) compared to no inserts (averaged over pictorial warnings) on the outcome would be stronger for those with higher than lower literacy (see Statistical Analysis Plan, Model 5).||3.07|0.46|0.7200
72588562|NCT04075682|144708198|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|1.48|STANDARD_ERROR_OF_MEAN|0.66||0.3737|TWO_SIDED|95.0|0.62|3.53||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are from the multiple imputation model for the intended (but not correctly pre-specified) H6a assessment, which evaluates moderation of the pre-specified H1 assessment. We expected that the effect of inserts (averaged over pictorial warnings) compared to no inserts (averaged over pictorial warnings) on the outcome would be stronger for those with lower than higher delayed discounting (see Statistical Analysis Plan, Model 5).||3.53|0.62|0.3737
72588563|NCT04075682|144708198|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|2.58|STANDARD_ERROR_OF_MEAN|1.63||0.1345|TWO_SIDED|95.0|0.75|8.9||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are from the multiple imputation model for the intended (but not correctly pre-specified) H6b assessment, which evaluated whether the moderation of insert effects would vary by whether the inserts included pictorial warnings or not. We expected that moderation by baseline education would be stronger for insert only (vs control) than for inserts AND pictorial warnings (vs control) (see Statistical Analysis Plan, Model 5).||8.90|0.75|0.1345
72588564|NCT04075682|144708198|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|1.96|STANDARD_ERROR_OF_MEAN|1.36||0.3318|TWO_SIDED|95.0|0.5|7.67||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are from the multiple imputation model for the intended (but not correctly pre-specified) H6b assessment, which evaluated whether the moderation of insert effects would vary by whether the inserts included pictorial warnings or not. We expected that moderation by baseline literacy would be larger for insert only (vs control) than for inserts AND pictorial warnings (vs control) (see Statistical Analysis Plan, Model 5).||7.67|0.50|0.3318
72588565|NCT04075682|144708198|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|0.79|STANDARD_ERROR_OF_MEAN|0.49||0.7017|TWO_SIDED|95.0|0.23|2.7||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are from the multiple imputation model for the intended (but not correctly pre-specified) H6b assessment, which evaluated whether the moderation of insert effects would vary by whether the inserts included pictorial warnings or not. We expected that moderation by baseline delay discounting would be larger for insert only (vs control) than for inserts AND pictorial warnings (vs control) (see Statistical Analysis Plan, Model 5).||2.70|0.23|0.7017
72588566|NCT04075682|144708199|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|2.47|STANDARD_ERROR_OF_MEAN|0.7||0.001|TWO_SIDED|95.0|1.42|4.31||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the pre-specified H1 assessment (see Statistical Analysis Plan, Model 1), comparing groups that received inserts (insert only AND insert + pictorial warnings) with the groups that did not (pictorial warning only AND control). We expected that the outcome would be higher in the insert groups than in the no insert groups.||4.31|1.42|0.001
72588567|NCT04075682|144708199|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|1.89|STANDARD_ERROR_OF_MEAN|0.54||0.025|TWO_SIDED|95.0|1.09|3.3||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the pre-specified H2 assessment (see Statistical Analysis Plan, Model 1), comparing groups that received pictorial warnings (pictorial warning only AND insert + pictorial warnings) with the groups that did not (insert only AND control). We expected that the outcome would be higher in the pictorial warning groups than in the no pictorial warning groups.||3.30|1.09|0.025
72588568|NCT04075682|144708199|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|1.37|STANDARD_ERROR_OF_MEAN|0.56||0.44|TWO_SIDED|95.0|0.62|3.06||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the pre-specified H3 assessment (see Statistical Analysis Plan, Model 1), comparing the group that received inserts and pictorial warnings with the group that received inserts only. We expected that this outcome would be higher in the insert and pictorial warning group than in the insert only group.||3.06|0.62|0.44
72588569|NCT04075682|144708199|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|1.8|STANDARD_ERROR_OF_MEAN|0.73||0.15|TWO_SIDED|95.0|0.81|3.97||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the pre-specified H4 assessment (see Statistical Analysis Plan, Model 1), comparing the group that received inserts and pictorial warnings with the group that received pictorial warnings only. We expected that this outcome would be higher in the insert and pictorial warning group than in the pictorial warning only group.||3.97|0.81|0.15
72369800|NCT03436082|144249957|OTHER|We used Stata version 14.2 (StataCorp LP) to perform chi-square tests to compare syncing of the Fitbit device and response rate for the postprocedure recovery PROMs and disease-specific PROMs between patients in the bariatric surgery and atrial fibrillation ablation groups, using a p value \< 0.05 to denote statistical significance.||||||0.04|||||||Chi-squared|||||||0.04
72588570|NCT04075682|144708199|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|1.19|STANDARD_ERROR_OF_MEAN|0.67||0.76|TWO_SIDED|95.0|0.39|3.58||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H5a assessment, which evaluates moderation of the pre-specified H2 assessment. We expected that the effect of pictorial HWLs (averaged over insert) vs no pictorial HWLs (averaged over insert) on the outcome would be stronger for higher vs lower self-efficacy (see Statistical Analysis Plan, Model 4).||3.58|0.39|0.76
72588571|NCT04075682|144708199|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|0.79|STANDARD_ERROR_OF_MEAN|0.63||0.77|TWO_SIDED|95.0|0.16|3.8||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H5b assessment, which evaluates whether moderation of pictorial warnings effects would vary by whether the pictorial warnings included inserts or not. We expected that moderation effects of baseline self-efficacy would be larger for pictorial warnings only (vs control) than for pictorial warnings AND inserts (vs control) (see Statistical Analysis Plan, Model 4).||3.80|0.16|0.77
72588572|NCT04075682|144708199|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|2.18|STANDARD_ERROR_OF_MEAN|1.23||0.17|TWO_SIDED|95.0|0.72|6.61||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6a assessment, which evaluates moderation of the pre-specified H1 assessment. We expected that the effect of inserts (averaged over pictorial warnings) compared to no inserts (averaged over pictorial warnings) on the outcome would be stronger for those with higher than lower education (see Statistical Analysis Plan, Model 5).||6.61|0.72|0.17
72588573|NCT04075682|144708199|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|0.46|STANDARD_ERROR_OF_MEAN|0.29||0.22|TWO_SIDED|95.0|0.14|1.57||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6a assessment, which evaluates moderation of the pre-specified H1 assessment. We expected that the effect of inserts (averaged over pictorial warnings) compared to no inserts (averaged over pictorial warnings) on the outcome would be stronger for those with higher than lower literacy (see Statistical Analysis Plan, Model 5).||1.57|0.14|0.22
72588574|NCT04075682|144708199|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|3.45|STANDARD_ERROR_OF_MEAN|1.94||0.02|TWO_SIDED|95.0|1.15|10.37||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6a assessment, which evaluates moderation of the pre-specified H1 assessment. We expected that the effect of inserts (averaged over pictorial warnings) compared to no inserts (averaged over pictorial warnings) on the outcome would be stronger for those with lower than higher delayed discounting (see Statistical Analysis Plan, Model 5).||10.37|1.15|0.02
72369801|NCT03436082|144249959|OTHER|We used Stata version 14.2 (StataCorp LP) to perform chi-square tests to compare syncing of the Fitbit device and response rate for the postprocedure recovery PROMs and disease-specific PROMs between patients in the bariatric surgery and atrial fibrillation ablation groups, using a p value \< 0.05 to denote statistical significance.||||||0.85|||||||Chi-squared|||||||0.85
72369802|NCT00950859|144249962|SUPERIORITY_OR_OTHER||percentage of participants|78.0|||||TWO_SIDED|95.0|58.0|91.0|||||The estimated value represents the percentage of participants with HIV-1 RNA \<400 c/mL or at least 0.7 log10 c/mL below their Baseline value at Day 11.|||91|58|
72588575|NCT04075682|144708199|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|5.45|STANDARD_ERROR_OF_MEAN|4.4||0.04|TWO_SIDED|95.0|1.12|26.53||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6b assessment, which evaluated whether the moderation of insert effects would vary by whether the inserts included pictorial warnings or not. We expected that moderation by baseline education would be stronger for insert only (vs control) than for inserts AND pictorial warnings (vs control) (see Statistical Analysis Plan, Model 5).||26.53|1.12|0.04
72588576|NCT04075682|144708199|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|0.59|STANDARD_ERROR_OF_MEAN|0.53||0.56|TWO_SIDED|95.0|0.1|3.47||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6b assessment, which evaluated whether the moderation of insert effects would vary by whether the inserts included pictorial warnings or not. We expected that moderation by baseline literacy would be larger for insert only (vs control) than for inserts AND pictorial warnings (vs control) (see Statistical Analysis Plan, Model 5).||3.47|0.10|0.56
72588577|NCT04075682|144708199|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|0.55|STANDARD_ERROR_OF_MEAN|0.44||0.46|TWO_SIDED|95.0|0.11|2.68||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6b assessment, which evaluated whether the moderation of insert effects would vary by whether the inserts included pictorial warnings or not. We expected that moderation by baseline delay discounting would be larger for insert only (vs control) than for inserts AND pictorial warnings (vs control) (see Statistical Analysis Plan, Model 5).||2.68|0.11|0.46
72588578|NCT04075682|144708199|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|2.58|STANDARD_ERROR_OF_MEAN|0.66||0.0002|TWO_SIDED|95.0|1.56|4.27||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are from the multiple imputation model for the pre-specified H1 assessment (see Statistical Analysis Plan, Model 1), comparing groups that received inserts (insert only AND insert + pictorial warnings) with the groups that did not (pictorial warning only AND control). We expected that the outcome would be higher in the insert groups than in the no insert groups.||4.27|1.56|0.0002
72588579|NCT04075682|144708199|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|1.89|STANDARD_ERROR_OF_MEAN|0.48||0.0135|TWO_SIDED|95.0|1.14|3.12||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are from the multiple imputation model for the pre-specified H2 assessment (see Statistical Analysis Plan, Model 1), comparing groups that received pictorial warnings (pictorial warning only AND insert + pictorial warnings) with the groups that did not (insert only AND control). We expected that the outcome would be higher in the pictorial warning groups than in the no pictorial warning groups.||3.12|1.14|0.0135
72588580|NCT04075682|144708199|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|1.51|STANDARD_ERROR_OF_MEAN|0.56||0.2619|TWO_SIDED|95.0|0.73|3.12||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are from the multiple imputation model for the pre-specified H3 assessment (see Statistical Analysis Plan, Model 1), comparing the group that received inserts and pictorial warnings with the group that received inserts only. We expected that this outcome would be higher in the insert and pictorial warning group than in the insert only group.||3.12|0.73|0.2619
72588581|NCT04075682|144708199|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|2.07|STANDARD_ERROR_OF_MEAN|0.76||0.0474|TWO_SIDED|95.0|1.01|4.24||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are from the multiple imputation model for the pre-specified H4 assessment (see Statistical Analysis Plan, Model 1), comparing the group that received inserts and pictorial warnings with the group that received pictorial warnings only. We expected that this outcome would be higher in the insert and pictorial warning group than in the pictorial warning only group.||4.24|1.01|0.0474
72588582|NCT04075682|144708199|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|1.13|STANDARD_ERROR_OF_MEAN|0.58||0.8094|TWO_SIDED|95.0|0.42|3.07||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are from the multiple imputation model for the intended (but not correctly pre-specified) H5a assessment, which evaluates moderation of the pre-specified H2 assessment. We expected that the effect of pictorial HWLs (averaged over insert) vs no pictorial HWLs (averaged over insert) on the outcome would be stronger for higher vs lower self-efficacy (see Statistical Analysis Plan, Model 4).||3.07|0.42|0.8094
72588583|NCT04075682|144708199|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|0.83|STANDARD_ERROR_OF_MEAN|0.6||0.7978|TWO_SIDED|95.0|0.2|3.44||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are from the multiple imputation model for the intended (but not correctly pre-specified) H5b assessment, which evaluates whether moderation of pictorial warnings effects would vary by whether the pictorial warnings included inserts or not. We expected that moderation effects of baseline self-efficacy would be larger for pictorial warnings only (vs control) than for pictorial warnings AND inserts (vs control) (see Statistical Analysis Plan, Model 4).||3.44|0.20|0.7978
72588584|NCT04075682|144708199|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|2.29|STANDARD_ERROR_OF_MEAN|1.15||0.1016|TWO_SIDED|95.0|0.85|6.15||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are from the multiple imputation model for the intended (but not correctly pre-specified) H6a assessment, which evaluates moderation of the pre-specified H1 assessment. We expected that the effect of inserts (averaged over pictorial warnings) compared to no inserts (averaged over pictorial warnings) on the outcome would be stronger for those with higher than lower education (see Statistical Analysis Plan, Model 5).||6.15|0.85|0.1016
72414098|NCT01458574|144337131|SUPERIORITY_OR_OTHER||Difference in percentage|13.2||||0.0103|TWO_SIDED|95.0|2.4|24.1|||CMH chi-square test|||At Week 24: P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||24.1|2.4|0.0103
72414099|NCT01458574|144337131|SUPERIORITY_OR_OTHER||Difference in percentage|16.8||||0.0018|TWO_SIDED|95.0|6.2|27.5|||CMH chi-square test|||At Week 52: P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||27.5|6.2|0.0018
72414100|NCT01458574|144337131|SUPERIORITY_OR_OTHER||Difference in percentage|16.7||||0.0029|TWO_SIDED|95.0|5.5|27.9|||CMH chi-square test|||At Week 52: P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||27.9|5.5|0.0029
72414101|NCT01458574|144337132|SUPERIORITY_OR_OTHER||Difference in percentage|7.9||||0.0419|TWO_SIDED|95.0|0.1|15.7|||CMH chi-square test|||P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||15.7|0.1|0.0419
72414102|NCT01458574|144337132|SUPERIORITY_OR_OTHER||Difference in percentage|11.1||||0.0121|TWO_SIDED|95.0|2.3|19.9|||CMH chi-square test|||P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||19.9|2.3|0.0121
72588585|NCT04075682|144708199|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|0.45|STANDARD_ERROR_OF_MEAN|0.25||0.157|TWO_SIDED|95.0|0.15|1.36||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are from the multiple imputation model for the intended (but not correctly pre-specified) H6a assessment, which evaluates moderation of the pre-specified H1 assessment. We expected that the effect of inserts (averaged over pictorial warnings) compared to no inserts (averaged over pictorial warnings) on the outcome would be stronger for those with higher than lower literacy (see Statistical Analysis Plan, Model 5).||1.36|0.15|0.1570
72588586|NCT04075682|144708199|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|3.02|STANDARD_ERROR_OF_MEAN|1.53||0.0297|TWO_SIDED|95.0|1.11|8.18||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are from the multiple imputation model for the intended (but not correctly pre-specified) H6a assessment, which evaluates moderation of the pre-specified H1 assessment. We expected that the effect of inserts (averaged over pictorial warnings) compared to no inserts (averaged over pictorial warnings) on the outcome would be stronger for those with lower than higher delayed discounting (see Statistical Analysis Plan, Model 5).||8.18|1.11|0.0297
72588587|NCT04075682|144708199|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|5.28|STANDARD_ERROR_OF_MEAN|3.81||0.0213|TWO_SIDED|95.0|1.28|21.73||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are from the multiple imputation model for the intended (but not correctly pre-specified) H6b assessment, which evaluated whether the moderation of insert effects would vary by whether the inserts included pictorial warnings or not. We expected that moderation by baseline education would be stronger for insert only (vs control) than for inserts AND pictorial warnings (vs control) (see Statistical Analysis Plan, Model 5).||21.73|1.28|0.0213
72414103|NCT04964089|144337166|NON_INFERIORITY|The maximum clinically acceptable true difference between KSI-301 and aflibercept participants to be considered non-inferior is 4.5 ETDRS letters, i.e. the non-inferiority margin (NI) is 4.5 letters.|Adjusted mean difference|-2.1|STANDARD_ERROR_OF_MEAN|0.91||0.0083|TWO_SIDED|95.03|-3.88|-0.29|||Mixed Models Analysis|MMRM model with treatment, visit, treatment by visit interaction, randomization stratification factors, and continuous baseline BCVA as covariates.||||-0.29|-3.88|0.0083
72414104|NCT01682837|144337173|SUPERIORITY_OR_OTHER|||||||0.07|||||||Mixed Models Analysis|||||||0.07
72414105|NCT01682837|144337174|SUPERIORITY_OR_OTHER|||||||0.2|||||||Mixed Models Analysis|||||||0.20
72414106|NCT01682837|144337175|SUPERIORITY_OR_OTHER|||||||0.16|||||||Mixed Models Analysis|||||||0.16
72414107|NCT01682837|144337176|SUPERIORITY_OR_OTHER|||||||0.7|||||||Mixed Models Analysis|||||||0.70
72414108|NCT01682837|144337177|SUPERIORITY_OR_OTHER|||||||0.42|||||||Mixed Models Analysis|||||||0.42
72414109|NCT01682837|144337178|SUPERIORITY_OR_OTHER|||||||0.1|||||||Mixed Models Analysis|||||||0.10
72588588|NCT04075682|144708199|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|0.96|STANDARD_ERROR_OF_MEAN|0.78||0.9648|TWO_SIDED|95.0|0.2|4.74||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are from the multiple imputation model for the intended (but not correctly pre-specified) H6b assessment, which evaluated whether the moderation of insert effects would vary by whether the inserts included pictorial warnings or not. We expected that moderation by baseline literacy would be larger for insert only (vs control) than for inserts AND pictorial warnings (vs control) (see Statistical Analysis Plan, Model 5).||4.74|0.20|0.9648
72588589|NCT04075682|144708199|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|0.72|STANDARD_ERROR_OF_MEAN|0.53||0.6512|TWO_SIDED|95.0||||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results from the multiple imputation model are for the intended (but not correctly pre-specified) H6b assessment, which evaluated whether the moderation of insert effects would vary by whether the inserts included pictorial warnings or not. We expected that moderation by baseline delay discounting would be larger for insert only (vs control) than for inserts AND pictorial warnings (vs control) (see Statistical Analysis Plan, Model 5).||||0.6512
72588590|NCT04075682|144708200|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|0.55|STANDARD_ERROR_OF_MEAN|0.66||0.41|TWO_SIDED|95.0|-0.75|1.85||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordinal regression models that accounted for repeated measures at both the day- and individual-levels.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the pre-specified H1 assessment (see Statistical Analysis Plan, Model 1), comparing groups that received inserts (insert only AND insert + pictorial warnings) with the groups that did not (pictorial warning only AND control). We expected that the outcome would be higher in the insert groups than in the no insert groups.||1.85|-0.75|0.41
72588591|NCT04075682|144708200|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|-1.67|STANDARD_ERROR_OF_MEAN|0.96||0.08|TWO_SIDED|95.0|-3.55|0.21||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects ordinal regression models that accounted for repeated measures at both the day- and individual-levels.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the pre-specified H3 assessment (see Statistical Analysis Plan, Model 1), comparing the group that received inserts and pictorial warnings with the group that received inserts only. We expected that this outcome would be higher in the insert and pictorial warning group than in the insert only group.||0.21|-3.55|0.08
72588592|NCT04075682|144708200|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|-0.57|STANDARD_ERROR_OF_MEAN|0.95||0.55|TWO_SIDED|95.0|-2.42|1.29||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects ordinal regression models that accounted for repeated measures at both the day- and individual-levels.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the pre-specified H4 assessment (see Statistical Analysis Plan, Model 1), comparing the group that received inserts and pictorial warnings with the group that received pictorial warnings only. We expected that this outcome would be higher in the insert and pictorial warning group than in the pictorial warning only group.||1.29|-2.42|0.55
72588593|NCT04075682|144708200|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|1.2|STANDARD_ERROR_OF_MEAN|1.36||0.38|TWO_SIDED|95.0|-1.47|3.86||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects ordinal regression models that accounted for repeated measures at both the day- and individual-levels.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6a assessment, which evaluates moderation of the pre-specified H1 assessment. We expected that the effect of inserts (averaged over pictorial warnings) compared to no inserts (averaged over pictorial warnings) on the outcome would be stronger for those with higher than lower education (see Statistical Analysis Plan, Model 5).||3.86|-1.47|0.38
72369803|NCT00950859|144249962|SUPERIORITY_OR_OTHER||percentage of participants|96.0||||||95.0|79.0|100.0|||||The estimated value represents the percentage of participants with HIV-1 RNA \<400 c/mL or at least 0.7 log10 c/mL below their Baseline value at Day 11.|||100|79|
72414110|NCT01682837|144337179|SUPERIORITY_OR_OTHER|||||||0.64|||||||Mixed Models Analysis|||||||0.64
72588594|NCT04075682|144708200|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|-0.54|STANDARD_ERROR_OF_MEAN|1.44||0.71|TWO_SIDED|95.0|-3.35|2.28||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects ordinal regression models that accounted for repeated measures at both the day- and individual-levels.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6a assessment, which evaluates moderation of the pre-specified H1 assessment. We expected that the effect of inserts (averaged over pictorial warnings) compared to no inserts (averaged over pictorial warnings) on the outcome would be stronger for those with higher than lower literacy (see Statistical Analysis Plan, Model 5).||2.28|-3.35|0.71
72588595|NCT04075682|144708200|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|3.21|STANDARD_ERROR_OF_MEAN|1.34||0.02|TWO_SIDED|95.0|0.59|5.83||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordinal regression models that accounted for repeated measures at both the day- and individual-levels.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6a assessment, which evaluates moderation of the pre-specified H1 assessment. We expected that the effect of inserts (averaged over pictorial warnings) compared to no inserts (averaged over pictorial warnings) on the outcome would be stronger for those with lower than higher delayed discounting (see Statistical Analysis Plan, Model 5).||5.83|0.59|0.02
72588596|NCT04075682|144708200|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|-0.05|STANDARD_ERROR_OF_MEAN|1.94||0.98|TWO_SIDED|95.0|-3.85|3.76||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects ordinal regression models that accounted for repeated measures at both the day- and individual-levels.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6b assessment, which evaluated whether the moderation of insert effects would vary by whether the inserts included pictorial warnings or not. We expected that moderation by baseline education would be stronger for insert only (vs control) than for inserts AND pictorial warnings (vs control) (see Statistical Analysis Plan, Model 5).||3.76|-3.85|0.98
72588597|NCT04075682|144708200|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|-2.13|STANDARD_ERROR_OF_MEAN|2.08||0.31|TWO_SIDED|95.0|-6.2|1.95||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects ordinal regression models that accounted for repeated measures at both the day- and individual-levels.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6b assessment, which evaluated whether the moderation of insert effects would vary by whether the inserts included pictorial warnings or not. We expected that moderation by baseline literacy would be larger for insert only (vs control) than for inserts AND pictorial warnings (vs control) (see Statistical Analysis Plan, Model 5).||1.95|-6.2|0.31
72588598|NCT04075682|144708200|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|-0.8|STANDARD_ERROR_OF_MEAN|1.93||0.68|TWO_SIDED|95.0|-4.58|2.97||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordinal regression models that accounted for repeated measures at both the day- and individual-levels.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6b assessment, which evaluated whether the moderation of insert effects would vary by whether the inserts included pictorial warnings or not. We expected that moderation by baseline delay discounting would be larger for insert only (vs control) than for inserts AND pictorial warnings (vs control) (see Statistical Analysis Plan, Model 5).||2.97|-4.58|0.68
72588599|NCT04075682|144708201|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|-0.23|STANDARD_ERROR_OF_MEAN|0.3||0.45|TWO_SIDED|95.0|-0.81|0.36||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects ordered logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the pre-specified H2 assessment (see Statistical Analysis Plan, Model 1), comparing groups that received pictorial warnings (pictorial warning only AND insert + pictorial warnings) with the groups that did not (insert only AND control). We expected that the outcome would be higher in the pictorial warning groups than in the no pictorial warning groups.||0.36|-0.81|0.45
72588600|NCT04075682|144708201|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|-0.14|STANDARD_ERROR_OF_MEAN|0.25||0.5767|TWO_SIDED|95.0|-0.64|0.7||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects ordered logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results from the multiple imputation model are for the pre-specified H2 assessment (see Statistical Analysis Plan, Model 1), comparing groups that received pictorial warnings (pictorial warning only AND insert + pictorial warnings) with the groups that did not (insert only AND control). We expected that the outcome would be higher in the pictorial warning groups than in the no pictorial warning groups.||0.70|-0.64|0.5767
72588601|NCT04075682|144708202|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|-0.31|STANDARD_ERROR_OF_MEAN|0.34||0.36|TWO_SIDED|95.0|-0.98|0.36||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordered logistic regression models that accounted for repeated measures at the individual level.|We estimated mixed-effects ordered logistic regression models that accounted for repeated measures at the individual level.|These results are for the pre-specified H2 assessment (see Statistical Analysis Plan, Model 1), comparing groups that received pictorial warnings (pictorial warning only AND insert + pictorial warnings) with the groups that did not (insert only AND control). We expected that the outcome would be higher in the pictorial warning groups than in the no pictorial warning groups.||0.36|-0.98|0.36
72588602|NCT04075682|144708202|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|-0.32|STANDARD_ERROR_OF_MEAN|0.67||0.63|TWO_SIDED|95.0|-1.64|0.99||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordered logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H5a assessment, which evaluates moderation of the pre-specified H2 assessment. We expected that the effect of pictorial HWLs (averaged over insert) vs no pictorial HWLs (averaged over insert) on the outcome would be stronger for higher vs lower self-efficacy (see Statistical Analysis Plan, Model 4).||0.99|-1.64|0.63
72588603|NCT04075682|144708202|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|0.25|STANDARD_ERROR_OF_MEAN|0.95||0.79|TWO_SIDED|95.0|-1.62|2.12||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordered logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H5b assessment, which evaluates whether moderation of pictorial warnings effects would vary by whether the pictorial warnings included inserts or not. We expected that moderation effects of baseline self-efficacy would be larger for pictorial warnings only (vs control) than for pictorial warnings AND inserts (vs control) (see Statistical Analysis Plan, Model 4).||2.12|-1.62|0.79
72588604|NCT04075682|144708202|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|-0.23|STANDARD_ERROR_OF_MEAN|0.31||0.4491|TWO_SIDED|95.0|-0.84|0.37||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordered logistic regression models that accounted for repeated measures at the individual level.|We estimated mixed-effects ordered logistic regression models that accounted for repeated measures at the individual level.|These results from the multiple imputation model are for the pre-specified H2 assessment (see Statistical Analysis Plan, Model 1), comparing groups that received pictorial warnings (pictorial warning only AND insert + pictorial warnings) with the groups that did not (insert only AND control). We expected that the outcome would be higher in the pictorial warning groups than in the no pictorial warning groups.||0.37|-0.84|0.4491
72588605|NCT04075682|144708202|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|-0.1|STANDARD_ERROR_OF_MEAN|0.59||0.8713|TWO_SIDED|95.0|-1.26|1.06||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordered logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results from the multiple imputation model are for the intended (but not correctly pre-specified) H5a assessment, which evaluates moderation of the pre-specified H2 assessment. We expected that the effect of pictorial HWLs (averaged over insert) vs no pictorial HWLs (averaged over insert) on the outcome would be stronger for higher vs lower self-efficacy (see Statistical Analysis Plan, Model 4).||1.06|-1.26|0.8713
72588606|NCT04075682|144708202|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|0.85||0.99|TWO_SIDED|95.0|-1.66|1.66||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordered logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results from the multiple imputation model are for the intended (but not correctly pre-specified) H5b assessment, which evaluates whether moderation of pictorial warnings effects would vary by whether the pictorial warnings included inserts or not. We expected that moderation effects of baseline self-efficacy would be larger for pictorial warnings only (vs control) than for pictorial warnings AND inserts (vs control) (see Statistical Analysis Plan, Model 4).||1.66|-1.66|0.99
72588607|NCT04075682|144708203|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|0.69|STANDARD_ERROR_OF_MEAN|0.34||0.04|TWO_SIDED|95.0|0.02|1.37||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordered logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the pre-specified H1 assessment (see Statistical Analysis Plan, Model 1), comparing groups that received inserts (insert only AND insert + pictorial warnings) with the groups that did not (pictorial warning only AND control). We expected that the outcome would be higher in the insert groups than in the no insert groups.||1.37|0.02|0.04
72588608|NCT04075682|144708203|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|-0.87|STANDARD_ERROR_OF_MEAN|0.5||0.08|TWO_SIDED|95.0|-1.85|0.11||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordered logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the pre-specified H3 assessment (see Statistical Analysis Plan, Model 1), comparing the group that received inserts and pictorial warnings with the group that received inserts only. We expected that this outcome would be higher in the insert and pictorial warning group than in the insert only group.||0.11|-1.85|0.08
72588609|NCT04075682|144708203|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|0.23|STANDARD_ERROR_OF_MEAN|0.49||0.65|TWO_SIDED|95.0|-0.74|1.19||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordered logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the pre-specified H4 assessment (see Statistical Analysis Plan, Model 1), comparing the group that received inserts and pictorial warnings with the group that received pictorial warnings only. We expected that this outcome would be higher in the insert and pictorial warning group than in the pictorial warning only group.||1.19|-0.74|0.65
72588610|NCT04075682|144708203|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|0.73|STANDARD_ERROR_OF_MEAN|0.71||0.3|TWO_SIDED|95.0|-0.66|2.11||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordered logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6a assessment, which evaluates moderation of the pre-specified H1 assessment. We expected that the effect of inserts (averaged over pictorial warnings) compared to no inserts (averaged over pictorial warnings) on the outcome would be stronger for those with higher than lower education (see Statistical Analysis Plan, Model 5).||2.11|-0.66|0.30
72414111|NCT01682837|144337180|SUPERIORITY_OR_OTHER|||||||0.18|||||||Mixed Models Analysis|||||||0.18
72414112|NCT01682837|144337181|SUPERIORITY_OR_OTHER|||||||0.12|||||||Mixed Models Analysis|||||||0.12
72552356|NCT04239872|144635462|SUPERIORITY||Mean Difference (Net)|0.3199||||0.0475|TWO_SIDED|95.0|0.004686|0.6351||The threshold for statistical significance was set at p=0.05.|t-test, 2 sided|Paired t-test was used; there were 8 pairs of data, DF=7|Treatment difference of transformed (log10) data = Calcium mouthwash before fluoride mouthwash - Fluoride mouthwash|A paired t-test was used to compare the two groups. To obtain normal distribution, data used in the statistical analysis were transformed to the log10.||0.6351|0.004686|0.0475
72552357|NCT04239872|144635463|SUPERIORITY||Mean Difference (Net)|50.38||||0.0004|TWO_SIDED|95.0|27.46|73.3||The threshold for statistical significance was set at p=0.05.|t-test, 2 sided|Paired t-test was used; there were 13 pairs of data, DF=12|Treatment difference = Calcium mouthwash before fluoride mouthwash - Fluoride mouthwash|A paired t-test was used to compare the two groups.||73.30|27.46|0.0004
72552358|NCT01472341|144635464|SUPERIORITY_OR_OTHER|||||||0.24|TWO_SIDED||||||Multivariate regression analysis|HOMA %B was the response variable and other study parameters were independent variables.||||||0.24
72552359|NCT01472341|144635465|SUPERIORITY_OR_OTHER|||||||0.001|||||||Multivariate regression analysis|PI/I ratio was the response variable and other study parameters were independent variables.||||||0.001
72552360|NCT01472341|144635466|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Multivariate regression analysis|HOMA %B was the response variable and other study parameters were independent variables.||||||<0.0001
72552361|NCT03506386|144635545|OTHER||||||<|0.0001||||||Statistical differences among eligible performed, eligible not performed and not eligible participants were estimated by Log Rank test.|Log Rank|||||||< 0.0001
72552362|NCT01546545|144635606|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|No power calculation was performed. This was the first pilot and feasibility study. This data will be used to power future studies.||||||0.02|||||||t-test, 2 sided|||||||0.02
72552363|NCT01546545|144635607|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|No power calculation was performed. This was a pilot and feasibility study.||||||0.02|||||||t-test, 2 sided|||||||0.02
72552364|NCT00578552|144635611|SUPERIORITY_OR_OTHER|||||||0.77||95.0|||||Fisher Exact|1-tailed||Data were compared between treatment groups using Fisher's exact test for binary outcomes.||||0.77
72552365|NCT00578552|144635611|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|1-tailed||Data were compared between treatment groups using Fisher's exact test for binary outcomes.||||1.00
72552366|NCT00617305|144635633|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-248.93|STANDARD_DEVIATION|241.978|||TWO_SIDED|95.0|-337.7|-160.2||||||Mean change from Baseline to Week 24||-160.2|-337.7|
72552367|NCT00617305|144635633|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-291.8|STANDARD_DEVIATION|205.864|||TWO_SIDED|95.0|-619.4|35.78||||||Mean change from Baseline to Week 24||35.78|-619.4|
72552368|NCT00617305|144635633|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-253.83|STANDARD_DEVIATION|235.787|||TWO_SIDED|95.0|-334.8|-172.8||||||Mean change from Baseline to Week 24||-172.8|-334.8|
72552369|NCT00617305|144635633|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-291.8|STANDARD_DEVIATION|205.864|||TWO_SIDED|95.0|-619.4|35.78||||||Mean change from Baseline to Week 24||35.78|-619.4|
72552370|NCT00617305|144635634|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.38|STANDARD_DEVIATION|7.954|||TWO_SIDED|95.0|-8.29|-2.46||||||Mean change from Baseline to Week 24||-2.46|-8.29|
72552371|NCT00617305|144635634|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-15.75|STANDARD_DEVIATION|8.732|||TWO_SIDED|95.0|-29.64|-1.86||||||Mean change from Baseline to Week 24||-1.86|-29.64|
72552372|NCT00617305|144635634|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-6.56|STANDARD_DEVIATION|8.589|||TWO_SIDED|95.0|-9.51|-3.61||||||Mean change from Baseline to Week 24||-3.61|-9.51|
72552373|NCT00617305|144635634|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-15.75|STANDARD_DEVIATION|8.732|||TWO_SIDED|95.0|-29.64|-1.86||||||Mean change from Baseline to Week 24||-1.86|-29.64|
72552374|NCT00617305|144635635|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.06|STANDARD_DEVIATION|4.442|||TWO_SIDED|95.0|-1.69|1.56||||||Mean change from Baseline to Week 24||1.56|-1.69|
72552375|NCT00617305|144635635|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.0|STANDARD_DEVIATION|4.082|||TWO_SIDED|95.0|-10.5|2.5||||||Mean change from Baseline to Week 24||2.50|-10.50|
72552376|NCT00617305|144635635|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.51|STANDARD_DEVIATION|4.527|||TWO_SIDED|95.0|-2.07|1.04||||||Mean change from Baseline to Week 24||1.04|-2.07|
72552377|NCT00617305|144635635|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.0|STANDARD_DEVIATION|4.082|||TWO_SIDED|95.0|-10.5|2.5||||||Mean change from Baseline to Week 24||2.50|-10.50|
72552378|NCT00617305|144635636|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.84|STANDARD_DEVIATION|1.053|||TWO_SIDED|95.0|0.43|1.25||||||Mean change from Baseline to Week 24||1.25|0.43|
72552379|NCT00617305|144635636|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.33|STANDARD_DEVIATION|0.685|||TWO_SIDED|95.0|-0.77|1.42||||||Mean change from Baseline to Week 24||1.42|-0.77|
72552380|NCT00617305|144635636|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.78|STANDARD_DEVIATION|1.021|||TWO_SIDED|95.0|0.41|1.15||||||Mean change from Baseline to Week 24||1.15|0.41|
72552381|NCT00617305|144635636|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.33|STANDARD_DEVIATION|0.685|||TWO_SIDED|95.0|-0.77|1.42||||||Mean change from Baseline to Week 24||1.42|-0.77|
72552382|NCT00617305|144635637|SUPERIORITY_OR_OTHER||Mean Difference (Net)|12.2|STANDARD_DEVIATION|44.84|||TWO_SIDED|95.0|-3.9|28.4||||||Mean change from Baseline to Week 4 (LOCF)||28.4|-3.9|
72552383|NCT00617305|144635637|SUPERIORITY_OR_OTHER||Mean Difference (Net)|7.8|STANDARD_DEVIATION|21.19|||TWO_SIDED|95.0|-26.0|41.5||||||Mean change from Baseline to Week 4 (LOCF)||41.5|-26.0|
72552384|NCT00617305|144635637|SUPERIORITY_OR_OTHER||Mean Difference (Net)|107.0|STANDARD_DEVIATION|0.0||||||||||||Mean change from Baseline to Week 4 (LOCF)||||
72552385|NCT00617305|144635637|SUPERIORITY_OR_OTHER||Mean Difference (Net)|11.7|STANDARD_DEVIATION|42.68|||TWO_SIDED|95.0|-2.7|26.2||||||Mean change from Baseline to Week 4 (LOCF)||26.2|-2.7|
72552386|NCT00617305|144635637|SUPERIORITY_OR_OTHER||Mean Difference (Net)|27.6|STANDARD_DEVIATION|48.03|||TWO_SIDED|95.0|-32.0|87.2||||||Mean change from Baseline to Week 4 (LOCF)||87.2|-32.0|
72552387|NCT00617305|144635637|SUPERIORITY_OR_OTHER||Mean Difference (Net)|13.6|STANDARD_DEVIATION|41.46|||TWO_SIDED|95.0|-1.4|28.5||||||Mean change from Baseline to Week 12 (LOCF)||28.5|-1.4|
72552388|NCT00617305|144635637|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.5|STANDARD_DEVIATION|59.09|||TWO_SIDED|95.0|-91.5|96.5||||||Mean change from Baseline to Week 12 (LOCF)||96.5|-91.5|
72552389|NCT00617305|144635637|SUPERIORITY_OR_OTHER||Mean Difference (Net)|87.0|STANDARD_DEVIATION|0.0||||||||||||Mean change from Baseline to Week 12 (LOCF)||||
72588611|NCT04075682|144708203|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|-0.21|STANDARD_ERROR_OF_MEAN|0.75||0.78|TWO_SIDED|95.0|-1.68|1.26||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordered logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6a assessment, which evaluates moderation of the pre-specified H1 assessment. We expected that the effect of inserts (averaged over pictorial warnings) compared to no inserts (averaged over pictorial warnings) on the outcome would be stronger for those with higher than lower literacy (see Statistical Analysis Plan, Model 5).||1.26|-1.68|0.78
72588612|NCT04075682|144708203|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|1.48|STANDARD_ERROR_OF_MEAN|0.69||0.03|TWO_SIDED|95.0|0.12|2.83||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordered logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6a assessment, which evaluates moderation of the pre-specified H1 assessment. We expected that the effect of inserts (averaged over pictorial warnings) compared to no inserts (averaged over pictorial warnings) on the outcome would be stronger for those with lower than higher delayed discounting (see Statistical Analysis Plan, Model 5).||2.83|0.12|0.03
72414113|NCT03086447|144337203|OTHER|It was deemed that a total of 135 subjects in the Test group is sufficient to demonstrate statistical acceptance of monocular VA better than equal to 20/40 with a minimum of 90% statistical power using the reference incidence rate of 95% with a correlation of 0.8 between eyes.|Proportion|100.0|||||TWO_SIDED|95.0|96.5|100.0||All primary hypotheses were simultaneously evaluated using a significance level of 0.05 following the intersection-union principal. All primary hypotheses must be met to claim success of the study objectives.|Binomial proportion with Agresti-Coull||All eyes (100%) in the Test group had acceptable VA throughout the study.|Proportion of eyes with overall acceptable VA assessed throughout the study period (up to 4-week) in the Test group was compared to the historical control acceptable rate of 80%. Lower 95% confidence limit was compared to 0.8.||100|96.5|
72588613|NCT04075682|144708203|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|0.06|STANDARD_ERROR_OF_MEAN|1.01||0.95|TWO_SIDED|95.0|-1.92|2.04||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordered logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6b assessment, which evaluated whether the moderation of insert effects would vary by whether the inserts included pictorial warnings or not. We expected that moderation by baseline education would be stronger for insert only (vs control) than for inserts AND pictorial warnings (vs control) (see Statistical Analysis Plan, Model 5).||2.04|-1.92|0.95
72588614|NCT04075682|144708203|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|-0.78|STANDARD_ERROR_OF_MEAN|1.09||0.48|TWO_SIDED|95.0|-2.91|1.36||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordered logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6b assessment, which evaluated whether the moderation of insert effects would vary by whether the inserts included pictorial warnings or not. We expected that moderation by baseline literacy would be larger for insert only (vs control) than for inserts AND pictorial warnings (vs control) (see Statistical Analysis Plan, Model 5).||1.36|-2.91|0.48
72588615|NCT04075682|144708203|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|-0.9|STANDARD_ERROR_OF_MEAN|1.0||0.37|TWO_SIDED|95.0|-2.86|1.07||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordered logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6b assessment, which evaluated whether the moderation of insert effects would vary by whether the inserts included pictorial warnings or not. We expected that moderation by baseline delay discounting would be larger for insert only (vs control) than for inserts AND pictorial warnings (vs control) (see Statistical Analysis Plan, Model 5).||1.07|-2.86|0.37
72588616|NCT04075682|144708203|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|0.73|STANDARD_ERROR_OF_MEAN|0.31||0.0192|TWO_SIDED|95.0|0.12|1.34||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordered logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results from the multiple imputation model are for the pre-specified H1 assessment (see Statistical Analysis Plan, Model 1), comparing groups that received inserts (insert only AND insert + pictorial warnings) with the groups that did not (pictorial warning only AND control). We expected that the outcome would be higher in the insert groups than in the no insert groups.||1.34|0.12|0.0192
72369804|NCT02917642|144249988|SUPERIORITY|||||||0.04|||||||Wilcoxon (Mann-Whitney)|||The null hypothesis is that the irrigation protocol used after the chemo-mechanical preparation does not influence the reduction of bacteria within the root canal system.||||0.04
72369805|NCT02917642|144249989|SUPERIORITY|||||||0.94|||||||Wilcoxon (Mann-Whitney)|||The null hypothesis is that the irrigation protocol used after the chemo-mechanical preparation does not influence the reduction of endotoxin within the root canal system.||||0.94
72369806|NCT02249832|144249990|EQUIVALENCE|A 3x3 repeated measures ANOVA was performed with group (mean gait speed in the low, moderate, and high groups) and time (admission, discharge (week 6), and follow-up (overall week 18) in each condition) as factors. Null hypothesis was that there was no difference in mean gait speed over time across the three groups. A significance level of 0.05 was used (two-sided).|||||<|0.001||||||A significance level of 0.05 was used (two-sided).|ANOVA|||||||<0.001
72588617|NCT04075682|144708203|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|-0.59|STANDARD_ERROR_OF_MEAN|0.45||0.186|TWO_SIDED|95.0|-1.48|0.29||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordered logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are from the multiple imputation model for the pre-specified H3 assessment (see Statistical Analysis Plan, Model 1), comparing the group that received inserts and pictorial warnings with the group that received inserts only. We expected that this outcome would be higher in the insert and pictorial warning group than in the insert only group.||0.29|-1.48|0.1860
72588618|NCT04075682|144708203|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|0.39|STANDARD_ERROR_OF_MEAN|0.44||0.3863|TWO_SIDED|95.0|-0.49|1.26||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordered logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results from the multiple imputation model are for the pre-specified H4 assessment (see Statistical Analysis Plan, Model 1), comparing the group that received inserts and pictorial warnings with the group that received pictorial warnings only. We expected that this outcome would be higher in the insert and pictorial warning group than in the pictorial warning only group.||1.26|-0.49|0.3863
72588619|NCT04075682|144708203|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|0.36|STANDARD_ERROR_OF_MEAN|0.64||0.571|TWO_SIDED|95.0|-0.89|1.61||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordered logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results from the multiple imputation model are for the intended (but not correctly pre-specified) H6a assessment, which evaluates moderation of the pre-specified H1 assessment. We expected that the effect of inserts (averaged over pictorial warnings) compared to no inserts (averaged over pictorial warnings) on the outcome would be stronger for those with higher than lower education (see Statistical Analysis Plan, Model 5).||1.61|-0.89|0.5710
72588620|NCT04075682|144708203|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|-0.73|STANDARD_ERROR_OF_MEAN|0.68||0.2797|TWO_SIDED|95.0|-2.06|0.6||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordered logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results from the multiple imputation model are for the intended (but not correctly pre-specified) H6a assessment, which evaluates moderation of the pre-specified H1 assessment. We expected that the effect of inserts (averaged over pictorial warnings) compared to no inserts (averaged over pictorial warnings) on the outcome would be stronger for those with higher than lower literacy (see Statistical Analysis Plan, Model 5).||0.60|-2.06|0.2797
72552390|NCT00617305|144635637|SUPERIORITY_OR_OTHER||Mean Difference (Net)|12.4|STANDARD_DEVIATION|42.83|||TWO_SIDED|95.0|-2.1|26.9||||||Mean change from Baseline to Week 12 (LOCF)||26.9|-2.1|
72552391|NCT00617305|144635637|SUPERIORITY_OR_OTHER||Mean Difference (Net)|19.4|STANDARD_DEVIATION|63.61|||TWO_SIDED|95.0|-59.6|98.4||||||Mean change from Baseline to Week 12 (LOCF)||98.4|-59.6|
72552392|NCT00617305|144635637|SUPERIORITY_OR_OTHER||Mean Difference (Net)|18.1|STANDARD_DEVIATION|48.67|||TWO_SIDED|95.0|0.5|35.6||||||Mean change from Baseline to Week 24 (LOCF)||35.6|0.5|
72552393|NCT00617305|144635637|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-9.5|STANDARD_DEVIATION|29.56|||TWO_SIDED|95.0|-56.5|37.5||||||Mean change from Baseline to Week 24 (LOCF)||37.5|-56.5|
72552394|NCT00617305|144635637|SUPERIORITY_OR_OTHER||Mean Difference (Net)|87.0|STANDARD_DEVIATION|0.0||||||||||||Mean change from Baseline to Week 24 (LOCF)||||
72552395|NCT00617305|144635637|SUPERIORITY_OR_OTHER||Mean Difference (Net)|15.0|STANDARD_DEVIATION|47.44|||TWO_SIDED|95.0|-1.0|31.1||||||Mean change from Baseline to Week 24 (LOCF)||31.1|-1.0|
72552396|NCT00617305|144635637|SUPERIORITY_OR_OTHER||Mean Difference (Net)|9.8|STANDARD_DEVIATION|50.18|||TWO_SIDED|95.0|-52.5|72.1||||||Mean change from Baseline to Week 24 (LOCF)||72.1|-52.5|
72552397|NCT00617305|144635637|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.2|STANDARD_DEVIATION|77.24|||TWO_SIDED|95.0|-25.6|30.1||||||Mean change from Baseline to Week 36 (LOCF)||30.1|-25.6|
72552398|NCT00617305|144635637|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-34.0|STANDARD_DEVIATION|93.16|||TWO_SIDED|95.0|-182.2|114.2||||||Mean change from Baseline to Week 36 (LOCF)||114.2|-182.2|
72552399|NCT00617305|144635637|SUPERIORITY_OR_OTHER||Mean Difference (Net)|67.0|STANDARD_DEVIATION|0.0||||||||||||Mean change from Baseline to Week 36 (LOCF)||||
72552400|NCT00617305|144635637|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.8|STANDARD_DEVIATION|78.5|||TWO_SIDED|95.0|-28.4|24.8||||||Mean change from Baseline to Week 36 (LOCF)||24.8|-28.4|
72552401|NCT00617305|144635637|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-13.8|STANDARD_DEVIATION|92.46|||TWO_SIDED|95.0|-128.6|101.0||||||Mean change from Baseline to Week 36 (LOCF)||101.0|-128.6|
72552402|NCT00617305|144635637|SUPERIORITY_OR_OTHER||Mean Difference (Net)|14.6|STANDARD_DEVIATION|82.07|||TWO_SIDED|95.0|-15.0|44.2||||||Mean change from Baseline to Week 48 (LOCF)||44.2|-15.0|
72552403|NCT00617305|144635637|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-49.8|STANDARD_DEVIATION|126.75|||TWO_SIDED|95.0|-251.4|151.9||||||Mean change from Baseline to Week 48 (LOCF)||151.9|-251.4|
72552404|NCT00617305|144635637|SUPERIORITY_OR_OTHER||Mean Difference (Net)|67.0|STANDARD_DEVIATION|0.0||||||||||||Mean change from Baseline to Week 48 (LOCF)||||
72552405|NCT00617305|144635637|SUPERIORITY_OR_OTHER||Mean Difference (Net)|7.4|STANDARD_DEVIATION|88.11|||TWO_SIDED|95.0|-22.4|37.3||||||Mean change from Baseline to Week 48 (LOCF)||37.3|-22.4|
72552406|NCT00617305|144635637|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-26.4|STANDARD_DEVIATION|121.55|||TWO_SIDED|95.0|-177.3|124.5||||||Mean change from Baseline to Week 48 (LOCF)||124.5|-177.3|
72552407|NCT00617305|144635638|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.5|STANDARD_DEVIATION|1.5|||TWO_SIDED|95.0|-1.1|0.0||||||Mean change from Baseline to Week 4 (LOCF)||0.0|-1.1|
72552408|NCT00617305|144635638|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.8|STANDARD_DEVIATION|1.5|||TWO_SIDED|95.0|-1.6|3.1||||||Mean change from Baseline to Week 4 (LOCF)||3.1|-1.6|
72552409|NCT00617305|144635638|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.0|STANDARD_DEVIATION|0.0||||||||||||Mean change from Baseline to Week 4 (LOCF)||||
72552410|NCT00617305|144635638|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.4|STANDARD_DEVIATION|1.54|||TWO_SIDED|95.0|-0.9|0.1||||||Mean change from Baseline to Week 4 (LOCF)||0.1|-0.9|
72552411|NCT00617305|144635638|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.4|STANDARD_DEVIATION|1.52|||TWO_SIDED|95.0|-1.5|2.3||||||Mean change from Baseline to Week 4 (LOCF)||2.3|-1.5|
72552412|NCT00617305|144635638|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.6|STANDARD_DEVIATION|1.45|||TWO_SIDED|95.0|-1.1|0.0||||||Mean change from Baseline to Week 12 (LOCF)||0.0|-1.1|
72552413|NCT00617305|144635638|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.5|STANDARD_DEVIATION|2.38|||TWO_SIDED|95.0|-2.3|5.3||||||Mean change from Baseline to Week 12 (LOCF)||5.3|-2.3|
72552414|NCT00617305|144635638|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0|STANDARD_DEVIATION|0.0||||||||||||Mean change from Baseline to Week 12 (LOCF)||||
72552415|NCT00617305|144635638|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.3|STANDARD_DEVIATION|1.67|||TWO_SIDED|95.0|-0.9|0.2||||||Mean change from Baseline to Week 12 (LOCF)||0.2|-0.9|
72552416|NCT00617305|144635638|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.2|STANDARD_DEVIATION|2.17|||TWO_SIDED|95.0|-1.5|3.9||||||Mean change from Baseline to Week 12 (LOCF)||3.9|-1.5|
72552417|NCT00617305|144635638|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.9|STANDARD_DEVIATION|1.81|||TWO_SIDED|95.0|-1.5|-0.2||||||Mean change from Baseline to Week 24 (LOCF)||-0.2|-1.5|
72552418|NCT00617305|144635638|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.6|STANDARD_DEVIATION|0.75|||TWO_SIDED|95.0|-1.8|0.6||||||Mean change from Baseline to Week 24 (LOCF)||0.6|-1.8|
72552419|NCT00617305|144635638|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0|STANDARD_DEVIATION|0.0||||||||||||Mean change from Baseline to Week 24 (LOCF)||||
72552420|NCT00617305|144635638|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.8|STANDARD_DEVIATION|1.72|||TWO_SIDED|95.0|-1.4|-0.3||||||Mean change from Baseline to Week 24 (LOCF)||-0.3|-1.4|
72552421|NCT00617305|144635638|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.5|STANDARD_DEVIATION|0.71|||TWO_SIDED|95.0|-1.4|0.4||||||Mean change from Baseline to Week 24 (LOCF)||0.4|-1.4|
72552422|NCT00617305|144635638|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.6|STANDARD_DEVIATION|1.79|||TWO_SIDED|95.0|-1.2|0.1||||||Mean change from Baseline to Week 36 (LOCF)||0.1|-1.2|
72588621|NCT04075682|144708203|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|1.33|STANDARD_ERROR_OF_MEAN|0.62||0.0312|TWO_SIDED|95.0|0.12|2.55||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordered logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results from the multiple imputation model are for the intended (but not correctly pre-specified) H6a assessment, which evaluates moderation of the pre-specified H1 assessment. We expected that the effect of inserts (averaged over pictorial warnings) compared to no inserts (averaged over pictorial warnings) on the outcome would be stronger for those with lower than higher delayed discounting (see Statistical Analysis Plan, Model 5).||2.55|0.12|0.0312
72552423|NCT00617305|144635638|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.0|STANDARD_DEVIATION|2.0|||TWO_SIDED|95.0|-2.2|4.2||||||Mean change from Baseline to Week 36 (LOCF)||4.2|-2.2|
72552424|NCT00617305|144635638|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0|STANDARD_DEVIATION|0.0||||||||||||Mean change from Baseline to Week 36 (LOCF)||||
72552425|NCT00617305|144635638|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.4|STANDARD_DEVIATION|1.85|||TWO_SIDED|95.0|-1.0|0.2||||||Mean change from Baseline to Week 36 (LOCF)||0.2|-1.0|
72552426|NCT00617305|144635638|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.8|STANDARD_DEVIATION|1.79|||TWO_SIDED|95.0|-1.4|3.0||||||Mean change from Baseline to Week 36 (LOCF)||3.0|-1.4|
72552427|NCT00617305|144635638|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.7|STANDARD_DEVIATION|2.12|||TWO_SIDED|95.0|-1.4|0.1||||||Mean change from Baseline to Week 48 (LOCF)||0.1|-1.4|
72552428|NCT00617305|144635638|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.0|STANDARD_DEVIATION|3.46|||TWO_SIDED|95.0|-4.5|6.5||||||Mean change from Baseline to Week 48 (LOCF)||6.5|-4.5|
72552429|NCT00617305|144635638|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0|STANDARD_DEVIATION|0.0||||||||||||Mean change from Baseline to Week 48 (LOCF)||||
72552430|NCT00617305|144635638|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.5|STANDARD_DEVIATION|2.3|||TWO_SIDED|95.0|-1.3|0.3||||||Mean change from Baseline to Week 48 (LOCF)||0.3|-1.3|
72552431|NCT00617305|144635638|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.8|STANDARD_DEVIATION|3.03|||TWO_SIDED|95.0|-3.0|4.6||||||Mean change from Baseline to Week 48 (LOCF)||4.6|-3.0|
72552432|NCT00617305|144635639|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.1|STANDARD_DEVIATION|3.98|||TWO_SIDED|95.0|-2.7|0.4||||||Mean change from Baseline to Week 12 (LOCF)||0.4|-2.7|
72552433|NCT00617305|144635639|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.3|STANDARD_DEVIATION|4.86|||TWO_SIDED|95.0|-6.5|9.0||||||Mean change from Baseline to Week 12 (LOCF)||9.0|-6.5|
72552434|NCT00617305|144635639|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.0|STANDARD_DEVIATION|0.0||||||||||||Mean change from Baseline to Week 12 (LOCF)||||
72552435|NCT00617305|144635639|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.8|STANDARD_DEVIATION|4.09|||TWO_SIDED|95.0|-2.3|0.6||||||Mean change from Baseline to Week 12 (LOCF)||0.6|-2.3|
72552436|NCT00617305|144635639|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.6|STANDARD_DEVIATION|4.45|||TWO_SIDED|95.0|-4.9|6.1||||||Mean change from Baseline to Week 12 (LOCF)||6.1|-4.9|
72552437|NCT00617305|144635639|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.8|STANDARD_DEVIATION|5.0|||TWO_SIDED|95.0|-2.7|1.1||||||Mean change from Baseline to Week 24 (LOCF)||1.1|-2.7|
72552438|NCT00617305|144635639|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.3|STANDARD_DEVIATION|4.03|||TWO_SIDED|95.0|-7.7|5.2||||||Mean change from Baseline to Week 24 (LOCF)||5.2|-7.7|
72552439|NCT00617305|144635639|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.0|STANDARD_DEVIATION|0.0||||||||||||Mean change from Baseline to Week 24 (LOCF)||||
72552440|NCT00617305|144635639|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.9|STANDARD_DEVIATION|4.84|||TWO_SIDED|95.0|-2.6|0.9||||||Mean change from Baseline to Week 24 (LOCF)||0.9|-2.6|
72552441|NCT00617305|144635639|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.4|STANDARD_DEVIATION|3.51|||TWO_SIDED|95.0|-5.8|3.0||||||Mean change from Baseline to Week 24 (LOCF)||3.0|-5.8|
72552442|NCT00617305|144635639|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.3|STANDARD_DEVIATION|5.2|||TWO_SIDED|95.0|-2.3|1.7||||||Mean change from Baseline to Week 36 (LOCF)||1.7|-2.3|
72552443|NCT00617305|144635639|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.8|STANDARD_DEVIATION|4.65|||TWO_SIDED|95.0|-8.1|6.6||||||Mean change from Baseline to Week 36 (LOCF)||6.6|-8.1|
72552444|NCT00617305|144635639|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.0|STANDARD_DEVIATION|0.0||||||||||||Mean change from Baseline to Week 36 (LOCF)||||
72552445|NCT00617305|144635639|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.3|STANDARD_DEVIATION|5.07|||TWO_SIDED|95.0|-2.2|1.5||||||Mean change from Baseline to Week 36 (LOCF)||1.5|-2.2|
72552446|NCT00617305|144635639|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.8|STANDARD_DEVIATION|4.02|||TWO_SIDED|95.0|-5.8|4.2||||||Mean change from Baseline to Week 36 (LOCF)||4.2|-5.8|
72552447|NCT00617305|144635639|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.4|STANDARD_DEVIATION|6.33|||TWO_SIDED|95.0|-2.8|2.1||||||Mean change from Baseline to Week 48 (LOCF)||2.1|-2.8|
72552448|NCT00617305|144635639|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.5|STANDARD_DEVIATION|6.86|||TWO_SIDED|95.0|-11.4|10.4||||||Mean change from Baseline to Week 48 (LOCF)||10.4|-11.4|
72552449|NCT00617305|144635639|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.0|STANDARD_DEVIATION|0.0||||||||||||Mean change from Baseline to Week 48 (LOCF)||||
72552450|NCT00617305|144635639|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.4|STANDARD_DEVIATION|6.28|||TWO_SIDED|95.0|-2.7|1.9||||||Mean change from Baseline to Week 48 (LOCF)||1.9|-2.7|
72552451|NCT00617305|144635639|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.6|STANDARD_DEVIATION|5.94|||TWO_SIDED|95.0|-8.0|6.8||||||Mean change from Baseline to Week 48 (LOCF)||6.8|-8.0|
72552452|NCT00617305|144635641|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.4|STANDARD_DEVIATION|0.5||||||||||||Mean change from Baseline to Week 4 (LOCF)||||
72552453|NCT00617305|144635641|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.2|STANDARD_DEVIATION|0.28||||||||||||Mean change from Baseline to Week 4 (LOCF)||||
72414114|NCT03086447|144337204|OTHER|It was deemed that a total of 135 subjects in the Test group is sufficient to demonstrate statistical acceptance of lens fit with a minimum of 90% statistical power using the reference incidence rate of 95% with a correlation of 0.8 between eyes.|Proportion|100.0|||||TWO_SIDED|95.0|96.5|100.0||All primary hypotheses were simultaneously evaluated using a significance level of 0.05 following the intersection-union principal. All primary hypotheses must be met to claim success of the study objectives.|Binomial proportion with Agrestic-Coull||All eyes (100%) in the Test group had acceptable lens fit at fitting (visit 1).|Proportion of eyes with acceptable lens fit assessed at fitting (visit 1) in the Test group was compared to the historical control rate of 80%. Lower 95% confidence limit was compared to 0.8.||100.0|96.5|
72552454|NCT00617305|144635641|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.4|STANDARD_DEVIATION|0.49||||||||||||Mean change from Baseline to Week 4 (LOCF)||||
72552455|NCT00617305|144635641|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.2|STANDARD_DEVIATION|0.28||||||||||||Mean change from Baseline to Week 4 (LOCF)||||
72552456|NCT00617305|144635641|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.3|STANDARD_DEVIATION|0.63||||||||||||Mean change from Baseline to Week 12 (LOCF)||||
72588622|NCT04075682|144708203|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|0.6|STANDARD_ERROR_OF_MEAN|0.91||0.5086|TWO_SIDED|95.0|-1.19|2.39||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordered logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results from the multiple imputation model are for the intended (but not correctly pre-specified) H6b assessment, which evaluated whether the moderation of insert effects would vary by whether the inserts included pictorial warnings or not. We expected that moderation by baseline education would be stronger for insert only (vs control) than for inserts AND pictorial warnings (vs control) (see Statistical Analysis Plan, Model 5).||2.39|-1.19|0.5086
72588623|NCT04075682|144708203|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|0.06|STANDARD_ERROR_OF_MEAN|0.98||0.9474|TWO_SIDED|95.0|-1.86|1.99||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordered logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are from the multiple imputation model for the intended (but not correctly pre-specified) H6b assessment, which evaluated whether the moderation of insert effects would vary by whether the inserts included pictorial warnings or not. We expected that moderation by baseline literacy would be larger for insert only (vs control) than for inserts AND pictorial warnings (vs control) (see Statistical Analysis Plan, Model 5).||1.99|-1.86|0.9474
72588624|NCT04075682|144708203|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|-0.6|STANDARD_ERROR_OF_MEAN|0.9||0.5018|TWO_SIDED|95.0|-2.36|1.16||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordered logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results from the multiple imputation model are for the intended (but not correctly pre-specified) H6b assessment, which evaluated whether the moderation of insert effects would vary by whether the inserts included pictorial warnings or not. We expected that moderation by baseline delay discounting would be larger for insert only (vs control) than for inserts AND pictorial warnings (vs control) (see Statistical Analysis Plan, Model 5).||1.16|-2.36|0.5018
72588625|NCT04075682|144708204|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|0.45|STANDARD_ERROR_OF_MEAN|0.39||0.25|TWO_SIDED|95.0|-0.31|1.21||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordered logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the pre-specified H1 assessment (see Statistical Analysis Plan, Model 1), comparing groups that received inserts (insert only AND insert + pictorial warnings) with the groups that did not (pictorial warning only AND control). We expected that the outcome would be higher in the insert groups than in the no insert groups.||1.21|-0.31|0.25
72588626|NCT04075682|144708204|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|-0.53|STANDARD_ERROR_OF_MEAN|0.56||0.34|TWO_SIDED|95.0|-1.63|0.57||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordered logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the pre-specified H3 assessment (see Statistical Analysis Plan, Model 1), comparing the group that received inserts and pictorial warnings with the group that received inserts only. We expected that this outcome would be higher in the insert and pictorial warning group than in the insert only group.||0.57|-1.63|0.34
72588627|NCT04075682|144708204|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|-0.17|STANDARD_ERROR_OF_MEAN|0.56||0.76|TWO_SIDED|95.0|-1.26|0.92||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordered logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the pre-specified H4 assessment (see Statistical Analysis Plan, Model 1), comparing the group that received inserts and pictorial warnings with the group that received pictorial warnings only. We expected that this outcome would be higher in the insert and pictorial warning group than in the pictorial warning only group.||0.92|-1.26|0.76
72588628|NCT04075682|144708204|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|1.1|STANDARD_ERROR_OF_MEAN|0.78||0.15|TWO_SIDED|95.0|-0.42|2.63||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordered logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6a assessment, which evaluates moderation of the pre-specified H1 assessment. We expected that the effect of inserts (averaged over pictorial warnings) compared to no inserts (averaged over pictorial warnings) on the outcome would be stronger for those with higher than lower education (see Statistical Analysis Plan, Model 5).||2.63|-0.42|0.15
72588629|NCT04075682|144708204|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|-0.003|STANDARD_ERROR_OF_MEAN|0.85||1|TWO_SIDED|95.0|-1.66|1.66||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordered logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6a assessment, which evaluates moderation of the pre-specified H1 assessment. We expected that the effect of inserts (averaged over pictorial warnings) compared to no inserts (averaged over pictorial warnings) on the outcome would be stronger for those with higher than lower literacy (see Statistical Analysis Plan, Model 5).||1.66|-1.66|1.00
72588630|NCT04075682|144708204|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|1.9|STANDARD_ERROR_OF_MEAN|0.78||0.01|TWO_SIDED|95.0|0.38|3.43||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordered logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6a assessment, which evaluates moderation of the pre-specified H1 assessment. We expected that the effect of inserts (averaged over pictorial warnings) compared to no inserts (averaged over pictorial warnings) on the outcome would be stronger for those with lower than higher delayed discounting (see Statistical Analysis Plan, Model 5).||3.43|0.38|0.01
72588631|NCT04075682|144708204|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|0.62|STANDARD_ERROR_OF_MEAN|1.11||0.58|TWO_SIDED|95.0|-1.56|2.8||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordered logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6b assessment, which evaluated whether the moderation of insert effects would vary by whether the inserts included pictorial warnings or not. We expected that moderation by baseline education would be stronger for insert only (vs control) than for inserts AND pictorial warnings (vs control) (see Statistical Analysis Plan, Model 5).||2.80|-1.56|0.58
72588632|NCT04075682|144708204|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|-1.06|STANDARD_ERROR_OF_MEAN|1.23||0.39|TWO_SIDED|95.0|-3.47|1.35||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordered logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6b assessment, which evaluated whether the moderation of insert effects would vary by whether the inserts included pictorial warnings or not. We expected that moderation by baseline literacy would be larger for insert only (vs control) than for inserts AND pictorial warnings (vs control) (see Statistical Analysis Plan, Model 5).||1.35|-3.47|0.39
72588633|NCT04075682|144708204|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|-0.85|STANDARD_ERROR_OF_MEAN|1.12||0.45|TWO_SIDED|95.0|-3.05|1.35||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordered logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6b assessment, which evaluated whether the moderation of insert effects would vary by whether the inserts included pictorial warnings or not. We expected that moderation by baseline delay discounting would be larger for insert only (vs control) than for inserts AND pictorial warnings (vs control) (see Statistical Analysis Plan, Model 5).||1.35|-3.05|0.45
72588634|NCT04075682|144708204|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|0.54|STANDARD_ERROR_OF_MEAN|0.34||0.1147|TWO_SIDED|95.0|-0.13|1.21||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordered logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results from the multiple imputation model are for the pre-specified H1 assessment (see Statistical Analysis Plan, Model 1), comparing groups that received inserts (insert only AND insert + pictorial warnings) with the groups that did not (pictorial warning only AND control). We expected that the outcome would be higher in the insert groups than in the no insert groups.||1.21|-0.13|0.1147
72588635|NCT04075682|144708204|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|-0.44|STANDARD_ERROR_OF_MEAN|0.49||0.3721|TWO_SIDED|95.0|-1.41|0.53||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordered logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results from the multiple imputation model are for the pre-specified H3 assessment (see Statistical Analysis Plan, Model 1), comparing the group that received inserts and pictorial warnings with the group that received inserts only. We expected that this outcome would be higher in the insert and pictorial warning group than in the insert only group.||0.53|-1.41|0.3721
72588636|NCT04075682|144708204|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|0.07|STANDARD_ERROR_OF_MEAN|0.49||0.8827|TWO_SIDED|95.0|-0.89|1.03||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordered logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are from the multiple imputation model for the pre-specified H4 assessment (see Statistical Analysis Plan, Model 1), comparing the group that received inserts and pictorial warnings with the group that received pictorial warnings only. We expected that this outcome would be higher in the insert and pictorial warning group than in the pictorial warning only group.||1.03|-0.89|0.8827
72588637|NCT04075682|144708204|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|0.54|STANDARD_ERROR_OF_MEAN|0.68||0.4335|TWO_SIDED|95.0|-0.8|1.87||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordered logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results from the multiple imputation model are for the intended (but not correctly pre-specified) H6a assessment, which evaluates moderation of the pre-specified H1 assessment. We expected that the effect of inserts (averaged over pictorial warnings) compared to no inserts (averaged over pictorial warnings) on the outcome would be stronger for those with higher than lower education (see Statistical Analysis Plan, Model 5).||1.87|-0.80|0.4335
72588638|NCT04075682|144708204|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|-0.62|STANDARD_ERROR_OF_MEAN|0.74||0.4063|TWO_SIDED|95.0|-2.07|0.84||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordered logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are from the multiple imputation model for the intended (but not correctly pre-specified) H6a assessment, which evaluates moderation of the pre-specified H1 assessment. We expected that the effect of inserts (averaged over pictorial warnings) compared to no inserts (averaged over pictorial warnings) on the outcome would be stronger for those with higher than lower literacy (see Statistical Analysis Plan, Model 5).||0.84|-2.07|0.4063
72588639|NCT04075682|144708204|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|1.69|STANDARD_ERROR_OF_MEAN|0.68||0.0132|TWO_SIDED|95.0|0.35|3.03||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordered logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results from the multiple imputation model are for the intended (but not correctly pre-specified) H6a assessment, which evaluates moderation of the pre-specified H1 assessment. We expected that the effect of inserts (averaged over pictorial warnings) compared to no inserts (averaged over pictorial warnings) on the outcome would be stronger for those with lower than higher delayed discounting (see Statistical Analysis Plan, Model 5).||3.03|0.35|0.0132
72588640|NCT04075682|144708204|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|0.83|STANDARD_ERROR_OF_MEAN|0.98||0.3949|TWO_SIDED|95.0|-1.08|2.75||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordered logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results from the multiple imputation model are for the intended (but not correctly pre-specified) H6b assessment, which evaluated whether the moderation of insert effects would vary by whether the inserts included pictorial warnings or not. We expected that moderation by baseline education would be stronger for insert only (vs control) than for inserts AND pictorial warnings (vs control) (see Statistical Analysis Plan, Model 5).||2.75|-1.08|0.3949
72552457|NCT00617305|144635641|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1|STANDARD_DEVIATION|1.07||||||||||||Mean change from Baseline to Week 12 (LOCF)||||
72552458|NCT00617305|144635641|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.3|STANDARD_DEVIATION|0.64||||||||||||Mean change from Baseline to Week 12 (LOCF)||||
72552459|NCT00617305|144635641|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1|STANDARD_DEVIATION|1.07||||||||||||Mean change from Baseline to Week 12 (LOCF)||||
72552460|NCT00617305|144635641|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.4|STANDARD_DEVIATION|0.83||||||||||||Mean change from Baseline to Week 24 (LOCF)||||
72552461|NCT00617305|144635641|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.7|STANDARD_DEVIATION|0.34||||||||||||Mean change from Baseline to Week 24 (LOCF)||||
72552462|NCT00617305|144635641|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.4|STANDARD_DEVIATION|0.81||||||||||||Mean change from Baseline to Week 24 (LOCF)||||
72552463|NCT00617305|144635641|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.7|STANDARD_DEVIATION|0.34||||||||||||Mean change from Baseline to Week 24 (LOCF)||||
72552464|NCT00617305|144635641|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.4|STANDARD_DEVIATION|0.92||||||||||||Mean change from Baseline to Week 36 (LOCF)||||
72552465|NCT00617305|144635641|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.8|STANDARD_DEVIATION|0.9||||||||||||Mean change from Baseline to Week 36 (LOCF)||||
72552466|NCT00617305|144635641|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.4|STANDARD_DEVIATION|0.91||||||||||||Mean change from Baseline to Week 36 (LOCF)||||
72552467|NCT00617305|144635641|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.8|STANDARD_DEVIATION|0.9||||||||||||Mean change from Baseline to Week 36 (LOCF)||||
72552468|NCT00617305|144635641|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.4|STANDARD_DEVIATION|0.91||||||||||||Mean change from Baseline to Week 48 (LOCF)||||
72552469|NCT00617305|144635641|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.3|STANDARD_DEVIATION|0.77||||||||||||Mean change from Baseline to Week 48 (LOCF)||||
72552470|NCT00617305|144635641|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.4|STANDARD_DEVIATION|0.88||||||||||||Mean change from Baseline to Week 48 (LOCF)||||
72552471|NCT00617305|144635641|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.3|STANDARD_DEVIATION|0.77||||||||||||Mean change from Baseline to Week 48 (LOCF)||||
72552472|NCT03555305|144635647|EQUIVALENCE|Analysis was performed using linear mixed effects model and participant as a random effect, with period, sequence, and treatment as fixed effects. The estimate of the ratio of means of each PK/PD parameters between the 2 treatments and the corresponding 90% confidence interval were calculated. A typical bio-equivalence limit (0.8 to 1.25) was used as equivalence margin.|Ratio of geometric least squares means|0.961|||||TWO_SIDED|90.0|0.886|1.04|||Linear mixed-effects model|||||1.04|0.886|
72552473|NCT03555305|144635648|EQUIVALENCE|Analysis was performed using linear mixed effects model and participant as a random effect, with period, sequence, and treatment as fixed effects. The estimate of the ratio of means of each PK/PD parameters between the 2 treatments and the corresponding 90% confidence interval were calculated. A typical bio-equivalence limit (0.8 to 1.25) was used as equivalence margin.|Ratio of geometric least squares means|0.943|||||TWO_SIDED|90.0|0.874|1.02|||Linear mixed-effects model|||||1.02|0.874|
72552474|NCT00323193|144635665|SUPERIORITY_OR_OTHER|||||||0.72|TWO_SIDED||||||ANOVA|||||||.720
72552475|NCT00323193|144635666|SUPERIORITY_OR_OTHER|||||||0.71|TWO_SIDED||||||ANOVA|||||||.710
72552476|NCT02100228|144635667|SUPERIORITY|This was a descriptive study, and there was no formal pre-defined hypothesis testing.|Risk Ratio (RR)|0.0||||0.0151|TWO_SIDED|95.0|0.0|0.6425||nominal p-value|Fisher Exact|||Display exact confidence limits for relative risk and Fisher's exact test for comparisons of two proportions.||0.6425|0.0000|0.0151
72552477|NCT02100228|144635669|SUPERIORITY|This was a descriptive study, and there was no formal pre-defined hypothesis testing.|Risk Ratio (RR)|0.4905||||0.3378|TWO_SIDED|95.0|0.1046|2.0678||nominal p-value|Fisher Exact|||Display exact confidence limits for relative risk and Fisher's exact test for comparisons of two proportions.||2.0678|0.1046|0.3378
72552478|NCT02100228|144635670|SUPERIORITY|This was a descriptive study, and there was no formal pre-defined hypothesis testing.|Risk Ratio (RR)|0.83||||0.6851|TWO_SIDED|95.0|0.3433|1.8916||nominal p-value|Fisher Exact|||Display exact confidence limits for relative risk and Fisher's exact test for comparisons of two proportions.||1.8916|0.3433|0.6851
72588641|NCT04075682|144708204|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|-0.39|STANDARD_ERROR_OF_MEAN|1.08||0.7145|TWO_SIDED|95.0|-2.5|1.72||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordered logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results from the multiple imputation model are for the intended (but not correctly pre-specified) H6b assessment, which evaluated whether the moderation of insert effects would vary by whether the inserts included pictorial warnings or not. We expected that moderation by baseline literacy would be larger for insert only (vs control) than for inserts AND pictorial warnings (vs control) (see Statistical Analysis Plan, Model 5).||1.72|-2.50|0.7145
72588642|NCT04075682|144708204|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|-0.51|STANDARD_ERROR_OF_MEAN|0.98||0.6081|TWO_SIDED|95.0||||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordered logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results from the multiple imputation model are for the intended (but not correctly pre-specified) H6b assessment, which evaluated whether the moderation of insert effects would vary by whether the inserts included pictorial warnings or not. We expected that moderation by baseline delay discounting would be larger for insert only (vs control) than for inserts AND pictorial warnings (vs control) (see Statistical Analysis Plan, Model 5).||||0.6081
72588643|NCT04075682|144708205|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|-0.26|STANDARD_ERROR_OF_MEAN|0.46||0.58|TWO_SIDED|95.0|-1.15|0.64||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordered logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the pre-specified H2 assessment (see Statistical Analysis Plan, Model 1), comparing groups that received pictorial warnings (pictorial warning only AND insert + pictorial warnings) with the groups that did not (insert only AND control). We expected that the outcome would be higher in the pictorial warning groups than in the no pictorial warning groups.||0.64|-1.15|0.58
72588644|NCT04075682|144708205|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|-0.2|STANDARD_ERROR_OF_MEAN|0.9||0.82|TWO_SIDED|95.0|-1.98|1.57||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordered logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H5a assessment, which evaluates moderation of the pre-specified H2 assessment. We expected that the effect of pictorial HWLs (averaged over insert) vs no pictorial HWLs (averaged over insert) on the outcome would be stronger for higher vs lower self-efficacy (see Statistical Analysis Plan, Model 4)||1.57|-1.98|0.82
72588645|NCT04075682|144708205|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|1.67|STANDARD_ERROR_OF_MEAN|1.31||0.2|TWO_SIDED|95.0|-0.9|4.24||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordered logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H5b assessment, which evaluates whether moderation of pictorial warnings effects would vary by whether the pictorial warnings included inserts or not. We expected that moderation effects of baseline self-efficacy would be larger for pictorial warnings only (vs control) than for pictorial warnings AND inserts (vs control) (see Statistical Analysis Plan, Model 4).||4.24|-0.90|0.20
72588646|NCT04075682|144708205|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|-0.05|STANDARD_ERROR_OF_MEAN|0.36||0.88|TWO_SIDED|95.0|-0.77|0.66||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordered logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results from the multiple imputation analysis are for the pre-specified H2 assessment (see Statistical Analysis Plan, Model 1), comparing groups that received pictorial warnings (pictorial warning only AND insert + pictorial warnings) with the groups that did not (insert only AND control). We expected that the outcome would be higher in the pictorial warning groups than in the no pictorial warning groups.||0.66|-0.77|0.8800
72588647|NCT04075682|144708205|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Median Difference (Net)|0.1|STANDARD_ERROR_OF_MEAN|0.72||0.8864|TWO_SIDED|95.0|-1.3|1.5||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordered logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results from the multiple imputation model are for the intended (but not correctly pre-specified) H5a assessment, which evaluates moderation of the pre-specified H2 assessment. We expected that the effect of pictorial HWLs (averaged over insert) vs no pictorial HWLs (averaged over insert) on the outcome would be stronger for higher vs lower self-efficacy (see Statistical Analysis Plan, Model 4)||1.50|-1.30|0.8864
72588648|NCT04075682|144708205|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|1.12|STANDARD_ERROR_OF_MEAN|1.02||0.2748|TWO_SIDED|95.0|-0.89|3.12||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordered logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results from the multiple imputation model are for the intended (but not correctly pre-specified) H5b assessment, which evaluates whether moderation of pictorial warnings effects would vary by whether the pictorial warnings included inserts or not. We expected that moderation effects of baseline self-efficacy would be larger for pictorial warnings only (vs control) than for pictorial warnings AND inserts (vs control) (see Statistical Analysis Plan, Model 4).||3.12|-0.89|0.2748
72588649|NCT04075682|144708206|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|1.1|STANDARD_ERROR_OF_MEAN|0.5||0.83|TWO_SIDED|95.0|0.45|2.7||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the pre-specified H1 assessment (see Statistical Analysis Plan, Model 1), comparing groups that received inserts (insert only AND insert + pictorial warnings) with the groups that did not (pictorial warning only AND control). We expected that the outcome would be lower in the insert groups than in the no insert groups.||2.70|0.45|0.83
72588650|NCT04075682|144708206|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|2.86|STANDARD_ERROR_OF_MEAN|1.34||0.03|TWO_SIDED|95.0|1.14|7.18||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the pre-specified H2 assessment (see Statistical Analysis Plan, Model 1), comparing groups that received pictorial warnings (pictorial warning only AND insert + pictorial warnings) with the groups that did not (insert only AND control). We expected that the outcome would be higher in the pictorial warning groups than in the no pictorial warning groups.||7.18|1.14|0.03
72588651|NCT04075682|144708206|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|0.53|STANDARD_ERROR_OF_MEAN|0.27||0.18|TWO_SIDED|95.0|0.15|1.44||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the pre-specified H4 assessment (see Statistical Analysis Plan, Model 1), comparing the group that received inserts and pictorial warnings with the group that received pictorial warnings only. We expected that this outcome would be lower in the insert and pictorial warning group than in the pictorial warning only group.||1.44|0.15|0.18
72588652|NCT04075682|144708206|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|1.01|STANDARD_ERROR_OF_MEAN|1.3||0.99|TWO_SIDED|95.0|0.08|12.57||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H5a assessment, which evaluates moderation of the pre-specified H2 assessment. We expected that the effect of pictorial HWLs (averaged over insert) vs no pictorial HWLs (averaged over insert) on the outcome would be lower for higher vs lower self-efficacy (see Statistical Analysis Plan, Model 4).||12.57|0.08|0.99
72588653|NCT04075682|144708206|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|0.9|STANDARD_ERROR_OF_MEAN|0.52||0.86|TWO_SIDED|95.0|0.29|2.82||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.||These results are for the intended (but not correctly pre-specified) H5b assessment, which evaluates whether moderation of pictorial warnings effects would vary by whether the pictorial warnings included inserts or not. We expected that moderation effects of baseline self-efficacy would be larger for pictorial warnings only (vs control) than for pictorial warnings AND inserts (vs control) (see Statistical Analysis Plan, Model 4).||2.82|0.29|0.86
72588654|NCT04075682|144708206|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|1.1|STANDARD_ERROR_OF_MEAN|0.43||0.8045|TWO_SIDED|||||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results from the multiple imputation model are for the pre-specified H1 assessment (see Statistical Analysis Plan, Model 1), comparing groups that received inserts (insert only AND insert + pictorial warnings) with the groups that did not (pictorial warning only AND control). We expected that the outcome would be lower in the insert groups than in the no insert groups.||||0.8045
72552479|NCT02100228|144635671|SUPERIORITY|This was a descriptive study, and there was no formal pre-defined hypothesis testing.|Risk Ratio (RR)|1.9841|||>|0.9999|TWO_SIDED|95.0|0.1866|53.9968||nominal p-value|Fisher Exact|||Display exact confidence limits for relative risk and Fisher's exact test for comparisons of two proportions.||53.9968|0.1866|>0.9999
72552480|NCT01073657|144635694|SUPERIORITY_OR_OTHER||Mean Difference (Net)|18.0|STANDARD_DEVIATION|33.9||0.0059|TWO_SIDED|95.0|14.0|38.0|||t-test, 2 sided|||||38|14|0.0059
72552481|NCT00854100|144635695|SUPERIORITY||Least Squares Mean Difference|0.5||||0.746|TWO_SIDED|95.0|-2.4|3.4|||ANCOVA|||||3.4|-2.4|0.746
72552482|NCT00854100|144635695|SUPERIORITY||Least Squares Mean Difference|-1.8||||0.227|TWO_SIDED|95.0|-4.8|1.1|||ANCOVA|||||1.1|-4.8|0.227
72552483|NCT00854100|144635696|SUPERIORITY||Least Squares Mean Difference|0.0||||0.918|TWO_SIDED|95.0|-0.3|0.3|||ANCOVA|||||0.3|-0.3|0.918
72552484|NCT00854100|144635696|SUPERIORITY||Least Squares Mean Difference|-0.2||||0.167|TWO_SIDED|95.0|-0.6|0.1|||ANCOVA|||||0.1|-0.6|0.167
72552485|NCT00762307|144635739|OTHER||Mean Difference (Net)|18.7|STANDARD_ERROR_OF_MEAN|1.9|||TWO_SIDED|95.0|14.9|22.4||||||||22.4|14.9|
72552486|NCT00762307|144635741|OTHER||sucess percentage|91.9|STANDARD_ERROR_OF_MEAN|5.2|||ONE_SIDED|||||||||||||
72552487|NCT00840632|144635767|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of Least Squares Means|93.26||||||90.0|83.39|104.31|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||104.31|83.39|
72552488|NCT00840632|144635768|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of Least Squares Means|100.35||||||90.0|92.08|109.36|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||109.36|92.08|
72552489|NCT00840632|144635769|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of Least Squares Means|99.17||||||90.0|92.71|106.08|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||106.08|92.71|
72552490|NCT00840632|144635770|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of Least Squares Means|102.93||||||90.0|99.8|106.15|||||Informational Purposes Only|||106.15|99.80|
72552491|NCT00840632|144635771|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of Least Squares Means|100.24||||||90.0|98.11|102.43|||||Informational Purposes Only|||102.43|98.11|
72552492|NCT00840632|144635772|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of Least Squares Means|100.1||||||90.0|98.12|102.12|||||Informational Purposes Only|||102.12|98.12|
72552493|NCT01811953|144635826|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMean), test/reference, for the primary endpoints using an acceptance range of 80.00 to 125.00%.|Geometric mean ratio|102.55|STANDARD_ERROR_OF_MEAN|1.017|<|0.0001|TWO_SIDED|90.0|99.531|105.653|||ANOVA||The geometric mean ratio was calculated as the geometric mean of '1 Empagliflozin/Metformin (T)' divided by the geometric mean of '3 Empagliflozin + Metformin (R)'.|||105.653|99.531|<0.0001
72552494|NCT01811953|144635826|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMean), test/reference, for the primary endpoints using an acceptance range of 80.00 to 125.00%.|Geometric mean ratio|98.88|STANDARD_ERROR_OF_MEAN|1.024|<|0.0001|TWO_SIDED|90.0|94.879|103.059|||ANOVA||The geometric mean ratio was calculated as the geometric mean of '2 Empagliflozin/Metformin (T)' divided by the geometric mean of '4 Empagliflozin + Metformin (R)'.|||103.059|94.879|<0.0001
72552495|NCT01811953|144635826|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMean), test/reference, for the primary endpoints using an acceptance range of 80.00 to 125.00%.|Geometric mean ratio|106.0|STANDARD_ERROR_OF_MEAN|1.018|<|0.0001|TWO_SIDED|90.0|102.728|109.386|||ANOVA||The geometric mean ratio was calculated as the geometric mean of '5 Empagliflozin/Metformin (T)' divided by the geometric mean of '6 Empagliflozin + Metformin (R)'.|||109.386|102.728|<0.0001
72552496|NCT01811953|144635827|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMean), test/reference, for the primary endpoints using an acceptance range of 80.00 to 125.00%.|Geometric mean ratio|96.13|STANDARD_ERROR_OF_MEAN|1.03|<|0.0001|TWO_SIDED|90.0|91.25|101.26|||ANOVA||The geometric mean ratio was calculated as the geometric mean of '1 Empagliflozin/Metformin (T)' divided by the geometric mean of '3 Empagliflozin + Metformin (R)'.|||101.26|91.25|<0.0001
72552497|NCT01811953|144635827|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMean), test/reference, for the primary endpoints using an acceptance range of 80.00 to 125.00%.|Geometric mean ratio|99.34|STANDARD_ERROR_OF_MEAN|1.04|<|0.0001|TWO_SIDED|90.0|92.56|106.62|||ANOVA||The geometric mean ratio was calculated as the geometric mean of '2 Empagliflozin/Metformin (T)' divided by the geometric mean of '4 Empagliflozin + Metformin (R)'.|||106.62|92.56|<0.0001
72588655|NCT04075682|144708206|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|2.53|STANDARD_ERROR_OF_MEAN|1.01||0.0205|TWO_SIDED|||||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are from the multiple imputation model for the pre-specified H2 assessment (see Statistical Analysis Plan, Model 1), comparing groups that received pictorial warnings (pictorial warning only AND insert + pictorial warnings) with the groups that did not (insert only AND control). We expected that the outcome would be higher in the pictorial warning groups than in the no pictorial warning groups.||||0.0205
72588656|NCT04075682|144708206|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|0.53|STANDARD_ERROR_OF_MEAN|0.26||0.1918|TWO_SIDED|||||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results from the multiple imputation model are for the pre-specified H4 assessment (see Statistical Analysis Plan, Model 1), comparing the group that received inserts and pictorial warnings with the group that received pictorial warnings only. We expected that this outcome would be lower in the insert and pictorial warning group than in the pictorial warning only group.||||0.1918
72588657|NCT04075682|144708206|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|1.03|STANDARD_ERROR_OF_MEAN|1.12||0.99|TWO_SIDED|||||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are from the multiple imputation model for the intended (but not correctly pre-specified) H5a assessment, which evaluates moderation of the pre-specified H2 assessment. We expected that the effect of pictorial HWLs (averaged over insert) vs no pictorial HWLs (averaged over insert) on the outcome would be lower for higher vs lower self-efficacy (see Statistical Analysis Plan, Model 4).||||0.99
72588658|NCT04075682|144708206|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|1.56|STANDARD_ERROR_OF_MEAN|1.54||0.6873|TWO_SIDED|||||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are from the multiple imputation model for the intended (but not correctly pre-specified) H5b assessment, which evaluates whether moderation of pictorial warnings effects would vary by whether the pictorial warnings included inserts or not. We expected that moderation effects of baseline self-efficacy would be larger for pictorial warnings only (vs control) than for pictorial warnings AND inserts (vs control) (see Statistical Analysis Plan, Model 4).||||0.6873
72588659|NCT04075682|144708207|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|-0.35|STANDARD_ERROR_OF_MEAN|0.39||0.37|TWO_SIDED|95.0|-1.12|0.41||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordinal regression models that accounted for repeated measures at both the day- and individual-levels.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the pre-specified H2 assessment (see Statistical Analysis Plan, Model 1), comparing groups that received pictorial warnings (pictorial warning only AND insert + pictorial warnings) with the groups that did not (insert only AND control). We expected that the outcome would be higher in the pictorial warning groups than in the no pictorial warning groups.||0.41|-1.12|0.37
72588660|NCT04075682|144708208|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Rate ratio|0.99|STANDARD_ERROR_OF_MEAN|0.05||0.92|TWO_SIDED|95.0|0.9|1.1||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Negative binomial regression|We estimated negative binomial regression models, as there is a single measure for each person and so there are no repeated measures.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the pre-specified H1 assessment (see Statistical Analysis Plan, Model 1), comparing groups that received inserts (insert only AND insert + pictorial warnings) with the groups that did not (pictorial warning only AND control). We expected that the outcome would be higher in the insert groups than in the no insert groups.||1.10|0.90|0.92
72588661|NCT04075682|144708208|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Rate ratio|1.0|STANDARD_ERROR_OF_MEAN|0.05||0.95|TWO_SIDED|95.0|0.9|1.11||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Negative binomial regression|We estimated negative binomial regression models, as there is a single measure for each person and so there are no repeated measures.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the pre-specified H2 assessment (see Statistical Analysis Plan, Model 1), comparing groups that received pictorial warnings (pictorial warning only AND insert + pictorial warnings) with the groups that did not (insert only AND control). We expected that the outcome would be higher in the pictorial warning groups than in the no pictorial warning groups.||1.11|0.90|0.95
72588662|NCT04075682|144708208|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Rate ratio|0.99|STANDARD_ERROR_OF_MEAN|0.08||0.85|TWO_SIDED|95.0|0.85|1.14||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Negative binomial regression|We estimated negative binomial regression models, as there is a single measure for each person and so there are no repeated measures.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the pre-specified H3 assessment (see Statistical Analysis Plan, Model 1), comparing the group that received inserts and pictorial warnings with the group that received inserts only. We expected that this outcome would be higher in the insert and pictorial warning group than in the insert only group.||1.14|0.85|0.85
72588663|NCT04075682|144708208|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Rate ratio|0.98|STANDARD_ERROR_OF_MEAN|0.07||0.75|TWO_SIDED|95.0|0.84|1.13||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Negative binomial regression|We estimated negative binomial regression models, as there is a single measure for each person and so there are no repeated measures.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the pre-specified H4 assessment (see Statistical Analysis Plan, Model 1), comparing the group that received inserts and pictorial warnings with the group that received pictorial warnings only. We expected that this outcome would be higher in the insert and pictorial warning group than in the pictorial warning only group.||1.13|0.84|0.75
72588664|NCT04075682|144708208|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Rate ratio|0.97|STANDARD_ERROR_OF_MEAN|0.11||0.78|TWO_SIDED|95.0|0.78|1.2||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Negative binomial regression|We estimated negative binomial regression models, as there is a single measure for each person and so there are no repeated measures.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H5a assessment, which evaluates moderation of the pre-specified H2 assessment. We expected that the effect of pictorial HWLs (averaged over insert) vs no pictorial HWLs (averaged over insert) on the outcome would be stronger for higher vs lower self-efficacy (see Statistical Analysis Plan, Model 4)||1.20|0.78|0.78
72588665|NCT04075682|144708208|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Rate ratio|1.31|STANDARD_ERROR_OF_MEAN|0.22||0.11|TWO_SIDED|95.0|0.94|1.82||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Negative binomial regression|We estimated negative binomial regression models, as there is a single measure for each person and so there are no repeated measures.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H5b assessment, which evaluates whether moderation of pictorial warnings effects would vary by whether the pictorial warnings included inserts or not. We expected that moderation effects of baseline self-efficacy would be larger for pictorial warnings only (vs control) than for pictorial warnings AND inserts (vs control) (see Statistical Analysis Plan, Model 4).||1.82|0.94|0.11
72588666|NCT04075682|144708208|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Rate ratio|0.99|STANDARD_ERROR_OF_MEAN|0.11||0.93|TWO_SIDED|95.0|0.8|1.22||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Negative binomial regression|We estimated negative binomial regression models, as there is a single measure for each person and so there are no repeated measures.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6a assessment, which evaluates moderation of the pre-specified H1 assessment. We expected that the effect of inserts (averaged over pictorial warnings) compared to no inserts (averaged over pictorial warnings) on the outcome would be stronger for those with higher than lower education (see Statistical Analysis Plan, Model 5).||1.22|0.80|0.93
72588667|NCT04075682|144708208|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Rate ratio|0.98|STANDARD_ERROR_OF_MEAN|0.11||0.86|TWO_SIDED|95.0|0.78|1.23||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Negative binomial regression|We estimated negative binomial regression models, as there is a single measure for each person and so there are no repeated measures.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6a assessment, which evaluates moderation of the pre-specified H1 assessment. We expected that the effect of inserts (averaged over pictorial warnings) compared to no inserts (averaged over pictorial warnings) on the outcome would be stronger for those with higher than lower literacy (see Statistical Analysis Plan, Model 5).||1.23|0.78|0.86
72588668|NCT04075682|144708208|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Rate ratio|0.99|STANDARD_ERROR_OF_MEAN|0.11||0.94|TWO_SIDED|95.0|0.81|1.22||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Negative binomial regression|We estimated negative binomial regression models, as there is a single measure for each person and so there are no repeated measures.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6a assessment, which evaluates moderation of the pre-specified H1 assessment. We expected that the effect of inserts (averaged over pictorial warnings) compared to no inserts (averaged over pictorial warnings) on the outcome would be stronger for those with lower than higher delayed discounting (see Statistical Analysis Plan, Model 5).||1.22|0.81|0.94
72588669|NCT04075682|144708208|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Rate ratio|1.29|STANDARD_ERROR_OF_MEAN|0.21||0.13|TWO_SIDED|95.0|0.93|1.78||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Negative binomial regression|We estimated negative binomial regression models, as there is a single measure for each person and so there are no repeated measures.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6b assessment, which evaluated whether the moderation of insert effects would vary by whether the inserts included pictorial warnings or not. We expected that moderation by baseline education would be stronger for insert only (vs control) than for inserts AND pictorial warnings (vs control) (see Statistical Analysis Plan, Model 5).||1.78|0.93|0.13
72588670|NCT04075682|144708208|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Rate ratio|0.99|STANDARD_ERROR_OF_MEAN|0.18||0.96|TWO_SIDED|95.0|0.7|1.41||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Negative binomial regression|We estimated negative binomial regression models, as there is a single measure for each person and so there are no repeated measures.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6b assessment, which evaluated whether the moderation of insert effects would vary by whether the inserts included pictorial warnings or not. We expected that moderation by baseline literacy would be larger for insert only (vs control) than for inserts AND pictorial warnings (vs control) (see Statistical Analysis Plan, Model 5).||1.41|0.70|0.96
72588671|NCT04075682|144708208|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Rate ratio|0.99|STANDARD_ERROR_OF_MEAN|0.16||0.95|TWO_SIDED|95.0|0.72|1.36||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Negative binomial regression|We estimated negative binomial regression models, as there is a single measure for each person and so there are no repeated measures.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6b assessment, which evaluated whether the moderation of insert effects would vary by whether the inserts included pictorial warnings or not. We expected that moderation by baseline delay discounting would be larger for insert only (vs control) than for inserts AND pictorial warnings (vs control) (see Statistical Analysis Plan, Model 5).||1.36|0.72|0.95
72588672|NCT01680861|144708240|SUPERIORITY_OR_OTHER|||||||0.32|||||||Log Rank|||||||0.32
72588673|NCT01680861|144708241|SUPERIORITY_OR_OTHER|||||||0.99|||||||Log Rank|||||||0.99
72588674|NCT01680861|144708242|SUPERIORITY_OR_OTHER|||||||1|||||||Log Rank|||||||1.0
72588675|NCT01680861|144708243|SUPERIORITY_OR_OTHER|||||||0.06|||||||t-test, 2 sided|||||||0.06
72588676|NCT01680861|144708244|SUPERIORITY_OR_OTHER|||||||0.18|||||||t-test, 2 sided|||||||0.18
72588677|NCT01680861|144708245|SUPERIORITY_OR_OTHER|||||||0.65|||||||t-test, 2 sided|||||||0.65
72588678|NCT04791319|144708247|SUPERIORITY||MH weights|7.1||||0.489|TWO_SIDED|95.0|-12.1|26.2||Threshold for significance at 0.05 level.|Chi-squared|||||26.2|-12.1|0.489
72588679|NCT04791319|144708247|SUPERIORITY||MH Weights|7.1||||0.448|TWO_SIDED|95.0|-9.4|23.7|||Chi-squared|||||23.7|-9.4|0.448
72588680|NCT04791319|144708247|SUPERIORITY||MH Weights|42.0||||0.001|TWO_SIDED|95.0|22.9|61.1|||Chi-squared|||||61.1|22.9|0.001
72588681|NCT00520533|144708290|SUPERIORITY|||||||0.194|||||||t-test, 2 sided|||Comparison of Biological T1/2 at Week 1 and Week 5.||||0.194
72414115|NCT03086447|144337205|OTHER|It was deemed that a total of 135 subjects in the Test group is sufficient to demonstrate statistical acceptance of lens stability with a minimum of 90% statistical power using the reference incidence rate of 95% with a correlation of 0.8 between eyes.|Proportion|100.0|||||TWO_SIDED|95.0|96.5|100.0||All primary hypotheses were simultaneously evaluated using a significance level of 0.05 following the intersection-union principal. All primary hypotheses must be met to claim success of the study objectives.|Binomial proportion with Agrestic-Coull||All eyes (100%) in the Test group had acceptable stability at fitting.|Proportion of eyes with acceptable stability assessed at fitting (visit 1) in the Test group was compared to the historical control rate of 80%. Lower 95% confidence limit was compared to 0.8.||100.0|96.5|
72588682|NCT00520533|144708291|SUPERIORITY|||||||0.172|||||||t-test, 2 sided|||Comparison of Effective T1/2 at Week 1 and Week 5.||||0.172
72588683|NCT02397122|144708300|SUPERIORITY|||||||0.259|||||||Mann-Whitney|||Baseline||||0.259
72588684|NCT02397122|144708300|SUPERIORITY|||||||0.097|||||||Mann-Whitney|||6 weeks||||0.097
72588685|NCT02397122|144708300|SUPERIORITY|||||||0.07||||||\<0.05|Mann-Whitney U|||6 months||||0.070
72588686|NCT02397122|144708301|SUPERIORITY|||||||0.067|||||||Mann-Whitney|||Baseline||||0.067
72588687|NCT02397122|144708301|SUPERIORITY|||||||0.13|||||||Mann-Whitney|||6 weeks||||0.130
72588688|NCT02397122|144708301|SUPERIORITY|||||||0.128||||||\<0.05|Mann-Whitney U|||6 months||||0.128
72588689|NCT02397122|144708302|SUPERIORITY|||||||0.298|||||||Mann-Whitney|||Baseline||||0.298
72588690|NCT02397122|144708302|SUPERIORITY|||||||0.152|||||||Mann-Whitney|||6 weeks||||0.152
72588691|NCT02397122|144708302|SUPERIORITY|||||||0.317||||||\<0.05|Mann-Whitney U|||6 months||||0.317
72588692|NCT02397122|144708303|SUPERIORITY|||||||0.136|||||||Mann-Whitney|||Baseline||||0.136
72588693|NCT02397122|144708303|SUPERIORITY|||||||0.041|||||||Mann-Whitney|||6 weeks||||0.041
72588694|NCT02397122|144708303|SUPERIORITY|||||||0.064||||||\<0.05|Mann-Whitney U|||6 months||||0.064
72588695|NCT02397122|144708304|SUPERIORITY|||||||0.245|||||||Mann-Whitney|||Baseline||||0.245
72588696|NCT02397122|144708304|SUPERIORITY|||||||0.099|||||||Mann-Whitney|||6 weeks||||0.099
72588697|NCT02397122|144708304|SUPERIORITY|||||||0.077|||||||Mann-Whitney U|||||||0.077
72588698|NCT02397122|144708305|SUPERIORITY|||||||0.946|||||||Mann-Whitney|||Baseline||||0.946
72588699|NCT02397122|144708305|SUPERIORITY|||||||0.001|||||||Mann-Whitney|||6 weeks||||0.001
72588700|NCT02397122|144708305|SUPERIORITY|||||||0.001||||||\<0.05|Mann-Whitney U|||6 months||||0.001
72588701|NCT05831644|144708306|SUPERIORITY||Mean Difference (Final Values)|-0.124||||0.1925|TWO_SIDED|90.0|-0.285|0.037|||ANOVA|||The primary endpoint (RHI score) was compared between treatments using an analysis of variance model (ANOVA) with treatment and period as fixed effects and subjects as random effect.||0.037|-0.285|0.1925
72588702|NCT05831644|144708307|SUPERIORITY||Mean Difference (Final Values)|-4.94||||0.1941|TWO_SIDED|90.0|-11.392|1.513|||ANOVA|||The secondary pharmacodynamic endpoint (AI) was analysed using a similar ANOVA model as for the primary endpoint.||1.513|-11.392|0.1941
72588703|NCT02703467|144708371|SUPERIORITY||||||>|0.05||||||calculated|t-test, 2 sided|||||||>0.05
72588704|NCT03010800|144708383|SUPERIORITY|||||||0.0469||||||One subject experienced incontinence with the Yoni.Fit in place (#8) (9.2 g Pad Wt. Without and 17.3 g Pad Wt. With). This was attributed to incorrect Yoni.Fit sizing. This subject was not included in the p-value calculation.|Wilcoxon (Mann-Whitney)|||"Null hypothesis is that the pad weights With Yoni.Fit and Without Yoni.Fit are equivalent.~A one-sided Wilcoxson paired T-test of the group means will be performed. If the p-value is significant, the null hypothesis will be rejected."||||0.0469
72588705|NCT04463251|144708384|OTHER||Least square means ratio|0.58|||||TWO_SIDED|95.0|0.37|0.91|||||"Least square means ratio with two-sided Dunnett's adjusted 95% CI for RPH-104 80 mg / Placebo.~Ratio was calculated instead of difference because log data transformation."|"The following (two-sided) hypotheses were tested:~* Null hypothesis H0: the ratio of the geometric mean of hsCRP-AUC(days 1-14) in RPH-104 group to the geometric mean of hsCRP-AUC(days 1-14) in the placebo group is equal to 1.~* Alternative hypothesis H1: the ratio of the geometric mean of hsCRP-AUC(days 1-14) in RPH-104 group to the geometric mean of hsCRP-AUC(days 1-14) in the placebo group is different from 1."||0.91|0.37|
72588706|NCT04463251|144708384|OTHER||Least square means ratio|0.58|||||TWO_SIDED|95.0|0.37|0.91|||||"Least square means ratio with two-sided Dunnett's adjusted 95% CI for RPH-104 160 mg / Placebo.~Ratio was calculated instead of difference because log data transformation."|"The following (two-sided) hypotheses were tested:~* Null hypothesis H0: the ratio of the geometric mean of hsCRP-AUC(days 1-14) in RPH-104 group to the geometric mean of hsCRP-AUC(days 1-14) in the placebo group is equal to 1.~* Alternative hypothesis H1: the ratio of the geometric mean of hsCRP-AUC(days 1-14) in RPH-104 group to the geometric mean of hsCRP-AUC(days 1-14) in the placebo group is different from 1."||0.91|0.37|
72588707|NCT04463251|144708385|OTHER||Least square means ratio|0.54|||||TWO_SIDED|95.0|0.34|0.87|||||"Least square means ratio with two-sided Dunnett's adjusted 95% CI for RPH-104 80 mg / Placebo.~Ratio was calculated instead of difference because log data transformation."|"The following (two-sided) hypotheses were tested:~* Null hypothesis H0: the ratio of the geometric mean of hsCRP-AUC(days 1-14) in RPH-104 group to the geometric mean of hsCRP-AUC(days 1-14) in the placebo group is equal to 1.~* Alternative hypothesis H1: the ratio of the geometric mean of hsCRP-AUC(days 1-14) in RPH-104 group to the geometric mean of hsCRP-AUC(days 1-14) in the placebo group is different from 1."||0.87|0.34|
72588708|NCT04463251|144708385|OTHER||Least square means ratio|0.6|||||TWO_SIDED|95.0|0.37|0.95|||||"Least square means ratio with two-sided Dunnett's adjusted 95% CI for RPH-104 160 mg / Placebo.~Ratio was calculated instead of difference because log data transformation."|"The following (two-sided) hypotheses were tested:~* Null hypothesis H0: the ratio of the geometric mean of hsCRP-AUC(days 1-14) in RPH-104 group to the geometric mean of hsCRP-AUC(days 1-14) in the placebo group is equal to 1.~* Alternative hypothesis H1: the ratio of the geometric mean of hsCRP-AUC(days 1-14) in RPH-104 group to the geometric mean of hsCRP-AUC(days 1-14) in the placebo group is different from 1."||0.95|0.37|
72588709|NCT04463251|144708386|OTHER||Least square means ratio|0.56|||||TWO_SIDED|95.0|0.34|0.91|||||"Least square means ratio with two-sided Dunnett's adjusted 95% CI for RPH-104 80 mg / Placebo.~Ratio was calculated instead of difference because log data transformation"|"The following (two-sided) hypotheses were tested:~* Null hypothesis H0: the ratio of the geometric mean of hsCRP-AUC(days 1-14) in RPH-104 group to the geometric mean of hsCRP-AUC(days 1-14) in the placebo group is equal to 1.~* Alternative hypothesis H1: the ratio of the geometric mean of hsCRP-AUC(days 1-14) in RPH-104 group to the geometric mean of hsCRP-AUC(days 1-14) in the placebo group is different from 1."||0.91|0.34|
72588710|NCT04463251|144708386|OTHER||Least square means ratio|0.61|||||TWO_SIDED|95.0|0.38|0.98|||||"Least square means ratio with two-sided Dunnett's adjusted 95% CI for RPH-104 160 mg / Placebo.~Ratio was calculated instead of difference because log data transformation."|"The following (two-sided) hypotheses were tested:~* Null hypothesis H0: the ratio of the geometric mean of hsCRP-AUC(days 1-14) in RPH-104 group to the geometric mean of hsCRP-AUC(days 1-14) in the placebo group is equal to 1.~* Alternative hypothesis H1: the ratio of the geometric mean of hsCRP-AUC(days 1-14) in RPH-104 group to the geometric mean of hsCRP-AUC(days 1-14) in the placebo group is different from 1."||0.98|0.38|
72588711|NCT04463251|144708387|OTHER||Least square means ratio|0.56|||||TWO_SIDED|95.0|0.34|0.91|||||"Least square means ratio with two-sided Dunnett's adjusted 95% CI for RPH-104 80 mg / Placebo.~Ratio was calculated instead of difference because log data transformation"|"The following (two-sided) hypotheses were tested:~* Null hypothesis H0: the ratio of the geometric mean of hsCRP-AUC(days 1-14) in RPH-104 group to the geometric mean of hsCRP-AUC(days 1-14) in the placebo group is equal to 1.~* Alternative hypothesis H1: the ratio of the geometric mean of hsCRP-AUC(days 1-14) in RPH-104 group to the geometric mean of hsCRP-AUC(days 1-14) in the placebo group is different from 1."||0.91|0.34|
72588712|NCT04463251|144708387|OTHER||Least square means ratio|0.61|||||TWO_SIDED|95.0|0.38|0.98|||||"Least square means ratio with two-sided Dunnett's adjusted 95% CI for RPH-104 160 mg / Placebo.~Ratio was calculated instead of difference because log data transformation."|"The following (two-sided) hypotheses were tested:~* Null hypothesis H0: the ratio of the geometric mean of hsCRP-AUC(days 1-14) in RPH-104 group to the geometric mean of hsCRP-AUC(days 1-14) in the placebo group is equal to 1.~* Alternative hypothesis H1: the ratio of the geometric mean of hsCRP-AUC(days 1-14) in RPH-104 group to the geometric mean of hsCRP-AUC(days 1-14) in the placebo group is different from 1."||0.98|0.38|
72588713|NCT04463251|144708388|OTHER||Least square means ratio|0.52|||||TWO_SIDED|95.0|0.34|0.81||||||"The following (two-sided) hypotheses were tested:~Null hypothesis H0: the ratio of the geometric mean of hsCRP-AUC(days 1-28) in RPH-104 group to the geometric mean of hsCRP-AUC(days 1-28) in the placebo group is equal to 1.~Alternative hypothesis H1: the ratio of the geometric mean of hsCRP-AUC(days 1-28) in RPH-104 group to the geometric mean of hsCRP-AUC(days 1-28) in the placebo group is different from 1."|"Least square means ratio with two-sided Dunnett's adjusted 95% CI for RPH-104 80 mg / Placebo.~Ratio was calculated instead of difference because log data transformation."|0.81|0.34|
72588714|NCT04463251|144708388|OTHER||Least square means ratio|0.48|||||TWO_SIDED|95.0|0.31|0.74|||||"Least square means ratio with two-sided Dunnett's adjusted 95% CI for RPH-104 160 mg / Placebo.~Ratio was calculated instead of difference because log data transformation."|"The following (two-sided) hypotheses were tested:~Null hypothesis H0: the ratio of the geometric mean of hsCRP-AUC(days 1-28) in RPH-104 group to the geometric mean of hsCRP-AUC(days 1-28) in the placebo group is equal to 1.~Alternative hypothesis H1: the ratio of the geometric mean of hsCRP-AUC(days 1-28) in RPH-104 group to the geometric mean of hsCRP-AUC(days 1-28) in the placebo group is different from 1."||0.74|0.31|
72588715|NCT04463251|144708389|OTHER||Least square means ratio|0.47|||||TWO_SIDED|95.0|0.29|0.75|||||"Least square means ratio with two-sided Dunnett's adjusted 95% CI for RPH-104 80 mg / Placebo.~Ratio was calculated instead of difference because log data transformation."|"The following (two-sided) hypotheses were tested:~Null hypothesis H0: the ratio of the geometric mean of hsCRP-AUC(days 1-28) in RPH-104 group to the geometric mean of hsCRP-AUC(days 1-28) in the placebo group is equal to 1.~Alternative hypothesis H1: the ratio of the geometric mean of hsCRP-AUC(days 1-28) in RPH-104 group to the geometric mean of hsCRP-AUC(days 1-28) in the placebo group is different from 1."||0.75|0.29|
72588716|NCT04463251|144708389|OTHER||Least square means ratio|0.47|||||TWO_SIDED|95.0|0.3|0.75|||||"Least square means ratio with two-sided Dunnett's adjusted 95% CI for RPH-104 160 mg / Placebo.~Ratio was calculated instead of difference because log data transformation."|"The following (two-sided) hypotheses were tested:~Null hypothesis H0: the ratio of the geometric mean of hsCRP-AUC(days 1-28) in RPH-104 group to the geometric mean of hsCRP-AUC(days 1-28) in the placebo group is equal to 1.~Alternative hypothesis H1: the ratio of the geometric mean of hsCRP-AUC(days 1-28) in RPH-104 group to the geometric mean of hsCRP-AUC(days 1-28) in the placebo group is different from 1."||0.75|0.30|
72588717|NCT03386994|144708438|OTHER|||||||0.0002|||||||ANOVA|Total annual IPF-related costs||||||0.0002
72588718|NCT03386994|144708438|OTHER|||||||0.0007|||||||ANOVA|Annual direct health IPF-related costs||||||0.0007
72588719|NCT03386994|144708438|OTHER||||||<|0.0001|||||||ANOVA|Annual direct non-health IPF-related costs||||||<0.0001
72588720|NCT03386994|144708438|OTHER|||||||0.6839|||||||ANOVA|Annual indirect IPF-related costs||||||0.6839
72588721|NCT03386994|144708439|OTHER|||||||0.002|||||||Kruskal-Wallis|Timepoint: T0||||||0.0020
72588722|NCT03386994|144708439|OTHER|||||||0.1385|||||||Kruskal-Wallis|Timepoint: T6||||||0.1385
72588723|NCT03386994|144708439|OTHER|||||||0.0233|||||||Kruskal-Wallis|Timepoint: T12||||||0.0233
72588724|NCT03386994|144708440|OTHER|||||||0.156||||||Timepoint: T0|Kruskal-Wallis|||||||0.1560
72588725|NCT03386994|144708440|OTHER|||||||0.3144||||||Timepoint: T6|Kruskal-Wallis|||||||0.3144
72588726|NCT03386994|144708440|OTHER|||||||0.2019||||||Timepoint: T12|Kruskal-Wallis|||||||0.2019
72588727|NCT03386994|144708441|OTHER|||||||0.0075||||||Timepoint: T0|Kruskal-Wallis|||||||0.0075
72588728|NCT03386994|144708441|OTHER|||||||0.0361||||||Timepoint: T6|Kruskal-Wallis|||||||0.0361
72588729|NCT03386994|144708441|OTHER|||||||0.4794||||||Timepoint: T12|Kruskal-Wallis|||||||0.4794
72588730|NCT03386994|144708442|OTHER|||||||0.0333|||||||Fisher Exact|||||||0.0333
72588731|NCT03386994|144708444|OTHER|||||||0.4711|||||||ANOVA|Total annual IPF-related costs||||||0.4711
72588732|NCT03386994|144708444|OTHER|||||||0.4095|||||||ANOVA|Annual direct health IPF-related costs||||||0.4095
72588733|NCT03386994|144708444|OTHER|||||||0.0435|||||||ANOVA|Annual direct non-health IPF-related costs||||||0.0435
72588734|NCT03386994|144708444|OTHER|||||||0.5479|||||||ANOVA|Annual indirect IPF-related costs||||||0.5479
72588735|NCT03386994|144708446|OTHER|||||||0.7486|||||||ANOVA|Total annual IPF-related costs||||||0.7486
72588736|NCT03386994|144708446|OTHER|||||||0.7652|||||||ANOVA|Annual direct health IPF-related costs||||||0.7652
72588737|NCT03386994|144708446|OTHER|||||||0.0037|||||||ANOVA|Annual direct non-health IPF-related costs||||||0.0037
72588738|NCT03386994|144708446|OTHER|||||||0.6119|||||||ANOVA|Annual indirect IPF-related costs||||||0.6119
72588739|NCT03386994|144708447|OTHER|||||||0.1581|||||||ANOVA|Total annual IPF-related costs||||||0.1581
72588740|NCT03386994|144708447|OTHER|||||||0.1581|||||||ANOVA|Annual direct health IPF-related costs||||||0.1581
72588741|NCT03386994|144708447|OTHER|||||||0.7165|||||||ANOVA|Annual direct non-health IPF-related costs||||||0.7165
72588742|NCT03386994|144708447|OTHER|||||||1|||||||ANOVA|Annual indirect IPF-related costs||||||1.0000
72588743|NCT03386994|144708448|OTHER|||||||0.0733|||||||Kruskal-Wallis|||||||0.0733
72588744|NCT03386994|144708450|OTHER|||||||0.0207|||||||Kruskal-Wallis|||||||0.0207
72588745|NCT03386994|144708451|OTHER|||||||0.0942|||||||Kruskal-Wallis|||||||0.0942
72588746|NCT03386994|144708452|OTHER|||||||0.0747|||||||Kruskal-Wallis|||||||0.0747
72588747|NCT03386994|144708454|OTHER|||||||0.1282|||||||Kruskal-Wallis|||||||0.1282
72588748|NCT03386994|144708455|OTHER|||||||0.7471|||||||Kruskal-Wallis|||||||0.7471
72588749|NCT00877487|144708489|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-15.23|||<|0.0001|TWO_SIDED|95.0|-19.1|-11.4|||ANCOVA|||||-11.4|-19.1|<0.0001
72588750|NCT00877487|144708490|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||Cochran-Mantel-Haenszel|||||||<0.0001
72588751|NCT00877487|144708491|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||Chi-squared|||||||<0.0001
72588752|NCT02702388|144708502|NON_INFERIORITY|Odds ratio of ORR as of Week 24 response (18 mg vs 24 mg) along with its 95% confidence interval (CI) using the Cochran-Mantel-Haenszel (CMH) method, stratified by the randomization stratification factors. The test was performed per the 95% CI using the noninferiority margin of 0.4. Noninferiority will be declared if the lower limit of the 95% CI for the odds ratio is greater than 0.4.|Odds Ratio (OR)|0.5|||||TWO_SIDED|95.0|0.26|0.96||||||||0.96|0.26|
72588753|NCT02729051|144708535|NON_INFERIORITY|If the lower bound of the two-sided 95% confidence interval around the (FF/UMEC/VI versus FF/VI+UMEC) treatment difference is above -50 milliliter (mL) then FF/UMEC/VI was to be considered non-inferior to FF/VI+UMEC.|Mean Difference (Final Values)|0.018|STANDARD_ERROR_OF_MEAN|0.0161|||TWO_SIDED|95.0|-0.013|0.05|||||MMRM method included covariates of Baseline FEV1, stratum (number of long-acting bronchodilators per day during the run-in: 0/1 or 2), visit, geographical region, treatment, visit by treatment and visit by Baseline interaction.|||0.050|-0.013|
72414116|NCT03086447|144337206|OTHER|It was deemed that a total of 135 subjects in the Test group is sufficient to demonstrate statistical acceptance of absolute rotation with a minimum of 90% statistical power using the reference incidence rate of 95% with a correlation of 0.8 between eyes.|Least square mean proportion|99.6|||||TWO_SIDED|95.0|97.5|99.9||All primary hypotheses were simultaneously evaluated using a significance level of 0.05 following the intersection-union principal. All primary hypotheses must be met to claim success of the study objectives.|Linear mixed model with binomial dist.||Above 80% of eyes in the Test group had acceptable rotation.|Proportion of eyes with acceptable absolute rotation assessed at 15-minute upon insertion (fitting, visit 1) in the Test group was compared to the historical control rate of 80%. Lower 95% confidence limit was compared to 0.8.||99.9|97.5|
72414117|NCT03086447|144337207|OTHER|It was deemed that a total of 135 subjects per each study group is sufficient to demonstrate no statistical difference in the CS incidence rate between the Test and Control groups with a minimum of 80% statistical power using the reference incidence rate of 0.005% with a correlation of 0.3 between eyes within subject.|Odds Ratio (OR)|0.29|||||TWO_SIDED|95.0|0.004|1.437||All primary hypotheses were simultaneously evaluated using a significance level of 0.05 following the intersection-union principal. All primary hypotheses must be met to claim success of the study objectives.|Bayesian beta-binomial model|A 95% credible interval for the posterior estimate (Test over Control) was used to test no difference between the Test and Control groups.|odds ratio calculated as Test over Control|Proportion of eyes with unacceptable corneal staining (CS) throughout all planned and unplanned visits in the Test group was compared to that in the Control group.||1.437|0.004|
72414118|NCT03086447|144337208|NON_INFERIORITY|A non-inferiority margin of -5 points was used. This margin is based on a 10% shift in the distribution of CLUE score.|Mean Difference (Final Values)|6.8|STANDARD_DEVIATION|2.39|||TWO_SIDED|95.0|2.1|11.5|||Linear mixed model|A 95% confidence interval for the least square mean difference was used to demonstrate non-inferiority of the Test relative to the Control groups.|Mean difference was calculated as Test minus Control|Sample size calculation was performed considering the effect size of 5 (Test minus Control) to achieve a minimum statistical power of 90% at a 5% significance level.||11.5|2.1|
72588754|NCT02729051|144708536|OTHER||Odds Ratio (OR)|0.92|||||TWO_SIDED|95.0|0.71|1.2|||||Analysis included covariates of treatment group, stratum (number of long-acting bronchodilators per day during the run-in: 0/1 or 2), geographical region, visit, Baseline, Baseline by visit and treatment by visit interactions.|||1.20|0.71|
72588755|NCT02729051|144708537|OTHER||Least Square Mean Difference|-0.906|STANDARD_ERROR_OF_MEAN|0.8327|||TWO_SIDED|95.0|-2.54|0.728|||||Analysis performed using a repeated measures model with covariates of Baseline SGRQ, stratum (number of long-acting bronchodilators per day during the run-in: 0/1 or 2), visit, geographical region, treatment, visit by treatment and visit by Baseline.|||0.728|-2.540|
72588756|NCT02729051|144708538|OTHER||Odds Ratio (OR)|0.95|||||TWO_SIDED|95.0|0.72|1.25|||||Include covariates of treatment group, stratum (number of long-acting bronchodilators/ day during the run-in: 0/1 or 2), geographical region, visit, Baseline dyspnea index (BDI) focal score, BDI focal score/ visit and treatment/ visit interactions.|||1.25|0.72|
72588757|NCT02729051|144708539|OTHER||Mean Difference (Final Values)|0.137|STANDARD_ERROR_OF_MEAN|0.1773|||TWO_SIDED|95.0|-0.211|0.485|||||Analysis included covariates of BDI focal score, stratum (number of long-acting bronchodilators per day during the run-in: 0/1 or 2), visit, geographical region, treatment, visit by treatment and visit by BDI Focal score interactions.|||0.485|-0.211|
72588758|NCT02729051|144708540|OTHER||Hazard Ratio (HR)|0.87|||||TWO_SIDED|95.0|0.68|1.12|||||Analysis was performed using a Cox proportional hazards model.|||1.12|0.68|
72588759|NCT04740827|144708555|SUPERIORITY||Least Squares Mean Difference|-2.43|STANDARD_ERROR_OF_MEAN|0.426|<|0.0001|TWO_SIDED|95.0|-3.27|-1.59|||MMRM||MMRM=baseline monthly migraine days as covariate, treatment group, visit, region and number of classes of failed prior treatments as fixed factors; treatment group and baseline-by-visit as interaction terms, with an unstructured covariance matrix.|||-1.59|-3.27|<0.0001
72588760|NCT04740827|144708556|SUPERIORITY||Least Squares Mean Difference|-2.35|STANDARD_ERROR_OF_MEAN|0.425|<|0.0001|TWO_SIDED|95.0|-3.19|-1.52|||MMRM||MMRM=baseline monthly migraine days as covariate, treatment group, visit, region and number of classes of failed prior treatments as fixed factors; treatment group and baseline-by-visit as interaction terms, with an unstructured covariance matrix.|||-1.52|-3.19|<0.0001
72588761|NCT04740827|144708557|SUPERIORITY||Odds Ratio (OR)|5.15|||<|0.0001|TWO_SIDED|95.0|3.02|8.79|||Regression, Logistic||Odds ratio and p-value are based on logistic regression with treatment group, region, baseline monthly migraine days, and number of classes of failed prior prophylactic treatments (2 and \>2) as explanatory variables.|||8.79|3.02|<0.0001
72588762|NCT04740827|144708558|SUPERIORITY||Odds Ratio (OR)|4.82|||<|0.0001|TWO_SIDED|95.0|2.85|8.14|||Regression, Logistic||Odds ratio and p-value are based on logistic regression with treatment group, region, baseline monthly migraine days, and number of classes of failed prior prophylactic treatments (2 and \>2) as explanatory variables.|||8.14|2.85|<0.0001
72588763|NCT04740827|144708559|SUPERIORITY||Least Squares Mean Difference|-2.28|STANDARD_ERROR_OF_MEAN|0.44|<|0.0001|TWO_SIDED|95.0|-3.15|-1.42|||MMRM||MMRM=baseline as covariate, treatment group, visit, region, number of classes of failed prior treatments, number of migraine days during baseline period as fixed factors; treatment group and baseline-by-visit with an unstructured covariance matrix.|||-1.42|-3.15|<0.0001
72588764|NCT04740827|144708560|SUPERIORITY||Least Squares Mean Difference|-2.19|STANDARD_ERROR_OF_MEAN|0.439|<|0.0001|TWO_SIDED|95.0|-3.05|-1.32|||MMRM||MMRM=baseline as covariate, treatment group, visit, region, number of classes of failed prior treatments, number of migraine days during baseline period as fixed factors; treatment group and baseline-by-visit with an unstructured covariance matrix.|||-1.32|-3.05|<0.0001
72588765|NCT04740827|144708561|SUPERIORITY||Least Squares Mean Difference|-2.68|STANDARD_ERROR_OF_MEAN|0.381|<|0.0001|TWO_SIDED|95.0|-3.43|-1.93|||MMRM||MMRM=baseline as covariate, treatment group, visit, region, number of classes of failed prior treatments, number of migraine days during baseline period as fixed factors; treatment group and baseline-by-visit with an unstructured covariance matrix.|||-1.93|-3.43|<0.0001
72588766|NCT04740827|144708562|SUPERIORITY||Least Squares Mean Difference|-2.61|STANDARD_ERROR_OF_MEAN|0.38|<|0.0001|TWO_SIDED|95.0|-3.36|-1.86|||MMRM||MMRM=baseline as covariate, treatment group, visit, region, number of classes of failed prior treatments, number of migraine days during baseline period as fixed factors; treatment group and baseline-by-visit with an unstructured covariance matrix.|||-1.86|-3.36|<0.0001
72588767|NCT04740827|144708563|SUPERIORITY||Least Squares Mean Difference|17.67|STANDARD_ERROR_OF_MEAN|2.348|<|0.0001|TWO_SIDED|95.0|13.05|22.3|||MMRM||MMRM=baseline as covariate, treatment group, visit, region, number of classes of failed prior treatments, number of migraine days during baseline period as fixed factors; treatment group and baseline-by-visit with an unstructured covariance matrix.|||22.30|13.05|<0.0001
72588768|NCT04740827|144708564|SUPERIORITY||Least Squares Mean Difference|17.88|STANDARD_ERROR_OF_MEAN|2.308|<|0.0001|TWO_SIDED|95.0|13.34|22.42|||MMRM||MMRM=baseline as covariate, treatment group, visit, region, number of classes of failed prior treatments, number of migraine days during baseline period as fixed factors; treatment group and baseline-by-visit with an unstructured covariance matrix.|||22.42|13.34|<0.0001
72588769|NCT04740827|144708565|SUPERIORITY||Least Squares Mean Difference|-4.71|STANDARD_ERROR_OF_MEAN|0.844|<|0.0001|TWO_SIDED|95.0|-6.37|-3.05|||MMRM||MMRM=baseline as covariate, treatment group, visit, region, number of classes of failed prior treatments, number of migraine days during baseline period as fixed factors; treatment group and baseline-by-visit with an unstructured covariance matrix.|||-3.05|-6.37|<0.0001
72588770|NCT04740827|144708566|SUPERIORITY||Least Squares Mean Difference|-4.39|STANDARD_ERROR_OF_MEAN|0.786|<|0.0001|TWO_SIDED|95.0|-5.94|-2.85|||MMRM||MMRM=baseline as covariate, treatment group, visit, region, number of classes of failed prior treatments, number of migraine days during baseline period as fixed factors; treatment group and baseline-by-visit with an unstructured covariance matrix.|||-2.85|-5.94|<0.0001
72588771|NCT04740827|144708567|SUPERIORITY||Least Squares Mean Difference|-6.42|STANDARD_ERROR_OF_MEAN|0.912|<|0.0001|TWO_SIDED|95.0|-8.22|-4.63|||MMRM||MMRM=baseline monthly migraine days as covariate, treatment group, visit, region and number of classes of failed prior treatments as fixed factors; treatment group and baseline-by-visit as interaction terms, with an unstructured covariance matrix.|||-4.63|-8.22|<0.0001
72588772|NCT03425396|144708575|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment difference|-3.5|||||TWO_SIDED|95.0|-16.8|9.6|||||Point estimate and exact 95% confidence intervals for difference from nitrofurantoin (omadacycline minus nitrofurantoin) in clinical success rate was estimated.|||9.6|-16.8|
72588773|NCT03425396|144708575|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment difference|-13.0|||||TWO_SIDED|95.0|-27.4|1.2|||||Point estimate and exact 95% confidence intervals for difference from nitrofurantoin (omadacycline minus nitrofurantoin) in clinical success rate was estimated.|||1.2|-27.4|
72588774|NCT03425396|144708575|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment difference|-5.6|||||TWO_SIDED|95.0|-19.6|7.4|||||Point estimate and exact 95% confidence intervals for difference from nitrofurantoin (omadacycline minus nitrofurantoin) in clinical success rate was estimated.|||7.4|-19.6|
72588775|NCT03425396|144708575|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment difference|-3.2|||||TWO_SIDED|95.0|-44.1|14.7|||||Point estimate and exact 95% confidence intervals for difference from nitrofurantoin (omadacycline minus nitrofurantoin) in clinical success rate was estimated.|||14.7|-44.1|
72588776|NCT03425396|144708576|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment difference|-1.6|||||TWO_SIDED|95.0|-14.3|11.2|||||Point estimate and exact 95% confidence intervals for difference from nitrofurantoin (omadacycline minus nitrofurantoin) in clinical success rate was estimated.|||11.2|-14.3|
72588777|NCT03425396|144708576|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment difference|-3.7|||||TWO_SIDED|95.0|-16.8|9.0|||||Point estimate and exact 95% confidence intervals for difference from nitrofurantoin (omadacycline minus nitrofurantoin) in clinical success rate was estimated.|||9.0|-16.8|
72588778|NCT03425396|144708576|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment difference|0.0|||||TWO_SIDED|95.0|-12.3|12.3|||||Point estimate and exact 95% confidence intervals for difference from nitrofurantoin (omadacycline minus nitrofurantoin) in clinical success rate was estimated.|||12.3|-12.3|
72588779|NCT03425396|144708576|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment difference|-3.2|||||TWO_SIDED|95.0|-44.1|14.7|||||Point estimate and exact 95% confidence intervals for difference from nitrofurantoin (omadacycline minus nitrofurantoin) in clinical success rate was estimated.|||14.7|-44.1|
72588780|NCT03425396|144708577|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment difference|-2.0|||||TWO_SIDED|95.0|-22.5|16.8|||||Point estimate and exact 95% confidence intervals for difference from nitrofurantoin (omadacycline minus nitrofurantoin) in clinical success rate was estimated.|||16.8|-22.5|
72588781|NCT03425396|144708577|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment difference|-4.7|||||TWO_SIDED|95.0|-23.3|14.2|||||Point estimate and exact 95% confidence intervals for difference from nitrofurantoin (omadacycline minus nitrofurantoin) in clinical success rate was estimated.|||14.2|-23.3|
72588782|NCT03425396|144708577|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment difference|5.7|||||TWO_SIDED|95.0|-13.0|22.6|||||Point estimate and exact 95% confidence intervals for difference from nitrofurantoin (omadacycline minus nitrofurantoin) in clinical success rate was estimated.|||22.6|-13.0|
72588783|NCT03425396|144708577|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment difference|10.0|||||TWO_SIDED|95.0|-40.4|28.9|||||Point estimate and exact 95% confidence intervals for difference from nitrofurantoin (omadacycline minus nitrofurantoin) in clinical success rate was estimated.|||28.9|-40.4|
72588784|NCT03425396|144708578|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment difference|1.7|||||TWO_SIDED|95.0|-10.0|13.4|||||Point estimate and exact 95% confidence intervals for difference from nitrofurantoin (omadacycline minus nitrofurantoin) in clinical success rate was estimated.|||13.4|-10.0|
72588785|NCT03425396|144708578|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%|Treatment difference|-2.9|||||TWO_SIDED|95.0|-16.2|9.7|||||Point estimate and exact 95% confidence intervals for difference from nitrofurantoin (omadacycline minus nitrofurantoin) in clinical success rate was estimated.|||9.7|-16.2|
72588786|NCT03425396|144708578|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%|Treatment Difference|7.7|||||TWO_SIDED|95.0|-0.3|18.5|||||Point estimate and exact 95% confidence intervals for difference from nitrofurantoin (omadacycline minus nitrofurantoin) in clinical success rate was estimated.|||18.5|-0.3|
72414119|NCT03086447|144337209|NON_INFERIORITY|A non-inferiority margin of -5 points was used. This margin is based on a 10% shift in the distribution of CLUE score.|Mean Difference (Final Values)|-3.1|STANDARD_DEVIATION|2.04|||TWO_SIDED|95.0|-7.2|0.9|||Linear mixed model|A 95% confidence interval for the least square mean difference was used to demonstrate non-inferiority of the Test relative to the Control groups.|Mean difference was calculated as Test minus Control|Sample size calculation was performed considering the effect size of 5 (Test minus Control) to achieve a minimum statistical power of 90% at a 5% significance level.||0.9|-7.2|
72588787|NCT03425396|144708578|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatm,ent difference|7.7|||||TWO_SIDED|95.0|-34.9|20.6|||||Point estimate and exact 95% confidence intervals for difference from nitrofurantoin (omadacycline minus nitrofurantoin) in clinical success rate was estimated.|||20.6|-34.9|
72588788|NCT03425396|144708579|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%|Treatment difference|0.0|||||TWO_SIDED|95.0|-12.6|12.6|||||Point estimate and exact 95% confidence intervals for difference from nitrofurantoin (omadacycline minus nitrofurantoin) in clinical success rate was estimated.|||12.6|-12.6|
72588789|NCT03425396|144708579|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment difference|-2.7|||||TWO_SIDED|95.0|-16.3|10.2|||||Point estimate and exact 95% confidence intervals for difference from nitrofurantoin (omadacycline minus nitrofurantoin) in clinical success rate was estimated.|||10.2|-16.3|
72588790|NCT03425396|144708579|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment difference|6.0|||||TWO_SIDED|95.0|-4.5|17.7|||||Point estimate and exact 95% confidence intervals for difference from nitrofurantoin (omadacycline minus nitrofurantoin) in clinical success rate was estimated|||17.7|-4.5|
72588791|NCT03425396|144708579|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment difference|8.2|||||TWO_SIDED|95.0|-35.3|20.7|||||Point estimate and exact 95% confidence intervals for difference from nitrofurantoin (omadacycline minus nitrofurantoin) in clinical success rate was estimated.|||20.7|-35.3|
72588792|NCT03425396|144708580|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%|Treatment difference|-6.0|||||TWO_SIDED|95.0|-27.3|13.3|||||Point estimate and exact 95% confidence intervals for difference from nitrofurantoin (omadacycline minus nitrofurantoin) in clinical success rate was estimated.|||13.3|-27.3|
72588793|NCT03425396|144708580|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment difference|-10.6|||||TWO_SIDED|95.0|-29.2|8.6|||||Point estimate and exact 95% confidence intervals for difference from nitrofurantoin (omadacycline minus nitrofurantoin) in clinical success rate was estimated.|||8.6|-29.2|
72588794|NCT03425396|144708580|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment Difference|1.3|||||TWO_SIDED|95.0|-19.0|19.2|||||Point estimate and exact 95% confidence intervals for difference from nitrofurantoin (omadacycline minus nitrofurantoin) in clinical success rate was estimated.|||19.2|-19.0|
72588795|NCT03425396|144708580|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment difference|10.0|||||TWO_SIDED|95.0|-40.4|28.9|||||Point estimate and exact 95% confidence intervals for difference from nitrofurantoin (omadacycline minus nitrofurantoin) in clinical success rate was estimated.|||28.9|-40.4|
72588796|NCT03425396|144708581|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment difference|-5.3|||||TWO_SIDED|95.0|-18.6|7.8|||||Point estimate and exact 95% confidence intervals for difference from nitrofurantoin (omadacycline minus nitrofurantoin) in clinical success rate was estimated.|||7.8|-18.6|
72588797|NCT03425396|144708581|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment difference|-14.8|||||TWO_SIDED|95.0|-29.6|-0.6|||||Point estimate and exact 95% confidence intervals for difference from nitrofurantoin (omadacycline minus nitrofurantoin) in clinical success rate was estimated.|||-0.6|-29.6|
72588798|NCT03425396|144708581|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment difference|-9.3|||||TWO_SIDED|95.0|-23.2|4.4|||||Point estimate and exact 95% confidence intervals for difference from nitrofurantoin (omadacycline minus nitrofurantoin) in clinical success rate was estimated.|||4.4|-23.2|
72588799|NCT03425396|144708581|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment difference|-3.2|||||TWO_SIDED|95.0|-44.1|14.7|||||Point estimate and exact 95% confidence intervals for difference from nitrofurantoin (omadacycline minus nitrofurantoin) in clinical success rate was estimated.|||14.7|-44.1|
72588800|NCT03425396|144708582|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment difference|-0.3|||||TWO_SIDED|95.0|-13.1|12.7|||||Point estimate and exact 95% confidence intervals for difference from nitrofurantoin (omadacycline minus nitrofurantoin) in clinical success rate was estimated.|||12.7|-13.1|
72588801|NCT03425396|144708582|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment difference|-5.8|||||TWO_SIDED|95.0|-20.7|7.8|||||Point estimate and exact 95% confidence intervals for difference from nitrofurantoin (omadacycline minus nitrofurantoin) in clinical success rate was estimated.|||7.8|-20.7|
72588802|NCT03425396|144708582|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment difference|-1.1|||||TWO_SIDED|95.0|-15.1|11.6|||||Point estimate and exact 95% confidence intervals for difference from nitrofurantoin (omadacycline minus nitrofurantoin) in clinical success rate was estimated.|||11.6|-15.1|
72588803|NCT03425396|144708582|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment difference|8.2|||||TWO_SIDED|95.0|-35.3|20.7|||||Point estimate and exact 95% confidence intervals for difference from nitrofurantoin (omadacycline minus nitrofurantoin) in clinical success rate was estimated.|||20.7|-35.3|
72588804|NCT03425396|144708583|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment difference|-6.0|||||TWO_SIDED|95.0|-27.3|13.3|||||Point estimate and exact 95% confidence intervals for difference from nitrofurantoin (omadacycline minus nitrofurantoin) in clinical success rate was estimated|||13.3|-27.3|
72414120|NCT03086447|144337210|NON_INFERIORITY|A non-inferiority margin of 0.5 was used. This margin is based on a 10% difference in the distribution between the Test and Control groups.|Odds Ratio (OR)|1.77|||||TWO_SIDED|95.0|0.98|3.22|||Generalized LMM w/ binomial dist.||Odds ratio of Test over Control was calculated.|Proportion of eyes with optimal VA assessed at fitting in the Test group was compared to the Control group.||3.22|0.98|
72414121|NCT05437510|144337238|SUPERIORITY||Efficacy|84.04|||<|0.0001|TWO_SIDED|95.0|69.493|92.411|||Exact method using binomial distribution|||The 2-sided 95% confidence interval (CI) for the efficacy was calculated by an exact method assuming a binomial distribution of the number of RSV LRTI hospitalizations in the nirsevimab group conditional on the total number in both groups accounting for the follow-up time post-dosing/randomization.||92.411|69.493|<0.0001
72414122|NCT05437510|144337239|SUPERIORITY||Efficacy|77.71||||0.0014|TWO_SIDED|95.0|39.249|93.432|||Exact method using binomial distribution|||The 2-sided 95% CI for the efficacy was calculated by an exact method assuming a binomial distribution of the number of very severe RSV LRTI in the nirsevimab group conditional on the total number in both groups accounting for the follow-up time post-dosing/randomization.||93.432|39.249|0.0014
72414123|NCT05437510|144337240|SUPERIORITY||Efficacy|90.7|||<|0.0001|TWO_SIDED|95.0|63.676|98.813||Adjusted p-value is reported.|Exact method using binomial distribution|||Statistical analysis for France: The adjusted 2-sided 95% CI for the efficacy was calculated by an exact method assuming a binomial distribution of the number of RSV LRTI hospitalizations in the nirsevimab group conditional on the total number in both groups accounting for the follow-up time post-dosing/randomization. Adjustment based on Bonferroni-Holm procedure.||98.813|63.676|<0.0001
72414124|NCT05437510|144337240|SUPERIORITY||Efficacy|83.2||||0.0036|TWO_SIDED|95.0|33.589|97.593||Adjusted p-value is reported.|Exact method using binomial distribution|||Statistical analysis for UK: The adjusted 2-sided 95% CI for the efficacy was calculated by an exact method assuming a binomial distribution of the number of RSV LRTI hospitalizations in the nirsevimab group conditional on the total number in both groups accounting for the follow-up time post-dosing/randomization. Adjustment based on Bonferroni-Holm procedure.||97.593|33.589|0.0036
72414125|NCT05437510|144337240|SUPERIORITY||Efficacy|74.62||||0.0051|TWO_SIDED|95.0|29.74|92.595||Adjusted p-value is reported.|Exact method using binomial distribution|||Statistical analysis for Germany: The adjusted 2-sided 95% CI for the efficacy was calculated by an exact method assuming a binomial distribution of the number of RSV LRTI hospitalizations in the nirsevimab group conditional on the total number in both groups accounting for the follow-up time post-dosing/randomization. Adjustment based on Bonferroni-Holm procedure.||92.595|29.740|0.0051
72588805|NCT03425396|144708583|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment difference|-13.5|||||TWO_SIDED|95.0|-32.4|5.9|||||Point estimate and exact 95% confidence intervals for difference from nitrofurantoin (omadacycline minus nitrofurantoin) in clinical success rate was estimated|||5.9|-32.4|
72588806|NCT03425396|144708583|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment difference|-3.0|||||TWO_SIDED|95.0|-25.7|15.6|||||Point estimate and exact 95% confidence intervals for difference from nitrofurantoin (omadacycline minus nitrofurantoin) in clinical success rate was estimated|||15.6|-25.7|
72588807|NCT03425396|144708583|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment difference|10.0|||||TWO_SIDED|95.0|-40.4|28.9|||||Point estimate and exact 95% confidence intervals for difference from nitrofurantoin (omadacycline minus nitrofurantoin) in clinical success rate was estimated|||28.9|-40.4|
72588808|NCT03425396|144708584|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment difference|-21.3|||||TWO_SIDED|95.0|-44.1|-1.0|||||Point estimate and exact 95% confidence intervals for difference from nitrofurantoin (omadacycline minus nitrofurantoin) in clinical success rate was estimated.|||-1.0|-44.1|
72414126|NCT05437510|144337241|SUPERIORITY||Efficacy|57.97|||<|0.0001|TWO_SIDED|95.0|40.36|70.76|||Exact method using binomial distribution|||"Statistical analysis for Overall:~The 2-sided 95% CI for the efficacy was calculated by an exact method assuming a binomial distribution of the number of all-cause LRTI hospitalizations in the nirsevimab group conditional on the total number in both groups accounting for the follow-up time post-dosing/randomization."||70.760|40.360|<0.0001
72414127|NCT05437510|144337241|SUPERIORITY||Efficacy|52.48||||0.0039|TWO_SIDED|95.0|20.121|72.36|||Exact method using binomial distribution|||"Statistical analysis for France:~The 2-sided 95% CI for the efficacy was calculated by an exact method assuming a binomial distribution of the number of all-cause LRTI hospitalizations in the nirsevimab group conditional on the total number in both groups accounting for the follow-up time post-dosing/randomization."||72.360|20.121|0.0039
72588809|NCT03425396|144708584|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment difference|-13.9|||||TWO_SIDED|95.0|-32.2|4.9|||||Point estimate and exact 95% confidence intervals for difference from nitrofurantoin (omadacycline minus nitrofurantoin) in clinical success rate was estimated.|||4.9|-32.2|
72588810|NCT03425396|144708584|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment difference|-19.4|||||TWO_SIDED|95.0|-43.1|1.1|||||Point estimate and exact 95% confidence intervals for difference from nitrofurantoin (omadacycline minus nitrofurantoin) in clinical success rate was estimated.|||1.1|-43.1|
72588811|NCT03425396|144708584|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment difference|6.7|||||TWO_SIDED|95.0|-43.8|23.2|||||Point estimate and exact 95% confidence intervals for difference from nitrofurantoin (omadacycline minus nitrofurantoin) in clinical success rate was estimated.|||23.2|-43.8|
72588812|NCT03425396|144708585|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment difference|-14.7|||||TWO_SIDED|95.0|-37.2|3.1|||||Point estimate and exact 95% confidence intervals for difference from nitrofurantoin (omadacycline minus nitrofurantoin) in clinical success rate was estimated.|||3.1|-37.2|
72588813|NCT03425396|144708585|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment difference|-15.9|||||TWO_SIDED|95.0|-34.3|1.2|||||Point estimate and exact 95% confidence intervals for difference from nitrofurantoin (omadacycline minus nitrofurantoin) in clinical success rate was estimated.|||1.2|-34.3|
72588814|NCT03425396|144708585|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment difference|-23.8|||||TWO_SIDED|95.0|-46.9|-4.3|||||Point estimate and exact 95% confidence intervals for difference from nitrofurantoin (omadacycline minus nitrofurantoin) in clinical success rate was estimated.|||-4.3|-46.9|
72588815|NCT03425396|144708585|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment difference|3.4|||||TWO_SIDED|95.0|-48.5|19.7|||||Point estimate and exact 95% confidence intervals for difference from nitrofurantoin (omadacycline minus nitrofurantoin) in clinical success rate was estimated.|||19.7|-48.5|
72588816|NCT03425396|144708586|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment difference|-20.7|||||TWO_SIDED|95.0|-45.1|6.0|||||Point estimate and exact 95% confidence intervals for difference from nitrofurantoin (omadacycline minus nitrofurantoin) in clinical success rate was estimated.|||6.0|-45.1|
72588817|NCT03425396|144708586|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment difference|-17.8|||||TWO_SIDED|95.0|-40.2|5.9|||||Point estimate and exact 95% confidence intervals for difference from nitrofurantoin (omadacycline minus nitrofurantoin) in clinical success rate was estimated.|||5.9|-40.2|
72588818|NCT03425396|144708586|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment difference|-11.4|||||TWO_SIDED|95.0|-36.8|14.7|||||Point estimate and exact 95% confidence intervals for difference from nitrofurantoin (omadacycline minus nitrofurantoin) in clinical success rate was estimated.|||14.7|-36.8|
72588819|NCT03425396|144708586|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment difference|3.3|||||TWO_SIDED|95.0|-47.0|33.2|||||Point estimate and exact 95% confidence intervals for difference from nitrofurantoin (omadacycline minus nitrofurantoin) in clinical success rate was estimated.|||33.2|-47.0|
72588820|NCT03425396|144708587|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment difference|-13.6|||||TWO_SIDED|95.0|-40.4|13.2|||||Point estimate and exact 95% confidence intervals for difference from nitrofurantoin (omadacycline minus nitrofurantoin) in clinical success rate was estimated.|||13.2|-40.4|
72588821|NCT03425396|144708587|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment difference|-9.6|||||TWO_SIDED|95.0|-32.7|14.6|||||Point estimate and exact 95% confidence intervals for difference from nitrofurantoin (omadacycline minus nitrofurantoin) in clinical success rate was estimated.|||14.6|-32.7|
72588822|NCT03425396|144708587|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment difference|-11.9|||||TWO_SIDED|95.0|-38.2|14.9|||||Point estimate and exact 95% confidence intervals for difference from nitrofurantoin (omadacycline minus nitrofurantoin) in clinical success rate was estimated.|||14.9|-38.2|
72588823|NCT03425396|144708587|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment difference|1.4|||||TWO_SIDED|95.0|-50.3|30.9|||||Point estimate and exact 95% confidence intervals for difference from nitrofurantoin (omadacycline minus nitrofurantoin) in clinical success rate was estimated.|||30.9|-50.3|
72588824|NCT03689374|144708627|NON_INFERIORITY|The responses were analyzed using an ANCOVA with treatment as fixed factor and baseline value as a covariate. Before analysis, missing data were multiple imputed using observed data from participants within the same group defined by randomized treatment, using a regression model including randomized treatment group and data from baseline and all previous visits as covariates. The prespecified non inferiority margin was 0.3%-point.|Treatment difference|-0.29|||<|0.0001|TWO_SIDED|95.0|-0.38|-0.2|||t-distributed test|The non-inferiority p-value was calculated as two times the one-sided p-value from a t-distributed test.||||-0.20|-0.38|<0.0001
72588825|NCT02805660|144708664|SUPERIORITY|An exact test for single proportion was performed to test null hypothesis (H0): ORR \<= 5% against alternative hypothesis (H1): ORR \> 5% for Cohorts 1, 3, and 4 and to test H0: ORR \<= 27% against H1: ORR \> 27% for Cohort 2.||||||0.537|||||||Exact Test|||||||0.537
72588826|NCT02805660|144708664|SUPERIORITY|An exact test for single proportion was performed to test null hypothesis (H0): ORR \<= 5% against alternative hypothesis (H1): ORR \> 5% for Cohorts 1, 3, and 4 and to test H0: ORR \<= 27% against H1: ORR \> 27% for Cohort 2.|||||>|0.999|||||||Exact Test|||||||>0.999
72588827|NCT02805660|144708664|SUPERIORITY|An exact test for single proportion was performed to test null hypothesis (H0): ORR \<= 5% against alternative hypothesis (H1): ORR \> 5% for Cohorts 1, 3, and 4 and to test H0: ORR \<= 27% against H1: ORR \> 27% for Cohort 2.||||||0.283|||||||Exact Test|||||||0.283
72588828|NCT02805660|144708664|SUPERIORITY|An exact test for single proportion was performed to test null hypothesis (H0): ORR \<= 5% against alternative hypothesis (H1): ORR \> 5% for Cohorts 1, 3, and 4 and to test H0: ORR \<= 27% against H1: ORR \> 27% for Cohort 2.||||||0.025|||||||Exact Test|||||||0.025
72588829|NCT01314872|144708677|SUPERIORITY_OR_OTHER||Difference in least squares (LS) means|-0.46||||0.056|TWO_SIDED|95.0|-0.92|0.01|||Constrained Longitudinal Data Analysis|Constrained longitudinal data analysis model includes terms for time, region, part and interaction of time by treatment.||||0.01|-0.92|0.056
72588830|NCT01314872|144708677|SUPERIORITY_OR_OTHER||Difference in LS means|-0.45||||0.064|TWO_SIDED|95.0|-0.93|0.03|||Constrained Longitudinal Data Analysis|Constrained longitudinal data analysis model includes terms for time, region, part and interaction of time by treatment.||||0.03|-0.93|0.064
72588831|NCT01314872|144708677|SUPERIORITY_OR_OTHER||Difference in LS means|-0.64||||0.007|TWO_SIDED|95.0|-1.11|-0.18|||Constrained Longitudinal Data Analysis|Constrained longitudinal data analysis model includes terms for time, region, part and interaction of time by treatment.||||-0.18|-1.11|0.007
72588832|NCT01314872|144708677|SUPERIORITY_OR_OTHER||Difference in LS means|-0.91|||<|0.001|TWO_SIDED|95.0|-1.37|-0.44|||Constrained Longitudinal Data Analysis|Constrained longitudinal data analysis model includes terms for time, region, part and interaction of time by treatment.||||-0.44|-1.37|< 0.001
72588833|NCT01314872|144708677|SUPERIORITY_OR_OTHER||Difference in LS means|-0.54||||0.026|TWO_SIDED|95.0|-1.02|-0.07|||Constrained Longitudinal Data Analysis|Constrained longitudinal data analysis model includes terms for time, region, part and interaction of time by treatment.||||-0.07|-1.02|0.026
72588834|NCT01314872|144708682|SUPERIORITY_OR_OTHER||Difference in LS means|-0.28||||0.167|TWO_SIDED|95.0|-0.68|0.12|||Constrained Longitudinal Data Analysis|Constrained longitudinal data analysis model includes terms for time, region, and interaction of time by treatment.||||0.12|-0.68|0.167
72588835|NCT01314872|144708682|SUPERIORITY_OR_OTHER||Difference in LS means|-0.57||||0.005|TWO_SIDED|95.0|-0.97|-0.17|||Constrained Longitudinal Data Analysis|Constrained longitudinal data analysis model includes terms for time, region, and interaction of time by treatment.||||-0.17|-0.97|0.005
72588836|NCT01314872|144708682|SUPERIORITY_OR_OTHER||Difference in LS means|-0.72|||<|0.001|TWO_SIDED|95.0|-1.11|-0.33|||Constrained Longitudinal Data Analysis|Constrained longitudinal data analysis model includes terms for time, region, and interaction of time by treatment.||||-0.33|-1.11|< 0.001
72588837|NCT01314872|144708682|SUPERIORITY_OR_OTHER||Difference in LS means|-0.71|||<|0.001|TWO_SIDED|95.0|-1.1|-0.32|||Constrained Longitudinal Data Analysis|Constrained longitudinal data analysis model includes terms for time, region, and interaction of time by treatment.||||-0.32|-1.10|< 0.001
72588838|NCT01314872|144708682|SUPERIORITY_OR_OTHER||Difference in LS means|-0.46||||0.03|TWO_SIDED|95.0|-0.87|-0.04|||Constrained Longitudinal Data Analysis|Constrained longitudinal data analysis model includes terms for time, region, and interaction of time by treatment.||||-0.04|-0.87|0.030
72588839|NCT01314872|144708683|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.18||||0.401|TWO_SIDED|95.0|-0.61|0.25|||Constrained Longitudinal Data Analysis|Constrained longitudinal data analysis model includes terms for time, region, and interaction of time by treatment.||||0.25|-0.61|0.401
72588840|NCT01314872|144708683|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.48||||0.029|TWO_SIDED|95.0|-0.91|-0.05|||Constrained Longitudinal Data Analysis|Constrained longitudinal data analysis model includes terms for time, region, and interaction of time by treatment.||||-0.05|-0.91|0.029
72588841|NCT01314872|144708683|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.6||||0.005|TWO_SIDED|95.0|-1.02|-0.18|||Constrained Longitudinal Data Analysis|Constrained longitudinal data analysis model includes terms for time, region, and interaction of time by treatment.||||-0.18|-1.02|0.005
72588842|NCT01314872|144708683|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.58||||0.007|TWO_SIDED|95.0|-1.01|-0.16|||Constrained Longitudinal Data Analysis|Constrained longitudinal data analysis model includes terms for time, region, and interaction of time by treatment.||||-0.16|-1.01|0.007
72588843|NCT01314872|144708683|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.34||||0.14|TWO_SIDED|95.0|-0.78|0.11|||Constrained Longitudinal Data Analysis|Constrained longitudinal data analysis model includes terms for time, region, and interaction of time by treatment.||||0.11|-0.78|0.140
72588844|NCT01314872|144708684|SUPERIORITY_OR_OTHER||Difference in LS means|-0.18||||0.598|TWO_SIDED|95.0|-0.84|0.49|||Constrained Longitudinal Data Analysis|Constrained longitudinal data analysis model includes terms for time, region, and interaction of time by treatment.||||0.49|-0.84|0.598
72588845|NCT01314872|144708684|SUPERIORITY_OR_OTHER||Difference in LS means|-0.67||||0.052|TWO_SIDED|95.0|-1.35|0.01|||Constrained Longitudinal Data Analysis|Constrained longitudinal data analysis model includes terms for time, region, and interaction of time by treatment.||||0.01|-1.35|0.052
72588846|NCT01314872|144708684|SUPERIORITY_OR_OTHER||Difference in LS means|-0.76||||0.024|TWO_SIDED|95.0|-1.43|-0.1|||Constrained Longitudinal Data Analysis|Constrained longitudinal data analysis model includes terms for time, region, and interaction of time by treatment.||||-0.10|-1.43|0.024
72588847|NCT01314872|144708684|SUPERIORITY_OR_OTHER||Difference in LS means|-1.24|||<|0.001|TWO_SIDED|95.0|-1.9|-0.58|||Constrained Longitudinal Data Analysis|Constrained longitudinal data analysis model includes terms for time, region, and interaction of time by treatment.||||-0.58|-1.90|< 0.001
72588848|NCT01314872|144708684|SUPERIORITY_OR_OTHER||Difference in LS means|-0.94||||0.007|TWO_SIDED|95.0|-1.62|-0.26|||Constrained Longitudinal Data Analysis|Constrained longitudinal data analysis model includes terms for time, region, and interaction of time by treatment.||||-0.26|-1.62|0.007
72588849|NCT01314872|144708685|SUPERIORITY_OR_OTHER||Difference in LS means|-0.49|||||TWO_SIDED|95.0|-1.0|0.03||||||||0.03|-1.00|
72588850|NCT01314872|144708685|SUPERIORITY_OR_OTHER||Difference in LS means|-1.1|||||TWO_SIDED|95.0|-1.62|-0.58||||||||-0.58|-1.62|
72588851|NCT01314872|144708686|SUPERIORITY_OR_OTHER||Difference in LS means|-0.29|||||TWO_SIDED|95.0|-0.71|0.13||||||||0.13|-0.71|
72588852|NCT01314872|144708686|SUPERIORITY_OR_OTHER||Difference in LS means|-0.21|||||TWO_SIDED|95.0|-0.64|0.21||||||||0.21|-0.64|
72588853|NCT01314872|144708687|SUPERIORITY_OR_OTHER||Difference in LS means|-0.07|||||TWO_SIDED|95.0|-0.56|0.43||||||||0.43|-0.56|
72588854|NCT01314872|144708687|SUPERIORITY_OR_OTHER||Difference in LS means|0.02|||||TWO_SIDED|95.0|-0.48|0.51||||||||0.51|-0.48|
72588855|NCT01314872|144708688|SUPERIORITY_OR_OTHER||Difference in LS means|-0.76|||||TWO_SIDED|95.0|-1.45|-0.08||||||||-0.08|-1.45|
72588856|NCT01314872|144708688|SUPERIORITY_OR_OTHER||Difference in LS means|-1.24|||||TWO_SIDED|95.0|-1.93|-0.56||||||||-0.56|-1.93|
72588857|NCT04532619|144708689|SUPERIORITY||Slope|0.5||||0.014|TWO_SIDED|95.0|0.1|0.89||Computed p-value|Mixed Models Analysis|||We used a multilevel models to produce regression estimates. We used multiple imputation. Intervention enrollment was coded as 1 and enrollment in the control arm was coded as 0. We accounted for baseline values and psychopathology.||0.89|0.10|0.014
72588858|NCT04532619|144708690|SUPERIORITY||Slope|-0.05||||0.8|TWO_SIDED|95.0|-0.41|0.32||computed p-value|Mixed Models Analysis|||We used a multilevel models to produce regression estimates. We used multiple imputation. Intervention enrollment was coded as 1 and enrollment in the control arm was coded as 0. We accounted for baseline values and psychopathology.||0.32|-0.41|0.80
72588859|NCT04532619|144708691|SUPERIORITY||Slope|-0.29||||0.009|TWO_SIDED|95.0|-0.51|-0.07||computed p-value|Mixed Models Analysis|||We used a multilevel models to produce regression estimates. We used multiple imputation. Intervention enrollment was coded as 1 and enrollment in the control arm was coded as 0. We accounted for baseline values and psychopathology.||-0.07|-0.51|0.009
72588860|NCT04532619|144708692|SUPERIORITY||Slope|0.17||||0.118|TWO_SIDED|95.0|-0.04|0.38||calculated p-value|Mixed Models Analysis|||We used a multilevel models to produce regression estimates. We used multiple imputation. Intervention enrollment was coded as 1 and enrollment in the control arm was coded as 0. We accounted for baseline values and psychopathology.||0.38|-0.04|0.118
72588861|NCT04532619|144708693|SUPERIORITY||Odds Ratio, log|-0.9|STANDARD_ERROR_OF_MEAN|0.77||0.24|TWO_SIDED|||||computed p-value|Mixed Models Analysis|||We used a multilevel models to produce regression estimates. We used multiple imputation. Intervention enrollment was coded as 1 and enrollment in the control arm was coded as 0. We accounted for baseline values and psychopathology. A logistic link function was used for this binary outcome.||||.24
72588862|NCT04532619|144708694|SUPERIORITY||Slope|-1.33||||0.43|TWO_SIDED|95.0|-4.64|1.98||computed p-value|Mixed Models Analysis|||We used a multilevel models to produce regression estimates. We used multiple imputation. Intervention enrollment was coded as 1 and enrollment in the control arm was coded as 0. We accounted for baseline values and psychopathology.||1.98|-4.64|0.43
72588863|NCT04532619|144708695|SUPERIORITY||Slope|-2.06||||0.07|TWO_SIDED|95.0|-4.27|0.15||computed p-value|Mixed Models Analysis|||We used a multilevel models to produce regression estimates. We used multiple imputation. Intervention enrollment was coded as 1 and enrollment in the control arm was coded as 0. We accounted for baseline values and psychopathology.||0.15|-4.27|0.07
72588864|NCT01435018|144708698|NON_INFERIORITY|"Non-inferiority is defined as demonstrating that the 48-week PFS rate in ET+ART is within 15 percent of PTX+ART. The selection of the 15 percent non-inferiority margin was a combination of clinical judgment and statistical reasoning. A poll of the sites was conducted to derive the maximum treatment difference that is considered clinically relevant (i.e. largest acceptable difference in order to gain the advantages (e.g. cost) of the experimental chemotherapy)."|Cumulative rate difference|-30.3|||||TWO_SIDED|95.0|-52.3|-8.3|||||Confidence interval (CI) estimation was stratified by screening CD4 count using Greenwood's variance with the inverse of this variance used for the stratum weights. CI stratified by country was not performed due to small number of observations.|Treatment comparison was made using the difference (ET+ART - PTX+ART) in the stratified Kaplan-Meier estimate for the week 48 PFS rate with 95% two-sided confidence interval.||-8.3|-52.3|
72588865|NCT01435018|144708699|NON_INFERIORITY|"Non-inferiority is defined as demonstrating that the 48-week PFS rate in BV+ART is within 15 percent of PTX+ART. The selection of the 15 percent non-inferiority margin was a combination of clinical judgment and statistical reasoning. A poll of the sites was conducted to derive the maximum treatment difference that is considered clinically irrelevant (i.e. largest acceptable difference in order to gain the advantages (e.g. cost) of the experimental chemotherapy)."|Cumulative rate difference|-19.8|||||TWO_SIDED|95.0|-32.3|-7.4|||||Confidence interval estimation was stratified by screening CD4 count using Greenwood's variance with the inverse of this variance used for the stratum weights.|Treatment comparison was made using the difference (BV+ART - PTX+ART) in the stratified Kaplan-Meier estimate for the week 48 PFS rate with 95% two-sided confidence interval.||-7.4|-32.3|
72588866|NCT01435018|144708699|NON_INFERIORITY|"Non-inferiority is defined as demonstrating that the 48-week PFS rate in BV+ART is within 15 percent of PTX+ART. The selection of the 15 percent non-inferiority margin was a combination of clinical judgment and statistical reasoning. A poll of the sites was conducted to derive the maximum treatment difference that is considered clinically irrelevant (i.e. largest acceptable difference in order to gain the advantages (e.g. cost) of the experimental chemotherapy)."|Cumulative rate difference|-20.1|||||TWO_SIDED|95.0|-32.2|-7.9|||||Confidence interval estimation was stratified by country using Greenwood's variance with the inverse of this variance used for the stratum weights.|Treatment comparison was made using the difference (BV+ART - PTX+ART) in the stratified Kaplan-Meier estimate for the week 48 cumulative PFS rate with 95% two-sided confidence interval.||-7.9|-32.2|
72588867|NCT01435018|144708700|OTHER||Cumulative rate difference|14.7|||||TWO_SIDED|95.0|-1.9|31.4|||||Confidence interval estimation was stratified by screening CD4 lymphocyte count using Greenwood's variance with the inverse of this variance used for the stratum weights.|Treatment comparison was made using the difference (ET+ART - PTX+ART) in the stratified Kaplan-Meier estimate for the week 48 cumulative rate of death with 95% two-sided confidence interval.||31.4|-1.9|
72588868|NCT01435018|144708701|OTHER||Cumulative rate difference|8.4|||||TWO_SIDED|95.0|-0.4|17.2|||||Confidence interval estimation was stratified by screening CD4 count using Greenwood's variance with the inverse of this variance used for the stratum weights.|Treatment comparison was made using the difference (BV+ART - PTX+ART) in the stratified Kaplan-Meier estimate for the week 48 cumulative rate of death with 95% two-sided confidence interval.||17.2|-0.4|
72588869|NCT01435018|144708703|OTHER||Cumulative rate difference|16.3|||||TWO_SIDED|95.0|3.7|28.8||||||Treatment comparison was made using the difference (BV+ART - PTX+ART) in the stratified Kaplan-Meier estimate for the week 48 cumulative rate of IERC-confirmed KS progression with 95% two-sided confidence interval.|Confidence interval estimation was stratified by screening CD4 lymphocyte count using Greenwood's variance with the inverse of this variance used for the stratum weights.|28.8|3.7|
72588870|NCT01435018|144708704|OTHER||Cumulative rate difference|-15.0|||||TWO_SIDED|95.0|-34.4|4.3|||||Confidence interval estimation was stratified by screening CD4 lymphocyte count using Greenwood's variance with the inverse of this variance used for the stratum weights.|Treatment comparison was made using the difference (ET+ART - PTX+ART) in the stratified Kaplan-Meier estimate for the week 48 cumulative rate of AIDS-defining events with 95% two-sided confidence interval.||4.3|-34.4|
72588871|NCT01435018|144708705|OTHER||Cumulative rate difference|-3.3|||||TWO_SIDED|95.0|-13.3|6.6|||||Confidence interval estimation was stratified by screening CD4 lymphocyte count using Greenwood's variance with the inverse of this variance used for the stratum weights.|Treatment comparison was made using the difference (BV+ART - PTX+ART) in the stratified Kaplan-Meier estimate for the week 48 cumulative rate of AIDS-defining events with 95% two-sided confidence interval.||6.6|-13.3|
72588872|NCT01435018|144708706|OTHER||Cumulative rate difference|4.3|||||TWO_SIDED|95.0|-1.9|10.6|||||Confidence interval estimation was stratified by screening CD4 lymphocyte count using Greenwood's variance with the inverse of this variance used for the stratum weights.|Treatment comparison was made using the difference (ET+ART - PTX+ART) in the stratified Kaplan-Meier estimate for the week 48 cumulative rate of HIV-1 RNA virologic failure with 95% two-sided confidence interval.||10.6|-1.9|
72588873|NCT01435018|144708707|OTHER||Cumulative rate difference|5.5|||||TWO_SIDED|95.0|-0.1|11.0|||||Confidence interval estimation was stratified by screening CD4 lymphocyte count using Greenwood's variance with the inverse of this variance used for the stratum weights.|Treatment comparison was made using the difference (BV+ART - PTX+ART) in the stratified Kaplan-Meier estimate for the week 48 cumulative rate of HIV-1 RNA virologic failure with 95% two-sided confidence interval.||11.0|-0.1|
72588874|NCT01435018|144708710|OTHER||Cumulative rate difference|19.4|||||TWO_SIDED|95.0|-4.1|43.0|||||Confidence interval estimation was stratified by screening CD4 lymphocyte count using Greenwood's variance with the inverse of this variance used for the stratum weights.|Treatment comparison was made using the difference (ET+ART - PTX+ART) in the stratified Kaplan-Meier estimate for the week 48 cumulative rate of KS progression, death, or AIDS defining event.||43.0|-4.1|
72588875|NCT01435018|144708711|OTHER||Cumulative rate difference|14.4|||||TWO_SIDED|95.0|1.8|27.0|||||Confidence interval estimation was stratified by screening CD4 lymphocyte count using Greenwood's variance with the inverse of this variance used for the stratum weights.|Treatment comparison was made using the difference (BV+ART - PTX+ART) in the stratified Kaplan-Meier estimate for the week 48 cumulative rate of KS progression, death, or AIDS defining event.||27.0|1.8|
72588876|NCT01435018|144708712|OTHER||Cumulative rate difference|24.2|||||TWO_SIDED|95.0|0.9|47.4|||||Confidence interval estimation was stratified by screening CD4 lymphocyte count using Greenwood's variance with the inverse of this variance used for the stratum weights.|Treatment comparison was made using the difference (ET+ART - PTX+ART) in the stratified Kaplan-Meier estimate for the week 48 cumulative rate of KS progression, death, AIDS defining event, or virologic failure.||47.4|0.9|
72414128|NCT05437510|144337241|SUPERIORITY||Efficacy|58.62||||0.0024|TWO_SIDED|95.0|25.115|78.049|||Exact method using binomial distribution|||"Statistical analysis for UK:~The 2-sided 95% CI for the efficacy was calculated by an exact method assuming a binomial distribution of the number of all-cause LRTI hospitalizations in the nirsevimab group conditional on the total number in both groups accounting for the follow-up time post-dosing/randomization."||78.049|25.115|0.0024
72414129|NCT05437510|144337241|SUPERIORITY||Efficacy|70.74||||0.0037|TWO_SIDED|95.0|29.567|89.396|||Exact method using binomial distribution|||"Statistical analysis for Germany:~The 2-sided 95% CI for the efficacy was calculated by an exact method assuming a binomial distribution of the number of all-cause LRTI hospitalizations in the nirsevimab group conditional on the total number in both groups accounting for the follow-up time post-dosing/randomization."||89.396|29.567|0.0037
72588877|NCT01435018|144708713|OTHER||Cumulative rate difference|18.8|||||TWO_SIDED|95.0|6.3|31.3|||||Confidence interval estimation was stratified by screening CD4 lymphocyte count using Greenwood's variance with the inverse of this variance used for the stratum weights.|Treatment comparison was made using the difference (BV+ART - PTX+ART) in the stratified Kaplan-Meier estimate for the week 48 cumulative rate of KS progression, death, AIDS defining event, or virologic failure.||31.3|6.3|
72588878|NCT01435018|144708714|OTHER||Cumulative rate difference|24.2|||||TWO_SIDED|95.0|0.9|47.4|||||Confidence interval estimation was stratified by screening CD4 lymphocyte count using Greenwood's variance with the inverse of this variance used for the stratum weights.|Treatment comparison was made using the difference (ET+ART - PTX+ART) in the stratified Kaplan-Meier estimate for the week 48 cumulative rate of KS progression, death, AIDS defining event, virologic failure, or KS-IRIS.||47.4|0.9|
72588879|NCT01435018|144708715|OTHER||Cumulative rate difference|17.7|||||TWO_SIDED|95.0|6.2|29.3|||||Confidence interval estimation was stratified by screening CD4 lymphocyte count using Greenwood's variance with the inverse of this variance used for the stratum weights.|Treatment comparison was made using the difference (BV+ART - PTX+ART) in the stratified Kaplan-Meier estimate for the week 48 cumulative rate of KS progression, death, AIDS defining event, virologic failure, or KS-IRIS.||29.3|6.2|
72588880|NCT01435018|144708716|OTHER||Cumulative rate difference|37.5|||||TWO_SIDED|95.0|13.6|61.4|||||Confidence interval estimation was stratified by screening CD4 lymphocyte count using Greenwood's variance with the inverse of this variance used for the stratum weights.|Treatment comparison was made using the difference (ET+ART - PTX+ART) in the stratified Kaplan-Meier estimate for the week 48 cumulative rate of change in KS treatment.||61.4|13.6|
72588881|NCT01435018|144708717|OTHER||Cumulative rate difference|11.1|||||TWO_SIDED|95.0|-0.4|22.7|||||Confidence interval estimation was stratified by screening CD4 lymphocyte count using Greenwood's variance with the inverse of this variance used for the stratum weights.|Treatment comparison was made using the difference (BV+ART - PTX+ART) in the stratified Kaplan-Meier estimate for the week 48 cumulative rate of change in KS treatment.||22.7|-0.4|
72588882|NCT01435018|144708718|OTHER||Cumulative rate difference|14.7|||||TWO_SIDED|95.0|-1.9|31.4|||||Confidence interval estimation was stratified by screening CD4 lymphocyte count using Greenwood's variance with the inverse of this variance used for the stratum weights.|Treatment comparison was made using the difference (ET+ART - PTX+ART) in the stratified Kaplan-Meier estimate for the cumulative rate of death with 95% two-sided confidence interval.||31.4|-1.9|
72588883|NCT01435018|144708719|OTHER||Cumulative rate difference|8.4|||||TWO_SIDED|95.0|-0.4|17.2|||||Confidence interval estimation was stratified by screening CD4 lymphocyte count using Greenwood's variance with the inverse of this variance used for the stratum weights.|Treatment comparison was made using the difference (BV+ART - PTX+ART) in the stratified Kaplan-Meier estimate for the cumulative rate of death with 95% two-sided confidence interval.||17.2|-0.4|
72588884|NCT01435018|144708720|OTHER||Hazard Ratio (HR)|1.9|||||TWO_SIDED|95.0|1.1|3.4|||||Hazard ratio for ET+ART relative to PTX+ART adjusted for screening CD4 lymphocyte count.|||3.4|1.1|
72588885|NCT01435018|144708721|OTHER||Hazard Ratio (HR)|1.5|||||TWO_SIDED|95.0|1.1|2.2|||||Hazard ratio for BV+ART relative to PTX+ART adjusted for screening CD4 lymphocyte count.|||2.2|1.1|
72588886|NCT01435018|144708722|OTHER||Odds Ratio (OR)|0.3|||||TWO_SIDED|95.0|0.1|0.7|||||Odds ratio for ET+ART relative to PTX+ART adjusted for screening CD4 lymphocyte count.|||0.7|0.1|
72588887|NCT01435018|144708723|OTHER||Odds Ratio (OR)|0.8|||||TWO_SIDED|95.0|0.5|1.3|||||Odds ratio for BV+ART relative to PTX+ART adjusted for screening CD4 lymphocyte count and country.|||1.3|0.5|
72588888|NCT00769067|144708749|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.657||||0.012|TWO_SIDED|95.0|0.472|0.914||2-Sided.|Log Rank|Adjusted for the stratification factors: EGFR status, KRAS status and baseline ECOG performance status.|The estimated HR was for the Dacomitinib arm versus the Erlotinib arm.|"Total 128 events (progression/death) provided 80% power to detect a hazard ratio (HR) of 1.45 (Erlotinib versus Dacomitinib arm) with 1-sided alpha=0.10.This represented a 45% improvement in true median PFS.~HR and 95% confidence interval estimated from stratified Cox Regression;2-sided p-value was based on stratified log-rank test with epidermal growth factor receptor (EGFR) status, Kirsten Rat Sarcoma status (KRAS), baseline Eastern Cooperative Oncology Group (ECOG) as stratification factors"||0.914|0.472|0.012
72588889|NCT00769067|144708750|SUPERIORITY_OR_OTHER|||||||0.011|TWO_SIDED|||||2-Sided.|Chi-squared|Unadjusted.||||||0.011
72588890|NCT00769067|144708753|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.822||||0.252|TWO_SIDED|95.0|0.587|1.151||2-Sided.|Log Rank|Adjusted by stratification factors: EGFR status, KRAS status and baseline ECOG performance status.|The estimated HR was for the Dacomitinib arm versus the Erlotinib arm.|HR and its 95% confidence interval were estimated from stratified Cox Regression and 2-sided p-value was based on the stratified log-rank test with EGFR status, KRAS status and baseline ECOG as stratification factors.||1.151|0.587|0.252
72588891|NCT03806933|144708754|OTHER||Hazard Ratio (HR)|1.03|||=|0.881|TWO_SIDED|95.0|0.7|1.51||P-values were based on Wald Chi-Square tests for hazard ratios.|Wald Chi-square test||Hazard ratio (HR) was estimated using a Cox proportional hazards regression model. 95% CIs were calculated based on individual Wald tests.|||1.51|0.7|= 0.881
72588892|NCT03806933|144708754|OTHER||Hazard Ratio (HR)|0.72|||=|0.089|TWO_SIDED|95.0|0.49|1.05||P-values were based on Wald Chi-Square tests for hazard ratios.|Wald Chi-square test||HR was estimated using a Cox proportional hazards regression model. 95% CIs were calculated based on individual Wald tests.|||1.05|0.49|= 0.089
72588893|NCT03806933|144708754|OTHER||Hazard Ratio (HR)|0.56||||0.0035|TWO_SIDED|95.0|0.38|0.83|||Wald Chi-square test|P-values were based on Wald Chi-Square tests for hazard ratios.|HR was estimated using a Cox proportional hazards regression model. 95% CIs were calculated based on individual Wald tests.|||0.83|0.38|0.0035
72588894|NCT03625466|144708766|SUPERIORITY||Mean Difference|-1.5|||||TWO_SIDED|95.0|-5.5|2.6||||||||2.6|-5.5|
72588895|NCT01058993|144708776|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||t-test, 2 sided|Student t-test-comparison means of normal subjects \& controls.||||||<0.05
72588896|NCT01058993|144708776|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Ratio paired t-test|Ratio paired t-test for comparison of baselines and responses for each category of leukocytes||The patients' leukocyte counts before and after plerixafor were compared.||||<0.05
72588897|NCT00394836|144708808|SUPERIORITY_OR_OTHER||percentage of responders|13.0|||||TWO_SIDED|95.0|4.0|31.0|||||Response rate is calculated as the number of responses divided by the number of participants treated \* 100.|||31|4|
72588898|NCT00394836|144708808|SUPERIORITY_OR_OTHER||percentage of responders|10.0|||||TWO_SIDED|95.0|5.0|19.0||||||||19|5|
72588899|NCT04932655|144708841|EQUIVALENCE|Two one-sided t test procedure used to compare test versus reference. Equivalence demonstrated if 90% CI within 80% to 125%.|Test/Reference Ratio of Geometric Means|103.22|||||TWO_SIDED|90.0|96.88|109.98||||||||109.98|96.88|
72588900|NCT04932655|144708841|EQUIVALENCE|Two one-sided t test procedure used to compare test versus reference. Equivalence demonstrated if 90% CI within 80% to 125%.|Test/Reference Ratio of Geometric Means|109.64|||||TWO_SIDED|90.0|102.9|116.82||||||||116.82|102.9|
72588901|NCT04932655|144708841|EQUIVALENCE|Two one-sided t test procedure used to compare test versus reference. Equivalence demonstrated if 90% CI within 80% to 125%.|Test/Reference Ratio of Geometric Means|102.9|||||TWO_SIDED|90.0|96.57|109.64||||||||109.64|96.57|
72588902|NCT04932655|144708842|EQUIVALENCE|Two one-sided t test procedure used to compare test versus reference. Equivalence demonstrated if 90% CI within 80% to 125%.|Test/Reference Ratio of Geometric Means|98.47|||||TWO_SIDED|90.0|96.33|100.65||||||||100.65|96.33|
72588903|NCT04932655|144708842|EQUIVALENCE|Two one-sided t test procedure used to compare test versus reference. Equivalence demonstrated if 90% CI within 80% to 125%.|Test/Reference Ratio of Geometric Means|98.88|||||TWO_SIDED|90.0|96.74|101.07||||||||101.07|96.74|
72588904|NCT04932655|144708842|EQUIVALENCE|Two one-sided t test procedure used to compare test versus reference. Equivalence demonstrated if 90% CI within 80% to 125%.|Test/Reference Ratio of Geometric Means|100.32|||||TWO_SIDED|90.0|98.15|102.54||||||||102.54|98.15|
72588905|NCT04932655|144708843|EQUIVALENCE|Two one-sided t test procedure used to compare test versus reference. Equivalence demonstrated if 90% CI within 80% to 125%.|Test/Reference Ratio of Geometric Means|98.5|||||TWO_SIDED|90.0|96.33|100.71||||||||100.71|96.33|
72588906|NCT04932655|144708843|EQUIVALENCE|Two one-sided t test procedure used to compare test versus reference. Equivalence demonstrated if 90% CI within 80% to 125%.|Test/Reference Ratio of Geometric Means|99.03|||||TWO_SIDED|90.0|96.85|101.26||||||||101.26|96.85|
72588907|NCT04932655|144708843|EQUIVALENCE|Two one-sided t test procedure used to compare test versus reference. Equivalence demonstrated if 90% CI within 80% to 125%.|Test/Reference Ratio of Geometric Means|100.25|||||TWO_SIDED|90.0|98.05|102.5||||||||102.50|98.05|
72588908|NCT01665157|144708844|SUPERIORITY_OR_OTHER|||||||0.435||||||Not significant|ANOVA|||||||0.435
72588909|NCT01665157|144708845|SUPERIORITY_OR_OTHER|||||||0.046|||||||Chi-squared|||||||0.046
72588910|NCT01665157|144708845|SUPERIORITY_OR_OTHER|||||||0.024|||||||Chi-squared|||"Null hypothesis: Low-residue diet package and 2L PEG vs. Self-controlled diet and 2L PEG provides same preparation quality."||||0.024
72588911|NCT01665157|144708845|SUPERIORITY_OR_OTHER|||||||0.041|||||||Chi-squared|||||||0.041
72588912|NCT01665157|144708848|SUPERIORITY_OR_OTHER||||||<|0.01||95.0|||||Chi-squared|||||||<0.01
72588913|NCT01665157|144708849|SUPERIORITY_OR_OTHER||||||<|0.01|||||||Chi-squared|||||||<0.01
72588914|NCT01665157|144708850|SUPERIORITY_OR_OTHER|||||||0.025|||||||Chi-squared|||||||0.025
72588915|NCT02780713|144708859|SUPERIORITY||Percentage|17.02|||||TWO_SIDED|95.0|11.79|24.58||||||||24.58|11.79|
72588916|NCT02780713|144708859|SUPERIORITY||Percentage|36.28|||||TWO_SIDED|95.0|23.84|55.2||||||||55.20|23.84|
72588917|NCT02780713|144708859|SUPERIORITY||Percentage|24.1|||||TWO_SIDED|95.0|16.84|34.48||||||||34.48|16.84|
72588918|NCT02780713|144708860|SUPERIORITY||Percentage|31.75|||||TWO_SIDED|95.0|25.77|39.12||||||||39.12|25.77|
72588919|NCT02780713|144708860|SUPERIORITY||Percentage|54.17|||||TWO_SIDED|95.0|42.16|69.6||||||||69.60|42.16|
72588920|NCT02780713|144708860|SUPERIORITY||Pecentage|41.23|||||TWO_SIDED|95.0|34.79|48.86||||||||48.86|34.79|
72588921|NCT02225860|144708872|SUPERIORITY_OR_OTHER||||||<|0.01|||||||t-test, 2 sided|||"The analysis of the primary and secondary outcome was based on an intention to treat principle. Copeptin was measured in each subject at baseline and week 2 and the change from baseline to end point (delta) was calculated for all subjects. The delta copeptin between subjects in the intervention and control arms was compared with a two sample t test for independent groups. One sample t-tests of the delta were used to examine whether there was any change over time for each group separately."||||<0.01
72588922|NCT02225860|144708873|SUPERIORITY_OR_OTHER||||||<|0.01|||||||t-test, 2 sided|||"The analysis of the primary and secondary outcome was based on an intention to treat principle. Copeptin was measured in each subject at baseline and week 2 and the change from baseline to end point (delta) was calculated for all subjects. The delta copeptin between subjects in the intervention and control arms was compared with a two sample t test for independent groups. One sample t-tests of the delta were used to examine whether there was any change over time for each group separately."||||<0.01
72588923|NCT05338502|144708875|SUPERIORITY||Geometric Least Squares Mean (LSM) Ratio|0.9|||||TWO_SIDED|90.0|0.797|1.02|||ANOVA|||Fasted State||1.02|0.797|
72588924|NCT05338502|144708875|SUPERIORITY||Geometric LS Mean Ratio|0.99|||||TWO_SIDED|90.0|0.876|1.12|||ANOVA|||Fed state||1.12|0.876|
72588925|NCT05338502|144708876|SUPERIORITY||Geometric LS Mean Ratio|0.932|||||TWO_SIDED|90.0|0.829|1.05|||ANOVA|||Fasted state||1.05|0.829|
72588926|NCT05338502|144708876|SUPERIORITY||Geometric LS Mean Ratio|1.0|||||TWO_SIDED|90.0|0.888|1.13|||ANOVA|||Fed State||1.13|0.888|
72588927|NCT05338502|144708878|SUPERIORITY||Geometric LS Mean Ratio|0.818|||||TWO_SIDED|90.0|0.68|0.985|||ANOVA|||Fasted State||0.985|0.680|
72588928|NCT05338502|144708878|SUPERIORITY||Geometric LS Mean Ratio|0.782|||||TWO_SIDED|90.0|0.645|0.949|||ANOVA|||Fed state||0.949|0.645|
72588929|NCT01250873|144708891|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Means|1.17|||||TWO_SIDED|90.0|1.06|1.3|||ANOVA|||||1.30|1.06|
72588930|NCT01250873|144708892|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Means|1.14|||||TWO_SIDED|90.0|1.01|1.28|||ANOVA|||||1.28|1.01|
72588931|NCT01250873|144708893|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.8281|TWO_SIDED|90.0|-0.5|1.0|||Wilcoxon (Mann-Whitney)|||||1.00|-0.50|0.8281
72588932|NCT01250873|144708894|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Means|1.27|||||TWO_SIDED|90.0|1.17|1.39|||ANOVA|||||1.39|1.17|
72414130|NCT05437510|144337242|SUPERIORITY||Efficacy|82.44|||<|0.0001|TWO_SIDED|95.0|67.271|91.357|||Exact method using binomial distribution|||"Statistical analysis for Overall:~The 2-sided 95% CI for the efficacy was calculated by an exact method assuming a binomial distribution of the number of RSV LRTI hospitalizations in the nirsevimab group conditional on the total number in both groups accounting for the follow-up time post-dosing/randomization."||91.357|67.271|<0.0001
72588933|NCT01250873|144708895|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Means|1.22|||||TWO_SIDED|90.0|1.1|1.36|||ANOVA|||||1.36|1.10|
72588934|NCT01250873|144708896|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|1.0||||0.3125|TWO_SIDED|90.0|0.0|2.0|||Wilcoxon (Mann-Whitney)|||||2.00|0.00|0.3125
72588935|NCT02278939|144708898|SUPERIORITY|||||||0.003||||||This was an intention to treat analysis using the Tukey-Kramer adjustment to account for unequal group sample sizes|ANOVA|||Hypothesis: the intervention group will have a significantly greater reduction in weight (kg) compared to the control from baseline to 3-months||||0.003
72588936|NCT02278939|144708899|SUPERIORITY|||||||0.001||||||This was an intention to treat analysis using the Tukey-Kramer adjustment to account for unequal group sample sizes|ANOVA|||Hypothesis: the intervention group will have a statistically greater reduction in percent weight compared to the control from baseline to 3-months||||.001
72588937|NCT02278939|144708900|SUPERIORITY|||||||0.002||||||This was an intention to treat analysis using the Tukey-Kramer adjustment to account for differences in group sample sizes|ANOVA|||Hypothesis: the intervention group will have a statistically greater reduction in BMI compared to the control from baseline to 3 months||||.002
72588938|NCT02111577|144708905|SUPERIORITY|Stratified by region (US vs other), prior abiraterone (Yes vs No), prior enzalutamide (Yes vs No) and Eastern Cooperative Oncology Group (ECOG) score (0, 1 vs 2)|Hazard Ratio (HR)|1.042||||0.596|TWO_SIDED|95.0|0.895|1.213|||Log Rank|||Stratified||1.213|0.895|0.596
72588939|NCT02111577|144708905|SUPERIORITY||Hazard Ratio (HR)|1.036||||0.648|TWO_SIDED|95.0|0.891|1.204|||Log Rank|||Unstratified||1.204|0.891|0.648
72588940|NCT02111577|144708906|SUPERIORITY|Stratified by region (US vs other), prior abiraterone (Yes vs No), prior enzalutamide (Yes vs No) and ECOG score (0, 1 vs 2)|Hazard Ratio (HR)|0.908||||0.335|TWO_SIDED|95.0|0.746|1.105|||Log Rank|||Stratified||1.105|0.746|0.335
72588941|NCT02111577|144708906|SUPERIORITY||Hazard Ratio (HR)|0.879||||0.192|TWO_SIDED|95.0|0.725|1.067|||Log Rank|||Unstratified||1.067|0.725|0.192
72588942|NCT02111577|144708907|SUPERIORITY|Stratified by region (US vs other), prior enzalutamide (Yes vs No) and ECOG score (0, 1 vs 2)|Hazard Ratio (HR)|1.312||||0.071|TWO_SIDED|95.0|0.976|1.762|||Log Rank|||Stratified||1.762|0.976|0.071
72588943|NCT02111577|144708907|SUPERIORITY||Hazard Ratio (HR)|1.283||||0.09|TWO_SIDED|95.0|0.961|1.712|||Log Rank|||Unstratified||1.712|0.961|0.09
72588944|NCT02111577|144708908|SUPERIORITY|Stratified by region (US vs other), prior abiraterone (Yes vs No) and ECOG score (0, 1 vs 2)|Hazard Ratio (HR)|1.461||||0.049|TWO_SIDED|95.0|1.0|2.134|||Log Rank|||Stratified||2.134|1|0.049
72588945|NCT02111577|144708908|SUPERIORITY||Hazard Ratio (HR)|1.436||||0.053|TWO_SIDED|95.0|0.993|2.077|||Log Rank|||Unstratified||2.077|0.993|0.053
72588946|NCT02111577|144708909|SUPERIORITY|Stratified by region (US vs other) and ECOG score (0, 1 vs 2)|Hazard Ratio (HR)|0.938||||0.501|TWO_SIDED|95.0|0.779|1.13|||Log Rank|||Stratified||1.13|0.779|0.501
72588947|NCT02111577|144708909|SUPERIORITY||Hazard Ratio (HR)|0.94||||0.512|TWO_SIDED|95.0|0.781|1.131|||Log Rank|||Unstratified||1.131|0.781|0.512
72588948|NCT02111577|144708910|SUPERIORITY|Stratified by region (US vs other), prior abiraterone (Yes vs No), prior enzalutamide (Yes vs No) and ECOG score (0, 1 vs 2)|Hazard Ratio (HR)|0.99||||0.886|TWO_SIDED|95.0|0.863|1.136|||Log Rank|||Stratified||1.136|0.863|0.886
72588949|NCT02111577|144708910|SUPERIORITY||Hazard Ratio (HR)|1.001||||0.992|TWO_SIDED|95.0|0.875|1.145|||Log Rank|||Unstratified||1.145|0.875|0.992
72588950|NCT02111577|144708911|SUPERIORITY|Stratified by region (US vs other), prior abiraterone (Yes vs No), prior enzalutamide (Yes vs No) and ECOG score (0, 1 vs 2)|Hazard Ratio (HR)|1.001||||0.994|TWO_SIDED|95.0|0.847|1.184|||Log Rank|||Stratified||1.184|0.847|0.994
72588951|NCT02111577|144708911|SUPERIORITY||Hazard Ratio (HR)|1.002||||0.982|TWO_SIDED|95.0|0.851|1.18|||Log Rank|||Unstratified||1.18|0.851|0.982
72588952|NCT02111577|144708912|SUPERIORITY|Stratified by region (US vs other), prior abiraterone (Yes vs No), prior enzalutamide (Yes vs No) and ECOG score (0, 1 vs 2)|Hazard Ratio (HR)|1.077||||0.392|TWO_SIDED|95.0|0.909|1.277|||Log Rank|||Stratified||1.277|0.909|0.392
72588953|NCT02111577|144708912|SUPERIORITY||Hazard Ratio (HR)|1.068||||0.439|TWO_SIDED|95.0|0.905|1.262|||Log Rank|||Unstratified||1.262|0.905|0.439
72588954|NCT02111577|144708913|SUPERIORITY|Stratified by region (US vs other), prior abiraterone (Yes vs No), prior enzalutamide (Yes vs No) and ECOG score (0, 1 vs 2)|Hazard Ratio (HR)|1.03||||0.754|TWO_SIDED|95.0|0.857|1.238|||Log Rank|||Stratified||1.238|0.857|0.754
72588955|NCT02111577|144708913|SUPERIORITY||Hazard Ratio (HR)|1.009||||0.924|TWO_SIDED|95.0|0.844|1.207|||Log Rank|||Unstratified||1.207|0.844|0.924
72588956|NCT02111577|144708914|SUPERIORITY|Stratified by region (US vs other), prior abiraterone (Yes vs No), prior enzalutamide (Yes vs No) and ECOG score (0, 1 vs 2)|Hazard Ratio (HR)|0.918||||0.732|TWO_SIDED|95.0|0.563|1.497|||Log Rank|||Stratified||1.497|0.563|0.732
72588957|NCT02111577|144708914|SUPERIORITY||Hazard Ratio (HR)|0.913||||0.713|TWO_SIDED|95.0|0.561|1.485|||Log Rank|||Unstratified||1.485|0.561|0.713
72588958|NCT02111577|144708915|SUPERIORITY|Stratified by region (US vs other), prior abiraterone (Yes vs No), prior enzalutamide (Yes vs No) and ECOG score (0, 1 vs 2)|Hazard Ratio (HR)|0.891||||0.694|TWO_SIDED|95.0|0.5|1.587|||Log Rank|||Stratified||1.587|0.5|0.694
72588959|NCT02111577|144708915|SUPERIORITY||Hazard Ratio (HR)|0.88||||0.661|TWO_SIDED|95.0|0.496|1.562|||Log Rank|||Unstratified||1.562|0.496|0.661
72588960|NCT02111577|144708916|SUPERIORITY|Stratified by region (US vs other), prior abiraterone (Yes vs No), prior enzalutamide (Yes vs No) and ECOG score (0, 1 vs 2)|Hazard Ratio (HR)|0.895||||0.111|TWO_SIDED|95.0|0.781|1.027|||Log Rank|||Stratified||1.027|0.781|0.111
72588961|NCT02111577|144708916|SUPERIORITY||Hazard Ratio (HR)|0.913||||0.184|TWO_SIDED|95.0|0.798|1.044|||Log Rank|||Unstratified||1.044|0.798|0.184
72588962|NCT02111577|144708917|SUPERIORITY|Stratified by region (US vs other), prior abiraterone (Yes vs No), prior enzalutamide (Yes vs No) and ECOG score (0, 1 vs 2)|Hazard Ratio (HR)|0.939||||0.46|TWO_SIDED|95.0|0.795|1.11|||Log Rank|||Stratified||1.11|0.795|0.46
72588963|NCT02111577|144708917|SUPERIORITY||Hazard Ratio (HR)|0.95||||0.534|TWO_SIDED|95.0|0.807|1.118|||Log Rank|||Unstratified||1.118|0.807|0.534
72588964|NCT02111577|144708918|SUPERIORITY|Adjusted by region (US vs other), prior abiraterone (Yes vs No), prior enzalutamide (Yes vs No) and ECOG score (0, 1 vs 2)|Risk Ratio (RR)|0.845||||0.485|TWO_SIDED|95.0|0.528|1.355|||Log binomial model|||Stratified||1.355|0.528|0.485
72588965|NCT02111577|144708919|SUPERIORITY|Adjusted by region (US vs other), prior abiraterone (Yes vs No), prior enzalutamide (Yes vs No) and ECOG score (0, 1 vs 2)|Risk Ratio (RR)|0.92||||0.768|TWO_SIDED|95.0|0.529|1.601|||Log binomial model|||Stratified||1.601|0.529|0.768
72588966|NCT03521115|144708940|SUPERIORITY||Odds Ratio (OR)|0.4|||<|0.01|TWO_SIDED||||||Regression, Logistic|b=-.91, controlling for condition (experimental vs. control) , IMR, baseline measure of outcome variable, teen gender, age, \& race.||6 month follow-up. Among those assigned to intervention, dosage was assigned as 0 for no exposure, 1 for completing only the communication, and 2 for completing the alcohol component. A probit analysis predicting completion was conducted from baseline measures and an instrumental variable, inverse Mills' ratio (IMR) representing the underlying selection processes was included as a covariate accounting for factors related to program completion. All controls were assigned 0 dosage.||||<0.01
72588967|NCT03521115|144708940|SUPERIORITY||Odds Ratio (OR)|0.58|||<|0.1|TWO_SIDED||||||Regression, Logistic||Controlling for condition (experimental vs. control) , IMR, baseline measure of outcome variable, teen gender, age, \& race.|12 month follow-up. Among those assigned to intervention, dosage was assigned as 0 for no exposure, 1 for completing only the communication, and 2 for completing the alcohol component. A probit analysis predicting completion was conducted from baseline measures and an instrumental variable, inverse Mills' ratio (IMR) representing the underlying selection processes was included as a covariate accounting for factors related to program completion. All controls were assigned 0 dosage.||||<0.10
72588968|NCT03521115|144708940|SUPERIORITY||Chi-Square|5.129||||0.077|TWO_SIDED||||||Chi-squared|||18 month follow-up. Among those assigned to intervention, dosage was assigned as 0 for no exposure, 1 for completing only the communication, and 2 for completing the alcohol component. All controls were assigned 0 dosage.||||.077
72588969|NCT03521115|144708941|SUPERIORITY||b|-0.47|||<|0.001|TWO_SIDED||||||Regression, Linear|Controled for condition (experimental vs. control) , IMR, baseline measure of outcome variable, teen gender, age, \& race.||6 month follow-up. Among those assigned to intervention, dosage was assigned as 0 for no exposure, 1 for completing only the communication, and 2 for completing the alcohol component. A probit analysis predicting completion was conducted from baseline measures and an instrumental variable, inverse Mills' ratio (IMR) representing the underlying selection processes was included as a covariate accounting for factors related to program completion. All controls were assigned 0 dosage.||||<0.001
72588970|NCT03521115|144708941|SUPERIORITY||b|-0.97|||<|0.01|TWO_SIDED||||||Regression, Linear|Controlled for condition (experimental vs. control) , IMR, baseline measure of outcome variable, teen gender, age, \& race.||12 month follow-up. Among those assigned to intervention, dosage was assigned as 0 for no exposure, 1 for completing only the communication, and 2 for completing the alcohol component. A probit analysis predicting completion was conducted from baseline measures and an instrumental variable, inverse Mills' ratio (IMR) representing the underlying selection processes was included as a covariate accounting for factors related to program completion. All controls were assigned 0 dosage.||||<0.01
72588971|NCT03521115|144708941|SUPERIORITY||F|0.85|||>|0.1|TWO_SIDED||||||ANOVA|||18 month follow-up. Among those assigned to intervention, dosage was assigned as 0 for no exposure, 1 for completing only the communication, and 2 for completing the alcohol component. All controls were assigned 0 dosage.||||>0.10
72588972|NCT03521115|144708942|SUPERIORITY||b|-0.22|||<|0.1|TWO_SIDED||||||Regression, Linear||controlling for condition (experimental vs. control) , IMR, baseline measure of outcome variable, teen gender, age, \& race.|6 month follow-up. Among those assigned to intervention, dosage was assigned as 0 for no exposure, 1 for completing only the communication, and 2 for completing the alcohol component. A probit analysis predicting completion was conducted from baseline measures and an instrumental variable, inverse Mills' ratio (IMR) representing the underlying selection processes was included as a covariate accounting for factors related to program completion. All controls were assigned 0 dosage.||||<0.10
72588973|NCT03521115|144708942|SUPERIORITY||b|-0.24|||<|0.05|TWO_SIDED||||||Regression, Linear||controlling for condition (experimental vs. control) , IMR, baseline measure of outcome variable, teen gender, age, \& race.|12 month follow-up. Among those assigned to intervention, dosage was assigned as 0 for no exposure, 1 for completing only the communication, and 2 for completing the alcohol component. A probit analysis predicting completion was conducted from baseline measures and an instrumental variable, inverse Mills' ratio (IMR) representing the underlying selection processes was included as a covariate accounting for factors related to program completion. All controls were assigned 0 dosage.||||<0.05
72588974|NCT03521115|144708942|SUPERIORITY||F|0.43|||>|0.1|TWO_SIDED||||||ANOVA|||18 month follow-up. Among those assigned to intervention, dosage was assigned as 0 for no exposure, 1 for completing only the communication, and 2 for completing the alcohol component. All controls were assigned 0 dosage.||||>0.10
72588975|NCT03521115|144708943|SUPERIORITY||b|-0.16|||<|0.1|TWO_SIDED||||||Regression, Linear|Controlled for condition (experimental vs. control) , IMR, baseline measure of outcome variable, teen gender, age, \& race.||6 month follow-up. Among those assigned to intervention, dosage was assigned as 0 for no exposure, 1 for completing only the communication, and 2 for completing the alcohol component. A probit analysis predicting completion was conducted from baseline measures and an instrumental variable, inverse Mills' ratio (IMR) representing the underlying selection processes was included as a covariate accounting for factors related to program completion. All controls were assigned 0 dosage.||||<.10
72588976|NCT03521115|144708943|SUPERIORITY||b|-0.26|||<|0.05|TWO_SIDED||||||Regression, Linear|Controlled for condition (experimental vs. control) , IMR, baseline measure of outcome variable, teen gender, age, \& race.||12 month follow-up. Among those assigned to intervention, dosage was assigned as 0 for no exposure, 1 for completing only the communication, and 2 for completing the alcohol component. A probit analysis predicting completion was conducted from baseline measures and an instrumental variable, inverse Mills' ratio (IMR) representing the underlying selection processes was included as a covariate accounting for factors related to program completion. All controls were assigned 0 dosage.||||<0.05
72588977|NCT03521115|144708943|SUPERIORITY||F|1.55|||>|0.1|TWO_SIDED||||||ANOVA|||18 month follow-up. Among those assigned to intervention, dosage was assigned as 0 for no exposure, 1 for completing only the communication, and 2 for completing the alcohol component. All controls were assigned 0 dosage.||||>0.10
72588978|NCT03521115|144708944|SUPERIORITY||b|-0.35|||<|0.05|TWO_SIDED||||||Regression, Linear||controlling for condition (experimental vs. control) , IMR, baseline measure of outcome variable, teen gender, age, \& race.|6 month follow-up. Among those assigned to intervention, dosage was assigned as 0 for no exposure, 1 for completing only the communication, and 2 for completing the alcohol component. A probit analysis predicting completion was conducted from baseline measures and an instrumental variable, inverse Mills' ratio (IMR) representing the underlying selection processes was included as a covariate accounting for factors related to program completion. All controls were assigned 0 dosage.||||<0.05
72588979|NCT03521115|144708944|SUPERIORITY||b|-0.02|||>|0.1|TWO_SIDED||||||Regression, Linear||controlling for condition (experimental vs. control) , IMR, baseline measure of outcome variable, teen gender, age, \& race.|12 month follow-up. Among those assigned to intervention, dosage was assigned as 0 for no exposure, 1 for completing only the communication, and 2 for completing the alcohol component. A probit analysis predicting completion was conducted from baseline measures and an instrumental variable, inverse Mills' ratio (IMR) representing the underlying selection processes was included as a covariate accounting for factors related to program completion. All controls were assigned 0 dosage.||||>0.10
72588980|NCT03521115|144708945|SUPERIORITY||b|0.299|||<|0.01|TWO_SIDED||||||generalized estimating equations||controlling for condition (experimental vs. control) , IMR, baseline measure of outcome variable, teen gender, age, \& race.|Among those assigned to intervention, dosage was assigned as 0 for no exposure, 1 for completing some of the program, and 2 for completing the relationship component. A probit analysis predicting completion was conducted from baseline measures and an instrumental variable, inverse Mills' ratio (IMR) representing the underlying selection processes was included as a covariate accounting for factors related to program completion. All controls were assigned 0 dosage.||||<0.01
72588981|NCT03521115|144708946|SUPERIORITY||b|0.268|||<|0.03|TWO_SIDED||||||generalized estimating equations|||Among those assigned to intervention, dosage was assigned as 0 for no exposure, 1 for completing some of the program, and 2 for completing the relationship component. A probit analysis predicting completion was conducted from baseline measures and an instrumental variable, inverse Mills' ratio (IMR) representing the underlying selection processes was included as a covariate accounting for factors related to program completion. All controls were assigned 0 dosage.||||<.03
72588982|NCT03521115|144708947|SUPERIORITY||b|0.075|||>|0.1|TWO_SIDED||||||generalized estimating equations||controlling for condition (experimental vs. control) , IMR, baseline measure of outcome variable, teen gender, age, \& race.|Among those assigned to intervention, dosage was assigned as 0 for no exposure, 1 for completing some of the program, and 2 for completing the relationship component. A probit analysis predicting completion was conducted from baseline measures and an instrumental variable, inverse Mills' ratio (IMR) representing the underlying selection processes was included as a covariate accounting for factors related to program completion. All controls were assigned 0 dosage.||||>0.10
72588983|NCT03521115|144708948|SUPERIORITY||b|0.051|||>|0.1|TWO_SIDED||||||generalized estimating equations||controlling for condition (experimental vs. control) , IMR, baseline measure of outcome variable, teen gender, age, \& race.|Among those assigned to intervention, dosage was assigned as 0 for no exposure, 1 for completing some of the program, and 2 for completing the relationship component. A probit analysis predicting completion was conducted from baseline measures and an instrumental variable, inverse Mills' ratio (IMR) representing the underlying selection processes was included as a covariate accounting for factors related to program completion. All controls were assigned 0 dosage.||||>0.10
72588984|NCT03521115|144708949|SUPERIORITY||b|0.72|||<|0.05|TWO_SIDED||||||generalized estimating equations|||Among those assigned to intervention, dosage was assigned as 0 for no exposure, 1 for completing some of the program, and 2 for completing the relationship component. A probit analysis predicting completion was conducted from baseline measures and an instrumental variable, inverse Mills' ratio (IMR) representing the underlying selection processes was included as a covariate accounting for factors related to program completion. All controls were assigned 0 dosage.||||<0.05
72588985|NCT03521115|144708950|SUPERIORITY||||||>|0.1|||||||Chi-squared|||Among those assigned to intervention, dosage was assigned as 0 for no exposure, 1 for completing some of the program, and 2 for completing the relationship component. A probit analysis predicting completion was conducted from baseline measures and an instrumental variable, inverse Mills' ratio (IMR) representing the underlying selection processes was included as a covariate accounting for factors related to program completion. All controls were assigned 0 dosage.||||>0.10
72588986|NCT04501640|144708969|OTHER||Geomteric Least Squares (LS) Mean Ratio|57.06|||||TWO_SIDED|90.0|46.21|70.47|||||Ratios and confidence intervals are transformed back to raw scale \& values are expressed as percentages.|Assessment based on an analysis of variance (ANOVA) performed on natural log-transformed parameters with food condition and period as a fixed effects and participant as a random effect.||70.47|46.21|
72588987|NCT04501640|144708969|OTHER||Geometric LSMean Ratio|61.42|||||TWO_SIDED|90.0|52.06|72.47|||||Ratios and confidence intervals are transformed back to raw scale \& values are expressed as percentages.|Assessment based on an ANOVA performed on natural log-transformed parameters with food condition and period as a fixed effects and participant as a random effect.||72.47|52.06|
72588988|NCT04501640|144708970|OTHER||Geomteric LSMean Ratio|53.31|||||TWO_SIDED|90.0|43.02|66.05|||||Ratios and confidence intervals are transformed back to raw scale \& values are expressed as percentages.|Assessment based on an ANOVA performed on natural log-transformed parameters with food condition and period as a fixed effects and participant as a random effect.||66.05|43.02|
72588989|NCT04501640|144708970|OTHER||Geomteric LSMean Ratio|59.14|||||TWO_SIDED|90.0|49.48|70.7|||||Ratios and confidence intervals are transformed back to raw scale \& values are expressed as percentages.|Assessment based on an ANOVA performed on natural log-transformed parameters with food condition and period as a fixed effects and participant as a random effect.||70.70|49.48|
72588990|NCT04501640|144708971|OTHER||Geometric LSMean Ratio|38.93|||||TWO_SIDED|90.0|26.78|56.59|||||Ratios and confidence intervals are transformed back to raw scale \& values are expressed as percentages.|Assessment based on an ANOVA performed on natural log-transformed parameters with food condition and period as a fixed effects and participant as a random effect.||56.59|26.78|
72588991|NCT04501640|144708971|OTHER||Geometric LSMean Ratio|47.9|||||TWO_SIDED|90.0|31.76|72.24|||||Ratios and confidence intervals are transformed back to raw scale \& values are expressed as percentages.|Assessment based on an ANOVA performed on natural log-transformed parameters with food condition and period as a fixed effects and participant as a random effect.||72.24|31.76|
72588992|NCT01981954|144708973|OTHER||||||<|0.001||||||From a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.|t-test, 2 sided|||Week 24 MCC Analysis||||<0.001
72588993|NCT01981954|144708975|OTHER|||||||0.003||||||From a 2-sided one sample t-test, testing the null hypothesis that change from baseline=0.|t-test, 2 sided|||Week 24 Analysis||||0.003
72588994|NCT01981954|144708976|OTHER|||||||0.744||||||From a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.|t-test, 2 sided|||Week 24 Analysis||||0.744
72588995|NCT01981954|144708977|OTHER|||||||0.352||||||From a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.|t-test, 2 sided|||Week 24 Analysis||||0.352
72588996|NCT01981954|144708978|OTHER||||||<|0.001||||||From a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.|t-test, 2 sided|||Week 24 Analysis||||<0.001
72588997|NCT01981954|144708979|OTHER|||||||0.177||||||From a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.|t-test, 2 sided|||Week 24 Analysis||||0.177
72588998|NCT01981954|144708980|OTHER|||||||0.025||||||From a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.|t-test, 2 sided|||Week 24 Analyis||||0.025
72588999|NCT01981954|144708981|OTHER|||||||0.05||||||From a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.|t-test, 2 sided|||Week 24 Analysis||||0.050
72589000|NCT01981954|144708982|OTHER|||||||0.567||||||From a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.|t-test, 2 sided|||Week 24 Analysis||||0.567
72589001|NCT01981954|144708983|OTHER|||||||0.001||||||From a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.|t-test, 2 sided|||Week 24 Analysis||||0.001
72589002|NCT01981954|144708984|OTHER||||||<|0.001||||||From a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.|t-test, 2 sided|||Week 24 Analysis||||<0.001
72589003|NCT01981954|144708985|OTHER|||||||0.004||||||From a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.|t-test, 2 sided|||Week 24 Analysis||||0.004
72589004|NCT01981954|144708986|OTHER|||||||0.001||||||From a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.|t-test, 2 sided|||Week 24 Analysis||||0.001
72589005|NCT01981954|144708987|OTHER|||||||0.001||||||From a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.|t-test, 2 sided|||Week 24 Analysis||||0.001
72589006|NCT01981954|144709004|OTHER|||||||0.688||||||From a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.|t-test, 2 sided|||Week 24 Analysis||||0.688
72589007|NCT01981954|144709005|OTHER|||||||0.61||||||From a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.|t-test, 2 sided|||Week 24 Analysis||||0.610
72589008|NCT01981954|144709006|OTHER|||||||0.562||||||From a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.|t-test, 2 sided|||Week 24 Analysis||||0.562
72589009|NCT01981954|144709007|OTHER|||||||0.657||||||From a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.|t-test, 2 sided|||Week 24 Analysis||||0.657
72589010|NCT01981954|144709008|OTHER|||||||0.631||||||From a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.|t-test, 2 sided|||Week 24 Analysis||||0.631
72589011|NCT01981954|144709009|OTHER|||||||0.41||||||From a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.|t-test, 2 sided|||Week 24 Analysis||||0.410
72589012|NCT01981954|144709010|OTHER|||||||0.94||||||From a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.|t-test, 2 sided|||Week 24 Analysis||||0.940
72589013|NCT01981954|144709011|OTHER|||||||1||||||From a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.|t-test, 2 sided|||Week 24 Analysis||||1.000
72589014|NCT01981954|144709012|OTHER|||||||0.575||||||From a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0|t-test, 2 sided|||Week 24 Analysis||||0.575
72589015|NCT01981954|144709013|OTHER|||||||0.031||||||From a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.|t-test, 2 sided|||Week 24 Analysis||||0.031
72589016|NCT01981954|144709014|OTHER|||||||0.721||||||From a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.|t-test, 2 sided|||Week 24 Analysis||||0.721
72589017|NCT03655470|144709015|SUPERIORITY||Mean Difference (Final Values)|0.59|STANDARD_ERROR_OF_MEAN|0.07||0.3|TWO_SIDED||||||Mixed Models Analysis|||||||.30
72589018|NCT03063086|144709023|SUPERIORITY||Mean Difference (Final Values)|0.172|||<|0.0001|TWO_SIDED|95.0|0.137|0.208|||Mixed Models Analysis|||||0.208|0.137|<0.0001
72589019|NCT03063086|144709023|SUPERIORITY||Median Difference (Final Values)|0.159|||<|0.0001|TWO_SIDED|95.0|0.123|0.195|||Mixed Models Analysis|||||0.195|0.123|<0.0001
72589020|NCT03063086|144709028|SUPERIORITY||Mean Difference (Final Values)|0.124|||<|0.0001|TWO_SIDED|95.0|0.086|0.161|||Mixed Models Analysis|||||0.161|0.086|<0.0001
72589021|NCT04590586|144709034|SUPERIORITY||Hazard Ratio (HR)|1.17||||0.6672|TWO_SIDED|95.0|0.59|2.35|||Stratified log-rank test|Stratified by baseline score of 2 on the ordinal scale for clinical severity (yes/no), remdesivir use at baseline (yes/no), and geographic region.|Hazard ratio (Lanadelumab vs. placebo) from a Cox regression model including baseline clinical severity of 2 on the ordinal scale for clinical severity (yes/no), remdesivir use at baseline (yes/no), geographic region, and treatment arm as factors.|||2.35|0.59|0.6672
72589022|NCT04590586|144709035|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.8779|TWO_SIDED|95.0|0.77|1.24|||Stratified log-rank test|Stratified by baseline score of 2 on the ordinal scale for clinical severity (yes/no), remdesivir use at baseline (yes/no), and geographic region.|Hazard ratio (apremilast vs. placebo) from a Cox regression model including baseline clinical severity of 2 on the ordinal scale for clinical severity (yes/no), remdesivir use at baseline (yes/no), geographic region, and treatment arm as factors.|||1.24|0.77|0.8779
72589023|NCT04590586|144709047|OTHER||Risk Difference (RD)|-4.0||||0.3773|TWO_SIDED|95.0|-12.9|4.9|||Regression, Logistic||Risk difference is from a logistic regression including the baseline clinical severity of 2 on the ordinal scale for clinical severity (yes/no), remdesivir use at baseline (yes/no), geographic region, and treatment arm as factors.|||4.9|-12.9|0.3773
72589024|NCT04590586|144709047|OTHER||Odds Ratio (OR)|0.82|||||TWO_SIDED|95.0|0.52|1.28|||||Odds ratio (apremilast vs. placebo) is from a logistic regression including the baseline clinical severity of 2 on the ordinal scale for clinical severity (yes/no), remdesivir use at baseline (yes/no), geographic region, and treatment arm as factors.|||1.28|0.52|
72589025|NCT04590586|144709048|OTHER||Risk Difference (RD)|-2.9||||0.4846|TWO_SIDED|95.0|-11.2|5.3|||Regression, Logistic||Risk difference is from a logistic regression including baseline clinical severity of 2 on the ordinal scale for clinical severity (yes/no), remdesivir use at baseline (yes/no), geographic region, and treatment arm as factors.|||5.3|-11.2|0.4846
72589026|NCT04590586|144709048|OTHER||Odds Ratio (OR)|0.84|||||TWO_SIDED|95.0|0.51|1.37|||||Odds ratio (apremilast vs. placebo) is from a logistic regression including baseline clinical severity of 2 on the ordinal scale for clinical severity (yes/no), remdesivir use at baseline (yes/no), geographic region, and treatment arm as factors.|||1.37|0.51|
72589027|NCT04590586|144709049|OTHER||Risk Difference (RD)|0.2||||0.9665|TWO_SIDED|95.0|-7.3|7.6|||Regression, Logistic||Risk difference is from a logistic regression including baseline clinical severity of 2 on the ordinal scale for clinical severity (yes/no), remdesivir use at baseline (yes/no), geographic region, and treatment arm as factors.|||7.6|-7.3|0.9665
72589028|NCT04590586|144709049|OTHER||Odds Ratio (OR)|1.01|||||TWO_SIDED|95.0|0.59|1.74|||||Odds ratio (apremilast vs. placebo) is from a logistic regression including the baseline clinical severity of 2 on the ordinal scale for clinical severity (yes/no), remdesivir use at baseline (yes/no), geographic region, and treatment arm as factors.|||1.74|0.59|
72589029|NCT04590586|144709050|OTHER||Odds Ratio (OR)|1.02||||0.9119|TWO_SIDED|95.0|0.71|1.46|||Proportional odds model||Odds ratio (Apremilast vs. Placebo) from a proportional odds model including the baseline clinical severity of 2 on the 8-point ordinal scale for clinical severity (yes/no), remdesivir use at baseline (yes/no), region, and treatment arm as factors.|Day 8||1.46|0.71|0.9119
72589030|NCT04590586|144709050|OTHER||Odds Ratio (OR)|1.09||||0.6475|TWO_SIDED|95.0|0.75|1.58|||Proportional odds model||Odds ratio (Apremilast vs. Placebo) from a proportional odds model including the baseline clinical severity of 2 on the 8-point ordinal scale for clinical severity (yes/no), remdesivir use at baseline (yes/no), region, and treatment arm as factors.|Day 15||1.58|0.75|0.6475
72589031|NCT04590586|144709050|OTHER||Odds Ratio (OR)|0.98||||0.9071|TWO_SIDED|95.0|0.64|1.48|||Proportional odds model||Odds ratio (Apremilast vs. Placebo) from a proportional odds model including the baseline clinical severity of 2 on the 8-point ordinal scale for clinical severity (yes/no), remdesivir use at baseline (yes/no), region, and treatment arm as factors.|Day 29||1.48|0.64|0.9071
72589032|NCT04590586|144709051|OTHER||Odds Ratio (OR)|1.15||||0.4507|TWO_SIDED|95.0|0.8|1.66|||Proportional odds model||Odds ratio (Apremilast vs. Placebo) from a proportional odds model including the baseline clinical severity of 2 on the 8-point ordinal scale for clinical severity (yes/no), remdesivir use at baseline (yes/no), region, and treatment arm as factors.|||1.66|0.80|0.4507
72589033|NCT04590586|144709052|OTHER||Odds Ratio (OR)|0.99||||0.9741|TWO_SIDED|95.0|0.64|1.53|||Proportional odds model||Odds ratio (Apremilast vs. Placebo) from a proportional odds model including the baseline clinical severity of 2 on the 8-point ordinal scale for clinical severity (yes/no), remdesivir use at baseline (yes/no), region, and treatment arm as factors.|||1.53|0.64|0.9741
72589034|NCT04590586|144709053|OTHER||Odds Ratio (OR)|1.04||||0.8754|TWO_SIDED|95.0|0.64|1.7|||Proportional odds model||Odds ratio (Apremilast vs. Placebo) from a proportional odds model including the baseline clinical severity of 2 on the 8-point ordinal scale for clinical severity (yes/no), remdesivir use at baseline (yes/no), region, and treatment arm as factors.|||1.70|0.64|0.8754
72589035|NCT04590586|144709054|OTHER||Risk Difference (RD)|0.2||||0.9695|TWO_SIDED|95.0|-8.7|9.1|||Regression, Logistic||Risk difference is from a logistic regression including the baseline clinical severity of 2 on the ordinal scale for clinical severity (yes/no), remdesivir use at baseline (yes/no), geographic region, and treatment arm as factors.|Analysis of clinical recovery on Day 8||9.1|-8.7|0.9695
72589036|NCT04590586|144709054|OTHER||Odds Ratio (OR)|1.01|||||TWO_SIDED|95.0|0.64|1.59|||||Odds ratio (apremilast vs. placebo) is from a logistic regression including the baseline clinical severity of 2 on the ordinal scale for clinical severity (yes/no), remdesivir use at baseline (yes/no), geographic region, and treatment arm as factors.|Analysis of clinical recovery on Day 8||1.59|0.64|
72589037|NCT04590586|144709054|OTHER||Risk Difference (RD)|-2.4||||0.6236|TWO_SIDED|95.0|-11.9|7.1|||Regression, Logistic||Risk difference is from a logistic regression including the baseline clinical severity of 2 on the ordinal scale for clinical severity (yes/no), remdesivir use at baseline (yes/no), geographic region, and treatment arm as factors.|Analysis of clinical recovery on Day 15||7.1|-11.9|0.6236
72589038|NCT04590586|144709054|OTHER||Odds Ratio (OR)|0.9|||||TWO_SIDED|95.0|0.59|1.37|||||Odds ratio (apremilast vs. placebo) is from a logistic regression including the baseline clinical severity of 2 on the ordinal scale for clinical severity (yes/no), remdesivir use at baseline (yes/no), geographic region, and treatment arm as factors.|Analysis of clinical recovery on Day 15||1.37|0.59|
72589039|NCT04590586|144709054|OTHER||Risk Difference (RD)|-6.2||||0.1664|TWO_SIDED|95.0|-14.9|2.5|||Regression, Logistic||Risk difference is from a logistic regression including the baseline clinical severity of 2 on the ordinal scale for clinical severity (yes/no), remdesivir use at baseline (yes/no), geographic region, and treatment arm as factors.|Analysis of clinical recovery on Day 29||2.5|-14.9|0.1664
72589040|NCT04590586|144709054|OTHER||Odds Ratio (OR)|0.72|||||TWO_SIDED|95.0|0.45|1.15|||||Odds ratio (apremilast vs. placebo) is from a logistic regression including the baseline clinical severity of 2 on the ordinal scale for clinical severity (yes/no), remdesivir use at baseline (yes/no), geographic region, and treatment arm as factors.|Analysis of clinical recovery on Day 29||1.15|0.45|
72589041|NCT04590586|144709055|OTHER||Risk Difference (RD)|-0.5||||0.9043|TWO_SIDED|95.0|-9.3|8.3|||Regression, Logistic||Risk difference is from a logistic regression including the baseline clinical severity of 2 on the ordinal scale for clinical severity (yes/no), remdesivir use at baseline (yes/no), geographic region, and treatment arm as factors.|||8.3|-9.3|0.9043
72589042|NCT04590586|144709055|OTHER||Odds Ratio (OR)|0.97|||||TWO_SIDED|95.0|0.62|1.54|||||Odds ratio (apremilast vs. placebo) is from a logistic regression including the baseline clinical severity of 2 on the ordinal scale for clinical severity (yes/no), remdesivir use at baseline (yes/no), geographic region, and treatment arm as factors.|||1.54|0.62|
72589043|NCT01893281|144709068|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<0.001
72589044|NCT02218736|144709071|SUPERIORITY|||||||0.0095|||||||t-test, 1 sided|||||||0.0095
72589045|NCT02218736|144709072|SUPERIORITY|||||||0.0345|||||||t-test, 1 sided|||||||0.0345
72589046|NCT02218736|144709073|SUPERIORITY|||||||0.43|||||||t-test, 1 sided|||||||0.430
72589047|NCT05481125|144709086|NON_INFERIORITY|Non-inferiority margin = 0.1 logMAR|Mean Difference (Final Values)|-0.045|STANDARD_ERROR_OF_MEAN|0.0125|||ONE_SIDED|95.0||-0.024||Since a non-inferiority hypothesis is being tested, a p-value is not applicable. Confidence limit is being reported and compared to the non-inferiority margin.|||Mean difference (Clareon/Clareon Toric minus Eyhance/Eyhance Toric). Upper Confidence Limit is presented.|||-0.024||
72589048|NCT01598090|144709103|NON_INFERIORITY|Non-inferiority of Lambda/RBV/TVR to Alfa/RBV/TVR was not established because the lower limit of the 95% CI was less than the predefined non-inferiority margin of -12%. As a result, key secondary endpoints were not tested hierarchically to compare treatment groups.||||||0.0855||||||Non-inferiority testing is based on lower limit of confidence interval.|Mantel Haenszel|||||||0.0855
72589049|NCT00422695|144709115|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Chi-squared|||||||<0.05
72589050|NCT00422695|144709115|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
72414131|NCT05437510|144337242|SUPERIORITY||Efficacy|86.11|||<|0.0001|TWO_SIDED|95.0|60.283|96.459|||Exact method using binomial distribution|||"Statistical analysis for France:~The 2-sided 95% CI for the efficacy was calculated by an exact method assuming a binomial distribution of the number of RSV LRTI hospitalizations in the nirsevimab group conditional on the total number in both groups accounting for the follow-up time post-dosing/randomization."||96.459|60.283|<0.0001
72589051|NCT00355147|144709173|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.05|STANDARD_ERROR_OF_MEAN|0.11||0.69|TWO_SIDED||||||Mixed Models Analysis|Adjusted for site, strata, baseline score, randomized group, month and the group by month interaction|This score represents change from baseline to six months across the groups.|This is an analysis of the outcome, Stroke Specific Quality of Life Overall Total Score.||||0.69
72589052|NCT00355147|144709173|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.47|STANDARD_ERROR_OF_MEAN|0.23||0.05|TWO_SIDED|||||Adjusted for site, strata, baseline value, treatment group, month of assessment, treatment group x month, random subject effect|Mixed Models Analysis||This score represents change from baseline to three months across groups.|This is an analysis of the Perceived Energy Domain within the Stroke Specific Quality of Life Measure||||0.05
72589053|NCT00355147|144709174|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.12||||0.66|TWO_SIDED||||||Mixed Models Analysis|Adjusted by site, strata, baseline score, treatment group, month and group by month interaction|The score is the change from baseline to six months between groups.|||||0.66
72589054|NCT00355147|144709175|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.74||||0.06|TWO_SIDED|95.0|0.88|51.31|||Regression, Logistic|||||51.31|0.88|0.06
72589055|NCT00355147|144709175|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.45||||0.036|TWO_SIDED|95.0|1.08|10.96|||Regression, Logistic|||Within group Intervention Pre Post Comparison Compliance with Diabetes Medication||10.96|1.08|0.036
72589056|NCT00355147|144709175|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.51||||0.407|TWO_SIDED|95.0|0.1|2.7|||Regression, Logistic|||Within Group attention control group intervention pre post comparison compliance with Diabetes Medication||2.70|0.10|0.407
72589057|NCT00355147|144709176|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.56||||0.05|TWO_SIDED|95.0|0.54|4.48|||Regression, Logistic|||Between Group Intervention Pre Post Comparison Compliance with Statin Medication||4.48|0.54|0.05
72589058|NCT00355147|144709176|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.98||||0.0001|TWO_SIDED|95.0|2.81|12.76|||Regression, Logistic|||Within Group Intervention Pre Post Comparison Compliance with Statin Medication||12.76|2.81|0.0001
72589059|NCT00355147|144709176|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.83||||0.0004|TWO_SIDED|95.0|1.83|8.01|||Regression, Logistic|||Within Group Attention Control Pre Post Comparison Compliance with Statin Medication.||8.01|1.83|0.0004
72589060|NCT00355147|144709177|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.34||||0.096|TWO_SIDED|95.0|0.86|6.4|||Regression, Logistic|||Between Group Intervention Pre Post Comparison Compliance with Hypertension Medication||6.40|0.86|0.096
72589061|NCT00355147|144709177|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.68||||0.0004|TWO_SIDED|95.0|1.81|7.48|||Regression, Logistic|||Within Group Intervention Pre Post Comparison Compliance with Hypertension Medication||7.48|1.81|0.0004
72589062|NCT00355147|144709177|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.57||||0.21|TWO_SIDED|95.0|0.77|3.21|||Regression, Logistic|||Within Group Attention Group Pre Post Comparison Compliance with Hypertension Medication.||3.21|0.77|0.21
72589063|NCT02060058|144709181|OTHER|The evaluation of SVR rate was based on full-analysis-set (FAS) and modified intention-to-treat population (mITT). FAS population included subjects receiving ≥ 1 dose of any antiviral agents (boceprevir and/or PEG-IFN, and/or RBV). MITT population included subjects receiving ≥ 1 dose of boceprevir.||||||0.01|||||||Chi-squared|||||||0.01
72589064|NCT01672710|144709184|SUPERIORITY||Mean Difference (Net)|6.9|||<|0.05|TWO_SIDED|95.0|-0.3|14.2|||ANCOVA|||||14.2|-0.3|<0.05
72589065|NCT01399047|144709195|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.105||||0.21|TWO_SIDED|95.0|-0.033|0.243|||Prescott's test||Mycophenolate was tolerated in 17/19 subjects (89.5%, 95% CI: 66.9% - 98.7%), while placebo was tolerated in 19/19 subjects (100%, 95% CI: 82.4% - 100%). The difference in tolerability rates was 10.5% (95% CI: -3.3% - 24.3%, p=0.21).|The primary outcome variable was tolerability, defined as the proportion of subjects able to complete 8 weeks on the assigned treatment. Tolerability was compared among the treatment groups using Prescott's test. A 95% confidence interval was computed for the tolerability of mycophenolate, placebo, and their difference.||0.243|-0.033|0.21
72589066|NCT01399047|144709196|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.69||||0.72|TWO_SIDED|95.0|-4.67|3.28|||Prescott's test|||||3.28|-4.67|0.72
72589067|NCT01399047|144709197|SUPERIORITY|||||||0.78|||||||Prescott's test|||||||0.78
72589068|NCT01399047|144709198|SUPERIORITY|||||||0.98|||||||Prescott's test|||||||0.98
72589069|NCT01399047|144709199|SUPERIORITY|||||||0.26|||||||Wilcoxon (Mann-Whitney)|||||||0.26
72589070|NCT02046005|144709200|SUPERIORITY||Risk Ratio (RR)|1.23||||0.043|TWO_SIDED|95.0|1.01|1.51||We compared the PRE-RA group (PRE-RA arm and PRE-RA Plus arm combined) to the Comparison arm for the primary composite outcome at the 3 primary post-intervention time points using generalized estimating equations (GEE).|generalized estimating equations||PRE-RA group (combined PRE-RA arm and PRE-RA Plus arm) compared to Comparison arm (reference)|"In the primary analysis, we combined the PRE-RA and PRE-RA Plus arms into a single PRE-RA group and compared it to the Comparison arm (aka General Rheumatoid Arthritis Education)"||1.51|1.01|0.043
72589071|NCT00251303|144709201|SUPERIORITY_OR_OTHER|||||||0.959||95.0|||||Chi-squared|||||||0.959
72589072|NCT00504725|144709203|SUPERIORITY_OR_OTHER|||||||0.39||95.0||||We will use two way ANOVA (looking for effects due to drug and time) with a p value of 0.05 indicative of statistical significance.|ANOVA|||IL-6||||0.39
72589073|NCT00504725|144709203|SUPERIORITY_OR_OTHER|||||||0.18||95.0|||||ANOVA|||IL-8||||0.18
72589074|NCT00504725|144709203|SUPERIORITY_OR_OTHER|||||||0.14||95.0|||||ANOVA|||IL-10||||0.14
72589075|NCT00504725|144709204|SUPERIORITY_OR_OTHER|||||||0.37||95.0|||||ANOVA|||||||0.37
72589076|NCT00504725|144709205|SUPERIORITY_OR_OTHER|||||||0.44||95.0||||Baseline Pain Level Score|Fisher Exact|||||||0.44
72589077|NCT00504725|144709205|SUPERIORITY_OR_OTHER|||||||0.2||95.0||||4 Hour Pain Level Score|Fisher Exact|||||||0.20
72589078|NCT00504725|144709205|SUPERIORITY_OR_OTHER|||||||0.37||95.0||||24 Hour Pain Level Score|Fisher Exact|||||||0.37
72589079|NCT00504725|144709205|SUPERIORITY_OR_OTHER|||||||0.15||95.0||||Pain Level Score at Discharge|Fisher Exact|||||||0.15
72589080|NCT03214380|144709232|NON_INFERIORITY|Non-inferiority Margin = 0.4 for HbA1c|Least Square Mean Difference (LSMean)|0.06|||||TWO_SIDED|95.0|-0.05|0.16||||||||0.16|-0.05|
72589081|NCT03214380|144709233|SUPERIORITY||Mean Difference (Net)|-11.8|||<|0.001|TWO_SIDED|95.0|-18.1|-5.5|||ANCOVA|||||-5.5|-18.1|<0.001
72589082|NCT03214380|144709234|SUPERIORITY||Mean Difference (Net)|-17.4|||<|0.001|TWO_SIDED|95.0|-25.3|-9.5|||ANCOVA|||||-9.5|-25.3|<0.001
72589083|NCT02028767|144709280|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence test|Geometric mean ratio|98.57|STANDARD_ERROR_OF_MEAN|1.024||0|TWO_SIDED|90.0|94.662|102.639||The p-value relates to the null hypothesis of non-equivalence.|ANOVA||"The geometric mean ratio is the exponential of the estimated mean difference on the log-scale between 'FDC' and 'Separate tablets'.~ANOVA on the log scale: sequence, period and treatment as fixed effects; subjects within sequences as random effect"|||102.639|94.662|0.0000
72589084|NCT02028767|144709280|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence test|Geometric mean ratio|98.71|STANDARD_ERROR_OF_MEAN|1.024|<|0.0001|TWO_SIDED|90.0|94.783|102.796||The p-value relates to the null hypothesis of non-equivalence.|ANOVA||"The geometric mean ratio is the exponential of the estimated mean difference on the log-scale between 'FDC' and 'Separate tablets'.~ANOVA on the log-scale: sequence, subjects within sequences, period and treatment as fixed effects"|Analysis with fixed effects for all terms||102.796|94.783|<0.0001
72589085|NCT02028767|144709281|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence test|Geometric mean ratio|98.93|STANDARD_ERROR_OF_MEAN|1.019||0|TWO_SIDED|90.0|95.856|102.107||The p-value relates to the null hypothesis of non-equivalence.|ANOVA||"The geometric mean ratio is the exponential of the estimated mean difference on the log-scale between 'FDC' and 'Separate tablets'.~ANOVA on the log-scale: sequence, period and treatment as fixed effects; subjects within sequences as random effect"|||102.107|95.856|0.0000
72589086|NCT02028767|144709281|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence test|Geometric mean ratio|98.96|STANDARD_ERROR_OF_MEAN|1.019|<|0.0001|TWO_SIDED|90.0|95.877|102.15||The p-value relates to the null hypothesis of non-equivalence.|ANOVA||"The geometric mean ratio is the exponential of the estimated mean difference on the log-scale between 'FDC' and 'Separate tablets'.~ANOVA on the log-scale: sequence, subjects within sequences, period and treatment as fixed effects"|Analysis with fixed effects for all terms||102.150|95.877|<0.0001
72589087|NCT02028767|144709282|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence test|Geometric mean ratio|98.28|STANDARD_ERROR_OF_MEAN|1.023||0|TWO_SIDED|90.0|94.549|102.156||The p-value relates to the null hypothesis of non-equivalence.|ANOVA||"The geometric mean ratio is the exponential of the estimated mean difference on the log-scale between 'FDC' and 'Separate tablets'.~ANOVA on the log-scale: sequence, period and treatment as fixed effects; subjects within sequences as random effect"|||102.156|94.549|0.0000
72589088|NCT02028767|144709282|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence test|Geometric mean ratio|98.35|STANDARD_ERROR_OF_MEAN|1.023|<|0.0001|TWO_SIDED|90.0|94.603|102.252|||ANOVA|The p-value relates to the null hypothesis of non-equivalence.|"The geometric mean ratio is the exponential of the estimated mean difference on the log-scale between 'FDC' and 'Separate tablets'.~ANOVA on the log-scale: sequence, subjects within sequences, period and treatment as fixed effects"|Analysis with fixed effects for all terms||102.252|94.603|<0.0001
72589089|NCT03436693|144709290|OTHER|Point Estimate|Difference(Multiple imputation method)|11.3|||||TWO_SIDED|95.0|1.2|21.5||||||||21.5|1.2|
72589090|NCT03436693|144709291|OTHER|Point Estimate|Difference(Multiple imputation method)|3.8|||||TWO_SIDED|95.0|-4.1|11.7||||||||11.7|-4.1|
72589091|NCT03436693|144709292|SUPERIORITY||Difference of LSMean|1.09||||0.351|TWO_SIDED|95.0|-1.21|3.4|||Mixed Models Analysis|||||3.40|-1.21|0.351
72589092|NCT03436693|144709293|SUPERIORITY||Hazard Ratio (HR)|0.6||||0.293|TWO_SIDED|95.0|0.23|1.55|||Regression, Cox|||||1.55|0.23|0.293
72589093|NCT03436693|144709294|SUPERIORITY||Ratio of Geometric LSMean|0.52|||<|0.001|TWO_SIDED|95.0|0.418|0.646|||Mixed Models Analysis|||||0.646|0.418|<0.001
72589094|NCT04967885|144709318|SUPERIORITY|||||||0.24|||||||t-test, 2 sided|||||||0.24
72589095|NCT00626821|144709358|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.813|STANDARD_ERROR_OF_MEAN|0.133|<|0.0001|TWO_SIDED|95.0|1.553|2.073|||Mixed Models Analysis|||||2.073|1.553|<0.0001
72589096|NCT02632409|144709359|SUPERIORITY||Hazard Ratio (HR)|0.7||||0.0008|TWO_SIDED|98.22|0.55|0.9|||Stratified Cox Proportional hazard model|||||0.90|0.55|0.0008
72589097|NCT02632409|144709360|SUPERIORITY||Hazard Ratio (HR)|0.54||||0.0005|TWO_SIDED|98.72|0.35|0.84|||Stratified Cox Proportional hazard model|||||0.84|0.35|0.0005
72589098|NCT04016779|144709367|SUPERIORITY||Least Squares Mean Difference|-3.7|STANDARD_ERROR_OF_MEAN|1.28||0.004|TWO_SIDED|95.0|-6.2|-1.2|||Mixed Model for Repeated Measures|||||-1.2|-6.2|0.0040
72589099|NCT04016779|144709368|SUPERIORITY||Least Squares Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.14||0.0023|TWO_SIDED|95.0|-0.7|-0.2|||Mixed Model for Repeated Measures|||||-0.2|-0.7|0.0023
72589100|NCT04016779|144709369|SUPERIORITY||Difference in percentage of responders|5.6||||0.303|TWO_SIDED|95.0|-5.0|16.1|||Pearson's chi-squared test|||||16.1|-5.0|0.3030
72589101|NCT04016779|144709370|SUPERIORITY||Least Squares Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.12||0.0076|TWO_SIDED|95.0|-0.6|-0.1|||Mixed Model for Repeated Measures|||||-0.1|-0.6|0.0076
72589102|NCT04016779|144709371|SUPERIORITY||Difference in percentage of responders|10.7||||0.0744|TWO_SIDED|95.0|-1.0|22.1|||Pearson's chi-squared test|||||22.1|-1.0|0.0744
72589103|NCT04016779|144709372|SUPERIORITY||Least Squares Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.43||0.9205|TWO_SIDED|95.0|-0.9|0.8|||Mixed Model for Repeated Measures|||||0.8|-0.9|0.9205
72589104|NCT04016779|144709373|SUPERIORITY||Least Squares Mean Difference|-2.5|STANDARD_ERROR_OF_MEAN|0.77||0.0015|TWO_SIDED|95.0|-4.0|-0.9|||Mixed Model for Repeated Measures|||||-0.9|-4.0|0.0015
72589105|NCT04016779|144709374|SUPERIORITY||Least Squares Mean Difference|-1.4|STANDARD_ERROR_OF_MEAN|0.66||0.038|TWO_SIDED|95.0|-2.7|-0.1|||Mixed Model for Repeated Measures|||||-0.1|-2.7|0.0380
72589106|NCT04016779|144709375|SUPERIORITY||Difference in percentage of responders|12.4||||0.0395|TWO_SIDED|95.0|0.6|23.8|||Pearson's chi-squared test|||||23.8|0.6|0.0395
72589107|NCT04016779|144709376|SUPERIORITY||Difference in percentage of responders|6.4||||0.2736|TWO_SIDED|95.0|-5.0|17.5|||Pearson's chi-squared test|||||17.5|-5.0|0.2736
72589108|NCT04016779|144709377|SUPERIORITY||Least Square Mean Difference|-2.4|STANDARD_ERROR_OF_MEAN|1.22||0.0468|TWO_SIDED|95.0|-4.8|0.0|||ANCOVA|||||0.0|-4.8|0.0468
72589109|NCT04016779|144709378|SUPERIORITY||Least Square Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|1.04||0.4462|TWO_SIDED|95.0|-2.8|1.3|||ANCOVA|||||1.3|-2.8|0.4462
72589110|NCT04016779|144709379|SUPERIORITY||Least Square Mean Difference|-3.3|STANDARD_ERROR_OF_MEAN|1.29||0.01|TWO_SIDED|95.0|-5.9|-0.8|||ANCOVA|||||-0.8|-5.9|0.0100
72589111|NCT04016779|144709380|SUPERIORITY||Least Squares Mean Difference|-1.4|STANDARD_ERROR_OF_MEAN|1.16||0.2186|TWO_SIDED|95.0|-3.7|0.9|||ANCOVA|||||0.9|-3.7|0.2186
72589112|NCT04016779|144709381|SUPERIORITY||Least Squares Mean Difference|-2.3|STANDARD_ERROR_OF_MEAN|1.1||0.0344|TWO_SIDED|95.0|-4.5|-0.2|||ANCOVA|||||-0.2|-4.5|0.0344
72589113|NCT04016779|144709382|SUPERIORITY||Least Square Mean Difference|0.9|STANDARD_ERROR_OF_MEAN|0.99||0.368|TWO_SIDED|95.0|-1.1|2.8|||ANCOVA|||||2.8|-1.1|0.3680
72589114|NCT04016779|144709383|SUPERIORITY||Least Square Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|1.1||0.6361|TWO_SIDED|95.0|-2.7|1.6|||ANCOVA|||||1.6|-2.7|0.6361
72589115|NCT04016779|144709384|SUPERIORITY||Least Square Mean Difference|-1.6|STANDARD_ERROR_OF_MEAN|1.2||0.1708|TWO_SIDED|95.0|-4.0|0.7|||ANCOVA|||||0.7|-4.0|0.1708
72589116|NCT04016779|144709385|SUPERIORITY||Least Square Mean Difference|-3.4|STANDARD_ERROR_OF_MEAN|1.3||0.0094|TWO_SIDED|95.0|-6.0|-0.8|||ANCOVA|||||-0.8|-6.0|0.0094
72589117|NCT04016779|144709386|SUPERIORITY||Least Square Mean Difference|-3.4|STANDARD_ERROR_OF_MEAN|1.34||0.0104|TWO_SIDED|95.0|-6.1|-0.8|||ANCOVA|||||-0.8|-6.1|0.0104
72589118|NCT04016779|144709387|SUPERIORITY||Least Square Mean Difference|-2.7|STANDARD_ERROR_OF_MEAN|1.13||0.0178|TWO_SIDED|95.0|-4.9|-0.5|||ANCOVA|||||-0.5|-4.9|0.0178
72589119|NCT04016779|144709388|SUPERIORITY||Least Square Mean Difference|-3.2|STANDARD_ERROR_OF_MEAN|1.34||0.0187|TWO_SIDED|95.0|-5.8|-0.5|||ANCOVA|||||-0.5|-5.8|0.0187
72589120|NCT00910208|144709389|SUPERIORITY|||||||0.82|||||||ANOVA|||||||0.82
72589121|NCT00910208|144709390|SUPERIORITY|||||||0.47|||||||Chi-squared|||||||0.47
72589122|NCT00910208|144709391|SUPERIORITY|||||||0.06|||||||ANOVA|||||||0.06
72589123|NCT00910208|144709392|SUPERIORITY|||||||0.033|||||||Chi-squared|||||||0.033
72589124|NCT00910208|144709393|SUPERIORITY|||||||0.99|||||||Fisher Exact|||||||0.99
72589125|NCT00910208|144709394|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||<0.001
72589126|NCT02295020|144709395|SUPERIORITY_OR_OTHER|||||||0.181|||||||t-test, 2 sided|||||||0.181
72589127|NCT02295020|144709396|SUPERIORITY_OR_OTHER|||||||0.232|||||||t-test, 2 sided|||||||0.232
72589128|NCT02295020|144709397|SUPERIORITY_OR_OTHER|||||||0.311|||||||t-test, 2 sided|||||||0.311
72589129|NCT02295020|144709399|SUPERIORITY_OR_OTHER|||||||0.449|||||||t-test, 2 sided|||||||0.449
72589130|NCT02295020|144709400|SUPERIORITY_OR_OTHER|||||||0.86|||||||Wilcoxon (Mann-Whitney)|||||||0.860
72589131|NCT02295020|144709401|SUPERIORITY_OR_OTHER|||||||0.735|||||||Wilcoxon (Mann-Whitney)|||||||0.735
72589132|NCT02295020|144709402|SUPERIORITY_OR_OTHER|||||||0.479|||||||Wilcoxon (Mann-Whitney)|||||||0.479
72589133|NCT02295020|144709403|SUPERIORITY_OR_OTHER|||||||0.323|||||||Wilcoxon (Mann-Whitney)|||||||0.323
72589134|NCT02295020|144709404|SUPERIORITY_OR_OTHER|||||||0.878|||||||Wilcoxon (Mann-Whitney)|||||||0.878
72589135|NCT03514485|144709453|SUPERIORITY||Mean Difference (Final Values)|-0.04|||||TWO_SIDED|95.0|-0.34|0.25||||||Linear mixed effects models were then used to make the comparisons of all combinations of primary care and school-based interventions with respect to Asthma Control. Contrasts across time and levels of the intervention were obtained by subtraction. Models were not adjusted for timing of intervention delivery during the Coronavirus (COVID-19) pandemic.||0.25|-0.34|
72589136|NCT03514485|144709453|SUPERIORITY||Mean Difference (Final Values)|-0.08|||||TWO_SIDED|95.0|-0.34|0.18||||||Linear mixed effects models were then used to make the comparisons of all combinations of primary care and school-based interventions with respect to Asthma Control. Contrasts across time and levels of the intervention were obtained by subtraction. Models were not adjusted for timing of intervention delivery during the COVID-19 pandemic.||0.18|-0.34|
72589137|NCT03514485|144709453|SUPERIORITY||Mean Difference (Final Values)|-0.22|||||TWO_SIDED|95.0|-0.48|0.04||||||Linear mixed effects models were then used to make the comparisons of all combinations of primary care and school-based interventions with respect to Asthma Control. Contrasts across time and levels of the intervention were obtained by subtraction. Models were not adjusted for timing of intervention delivery during the COVID-19 pandemic.||0.04|-0.48|
72589138|NCT03514485|144709453|SUPERIORITY||Mean Difference (Final Values)|-0.18|||||TWO_SIDED|95.0|-0.44|0.9||||||Linear mixed effects models were then used to make the comparisons of all combinations of primary care and school-based interventions with respect to Asthma Control. Contrasts across time and levels of the intervention were obtained by subtraction. Models were not adjusted for timing of intervention delivery during the COVID-19 pandemic.||0.9|-0.44|
72589139|NCT03514485|144709453|SUPERIORITY||Mean Difference (Final Values)|-0.14|||||TWO_SIDED|95.0|-0.36|0.09||||||Linear mixed effects models were then used to make the comparisons of all combinations of primary care and school-based interventions with respect to Asthma Control. Contrasts across time and levels of the intervention were obtained by subtraction. Models were not adjusted for timing of intervention delivery during the COVID-19 pandemic.||0.09|-0.36|
72589140|NCT03514485|144709454|SUPERIORITY||Mean Difference (Net)|0.08|||||TWO_SIDED|95.0|-0.39|0.55||||||Mixed-effects generalized linear model with binomial family (n=14) was used to make the comparisons of all combinations of primary care and school-based interventions with respect to Daytime Symptoms. Contrasts across time and levels of the intervention were obtained by subtraction. Models were not adjusted for timing of intervention delivery during the Coronavirus (COVID-19) pandemic.||0.55|-0.39|
72589141|NCT03514485|144709454|SUPERIORITY||Mean Difference (Net)|0.46|||||TWO_SIDED|95.0|0.04|0.88||||||Mixed-effects generalized linear model with binomial family (n=14) was used to make the comparisons of all combinations of primary care and school-based interventions with respect to Daytime Symptoms. Contrasts across time and levels of the intervention were obtained by subtraction. Models were not adjusted for timing of intervention delivery during the Coronavirus (COVID-19) pandemic.||0.88|0.04|
72589142|NCT03514485|144709454|SUPERIORITY||Mean Difference (Net)|-0.65|||||TWO_SIDED|95.0|-1.06|-0.23||||||Mixed-effects generalized linear model with binomial family (n=14) was used to make the comparisons of all combinations of primary care and school-based interventions with respect to Daytime Symptoms. Contrasts across time and levels of the intervention were obtained by subtraction. Models were not adjusted for timing of intervention delivery during the Coronavirus (COVID-19) pandemic.||-0.23|-1.06|
72589143|NCT03514485|144709454|SUPERIORITY||Mean Difference (Net)|-1.03|||||TWO_SIDED|95.0|-1.39|-0.67||||||Mixed-effects generalized linear model with binomial family (n=14) was used to make the comparisons of all combinations of primary care and school-based interventions with respect to Daytime Symptoms. Contrasts across time and levels of the intervention were obtained by subtraction. Models were not adjusted for timing of intervention delivery during the Coronavirus (COVID-19) pandemic.||-0.67|-1.39|
72589144|NCT03514485|144709454|SUPERIORITY||Mean Difference (Net)|-0.57|||||TWO_SIDED|95.0|-0.95|-0.18||||||Mixed-effects generalized linear model with binomial family (n=14) was used to make the comparisons of all combinations of primary care and school-based interventions with respect to Daytime Symptoms. Contrasts across time and levels of the intervention were obtained by subtraction. Models were not adjusted for timing of intervention delivery during the Coronavirus (COVID-19) pandemic.||-0.18|-0.95|
72589145|NCT03514485|144709455|SUPERIORITY||Mean Difference (Net)|-0.13|||||TWO_SIDED|95.0|-0.53|0.28||||||Mixed-effects generalized linear model with binomial family (n=14) was used to make the comparisons of all combinations of primary care and school-based interventions with respect to Nighttime Symptoms. Contrasts across time and levels of the intervention were obtained by subtraction. Models were not adjusted for timing of intervention delivery during the Coronavirus (COVID-19) pandemic.||0.28|-0.53|
72589146|NCT03514485|144709455|SUPERIORITY||Median Difference (Net)|-0.09|||||TWO_SIDED|95.0|-0.45|0.26||||||Mixed-effects generalized linear model with binomial family (n=14) was used to make the comparisons of all combinations of primary care and school-based interventions with respect to Nighttime Symptoms. Contrasts across time and levels of the intervention were obtained by subtraction. Models were not adjusted for timing of intervention delivery during the Coronavirus (COVID-19) pandemic.||0.26|-0.45|
72589147|NCT03514485|144709455|SUPERIORITY||Mean Difference (Net)|-0.25|||||TWO_SIDED|95.0|-0.6|0.1||||||Mixed-effects generalized linear model with binomial family (n=14) was used to make the comparisons of all combinations of primary care and school-based interventions with respect to Nighttime Symptoms. Contrasts across time and levels of the intervention were obtained by subtraction. Models were not adjusted for timing of intervention delivery during the Coronavirus (COVID-19) pandemic.||0.10|-0.60|
72589148|NCT03514485|144709455|SUPERIORITY||Median Difference (Net)|-0.28|||||TWO_SIDED|95.0|-0.57|0.01||||||Mixed-effects generalized linear model with binomial family (n=14) was used to make the comparisons of all combinations of primary care and school-based interventions with respect to Nighttime Symptoms. Contrasts across time and levels of the intervention were obtained by subtraction. Models were not adjusted for timing of intervention delivery during the Coronavirus (COVID-19) pandemic.||0.01|-0.57|
72589149|NCT03514485|144709455|SUPERIORITY||Mean Difference (Net)|-0.38|||||TWO_SIDED|95.0|-0.72|-0.04||||||Mixed-effects generalized linear model with binomial family (n=14) was used to make the comparisons of all combinations of primary care and school-based interventions with respect to Nighttime Symptoms. Contrasts across time and levels of the intervention were obtained by subtraction. Models were not adjusted for timing of intervention delivery during the Coronavirus (COVID-19) pandemic.||-0.04|-0.72|
72589150|NCT03514485|144709456|SUPERIORITY||Mean Difference (Net)|2.38|||||TWO_SIDED|95.0|0.58|4.19||||||Mixed-effects generalized linear model with binomial family (n=number of school-days \[varies per child\]) was used to make the comparisons of all combinations of primary care and school-based interventions with respect to school absences. Contrasts across time and levels of the intervention were obtained by subtraction. Models were not adjusted for timing of intervention delivery during the Coronavirus (COVID-19) pandemic.||4.19|0.58|
72589151|NCT03514485|144709456|SUPERIORITY||Mean Difference (Net)|4.49|||||TWO_SIDED|95.0|2.54|6.43||||||Mixed-effects generalized linear model with binomial family (n=number of school-days \[varies per child\]) was used to make the comparisons of all combinations of primary care and school-based interventions with respect to school absences. Contrasts across time and levels of the intervention were obtained by subtraction. Models were not adjusted for timing of intervention delivery during the Coronavirus (COVID-19) pandemic.||6.43|2.54|
72589152|NCT03514485|144709456|SUPERIORITY||Mean Difference (Net)|-0.97|||||TWO_SIDED|95.0|-2.78|0.84||||||Mixed-effects generalized linear model with binomial family (n=number of school-days \[varies per child\]) was used to make the comparisons of all combinations of primary care and school-based interventions with respect to school absences. Contrasts across time and levels of the intervention were obtained by subtraction. Models were not adjusted for timing of intervention delivery during the Coronavirus (COVID-19) pandemic.||0.84|-2.78|
72589153|NCT03514485|144709456|SUPERIORITY||Mean Difference (Net)|-3.07|||||TWO_SIDED|95.0|-5.03|-1.12||||||Mixed-effects generalized linear model with binomial family (n=number of school-days \[varies per child\]) was used to make the comparisons of all combinations of primary care and school-based interventions with respect to school absences. Contrasts across time and levels of the intervention were obtained by subtraction. Models were not adjusted for timing of intervention delivery during the Coronavirus (COVID-19) pandemic.||-1.12|-5.03|
72589154|NCT03514485|144709456|SUPERIORITY||Mean Difference (Net)|1.41|||||TWO_SIDED|95.0|-0.48|3.31||||||Mixed-effects generalized linear model with binomial family (n=number of school-days \[varies per child\]) was used to make the comparisons of all combinations of primary care and school-based interventions with respect to school absences. Contrasts across time and levels of the intervention were obtained by subtraction. Models were not adjusted for timing of intervention delivery during the Coronavirus (COVID-19) pandemic.||3.31|-0.48|
72589155|NCT03514485|144709457|SUPERIORITY||Mean Difference (Net)|0.17|||||TWO_SIDED|95.0|-0.19|0.54||||||Mixed-effects negative binomial models were used to make the comparisons of all combinations of primary care and school-based interventions with respect to number of ED visits. Contrasts across time and levels of the intervention were obtained by subtraction. Models were not adjusted for timing of intervention delivery during the Coronavirus (COVID-19) pandemic.||0.54|-0.19|
72589156|NCT03514485|144709457|SUPERIORITY||Mean Difference (Net)|0.03|||||TWO_SIDED|95.0|-0.28|0.35||||||Mixed-effects negative binomial models were used to make the comparisons of all combinations of primary care and school-based interventions with respect to number of ED visits. Contrasts across time and levels of the intervention were obtained by subtraction. Models were not adjusted for timing of intervention delivery during the Coronavirus (COVID-19) pandemic.||0.35|-0.28|
72414132|NCT05437510|144337242|SUPERIORITY||Efficacy|85.2||||0.0004|TWO_SIDED|95.0|50.084|97.183|||Exact method using binomial distribution|||"Statistical analysis for UK:~The 2-sided 95% CI for the efficacy was calculated by an exact method assuming a binomial distribution of the number of RSV LRTI hospitalizations in the nirsevimab group conditional on the total number in both groups accounting for the follow-up time post-dosing/randomization."||97.183|50.084|0.0004
72589157|NCT03514485|144709457|SUPERIORITY||Mean Difference (Net)|-0.34|||||TWO_SIDED|95.0|-0.68|-0.01||||||Mixed-effects negative binomial models were used to make the comparisons of all combinations of primary care and school-based interventions with respect to number of ED visits. Contrasts across time and levels of the intervention were obtained by subtraction. Models were not adjusted for timing of intervention delivery during the Coronavirus (COVID-19) pandemic.||-0.01|-0.68|
72589158|NCT03514485|144709457|SUPERIORITY||Mean Difference (Net)|-0.2|||||TWO_SIDED|95.0|-0.48|0.08||||||Mixed-effects negative binomial models were used to make the comparisons of all combinations of primary care and school-based interventions with respect to number of ED visits. Contrasts across time and levels of the intervention were obtained by subtraction. Models were not adjusted for timing of intervention delivery during the Coronavirus (COVID-19) pandemic.||0.08|-0.48|
72589159|NCT03514485|144709457|SUPERIORITY||Mean Difference (Net)|-0.17|||||TWO_SIDED|95.0|-0.48|0.14||||||Mixed-effects negative binomial models were used to make the comparisons of all combinations of primary care and school-based interventions with respect to number of ED visits. Contrasts across time and levels of the intervention were obtained by subtraction. Models were not adjusted for timing of intervention delivery during the Coronavirus (COVID-19) pandemic.||0.14|-0.48|
72589160|NCT03514485|144709458|SUPERIORITY||Mean Difference (Net)|0.09|||||TWO_SIDED|95.0|-0.11|0.29||||||Mixed-effects negative binomial models were used to make the comparisons of all combinations of primary care and school-based interventions with respect to number of hospitalizations. Contrasts across time and levels of the intervention were obtained by subtraction. Models were not adjusted for timing of intervention delivery during the Coronavirus (COVID-19) pandemic.||0.29|-0.11|
72589161|NCT03514485|144709458|SUPERIORITY||Mean Difference (Net)|0.16|||||TWO_SIDED|95.0|-0.03|0.34||||||Mixed-effects negative binomial models were used to make the comparisons of all combinations of primary care and school-based interventions with respect to number of hospitalizations. Contrasts across time and levels of the intervention were obtained by subtraction. Models were not adjusted for timing of intervention delivery during the Coronavirus (COVID-19) pandemic.||0.34|-0.03|
72589162|NCT03514485|144709458|SUPERIORITY||Mean Difference (Net)|-0.001|||||TWO_SIDED|95.0|-0.19|0.18||||||Mixed-effects negative binomial models were used to make the comparisons of all combinations of primary care and school-based interventions with respect to number of hospitalizations. Contrasts across time and levels of the intervention were obtained by subtraction. Models were not adjusted for timing of intervention delivery during the Coronavirus (COVID-19) pandemic.||0.18|-0.19|
72589163|NCT03514485|144709458|SUPERIORITY||Mean Difference (Net)|-0.07|||||TWO_SIDED|95.0|-0.23|0.09||||||Mixed-effects negative binomial models were used to make the comparisons of all combinations of primary care and school-based interventions with respect to number of hospitalizations. Contrasts across time and levels of the intervention were obtained by subtraction. Models were not adjusted for timing of intervention delivery during the Coronavirus (COVID-19) pandemic.||0.09|-0.23|
72589164|NCT03514485|144709458|SUPERIORITY||Mean Difference (Net)|0.09|||||TWO_SIDED|95.0|-0.09|0.26||||||Mixed-effects negative binomial models were used to make the comparisons of all combinations of primary care and school-based interventions with respect to number of hospitalizations. Contrasts across time and levels of the intervention were obtained by subtraction. Models were not adjusted for timing of intervention delivery during the Coronavirus (COVID-19) pandemic.||0.26|-0.09|
72589165|NCT03514485|144709459|SUPERIORITY||Mean Difference (Net)|0.32|||||TWO_SIDED|95.0|0.0|0.65||||||Mixed-effects linear models with random intercepts for school and child were used to make the comparisons of all combinations of primary care and school-based interventions with respect to QOL emotional functioning domain. Contrasts across time and levels of the intervention were obtained by subtraction. Models were not adjusted for timing of intervention delivery during the Coronavirus (COVID-19) pandemic.||0.65|0.00|
72589166|NCT03514485|144709459|SUPERIORITY||Mean Difference (Net)|0.16|||||TWO_SIDED|95.0|-0.12|0.45||||||Mixed-effects linear models with random intercepts for school and child were used to make the comparisons of all combinations of primary care and school-based interventions with respect to QOL emotional functioning domain. Contrasts across time and levels of the intervention were obtained by subtraction. Models were not adjusted for timing of intervention delivery during the Coronavirus (COVID-19) pandemic.||0.45|-0.12|
72589167|NCT03514485|144709459|SUPERIORITY||Mean Difference (Net)|-0.11|||||TWO_SIDED|95.0|-0.4|0.18||||||Mixed-effects linear models with random intercepts for school and child were used to make the comparisons of all combinations of primary care and school-based interventions with respect to QOL emotional functioning domain. Contrasts across time and levels of the intervention were obtained by subtraction. Models were not adjusted for timing of intervention delivery during the Coronavirus (COVID-19) pandemic.||0.18|-0.40|
72589168|NCT03514485|144709459|SUPERIORITY||Mean Difference (Net)|0.05|||||TWO_SIDED|95.0|-0.2|0.29||||||Mixed-effects linear models with random intercepts for school and child were used to make the comparisons of all combinations of primary care and school-based interventions with respect to QOL emotional functioning domain. Contrasts across time and levels of the intervention were obtained by subtraction. Models were not adjusted for timing of intervention delivery during the Coronavirus (COVID-19) pandemic.||0.29|-0.20|
72589169|NCT03514485|144709459|SUPERIORITY||Mean Difference (Net)|0.21|||||TWO_SIDED|95.0|-0.08|0.5||||||Mixed-effects linear models with random intercepts for school and child were used to make the comparisons of all combinations of primary care and school-based interventions with respect to QOL emotional functioning domain. Contrasts across time and levels of the intervention were obtained by subtraction. Models were not adjusted for timing of intervention delivery during the Coronavirus (COVID-19) pandemic.||0.50|-0.08|
72589170|NCT03514485|144709460|SUPERIORITY||Mean Difference (Net)|0.25|||||TWO_SIDED|95.0|-0.19|0.69||||||Mixed-effects linear models with random intercepts for school and child were used to make the comparisons of all combinations of primary care and school-based interventions with respect to QOL activity limitations domain. Contrasts across time and levels of the intervention were obtained by subtraction. Models were not adjusted for timing of intervention delivery during the Coronavirus (COVID-19) pandemic.||0.69|-0.19|
72589171|NCT03514485|144709460|SUPERIORITY||Mean Difference (Net)|0.25|||||TWO_SIDED|95.0|-0.14|0.63||||||Mixed-effects linear models with random intercepts for school and child were used to make the comparisons of all combinations of primary care and school-based interventions with respect to QOL activity limitations domain. Contrasts across time and levels of the intervention were obtained by subtraction. Models were not adjusted for timing of intervention delivery during the Coronavirus (COVID-19) pandemic.||0.63|-0.14|
72589172|NCT03514485|144709460|SUPERIORITY||Mean Difference (Net)|-0.1|||||TWO_SIDED|95.0|-0.49|0.3||||||Mixed-effects linear models with random intercepts for school and child were used to make the comparisons of all combinations of primary care and school-based interventions with respect to QOL activity limitations domain. Contrasts across time and levels of the intervention were obtained by subtraction. Models were not adjusted for timing of intervention delivery during the Coronavirus (COVID-19) pandemic.||0.30|-0.49|
72589173|NCT03514485|144709460|SUPERIORITY||Mean Difference (Net)|-0.1|||||TWO_SIDED|95.0|-0.43|0.24||||||Mixed-effects linear models with random intercepts for school and child were used to make the comparisons of all combinations of primary care and school-based interventions with respect to QOL activity limitations domain. Contrasts across time and levels of the intervention were obtained by subtraction. Models were not adjusted for timing of intervention delivery during the Coronavirus (COVID-19) pandemic.||0.24|-0.43|
72589174|NCT03514485|144709460|SUPERIORITY||Mean Difference (Net)|0.15|||||TWO_SIDED|95.0|-0.24|0.54||||||Mixed-effects linear models with random intercepts for school and child were used to make the comparisons of all combinations of primary care and school-based interventions with respect to QOL activity limitations domain. Contrasts across time and levels of the intervention were obtained by subtraction. Models were not adjusted for timing of intervention delivery during the Coronavirus (COVID-19) pandemic.||0.54|-0.24|
72589175|NCT00791661|144709465|SUPERIORITY_OR_OTHER||Geometric mean ratio (fed/fasted)|0.92||||||95.0|||||Mixed-effect model|Based on mixed effect model with panel and treatment-within-panel as fixed effects and participant-within panel as a random effect.||||||
72414133|NCT05437510|144337242|SUPERIORITY||Efficacy|74.36||||0.0055|TWO_SIDED|95.0|29.006|92.518|||Exact method using binomial distribution|||"Statistical analysis for Germany:~The 2-sided 95% CI for the efficacy was calculated by an exact method assuming a binomial distribution of the number of RSV LRTI hospitalizations in the nirsevimab group conditional on the total number in both groups accounting for the follow-up time post-dosing/randomization."||92.518|29.006|0.0055
72589176|NCT00791661|144709467|SUPERIORITY_OR_OTHER||Geometric mean ratio (fed/fasted)|0.81||||||95.0|||||Mixed-effect model|Based on mixed effect model with panel and treatment-within-panel as fixed effects and participant-within panel as a random effect.||||||
72589177|NCT00791661|144709471|SUPERIORITY_OR_OTHER||Difference in least squares mean|-8.1||||0.368|TWO_SIDED|90.0|-23.0|6.8||A step down procedure starting with the highest tolerated dose was implemented.|Mixed Models Analysis|Based on mixed effect model with glucose baseline, panel and treatment-within-panel as fixed effects and participant-within panel as a random effect.|The calculation used to determine the difference in least squares mean (LS mean) was LS mean for MK-1006 15 mg minus LS mean for placebo.|At one or more well tolerated single doses of MK-1006, the 24-hour weighted mean glucose concentration is expected to be at least 25 mg/dL lower than placebo.||6.8|-23.0|0.368
72589178|NCT00791661|144709471|SUPERIORITY_OR_OTHER||Difference in least squares mean|-16.6||||0.079|TWO_SIDED|90.0|-32.2|-1.1||A step down procedure starting with the highest tolerated dose was implemented.|Mixed Models Analysis|Based on mixed effect model with glucose baseline, panel and treatment-within-panel as fixed effects and participant-within panel as a random effect.|The calculation used to determine the difference in least squares mean (LS mean) was LS mean for MK-1006 30 mg minus LS mean for placebo.|At one or more well tolerated single doses of MK-1006, the 24-hour weighted mean glucose concentration is expected to be at least 25 mg/dL lower than placebo.||-1.1|-32.2|0.079
72414134|NCT05437510|144337243|SUPERIORITY||Efficacy|75.31||||0.0013|TWO_SIDED|95.0|38.012|91.747|||Exact method using binomial distribution|||"Statistical analysis for Overall:~The 2-sided 95% CI for the efficacy was calculated by an exact method assuming a binomial distribution of the number of very severe RSV LRTI through Day 151 post-dosing/randomization in the nirsevimab group conditional on the total number in both groups accounting for the follow-up time post-dosing/randomization."||91.747|38.012|0.0013
72589179|NCT00791661|144709471|SUPERIORITY_OR_OTHER||Difference in least squares mean|-25.7||||0.007|TWO_SIDED|90.0|-40.9|-10.5||A step down procedure starting with the highest tolerated dose was implemented.|Mixed Models Analysis|Based on mixed effect model with glucose baseline, panel and treatment-within-panel as fixed effects and participant-within panel as a random effect.|The calculation used to determine the difference in least squares mean (LS mean) was LS mean for MK-1006 45 mg minus LS mean for placebo.|At one or more well tolerated single doses of MK-1006, the 24-hour weighted mean glucose concentration is expected to be at least 25 mg/dL lower than placebo.||-10.5|-40.9|0.007
72589180|NCT00791661|144709471|SUPERIORITY_OR_OTHER||Diffrence in least squares mean|-36.3|||<|0.001|TWO_SIDED|90.0|-52.0|-20.5||A step down procedure starting with the highest tolerated dose was implemented.|Mixed Models Analysis|Based on mixed effect model with glucose baseline, panel and treatment-within-panel as fixed effects and participant-within panel as a random effect.|The calculation used to determine the difference in least squares mean (LS mean) was LS mean for MK-1006 60 mg minus LS mean for placebo.|At one or more well tolerated single doses of MK-1006, the 24-hour weighted mean glucose concentration is expected to be at least 25 mg/dL lower than placebo.||-20.5|-52.0|<.001
72589181|NCT00791661|144709471|SUPERIORITY_OR_OTHER||Difference in least squares mean|-19.7||||0.147|TWO_SIDED|90.0|-42.2|2.7|||Mixed Models Analysis|Based on mixed effect model with glucose baseline, panel and treatment-within-panel as fixed effects and participant-within panel as a random effect.|The calculation used to determine the difference in least squares mean (LS mean) was LS mean for MK-1006 60 mg fed minus LS mean for placebo fed.|||2.7|-42.2|0.147
72589182|NCT00791661|144709471|SUPERIORITY_OR_OTHER||Difference in least squares mean|12.3||||0.114|TWO_SIDED|90.0|-0.5|25.2|||Mixed Models Analysis|Based on mixed effect model with glucose baseline, panel and treatment-within-panel as fixed effects and participant-within panel as a random effect.|Difference in least squares mean (LS mean) was calculated as LS mean for MK-1006 60 mg minus LS mean for MK-1006 60 mg fed.|||25.2|-0.5|0.114
72589183|NCT00791661|144709471|SUPERIORITY_OR_OTHER||Difference in least squares mean|-28.9||||0.026|TWO_SIDED|90.0|-49.9|-7.9|||Mixed Models Analysis|Based on mixed effect model with glucose baseline, panel and treatment-within-panel as fixed effects and participant-within panel as a random effect.|The calculation used to determine the difference in least squares mean (LS mean) was LS mean for placebo fed minus LS mean for placebo.|||-7.9|-49.9|0.026
72589184|NCT00791661|144709471|SUPERIORITY_OR_OTHER||Difference in least squares mean|-57.6|||<|0.001|TWO_SIDED|90.0|-73.3|-41.9||A step down procedure starting with the highest tolerated dose was implemented.|Mixed Models Analysis|Based on mixed effect model with glucose baseline, panel and treatment-within-panel as fixed effects and participant-within panel as a random effect.|The calculation used to determine the difference in least squares mean (LS mean) was LS mean for MK-1006 80 mg minus LS mean for placebo.|At one or more well tolerated single doses of MK-1006, the 24-hour weighted mean glucose concentration is expected to be at least 25 mg/dL lower than placebo.||-41.9|-73.3|<.001
72589185|NCT00791661|144709471|SUPERIORITY_OR_OTHER||Difference in least squares mean|-15.3||||0.099|TWO_SIDED|90.0|-30.5|-0.1||A step down procedure starting with the highest tolerated dose was implemented.|Mixed Models Analysis|Based on mixed effect model with glucose baseline, panel and treatment-within-panel as fixed effects and participant-within panel as a random effect.|The calculation used to determine the difference in least squares mean (LS mean) was LS mean for MK-1006 100 mg minus LS mean for placebo.|At one or more well tolerated single doses of MK-1006, the 24-hour weighted mean glucose concentration is expected to be at least 25 mg/dL lower than placebo.||-0.1|-30.5|0.099
72589186|NCT00791661|144709471|SUPERIORITY_OR_OTHER||Difference in least squares mean|-43.9|||<|0.001|TWO_SIDED|90.0|-60.8|-27.0||A step down procedure starting with the highest tolerated dose was implemented.|Mixed Models Analysis|Based on mixed effect model with glucose baseline, panel and treatment-within-panel as fixed effects and participant-within panel as a random effect.|The calculation used to determine the difference in least squares mean (LS mean) was LS mean for MK-1006 140 mg minus LS mean for placebo.|At one or more well tolerated single doses of MK-1006, the 24-hour weighted mean glucose concentration is expected to be at least 25 mg/dL lower than placebo.||-27.0|-60.8|<.001
72589187|NCT00791661|144709471|SUPERIORITY_OR_OTHER||Difference in least squares mean|-59.4|||<|0.001|TWO_SIDED|90.0|-75.1|-43.7||A step down procedure starting with the highest tolerated dose was implemented.|Mixed Models Analysis|Based on mixed effect model with glucose baseline, panel and treatment-within-panel as fixed effects and participant-within panel as a random effect.|The calculation used to determine the difference in least squares mean (LS mean) was LS mean for MK-1006 170 mg minus LS mean for placebo.|At one or more well tolerated single doses of MK-1006, the 24-hour weighted mean glucose concentration is expected to be at least 25 mg/dL lower than placebo.||-43.7|-75.1|<.001
72589188|NCT00937040|144709477|SUPERIORITY_OR_OTHER||||||<|0.001||||||P-value was determined by using an ANCOVA model with factors treatment and pooled study center, and covariate baseline AISRS total score. Change from baseline to endpoint uses the latest non-missing score after baseline for each subject.|ANCOVA|P-value for Change from baseline at endpoint. Each outcome involved with gate-keeping will be numbered with a Gate-Keeper-Sequence-Number from 01-16.||Gate-Keeper-Sequence#01. The primary efficacy was tested at the 0.05 level of significance. To control the overall Type I error at 0.05, the secondary efficacy endpoints were tested in a fixed sequence if the preceding null hypothesis was rejected. No further hypotheses could be tested when the preceding null hypothesis was not rejected. All nominal p-values were presented even though the formal testing procedure stopped at the primary endpoint. No unqualified statements can be made.||||<0.001
72589189|NCT00937040|144709478|SUPERIORITY_OR_OTHER|||||||0.206||95.0||||P-value was determined by using an ANCOVA model with factors treatment and pooled study center, and covariate baseline score. Endpoint for extended day sites is the 4 hour timepoint and for other sites is the last non-missing value after baseline.|ANCOVA|P-value for Change from baseline at endpoint.||Gate-Keeper-Sequence-Number#02.||||0.206
72589190|NCT00937040|144709479|SUPERIORITY_OR_OTHER|||||||0.348||95.0||||P-value was determined by using an ANCOVA model with factors treatment and pooled study center, and covariate baseline score. Endpoint for extended day sites is the 4 hour timepoint and for other sites is the last non-missing value after baseline.|ANCOVA|P-value for Change from baseline at endpoint.||Gate-Keeper-Sequence-Number#03.||||0.348
72589191|NCT00937040|144709480|SUPERIORITY_OR_OTHER|||||||0.324||95.0||||P-value was determined by using an ANCOVA model with factors treatment and pooled study center, and covariate baseline score. Endpoint for extended day sites is the 4 hour timepoint and for other sites is the last non-missing value after baseline.|ANCOVA|P-value for Change from baseline at endpoint.||Gate-Keeper-Sequence-Number#04.||||0.324
72589192|NCT00937040|144709481|SUPERIORITY_OR_OTHER|||||||0.631||95.0||||P-value was determined by using an ANCOVA model with factors treatment and pooled study center, and covariate baseline score. Endpoint for extended day sites is the 4 hour timepoint and for other sites is the last non-missing value after baseline.|ANCOVA|P-value for Change from baseline at endpoint.||Gate-Keeper-Sequence-Number#05.||||0.631
72589193|NCT00937040|144709482|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value was determined by using an ANCOVA model with factors treatment and pooled study center, and covariate baseline score.|ANCOVA|P-value for Change from baseline at endpoint.||Gate-Keeper-Sequence-Number#06.||||<0.001
72589194|NCT00937040|144709483|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value was determined by using an ANCOVA model with factors treatment and pooled study center, and covariate baseline score.|ANCOVA|P-value for Change from baseline at endpoint.||Gate-Keeper-Sequence-Number#07.||||<0.001
72589195|NCT00937040|144709484|SUPERIORITY_OR_OTHER|||||||0.008||95.0||||P-value was determined by using an ANCOVA model with factors treatment and pooled study center, and covariate baseline score.|ANCOVA|P-value for Change from baseline at endpoint.||Gate-Keeper-Sequence-Number#08.||||0.008
72589196|NCT00937040|144709485|SUPERIORITY_OR_OTHER|||||||0.372||95.0||||P-value was determined by using an ANCOVA model with factors treatment and pooled study center, and covariate baseline score.|ANCOVA|P-value for Change from baseline at endpoint.||Gate-Keeper-Sequence-Number#09.||||0.372
72589197|NCT00937040|144709486|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value was determined by using the Cochran-Mantel-Haenszel (CMH) row mean scores controlling for center.|Cochran-Mantel-Haenszel|P-value for Change from baseline at endpoint.||Gate-Keeper-Sequence-Number#10.||||<0.001
72589198|NCT00937040|144709487|SUPERIORITY_OR_OTHER|||||||0.008||95.0||||P-value was determined using CMH general association controlling for pooled center.|Cochran-Mantel-Haenszel|P-value for Change from baseline at endpoint.||Gate-Keeper-Sequence-Number#11.||||0.008
72589199|NCT00937040|144709488|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value was determined by using an ANCOVA model with factors treatment and pooled study center, and covariate baseline score.|ANCOVA|P-value for Change from baseline at endpoint.||Gate-Keeper-Sequence-Number#12.||||<0.001
72589200|NCT00937040|144709489|SUPERIORITY_OR_OTHER|||||||0.003||95.0||||P-value was determined by using an ANCOVA model with factors treatment and pooled study center, and covariate baseline score.|ANCOVA|P-value for Change from baseline at endpoint.||Gate-Keeper-Sequence-Number#13.||||0.003
72589201|NCT00937040|144709490|SUPERIORITY_OR_OTHER|||||||0.016||95.0||||P-value was determined by using an ANCOVA model with factors treatment and pooled study center, and covariate baseline score.|ANCOVA|P-value for Change from baseline at endpoint.||Gate-Keeper-Sequence-Number#14.||||0.016
72589202|NCT00937040|144709491|SUPERIORITY_OR_OTHER|||||||0.092||95.0||||P-value was determined by using an ANCOVA model with factors treatment and pooled study center, and covariate baseline score.|ANCOVA|P-value for Change from baseline at endpoint.||Gate-Keeper-Sequence-Number#15.||||0.092
72589203|NCT00937040|144709492|SUPERIORITY_OR_OTHER|||||||0.284||95.0||||P-value was determined by using the Cochran-Mantel-Haenszel (CMH) row mean scores controlling for center. Missing/unknown responses are not included in the p-value.|Cochran-Mantel-Haenszel|P-value for Change from baseline at endpoint.||Gate-Keeper-Sequence-Number#16.||||0.284
72589204|NCT00937040|144709493|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value was determined by using an ANCOVA model with factors treatment and pooled study center, and covariate baseline score.|ANCOVA|||P-value for Change from baseline at endpoint||||<0.001
72589205|NCT00937040|144709494|SUPERIORITY_OR_OTHER|||||||0.319||95.0||||P-value was determined by using an ANCOVA model with factors treatment and pooled study center, and covariate baseline score.|ANCOVA|||P-value for Change from baseline at endpoint||||0.319
72589206|NCT00937040|144709495|SUPERIORITY_OR_OTHER|||||||0.007||95.0||||P-value was determined by using an ANCOVA model with factors treatment and pooled study center, and covariate baseline score.|ANCOVA|||P-value for Change from baseline at endpoint||||0.007
72589207|NCT02120833|144709615|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||The significance level threshold level was 0.05 (two-sided).|One-sample t-test|Adjusted by study site.||The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline.||||<0.0001
72589208|NCT02120833|144709615|SUPERIORITY_OR_OTHER|||||||0.436|TWO_SIDED|||||The significance level threshold level was 0.05 (two-sided).|One-sample t-test|Adjusted by study site.||The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline.||||0.4360
72589209|NCT02120833|144709615|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.25|STANDARD_ERROR_OF_MEAN|0.62||0.051|TWO_SIDED|95.0|-2.51|0.01||The significance threshold level was 0.05 (two-sided).|ANCOVA|Treatment and study site as factors, baseline score as covariate.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.01|-2.51|0.0510
72589210|NCT02120833|144709616|SUPERIORITY_OR_OTHER|||||||0.0004|TWO_SIDED|||||The significance level threshold level was 0.05 (two-sided).|One-sample t-test|Adjusted by study site.||The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline.||||0.0004
72589211|NCT02120833|144709616|SUPERIORITY_OR_OTHER|||||||0.0213|TWO_SIDED|||||The significance level threshold level was 0.05 (two-sided).|One-sample t-test|Adjusted by study site.||The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline.||||0.0213
72589212|NCT02120833|144709616|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.06|STANDARD_ERROR_OF_MEAN|0.22||0.7698|TWO_SIDED|95.0|-0.5|0.37|||ANCOVA|The significance threshold level was 0.05 (two-sided).||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.37|-0.50|0.7698
72589213|NCT02120833|144709617|SUPERIORITY_OR_OTHER|||||||0.0003|TWO_SIDED|||||The significance level threshold level was 0.05 (two-sided).|One-sample t-test|Adjusted by study site.||The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline.||||0.0003
72589214|NCT02120833|144709617|SUPERIORITY_OR_OTHER|||||||0.6063|TWO_SIDED|||||The significance level threshold level was 0.05 (two-sided).|One-sample t-test|Adjusted by study site.||The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline.||||0.6063
72589215|NCT02120833|144709617|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.39|STANDARD_ERROR_OF_MEAN|0.43||0.3686|TWO_SIDED|95.0|-1.27|0.48||The significance threshold level was 0.05 (two-sided).|ANCOVA|Treatment and study site as factors, baseline score as covariate.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.48|-1.27|0.3686
72589216|NCT02120833|144709618|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||The significance level threshold level was 0.05 (two-sided).|One-sample t-test|Adjusted by study site.||The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline.||||<0.0001
72589217|NCT02120833|144709618|SUPERIORITY_OR_OTHER|||||||0.6118|TWO_SIDED|||||The significance level threshold level was 0.05 (two-sided).|One-sample t-test|Adjusted by study site.||The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline.||||0.6118
72589218|NCT02120833|144709618|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.83|STANDARD_ERROR_OF_MEAN|0.56||0.1485|TWO_SIDED|95.0|-1.98|0.31||The significance threshold level was 0.05 (two-sided).|ANCOVA|Treatment and study site as factors, baseline score as covariate.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.31|-1.98|0.1485
72589219|NCT02120833|144709619|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||The significance level threshold level was 0.05 (two-sided).|One-sample t-test|Adjusted by study site.||The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline.||||<0.0001
72589220|NCT02120833|144709619|SUPERIORITY_OR_OTHER|||||||0.2447|TWO_SIDED|||||The significance level threshold level was 0.05 (two-sided).|One-sample t-test|Adjusted by study site.||The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline.||||0.2447
72589221|NCT02120833|144709619|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.6|STANDARD_ERROR_OF_MEAN|0.67||0.0216|TWO_SIDED|95.0|-2.95|-0.25||The significance threshold level was 0.05 (two-sided).|ANCOVA|Treatment and study site as factors, baseline score as covariate.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||-0.25|-2.95|0.0216
72589222|NCT02120833|144709620|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||The significance level threshold level was 0.05 (two-sided).|One-sample t-test|Adjusted by study site.||The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline.||||<0.0001
72589223|NCT02120833|144709620|SUPERIORITY_OR_OTHER|||||||0.0476|TWO_SIDED|||||The significance level threshold level was 0.05 (two-sided).|One-sample t-test|Adjusted by study site.||The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline.||||0.0476
72589224|NCT02120833|144709620|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.94|STANDARD_ERROR_OF_MEAN|0.78||0.2349|TWO_SIDED|95.0|-2.52|0.64||The significance threshold level was 0.05 (two-sided).|ANCOVA|Treatment and study site as factors, baseline score as covariate.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.64|-2.52|0.2349
72589225|NCT02120833|144709621|SUPERIORITY_OR_OTHER|||||||0.7842|TWO_SIDED|||||The significance level threshold level was 0.05 (two-sided).|One-sample t-test|Adjusted by study site.||The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline.||||0.7842
72589226|NCT02120833|144709621|SUPERIORITY_OR_OTHER|||||||0.6083|TWO_SIDED|||||The significance level threshold level was 0.05 (two-sided).|One-sample t-test|Adjusted by study site.||The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline.||||0.6083
72589227|NCT02120833|144709621|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.07|STANDARD_ERROR_OF_MEAN|0.07||0.3599|TWO_SIDED|95.0|-0.08|0.22||The significance threshold level was 0.05 (two-sided).|ANCOVA|Treatment and study site as factors, baseline score as covariate.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.22|-0.08|0.3599
72589228|NCT02120833|144709622|SUPERIORITY_OR_OTHER|||||||0.0001|TWO_SIDED|||||The significance level threshold level was 0.05 (two-sided).|One-sample t-test|Adjusted by study site.||The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline.||||0.0001
72589229|NCT02120833|144709622|SUPERIORITY_OR_OTHER|||||||0.0317|TWO_SIDED|||||The significance level threshold level was 0.05 (two-sided).|One-sample t-test|Adjusted by study site.||The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline.||||0.0317
72589230|NCT02120833|144709622|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.19||0.8037|TWO_SIDED|95.0|-0.42|0.33||The significance threshold level was 0.05 (two-sided).|ANCOVA|Treatment and study site as factors, baseline score as covariate.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.33|-0.42|0.8037
72589231|NCT02120833|144709623|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||The significance level threshold level was 0.05 (two-sided).|One-sample t-test|Adjusted by study site.||The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline.||||<0.0001
72589232|NCT02120833|144709623|SUPERIORITY_OR_OTHER|||||||0.0244|TWO_SIDED|||||The significance level threshold level was 0.05 (two-sided).|One-sample t-test|Adjusted by study site.||The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline.||||0.0244
72589233|NCT02120833|144709623|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.37|STANDARD_ERROR_OF_MEAN|0.21||0.09|TWO_SIDED|95.0|-0.8|0.06||The significance threshold level was 0.05 (two-sided).|ANCOVA|Treatment and study site as factors, baseline score as covariate.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.06|-0.80|0.0900
72589234|NCT02120833|144709624|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||The significance level threshold level was 0.05 (two-sided).|One-sample t-test|Adjusted by study site.||The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline.||||<0.0001
72589235|NCT02120833|144709624|SUPERIORITY_OR_OTHER|||||||0.0065|TWO_SIDED|||||The significance level threshold level was 0.05 (two-sided).|One-sample t-test|Adjusted by study site.||The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline.||||0.0065
72589236|NCT02120833|144709624|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.28||0.1561|TWO_SIDED|95.0|-0.97|0.16||The significance threshold level was 0.05 (two-sided).|ANCOVA|Treatment and study site as factors, baseline score as covariate.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.16|-0.97|0.1561
72589237|NCT02120833|144709625|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||The significance level threshold level was 0.05 (two-sided).|One-sample t-test|Adjusted by study site.||The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline.||||<0.0001
72589238|NCT02120833|144709625|SUPERIORITY_OR_OTHER|||||||0.0049|TWO_SIDED|||||The significance level threshold level was 0.05 (two-sided).|One-sample t-test|Adjusted by study site.||The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline.||||0.0049
72414135|NCT05437510|144337243|SUPERIORITY||Efficacy|78.1||||0.062|TWO_SIDED|95.0|-5.823|97.697|||Exact method using binomial distribution|||"Statistical analysis for France:~The 2-sided 95% CI for the efficacy was calculated by an exact method assuming a binomial distribution of the number of very severe RSV LRTI through Day 151 post-dosing/randomization in the nirsevimab group conditional on the total number in both groups accounting for the follow-up time post-dosing/randomization."||97.697|-5.823|0.0620
72589239|NCT02120833|144709625|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.59|STANDARD_ERROR_OF_MEAN|4.71||0.2409|TWO_SIDED|95.0|-3.88|15.07||The significance threshold level was 0.05 (two-sided).|ANCOVA|Treatment and study site as factors, baseline score as covariate.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||15.07|-3.88|0.2409
72589240|NCT02120833|144709626|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||The significance level threshold level was 0.05 (two-sided).|One-sample t-test|Adjusted by study site.||The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline.||||<0.0001
72589241|NCT02120833|144709626|SUPERIORITY_OR_OTHER|||||||0.2386|TWO_SIDED|||||The significance level threshold level was 0.05 (two-sided).|One-sample t-test|Adjusted by study site.||The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline.||||0.2386
72589242|NCT02120833|144709626|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.3|STANDARD_ERROR_OF_MEAN|3.98||0.0241|TWO_SIDED|95.0|1.28|17.32||The significance threshold level was 0.05 (two-sided).|ANCOVA|Treatment and study site as factors, baseline score as covariate.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||17.32|1.28|0.0241
72589243|NCT02120833|144709627|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||The significance level threshold level was 0.05 (two-sided).|One-sample t-test|Adjusted by study site.||The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline.||||<0.0001
72589244|NCT02120833|144709627|SUPERIORITY_OR_OTHER|||||||0.0696|TWO_SIDED|||||The significance level threshold level was 0.05 (two-sided).|One-sample t-test|Adjusted by study site.||The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline.||||0.0696
72589245|NCT02120833|144709627|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.99|STANDARD_ERROR_OF_MEAN|4.23||0.0394|TWO_SIDED|95.0|0.46|17.52||The significance threshold level was 0.05 (two-sided).|ANCOVA|Treatment and study site as factors, baseline score as covariate.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||17.52|0.46|0.0394
72589246|NCT02120833|144709628|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||The significance level threshold level was 0.05 (two-sided).|One-sample t-test|Adjusted by study site.||The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline.||||<0.0001
72589247|NCT02120833|144709628|SUPERIORITY_OR_OTHER|||||||0.0772|TWO_SIDED|||||The significance level threshold level was 0.05 (two-sided).|One-sample t-test|Adjusted by study site.||The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline.||||0.0772
72589248|NCT02120833|144709628|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.48|STANDARD_ERROR_OF_MEAN|3.54||0.0213|TWO_SIDED|95.0|1.33|15.63||The significance threshold level was 0.05 (two-sided).|ANCOVA|Treatment and study site as factors, baseline score as covariate.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||15.63|1.33|0.0213
72589249|NCT02120833|144709629|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||The significance level threshold level was 0.05 (two-sided).|One-sample t-test|Adjusted by study site.||The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline.||||<0.0001
72589250|NCT02120833|144709629|SUPERIORITY_OR_OTHER|||||||0.0172|TWO_SIDED|||||The significance level threshold level was 0.05 (two-sided).|One-sample t-test|Adjusted by study site.||The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline.||||0.0172
72589251|NCT02120833|144709629|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.56|STANDARD_ERROR_OF_MEAN|3.48||0.1968|TWO_SIDED|95.0|-2.46|11.58||The significance threshold level was 0.05 (two-sided).|ANCOVA|Treatment and study site as factors, baseline score as covariate.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||11.58|-2.46|0.1968
72589252|NCT02120833|144709630|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||The significance level threshold level was 0.05 (two-sided).|One-sample t-test|Adjusted by study site.||The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline.||||<0.0001
72589253|NCT02120833|144709630|SUPERIORITY_OR_OTHER|||||||0.0712|TWO_SIDED|||||The significance level threshold level was 0.05 (two-sided).|One-sample t-test|Adjusted by study site.||The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline.||||0.0712
72589254|NCT02120833|144709630|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.43|STANDARD_ERROR_OF_MEAN|3.34||0.0313|TWO_SIDED|95.0|0.7|14.15||The significance threshold level was 0.05 (two-sided).|ANCOVA|Treatment and study site as factors, baseline score as covariate.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||14.15|0.70|0.0313
72589255|NCT02438826|144709690|SUPERIORITY||LSMean Difference|-0.8||||0.334|TWO_SIDED|95.0|-2.77|1.17||Cui, Hung, Wang (CHW) procedure applied|Mixed Models Analysis|||||1.17|-2.77|0.334
72589256|NCT02438826|144709691|SUPERIORITY||Odds Ratio (OR)|1.297||||0.17|TWO_SIDED|95.0|0.83|2.028||Cui, Hung, Wang (CHW) procedure applied|Mixed Models Analysis|||||2.028|0.830|0.170
72589257|NCT02438826|144709692|SUPERIORITY|||||||0.946||||||Chui, Hung, Wang (CHW) procedure applied)|Mixed Models Analysis|||||||0.946
72589258|NCT02438826|144709693|SUPERIORITY||Odds Ratio (OR)|1.51||||0.057|TWO_SIDED|95.0|0.987|2.309|||Mixed Models Analysis|||||2.309|0.987|0.057
72589259|NCT02438826|144709694|SUPERIORITY||Odds Ratio (OR)|1.141||||0.713|TWO_SIDED|95.0|0.563|2.314|||Mixed Models Analysis|||||2.314|0.563|0.713
72589260|NCT02438826|144709695|SUPERIORITY||Odds Ratio (OR)|1.008||||0.979|TWO_SIDED|95.0|0.548|1.856|||Mixed Models Analysis|||||1.856|0.548|0.979
72589261|NCT02438826|144709696|SUPERIORITY||Odds Ratio (OR)|0.788||||0.437|TWO_SIDED|95.0|0.431|1.44|||Mixed Models Analysis|||||1.440|0.431|0.437
72589262|NCT02805179|144709708|SUPERIORITY|Compared to historical controls||||||0.03|||||||1-sided binomial test|||||||0.03
72589263|NCT00305084|144709720|OTHER||MDT|1.6|||||TWO_SIDED|||||||||All data regarding safety were registered and analyzed by descriptive analyses. Summary table were generated to document the safety|at least 3 patients per cohort had to be enrolled with expansion to 6 in presence of Dose Limiting Toxicity(DLT) (stop escalation if 2 or more DLTs at the same dose level). With a projection to achieve the highest level of NGR-hTNF, without significative toxicity (1.6 μg/m2) a planned sample of 20-25 patients was expected. DLTs were defined as: any severe toxicity clearly related to the administration of NGR-hTNF. The patient was defined assessable, according to the standard analysis, if he/she received at least one infusion of the investigational product. Maximal Tollerated Dose (MTD) was defined as the dose which produces DLTs in 2 or more patients out of 6 and will be recommended for phase II trials.|||
72414136|NCT05437510|144337243|SUPERIORITY||Efficacy|91.01||||0.006|TWO_SIDED|95.0|38.156|99.791|||Exact method using binomial distribution|||"Statistical analysis for UK:~The 2-sided 95% CI for the efficacy was calculated by an exact method assuming a binomial distribution of the number of very severe RSV LRTI through Day 151 post-dosing/randomization in the nirsevimab group conditional on the total number in both groups accounting for the follow-up time post-dosing/randomization."||99.791|38.156|0.0060
72589264|NCT00926848|144709757|SUPERIORITY||Mean Difference (Final Values)|4.0|||>|0.05|TWO_SIDED||||||t-test, 2 sided|||||||>.05
72589265|NCT00926848|144709758|SUPERIORITY||Mean Difference (Final Values)|6.6|||>|0.05|TWO_SIDED||||||t-test, 2 sided|||||||>.05
72589266|NCT00926848|144709759|SUPERIORITY||Mean Difference (Final Values)|0.3|||>|0.05|TWO_SIDED||||||t-test, 2 sided|||||||>.05
72589267|NCT00926848|144709760|SUPERIORITY||Mean Difference (Final Values)|0.6|||>|0.05|TWO_SIDED||||||t-test, 2 sided|||||||>.05
72589268|NCT00926848|144709761|SUPERIORITY||Mean Difference (Final Values)|0.3|||>|0.05|TWO_SIDED||||||t-test, 2 sided|||||||>.05
72589269|NCT00926848|144709762|SUPERIORITY||Mean Difference (Final Values)|0.8|||>|0.05|TWO_SIDED||||||t-test, 2 sided|||||||>.05
72589270|NCT01167881|144709763|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.46|STANDARD_ERROR_OF_MEAN|0.18|<|0.0001|TWO_SIDED|97.5|-4.87|-4.05||The superiority tests performed at 104 weeks and the superiority tests performed at 52 weeks both used a nominal significance level of 2.5% to maintain the overall significance level of 5%.|ANCOVA|ANCOVA with treatment, geographical region, renal function at baseline as fixed effects and baseline weight, baseline HbA1c as linear covariates.||"Testing Hierarchy for main analysis (104 weeks):~1. Non-inferiority in HbA1c change from baseline at 104 weeks,~2. Superiority in body weight change from baseline at 104 weeks,~3. Superiority in occurrence of confirmed hypoglycaemic adverse events at 104 weeks,~4. Superiority in HbA1c change from baseline at 104 weeks,~5. Superiority in systolic blood pressure change from baseline at 104 weeks,~6. Superiority in diastolic blood pressure change from baseline at 104 weeks."||-4.05|-4.87|<0.0001
72589271|NCT01167881|144709764|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was tested through a two-sided 97.5% confidence interval for the treatment effect of empagliflozin minus the effect of glimepiride in change from baseline in HbA1c. The null-hypothesis of material inferiority of empagliflozin was rejected if the confidence interval is entirely below the non-inferiority margin 0.3%.|Mean Difference (Net)|-0.11|STANDARD_ERROR_OF_MEAN|0.04|<|0.0001|TWO_SIDED|97.5|-0.2|-0.01|||ANCOVA|ANCOVA with treatment, geographical region, renal function at baseline as fixed effects and baseline HbA1c as linear covariate.||"Testing Hierarchy for main analysis (104 weeks):~1. Non-inferiority in HbA1c change from baseline at 104 weeks,~2. Superiority in body weight change from baseline at 104 weeks,~3. Superiority in occurrence of confirmed hypoglycaemic adverse events at 104 weeks,~4. Superiority in HbA1c change from baseline at 104 weeks,~5. Superiority in systolic blood pressure change from baseline at 104 weeks,~6. Superiority in diastolic blood pressure change from baseline at 104 weeks."||-0.01|-0.20|<0.0001
72589272|NCT01167881|144709764|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.11|STANDARD_ERROR_OF_MEAN|0.04||0.0153|TWO_SIDED|97.5|-0.2|-0.01||The superiority tests performed at 104 weeks and the superiority tests performed at 52 weeks both used a nominal significance level of 2.5% to maintain the overall significance level of 5%.|ANCOVA|ANCOVA with treatment, geographical region, renal function at baseline as fixed effects and baseline HbA1c as linear covariate.||"Testing Hierarchy for main analysis (104 weeks):~1. Non-inferiority in HbA1c change from baseline at 104 weeks,~2. Superiority in body weight change from baseline at 104 weeks,~3. Superiority in occurrence of confirmed hypoglycaemic adverse events at 104 weeks,~4. Superiority in HbA1c change from baseline at 104 weeks,~5. Superiority in systolic blood pressure change from baseline at 104 weeks,~6. Superiority in diastolic blood pressure change from baseline at 104 weeks."||-0.01|-0.20|0.0153
72589273|NCT01167881|144709765|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.102|||<|0.0001|TWO_SIDED|97.5|0.06|0.173||The superiority tests performed at 104 weeks and the superiority tests performed at 52 weeks both used a nominal significance level of 2.5% to maintain the overall significance level of 5%.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusting for baseline HbA1c (\<8.5 / \>=8.5).||"Testing Hierarchy for main analysis (104 weeks):~1. Non-inferiority in HbA1c change from baseline at 104 weeks,~2. Superiority in body weight change from baseline at 104 weeks,~3. Superiority in occurrence of confirmed hypoglycaemic adverse events at 104 weeks,~4. Superiority in HbA1c change from baseline at 104 weeks,~5. Superiority in systolic blood pressure change from baseline at 104 weeks,~6. Superiority in diastolic blood pressure change from baseline at 104 weeks."||0.173|0.060|<0.0001
72589274|NCT01167881|144709766|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.6|STANDARD_ERROR_OF_MEAN|0.6|<|0.0001|TWO_SIDED|97.5|-7.0|-4.2||The superiority tests performed at 104 weeks and the superiority tests performed at 52 weeks both used a nominal significance level of 2.5% to maintain the overall significance level of 5%.|ANCOVA|ANCOVA with treatment, geographical region, renal function at baseline as fixed effects and baseline SBP, baseline HbA1c as linear covariates.||"Testing Hierarchy for main analysis (104 weeks):~1. Non-inferiority in HbA1c change from baseline at 104 weeks,~2. Superiority in body weight change from baseline at 104 weeks,~3. Superiority in occurrence of confirmed hypoglycaemic adverse events at 104 weeks,~4. Superiority in HbA1c change from baseline at 104 weeks,~5. Superiority in systolic blood pressure change from baseline at 104 weeks,~6. Superiority in diastolic blood pressure change from baseline at 104 weeks."||-4.2|-7.0|<0.0001
72589275|NCT01167881|144709767|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.7|STANDARD_ERROR_OF_MEAN|0.4|<|0.0001|TWO_SIDED|97.5|-3.5|-1.8||The superiority tests performed at 104 weeks and the superiority tests performed at 52 weeks both used a nominal significance level of 2.5% to maintain the overall significance level of 5%.|ANCOVA|ANCOVA with treatment, geographical region, renal function at baseline as fixed effects and baseline DBP, baseline HbA1c as linear covariates.||"Testing Hierarchy for main analysis (104 weeks):~1. Non-inferiority in HbA1c change from baseline at 104 weeks,~2. Superiority in body weight change from baseline at 104 weeks,~3. Superiority in occurrence of confirmed hypoglycaemic adverse events at 104 weeks,~4. Superiority in HbA1c change from baseline at 104 weeks,~5. Superiority in systolic blood pressure change from baseline at 104 weeks,~6. Superiority in diastolic blood pressure change from baseline at 104 weeks."||-1.8|-3.5|<0.0001
72414137|NCT05437510|144337243|SUPERIORITY||Efficacy|26.01||||0.9851|TWO_SIDED|95.0|-337.329|89.162|||Exact method using binomial distribution|||"Statistical analysis for Germany:~The 2-sided 95% CI for the efficacy was calculated by an exact method assuming a binomial distribution of the number of very severe RSV LRTI through Day 151 post-dosing/randomization in the nirsevimab group conditional on the total number in both groups accounting for the follow-up time post-dosing/randomization."||89.162|-337.329|0.9851
72589276|NCT01167881|144709768|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was tested through a two-sided 97.5% confidence interval for the treatment effect of empagliflozin minus the effect of glimepiride in change from baseline in HbA1c. The null-hypothesis of material inferiority of empagliflozin was rejected if the confidence interval is entirely below the non-inferiority margin 0.3%.|Mean Difference (Net)|-0.07|STANDARD_ERROR_OF_MEAN|0.04|<|0.0001|TWO_SIDED|97.5|-0.16|0.02|||ANCOVA|ANCOVA with treatment, geographical region, renal function at baseline as fixed effects and baseline HbA1c as linear covariate.||"Testing Hierarchy for first interim analysis (52 weeks):~1. Non-inferiority in HbA1c change from baseline at 52 weeks,~2. Superiority in body weight change from baseline at 52 weeks,~3. Superiority in occurrence of confirmed hypoglycaemic adverse events at 52 weeks,~4. Superiority in systolic blood pressure change from baseline at 52 weeks,~5. Superiority in diastolic blood pressure change from baseline at 52 weeks."||0.02|-0.16|<0.0001
72589277|NCT01167881|144709769|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.81|STANDARD_ERROR_OF_MEAN|0.16|<|0.0001|TWO_SIDED|97.5|-5.16|-4.46||The superiority tests performed at 104 weeks and the superiority tests performed at 52 weeks both used a nominal significance level of 2.5% to maintain the overall significance level of 5%.|ANCOVA|ANCOVA with treatment, geographical region, renal function at baseline as fixed effects and baseline weight, baseline HbA1c as linear covariates.||"Testing Hierarchy for first interim analysis (52 weeks):~1. Non-inferiority in HbA1c change from baseline at 52 weeks,~2. Superiority in body weight change from baseline at 52 weeks,~3. Superiority in occurrence of confirmed hypoglycaemic adverse events at 52 weeks,~4. Superiority in systolic blood pressure change from baseline at 52 weeks,~5. Superiority in diastolic blood pressure change from baseline at 52 weeks."||-4.46|-5.16|<0.0001
72589278|NCT01167881|144709770|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.077|||<|0.0001|TWO_SIDED|97.5|0.04|0.148||The superiority tests performed at 104 weeks and the superiority tests performed at 52 weeks both used a nominal significance level of 2.5% to maintain the overall significance level of 5%.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusting for baseline HbA1c (\<8.5 / \>=8.5).||"Testing Hierarchy for first interim analysis (52 weeks):~1. Non-inferiority in HbA1c change from baseline at 52 weeks,~2. Superiority in body weight change from baseline at 52 weeks,~3. Superiority in occurrence of confirmed hypoglycaemic adverse events at 52 weeks,~4. Superiority in systolic blood pressure change from baseline at 52 weeks,~5. Superiority in diastolic blood pressure change from baseline at 52 weeks."||0.148|0.040|<0.0001
72589279|NCT01167881|144709771|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.8|STANDARD_ERROR_OF_MEAN|0.6|<|0.0001|TWO_SIDED|97.5|-7.3|-4.4||The superiority tests performed at 104 weeks and the superiority tests performed at 52 weeks both used a nominal significance level of 2.5% to maintain the overall significance level of 5%.|ANCOVA|ANCOVA with treatment, geographical region, renal function at baseline as fixed effects and baseline SBP, baseline HbA1c as linear covariates.||"Testing Hierarchy for first interim analysis (52 weeks):~1. Non-inferiority in HbA1c change from baseline at 52 weeks,~2. Superiority in body weight change from baseline at 52 weeks,~3. Superiority in occurrence of confirmed hypoglycaemic adverse events at 52 weeks,~4. Superiority in systolic blood pressure change from baseline at 52 weeks,~5. Superiority in diastolic blood pressure change from baseline at 52 weeks."||-4.4|-7.3|<0.0001
72589280|NCT01167881|144709772|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.8|STANDARD_ERROR_OF_MEAN|0.4|<|0.0001|TWO_SIDED|97.5|-3.7|-2.0||The superiority tests performed at 104 weeks and the superiority tests performed at 52 weeks both used a nominal significance level of 2.5% to maintain the overall significance level of 5%.|ANCOVA|ANCOVA with treatment, geographical region, renal function at baseline as fixed effects and baseline DBP, baseline HbA1c as linear covariates.||"Testing Hierarchy for first interim analysis (52 weeks):~1. Non-inferiority in HbA1c change from baseline at 52 weeks,~2. Superiority in body weight change from baseline at 52 weeks,~3. Superiority in occurrence of confirmed hypoglycaemic adverse events at 52 weeks,~4. Superiority in systolic blood pressure change from baseline at 52 weeks,~5. Superiority in diastolic blood pressure change from baseline at 52 weeks."||-2.0|-3.7|<0.0001
72589281|NCT01217476|144709853|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.36||||0.4039|TWO_SIDED|95.0|0.66|2.8|||Regression, Logistic|||||2.80|0.66|0.4039
72589282|NCT01217476|144709854|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.9|||||TWO_SIDED|95.0|0.52|1.56|||Regression, Logistic|||||1.56|0.52|
72589283|NCT04445714|144709861|SUPERIORITY||Mean Difference (Final Values)|-1.2|||<|0.0001|TWO_SIDED|95.0|-1.34|-1.03|||Paired t-test test|||Change from baseline||-1.03|-1.34|<.0001
72589284|NCT04445714|144709862|SUPERIORITY||Mean Difference (Final Values)|-2.1|||<|0.0001|TWO_SIDED|95.0|-2.66|-1.51|||Paired t-test test|||Change from baseline||-1.51|-2.66|<.0001
72589285|NCT04445714|144709863|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.8416|TWO_SIDED|95.0|-2.34|1.91|||Paired t-test test|||Change from baseline||1.91|-2.34|0.8416
72589286|NCT04445714|144709864|SUPERIORITY||Mean Difference (Final Values)|-24.4|||<|0.0001|TWO_SIDED|95.0|-33.4|-15.4|||Paired t-test test|||Change from baseline||-15.4|-33.4|<.0001
72589287|NCT04223635|144709871|OTHER|Least squares (LS) means were calculated from an analysis of variance (ANOVA) model on log-transformed scale. The LS means for each treatment were back transformed from the log scale to provide estimates of the geometric means (GMS). The ratio (%) of GMS was calculated and 90% Confidence Interval (CIs) for the ratio (%) of GMS were presented.|Ratio (%) of Geometric LS Mean|92.6|||||TWO_SIDED|90.0|54.38|157.69|||||For the comparison, moderate HI represents the numerator and normal HF represents the denominator.|||157.69|54.38|
72589288|NCT04223635|144709873|OTHER|Least squares means were calculated from an analysis of variance (ANOVA) model on log-transformed scale. The LS means for each treatment were back transformed from the log scale to provide estimates of the geometric means (GMS). The ratio (%) of GMS was calculated and 90% CIs for the ratio (%) of GMS were presented.|Ratio (%) of Geometric Least Square Mean|147.17|||||TWO_SIDED|90.0|95.39|227.07|||||For the comparison, moderate HI represents the numerator and normal HF represents the denominator.|||227.07|95.39|
72589289|NCT04223635|144709874|OTHER|Least squares means were calculated from an analysis of variance (ANOVA) model on log-transformed scale. The LS means for each treatment were back transformed from the log scale to provide estimates of the geometric means (GMS). The ratio (%) of GMS was calculated and 90% CIs for the ratio (%) of GMS were presented.|Ratio (%) of Geometric Least Square Mean|142.87|||||TWO_SIDED|90.0|91.21|223.79|||||For the comparison, moderate HI represents the numerator and normal HF represents the denominator.|||223.79|91.21|
72589290|NCT01729338|144709901|SUPERIORITY_OR_OTHER|||||||0.45||||||Compared baseline to 3 months|paired t-test|||||||0.45
72589291|NCT01729338|144709901|SUPERIORITY_OR_OTHER|||||||0.19|||||||paired t-test|compares baseline to month 5||||||0.19
72589292|NCT01729338|144709902|SUPERIORITY_OR_OTHER|||||||0.1||||||baseline, 3 month|paired t-test|||||||0.1
72589293|NCT01729338|144709902|SUPERIORITY_OR_OTHER|||||||0.09|||||||paired t-test|baseline, month 5||||||0.09
72589294|NCT03467217|144709909|SUPERIORITY||Mean Difference (Final Values)|1.1||||0.95|TWO_SIDED|95.0|-30.6|32.7|||ANCOVA|Adjusted for baseline value of ALT.||||32.7|-30.6|.95
72589295|NCT03467217|144709910|SUPERIORITY||Mean Difference (Final Values)|-2.5||||0.56|TWO_SIDED|95.0|-11.0|6.0|||ANCOVA|Adjusted for baseline value of GGT.||||6.0|-11.0|0.56
72589296|NCT03467217|144709911|SUPERIORITY||Mean Difference (Final Values)|4.7||||0.53|TWO_SIDED|95.0|-10.3|19.8|||ANCOVA|Adjusted for the baseline AST value.||||19.8|-10.3|0.53
72589297|NCT03467217|144709912|SUPERIORITY||Mean Difference (Final Values)|8.4||||0.57|TWO_SIDED|95.0|-20.8|37.5|||ANCOVA|Adjusted for the baseline ALT value.||||37.5|-20.8|0.57
72589298|NCT03467217|144709913|SUPERIORITY|Adjusted for the baseline ALT value.|Mean Difference (Final Values)|11.6||||0.25|TWO_SIDED|95.0|9.7|36.7|||ANCOVA|||||36.7|9.7|0.25
72589299|NCT03467217|144709914|SUPERIORITY||Mean Difference (Final Values)|3.4||||0.05|TWO_SIDED|95.0|0.0|6.8|||ANCOVA|Adjusted for the baseline HOMA-IR value.||||6.8|0.0|0.05
72589300|NCT03467217|144709915|SUPERIORITY||Mean Difference (Final Values)|0.5||||0.64|TWO_SIDED|95.0|-1.5|2.5|||ANCOVA|Adjusted for the baseline weight value.||||2.5|-1.5|0.64
72414138|NCT05437510|144337244|SUPERIORITY||Efficacy|43.62|||<|0.0001|TWO_SIDED|95.0|24.677|58.057|||Exact method using binomial distribution|||"Statistical analysis for Overall:~The 2-sided 95% CI for the efficacy was calculated by an exact method assuming a binomial distribution of the number of hospitalizations for all-cause LRTI through Day 151 post-dosing/randomization in the nirsevimab group conditional on the total number in both groups accounting for the follow-up time post-dosing/randomization."||58.057|24.677|<0.0001
72589301|NCT03467217|144709916|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.98|TWO_SIDED|95.0|-0.6|0.6|||ANCOVA|Adjusted for the baseline BMI value.||||0.6|-0.6|0.98
72589302|NCT03467217|144709917|SUPERIORITY||Mean Difference (Final Values)|2.4||||0.1|TWO_SIDED|95.0|-0.5|5.3|||ANCOVA|Adjusted for the baseline waist circumference value.||||5.3|-0.5|0.10
72589303|NCT03467217|144709918|SUPERIORITY||Mean Difference (Final Values)|0.02||||0.08|TWO_SIDED|95.0|0.0|0.05|||ANCOVA|Adjusted for the baseline waist-to-hip ratio.||||0.05|0.00|0.08
72589304|NCT03467217|144709919|SUPERIORITY||Mean Difference (Final Values)|3.1||||0.29|TWO_SIDED|95.0|-2.8|9.0|||ANCOVA|Adjusted for the baseline PedsQOL Physical Health score.||||9.0|-2.8|0.29
72589305|NCT03467217|144709920|SUPERIORITY|||||||0.17|||||||Exact conditional binomial test|||||||0.17
72589306|NCT03467217|144709921|SUPERIORITY||Mean Difference (Final Values)|-2.6||||0.64|TWO_SIDED|95.0|-13.9|8.7|||ANCOVA|Adjusted for baseline total cholesterol value.||||8.7|-13.9|0.64
72589307|NCT03467217|144709922|SUPERIORITY||Mean Difference (Final Values)|7.0||||0.67|TWO_SIDED|95.0|-25.6|39.7|||ANCOVA|Adjusted for baseline triglyceride value.||||39.7|-25.6|0.67
72589308|NCT03467217|144709923|SUPERIORITY||Mean Difference (Final Values)|-0.9||||0.45|TWO_SIDED|95.0|-3.4|1.5|||ANCOVA|Adjusted for baseline HDL cholesterol value.||||1.5|-3.4|0.45
72589309|NCT03467217|144709924|SUPERIORITY||Mean Difference (Final Values)|-0.4||||0.93|TWO_SIDED|95.0|-10.3|9.4|||ANCOVA|Adjusted for baseline LDL cholesterol value.||||9.4|-10.3|0.93
72589310|NCT03467217|144709925|SUPERIORITY||Median Difference (Final Values)|2.9||||0.29|TWO_SIDED|95.0|-2.5|20.1|||ANCOVA|Adjusted for baseline PedsQOL Psychosocial Health score.||||20.1|-2.5|0.29
72589311|NCT03233529|144709928|SUPERIORITY||Least Squares Mean Difference|-2.4|STANDARD_ERROR_OF_MEAN|0.35|<|0.0001|TWO_SIDED|95.0|-3.1|-1.7|||Mixed Models Analysis|||Crisaborole ointment 2% was superior to vehicle if p-value was \<0.05.||-1.7|-3.1|<0.0001
72589312|NCT03233529|144709929|SUPERIORITY||Least Squares Mean Difference|-0.9906|STANDARD_ERROR_OF_MEAN|0.48404||0.042|||||||Mixed Models Analysis|||Crisaborole ointment 2% was superior to vehicle if p-value was \<0.05.||||0.0420
72589313|NCT03233529|144709930|SUPERIORITY||Least Squares Mean Difference|-0.5446|STANDARD_ERROR_OF_MEAN|0.37855||0.1519|||||||Mixed Models Analysis|||Crisaborole ointment 2% was superior to vehicle if p-value was \<0.05.||||0.1519
72589314|NCT03233529|144709931|SUPERIORITY||Least Squares Mean Difference|-1.1273|STANDARD_ERROR_OF_MEAN|0.32552||0.0007|||||||Mixed Models Analysis|||Crisaborole ointment 2% was superior to vehicle if p-value was \<0.05.||||0.0007
72589315|NCT03233529|144709932|SUPERIORITY||Least Squares Mean Difference|-0.7612|STANDARD_ERROR_OF_MEAN|0.44266||0.0871|||||||Mixed Models Analysis|||Crisaborole ointment 2% was superior to vehicle if p-value was \<0.05.||||0.0871
72589316|NCT03233529|144709933|SUPERIORITY||Least Squares Mean Difference|-1.3641|STANDARD_ERROR_OF_MEAN|0.48603||0.0055|||||||Mixed Models Analysis|||Crisaborole ointment 2% was superior to vehicle if p-value was \<0.05.||||0.0055
72589317|NCT03233529|144709934|SUPERIORITY||Least Squares Mean Difference|-1.1246|STANDARD_ERROR_OF_MEAN|0.49359||0.0238|||||||Mixed Models Analysis|||Crisaborole ointment 2% was superior to vehicle if p-value was \<0.05.||||0.0238
72589318|NCT03233529|144709935|SUPERIORITY||Least Squares Mean Difference|-1.9913|STANDARD_ERROR_OF_MEAN|0.68659||0.0042|||||||Mixed Models Analysis|||Crisaborole ointment 2% was superior to vehicle if p-value was \<0.05.||||0.0042
72589319|NCT03233529|144709942|SUPERIORITY||Least Squares Mean Difference|-2.1|STANDARD_ERROR_OF_MEAN|0.33|<|0.0001|TWO_SIDED|95.0|-2.7|-1.4|||Mixed Models Analysis|||Crisaborole 2% was superior to vehicle if p-value was \<0.05.||-1.4|-2.7|< 0.0001
72589320|NCT03233529|144709943|SUPERIORITY||Least Square Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|0.17|<|0.0001|TWO_SIDED|95.0|-1.3|-0.6|||Mixed Models Analysis||Comparison at Day 8|Crisaborole ointment 2% was superior to vehicle if p-value was \<0.05.||-0.6|-1.3|< 0.0001
72589321|NCT03233529|144709943|SUPERIORITY||Least Squares Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|0.16|<|0.0001|TWO_SIDED|95.0|-1.4|-0.8|||Mixed Models Analysis||Comparison at Day 15|Crisaborole ointment 2% was superior to vehicle if p-value was \<0.05.||-0.8|-1.4|< 0.0001
72589322|NCT03233529|144709944|SUPERIORITY||Least Squares Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.36||0.0188|TWO_SIDED|95.0|-1.6|-0.1|||Mixed Models Analysis||Comparison at Day 2|Crisaborole ointment 2% was superior to vehicle if p-value was \<0.05.||-0.1|-1.6|0.0188
72589323|NCT03233529|144709944|SUPERIORITY||Least-Square Mean of Difference|-1.2|STANDARD_ERROR_OF_MEAN|0.36||0.0014|TWO_SIDED|95.0|-1.9|-0.4|||Mixed Models Analysis||Comparison at Day 3|Crisaborole ointment 2% was superior to vehicle if p-value was \<0.05.||-0.4|-1.9|0.0014
72589324|NCT03233529|144709944|SUPERIORITY||Least-Square Mean of Difference|-1.3|STANDARD_ERROR_OF_MEAN|0.36||0.0003|TWO_SIDED|95.0|-2.0|-0.6|||Mixed Models Analysis||Comparison at Day 4|Crisaborole ointment 2% was superior to vehicle if p-value was \<0.05.||-0.6|-2.0|0.0003
72589325|NCT03233529|144709944|SUPERIORITY||Least-Square Mean of Difference|-1.5|STANDARD_ERROR_OF_MEAN|0.36|<|0.0001|TWO_SIDED|95.0|-2.2|-0.8|||Mixed Models Analysis||Comparison at Day 5|Crisaborole ointment 2% was superior to vehicle if p-value was \<0.05.||-0.8|-2.2|< 0.0001
72589326|NCT03233529|144709944|SUPERIORITY||Least-Square Mean of Difference|-1.3|STANDARD_ERROR_OF_MEAN|0.36||0.0003|TWO_SIDED|95.0|-2.0|-0.6|||Mixed Models Analysis||Comparison at Day 6|Crisaborole ointment 2% was superior to vehicle if p-value was \<0.05.||-0.6|-2.0|0.0003
72589327|NCT03233529|144709944|SUPERIORITY||Least-Square Mean of Difference|-1.5|STANDARD_ERROR_OF_MEAN|0.36|<|0.0001|TWO_SIDED|95.0|-2.3|-0.8|||Mixed Models Analysis||Comparison at Day 7|Crisaborole ointment 2% was superior to vehicle if p-value was \<0.05.||-0.8|-2.3|< 0.0001
72589328|NCT03233529|144709944|SUPERIORITY||Least-Square Mean of Difference|-1.8|STANDARD_ERROR_OF_MEAN|0.36|<|0.0001|TWO_SIDED|95.0|-2.5|-1.1|||Mixed Models Analysis||Comparison at Day 8|Crisaborole ointment 2% was superior to vehicle if p-value was \<0.05.||-1.1|-2.5|< 0.0001
72589329|NCT03233529|144709944|SUPERIORITY||Least-Square Mean of Difference|-1.9|STANDARD_ERROR_OF_MEAN|0.36|<|0.0001|TWO_SIDED|95.0|-2.6|-1.2|||Mixed Models Analysis||Comparison at Day 9|Crisaborole ointment 2% was superior to vehicle if p-value was \<0.05.||-1.2|-2.6|< 0.0001
72589330|NCT03233529|144709944|SUPERIORITY||Least-Square Mean of Difference|-2.0|STANDARD_ERROR_OF_MEAN|0.36|<|0.0001|TWO_SIDED|95.0|-2.7|-1.3|||Mixed Models Analysis||Comparison at Day 10|Crisaborole ointment 2% was superior to vehicle if p-value was \<0.05.||-1.3|-2.7|< 0.0001
72589331|NCT03233529|144709944|SUPERIORITY||Least-Square Mean of Difference|-1.6|STANDARD_ERROR_OF_MEAN|0.37|<|0.0001|TWO_SIDED|95.0|-2.3|-0.9|||Mixed Models Analysis||Comparison at Day 11|Crisaborole ointment 2% was superior to vehicle if p-value was \<0.05.||-0.9|-2.3|< 0.0001
72589332|NCT03233529|144709944|SUPERIORITY||Least-Square Mean of Difference|-2.2|STANDARD_ERROR_OF_MEAN|0.36|<|0.0001|TWO_SIDED|95.0|-2.9|-1.5|||Mixed Models Analysis||Comparison at Day 12|Crisaborole ointment 2% was superior to vehicle if p-value was \<0.05.||-1.5|-2.9|< 0.0001
72589333|NCT03233529|144709944|SUPERIORITY||Least-Square Mean of Difference|-1.9|STANDARD_ERROR_OF_MEAN|0.36|<|0.0001|TWO_SIDED|95.0|-2.6|-1.2|||Mixed Models Analysis||Comparison at Day 13|Crisaborole ointment 2% was superior to vehicle if p-value was \<0.05.||-1.2|-2.6|< 0.0001
72589334|NCT03233529|144709944|SUPERIORITY||Least-Square Mean of Difference|-1.7|STANDARD_ERROR_OF_MEAN|0.36|<|0.0001|TWO_SIDED|95.0|-2.4|-1.0|||Mixed Models Analysis||Comparison at Day 14|Crisaborole ointment 2% was superior to vehicle if p-value was \<0.05.||-1.0|-2.4|< 0.0001
72589335|NCT03233529|144709944|SUPERIORITY||Least-Square Mean of Difference|-1.9|STANDARD_ERROR_OF_MEAN|0.36|<|0.0001|TWO_SIDED|95.0|-2.7|-1.2|||Mixed Models Analysis||Comparison at Day 15|Crisaborole ointment 2% was superior to vehicle if p-value was \<0.05.||-1.2|-2.7|< 0.0001
72589336|NCT01177293|144709947|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Natural log transformed AUC\[0- ∞\] of amlodipine was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.|Adjusted geometric means ratio|89.78|||||TWO_SIDED|90.0|82.74|97.43||||||A sample size of 12 completers provided 90% confidence intervals for the difference between treatment of +/-0.1155 on the natural log scale for AUCinf with 90% coverage probability. These calculations were based on estimates of within-participant standard deviations of 0.1234 for loge AUCinf.||97.43|82.74|
72589337|NCT01177293|144709948|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Natural log transformed AUClast of amlodipine was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.|Adjusted geometric mean ratio|99.73|||||TWO_SIDED|90.0|85.1|116.87||||||||116.87|85.10|
72589338|NCT01177293|144709949|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Natural log transformed Cmax of amlodipine was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.|Adjusted geometric means ratio|86.67|||||TWO_SIDED|90.0|79.57|94.42||||||A sample size of 12 completers provided 90% confidence intervals for the difference between treatment of +/-0.1278 on the natural log scale for Cmax with 90% coverage probability. These calculations were based on estimates of within-participant standard deviations of 0.1366 for loge Cmax.||94.42|79.57|
72589339|NCT01905553|144709963|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The magnitude effect of food on the pharmacokinetic parameters was evaluated by calculating the point estimate and 90% CIs between Treatment A (test treatment, fed) and Treatment B (reference treatment, fasted).|Ratio of Geometric LS Means|0.718|||||TWO_SIDED|90.0|0.67|0.77||||||||0.770|0.670|
72589340|NCT01905553|144709964|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The magnitude effect of food on the pharmacokinetic parameters was evaluated by calculating the point estimate and 90% CIs between Treatment A (test treatment, fed) and Treatment B (reference treatment, fasted).|Ratio of Geometric LS Means|0.718|||||TWO_SIDED|90.0|0.67|0.769||||||||0.769|0.670|
72589341|NCT01905553|144709965|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The magnitude effect of food on the pharmacokinetic parameters was evaluated by calculating the point estimate and 90% CIs between Treatment A (test treatment, fed) and Treatment B (reference treatment, fasted).|Ratio of Geometric LS Means|0.449|||||TWO_SIDED|90.0|0.38|0.53||||||||0.530|0.380|
72589342|NCT01767506|144709969|SUPERIORITY||Odds Ratio (OR)|2.6|||>|0.05|TWO_SIDED|95.0|0.56|11.9|||Regression, Logistic||||The null hypothesis was that we could further decrease infection to 1% or less in more of the communities in the surveillance intervention arm, compared to control communities.|11.9|0.56|>0.05
72589343|NCT01767506|144709970|SUPERIORITY||Mean Difference (Final Values)|3.9||||1|TWO_SIDED||||||Fisher Exact|||||||1
72589344|NCT03854370|144709988|SUPERIORITY|||||||0.23|||||||Chi-squared|||Comparison of all four groups prior to surgical scrub.||||0.23
72589345|NCT03854370|144709988|SUPERIORITY|||||||0.31|||||||Fisher Exact|||Comparison of baby shampoo versus iodine post surgical scrub||||0.31
72589346|NCT03854370|144709988|SUPERIORITY|||||||0.35|||||||Fisher Exact|||Comparison of Chlorhexidine versus iodine post surgical scrub||||.35
72589347|NCT03854370|144709988|SUPERIORITY|||||||0.61|||||||Fisher Exact|||Comparison of chloroxynel versus iodine post surgical scrub||||.61
72589348|NCT03854370|144709989|SUPERIORITY|||||||0.59|||||||Chi-squared|||comparison of all four groups prior to surgical scrub||||.59
72589349|NCT03854370|144709989|SUPERIORITY|||||||0.05|||||||Fisher Exact|||Comparison of baby shampoo versus iodine post surgical scrub||||.05
72589350|NCT03854370|144709989|SUPERIORITY|||||||0.13|||||||Fisher Exact|||Comparison of chlorhexidine versus iodine post surgical scrub||||.13
72589351|NCT03854370|144709989|SUPERIORITY|||||||0.99|||||||Fisher Exact|||Comparison of chloroxynel versus iodine at post surgical scrub||||0.99
72589352|NCT03854370|144709990|SUPERIORITY|||||||0.45|||||||Chi-squared|||Comparison of all four groups prior to surgical scrub||||0.45
72589353|NCT03854370|144709990|SUPERIORITY|||||||0.99||||||all groups were negative for cultures|Fisher Exact|||Comparison of baby shampoo versus iodine post surgical scrub||||0.99
72414139|NCT05437510|144337244|SUPERIORITY||Efficacy|34.78||||0.0754|TWO_SIDED|95.0|-4.148|59.648|||Exact method using binomial distribution|||"Statistical analysis for France:~The 2-sided 95% CI for the efficacy was calculated by an exact method assuming a binomial distribution of the number of hospitalizations for all-cause LRTI through Day 151 post-dosing/randomization in the nirsevimab group conditional on the total number in both groups accounting for the follow-up time post-dosing/randomization."||59.648|-4.148|0.0754
72589354|NCT03854370|144709990|SUPERIORITY|||||||0.99||||||All groups had negative cultures|Fisher Exact|||Comparison of chlorhexidine versus iodine at post surgical scrub||||0.99
72589355|NCT03854370|144709990|SUPERIORITY|||||||0.99||||||All groups had negative cultures|Fisher Exact|||Comparison of chloroxynel versus iodine at post surgical scrub||||0.99
72589356|NCT03854370|144709991|SUPERIORITY|||||||0.61|||||||Fisher Exact|||Comparison of baby shampoo versus iodine at post procedure||||0.61
72589357|NCT03854370|144709991|SUPERIORITY|||||||0.99|||||||Fisher Exact|||Comparison of chlorhexidine versus iodine at post procedure||||0.99
72589358|NCT03854370|144709991|SUPERIORITY|||||||0.99|||||||Fisher Exact|||Comparison of chloroxynel versus iodine at post procedure||||0.99
72589359|NCT03854370|144709992|SUPERIORITY|||||||0.32|||||||Fisher Exact|||Comparison of baby shampoo versus iodine at post procedure||||0.32
72589360|NCT03854370|144709992|SUPERIORITY|||||||0.99|||||||Fisher Exact|||Comparison of chlorhexidine versus iodine at post procedure||||0.99
72589361|NCT03854370|144709992|SUPERIORITY|||||||0.5|||||||Fisher Exact|||Comparison of chloroxynel versus iodine at post procedure||||0.50
72589362|NCT03854370|144709993|SUPERIORITY|||||||0.99||||||All groups had negative cultures|Fisher Exact|||Comparison of baby shampoo versus iodine at post procedure||||0.99
72589363|NCT03854370|144709993|SUPERIORITY|||||||0.99||||||All groups had negative cultures|Fisher Exact|||comparison of chlorhexidine versus iodine at post procedure||||0.99
72589364|NCT03854370|144709993|SUPERIORITY|||||||0.99||||||All groups had negative cultures|Fisher Exact|||Comparison of chloroxynel versus iodine at post procedure||||0.99
72589365|NCT01608087|144710026|EQUIVALENCE|Commonly applied acceptance range for bioequivalence/biosimilarity is 80% to 125%.|gMean ratio|96.58|||||TWO_SIDED|93.93|88.54|105.35|||ANOVA|Analysis of variance (ANOVA) model on the logarithmic scale including effects'treatment' and 'weight'.|(T/R1) \* 100||Least squares estimates of log-transformed PK endpoint for T and R1 were back transformed to original scale to get adjusted point estimator and interval estimates for the ratio of the geometric means for treatments.|105.35|88.54|
72589366|NCT01608087|144710026|EQUIVALENCE|Commonly applied acceptance range for bioequivalence/biosimilarity is 80% to 125%.|gMean ratio|91.68|||||TWO_SIDED|93.93|83.5|100.65|||ANOVA|Analysis of variance (ANOVA) model on the logarithmic scale including effects'treatment' and 'weight'.|(T/R2) \* 100||Least squares estimates of log-transformed PK endpoint for T and R1 were back transformed to original scale to get adjusted point estimator and interval estimates for the ratio of the geometric means for treatments.|100.65|83.50|
72589367|NCT01608087|144710026|EQUIVALENCE|Commonly applied acceptance range for bioequivalence/biosimilarity is 80% to 125%.|gMean ratio|94.92|||||TWO_SIDED|93.93|87.14|103.4|||ANOVA|Analysis of variance (ANOVA) model on the logarithmic scale including effects'treatment' and 'weight'.|(R1/R2) \* 100||Least squares estimates of log-transformed PK endpoint for T and R1 were back transformed to original scale to get adjusted point estimator and interval estimates for the ratio of the geometric means for treatments.|103.40|87.14|
72589368|NCT01608087|144710027|EQUIVALENCE|Commonly applied acceptance range for bioequivalence/biosimilarity is 80% to 125%.|gMean ratio|98.96|||||TWO_SIDED|90.0|90.97|107.64|||ANOVA|Analysis of variance (ANOVA) model on the logarithmic scale including effects'treatment' and 'weight'.|(T/R1) \* 100||Least squares estimates of log-transformed PK endpoint for T and R1 were back transformed to original scale to get adjusted point estimator and interval estimates for the ratio of the geometric means for treatments.|107.64|90.97|
72589369|NCT01608087|144710027|EQUIVALENCE|Commonly applied acceptance range for bioequivalence/biosimilarity is 80% to 125%.|gMean ratio|91.67|||||TWO_SIDED|90.0|84.02|100.01|||ANOVA|Analysis of variance (ANOVA) model on the logarithmic scale including effects'treatment' and 'weight'.|(T/R2) \* 100||Least squares estimates of log-transformed PK endpoint for T and R1 were back transformed to original scale to get adjusted point estimator and interval estimates for the ratio of the geometric means for treatments.|100.01|84.02|
72589370|NCT01608087|144710027|EQUIVALENCE|Commonly applied acceptance range for bioequivalence/biosimilarity is 80% to 125%.|gMean ratio|92.63|||||TWO_SIDED|90.0|85.18|100.74|||ANOVA|Analysis of variance (ANOVA) model on the logarithmic scale including effects'treatment' and 'weight'.|(R1/R2) \* 100||Least squares estimates of log-transformed PK endpoint for T and R1 were back transformed to original scale to get adjusted point estimator and interval estimates for the ratio of the geometric means for treatments.|100.74|85.18|
72589371|NCT01608087|144710028|EQUIVALENCE|Commonly applied acceptance range for bioequivalence/biosimilarity is 80% to 125%.|gMean ratio|101.53|||||TWO_SIDED|90.0|92.74|111.14|||ANOVA|Analysis of variance (ANOVA) model on the logarithmic scale including effects'treatment' and 'weight'.|(T/R1) \* 100||Least squares estimates of log-transformed PK endpoint for T and R1 were back transformed to original scale to get adjusted point estimator and interval estimates for the ratio of the geometric means for treatments.|111.14|92.74|
72589372|NCT01608087|144710028|EQUIVALENCE|Commonly applied acceptance range for bioequivalence/biosimilarity is 80% to 125%.|gMean ratio|93.25|||||TWO_SIDED|90.0|87.12|99.81|||ANOVA|Analysis of variance (ANOVA) model on the logarithmic scale including effects'treatment' and 'weight'.|(T/R2) \* 100||Least squares estimates of log-transformed PK endpoint for T and R1 were back transformed to original scale to get adjusted point estimator and interval estimates for the ratio of the geometric means for treatments.|99.81|87.12|
72589373|NCT01608087|144710028|EQUIVALENCE|Commonly applied acceptance range for bioequivalence/biosimilarity is 80% to 125%.|gMean ratio|91.85|||||TWO_SIDED|90.0|83.91|100.54|||ANOVA|Analysis of variance (ANOVA) model on the logarithmic scale including effects'treatment' and 'weight'.|(R1/R2) \* 100||Least square estimates of log-transformed PK endpoint for R1 and R2 were back transformed to original scale to get adjusted point estimator and interval estimates for the inter-subject ratio of the geometric means for treatments.|100.54|83.91|
72589374|NCT01011465|144710044|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.4||||0.03||95.0|||||t-test, 2 sided|||The null hypothesis is that both groups will have similar rise in SBP in response to stress.||||0.03
72589375|NCT01011465|144710044|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.23||||0.89||95.0|||||t-test, 2 sided|||The null hypothesis is that both groups will have similar rise in SBP in response to stress.||||0.89
72589376|NCT01011465|144710044|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.01||||0.52||95.0|||||t-test, 2 sided|||The null hypothesis is that both groups will have similar rise in SBP in response to stress.||||0.52
72589377|NCT01011465|144710045|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.42||||0.43||95.0|||||t-test, 2 sided|||The null hypothesis states that both groups will have similar PANAS negative affect score change in response to stress.||||0.43
72589378|NCT01011465|144710045|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.96||||0.08||95.0|||||t-test, 2 sided|||The null hypothesis states that both groups will have similar PANAS negative affect score change in response to stress.||||0.08
72589379|NCT01011465|144710045|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.64||||0.25||95.0|||||ANOVA|||The null hypothesis states that both groups will have similar PANAS negative affect score change in response to stress.||||0.25
72589380|NCT01011465|144710046|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.03||||0.83||95.0|||||t-test, 2 sided|||The null hypothesis states that both groups had similar threat/challenge scores during the speech task.||||0.83
72589381|NCT01011465|144710046|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.08||||0.56||95.0|||||t-test, 2 sided|||The null hypothesis states that both groups had similar threat/challenge scores during the speech task.||||0.56
72589382|NCT01011465|144710046|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01||||0.95||95.0|||||t-test, 2 sided|||The null hypothesis states that both groups had similar threat/challenge scores during the speech task.||||0.95
72589383|NCT01683266|144710142|NON_INFERIORITY_OR_EQUIVALENCE|"Stepwise closed testing approach was used to assess non-inferiority and superiority sequentially:~1. Non-inferiority of HOE901-U300 vs Lantus: Upper bound of two-sided 95% confidence interval (CI) of difference between HOE901-U300 and Lantus on mITT population is \<0.4%.~2. Superiority (only if non-inferiority has been demonstrated): Upper bound of two-sided 95% CI for difference in mean change in HbA1c from baseline to endpoint between HOE901-U300 and Lantus on mITT population is \<0."|Least Squares (LS) Mean difference|0.04|STANDARD_ERROR_OF_MEAN|0.072|||TWO_SIDED|95.0|-0.098|0.185||||||Analysis was performed using mixed model for repeated measurements (MMRM) with treatment groups, strata of screening HbA1c (\<8.0, \>=8.0%), geographical region (Non-Japan; Japan), visit and visit-by-treatment groups interaction as fixed categorical effects; baseline HbA1c and baseline HbA1c-by-visit interaction as continuous fixed covariates.||0.185|-0.098|
72589384|NCT01683266|144710145|SUPERIORITY_OR_OTHER||LS Mean difference|-0.35|STANDARD_ERROR_OF_MEAN|0.322|||TWO_SIDED|95.0|-0.982|0.287||||||Change in pre-injection SMPG was analyzed using MMRM model with treatment groups, strata of screening HbA1c (\<8.0, \>=8.0%), geographical region (Non-Japan; Japan), visit and visit-by-treatment groups interaction as fixed categorical effects; pre-injection SMPG value and pre-injection SMPG value-by-visit interaction as continuous fixed covariates.||0.287|-0.982|
72589385|NCT01062113|144710210|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|38.2|STANDARD_ERROR_OF_MEAN|9.1|<|0.0001|TWO_SIDED|95.0|20.3|56.1||The difference in the efficacy rates was tested using normal distribution at a significance level of 2-sided 5%. 2-sided 95% confidence interval (CI) for the difference in the efficacy rates was calculated using normal approximation.|asymptotic z-test|||||56.1|20.3|<0.0001
72589386|NCT01062113|144710212|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0003||95.0|||||t-test, 2 sided|||||||0.0003
72589387|NCT01062113|144710213|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||t-test, 2 sided|||||||<0.0001
72589388|NCT01471340|144710214|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The projected sample size provided 90% power at a 2.5% alpha level (one-sided) to determine non-inferiority of MF/F and MF. For analysis of the first SAO in participants, MF/F MDI BID was considered non-inferior to MF MDI BID if the upper bound for the 95% confidence interval (CI) of the hazard ratio (HR) of MF/F MDI BID versus MF MDI BID was lower than 2.0 (noninferiority margin).|Hazard Ratio (HR)|1.22||||0.411|TWO_SIDED|95.0|0.76|1.94|||Cox proportional-hazard model||The HR and 95% CI were based on the Cox proportional-hazard model with covariates of treatment (MF/F or MF) and ICS dose level (200 or 400 mcg).|Pertains only to the First SAO; pooled MF/F treatments and pooled MF treatments||1.94|0.76|0.411
72589389|NCT01471340|144710215|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.89||||0.021|TWO_SIDED|95.0|0.8|0.98|||Cox proportional-hazard model|Superiority of MF/F MDI BID vs MF MDI BID was determined if the HR was less than 1 and achieved statistical significance (one-sided p-value \< 0.025).|The HR and 95% CI were based on the Cox proportional-hazard model with covariates of treatment (MF/F or MF) and ICS dose level (200 or 400 mcg).|Pertains only to the First SAEX; pooled MF/F treatments and pooled MF treatments||0.98|0.80|0.021
72589390|NCT00526669|144710220|SUPERIORITY_OR_OTHER|||||||0.1||95.0||||Biomarker: TS|Wilcoxon signed rank test|||||||0.10
72589391|NCT00526669|144710220|SUPERIORITY_OR_OTHER|||||||0.097||95.0||||Biomarker: DPD|Wilcoxon signed rank test|||||||0.097
72589392|NCT00526669|144710220|SUPERIORITY_OR_OTHER|||||||0.1||95.0||||Biomarker: EGFR/HER1|Wilcoxon signed rank test|||||||0.10
72589393|NCT00526669|144710220|SUPERIORITY_OR_OTHER|||||||0.26||95.0||||Biomarker: HER2|Wilcoxon signed rank test|||||||0.26
72589394|NCT00526669|144710220|SUPERIORITY_OR_OTHER|||||||0.38||95.0||||Biomarker: HER3|Wilcoxon signed rank test|||||||0.38
72589395|NCT00526669|144710221|SUPERIORITY_OR_OTHER||percentage of participants|17.9|||||TWO_SIDED|95.0|9.6|29.2|||||The estimated value represents the percentage of participants with complete response or partial response.|||29.2|9.6|
72589396|NCT00526669|144710222|SUPERIORITY_OR_OTHER||percentage of participants|29.0|||||TWO_SIDED|95.0|17.9|40.3|||||The estimated value reflects the percentage of participants who achieved progression-free survival.|||40.3|17.9|
72589397|NCT04259424|144710246|OTHER|||||||0.15|||||||t-test, 2 sided|||||||.15
72589398|NCT01082211|144710294|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0002|||||||Chi-squared|||Assuming a 3-year rate of 25% using a chi-squared test, a sample size of 55 patients will ensure at least 90% probability of detecting a reduction in the 3-year ipsilateral in-breast recurrence rate from 25% to 9%, with a significance level of 0.05 (1-sided). In-breast recurrence will be estimated using the cumulative incidence method.||||0.0002
72589399|NCT01082211|144710302|OTHER||Effect size|0.1|||||TWO_SIDED||||||||Effect sizes are interpreted as negligible: \< 0.3; small: 0.3 to \< 0.5; moderate: 0.5 to \< 0.7; and large ≥ 0.7|Functional status||||
72589400|NCT01082211|144710302|OTHER||Effect size|0.14|||||TWO_SIDED||||||||Effect sizes are interpreted as negligible: \< 0.3; small: 0.3 to \< 0.5; moderate: 0.5 to \< 0.7; and large ≥ 0.7|Cosmetic||||
72589401|NCT01082211|144710302|OTHER||Effect size|0.34|||||TWO_SIDED||||||||Effect sizes are interpreted as negligible: \< 0.3; small: 0.3 to \< 0.5; moderate: 0.5 to \< 0.7; and large ≥ 0.7|Breast-specific pain||||
72589402|NCT01082211|144710303|OTHER||Effect size|0.04|||||TWO_SIDED||||||||Effect sizes are interpreted as negligible: \< 0.3; small: 0.3 to \< 0.5; moderate: 0.5 to \< 0.7; and large ≥ 0.7|Functional status||||
72589403|NCT01082211|144710303|OTHER||Effect size|0.32|||||TWO_SIDED||||||||Effect sizes are interpreted as negligible: \< 0.3; small: 0.3 to \< 0.5; moderate: 0.5 to \< 0.7; and large ≥ 0.7|Cosmetic||||
72589404|NCT01082211|144710303|OTHER||Effect size|0.28|||||TWO_SIDED||||||||Effect sizes are interpreted as negligible: \< 0.3; small: 0.3 to \< 0.5; moderate: 0.5 to \< 0.7; and large ≥ 0.7|Breast-specific pain||||
72589405|NCT01082211|144710305|OTHER|||||||0.054|||||||Spearman rank-order correlation test|||||||0.054
72589406|NCT01082211|144710305|OTHER|||||||0.044|||||||Spearman rank-order correlation test|||||||0.044
72589407|NCT01082211|144710305|OTHER|||||||0.087|||||||Spearman rank-order correlation test|||||||0.087
72589408|NCT03702010|144710311|SUPERIORITY|||||||0.112|||||||t-test, 2 sided|||Baseline VAS||||0.112
72589409|NCT03702010|144710311|SUPERIORITY|||||||0.323|||||||t-test, 2 sided|||After first stimulation VAS||||0.323
72589410|NCT03702010|144710311|SUPERIORITY|||||||0.76|||||||t-test, 2 sided|||After second stimulation||||0.760
72589411|NCT03702010|144710311|SUPERIORITY|||||||0.624|||||||t-test, 2 sided|||End of Follow-up||||0.624
72589412|NCT03702010|144710312|SUPERIORITY|||||||0.589|||||||t-test, 2 sided|||After first stimulation||||0.589
72589413|NCT03702010|144710312|SUPERIORITY|||||||0.704|||||||t-test, 2 sided|||After second stimulation||||0.704
72589414|NCT03702010|144710312|SUPERIORITY|||||||0.908|||||||t-test, 2 sided|||End of Follow-up||||0.908
72589415|NCT03702010|144710313|SUPERIORITY|||||||0.231|||||||t-test, 2 sided|||Baseline||||0.231
72589416|NCT03702010|144710313|SUPERIORITY|||||||0.663|||||||t-test, 2 sided|||After first stimulation||||0.663
72589417|NCT03702010|144710313|SUPERIORITY|||||||0.998|||||||t-test, 2 sided|||After second stimulation||||0.998
72589418|NCT03702010|144710313|SUPERIORITY|||||||0.713|||||||t-test, 2 sided|||End of Follow-up||||0.713
72589419|NCT01080118|144710355|SUPERIORITY_OR_OTHER||Odds Ratio, log|0.05||||0.001|TWO_SIDED|99.0|0.05|0.05|||t-test, 2 sided|||||.05|.05|.001
72589420|NCT01080118|144710355|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence||||||0.001||95.0|||||t-test, 2 sided|||||||.001
72589421|NCT01146379|144710357|SUPERIORITY_OR_OTHER|||||||0.01||||||a prior threshold for statistical significance = 0.05. P value was not corrected for multiple comparisons|Mixed Models Analysis|||The primary analysis used hierarchical linear modeling to examine the rate of change in ARAT over time. The null hypothesis was that all groups would change at a similar rate.||||.01
72589422|NCT01146379|144710357|SUPERIORITY_OR_OTHER|||||||0.036|||||||t-test, 2 sided|||This analysis then asked which groups were different from the Low Movement Dose group||||.036
72589423|NCT01146379|144710357|SUPERIORITY_OR_OTHER|||||||0.679|||||||t-test, 2 sided|||This analysis asked if the Low Movement Dose group was different from the High Movement Dose group||||0.679
72589424|NCT01146379|144710357|SUPERIORITY_OR_OTHER|||||||0.209|||||||t-test, 2 sided|||This analysis tested if the Low Movement Dose group was different from the Individual Maximum High Movement Dose group||||0.209
72589425|NCT02004886|144710361|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-25.9|||<|0.001|TWO_SIDED|95.0|-38.4|-13.3|||ANCOVA|Terms for treatment, prior AHA therapy status, and baseline 24-hour WMG value as a covariate.||||-13.3|-38.4|<0.001
72589426|NCT02004886|144710361|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-53.6|||<|0.001|TWO_SIDED|95.0|-66.1|-41.1|||ANCOVA|Terms for treatment, prior AHA therapy status, and baseline 24-hour WMG value as a covariate.||||-41.1|-66.1|<0.001
72589427|NCT02004886|144710361|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-26.0|||<|0.001|TWO_SIDED|95.0|-38.4|-13.6|||ANCOVA|Terms for treatment, prior AHA therapy status, and baseline 24-hour WMG value as a covariate.||||-13.6|-38.4|<0.001
72589428|NCT02004886|144710364|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-18.3||||0.04|TWO_SIDED|95.0|-35.7|-0.9|||ANCOVA|Relevant baseline efficacy measurements were the covariates.||||-0.9|-35.7|0.04
72589429|NCT02004886|144710364|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-43.6|||<|0.001|TWO_SIDED|95.0|-60.9|-26.3|||ANCOVA|Relevant baseline efficacy measurements were the covariates.||||-26.3|-60.9|<0.001
72589430|NCT02004886|144710364|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.6||||0.32|TWO_SIDED|95.0|-25.7|8.5|||ANCOVA|Relevant baseline efficacy measurements were the covariates.||||8.5|-25.7|0.320
72589431|NCT02004886|144710366|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||0.751|TWO_SIDED|95.0|-0.7|0.9|||ANCOVA|||||0.9|-0.7|0.751
72589432|NCT02004886|144710366|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2||||0.581|TWO_SIDED|95.0|-1.0|0.6|||ANCOVA|||||0.6|-1.0|0.581
72589433|NCT02004886|144710366|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.918|TWO_SIDED|95.0|-0.8|0.8|||ANCOVA|||||0.8|-0.8|0.918
72589434|NCT02004886|144710368|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.7||||0.253|TWO_SIDED|95.0|-21.1|5.6|||ANCOVA|||||5.6|-21.1|0.253
72414140|NCT05437510|144337244|SUPERIORITY||Efficacy|40.67||||0.0177|TWO_SIDED|95.0|8.211|62.156|||Exact method using binomial distribution|||"Statistical analysis for UK:~The 2-sided 95% CI for the efficacy was calculated by an exact method assuming a binomial distribution of the number of hospitalizations for all-cause LRTI through Day 151 post-dosing/randomization in the nirsevimab group conditional on the total number in both groups accounting for the follow-up time post-dosing/randomization."||62.156|8.211|0.0177
72589435|NCT02004886|144710368|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.5||||0.07|TWO_SIDED|95.0|-26.0|1.0|||ANCOVA|||||1.0|-26.0|0.070
72589436|NCT02004886|144710368|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-26.1|||<|0.001|TWO_SIDED|95.0|-39.5|-12.8|||ANCOVA|||||-12.8|-39.5|<0.001
72589437|NCT02004886|144710369|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-89.9||||0.002|TWO_SIDED|95.0|-145.6|-34.0|||ANCOVA|Relevant baseline efficacy measurements were the covariates.||||-34.0|-145.6|0.002
72589438|NCT02004886|144710369|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-191.1|||<|0.001|TWO_SIDED|95.0|-246.4|-135.9|||ANCOVA|Relevant baseline efficacy measurements were the covariates.||||-135.9|-246.4|<0.001
72589439|NCT02004886|144710369|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-97.7||||0.001|TWO_SIDED|95.0|-152.4|-42.9|||ANCOVA|Relevant baseline efficacy measurements were the covariates.||||-42.9|-152.4|0.001
72589440|NCT02004886|144710370|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.1||||0.408|TWO_SIDED|95.0|-1.5|3.7|||ANCOVA|||||3.7|-1.5|0.408
72589441|NCT02004886|144710370|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4||||0.741|TWO_SIDED|95.0|-3.1|2.2|||ANCOVA|||||2.2|-3.1|0.741
72589442|NCT02004886|144710370|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2||||0.906|TWO_SIDED|95.0|-2.8|2.5|||ANCOVA|||||2.5|-2.8|0.906
72589443|NCT02004886|144710371|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.5||||0.857|TWO_SIDED|95.0|-30.4|25.3|||ANCOVA|||||25.3|-30.4|0.857
72589444|NCT02004886|144710371|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.7||||0.906|TWO_SIDED|95.0|-30.3|26.9|||ANCOVA|||||26.9|-30.3|0.906
72589445|NCT02004886|144710371|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.6||||0.63|TWO_SIDED|95.0|-34.0|20.8|||ANCOVA|||||20.8|-34.0|0.630
72589446|NCT01876784|144710372|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.75||||0.08|TWO_SIDED|95.0|0.55|1.03||Threshold for significance at 0.05 level.|Log Rank||Vandetanib 300 mg vs Placebo|A multiple testing procedure (MTP) with an alpha-exhaustive recycling strategy was employed to provide adequate control of type I error.||1.03|0.55|0.080
72589447|NCT03605862|144710379|SUPERIORITY|||||||0.4009|||||||Gehan-Wilcoxon|Analysis was stratified by time from onset of symptoms, pre-enrollment symptom relief medication use, and presence of underlying lung conditions||||||0.4009
72589448|NCT03605862|144710380|SUPERIORITY|||||||0.1923|||||||Gehan-Wilcoxon|Analysis was stratified by time from onset of symptoms, pre-enrollment symptom relief medication use, and presence of underlying lung conditions||||||0.1923
72589449|NCT03605862|144710381|SUPERIORITY|||||||0.2057|||||||Fisher Exact|||||||0.2057
72589450|NCT03605862|144710382|SUPERIORITY|||||||0.0712|||||||Gehan-Wilcoxon|Analysis stratified by time from symptom onset at Baseline, pre-enrollment symptom relief medication use, and presence of underlying lung condition||||||0.0712
72589451|NCT03605862|144710383|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison for study day 2||||1.0000
72589452|NCT03605862|144710383|SUPERIORITY|||||||0.9142|||||||Fisher Exact|||Comparison for study day 3||||0.9142
72589453|NCT03605862|144710383|SUPERIORITY|||||||0.0132|||||||Fisher Exact|||Comparison for study day 7||||0.0132
72589454|NCT03605862|144710384|SUPERIORITY|||||||0.1239|||||||t-test, 2 sided|||Comparison for day 2||||0.1239
72589455|NCT03605862|144710384|SUPERIORITY|||||||0.1022|||||||t-test, 2 sided|||Comparison for day 3||||0.1022
72589456|NCT03605862|144710384|SUPERIORITY|||||||0.46213|||||||t-test, 2 sided|||Comparison for day 7||||0.46213
72589457|NCT03605862|144710387|SUPERIORITY|||||||0.014|||||||Gehan-Wilcoxon|Analysis stratified by time from symptom onset at first dose, pre-enrollment symptom relief medication use, and presence of underlying lung condition||||||0.0140
72589458|NCT03605862|144710388|SUPERIORITY|||||||0.0112|||||||Gehan-Wilcoxon|Analysis stratified by time from onset at first dose, pre-enrollment symptom relief medication use, and presence of underlying lung condition||||||0.0112
72589459|NCT03605862|144710389|SUPERIORITY||||||<|0.0001|||||||Gehan-Wilcoxon|Analysis stratified by time from onset at first dose, pre-enrollment symptom relief medication use, and presence of underlying lung condition||||||<0.0001
72589460|NCT05239494|144710390|SUPERIORITY||Median Difference (Final Values)|0.001|||<|0.001|TWO_SIDED||||||Shapiro-Wilks|||This study used a ±50 VAS scale, with values in the positive and negative range indicating that the contact lenses were comfortable or uncomfortable, respectively. A score of zero on this scale indicated neutral CL comfort.||||<0.001
72589461|NCT02235077|144710431|SUPERIORITY||Mean Difference (Final Values)|0.05||||0.5688|TWO_SIDED|95.0|-0.11|0.2|||Regression, Linear|||||0.20|-0.11|0.5688
72589462|NCT02235077|144710432|SUPERIORITY||Mean Difference (Final Values)|0.25||||0.4155|TWO_SIDED|95.0|-0.35|0.86|||Regression, Linear|||||0.86|-0.35|0.4155
72589463|NCT02235077|144710433|SUPERIORITY||Odds Ratio (OR)|1.23||||0.3039|TWO_SIDED|95.0|0.83|1.81|||Chi-squared|||||1.81|0.83|0.3039
72589464|NCT02235077|144710434|SUPERIORITY||Mean Difference (Final Values)|-0.01||||0.7673|TWO_SIDED|95.0|-0.09|0.07|||Regression, Linear|||||0.07|-0.09|0.7673
72589465|NCT02235077|144710435|SUPERIORITY||Mean Difference (Final Values)|319.2||||0.5734|TWO_SIDED|95.0|-797.4|1435.8|||Regression, Linear|||||1435.8|-797.4|0.5734
72589466|NCT02235077|144710436|SUPERIORITY||Mean Difference (Final Values)|-1.02||||0.3528|TWO_SIDED|95.0|-3.05|1.01|||Regression, Linear|||||1.01|-3.05|0.3528
72589467|NCT02235077|144710437|SUPERIORITY||Mean Difference (Final Values)|0.11||||0.0846|TWO_SIDED|95.0|-0.02|0.25|||Regression, Linear|||||0.25|-0.02|0.0846
72589468|NCT02235077|144710438|SUPERIORITY||Mean Difference (Final Values)|-12.17||||0.0842|TWO_SIDED|95.0|-25.98|1.65|||Regression, Linear|||||1.65|-25.98|0.0842
72589469|NCT02235077|144710439|SUPERIORITY||Odds Ratio (OR)|1.11||||0.7628|TWO_SIDED|95.0|0.56|2.23|||Regression, Logistic|||||2.23|0.56|0.7628
72589470|NCT02235077|144710440|SUPERIORITY||Mean Difference (Final Values)|-1.04||||0.6102|TWO_SIDED|95.0|-5.02|2.95|||Regression, Linear|||||2.95|-5.02|0.6102
72589471|NCT02235077|144710441|SUPERIORITY||Odds Ratio (OR)|0.76||||0.5818|TWO_SIDED|95.0|0.29|1.99|||Regression, Logistic|||||1.99|0.29|0.5818
72589472|NCT00586820|144710445|SUPERIORITY_OR_OTHER|||||||0.029|||||||t-test, 2 sided|||||||0.029
72589473|NCT00586820|144710446|SUPERIORITY_OR_OTHER|||||||0.019|||||||t-test, 2 sided|||Change between the groups from immediate pre-PCI and 8 hours post PCI.||||0.019
72589474|NCT00586820|144710446|SUPERIORITY_OR_OTHER|||||||0.007|||||||t-test, 2 sided|||Change between the groups from immediate pre-PCI and 16 hours post-PCI.||||0.007
72589475|NCT02122887|144710490|OTHER|χ² (1) =4.57, Cramer's V=.24|||||<|0.05|||||||Chi-squared|||we hypothesised that following intervention, those undergoing intervention will be more likely to see justice on both sides, compared to control group||||<0.05
72589476|NCT02122887|144710491|EQUIVALENCE|we compared participants levels of tension (in their interaction with an outgroup member in trail 2) in an interaction test between perspective-taking levels and group|Mean Difference (Final Values)|0.65|||>|0.05|TWO_SIDED|95.0|||||ANOVA|df=1||||||>0.05
72589477|NCT02122887|144710492|EQUIVALENCE|we compared participants levels of empathy (in their interaction with an outgroup member in trail 2) in an interaction test between perspective-taking levels and group|Mean Difference (Final Values)|0.04|||>|0.05|TWO_SIDED|95.0|||||ANOVA|||||||>0.05
72589478|NCT00972816|144710496|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 22|3.998|||||TWO_SIDED|95.0|2.659|6.009||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||6.009|2.659|
72589479|NCT00972816|144710496|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 22|1.222|||||TWO_SIDED|95.0|0.813|1.838||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||1.838|0.813|
72589480|NCT00972816|144710496|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 22|0.661|||||TWO_SIDED|95.0|0.44|0.994||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||0.994|0.440|
72589481|NCT00972816|144710496|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 22|2.178|||||TWO_SIDED|95.0|1.449|3.276||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||3.276|1.449|
72589482|NCT00972816|144710496|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 22|1.017|||||TWO_SIDED|95.0|0.676|1.528||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||1.528|0.676|
72589483|NCT00972816|144710496|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 22|0.673|||||TWO_SIDED|95.0|0.448|1.012||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||1.012|0.448|
72589484|NCT00972816|144710496|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 22|1.742|||||TWO_SIDED|95.0|1.156|2.626||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||2.626|1.156|
72589485|NCT00972816|144710496|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 22|0.306|||||TWO_SIDED|95.0|0.204|0.458||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||0.458|0.204|
72589486|NCT00972816|144710496|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 22|0.165|||||TWO_SIDED|95.0|0.11|0.248||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||0.248|0.110|
72589487|NCT00972816|144710496|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 22|0.545|||||TWO_SIDED|95.0|0.363|0.818||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||0.818|0.363|
72589488|NCT00972816|144710496|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 22|0.254|||||TWO_SIDED|95.0|0.17|0.381||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||0.381|0.170|
72414141|NCT05437510|144337244|SUPERIORITY||Efficacy|66.38||||0.0046|TWO_SIDED|95.0|25.952|86.137|||Exact method using binomial distribution|||"Statistical analysis for Germany:~The 2-sided 95% CI for the efficacy was calculated by an exact method assuming a binomial distribution of the number of hospitalizations for all-cause LRTI through Day 151 post-dosing/randomization in the nirsevimab group conditional on the total number in both groups accounting for the follow-up time post-dosing/randomization."||86.137|25.952|0.0046
72589489|NCT00972816|144710496|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 22|0.168|||||TWO_SIDED|95.0|0.112|0.252||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||0.252|0.112|
72589490|NCT00972816|144710496|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 22|0.436|||||TWO_SIDED|95.0|0.29|0.655||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||0.655|0.290|
72589491|NCT00972816|144710496|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 22|0.541|||||TWO_SIDED|95.0|0.361|0.811||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||0.811|0.361|
72589492|NCT00972816|144710496|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 22|1.783|||||TWO_SIDED|95.0|1.188|2.676||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||2.676|1.188|
72589493|NCT00972816|144710496|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 22|0.832|||||TWO_SIDED|95.0|0.555|1.246||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||1.246|0.555|
72589494|NCT00972816|144710496|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 22|0.551|||||TWO_SIDED|95.0|0.367|0.826||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||0.826|0.367|
72589495|NCT00972816|144710496|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 22|1.426|||||TWO_SIDED|95.0|0.95|2.14||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||2.140|0.950|
72589496|NCT00972816|144710496|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 22|3.295|||||TWO_SIDED|95.0|2.196|4.944||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||4.944|2.196|
72589497|NCT00972816|144710496|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 22|1.538|||||TWO_SIDED|95.0|1.026|2.303||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||2.303|1.026|
72589498|NCT00972816|144710496|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 22|1.018|||||TWO_SIDED|95.0|0.679|1.526||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||1.526|0.679|
72589499|NCT00972816|144710496|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 22|2.635|||||TWO_SIDED|95.0|1.754|3.959||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||3.959|1.754|
72589500|NCT00972816|144710496|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 22|0.467|||||TWO_SIDED|95.0|0.311|0.7||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||0.7|0.311|
72589501|NCT00972816|144710496|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 22|0.309|||||TWO_SIDED|95.0|0.206|0.463||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||0.463|0.206|
72589502|NCT00972816|144710496|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 22|0.8|||||TWO_SIDED|95.0|0.532|1.203||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other||1.203|0.532|
72414142|NCT05437510|144337249|SUPERIORITY||Efficacy|82.72|||<|0.0001|TWO_SIDED|95.0|67.826|91.49|||Exact method using binomial distribution|||"Statistical analysis for Overall:~The 2-sided 95% CI for the efficacy was calculated by an exact method assuming a binomial distribution of the number of RSV LRTI hospitalizations through Day 181 post-dosing/randomization in the nirsevimab group conditional on the total number in both groups accounting for the follow-up time post-dosing/randomization."||91.490|67.826|<0.0001
72589503|NCT00972816|144710496|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 22|0.662|||||TWO_SIDED|95.0|0.442|0.992||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||0.992|0.442|
72589504|NCT00972816|144710496|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 22|1.714|||||TWO_SIDED|95.0|1.142|2.572||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||2.572|1.142|
72589505|NCT00972816|144710496|NON_INFERIORITY_OR_EQUIVALENCE|A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.|Geometric mean ratio at day 22|2.589|||||TWO_SIDED|95.0|1.723|3.889||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||3.889|1.723|
72589506|NCT00972816|144710496|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 43|4.975|||||TWO_SIDED|95.0|3.757|6.589||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||6.589|3.757|
72589507|NCT00972816|144710496|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 43|1.168|||||TWO_SIDED|95.0|0.881|1.547||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||1.547|0.881|
72589508|NCT00972816|144710496|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 43|0.88|||||TWO_SIDED|95.0|0.665|1.166||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||1.166|0.665|
72589509|NCT00972816|144710496|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 43|3.219|||||TWO_SIDED|95.0|2.43|4.264||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||4.264|2.430|
72589510|NCT00972816|144710496|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 43|1.07|||||TWO_SIDED|95.0|0.808|1.417||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||1.417|0.808|
72589511|NCT00972816|144710496|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 43|0.72|||||TWO_SIDED|95.0|0.544|0.954||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||0.954|0.544|
72589512|NCT00972816|144710496|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 43|2.509|||||TWO_SIDED|95.0|1.891|3.33||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||3.330|1.891|
72589513|NCT00972816|144710496|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 43|0.235|||||TWO_SIDED|95.0|0.178|0.31||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||0.310|0.178|
72589514|NCT00972816|144710496|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 43|0.177|||||TWO_SIDED|95.0|0.134|0.234||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||0.234|0.134|
72589515|NCT00972816|144710496|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 43|0.647|||||TWO_SIDED|95.0|0.489|0.856||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||0.856|0.489|
72589516|NCT00972816|144710496|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 43|0.215|||||TWO_SIDED|95.0|0.163|0.284||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||0.284|0.163|
72589517|NCT00972816|144710496|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 43|0.145||||||95.0|0.109|0.191||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||0.191|0.109|
72589518|NCT00972816|144710496|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 43|0.504|||||TWO_SIDED|95.0|0.381|0.668||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||0.668|0.381|
72589519|NCT00972816|144710496|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 43|0.754|||||TWO_SIDED|95.0|0.57|0.997||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||0.997|0.570|
72589520|NCT00972816|144710496|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 43|2.756|||||TWO_SIDED|95.0|2.083|3.647||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||3.647|2.083|
72589521|NCT00972816|144710496|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 43|0.916|||||TWO_SIDED|95.0|0.694|1.211||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||1.211|0.694|
72589522|NCT00972816|144710496|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 43|0.616|||||TWO_SIDED|95.0|0.466|1.815||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||1.815|0.466|
72589523|NCT00972816|144710496|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 43|2.149|||||TWO_SIDED|95.0|1.624|2.843||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||2.843|1.624|
72589524|NCT00972816|144710496|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 43|3.656|||||TWO_SIDED|95.0|2.764|4.836||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||4.836|2.764|
72589525|NCT00972816|144710496|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 43|1.216|||||TWO_SIDED|95.0|0.92|1.606||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||1.606|0.920|
72589526|NCT00972816|144710496|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 43|0.818|||||TWO_SIDED|95.0|0.619|1.081||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||1.081|0.619|
72589527|NCT00972816|144710496|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 43|2.85|||||TWO_SIDED|95.0|2.152|3.773||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||3.773|2.152|
72589528|NCT00972816|144710496|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 43|0.332|||||TWO_SIDED|95.0|0.251|0.44||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||0.440|0.251|
72589529|NCT00972816|144710496|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 43|0.224|||||TWO_SIDED|95.0|0.169|0.296||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||0.296|0.169|
72589530|NCT00972816|144710496|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 43|0.78|||||TWO_SIDED|95.0|0.588|1.003||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||1.003|0.588|
72589531|NCT00972816|144710496|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 43|0.673|||||TWO_SIDED|95.0|0.509|0.889||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||0.889|0.509|
72589532|NCT00972816|144710496|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 43|2.345|||||TWO_SIDED|95.0|1.772|3.102||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||3.102|1.772|
72589533|NCT00972816|144710496|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 43|3.485|||||TWO_SIDED|95.0|2.633|4.614||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||4.614|2.633|
72589534|NCT00972816|144710496|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 202|2.624|||||TWO_SIDED|95.0|1.817|3.789||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||3.789|1.817|
72589535|NCT00972816|144710496|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 202|1.096|||||TWO_SIDED|95.0|0.76|1.58||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||1.580|0.760|
72589536|NCT00972816|144710496|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 202|0.888|||||TWO_SIDED|95.0|0.615|1.282||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||1.282|0.615|
72589537|NCT00972816|144710496|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 202|2.12|||||TWO_SIDED|95.0|1.473|3.052||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||3.052|1.473|
72589538|NCT00972816|144710496|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 202|0.876|||||TWO_SIDED|95.0|0.61|1.26||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||1.260|0.610|
72589539|NCT00972816|144710496|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67|Geometric mean ratio at day 202|0.898|||||TWO_SIDED|95.0|0.622|1.298||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||1.298|0.622|
72589540|NCT00972816|144710496|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 202|1.451|||||TWO_SIDED|95.0|1.0|2.105||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||2.105|1.000|
72589541|NCT00972816|144710496|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 202|0.418|||||TWO_SIDED|95.0|0.289|0.603||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||0.603|0.289|
72589542|NCT00972816|144710496|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 202|0.338|||||TWO_SIDED|95.0|0.235|0.487||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||0.487|0.235|
72589543|NCT00972816|144710496|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 202|0.808|||||TWO_SIDED|95.0|0.561|1.165||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||1.165|0.561|
72589544|NCT00972816|144710496|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 202|0.334|||||TWO_SIDED|95.0|0.233|0.479||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||0.479|0.233|
72589545|NCT00972816|144710496|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 202|0.342|||||TWO_SIDED|95.0|0.237|0.494||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||0.494|0.237|
72589546|NCT00972816|144710496|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 202|0.553|||||TWO_SIDED|95.0|0.382|0.801||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||0.801|0.382|
72589547|NCT00972816|144710496|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 202|0.811|||||TWO_SIDED|95.0|0.562|1.169||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||1.169|0.562|
72589548|NCT00972816|144710496|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 202|1.935|||||TWO_SIDED|95.0|1.347|2.78||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||2.780|1.347|
72589549|NCT00972816|144710496|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 202|0.8|||||TWO_SIDED|95.0|0.558|1.147||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||1.147|0.558|
72589550|NCT00972816|144710496|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 202|0.82|||||TWO_SIDED|95.0|0.568|1.184||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||1.184|0.568|
72589551|NCT00972816|144710496|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 202|1.324|||||TWO_SIDED|95.0|0.915|1.917||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||1.917|0.915|
72589552|NCT00972816|144710496|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 202|2.388|||||TWO_SIDED|95.0|1.658|3.438||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||3.438|1.658|
72589553|NCT00972816|144710496|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 202|0.987|||||TWO_SIDED|95.0|0.688|1.416||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||1.416|0.688|
72589554|NCT00972816|144710496|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 202|1.012|||||TWO_SIDED|95.0|0.701|1.46||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||1.460|0.701|
72589555|NCT00972816|144710496|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 202|1.634|||||TWO_SIDED|95.0|1.128|2.366||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||2.366|1.128|
72589556|NCT00972816|144710496|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 202|0.413|||||TWO_SIDED|95.0|0.288|0.592||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||0.592|0.288|
72589557|NCT00972816|144710496|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 202|0.424|||||TWO_SIDED|95.0|0.294|0.61||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||0.610|0.294|
72589558|NCT00972816|144710496|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 202|0.684|||||TWO_SIDED|95.0|0.473|0.99||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||0.990|0.473|
72589559|NCT00972816|144710496|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 202|1.025|||||TWO_SIDED|95.0|0.714|1.473||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||1.473|0.714|
72589560|NCT00972816|144710496|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 202|1.656|||||TWO_SIDED|95.0|1.15|2.385||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||2.385|1.150|
72589561|NCT00972816|144710496|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 202|1.615|||||TWO_SIDED|95.0|1.115|2.339||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||2.339|1.115|
72589562|NCT00972816|144710496|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 387|1.906|||||TWO_SIDED|95.0|1.177|3.087||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||3.087|1.177|
72589563|NCT00972816|144710496|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 387|0.945|||||TWO_SIDED|95.0|0.583|1.533||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||1.533|0.583|
72589564|NCT00972816|144710496|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 387|0.763|||||TWO_SIDED|95.0|0.468|1.245||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||1.245|0.468|
72589565|NCT00972816|144710496|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 387|1.818|||||TWO_SIDED|95.0|1.119|2.956||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||2.956|1.119|
72589566|NCT00972816|144710496|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 387|0.917|||||TWO_SIDED|95.0|0.568|1.481||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||1.481|0.568|
72589567|NCT00972816|144710496|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 387|0.855|||||TWO_SIDED|95.0|0.524|1.396||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||1.396|0.524|
72589568|NCT00972816|144710496|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 387|1.203|||||TWO_SIDED|95.0|0.745|1.943||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||1.943|0.745|
72589569|NCT00972816|144710496|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 387|0.496|||||TWO_SIDED|95.0|0.31|0.794||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||0.794|0.310|
72589570|NCT00972816|144710496|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 387|0.4|||||TWO_SIDED|95.0|0.25|0.641||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||0.641|0.250|
72589571|NCT00972816|144710496|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 387|0.954|||||TWO_SIDED|95.0|0.596|1.528||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||1.528|0.596|
72589572|NCT00972816|144710496|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 387|0.481|||||TWO_SIDED|95.0|0.306|0.758||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||0.758|0.306|
72589573|NCT00972816|144710496|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 387|0.449|||||TWO_SIDED|95.0|0.279|0.722||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||0.722|0.279|
72589574|NCT00972816|144710496|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 387|0.631|||||TWO_SIDED|95.0|0.398|1.002||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||1.002|0.398|
72589575|NCT00972816|144710496|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 387|0.807|||||TWO_SIDED|95.0|0.5|1.304||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||1.304|0.500|
72589576|NCT00972816|144710496|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 387|1.924|||||TWO_SIDED|95.0|1.193|3.102||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||3.102|1.193|
72589577|NCT00972816|144710496|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 387|0.97|||||TWO_SIDED|95.0|0.611|1.541||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||1.541|0.611|
72589578|NCT00972816|144710496|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 387|0.905|||||TWO_SIDED|95.0|0.561|1.46||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||1.460|0.561|
72589579|NCT00972816|144710496|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 387|1.273|||||TWO_SIDED|95.0|0.798|2.03||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||2.030|0.798|
72589580|NCT00972816|144710496|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 387|2.383|||||TWO_SIDED|95.0|1.474|3.851||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||3.851|1.474|
72589581|NCT00972816|144710496|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 387|1.202|||||TWO_SIDED|95.0|0.754|1.915||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||1.915|0.754|
72589582|NCT00972816|144710496|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 387|1.12|||||TWO_SIDED|95.0|0.689|1.821||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||1.821|0.689|
72589583|NCT00972816|144710496|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 387|1.576|||||TWO_SIDED|95.0|0.987|2.516||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||2.516|0.987|
72589584|NCT00972816|144710496|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 387|0.504|||||TWO_SIDED|95.0|0.316|0.805||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||0.805|0.316|
72589585|NCT00972816|144710496|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 387|0.47|||||TWO_SIDED|95.0|0.293|0.754||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||0.754|0.293|
72589586|NCT00972816|144710496|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 387|0.662|||||TWO_SIDED|95.0|0.414|1.056||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||1.056|0.414|
72589587|NCT00972816|144710496|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 387|0.932|||||TWO_SIDED|95.0|0.583|1.492||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||1.492|0.583|
72589588|NCT00972816|144710496|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 387|1.312|||||TWO_SIDED|95.0|0.831|2.071||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||2.071|0.831|
72589589|NCT00972816|144710496|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 387|1.407|||||TWO_SIDED|95.0|0.88|2.249||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||2.249|0.880|
72589590|NCT00972816|144710496|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric Mean Ratio at day 29|5.428|||||TWO_SIDED|95.0|4.0|7.365||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||7.365|4|
72589591|NCT00972816|144710496|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric Mean Ratio at day 29|1.091|||||TWO_SIDED|95.0|0.804|1.481||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||1.481|0.804|
72589592|NCT00972816|144710496|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric Mean Ratio at day 29|0.759|||||TWO_SIDED|95.0|0.559|1.031||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||1.031|0.559|
72589593|NCT00972816|144710496|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric Mean Ratio at day 29|3.499|||||TWO_SIDED|95.0|2.577|4.751||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other||4.751|2.577|
72589594|NCT00972816|144710496|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric Mean Ratio at day 29|0.982|||||TWO_SIDED|95.0|0.722|1.334||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||1.334|0.722|
72589595|NCT00972816|144710496|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric Mean Ratio at day 29|0.699|||||TWO_SIDED|95.0|0.513|0.95||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other||0.95|0.513|
72589596|NCT00972816|144710496|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric Mean Ratio at day 29|2.513|||||TWO_SIDED|95.0|1.846|3.421||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||3.421|1.846|
72589597|NCT00972816|144710496|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric Mean Ratio at day 29|0.201|||||TWO_SIDED|95.0|0.149|0.272||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||0.272|0.149|
72589598|NCT00972816|144710496|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric Mean Ratio at day 29|0.14|||||TWO_SIDED|95.0|0.103|0.189||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||0.189|0.103|
72589599|NCT00972816|144710496|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric Mean Ratio at day 29|0.645|||||TWO_SIDED|95.0|0.476|0.873||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||0.873|0.476|
72589600|NCT00972816|144710496|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric Mean Ratio at day 29|0.181|||||TWO_SIDED|95.0|0.134|0.245||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other||0.245|0.134|
72589601|NCT00972816|144710496|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric Mean Ratio at day 29|0.129|||||TWO_SIDED|95.0|0.095|0.174||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||0.174|0.095|
72589602|NCT00972816|144710496|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67|Geometric Mean Ratio at day 29|0.463|||||TWO_SIDED|95.0|0.341|0.628||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other||0.628|0.341|
72589603|NCT00972816|144710496|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric Mean Ratio at day 29|0.696|||||TWO_SIDED|95.0|0.514|0.943||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other||0.943|0.514|
72589604|NCT00972816|144710496|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric Mean Ratio at day 29|3.207|||||TWO_SIDED|95.0|2.368|4.343||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||4.343|2.368|
72589605|NCT00972816|144710496|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric Mean Ratio at day 29|0.9|||||TWO_SIDED|95.0|0.665|1.218||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||1.218|0.665|
72589606|NCT00972816|144710496|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric Mean Ratio at day 29|0.64|||||TWO_SIDED|95.0|0.472|0.868||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||0.868|0.472|
72589607|NCT00972816|144710496|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric Mean Ratio at day 29|2.303|||||TWO_SIDED|95.0|1.7|3.121||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||3.121|1.7|
72589608|NCT00972816|144710496|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric Mean Ratio at day 29|4.608|||||TWO_SIDED|95.0|3.398|6.249||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||6.249|3.398|
72589609|NCT00972816|144710496|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric Mean Ratio at day 29|1.293|||||TWO_SIDED|95.0|0.954|1.753||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||1.753|0.954|
72589610|NCT00972816|144710496|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric Mean Ratio at day 29|0.92|||||TWO_SIDED|95.0|0.677|1.249||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||1.249|0.677|
72589611|NCT00972816|144710496|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric Mean Ratio at day 29|3.31|||||TWO_SIDED|95.0|2.436|4.496||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other||4.496|2.436|
72589612|NCT00972816|144710496|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric Mean Ratio at day 29|0.281|||||TWO_SIDED|95.0|0.207|0.38||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||0.38|0.207|
72589613|NCT00972816|144710496|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric Mean Ratio at day 29|0.2|||||TWO_SIDED|95.0|0.147|0.271||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||0.271|0.147|
72589614|NCT00972816|144710496|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric Mean Ratio at day 29|0.718|||||TWO_SIDED|95.0|0.529|0.975||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||0.975|0.529|
72414143|NCT05437510|144337249|SUPERIORITY||Efficacy|86.13|||<|0.0001|TWO_SIDED|95.0|60.34|96.464|||Exact method using binomial distribution|||"Statistical analysis for France:~The 2-sided 95% CI for the efficacy was calculated by an exact method assuming a binomial distribution of the number of RSV LRTI hospitalizations through Day 181 post-dosing/randomization in the nirsevimab group conditional on the total number in both groups accounting for the follow-up time post-dosing/randomization."||96.464|60.340|<0.0001
72589615|NCT00972816|144710496|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric Mean Ratio at day 29|0.712|||||TWO_SIDED|95.0|0.524|0.966||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||0.966|0.524|
72589616|NCT00972816|144710496|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric Mean Ratio at day 29|2.56|||||TWO_SIDED|95.0|1.886|3.474||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||3.474|1.886|
72589617|NCT00972816|144710496|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric Mean Ratio at day 29|3.597|||||TWO_SIDED|95.0|2.646|4.89||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other||4.89|2.646|
72589618|NCT01953601|144710516|SUPERIORITY||Difference in Least Squares Mean (LSM)|0.1||||0.6734|TWO_SIDED|97.51|-0.3|0.4|||Longitudinal ANCOVA||Difference in LSM = Arm A - Arm C||Analysis model includes categorical factors of geographic region, time, treatment, gender, APOE genotype, baseline use of Vitamin E, baseline use of AChEI, and the interaction of time by treatment, with baseline value, the interaction of baseline value and time, the baseline value of MMSE and the baseline value of age included as continuous covariates.|0.4|-0.3|0.6734
72589619|NCT01953601|144710516|SUPERIORITY||Difference in Least Squares Means (LSM)|0.4||||0.0141|TWO_SIDED|97.51|0.0|0.8|||Longitudinal ANCOVA||Difference in LSM = Arm B - Arm C||Analysis model includes categorical factors of geographic region, time, treatment, gender, APOE genotype, baseline use of Vitamin E, baseline use of AChEI, and the interaction of time by treatment, with baseline value, the interaction of baseline value and time, the baseline value of MMSE and the baseline value of age included as continuous covariates.|0.8|0.0|0.0141
72589620|NCT01953601|144710518|OTHER||Difference in % vs Placebo|4.32|||||TWO_SIDED|95.0|0.4|8.31|||||Difference in % = Arm A - Arm C|||8.31|0.40|
72589621|NCT01953601|144710518|OTHER||Difference in % vs Placebo|5.17|||||TWO_SIDED|95.0|1.33|9.09|||||Difference in % = Arm B - Arm C|||9.09|1.33|
72589622|NCT01953601|144710519|OTHER||Difference in % vs Placebo|2.08|||||TWO_SIDED|95.0|-0.84|5.1|||||Difference in % = Arm A - Arm C|||5.10|-0.84|
72589623|NCT01953601|144710519|OTHER||Difference in % vs Placebo|5.58|||||TWO_SIDED|95.0|2.35|8.99|||||Difference in % = Arm B - Arm C|||8.99|2.35|
72589624|NCT01953601|144710520|OTHER||Difference in % vs Placebo|-6.79|||||TWO_SIDED|95.0|-16.16|2.68|||||Difference in % = Arm A - Arm C|||2.68|-16.16|
72589625|NCT01953601|144710520|OTHER||Difference in % vs Placebo|-10.68|||||TWO_SIDED|95.0|-20.16|-1.04|||||Difference in % = Arm B - Arm C|||-1.04|-20.16|
72589626|NCT01953601|144710521|OTHER||Difference in % vs Placebo|-2.42|||||TWO_SIDED|95.0|-6.03|0.61|||||Difference in % = Arm A - Arm C|||0.61|-6.03|
72589627|NCT01953601|144710521|OTHER||Difference in % vs Placebo|-2.38|||||TWO_SIDED|95.0|-6.01|0.71|||||Difference in % = Arm B - Arm C|||0.71|-6.01|
72589628|NCT01953601|144710522|SUPERIORITY||Hazard Ratio (HR)|1.301||||0.0222|TWO_SIDED|97.51|1.005|1.684|||Regression, Cox||HR = Arm A / Arm C||Based on Cox regression model with Efron's method of tie handling with treatment, background AD treatment (use, no use), sex, APOE4 status (carrier, non-carrier) and baseline use of Vitamin E as categorical covariates and age and baseline MMSE value as continuous covariates.|1.684|1.005|0.0222
72589629|NCT01953601|144710522|SUPERIORITY||Hazard Ratio (HR)|1.382||||0.005|TWO_SIDED|97.51|1.067|1.79|||Regression, Cox||HR = Arm B / Arm C||Based on Cox regression model with Efron's method of tie handling with treatment, background AD treatment (use, no use), sex, APOE4 status (carrier, non-carrier) and baseline use of Vitamin E as categorical covariates and age and baseline MMSE value as continuous covariates.|1.790|1.067|0.0050
72589630|NCT01953601|144710523|SUPERIORITY||Difference in Least Squares Mean (LSM)|0.0||||0.9109|TWO_SIDED|97.51|-0.3|0.4|||Longitudinal ANCOVA||Difference in LSM = Arm A - Arm C||Analysis model includes categorical factors of geographic region, time, treatment, gender, APOE genotype, baseline use of Vitamin E, baseline use of AChEI, and the interaction of time by treatment, with baseline value, the interaction of baseline value and time, the baseline value of MMSE and the baseline value of age included as continuous covariates.|0.4|-0.3|0.9109
72589631|NCT01953601|144710523|SUPERIORITY||Difference in Least Squares Mean (LSM)|0.3||||0.0824|TWO_SIDED|97.51|-0.1|0.7|||Longitudinal ANCOVA||Difference in LSM = Arm B - Arm C||Analysis model includes categorical factors of geographic region, time, treatment, gender, APOE genotype, baseline use of Vitamin E, baseline use of AChEI, and the interaction of time by treatment, with baseline value, the interaction of baseline value and time, the baseline value of MMSE and the baseline value of age included as continuous covariates.|0.7|-0.1|0.0824
72589632|NCT01953601|144710524|SUPERIORITY||Difference in Least Squares Mean (LSM)|0.0||||0.951|TWO_SIDED|97.51|-0.2|0.2|||Longitudinal ANCOVA||Difference in LSM = Arm A - Arm C||Analysis model includes categorical factors of geographic region, time, treatment, gender, APOE genotype, baseline use of Vitamin E, baseline use of AChEI, and the interaction of time by treatment, with baseline value, the interaction of baseline value and time, the baseline value of MMSE and the baseline value of age included as continuous covariates.|0.2|-0.2|0.9510
72589633|NCT01953601|144710524|SUPERIORITY||Difference in Least Squares Mean (LSM)|0.0||||0.9392|TWO_SIDED|97.51|-0.2|0.2|||Longitudinal ANCOVA||Difference in LSM = Arm B - Arm C||Analysis model includes categorical factors of geographic region, time, treatment, gender, APOE genotype, baseline use of Vitamin E, baseline use of AChEI, and the interaction of time by treatment, with baseline value, the interaction of baseline value and time, the baseline value of MMSE and the baseline value of age included as continuous covariates.|0.2|-0.2|0.9392
72589634|NCT01953601|144710525|SUPERIORITY||Difference in Least Squares Mean (LSM)|-0.4||||0.1133|TWO_SIDED|97.51|-1.0|0.2|||Longitudinal ANCOVA||Difference in LSM = Arm A - Arm C||Analysis model includes categorical factors of geographic region, time, treatment, gender, APOE genotype, baseline use of Vitamin E, baseline use of AChEI, and the interaction of time by treatment, with baseline value, the interaction of baseline value and time, the baseline value of MMSE and the baseline value of age included as continuous covariates.|0.2|-1.0|0.1133
72589635|NCT01953601|144710525|SUPERIORITY||Difference in Least Squares Mean (LSM)|-0.6||||0.031|TWO_SIDED|97.51|-1.2|0.0|||Longitudinal ANCOVA||Difference in LSM = Arm B - Arm C||Analysis model includes categorical factors of geographic region, time, treatment, gender, APOE genotype, baseline use of Vitamin E, baseline use of AChEI, and the interaction of time by treatment, with baseline value, the interaction of baseline value and time, the baseline value of MMSE and the baseline value of age included as continuous covariates.|0.0|-1.2|0.0310
72589636|NCT01953601|144710526|SUPERIORITY||Difference in Least Squares Mean (LSM)|-0.05|||<|0.0001|TWO_SIDED|97.51|-0.06|-0.04|||Longitudinal ANCOVA||Difference in LSM = Arm A - Arm C||Analysis model includes categorical factors of geographic region, time, treatment, gender, APOE genotype, baseline use of Vitamin E, baseline use of AChEI, and the interaction of time by treatment, with baseline value, the interaction of baseline value and time, the baseline value of MMSE and the baseline value of age included as continuous covariates.|-0.04|-0.06|<0.0001
72589637|NCT01953601|144710526|SUPERIORITY||Difference in Least Squares Mean (LSM)|-0.06|||<|0.0001|TWO_SIDED|97.51|-0.07|-0.05|||Longitudinal ANCOVA||Difference in LSM = Arm B - Arm C||Analysis model includes categorical factors of geographic region, time, treatment, gender, APOE genotype, baseline use of Vitamin E, baseline use of AChEI, and the interaction of time by treatment, with baseline value, the interaction of baseline value and time, the baseline value of MMSE and the baseline value of age included as continuous covariates.|-0.05|-0.07|<0.0001
72589638|NCT01953601|144710527|SUPERIORITY||Difference in Least Squares Mean (LSM)|-1.0||||0.096|TWO_SIDED|97.51|-2.4|0.4|||Longitudinal ANCOVA||Difference in LSM = Arm A - Arm C||Analysis model includes categorical factors of geographic region, time, treatment, gender, APOE genotype, baseline use of Vitamin E, baseline use of AChEI, and the interaction of time by treatment, with baseline value, the interaction of baseline value and time, the baseline value of MMSE and the baseline value of age included as continuous covariates.|0.4|-2.4|0.0960
72414144|NCT05437510|144337249|SUPERIORITY||Efficacy|85.92||||0.0002|TWO_SIDED|95.0|52.85|97.311|||Exact method using binomial distribution|||"Statistical analysis for UK:~The 2-sided 95% CI for the efficacy was calculated by an exact method assuming a binomial distribution of the number of RSV LRTI hospitalizations through Day 181 post-dosing/randomization in the nirsevimab group conditional on the total number in both groups accounting for the follow-up time post-dosing/randomization."||97.311|52.850|0.0002
72589639|NCT01953601|144710527|SUPERIORITY||Difference in Least Squares Mean (LSM)|-1.7||||0.011|TWO_SIDED|97.51|-3.2|-0.2|||Longitudinal ANCOVA||Difference in LSM = Arm B - Arm C||Analysis model includes categorical factors of geographic region, time, treatment, gender, APOE genotype, baseline use of Vitamin E, baseline use of AChEI, and the interaction of time by treatment, with baseline value, the interaction of baseline value and time, the baseline value of MMSE and the baseline value of age included as continuous covariates.|-0.2|-3.2|0.0110
72589640|NCT02230696|144710529|EQUIVALENCE|provides 85% power of success|Equivalence ratio|94.19|||||TWO_SIDED|90.0|84.77|104.52|||Trial and Error approach|||||104.52|84.77|
72589641|NCT02230696|144710530|EQUIVALENCE|provides 85% power of success|Equivalence ratio|94.68|||||TWO_SIDED|90.0|84.86|105.54|||Trial and Error approach|||||105.54|84.86|
72589642|NCT02223650|144710536|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.75||||0.01|TWO_SIDED|95.0|-1.42|-0.07||P-value is calculated for one-sided hypothesis test.|ANCOVA|Comparison of mean 8-wk distance control using ANCOVA adjusted for baseline distance control pre-study spectacle wear, and pre-study IXT treatment|Difference in mean distance control (overminus - observation) and 95% CI from ANCOVA model adjusting for baseline control, pre-study spectacle wear, and pre-study treatment for IXT. + difference suggests observation group worse than overminus group|||-0.07|-1.42|0.01
72589643|NCT02223650|144710537|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.24||||0.14|TWO_SIDED|95.0|-0.68|0.19||P-value is calculated for one-sided hypothesis test.|ANCOVA|Comparison of mean 8-wk near control using ANCOVA adjusted for baseline near control pre-study spectacle wear, and pre-study IXT treatment.|Comparison of mean 8-wk distance control using ANCOVA adjusted for baseline near control pre-study spectacle wear, and pre-study IXT treatment.|||0.19|-0.68|0.14
72589644|NCT02223650|144710540|SUPERIORITY_OR_OTHER||Risk Difference (RD)|21.0||||0.07|TWO_SIDED|95.0|-6.0|45.0||The p-value was not adjusted for multiple comparisons.|Chi-squared|||||45|-6|0.07
72589645|NCT02223650|144710548|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.001||||0.54|TWO_SIDED|95.0|-23.0|24.0||The p-value was not adjusted for multiple comparisons.|Chi-squared|||||24|-23|0.54
72414145|NCT05437510|144337249|SUPERIORITY||Efficacy|74.39||||0.0054|TWO_SIDED|95.0|29.077|92.525|||Exact method using binomial distribution|||"Statistical analysis for Germany:~The 2-sided 95% CI for the efficacy was calculated by an exact method assuming a binomial distribution of the number of RSV LRTI hospitalizations through Day 181 post-dosing/randomization in the nirsevimab group conditional on the total number in both groups accounting for the follow-up time post-dosing/randomization."||92.525|29.077|0.0054
72589646|NCT02821338|144710560|EQUIVALENCE|90% confidence interval falls within 80.00-125.00%|Test/Reference ratio|0.9863|||||TWO_SIDED|90.0|0.9598|1.0134||||||90% confidence interval of the geometric mean ratio of test/reference||1.0134|0.9598|
72589647|NCT02821338|144710561|EQUIVALENCE|90% confidence interval falls within 80.00-125.00%|Test/Reference Ratio|0.9785|||||TWO_SIDED|90.0|0.9484|1.0095||||||||1.0095|0.9484|
72589648|NCT02821338|144710562|EQUIVALENCE|90% confidence interval falls within 80.00-125.00%|Test/Reference Ratio|1.047|||||TWO_SIDED|90.0|1.0079|1.0877||||||||1.0877|1.0079|
72589649|NCT00712881|144710603|OTHER|||||||0.154||||||Threshold for significance at 0.05 level.|2-sided, binomial proportions|||||||0.154
72589650|NCT01194999|144710612|SUPERIORITY_OR_OTHER|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: No significant difference from baseline to final follow-up.||||0.001
72589651|NCT03834974|144710638|SUPERIORITY||||||<|0.0286|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: There would be no difference in change in intent to tan outdoors 10 or more times in the next year.||||<0.0286
72589652|NCT03834974|144710638|SUPERIORITY|||||||0.0937|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: There would be no difference in change in in intent to tan later in life.||||0.0937
72589653|NCT03834974|144710642|SUPERIORITY||||||<|0.0002|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: There would be no difference in tanning outside at follow-up||||<0.0002
72589654|NCT00823043|144710651|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||||||<.001
72589655|NCT00823043|144710652|SUPERIORITY_OR_OTHER|||||||0.024||95.0|||||t-test, 2 sided|||||||0.024
72589656|NCT00823043|144710653|SUPERIORITY_OR_OTHER|||||||0.75||95.0|||||t-test, 2 sided|||||||0.75
72589657|NCT00823043|144710654|SUPERIORITY_OR_OTHER|||||||0.69||95.0|||||t-test, 2 sided|||||||0.69
72589658|NCT03557931|144710683|SUPERIORITY||LS Mean Difference|0.18|STANDARD_ERROR_OF_MEAN|1.02||0.858|TWO_SIDED|90.0|-1.51|1.88|||MMRM Method|||Mixed model repeated measures (MMRM) analysis model is performed with change from baseline (least square (LS) Mean estimate for observed value from separate model using observed values) at week 12 as response; treatment, site (pooled where necessary), visit, treatment\*visit, and visit\*baseline as fixed effects, and baseline as a covariate.|Cohen's d Effect Size was defined as: (t-value for the least squares mean pairwise difference of ASP4345 50 mg vs placebo) \* sqrt(1/n\[PLACEBO\] + 1/n\[ASP4345\]). The Cohen's d Effect Size value for ASP4345 50 mg vs placebo is 0.035.|1.88|-1.51|0.858
72589659|NCT03557931|144710683|SUPERIORITY||LS Mean Difference|-0.28|STANDARD_ERROR_OF_MEAN|0.99|||TWO_SIDED|90.0|-1.93|1.36|||0.775|||MMRM analysis model is performed with change from baseline (LS Mean estimate for observed value from separate model using observed values) at week 12 as response; treatment, site (pooled where necessary), visit, treatment\*visit, and visit\*baseline as fixed effects, and baseline as a covariate.|Cohen's d Effect Size was defined as: (t-value for the least squares mean pairwise difference of ASP4345 150 mg vs placebo) \* sqrt(1/n\[PLACEBO\] + 1/n\[ASP4345\]). The Cohen's d Effect Size value for ASP4345 150 mg vs placebo is - 0.053.|1.36|-1.93|
72589660|NCT03557931|144710689|SUPERIORITY||LS Mean Difference|0.75|STANDARD_ERROR_OF_MEAN|1.6||0.639|TWO_SIDED|90.0|-1.9|3.41|||ANCOVA|||Analysis of covariance (ANCOVA) model is performed with change from baseline (LS Mean estimate for observed value from separate model using observed values) at the Week 12 timepoint as response, treatment and site (pooled where necessary) and baseline as a covariate.||3.41|-1.90|0.639
72589661|NCT03557931|144710689|SUPERIORITY||LS Mean Difference|-0.55|STANDARD_ERROR_OF_MEAN|1.54||0.721|TWO_SIDED|90.0|-3.11|2.01|||ANCOVA|||ANCOVA model is performed with change from baseline (LS Mean estimate for observed value from separate model using observed values) at the Week 12 timepoint as response, treatment and site (pooled where necessary) and baseline as a covariate.||2.01|-3.11|0.721
72589662|NCT00737204|144710691|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|95.0|||||ANCOVA|||||||<0.001
72589663|NCT00737204|144710692|SUPERIORITY_OR_OTHER|||||||0.01|TWO_SIDED|95.0|||||ANCOVA|||Repeated measure analysis||||.01
72589664|NCT00737204|144710693|SUPERIORITY_OR_OTHER||||||>=|0.805||95.0|||||Paired t-tests|||Null hypothesis: CD4 levels for both the Armodafinil and Placebo groups will not change significantly between baseline and week 4.||||>=.805
72589665|NCT02989649|144710745|OTHER||Least Square Mean (LSM)|-1.25|STANDARD_ERROR_OF_MEAN|0.098|<|0.001|TWO_SIDED|95.0|-1.44|-1.05|||Regression, Linear||The LSM and CI are from Mixed effect Model Repeat Measurement (MMRM) model, that used visit as a predictor and baseline value as a covariate. For change from baseline, covariance structure=Unstructured.|Statistical analysis for data at Baseline compared to the data at Month 6||-1.05|-1.44|<0.001
72589666|NCT02989649|144710746|OTHER|||||||0.423|||||||Regression, Linear|||Statistical analysis for subgroup: Prior therapy of diabetes mellitus, Ever used or Never used||||0.423
72589667|NCT02989649|144710746|OTHER|||||||0.747|||||||Regression, Linear|||Statistical analysis for subgroup: Sex, Male or Female||||0.747
72589668|NCT02989649|144710746|OTHER||||||<|0.001|||||||Regression, Linear|||Statistical analysis for subgroup: Age, \<45 or \>=45 to \<65 years or \>=65 years||||<0.001
72589669|NCT02989649|144710746|OTHER|||||||0.99|||||||Regression, Linear|||Statistical analysis for subgroup: Cardiovascular risk group, Yes or No||||0.990
72589670|NCT02989649|144710746|OTHER|||||||0.841|||||||Regression, Linear|||Statistical analysis for subgroup: Therapy type, Monotherapy or Combined therapy||||0.841
72589671|NCT02989649|144710746|OTHER|||||||0.847|||||||Regression, Linear|||Statistical analysis for subgroup: Baseline BMI, \<25 or 25 to \<30 or \>=30 kg/m\^2||||0.847
72589672|NCT02989649|144710746|OTHER||||||<|0.001|||||||Regression, Linear|||Statistical analysis for subgroup: Initial glycemic control, \<7% or \>=7%||||<0.001
72589673|NCT02989649|144710749|OTHER||Least Square Mean (LSM)|-0.95|STANDARD_ERROR_OF_MEAN|0.17|||TWO_SIDED|95.0|-1.29|-0.62|||||The LSM and CI are from Mixed effect Model Repeat Measurement (MMRM) model, that used visit as a predictor and baseline value as a covariate. For change from baseline, covariance structure=Unstructured.|Statistical analysis for data at Baseline compared to the data at Month 3||-0.62|-1.29|
72589674|NCT02989649|144710749|OTHER||Least Square Mean (LSM)|-0.87|STANDARD_ERROR_OF_MEAN|0.245|||TWO_SIDED|95.0|-1.36|-0.39|||||The LSM and CI are from Mixed effect Model Repeat Measurement (MMRM) model, that used visit as a predictor and baseline value as a covariate. For change from baseline, covariance structure=Unstructured.|Statistical analysis for data at Baseline compared to the data at Month 6||-0.39|-1.36|
72589675|NCT02989649|144710750|OTHER||Least Square Mean (LSM)|-0.95|STANDARD_ERROR_OF_MEAN|0.117|||TWO_SIDED|95.0|-1.18|-0.72|||||The LSM and CI are from Mixed effect Model Repeat Measurement (MMRM) model, that used visit as a predictor and baseline value as a covariate. For change from baseline, covariance structure=Unstructured.|Statistical analysis for data at Baseline compared to the data at Month 3||-0.72|-1.18|
72589676|NCT02989649|144710750|OTHER||Least Square Mean|-1.25|STANDARD_ERROR_OF_MEAN|0.098|||TWO_SIDED|95.0|-1.44|-1.05|||||The LSM and CI are from Mixed effect Model Repeat Measurement (MMRM) model, that used visit as a predictor and baseline value as a covariate. For change from baseline, covariance structure=Unstructured.|Statistical analysis for data at Baseline compared to the data at Month 6||-1.05|-1.44|
72589677|NCT00282113|144710784|SUPERIORITY_OR_OTHER||||||>|0.5||95.0|||||Mixed-effects regression|||||||>0.5
72589678|NCT00282113|144710785|SUPERIORITY_OR_OTHER|||||||0.06||95.0|||||Chi-squared|||||||0.06
72589679|NCT00282113|144710786|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||ANOVA|||||||>0.05
72589680|NCT02949843|144710792|OTHER|||||||0.6|||||||Fisher Exact|||Null Hypothesis is that each arm has equal rates of smoking history.||||0.6
72589681|NCT03852628|144710806|SUPERIORITY||Odds Ratio (OR)|0.17||||0.08|TWO_SIDED|95.0|0.02|1.22|||Mixed Models Analysis|Modeled the probability of having a reduction in AUD||The Placebo arm served as the reference group.||1.22|0.02|0.08
72589682|NCT03852628|144710807|SUPERIORITY||Odds Ratio (OR)|0.76||||0.69|TWO_SIDED|95.0|0.2|2.97|||Mixed Models Analysis|Modeled the probability of reduction in PTSD symptom.||The placebo arm served as the reference group.||2.97|0.20|0.690
72589683|NCT03852628|144710808|SUPERIORITY||Odds Ratio (OR)|0.63||||0.52|TWO_SIDED|95.0|0.15|2.66|||Mixed Models Analysis|Modeled the probability of have both a reduction in PTSD and AUD||The Placebo arm served as the reference group.||2.66|0.15|0.52
72589684|NCT00556933|144710809|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0004|TWO_SIDED||||||Chi-squared|||||||0.0004
72589685|NCT00556933|144710810|SUPERIORITY_OR_OTHER_LEGACY|||||||0.45|TWO_SIDED||||||General Linear Model|||||||0.45
72589686|NCT00556933|144710811|SUPERIORITY_OR_OTHER_LEGACY|||||||0.53|TWO_SIDED||||||Fisher Exact|||||||0.53
72589687|NCT00556933|144710812|SUPERIORITY_OR_OTHER_LEGACY|||||||0.463|TWO_SIDED||||||Fisher Exact|||||||0.463
72589688|NCT00556933|144710813|SUPERIORITY_OR_OTHER_LEGACY|||||||0.67|TWO_SIDED||||||Kaplan-Meier|||||||0.67
72589689|NCT00556933|144710814|SUPERIORITY_OR_OTHER_LEGACY|||||||0.193|TWO_SIDED||||||Fisher Exact|||||||0.193
72589690|NCT00556933|144710815|SUPERIORITY_OR_OTHER_LEGACY|||||||0.422|TWO_SIDED||||||Fisher Exact|||||||0.422
72589691|NCT00556933|144710816|SUPERIORITY_OR_OTHER_LEGACY|||||||0.871|TWO_SIDED||||||Fisher Exact|||||||0.871
72589692|NCT00556933|144710817|SUPERIORITY_OR_OTHER_LEGACY|||||||0.068|TWO_SIDED||||||Kruskal-Wallis|||||||0.068
72589693|NCT00556933|144710818|SUPERIORITY_OR_OTHER_LEGACY|||||||0.67|TWO_SIDED||||||Fisher Exact|||||||0.67
72589694|NCT00556933|144710819|SUPERIORITY_OR_OTHER_LEGACY|||||||0.21|TWO_SIDED||||||Fisher Exact|||||||0.21
72589695|NCT00556933|144710820|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4|TWO_SIDED||||||Kruskal-Wallis|||||||0.40
72589696|NCT00746564|144710822|SUPERIORITY_OR_OTHER||percentage of recordings|100.0|||||TWO_SIDED|95.0|100.0|100.0||||||"The sensitivity was calculated for each recording and for each subject as follows:~Amount of time (sec) R waves recorded on surface ECG were detected on in-clinic recordings/Total amount of time (sec) R waves were recorded on surface ECG"||100|100|
72589697|NCT00746564|144710823|SUPERIORITY_OR_OTHER||percentage of clinical recordings|98.1|||||TWO_SIDED|95.0|95.7|100.0||||||"The sensitivity was calculated for each recording during the treadmill test and for each subject as follows:~Amount of time (sec) R waves recorded on surface ECG were detected on in-clinic recordings/Total amount of time (sec) R waves were recorded on surface ECG"||100|95.7|
72589698|NCT00746564|144710824|SUPERIORITY_OR_OTHER||percentage of recordings|98.0|||||TWO_SIDED|95.0|95.5|100.0||||||"The sensitivity was calculated for each recording and for each subject during the hand to hand and hand to shoulder maneuvers as follows:~Amount of time (sec) R waves recorded on surface ECG were detected on in-clinic recordings/Total amount of time (sec) R waves were recorded on surface ECG"||100|95.5|
72589699|NCT00746564|144710825|SUPERIORITY_OR_OTHER||percentage of recordings|98.9|||||TWO_SIDED|95.0|96.7|100.0||||||"The positive predictive value (PPV) was calculated for each recording and for each subject during the in-clinic recording at rest as follows:~Amount of time (sec) R waves recorded on surface ECG were detected on in-clinic recording / Total amount of time (sec) R waves were recorded by device during in-clinic recording"||100|96.7|
72589700|NCT00746564|144710826|SUPERIORITY_OR_OTHER||percentage of recording|77.1|||||TWO_SIDED|95.0|65.9|88.4||||||"The positive predictive value (PPV) was calculated for each recording and for each subject for the in-clinic recording during the treadmill exercise as follows:~Amount of time (sec) R waves recorded on surface ECG were detected on in-clinic recording / Total amount of time (sec) R waves were recorded by device during in-clinic recording"||88.4|65.9|
72589701|NCT00746564|144710827|SUPERIORITY_OR_OTHER||Percentage of recordings|85.0|||||TWO_SIDED|95.0|78.3|91.7||||||"The positive predictive value (PPV) was calculated for each recording and for each subject during Hand to Hand and Hand to Shoulder Maneuvers as follows:~Amount of time (sec) R waves recorded on surface ECG were detected on in-clinic recording / Total amount of time (sec) R waves were recorded by device during in-clinic recording"||91.7|78.3|
72589702|NCT00746564|144710828|SUPERIORITY_OR_OTHER||percentage of interpretable recording|99.2|||||TWO_SIDED|95.0|98.5|100.0||||||"The proportion of recording time during which the device recording was interpretable was calculated for each weekly Patient Activator recording and for each subject as follows:~Duration (sec) of interpretable recording / Total duration of recording time (sec)"||100|98.5|
72589703|NCT00746564|144710829|SUPERIORITY_OR_OTHER||percentage of interpretable recording|92.3|||||TWO_SIDED|95.0|91.9|92.6||||||"The proportion of recording time during which the device recording was interpretable for each automatically triggered/symptom driven recording and for each subject was calculated as follows:~Duration of interpretable recording / Total duration of recording time"||92.6|91.9|
72589704|NCT00746564|144710830|SUPERIORITY_OR_OTHER||percentage of inappropriate recordings|86.2|||||TWO_SIDED|95.0|79.4|91.0||||||||91.0|79.4|
72589705|NCT00746564|144710831|SUPERIORITY_OR_OTHER||percentage of inappropriate recordings|63.2|||||TWO_SIDED|95.0|48.1|76.2||||||||76.2|48.1|
72589706|NCT00986921|144710858|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.87||||0.05|TWO_SIDED|95.0|0.0|3.0|||t-test, 1 sided|Data was not distributed normally. After log transformation, the log values were distributed normally.||||3|0|0.05
72414146|NCT05437510|144337250|SUPERIORITY||Efficacy|41.89|||<|0.0001|TWO_SIDED|95.0|23.073|56.333|||Exact method using binomial distribution|||"Statistical analysis for Overall:~The 2-sided 95% CI for the efficacy was calculated by an exact method assuming a binomial distribution of the number of hospitalizations for all-cause LRTI through day 181 post-dosing/randomization in the nirsevimab group conditional on the total number in both groups accounting for the follow-up time post-dosing/randomization."||56.333|23.073|<0.0001
72589707|NCT00986921|144710859|SUPERIORITY_OR_OTHER|||||||0.49|TWO_SIDED|95.0||||A threshold value of p of 0.05 was considered significant.|Chi-squared|||The null hypothesis was that the groups would vary, with a p values of less than 0.05.||||0.49
72589708|NCT00986921|144710860|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||Chi-squared|||||||0.001
72589709|NCT02778074|144710881|SUPERIORITY||Mean Difference (Final Values)|-2.34|||<|0.001|TWO_SIDED||||||ANCOVA|||||||<0.001
72589710|NCT01817582|144710891|OTHER||Least square (LS) mean difference|0.3||||0.6199|TWO_SIDED|95.0|-0.7|1.3||Threshold for significance at 0.05 level.|Mixed Models Analysis|||Analysis was performed using MMRM method.||1.3|-0.7|0.6199
72589711|NCT01817582|144710891|OTHER||LS mean difference|0.1||||0.807|TWO_SIDED|95.0|-0.9|1.2||Threshold for significance at 0.05 level.|Mixed Models Analysis|||Analysis was performed using MMRM method.||1.2|-0.9|0.8070
72589712|NCT01817582|144710891|OTHER||LS mean difference|-0.1||||0.8068|TWO_SIDED|95.0|-1.1|0.9||Threshold for significance at 0.05 level.|Mixed Models Analysis|||Analysis was performed using MMRM method.||0.9|-1.1|0.8068
72589713|NCT01817582|144710892|OTHER||LS mean difference|-4.4||||0.2296|TWO_SIDED|95.0|-11.6|2.8||Threshold for significance at 0.05 level.|Mixed Models Analysis|||Analysis was performed using MMRM method.||2.8|-11.6|0.2296
72589714|NCT01817582|144710892|OTHER||LS mean difference|-4.9||||0.189|TWO_SIDED|95.0|-12.3|2.5||Threshold for significance at 0.05 level.|Mixed Models Analysis|||Analysis was performed using MMRM method.||2.5|-12.3|0.1890
72589715|NCT01817582|144710892|OTHER||LS mean difference|-0.5||||0.8836|TWO_SIDED|95.0|-7.7|6.7||Threshold for significance at 0.05 level.|Mixed Models Analysis|||Analysis was performed using MMRM method.||6.7|-7.7|0.8836
72589716|NCT03963232|144710917|SUPERIORITY||LS Mean Difference|-1.82|STANDARD_ERROR_OF_MEAN|0.26|<|0.0001|TWO_SIDED|95.0|-2.32|-1.32|||Mixed Models Analysis|||||-1.32|-2.32|<.0001
72589717|NCT03963232|144710918|SUPERIORITY||Odds Ratio (OR)|2.674|||<|0.0001|TWO_SIDED|95.0|2.01|3.557|||GLIMMIX|||30% responder||3.557|2.010|<.0001
72589718|NCT03963232|144710918|SUPERIORITY||Odds Ratio (OR)|2.481|||<|0.0001|TWO_SIDED|95.0|1.869|3.293|||GLIMMIX|||50% responder||3.293|1.869|<.0001
72589719|NCT03963232|144710918|SUPERIORITY||Odds Ratio (OR)|2.824|||<|0.0001|TWO_SIDED|95.0|2.007|3.972|||GLIMMIX|||75% responder||3.972|2.007|<.0001
72589720|NCT03963232|144710918|SUPERIORITY||Odds Ratio (OR)|3.309|||<|0.0001|TWO_SIDED|95.0|1.989|5.504|||GLIMMIX|||100% responder||5.504|1.989|<.0001
72589721|NCT03963232|144710919|SUPERIORITY||LS Mean Difference|7.07|STANDARD_DEVIATION|0.95|<|0.0001|TWO_SIDED|95.0|5.2|8.95|||Mixed Models Analysis|||||8.95|5.20|<.0001
72589722|NCT03963232|144710920|SUPERIORITY||LS Mean Difference|-1.78|STANDARD_ERROR_OF_MEAN|0.24|<|0.0001|TWO_SIDED|95.0|-2.25|-1.31|||Mixed Models Analysis|||||-1.31|-2.25|<.0001
72589723|NCT03963232|144710921|SUPERIORITY||LS Mean Difference|-1.82|STANDARD_ERROR_OF_MEAN|0.27|<|0.0001|TWO_SIDED|95.0|-2.35|-1.29|||Mixed Models Analysis|||||-1.29|-2.35|<.0001
72589724|NCT03963232|144710922|SUPERIORITY||Odds Ratio (OR)|3.04|||<|0.0001|TWO_SIDED|95.0|1.92|4.81|||Regression, Logistic|||||4.81|1.92|<.0001
72589725|NCT03963232|144710923|SUPERIORITY||LS Mean Difference|-0.89|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-1.15|-0.62|||Mixed Models Analysis|||||-0.62|-1.15|<.0001
72414147|NCT05437510|144337250|SUPERIORITY||Efficacy|32.19||||0.1003|TWO_SIDED|95.0|-7.188|57.545|||Exact method using binomial distribution|||"Statistical analysis for France:~The 2-sided 95% CI for the efficacy was calculated by an exact method assuming a binomial distribution of the number of hospitalizations for all-cause LRTI through day 181 post-dosing/randomization in the nirsevimab group conditional on the total number in both groups accounting for the follow-up time post-dosing/randomization."||57.545|-7.188|0.1003
72414148|NCT05437510|144337250|SUPERIORITY||Efficacy|39.83||||0.0164|TWO_SIDED|95.0|8.449|60.911|||Exact method using binomial distribution|||"Statistical analysis for UK:~The 2-sided 95% CI for the efficacy was calculated by an exact method assuming a binomial distribution of the number of hospitalizations for all-cause LRTI through day 181 post-dosing/randomization in the nirsevimab group conditional on the total number in both groups accounting for the follow-up time post-dosing/randomization."||60.911|8.449|0.0164
72414149|NCT05437510|144337250|SUPERIORITY||Efficacy|64.06||||0.0058|TWO_SIDED|95.0|23.386|84.478|||Exact method using binomial distribution|||"Statistical analysis for Germany:~The 2-sided 95% CI for the efficacy was calculated by an exact method assuming a binomial distribution of the number of hospitalizations for all-cause LRTI through day 181 post-dosing/randomization in the nirsevimab group conditional on the total number in both groups accounting for the follow-up time post-dosing/randomization."||84.478|23.386|0.0058
72589726|NCT03963232|144710924|SUPERIORITY||LS Mean Difference|-18.88|STANDARD_ERROR_OF_MEAN|2.2|<|0.0001|TWO_SIDED|95.0|-23.21|-14.56|||Mixed Models Analysis|||||-14.56|-23.21|<.0001
72589727|NCT03963232|144710925|SUPERIORITY||LS Mean Difference|-19.24|STANDARD_ERROR_OF_MEAN|2.29|<|0.0001|TWO_SIDED|95.0|-23.73|-14.75|||Mixed Models Analysis|||||-14.75|-23.73|<.0001
72589728|NCT03963232|144710926|SUPERIORITY||LS Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.03|<|0.0001|TWO_SIDED|95.0|-0.22|-0.1|||Mixed Models Analysis|||||-0.10|-0.22|<.0001
72589729|NCT03963232|144710927|SUPERIORITY||LS Mean Difference|-0.224|STANDARD_ERROR_OF_MEAN|0.1021||0.0284|TWO_SIDED|95.0|-0.43|-0.02|||ANCOVA|||||-0.02|-0.43|0.0284
72589730|NCT03963232|144710928|SUPERIORITY||LS Mean Difference|-12.429|STANDARD_ERROR_OF_MEAN|3.2484||0.0001|TWO_SIDED|95.0|-18.81|-6.05|||ANCOVA|||||-6.05|-18.81|0.0001
72589731|NCT00356135|144710931|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.91|||<|0.0001||95.0|-19.1|-8.73|||ANOVA|Treatment and study sites are fixed effects and MPA right before the randomization treatment period is a covariate in the model.|Mean Difference is for Prasugrel 10/10 mg arm minus Clopidogrel 75/75 mg arm.|||-8.73|-19.10|<0.0001
72589732|NCT00356135|144710931|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.98|||<|0.0001||95.0|-19.26|-8.71|||ANCOVA|||||-8.71|-19.26|<0.0001
72589733|NCT00356135|144710932|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-2.4||||0.4055|TWO_SIDED|95.0|-8.22|3.35||P-value for 2 Hour (20 uM ADP). Mixed model with actual value at each timepoint as dependent variable, baseline value as covariate, treatment, catagorical timepoint, and time by treatment interaction as fixed effects, and subject as random effect.|Repeated Measures Analysis||Least Squares Mean Difference = Prasugrel 10/10 mg minus Clopidogrel 75/75 mg.|||3.35|-8.22|0.4055
72589734|NCT00356135|144710932|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-23.0|||<|0.0001|TWO_SIDED|95.0|-29.3|-17.51||P-value for 2 Hour (20 uM ADP). Mixed model with actual value at each timepoint as dependent variable, baseline value as covariate, treatment, catagorical timepoint, and time by treatment interaction as fixed effects, and subject as random effect.|Repeated Measures Analysis||Least Squares Mean Difference = Prasugrel 60/10 mg minus Clopidogrel 75/75 mg.|||-17.51|-29.30|<0.0001
72589735|NCT00356135|144710932|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-4.2||||0.068|TWO_SIDED|95.0|-8.82|0.32||P-value for 24 Hour (20 uM ADP). Mixed model with actual value at each timepoint as dependent variable, baseline value as covariate, treatment, catagorical timepoint, and time by treatment interaction as fixed effects, and subject as random effect.|Repeated Measures Analysis||Least Squares Mean Difference = Prasugrel 10/10 mg minus Clopidogrel 75/75 mg.|||0.32|-8.82|0.0680
72589736|NCT00356135|144710932|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-29.0|||<|0.0001|TWO_SIDED|95.0|-33.2|-23.94||P-value for 24 Hour (20 uM ADP). Mixed model with actual value at each timepoint as dependent variable, baseline value as covariate, treatment, catagorical timepoint, and time by treatment interaction as fixed effects, and subject as random effect.|Repeated Measures Analysis||Least Squares Mean Difference = Prasugrel 60/10 mg minus Clopidogrel 75/75 mg.|Comparison of MPA to 20 uM ADP at 24 hours||-23.94|-33.20|<0.0001
72589737|NCT00356135|144710932|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-15.0|||<|0.0001|TWO_SIDED|95.0|-19.96|-9.65||P-value for 1 Week (20 uM ADP). Mixed model with actual value at each timepoint as dependent variable, baseline value as covariate, treatment, catagorical timepoint, and time by treatment interaction as fixed effects, and subject as random effect.|Repeated Measures Analysis||Least Squares Mean Difference = Prasugrel 10/10 mg minus Clopidogrel 75/75 mg.|||-9.65|-19.96|<0.0001
72589738|NCT00356135|144710932|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-15.0|||<|0.0001|TWO_SIDED|95.0|-19.87|-9.32||P-value for 1 Week (20 uM ADP). Mixed model with actual value at each timepoint as dependent variable, baseline value as covariate, treatment, catagorical timepoint, and time by treatment interaction as fixed effects, and subject as random effect.|Repeated Measures Analysis||Least Squares Mean Difference = Prasugrel 60/10 mg minus Clopidogrel 75/75 mg.|||-9.32|-19.87|<0.0001
72589739|NCT00356135|144710932|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-15.0|||<|0.0001|TWO_SIDED|95.0|-20.3|-9.22||P-value for 2 Week (20 uM ADP). Mixed model with actual value at each timepoint as dependent variable, baseline value as covariate, treatment, catagorical timepoint, and time by treatment interaction as fixed effects, and subject as random effect.|Repeated Measures Analysis||Least Squares Mean Difference = Prasugrel 10/10 mg minus Clopidogrel 75/75 mg.|||-9.22|-20.30|<0.0001
72589740|NCT00356135|144710932|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-15.0|||<|0.0001|TWO_SIDED|95.0|-20.59|-9.22||P-value for 2 Week (20 uM ADP). Mixed model with actual value at each timepoint as dependent variable, baseline value as covariate, treatment, catagorical timepoint, and time by treatment interaction as fixed effects, and subject as random effect.|Repeated Measures Analysis||Least Squares Mean Difference = Prasugrel 60/10 mg minus Clopidogrel 75/75 mg.|||-9.22|-20.59|<0.0001
72589741|NCT00356135|144710932|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-1.4||||0.5501|TWO_SIDED|95.0|-5.85|3.14||P-value for 2 Hour (5 uM ADP). Mixed model with actual value at each timepoint as dependent variable, baseline value as covariate, treatment, catagorical timepoint, and time by treatment interaction as fixed effects, and subject as random effect.|Repeated Measures Analysis||Least Squares Mean Difference = Prasugrel 10/10 mg minus Clopidogrel 75/75 mg.|||3.14|-5.85|0.5501
72589742|NCT00356135|144710932|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-17.0|||<|0.0001|TWO_SIDED|95.0|-21.55|-12.37||P-value for 2 Hour (5 uM ADP). Mixed model with actual value at each timepoint as dependent variable, baseline value as covariate, treatment, catagorical timepoint, and time by treatment interaction as fixed effects, and subject as random effect.|Repeated Measures Analysis||Least Squares Mean Difference = Prasugrel 60/10 mg minus Clopidogrel 75/75 mg.|||-12.37|-21.55|<0.0001
72589743|NCT00356135|144710932|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-4.1||||0.0752|TWO_SIDED|95.0|-8.58|0.42||P-value for 24 Hour (5 uM ADP). Mixed model with actual value at each timepoint as dependent variable, baseline value as covariate, treatment, catagorical timepoint, and time by treatment interaction as fixed effects, and subject as random effect.|Repeated Measures Analysis||Least Squares Mean Difference = Prasugrel 10/10 mg minus Clopidogrel 75/75 mg.|||0.42|-8.58|0.0752
72589744|NCT00356135|144710932|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-20.0|||<|0.0001|TWO_SIDED|95.0|-24.81|-15.64||P-value for 24 Hour (5 uM ADP). Mixed model with actual value at each timepoint as dependent variable, baseline value as covariate, treatment, catagorical timepoint, and time by treatment interaction as fixed effects, and subject as random effect.|Repeated Measures Analysis||Least Squares Mean Difference = Prasugrel 60/10 mg minus Clopidogrel 75/75 mg.|||-15.64|-24.81|<0.0001
72589745|NCT00356135|144710932|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-12.0|||<|0.0001|TWO_SIDED|95.0|-17.21|-7.5||P-value for 1 Week (5 uM ADP). Mixed model with actual value at each timepoint as dependent variable, baseline value as covariate, treatment, catagorical timepoint, and time by treatment interaction as fixed effects, and subject as random effect.|Repeated Measures Analysis||Least Squares Mean Difference = Prasugrel 10/10 mg minus Clopidogrel 75/75 mg.|||-7.50|-17.21|<0.0001
72414150|NCT01997398|144337256|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Differences in baseline and 6-month postoperative scores were assessed using a series of repeated measures general linear models with a single within-subjects factor and no between-subjects factors.|Repeated measures general linear models|||||||<0.001
72414151|NCT04389762|144337300|OTHER|||||||0.003|||||||t-test, 2 sided|||||||0.003
72589746|NCT00356135|144710932|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-11.0|||<|0.0001|TWO_SIDED|95.0|-15.79|-5.79||P-value for 1 Week (5 uM ADP). Mixed model with actual value at each timepoint as dependent variable, baseline value as covariate, treatment, catagorical timepoint, and time by treatment interaction as fixed effects, and subject as random effect.|Repeated Measures Analysis||Least Squares Mean Difference = Prasugrel 60/10 mg minus Clopidogrel 75/75 mg.|||-5.79|-15.79|<0.0001
72589747|NCT00356135|144710932|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-13.0|||<|0.0001|TWO_SIDED|95.0|-17.41|-7.72||P-value for 2 Week (5 uM ADP). Mixed model with actual value at each timepoint as dependent variable, baseline value as covariate, treatment, catagorical timepoint, and time by treatment interaction as fixed effects, and subject as random effect.|Repeated Measures Analysis||Least Squares Mean Difference = Prasugrel 10/10 mg minus Clopidogrel 75/75 mg.|||-7.72|-17.41|<0.0001
72589748|NCT00356135|144710932|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-12.0|||<|0.0001|TWO_SIDED|95.0|-16.8|-6.82||P-value for 2 Week (5 uM ADP). Mixed model with actual value at each timepoint as dependent variable, baseline value as covariate, treatment, catagorical timepoint, and time by treatment interaction as fixed effects, and subject as random effect.|Repeated Measures Analysis||Least Squares Mean Difference = Prasugrel 60/10 mg minus Clopidogrel 75/75 mg.|||-6.82|-16.80|<0.0001
72589749|NCT00356135|144710933|SUPERIORITY_OR_OTHER|||||||0.1824|||||||t-test, 2 sided|||The mean of MPA 20 uM ADP at the end of Clopidogrel open label of patients on chronic clopidogrel at the time of qualifying events was compared to the mean MPA of patients not using clopidogrel at this time.||||0.1824
72414152|NCT04389762|144337301|OTHER|||||||0.004|||||||t-test, 2 sided|||||||0.004
72414153|NCT04389762|144337302|OTHER|||||||0.007|||||||t-test, 2 sided|||||||0.007
72414154|NCT04389762|144337303|OTHER|||||||0.04|||||||t-test, 2 sided|||||||0.040
72589750|NCT00356135|144710933|SUPERIORITY_OR_OTHER|||||||0.1101|||||||F-test|||The variance of MPA 20 uM ADP at the end of Clopidogrel open label of patients on chronic clopidogrel at the time of qualifying events was compared to the variance of MPA for patients not using clopidogrel at this time.||||0.1101
72589751|NCT00356135|144710934|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-3.1||||0.3466|TWO_SIDED|95.0|-9.5|3.37||P-value for 2 Hour (20 uM ADP). Mixed model with actual value at each timepoint as dependent variable, baseline value as covariate, treatment, catagorical timepoint, and time by treatment interaction as fixed effects, and subject as random effect.|Repeated Measures Analysis||Least Squares Mean Difference = Prasugrel 10/10 mg minus Clopidogrel 75/75 mg.|||3.37|-9.50|0.3466
72589752|NCT00356135|144710934|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-27.0|||<|0.0001|TWO_SIDED|95.0|-33.4|-20.33||P-value for 2 Hour (20 uM ADP). Mixed model with actual value at each timepoint as dependent variable, baseline value as covariate, treatment, catagorical timepoint, and time by treatment interaction as fixed effects, and subject as random effect.|Repeated Measures Analysis||Least Squares Mean Difference = Prasugrel 60/10 mg minus Clopidogrel 75/75 mg.|||-20.33|-33.40|<0.0001
72589753|NCT00356135|144710934|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-7.3||||0.0127|TWO_SIDED|95.0|-13.04|-1.6||P-value for 24 Hour (20 uM ADP). Mixed model with actual value at each timepoint as dependent variable, baseline value as covariate, treatment, catagorical timepoint, and time by treatment interaction as fixed effects, and subject as random effect.|Repeated Measures Analysis||Least Squares Mean Difference = Prasugrel 10/10 mg minus Clopidogrel 75/75 mg.|||-1.60|-13.04|0.0127
72589754|NCT00356135|144710934|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-34.0|||<|0.0001|TWO_SIDED|95.0|-39.99|-28.42||P-value for 24 Hour (20 uM ADP). Mixed model with actual value at each timepoint as dependent variable, baseline value as covariate, treatment, catagorical timepoint, and time by treatment interaction as fixed effects, and subject as random effect.|Repeated Measures Analysis||Least Squares Mean Difference = Prasugrel 60/10 mg minus Clopidogrel 75/75 mg.|||-28.42|-39.99|<0.0001
72589755|NCT00356135|144710934|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-18.0|||<|0.0001|TWO_SIDED|95.0|-25.58|-11.09||P-value for 1 Week (20 uM ADP). Mixed model with actual value at each timepoint as dependent variable, baseline value as covariate, treatment, catagorical timepoint, and time by treatment interaction as fixed effects, and subject as random effect.|Repeated Measures Analysis||Least Squares Mean Difference = Prasugrel 10/10 mg minus Clopidogrel 75/75 mg.|||-11.09|-25.58|<0.0001
72589756|NCT00356135|144710934|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-20.0|||<|0.0001|TWO_SIDED|95.0|-27.09|-12.26||P-value for 1 Week (20 uM ADP). Mixed model with actual value at each timepoint as dependent variable, baseline value as covariate, treatment, catagorical timepoint, and time by treatment interaction as fixed effects, and subject as random effect.|Repeated Measures Analysis||Least Squares Mean Difference = Prasugrel 60/10 mg minus Clopidogrel 75/75 mg.|||-12.26|-27.09|<0.0001
72589757|NCT00356135|144710934|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-22.0|||<|0.0001|TWO_SIDED|95.0|-28.42|-14.77||P-value for 2 Week (20 uM ADP). Mixed model with actual value at each timepoint as dependent variable, baseline value as covariate, treatment, catagorical timepoint, and time by treatment interaction as fixed effects, and subject as random effect.|Repeated Measures Analysis||Least Squares Mean Difference = Prasugrel 10/10 mg minus Clopidogrel 75/75 mg.|||-14.77|-28.42|<0.0001
72589758|NCT00356135|144710934|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-23.0|||<|0.0001|TWO_SIDED|95.0|-29.61|-15.63||P-value for 2 Week (20 uM ADP). Mixed model with actual value at each timepoint as dependent variable, baseline value as covariate, treatment, catagorical timepoint, and time by treatment interaction as fixed effects, and subject as random effect.|Repeated Measures Analysis||Least Squares Mean Difference = Prasugrel 60/10 mg minus Clopidogrel 75/75 mg.|||-15.63|-29.61|<0.0001
72589759|NCT00356135|144710934|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|1.6||||0.4954|TWO_SIDED|95.0|-3.11|6.38||P-value for 2 Hour (5 uM ADP). Mixed model with actual value at each timepoint as dependent variable, baseline value as covariate, treatment, catagorical timepoint, and time by treatment interaction as fixed effects, and subject as random effect.|Repeated Measures Analysis||Least Squares Mean Difference = Prasugrel 10/10 mg minus Clopidogrel 75/75 mg.|||6.38|-3.11|0.4954
72589760|NCT00356135|144710934|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-11.0|||<|0.0001|TWO_SIDED|95.0|-15.92|-6.24||P-value for 2 Hour (5 uM ADP). Mixed model with actual value at each timepoint as dependent variable, baseline value as covariate, treatment, catagorical timepoint, and time by treatment interaction as fixed effects, and subject as random effect.|Repeated Measures Analysis||Least Squares Mean Difference = Prasugrel 60/10 mg minus Clopidogrel 75/75 mg.|||-6.24|-15.92|<0.0001
72589761|NCT00356135|144710934|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-3.3||||0.1971|TWO_SIDED|95.0|-8.31|1.74||P-value for 24 Hour (5 uM ADP). Mixed model with actual value at each timepoint as dependent variable, baseline value as covariate, treatment, catagorical timepoint, and time by treatment interaction as fixed effects, and subject as random effect.|Repeated Measures Analysis||Least Squares Mean Difference = Prasugrel 10/10 mg minus Clopidogrel 75/75 mg.|||1.74|-8.31|0.1971
72589762|NCT00356135|144710934|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-16.0|||<|0.0001|TWO_SIDED|95.0|-20.98|-10.75||P-value for 24 Hour (5 uM ADP). Mixed model with actual value at each timepoint as dependent variable, baseline value as covariate, treatment, catagorical timepoint, and time by treatment interaction as fixed effects, and subject as random effect.|Repeated Measures Analysis||Least Squares Mean Difference = Prasugrel 60/10 mg minus Clopidogrel 75/75 mg.|||-10.75|-20.98|<0.0001
72589763|NCT00356135|144710934|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-13.0|||<|0.0001|TWO_SIDED|95.0|-18.81|-7.32||P-value for 1 Week (5 uM ADP). Mixed model with actual value at each timepoint as dependent variable, baseline value as covariate, treatment, catagorical timepoint, and time by treatment interaction as fixed effects, and subject as random effect.|Repeated Measures Analysis||Least Squares Mean Difference = Prasugrel 10/10 mg minus Clopidogrel 75/75 mg.|||-7.32|-18.81|<0.0001
72589764|NCT00356135|144710934|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-12.0||||0.0001|TWO_SIDED|95.0|-17.91|-6.09||P-value for 1 Week (5 uM ADP). Mixed model with actual value at each timepoint as dependent variable, baseline value as covariate, treatment, catagorical timepoint, and time by treatment interaction as fixed effects, and subject as random effect.|Repeated Measures Analysis||Least Squares Mean Difference = Prasugrel 60/10 mg minus Clopidogrel 75/75 mg.|||-6.09|-17.91|0.0001
72414155|NCT04389762|144337304|OTHER|||||||0.031|||||||t-test, 2 sided|||||||0.031
72414156|NCT04389762|144337305|OTHER|||||||0.115|||||||t-test, 2 sided|||||||0.115
72589765|NCT00356135|144710934|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-11.0|||<|0.0001|TWO_SIDED|95.0|-15.64|-6.32||P-value for 2 Week (5 uM ADP). Mixed model with actual value at each timepoint as dependent variable, baseline value as covariate, treatment, catagorical timepoint, and time by treatment interaction as fixed effects, and subject as random effect.|Repeated Measures Analysis||Least Squares Mean Difference = Prasugrel 10/10 mg minus Clopidogrel 75/75 mg.|||-6.32|-15.64|<0.0001
72589766|NCT00356135|144710934|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-9.9|||<|0.0001|TWO_SIDED|95.0|-14.67|-5.09||P-value for 2 Week (5 uM ADP). Mixed model with actual value at each timepoint as dependent variable, baseline value as covariate, treatment, catagorical timepoint, and time by treatment interaction as fixed effects, and subject as random effect.|Repeated Measures Analysis||Least Squares Mean Difference = Prasugrel 60/10 mg minus Clopidogrel 75/75 mg.|||-5.09|-14.67|<0.0001
72589767|NCT00356135|144710935|SUPERIORITY_OR_OTHER|||||||0.0005||95.0||||P-value for MPA (20 uM ADP) at 1 week.|Pearson Correlation Coefficient|||||||0.0005
72589768|NCT00356135|144710935|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||P-value for RPA (20 uM ADP) at 1 week.|Pearson Correlation Coefficient|||||||<0.0001
72589769|NCT00356135|144710935|SUPERIORITY_OR_OTHER|||||||0.015||95.0||||P-value for MPA (20 uM ADP) at 1 week.|Pearson Correlation Coefficient|||||||0.0150
72589770|NCT00356135|144710935|SUPERIORITY_OR_OTHER|||||||0.0152||95.0||||P-value for RPA (20 uM ADP) at 1 week.|Pearson Correlation Coefficient|||||||0.0152
72589771|NCT00356135|144710935|SUPERIORITY_OR_OTHER|||||||0.0153||95.0||||P-value for MPA (20 uM ADP) at 1 week.|Pearson Correlation Coefficient|||||||0.0153
72589772|NCT00356135|144710935|SUPERIORITY_OR_OTHER|||||||0.0018||95.0||||P-value for RPA (20 uM ADP) at 1 week.|Pearson Correlation Coefficient|||||||0.0018
72589773|NCT01585324|144710974|SUPERIORITY_OR_OTHER|||||||0.8333|TWO_SIDED||||||ANCOVA|The analysis of covariance (ANCOVA) test for the efficacy of SVR achievement (Yes/No), treatment adjustment and baseline hemoglobin value was used.||||||0.8333
72589774|NCT01585324|144710976|SUPERIORITY_OR_OTHER|||||||0.0867|TWO_SIDED||||||Fisher Exact|||||||0.0867
72589775|NCT01585324|144710978|SUPERIORITY_OR_OTHER|||||||0.6492|TWO_SIDED||||||ANCOVA|||||||0.6492
72589776|NCT01585324|144710980|SUPERIORITY_OR_OTHER|||||||0.0333|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.0333
72589777|NCT03917472|144710989|SUPERIORITY|(1-sided)|LS mean difference|1.1|STANDARD_ERROR_OF_MEAN|0.89||0.099|TWO_SIDED|95.0|-0.6|2.9|||ANOVA|||||2.9|-0.6|0.099
72589778|NCT03917472|144710989|NON_INFERIORITY|(4-letter margin) (1-sided)|||||<|0.001|||||||ANOVA|||||||<0.001
72589779|NCT03917472|144710990|SUPERIORITY|(1-sided); Week 52|LS mean difference|-41.4|STANDARD_ERROR_OF_MEAN|8.94|<|0.001|TWO_SIDED|95.0|-58.9|-23.8|||ANOVA|||||-23.8|-58.9|<0.001
72589780|NCT03917472|144710991|SUPERIORITY|(1-sided) Week 52|Difference - %|20.0|||<|0.001|TWO_SIDED|95.0|12.5|28.6|||Clopper-Pearson exact method.|||||28.6|12.5|<0.001
72589781|NCT03917472|144710998|OTHER|Descriptive|Difference - %|9.3|||||TWO_SIDED|95.0|1.7|17.0|||Clopper-Pearson exact method|||≥ 5 letters gain from baseline or BCVA ≥ 84 letters at Week 52||17.0|1.7|
72589782|NCT03917472|144710998|OTHER|Descriptive|Difference - %|7.7|||||TWO_SIDED|95.0|-1.5|17.0|||Clopper-Pearson exact method|||≥ 10 letters gain from baseline or BCVA ≥ 84 letters at Week 52||17.0|-1.5|
72589783|NCT03917472|144710998|OTHER|Descriptive|Difference - %|5.5|||||TWO_SIDED|95.0|-2.7|14.3|||Clopper-Pearson exact method|||≥ 15 letters gain from baseline or BCVA ≥ 84 letters at Week 52||14.3|-2.7|
72589784|NCT03917472|144710999|OTHER|descriptive; week 12|Difference - %|8.3|||||TWO_SIDED|95.0|0.2|16.5|||Clopper-Pearson exact method|||||16.5|0.2|
72589785|NCT03917472|144710999|OTHER|descriptive; week 24|Difference - %|6.0|||||TWO_SIDED|95.0|-3.0|14.9|||Clopper-Pearson exact method|||||14.9|-3.0|
72589786|NCT03917472|144710999|NON_INFERIORITY|(10% margin); week 52|Difference - %|6.0||||0.002|TWO_SIDED|95.0|-3.9|16.1||(10% margin) (1-sided)|Clopper-Pearson exact method|||||16.1|-3.9|0.002
72589787|NCT03917472|144711000|OTHER|descriptive; week 12|Difference - %|2.0|||||TWO_SIDED|95.0|-2.5|6.6|||Clopper-Pearson exact method|||||6.6|-2.5|
72589788|NCT03917472|144711000|OTHER|descriptive; week 24|Difference - %|2.4|||||TWO_SIDED|95.0|-3.0|7.7|||Clopper-Pearson exact method|||||7.7|-3.0|
72589789|NCT03917472|144711000|OTHER|descriptive; week 52|Difference - %|3.9|||||TWO_SIDED|95.0|-2.0|9.8|||Clopper-Pearson exact method|||||9.8|-2.0|
72589790|NCT02991729|144711021|NON_INFERIORITY|The non-inferiority limit was 1 point on the questionnaire scale.||||||0.929||||||a priori threshold for statistical significance was p\<0.05.|Wilcoxon rank-sum|||||||0.929
72589791|NCT02991729|144711022|SUPERIORITY|||||||0.369|||||||Wilcoxon rank-sum|||Decisional conflict was measured in 2 separate time points in the experimental group - both prior to and following genetic counseling. This analysis compares decisional conflict in the routine care group (after counseling only) to the experimental group following decision aid completion but prior to genetic counseling (first row, second column in above table).||||0.369
72589792|NCT02991729|144711022|SUPERIORITY|||||||0.003|||||||Wilcoxon rank-sum|||Decisional conflict was measured in 2 separate time points in the experimental group - both prior to and following genetic counseling. This analysis compares decisional conflict in the routine care group (after counseling only) to the experimental group following decision aid completion and genetic counseling (second row, second column in above table).||||0.003
72589793|NCT02991729|144711022|SUPERIORITY|||||||0.003|||||||Wilcoxon signed-rank|||Decisional conflict was measured in 2 separate time points in the experimental group - both prior to and following genetic counseling. This analysis compares decisional conflict pre-genetic counseling/post-decision aid to post-genetic counseling.||||0.003
72589794|NCT05225298|144711025|OTHER|||||||0.9||||||A p-value of \< 0.05 would be considered statistically significant|log binomial model|||||||0.90
72589795|NCT05225298|144711026|OTHER|||||||0.94||||||A p-value of \< 0.05 would be considered statistically significant|log binomial model|||||||0.94
72589796|NCT05225298|144711027|OTHER|||||||0.053|||||||log binomial model|||||||0.053
72589797|NCT00748189|144711123|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.57|||<|0.001|TWO_SIDED|95.0|0.45|0.72|||Log Rank||Hazard ratios are obtained using the Pike estimator.|||0.72|0.45|<0.001
72414157|NCT04389762|144337306|OTHER|||||||0.031|||||||t-test, 2 sided|||||||0.031
72414158|NCT03822533|144337308|SUPERIORITY||Mean Difference (Final Values)|0.015||||0.69|TWO_SIDED|95.0|-0.059|0.089|||t-test, 2 sided|||Mean difference using independent samples t-test.||0.089|-0.059|0.69
72589798|NCT00748189|144711126|OTHER||Hazard Ratio (HR)|0.88||||0.363|TWO_SIDED|95.0|0.65|1.17|||Log Rank||hazard ratios are obtained using the Pike estimator. A hazard ratio \<1 indicates a lower risk with O+CHL treatment compared with chlorambucil|||1.17|0.65|0.363
72589799|NCT00748189|144711139|NON_INFERIORITY_OR_EQUIVALENCE|Comparability of dose-normalized chlorambucil Cmax values with ofatumumab in current study and without ofatumumab in prior study|Ratio of Cmax/Dose|0.71|||||TWO_SIDED|90.0|0.53|0.94|||||Ratio of Cmax/Dose is the ratio of dose-normalized chlorambucil Cmax values when given with ofatumumab in the current study and without ofatumumab in the prior study (LEUA1001).|||0.94|0.53|
72589800|NCT00748189|144711139|NON_INFERIORITY_OR_EQUIVALENCE|Comparability of dose-normalized PAAM Cmax values with ofatumumab in current study and without ofatumumab in prior study|Ratio of Cmax/Dose|0.79|||||TWO_SIDED|90.0|0.63|0.99|||||Ratio of Cmax/Dose is the ratio of dose-normalized PAAM Cmax values when given with ofatumumab in the current study and without ofatumumab in the prior study (LEUA1001).|||0.99|0.63|
72589801|NCT00748189|144711140|NON_INFERIORITY_OR_EQUIVALENCE|Comparability of dose-normalized chlorambucil AUC(0-6) values with ofatumumab in current study and without ofatumumab in prior study|Ratio of AUC(0-6)/Dose|1.04|||||TWO_SIDED|90.0|0.77|1.4|||||Ratio of AUC(0-6)/Dose is the ratio of dose-normalized chlorambucil AUC(0-6) values when given with ofatumumab in the current study and without ofatumumab in the prior study (LEUA1001).|||1.40|0.77|
72589802|NCT00748189|144711140|NON_INFERIORITY_OR_EQUIVALENCE|Comparability of dose-normalized chlorambucil AUC(0-inf) values with ofatumumab in current study and without ofatumumab in prior study|Ratio of AUC(0-inf)/Dose|1.11|||||TWO_SIDED|90.0|0.82|1.5|||||Ratio of AUC(0-inf)/Dose is the ratio of dose-normalized chlorambucil AUC(0-inf) values when given with ofatumumab in the current study and without ofatumumab in the prior study (LEUA1001).|||1.50|0.82|
72589803|NCT00748189|144711140|NON_INFERIORITY_OR_EQUIVALENCE|Comparability of dose-normalized PAAM AUC(0-6) values with ofatumumab in current study and without ofatumumab in prior study|Ratio of AUC(0-6)/Dose|0.89|||||TWO_SIDED|90.0|0.72|1.1|||||Ratio of AUC(0-6)/Dose is the ratio of dose-normalized PAAM AUC(0-6) values when given with ofatumumab in the current study and without ofatumumab in the prior study (LEUA1001).|||1.10|0.72|
72589804|NCT03320850|144711148|SUPERIORITY||Least Squares Mean Difference|1.1|STANDARD_ERROR_OF_MEAN|0.635||0.0845|TWO_SIDED|95.0|-0.15|2.35|||ANCOVA||Least square estimates and contrast t-test were used to compare specified treatment groups and were based on ANCOVA model with Baseline value as covariate and treatment group, sex (male, female) as factors.|The null hypothesis is that there is no difference between each (BOTOX® and Hydrogel admixture group) and (placebo and Hydrogel admixture) in the mean change from Baseline in daily average number of UIEs at Week 12.||2.35|-0.15|0.0845
72589805|NCT03320850|144711148|SUPERIORITY||Least Squares Mean Difference|1.83|STANDARD_ERROR_OF_MEAN|0.633||0.0041|TWO_SIDED|95.0|0.59|3.08|||ANCOVA||Least square estimates and contrast t-test were used to compare specified treatment groups and were based on ANCOVA model with Baseline value as covariate and treatment group, sex (male, female) as factors.|The null hypothesis is that there is no difference between each (BOTOX® and Hydrogel admixture group) and (placebo and Hydrogel admixture) in the mean change from Baseline in daily average number of UIEs at Week 12.||3.08|0.59|0.0041
72589806|NCT03320850|144711148|SUPERIORITY||Least Squares Mean Difference|1.19|STANDARD_ERROR_OF_MEAN|0.632||0.06|TWO_SIDED|95.0|-0.05|2.44|||ANCOVA||Least square estimates and contrast t-test were used to compare specified treatment groups and were based on ANCOVA model with Baseline value as covariate and treatment group, sex (male, female) as factors.|The null hypothesis is that there is no difference between each (BOTOX® and Hydrogel admixture group) and (placebo and Hydrogel admixture) in the mean change from Baseline in daily average number of UIEs at Week 12.||2.44|-0.05|0.0600
72589807|NCT03320850|144711148|SUPERIORITY||Least Squares Mean Difference|0.87|STANDARD_ERROR_OF_MEAN|0.631||0.1702|TWO_SIDED|95.0|-0.37|2.11|||ANCOVA||Least square estimates and contrast t-test were used to compare specified treatment groups and were based on ANCOVA model with Baseline value as covariate and treatment group, sex (male, female) as factors.|The null hypothesis is that there is no difference between each (BOTOX® and Hydrogel admixture group) and (placebo and Hydrogel admixture) in the mean change from Baseline in daily average number of UIEs at Week 12.||2.11|-0.37|0.1702
72589808|NCT03320850|144711150|SUPERIORITY||Least Square Mean|0.73|STANDARD_ERROR_OF_MEAN|0.617||0.2361|TWO_SIDED|95.0|-0.48|1.95|||ANCOVA||Least square estimates and contrast t-test were used to compare specified treatment groups and were based on ANCOVA model with Baseline value as covariate and treatment group, sex (male, female) as factors.|||1.95|-0.48|0.2361
72589809|NCT03320850|144711150|SUPERIORITY||Least Square Mean|0.78|STANDARD_ERROR_OF_MEAN|0.608||0.1985|TWO_SIDED|95.0|-0.41|1.98|||ANCOVA||Least square estimates and contrast t-test were used to compare specified treatment groups and were based on ANCOVA model with Baseline value as covariate and treatment group, sex (male, female) as factors.|||1.98|-0.41|0.1985
72589810|NCT03320850|144711150|SUPERIORITY||Least Square Mean|0.64|STANDARD_ERROR_OF_MEAN|0.607||0.2923|TWO_SIDED|95.0|-0.56|1.84|||ANCOVA||Least square estimates and contrast t-test were used to compare specified treatment groups and were based on ANCOVA model with Baseline value as covariate and treatment group, sex (male, female) as factors.|||1.84|-0.56|0.2923
72589811|NCT03320850|144711150|SUPERIORITY||Least Square Mean|0.54|STANDARD_ERROR_OF_MEAN|0.609||0.3769|TWO_SIDED|95.0|-0.66|1.74|||ANCOVA||Least square estimates and contrast t-test were used to compare specified treatment groups and were based on ANCOVA model with Baseline value as covariate and treatment group, sex (male, female) as factors.|||1.74|-0.66|0.3769
72589812|NCT03320850|144711151|SUPERIORITY||Least Square Mean|-7.05|STANDARD_ERROR_OF_MEAN|13.107||0.5911|TWO_SIDED|95.0|-32.87|18.77|||ANCOVA||Least square estimates and contrast t-test were used to compare specified treatment groups and were based on ANCOVA model with Baseline value as covariate and treatment group, sex (male, female) as factors.|||18.77|-32.87|0.5911
72589813|NCT03320850|144711151|SUPERIORITY||Least Square Mean|-8.0|STANDARD_ERROR_OF_MEAN|12.956||0.5375|TWO_SIDED|95.0|-33.52|17.52|||ANCOVA||Least square estimates and contrast t-test were used to compare specified treatment groups and were based on ANCOVA model with Baseline value as covariate and treatment group, sex (male, female) as factors.|||17.52|-33.52|0.5375
72589814|NCT03320850|144711151|SUPERIORITY||Least Square Mean|-1.33|STANDARD_ERROR_OF_MEAN|12.764||0.9173|TWO_SIDED|95.0|-26.47|23.81|||ANCOVA||Least square estimates and contrast t-test were used to compare specified treatment groups and were based on ANCOVA model with Baseline value as covariate and treatment group, sex (male, female) as factors.|||23.81|-26.47|0.9173
72589815|NCT03320850|144711151|SUPERIORITY||Least Square Mean|9.33|STANDARD_ERROR_OF_MEAN|12.981||0.473|TWO_SIDED|95.0|-16.24|34.9|||ANCOVA||Least square estimates and contrast t-test were used to compare specified treatment groups and were based on ANCOVA model with Baseline value as covariate and treatment group, sex (male, female) as factors.|||34.90|-16.24|0.4730
72589816|NCT01424514|144711157|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.12|STANDARD_ERROR_OF_MEAN|0.24|||TWO_SIDED|95.0|-0.6|0.36||||||Placebo vs SB-705498 12 mg for 1 h in WM 0-60 TSS||0.36|-0.60|
72589817|NCT01424514|144711157|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.03|STANDARD_ERROR_OF_MEAN|0.24|||TWO_SIDED|95.0|-0.45|0.51||||||Placebo vs SB-705498 12 mg for 24 h in WM 0-60 TSS||0.51|-0.45|
72589818|NCT01424514|144711157|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.03|STANDARD_ERROR_OF_MEAN|0.27|||TWO_SIDED|95.0|-0.58|0.51||||||Placebo vs SB-705498 12 mg for 1 h in Maximum TSS||0.51|-0.58|
72589819|NCT01424514|144711157|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.11|STANDARD_ERROR_OF_MEAN|0.3|||TWO_SIDED|95.0|-0.51|0.72||||||Placebo vs SB-705498 12 mg for 24 h in Maximum TSS||0.72|-0.51|
72589820|NCT01424514|144711159|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.12|STANDARD_ERROR_OF_MEAN|0.21|||TWO_SIDED|95.0|-0.3|0.54||||||Placebo vs SB-705498 12 mg for WM 0-60 TSS||0.54|-0.30|
72589821|NCT01424514|144711159|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.09|STANDARD_ERROR_OF_MEAN|0.24|||TWO_SIDED|95.0|-0.39|0.57||||||Placebo vs SB-705498 12 mg for Maximum TSS||0.57|-0.39|
72589822|NCT01424514|144711163|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.03|STANDARD_ERROR_OF_MEAN|0.05|||TWO_SIDED|95.0|-0.14|0.08||||||Placebo vs SB-705498 12 mg for Day 1, 1 h in WM 0-60 sneezing||0.08|-0.14|
72589823|NCT01424514|144711163|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.05|||TWO_SIDED|95.0|-0.13|0.09||||||Placebo vs SB-705498 12 mg for Day 14, 1 h in WM 0-60 sneezing||0.09|-0.13|
72589824|NCT01424514|144711163|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.08|||TWO_SIDED|95.0|-0.2|0.11||||||Placebo vs SB-705498 12 mg for Day 14, 24 h in WM 0-60 sneezing||0.11|-0.20|
72589825|NCT01424514|144711163|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.07|STANDARD_ERROR_OF_MEAN|0.1|||TWO_SIDED|95.0|-0.28|0.14||||||Placebo vs SB-705498 12 mg for Day 1, 1 h in Maximum sneezing||0.14|-0.28|
72589826|NCT01424514|144711163|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.07|||TWO_SIDED|95.0|-0.15|0.13||||||Placebo vs SB-705498 12 mg for Day 14, 1 h in Maximum sneezing||0.13|-0.15|
72589827|NCT01424514|144711163|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.09|||TWO_SIDED|95.0|-0.2|0.16||||||Placebo vs SB-705498 12 mg for Day 1, 24 h in Maximum sneezing||0.16|-0.20|
72589828|NCT01424514|144711164|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.026|||TWO_SIDED|95.0|-0.03|0.07||||||Placebo vs SB-705498 12 mg for Day 1, 2 h in AR||0.07|-0.03|
72589829|NCT01424514|144711164|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.08|STANDARD_ERROR_OF_MEAN|0.027|||TWO_SIDED|95.0|-0.13|-0.02||||||Placebo vs SB-705498 12 mg for Day 14, 2 h in AR||-0.02|-0.13|
72589830|NCT01424514|144711164|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.031|||TWO_SIDED|95.0|-0.04|0.08||||||Placebo vs SB-705498 12 mg for Day 14, 25 h in AR||0.08|-0.04|
72589831|NCT01424514|144711165|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.15|||TWO_SIDED|95.0|-0.36|0.26||||||Placebo vs SB-705498 12 mg for Day 14 in AR||0.26|-0.36|
72589832|NCT01424514|144711166|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.27|STANDARD_ERROR_OF_MEAN|0.16|||TWO_SIDED|95.0|-0.06|0.6||||||Placebo vs SB-705498 12 mg for Day 1, 1 h in WM 0-60 TOSS||0.60|-0.06|
72589833|NCT01424514|144711166|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.21|||TWO_SIDED|95.0|-0.32|0.53||||||Placebo vs SB-705498 12 mg for Day 14, 1 h in WM 0-60 TOSS||0.53|-0.32|
72589834|NCT01424514|144711166|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.21|STANDARD_ERROR_OF_MEAN|0.21|||TWO_SIDED|95.0|-0.22|0.63||||||Placebo vs SB-705498 12 mg for Day 14, 24 h in WM 0-60 TOSS||0.63|-0.22|
72589835|NCT01424514|144711166|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.19|STANDARD_ERROR_OF_MEAN|0.24|||TWO_SIDED|95.0|-0.3|0.68||||||Placebo vs SB-705498 12 mg for Day 1, 1 h in Maximum TOSS||0.68|-0.30|
72589836|NCT01424514|144711166|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.26|STANDARD_ERROR_OF_MEAN|0.3|||TWO_SIDED|95.0|-0.34|0.86||||||Placebo vs SB-705498 12 mg for Day 14, 1 h in Maximum TOSS||0.86|-0.34|
72589837|NCT01424514|144711166|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.29|STANDARD_ERROR_OF_MEAN|0.22|||TWO_SIDED|95.0|-0.15|0.73||||||Placebo vs SB-705498 12 mg for Day 14, 24 h in Maximum TOSS||0.73|-0.15|
72589838|NCT02653170|144711183|SUPERIORITY||difference-in-differences (DID) p-value|0.025||||0.025|TWO_SIDED|||||P-value represents the test of the interaction term for a difference-in-differences (DID) model \[i.e., 2 degree freedom test of the interaction between intervention group\*time\]|Mixed Models Analysis|PROC MIXED MODEL including main effects of intervention group (UC, SWSCM, SWSCM+VSSP website) and time (7-day and 90-day) plus the interaction term|The DID estimates contrasting the 90-day minus 7-day differences in each group are as follows: SWSCM vs Usual Care = 0.970 (p=0.335), SWSCM+VSSP vs Usual Care = 3.370 (p\<0.001), SWSCM+VSSP vs SWSCM = 2.400 (p=0.016)|Data were analyzed as the change over time between treatment groups (i.e., 90-day least square mean minus 7-day least square mean) using a difference-in-differences (DID) analysis that involves a group \* time interaction term.||||0.025
72589839|NCT02653170|144711184|SUPERIORITY||difference-in-differences (DID) p-value|0.562||||0.562|TWO_SIDED|||||P-value represents the test of the interaction term for a difference-in-differences (DID) model \[i.e., 2 degree freedom test of the interaction between intervention group\*time\]|Mixed Models Analysis|PROC MIXED MODEL including main effects of intervention group (UC, SWSCM, SWSCM+VSSP website) and time (7-day and 90-day) plus the interaction term|The DID estimates contrasting the 90-day minus 7-day differences in each group are as follows: SWSCM vs Usual Care = -1.064 (p=0.422), SWSCM+VSSP vs Usual Care = 0.258 (p=0.844), SWSCM+VSSP vs SWSCM = 1.322 (p=0.309)|Data were analyzed as the change over time between treatment groups (i.e., 90-day least square mean minus 7-day least square mean) using a difference-in-differences (DID) analysis that involves a group \* time interaction term.||||0.562
72414159|NCT03822533|144337308|SUPERIORITY||Mean Difference (Final Values)|-0.015|||||TWO_SIDED|95.0|-0.093|0.063||The linear regression analysis was needed to calculate the incremental cost efficiency ratio (ICER). The p-value from this test was not relevant for the ICER calculation.|Regression, Linear|First step in a cost-efficiency analysis||Presenting β-values from linear regression analysis for group variable adjusted for baseline differences in EQ-5D-3L-index. The results from this analysis were used to calculate incremental cost-effectiveness ratio (mean difference in costs divided by mean difference in QALYs).||0.063|-0.093|
72589840|NCT02653170|144711185|SUPERIORITY|||||||0.789||||||P-value represents the test of the interaction term for a difference-in-differences (DID) model \[i.e., 2 degree freedom test of the interaction between intervention group\*time\]|Mixed Models Analysis|||Data were analyzed as the change over time between treatment groups (i.e., 90-day least square mean minus 7-day least square mean) using a difference-in-differences (DID) analysis that involves a group \* time interaction term.||||0.789
72589841|NCT02653170|144711186|SUPERIORITY||difference-in-differences (DID) p-value|0.042||||0.042|TWO_SIDED|||||P-value represents the test of the interaction term for a difference-in-differences (DID) model \[i.e., 2 degree freedom test of the interaction between intervention group\*time\]|Mixed Models Analysis||The DID estimates contrasting the 90-day minus 7-day differences in each group are as follows: SWSCM vs Usual Care = -1.651 (p=0.558), SWSCM+VSSP vs Usual Care = 5.023 (p=0.073), SWSCM+VSSP vs SWSCM = 6.674 (p=0.016)|Data were analyzed as the change over time between treatment groups (i.e., 90-day least square mean minus 7-day least square mean) using a difference-in-differences (DID) analysis that involves a group \* time interaction term.||||0.042
72589842|NCT02653170|144711187|SUPERIORITY|||||||0.993||||||P-value represents the test of the interaction term for a difference-in-differences (DID) model \[i.e., 2 degree freedom test of the interaction between intervention group\*time\]|Mixed Models Analysis|||Data were analyzed as the change over time between treatment groups (i.e., 90-day least square mean minus 7-day least square mean) using a difference-in-differences (DID) analysis that involves a group \* time interaction term.||||0.993
72589843|NCT00090220|144711215|SUPERIORITY_OR_OTHER||Percent Relative Risk Reduction|88.7||||||95.0|78.1|94.8|||||Confidence Interval based on binomial tail probabilities and not from a dispersion parameter.|||94.8|78.1|
72589844|NCT00090220|144711241|SUPERIORITY_OR_OTHER||Percent Relative Risk Reduction|94.8||||||95.0|79.9|99.4|||||Confidence Interval based on binomial tail probabilities and not from a dispersion parameter.|||99.4|79.9|
72589845|NCT00090220|144711249|SUPERIORITY_OR_OTHER||Percent Relative Risk Reduction|84.7||||||95.0|67.5|93.7|||||Confidence Interval based on binomial tail probabilities and not from a dispersion parameter.|||93.7|67.5|
72589846|NCT00537316|144711264|SUPERIORITY_OR_OTHER|||||||0.032||95.0|||||Chi-squared|||||||0.032
72589847|NCT03452488|144711290|SUPERIORITY|||||||0.2437|||||||Mixed Models Analysis|||Analysis of data collected from baseline to 6 months, or baseline to 9 months due to pandemic.||||0.2437
72589848|NCT03452488|144711290|SUPERIORITY|||||||0.2|||||||Mixed Models Analysis|||Analysis of data collected from baseline to 6 months, or baseline to 9 months due to pandemic||||0.2000
72589849|NCT03452488|144711290|SUPERIORITY|||||||0.324|TWO_SIDED|95.0|||||Adjusted Bayesian Imputation|||Analysis of data collected from baseline to 6 months, or baseline to 9 months due to pandemic based on adjusted Bayesian Imputation||||0.3240
72589850|NCT03452488|144711290|SUPERIORITY|Gait Speed Based on Adjusted Bayesian Imputation||||||0.5123|||||||Adjusted Bayesian Imputation|||Analysis of data collected from baseline to 6 months, or baseline to 9 months due to pandemic based on adjusted Bayesian Imputation||||0.5123
72589851|NCT03452488|144711290|SUPERIORITY|||||||0.692|||||||Mixed Models Analysis|||Analysis of data collected from baseline to 6 months, or baseline to 9 months due to pandemic based on MI and Adjusted Bayesian Imputation||||0.6920
72589852|NCT03452488|144711290|SUPERIORITY|||||||0.085|TWO_SIDED|95.0|||||Mixed Models Analysis|||Analysis of data collected from baseline to 6 months, or baseline to 9 months due to pandemic based on MI and Adjusted Bayesian Imputation||||0.0850
72589853|NCT03452488|144711291|SUPERIORITY|||||||0.9408|||||||Mixed Models Analysis|||Analysis of data collected from baseline to 6 months, or baseline to 9 months due to pandemic in Physical Function Domain (PF-10) Sub-score based on Mixed Model Analysis||||0.9408
72589854|NCT03452488|144711291|SUPERIORITY|||||||0.9485|TWO_SIDED|95.0|||||Mixed Models Analysis|||Analysis of data collected from baseline to 6 months, or baseline to 9 months due to pandemic in Physical Function Domain (PF-10) Sub-score based on Mixed Model Analysis||||0.9485
72589855|NCT03452488|144711291|SUPERIORITY|||||||0.9848|||||||Mixed Models Analysis|||Analysis of data collected from baseline to 6 months, or baseline to 9 months due to pandemic in Physical Function Domain (PF-10) Sub-Score Based on Adjusted Bayesian Imputation||||0.9848
72589856|NCT03452488|144711291|SUPERIORITY|||||||0.5017|||||||Mixed Models Analysis|||Analysis of data collected from baseline to 6 months, or baseline to 9 months due to pandemic in Physical Function Domain (PF-10) Sub-Score Based on Adjusted Bayesian Imputation||||0.5017
72589857|NCT03452488|144711292|SUPERIORITY|||||||0.52|||||||ANCOVA|||Analysis of data collected from baseline to 6 months, or baseline to 9 months due to pandemic in Handgrip Strength Test (dominant hand)||||0.5200
72589858|NCT03452488|144711292|SUPERIORITY|||||||0.3577|||||||ANCOVA|||Analysis of data collected from baseline to 6 months, or baseline to 9 months due to pandemic in Handgrip Strength Test (dominant hand)||||0.3577
72414160|NCT03822533|144337309|SUPERIORITY||Mean Difference (Final Values)|-364.0||||0.17|TWO_SIDED|95.0|-891.0|164.0|||t-test, 2 sided|||Independent-samples t-test. Dependent variable cost items, independent variable group (physiotherapist or physician assessment)||164|-891|0.17
72414161|NCT03822533|144337309|SUPERIORITY||Mean Difference (Final Values)|-364.0|||||TWO_SIDED|95.0|-870.0|143.0||The linear regression analysis was needed to calculate the incremental cost efficiency ratio (ICER). The p-value from this test was not relevant for the ICER calculation.|Regression, Linear|First step in a cost-efficiency analysis||||143|-870|
72414162|NCT03822533|144337310|SUPERIORITY||Mean Difference (Final Values)|-233.0||||0.23|TWO_SIDED|95.0|-616.0|150.0|||t-test, 2 sided|||Independent-samples t-test. Dependent variable cost items, independent variable group (physiotherapist or physician assessment)||150|-616|0.23
72589859|NCT03452488|144711292|SUPERIORITY|||||||0.9237|||||||ANCOVA|||Analysis of data collected from baseline to 6 months, or baseline to 9 months due to pandemic in Handgrip Strength Test at Month 6 Based on Multiple Imputation (dominant hand)||||0.9237
72589860|NCT03452488|144711292|SUPERIORITY|||||||0.7629|||||||ANCOVA|||Analysis of data collected from baseline to 6 months, or baseline to 9 months due to pandemic in Handgrip Strength Test at Month 6 Based on Multiple Imputation (dominant hand)||||0.7629
72589861|NCT03452488|144711292|SUPERIORITY|||||||0.5695|||||||ANCOVA|||Analysis of data collected from baseline to 6 months, or baseline to 9 months due to pandemic in Change from Baseline in Handgrip Strength Test (left hand)||||0.5695
72589862|NCT03452488|144711292|SUPERIORITY|||||||0.3523|||||||ANCOVA|||Analysis of data collected from baseline to 6 months, or baseline to 9 months due to pandemic in Handgrip Strength Test (Left hand)||||0.3523
72589863|NCT03452488|144711292|SUPERIORITY|||||||0.5652|||||||ANCOVA|||Analysis of data collected from baseline to 6 months, or baseline to 9 months due to pandemic in Handgrip Strength Test (Right hand)||||0.5652
72589864|NCT03452488|144711292|SUPERIORITY|||||||0.2472|||||||ANCOVA|||Analysis of data collected from baseline to 6 months, or baseline to 9 months due to pandemic in Handgrip Strength Test (Right hand)||||0.2472
72589865|NCT03452488|144711293|SUPERIORITY|||||||0.9859||||||Statistical Analysis of Change from Baseline in ALM|ANCOVA|||||||0.9859
72589866|NCT03452488|144711293|SUPERIORITY|||||||0.404|||||||ANCOVA|||Statistical Analysis of Change from Baseline in ALM||||0.4040
72589867|NCT03452488|144711294|SUPERIORITY|||||||0.1219|||||||Regression, Logistic|||||||0.1219
72589868|NCT03452488|144711294|SUPERIORITY|||||||0.052|TWO_SIDED|95.0|||||Regression, Logistic|||||||0.0520
72589869|NCT03452488|144711295|SUPERIORITY|||||||0.8917|||||||ANCOVA|||||||0.8917
72589870|NCT03452488|144711295|SUPERIORITY||Mean Difference (Final Values)|-4.999|STANDARD_ERROR_OF_MEAN|10.2172||0.6317|TWO_SIDED|95.0|-26.777|16.778|||ANCOVA|||||16.778|-26.777|0.6317
72589871|NCT03452488|144711296|SUPERIORITY|||||||0.3762|||||||Mixed Models Analysis|||||||0.3762
72589872|NCT03452488|144711296|SUPERIORITY|||||||0.0543|||||||Mixed Models Analysis|||||||0.0543
72589873|NCT03452488|144711297|SUPERIORITY|||||||0.8824|||||||ANCOVA|||||||0.8824
72589874|NCT03452488|144711297|SUPERIORITY|||||||0.1578|||||||ANCOVA|||||||0.1578
72589875|NCT03452488|144711298|SUPERIORITY|||||||0.0511|||||||ANCOVA|||||||0.0511
72589876|NCT03452488|144711298|SUPERIORITY|||||||0.2771|||||||ANCOVA|||||||0.2771
72589877|NCT03452488|144711299|SUPERIORITY|||||||0.8084|||||||Mixed Models Analysis|||||||0.8084
72589878|NCT03452488|144711299|SUPERIORITY|||||||0.7266|||||||Mixed Models Analysis|||||||0.7266
72589879|NCT03452488|144711300|SUPERIORITY|||||||0.2312|||||||Mixed Models Analysis|||||||0.2312
72589880|NCT03452488|144711300|SUPERIORITY|||||||0.2701|||||||Mixed Models Analysis|||||||0.2701
72414163|NCT03822533|144337310|SUPERIORITY||Mean Difference (Final Values)|-233.0|||||TWO_SIDED|95.0|-605.0|139.0||The linear regression analysis was needed to calculate the incremental cost efficiency ratio (ICER). The p-value from this test was not relevant for the ICER calculation.|Regression, Linear|First step in a cost-efficiency analysis.||Linear regression analysis. The results from this analysis were used to calculate incremental cost-effectiveness ratio (mean difference in costs divided by mean difference in QALYs).||139|-605|
72414164|NCT03822533|144337313|SUPERIORITY||Mean Difference (Final Values)|48.0||||0.72|TWO_SIDED|95.0|-219.0|314.0|||t-test, 2 sided|||||314|-219|0.72
72414165|NCT03822533|144337314|SUPERIORITY||Mean Difference (Final Values)|-178.0|||<|0.01|TWO_SIDED|95.0|-239.0|118.0|||t-test, 2 sided|||||118|-239|<0.01
72414166|NCT03822533|144337315|SUPERIORITY||Mean Difference (Final Values)|-24.0||||0.01|TWO_SIDED|95.0|-42.0|6.2|||t-test, 2 sided|||||6.2|-42|0.01
72414167|NCT03822533|144337316|SUPERIORITY||Mean Difference (Final Values)|-12.0||||0.62|TWO_SIDED|95.0|-59.0|36.0|||t-test, 2 sided|||||36|-59|0.62
72589881|NCT03452488|144711301|SUPERIORITY|||||||0.8934|||||||ANCOVA|||||||0.8934
72589882|NCT03452488|144711301|SUPERIORITY|||||||0.3526|||||||ANCOVA|||||||0.3526
72589883|NCT00281632|144711321|SUPERIORITY_OR_OTHER||Reponse rate|31.0||||||95.0|16.3|48.1|||||50% Response Rate (Normalized and Non-Normalized)|||48.1|16.3|
72589884|NCT00281632|144711325|SUPERIORITY_OR_OTHER||Response rate|17.6||||||95.0|3.8|43.4|||||Response rate (CR+PR)|||43.4|3.8|
72589885|NCT00281632|144711325|SUPERIORITY_OR_OTHER||Response rate|21.1||||||95.0|6.1|45.6|||||Response rate (CR+PR)|||45.6|6.1|
72589886|NCT00281632|144711325|SUPERIORITY_OR_OTHER||Response rate|19.4||||||95.0|8.2|36.0|||||Response rate (CR+PR)|||36.0|8.2|
72589887|NCT01945970|144711345|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.34||||0.36|TWO_SIDED|95.0|-1.09|0.4|||Mixed Models Analysis|Subject as random factor, baseline same period and mean baseline in both periods as covariates, and treatment, operator, and period as fixed effects.|Effect of black tea adjusted for placebo|||0.40|-1.09|0.36
72589888|NCT01945970|144711346|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.52||||0.18|TWO_SIDED|95.0|-0.24|1.28|||Mixed Models Analysis|Subject as random factor, baseline same period and mean baseline in both periods as covariates, and treatment, operator, and period as fixed effects.|Effect of black tea adjusted for placebo|||1.28|-0.24|0.18
72589889|NCT01945970|144711347|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.89||||0.014|TWO_SIDED|95.0|-1.59|-0.19|||Mixed Models Analysis|Subject as random factor, baseline same period and mean baseline in both periods as covariates, and treatment, operator, and period as fixed effects.|Effect of black tea adjusted for placebo|||-0.19|-1.59|0.014
72589890|NCT01945970|144711348|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.49||||0.22|TWO_SIDED|95.0|-1.3|0.31|||Mixed Models Analysis|Subject as random factor, baseline same period and mean baseline in both periods as covariates, and treatment, operator, and period as fixed effects.|Effect of positive control adjusted for placebo|||0.31|-1.30|0.22
72589891|NCT01945970|144711349|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.71||||0.09|TWO_SIDED|95.0|-0.11|1.53|||Mixed Models Analysis|Subject as random factor, baseline same period and mean baseline in both periods as covariates, and treatment, operator, and period as fixed effects.|Effect of positive control adjusted for placebo|||1.53|-0.11|0.09
72589892|NCT01945970|144711350|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.38||||0.32|TWO_SIDED|95.0|-1.13|0.37|||Mixed Models Analysis|Subject as random factor, baseline same period and mean baseline in both periods as covariates, and treatment, operator, and period as fixed effects.|Effect of positive control adjusted for placebo|||0.37|-1.13|0.32
72589893|NCT01945970|144711351|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.89||||0.14|TWO_SIDED|95.0|-0.61|4.39|||Mixed Models Analysis|Subject as random factor and treatment and period as fixed effects.|Effect of black tea adjusted for placebo|||4.39|-0.61|0.14
72589894|NCT01945970|144711352|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4||||0.69|TWO_SIDED|95.0|-2.41|1.62|||Mixed Models Analysis|Subject as random factor and treatment and period as fixed effects.|Effect of black tea adjusted for placebo|||1.62|-2.41|0.69
72589895|NCT01945970|144711353|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.44||||0.72|TWO_SIDED|95.0|-2.06|2.95|||Mixed Models Analysis|Subject as random factor and treatment and period as fixed effects|Effect of positive control adjusted for placebo|||2.95|-2.06|0.72
72589896|NCT01945970|144711354|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.86||||0.39|TWO_SIDED|95.0|-1.15|2.88|||Mixed Models Analysis|Subject as random factor and treatment and period as fixed effects|Effect of positive control adjusted for placebo|||2.88|-1.15|0.39
72589897|NCT01945970|144711355|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.25||||0.74|TWO_SIDED|95.0|-1.75|1.24|||Mixed Models Analysis|Subject as random factor, baseline same period and mean baseline in both periods as covariates, and treatment, operator, and period as fixed effects.|Effect of black tea adjusted for placebo|||1.24|-1.75|0.74
72589898|NCT01945970|144711356|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.62||||0.41|TWO_SIDED|95.0|-2.12|0.88|||Mixed Models Analysis|Subject as random factor, baseline same period and mean baseline in both periods as covariates, and treatment, operator, and period as fixed effects.|Effect of black tea adjusted for placebo|||0.88|-2.12|0.41
72589899|NCT01945970|144711357|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.22||||0.74|TWO_SIDED|95.0|-1.11|1.54|||Mixed Models Analysis|Subject as random factor, baseline same period and mean baseline in both periods as covariates, and treatment, operator, and period as fixed effects.|Effect of black tea adjusted for placebo|Subject as random factor, baseline same period and mean baseline in both periods as covariates, and treatment, operator, and period as fixed effects||1.54|-1.11|0.74
72589900|NCT01945970|144711358|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.33||||0.66|TWO_SIDED|95.0|-1.84|1.17|||Mixed Models Analysis|Subject as random factor, baseline same period and mean baseline in both periods as covariates, and treatment, operator, and period as fixed effects.|Effect of positive control adjusted for placebo|||1.17|-1.84|0.66
72589901|NCT01945970|144711359|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.2||||0.11|TWO_SIDED|95.0|-2.7|0.3|||Mixed Models Analysis|Subject as random factor, baseline same period and mean baseline in both periods as covariates, and treatment, operator, and period as fixed effects.|Effect of positive control adjusted for placebo|||0.30|-2.70|0.11
72589902|NCT01945970|144711360|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.4||||0.55|TWO_SIDED|95.0|-0.93|1.73|||Mixed Models Analysis||Effect of positive control adjusted for placebo|||1.73|-0.93|0.55
72589903|NCT00782184|144711361|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|8.4|||<|0.001|TWO_SIDED|95.0|3.4|21.0|||Regression, Logistic|||COMPARISON BETWEEN GROUPS FOR NUMBER OF PARTICIPANTS REACHING LDL-C GOAL OF \<70 MG/DL||21.0|3.4|<0.001
72589904|NCT00782184|144711362|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Means|-15.0|||<|0.001|TWO_SIDED|95.0|-21.15|-8.84|||Longitudinal Data Analysis (LDA) Model|||||-8.84|-21.15|<0.001
72589905|NCT00782184|144711363|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|6.7|||<|0.001|TWO_SIDED|95.0|3.3|13.9|||Regression, Logistic|||||13.9|3.3|<0.001
72589906|NCT00782184|144711364|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|3.5|||<|0.001|TWO_SIDED|95.0|2.0|6.0|||Regression, Logistic|||||6.0|2.0|<0.001
72589907|NCT00782184|144711365|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Means|-8.24|||<|0.001|TWO_SIDED|95.0|-12.5|-3.97|||LDA Model|||||-3.97|-12.50|<0.001
72589908|NCT00782184|144711366|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Means|2.13||||0.593|TWO_SIDED|95.0|-5.67|9.93|||LDA Model|||||9.93|-5.67|0.593
72589909|NCT00782184|144711367|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Means|2.48||||0.211|TWO_SIDED|95.0|-1.41|6.37|||LDA Model|||||6.37|-1.41|0.211
72589910|NCT00782184|144711368|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Means|-11.62|||<|0.001|TWO_SIDED|95.0|-17.32|-5.92|||LDA Model|||||-5.92|-17.32|<0.001
72589911|NCT00782184|144711369|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Means|-16.1|||<|0.001|TWO_SIDED|95.0|-22.77|-9.44|||LDA Model|||||-9.44|-22.77|<0.001
72589912|NCT00782184|144711370|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Means|-10.02|||<|0.001|TWO_SIDED|95.0|-14.96|-5.08|||LDA Model|||||-5.08|-14.96|<0.001
72414168|NCT03822533|144337317|SUPERIORITY||Mean Difference (Final Values)|1.2||||0.87|TWO_SIDED|95.0|-13.0|15.0|||t-test, 2 sided|||||15|-13|0.87
72414169|NCT03822533|144337318|SUPERIORITY||Mean Difference (Final Values)|-254.0||||0.27|TWO_SIDED|95.0|-728.0|220.0|||t-test, 2 sided|||||220|-728|0.27
72589913|NCT00782184|144711371|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Means|-13.21|||<|0.001|TWO_SIDED|95.0|-19.83|-6.59|||LDA Model|||||-6.59|-19.83|<0.001
72589914|NCT00782184|144711372|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Means|-7.69||||0.002|TWO_SIDED|95.0|-12.5|-2.88|||LDA Model|||||-2.88|-12.50|0.002
72589915|NCT00782184|144711373|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Means|5.25|||<|0.001|TWO_SIDED|95.0|2.44|8.06|||LDA Model|||||8.06|2.44|<0.001
72589916|NCT00782184|144711374|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Means|-12.91|||<|0.001|TWO_SIDED|95.0|-18.31|-7.52|||LDA Model|||||-7.52|-18.31|<0.001
72589917|NCT00782184|144711375|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Means|2.68||||0.785|TWO_SIDED|95.0|-16.5|21.86|||LDA Model|||||21.86|-16.50|0.785
72589918|NCT01369108|144711381|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8|||||||ANOVA|||null hypothesis no difference in anatomic form||||0.8
72589919|NCT01369108|144711381|SUPERIORITY_OR_OTHER_LEGACY|||||||0.89|||||||ANOVA|||null hypothesis no difference in margin adaptation||||0.89
72589920|NCT01369108|144711381|SUPERIORITY_OR_OTHER_LEGACY|||||||0.79|||||||ANOVA|||null hypothesis no difference in margin discoloration||||0.79
72589921|NCT01369108|144711381|SUPERIORITY_OR_OTHER_LEGACY|||||||0.18|||||||ANOVA|||null hypothesis no difference in surface integrity||||0.18
72589922|NCT01369108|144711381|SUPERIORITY_OR_OTHER_LEGACY|||||||0.66|||||||ANOVA|||null hypothesis no difference in secondary caries||||0.66
72589923|NCT01369108|144711382|SUPERIORITY_OR_OTHER_LEGACY|||||||0.522|||||||ANOVA|||null hypothesis no difference in sensitivity to cold||||0.522
72589924|NCT01369108|144711382|SUPERIORITY_OR_OTHER_LEGACY|||||||0.449|||||||Chi-squared|||null hypothesis no difference in biting pressure||||.449
72589925|NCT04143594|144711387|SUPERIORITY||Difference in percentage|-2.6||||0.7178|TWO_SIDED|95.0|-18.4|13.2||P-value was from the Cochran-Mantel-Haenszel (CMH) tests stratified by baseline HIV-1 RNA stratum (≤ 100,000 vs \> 100,000 copies/mL).|Cochran-Mantel-Haenszel||The difference in percentage of participants between LEN-containing and the B/F/TAF groups, and its 95% confidence interval (CI) were calculated based on the MH proportions adjusted by baseline HIV-1 RNA stratum (≤ 100,000 vs \> 100,000 copies/mL).|||13.2|-18.4|0.7178
72589926|NCT04143594|144711387|SUPERIORITY||Difference in percentage|-7.1||||0.39|TWO_SIDED|95.0|-23.4|9.3||P-value was from the CMH tests stratified by baseline HIV-1 RNA stratum (\<= 100,000 vs. \> 100,000 copies/mL).|Cochran-Mantel-Haenszel||The difference in percentage of participants between LEN-containing treatment groups and the B/F/TAF group, and its 95% CI were calculated based on the MH proportions adjusted by baseline HIV-1 RNA stratum (≤ 100,000 vs \> 100,000 copies/mL).|||9.3|-23.4|0.3900
72589927|NCT04143594|144711387|SUPERIORITY||Difference in percentage|-7.2||||0.3797|TWO_SIDED|95.0|-23.5|9.1||P-value was from the CMH tests stratified by baseline HIV-1 RNA stratum (\<= 100,000 vs. \> 100,000 copies/mL).|Cochran-Mantel-Haenszel||The difference in percentage of participants between LEN-containing treatment groups and the B/F/TAF group, and its 95% CI were calculated based on the MH proportions adjusted by baseline HIV-1 RNA stratum (≤ 100,000 vs \> 100,000 copies/mL).|||9.1|-23.5|0.3797
72589928|NCT04143594|144711388|SUPERIORITY||Difference in percentage|-5.5||||0.2398|TWO_SIDED|95.0|-15.9|4.8||P-value was from the CMH tests stratified by baseline HIV-1 RNA stratum (\<= 100,000 vs. \> 100,000 copies/mL).|Cochran-Mantel-Haenszel||The difference in percentage of participants between LEN-containing treatment groups and the B/F/TAF group, and its 95% CI were calculated based on the MH proportions adjusted by baseline HIV-1 RNA stratum (≤ 100,000 vs \> 100,000 copies/mL).|||4.8|-15.9|0.2398
72589929|NCT04143594|144711388|SUPERIORITY||Difference in percentage|-7.4||||0.1639|TWO_SIDED|95.0|-18.3|3.4||P-value was from the CMH tests stratified by baseline HIV-1 RNA stratum (\<= 100,000 vs. \> 100,000 copies/mL).|Cochran-Mantel-Haenszel||The difference in percentage of participants between LEN-containing treatment groups and the B/F/TAF group, and its 95% CI were calculated based on the MH proportions adjusted by baseline HIV-1 RNA stratum (≤ 100,000 vs \> 100,000 copies/mL).|||3.4|-18.3|0.1639
72589930|NCT04143594|144711388|SUPERIORITY||Difference in percentage|-5.7||||0.2307|TWO_SIDED|95.0|-16.3|4.9||P-value was from the CMH tests stratified by baseline HIV-1 RNA stratum (\<= 100,000 vs. \> 100,000 copies/mL).|Cochran-Mantel-Haenszel||The difference in percentage of participants between LEN-containing treatment groups and the B/F/TAF group, and its 95% CI were calculated based on the MH proportions adjusted by baseline HIV-1 RNA stratum (≤ 100,000 vs \> 100,000 copies/mL).|||4.9|-16.3|0.2307
72589931|NCT04143594|144711389|SUPERIORITY||Difference in percentage|-6.7||||0.3142|TWO_SIDED|95.0|-20.7|7.3||P-value was from the CMH tests stratified by baseline HIV-1 RNA stratum (\<= 100,000 vs. \> 100,000 copies/mL).|Cochran-Mantel-Haenszel||The difference in percentage of participants between LEN-containing treatment groups and the B/F/TAF group, and its 95% CI were calculated based on the MH proportions adjusted by baseline HIV-1 RNA stratum (≤ 100,000 vs \> 100,000 copies/mL).|||7.3|-20.7|0.3142
72589932|NCT04143594|144711389|SUPERIORITY||Difference in percentage|-7.2||||0.3009|TWO_SIDED|95.0|-21.3|6.8||P-value was from the CMH tests stratified by baseline HIV-1 RNA stratum (\<= 100,000 vs. \> 100,000 copies/mL).|Cochran-Mantel-Haenszel||The difference in percentage of participants between LEN-containing treatment groups and the B/F/TAF group, and its 95% CI were calculated based on the MH proportions adjusted by baseline HIV-1 RNA stratum (≤ 100,000 vs \> 100,000 copies/mL).|||6.8|-21.3|0.3009
72589933|NCT04143594|144711389|SUPERIORITY||Difference in percentage|-7.6||||0.2859|TWO_SIDED|95.0|-21.8|6.7||P-value was from the CMH tests stratified by baseline HIV-1 RNA stratum (\<= 100,000 vs. \> 100,000 copies/mL).|Cochran-Mantel-Haenszel||The difference in percentage of participants between LEN-containing treatment groups and the B/F/TAF group, and its 95% CI were calculated based on the MH proportions adjusted by baseline HIV-1 RNA stratum (≤ 100,000 vs \> 100,000 copies/mL).|||6.7|-21.8|0.2859
72589934|NCT04143594|144711390|SUPERIORITY||Difference in percentage|-7.1||||0.3686|TWO_SIDED|95.0|-23.2|9.0||P-value was from the CMH tests stratified by baseline HIV-1 RNA stratum (\<= 100,000 vs. \> 100,000 copies/mL).|Cochran-Mantel-Haenszel||The difference in percentage of participants between LEN-containing treatment groups and the B/F/TAF group, and its 95% CI were calculated based on the MH proportions adjusted by baseline HIV-1 RNA stratum (≤ 100,000 vs \> 100,000 copies/mL).|||9.0|-23.2|0.3686
72589935|NCT04143594|144711390|SUPERIORITY||Difference in percentage|-16.5||||0.0887|TWO_SIDED|95.0|-34.0|1.0||P-value was from the CMH tests stratified by baseline HIV-1 RNA stratum (\<= 100,000 vs. \> 100,000 copies/mL).|Cochran-Mantel-Haenszel||The difference in percentage of participants between LEN-containing treatment groups and the B/F/TAF group, and its 95% CI were calculated based on the MH proportions adjusted by baseline HIV-1 RNA stratum (≤ 100,000 vs \> 100,000 copies/mL).|||1.0|-34.0|0.0887
72589936|NCT04143594|144711390|SUPERIORITY||Difference in percentage|-5.4||||0.4949|TWO_SIDED|95.0|-21.5|10.7||P-value was from the CMH tests stratified by baseline HIV-1 RNA stratum (\<= 100,000 vs. \> 100,000 copies/mL).|Cochran-Mantel-Haenszel||The difference in percentage of participants between LEN-containing treatment groups and the B/F/TAF group, and its 95% CI were calculated based on the MH proportions adjusted by baseline HIV-1 RNA stratum (≤ 100,000 vs \> 100,000 copies/mL).|||10.7|-21.5|0.4949
72589937|NCT04143594|144711391|SUPERIORITY||Difference in LSM|0.08||||0.5755|TWO_SIDED|95.0|-0.2|0.37||P-value was from analysis of variance (ANOVA) model adjusting for the baseline HIV-1 RNA level (\<= 100,000 copies/mL or \> 100,000 copies/mL).|ANOVA||Difference in least squares means (Diff in LSM), and its 95% CI were from ANOVA model adjusting for the baseline HIV-1 RNA level (\<= 100,000 copies/mL or \> 100,000 copies/mL).|||0.37|-0.20|0.5755
72589938|NCT04143594|144711391|SUPERIORITY||Difference in LSM|0.02||||0.8697|TWO_SIDED|95.0|-0.25|0.29||P-value was from (ANOVA) model adjusting for the baseline HIV-1 RNA level (\<= 100,000 copies/mL or \> 100,000 copies/mL).|ANOVA||Difference in LSM, and its 95% CI were from ANOVA model adjusting for the baseline HIV-1 RNA level (\<= 100,000 copies/mL or \> 100,000 copies/mL).|||0.29|-0.25|0.8697
72589939|NCT04143594|144711391|SUPERIORITY||Difference in LSM|0.06||||0.7052|TWO_SIDED|95.0|-0.23|0.35||P-value was from (ANOVA) model adjusting for the baseline HIV-1 RNA level (\<= 100,000 copies/mL or \> 100,000 copies/mL).|ANOVA||Difference in LSM, and its 95% CI were from ANOVA model adjusting for the baseline HIV-1 RNA level (\<= 100,000 copies/mL or \> 100,000 copies/mL).|||0.35|-0.23|0.7052
72589940|NCT04143594|144711392|SUPERIORITY||Difference in LSM|0.02||||0.8942|TWO_SIDED|95.0|-0.26|0.3||P-value was from (ANOVA) model adjusting for the baseline HIV-1 RNA level (\<= 100,000 copies/mL or \> 100,000 copies/mL).|ANOVA||Difference in LSM, and its 95% CI were from ANOVA model adjusting for the baseline HIV-1 RNA level (\<= 100,000 copies/mL or \> 100,000 copies/mL).|||0.30|-0.26|0.8942
72589941|NCT04143594|144711392|SUPERIORITY||Difference in LSM|-0.02||||0.9058|TWO_SIDED|95.0|-0.28|0.25||P-value was from (ANOVA) model adjusting for the baseline HIV-1 RNA level (\<= 100,000 copies/mL or \> 100,000 copies/mL).|ANOVA||Difference in LSM, and its 95% CI were from ANOVA model adjusting for the baseline HIV-1 RNA level (\<= 100,000 copies/mL or \> 100,000 copies/mL).|||0.25|-0.28|0.9058
72589942|NCT04143594|144711392|SUPERIORITY||Difference in LSM|0.04||||0.8129|TWO_SIDED|95.0|-0.27|0.35||P-value was from (ANOVA) model adjusting for the baseline HIV-1 RNA level (\<= 100,000 copies/mL or \> 100,000 copies/mL).|ANOVA||Difference in LSM, and its 95% CI were from ANOVA model adjusting for the baseline HIV-1 RNA level (\<= 100,000 copies/mL or \> 100,000 copies/mL).|||0.35|-0.27|0.8129
72589943|NCT04143594|144711393|SUPERIORITY||Difference in LSM|0.04||||0.7864|TWO_SIDED|95.0|-0.25|0.33||P-value was from (ANOVA) model adjusting for the baseline HIV-1 RNA level (\<= 100,000 copies/mL or \> 100,000 copies/mL).|ANOVA||Difference in LSM, and its 95% CI were from ANOVA model adjusting for the baseline HIV-1 RNA level (\<= 100,000 copies/mL or \> 100,000 copies/mL).|||0.33|-0.25|0.7864
72589944|NCT04143594|144711393|SUPERIORITY||Difference in LSM|-0.05||||0.7013|TWO_SIDED|95.0|-0.31|0.21||P-value was from (ANOVA) model adjusting for the baseline HIV-1 RNA level (\<= 100,000 copies/mL or \> 100,000 copies/mL).|ANOVA||Difference in LSM, and its 95% CI were from ANOVA model adjusting for the baseline HIV-1 RNA level (\<= 100,000 copies/mL or \> 100,000 copies/mL).|||0.21|-0.31|0.7013
72414170|NCT03822533|144337319|SUPERIORITY||Mean Difference (Final Values)|2.8||||0.96|TWO_SIDED|95.0|-113.0|118.0|||t-test, 2 sided|||||118|-113|0.96
72414171|NCT02349295|144337334|OTHER||Odds Ratio (OR)|4.74|||<|0.001|TWO_SIDED|95.0|2.65|8.48||model includes: treatment, geographic region, and tumor necrosis factor inhibitor (TNFi) experience (inadequate responder to 1 TNFi, inadequate responder to 2 TNFi, or intolerance to a TNFi).|Regression, Logistic|1\) uses a Wald's test , 2) Non-responder imputation (NRI) was used to calculate the response rates.||||8.48|2.65|<0.001
72414172|NCT02349295|144337334|OTHER|1\) uses a Wald's test , 2) Non-responder imputation (NRI) was used to calculate the response rates.|Odds Ratio (OR)|3.79|||<|0.001|TWO_SIDED|95.0|2.12|6.78|||Regression, Logistic|||model includes: treatment, geographic region, and TNFi experience (inadequate responder to 1 TNFi, inadequate responder to 2 TNFi, or intolerance to a TNFi)||6.78|2.12|<0.001
72414173|NCT01259713|144337362|NON_INFERIORITY_OR_EQUIVALENCE|For the interim analysis performed when 50% of the subjects had completed the study, an alpha of 0.0003 was spent. Therefore, the significance level for the 2-sided test in the primary analysis at the end of the study was 0.0497 (corresponding to 95.03% confidence interval (CI)).|Relative risk reduction|0.33||||0.24|TWO_SIDED|95.03|-0.32|0.66||P-value was from a stratum-adjusted (stratified by region) CMH test.|Cochran-Mantel-Haenszel||Relative risk reduction = 1 - risk ratio.|A two-group Cochran-Mantel-Haenszel (CMH) test with a 0.05 two-sided significance level and 2:1 allocation of 354 randomized subjects (236 AmBisome, 118 placebo) would have 81% power to detect a relative reduction of 75% if the rate of IFI is 10% in the placebo group (based on unpublished data from the German Multicenter Acute Lymphoblastic Leukemia Working Group (GMALL) and consistent with the published rate of 16.4% in patients with hematological malignancies undergoing remission induction).||0.66|-0.32|0.24
72414174|NCT01259713|144337363|SUPERIORITY_OR_OTHER||Relative risk reduction|0.25||||0.15|TWO_SIDED|95.0|-0.11|0.5||P-value was from a stratum-adjusted (stratified by region) CMH test.|Cochran-Mantel-Haenszel||Relative risk reduction = 1 - risk ratio.|||0.50|-0.11|0.15
72589945|NCT04143594|144711393|SUPERIORITY||Difference in LSM|0.22||||0.2753|TWO_SIDED|95.0|-0.18|0.62||P-value was from (ANOVA) model adjusting for the baseline HIV-1 RNA level (\<= 100,000 copies/mL or \> 100,000 copies/mL).|ANOVA||Difference in LSM, and its 95% CI were from ANOVA model adjusting for the baseline HIV-1 RNA level (\<= 100,000 copies/mL or \> 100,000 copies/mL).|||0.62|-0.18|0.2753
72589946|NCT04143594|144711394|SUPERIORITY||Difference in LSM|0.08||||0.564|TWO_SIDED|95.0|-0.19|0.34||P-value was from (ANOVA) model adjusting for the baseline HIV-1 RNA level (\<= 100,000 copies/mL or \> 100,000 copies/mL).|ANOVA||Difference in LSM, and its 95% CI were from ANOVA model adjusting for the baseline HIV-1 RNA level (\<= 100,000 copies/mL or \> 100,000 copies/mL).|||0.34|-0.19|0.5640
72589947|NCT04143594|144711394|SUPERIORITY||Difference in LSM|-0.01||||0.9555|TWO_SIDED|95.0|-0.28|0.26||P-value was from (ANOVA) model adjusting for the baseline HIV-1 RNA level (\<= 100,000 copies/mL or \> 100,000 copies/mL).|ANOVA||Difference in LSM, and its 95% CI were from ANOVA model adjusting for the baseline HIV-1 RNA level (\<= 100,000 copies/mL or \> 100,000 copies/mL).|||0.26|-0.28|0.9555
72589948|NCT04143594|144711394|SUPERIORITY||Difference in LSM|0.14||||0.4025|TWO_SIDED|95.0|-0.19|0.46||P-value was from (ANOVA) model adjusting for the baseline HIV-1 RNA level (\<= 100,000 copies/mL or \> 100,000 copies/mL).|ANOVA||Difference in LSM, and its 95% CI were from ANOVA model adjusting for the baseline HIV-1 RNA level (\<= 100,000 copies/mL or \> 100,000 copies/mL).|||0.46|-0.19|0.4025
72589949|NCT04143594|144711395|SUPERIORITY||Difference in LSM|12.0||||0.7751|TWO_SIDED|95.0|-73.0|97.0||P-value was from (ANOVA) model adjusting for the baseline HIV-1 RNA level (\<= 100,000 copies/mL or \> 100,000 copies/mL).|ANOVA||Difference in LSM, and its 95% CI were from ANOVA model adjusting for the baseline HIV-1 RNA level (\<= 100,000 copies/mL or \> 100,000 copies/mL).|||97|-73|0.7751
72589950|NCT04143594|144711395|SUPERIORITY||Difference in LSM|-2.0||||0.9549|TWO_SIDED|95.0|-79.0|75.0||P-value was from (ANOVA) model adjusting for the baseline HIV-1 RNA level (\<= 100,000 copies/mL or \> 100,000 copies/mL).|ANOVA||Difference in LSM, and its 95% CI were from ANOVA model adjusting for the baseline HIV-1 RNA level (\<= 100,000 copies/mL or \> 100,000 copies/mL).|||75|-79|0.9549
72589951|NCT04143594|144711395|SUPERIORITY||Difference in LSM|44.0||||0.2603|TWO_SIDED|95.0|-33.0|120.0||P-value was from (ANOVA) model adjusting for the baseline HIV-1 RNA level (\<= 100,000 copies/mL or \> 100,000 copies/mL).|ANOVA||Difference in LSM, and its 95% CI were from ANOVA model adjusting for the baseline HIV-1 RNA level (\<= 100,000 copies/mL or \> 100,000 copies/mL).|||120|-33|0.2603
72589952|NCT04143594|144711396|SUPERIORITY||Difference in LSM|-31.0||||0.4827|TWO_SIDED|95.0|-119.0|57.0||P-value was from (ANOVA) model adjusting for the baseline HIV-1 RNA level (\<= 100,000 copies/mL or \> 100,000 copies/mL).|ANOVA||Difference in LSM, and its 95% CI were from ANOVA model adjusting for the baseline HIV-1 RNA level (\<= 100,000 copies/mL or \> 100,000 copies/mL).|||57|-119|0.4827
72589953|NCT04143594|144711396|SUPERIORITY||Difference in LSM|-12.0||||0.7963|TWO_SIDED|95.0|-106.0|81.0||P-value was from (ANOVA) model adjusting for the baseline HIV-1 RNA level (\<= 100,000 copies/mL or \> 100,000 copies/mL).|ANOVA||Difference in LSM, and its 95% CI were from ANOVA model adjusting for the baseline HIV-1 RNA level (\<= 100,000 copies/mL or \> 100,000 copies/mL).|||81|-106|0.7963
72589954|NCT04143594|144711396|SUPERIORITY||Difference in LSM|-22.0||||0.6169|TWO_SIDED|95.0|-111.0|67.0||P-value was from (ANOVA) model adjusting for the baseline HIV-1 RNA level (\<= 100,000 copies/mL or \> 100,000 copies/mL).|ANOVA||Difference in LSM, and its 95% CI were from ANOVA model adjusting for the baseline HIV-1 RNA level (\<= 100,000 copies/mL or \> 100,000 copies/mL).|||67|-111|0.6169
72589955|NCT04143594|144711397|SUPERIORITY||Difference in LSM|21.0||||0.6614|TWO_SIDED|95.0|-73.0|115.0||P-value was from (ANOVA) model adjusting for the baseline HIV-1 RNA level (\<= 100,000 copies/mL or \> 100,000 copies/mL).|ANOVA||Difference in LSM, and its 95% CI were from ANOVA model adjusting for the baseline HIV-1 RNA level (\<= 100,000 copies/mL or \> 100,000 copies/mL).|||115|-73|0.6614
72589956|NCT04143594|144711397|SUPERIORITY||Difference in LSM|20.0||||0.6791|TWO_SIDED|95.0|-75.0|115.0||P-value was from (ANOVA) model adjusting for the baseline HIV-1 RNA level (\<= 100,000 copies/mL or \> 100,000 copies/mL).|ANOVA||Difference in LSM, and its 95% CI were from ANOVA model adjusting for the baseline HIV-1 RNA level (\<= 100,000 copies/mL or \> 100,000 copies/mL).|||115|-75|0.6791
72589957|NCT04143594|144711397|SUPERIORITY||Difference in LSM|27.0||||0.5563|TWO_SIDED|95.0|-65.0|120.0||P-value was from (ANOVA) model adjusting for the baseline HIV-1 RNA level (\<= 100,000 copies/mL or \> 100,000 copies/mL).|ANOVA||Difference in LSM, and its 95% CI were from ANOVA model adjusting for the baseline HIV-1 RNA level (\<= 100,000 copies/mL or \> 100,000 copies/mL).|||120|-65|0.5563
72589958|NCT04143594|144711398|SUPERIORITY||Difference in LSM|32.0||||0.5492|TWO_SIDED|95.0|-75.0|140.0||P-value was from (ANOVA) model adjusting for the baseline HIV-1 RNA level (\<= 100,000 copies/mL or \> 100,000 copies/mL).|ANOVA||Difference in LSM, and its 95% CI were from ANOVA model adjusting for the baseline HIV-1 RNA level (\<= 100,000 copies/mL or \> 100,000 copies/mL).|||140|-75|0.5492
72589959|NCT04143594|144711398|SUPERIORITY||Difference in LSM|17.0||||0.722|TWO_SIDED|95.0|-80.0|115.0||P-value was from (ANOVA) model adjusting for the baseline HIV-1 RNA level (\<= 100,000 copies/mL or \> 100,000 copies/mL).|Difference in LSM||Difference in LSM, and its 95% CI were from ANOVA model adjusting for the baseline HIV-1 RNA level (\<= 100,000 copies/mL or \> 100,000 copies/mL).|||115|-80|0.7220
72589960|NCT04143594|144711398|SUPERIORITY||Difference in LSM|-4.0||||0.9486|TWO_SIDED|95.0|-118.0|110.0||P-value was from (ANOVA) model adjusting for the baseline HIV-1 RNA level (\<= 100,000 copies/mL or \> 100,000 copies/mL).|ANOVA||Difference in LSM, and its 95% CI were from ANOVA model adjusting for the baseline HIV-1 RNA level (\<= 100,000 copies/mL or \> 100,000 copies/mL).|||110|-118|0.9486
72589961|NCT00474201|144711428|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|95.0|||||t-test, 2 sided|Students paired, two-tailed T-test||"Null hypothesis: lopinavir-ritonavir does not alter gemfibrozil pharmacokinetics.~A sample size of 13 healthy subjects yielded 81% power to detect a clinically relevant change of 30% in gemfibrozil AUC with concomitant lopinavir-ritonavir (alpha = 0.05; beta = 0.2). Gemfibrozil pharmacokinetic parameters derived pre- and post lopinavir-ritonavir exposure (Days 1 and 14, respectively) were compared using a paired Students t test."||||<0.0001
72589962|NCT02784613|144711429|SUPERIORITY|||||||0.05||||||Differences in pre- and post-treatment scores were compared using Wilcoxon signed-rank test for non-parametric matched pairs. All tests of significance were 2-tailed. All analyses were performed in Stata®, version 13.|t-test, 2 sided|||||||0.05
72589963|NCT00977314|144711459|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.5|STANDARD_DEVIATION|1.0|<|0.001|||||||t-test, 2 sided|||The endpoint was the calculated difference between the HINT result for the unaided condition prior to the 30-day trial period (Day 1) and the HINT result using the SoundBite (aided) at the end of the 30-day trial period (Day 30).||||<0.001
72589964|NCT00688662|144711496|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-15.6||||0.01|TWO_SIDED|95.0|-28.0|-3.3||The primary analysis was conducted using a logistic regression model with treatment group as the factor of interest and clinical center and PSH status as covariates. A Wald test using a two-tailed significance level of 0.0499 was conducted.|Regression, Logistic|Adjusted and unadjusted risk differences with two-sided 95% confidence intervals are reported in the manuscript.|The unadjusted risk difference and confidence interval was -14.3% (-27.3%, -1.2%).|The trial was designed to test for an overall absolute difference of at least 30% in the primary outcome ('success') in patients treated with sphincterotomy compared to those treated with sham. Using a 2:1 allocation, an assumed 10% non-adherence rate, and one interim analysis for efficacy using O'Brien and Fleming boundaries and futility using conditional power, the study required 214 patients to be randomized to ensure greater than 90% likelihood of identifying this difference.||-3.3|-28.0|0.01
72589965|NCT00688662|144711497|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-9.0|||||TWO_SIDED|95.0|-24.1|5.9||A confidence interval approach was used for examining this outcome.||||Only patients with abnormal manometry were included in this subgroup analysis.||5.9|-24.1|
72589966|NCT03226769|144711540|OTHER|The null hypothesis is that there is no difference between the two devices, TrueTear™ and Thermalon.||||||0.9788||||||Statistically significant (p \< 0.05) and trending significant (p \< 0.10) for within-group or between-group changes from baseline at Day 30. Between-group P-value was calculated using Wilcoxon rank-sum test.|Wilcoxon rank-sum test|||Computer Usage||||0.9788
72589967|NCT03226769|144711540|OTHER|The null hypothesis is that there is no difference between the two devices, TrueTear™ and Thermalon.||||||0.6571||||||Statistically significant (p \< 0.05) and trending significant (p \< 0.10) for within-group or between-group changes from baseline at Day 30. Between-group P-value was calculated using Wilcoxon rank-sum test.|Wilcoxon rank-sum test|||Reading||||0.6571
72589968|NCT03226769|144711540|OTHER|The null hypothesis is that there is no difference between the two devices, TrueTear™ and Thermalon.||||||0.471||||||Statistically significant (p \< 0.05) and trending significant (p \< 0.10) for within-group or between-group changes from baseline at Day 30. Between-group P-value was calculated using Wilcoxon rank-sum test.|Wilcoxon rank-sum test|||Leisure Activities||||0.4710
72589969|NCT03226769|144711540|OTHER|The null hypothesis is that there is no difference between the two devices, TrueTear™ and Thermalon.||||||0.736||||||Statistically significant (p \< 0.05) and trending significant (p \< 0.10) for within-group or between-group changes from baseline at Day 30. Between-group P-value was calculated using Wilcoxon rank-sum test.|Wilcoxon rank-sum test|||Social Activities||||0.7360
72589970|NCT03226769|144711540|OTHER|The null hypothesis is that there is no difference between the two devices, TrueTear™ and Thermalon.||||||0.4999||||||Statistically significant (p \< 0.05) and trending significant (p \< 0.10) for within-group or between-group changes from baseline at Day 30. Between-group P-value was calculated using Wilcoxon rank-sum test.|Wilcoxon rank-sum test|||Driving||||0.4999
72589971|NCT03226769|144711540|OTHER|The null hypothesis is that there is no difference between the two devices, TrueTear™ and Thermalon.||||||0.1159||||||Statistically significant (p \< 0.05) and trending significant (p \< 0.10) for within-group or between-group changes from baseline at Day 30. Between-group P-value was calculated using Wilcoxon rank-sum test.|Wilcoxon rank-sum test|||Outdoor Activities||||0.1159
72589972|NCT03226769|144711540|OTHER|The null hypothesis is that there is no difference between the two devices, TrueTear™ and Thermalon.||||||0.4567||||||Statistically significant (p \< 0.05) and trending significant (p \< 0.10) for within-group or between-group changes from baseline at Day 30. Between-group P-value was calculated using Wilcoxon rank-sum test.|Wilcoxon rank-sum test|||Frequency of Outdoor Activities||||0.4567
72589973|NCT03226769|144711540|OTHER|The null hypothesis is that there is no difference between the two devices, TrueTear™ and Thermalon.||||||0.3439||||||Statistically significant (p \< 0.05) and trending significant (p \< 0.10) for within-group or between-group changes from baseline at Day 30. Between-group P-value was calculated using Wilcoxon rank-sum test.|Wilcoxon rank-sum test|||Time Spent to Take Care of Eyes||||0.3439
72414175|NCT01259713|144337364|SUPERIORITY_OR_OTHER||Relative risk reduction|-0.01||||0.97|TWO_SIDED|95.0|-0.94|0.47||P-value was from a stratum-adjusted (stratified by region) CMH test.|Cochran-Mantel-Haenszel||Relative risk reduction = 1 - risk ratio.|||0.47|-0.94|0.97
72414176|NCT01259713|144337365|SUPERIORITY_OR_OTHER|||||||0.33|TWO_SIDED|||||The p-value is from the log-rank test stratified by region.|Log Rank|||||||0.33
72589974|NCT03226769|144711540|OTHER|The null hypothesis is that there is no difference between the two devices, TrueTear™ and Thermalon.||||||0.3331||||||Statistically significant (p \< 0.05) and trending significant (p \< 0.10) for within-group or between-group changes from baseline at Day 30. Between-group P-value was calculated using Wilcoxon rank-sum test.|Wilcoxon rank-sum test|||Bothered With Amount of Time Taking Care of Eyes||||0.3331
72589975|NCT03226769|144711540|OTHER|The null hypothesis is that there is no difference between the two devices, TrueTear™ and Thermalon.||||||0.4774||||||Statistically significant (p \< 0.05) and trending significant (p \< 0.10) for within-group or between-group changes from baseline at Day 30. Between-group P-value was calculated using Wilcoxon rank-sum test.|Wilcoxon rank-sum test|||Bothered by Appearance||||0.4774
72589976|NCT03226769|144711541|OTHER|The null hypothesis is that there is no difference between the two devices, TrueTear™ and Thermalon.||||||0.5457||||||Statistically significant (p \< 0.05) and trending significant (p \< 0.10) for within-group or between-group changes from baseline at Day 30. Between-group P-value was calculated using Wilcoxon rank-sum test.|Wilcoxon rank-sum test|||Red Eyes||||0.5457
72589977|NCT03226769|144711541|OTHER|The null hypothesis is that there is no difference between the two devices, TrueTear™ and Thermalon.||||||0.9786||||||Statistically significant (p \< 0.05) and trending significant (p \< 0.10) for within-group or between-group changes from baseline at Day 30. Between-group P-value was calculated using Wilcoxon rank-sum test.|Wilcoxon rank-sum test|||Blurred Vision||||0.9786
72414177|NCT01259713|144337366|SUPERIORITY_OR_OTHER||Relative risk reduction|0.25||||0.22|TWO_SIDED|95.0|-0.19|0.53||P-value was from a stratum-adjusted (stratified by region) CMH test.|Cochran-Mantel-Haenszel||Relative risk reduction = 1 - risk ratio.|||0.53|-0.19|0.22
72414178|NCT01259713|144337367|SUPERIORITY_OR_OTHER|||||||0.32|TWO_SIDED|||||P-value was from a stratum-adjusted (stratified by region) CMH test.|Cochran-Mantel-Haenszel|||||||0.32
72414179|NCT01259713|144337368|SUPERIORITY_OR_OTHER|||||||0.32|TWO_SIDED|||||P-value was from a stratum-adjusted (stratified by region) CMH test.|Cochran-Mantel-Haenszel|||||||0.32
72414180|NCT01259713|144337369|SUPERIORITY_OR_OTHER|||||||0.69|TWO_SIDED|||||The p-value was from the log-rank test stratified by region.|Log Rank|Participants without consolidation/salvage therapy dates were censored using the earlier of the Early Termination and Study Completion dates.||||||0.69
72589978|NCT03226769|144711541|OTHER|The null hypothesis is that there is no difference between the two devices, TrueTear™ and Thermalon.||||||0.3894||||||Statistically significant (p \< 0.05) and trending significant (p \< 0.10) for within-group or between-group changes from baseline at Day 30. Between-group P-value was calculated using Wilcoxon rank-sum test.|Wilcoxon rank-sum test|||Dry Eyes||||0.3894
72589979|NCT03226769|144711541|OTHER|The null hypothesis is that there is no difference between the two devices, TrueTear™ and Thermalon.||||||0.0591||||||Statistically significant (p \< 0.05) and trending significant (p \< 0.10) for within-group or between-group changes from baseline at Day 30. Between-group P-value was calculated using Wilcoxon rank-sum test.|Wilcoxon rank-sum test|||Itchy Eyes||||0.0591
72589980|NCT03226769|144711541|OTHER|The null hypothesis is that there is no difference between the two devices, TrueTear™ and Thermalon.||||||0.1818||||||Statistically significant (p \< 0.05) and trending significant (p \< 0.10) for within-group or between-group changes from baseline at Day 30. Between-group P-value was calculated using Wilcoxon rank-sum test.|Wilcoxon rank-sum test|||Burning Eyes||||0.1818
72589981|NCT03226769|144711541|OTHER|The null hypothesis is that there is no difference between the two devices, TrueTear™ and Thermalon.||||||0.4284||||||Statistically significant (p \< 0.05) and trending significant (p \< 0.10) for within-group or between-group changes from baseline at Day 30. Between-group P-value was calculated using Wilcoxon rank-sum test.|Wilcoxon rank-sum test|||Gritty Eyes||||0.4284
72589982|NCT03226769|144711541|OTHER|The null hypothesis is that there is no difference between the two devices, TrueTear™ and Thermalon.||||||0.1051||||||Statistically significant (p \< 0.05) and trending significant (p \< 0.10) for within-group or between-group changes from baseline at Day 30. Between-group P-value was calculated using Wilcoxon rank-sum test.|Wilcoxon rank-sum test|||Painful Eyes||||0.1051
72589983|NCT03226769|144711541|OTHER|The null hypothesis is that there is no difference between the two devices, TrueTear™ and Thermalon.||||||0.7998||||||Statistically significant (p \< 0.05) and trending significant (p \< 0.10) for within-group or between-group changes from baseline at Day 30. Between-group P-value was calculated using Wilcoxon rank-sum test.|Wilcoxon rank-sum test|||Watery Eyes||||0.7998
72589984|NCT03226769|144711541|OTHER|The null hypothesis is that there is no difference between the two devices, TrueTear™ and Thermalon.||||||0.1229||||||Statistically significant (p \< 0.05) and trending significant (p \< 0.10) for within-group or between-group changes from baseline at Day 30. Between-group P-value was calculated using Wilcoxon rank-sum test.|Wilcoxon rank-sum test|||Swollen Eyelids||||0.1229
72589985|NCT03226769|144711541|OTHER|The null hypothesis is that there is no difference between the two devices, TrueTear™ and Thermalon.||||||0.3907||||||Statistically significant (p \< 0.05) and trending significant (p \< 0.10) for within-group or between-group changes from baseline at Day 30. Between-group P-value was calculated using Wilcoxon rank-sum test.|Wilcoxon rank-sum test|||Red Eyelids||||0.3907
72589986|NCT03226769|144711541|OTHER|The null hypothesis is that there is no difference between the two devices, TrueTear™ and Thermalon.||||||0.0336||||||Statistically significant (p \< 0.05) and trending significant (p \< 0.10) for within-group or between-group changes from baseline at Day 30. Between-group P-value was calculated using Wilcoxon rank-sum test.|Wilcoxon rank-sum test|||Crusty Eyelids||||0.0336
72589987|NCT01516008|144711546|SUPERIORITY_OR_OTHER||Mean Difference (Net)|76.35|||<|0.001|TWO_SIDED|95.0|51.0|101.7||P-value adjusted for multiple treatment group comparisons using the Hochberg method.|ANCOVA|ANCOVA model with treatment group and center as factors and baseline pain intensity as covariate.|Difference is SPID48 in tapentadol IR group minus SPID48 in placebo group.|||101.7|51.0|<0.001
72589988|NCT01516008|144711546|SUPERIORITY_OR_OTHER||Mean Difference (Net)|90.6|||<|0.001|TWO_SIDED|95.0|65.1|116.1||P-value is adjusted for multiple treatment group comparisons using the Hochberg method.|ANCOVA|ANCOVA model with treatment group and center as factors and baseline pain intensity as covariate.|Difference is SPID48 in tapentadol IR group minus SPID48 in placebo group.|||116.1|65.1|<0.001
72589989|NCT01516008|144711547|SUPERIORITY_OR_OTHER||||||<|0.001||||||P-value adjusted for multiple treatment group comparisons using the Hochberg method.|Log Rank|Stratified by center||||||<0.001
72589990|NCT01516008|144711547|SUPERIORITY_OR_OTHER||||||<|0.001||||||P-value adjusted for multiple treatment group comparisons using the Hochberg method.|Log Rank|Stratified by center||||||<0.001
72589991|NCT01516008|144711548|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Log Rank|Between-group comparison of cumulative distributions of percent reduction||12 hours||||<0.001
72589992|NCT01516008|144711548|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Log Rank|Between-group comparison of cumulative distributions of percent reduction||12 hours||||<0.001
72589993|NCT01516008|144711548|SUPERIORITY_OR_OTHER|||||||0.001|||||||Log Rank|Between-group comparison of cumulative distributions of percent reduction||24 hours||||0.001
72589994|NCT01516008|144711548|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Log Rank|Between-group comparison of cumulative distributions of percent reduction||24 hours||||<0.001
72414181|NCT01259713|144337370|SUPERIORITY_OR_OTHER||Relative risk reduction|0.08||||0.2|TWO_SIDED|95.0|-0.04|0.19||P-value was from a stratum-adjusted (stratified by region) CMH test.|Cochran-Mantel-Haenszel||Relative risk reduction = 1 - risk ratio.|Participants were not stratified for leukemia risk.||0.19|-0.04|0.20
72589995|NCT01516008|144711548|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Log Rank|Between-group comparison of cumulative distributions of percent reduction||48 hours||||<0.001
72589996|NCT01516008|144711548|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Log Rank|Between-group comparison of cumulative distributions of percent reduction||48 hours||||<0.001
72589997|NCT01516008|144711548|SUPERIORITY_OR_OTHER|||||||0.001|||||||Log Rank|Between-group comparison of cumulative distributions of percent reduction||72 hours||||0.001
72589998|NCT01516008|144711548|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Log Rank|Between-group comparison of cumulative distributions of percent reduction||72 hours||||<0.001
72589999|NCT01516008|144711549|SUPERIORITY_OR_OTHER|||||||0.001|||||||Cochran-Mantel-Haenszel|Controlling for center||12 hours||||0.001
72590000|NCT01516008|144711549|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|Controlling for center||12 hours||||<0.001
72590001|NCT01516008|144711549|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|Controlling for center||24 hours||||<0.001
72590002|NCT01516008|144711549|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|Controlling for center||24 hours||||<0.001
72590003|NCT01516008|144711549|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|Controlling for center||48 hours||||<0.001
72590004|NCT01516008|144711549|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|Controlling for center||48 hours||||<0.001
72590005|NCT01516008|144711549|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|Controlling for center||72 hours||||<0.001
72590006|NCT01516008|144711549|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|Controlling for center||72 hours||||<0.001
72590007|NCT01516008|144711550|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|Controlling for center||12 hours||||<0.001
72590008|NCT01516008|144711550|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|Controlling for center||12 hours||||<0.001
72590009|NCT01516008|144711550|SUPERIORITY_OR_OTHER|||||||0.021|||||||Cochran-Mantel-Haenszel|Controlling for center||24 hours||||0.021
72590010|NCT01516008|144711550|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|Controlling for center||24 hours||||<0.001
72590011|NCT01516008|144711550|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|Controlling for center||48 hours||||<0.001
72590012|NCT01516008|144711550|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|Controlling for center||48 hours||||<0.001
72590013|NCT01516008|144711550|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|Controlling for center||72 hours||||<0.001
72414182|NCT06111742|144337371|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||Induction||||<0.001
72414183|NCT06111742|144337371|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||OR entry||||<0.001
72414184|NCT06111742|144337372|SUPERIORITY|||||||0.022|||||||t-test, 2 sided|||||||0.022
72414185|NCT06111742|144337374|SUPERIORITY|||||||0.046|||||||t-test, 2 sided|||||||0.046
72590014|NCT01516008|144711550|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|Controlling for center||72 hours||||<0.001
72590015|NCT01516008|144711551|SUPERIORITY_OR_OTHER||Mean Difference (Net)|16.52|||<|0.001|TWO_SIDED|95.0|11.1|22.0|||ANCOVA|ANCOVA with treatment group and center as factors and baseline pain intensity as covariate.|Difference is SPID12 in tapentadol IR group minus SPID12 in placebo group.|12 hours||22.0|11.1|<0.001
72590016|NCT01516008|144711551|SUPERIORITY_OR_OTHER||Mean Difference (Net)|19.11|||<|0.001|TWO_SIDED|95.0|13.6|24.6|||ANCOVA|ANCOVA with treatment group and center as factors and baseline pain intensity as covariate.|Difference is SPID12 in tapentadol IR group minus SPID12 in placebo group.|12 hours||24.6|13.6|<0.001
72590017|NCT01516008|144711551|SUPERIORITY_OR_OTHER||Mean Difference (Net)|34.71|||<|0.001|TWO_SIDED|95.0|23.2|46.2|||ANCOVA|ANCOVA with treatment group and center as factors and baseline pain intensity as covariate.|Difference is SPID24 in tapentadol IR group minus SPID24 in placebo group.|24 hours||46.2|23.2|<0.001
72590018|NCT01516008|144711551|SUPERIORITY_OR_OTHER||Mean Difference (Net)|43.04|||<|0.001|TWO_SIDED|95.0|31.5|54.6|||ANCOVA|ANCOVA with treatment group and center as factors and baseline pain intensity as covariate.|Difference is SPID24 in tapentadol IR group minus SPID24 in placebo group.|24 hours||54.6|31.5|<0.001
72590019|NCT01516008|144711551|SUPERIORITY_OR_OTHER||Mean Difference (Net)|122.32|||<|0.001|TWO_SIDED|95.0|81.8|162.9|||ANCOVA|ANCOVA with treatment group and center as factors and baseline pain intensity as covariate.|Difference is SPID72 in tapentadol IR group minus SPID72 in placebo group.|72 hours||162.9|81.8|<0.001
72590020|NCT01516008|144711551|SUPERIORITY_OR_OTHER||Mean Difference (Net)|138.57|||<|0.001||95.0|97.8|179.4|||ANCOVA|ANCOVA with treatment group and center as factors and baseline pain intensity as covariate.|Difference is SPID72 in tapentadol IR group minus SPID72 in placebo group.|72 hours||179.4|97.8|<0.001
72590021|NCT01516008|144711552|SUPERIORITY_OR_OTHER||Mean Difference (Net)|7.15|||<|0.001|TWO_SIDED|95.0|5.0|9.3|||ANCOVA|ANCOVA including treatment group and center as factors and baseline pain intenstidy as covariate|Difference is TOTPAR12 in tapentadol IR group minus TOTPAR12 in placebo group|12 hours||9.3|5.0|<0.001
72590022|NCT01516008|144711552|SUPERIORITY_OR_OTHER||Mean Difference (Net)|7.13|||<|0.001|TWO_SIDED|95.0|4.9|9.3|||ANCOVA|ANCOVA including treatment group and center as factors and baseline pain intenstidy as covariate|Difference is TOTPAR12 in tapentadol IR group minus TOTPAR12 in placebo group|12 hours||9.3|4.9|<0.001
72590023|NCT01516008|144711552|SUPERIORITY_OR_OTHER||Mean Difference (Net)|15.21|||<|0.001|TWO_SIDED|95.0|10.6|19.8|||ANCOVA|ANCOVA including treatment group and center as factors and baseline pain intenstidy as covariate|Difference is TOTPAR24 in tapentadol IR group minus TOTPAR24 in placebo group|24 hours||19.8|10.6|<0.001
72590024|NCT01516008|144711552|SUPERIORITY_OR_OTHER||Mean Difference (Net)|15.54|||<|0.001|TWO_SIDED|95.0|10.9|20.2|||ANCOVA|ANCOVA including treatment group and center as factors and baseline pain intenstidy as covariate|Difference is TOTPAR24 in tapentadol IR group minus TOTPAR24 in placebo group|24 hours||20.2|10.9|<0.001
72590025|NCT01516008|144711552|SUPERIORITY_OR_OTHER||Mean Difference (Net)|34.76|||<|0.001|TWO_SIDED|95.0|24.3|45.3|||ANCOVA|ANCOVA including treatment group and center as factors and baseline pain intenstidy as covariate|Difference is TOTPAR48 in tapentadol IR group minus TOTPAR48 in placebo group|48 hours||45.3|24.3|<0.001
72590026|NCT01516008|144711552|SUPERIORITY_OR_OTHER||Mean Difference (Net)|33.6|||<|0.001|TWO_SIDED|95.0|23.0|44.2|||ANCOVA|ANCOVA including treatment group and center as factors and baseline pain intenstidy as covariate|Difference is TOTPAR48 in tapentadol IR group minus TOTPAR48 in placebo group|48 hours||44.2|23.0|<0.001
72590027|NCT01516008|144711552|SUPERIORITY_OR_OTHER||Mean Difference (Net)|56.59|||<|0.001|TWO_SIDED|95.0|39.4|73.8|||ANCOVA|ANCOVA including treatment group and center as factors and baseline pain intenstidy as covariate|Difference is TOTPAR72 in tapentadol IR group minus TOTPAR72 in placebo group|72 hours||73.8|39.4|<0.001
72590028|NCT01516008|144711552|SUPERIORITY_OR_OTHER||Mean Difference (Net)|53.48|||<|0.001|TWO_SIDED|95.0|36.2|70.8|||ANCOVA|ANCOVA including treatment group and center as factors and baseline pain intenstidy as covariate|Difference is TOTPAR72 in tapentadol IR group minus TOTPAR72 in placebo group|72 hours||70.8|36.2|<0.001
72590029|NCT01516008|144711553|SUPERIORITY_OR_OTHER||Mean Difference (Net)|23.66|||<|0.001|TWO_SIDED|95.0|16.4|30.9|||ANCOVA|ANCOVA with treatment group and center as factors and baseline pain intensity as covariate|Difference is SPRID12 in the tapentadol IR group minus SPRID12 in the placebo group|12 hours||30.9|16.4|<0.001
72590030|NCT01516008|144711553|SUPERIORITY_OR_OTHER||Mean Difference (Net)|26.24|||<|0.001|TWO_SIDED|95.0|18.9|33.6|||ANCOVA|ANCOVA with treatment group and center as factors and baseline pain intensity as covariate|Difference is SPRID12 in the tapentadol IR group minus SPRID12 in the placebo group|12 hours||33.6|18.9|<0.001
72590031|NCT01516008|144711553|SUPERIORITY_OR_OTHER||Mean Difference (Net)|49.93|||<|0.001|TWO_SIDED|95.0|34.4|65.4|||ANCOVA|ANCOVA with treatment group and center as factors and baseline pain intensity as covariate|Difference is SPRID24 in the tapentadol IR group minus SPRID24 in the placebo group|24 hours||65.4|34.4|<0.001
72590032|NCT01516008|144711553|SUPERIORITY_OR_OTHER||Mean Difference (Net)|58.58|||<|0.001|TWO_SIDED|95.0|43.0|74.2|||ANCOVA|ANCOVA with treatment group and center as factors and baseline pain intensity as covariate|Difference is SPRID24 in the tapentadol IR group minus SPRID24 in the placebo group|24 hours||74.2|43.0|<0.001
72590033|NCT01516008|144711553|SUPERIORITY_OR_OTHER||Mean Difference (Net)|111.12|||<|0.001||95.0|76.3|145.9|||ANCOVA|ANCOVA with treatment group and center as factors and baseline pain intensity as covariate|Difference is SPRID48 in the tapentadol IR group minus SPRID48 in the placebo group|48 hours||145.9|76.3|<0.001
72590034|NCT01516008|144711553|SUPERIORITY_OR_OTHER||Mean Difference (Net)|124.21|||<|0.001|TWO_SIDED|95.0|89.2|159.2|||ANCOVA|ANCOVA with treatment group and center as factors and baseline pain intensity as covariate|Difference is SPRID48 in the tapentadol IR group minus SPRID48 in the placebo group|48 hours||159.2|89.2|<0.001
72590035|NCT01516008|144711553|SUPERIORITY_OR_OTHER||Mean Difference (Net)|178.91|||<|0.001|TWO_SIDED|95.0|122.4|235.4|||ANCOVA|ANCOVA with treatment group and center as factors and baseline pain intensity as covariate|Difference is SPRID72 in the tapentadol IR group minus SPRID72 in the placebo group|72 hours||235.4|122.4|<0.001
72590036|NCT01516008|144711553|SUPERIORITY_OR_OTHER||Mean Difference (Net)|192.05|||<|0.001|TWO_SIDED|95.0|135.2|248.9|||ANCOVA|ANCOVA with treatment group and center as factors and baseline pain intensity as covariate|Difference is SPRID72 in the tapentadol IR group minus SPRID72 in the placebo group|72 hours||248.9|135.2|<0.001
72414186|NCT05046795|144337428|SUPERIORITY||Mean Difference (Net)|150.91|STANDARD_ERROR_OF_MEAN|23.727|<|0.0001|TWO_SIDED|95.0|104.145|197.671|||Mixed Models Analysis|||||197.671|104.145|<0.0001
72414187|NCT05046795|144337429|SUPERIORITY||Mean Difference (Net)|144.35|STANDARD_ERROR_OF_MEAN|21.192|<|0.0001|TWO_SIDED|95.0|102.61|186.088|||Mixed Models Analysis|||||186.088|102.610|<0.0001
72414188|NCT05046795|144337430|SUPERIORITY||Mean Difference (Net)|287.75|STANDARD_ERROR_OF_MEAN|38.473|<|0.0001|TWO_SIDED|95.0|211.933|363.57|||Mixed Models Analysis|||||363.570|211.933|<0.0001
72590037|NCT01516008|144711554|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|Controlling for center||||||<0.001
72590038|NCT01516008|144711554|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|Controlling for center||||||<0.001
72590039|NCT05270395|144711593|SUPERIORITY||Odds Ratio (OR)|8.02||||0.02|TWO_SIDED|95.0|1.38|46.69|||Regression, Logistic|||We conducted logistic regression to predict knowledge of palliative care (as measured by ten items in the Health Information National Trends Survey Palliative Care Knowledge and Perceptions Questionnaire) in the mPal intervention arm and in the standard of care arm at 1-month post-intervention, adjusting for baseline value of each item, age, and sex.||46.69|1.38|0.02
72590040|NCT05270395|144711594|SUPERIORITY||Odds Ratio (OR)|1.35||||0.63|TWO_SIDED|95.0|0.4|4.56|||Regression, Logistic|||We conducted logistic regression to predict knowledge of palliative care (as measured by ten items in the Health Information National Trends Survey Palliative Care Knowledge and Perceptions Questionnaire) in the mPal intervention arm and in the standard of care arm at 1-month post-intervention, adjusting for baseline value of each item, age, and sex.||4.56|0.40|0.63
72590041|NCT05270395|144711595|SUPERIORITY||Odds Ratio (OR)|0.29||||0.13|TWO_SIDED|95.0|0.06|1.46|||Regression, Logistic|||We conducted logistic regression to predict knowledge of palliative care (as measured by ten items in the Health Information National Trends Survey Palliative Care Knowledge and Perceptions Questionnaire) in the mPal intervention arm and in the standard of care arm at 1-month post-intervention, adjusting for baseline value of each item, age, and sex.||1.46|0.06|0.13
72369807|NCT02249832|144249991|EQUIVALENCE|A significance level of 0.05 was used (two-sided).|||||<|0.001|||||||ANOVA|||A 3x3 repeated measures ANOVA was performed with group (mean gait speed in the low, moderate, and high groups) and time (admission, discharge (week 6), and follow-up (overall week 18) in each condition) as factors. Null hypothesis was that there was no difference in mean gait speed over time across the three groups. A significance level of 0.05 was used (two-sided).||||<0.001
72590042|NCT05270395|144711596|SUPERIORITY||Odds Ratio (OR)|0.54||||0.4|TWO_SIDED|95.0|0.13|2.24|||Regression, Logistic|||We conducted logistic regression to predict knowledge of palliative care (as measured by ten items in the Health Information National Trends Survey Palliative Care Knowledge and Perceptions Questionnaire) in the mPal intervention arm and in the standard of care arm at 1-month post-intervention, adjusting for baseline value of each item, age, and sex.||2.24|0.13|0.40
72590043|NCT05270395|144711597|SUPERIORITY||Odds Ratio (OR)|2.22||||0.29|TWO_SIDED|95.0|0.51|9.62|||Regression, Logistic|||We conducted logistic regression to predict knowledge of palliative care (as measured by ten items in the Health Information National Trends Survey Palliative Care Knowledge and Perceptions Questionnaire) in the mPal intervention arm and in the standard of care arm at 1-month post-intervention, adjusting for baseline value of each item, age, and sex.||9.62|0.51|0.29
72590044|NCT05270395|144711598|SUPERIORITY||Odds Ratio (OR)|3.55||||0.07|TWO_SIDED|95.0|0.88|14.32|||Regression, Logistic|||We conducted logistic regression to predict knowledge of palliative care (as measured by ten items in the Health Information National Trends Survey Palliative Care Knowledge and Perceptions Questionnaire) in the mPal intervention arm and in the standard of care arm at 1-month post-intervention, adjusting for baseline value of each item, age, and sex.||14.32|0.88|0.07
72590045|NCT05270395|144711599|SUPERIORITY||Odds Ratio (OR)|3.93||||0.09|TWO_SIDED|95.0|0.82|18.89|||Regression, Logistic|||We conducted logistic regression to predict knowledge of palliative care (as measured by ten items in the Health Information National Trends Survey Palliative Care Knowledge and Perceptions Questionnaire) in the mPal intervention arm and in the standard of care arm at 1-month post-intervention, adjusting for baseline value of each item, age, and sex.||18.89|0.82|0.09
72590046|NCT05270395|144711600|SUPERIORITY||Odds Ratio (OR)|1.73||||0.42|TWO_SIDED|95.0|0.46|6.43|||Regression, Logistic|||We conducted logistic regression to predict knowledge of palliative care (as measured by ten items in the Health Information National Trends Survey Palliative Care Knowledge and Perceptions Questionnaire) in the mPal intervention arm and in the standard of care arm at 1-month post-intervention, adjusting for baseline value of each item, age, and sex.||6.43|0.46|0.42
72590047|NCT05270395|144711601|SUPERIORITY||Odds Ratio (OR)|2.86||||0.08|TWO_SIDED|95.0|0.87|9.42|||Regression, Logistic|||We conducted logistic regression to predict knowledge of palliative care (as measured by ten items in the Health Information National Trends Survey Palliative Care Knowledge and Perceptions Questionnaire) in the mPal intervention arm and in the standard of care arm at 1-month post-intervention, adjusting for baseline value of each item, age, and sex.||9.42|0.87|0.08
72369808|NCT02249832|144249992|EQUIVALENCE|A 3x3 repeated measures ANOVA was performed with group (mean distance walked in the low, moderate, and high groups) and time (admission, discharge (week 6), and follow-up (overall week 18) in each condition) as factors. Null hypothesis was that there was no difference in mean gait speed over time across the three groups. A significance level of 0.05 was used (two-sided).||||||0.001||||||A significance level of 0.05 was used (two-sided).|ANOVA|||||||0.001
72590048|NCT05270395|144711602|SUPERIORITY||Odds Ratio (OR)|8.29||||0.004|TWO_SIDED|95.0|1.99|34.49|||Regression, Logistic|||We conducted logistic regression to predict knowledge of palliative care (as measured by ten items in the Health Information National Trends Survey Palliative Care Knowledge and Perceptions Questionnaire) in the mPal intervention arm and in the standard of care arm at 1-month post-intervention, adjusting for baseline value of each item, age, and sex.||34.49|1.99|0.004
72590049|NCT01154296|144711747|SUPERIORITY_OR_OTHER||adjusted risk ratio (aRR)|1.12|||||TWO_SIDED|95.0|0.94|1.33||In the statistical tests of all hypotheses and calculation of the presented risk ratios, we used multiple imputations of data sets with all 5012 cases. The aRRs reported are based on the multiply imputed data. Counts are based on the observed data.|Mantel Haenszel|||A total of 2039/2505 participants randomized to the counseling group and 2032/2507 to the information-only group had complete follow-up STI data. Cumulative STI incidence was 250/2039 (12.3%) in the counseling group and 226/2032 (11.1%) in the information-only group (aRR, 1.12; 95%CI, 0.94-1.33).||1.33|0.94|
72590050|NCT01154296|144711748|SUPERIORITY_OR_OTHER||Incidence rate ratio (IRR)|0.99|||||TWO_SIDED|95.0|0.9|1.09|||||In the statistical tests of all hypotheses and calculation of the presented IRR, we used multiple imputations of data sets with all 5012 cases. The adjusted IRRs reported are based on multiply imputed data. Counts are based on the observed data.|Analyses of sexual risk behaviors used zero-inflated negative binomial regressions (ZINB) including treatment group, baseline level of the risk behavior, site, and randomization stratum. (ZINB regression was used instead of ANCOVA because the outcome variable had an excessive number of zeroes and over dispersion.) Adjusted incidence rate ratios (IRR) from the models are presented.||1.09|0.90|
72590051|NCT01154296|144711749|SUPERIORITY_OR_OTHER||Incidence Rate Ratio (IRR)|0.98|||||TWO_SIDED|95.0|0.86|1.13|||||In the statistical tests of all hypotheses and calculation of the presented IRR, we used multiple imputations of data sets with all 5012 cases. The adjusted IRRs reported are based on multiply imputed data. Counts are based on the observed data.|Analyses of sexual risk behaviors used zero-inflated negative binomial regressions (ZINB) including treatment group, baseline level of the risk behavior, site, and randomization stratum. (ZINB regression was used instead of ANCOVA because the outcome variable had an excessive number of zeroes and over dispersion.) Adjusted incidence rate ratios (IRR) from the models are presented.||1.13|0.86|
72590052|NCT01154296|144711750|SUPERIORITY_OR_OTHER||Incidence Rate Ratio (IRR)|0.88|||||TWO_SIDED|95.0|0.82|0.94|||||In the statistical tests of all hypotheses and calculation of the presented IRR, we used multiple imputations of data sets with all 5012 cases. The adjusted IRRs reported are based on multiply imputed data. Counts are based on the observed data.|Analyses of sexual risk behaviors used zero-inflated negative binomial regressions (ZINB) including treatment group, baseline level of the risk behavior, site, and randomization stratum. (ZINB regression was used instead of ANCOVA because the outcome variable had an excessive number of zeroes and over dispersion.) Adjusted incidence rate ratios (IRR) from the models are presented.||0.94|0.82|
72590053|NCT01154296|144711751|SUPERIORITY_OR_OTHER||Incidence Rate Ratio (IRR)|0.97|||||TWO_SIDED|95.0|0.9|1.05|||||In the statistical tests of all hypotheses and calculation of the presented IRR, we used multiple imputations of data sets with all 5012 cases. The adjusted IRRs reported are based on multiply imputed data. Counts are based on the observed data.|Analyses of sexual risk behaviors used zero-inflated negative binomial regressions (ZINB) including treatment group, baseline level of the risk behavior, site, and randomization stratum. (ZINB regression was used instead of ANCOVA because the outcome variable had an excessive number of zeroes and over dispersion.) Adjusted incidence rate ratios (IRR) from the models are presented.||1.05|0.90|
72590054|NCT01154296|144711752|SUPERIORITY_OR_OTHER||Adjusted Risk Ratio (aRR)|1.14||||||95.0|0.89|1.46||In the statistical tests of all hypotheses and calculation of the presented risk ratios, we used multiple imputations of data sets with all 5012 cases. The aRRs reported are based on the multiply imputed data. Counts are based on the observed data.|Mantel Haenszel|||||1.46|0.89|
72590055|NCT02759055|144711753|SUPERIORITY||Risk Ratio (RR)|1.003|||<|0.05|TWO_SIDED|95.0|0.998|1.008|||Mixed Models Analysis|||||1.008|0.998|<0.05
72590056|NCT02877095|144711754|OTHER|||||||||||||||||All subjects on study received active drug.|Total count of events is provided.|||
72590057|NCT03692325|144711804|SUPERIORITY|||||||0.38|||||||Wilcoxon (Mann-Whitney)|||||||0.38
72590058|NCT00970632|144711811|SUPERIORITY_OR_OTHER||Difference in LS Means|-2.1||||0.001||||||The p-value associated with LS Mean difference of changes from baseline to Week 12 endpoint between tadalafil and placebo treatment groups was for the primary comparison and assessed for significance at a level of 0.05.|ANCOVA|||||||0.001
72590059|NCT00970632|144711811|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.5||||0.023||||||The p-value associated with LS Mean difference of changes from baseline to Week 12 between tamsulosin and placebo treatment groups was secondary in nature and assessed for significance at a level of 0.05 with no adjustments for multiplicity.|ANCOVA|||||||0.023
72590060|NCT00970632|144711812|SUPERIORITY_OR_OTHER||Difference in LS Means|-2.2|||<|0.001||||||The p-value associated with LS Mean difference of changes from baseline to Week 4 between tadalafil and placebo treatment groups was assessed for significance at a level of 0.05.|ANCOVA|||||||<0.001
72590061|NCT00970632|144711812|SUPERIORITY_OR_OTHER||Difference in LS Means|-2.3|||<|0.001||||||The p-value associated with LS Mean difference of changes from baseline to Week 4 between tamsulosin and placebo treatment groups was assessed for significance at a level of 0.05 with no adjustments for multiplicity.|ANCOVA|||||||<0.001
72414189|NCT05046795|144337431|SUPERIORITY||Mean Difference (Net)|105.9|STANDARD_ERROR_OF_MEAN|16.89|<|0.0001|TWO_SIDED|95.0|72.6|139.12|||ANCOVA|||||139.12|72.60|<0.0001
72590062|NCT00970632|144711813|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.6||||0.055||||||The p-value associated with LS Mean difference of changes from baseline to Week 12 between tadalafil versus placebo treatment groups was assessed for significance at a level of 0.05 with no adjustments for multiplicity.|ANCOVA|||||||0.055
72414190|NCT05046795|144337432|SUPERIORITY||Mean Difference (Net)|154.8|STANDARD_ERROR_OF_MEAN|28.37|<|0.0001|TWO_SIDED|95.0|98.86|210.78|||ANCOVA|||||210.78|98.86|<0.0001
72414191|NCT05046795|144337433|SUPERIORITY||Mean Difference (Net)|-4.9|STANDARD_ERROR_OF_MEAN|1.8||0.0064|TWO_SIDED|95.0|-8.49|-1.4|||ANCOVA|||||-1.40|-8.49|0.0064
72414192|NCT05046795|144337434|SUPERIORITY||Odds Ratio (OR)|2.1||||0.0144|TWO_SIDED|95.0|1.16|3.84|||Regression, Logistic|||||3.84|1.16|0.0144
72414193|NCT03836287|144337494|OTHER||Odds Ratio (OR)|2.34||||0.0004|TWO_SIDED|95.0|1.47|3.72|||Regression, Logistic|||||3.72|1.47|0.0004
72590063|NCT00970632|144711813|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.6||||0.055||||||The p-value associated with LS Mean difference of changes from baseline to Week 12 between tamsulosin versus placebo treatment groups was assessed for significance at a level of 0.05 with no adjustments for multiplicity.|ANCOVA|||||||0.055
72590064|NCT00970632|144711814|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.5|||<|0.001||||||The p-value associated with LS Mean difference of changes from baseline to Week 12 between tadalafil versus placebo treatment groups was assessed for significance at a level of 0.05 with no adjustments for multiplicity.|ANCOVA|||||||<0.001
72590065|NCT00970632|144711814|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.0||||0.026||||||The p-value associated with LS Mean difference of changes from baseline to Week 12 between tamsulosin versus placebo treatment groups was assessed for significance at a level of 0.05 with no adjustments for multiplicity.|ANCOVA|||||||0.026
72590066|NCT00970632|144711815|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.2||||0.08||||||The p-value associated with LS Mean difference of changes from baseline to Week 12 between tadalafil versus placebo treatment groups was assessed for significance at a level of 0.05 with no adjustments for multiplicity.|ANCOVA|||||||0.080
72590067|NCT00970632|144711815|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.2||||0.118||||||The p-value associated with LS Mean difference of changes from baseline to Week 12 between tadalafil versus placebo treatment groups was assessed for significance at a level of 0.05 with no adjustments for multiplicity.|ANCOVA|||||||0.118
72590068|NCT00970632|144711816|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.3||||0.022||||||The p-value associated with LS Mean difference of changes from baseline to Week 12 between tadalafil versus placebo treatment groups was assessed for significance at a level of 0.05 with no adjustments for multiplicity.|ANCOVA|||||||0.022
72590069|NCT00970632|144711816|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.1||||0.546||||||The p-value associated with LS Mean difference of changes from baseline to Week 12 endpoint between tamsulosin versus placebo treatment groups was assessed for significance at a level of 0.05 with no adjustments for multiplicity.|ANCOVA|||||||0.546
72590070|NCT00970632|144711817|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.5||||0.003||||||The p-value associated with LS Mean difference of changes from baseline to Week 1 between tadalafil and placebo treatment groups was assessed for significance at a level of 0.05.|ANCOVA|||||||0.003
72590071|NCT00970632|144711817|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.5||||0.005||||||The p-value associated with LS Mean difference of changes from baseline to Week 1 between tamsulosin and placebo treatment groups was assessed for significance at a level of 0.05 with no adjustments for multiplicity.|ANCOVA|||||||0.005
72414194|NCT03836287|144337495|OTHER||Mean Difference (Net)|-29.71|STANDARD_ERROR_OF_MEAN|9.543||0.0019|TWO_SIDED|95.0|-48.42|-11.0|||ANCOVA|||||-11.00|-48.42|0.0019
72590072|NCT00970632|144711818|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.8|||<|0.001||||||The p-value associated with LS Mean difference of changes from baseline to Week 4 between tadalafil and placebo treatment groups was assessed for significance at a level of 0.05.|ANCOVA|||||||<0.001
72590073|NCT00970632|144711818|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.9|||<|0.001||||||The p-value associated with LS Mean difference of changes from baseline to Week 4 between tamsulosin and placebo treatment groups was assessed for significance at a level of 0.05 with no adjustments for multiplicity.|ANCOVA|||||||<0.001
72590074|NCT00970632|144711819|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.8||||0.003||||||The p-value associated with LS Mean difference of changes from baseline to Week 12 between tadalafil and placebo treatment groups was assessed for significance at a level of 0.05.|ANCOVA|||||||0.003
72590075|NCT00970632|144711819|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.6||||0.026||95.0||||The p-value associated with LS Mean difference of changes from baseline to Week 12 endpoint between tamsulosin and placebo treatment groups was assessed for significance at a level of 0.05 with no adjustments for multiplicity.|ANCOVA|||||||0.026
72590076|NCT00970632|144711820|SUPERIORITY_OR_OTHER|||||||0.001||||||The p-value associated with difference between tadalafil versus placebo treatment groups within the 7 response categories was assessed for significance at a level of 0.05 with no adjustment for multiplicity.|Cochran-Mantel-Haenszel|Analysis used data only from these treatment arms and stratification of baseline LUTS severity (moderate \[total IPSS \<20\]; severe \[total IPSS ≥20\]).||||||0.001
72590077|NCT00970632|144711820|SUPERIORITY_OR_OTHER|||||||0.114||95.0||||The p-value associated with difference between tamsulosin versus placebo treatment groups within the 7 response categories was assessed for significance at a level of 0.05 with no adjustment for multiplicity.|Cochran-Mantel-Haenszel|Analysis used data only from these treatment arms and stratification of baseline LUTS severity (moderate \[total IPSS \<20\]; severe \[total IPSS ≥20\]).||||||0.114
72590078|NCT00970632|144711821|SUPERIORITY_OR_OTHER|||||||0.004||||||The p-value associated with difference between tadalafil versus placebo treatment groups within the 7 response categories was assessed for significance at a level of 0.05 with no adjustment for multiplicity.|Cochran-Mantel-Haenszel|Analysis used data only from these treatment arms and a stratification of baseline LUTS severity (moderate \[total IPSS \<20\]; severe \[total IPSS ≥20\]).||||||0.004
72590079|NCT00970632|144711821|SUPERIORITY_OR_OTHER|||||||0.452||||||The p-value associated with difference between tamsulosin versus placebo treatment groups within the 7 response categories was assessed for significance at a level of 0.05 with no adjustment for multiplicity.|Cochran-Mantel-Haenszel|Analysis used data only from these treatment arms and stratification of baseline LUTS severity (moderate \[total IPSS \<20\]; severe \[total IPSS ≥20\]).||||||0.452
72590080|NCT00970632|144711822|SUPERIORITY_OR_OTHER||Median of Treatment Group Differences|-4.4||||0.005||||||The p-value associated with the testing for differences in medians between tadalafil versus placebo treatment groups was assessed for significance at a level of 0.05 with no adjustment for multiplicity.|Van Elteren Tests|P-values testing for differences of medians between placebo and active treatment were based on the Van Elteren test, stratifying by region.||||||0.005
72590081|NCT00970632|144711822|SUPERIORITY_OR_OTHER||Median of Treatment Group Differences|-2.2||||0.457||||||The p-value associated with the testing for differences in medians between tamsulosin versus placebo treatment groups was assessed for significance at a level of 0.05 without adjustments for multiplicity.|Van Elteren Tests|P-values testing for differences of medians between placebo and active treatment were based on the Van Elteren test, stratifying by region.||||||0.457
72590082|NCT00970632|144711823|SUPERIORITY_OR_OTHER||Difference in LS Means|4.0|||<|0.001||||||The p-value associated with LS Mean difference of changes from baseline to Week 12 between tadalafil versus placebo treatment groups was assessed for significance at a level of 0.05 with no adjustment for multiplicity.|ANCOVA|||||||<0.001
72590083|NCT00970632|144711823|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.4||||0.699||||||The p-value associated with LS Mean difference of changes from baseline to Week 12 between tamsulosin versus placebo treatment groups was assessed for significance at a level of 0.05 with no adjustment for multiplicity.|ANCOVA|||||||0.699
72590084|NCT00970632|144711824|SUPERIORITY_OR_OTHER|||||||0.009||||||The p-value associated with median difference of changes from baseline to Week 12 endpoint between tadalafil versus placebo treatment groups was assessed for significance at a level of 0.05 with no adjustment for multiplicity.|ANOVA|Analysis of variance (ANOVA) using rank transformed data.||||||0.009
72590085|NCT00970632|144711824|SUPERIORITY_OR_OTHER|||||||0.014||||||The p-value associated with median difference of changes from baseline to Week 12 endpoint between tamsulosin versus placebo treatment groups was assessed for significance at a level of 0.05 with no adjustment for multiplicity.|ANOVA|ANOVA using rank transformed data.||||||0.014
72590086|NCT00970632|144711827|SUPERIORITY_OR_OTHER|||||||0.303||||||The p-value associated with median difference of changes from baseline to Week 12 endpoint between tadalafil versus placebo treatment groups was assessed for significance at a level of 0.05 with no adjustment for multiplicity.|ANOVA|Analysis of variance (ANOVA) using rank transformed data.||||||0.303
72590087|NCT00970632|144711827|SUPERIORITY_OR_OTHER|||||||0.146||||||The p-value associated with median difference of changes from baseline to Week 12 endpoint between tamsulosin versus placebo treatment groups was assessed for significance at a level of 0.05 with no adjustment for multiplicity.|ANOVA|ANOVA using rank transformed data.||||||0.146
72590088|NCT04304235|144711839|SUPERIORITY||Odds Ratio (OR)|2.22|||||TWO_SIDED|||||||||||||
72590089|NCT00425061|144711849|SUPERIORITY_OR_OTHER||Least squares (LS) mean difference|-5.2||||0.612|TWO_SIDED|95.0|-25.6|15.2|||ANCOVA|||Day 112: Analysis of co-variance (ANCOVA) model was used with baseline as a covariate, long-acting beta-agonist (LABA) use (Inhaled Corticosteroid \[ICS\] only or ICS plus LABA) and treatment as two factors.||15.2|-25.6|0.612
72590090|NCT00425061|144711851|SUPERIORITY_OR_OTHER||LS mean Difference|0.0||||0.482|TWO_SIDED|95.0|-0.2|0.1|||ANCOVA|||Day 8: ANCOVA model was used with baseline as a covariate, LABA use (ICS only or ICS plus LABA) and treatment as two factors.||0.1|-0.2|0.482
72590091|NCT00425061|144711851|SUPERIORITY_OR_OTHER||LS mean difference|0.0||||0.492|TWO_SIDED|95.0|-0.2|0.1|||ANCOVA|||Day 28: ANCOVA model was used with baseline as a covariate, LABA use (ICS only or ICS plus LABA) and treatment as two factors.||0.1|-0.2|0.492
72590092|NCT00425061|144711851|SUPERIORITY_OR_OTHER||LS mean difference|-0.1||||0.323|TWO_SIDED|95.0|-0.2|0.1|||ANCOVA|||Day 56: ANCOVA model was used with baseline as a covariate, LABA use (ICS only or ICS plus LABA) and treatment as two factors.||0.1|-0.2|0.323
72590093|NCT00425061|144711851|SUPERIORITY_OR_OTHER||LS mean difference|-0.1||||0.226|TWO_SIDED|95.0|-0.2|0.1|||ANCOVA|||Day 84: ANCOVA model was used with baseline as a covariate, LABA use (ICS only or ICS plus LABA) and treatment as two factors.||0.1|-0.2|0.226
72590094|NCT00425061|144711851|SUPERIORITY_OR_OTHER||LS mean difference|-0.1||||0.256|TWO_SIDED|95.0|-0.2|0.1|||ANCOVA|||Day 112: ANCOVA model was used with baseline as a covariate, LABA use (ICS only or ICS plus LABA) and treatment as two factors.||0.1|-0.2|0.256
72590095|NCT00425061|144711852|SUPERIORITY_OR_OTHER||LS mean difference|1.8||||0.09|TWO_SIDED|95.0|-0.3|3.9|||ANCOVA|||Day 28: ANCOVA model was based on the log 2 transformed methacholine challenge test values with baseline as a covariate, LABA use (ICS only or ICS plus LABA) and treatment as two factors.||3.9|-0.3|0.090
72590096|NCT00425061|144711852|SUPERIORITY_OR_OTHER||LS mean difference|2.1||||0.144|TWO_SIDED|95.0|-0.8|5.0|||ANCOVA|||Day 112: ANCOVA model was based on the log 2 transformed methacholine challenge test values with baseline as a covariate, LABA use (ICS only or ICS plus LABA) and treatment as two factors.||5.0|-0.8|0.144
72590097|NCT00425061|144711854|SUPERIORITY_OR_OTHER||LS mean difference|-0.1||||0.354|TWO_SIDED|95.0|-0.4|0.1|||ANCOVA|||Day 8: ANCOVA model was used with baseline as a covariate, LABA use (ICS only or ICS plus LABA) and treatment as two factors.||0.1|-0.4|0.354
72590098|NCT00425061|144711854|SUPERIORITY_OR_OTHER||LS mean difference|0.0||||0.9|TWO_SIDED|95.0|-0.4|0.4|||ANCOVA|||Day 28: ANCOVA model was used with baseline as a covariate, LABA use (ICS only or ICS plus LABA) and treatment as two factors.||0.4|-0.4|0.900
72590099|NCT00425061|144711854|SUPERIORITY_OR_OTHER||LS mean difference|0.0||||0.921|TWO_SIDED|95.0|-0.4|0.4|||ANCOVA|||Day 56: ANCOVA model was used with baseline as a covariate, LABA use (ICS only or ICS plus LABA) and treatment as two factors.||0.4|-0.4|0.921
72590100|NCT00425061|144711854|SUPERIORITY_OR_OTHER||LS mean difference|0.2||||0.388|TWO_SIDED|95.0|-0.2|0.6|||ANCOVA|||Day 84: ANCOVA model was used with baseline as a covariate, LABA use (ICS only or ICS plus LABA) and treatment as two factors.||0.6|-0.2|0.388
72590101|NCT00425061|144711854|SUPERIORITY_OR_OTHER||LS mean difference|0.2||||0.249|TWO_SIDED|95.0|-0.2|0.7|||ANCOVA|||Day 112: ANCOVA model was used with baseline as a covariate, LABA use (ICS only or ICS plus LABA) and treatment as two factors.||0.7|-0.2|0.249
72590102|NCT00425061|144711855|SUPERIORITY_OR_OTHER|||||||0.267|TWO_SIDED||||||Chi-squared|||||||0.267
72590103|NCT00425061|144711856|SUPERIORITY_OR_OTHER|||||||0.029|TWO_SIDED||||||Chi-squared|||||||0.029
72590104|NCT05875025|144711919|OTHER||Adjusted mean difference|1.36||||0.442|TWO_SIDED|95.0|-2.28|4.99|||ANCOVA|Analysis of covariance (ANCOVA) model, included treatment, subject, and period as fixed effects; PPR2 at baseline as a covariate.||||4.99|-2.28|0.442
72590105|NCT05875025|144711920|OTHER||Adjusted mean difference|0.7||||0.553|TWO_SIDED|95.0|-1.73|3.12|||ANCOVA|Analysis of covariance (ANCOVA) model, included treatment, subject, and period as fixed effects; PPR4 at baseline as a covariate.||||3.12|-1.73|0.553
72590106|NCT01489254|144711922|NON_INFERIORITY_OR_EQUIVALENCE|To conclude study sensitivity the combined active treatment groups Glatiramer 20 mg and Copaxone 20 mg needed to be superior to placebo.|Ratio (or Ratio of estimated means)|0.488|||||TWO_SIDED|95.0|0.365|0.651|||||Ratio of combined Glatiramer 20 mg + Copaxone 20 mg to placebo and 95% confidence interval.|Estimates represent the mean total lesions during months 7 through 9 and were estimated from the fitted random effect generalized linear model (longitudinal model) with a negative binomial distribution and logaritmic link function. To assess study sensitivity, data of the active treatment groups and placebo were included in the model, resulting in the ratios and 95% CIs for the combined Glatiramer 20 mg and Copaxone 20 mg treatment group and the individual treatments over placebo.||0.651|0.365|
72590107|NCT01489254|144711922|NON_INFERIORITY_OR_EQUIVALENCE|To conclude equivalence between Glatiramer 20 mg and Copaxone 20 mg, efficacy in the combined active treatment groups needed to be superior to placebo (confirming study sensitivity) and the 2-sided 95% CI for the estimated ratio of Glatiramer 20 mg to Copaxone 20 mg needed to be fully enclosed in the prespecified equivalence margin (0.727 - 1.375).|Ratio (or Ratio of estimated means)|1.095|||||TWO_SIDED|95.0|0.883|1.36|||||Ratio of Glatiramer 20 mg to Copaxone 20 mg and 95% confidence interval.|Estimates represent the mean total lesions during months 7 through 9 and were estimated from the fitted random effect generalized linear model (longitudinal model) with a negative binomial distribution and logaritmic link function including Glatiramer 20 mg and Copaxone 20 mg treatment groups to assess study equivalence.||1.360|0.883|
72590108|NCT00507819|144711923|SUPERIORITY_OR_OTHER|||||||0.73|TWO_SIDED||||||Regression, Linear|||||||0.73
72590109|NCT00507819|144711924|SUPERIORITY_OR_OTHER|||||||0.37|TWO_SIDED||||||Regression, Linear|||||||0.37
72590110|NCT00507819|144711925|SUPERIORITY_OR_OTHER|||||||0.05|TWO_SIDED||||||Regression, Linear|||||||0.05
72590111|NCT00507819|144711926|SUPERIORITY_OR_OTHER|||||||0.04|TWO_SIDED||||||Regression, Linear|||||||0.04
72590112|NCT03628339|144711938|OTHER||% Ratio of Geometric Least square Mean|101.4|||||TWO_SIDED|90.0|89.35|115.06||||||||115.06|89.35|
72590113|NCT03628339|144711939|OTHER||% Ratio of Geometric Least square Mean|101.16|||||TWO_SIDED|90.0|89.24|114.66||||||||114.66|89.24|
72590114|NCT03628339|144711940|OTHER||% Ratio of Geometric Least square Mean|103.62|||||TWO_SIDED|90.0|86.91|123.56||||||||123.56|86.91|
72590115|NCT01023256|144711976|SUPERIORITY_OR_OTHER|||||||0.095||||||P values were derived from pairwise comparisons between each MOR103 group and the pooled placebo group based on an analysis of covariance (ANCOVA) model. P values \< 0.05 were considered significant.|ANCOVA|The ANCOVA model included fixed effect terms for dose and the covariate C-reactive protein level at baseline.||||||0.095
72590116|NCT01023256|144711976|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P values were derived from pairwise comparisons between each MOR103 group and the pooled placebo group based on an analysis of covariance (ANCOVA) model. P values \< 0.05 were considered significant.|ANCOVA|The ANCOVA model included fixed effect terms for dose and the covariate C-reactive protein level at baseline.||||||<0.0001
72590117|NCT01023256|144711976|SUPERIORITY_OR_OTHER|||||||0.003||||||P values were derived from pairwise comparisons between each MOR103 group and the pooled placebo group based on an analysis of covariance (ANCOVA) model. P values \< 0.05 were considered significant.|ANCOVA|The ANCOVA model included fixed effect terms for dose and the covariate C-reactive protein level at baseline.||||||0.003
72590118|NCT01023256|144711978|SUPERIORITY_OR_OTHER|||||||0.421||||||P values were derived from pairwise comparisons between each MOR103 group and the pooled placebo group based on an analysis of covariance (ANCOVA) model. P values \< 0.05 were considered significant.|ANCOVA|The ANCOVA model included fixed effect terms for dose and the covariate C-reactive protein level at baseline.||||||0.421
72590119|NCT01023256|144711978|SUPERIORITY_OR_OTHER|||||||0.003||||||P values were derived from pairwise comparisons between each MOR103 group and the pooled placebo group based on an analysis of covariance (ANCOVA) model. P values \< 0.05 were considered significant.|ANCOVA|The ANCOVA model included fixed effect terms for dose and the covariate C-reactive protein level at baseline.||||||0.003
72590120|NCT01023256|144711978|SUPERIORITY_OR_OTHER|||||||0.065||||||P values were derived from pairwise comparisons between each MOR103 group and the pooled placebo group based on an analysis of covariance (ANCOVA) model. P values \< 0.05 were considered significant.|ANCOVA|The ANCOVA model included fixed effect terms for dose and the covariate C-reactive protein level at baseline.||||||0.065
72590121|NCT01023256|144711979|SUPERIORITY_OR_OTHER|||||||0.243||||||P values \<0.05 were considered to be statistically significant.|Fisher Exact|Patients with missing values were not included||||||0.243
72590122|NCT01023256|144711979|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P values \< 0.05 were considered significant.|Fisher Exact|Patients with missing values were not included||||||<0.0001
72590123|NCT01023256|144711979|SUPERIORITY_OR_OTHER|||||||0.135||||||P values \<0.05 were considered to be statistically significant.|Fisher Exact|Patients with missing values were not included.||||||0.135
72590124|NCT03155178|144711983|SUPERIORITY||Mean Difference (Final Values)|-0.23|STANDARD_ERROR_OF_MEAN|0.15||0.13|TWO_SIDED|95.0|-0.53|0.07|||Paired t-test|||"48-hours post-treatment time point. The primary analysis dataset used a modified Intent to Treat population. Subjects were excluded who did not meet the treatment day baseline requirements of greater than or equal to 3.0 log10 CFU/cm\^2 on the abdomen.~The null hypothesis is that there is no difference in log10 CFU /cm\^2 recovery between arms at 48-hours post-treatment."||0.07|-0.53|0.13
72590125|NCT03155178|144711983|SUPERIORITY||Mean Difference (Final Values)|0.04|STANDARD_ERROR_OF_MEAN|0.13||0.78|TWO_SIDED|95.0|-0.23|0.3|||Paired t-test|||"72-hours post-treatment time point. The primary analysis dataset used a modified Intent to Treat population. Subjects were excluded who did not meet the treatment day baseline requirements of greater than or equal to 3.0 log10 CFU/cm\^2 on the abdomen.~The null hypothesis is that there is no difference in log10 CFU /cm\^2 recovery between arms at 72-hours post-treatment."||0.30|-0.23|0.78
72590126|NCT03155178|144711983|SUPERIORITY||Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.17||0.77|TWO_SIDED|95.0|-0.38|0.29|||Paired t-test|||"96-hours post-treatment time point. The primary analysis dataset used a modified Intent to Treat population. Subjects were excluded who did not meet the treatment day baseline requirements of greater than or equal to 3.0 log10 CFU/cm\^2 on the abdomen.~The null hypothesis is that there is no difference in log10 CFU /cm\^2 recovery between arms at 96-hours post-treatment."||0.29|-0.38|0.77
72590127|NCT03155178|144711983|SUPERIORITY||Mean Difference (Final Values)|-0.14|STANDARD_ERROR_OF_MEAN|0.15||0.37|TWO_SIDED|95.0|-0.45|0.17|||Paired t-test|||"48-hours post-treatment time point. The primary analysis dataset used a modified Intent to Treat population. Subjects were excluded who did not meet the treatment day baseline requirements of greater than or equal to 5.0 log10 CFU/cm\^2 on the inguinal.~The null hypothesis is that there is no difference in log10 CFU /cm\^2 recovery between arms at 48-hours post-treatment."||0.17|-0.45|0.37
72369809|NCT02563067|144250008|SUPERIORITY||Rate Ratio|0.69||||0.059|TWO_SIDED|95.0|0.5|0.96|||negative binomial regression model|adjusted p-value, closed testing procedure across the primary and key secondary null hypotheses. Overall type I error rate controlled at two-sided 5%.||||0.96|0.50|0.059
72369810|NCT02563067|144250008|SUPERIORITY||Rate Ratio|0.72||||0.114|TWO_SIDED|95.0|0.52|1.01|||negative binomial regression model|adjusted p-value, closed testing procedure across the primary and key secondary null hypotheses. Overall type I error rate controlled at two-sided 5%.||||1.01|0.52|0.114
72590128|NCT03155178|144711983|SUPERIORITY||Mean Difference (Final Values)|0.19|STANDARD_ERROR_OF_MEAN|0.2||0.33|TWO_SIDED|95.0|-0.2|0.58|||Paired t-test|||"72-hours post-treatment time point. The primary analysis dataset used a modified Intent to Treat population. Subjects were excluded who did not meet the treatment day baseline requirements of greater than or equal to 5.0 log10 CFU/cm\^2 on the inguinal.~The null hypothesis is that there is no difference in log10 CFU /cm\^2 recovery between arms at 72-hours post-treatment."||0.58|-0.20|0.33
72590129|NCT03155178|144711983|SUPERIORITY||Mean Difference (Final Values)|0.07|STANDARD_ERROR_OF_MEAN|0.16||0.65|TWO_SIDED|95.0|-0.25|0.39|||Paired t-test|||"96-hours post-treatment time point. The primary analysis dataset used a modified Intent to Treat population. Subjects were excluded who did not meet the treatment day baseline requirements of greater than or equal to 5.0 log10 CFU/cm\^2 on the inguinal.~The null hypothesis is that there is no difference in log10 CFU /cm\^2 recovery between arms at 96-hours post-treatment."||0.39|-0.25|0.65
72590130|NCT03155178|144711984|SUPERIORITY||Mean Difference (Final Values)|-0.19|STANDARD_ERROR_OF_MEAN|0.22||0.38|TWO_SIDED|95.0|-0.63|0.24|||Paired t-test|||"48-hours post-treatment time point. The primary analysis dataset used a modified Intent to Treat population. Subjects were excluded who did not meet the treatment day baseline requirements of greater than or equal to 3.0 log10 CFU/cm\^2 on the abdomen.~The null hypothesis is that there is no difference in log10 CFU /cm\^2 regrowth from the 10 minute time point between arms at 48-hours post-treatment."||0.24|-0.63|0.38
72590131|NCT03155178|144711984|SUPERIORITY||Mean Difference (Final Values)|0.08|STANDARD_ERROR_OF_MEAN|0.19||0.68|TWO_SIDED|95.0|-0.3|0.45|||Paired t-test|||"72-hours post-treatment time point. The primary analysis dataset used a modified Intent to Treat population. Subjects were excluded who did not meet the treatment day baseline requirements of greater than or equal to 3.0 log10 CFU/cm\^2 on the abdomen.~The null hypothesis is that there is no difference in log10 CFU /cm\^2 regrowth from the 10 minute time point between arms at 72-hours post-treatment."||0.45|-0.30|0.68
72590132|NCT03155178|144711984|SUPERIORITY||Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.23||0.97|TWO_SIDED|95.0|-0.47|0.45|||Paired t-test|||"96-hours post-treatment time point. The primary analysis dataset used a modified Intent to Treat population. Subjects were excluded who did not meet the treatment day baseline requirements of greater than or equal to 3.0 log10 CFU/cm\^2 on the abdomen.~The null hypothesis is that there is no difference in log10 CFU /cm\^2 regrowth from the 10 minute time point between arms at 96-hours post-treatment."||0.45|-0.47|0.97
72590133|NCT03155178|144711984|SUPERIORITY||Mean Difference (Final Values)|0.19|STANDARD_ERROR_OF_MEAN|0.23||0.4|TWO_SIDED|95.0|-0.27|0.65|||Paired t-test|||"48-hours post-treatment time point. The primary analysis dataset used a modified Intent to Treat population. Subjects were excluded who did not meet the treatment day baseline requirements of greater than or equal to 5.0 log10 CFU/cm\^2 on the inguinal.~The null hypothesis is that there is no difference in log10 CFU /cm\^2 regrowth from the 10 minute time point between arms at 48-hours post-treatment."||0.65|-0.27|0.40
72590134|NCT03155178|144711984|SUPERIORITY||Mean Difference (Final Values)|0.54|STANDARD_ERROR_OF_MEAN|0.25||0.03|TWO_SIDED|95.0|0.05|1.03||Using a Hochberg Step-up procedure the critical p value is 0.17|Paired t-test|||"72-hours post-treatment time point. The primary analysis dataset used a modified Intent to Treat population. Subjects were excluded who did not meet the treatment day baseline requirements of greater than or equal to 5.0 log10 CFU/cm\^2 on the inguinal.~The null hypothesis is that there is no difference in log10 CFU /cm\^2 regrowth from the 10 minute time point between arms at 72-hours post-treatment."||1.03|0.05|0.03
72590135|NCT03155178|144711984|SUPERIORITY||Mean Difference (Final Values)|0.42|STANDARD_ERROR_OF_MEAN|0.23||0.07|TWO_SIDED|95.0|-0.03|0.87|||Paired t-test|||"96-hours post-treatment time point. The primary analysis dataset used a modified Intent to Treat population. Subjects were excluded who did not meet the treatment day baseline requirements of greater than or equal to 5.0 log10 CFU/cm\^2 on the inguinal.~The null hypothesis is that there is no difference in log10 CFU /cm\^2 regrowth from the 10 minute time point between arms at 96-hours post-treatment."||0.87|-0.03|0.07
72590136|NCT00834639|144711990|NON_INFERIORITY_OR_EQUIVALENCE|The pharmacokinetic parameters were evaluated statistically by an analysis of variance (ANOVA) appropriate for the experimental design of this study.|Ratio of the T/R geometric mean x 100|97.36||||||90.0|93.68|101.18|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||101.18|93.68|
72590137|NCT00834639|144711991|NON_INFERIORITY_OR_EQUIVALENCE|The pharmacokinetic parameters were evaluated statistically by an analysis of variance (ANOVA) appropriate for the experimental design of this study.|Ratio of the T/R geometric mean x 100|100.59||||||90.0|97.07|104.24|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||104.24|97.07|
72590138|NCT00834639|144711992|NON_INFERIORITY_OR_EQUIVALENCE|The pharmacokinetic parameters were evaluated statistically by an analysis of variance (ANOVA) appropriate for the experimental design of this study.|Ratio of the T/R geometric mean x 100|100.36||||||90.0|97.35|103.46|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||103.46|97.35|
72590139|NCT03382834|144711999|SUPERIORITY|||||||0.68|||||||t-test, 1 sided|The hypothesis was that tamoxifen would enhance the HIV transcription effect of vorinostat (i.e., log10 change would be greater in Arm A than Arm B)||||||0.68
72590140|NCT03382834|144712001|SUPERIORITY|||||||0.73|||||||t-test, 2 sided|||||||0.73
72590141|NCT03613649|144712004|NON_INFERIORITY|Per ICH E14, an increase in the QTcF interval of 5 ms, as evidenced by the upper bound of a 95% one-sided confidence interval above 0.10, is the threshold for regulatory concern. Statistically, the test of prolongation is equivalent to a non-inferiority test versus placebo by crossover design, with an non-inferiority margin of 10 ms.|Least-Squares Mean Double Delta Value|-0.99|||||ONE_SIDED|95.0||0.635||||||"Null Hypothesis: Zoliflodacin administered at a 2 g dose causes a prolongation of the QTcF interval 0.5 h post-dose that exceeds the criteria in the ICH Guidance E14 (5 ms).~Power Calculation:~Enrollment of 72 subjects would provide at least 84% power to conclude a negative effect, given that up to 16 subjects may withdraw early prior to beginning to replace subjects (at least 56 subjects evaluable), and assuming a standard deviation of ΔΔQTcF of 7 msec and an underlying effect of 5 msec."||0.635||
72590142|NCT03613649|144712004|NON_INFERIORITY|Per ICH E14, an increase in the QTcF interval of 5 ms, as evidenced by the upper bound of a 95% one-sided confidence interval above 0.10, is the threshold for regulatory concern.|Least-Squares Mean Double Delta Value|0.59|||||ONE_SIDED|95.0||2.2||||||Null Hypothesis: Zoliflodacin administered at a 2 g dose causes a prolongation of the QTcF interval 1 h post-dose that exceeds the criteria in the ICH Guidance E14 (5 ms).||2.200||
72590143|NCT03613649|144712004|NON_INFERIORITY|Per ICH E14, an increase in the QTcF interval of 5 ms, as evidenced by the upper bound of a 95% one-sided confidence interval above 0.10, is the threshold for regulatory concern.|Least-Squares Mean Double Delta Value|0.17|||||ONE_SIDED|95.0||1.795||||||Null Hypothesis: Zoliflodacin administered at a 2 g dose causes a prolongation of the QTcF interval 2 h post-dose that exceeds the criteria in the ICH Guidance E14 (5 ms).||1.795||
72590144|NCT03613649|144712004|NON_INFERIORITY|Per ICH E14, an increase in the QTcF interval of 5 ms, as evidenced by the upper bound of a 95% one-sided confidence interval above 0.10, is the threshold for regulatory concern.|Least-Squares Mean Double Delta Value|1.42|||||ONE_SIDED|95.0||3.044||||||Null Hypothesis: Zoliflodacin administered at a 2 g dose causes a prolongation of the QTcF interval 3 h post-dose that exceeds the criteria in the ICH Guidance E14 (5 ms).||3.044||
72590145|NCT03613649|144712004|NON_INFERIORITY|Per ICH E14, an increase in the QTcF interval of 5 ms, as evidenced by the upper bound of a 95% one-sided confidence interval above 0.10, is the threshold for regulatory concern.|Least-Squares Mean Double Delta Value|1.17|||||ONE_SIDED|95.0||2.792||||||Null Hypothesis: Zoliflodacin administered at a 2 g dose causes a prolongation of the QTcF interval 4 h post-dose that exceeds the criteria in the ICH Guidance E14 (5 ms).||2.792||
72590146|NCT03613649|144712004|NON_INFERIORITY|Per ICH E14, an increase in the QTcF interval of 5 ms, as evidenced by the upper bound of a 95% one-sided confidence interval above 0.10, is the threshold for regulatory concern.|Least-Squares Mean Double Delta Value|0.45|||||ONE_SIDED|95.0||2.074||||||Null Hypothesis: Zoliflodacin administered at a 2 g dose causes a prolongation of the QTcF interval 6 h post-dose that exceeds the criteria in the ICH Guidance E14 (5 ms).||2.074||
72590147|NCT03613649|144712004|NON_INFERIORITY|Per ICH E14, an increase in the QTcF interval of 5 ms, as evidenced by the upper bound of a 95% one-sided confidence interval above 0.10, is the threshold for regulatory concern.|Least-Squares Mean Double Delta Value|-0.83|||||ONE_SIDED|95.0||0.79||||||Null Hypothesis: Zoliflodacin administered at a 2 g dose causes a prolongation of the QTcF interval 8 h post-dose that exceeds the criteria in the ICH Guidance E14 (5 ms).||0.790||
72590148|NCT03613649|144712004|NON_INFERIORITY|Per ICH E14, an increase in the QTcF interval of 5 ms, as evidenced by the upper bound of a 95% one-sided confidence interval above 0.10, is the threshold for regulatory concern.|Least-Squares Mean Double Delta Value|0.03|||||ONE_SIDED|95.0||1.65||||||Null Hypothesis: Zoliflodacin administered at a 2 g dose causes a prolongation of the QTcF interval 12 h post-dose that exceeds the criteria in the ICH Guidance E14 (5 ms).||1.650||
72590149|NCT03613649|144712004|NON_INFERIORITY|Per ICH E14, an increase in the QTcF interval of 5 ms, as evidenced by the upper bound of a 95% one-sided confidence interval above 0.10, is the threshold for regulatory concern.|Least-Squares Mean Double Delta Value|-0.53|||||ONE_SIDED|95.0||1.131||||||Null Hypothesis: Zoliflodacin administered at a 2 g dose causes a prolongation of the QTcF interval 24 h post-dose that exceeds the criteria in the ICH Guidance E14 (5 ms).||1.131||
72590150|NCT03613649|144712004|NON_INFERIORITY|Per ICH E14, an increase in the QTcF interval of 5 ms, as evidenced by the upper bound of a 95% one-sided confidence interval above 0.10, is the threshold for regulatory concern.|Least-Squares Mean Double Delta Value|1.17|||||ONE_SIDED|95.0||2.815||||||Null Hypothesis: Zoliflodacin administered at a 4 g dose causes a prolongation of the QTcF interval 0.5 h post-dose that exceeds the criteria in the ICH Guidance E14 (5 ms).||2.815||
72590151|NCT03613649|144712004|NON_INFERIORITY|Per ICH E14, an increase in the QTcF interval of 5 ms, as evidenced by the upper bound of a 95% one-sided confidence interval above 0.10, is the threshold for regulatory concern.|Least-Squares Mean Double Delta Value|2.36|||||ONE_SIDED|95.0||3.997||||||Null Hypothesis: Zoliflodacin administered at a 4 g dose causes a prolongation of the QTcF interval 1 h post-dose that exceeds the criteria in the ICH Guidance E14 (5 ms).||3.997||
72590152|NCT03613649|144712004|NON_INFERIORITY|Per ICH E14, an increase in the QTcF interval of 5 ms, as evidenced by the upper bound of a 95% one-sided confidence interval above 0.10, is the threshold for regulatory concern.|Least-Squares Mean Double Delta Value|2.18|||||ONE_SIDED|95.0||3.812||||||Null Hypothesis: Zoliflodacin administered at a 4 g dose causes a prolongation of the QTcF interval 2 h post-dose that exceeds the criteria in the ICH Guidance E14 (5 ms).||3.812||
72590153|NCT03613649|144712004|NON_INFERIORITY|Per ICH E14, an increase in the QTcF interval of 5 ms, as evidenced by the upper bound of a 95% one-sided confidence interval above 0.10, is the threshold for regulatory concern.|Least-Squares Mean Double Delta Value|2.59|||||ONE_SIDED|95.0||4.228||||||Null Hypothesis: Zoliflodacin administered at a 4 g dose causes a prolongation of the QTcF interval 3 h post-dose that exceeds the criteria in the ICH Guidance E14 (5 ms).||4.228||
72590154|NCT03613649|144712004|NON_INFERIORITY|Per ICH E14, an increase in the QTcF interval of 5 ms, as evidenced by the upper bound of a 95% one-sided confidence interval above 0.10, is the threshold for regulatory concern.|Least-Squares Mean Double Delta Value|3.04|||||ONE_SIDED|95.0||4.674||||||Null Hypothesis: Zoliflodacin administered at a 4 g dose causes a prolongation of the QTcF interval 4 h post-dose that exceeds the criteria in the ICH Guidance E14 (5 ms).||4.674||
72590155|NCT03613649|144712004|NON_INFERIORITY|Per ICH E14, an increase in the QTcF interval of 5 ms, as evidenced by the upper bound of a 95% one-sided confidence interval above 0.10, is the threshold for regulatory concern.|Least-Squares Mean Double Delta Value|1.63|||||ONE_SIDED|95.0||3.259||||||Null Hypothesis: Zoliflodacin administered at a 4 g dose causes a prolongation of the QTcF interval 6 h post-dose that exceeds the criteria in the ICH Guidance E14 (5 ms).||3.259||
72590156|NCT03613649|144712004|NON_INFERIORITY|Per ICH E14, an increase in the QTcF interval of 5 ms, as evidenced by the upper bound of a 95% one-sided confidence interval above 0.10, is the threshold for regulatory concern.|Least-Squares Mean Double Delta Value|-0.07|||||ONE_SIDED|95.0||1.566||||||Null Hypothesis: Zoliflodacin administered at a 4 g dose causes a prolongation of the QTcF interval 8 h post-dose that exceeds the criteria in the ICH Guidance E14 (5 ms).||1.566||
72590157|NCT03613649|144712004|NON_INFERIORITY|Per ICH E14, an increase in the QTcF interval of 5 ms, as evidenced by the upper bound of a 95% one-sided confidence interval above 0.10, is the threshold for regulatory concern.|Least-Squares Mean Double Delta Value|1.82|||||ONE_SIDED|95.0||3.459||||||Null Hypothesis: Zoliflodacin administered at a 4 g dose causes a prolongation of the QTcF interval 12 h post-dose that exceeds the criteria in the ICH Guidance E14 (5 ms).||3.459||
72590158|NCT03613649|144712004|NON_INFERIORITY|Per ICH E14, an increase in the QTcF interval of 5 ms, as evidenced by the upper bound of a 95% one-sided confidence interval above 0.10, is the threshold for regulatory concern.|Least-Squares Mean Double Delta Value|1.72|||||ONE_SIDED|95.0||3.415||||||Null Hypothesis: Zoliflodacin administered at a 4 g dose causes a prolongation of the QTcF interval 24 h post-dose that exceeds the criteria in the ICH Guidance E14 (5 ms).||3.415||
72590159|NCT03613649|144712009|NON_INFERIORITY|"According to ICH E14, the positive control should have an effect on the mean QT/QTc interval of about 5 ms. Comparison of the lower bound of the confidence interval to 5 ms for a 400 mg dose of moxifloxacin is standard practice for demonstrating assay sensitivity in thorough QT studies."|Least-Squares Mean Double Delta Value|10.19|||||ONE_SIDED|98.75|8.257|||||||Null Hypothesis: The trial does not have the sensitivity to detect an effect on QTcF of regulatory concern, as produced by 400 mg moxifloxacin 1 h after dose.|||8.257|
72590160|NCT03613649|144712009|NON_INFERIORITY|"According to ICH E14, the positive control should have an effect on the mean QT/QTc interval of about 5 ms. Comparison of the lower bound of the confidence interval to 5 ms for a 400 mg dose of moxifloxacin is standard practice for demonstrating assay sensitivity in thorough QT studies."|Least-Squares Mean Double Delta Value|10.79|||||ONE_SIDED|98.75|8.86|||||||Null Hypothesis: The trial does not have the sensitivity to detect an effect on QTcF of regulatory concern, as produced by 400 mg moxifloxacin 2 h after dose.|||8.860|
72414195|NCT01365494|144337565|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority would be achieved if the lower limit of the two-sided 95% CI of the post vaccination (day 14) ratio of GMCs between the groups (GMCGroup Zagreb / GMCGroup Essen) was greater than 0.667|Ratio of GMCs-Zagreb and Essen at day 14|1.03|||||TWO_SIDED|95.0|0.89|1.19|||ANOVA|||To demonstrate non-inferiority in immune response of the Zagreb postexposure schedule of Rabipur to that of the conventional Essen postexposure schedule at study day 14||1.19|0.89|
72590161|NCT03613649|144712009|NON_INFERIORITY|"According to ICH E14, the positive control should have an effect on the mean QT/QTc interval of about 5 ms. Comparison of the lower bound of the confidence interval to 5 ms for a 400 mg dose of moxifloxacin is standard practice for demonstrating assay sensitivity in thorough QT studies."|Least-Squares Mean Double Delta Value|10.62|||||ONE_SIDED|98.75|8.683|||||||Null Hypothesis: The trial does not have the sensitivity to detect an effect on QTcF of regulatory concern, as produced by 400 mg moxifloxacin 3 h after dose.|||8.683|
72590162|NCT03613649|144712009|NON_INFERIORITY|"According to ICH E14, the positive control should have an effect on the mean QT/QTc interval of about 5 ms. Comparison of the lower bound of the confidence interval to 5 ms for a 400 mg dose of moxifloxacin is standard practice for demonstrating assay sensitivity in thorough QT studies."|Least-Squares Mean Double Delta Value|10.63|||||ONE_SIDED|98.75|8.698|||||||Null Hypothesis: The trial does not have the sensitivity to detect an effect on QTcF of regulatory concern, as produced by 400 mg moxifloxacin 4 h after dose.|||8.698|
72590163|NCT01500187|144712055|SUPERIORITY_OR_OTHER_LEGACY|||||||0.636|||||||ANOVA|||Null Hypothesis: there is no intergroup difference (α=0.05) in DIAGNOdent reading at baseline||||0.636
72590164|NCT01500187|144712055|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|||||||ANOVA|||Null Hypothesis: there is no intergroup difference (α=0.05) in DIAGNOdent reading at three months||||0.001
72590165|NCT01500187|144712055|SUPERIORITY_OR_OTHER_LEGACY|||||||0.423|||||||ANOVA|||Null Hypothesis: there is no intergroup difference (α=0.05) in DIAGNOdent reading at six months||||0.423
72590166|NCT01551264|144712056|OTHER|P-value by chi-square comparing the Kaplan-Meier recurrence-free survival probability at 1.2 years post treatment with robust estimate of standard error due to the a priori assumption that data from bilateral limbs are correlated.||||||0.03|||||||Chi-squared|||||||0.03
72590167|NCT00288600|144712084|SUPERIORITY_OR_OTHER|||||||0.765|TWO_SIDED||||||Chi-squared, Corrected|||Need of Exchange transfusion following the AAP criteria||||0.765
72590168|NCT03600194|144712085|SUPERIORITY|||||||0.019|||||||Mixed Models Analysis|Design\*Therapy interaction term||||||.019
72590169|NCT01582178|144712090|SUPERIORITY_OR_OTHER|||||||0.89||95.0|||||Fisher Exact|||||||0.89
72590170|NCT00784550|144712128|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||||||<0.001
72590171|NCT00784550|144712129|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||||||<0.001
72590172|NCT00784550|144712130|SUPERIORITY_OR_OTHER|||||||0.006||95.0|||||ANCOVA|||||||0.006
72590173|NCT00784550|144712131|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||||||<0.001
72590174|NCT00784550|144712132|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||||||<0.001
72590175|NCT00784550|144712133|SUPERIORITY_OR_OTHER|||||||0.069||95.0||||Mastery domain|ANCOVA|||||||0.069
72590176|NCT00784550|144712133|SUPERIORITY_OR_OTHER|||||||0.47||95.0||||Fatigue domain|ANCOVA|||||||0.470
72590177|NCT00784550|144712133|SUPERIORITY_OR_OTHER|||||||0.394||95.0||||Emotional function domain|ANCOVA|||||||0.394
72590178|NCT00784550|144712133|SUPERIORITY_OR_OTHER|||||||0.879||95.0|||||ANCOVA|Dyspnea domain||||||0.879
72590179|NCT00688701|144712134|SUPERIORITY_OR_OTHER||Least squares (LS) mean difference|-0.54|STANDARD_ERROR_OF_MEAN|0.123|<|0.0001|TWO_SIDED|95.0|-0.785|-0.3||Stepwise testing procedure applied to control type 1 error: Lixisenatide (2-step titration) was compared with Placebo (combined), if found statistically significant, then Lixisenatide (1-step titration) arm compared with Placebo (combined).|ANCOVA|||"To detect a difference of 0.5% in change in HbA1c at Week 12 between 1 lixisenatide arm and placebo (combined), 120 patients per group would provide a power of 90% assuming common standard deviation of 1.2% with 2-sided test at 5% significance level.~Statistical testing: 2-sided at significance level=0.05. Analysis of co-variance (ANCOVA) included treatment arms, randomization strata of screening HbA1c (\<8.0,\>=8.0%), BMI (\<30,\>=30 kg/m\^2), country as fixed effects, baseline HbA1c as covariate."||-0.300|-0.785|<0.0001
72590180|NCT00688701|144712134|SUPERIORITY_OR_OTHER||LS mean difference|-0.66|STANDARD_ERROR_OF_MEAN|0.122|<|0.0001|TWO_SIDED|95.0|-0.903|-0.423||Stepwise testing procedure applied to control type 1 error: Lixisenatide (2-step titration) was compared with Placebo (combined), if found statistically significant, then Lixisenatide (1-step titration) arm compared with Placebo (combined).|ANCOVA|||"To detect a difference of 0.5% in change in HbA1c at Week 12 between 1 lixisenatide arm and placebo (combined), 120 patients per group would provide a power of 90% assuming common standard deviation of 1.2% with 2-sided test at 5% significance level.~Statistical testing: 2-sided at significance level=0.05. Analysis of co-variance (ANCOVA) included treatment arms, randomization strata of screening HbA1c (\<8.0,\>=8.0%), BMI (\<30,\>=30 kg/m\^2), country as fixed effects, baseline HbA1c as covariate."||-0.423|-0.903|<0.0001
72590181|NCT01106677|144712156|NON_INFERIORITY_OR_EQUIVALENCE|Power calculation: assuming a difference between canagliflozin and placebo of 0.5% and a common standard deviation of 1.0%, and using a 2-sample, 1-sided t-test with a Type I error rate of 0.05, it was estimated that 86 subjects per group would provide 90% power to demonstrate superiority of canagliflozin over placebo.|Least-Squares Mean Difference|-0.62|STANDARD_ERROR_OF_MEAN|0.071|<|0.001|TWO_SIDED|95.0|-0.758|-0.481|||ANCOVA|||||-0.481|-0.758|<0.001
72414196|NCT01365494|144337567|SUPERIORITY_OR_OTHER||Ratio of GMCs-Zagreb and Essen at day 7|0.38|||||TWO_SIDED|95.0|0.3|0.48|||ANOVA|||||0.48|0.3|
72590182|NCT01106677|144712156|NON_INFERIORITY_OR_EQUIVALENCE|Power calculation: assuming a difference between canagliflozin and placebo of 0.5% and a common standard deviation of 1.0%, and using a 2-sample, 1-sided t-test with a Type I error rate of 0.05, it was estimated that 86 subjects per group would provide 90% power to demonstrate superiority of canagliflozin over placebo.|Least-Squares Mean Difference|-0.77|STANDARD_ERROR_OF_MEAN|0.071|<|0.001|TWO_SIDED|95.0|-0.914|-0.636|||ANCOVA|||||-0.636|-0.914|<0.001
72590183|NCT01106677|144712156|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-0.66|STANDARD_ERROR_OF_MEAN|0.071|||TWO_SIDED|95.0|-0.795|-0.516||No formal statistical comparison was conducted.|ANCOVA|||||-0.516|-0.795|
72590184|NCT01106677|144712157|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.29|||<|0.001|TWO_SIDED|95.0|1.5|3.5|||Regression, Logistic|||||3.50|1.50|<0.001
72590185|NCT01106677|144712157|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.39|||<|0.001|TWO_SIDED|95.0|2.85|6.77|||Regression, Logistic|||||6.77|2.85|<0.001
72590186|NCT01106677|144712158|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-29.8|STANDARD_ERROR_OF_MEAN|3.044|<|0.001|TWO_SIDED|95.0|-35.76|-23.81|||ANCOVA|||||-23.81|-35.76|<0.001
72590187|NCT01106677|144712158|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-40.3|STANDARD_ERROR_OF_MEAN|3.055|<|0.001|TWO_SIDED|95.0|-46.25|-34.26|||ANCOVA|||||-34.26|-46.25|<0.001
72590188|NCT01106677|144712158|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-22.7|STANDARD_ERROR_OF_MEAN|3.06|||TWO_SIDED|95.0|-28.7|-16.69||No formal statistical comparison was conducted.|ANCOVA|||||-16.69|-28.70|
72590189|NCT01106677|144712159|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-38.1|STANDARD_ERROR_OF_MEAN|5.601|<|0.001|TWO_SIDED|95.0|-49.14|-27.16|||ANCOVA|||||-27.16|-49.14|<0.001
72590190|NCT01106677|144712159|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-47.3|STANDARD_ERROR_OF_MEAN|5.635|<|0.001|TWO_SIDED|95.0|-58.4|-36.29|||ANCOVA|||||-36.29|-58.40|<0.001
72590191|NCT01106677|144712159|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-39.6|STANDARD_ERROR_OF_MEAN|5.608|||TWO_SIDED|95.0|-50.56|-28.55||No formal statistical comparison was conducted.|ANCOVA|||||-28.55|-50.56|
72414197|NCT01365494|144337567|SUPERIORITY_OR_OTHER||Ratio of GMCs-Zagreb and Essen at day 42|0.96||||||95.0|0.86|1.07|||ANOVA|||||1.07|0.86|
72414198|NCT00718718|144337585|SUPERIORITY_OR_OTHER|||||||0.026|||||||Cochran-Mantel-Haenszel|||||||0.026
72414199|NCT00718718|144337585|SUPERIORITY_OR_OTHER|||||||0.052|||||||Cochran-Mantel-Haenszel|||||||0.052
72414200|NCT00718718|144337585|SUPERIORITY_OR_OTHER|||||||0.026|||||||Cochran-Mantel-Haenszel|||||||0.026
72414201|NCT00718718|144337585|SUPERIORITY_OR_OTHER|||||||0.104|||||||Cochran-Mantel-Haenszel|||||||0.104
72414202|NCT00718718|144337586|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Van Der Waerden ANOVA|||||||< 0.001
72414203|NCT00718718|144337586|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Van Der Waerden ANOVA|||||||< 0.001
72414204|NCT00718718|144337586|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Van Der Waerden ANOVA|||||||< 0.001
72414205|NCT00718718|144337586|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Van Der Waerden ANOVA|||||||< 0.001
72590192|NCT01106677|144712160|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-2.5|STANDARD_ERROR_OF_MEAN|0.3|<|0.001|TWO_SIDED|95.0|-3.1|-1.9|||ANCOVA|||||-1.9|-3.1|<0.001
72590193|NCT01106677|144712160|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-2.9|STANDARD_ERROR_OF_MEAN|0.3|<|0.001|TWO_SIDED|95.0|-3.5|-2.3|||ANCOVA|||||-2.3|-3.5|<0.001
72590194|NCT01106677|144712160|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.3|||TWO_SIDED|95.0|-0.6|0.6||No formal statistical comparison was conducted.|ANCOVA|||||0.6|-0.6|
72590195|NCT01106677|144712161|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-5.36|STANDARD_ERROR_OF_MEAN|0.979|<|0.001|TWO_SIDED|95.0|-7.28|-3.439|||ANCOVA|||||-3.439|-7.280|<0.001
72590196|NCT01106677|144712161|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-6.58|STANDARD_ERROR_OF_MEAN|0.981|<|0.001|TWO_SIDED|95.0|-8.504|-4.653|||ANCOVA|||||-4.653|-8.504|<0.001
72590197|NCT01106677|144712161|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-3.34|STANDARD_ERROR_OF_MEAN|0.984|||TWO_SIDED|95.0|-5.273|-1.413||No formal statistical comparison was conducted.|ANCOVA|||||-1.413|-5.273|
72590198|NCT01106677|144712162|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-1.6|STANDARD_ERROR_OF_MEAN|4.2||0.702||95.0|-9.9|6.7|||ANCOVA|||||6.7|-9.9|0.702
72590199|NCT01106677|144712162|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-4.7|STANDARD_ERROR_OF_MEAN|4.3||0.274|TWO_SIDED|95.0|-13.0|3.7|||ANCOVA|||||3.7|-13.0|0.274
72590200|NCT01106677|144712162|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-2.3|STANDARD_ERROR_OF_MEAN|4.3|||TWO_SIDED|95.0|-10.6|6.1||No formal statistical comparison was conducted.|ANCOVA|||||6.1|-10.6|
72590201|NCT01106677|144712163|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|6.7|STANDARD_ERROR_OF_MEAN|1.6|<|0.001|TWO_SIDED|95.0|3.6|9.7|||ANCOVA|||||9.7|3.6|<0.001
72590202|NCT01106677|144712163|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|8.5|STANDARD_ERROR_OF_MEAN|1.6|<|0.001|TWO_SIDED|95.0|5.4|11.5|||ANCOVA|||||11.5|5.4|<0.001
72590203|NCT01106677|144712163|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|1.3|STANDARD_ERROR_OF_MEAN|1.6|||TWO_SIDED|95.0|-1.7|4.4||No formal statistical comparison was conducted.|ANCOVA|||||4.4|-1.7|
72369811|NCT02563067|144250009|SUPERIORITY||Mean Difference (Net)|0.15||||0.369|TWO_SIDED|95.0|-0.02|0.32|||ANCOVA|adjusted p-value, closed testing procedure across the primary and key secondary null hypotheses. Overall type I error rate controlled at two-sided 5%.||||0.32|-0.02|0.369
72590204|NCT01106677|144712164|NON_INFERIORITY_OR_EQUIVALENCE|Assuming a discontinuation rate of 35% at Week 52, with a 2:2:2:1 treatment assignment ratio for canagliflozin 100 mg, canagliflozin 300 mg, sitagliptin 100 mg, or placebo, it was estimated that 360 subjects would need to be randomly assigned to each of the 3 active treatment groups and approximately 180 subjects to the placebo group to demonstrate non-inferiority with a non-inferiority margin of 0.3%.|Least-Squares Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.061|||TWO_SIDED|95.0|-0.119|0.122|||ANCOVA|||||0.122|-0.119|
72590205|NCT01106677|144712164|NON_INFERIORITY_OR_EQUIVALENCE|Assuming a discontinuation rate of 35% at Week 52, with a 2:2:2:1 treatment assignment ratio for canagliflozin 100 mg, canagliflozin 300 mg, sitagliptin 100 mg, or placebo, it was estimated that 360 subjects would need to be randomly assigned to each of the 3 active treatment groups and approximately 180 subjects to the placebo group to demonstrate non-inferiority with a non-inferiority margin of 0.3%.|Least-Squares Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.062|||TWO_SIDED|95.0|-0.273|-0.031|||ANCOVA|||||-0.031|-0.273|
72590206|NCT01106677|144712165|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-8.55|STANDARD_ERROR_OF_MEAN|2.394|<|0.001|TWO_SIDED|95.0|-13.25|-3.857|||ANCOVA|||||-3.857|-13.25|<0.001
72414206|NCT00718718|144337586|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Van Der Waerden ANOVA|||||||< 0.001
72590207|NCT01106677|144712165|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-17.5|STANDARD_ERROR_OF_MEAN|2.404|<|0.001|TWO_SIDED|95.0|-22.24|-12.81|||ANCOVA|||||-12.81|-22.24|<0.001
72590208|NCT01106677|144712166|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-2.4|STANDARD_ERROR_OF_MEAN|0.3|<|0.001|TWO_SIDED|95.0|-3.0|-1.8|||ANCOVA|||||-1.8|-3.0|<0.001
72369812|NCT02563067|144250009|SUPERIORITY||Mean Difference (Net)|0.13||||0.824|TWO_SIDED|95.0|-0.04|0.3|||ANCOVA|adjusted p-value, closed testing procedure across the primary and key secondary null hypotheses. Overall type I error rate controlled at two-sided 5%.||||0.30|-0.04|0.824
72369813|NCT02563067|144250010|SUPERIORITY||Mean Difference (Net)|-0.17||||0.369|TWO_SIDED|95.0|-0.36|0.01|||ANCOVA|adjusted p-value, closed testing procedure across the primary and key secondary null hypotheses. Overall type I error rate controlled at two-sided 5%.||||0.01|-0.36|0.369
72590209|NCT01106677|144712166|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-2.9|STANDARD_ERROR_OF_MEAN|0.3|<|0.001|TWO_SIDED|95.0|-3.4|-2.3|||ANCOVA|||||-2.3|-3.4|<0.001
72590210|NCT01106677|144712167|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-2.87|STANDARD_ERROR_OF_MEAN|0.812|<|0.001|TWO_SIDED|95.0|-4.464|-1.276|||ANCOVA|||||-1.276|-4.464|<0.001
72590211|NCT01106677|144712167|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-3.99|STANDARD_ERROR_OF_MEAN|0.815|<|0.001|TWO_SIDED|95.0|-5.589|-2.389|||ANCOVA|||||-2.389|-5.589|<0.001
72590212|NCT01106677|144712168|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|2.3|STANDARD_ERROR_OF_MEAN|3.2||0.466|TWO_SIDED|95.0|-3.9|8.5|||ANCOVA|||||8.5|-3.9|0.466
72590213|NCT01106677|144712168|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|3.2|STANDARD_ERROR_OF_MEAN|3.2||0.323|TWO_SIDED|95.0|-3.1|9.4|||ANCOVA|||||9.4|-3.1|0.323
72590214|NCT01106677|144712169|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|5.2|STANDARD_ERROR_OF_MEAN|1.4|<|0.001|TWO_SIDED|95.0|2.5|8.0|||ANCOVA|||||8.0|2.5|<0.001
72590215|NCT01106677|144712169|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|7.3|STANDARD_ERROR_OF_MEAN|1.4|<|0.001|TWO_SIDED|95.0|4.5|10.1|||ANCOVA|||||10.1|4.5|<0.001
72590216|NCT03937908|144712170|EQUIVALENCE|Two-sided paired t-tests were used to compare pharmacokinetic and clearance parameters between 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.||||||0.01|||||||t-test, 2 sided|||Asiatic acid||||0.01
72590217|NCT03937908|144712170|EQUIVALENCE|Two-sided paired t-tests were used to compare pharmacokinetic and clearance parameters between 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.||||||0.23|||||||t-test, 2 sided|||Caffeic acid||||0.23
72590218|NCT03937908|144712170|EQUIVALENCE|Two-sided paired t-tests were used to compare pharmacokinetic and clearance parameters between 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.||||||0.001||||||Two-sided paired t-tests were used to compare pharmacokinetic and clearance parameters between 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.|t-test, 2 sided|||Dihydrocaffeic acid||||0.001
72590219|NCT03937908|144712170|EQUIVALENCE|Two-sided paired t-tests were used to compare pharmacokinetic and clearance parameters between 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.||||||0.05|||||||t-test, 2 sided|||Dihydroferulic acid||||0.05
72590220|NCT03937908|144712170|EQUIVALENCE|Two-sided paired t-tests were used to compare pharmacokinetic and clearance parameters between 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.||||||0.07|||||||t-test, 2 sided|||Ferulic acid||||0.07
72590221|NCT03937908|144712170|EQUIVALENCE|Two-sided paired t-tests were used to compare pharmacokinetic and clearance parameters between 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.||||||0.09|||||||t-test, 2 sided|||3-(3-hydroxyphenyl)propionic acid||||0.09
72590222|NCT03937908|144712170|EQUIVALENCE|Two-sided paired t-tests were used to compare pharmacokinetic and clearance parameters between 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.||||||0.003|||||||t-test, 2 sided|||Isoferulic acid||||0.003
72369814|NCT02563067|144250010|SUPERIORITY||Mean Difference (Net)|-0.09||||0.824|TWO_SIDED|95.0|-0.28|0.1|||ANCOVA|adjusted p-value, closed testing procedure across the primary and key secondary null hypotheses. Overall type I error rate controlled at two-sided 5%.||||0.10|-0.28|0.824
72414207|NCT00718718|144337587|SUPERIORITY_OR_OTHER|||||||0.148|||||||Cochran-Mantel-Haenszel|||||||0.148
72369815|NCT02563067|144250011|SUPERIORITY||Mean Difference (Net)|0.068||||0.369|TWO_SIDED|95.0|-0.018|0.154|||ANCOVA|adjusted p-value, closed testing procedure across the primary and key secondary null hypotheses. Overall type I error rate controlled at two-sided 5%.||||0.154|-0.018|0.369
72590223|NCT03937908|144712170|EQUIVALENCE|Two-sided paired t-tests were used to compare pharmacokinetic and clearance parameters between 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.||||||0.1|||||||t-test, 2 sided|||Madecassic acid||||0.10
72590224|NCT03937908|144712170|EQUIVALENCE|Two-sided paired t-tests were used to compare pharmacokinetic and clearance parameters between 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.||||||0.11|||||||t-test, 2 sided|||Monocaffeoylquinic acids||||0.11
72590225|NCT03937908|144712171|EQUIVALENCE|Two-sided paired t-tests were used to compare pharmacokinetic and clearance parameters between 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.||||||0.82|||||||t-test, 2 sided|||Asiatic acid||||0.82
72590226|NCT03937908|144712171|EQUIVALENCE|Two-sided paired t-tests were used to compare pharmacokinetic and clearance parameters between 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.||||||0.4|||||||t-test, 2 sided|||Caffeic acid||||0.40
72590227|NCT03937908|144712171|EQUIVALENCE|Two-sided paired t-tests were used to compare pharmacokinetic and clearance parameters between 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.||||||0.2|||||||t-test, 2 sided|||Dihydrocaffeic acid||||0.20
72590228|NCT03937908|144712171|EQUIVALENCE|Two-sided paired t-tests were used to compare pharmacokinetic and clearance parameters between 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.||||||0.48|||||||t-test, 2 sided|||Dihydroferulic acid||||0.48
72590229|NCT03937908|144712171|EQUIVALENCE|Two-sided paired t-tests were used to compare pharmacokinetic and clearance parameters between 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.||||||0.2|||||||t-test, 2 sided|||Ferulic acid||||0.20
72590230|NCT03937908|144712171|EQUIVALENCE|Two-sided paired t-tests were used to compare pharmacokinetic and clearance parameters between 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.||||||0.32|||||||t-test, 2 sided|||3-(3-hydroxyphenyl)propionic acid||||0.32
72590231|NCT03937908|144712171|EQUIVALENCE|Two-sided paired t-tests were used to compare pharmacokinetic and clearance parameters between 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.||||||0.35|||||||t-test, 2 sided|||Isoferulic acid||||0.35
72590232|NCT03937908|144712171|EQUIVALENCE|Two-sided paired t-tests were used to compare pharmacokinetic and clearance parameters between 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.||||||0.52|||||||t-test, 2 sided|||Madecassic acid||||0.52
72590233|NCT03937908|144712171|EQUIVALENCE|Two-sided paired t-tests were used to compare pharmacokinetic and clearance parameters between 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.||||||0.13|||||||t-test, 2 sided|||Monocaffeoylquinic acids||||0.13
72414208|NCT01462344|144337606|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority comparison was statistically significant if the upper bound of the two-sided 95% CI falls below 2.675, the non-inferiority margin, and the non-inferiority test one-sided p-value \<0.025.|Hazard Ratio (HR)|1.285||||0.006|TWO_SIDED|95.0|0.726|2.272|||Regression, Cox||Estimated for Hazard ratio|||2.272|0.726|0.006
72414209|NCT01462344|144337606|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.0019|||||TWO_SIDED|95.0|-0.0024|0.0063|||||Estimated for Absolute risk difference|||0.0063|-0.0024|
72414210|NCT01462344|144337607|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.859|||||TWO_SIDED|95.0|0.729|1.012|||||Estimated for Hazard ratio|||1.012|0.729|
72414211|NCT03394924|144337645|SUPERIORITY||Odds Ratio (OR)|5.6||||0.106|TWO_SIDED|95.0|0.6|52.0|||Cochran-Mantel-Haenszel|||||52|0.6|0.106
72414212|NCT03394924|144337645|SUPERIORITY||Odds Ratio (OR)|7.0||||0.063|TWO_SIDED|95.0|0.75|65.22|||Cochran-Mantel-Haenszel|||||65.22|0.75|0.063
72414213|NCT03394924|144337649|SUPERIORITY||Least squares mean difference|0.47||||0.616|TWO_SIDED|95.0|-1.39|2.32|||ANCOVA|||Analysis for total bilirubin.||2.32|-1.39|0.616
72414214|NCT03394924|144337649|SUPERIORITY||Least squares mean difference|0.19||||0.844|TWO_SIDED|95.0|-1.78|2.16|||ANCOVA|||Analysis for total bilirubin.||2.16|-1.78|0.844
72414215|NCT03394924|144337649|SUPERIORITY||Least squares mean difference|-0.67||||0.18|TWO_SIDED|95.0|-1.67|0.32|||ANCOVA|||Analysis for conjugated bilirubin.||0.32|-1.67|0.18
72414216|NCT03394924|144337649|SUPERIORITY||Least squares mean difference|-0.64||||0.239|TWO_SIDED|95.0|-1.71|0.44|||ANCOVA|||Analysis for conjugated bilirubin.||0.44|-1.71|0.239
72414217|NCT03394924|144337649|SUPERIORITY||Least squares mean difference|1.21||||0.116|TWO_SIDED|95.0|-0.31|2.73|||ANCOVA|||Analysis for unconjugated bilirubin.||2.73|-0.31|0.116
72590234|NCT03937908|144712172|EQUIVALENCE|Two-sided paired t-tests were used to compare pharmacokinetic and clearance parameters between 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.||||||0.34|||||||t-test, 2 sided|||Asiatic acid||||0.34
72590235|NCT03937908|144712172|EQUIVALENCE|Two-sided paired t-tests were used to compare pharmacokinetic and clearance parameters between 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.||||||0.08|||||||t-test, 2 sided|||Dihydrocaffeic acid||||0.08
72590236|NCT03937908|144712172|EQUIVALENCE|Two-sided paired t-tests were used to compare pharmacokinetic and clearance parameters between 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.||||||0.23|||||||t-test, 2 sided|||Dihydroferulic acid||||0.23
72590237|NCT03937908|144712172|EQUIVALENCE|Two-sided paired t-tests were used to compare pharmacokinetic and clearance parameters between 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.||||||0.14|||||||t-test, 2 sided|||Ferulic acid||||0.14
72590238|NCT03937908|144712172|EQUIVALENCE|Two-sided paired t-tests were used to compare pharmacokinetic and clearance parameters between 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.||||||0.28|||||||t-test, 2 sided|||3-(3-hydroxyphenyl)propionic acid||||0.28
72590239|NCT03937908|144712172|EQUIVALENCE|Two-sided paired t-tests were used to compare pharmacokinetic and clearance parameters between 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.||||||0.17|||||||t-test, 2 sided|||Isoferulic acid||||0.17
72590240|NCT03937908|144712172|EQUIVALENCE|Two-sided paired t-tests were used to compare pharmacokinetic and clearance parameters between 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.||||||0.98|||||||t-test, 2 sided|||Madecassic acid||||0.98
72590241|NCT03937908|144712172|EQUIVALENCE|Two-sided paired t-tests were used to compare pharmacokinetic and clearance parameters between 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.||||||0.16|||||||t-test, 2 sided|||Monocaffeoylquinic acids||||0.16
72590242|NCT03937908|144712173|EQUIVALENCE|Two-sided paired t-tests were used to compare pharmacokinetic and clearance parameters between 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.||||||0.04|||||||t-test, 2 sided|||Asiatic acid||||0.04
72590243|NCT03937908|144712173|EQUIVALENCE|Two-sided paired t-tests were used to compare pharmacokinetic and clearance parameters between 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.||||||0.01|||||||t-test, 2 sided|||Caffeic acid||||0.01
72590244|NCT03937908|144712173|EQUIVALENCE|Two-sided paired t-tests were used to compare pharmacokinetic and clearance parameters between 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.||||||0.06|||||||t-test, 2 sided|||Dihydrocaffeic acid||||0.06
72590245|NCT03937908|144712173|EQUIVALENCE|Two-sided paired t-tests were used to compare pharmacokinetic and clearance parameters between 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.||||||0.08|||||||t-test, 2 sided|||Dihydroferulic acid||||0.08
72590246|NCT03937908|144712173|EQUIVALENCE|Two-sided paired t-tests were used to compare pharmacokinetic and clearance parameters between 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.||||||0.56|||||||t-test, 2 sided|||Dicaffeoylquinic acids||||0.56
72590247|NCT03937908|144712173|EQUIVALENCE|Two-sided paired t-tests were used to compare pharmacokinetic and clearance parameters between 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.||||||0.21|||||||t-test, 2 sided|||Ferulic acid||||0.21
72590248|NCT03937908|144712173|EQUIVALENCE|Two-sided paired t-tests were used to compare pharmacokinetic and clearance parameters between 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.||||||0.05|||||||t-test, 2 sided|||3-(3-hydroxyphenyl)propionic acid||||0.05
72590249|NCT03937908|144712173|EQUIVALENCE|Two-sided paired t-tests were used to compare pharmacokinetic and clearance parameters between 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.||||||0.05|||||||t-test, 2 sided|||Isoferulic acid||||0.05
72414218|NCT03394924|144337649|SUPERIORITY||Least squares mean difference|0.72||||0.36|TWO_SIDED|95.0|-0.84|2.28|||ANCOVA|||Analysis for unconjugated bilirubin.||2.28|-0.84|0.36
72414219|NCT03394924|144337650|SUPERIORITY||Least squares mean difference|-25.55||||0.001|TWO_SIDED|95.0|-40.07|-11.04|||ANCOVA|||Analysis for ALT.||-11.04|-40.07|0.001
72590250|NCT03937908|144712173|EQUIVALENCE|Two-sided paired t-tests were used to compare pharmacokinetic and clearance parameters between 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.||||||0.23|||||||t-test, 2 sided|||Madecassic acid||||0.23
72590251|NCT03937908|144712173|EQUIVALENCE|Two-sided paired t-tests were used to compare pharmacokinetic and clearance parameters between 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.||||||0.16|||||||t-test, 2 sided|||Monocaffeoylquinic acids||||0.16
72590252|NCT03937908|144712174|EQUIVALENCE|Two-sided paired t-tests were used to compare the ng/mL between the 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.||||||0.7|||||||t-test, 2 sided|||Asiatic acid||||0.7
72590253|NCT03937908|144712174|EQUIVALENCE|Two-sided paired t-tests were used to compare the ng/mL between the 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.||||||0.09|||||||t-test, 2 sided|||Madecassic acid||||0.09
72590254|NCT03937908|144712174|EQUIVALENCE|Two-sided paired t-tests were used to compare the ng/mL between the 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.||||||0.4|||||||t-test, 2 sided|||Asiaticoside||||0.4
72590255|NCT03937908|144712174|EQUIVALENCE|Two-sided paired t-tests were used to compare the ng/mL between the 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.||||||0.6|||||||t-test, 2 sided|||Madecassoside||||0.6
72590256|NCT03937908|144712174|EQUIVALENCE|Two-sided paired t-tests were used to compare the ng/mL between the 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.||||||0.4|||||||t-test, 2 sided|||Monocaffeoylquinic acids||||0.4
72590257|NCT03937908|144712174|EQUIVALENCE|Two-sided paired t-tests were used to compare the ng/mL between the 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.||||||0.1|||||||t-test, 2 sided|||Dicaffeoylquinic acids||||0.1
72414220|NCT03394924|144337650|SUPERIORITY||Least squares mean difference|-21.35||||0.009|TWO_SIDED|95.0|-37.1|-5.6|||ANCOVA|||Analysis for ALT.||-5.6|-37.1|0.009
72590258|NCT03937908|144712174|EQUIVALENCE|Two-sided paired t-tests were used to compare the ng/mL between the 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.||||||0.9|||||||t-test, 2 sided|||3-(3-hydroxyphenyl)propionic acid||||0.9
72590259|NCT03937908|144712174|EQUIVALENCE|Two-sided paired t-tests were used to compare the ng/mL between the 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.||||||0.03|||||||t-test, 2 sided|||Caffeic acid||||0.03
72590260|NCT03937908|144712174|EQUIVALENCE|Two-sided paired t-tests were used to compare the ng/mL between the 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.||||||0.9|||||||t-test, 2 sided|||Ferulic acid||||0.9
72590261|NCT03937908|144712174|EQUIVALENCE|Two-sided paired t-tests were used to compare the ng/mL between the 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.||||||0.6|||||||t-test, 2 sided|||Isoferulic acid||||0.6
72414221|NCT03394924|144337650|SUPERIORITY||Least squares mean difference|-21.42||||0|TWO_SIDED|95.0|-32.48|-10.35|||ANCOVA|||Analysis for AST.||-10.35|-32.48|0.000
72414222|NCT03394924|144337650|SUPERIORITY||Least squares mean difference|-20.84||||0.001|TWO_SIDED|95.0|-32.8|-8.87|||ANCOVA|||Analysis for AST.||-8.87|-32.8|0.001
72414223|NCT03394924|144337650|SUPERIORITY||Least squares mean difference|-86.49||||0|TWO_SIDED|95.0|-123.78|-49.21|||ANCOVA|||Analysis for GGT.||-49.21|-123.78|0.000
72414224|NCT03394924|144337650|SUPERIORITY||Least squares mean difference|-115.13||||0|TWO_SIDED|95.0|-155.04|-75.22|||ANCOVA|||Analysis for GGT.||-75.22|-155.04|0.000
72414225|NCT03394924|144337651|SUPERIORITY||Least squares mean difference|-26.66||||0.148|TWO_SIDED|95.0|-63.1|9.79|||ANCOVA|||Analysis for HA.||9.79|-63.1|0.148
72590262|NCT03937908|144712174|EQUIVALENCE|Two-sided paired t-tests were used to compare the ng/mL between the 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.||||||0.4|||||||t-test, 2 sided|||Dihydroferulic acid||||0.4
72590263|NCT03937908|144712174|EQUIVALENCE|Two-sided paired t-tests were used to compare the ng/mL between the 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.||||||0.8|||||||t-test, 2 sided|||Dihydrocaffeic acid||||0.8
72590264|NCT03937908|144712175|EQUIVALENCE|Two-sided paired t-tests were used to compare fold induction between 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.||||||0.1|||||||t-test, 1 sided|||1 hour||||0.1
72590265|NCT03937908|144712175|EQUIVALENCE|Two-sided paired t-tests were used to compare fold induction between 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.||||||0.1|||||||t-test, 1 sided|||2 hours||||0.1
72590266|NCT03937908|144712175|EQUIVALENCE|Two-sided paired t-tests were used to compare fold induction between 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.||||||0.3|||||||t-test, 1 sided|||3 hours||||0.3
72590267|NCT03937908|144712175|EQUIVALENCE|Two-sided paired t-tests were used to compare fold induction between 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.||||||0.5|||||||t-test, 1 sided|||4 hours||||0.5
72590268|NCT03937908|144712175|EQUIVALENCE|Two-sided paired t-tests were used to compare fold induction between 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.||||||0.5|||||||t-test, 1 sided|||6 hours||||0.5
72590269|NCT03875092|144712176|OTHER||Hazard Ratio (HR)|0.35|||||TWO_SIDED|95.0|0.24|0.52|||||Based on unstratified Cox regression model with treatment as a covariate, due to small sample size.|||0.52|0.24|
72590270|NCT03875092|144712177|OTHER||Hazard Ratio (HR)|0.44|||||TWO_SIDED|95.0|0.28|0.7|||||Based on unstratified Cox regression model with treatment as a covariate, due to small sample size.|||0.70|0.28|
72590271|NCT03875092|144712178|OTHER||Difference in Percentage|36.7|||||TWO_SIDED|95.0|19.9|51.6|||||Based on unstratified Miettinen \& Nurminen method, due to small sample size.|||51.6|19.9|
72590272|NCT02163226|144712194|OTHER|2 sided p value||||||0.03|||||||Fisher Exact|||Pain Response Rates (CR+PR) at 2 weeks||||.03
72590273|NCT02163226|144712194|SUPERIORITY|||||||0.19|||||||Fisher Exact|||Pain Response Rates (CR+PR) at 1 month||||.19
72590274|NCT02163226|144712194|OTHER|2 sided p value||||||0.04|||||||Fisher Exact|||Pain Response Rates (CR+PR) at 3 months||||.04
72590275|NCT02163226|144712194|SUPERIORITY|||||||0.89|||||||Fisher Exact|||Pain Response Rates (CR+PR) at 6 months||||.89
72414226|NCT03394924|144337651|SUPERIORITY||Least squares mean difference|-28.99||||0.142|TWO_SIDED|95.0|-68.02|10.05|||ANCOVA|||Analysis for HA.||10.05|-68.02|0.142
72414227|NCT03394924|144337651|SUPERIORITY||Least squares mean difference|-3.09||||0.02|TWO_SIDED|95.0|-5.68|-0.51|||ANCOVA|||Analysis for PIIINP.||-0.51|-5.68|0.02
72414228|NCT03394924|144337651|SUPERIORITY||Least squares mean difference|-3.79||||0.009|TWO_SIDED|95.0|-6.6|-0.97|||ANCOVA|||Analysis for PIIINP.||-0.97|-6.6|0.009
72414229|NCT03394924|144337651|SUPERIORITY||Least squares mean difference|-41.96||||0.015|TWO_SIDED|95.0|-75.47|-8.44|||ANCOVA|||Analysis for TIMP 1.||-8.44|-75.47|0.015
72590276|NCT02163226|144712194|SUPERIORITY|||||||0.07|||||||Fisher Exact|||Pain Response Rates (CR+PR) at 9 months||||.07
72590277|NCT02163226|144712194|OTHER|2 sided p value||||||0.03|||||||Fisher Exact|||Pain Response Rates (CR+PR) at 2 weeks||||.03
72590278|NCT02163226|144712194|OTHER|2 sided p value||||||0.19|||||||Fisher Exact|||Pain Response Rates (CR+PR) at 1 month||||.19
72414230|NCT03394924|144337651|SUPERIORITY||Least squares mean difference|-46.56||||0.011|TWO_SIDED|95.0|-81.91|-11.21|||ANCOVA|||Analysis for TIMP 1.||-11.21|-81.91|0.011
72414231|NCT03394924|144337651|SUPERIORITY||Least squares mean difference|-9.73||||0.018|TWO_SIDED|95.0|-17.7|-1.75|||ANCOVA|||Analysis for PRO C3.||-1.75|-17.7|0.018
72590279|NCT02163226|144712194|OTHER|2 sided p value||||||0.04|||||||Fisher Exact|||Pain Response Rates (CR+PR) at 3 months||||.04
72590280|NCT02163226|144712194|OTHER|2 sided p value||||||0.89|||||||Fisher Exact|||Pain Response Rates (CR+PR) at 6 months||||.89
72590281|NCT02163226|144712194|OTHER|2 sided p value||||||0.07|||||||Fisher Exact|||Pain Response Rates (CR+PR) at 9 months||||.07
72590282|NCT02163226|144712195|OTHER|2 sided p value||||||0.01|||||||Fisher Exact|||Pain response Rates (CR+PR) at 2 weeks||||.01
72590283|NCT02163226|144712195|OTHER|2 sided p value||||||0.15|||||||Fisher Exact|||Pain response Rates (CR+PR) at 1 month||||.15
72414232|NCT03394924|144337651|SUPERIORITY||Least squares mean difference|-6.73||||0.125|TWO_SIDED|95.0|-15.41|1.95|||ANCOVA|||Analysis for PRO C3.||1.95|-15.41|0.125
72414233|NCT03394924|144337652|SUPERIORITY||Least squares mean difference|-0.37||||0|TWO_SIDED|95.0|-0.56|-0.18|||ANCOVA|||||-0.18|-0.56|0.000
72414234|NCT03394924|144337652|SUPERIORITY||Least squares mean difference|-0.33||||0.002|TWO_SIDED|95.0|-0.54|-0.13|||ANCOVA|||||-0.13|-0.54|0.002
72590284|NCT02163226|144712195|OTHER|2 sided p value||||||0.04|||||||Fisher Exact|||Pain response Rates (CR+PR) at 3 months||||.04
72590285|NCT02163226|144712195|OTHER|2 sided p valued||||||0.78|||||||Fisher Exact|||Pain response Rates (CR+PR) at 6 months||||.78
72590286|NCT02163226|144712195|OTHER|2 sided p valued||||||0.04|||||||Fisher Exact|||Pain response Rates (CR+PR) at 9 months||||.04
72590287|NCT02163226|144712195|OTHER|2 sided p valued||||||0.01|||||||Fisher Exact|||Pain response Rates (CR+PR) at 2 weeks||||.01
72590288|NCT02163226|144712195|OTHER|2 sided p value||||||0.15|||||||Fisher Exact|||Pain response Rates (CR+PR) at 1 month||||.15
72590289|NCT02163226|144712195|OTHER|2 sided p value||||||0.04|||||||Fisher Exact|||Pain response Rates (CR+PR) at 3 months||||.04
72590290|NCT02163226|144712195|OTHER|2 sided p value||||||0.78|||||||Fisher Exact|||Pain response Rates (CR+PR) at 6 months||||.78
72590291|NCT02163226|144712195|OTHER|2 sided p value||||||0.04|||||||Fisher Exact|||Pain response Rates (CR+PR) at 9 months||||.04
72590292|NCT00601172|144712227|SUPERIORITY_OR_OTHER||difference in percentage of participants|1.0||||0.7273|TWO_SIDED|95.0|-4.6|6.6||p-value based on normal approximation to the binomial using a pooled Z test.|Pooled Z test||The parameter estimated was difference in percentage of participants with response.|Placebo vs Casopitant 90 mg||6.6|-4.6|0.7273
72590293|NCT00601172|144712228|SUPERIORITY_OR_OTHER||Difference in percentage of participants|1.0||||0.4771|TWO_SIDED|95.0|-1.8|3.8||p-value based on normal approximation to the binomial using a pooled Z test.|Pooled Z test||The parameter estimated was difference in percentage of participants with response.|Placebo vs Casopitant 90 mg||3.8|-1.8|0.4771
72590294|NCT00601172|144712229|SUPERIORITY_OR_OTHER||Difference in percentage of participants|1.0||||0.7273|TWO_SIDED|95.0|-4.6|6.6|||Pooled Z test|p-value based on normal approximation to the binomial using a pooled Z test.|The parameter estimated was difference in percentage of participants with response.|Placebo vs Casopitant 90 mg||6.6|-4.6|0.7273
72590295|NCT00601172|144712230|SUPERIORITY_OR_OTHER||Treatment difference (%)|6.0||||0.0317|TWO_SIDED|95.0|0.5|11.5||p-value based on normal approximation to the binomial using a pooled Z test.|Pooled Z test|||Placebo vs Casopitant 90 mg||11.5|0.5|0.0317
72590296|NCT00601172|144712231|SUPERIORITY_OR_OTHER|||||||0.056|||||||Wilcoxon-rank sum test|||Placebo vs Casopitant 90 mg (0-120 hours)||||0.0560
72590297|NCT00601172|144712231|SUPERIORITY_OR_OTHER|||||||0.0443|||||||Wilcoxon-rank sum test|||Placebo vs Casopitant 90 mg (0-24 hours)||||0.0443
72590298|NCT00601172|144712231|SUPERIORITY_OR_OTHER|||||||0.1709|||||||Wilcoxon-rank sum test|||Placebo vs Casopitant 90 mg (24-120 hours)||||0.1709
72369816|NCT02563067|144250011|SUPERIORITY||Mean Difference (Net)|0.038||||0.824|TWO_SIDED|95.0|-0.048|0.124|||ANCOVA|adjusted p-value, closed testing procedure across the primary and key secondary null hypotheses. Overall type I error rate controlled at two-sided 5%.||||0.124|-0.048|0.824
72590299|NCT00601172|144712232|SUPERIORITY_OR_OTHER||Treatment difference (%)|-1.8||||0.3986|TWO_SIDED|95.0|-5.9|2.3|||Chi-squared|||Placebo vs Casopitant 90 mg (0-120 hours)||2.3|-5.9|0.3986
72590300|NCT00601172|144712232|SUPERIORITY_OR_OTHER||Treatment difference (%)|-0.9||||0.3545|TWO_SIDED|95.0|-2.7|1.0|||Chi-squared|||Placebo vs Casopitant 90 mg (0-24 hours)||1.0|-2.7|0.3545
72590301|NCT00601172|144712232|SUPERIORITY_OR_OTHER||Treatment difference (%)|-1.8||||0.3986|TWO_SIDED|95.0|-5.9|2.3|||Chi-squared|||Placebo vs Casopitant 90 mg (24-120 hours)||2.3|-5.9|0.3986
72590302|NCT00601172|144712233|SUPERIORITY_OR_OTHER||Treament Difference (%)|-0.9||||0.6795|TWO_SIDED|95.0|-5.4|3.5|||Chi-squared|||Placebo vs Casopitant 90 mg (0-120 hours)||3.5|-5.4|0.6795
72590303|NCT00601172|144712233|SUPERIORITY_OR_OTHER||Treament Difference (%)|-0.9||||0.4507|TWO_SIDED|95.0|-3.1|1.4|||Chi-squared|||Placebo vs Casopitant 90 mg (0-24 hours)||1.4|-3.1|0.4507
72590304|NCT00601172|144712233|SUPERIORITY_OR_OTHER||Treament Difference (%)|-0.9||||0.6795|TWO_SIDED|95.0|-5.4|3.5|||Chi-squared|||Placebo vs Casopitant 90 mg (24-120 hours)||3.5|-5.4|0.6795
72590305|NCT00601172|144712234|SUPERIORITY_OR_OTHER||Difference in percentage of participants|2.1||||0.4846|TWO_SIDED|95.0|-3.8|8.0|||Chi-squared||Difference in percentage of participants with response.|Placebo vs Casopitant 90 mg (0-120 hours)||8.0|-3.8|0.4846
72590306|NCT00601172|144712234|SUPERIORITY_OR_OTHER||Difference in percentage of participants|0.8||||0.6101|TWO_SIDED|95.0|-2.3|3.9|||Chi-squared||Difference in percentage of participants with response.|Placebo vs Casopitant 90 mg (0-24 hours)||3.9|-2.3|0.6101
72590307|NCT00601172|144712234|SUPERIORITY_OR_OTHER||Percentage of participants|2.1||||0.4846|TWO_SIDED|95.0|-3.8|8.0|||Chi-squared||Difference in percentage of participants with response.|Placebo vs Casopitant 90 mg (24-120 hours)||8.0|-3.8|0.4846
72369817|NCT02563067|144250012|SUPERIORITY||Rate Ratio|0.82||||0.369|TWO_SIDED|95.0|0.62|1.07|||negative binomial regression model|adjusted p-value, closed testing procedure across the primary and key secondary null hypotheses. Overall type I error rate controlled at two-sided 5%.||||1.07|0.62|0.369
72590308|NCT00601172|144712235|SUPERIORITY_OR_OTHER||Difference in percentage of participants|3.8||||0.1356|TWO_SIDED|95.0|-1.2|8.9|||Chi-squared||The parameter estimated was difference in percentage of participants with response.|Placebo vs Casopitant 90 mg (0-24 hours)||8.9|-1.2|0.1356
72590309|NCT00601172|144712235|SUPERIORITY_OR_OTHER||Difference in percentage of participants|8.1||||0.028|TWO_SIDED|95.0|0.9|15.4|||Chi-squared||The parameter estimated was difference in percentage of participants with response.|Placebo vs Casopitant 90 mg (0-120 hours)||15.4|0.9|0.0280
72590310|NCT00601172|144712235|SUPERIORITY_OR_OTHER||Difference in percentage of participants|8.1||||0.028|TWO_SIDED|95.0|0.9|15.4|||Chi-squared||The parameter estimated was difference in percentage of participants with response.|Placebo vs Casopitant 90 mg (24-120 hours)||15.4|0.9|0.0280
72590311|NCT00601172|144712236|SUPERIORITY_OR_OTHER||Difference in percentage of participants|-0.9||||0.7799|TWO_SIDED|95.0|-7.3|5.5|||Chi-squared||The parameter estimated was difference in percentage of participants with response.|Placebo vs Casopitant 90 mg (0-120 hours)||5.5|-7.3|0.7799
72590312|NCT00601172|144712236|SUPERIORITY_OR_OTHER||Difference in percentage of participants|0.5||||0.7883|TWO_SIDED|95.0|-3.2|4.2|||Chi-squared||The parameter estimated was difference in percentage of participants with response.|Placebo vs Casopitant 90 mg (0-24 hours)||4.2|-3.2|0.7883
72590313|NCT00601172|144712236|SUPERIORITY_OR_OTHER||Difference in percentage of participants|-0.9||||0.7799|TWO_SIDED|95.0|-7.3|5.5|||Chi-squared||The parameter estimated was difference in percentage of participants with response.|Placebo vs Casopitant 90 mg (24-120 hours)||5.5|-7.3|0.7799
72590314|NCT00601172|144712237|SUPERIORITY_OR_OTHER||Difference in percentage of participants|-7.3||||0.0507|TWO_SIDED|95.0|-15.0|0.0|||Chi-squared||The parameter estimated was difference in percentage of participants with response.|Placebo vs Casopitant 90 mg (0-120 hours)||0.0|-15|0.0507
72590315|NCT00601172|144712237|SUPERIORITY_OR_OTHER||Difference in percentage of participants|-4.7||||0.08|TWO_SIDED|95.0|-9.9|0.5|||Chi-squared||The parameter estimated was difference in percentage of participants with response.|Placebo vs Casopitant 90 mg (0-24 hours)||0.5|-9.9|0.0800
72369818|NCT02563067|144250012|SUPERIORITY||Rate Ratio|0.76||||0.348|TWO_SIDED|95.0|0.58|1.0|||negative binomial regression model|adjusted p-value, closed testing procedure across the primary and key secondary null hypotheses. Overall type I error rate controlled at two-sided 5%.||||1.00|0.58|0.348
72590316|NCT00601172|144712237|SUPERIORITY_OR_OTHER||Difference in percentage of participants|-7.3||||0.0507|TWO_SIDED|95.0|-15.0|0.0|||Chi-squared||The parameter estimated was difference in percentage of participants with response.|Placebo vs Casopitant 90 mg (24-120 hours)||0.0|-15|0.0507
72590317|NCT00601172|144712238|SUPERIORITY_OR_OTHER||Difference in percentage of participants|-2.6|||||TWO_SIDED|97.5|-9.9|4.7|||||The parameter estimated was difference in percentage of participants with response.|Nausea Impact: Placebo vs. Casopitant 90 mg; Cycle 1 (0-120 hours)||4.7|-9.9|
72590318|NCT00601172|144712238|SUPERIORITY_OR_OTHER||Difference in percentage of participants|0.7||||||97.5|-5.2|6.6|||||The parameter estimated was difference in percentage of participants with response.|Vomiting Impact: Placebo vs. Casopitant 90 mg; Cycle 1 (0-120 hours)||6.6|-5.2|
72590319|NCT00601172|144712239|SUPERIORITY_OR_OTHER|||||||0.1572|||||||Chi-squared|||Placebo vs. Casopitant 90 mg: (0-120 hours) in Cycle 1||||0.1572
72590320|NCT00601172|144712239|SUPERIORITY_OR_OTHER|||||||0.2908|||||||Chi-squared|||Placebo vs. Casopitant 90 mg: (0-24 hours) in Cycle 1||||0.2908
72590321|NCT00601172|144712239|SUPERIORITY_OR_OTHER|||||||0.1572|||||||Chi-squared|||Placebo vs. Casopitant 90 mg: (24-120 hours) in Cycle 1||||0.1572
72590322|NCT01669174|144712277|SUPERIORITY_OR_OTHER||Mean Difference (Net)|106.1|||<|0.001|TWO_SIDED|90.0|104.64|107.58|||ANCOVA|||Week 4||107.58|104.64|<0.001
72590323|NCT01669174|144712277|SUPERIORITY_OR_OTHER||Median Difference (Net)|107.75|||<|0.001|TWO_SIDED|90.0|106.18|109.35|||ANCOVA|||Week 8||109.35|106.18|<0.001
72590324|NCT01669174|144712277|SUPERIORITY_OR_OTHER||Median Difference (Net)|108.63|||<|0.001|TWO_SIDED|90.0|106.31|111.0|||ANCOVA|||Week 16||111.00|106.31|<0.001
72590325|NCT01669174|144712277|SUPERIORITY_OR_OTHER||Median Difference (Net)|106.63|||<|0.001|TWO_SIDED|90.0|104.39|108.93|||ANCOVA|||Week 24||108.93|104.39|<0.001
72369819|NCT02563067|144250013|SUPERIORITY||Mean Difference (Net)|0.07||||0.824|TWO_SIDED|95.0|-0.07|0.21|||ANCOVA|adjusted p-value, closed testing procedure across the primary and key secondary null hypotheses. Overall type I error rate controlled at two-sided 5%.||||0.21|-0.07|0.824
72590326|NCT05537441|144712282|SUPERIORITY||Percent Difference|0.64||||0.216|TWO_SIDED||||||2 proportion Z-test|||||||0.216
72590327|NCT05537441|144712283|SUPERIORITY||Percent Difference|-0.61||||0.34|TWO_SIDED||||||2 proportion Z-test|||Previously vaccinated||||0.34
72590328|NCT05537441|144712283|SUPERIORITY||Percent Difference|-0.45||||0.247|TWO_SIDED||||||2 proportion Z-test|||Previously unvaccinated||||0.247
72369820|NCT02563067|144250013|SUPERIORITY||Mean Difference (Net)|0.12||||0.824|TWO_SIDED|95.0|-0.02|0.26|||ANCOVA|adjusted p-value, closed testing procedure across the primary and key secondary null hypotheses. Overall type I error rate controlled at two-sided 5%.||||0.26|-0.02|0.824
72369821|NCT02563067|144250014|SUPERIORITY||Mean Difference (Net)|-0.12||||0.824|TWO_SIDED|95.0|-0.28|0.03|||ANCOVA|adjusted p-value, closed testing procedure across the primary and key secondary null hypotheses. Overall type I error rate controlled at two-sided 5%.||||0.03|-0.28|0.824
72369822|NCT02563067|144250014|SUPERIORITY||Mean Difference (Net)|-0.07||||0.824|TWO_SIDED|95.0|-0.23|0.08|||ANCOVA|adjusted p-value, closed testing procedure across the primary and key secondary null hypotheses. Overall type I error rate controlled at two-sided 5%.||||0.08|-0.23|0.824
72369823|NCT02563067|144250015|SUPERIORITY||Mean Difference (Net)|0.05||||0.369|TWO_SIDED|95.0|-0.019|0.119|||ANCOVA|adjusted p-value, closed testing procedure across the primary and key secondary null hypotheses. Overall type I error rate controlled at two-sided 5%.||||0.119|-0.019|0.369
72369824|NCT02563067|144250015|SUPERIORITY||Mean Difference (Net)|0.061||||0.595|TWO_SIDED|95.0|-0.008|0.13|||ANCOVA|adjusted p-value, closed testing procedure across the primary and key secondary null hypotheses. Overall type I error rate controlled at two-sided 5%.||||0.130|-0.008|0.595
72369825|NCT00839319|144250017|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||ANOVA|Correlations between serum hormone levels and IT hormones, and between IT hormones were performed on 23 subjects in 4 groups using Spearmen technique.||||||<0.05
72590329|NCT00614523|144712298|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.83||||0.13|TWO_SIDED|95.0|0.66|1.05|||Anderson-Gill model|Anderson-Gill model using the model-based variance estimate and stratified by the randomization stratification factors|Romiplostim /Placebo|||1.05|0.66|0.13
72369826|NCT00243269|144250047|SUPERIORITY_OR_OTHER|||||||0.932||95.0|||||ANOVA|||The primary analyses consisted of calculating means and standard deviations on nausea for the four study arms to generate an effect size estimate for a later R01. We also planned to use a 2 x 2 (i.e., two levels of expectancy CDs and two levels of expectancy handouts) full factorial analysis of variance (ANOVA) to examine the efficacy of these two methods of expectancy enhancement in reducing Average Nausea as well as any interaction effects.||||0.932
72590330|NCT00614523|144712299|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.766|||<|0.001|TWO_SIDED|95.0|0.66|0.88|||Poisson regression model|Poisson regression model with treatment and stratification factors as covariates.|Romiplostim /Placebo|||0.88|0.66|<0.001
72590331|NCT00614523|144712300|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.922||||0.026|TWO_SIDED|95.0|0.86|0.99|||Poisson regression model|Poisson regression model with treatment and stratification factors as covariates.|Romiplostim /Placebo|||0.99|0.86|0.026
72590332|NCT00614523|144712301|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.739|||<|0.001|TWO_SIDED|95.0|0.68|0.8|||Poisson Regression model|Poisson regression model with treatment and stratification factors as covariates|Romiplostim /Placebo|||0.8|0.68|<0.001
72590333|NCT00614523|144712302|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|15.6|||<|0.001|TWO_SIDED|95.0|4.7|51.8|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test controlling for stratification factors.|Romiplostim /Placebo|||51.8|4.7|<0.001
72590334|NCT00614523|144712303|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|1.402||||0.032|TWO_SIDED|95.0|1.03|1.91|||Poisson regression model|Poisson regression model with treatment and stratification factors as covariates|Romiplostim /Placebo|||1.91|1.03|0.032
72590335|NCT00614523|144712307|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.639|||<|0.001|TWO_SIDED|95.0|0.57|0.71|||Poisson regression model|Poisson regression model with treatment and stratification factors as covariates|Romiplostim /Placebo|||0.71|0.57|<0.001
72590336|NCT02461524|144712319|OTHER||Percentage|2.9|||<|0.001|ONE_SIDED|97.5||8.7|||Exact binomial test|||"The primary safety endpoint was tested against a predetermined safety Performance Goal (PG) using the following statistical hypotheses:~H0: p ≥ 20% vs. H1: p \< 20% where p is the proportion of subjects experiencing a Major Adverse Event (MAE) within 30 days of the index procedure in the target population of subjects treated with the Endurant Evo Abdominal Aortic Aneurysm (AAA) Stent graft system and 20% is the safety PG."||8.7||<0.001
72590337|NCT02461524|144712320|OTHER|Single-arm study with a hypothesis test comparing to performance goal|Percentage|100.0||||0.001|ONE_SIDED|95.0|95.8||||Based on exact binomial distribution|||"The primary effectiveness endpoint was tested against a predetermined effectiveness PG using following statistical hypotheses:~H0: q ≤ 80% vs. H1: q \> 80% where q is the proportion of subjects who have a successful aneurysm treatment in the target population of subjects treated with the Endurant Evo AAA Stent graft system and 80% is the effectiveness PG."|||95.8|0.001
72590338|NCT00765895|144712341|SUPERIORITY_OR_OTHER_LEGACY|||||||0.86|||||||Mantel Haenszel|Stratified by clinic||||||0.86
72590339|NCT04481191|144712343|NON_INFERIORITY|Non-inferiority was declared when the lower bound of the 95% CI for the difference in percentages (Concomitant-use Group - Staggered-use Group) being \> -10 percentage points (one-sided p-value \< 0.025).|Mean Difference (Final Values)|-1.1|||<|0.001|TWO_SIDED|95.0|-4.0|0.9||One-sided p-value|Unstratified Miettinen & Nurminen method|||Difference indicates Concomitant-use Group % - Staggered-use Group %||0.9|-4.0|< 0.001
72369827|NCT00243269|144250048|SUPERIORITY_OR_OTHER|||||||0.84||95.0|||||ANOVA|||ANOVA to compare means of the four groups was used.||||0.84
72369828|NCT01396447|144250129|SUPERIORITY||Mean Difference (Final Values)|-1.9||||0.1292|TWO_SIDED|95.0|-4.3|0.5||The analysis included treatment group, pooled study center, visit, and treatment-group-by-visit interaction as fixed effects and the baseline value and baseline value-by-visit interaction as covariates.|Repeated measures mixed-effects model||Cariprazine 0.75 mg vs Placebo|||0.5|-4.3|0.1292
72369829|NCT01396447|144250129|SUPERIORITY||Mean Difference (Final Values)|-4.0||||0.001|TWO_SIDED|95.0|-6.3|-1.6||The analysis included treatment group, pooled study center, visit, and treatment-group-by-visit interaction as fixed effects and the baseline value and baseline value-by-visit interaction as covariates.|Repeated measures mixed-effects model||Cariprazine 1.5 mg vs Placebo|||-1.6|-6.3|0.0010
72369830|NCT01396447|144250129|SUPERIORITY||Mean Difference (Final Values)|-2.5||||0.0374|TWO_SIDED|95.0|-4.9|-0.1||The analysis included treatment group, pooled study center, visit, and treatment-group-by-visit interaction as fixed effects and the baseline value and baseline value-by-visit interaction as covariates.|Repeated measures mixed-effects model||Cariprazine 3.0 mg vs Placebo|||-0.1|-4.9|0.0374
72369831|NCT01396447|144250130|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.3025|TWO_SIDED|95.0|-0.4|0.1|||Repeated measures mixed-effects model||Cariprazine 0.75 mg vs Placebo|The analysis included treatment group, pooled study center, visit, and treatment-group-by-visit interaction as fixed effects and the baseline value and baseline value-by-visit interaction as covariates.||0.1|-0.4|0.3025
72369832|NCT01396447|144250130|SUPERIORITY||Mean Difference (Final Values)|-0.4||||0.0044|TWO_SIDED|95.0|-0.6|-0.2|||Repeated measures mixed-effects model||Cariprazine 1.5 mg vs Placebo|The analysis included treatment group, pooled study center, visit, and treatment-group-by-visit interaction as fixed effects and the baseline value and baseline value-by-visit interaction as covariates.||-0.2|-0.6|0.0044
72414235|NCT03394924|144337653|SUPERIORITY||Least squares mean difference|-0.35||||0.026|TWO_SIDED|95.0|-0.65|-0.04|||ANCOVA|||||-0.04|-0.65|0.026
72414236|NCT03394924|144337653|SUPERIORITY||Least squares mean difference|-0.26||||0.104|TWO_SIDED|95.0|-0.57|0.05|||ANCOVA|||||0.05|-0.57|0.104
72590340|NCT04481191|144712343|NON_INFERIORITY|Non-inferiority was declared when the lower bound of the 95% CI for the difference in percentages (Concomitant-use Group - Staggered-use Group) being \> -10 percentage points (one-sided p-value \< 0.025).|Mean Difference (Final Values)|-1.1|||<|0.001|TWO_SIDED|95.0|-4.3|1.5||One-sided p-value|Unstratified Miettinen & Nurminen method|||Difference indicates Concomitant-use Group % - Staggered-use Group %||1.5|-4.3|< 0.001
72590341|NCT04481191|144712343|NON_INFERIORITY|Non-inferiority was declared when the lower bound of the 95% CI for the difference in percentages (Concomitant-use Group - Staggered-use Group) being \> -10 percentage points (one-sided p-value \< 0.025).|Mean Difference (Final Values)|0.5|||<|0.001|TWO_SIDED|95.0|-1.6|3.0||One-sided p-value|Unstratified Miettinen & Nurminen method|||Difference indicates Concomitant-use % - Staggered-use %||3.0|-1.6|< 0.001
72590342|NCT02002533|144712423|SUPERIORITY||||||>|0.9999|||||||exact binomial test|The percentage is greater than or equal to 40%.||||||>0.9999
72590343|NCT02002533|144712424|SUPERIORITY|||||||0.735|||||||exact binomial test|||||||0.7350
72590344|NCT02002533|144712425|SUPERIORITY||Mean Difference (Final Values)|0.8075|STANDARD_ERROR_OF_MEAN|0.0845|<|0.0001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.0001
72414237|NCT03394924|144337654|SUPERIORITY||Least squares mean difference|6.81||||0.757|TWO_SIDED|95.0|-37.17|50.78|||ANCOVA|||Analysis for fibrinogen.||50.78|-37.17|0.757
72590345|NCT02002533|144712426|SUPERIORITY||Mean Difference (Final Values)|-1.64|STANDARD_ERROR_OF_MEAN|1.21||0.1808|TWO_SIDED||||||ANCOVA||The estimated value is BBT minus HEAL.|||||0.1808
72590346|NCT02002533|144712427|SUPERIORITY||Mean Difference (Final Values)|-1.08|STANDARD_ERROR_OF_MEAN|0.73||0.14|TWO_SIDED||||||ANCOVA||Estimated value is BBT minus HEAL.|||||0.14
72590347|NCT02002533|144712428|SUPERIORITY||Mean Difference (Final Values)|0.404|STANDARD_ERROR_OF_MEAN|0.137||0.005|TWO_SIDED||||||ANCOVA|For baseline of 0.7.||||||0.005
72590348|NCT02002533|144712428|SUPERIORITY||Mean Difference (Final Values)|0.077|STANDARD_ERROR_OF_MEAN|0.045||0.092|TWO_SIDED|||||At baseline 1.3.|ANCOVA|||||||0.092
72590349|NCT02002533|144712428|SUPERIORITY||Mean Difference (Final Values)|-0.032|STANDARD_ERROR_OF_MEAN|0.053||0.556|TWO_SIDED|||||At baseline of 1.5.|ANCOVA|||||||0.556
72590350|NCT02002533|144712428|SUPERIORITY||Mean Difference (Final Values)|-6.24|STANDARD_ERROR_OF_MEAN|0.221||0.007|TWO_SIDED|||||Grouped by baseline interaction.|ANCOVA||The estimated value is grouped by baseline interaction parameter.|||||0.007
72414238|NCT03394924|144337654|SUPERIORITY||Least squares mean difference|31.77||||0.174|TWO_SIDED|95.0|-14.42|77.97|||ANCOVA|||Analysis for fibrinogen.||77.97|-14.42|0.174
72590351|NCT02002533|144712429|SUPERIORITY|||||||0|||||||ANCOVA|||||||0.000
72590352|NCT02002533|144712430|SUPERIORITY|||||||0.295|||||||ANCOVA|||||||0.295
72590353|NCT02002533|144712431|SUPERIORITY|||||||0.573|||||||ANCOVA|||||||0.573
72590354|NCT02002533|144712432|SUPERIORITY||Mean Difference (Final Values)|-6.502|STANDARD_ERROR_OF_MEAN|2.558||0.015|TWO_SIDED||||||ANCOVA||Group difference (BBT - HEAL) in mean post-pre change.|||||0.015
72590355|NCT02002533|144712432|SUPERIORITY||Mean Difference (Final Values)|-1.723|STANDARD_ERROR_OF_MEAN|1.007||0.094|TWO_SIDED||||||ANCOVA||Group difference (BBT - HEAL) in mean post-pre change.|||||0.094
72590356|NCT02002533|144712432|SUPERIORITY||Mean Difference (Final Values)|3.75|STANDARD_ERROR_OF_MEAN|2.326||0.114|TWO_SIDED||||||ANCOVA||Group difference (BBT - HEAL) in mean post-pre change.|||||0.114
72590357|NCT02002533|144712432|SUPERIORITY||Mean Difference (Final Values)|0.911|STANDARD_ERROR_OF_MEAN|0.4||0.027|TWO_SIDED||||||ANCOVA||This is an arm by baseline interaction parameter.|||||0.027
72590358|NCT00722566|144712437|NON_INFERIORITY_OR_EQUIVALENCE|Assuming ORRs are 35.5% for both SC and IV, one-sided alpha level of 0.025, and approximately 80% power, approximately 216 subjects (144 SC:72 IV) are needed to show non-inferiority of SC to IV VELCADE.|ORR_SQ - 0.6 ORR_IV|16.8||||0.00201|TWO_SIDED|95.0|6.1|27.1|||Farrrington and Manning|CONOR P. FARRINGTON AND GODFREY MANNING STATISTICS IN MEDICINE, VOL. 9, 1447-1454(1990).||In this trial, non-inferiority is defined as retaining 60% of the IV (active control) treatment effect as measured by ORR. The non-inferiority hypothesis can be stated as: H0: ORRSC - 0.60 ORRIV \<0 vs. H1: ORRSC - 0.60 ORRIV ≥0 (non-inferiority).||27.1|6.1|0.00201
72590359|NCT04984278|144712439|SUPERIORITY||Combined least mean square difference|-0.29|STANDARD_ERROR_OF_MEAN|0.092|=|0.0048|TWO_SIDED|95.0|-0.48|-0.1|||Mixed Models Analysis|||||-0.10|-0.48|=0.0048
72590360|NCT01895270|144712466|SUPERIORITY||Slope|0.34|STANDARD_ERROR_OF_MEAN|0.42||0.42|TWO_SIDED||||||Mixed Models Analysis|||||||.42
72590361|NCT02651155|144712467|SUPERIORITY_OR_OTHER||Median Values of CI|1.0||||0.003|TWO_SIDED|95.0|0.1|1.0|||Van Elteren Test|SBM was analyzed using Van Elteren Test stratified by center. Centers with less participants were pooled based on geographical proximity.|CI was estimated by inverting the hypothesis test.|||1.0|0.1|0.003
72414239|NCT03394924|144337654|SUPERIORITY||Least squares mean difference|-0.98||||0.378|TWO_SIDED|95.0|-3.18|1.23|||ANCOVA|||Analysis for CRP.||1.23|-3.18|0.378
72414240|NCT03394924|144337654|SUPERIORITY||Least squares mean difference|-3.1||||0.008|TWO_SIDED|95.0|-5.38|-0.83|||ANCOVA|||Analysis for CRP.||-0.83|-5.38|0.008
72414241|NCT03394924|144337655|SUPERIORITY||Least squares mean difference|0.34||||0.841|TWO_SIDED|95.0|-3.07|3.76|||ANCOVA|||Analysis for IL6.||3.76|-3.07|0.841
72414242|NCT03394924|144337655|SUPERIORITY||Least squares mean difference|-2.49||||0.163|TWO_SIDED|95.0|-6.01|1.04|||ANCOVA|||Analysis for IL6.||1.04|-6.01|0.163
72414243|NCT03394924|144337655|SUPERIORITY||Least squares mean difference|-0.53||||0.03|TWO_SIDED|95.0|-1.02|-0.05|||ANCOVA|||Analysis for TNF α.||-0.05|-1.02|0.03
72590362|NCT01098500|144712556|SUPERIORITY_OR_OTHER||Prevalence percentage|2.2|||||TWO_SIDED|95.0|0.9|3.5|||||Prevalence percentage is the number of patients with an ALT \>=3 times ULN divided by all patients that were tested at baseline (30 days prior to initiation of TKI drug).|||3.5|0.9|
72590363|NCT01098500|144712557|SUPERIORITY_OR_OTHER||Incidence Rate (IR)|6.2|||||TWO_SIDED|95.0|3.3|9.0|||||Incidence rate (IR) is the number of patients with an ALT \>=3 times ULN after initiation of TKI divided by person time contributed by all patients with normal ALT (\<1 times ULN) at baseline. IR expressed per 100 person years.|||9.0|3.3|
72590364|NCT01098500|144712558|SUPERIORITY_OR_OTHER||Prevalence percentage|0.4|||||TWO_SIDED|95.0|0.1|1.4|||||Prevalence percentage is the number of patients with Hy's Law divided by all patients that were tested at baseline (30 days prior to initiation of TKI drug).|||1.4|0.1|
72590365|NCT01098500|144712559|SUPERIORITY_OR_OTHER||Incidence Rate (IR)|0.4|||||TWO_SIDED|95.0|0.0|2.0|||||Incidence rate (IR) is the number of patients with Hy's Law after initiation of TKI divided by person time contributed by all patients with normal ALT, AST, ALP, and BIL (\< 1 times ULN) at baseline. IR is expressed per 100 person years.|||2.0|0.0|
72590366|NCT01647516|144712602|SUPERIORITY||Odds Ratio (OR)|3.262||||0.0482|TWO_SIDED|95.0|0.969|10.984|||Cochran-Mantel-Haenszel|Stratified by prior anti-tumor necrosing factor (anti-TNF) therapy experience, (yes or no).||||10.984|0.969|0.0482
72590367|NCT01647516|144712602|SUPERIORITY||Odds Ratio (OR)|2.5||||0.1422|TWO_SIDED|95.0|0.722|8.661|||Cochran-Mantel-Haenszel|Stratified by prior anti-tumor necrosing factor (anti-TNF) therapy experience, (yes or no).||||8.661|0.722|0.1422
72590368|NCT01647516|144712603|SUPERIORITY||Odds Ratio (OR)|2.158||||0.0207|TWO_SIDED|95.0|1.093|4.263|||Cochran-Mantel-Haenszel|Stratified by prior anti-tumor necrosing factor (anti-TNF) therapy experience, (yes or no).||||4.263|1.093|0.0207
72590369|NCT01647516|144712603|SUPERIORITY||Odds Ratio (OR)|1.947||||0.0648|TWO_SIDED|95.0|0.961|3.946|||Cochran-Mantel-Haenszel|Stratified by prior anti-tumor necrosing factor (anti-TNF) therapy experience, (yes or no).||||3.946|0.961|0.0648
72590370|NCT01647516|144712604|SUPERIORITY|||||||0.0042|||||||ANCOVA|The analysis of covariance model, adjusting for baseline Mayo score and prior anti-TNF (yes or no).||||||0.0042
72590371|NCT01647516|144712604|SUPERIORITY|||||||0.1415|||||||ANCOVA|The analysis of covariance model, adjusting for baseline Mayo score and prior anti-TNF (yes or no).||||||0.1415
72590372|NCT01647516|144712605|SUPERIORITY||Odds Ratio (OR)|3.861||||0.0023|TWO_SIDED|95.0|1.572|9.484|||Cochran-Mantel-Haenszel|Stratified by prior anti-TNF therapy experience, (yes or no).||||9.484|1.572|0.0023
72590373|NCT01647516|144712605|SUPERIORITY||Odds Ratio (OR)|2.647||||0.0348|TWO_SIDED|95.0|1.058|6.621|||Cochran-Mantel-Haenszel|Stratified by prior anti-TNF therapy experience, (yes or no).||||6.621|1.058|0.0348
72590374|NCT01647516|144712606|SUPERIORITY||Odds Ratio (OR)|4.332||||0.0108|TWO_SIDED|95.0|1.323|14.186|||Cochran-Mantel-Haenszel|Stratified by prior anti-TNF therapy experience, (yes or no).||||14.186|1.323|0.0108
72590375|NCT01647516|144712606|SUPERIORITY||Odds Ratio (OR)|5.443||||0.0021|TWO_SIDED|95.0|1.706|17.365|||Cochran-Mantel-Haenszel|Stratified by prior anti-TNF therapy experience, (yes or no).||||17.365|1.706|0.0021
72590376|NCT01647516|144712607|SUPERIORITY|Stratified by prior anti-TNF therapy experience, (yes or no).|Odds Ratio (OR)|4.03||||0.0002|TWO_SIDED|95.0|1.871|8.678|||Cochran-Mantel-Haenszel|||||8.678|1.871|0.0002
72590377|NCT01647516|144712607|SUPERIORITY||Odds Ratio (OR)|2.154||||0.0571|TWO_SIDED|95.0|0.974|4.763|||Cochran-Mantel-Haenszel|Stratified by prior anti-TNF therapy experience, (yes or no).||||4.763|0.974|0.0571
72590378|NCT01647516|144712608|SUPERIORITY||Odds Ratio (OR)|3.557||||0.0046|TWO_SIDED|95.0|1.444|8.762|||Cochran-Mantel-Haenszel|Stratified by prior anti-TNF therapy experience, (yes or no).||||8.762|1.444|0.0046
72590379|NCT01647516|144712608|SUPERIORITY||Odds Ratio (OR)|3.428||||0.0064|TWO_SIDED|95.0|1.384|8.494|||Cochran-Mantel-Haenszel|Stratified by prior anti-TNF therapy experience, (yes or no).||||8.494|1.384|0.0064
72590380|NCT00750139|144712645|SUPERIORITY_OR_OTHER|||||||0.01||||||The first primary efficacy analyses will use the Cochran-Mantel-Haenszel (CMH) test after stratification by pooled clinical site. The test will be conducted with the FAS at a one-sided level of significance of α = 0.025.|Cochran-Mantel-Haenszel|||"The first primary efficacy hypotheses tests are:~H01: p1 ≤ p01 vs. H1: p1 \> p01 where p01 and p1 denote the proportions of complete cure in the placebo 2wks and NAFT-500 groups, respectively."||||0.010
72590381|NCT00750139|144712645|SUPERIORITY_OR_OTHER|||||||0.001||95.0||||The second primary efficacy analyses will use the Cochran-Mantel-Haenszel (CMH) test after stratification by pooled clinical site. The test will be conducted with the FAS at a one-sided level of significance of α = 0.025|Cochran-Mantel-Haenszel|||"The second primary efficacy hypotheses tests are:~H02: p2 ≤ P02 vs. H2: P2 \> p02 where p02 and p2 are denote proportions of complete cure in the placebo 4wks and Naftin 1% groups, respectively"||||0.001
72590382|NCT03681990|144712673|OTHER|Mixed Model ANOVA with subject as a random effect.||||||0.34||||||F test|ANOVA|||||||0.34
72590383|NCT02091375|144712682|SUPERIORITY||Median Difference (Final Values)|-22.79||||0.0123|TWO_SIDED|95.0|-41.06|-5.43|||Wilcoxon rank-sum test||Calculated using the Hodges-Lehmann approach.|||-5.43|-41.06|0.0123
72590384|NCT02091375|144712683|SUPERIORITY||Odds Ratio (OR)|2.0||||0.0784|TWO_SIDED|95.0|0.93|4.3|||Cochran-Mantel-Haenszel|Stratified by age group (2-5 years, 6-12 years, and 13-18 years).||||4.30|0.93|0.0784
72590385|NCT04507256|144712750|OTHER|Bioavailability|Ratio of geometric mean AUCinf|68.69|||||||||||||The bioavailability of AZD7442 Dose 1 administered by IM was, calculated as the ratio of geometric mean AUCinf after IM to IV, for mAb AZD8895.|Bioavailability of AZD8895 at the end of study (Day 361)||||
72590386|NCT04507256|144712750|OTHER|Bioavailability|Ratio of geometric mean AUCinf|65.02|||||||||||||The bioavailability of AZD7442 Dose 1 administered by IM was, calculated as the ratio of geometric mean AUCinf after IM to IV, for mAb AZD1061.|Bioavailability of AZD1061 at the end of study (Day 361)||||
72590387|NCT03330262|144712767|SUPERIORITY|||||||0.018|||||||Mixed Models Analysis|||||||0.018
72590388|NCT03330262|144712768|OTHER|Ho: mean change = 0||||||0.006|||||||Mixed Models Analysis|||||||0.006
72590389|NCT03330262|144712768|OTHER|Ho: mean change = 0||||||0.869|||||||Mixed Models Analysis|||||||0.869
72590390|NCT03330262|144712769|SUPERIORITY|||||||0.448|||||||Mixed Models Analysis|||||||0.448
72590391|NCT03330262|144712770|OTHER|This test evaluated whether the change in ABC was significant for the BALCAP condition##. Ho: mean = 0||||||0.273|||||||Mixed Models Analysis|||||||0.273
72590392|NCT03330262|144712770|OTHER|This test evaluated if the change in ABC score was significant for the control group.||||||0.796|||||||Mixed Models Analysis|||||||0.796
72590393|NCT03330262|144712771|OTHER|Ho: Mean change in score = 0||||||0.189|||||||Mixed Models Analysis|||||||0.189
72590394|NCT03330262|144712771|OTHER|Ho: mean change = 0||||||0.713|||||||Mixed Models Analysis|||||||0.713
72590395|NCT03886519|144712792|SUPERIORITY||Odds Ratio (OR)|0.73||||0.07|TWO_SIDED|95.0|0.52|1.03||The a priori threshold for statistical significance is \<0.05.|Regression, Logistic|Adjusted for correlation between 2 eyes of a participant and baseline trichiasis severity.||||1.03|0.52|0.07
72590396|NCT04964544|144712801|OTHER||Percentage|90.7|||||TWO_SIDED|95.0|88.9|92.3|||||Proportion of participants|Proportion of participants with overall correct initial TASS assessment, with mitigations, worst case imputation (Self-Selection Population)||92.3|88.9|
72590397|NCT04964544|144712802|OTHER||Percentage|98.1|||||TWO_SIDED|95.0|97.1|98.8|||||Proportion of participants|Proportion of participants with overall correct final TASS assessment, with mitigations, worst case imputation (Per Protocol Population)||98.8|97.1|
72590398|NCT04964544|144712803|OTHER||Mean percent change from paseline|-35.48|||||TWO_SIDED|95.0|-36.63|-34.33||||||||-34.33|-36.63|
72590399|NCT01899742|144712820|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.088|||<|0.001|TWO_SIDED|95.0|0.045|0.131|||Mixed Models Analysis|||||0.131|0.045|<0.001
72590400|NCT01899742|144712821|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.073||||0.004|TWO_SIDED|95.0|0.024|0.122|||Mixed Models Analysis|||||0.122|0.024|0.004
72590401|NCT02195310|144712882|SUPERIORITY|||||||0.7007|||||||Fisher Exact Test (2-sided)|||||||0.7007
72590402|NCT01154088|144712883|NON_INFERIORITY|Criterion for non-inferiority: For each serogroup separately, the lower limit (LL) of the 2-sided standardised asymptotic 95% confidence interval (CI) for the group difference (Nimenrix-A Group minus Mencevax Group) in the percentage of subjects with bactericidal vaccine response would be greater than or equal to (≥) the pre-defined clinical limit of -10%.|Difference in vaccine response rate|5.42|||||TWO_SIDED|95.0|-1.41|12.25||||||Demonstration of the non-inferiority of the vaccine response induced by Nimenrix conjugate vaccine (Nimenrix Lot A) when compared to the licensed Mencevax for Neisseria meningitidis (N. meningitidis) serogroups A as measured by serum bactericidal antibodies using baby rabbit complement (rSBA) at GSK.||12.25|-1.41|
72590403|NCT01154088|144712883|NON_INFERIORITY|Criterion for non-inferiority: For each serogroup separately, the lower limit (LL) of the 2-sided standardised asymptotic 95% confidence interval (CI) for the group difference (Nimenrix-A Group minus Mencevax Group) in the percentage of subjects with bactericidal vaccine response would be greater than or equal to (≥) the pre-defined clinical limit of -10%.|Difference in vaccine response rate|-0.41|||||TWO_SIDED|95.0|-4.11|3.25||||||Demonstration of the non-inferiority of the vaccine response induced by Nimenrix conjugate vaccine (Nimenrix Lot A) when compared to the licensed Mencevax for Neisseria meningitidis (N. meningitidis) serogroups C as measured by serum bactericidal antibodies using baby rabbit complement (rSBA) at GSK.||3.25|-4.11|
72590404|NCT01154088|144712883|NON_INFERIORITY|Criterion for non-inferiority: For each serogroup separately, the lower limit (LL) of the 2-sided standardised asymptotic 95% confidence interval (CI) for the group difference (Nimenrix-A Group minus Mencevax Group) in the percentage of subjects with bactericidal vaccine response would be greater than or equal to (≥) the pre-defined clinical limit of -10%.|Difference in vaccine response rate|6.83|||||TWO_SIDED|95.0|3.28|10.78||||||Demonstration of the non-inferiority of the vaccine response induced by Nimenrix conjugate vaccine (Nimenrix Lot A) when compared to the licensed Mencevax for Neisseria meningitidis (N. meningitidis) serogroups W-135 as measured by serum bactericidal antibodies using baby rabbit complement (rSBA) at GSK.||10.78|3.28|
72590405|NCT01154088|144712883|NON_INFERIORITY|Criterion for non-inferiority: For each serogroup separately, the lower limit (LL) of the 2-sided standardised asymptotic 95% confidence interval (CI) for the group difference (Nimenrix-A Group minus Mencevax Group) in the percentage of subjects with bactericidal vaccine response would be greater than or equal to (≥) the pre-defined clinical limit of -10%.|Difference in vaccine response rate|7.02|||||TWO_SIDED|95.0|2.63|11.58||||||Demonstration of the non-inferiority of the vaccine response induced by Nimenrix conjugate vaccine (Nimenrix Lot A) when compared to the licensed Mencevax for Neisseria meningitidis (N. meningitidis) serogroups Y as measured by serum bactericidal antibodies using baby rabbit complement (rSBA) at GSK.||11.58|2.63|
72590406|NCT01154088|144712884|NON_INFERIORITY|Criterion for non-inferiority: Non-inferiority of Nimenrix Lot B vs. Nimenrix Lot A in terms of non-inferiority would be demonstrated if the upper limit (UL) of the 2-sided 95% CIs on the rSBA GMT ratios (GMTs of Nimenrix Lot B over the GMTs of the Nimenrix Lot A) would be below (\<) a limit of 2-fold for antibodies against all meningococcal serogroups.|Adjusted GMT ratio|1.04|||||TWO_SIDED|95.0|0.92|1.17||||||Demonstration of the comparability of the immunogenicity of Lot A to Lot B of Nimenrix conjugate vaccine with respect to rSBA geometric mean titres (GMTs) for N. meningitidis serogroups A, 1 month after vaccination as measured at GSK.||1.17|0.92|
72590407|NCT01154088|144712884|NON_INFERIORITY|Criterion for non-inferiority: Non-inferiority of Nimenrix Lot B vs. Nimenrix Lot A in terms of non-inferiority would be demonstrated if the upper limit (UL) of the 2-sided 95% CIs on the rSBA GMT ratios (GMTs of Nimenrix Lot B over the GMTs of the Nimenrix Lot A) would be below (\<) a limit of 2-fold for antibodies against all meningococcal serogroups.|Adjusted GMT ratio|1.15|||||TWO_SIDED|95.0|0.96|1.37||||||Demonstration of the comparability of the immunogenicity of Lot A to Lot B of Nimenrix conjugate vaccine with respect to rSBA geometric mean titres (GMTs) for N. meningitidis serogroups C, 1 month after vaccination as measured at GSK.||1.37|0.96|
72590408|NCT01154088|144712884|NON_INFERIORITY|Criterion for non-inferiority: Non-inferiority of Nimenrix Lot B vs. Nimenrix Lot A in terms of non-inferiority would be demonstrated if the upper limit (UL) of the 2-sided 95% CIs on the rSBA GMT ratios (GMTs of Nimenrix Lot B over the GMTs of the Nimenrix Lot A) would be below (\<) a limit of 2-fold for antibodies against all meningococcal serogroups.|Adjusted GMT ratio|0.91|||||TWO_SIDED|95.0|0.8|1.04||||||Demonstration of the comparability of the immunogenicity of Lot A to Lot B of Nimenrix conjugate vaccine with respect to rSBA geometric mean titres (GMTs) for N. meningitidis serogroups W-135, 1 month after vaccination as measured at GSK.||1.04|0.8|
72590409|NCT01154088|144712884|NON_INFERIORITY|Criterion for non-inferiority: Non-inferiority of Nimenrix Lot B vs. Nimenrix Lot A in terms of non-inferiority would be demonstrated if the upper limit (UL) of the 2-sided 95% CIs on the rSBA GMT ratios (GMTs of Nimenrix Lot B over the GMTs of the Nimenrix Lot A) would be below (\<) a limit of 2-fold for antibodies against all meningococcal serogroups.|Adjusted GMT ratio|0.88|||||TWO_SIDED|95.0|0.78|0.99||||||Demonstration of the comparability of the immunogenicity of Lot A to Lot B of Nimenrix conjugate vaccine with respect to rSBA geometric mean titres (GMTs) for N. meningitidis serogroups Y, 1 month after vaccination as measured at GSK.||0.99|0.78|
72590410|NCT01869699|144712897|SUPERIORITY||Mean Difference (Final Values)|-0.47||||0.002|TWO_SIDED|95.0|-0.76|-0.18|||ANCOVA|||We estimated that 20 patients per group would provide 80% power for detecting a difference in means of 0.6 degrees Celsius, with a pooled SD of 0.67 degrees, using a two group t test and a two sided alpha level of 0.05. A previous RCT of IV acetaminophen in healthy male volunteers with induced fever found a core temperature difference of 0.60 degrees with a common SD of 0.67 degrees Celsius.||-0.18|-0.76|0.002
72590411|NCT01869699|144712898|SUPERIORITY||Mean Difference (Final Values)|-6.0||||0.03|TWO_SIDED|95.0|-10.0|-1.0|||ANCOVA|||||-1|-10|0.03
72590412|NCT01869699|144712899|SUPERIORITY||Mean Difference (Final Values)|-17.0|||<|0.001|TWO_SIDED|95.0|-25.0|-8.0|||ANCOVA|||||-8|-25|<0.001
72590413|NCT01869699|144712900|SUPERIORITY||Mean Difference (Final Values)|-1.0||||0.42|TWO_SIDED|95.0|-4.0|12.0|||ANCOVA|||||12|-4|0.42
72590414|NCT01869699|144712901|SUPERIORITY||Mean Difference (Final Values)|-0.6||||0.002|TWO_SIDED|95.0|-1.0|-0.3|||ANCOVA|||||-0.3|-1|0.002
72590415|NCT01869699|144712902|SUPERIORITY||Mean Difference (Final Values)|-24.0||||0.001|TWO_SIDED|95.0|-38.0|-10.0|||ANCOVA|||||-10|-38|0.001
72590416|NCT01869699|144712903|SUPERIORITY||Mean Difference (Final Values)|-8.0||||0.02|TWO_SIDED|95.0|-15.0|-1.0|||ANCOVA|||||-1|-15|0.02
72590417|NCT02447497|144712926|SUPERIORITY||Mean Difference (Final Values)|1.97|STANDARD_ERROR_OF_MEAN|0.24|<|0.0001|TWO_SIDED|95.0|0.51|4.1|||Paired t-test|||48 hours post treatment time point. The primary analysis used a modified intent to treat population. Subjects were excluded who did not meet the treatment day baseline requirement of greater than or equal to 3.0 log10 CFU/cm\^2 on the abdomen. The null hypothesis is that there is no difference in log10 CFU/cm\^2 recovery between arms.||4.10|0.51|<0.0001
72414244|NCT03394924|144337655|SUPERIORITY||Least squares mean difference|-0.4||||0.11|TWO_SIDED|95.0|-0.9|0.09|||ANCOVA|||Analysis for TNF α.||0.09|-0.9|0.11
72590418|NCT02447497|144712926|SUPERIORITY||Mean Difference (Final Values)|2.37|STANDARD_ERROR_OF_MEAN|0.29||0.0001|TWO_SIDED|95.0|0.6|5.75|||Paired t-test|||48 hours post treatment. The primary analysis used a modified intent to treat population. Subjects were excluded who did not meet the treatment day baseline requirement of greater than or equal to 3.0 log10 CFU/cm\^2 on the groin. The null hypothesis is that there is no difference in log10 CFU/cm\^2 recovery between arms.||5.75|0.60|0.0001
72590419|NCT02447497|144712926|SUPERIORITY||Mean Difference (Final Values)|1.51|STANDARD_ERROR_OF_MEAN|0.23||0.0001|TWO_SIDED|95.0|0.17|3.75|||Paired t-test|||72 hours post treatment. The primary analysis used a modified intent to treat population. Subjects were excluded who did not meet the treatment day baseline requirement of greater than or equal to 3.0 log10 CFUcm2 on the groin. The null hypothesis is that there is no difference in log10 CFU/cm\^2 recovery between arms.||3.75|0.17|0.0001
72590420|NCT02447497|144712926|SUPERIORITY||Mean Difference (Final Values)|2.4|STANDARD_ERROR_OF_MEAN|0.33||0.0001|TWO_SIDED|95.0|0.13|5.04|||Paired t-test|||72 hours post treatment. The primary analysis used a modified intent to treat population. Subjects were excluded who did not meet the treatment day baseline requirement of greater than or equal to 3.0 log10 CFUcm2 on the groin. The null hypothesis is that there is no difference in log10 CFU/cm\^2 recovery between arms.||5.04|0.13|0.0001
72590421|NCT02017912|144712930|SUPERIORITY||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.5567||0.7208|TWO_SIDED|95.0|-1.321|0.92|||Mixed Models Analysis|||||0.920|-1.321|0.7208
72590422|NCT02017912|144712931|SUPERIORITY||Mean Difference (Final Values)|-0.41|STANDARD_ERROR_OF_MEAN|0.881||0.641|TWO_SIDED|95.0|-2.187|1.36|||Mixed Models Analysis|||||1.360|-2.187|0.6410
72590423|NCT01322035|144712932|EQUIVALENCE|95% confidence limits from standard deviation of the mean were used as the equivalence.|||||<|0.05|||||||Wilcoxon (Mann-Whitney)|95% confidence limits from standard deviation||||||<0.05
72590424|NCT00732758|144712936|SUPERIORITY_OR_OTHER|||||||0.003|TWO_SIDED||||||ANCOVA|adjusting for baseline 25(OH)D, race, BMI, diet vitamin D, gender, pubertal status, and sunlight exposure.||||||0.003
72590425|NCT00732758|144712937|SUPERIORITY_OR_OTHER|||||||0.51|TWO_SIDED||||||t-test, 2 sided|unadjusted p-values||||||0.51
72590426|NCT00732758|144712938|SUPERIORITY_OR_OTHER|||||||0.66|TWO_SIDED||||||t-test, 2 sided|||||||0.66
72590427|NCT00732758|144712939|SUPERIORITY_OR_OTHER|||||||0.35|TWO_SIDED||||||t-test, 2 sided|||||||0.35
72590428|NCT01508130|144712952|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.08||||0.6451|TWO_SIDED|95.0|0.78|1.49|||Wald residual chi-square test||Due to the non-interventional study design, the Cox model included a propensity score as a covariate (incorporated important demographics and baseline characteristics) to account for the potential imbalance between treatment groups.|||1.49|0.78|0.6451
72414245|NCT03394924|144337656|SUPERIORITY||Least squares mean difference|0.01||||0.944|TWO_SIDED|95.0|-0.25|0.27|||ANCOVA|||Analysis for haptoglobin.||0.27|-0.25|0.944
72414246|NCT03394924|144337656|SUPERIORITY||Least squares mean difference|-0.03||||0.83|TWO_SIDED|95.0|-0.3|0.24|||ANCOVA|||Analysis for haptoglobin.||0.24|-0.3|0.83
72590429|NCT01508130|144712952|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.02||||0.8826|TWO_SIDED|95.0|0.78|1.34|||Wald residual chi-square test||Without Propensity Score as a Covariate.|||1.34|0.78|0.8826
72590430|NCT01508130|144712953|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.93||||0.7695|TWO_SIDED|95.0|0.58|1.49|||Multiple Logistic Regression||A multiple logistic regression model including a propensity score as a covariate (incorporated important demographics and baseline characteristics) was used for the treatment comparison.|||1.49|0.58|0.7695
72590431|NCT01508130|144712953|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.27||||0.2594|TWO_SIDED|95.0|0.84|1.92|||Multiple Logistic Regression||Without Propensity Score as a Covariate|||1.92|0.84|0.2594
72590432|NCT01508130|144712960|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.03||||0.9156|TWO_SIDED|95.0|0.64|1.64|||Wald residual chi-square test||95% CI for median was computed using the method of Brookmeyer and Crowley.|||1.64|0.64|0.9156
72590433|NCT01508130|144712961|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.88||||0.5649|TWO_SIDED|95.0|0.57|1.36|||Wald residual chi-square test||95% CI for median was computed using the method of Brookmeyer and Crowley.|||1.36|0.57|0.5649
72590434|NCT01252563|144712984|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||Week 4|t-test, 1 sided|A one-sided paired t-test was performed to test the hypothesis.||The null hypothesis was that the mean change in ambulatory SBP from the baseline was equal to 0.||||<0.001
72590435|NCT01252563|144712984|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||Week 8|t-test, 1 sided|A one-sided paired t-test was performed to test the hypothesis.||The null hypothesis was that the mean change in ambulatory SBP from the baseline was equal to 0.||||<0.001
72590436|NCT01252563|144712984|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||Week 12|t-test, 1 sided|A one-sided paired t-test was performed to test the hypothesis.||The null hypothesis was that the mean change in ambulatory SBP from the baseline was equal to 0.||||<0.001
72414247|NCT03394924|144337656|SUPERIORITY||Least squares mean difference|-0.04||||0.546|TWO_SIDED|95.0|-0.19|0.1|||ANCOVA|||Analysis for alpha2 macroglobulin.||0.1|-0.19|0.546
72414248|NCT03394924|144337656|SUPERIORITY||Least squares mean difference|-0.02||||0.785|TWO_SIDED|95.0|-0.18|0.13|||ANCOVA|||Analysis for alpha2 macroglobulin.||0.13|-0.18|0.785
72590437|NCT01252563|144712984|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||Last Day|t-test, 1 sided|A one-sided paired t-test was performed to test the hypothesis.||The null hypothesis was that the mean change in ambulatory SBP from the baseline was equal to 0.||||<0.001
72590438|NCT01252563|144712985|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||Week 4|t-test, 1 sided|A one-sided paired t-test was performed to test the hypothesis.||The null hypothesis was that the mean change in ambulatory DBP from the baseline was equal to 0.||||<0.001
72590439|NCT01252563|144712985|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||Week 8|t-test, 1 sided|A one-sided paired t-test was performed to test the hypothesis.||The null hypothesis was that the mean change in ambulatory DBP from the baseline was equal to 0.||||<0.001
72414249|NCT03394924|144337657|SUPERIORITY||Least squares mean difference|-0.17||||0.176|TWO_SIDED|95.0|-0.43|0.08|||ANCOVA|||Analysis for TG.||0.08|-0.43|0.176
72590440|NCT01252563|144712985|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||Week 12|t-test, 1 sided|A one-sided paired t-test was performed to test the hypothesis.||The null hypothesis was that the mean change in ambulatory DBP from the baseline was equal to 0.||||<0.001
72590441|NCT01252563|144712985|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||Last Day|t-test, 1 sided|A one-sided paired t-test was performed to test the hypothesis.||The null hypothesis was that the mean change in ambulatory DBP from the baseline was equal to 0.||||<0.001
72590442|NCT01252563|144712988|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Chi-squared|||"The risk factor tested was Complication. The null hypothesis was that there was no difference between participants with complication(s) and participants without complication in the frequency of treatment-related adverse events."||||<0.001
72414250|NCT03394924|144337657|SUPERIORITY||Least squares mean difference|-0.04||||0.783|TWO_SIDED|95.0|-0.3|0.23|||ANCOVA|||Analysis for TG.||0.23|-0.3|0.783
72590443|NCT01252563|144712989|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Chi-squared|||"The risk factor tested was Gender. The null hypothesis was that there was no difference between male and female in the frequency of treatment-related adverse events."||||<0.001
72414251|NCT03394924|144337657|SUPERIORITY||Least squares mean difference|-0.64||||0.061|TWO_SIDED|95.0|-1.31|0.03|||ANCOVA|||Analysis for TC.||0.03|-1.31|0.061
72414252|NCT03394924|144337657|SUPERIORITY||Least squares mean difference|-0.63||||0.08|TWO_SIDED|95.0|-1.34|0.08|||ANCOVA|||Analysis for TC.||0.08|-1.34|0.08
72414253|NCT03394924|144337657|SUPERIORITY||Least squares mean difference|0.08||||0.584|TWO_SIDED|95.0|-0.21|0.37|||ANCOVA|||Analysis for HDL-C.||0.37|-0.21|0.584
72414254|NCT03394924|144337657|SUPERIORITY||Least squares mean difference|-0.22||||0.148|TWO_SIDED|95.0|-0.51|0.08|||ANCOVA|||Analysis for HDL-C.||0.08|-0.51|0.148
72414255|NCT03394924|144337657|SUPERIORITY||Least squares mean difference|-0.5||||0.074|TWO_SIDED|95.0|-1.04|0.05|||ANCOVA|||Analysis for LDL-C.||0.05|-1.04|0.074
72590444|NCT01252563|144712990|SUPERIORITY_OR_OTHER_LEGACY|||||||0.036|||||||Chi-squared|||"The risk factor tested was angina pectoris as a complication. The null hypothesis was that there was no difference between participants with angina pectoris and participants without angina pectoris in the frequency of treatment-related adverse events."||||0.036
72590445|NCT01252563|144712991|SUPERIORITY_OR_OTHER_LEGACY|||||||0.02|||||||Chi-squared|||"The risk factor tested was dyslipidaemia as a complication. The null hypothesis was that there was no difference between participants with dyslipidaemia and participants without dyslipidaemia in the frequency of treatment-related adverse events."||||0.020
72590446|NCT01252563|144712992|SUPERIORITY_OR_OTHER_LEGACY|||||||0.049|||||||Chi-squared|||"The risk factor tested was antihypertensive as a concomitant drug. The null hypothesis was that there was no difference between participants receiving antihypertensive and participants receiving no antihypertensive in the frequency of treatment-related adverse events."||||0.049
72590447|NCT01252563|144712993|SUPERIORITY_OR_OTHER_LEGACY|||||||0.043|||||||Chi-squared|||"The risk factor tested was ARB as a concomitant drug. The null hypothesis was that there was no difference between participants receiving ARB and participants receiving no ARB in the frequency of treatment-related adverse events."||||0.043
72414256|NCT03394924|144337657|SUPERIORITY||Least squares mean difference|-0.3||||0.304|TWO_SIDED|95.0|-0.87|0.28|||ANCOVA|||Analysis for LDL-C.||0.28|-0.87|0.304
72590448|NCT01252563|144712994|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Chi-squared|||"The risk factor tested was diabetes mellitus as a complication. The null hypothesis was that there was no difference between participants with diabetes mellitus and participants without diabetes mellitus in the efficacy."||||<0.001
72590449|NCT01252563|144712995|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Chi-squared|||"The risk factor tested was chronic kidney disease as a complication. The null hypothesis was that there was no difference between participants with chronic kidney disease and participants without chronic kidney disease in the efficacy."||||<0.001
72590450|NCT01252563|144712996|SUPERIORITY_OR_OTHER_LEGACY|||||||0.039|||||||Chi-squared|||"The risk factor tested was myocardial infarction as a complication. The null hypothesis was that there was no difference between participants with myocardial infarction and participants without myocardial infarction in the efficacy."||||0.039
72590451|NCT01252563|144712997|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Chi-squared|||"The risk factor tested was metabolic syndrome as a complication. The null hypothesis was that there was no difference between participants with metabolic syndrome and participants without metabolic syndrome in the efficacy."||||<0.001
72590452|NCT01252563|144712998|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Chi-squared|||"The risk factor tested was ambulatory SBP at baseline. The null hypothesis was that there was no association between ambulatory SBP at baseline and the number of participants who achieved the target blood pressure specified in the guidelines."||||<0.001
72590453|NCT01252563|144713000|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||Week 4|t-test, 1 sided|A one-sided paired t-test was performed to test the hypothesis.||The null hypothesis was that the mean change in home SBP from the baseline was equal to 0.||||<0.001
72590454|NCT01252563|144713000|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||Week 8|t-test, 1 sided|A one-sided paired t-test was performed to test the hypothesis.||The null hypothesis was that the mean change in home SBP from the baseline was equal to 0.||||<0.001
72590455|NCT01252563|144713000|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||Week 12|t-test, 1 sided|A one-sided paired t-test was performed to test the hypothesis.||The null hypothesis was that the mean change in home SBP from the baseline was equal to 0.||||<0.001
72590456|NCT01252563|144713000|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||Last Day|t-test, 1 sided|A one-sided paired t-test was performed to test the hypothesis.||The null hypothesis was that the mean change in home SBP from the baseline was equal to 0.||||<0.001
72590457|NCT01252563|144713001|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||Week 4|t-test, 1 sided|A one-sided paired t-test was performed to test the hypothesis.||The null hypothesis was that the mean changes in home DBP from the baseline are equal to 0.||||<0.001
72414257|NCT03394924|144337658|SUPERIORITY||Least squares mean difference|0.25||||0.378|TWO_SIDED|95.0|-0.32|0.82|||ANCOVA|||Analysis for duration.||0.82|-0.32|0.378
72414258|NCT03394924|144337658|SUPERIORITY||Least squares mean difference|0.65||||0.03|TWO_SIDED|95.0|0.07|1.23|||ANCOVA|||Analysis for duration.||1.23|0.07|0.03
72414259|NCT03394924|144337658|SUPERIORITY||Least squares mean difference|0.53||||0.036|TWO_SIDED|95.0|0.04|1.03|||ANCOVA|||Analysis for degree.||1.03|0.04|0.036
72590458|NCT01252563|144713001|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||Week 8|t-test, 1 sided|A one-sided paired t-test was performed to test the hypothesis.||The null hypothesis was that the mean changes in home DBP from the baseline are equal to 0.||||<0.001
72590459|NCT01252563|144713001|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||Week 12|t-test, 1 sided|A one-sided paired t-test was performed to test the hypothesis.||The null hypothesis was that the mean changes in home DBP from the baseline are equal to 0.||||<0.001
72414260|NCT03394924|144337658|SUPERIORITY||Least squares mean difference|1.18||||0|TWO_SIDED|95.0|0.67|1.69|||ANCOVA|||Analysis for degree.||1.69|0.67|0.000
72414261|NCT03394924|144337658|SUPERIORITY||Least squares mean difference|0.02||||0.971|TWO_SIDED|95.0|-0.92|0.96|||ANCOVA|||Analysis for direction.||0.96|-0.92|0.971
72414262|NCT03394924|144337658|SUPERIORITY||Least squares mean difference|1.01||||0.042|TWO_SIDED|95.0|0.04|1.99|||ANCOVA|||Analysis for direction.||1.99|0.04|0.042
72590460|NCT01252563|144713001|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||Last Day|t-test, 1 sided|A one-sided paired t-test was performed to test the hypothesis.||The null hypothesis was that the mean changes in home DBP from the baseline are equal to 0.||||<0.001
72590461|NCT00387010|144713007|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.6||||0.3223|TWO_SIDED|95.0|-4.64|1.54|||t-test, 2 sided|||||1.54|-4.64|0.3223
72590462|NCT00915876|144713048|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||||||>0.05
72590463|NCT02572076|144713050|OTHER|Pilot study- no sample size was calculated|number of subjects with adequate cleansi|100.0|||||TWO_SIDED|95.0|66.0|100.0||||||patients had partial bowel preparation to mimic poor bowel cleansing before the colonoscopy procedure at baseline, MCS was used during the procedure to clean the colon.||100|66|
72590464|NCT02496091|144713051|OTHER||95% confidence interval (using the exact|92.7|||||TWO_SIDED|95.0|88.8|95.5||||||Only descriptive statistics The implant success rate is analyzed on an implant level (i.e. percent of successful implants) as well as subject level (i.e. percentage of subjects with no unsuccessful implants). This proportion is presented together with a 95% confidence interval (using the exact Binomial approach) and an average follow-up time.||95.5|88.8|
72590465|NCT02272842|144713057|SUPERIORITY|The study had 80% power to detect a standardized effect size of 0.22 and had 90% power to detect an effect size of 0.28. In these calculations, we assumed a loss to follow-up of 10%. Details on the samples size calculations are also presented in the previously published protocol paper.|Mean Difference (Final Values)|0.16|STANDARD_ERROR_OF_MEAN|0.35|>|0.16|TWO_SIDED|95.0|-0.54|0.87||The main analysis was the change in cognitive scores from baseline until the end of the intervention.|t-test, 2 sided||This is the P-value for the effect on the cognitive scores.|||.87|-.54|>.16
72590466|NCT02272842|144713067|SUPERIORITY|the means were compared using Students t-test|Mean Difference (Final Values)|-0.5|||>|0.3|TWO_SIDED|95.0|-1.97|0.94||"Mean difference -0.5 points in the Wechsler Preschool and Primary Scale of Intelligence - Fourth Edition.~95 % Confidence Interval of the mean difference: (-1.97, 0.94)"|t-test, 2 sided|||Comparing mean differences between the two study arms||0.94|-1.97|>.3
72590467|NCT03518619|144713083|OTHER|This is a single group design. Paired-samples t-tests were conducted.|||||<|0.05||||||This is a calculated p-value.|t-test, 2 sided|||||||<.05
72590468|NCT03518619|144713084|OTHER|This is a single group design. Paired-samples t-tests were conducted.|||||<|0.01||||||This is a calculated p-value.|t-test, 2 sided|||||||<.01
72590469|NCT01640379|144713089|SUPERIORITY||Odds Ratio (OR)|0.4||||0.07|TWO_SIDED|95.0|0.15|1.09||Judged by type one error limit alpha = 0.05.|t-test, 2 sided||The odds ratio is for the difference in chlamydia or gonorrhea (CT/GC) rates between arms at ninety days after intervention.|A comparison of Chlamydia or Gonorrhea positivity at 90 days post intervention.||1.09|0.15|0.070
72590470|NCT01640379|144713089|SUPERIORITY||Odds Ratio (OR)|0.59||||0.043|TWO_SIDED|95.0|0.39|0.98||Judged by type one error limit alpha = 0.05.|generalized estimating equations||The odds ratio is for the difference in rate of change over time between arms, so is the difference in the odds increment for those receiving TECH N intervention versus the control group.|"We used generalized estimating equations to test for a difference in the trend of chlamydia or gonorrhea (CT/GC) rates over the study period.~The null hypothesis is that rates of CT/GC for women in the intervention arm were changing over the study period similarly to CT/GC rates in the control arm."||0.98|0.39|0.043
72590471|NCT01640379|144713090|SUPERIORITY||Odds Ratio (OR)|92.2|||<|0.001|TWO_SIDED|95.0|37.0|230.1|||Chi-squared|Adjusted for age, debut age, number of lifetime partners, baseline STI status (any vs none), insurance, and if woman had prior pregnancy.|Odds ratio is interpretable as the expected chance of having a 72 follow-up for intervention women compared to women in the control arm, given similar age, debut age, number of lifetime partners, baseline STI status, insurance, and pregnancy history.|H0: Women in TECHN arm had 72 hour visit with same frequency as women in control arm.||230.1|37.0|<0.001
72590472|NCT01640379|144713090|SUPERIORITY||Odds Ratio (OR)|0.6||||0.084|TWO_SIDED|95.0|0.36|1.05|||Regression, Logistic|Adjusted for age, debut age, number of lifetime partners, pregnancy history, baseline STI status (any versus none), and insurance.|Odds ratio is for intervention arm relative to control.|H0: Women in TECHN arm reported complete adherence to medication regimen (yes or no) with same frequency as women in control arm.||1.05|0.36|0.084
72590473|NCT01640379|144713090|SUPERIORITY||Odds Ratio (OR)|0.9||||0.867|TWO_SIDED|95.0|0.36|2.34|||Regression, Logistic|Adjusted for age, debut age, number of lifetime partners, pregnancy history, baseline STI status (any versus none), and insurance.|Odds ratio is for the chances of partner notification among TECH N recipients, relative to those in control arm.|H0: Women in TECHN arm notified their partners about their diagnoses more often than women in the control arm.||2.34|0.36|0.867
72590474|NCT01640379|144713090|SUPERIORITY||Odds Ratio (OR)|0.6||||0.153|TWO_SIDED|95.0|0.33|1.19|||Regression, Logistic|Adjusted for age, debut age, number of lifetime partners, pregnancy history, baseline STI status (any versus none), and insurance.|Odds ratio is for partners of TECH-N recipients versus partners of women in control arm.|H0: Partners of women receiving the TECH-N intervention were treated more often than the partners of women in the control arm.||1.19|0.33|0.153
72590475|NCT01640379|144713090|SUPERIORITY||Odds Ratio (OR)|1.0||||0.351|TWO_SIDED|95.0|0.86|1.06|||Regression, Logistic|Adjusted for age, debut age, number of lifetime partners, pregnancy history, baseline STI status (any versus none), and insurance.|Odds ratio is for women in the TECH-N arm relative to women in the control arm.|H0: Women in the TECHN arm practiced temporary sexual abstinence for two weeks after their diagnosis more often than those in the control arm.||1.06|0.86|0.351
72590476|NCT03395184|144713105|OTHER||Percentage risk difference|14.3||||0.0119|TWO_SIDED|90.0|4.0|24.5|||Min risk weight method(Mehrotra-Railkar)||90% CI was calculated using minimum (min) risk weight method (Mehrotra-Railkar 2000)|||24.5|4.0|0.0119
72590477|NCT03395184|144713105|OTHER||Percentage risk difference|21.4||||0.0012|TWO_SIDED|90.0|10.0|32.9|||Min risk weight method(Mehrotra-Railkar)||90% CI was calculated using minimum risk weight method (Mehrotra-Railkar, 2000).|||32.9|10.0|0.0012
72590478|NCT03395184|144713119|OTHER||Percentage risk difference|13.3||||0.039|TWO_SIDED|90.0|1.0|25.7|||Min risk weight method(Mehrotra-Railkar)||90% CI was calculated using minimum risk weight method (Mehrotra-Railkar, 2000).|||25.7|1.0|0.0390
72590479|NCT03395184|144713119|OTHER||Percentage risk difference|29.7||||0.0001|TWO_SIDED|90.0|17.2|42.2|||Min risk weight method(Mehrotra-Railkar)||90% CI was calculated using minimum risk weight method (Mehrotra-Railkar, 2000).|||42.2|17.2|0.0001
72590480|NCT03395184|144713120|OTHER||LS mean difference|-3.0||||0.0007|TWO_SIDED|90.0|-4.55|-1.48|||ANCOVA|The ANCOVA model included treatment and baseline disease activity/extent as factors, and baseline SES-CD score as a covariate.||||-1.48|-4.55|0.0007
72414263|NCT03394924|144337658|SUPERIORITY||Least squares mean difference|0.37||||0.336|TWO_SIDED|95.0|-0.4|1.14|||ANCOVA|||Analysis for disability.||1.14|-0.4|0.336
72590481|NCT03395184|144713120|OTHER||LS mean difference|-4.9|||<|0.0001|TWO_SIDED|90.0|-6.62|-3.26|||ANCOVA|The ANCOVA model included treatment and baseline disease activity/extent as factors, and baseline SES-CD score as a covariate.||||-3.26|-6.62|<.0001
72590482|NCT03395184|144713121|OTHER||Percentage risk difference|13.9||||0.0279|TWO_SIDED|90.0|2.1|25.6|||Min risk weight method(Mehrotra-Railkar)||90% CI was calculated using using minimum risk weight method (Mehrotra-Railkar, 2000).|||25.6|2.1|0.0279
72590483|NCT03395184|144713121|OTHER||Percentage risk difference|31.5|||<|0.0001|TWO_SIDED|90.0|19.1|43.9|||Min risk weight method(Mehrotra-Railkar)||90% CI was calculated using minimum risk weight method (Mehrotra-Railkar, 2000).|||43.9|19.1|<.0001
72590484|NCT03395184|144713122|OTHER||Percentage risk difference|2.5||||0.2922|TWO_SIDED|90.0|-4.3|9.3|||Min risk weight method(Mehrotra-Railkar)||90% CI was calculated using minimum risk weight method (Mehrotra-Railkar, 2000).|||9.3|-4.3|0.2922
72590485|NCT03395184|144713122|OTHER||Percentage risk difference|7.4||||0.0449|TWO_SIDED|90.0|-0.4|15.2|||Min risk weight method(Mehrotra-Railkar)||90% CI was calculated using minimum risk weight method (Mehrotra-Railkar, 2000).|||15.2|-0.4|0.0449
72590486|NCT03395184|144713123|OTHER||Percentage risk difference|5.8||||0.0998|TWO_SIDED|90.0|-1.6|13.3|||Min risk weight method(Mehrotra-Railkar)||90% CI was calculated using minimum risk weight method (Mehrotra-Railkar, 2000).|||13.3|-1.6|0.0998
72590487|NCT03395184|144713123|OTHER||Percentage risk difference|11.8||||0.0111|TWO_SIDED|90.0|2.8|20.9|||Min risk weight method(Mehrotra-Railkar)||90% CI was calculated using minimum risk weight method (Mehrotra-Railkar, 2000).|||20.9|2.8|0.0111
72414264|NCT03394924|144337658|SUPERIORITY||Least squares mean difference|1.46||||0|TWO_SIDED|95.0|0.67|2.26|||ANCOVA|||Analysis for disability.||2.26|0.67|0.000
72590488|NCT01953874|144713128|OTHER|The primary analysis was based on the Wilcoxon-Mann-Whitney test and therefore the power calculation was approximated using the approach of Tang.||||||0.916|||||||Wilcoxon (Mann-Whitney)|||The primary endpoint was a composite measure of global rank order response based on survival time, freedom from CV hospitalization, and improvement in functional capacity measured by percent change in 6MWD from baseline to 6 months. The plan was to randomize up to 215 subjects. However, due to safety issues observed in SERVE-HF, randomization was stopped at 126 subjects.||||0.916
72590489|NCT03339726|144713148|SUPERIORITY||Mean Difference (Final Values)|0.23|STANDARD_ERROR_OF_MEAN|0.22||0.3|TWO_SIDED|95.0|-0.205|0.662||The significance threshold level was 0.05 (two sided).|ANOVA|Treatment and baseline nasal congestion score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.662|-0.205|0.300
72590490|NCT03339726|144713148|SUPERIORITY||Mean Difference (Final Values)|0.13|STANDARD_ERROR_OF_MEAN|0.222||0.569|TWO_SIDED|95.0|-0.311|0.564||The significance threshold level was 0.05 (two sided).|ANOVA|Treatment and baseline nasal congestion score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.564|-0.311|0.569
72590491|NCT03339726|144713148|SUPERIORITY||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.22||0.645|TWO_SIDED|95.0|-0.537|0.333||The significance threshold level was 0.05 (two sided).|ANOVA|Treatment and baseline nasal congestion score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.333|-0.537|0.645
72590492|NCT03339726|144713149|SUPERIORITY||Mean Difference (Final Values)|0.25|STANDARD_ERROR_OF_MEAN|0.26||0.346|TWO_SIDED|95.0|-0.267|0.759||The significance threshold level was 0.05 (two sided).|ANOVA|Treatment and baseline nasal congestion score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.759|-0.267|0.346
72590493|NCT03339726|144713149|SUPERIORITY||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.263||0.938|TWO_SIDED|95.0|-0.498|0.539||The significance threshold level was 0.05 (two sided).|ANOVA|Treatment and baseline nasal congestion score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.539|-0.498|0.938
72590494|NCT03339726|144713149|SUPERIORITY||Mean Difference (Final Values)|-0.23|STANDARD_ERROR_OF_MEAN|0.261||0.389|TWO_SIDED|95.0|-0.741|0.289||The significance threshold level was 0.05 (two sided).|ANOVA|Treatment and baseline nasal congestion score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.289|-0.741|0.389
72590495|NCT03339726|144713150|SUPERIORITY||Mean Difference (Final Values)|0.12|STANDARD_ERROR_OF_MEAN|0.23||0.607|TWO_SIDED|95.0|-0.33|0.57|||ANOVA|Treatment and baseline nasal congestion score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.57|-0.33|0.607
72590496|NCT03339726|144713150|SUPERIORITY||Mean Difference (Final Values)|0.4|STANDARD_ERROR_OF_MEAN|0.232||0.085|TWO_SIDED|95.0|-0.06|0.86||The significance threshold level was 0.05 (two sided).|ANOVA|Treatment and baseline nasal congestion score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.86|-0.06|0.085
72590497|NCT03339726|144713150|SUPERIORITY||Mean Difference (Final Values)|0.28|STANDARD_ERROR_OF_MEAN|0.23||0.22|TWO_SIDED|95.0|-0.17|0.74||The significance threshold level was 0.05 (two sided).|ANOVA|Treatment and baseline nasal congestion score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.74|-0.17|0.220
72590498|NCT03339726|144713151|SUPERIORITY||Mean Difference (Final Values)|0.13|STANDARD_ERROR_OF_MEAN|0.271||0.633|TWO_SIDED|95.0|-0.4|0.66||The significance threshold level was 0.05 (two sided).|ANOVA|Treatment and baseline nasal congestion score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.66|-0.40|0.633
72590499|NCT03339726|144713151|SUPERIORITY||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.273||0.952|TWO_SIDED|95.0|-0.52|0.56||The significance threshold level was 0.05 (two sided).|ANOVA|Treatment and baseline nasal congestion score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.56|-0.52|0.952
72590500|NCT03339726|144713151|SUPERIORITY||Mean Difference (Final Values)|-0.11|STANDARD_ERROR_OF_MEAN|0.272||0.678|TWO_SIDED|95.0|-0.65|0.42||The significance threshold level was 0.05 (two sided).|ANOVA|Treatment and baseline nasal congestion score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.42|-0.65|0.678
72414265|NCT03394924|144337658|SUPERIORITY||Least squares mean difference|0.48||||0.214|TWO_SIDED|95.0|-0.29|1.25|||ANCOVA|||Analysis for distribution.||1.25|-0.29|0.214
72590501|NCT03339726|144713152|SUPERIORITY||Mean Difference (Final Values)|0.38|STANDARD_ERROR_OF_MEAN|0.25||0.126|TWO_SIDED|95.0|-0.11|0.88||The significance threshold level was 0.05 (two sided).|ANOVA|Treatment and baseline nasal congestion score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.88|-0.11|0.126
72590502|NCT03339726|144713152|SUPERIORITY||Mean Difference (Final Values)|0.28|STANDARD_ERROR_OF_MEAN|0.253||0.27|TWO_SIDED|95.0|-0.22|0.78||The significance threshold level was 0.05 (two sided).|ANOVA|Treatment and baseline nasal congestion score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.78|-0.22|0.270
72590503|NCT03339726|144713152|SUPERIORITY||Mean Difference (Final Values)|-0.11|STANDARD_ERROR_OF_MEAN|0.251||0.676|TWO_SIDED|95.0|-0.6|0.39||The significance threshold level was 0.05 (two sided).|ANOVA|Treatment and baseline nasal congestion score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.39|-0.60|0.676
72414266|NCT03394924|144337658|SUPERIORITY||Least squares mean difference|1.23||||0.003|TWO_SIDED|95.0|0.44|2.02|||ANCOVA|||Analysis for distribution.||2.02|0.44|0.003
72414267|NCT03394924|144337658|SUPERIORITY||Least squares mean difference|2.21||||0.103|TWO_SIDED|95.0|-0.47|4.9|||ANCOVA|||Analysis for total.||4.9|-0.47|0.103
72590504|NCT03339726|144713153|SUPERIORITY||Mean Difference (Final Values)|0.21|STANDARD_ERROR_OF_MEAN|0.264||0.421|TWO_SIDED|95.0|-0.31|0.73||The significance threshold level was 0.05 (two sided).|ANOVA|Treatment and baseline nasal congestion score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.73|-0.31|0.421
72590505|NCT03339726|144713153|SUPERIORITY||Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.266||0.97|TWO_SIDED|95.0|-0.54|0.52||The significance threshold level was 0.05 (two sided).|ANOVA|Treatment and baseline nasal congestion score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.52|-0.54|0.970
72590506|NCT03339726|144713153|SUPERIORITY||Mean Difference (Final Values)|-0.22|STANDARD_ERROR_OF_MEAN|0.265||0.401|TWO_SIDED|95.0|-0.74|0.3||The significance threshold level was 0.05 (two sided).|ANOVA|Treatment and baseline nasal congestion score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.30|-0.74|0.401
72590507|NCT03339726|144713154|SUPERIORITY||Mean Difference (Final Values)|0.31|STANDARD_ERROR_OF_MEAN|0.272||0.257|TWO_SIDED|95.0|-0.23|0.85||The significance threshold level was 0.05 (two sided).|ANOVA|Treatment and baseline nasal congestion score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.85|-0.23|0.257
72590508|NCT03339726|144713154|SUPERIORITY||Mean Difference (Final Values)|0.04|STANDARD_ERROR_OF_MEAN|0.275||0.877|TWO_SIDED|95.0|-0.5|0.58||The significance threshold level was 0.05 (two sided).|ANOVA|Treatment and baseline nasal congestion score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.58|-0.50|0.877
72590509|NCT03339726|144713154|SUPERIORITY||Mean Difference (Final Values)|-0.27|STANDARD_ERROR_OF_MEAN|0.273||0.329|TWO_SIDED|95.0|-0.8|0.27||The significance threshold level was 0.05 (two sided).|ANOVA|Treatment and baseline nasal congestion score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.27|-0.80|0.329
72590510|NCT03339726|144713155|SUPERIORITY||Mean Difference (Final Values)|0.22|STANDARD_ERROR_OF_MEAN|0.298||0.469|TWO_SIDED|95.0|-0.37|0.8||The significance threshold level was 0.05 (two sided).|ANOVA|Treatment and baseline nasal congestion score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.80|-0.37|0.469
72590511|NCT03339726|144713155|SUPERIORITY||Mean Difference (Final Values)|0.03|STANDARD_ERROR_OF_MEAN|0.301||0.924|TWO_SIDED|95.0|-0.57|0.62||The significance threshold level was 0.05 (two sided).|ANOVA|Treatment and baseline nasal congestion score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.62|-0.57|0.924
72590512|NCT03339726|144713155|SUPERIORITY||Mean Difference (Final Values)|-0.19|STANDARD_ERROR_OF_MEAN|0.299||0.532|TWO_SIDED|95.0|-0.78|0.4||The significance threshold level was 0.05 (two sided).|ANOVA|Treatment and baseline nasal congestion score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.40|-0.78|0.532
72590513|NCT03339726|144713156|SUPERIORITY||Mean Difference (Final Values)|-0.17|STANDARD_ERROR_OF_MEAN|0.309||0.579|TWO_SIDED|95.0|-0.78|0.44||The significance threshold level was 0.05 (two sided).|ANOVA|Treatment and baseline nasal congestion score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.44|-0.78|0.579
72590514|NCT03339726|144713156|SUPERIORITY||Mean Difference (Final Values)|-0.27|STANDARD_ERROR_OF_MEAN|0.312||0.394|TWO_SIDED|95.0|-0.88|0.35||The significance threshold level was 0.05 (two sided).|ANOVA|Treatment and baseline nasal congestion score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.35|-0.88|0.394
72414268|NCT03394924|144337658|SUPERIORITY||Least squares mean difference|6.35||||0|TWO_SIDED|95.0|3.57|9.13|||ANCOVA|||Analysis for total.||9.13|3.57|0.000
72414269|NCT03394924|144337659|SUPERIORITY||Least squares mean difference|12.48||||0.16|TWO_SIDED|95.0|-5.09|30.06|||ANCOVA|||||30.06|-5.09|0.16
72414270|NCT03394924|144337659|SUPERIORITY||Least squares mean difference|25.58||||0.006|TWO_SIDED|95.0|7.67|43.48|||ANCOVA|||||43.48|7.67|0.006
72414271|NCT03394924|144337660|SUPERIORITY||Least squares mean difference|-0.15||||0.908|TWO_SIDED|95.0|-2.72|2.43|||ANCOVA|||Analysis for symptoms.||2.43|-2.72|0.908
72414272|NCT03394924|144337660|SUPERIORITY||Least squares mean difference|-1.41||||0.298|TWO_SIDED|95.0|-4.09|1.27|||ANCOVA|||Analysis for symptoms.||1.27|-4.09|0.298
72414273|NCT03394924|144337660|SUPERIORITY||Least squares mean difference|1.91||||0.042|TWO_SIDED|95.0|0.07|3.76|||ANCOVA|||Analysis for itch.||3.76|0.07|0.042
72590515|NCT03339726|144713156|SUPERIORITY||Mean Difference (Final Values)|-0.09|STANDARD_ERROR_OF_MEAN|0.31||0.76|TWO_SIDED|95.0|-0.71|0.52||The significance threshold level was 0.05 (two sided).|ANOVA|Treatment and baseline nasal congestion score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.52|-0.71|0.760
72590516|NCT03339726|144713157|SUPERIORITY||Mean Difference (Final Values)|0.11|STANDARD_ERROR_OF_MEAN|0.218||0.616|TWO_SIDED|95.0|-0.32|0.539||The significance threshold level was 0.05 (two sided).|ANCOVA|Treatment and baseline sinus pressure/tenderness score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.539|-0.320|0.616
72590517|NCT03339726|144713157|SUPERIORITY||Mean Difference (Final Values)|0.07|STANDARD_ERROR_OF_MEAN|0.22||0.734|TWO_SIDED|95.0|-0.359|0.508||The significance threshold level was 0.05 (two sided).|ANCOVA|Treatment and baseline sinus pressure/tenderness score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.508|-0.359|0.734
72590518|NCT03339726|144713157|SUPERIORITY||Mean Difference (Final Values)|-0.03|STANDARD_ERROR_OF_MEAN|0.218||0.874|TWO_SIDED|95.0|-0.465|0.395||The significance threshold level was 0.05 (two sided).|ANCOVA|Treatment and baseline sinus pressure/tenderness score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.395|-0.465|0.874
72590519|NCT03339726|144713158|SUPERIORITY||Mean Difference (Final Values)|-0.07|STANDARD_ERROR_OF_MEAN|0.23||0.75|TWO_SIDED|95.0|-0.53|0.38||The significance threshold level was 0.05 (two sided).|ANCOVA|Treatment and baseline sinus pressure/tenderness score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.38|-0.53|0.750
72590520|NCT03339726|144713158|SUPERIORITY||Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|0.232||0.39|TWO_SIDED|95.0|-0.26|0.66||The significance threshold level was 0.05 (two sided).|ANCOVA|Treatment and baseline sinus pressure/tenderness score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.66|-0.26|0.390
72590521|NCT03339726|144713158|SUPERIORITY||Mean Difference (Final Values)|0.27|STANDARD_ERROR_OF_MEAN|0.23||0.236|TWO_SIDED|95.0|-0.18|0.73||The significance threshold level was 0.05 (two sided).|ANCOVA|Treatment and baseline sinus pressure/tenderness score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.73|-0.18|0.236
72590522|NCT03339726|144713159|SUPERIORITY||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.267||0.707|TWO_SIDED|95.0|-0.63|0.43||The significance threshold level was 0.05 (two sided).|ANCOVA|Treatment and baseline sinus pressure/tenderness score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.43|-0.63|0.707
72590523|NCT03339726|144713159|SUPERIORITY||Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.269||0.839|TWO_SIDED|95.0|-0.59|0.48||The significance threshold level was 0.05 (two sided).|ANCOVA|Treatment and baseline sinus pressure/tenderness score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.48|-0.59|0.839
72590524|NCT03339726|144713159|SUPERIORITY||Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.267||0.864|TWO_SIDED|95.0|-0.48|0.57||The significance threshold level was 0.05 (two sided).|ANCOVA|Treatment and baseline sinus pressure/tenderness score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.57|-0.48|0.864
72590525|NCT03339726|144713160|SUPERIORITY||Mean Difference (Final Values)|0.07|STANDARD_ERROR_OF_MEAN|0.255||0.794|TWO_SIDED|95.0|-0.44|0.57||The significance threshold level was 0.05 (two sided).|ANCOVA|Treatment and baseline sinus pressure/tenderness score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.57|-0.44|0.794
72590526|NCT03339726|144713160|SUPERIORITY||Mean Difference (Final Values)|0.12|STANDARD_ERROR_OF_MEAN|0.257||0.628|TWO_SIDED|95.0|-0.38|0.63||The significance threshold level was 0.05 (two sided).|ANCOVA|Treatment and baseline sinus pressure/tenderness score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.63|-0.38|0.628
72590527|NCT03339726|144713160|SUPERIORITY||Mean Difference (Final Values)|0.06|STANDARD_ERROR_OF_MEAN|0.255||0.82|TWO_SIDED|95.0|-0.45|0.56||The significance threshold level was 0.05 (two sided).|ANCOVA|Treatment and baseline sinus pressure/tenderness score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.56|-0.45|0.820
72590528|NCT03339726|144713161|SUPERIORITY||Mean Difference (Final Values)|0.26|STANDARD_ERROR_OF_MEAN|0.266||0.33|TWO_SIDED|95.0|-0.27|0.79||The significance threshold level was 0.05 (two sided).|ANCOVA|Treatment and baseline sinus pressure/tenderness score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.79|-0.27|0.330
72590529|NCT03339726|144713161|SUPERIORITY||Mean Difference (Final Values)|0.13|STANDARD_ERROR_OF_MEAN|0.269||0.631|TWO_SIDED|95.0|-0.4|0.66||The significance threshold level was 0.05 (two sided).|ANCOVA|Treatment and baseline sinus pressure/tenderness score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.66|-0.40|0.631
72590530|NCT03339726|144713161|SUPERIORITY||Mean Difference (Final Values)|-0.13|STANDARD_ERROR_OF_MEAN|0.266||0.625|TWO_SIDED|95.0|-0.66|0.4||The significance threshold level was 0.05 (two sided).|ANCOVA|Treatment and baseline sinus pressure/tenderness score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.40|-0.66|0.625
72590531|NCT03339726|144713162|SUPERIORITY||Mean Difference (Final Values)|0.32|STANDARD_ERROR_OF_MEAN|0.275||0.24|TWO_SIDED|95.0|-0.22|0.87||The significance threshold level was 0.05 (two sided).|ANCOVA|Treatment and baseline sinus pressure/tenderness score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.87|-0.22|0.240
72590532|NCT03339726|144713162|SUPERIORITY||Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.278||0.865|TWO_SIDED|95.0|-0.5|0.6||The significance threshold level was 0.05 (two sided).|ANCOVA|Treatment and baseline sinus pressure/tenderness score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.60|-0.50|0.865
72590533|NCT03339726|144713162|SUPERIORITY||Mean Difference (Final Values)|-0.28|STANDARD_ERROR_OF_MEAN|0.275||0.316|TWO_SIDED|95.0|-0.82|0.27||The significance threshold level was 0.05 (two sided).|ANCOVA|Treatment and baseline sinus pressure/tenderness score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.27|-0.82|0.316
72590534|NCT03339726|144713163|SUPERIORITY||Mean Difference (Final Values)|0.18|STANDARD_ERROR_OF_MEAN|0.284||0.529|TWO_SIDED|95.0|-0.38|0.74||The significance threshold level was 0.05 (two sided).|ANCOVA|Treatment and baseline sinus pressure/tenderness score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.74|-0.38|0.529
72590535|NCT03339726|144713163|SUPERIORITY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.287||0.997|TWO_SIDED|95.0|-0.56|0.57||The significance threshold level was 0.05 (two sided).|ANCOVA|Treatment and baseline sinus pressure/tenderness score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.57|-0.56|0.997
72414274|NCT03394924|144337660|SUPERIORITY||Least squares mean difference|3.47||||0.001|TWO_SIDED|95.0|1.55|5.38|||ANCOVA|||Analysis for itch.||5.38|1.55|0.001
72590536|NCT03339726|144713163|SUPERIORITY||Mean Difference (Final Values)|-0.18|STANDARD_ERROR_OF_MEAN|0.285||0.532|TWO_SIDED|95.0|-0.74|0.38||The significance threshold level was 0.05 (two sided).|ANCOVA|Treatment and baseline sinus pressure/tenderness score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.38|-0.74|0.532
72414275|NCT03394924|144337660|SUPERIORITY||Least squares mean difference|-0.46||||0.839|TWO_SIDED|95.0|-4.96|4.04|||ANCOVA|||Analysis for fatigue.||4.04|-4.96|0.839
72590537|NCT03339726|144713164|SUPERIORITY||Mean Difference (Final Values)|-0.22|STANDARD_ERROR_OF_MEAN|0.309||0.468|TWO_SIDED|95.0|-0.83|0.38||The significance threshold level was 0.05 (two sided).|ANCOVA|Treatment and baseline sinus pressure/tenderness score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.38|-0.83|0.468
72590538|NCT03339726|144713164|SUPERIORITY||Mean Difference (Final Values)|-0.39|STANDARD_ERROR_OF_MEAN|0.312||0.218|TWO_SIDED|95.0|-1.0|0.23||The significance threshold level was 0.05 (two sided).|ANCOVA|Treatment and baseline sinus pressure/tenderness score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.23|-1.00|0.218
72590539|NCT03339726|144713164|SUPERIORITY||Mean Difference (Final Values)|-0.16|STANDARD_ERROR_OF_MEAN|0.309||0.604|TWO_SIDED|95.0|-0.77|0.45||The significance threshold level was 0.05 (two sided).|ANCOVA|Treatment and baseline sinus pressure/tenderness score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.45|-0.77|0.604
72590540|NCT01246349|144713175|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.616|STANDARD_ERROR_OF_MEAN|7.373||0.24|TWO_SIDED|95.0|-5.871|23.103|||Regression, Linear|||Published results comprise baseline and follow-up means and standard deviations for both the MI and control group (reported above), as well as the absolute attributable effect of intervention (i.e., the difference in self-efficacy \[WEL\] change between the treatment and control groups from baseline to a 6 month follow-up).||23.103|-5.871|0.24
72414276|NCT03394924|144337660|SUPERIORITY||Least squares mean difference|-0.32||||0.891|TWO_SIDED|95.0|-5.0|4.36|||ANCOVA|||Analysis for fatigue.||4.36|-5.00|0.891
72414277|NCT03394924|144337660|SUPERIORITY||Least squares mean difference|0.26||||0.834|TWO_SIDED|95.0|-2.25|2.77|||ANCOVA|||Analysis for cognition.||2.77|-2.25|0.834
72414278|NCT03394924|144337660|SUPERIORITY||Least squares mean difference|1.3||||0.327|TWO_SIDED|95.0|-1.33|3.92|||ANCOVA|||Analysis for cognition.||3.92|-1.33|0.327
72414279|NCT03394924|144337660|SUPERIORITY||Least squares mean difference|-2.12||||0.262|TWO_SIDED|95.0|-5.86|1.62|||ANCOVA|||Analysis for social.||1.62|-5.86|0.262
72414280|NCT03394924|144337660|SUPERIORITY||Least squares mean difference|-0.78||||0.69|TWO_SIDED|95.0|-4.68|3.12|||ANCOVA|||Analysis for social.||3.12|-4.68|0.69
72590541|NCT01246349|144713176|SUPERIORITY_OR_OTHER|||||||0.56|||||||Regression, Linear|||Results published comprise baseline and follow-up BMI z-score means and standard deviations for both the MI and control groups (reported above), as well as the attributable effect of intervention (i.e., the difference in BMI change between the treatment and control groups from baseline to a 6-month follow-up)||||0.56
72590542|NCT01246349|144713177|SUPERIORITY_OR_OTHER|||||||0.09|||||||Regression, Linear|||Results published comprise baseline and follow-up means and standard deviations for both the MI and control group (reported above), as well as the attributable effect of intervention (i.e., the difference in waist circumference change between the treatment and control groups from baseline to a 6-month follow-up).||||0.09
72590543|NCT01246349|144713179|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.183|STANDARD_ERROR_OF_MEAN|1.265||0.88|TWO_SIDED|95.0|-2.301|2.668|||Regression, Linear|||"Based on previous research , baseline CDSS means were expected between 5 - 6.5 with a SD of 3 - 4. It was hypothesized that an attributable effect of 1.5 would be detected.~Published results comprise baseline and follow-up means and standard deviations for both the MI and control group (reported above), as well as the absolute attributable effect of intervention (i.e., the difference in self-efficacy \[CDSS\] change between the treatment and control groups from baseline to a 6 month follow-up)."||2.668|-2.301|0.88
72590544|NCT04934189|144713183|OTHER||Mean Difference (Final Values)|0.295|STANDARD_DEVIATION|1.184||0.08|ONE_SIDED||||||t-test, 1 sided|||A one-tailed paired samples T-test was conducted to determine whether the post-treatment (i.e., 3-month) mean was statistically different from the baseline mean.||||.08
72414281|NCT03394924|144337660|SUPERIORITY||Least squares mean difference|-0.62||||0.433|TWO_SIDED|95.0|-2.19|0.95|||ANCOVA|||Analysis for emotional.||0.95|-2.19|0.433
72590545|NCT04934189|144713184|OTHER||Mean Difference (Net)|0.417|STANDARD_DEVIATION|0.89||0.005|TWO_SIDED||||||t-test, 1 sided|||A one-tailed paired samples T-test was conducted to determine whether the post-treatment (i.e., 6-month follow-up mean) was statistically different from the baseline mean.||||.005
72590546|NCT04934189|144713186|OTHER||Mean Difference (Net)|-0.103|STANDARD_DEVIATION|2.5||0.4|TWO_SIDED||||||t-test, 1 sided|||A one-tailed paired samples T-test was conducted to determine whether the post-treatment (i.e., 3-month) mean was statistically different from the baseline mean.||||0.40
72590547|NCT04934189|144713187|OTHER||Mean Difference (Net)|-0.01|STANDARD_DEVIATION|2.08||0.49|TWO_SIDED||||||t-test, 1 sided|||A one-tailed paired samples T-test was conducted to determine whether the post-treatment (i.e., 6-month follow-up) mean was statistically different from the baseline mean.||||.49
72590548|NCT04934189|144713189|OTHER||Mean Difference (Net)|0.195|STANDARD_DEVIATION|1.41||0.21|TWO_SIDED||||||t-test, 1 sided|||A one-tailed paired samples T-test was conducted to determine whether the post-treatment (i.e., 3-month) mean was statistically different from the baseline mean.||||.21
72414282|NCT03394924|144337660|SUPERIORITY||Least squares mean difference|0.37||||0.653|TWO_SIDED|95.0|-1.28|2.03|||ANCOVA|||Analysis for emotional.||2.03|-1.28|0.653
72414283|NCT03394924|144337664|SUPERIORITY||Least squares mean difference|1.34||||0.971|TWO_SIDED|95.0|-71.51|74.18|||ANCOVA|||Analysis for FGF19.||74.18|-71.51|0.971
72590549|NCT04934189|144713190|OTHER||Mean Difference (Net)|0.019|STANDARD_DEVIATION|1.43||0.47|TWO_SIDED||||||t-test, 1 sided|||A one-tailed paired samples T-test was conducted to determine whether the post-treatment (i.e., 6-month followup) mean was statistically different from the baseline mean.||||.47
72590550|NCT04934189|144713192|OTHER||Mean Difference (Net)|0.175|STANDARD_DEVIATION|1.02||0.16|TWO_SIDED||||||t-test, 1 sided|||A one-tailed paired samples T-test was conducted to determine whether the post-treatment (i.e., 3-month) mean was statistically different from the baseline mean.||||.16
72590551|NCT04934189|144713193|OTHER||Mean Difference (Net)|0.0481|STANDARD_DEVIATION|0.926||0.38|TWO_SIDED||||||t-test, 1 sided|||A one-tailed paired samples T-test was conducted to determine whether the post-treatment (i.e., 6-month followup) mean was statistically different from the baseline mean.||||.38
72590552|NCT04934189|144713195|OTHER||Mean Difference (Net)|0.179|STANDARD_DEVIATION|2.73||0.35|TWO_SIDED||||||t-test, 1 sided|||A one-tailed paired samples T-test was conducted to determine whether the post-treatment (i.e., 3-month) mean was statistically different from the baseline mean.||||.35
72590553|NCT04934189|144713196|OTHER||Mean Difference (Net)|-0.335|STANDARD_DEVIATION|2.05||0.17|TWO_SIDED||||||t-test, 1 sided|||A one-tailed paired samples T-test was conducted to determine whether the post-treatment (i.e., 6-month followup) mean was statistically different from the baseline mean.||||.17
72414284|NCT03394924|144337664|SUPERIORITY||Least squares mean difference|5.54||||0.882|TWO_SIDED|95.0|-68.86|79.95|||ANCOVA|||Analysis for FGF19.||79.95|-68.86|0.882
72590554|NCT04934189|144713200|OTHER|A one-tailed paired samples T-test was conducted to determine whether the post-treatment (i.e., 3-month followup) mean for gender nonaffirmation was statistically different from the baseline mean.|t-test|2.18||||0.02|ONE_SIDED|||||A priori threshold for statistical significance was \<.05|t-test, 1 sided|||||||.02
72414285|NCT03394924|144337664|SUPERIORITY||Least squares mean difference|-51.66||||0.242|TWO_SIDED|95.0|-139.27|35.96|||ANCOVA|||Analysis for C4.||35.96|-139.27|0.242
72414286|NCT03394924|144337664|SUPERIORITY||Least squares mean difference|-94.3||||0.042|TWO_SIDED|95.0|-184.85|-3.75|||ANCOVA|||Analysis for C4.||-3.75|-184.85|0.042
72414287|NCT03394924|144337664|SUPERIORITY||Least squares mean difference|-24.57||||0.52|TWO_SIDED|95.0|-101.03|51.89|||ANCOVA|||Analysis for BA.||51.89|-101.03|0.52
72414288|NCT03394924|144337664|SUPERIORITY||Least squares mean difference|-17.96||||0.672|TWO_SIDED|95.0|-103.07|67.16|||ANCOVA|||Analysis for BA.||67.16|-103.07|0.672
72590555|NCT04934189|144713200|OTHER|A one-tailed paired samples T-test was conducted to determine whether the post-treatment (i.e., 3-month followup) mean for internalized transphobia was statistically different from the baseline mean.|t-test|1.29||||0.1|ONE_SIDED|||||A priori threshold for statistical significant was p \<.05|t-test, 1 sided|||||||.10
72590556|NCT04934189|144713200|OTHER|A one-tailed paired samples T-test was conducted to determine whether the post-treatment (i.e., 3-month followup) mean for identity nondisclosure was statistically different from the baseline mean.|t-test|0.17||||0.43|ONE_SIDED|||||A priori threshold for statistical significance was p \< .05|t-test, 1 sided|||||||.43
72590557|NCT04934189|144713200|OTHER|A one-tailed paired samples T-test was conducted to determine whether the post-treatment (i.e., 3-month followup) mean for negative expectations was statistically different from the baseline mean.|t-test|-0.68||||0.25|ONE_SIDED|||||A priori threshold for statistical significance was p \< .05|t-test, 1 sided|||||||.25
72590558|NCT04934189|144713200|OTHER|A one-tailed paired samples T-test was conducted to determine whether the post-treatment (i.e., 3-month followup) mean for community connection was statistically different from the baseline mean.|t-test|-0.36||||0.36|ONE_SIDED|||||The a priori threshold for statistical significance was p \< .05|t-test, 1 sided|||||||.36
72590559|NCT04934189|144713200|OTHER|A one-tailed paired samples T-test was conducted to determine whether the post-treatment (i.e., 3-month followup) mean for pride was statistically different from the baseline mean.|t-test|-0.09||||0.47|ONE_SIDED|||||The a priori threshold for statistical significance was p \< .05|t-test, 1 sided|||||||.47
72414289|NCT03394924|144337665|SUPERIORITY||Least squares mean difference|44.54||||0.611|TWO_SIDED|95.0|-205.97|295.06|||ANCOVA|||Analysis for FGF19 AUC0-8.||295.06|-205.97|0.611
72414290|NCT03394924|144337665|SUPERIORITY||Least squares mean difference|-29.98||||0.819|TWO_SIDED|95.0|-411.28|351.31|||ANCOVA|||Analysis for FGF19 AUC0-8.||351.31|-411.28|0.819
72414291|NCT03394924|144337665|SUPERIORITY||Least squares mean difference|24.41||||0.818|TWO_SIDED|95.0|-251.92|300.74|||ANCOVA|||Analysis for FGF19 AUC2-8.||300.74|-251.92|0.818
72414292|NCT03394924|144337665|SUPERIORITY||Least squares mean difference|-10.53||||0.948|TWO_SIDED|95.0|-435.33|414.27|||ANCOVA|||Analysis for FGF19 AUC2-8.||414.27|-435.33|0.948
72414293|NCT03394924|144337665|SUPERIORITY||Least squares mean difference|-91.7||||0.412|TWO_SIDED|95.0|-475.92|292.51|||ANCOVA|||Analysis for C4 AUC0-8.||292.51|-475.92|0.412
72414294|NCT03394924|144337665|SUPERIORITY||Least squares mean difference|-250.18||||0.094|TWO_SIDED|95.0|-605.33|104.98|||ANCOVA|||Analysis for C4 AUC0-8.||104.98|-605.33|0.094
72414295|NCT03394924|144337665|SUPERIORITY||Least squares mean difference|-83.7||||0.266|TWO_SIDED|95.0|-279.15|111.75|||ANCOVA|||Analysis for C4 AUC2-8.||111.75|-279.15|0.266
72414296|NCT03394924|144337665|SUPERIORITY||Least squares mean difference|-238.19||||0.047|TWO_SIDED|95.0|-470.22|-6.15|||ANCOVA|||Analysis for C4 AUC2-8.||-6.15|-470.22|0.047
72414297|NCT03394924|144337665|SUPERIORITY||Least squares mean difference|28.41||||0.694|TWO_SIDED|95.0|-180.2|237.02|||ANCOVA|||Analysis for BA AUC0-8.||237.02|-180.2|0.694
72414298|NCT03394924|144337665|SUPERIORITY||Least squares mean difference|-39.5||||0.615|TWO_SIDED|95.0|-264.32|185.32|||ANCOVA|||Analysis for BA AUC0-8.||185.32|-264.32|0.615
72414299|NCT03394924|144337665|SUPERIORITY||Least squares mean difference|2.93||||0.974|TWO_SIDED|95.0|-229.6|235.46|||ANCOVA|||Analysis for BA AUC2-8.||235.46|-229.6|0.974
72414300|NCT03394924|144337665|SUPERIORITY||Least squares mean difference|-26.05||||0.793|TWO_SIDED|95.0|-283.24|231.15|||ANCOVA|||Analysis for BA AUC2-8.||231.15|-283.24|0.793
72414301|NCT03387852|144337676|SUPERIORITY||Odds ratio|0.423|||=|0.0214|TWO_SIDED|95.0|0.203|0.88|||Regression, Logistic||SAR440340 300 mg vs. Placebo|Odds ratio, 95% confidence interval (CI), and p-value derived from logistic regression with treatment, baseline eosinophil strata, region, background ICS dose level at randomization and number of exacerbation events (defined as required use of systemic \[oral and/or parenteral\] steroid treatment, or required hospitalization or emergency room visit) within 1 year prior to screening.||0.88|0.203|=0.0214
72414302|NCT03387852|144337676|SUPERIORITY||Odds ratio|0.52|||=|0.0709|TWO_SIDED|95.0|0.256|1.057|||Regression, Logistic||SAR440340 + Dupilumab vs. Placebo|Odds ratio, 95% CI, and p-value derived from logistic regression with treatment, baseline eosinophil strata, region, background ICS dose level at randomization and number of exacerbation events (defined as required use of systemic \[oral and/or parenteral\] steroid treatment, or required hospitalization or emergency room visit) within 1 year prior to screening.||1.057|0.256|=0.0709
72414303|NCT03069482|144337763|SUPERIORITY||Slope|1.063|STANDARD_DEVIATION|3.377|=|0.754|TWO_SIDED||||||ANOVA|||||||=0.754
72590560|NCT04934189|144713201|OTHER|A one-tailed paired samples T-test was conducted to determine whether the post-treatment (i.e., 6-month followup) mean for gender nonaffirmation was statistically different from the baseline mean.|t-test|3.76|||<|0.001|ONE_SIDED|||||The a priori threshold for statistical significance was p \< .05|t-test, 1 sided||||"A series of one-tailed paired samples T-test was conducted to determine whether the post-treatment (i.e., 6-month followup) mean was statistically different from the baseline mean for each of the five gender minority stress subscales measured. See below for T-scores and associated p-values for each statistical test.~Nonaffirmation (t = 3.76; p = .001) Internalized Transphobia (t = 2.01; p = .02) Negative Expectations (t = 2.06; p =.02) Community Connection (t = -0.82; p =.21) Pride (t = .01; p = .50 )"|||<.001
72590561|NCT04934189|144713201|OTHER|A one-tailed paired samples T-test was conducted to determine whether the post-treatment (i.e., 6-month followup) mean for internalized transphobia was statistically different from the baseline mean.|t-test|2.01||||0.02|ONE_SIDED|||||The a priori threshold for statistical significance is p \< .05|t-test, 1 sided|||||||.02
72590562|NCT04934189|144713201|OTHER|A one-tailed paired samples T-test was conducted to determine whether the post-treatment (i.e., 6-month followup) mean for identity nondisclosure was statistically different from the baseline mean.|t-test|1.61||||0.06|ONE_SIDED|||||The a priori threshold for statistical significance was p \< .05|t-test, 1 sided|||||||.06
72590563|NCT04934189|144713201|OTHER|A one-tailed paired samples T-test was conducted to determine whether the post-treatment (i.e., 6-month followup) mean for negative expectations was statistically different from the baseline mean.|t-test|2.06||||0.02|ONE_SIDED|||||The a priori threshold for statistical significance was p \< .05|t-test, 1 sided|||||||.02
72590564|NCT04934189|144713201|OTHER|A one-tailed paired samples T-test was conducted to determine whether the post-treatment (i.e., 6-month followup) mean for community connection was statistically different from the baseline mean.|t-test|-0.818||||0.21|ONE_SIDED|||||The a priori threshold for statistical significance was p \< .05|t-test, 1 sided|||||||.21
72590565|NCT04934189|144713201|OTHER|A one-tailed paired samples T-test was conducted to determine whether the post-treatment (i.e., 6-month followup) mean for pride was statistically different from the baseline mean.|t-test|0.009||||0.5|ONE_SIDED|||||The a priori threshold for statistical significance was p \< .05|t-test, 1 sided|||||||.50
72590566|NCT04934189|144713204|OTHER||Chi-squared|5.59||||0.04|TWO_SIDED|||||A priori threshold for statistical significance was p \<.05|Chi-squared|||For this categorical data, chi-square tests of independence were performed to compare post-treatment (i.e., 3 month followup) vs 6 month followup numbers of participants reporting freedom from sexual victimization over a 6 month time period||||.04
72414304|NCT03069482|144337764|SUPERIORITY||Risk Ratio (RR)|2.103|STANDARD_DEVIATION|0.369||0.044|TWO_SIDED|95.0|1.2|2.6|||Mixed Models Analysis|Zero inflated negative binomial mixed methods regression.||||2.6|1.2|0.044
72590567|NCT04934189|144713204|OTHER|For this categorical data, chi-square tests of independence were performed to compare post-treatment (i.e., 3 month followup) vs 6 month followup numbers of participants reporting any exposure to nonpenetrative sexual assault over a 6 month time period|Chi-squared|0.21||||0.55|TWO_SIDED|||||A priori threshold for statistical significance was p \< .05|Chi-squared|||||||.55
72414305|NCT03069482|144337765|OTHER||Percent accrual relative to target N|102.0|||||TWO_SIDED||||||||||The goal of this outcome was to determine whether the trial could reach its enrollment target (90 participants).|||
72590568|NCT04934189|144713204|OTHER|For this categorical data, chi-square tests of independence were performed to compare post-treatment (i.e., 3 month followup) vs 6 month followup numbers of participants reporting exposure to rape over a 6 month time period|Chi-squared|0.11||||0.59|TWO_SIDED|||||A priori threshold for statistical significance was p \< .05|Chi-squared|||||||.59
72590569|NCT04934189|144713206|OTHER||Mean Difference (Net)|-0.08|STANDARD_DEVIATION|1.68||0.38|TWO_SIDED||||||t-test, 1 sided|||A one-tailed paired samples T-test was conducted to determine whether the post-treatment (i.e., 3-month) mean was statistically different from the baseline mean.||||.38
72590570|NCT04934189|144713207|OTHER||Mean Difference (Net)|-0.265|STANDARD_DEVIATION|2.21||0.25|ONE_SIDED||||||t-test, 1 sided|||A one-tailed paired samples T-test was conducted to determine whether the post-treatment (i.e., 6-month) mean was statistically different from the baseline mean.||||.25
72590571|NCT03962790|144713208|NON_INFERIORITY|Non-inferiority was declared if the lower bound of the credible interval (CrI) of the mean difference between Test and Control was greater than -5.|Posterior Mean Difference|0.09|STANDARD_DEVIATION|2.281|||TWO_SIDED|95.0|-4.37|4.65|||||Posterior mean difference was calculated as Test - Control|Bayesian repeated measurement random-effects model was used to compare between Test and Control lenses.||4.65|-4.37|
72590572|NCT03962790|144713209|NON_INFERIORITY|Non-inferiority is established if the lower limit of the 95% credible interval is above -5 points in CLUE Scale.|Posterior Mean Difference|-1.02|STANDARD_DEVIATION|1.565|||TWO_SIDED|95.0|-4.07|2.06|||||Posterior mean difference was calculated as Test - Control|Bayesian repeated measurement random-effects model was used to compare between Test and Control lenses.||2.06|-4.07|
72590573|NCT03962790|144713210|NON_INFERIORITY|Non-inferiority was declared if the upper bound of the CrI of the mean difference between Test and Control was less than 0.05.|Posterior Mean Difference|-0.001|STANDARD_DEVIATION|0.0054|||TWO_SIDED|95.0|-0.012|0.01|||||Posterior mean difference was calculated as Test - Control|Bayesian repeated measurement random-effects model was used to compare between Test and Control lenses.||0.010|-0.012|
72590574|NCT03962790|144713210|NON_INFERIORITY|Non-inferiority was declared if the upper bound of the CrI of the mean difference between Test and Control was less than 0.05.|Posterior Mean Difference|-0.002|STANDARD_DEVIATION|0.0057|||TWO_SIDED|95.0|-0.014|0.009|||||Posterior mean difference was calculated as Test - Control|Bayesian repeated measurement random-effects model was used to compare between Test and Control lenses.||0.009|-0.014|
72414306|NCT03069482|144337766|OTHER||Percent retention relative to target|98.3|||||TWO_SIDED||||||||||We calculated the percent of retained participants relative to the retention target (N = 62)|||
72414307|NCT03069482|144337767|OTHER||Percent of respondents|58.0|||||TWO_SIDED|||||||||||||
72590575|NCT03962790|144713211|NON_INFERIORITY|Non-inferiority was declared if the lower bound of the CrI of the mean difference between Test and Control was greater than -1.|Posterior Mean Difference|0.02|STANDARD_DEVIATION|0.168|||TWO_SIDED|95.0|-0.32|0.34|||||Posterior mean difference was calculated as Test - Control|Bayesian repeated measurement random-effects model was used to compare between Test and Control lenses.||0.34|-0.32|
72590576|NCT01286168|144713214|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED||||||McNemar|||Antisepsis and Control sides were compared.||||0.02
72590577|NCT01286168|144713215|SUPERIORITY_OR_OTHER|||||||0.03|TWO_SIDED||||||McNemar|||Antisepsis and Control sides were compared.||||0.03
72414308|NCT03069482|144337769|SUPERIORITY||Trimmed mean difference|8.29574|STANDARD_ERROR_OF_MEAN|2.11||0.046|TWO_SIDED|95.0|0.138|16.453|||Yuen's trimmed mean t-test|||||16.453|0.138|0.046
72590578|NCT01286168|144713216|SUPERIORITY_OR_OTHER|||||||0.003|||||||McNemar|||Antisepsis and Control sides were compared.||||0.003
72590579|NCT01286168|144713217|SUPERIORITY_OR_OTHER|||||||0.13|TWO_SIDED||||||McNemar|||Antisepsis and Control sides were compared.||||0.13
72590580|NCT01286168|144713218|SUPERIORITY_OR_OTHER|||||||0.45|TWO_SIDED||||||McNemar|||Antisepsis and Control sides were compared.||||0.45
72590581|NCT01286168|144713219|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED||||||Mixed Models Analysis|||Antisepsis and Control sides were compared. Unadjusted p-value from generalized linear mixed effect model accounting for correlation among multiple drains from the same patient.||||0.02
72590582|NCT01286168|144713219|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED||||||Mixed Models Analysis|||Antisepsis and Control sides were compared. P-value from generalized linear mixed effect model accounting for correlation among multiple drains from the same patient. P-value was adjusted for side- and drain-specific variables: indication (cancer or prophylaxis), operation (mastectomy only, mastectomy+SLNB, mastectomy +ALND), and drain duration.||||0.02
72590583|NCT01286168|144713220|SUPERIORITY_OR_OTHER|||||||0.004|||||||Likelihood-ratio test|||Antisepsis and Control sides were compared. Due to zero events in the antisepsis side for this endpoint, p-value was derived from likelihood-ratio test comparing the intercept only model to the model with intercept and treatment side included.||||0.004
72590584|NCT01286168|144713221|SUPERIORITY_OR_OTHER|||||||0.003|||||||Mixed Models Analysis|||Antisepsis and Control sides were compared. Unadjusted p-value from generalized linear mixed effect model accounting for correlation among multiple drains from the same patient.||||0.003
72590585|NCT01286168|144713221|SUPERIORITY_OR_OTHER|||||||0.003|||||||Mixed Models Analysis|||Antisepsis and Control sides were compared. P-value from generalized linear mixed effect model accounting for correlation among multiple drains from the same patient. P-value was adjusted for side- and drain-specific variables: indication (cancer or prophylaxis), operation (mastectomy only, mastectomy+SLNB, mastectomy +ALND), and drain duration.||||0.003
72590586|NCT03535194|144713230|SUPERIORITY||Risk Difference (RD)|73.5|||<|0.001|TWO_SIDED|95.0|68.2|78.7|||Cochran-Mantel-Haenszel|||||78.7|68.2|<0.001
72590587|NCT03535194|144713231|SUPERIORITY||Risk Difference (RD)|68.0|||<|0.001|TWO_SIDED|95.0|62.7|73.3|||Cochran-Mantel-Haenszel|||||73.3|62.7|<0.001
72590588|NCT03535194|144713232|SUPERIORITY||Risk Difference (RD)|81.6|||<|0.001|TWO_SIDED|95.0|76.1|87.0|||Cochran-Mantel-Haenszel|||||87.0|76.1|<0.001
72590589|NCT03535194|144713233|SUPERIORITY||Risk Difference (RD)|51.7|||<|0.001|TWO_SIDED|95.0|47.6|55.8|||Cochran-Mantel-Haenszel|||||55.8|47.6|<0.001
72590590|NCT03535194|144713234|SUPERIORITY||Risk Difference (RD)|23.2|||<|0.001|TWO_SIDED|95.0|19.3|27.1|||Cochran-Mantel-Haenszel|||||27.1|19.3|<0.001
72414309|NCT03069482|144337770|SUPERIORITY||Trimmed mean difference|7.79514|STANDARD_ERROR_OF_MEAN|2.16||0.109|TWO_SIDED|95.0|-1.867|17.457|||Yuen's trimmed means t-test|||||17.457|-1.867|0.109
72590591|NCT03535194|144713235|SUPERIORITY||Risk Difference (RD)|53.5|||<|0.001|TWO_SIDED|95.0|47.7|59.3|||Cochran-Mantel-Haenszel|||||59.3|47.7|<0.001
72590592|NCT03535194|144713236|SUPERIORITY||LSMean Difference|-4.94|STANDARD_ERROR_OF_MEAN|1.05|<|0.001|TWO_SIDED|95.0|-7.01|-2.88|||Mixed Models Analysis|||||-2.88|-7.01|<0.001
72590593|NCT03535194|144713237|SUPERIORITY||LSMean Difference|-15.15|STANDARD_ERROR_OF_MEAN|0.692|<|0.001|TWO_SIDED|95.0|-16.51|-13.8|||Mixed Models Analysis|||||-13.80|-16.51|<0.001
72590594|NCT03535194|144713238|SUPERIORITY||LSMean Difference|-9.59|STANDARD_ERROR_OF_MEAN|1.55|<|0.001|TWO_SIDED|95.0|-12.63|-6.55|||Mixed Models Analysis|||||-6.55|-12.63|<0.001
72590595|NCT03535194|144713239|SUPERIORITY||LSMean Difference|3.46|STANDARD_ERROR_OF_MEAN|0.642|<|0.001|TWO_SIDED|95.0|2.2|4.72|||ANCOVA|||||4.72|2.20|<0.001
72590596|NCT03535194|144713240|SUPERIORITY||LSMean Difference|3.96|STANDARD_ERROR_OF_MEAN|0.711|<|0.001|TWO_SIDED|95.0|2.56|5.35|||ANCOVA|||||5.35|2.56|<0.001
72590597|NCT03535194|144713241|SUPERIORITY||Risk Difference (RD)|65.0|||<|0.001|TWO_SIDED|95.0|59.3|70.8|||Cochran-Mantel-Haenszel|||||70.8|59.3|<0.001
72590598|NCT03535194|144713243|SUPERIORITY||LSMean Difference|-0.5|STANDARD_ERROR_OF_MEAN|2.255||0.826|TWO_SIDED|95.0|-4.96|3.96|||ANCOVA|||||3.96|-4.96|0.826
72590599|NCT03535194|144713245|NON_INFERIORITY|10% non-inferiority margin was used.|Risk Difference (RD)|3.3|||<|0.0001|TWO_SIDED|95.0|-1.4|7.9|||Cochran-Mantel-Haenszel|||||7.9|-1.4|<0.0001
72590600|NCT03535194|144713246|NON_INFERIORITY|10% non-inferiority margin was used.|Risk Difference (RD)|1.6|||<|0.0001|TWO_SIDED|95.0|-3.4|6.6|||Cochran-Mantel-Haenszel|||||6.6|-3.4|<0.0001
72590601|NCT00979875|144713294|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean Ratio|2.08|||<|0.0001|TWO_SIDED|90.0|1.7|2.55||Statistical testing was considered exploratory, with no adjustment for inflation of Type 1 error due to multiplicity of testing.|Mixed Models Analysis|Analysis performed using mixed model with fixed effect for treatment. A compound symmetry covariance matrix among repeated measurements was assumed.||||2.55|1.70|<0.0001
72590602|NCT00979875|144713294|SUPERIORITY_OR_OTHER||Geometric Least Squares Means Ratio|5.26|||<|0.0001|TWO_SIDED|90.0|3.88|7.12||Statistical testing was considered exploratory, with no adjustment for inflation of Type 1 error due to multiplicity of testing.|Mixed Models Analysis|Analysis performed using mixed model with fixed effect for treatment. A compound symmetry covariance matrix among repeated measurements was assumed.||||7.12|3.88|<0.0001
72590603|NCT00979875|144713294|SUPERIORITY_OR_OTHER||Geometric Least Squares Means Ratio|4.14|||<|0.0001|TWO_SIDED|90.0|3.05|5.6||Statistical testing was considered exploratory, with no adjustment for inflation of Type 1 error due to multiplicity of testing.|Mixed Models Analysis|Analysis performed using mixed model with fixed effect for treatment. A compound symmetry covariance matrix among repeated measurements was assumed.||||5.60|3.05|<0.0001
72414310|NCT03069482|144337771|SUPERIORITY||Trimmed mean difference|2.22222|STANDARD_ERROR_OF_MEAN|1.75||0.50537|TWO_SIDED|95.0|-4.492|8.943|||Yuen's trimmed means t-test|||||8.943|-4.492|0.50537
72414311|NCT03069482|144337772|SUPERIORITY||Trimmed mean difference|5.83333|STANDARD_ERROR_OF_MEAN|2.3||0.27411|TWO_SIDED|95.0|-4.88|16.54|||Yuen's trimmed means t-test|||||16.54|-4.88|0.27411
72414312|NCT04537923|144337818|NON_INFERIORITY|0.3% noninferiority margin.|LS Mean Difference|-1.1|||<|0.001|TWO_SIDED|95.0|-1.24|-0.97|||Mixed Models Analysis|||||-0.97|-1.24|<0.001
72590604|NCT00979875|144713295|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-38.93|||<|0.0001|TWO_SIDED|90.0|-53.31|-24.55||Statistical testing was considered exploratory, with no adjustment for inflation of Type 1 error due to multiplicity of testing.|ANOVA|Analysis performed using mixed model with fixed effect for treatment. A compound symmetry covariance matrix among repeated measurements was assumed.||||-24.55|-53.31|<0.0001
72590605|NCT00979875|144713295|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-26.43||||0.0032|TWO_SIDED|90.0|-40.81|-12.05||Statistical testing was considered exploratory, with no adjustment for inflation of Type 1 error due to multiplicity of testing.|ANOVA|Analysis performed using mixed model with fixed effect for treatment. A compound symmetry covariance matrix among repeated measurements was assumed.||||-12.05|-40.81|0.0032
72590606|NCT00979875|144713295|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-42.14|||<|0.0001|TWO_SIDED|90.0|-56.53|-27.76||Statistical testing was considered exploratory, with no adjustment for inflation of Type 1 error due to multiplicity of testing.|ANOVA|Analysis performed using mixed model with fixed effect for treatment. A compound symmetry covariance matrix among repeated measurements was assumed.||||-27.76|-56.53|<0.0001
72590607|NCT02738879|144713300|NON_INFERIORITY|Hypothesis A: After 30 weeks, continuing sitagliptin is non-inferior relative to withdrawing sitagliptin on the change from baseline in A1C. Non-inferiority is declared if the upper bound of the two-sided 95% CI for the difference is less than 0.3%.|Between Group Difference in the LSM|-0.46|||||TWO_SIDED|95.0|-0.58|-0.34|||LDA|||A longitudinal data analysis (LDA) model included terms for treatment, AHA treatment at screening (Met + DPP-4i, Met + DPP-4i + SU, Met + SU), time, and the interactions of time by treatment and of time by AHA treatment at screening. Least Squares Means = LSM||-0.34|-0.58|
72590608|NCT02738879|144713300|SUPERIORITY|Hypothesis B: After 30 weeks, continuing sitagliptin results in a greater reduction of A1C relative to withdrawing sitagliptin.|Between Group Difference in the LSM|-0.46|||<|0.001|TWO_SIDED|95.0|-0.58|-0.34|||LDA|||A LDA model included terms for treatment, AHA treatment at screening (Met + DPP-4i, Met + DPP-4i + SU, Met + SU), time, and the interactions of time by treatment and of time by AHA treatment at screening.||-0.34|-0.58|< 0.001
72590609|NCT02738879|144713301|SUPERIORITY||Event Rate Ratio|0.73|||=|0.039|TWO_SIDED|95.0|0.54|0.98|||Negative Binomial Model|||Calculated via the Negative Binomial Model including terms for treatment, race (i.e., White and Other), region (i.e., Europe, North America, and Other), AHA treatment at screening, baseline A1C value and baseline body weight and an offset for follow-up time (on the natural log scale).||0.98|0.54|= 0.039
72590610|NCT02738879|144713302|OTHER|95% CI|Between Group Difference in Percentages|-0.3|||||TWO_SIDED|95.0|-2.3|1.7|||Miettinen & Nurminen|||||1.7|-2.3|
72590611|NCT02738879|144713303|SUPERIORITY||Between Group Difference in Percentages|-4.1|||=|0.25|TWO_SIDED|95.0|-11.2|2.9|||Miettinen and Nurminen|||||2.9|-11.2|= 0.250
72590612|NCT02738879|144713304|SUPERIORITY||Between Group Difference in the LSM|-8.0|||=|0.016|TWO_SIDED|95.0|-14.6|-1.5|||LDA model|||The analysis is based on a LDA model including terms for treatment, AHA treatment at screening (Met + DPP-4i, Met + DPP-4i + SU, Met + SU), time, and the interactions of time by treatment and of time by AHA treatment at screening.||-1.5|-14.6|= 0.016
72590613|NCT02738879|144713305|SUPERIORITY||Event Rate Ratio|0.81|||=|0.041|TWO_SIDED|95.0|0.67|0.99|||Negative Binomial Model|||Negative Binomial Model including terms for treatment, race (i.e., White and Other), region (i.e., Europe, North America, and Other), AHA treatment at screening, baseline A1C value and baseline body weight and an offset for follow-up time (on the natural log scale).||0.99|0.67|= 0.041
72414313|NCT04537923|144337819|NON_INFERIORITY|0.3% noninferiority margin.|LS Mean Difference|-0.89|||<|0.001|TWO_SIDED|95.0|-1.08|-0.7|||Mixed Models Analysis|||||-0.70|-1.08|<0.001
72590614|NCT02738879|144713306|SUPERIORITY||Event Rate Ratio|0.83|||=|0.473|TWO_SIDED|95.0|0.51|1.37|||Negative Binomial Model|||Negative Binomial Model including terms for treatment, race (i.e., White and Other), region (i.e., Europe, North America, and Other), AHA treatment at screening, baseline A1C value and baseline body weight and an offset for follow-up time (on the natural log scale).||1.37|0.51|= 0.473
72414314|NCT04537923|144337819|NON_INFERIORITY|0.3% noninferiority margin.|LS Mean Difference|-1.11|||<|0.001|TWO_SIDED|95.0|-1.3|-0.92|||Mixed Models Analysis|||||-0.92|-1.30|<0.001
72414315|NCT04537923|144337819|NON_INFERIORITY|0.3% noninferiority margin.|LS Mean Difference|-1.3|||<|0.001|TWO_SIDED|95.0|-1.49|-1.11|||Mixed Models Analysis|||||-1.11|-1.49|<0.001
72590615|NCT02738879|144713307|SUPERIORITY||Between Group Difference in Percentages|-1.2|||=|0.624|TWO_SIDED|95.0|-6.2|3.7|||Miettinen and Nurminen|||Percentages and difference in percentages were calculated via the Miettinen and Nurminen stratified by AHA treatment at screening. Includes imputed events after participants discontinued from the study medication, using a Gamma frailty model. The bootstrap method was used to obtain the CI and p-value.||3.7|-6.2|= 0.624
72590616|NCT02738879|144713308|SUPERIORITY||Between Group Difference in Percentages|18.8|||<|0.001|TWO_SIDED|95.0|11.6|25.7|||Miettinen and Nurminen|||||25.7|11.6|< 0.001
72590617|NCT02738879|144713309|SUPERIORITY||Between Group Difference in the LSM|-6.5|||=|0.02|TWO_SIDED|95.0|-11.9|-1.0|||LDA|||Analysis was based on a LDA model including terms for treatment, AHA treatment at screening (Met + DPP-4i, Met + DPP-4i + SU, Met + SU), time, and the interactions of time by treatment and of time by AHA treatment at screening.||-1.0|-11.9|= 0.020
72590618|NCT02738879|144713310|OTHER|95% CI|Between Group Difference in Percentages|-2.1|||||TWO_SIDED|95.0|-9.1|5.0|||Miettinen & Nurminen|||||5.0|-9.1|
72414316|NCT04537923|144337820|SUPERIORITY||Odds Ratio (OR)|3.13|||<|0.0001|TWO_SIDED|95.0|2.25|4.36|||Regression, Logistic|||||4.36|2.25|<0.0001
72590619|NCT02738879|144713311|SUPERIORITY||Event Rate Ratio|0.76|||=|0.394|TWO_SIDED|95.0|0.4|1.44|||Negative Binomial Model|||The analysis was calculated via the Negative Binomial Model including terms for treatment, race (i.e., White and Other), region (i.e., Europe, North America, and Other), AHA treatment at screening, baseline A1C value and baseline body weight and an offset for follow-up time (on the natural log scale).||1.44|0.40|= 0.394
72590620|NCT02738879|144713312|SUPERIORITY||Between Group Difference in Percentages|-1.2|||=|0.74|TWO_SIDED|95.0|-8.2|5.8|||Miettinen and Nurminen|||The analysis included imputed events after participants discontinued from the study medication, using a Gamma frailty model. Proportions and difference in proportions were calculated via the Miettinen and Nurminen stratified by AHA treatment at screening. The bootstrap method was used to obtain the CI and p-value.||5.8|-8.2|= 0.740
72590621|NCT02738879|144713313|SUPERIORITY||Between Group Difference in Percentages|-0.7|||=|0.712|TWO_SIDED|95.0|-4.7|3.2|||Miettinen and Nurminen|||Percentages and difference in percentages were calculated via the Miettinen and Nurminen stratified by AHA treatment at screening. The analysis included imputed events after subjects discontinued from the study medication, using a Gamma frailty model. The bootstrap method was used to obtain the CI and p-value.||3.2|-4.7|= 0.712
72590622|NCT02738879|144713314|SUPERIORITY||Between Group Difference in Percentages|5.3|||=|0.03|TWO_SIDED|95.0|0.5|10.1|||Miettinen and Nurminen|||||10.1|0.5|= 0.030
72590623|NCT01730534|144713334|SUPERIORITY||Hazard Ratio (HR)|0.93||||0.172||95.0|0.84|1.03|||Regression, Cox|||||1.03|0.84|0.172
72590624|NCT01730534|144713335|SUPERIORITY||Hazard Ratio (HR)|0.83||||0.005||95.0|0.73|0.95|||Regression, Cox|||||0.95|0.73|0.005
72590625|NCT01730534|144713336|SUPERIORITY||Hazard Ratio (HR)|0.76|||<|0.001||95.0|0.67|0.87|||Regression, Cox|||||0.87|0.67|<0.001
72590626|NCT01730534|144713337|SUPERIORITY||Hazard Ratio (HR)|0.93||||0.198||95.0|0.82|1.04|||Regression, Cox|||||1.04|0.82|0.198
72590627|NCT01895608|144713338|OTHER|non-parametric statistic: Mann-Whitney U test for independent samples||||||0.562|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: There will not be a difference in improvement in walking under dual-task conditions following balance rehabilitation that incorporates dual-task practice compared to standard balance rehabilitation.||||0.562
72590628|NCT01895608|144713338|OTHER|||||||0.414|||||||Wilcoxon (Mann-Whitney)|non-parametric statistical analysis: Mann Whitney U Test for independent samples||Null hypothesis: There will not be a difference in improvement in walking under dual-task conditions following cognitive training that incorporates speed of processing tasks compared to general cognitive training.||||0.414
72590629|NCT01895608|144713339|OTHER|non-parametric statistical analysis: Mann Whitney U Test for independent samples||||||0.181|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: There will not be a difference in improvement in walking under dual-task conditions following balance rehabilitation that incorporates dual-task practice compared to standard balance rehabilitation.||||0.181
72590630|NCT01895608|144713339|OTHER|non-parametric statistical analysis: Mann Whitney U Test for independent samples||||||1|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: There will not be a difference in improvement in walking under dual-task conditions following cognitive training that incorporates speed of processing tasks compared to general cognitive training.||||1.000
72590631|NCT01895608|144713340|OTHER|non-parametric statistical analysis: Mann Whitney U Test for independent samples||||||1|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: There will not be a difference in improvement in fall risk as measured by dynamic gait index following balance rehabilitation that incorporates dual-task practice compared to standard balance rehabilitation.||||1.000
72590632|NCT01895608|144713340|OTHER|non-parametric statistical analysis: Mann Whitney U Test for independent samples||||||0.662|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: There will not be a difference in improvement in fall risk as measured by dynamic gait index following cognitive training that incorporates speed of processing tasks compared to general cognitive training.||||0.662
72590633|NCT01895608|144713341|OTHER|non-parametric statistical analysis: Mann Whitney U Test for independent samples||||||0.05|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: There will not be a difference in improvement in static balance as measured by sensory organization test following balance rehabilitation that incorporates dual-task practice compared to standard balance rehabilitation.||||0.05
72414317|NCT04537923|144337820|SUPERIORITY||Odds Ratio (OR)|6.16|||<|0.0001|TWO_SIDED|95.0|4.27|8.88|||Regression, Logistic|||||8.88|4.27|<0.0001
72414318|NCT04537923|144337820|SUPERIORITY||Odds Ratio (OR)|7.94|||<|0.0001|TWO_SIDED|95.0|5.37|11.75|||Regression, Logistic|||||11.75|5.37|<0.0001
72414319|NCT04537923|144337821|SUPERIORITY||LS Mean Difference|-10.7|||<|0.001|TWO_SIDED|95.0|-11.5|-9.9|||Mixed Models Analysis|||||-9.9|-11.5|<0.001
72414320|NCT04537923|144337821|SUPERIORITY||LS Mean Difference|-13.7|||<|0.001|TWO_SIDED|95.0|-14.5|-12.9|||Mixed Models Analysis|||||-12.9|-14.5|<0.001
72414321|NCT04537923|144337821|SUPERIORITY||LS Mean Difference|-15.9|||<|0.001|TWO_SIDED|95.0|-16.7|-15.0|||Mixed Models Analysis|||||-15.0|-16.7|<0.001
72590634|NCT01895608|144713341|OTHER|non-parametric statistical analysis: Mann Whitney U Test for independent samples||||||0.171|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: There will not be a difference in improvement in static balance as measured by sensory organization test following cognitive training that incorporates speed of processing tasks compared to general cognitive training.||||0.171
72590635|NCT01895608|144713342|OTHER|non-parametric statistical analysis: Mann Whitney U Test for independent samples||||||0.313|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: There will not be a difference in improvement in gait speed following balance rehabilitation that incorporates dual-task practice compared to standard balance rehabilitation.||||0.313
72590636|NCT01895608|144713342|OTHER|non-parametric statistical analysis: Mann Whitney U Test for independent samples||||||0.852|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: There will not be a difference in improvement in gait speed following cognitive training that incorporates speed of processing tasks compared to general cognitive training.||||0.852
72590637|NCT01895608|144713343|OTHER|non-parametric statistical analysis: Mann Whitney U Test for independent samples||||||0.263|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: There will not be a difference in improvement in balance confidence following balance rehabilitation that incorporates dual-task practice compared to standard balance rehabilitation.||||0.263
72590638|NCT01895608|144713343|OTHER|non-parametric statistical analysis: Mann Whitney U Test for independent samples||||||0.181|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: There will not be a difference in improvement in balance confidence following cognitive training that incorporates speed of processing tasks compared to general cognitive training.||||0.181
72590639|NCT02833844|144713347|SUPERIORITY||treatment difference|-56.92|STANDARD_ERROR_OF_MEAN|2.36|<|0.0001|TWO_SIDED|95.0|-61.55|-52.28||Multiplicity adjustment was based on the combination of sequential testing, the fallback procedure, and the Hochberg procedure.|repeated measures linear effects model|Per protocol, the adjusted p-value is significant if less than the familywise error rate of 0.05.|Treatment difference uses placebo as the reference.|||-52.28|-61.55|< 0.0001
72590640|NCT02833844|144713348|SUPERIORITY||treatment difference|-75.2|STANDARD_ERROR_OF_MEAN|3.5|<|0.0001|TWO_SIDED|95.0|-82.1|-68.4||Multiplicity adjustment was based on the combination of sequential testing, the fallback procedure, and the Hochberg procedure.|repeated measures linear effects model|Per protocol, the adjusted p-value is significant if less than the familywise error rate of 0.05.|Treatment difference uses placebo as the reference.|||-68.4|-82.1|< 0.0001
72590641|NCT02833844|144713349|SUPERIORITY||treatment difference|65.4|||<|0.0001|TWO_SIDED|95.0|57.8|71.1||Based on Cochran-Mantel-Haenszel test stratified by statin use stratification factor. For testing, nonachievement was imputed for participants with a missing value.|Cochran-Mantel-Haenszel|Per protocol, the adjusted p-value is significant if less than the familywise error rate of 0.05.|Treatment difference uses placebo as reference.|Multiplicity adjustment was based on the combination of sequential testing, the fallback procedure, and the Hochberg procedure.||71.1|57.8|< 0.0001
72590642|NCT02833844|144713350|SUPERIORITY||treatment difference|71.9|||<|0.0001|TWO_SIDED|95.0|65.7|76.7||Based on Cochran-Mantel-Haenszel test stratified by statin use stratification factor. For testing, nonachievement was imputed for participants with a missing value.|Cochran-Mantel-Haenszel|Per protocol, the adjusted p-value is significant if less than the familywise error rate of 0.05.|Treatment difference uses placebo as a reference.|Multiplicity adjustment was based on the combination of sequential testing, the fallback procedure, and the Hochberg procedure.||76.7|65.7|< 0.0001
72414322|NCT04537923|144337822|SUPERIORITY||LS Mean Difference|-23.2|||<|0.001|TWO_SIDED|95.0|-30.8|-15.7|||Mixed Models Analysis|||||-15.7|-30.8|<0.001
72590643|NCT02833844|144713351|SUPERIORITY||treatment difference|-50.94|STANDARD_ERROR_OF_MEAN|2.01|<|0.0001|TWO_SIDED|95.0|-54.88|-46.99||Multiplicity adjustment was based on the combination of sequential testing, the fallback procedure, and the Hochberg procedure.|repeated measures linear effects model|Per protocol, the adjusted p-value is significant if less than the familywise error rate of 0.05.|Treatment difference uses placebo as the reference.|||-46.99|-54.88|< 0.0001
72590644|NCT02833844|144713352|SUPERIORITY||treatment difference|-47.73|STANDARD_ERROR_OF_MEAN|1.72|<|0.0001|TWO_SIDED|95.0|-51.11|-44.35||Multiplicity adjustment was based on the combination of sequential testing, the fallback procedure, and the Hochberg procedure.|repeated measures linear effects model|Per protocol, the adjusted p-value is significant if less than the familywise error rate of 0.05.|Treatment difference uses placebo as the reference.|||-44.35|-51.11|< 0.0001
72414323|NCT04537923|144337822|SUPERIORITY||LS Mean Difference|-33.0|||<|0.001|TWO_SIDED|95.0|-40.6|-25.4|||Mixed Models Analysis|||||-25.4|-40.6|<0.001
72590645|NCT02833844|144713353|SUPERIORITY||treatment difference|-38.12|STANDARD_ERROR_OF_MEAN|1.62|<|0.0001|TWO_SIDED|95.0|-41.3|-34.94||Multiplicity adjustment was based on the combination of sequential testing, the fallback procedure, and the Hochberg procedure.|repeated measures linear effects model|Per protocol, the adjusted p-value is significant if less than the familywise error rate of 0.05.|Treatment difference uses placebo as the reference.|||-34.94|-41.30|< 0.0001
72590646|NCT02833844|144713354|SUPERIORITY||treatment difference|-26.78|STANDARD_ERROR_OF_MEAN|3.76|<|0.0001|TWO_SIDED|95.0|-34.17|-19.4||Multiplicity adjustment was based on the combination of sequential testing, the fallback procedure, and the Hochberg procedure.|repeated measures linear effects model|Per protocol, the adjusted p-value is significant if less than the familywise error rate of 0.05.|Treatment difference uses placebo as the reference.|||-19.40|-34.17|< 0.0001
72590647|NCT02833844|144713355|SUPERIORITY||treatment difference|-22.46|STANDARD_ERROR_OF_MEAN|4.36|<|0.0001|TWO_SIDED|95.0|-31.03|-13.88||Multiplicity adjustment was based on the combination of sequential testing, the fallback procedure, and the Hochberg procedure.|repeated measures linear effects model|Per protocol, the adjusted p-value is significant if less than the familywise error rate of 0.05.|Treatment difference uses placebo as the reference.|||-13.88|-31.03|< 0.0001
72590648|NCT02833844|144713356|SUPERIORITY||treatment difference|8.36|STANDARD_ERROR_OF_MEAN|1.8|<|0.0001|TWO_SIDED|95.0|4.83|11.89||Multiplicity adjustment was based on the combination of sequential testing, the fallback procedure, and the Hochberg procedure.|repeated measures linear effects model|Per protocol, the adjusted p-value is significant if less than the familywise error rate of 0.05.|Treatment difference uses placebo as the reference.|||11.89|4.83|< 0.0001
72590649|NCT02833844|144713357|SUPERIORITY||treatment difference|-22.15|STANDARD_ERROR_OF_MEAN|4.01|<|0.0001|TWO_SIDED|95.0|-30.04|-14.26||Multiplicity adjustment was based on the combination of sequential testing, the fallback procedure, and the Hochberg procedure.|repeated measures linear effects model|Per protocol, the adjusted p-value is significant if less than the familywise error rate of 0.05.|Treatment difference uses placebo as the reference.|||-14.26|-30.04|< 0.0001
72590650|NCT03369067|144713358|OTHER|||||||0.01||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||0.010
72590651|NCT03369067|144713358|OTHER|||||||0.089||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with age group as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||0.089
72590652|NCT03369067|144713358|OTHER|||||||0.024||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode and age group as fixed factors. P value \<0.05 was considered significant.|ANOVA|||||||0.024
72590653|NCT03369067|144713359|OTHER|||||||0.095||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||0.095
72590654|NCT03369067|144713359|OTHER|||||||0.104||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with age group as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||0.104
72590655|NCT03369067|144713359|OTHER|||||||0.042||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode and age group as fixed factors. P value \<0.05 was considered significant.|ANOVA|||||||0.042
72590656|NCT03369067|144713360|OTHER||||||<|0.001||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||<0.001
72590657|NCT03369067|144713360|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with age group as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||>0.2
72590658|NCT03369067|144713360|OTHER|||||||0.065||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode and age group as fixed factors. P value \<0.05 was considered significant.|ANOVA|||||||0.065
72590659|NCT03369067|144713361|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||>0.2
72590660|NCT03369067|144713361|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with age group as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||>0.2
72590661|NCT03369067|144713361|OTHER|||||||0.063||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode and age group as fixed factors. P value \<0.05 was considered significant.|ANOVA|||||||0.063
72590662|NCT03369067|144713362|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with the treatment mode as a fixed factor. P value \<0.05 was considered significant.|Wilcoxon (Mann-Whitney)|||||||>0.2
72590663|NCT03369067|144713362|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with age group as a fixed factor. P value \<0.05 was considered significant.|Wilcoxon (Mann-Whitney)|||||||>0.2
72590664|NCT03369067|144713362|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with the treatment mode and age group as fixed factors. P value \<0.05 was considered significant.|Wilcoxon (Mann-Whitney)|||||||>0.2
72590665|NCT03369067|144713363|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with the treatment mode as a fixed factor. P value \<0.05 was considered significant.|Wilcoxon (Mann-Whitney)|||||||>0.2
72590666|NCT03369067|144713363|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with age group as a fixed factor. P value \<0.05 was considered significant.|Wilcoxon (Mann-Whitney)|||||||>0.2
72590667|NCT03369067|144713363|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with the treatment mode and age group as fixed factors. P value \<0.05 was considered significant.|Wilcoxon (Mann-Whitney)|||||||>0.2
72590668|NCT03369067|144713364|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with the treatment mode as a fixed factor. P value \<0.05 was considered significant.|Wilcoxon (Mann-Whitney)|||||||>0.2
72590669|NCT03369067|144713364|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with age group as a fixed factor. P value \<0.05 was considered significant.|Wilcoxon (Mann-Whitney)|||||||>0.2
72590670|NCT03369067|144713364|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with the treatment mode and age group as fixed factors. P value \<0.05 was considered significant.|Wilcoxon (Mann-Whitney)|||||||>0.2
72590671|NCT03369067|144713365|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with the treatment mode as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||>0.2
72590672|NCT03369067|144713365|OTHER|||||||0.062||||||Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with age group as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||0.062
72590673|NCT03369067|144713365|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with the treatment mode and age group as fixed factors. P value \<0.05 was considered significant.|ANOVA|||||||>0.2
72590674|NCT03369067|144713366|OTHER|||||||0.015||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||0.015
72590675|NCT03369067|144713366|OTHER|||||||0.199||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with age group as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||0.199
72590676|NCT03369067|144713366|OTHER|||||||0.025||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode and age group as fixed factors. P value \<0.05 was considered significant.|ANOVA|||||||0.025
72590677|NCT03369067|144713367|OTHER|||||||0.059||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||0.059
72590678|NCT03369067|144713367|OTHER|||||||0.064||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with age group as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||0.064
72590679|NCT03369067|144713367|OTHER|||||||0.017||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode and age group as fixed factors. P value \<0.05 was considered significant.|ANOVA|||||||0.017
72590680|NCT03369067|144713368|OTHER|||||||0.034||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||0.034
72590681|NCT03369067|144713368|OTHER|||||||0.074||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with age group as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||0.074
72590682|NCT03369067|144713368|OTHER|||||||0.034||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode and age group as fixed factors. P value \<0.05 was considered significant.|ANOVA|||||||0.034
72590683|NCT03369067|144713369|OTHER|||||||0.023||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||0.023
72590684|NCT03369067|144713369|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with age group as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||>0.2
72590685|NCT03369067|144713369|OTHER|||||||0.016||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode and age group as fixed factors. P value \<0.05 was considered significant.|ANOVA|||||||0.016
72590686|NCT03369067|144713370|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||>0.2
72590687|NCT03369067|144713370|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with age group as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||>0.2
72590688|NCT03369067|144713370|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode and age group as fixed factors. P value \<0.05 was considered significant.|ANOVA|||||||>0.2
72590689|NCT03369067|144713371|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||>0.2
72590690|NCT03369067|144713371|OTHER|||||||0.081||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with age group as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||0.081
72590691|NCT03369067|144713371|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode and age group as fixed factors. P value \<0.05 was considered significant.|ANOVA|||||||>0.2
72590692|NCT03369067|144713372|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||>0.2
72414324|NCT04537923|144337822|SUPERIORITY||LS Mean Difference|-31.6|||<|0.001|TWO_SIDED|95.0|-39.3|-23.8|||Mixed Models Analysis|||||-23.8|-39.3|<0.001
72590693|NCT03369067|144713372|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with age group as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||>0.2
72590694|NCT03369067|144713372|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode and age group as fixed factors. P value \<0.05 was considered significant.|ANOVA|||||||>0.2
72590695|NCT03369067|144713373|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with the treatment mode as a fixed factor. P value \<0.05 was considered significant.|Wilcoxon (Mann-Whitney)|||||||>0.2
72590696|NCT03369067|144713373|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with age group as a fixed factor. P value \<0.05 was considered significant.|Wilcoxon (Mann-Whitney)|||||||>0.2
72590697|NCT03369067|144713373|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with the treatment mode and age group as fixed factors. P value \<0.05 was considered significant.|Wilcoxon (Mann-Whitney)|||||||>0.2
72590698|NCT03369067|144713374|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with the treatment mode as a fixed factor. P value \<0.05 was considered significant.|Wilcoxon (Mann-Whitney)|||||||>0.2
72590699|NCT03369067|144713374|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with age group as a fixed factor. P value \<0.05 was considered significant.|Wilcoxon (Mann-Whitney)|||||||>0.2
72590700|NCT03369067|144713374|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with the treatment mode and age group as fixed factors. P value \<0.05 was considered significant.|Wilcoxon (Mann-Whitney)|||||||>0.2
72590701|NCT03369067|144713375|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with the treatment mode as a fixed factor. P value \<0.05 was considered significant.|Wilcoxon (Mann-Whitney)|||||||>0.2
72590702|NCT03369067|144713375|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with age group as a fixed factor. P value \<0.05 was considered significant.|Wilcoxon (Mann-Whitney)|||||||>0.2
72590703|NCT03369067|144713375|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with the treatment mode and age group as fixed factors. P value \<0.05 was considered significant.|Wilcoxon (Mann-Whitney)|||||||>0.2
72590704|NCT03369067|144713376|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with the treatment mode as a fixed factor. P value \<0.05 was considered significant.|Wilcoxon (Mann-Whitney)|||||||>0.2
72590705|NCT03369067|144713376|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with age group as a fixed factor. P value \<0.05 was considered significant.|Wilcoxon (Mann-Whitney)|||||||>0.2
72590706|NCT03369067|144713376|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with the treatment mode and age group as fixed factors. P value \<0.05 was considered significant.|Wilcoxon (Mann-Whitney)|||||||>0.2
72590707|NCT03369067|144713377|OTHER|||||||0.124||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||0.124
72590708|NCT03369067|144713377|OTHER|||||||0.187||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with age group as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||0.187
72590709|NCT03369067|144713377|OTHER|||||||0.04||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode and age group as fixed factors. P value \<0.05 was considered significant.|ANOVA|||||||0.040
72590710|NCT03369067|144713378|OTHER|||||||0.108||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||0.108
72590711|NCT03369067|144713378|OTHER|||||||0.053||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with age group as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||0.053
72590712|NCT03369067|144713378|OTHER|||||||0.01||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode and age group as fixed factors. P value \<0.05 was considered significant.|ANOVA|||||||0.010
72590713|NCT03369067|144713379|OTHER|||||||0.08||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||0.080
72590714|NCT03369067|144713379|OTHER|||||||0.038||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with age group as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||0.038
72590715|NCT03369067|144713379|OTHER|||||||0.016||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode and age group as fixed factors. P value \<0.05 was considered significant.|ANOVA|||||||0.016
72590716|NCT03369067|144713380|OTHER|||||||0.111||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||0.111
72414325|NCT04537923|144337823|SUPERIORITY||LS Mean Difference|-0.9||||0.682|TWO_SIDED|95.0|-5.0|3.3|||Mixed Models Analysis|||||3.3|-5.0|0.682
72590717|NCT03369067|144713380|OTHER|||||||0.13||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with age group as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||0.130
72590718|NCT03369067|144713380|OTHER|||||||0.017||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode and age group as fixed factors. P value \<0.05 was considered significant.|ANOVA|||||||0.017
72590719|NCT03369067|144713381|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||>0.2
72590720|NCT03369067|144713381|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with age group as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||>0.2
72590721|NCT03369067|144713381|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode and age group as fixed factors. P value \<0.05 was considered significant.|ANOVA|||||||>0.2
72590722|NCT03369067|144713382|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||>0.2
72590723|NCT03369067|144713382|OTHER|||||||0.044||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with age group as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||0.044
72590724|NCT03369067|144713382|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode and age group as fixed factors. P value \<0.05 was considered significant.|ANOVA|||||||>0.2
72590725|NCT03369067|144713383|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||>0.2
72590726|NCT03369067|144713383|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with age group as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||>0.2
72590727|NCT03369067|144713383|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode and age group as fixed factors. P value \<0.05 was considered significant.|ANOVA|||||||>0.2
72590728|NCT03369067|144713384|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with the treatment mode as a fixed factor. P value \<0.05 was considered significant.|Wilcoxon (Mann-Whitney)|||||||>0.2
72590729|NCT03369067|144713384|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with age group as a fixed factor. P value \<0.05 was considered significant.|Wilcoxon (Mann-Whitney)|||||||>0.2
72590730|NCT03369067|144713384|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with the treatment mode and age group as fixed factors. P value \<0.05 was considered significant.|Wilcoxon (Mann-Whitney)|||||||>0.2
72590731|NCT03369067|144713385|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with the treatment mode as a fixed factor. P value \<0.05 was considered significant.|Wilcoxon (Mann-Whitney)|||||||>0.2
72590732|NCT03369067|144713385|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with age group as a fixed factor. P value \<0.05 was considered significant.|Wilcoxon (Mann-Whitney)|||||||>0.2
72590733|NCT03369067|144713385|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with the treatment mode and age group as fixed factors. P value \<0.05 was considered significant.|Wilcoxon (Mann-Whitney)|||||||>0.2
72590734|NCT03369067|144713386|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with the treatment mode as a fixed factor. P value \<0.05 was considered significant.|Wilcoxon (Mann-Whitney)|||||||>0.2
72590735|NCT03369067|144713386|OTHER|||||||0.141||||||Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with age group as a fixed factor. P value \<0.05 was considered significant.|Wilcoxon (Mann-Whitney)|||||||0.141
72590736|NCT03369067|144713386|OTHER|||||||0.149||||||Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with the treatment mode and age group as fixed factors. P value \<0.05 was considered significant.|Wilcoxon (Mann-Whitney)|||||||0.149
72590737|NCT03369067|144713387|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with the treatment mode as a fixed factor. P value \<0.05 was considered significant.|Wilcoxon (Mann-Whitney)|||||||>0.2
72590738|NCT03369067|144713387|OTHER|||||||0.094||||||Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with age group as a fixed factor. P value \<0.05 was considered significant.|Wilcoxon (Mann-Whitney)|||||||0.094
72590739|NCT03369067|144713387|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with the treatment mode and age group as fixed factors. P value \<0.05 was considered significant.|Wilcoxon (Mann-Whitney)|||||||>0.2
72590740|NCT03369067|144713388|OTHER||||||<|0.001||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||<0.001
72590741|NCT03369067|144713388|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with age group as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||>0.2
72590742|NCT03369067|144713388|OTHER|||||||0.033||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode and age group as fixed factors. P value \<0.05 was considered significant.|ANOVA|||||||0.033
72590743|NCT03369067|144713389|OTHER|||||||0.001||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||0.001
72590744|NCT03369067|144713389|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with age group as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||>0.2
72590745|NCT03369067|144713389|OTHER|||||||0.111||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode and age group as fixed factors. P value \<0.05 was considered significant.|ANOVA|||||||0.111
72590746|NCT03369067|144713390|OTHER|||||||0.118||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||0.118
72590747|NCT03369067|144713390|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with age group as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||>0.2
72414326|NCT04537923|144337823|SUPERIORITY||LS Mean Difference|-5.6||||0.01|TWO_SIDED|95.0|-9.9|-1.4|||Mixed Models Analysis|||||-1.4|-9.9|0.010
72414327|NCT04537923|144337823|SUPERIORITY||LS Mean Difference|-11.8|||<|0.001|TWO_SIDED|95.0|-16.0|-7.5|||Mixed Models Analysis|||||-7.5|-16.0|<0.001
72590748|NCT03369067|144713390|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode and age group as fixed factors. P value \<0.05 was considered significant.|ANOVA|||||||>0.2
72590749|NCT03369067|144713391|OTHER|||||||0.116||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||0.116
72590750|NCT03369067|144713391|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with age group as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||>0.2
72590751|NCT03369067|144713391|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode and age group as fixed factors. P value \<0.05 was considered significant.|ANOVA|||||||>0.2
72590752|NCT03369067|144713392|OTHER|||||||0.005||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||0.005
72590753|NCT03369067|144713392|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with age group as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||>0.2
72590754|NCT03369067|144713392|OTHER|||||||0.193||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode and age group as fixed factors. P value \<0.05 was considered significant.|ANOVA|||||||0.193
72590755|NCT03369067|144713393|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||>0.2
72590756|NCT03369067|144713393|OTHER|||||||0.106||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with age group as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||0.106
72590757|NCT03369067|144713393|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode and age group as fixed factors. P value \<0.05 was considered significant.|ANOVA|||||||>0.2
72414328|NCT04537923|144337824|SUPERIORITY||Odds Ratio (OR)|8.19|||<|0.001|TWO_SIDED|95.0|5.66|11.83|||Regression, Logistic|||||11.83|5.66|<0.001
72414329|NCT04537923|144337824|SUPERIORITY||Odds Ratio (OR)|16.9|||<|0.001|TWO_SIDED|95.0|11.44|24.96|||Regression, Logistic|||||24.96|11.44|<0.001
72414330|NCT04537923|144337824|SUPERIORITY||Odds Ratio (OR)|21.85|||<|0.001|TWO_SIDED|95.0|14.49|32.93|||Regression, Logistic|||||32.93|14.49|<0.001
72414331|NCT04537923|144337825|SUPERIORITY||Odds Ratio (OR)|28.25|||<|0.001|TWO_SIDED|95.0|18.36|43.46|||Regression, Logistic|||||43.46|18.36|<0.001
72414332|NCT04537923|144337825|SUPERIORITY||Odds Ratio (OR)|58.9|||<|0.001|TWO_SIDED|95.0|36.76|94.39|||Regression, Logistic|||||94.39|36.76|<0.001
72590758|NCT03369067|144713394|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||>0.2
72590759|NCT03369067|144713394|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with age group as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||>0.2
72590760|NCT03369067|144713394|OTHER|||||||0.157||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode and age group as fixed factors. P value \<0.05 was considered significant.|ANOVA|||||||0.157
72590761|NCT03369067|144713395|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||>0.2
72590762|NCT03369067|144713395|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with age group as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||>0.2
72590763|NCT03369067|144713395|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode and age group as fixed factors. P value \<0.05 was considered significant.|ANOVA|||||||>0.2
72590764|NCT03369067|144713396|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with the treatment mode as a fixed factor. P value \<0.05 was considered significant.|Wilcoxon (Mann-Whitney)|||||||>0.2
72590765|NCT03369067|144713396|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with age group as a fixed factor. P value \<0.05 was considered significant.|Wilcoxon (Mann-Whitney)|||||||>0.2
72590766|NCT03369067|144713396|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with the treatment mode and age group as fixed factors. P value \<0.05 was considered significant.|Wilcoxon (Mann-Whitney)|||||||>0.2
72414333|NCT04537923|144337825|SUPERIORITY||Odds Ratio (OR)|77.76|||<|0.001|TWO_SIDED|95.0|47.49|127.33|||Regression, Logistic|||||127.33|47.49|<0.001
72414334|NCT04537923|144337826|SUPERIORITY||LS Mean Difference|1.5||||0.005|TWO_SIDED|95.0|0.5|2.6|||ANCOVA|||||2.6|0.5|0.005
72590767|NCT03369067|144713397|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with the treatment mode as a fixed factor. P value \<0.05 was considered significant.|Wilcoxon (Mann-Whitney)|||||||>0.2
72590768|NCT03369067|144713397|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with age group as a fixed factor. P value \<0.05 was considered significant.|Wilcoxon (Mann-Whitney)|||||||>0.2
72590769|NCT03369067|144713397|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with the treatment mode and age group as fixed factors. P value \<0.05 was considered significant.|Wilcoxon (Mann-Whitney)|||||||>0.2
72590770|NCT03369067|144713398|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with the treatment mode as a fixed factor. P value \<0.05 was considered significant.|Wilcoxon (Mann-Whitney)|||||||>0.2
72590771|NCT03369067|144713398|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with age group as a fixed factor. P value \<0.05 was considered significant.|Wilcoxon (Mann-Whitney)|||||||>0.2
72590772|NCT03369067|144713398|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with the treatment mode and age group as fixed factors. P value \<0.05 was considered significant.|Wilcoxon (Mann-Whitney)|||||||>0.2
72590773|NCT03369067|144713399|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with the treatment mode as a fixed factor. P value \<0.05 was considered significant.|Wilcoxon (Mann-Whitney)|||||||>0.2
72590774|NCT03369067|144713399|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with age group as a fixed factor. P value \<0.05 was considered significant.|Wilcoxon (Mann-Whitney)|||||||>0.2
72590775|NCT03369067|144713399|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with the treatment mode and age group as fixed factors. P value \<0.05 was considered significant.|Wilcoxon (Mann-Whitney)|||||||>0.2
72590776|NCT03369067|144713400|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||>0.2
72590777|NCT03369067|144713400|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with age group as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||>0.2
72590778|NCT03369067|144713400|OTHER|||||||0.073||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode and age group as fixed factors. P value \<0.05 was considered significant.|ANOVA|||||||0.073
72590779|NCT03369067|144713401|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||>0.2
72590780|NCT03369067|144713401|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with age group as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||>0.2
72590781|NCT03369067|144713401|OTHER|||||||0.064||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode and age group as fixed factors. P value \<0.05 was considered significant.|ANOVA|||||||0.064
72590782|NCT03369067|144713402|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||>0.2
72590783|NCT03369067|144713402|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with age group as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||>0.2
72590784|NCT03369067|144713402|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode and age group as fixed factors. P value \<0.05 was considered significant.|ANOVA|||||||>0.2
72590785|NCT03369067|144713403|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||>0.2
72590786|NCT03369067|144713403|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with age group as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||>0.2
72590787|NCT03369067|144713403|OTHER|||||||0.104||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode and age group as fixed factors. P value \<0.05 was considered significant.|ANOVA|||||||0.104
72590788|NCT03369067|144713404|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||>0.2
72590789|NCT03369067|144713404|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with age group as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||>0.2
72590790|NCT03369067|144713404|OTHER|||||||0.198||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode and age group as fixed factors. P value \<0.05 was considered significant.|ANOVA|||||||0.198
72590791|NCT03369067|144713405|OTHER|||||||0.105||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||0.105
72590792|NCT03369067|144713405|OTHER|||||||0.001||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with age group as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||0.001
72590793|NCT03369067|144713405|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode and age group as fixed factors. P value \<0.05 was considered significant.|ANOVA|||||||>0.2
72414335|NCT04537923|144337826|SUPERIORITY||LS Mean Difference|2.3|||<|0.001|TWO_SIDED|95.0|1.2|3.3|||ANCOVA|||||3.3|1.2|<0.001
72414336|NCT04537923|144337826|SUPERIORITY||LS Mean Difference|2.2|||<|0.001|TWO_SIDED|95.0|1.2|3.3|||ANCOVA|||||3.3|1.2|<0.001
72414337|NCT04537923|144337827|SUPERIORITY||LS Mean Difference|1.6||||0.02|TWO_SIDED|95.0|0.3|2.9|||ANCOVA|||||2.9|0.3|0.020
72590794|NCT03369067|144713406|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||>0.2
72590795|NCT03369067|144713406|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with age group as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||>0.2
72590796|NCT03369067|144713406|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode and age group as fixed factors. P value \<0.05 was considered significant.|ANOVA|||||||>0.2
72590797|NCT00459706|144713447|NON_INFERIORITY_OR_EQUIVALENCE|"The non-inferiority test was performed using the 95 percent (%) two-sided confidence interval (CI) of the difference (AI minus PFS) of mean subject satisfactions (α = 2.5%).~Non-inferiority was demonstrated if the lower limit of the two-sided 95% CI \> -1."|Mean Difference (Net)|1.11|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|0.71|1.5|||ANOVA|ANOVA=analysis of variance||Non-inferiority of autoinjector (AI) over prefilled syringe (PFS) was assessed on the primary endpoint. Hypothesis tested was H0: AI minus PFS less than or equal to (≤) -1. The alternate hypothesis was H1: AI minus PFS greater than (\>) -1.||1.50|0.71|<0.001
72590798|NCT00459706|144713448|NON_INFERIORITY_OR_EQUIVALENCE|"The non-inferiority test was performed using the 95% two-sided CI of the difference (AI minus PFS) of mean subject satisfactions (α = 2.5%).~Non-inferiority was demonstrated if the lower limit of the two-sided 95% CI \> -1."|Mean Difference (Net)|1.25|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|0.85|1.64|||ANOVA|||"Non-inferiority of AI over PFS was assessed on the primary endpoint. The hypotheses tested was as follows:~H0: AI - PFS ≤ -1 H1: AI - PFS \> -1"||1.64|0.85|<0.001
72590799|NCT00459706|144713449|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.73||||0.058|TWO_SIDED|95.0|0.98|3.05|||GEE Model+Logit Link+Binomial Distributn|GEE=Generalized estimating equation Distribn=distribution||||3.05|0.98|0.058
72590800|NCT00459706|144713450|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.96||||0.019|TWO_SIDED|95.0|1.12|3.43|||GEE Model+Logit Link+Binomial Distributn|||||3.43|1.12|0.019
72590801|NCT00459706|144713451|SUPERIORITY_OR_OTHER||Regression coefficient|0.11||||0.16|TWO_SIDED|95.0|-0.04|0.27|||Regression, Linear|||All categories||0.27|-0.04|0.160
72590802|NCT00459706|144713452|SUPERIORITY_OR_OTHER||Regression coefficients|-0.75||||0.001|TWO_SIDED|95.0|-1.2|-0.29|||Regression, Linear|||Female versus male (reference).||-0.29|-1.20|0.001
72590803|NCT00459706|144713453|SUPERIORITY_OR_OTHER||Regression coefficient|-0.18||||0.676|TWO_SIDED|95.0|-0.62|0.26|||Regression, Linear|||Participants at High School/Baccalaureate Level versus participants with only Reading/Writing Capacity (reference).||0.26|-0.62|0.676
72590804|NCT00459706|144713453|SUPERIORITY_OR_OTHER||Regression coefficient|0.0||||0.676|TWO_SIDED|95.0|-0.59|0.6|||Regression, Linear|||Participants at University Level versus participants with only Reading/Writing Capacity (reference).||0.60|-0.59|0.676
72590805|NCT00459706|144713454|SUPERIORITY_OR_OTHER||Regression coefficient|-0.28||||0.02|TWO_SIDED|95.0|-0.52|-0.05|||Regression, Linear|||All categories||-0.05|-0.52|0.020
72590806|NCT00459706|144713455|SUPERIORITY_OR_OTHER||Regression coefficient|-0.35||||0.008|TWO_SIDED|95.0|-0.61|-0.09|||Regression, Linear|||All categories||-0.09|-0.61|0.008
72590807|NCT00459706|144713456|SUPERIORITY_OR_OTHER||Regression coefficient|0.17||||0.03|TWO_SIDED|95.0|0.02|0.32|||Regression, Linear|||All categories||0.32|0.02|0.030
72414338|NCT04537923|144337827|SUPERIORITY||LS Mean Difference|2.8|||<|0.001|TWO_SIDED|95.0|1.5|4.2|||ANCOVA|||||4.2|1.5|<0.001
72414339|NCT04537923|144337827|SUPERIORITY||LS Mean Difference|2.1||||0.004|TWO_SIDED|95.0|0.7|3.5|||ANCOVA|||||3.5|0.7|0.004
72414340|NCT01261611|144337828|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANCOVA|An ANCOVA on the change from baseline, baseline TWSTRS Total score, baseline BTX status and pooled centre as explanatory variables was performed.||A pre-specified analysis of the LS mean difference between the Dysport NG and Placebo arms was performed. A total of 210 subjects were included in the analysis.||||<0.0001
72414341|NCT01261611|144337828|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANCOVA|An ANCOVA on the change from baseline, baseline TWSTRS Total score, baseline BTX status and pooled centre as explanatory variables was performed.||A pre-specified analysis of the LS mean difference between the Dysport and Placebo arms was performed. A total of 213 subjects were included in the analysis.||||<0.0001
72414342|NCT01261611|144337828|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|An ANCOVA on the change from baseline with treatment, baseline TWSTRS Total score, BTX status at baseline and pooled centre as explanatory variables had been performed. The non-inferiority margin was 3 points.|LS mean difference|1.532|||||TWO_SIDED|95.0|-0.819|3.883||||||A pre-specified analysis of the LS mean difference between the Dysport NG and Dysport arms was performed. A total of 315 subjects were included in the analysis.||3.883|-0.819|
72414343|NCT04745169|144337868|SUPERIORITY|||||||0.73|||||||Wilcoxon (Mann-Whitney)|||||||0.73
72590808|NCT00459706|144713457|SUPERIORITY_OR_OTHER||Regression coefficient|-0.6||||0.006|TWO_SIDED|95.0|-1.03|-0.18|||Regression, Linear|||Self-injection Experience versus No Self-injection Experience (reference).||-0.18|-1.03|0.006
72590809|NCT00459706|144713458|SUPERIORITY_OR_OTHER||Regression coefficient|0.06||||0.278|TWO_SIDED|95.0|-0.05|0.18|||Regression, Linear|||All categories||0.18|-0.05|0.278
72590810|NCT00459706|144713459|SUPERIORITY_OR_OTHER||Regression coefficient|0.03||||0.749|TWO_SIDED|95.0|-0.15|0.21|||Regression, Linear|||All categories||0.21|-0.15|0.749
72590811|NCT00459706|144713460|SUPERIORITY_OR_OTHER||Regression coefficient|-0.08||||0.105|TWO_SIDED|95.0|-0.18|0.02|||Regression, Linear|||All categories||0.02|-0.18|0.105
72590812|NCT00459706|144713461|SUPERIORITY_OR_OTHER||Regression coefficient|0.01||||0.819|TWO_SIDED|95.0|-0.1|0.12|||Regression, Linear|||All categories||0.12|-0.10|0.819
72590813|NCT00459706|144713462|SUPERIORITY_OR_OTHER||Regression coefficient|-0.39||||0.012|TWO_SIDED|95.0|-0.69|-0.09|||Regression, Linear|||All categories, by 1-unit increments.||-0.09|-0.69|0.012
72590814|NCT00459706|144713463|SUPERIORITY_OR_OTHER||Regression coefficient|-0.1||||0.541|TWO_SIDED|95.0|-0.52|0.32|||Regression, Linear|||2 DMARDs versus 1 DMARD (reference).||0.32|-0.52|0.541
72590815|NCT00459706|144713463|SUPERIORITY_OR_OTHER||Regression coefficient|-0.14||||0.541|TWO_SIDED|95.0|-0.97|0.68|||Regression, Linear|||3 DMARDs versus 1 DMARD (reference).||0.68|-0.97|0.541
72590816|NCT00459706|144713463|SUPERIORITY_OR_OTHER||Regression coefficient|1.72||||0.541|TWO_SIDED|95.0|-0.82|4.25|||Regression, Linear|||At least 4 DMARDs versus 1 DMARD (reference).||4.25|-0.82|0.541
72590817|NCT00459706|144713464|SUPERIORITY_OR_OTHER||Regression coefficient|-0.15||||0.465|TWO_SIDED|95.0|-0.55|0.25|||Regression, Linear|||Prior Injection Experience versus No Prior Injection Experience (reference)||0.25|-0.55|0.465
72590818|NCT00459706|144713465|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.41|STANDARD_ERROR_OF_MEAN|0.29||0.154|TWO_SIDED|95.0|-0.97|0.15|||ANOVA|||||0.15|-0.97|0.154
72590819|NCT00459706|144713466|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.22|STANDARD_ERROR_OF_MEAN|0.17||0.212|TWO_SIDED|95.0|-0.12|0.56|||ANOVA|||||0.56|-0.12|0.212
72590820|NCT00459706|144713467|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.01|STANDARD_ERROR_OF_MEAN|0.19||0.965|TWO_SIDED|95.0|-0.39|0.37|||ANOVA|||||0.37|-0.39|0.965
72590821|NCT00459706|144713468|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.12|STANDARD_ERROR_OF_MEAN|0.19||0.519|TWO_SIDED|95.0|-0.25|0.5|||ANOVA|||||0.50|-0.25|0.519
72590822|NCT00459706|144713469|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.85|||<|0.001|TWO_SIDED|95.0|1.33|2.57|||GEE model+logit link+multinomial distrib|||Day 84||2.57|1.33|<0.001
72590823|NCT00459706|144713470|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.61||||0.007|TWO_SIDED|95.0|1.14|2.29|||GEE model+logit link+multinomial distrib|||||2.29|1.14|0.007
72590824|NCT00459706|144713471|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.92||||0.002|TWO_SIDED|95.0|1.26|2.92|||GEE model+logit link+multinomial distrib|||||2.92|1.26|0.002
72590825|NCT00459706|144713472|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.39|||<|0.001|TWO_SIDED|95.0|1.65|3.46|||GEE model+logit link+multinomial distrib|||||3.46|1.65|<0.001
72590826|NCT00459706|144713473|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.06|||<|0.001|TWO_SIDED|95.0|1.5|2.83|||GEE model+logit link+multinomial distrib|||||2.83|1.50|<0.001
72590827|NCT00459706|144713474|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.0|||<|0.001|TWO_SIDED|95.0|1.44|2.78|||GEE model+logit link+multinomial distrib|||||2.78|1.44|<0.001
72590828|NCT00459706|144713475|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.25||||0.184|TWO_SIDED|95.0|0.9|1.72|||GEE model+logit link+multinomial distrib|||||1.72|0.90|0.184
72590829|NCT00459706|144713476|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.32||||0.106|TWO_SIDED|95.0|0.94|1.85|||GEE model+logit link+multinomial distrib|||||1.85|0.94|0.106
72590830|NCT00459706|144713477|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.35||||0.112|TWO_SIDED|95.0|0.93|1.96|||GEE model+logit link+multinomial distrib|||||1.96|0.93|0.112
72590831|NCT00459706|144713478|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.65||||0.002|TWO_SIDED|95.0|1.21|2.24|||GEE model+logit link+multinomial distrib|||||2.24|1.21|0.002
72590832|NCT00459706|144713479|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.57|||<|0.001|TWO_SIDED|95.0|0.41|0.78|||GEE model+logit link+multinomial distrib|||||0.78|0.41|<0.001
72590833|NCT00459706|144713480|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.67||||0.022|TWO_SIDED|95.0|0.47|0.94|||GEE model+logit link+multinomial distrib|||||0.94|0.47|0.022
72590834|NCT00459706|144713481|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.64||||0.009|TWO_SIDED|95.0|0.46|0.89|||GEE model+logit link+multinomial distrib|||||0.89|0.46|0.009
72590835|NCT00459706|144713482|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.63||||0.007|TWO_SIDED|95.0|0.45|0.88|||GEE model+logit link+multinomial distrib|||||0.88|0.45|0.007
72590836|NCT00459706|144713483|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.66||||0.014|TWO_SIDED|95.0|0.47|0.92|||GEE model+logit link+multinomial distrib|||||0.92|0.47|0.014
72590837|NCT00459706|144713484|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.1|||<|0.001|TWO_SIDED|95.0|1.53|2.88|||GEE model+logit link+multinomial distrib|||||2.88|1.53|<0.001
72590838|NCT00459706|144713485|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.14|||<|0.001|TWO_SIDED|95.0|1.57|2.91|||GEE model+logit link+multinomial distrib|||||2.91|1.57|<0.001
72369833|NCT01396447|144250130|SUPERIORITY||Mean Difference (Final Values)|-0.3||||0.0489|TWO_SIDED|95.0|-0.5|0.0|||Repeated measures mixed-effects model||Cariprazine 3.0 mg vs Placebo|The analysis included treatment group, pooled study center, visit, and treatment-group-by-visit interaction as fixed effects and the baseline value and baseline value-by-visit interaction as covariates.||-0.0|-0.5|0.0489
72590839|NCT00459706|144713486|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.08|||<|0.001|TWO_SIDED|95.0|2.23|4.25|||GEE model+logit link+multinomial distrib|||||4.25|2.23|<0.001
72590840|NCT00459706|144713487|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.88|||<|0.001|TWO_SIDED|95.0|1.35|2.62|||GEE model+logit link+multinomial distrib|||||2.62|1.35|<0.001
72590841|NCT00459706|144713488|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.25|||<|0.001|TWO_SIDED|95.0|0.18|0.34|||GEE model+logit link+multinomial distrib|||||0.34|0.18|<0.001
72590842|NCT00459706|144713489|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.26|||<|0.001|TWO_SIDED|95.0|0.19|0.36|||GEE model+logit link+multinomial distrib|||||0.36|0.19|<0.001
72590843|NCT00459706|144713490|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.27|||<|0.001|TWO_SIDED|95.0|0.2|0.36|||GEE model+logit link+multinomial distrib|||||0.36|0.20|<0.001
72590844|NCT00459706|144713491|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.82||||0.196|TWO_SIDED|95.0|0.61|1.11|||GEE model+logit link+multinomial distrib|||||1.11|0.61|0.196
72590845|NCT00459706|144713492|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.74||||0.001|TWO_SIDED|95.0|1.25|2.42|||GEE model+logit link+multinomial distrib|||||2.42|1.25|0.001
72590846|NCT00459706|144713493|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.3|||<|0.001|TWO_SIDED|95.0|0.21|0.42|||GEE model+logit link+multinomial distrib|||||0.42|0.21|<0.001
72590847|NCT00459706|144713494|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.4|||<|0.001|TWO_SIDED|95.0|0.29|0.56|||GEE model+logit link+multinomial distrib|||||0.56|0.29|<0.001
72590848|NCT00459706|144713495|SUPERIORITY_OR_OTHER|||||||0.896|TWO_SIDED||||||ANOVA|||p-value for statistical difference between 3 clusters in the Autoinjector group||||0.896
72590849|NCT00459706|144713495|SUPERIORITY_OR_OTHER|||||||0.166|TWO_SIDED||||||ANOVA|||p-value for statistical difference between 3 clusters in the Prefilled Syringe group||||0.166
72590850|NCT00459706|144713496|SUPERIORITY_OR_OTHER|||||||0.069||95.0|||||Chi-squared|||p-value for statistical difference between 3 clusters in the Autoinjector group||||0.069
72590851|NCT00459706|144713496|SUPERIORITY_OR_OTHER|||||||0.015||95.0|||||Chi-squared|||p-value for statistical difference between 3 clusters in the Prefilled Syringe group||||0.015
72590852|NCT00459706|144713497|SUPERIORITY_OR_OTHER|||||||0.069||95.0|||||Chi-squared|||p-value for statistical difference between 3 clusters in the Autoinjector group||||0.069
72590853|NCT00459706|144713497|SUPERIORITY_OR_OTHER|||||||0.015||95.0|||||Chi-squared|||p-value for statistical difference between 3 clusters in the Prefilled Syringe group||||0.015
72590854|NCT00459706|144713498|SUPERIORITY_OR_OTHER|||||||0.652||95.0|||||Chi-squared|||p-value for statistical difference between 3 clusters in the Autoinjector group||||0.652
72590855|NCT00459706|144713498|SUPERIORITY_OR_OTHER|||||||0.459||95.0|||||Chi-squared|||p-value for statistical difference between 3 clusters in the Prefilled Syringe group||||0.459
72590856|NCT00459706|144713499|SUPERIORITY_OR_OTHER|||||||0.652||95.0|||||Chi-squared|||p-value for statistical difference between 3 clusters in the Autoinjector group||||0.652
72590857|NCT00459706|144713499|SUPERIORITY_OR_OTHER|||||||0.459||95.0|||||Chi-squared|||p-value for statistical difference between 3 clusters in the Prefilled Syringe group||||0.459
72590858|NCT00459706|144713500|SUPERIORITY_OR_OTHER|||||||0.652||95.0|||||Chi-squared|||p-value for statistical difference between 3 clusters in the Autoinjector group||||0.652
72590859|NCT00459706|144713500|SUPERIORITY_OR_OTHER|||||||0.459||95.0|||||Chi-squared|||p-value for statistical difference between 3 clusters in the Prefilled Syringe group||||0.459
72414344|NCT04745169|144337869|SUPERIORITY|||||||0.07|||||||Wilcoxon (Mann-Whitney)|||||||0.07
72414345|NCT04745169|144337870|SUPERIORITY|||||||0.65|||||||Wilcoxon (Mann-Whitney)|||||||0.65
72590860|NCT00459706|144713501|SUPERIORITY_OR_OTHER|||||||0.023||95.0|||||Kruskal-Wallis|||p-value for statistical difference between 3 clusters in the Autoinjector group||||0.023
72590861|NCT00459706|144713501|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Kruskal-Wallis|||p-value for statistical difference between 3 clusters in the Prefilled Syringe group||||<0.001
72590862|NCT00459706|144713502|SUPERIORITY_OR_OTHER|||||||0.038||95.0|||||Kruskal-Wallis|||p-value for statistical difference between 3 clusters in the Autoinjector group||||0.038
72590863|NCT00459706|144713502|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Kruskal-Wallis|||p-value for statistical difference between 3 clusters in the Prefilled Syringe group||||<0.001
72590864|NCT00459706|144713503|SUPERIORITY_OR_OTHER|||||||0.018||95.0|||||ANOVA|||p-value for statistical difference between 3 clusters in the Autoinjector group||||0.018
72590865|NCT00459706|144713503|SUPERIORITY_OR_OTHER|||||||0.019||95.0|||||ANOVA|||p-value for statistical difference between 3 clusters in the Prefilled Syringe group||||0.019
72590866|NCT00459706|144713504|SUPERIORITY_OR_OTHER|||||||0.049||95.0|||||Chi-squared|||p-value for statistical difference between 3 clusters in the Autoinjector group||||0.049
72590867|NCT00459706|144713504|SUPERIORITY_OR_OTHER|||||||0.736||95.0|||||Chi-squared|||p-value for statistical difference between 3 clusters in the Prefilled Syringe group||||0.736
72590868|NCT00459706|144713505|SUPERIORITY_OR_OTHER|||||||0.033||95.0|||||Chi-squared|||p-value for statistical difference between 3 clusters in the Autoinjector group||||0.033
72590869|NCT00459706|144713505|SUPERIORITY_OR_OTHER|||||||0.73||95.0|||||Chi-squared|||p-value for statistical difference between 3 clusters in the Prefilled Syringe group||||0.730
72590870|NCT00459706|144713506|SUPERIORITY_OR_OTHER|||||||0.838||95.0|||||ANOVA|||p-value for statistical difference between 3 clusters in the Autoinjector group||||0.838
72590871|NCT00459706|144713506|SUPERIORITY_OR_OTHER|||||||0.483||95.0|||||ANOVA|||p-value for statistical difference between 3 clusters in the Prefilled Syringe group||||0.483
72590872|NCT00459706|144713507|SUPERIORITY_OR_OTHER|||||||0.466||95.0|||||Kruskal-Wallis|||p-value for statistical difference between 3 clusters in the Autoinjector group||||0.466
72590873|NCT00459706|144713507|SUPERIORITY_OR_OTHER|||||||0.035||95.0|||||Kruskal-Wallis|||p-value for statistical difference between 3 clusters in the Prefilled Syringe group||||0.035
72590874|NCT00459706|144713508|SUPERIORITY_OR_OTHER|||||||0.784||95.0|||||ANOVA|||p-value for statistical difference between 3 clusters in the Autoinjector group||||0.784
72590875|NCT00459706|144713508|SUPERIORITY_OR_OTHER|||||||0.006||95.0|||||ANOVA|||p-value for statistical difference between 3 clusters in the Prefilled Syringe group||||0.006
72590876|NCT00459706|144713509|SUPERIORITY_OR_OTHER|||||||0.843||95.0|||||ANOVA|||p-value for statistical difference between 3 clusters in the Autoinjector group||||0.843
72414346|NCT04745169|144337871|SUPERIORITY|||||||0.31|||||||Wilcoxon (Mann-Whitney)|||||||0.31
72414347|NCT04745169|144337872|SUPERIORITY|||||||0.55|||||||Wilcoxon (Mann-Whitney)|||||||0.55
72414348|NCT04745169|144337873|SUPERIORITY|||||||0.95|||||||Wilcoxon (Mann-Whitney)|||||||0.95
72414349|NCT04745169|144337874|SUPERIORITY|||||||0.15|||||||Wilcoxon (Mann-Whitney)|||||||0.15
72414350|NCT04745169|144337875|SUPERIORITY|||||||0.31|||||||Wilcoxon (Mann-Whitney)|||||||0.31
72414351|NCT04745169|144337876|SUPERIORITY|||||||0.37|||||||Wilcoxon (Mann-Whitney)|||||||0.37
72590877|NCT00459706|144713509|SUPERIORITY_OR_OTHER|||||||0.461||95.0|||||ANOVA|||p-value for statistical difference between 3 clusters in the Prefilled Syringe group||||0.461
72590878|NCT00459706|144713510|SUPERIORITY_OR_OTHER|||||||0.15||95.0|||||Kruskal-Wallis|||p-value for statistical difference between 3 clusters in the Autoinjector group||||0.150
72590879|NCT00459706|144713510|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||Kruskal-Wallis|||p-value for statistical difference between 3 clusters in the Prefilled Syringe group||||0.002
72590880|NCT00459706|144713511|SUPERIORITY_OR_OTHER|||||||0.934||95.0|||||Cochran-Mantel-Haenszel|||p-value for statistical difference between 3 clusters in the Autoinjector group||||0.934
72590881|NCT00459706|144713511|SUPERIORITY_OR_OTHER|||||||0.656||95.0|||||Cochran-Mantel-Haenszel|||p-value for statistical difference between 3 clusters in the Prefilled Syringe group||||0.656
72590882|NCT00459706|144713512|SUPERIORITY_OR_OTHER|||||||0.934||95.0|||||Cochran-Mantel-Haenszel|||p-value for statistical difference between 3 clusters in the Autoinjector group||||0.934
72590883|NCT00459706|144713512|SUPERIORITY_OR_OTHER|||||||0.656||95.0|||||Cochran-Mantel-Haenszel|||p-value for statistical difference between 3 clusters in the Prefilled Syringe group||||0.656
72590884|NCT00459706|144713513|SUPERIORITY_OR_OTHER|||||||0.934||95.0|||||Cochran-Mantel-Haenszel|||p-value for statistical difference between 3 clusters in the Autoinjector group||||0.934
72590885|NCT00459706|144713513|SUPERIORITY_OR_OTHER|||||||0.656||95.0|||||Cochran-Mantel-Haenszel|||p-value for statistical difference between 3 clusters in the Prefilled Syringe group||||0.656
72590886|NCT00459706|144713514|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Kruskal-Wallis|||p-value for statistical difference between 3 clusters in the Autoinjector group||||<0.001
72590887|NCT00459706|144713514|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Kruskal-Wallis|||p-value for statistical difference between 3 clusters in the Prefilled Syringe group||||<0.001
72590888|NCT03403751|144713542|SUPERIORITY|||||||0.649|||||||Chi-squared|||||||0.649
72590889|NCT03403751|144713545|SUPERIORITY|||||||0.871|||||||Chi-squared|||||||0.871
72590890|NCT03403751|144713546|SUPERIORITY|||||||0.42|||||||Wilcoxon (Mann-Whitney)|||||||0.420
72590891|NCT03403751|144713547|SUPERIORITY|||||||0.448|||||||Wilcoxon (Mann-Whitney)|||||||0.448
72590892|NCT03403751|144713548|SUPERIORITY|||||||0.579|||||||Wilcoxon (Mann-Whitney)|||||||0.579
72590893|NCT03403751|144713549|SUPERIORITY|||||||0.227|||||||Wilcoxon (Mann-Whitney)|||||||0.227
72590894|NCT03403751|144713552|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
72590895|NCT03403751|144713553|SUPERIORITY|||||||0.002|||||||Wilcoxon (Mann-Whitney)|||||||0.002
72590896|NCT03403751|144713554|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
72414352|NCT02041195|144337888|OTHER||Least Squares (LS) Mean Difference|-4.26||||0.004|TWO_SIDED|90.0|-6.81|-1.72||One sided p-value.|Longitudinal mixed analysis of variance||A longitudinal mixed analysis of variance model with fixed effects for treatment, timepoint, treatment-by-timepoint, baseline weight as covariate, and participant as random effect was used.|||-1.72|-6.81|0.004
72414353|NCT02041195|144337888|OTHER||LS Mean difference|-3.63||||0.012|TWO_SIDED|90.0|-6.23|-1.03|||Longitudinal mixed analysis of variance|One-sided p-value.|A longitudinal mixed analysis of variance model with fixed effects for treatment, timepoint, treatment-by-timepoint, baseline weight as covariate, and participant as random effect was used.|||-1.03|-6.23|0.012
72590897|NCT03403751|144713555|SUPERIORITY|||||||0.007|||||||Wilcoxon (Mann-Whitney)|||||||0.007
72590898|NCT01820572|144713558|SUPERIORITY|difference between belatacept and CNI|Difference in proportions|0.9|||||TWO_SIDED|95.0|-8.6|10.4||||||||10.4|-8.6|
72590899|NCT01820572|144713559|SUPERIORITY|difference between belatacept and CNI|Difference in Proportions|-0.4|||||TWO_SIDED|95.0|-9.9|9.0||||||||9.0|-9.9|
72590900|NCT02091986|144713710|SUPERIORITY_OR_OTHER|||||||0.006|||||||Mixed Models Analysis|Baseline FEV1, Treatment group, Region, Age were all included as explanatory variables in the linear predictor.||||||0.006
72590901|NCT02091986|144713710|SUPERIORITY_OR_OTHER|||||||0.063|||||||Mixed Models Analysis|Baseline FEV1, Treatment group, Region, Age were all included as explanatory variables in the linear predictor.||||||0.063
72590902|NCT02091986|144713710|SUPERIORITY_OR_OTHER|||||||0.373|||||||Mixed Models Analysis|Baseline FEV1, Treatment group, Region, Age were all included as explanatory variables in the linear predictor.||||||0.373
72590903|NCT02091986|144713711|SUPERIORITY_OR_OTHER|||||||0.001|||||||Mixed Models Analysis|Baseline lung function assessment, Treatment group, Region, Age were all included as explanatory variables in the linear predictor.||||||0.001
72590904|NCT02091986|144713711|SUPERIORITY_OR_OTHER|||||||0.195|||||||Mixed Models Analysis|Baseline lung function assessment, Treatment group, Region, Age were all included as explanatory variables in the linear predictor.||||||0.195
72590905|NCT02091986|144713711|SUPERIORITY_OR_OTHER|||||||0.032|||||||Mixed Models Analysis|Baseline lung function assessment, Treatment group, Region, Age were all included as explanatory variables in the linear predictor.||||||0.032
72590906|NCT02091986|144713712|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Mixed Models Analysis|Baseline lung function assessment, Treatment group, Region, Age were all included as explanatory variables in the linear predictor.||||||<0.001
72590907|NCT02091986|144713712|SUPERIORITY_OR_OTHER|||||||0.005|||||||Mixed Models Analysis|Baseline lung function assessment, Treatment group, Region, Age were all included as explanatory variables in the linear predictor.||||||0.005
72590908|NCT02091986|144713712|SUPERIORITY_OR_OTHER|||||||0.326|||||||Mixed Models Analysis|Baseline lung function assessment, Treatment group, Region, Age were all included as explanatory variables in the linear predictor.||||||0.326
72590909|NCT02091986|144713713|SUPERIORITY_OR_OTHER|||||||0.276|||||||Mixed Models Analysis|Baseline lung function assessment, Treatment group, Region, Age were all included as explanatory variables in the linear predictor.||||||0.276
72590910|NCT02091986|144713713|SUPERIORITY_OR_OTHER|||||||0.759|||||||Mixed Models Analysis|Baseline lung function assessment, Treatment group, Region, Age were all included as explanatory variables in the linear predictor.||||||0.759
72590911|NCT02091986|144713713|SUPERIORITY_OR_OTHER|||||||0.165|||||||Mixed Models Analysis|Baseline lung function assessment, Treatment group, Region, Age were all included as explanatory variables in the linear predictor.||||||0.165
72590912|NCT02091986|144713714|SUPERIORITY_OR_OTHER|||||||0.724|||||||Mixed Models Analysis|Baseline lung function assessment, Treatment group, Region, Age were all included as explanatory variables in the linear predictor.||||||0.724
72590913|NCT02091986|144713714|SUPERIORITY_OR_OTHER|||||||0.909|||||||Mixed Models Analysis|Baseline lung function assessment, Treatment group, Region, Age were all included as explanatory variables in the linear predictor.||||||0.909
72590914|NCT02091986|144713714|SUPERIORITY_OR_OTHER|||||||0.811|||||||Mixed Models Analysis|Baseline lung function assessment, Treatment group, Region, Age were all included as explanatory variables in the linear predictor.||||||0.811
72590915|NCT02091986|144713715|SUPERIORITY_OR_OTHER|||||||0.134|||||||Mixed Models Analysis|Baseline lung function assessment, Treatment group, Region, Age were all included as explanatory variables in the linear predictor.||||||0.134
72590916|NCT02091986|144713715|SUPERIORITY_OR_OTHER|||||||0.985|||||||Mixed Models Analysis|Baseline lung function assessment, Treatment group, Region, Age were all included as explanatory variables in the linear predictor.||||||0.985
72590917|NCT02091986|144713715|SUPERIORITY_OR_OTHER|||||||0.128|||||||Mixed Models Analysis|Baseline lung function assessment, Treatment group, Region, Age were all included as explanatory variables in the linear predictor.||||||0.128
72590918|NCT02091986|144713716|SUPERIORITY_OR_OTHER|||||||0.684|||||||Mixed Models Analysis|Baseline lung function assessment, Treatment group, Region, Age were all included as explanatory variables in the linear predictor.||||||0.684
72590919|NCT02091986|144713716|SUPERIORITY_OR_OTHER|||||||0.621|||||||Mixed Models Analysis|Baseline lung function assessment, Treatment group, Region, Age were all included as explanatory variables in the linear predictor.||||||0.621
72590920|NCT02091986|144713716|SUPERIORITY_OR_OTHER|||||||0.929|||||||Mixed Models Analysis|Baseline lung function assessment, Treatment group, Region, Age were all included as explanatory variables in the linear predictor.||||||0.929
72590921|NCT02091986|144713717|SUPERIORITY_OR_OTHER|||||||0.664|||||||Mixed Models Analysis|Baseline lung function assessment, Treatment group, Region, Age were all included as explanatory variables in the linear predictor.||||||0.664
72590922|NCT02091986|144713717|SUPERIORITY_OR_OTHER|||||||0.747|||||||Mixed Models Analysis|Baseline lung function assessment, Treatment group, Region, Age were all included as explanatory variables in the linear predictor.||||||0.747
72590923|NCT02091986|144713717|SUPERIORITY_OR_OTHER|||||||0.913|||||||Mixed Models Analysis|Baseline lung function assessment, Treatment group, Region, Age were all included as explanatory variables in the linear predictor.||||||0.913
72590924|NCT02091986|144713718|SUPERIORITY_OR_OTHER|||||||0.015|||||||ANCOVA|Baseline lung function assessment, Treatment group, Region, Age were all included as explanatory variables in the linear predictor.||||||0.015
72590925|NCT02091986|144713718|SUPERIORITY_OR_OTHER|||||||0.342|||||||ANCOVA|Baseline lung function assessment, Treatment group, Region, Age were all included as explanatory variables in the linear predictor.||||||0.342
72414354|NCT02041195|144337890|OTHER||LS Mean Difference|-3.57|||<|0.001|TWO_SIDED|90.0|-5.24|-1.89||One sided p-value.|Longitudinal mixed analysis of variance||A longitudinal mixed analysis of variance model with fixed effects for treatment, timepoint, treatment-by-timepoint, baseline weight as covariate, and participant as random effect was used.|||-1.89|-5.24|<0.001
72414355|NCT02041195|144337892|OTHER||LS Mean Difference|-2.22||||0.002|TWO_SIDED|90.0|-3.44|-1.0|||Longitudinal mixed analysis of variance||A longitudinal mixed analysis of variance model with fixed effects for treatment, timepoint, treatment-by-timepoint, baseline weight as covariate, and participant as random effect was used.|||-1.00|-3.44|0.002
72590926|NCT02091986|144713718|SUPERIORITY_OR_OTHER|||||||0.138|||||||ANCOVA|Baseline lung function assessment, Treatment group, Region, Age were all included as explanatory variables in the linear predictor.||||||0.138
72590927|NCT02091986|144713722|SUPERIORITY_OR_OTHER|||||||0.098|||||||ANCOVA|The explanatory variables included in the model are: treatment group, baseline overall PAQLQ(S) score, region and age group||||||0.098
72590928|NCT02091986|144713722|SUPERIORITY_OR_OTHER|||||||0.367|||||||ANCOVA|The explanatory variables included in the model are: treatment group, baseline overall PAQLQ(S) score, region and age group||||||0.367
72590929|NCT02091986|144713722|SUPERIORITY_OR_OTHER|||||||0.449|||||||ANCOVA|The explanatory variables included in the model are: treatment group, baseline overall PAQLQ(S) score, region and age group||||||0.449
72590930|NCT02537431|144713729|OTHER||Mean|-54.18|||<|0.0001|TWO_SIDED|95.0|-68.64|-39.72||The null hypothesis of no mean percent change from baseline is tested using t-test.|t-test|||||-39.72|-68.64|< 0.0001
72590931|NCT02537431|144713730|OTHER||||||<|0.0001||||||The p-value is for testing the proportion of participants achieving the mean serum phosphorus levels above the LLN (2.5 mg/dL \[0.81 mmol/L\]) against 0% from the binomial test.|binomial test|||||||<0.0001
72590932|NCT02537431|144713731|OTHER||Mean|-32.21|||<|0.0001|TWO_SIDED|95.0|-40.25|-24.17||The null hypothesis of no mean percent change from baseline is tested using t-test.|t-test|||||-24.17|-40.25|<0.0001
72590933|NCT02537431|144713732|OTHER||Mean|-26.0||||0.0002|TWO_SIDED|95.0|-36.08|-15.91||The null hypothesis of no mean percent change from baseline is tested using t-test.|t-test|||||-15.91|-36.08|0.0002
72590934|NCT02537431|144713733|OTHER||Mean|-52.24||||0.0199|TWO_SIDED|95.0|-94.08|-10.41||The null hypothesis of no mean percent change from baseline is tested using t-test.|t-test|||||-10.41|-94.08|0.0199
72590935|NCT02537431|144713745|OTHER||Least Squares Mean (GEE)|107.75|||||TWO_SIDED|95.0|76.46|139.03|||||From the generalized estimation equation (GEE) model which includes change from baseline for 1, 25 (OH)2 D as the dependent variable, visit as fixed factors, and baseline of 1, 25 (OH)2 D as a covariate, with compound symmetry covariance structure.|Week 1||139.03|76.46|
72590936|NCT02537431|144713745|OTHER||LS Mean|48.41|||||TWO_SIDED|95.0|33.91|62.91|||||From the GEE model which includes the change from baseline for 1, 25 (OH)2 D as the dependent variable, visit as fixed factors, and baseline of 1, 25 (OH)2 D as a covariate, with compound symmetry covariance structure.|Week 2||62.91|33.91|
72590937|NCT02537431|144713745|OTHER||LS Mean|13.58|||||TWO_SIDED|95.0|6.85|20.31|||||From the GEE model which includes the change from baseline for 1, 25 (OH)2 D as the dependent variable, visit as fixed factors, and baseline of 1, 25 (OH)2 D as a covariate, with compound symmetry covariance structure.|Week 4||20.31|6.85|
72590938|NCT02537431|144713745|OTHER||LS Mean|-1.34|||||TWO_SIDED|95.0|-8.43|5.75|||||From the GEE model which includes the change from baseline for 1, 25 (OH)2 D as the dependent variable, visit as fixed factors, and baseline of 1, 25 (OH)2 D as a covariate, with compound symmetry covariance structure.|Week 20||5.75|-8.43|
72590939|NCT02537431|144713745|OTHER||LS Mean|31.75|||||TWO_SIDED|95.0|21.49|42.0|||||From the GEE model which includes the change from baseline for 1, 25 (OH)2 D as the dependent variable, visit as fixed factors, and baseline of 1, 25 (OH)2 D as a covariate, with compound symmetry covariance structure.|Week 21||42.00|21.49|
72590940|NCT02537431|144713745|OTHER||LS Mean|11.5|||||TWO_SIDED|95.0|3.54|19.46|||||From the GEE model which includes the change from baseline for 1, 25 (OH)2 D as the dependent variable, visit as fixed factors, and baseline of 1, 25 (OH)2 D as a covariate, with compound symmetry covariance structure.|Week 22||19.46|3.54|
72590941|NCT02537431|144713745|OTHER||LS Mean|-3.04|||||TWO_SIDED|95.0|-12.62|6.55|||||From the GEE model which includes the change from baseline for 1, 25 (OH)2 D as the dependent variable, visit as fixed factors, and baseline of 1, 25 (OH)2 D as a covariate, with compound symmetry covariance structure.|Week 24||6.55|-12.62|
72590942|NCT02537431|144713745|OTHER||LS Mean|-1.72||||0.6821|TWO_SIDED|95.0|-9.93|6.5|||GEE model||From the GEE model which includes the change from baseline for 1, 25 (OH)2 D as the dependent variable, visit as fixed factors, and baseline of 1, 25 (OH)2 D as a covariate, with compound symmetry covariance structure.|Week 48||6.50|-9.93|0.6821
72590943|NCT02537431|144713745|OTHER||LS mean|-5.73|||||TWO_SIDED|95.0|-12.38|0.92|||||From the GEE model which includes the change from baseline for 1, 25 (OH)2 D as the dependent variable, visit as fixed factors, and baseline of 1, 25 (OH)2 D as a covariate, with compound symmetry covariance structure.|Week 60||0.92|-12.38|
72590944|NCT02537431|144713745|OTHER||LS mean|3.36|||||TWO_SIDED|95.0|-4.45|11.18|||||From the GEE model which includes the change from baseline for 1, 25 (OH)2 D as the dependent variable, visit as fixed factors, and baseline of 1, 25 (OH)2 D as a covariate, with compound symmetry covariance structure.|Week 70||11.18|-4.45|
72590945|NCT02537431|144713745|OTHER||LS mean|-5.55|||||TWO_SIDED|95.0|-11.22|0.13|||||From the GEE model which includes the change from baseline for 1, 25 (OH)2 D as the dependent variable, visit as fixed factors, and baseline of 1, 25 (OH)2 D as a covariate, with compound symmetry covariance structure.|Week 72||0.13|-11.22|
72590946|NCT02537431|144713745|OTHER||LS mean|-5.55|||||TWO_SIDED|95.0|-11.35|0.26|||||From the GEE model which includes the change from baseline for 1, 25 (OH)2 D as the dependent variable, visit as fixed factors, and baseline of 1, 25 (OH)2 D as a covariate, with compound symmetry covariance structure.|Week 84||0.26|-11.35|
72590947|NCT02537431|144713745|OTHER||LS mean|9.63|||||TWO_SIDED|95.0|1.33|17.94|||||From the GEE model which includes the change from baseline for 1, 25 (OH)2 D as the dependent variable, visit as fixed factors, and baseline of 1, 25 (OH)2 D as a covariate, with compound symmetry covariance structure.|Week 94||17.94|1.33|
72414356|NCT02395120|144337902|SUPERIORITY||Odds Ratio (OR)|1.6|||<|0.05|TWO_SIDED|95.0|1.21|3.08||We addressed the issue of multiple testing, both multiple comparisons and multiple sites, using a gatekeeper approach. The use of 0.05 alpha level for each test maintained a 0.05 family-wise alpha level for the six tests (three at each site).|Regression, Logistic||||The primary outcome analysis utilized generalized estimating equations (GEE) with a logit link for the binary dental care receipt outcome. The GEE analysis was conducted using dental care receipt outcomes as restorative care alone (ICDAS codes ≥3), as well as combined preventive (i.e. sealants) and restorative care (ICDAS codes ≥1). Models were fit separately to the overall data (all sites combined), the combined EC and WA sites (based on our original plan of two predominantly low-income school districts), and the BD schools alone. Each model included, as covariates, indicator variables for intervention, site (except for the model with BD alone), child grade, and caregiver demographic variables (race, education, marital status). Corresponding estimated odds ratios and 95% Confidence Intervals were computed.|3.08|1.21|<0.05
72414357|NCT00674986|144337905|SUPERIORITY_OR_OTHER||Difference|0.28|STANDARD_ERROR_OF_MEAN|0.14||0.0416|TWO_SIDED|95.0|0.01|0.54|||Fisher Exact|||||0.54|0.01|0.0416
72414358|NCT00674986|144337906|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Fisher Exact|||||||<0.0001
72590948|NCT02537431|144713745|OTHER||LS mean|-6.09|||||TWO_SIDED|95.0|-10.8|-1.38||||||Week 96||-1.38|-10.80|
72590949|NCT02537431|144713745|OTHER||LS mean|0.02|||||TWO_SIDED|95.0|-9.22|9.26|||||From the GEE model which includes the change from baseline for 1, 25 (OH)2 D as the dependent variable, visit as fixed factors, and baseline of 1, 25 (OH)2 D as a covariate, with compound symmetry covariance structure.|Week 108||9.26|-9.22|
72590950|NCT02537431|144713745|OTHER||LS mean|1.45|||||TWO_SIDED|95.0|-6.77|9.68|||||From the GEE model which includes the change from baseline for 1, 25 (OH)2 D as the dependent variable, visit as fixed factors, and baseline of 1, 25 (OH)2 D as a covariate, with compound symmetry covariance structure.|Week 120||9.68|-6.77|
72590951|NCT02537431|144713745|OTHER||LS mean|-1.69|||||TWO_SIDED|95.0|-5.6|2.21|||||From the GEE model which includes the change from baseline for 1, 25 (OH)2 D as the dependent variable, visit as fixed factors, and baseline of 1, 25 (OH)2 D as a covariate, with compound symmetry covariance structure.|Week 132||2.21|-5.60|
72590952|NCT02537431|144713746|OTHER||LS Mean|0.1|||||TWO_SIDED|95.0|-0.15|0.35|||||From the GEE model; includes change from baseline from baseline for 24-Hour urinary phosphorus as the dependent variable, visit as fixed factors, and baseline of 24-Hour urinary phosphorus as a covariate, with compound symmetry covariance structure.|Week 12||0.35|-0.15|
72590953|NCT02537431|144713746|OTHER||LS Mean|-0.04|||||TWO_SIDED|95.0|-0.19|0.11|||||From the GEE model; includes change from baseline from baseline for 24-Hour urinary phosphorus as the dependent variable, visit as fixed factors, and baseline of 24-Hour urinary phosphorus as a covariate, with compound symmetry covariance structure.|Week 24||0.11|-0.19|
72590954|NCT02537431|144713746|OTHER||LS Mean|-0.01|||||TWO_SIDED|95.0|-0.12|0.11|||||From the GEE model; includes change from baseline from baseline for 24-Hour urinary phosphorus as the dependent variable, visit as fixed factors, and baseline of 24-Hour urinary phosphorus as a covariate, with compound symmetry covariance structure.|Week 36||0.11|-0.12|
72590955|NCT02537431|144713746|OTHER||LS Mean|-0.04||||0.6021|TWO_SIDED|95.0|-0.19|0.11|||GEE model||From the GEE model; includes change from baseline from baseline for 24-Hour urinary phosphorus as the dependent variable, visit as fixed factors, and baseline of 24-Hour urinary phosphorus as a covariate, with compound symmetry covariance structure.|Week 48||0.11|-0.19|0.6021
72590956|NCT02537431|144713746|OTHER||LS mean|0.0|||||TWO_SIDED|95.0|-0.19|0.19|||||From the GEE model; includes change from baseline from baseline for 24-Hour urinary phosphorus as the dependent variable, visit as fixed factors, and baseline of 24-Hour urinary phosphorus as a covariate, with compound symmetry covariance structure.|Week 72||0.19|-0.19|
72590957|NCT02537431|144713746|OTHER||LS mean|-0.13|||||TWO_SIDED|95.0|-0.29|0.03|||||From the GEE model; includes change from baseline from baseline for 24-Hour urinary phosphorus as the dependent variable, visit as fixed factors, and baseline of 24-Hour urinary phosphorus as a covariate, with compound symmetry covariance structure.|Week 96||0.03|-0.29|
72590958|NCT02537431|144713746|OTHER||LS mean|-0.07|||||TWO_SIDED|95.0|-0.41|0.26|||||From the GEE model; includes change from baseline from baseline for 24-Hour urinary phosphorus as the dependent variable, visit as fixed factors, and baseline of 24-Hour urinary phosphorus as a covariate, with compound symmetry covariance structure.|EOS II||0.26|-0.41|
72590959|NCT02537431|144713747|OTHER||LS Mean|1.76|||||TWO_SIDED|95.0|1.49|2.03|||||From the GEE model, which includes the change from baseline for TmP/GFR as the dependent variable, visit as fixed factors, and baseline of TmP/GFR as a covariate, with compound symmetry covariance structure.|Week 2||2.03|1.49|
72590960|NCT02537431|144713747|OTHER||LS Mean|0.78|||||TWO_SIDED|95.0|0.59|0.97|||||From the GEE model, which includes the change from baseline for TmP/GFR as the dependent variable, visit as fixed factors, and baseline of TmP/GFR as a covariate, with compound symmetry covariance structure.|Week 4||0.97|0.59|
72590961|NCT02537431|144713747|OTHER||LS Mean|0.58|||||TWO_SIDED|95.0|0.34|0.82|||||From the GEE model, which includes the change from baseline for TmP/GFR as the dependent variable, visit as fixed factors, and baseline of TmP/GFR as a covariate, with compound symmetry covariance structure.|Week 12||0.82|0.34|
72414359|NCT00674986|144337907|SUPERIORITY_OR_OTHER|||||||0.2777||95.0|||||t-test, 2 sided|||||||0.2777
72414360|NCT00674986|144337908|SUPERIORITY_OR_OTHER|||||||0.116||95.0|||||t-test, 2 sided|||||||0.1160
72590962|NCT02537431|144713747|OTHER||LS Mean|0.87|||||TWO_SIDED|95.0|0.74|0.99|||||From the GEE model, which includes the change from baseline for TmP/GFR as the dependent variable, visit as fixed factors, and baseline of TmP/GFR as a covariate, with compound symmetry covariance structure.|Week 22||0.99|0.74|
72414361|NCT00674986|144337909|SUPERIORITY_OR_OTHER|||||||0.1146||95.0|||||t-test, 2 sided|||||||0.1146
72414362|NCT00674986|144337910|SUPERIORITY_OR_OTHER|||||||0.047||95.0|||||t-test, 2 sided|||||||0.0470
72414363|NCT00674986|144337911|SUPERIORITY_OR_OTHER|||||||0.0003||95.0|||||t-test, 2 sided|||||||0.0003
72414364|NCT01461668|144337913|SUPERIORITY||Odds Ratio (OR)|0.41||||0.32|TWO_SIDED|95.0|0.08|1.86|||Fisher Exact||Confidence interval for the odds ratio is based upon the inversion Fisher's exact test|||1.86|0.08|0.320
72414365|NCT01024569|144337919|SUPERIORITY||MIXREG Estimate|-1.16|STANDARD_ERROR_OF_MEAN|-2.21||0.027|TWO_SIDED||||||Mixed Effects Random Regression|||||||0.027
72590963|NCT02537431|144713747|OTHER||LS Mean|0.44|||||TWO_SIDED|95.0|0.24|0.64|||||From the GEE model, which includes the change from baseline for TmP/GFR as the dependent variable, visit as fixed factors, and baseline of TmP/GFR as a covariate, with compound symmetry covariance structure.|Week 24||0.64|0.24|
72590964|NCT02537431|144713747|OTHER||LS Mean|0.2||||0.043|TWO_SIDED|95.0|0.01|0.38|||GEE model||From the GEE model, which includes the change from baseline for TmP/GFR as the dependent variable, visit as fixed factors, and baseline of TmP/GFR as a covariate, with compound symmetry covariance structure.|Week 48||0.38|0.01|0.0430
72590965|NCT02537431|144713747|OTHER||LS mean|0.3|||||TWO_SIDED|95.0|-0.04|0.64|||||From the GEE model, which includes the change from baseline for TmP/GFR as the dependent variable, visit as fixed factors, and baseline of TmP/GFR as a covariate, with compound symmetry covariance structure.|Week 60||0.64|-0.04|
72590966|NCT02537431|144713747|OTHER||LS mean|0.28|||||TWO_SIDED|95.0|0.03|0.52|||||From the GEE model, which includes the change from baseline for TmP/GFR as the dependent variable, visit as fixed factors, and baseline of TmP/GFR as a covariate, with compound symmetry covariance structure.|Week 72||0.52|0.03|
72590967|NCT02537431|144713747|OTHER||LS mean|0.39|||||TWO_SIDED|95.0|0.13|0.66|||||From the GEE model, which includes the change from baseline for TmP/GFR as the dependent variable, visit as fixed factors, and baseline of TmP/GFR as a covariate, with compound symmetry covariance structure.|Week 84||0.66|0.13|
72590968|NCT02537431|144713747|OTHER||LS mean|0.29|||||TWO_SIDED|95.0|0.1|0.48|||||From the GEE model, which includes the change from baseline for TmP/GFR as the dependent variable, visit as fixed factors, and baseline of TmP/GFR as a covariate, with compound symmetry covariance structure.|Week 96||0.48|0.10|
72590969|NCT02537431|144713747|OTHER||LS mean|0.21|||||TWO_SIDED|95.0|0.08|0.34|||||From the GEE model, which includes the change from baseline for TmP/GFR as the dependent variable, visit as fixed factors, and baseline of TmP/GFR as a covariate, with compound symmetry covariance structure.|EOSII||0.34|0.08|
72590970|NCT02537431|144713748|OTHER||LS Mean|0.07|||||TWO_SIDED|95.0|0.06|0.08|||||From the GEE model, which includes the change from baseline or percent change from baseline for TRP as the dependent variable, visit as fixed factors, and baseline of TRP as a covariate, with compound symmetry covariance structure.|Week 2||0.08|0.06|
72590971|NCT02537431|144713748|OTHER||LS Mean|0.03|||||TWO_SIDED|95.0|0.01|0.06|||||From the GEE model which includes the change from baseline or percent change from baseline for TRP as the dependent variable, visit as fixed factors, and baseline of TRP as a covariate, with compound symmetry covariance structure.|Week 4||0.06|0.01|
72590972|NCT02537431|144713748|OTHER||LS Mean|0.01|||||TWO_SIDED|95.0|-0.01|0.04|||||From the GEE model which includes the change from baseline or percent change from baseline for TRP as the dependent variable, visit as fixed factors, and baseline of TRP as a covariate, with compound symmetry covariance structure.|Week 12||0.04|-0.01|
72590973|NCT02537431|144713748|OTHER||LS Mean|0.04|||||TWO_SIDED|95.0|0.02|0.05|||||From the GEE model which includes the change from baseline or percent change from baseline for TRP as the dependent variable, visit as fixed factors, and baseline of TRP as a covariate, with compound symmetry covariance structure.|Week 22||0.05|0.02|
72590974|NCT02537431|144713748|OTHER||LS Mean|0.01|||||TWO_SIDED|95.0|-0.02|0.04||||||Week 24||0.04|-0.02|
72590975|NCT02537431|144713748|OTHER||LS Mean|0.0||||0.8377|TWO_SIDED|95.0|-0.05|0.04|||GEE model||From the GEE model which includes the change from baseline or percent change from baseline for TRP as the dependent variable, visit as fixed factors, and baseline of TRP as a covariate, with compound symmetry covariance structure.|Week 48||0.04|-0.05|0.8377
72590976|NCT02537431|144713748|OTHER||LS mean|0.03|||||TWO_SIDED|95.0|0.0|0.06|||||From the GEE model which includes the change from baseline or percent change from baseline for TRP as the dependent variable, visit as fixed factors, and baseline of TRP as a covariate, with compound symmetry covariance structure.|Week 60||0.06|-0.00|
72590977|NCT02537431|144713748|OTHER||LS mean|-0.02|||||TWO_SIDED|95.0|-0.09|0.05|||||From the GEE model which includes the change from baseline or percent change from baseline for TRP as the dependent variable, visit as fixed factors, and baseline of TRP as a covariate, with compound symmetry covariance structure.|Week 72||0.05|-0.09|
72590978|NCT02537431|144713748|OTHER||LS mean|0.02|||||TWO_SIDED|95.0|-0.01|0.06|||||From the GEE model which includes the change from baseline or percent change from baseline for TRP as the dependent variable, visit as fixed factors, and baseline of TRP as a covariate, with compound symmetry covariance structure.|Week 84||0.06|-0.01|
72590979|NCT02537431|144713748|OTHER||LS mean|0.02|||||TWO_SIDED|95.0|-0.01|0.05|||||From the GEE model which includes the change from baseline or percent change from baseline for TRP as the dependent variable, visit as fixed factors, and baseline of TRP as a covariate, with compound symmetry covariance structure.|Week 96||0.05|-0.01|
72590980|NCT02537431|144713748|OTHER||LS mean|0.01|||||TWO_SIDED|95.0|-0.01|0.03|||||From the GEE model which includes the change from baseline or percent change from baseline for TRP as the dependent variable, visit as fixed factors, and baseline of TRP as a covariate, with compound symmetry covariance structure.|EOSII||0.03|-0.01|
72414366|NCT01024569|144337920|SUPERIORITY||MIXREG Estimate|0.4|STANDARD_ERROR_OF_MEAN|2.37||0.02|TWO_SIDED||||||Mixed Effects Random Regression|||Mixed Effects Random Regression analysis was used to assess the effects of study condition on Hope outcomes.||||0.020
72590981|NCT02537431|144713749|OTHER||LS Mean|99.18|||||TWO_SIDED|95.0|76.83|121.53|||||From the GEE model, which includes the change from baseline for P1NP as the dependent variable, visit as fixed factors, and baseline of P1NP as a covariate, with compound symmetry covariance structure.|Week 12||121.53|76.83|
72590982|NCT02537431|144713749|OTHER||LS Mean|104.33|||||TWO_SIDED|95.0|82.47|126.19|||||From the GEE model, which includes the change from baseline for P1NP as the dependent variable, visit as fixed factors, and baseline of P1NP as a covariate, with compound symmetry covariance structure.|Week 24||126.19|82.47|
72590983|NCT02537431|144713749|OTHER||LS Mean|52.49|||<|0.0001|TWO_SIDED|95.0|29.84|75.13|||GEE model||From the GEE model, which includes the change from baseline for P1NP as the dependent variable, visit as fixed factors, and baseline of P1NP as a covariate, with compound symmetry covariance structure.|Week 48||75.13|29.84|< 0.0001
72590984|NCT02537431|144713749|OTHER||LS mean|37.29|||||TWO_SIDED|95.0|13.19|61.38|||||From the GEE model, which includes the change from baseline for P1NP as the dependent variable, visit as fixed factors, and baseline of P1NP as a covariate, with compound symmetry covariance structure.|Week 72||61.38|13.19|
72590985|NCT02537431|144713749|OTHER||LS mean|29.29|||||TWO_SIDED|95.0|3.18|55.4|||||From the GEE model, which includes the change from baseline for P1NP as the dependent variable, visit as fixed factors, and baseline of P1NP as a covariate, with compound symmetry covariance structure.|Week 96||55.40|3.18|
72590986|NCT02537431|144713749|OTHER||LS mean|2.14|||||TWO_SIDED|95.0|-17.67|21.94|||||From the GEE model, which includes the change from baseline for P1NP as the dependent variable, visit as fixed factors, and baseline of P1NP as a covariate, with compound symmetry covariance structure.|EOSII||21.94|-17.67|
72590987|NCT02537431|144713750|OTHER||LS Mean|133.08|||||TWO_SIDED|95.0|106.26|159.89|||||From the GEE model, which includes the percent change from baseline for P1NP as the dependent variable, visit as fixed factors, and baseline of P1NP as a covariate, with compound symmetry covariance structure.|Week 12||159.89|106.26|
72590988|NCT02537431|144713750|OTHER||LS Mean|137.8|||||TWO_SIDED|95.0|106.95|168.65|||||From the GEE model, which includes the percent change from baseline for P1NP as the dependent variable, visit as fixed factors, and baseline of P1NP as a covariate, with compound symmetry covariance structure.|Week 24||168.65|106.95|
72590989|NCT02537431|144713750|OTHER||LS Mean|76.86|||<|0.0001|TWO_SIDED|95.0|49.2|104.53|||GEE model||From the GEE model, which includes the percent change from baseline for P1NP as the dependent variable, visit as fixed factors, and baseline of P1NP as a covariate, with compound symmetry covariance structure.|Week 48||104.53|49.20|< 0.0001
72590990|NCT02537431|144713750|OTHER||LS mean|50.46|||||TWO_SIDED|95.0|23.69|77.23|||||From the GEE model, which includes the percent change from baseline for P1NP as the dependent variable, visit as fixed factors, and baseline of P1NP as a covariate, with compound symmetry covariance structure.|Week 72||77.23|23.69|
72590991|NCT02537431|144713750|OTHER||LS mean|41.36|||||TWO_SIDED|95.0|18.69|64.03|||||From the GEE model, which includes the percent change from baseline for P1NP as the dependent variable, visit as fixed factors, and baseline of P1NP as a covariate, with compound symmetry covariance structure.|Week 96||64.03|18.69|
72590992|NCT02537431|144713750|OTHER||LS mean|26.2|||||TWO_SIDED|95.0|6.76|45.64|||||From the GEE model, which includes the percent change from baseline for P1NP as the dependent variable, visit as fixed factors, and baseline of P1NP as a covariate, with compound symmetry covariance structure.|EOSII||45.64|6.76|
72590993|NCT02537431|144713751|OTHER||LS Mean|464.84|||||TWO_SIDED|95.0|343.92|585.77|||||From the GEE model which includes the change from baseline for CTx as the dependent variable, visit as fixed factors, and baseline of CTx as a covariate, with compound symmetry covariance structure.|Week 12||585.77|343.92|
72590994|NCT02537431|144713751|OTHER||LS Mean|404.13|||||TWO_SIDED|95.0|294.47|513.78|||||From the GEE model which includes the change from baseline for CTx as the dependent variable, visit as fixed factors, and baseline of CTx as a covariate, with compound symmetry covariance structure.|Week 24||513.78|294.47|
72590995|NCT02537431|144713751|OTHER||LS Mean|175.13|||<|0.0001|TWO_SIDED|95.0|88.85|261.41|||GEE model||From the GEE model which includes the change from baseline for CTx as the dependent variable, visit as fixed factors, and baseline of CTx as a covariate, with compound symmetry covariance structure.|Week 48||261.41|88.85|< 0.0001
72590996|NCT02537431|144713751|OTHER||LS mean|143.11|||||TWO_SIDED|95.0|-38.2|324.41|||||From the GEE model which includes the change from baseline for CTx as the dependent variable, visit as fixed factors, and baseline of CTx as a covariate, with compound symmetry covariance structure.|Week 72||324.41|-38.20|
72590997|NCT02537431|144713751|OTHER||LS mean|76.8|||||TWO_SIDED|95.0|-35.62|189.22|||||From the GEE model which includes the change from baseline for CTx as the dependent variable, visit as fixed factors, and baseline of CTx as a covariate, with compound symmetry covariance structure.|Week 96||189.22|-35.62|
72590998|NCT02537431|144713751|OTHER||LS mean|-41.32|||||TWO_SIDED|95.0|-204.28|121.64|||||From the GEE model which includes the change from baseline for CTx as the dependent variable, visit as fixed factors, and baseline of CTx as a covariate, with compound symmetry covariance structure.|EOSII||121.64|-204.28|
72414367|NCT01024569|144337921|SUPERIORITY||MIXREG Estimate|0.05|STANDARD_ERROR_OF_MEAN|0.02||0.029|TWO_SIDED||||||Mixed Effects Random Regression|||||||0.029
72590999|NCT02537431|144713752|OTHER||LS Mean|89.68|||||TWO_SIDED|95.0|63.58|115.78|||||From the GEE model which includes the percent change from baseline for CTx as the dependent variable, visit as fixed factors, and baseline of CTx as a covariate, with compound symmetry covariance structure.|Week 12||115.78|63.58|
72591000|NCT02537431|144713752|OTHER||LS Mean|70.17|||||TWO_SIDED|95.0|49.9|90.44|||||From the GEE model which includes the percent change from baseline for CTx as the dependent variable, visit as fixed factors, and baseline of CTx as a covariate, with compound symmetry covariance structure.|Week 24||90.44|49.90|
72591001|NCT02537431|144713752|OTHER||LS Mean|35.86|||<|0.0001|TWO_SIDED|95.0|21.37|50.36|||GEE model||From the GEE model which includes the percent change from baseline for CTx as the dependent variable, visit as fixed factors, and baseline of CTx as a covariate, with compound symmetry covariance structure.|Week 48||50.36|21.37|< 0.0001
72414368|NCT01024569|144337922|SUPERIORITY||MIXREG Estimate|1.06|STANDARD_ERROR_OF_MEAN|0.52||0.042|TWO_SIDED||||||Mixed Effects Random Regression|||||||0.042
72591002|NCT02537431|144713752|OTHER||LS mean|34.0|||||TWO_SIDED|95.0|6.53|61.47|||||From the GEE model which includes the percent change from baseline for CTx as the dependent variable, visit as fixed factors, and baseline of CTx as a covariate, with compound symmetry covariance structure.|Week 72||61.47|6.53|
72591003|NCT02537431|144713752|OTHER||LS mean|25.86|||||TWO_SIDED|95.0|9.27|42.44|||||From the GEE model which includes the percent change from baseline for CTx as the dependent variable, visit as fixed factors, and baseline of CTx as a covariate, with compound symmetry covariance structure.|Week 96||42.44|9.27|
72591004|NCT02537431|144713752|OTHER||LS mean|17.88|||||TWO_SIDED|95.0|-0.32|36.07|||||From the GEE model which includes the percent change from baseline for CTx as the dependent variable, visit as fixed factors, and baseline of CTx as a covariate, with compound symmetry covariance structure.|EOSII||36.07|-0.32|
72591005|NCT02537431|144713753|OTHER||LS Mean|10.93|||||TWO_SIDED|95.0|3.98|17.89|||||From the GEE model, which includes the change from baseline for Bone ALP as the dependent variable, visit as fixed factors, and baseline of Bone ALP as a covariate, with compound symmetry covariance structure.|Week 12||17.89|3.98|
72591006|NCT02537431|144713753|OTHER||LS Mean|5.82|||||TWO_SIDED|95.0|-0.02|11.66|||||From the GEE model, which includes the change from baseline for Bone ALP as the dependent variable, visit as fixed factors, and baseline of Bone ALP as a covariate, with compound symmetry covariance structure.|Week 24||11.66|-0.02|
72591007|NCT02537431|144713753|OTHER||LS Mean|4.5||||0.2592|TWO_SIDED|95.0|-3.32|12.32|||GEE model||From the GEE model, which includes the change from baseline for Bone ALP as the dependent variable, visit as fixed factors, and baseline of Bone ALP as a covariate, with compound symmetry covariance structure.|Week 48||12.32|-3.32|0.2592
72591008|NCT02537431|144713753|OTHER||LS mean|3.13|||||TWO_SIDED|95.0|-1.64|7.9|||||From the GEE model, which includes the change from baseline for Bone ALP as the dependent variable, visit as fixed factors, and baseline of Bone ALP as a covariate, with compound symmetry covariance structure.|Week 72||7.90|-1.64|
72591009|NCT02537431|144713753|OTHER||LS mean|1.14|||||TWO_SIDED|95.0|-2.84|5.11|||||From the GEE model, which includes the change from baseline for Bone ALP as the dependent variable, visit as fixed factors, and baseline of Bone ALP as a covariate, with compound symmetry covariance structure.|Week 96||5.11|-2.84|
72591010|NCT02537431|144713753|OTHER||LS mean|-5.8|||||TWO_SIDED|95.0|-12.46|0.85|||||From the GEE model, which includes the change from baseline for Bone ALP as the dependent variable, visit as fixed factors, and baseline of Bone ALP as a covariate, with compound symmetry covariance structure.|EOSII||0.85|-12.46|
72591011|NCT02537431|144713754|OTHER||LS Mean|52.54|||||TWO_SIDED|95.0|21.18|83.9|||||From the GEE model, which includes the percent change from baseline for Bone ALP as the dependent variable, visit as fixed factors, and baseline of Bone ALP as a covariate, with compound symmetry covariance structure.|Week 12||83.90|21.18|
72591012|NCT02537431|144713754|OTHER||LS Mean|31.37|||||TWO_SIDED|95.0|8.23|54.51|||||From the GEE model, which includes the percent change from baseline for Bone ALP as the dependent variable, visit as fixed factors, and baseline of Bone ALP as a covariate, with compound symmetry covariance structure.|Week 24||54.51|8.23|
72591013|NCT02537431|144713754|OTHER||l|24.35||||0.1672|TWO_SIDED|95.0|-10.2|58.9|||GEE model||From the GEE model, which includes the percent change from baseline for Bone ALP as the dependent variable, visit as fixed factors, and baseline of Bone ALP as a covariate, with compound symmetry covariance structure.|Week 48||58.90|-10.20|0.1672
72591014|NCT02537431|144713754|OTHER||LS mean|15.13|||||TWO_SIDED|95.0|-11.19|41.46|||||From the GEE model, which includes the percent change from baseline for Bone ALP as the dependent variable, visit as fixed factors, and baseline of Bone ALP as a covariate, with compound symmetry covariance structure.|Week 72||41.46|-11.19|
72591015|NCT02537431|144713754|OTHER||LS mean|6.92|||||TWO_SIDED|95.0|-13.44|27.28|||||From the GEE model, which includes the percent change from baseline for Bone ALP as the dependent variable, visit as fixed factors, and baseline of Bone ALP as a covariate, with compound symmetry covariance structure.|Week 96||27.28|-13.44|
72591016|NCT02537431|144713754|OTHER||LS mean|-27.3|||||TWO_SIDED|95.0|-52.33|-2.28|||||From the GEE model, which includes the percent change from baseline for Bone ALP as the dependent variable, visit as fixed factors, and baseline of Bone ALP as a covariate, with compound symmetry covariance structure.|EOSII||-2.28|-52.33|
72591017|NCT00794040|144713786|SUPERIORITY||Odds Ratio (OR)|11.7||||0.006|TWO_SIDED|95.0|2.0|68.16||priori threshold p\<0.05|Multilevel growth curve model|||||68.16|2.00|0.006
72591018|NCT00794040|144713787|SUPERIORITY||Mean Difference (Final Values)|-0.62||||0.085|TWO_SIDED|95.0|-1.32|0.09||priori threshold \<0.05|Multilevel growth curve model|||||0.09|-1.32|0.085
72591019|NCT00794040|144713788|SUPERIORITY||Mean Difference (Final Values)|4.72||||0.124|TWO_SIDED|95.0|-1.3|10.74||priori threshold p\<0.05|Wilcoxon (Mann-Whitney)|||||10.74|-1.30|0.124
72414369|NCT01024569|144337923|SUPERIORITY||MIXREG Estimate|0.39|STANDARD_ERROR_OF_MEAN|0.11||0.001|TWO_SIDED||||||Mixed Effects Random Regression|||||||.001
72414370|NCT01983293|144337932|SUPERIORITY|||||||0.001|ONE_SIDED|95.0|||||Fisher Exact|||||||0.001
72414371|NCT00778648|144337962|SUPERIORITY_OR_OTHER|||||||0.023||95.0|||||ANOVA|||||||0.023
72414372|NCT03750552|144337968|SUPERIORITY||Least Squares Mean Difference|-0.23|STANDARD_ERROR_OF_MEAN|0.413||0.574|TWO_SIDED|95.0|-1.05|0.58|||Mixed Model Repeated Measures|||||0.58|-1.05|0.574
72414373|NCT03750552|144337969|SUPERIORITY||Least Squares Mean Difference|-0.28|STANDARD_ERROR_OF_MEAN|0.284||0.331|TWO_SIDED|95.0|-0.84|0.28|||Mixed Model Repeated Measures|||||0.28|-0.84|0.331
72591020|NCT00794040|144713789|SUPERIORITY||Mean Difference (Final Values)|0.02||||0.993|TWO_SIDED|95.0|-4.76|4.8||priori threshold p\<0.05|Multilevel growth curve model|||||4.80|-4.76|0.993
72591021|NCT00794040|144713790|SUPERIORITY||Mean Difference (Final Values)|1.02||||0.598|TWO_SIDED|95.0|-4.23|2.19||priori threshold p\<0.05|Multilevel growth curve model|||||2.19|-4.23|0.598
72591022|NCT01340027|144713791|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|7.44||0.97|TWO_SIDED|95.0|-14.3|14.9|||ANCOVA|||"Statistical comparisons were made using 2-sided tests at the 0.05 significance level. No adjustment for multiple testing was performed.~The ANCOVA model for all pairwise comparisons includes the 2 main factors mirabegron dose and solifenacin succinate dose and their interaction, sex, age group and geographic region as fixed factors and Baseline value as a covariate.~Least squares (LS) mean differences were calculated by subtracting Solifenacin 5 mg/Placebo from the comparison treatment group."||14.9|-14.3|0.97
72591023|NCT01340027|144713791|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|3.4|STANDARD_ERROR_OF_MEAN|6.15||0.58|TWO_SIDED|95.0|-8.6|15.5|||ANCOVA|||||15.5|-8.6|0.58
72591024|NCT01340027|144713791|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|5.9|STANDARD_ERROR_OF_MEAN|6.13||0.33|TWO_SIDED|95.0|-6.1|18.0|||ANCOVA|||||18.0|-6.1|0.33
72591025|NCT01340027|144713791|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|17.6|STANDARD_ERROR_OF_MEAN|6.2||0.005|TWO_SIDED|95.0|5.4|29.8|||ANCOVA|||||29.8|5.4|0.005
72591026|NCT01340027|144713791|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|18.2|STANDARD_ERROR_OF_MEAN|6.1||0.003|TWO_SIDED|95.0|6.2|30.2|||ANCOVA|||||30.2|6.2|0.003
72591027|NCT01340027|144713791|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|21.7|STANDARD_ERROR_OF_MEAN|7.37||0.003|TWO_SIDED|95.0|7.2|36.1|||ANCOVA|||||36.1|7.2|0.003
72591028|NCT01340027|144713791|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|26.3|STANDARD_ERROR_OF_MEAN|7.32|<|0.001|TWO_SIDED|95.0|11.9|40.7|||ANCOVA|||||40.7|11.9|<0.001
72591029|NCT01340027|144713791|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|11.0|STANDARD_ERROR_OF_MEAN|8.46||0.2|TWO_SIDED|95.0|-5.6|27.6|||ANCOVA|||||27.6|-5.6|0.20
72591030|NCT01340027|144713791|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|20.5|STANDARD_ERROR_OF_MEAN|8.43||0.015|TWO_SIDED|95.0|4.0|37.1|||ANCOVA|||||37.1|4.0|0.015
72591031|NCT01340027|144713791|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|22.4|STANDARD_ERROR_OF_MEAN|8.43||0.008|TWO_SIDED|95.0|5.9|39.0|||ANCOVA|||||39.0|5.9|0.008
72591032|NCT01340027|144713791|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|22.0|STANDARD_ERROR_OF_MEAN|7.32||0.003|TWO_SIDED|95.0|7.6|36.3|||ANCOVA|||||36.3|7.6|0.003
72591033|NCT01340027|144713791|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|22.2|STANDARD_ERROR_OF_MEAN|8.46||0.009|TWO_SIDED|95.0|5.6|38.8|||ANCOVA|||||38.8|5.6|0.009
72591034|NCT01340027|144713791|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|25.4|STANDARD_ERROR_OF_MEAN|7.35|<|0.001|TWO_SIDED|95.0|11.0|39.8|||ANCOVA|||||39.8|11.0|<0.001
72591035|NCT01340027|144713791|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|27.9|STANDARD_ERROR_OF_MEAN|7.34|<|0.001|TWO_SIDED|95.0|13.5|42.3|||ANCOVA|||||42.3|13.5|<0.001
72591036|NCT01340027|144713791|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|39.6|STANDARD_ERROR_OF_MEAN|7.39|<|0.001|TWO_SIDED|95.0|25.1|54.1|||ANCOVA|||||54.1|25.1|<0.001
72591037|NCT01340027|144713791|SUPERIORITY_OR_OTHER_LEGACY||LS Mean DIfference|40.2|STANDARD_ERROR_OF_MEAN|7.31|<|0.001|TWO_SIDED|95.0|25.8|54.5|||ANCOVA|||||54.5|25.8|<0.001
72591038|NCT01340027|144713791|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|43.6|STANDARD_ERROR_OF_MEAN|8.42|<|0.001|TWO_SIDED|95.0|27.1|60.1|||ANCOVA|||||60.1|27.1|<0.001
72591039|NCT01340027|144713791|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|48.3|STANDARD_ERROR_OF_MEAN|8.35|<|0.001|TWO_SIDED|95.0|31.9|64.7|||ANCOVA|||||64.7|31.9|<0.001
72591040|NCT01340027|144713792|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.68|STANDARD_ERROR_OF_MEAN|0.366||0.062|TWO_SIDED|95.0|-1.4|0.03|||ANCOVA|||"Statistical comparisons were made using 2-sided tests at the 0.05 significance level. No adjustment for multiple testing was performed.~The ANCOVA model for all pairwise comparisons includes the 2 main factors mirabegron dose and solifenacin succinate dose and their interaction, sex, age group and geographic region as fixed factors and baseline measurement as a covariate.~LS Mean Differences were calculated by subtracting Solifenacin 5 mg/Placebo from the comparison treatment group."||0.03|-1.40|0.062
72591041|NCT01340027|144713792|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.302||0.91|TWO_SIDED|95.0|-0.63|0.56|||ANCOVA|||||0.56|-0.63|0.91
72591042|NCT01340027|144713792|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.39|STANDARD_ERROR_OF_MEAN|0.302||0.2|TWO_SIDED|95.0|-0.98|0.2|||ANCOVA|||||0.20|-0.98|0.20
72591043|NCT01340027|144713792|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.305||0.96|TWO_SIDED|95.0|-0.62|0.58|||ANCOVA|||||0.58|-0.62|0.96
72591044|NCT01340027|144713792|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.3||0.007|TWO_SIDED|95.0|-1.39|-0.22|||ANCOVA|||||-0.22|-1.39|0.007
72591045|NCT01340027|144713792|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.88|STANDARD_ERROR_OF_MEAN|0.363||0.016|TWO_SIDED|95.0|-1.59|-0.16|||ANCOVA|||||-0.16|-1.59|0.016
72591046|NCT01340027|144713792|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.98|STANDARD_ERROR_OF_MEAN|0.36||0.007|TWO_SIDED|95.0|-1.68|-0.27|||ANCOVA|||||-0.27|-1.68|0.007
72591047|NCT01340027|144713792|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.417||0.91|TWO_SIDED|95.0|-0.87|0.77|||ANCOVA|||||0.77|-0.87|0.91
72591048|NCT01340027|144713792|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.415||0.76|TWO_SIDED|95.0|-0.94|0.69|||ANCOVA|||||0.69|-0.94|0.76
72591049|NCT01340027|144713792|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.416||0.99|TWO_SIDED|95.0|-0.82|0.81|||ANCOVA|||||0.81|-0.82|0.99
72591050|NCT01340027|144713792|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.361||0.77|TWO_SIDED|95.0|-0.82|0.6|||ANCOVA|||||0.60|-0.82|0.77
72591051|NCT01340027|144713792|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.79|STANDARD_ERROR_OF_MEAN|0.417||0.058|TWO_SIDED|95.0|-1.61|0.03|||ANCOVA|||||0.03|-1.61|0.058
72591052|NCT01340027|144713792|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.362||0.69|TWO_SIDED|95.0|-0.85|0.57|||ANCOVA|||||0.57|-0.85|0.69
72591053|NCT01340027|144713792|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.362||0.17|TWO_SIDED|95.0|-1.21|0.21|||ANCOVA|||||0.21|-1.21|0.17
72591054|NCT01340027|144713792|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.364||0.73|TWO_SIDED|95.0|-0.84|0.59|||ANCOVA|||||0.59|-0.84|0.73
72591055|NCT01340027|144713792|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.91|STANDARD_ERROR_OF_MEAN|0.361||0.012|TWO_SIDED|95.0|-1.62|-0.2|||ANCOVA|||||-0.20|-1.62|0.012
72591056|NCT01340027|144713792|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.98|STANDARD_ERROR_OF_MEAN|0.414||0.018|TWO_SIDED|95.0|-1.8|-0.17|||ANCOVA|||||-0.17|-1.80|0.018
72591057|NCT01340027|144713792|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.08|STANDARD_ERROR_OF_MEAN|0.412||0.009|TWO_SIDED|95.0|-1.89|-0.28|||ANCOVA|||||-0.28|-1.89|0.009
72591058|NCT01340027|144713793|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.46||0.51|TWO_SIDED|95.0|-1.0|0.82||Statistical comparisons were made using 2-sided tests at the 0.05 significance level. No adjustment for multiple testing was performed.|Stratified Rank ANCOVA|P-values are from pairwise comparisons of the combination/active treatment groups vs. solifenacin 5 mg/placebo within a stratified rank ANCOVA model.||The ANCOVA model including the 2 main factors mirabegron dose and solifenacin dose and their interaction, sex, age group and geographic region as fixed factors and Baseline measurement as a covariate was used to calculate point estimates and 95% confidence intervals (CI) for change from Baseline within each treatment group and for differences between combination treatment groups and solifenacin 5 mg as well as for differences between active treatment groups and placebo.||0.82|-1.00|0.51
72591059|NCT01340027|144713793|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.13|STANDARD_ERROR_OF_MEAN|0.355||0.21|TWO_SIDED|95.0|-0.57|0.83|||Stratified Rank ANCOVA|||||0.83|-0.57|0.21
72591060|NCT01340027|144713793|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.03|STANDARD_ERROR_OF_MEAN|0.361||0.89|TWO_SIDED|95.0|-0.68|0.74|||Stratified Rank ANCOVA|||||0.74|-0.68|0.89
72591061|NCT01340027|144713793|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.34|STANDARD_ERROR_OF_MEAN|0.365||0.001|TWO_SIDED|95.0|-1.06|0.38||P values were calculated from a pairwise comparison of the combination treatment groups vs solifenacin succinate 5 mg or placebo within the ANCOVA model.|Stratified Rank ANCOVA|||||0.38|-1.06|0.001
72591062|NCT01340027|144713793|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.26|STANDARD_ERROR_OF_MEAN|0.397||0.058|TWO_SIDED|95.0|-1.04|0.52|||Stratified Rank ANCOVA|||||0.52|-1.04|0.058
72591063|NCT01340027|144713793|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.6|STANDARD_ERROR_OF_MEAN|0.395||0.15|TWO_SIDED|95.0|-0.17|1.38|||Stratified Rank ANCOVA|||||1.38|-0.17|0.15
72591064|NCT01340027|144713793|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.417||0.41|TWO_SIDED|95.0|-0.91|0.73|||Stratified Rank ANCOVA|||||0.73|-0.91|0.41
72591065|NCT01340027|144713793|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.21|STANDARD_ERROR_OF_MEAN|0.554||0.44|TWO_SIDED|95.0|-0.88|1.3|||Stratified Rank ANCOVA|||||1.30|-0.88|0.44
72591066|NCT01340027|144713793|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.05|STANDARD_ERROR_OF_MEAN|0.505||0.85|TWO_SIDED|95.0|-0.95|1.04|||Stratified Rank ANCOVA|||||1.04|-0.95|0.85
72591067|NCT01340027|144713793|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.31|STANDARD_ERROR_OF_MEAN|0.533||0.83|TWO_SIDED|95.0|-1.36|0.74|||Stratified Rank ANCOVA|||||0.74|-1.36|0.83
72591068|NCT01340027|144713793|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.07|STANDARD_ERROR_OF_MEAN|0.444||0.56|TWO_SIDED|95.0|-0.8|0.95|||Stratified Rank ANCOVA|||||0.95|-0.80|0.56
72591069|NCT01340027|144713793|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.534||0.48|TWO_SIDED|95.0|-1.07|1.03|||Stratified Rank ANCOVA|||||1.03|-1.07|0.48
72591070|NCT01340027|144713793|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|0.443||0.13|TWO_SIDED|95.0|-0.67|1.07|||Stratified Rank ANCOVA|||||1.07|-0.67|0.13
72591071|NCT01340027|144713793|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.448||0.62|TWO_SIDED|2.0|-0.78|0.99|||Stratified Rank ANCOVA|||||0.99|-0.78|0.62
72591072|NCT01340027|144713793|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.27|STANDARD_ERROR_OF_MEAN|0.454||0.34|TWO_SIDED|95.0|-1.16|0.63|||Stratified Rank ANCOVA|||||0.63|-1.16|0.34
72591073|NCT01340027|144713793|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.472||0.24|TWO_SIDED|95.0|-1.12|0.74|||Stratified Rank ANCOVA|||||0.74|-1.12|0.24
72591074|NCT01340027|144713793|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.68|STANDARD_ERROR_OF_MEAN|0.475||0.88|TWO_SIDED|95.0|-0.26|1.61|||Stratified Rank ANCOVA|||||1.61|-0.26|0.88
72591075|NCT01340027|144713793|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.494||0.83|TWO_SIDED|95.0|-0.99|0.95|||Stratified Rank ANCOVA|||||0.95|-0.99|0.83
72591076|NCT01340027|144713796|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.29||||0.42|TWO_SIDED|95.0|0.69|2.39|||Regression, Logistic|||"All statistical comparisons are for End of Treatment using 2-sided tests at the 0.05 significance level. No adjustment for multiple testing was performed.~The logistic regression model includes the 2 main factors mirabegron dose and solifenacin dose and their interaction, sex, age group and geographic region as fixed factors and baseline measurement as a covariate."||2.39|0.69|0.42
72591077|NCT01340027|144713796|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.2||||0.48|TWO_SIDED|95.0|0.72|2.0|||Regression, Logistic|||||2.00|0.72|0.48
72591078|NCT01340027|144713796|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.11||||0.69|TWO_SIDED|95.0|0.67|1.83|||Regression, Logistic|||||1.83|0.67|0.69
72414374|NCT03750552|144337970|SUPERIORITY||Least Squares Mean Difference|-0.27|STANDARD_ERROR_OF_MEAN|0.376||0.481|TWO_SIDED|95.0|-1.01|0.48|||Mixed Model Repeated Measures|||||0.48|-1.01|0.481
72591079|NCT01340027|144713796|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.02||||0.95|TWO_SIDED|95.0|0.61|1.69|||Regression, Logistic|||||1.69|0.61|0.95
72591080|NCT01340027|144713796|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.91||||0.015|TWO_SIDED|95.0|1.14|3.21|||Regression, Logistic|||||3.21|1.14|0.015
72591081|NCT01340027|144713796|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.06||||0.023|TWO_SIDED|95.0|1.11|3.84|||Regression, Logistic|||||3.84|1.11|0.023
72591082|NCT01340027|144713796|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.54||||0.16|TWO_SIDED|95.0|0.84|2.84|||Regression, Logistic|||||2.84|0.84|0.16
72591083|NCT01340027|144713796|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.89||||0.73|TWO_SIDED|95.0|0.45|1.76|||Regression, Logistic|||||1.76|0.45|0.73
72591084|NCT01340027|144713796|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.88||||0.7|TWO_SIDED|95.0|0.45|1.72|||Regression, Logistic|||||1.72|0.45|0.70
72591085|NCT01340027|144713796|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.49||||0.26|TWO_SIDED|95.0|0.74|2.99|||Regression, Logistic|||||2.99|0.74|0.26
72591086|NCT01340027|144713796|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.13||||0.69|TWO_SIDED|95.0|0.63|2.04|||Regression, Logistic|||||2.04|0.63|0.69
72591087|NCT01340027|144713796|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.45||||0.29|TWO_SIDED|95.0|0.73|2.89|||Regression, Logistic|||||2.89|0.73|0.29
72414375|NCT03750552|144337971|SUPERIORITY||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.073||0.74|TWO_SIDED|95.0|-0.12|0.17|||Cochran-Mantel-Haenszel|Stratified by disease type|The assumed common risk difference estimate and standard error are calculated using Mantel-Haenszel stratum weights and the Sato variance estimator. Mantel-Haenszel confidence limits are shown.|||0.17|-0.12|0.740
72414376|NCT03750552|144337972|SUPERIORITY||Mean Difference (Final Values)|0.11|STANDARD_ERROR_OF_MEAN|0.064||0.0903|TWO_SIDED|95.0|-0.02|0.24|||Cochran-Mantel-Haenszel|Stratified by disease type|The assumed common risk difference estimate and standard error are calculated using Mantel-Haenszel stratum weights and the Sato variance estimator. Mantel-Haenszel confidence limits are shown.|||0.24|-0.02|0.0903
72414377|NCT02212028|144337973|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|68.0||||0.022|TWO_SIDED|95.0|10.0|126.0|||ANOVA|||||126|10|0.022
72414378|NCT02212028|144337974|SUPERIORITY_OR_OTHER|||||||0.005|||||||ANOVA|||||||0.005
72591088|NCT01340027|144713796|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.36||||0.31|TWO_SIDED|95.0|0.75|2.45|||Regression, Logistic|||||2.45|0.75|0.31
72591089|NCT01340027|144713796|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.25||||0.45|TWO_SIDED|95.0|0.7|2.25|||Regression, Logistic|||||2.25|0.70|0.45
72591090|NCT01340027|144713796|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.15||||0.64|TWO_SIDED|95.0|0.64|2.07|||Regression, Logistic|||||2.07|0.64|0.64
72591091|NCT01340027|144713796|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.16||||0.013|TWO_SIDED|95.0|1.18|3.94|||Regression, Logistic|||||3.94|1.18|0.013
72591092|NCT01340027|144713796|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.33||||0.017|TWO_SIDED|95.0|1.16|4.66|||Regression, Logistic|||||4.66|1.16|0.017
72591093|NCT01340027|144713796|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.74||||0.11|TWO_SIDED|95.0|0.88|3.45|||Regression, Logistic|||||3.45|0.88|0.11
72591094|NCT01340027|144713798|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.64||||0.52|TWO_SIDED|95.0|0.16|2.56|||Regression, Logistic|||"All statistical comparisons are for End of Treatment using 2-sided tests at the 0.05 significance level. No adjustment for multiple testing was performed.~The logistic regression model includes the 2 main factors mirabegron dose and solifenacin dose and their interaction, sex, age group and geographic region as fixed factors and baseline measurement as a covariate."||2.56|0.16|0.52
72591095|NCT01340027|144713798|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.67||||0.48|TWO_SIDED|95.0|0.23|1.99|||Regression, Logistic|||||1.99|0.23|0.48
72591096|NCT01340027|144713798|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.95||||0.93|TWO_SIDED|95.0|0.32|2.81|||Regression, Logistic|||||2.81|0.32|0.93
72591097|NCT01340027|144713798|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|6.12||||0.013|TWO_SIDED|95.0|1.47|25.6|||Regression, Logistic|||||25.60|1.47|0.013
72591098|NCT01340027|144713798|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|5.49||||0.031|TWO_SIDED|95.0|1.17|25.77|||Regression, Logistic|||||25.77|1.17|0.031
72591099|NCT01340027|144713798|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|3.84||||0.059|TWO_SIDED|95.0|0.95|15.58|||Regression, Logistic|||||15.58|0.95|0.059
72591100|NCT01340027|144713798|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.91||||0.36|TWO_SIDED|95.0|0.48|7.58|||Regression, Logistic|||||7.58|0.48|0.36
72591101|NCT01340027|144713798|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.34||||0.26|TWO_SIDED|95.0|0.05|2.17|||Regression, Logistic|||||2.17|0.05|0.26
72591102|NCT01340027|144713798|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.43||||0.33|TWO_SIDED|95.0|0.08|2.31|||Regression, Logistic|||||2.31|0.08|0.33
72591103|NCT01340027|144713798|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.07||||0.94|TWO_SIDED|95.0|0.17|6.68|||Regression, Logistic|||||6.68|0.17|0.94
72591104|NCT01340027|144713798|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.44||||0.29|TWO_SIDED|95.0|0.09|2.02|||Regression, Logistic|||||2.02|0.09|0.29
72591105|NCT01340027|144713798|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.28||||0.15|TWO_SIDED|95.0|0.05|1.6|||Regression, Logistic|||||1.60|0.05|0.15
72591106|NCT01340027|144713798|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.29||||0.11|TWO_SIDED|95.0|0.06|1.34|||Regression, Logistic|||||1.34|0.06|0.11
72414379|NCT00626522|144337982|SUPERIORITY_OR_OTHER||Least squares mean difference|0.206|STANDARD_ERROR_OF_MEAN|0.038|<|0.0001|TWO_SIDED|95.0|0.131|0.28|||ANCOVA|||||0.280|0.131|<0.0001
72414380|NCT00626522|144337982|SUPERIORITY_OR_OTHER||Least squares mean difference|0.254|STANDARD_ERROR_OF_MEAN|0.038|<|0.0001|TWO_SIDED|95.0|0.18|0.329|||ANCOVA|||||0.329|0.180|<0.0001
72414381|NCT00626522|144337982|SUPERIORITY_OR_OTHER||Least squares mean difference|0.265|STANDARD_ERROR_OF_MEAN|0.038|<|0.0001|TWO_SIDED|95.0|0.191|0.34|||ANCOVA|||||0.340|0.191|<0.0001
72414382|NCT00581230|144337994|SUPERIORITY_OR_OTHER|||||||0.0003||95.0|||||Wilcoxon signed rank test|||||||0.0003
72414383|NCT00581230|144337995|SUPERIORITY_OR_OTHER|||||||0.0001||95.0|||||Wilcoxon signed rank test|||||||0.0001
72591107|NCT01340027|144713798|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.41||||0.26|TWO_SIDED|95.0|0.09|1.89|||Regression, Logistic|||||1.89|0.09|0.26
72591108|NCT01340027|144713798|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.67||||0.28|TWO_SIDED|95.0|0.44|16.17|||Regression, Logistic|||||16.17|0.44|0.28
72591109|NCT01340027|144713798|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.39||||0.36|TWO_SIDED|95.0|0.37|15.46|||Regression, Logistic|||||15.46|0.37|0.36
72591110|NCT01340027|144713798|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.68||||0.56|TWO_SIDED|95.0|0.29|9.72|||Regression, Logistic|||||9.72|0.29|0.56
72591111|NCT01340027|144713798|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.83||||0.84|TWO_SIDED|95.0|0.15|4.76|||Regression, Logistic|||||4.76|0.15|0.84
72591112|NCT01340027|144713799|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.61||||0.48|TWO_SIDED|95.0|0.16|2.38|||Regression, Logistic|||"All statistical comparisons are for End of Treatment using 2-sided tests at the 0.05 significance level. No adjustment for multiple testing was performed.~The logistic regression model includes the 2 main factors mirabegron dose and solifenacin dose and their interaction, sex, age group and geographic region as fixed factors and baseline measurement as a covariate."||2.38|0.16|0.48
72591113|NCT01340027|144713799|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.74||||0.58|TWO_SIDED|95.0|0.25|2.17|||Regression, Logistic|||||2.17|0.25|0.58
72591114|NCT01340027|144713799|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.05||||0.93|TWO_SIDED|95.0|0.34|3.28|||Regression, Logistic|||||3.28|0.34|0.93
72591115|NCT01340027|144713799|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|12.16||||0.023|TWO_SIDED|95.0|1.4|105.3|||Regression, Logistic|||||105.30|1.40|0.023
72591116|NCT01340027|144713799|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|9.48||||0.042|TWO_SIDED|95.0|1.08|83.24|||Regression, Logistic|||||83.24|1.08|0.042
72591117|NCT01340027|144713799|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|9.03||||0.047|TWO_SIDED|95.0|1.03|79.19|||Regression, Logistic|||||79.19|1.03|0.047
72591118|NCT01340027|144713799|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.79||||0.23|TWO_SIDED|95.0|0.52|14.9|||Regression, Logistic|||||14.90|0.52|0.23
72591119|NCT01340027|144713799|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.1||||0.058|TWO_SIDED|95.0|0.01|1.08|||Regression, Logistic|||||1.08|0.01|0.058
72591120|NCT01340027|144713799|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.18||||0.15|TWO_SIDED|95.0|0.02|1.87|||Regression, Logistic|||||1.87|0.02|0.15
72591121|NCT01340027|144713799|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.46||||0.55|TWO_SIDED|95.0|0.04|5.99|||Regression, Logistic|||||5.99|0.04|0.55
72591122|NCT01340027|144713799|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.16||||0.11|TWO_SIDED|95.0|0.02|1.48|||Regression, Logistic|||||1.48|0.02|0.11
72591123|NCT01340027|144713799|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.1||||0.054|TWO_SIDED|95.0|0.01|1.05|||Regression, Logistic|||||1.05|0.01|0.054
72414384|NCT01944631|144338034|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.613|STANDARD_ERROR_OF_MEAN|0.359||0.0895|TWO_SIDED|95.0|-1.321|0.095|||ANCOVA||Difference calculated as bisolviral minus placebo|||0.095|-1.321|0.0895
72591124|NCT01340027|144713799|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.12||||0.059|TWO_SIDED|95.0|0.01|1.08|||Regression, Logistic|||||1.08|0.01|0.059
72591125|NCT01340027|144713799|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.17||||0.12|TWO_SIDED|95.0|0.02|1.58|||Regression, Logistic|||||1.58|0.02|0.12
72591126|NCT01340027|144713799|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.0||||0.64|TWO_SIDED|95.0|0.11|35.46|||Regression, Logistic|||||35.46|0.11|0.64
72591127|NCT01340027|144713799|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.56||||0.76|TWO_SIDED|95.0|0.09|27.42|||Regression, Logistic|||||27.42|0.09|0.76
72591128|NCT01340027|144713799|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.49||||0.79|TWO_SIDED|95.0|0.08|26.47|||Regression, Logistic|||||26.47|0.08|0.79
72591129|NCT01340027|144713799|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.46||||0.55|TWO_SIDED|95.0|0.04|5.77|||Regression, Logistic|||||5.77|0.04|0.55
72591130|NCT01340027|144713800|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.27|STANDARD_ERROR_OF_MEAN|0.495||0.25|TWO_SIDED|95.0|-1.24|0.71||All statistical comparisons are for change from Baseline to End of Treatment using 2-sided tests at the 0.05 significance level. No adjustment for multiple testing was performed.|Stratified Rank ANCOVA|P-values are from pairwise comparisons of the combination/active treatment groups vs. solifenacin 5 mg/placebo within a stratified rank ANCOVA model.||The ANCOVA model including the 2 main factors mirabegron dose and solifenacin dose and their interaction, sex, age group and geographic region as fixed factors and Baseline measurement as a covariate was used to calculate point estimates and 95% confidence intervals for change from Baseline within each treatment group and for differences between combination treatment groups and solifenacin 5 mg as well as for differences between active treatment groups and placebo.||0.71|-1.24|0.25
72591131|NCT01340027|144713800|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.05|STANDARD_ERROR_OF_MEAN|0.383||0.35|TWO_SIDED|95.0|-0.7|0.81|||Stratified Rank ANCOVA|||||0.81|-0.70|0.35
72591132|NCT01340027|144713800|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.371||1|TWO_SIDED|95.0|-0.74|0.72|||Stratified Rank ANCOVA|||||0.72|-0.74|1.0
72591133|NCT01340027|144713800|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.34|STANDARD_ERROR_OF_MEAN|0.377||0.003|TWO_SIDED|95.0|-1.08|0.41|||Stratified Rank ANCOVA|||||0.41|-1.08|0.003
72591134|NCT01340027|144713800|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.413||0.12|TWO_SIDED|95.0|-1.04|0.59|||Stratified Rank ANCOVA|||||0.59|-1.04|0.12
72591135|NCT01340027|144713800|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.58|STANDARD_ERROR_OF_MEAN|0.405||0.24|TWO_SIDED|95.0|-0.21|1.38|||Stratified Rank ANCOVA|||||1.38|-0.21|0.24
72591136|NCT01340027|144713800|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.435||0.54|TWO_SIDED|95.0|-0.94|0.78|||Stratified Rank ANCOVA|||||0.78|-0.94|0.54
72591137|NCT01340027|144713800|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.06|STANDARD_ERROR_OF_MEAN|0.59||0.95|TWO_SIDED|95.0|-1.1|1.22|||Stratified Rank ANCOVA|||||1.22|-1.10|0.95
72591138|NCT01340027|144713800|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.552||0.74|TWO_SIDED|95.0|-1.11|1.07|||Stratified Rank ANCOVA|||||1.07|-1.11|0.74
72591139|NCT01340027|144713800|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.31|STANDARD_ERROR_OF_MEAN|0.57||0.89|TWO_SIDED|95.0|-1.43|0.82|||Stratified Rank ANCOVA|||||0.82|-1.43|0.89
72591140|NCT01340027|144713800|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.487||0.82|TWO_SIDED|95.0|-0.96|0.96|||Stratified Rank ANCOVA|||||0.96|-0.96|0.82
72591141|NCT01340027|144713800|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.27|STANDARD_ERROR_OF_MEAN|0.593||0.58|TWO_SIDED|95.0|-1.44|0.9|||Stratified Rank ANCOVA|||||0.90|-1.44|0.58
72591142|NCT01340027|144713800|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.05|STANDARD_ERROR_OF_MEAN|0.5||0.46|TWO_SIDED|95.0|-0.93|1.04|||Stratified Rank ANCOVA|||||1.04|-0.93|0.46
72591143|NCT01340027|144713800|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.49||0.95|TWO_SIDED|95.0|-0.97|0.96|||Stratified Rank ANCOVA|||||0.96|-0.97|0.95
72591144|NCT01340027|144713800|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.34|STANDARD_ERROR_OF_MEAN|0.499||0.18|TWO_SIDED|95.0|-1.32|0.65|||Stratified Rank ANCOVA|||||0.65|-1.32|0.18
72591145|NCT01340027|144713800|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.517||0.21|TWO_SIDED|95.0|-1.24|0.8|||Stratified Rank ANCOVA|||||0.80|-1.24|0.21
72591146|NCT01340027|144713800|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.58|STANDARD_ERROR_OF_MEAN|0.516||0.72|TWO_SIDED|95.0|-0.43|1.6|||Stratified Rank ANCOVA|||||1.60|-0.43|0.72
72591147|NCT01340027|144713800|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.541||0.92|TWO_SIDED|95.0|-1.15|0.98|||Stratified Rank ANCOVA|||||0.98|-1.15|0.92
72591148|NCT01340027|144713801|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.26|STANDARD_ERROR_OF_MEAN|0.412||0.002|TWO_SIDED|95.0|-2.06|-0.45|||ANCOVA|||"All statistical comparisons are for change from Baseline to End of Treatment using 2-sided tests at the 0.05 significance level. No adjustment for multiple testing was performed.~The ANCOVA model includes the 2 main factors mirabegron dose and solifenacin dose and their interaction, sex, age group and geographic region as fixed factors and baseline measurement as a covariate.~LS Mean Differences were calculated by subtracting Solifenacin 5 mg/Placebo from the comparison treatment group."||-0.45|-2.06|0.002
72591149|NCT01340027|144713801|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.48|STANDARD_ERROR_OF_MEAN|0.34||0.16|TWO_SIDED|95.0|-1.15|0.19|||ANCOVA|||||0.19|-1.15|0.16
72591150|NCT01340027|144713801|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.24|STANDARD_ERROR_OF_MEAN|0.34|<|0.001|TWO_SIDED|95.0|-1.91|-0.57|||ANCOVA|||||-0.57|-1.91|<0.001
72591151|NCT01340027|144713801|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.13|STANDARD_ERROR_OF_MEAN|0.343||0.001|TWO_SIDED|95.0|-1.8|-0.46|||ANCOVA|||||-0.46|-1.80|0.001
72591152|NCT01340027|144713801|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.37|STANDARD_ERROR_OF_MEAN|0.338|<|0.001|TWO_SIDED|95.0|-2.03|-0.7|||ANCOVA|||||-0.70|-2.03|<0.001
72591153|NCT01340027|144713801|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.98|STANDARD_ERROR_OF_MEAN|0.409||0.017|TWO_SIDED|95.0|-1.78|-0.18|||ANCOVA|||||-0.18|-1.78|0.017
72591154|NCT01340027|144713801|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.18|STANDARD_ERROR_OF_MEAN|0.405||0.004|TWO_SIDED|95.0|-1.98|-0.39|||ANCOVA|||||-0.39|-1.98|0.004
72591155|NCT01340027|144713801|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.29|STANDARD_ERROR_OF_MEAN|0.469||0.53|TWO_SIDED|95.0|-0.63|1.22|||ANCOVA|||||1.22|-0.63|0.53
72591156|NCT01340027|144713801|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.09|STANDARD_ERROR_OF_MEAN|0.468||0.85|TWO_SIDED|95.0|-0.83|1.01|||ANCOVA|||||1.01|-0.83|0.85
72591157|NCT01340027|144713801|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.468||0.84|TWO_SIDED|95.0|-1.01|0.83|||ANCOVA|||||0.83|-1.01|0.84
72591158|NCT01340027|144713801|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.8|STANDARD_ERROR_OF_MEAN|0.406||0.05|TWO_SIDED|95.0|0.0|1.59|||ANCOVA|||||1.59|-0.00|0.050
72591159|NCT01340027|144713801|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.46|STANDARD_ERROR_OF_MEAN|0.469||0.33|TWO_SIDED|95.0|-1.38|0.46|||ANCOVA|||||0.46|-1.38|0.33
72591160|NCT01340027|144713801|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.32|STANDARD_ERROR_OF_MEAN|0.407||0.44|TWO_SIDED|95.0|-0.48|1.12|||ANCOVA|||||1.12|-0.48|0.44
72591161|NCT01340027|144713801|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.44|STANDARD_ERROR_OF_MEAN|0.408||0.28|TWO_SIDED|95.0|-1.24|0.36|||ANCOVA|||||0.36|-1.24|0.28
72591162|NCT01340027|144713801|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.33|STANDARD_ERROR_OF_MEAN|0.41||0.42|TWO_SIDED|95.0|-1.14|0.47|||ANCOVA|||||0.47|-1.14|0.42
72591163|NCT01340027|144713801|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.57|STANDARD_ERROR_OF_MEAN|0.406||0.16|TWO_SIDED|95.0|-1.37|0.23|||ANCOVA|||||0.23|-1.37|0.16
72591164|NCT01340027|144713801|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.467||0.7|TWO_SIDED|95.0|-1.1|0.73|||ANCOVA|||||0.73|-1.10|0.70
72591165|NCT01340027|144713801|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.39|STANDARD_ERROR_OF_MEAN|0.464||0.4|TWO_SIDED|95.0|-1.3|0.52|||ANCOVA|||||0.52|-1.30|0.40
72591166|NCT01340027|144713802|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.079||0.062|TWO_SIDED|95.0|-0.3|0.01|||ANCOVA|||"All statistical comparisons are for change from Baseline to End of Treatment using 2-sided tests at the 0.05 significance level. No adjustment for multiple testing was performed.~The ANCOVA model includes the 2 main factors mirabegron dose and solifenacin dose and their interaction, sex, age group and geographic region as fixed factors and baseline measurement as a covariate.~LS Mean Differences were calculated by subtracting Solifenacin 5 mg/Placebo from the comparison treatment group."||0.01|-0.30|0.062
72591167|NCT01340027|144713802|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.065||0.15|TWO_SIDED|95.0|-0.22|0.03|||ANCOVA|||||0.03|-0.22|0.15
72591168|NCT01340027|144713802|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.065||0.007|TWO_SIDED|95.0|-0.3|-0.05|||ANCOVA|||||-0.05|-0.30|0.007
72591169|NCT01340027|144713802|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.066||0.017|TWO_SIDED|95.0|-0.29|-0.03|||ANCOVA|||||-0.03|-0.29|0.017
72591170|NCT01340027|144713802|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.23|STANDARD_ERROR_OF_MEAN|0.065|<|0.001|TWO_SIDED|95.0|-0.35|-0.1|||ANCOVA|||||-0.10|-0.35|<0.001
72591171|NCT01340027|144713802|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.26|STANDARD_ERROR_OF_MEAN|0.078|<|0.001|TWO_SIDED|95.0|-0.41|-0.11|||ANCOVA|||||-0.11|-0.41|<0.001
72591172|NCT01340027|144713802|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.077||0.07|TWO_SIDED|95.0|-0.29|0.01|||ANCOVA|||||0.01|-0.29|0.070
72591173|NCT01340027|144713802|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.13|STANDARD_ERROR_OF_MEAN|0.09||0.15|TWO_SIDED|95.0|-0.05|0.31|||ANCOVA|||||0.31|-0.05|0.15
72591174|NCT01340027|144713802|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.05|STANDARD_ERROR_OF_MEAN|0.089||0.57|TWO_SIDED|95.0|-0.12|0.23|||ANCOVA|||||0.23|-0.12|0.57
72591175|NCT01340027|144713802|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.089||0.89|TWO_SIDED|95.0|-0.16|0.19|||ANCOVA|||||0.19|-0.16|0.89
72591176|NCT01340027|144713802|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.13|STANDARD_ERROR_OF_MEAN|0.077||0.086|TWO_SIDED|95.0|-0.02|0.29|||ANCOVA|||||0.29|-0.02|0.086
72591177|NCT01340027|144713802|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.09||0.88|TWO_SIDED|95.0|-0.19|0.16|||ANCOVA|||||0.16|-0.19|0.88
72591178|NCT01340027|144713802|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.04|STANDARD_ERROR_OF_MEAN|0.078||0.61|TWO_SIDED|95.0|-0.11|0.19|||ANCOVA|||||0.19|-0.11|0.61
72591179|NCT01340027|144713802|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.078||0.58|TWO_SIDED|95.0|-0.2|0.11|||ANCOVA|||||0.11|-0.20|0.58
72591180|NCT01340027|144713802|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.078||0.76|TWO_SIDED|95.0|-0.18|0.13|||ANCOVA|||||0.13|-0.18|0.76
72591181|NCT01340027|144713802|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.09|STANDARD_DEVIATION|0.077||0.23|TWO_SIDED|95.0|-0.25|0.06|||ANCOVA|||||0.06|-0.25|0.23
72591182|NCT01340027|144713802|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.089||0.15|TWO_SIDED|95.0|-0.3|0.05|||ANCOVA|||||0.05|-0.30|0.15
72591183|NCT01340027|144713802|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.088||0.94|TWO_SIDED|95.0|-0.18|0.17|||ANCOVA|||||0.17|-0.18|0.94
72591184|NCT01340027|144713803|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.35|STANDARD_ERROR_OF_MEAN|0.33||0.29|TWO_SIDED|95.0|-0.99|0.3|||ANCOVA|||"All statistical comparisons are for change from Baseline to End of Treatment using 2-sided tests at the 0.05 significance level. No adjustment for multiple testing was performed.~The ANCOVA model includes the 2 main factors mirabegron dose and solifenacin dose and their interaction, sex, age group and geographic region as fixed factors and baseline measurement as a covariate.~LS Mean Differences were calculated by subtracting Solifenacin 5 mg/Placebo from the comparison treatment group."||0.30|-0.99|0.29
72591185|NCT01340027|144713803|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.35|STANDARD_ERROR_OF_MEAN|0.239||0.15|TWO_SIDED|95.0|-0.12|0.82|||ANCOVA|||||0.82|-0.12|0.15
72591186|NCT01340027|144713803|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.248||0.99|TWO_SIDED|95.0|-0.48|0.49|||ANCOVA|||||0.49|-0.48|0.99
72591187|NCT01340027|144713803|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.239||0.76|TWO_SIDED|95.0|-0.54|0.4|||ANCOVA|||||0.40|-0.54|0.76
72591188|NCT01340027|144713803|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.25|STANDARD_ERROR_OF_MEAN|0.238||0.3|TWO_SIDED|95.0|-0.71|0.22|||ANCOVA|||||0.22|-0.71|0.30
72591189|NCT01340027|144713803|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.21|STANDARD_ERROR_OF_MEAN|0.262||0.43|TWO_SIDED|95.0|-0.72|0.31|||ANCOVA|||||0.31|-0.72|0.43
72591190|NCT01340027|144713803|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.25|STANDARD_ERROR_OF_MEAN|0.296||0.4|TWO_SIDED|95.0|-0.83|0.33|||ANCOVA|||||0.33|-0.83|0.40
72591191|NCT01340027|144713803|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.343||0.24|TWO_SIDED|95.0|-1.08|0.27|||ANCOVA|||||0.27|-1.08|0.24
72591192|NCT01340027|144713803|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.31|STANDARD_ERROR_OF_MEAN|0.34||0.36|TWO_SIDED|95.0|-0.98|0.36|||ANCOVA|||||0.36|-0.98|0.36
72414385|NCT01944631|144338035|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.176|STANDARD_ERROR_OF_MEAN|0.146||0.231|TWO_SIDED|95.0|-0.464|0.113|||ANCOVA||Difference calculated as bisolviral minus placebo|||0.113|-0.464|0.2310
72591193|NCT01340027|144713803|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.81|STANDARD_ERROR_OF_MEAN|0.348||0.02|TWO_SIDED|95.0|-1.49|-0.13|||ANCOVA|||||-0.13|-1.49|0.020
72591194|NCT01340027|144713803|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.75|STANDARD_ERROR_OF_MEAN|0.293||0.011|TWO_SIDED|95.0|-1.33|-0.18|||ANCOVA|||||-0.18|-1.33|0.011
72591195|NCT01340027|144713803|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|0.377||0.004|TWO_SIDED|95.0|-1.84|-0.36|||ANCOVA|||||-0.36|-1.84|0.004
72591196|NCT01340027|144713803|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.301||0.18|TWO_SIDED|95.0|-1.0|0.19|||ANCOVA|||||0.19|-1.00|0.18
72591197|NCT01340027|144713803|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.75|STANDARD_ERROR_OF_MEAN|0.308||0.015|TWO_SIDED|95.0|-1.35|-0.14|||ANCOVA|||||-0.14|-1.35|0.015
72591198|NCT01340027|144713803|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.82|STANDARD_ERROR_OF_MEAN|0.301||0.006|TWO_SIDED|95.0|-1.41|-0.23|||ANCOVA|||||-0.23|-1.41|0.006
72591199|NCT01340027|144713803|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.3|<|0.001|TWO_SIDED|95.0|-1.59|-0.41|||ANCOVA|||||-0.41|-1.59|<0.001
72591200|NCT01340027|144713803|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.96|STANDARD_ERROR_OF_MEAN|0.32||0.003|TWO_SIDED|95.0|-1.59|-0.33|||ANCOVA|||||-0.33|-1.59|0.003
72591201|NCT01340027|144713803|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.348||0.004|TWO_SIDED|95.0|-1.68|-0.31|||ANCOVA|||||-0.31|-1.68|0.004
72591202|NCT01340027|144713804|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.25|STANDARD_ERROR_OF_MEAN|0.177||0.15|TWO_SIDED|95.0|-0.6|0.09|||ANCOVA|||"All statistical comparisons are for change from Baseline to End of Treatment using 2-sided tests at the 0.05 significance level. No adjustment for multiple testing was performed.~The ANCOVA model includes the 2 main factors mirabegron dose and solifenacin dose and their interaction, sex, age group and geographic region as fixed factors and baseline measurement as a covariate.~LS Mean Differences were calculated by subtracting Solifenacin 5 mg/Placebo from the comparison treatment group."||0.09|-0.60|0.15
72591203|NCT01340027|144713804|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.146||0.78|TWO_SIDED|95.0|-0.33|0.25|||ANCOVA|||||0.25|-0.33|0.78
72591204|NCT01340027|144713804|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.146||0.58|TWO_SIDED|95.0|-0.37|0.21|||ANCOVA|||||0.21|-0.37|0.58
72591205|NCT01340027|144713804|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.147||0.6|TWO_SIDED|95.0|-0.37|0.21|||ANCOVA|||||0.21|-0.37|0.60
72591206|NCT01340027|144713804|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.35|STANDARD_ERROR_OF_MEAN|0.145||0.017|TWO_SIDED|95.0|-0.63|-0.06|||ANCOVA|||||-0.06|-0.63|0.017
72591207|NCT01340027|144713804|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.25|STANDARD_ERROR_OF_MEAN|0.176||0.16|TWO_SIDED|95.0|-0.6|0.1|||ANCOVA|||||0.10|-0.60|0.16
72591208|NCT01340027|144713804|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.27|STANDARD_ERROR_OF_MEAN|0.175||0.13|TWO_SIDED|95.0|-0.61|0.08|||ANCOVA|||||0.08|-0.61|0.13
72591209|NCT01340027|144713804|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.05|STANDARD_ERROR_OF_MEAN|0.201||0.81|TWO_SIDED|95.0|-0.35|0.44|||ANCOVA|||||0.44|-0.35|0.81
72591210|NCT01340027|144713804|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.199||0.67|TWO_SIDED|95.0|-0.48|0.31|||ANCOVA|||||0.31|-0.48|0.67
72591211|NCT01340027|144713804|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.06|STANDARD_ERROR_OF_MEAN|0.2||0.77|TWO_SIDED|95.0|-0.33|0.45|||ANCOVA|||||0.45|-0.33|0.77
72414386|NCT01944631|144338036|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.443|STANDARD_ERROR_OF_MEAN|0.304||0.1465|TWO_SIDED|95.0|-1.042|0.156|||ANCOVA||Difference calculated as bisolviral minus placebo|||0.156|-1.042|0.1465
72591212|NCT01340027|144713804|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.04|STANDARD_ERROR_OF_MEAN|0.81||0.81|TWO_SIDED|95.0|-0.3|0.38|||ANCOVA|||||0.38|-0.30|0.81
72591213|NCT01340027|144713804|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.21|STANDARD_ERROR_OF_MEAN|0.201||0.3|TWO_SIDED|95.0|-0.6|0.18|||ANCOVA|||||0.18|-0.60|0.30
72591214|NCT01340027|144713804|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.174||0.99|TWO_SIDED|95.0|-0.34|0.34|||ANCOVA|||||0.34|-0.34|0.99
72591215|NCT01340027|144713804|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.175||0.82|TWO_SIDED|95.0|-0.38|0.3|||ANCOVA|||||0.30|-0.38|0.82
72591216|NCT01340027|144713804|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.175||0.84|TWO_SIDED|95.0|-0.38|0.31|||ANCOVA|||||0.31|-0.38|0.84
72591217|NCT01340027|144713804|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.173||0.08|TWO_SIDED|95.0|-0.64|0.04|||ANCOVA|||||0.04|-0.64|0.080
72591218|NCT01340027|144713804|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.21|STANDARD_ERROR_OF_MEAN|0.2||0.3|TWO_SIDED|95.0|-0.6|0.18|||ANCOVA|||||0.18|-0.60|0.30
72591219|NCT01340027|144713804|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.199||0.26|TWO_SIDED|95.0|-0.62|0.17|||ANCOVA|||||0.17|-0.62|0.26
72591220|NCT01340027|144713805|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.17||0.38|TWO_SIDED|95.0|-0.5|0.2|||ANCOVA|||"Statistical comparisons were made using 2-sided tests at the 0.05 significance level. No adjustment for multiple testing was performed.~The ANCOVA model for all pairwise comparisons includes the 2 main factors mirabegron dose and solifenacin succinate dose and their interaction, sex, age group and geographic region as fixed factors and baseline measurement as a covariate.~LS Mean Differences were calculated by subtracting Solifenacin 5 mg/Placebo from the comparison treatment group."||0.2|-0.5|0.38
72591221|NCT01340027|144713805|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.14||0.85|TWO_SIDED|95.0|-0.3|0.3|||ANCOVA|||||0.3|-0.3|0.85
72591222|NCT01340027|144713805|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.14||0.024|TWO_SIDED|95.0|-0.6|0.0|||ANCOVA|||||-0.0|-0.6|0.024
72591223|NCT01340027|144713805|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.14||0.005|TWO_SIDED|95.0|-0.7|-0.1|||ANCOVA|||||-0.1|-0.7|0.005
72591224|NCT01340027|144713805|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.14||0.003|TWO_SIDED|95.0|-0.7|-0.1|||ANCOVA|||||-0.1|-0.7|0.003
72591225|NCT01340027|144713805|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.17||0.004|TWO_SIDED|95.0|-0.8|-0.2|||ANCOVA|||||-0.2|-0.8|0.004
72591226|NCT01340027|144713805|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.17||0.15|TWO_SIDED|95.0|-0.6|0.1|||ANCOVA|||||0.1|-0.6|0.15
72591227|NCT01340027|144713805|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.2||0.99|TWO_SIDED|95.0|-0.4|0.4|||ANCOVA|||||0.4|-0.4|0.99
72591228|NCT01340027|144713805|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.19||0.67|TWO_SIDED|95.0|-0.5|0.3|||ANCOVA|||||0.3|-0.5|0.67
72591229|NCT01340027|144713805|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.19||0.44|TWO_SIDED|95.0|-0.5|0.2|||ANCOVA|||||0.2|-0.5|0.44
72591230|NCT01340027|144713805|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.17||0.88|TWO_SIDED|95.0|-0.3|0.4|||ANCOVA|||||0.4|-0.3|0.88
72591231|NCT01340027|144713805|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.2||0.53|TWO_SIDED|95.0|-0.5|0.3|||ANCOVA|||||0.3|-0.5|0.53
72591232|NCT01340027|144713805|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.17||1|TWO_SIDED|95.0|-0.3|0.3|||ANCOVA|||||0.3|-0.3|1.0
72591233|NCT01340027|144713805|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.17||0.084|TWO_SIDED|95.0|-0.6|0.0|||ANCOVA|||||0.0|-0.6|0.084
72591234|NCT01340027|144713805|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.17||0.03|TWO_SIDED|95.0|-0.7|0.0|||ANCOVA|||||-0.0|-0.7|0.030
72591235|NCT01340027|144713805|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.17||0.02|TWO_SIDED|95.0|-0.7|-0.1|||ANCOVA|||||-0.1|-0.7|0.020
72591236|NCT01340027|144713805|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.19||0.017|TWO_SIDED|95.0|-0.8|-0.1|||ANCOVA|||||-0.1|-0.8|0.017
72591237|NCT01340027|144713805|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.19||0.26|TWO_SIDED|95.0|-0.6|0.2|||ANCOVA|||||0.2|-0.6|0.26
72591238|NCT01340027|144713806|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.26||||0.04|TWO_SIDED|95.0|1.04|4.95|||Regression, Logistic|||"All statistical comparisons are for End of Treatment using 2-sided tests at the 0.05 significance level. No adjustment for multiple testing was performed.~The logistic regression model includes the 2 main factors mirabegron dose and solifenacin dose and their interaction, sex, age group and geographic region as fixed factors and baseline measurement as a covariate."||4.95|1.04|0.040
72591239|NCT01340027|144713806|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.1||||0.73|TWO_SIDED|95.0|0.63|1.92|||Regression, Logistic|||||1.92|0.63|0.73
72414387|NCT01944631|144338037|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.728|STANDARD_ERROR_OF_MEAN|3.102||0.8148|TWO_SIDED|95.0|-5.39|6.845|||ANCOVA||Difference calculated as bisolviral minus placebo|||6.845|-5.390|0.8148
72591240|NCT01340027|144713806|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.82||||0.05|TWO_SIDED|95.0|1.0|3.3|||Regression, Logistic|||||3.30|1.00|0.050
72591241|NCT01340027|144713806|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.45||||0.21|TWO_SIDED|95.0|0.81|2.59|||Regression, Logistic|||||2.59|0.81|0.21
72591242|NCT01340027|144713806|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.02||||0.021|TWO_SIDED|95.0|1.11|3.66|||Regression, Logistic|||||3.66|1.11|0.021
72591243|NCT01340027|144713806|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.64||||0.19|TWO_SIDED|95.0|0.79|3.4|||Regression, Logistic|||||3.40|0.79|0.19
72591244|NCT01340027|144713806|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.12||||0.74|TWO_SIDED|95.0|0.57|2.19|||Regression, Logistic|||||2.19|0.57|0.74
72591245|NCT01340027|144713806|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.25||||0.57|TWO_SIDED|95.0|0.58|2.71|||Regression, Logistic|||||2.71|0.58|0.57
72591246|NCT01340027|144713806|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.67||||0.19|TWO_SIDED|95.0|0.77|3.64|||Regression, Logistic|||||3.64|0.77|0.19
72591247|NCT01340027|144713806|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.86||||0.69|TWO_SIDED|95.0|0.41|1.79|||Regression, Logistic|||||1.79|0.41|0.69
72591248|NCT01340027|144713806|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.04||||0.9|TWO_SIDED|95.0|0.55|1.99|||Regression, Logistic|||||1.99|0.55|0.90
72591249|NCT01340027|144713806|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.36||||0.048|TWO_SIDED|95.0|1.01|5.55|||Regression, Logistic|||||5.55|1.01|0.048
72591250|NCT01340027|144713806|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.15||||0.67|TWO_SIDED|95.0|0.6|2.22|||Regression, Logistic|||||2.22|0.60|0.67
72591251|NCT01340027|144713806|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.9||||0.07|TWO_SIDED|95.0|0.95|3.78|||Regression, Logistic|||||3.78|0.95|0.070
72591252|NCT01340027|144713806|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.51||||0.23|TWO_SIDED|95.0|0.77|2.98|||Regression, Logistic|||||2.98|0.77|0.23
72591253|NCT01340027|144713806|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.11||||0.034|TWO_SIDED|95.0|1.06|4.19|||Regression, Logistic|||||4.19|1.06|0.034
72591254|NCT01340027|144713806|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.71||||0.2|TWO_SIDED|95.0|0.76|3.84|||Regression, Logistic|||||3.84|0.76|0.20
72591255|NCT01340027|144713806|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.17||||0.68|TWO_SIDED|95.0|0.55|2.49|||Regression, Logistic|||||2.49|0.55|0.68
72591256|NCT01340027|144713807|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.16||||0.62|TWO_SIDED|95.0|0.64|2.12|||Regression, Logistic|||||2.12|0.64|0.62
72591257|NCT01340027|144713807|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.33||||0.25|TWO_SIDED|95.0|0.82|2.17|||Regression, Logistic|||||2.17|0.82|0.25
72591258|NCT01340027|144713807|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.48||||0.11|TWO_SIDED|95.0|0.91|2.41|||Regression, Logistic|||||2.41|0.91|0.11
72591259|NCT01340027|144713807|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.81||||0.02|TWO_SIDED|95.0|1.1|2.97|||Regression, Logistic|||||2.97|1.10|0.020
72591260|NCT01340027|144713807|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.87||||0.012|TWO_SIDED|95.0|1.15|3.05|||Regression, Logistic|||||3.05|1.15|0.012
72591261|NCT01340027|144713807|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.72||||0.072|TWO_SIDED|95.0|0.95|3.1|||Regression, Logistic|||||3.10|0.95|0.072
72591262|NCT01340027|144713807|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.37||||0.29|TWO_SIDED|95.0|0.77|2.44|||Regression, Logistic|||||2.44|0.77|0.29
72591263|NCT01340027|144713807|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.98||||0.94|TWO_SIDED|95.0|0.49|1.93|||Regression, Logistic|||||1.93|0.49|0.94
72591264|NCT01340027|144713807|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.91||||0.8|TWO_SIDED|95.0|0.46|1.81|||Regression, Logistic|||||1.81|0.46|0.80
72591265|NCT01340027|144713807|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.16||||0.67|TWO_SIDED|95.0|0.59|2.28|||Regression, Logistic|||||2.28|0.59|0.67
72591266|NCT01340027|144713807|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.0||||1|TWO_SIDED|95.0|0.55|1.8|||Regression, Logistic|||||1.80|0.55|1.0
72591267|NCT01340027|144713807|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.16||||0.66|TWO_SIDED|95.0|0.59|2.31|||Regression, Logistic|||||2.31|0.59|0.66
72591268|NCT01340027|144713807|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.33||||0.35|TWO_SIDED|95.0|0.73|2.4|||Regression, Logistic|||||2.40|0.73|0.35
72591269|NCT01340027|144713807|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.48||||0.19|TWO_SIDED|95.0|0.82|2.67|||Regression, Logistic|||||2.67|0.82|0.19
72591270|NCT01340027|144713807|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.8||||0.054|TWO_SIDED|95.0|0.99|3.28|||Regression, Logistic|||||3.28|0.99|0.054
72591271|NCT01340027|144713807|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.87||||0.038|TWO_SIDED|95.0|1.04|3.38|||Regression, Logistic|||||3.38|1.04|0.038
72591272|NCT01340027|144713807|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.72||||0.12|TWO_SIDED|95.0|0.87|3.39|||Regression, Logistic|||||3.39|0.87|0.12
72591273|NCT01340027|144713807|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.37||||0.36|TWO_SIDED|95.0|0.7|2.67|||Regression, Logistic|||||2.67|0.70|0.36
72591274|NCT01340027|144713808|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.4||||0.32|TWO_SIDED|95.0|0.06|2.43|||Regression, Logistic|||"All statistical comparisons are for End of Treatment using 2-sided tests at the 0.05 significance level. No adjustment for multiple testing was performed.~The logistic regression model includes the 2 main factors mirabegron dose and solifenacin dose and their interaction, sex, age group and geographic region as fixed factors and baseline measurement as a covariate."||2.43|0.06|0.32
72591275|NCT01340027|144713808|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.75||||0.65|TWO_SIDED|95.0|0.21|2.61|||Regression, Logistic|||||2.61|0.21|0.65
72591276|NCT01340027|144713808|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.54||||0.39|TWO_SIDED|95.0|0.13|2.19|||Regression, Logistic|||||2.19|0.13|0.39
72591277|NCT01340027|144713808|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.41||||0.22|TWO_SIDED|95.0|0.1|1.67|||Regression, Logistic|||||1.67|0.10|0.22
72591278|NCT01340027|144713808|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.22||||0.082|TWO_SIDED|95.0|0.04|1.22|||Regression, Logistic|||||1.22|0.04|0.082
72591279|NCT01340027|144713808|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.36||||0.36|TWO_SIDED|95.0|0.04|3.2|||Regression, Logistic|||||3.20|0.04|0.36
72591280|NCT01340027|144713808|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.55||||0.51|TWO_SIDED|95.0|0.42|5.71|||Regression, Logistic|||||5.71|0.42|0.51
72591281|NCT01340027|144713808|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.01||||0.99|TWO_SIDED|95.0|0.19|5.36|||Regression, Logistic|||||5.36|0.19|0.99
72591282|NCT01340027|144713808|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.04||||0.96|TWO_SIDED|95.0|0.24|4.59|||Regression, Logistic|||||4.59|0.24|0.96
72591283|NCT01340027|144713808|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.62||||0.57|TWO_SIDED|95.0|0.12|3.3|||Regression, Logistic|||||3.30|0.12|0.57
72591284|NCT01340027|144713808|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.06||||0.93|TWO_SIDED|95.0|0.28|3.95|||Regression, Logistic|||||3.95|0.28|0.93
72591285|NCT01340027|144713808|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.42||||0.37|TWO_SIDED|95.0|0.06|2.79|||Regression, Logistic|||||2.79|0.06|0.37
72591286|NCT01340027|144713808|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.79||||0.74|TWO_SIDED|95.0|0.2|3.13|||Regression, Logistic|||||3.13|0.20|0.74
72591287|NCT01340027|144713808|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.57||||0.46|TWO_SIDED|95.0|0.12|2.59|||Regression, Logistic|||||2.59|0.12|0.46
72591288|NCT01340027|144713808|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.44||||0.28|TWO_SIDED|95.0|0.1|1.96|||Regression, Logistic|||||1.96|0.10|0.28
72591289|NCT01340027|144713808|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.23||||0.11|TWO_SIDED|95.0|0.04|1.4|||Regression, Logistic|||||1.40|0.04|0.11
72591290|NCT01340027|144713808|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.38||||0.4|TWO_SIDED|95.0|0.04|3.66|||Regression, Logistic|||||3.66|0.04|0.40
72591291|NCT01340027|144713808|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.64||||0.5|TWO_SIDED|95.0|0.39|6.85|||Regression, Logistic|||||6.85|0.39|0.50
72414388|NCT01944631|144338038|SUPERIORITY_OR_OTHER|||||||0.1887|TWO_SIDED||||||Log Rank|Log-rank test stratifying for the variable 'baseline TSS'||||||0.1887
72591292|NCT01340027|144713809|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-3.1|STANDARD_ERROR_OF_MEAN|2.47||0.21|TWO_SIDED|95.0|-8.0|1.7|||ANCOVA|||"Statistical comparisons were made using 2-sided tests at the 0.05 significance level. No adjustment for multiple testing was performed.~The ANCOVA model for all pairwise comparisons includes the 2 main factors mirabegron dose and solifenacin succinate dose and their interaction, sex, age group and geographic region as fixed factors and baseline measurement as a covariate.~LS Mean Differences were calculated by subtracting Solifenacin 5 mg/Placebo from the comparison treatment group."||1.7|-8.0|0.21
72591293|NCT01340027|144713809|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.3|STANDARD_ERROR_OF_MEAN|2.03||0.54|TWO_SIDED|95.0|-5.2|2.7|||ANCOVA|||||2.7|-5.2|0.54
72591294|NCT01340027|144713809|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-4.9|STANDARD_ERROR_OF_MEAN|2.03||0.016|TWO_SIDED|95.0|-8.9|-0.9|||ANCOVA|||||-0.9|-8.9|0.016
72591295|NCT01340027|144713809|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-5.2|STANDARD_ERROR_OF_MEAN|2.05||0.011|TWO_SIDED|95.0|-9.3|-1.2|||ANCOVA|||||-1.2|-9.3|0.011
72591296|NCT01340027|144713809|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-6.7|STANDARD_ERROR_OF_MEAN|2.03|<|0.001|TWO_SIDED|95.0|-10.7|-2.8|||ANCOVA|||||-2.8|-10.7|<0.001
72591297|NCT01340027|144713809|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-6.8|STANDARD_ERROR_OF_MEAN|2.43||0.005|TWO_SIDED|95.0|-11.6|-2.0|||ANCOVA|||||-2.0|-11.6|0.005
72591298|NCT01340027|144713809|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-4.7|STANDARD_ERROR_OF_MEAN|2.44||0.056|TWO_SIDED|95.0|-9.4|0.1|||ANCOVA|||||0.1|-9.4|0.056
72591299|NCT01340027|144713809|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.6|STANDARD_ERROR_OF_MEAN|2.81||0.56|TWO_SIDED|95.0|-7.1|3.9|||ANCOVA|||||3.9|-7.1|0.56
72591300|NCT01340027|144713809|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-2.0|STANDARD_ERROR_OF_MEAN|2.8||0.48|TWO_SIDED|95.0|-7.5|3.5|||ANCOVA|||||3.5|-7.5|0.48
72591301|NCT01340027|144713809|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-4.3|STANDARD_ERROR_OF_MEAN|0.13||0.13|TWO_SIDED|95.0|-9.8|1.2|||ANCOVA|||||1.2|-9.8|0.13
72591302|NCT01340027|144713809|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|2.42||0.61|TWO_SIDED|95.0|-6.0|3.5|||ANCOVA|||||3.5|-6.0|0.61
72591303|NCT01340027|144713809|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-4.4|STANDARD_ERROR_OF_MEAN|2.81||0.12|TWO_SIDED|95.0|-9.9|1.2|||ANCOVA|||||1.2|-9.9|0.12
72591304|NCT01340027|144713809|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-2.5|STANDARD_ERROR_OF_MEAN|2.44||0.31|TWO_SIDED|95.0|-7.3|2.3|||ANCOVA|||||2.3|-7.3|0.31
72591305|NCT01340027|144713809|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-6.1|STANDARD_ERROR_OF_MEAN|2.44||0.012|TWO_SIDED|95.0|-10.9|-1.3|||ANCOVA|||||-1.3|-10.9|0.012
72591306|NCT01340027|144713809|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-6.5|STANDARD_ERROR_OF_MEAN|2.46||0.008|TWO_SIDED|95.0|-11.3|-1.7|||ANCOVA|||||-1.7|-11.3|0.008
72591307|NCT01340027|144713809|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-8.0|STANDARD_ERROR_OF_MEAN|2.44||0.001|TWO_SIDED|95.0|-12.8|-3.2|||ANCOVA|||||-3.2|-12.8|0.001
72591308|NCT01340027|144713809|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-8.0|STANDARD_ERROR_OF_MEAN|2.78||0.004|TWO_SIDED|95.0|-13.5|-2.6|||ANCOVA|||||-2.6|-13.5|0.004
72591309|NCT01340027|144713809|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-5.9|STANDARD_ERROR_OF_MEAN|2.79||0.035|TWO_SIDED|95.0|-11.4|-0.4|||ANCOVA|||||-0.4|-11.4|0.035
72591310|NCT01340027|144713810|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.42||||0.4|TWO_SIDED|95.0|0.63|3.2|||Regression, Logistic|||"All statistical comparisons are for End of Treatment using 2-sided tests at the 0.05 significance level. No adjustment for multiple testing was performed.~The logistic regression model includes the 2 main factors mirabegron dose and solifenacin dose and their interaction, sex, age group and geographic region as fixed factors and baseline measurement as a covariate."||3.20|0.63|0.40
72591311|NCT01340027|144713810|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.04||||0.89|TWO_SIDED|95.0|0.55|1.97|||Regression, Logistic|||||1.97|0.55|0.89
72591312|NCT01340027|144713810|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.21||||0.57|TWO_SIDED|95.0|0.63|2.33|||Regression, Logistic|||||2.33|0.63|0.57
72591313|NCT01340027|144713810|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.36||||0.36|TWO_SIDED|95.0|0.7|2.66|||Regression, Logistic|||||2.66|0.70|0.36
72591314|NCT01340027|144713810|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.66||||0.15|TWO_SIDED|95.0|0.83|3.32|||Regression, Logistic|||||3.32|0.83|0.15
72591315|NCT01340027|144713810|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.55||||0.31|TWO_SIDED|95.0|0.67|3.59|||Regression, Logistic|||||3.59|0.67|0.31
72591316|NCT01340027|144713810|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.91||||0.81|TWO_SIDED|95.0|0.42|1.95|||Regression, Logistic|||||1.95|0.42|0.81
72591317|NCT01340027|144713810|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.75||||0.19|TWO_SIDED|95.0|0.75|4.08|||Regression, Logistic|||||4.08|0.75|0.19
72414389|NCT01944631|144338039|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.1069||||0.6954|TWO_SIDED|95.0|0.666|1.84|||Regression, Logistic||A value greater than one favours bisolviral|||1.840|0.666|0.6954
72414390|NCT00958919|144338051|SUPERIORITY_OR_OTHER||Mean Difference (Net)|5.0||||0.0004|TWO_SIDED|95.0|2.69|9.38|||t-test, 2 sided|||||9.38|2.69|.0004
72414391|NCT00958919|144338052|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.0||||0.024|TWO_SIDED|95.0|0.49|6.85|||t-test, 2 sided|||||6.85|0.49|.024
72414392|NCT00958919|144338053|SUPERIORITY_OR_OTHER|||||||0.45||95.0|||||t-test, 2 sided|||||||0.45
72591318|NCT01340027|144713810|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.25||||0.59|TWO_SIDED|95.0|0.56|2.77|||Regression, Logistic|||||2.77|0.56|0.59
72591319|NCT01340027|144713810|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.97||||0.13|TWO_SIDED|95.0|0.83|4.71|||Regression, Logistic|||||4.71|0.83|0.13
72591320|NCT01340027|144713810|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.57||||0.2|TWO_SIDED|95.0|0.78|3.16|||Regression, Logistic|||||3.16|0.78|0.20
72414393|NCT00958919|144338054|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||||||<0.001
72591321|NCT01340027|144713810|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.24||||0.07|TWO_SIDED|95.0|0.94|5.34|||Regression, Logistic|||||5.34|0.94|0.070
72591322|NCT01340027|144713810|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.64||||0.17|TWO_SIDED|95.0|0.81|3.33|||Regression, Logistic|||||3.33|0.81|0.17
72414394|NCT00958919|144338055|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||||||<0.001
72414395|NCT01552213|144338056|SUPERIORITY||Risk Ratio (RR)|0.8||||0.32|TWO_SIDED|95.0|0.53|1.24|||Chi-squared|||||1.24|0.53|0.32
72414396|NCT01552213|144338057|SUPERIORITY|||||||0.32|||||||Chi-squared|||||||0.32
72414397|NCT01552213|144338058|SUPERIORITY|||||||0.96|||||||Chi-squared|||||||0.96
72414398|NCT01552213|144338059|SUPERIORITY|||||||0.01|||||||t-test, 2 sided|||||||0.01
72414399|NCT01552213|144338060|SUPERIORITY|||||||0.75|||||||t-test, 2 sided|||||||0.75
72414400|NCT01552213|144338061|SUPERIORITY|||||||0.95|||||||Chi-squared|||||||0.95
72414401|NCT01552213|144338062|SUPERIORITY|||||||0.5|||||||Chi-squared|||||||0.5
72414402|NCT01552213|144338063|SUPERIORITY|||||||0.6|||||||t-test, 2 sided|||||||0.6
72414403|NCT01552213|144338064|SUPERIORITY|||||||0.36|||||||Chi-squared|||||||0.36
72414404|NCT01552213|144338065|SUPERIORITY|||||||0.42|||||||t-test, 2 sided|||||||0.42
72414405|NCT01552213|144338066|SUPERIORITY|||||||0.5|||||||t-test, 2 sided|||||||0.5
72414406|NCT01552213|144338067|SUPERIORITY|||||||0.46|||||||Chi-squared|||||||0.46
72414407|NCT01552213|144338068|SUPERIORITY|||||||1|||||||Chi-squared|||||||1
72414408|NCT01552213|144338069|SUPERIORITY|||||||0.56|||||||Chi-squared|||||||0.56
72414409|NCT04723576|144338071|OTHER|Standard 2-sided non-equivalence test|Mean Difference (Net)|0.189||||0.77|TWO_SIDED|95.0|-1.068|1.446|||Mixed Models Analysis||Effect sizes are the difference between SFA minus Usual Care.|||1.446|-1.068|.77
72591323|NCT01340027|144713810|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.9||||0.084|TWO_SIDED|95.0|0.92|3.92|||Regression, Logistic|||||3.92|0.92|0.084
72591324|NCT01340027|144713810|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.14||||0.043|TWO_SIDED|95.0|1.02|4.48|||Regression, Logistic|||||4.48|1.02|0.043
72591325|NCT01340027|144713810|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.61||||0.013|TWO_SIDED|95.0|1.22|5.58|||Regression, Logistic|||||5.58|1.22|0.013
72591326|NCT01340027|144713810|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.43||||0.053|TWO_SIDED|95.0|0.99|5.97|||Regression, Logistic|||||5.97|0.99|0.053
72591327|NCT01340027|144713810|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.43||||0.39|TWO_SIDED|95.0|0.63|3.26|||Regression, Logistic|||||3.26|0.63|0.39
72591328|NCT01340027|144713811|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|2.9|STANDARD_ERROR_OF_MEAN|2.55||0.26|TWO_SIDED|95.0|-2.1|7.9|||ANCOVA|||"Statistical comparisons were made using 2-sided tests at the 0.05 significance level. No adjustment for multiple testing was performed.~The ANCOVA model for all pairwise comparisons includes the 2 main factors mirabegron dose and solifenacin succinate dose and their interaction, sex, age group and geographic region as fixed factors and baseline measurement as a covariate.~LS Mean Differences were calculated by subtracting Solifenacin 5 mg/Placebo from the comparison treatment group."||7.9|-2.1|0.26
72591329|NCT01340027|144713811|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|1.8|STANDARD_ERROR_OF_MEAN|2.1||0.38|TWO_SIDED|95.0|-2.3|6.0|||ANCOVA|||||6.0|-2.3|0.38
72591330|NCT01340027|144713811|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differrence|4.8|STANDARD_ERROR_OF_MEAN|2.1||0.022|TWO_SIDED|95.0|0.7|8.9|||ANCOVA|||||8.9|0.7|0.022
72591331|NCT01340027|144713811|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|5.5|STANDARD_ERROR_OF_MEAN|2.12||0.01|TWO_SIDED|95.0|1.3|9.7|||ANCOVA|||||9.7|1.3|0.010
72591332|NCT01340027|144713811|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|6.4|STANDARD_ERROR_OF_MEAN|2.09||0.002|TWO_SIDED|95.0|2.3|10.5|||ANCOVA|||||10.5|2.3|0.002
72591333|NCT01340027|144713811|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|6.7|STANDARD_ERROR_OF_MEAN|2.52||0.008|TWO_SIDED|95.0|1.7|11.6|||ANCOVA|||||11.6|1.7|0.008
72591334|NCT01340027|144713811|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|5.3|STANDARD_ERROR_OF_MEAN|2.52||0.037|TWO_SIDED|95.0|0.3|10.2|||ANCOVA|||||10.2|0.3|0.037
72591335|NCT01340027|144713811|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-2.0|STANDARD_ERROR_OF_MEAN|2.9||0.5|TWO_SIDED|95.0|-7.7|3.7|||ANCOVA|||||3.7|-7.7|0.50
72591336|NCT01340027|144713811|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|1.3|STANDARD_ERROR_OF_MEAN|2.89||0.65|TWO_SIDED|95.0|-4.4|7.0|||ANCOVA|||||7.0|-4.4|0.65
72591337|NCT01340027|144713811|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|3.3|STANDARD_ERROR_OF_MEAN|2.88||0.25|TWO_SIDED|95.0|-2.4|8.9|||ANCOVA|||||8.9|-2.4|0.25
72591338|NCT01340027|144713811|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|2.51||0.76|TWO_SIDED|95.0|-5.7|4.1|||ANCOVA|||||4.1|-5.7|0.76
72591339|NCT01340027|144713811|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|2.1|STANDARD_ERROR_OF_MEAN|2.91||0.47|TWO_SIDED|95.0|-3.6|7.8|||ANCOVA|||||7.8|-3.6|0.47
72591340|NCT01340027|144713811|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|1.1|STANDARD_ERROR_OF_MEAN|2.52||0.67|TWO_SIDED|95.0|-3.9|6.0|||ANCOVA|||||6.0|-3.9|0.67
72591341|NCT01340027|144713811|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|4.0|STANDARD_ERROR_OF_MEAN|2.52||0.11|TWO_SIDED|95.0|-0.9|9.0|||ANCOVA|||||9.0|-0.9|0.11
72591342|NCT01340027|144713811|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|4.7|STANDARD_ERROR_OF_MEAN|2.54||0.062|TWO_SIDED|95.0|-0.2|9.7|||ANCOVA|||||9.7|-0.2|0.062
72591343|NCT01340027|144713811|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|5.6|STANDARD_ERROR_OF_MEAN|2.52||0.025|TWO_SIDED|95.0|0.7|10.6|||ANCOVA|||||10.6|0.7|0.025
72591344|NCT01340027|144713811|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|5.9|STANDARD_ERROR_OF_MEAN|2.88||0.041|TWO_SIDED|95.0|0.2|11.5|||ANCOVA|||||11.5|0.2|0.041
72591345|NCT01340027|144713811|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|4.5|STANDARD_ERROR_OF_MEAN|2.88||0.12|TWO_SIDED|95.0|-1.2|10.1|||ANCOVA|||||10.1|-1.2|0.12
72591346|NCT01340027|144713812|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.04||||0.92|TWO_SIDED|95.0|0.52|2.08|||Regression, Logistic|||"All statistical comparisons were made using 2-sided tests at the 0.05 significance level. No adjustment for multiple testing was performed.~The logistic regression model includes the 2 main factors mirabegron dose and solifenacin dose and their interaction, sex, age group and geographic region as fixed factors and baseline measurement as a covariate."||2.08|0.52|0.92
72591347|NCT01340027|144713812|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.01||||0.98|TWO_SIDED|95.0|0.58|1.77|||Regression, Logistic|||||1.77|0.58|0.98
72591348|NCT01340027|144713812|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.25||||0.45|TWO_SIDED|95.0|0.7|2.23|||Regression, Logistic|||||2.23|0.70|0.45
72591349|NCT01340027|144713812|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.41||||0.24|TWO_SIDED|95.0|0.79|2.53|||Regression, Logistic|||||2.53|0.79|0.24
72591350|NCT01340027|144713812|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.21||||0.012|TWO_SIDED|95.0|1.19|4.09|||Regression, Logistic|||||4.09|1.19|0.012
72591351|NCT01340027|144713812|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.43||||0.32|TWO_SIDED|95.0|0.7|2.9|||Regression, Logistic|||||2.90|0.70|0.32
72591352|NCT01340027|144713812|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.51||||0.27|TWO_SIDED|95.0|0.72|3.14|||Regression, Logistic|||||3.14|0.72|0.27
72591353|NCT01340027|144713812|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.5||||0.064|TWO_SIDED|95.0|0.24|1.04|||Regression, Logistic|||||1.04|0.24|0.064
72591354|NCT01340027|144713812|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.24||||0.57|TWO_SIDED|95.0|0.59|2.61|||Regression, Logistic|||||2.61|0.59|0.57
72591355|NCT01340027|144713812|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.26||||0.55|TWO_SIDED|95.0|0.59|2.68|||Regression, Logistic|||||2.68|0.59|0.55
72591356|NCT01340027|144713812|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.11||||0.75|TWO_SIDED|95.0|0.58|2.13|||Regression, Logistic|||||2.13|0.58|0.75
72591357|NCT01340027|144713812|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.15||||0.72|TWO_SIDED|95.0|0.53|2.49|||Regression, Logistic|||||2.49|0.53|0.72
72591358|NCT01340027|144713812|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.12||||0.74|TWO_SIDED|95.0|0.58|2.15|||Regression, Logistic|||||2.15|0.58|0.74
72591359|NCT01340027|144713812|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.39||||0.34|TWO_SIDED|95.0|0.71|2.71|||Regression, Logistic|||||2.71|0.71|0.34
72591360|NCT01340027|144713812|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.57||||0.19|TWO_SIDED|95.0|0.8|3.07|||Regression, Logistic|||||3.07|0.80|0.19
72591361|NCT01340027|144713812|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.45||||0.012|TWO_SIDED|95.0|1.22|4.94|||Regression, Logistic|||||4.94|1.22|0.012
72591362|NCT01340027|144713812|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.59||||0.25|TWO_SIDED|95.0|0.72|3.47|||Regression, Logistic|||||3.47|0.72|0.25
72591363|NCT01340027|144713812|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.67||||0.21|TWO_SIDED|95.0|0.74|3.75|||Regression, Logistic|||||3.75|0.74|0.21
72414410|NCT04723576|144338072|OTHER|Standard 2-sided non-equivalence test|Median Difference (Net)|0.238||||0.39|TWO_SIDED|95.0|-0.31|0.785|||Mixed Models Analysis||Effect sizes are the difference between SFA minus Usual Care.|||0.785|-0.310|.39
72414411|NCT04723576|144338073|OTHER|Standard 2-sided non-equivalence test|Mean Difference (Net)|-0.232||||0.24|TWO_SIDED|95.0|-0.618|0.153|||Mixed Models Analysis||Effect sizes are the difference between SFA minus Usual Care.|||0.153|-0.618|.24
72414412|NCT04723576|144338074|OTHER|Standard 2-sided non-equivalence test|Median Difference (Net)|0.134||||0.23|TWO_SIDED|95.0|-0.085|0.352|||Mixed Models Analysis||Effect sizes are the difference between SFA minus Usual Care.|||0.352|-0.085|.23
72414413|NCT04723576|144338075|OTHER|Standard 2-sided non-equivalence test|Median Difference (Net)|-0.051||||0.44|TWO_SIDED|95.0|-0.179|0.078|||Mixed Models Analysis||Effect sizes are the difference between SFA minus Usual Care.|||0.078|-0.179|.44
72414414|NCT04723576|144338076|OTHER|Standard 2-sided non-equivalence test|Odds Ratio, log|-0.051||||0.85|TWO_SIDED|95.0|-0.179|0.078|||Repeated measure logistic regression|using GEE method|Effect sizes are the difference between SFA minus Usual Care.|||0.078|-0.179|.85
72591364|NCT01340027|144713820|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.18|STANDARD_ERROR_OF_MEAN|0.376||0.63|TWO_SIDED|95.0|-0.56|0.92|||ANCOVA|||"Statistical comparisons were made using 2-sided tests at the 0.05 significance level. No adjustment for multiple testing was performed.~The ANCOVA model for all pairwise comparisons includes the 2 main factors mirabegron dose and solifenacin succinate dose and their interaction, sex, age group and geographic region as fixed factors and baseline measurement as a covariate.~LS Mean Differences were calculated by subtracting Solifenacin 5 mg/Placebo from the comparison treatment group."||0.92|-0.56|0.63
72591365|NCT01340027|144713820|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.18|STANDARD_ERROR_OF_MEAN|0.31||0.56|TWO_SIDED|95.0|-0.43|0.79|||ANCOVA|||||0.79|-0.43|0.56
72591366|NCT01340027|144713820|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.46|STANDARD_ERROR_OF_MEAN|0.308||0.14|TWO_SIDED|95.0|-0.15|1.06|||ANCOVA|||||1.06|-0.15|0.14
72591367|NCT01340027|144713820|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.69|STANDARD_ERROR_OF_MEAN|0.313||0.027|TWO_SIDED|95.0|0.08|1.3|||ANCOVA|||||1.30|0.08|0.027
72591368|NCT01340027|144713820|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.46|STANDARD_ERROR_OF_MEAN|0.308||0.13|TWO_SIDED|95.0|-0.14|1.07|||ANCOVA|||||1.07|-0.14|0.13
72591369|NCT01340027|144713820|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.73|STANDARD_ERROR_OF_MEAN|0.371||0.049|TWO_SIDED|95.0|0.0|1.46|||ANCOVA|||||1.46|0.00|0.049
72414415|NCT04723576|144338077|OTHER|Standard 2-sided non-equivalence test|Median Difference (Net)|0.23||||0.08|TWO_SIDED|95.0|-0.025|0.484|||Mixed Models Analysis||Effect sizes are the difference between SFA minus Usual Care|||0.484|-0.025|.08
72591370|NCT01340027|144713820|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.94|STANDARD_ERROR_OF_MEAN|0.368||0.011|TWO_SIDED|95.0|0.22|1.66|||ANCOVA|||||1.66|0.22|0.011
72591371|NCT01340027|144713820|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.17|STANDARD_ERROR_OF_MEAN|0.428||0.7|TWO_SIDED|95.0|-0.67|1.01|||ANCOVA|||||1.01|-0.67|0.70
72591372|NCT01340027|144713820|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.73|STANDARD_ERROR_OF_MEAN|0.423||0.084|TWO_SIDED|95.0|-0.1|1.56|||ANCOVA|||||1.56|-0.10|0.084
72414416|NCT02119416|144338136|OTHER|Maximum heart rate after 2 mg/kg of caffeine compared to baseline was assessed using a mixed effects regression model. Sex and pubertal stage were included in the model as time invariant predictors.|||||<|0.05||||||The p-value was not adjusted for multiple comparisons.|mixed effects regression|||||||<0.05
72414417|NCT02119416|144338136|OTHER|We compared means of our dependent variables after administration of different doses of caffeine.|||||<|0.05||||||The p-value was set prior to the analysis and all comparisons were planned.|ANCOVA|||We used repeated measures ANOVAS and conducted planned comparisons between groups as post-hoc tests.||||< 0.05
72414418|NCT02119416|144338137|OTHER|mixed effects regression models were used with sex and pubertal stage as time invariant predictors.|||||<|0.05|||||||mixed effects regression|||order was included in the analysis. We examined caffeine dose.||||<0.05
72414419|NCT02119416|144338137|OTHER||||||<|0.05|||||||Mixed Models Analysis|||||||<0.05
72591373|NCT01340027|144713820|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.66|STANDARD_ERROR_OF_MEAN|0.425||0.12|TWO_SIDED|95.0|-0.18|1.49|||ANCOVA|||||1.49|-0.18|0.12
72591374|NCT01340027|144713820|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.34|STANDARD_ERROR_OF_MEAN|0.369||0.36|TWO_SIDED|95.0|-0.39|1.06|||ANCOVA|||||1.06|-0.39|0.36
72591375|NCT01340027|144713820|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.52|STANDARD_ERROR_OF_MEAN|0.428||0.23|TWO_SIDED|95.0|-0.32|1.36|||ANCOVA|||||1.36|-0.32|0.23
72591376|NCT01340027|144713820|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.52|STANDARD_ERROR_OF_MEAN|0.371||0.16|TWO_SIDED|95.0|-0.21|1.25|||ANCOVA|||||1.25|-0.21|0.16
72591377|NCT01340027|144713820|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.79|STANDARD_ERROR_OF_MEAN|0.371||0.032|TWO_SIDED|95.0|0.07|1.52|||ANCOVA|||||1.52|0.07|0.032
72591378|NCT01340027|144713820|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|1.03|STANDARD_ERROR_OF_MEAN|0.373||0.006|TWO_SIDED|95.0|0.3|1.76|||ANCOVA|||||1.76|0.30|0.006
72591379|NCT01340027|144713820|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.8|STANDARD_ERROR_OF_MEAN|0.369||0.031|TWO_SIDED|95.0|0.07|1.52|||ANCOVA|||||1.52|0.07|0.031
72591380|NCT01340027|144713820|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|1.07|STANDARD_ERROR_OF_MEAN|0.423||0.012|TWO_SIDED|95.0|0.24|1.9|||ANCOVA|||||1.90|0.24|0.012
72591381|NCT01340027|144713820|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|1.28|STANDARD_ERROR_OF_MEAN|0.421||0.002|TWO_SIDED|95.0|0.45|2.1|||ANCOVA|||||2.10|0.45|0.002
72591382|NCT04687072|144713821|SUPERIORITY||Difference in percentage|-3.5||||0.5081|TWO_SIDED|95.0|-14.7|7.0||The p-value was calculated using the Cochran-Mantel-Haenszel test used in the hierarchical testing procedure.|Cochran-Mantel-Haenszel||The adjusted difference in percentages and 95% confidence interval (CI) (Klingenberg approach) were presented.|||7.0|-14.7|0.5081
72591383|NCT04687072|144713822|SUPERIORITY||Location shift|0.0||||0.4925|TWO_SIDED|95.0|0.0|0.0||The p-value was calculated using the stratified Mann-Whitney test used in the hierarchical testing procedure.|Wilcoxon (Mann-Whitney)||The Hodges-Lehmann estimator of the treatment difference and 95% CI are presented.|||0.000|0.000|0.4925
72591384|NCT04687072|144713823|SUPERIORITY||Difference in percentage|-0.5||||0.9314|TWO_SIDED|95.0|-11.7|10.0||The p-value was calculated using the Cochran-Mantel-Haenszel test used in the hierarchical testing procedure.|Cochran-Mantel-Haenszel||The adjusted difference in percentages and 95% CI (Klingenberg approach) were presented.|||10.0|-11.7|0.9314
72591385|NCT04687072|144713824|SUPERIORITY||Difference in percentage|-1.7||||0.7379|TWO_SIDED|95.0|-12.4|8.2||The Cochran-Mantel-Haenszel test p-value was used in the hierarchical testing procedure.|Cochran-Mantel-Haenszel||The adjusted difference in percentage and 95% CI (Klingenberg approach) are presented.|||8.2|-12.4|0.7379
72591386|NCT04687072|144713825|OTHER||Difference in percentage|4.2|||||TWO_SIDED|95.0|-9.3|16.8|||||||The 95% Agresti-Min CIs are presented.|16.8|-9.3|
72591387|NCT04687072|144713826|SUPERIORITY||Location shift|0.0||||0.726|TWO_SIDED|95.0|0.0|0.0||The p-value was calculated using the stratified Mann-Whitney test.|Wilcoxon (Mann-Whitney)||The Hodges-Lehmann estimator of the treatment difference and 95% CI are presented.|||0.000|0.000|0.7260
72591388|NCT04687072|144713827|OTHER||Difference in percentage|2.5|||||TWO_SIDED|95.0|-9.6|13.0|||||The 95% Agresti-Min CIs are presented.|||13.0|-9.6|
72591389|NCT04687072|144713830|SUPERIORITY||Location shift|0.0||||0.2929|TWO_SIDED|95.0|0.0|1.0||The p-value was calculated using the stratified Mann-Whitney test.|Wilcoxon (Mann-Whitney)||The Hodges-Lehmann estimator of the treatment difference and 95% CI are presented.|||1.000|0.000|0.2929
72591390|NCT04687072|144713831|SUPERIORITY||Location shift|0.0||||0.1475|TWO_SIDED|95.0|0.0|1.0||The p-value was calculated using the stratified Mann-Whitney test.|Wilcoxon (Mann-Whitney)||The Hodges-Lehmann estimator of the treatment difference and 95% CI are presented.|||1.000|0.000|0.1475
72591391|NCT04687072|144713832|SUPERIORITY||Location shift|0.0||||0.7677|TWO_SIDED|95.0|-2.0|2.0||The p-value was calculated using the stratified Mann-Whitney test used in the hierarchical testing procedure.|Wilcoxon (Mann-Whitney)||The Hodges-Lehmann estimator of the treatment difference and 95% CI are presented.|WHO Classified Bleeding Event Grade ≥1||2.000|-2.000|0.7677
72591392|NCT04687072|144713833|OTHER||Difference in percentage|-1.2|||||TWO_SIDED|95.0|-11.8|7.3|||||The 95% Agresti-Min CIs are presented.|IWG Complete Response||7.3|-11.8|
72591393|NCT04687072|144713833|OTHER||Difference in percentage|8.5|||||TWO_SIDED|95.0|-4.6|20.2|||||The 95% Agresti-Min CIs are presented.|IWG Response||20.2|-4.6|
72591394|NCT04687072|144713833|OTHER||Difference in percentage|2.6|||||TWO_SIDED|95.0|-9.7|13.3|||||The 95% Agresti-Min CIs are presented.|Initial Response||13.3|-9.7|
72591395|NCT04687072|144713835|OTHER||Difference in percentage|-4.0|||||TWO_SIDED|95.0|-15.6|5.7|||||The 95% Agresti-Min CIs are presented.|||5.7|-15.6|
72591396|NCT01662791|144713852|SUPERIORITY_OR_OTHER|||||||1|||||||Chi-squared|||Comparison between the groups for \>12 ppm.||||1.0
72591397|NCT01662791|144713853|SUPERIORITY_OR_OTHER|||||||0.235|||||||Chi-squared|||Comparison between groups for mobility sub-scale.||||0.235
72591398|NCT01662791|144713853|SUPERIORITY_OR_OTHER|||||||0.206|||||||Chi-squared|||Comparison between groups for activities of daily living sub-scale.||||0.206
72591399|NCT01662791|144713853|SUPERIORITY_OR_OTHER|||||||0.641|||||||Chi-squared|||Comparison between groups for emotional well-being sub-scale.||||0.641
72591400|NCT01662791|144713853|SUPERIORITY_OR_OTHER|||||||0.446|||||||Chi-squared|||Comparison between groups for stigma sub-scale.||||0.446
72591401|NCT01662791|144713853|SUPERIORITY_OR_OTHER|||||||0.466|||||||Chi-squared|||Comparison between groups for social support sub-scale.||||0.466
72591402|NCT01662791|144713853|SUPERIORITY_OR_OTHER|||||||0.205|||||||Chi-squared|||Comparison between groups for cognition sub-scale.||||0.205
72591403|NCT01662791|144713853|SUPERIORITY_OR_OTHER|||||||0.153|||||||Chi-squared|||Comparison between groups for communication sub-scale.||||0.153
72591404|NCT01662791|144713853|SUPERIORITY_OR_OTHER|||||||0.73|||||||Chi-squared|||Comparison between groups for bodily discomfort sub-scale.||||0.730
72591405|NCT01662791|144713853|SUPERIORITY_OR_OTHER|||||||0.334|||||||Chi-squared|||Comparison between groups for summary index sub-scale.||||0.334
72591406|NCT01662791|144713854|SUPERIORITY_OR_OTHER|||||||0.167|||||||McNemar|||Comparison in case group between baseline and 3 months for mobility sub-scale.||||0.167
72591407|NCT01662791|144713854|SUPERIORITY_OR_OTHER|||||||0.159|||||||McNemar|||Comparison in case group between baseline and 3 months for activities of daily living sub-scale.||||0.159
72591408|NCT01662791|144713854|SUPERIORITY_OR_OTHER|||||||0.041|||||||McNemar|||Comparison in case group between baseline and 3 months for emotional well-being sub-scale.||||0.041
72591409|NCT01662791|144713854|SUPERIORITY_OR_OTHER|||||||0.19|||||||McNemar|||Comparison in case group between baseline and 3 months for stigma sub-scale.||||0.190
72591410|NCT01662791|144713854|SUPERIORITY_OR_OTHER|||||||1|||||||McNemar|||Comparison in case group between baseline and 3 months for social support sub-scale.||||1.0
72591411|NCT01662791|144713854|SUPERIORITY_OR_OTHER|||||||0.16|||||||McNemar|||Comparison in case group between baseline and 3 months for cognition sub-scale.||||0.160
72591412|NCT01662791|144713854|SUPERIORITY_OR_OTHER|||||||0.276|||||||McNemar|||Comparison in case group between baseline and 3 months for communication sub-scale.||||0.276
72591413|NCT01662791|144713854|SUPERIORITY_OR_OTHER|||||||0.351|||||||McNemar|||Comparison in case group between baseline and 3 months for bodily discomfort sub-scale.||||0.351
72591414|NCT01662791|144713854|SUPERIORITY_OR_OTHER|||||||0.186|||||||McNemar|||Comparison in case group between baseline and 3 months for summary index sub-scale.||||0.186
72591415|NCT01662791|144713855|SUPERIORITY_OR_OTHER|||||||0.303|||||||Chi-squared|||Comparison between groups for constipation sub-scale.||||0.303
72591416|NCT01662791|144713855|SUPERIORITY_OR_OTHER|||||||0.518|||||||Chi-squared|||Comparison between groups for dyspepsia sub-scale.||||0.518
72591417|NCT01662791|144713855|SUPERIORITY_OR_OTHER|||||||0.8|||||||Chi-squared|||Comparison between groups for abdominal discomfort sub-scale.||||0.800
72591418|NCT01662791|144713855|SUPERIORITY_OR_OTHER|||||||0.736|||||||Chi-squared|||Comparison between groups for diarrhea sub-scale.||||0.736
72591419|NCT01662791|144713855|SUPERIORITY_OR_OTHER|||||||0.57|||||||Chi-squared|||Comparison between groups for GERD sub-scale.||||0.570
72591420|NCT01662791|144713855|SUPERIORITY_OR_OTHER|||||||0.394|||||||Chi-squared|||Comparison between groups for nausea and vomiting sub-scale.||||0.394
72591421|NCT01662791|144713856|SUPERIORITY_OR_OTHER|||||||0.056|||||||McNemar|||Comparison in case group between baseline and 3 months for constipation sub-scale.||||0.056
72591422|NCT01662791|144713856|SUPERIORITY_OR_OTHER|||||||0.38|||||||McNemar|||Comparison in case group between baseline and 3 months for dyspepsia sub-scale.||||0.380
72591423|NCT01662791|144713856|SUPERIORITY_OR_OTHER|||||||0.244|||||||McNemar|||Comparison in case group between baseline and 3 months for abdominal discomfort sub-scale.||||0.244
72591424|NCT01662791|144713856|SUPERIORITY_OR_OTHER|||||||0.279|||||||McNemar|||Comparison in case group between baseline and 3 months for diarrhea sub-scale.||||0.279
72591425|NCT01662791|144713856|SUPERIORITY_OR_OTHER|||||||0.554|||||||McNemar|||Comparison in case group between baseline and 3 months for GERD sub-scale.||||0.554
72591426|NCT01662791|144713856|SUPERIORITY_OR_OTHER|||||||0.351|||||||McNemar|||Comparison in case group between baseline and 3 months for nausea and vomiting sub-scale.||||0.351
72591427|NCT01662791|144713857|SUPERIORITY_OR_OTHER|||||||0.872|TWO_SIDED||||||t-test, 1 sided|||Comparison between the two groups at baseline for depression||||0.872
72591428|NCT01662791|144713857|SUPERIORITY_OR_OTHER|||||||0.835|TWO_SIDED||||||t-test, 1 sided|||Comparison between the two groups at baseline for anxiety.||||0.835
72591429|NCT02396420|144713861|OTHER||||||||||||||||||Statistical analysis was not performed as the sample size is insufficient to have confidence that the results would be meaningful for the overall target population.|||
72591430|NCT02396420|144713862|OTHER||||||||||||||||||Statistical analysis was not performed as the sample size is insufficient to have confidence that the results would be meaningful for the overall target population.|||
72591431|NCT02396420|144713863|OTHER||||||||||||||||||Statistical analysis was not performed as the sample size is insufficient to have confidence that the results would be meaningful for the overall target population.|||
72591432|NCT02396420|144713864|OTHER|Statistical analysis was not performed as this data was not available for any subjects in the analysis population.||||||||||||||||Statistical analysis was not performed as this data was not available for any subjects in the analysis population.|Statistical analysis was not performed as this data was not available for any subjects in the analysis population.|||
72591433|NCT02396420|144713865|OTHER|Statistical analysis was not performed as this data was not available for any subjects in the analysis population.||||||||||||||||Statistical analysis was not performed as this data was not available for any subjects in the analysis population.|Statistical analysis was not performed as this data was not available for any subjects in the analysis population.|||
72591434|NCT02396420|144713866|OTHER||||||||||||||||||Statistical analysis was not performed as the sample size is insufficient to have confidence that the results would be meaningful for the overall target population.|||
72591435|NCT02396420|144713867|OTHER||||||||||||||||||Statistical analysis was not performed as the sample size is insufficient to have confidence that the results would be meaningful for the overall target population.|||
72591436|NCT02396420|144713868|OTHER||||||||||||||||||Statistical analysis was not performed as the sample size is insufficient to have confidence that the results would be meaningful for the overall target population.|||
72591437|NCT02396420|144713869|OTHER||||||||||||||||||Statistical analysis was not performed as the sample size is insufficient to have confidence that the results would be meaningful for the overall target population.|||
72591438|NCT02396420|144713870|OTHER||||||||||||||||||Statistical analysis was not performed as the sample size is insufficient to have confidence that the results would be meaningful for the overall target population.|||
72591439|NCT02396420|144713871|OTHER||||||||||||||||||Statistical analysis was not performed as the sample size is insufficient to have confidence that the results would be meaningful for the overall target population.|||
72591440|NCT02396420|144713872|OTHER||||||||||||||||||Statistical analysis was not performed as the sample size is insufficient to have confidence that the results would be meaningful for the overall target population.|||
72591441|NCT02396420|144713873|OTHER||||||||||||||||||Statistical analysis was not performed as the sample size is insufficient to have confidence that the results would be meaningful for the overall target population.|||
72591442|NCT02396420|144713874|OTHER||||||||||||||||||Statistical analysis was not performed as the sample size is insufficient to have confidence that the results would be meaningful for the overall target population.|||
72591443|NCT02396420|144713875|OTHER||||||||||||||||||Statistical analysis was not performed as the sample size is insufficient to have confidence that the results would be meaningful for the overall target population.|||
72591444|NCT02396420|144713876|OTHER||||||||||||||||||Statistical analysis was not performed as the sample size is insufficient to have confidence that the results would be meaningful for the overall target population.|||
72591445|NCT02396420|144713877|OTHER||||||||||||||||||Statistical analysis was not performed as the sample size is insufficient to have confidence that the results would be meaningful for the overall target population.|||
72591446|NCT01273623|144713878|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
72591447|NCT00519428|144713881|SUPERIORITY|Hypothesis: Dual Treatment (escitalopram + bupropion) will result in greater improvement over 12 weeks than either monotherapy (i.e., two analyses: 1) dual treatment will outperform escitalopram monotherapy; 2) dual treatment will outperform bupropion monotherapy).|Mean Difference (Final Values)|0.05|STANDARD_DEVIATION|4.0||0.05|TWO_SIDED|||||"Each individual test will require the calculated p to be \< .0916 to declare that comparison to be significant. Since the hypothesis requires both comparisons to be significant, this produces an over-all alpha of .05."|Cochran-Mantel-Haenszel|||Hypothesis: Dual Treatment (escitalopram + bupropion) will result in greater improvement over 12 weeks than either monotherapy (i.e., two analyses: 1) dual treatment will outperform escitalopram monotherapy; 2) dual treatment will outperform bupropion monotherapy). Therefore each analysis will be done twice and it will be required that both analyses be significant to declare the over-all study significant.||||.05
72591448|NCT00519428|144713883|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.0|STANDARD_DEVIATION|8.0||0.0916|TWO_SIDED|95.0||||escitalopram + bupropion vs. escitalopram: F(1,159) = 1.93, ns escitalopram + bupropion vs. bupropion: F (1,157) = 1.99, ns|ANCOVA|adjusting for baseline score and country||To test the hypothesis that escitalopram + bupropion would have superior efficacy relative to each monotherapy, the group receiving both medications was separately compared to each monotherapy group, covarying for baseline score and country||||.0916
72591449|NCT04064411|144713886|NON_INFERIORITY|"Noninferiority margin = 2.0% for abaloparatide-sMTS compared with abaloparatide-SC.~Non-inferiority was to be concluded if the lower bound of the 2-sided 95% confidence interval (CI) for the estimated treatment difference (abaloparatide-sMTS minus abaloparatide-SC) in the percent change from baseline in lumbar spine BMD at 12 months was above -2.0% using a Mixed Model for Repeated Measures (MMRM) analysis."|Least Squares Means (LSM) Difference|-3.721|||||TWO_SIDED|95.0|-5.0089|-2.4331|||||LSM Difference = abaloparatide-sMTS minus abaloparatide-SC|||-2.4331|-5.0089|
72591450|NCT03053063|144713903|SUPERIORITY||Percentage Difference|1.9||||0.5572|TWO_SIDED|95.0|-4.4|8.2||Difference between SEL 18 mg vs Placebo, 95% confidence interval (CI) and p-value were obtained by stratified Mantel-Haenszel method adjusting for baseline (BL) diabetes mellitus status and BL Enhanced Liver Fibrosis (ELF) score (\<11.27 vs ≥11.27).|Mantel Haenszel|||||8.2|-4.4|0.5572
72591451|NCT03053063|144713903|SUPERIORITY||Percentage Difference|0.3||||0.9272|TWO_SIDED|95.0|-6.0|6.5||Difference between SEL 6 mg vs Placebo, 95% CI and p-value were obtained by stratified Mantel-Haenszel method adjusting for BL diabetes mellitus status and BL ELF score (\<11.27 vs ≥11.27).|Mantel Haenszel|||||6.5|-6.0|0.9272
72591452|NCT03053063|144713906|SUPERIORITY||Percentage Difference|3.8||||0.285|TWO_SIDED|95.0|-3.1|10.6||Difference between SEL 18 mg vs Placebo, 95% CI and p-value were obtained by stratified Mantel-Haenszel method adjusting for BL diabetes mellitus status and BL ELF score (\<11.27 vs ≥11.27).|Mantel Haenszel|||||10.6|-3.1|0.2850
72591453|NCT03053063|144713906|SUPERIORITY||Percentage Difference|1.5||||0.6731|TWO_SIDED|95.0|-5.3|8.2||Difference between SEL 6 mg vs Placebo, 95% CI and p-value were obtained by stratified Mantel-Haenszel method adjusting for BL diabetes mellitus status and BL ELF score (\<11.27 vs ≥11.27).|Mantel Haenszel|||||8.2|-5.3|0.6731
72591454|NCT03053063|144713908|SUPERIORITY||Percentage Difference|-1.7||||0.365|TWO_SIDED|95.0|-5.5|2.0||Difference between SEL 18 mg vs Placebo, 95% CI and p-value were obtained by stratified Mantel-Haenszel method adjusting for BL diabetes mellitus status and BL ELF score (\<11.27 vs ≥11.27).|Mantel Haenszel|||||2.0|-5.5|0.3650
72591455|NCT03053063|144713908|SUPERIORITY||Percentage Difference|-0.4||||0.8557|TWO_SIDED|95.0|-4.3|3.6||Difference between SEL 6 mg vs Placebo, 95% CI and p-value were obtained by stratified Mantel-Haenszel method adjusting for BL diabetes mellitus status and BL ELF score (\<11.27 vs ≥11.27).|Mantel Haenszel|||||3.6|-4.3|0.8557
72591456|NCT01970475|144713914|NON_INFERIORITY_OR_EQUIVALENCE|The hypothesis was tested by comparing the 2-sided 90% confidence interval (CI) of the RR of ACR20 at week 24 between ABP 501 and adalimumab with an equivalence margin of (0.738, 1/0.738).|Risk Ratio (RR)|1.039|||||TWO_SIDED|90.0|0.954|1.133|||||Based on a generalized linear model adjusted for geographic region and prior biological use for RA as covariates in the model.|The study hypothesis was that there were no clinically meaningful differences between ABP 501 and adalimumab in risk ratio (RR) of ACR20 at week 24.||1.133|0.954|
72591457|NCT05129293|144713928|SUPERIORITY|||||||0.229|||||||ANCOVA|Adjusted for disease duration, SymptoMScreen depression and anxiety scores, and Test of Everyday Cognition baseline performance||||||0.229
72591458|NCT05129293|144713929|SUPERIORITY|||||||0.04|||||||ANCOVA|Adjusted for disease duration, SymptoMScreen depression and anxiety scores, and Test of Everyday Cognition baseline performance||||||0.040
72591459|NCT05129293|144713930|SUPERIORITY|||||||0.266|||||||ANCOVA|Adjusted for disease duration, SymptoMScreen depression and anxiety scores, and Test of Everyday Cognition baseline performance||||||0.266
72591460|NCT00908791|144713931|SUPERIORITY_OR_OTHER|||||||0.003|||||||McNemar|exact McNemar test for paired binary data.||||||0.003
72591461|NCT00908791|144713932|SUPERIORITY_OR_OTHER|||||||0.41|||||||McNemar|||||||0.41
72591462|NCT00908791|144713933|SUPERIORITY_OR_OTHER|||||||0.48|TWO_SIDED|95.0|||||bowker's test of symmetry|||||||0.48
72591463|NCT00908791|144713934|SUPERIORITY_OR_OTHER|||||||0.029|TWO_SIDED|95.0|||||Sign test|||The Sign-Rank test for paired data.||||0.029
72414420|NCT03593655|144338153|SUPERIORITY||incidence rate ratio|1.01||||0.92|TWO_SIDED|95.0|0.9|1.12||the a priori threshold for statistical significance was \<0.05|generalized estimating equation|Poisson (log) link, adjusted for period, offset of number of visits per period, exchangeable correlation structure, and robust errors.|The incidence rate ratio compares FTC/TDF to the dapivirine vaginal ring.|Comparison of the proportion of participants experiencing a grade 2 adverse event between products, with a null hypothesis of no difference.||1.12|0.90|0.92
72591464|NCT00908791|144713935|SUPERIORITY_OR_OTHER|||||||0.62|||||||t-test, 2 sided|||||||0.62
72591465|NCT00908791|144713936|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|95.0|||||Other|||||||>0.05
72591466|NCT00908791|144713937|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|95.0|||||Other|||||||>0.05
72591467|NCT03192995|144713939|SUPERIORITY|||||||0.91|||||||Fisher Exact|||||||0.91
72591468|NCT03192995|144713940|SUPERIORITY|||||||0.53|||||||Fisher Exact|||||||0.53
72591469|NCT03192995|144713941|SUPERIORITY|||||||0.32|||||||Fisher Exact|||||||.32
72591470|NCT03192995|144713942|SUPERIORITY|||||||0.541|||||||Fisher Exact|||||||.541
72591471|NCT03192995|144713943|SUPERIORITY||Risk Ratio (RR)|0.96|||||TWO_SIDED|95.0|0.24|3.82||||||||3.82|0.24|
72591472|NCT02579343|144713955|SUPERIORITY|||||||0.05||||||P-value above was calculated. Does not reference threshold for clinical significance.|Repeated Measures Analysis of Variance|||||||.05
72591473|NCT02579343|144713956|SUPERIORITY|||||||0.05|||||||Repeated Measures Analysis of Variance|||||||.05
72591474|NCT05027048|144713980|SUPERIORITY||Mean Difference (Net)|211.0|||<|0.05|TWO_SIDED|95.0|-33.0|410.0||a priori threshold for statistical significance p\<0.05|inverse Gaussian distribution and log li|Inverse Gaussian distribution and log link fit to estimate the effect size and 95% CIs|Inverse gaussian regression with a log link was used to calculate the mean reduction in blood loss in the calcium group relative to placebo group.|||410|-33|<0.05
72591475|NCT05027048|144713981|SUPERIORITY||Risk Ratio (RR)|0.71|||||TWO_SIDED|95.0|0.48|1.03|||Regression (poisson with robust SE)|||||1.03|0.48|
72591476|NCT05027048|144713982|SUPERIORITY||Risk Ratio (RR)|0.75|||||TWO_SIDED|95.0|0.46|1.23|||Poisson regression with robust SE|||||1.23|0.46|
72591477|NCT05027048|144713983|SUPERIORITY||Risk Ratio (RR)|0.56|||||TWO_SIDED|95.0|0.2|1.56||||||||1.56|0.2|
72591478|NCT05027048|144713984|SUPERIORITY||Mean Difference (Final Values)|-2.0|||||TWO_SIDED|95.0|-3.6|0.2|||Regression, Linear|Data were log transformed to approximate a normal distribution prior to linear regression.||||0.2|-3.6|
72591479|NCT05027048|144713986|SUPERIORITY|||||||0.415|||||||Wilcoxon (Mann-Whitney)|||||||0.415
72591480|NCT05027048|144713987|SUPERIORITY|||||||0.566|||||||Wilcoxon (Mann-Whitney)|||||||0.566
72591481|NCT05027048|144713989|SUPERIORITY|||||||0.348|||||||ANOVA|||Repeated measures ANOVA used to analyze differences between groups.||||0.348
72591482|NCT05027048|144713990|SUPERIORITY|||||||0.011|||||||ANOVA|Repeated measures ANOVA.||Repeated measures ANOVA used to assess for difference between groups in the % change from baseline heart rate.||||0.011
72591483|NCT05027048|144713992|SUPERIORITY|||||||0.25|||||||t-test, 2 sided|||||||0.25
72591484|NCT05027048|144713993|OTHER||||||||||||||||||"Note: a two-compartment pharmacokinetic model was generated in NONMEM using 6 venous blood ionized calcium measurements per participant at random times. The change in ionized calcium was defined as a measured value minus the measured baseline for the patient.~Once the two-compartment pharmacokinetic model was generated, NONMEM was used to generate a predicted ionized calcium concentration at 10 minutes (Tmax) for each participant to generate mean and 95% confidence interval."|||
72591485|NCT05027048|144713995|SUPERIORITY||Mean Difference (Net)|356.0|||<|0.05|TWO_SIDED|95.0|159.0|515.0|||Inverse Gaussian regression, log link||Reduction in blood loss was calculated by inverse Gaussian regression with a log link as detailed in the description of statistical methods for the primary outcome.|||515|159|<0.05
72591486|NCT01871402|144714019|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||"Treatment groups were compared with respect to the proportions of subjects with treatment success at Day 15 using the Cochran-Mantel-Haenszel (CMH) test stratified by analysis center."|Cochran-Mantel-Haenszel|Multiple imputation was used to impute missing data from the ITT population.||||||<0.001
72591487|NCT01871402|144714020|SUPERIORITY_OR_OTHER||||||<|0.001||||||Statistical significance (\<0.001) was achieved for each of the clinical signs of psoriasis (scaling, erythema, and plaque elevation).|Cochran-Mantel-Haenszel|Missing data was imputed as treatment failure.||Treatment groups were compared with respect to each of the clinical signs of psoriasis (scaling, erythema, and plaque elevation).||||<0.001
72591488|NCT01871402|144714021|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
72591489|NCT01871402|144714022|SUPERIORITY_OR_OTHER||||||<|0.001||||||Statistical significance (\<0.001) was achieved for each of the clinical signs of psoriasis (scaling, erythema, and plaque elevations).|Cochran-Mantel-Haenszel|||Treatment groups were compared with respect to each of the clinical signs of psoriasis (scaling, erythema, and plaque elevation).||||<0.001
72591490|NCT04594941|144714025|OTHER||Least Sqaure (LS) Mean Difference|-0.149|STANDARD_ERROR_OF_MEAN|0.754||0.8452|TWO_SIDED|90.0|-1.431|1.133|||Mixed-effects model for repeated measure|||"Median of Readers: SPE VS HPLC~Analysis was based on Mixed model repeated measures (MMRM) model include the median SRS in each dosing period as the dependent variable, with manufacturing process, period, and dosing sequence as fixed effects, and participant nested within sequence as the random effect."||1.133|-1.431|0.8452
72591491|NCT04594941|144714025|OTHER||LS Mean Difference|-0.015|STANDARD_ERROR_OF_MEAN|1.109||0.989|TWO_SIDED|90.0|-1.899|1.868|||Mixed-effects model for repeated measure|||"SPE VS HPLC: Reader 1~Analysis was based on Mixed model repeated measures (MMRM) model include the median SRS in each dosing period as the dependent variable, with manufacturing process, period, and dosing sequence as fixed effects, and participant nested within sequence as the random effect."||1.868|-1.899|0.9890
72591492|NCT04594941|144714025|OTHER||LS Mean Difference|-0.753|STANDARD_ERROR_OF_MEAN|0.854||0.3852|TWO_SIDED|90.0|-2.204|0.698|||Mixed-effects model for repeated measure|||"Reader 2: SPE VS HPLC~Reader 2: Analysis was based on Mixed model repeated measures (MMRM) model include the median SRS in each dosing period as the dependent variable, with manufacturing process, period, and dosing sequence as fixed effects, and participant nested within sequence as the random effect."||0.698|-2.204|0.3852
72591493|NCT04594941|144714025|OTHER||LS Mean Difference|-0.091|STANDARD_ERROR_OF_MEAN|0.968||0.926|TWO_SIDED|90.0|-1.735|1.554|||Mixed-effects model for repeated measure|||"Reader 3: SPE VS HPLC~Analysis was based on MMRM model include the median SRS in each dosing period as the dependent variable, with manufacturing process, period, and dosing sequence as fixed effects, and participant nested within sequence as the random effect."||1.554|-1.735|0.9260
72591494|NCT04594941|144714026|OTHER||LS Mean Difference|-0.219|STANDARD_ERROR_OF_MEAN|1.109||0.8452|TWO_SIDED|90.0|-2.104|1.667|||Mixed-effects model for repeated measure|||"Median of Readers: SPE VS HPLC~Analysis was based on Mixed model repeated measures (MMRM) model include the median SRS in each dosing period as the dependent variable, with manufacturing process, period, and dosing sequence as fixed effects, and participant nested within sequence as the random effect."||1.667|-2.104|0.8452
72591495|NCT04594941|144714026|OTHER||Least Square Mean (LSM) Difference|-0.023|STANDARD_ERROR_OF_MEAN|1.63||0.989|TWO_SIDED|90.0|-2.793|2.747|||Mixed-effects model for repeated measure|||"Reader 1: SPE VS HPLC~Analysis was based on Mixed model repeated measures (MMRM) model include the median SRS in each dosing period as the dependent variable, with manufacturing process, period, and dosing sequence as fixed effects, and participant nested within sequence as the random effect."||2.747|-2.793|0.9890
72591496|NCT04594941|144714026|OTHER||LS Mean Difference|-1.107|STANDARD_ERROR_OF_MEAN|1.256||0.3852|TWO_SIDED|90.0|-3.241|1.027|||Mixed-effects model for repeated measure|||"Reader 2: SPE VS HPLC~Analysis was based on Mixed model repeated measures (MMRM) model include the median SRS in each dosing period as the dependent variable, with manufacturing process, period, and dosing sequence as fixed effects, and participant nested within sequence as the random effect."||1.027|-3.241|0.3852
72591497|NCT04594941|144714026|OTHER||LS Mean Difference|-0.133|STANDARD_ERROR_OF_MEAN|1.424||0.926|TWO_SIDED|90.0|-2.552|2.285|||Mixed-effects model for repeated measure|||"Reader 3: SPE VS HPLC~Analysis was based on Mixed model repeated measures (MMRM) model include the median SRS in each dosing period as the dependent variable, with manufacturing process, period, and dosing sequence as fixed effects, and participant nested within sequence as the random effect."||2.285|-2.552|0.9260
72591498|NCT04594941|144714027|OTHER||||||<|0.0001|||||||Wilcoxon Signed Rank Test|||Reader 1||||<0.0001
72591499|NCT04594941|144714027|OTHER||||||<|0.0001|||||||Wilcoxon Signed Rank Test|||Reader 2||||<0.0001
72591500|NCT04594941|144714027|OTHER||||||<|0.0001|||||||Wilcoxon Signed Rank Test|||Reader 3||||<0.0001
72591501|NCT04594941|144714027|OTHER|||||||0.0072|||||||Wilcoxon Signed Rank Test|||Reader 1||||0.0072
72591502|NCT04594941|144714027|OTHER|||||||0.0051|||||||Wilcoxon Signed Rank Test|||Reader 2||||0.0051
72591503|NCT04594941|144714027|OTHER|||||||0.0023|||||||Wilcoxon Signed Rank Test|||Reader 3||||0.0023
72591504|NCT04594941|144714027|OTHER|||||||0.0002|||||||Wilcoxon Signed Rank Test|||Reader 1||||0.0002
72591505|NCT04594941|144714027|OTHER||||||<|0.0001|||||||Wilcoxon Signed Rank Test|||Reader 2||||<0.0001
72591506|NCT04594941|144714027|OTHER||||||<|0.0001|||||||Wilcoxon Signed Rank Test|||Reader 3||||<0.0001
72591507|NCT04594941|144714028|OTHER|||||||0.0089|||||||Wilcoxon Signed Rank Test|||Reader 1||||0.0089
72591508|NCT04594941|144714028|OTHER|||||||0.0207|||||||Wilcoxon Signed Rank Test|||Reader 2||||0.0207
72591509|NCT04594941|144714028|OTHER|||||||0.0089|||||||Wilcoxon Signed Rank Test|||Reader 3||||0.0089
72591510|NCT04594941|144714028|OTHER|||||||0.732|||||||Wilcoxon Signed Rank Test|||Reader 1||||0.732
72591511|NCT04594941|144714028|OTHER|||||||0.0083|||||||Wilcoxon Signed Rank Test|||Reader 2||||0.0083
72591512|NCT04594941|144714028|OTHER|||||||0.0412|||||||Wilcoxon (Mann-Whitney)|||Reader 3||||0.0412
72591513|NCT04594941|144714028|OTHER|||||||0.0001|||||||Wilcoxon Signed Rank Test|||Reader 1||||0.0001
72591514|NCT04594941|144714028|OTHER||||||<|0.0001|||||||Wilcoxon Signed Rank Test|||Reader 2||||<0.0001
72591515|NCT04594941|144714028|OTHER||||||<|0.0001|||||||Wilcoxon Signed Rank Test|||Reader 3||||<0.0001
72591516|NCT04594941|144714030|OTHER||Kappa Statistics|1.0|||||TWO_SIDED|95.0|1.0|1.0|||||Kappa statistics was assessed using Cohen's kappa statistics.|Reader 1||1.0000|1.0000|
72591517|NCT04594941|144714030|OTHER||Kappa Statistics|0.6957|||||TWO_SIDED|95.0|0.1696|1.0|||||Kappa statistics was assessed using Cohen's kappa statistics.|Reader 2||1.0000|0.1696|
72591518|NCT04594941|144714030|OTHER||Kappa Statistics|1.0|||||TWO_SIDED|95.0|1.0|1.0|||||Kappa statistics was assessed using Cohen's kappa statistics.|Reader 3||1.0000|1.0000|
72591519|NCT04594941|144714030|OTHER||Kappa Statistics|0.4615|||||TWO_SIDED|95.0|-0.0699|0.993|||||Kappa statistics was assessed using Cohen's kappa statistics.|Reader 1||0.9930|-0.0699|
72591520|NCT04594941|144714030|OTHER||Kappa Statistics|1.0|||||TWO_SIDED|95.0|1.0|1.0|||||Kappa statistics was assessed using Cohen's kappa statistics.|Reader 2||1.0000|1.0000|
72591521|NCT04594941|144714030|OTHER||Kappa Statistics|1.0|||||TWO_SIDED|95.0|1.0|1.0|||||Kappa statistics was assessed using Cohen's kappa statistics.|Reader 3||1.0000|1.0000|
72591522|NCT04594941|144714030|OTHER||Kappa Statistics|0.8811|||||TWO_SIDED|95.0|0.6567|1.0|||||Kappa statistics was assessed using Cohen's kappa statistics.|Reader 1||1.0000|0.6567|
72591523|NCT04594941|144714030|OTHER||Kappa Statistics|0.8828|||||TWO_SIDED|95.0|0.6614|1.0|||||Kappa statistics was assessed using Cohen's kappa statistics.|Reader 2||1.0000|0.6614|
72591524|NCT04594941|144714030|OTHER||Kappa Statistics|0.8811|||||TWO_SIDED|95.0|0.6567|1.0|||||Kappa statistics was assessed using Cohen's kappa statistics.|Reader 3||1.0000|0.6567|
72591525|NCT05896527|144714073|SUPERIORITY||Odds Ratio (OR)|0.46||||0.4839|TWO_SIDED|95.0|0.07|2.37|||Fisher Exact||DC-806 200 mg BID compared to Placebo|||2.37|0.07|0.4839
72591526|NCT05896527|144714073|SUPERIORITY||Odds Ratio (OR)|1.76||||0.4111|TWO_SIDED|95.0|0.51|6.49|||Fisher Exact||DC-806 400 mg BID compared to Placebo|||6.49|0.51|0.4111
72414421|NCT03732209|144338159|SUPERIORITY||F value, group x time interaction|7.155||||0.017|TWO_SIDED|||||This p value reflects the interaction between group (episodic future thinking, control) and time (baseline, Week 8)|ANOVA||Reported values in outcome measures data table reflect mean change in glycosylated hemoglobin for each group (Session 2 - Session 1)|Due to minimal data being available at Weeks 16 and 24 due to COVID-19-related attrition, only baseline (Week 0) and Week 8 data were included in the analysis.||||.017
72591527|NCT05896527|144714073|SUPERIORITY||Odds Ratio (OR)|1.3||||0.7744|TWO_SIDED|95.0|0.36|4.99|||Fisher Exact||DC-806 600 mg QD compared to Placebo|||4.99|0.36|0.7744
72591528|NCT05896527|144714073|SUPERIORITY||Odds Ratio (OR)|3.59||||0.0164|TWO_SIDED|95.0|1.15|12.37|||Fisher Exact||DC-806 800 mg BID compared to Placebo|||12.37|1.15|0.0164
72591529|NCT03085238|144714075|NON_INFERIORITY|The primary safety endpoint will be analyzed using a unilateral one sample test for binomial proportion at the 5% level.||||||0.1309|||||||unilateral one sample test for binomial|||H0: M-Trap freedom MAE incidence \<= 90% - Non-inferiority margin (25%)||||0.1309
72591530|NCT03085238|144714076|NON_INFERIORITY|The primary safety endpoint will be analyzed using a unilateral one sample test for binomial proportion at the 5% level.||||||0.0181|||||||unilateral one sample test for binomial|||H0: M-Trap freedom MAE incidence \<= 90% - Non-inferiority margin (25%)||||.0181
72414422|NCT03732209|144338160|SUPERIORITY||F value, group x time interaction|4.885||||0.042|TWO_SIDED|||||This p value reflects the interaction between group (episodic future thinking, control) and time (baseline, Week 8)|ANOVA||The values reported in the outcome measures data table reflect mean change in AUC (Session 2 - Session 1)|Due to minimal data being available at Weeks 16 and 24 due to COVID-19-related attrition, only baseline (Week 0) and Week 8 data were included in the analysis.||||.042
72414423|NCT03732209|144338161|SUPERIORITY||F value, group x time interaction|2.33||||0.146|TWO_SIDED|||||This p value reflects the interaction between group (episodic future thinking, control) and time (baseline, Week 8)|ANOVA|||Due to minimal data available at Week 16 and 24 due to COVID-19-related attrition, only ratings from Week 8 were included in the analysis.||||.146
72414424|NCT03732209|144338162|SUPERIORITY||Median Difference (Final Values)|1.23||||0.042|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Due to minimal data available at Week 16 and 24 due to COVID-19-related attrition, only ratings from Week 8 were included in the analysis.||||.042
72591531|NCT03875482|144714119|SUPERIORITY||Mean Difference|59.0|||<|0.001|TWO_SIDED|95.0|48.4|69.6|||Chi-squared|||The variable was analyzed using the Chi-square test. Both null hypotheses corresponding to the co-primary endpoints must be rejected simultaneously under a two-sided significance level of 0.05.||69.6|48.4|<0.001
72591532|NCT03875482|144714120|SUPERIORITY||Mean Difference|68.5|||<|0.001|TWO_SIDED|95.0|57.2|79.7|||Chi-squared|||The variable was analyzed using the Chi-square test. Both null hypotheses corresponding to the co-primary endpoints must be rejected simultaneously under a two-sided significance level of 0.05.||79.7|57.2|<0.001
72591533|NCT03875482|144714121|SUPERIORITY||Mean Difference|36.2|||<|0.001|TWO_SIDED|95.0|26.2|46.2|||Chi-squared|||The ranked secondary efficacy endpoints at Week 16 were to be tested between the risankizumab and placebo treatment groups among the ITT Population in a hierarchical order only if the null hypotheses for both primary endpoints had been rejected.||46.2|26.2|<0.001
72591534|NCT03875482|144714122|SUPERIORITY||Mean Difference|37.1|||<|0.001|TWO_SIDED|95.0|27.1|47.2|||Chi-squared|||The ranked secondary efficacy endpoints at Week 16 were to be tested between the risankizumab and placebo treatment groups among the ITT Population in a hierarchical order only if the null hypotheses for both primary endpoints and for the first secondary endpoint had been rejected.||47.2|27.1|<0.001
72591535|NCT03875482|144714123|SUPERIORITY||LS Mean Difference|-36.14|STANDARD_ERROR_OF_MEAN|4.956|<|0.001|TWO_SIDED|95.0|-45.936|-26.346|||Mixed-effect Model Repeat Measurements||Risankizumab - placebo|"Risankizumab vs placebo at Week 4~Mixed-effect Model Repeat Measurements (MMRM): The repeated measures analysis was conducted using a mixed model including the baseline value and observed measurements at all post-baseline visits. The mixed model included the categorical fixed effects of treatment, visit and treatment-by-visit interaction as covariates."||-26.346|-45.936|<0.001
72591536|NCT03875482|144714123|SUPERIORITY||LS Mean Difference|-59.97|STANDARD_ERROR_OF_MEAN|5.326|<|0.001|TWO_SIDED|95.0|-70.501|-49.439|||Mixed-effect Model Repeat Measurements||Risankizumab - placebo|"Risankizumab vs placebo at Week 16~Mixed-effect Model Repeat Measurements (MMRM): The repeated measures analysis was conducted using a mixed model including the baseline value and observed measurements at all post-baseline visits. The mixed model included the categorical fixed effects of treatment, visit and treatment-by-visit interaction as covariates."||-49.439|-70.501|<0.001
72591537|NCT02045862|144714126|SUPERIORITY||Least Squares Mean Difference|-0.45|STANDARD_ERROR_OF_MEAN|0.12|<|0.001|TWO_SIDED|95.0|-0.69|-0.21||The 2-sided P value was for pairwise comparisons between the combination therapy group and the corresponding monotherapy group from the stratified rank ANCOVA.|Stratified Rank ANCOVA|||Difference vs. Mirabegron 50 mg: Difference of the adjusted mean (i.e., least squares mean) was calculated by subtracting the adjusted mean of the mirabegron monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.||-0.21|-0.69|<0.001
72591538|NCT02045862|144714126|SUPERIORITY||Least Squares Mean Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.12||0.002|TWO_SIDED|95.0|-0.37|0.11||The 2-sided P value was for pairwise comparisons between the combination therapy group and the corresponding monotherapy group from the stratified rank ANCOVA.|Stratified Rank ANCOVA|||Difference vs. Solifenacin 5 mg: Difference of the adjusted mean (i.e., least squares mean) was calculated by subtracting the adjusted mean of the solifenacin monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.||0.11|-0.37|0.002
72591539|NCT02045862|144714127|SUPERIORITY||Least Squares Mean Difference|-0.48|STANDARD_ERROR_OF_MEAN|0.15|<|0.001|TWO_SIDED|95.0|-0.77|-0.2||The 2-sided P value was for pairwise comparisons between the combination therapy group and the corresponding monotherapy group from the ANCOVA model.|ANCOVA|||Difference vs. Mirabegron 50 mg: Difference of the adjusted mean (i.e., least squares mean) was calculated by subtracting the adjusted mean of the mirabegron monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.||-0.20|-0.77|<0.001
72591540|NCT02045862|144714127|SUPERIORITY||Least Squares Mean Difference|-0.42|STANDARD_ERROR_OF_MEAN|0.15||0.004|TWO_SIDED|95.0|-0.71|-0.13||The 2-sided P value was for pairwise comparisons between the combination therapy group and the corresponding monotherapy group from the ANCOVA model.|ANCOVA|||Difference vs. Solifenacin 5 mg: Difference of the adjusted mean (i.e., least squares mean) was calculated by subtracting the adjusted mean of the solifenacin monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.||-0.13|-0.71|0.004
72591541|NCT02045862|144714128|SUPERIORITY||Least Squares Mean Difference|15.84|STANDARD_ERROR_OF_MEAN|3.49|<|0.001|TWO_SIDED|95.0|8.99|22.69|||ANCOVA|||Difference vs. Mirabegron 50 mg: Difference of the adjusted mean (i.e., least squares mean) was calculated by subtracting the adjusted mean of the mirabegron monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.||22.69|8.99|<0.001
72591542|NCT02045862|144714128|SUPERIORITY||Least Squares Mean Difference|12.77|STANDARD_ERROR_OF_MEAN|3.47|<|0.001|TWO_SIDED|95.0|5.98|19.57|||ANCOVA|||Difference vs. Solifenacin 5 mg: Difference of the adjusted mean (i.e., least squares mean) was calculated by subtracting the adjusted mean of the solifenacin monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.||19.57|5.98|<0.001
72591543|NCT02045862|144714129|SUPERIORITY||Least Squares Mean Difference|-7.55|STANDARD_ERROR_OF_MEAN|1.27|<|0.001|TWO_SIDED|95.0|-10.05|-5.05|||ANCOVA|||Difference vs. Mirabegron 50 mg: Difference of the adjusted mean (i.e., least squares mean) was calculated by subtracting the adjusted mean of the mirabegron monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.||-5.05|-10.05|<0.001
72591544|NCT02045862|144714129|SUPERIORITY||Least Squares Mean Difference|-4.6|STANDARD_ERROR_OF_MEAN|1.27|<|0.001|TWO_SIDED|95.0|-7.09|-2.12|||ANCOVA|||Difference vs. Solifenacin 5 mg: Difference of the adjusted mean (i.e., least squares mean) was calculated by subtracting the adjusted mean of the solifenacin monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.||-2.12|-7.09|<0.001
72591545|NCT02045862|144714130|SUPERIORITY||Least Squares Mean Difference|0.55|STANDARD_ERROR_OF_MEAN|0.14|<|0.001|TWO_SIDED|95.0|0.28|0.82|||ANCOVA|||Difference vs. Mirabegron 50 mg: Difference of the adjusted mean (i.e., least squares mean) was calculated by subtracting the adjusted mean of the mirabegron monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.||0.82|0.28|<0.001
72414425|NCT01715805|144338192|SUPERIORITY||Least Squares Mean Difference (LSMD)|-0.2||||0.7948|TWO_SIDED|95.0|-1.6|1.2||MMRM with treatment group, study center, visit, and treatment group-by-visit interaction as fixed effects, and the baseline value and baseline by-visit interaction as the covariates was used for analyses.|Mixed Models Analysis||Cariprazine + ADT - Placebo + ADT|||1.2|-1.6|0.7948
72591546|NCT02045862|144714130|SUPERIORITY||Least Squares Mean Difference|0.59|STANDARD_ERROR_OF_MEAN|0.14|<|0.001|TWO_SIDED|95.0|0.32|0.86|||ANCOVA|||Difference vs. Solifenacin 5 mg: Difference of the adjusted mean (i.e., least squares mean) was calculated by subtracting the adjusted mean of the solifenacin monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.||0.86|0.32|<0.001
72591547|NCT02045862|144714132|SUPERIORITY||Rate Ratio|0.67|STANDARD_ERROR_OF_MEAN|0.12|<|0.001|TWO_SIDED|95.0|0.54|0.84|||Mixed Effects Poisson-Negative Binomial|||Rate ratio of number of incontinence episodes during the EoT 7-day diary between the combination therapy group and the mirabegron monotherapy group was calculated from a negative binomial regression model incl. treatment group, sex, age group (\< 65, ≥ 65 years), geographic region and previous study history as factors, log(number of incontinence episodes divided by number of valid diary days) at baseline included as a covariate and number of valid diary day at EoT as the offset variable.||0.84|0.54|<0.001
72591548|NCT02045862|144714132|SUPERIORITY||Rate Ratio|0.77|STANDARD_ERROR_OF_MEAN|0.12||0.029|TWO_SIDED|95.0|0.61|0.97|||Mixed Effects Poisson-Negative Binomial|||Rate ratio of number of incontinence episodes during the EoT 7-day diary between the combination therapy group and the solifenacin monotherapy group was calculated from a negative binomial regression model incl. treatment group, sex, age group (\< 65, ≥ 65 years), geographic region and previous study history as factors, log(number of incontinence episodes divided by number of valid diary days) at baseline included as a covariate and number of valid diary day at EoT as the offset variable.||0.97|0.61|0.029
72591549|NCT02045862|144714133|SUPERIORITY||Least Squares Mean Difference|-3.12|STANDARD_ERROR_OF_MEAN|0.83|<|0.001|TWO_SIDED|95.0|-4.76|-1.49||The two-sided p-value is for pairwise comparisons between the combination therapy group and the mirabegron monotherapy group from stratified rank ANCOVA.|Stratified Rank ANCOVA|||Difference vs. Mirabegron 50 mg (EoT): Difference of the adjusted mean is calculated by subtracting the adjusted mean of the mirabegron monotherapy group from the adjusted mean of the combination therapy group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.||-1.49|-4.76|<0.001
72591550|NCT02045862|144714133|SUPERIORITY||Least Squares Mean Difference|-0.93|STANDARD_ERROR_OF_MEAN|0.84|<|0.001|TWO_SIDED|95.0|-2.57|0.72||The two-sided p-value is for pairwise comparisons between the combination therapy group and the solifenacin monotherapy group from stratified rank ANCOVA.|Stratified Rank ANCOVA|||Difference vs. Solifenacin 5 mg (EoT): Difference of the adjusted mean is calculated by subtracting the adjusted mean of the solifenacin monotherapy group from the adjusted mean of the combination therapy group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.||0.72|-2.57|<0.001
72591551|NCT02045862|144714134|SUPERIORITY||Odds Ratio (OR)|1.6|||<|0.001|TWO_SIDED|95.0|1.26|2.01|||Overdispersed Binomial Regression|||Odds ratio vs. Mirabegron 50 mg (EoT): Odds ratio was from a overdispersed binomial regression model including treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as factors and log transformed baseline mean number of incontinence episodes per 24 hours as a covariate||2.01|1.26|<0.001
72591552|NCT02045862|144714134|SUPERIORITY||Odds Ratio (OR)|1.38||||0.009|TWO_SIDED|95.0|1.08|1.75|||Overdispersed Binomial Regression|||Odds ratio vs. Solifenacin 5 mg (EoT): Odds ratio was from a overdispersed binomial regression model including treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as factors and log transformed baseline mean number of incontinence episodes per 24 hours as a covariate.||1.75|1.08|0.009
72591553|NCT02045862|144714135|SUPERIORITY||Odds Ratio (OR)|1.61|||<|0.001|TWO_SIDED|95.0|1.26|2.05|||Overdispersed Binomial Regression|||Odds ratio vs. Mirabegron 50 mg (EoT): Odds ratio was from a overdispersed binomial regression model including treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as factors and log transformed baseline mean number of incontinence episodes per 24 hours and baseline mean number of micturitions per 24 hours as a covariates.||2.05|1.26|<0.001
72591554|NCT02045862|144714135|SUPERIORITY||Odds Ratio (OR)|1.45||||0.002|TWO_SIDED|95.0|1.14|1.85|||Overdispersed Binomial Regression|||Odds ratio vs. Solifenacin 5 mg (EoT): Odds ratio was from a overdispersed binomial regression model including treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as factors and log transformed baseline mean number of incontinence episodes per 24 hours and baseline mean number of micturitions per 24 hours as a covariates.||1.85|1.14|0.002
72591555|NCT02045862|144714136|SUPERIORITY||Least Squares Mean Difference|-0.43|STANDARD_ERROR_OF_MEAN|0.11|<|0.001|TWO_SIDED|95.0|-0.65|-0.21||The two-sided p-value is for pairwise comparisons between the combination therapy group and the mirabegron monotherapy group from stratified rank ANCOVA.|Stratified Rank ANCOVA|||Difference vs. Mirabegron 50 mg (EoT): Difference of the adjusted mean was calculated by subtracting the adjusted mean of the mirabegron monotherapy group from the adjusted mean of the combination therapy group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.||-0.21|-0.65|<0.001
72591556|NCT02045862|144714136|SUPERIORITY||Least Squares Mean Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.11||0.009|TWO_SIDED|95.0|-0.36|0.09||The two-sided p-value is for pairwise comparisons between the combination therapy group and the solifenacin monotherapy group from stratified rank ANCOVA.|Stratified Rank ANCOVA|||Difference vs. Solifenacin 5 mg (EoT): Difference of the adjusted mean was calculated by subtracting the adjusted mean of the solifenacin monotherapy group from the adjusted mean of the combination therapy group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate||0.09|-0.36|0.009
72591557|NCT02045862|144714137|SUPERIORITY||Rate Ratio|0.62|STANDARD_ERROR_OF_MEAN|0.13|<|0.001|TWO_SIDED|95.0|0.48|0.79|||Negative Binomial Regression|||Rate ratio of number of incontinence episodes during the EoT 7-day diary between the combination therapy group and the mirabegron monotherapy group was calculated from a negative binomial regression model incl. treatment group, sex, age group (\< 65, ≥65 years), geographic region and previous study history as factors, log(number of urgency incontinence episodes divided by number of valid diary days) included as a covariate and post baseline number of valid diary days at EoT as the offset variable||0.79|0.48|<0.001
72591558|NCT02045862|144714137|SUPERIORITY||Rate Ratio|0.75|STANDARD_ERROR_OF_MEAN|0.13||0.023|TWO_SIDED|95.0|0.58|0.96|||Negative Binomial Regression|||Rate ratio of number of incontinence episodes during the EoT 7-day diary between the combination therapy group and the solifenacin monotherapy group is calculated from a negative binomial regression model incl. treatment group, sex, age group (\< 65, ≥ 65 years), geographic region and previous study history as factors, log(number of urgency incontinence episodes divided by number of valid diary days) included as a covariate and post baseline number of valid diary day at EoT as the offset variable||0.96|0.58|0.023
72591559|NCT02045862|144714138|SUPERIORITY||Least Squares Mean Difference|-2.98|STANDARD_ERROR_OF_MEAN|0.78|<|0.001|TWO_SIDED|95.0|-4.51|-1.46||The two-sided p-value is for pairwise comparisons between the combination therapy group and the mirabegron monotherapy group from stratified rank ANCOVA.|Stratified Rank ANCOVA|||Difference vs. Mirabegron 50 mg (EoT): Difference of the adjusted mean was calculated by subtracting the adjusted mean of the mirabegron monotherapy group from the adjusted mean of the combination therapy group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.||-1.46|-4.51|<0.001
72591560|NCT02045862|144714138|SUPERIORITY||Stratified Rank ANCOVA|-0.93|STANDARD_ERROR_OF_MEAN|0.78||0.006|TWO_SIDED|95.0|-2.47|0.61||The two-sided p-value is for pairwise comparisons between the combination therapy group and the solifenacin monotherapy group from stratified rank ANCOVA.|Stratified Rank ANCOVA|||Difference vs. Solifenacin 5 mg (EoT): Difference of the adjusted mean was calculated by subtracting the adjusted mean of the mirabegron monotherapy group from the adjusted mean of the combination therapy group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.||0.61|-2.47|0.006
72591561|NCT02045862|144714140|SUPERIORITY||Odds Ratio (OR)|1.44||||0.002|TWO_SIDED|95.0|1.14|1.8|||Overdispersed Binomial Regression|||Odds ratio vs. Mirabegron 50 mg (EoT): Odds ratio was from a overdispersed binomial regression model including treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as factors and baseline mean number of micturitions per 24 hours as a covariate.||1.8|1.14|0.002
72414426|NCT01715805|144338193|SUPERIORITY||LSMD|-0.7||||0.2784|TWO_SIDED|95.0|-1.9|0.5||MMRM with treatment group, study center, visit, and treatment group-by-visit interaction as fixed effects, and the baseline value and baseline by-visit interaction as the covariates was used for analyses.|Mixed Models Analysis||Cariprazine +ADT - Placebo + ADT|||0.5|-1.9|0.2784
72591562|NCT02045862|144714140|SUPERIORITY||Odds Ratio (OR)|1.37||||0.007|TWO_SIDED|95.0|1.09|1.73|||Overdispersed Binomial Regression|||Odds ratio vs. Solifenacin 5 mg (EoT): Odds ratio was from a overdispersed binomial regression model including treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as factors and baseline mean number of micturitions per 24 hours as a covariate.||1.73|1.09|0.007
72591563|NCT02045862|144714141|SUPERIORITY||Least Squares Mean Difference|-0.78|STANDARD_ERROR_OF_MEAN|0.19|<|0.001|TWO_SIDED|95.0|-1.16|-0.41|||ANCOVA|||Difference vs. Mirabegron 50 mg (EoT): Difference of the adjusted mean was calculated by subtracting the adjusted mean of the mirabegron monotherapy group from the adjusted mean of the combination therapy group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline mean number of micturitions per 24 hours as a covariate.||-0.41|-1.16|<0.001
72591564|NCT02045862|144714141|SUPERIORITY||Least Squares Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.19||0.037|TWO_SIDED|95.0|-0.77|-0.02|||ANCOVA|||Difference vs. Solifenacin 5 mg (EoT): Difference of the adjusted mean was calculated by subtracting the adjusted mean of the solifenacin monotherapy group from the adjusted mean of the combination therapy group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline mean number of micturitions per 24 hours as a covariate.||-0.02|-0.77|0.037
72414427|NCT02890381|144338200|OTHER||% vaccine recipients with solicited AEs|64.0|||||TWO_SIDED|90.0|35.0|86.0||||||||86|35|
72414428|NCT02890381|144338200|OTHER||% placebo recipients with solicited AEs|100.0|||||TWO_SIDED|90.0|61.0|100.0||||||||100|61|
72414429|NCT02890381|144338201|OTHER||% vaccinees with unsolicited AEs|36.0|||||TWO_SIDED|90.0|14.0|65.0||||||||65|14|
72414430|NCT02890381|144338201|OTHER||% placebo with unsolicited AEs|50.0|||||TWO_SIDED|90.0|15.0|85.0||||||||85|15|
72414431|NCT02890381|144338206|SUPERIORITY|||||||0.64||||||Since the sample sizes are unequal, at the suggestion of the DSMB statistician, a 1-sided Fisher's exact test was used to test the hypothesis that the proportions of \>=4-fold rises were higher in the vaccinated group than in the placebo group.|Fisher Exact|||||||0.64
72414432|NCT02890381|144338207|SUPERIORITY|||||||0.73||||||The threshold for statistical significance is 0.05.|Log Rank|||||||0.73
72414433|NCT00395876|144338267|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|36.6||||0.0002||95.0|18.4|54.8||Stratified by baseline weight (\< 30 kg, ≥ 30 kg)|Cochran-Mantel-Haenszel|||||54.8|18.4|0.0002
72414434|NCT00395876|144338268|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.4||||0.1385||95.0|-3.1|25.8||Stratified by baseline weight (\< 30 kg, ≥ 30 kg)|Cochran-Mantel-Haenszel|||||25.8|-3.1|0.1385
72591565|NCT02045862|144714143|SUPERIORITY||Least Squares Mean Difference|-0.73|STANDARD_ERROR_OF_MEAN|0.19|<|0.001|TWO_SIDED|95.0|-1.1|-0.37|||ANCOVA|||Difference vs. Mirabegron 50 mg (EoT): Difference of the adjusted mean was calculated by subtracting the adjusted mean of the mirabegron monotherapy group from the adjusted mean of the combination therapy group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.||-0.37|-1.10|<0.001
72591566|NCT02045862|144714143|SUPERIORITY||Least Squares Mean Difference|-0.39|STANDARD_ERROR_OF_MEAN|0.19||0.036|TWO_SIDED|95.0|-0.76|-0.03|||ANCOVA|||Difference vs. Solifenacin 5 mg (EoT): Difference of the adjusted mean was calculated by subtracting the adjusted mean of the solifenacin monotherapy group from the adjusted mean of the combination therapy group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.||-0.03|-0.76|0.036
72591567|NCT02045862|144714144|SUPERIORITY||Least Squares Mean Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.05||0.059|TWO_SIDED|95.0|-0.19|0.0|||ANCOVA|||Difference vs. Mirabegron 50 mg (EoT): Difference of the adjusted mean was calculated by subtracting the adjusted mean of the mirabegron monotherapy group from the adjusted mean of the combination therapy group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.||0.00|-0.19|0.059
72591568|NCT02045862|144714144|SUPERIORITY||Least Squares Mean Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.05||0.068|TWO_SIDED|95.0|-0.19|0.01|||ANCOVA|||Difference vs. Solifenacin 5 mg (EoT): Difference of the adjusted mean was calculated by subtracting the adjusted mean of the solifenacin monotherapy group from the adjusted mean of the combination therapy group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.||0.01|-0.19|0.068
72591569|NCT02045862|144714145|SUPERIORITY||Rate Ratio|0.9|STANDARD_ERROR_OF_MEAN|0.06||0.067|TWO_SIDED|95.0|0.81|1.01|||Negative Binomial Regression|||Rate ratio of number of nocturia episodes during the EoT 7-day diary between the combination therapy group and the mirabegron monotherapy group was calculated from a negative binomial regression model incl. treatment group, sex, age group (\< 65, ≥ 65 years), geographic region and previous study history as factors, log(number of nocturia episodes divided by number of valid diary days) included as a covariate and post baseline number of valid diary days as the offset variable||1.01|0.81|0.067
72591570|NCT02045862|144714145|SUPERIORITY||Rate Ratio|0.92|STANDARD_ERROR_OF_MEAN|0.06||0.131||95.0|0.82|1.03|||Negative Binomial Regression|||Rate ratio of number of nocturia episodes during the EoT 7-day diary between the combination therapy group and the solifenacin monotherapy group was calculated from a negative binomial regression model incl. treatment group, sex, age group (\< 65, ≥ 65 years), geographic region and previous study history as factors, log(number of nocturia episodes divided by number of valid diary days) included as a covariate and post baseline number of valid diary day as the offset variable.||1.03|0.82|0.131
72591571|NCT02045862|144714146|SUPERIORITY||Least Squares Mean Difference|-0.67|STANDARD_ERROR_OF_MEAN|0.35||0.055|TWO_SIDED|95.0|-1.34|0.01|||ANCOVA|||Difference vs. Mirabegron 50 mg (EoT): Difference of the adjusted mean was calculated by subtracting the adjusted mean of the mirabegron monotherapy group from the adjusted mean of the combination therapy group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.||0.01|-1.34|0.055
72591572|NCT02045862|144714146|SUPERIORITY||Least Squares Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.35||0.048|TWO_SIDED|95.0|-1.39|-0.01|||ANCOVA|||Difference vs. Solifenacin 5 mg (EoT): Difference of the adjusted mean was calculated by subtracting the adjusted mean of the solifenacin monotherapy group from the adjusted mean of the combination therapy group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.||-0.01|-1.39|0.048
72591573|NCT02045862|144714147|SUPERIORITY||Least Squares Mean Difference|-0.42|STANDARD_ERROR_OF_MEAN|0.13||0.002|TWO_SIDED|95.0|-0.69|-0.16|||ANCOVA|||Difference vs. Mirabegron 50 mg (EoT): Difference of the adjusted mean is calculated by subtracting the adjusted mean of the mirabegron monotherapy group from the adjusted mean of the combination therapy group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.||-0.16|-0.69|0.002
72591574|NCT02045862|144714147|SUPERIORITY||Least Squares Mean Difference|-0.28|STANDARD_ERROR_OF_MEAN|0.14||0.039|TWO_SIDED|95.0|-0.55|-0.01|||ANCOVA|||Difference vs. Solifenacin 5 mg (EoT): Difference of the adjusted mean is calculated by subtracting the adjusted mean of the solifenacin monotherapy group from the adjusted mean of the combination therapy group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.||-0.01|-0.55|0.039
72414435|NCT00395876|144338269|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|24.9||||0.0093||95.0|7.1|42.6||Stratified by baseline weight (\< 30 kg, ≥ 30 kg)|Cochran-Mantel-Haenszel|||||42.6|7.1|0.0093
72591575|NCT02045862|144714148|SUPERIORITY||Rate Ratio|0.58|STANDARD_ERROR_OF_MEAN|0.14|<|0.001|TWO_SIDED|95.0|0.45|0.76|||Negative Binomial Regression|||Rate ratio vs. Mirabegron 50 mg (EoT): Rate ratio of number of pads during the EoT 7-day diary between the combination therapy group and the mirabegron monotherapy group is calculated from a negative binomial regression model incl. treatment group, sex, age group (\< 65, ≥ 65 years), geographic region and previous study history as factors, log(number of pads divided by number of valid diary days) included as a covariate and post baseline number of valid diary days as the offset variable.||0.76|0.45|<0.001
72414436|NCT02522715|144338294|OTHER||||||<|0.01|||||||two-sided exact binomial test|||One-sample binomial test with null hypothesis that the percentage of participants with PSA response 1 is equal to 25%.||||<0.01
72591576|NCT02045862|144714148|SUPERIORITY||Rate Ratio|0.76|STANDARD_ERROR_OF_MEAN|0.14||0.044|TWO_SIDED|95.0|0.58|0.99|||Negative Binomial Regression|||Rate ratio vs. Solifenacin 5 mg (EoT): Rate ratio of number of pads during the EoT 7-day diary between the combination therapy group and the solifenacin monotherapy group is calculated from a negative binomial regression model incl. treatment group, sex, age group (\< 65, ≥ 65 years), geographic region and previous study history as factors, log(number of pads divided by number of valid diary days) included as a covariate and post baseline number of valid diary days as the offset variable.||0.99|0.58|0.044
72591577|NCT02045862|144714149|SUPERIORITY||Least Squares Mean Difference|-2.98|STANDARD_ERROR_OF_MEAN|0.92||0.001|TWO_SIDED|95.0|-4.78|-1.18|||ANCOVA|||Difference vs. Mirabegron 50 mg (EoT): Difference of the adjusted mean is calculated by subtracting the adjusted mean of the mirabegron monotherapy group from the adjusted mean of the combination therapy group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.||-1.18|-4.78|0.001
72591578|NCT02045862|144714149|SUPERIORITY||Least Squares Mean Difference|-1.68|STANDARD_ERROR_OF_MEAN|0.93||0.072|TWO_SIDED|95.0|-3.52|0.15|||ANCOVA|||Difference vs. Solifenacin 5 mg (EoT): Difference of the adjusted mean is calculated by subtracting the adjusted mean of the solifenacin monotherapy group from the adjusted mean of the combination therapy group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.||0.15|-3.52|0.072
72591579|NCT02045862|144714151|SUPERIORITY||Least Squares Mean Difference|4.76|STANDARD_ERROR_OF_MEAN|1.12|<|0.001|TWO_SIDED|95.0|2.56|6.96|||ANCOVA|||Difference vs. Mirabegron 50 mg (EoT): Difference of the adjusted mean is calculated by subtracting the adjusted mean of the mirabegron monotherapy group from the adjusted mean of the combination therapy group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.||6.96|2.56|<0.001
72591580|NCT02045862|144714151|SUPERIORITY||Least Squares Mean Difference|2.86|STANDARD_ERROR_OF_MEAN|1.11||0.01|TWO_SIDED|95.0|0.68|5.04|||ANCOVA|||Difference vs. Solifenacin 5 mg (EoT): Difference of the adjusted mean is calculated by subtracting the adjusted mean of the solifenacin monotherapy group from the adjusted mean of the combination therapy group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.||5.04|0.68|0.010
72591581|NCT02045862|144714152|SUPERIORITY||Least Squares Mean Difference|5.6|STANDARD_ERROR_OF_MEAN|1.33|<|0.001|TWO_SIDED|95.0|2.99|8.2|||ANCOVA|||Difference vs. Mirabegron 50 mg (EoT): Difference of the adjusted mean is calculated by subtracting the adjusted mean of the mirabegron monotherapy group from the adjusted mean of the combination therapy group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.||8.20|2.99|<0.001
72414437|NCT03980470|144338303|SUPERIORITY|||||||0.198|||||||ANOVA|||||||0.198
72591582|NCT02045862|144714152|SUPERIORITY||Least Squares Mean Difference|3.01|STANDARD_ERROR_OF_MEAN|1.32||0.022|TWO_SIDED|95.0|0.43|5.6|||ANCOVA|||Difference vs. Solifenacin 5 mg (EoT): Difference of the adjusted mean is calculated by subtracting the adjusted mean of the solifenacin monotherapy group from the adjusted mean of the combination therapy group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.||5.60|0.43|0.022
72414438|NCT03980470|144338304|SUPERIORITY|||||||0.9|||||||ANOVA|||||||0.9
72414439|NCT03980470|144338305|SUPERIORITY|||||||0.8|||||||ANOVA|||||||0.8
72414440|NCT03980470|144338306|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
72414441|NCT03980470|144338307|OTHER|Bland-Altmann analysis (bias)|Mean Difference (Final Values)|-1.42|||||TWO_SIDED|||||||||||||
72414442|NCT01359735|144338308|SUPERIORITY_OR_OTHER|||||||0.263|TWO_SIDED|||||Week 04|Wilcoxon (Mann-Whitney)|||||||0.263
72414443|NCT01359735|144338308|SUPERIORITY_OR_OTHER|||||||0.5|TWO_SIDED|||||Week 13|Wilcoxon (Mann-Whitney)|||||||0.500
72414444|NCT01359735|144338309|SUPERIORITY_OR_OTHER|||||||0.5|TWO_SIDED|||||Over weeks 1 through 4 or Week 4?|Fisher Exact|||||||0.5
72414445|NCT01359735|144338310|SUPERIORITY_OR_OTHER|||||||0.0594|TWO_SIDED||||||Log Rank|||||||0.0594
72591583|NCT02045862|144714153|SUPERIORITY||Least Squares Mean Difference|5.01|STANDARD_ERROR_OF_MEAN|1.21|<|0.001|TWO_SIDED|95.0|2.65|7.38|||ANCOVA|||Difference vs. Mirabegron 50 mg (EoT): Difference of the adjusted mean is calculated by subtracting the adjusted mean of the mirabegron monotherapy group from the adjusted mean of the combination therapy group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.||7.38|2.65|<0.001
72414446|NCT01359735|144338311|SUPERIORITY_OR_OTHER|||||||0.1354|ONE_SIDED|||||3 Weeks|t-test, 1 sided|||||||0.1354
72414447|NCT01359735|144338311|SUPERIORITY_OR_OTHER|||||||0.5|TWO_SIDED|||||12 Weeks|t-test, 1 sided|||||||0.5000
72414448|NCT01359735|144338312|SUPERIORITY_OR_OTHER|||||||0.0841|TWO_SIDED|||||Week 3 Post-surgery|t-test, 1 sided|||||||0.0841
72591584|NCT02045862|144714153|SUPERIORITY||Least Squares Mean Difference|3.78|STANDARD_ERROR_OF_MEAN|1.2||0.002|TWO_SIDED|95.0|1.43|6.13|||ANCOVA|||Difference vs. Solifenacin 5 mg (EoT): Difference of the adjusted mean is calculated by subtracting the adjusted mean of the solifenacin monotherapy group from the adjusted mean of the combination therapy group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.||6.13|1.43|0.002
72591585|NCT02045862|144714154|SUPERIORITY||Least Squares Mean Difference|5.15|STANDARD_ERROR_OF_MEAN|1.36|<|0.001|TWO_SIDED|95.0|2.47|7.83|||ANCOVA|||Difference vs. Mirabegron 50 mg (EoT): Difference of the adjusted mean is calculated by subtracting the adjusted mean of the mirabegron monotherapy group from the adjusted mean of the combination therapy group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.||7.83|2.47|<0.001
72591586|NCT02045862|144714154|SUPERIORITY||Least Squares Mean Difference|3.27|STANDARD_ERROR_OF_MEAN|1.35||0.016|TWO_SIDED|95.0|0.62|5.93|||ANCOVA|||Difference vs. Solifenacin 5 mg (EoT): Difference of the adjusted mean is calculated by subtracting the adjusted mean of the solifenacin monotherapy group from the adjusted mean of the combination therapy group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.||5.93|0.62|0.016
72591587|NCT02045862|144714155|SUPERIORITY||Least Squares Mean Difference|2.68|STANDARD_ERROR_OF_MEAN|0.98||0.006|TWO_SIDED|95.0|0.77|4.59|||ANCOVA|||Difference vs. Mirabegron 50 mg (EoT): Difference of the adjusted mean is calculated by subtracting the adjusted mean of the mirabegron monotherapy group from the adjusted mean of the combination therapy group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.||4.59|0.77|0.006
72591588|NCT02045862|144714155|SUPERIORITY||Least Squares Mean Difference|1.03|STANDARD_ERROR_OF_MEAN|0.97||0.287|TWO_SIDED|95.0|-0.87|2.93|||ANCOVA|||Difference vs. Solifenacin 5 mg (EoT): Difference of the adjusted mean is calculated by subtracting the adjusted mean of the solifenacin monotherapy group from the adjusted mean of the combination therapy group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.||2.93|-0.87|0.287
72591589|NCT02045862|144714157|SUPERIORITY||Least Squares Mean Difference|-0.32|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-0.47|-0.16|||ANCOVA|||Difference vs. Mirabegron 50 mg (EoT): Difference of the adjusted mean is calculated by subtracting the adjusted mean of the mirabegron monotherapy group from the adjusted mean of the combination therapy group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.||-0.16|-0.47|<0.001
72591590|NCT02045862|144714157|SUPERIORITY||Least Squares Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.08||0.011|TWO_SIDED|95.0|-0.36|-0.05|||ANCOVA|||Difference vs. Solifenacin 5 mg (EoT): Difference of the adjusted mean is calculated by subtracting the adjusted mean of the solifenacin monotherapy group from the adjusted mean of the combination therapy group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.||-0.05|-0.36|0.011
72591591|NCT02045862|144714169|SUPERIORITY||Odds Ratio (OR)|1.65|||<|0.001|TWO_SIDED|95.0|1.26|2.15|||Regression, Logistic|||Odds ratio was from a logistic regression model including treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as factors and baseline mean number of incontinence episodes per 24 hours during the last 3 days as a covariate.||2.15|1.26|<0.001
72591592|NCT02045862|144714169|SUPERIORITY||Odds Ratio (OR)|1.27||||0.08|TWO_SIDED|95.0|0.97|1.67|||Regression, Logistic|||Odds ratio was from a logistic regression model including treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as factors and baseline mean number of incontinence episodes per 24 hours during the last 3 days as a covariate.||1.67|0.97|0.080
72591593|NCT02045862|144714170|SUPERIORITY||Odds Ratio (OR)|2.03|||<|0.001|TWO_SIDED|95.0|1.49|2.78|||Regression, Logistic|||Odds ratio was from a logistic regression model including treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as factors and baseline OAB-q subscale as a covariate.||2.78|1.49|<0.001
72414449|NCT01359735|144338312|SUPERIORITY_OR_OTHER|||||||0.178|TWO_SIDED|||||Week 12 Post-surgery|t-test, 1 sided|||||||0.1780
72414450|NCT00791765|144338439|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||van Elteren's test|Stratified by baseline body mass index group||||||<0.0001
72414451|NCT00791765|144338440|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Cochran-Mantel-Haenszel|Stratified by baseline body mass index group||||||<0.0001
72414452|NCT00791765|144338441|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||2-sided pairwise van Elteren's test|Stratified by baseline body mass index group||Comparison of week 24 outcome to week 12 outcome (see Outcome Measure 1)||||<0.0001
72414453|NCT00791765|144338442|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Cochran-Mantel-Haenszel|Two-sided test with modified ridit scores stratified by baseline body mass index group||||||<0.0001
72414454|NCT00156065|144338450|SUPERIORITY_OR_OTHER_LEGACY||Kaplan-Meier Estimate of Loss of Effect|0.8619||||||95.0|0.6912|0.9644|||||Loss of effect = increase in total PANSS \>=30% from start of current study; subjective worsening of schizophrenia/request for dose increase; Clinical Global Impressions of Severity of Illness score \>=6; discontinuation for lack of efficacy.|||0.9644|0.6912|
72591594|NCT02045862|144714170|SUPERIORITY||Odds Ratio (OR)|1.87|||<|0.001|TWO_SIDED|95.0|1.37|2.57|||Regression, Logistic|||Odds ratio was from a logistic regression model including treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as factors and baseline OAB-q subscale as a covariate.||2.57|1.37|<0.001
72591595|NCT02045862|144714171|SUPERIORITY||Odds Ratio (OR)|1.82|||<|0.001|TWO_SIDED|95.0|1.36|2.43|||Regression, Logistic|||Odds ratio was from a logistic regression model including treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as factors and baseline OAB-q subscale as a covariate.||2.43|1.36|<0.001
72591596|NCT02045862|144714171|SUPERIORITY||Odds Ratio (OR)|1.44||||0.014|TWO_SIDED|95.0|1.08|1.92|||Regression, Logistic|||Odds ratio was from a logistic regression model including treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as factors and baseline OAB-q subscale as a covariate.||1.92|1.08|0.014
72591597|NCT02045862|144714172|SUPERIORITY||Odds Ratio (OR)|1.8|||<|0.001|TWO_SIDED|95.0|1.34|2.41|||Regression, Logistic|||Odds ratio was from a logistic regression model including treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as factors and baseline mean number of incontinence episodes per 24 hours as a covariate.||2.41|1.34|<0.001
72591598|NCT02045862|144714172|SUPERIORITY||Odds Ratio (OR)|1.44||||0.019|TWO_SIDED|95.0|1.06|1.95|||Regression, Logistic|||Odds ratio wa from a logistic regression model including treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as factors and baseline mean number of incontinence episodes per 24 hours as a covariate.||1.95|1.06|0.019
72591599|NCT02045862|144714173|SUPERIORITY||Odds Ratio (OR)|1.67|||<|0.001|TWO_SIDED|95.0|1.26|2.19|||Regression, Logistic|||Odds ratio was from a logistic regression model including treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as factors and baseline mean number of incontinence episodes per 24 hours as a covariate.||2.19|1.26|<0.001
72591600|NCT02045862|144714173|SUPERIORITY||Odds Ratio (OR)|1.23||||0.133|TWO_SIDED|95.0|0.94|1.62|||Regression, Logistic|||Odds ratio was from a logistic regression model including treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as factors and baseline mean number of incontinence episodes per 24 hours as a covariate.||1.62|0.94|0.133
72591601|NCT02045862|144714174|SUPERIORITY||Odds Ratio (OR)|1.55||||0.002|TWO_SIDED|95.0|1.18|2.03|||Regression, Logistic|||Odds ratio was from a logistic regression model including treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as factors and baseline mean number of micturitions per 24 hours as a covariate.||2.03|1.18|0.002
72591602|NCT02045862|144714174|SUPERIORITY||Odds Ratio (OR)|1.48||||0.006|TWO_SIDED|95.0|1.12|1.95|||Regression, Logistic|||Odds ratio was from a logistic regression model including treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as factors and baseline mean number of micturitions per 24 hours as a covariate.||1.95|1.12|0.006
72591603|NCT02045862|144714175|SUPERIORITY||Odds Ratio (OR)|1.68|||<|0.001|TWO_SIDED|95.0|1.24|2.29|||Regression, Logistic|||Odds ratio is from a logistic regression model including treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as factors and baseline PPBC as a covariate.||2.29|1.24|<0.001
72591604|NCT02045862|144714175|SUPERIORITY||Odds Ratio (OR)|1.29||||0.109|TWO_SIDED|95.0|0.94|1.77|||Regression, Logistic|||Odds ratio was from a logistic regression model including treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as factors and baseline PPBC as a covariate.||1.77|0.94|0.109
72591605|NCT02045862|144714176|SUPERIORITY||Odds Ratio (OR)|1.69|||<|0.001|TWO_SIDED|95.0|1.26|2.25|||Regression, Logistic|||Odds ratio was from a logistic regression model including treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as factors and baseline PPBC as a covariate.||2.25|1.26|<0.001
72591606|NCT02045862|144714176|SUPERIORITY||Odds Ratio (OR)|1.62|||<|0.001|TWO_SIDED|95.0|1.22|2.16|||Regression, Logistic|||Odds ratio was from a logistic regression model including treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as factors and baseline PPBC as a covariate.||2.16|1.22|<0.001
72591607|NCT02045862|144714177|SUPERIORITY||Odds Ratio (OR)|1.99|||<|0.001|TWO_SIDED|95.0|1.5|2.62|||Regression, Logistic|||Odds ratio was from a logistic regression model including treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as factors and baseline mean number of incontinence episodes per 24 hours and baseline OAB-q symptom bother scale as covariates.||2.62|1.50|<0.001
72591608|NCT02045862|144714177|SUPERIORITY||Odds Ratio (OR)|1.79|||<|0.001|TWO_SIDED|95.0|1.35|2.36|||Regression, Logistic|||Odds ratio is from a logistic regression model including treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as factors and baseline mean number of incontinence episodes per 24 hours and baseline OAB-q symptom bother scale as covariates.||2.36|1.35|<0.001
72414455|NCT00156065|144338450|SUPERIORITY_OR_OTHER_LEGACY||Kaplan-Meier Estimate of Loss of Effect|0.8834||||||95.0|0.7744|0.955|||||Loss of effect = increase in total PANSS \>=30% from start of current study; subjective worsening of schizophrenia/request for dose increase; Clinical Global Impressions of Severity of Illness score \>=6; discontinuation for lack of efficacy.|||0.9550|0.7744|
72591609|NCT02045862|144714178|SUPERIORITY||Odds Ratio (OR)|1.93|||<|0.001|TWO_SIDED|95.0|1.46|2.54|||Regression, Logistic|||Odds ratio was from a logistic regression model including treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as factors and baseline mean number of incontinence episodes per 24 hours and baseline OAB-q HRQL total score as covariates.||2.54|1.46|<0.001
72591610|NCT02045862|144714178|SUPERIORITY||Odds Ratio (OR)|1.59||||0.001|TWO_SIDED|95.0|1.2|2.09|||Regression, Logistic|||Odds ratio was from a logistic regression model including treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as factors and baseline mean number of incontinence episodes per 24 hours and baseline OAB-q HRQL total score as covariates.||2.09|1.20|0.001
72591611|NCT02045862|144714179|SUPERIORITY||Odds Ratio (OR)|1.7|||<|0.001|TWO_SIDED|95.0|1.28|2.26|||Regression, Logistic|||Odds ratio was from a logistic regression model including treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as factors and baseline mean number of incontinence episodes per 24 hours and baseline PPBC as covariates.||2.26|1.28|<0.001
72591612|NCT02045862|144714179|SUPERIORITY||Odds Ratio (OR)|1.4||||0.019|TWO_SIDED|95.0|1.06|1.86|||Regression, Logistic|||Odds ratio was from a logistic regression model including treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as factors and baseline mean number of incontinence episodes per 24 hours and baseline PPBC as covariates.||1.86|1.06|0.019
72591613|NCT02045862|144714180|SUPERIORITY||Odds Ratio (OR)|1.86|||<|0.001|TWO_SIDED|95.0|1.4|2.46|||Regression, Logistic|||Odds ratio was from a logistic regression model including treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as factors and baseline mean number of incontinence episodes per 24 hours, baseline OAB-q symptom bother scale and baseline PPBC as covariates.||2.46|1.40|<0.001
72591614|NCT02045862|144714180|SUPERIORITY||Odds Ratio (OR)|1.58||||0.001|TWO_SIDED|95.0|1.19|2.09|||Regression, Logistic|||Odds ratio was from a logistic regression model including treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as factors and baseline mean number of incontinence episodes per 24 hours, baseline OAB-q symptom bother scale and baseline PPBC as covariates.||2.09|1.19|0.001
72591615|NCT02045862|144714181|SUPERIORITY||Odds Ratio (OR)|1.76|||<|0.001|TWO_SIDED|95.0|1.33|2.34|||Regression, Logistic|||Odds ratio was from a logistic regression model including treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as factors and baseline mean number of incontinence episodes per 24 hours, baseline OAB-q HRQL total score and baseline PPBC as covariates.||2.34|1.33|<0.001
72591616|NCT02045862|144714181|SUPERIORITY||Odds Ratio (OR)|1.43||||0.012|TWO_SIDED|95.0|1.08|1.89|||Regression, Logistic|||Odds ratio was from a logistic regression model including treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as factors and baseline mean number of incontinence episodes per 24 hours, baseline OAB-q HRQL total score and baseline PPBC as covariates.||1.89|1.08|0.012
72591617|NCT02357706|144714199|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|"We are testing the Hypothesis that there is a significant difference between CPAP A and CPAP B~The Null Hypothesis is H0 = One CPAP is inferior to the other CPAP The Alternate Hypothesis is H1 = There is no significant difference between the CPAPs"|Mean Difference (Final Values)|1.24||||0.537|TWO_SIDED||||||t-test, 1 sided|||"Comparison of AHI/ oxygen desaturation index (ODI) of Device A compared with Device B.~Efficacy is defined as a residual AHI and ODI on each night of the trial. PSG scored AHI and ODI will be collected on both trial nights (excluding the ramp period); and compared using the Paired T test"||||0.537
72591618|NCT02357706|144714199|NON_INFERIORITY|"We are testing the Hypothesis that there is a significant difference between CPAP A and CPAP B~The Null Hypothesis is H0 = One CPAP is inferior to the other CPAP The Alternate Hypothesis is H1 = There is no significant difference between the CPAPs~The expected difference mu is 0 events/hr The Non-Inferiority Margin delta is 0.75 events/hr (A difference of 1 event per hour is seen as clinically significant. 0.75 has been chosen to ensure any AHI change is seen)."|Mean Difference (Net)|1.24||||0.05|TWO_SIDED||||||t-test, 1 sided|||||||0.05
72414456|NCT00156065|144338450|SUPERIORITY_OR_OTHER_LEGACY||Kaplan-Meier Estimate of Loss of Effect|0.9376||||||95.0|0.7631|0.9952|||||Loss of effect = increase in total PANSS \>=30% from start of current study; subjective worsening of schizophrenia/request for dose increase; Clinical Global Impressions of Severity of Illness score \>=6; discontinuation for lack of efficacy.|||0.9952|0.7631|
72591619|NCT02357706|144714200|NON_INFERIORITY|"We are testing the Hypothesis that there is a significant difference between CPAP A and CPAP B~The Null Hypothesis is H0 = One CPAP is inferior to the other CPAP The Alternate Hypothesis is H1 = There is no significant difference between the CPAPs~The expected difference mu is 0 events/hr The Non-Inferiority Margin delta is 0.75 events/hr (A difference of 1 event per hour is seen as clinically significant. 0.75 has been chosen to ensure any AHI change is seen)."|Mean Difference (Net)|2.69||||0.205|TWO_SIDED||||||t-test, 1 sided|||||||0.205
72591620|NCT02357706|144714200|NON_INFERIORITY|"We are testing the Hypothesis that there is a significant difference between CPAP A and CPAP B~The Null Hypothesis is H0 = One CPAP is inferior to the other CPAP The Alternate Hypothesis is H1 = There is no significant difference between the CPAPs~The expected difference mu is 0 events/hr The Non-Inferiority Margin delta is 0.75 events/hr (A difference of 1 event per hour is seen as clinically significant. 0.75 has been chosen to ensure any AHI change is seen)."|Mean Difference (Net)|2.69||||0.134|TWO_SIDED||||||t-test, 1 sided|||||||0.134
72591621|NCT01044290|144714260|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.2|||<|0.61|TWO_SIDED|95.0|-1.1|0.7|||Mixed Models Analysis|Adjusted for Palliative Performance Scale (low versus high) stratification variable.||Comparison at 5 weeks||.7|-1.1|<0.61
72591622|NCT01044290|144714260|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.1|||<|0.02|TWO_SIDED|95.0|0.2|2.0|||Mixed Models Analysis|Adjusted for Palliative Performance Scale (low versus high) stratification variable.||Comparison at 5 weeks.||2.0|.2|<.02
72414457|NCT00920426|144338452|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.09|||<|0.001|TWO_SIDED|95.0|-2.547|-1.632||Analysis of covariance (ANCOVA) with treatment as fixed effect, and Baseline HIV-1 RNA as covariate.|ANCOVA|||||-1.632|-2.547|<0.001
72414458|NCT00920426|144338478|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.804|||<|0.001|TWO_SIDED|95.0|-2.173|-1.436||ANCOVA with treatment as fixed effect, and baseline HIV-1 RNA as covariate.|ANCOVA|||||-1.436|-2.173|<0.001
72414459|NCT00920426|144338479|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|||||||<0.0001
72591623|NCT01044290|144714261|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1|||=|0.9|TWO_SIDED|95.0|-1.2|1.1|||Mixed Models Analysis|Adjusted for Palliative Performance Scale (low versus high) stratification variable.||Comparison at 5 weeks||1.1|-1.2|=.9
72414460|NCT01292603|144338490|NON_INFERIORITY_OR_EQUIVALENCE|A standard non-inferiority margin of 0.8 for the ratio of Ctrough was used. The non-inferiority limit corresponds to a maximal 20 percent (%) loss in Ctrough which is considered acceptable given the high variability and range of Ctrough data, with an 80% power and a one-sided alpha of 0.05.|Adjusted geometric mean ratio|1.533|||||TWO_SIDED|90.0|1.269|1.852|||||Ratio based on geometric scale and adjusted for the covariate tumor load at baseline.|||1.852|1.269|
72414461|NCT01292603|144338491|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|1.102|||||TWO_SIDED|90.0|0.979|1.242|||||Ratio based on geometric scale and adjusted for the covariate tumor load at baseline.|||1.242|0.979|
72414462|NCT01292603|144338492|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|0.719|||||TWO_SIDED|90.0|0.653|0.792|||||Ratio based on geometric scale and adjusted for the covariate tumor load at baseline.|||0.792|0.653|
72414463|NCT01292603|144338493|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|14.884|||||TWO_SIDED|90.0|11.215|19.755|||||Ratio based on geometric scale and adjusted for the covariate tumor load at baseline.|||19.755|11.215|
72414464|NCT01292603|144338494|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|1.01|||||TWO_SIDED|90.0|0.895|1.139|||||Ratio based on geometric scale and adjusted for the covariate tumor load at baseline.|||1.139|0.895|
72591624|NCT01044290|144714261|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.02|||<|0.97|TWO_SIDED|95.0|-1.2|1.1|||Mixed Models Analysis|Adjusted for Palliative Performance Scale (low versus high) stratification variable||Comparison at 5 weeks.||1.1|-1.2|<.97
72591625|NCT01044290|144714262|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.1|||<|0.91|TWO_SIDED|95.0|-1.4|1.5|||Mixed Models Analysis|Adjusted for Palliative Performance Scale (low versus high) stratification variable||Comparison at 5 weeks||1.5|-1.4|<.91
72414465|NCT03586648|144338517|SUPERIORITY|Statistically superiority will be concluded if the lower limit of the confidence intervals of the Test lens is greater than 32 points.|Least-square Mean|39.3|STANDARD_ERROR_OF_MEAN|3.31|||TWO_SIDED|95.0|32.7|45.9|||Linear Mixed Model|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.||Data only from the first period will be used if period effect is significant.||45.9|32.7|
72414466|NCT03586648|144338518|NON_INFERIORITY|Statistically superiority will be concluded if the lower limit of the confidence intervals of the Test lens is greater than -5 points.|Least-square Mean Difference|-11.5|STANDARD_ERROR_OF_MEAN|4.14|||TWO_SIDED|95.0|-19.7|-3.3|||Linear Mixed Model|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.|Mean difference was calculated as Test minus Control.|The non-inferiority of the Test lens relative to the Control will be concluded if the lower confidence limit of LSM difference is above the non-inferiority margin -5.||-3.3|-19.7|
72591626|NCT01044290|144714262|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.6|||=|0.42|TWO_SIDED|95.0|-2.1|0.9|||Mixed Models Analysis|Adjusted for Palliative Performance Scale (low versus high) stratification variable||Comparison at 5 weeks||0.9|-2.1|=.42
72591627|NCT01044290|144714263|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.6|||=|0.58|TWO_SIDED|95.0|-1.5|2.8|||Mixed Models Analysis|Adjusted for Palliative Performance Scale (low versus high) stratification variable.||Comparison at 5 weeks||2.8|-1.5|=.58
72591628|NCT01044290|144714263|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.04|||<|0.97|TWO_SIDED|95.0|-2.1|2.2|||Mixed Models Analysis|Adjusted for Palliative Performance Scale (low versus high) stratification variable.||Comparison at 5 weeks.||2.2|-2.1|<.97
72591629|NCT01044290|144714264|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.9||||0.25|TWO_SIDED|95.0|-0.6|2.4|||Mixed Models Analysis|Adjusted for Palliative Performance Scale (low versus high) stratification variable.||Comparison at 5 weeks||2.4|-.6|.25
72591630|NCT01044290|144714264|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.6|||<|0.05|TWO_SIDED|95.0|0.05|3.1|||Mixed Models Analysis|Adjusted for Palliative Performance Scale (low versus high) stratification variable.||Comparison at 5 weeks||3.1|.05|<.05
72414467|NCT00377234|144338522|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Null hypothesis: Preference rate (including patients not expressing treatment preference and considering order treatments were received) for monthly ibandronate = 50%. Null hypothesis is rejected if P-value was below significance threshold of P \<0.05|Garts Test|||||||<0.0001
72591631|NCT01044290|144714265|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.4|||<|0.57|TWO_SIDED|95.0|-1.0|1.8|||Mixed Models Analysis|Adjusted for Palliative Performance Scale (low versus high) stratification variable. Sex item omitted from scale.||Comparison at 5 weeks.||1.8|-1.0|<.57
72591632|NCT01044290|144714265|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.4|||=|0.055|TWO_SIDED|95.0|-0.03|2.7|||Mixed Models Analysis|Adjusted for Palliative Performance Scale (low versus high) stratification variable. Sex item omitted from scale.||Comparison at 5 weeks.||2.7|-0.03|=0.055
72591633|NCT01967706|144714272|OTHER||Geometric LS Mean Ratio|88.47|||||TWO_SIDED|95.0|68.64|114.03|||ANOVA|The model included terms for sequence, subject nested within sequence, period, and product as fixed effect factors.|LS mean ratio (mTHS - Group 1:mCC - Group 1)|The objective of this study was to determine the point estimate and precision of the nicotine bioavailability (ratio of mTHS:mCC) for Cmax, therefore, there was no statistical hypothesis to be tested for this objective.||114.03|68.64|
72591634|NCT01967706|144714273|OTHER||Geometric LS Mean Ratio|98.13|||||TWO_SIDED|95.0|80.61|119.46|||ANOVA|The model included terms for sequence, subject nested within sequence, period, and product as fixed effect factors.|LS mean ratio (mTHS - Group 1:mCC - Group 1)|The objective of this study was to determine the point estimate and precision of the nicotine bioavailability (ratio of mTHS:mCC) for AUC(0-last), therefore, there was no statistical hypothesis to be tested for this objective.||119.46|80.61|
72591635|NCT02347891|144714280|SUPERIORITY||Risk Ratio (RR)|0.5||||0.6|TWO_SIDED|95.0|0.08|2.65|||ANOVA|||Definition of Improvement (DOI) at week 40||2.65|0.08|0.60
72591636|NCT02347891|144714280|SUPERIORITY||Risk Ratio (RR)|0.6||||0.61|TWO_SIDED|95.0|0.16|1.82|||ANOVA|||Percent patients reaching Total improvement score of ≥40 at Week 40||1.82|0.16|0.61
72591637|NCT02347891|144714280|SUPERIORITY||Risk Ratio (RR)|0.0||||0.23|TWO_SIDED|95.0|0.0|1.47|||ANOVA|||Percent of patient with major improvement TIS ≥60 at Week 40||1.47|0|0.23
72591638|NCT02347891|144714281|SUPERIORITY|||||||0.92|||||||ANOVA|||Mean Total Improvement Score (TIS) during Randomized Phase at Week 40||||0.92
72591639|NCT02347891|144714282|SUPERIORITY||Risk Ratio (RR)|0.0||||0.23|TWO_SIDED|95.0|0.0|1.47|||ANOVA|||Definition of Improvement (DOI) at Week 64||1.47|0|0.23
72591640|NCT02347891|144714282|SUPERIORITY||Risk Ratio (RR)|0.75||||0.99|TWO_SIDED|95.0|0.19|2.51|||ANOVA|||Percent patients reaching Total improvement score of ≥40 at Week 64||2.51|0.19|0.99
72591641|NCT02347891|144714282|SUPERIORITY||Risk Ratio (RR)|0.0||||0.23|TWO_SIDED|95.0|0.0|1.47|||ANOVA|||Percent of patient with major improvement TIS ≥60 at Week 64||1.47|0|0.23
72591642|NCT02347891|144714283|SUPERIORITY|||||||0.62|||||||ANOVA|||Mean Total Improvement Score (TIS) after Open Label Phase at 64 Week||||0.62
72591643|NCT02122770|144714346|SUPERIORITY||Geometric LS Mean Ratio|98.75|||||TWO_SIDED|90.0|82.6|118.05||||||Natural-log transformed pharmacokinetic parameters were fit using a mixed effects model with study day as a fixed effect and participant as a random effect. Geometric least square (LS) means and geometric LS mean ratio were back-transformed least squares mean and treatment mean difference.||118.05|82.60|
72591644|NCT02122770|144714347|SUPERIORITY||Geometric LS Mean Ratio|110.21|||||TWO_SIDED|90.0|102.34|118.69||||||Natural-log transformed pharmacokinetic parameters were fit using a mixed effects model with study day as a fixed effect and participant as a random effect. Geometric LS means and geometric LS mean ratio were back-transformed least squares mean and treatment mean difference.||118.69|102.34|
72591645|NCT02122770|144714348|SUPERIORITY||Geometric LS Mean Ratio|110.66|||||TWO_SIDED|90.0|102.53|119.43||||||Natural-log transformed pharmacokinetic parameters were fit using a mixed effects model with study day as a fixed effect and participant as a random effect. Geometric LS means and geometric LS mean ratio were back-transformed least squares mean and treatment mean difference.||119.43|102.53|
72591646|NCT02122770|144714349|SUPERIORITY||Geometric LS Mean Ratio|113.05|||||TWO_SIDED|90.0|85.35|149.74||||||Natural-log transformed pharmacokinetic parameters were fit using a mixed effects model with study day as a fixed effect and participant as a random effect. Geometric LS means and geometric LS mean ratio were back-transformed least squares mean and treatment mean difference.||149.74|85.35|
72591647|NCT02122770|144714349|SUPERIORITY||Geometric LS Mean Ratio|159.55|||||TWO_SIDED|90.0|89.97|282.96||||||Natural-log transformed pharmacokinetic parameters were fit using a mixed effects model with study day as a fixed effect and participant as a random effect. Geometric LS means and geometric LS mean ratio were back-transformed least squares mean and treatment mean difference||282.96|89.97|
72591648|NCT02122770|144714349|SUPERIORITY||Geometric LS Mean Ratio|77.26|||||TWO_SIDED|90.0|55.19|108.17||||||Natural-log transformed pharmacokinetic parameters were fit using a mixed effects model with study day as a fixed effect and participant as a random effect. Geometric LS means and geometric LS mean ratio were back-transformed least squares mean and treatment mean difference.||108.17|55.19|
72591649|NCT02122770|144714350|SUPERIORITY||Geometric LS Mean Ratio|121.57|||||TWO_SIDED|90.0|110.92|133.24||||||Natural-log transformed pharmacokinetic parameters were fit using a mixed effects model with study day as a fixed effect and participant as a random effect. Geometric LS means and geometric LS mean ratio were back-transformed least squares mean and treatment mean difference.||133.24|110.92|
72591650|NCT02122770|144714350|SUPERIORITY||Geometric LS Mean Ratio|130.16|||||TWO_SIDED|90.0|106.99|158.35||||||Natural-log transformed pharmacokinetic parameters were fit using a mixed effects model with study day as a fixed effect and participant as a random effect. Geometric LS means and geometric LS mean ratio were back-transformed least squares mean and treatment mean difference||158.35|106.99|
72591651|NCT02122770|144714350|SUPERIORITY||Geometric LS Mean Ratio|101.36|||||TWO_SIDED|90.0|90.72|113.23||||||Natural-log transformed pharmacokinetic parameters were fit using a mixed effects model with study day as a fixed effect and participant as a random effect. Geometric LS means and geometric LS mean ratio were back-transformed least squares mean and treatment mean difference.||113.23|90.72|
72591652|NCT02122770|144714351|SUPERIORITY||Geometric LS Mean Ratio|122.95|||||TWO_SIDED|90.0|112.13|134.82||||||Natural-log transformed pharmacokinetic parameters were fit using a mixed effects model with study day as a fixed effect and participant as a random effect. Geometric LS means and geometric LS mean ratio were back-transformed least squares mean and treatment mean difference.||134.82|112.13|
72591653|NCT02122770|144714351|SUPERIORITY||Geometric LS Mean Ratio|130.16|||||TWO_SIDED|90.0|106.99|158.35||||||Natural-log transformed pharmacokinetic parameters were fit using a mixed effects model with study day as a fixed effect and participant as a random effect. Geometric LS means and geometric LS mean ratio were back-transformed least squares mean and treatment mean difference||158.35|106.99|
72591654|NCT02122770|144714351|SUPERIORITY||Geometric LS Mean Ratio|100.89|||||TWO_SIDED|90.0|91.14|111.68||||||Natural-log transformed pharmacokinetic parameters were fit using a mixed effects model with study day as a fixed effect and participant as a random effect. Geometric LS means and geometric LS mean ratio were back-transformed least squares mean and treatment mean difference.||111.68|91.14|
72591655|NCT00373958|144714366|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the difference between the 2 groups \> -10%.|Difference|-3.6||||||95.0|-7.3|-0.1||||||For serotype 4 the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||-0.1|-7.3|
72591656|NCT00373958|144714366|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the difference between the 2 groups \> -10%.|Difference|-5.5||||||95.0|-10.9|-0.1||||||For serotype 6B the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||-0.1|-10.9|
72591657|NCT00373958|144714366|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the difference between the 2 groups \> -10%.|Difference|-7.9||||||95.0|-12.4|-4.0||||||For serotype 9V the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||-4.0|-12.4|
72591658|NCT00373958|144714366|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the difference between the 2 groups \> -10%.|Difference|0.4||||||95.0|-2.7|3.5||||||For serotype 14 the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||3.5|-2.7|
72591659|NCT00373958|144714366|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the difference between the 2 groups \> -10%.|Difference|-1.6||||||95.0|-4.7|1.2||||||For serotype 18C the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||1.2|-4.7|
72591660|NCT00373958|144714366|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the difference between the 2 groups \> -10%.|Difference|0.4||||||95.0|-2.4|3.4||||||For serotype 19F the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||3.4|-2.4|
72591661|NCT00373958|144714366|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the difference between the 2 groups \> -10%.|Difference|-3.6||||||95.0|-8.5|1.2||||||For serotype 23F the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||1.2|-8.5|
72591662|NCT00373958|144714367|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the GMC ratio (13vPnC/7vPnC) \> 0.5 (2-fold criterion).|Ratio|0.68||||||95.0|0.57|0.8||||||For serotype 4 the GMC ratio (13vPnC/7vPnC) was calculated||0.80|0.57|
72591663|NCT00373958|144714367|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the GMC ratio (13vPnC/7vPnC) \> 0.5 (2-fold criterion).|Ratio|0.74||||||95.0|0.61|0.89||||||For serotype 6B the GMC ratio (13vPnC/7vPnC) was calculated||0.89|0.61|
72414468|NCT00377234|144338522|SUPERIORITY_OR_OTHER||||||<|0.0001||||||The reported p-values for the primary analysis test whether the overall preference rate for ibandronate equals 50%. Preference within each sequence is not tested.|Prescott Test|||||||<0.0001
72591664|NCT00373958|144714367|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the GMC ratio (13vPnC/7vPnC) \> 0.5 (2-fold criterion).|Ratio|0.72||||||95.0|0.62|0.85||||||For serotype 9V the GMC ratio (13vPnC/7vPnC) was calculated||0.85|0.62|
72591665|NCT00373958|144714367|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the GMC ratio (13vPnC/7vPnC) \> 0.5 (2-fold criterion).|Ratio|0.72||||||95.0|0.6|0.86||||||For serotype 14 the GMC ratio (13vPnC/7vPnC) was calculated||0.86|0.60|
72591666|NCT00373958|144714367|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the GMC ratio (13vPnC/7vPnC) \> 0.5 (2-fold criterion).|Ratio|0.68||||||95.0|0.57|0.81||||||For serotype 18C the GMC ratio (13vPnC/7vPnC) was calculated||0.81|0.57|
72591667|NCT00373958|144714367|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the GMC ratio (13vPnC/7vPnC) \> 0.5 (2-fold criterion).|Ratio|1.18||||||95.0|0.98|1.41||||||For serotype 19F the GMC ratio (13vPnC/7vPnC) was calculated||1.41|0.98|
72591668|NCT00373958|144714367|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the GMC ratio (13vPnC/7vPnC) \> 0.5 (2-fold criterion).|Ratio|0.65||||||95.0|0.54|0.78||||||For serotype 23F the GMC ratio (13vPnC/7vPnC) was calculated||0.78|0.54|
72591669|NCT00373958|144714368|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) was \> -10%.|Difference|0.1||||||95.0|-2.9|3.1||||||For Haemophilus influenzae type b the difference in percentage between the two groups (13vPnC - 7vPnC) at 0.15μg/mL threshold was calculated.||3.1|-2.9|
72591670|NCT00373958|144714368|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) was \> -10%.|Difference|-0.6||||||95.0|-8.3|7.0||||||For Haemophilus influenzae type b the difference in percentage between the two groups (13vPnC - 7vPnC) at 1.0 μg/mL threshold was calculated.||7.0|-8.3|
72591671|NCT00373958|144714368|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) was \> -10%.|Difference|-0.4||||||95.0|-4.3|3.5||||||For diphtheria toxoid the difference in percentage between the two groups (13vPnC - 7vPnC) at 0.1 IU/mL threshold was calculated.||3.5|-4.3|
72591672|NCT00373958|144714368|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) was \> -10%.|Difference|1.7||||||95.0|-2.1|5.6||||||For Pertussis FHA the difference in percentage between the two groups (13vPnC - 7vPnC) at 40.5 EU/mL threshold was calculated.||5.6|-2.1|
72591673|NCT00373958|144714368|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) was \> -10%.|Difference|-0.9||||||95.0|-5.2|3.4||||||For Pertussis PT the difference in percentage between the two groups (13vPnC - 7vPnC) at 16.5 EU/mL threshold was calculated.||3.4|-5.2|
72591674|NCT00373958|144714368|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) was \> -10%.|Difference|-2.1||||||95.0|-6.4|2.0||||||For Pertussis PRN the difference in percentage between the two groups (13vPnC - 7vPnC) at 26 EU/mL threshold was calculated.||2.0|-6.4|
72414469|NCT00907153|144338527|SUPERIORITY||Mean Difference (Net)|-0.017||||0.05|TWO_SIDED|95.0|-0.034|0.0|||Regression, Linear|Model-based differences adjusted for oral contraceptive use and season.||||-0.000|-0.034|0.05
72414470|NCT00907153|144338528|SUPERIORITY||Mean Difference (Net)|-1.14||||0.62|TWO_SIDED|95.0|-5.89|3.62|||Regression, Linear|Model-based differences adjusted for oral contraceptive use and season.||||3.62|-5.89|0.62
72591675|NCT00373958|144714369|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|0.0||||||95.0|-1.6|1.7||||||For Haemophilus influenzae type b the difference in percentage between the two groups (13vPnC - 7vPnC) at 0.15μg/mL threshold was calculated.||1.7|-1.6|
72591676|NCT00373958|144714369|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|-1.6||||||95.0|-7.1|3.8||||||For Haemophilus influenzae type b the difference in percentage between the two groups (13vPnC - 7vPnC) at 1.0μg/mL threshold was calculated.||3.8|-7.1|
72591677|NCT00373958|144714369|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -5%.|Difference|-0.8||||||95.0|-4.5|2.9||||||For Measles the difference in percentage between the two groups (13vPnC - 7vPnC) at ≥1.10 I.V. threshold was calculated.||2.9|-4.5|
72591678|NCT00373958|144714369|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -5%.|Difference|3.6||||||95.0|-4.7|11.9||||||For Mumps the difference in percentage between the two groups (13vPnC - 7vPnC) at ≥1.10 I.V. threshold was calculated.||11.9|-4.7|
72591679|NCT00373958|144714369|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -5%.|Difference|1.2||||||95.0|-4.4|6.9||||||For Rubella the difference in percentage between the two groups (13vPnC - 7vPnC) at ≥15 IU/mL threshold was calculated.||6.9|-4.4|
72591680|NCT00373958|144714369|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|4.8||||||95.0|-3.4|13.0||||||For Varicella the difference in percentage between the two groups (13vPnC - 7vPnC) at ≥1.09 I.V. threshold was calculated.||13.0|-3.4|
72591681|NCT00373958|144714370|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|0.94||||||95.0|0.75|1.17||||||For Haemophilus influenzae type b (PRP) the GMC ratio (13vPnC/7vPnC) was calculated||1.17|0.75|
72591682|NCT00373958|144714371|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|0.96|||||TWO_SIDED|95.0|0.85|1.08||||||For Measles the GMC ratio (13vPnC/7vPnC) was calculated||1.08|0.85|
72591683|NCT00373958|144714371|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|1.0|||||TWO_SIDED|95.0|0.87|1.14||||||For Mumps the GMC ratio (13vPnC/7vPnC) was calculated||1.14|0.87|
72591684|NCT00373958|144714371|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|1.01|||||TWO_SIDED|95.0|0.92|1.1||||||For Varicella the GMC ratio (13vPnC/7vPnC) was calculated||1.10|0.92|
72591685|NCT00373958|144714372|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|0.78|||||TWO_SIDED|95.0|0.62|1.0||||||For Rubella the GMC ratio (13vPnC/7vPnC) was calculated||1.00|0.62|
72591686|NCT03421145|144714377|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
72591687|NCT03421145|144714378|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
72591688|NCT03421145|144714379|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
72591689|NCT03421145|144714380|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
72591690|NCT03421145|144714381|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
72591691|NCT02105246|144714387|EQUIVALENCE|This analysis compared the proportion of eligible patients who participated in cardiac rehab after referral to home-based vs. referral to center-based programs.|Risk Ratio (RR)|0.98||||0.8|TWO_SIDED||||||Chi-squared|||Null hypothesis = no difference in proportion of patients who participate in cardiac rehab after referral to home-based vs. facility-based programs||||0.80
72591692|NCT02105246|144714388|NON_INFERIORITY|This analysis compared Baseline to 3-month change in 6-minute walk test distance among subjects who participated in home-based cardiac rehab vs. subjects who participated in center-based cardiac rehab|Median Difference (Final Values)|196.0|||<|0.001|TWO_SIDED|||||This comparison was unadjusted.|Wilcoxon (Mann-Whitney)|||Null hypothesis: 3-month change in 6MWT distance is not inferior among participants enrolled in home-based vs. facility-based cardiac rehab.||||<0.001
72414471|NCT00907153|144338529|SUPERIORITY||Mean Difference (Net)|-3.65||||0.48|TWO_SIDED|95.0|-14.32|7.02|||Regression, Linear|Model-based differences adjusted for oral contraceptive use and season.||||7.02|-14.32|0.48
72414472|NCT00907153|144338530|SUPERIORITY||Mean Difference (Net)|-6.51||||0.02|TWO_SIDED|95.0|-12.07|-0.96|||Regression, Linear|Model-based differences adjusted for oral contraceptive use and season.||||-0.96|-12.07|0.02
72414473|NCT00907153|144338531|SUPERIORITY||Mean Difference (Net)|6.28||||0.22|TWO_SIDED|95.0|-3.97|16.54|||Regression, Linear|Model-based differences adjusted for oral contraceptive use and season.||||16.54|-3.97|0.22
72414474|NCT00907153|144338532|SUPERIORITY||Mean Difference (Net)|13.84||||0.33|TWO_SIDED|95.0|-210.29|37.98|||Regression, Linear|Model-based differences adjusted for oral contraceptive use and season.||||37.98|-210.29|0.33
72414475|NCT00907153|144338533|SUPERIORITY||Mean Difference (Net)|-12.8||||0.39|TWO_SIDED|95.0|-42.94|17.34|||Regression, Linear|Model-based differences adjusted for oral contraceptive use and season.||||17.34|-42.94|0.39
72591693|NCT02105246|144714389|NON_INFERIORITY|This analysis compared 6-month change in 6-minute walk test distance among subjects who participated in home-based vs. center-based cardiac rehab.|Median Difference (Final Values)|159.0||||0.03|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: 6-month change in 6MWT distance is not inferior among participants enrolled in home-based vs. facility-based cardiac rehab.||||0.03
72591694|NCT04257032|144714400|OTHER||Ratio of geometric means (T/R) %|105.37|||||TWO_SIDED|90.0|97.94|113.35|||ANOVA|ANOVA model on the logarithmic scale, considering the effects 'sequence', 'period' and 'treatment' as fixed and 'subjects within sequences' as random.|Intra-individual coefficient of variation (gCV %) = 9.9|Relative bioavailability||113.35|97.94|
72591695|NCT04257032|144714401|OTHER||Ratio of geometric means (T/R) %|114.5|||||TWO_SIDED|90.0|104.22|125.81|||ANOVA|ANOVA model on the logarithmic scale, considering the effects 'sequence', 'period' and 'treatment' as fixed and 'subjects within sequences' as random.|Intra-individual coefficient of variation (gCV %) = 14.0|Relative bioavailability||125.81|104.22|
72591696|NCT04257032|144714402|OTHER||Ratio of geometric means (T/R) %|108.18|||||TWO_SIDED|90.0|100.26|116.73|||ANOVA|ANOVA model on the logarithmic scale, considering the effects 'sequence', 'period' and 'treatment' as fixed and 'subjects within sequences' as random.|Intra-individual coefficient of variation (gCV %) = 11.3|Relative bioavailability||116.73|100.26|
72591697|NCT04257032|144714403|OTHER||Ratio of geometric means (T/R) %|108.89|||||TWO_SIDED|90.0|99.84|118.76|||ANOVA|ANOVA model on the logarithmic scale, considering the effects 'sequence', 'period' and 'treatment' as fixed and 'subjects within sequences' as random.|Intra-individual coefficient of variation (gCV %) = 12.9|Relative bioavailability||118.76|99.84|
72591698|NCT04257032|144714404|OTHER||Ratio of geometric means (T/R) %|104.52|||||TWO_SIDED|90.0|97.34|112.23|||ANOVA|ANOVA model on the logarithmic scale, considering the effects 'sequence', 'period' and 'treatment' as fixed and 'subjects within sequences' as random.|Intra-individual coefficient of variation (gCV %) = 10.6|Relative bioavailability||112.23|97.34|
72591699|NCT04257032|144714405|OTHER||Ratio of geometric means (T/R) %|108.42|||||TWO_SIDED|90.0|100.37|117.12|||ANOVA|ANOVA model on the logarithmic scale, considering the effects 'sequence', 'period' and 'treatment' as fixed and 'subjects within sequences' as random.|Intra-individual coefficient of variation (gCV %) = 11.5|Relative bioavailability||117.12|100.37|
72591700|NCT03626363|144714417|SUPERIORITY|We sought to have up to 20 participants complete each group so that we could have a statistical power of 0.89 to detect about a 4 burst per minute difference with an alpha of 0.05. We would have had sympathetic nerve data on up to 18 more of the 21 participants that we were not allowed to post-test in the spring of 2020 due to COVID-19 restrictions.|Mean Difference (Net)|-2.0||||0.51|TWO_SIDED||||||ANOVA|||Repeated measures analysis of variance with 2 groups (MBSR and SME) and 2 time points (Pre vs. Post). Outcome data reported is the change in the mean number of bursts per minute of muscle sympathetic nerve activity (MSNA) from pre to post.||||0.51
72414476|NCT00907153|144338534|SUPERIORITY||Mean Difference (Net)|-75.08||||0.09|TWO_SIDED|95.0|-161.9|11.78|||Regression, Linear|Model-based differences adjusted for oral contraceptive use and season.||||11.78|-161.9|0.09
72414477|NCT00907153|144338535|SUPERIORITY||Mean Difference (Net)|0.73||||0.96|TWO_SIDED|95.0|-32.59|34.06|||Regression, Linear|Model-based differences adjusted for oral contraceptive use and season.||||34.06|-32.59|0.96
72414478|NCT00907153|144338536|SUPERIORITY||Mean Difference (Net)|3.08||||0.21|TWO_SIDED|95.0|-1.84|7.99|||Regression, Linear|Model-based differences adjusted for oral contraceptive use and season.||||7.99|-1.84|0.21
72591701|NCT03626363|144714418|SUPERIORITY|To detect a 0.5 meter per second change in carotid-to-femoral pulse wave velocity with at least 80% power with an alpha of 0.05 we should have had at least 12 participants complete measurements in each group (MBSR and SME). We fell a little short of that in the MBSR group and met the 12 participants in the SME group. The number of participants we were able to study from pre to post was limited by COVID-19 restrictions.|Mean Difference (Net)|-0.2||||0.25|TWO_SIDED||||||ANOVA|||Repeated measures analysis of variance with 2 groups (MBSR and SME) and 2 time points (Pre vs. Post). Outcome data reported is the change in carotid-to-femoral pulse wave velocity in meters per second from pre to post. We had 21 participants in the spring of 2020 that were were not allowed to bring into the laboratory for post testing during COVID-19 restrictions which led to our limited sample size.||||0.25
72591702|NCT06366087|144714484|OTHER|Estimation only. Estimates are back-transformed and based on a random effects linear model with log10 numeric response variable, adjusting for study route received, dosing sequence, and period, with a random effect for subject nested within dosing sequence.|Ratio of geometric least-square means|0.7|||||TWO_SIDED|90.0|0.67|0.724|||Mixed Models Analysis||Bioequivalence will be considered met if the 90% CI of the ratio for AUCinf lies within 80.00 to 125.00%.|||0.724|0.670|
72591703|NCT06366087|144714485|OTHER|Estimation only. Estimates are back-transformed and based on a random effects linear model with log10 numeric response variable, adjusting for study route received, dosing sequence, and period, with a random effect for subject nested within dosing sequence.|Ratio of geometric least-square means|0.67|||||TWO_SIDED|90.0|0.64|0.697|||Mixed Models Analysis||Bioequivalence will be considered met if the 90% CI of the ratio for AUCt lies within 80.00 to 125.00%.|||0.697|0.640|
72591704|NCT06366087|144714486|OTHER|Estimation only. Estimates are back-transformed and based on a random effects linear model with log10 numeric response variable, adjusting for study route received, dosing sequence, and period, with a random effect for subject nested within dosing sequence.|Ratio of geometric least-square means|0.11|||||TWO_SIDED|90.0|0.088|0.136|||Mixed Models Analysis|||||0.136|0.088|
72591705|NCT06366087|144714487|OTHER|Estimation only. Estimates are back-transformed and based on a random effects linear model with log10 numeric response variable, adjusting for study route received, dosing sequence, and period, with a random effect for subject nested within dosing sequence.|Ratio of geometric least-square means|0.15|||||TWO_SIDED|90.0|0.12|0.189|||Mixed Models Analysis|||||0.189|0.120|
72591706|NCT06366087|144714488|OTHER|Estimation only. Estimates are back-transformed and based on a random effects linear model with log10 numeric response variable, adjusting for study route received, dosing sequence, and period, with a random effect for subject nested within dosing sequence.|Ratio of geometric least-square means|0.26|||||TWO_SIDED|90.0|0.217|0.309|||Mixed Models Analysis|||||0.309|0.217|
72591707|NCT06366087|144714489|OTHER|Estimation only. Estimates are back-transformed and based on a random effects linear model with log10 numeric response variable, adjusting for study route received, dosing sequence, and period, with a random effect for subject nested within dosing sequence.|Ratio of geometric least-square means|0.36|||||TWO_SIDED|90.0|0.318|0.416|||Mixed Models Analysis|||||0.416|0.318|
72591708|NCT06366087|144714490|OTHER|Estimation only. Estimates are back-transformed and based on a random effects linear model with log10 numeric response variable, adjusting for study route received, dosing sequence, and period, with a random effect for subject nested within dosing sequence.|Ratio of geometric least-square means|0.44|||||TWO_SIDED|90.0|0.396|0.492|||Mixed Models Analysis|||||0.492|0.396|
72591709|NCT06366087|144714491|OTHER|Estimation only. Estimates are back-transformed and based on a random effects linear model with log10 numeric response variable, adjusting for study route received, dosing sequence, and period, with a random effect for subject nested within dosing sequence.|Ratio of geometric least-square means|0.57|||||TWO_SIDED|90.0|0.532|0.608|||Mixed Models Analysis|||||0.608|0.532|
72591710|NCT06366087|144714492|OTHER|Estimation only. Estimates are back-transformed and based on a random effects linear model with log10 numeric response variable, adjusting for study route received, dosing sequence, and period, with a random effect for subject nested within dosing sequence.|Ratio of geometric least-square means|0.57|||||TWO_SIDED|90.0|0.524|0.62|||Mixed Models Analysis|||||0.620|0.524|
72591711|NCT00860249|144714514|SUPERIORITY_OR_OTHER||||||<|0.017||95.0||||We used the Bonferroni calculation to adjust for the planned multiple comparisons among the three groups.|Chi-squared|||Please note that no analyses were performed as the trial was stopped due to low enrollment.||||<0.017
72591712|NCT00860249|144714515|SUPERIORITY_OR_OTHER||||||<|0.017||95.0||||We intended to use a Bonferroni calculation to adjust for multiple comparisons among study arms.|Chi-squared|||Please note that no analyses were performed as the trial was stopped due to low enrollment.||||<0.017
72591713|NCT00174967|144714516|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Pairwise comparisons between placebo and each of the febuxostat treatment groups were performed using Fisher's exact test. Adjustment for multiple comparisons was made using Hochberg's procedure.|Fisher Exact|||||||<0.001
72591714|NCT00174967|144714516|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Pairwise comparisons between placebo and each of the febuxostat treatment groups were performed using Fisher's exact test. Adjustment for multiple comparisons was made using Hochberg's procedure.|Fisher Exact|||||||<0.001
72591715|NCT00174967|144714516|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Pairwise comparisons between placebo and each of the febuxostat treatment groups were performed using Fisher's exact test. Adjustment for multiple comparisons was made using Hochberg's procedure.|Fisher Exact|||||||<0.001
72591716|NCT00174967|144714517|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Pairwise comparisons between placebo and each of the febuxostat treatment groups were performed using Fisher's exact test. Adjustment for multiple comparisons was made using Hochberg's procedure.|Fisher Exact|||||||<0.001
72591717|NCT00174967|144714517|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Pairwise comparisons between placebo and each of the febuxostat treatment groups were performed using Fisher's exact test. Adjustment for multiple comparisons was made using Hochberg's procedure.|Fisher Exact|||||||<0.001
72591718|NCT00174967|144714517|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Pairwise comparisons between placebo and each of the febuxostat treatment groups were performed using Fisher's exact test. Adjustment for multiple comparisons was made using Hochberg's procedure.|Fisher Exact|||||||<0.001
72591719|NCT00174967|144714518|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Pairwise comparisons between placebo and each of the febuxostat treatment groups were performed using Fisher's exact test. Adjustment for multiple comparisons was made using Hochberg's procedure.|Fisher Exact|||||||<0.001
72591720|NCT00174967|144714518|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Pairwise comparisons between placebo and each of the febuxostat treatment groups were performed using Fisher's exact test. Adjustment for multiple comparisons was made using Hochberg's procedure.|Fisher Exact|||||||<0.001
72591721|NCT00174967|144714518|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Pairwise comparisons between placebo and each of the febuxostat treatment groups were performed using Fisher's exact test. Adjustment for multiple comparisons was made using Hochberg's procedure.|Fisher Exact|||||||<0.001
72591722|NCT00174967|144714519|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Pairwise comparisons between placebo and each of the febuxostat treatment groups were performed using Fisher's exact test. Adjustment for multiple comparisons was made using Hochberg's procedure.|Fisher Exact|||||||<0.001
72591723|NCT00174967|144714519|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Pairwise comparisons between placebo and each of the febuxostat treatment groups were performed using Fisher's exact test. Adjustment for multiple comparisons was made using Hochberg's procedure.|Fisher Exact|||||||<0.001
72591724|NCT00174967|144714519|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Pairwise comparisons between placebo and each of the febuxostat treatment groups were performed using Fisher's exact test. Adjustment for multiple comparisons was made using Hochberg's procedure.|Fisher Exact|||||||<0.001
72591725|NCT00174967|144714520|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Pairwise comparisons between placebo and each of the febuxostat treatment groups were performed using a t-test. Adjustment for multiple comparisons was made using Hochberg's procedure.|t-test, 2 sided|||||||<0.001
72591726|NCT00174967|144714520|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Pairwise comparisons between placebo and each of the febuxostat treatment groups were performed using a t-test. Adjustment for multiple comparisons was made using Hochberg's procedure.|t-test, 2 sided|||||||<0.001
72591727|NCT00174967|144714520|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Pairwise comparisons between placebo and each of the febuxostat treatment groups were performed using a t-test. Adjustment for multiple comparisons was made using Hochberg's procedure.|t-test, 2 sided|||||||<0.001
72591728|NCT00174967|144714521|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Pairwise comparisons between placebo and each of the febuxostat treatment groups were performed using a t-test. Adjustment for multiple comparisons was made using Hochberg's procedure.|t-test, 2 sided|||||||<0.001
72591729|NCT00174967|144714521|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Pairwise comparisons between placebo and each of the febuxostat treatment groups were performed using a t-test. Adjustment for multiple comparisons was made using Hochberg's procedure.|t-test, 2 sided|||||||<0.001
72591730|NCT00174967|144714521|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Pairwise comparisons between placebo and each of the febuxostat treatment groups were performed using a t-test. Adjustment for multiple comparisons was made using Hochberg's procedure.|t-test, 2 sided|||||||<0.001
72414479|NCT00907153|144338537|SUPERIORITY||Mean Difference (Net)|0.11||||0.99|TWO_SIDED|95.0|-24.43|24.64|||Regression, Linear|Model-based differences adjusted for oral contraceptive use and season.||||24.64|-24.43|0.99
72591731|NCT00174967|144714522|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Pairwise comparisons between placebo and each of the febuxostat treatment groups were performed using a t-test. Adjustment for multiple comparisons was made using Hochberg's procedure.|t-test, 2 sided|||||||<0.001
72591732|NCT00174967|144714522|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Pairwise comparisons between placebo and each of the febuxostat treatment groups were performed using a t-test. Adjustment for multiple comparisons was made using Hochberg's procedure.|t-test, 2 sided|||||||<0.001
72414480|NCT00907153|144338538|SUPERIORITY||Median Difference (Net)|-1.93||||0.62|TWO_SIDED|95.0|-10.12|6.26|||Regression, Linear|Model-based differences adjusted for oral contraceptive use and season.||||6.26|-10.12|0.62
72414481|NCT00907153|144338539|SUPERIORITY||Mean Difference (Net)|0.28||||0.98|TWO_SIDED|95.0|-20.29|20.85|||Regression, Linear|Model-based differences adjusted for oral contraceptive use and season.||||20.85|-20.29|0.98
72591733|NCT00174967|144714522|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Pairwise comparisons between placebo and each of the febuxostat treatment groups were performed using a t-test. Adjustment for multiple comparisons was made using Hochberg's procedure.|t-test, 2 sided|||||||<0.001
72591734|NCT00174967|144714523|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Pairwise comparisons between placebo and each of the febuxostat treatment groups were performed using a t-test. Adjustment for multiple comparisons was made using Hochberg's procedure.|t-test, 2 sided|||||||<0.001
72591735|NCT00174967|144714523|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Pairwise comparisons between placebo and each of the febuxostat treatment groups were performed using a t-test. Adjustment for multiple comparisons was made using Hochberg's procedure.|t-test, 2 sided|||||||<0.001
72591736|NCT00174967|144714523|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Pairwise comparisons between placebo and each of the febuxostat treatment groups were performed using a t-test. Adjustment for multiple comparisons was made using Hochberg's procedure.|t-test, 2 sided|||||||<0.001
72414482|NCT00907153|144338540|SUPERIORITY||Mean Difference (Net)|10.24||||0.64|TWO_SIDED|95.0|-34.61|55.08|||Regression, Linear|Model-based differences adjusted for oral contraceptive use and season.||||55.08|-34.61|0.64
72591737|NCT00174967|144714524|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Pairwise comparisons between placebo and each of the febuxostat treatment groups were performed using a t-test. Adjustment for multiple comparisons was made using Hochberg's procedure.|t-test, 2 sided|||||||<0.001
72591738|NCT00174967|144714524|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Pairwise comparisons between placebo and each of the febuxostat treatment groups were performed using a t-test. Adjustment for multiple comparisons was made using Hochberg's procedure.|t-test, 2 sided|||||||<0.001
72414483|NCT00907153|144338541|SUPERIORITY||Mean Difference (Net)|0.88||||0.88|TWO_SIDED|95.0|-22.81|8.51|||Regression, Linear|Model-based differences adjusted for oral contraceptive use and season.||||8.51|-22.81|0.88
72414484|NCT00907153|144338542|SUPERIORITY||Mean Difference (Net)|-3.15||||0.25|TWO_SIDED|95.0|-8.7|2.41|||Regression, Linear|Model-based differences adjusted for oral contraceptive use and season.||||2.41|-8.70|0.25
72414485|NCT00907153|144338543|SUPERIORITY||Mean Difference (Net)|44.31|||<|0.001|TWO_SIDED|95.0|27.13|61.48|||Regression, Linear|Model-based differences adjusted for oral contraceptive use and season.||||61.48|27.13|<0.001
72591739|NCT00174967|144714524|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Pairwise comparisons between placebo and each of the febuxostat treatment groups were performed using a t-test. Adjustment for multiple comparisons was made using Hochberg's procedure.|t-test, 2 sided|||||||<0.001
72591740|NCT00174967|144714525|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Pairwise comparisons between placebo and each of the febuxostat treatment groups were performed using a t-test. Adjustment for multiple comparisons was made using Hochberg's procedure.|t-test, 2 sided|||||||<0.001
72591741|NCT00174967|144714525|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Pairwise comparisons between placebo and each of the febuxostat treatment groups were performed using a t-test. Adjustment for multiple comparisons was made using Hochberg's procedure.|t-test, 2 sided|||||||<0.001
72591742|NCT00174967|144714525|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Pairwise comparisons between placebo and each of the febuxostat treatment groups were performed using a t-test. Adjustment for multiple comparisons was made using Hochberg's procedure.|t-test, 2 sided|||||||<0.001
72591743|NCT02031640|144714526|SUPERIORITY||Least Square Mean (LSM) Difference|0.034||||0.272|TWO_SIDED|95.0|-0.027|0.095|||ANCOVA|||||0.095|-0.027|0.272
72591744|NCT02031640|144714526|SUPERIORITY||LSM Difference|0.045||||0.1415|TWO_SIDED|95.0|-0.015|0.106|||ANCOVA|||||0.106|-0.015|0.1415
72591745|NCT02031640|144714526|SUPERIORITY||LSM Difference|-0.015||||0.6356|TWO_SIDED|95.0|-0.075|0.046|||ANCOVA|||||0.046|-0.075|0.6356
72414486|NCT00907153|144338544|SUPERIORITY||Mean Difference (Net)|1.56||||0.38|TWO_SIDED|95.0|-2.08|5.2|||Regression, Linear|Model-based differences adjusted for oral contraceptive use and season.||||5.20|-2.08|0.38
72591746|NCT02031640|144714526|SUPERIORITY||LSM Difference|0.04||||0.1932|TWO_SIDED|95.0|-0.02|0.1|||ANCOVA|||||0.1|-0.02|0.1932
72591747|NCT02031640|144714527|OTHER|The analysis of change from baseline in weekly average of daily trough morning (pre-dose and pre-rescue bronchodilator) PEF over the 12-week treatment period was performed using a repeated measures mixed model with effects due to baseline weekly average of daily trough morning PEF, sex, age, treatment, time, and time-by-treatment interaction.|LSM Difference|10.616||||0.0036|TWO_SIDED|95.0|3.489|17.744|||Mixed Model for repeated measures|||||17.744|3.489|0.0036
72591748|NCT02031640|144714527|SUPERIORITY||LSM Difference|8.419||||0.0204|TWO_SIDED|95.0|1.309|15.53|||Mixed Model for repeated measures|||The analysis of change from baseline in weekly average of daily trough morning (pre-dose and pre-rescue bronchodilator) PEF over the 12-week treatment period was performed using a repeated measures mixed model with effects due to baseline weekly average of daily trough morning PEF, sex, age, treatment, time, and time-by-treatment interaction||15.53|1.309|0.0204
72591749|NCT02031640|144714527|SUPERIORITY||LSM Difference|6.004||||0.0984|TWO_SIDED|95.0|-1.121|13.129|||Mixed Model for repeated measures|||The analysis of change from baseline in weekly average of daily trough morning (pre-dose and pre-rescue bronchodilator) PEF over the 12-week treatment period was performed using a repeated measures mixed model with effects due to baseline weekly average of daily trough morning PEF, sex, age, treatment, time, and time-by-treatment interaction||13.129|-1.121|0.0984
72591750|NCT02031640|144714527|SUPERIORITY||LSM Difference|12.512||||0.0006|TWO_SIDED|95.0|5.435|19.589|||Mixed Model for repeated measures|||The analysis of change from baseline in weekly average of daily trough morning (pre-dose and pre-rescue bronchodilator) PEF over the 12-week treatment period was performed using a repeated measures mixed model with effects due to baseline weekly average of daily trough morning PEF, sex, age, treatment, time, and time-by-treatment interaction||19.589|5.435|0.0006
72591751|NCT02031640|144714528|SUPERIORITY||LSM Difference|9.147||||0.0139|TWO_SIDED|95.0|1.866|16.429|||Mixed Model for repeated measures|||||16.429|1.866|0.0139
72591752|NCT02031640|144714528|SUPERIORITY||LSM Difference|9.17||||0.0133|TWO_SIDED|95.0|1.914|16.425|||Mixed Model for repeated measures|||||16.425|1.914|0.0133
72591753|NCT02031640|144714528|SUPERIORITY||LSM Difference|4.088||||0.2704|TWO_SIDED|95.0|-3.191|11.367|||Mixed Model for repeated measures|||||11.367|-3.191|0.2704
72591754|NCT02031640|144714528|SUPERIORITY||LSM Difference|10.301||||0.0053|TWO_SIDED|95.0|3.073|17.53|||Mixed Model for repeated measures|||||17.53|3.073|0.0053
72591755|NCT02031640|144714529|SUPERIORITY||LSM Difference|-0.703|||<|0.0001|TWO_SIDED|95.0|-1.044|-0.363|||Mixed Model for repeated measures|||||-0.363|-1.044|<0.0001
72591756|NCT02031640|144714529|SUPERIORITY||LSM Difference|-0.691|||<|0.0001|TWO_SIDED|95.0|-1.029|-0.352|||Mixed Model for repeated measures|||||-0.352|-1.029|<0.0001
72591757|NCT02031640|144714529|SUPERIORITY||LSM Difference|-0.651||||0.0002|TWO_SIDED|95.0|-0.994|-0.309|||Mixed Model for repeated measures|||||-0.309|-0.994|0.0002
72591758|NCT02031640|144714529|SUPERIORITY||LSM difference|-0.801|||<|0.0001|TWO_SIDED|95.0|-1.138|-0.464|||Mixed Model for repeated measures|||||-0.464|-1.138|<0.0001
72414487|NCT00907153|144338545|SUPERIORITY||Mean Difference (Net)|-7.84||||0.46|TWO_SIDED|95.0|-29.34|13.67|||Regression, Linear|Model-based differences adjusted for oral contraceptive use and season.||||13.67|-29.34|0.46
72591759|NCT02031640|144714530|SUPERIORITY||Mean Difference (Final Values)|-0.149||||0.0119|TWO_SIDED|95.0|-0.265|-0.033|||Mixed Models Analysis|||||-0.033|-0.265|0.0119
72591760|NCT02031640|144714530|SUPERIORITY||Mean Difference (Final Values)|-0.102||||0.0854|TWO_SIDED|95.0|-0.217|0.014|||Mixed Models Analysis|||||0.014|-0.217|0.0854
72591761|NCT02031640|144714530|SUPERIORITY||Mean Difference (Final Values)|-0.189||||0.0016|TWO_SIDED|95.0|-0.306|-0.072|||Mixed Models Analysis|||||-0.072|-0.306|0.0016
72591762|NCT02031640|144714530|SUPERIORITY||Mean Difference (Final Values)|-0.216||||0.0003|TWO_SIDED|95.0|-0.332|-0.101|||Mixed Models Analysis|||||-0.101|-0.332|0.0003
72591763|NCT05356533|144714538|SUPERIORITY||Risk Ratio (RR)|1.08|||>|0.05|TWO_SIDED||||||Mixed Models Analysis|||||||>.05
72591764|NCT05356533|144714538|SUPERIORITY||Risk Ratio (RR)|1.08|||>|0.05|TWO_SIDED||||||ANOVA|||||||>.05
72591765|NCT05356533|144714539|SUPERIORITY||Risk Ratio (RR)|1.08|||>|0.05|TWO_SIDED||||||Mixed Models Analysis|||||||>.05
72591766|NCT05356533|144714540|SUPERIORITY||Risk Ratio (RR)|0.81|||>|0.05|TWO_SIDED||||||Mixed Models Analysis|||||||>.05
72591767|NCT05356533|144714541|SUPERIORITY||Risk Ratio (RR)|0.91|||<|0.05|TWO_SIDED||||||Mixed Models Analysis|||||||<.05
72591768|NCT05356533|144714542|SUPERIORITY||Risk Ratio (RR)|0.99|||>|0.05|TWO_SIDED||||||Mixed Models Analysis|||||||>.05
72591769|NCT05356533|144714543|SUPERIORITY||Risk Ratio (RR)|1.11|||>|0.05|TWO_SIDED||||||Mixed Models Analysis|||||||>.05
72591770|NCT01279070|144714544|SUPERIORITY_OR_OTHER||Effect size|0.43|||<|0.05|TWO_SIDED|95.0|0.1|0.7|||Mixed Models Analysis||In all the models,adjusted mean difference between the two groups,standardized treatment effect (ES) and confidence intervals were calculated.All the estimates obtained with these models remain unbiased under the missing at random (MAR)assumption.|To evaluate intervention efficacy on the BADS(Total score and Key search subtest),linear mixed-effects models were fitted using Restricted Maximum Likelihood (REML.An unstructured correlation matrix was used to account for correlation among several observations for each subject.The dependent variable comprised the measures at 16 weeks while the baseline value of the BADS,intervention group(REPYFLEC group vs Leisure group),time and the interaction term (time×treatment)were included as covariates.||0.7|0.1|<0.05
72591771|NCT01279070|144714545|SUPERIORITY_OR_OTHER||Effect Size|0.42|||<|0.05|TWO_SIDED|95.0|0.1|0.7|||Mixed Models Analysis||In all the models,adjusted mean difference between the two groups,standardized treatment effect (ES) and confidence intervals were calculated.All the estimates obtained with these models remain unbiased under the missing at random (MAR)assumption.|To evaluate intervention efficacy on the BADS(Total score and Key search subtest),linear mixed-effects models were fitted using Restricted Maximum Likelihood(REML).An unstructured correlation matrix was used to account for correlation among several observations for each subject.The dependent variable comprised the measures at 40 weeks while the baseline value of the BADS,intervention group(REPYFLEC group vs Leisure group),time and the interaction term (time×treatment)were included as covariates.||0.7|0.1|<0.05
72591772|NCT01279070|144714546|SUPERIORITY_OR_OTHER||Effect Size|0.33|||<|0.05|TWO_SIDED|95.0|0.06|0.6|||Mixed Models Analysis||In all the models,adjusted mean difference between the two groups,standardized treatment effect (ES) and confidence intervals were calculated.All the estimates obtained with these models remain unbiased under the missing at random (MAR)assumption.|To evaluate intervention efficacy on the LSP, linear mixed-effects models were fitted using Restricted Maximum Likelihood (REML). An unstructured correlation matrix was used to account for correlation among several observations for each subject. The dependent variable comprised the measures at 16 weeks while the baseline value of the LSP, intervention group (REPYFLEC group vs Leisure group), time and the interaction term (time×treatment) were included as covariates.||0.6|0.06|<0.05
72591773|NCT01279070|144714547|SUPERIORITY_OR_OTHER||Effect Size|0.35|||<|0.05|TWO_SIDED|95.0|0.09|0.6|||Mixed Models Analysis||In all the models,adjusted mean difference between the two groups,standardized treatment effect (ES) and confidence intervals were calculated.All the estimates obtained with these models remain unbiased under the missing at random (MAR)assumption.|To evaluate intervention efficacy on the LSP, linear mixed-effects models were fitted using Restricted Maximum Likelihood (REML). An unstructured correlation matrix was used to account for correlation among several observations for each subject. The dependent variable comprised the measures at 40 weeks while the baseline value of the LSP, intervention group (REPYFLEC group vs Leisure group), time and the interaction term (time×treatment) were included as covariates.||0.6|0.09|<0.05
72591774|NCT01279070|144714548|SUPERIORITY_OR_OTHER||Effect Size|0.3|||<|0.05|TWO_SIDED|95.0|0.01|0.7|||Mixed Models Analysis||In all the models,adjusted mean difference between the two groups,standardized treatment effect (ES) and confidence intervals were calculated.All the estimates obtained with these models remain unbiased under the missing at random (MAR)assumption.|To evaluate intervention efficacy on the PANSS, linear mixed-effects models were fitted using Restricted Maximum Likelihood (REML). An unstructured correlation matrix was used to account for correlation among several observations for each subject. The dependent variable comprised the measures at 16 weeks while the baseline value of the PANSS, intervention group (REPYFLEC group vs Leisure group), time and the interaction term (time×treatment) were included as covariates.||0.7|0.01|<0.05
72591775|NCT01279070|144714549|SUPERIORITY_OR_OTHER||Effect Size|0.3|||<|0.05|TWO_SIDED|95.0|0.01|0.7|||Mixed Models Analysis||In all the models,adjusted mean difference between the two groups, standardized treatment effect (ES) and confidence intervals were calculated.All the estimates obtained with these models remain unbiased under the missing at random (MAR) assumption.|To evaluate intervention efficacy on the PANSS, linear mixed-effects models were fitted using Restricted Maximum Likelihood (REML). An unstructured correlation matrix was used to account for correlation among several observations for each subject. The dependent variable comprised the measures at 40 weeks while the baseline value of the PANSS, intervention group (REPYFLEC group vs Leisure group), time and the interaction term (time×treatment) were included as covariates.||0.7|0.01|<0.05
72591776|NCT05139303|144714550|OTHER||||||<|0.05|||||||Chi-squared|||||||<0.05
72591777|NCT02822573|144714554|SUPERIORITY|Mixed effects repeated measures analysis of covariance (RMANCOVA) models with covariates of treatment, time, time by treatment interaction, baseline outcome level, age stratification and an unstructured covariance matrix. The primary objective was assessed using a linear contrast of group effect at 24 weeks.||||||0.32|||||||ANCOVA|||With a sample size of 266, there was 90% power to detect a treatment difference of 2 words for HVLT-R total recall score (SD=4.26, effect size=0.47) with a two-sided 5% level of significance. This calculation assumed an ANCOVA model analysis with 25% dropout and 2% missing data at end of treatment. A single interim analysis for futility occurred after 138 participants, with stopping rule of two-sided p-value \< 0.0154. This design required 3.5% more than fixed design, increasing total to 276.||||0.32
72591778|NCT02275780|144714561|NON_INFERIORITY|Doravirine is concluded to be non-inferior to darunavir + ritonavir if the lower bound of the 95% CI for the difference in percent response is above -10 percentage points.|Treatment Difference|3.913|||||TWO_SIDED|95.0|-1.59|9.415|||||Stratum-adjusted Mantel-Haenszel method with the difference weighted by the harmonic mean of sample size per arm for each stratum.|||9.415|-1.590|
72591779|NCT02275780|144714562|NON_INFERIORITY|Doravirine is concluded to be non-inferior to darunavir + ritonavir if the lower bound of the 95% CI for the difference in percent response is above -10 percentage points.|Treatment Difference|7.082|||||TWO_SIDED|95.0|0.508|13.656|||||Stratum-adjusted Mantel-Haenszel method with the difference weighted by the harmonic mean of sample size per arm for each stratum.|||13.656|0.508|
72591780|NCT02275780|144714563|OTHER||Mean treatment difference|7.1|||||TWO_SIDED|95.0|-20.8|35.0|||||Stratum-adjusted Mantel-Haenszel method with the difference weighted by the harmonic mean of sample size per arm for each stratum.|||35.0|-20.8|
72591781|NCT02275780|144714564|OTHER||Mean treatment difference|17.4|||||TWO_SIDED|95.0|-14.5|49.3|||||Stratum-adjusted Mantel-Haenszel method with the difference weighted by the harmonic mean of sample size per arm for each stratum.|||49.3|-14.5|
72591782|NCT02275780|144714565|OTHER||Treatment Difference (mg/dL)|-14.61|||<|0.0001|TWO_SIDED|95.0|-18.15|-11.06|||ANCOVA|Terms for Baseline lipid level and treatment group||||-11.06|-18.15|<0.0001
72591783|NCT02275780|144714566|OTHER||Treatment Difference (mg/dL)|-19.34|||<|0.0001|TWO_SIDED|95.0|-23.33|-15.35|||ANCOVA|Terms for Baseline lipid level and treatment group||||-15.35|-23.33|<0.0001
72591784|NCT02275780|144714575|OTHER||Treatment Difference|4.169|||||TWO_SIDED|95.0|-1.404|9.743|||||Stratum-adjusted Mantel-Haenszel method with the difference weighted by the harmonic mean of sample size per arm for each stratum.|||9.743|-1.404|
72591785|NCT02275780|144714576|OTHER||Treatment Difference|7.606|||||TWO_SIDED|95.0|0.98|14.232|||||Stratum-adjusted Mantel-Haenszel method with the difference weighted by the harmonic mean of sample size per arm for each stratum.|||14.232|0.980|
72591786|NCT03960866|144714577|SUPERIORITY||Mean Difference (Net)|0.12||||0.89|TWO_SIDED||||||t-test, 2 sided|||||||0.89
72591787|NCT01646021|144714635|OTHER||Hazard Ratio (HR)|0.45|||<|0.0001|TWO_SIDED|95.0|0.35|0.6|||Log Rank|||||0.60|0.35|< 0.0001
72591788|NCT01646021|144714637|SUPERIORITY||Hazard Ratio (HR)|0.74|||=|0.0621|TWO_SIDED|95.0|0.54|1.02|||Log Rank|||||1.02|0.54|= 0.0621
72591789|NCT01663779|144714684|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.0|||<|0.01|TWO_SIDED|95.0|3.0|7.0|||Chi-squared|||||7|3|<0.01
72591790|NCT05845567|144714694|SUPERIORITY||ratio of the Geometric LSmeans|139.43|||||TWO_SIDED|90.0|129.73|149.86||||||||149.86|129.73|
72591791|NCT05845567|144714695|SUPERIORITY||ratio of the Geometric LSmeans|117.97|||||TWO_SIDED|90.0|112.24|124.0||||||||124.00|112.24|
72591792|NCT05845567|144714696|SUPERIORITY||ratio of the Geometric LSmeans|117.88|||||TWO_SIDED|90.0|112.13|123.92||||||||123.92|112.13|
72591793|NCT03409107|144714705|SUPERIORITY||LS Mean Difference|1.4|||<|0.0001|TWO_SIDED|95.0|1.23|1.56|||ANCOVA|One-sided p-value based on test of null hypothesis: (Daprodustat - Placebo) \<= 0 versus alternative: difference \> 0.|Treatment group comparisons were based on a ANCOVA model with terms for treatment, Baseline hemoglobin, and region.|||1.56|1.23|<0.0001
72591794|NCT03409107|144714706|SUPERIORITY||Difference in Response rate|0.56|||<|0.0001|TWO_SIDED|95.0|0.49|0.63||One-sided p-value was based on test of null hypothesis: (Daprodustat - Placebo) \<=0 versus alternative: difference \> 0|Cochran-Mantel-Haenszel||Treatment group comparisons were based on a Cochran-Mantel-Haenszel test adjusted for treatment group and region.|||0.63|0.49|<0.0001
72591795|NCT03409107|144714707|SUPERIORITY||LS Mean Difference|5.36||||0.0005|TWO_SIDED|95.0|2.17|8.56||One-sided p-value based on test of null hypothesis:(Daprodustat-Placebo) \<= 0 vs alternative: difference \> 0.|ANCOVA||Treatment group comparisons were based on ANCOVA model with terms for treatment, Baseline score, and region.|||8.56|2.17|0.0005
72591796|NCT03409107|144714708|SUPERIORITY||Difference in Response rate|0.45|||<|0.0001|TWO_SIDED|95.0|0.37|0.52||One-sided p-value was based on test of null hypothesis: (Daprodustat-Placebo) \<=0 versus alternative: difference \>0.|Cochran-Mantel-Haenszel||Treatment group comparisons are based on a Cochran-Mantel-Haenszel test adjusted for treatment group, and region|||0.52|0.37|<0.0001
72591797|NCT03409107|144714709|SUPERIORITY||Difference in treatment effect|38.8|||||TWO_SIDED|95.0|25.0|54.55|||Hodges-Lehmann Estimate|Hodges-Lehmann Estimate of treatment difference has been reported.||||54.55|25.00|
72591798|NCT03409107|144714710|SUPERIORITY||Difference in treatment effect|0.768|||<|0.0001|TWO_SIDED|95.0|0.729|0.806||One-sided superiority p-value from the van Elteren test|van Elteren test||Mann-Whitney estimate of the treatment difference stratified by region has been presented.|||0.806|0.729|<0.0001
72591799|NCT03409107|144714711|SUPERIORITY||LS Mean difference|1.36|||<|0.0001|TWO_SIDED|95.0|1.16|1.55||One-sided superiority p-value from the MMRM model|MMRM||Treatment group comparisons were based on MMRM fitted from Baseline up to Week 28, with factors for treatment, time, region, Baseline Hb and Baseline Hb by time and treatment by time interactions.|||1.55|1.16|<0.0001
72591800|NCT03409107|144714712|SUPERIORITY||Hazard Ratio (HR)|0.07||||0.0002|TWO_SIDED|95.0|0.02|0.3||One-sided p-value was based on Wald test of null hypothesis: (Daprodustat/Placebo) \>=1 versus alternative: ratio\<1.|Wald test||Hazard ratio was estimated using a Cox proportional hazard regression model adjusted for treatment group and region.|||0.30|0.02|0.0002
72591801|NCT03409107|144714713|SUPERIORITY||Mean Difference (Net)|5.91|||<|0.0001|TWO_SIDED|95.0|2.83|9.0||One-sided p-value was based on test of null hypothesis: (Daprodustat-Placebo) \<=0 versus alternative: difference \>0.|MMRM||Analysis was performed by MMRM with factors for treatment, time, region, Baseline value and Baseline value by time and treatment by time interactions for Tired/Low Energy/Weak domain.|||9.00|2.83|<0.0001
72591802|NCT03409107|144714713|SUPERIORITY||Mean Difference (Net)|2.93||||0.0152|TWO_SIDED|95.0|0.28|5.57||One-sided p-value was based on test of null hypothesis: (Daprodustat-Placebo) \<=0 versus alternative: difference \>0.|MMRM||Analysis was performed by MMRM with factors for treatment, time, region, Baseline value and Baseline value by time and treatment by time interactions for Chest Pain/Shortness of Breath Domain.|||5.57|0.28|0.0152
72591803|NCT03409107|144714713|SUPERIORITY||Mean Difference (Net)|3.79||||0.0045|TWO_SIDED|95.0|0.95|6.63||One-sided p-value was based on test of null hypothesis: (Daprodustat-Placebo) \<=0 versus alternative: difference \>0.|MMRM||Analysis was performed by MMRM with factors for treatment, time, region, Baseline value and Baseline value by time and treatment by time interactions for Cognitive Domain.|||6.63|0.95|0.0045
72591804|NCT03409107|144714713|SUPERIORITY||Mean Difference (Net)|2.61||||0.1267|TWO_SIDED|95.0|-1.87|7.09||One-sided p-value was based on test of null hypothesis: (Daprodustat-Placebo) \<=0 versus alternative: difference \>0.|MMRM||Analysis was performed by MMRM with factors for treatment, time, region, Baseline value and Baseline value by time and treatment by time interactions for Difficulty Sleeping|||7.09|-1.87|0.1267
72591805|NCT03409107|144714713|SUPERIORITY||Mean Difference (Net)|4.64||||0.0203|TWO_SIDED|95.0|0.2|9.09||One-sided p-value was based on test of null hypothesis: (Daprodustat-Placebo) \<=0 versus alternative: difference \>0.|MMRM||Analysis was performed by MMRM with factors for treatment, time, region, Baseline value and Baseline value by time and treatment by time interactions for Difficulty Standing for Long Periods of Time|||9.09|0.20|0.0203
72591806|NCT03409107|144714713|SUPERIORITY||Mean Difference (Net)|2.68||||0.0266|TWO_SIDED|95.0|-0.04|5.39||One-sided p-value was based on test of null hypothesis: (Daprodustat-Placebo) \<=0 versus alternative: difference \>0.|MMRM||Analysis was performed by MMRM with factors for treatment, time, region, Baseline value and Baseline value by time and treatment by time interactions for Severity of Shortness of Breath While Sitting or Resting|||5.39|-0.04|0.0266
72591807|NCT03409107|144714713|SUPERIORITY||Mean Difference (Net)|2.01||||0.0907|TWO_SIDED|95.0|-0.94|4.96||One-sided p-value was based on test of null hypothesis: (Daprodustat-Placebo) \<=0 versus alternative: difference \>0.|MMRM||Analysis was performed by MMRM with factors for treatment, time, region, Baseline value and Baseline value by time and treatment by time interactions for Time with Shortness of Breath While not Doing an Activity|||4.96|-0.94|0.0907
72591808|NCT03409107|144714714|SUPERIORITY||Mean Difference (Net)|-0.13||||0.0391|TWO_SIDED|95.0|-0.28|0.02||One-sided p-value was based on test of null hypothesis: (Daprodustat-rhEPO) \>=0 versus alternative: difference \<0|MMRM||MMRM fitted from Baseline up to Week 28 with factors for treatment, time, region, Baseline value and Baseline value by time and treatment by time interactions.|||0.02|-0.28|0.0391
72591809|NCT03409107|144714715|SUPERIORITY||Mean Difference (Net)|2.57||||0.0858|TWO_SIDED|95.0|-1.12|6.26||One sided p-value was based on test of null hypothesis: (Daprodustat-Placebo) \<=0 vs. alternative: difference \>0.|MMRM||MMRM fitted from Baseline up to Week 28 with factors for treatment, time, region, Baseline value and Baseline value by time and treatment by time interactions.|||6.26|-1.12|0.0858
72591810|NCT03409107|144714716|SUPERIORITY||Mean Difference (Net)|0.17||||0.0357|TWO_SIDED|95.0|-0.02|0.36||One sided p-value based on test of null hypothesis: (Daprodustat-Placebo) \<=0 versus alternative: difference \>0.|MMRM||MMRM fitted from Baseline up to Week 28 with factors for treatment, time, region, Baseline value and Baseline value by time and treatment by time interactions for Did you feel full of life?.|||0.36|-0.02|0.0357
72591811|NCT03409107|144714716|SUPERIORITY||Mean Difference (Net)|0.17||||0.0328|TWO_SIDED|95.0|-0.01|0.35||One-sided p-value based on test of null hypothesis: (Daprodustat-Placebo) \<=0 versus alternative: difference \>0.|MMRM||MMRM fitted from Baseline up to Week 28 with factors for treatment, time, region, Baseline value and Baseline value by time and treatment by time interactions for Did you have a lot of energy?.|||0.35|-0.01|0.0328
72591812|NCT03409107|144714716|SUPERIORITY||Mean Difference (Net)|0.18||||0.0252|TWO_SIDED|95.0|0.0|0.37||One-sided p-value based on test of null hypothesis: (Daprodustat-Placebo) \<=0 versus alternative: difference \>0.|MMRM||MMRM fitted from Baseline up to Week 28 with factors for treatment, time, region, Baseline value and Baseline value by time and treatment by time interactions for Did you feel worn out?.|||0.37|0.00|0.0252
72591813|NCT03409107|144714716|SUPERIORITY||Mean Difference (Net)|0.26||||0.001|TWO_SIDED|95.0|0.1|0.42||One-sided p-value based on test of null hypothesis: (Daprodustat-Placebo) \<=0 versus alternative: difference \>0.|MMRM||MMRM fitted from Baseline up to Week 28 with factors for treatment, time, region, Baseline value and Baseline value by time and treatment by time interactions for Did you feel tired?.|||0.42|0.10|0.0010
72591814|NCT03409107|144714723|SUPERIORITY||Mean Difference (Net)|0.03||||0.1098|TWO_SIDED|95.0|-0.02|0.07||One-sided p-value was based on test of null hypothesis: (Daprodustat-Placebo) \<=0 versus. alternative: difference \>0.|MMRM||Based on MMRM model fitted from Baseline up to Week 28 with factors for treatment, time, region, Baseline value and Baseline value by time and treatment by time interactions.|||0.07|-0.02|0.1098
72591815|NCT03409107|144714724|SUPERIORITY||Mean Difference (Net)|4.5||||0.012|TWO_SIDED|95.0|0.6|8.4||One-sided p-value was based on test of null hypothesis: (Daprodustat-Placebo) \<=0 vs. alternative: difference \>0.|MMRM||MMRM model fitted from Baseline up to Week 28 with factors for treatment, time, region, Baseline value and Baseline value by time and treatment by time interactions.|||8.40|0.60|0.0120
72591816|NCT03409107|144714725|SUPERIORITY||Mean Difference (Net)|0.4||||0.6106|TWO_SIDED|95.0|-2.42|3.22||"One-sided p-value was based on test of null hypothesis: (Daprodustat - Placebo) \>= 0 versus alternative:~difference \<0"|MMRM||MMRM model fitted from Baseline up to Week 28, with factors for treatment, time, region, Baseline SBP and Baseline SBP by time and treatment by time interactions.|||3.22|-2.42|0.6106
72591817|NCT03409107|144714725|SUPERIORITY||Mean Difference (Net)|1.8||||0.9819|TWO_SIDED|95.0|0.12|3.49||"One-sided p-value was based on test of null hypothesis: (Daprodustat - Placebo) \>= 0 versus alternative:~difference \< 0"|MMRM||MMRM model fitted from Baseline up to Week 28, with factors for treatment, time, region, Baseline DBP and Baseline DBP by time and treatment by time interactions.|||3.49|0.12|0.9819
72591818|NCT03409107|144714725|SUPERIORITY||Mean Difference (Net)|1.31||||0.9215|TWO_SIDED|95.0|-0.51|3.13||"One-sided p-value was based on test of null hypothesis: (Daprodustat - Placebo) \>= 0 versus alternative:~difference \<0"|MMRM||MMRM model fitted from Baseline up to Week 28, with factors for treatment, time, region, Baseline MAP and Baseline MAP by time and treatment by time interactions.|||3.13|-0.51|0.9215
72591819|NCT03409107|144714726|SUPERIORITY||Difference in Response rate|0.06||||0.068|TWO_SIDED|95.0|-0.02|0.13||One-sided p-value based on test of null hypothesis: (Daprodustat - Placebo) \<= 0 versus alternative: difference \> 0.|Cochran-Mantel-Haenszel||Cochran-Mantel-Haenszel test was performed for treatment group comparison.|||0.13|-0.02|0.0680
72591820|NCT05010512|144714727|NON_INFERIORITY|Noninferiority in distance VA was declared if the least squares means difference upper confidence limit was less than 0.05.|Least Squares Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.004|||ONE_SIDED|95.0||0.01||Since a noninferiority hypothesis is being tested, a p-value is not applicable. Confidence limit is being reported and compared to the noninferiority margin.|||LSM results based on mixed effects repeated measures model with terms for lens, period and sequence as fixed effects, subject as a random effect. Difference = DT1 minus Infuse|||0.01||
72591821|NCT01152359|144714738|SUPERIORITY||Mean Difference (Final Values)|1.1|||<|0.05|TWO_SIDED|95.0|-0.8|2.9|||Mixed Models Analysis|||||2.9|-0.8|<0.05
72591822|NCT01152359|144714739|SUPERIORITY||Mean Difference (Final Values)|-0.9||||0.66|TWO_SIDED|95.0|-4.9|3.1|||Mixed Models Analysis|||||3.1|-4.9|0.66
72591823|NCT01152359|144714740|SUPERIORITY||Mean Difference (Net)|-0.8||||0.65|TWO_SIDED|95.0|-4.1|2.6|||Mixed Models Analysis|||||2.6|-4.1|0.65
72591824|NCT00535847|144714778|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|12.703|||||TWO_SIDED|95.0|4.259|37.884||||||Stratified Analysis (Mantel-Haenszel)- The Mantel-Haenszel estimator provides an estimate of the common odds ratio for the association between eRVR and SVR across the prior response strata.||37.884|4.259|
72591825|NCT01552915|144714792|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Mean|-2.1|STANDARD_ERROR_OF_MEAN|1.15||0.0717|TWO_SIDED|95.0|-4.3|0.2|||mixed effects model for repeated measure|||||0.2|-4.3|0.0717
72591826|NCT01552915|144714792|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Mean|-12.2|STANDARD_ERROR_OF_MEAN|1.45|<|0.0001|TWO_SIDED|95.0|-15.1|-9.4|||mixed effects model for repeated measure|||||-9.4|-15.1|<0.0001
72591827|NCT01552915|144714792|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Mean|-10.1|STANDARD_ERROR_OF_MEAN|1.43|<|0.0001|TWO_SIDED|95.0|-13.0|-7.3|||mixed effects model for repeated measure|||||-7.3|-13.0|<0.0001
72591828|NCT01552915|144714793|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6165|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.6165
72591829|NCT01552915|144714793|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.0001
72414488|NCT03147248|144338547|NON_INFERIORITY|The non-inferiority was to be concluded if the lower limit of the two-sided 95% confidence interval (CI) for the difference in the mean change from baseline of DAS28 (CRP) at Week 22 was greater that the pre-specified non-inferiority margin of -0.6.|Difference of Least square mean|0.27|||||TWO_SIDED|95.0|0.02|0.52|||||The least squares means and standard errors, estimate of treatment difference (CT-P13 SC 120 mg - CT-P13 IV 3 mg/kg), and 2-sided 95% CI obtained from the ANCOVA model.|Primary efficacy analysis were analyzed using an ANCOVA considering the treatment as fixed effect and country, serum CRP concentration at Week 2 (≤0.6 mg/dL vs. \>0.6 mg/dL), and body weight at Week 6 (≤100 kg vs. \>100 kg) as covariates.||0.52|0.02|
72414489|NCT02388724|144338556|NON_INFERIORITY|If the lower bound of the 95% confidence intervals of the difference was more than -10% (non-inferiority margin), non-inferiority for Vonoprazan relative to Lansoprazole was declared.|Difference in percentages|1.1|||||TWO_SIDED|95.0|-3.822|6.087||||||||6.087|-3.822|
72591830|NCT01552915|144714793|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.0001
72591831|NCT01258075|144714832|SUPERIORITY||LS mean difference|-0.13|STANDARD_ERROR_OF_MEAN|0.21||0.5494|TWO_SIDED|95.0|-0.54|0.29|||ANCOVA|Based on a mixed effect ANCOVA model with treatment and previous type 2 diabetes treatment stratum as fixed effects and baseline as a covariate.||||0.29|-0.54|0.5494
72414490|NCT02388724|144338557|SUPERIORITY||Difference in percentages|7.2|||||TWO_SIDED|95.0|-1.054|15.371||||||2 Weeks||15.371|-1.054|
72591832|NCT02783729|144714854|SUPERIORITY||Least Squares Geometric Mean(LSGM) Ratio|0.773|||=|0.0003|TWO_SIDED|95.0|0.672|0.889||Based on mixed effect model repeated measurement (MMRM) model with log transformation of LPS and factors for age group, region, treatment, visit (Days 29/30), and treatment-by-visit interaction as fixed effects, and the baseline LPS as a covariate.|MMRM|||||0.889|0.672|= 0.0003
72414491|NCT02388724|144338557|SUPERIORITY||Difference in percentages|1.8|||||TWO_SIDED|95.0|-4.763|8.395||||||4 Weeks||8.395|-4.763|
72414492|NCT02605954|144338568|NON_INFERIORITY|With 200 participants randomized to switch to the E/C/F/TAF FDC group at Day 1 and 100 participants randomized to the ABC/3TC+3rd Agent group at Week 24, the lower limit of the observed one sided 97.5% confidence interval was expected to be greater than -0.120 (ie, non-inferiority margin of 12%) with \> 90% power when the percentage of responders in both treatment groups for the primary endpoint is at least 90% at Week 24.|Difference in Percentages|-4.4||||0.15|TWO_SIDED|95.0|-9.4|1.9|||Fisher Exact|||||1.9|-9.4|0.15
72414493|NCT02605954|144338569|NON_INFERIORITY|With 200 participants randomized to switch to the E/C/F/TAF FDC group at Day 1 and 100 participants randomized to the delayed switch group at Week 12, the lower limit of the observed one sided 97.5% confidence interval will be expected to be greater than -0.120 (ie, non-inferiority margin of 12%) with \> 90% power when the percentage of responders in both treatment groups for the primary endpoint is at least 90% at Week 12.|Difference in Percentages|-3.8||||0.17|TWO_SIDED|95.0|-8.3|1.6|||Fisher Exact|||||1.6|-8.3|0.17
72414494|NCT02605954|144338571|OTHER||Difference in least square mean|-36.0||||0.11|TWO_SIDED|95.0|-80.0|9.0|||ANOVA|||||9|-80|0.11
72591833|NCT02783729|144714854|SUPERIORITY||LSGM Ratio|0.723|||<|0.0001|TWO_SIDED|95.0|0.628|0.832||Based on MMRM model with log transformation of LPS and factors for age group, region, treatment, visit (Days 29/30), and treatment-by-visit interaction as fixed effects, and the baseline LPS as a covariate.|MMRM|||||0.832|0.628|< 0.0001
72591834|NCT02783729|144714855|SUPERIORITY||Least Squares Mean (LSM) Difference|7.07|STANDARD_ERROR_OF_MEAN|0.746|<|0.0001|TWO_SIDED|95.0|5.61|8.54||Based on MMRM model with factors of age group, region, treatment, visit (Days 29/30), and treatment-by-visit interaction as fixed effect, and the baseline SE as a covariate.|MMRM|||||8.54|5.61|< 0.0001
72591835|NCT02783729|144714855|SUPERIORITY||LSM Difference|8.03|STANDARD_ERROR_OF_MEAN|0.746|<|0.0001|TWO_SIDED|95.0|6.57|9.49||Based on MMRM model with factors of age group, region, treatment, visit (Days 29/30), and treatment-by-visit interaction as fixed effect, and the baseline SE as a covariate.|MMRM|||||9.49|6.57|< 0.0001
72591836|NCT02783729|144714856|SUPERIORITY||LSM Difference|-23.96|STANDARD_ERROR_OF_MEAN|3.068|<|0.0001|TWO_SIDED|95.0|-29.98|-17.95||Based on MMRM model with factors of age group, region, treatment, visit (Days 29/30), and treatment-by-visit interaction as fixed effect, and the baseline WASO as a covariate.|MMRM|||||-17.95|-29.98|< 0.0001
72414495|NCT03814889|144338776|OTHER|||||||0.00025|||||||Wilcoxon Signed-Rank|Paired, ordinal data||||||0.00025
72414496|NCT03814889|144338777|OTHER|||||||0.0014|||||||Wilcoxon Signed-Rank|||||||0.0014
72414497|NCT03814889|144338778|OTHER|||||||0.02|||||||t-test, 1 sided|||||||0.02
72414498|NCT03814889|144338779|OTHER|||||||0.001|||||||t-test, 1 sided|||||||0.001
72414499|NCT03814889|144338782|OTHER|||||||0.001|||||||Wilcoxcon Signed-Ranks|||||||0.001
72414500|NCT02103439|144338800|NON_INFERIORITY_OR_EQUIVALENCE|the lower limit of the 95% confidence interval for the difference in proportions between the difference in the early virological response rate with Algeron and PegIntron should be higher than the non-inferiority margin of 0.2 (-20%)||||||0.227|TWO_SIDED||||||Fisher Exact|||||||0.227
72414501|NCT02103439|144338801|NON_INFERIORITY_OR_EQUIVALENCE|the lower limit of the 95 % confidence interval between the difference in rate of rapid virological response with Algeron and PegIntron should be more than the non-inferiority margin (-20 %)|||||>|0.05|TWO_SIDED||||||Fisher Exact|||||||> 0.05
72591837|NCT02783729|144714856|SUPERIORITY||LSM Difference|-25.35|STANDARD_ERROR_OF_MEAN|3.067|<|0.0001|TWO_SIDED|95.0|-31.36|-19.34|||MMRM|||||-19.34|-31.36|< 0.0001
72591838|NCT02783729|144714857|SUPERIORITY|Based on MMRM model with factors of age group, region, treatment, visit (Days 29/30), and treatment-by-visit interaction as fixed effect, and the baseline WASO2H as a covariate.|LSM Difference|-6.65|STANDARD_ERROR_OF_MEAN|2.298|=|0.0038|TWO_SIDED|95.0|-11.15|-2.15|||MMRM|||||-2.15|-11.15|= 0.0038
72591839|NCT02783729|144714857|SUPERIORITY|Based on MMRM model with factors of age group, region, treatment, visit (Days 29/30), and treatment-by-visit interaction as fixed effect, and the baseline WASO2H as a covariate.|LSM Difference|-8.0|STANDARD_ERROR_OF_MEAN|2.309|=|0.0005|TWO_SIDED|95.0|-12.53|-3.47|||MMRM|||||-3.47|-12.53|= 0.0005
72591840|NCT02783729|144714858|SUPERIORITY||LSM Difference|-9.63|STANDARD_ERROR_OF_MEAN|4.029|=|0.0171|TWO_SIDED|95.0|-17.53|-1.72||Based on MMRM model with factors of age group, region, treatment, visit (Days 2/3), and treatment-by-visit interaction as fixed effect, and the baseline posture stability of body sway as a covariate.|MMRM|||Zolpidem Tartrate Extended Release 6.25 mg v Lemborexant 5 mg||-1.72|-17.53|= 0.0171
72591841|NCT02783729|144714858|SUPERIORITY||LSM Difference|-10.74|STANDARD_ERROR_OF_MEAN|4.04|=|0.008|TWO_SIDED|95.0|-18.67|-2.81||Based on MMRM model with factors of age group, region, treatment, visit (Days 2/3), and treatment-by-visit interaction as fixed effect, and the baseline posture stability of body sway as a covariate.|MMRM|||Zolpidem Tartrate Extended Release 6.25 mg v Lemborexant 10 mg||-2.81|-18.67|= 0.008
72591842|NCT02783729|144714859|SUPERIORITY||LSGM Ratio|0.874|||=|0.0218|TWO_SIDED|95.0|0.78|0.981||Based on MMRM model with log transformation of LPS and factors for age group, region, treatment, visit (Days 1/2), and treatment-by-visit interaction as fixed effects, and the baseline LPS as a covariate.|MMRM|||LPS, Days 1/2: Zolpidem ER, Lemborexant 5 mg||0.981|0.78|= 0.0218
72414502|NCT00321854|144338862|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.4|STANDARD_ERROR_OF_MEAN|0.9||0.6503||95.0|-2.2|1.4|||ANCOVA|||||1.4|-2.2|0.6503
72591843|NCT02783729|144714859|OTHER||LSGM Ratio|0.818|||=|0.0006|TWO_SIDED|95.0|0.729|0.917||Based on MMRM model with log transformation of LPS and factors for age group, region, treatment, visit (Days 1/2), and treatment-by-visit interaction as fixed effects, and the baseline LPS as a covariate.|MMRM|||LPS, Days 1/2: Zolpidem ER, Lemborexant 10 mg||0.917|0.729|= 0.0006
72591844|NCT02783729|144714859|SUPERIORITY||LSGM Ratio|0.634|||<|0.0001|TWO_SIDED|95.0|0.556|0.724||Based on MMRM model with log transformation of LPS and factors for age group, region, treatment, visit (Days 29/30), and treatment-by-visit interaction as fixed effects, and the baseline LPS as a covariate.|MMRM|||LPS, Days 29/30: Zolpidem ER, Lemborexant 5 mg||0.724|0.556|< 0.0001
72591845|NCT02783729|144714859|SUPERIORITY||LSGM Ratio|0.594|||<|0.0001|TWO_SIDED|95.0|0.521|0.677||Based on MMRM model with log transformation of LPS and factors for age group, region, treatment, visit (Days 29/30), and treatment-by-visit interaction as fixed effects, and the baseline LPS as a covariate.|MMRM|||LPS, Days 29/30: Zolpidem ER, Lemborexant 10 mg||0.677|0.521|< 0.0001
72591846|NCT02783729|144714859|SUPERIORITY||LSM Difference|-6.16|STANDARD_ERROR_OF_MEAN|2.544|=|0.0154|TWO_SIDED|95.0|-11.15|-1.17||Based on MMRM model with factors for age group, region, treatment, visit (Days 1/2), and treatment-by-visit interaction as fixed effects, and the baseline WASO as a covariate.|MMRM|||WASO, Days 1/2: Zolpidem ER, Lemborexant 5 mg||-1.17|-11.15|= 0.0154
72591847|NCT02783729|144714859|SUPERIORITY||LSM Difference|-15.03|STANDARD_ERROR_OF_MEAN|2.542|<|0.0001|TWO_SIDED|95.0|-20.01|-10.05||Based on MMRM model with factors for age group, region, treatment, visit (Days 1/2), and treatment-by-visit interaction as fixed effects, and the baseline WASO as a covariate.|MMRM|||WASO, Days 1/2: Zolpidem ER, Lemborexant 10 mg||-10.05|-20.01|< 0.0001
72414503|NCT00321854|144338863|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|0.9||0.9568||95.0|-1.7|1.8|||ANCOVA|||||1.8|-1.7|0.9568
72591848|NCT02783729|144714859|SUPERIORITY||LSM Difference|-7.72|STANDARD_ERROR_OF_MEAN|2.876|=|0.0073|TWO_SIDED|95.0|-13.36|-2.08||Based on MMRM model with factors for age group, region, treatment, visit (Days 29/30), and treatment-by-visit interaction as fixed effects, and the baseline WASO as a covariate.|MMRM|||WASO, Days 29/30: Zolpidem ER, Lemborexant 5 mg||-2.08|-13.36|= 0.0073
72591849|NCT02783729|144714859|SUPERIORITY||LSM Difference|-9.1|STANDARD_ERROR_OF_MEAN|2.883|=|0.0016|TWO_SIDED|95.0|-14.75|-3.45|||MMRM|||WASO, Days 29/30: Zolpidem ER, Lemborexant 10 mg||-3.45|-14.75|= 0.0016
72591850|NCT02783729|144714859|SUPERIORITY||LSM Difference|10.25|STANDARD_ERROR_OF_MEAN|3.094|=|0.001|TWO_SIDED|95.0|4.18|16.32||Based on MMRM model with factors for age group, region, treatment, visit (Days 1/2), and treatment-by-visit interaction as fixed effects, and the baseline TST as a covariate.|MMRM|||TST, Days 1/2: Zolpidem ER, Lemborexant 5 mg||16.32|4.18|= 0.001
72591851|NCT02783729|144714859|SUPERIORITY||LSM Difference|23.1|STANDARD_ERROR_OF_MEAN|3.085|<|0.0001|TWO_SIDED|95.0|17.04|29.15||Based on MMRM model with factors for age group, region, treatment, visit (Days 1/2), and treatment-by-visit interaction as fixed effects, and the baseline TST as a covariate.|MMRM|||TST, Days 1/2: Zolpidem ER, Lemborexant 10 mg||29.15|17.04|< 0.0001
72591852|NCT02783729|144714859|SUPERIORITY||LSM Difference|19.41|STANDARD_ERROR_OF_MEAN|3.457|<|0.0001|TWO_SIDED|95.0|12.63|26.2||Based on MMRM model with factors for age group, region, treatment, visit (Days 29/30), and treatment-by-visit interaction as fixed effects, and the baseline TST as a covariate.|MMRM|||TST, Days 29/30: Zolpidem ER, Lemborexant 5 mg||26.2|12.63|< 0.0001
72591853|NCT02783729|144714859|SUPERIORITY||LSM Difference|24.1|STANDARD_ERROR_OF_MEAN|3.456|<|0.0001|TWO_SIDED|95.0|17.32|30.88||Based on MMRM model with factors for age group, region, treatment, visit (Days 29/30), and treatment-by-visit interaction as fixed effects, and the baseline TST as a covariate.|MMRM|||TST, Days 29/30: Zolpidem ER, Lemborexant 10 mg||30.88|17.32|< 0.0001
72414504|NCT00321854|144338864|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.8|STANDARD_ERROR_OF_MEAN|0.8|<|0.0001||95.0|-6.3|-3.2|||ANCOVA|||||-3.2|-6.3|<0.0001
72414505|NCT00321854|144338865|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.4|STANDARD_ERROR_OF_MEAN|0.7|<|0.0001||95.0|-5.8|-3.0|||ANCOVA|||||-3|-5.8|<0.0001
72414506|NCT00321854|144338866|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.9|STANDARD_ERROR_OF_MEAN|0.6|<|0.0001||95.0|-4.1|-1.7|||ANCOVA|||||-1.7|-4.1|<0.0001
72591854|NCT02783729|144714860|SUPERIORITY||LSGM Ratio|0.898|||=|0.0122|TWO_SIDED|95.0|0.825|0.977||Based on MMRM model model with log transformation of sSOL and factors of age group, region, treatment, visit (First 7 Nights), and treatment-by-visit interaction as fixed effects, and the baseline sSOL as a covariate.|MMRM|||sSOL, First 7 nights: Zolpidem ER, Lemborexant 5 mg||0.977|0.825|= 0.0122
72591855|NCT02783729|144714860|SUPERIORITY||LSGM Ratio|0.83|||<|0.0001|TWO_SIDED|95.0|0.763|0.902||Based on MMRM model model with log transformation of sSOL and factors of age group, region, treatment, visit (First 7 Nights), and treatment-by-visit interaction as fixed effects, and the baseline sSOL as a covariate.|MMRM|||sSOL, First 7 nights: Zolpidem ER, Lemborexant 10 mg||0.902|0.763|< 0.0001
72591856|NCT02783729|144714860|SUPERIORITY||LSGM Ratio|0.882|||=|0.0176|TWO_SIDED|95.0|0.796|0.978||Based on MMRM model model with log transformation of sSOL and factors of age group, region, treatment, visit (Last 7 Nights), and treatment-by-visit interaction as fixed effects, and the baseline sSOL as a covariate.|MMRM|||sSOL, Last 7 nights: Zolpidem ER, Lemborexant 5 mg||0.978|0.796|= 0.0176
72591857|NCT02783729|144714860|SUPERIORITY||LSGM Ratio|0.811|||<|0.0001|TWO_SIDED|95.0|0.732|0.899||Based on MMRM model model with log transformation of sSOL and with factors of age group, region, treatment, visit (Last 7 Nights), and treatment-by-visit interaction as fixed effects, and the baseline sSOL as a covariate.|MMRM|||sSOL, Last 7 nights: Zolpidem ER, Lemborexant 10 mg||0.899|0.732|< 0.0001
72591858|NCT02783729|144714860|SUPERIORITY||LSM Difference|8.12|STANDARD_ERROR_OF_MEAN|4.484|=|0.0706|TWO_SIDED|95.0|-0.68|16.91||Based on MMRM model with factors of age group, region, treatment, visit (First 7 Nights), and treatment-by-visit interaction as fixed effects, and the baseline sWASO as a covariate.|MMRM|||sWASO, First 7 nights: Zolpidem ER, Lemborexant 5 mg||16.91|-0.68|= 0.0706
72591859|NCT02783729|144714860|SUPERIORITY||LSM Difference|-5.81|STANDARD_ERROR_OF_MEAN|4.481|=|0.1949|TWO_SIDED|95.0|-14.61|2.98||Based on MMRM model with factors of age group, region, treatment, visit (First 7 Nights), and treatment-by-visit interaction as fixed effects, and the baseline sWASO as a covariate.|MMRM|||sWASO, First 7 nights: Zolpidem ER, Lemborexant 10 mg||2.98|-14.61|= 0.1949
72591860|NCT02783729|144714860|SUPERIORITY||LSM Difference|14.45|STANDARD_ERROR_OF_MEAN|5.241|=|0.0059|TWO_SIDED|95.0|4.16|24.73||Based on MMRM model with factors of age group, region, treatment, visit (Last 7 Nights), and treatment-by-visit interaction as fixed effects, and the baseline sWASO as a covariate.|MMRM|||sWASO, Last 7 nights: Zolpidem ER, Lemborexant 5 mg||24.73|4.16|= 0.0059
72591861|NCT02783729|144714860|SUPERIORITY||LSM Difference|5.36|STANDARD_ERROR_OF_MEAN|5.241|=|0.3064|TWO_SIDED|95.0|-4.92|15.65||Based on MMRM model with factors of age group, region, treatment, visit (Last 7 Nights), and treatment-by-visit interaction as fixed effects, and the baseline sWASO as a covariate.|MMRM|||sWASO, Last 7 nights: Zolpidem ER, Lemborexant 10 mg||15.65|-4.92|= 0.3064
72591862|NCT02783729|144714860|SUPERIORITY||LSM Difference|-6.57|STANDARD_ERROR_OF_MEAN|5.325|=|0.2174|TWO_SIDED|95.0|-17.02|3.88||Based on MMRM model with factors of age group, region, treatment, visit (First 7 Nights), and treatment-by-visit interaction as fixed effects, and the baselines sTST as a covariate.|MMRM|||sTST, First 7 nights: Zolpidem ER, Lemborexant 5 mg||3.88|-17.02|= 0.2174
72591863|NCT02783729|144714860|SUPERIORITY||LSM Difference|8.88|STANDARD_ERROR_OF_MEAN|5.313|=|0.0949|TWO_SIDED|95.0|-1.55|19.31||Based on MMRM model with factors of age group, region, treatment, visit (First 7 Nights), and treatment-by-visit interaction as fixed effects, and the baseline sTST as a covariate.|MMRM|||sTST, First 7 nights: Zolpidem ER, Lemborexant 10 mg||19.31|-1.55|= 0.0949
72414507|NCT00321854|144338867|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1|STANDARD_ERROR_OF_MEAN|0.9||0.8693||95.0|-1.8|1.5|||ANCOVA|||||1.5|-1.8|0.8693
72414508|NCT00321854|144338868|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.2|STANDARD_ERROR_OF_MEAN|0.9||0.8155||95.0|-1.5|1.9|||ANCOVA|||||1.9|-1.5|0.8155
72414509|NCT00321854|144338869|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.5|STANDARD_ERROR_OF_MEAN|0.8|<|0.0001||95.0|-6.0|-3.0|||ANCOVA|||||-3|-6|<0.0001
72414510|NCT00321854|144338870|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.0|STANDARD_ERROR_OF_MEAN|0.7|<|0.0001||95.0|-5.4|-2.6|||ANCOVA|||||-2.6|-5.4|<0.0001
72414511|NCT00321854|144338871|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.8|STANDARD_ERROR_OF_MEAN|0.6|<|0.0001||95.0|-3.9|-1.7|||ANCOVA|||||-1.7|-3.9|<0.0001
72414512|NCT00321854|144338872|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.2|STANDARD_ERROR_OF_MEAN|0.7||0.7999||95.0|-1.5|1.1|||ANCOVA|||||1.1|-1.5|0.7999
72591864|NCT02783729|144714860|SUPERIORITY||LSM Difference|-6.82|STANDARD_ERROR_OF_MEAN|6.207|=|0.2718|TWO_SIDED|95.0|-19.01|5.36||Based on MMRM model with factors of age group, region, treatment, visit (Last 7 Nights), and treatment-by-visit interaction as fixed effects, and the baseline sTST as a covariate.|MMRM|||sTST, Last 7 nights: Zolpidem ER, Lemborexant 5 mg||5.36|-19.01|= 0.2718
72591865|NCT02783729|144714860|SUPERIORITY||LSM Difference|7.43|STANDARD_ERROR_OF_MEAN|6.206|=|0.2317|TWO_SIDED|95.0|-4.75|19.61||Based on MMRM model with factors of age group, region, treatment, visit (Last 7 Nights), and treatment-by-visit interaction as fixed effects, and the baseline sTST as a covariate.|MMRM|||sTST, Last 7 nights: Zolpidem ER, Lemborexant 10 mg||19.61|-4.75|= 0.2317
72414513|NCT00321854|144338873|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.2|STANDARD_ERROR_OF_MEAN|0.7||0.7395||95.0|-1.1|1.5|||ANCOVA|||||1.5|-1.1|0.7395
72414514|NCT00321854|144338874|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.3|STANDARD_ERROR_OF_MEAN|0.6|<|0.0001||95.0|-4.5|-2.2|||ANCOVA|||||-2.2|-4.5|<0.0001
72414515|NCT00321854|144338875|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.9|STANDARD_ERROR_OF_MEAN|0.6|<|0.0001||95.0|-4.0|-1.8|||ANCOVA|||||-1.8|-4|<0.0001
72591866|NCT02783729|144714861|SUPERIORITY||LSM Difference|-1.37|STANDARD_ERROR_OF_MEAN|1.063|=|0.1963|TWO_SIDED|95.0|-3.46|0.71||Based on MMRM model with factors of age group, region, treatment, visit (First 7 Nights), and treatment-by-visit interaction as fixed effects, and the baseline sSE as a covariate.|MMRM|||sSE, First 7 nights: Zolpidem ER, Lemborexant 5 mg||0.71|-3.46|= 0.1963
72591867|NCT02783729|144714861|SUPERIORITY|Based on MMRM model with factors of age group, region, treatment, visit (First 7 Nights), and treatment-by-visit interaction as fixed effects, and the baseline sSE as a covariate|LSM Difference|1.7|STANDARD_ERROR_OF_MEAN|1.06|=|0.1093|TWO_SIDED|95.0|-0.38|3.78|||MMRM|||sSE, First 7 nights: Zolpidem ER, Lemborexant 10 mg||3.78|-0.38|= 0.1093
72591868|NCT02783729|144714861|SUPERIORITY||LSM Difference|-1.53|STANDARD_ERROR_OF_MEAN|1.247|=|0.2196|TWO_SIDED|95.0|-3.98|0.92||Based on MMRM model with factors of age group, region, treatment, visit (Last 7 Nights), and treatment-by-visit interaction as fixed effects, and the baseline sSE as a covariate.|MMRM|||sSE, Last 7 nights: Zolpidem ER, Lemborexant 5 mg||0.92|-3.98|= 0.2196
72414516|NCT00321854|144338876|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.8|STANDARD_ERROR_OF_MEAN|0.5||0.0002||95.0|-2.7|-0.9|||ANCOVA|||||-0.9|-2.7|0.0002
72414517|NCT00321854|144338877|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|0.3||0.9256||95.0|-0.6|0.6|||ANCOVA|||||0.6|-0.6|0.9256
72591869|NCT02783729|144714861|SUPERIORITY||LSM Difference|1.05|STANDARD_ERROR_OF_MEAN|1.246|=|0.4013|TWO_SIDED|95.0|-1.4|3.49||Based on MMRM model with factors of age group, region, treatment, visit (Last 7 Nights), and treatment-by-visit interaction as fixed effects, and the baseline sSE as a covariate.|MMRM|||sSE, Last 7 nights: Zolpidem ER, Lemborexant 10 mg||3.49|-1.4|= 0.4013
72591870|NCT02783729|144714862|SUPERIORITY||LSGM Ratio|0.85|||=|0.0092|TWO_SIDED|95.0|0.752|0.961||Based on MMRM model with factors of age group, region, treatment, visit (Days 1/2), and treatment-by-visit interaction as fixed effects, and the baseline LPS as a covariate.|MMRM|||LPS: Placebo, Lemborexant 5 mg||0.961|0.752|= 0.0092
72591871|NCT02783729|144714862|SUPERIORITY||LSGM Ratio|0.795|||=|0.0002|TWO_SIDED|95.0|0.704|0.899||Based on MMRM model with factors of age group, region, treatment, visit (Days1/2), and treatment-by-visit interaction as fixed effects, and the baseline LPS as a covariate.|MMRM|||LPS: Placebo, Lemborexant 10 mg||0.899|0.704|= 0.0002
72591872|NCT02783729|144714862|SUPERIORITY||LSM Difference|-33.4|STANDARD_ERROR_OF_MEAN|2.711|<|0.0001|TWO_SIDED|95.0|-38.71|-28.09||Based on MMRM model with factors of age group, region, treatment, visit (Days 1/2), and treatment-by-visit interaction as fixed effect, and the baseline WASO as a covariate.|MMRM|||WASO: Placebo, Lemborexant 5 mg||-28.09|-38.71|< 0.0001
72591873|NCT02783729|144714862|SUPERIORITY||LSM Difference|-42.27|STANDARD_ERROR_OF_MEAN|2.705|<|0.0001|TWO_SIDED|95.0|-47.57|-36.97||Based on MMRM model with factors of age group, region, treatment, visit (Days 1/2), and treatment-by-visit interaction as fixed effect, and the baseline WASO as a covariate.|MMRM|||WASO: Placebo, Lemborexant 10 mg||-36.97|-47.57|< 0.0001
72591874|NCT02783729|144714862|SUPERIORITY||LSM Difference|-21.66|STANDARD_ERROR_OF_MEAN|2.221|<|0.0001|TWO_SIDED|95.0|-26.01|-17.3||Based on MMRM model with factors of age group, region, treatment, visit (Days 1/2), and treatment-by-visit interaction as fixed effects, and the baseline WASO2H as a covariate.|MMRM|||WASO2H: Placebo, Lemborexant 5 mg||-17.3|-26.01|< 0.0001
72591875|NCT02783729|144714862|SUPERIORITY||LSM Difference|-28.33|STANDARD_ERROR_OF_MEAN|2.219|<|0.0001|TWO_SIDED|95.0|-32.68|-23.98||Based on MMRM model with factors of age group, region, treatment, visit (Days 1/2), and treatment-by-visit interaction as fixed effects, and the baseline WASO2H as a covariate.|MMRM|||WASO2H: Placebo, Lemborexant 10 mg||-23.98|-32.68|< 0.0001
72591876|NCT02783729|144714862|SUPERIORITY||LSM Difference|44.05|STANDARD_ERROR_OF_MEAN|3.291|<|0.0001|TWO_SIDED|95.0|37.59|50.51||Based on MMRM model with factors of age group, region, treatment, visit (Days 1/2), and treatment-by-visit interaction as fixed effect, and the baseline TST as a covariate.|MMRM|||TST: Placebo, Lemborexant 5 mg||50.51|37.59|< 0.0001
72591877|NCT02783729|144714862|SUPERIORITY||LSM Difference|56.9|STANDARD_ERROR_OF_MEAN|3.284|<|0.0001|TWO_SIDED|95.0|50.46|63.34||Based on MMRM model with factors of age group, region, treatment, visit (Days 1/2), and treatment-by-visit interaction as fixed effect, and the baseline TST as a covariate.|MMRM|||TST: Placebo, Lemborexant 10 mg||63.34|50.46|< 0.0001
72591878|NCT02783729|144714863|SUPERIORITY||LSM Difference|9.01|STANDARD_ERROR_OF_MEAN|0.666|<|0.0001|TWO_SIDED|95.0|7.7|10.31||Based on MMRM model with factors of age group, region, treatment, visit (Days 1/2), and treatment-by-visit interaction as fixed effects, and the baseline SE as a covariate.|MMRM|||SE: Placebo, Lemborexant 5 mg||10.31|7.7|< 0.0001
72591879|NCT02783729|144714863|SUPERIORITY||LSM Difference|11.6|STANDARD_ERROR_OF_MEAN|0.664|<|0.0001|TWO_SIDED|95.0|10.3|12.9||Based on MMRM model with factors of age group, region, treatment, visit (Days 1/2), and treatment-by-visit interaction as fixed effect, and the baseline SE as a covariate.|MMRM|||SE: Placebo, Lemborexant 10 mg||12.9|10.3|< 0.0001
72591880|NCT02783729|144714864|SUPERIORITY||LSM Difference|-16.41|STANDARD_ERROR_OF_MEAN|2.457|<|0.0001|TWO_SIDED|95.0|-21.23|-11.6||Based on MMRM model with factors of age group, region, treatment, visit (Days 29/30), and treatment-by-visit interaction as fixed effect, and the baseline WASO2H as a covariate.|MMRM|||WASO2H: Placebo, Lemborexant 5 mg||-11.6|-21.23|< 0.0001
72591881|NCT02783729|144714864|SUPERIORITY||LSM Difference|-17.76|STANDARD_ERROR_OF_MEAN|2.451|<|0.0001|TWO_SIDED|95.0|-22.57|-12.96||Based on MMRM model with factors of age group, region, treatment, visit (Days 29/30), and treatment-by-visit interaction as fixed effect, and the baseline WASO2H as a covariate.|MMRM|||WASO2H: Placebo, Lemborexant 10 mg||-12.96|-22.57|< 0.0001
72591882|NCT02783729|144714864|SUPERIORITY||LSM Difference|34.16|STANDARD_ERROR_OF_MEAN|3.673|<|0.0001|TWO_SIDED|95.0|26.95|41.36||Based on MMRM model with factors of age group, region, treatment, visit (Days 29/30), and treatment-by-visit interaction as fixed effect, and the baseline TST as a covariate.|MMRM|||TST: Placebo, Lemborexant 5 mg||41.36|26.95|< 0.0001
72591883|NCT02783729|144714864|SUPERIORITY||LSM Difference|38.85|STANDARD_ERROR_OF_MEAN|3.672|<|0.0001|TWO_SIDED|95.0|31.64|46.05||Based on MMRM model with factors of age group, region, treatment, visit (Days 29/30), and treatment-by-visit interaction as fixed effect, and the baseline TST as a covariate.|MMRM|||TST: Placebo, Lemborexant 10 mg||46.05|31.64|< 0.0001
72414518|NCT00321854|144338878|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|0.3||0.9792||95.0|-0.6|0.6|||ANCOVA|||||0.6|-0.6|0.9792
72414519|NCT00321854|144338879|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.1|STANDARD_ERROR_OF_MEAN|0.3||0.0001||95.0|-1.7|-0.5|||ANCOVA|||||-0.5|-1.7|0.0001
72591884|NCT02783729|144714865|SUPERIORITY||LSGM Ratio|0.815|||<|0.0001|TWO_SIDED|95.0|0.745|0.891||Based on MMRM model with factors of age group, region, treatment, visit (First 7 Nights), and treatment-by-visit interaction as fixed effects, and the baseline sSOL as a covariate.|MMRM|||sSOL, First 7 nights: Placebo, Lemborexant 5 mg||0.891|0.745|< 0.0001
72591885|NCT02783729|144714865|SUPERIORITY||LSGM Ratio|0.753|||<|0.0001|TWO_SIDED|95.0|0.689|0.823||Based on MMRM model with factors of age group, region, treatment, visit (First 7 Nights), and treatment-by-visit interaction as fixed effects, and the baseline sSOL as a covariate.|MMRM|||sSOL, First 7 nights: Placebo, Lemborexant 10 mg||0.823|0.689|< 0.0001
72591886|NCT02783729|144714865|SUPERIORITY||LSGM Ratio|0.75|||<|0.0001|TWO_SIDED|95.0|0.671|0.837||Based on MMRM model with factors of age group, region, treatment, visit (Last 7 Nights), and treatment-by-visit interaction as fixed effects, and the baseline sSOL as a covariate.|MMRM|||sSOL, Last 7 nights: Placebo, Lemborexant 5 mg||0.837|0.671|< 0.0001
72591887|NCT02783729|144714865|SUPERIORITY||LSGM Ratio|0.689|||<|0.0001|TWO_SIDED|95.0|0.618|0.769||Based on MMRM model with factors of age group, region, treatment, visit (Last 7 Nights), and treatment-by-visit interaction as fixed effects, and the baseline sSOL as a covariate.|MMRM|||sSOL, Last 7 nights: Placebo, Lemborexant 10 mg||0.769|0.618|< 0.0001
72591888|NCT02783729|144714865|SUPERIORITY||LSM Difference|-12.41|STANDARD_ERROR_OF_MEAN|4.764|=|0.0093|TWO_SIDED|95.0|-21.76|-3.06||Based on MMRM model with factors of age group, region, treatment, visit (First 7 Nights), and treatment-by-visit interaction as fixed effects, and the baseline sWASO as a covariate.|MMRM|||sWASO, First 7 nights: Placebo, Lemborexant 5 mg||-3.06|-21.76|= 0.0093
72591889|NCT02783729|144714865|SUPERIORITY||LSM Difference|-26.34|STANDARD_ERROR_OF_MEAN|4.762|<|0.0001|TWO_SIDED|95.0|-35.68|-16.99||Based on MMRM model with factors of age group, region, treatment, visit (First 7 Nights), and treatment-by-visit interaction as fixed effects, and the baseline sWASO as a covariate.|MMRM|||sWASO, First 7 nights: Placebo, Lemborexant 10 mg||-16.99|-35.68|< 0.0001
72591890|NCT02783729|144714865|SUPERIORITY||LSM Difference|-11.49|STANDARD_ERROR_OF_MEAN|5.573|=|0.0396|TWO_SIDED|95.0|-22.42|-0.55||Based on MMRM model with factors of age group, region, treatment, visit (Last 7 Nights), and treatment-by-visit interaction as fixed effects, and the baseline sWASO as a covariate.|MMRM|||sWASO, Last 7 nights: Placebo, Lemborexant 5 mg||-0.55|-22.42|= 0.0396
72591891|NCT02783729|144714865|SUPERIORITY||LSM Difference|-20.57|STANDARD_ERROR_OF_MEAN|5.574|=|0.0002|TWO_SIDED|95.0|-31.51|-9.63||Based on MMRM model with factors of age group, region, treatment, visit (Last 7 Nights), and treatment-by-visit interaction as fixed effects, and the baseline sWASO as a covariate.|MMRM|||sWASO, Last 7 nights: Placebo, Lemborexant 10 mg||-9.63|-31.51|= 0.0002
72591892|NCT02783729|144714865|SUPERIORITY||LSM Difference|19.05|STANDARD_ERROR_OF_MEAN|5.619|=|0.0007|TWO_SIDED|95.0|8.03|30.08||Based on MMRM model with factors of age group, region, treatment, visit (First 7 Nights), and treatment-by-visit interaction as fixed effects, and the baselines sTST as a covariate.|MMRM|||sTST, First 7 nights: Placebo, Lemborexant 5 mg||30.08|8.03|= 0.0007
72591893|NCT02783729|144714865|SUPERIORITY||LSM Difference|34.51|STANDARD_ERROR_OF_MEAN|5.609|<|0.0001|TWO_SIDED|95.0|23.5|45.52||Based on MMRM model with factors of age group, region, treatment, visit (First 7 Nights), and treatment-by-visit interaction as fixed effects, and the baselines sTST as a covariate.|MMRM|||sTST, First 7 nights: Placebo, Lemborexant 10 mg||45.52|23.5|< 0.0001
72591894|NCT02783729|144714865|SUPERIORITY||LSM Difference|23.57|STANDARD_ERROR_OF_MEAN|6.565|=|0.0003|TWO_SIDED|95.0|10.68|36.45||Based on MMRM model with factors of age group, region, treatment, visit (Last 7 Nights), and treatment-by-visit interaction as fixed effects, and the baseline sTST as a covariate.|MMRM|||sTST, Last 7 nights: Placebo, Lemborexant 5 mg||36.45|10.68|= 0.0003
72414520|NCT00321854|144338880|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.1|STANDARD_ERROR_OF_MEAN|0.3|<|0.0001||95.0|-1.6|-0.6|||ANCOVA|||||-0.6|-1.6|<0.0001
72591895|NCT02783729|144714865|SUPERIORITY||LSM Difference|37.82|STANDARD_ERROR_OF_MEAN|6.565|<|0.0001|TWO_SIDED|95.0|24.94|50.71||Based on MMRM model with factors of age group, region, treatment, visit (Last 7 Nights), and treatment-by-visit interaction as fixed effects, and the baseline sTST as a covariate.|MMRM|||sTST, Last 7 nights: Placebo, Lemborexant 10 mg||50.71|24.94|< 0.0001
72591896|NCT02783729|144714866|SUPERIORITY||LSM Difference|3.76|STANDARD_ERROR_OF_MEAN|1.122|=|0.0008|TWO_SIDED|95.0|1.56|5.97||Based on MMRM model with factors of age group, region, treatment, visit (First 7 Nights), and treatment-by-visit interaction as fixed effects, and the baseline sSE as a covariate.|MMRM|||sSE, First 7 nights: Placebo, Lemborexant 5 mg||5.97|1.56|= 0.0008
72591897|NCT02783729|144714866|SUPERIORITY||LSM Difference|6.84|STANDARD_ERROR_OF_MEAN|1.12|<|0.0001|TWO_SIDED|95.0|4.64|9.04||Based on MMRM model with factors of age group, region, treatment, visit (First 7 Nights), and treatment-by-visit interaction as fixed effects, and the baseline sSE as a covariate.|MMRM|||sSE, First 7 nights: Placebo, Lemborexant 10 mg||9.04|4.64|< 0.0001
72591898|NCT02783729|144714866|SUPERIORITY||LSM Difference|4.61|STANDARD_ERROR_OF_MEAN|1.319|=|0.0005|TWO_SIDED|95.0|2.02|7.19||Based on MMRM model with factors of age group, region, treatment, visit (Last 7 Nights), and treatment-by-visit interaction as fixed effects, and the baseline sSE as a covariate.|MMRM|||sSE, Last 7 nights: Placebo, Lemborexant 5 mg||7.19|2.02|= 0.0005
72591899|NCT02783729|144714866|SUPERIORITY||LSM Difference|7.18|STANDARD_ERROR_OF_MEAN|1.319|<|0.0001|TWO_SIDED|95.0|4.6|9.77||Based on MMRM model with factors of age group, region, treatment, visit (Last 7 Nights), and treatment-by-visit interaction as fixed effects, and the baseline sSE as a covariate.|MMRM|||sSE, Last 7 nights: Placebo, Lemborexant 10 mg||9.77|4.6|< 0.0001
72591900|NCT02783729|144714867|SUPERIORITY||Difference of Percentage|0.41|||=|0.9028|TWO_SIDED|95.0|-6.22|7.04||Based on Cochran-Mantel-Haenszel test stratified by age group.|Cochran-Mantel-Haenszel|||LPS, Days 1/2: Placebo, Lemborexant 5 mg||7.04|-6.22|= 0.9028
72591901|NCT02783729|144714867|SUPERIORITY||Difference of Percentage|2.49|||=|0.4699|TWO_SIDED|95.0|-4.2|9.18||Based on Cochran-Mantel-Haenszel test stratified by age group.|Cochran-Mantel-Haenszel|||LPS, Days 1/2: Placebo, Lemborexant 10 mg||9.18|-4.2|= 0.4699
72591902|NCT02783729|144714867|SUPERIORITY||Difference of Percentage|5.58|||=|0.0566|TWO_SIDED|95.0|-0.14|11.31|||Cochran-Mantel-Haenszel|Based on Cochran-Mantel-Haenszel test stratified by age group.||LPS, Days 1/2: Zolpidem ER, Lemborexant 5 mg||11.31|-0.14|= 0.0566
72591903|NCT02783729|144714867|SUPERIORITY||Difference of Percentage|7.57|||=|0.0122|TWO_SIDED|95.0|1.71|13.44||Based on Cochran-Mantel-Haenszel test stratified by age group.|Cochran-Mantel-Haenszel|||LPS, Days 1/2: Zolpidem ER, Lemborexant 10 mg||13.44|1.71|= 0.0122
72591904|NCT02783729|144714867|SUPERIORITY||Difference of Percentage|4.42|||=|0.2176|TWO_SIDED|95.0|-2.5|11.34||Based on Cochran-Mantel-Haenszel test stratified by age group.|Cochran-Mantel-Haenszel|||LPS, Days 29/30: Placebo, Lemborexant 5 mg||11.34|-2.5|= 0.2176
72591905|NCT02783729|144714867|SUPERIORITY||Difference of Percentage|6.47|||=|0.0773|TWO_SIDED|95.0|-0.55|13.49||Based on Cochran-Mantel-Haenszel test stratified by age group.|Cochran-Mantel-Haenszel|||LPS, Days 29/30: Placebo, Lemborexant 10 mg||13.49|-0.55|= 0.0773
72591906|NCT02783729|144714867|SUPERIORITY||Difference of Percentage|8.85|||=|0.0054|TWO_SIDED|95.0|2.68|15.02||Based on Cochran-Mantel-Haenszel test stratified by age group.|Cochran-Mantel-Haenszel|||LPS, Days 29/30: Zolpidem ER, Lemborexant 5 mg||15.02|2.68|= 0.0054
72591907|NCT02783729|144714867|SUPERIORITY||Difference of Percentage|10.89|||=|0.0008|TWO_SIDED|95.0|4.61|17.17||Based on Cochran-Mantel-Haenszel test stratified by age group.|Cochran-Mantel-Haenszel|||LPS, Days 29/30: Zolpidem ER, Lemborexant 10 mg||17.17|4.61|= 0.0008
72591908|NCT02783729|144714867|SUPERIORITY||Difference of Percentage|6.9|||=|0.003|TWO_SIDED|95.0|2.66|11.14||Based on Cochran-Mantel-Haenszel test stratified by age group.|Cochran-Mantel-Haenszel|||sSOL, First 7 nights: Placebo, Lemborexant 5 mg||11.14|2.66|= 0.003
72591909|NCT02783729|144714867|SUPERIORITY||Difference of Percentage|7.5|||=|0.0016|TWO_SIDED|95.0|3.19|11.81||Based on Cochran-Mantel-Haenszel test stratified by age group.|Cochran-Mantel-Haenszel|||sSOL, First 7 nights: Placebo, Lemborexant 10 mg||11.81|3.19|= 0.0016
72591910|NCT02783729|144714867|SUPERIORITY||Difference of Percentage|2.22|||=|0.3643|TWO_SIDED|95.0|-2.56|7.01||Based on Cochran-Mantel-Haenszel test stratified by age group.|Cochran-Mantel-Haenszel|||sSOL, First 7 nights: Zolpidem, Lemborexant 5 mg||7.01|-2.56|= 0.3643
72591911|NCT02783729|144714867|SUPERIORITY||Difference of Percentage|2.82|||=|0.2553|TWO_SIDED|95.0|-2.02|7.66||Based on Cochran-Mantel-Haenszel test stratified by age group.|Cochran-Mantel-Haenszel|||sSOL, First 7 nights: Zolpidem, Lemborexant 10 mg||7.66|-2.02|= 0.2553
72591912|NCT02783729|144714867|SUPERIORITY||Difference of Percentage|9.69|||=|0.0016|TWO_SIDED|95.0|3.98|15.4||Based on Cochran-Mantel-Haenszel test stratified by age group.|Cochran-Mantel-Haenszel|||sSOL, Last 7 nights: Placebo, Lemborexant 5 mg||15.4|3.98|= 0.0016
72591913|NCT02783729|144714867|SUPERIORITY||Difference of Percentage|7.29|||=|0.0128|TWO_SIDED|95.0|1.8|12.79||Based on Cochran-Mantel-Haenszel test stratified by age group.|Cochran-Mantel-Haenszel|||sSOL, Last 7 nights: Placebo, Lemborexant 10 mg||12.79|1.8|= 0.0128
72591914|NCT02783729|144714867|SUPERIORITY||Difference of Percentage|8.16|||=|0.0051|TWO_SIDED|95.0|2.51|13.81||Based on Cochran-Mantel-Haenszel test stratified by age group.|Cochran-Mantel-Haenszel|||sSOL, Last 7 nights: Zolpidem ER, Lemborexant 5 mg||13.81|2.51|= 0.0051
72591915|NCT02783729|144714867|SUPERIORITY||Difference of Percentage|5.76|||=|0.0389|TWO_SIDED|95.0|0.34|11.18||Based on Cochran-Mantel-Haenszel test stratified by age group.|Cochran-Mantel-Haenszel|||sSOL, Last 7nights: Zolpidem ER, Lemborexant 10 mg||11.18|0.34|= 0.0389
72591916|NCT02783729|144714867|SUPERIORITY||Difference of Percentage|34.26|||<|0.0001|TWO_SIDED|95.0|26.46|42.06||Based on Cochran-Mantel-Haenszel test stratified by age group.|Cochran-Mantel-Haenszel|||WASO, Days 1/2: Placebo, Lemborexant 5 mg||42.06|26.46|< 0.0001
72591917|NCT02783729|144714867|SUPERIORITY||Difference of Percentage|47.57|||<|0.0001|TWO_SIDED|95.0|40.02|55.13||Based on Cochran-Mantel-Haenszel test stratified by age group.|Cochran-Mantel-Haenszel|||WASO, Days 1/2: Placebo, Lemborexant 10 mg||55.13|40.02|< 0.0001
72591918|NCT02783729|144714867|SUPERIORITY||Difference of Percentage|4.89|||=|0.2534|TWO_SIDED|95.0|-3.49|13.28||Based on Cochran-Mantel-Haenszel test stratified by age group.|Cochran-Mantel-Haenszel|||WASO, Days 1/2: Zolpidem ER, Lemborexant 5 mg||13.28|-3.49|= 0.2534
72591919|NCT02783729|144714867|SUPERIORITY||Difference of Percentage|18.25|||<|0.0001|TWO_SIDED|95.0|10.1|26.4||Based on Cochran-Mantel-Haenszel test stratified by age group.|Cochran-Mantel-Haenszel|||WASO: Days 1/2: Zolpidem ER, Lemborexant 10 mg||26.4|10.1|< 0.0001
72591920|NCT02783729|144714867|SUPERIORITY||Difference of Percentage|22.2|||<|0.0001|TWO_SIDED|95.0|14.06|30.35||Based on Cochran-Mantel-Haenszel test stratified by age group.|Cochran-Mantel-Haenszel|||WASO, Days 29/30: Placebo, Lemborexant 5 mg||30.35|14.06|< 0.0001
72414521|NCT00321854|144338881|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.0|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001||95.0|-1.5|-0.6|||ANCOVA|||||-0.6|-1.5|<0.0001
72414522|NCT00321854|144338882|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.3|STANDARD_ERROR_OF_MEAN|0.1||0.0376||95.0|-0.5|0.0|||ANCOVA|||||0|-0.5|0.0376
72591921|NCT02783729|144714867|SUPERIORITY||Difference of Percentage|24.13|||<|0.0001|TWO_SIDED|95.0|16.16|32.1||Based on Cochran-Mantel-Haenszel test stratified by age group.|Cochran-Mantel-Haenszel|||WASO, Days 29/30: Placebo, Lemborexant 10 mg||32.1|16.16|< 0.0001
72591922|NCT02783729|144714867|SUPERIORITY||Difference of Percentage|9.59|||=|0.023|TWO_SIDED|95.0|1.36|17.81||Based on Cochran-Mantel-Haenszel test stratified by age group.|Cochran-Mantel-Haenszel|||WASO, Days 29/30: Zolpidem ER, Lemborexant 5 mg||17.81|1.36|= 0.023
72591923|NCT02783729|144714867|SUPERIORITY||Difference of Percentage|11.43|||=|0.0058|TWO_SIDED|95.0|3.38|19.48||Based on Cochran-Mantel-Haenszel test stratified by age group.|Cochran-Mantel-Haenszel|||WASO, Days 29/30: Zolpidem ER, Lemborexant 10 mg||19.48|3.38|= 0.0058
72591924|NCT02783729|144714867|SUPERIORITY||Difference of Percentage|7.3|||=|0.0222|TWO_SIDED|95.0|1.27|13.33||Based on Cochran-Mantel-Haenszel test stratified by age group.|Cochran-Mantel-Haenszel|||sWASO, First 7 nights: Placebo, Lemborexant 5||13.33|1.27|= 0.0222
72591925|NCT02783729|144714867|SUPERIORITY||Difference of Percentage|10.84|||=|0.0013|TWO_SIDED|95.0|4.57|17.11||Based on Cochran-Mantel-Haenszel test stratified by age group.|Cochran-Mantel-Haenszel|||sWASO, First 7 nights: Placebo, Lemborexant 10 mg||17.11|4.57|= 0.0013
72591926|NCT02783729|144714867|SUPERIORITY||Difference of Percentage|0.21|||=|0.9495|TWO_SIDED|95.0|-6.17|6.58||Based on Cochran-Mantel-Haenszel test stratified by age group.|Cochran-Mantel-Haenszel|||sWASO, First 7 nights: Zolpidem ER, Lemborexant 5 mg||6.58|-6.17|= 0.9495
72591927|NCT02783729|144714867|SUPERIORITY||Difference of Percentage|3.72|||=|0.2708|TWO_SIDED|95.0|-2.88|10.32||Based on Cochran-Mantel-Haenszel test stratified by age group.|Cochran-Mantel-Haenszel|||sWASO: First 7 nights: Zolpidem ER, Lemborexant 10 mg||10.32|-2.88|= 0.2708
72591928|NCT02783729|144714867|SUPERIORITY||Difference of Percentage|7.91|||=|0.0322|TWO_SIDED|95.0|0.86|14.96||Based on Cochran-Mantel-Haenszel test stratified by age group.|Cochran-Mantel-Haenszel|||sWASO, Last 7 nights: Placebo, Lemborexant 5 mg||14.96|0.86|= 0.0322
72591929|NCT02783729|144714867|SUPERIORITY||Difference of Percentage|7.69|||=|0.0363|TWO_SIDED|95.0|0.68|14.71||Based on Cochran-Mantel-Haenszel test stratified by age group.|Cochran-Mantel-Haenszel|||sWASO, Last 7 nights: Placebo, Lemborexant 10 mg||14.71|0.68|= 0.0363
72591930|NCT02783729|144714867|SUPERIORITY||Difference of Percentage|0.05|||=|0.9885|TWO_SIDED|95.0|-7.14|7.24||Based on Cochran-Mantel-Haenszel test stratified by age group.|Cochran-Mantel-Haenszel|||sWASO, Last 7 nights: Zolpidem ER, Lemborexant 5 mg||7.24|-7.14|= 0.9885
72414523|NCT00321854|144338883|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.2|STANDARD_ERROR_OF_MEAN|0.1||0.1607||95.0|-0.4|0.1|||ANCOVA|||||0.1|-0.4|0.1607
72591931|NCT02783729|144714867|SUPERIORITY||Difference of Percentage|-0.16|||=|0.9651|TWO_SIDED|95.0|-7.31|6.99||Based on Cochran-Mantel-Haenszel test stratified by age group.|Cochran-Mantel-Haenszel|||sWASO, Last 7 nights: Zolpidem ER, Lemborexant 10 mg||6.99|-7.31|= 0.9651
72591932|NCT02783729|144714868|SUPERIORITY||LSM Difference|-1.1|STANDARD_ERROR_OF_MEAN|0.319|=|0.0006|TWO_SIDED|95.0|-1.73|-0.47||Based on ANCOVA model with factors of age group, region, treatment and the baseline ISI as a covariate.|ANCOVA|||Placebo, Lemborexant 5 mg||-0.47|-1.73|= 0.0006
72591933|NCT02783729|144714868|SUPERIORITY||LSM Difference|-1.08|STANDARD_ERROR_OF_MEAN|0.32|=|0.0007|TWO_SIDED|95.0|-1.71|-0.46||Based on ANCOVA model with factors of age group, region, treatment and the baseline ISI as a covariate.|ANCOVA|||Placebo, Lemborexant 10 mg||-0.46|-1.71|= 0.0007
72591934|NCT02783729|144714868|SUPERIORITY||LSM Difference|0.32|STANDARD_ERROR_OF_MEAN|0.301|=|0.2951|TWO_SIDED|95.0|-0.28|0.91||Based on ANCOVA model with factors of age group, region, treatment and the baseline ISI as a covariate.|ANCOVA|||Zolpidem ER, Lemborexant 5 mg||0.91|-0.28|= 0.2951
72591935|NCT02783729|144714868|SUPERIORITY||LSM Difference|0.33|STANDARD_ERROR_OF_MEAN|0.303|=|0.2744|TWO_SIDED|95.0|-0.26|0.92||Based on ANCOVA model with factors of age group, region, treatment and the baseline ISI as a covariate.|ANCOVA|||Zolpidem ER, Lemborexant 10 mg||0.92|-0.26|= 0.2744
72591936|NCT02783729|144714869|SUPERIORITY||LSM Difference|-1.26|STANDARD_ERROR_OF_MEAN|1.063|=|0.2348|TWO_SIDED|95.0|-3.35|0.82||Based on ANCOVA model with factors of age group, region, treatment and the baseline FSS as a covariate.|ANCOVA|||Placebo, Lemborexant 5 mg||0.82|-3.35|= 0.2348
72591937|NCT02783729|144714869|SUPERIORITY||LSM Difference|-1.17|STANDARD_ERROR_OF_MEAN|1.067|=|0.2745|TWO_SIDED|95.0|-3.26|0.93||Based on ANCOVA model with factors of age group, region, treatment and the baseline FSS as a covariate.|ANCOVA|||Placebo, Lemborexant 10 mg||0.93|-3.26|= 0.2745
72591938|NCT02783729|144714869|SUPERIORITY||LSM Difference|-0.37|STANDARD_ERROR_OF_MEAN|1.005|=|0.711|TWO_SIDED|95.0|-2.35|1.6||Based on ANCOVA model with factors of age group, region, treatment and the baseline ISI as a covariate.|ANCOVA|||Zolpidem ER, Lemborexant 5 mg||1.6|-2.35|= 0.711
72591939|NCT02783729|144714869|SUPERIORITY||LSM Difference|-0.27|STANDARD_ERROR_OF_MEAN|1.009|=|0.7854|TWO_SIDED|95.0|-2.26|1.71||Based on ANCOVA model with factors of age group, region, treatment and the baseline ISI as a covariate.|ANCOVA|||Zolpidem ER, Lemborexant 10 mg||1.71|-2.26|= 0.7854
72591940|NCT02783729|144714870|SUPERIORITY||LSM Difference|30.77|STANDARD_ERROR_OF_MEAN|12.505|=|0.0141|TWO_SIDED|95.0|6.23|55.31||Based on MMRM model with factors of age group, region, treatment, visit (Days 2/3), and treatment-by-visit interaction as fixed effects, and the baseline POA as a covariate.|MMRM|||POA: Placebo, Lemborexant 5 mg||55.31|6.23|= 0.0141
72591941|NCT02783729|144714870|SUPERIORITY||LSM Difference|39.67|STANDARD_ERROR_OF_MEAN|12.542|=|0.0016|TWO_SIDED|95.0|15.05|64.29||Based on MMRM model with factors of age group, region, treatment, visit (Days 2/3), and treatment-by-visit interaction as fixed effects, and the baseline POA as a covariate.|MMRM|||POA: Placebo, Lemborexant 10 mg||64.29|15.05|= 0.0016
72591942|NCT02783729|144714870|SUPERIORITY||LSM Difference|-19.22|STANDARD_ERROR_OF_MEAN|11.779|=|0.1031|TWO_SIDED|95.0|-42.34|3.9||Based on MMRM model with factors of age group, region, treatment, visit (Days 2/3), and treatment-by-visit interaction as fixed effects, and the baseline POA as a covariate.|MMRM|||POA: Zolpidem ER, Lemborexant 5 mg||3.9|-42.34|= 0.1031
72591943|NCT02783729|144714870|SUPERIORITY||LSM Difference|-10.32|STANDARD_ERROR_OF_MEAN|11.813|=|0.3825|TWO_SIDED|95.0|-33.5|12.86||Based on MMRM model with factors of age group, region, treatment, visit (Days 2/3), and treatment-by-visit interaction as fixed effects, and the baseline POA as a covariate.|MMRM|||POA: Zolpidem ER, Lemborexant 10 mg||12.86|-33.5|= 0.3825
72591944|NCT02783729|144714870|SUPERIORITY||LSM Difference|28.81|STANDARD_ERROR_OF_MEAN|60.626|=|0.6348|TWO_SIDED|95.0|-90.18|147.8||Based on MMRM model with factors of age group, region, treatment, visit (Days 2/3), and treatment-by-visit interaction as fixed effects, and the baseline SOMT as a covariate.|MMRM|||SOMT: Placebo, Lemborexant 5 mg||147.8|-90.18|= 0.6348
72591945|NCT02783729|144714870|SUPERIORITY||LSM Difference|50.83|STANDARD_ERROR_OF_MEAN|60.702|=|0.4026|TWO_SIDED|95.0|-68.3|169.97||Based on MMRM model with factors of age group, region, treatment, visit (Days 2/3), and treatment-by-visit interaction as fixed effects, and the baseline SOMT as a covariate.|MMRM|||SOMT: Placebo, Lemborexant 10 mg||169.97|-68.3|= 0.4026
72591946|NCT02783729|144714870|SUPERIORITY||LSM Difference|-203.36|STANDARD_ERROR_OF_MEAN|57.171|=|0.0004|TWO_SIDED|95.0|-315.56|-91.15||Based on MMRM model with factors of age group, region, treatment, visit (Days 2/3), and treatment-by-visit interaction as fixed effects, and the baseline SOMT as a covariate.|MMRM|||SOMT: Zolpidem ER, Lemborexant 5 mg||-91.15|-315.56|= 0.0004
72591947|NCT02783729|144714870|SUPERIORITY||LSM Difference|-181.33|STANDARD_ERROR_OF_MEAN|57.255|=|0.0016|TWO_SIDED|95.0|-293.71|-68.96||Based on MMRM model with factors of age group, region, treatment, visit (Days 2/3), and treatment-by-visit interaction as fixed effects, and the baseline SOMT as a covariate.|MMRM|||SOMT: Zolpidem ER, Lemborexant 10 mg||-68.96|-293.71|= 0.0016
72591948|NCT02783729|144714871|SUPERIORITY||LSM Difference|-0.03|STANDARD_ERROR_OF_MEAN|4.141|=|0.9936|TWO_SIDED|95.0|-8.16|8.09||Based on MMRM model with factors of age group, region, treatment, visit (Days 2/3), and treatment-by-visit interaction as fixed effects, and the baseline QOM as a covariate.|MMRM|||QOM: Placebo, Lemborexant 5 mg||8.09|-8.16|= 0.9936
72591949|NCT02783729|144714871|SUPERIORITY||LSM Difference|-5.85|STANDARD_ERROR_OF_MEAN|4.154|=|0.1595|TWO_SIDED|95.0|-14.0|2.3||Based on MMRM model with factors of age group, region, treatment, visit (Days 2/3), and treatment-by-visit interaction as fixed effects, and the baseline QOM as a covariate.|MMRM|||QOM: Placebo, Lemborexant 10 mg||2.3|-14|= 0.1595
72591950|NCT02783729|144714871|SUPERIORITY||LSM Difference|12.73|STANDARD_ERROR_OF_MEAN|3.894|=|0.0011|TWO_SIDED|95.0|5.09|20.38||Based on MMRM model with factors of age group, region, treatment, visit (Days 2/3), and treatment-by-visit interaction as fixed effects, and the baseline QOM as a covariate.|MMRM|||QOM: Zolpidem ER, Lemborexant 5 mg||20.38|5.09|= 0.0011
72591951|NCT02783729|144714871|SUPERIORITY||LSM Difference|6.92|STANDARD_ERROR_OF_MEAN|3.913|=|0.0774|TWO_SIDED|95.0|-0.76|14.6||Based on MMRM model with factors of age group, region, treatment, visit (Days 2/3), and treatment-by-visit interaction as fixed effects, and the baseline QOM as a covariate.|MMRM|||QOM: Zolpidem ER, Lemborexant 10 mg||14.6|-0.76|= 0.0774
72591952|NCT02783729|144714871|SUPERIORITY||LSM Difference|0.35|STANDARD_ERROR_OF_MEAN|0.393|=|0.3726|TWO_SIDED|95.0|-0.42|1.12||Based on MMRM model with factors of age group, region, treatment, visit (Days 2/3), and treatment-by-visit interaction as fixed effects, and the baseline COA as a covariate.|MMRM|||COA: Placebo, Lemborexant 5 mg||1.12|-0.42|= 0.3726
72591953|NCT02783729|144714871|SUPERIORITY||LSM Difference|-0.45|STANDARD_ERROR_OF_MEAN|0.394|=|0.2579|TWO_SIDED|95.0|-1.22|0.33||Based on MMRM model with factors of age group, region, treatment, visit (Days 2/3), and treatment-by-visit interaction as fixed effects, and the baseline COA as a covariate.|MMRM|||COA: Placebo, Lemborexant 10 mg||0.33|-1.22|= 0.2579
72591954|NCT02783729|144714871|SUPERIORITY||LSM Difference|1.39|STANDARD_ERROR_OF_MEAN|0.37|=|0.0002|TWO_SIDED|95.0|0.66|2.11||Based on MMRM model with factors of age group, region, treatment, visit (Days 2/3), and treatment-by-visit interaction as fixed effects, and the baseline COA as a covariate.|MMRM|||COA: Zolpidem ER, Lemborexant 5 mg||2.11|0.66|= 0.0002
72591955|NCT02783729|144714871|SUPERIORITY||LSM Difference|0.59|STANDARD_ERROR_OF_MEAN|0.372|=|0.112|TWO_SIDED|95.0|-0.14|1.32||Based on MMRM model with factors of age group, region, treatment, visit (Days 2/3), and treatment-by-visit interaction as fixed effects, and the baseline COA as a covariate.|MMRM|||COA: Zolpidem ER, Lemborexant 10 mg||1.32|-0.14|= 0.112
72591956|NCT05870956|144714979|OTHER||Mean Difference (Net)|932.88||||0.516|TWO_SIDED|95.0|-1880.17|3745.94|||ANOVA||"The net difference was calculated as:~Comparator - Reference~where High nintedanib adherence group was used as reference."|||3745.94|-1880.17|0.516
72591957|NCT05870956|144714979|OTHER||Mean Difference (Net)|4902.02||||0.02|TWO_SIDED|95.0|767.6|9036.43|||ANOVA||"The net difference was calculated as:~Comparator - Reference~where High nintedanib adherence group was used as reference."|||9036.43|767.60|0.020
72591958|NCT05870956|144714979|OTHER||Mean Difference (Net)|2727.38||||0.026|TWO_SIDED|95.0|323.48|5131.27|||ANOVA||"The net difference was calculated as:~Comparator - Reference~where High nintedanib adherence group was used as reference."|||5131.27|323.48|0.026
72591959|NCT05870956|144714979|OTHER||Mean Difference (Net)|5462.41||||0|TWO_SIDED|95.0|2520.93|8403.9|||ANOVA||"The net difference was calculated as:~Comparator - Reference~where High nintedanib adherence group was used as reference."|||8403.90|2520.93|0.000
72414524|NCT00321854|144338884|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.3|STANDARD_ERROR_OF_MEAN|0.1||0.0173||95.0|-0.5|-0.1|||ANCOVA|||||-0.1|-0.5|0.0173
72591960|NCT05870956|144714980|OTHER||Mean Difference (Net)|-303.94||||0.439|TWO_SIDED|95.0|-1074.77|466.9|||ANOVA||"The net difference was calculated as:~Comparator - Reference~where High nintedanib adherence group was used as reference."|||466.90|-1074.77|0.439
72591961|NCT05870956|144714980|OTHER||Mean Difference (Net)|2772.06||||0.021|TWO_SIDED|95.0|422.1|5122.02|||ANOVA||"The net difference was calculated as:~Comparator - Reference~where High nintedanib adherence group was used as reference."|||5122.02|422.10|0.021
72591962|NCT05870956|144714980|OTHER||Mean Difference (Net)|456.79||||0.328|TWO_SIDED|95.0|-458.64|1372.21|||ANOVA||"The net difference was calculated as:~Comparator - Reference~where High nintedanib adherence group was used as reference."|||1372.21|-458.64|0.328
72591963|NCT05870956|144714980|OTHER||Mean Difference (Net)|620.87||||0.382|TWO_SIDED|95.0|-771.77|2013.51|||ANOVA||"The net difference was calculated as:~Comparator - Reference~where High nintedanib adherence group was used as reference."|||2013.51|-771.77|0.382
72591964|NCT05870956|144714981|OTHER||Mean Difference (Net)|2.4||||0.463|TWO_SIDED|95.0|-4.0|8.9|||Chi-squared||"The net difference was calculated as:~Comparator - Reference~where High nintedanib adherence group was used as reference."|||8.9|-4.0|0.463
72591965|NCT05870956|144714981|OTHER||Mean Difference (Net)|9.6||||0.008|TWO_SIDED|95.0|2.5|16.8|||Chi-squared||"The net difference was calculated as:~Comparator - Reference~where High nintedanib adherence group was used as reference."|||16.8|2.5|0.008
72591966|NCT05870956|144714981|OTHER||Mean Difference (Net)|9.1||||0.005|TWO_SIDED|95.0|2.8|15.3|||Chi-squared||"The net difference was calculated as:~Comparator - Reference~where High nintedanib adherence group was used as reference."|||15.3|2.8|0.005
72591967|NCT05870956|144714981|OTHER||Mean Difference (Net)|6.4||||0.019|TWO_SIDED|95.0|1.1|11.7|||Chi-squared||"The net difference was calculated as:~Comparator - Reference~where High nintedanib adherence group was used as reference."|||11.7|1.1|0.019
72591968|NCT05870956|144714982|OTHER||Mean Difference (Net)|0.6||||0.801|TWO_SIDED|95.0|-4.3|5.5|||Chi-squared||"The net difference was calculated as:~Comparator - Reference~where High nintedanib adherence group was used as reference."|||5.5|-4.3|0.801
72591969|NCT05870956|144714982|OTHER||Mean Difference (Net)|8.7||||0.005|TWO_SIDED|95.0|2.7|14.8|||Chi-squared||"The net difference was calculated as:~Comparator - Reference~where High nintedanib adherence group was used as reference."|||14.8|2.7|0.005
72591970|NCT05870956|144714982|OTHER||Mean Difference (Net)|3.4||||0.17|TWO_SIDED|95.0|-1.4|8.2|||Chi-squared||"The net difference was calculated as:~Comparator - Reference~where High nintedanib adherence group was used as reference."|||8.2|-1.4|0.170
72591971|NCT05870956|144714982|OTHER||Mean Difference (Net)|1.4||||0.489|TWO_SIDED|95.0|-2.6|5.4|||Chi-squared||"The net difference was calculated as:~Comparator - Reference~where High nintedanib adherence group was used as reference."|||5.4|-2.6|0.489
72591972|NCT02880865|144714983|NON_INFERIORITY|Non-inferiority was achieved if the lower limit of the two-sided 95% confidence interval (CI) for the difference in percentages of participants with seropositivity between the two groups (concurrent administration minus separate administration) at 56 days post-vaccination was \> -10% for both measles and rubella results.|Difference|0.0|||||TWO_SIDED|95.0|-2.1|2.2||||||The primary hypotheses evaluated the non-inferiority of the concomitant administration of MMR and CD-JEV vaccines (Group 1) to MMR and CD-JEV vaccines given 2 months apart (Group 2) in children 9 months of age at 56 days in terms of percentage of participants achieving seropositivity to measles and rubella assuming a non-inferiority margin of 10%.||2.2|-2.1|
72591973|NCT02880865|144714984|NON_INFERIORITY|Non-inferiority was achieved if the lower limit of the two-sided 95% CI for the difference in percentages of participants with seropositivity between the two groups (concurrent administration minus separate administration) at 56 days post-vaccination was \> -10% for both measles and rubella results.|Difference|0.3|||||TWO_SIDED|95.0|-0.3|1.0||||||The primary hypotheses evaluated the non-inferiority of the concomitant administration of MMR and CD-JEV vaccines (Group 1) to MMR and CD-JEV vaccines given 2 months apart (Group 2) in children 9 months of age at 56 days in terms of percentage of participants achieving seropositivity to measles and rubella assuming a non-inferiority margin of 10%.||1.0|-0.3|
72591974|NCT02880865|144714985|NON_INFERIORITY|The percentage of participants with seropositivity for mumps at 56 days post-vaccination between Group 1 and Group 2 were compared using a non-inferiority test. Non-inferiority of Group 1 to Group 2 in terms of seropositivity for mumps was demonstrated if the lower limit of the two-sided 95% CI for the difference of seropositivity rates between the two groups (concurrent administration minus separate administration) at 56 days post-vaccination was \> -10%.|Difference|0.0|||||TWO_SIDED|95.0|-2.0|2.1||||||||2.1|-2.0|
72591975|NCT02880865|144714986|OTHER||GMC Ratio|1.1|||||TWO_SIDED|95.0|0.9|1.2|||||Group 1/Group 2 ratio obtained using analysis of covariance (ANCOVA) with log10-transformed antibody concentration as dependent variable and treatment group as the explanatory variable adjusted for log10-transformed baseline antibody concentration.|||1.2|0.9|
72414525|NCT00321854|144338885|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.4|STANDARD_ERROR_OF_MEAN|0.1||0.0007||95.0|-0.6|-0.2|||ANCOVA|||||-0.2|-0.6|0.0007
72591976|NCT02880865|144714987|OTHER||GMC Ratio|1.0|||||TWO_SIDED|95.0|0.9|1.1|||||Group 1/Group 2 ratio obtained using an ANCOVA method with log 10-transformed antibody concentration as dependent variable and treatment group as explanatory variable adjusted for log 10-transformed baseline antibody concentration.|||1.1|0.9|
72591977|NCT02880865|144714988|OTHER||Difference|0.0|||||TWO_SIDED|95.0|-2.1|2.2|||||Group 1 - Group 2|||2.2|-2.1|
72591978|NCT02880865|144714989|OTHER||Difference|1.6|||||TWO_SIDED|95.0|-1.8|4.9|||||Group 1 - Group 2|||4.9|-1.8|
72591979|NCT02880865|144714990|OTHER||Difference|0.3|||||TWO_SIDED|95.0|-0.3|1.0|||||Group 1 - Group 2|||1.0|-0.3|
72414526|NCT00321854|144338886|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1|STANDARD_ERROR_OF_MEAN|0.1||0.4381||95.0|-0.3|0.1|||ANCOVA|||||0.1|-0.3|0.4381
72414527|NCT00321854|144338887|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.796||||0.5116||95.0|0.403|1.573|||Regression, Logistic|||||1.573|0.403|0.5116
72591980|NCT02880865|144714991|OTHER||Difference|4.1|||||TWO_SIDED|95.0|-3.1|11.3||||||||11.3|-3.1|
72591981|NCT02880865|144714992|OTHER||GMT Ratio|1.2|||||TWO_SIDED|95.0|1.0|1.4|||||Group 1 / Group 2 ratio obtained using an analysis of covariance (ANCOVA) method with log 10-transformed antibody concentration as dependent variable and treatment group as explanatory variable adjusted for log 10-transformed baseline antibody titer.|||1.4|1.0|
72591982|NCT03724877|144714999|OTHER||Adjusted hazard ratio (HR)|1.04|||||TWO_SIDED|95.0|0.79|1.38|||Regression, Cox||After matching on high-dimensional propensity scores, sex prior severe exacerbation, prior maintenance treatment and calendar time, adjusted further for the deciles of propensity score and percent predicted forced expiratory volume1 (FEV1).|||1.38|0.79|
72591983|NCT03724877|144715000|OTHER||Adjusted HR|0.97|||||TWO_SIDED|95.0|0.87|1.09|||Regression, Cox||After matching on high-dimensional propensity scores, sex prior severe exacerbation, prior maintenance treatment and calendar time, adjusted further for the deciles of propensity score and percent predicted FEV1.|||1.09|0.87|
72591984|NCT03724877|144715001|OTHER||Adjusted HR|1.46|||||TWO_SIDED|95.0|1.03|2.07|||Regression, Cox||After matching on high-dimensional propensity scores, sex prior severe exacerbation, prior maintenance treatment and calendar time, adjusted further for the deciles of propensity score and percent predicted FEV1.|||2.07|1.03|
72591985|NCT03724877|144715002|OTHER||Adjusted rate ratio|0.93|||||TWO_SIDED|95.0|0.83|1.04|||Negative binomial regression model||After matching on high-dimensional propensity scores, sex prior severe exacerbation, prior maintenance treatment and calendar time, adjusted further for the deciles of propensity score and percent predicted FEV1.|Moderate/ sever exacerbation||1.04|0.83|
72591986|NCT03724877|144715002|OTHER||Adjusted rate ratio|0.94|||||TWO_SIDED|95.0|0.7|1.28|||Negative binomial regression model||After matching on high-dimensional propensity scores, sex prior severe exacerbation, prior maintenance treatment and calendar time, adjusted further for the deciles of propensity score and percent predicted FEV1.|Severe exacerbation||1.28|0.70|
72591987|NCT01056198|144715015|SUPERIORITY_OR_OTHER||||||=|0.208||95.0|||||ANCOVA|||The BWAT-m scores were compared at each of the 4 treatment weeks and at the end of the follow-up using a mixed-effects ANCOVA for the intent-to-treat population. Treatment and treatment week, as well as their interaction, were defined as fixed effects with subject as a random effect. The BWAT-m score at baseline was used as a covariate.||||=0.208
72591988|NCT01056198|144715016|SUPERIORITY_OR_OTHER||||||=|0.2737||95.0|||||ANCOVA|||Null hypothesis: no differences between the 2 treatments with the alternative of non-zero differences. 48 evaluable subjects is sufficient to detect an effect size of 0.80.||||=0.2737
72591989|NCT01056198|144715017|SUPERIORITY_OR_OTHER||||||=|0.2741||95.0|||||ANCOVA|||Null hypothesis: no differences between the 2 treatments with the alternative of non-zero differences. 48 evaluable subjects is sufficient to detect an effect size of 0.80.||||=0.2741
72591990|NCT01056198|144715018|SUPERIORITY_OR_OTHER||||||=|0.0164||95.0|||||t-test, 2 sided|||Paired t-test, 2-sided, alpha = 0.05||||=0.0164
72591991|NCT01056198|144715019|SUPERIORITY_OR_OTHER||||||=|0.9392||95.0|||||t-test, 2 sided|||Paired t-test, 2-sided, alpha = 0.05||||=0.9392
72591992|NCT00742508|144715024|SUPERIORITY_OR_OTHER||Mean Difference (Net)|9.38|STANDARD_ERROR_OF_MEAN|5.449|||TWO_SIDED|95.0|-5.75|24.51|||||The mean treatment difference is calculated as SK\&F-105517-D minus CRV-IR for the 24 h assessment.|||24.51|-5.75|
72591993|NCT00742508|144715024|SUPERIORITY_OR_OTHER||Median Difference (Net)|7.55|STANDARD_ERROR_OF_MEAN|5.849|||TWO_SIDED|95.0|-8.68|23.79|||||The mean treatment difference is calculated as SK\&F-105517-D minus CRV-IR for the Morning assessment.|||23.79|-8.68|
72414528|NCT00321854|144338888|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.153||||0.7913||95.0|0.403|3.299|||Regression, Logistic|||The ordinal responses (3 levels) were analysed using the proportional odds model extension of logistic regression||3.299|0.403|0.7913
72591994|NCT00742508|144715024|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.92|STANDARD_ERROR_OF_MEAN|3.645|||TWO_SIDED|95.0|-12.04|8.2|||||The mean treatment difference is calculated as SK\&F-105517-D minus CRV-IR for the Afternoon assessment.|||8.20|-12.04|
72591995|NCT00742508|144715024|SUPERIORITY_OR_OTHER||Mean Difference (Net)|14.21|STANDARD_ERROR_OF_MEAN|6.361|||TWO_SIDED|95.0|-3.45|31.87|||||The mean treatment difference is calculated as SK\&F-105517-D minus CRV-IR for the Night assessment.|||31.87|-3.45|
72591996|NCT00742508|144715024|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.4|STANDARD_ERROR_OF_MEAN|3.79|||TWO_SIDED|95.0|-10.12|10.92|||||The mean treatment difference is calculated as SK\&F-105517-D minus CRV-IR for the Waking assessment.|||10.92|-10.12|
72591997|NCT00742508|144715024|SUPERIORITY_OR_OTHER||Mean Difference (Net)|25.04|STANDARD_ERROR_OF_MEAN|4.281|||TWO_SIDED|95.0|13.16|36.93|||||The mean treatment difference is calculated as SK\&F-105517-D minus CRV-IR for the Sleeping assessment.|||36.93|13.16|
72414529|NCT00321854|144338889|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.5|STANDARD_ERROR_OF_MEAN|0.4||0.1702||95.0|-1.3|0.2|||ANCOVA|||||0.2|-1.3|0.1702
72591998|NCT00742508|144715024|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.45|STANDARD_ERROR_OF_MEAN|10.62||||95.0|-29.94|29.03|||||The mean treatment difference is calculated as SK\&F-105517-D minus CRV-IR for the PDmax assessment.|||29.03|-29.94|
72591999|NCT00742508|144715024|SUPERIORITY_OR_OTHER||Mean Difference (Net)|8.31|STANDARD_ERROR_OF_MEAN|7.194|||TWO_SIDED|95.0|-11.67|28.28|||||The mean treatment difference is calculated as SK\&F-105517-D minus CRV-IR for the PDmin assessment.|||28.28|-11.67|
72592000|NCT00742508|144715024|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.24|STANDARD_ERROR_OF_MEAN|0.142|||TWO_SIDED|95.0|-0.63|0.15|||||The mean treatment difference is calculated as SK\&F-105517-D minus CRV-IR for the PDmax/PDmin assessment.|||0.15|-0.63|
72592001|NCT00742508|144715044|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.21|STANDARD_ERROR_OF_MEAN|4.833|||TWO_SIDED|95.0|-11.2|15.63|||||The mean treatment difference is calculated as SK\&F-105517-D minus CRV-IR for the 24 h assessment.|||15.63|-11.20|
72592002|NCT00742508|144715044|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.56|STANDARD_ERROR_OF_MEAN|6.265|||TWO_SIDED|95.0|-17.95|16.84|||||The mean treatment difference is calculated as SK\&F-105517-D minus CRV-IR for the Morning assessment.|||16.84|-17.95|
72592003|NCT00742508|144715044|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.93|STANDARD_ERROR_OF_MEAN|3.885|||TWO_SIDED|95.0|-15.71|5.86|||||The mean treatment difference is calculated as SK\&F-105517-D minus CRV-IR for the Afternoon assessment.|||5.86|-15.71|
72592004|NCT00742508|144715044|SUPERIORITY_OR_OTHER||Mean Difference (Net)|9.74|STANDARD_ERROR_OF_MEAN|6.07|||TWO_SIDED|95.0|-7.11|26.59|||||The mean treatment difference is calculated as SK\&F-105517-D minus CRV-IR for the Night assessment.|||26.59|-7.11|
72592005|NCT00742508|144715044|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.45|STANDARD_ERROR_OF_MEAN|4.08|||TWO_SIDED|95.0|-14.78|7.88|||||The mean treatment difference is calculated as SK\&F-105517-D minus CRV-IR for the Waking assessment.|||7.88|-14.78|
72592006|NCT00742508|144715044|SUPERIORITY_OR_OTHER||Mean Difference (Net)|18.06|STANDARD_ERROR_OF_MEAN|1.694|||TWO_SIDED|95.0|13.36|22.76|||||The mean treatment difference is calculated as SK\&F-105517-D minus CRV-IR for the Sleeping assessment.|||22.76|13.36|
72592007|NCT00742508|144715044|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-7.46|STANDARD_ERROR_OF_MEAN|8.902|||TWO_SIDED|95.0|-32.17|17.26|||||The mean treatment difference is calculated as SK\&F-105517-D minus CRV-IR for the PDmax assessment.|||17.26|-32.17|
72592008|NCT00742508|144715044|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.1|STANDARD_ERROR_OF_MEAN|5.297|||TWO_SIDED|95.0|-13.61|15.8|||||The mean treatment difference is calculated as SK\&F-105517-D minus CRV-IR for the PDmin assessment.|||15.80|-13.61|
72592009|NCT00742508|144715044|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.12|STANDARD_ERROR_OF_MEAN|0.152|||TWO_SIDED|95.0|-0.54|0.3|||||The mean treatment difference is calculated as SK\&F-105517-D minus CRV-IR for the PDmax/PDmin assessment.|||0.30|-0.54|
72592010|NCT00742508|144715045|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.99|STANDARD_ERROR_OF_MEAN|3.187|||TWO_SIDED|95.0|-12.84|4.86|||||The mean treatment difference is calculated as SK\&F-105517-D minus CRV-IR for the 24 h assessment.|||4.86|-12.84|
72592011|NCT00742508|144715045|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.27|STANDARD_ERROR_OF_MEAN|2.962|||TWO_SIDED|95.0|-13.5|2.95|||||The mean treatment difference is calculated as SK\&F-105517-D minus CRV-IR for the Morning assessment.|||2.95|-13.50|
72592012|NCT00742508|144715045|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.98|STANDARD_ERROR_OF_MEAN|3.209|||TWO_SIDED|95.0|-10.89|6.94|||||The mean treatment difference is calculated as SK\&F-105517-D minus CRV-IR for the Afternoon assessment.|||6.94|-10.89|
72592013|NCT00742508|144715045|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.14|STANDARD_ERROR_OF_MEAN|3.665|||TWO_SIDED|95.0|-14.32|6.03|||||The mean treatment difference is calculated as SK\&F-105517-D minus CRV-IR for the Night assessment.|||6.03|-14.32|
72592014|NCT00742508|144715045|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.99|STANDARD_ERROR_OF_MEAN|3.047|||TWO_SIDED|95.0|-11.45|5.47|||||The mean treatment difference is calculated as SK\&F-105517-D minus CRV-IR for the Waking assessment.|||5.47|-11.45|
72592015|NCT00742508|144715045|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.11|STANDARD_ERROR_OF_MEAN|4.686|||TWO_SIDED|95.0|-16.12|9.89|||||The mean treatment difference is calculated as SK\&F-105517-D minus CRV-IR for the Sleeping assessment.|||9.89|-16.12|
72592016|NCT00742508|144715045|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-10.0|STANDARD_ERROR_OF_MEAN|3.749|||TWO_SIDED|95.0|-20.41|0.41|||||The mean treatment difference is calculated as SK\&F-105517-D minus CRV-IR for the PDmax assessment.|||0.41|-20.41|
72592017|NCT00742508|144715045|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.42|STANDARD_ERROR_OF_MEAN|5.249|||TWO_SIDED|95.0|-16.0|13.15|||||The mean treatment difference is calculated as SK\&F-105517-D minus CRV-IR for the PDmin assessment.|||13.15|-16.00|
72592018|NCT00742508|144715045|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.34|STANDARD_ERROR_OF_MEAN|0.133|||TWO_SIDED|95.0|-0.71|0.03|||||The mean treatment difference is calculated as SK\&F-105517-D minus CRV-IR for the PDmax/PDmin assessment.|||0.03|-0.71|
72414530|NCT00321854|144338890|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.4|STANDARD_ERROR_OF_MEAN|0.4||0.0009||95.0|-2.2|-0.6|||ANCOVA|||||-0.6|-2.2|0.0009
72592019|NCT04017832|144715049|SUPERIORITY||Mean Difference (Net)|-0.2||||0.0078|TWO_SIDED|95.0|-0.3|-0.1||Unadjusted two-sided p-value|Mixed model for repeated measurements|||||-0.1|-0.3|0.0078
72592020|NCT04017832|144715049|SUPERIORITY||Mean Difference (Net)|-0.7|||<|0.0001|TWO_SIDED|95.0|-0.8|-0.6||Unadjusted two-sided p-value|Mixed model for repeated measurements|||||-0.6|-0.8|<0.0001
72592021|NCT04017832|144715049|SUPERIORITY||Mean Difference (Net)|-1.0|||<|0.0001|TWO_SIDED|95.0|-1.1|-0.8||Unadjusted two-sided p-value|Mixed model for repeated measurements|||||-0.8|-1.1|< 0.0001
72592022|NCT02100670|144715098|SUPERIORITY_OR_OTHER||Difference of LS mean|-9.23||||0.4144|TWO_SIDED|95.0|-31.45|12.98||P-value from multiple comparisons using t-test in Proc Mixed|ANCOVA|Least squares (LS) means from mixed model analysis of covariance with treatment, site as fixed effects, pain intensity at baseline as a covariates.|Difference of LS mean of first named treatment minus second named treatment. Lower values of LS mean favours a better response because of lower pain intensity over time. 95% Confidence intervals of difference between LS means.|||12.98|-31.45|0.4144
72592023|NCT02100670|144715099|SUPERIORITY_OR_OTHER||LS mean difference|1.58||||0.8761|TWO_SIDED|95.0|-18.34|21.5||P-value from multiple comparisons using t-test in Proc Mixed|ANCOVA|Least squares (LS) means from mixed model analysis of covariance with treatment, site as fixed effects, pain intensity at baseline as a covariates.|Difference of LS mean of first named treatment minus second named treatment. Lower values of LS mean favours a better response because of lower pain intensity over time. 95% Confidence intervals of difference between LS means.|||21.50|-18.34|0.8761
72592024|NCT02100670|144715099|SUPERIORITY_OR_OTHER||LS mean difference|2.61||||0.8164|TWO_SIDED|95.0|-19.46|24.67||P-value from multiple comparisons using t-test in Proc Mixed|ANCOVA|Least squares (LS) means from mixed model analysis of covariance with treatment, site as fixed effects, pain intensity at baseline as a covariates.|Difference of LS mean of first named treatment minus second named treatment. Lower values of LS mean favours a better response because of lower pain intensity over time. 95% Confidence intervals of difference between LS means.|||24.67|-19.46|0.8164
72592025|NCT02100670|144715099|SUPERIORITY_OR_OTHER||LS mean difference|1.03||||0.9279|TWO_SIDED|95.0|-21.27|23.33||P-value from multiple comparisons using t-test in Proc Mixed|ANCOVA|Least squares (LS) means from mixed model analysis of covariance with treatment, site as fixed effects, pain intensity at baseline as a covariates.|Difference of LS mean of first named treatment minus second named treatment. Lower values of LS mean favours a better response because of lower pain intensity over time. 95% Confidence intervals of difference between LS means.|||23.33|-21.27|0.9279
72592026|NCT02100670|144715099|SUPERIORITY_OR_OTHER||LS mean difference|-10.81||||0.3442|TWO_SIDED|95.0|-33.26|11.64||P-value from multiple comparisons using t-test in Proc Mixed.|ANCOVA|Least squares (LS) means from mixed model analysis of covariance with treatment, site as fixed effects, pain intensity at baseline as a covariates.|Difference of LS mean of first named treatment minus second named treatment. Lower values of LS mean favours a better response because of lower pain intensity over time. 95% Confidence intervals of difference between LS means.|||11.64|-33.26|0.3442
72592027|NCT02100670|144715104|SUPERIORITY_OR_OTHER||Cox proportional hazard ratio|1.1||||0.5404|TWO_SIDED|95.0|0.81|1.48||P-value from chi-square test of survival analysis|chi-square test of survival analysis||Cox proportional hazard ratio of survival time, i.e. time to reach perceptible pain relief. The 95% confidence intervals of cox proportional hazard ratio.|||1.48|0.81|0.5404
72592028|NCT02100670|144715104|SUPERIORITY_OR_OTHER||Cox proportional hazard ratio|0.9||||0.4639|TWO_SIDED|95.0|0.67|1.2||P-value from chi-square test of survival analysis.|chi-square test of survival analysis||Cox proportional hazard ratio of survival time, i.e. time to reach perceptible pain relief. The 95% confidence intervals of cox proportional hazard ratio.|||1.20|0.67|0.4639
72592029|NCT02100670|144715104|SUPERIORITY_OR_OTHER||Cox proportional hazard ratio|1.09||||0.5118|TWO_SIDED|95.0|0.84|1.43||P-value from chi-square test of survival analysis.|chi-square test of survival analysis||Cox proportional hazard ratio of survival time, i.e. time to reach perceptible pain relief. The 95% confidence intervals of cox proportional hazard ratio.|||1.43|0.84|0.5118
72592030|NCT02100670|144715105|SUPERIORITY_OR_OTHER||Cox proportional hazard ratio|0.93||||0.6918|TWO_SIDED|95.0|0.67|1.31||P-value from chi-square test of survival analysis.|chi-square test of survival analysis||Cox proportional hazard ratio of survival time, i.e. time to reach perceptible pain relief. The 95% confidence intervals of cox proportional hazard ratio.|||1.31|0.67|0.6918
72592031|NCT02100670|144715105|SUPERIORITY_OR_OTHER||Cox proportional hazard ratio|1.23||||0.2389|TWO_SIDED|95.0|0.87|1.73||P-value from chi-square test of survival analysis.|chi-square test of survival analysis||Cox proportional hazard ratio of survival time, i.e. time to reach perceptible pain relief. The 95% confidence intervals of cox proportional hazard ratio.|||1.73|0.87|0.2389
72592032|NCT02100670|144715105|SUPERIORITY_OR_OTHER||Cox proportional hazard ratio|1.0||||0.9817|TWO_SIDED|95.0|0.74|1.37||P-value from chi-square test of survival analysis.|chi-square test of survival analysis||Cox proportional hazard ratio of survival time, i.e. time to reach perceptible pain relief. The 95% confidence intervals of cox proportional hazard ratio.|||1.37|0.74|0.9817
72414531|NCT00321854|144338891|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.4|STANDARD_ERROR_OF_MEAN|0.4||0.0005||95.0|-2.1|-0.6|||ANCOVA|||||-0.6|-2.1|0.0005
72592033|NCT02100670|144715106|SUPERIORITY_OR_OTHER||Cox proportional hazard ratio|1.06||||0.7003|TWO_SIDED|95.0|0.79|1.43||P-value from chi-square test of survival analysis|chi-square test of survival analysis||Cox proportional hazard ratio of survival time, i.e. time to cooling sensation. The 95% confidence intervals of cox proportional hazard ratio.|||1.43|0.79|0.7003
72414532|NCT00321854|144338892|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.7|STANDARD_ERROR_OF_MEAN|0.3||0.0422||95.0|-1.4|0.0|||ANCOVA|||||0|-1.4|0.0422
72414533|NCT00321854|144338893|SUPERIORITY_OR_OTHER||Median Difference (Net)|-0.573||||0.2149||95.0|-1.823|0.677|||Wilcoxon (Mann-Whitney)|||||0.677|-1.823|0.2149
72414534|NCT00321854|144338894|SUPERIORITY_OR_OTHER||Median Difference (Net)|-2.031||||0.0001||95.0|-3.125|-0.938|||Wilcoxon (Mann-Whitney)|||||-0.938|-3.125|0.0001
72414535|NCT00321854|144338895|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.0||||0.2605||95.0|0.0|0.026|||Wilcoxon (Mann-Whitney)|||||0.026|0|0.2605
72414536|NCT00321854|144338896|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.051|||<|0.0001||95.0|0.0|0.089|||Wilcoxon (Mann-Whitney)|||||0.089|0|<0.0001
72592034|NCT02100670|144715106|SUPERIORITY_OR_OTHER||Cox proportional hazard ratio|1.01||||0.9565|TWO_SIDED|95.0|0.75|1.35||P-value from chi-square test of survival analysis.|chi-square test of survival analysis||Cox proportional hazard ratio of survival time, i.e. time to cooling sensation. The 95% confidence intervals of cox proportional hazard ratio.|||1.35|0.75|0.9565
72592035|NCT02100670|144715106|SUPERIORITY_OR_OTHER||Cox proportional hazard ratio|1.07||||0.6216|TWO_SIDED|95.0|0.82|1.4||P-value from chi-square test of survival analysis.|chi-square test of survival analysis||Cox proportional hazard ratio of survival time, i.e. time to cooling sensation. The 95% confidence intervals of cox proportional hazard ratio.|||1.40|0.82|0.6216
72592036|NCT02100670|144715110|SUPERIORITY_OR_OTHER||Cox proportional hazard ratio|2.43||||0.0408|TWO_SIDED|95.0|1.04|5.7||P-value from chi-square test of survival analysis.|chi-square test of survival analysis||Cox proportional hazard ratio of survival time, i.e. time to complete pain relief. The 95% confidence intervals of cox proportional hazard ratio.|||5.70|1.04|0.0408
72592037|NCT02100670|144715110|SUPERIORITY_OR_OTHER||Cox proportional hazard ratio|1.31||||0.4507|TWO_SIDED|95.0|0.65|2.65||P-value from chi-square test of survival analysis.|chi-square test of survival analysis||Cox proportional hazard ratio of survival time, i.e. time to complete pain relief. The 95% confidence intervals of cox proportional hazard ratio.|||2.65|0.65|0.4507
72592038|NCT02100670|144715110|SUPERIORITY_OR_OTHER||Cox proportional hazard ratio|1.38||||0.315|TWO_SIDED|95.0|0.73|2.61||P-value from chi-square test of survival analysis.|chi-square test of survival analysis||Cox proportional hazard ratio of survival time, i.e. time to complete pain relief. The 95% confidence intervals of cox proportional hazard ratio.|||2.61|0.73|0.3150
72592039|NCT03634033|144715112|SUPERIORITY|Examination of intensity of facilitation (IF vs IF+EF) on adoption and sustainability using an evidence-based intervention (CAPABLE).|Mean Difference (Final Values)|10.89|STANDARD_DEVIATION|18.17||0.22|TWO_SIDED|95.0|-7.27|29.05||A priori threshold for statistical significance was .05|t-test, 2 sided|16 degrees of freedom for the t-test comparing two independent groups, n=9 each.||Given 18 sites (9 in each arm) available in Michigan, in the comparison of site-level outcome of adoption and sustainability, the detectable effect size with power of 0.80 in two-sided tests at .05 level of significance was d=1.41.||29.05|-7.27|0.22
72592040|NCT03634033|144715113|SUPERIORITY|Examination of intensity of facilitation (IF vs IF+EF) on beneficiaries ADLs at exit using an evidence-based intervention (CAPABLE).|Mean Difference (Final Values)|0.28|STANDARD_ERROR_OF_MEAN|0.23||0.73|TWO_SIDED|95.0|-0.16|0.73||A priori threshold for statistical significance was .05; no adjustments for multiple comparisons|Mixed Models Analysis|F-test was used built into mixed models that adjusted for clustering via a random effect of site.|IF minus IF+EF|Adjusted means at month 9 were calculated adjusting for baseline value of the outcome and nesting of participants within sites.||0.73|-0.16|0.73
72592041|NCT03634033|144715114|SUPERIORITY|Examination of intensity of facilitation (IF vs IF+EF) needed on beneficiaries IADLs using an evidence-based intervention (CAPABLE).|Mean Difference (Final Values)|0.3|STANDARD_ERROR_OF_MEAN|0.21||0.15|TWO_SIDED|95.0|-0.11|0.72||Threshold for statistical significance was .05 with no adjustments for multiple comparisons.|Mixed Models Analysis|F-test was used built into mixed models that adjusted for clustering.|IF minus IF+EF|Post-intervention means were compared adjusting for baseline values and nesting of participants within sites.||0.72|-0.11|0.15
72592042|NCT03634033|144715115|SUPERIORITY|Examination of intensity of facilitation (IF vs IF+EF) needed on beneficiaries pain at exit using an evidence-based intervention (CAPABLE).|Mean Difference (Final Values)|0.08|STANDARD_ERROR_OF_MEAN|0.16||0.61|TWO_SIDED|95.0|-0.23|0.39||Threshold for statistical significance was.05; no adjustments for multiple comparisons|Mixed Models Analysis|F-test was used built into mixed models that adjusted for clustering.|IF minus IF+EF|||0.39|-0.23|0.61
72592043|NCT03634033|144715116|SUPERIORITY|Examination of intensity of facilitation (IF vs IF+EF) needed on beneficiaries depression (baseline to exit) using an evidence-based intervention (CAPABLE).|LS Means|0.05|STANDARD_ERROR_OF_MEAN|0.05||0.04|TWO_SIDED|95.0|0.01|0.24|||F-test|F-test was used (related to the t-test arithmetically), built into mixed models that adjusted for clustering.||||0.24|0.01|0.04
72592044|NCT03634033|144715117|SUPERIORITY|Examination of intensity of facilitation (IF vs IF+EF) on beneficiaries fall rates at exit after an evidence-based intervention (CAPABLE).|Odds Ratio (OR)|1.16|STANDARD_ERROR_OF_MEAN|0.01||0.18|TWO_SIDED|95.0|0.93|1.45|||Mixed Models Analysis|||||1.45|0.93|0.18
72592045|NCT03634033|144715117|SUPERIORITY||Odds Ratio (OR)|1.16||||0.18|TWO_SIDED|95.0|0.93|1.45||Threshold for statistical significance was .05; no adjustment for multiple comparisons.|Mixed Models Analysis||Odds ratio for IF versus IF+EF|Occurrence of falls was analyzed with adjustment for baseline and nesting of participants within sites.||1.45|0.93|.18
72592046|NCT03634033|144715118|SUPERIORITY|Examination of intensity of facilitation (IF vs IF+EF) on beneficiaries ED Visits at exit after an evidence-based intervention (CAPABLE).|Odds Ratio (OR)|0.98|STANDARD_ERROR_OF_MEAN|0.01||0.86|TWO_SIDED|95.0|0.79|1.22||Threshold for statistical significance was .05 with no adjustments for multiple comparisons.|Mixed Models Analysis|Adjustment for baseline and nesting of participants within sites.||||1.22|0.79|0.86
72592047|NCT03634033|144715119|SUPERIORITY|Examination of intensity of facilitation (IF vs IF+EF) needed on beneficiaries hospitalizations (baseline to exit) using an evidence-based intervention (CAPABLE).|Odds Ratio (OR)|1.01|STANDARD_ERROR_OF_MEAN|1.01||0.95|TWO_SIDED|95.0|0.72|1.42|||F-test|F-test was used (related to the t-test arithmetically), built into mixed models that adjusted for clustering.||||1.42|0.72|0.95
72592048|NCT03634033|144715120|SUPERIORITY|Examination of clinician attitude on facilitation (IF vs IF+EF) at exit when using an evidence-based intervention (CAPABLE).|Mean Difference (Final Values)|5.11|STANDARD_ERROR_OF_MEAN|2.55||0.05|TWO_SIDED|95.0|0.09|10.14|||Mixed Models Analysis|||Mixed modeling was used to account for nesting of clinicians within sites.||10.14|0.09|0.05
72414537|NCT00321854|144338897|SUPERIORITY_OR_OTHER||Median Difference (Net)|2.0||||0.0489||95.0|0.0|5.0|||Wilcoxon (Mann-Whitney)|||||5|0|0.0489
72414538|NCT00321854|144338898|SUPERIORITY_OR_OTHER||Median Difference (Net)|3.0||||0.0282||95.0|0.0|5.0|||Wilcoxon (Mann-Whitney)|||||5|0|0.0282
72592049|NCT03634033|144715121|OTHER|Examination of clinician self-efficacy on facilitation (IF vs IF+EF) (baseline to exit) when using an evidence-based intervention (CAPABLE).|Mean Difference (Final Values)|0.23|STANDARD_ERROR_OF_MEAN|0.36||0.54|TWO_SIDED|95.0|-0.51|0.97||Threshold for statistical significance was .05 with no adjustments for multiple testing.|Mixed Models Analysis|Nesting of clinicians within site was adjusted for as a random effect.||||0.97|-0.51|0.54
72592050|NCT03634033|144715124|SUPERIORITY|Pre-/post-intervention comparison.|Mean Difference (Net)|-2.69|STANDARD_ERROR_OF_MEAN|1.63|<|0.01|TWO_SIDED|95.0|-3.96|-1.42|||t-test, 2 sided||Pre minus post|Pain||-1.42|-3.96|<.01
72592051|NCT03634033|144715124|SUPERIORITY||Mean Difference (Net)|1.05|STANDARD_ERROR_OF_MEAN|1.9||0.58|TWO_SIDED|95.0|-2.8|4.91||Threshold for statistical significance was .05 with no adjustments for multiple comparisons.|t-test, 2 sided|||ADL||4.91|-2.80|.58
72592052|NCT03634033|144715124|SUPERIORITY||Mean Difference (Net)|1.05|STANDARD_ERROR_OF_MEAN|1.29||0.44|TWO_SIDED|95.0|-2.8|4.91||Threshold for statistical significance was .05 with no adjustments for multiple comparisons.|t-test, 2 sided|||IADL||4.91|-2.80|.44
72414539|NCT00321854|144338914|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.5|STANDARD_ERROR_OF_MEAN|2.5||0.8397||95.0|-5.4|4.4|||ANCOVA|||||4.4|-5.4|0.8397
72592053|NCT03634033|144715124|SUPERIORITY||Mean Difference (Net)|1.46|STANDARD_ERROR_OF_MEAN|1.63||0.38|TWO_SIDED|95.0|-1.85|4.77||Threshold for statistical significance was .05 with no adjustments for multiple comparisons.|t-test, 2 sided||Pre minus post|Depression||4.77|-1.85|.38
72592054|NCT03634033|144715125|SUPERIORITY|Self-efficacy|Mean Difference (Net)|-0.81|STANDARD_DEVIATION|0.11|<|0.01|TWO_SIDED|95.0|-1.02|-0.6||Threshold for statistical significance was .05 with no adjustments for multiple comparisons.|t-test, 2 sided||Pre minus post|Self-efficacy change baseline (month-0) to exit (month-4).||-0.60|-1.02|<0.01
72592055|NCT03634033|144715126|OTHER|Score on scale.|Mean|8.09|STANDARD_DEVIATION|1.6|<|0.01|TWO_SIDED||||||t-test, 2 sided|||||||<.01
72592056|NCT03634033|144715126|OTHER||Mean|7.55|STANDARD_DEVIATION|2.06|<|0.01|TWO_SIDED||||||t-test, 2 sided|||Satisfaction with format||||<.01
72592057|NCT03634033|144715126|OTHER||Mean|8.35|STANDARD_DEVIATION|1.5|<|0.01|TWO_SIDED||||||Difference from zero|||Satisfaction with newness of content for caregiver||||<.01
72592058|NCT03634033|144715126|OTHER||Mean|7.85|STANDARD_DEVIATION|1.92|<|0.01|TWO_SIDED||||||Difference from zero|||Satisfaction with newness of content for clinician||||<.01
72592059|NCT03634033|144715126|OTHER||Mean|7.85|STANDARD_DEVIATION|1.92|<|0.01|TWO_SIDED||||||Difference from zero|||Intent to use new information||||<.01
72592060|NCT04338269|144715135|OTHER|Stratified Cox Proportional Hazards Model|Hazard Ratio (HR)|1.03||||0.7844|TWO_SIDED|95.0|0.83|1.28|||Log Rank|Stratified|Hazard ratios were estimated by Cox regression. If at least one stratum has \<10 events at the time of analysis, the stratification factor that contains the level with the smallest number of patients will be removed from the stratified analysis.|||1.28|0.83|0.7844
72592061|NCT04338269|144715135|OTHER||Hazard Ratio (HR)|1.04||||0.7195|TWO_SIDED|95.0|0.84|1.29|||Log Rank|Unstratified|Hazard ratios were estimated by Cox regression.|Cox Proportional Hazards Model||1.29|0.84|0.7195
72592062|NCT04338269|144715136|OTHER|Stratified Cox Proportional Hazards Model|Hazard Ratio (HR)|0.94||||0.6902|TWO_SIDED|95.0|0.7|1.27|||Log Rank|Stratified|Hazard ratios were estimated by Cox regression. If at least one stratum has \<10 events at the time of analysis, the stratification factor that contains the level with the smallest number of patients will be removed from the stratified analysis.|||1.27|0.70|0.6902
72592063|NCT04338269|144715136|OTHER|Cox Proportional Hazards Model|Hazard Ratio (HR)|0.96||||0.7853||95.0|0.71|1.27|||Log Rank|Unstratified|Hazard ratios were estimated by Cox regression.|||1.27|0.71|0.7853
72592064|NCT04338269|144715137|OTHER|Stratified Cox Proportional Hazards Model|Hazard Ratio (HR)|1.03||||0.8037|TWO_SIDED|95.0|0.83|1.27|||Log Rank|Stratified|Hazard ratios were estimated by Cox regression. If at least one stratum has \<10 events at the time of analysis, the stratification factor that contains the level with the smallest number of patients will be removed from the stratified analysis.|||1.27|0.83|0.8037
72592065|NCT04338269|144715137|OTHER|Cox Proportional Hazards Model|Hazard Ratio (HR)|1.03||||0.7894|TWO_SIDED|95.0|0.83|1.27|||Log Rank|Unstratified|Hazard ratios were estimated by Cox regression.|||1.27|0.83|0.7894
72414540|NCT01981564|144338986|SUPERIORITY|||||||0.06|||||||ANOVA|||ANOVA F=3.55, df=1, p=0.06||||0.06
72592066|NCT04338269|144715138|OTHER|Difference in Overall Response Rates|Odds Ratio (OR)|-3.68||||0.4306|TWO_SIDED|95.0|-12.45|5.1|||Cochran-Mantel-Haenszel||Odds ratio 95% CI was constructed using the Wald method. If at least one stratum has \<10 events at the time of analysis, the stratification factor containing the level with the smallest number of patients will be removed from the stratified analysis|||5.10|-12.45|0.4306
72592067|NCT04338269|144715139|OTHER|Difference in Overall Response Rates|Odds Ratio (OR)|1.0||||0.9893|TWO_SIDED|95.0|0.7|1.43|||Cochran-Mantel-Haenszel||Odds ratio 95% CI was constructed using the Wald method. If at least one stratum has \<10 events at the time of analysis, the stratification factor containing the level with the smallest number of patients will be removed from the stratified analysis|||1.43|0.70|0.9893
72592068|NCT04338269|144715140|OTHER|Difference between Duration of Response (DOR) rates|Hazard Ratio (HR)|0.7||||0.0816|TWO_SIDED|95.0|0.47|1.05|||Log Rank|Stratified|Hazard ratios were estimated by Cox regression. If at least one stratum has \<10 events at the time of analysis, the stratification factor that contains the level with the smallest number of patients will be removed from the stratified analysis.|||1.05|0.47|0.0816
72592069|NCT04338269|144715140|OTHER|Difference between Duration of Response (DOR) rates|Hazard Ratio (HR)|0.72||||0.1099||95.0|0.49|1.08|||Log Rank|Unstratified|Hazard ratios were estimated by Cox regression. If at least one stratum has \<10 events at the time of analysis, the stratification factor that contains the level with the smallest number of patients will be removed from the stratified analysis.|||1.08|0.49|0.1099
72592070|NCT04338269|144715141|OTHER|Difference between Duration of Response (DOR) rates|Hazard Ratio (HR)|1.04||||0.8354|TWO_SIDED|95.0|0.7|1.54|||Log Rank|Stratified|Hazard ratios were estimated by Cox regression. If at least one stratum has \<10 events at the time of analysis, the stratification factor that contains the level with the smallest number of patients will be removed from the stratified analysis.|||1.54|0.70|0.8354
72592071|NCT04338269|144715141|OTHER|Difference between Duration of Response (DOR) rates|Hazard Ratio (HR)|1.05||||0.8159|TWO_SIDED|95.0|0.71|1.55|||Log Rank|Unstratified|Hazard ratios were estimated by Cox regression. If at least one stratum has \<10 events at the time of analysis, the stratification factor that contains the level with the smallest number of patients will be removed from the stratified analysis.|||1.55|0.71|0.8159
72592072|NCT02715700|144715142|OTHER|Geometric mean ratio (GMR) of Methadone + Doravirine/Methadone Alone|GMR|0.95|||||TWO_SIDED|90.0|0.9|1.01||||||||1.01|0.90|
72592073|NCT02715700|144715143|OTHER|GMR of Methadone + Doravirine/Methadone Alone|GMR|0.95|||||TWO_SIDED|90.0|0.88|1.03||||||||1.03|0.88|
72592074|NCT02715700|144715144|OTHER|GMR of Methadone + Doravirine/Methadone Alone|GMR|0.98|||||TWO_SIDED|90.0|0.93|1.03||||||||1.03|0.93|
72414541|NCT01201629|144339057|OTHER||||||<|0.05|||||||t-test, 2 sided|||||||< 0.05
72592075|NCT02715700|144715146|OTHER|Geometric mean ratio (GMR) of Methadone + Doravirine/Methadone Alone|GMR|0.98|||||TWO_SIDED|90.0|0.9|1.06||||||||1.06|0.90|
72592076|NCT02715700|144715147|OTHER|GMR of Methadone + Doravirine/Methadone Alone|GMR|0.97|||||TWO_SIDED|90.0|0.86|1.1||||||||1.10|0.86|
72592077|NCT02715700|144715148|OTHER|GMR of Methadone + Doravirine/Methadone Alone|GMR|0.97|||||TWO_SIDED|90.0|0.91|1.04||||||||1.04|0.91|
72592078|NCT02715700|144715150|OTHER|Geometric mean ratio (GMR) of Methadone + Doravirine/Methadone Alone|GMR|0.96|||||TWO_SIDED|90.0|0.9|1.03||||||||1.03|0.90|
72414542|NCT01201629|144339058|OTHER||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
72414543|NCT03858803|144339076|SUPERIORITY||||||<|0.05|||||||MANOVA|||||||<.05
72414544|NCT03858803|144339077|SUPERIORITY||||||<|0.05|||||||MANOVA|||||||<.05
72414545|NCT03858803|144339078|SUPERIORITY||||||<|0.05|||||||MANOVA|||||||<.05
72414546|NCT03858803|144339079|SUPERIORITY||||||<|0.05|||||||MANOVA|||||||<.05
72414547|NCT03858803|144339080|SUPERIORITY||||||<|0.05|||||||MANOVA|||||||<.05
72414548|NCT03858803|144339081|SUPERIORITY||||||<|0.05|||||||MANOVA|||||||<.05
72592079|NCT02715700|144715151|OTHER|GMR of Methadone + Doravirine/Methadone Alone|GMR|0.96|||||TWO_SIDED|90.0|0.87|1.05||||||||1.05|0.87|
72592080|NCT02715700|144715152|OTHER|GMR of Methadone + Doravirine/Methadone Alone|GMR|0.98|||||TWO_SIDED|90.0|0.92|1.03||||||||1.03|0.92|
72592081|NCT02730377|144715154|SUPERIORITY||||||<|0.0001|||||||Log Rank|||Test for no treatment difference is based on using a generalised log-rank test for interval censored failure time data.||||<.0001
72592082|NCT03796442|144715180|NON_INFERIORITY|The study was designed to have 80% power to detect 1-year AVMPG of 12.6±4.3mmHg for the study prosthesis and 11.9±4.3mmHg for the control prosthesis, with a 1-sided type I error of 2.5% and a noninferiority margin of 3mmHg. The noninferiority margin was determined by the values of 15mmHg for AVMPG of clinically significant aortic stenosis and 12mmHg for AVMPG of the control prosthesis.||||||0.0004|||||||t-test, 1 sided|||The null hypothesis was that the AvalusTM was inferior to the CEPME based on the AVMPG at 1-year echocardiographic follow-up, with a non-inferiority margin of 3mmHg. The result for the primary endpoint was presented with 97.5% one-sided confidence interval for mean difference between groups. The non-inferiority test was performed using a t-test which compared mean difference between groups with the non-inferiority margin under the one-sided significance level of 0.025.||||0.0004
72592083|NCT02729038|144715217|OTHER||Ratio of geometric LS means|1.507|||||TWO_SIDED|90.0|0.902|2.519|||||AUC (0-inf) for participants with normal renal function Vs participants with moderate renal function has been presented.|||2.519|0.902|
72592084|NCT02729038|144715217|OTHER||Ratio of geometric LS means|1.924|||||TWO_SIDED|90.0|1.151|3.215|||||AUC (0-inf) for participants with normal renal function Vs participants with Severe/ESRD not on hemodialysis|||3.215|1.151|
72592085|NCT02729038|144715218|OTHER||Ratio of geometric LS means|2.375|||||TWO_SIDED|90.0|1.421|3.969|||||AUC (0-inf) for participants with normal renal function Vs ESRD on hemodialysis (before hemodialysis)|||3.969|1.421|
72414549|NCT03858803|144339082|SUPERIORITY||||||<|0.05|||||||MANOVA|||||||<.05
72414550|NCT03858803|144339083|SUPERIORITY||||||<|0.05|||||||MANOVA|||||||<.05
72414551|NCT03858803|144339084|SUPERIORITY||||||<|0.05|||||||MANOVA|||||||<.05
72414552|NCT03858803|144339085|SUPERIORITY||||||<|0.05|||||||MANOVA|||||||<.05
72414553|NCT03858803|144339086|SUPERIORITY||||||<|0.05|||||||MANOVA|||||||<.05
72414554|NCT01358526|144339093|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.45|STANDARD_ERROR_OF_MEAN|0.163||0.0055|TWO_SIDED|95.0|0.13|0.77||A gate-keeping strategy and a Bonferroni-Holm method was used to control the family-wise (primary and secondary efficacy analysis) error rate at the 5% level.|Mixed Models Analysis|Mixed-model repeated measures analysis of pain data using a pattern mixture model framework||||0.77|0.13|0.0055
72414555|NCT01358526|144339094|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.3|STANDARD_ERROR_OF_MEAN|2.26||0.0191|TWO_SIDED|95.0|0.9|9.8|||Mixed Models Analysis|Mixed-model repeated measures analysis|Mean difference (final values) is the treatment comparison estimated using mixed model repeated measures analysis with effect for treatment, time (weeks 4, 8, 12), treatment by time interaction, and prerandomization value. Subject is a random effect.|||9.8|0.9|0.0191
72414556|NCT01358526|144339095|SUPERIORITY_OR_OTHER|||||||0.0002||||||"The proportion of subjects responding much improved and very much improved was summarized by treatment group and compared between groups using an exact test"|Fisher Exact|||||||0.0002
72592086|NCT02729038|144715218|OTHER||Ratio of geometric LS means|4.075|||||TWO_SIDED|90.0|2.438|6.81|||||AUC (0-inf) for participants with normal renal function Vs ESRD on hemodialysis (after hemodialysis)|||6.810|2.438|
72592087|NCT02729038|144715219|OTHER||Ratio of geometric LS means|1.179|||||TWO_SIDED|90.0|0.467|2.977|||||Cmax for participants with normal renal function Vs participants with moderate renal function has been presented.|||2.977|0.467|
72592088|NCT02729038|144715219|OTHER||Ratio of geometric LS means|1.575|||||TWO_SIDED|90.0|0.624|3.975|||||Cmax for participants with normal renal function Vs .participants with Severe/ESRD not on hemodialysis|||3.975|0.624|
72592089|NCT02729038|144715220|OTHER||Ratio of geometric LS means|2.25|||||TWO_SIDED|90.0|0.891|5.681|||||Cmax for participants with normal renal function Vs ESRD on hemodialysis (before hemodialysis)|||5.681|0.891|
72592090|NCT02729038|144715220|OTHER||Ratio of geometric LS means|5.966|||||TWO_SIDED|90.0|2.363|15.062|||||Cmax for participants with normal renal function Vs ESRD on hemodialysis (after hemodialysis)|||15.062|2.363|
72592091|NCT02729038|144715242|OTHER||Ratio of geometric LS means|1.501|||||TWO_SIDED|90.0|0.894|2.52|||||Normal Vs Moderate|||2.520|0.894|
72592092|NCT02729038|144715242|OTHER||Ratio of geometric LS means|1.912|||||TWO_SIDED|90.0|1.139|3.212|||||Normal Vs Severe/ESRD not on hemodialysis|||3.212|1.139|
72592093|NCT02729038|144715243|OTHER||Ratio of geometric LS means|2.375|||||TWO_SIDED|90.0|1.414|3.989|||||Normal Vs ESRD on hemodialysis (before hemodialysis)|||3.989|1.414|
72592094|NCT02729038|144715243|OTHER||Ratio of geometric LS means|4.068|||||TWO_SIDED|90.0|2.422|6.831|||||Normal Vs ESRD on hemodialysis (after hemodialysis)|||6.831|2.422|
72592095|NCT00308087|144715278|SUPERIORITY_OR_OTHER|||||||0.6182||95.0||||"Exact Conditional Test is stratified on the number~\> of prior therapies (1 or 2, 3 or more prior therapies)."|2-sided Exact Conditional Test|||||||0.6182
72592096|NCT00308087|144715281|SUPERIORITY_OR_OTHER|||||||0.5501||95.0|||||Log Rank|||Log rank analysis is a comparison between treatment groups of the distribution of time to first progressive disease or death.||||0.5501
72592097|NCT00308087|144715282|SUPERIORITY_OR_OTHER|||||||0.8217||95.0|||||Log Rank|||Log rank analysis is a comparison between treatment groups of the distribution of time to first progressive disease or death.||||0.8217
72592098|NCT05007041|144715321|NON_INFERIORITY|The one-sided non-inferiority test with the alpha level set at 0.025 and non-inferiority margin of 10%, stratified by site.|Difference in proportions|-0.96||||0.0037|TWO_SIDED|95.0|-8.94|7.1|||Difference in proportions|The upper bound of a site-stratified Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting of the difference was used.||The null hypothesis is simultaneous vaccination with RZV and allV4 is inferior (i.e., RZV and allV4 will have a higher proportion) to RZV and HD-IIV4 with regard to the proportion of adults with at least one severe (Grade 3) solicited local or systemic reactogenicity event on days 1-8 after RZV dose||7.10|-8.94|0.0037
72592099|NCT05007041|144715322|OTHER|Difference in proportions|Difference in proportions|-7.77|||||TWO_SIDED|95.0|-20.22|4.69||||||||4.69|-20.22|
72592100|NCT05007041|144715323|OTHER|Difference in proportions|Difference in proportions|2.59|||||TWO_SIDED|95.0|-7.29|12.47||||||||12.47|-7.29|
72592101|NCT05007041|144715324|NON_INFERIORITY|The one-sided non-inferiority test with the alpha level set at 0.025 and non-inferiority margin of 10%, stratified by site.|Difference in proportions|1.74||||0.0031|TWO_SIDED|95.0|-4.04|7.77||The upper bound of a site-stratified Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting of the difference was used.|Difference in proportions|||Number of Participants With at Least One Severe (Grade 3) Solicited Local Reactogenicity Event After SHINGRIX® Dose 1 in Each Study Group||7.77|-4.04|0.0031
72592102|NCT05007041|144715325|OTHER|Difference in proportions|Difference in proportions|-6.25|||||TWO_SIDED|95.0|-13.1|0.6|||Difference in proportions|||||0.60|-13.10|
72592103|NCT05007041|144715326|OTHER|Difference in proportions|Difference in proportions|5.89|||||TWO_SIDED|95.0|-1.32|13.11|||Difference in proportions|||||13.11|-1.32|
72592104|NCT05007041|144715327|NON_INFERIORITY|The one-sided non-inferiority test with the alpha level set at 0.025 and non-inferiority margin of 10%, stratified by site.|Difference in proportions|-4.17|||<|0.0001|TWO_SIDED|95.0|-10.9|2.47|||Difference in proportions|The upper bound of a site-stratified Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting of the difference was used.||||2.47|-10.90|<0.0001
72592105|NCT05007041|144715328|OTHER|Difference in proportions|Difference in proportions|-5.68|||||TWO_SIDED|95.0|-17.64|6.28|||Difference in proportions|||||6.28|-17.64|
72592106|NCT05007041|144715329|OTHER|Difference in proportions|Difference in proportions|-3.3|||||TWO_SIDED|95.0|-10.5|3.89|||Difference in proportions|||||3.89|-10.50|
72592107|NCT05007041|144715330|OTHER|Difference in proportions|Difference in proportions|-0.73|||||TWO_SIDED|95.0|-2.16|0.7|||Difference in proportions|||||0.70|-2.16|
72592108|NCT05007041|144715331|OTHER|The proportion and 95% exact binomial confidence interval between vaccine groups.|Difference in proportions|-2.88|||||TWO_SIDED|95.0|-6.36|0.6|||Difference in proportions|||||0.60|-6.36|
72592109|NCT00715728|144715394|EQUIVALENCE|Our primary outcome was the rate of core rewarming during the surgery. Groups were compared on mean rewarming rate in a linear mixed effects regression model with within-subject change of core temperature over time as random effect. Using those model results, equivalence on the mean rate of rewarming for the resistive and warm air systems was assessed with the 2 one-tailed tests equivalence testing approach and equivalence delta of 0.2 degrees C/hours.||||||0.91||||||Two 1-tailed tests were conducted. P-value for lower delta was 0.91. Equivalence will be claimed if p-values for upper and lower delta are both lower than 0.05 ⁄ 2 = 0.025.|t-test, 1 sided|"Two 1-tailed tests were conducted to assess equivalence. See  Type of Statistical Test."||A total of 46 patients (23 per group) were needed to have 90% power to demonstrate equivalence of the two warming methods on final intra-operative temperature at the 0.05 significance level using the 2 one-tailed tests equivalence testing technique and an equivalence region of 0.5 degrees C per hour, assuming a SD of 0.5 degrees C/hour for each group and zero true difference.||||0.91
72592110|NCT00715728|144715394|EQUIVALENCE|Our primary outcome was the rate of core rewarming during the surgery. Groups were compared on mean rewarming rate in a linear mixed effects regression model with within-subject change of core temperature over time as random effect. Using those model results, equivalence on the mean rate of rewarming for the resistive and warm air systems was assessed with the 2 one-tailed tests equivalence testing approach and equivalence delta of 0.2 degrees C/hours.|||||<|0.001||||||Two 1-tailed tests were conducted. P-value for lower delta was 0.91. Equivalence will be claimed if p-values for upper and lower delta are both lower than 0.05 ⁄ 2 = 0.025.|t-test, 1 sided|||A total of 46 patients (23 per group) were needed to have 90% power to demonstrate equivalence of the two warming methods on final intra-operative temperature at the 0.05 significance level using the 2 one-tailed tests equivalence testing technique and an equivalence region of 0.5 degrees C per hour, assuming a SD of 0.5 degrees C/hour for each group and zero true difference.||||<0.001
72592111|NCT00715728|144715395|NON_INFERIORITY|The non-inferiority margin is defined as 0.5 °C. Non-inferiority at the 0.025 significance level will be claimed if the lower limit of the 95% confidence interval is higher than the -0.5 °C.|Mean Difference (Final Values)|-0.12||||0.018|TWO_SIDED|95.0|-0.37|0.14||P-value was adjusted for preoperative oral temperature and ASA physical status.|t-test, 1 sided||Non-inferiority will be established, at the 0.025 significance level, if the lower limit of a 95% confidence interval for the difference is above -0.5 °C.|Null hypothesis is the Hot dog resistive heating system is inferior to the Bair Hugger forced air system. Mean difference (95% CI) of the intraoperative TWA temperature between the groups (resistive heating versus forced-air) will be adjusting for preoperative oral temperature and ASA physical status.||0.14|-0.37|0.018
72592112|NCT01500213|144715396|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.4||||0.043|TWO_SIDED|95.0|1.0|2.1||To control for multiplicity, analyses were performed hierarchically. For the CR delayed the threshold for statistical significance was 0.05; no further adjustment for multiplicity were required for the primary endpoint.|Cochran-Mantel-Haenszel|Cochran Mantel Haenszel (CMH) test was stratified by sex. Missing data were imputed as treatment failures.||||2.1|1.0|0.043
72592113|NCT01500213|144715397|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.3||||0.233|TWO_SIDED|95.0|0.8|2.0||To control for multiplicity, analyses were performed hierarchically. CR-acute was tested only if the result for the primary endpoint, CR delayed, was statistically significant.|Cochran-Mantel-Haenszel|Cochran Mantel Haenszel (CMH) test was stratified by sex. Missing data were imputed as treatment failures.||||2.0|0.8|0.233
72592114|NCT01500213|144715398|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.4||||0.084|TWO_SIDED|95.0|1.0|1.9||To control for multiplicity, analyses were performed hierarchically. CR overall was tested only if both CR delayed and CR acute were statistically significant.|Cochran-Mantel-Haenszel|Cochran Mantel Haenszel (CMH) test was stratified by sex. Missing data were imputed as treatment failures.||||1.9|1.0|0.084
72592115|NCT03197870|144715401|SUPERIORITY|The primary hypotheses was tested in the modified intent-to-treat population using a Fisher's Exact Test with a 2-sided 5% significance level. razuprotafib 15 mg twice daily was tested first. If this was found to be statistically significant, then razuprotafib 15 mg once daily will be tested for statistical significance, at the same significance level.||||||0.495||||||Missing data was imputed using last observation carried forward; baseline values were not carried forward.|Fisher Exact|||The primary hypotheses tested was that razuprotafib 15 mg twice daily and razuprotafib 15 mg once daily will be superior to placebo in the improvement of diabetic retinopathy as measured by the Early Treatment Diabetic Retinopathy Study severity scale change from baseline at 48 weeks.||||0.495
72592116|NCT01542034|144715414|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|3.702|||<|0.001|TWO_SIDED|95.0|2.808|4.88|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) method stratified by pooled study center.|A risk ratio greater than 1 favors deoxycholic acid injection treatment, and between 0 and 1 favors placebo.|The primary analysis was satisfied if both null hypotheses (there is no treatment difference in 1-grade or 2-grade response rate) were rejected in favor of the two-tailed alternative at the 0.05 level of significance for both primary efficacy endpoints, and the response rates were higher for the deoxycholic acid injection treatment group than the placebo group. Because both hypotheses must be rejected, the type I error was preserved when testing the primary endpoints.||4.880|2.808|<0.001
72592117|NCT01542034|144715415|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|CMH method stratified by pooled study center.||The primary analysis was satisfied if both null hypotheses (there is no treatment difference in 1-grade or 2-grade response rate) were rejected in favor of the two-tailed alternative at the 0.05 level of significance for both primary efficacy endpoints, and the response rates were higher for the deoxycholic acid injection treatment group than the placebo group. Because both hypotheses must be rejected, the type I error was preserved when testing the primary endpoints.||||<0.001
72592118|NCT01542034|144715416|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|8.541|||<|0.001|TWO_SIDED|95.0|3.62|20.148|||Cochran-Mantel-Haenszel|CMH method stratified by pooled study center|A risk ratio greater than 1 favors deoxycholic acid injection treatment, and between 0 and 1 favors placebo.|If both primary endpoints were statistically significant, testing continued to the 2 secondary endpoints using the Bonferroni-Holm method. The smaller of the 2 p-values for the treatment difference was tested at the 0.025 level. If significant, testing proceeded for the remaining secondary endpoint at the 0.05 level. If the smaller p-value was \> 0.025, the null hypothesis for the associated variable would not be rejected, and testing of the second endpoint would not proceed.||20.148|3.620|<0.001
72592119|NCT01542034|144715417|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|Analysis of covariance (ANCOVA) model included treatment and Baseline PR-SMFIS total scale score.||If both primary endpoints were statistically significant, testing continued to the 2 secondary endpoints using the Bonferroni-Holm method. The smaller of the 2 p-values for the treatment difference was tested at the 0.025 level. If significant, testing proceeded for the remaining secondary endpoint at the 0.05 level. If the smaller p-value was \> 0.025, the null hypothesis for the associated variable would not be rejected, and testing of the second endpoint would not proceed.||||<0.001
72592120|NCT02612610|144715418|OTHER||LS Mean Difference|-0.25||||0.0971|TWO_SIDED|95.0|-0.54|0.05|||Mixed Effect Repeated Measures model|||Estimated treatment differences (gefapixant vs. placebo) and corresponding 95% confidence intervals (CIs) were estimated using a mixed effect repeated measures (MMRM) model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value (on log scale) as a covariate.||0.05|-0.54|0.0971
72592121|NCT02612610|144715418|OTHER||LS Mean Difference|-0.25||||0.0928|TWO_SIDED|95.0|-0.54|0.04|||Mixed Effect Repeated Measures model|||Estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value (on log scale) as a covariate.||0.04|-0.54|0.0928
72414557|NCT01358526|144339096|SUPERIORITY_OR_OTHER|||||||0.0006|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test: responder as dependent variable, treatment as explanatory variable, dose at time of randomization as stratifying factor||Proportion of subjects with a response to treatment that is ≥ 30%||||0.0006
72592122|NCT02612610|144715418|OTHER||LS Mean Difference|-0.46||||0.0027|TWO_SIDED|95.0|-0.76|-0.16|||Mixed Effect Repeated Measures model|||Estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value (on log scale) as a covariate.||-0.16|-0.76|0.0027
72592123|NCT02612610|144715419|OTHER||LS Mean Difference|-0.19||||0.1914|TWO_SIDED|95.0|-0.47|0.09|||Mixed Effect Repeated Measures model|||"Day 28 24-hour Cough Frequency: 7.5 mg gefapixant vs. placebo~Day 28 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value (on log scale) as a covariate."||0.09|-0.47|0.1914
72592124|NCT02612610|144715419|OTHER||LS Mean Difference|-0.05||||0.7099|TWO_SIDED|95.0|-0.33|0.23|||Mixed Effect Repeated Measures model|||"Day 28 24-hour Cough Frequency: 20 mg gefapixant vs. placebo~Day 28 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value (on log scale) as a covariate."||0.23|-0.33|0.7099
72592125|NCT02612610|144715419|OTHER||LS Mean Difference|-0.52||||0.0003|TWO_SIDED|95.0|-0.8|-0.24|||Mixed Effect Repeated Measures model|||"Day 28 24-hour Cough Frequency: 50 mg gefapixant vs. placebo~Day 28 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value (on log scale) as a covariate."||-0.24|-0.80|0.0003
72592126|NCT02612610|144715420|OTHER||LS Mean Difference|-0.4||||0.0099|TWO_SIDED|95.0|-0.71|-0.1|||Mixed Effect Repeated Measures model|||"Day 56 24-hour Cough Frequency: 7.5 mg gefapixant vs. placebo~Day 56 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value (on log scale) as a covariate."||-0.10|-0.71|0.0099
72592127|NCT02612610|144715420|OTHER||LS Mean Difference|-0.28||||0.0695|TWO_SIDED|95.0|-0.58|0.02|||Mixed Effect Repeated Measures model|||"Day 56 24-hour Cough Frequency: 20 mg gefapixant vs. placebo~Day 56 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value (on log scale) as a covariate."||0.02|-0.58|0.0695
72592128|NCT02612610|144715420|OTHER||LS Mean Difference|-0.62||||0.0001|TWO_SIDED|95.0|-0.93|-0.31|||Mixed Effect Repeated Measures model|||"Day 56 24-hour Cough Frequency: 50 mg gefapixant vs. placebo~Day 56 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value (on log scale) as a covariate."||-0.31|-0.93|0.0001
72592129|NCT02612610|144715421|OTHER||LS Mean Difference|-0.24||||0.0991|TWO_SIDED|95.0|-0.52|0.04|||Mixed Effect Repeated Measures model|||"Day 84 24-hour Cough Frequency: 7.5 mg gefapixant vs. placebo~Day 84 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value (on log scale) as a covariate."||0.04|-0.52|0.0991
72592130|NCT02612610|144715421|OTHER||LS Mean Difference|-0.25||||0.0811|TWO_SIDED|95.0|-0.53|0.03|||Mixed Effect Repeated Measures model|||"Day 84 24-hour Cough Frequency: 20 mg gefapixant vs. placebo~Day 84 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value (on log scale) as a covariate."||0.03|-0.53|0.0811
72592131|NCT02612610|144715421|OTHER||LS Mean Difference|-0.47||||0.0014|TWO_SIDED|95.0|-0.76|-0.19|||Mixed Effect Repeated Measures model|||"Day 84 24-hour Cough Frequency: 50 mg gefapixant vs. placebo~Day 84 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value (on log scale) as a covariate."||-0.19|-0.76|0.0014
72592132|NCT02612610|144715422|OTHER||LS Mean Difference|-0.21||||0.1468|TWO_SIDED|95.0|-0.5|0.07|||Mixed Effect Repeated Measures model|||"Day 28 Awake Cough Frequency: 7.5 mg gefapixant vs. placebo~Day 28 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value (on log scale) as a covariate. ."||0.07|-0.50|0.1468
72592133|NCT02612610|144715422|OTHER||LS Mean Difference|-0.08||||0.5874|TWO_SIDED|95.0|-0.36|0.2|||Mixed Effect Repeated Measures model|||"Day 28 Awake Cough Frequency: 20 mg gefapixant vs. placebo~Day 28 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value (on log scale) as a covariate."||0.20|-0.36|0.5874
72592134|NCT02612610|144715422|OTHER||LS Mean Difference|-0.49||||0.0008|TWO_SIDED|95.0|-0.78|-0.21|||Mixed Effect Repeated Measures model|||"Day 28 24-hour Cough Frequency: 50 mg gefapixant vs. placebo~Day 28 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value (on log scale) as a covariate."||-0.21|-0.78|0.0008
72592135|NCT02612610|144715423|OTHER||Mixed Effect Repeated Measures model|-0.39||||0.0177|TWO_SIDED|95.0|-0.7|-0.07|||Mixed Effect Repeated Measures model|||"Day 56 Awake Cough Frequency: 7.5 mg gefapixant vs. placebo~Day 56 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value (on log scale) as a covariate."||-0.07|-0.70|0.0177
72592136|NCT02612610|144715423|OTHER||LS Mean Difference|-0.32||||0.0498|TWO_SIDED|95.0|-0.63|0.0|||Mixed Effect Repeated Measures model|||"Day 56 Awake Cough Frequency: 20 mg gefapixant vs. placebo~Day 56 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value (on log scale) as a covariate."||-0.00|-0.63|0.0498
72592137|NCT02612610|144715423|OTHER||LS Mean Difference|-0.59||||0.0004|TWO_SIDED|95.0|-0.92|-0.27|||Mixed Effect Repeated Measures model|||"Day 56 Awake Cough Frequency: 50 mg gefapixant vs. placebo~Day 56 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value (on log scale) as a covariate."||-0.27|-0.92|0.0004
72592138|NCT02612610|144715425|OTHER||LS Mean Difference|-6.4||||0.1318|TWO_SIDED|95.0|-14.8|1.9|||Mixed Effect Repeated Measures model|||"Day 28 Cough Severity VAS: 7.5 mg gefapixant vs. placebo~Day 28 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||1.9|-14.8|0.1318
72592139|NCT02612610|144715425|OTHER||LS Mean Difference|-2.9||||0.4917|TWO_SIDED|95.0|-11.3|5.4|||Mixed Effect Repeated Measures model|||"Day 28 Cough Severity VAS: 20 mg gefapixant vs. placebo~Day 28 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||5.4|-11.3|0.4917
72592140|NCT02612610|144715425|OTHER||LS Mean Difference|-9.8||||0.0228|TWO_SIDED|95.0|-18.2|-1.4|||Mixed Effect Repeated Measures model|||"Day 28 Cough Severity VAS: 50 mg gefapixant vs. placebo~Day 28 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||-1.4|-18.2|0.0228
72592141|NCT02612610|144715426|OTHER||LS Mean Difference|-2.6||||0.554|TWO_SIDED|95.0|-11.5|6.2|||Mixed Effect Repeated Measures model|||"Day 56 Cough Severity VAS: 7.5 mg gefapixant vs. placebo~Day 56 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||6.2|-11.5|0.5540
72592142|NCT02612610|144715426|OTHER||LS Mean Difference|-3.2||||0.4702|TWO_SIDED|95.0|-12.0|5.6|||Mixed Effect Repeated Measures model|||"Day 56 Cough Severity VAS: 20 mg gefapixant vs. placebo~Day 56 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||5.6|-12.0|0.4702
72414558|NCT01358526|144339097|SUPERIORITY_OR_OTHER|||||||0.0018|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test: responder as dependent variable, treatment as explanatory variable, dose at time of randomization as stratifying factor||Proportion of subjects with a response to treatment that is ≥ 50%||||0.0018
72414559|NCT02194621|144339165|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||The null hypothesis states that there is no difference between groups.||||>0.05
72414560|NCT02194621|144339166|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||<0.001
72592143|NCT02612610|144715426|OTHER||LS Mean Difference|-10.7||||0.0197|TWO_SIDED|95.0|-19.8|-1.7|||Mixed Effect Repeated Measures model|||"Day 56 Cough Severity VAS: 50 mg gefapixant vs. placebo~Day 56 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||-1.7|-19.8|0.0197
72592144|NCT02612610|144715427|OTHER||LS Mean Difference|-4.4||||0.302|TWO_SIDED|95.0|-12.9|4.0|||Mixed Effect Repeated Measures model|||"Day 84 Cough Severity VAS: 7.5 mg gefapixant vs. placebo~Day 84 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||4.0|-12.9|0.3020
72592145|NCT02612610|144715427|OTHER||LS Mean Difference|-6.4||||0.1365|TWO_SIDED|95.0|-14.8|2.0|||Mixed Effect Repeated Measures model|||"Day 84 Cough Severity VAS: 20 mg gefapixant vs. placebo~Day 84 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||2.0|-14.8|0.1365
72592146|NCT02612610|144715427|OTHER||LS Mean Difference|-11.2||||0.0108|TWO_SIDED|95.0|-19.7|-2.6|||Mixed Effect Repeated Measures model|||"Day 84 Cough Severity VAS: 50 mg gefapixant vs. placebo~Day 84 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||-2.6|-19.7|0.0108
72592147|NCT02612610|144715428|OTHER||LS Mean Difference|-4.0||||0.3509|TWO_SIDED|95.0|-12.3|4.4|||Mixed Effect Repeated Measures model|||"Day 85/Early Termination Cough Severity VAS: 7.5 mg gefapixant vs. placebo~Day 85/Early Termination estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||4.4|-12.3|0.3509
72592148|NCT02612610|144715428|OTHER||LS Mean Difference|-8.2||||0.0519|TWO_SIDED|95.0|-16.6|0.1|||Mixed Effect Repeated Measures model|||"Day 85/Early Termination Cough Severity VAS: 7.5 mg gefapixant vs. placebo~Day 85/Early Termination estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.1|-16.6|0.0519
72592149|NCT02612610|144715428|OTHER||LS Mean Difference|-15.9||||0.0003|TWO_SIDED|95.0|-24.3|-7.5|||Mixed Effect Repeated Measures model|||"Day 85/Early Termination Cough Severity VAS: 50 mg gefapixant vs. placebo~Day 85/Early Termination estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||-7.5|-24.3|0.0003
72592150|NCT02612610|144715429|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1387|||||||Cochran-Mantel-Haenszel|||"Day 28: ≥70% Change: 7.5 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a generalized linear mixed model (GLMM) with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified Cochran Mantel Haenszel (CMH) test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.1387
72592151|NCT02612610|144715429|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7238|||||||Cochran-Mantel-Haenszel|||"Day 28: ≥70% Change: 20 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.7238
72592152|NCT02612610|144715429|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0144|||||||Cochran-Mantel-Haenszel|||"Day 28: ≥70% Change: 50 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.0144
72592153|NCT02612610|144715429|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0922|||||||Cochran-Mantel-Haenszel|||"Day 28: ≥50% Change: 7.5 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.0922
72592154|NCT02612610|144715429|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3812|||||||Cochran-Mantel-Haenszel|||"Day 28: ≥50% Change: 20 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.3812
72592155|NCT02612610|144715429|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0088|||||||Cochran-Mantel-Haenszel|||"Day 28: ≥50% Change: 50 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.0088
72592156|NCT02612610|144715429|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0653|||||||Cochran-Mantel-Haenszel|||"Day 28: ≥30% Change: 7.5 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.0653
72414561|NCT02194621|144339167|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||The null hypothesis states that there is no difference between groups.||||>0.05
72592157|NCT02612610|144715429|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6443|||||||Cochran-Mantel-Haenszel|||"Day 28: ≥30% Change: 20 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.6443
72414562|NCT02194621|144339168|SUPERIORITY_OR_OTHER|||||||0.002|||||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.002
72592158|NCT02612610|144715429|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1511|||||||Cochran-Mantel-Haenszel|||"Day 28: ≥30% Change: 50 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.1511
72592159|NCT02612610|144715430|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0045|||||||Cochran-Mantel-Haenszel|||"Day 56: ≥70% Change: 7.5 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a generalized linear mixed model (GLMM) with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified Cochran Mantel Haenszel (CMH) test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.0045
72592160|NCT02612610|144715430|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0947|||||||Cochran-Mantel-Haenszel|||"Day 56: ≥70% Change: 20 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.0947
72592161|NCT02612610|144715430|SUPERIORITY_OR_OTHER_LEGACY|||||||0.008|||||||Cochran-Mantel-Haenszel|||"Day 56: ≥70% Change: 50 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.0080
72592162|NCT02612610|144715430|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0283|||||||Cochran-Mantel-Haenszel|||"Day 56: ≥50% Change: 7.5 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.0283
72592163|NCT02612610|144715430|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1493|||||||Cochran-Mantel-Haenszel|||"Day 56: ≥50% Change: 20 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.1493
72592164|NCT02612610|144715430|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0026|||||||Cochran-Mantel-Haenszel|||"Day 56: ≥50% Change: 50 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.0026
72592165|NCT02612610|144715430|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0652|||||||Cochran-Mantel-Haenszel|||"Day 56: ≥30% Change: 7.5 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.0652
72592166|NCT02612610|144715430|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3601|||||||Cochran-Mantel-Haenszel|||"Day 56: ≥30% Change: 20 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.3601
72414563|NCT01808690|144339269|SUPERIORITY|||||||0.005||||||Threshold for statistical significance P=0.05|Regression, Linear|We also fitted multivariable models, which included sex, pubertal status, change in BMI, and baseline M/I.||Insulin function was defined as M/I (mg/kg/min)/(insulin). Power calculations were based on data from a small study in youth with poorly controlled T1DM, which reported a significant increase in M/I in the 11 participants treated with Metformin. On the basis of the effect size reported in that study, a sample size of 25 per group and an alpha of 0.05 provided us with 93% power to detect a difference of 1 SD in the primary outcome of M/I.||||0.005
72414564|NCT01808690|144339270|SUPERIORITY|||||||0.46||||||Threshold for statistical significance P=0.05|Regression, Linear|Adjusted for the baseline value of the variable, sex, age, change in VO2peak, change in insulin sensitivity, and treatment condition.||||||0.46
72414565|NCT01808690|144339271|SUPERIORITY|||||||0.04||||||Threshold for statistical significance P=0.05|Regression, Linear|We also fitted mutlivariable models, which included changed in SBP, change in BMI, and change in M/I.||||||0.04
72592167|NCT02612610|144715430|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0086|||||||Cochran-Mantel-Haenszel|||"Day 56: ≥30% Change: 50 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.0086
72592168|NCT02612610|144715431|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3893|||||||Cochran-Mantel-Haenszel|||"Day 84: ≥70% Change: 7.5 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a generalized linear mixed model (GLMM) with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified Cochran Mantel Haenszel (CMH) test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.3893
72592169|NCT02612610|144715431|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2803|||||||Cochran-Mantel-Haenszel|||"Day 84: ≥70% Change: 20 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.2803
72592170|NCT02612610|144715431|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0427|||||||Cochran-Mantel-Haenszel|||"Day 84: ≥70% Change: 50 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.0427
72592171|NCT02612610|144715431|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0209|||||||Cochran-Mantel-Haenszel|||"Day 84: ≥50% Change: 7.5 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.0209
72592172|NCT02612610|144715431|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3401|||||||Cochran-Mantel-Haenszel|||"Day 84: ≥50% Change: 20 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.3401
72592173|NCT02612610|144715431|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0031|||||||Cochran-Mantel-Haenszel|||"Day 84: ≥50% Change: 50 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.0031
72592174|NCT02612610|144715431|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0283|||||||Cochran-Mantel-Haenszel|||"Day 84: ≥30% Change: 7.5 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.0283
72592175|NCT02612610|144715431|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6233|||||||Cochran-Mantel-Haenszel|||"Day 84: ≥30% Change: 20 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.6233
72592176|NCT02612610|144715431|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0001|||||||Cochran-Mantel-Haenszel|||"Day 84: ≥30% Change: 50 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.0001
72592177|NCT02612610|144715432|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4925|||||||Cochran-Mantel-Haenszel|||"Day 98: ≥70% Change: 7.5 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a generalized linear mixed model (GLMM) with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified Cochran Mantel Haenszel (CMH) test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.4925
72592178|NCT02612610|144715432|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9007|||||||Cochran-Mantel-Haenszel|||"Day 98: ≥70% Change: 20 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.9007
72592179|NCT02612610|144715432|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1602|||||||Cochran-Mantel-Haenszel|||"Day 98: ≥70% Change: 50 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.1602
72592180|NCT02612610|144715432|SUPERIORITY_OR_OTHER_LEGACY|||||||0.344|||||||Cochran-Mantel-Haenszel|||"Day 98: ≥50% Change: 7.5 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.3440
72592181|NCT02612610|144715432|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9876|||||||Cochran-Mantel-Haenszel|||"Day 98: ≥50% Change: 20 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.9876
72592182|NCT02612610|144715432|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0993|||||||Cochran-Mantel-Haenszel|||"Day 98: ≥50% Change: 50 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.0993
72592183|NCT02612610|144715432|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5968|||||||Cochran-Mantel-Haenszel|||"Day 98: ≥30% Change: 7.5 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.5968
72592184|NCT02612610|144715432|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8726|||||||Cochran-Mantel-Haenszel|||"Day 98: ≥30% Change: 20 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.8726
72592185|NCT02612610|144715432|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4092|||||||Cochran-Mantel-Haenszel|||"Day 98: ≥30% Change: 50 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.4092
72592186|NCT02612610|144715433|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0781|||||||Cochran-Mantel-Haenszel|||"Day 28: ≥70% Change: 7.5 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a generalized linear mixed model (GLMM) with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified Cochran Mantel Haenszel (CMH) test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.0781
72592187|NCT02612610|144715433|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7098|||||||Cochran-Mantel-Haenszel|||"Day 28: ≥70% Change: 20 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.7098
72592188|NCT02612610|144715433|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0068|||||||Cochran-Mantel-Haenszel|||"Day 28: ≥70% Change: 50 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.0068
72592189|NCT02612610|144715433|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1284|||||||Cochran-Mantel-Haenszel|||"Day 28: ≥50% Change: 7.5 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.1284
72414566|NCT01808690|144339272|SUPERIORITY|||||||0.04||||||Threshold for significance P=0.05|Regression, Linear|We also fitted mutlivariable models, which included changed in systolic blood pressure, change in BMI, and change in M/I.||||||0.04
72414567|NCT01808690|144339273|SUPERIORITY|||||||0.01||||||Threshold for statistical significance P=0.05|Regression, Linear|Adjusted for the baseline value of BMI percentile, diabetes duration, and A1c.||||||0.01
72414568|NCT01808690|144339274|SUPERIORITY|||||||0.03||||||Threshold for statistical significance P=0.05|Regression, Linear|We also fitted mutlivariable models, which included changed in SBP, change in BMI, and change in M/I.||||||0.03
72592190|NCT02612610|144715433|SUPERIORITY_OR_OTHER_LEGACY|||||||0.267|||||||Cochran-Mantel-Haenszel|||"Day 28: ≥50% Change: 20 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.2670
72592191|NCT02612610|144715433|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0013|||||||Cochran-Mantel-Haenszel|||"Day 28: ≥50% Change: 50 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.0013
72592192|NCT02612610|144715433|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4343|||||||Cochran-Mantel-Haenszel|||"Day 28: ≥30% Change: 7.5 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.4343
72592193|NCT02612610|144715433|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5384|||||||Cochran-Mantel-Haenszel|||"Day 28: ≥30% Change: 20 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.5384
72592194|NCT02612610|144715433|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0822|||||||Cochran-Mantel-Haenszel|||"Day 28: ≥30% Change: 50 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.0822
72592195|NCT02612610|144715434|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0006|||||||Cochran-Mantel-Haenszel|||"Day 56: ≥70% Change: 7.5 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a generalized linear mixed model (GLMM) with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified Cochran Mantel Haenszel (CMH) test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.0006
72592196|NCT02612610|144715434|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0223|||||||Cochran-Mantel-Haenszel|||"Day 56: ≥70% Change: 20 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.0223
72592197|NCT02612610|144715434|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0001|||||||Cochran-Mantel-Haenszel|||"Day 56: ≥70% Change: 50 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.0001
72592198|NCT02612610|144715434|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0165|||||||Cochran-Mantel-Haenszel|||"Day 56: ≥50% Change: 7.5 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.0165
72414569|NCT01808690|144339275|SUPERIORITY|||||||0.8||||||Threshold for significance P=0.05|Regression, Linear|We also fitted mutlivariable models, which included changed in systolic blood pressure, change in BMI, and change in M/I.||||||0.8
72592199|NCT02612610|144715434|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6255|||||||Cochran-Mantel-Haenszel|||"Day 56: ≥50% Change: 20 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.6255
72421550|NCT01181726|144354233|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|97.99|||||TWO_SIDED|90.0|94.11|102.02|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||102.02|94.11|
72592200|NCT02612610|144715434|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0085|||||||Cochran-Mantel-Haenszel|||"Day 56: ≥50% Change: 50 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.0085
72592201|NCT02612610|144715434|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0722|||||||Cochran-Mantel-Haenszel|||"Day 56: ≥30% Change: 7.5 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.0722
72592202|NCT02612610|144715434|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3577|||||||Cochran-Mantel-Haenszel|||"Day 56: ≥30% Change: 20 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.3577
72592203|NCT02612610|144715434|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0006|||||||Cochran-Mantel-Haenszel|||"Day 56: ≥30% Change: 50 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.0006
72592204|NCT02612610|144715435|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3845|||||||Cochran-Mantel-Haenszel|||"Day 84: ≥70% Change: 7.5 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a generalized linear mixed model (GLMM) with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified Cochran Mantel Haenszel (CMH) test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.3845
72592205|NCT02612610|144715435|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1177|||||||Cochran-Mantel-Haenszel|||"Day 84: ≥70% Change: 20 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.1177
72592206|NCT02612610|144715435|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0236|||||||Cochran-Mantel-Haenszel|||"Day 84: ≥70% Change: 50 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.0236
72592207|NCT02612610|144715435|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0192|||||||Cochran-Mantel-Haenszel|||"Day 84: ≥50% Change: 7.5 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.0192
72592208|NCT02612610|144715435|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3301|||||||Cochran-Mantel-Haenszel|||"Day 84: ≥50% Change: 20 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.3301
72592209|NCT02612610|144715435|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0008|||||||Cochran-Mantel-Haenszel|||"Day 84: ≥50% Change: 50 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.0008
72592210|NCT02612610|144715435|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0285|||||||Cochran-Mantel-Haenszel|||"Day 84: ≥30% Change: 7.5 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.0285
72592211|NCT02612610|144715435|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3856|||||||Cochran-Mantel-Haenszel|||"Day 84: ≥30% Change: 20 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.3856
72592212|NCT02612610|144715435|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0001|||||||Cochran-Mantel-Haenszel|||"Day 84: ≥30% Change: 50 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.0001
72592213|NCT02612610|144715436|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2441|||||||Cochran-Mantel-Haenszel|||"Day 98: ≥70% Change: 7.5 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a generalized linear mixed model (GLMM) with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified Cochran Mantel Haenszel (CMH) test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.2441
72592214|NCT02612610|144715436|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5055|||||||Cochran-Mantel-Haenszel|||"Day 98: ≥70% Change: 20 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.5055
72592215|NCT02612610|144715436|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1602|||||||Cochran-Mantel-Haenszel|||"Day 98: ≥70% Change: 50 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.1602
72592216|NCT02612610|144715436|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2721|||||||Cochran-Mantel-Haenszel|||"Day 98: ≥50% Change: 7.5 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.2721
72592217|NCT02612610|144715436|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9763|||||||Cochran-Mantel-Haenszel|||"Day 98: ≥50% Change: 20 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.9763
72592218|NCT02612610|144715436|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0993|||||||Cochran-Mantel-Haenszel|||"Day 98: ≥50% Change: 50 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.0993
72592219|NCT02612610|144715436|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4575|||||||Cochran-Mantel-Haenszel|||"Day 98: ≥30% Change: 7.5 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.4575
72592220|NCT02612610|144715436|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9706|||||||Cochran-Mantel-Haenszel|||"Day 98: ≥30% Change: 20 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.9706
72592221|NCT02612610|144715436|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3258|||||||Cochran-Mantel-Haenszel|||"Day 98: ≥30% Change: 50 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.3258
72592222|NCT02612610|144715437|OTHER||LS Mean Difference|0.0||||0.9858|TWO_SIDED|95.0|-0.53|0.54|||Mixed Effect Repeated Measures model|||"Day 28 Sleep Cough Frequency: 7.5 mg gefapixant vs. placebo~Day 28 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value (on log scale) as a covariate."||0.54|-0.53|0.9858
72592223|NCT02612610|144715437|OTHER||LS Mean Difference|-0.01||||0.9813|TWO_SIDED|95.0|-0.53|0.52|||Mixed Effect Repeated Measures model|||"Day 28 Sleep Cough Frequency: 20 mg gefapixant vs. placebo~Day 28 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value (on log scale) as a covariate."||0.52|-0.53|0.9813
72592224|NCT02612610|144715437|OTHER||LS Mean Difference|-0.11||||0.6746|TWO_SIDED|95.0|-0.65|0.42|||Mixed Effect Repeated Measures model|||"Day 28 Sleep Cough Frequency: 50 mg gefapixant vs. placebo~Day 28 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value (on log scale) as a covariate."||0.42|-0.65|0.6746
72592225|NCT02612610|144715438|OTHER||LS Mean Difference|-0.32||||0.2583|TWO_SIDED|95.0|-0.88|0.24|||Mixed Effect Repeated Measures model|||"Day 56 Sleep Cough Frequency: 7.5 mg gefapixant vs. placebo~Day 56 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value (on log scale) as a covariate."||0.24|-0.88|0.2583
72414570|NCT01880424|144339283|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.59||||0.001||95.0|1.21|2.09||Statistical significance (p\<0.05) was required in both co-primary efficacy parameters to meet the primary efficacy objective; both p-values met this criterion.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test controlling for geographic region|Odds ratio for response rate (linaclotide : placebo)|Null Hypothesis: There is no difference between the linaclotide dose and placebo in the proportion of 12-week Abdominal Pain/Abdominal Discomfort Responders or there is no difference in the proportion of 12-week IBS Degree of Relief Responders. With 800 planned patients, the statistical power was expected to be approximately 95%, with an overall type I error rate controlled at the 0.05 level (2-sided), based on assumptions from NCT00948818 (LIN-MD-31) study data.||2.09|1.21|0.0010
72592226|NCT02612610|144715438|OTHER||LS Mean Difference|0.01||||0.9826|TWO_SIDED|95.0|-0.55|0.56|||Mixed Effect Repeated Measures model|||"Day 56 Sleep Cough Frequency: 20 mg gefapixant vs. placebo~Day 56 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value (on log scale) as a covariate."||0.56|-0.55|0.9826
72592227|NCT02612610|144715438|OTHER||LS Mean Difference|-0.4||||0.1672|TWO_SIDED|95.0|-0.98|0.17|||Mixed Effect Repeated Measures model|||"Day 56 Sleep Cough Frequency: 50 mg gefapixant vs. placebo~Day 56 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value (on log scale) as a covariate."||0.17|-0.98|0.1672
72592228|NCT02612610|144715439|OTHER||LS Mean Difference|0.14||||0.6102|TWO_SIDED|95.0|-0.4|0.68|||Mixed Effect Repeated Measures model|||"Day 84 Sleep Cough Frequency: 7.5 mg gefapixant vs. placebo~Day 84 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value (on log scale) as a covariate."||0.68|-0.4|0.6102
72592229|NCT02612610|144715439|OTHER||LS Mean Difference|0.08||||0.7782|TWO_SIDED|95.0|-0.46|0.61|||Mixed Effect Repeated Measures model|||"Day 84 Sleep Cough Frequency: 20 mg gefapixant vs. placebo~Day 84 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value (on log scale) as a covariate."||0.61|-0.46|0.7782
72592230|NCT02612610|144715439|OTHER||LS Mean Difference|0.28||||0.3167|TWO_SIDED|95.0|-0.27|0.83|||Mixed Effect Repeated Measures model|||"Day 84 Sleep Cough Frequency: 50 mg gefapixant vs. placebo~Day 84 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value (on log scale) as a covariate."||0.83|-0.27|0.3167
72592231|NCT02612610|144715440|OTHER||LS Mean Difference|0.3||||0.1545|TWO_SIDED|95.0|-0.1|0.7|||Mixed Effect Repeated Measures model|||"Week 1 CSD Total Score: 7.5 mg gefapixant vs. placebo~Week 1 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.7|-0.1|0.1545
72592232|NCT02612610|144715440|OTHER||LS Mean Difference|0.3||||0.2013|TWO_SIDED|95.0|-0.1|0.7|||Mixed Effect Repeated Measures model|||"Week 1 CSD Total Score: 20 mg gefapixant vs. placebo~Week 1 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.7|-0.1|0.2013
72592233|NCT02612610|144715440|OTHER||LS Mean Difference|0.0||||0.9962|TWO_SIDED|95.0|-0.4|0.4|||Mixed Effect Repeated Measures model|||"Week 1 CSD Total Score: 50 mg gefapixant vs. placebo~Week 1 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.4|-0.4|0.9962
72592234|NCT02612610|144715441|OTHER||LS Mean Difference|0.1||||0.7328|TWO_SIDED|95.0|-0.4|0.6|||Mixed Effect Repeated Measures model|||"Week 2 CSD Total Score: 7.5 mg gefapixant vs. placebo~Week 2 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.6|-0.4|0.7328
72592235|NCT02612610|144715441|OTHER||LS Mean Difference|0.1||||0.7635|TWO_SIDED|95.0|-0.4|0.6|||Mixed Effect Repeated Measures model|||"Week 2 CSD Total Score: 20 mg gefapixant vs. placebo~Week 2 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.6|-0.4|0.7635
72592236|NCT02612610|144715441|OTHER||LS Mean Difference|-0.4||||0.0951|TWO_SIDED|95.0|-0.9|0.1|||Mixed Effect Repeated Measures model|||"Week 2 CSD Total Score: 50 mg gefapixant vs. placebo~Week 2 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.1|-0.9|0.0951
72592237|NCT02612610|144715442|OTHER||LS Mean Difference|-0.2||||0.5797|TWO_SIDED|95.0|-0.7|0.4|||Mixed Effect Repeated Measures model|||"Week 3 CSD Total Score: 7.5 mg gefapixant vs. placebo~Week 3 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.4|-0.7|0.5797
72414571|NCT01880424|144339284|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.56|||<|0.0001||95.0|1.83|3.58||Statistical significance (p\<0.05) was required in both co-primary efficacy parameters to meet the primary efficacy objective; both p-values met this criterion.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test controlling for geographic region|Odds ratio for response rate (linaclotide : placebo)|Null Hypothesis: There is no difference between the linaclotide dose and placebo in the proportion of 12-week Abdominal Pain/Abdominal Discomfort Responders or there is no difference in the proportion of 12-week IBS Degree of Relief Responders. With 800 planned patients, the statistical power was expected to be approximately 95%, with an overall type I error rate controlled at the 0.05 level (2-sided), based on assumptions from NCT00948818 (LIN-MD-31) study data.||3.58|1.83|<0.0001
72414572|NCT04969250|144339295|SUPERIORITY|||||||0.73|||||||Fisher Exact|||||||0.73
72592238|NCT02612610|144715442|OTHER||LS Mean Difference|-0.3||||0.2499|TWO_SIDED|95.0|-0.9|0.2|||Mixed Effect Repeated Measures model|||"Week 3 CSD Total Score: 20 mg gefapixant vs. placebo~Week 3 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.2|-0.9|0.2499
72414573|NCT04969250|144339296|SUPERIORITY|||||||0.4|||||||Fisher Exact|||||||0.40
72592239|NCT02612610|144715442|OTHER||LS Mean Difference|-0.5||||0.0612|TWO_SIDED|95.0|-1.1|0.0|||Mixed Effect Repeated Measures model|||"Week 3 CSD Total Score: 50 mg gefapixant vs. placebo~Week 3 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.0|-1.1|0.0612
72592240|NCT02612610|144715443|OTHER||LS Mean Difference|-0.2||||0.5358|TWO_SIDED|95.0|-0.7|0.4|||Mixed Effect Repeated Measures model|||"Week 4 CSD Total Score: 7.5 mg gefapixant vs. placebo~Week 4 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.4|-0.7|0.5358
72592241|NCT02612610|144715443|OTHER||LS Mean Difference|-0.3||||0.3129|TWO_SIDED|95.0|-0.8|0.3|||Mixed Effect Repeated Measures model|||"Week 4 CSD Total Score: 20 mg gefapixant vs. placebo~Week 4 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.3|-0.8|0.3129
72592242|NCT02612610|144715443|OTHER||LS Mean Difference|-0.5||||0.1046|TWO_SIDED|95.0|-1.0|0.1|||Mixed Effect Repeated Measures model|||"Week 4 CSD Total Score: 50 mg gefapixant vs. placebo~Week 4 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.1|-1.0|0.1046
72592243|NCT02612610|144715444|OTHER||LS Mean Difference|-0.2||||0.5796|TWO_SIDED|95.0|-0.7|0.4|||Mixed Effect Repeated Measures model|||"Week 5 CSD Total Score: 7.5 mg gefapixant vs. placebo~Week 5 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.4|-0.7|0.5796
72592244|NCT02612610|144715444|OTHER||LS Mean Difference|-0.4||||0.143|TWO_SIDED|95.0|-1.0|0.1|||Mixed Effect Repeated Measures model|||"Week 5 CSD Total Score: 20 mg gefapixant vs. placebo~Week 5 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.1|-1.0|0.1430
72592245|NCT02612610|144715444|OTHER||LS Mean Difference|-0.7||||0.0221|TWO_SIDED|95.0|-1.2|-0.1|||Mixed Effect Repeated Measures model|||"Week 5 CSD Total Score: 50 mg gefapixant vs. placebo~Week 5 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||-0.1|-1.2|0.0221
72414574|NCT04969250|144339297|SUPERIORITY|||||||0.078|||||||Fisher Exact|||||||0.078
72414575|NCT04969250|144339298|SUPERIORITY|||||||0.033|||||||Fisher Exact|||||||0.033
72592246|NCT02612610|144715445|OTHER||LS Mean Difference|-0.4||||0.1562|TWO_SIDED|95.0|-1.0|0.2|||Mixed Effect Repeated Measures model|||"Week 6 CSD Total Score: 7.5 mg gefapixant vs. placebo~Week 6 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.2|-1.0|0.1562
72592247|NCT02612610|144715445|OTHER||LS Mean Difference|-0.5||||0.071|TWO_SIDED|95.0|-1.1|0.0|||Mixed Effect Repeated Measures model|||"Week 6 CSD Total Score: 20 mg gefapixant vs. placebo~Week 6 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.0|-1.1|0.0710
72421551|NCT01264380|144354234|SUPERIORITY_OR_OTHER||Ratio of Geometric Mean|4.64|||||TWO_SIDED|90.0|2.83|7.6||||||The point estimate and 90 percent (%) confidence interval (CI) of vemurafenib plasma AUC geometric means ratios of the Fed to Fasted conditions following an oral administration of a single dose of 960 mg vemurafenib were analyzed.||7.60|2.83|
72592248|NCT02612610|144715445|OTHER||LS Mean Difference|-0.7||||0.0274|TWO_SIDED|95.0|-1.2|-0.1|||Mixed Effect Repeated Measures model|||"Week 6 CSD Total Score: 50 mg gefapixant vs. placebo~Week 6 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||-0.1|-1.2|0.0274
72592249|NCT02612610|144715446|OTHER||LS Mean Difference|-0.2||||0.4464|TWO_SIDED|95.0|-0.8|0.4|||Mixed Effect Repeated Measures model|||"Week 7 CSD Total Score: 7.5 mg gefapixant vs. placebo~Week 7 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.4|-0.8|0.4464
72592250|NCT02612610|144715446|OTHER||LS Mean Difference|-0.3||||0.332|TWO_SIDED|95.0|-0.9|0.3|||Mixed Effect Repeated Measures model|||"Week 7 CSD Total Score: 20 mg gefapixant vs. placebo~Week 7 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.3|-0.9|0.3320
72592251|NCT02612610|144715446|OTHER||LS Mean Difference|-0.5||||0.0792|TWO_SIDED|95.0|-1.1|0.1|||Mixed Effect Repeated Measures model|||"Week 7 CSD Total Score: 50 mg gefapixant vs. placebo~Week 7 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.1|-1.1|0.0792
72592252|NCT02612610|144715447|OTHER||LS Mean Difference|-0.2||||0.4716|TWO_SIDED|95.0|-0.8|0.4|||Mixed Effect Repeated Measures model|||"Week 8 CSD Total Score: 7.5 mg gefapixant vs. placebo~Week 8 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.4|-0.8|0.4716
72414576|NCT01059565|144339306|SUPERIORITY_OR_OTHER||Difference in least squares mean (LSM)|0.91||||0.663|TWO_SIDED|95.0|-3.24|5.06||"To correct for multiplicity, a family alpha spending rule was used to control the type 1 error rate of alpha=0.05.~A gate-keeping procedure to control family-wise Type 1 error was established a priori for primary and key secondary endpoints."|ANCOVA|Baseline was included as a covariate in this model.||"The primary analysis was a test for superiority. Null hypothesis was no difference between the AZLI and placebo treatment groups versus the alternative hypothesis that there was a difference.~A sample size of 50 participants per group provided at least 80% power to detect an 8.5% difference in mean AUCave of relative change from baseline in FEV1 % predicted through Week 24 using a two-sided 0.05-level test, assuming a common standard deviation of 15."||5.06|-3.24|0.663
72592253|NCT02612610|144715447|OTHER||LS Mean Difference|-0.2||||0.4371|TWO_SIDED|95.0|-0.8|0.4|||Mixed Effect Repeated Measures model|||"Week 8 CSD Total Score: 20 mg gefapixant vs. placebo~Week 8 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.4|-0.8|0.4371
72592254|NCT02612610|144715447|OTHER||LS Mean Difference|-0.4||||0.1907|TWO_SIDED|95.0|-1.0|0.2|||Mixed Effect Repeated Measures model|||"Week 8 CSD Total Score: 50 mg gefapixant vs. placebo~Week 8 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.2|-1.0|0.1907
72592255|NCT02612610|144715448|OTHER||LS Mean Difference|-0.3||||0.2772|TWO_SIDED|95.0|-0.9|0.3|||Mixed Effect Repeated Measures model|||"Week 9 CSD Total Score: 7.5 mg gefapixant vs. placebo~Week 9 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.3|-0.9|0.2772
72414577|NCT01059565|144339307|SUPERIORITY_OR_OTHER|||||||0.4158||||||To correct for multiplicity, a family alpha spending rule was used to control the type 1 error rate of alpha=0.05.|Negative binomial regression|The negative binomial regression model included an offset parameter which accounted for potential differing study durations due to discontinuations.||The primary analysis was a test for superiority. Null hypothesis was no difference between the AZLI and placebo treatment groups versus the alternative hypothesis that there was a difference.||||0.4158
72414578|NCT01059565|144339308|SUPERIORITY_OR_OTHER||Difference in LSM|0.18||||0.939|TWO_SIDED|95.0|-4.43|1.78||To correct for multiplicity, a family alpha spending rule was used to control the type 1 error rate of alpha=0.05.|ANCOVA|The AUCs of changes from baseline were compared between treatment groups using ANCOVA methods with baseline value as a covariate.||Null hypothesis was that there was no difference between the AZLI and placebo treatment groups versus the alternative hypothesis that there was a difference.||1.78|-4.43|0.939
72414579|NCT01059565|144339309|SUPERIORITY_OR_OTHER||Difference in LSM|0.77||||0.711|TWO_SIDED|95.0|-3.33|4.86|||ANCOVA|The AUCs of changes from baseline were compared between treatment groups using ANCOVA methods with baseline value as a covariate.||Null hypothesis was that there was no difference between the AZLI and placebo treatment groups versus the alternative hypothesis that there was a difference.||4.86|-3.33|0.711
72592256|NCT02612610|144715448|OTHER||LS Mean Difference|-0.5||||0.1132|TWO_SIDED|95.0|-1.1|0.1|||Mixed Effect Repeated Measures model|||"Week 9 CSD Total Score: 20 mg gefapixant vs. placebo~Week 9 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.1|-1.1|0.1132
72592257|NCT02612610|144715448|OTHER||LS Mean Difference|-0.6||||0.0737|TWO_SIDED|95.0|-1.2|0.1|||Mixed Effect Repeated Measures model|||"Week 9 CSD Total Score: 50 mg gefapixant vs. placebo~Week 9 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.1|-1.2|0.0737
72592258|NCT02612610|144715449|OTHER||LS Mean Difference|-0.1||||0.6266|TWO_SIDED|95.0|-0.8|0.5|||Mixed Effect Repeated Measures model|||"Week 10 CSD Total Score: 7.5 mg gefapixant vs. placebo~Week 10 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.5|-0.8|0.6266
72592259|NCT02612610|144715449|OTHER||LS Mean Difference|-0.4||||0.1769|TWO_SIDED|95.0|-1.0|0.2|||Mixed Effect Repeated Measures model|||"Week 10 CSD Total Score: 20 mg gefapixant vs. placebo~Week 10 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.2|-1.0|0.1769
72592260|NCT02612610|144715449|OTHER||LS Mean Difference|-0.7||||0.0313|TWO_SIDED|95.0|-1.3|-0.1|||Mixed Effect Repeated Measures model|||"Week 10 CSD Total Score: 50 mg gefapixant vs. placebo~Week 10 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||-0.1|-1.3|0.0313
72592261|NCT02612610|144715450|OTHER||LS Mean Difference|-0.4||||0.2058|TWO_SIDED|95.0|-1.0|0.2|||Mixed Effect Repeated Measures model|||"Week 11 CSD Total Score: 7.5 mg gefapixant vs. placebo~Week 11 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.2|-1.0|0.2058
72592262|NCT02612610|144715450|OTHER||LS Mean Difference|-0.6||||0.0665|TWO_SIDED|95.0|-1.2|0.0|||Mixed Effect Repeated Measures model|||"Week 11 CSD Total Score: 20 mg gefapixant vs. placebo~Week 11 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.0|-1.2|0.0665
72592263|NCT02612610|144715450|OTHER||LS Mean Difference|-0.8||||0.0155|TWO_SIDED|95.0|-1.4|-0.1|||Mixed Effect Repeated Measures model|||"Week 11 CSD Total Score: 50 mg gefapixant vs. placebo~Week 11 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||-0.1|-1.4|0.0155
72592264|NCT02612610|144715451|OTHER||LS Mean Difference|-0.4||||0.2458|TWO_SIDED|95.0|-1.0|0.3|||Mixed Effect Repeated Measures model|||"Week 12 CSD Total Score: 7.5 mg gefapixant vs. placebo~Week 12 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.3|-1.0|0.2458
72592265|NCT02612610|144715451|OTHER||LS Mean Difference|-0.6||||0.0662|TWO_SIDED|95.0|-1.2|0.0|||Mixed Effect Repeated Measures model|||"Week 12 CSD Total Score: 20 mg gefapixant vs. placebo~Week 12 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.0|-1.2|0.0662
72592266|NCT02612610|144715451|OTHER||LS Mean Difference|-0.7||||0.0197|TWO_SIDED|95.0|-1.4|-0.1|||Mixed Effect Repeated Measures model|||"Week 12 CSD Total Score: 50 mg gefapixant vs. placebo~Week 12 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||-0.1|-1.4|0.0197
72592267|NCT02612610|144715452|OTHER||LS Mean Difference|0.3||||0.1921|TWO_SIDED|95.0|-0.2|0.8|||Mixed Effect Repeated Measures model|||"Week 1 DCS Total Score: 7.5 mg gefapixant vs. placebo~Week 1 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.8|-0.2|0.1921
72592268|NCT02612610|144715452|OTHER||LS Mean Difference|0.3||||0.2428|TWO_SIDED|95.0|-0.2|0.8|||Mixed Effect Repeated Measures model|||"Week 1 DCS Total Score: 20 mg gefapixant vs. placebo~Week 1 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.8|-0.2|0.2428
72592269|NCT02612610|144715452|OTHER||LS Mean Difference|-0.1||||0.7383|TWO_SIDED|95.0|-0.6|0.4|||Mixed Effect Repeated Measures model|||"Week 1 DCS Total Score: 50 mg gefapixant vs. placebo~Week 1 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.4|-0.6|0.7383
72414580|NCT01059565|144339310|SUPERIORITY_OR_OTHER||Difference in LSM|0.6||||0.762|TWO_SIDED|95.0|-3.3|4.49|||ANCOVA|The AUCs of changes from baseline were compared between treatment groups using ANCOVA methods with baseline value as a covariate.||Null hypothesis was that there was no difference between the AZLI and placebo treatment groups versus the alternative hypothesis that there was a difference.||4.49|-3.30|0.762
72592270|NCT02612610|144715453|OTHER||LS Mean Difference|0.3||||0.4033|TWO_SIDED|95.0|-0.4|0.9|||Mixed Effect Repeated Measures model|||"Week 2 DCS Total Score: 7.5 mg gefapixant vs. placebo~Week 2 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.9|-0.4|0.4033
72592271|NCT02612610|144715453|OTHER||LS Mean Difference|0.2||||0.4599|TWO_SIDED|95.0|-0.4|0.9|||Mixed Effect Repeated Measures model|||"Week 2 DCS Total Score: 20 mg gefapixant vs. placebo~Week 2 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.9|-0.4|0.4599
72592272|NCT02612610|144715453|OTHER||LS Mean Difference|-0.3||||0.2837|TWO_SIDED|95.0|-1.0|0.3|||Mixed Effect Repeated Measures model|||"Week 2 DCS Total Score: 50 mg gefapixant vs. placebo~Week 2 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.3|-1.0|0.2837
72592273|NCT02612610|144715454|OTHER||LS Mean Difference|0.1||||0.8084|TWO_SIDED|95.0|-0.6|0.8|||Mixed Effect Repeated Measures model|||"Week 3 DCS Total Score: 7.5 mg gefapixant vs. placebo~Week 3 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.8|-0.6|0.8084
72592274|NCT02612610|144715454|OTHER||LS Mean Difference|-0.2||||0.6108|TWO_SIDED|95.0|-0.8|0.5|||Mixed Effect Repeated Measures model|||"Week 3 DCS Total Score: 20 mg gefapixant vs. placebo~Week 3 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.5|-0.8|0.6108
72592275|NCT02612610|144715454|OTHER||LS Mean Difference|-0.3||||0.422|TWO_SIDED|95.0|-0.9|0.4|||Mixed Effect Repeated Measures model|||"Week 3 DCS Total Score: 50 mg gefapixant vs. placebo~Week 3 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.4|-0.9|0.4220
72592276|NCT02612610|144715455|OTHER||LS Mean Difference|-0.1||||0.8457|TWO_SIDED|95.0|-0.7|0.6|||Mixed Effect Repeated Measures model|||"Week 4 DCS Total Score: 7.5 mg gefapixant vs. placebo~Week 4 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.6|-0.7|0.8457
72414581|NCT01059565|144339311|SUPERIORITY_OR_OTHER||Difference in LSM|1.95||||0.553|TWO_SIDED|95.0|-4.54|8.44|||ANCOVA|The AUCs of changes from baseline were compared between treatment groups using ANCOVA methods with baseline value as a covariate.||Null hypothesis was that there was no difference between the AZLI and placebo treatment groups versus the alternative hypothesis that there was a difference.||8.44|-4.54|0.553
72592277|NCT02612610|144715455|OTHER||LS Mean Difference|-0.3||||0.4044|TWO_SIDED|95.0|-0.9|0.4|||Mixed Effect Repeated Measures model|||"Week 4 DCS Total Score: 20 mg gefapixant vs. placebo~Week 4 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.4|-0.9|0.4044
72592278|NCT02612610|144715455|OTHER||LS Mean Difference|-0.3||||0.3031|TWO_SIDED|95.0|-1.0|0.3|||Mixed Effect Repeated Measures model|||"Week 4 DCS Total Score: 50 mg gefapixant vs. placebo~Week 4 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.3|-1.0|0.3031
72592279|NCT02612610|144715456|OTHER||LS Mean Difference|0.0||||0.9126|TWO_SIDED|95.0|-0.7|0.6|||Mixed Effect Repeated Measures model|||"Week 5 DCS Total Score: 7.5 mg gefapixant vs. placebo~Week 5 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.6|-0.7|0.9126
72592280|NCT02612610|144715456|OTHER||LS Mean Difference|-0.5||||0.1136|TWO_SIDED|95.0|-1.2|0.1|||Mixed Effect Repeated Measures model|||"Week 5 DCS Total Score: 20 mg gefapixant vs. placebo~Week 5 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.1|-1.2|0.1136
72592281|NCT02612610|144715456|OTHER||LS Mean Difference|-0.7||||0.0352|TWO_SIDED|95.0|-1.4|0.0|||Mixed Effect Repeated Measures model|||"Week 5 DCS Total Score: 50 mg gefapixant vs. placebo~Week 5 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||-0.0|-1.4|0.0352
72592282|NCT02612610|144715457|OTHER||LS Mean Difference|-0.5||||0.1718|TWO_SIDED|95.0|-1.1|0.2|||Mixed Effect Repeated Measures model|||"Week 6 DCS Total Score: 7.5 mg gefapixant vs. placebo~Week 6 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.2|-1.1|0.1718
72592283|NCT02612610|144715457|OTHER||LS Mean Difference|-0.6||||0.0651|TWO_SIDED|95.0|-1.3|0.0|||Mixed Effect Repeated Measures model|||"Week 6 DCS Total Score: 20 mg gefapixant vs. placebo~Week 6 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.0|-1.3|0.0651
72592284|NCT02612610|144715457|OTHER||LS Mean Difference|-0.6||||0.0848|TWO_SIDED|95.0|-1.2|0.1|||Mixed Effect Repeated Measures model|||"Week 6 DCS Total Score: 50 mg gefapixant vs. placebo~Week 6 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.1|-1.2|0.0848
72414582|NCT01059565|144339312|SUPERIORITY_OR_OTHER||Difference in LSM|2.99||||0.17|TWO_SIDED|95.0|-1.2|7.28|||ANCOVA|Baseline was included as a covariate in this model.||Null hypothesis was that there was no difference between the AZLI and placebo treatment groups versus the alternative hypothesis that there was a difference.||7.28|-1.20|0.170
72414583|NCT01059565|144339313|SUPERIORITY_OR_OTHER||Difference in LSM|-2.57||||0.528|TWO_SIDED|95.0|-10.62|5.49|||ANCOVA|Baseline was included as a covariate in this model.||Null hypothesis was that there was no difference between the AZLI and placebo treatment groups versus the alternative hypothesis that there was a difference.||5.49|-10.62|0.528
72592285|NCT02612610|144715458|OTHER||LS Mean Difference|-0.1||||0.6715|TWO_SIDED|95.0|-0.8|0.5|||Mixed Effect Repeated Measures model|||"Week 7 DCS Total Score: 7.5 mg gefapixant vs. placebo~Week 7 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.5|-0.8|0.6715
72592286|NCT02612610|144715458|OTHER||LS Mean Difference|-0.3||||0.3514|TWO_SIDED|95.0|-1.0|0.4|||Mixed Effect Repeated Measures model|||"Week 7 DCS Total Score: 20 mg gefapixant vs. placebo~Week 7 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.4|-1.0|0.3514
72592287|NCT02612610|144715458|OTHER||LS Mean Difference|-0.4||||0.2809|TWO_SIDED|95.0|-1.1|0.3|||Mixed Effect Repeated Measures model|||"Week 7 DCS Total Score: 50 mg gefapixant vs. placebo~Week 7 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.3|-1.1|0.2809
72592288|NCT02612610|144715459|OTHER||LS Mean Difference|-0.2||||0.6022|TWO_SIDED|95.0|-0.9|0.5|||Mixed Effect Repeated Measures model|||"Week 8 DCS Total Score: 7.5 mg gefapixant vs. placebo~Week 8 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.5|-0.9|0.6022
72592289|NCT02612610|144715459|OTHER||LS Mean Difference|-0.3||||0.4456|TWO_SIDED|95.0|-1.0|0.4|||Mixed Effect Repeated Measures model|||"Week 8 DCS Total Score: 20 mg gefapixant vs. placebo~Week 8 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.4|-1.0|0.4456
72592290|NCT02612610|144715459|OTHER||LS Mean Difference|-0.3||||0.4629|TWO_SIDED|95.0|-1.0|0.4|||Mixed Effect Repeated Measures model|||"Week 8 DCS Total Score: 50 mg gefapixant vs. placebo~Week 8 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.4|-1.0|0.4629
72592291|NCT02612610|144715460|OTHER||LS Mean Difference|-0.3||||0.3749|TWO_SIDED|95.0|-1.0|0.4|||Mixed Effect Repeated Measures model|||"Week 9 DCS Total Score: 7.5 mg gefapixant vs. placebo~Week 9 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.4|-1.0|0.3749
72592292|NCT02612610|144715460|OTHER||LS Mean Difference|-0.6||||0.0854|TWO_SIDED|95.0|-1.3|0.1|||Mixed Effect Repeated Measures model|||"Week 9 DCS Total Score: 20 mg gefapixant vs. placebo~Week 9 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.1|-1.3|0.0854
72414584|NCT01059565|144339314|SUPERIORITY_OR_OTHER||Difference in LSM|3.62||||0.132|TWO_SIDED|95.0|-1.11|8.34|||ANCOVA|Baseline was included as a covariate in this model.||Null hypothesis was that there was no difference between the AZLI and placebo treatment groups versus the alternative hypothesis that there was a difference.||8.34|-1.11|0.132
72592293|NCT02612610|144715460|OTHER||LS Mean Difference|-0.4||||0.2672|TWO_SIDED|95.0|-1.1|0.3|||Mixed Effect Repeated Measures model|||"Week 9 DCS Total Score: 50 mg gefapixant vs. placebo~Week 9 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.3|-1.1|0.2672
72592294|NCT02612610|144715461|OTHER||LS Mean Difference|-0.1||||0.7255|TWO_SIDED|95.0|-0.8|0.6|||Mixed Effect Repeated Measures model|||"Week 10 DCS Total Score: 7.5 mg gefapixant vs. placebo~Week 10 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.6|-0.8|0.7255
72592295|NCT02612610|144715461|OTHER||LS Mean Difference|-0.6||||0.0918|TWO_SIDED|95.0|-1.3|0.1|||Mixed Effect Repeated Measures model|||"Week 10 DCS Total Score: 20 mg gefapixant vs. placebo~Week 10 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.1|-1.3|0.0918
72592296|NCT02612610|144715461|OTHER||LS Mean Difference|-0.5||||0.1263|TWO_SIDED|95.0|-1.2|0.2|||Mixed Effect Repeated Measures model|||"Week 10 DCS Total Score: 50 mg gefapixant vs. placebo~Week 10 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.2|-1.2|0.1263
72592297|NCT02612610|144715462|OTHER||LS Mean Difference|-0.3||||0.4058|TWO_SIDED|95.0|-1.0|0.4|||Mixed Effect Repeated Measures model|||"Week 11 DCS Total Score: 7.5 mg gefapixant vs. placebo~Week 11 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.4|-1.0|0.4058
72592298|NCT02612610|144715462|OTHER||LS Mean Difference|-0.6||||0.0828|TWO_SIDED|95.0|-1.3|0.1|||Mixed Effect Repeated Measures model|||"Week 11 DCS Total Score: 20 mg gefapixant vs. placebo~Week 11 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.1|-1.3|0.0828
72592299|NCT02612610|144715462|OTHER||LS Mean Difference|-0.7||||0.0575|TWO_SIDED|95.0|-1.4|0.0|||Mixed Effect Repeated Measures model|||"Week 11 DCS Total Score: 50 mg gefapixant vs. placebo~Week 11 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.0|-1.4|0.0575
72592300|NCT02612610|144715463|OTHER||LS Mean Difference|-0.3||||0.4163|TWO_SIDED|95.0|-1.0|0.4|||Mixed Effect Repeated Measures model|||"Week 12 DCS Total Score: 7.5 mg gefapixant vs. placebo~Week 12 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.4|-1.0|0.4163
72592301|NCT02612610|144715463|OTHER||LS Mean Difference|-0.6||||0.0882|TWO_SIDED|95.0|-1.3|0.1|||Mixed Effect Repeated Measures model|||"Week 12 DCS Total Score: 20 mg gefapixant vs. placebo~Week 12 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.1|-1.3|0.0882
72592302|NCT02612610|144715463|OTHER||LS Mean Difference|-0.6||||0.0961|TWO_SIDED|95.0|-1.4|0.1|||Mixed Effect Repeated Measures model|||"Week 12 DCS Total Score: 50 mg gefapixant vs. placebo~Week 12 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.1|-1.4|0.0961
72592303|NCT02612610|144715464|OTHER||LS Mean Difference|0.8||||0.163|TWO_SIDED|95.0|-0.3|1.9|||Mixed Effect Repeated Measures model|||"Day 28 LCQ Total Score: 7.5 mg gefapixant vs. placebo~Day 28 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||1.9|-0.3|0.1630
72592304|NCT02612610|144715464|OTHER||LS Mean Difference|0.2||||0.7601|TWO_SIDED|95.0|-1.0|1.3|||Mixed Effect Repeated Measures model|||"Day 28 LCQ Total Score: 20 mg gefapixant vs. placebo~Day 28 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||1.3|-1.0|0.7601
72592305|NCT02612610|144715464|OTHER||LS Mean Difference|2.1||||0.0004|TWO_SIDED|95.0|0.9|3.2|||Mixed Effect Repeated Measures model|||"Day 28 LCQ Total Score: 50 mg gefapixant vs. placebo~Day 28 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||3.2|0.9|0.0004
72592306|NCT02612610|144715465|OTHER||LS Mean Difference|1.0||||0.0941|TWO_SIDED|95.0|-0.2|2.3|||Mixed Effect Repeated Measures model|||"Day 56 LCQ Total Score: 7.5 mg gefapixant vs. placebo~Day 56 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||2.3|-0.2|0.0941
72592307|NCT02612610|144715465|OTHER||LS Mean Difference|0.9||||0.1321|TWO_SIDED|95.0|-0.3|2.2|||Mixed Effect Repeated Measures model|||"Day 56 LCQ Total Score: 20 mg gefapixant vs. placebo~Day 56 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||2.2|-0.3|0.1321
72592308|NCT02612610|144715465|OTHER||LS Mean Difference|1.5||||0.0192|TWO_SIDED|95.0|0.2|2.7|||Mixed Effect Repeated Measures model|||"Day 56 LCQ Total Score: 50 mg gefapixant vs. placebo~Day 56 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||2.7|0.2|0.0192
72592309|NCT02612610|144715466|OTHER||LS Mean Difference|1.2||||0.0626|TWO_SIDED|95.0|-0.1|2.4|||Mixed Effect Repeated Measures model|||"Day 85/Early Termination LCQ Total Score: 7.5 mg gefapixant vs. placebo~Day 85/Early Termination estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||2.4|-0.1|0.0626
72592310|NCT02612610|144715466|OTHER||LS Mean Difference|1.0||||0.0967|TWO_SIDED|95.0|-0.2|2.3|||Mixed Effect Repeated Measures model|||"Day 85/Early Termination LCQ Total Score: 20 mg gefapixant vs. placebo~Day 85/Early Termination estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||2.3|-0.2|0.0967
72592311|NCT02612610|144715466|OTHER||LS Mean Difference|1.9||||0.0028|TWO_SIDED|95.0|0.7|3.1|||Mixed Effect Repeated Measures model|||"Day 85/Early Termination LCQ Total Score: 50 mg gefapixant vs. placebo~Day 85/Early Termination estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||3.1|0.7|0.0028
72592312|NCT02612610|144715467|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3182|||||||Cochran-Mantel-Haenszel|||"Day 28 PGIC: 7.5 mg gefapixant vs. placebo~The distribution of responses were compared between each of the gefapixant treatment groups and placebo using the stratified CMH test (stratified by country). P-values calculated using CMH test."||||0.3182
72592313|NCT02612610|144715467|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5021|||||||Cochran-Mantel-Haenszel|||"Day 28 PGIC: 20 mg gefapixant vs. placebo~The distribution of responses were compared between each of the gefapixant treatment groups and placebo using the stratified CMH test (stratified by country). P-values calculated using CMH test."||||0.5021
72592314|NCT02612610|144715467|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0665|||||||Cochran-Mantel-Haenszel|||"Day 28 PGIC: 50 mg gefapixant vs. placebo~The distribution of responses were compared between each of the gefapixant treatment groups and placebo using the stratified CMH test (stratified by country). P-values calculated using CMH test."||||0.0665
72592315|NCT02612610|144715468|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0872|||||||Cochran-Mantel-Haenszel|||"Day 56 PGIC: 7.5 mg gefapixant vs. placebo~The distribution of responses were compared between each of the gefapixant treatment groups and placebo using the stratified CMH test (stratified by country). P-values calculated using CMH test."||||0.0872
72592316|NCT02612610|144715468|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0994|||||||Cochran-Mantel-Haenszel|||"Day 56 PGIC: 20 mg gefapixant vs. placebo~The distribution of responses were compared between each of the gefapixant treatment groups and placebo using the stratified CMH test (stratified by country). P-values calculated using CMH test."||||0.0994
72592317|NCT02612610|144715468|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0009|||||||Cochran-Mantel-Haenszel|||"Day 56 PGIC: 50 mg gefapixant vs. placebo~The distribution of responses were compared between each of the gefapixant treatment groups and placebo using the stratified CMH test (stratified by country). P-values calculated using CMH test."||||0.0009
72592318|NCT02612610|144715469|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0037|||||||Cochran-Mantel-Haenszel|||"Day 85/Early Termination PGIC: 7.5 mg gefapixant vs. placebo~The distribution of responses were compared between each of the gefapixant treatment groups and placebo using the stratified CMH test (stratified by country). P-values calculated using CMH test."||||0.0037
72592319|NCT02612610|144715469|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0166|||||||Cochran-Mantel-Haenszel|||"Day 85/Early Termination PGIC: 20 mg gefapixant vs. placebo~The distribution of responses were compared between each of the gefapixant treatment groups and placebo using the stratified CMH test (stratified by country). P-values calculated using CMH test."||||0.0166
72592320|NCT02612610|144715469|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||"Day 85/Early Termination: 50 mg gefapixant vs. placebo~The distribution of responses were compared between each of the gefapixant treatment groups and placebo using the stratified CMH test (stratified by country). P-values calculated using CMH test."||||<0.0001
72592321|NCT02612610|144715470|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0396|||||||Cochran-Mantel-Haenszel|||"Day 85/Early Termination CGIC: 7.5 mg gefapixant vs. placebo~The distribution of responses were compared between each of the gefapixant treatment groups and placebo using the stratified CMH test (stratified by country). P-values calculated using CMH test."||||0.0396
72592322|NCT02612610|144715470|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0751|||||||Cochran-Mantel-Haenszel|||"Day 85/Early Termination CGIC: 20 mg gefapixant vs. placebo~The distribution of responses were compared between each of the gefapixant treatment groups and placebo using the stratified CMH test (stratified by country). P-values calculated using CMH test."||||0.0751
72592323|NCT02612610|144715470|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|||||||Cochran-Mantel-Haenszel|||"Day 85/Early Termination CGIC: 50 mg gefapixant vs. placebo~The distribution of responses were compared between each of the gefapixant treatment groups and placebo using the stratified CMH test (stratified by country). P-values calculated using CMH test."||||0.0010
72592324|NCT02612610|144715471|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8464|||||||Cochran-Mantel-Haenszel|||"1 Year Acceptability: 7.5 mg gefapixant vs. placebo~The distribution of Extremely likely responses was compared between each of the gefapixant treatment groups and placebo using the stratified CMH test (stratified by country). P-values calculated for the gefapixant vs. placebo using CMH test."||||0.8464
72414585|NCT01059565|144339315|SUPERIORITY_OR_OTHER||Difference in LSM|0.14||||0.531|TWO_SIDED|95.0|-0.29|0.56|||Mixed Models Analysis|P-value was based on a Mixed-Effect Model Repeated Measure model that included terms for treatment, visit, baseline, and treatment/visit interaction.||Null hypothesis was that there was no difference between the AZLI and placebo treatment groups versus the alternative hypothesis that there was a difference.||0.56|-0.29|0.531
72592325|NCT02612610|144715471|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7687|||||||Cochran-Mantel-Haenszel|||"1 Year Acceptability: 20 mg gefapixant vs. placebo~The distribution of Extremely likely responses was compared between each of the gefapixant treatment groups and placebo using the stratified CMH test (stratified by country). P-values calculated for gefapixant vs. placebo using CMH test."||||0.7687
72592326|NCT02612610|144715471|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4364|||||||Cochran-Mantel-Haenszel|||"1 Year Acceptability: 50 mg gefapixant vs. placebo~The distribution of Extremely likely responses was compared between each of the gefapixant treatment groups and placebo using the stratified CMH test (stratified by country). P-values calculated for gefapixant vs. placebo using CMH test."||||0.4364
72592327|NCT02612610|144715472|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9966|||||||Cochran-Mantel-Haenszel|||"6 Month Acceptability: 7.5 mg gefapixant vs. placebo~The distribution of Extremely likely responses were compared between each of the gefapixant treatment groups and placebo using the stratified CMH test (stratified by country). P-values calculated for gefapixant vs. placebo using CMH test."||||0.9966
72592328|NCT02612610|144715472|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6372|||||||Cochran-Mantel-Haenszel|||"6 Month Acceptability: 20 mg gefapixant vs. placebo~The distribution of Extremely likely responses were compared between each of the gefapixant treatment groups and placebo using the stratified CMH test (stratified by country). P-values calculated for gefapixant vs. placebo using CMH test."||||0.6372
72592329|NCT02612610|144715472|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2155|||||||Cochran-Mantel-Haenszel|||"6 Month Acceptability: 50 mg gefapixant vs. placebo~The distribution of Extremely likely responses were compared between each of the gefapixant treatment groups and placebo using the stratified CMH test (stratified by country). P-values calculated for gefapixant vs. placebo using CMH test."||||0.2155
72592330|NCT02612610|144715473|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7559|||||||Cochran-Mantel-Haenszel|||"4 Week Acceptability: 7.5 mg gefapixant vs. placebo~The distribution of Extremely likely responses were compared between each of the gefapixant treatment groups and placebo using the stratified CMH test (stratified by country). P-values calculated for gefapixant vs. placebo using CMH test."||||0.7559
72592331|NCT02612610|144715473|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5091|||||||Cochran-Mantel-Haenszel|||"4 Week Acceptability: 20 mg gefapixant vs. placebo~The distribution of Extremely likely responses were compared between each of the gefapixant treatment groups and placebo using the stratified CMH test (stratified by country). P-values calculated for gefapixant vs. placebo using CMH test."||||0.5091
72414586|NCT01059565|144339316|SUPERIORITY_OR_OTHER||Difference in LSM|0.93||||0.232|TWO_SIDED|95.0|-0.62|2.48|||ANCOVA|Baseline was included as a covariate in this model.||Null hypothesis was that there was no difference between the AZLI and placebo treatment groups versus the alternative hypothesis that there was a difference.||2.48|-0.62|0.232
72414587|NCT01059565|144339317|SUPERIORITY_OR_OTHER|||||||0.103|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis was that there was no difference between the AZLI and placebo treatment groups versus the alternative hypothesis that there was a difference.||||0.103
72592332|NCT02612610|144715473|SUPERIORITY_OR_OTHER_LEGACY|||||||0.279|||||||Cochran-Mantel-Haenszel|||"4 Week Acceptability: 50 mg gefapixant vs. placebo~The distribution of Extremely likely responses were compared between each of the gefapixant treatment groups and placebo using the stratified CMH test (stratified by country). P-values calculated for gefapixant vs. placebo using CMH test."||||0.2790
72592333|NCT02612610|144715474|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3887|||||||Cochran-Mantel-Haenszel|||"Twice Daily Acceptability: 7.5 mg gefapixant vs. placebo~The distribution of Extremely likely responses were compared between each of the gefapixant treatment groups and placebo using the stratified CMH test (stratified by country). P-values calculated for gefapixant vs. placebo using CMH test."||||0.3887
72592334|NCT02612610|144715474|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2333|||||||Cochran-Mantel-Haenszel|||"Twice Daily Acceptability: 20 mg gefapixant vs. placebo~The distribution of Extremely likely responses were compared between each of the gefapixant treatment groups and placebo using the stratified CMH test (stratified by country). P-values calculated for gefapixant vs. placebo using CMH test."||||0.2333
72592335|NCT02612610|144715474|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0534|||||||Cochran-Mantel-Haenszel|||"Twice Daily Acceptability: 50 mg gefapixant vs. placebo~The distribution of Extremely likely responses were compared between each of the gefapixant treatment groups and placebo using the stratified CMH test (stratified by country). P-values calculated for gefapixant vs. placebo using CMH test."||||0.0534
72414588|NCT01059565|144339318|SUPERIORITY_OR_OTHER|||||||0.646|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis was that there was no difference between the AZLI and placebo treatment groups versus the alternative hypothesis that there was a difference.||||0.646
72592336|NCT02612610|144715475|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6115|||||||Cochran-Mantel-Haenszel|||"Taste Effect Frequency: 7.5 mg gefapixant vs. placebo~The distribution of No Taste Effect Noted or Never responses were compared between each of the gefapixant treatment groups and placebo using the stratified CMH test (stratified by country). P-values calculated for gefapixant vs. placebo using CMH test."||||0.6115
72414589|NCT01059565|144339319|SUPERIORITY_OR_OTHER|||||||0.284|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis was that there was no difference between the AZLI and placebo treatment groups versus the alternative hypothesis that there was a difference.||||0.284
72414590|NCT00574587|144339321|SUPERIORITY_OR_OTHER_LEGACY||95% Confidence interval|54.0|||<|0.1|TWO_SIDED|20.0|34.0|74.0|||Simon's Mimimax 2-stage design|||||74|34|<0.10
72421552|NCT01264380|144354235|SUPERIORITY_OR_OTHER||Ratio of Geometric Mean|5.05|||||TWO_SIDED|90.0|2.99|8.55||||||The point estimate and 90% CI of vemurafenib plasma AUC geometric means ratios of the Fed to Fasted conditions following an oral administration of a single dose of 960 mg vemurafenib were analyzed.||8.55|2.99|
72592337|NCT02612610|144715475|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||"Taste Effect Frequency: 20 mg gefapixant vs. placebo~The distribution of No Taste Effect Noted or Never responses were compared between each of the gefapixant treatment groups and placebo using the stratified CMH test (stratified by country). P-values calculated for gefapixant vs. placebo using CMH test."||||<0.0001
72592338|NCT02612610|144715475|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||"Taste Effect Frequency: 50 mg gefapixant vs. placebo~The distribution of No Taste Effect Noted or Never responses were compared between each of the gefapixant treatment groups and placebo using the stratified CMH test (stratified by country). P-values calculated for gefapixant vs. placebo using CMH test."||||<0.0001
72592339|NCT02612610|144715476|SUPERIORITY_OR_OTHER_LEGACY|||||||0||||||"A p-value of zero was calculated if all participants (100%) had No Taste Effect Noted or Not at All responses in both comparison groups."|Cochran-Mantel-Haenszel|||"Taste Effect Frequency: 7.5 mg gefapixant vs. placebo~The distribution of No Taste Effect Noted or Not at All responses were compared between each of the gefapixant treatment groups and placebo using the stratified CMH test (stratified by country). P-values calculated for gefapixant vs. placebo using CMH test."||||0
72592340|NCT02612610|144715476|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||"Taste Effect Frequency: 20 mg gefapixant vs. placebo~The distribution of No Taste Effect Noted or Not at All responses were compared between each of the gefapixant treatment groups and placebo using the stratified CMH test (stratified by country). P-values calculated for gefapixant vs. placebo using CMH test."||||<0.0001
72592341|NCT02612610|144715476|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||"Taste Effect Frequency: 50 mg gefapixant vs. placebo~The distribution of No Taste Effect Noted or Not at All responses were compared between each of the gefapixant treatment groups and placebo using the stratified CMH test (stratified by country). P-values calculated for gefapixant vs. placebo using CMH test."||||<0.0001
72592342|NCT05127304|144715483|OTHER|||||||0.639|||||||Weighted clustered linear regression|||Ambulatory visits||||0.639
72592343|NCT05127304|144715483|OTHER|||||||0.535|||||||Weighted clustered linear regression|||Office visits||||0.535
72592344|NCT05127304|144715483|OTHER|||||||0.337|||||||Weighted clustered linear regression|||Outpatient visits||||0.337
72592345|NCT05127304|144715483|OTHER|||||||0.058|||||||Weighted clustered linear regression|||Emergency room visits||||0.058
72592346|NCT05127304|144715483|OTHER|||||||0.192|||||||Weighted clustered linear regression|||Inpatient visits||||0.192
72592347|NCT05127304|144715483|OTHER|||||||0.176|||||||Weighted clustered linear regression|||Other medical visits||||0.176
72592348|NCT05127304|144715484|OTHER|||||||0.313|||||||Weighted clustered linear regression|||||||0.313
72592349|NCT05127304|144715485|OTHER|||||||0.021|||||||Weighted clustered linear regression|||||||0.021
72592350|NCT05127304|144715486|OTHER|||||||0.022|||||||Weighted clustered linear regression|||Ambulatory visits||||0.022
72592351|NCT05127304|144715486|OTHER|||||||0.124|||||||Weighted clustered linear regression|||Office visits||||0.124
72592352|NCT05127304|144715486|OTHER|||||||0.043|||||||Weighted clustered linear regression|||Outpatient visits||||0.043
72592353|NCT05127304|144715486|OTHER|||||||0.99|||||||Weighted clustered linear regression|||Emergency room visits||||0.990
72592354|NCT05127304|144715486|OTHER|||||||0.039|||||||Weighted clustered linear regression|||Inpatient visits||||0.039
72592355|NCT05127304|144715486|OTHER||||||<|0.001|||||||Weighted clustered linear regression|||Other medical visits||||<0.001
72592356|NCT05127304|144715487|OTHER|||||||0.163|||||||Weighted clustered linear regression|||||||0.163
72592357|NCT05127304|144715488|OTHER|||||||0.037|||||||Weighted clustered linear regression|||||||0.037
72414591|NCT02647359|144339350|OTHER||Least Square (LS) Mean Difference|10.76||||0.4868|TWO_SIDED|95.0|-21.914|43.434||Threshold for significance at 0.05 level.|ANCOVA|||Analysis was performed using analysis of covariance (ANCOVA) with age and baseline Maximum Reading Speed (both eyes) as covariates, and treatment as a factor.||43.434|-21.914|0.4868
72414592|NCT04818346|144339371|SUPERIORITY||Least squares mean difference|-21.41|STANDARD_ERROR_OF_MEAN|6.62||0.0015|TWO_SIDED|95.0|-34.49|-8.32|||Mixed Model Repeated Measures (MMRM)|||||-8.32|-34.49|0.0015
72592358|NCT05127304|144715489|OTHER|||||||0.017|||||||Weighted clustered linear regression|||Ambulatory visits||||0.017
72592359|NCT05127304|144715489|OTHER|||||||0.098|||||||Weighted clustered linear regression|||Office visits||||0.098
72592360|NCT05127304|144715489|OTHER|||||||0.036|||||||Weighted clustered linear regression|||Outpatient visits||||0.036
72592361|NCT05127304|144715489|OTHER|||||||0.894|||||||Weighted clustered linear regression|||Emergency room visits||||0.894
72592362|NCT05127304|144715489|OTHER|||||||0.036|||||||Weighted clustered linear regression|||Inpatient visits||||0.036
72414593|NCT04818346|144339371|SUPERIORITY||Least squares mean difference|-20.07|STANDARD_ERROR_OF_MEAN|6.86||0.004|TWO_SIDED|95.0|-33.63|-6.51|||MMRM|||||-6.51|-33.63|0.0040
72592363|NCT05127304|144715489|OTHER|||||||0.001|||||||Weighted clustered linear regression|||Other medical visits||||0.001
72592364|NCT05127304|144715490|OTHER|||||||0.162|||||||Weighted clustered linear regression|||||||0.162
72592365|NCT05127304|144715491|OTHER|||||||0.037|||||||Weighted clustered linear regression|||||||0.037
72592366|NCT05127304|144715492|OTHER|||||||0.065|||||||Weighted clustered linear regression|||Ambulatory visits||||0.065
72592367|NCT05127304|144715492|OTHER|||||||0.102|||||||Weighted clustered linear regression|||Office visits||||0.102
72592368|NCT05127304|144715492|OTHER|||||||0.1|||||||Weighted clustered linear regression|||Outpatient visits||||0.100
72592369|NCT05127304|144715492|OTHER|||||||0.189|||||||Weighted clustered linear regression|||Emergency room visits||||0.189
72592370|NCT05127304|144715492|OTHER|||||||0.024|||||||Weighted clustered linear regression|||Inpatient visits||||0.024
72592371|NCT05127304|144715492|OTHER|||||||0.767|||||||Weighted clustered linear regression|||Other medical visits||||0.767
72592372|NCT05127304|144715493|OTHER|||||||0.357|||||||Weighted clustered linear regression|||||||0.357
72592373|NCT05127304|144715494|OTHER|||||||0.002|||||||Weighted clustered linear regression|||Ambulatory visits||||0.002
72592374|NCT05127304|144715494|OTHER|||||||0.42|||||||Weighted clustered linear regression|||Office visits||||0.420
72592375|NCT05127304|144715494|OTHER|||||||0.002|||||||Weighted clustered linear regression|||Outpatient visits||||0.002
72592376|NCT05127304|144715494|OTHER|||||||0.304|||||||Weighted clustered linear regression|||Emergency room visits||||0.304
72414594|NCT04818346|144339371|SUPERIORITY||Least squares mean difference|-18.02|STANDARD_ERROR_OF_MEAN|6.77||0.0086|TWO_SIDED|95.0|-31.4|-4.64|||MMRM|||||-4.64|-31.40|0.0086
72592377|NCT05127304|144715494|OTHER|||||||0.326|||||||Weighted clustered linear regression|||Inpatient visits||||0.326
72592378|NCT05127304|144715494|OTHER|||||||0.007|||||||Weighted clustered linear regression|||Other medical visits||||0.007
72592379|NCT05127304|144715495|OTHER|||||||0.52|||||||Weighted clustered linear regression|||||||0.520
72592380|NCT05127304|144715496|OTHER|||||||0.037|||||||Weighted clustered linear regression|||||||0.037
72592381|NCT05127304|144715497|OTHER|||||||0.06|||||||Weighted clustered linear regression|||Medical costs||||0.060
72592382|NCT05127304|144715497|OTHER|||||||0.177|||||||Weighted clustered linear regression|||Ambulatory costs||||0.177
72592383|NCT05127304|144715497|OTHER|||||||0.834|||||||Weighted clustered linear regression|||Office visits costs||||0.834
72592384|NCT05127304|144715497|OTHER|||||||0.121|||||||Weighted clustered linear regression|||Outpatient visits costs||||0.121
72592385|NCT05127304|144715497|OTHER|||||||0.159|||||||Weighted clustered linear regression|||Emergency room visits costs||||0.159
72592386|NCT05127304|144715497|OTHER|||||||0.289|||||||Weighted clustered linear regression|||Inpatient stay costs||||0.289
72592387|NCT05127304|144715497|OTHER|||||||0.055|||||||Weighted clustered linear regression|||Other medical costs||||0.055
72592388|NCT05127304|144715497|OTHER||||||<|0.001|||||||Weighted clustered linear regression|||Pharmacy costs||||<0.001
72592389|NCT05127304|144715497|OTHER||||||<|0.001|||||||Weighted clustered linear regression|||Total (medical + pharmacy) costs||||<0.001
72592390|NCT05127304|144715498|OTHER|||||||0.066|||||||Weighted clustered linear regression|||Medical costs||||0.066
72592391|NCT05127304|144715498|OTHER|||||||0.193|||||||Weighted clustered linear regression|||Ambulatory costs||||0.193
72592392|NCT05127304|144715498|OTHER|||||||0.117|||||||Weighted clustered linear regression|||Office visits costs||||0.117
72592393|NCT05127304|144715498|OTHER|||||||0.25|||||||Weighted clustered linear regression|||Outpatient visits costs||||0.250
72592394|NCT05127304|144715498|OTHER|||||||0.431|||||||Weighted clustered linear regression|||Emergency room visits costs||||0.431
72592395|NCT05127304|144715498|OTHER|||||||0.129|||||||Weighted clustered linear regression|||Inpatient stay costs||||0.129
72592396|NCT05127304|144715498|OTHER|||||||0.236|||||||Weighted clustered linear regression|||Other medical costs||||0.236
72592397|NCT05127304|144715498|OTHER||||||<|0.001|||||||Weighted clustered linear regression|||Pharmacy costs||||<0.001
72592398|NCT05127304|144715498|OTHER||||||<|0.001|||||||Weighted clustered linear regression|||Total (medical + pharmacy) costs||||<0.001
72592399|NCT05127304|144715499|OTHER|||||||0.057|||||||Weighted clustered linear regression|||Medical costs||||0.057
72592400|NCT05127304|144715499|OTHER|||||||0.182|||||||Weighted clustered linear regression|||Ambulatory costs||||0.182
72592401|NCT05127304|144715499|OTHER|||||||0.083|||||||Weighted clustered linear regression|||Office visits costs||||0.083
72592402|NCT05127304|144715499|OTHER|||||||0.245|||||||Weighted clustered linear regression|||Outpatient visits costs||||0.245
72592403|NCT05127304|144715499|OTHER|||||||0.386|||||||Weighted clustered linear regression|||Emergency room visits costs||||0.386
72592404|NCT05127304|144715499|OTHER|||||||0.115|||||||Weighted clustered linear regression|||Inpatient stay costs||||0.115
72592405|NCT05127304|144715499|OTHER|||||||0.237|||||||Weighted clustered linear regression|||Other medical costs||||0.237
72592406|NCT05127304|144715499|OTHER||||||<|0.001|||||||Weighted clustered linear regression|||Pharmacy costs||||<0.001
72592407|NCT05127304|144715499|OTHER||||||<|0.001|||||||Weighted clustered linear regression|||Total (medical + pharmacy) costs||||<0.001
72592408|NCT05127304|144715500|OTHER|||||||0.189|||||||Weighted clustered linear regression|||Medical costs||||0.189
72592409|NCT05127304|144715500|OTHER|||||||0.314|||||||Weighted clustered linear regression|||Ambulatory costs||||0.314
72592410|NCT05127304|144715500|OTHER|||||||0.203|||||||Weighted clustered linear regression|||Office visits costs||||0.203
72592411|NCT05127304|144715500|OTHER|||||||0.379|||||||Weighted clustered linear regression|||Outpatient visits costs||||0.379
72414595|NCT04818346|144339372|SUPERIORITY||Odds Ratio (OR)|4.3||||0.3574|TWO_SIDED|95.0|0.398|220.998|||Wald test||Logistic regression: (response at Week 24 = treatment + stratification factor \[T-BSA involvement 8%-20%/\>20%\]).|||220.998|0.398|0.3574
72592412|NCT05127304|144715500|OTHER|||||||0.815|||||||Weighted clustered linear regression|||Emergency room visits costs||||0.815
72592413|NCT05127304|144715500|OTHER|||||||0.205|||||||Weighted clustered linear regression|||Inpatient stay costs||||0.205
72592414|NCT05127304|144715500|OTHER|||||||0.556|||||||Weighted clustered linear regression|||Other medical costs||||0.556
72592415|NCT05127304|144715500|OTHER|||||||0.189|||||||Weighted clustered linear regression|||Total (medical + pharmacy) costs||||0.189
72592416|NCT05127304|144715501|OTHER|||||||0.483|||||||Weighted clustered linear regression|||Medical costs||||0.483
72592417|NCT05127304|144715501|OTHER|||||||0.002|||||||Weighted clustered linear regression|||Ambulatory costs||||0.002
72592418|NCT05127304|144715501|OTHER|||||||0.123|||||||Weighted clustered linear regression|||Office visits costs||||0.123
72592419|NCT05127304|144715501|OTHER|||||||0.003|||||||Weighted clustered linear regression|||Outpatient visits costs||||0.003
72592420|NCT05127304|144715501|OTHER|||||||0.17|||||||Weighted clustered linear regression|||Emergency room visits costs||||0.170
72592421|NCT05127304|144715501|OTHER|||||||0.582|||||||Weighted clustered linear regression|||Inpatient stay costs||||0.582
72592422|NCT05127304|144715501|OTHER|||||||0.887|||||||Weighted clustered linear regression|||Other medical costs||||0.887
72414596|NCT04818346|144339372|SUPERIORITY||Odds Ratio (OR)|5.5||||0.1992|TWO_SIDED|95.0|0.573|273.479|||Wald test||Logistic regression: (response at Week 24 = treatment + stratification factor \[T-BSA involvement 8%-20%/\>20%\]).|||273.479|0.573|0.1992
72592423|NCT05127304|144715501|OTHER||||||<|0.001|||||||Weighted clustered linear regression|||Pharmacy costs||||<0.001
72592424|NCT05127304|144715501|OTHER||||||<|0.001|||||||Weighted clustered linear regression|||Total (medical + pharmacy) costs||||<0.001
72592425|NCT05127304|144715502|OTHER|||||||0.205|||||||Weighted clustered linear regression|||Any COPD exacerbation||||0.205
72592426|NCT05127304|144715502|OTHER|||||||0.454|||||||Weighted clustered linear regression|||Severe COPD exacerbation||||0.454
72592427|NCT05127304|144715503|OTHER|||||||0.06|||||||Rao-Scott test|||||||0.060
72592428|NCT01323010|144715532|SUPERIORITY_OR_OTHER|||||||0.689|TWO_SIDED||||||Chi-squared|||||||0.689
72592429|NCT01323010|144715533|SUPERIORITY_OR_OTHER|||||||0.591|TWO_SIDED||||||t-test, 2 sided|||||||0.591
72592430|NCT01323010|144715534|SUPERIORITY_OR_OTHER|||||||0.15|TWO_SIDED||||||ANOVA|Method: ANOVA with repetead measures for non parametric data proposed by Brunner and Piri.||||||0.150
72592431|NCT01323010|144715535|SUPERIORITY_OR_OTHER|||||||0.042|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.042
72592432|NCT01323010|144715536|SUPERIORITY_OR_OTHER|||||||0.108|TWO_SIDED||||||ANOVA|||||||0.108
72592433|NCT01323010|144715538|SUPERIORITY_OR_OTHER|||||||0.122|TWO_SIDED||||||ANOVA|||||||0.122
72592434|NCT01323010|144715540|SUPERIORITY_OR_OTHER|||||||0.164|TWO_SIDED||||||ANOVA|Method: ANOVA with repetead measures for non paramteric data proposed by Brunner and Piri.||||||0.164
72592435|NCT01323010|144715541|SUPERIORITY_OR_OTHER|||||||0.165|TWO_SIDED||||||ANOVA|||||||0.165
72592436|NCT01323010|144715542|SUPERIORITY_OR_OTHER|||||||0.436|TWO_SIDED||||||ANOVA|||||||0.436
72592437|NCT01323010|144715543|SUPERIORITY_OR_OTHER|||||||0.046|TWO_SIDED||||||ANOVA|||||||0.046
72592438|NCT01323010|144715544|SUPERIORITY_OR_OTHER|||||||0.723|TWO_SIDED||||||ANOVA|||||||0.723
72592439|NCT01323010|144715545|SUPERIORITY_OR_OTHER|||||||0.235|TWO_SIDED||||||ANOVA|||||||0.235
72592440|NCT01323010|144715546|SUPERIORITY_OR_OTHER|||||||0.284|TWO_SIDED||||||ANOVA|||||||0.284
72592441|NCT01323010|144715547|SUPERIORITY_OR_OTHER|||||||0.905|TWO_SIDED||||||ANOVA|||||||0.905
72592442|NCT01323010|144715550|SUPERIORITY_OR_OTHER|||||||0.892|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.892
72592443|NCT01323010|144715551|SUPERIORITY_OR_OTHER|||||||0.195|TWO_SIDED||||||Chi-squared|||||||0.195
72592444|NCT01323010|144715552|SUPERIORITY_OR_OTHER|||||||0.203|TWO_SIDED||||||Chi-squared, Corrected|||||||0.203
72592445|NCT01323010|144715553|SUPERIORITY_OR_OTHER|||||||0.03|TWO_SIDED||||||Chi-squared|||||||0.03
72592446|NCT05174949|144715566|SUPERIORITY|We performed a linear regression analysis (generalized estimating equations) in which we compared both intervention groups to the sham group and added a time interaction term|Mean Difference (Final Values)|5.4|STANDARD_DEVIATION|3.58|<|0.0001|TWO_SIDED|95.0|2.4|8.4||Anode compared to sham: p = 0.0516 Cathode compared to sham: p \<.0001 . Anode change over time compared to sham p=0.0255 Cathode change over time compared to sham p\<.0001|Generalized Estimating Equations||Anode mean change = 4.13 std = 4.29 CLM = 0.5-7.7 Cathode mean change = 5.38 std = 3.58 CLM=2.4-8.4|We will report first anode compared to sham and then cathode compared to sham||8.4|2.4|<0.0001
72592447|NCT05174949|144715567|SUPERIORITY||Mean Difference (Final Values)|-24.2|STANDARD_DEVIATION|9.5||0.002|TWO_SIDED|95.0|-32.2|-16.2||anode compared to sham p= 0.0020 cathode compared to sham p = 0.0088 anode over time anode compared to sham p \<.0001 Cathode over time compared to sham p \<.0001|Regression, Cox||anode -24.2 (-32.2, -16.2) cathode -22.2 (-30.6, -13.8)|We compared anode to sham We compared cathode to sham We compared the change over time of anode to sham We compared the change over time of cathode to shal||-16.2|-32.2|0.0020
72592448|NCT05174949|144715568|SUPERIORITY||Mean Difference (Final Values)|0.077||||0.0001|TWO_SIDED|95.0|0.0|0.1||Compare anode to sham p= 0.0001 Compare cathode to sham p=0.1073 Compare anode change in time to sham p=0.0938 Compare cathode change in time to sham 0.0068|Regression, Linear|Using generalized estimating equations with group and time component|Anode = 0.077 (0.00, 0.10) Cathode = -.0.125 (-0.32 0.07 )|e compare anode to sham We compare cathode to sham||0.10|0.00|0.0001
72592449|NCT02951533|144715569|SUPERIORITY||||||<|0.0001|||||||Chi-squared|||||||<0.0001
72414597|NCT04818346|144339372|SUPERIORITY||Odds Ratio (OR)|2.1||||0.9913|TWO_SIDED|95.0|0.103|126.386|||Wald test||Logistic regression: (response at Week 24 = treatment + stratification factor \[T-BSA involvement 8%-20%/\>20%\]).|||126.386|0.103|0.9913
72592450|NCT01623037|144715615|OTHER||sucess proportion|71.1|||||TWO_SIDED|95.0|55.7|83.6||||||||83.6|55.7|
72592451|NCT01203826|144715620|OTHER|||||||0.0005|||||||Wilcoxon signed-rank test|P-value based on Wilcoxon signed-rank test.||Change is relative to Baseline in Study ENB-006-09 (NCT00952484). The RGI-C score represents evaluations of skeletal X-rays at each post-treatment study timepoint in Study ENB-008-10 compared with pre-treatment X-rays from Study ENB-006-09, using an ordinal scale. Therefore, no Baseline data for RGI-C are available.||||0.0005
72592452|NCT04464720|144715681|OTHER|||||||0.05|||||||Wilcoxon Ranked Sum|||comparing pre and post intervention PM2.5||||0.050
72592453|NCT04464720|144715684|OTHER|||||||0.043|||||||Wilcoxon Ranked Sum|||comparing pre v post intervention NO2||||0.043
72592454|NCT04464720|144715687|OTHER|||||||0.056|||||||Wilcoxon Ranked Sum|||comparing FVC pre and post intervention||||0.056
72592455|NCT04464720|144715688|OTHER|||||||0.058|||||||Wilcoxon Signed Rank|||Comparing FEV1 pre and post intervention||||0.058
72592456|NCT04464720|144715690|OTHER|||||||0.058|||||||Wilcoxon Ranked Sum|||comparing FeNO pre v post intervention||||0.058
72592457|NCT05537792|144715699|OTHER|Paired t-tests were used to compare the offline forward estimation error of each adapted forward estimator with the baseline during overground walking.||||||0.579|||||||t-test, 1 sided|||||||0.579
72592458|NCT05537792|144715699|OTHER|Paired t-tests were used to compare the offline forward estimation error of each adapted forward estimator with the baseline during overground walking.||||||0.0008|||||||t-test, 1 sided|||||||0.0008
72592459|NCT05537792|144715699|OTHER|Paired t-tests were used to compare the offline forward estimation error of each adapted forward estimator with the baseline during overground walking.||||||0.5513|||||||t-test, 1 sided|||||||0.5513
72592460|NCT05537792|144715699|OTHER|Paired t-tests were used to compare the offline forward estimation error of each adapted forward estimator with the baseline during overground walking.||||||0.00034|||||||t-test, 1 sided|||||||0.00034
72592461|NCT03495154|144715707|OTHER|This was not a comparative endpoint.|Percentage and confidence interval|3.3|||||TWO_SIDED|95.0|1.0|8.5||||||Number of participants with hernia recurrence within 12 months following Parietene™ DS Composite Mesh use in ventral hernia repair||8.5|1.0|
72592462|NCT03495154|144715708|OTHER|Statistical Analysis is based on number of participants with incidence of with ADEs at discharge. Adverse Device Effects (ADE) is inclusive of both procedure and/or device related AEs.|Number of Subjects with ADEs|14.0|||||TWO_SIDED|||||||||||||
72592463|NCT03495154|144715708|OTHER|Statistical Analysis is based on number of participants with incidence of ADEs within 1 month. Adverse Device Effects (ADE) is inclusive of both procedure and/or device related AEs.|Number of Subjects with ADEs|31.0|||||TWO_SIDED|||||||||||||
72592464|NCT03495154|144715708|OTHER|Statistical Analysis is based on number of participants with incidence of ADEs within 3 months. Adverse Device Effects (ADE) is inclusive of both procedure and/or device related AEs.|Number of Subjects with ADEs|34.0|||||TWO_SIDED|||||||||||||
72592465|NCT03495154|144715708|OTHER|Statistical Analysis is based on number of participants with incidence of ADEs within 12 months. Adverse Device Effects (ADE) is inclusive of both procedure and/or device related AEs.|Number of Subjects with ADEs|40.0|||||TWO_SIDED|||||||||||||
72592466|NCT03495154|144715708|OTHER|Statistical Analysis is based on number of participants with incidence of ADEs within 24 months. Adverse Device Effects (ADEs) are inclusive of both procedure and device related AEs.|Number of Subjects with ADEs|42.0|||||TWO_SIDED|||||||||||||
72592467|NCT03495154|144715709|OTHER|This was not a comparative endpoint.|% of Subjects with Recurrence within 1M|0.0|||||TWO_SIDED|95.0|0.0|2.9||||||||2.9|0|
72592468|NCT03495154|144715709|OTHER|This was not a comparative endpoint.|% of Subjects with Recurrence within 3M|0.0|||||TWO_SIDED|95.0|0.0|3.0||||||||3.0|0|
72592469|NCT03495154|144715709|OTHER|This was not a comparative endpoint.|% of Subjects with Recurrence within 24M|4.0|||||TWO_SIDED|95.0|1.2|9.6||||||||9.6|1.2|
72592470|NCT05633992|144715778|NON_INFERIORITY|For the 12 serotypes common to both V116 and PPSV23, a conclusion of non-inferiority of V116 to PPSV23 requires the lower bound of the 2-sided 95% confidence interval of the OPA GMT ratio (V116/PPSV23) to be \>0.5 (one-sided p-value \<0.025).|Day 30 GMT Ratio|0.94|||<|0.001|TWO_SIDED|95.0|0.75|1.17|||Constrained Longitudinal Data Analysis|cLDA model with terms for vaccination group, time, interaction of time-by-vaccination, age stratum at baseline, and interaction of time-by-age stratum|Ratio is V116/PPSV23. GMT ratio and confidence interval estimated from the cLDA model. The cLDA model-based ratio includes estimated data for participants who had baseline data available but no day 30 measurement.|Serotype 3||1.17|0.75|<0.001
72592471|NCT05633992|144715778|NON_INFERIORITY|For the 12 serotypes common to both V116 and PPSV23, a conclusion of non-inferiority of V116 to PPSV23 requires the lower bound of the 2-sided 95% confidence interval of the OPA GMT ratio (V116/PPSV23) to be \>0.5 (one-sided p-value \<0.025).|Day 30 GMT Ratio|1.08|||<|0.001|TWO_SIDED|95.0|0.88|1.33|||Constrained Longitudinal Data Analysis|cLDA model with terms for vaccination group, time, interaction of time-by-vaccination, age stratum at baseline, and interaction of time-by-age stratum|Ratio is V116/PPSV23. GMT ratio and confidence interval estimated from the cLDA model. The cLDA model-based ratio includes estimated data for participants who had baseline data available but no day 30 measurement.|Serotype 7F||1.33|0.88|<0.001
72592472|NCT05633992|144715778|NON_INFERIORITY|For the 12 serotypes common to both V116 and PPSV23, a conclusion of non-inferiority of V116 to PPSV23 requires the lower bound of the 2-sided 95% confidence interval of the OPA GMT ratio (V116/PPSV23) to be \>0.5 (one-sided p-value \<0.025).|Day 30 GMT Ratio|1.12|||<|0.001|TWO_SIDED|95.0|0.93|1.36|||Constrained Longitudinal Data Analysis|cLDA model with terms for vaccination group, time, interaction of time-by-vaccination, age stratum at baseline, and interaction of time-by-age stratum|Ratio is V116/PPSV23. GMT ratio and confidence interval estimated from the cLDA model. The cLDA model-based ratio includes estimated data for participants who had baseline data available but no day 30 measurement.|Serotype 8||1.36|0.93|<0.001
72592473|NCT05633992|144715778|NON_INFERIORITY|For the 12 serotypes common to both V116 and PPSV23, a conclusion of non-inferiority of V116 to PPSV23 requires the lower bound of the 2-sided 95% confidence interval of the OPA GMT ratio (V116/PPSV23) to be \>0.5 (one-sided p-value \<0.025).|Day 30 GMT Ratio|1.05|||<|0.001|TWO_SIDED|95.0|0.86|1.29|||Constrained Longitudinal Data Analysis|cLDA model with terms for vaccination group, time, interaction of time-by-vaccination, age stratum at baseline, and interaction of time-by-age stratum|Ratio is V116/PPSV23. GMT ratio and confidence interval estimated from the cLDA model. The cLDA model-based ratio includes estimated data for participants who had baseline data available but no day 30 measurement.|Serotype 9N||1.29|0.86|<0.001
72592474|NCT05633992|144715778|NON_INFERIORITY|For the 12 serotypes common to both V116 and PPSV23, a conclusion of non-inferiority of V116 to PPSV23 requires the lower bound of the 2-sided 95% confidence interval of the OPA GMT ratio (V116/PPSV23) to be \>0.5 (one-sided p-value \<0.025).|Day 30 GMT Ratio|1.65|||<|0.001|TWO_SIDED|95.0|1.28|2.14|||Constrained Longitudinal Data Analysis|cLDA model with terms for vaccination group, time, interaction of time-by-vaccination, age stratum at baseline, and interaction of time-by-age stratum|Ratio is V116/PPSV23. GMT ratio and confidence interval estimated from the cLDA model. The cLDA model-based ratio includes estimated data for participants who had baseline data available but no day 30 measurement.|Serotype 10A||2.14|1.28|<0.001
72414598|NCT01362140|144339378|SUPERIORITY_OR_OTHER|||||||0.008|||||||Chi-squared|||"The primary hypothesis to be tested was that the percentage of participants with at least~1 RBC transfusion from week 5 to the EOTP was lower in the darbepoetin alfa group than in the placebo group. This hypothesis was confirmed if the incidence of RBC transfusion in the darbepoetin alfa group was lower and had a p-value \< 0.05 from a 2-sided Chi-square test."||||0.008
72414599|NCT01362140|144339379|SUPERIORITY_OR_OTHER|||||||0.017|||||||Cochran-Mantel-Haenszel|The overall 2-sided CMH test with IPSS score as stratification factor.||If the primary hypothesis was confirmed, the secondary hypothesis to be tested was that the percentage of participants achieving an IWG erythroid response during the 24-week double-blind treatment period was greater in the darbepoetin alfa group than in the placebo group. This hypothesis was confirmed if erythroid response was higher in the darbepoetin alfa group and the p-value was \< 0.05 from a 2-sided Cochran-Mantel-Haenszel test using the IPSS as a stratification factor.||||0.017
72421553|NCT01264380|144354236|SUPERIORITY_OR_OTHER||Ratio of Geometric Mean|2.45|||||TWO_SIDED|90.0|1.81|3.32||||||The point estimate and 90% CI of vemurafenib plasma Cmax geometric means ratios of the Fed to Fasted conditions following an oral administration of a single dose of 960 mg vemurafenib were analyzed.||3.32|1.81|
72592475|NCT05633992|144715778|NON_INFERIORITY|For the 12 serotypes common to both V116 and PPSV23, a conclusion of non-inferiority of V116 to PPSV23 requires the lower bound of the 2-sided 95% confidence interval of the OPA GMT ratio (V116/PPSV23) to be \>0.5 (one-sided p-value \<0.025).|Day 30 GMT Ratio|1.52|||<|0.001|TWO_SIDED|95.0|1.2|1.92|||Constrained Longitudinal Data Analysis|cLDA model with terms for vaccination group, time, interaction of time-by-vaccination, age stratum at baseline, and interaction of time-by-age stratum|Ratio is V116/PPSV23. GMT ratio and confidence interval estimated from the cLDA model. The cLDA model-based ratio includes estimated data for participants who had baseline data available but no day 30 measurement.|Serotype 11A||1.92|1.20|<0.001
72592476|NCT05633992|144715778|NON_INFERIORITY|For the 12 serotypes common to both V116 and PPSV23, a conclusion of non-inferiority of V116 to PPSV23 requires the lower bound of the 2-sided 95% confidence interval of the OPA GMT ratio (V116/PPSV23) to be \>0.5 (one-sided p-value \<0.025).|Day 30 GMT Ratio|1.97|||<|0.001|TWO_SIDED|95.0|1.43|2.72|||Constrained Longitudinal Data Analysis|cLDA model with terms for vaccination group, time, interaction of time-by-vaccination, age stratum at baseline, and interaction of time-by-age stratum|Ratio is V116/PPSV23. GMT ratio and confidence interval estimated from the cLDA model. The cLDA model-based ratio includes estimated data for participants who had baseline data available but no day 30 measurement.|Serotype 12F||2.72|1.43|<0.001
72592477|NCT05633992|144715778|NON_INFERIORITY|For the 12 serotypes common to both V116 and PPSV23, a conclusion of non-inferiority of V116 to PPSV23 requires the lower bound of the 2-sided 95% confidence interval of the OPA GMT ratio (V116/PPSV23) to be \>0.5 (one-sided p-value \<0.025).|Day 30 GMT Ratio|1.6|||<|0.001|TWO_SIDED|95.0|1.28|2.0|||Constrained Longitudinal Data Analysis|cLDA model with terms for vaccination group, time, interaction of time-by-vaccination, age stratum at baseline, and interaction of time-by-age stratum|Ratio is V116/PPSV23. GMT ratio and confidence interval estimated from the cLDA model. The cLDA model-based ratio includes estimated data for participants who had baseline data available but no day 30 measurement.|Serotype 17F||2.00|1.28|<0.001
72592478|NCT05633992|144715778|NON_INFERIORITY|For the 12 serotypes common to both V116 and PPSV23, a conclusion of non-inferiority of V116 to PPSV23 requires the lower bound of the 2-sided 95% confidence interval of the OPA GMT ratio (V116/PPSV23) to be \>0.5 (one-sided p-value \<0.025).|Day 30 GMT Ratio|1.16|||<|0.001|TWO_SIDED|95.0|0.93|1.45|||Constrained Longitudinal Data Analysis|cLDA model with terms for vaccination group, time, interaction of time-by-vaccination, age stratum at baseline, and interaction of time-by-age stratum|Ratio is V116/PPSV23. GMT ratio and confidence interval estimated from the cLDA model. The cLDA model-based ratio includes estimated data for participants who had baseline data available but no day 30 measurement.|Serotype 19A||1.45|0.93|<0.001
72414600|NCT01581281|144339430|SUPERIORITY||Odds Ratio (OR)|0.71||||0.2636|TWO_SIDED|98.3|0.34|1.48||A Bonferroni approach was used to control the type I error rate. Because there were three comparisons, the Bonferroni corrected level of significance is 0.017 (= 0.05 / 3).|Regression, Logistic|||"Logistic regression models were used to estimate the odds of successful primary endpoint for amitriptyline relative to placebo. The analyses followed the intention to treat principle, imputing an outcome of failure for any participant who withdrew early for any reason or did not provide week 24 headache diary data (endpoint data). The models, and corresponding odds ratios, were adjusted for the two stratification variables (age and baseline number of headache days)."||1.48|0.34|0.2636
72414601|NCT01581281|144339430|SUPERIORITY||Odds Ratio (OR)|0.81||||0.4821|TWO_SIDED|98.3|0.39|1.68||A Bonferroni approach was used to control the type I error rate. Because there were three comparisons of interest, the Bonferroni corrected level of significance is 0.017 ( = 0.05 / 3).|Regression, Logistic|||"Logistic regression models were used to estimate the odds of successful primary endpoint for topiramate relative to placebo. The analyses followed the intention to treat principle, imputing an outcome of failure for any participant who withdrew early for any reason or did not provide week 24 headache diary data (endpoint data). The models, and corresponding odds ratios, were adjusted for the two stratification variables (age and baseline number of headache days)."||1.68|0.39|0.4821
72592479|NCT05633992|144715778|NON_INFERIORITY|For the 12 serotypes common to both V116 and PPSV23, a conclusion of non-inferiority of V116 to PPSV23 requires the lower bound of the 2-sided 95% confidence interval of the OPA GMT ratio (V116/PPSV23) to be \>0.5 (one-sided p-value \<0.025).|Day 30 GMT Ratio|1.44|||<|0.001|TWO_SIDED|95.0|1.18|1.77|||Constrained Longitudinal Data Analysis|cLDA model with terms for vaccination group, time, interaction of time-by-vaccination, age stratum at baseline, and interaction of time-by-age stratum|Ratio is V116/PPSV23. GMT ratio and confidence interval estimated from the cLDA model. The cLDA model-based ratio includes estimated data for participants who had baseline data available but no day 30 measurement.|Serotype 20A||1.77|1.18|<0.001
72592480|NCT05633992|144715778|NON_INFERIORITY|For the 12 serotypes common to both V116 and PPSV23, a conclusion of non-inferiority of V116 to PPSV23 requires the lower bound of the 2-sided 95% confidence interval of the OPA GMT ratio (V116/PPSV23) to be \>0.5 (one-sided p-value \<0.025).|Day 30 GMT Ratio|1.39|||<|0.001|TWO_SIDED|95.0|1.1|1.76|||Constrained Longitudinal Data Analysis|cLDA model with terms for vaccination group, time, interaction of time-by-vaccination, age stratum at baseline, and interaction of time-by-age stratum|Ratio is V116/PPSV23. GMT ratio and confidence interval estimated from the cLDA model. The cLDA model-based ratio includes estimated data for participants who had baseline data available but no day 30 measurement.|Serotype 22F||1.76|1.10|<0.001
72592481|NCT05633992|144715778|NON_INFERIORITY|For the 12 serotypes common to both V116 and PPSV23, a conclusion of non-inferiority of V116 to PPSV23 requires the lower bound of the 2-sided 95% confidence interval of the OPA GMT ratio (V116/PPSV23) to be \>0.5 (one-sided p-value \<0.025).|Day 30 GMT Ratio|0.87|||<|0.001|TWO_SIDED|95.0|0.68|1.12|||Constrained Longitudinal Data Analysis|cLDA model with terms for vaccination group, time, interaction of time-by-vaccination, age stratum at baseline, and interaction of time-by-age stratum|Ratio is V116/PPSV23. GMT ratio and confidence interval estimated from the cLDA model. The cLDA model-based ratio includes estimated data for participants who had baseline data available but no day 30 measurement.|Serotype 33F||1.12|0.68|<0.001
72592482|NCT05633992|144715778|NON_INFERIORITY|For serotype 15B, a conclusion of non-inferiority of V116 to PPSV23 requires the lower bound of the 2-sided 95% confidence interval of the OPA GMT ratio (V116/PPSV23) to be \>0.5 (one-sided p-value \<0.025).|Day 30 GMT Ratio|1.43|||<|0.001|TWO_SIDED|95.0|1.07|1.89|||Constrained Longitudinal Data Analysis|cLDA model with terms for vaccination group, time, interaction of time-by-vaccination, age stratum at baseline, and interaction of time-by-age stratum|Ratio is V116/PPSV23. GMT ratio and confidence interval estimated from the cLDA model. The cLDA model-based ratio includes estimated data for participants who had baseline data available but no day 30 measurement.|Serotype 15B||1.89|1.07|<0.001
72592483|NCT05633992|144715778|SUPERIORITY|For serotype 15C, a conclusion of superiority of V116 to PPSV23 requires the lower bound of the 2-sided 95% confidence interval of the OPA GMT ratio (V116/PPSV23) to be \>1.0 (one-sided p-value \<0.025).|Day 30 GMT Ratio|2.05|||<|0.001|TWO_SIDED|95.0|1.56|2.7|||Constrained Longitudinal Data Analysis|cLDA model with terms for vaccination group, time, interaction of time-by-vaccination, age stratum at baseline, and interaction of time-by-age stratum|Ratio is V116/PPSV23. GMT ratio and confidence interval estimated from the cLDA model. The cLDA model-based ratio includes estimated data for participants who had baseline data available but no day 30 measurement.|Serotype 15C||2.70|1.56|<0.001
72592484|NCT05633992|144715779|SUPERIORITY|A conclusion of superiority of V116 to PPSV23 requires the lower bound of the 2-sided 95% confidence interval of the difference (V116-PPSV23) between the percentage of participants to be \>0 percentage points (one-sided p-value \<0.025).|Difference in Percent|27.6|||<|0.001|TWO_SIDED|95.0|17.8|36.9|||Stratified Miettinen & Nurminen||Estimated difference and confidence interval are based on the Miettinen \& Nurminen method.|Serotype 6A||36.9|17.8|<0.001
72592485|NCT05633992|144715779|SUPERIORITY|A conclusion of superiority of V116 to PPSV23 requires the lower bound of the 2-sided 95% confidence interval of the difference (V116-PPSV23) between the percentage of participants to be \>0 percentage points (one-sided p-value \<0.025).|Difference in Percent|33.7|||<|0.001|TWO_SIDED|95.0|23.6|43.0|||Stratified Miettinen & Nurminen||Estimated difference and confidence interval are based on the Miettinen \& Nurminen method.|Serotype 15A||43.0|23.6|<0.001
72592486|NCT05633992|144715779|SUPERIORITY|A conclusion of superiority of V116 to PPSV23 requires the lower bound of the 2-sided 95% confidence interval of the difference (V116-PPSV23) between the percentage of participants to be \>0 percentage points (one-sided p-value \<0.025).|Difference in Percent|38.3|||<|0.001|TWO_SIDED|95.0|29.8|46.4|||Stratified Miettinen & Nurminen||Estimated difference and confidence interval are based on the Miettinen \& Nurminen method.|Serotype 16F||46.4|29.8|<0.001
72592487|NCT05633992|144715779|SUPERIORITY|A conclusion of superiority of V116 to PPSV23 requires the lower bound of the 2-sided 95% confidence interval of the difference (V116-PPSV23) between the percentage of participants to be \>0 percentage points (one-sided p-value \<0.025).|Difference in Percent|29.5|||<|0.001|TWO_SIDED|95.0|17.4|40.6|||Stratified Miettinen & Nurminen||Estimated difference and confidence interval are based on the Miettinen \& Nurminen method.|Serotype 23A||40.6|17.4|<0.001
72421554|NCT01147822|144354243|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.0184|||||TWO_SIDED|95.0|0.7658|1.3542|||||The HR was estimated by the Cox regression model using treatment stratification factors as covariates. The HR was adjusted for Karnofsky Performance Scale scores, prior nephrectomy, and Baseline levels of lactate dehydrogenase.|||1.3542|0.7658|
72592488|NCT05633992|144715779|SUPERIORITY|A conclusion of superiority of V116 to PPSV23 requires the lower bound of the 2-sided 95% confidence interval of the difference (V116-PPSV23) between the percentage of participants to be \>0 percentage points (one-sided p-value \<0.025).|Difference in Percent|38.3|||<|0.001|TWO_SIDED|95.0|29.3|46.7|||Stratified Miettinen & Nurminen||Estimated difference and confidence interval are based on the Miettinen \& Nurminen method.|Serotype 23B||46.7|29.3|<0.001
72592489|NCT05633992|144715779|SUPERIORITY|A conclusion of superiority of V116 to PPSV23 requires the lower bound of the 2-sided 95% confidence interval of the difference (V116-PPSV23) between the percentage of participants to be \>0 percentage points (one-sided p-value \<0.025).|Difference in Percent|27.1|||<|0.001|TWO_SIDED|95.0|18.3|35.6|||Stratified Miettinen & Nurminen||Estimated difference and confidence interval are based on the Miettinen \& Nurminen method.|Serotype 24F||35.6|18.3|<0.001
72592490|NCT05633992|144715779|SUPERIORITY|A conclusion of superiority of V116 to PPSV23 requires the lower bound of the 2-sided 95% confidence interval of the difference (V116-PPSV23) between the percentage of participants to be \>0 percentage points (one-sided p-value \<0.025).|Difference in Percent|57.3|||<|0.001|TWO_SIDED|95.0|49.3|64.4|||Stratified Miettinen & Nurminen||Estimated difference and confidence interval are based on the Miettinen \& Nurminen method.|Serotype 31||64.4|49.3|<0.001
72414602|NCT01581281|144339430|SUPERIORITY||Odds Ratio (OR)|0.88||||0.6107|TWO_SIDED|98.3|0.49|1.59||A Bonferroni approach was used to control the type I error rate. Because there were three comparisons of interest, the Bonferroni corrected level of significance is 0.017 ( = 0.05 / 3).|Regression, Logistic|||"Logistic regression models were used to estimate the odds of successful primary endpoint for topiramate relative to amitriptyline. The analyses followed the intention to treat principle, imputing an outcome of failure for any participant who withdrew early for any reason or did not provide week 24 headache diary data (endpoint data). The models, and corresponding odds ratios, were adjusted for the two stratification variables (age and baseline number of headache days)."||1.59|0.49|0.6107
72592491|NCT05633992|144715779|SUPERIORITY|A conclusion of superiority of V116 to PPSV23 requires the lower bound of the 2-sided 95% confidence interval of the difference (V116-PPSV23) between the percentage of participants to be \>0 percentage points (one-sided p-value \<0.025).|Difference in Percent|47.0|||<|0.001|TWO_SIDED|95.0|39.5|54.1|||Stratified Miettinen & Nurminen||Estimated difference and confidence interval are based on the Miettinen \& Nurminen method.|Serotype 35B||54.1|39.5|<0.001
72592492|NCT04166591|144715826|OTHER|The primary statistical analysis involves asking whether children look at the target significantly more than chance levels. Binomial tests are used to see if the number of children who do so is significantly greater than would be expected by chance.|||||<|0.01|||||||binomial test|||||||<0.01
72592493|NCT04166591|144715826|OTHER|The primary statistical analysis involves asking whether children look at the target significantly more than chance levels. Binomial tests are used to see if the number of children who do so is significantly greater than would be expected by chance.|||||<|0.01|||||||Binomial test|||||||<0.01
72592494|NCT04166591|144715826|OTHER|The primary statistical analysis involves asking whether children look at the target significantly more than chance levels. Binomial tests are used to see if the number of children who do so is significantly greater than would be expected by chance.|||||<|0.01|||||||Binomial test|||||||<0.01
72592495|NCT04166591|144715826|OTHER|The primary statistical analysis involves asking whether children look at the target significantly more than chance levels. Binomial tests are used to see if the number of children who do so is significantly greater than would be expected by chance.|||||<|0.01|||||||Binomial test|||||||<0.01
72592496|NCT04166591|144715827|OTHER|The primary statistical analysis involves asking whether children look at the target significantly more than chance levels. Binomial tests are used to see if the number of children who do so is significantly greater than would be expected by chance.|||||<|0.01|||||||Binomial test|||||||<0.01
72592497|NCT04166591|144715827|OTHER|The primary statistical analysis involves asking whether children look at the target significantly more than chance levels. Binomial tests are used to see if the number of children who do so is significantly greater than would be expected by chance.||||||0.12|||||||Binomial test|||||||0.12
72592498|NCT04166591|144715827|OTHER|The primary statistical analysis involves asking whether children look at the target significantly more than chance levels. Binomial tests are used to see if the number of children who do so is significantly greater than would be expected by chance.|||||<|0.01|||||||Binomial test|||||||<0.01
72592499|NCT04166591|144715827|OTHER|The primary statistical analysis involves asking whether children look at the target significantly more than chance levels. Binomial tests are used to see if the number of children who do so is significantly greater than would be expected by chance.|||||<|0.01|||||||Binomial test|||||||<0.01
72592500|NCT02111746|144715828|SUPERIORITY|||||||0.934|||||||Wilcoxon (Mann-Whitney)|||||||0.934
72592501|NCT02111746|144715829|SUPERIORITY|||||||0.036|||||||Wilcoxon (Mann-Whitney)|||||||0.036
72592502|NCT02111746|144715830|SUPERIORITY|||||||0.014|||||||Wilcoxon (Mann-Whitney)|||||||0.014
72592503|NCT02111746|144715831|SUPERIORITY|||||||0.512|||||||Wilcoxon (Mann-Whitney)|||||||0.512
72592504|NCT02111746|144715832|SUPERIORITY|||||||0.449|||||||Wilcoxon (Mann-Whitney)|||||||0.449
72592505|NCT02111746|144715833|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||||||1
72592506|NCT02111746|144715834|SUPERIORITY|||||||0.774|||||||Wilcoxon (Mann-Whitney)|||||||0.774
72592507|NCT02111746|144715835|SUPERIORITY|||||||0.188|||||||Wilcoxon (Mann-Whitney)|||||||0.188
72592508|NCT02111746|144715836|SUPERIORITY|||||||0.202|||||||Wilcoxon (Mann-Whitney)|||||||0.202
72592509|NCT00401544|144715884|SUPERIORITY_OR_OTHER||Percentage of participants|71.0||||||95.0|63.0|80.0|||||Binomial proportion with confidence limit calculation using the normal approximation, and converted to percentages.|||80|63|
72592510|NCT00401544|144715884|SUPERIORITY_OR_OTHER||Percentage of participants|63.0||||||95.0|54.0|72.0|||||Binomial proportion with confidence limit calculation using the normal approximation, and converted to percentages.|||72|54|
72592511|NCT00401544|144715885|SUPERIORITY_OR_OTHER||Percentage of participants|73.0||||||95.0|64.0|81.0|||||Binomial proportion with confidence limit calculation using the normal approximation, and converted to percentages.|||81|64|
72592512|NCT00401544|144715885|SUPERIORITY_OR_OTHER||Percentage of participants|62.0||||||95.0|54.0|71.0|||||Binomial proportion with confidence limit calculation using the normal approximation, and converted to percentages.|||71|54|
72592513|NCT00401544|144715890|SUPERIORITY_OR_OTHER||Percentage of participants|36.0||||||95.0|27.0|44.0|||||Binomial proportion with confidence limit calculation using the normal approximation, and converted to percentages.|||44|27|
72592514|NCT00401544|144715890|SUPERIORITY_OR_OTHER||Percentage of participants|38.0||||||95.0|29.0|47.0|||||Binomial proportion with confidence limit calculation using the normal approximation, and converted to percentages.|||47|29|
72592515|NCT00401544|144715891|SUPERIORITY_OR_OTHER||Percentage of participants|35.0||||||95.0|27.0|44.0|||||Binomial proportion with confidence limit calculation using the normal approximation, and converted to percentages.|||44|27|
72414603|NCT01581281|144339431|SUPERIORITY||Mean Difference (Final Values)|-0.35||||0.9137|TWO_SIDED|95.0|-6.64|5.95|||Regression, Linear|||The mean change from baseline in PedMIDAS score over time for the three groups was assessed using a linear regression model for each of the three pairwise comparisons (Amitriptyline relative to placebo, Topiramate relative to placebo, and Amitriptyline relative to Topiramate), adjusted for the baseline PedMIDAS score. The models, and corresponding odds ratios, were adjusted for the two stratification variables (age and baseline number of headache days).||5.95|-6.64|0.9137
72592516|NCT00401544|144715891|SUPERIORITY_OR_OTHER||Percentage of participants|39.0||||||95.0|30.0|47.0|||||Binomial proportion with confidence limit calculation using the normal approximation, and converted to percentages.|||47|30|
72592517|NCT00401544|144715892|SUPERIORITY_OR_OTHER||Percentage of participants|26.0||||||95.0|15.0|38.0|||||Binomial proportion with confidence limit calculation using the normal approximation, and converted to percentages.|||38|15|
72592518|NCT00401544|144715892|SUPERIORITY_OR_OTHER||Percentage of participants|31.0||||||95.0|19.0|42.0|||||Binomial proportion with confidence limit calculation using the normal approximation, and converted to percentages.|||42|19|
72592519|NCT00401544|144715892|SUPERIORITY_OR_OTHER||Percentage of participants|28.0||||||95.0|17.0|40.0|||||Binomial proportion with confidence limit calculation using the normal approximation, and converted to percentages.|||40|17|
72592520|NCT00401544|144715892|SUPERIORITY_OR_OTHER||Percentage of participants|25.0||||||95.0|14.0|36.0|||||Binomial proportion with confidence limit calculation using the normal approximation, and converted to percentages.|||36|14|
72592521|NCT00401544|144715893|SUPERIORITY_OR_OTHER||Percentage of participants|68.0||||||95.0|59.0|76.0|||||Binomial proportion with confidence limit calculation using the normal approximation, and converted to percentages.|||76|59|
72592522|NCT00401544|144715893|SUPERIORITY_OR_OTHER||Percentage of participants|59.0||||||95.0|50.0|68.0|||||Binomial proportion with confidence limit calculation using the normal approximation, and converted to percentages.|||68|50|
72592523|NCT00401544|144715894|SUPERIORITY_OR_OTHER||Percentage of participants|53.0||||||95.0|44.0|62.0|||||Binomial proportion with confidence limit calculation using the normal approximation, and converted to percentages.|||62|44|
72592524|NCT00401544|144715894|SUPERIORITY_OR_OTHER||Percentage of participants|74.0||||||95.0|66.0|82.0|||||Binomial proportion with confidence limit calculation using the normal approximation, and converted to percentages.|||82|66|
72592525|NCT05129475|144715902|OTHER||Ratio of Adjusted Geometric Means|120.9|||||TWO_SIDED|90.0|109.3|133.74|||||Analysis done using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Ratio and 90% CI are expressed as percentages.|||133.74|109.30|
72592526|NCT05129475|144715903|OTHER||Ratio of Adjusted Geometric Means|119.67|||||TWO_SIDED|90.0|108.75|131.68|||||Analysis done using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Ratio and 90% CI are expressed as percentages.|||131.68|108.75|
72592527|NCT05129475|144715904|OTHER||Ratio of Adjusted Geometric Means|161.01|||||TWO_SIDED|90.0|139.05|186.44|||||Analysis done using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Ratio and 90% CI are expressed as percentages.|||186.44|139.05|
72592528|NCT00135798|144715913|SUPERIORITY_OR_OTHER|||||||0.0477||95.0||||One-sided test|Fisher Exact|||ITT analysis of pTVR: 0/13 Standard care vs. 11/46 Combined LADR-treated groups||||0.0477
72592529|NCT00135798|144715913|SUPERIORITY_OR_OTHER|||||||0.609||95.0|||||Chi-squared|||ITT analysis of LADR-treated: 5/24 Genotypes 1,4,6 vs 6/22 Genotypes 2,3||||0.6090
72592530|NCT00135798|144715914|SUPERIORITY_OR_OTHER|||||||0.2014||95.0||||One-sided test|Fisher Exact|||ITT analysis of CVR: 1/16 Standard care vs. 12/63 Combined LADR-treated groups||||0.2014
72592531|NCT00135798|144715914|SUPERIORITY_OR_OTHER|||||||0.9513||95.0|||||Chi-squared|||ITT analysis of LADR-treated: 6/31 Genotypes 1,4,6 vs 6/32 Genotypes 2,3||||0.9513
72592532|NCT00135798|144715915|SUPERIORITY_OR_OTHER|||||||0.0274||95.0||||One-sided test|Fisher Exact|||PP analysis of pTVR: 0/13 Standard care vs. 11/44 Combined LADR-treated groups||||0.0274
72592533|NCT00135798|144715915|SUPERIORITY_OR_OTHER|||||||0.6011||95.0|||||Chi-squared|||PP analysis of LADR-treated: 5/23 G1,4,6 vs 6/21 G2,3||||0.6011
72592534|NCT00135798|144715916|SUPERIORITY_OR_OTHER|||||||0.0153||95.0||||One-sided test|Fisher Exact|||PP analysis of CVR: 0/20 Standard care vs. 13/59 Combined LADR-treated groups||||0.0153
72592535|NCT00135798|144715916|SUPERIORITY_OR_OTHER|||||||0.8065||95.0|||||Chi-squared|||PP analysis of LADR-treated: 7/30 G1,4,6 vs 6/29 G2,3||||0.8065
72592536|NCT04186806|144715917|NON_INFERIORITY|Non-inferiority margin was 1.5 cm|Mean Difference (Final Values)|-0.3426|||||TWO_SIDED|95.0|-1.2601|0.5749||The conclusion of the non-inferiority test is based on the 95% confidence interval and not on a p value. A p value was not computed.|Mixed Models Analysis||Non-inferiority testing was carried out using 95% confidence intervals.|||0.5749|-1.2601|
72592537|NCT03687372|144715988|SUPERIORITY||Mean Difference (Final Values)|3.22||||0.0003|TWO_SIDED|95.0|1.67|6.22||P-Value test comparing the Patients Cleared of All Baseline Warts in the Active (A-101 45%) and vehicle groups.|Mixed Models Analysis|||A summary of the wart clearance at Visit 10.||6.22|1.67|0.0003
72592538|NCT03687372|144715989|SUPERIORITY|P-Value test comparing the Patients Cleared of All Baseline Warts in the Active (A-101 45%) and vehicle groups.|Mean Difference (Final Values)|2.14||||0.0024|TWO_SIDED|95.0|1.3|3.52|||Mixed Models Analysis|||||3.52|1.30|0.0024
72592539|NCT03687372|144715990|SUPERIORITY||Odds Ratio (OR)|14.12|||<|0.0001|TWO_SIDED|95.0|7.5|20.8|||Wilcoxon (Mann-Whitney)|||||20.8|7.5|<0.0001
72592540|NCT03687372|144715991|SUPERIORITY||Odds Ratio (OR)|3.22||||0.0009|TWO_SIDED|95.0|1.55|6.65|||Wilcoxon (Mann-Whitney)|||||6.65|1.55|0.0009
72592541|NCT03687372|144715992|SUPERIORITY||Hazard Ratio (HR)|2.56|||<|0.0001|TWO_SIDED||||||Log Rank|||||||<0.0001
72592542|NCT00380081|144716016|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Treatment effect|ANCOVA|||||||<0.001
72592543|NCT00380081|144716017|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Treatment effect|Cochran-Mantel-Haenszel|||||||<0.001
72592544|NCT00380081|144716018|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Treatment effect|ANCOVA|||||||<0.001
72592545|NCT00380081|144716019|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Treatment effect|ANCOVA|||||||<0.001
72592546|NCT00380081|144716020|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Treatment effect|ANCOVA|||||||<0.001
72592547|NCT00380081|144716021|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Treatment effect|ANCOVA|||||||<0.001
72592548|NCT00380081|144716022|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Treatment effect|Cochran-Mantel-Haenszel|||The outcome noted above reflects the all-night sleep quality rating of study subjects who had a scheduled awakening after approximately 4 hours of sleep, were kept awake for 30 minutes and then allowed to return to bed and to sleep. After 4 hours, they were awakened again and disconnected from the PSG apparatus. Morning testing was conducted that included the Sleep Quality questionnaire. Evaluation of the results should reflect the nature of the study and the scheduled sleep disturbance.||||<0.001
72592549|NCT00380081|144716023|SUPERIORITY_OR_OTHER||||||<|0.004||95.0||||Treatment effect|Cochran-Mantel-Haenszel|||||||<0.004
72592550|NCT00380081|144716024|SUPERIORITY_OR_OTHER|||||||0.012||95.0||||Treatment effect|Cochran-Mantel-Haenszel|||||||0.012
72592551|NCT00380081|144716025|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Treatment effect|ANCOVA|||||||<0.001
72592552|NCT00380081|144716026|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Treatment effect|ANCOVA|||||||<0.001
72592553|NCT00380081|144716027|SUPERIORITY_OR_OTHER|||||||0.79||95.0||||Treatment effect|ANCOVA|||||||0.790
72592554|NCT00380081|144716028|SUPERIORITY_OR_OTHER|||||||0.083||95.0||||Treatment effect|ANCOVA|||||||0.083
72592555|NCT00380081|144716029|SUPERIORITY_OR_OTHER|||||||0.072||95.0||||Treatment effect|ANCOVA|||||||0.072
72592556|NCT00380081|144716029|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Period effect|ANCOVA|||||||<0.001
72592557|NCT00380081|144716030|SUPERIORITY_OR_OTHER|||||||0.017||95.0||||Treatment effect|ANCOVA|||||||0.017
72592558|NCT00985959|144716057|SUPERIORITY_OR_OTHER||Overall response rate (%)|69.8|STANDARD_ERROR_OF_MEAN|4.9|<|0.0001|TWO_SIDED|95.0|58.9|79.2||Significance level 5% one-tailed. Threshold response rate 35%|Binominal test|||||79.2|58.9|<0.0001
72592559|NCT02858180|144716073|OTHER||Proportion|86.7|||||TWO_SIDED|95.0|59.5|98.3||||||||98.3|59.5|
72592560|NCT00574249|144716078|SUPERIORITY_OR_OTHER|||||||0.086||||||Level of significance 5%; no adjustment for multiple comparisons necessary.|Cochran-Mantel-Haenszel|Two-sided CMH test stratified by country at the alpha level 0.05. Centers were pooled by country (Sweden and Finland pooled due to few participants).||Comparison of the proportion of participants in the adalimumab + calcipotriol/betamethasone group vs. the adalimumab + placebo group.||||0.086
72592561|NCT00574249|144716079|SUPERIORITY_OR_OTHER|||||||0.565||95.0|||||Fisher Exact|||||||0.565
72592562|NCT00574249|144716080|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||Fisher Exact|||||||0.002
72592563|NCT00574249|144716081|SUPERIORITY_OR_OTHER|||||||0.003||95.0|||||Fisher Exact|||||||0.003
72592564|NCT00574249|144716082|SUPERIORITY_OR_OTHER|||||||0.004||95.0|||||Fisher Exact|||||||0.004
72592565|NCT00574249|144716083|SUPERIORITY_OR_OTHER|||||||0.011||95.0|||||Fisher Exact|||||||0.011
72592566|NCT00574249|144716084|SUPERIORITY_OR_OTHER||Mean Difference (Net)|9.74||||0.204||95.0|-5.3|24.78|||ANOVA|One-way ANOVA. For confidence interval and difference estimate, adalimumab + calcipotriol/betamethasone minus adalimumab + placebo was used.||||24.78|-5.30|0.204
72592567|NCT00574249|144716085|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-17.55||||0.272||95.0|-48.92|13.82|||ANOVA|One-way ANOVA. Confidence interval and difference estimated from adalimumab + calcipotriol/betamethasone minus adalimumab + placebo.||||13.82|-48.92|0.272
72592568|NCT00574249|144716086|SUPERIORITY_OR_OTHER|||||||0.413||95.0|||||Fisher Exact|||||||0.413
72592569|NCT00574249|144716087|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Fisher Exact|||||||<0.001
72592570|NCT00574249|144716088|SUPERIORITY_OR_OTHER|||||||0.028||95.0|||||Fisher Exact|||||||0.028
72592571|NCT00574249|144716089|SUPERIORITY_OR_OTHER|||||||0.228||95.0|||||ANOVA|One-way ANOVA.||||||0.228
72592572|NCT00574249|144716090|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA|One-way ANOVA.||||||< 0.001
72592573|NCT00574249|144716091|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||ANOVA|One-way ANOVA.||||||0.001
72592574|NCT00574249|144716092|SUPERIORITY_OR_OTHER|||||||0.764||95.0|||||ANOVA|One-way ANOVA.||||||0.764
72592575|NCT00574249|144716093|SUPERIORITY_OR_OTHER|||||||0.437||95.0|||||ANOVA|One-way ANOVA.||||||0.437
72592576|NCT00574249|144716094|SUPERIORITY_OR_OTHER|||||||0.74||95.0|||||ANOVA|One-way ANOVA.||||||0.740
72592577|NCT00574249|144716095|SUPERIORITY_OR_OTHER|||||||0.634||95.0|||||ANOVA|One-way ANOVA.||||||0.634
72592578|NCT04601103|144716101|OTHER|Generalized Fisher's Exact Test was used to detect an association between the 3 treatment groups and the incidence of sloughing||||||0.916|||||||Fisher Exact|||||||.916
72592579|NCT04713592|144716144|SUPERIORITY||Rate Difference|17.2|||=|0.006|TWO_SIDED|95.0|5.0|29.3||P-value based on Cochran-Mantel-Haenszel (CMH) test adjusted for Baseline ppIGA and Baseline BSA categories for comparison of treatment groups based on non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19.|Cochran-Mantel-Haenszel||Difference: Risankizumab - Placebo|Risankizumab vs Placebo at Week 16||29.3|5.0|=0.006
72592580|NCT04713592|144716146|SUPERIORITY||Rate Difference|27.6|||<|0.001|TWO_SIDED|95.0|15.4|39.7||P-value based on Cochran-Mantel-Haenszel (CMH) test adjusted for Baseline ppIGA and Baseline BSA categories for comparison of treatment groups based on non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19.|Cochran-Mantel-Haenszel||Difference: Risankizumab - Placebo|Risankizumab vs Placebo at Week 16||39.7|15.4|<0.001
72592581|NCT04713592|144716147|SUPERIORITY||Rate Difference|21.8|||<|0.001|TWO_SIDED|95.0|11.5|32.1||P-value based on Cochran-Mantel-Haenszel (CMH) test adjusted for Baseline ppIGA and Baseline BSA categories for comparison of treatment groups based on non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19.|Cochran-Mantel-Haenszel||Difference: Risankizumab - Placebo|Risankizumab vs Placebo at Week 16||32.1|11.5|<0.001
72421555|NCT01147822|144354244|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.08||||0.604|TWO_SIDED|95.0|0.808|1.441|||Log Rank||Hazard ratios were estimated using the Pike estimator. A hazard ratio \<1 indicates a lower risk with this treatment compared with Sunitinib.|||1.441|0.808|0.604
72592582|NCT04713592|144716148|SUPERIORITY||Rate Difference|20.7|||<|0.001|TWO_SIDED|95.0|9.1|32.2||P-value based on Cochran-Mantel-Haenszel (CMH) test adjusted for Baseline ppIGA and Baseline BSA categories for comparison of treatment groups based on non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19.|Cochran-Mantel-Haenszel||Difference: Risankizumab - Placebo|Risankizumab vs Placebo at Week 16||32.2|9.1|<0.001
72592583|NCT04713592|144716149|SUPERIORITY||Rate Difference|16.2|||<|0.001|TWO_SIDED|95.0|8.2|24.3||P-value based on Cochran-Mantel-Haenszel (CMH) test adjusted for Baseline ppIGA and Baseline BSA categories for comparison of treatment groups based on non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19.|Cochran-Mantel-Haenszel||Difference: Risankizumab - Placebo|Risankizumab vs Placebo at Week 16||24.3|8.2|<0.001
72421556|NCT05383417|144354259|SUPERIORITY|||||||0.03|||||||t-test, 1 sided|||||||0.03
72414604|NCT01581281|144339431|SUPERIORITY||Median Difference (Final Values)|-4.84||||0.1331|TWO_SIDED|95.0|-11.16|1.49|||Regression, Linear|||The mean change from baseline in PedMIDAS score over time for the three groups was assessed using a linear regression model for each of the three pairwise comparisons (Amitriptyline relative to placebo, Topiramate relative to placebo, and Amitriptyline relative to Topiramate), adjusted for the baseline PedMIDAS score. The models, and corresponding odds ratios, were adjusted for the two stratification variables (age and baseline number of headache days).||1.49|-11.16|0.1331
72414605|NCT01581281|144339431|SUPERIORITY||Mean Difference (Final Values)|4.49||||0.1011|TWO_SIDED|95.0|-0.88|9.87|||Regression, Linear|||The mean change from baseline in PedMIDAS score over time for the three groups was assessed using a linear regression model for each of the three pairwise comparisons (Amitriptyline relative to placebo, Topiramate relative to placebo, and Amitriptyline relative to Topiramate), adjusted for the baseline PedMIDAS score. The models, and corresponding odds ratios, were adjusted for the two stratification variables (age and baseline number of headache days).||9.87|-0.88|0.1011
72421557|NCT05383417|144354260|SUPERIORITY|||||||0.18|||||||t-test, 1 sided|||||||0.18
72592584|NCT02294175|144716197|SUPERIORITY|||||||0.029||||||Repeated Measures ANOVA. The interaction effect is controlling for any potential main effects of treatment arm (SDT vs LDT) and time (days 0, 4, 8).|Repeated Measures ANOVA|Greenhouse-Geisser corrections were applied to the F test degrees of freedom due to violation of the sphericity assumption (p\<.05 for Mauchly's W).||Repeated Measures Analysis of Variance (RMANOVA) to test for effects of treatment arm, time, and treatment-by-time interaction. The effect of interest is the treatment-by-time interaction, i.e, whether the reduction of bacterial CFUs over time varies according to treatment arm.||||.029
72592585|NCT02294175|144716198|SUPERIORITY|||||||0.037||||||Repeated Measures ANOVA. This interaction effect is controlling for any potential main effects of treatment arm (SDT vs LDT) and time (days 0, 4, 8).|Repeated Measures ANOVA|Greenhouse-Geisser corrections were applied to the F test degrees of freedom due to violation of the sphericity assumption (p\<.05 for Mauchly's W).||Repeated Measures Analysis of Variance (RMANOVA) to test for effects of treatment arm, time, and treatment-by-time interaction. The effect of interest is the treatment-by-time interaction, i.e, whether the reduction of bacterial CFUs over time varies according to treatment arm.||||.037
72592586|NCT02294175|144716199|SUPERIORITY|||||||0.012||||||Repeated Measures ANOVA. This interaction effect is controlling for any potential main effects of treatment arm (SDT vs LDT) and time (days 0, 4, 8).|Repeated Measures ANOVA|||Repeated Measures Analysis of Variance (RMANOVA) to test for effects of treatment arm, time, and treatment-by-time interaction. The effect of interest is the treatment-by-time interaction, i.e, whether the reduction of bacterial CFUs over time varies according to treatment arm.||||.012
72592587|NCT02294175|144716200|SUPERIORITY|||||||0.397|||||||t-test, 2 sided|||||||.397
72592588|NCT02294175|144716201|SUPERIORITY|||||||0.661||||||Repeated Measures ANOVA. The interaction effect is controlling for any potential main effects of treatment arm (SDT vs LDT) and time (days 0, 4, 8).|Repeated Measures ANOVA|||Repeated Measures Analysis of Variance (RMANOVA) to test for effects of treatment arm, time, and treatment-by-time interaction. The effect of interest is the treatment-by-time interaction, i.e, whether change in MMP-9 over time varies according to treatment arm.||||.661
72592589|NCT02294175|144716202|SUPERIORITY|||||||0.979||||||Repeated Measures ANOVA. The interaction effect is controlling for any potential main effects of treatment arm (SDT vs LDT) and time (days 0, 4, 8).|Repeated Measures ANOVA|||Repeated Measures Analysis of Variance (RMANOVA) to test for effects of treatment arm, time, and treatment-by-time interaction. The effect of interest is the treatment-by-time interaction, i.e, whether change in IL6 over time varies according to treatment arm.||||.979
72421558|NCT05383417|144354261|SUPERIORITY|||||||0.007|||||||t-test, 1 sided|Day 2||||||0.007
72421559|NCT05383417|144354261|SUPERIORITY|||||||0.04|||||||t-test, 1 sided|Day 7||||||0.04
72421560|NCT05383417|144354262|SUPERIORITY|||||||0.03|||||||t-test, 1 sided|Day 1||||||0.03
72592590|NCT02294175|144716203|SUPERIORITY|||||||0.999|||||||Kolmogorov-Smirnov Z|||Kolmogorov-Smirnov Z test was used as a non-parametric test to compare rank scores between treatment arms (similar to Mann-Whitney, but potentially more powerful).||||.999
72592591|NCT02294175|144716204|SUPERIORITY|||||||0.415|||||||Kolmogorov-Smirnov Z|||Kolmogorov-Smirnov Z test was used as a non-parametric test to compare rank scores between treatment arms (similar to Mann-Whitney, but potentially more powerful).||||.415
72592592|NCT02294175|144716205|SUPERIORITY|||||||0.993|||||||Kolmogorov-Smirnov Z|||Kolmogorov-Smirnov Z test was used as a non-parametric test to compare rank scores between treatment arms (similar to Mann-Whitney, but potentially more powerful).||||.993
72592593|NCT02294175|144716206|SUPERIORITY|||||||0.99|||||||Kolmogorov-Smirnov Z|||Kolmogorov-Smirnov Z test was used as a non-parametric test to compare rank scores between treatment arms (similar to Mann-Whitney, but potentially more powerful).||||.990
72592594|NCT02548351|144716207|OTHER||Hazard Ratio (HR)|0.814||||0.1028|TWO_SIDED|95.0|0.635|1.043|||Log Rank|||||1.043|0.635|0.1028
72592595|NCT02548351|144716207|OTHER||Hazard Ratio (HR)|0.772||||0.0444|TWO_SIDED|95.0|0.6|0.994|||Log Rank|||||0.994|0.600|0.0444
72592596|NCT02548351|144716208|OTHER||Difference in percentages|7.1|||<|0.0001|TWO_SIDED|95.0|3.6|10.6|||Cochran-Mantel-Haenszel|||||10.6|3.6|<0.0001
72592597|NCT02548351|144716208|OTHER||Treatment difference|9.4|||<|0.0001|TWO_SIDED|95.0|5.8|13.0|||Cochran-Mantel-Haenszel|||||13.0|5.8|<0.0001
72592598|NCT02548351|144716209|OTHER||Treatment difference|6.7||||0.0004|TWO_SIDED|95.0|3.0|10.4|||Cochran-Mantel-Haenszel|||||10.4|3.0|0.0004
72592599|NCT02548351|144716209|OTHER||Treatment difference|9.0|||<|0.0001|TWO_SIDED|95.0|5.2|12.8|||Cochran-Mantel-Haenszel|||||12.8|5.2|<0.0001
72592600|NCT00792688|144716211|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0062||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0062
72592601|NCT00792688|144716211|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0331||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0331
72592602|NCT00125242|144716213|SUPERIORITY_OR_OTHER||effect size|7.15|STANDARD_DEVIATION|3.1|||TWO_SIDED||||||||the reported effect size is a d-index value|Effect sizes were calculated - this is a comparison of perfomance in baseline (repeated measurements prior to treatment) relative to peformance following treatment||||
72592603|NCT00606554|144716214|SUPERIORITY_OR_OTHER|||||||0.6||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.60
72592604|NCT00606554|144716218|SUPERIORITY_OR_OTHER|||||||0.06||95.0|||||Chi-squared|||||||0.06
72592605|NCT00606554|144716221|SUPERIORITY_OR_OTHER|||||||0.9|||||||Chi-squared|||||||0.90
72592606|NCT05238025|144716240|OTHER|Vaccine Efficacy (VE) is defined as 1 minus the hazard ratio resulting from a Cox proportional hazards regression model stratified by age group. It is demonstrated if the lower limit (LL) of the 2-sided 95% confidence interval (CI) for VE is above 20%|Vaccine Efficacy|42.9|||||TWO_SIDED|95.0|-16.1|71.9||||||||71.9|-16.1|
72592607|NCT05238025|144716241|OTHER|Vaccine Efficacy (VE) is defined as 1 minus the hazard ratio resulting from a Cox proportional hazards regression model stratified by age group. It is demonstrated if the first primary outcome is met and the lower limit (LL) of the 2-sided 95% confidence interval (CI) for VE is above 20%|Vaccine Efficacy|59.0|||||TWO_SIDED|95.0|34.7|74.3|||||Not formally tested, since the first primary outcome was not met|||74.3|34.7|
72592608|NCT05238025|144716242|OTHER|Vaccine Efficacy (VE) is defined as 1 minus the hazard ratio resulting from a Cox proportional hazards regression model stratified by age group. It is demonstrated if both primary outcomes are met and the lower limit (LL) of the 2-sided 95% confidence interval (CI) for VE is above 20%|Vaccine Efficacy|48.8|||||TWO_SIDED|95.0|25.8|64.7|||||Not formally tested, since the first primary outcome was not met|||64.7|25.8|
72421561|NCT05383417|144354262|SUPERIORITY|||||||0.04|||||||t-test, 1 sided|Day 7||||||0.04
72414606|NCT01581281|144339432|SUPERIORITY||Mean Difference (Final Values)|-0.72||||0.3553|TWO_SIDED|98.3|-2.59|1.15||Each comparison was tested using a Bonferroni corrected significance level of 0.017 (0.05/3).|Regression, Linear|||Another major secondary objective was to determine if the change in absolute headache days from baseline to week 24 differed between treatment groups. This objective was assessed using linear regression models, with three pairwise comparisons between treatment groups (Amitriptyline vs. Placebo, Topiramate vs. Placebo, and Amitriptyline vs. Topiramate). The models, and corresponding odds ratios, were adjusted for the two stratification variables (age and baseline number of headache days).||1.15|-2.59|0.3553
72421562|NCT05383417|144354263|SUPERIORITY|||||||0.04|||||||t-test, 1 sided|Day 1||||||0.04
72592609|NCT03197324|144716266|EQUIVALENCE|The acceptance range for bioequivalence is 80.0 - 125.00%.|Ratio of Geometric LSM|100.4|||||TWO_SIDED|90.0|86.49|116.56|||||Digoxin group is the denominator and Digoxin with Bexagliflozin is the numerator. Confidence interval from ANOVA with treatment, period, and sequence as fixed effects, and subjects as a random effect.|Geometric LS Mean was used as PK parameters||116.56|86.49|
72592610|NCT03197324|144716269|SUPERIORITY|Compare if co-administration of digoxin with bexagliflozin had significant impact on the PK of digoxin|Ratio of Geometric LSM|106.12|||||TWO_SIDED|90.0|95.82|117.53|||||Digoxin group is the denominator and Digoxin with Bexagliflozin is the numerator. Confidence interval from ANOVA with treatment, period, and sequence as fixed effects, and subjects as a random effect.|Geometric LS Mean was used as PK parameters||117.53|95.82|
72592611|NCT02156895|144716288|OTHER||Odds Ratio (OR)|1.1||||0.1244|TWO_SIDED|95.0|0.97|1.24|||Regression, Logistic|Multiple logistic regression including total duration of treatment with Inlyta as factor||||1.24|0.97|0.1244
72592612|NCT02156895|144716294|OTHER||Odds Ratio (OR)|1.11||||0.0109|TWO_SIDED|95.0|1.02|1.2|||Regression, Logistic|Multiple logistic regression including total duration of treatment with Inlyta as factor||||1.2|1.02|0.0109
72592613|NCT03051516|144716340|SUPERIORITY|||||||0.89|||||||Chi-squared|||This p-value compares HPV16 persistence by study arm.||||0.89
72592614|NCT03051516|144716340|SUPERIORITY|||||||0.65|||||||Chi-squared|||This p-value compares HPV18/45 persistence by study arm.||||0.65
72592615|NCT03051516|144716340|SUPERIORITY|||||||0.056|||||||Chi-squared|||This p-value compares HPV31/33/52/58 persistence by study arm.||||0.056
72592616|NCT03051516|144716340|SUPERIORITY|||||||0.38|||||||Chi-squared|||This p-value compares HPV35/39/51/56/59 persistence by study arm.||||0.38
72592617|NCT03051516|144716340|SUPERIORITY|||||||0.33||||||This p-value compares overall HPV persistence and is not specific to HPV genotype.|Chi-squared|||||||0.33
72592618|NCT03051516|144716341|SUPERIORITY|||||||0.54|||||||Log Rank|||||||0.54
72592619|NCT03051516|144716342|OTHER|Descriptive analysis||||||0.135|||||||Chi-squared|||This comparison is specific to the incidence of fever or chills.||||0.135
72592620|NCT03051516|144716342|OTHER|Descriptive analysis||||||0.64|||||||Chi-squared|||This comparison is specific to the incidence of headache.||||0.640
72592621|NCT03051516|144716342|OTHER|Descriptive analysis||||||0.838|||||||Chi-squared|||This comparison is specific to the incidence of fatigue.||||0.838
72421563|NCT05383417|144354264|SUPERIORITY|||||||0.02|||||||t-test, 1 sided|Day2||||||0.02
72592622|NCT03051516|144716342|OTHER|Descriptive analysis||||||0.917|||||||Chi-squared|||This comparison is specific to the incidence of muscle aches.||||0.917
72592623|NCT03051516|144716342|OTHER|Descriptive analysis||||||0.005|||||||Chi-squared|||This comparison is specific to the incidence of pain at injection site.||||0.005
72592624|NCT03051516|144716342|OTHER|Descriptive analysis||||||0.001|||||||Chi-squared|||This comparison is specific to the incidence of tenderness at injection site.||||0.001
72592625|NCT03051516|144716342|OTHER|Descriptive analysis||||||0.004|||||||Chi-squared|||This comparison is specific to the incidence of swelling at injection site.||||0.004
72592626|NCT03051516|144716342|OTHER|Descriptive analysis||||||0.133|||||||Chi-squared|||This comparison is specific to the incidence of medical attention/medication required.||||0.133
72592627|NCT03051516|144716343|SUPERIORITY|||||||0.93|||||||Log Rank|||This p-value compares HSIL recurrence and presence of HPV16, in Arm I (Vaccine)||||0.93
72592628|NCT03051516|144716343|SUPERIORITY|||||||0.77|||||||Log Rank|||This p-value compares HSIL recurrence and presence of HPV18, in Arm I (Vaccine)||||0.77
72592629|NCT03051516|144716343|SUPERIORITY|||||||0.57|||||||Log Rank|||This p-value compares HSIL recurrence and presence of HPV31, in Arm I (Vaccine)||||0.57
72592630|NCT03051516|144716343|SUPERIORITY|||||||0.73|||||||Log Rank|||This p-value compares HSIL recurrence and presence of HPV33, in Arm I (Vaccine)||||0.73
72592631|NCT03051516|144716343|SUPERIORITY|||||||0.998|||||||Log Rank|||This p-value compares HSIL recurrence and presence of HPV45, in Arm I (Vaccine)||||0.998
72592632|NCT03051516|144716343|SUPERIORITY|||||||0.93|||||||Log Rank|||This p-value compares HSIL recurrence and presence of HPV52, in Arm I (Vaccine)||||0.93
72592633|NCT03051516|144716343|SUPERIORITY|||||||0.95|||||||Log Rank|||This p-value compares HSIL recurrence and presence of HPV58, in Arm I (Vaccine)||||0.95
72592634|NCT03051516|144716343|SUPERIORITY|||||||0.91|||||||Log Rank|||This p-value compares HSIL recurrence and presence of any HPV type, in Arm I (Vaccine)||||0.91
72592635|NCT03051516|144716343|SUPERIORITY|||||||0.22|||||||Log Rank|||This p-value compares HSIL recurrence and presence of HPV16, in Arm II (Placebo)||||0.22
72592636|NCT03051516|144716343|SUPERIORITY|||||||0.27|||||||Log Rank|||This p-value compares HSIL recurrence and presence of HPV18, in Arm II (Placebo)||||0.27
72592637|NCT03051516|144716343|SUPERIORITY|||||||0.72|||||||Log Rank|||This p-value compares HSIL recurrence and presence of HPV31, in Arm II (Placebo)||||0.72
72592638|NCT03051516|144716343|SUPERIORITY|||||||0.71|||||||Log Rank|||This p-value compares HSIL recurrence and presence of HPV33, in Arm II (Placebo)||||0.71
72592639|NCT03051516|144716343|SUPERIORITY|||||||0.11|||||||Log Rank|||This p-value compares HSIL recurrence and presence of HPV45, in Arm II (Placebo)||||0.11
72592640|NCT03051516|144716343|SUPERIORITY|||||||0.58|||||||Log Rank|||This p-value compares HSIL recurrence and presence of HPV52, in Arm II (Placebo)||||0.58
72592641|NCT03051516|144716343|SUPERIORITY|||||||0.81|||||||Log Rank|||This p-value compares HSIL recurrence and presence of HPV58, in Arm II (Placebo)||||0.81
72592642|NCT03051516|144716343|SUPERIORITY|||||||0.73|||||||Log Rank|||This p-value compares HSIL recurrence and presence of any HPV type, in Arm II (Placebo)||||0.73
72592643|NCT02339155|144716347|NON_INFERIORITY|If the upper bound of the 90% confidence interval (CI) or the ratio of anti-PA Ab (attributable to AVA) GMCs between the AVA and the AVA + raxibacumab groups at Week 4 is less than 1.5, non-inferiority was to be established.|Ratio|1.18||||0.0016|TWO_SIDED|90.0|1.03|1.35|||t-test, 1 sided|||||1.35|1.03|0.0016
72592644|NCT02339155|144716348|OTHER||Ratio|1.09|||||TWO_SIDED|90.0|0.98|1.22|||t-test, 1 sided||Week 8|||1.22|0.98|
72592645|NCT02339155|144716348|OTHER||Ratio|0.98|||<|0.0001|TWO_SIDED|90.0|0.89|1.07|||t-test, 1 sided||Week 26|||1.07|0.89|<0.0001
72592646|NCT01041976|144716412|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Chi-squared|||||||<0.001
72592647|NCT01041976|144716413|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Chi-squared|||||||<0.05
72592648|NCT02231879|144716415|SUPERIORITY|This is a two-sided test, with the null hypothesis that the distribution of the difference scores is the same in both arms.||||||0.65||||||Not adjusted for multiple comparisons, since this is the only pre-specified primary analysis. P\<=0.05 is considered significant.|Wilcoxon (Mann-Whitney)|||This was a pre-specified primary analysis plan, and the two arms are compared with a Wilcoxon-Mann-Whitney test on the primary outcome. This is non-standard (since both arms contain both treatment groups), however, it is a valid test by randomization since it is a permutation test. The statistic of TISS in Period 1 minus TISS in Period 2 was chosen so that even if there are carry-over effects this will give a valid test.||||0.65
72592649|NCT02231879|144716415|SUPERIORITY||||||<|0.0001||||||Not adjusted for multiple comparisons, one-sided test, a priori significance set at 0.025|McNemar|||Maintenance of absolute lymphocyte count greater than 1000 cells/microliter measured 3 hours after a dose for plerixafor as compared to G-CSF||||<0.0001
72592650|NCT02231879|144716415|NON_INFERIORITY|Pre-specified non-inferiority margin of 0.40 which was estimated to be about 50% of the effect size of G-CSF versus placebo.||||||0.023||||||Not adjusted for multiple comparisons, one-sided test, a priori significance set at 0.025|McNemar|||Maintenance of absolute neutrophil counts \>500 cells/microliter for G-CSF versus plerixafor measured as the proportion of successes (75% of measured) while on G-CSF minus the proportion on plerixafor||||0.023
72592651|NCT01210495|144716416|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.907||||0.2872|TWO_SIDED|95.0|0.646|1.274||For the overall stratified analysis the p-value is from a 1-sided log-rank test of treatment stratified by tumor invasion and geographic region.|Log Rank||Assuming proportional hazards, a hazard ratio less than (\<) 1 indicated reduction in hazard rate to favor Axitinib; hazard ratio greater than (\>) 1 indicated reduction to favor Placebo.|The study was designed to test the null hypothesis that the true median OS was 5 months vs. the alternative hypothesis that the true median OS was at least 8.3 months (i.e., 66 percent \[%\] improvement in median OS).||1.274|0.646|0.2872
72592652|NCT01210495|144716417|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.618||||0.0039|TWO_SIDED|95.0|0.438|0.871||For the overall stratified analysis the p-value is from a 1-sided log-rank test of treatment stratified by tumor invasion and geographic region.|Log Rank||Assuming proportional hazards, a hazard ratio \<1 indicated a reduction in hazard rate in favor of Axitinib; a hazard ratio \>1 indicated a reduction in favor of Placebo.|||0.871|0.438|0.0039
72592653|NCT01210495|144716418|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|3.172||||0.0914|TWO_SIDED|95.0|0.759|13.265||ORR for the 2 treatment arms was compared with a significance level of 0.025 using Cochran-Mantel-Haenszel (CMH) test for stratified analyses.|Cochran-Mantel-Haenszel||Risk ratio and confidence interval (CI) were based on the Mantel-Haenszel estimator; risk ratio was adjusted for geographical region and vascular invasion and extra hepatic spread.|||13.265|0.759|0.0914
72592654|NCT01210495|144716419|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.621||||0.006|TWO_SIDED|95.0|0.434|0.889||For the overall stratified analysis the p-value is from a 1-sided log-rank test of treatment stratified by tumor invasion and geographic region.|Log Rank||Assuming proportional hazards, a hazard ratio \<1 indicated a reduction in hazard rate in favor of Axitinib; a hazard ratio \>1 indicated a reduction in favor of Placebo.|||0.889|0.434|0.006
72592655|NCT01210495|144716421|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|2.65||||0.0025|TWO_SIDED|95.0|1.319|5.326||For the overall stratified analysis the p-value is from Cochran-Mantel-Haenszel test of treatment stratified by geographical region and vascular invasion and extra hepatic spread.|Cochran-Mantel-Haenszel||Risk Ratio and CI based on the Mantel-Haenszel estimator; risk ratio was adjusted for geographical region and vascular invasion and extra hepatic spread.|||5.326|1.319|0.0025
72592656|NCT01210495|144716430|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.89||||0.0006|TWO_SIDED|95.0|-18.7|-5.08||No adjustment made for multiple comparisons.|Longitudinal mixed effect analysis|||Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.||-5.08|-18.70|0.0006
72421564|NCT05383417|144354265|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
72421565|NCT05383417|144354266|SUPERIORITY|||||||0.007|||||||Chi-squared|||||||0.007
72421566|NCT05383417|144354267|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
72421567|NCT05383417|144354268|SUPERIORITY|||||||0.39|||||||Chi-squared|||||||0.39
72592657|NCT01210495|144716431|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.6||||0.0014|TWO_SIDED|95.0|-12.27|-2.94||No adjustment made for multiple comparisons.|Longitudinal mixed effect analysis|||Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.||-2.94|-12.27|0.0014
72592658|NCT01210495|144716432|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.27|||<|0.0001|TWO_SIDED|95.0|-4.76|-1.78||No adjustment made for multiple comparisons.|Longitudinal mixed effect analysis|||Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.||-1.78|-4.76|<0.0001
72592659|NCT01210495|144716433|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.74|||<|0.0001|TWO_SIDED|95.0|-5.26|-2.21||No adjustment made for multiple comparisons.|Longitudinal mixed effect analysis|||Analysis presented above is for FACT-G PWB. Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.||-2.21|-5.26|<0.0001
72592660|NCT01210495|144716433|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.27||||0.1642|TWO_SIDED|95.0|-3.07|0.52||No adjustment made for multiple comparisons.|Longitudinal mixed effect analysis|||Analysis presented above is for FACT-G SWB. Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.||0.52|-3.07|0.1642
72592661|NCT01210495|144716433|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.48||||0.4759|TWO_SIDED|95.0|-1.8|0.84||No adjustment made for multiple comparisons.|Longitudinal mixed effect analysis|||Analysis presented above is for FACT-G EWB. Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.||0.84|-1.80|0.4759
72592662|NCT01210495|144716433|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.07||||0.0288|TWO_SIDED|95.0|-3.92|-0.21||No adjustment made for multiple comparisons.|Longitudinal mixed effect analysis|||Analysis presented above is for FACT-G FWB. Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.||-0.21|-3.92|0.0288
72592663|NCT01210495|144716434|SUPERIORITY||Mean Difference (Final Values)|-4.96||||0.0011|TWO_SIDED|95.0|-7.93|-1.99||No adjustment made for multiple comparisons.|Longitudinal mixed effect analysis|||Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.||-1.99|-7.93|0.0011
72592664|NCT01210495|144716435|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.45|||<|0.0001|TWO_SIDED|95.0|-15.49|-5.42||No adjustment made for multiple comparisons.|Longitudinal mixed effect analysis|||Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.||-5.42|-15.49|<0.0001
72592665|NCT01210495|144716436|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.252||||0.9182|TWO_SIDED|95.0|0.923|1.698||The p-value is from a 1-sided log-rank test.|1-sided, unstratified log-rank test||Assuming proportional hazards, a hazard ratio \<1 indicates reduction in hazard rate to favor Axitinib, hazard ratio \>1 indicates reduction to favor Placebo.|||1.698|0.923|0.9182
72592666|NCT01210495|144716437|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.12||||0.0024|TWO_SIDED|95.0|-0.2|-0.04|||Longitudinal mixed effect analysis|||Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.||-0.04|-0.20|0.0024
72592667|NCT01210495|144716438|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.03||||0.0193|TWO_SIDED|95.0|-12.91|-1.15|||Longitudinal mixed effect analysis|||Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.||-1.15|-12.91|0.0193
72592668|NCT00454818|144716454|SUPERIORITY_OR_OTHER|||||||0.078||||||The a priori threshold for statistical significance was P \< 0.2. There were no adjustments for multiple comparisons.|t-test, 2 sided|||||||0.078
72592669|NCT00454818|144716454|SUPERIORITY_OR_OTHER|||||||0.515||||||The a priori threshold for statistical significance was P \< 0.2. There were no adjustments for multiple comparisons.|t-test, 2 sided|||||||0.515
72592670|NCT00454818|144716454|SUPERIORITY_OR_OTHER|||||||0.098||||||The a priori threshold for statistical significance was P \< 0.2. There were no adjustments for multiple comparisons.|t-test, 2 sided|||||||0.098
72592671|NCT00767039|144716472|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0||||Tested null hypothesis. T-test and Generalized Linear Model was used to assess respiratory support parameters (mean airway pressure and percent fraction of inspiratory oxygen x mean airway pressure).|t-test, 2 sided|||Respiratory support were compared using a t-test for individual time points and Generalized Linear Model to account for correlations among repeated measures. Patient who survive \>/= 3 days were included in the analysis.||||< 0.05
72592672|NCT00767039|144716473|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.43|||<|0.05|TWO_SIDED|95.0|0.19|0.95|||Mantel Haenszel|||||0.95|0.19|<0.05
72592673|NCT00767039|144716474|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0|||||t-test, 2 sided|||Tested null hypothesis. T-test and Generalized Linear Model was used to assess respiratory support parameters (mean airway pressure and percent fraction of inspiratory oxygen x mean airway pressure).||||<0.05
72592674|NCT00767039|144716475|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.49|||<|0.05|TWO_SIDED|95.0|0.25|0.96|||Mantel Haenszel|||||0.96|0.25|<0.05
72421568|NCT05383417|144354269|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
72592675|NCT00767039|144716476|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|2.38|||<|0.01|TWO_SIDED|95.0|1.29|4.38|||Mantel Haenszel|||||4.38|1.29|<0.01
72592676|NCT00767039|144716477|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||t-test, 2 sided|||||||>0.05
72421569|NCT05383417|144354270|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
72421570|NCT01932697|144354276|SUPERIORITY|||||||0.01|||||||Paired t-test|||||||.01
72421571|NCT01932697|144354277|SUPERIORITY||||||<|0.001|||||||Paired t-test|||||||<0.001
72421572|NCT01932697|144354278|SUPERIORITY||||||<|0.001|||||||Paired t-test|||||||<0.001
72421573|NCT01932697|144354279|SUPERIORITY||||||<|0.001|||||||Paired t-test|||||||<0.001
72592677|NCT00767039|144716478|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||t-test, 2 sided|||Tested null hypothesis. T-test and Generalized Linear Model was used to assess respiratory support parameters (mean airway pressure and percent fraction of inspiratory oxygen x mean airway pressure).||||<0.05
72592678|NCT00767039|144716479|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||t-test, 2 sided|||Tested null hypothesis. T-test and Generalized Linear Model was used to assess respiratory support parameters (mean airway pressure and percent fraction of inspiratory oxygen x mean airway pressure).||||<0.05
72592679|NCT00767039|144716480|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED|95.0|||||t-test, 2 sided|||||||<0.01
72421574|NCT01226511|144354282|SUPERIORITY_OR_OTHER||Least squares (LS) mean difference|-2.65|STANDARD_ERROR_OF_MEAN|0.7|<|0.001|TWO_SIDED|95.0|-4.03|-1.27|||Mixed Models Analysis|||||-1.27|-4.03|<0.001
72421575|NCT01337986|144354296|SUPERIORITY_OR_OTHER_LEGACY|||||||0.84|||||||Mixed Models Analysis|||Per protocol Analysis||||0.84
72592680|NCT00767039|144716481|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.44|||>|0.05|TWO_SIDED|95.0|0.71|2.89|||Mantel Haenszel|||||2.89|0.71|>0.05
72592681|NCT00767039|144716482|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.48|||>|0.05|TWO_SIDED|90.0|0.84|2.63|||Mantel Haenszel|||||2.63|0.84|>0.05
72592682|NCT01472757|144716498|SUPERIORITY|||||||0.013|||||||ANCOVA|||||||0.013
72592683|NCT01472757|144716498|SUPERIORITY||||||<|0.001||||||Calculated p-value was less than 0.001.|ANCOVA|||||||<0.001
72592684|NCT01472757|144716498|SUPERIORITY||||||<|0.001||||||Calculated p-value was less than 0.001.|ANCOVA|||||||<0.001
72421576|NCT01337986|144354296|SUPERIORITY_OR_OTHER_LEGACY|||||||0.29|||||||Mixed Models Analysis|||Change in EDTRS between Visits 2 and 3.||||.29
72592685|NCT01472757|144716499|SUPERIORITY|||||||0.001|||||||Fisher Exact|||||||0.001
72592686|NCT01472757|144716499|SUPERIORITY|||||||0.006|||||||Fisher Exact|||||||0.006
72592687|NCT01472757|144716499|SUPERIORITY|||||||0.011|||||||Fisher Exact|||||||0.011
72592688|NCT01472757|144716500|SUPERIORITY|||||||0.002|||||||ANCOVA|||||||0.002
72592689|NCT01472757|144716500|SUPERIORITY|||||||0.002|||||||ANCOVA|||||||0.002
72592690|NCT01472757|144716500|SUPERIORITY|||||||0.008|||||||ANCOVA|||||||0.008
72592691|NCT02961062|144716514|SUPERIORITY||Mean Difference (Final Values)|-11.1|STANDARD_ERROR_OF_MEAN|0.0||0.005|TWO_SIDED|90.0|-17.54|-4.71|||Kenward-Roger method|||||-4.71|-17.54|0.005
72592692|NCT02961062|144716515|SUPERIORITY||Median Difference (Final Values)|-8.56|STANDARD_ERROR_OF_MEAN|3.37||0.017|TWO_SIDED|90.0|-14.29|-2.83|||Kenward-Roger method|||||-2.83|-14.29|0.017
72592693|NCT01777568|144716544|SUPERIORITY||Risk Ratio (RR)|0.99||||0.85|TWO_SIDED|95.0|0.85|1.14|||GEE model||Relative Risk: 80% (numerator) vs. 30% (denominator)|||1.14|0.85|0.85
72592694|NCT01777568|144716545|SUPERIORITY||Risk Ratio (RR)|0.8||||0.047|TWO_SIDED|95.0|0.66|1.01|||Chi-squared|||||1.01|0.66|0.047
72592695|NCT00844480|144716546|SUPERIORITY|||||||0.03|||||||t-test, 2 sided|||||||.03
72592696|NCT00478699|144716580|SUPERIORITY||Hazard Ratio (HR)|0.946||||0.73|TWO_SIDED|95.0|0.689|1.298|||Log Rank|||Based on the relevant clinical evidence of the prognostic and predictive value of BRCA1, proposes the present study with which it is intended to demonstrate that adjuvant chemotherapy Individualized based on BRCA1 expression (Experimental arm), it is more effective than chemotherapy without individualize based (Control arm) in patients with completely resected stage II-IIIA NSCLC.||1.298|0.689|0.73
72592697|NCT00478699|144716581|SUPERIORITY||Median Difference (Final Values)|79.3||||0.753|TWO_SIDED|95.0|63.5|95.1|||Log Rank|||Control Arm v Experimental Arm||95.1|63.5|0.753
72592698|NCT00478699|144716581|SUPERIORITY|The initial hyphotesis were the disease free survival were longest under 65 vs upper 65.|Median Difference (Final Values)|38.7||||0.025|TWO_SIDED|95.0|28.0|38.7|||Log Rank|||Control Arm v Experimental Arm||38.7|28|0.025
72592699|NCT01005888|144716583|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0||||Observed number of attacks.|ANOVA|||||||<0.0001
72592700|NCT01005888|144716583|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0||||Normalized number of attacks.|ANOVA|||||||<0.0001
72592701|NCT01005888|144716584|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.999||95.0||||Period 1.|Fisher Exact|||||||>0.999
72592702|NCT01005888|144716584|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.999||95.0||||Period 2.|Fisher Exact|||||||>0.999
72592703|NCT01005888|144716585|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0008||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0008
72592704|NCT01005888|144716586|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0004||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0004
72592705|NCT01005888|144716587|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.0001
72592706|NCT01005888|144716588|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.0001
72592707|NCT01005888|144716589|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0||||Visit 1 change at 1 hour post-infusion.|Wilcoxon (Mann-Whitney)|||||||<0.0001
72592708|NCT01005888|144716589|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0||||Week 4 change at 1 hour post-infusion.|Wilcoxon (Mann-Whitney)|||||||<0.0001
72592709|NCT01005888|144716589|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0001||95.0||||Week 8 change at 1 hour post-infusion.|Wilcoxon (Mann-Whitney)|||||||0.0001
72592710|NCT01005888|144716589|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0028||95.0||||Week 12 change at 1 hour post-infusion.|Wilcoxon (Mann-Whitney)|||||||0.0028
72592711|NCT01005888|144716590|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0||||Visit 1 percent change at 1 hour post-infusion.|Wilcoxon (Mann-Whitney)|||||||<0.0001
72592712|NCT01005888|144716590|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0||||Week 4 percent change at 1 hour post-infusion.|Wilcoxon (Mann-Whitney)|||||||<0.0001
72592713|NCT01005888|144716590|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0||||Week 8 percent change at 1 hour post-infusion.|Wilcoxon (Mann-Whitney)|||||||<0.0001
72592714|NCT01005888|144716590|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0002||95.0||||Week 12 percent change at 1 hour post-infusion.|Wilcoxon (Mann-Whitney)|||||||0.0002
72592715|NCT01043705|144716591|SUPERIORITY_OR_OTHER||One sided Fisher's exact test.|0.0044||||0.0023|ONE_SIDED|95.0||0.009|||Fisher Exact|||||0.009||0.0023
72592716|NCT01043705|144716591|SUPERIORITY_OR_OTHER||1-sided Fisher's Exact Text|0.002||||0.0052|ONE_SIDED|95.0||0.01|||Fisher Exact|||||0.01||0.0052
72592717|NCT01043705|144716591|SUPERIORITY_OR_OTHER||1-sided Fisher's Exact Test|0.006||||0.0176|ONE_SIDED|95.0||0.014|||Fisher Exact|||||0.014||0.0176
72592718|NCT01043705|144716591|SUPERIORITY_OR_OTHER||Fisher's Exact Test|0.7||||0.3764|TWO_SIDED|95.0|||||Fisher Exact|||||||0.3764
72592719|NCT01043705|144716592|SUPERIORITY_OR_OTHER||Rate compared to performance goal|4.4||||0.0005|TWO_SIDED|95.0|3.3|5.8|||1-sided Chi-square|||||5.8|3.3|0.0005
72592720|NCT01043705|144716592|SUPERIORITY_OR_OTHER||Rate compared to a performance goal|3.1||||0.0444|TWO_SIDED|95.0|1.7|5.1|||1-sided Chi-square test|||||5.1|1.7|0.0444
72592721|NCT01043705|144716592|SUPERIORITY_OR_OTHER||rate compared to performance goal|5.4||||0.0006|TWO_SIDED|95.0|3.8|5.4|||1-sided Chi-squared test|||All types of mechanical complications combined.||5.4|3.8|0.0006
72592722|NCT01043705|144716592|SUPERIORITY_OR_OTHER||Descriptive|5.4||||0.0745|TWO_SIDED|95.0|3.7|7.5|||Chi-squared|||All mechanical complications, retrospective, non-TYRX cohort||7.5|3.7|0.0745
72592723|NCT00347919|144716607|SUPERIORITY_OR_OTHER||Percentage difference|2.7||||0.3724||90.0|-11.0|16.3|||Chi-squared||Difference in the percentage of independently-evaluated PD between lapatinib and combination therapy (lapatinib plus pazopanib)|||16.3|-11.0|0.3724
72592724|NCT00347919|144716607|SUPERIORITY_OR_OTHER||Percentage difference|5.4||||0.2578||90.0|-8.4|19.2|||Chi-squared||Difference in the percentage of investigator-evaluated PD between lapatinib and combination therapy (lapatinib plus pazopanib)|||19.2|-8.4|0.2578
72592725|NCT00347919|144716608|SUPERIORITY_OR_OTHER|||||||0.7488||95.0|||||Log Rank|||||||0.7488
72592726|NCT03379753|144716623|OTHER||U statistic|984.5||||0.57|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.57
72592727|NCT01032239|144716624|SUPERIORITY||Hodges-Lehmann|-0.667||||0.014|TWO_SIDED|95.1|-1.0|-0.1667|||Wilcoxon (Mann-Whitney)|||To test the null hypothesis the sample size needed was 44 evaluable patient (22 per arm) with a power of 80 %.||-0.1667|-1.000|0.0140
72592728|NCT01032239|144716625|SUPERIORITY||Hodges-Lehmann|-0.6||||0.0042|TWO_SIDED|95.0|-1.0|-0.2|||Wilcoxon (Mann-Whitney)|||||-0.2000|-1.0000|0.0042
72592729|NCT01032239|144716626|SUPERIORITY|||||||0.054|||||||Wilcoxon (Mann-Whitney)|||||||0.0540
72592730|NCT01032239|144716627|SUPERIORITY|||||||0.6256|||||||Wilcoxon (Mann-Whitney)|||||||0.6256
72592731|NCT01032239|144716628|SUPERIORITY|||||||0.3676|||||||Cochran-Mantel-Haenszel|||||||0.3676
72592732|NCT01032239|144716629|SUPERIORITY|||||||0.038|||||||Wilcoxon (Mann-Whitney)|||Actual Pain||||0.0380
72592733|NCT01032239|144716629|SUPERIORITY|||||||0.0136|||||||Wilcoxon (Mann-Whitney)|||Least Pain||||0.0136
72592734|NCT01032239|144716629|SUPERIORITY|||||||0.2427|||||||Wilcoxon (Mann-Whitney)|||Worst Pain||||0.2427
72592735|NCT01032239|144716630|SUPERIORITY|||||||0.7661|||||||Fisher Exact|||||||0.7661
72592736|NCT01032239|144716631|SUPERIORITY|||||||0.0197|||||||Wilcoxon (Mann-Whitney)|||Utility Score||||0.0197
72592737|NCT01032239|144716631|SUPERIORITY|||||||0.3807|||||||t-test, 2 sided|||VAS||||0.3807
72592738|NCT01032239|144716632|SUPERIORITY|||||||0.1068|||||||t-test, 2 sided|||PCS||||0.1068
72592739|NCT01032239|144716632|SUPERIORITY|||||||0.6824|||||||t-test, 2 sided|||MCS||||0.6824
72592740|NCT01032239|144716633|SUPERIORITY|||||||0.2105|||||||t-test, 2 sided|||||||0.2105
72592741|NCT02426749|144716653|OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
72592742|NCT01565369|144716695|SUPERIORITY_OR_OTHER||Fleiss' kappa|0.8547|STANDARD_ERROR_OF_MEAN|0.0282|<|0.0001||95.0||||evaluated at the .05 significance level|Fleiss' kappa|||Fleiss' kappa||||<0.0001
72592743|NCT02754674|144716707|SUPERIORITY|||||||0.008|||||||t-test, 2 sided|||||||0.008
72592744|NCT02754674|144716708|SUPERIORITY||||||>|0.05|||||||Chi-squared|||||||>0.05
72592745|NCT02754674|144716709|SUPERIORITY|Student's t-test or the Mann-Whitney U-test was used to analyze intergroup differences. The paired t-test or Wilcoxon signed rank test was used to analyze differences between pre- and postoperative values. The statistical significance level was set at .05.|||||>|0.05|||||||t-test, 2 sided|||We used the Kolmogorov-Smirnov test to assess the normality of the data distribution. Student's t-test or the Mann-Whitney U-test was used to analyze intergroup differences. The paired t-test or Wilcoxon signed rank test was used to analyze differences between pre- and postoperative values. Pearson's Chi-square test or Fisher's exact test was used to analyze categorical variables between groups. The statistical significance level was set at .05.||||>0.05
72592746|NCT02754674|144716710|SUPERIORITY||||||>|0.05|||||||t-test, 2 sided|||||||>0.05
72592747|NCT02754674|144716711|SUPERIORITY|||||||0.054|||||||t-test, 2 sided|||||||0.054
72592748|NCT02135107|144716722|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Chi-squared|P-value was calculated using chi-square test at two-sided significance level of alpha = 0.05.||||||<0.001
72592749|NCT02135107|144716723|SUPERIORITY||||||<|0.001|||||||Chi-squared|P-value was calculated using chi-square test at a two-sided significance level of alpha = 0.05.||Comparison at Week 12||||<0.001
72592750|NCT02135107|144716723|SUPERIORITY||||||<|0.001|||||||Chi-squared|P-value was calculated using chi-square test at two-sided significance level of alpha = 0.05.||Comparison at Week 24||||<0.001
72592751|NCT02135107|144716724|SUPERIORITY||Hazard Ratio (HR)|0.34|||<|0.001|TWO_SIDED|95.0|0.23|0.49|||Log Rank|||||0.49|0.23|<0.001
72592752|NCT02135107|144716725|SUPERIORITY||Group difference|-15.2|||<|0.001|TWO_SIDED|95.0|-23.5|-6.8|||Chi-squared|P-value was calculated using chi-square test at two-sided significance level of alpha = 0.05.|Group difference (percentage of participants) = Arm D (percentage of participants) - Arm C (percentage of participants) 95% CI was calculated based on normal approximation.|||-6.8|-23.5|<0.001
72592753|NCT02135107|144716728|SUPERIORITY||Group difference|0.0|||=|0.992|TWO_SIDED|95.0|-3.5|3.5||P-value was calculated using chi-square test at two-sided significance level of alpha = 0.05.|Chi-squared||Group difference (percentage of participants) = Arm D (percentage of participants) - Arm C (percentage of participants) 95% CI was calculated based on normal approximation.|||3.5|-3.5|=0.992
72592754|NCT00808639|144716769|SUPERIORITY_OR_OTHER||Pathologic response rate|49.0|||||TWO_SIDED|80.0|38.0|61.0||||||This study used a Simon's optimal two-stage design. Of 39 eligible patients, if 18 achieved PaR, the treatment would be declared effective. A two-sided 80% CI was estimated considering the two-stage design based on Atkinson and Brown methods.||61|38|
72414607|NCT01581281|144339432|SUPERIORITY||Median Difference (Final Values)|-0.64||||0.4143|TWO_SIDED|98.3|-2.52|1.24||Each comparison was tested using a Bonferroni corrected significance level of 0.017 (0.05/3).|Regression, Linear|||Another major secondary objective was to determine if the change in absolute headache days from baseline to week 24 differed between treatment groups. This objective was assessed using linear regression models, with three pairwise comparisons between treatment groups (Amitriptyline vs. Placebo, Topiramate vs. Placebo, and Amitriptyline vs. Topiramate). The models, and corresponding odds ratios, were adjusted for the two stratification variables (age and baseline number of headache days).||1.24|-2.52|0.4143
72414608|NCT01581281|144339432|SUPERIORITY||Median Difference (Final Values)|-0.08||||0.9038|TWO_SIDED|98.3|-1.68|1.52||Each comparison was tested using a Bonferroni corrected significance level of 0.017 (0.05/3).|Regression, Linear|||Another major secondary objective was to determine if the change in absolute headache days from baseline to week 24 differed between treatment groups. This objective was assessed using linear regression models, with three pairwise comparisons between treatment groups (Amitriptyline vs. Placebo, Topiramate vs. Placebo, and Amitriptyline vs. Topiramate). The models, and corresponding odds ratios, were adjusted for the two stratification variables (age and baseline number of headache days).||1.52|-1.68|0.9038
72421577|NCT01337986|144354298|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.008|STANDARD_ERROR_OF_MEAN|0.01||0.64|TWO_SIDED|95.0|||||Mixed Models Analysis|||Null hypothesis: there will be no difference in the change relevant to baseline (visit 1) in EDTRS 5% contrast sensitivity with dalfampridine vs placebo.||||.64
72592755|NCT02266472|144716772|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based on 2-sided 90% CIs for the ratios (test to reference treatment) of the adjusted gMeans of the primary endpoints, with acceptance range of 80.00 to 125.00 %.|ratio of the adjusted means|99.11|STANDARD_DEVIATION|6.3|<|0.0001|TWO_SIDED|90.0|96.4|101.89|||ANOVA|ANOVA model on the logarithmic scale including random effects for 'subjects within sequences' \& fixed effect for 'sequence', 'period' \& 'treatment'.|Relative bioavailability of empagliflozin was estimated by the adjusted gMean ratio of Fed 10mg+1000mg FDC divided by Fed 10mg+1000mg Single. Standard deviation is actually intraindividual geometric coefficient variation (gCV).|||101.89|96.40|<0.0001
72592756|NCT02266472|144716773|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based on 2-sided 90% confidence intervals (CIs) for the ratios (test to reference treatment) of the adjusted geometric means (gMeans) of the primary endpoints,using an acceptance range of 80.00 to 125.00 %.|ratio of the adjusted means|101.25|STANDARD_DEVIATION|10.7|<|0.0001|TWO_SIDED|90.0|96.54|106.19|||ANOVA|ANOVA model on the logarithmic scale including random effects for 'subjects within sequences' \& fixed effect for 'sequence', 'period' \& 'treatment'.|Relative bioavailability of metformin was estimated by the adjusted gMean ratio of Fed 10mg+1000mg FDC divided by Fed 10mg+1000mg Single. Standard deviation is actually intraindividual geometric coefficient variation (gCV).|||106.19|96.54|<0.0001
72592757|NCT02266472|144716774|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based on 2-sided 90% CIs for the ratios (test to reference treatment) of the adjusted gMeans of the primary endpoints, with acceptance range of 80.00 to 125.00%.|ratio of the adjusted means|99.12|STANDARD_DEVIATION|12.9|<|0.0001|TWO_SIDED|90.0|93.69|104.87|||ANOVA|ANOVA model on the logarithmic scale including random effects for 'subjects within sequences' \& fixed effect for 'sequence', 'period' \& 'treatment'.|Relative bioavailability of empagliflozin was estimated by the adjusted gMean ratio of Fed10mg+1000mg FDC divided by Fed10mg+1000mg Single. Standard deviation is actually intraindividual geometric coefficient variation (gCV).|||104.87|93.69|<0.0001
72592758|NCT02266472|144716775|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based on 2-sided 90% CIs for the ratios (test to reference treatment) of the adjusted gMeans of the primary endpoints, with acceptance range of 80.00 to 125.00%.|ratio of the adjusted means|108.58|STANDARD_DEVIATION|9.3|<|0.0001|TWO_SIDED|90.0|104.17|113.17|||ANOVA|ANOVA model on the logarithmic scale including random effects for 'subjects within sequences' \& fixed effect for 'sequence', 'period' \& 'treatment'.|Relative bioavailability of metformin was estimated by the adjusted gMean ratio of Fed10mg+1000mg FDC divided by Fed10mg+1000mg Single. Standard deviation is actually intraindividual geometric coefficient variation (gCV).|||113.17|104.17|<0.0001
72592759|NCT02266472|144716776|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based on 2-sided 90% CIs for the ratios (test to reference treatment) of the adjusted gMeans of the primary endpoints, with acceptance range of 80.00 to 125.00%.|ratio of the adjusted means|98.89|STANDARD_DEVIATION|6.3|||TWO_SIDED|90.0|96.18|101.67|||ANOVA|ANOVA model on the logarithmic scale including random effects for 'subjects within sequences' \& fixed effect for 'sequence', 'period' \& 'treatment'.|Relative bioavailability of empagliflozin was estimated by the adjusted gMean ratio of Fed10mg+1000mg FDC divided by Fed10mg+1000mg Single. Standard deviation is actually intraindividual geometric coefficient variation (gCV).|||101.67|96.18|
72592760|NCT02266472|144716777|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based on 2-sided 90% CIs for the ratios (test to reference treatment) of the adjusted gMeans of the primary endpoints, with acceptance range of 80.00 to 125.00%.|ratio of the adjusted means|101.37|STANDARD_DEVIATION|11.0|||TWO_SIDED|90.0|96.53|106.45|||ANOVA|ANOVA model on the logarithmic scale including random effects for 'subjects within sequences' \& fixed effect for 'sequence', 'period' \& 'treatment'.|Relative bioavailability of metformin was estimated by the adjusted gMean ratio of Fed10mg+1000mg FDC divided by Fed10mg+1000mg Single. Standard deviation is actually intraindividual geometric coefficient variation (gCV).|||106.45|96.53|
72414609|NCT01581281|144339433|SUPERIORITY||Odds Ratio (OR)|2.07||||0.1557|TWO_SIDED|95.0|0.85|5.05|||Fisher Exact|||Tolerability was assessed by calculating the percent of subjects who completed the entire 24 week treatment period and the corresponding 95% confidence intervals for each treatment group. Concerns regarding tolerability would be raised if the upper bound of a confidence interval was less than 65% or if the percent of subjects who completed the entire 24 week treatment period in either of the active treatment groups was significantly less than the placebo group.||5.05|0.85|0.1557
72592761|NCT03055494|144716780|OTHER|Statistical hypothesis tests were not performed in this study|difference in percentages|76.1|||||TWO_SIDED|95.0|63.3|88.8|||95% confidence interval|"Statistical analysis of no response of skin histology/K16 expression to treatment at Week 12"|||"A patient with missing assessment was considered as having a yes response of skin histology/K16 expression to treatment regardless of the reason for missing data (eg, premature study discontinuation, missed visit, administrative issues). However, missing baseline value was not imputed."|88.8|63.3|
72592762|NCT03055494|144716781|OTHER|Statistical hypothesis tests were not performed in this study|difference in percentages|55.8|||||TWO_SIDED|95.0|42.3|69.3|||95% confidence interval|||||69.3|42.3|
72592763|NCT05897827|144716798|OTHER|We calculated the mean and 95% confidence interval using a one sample two-sided t-test against the a priori benchmark of success, which was \> 3.75.|Mean|3.93||||0.074|TWO_SIDED|95.0|3.73|4.13||Threshold for statistical significance: \<0.05|t-test, 2 sided|||||4.13|3.73|0.074
72592764|NCT05897827|144716799|OTHER|We calculated the mean and 95% confidence interval using a one sample two-sided t-test against the a priori benchmark of success, which was \> 75.|Mean|75.47||||0.827|TWO_SIDED|95.0|71.12|79.83||Threshold for statistical significance: \<0.05|t-test, 2 sided|||||79.83|71.12|0.827
72592765|NCT05897827|144716800|OTHER|We calculated the mean and 95% confidence interval using a one sample two-sided t-test against the a priori benchmark of success, which was \> 3.75.|Mean|4.01||||0.003|TWO_SIDED|95.0|3.84|4.17||Threshold for statistical significance: \<0.05|t-test, 2 sided|||||4.17|3.84|0.003
72592766|NCT05897827|144716801|OTHER|We calculated the mean and 95% confidence interval using a one sample two-sided t-test against the a priori benchmark of success, which was \> 3.75.|Mean|4.01||||0.002|TWO_SIDED|95.0|3.85|4.18||Threshold for statistical significance: \<0.05|t-test, 2 sided|||||4.18|3.85|0.002
72592767|NCT05897827|144716805|OTHER|To test for within-arm statistical significance, we used linear mixed models accounting for within-person clustering using random effects. We reported the beta coefficients and 95% confidence intervals.|Mean Difference (Net)|0.22||||0.03|TWO_SIDED|95.0|0.03|0.42||Threshold for statistical significance: \<0.05|Mixed Models Analysis|||||0.42|0.03|0.03
72592768|NCT05897827|144716805|OTHER|To test for within-arm statistical significance, we used linear mixed models accounting for within-person clustering using random effects. We reported the beta coefficients and 95% confidence intervals.|Mean Difference (Net)|0.01||||0.95|TWO_SIDED|95.0|-0.36|0.38||Threshold for statistical significance: \<0.05|Mixed Models Analysis|||||0.38|-0.36|0.95
72592769|NCT05897827|144716806|OTHER|To test for within-arm statistical significance of the change in Self-Efficacy in LGBTQ+ Inclusivity, Awareness, and Advocacy, we used linear mixed models accounting for within-person clustering using random effects. We reported the beta coefficients and 95% confidence intervals.|Mean Difference (Net)|0.7|||<|0.001|TWO_SIDED|95.0|0.46|0.95||Threshold for statistical significance: \<0.05|Mixed Models Analysis|||||0.95|0.46|<0.001
72592770|NCT05897827|144716806|OTHER|To test for within-arm statistical significance of the change in Self-Efficacy in LGBTQ+ Inclusivity, Awareness, and Advocacy, we used linear mixed models accounting for within-person clustering using random effects. We reported the beta coefficients and 95% confidence intervals.|Mean Difference (Net)|0.45||||0.01|TWO_SIDED|95.0|0.1|0.8||Threshold for statistical significance: \<0.05|Mixed Models Analysis|||||0.80|0.10|0.01
72592771|NCT05897827|144716806|OTHER|To test for within-arm statistical significance of the change in Self-Efficacy in Identity-Affirming Practices, we used linear mixed models accounting for within-person clustering using random effects. We reported the beta coefficients and 95% confidence intervals.|Mean Difference (Net)|0.26||||0.001|TWO_SIDED|95.0|0.11|0.41||Threshold for statistical significance: \<0.05|Mixed Models Analysis|||||0.41|0.11|0.001
72592772|NCT05897827|144716806|OTHER|To test for within-arm statistical significance of the change in Self-Efficacy in Identity-Affirming Practices, we used linear mixed models accounting for within-person clustering using random effects. We reported the beta coefficients and 95% confidence intervals.|Mean Difference (Net)|0.13||||0.01|TWO_SIDED|95.0|0.03|0.24||Threshold for statistical significance: \<0.05|Mixed Models Analysis|||||0.24|0.03|0.01
72592773|NCT05897827|144716806|OTHER|To test for within-arm statistical significance of the change in Self-Efficacy in Inclusivity in Restrooms and Changing Options, we used linear mixed models accounting for within-person clustering using random effects. We reported the beta coefficients and 95% confidence intervals.|Mean Difference (Net)|0.43||||0.001|TWO_SIDED|95.0|0.18|0.68||Threshold for statistical significance: \<0.05|Mixed Models Analysis|||||0.68|0.18|0.001
72592774|NCT05897827|144716806|OTHER|To test for within-arm statistical significance of the change in Self-Efficacy in Inclusivity in Restrooms and Changing Options, we used linear mixed models accounting for within-person clustering using random effects. We reported the beta coefficients and 95% confidence intervals.|Mean Difference (Net)|0.44||||0.04|TWO_SIDED|95.0|0.02|0.86||Threshold for statistical significance: \<0.05|Mixed Models Analysis|||||0.86|0.02|0.04
72414610|NCT01581281|144339433|SUPERIORITY||Odds Ratio (OR)|2.31||||0.0754|TWO_SIDED|95.0|0.95|5.62|||Fisher Exact|||Tolerability was assessed by calculating the percent of subjects who completed the entire 24 week treatment period and the corresponding 95% confidence intervals for each treatment group. Concerns regarding tolerability would be raised if the upper bound of a confidence interval was less than 65% or if the percent of subjects who completed the entire 24 week treatment period in either of the active treatment groups was significantly less than the placebo group.||5.62|0.95|0.0754
72414611|NCT01581281|144339433|SUPERIORITY||Odds Ratio (OR)|0.89||||0.7611|TWO_SIDED|95.0|0.49|1.62|||Fisher Exact|||Tolerability was assessed by calculating the percent of subjects who completed the entire 24 week treatment period and the corresponding 95% confidence intervals for each treatment group. Concerns regarding tolerability would be raised if the upper bound of a confidence interval was less than 65% or if the percent of subjects who completed the entire 24 week treatment period in either of the active treatment groups was significantly less than the placebo group.||1.62|0.49|0.7611
72414612|NCT01581281|144339434|SUPERIORITY|||||||0.3038|||||||Fisher Exact|||The occurrence of treatment-related SAE's was assessed in two ways: 1) percentage of subjects who experience any treatment-related SAE in each of the three groups was compared using Fishers exact test; 2) rates of treatment-emergent SAS's across the three groups were compared using a Poisson regression model. However, due to the small number of SAEs that were deemed treatment-emergent (4 in AMI, 1 in TPM, 0 in PBO), the parameter estimates did not converge for the Poisson regression model.||||0.3038
72592775|NCT05897827|144716807|OTHER|To test for within-arm statistical significance of the change in Notice the Event, we used linear mixed models accounting for within-person clustering using random effects. We reported the beta coefficients and 95% confidence intervals.|Mean Difference (Net)|-0.23||||0.1|TWO_SIDED|95.0|-0.5|0.04||Threshold for statistical significance: \<0.05|Mixed Models Analysis|||||0.04|-0.50|0.10
72592776|NCT05897827|144716807|OTHER|To test for within-arm statistical significance of the change in Notice the Event, we used linear mixed models accounting for within-person clustering using random effects. We reported the beta coefficients and 95% confidence intervals.|Mean Difference (Net)|-0.24||||0.14|TWO_SIDED|95.0|-0.55|0.07||Threshold for statistical significance: \<0.05|Mixed Models Analysis|||||0.07|-0.55|0.14
72592777|NCT05897827|144716807|OTHER|To test for within-arm statistical significance of the change in Interpret the Event as an Emergency, we used linear mixed models accounting for within-person clustering using random effects. We reported the beta coefficients and 95% confidence intervals.|Mean Difference (Net)|-0.19||||0.07|TWO_SIDED|95.0|-0.39|0.01||Threshold for statistical significance: \<0.05|Mixed Models Analysis|||||0.01|-0.39|0.07
72592778|NCT05897827|144716807|OTHER|To test for within-arm statistical significance of the change in Interpret the Event as an Emergency, we used linear mixed models accounting for within-person clustering using random effects. We reported the beta coefficients and 95% confidence intervals.|Mean Difference (Net)|0.02||||0.85|TWO_SIDED|95.0|-0.18|0.22||Threshold for statistical significance: \<0.05|Mixed Models Analysis|||||0.22|-0.18|0.85
72592779|NCT05897827|144716807|OTHER|To test for within-arm statistical significance of the change in Accept Responsibility for Intervening, we used linear mixed models accounting for within-person clustering using random effects. We reported the beta coefficients and 95% confidence intervals.|Mean Difference (Net)|-0.15||||0.06|TWO_SIDED|95.0|-0.3|0.01||Threshold for statistical significance: \<0.05|Mixed Models Analysis|||||0.01|-0.30|0.06
72592780|NCT05897827|144716807|OTHER|To test for within-arm statistical significance of the change in Accept Responsibility for Intervening, we used linear mixed models accounting for within-person clustering using random effects. We reported the beta coefficients and 95% confidence intervals.|Mean Difference (Net)|0.07||||0.51|TWO_SIDED|95.0|-0.14|0.28||Threshold for statistical significance: \<0.05|Mixed Models Analysis|||||0.28|-0.14|0.51
72592781|NCT05897827|144716807|OTHER|To test for within-arm statistical significance of the change in Know How to Intervene, we used linear mixed models accounting for within-person clustering using random effects. We reported the beta coefficients and 95% confidence intervals.|Mean Difference (Net)|0.33||||0.001|TWO_SIDED|95.0|0.13|0.53||Threshold for statistical significance: \<0.05|Mixed Models Analysis|||||0.53|0.13|0.001
72592782|NCT05897827|144716807|OTHER|To test for within-arm statistical significance of the change in Know How to Intervene, we used linear mixed models accounting for within-person clustering using random effects. We reported the beta coefficients and 95% confidence intervals.|Mean Difference (Net)|0.28||||0.04|TWO_SIDED|95.0|0.01|0.55||Threshold for statistical significance: \<0.05|Mixed Models Analysis|||||0.55|0.01|0.04
72414613|NCT01581281|144339434|SUPERIORITY|||||||1|||||||Fisher Exact|||The occurrence of treatment-related SAE's was assessed in two ways: 1) percentage of subjects who experience any treatment-related SAE in each of the three groups was compared using Fishers exact test; 2) rates of treatment-emergent SAS's across the three groups were compared using a Poisson regression model. However, due to the small number of SAEs that were deemed treatment-emergent (4 in AMI, 1 in TPM, 0 in PBO), the parameter estimates did not converge for the Poisson regression model.||||1.000
72592783|NCT05897827|144716807|OTHER|To test for within-arm statistical significance of the change in Implement Intervention Decisions, we used linear mixed models accounting for within-person clustering using random effects. We reported the beta coefficients and 95% confidence intervals.|Mean Difference (Net)|-0.06||||0.36|TWO_SIDED|95.0|-0.19|0.07||Threshold for statistical significance: \<0.05|Mixed Models Analysis|||||0.07|-0.19|0.36
72592784|NCT05897827|144716807|OTHER|To test for within-arm statistical significance of the change in Implement Intervention Decisions, we used linear mixed models accounting for within-person clustering using random effects. We reported the beta coefficients and 95% confidence intervals.|Mean Difference (Net)|-0.03||||0.62|TWO_SIDED|95.0|-0.16|0.1||Threshold for statistical significance: \<0.05|Mixed Models Analysis|||||0.10|-0.16|0.62
72592785|NCT05897827|144716808|OTHER|To test for within-arm statistical significance of the change in Notice the Event, we used linear mixed models accounting for within-person clustering using random effects. We reported the beta coefficients and 95% confidence intervals.|Mean Difference (Net)|-0.15||||0.08|TWO_SIDED|95.0|-0.32|0.02||Threshold for statistical significance: \<0.05|Mixed Models Analysis|||||0.02|-0.32|0.08
72592786|NCT05897827|144716808|OTHER|To test for within-arm statistical significance of the change in Notice the Event, we used linear mixed models accounting for within-person clustering using random effects. We reported the beta coefficients and 95% confidence intervals.|Mean Difference (Net)|-0.21||||0.2|TWO_SIDED|95.0|-0.55|0.12||Threshold for statistical significance: \<0.05|Mixed Models Analysis|||||0.12|-0.55|0.20
72592787|NCT05897827|144716808|OTHER|To test for within-arm statistical significance of the change in Interpret the Event as an Emergency, we used linear mixed models accounting for within-person clustering using random effects. We reported the beta coefficients and 95% confidence intervals.|Mean Difference (Net)|-0.02||||0.74|TWO_SIDED|95.0|-0.14|0.1||Threshold for statistical significance: \<0.05|Mixed Models Analysis|||||0.10|-0.14|0.74
72592788|NCT05897827|144716808|OTHER|To test for within-arm statistical significance of the change in Interpret the Event as an Emergency, we used linear mixed models accounting for within-person clustering using random effects. We reported the beta coefficients and 95% confidence intervals.|Mean Difference (Net)|0.05||||0.55|TWO_SIDED|95.0|-0.12|0.23||Threshold for statistical significance: \<0.05|Mixed Models Analysis|||||0.23|-0.12|0.55
72592789|NCT05897827|144716808|OTHER|To test for within-arm statistical significance of the change in Accept Responsibility for Intervening, we used linear mixed models accounting for within-person clustering using random effects. We reported the beta coefficients and 95% confidence intervals.|Mean Difference (Net)|-0.07||||0.4|TWO_SIDED|95.0|-0.22|0.09||Threshold for statistical significance: \<0.05|Mixed Models Analysis|||||0.09|-0.22|0.40
72592790|NCT05897827|144716808|OTHER|To test for within-arm statistical significance of the change in Accept Responsibility for Intervening, we used linear mixed models accounting for within-person clustering using random effects. We reported the beta coefficients and 95% confidence intervals.|Mean Difference (Net)|-0.12||||0.36|TWO_SIDED|95.0|-0.37|0.13||Threshold for statistical significance: \<0.05|Mixed Models Analysis|||||0.13|-0.37|0.36
72592791|NCT05897827|144716808|OTHER|To test for within-arm statistical significance of the change in Know How to Intervene, we used linear mixed models accounting for within-person clustering using random effects. We reported the beta coefficients and 95% confidence intervals.|Mean Difference (Net)|0.39|||<|0.001|TWO_SIDED|95.0|0.18|0.6||Threshold for statistical significance: \<0.05|Mixed Models Analysis|||||0.60|0.18|<0.001
72592792|NCT05897827|144716808|OTHER|To test for within-arm statistical significance of the change in Know How to Intervene, we used linear mixed models accounting for within-person clustering using random effects. We reported the beta coefficients and 95% confidence intervals.|Mean Difference (Net)|0.12||||0.41|TWO_SIDED|95.0|-0.16|0.39||Threshold for statistical significance: \<0.05|Mixed Models Analysis|||||0.39|-0.16|0.41
72592793|NCT05897827|144716808|OTHER|To test for within-arm statistical significance of the change in Implement Intervention Decisions, we used linear mixed models accounting for within-person clustering using random effects. We reported the beta coefficients and 95% confidence intervals.|Mean Difference (Net)|-0.01||||0.92|TWO_SIDED|95.0|-0.22|0.2||Threshold for statistical significance: \<0.05|Mixed Models Analysis|||||0.20|-0.22|0.92
72592794|NCT05897827|144716808|OTHER|To test for within-arm statistical significance of the change in Implement Intervention Decisions, we used linear mixed models accounting for within-person clustering using random effects. We reported the beta coefficients and 95% confidence intervals.|Mean Difference (Net)|0.14||||0.37|TWO_SIDED|95.0|-0.16|0.44||Threshold for statistical significance: \<0.05|Mixed Models Analysis|||||0.44|-0.16|0.37
72592795|NCT05897827|144716809|OTHER|To test for within-arm statistical significance, we used linear mixed models accounting for within-person clustering using random effects. We reported the beta coefficients and 95% confidence intervals.|Mean Difference (Net)|0.44|||<|0.001|TWO_SIDED|95.0|0.28|0.59||Threshold for statistical significance: \<0.05|Mixed Models Analysis|||||0.59|0.28|<0.001
72592796|NCT05897827|144716809|OTHER|To test for within-arm statistical significance, we used linear mixed models accounting for within-person clustering using random effects. We reported the beta coefficients and 95% confidence intervals.|Mean Difference (Net)|0.49|||<|0.001|TWO_SIDED|95.0|0.29|0.69||Threshold for statistical significance: \<0.05|Mixed Models Analysis|||||0.69|0.29|<0.001
72592797|NCT00197002|144716811|NON_INFERIORITY_OR_EQUIVALENCE|"The two-sided standardized asymptotic 95% confidence interval (CI) for the difference in seropositivity rates \[Havrix+Prevnar Group minus Havrix Group\] was computed. The anti-HAV seropositivity rates in the Havrix+Prevnar Group were considered as non-inferior to the seropositivity rates in the Havrix Group, if the lower limit of the 95% CI was not lower (≥) than -5%.~The non-inferiority was concluded if both non-inferiority criteria (for seropositivity rates and GMCs) were met."|Difference in seropositivity rate|-1.06|||||TWO_SIDED|95.0|-5.78|2.45||||||"Difference in seropositivity rates for anti-HAV:~To demonstrate the non-inferiority of Havrix® vaccine co-administered with Prevnar™ vaccine (Havrix+Prevnar Group), compared to Havrix® vaccine administered alone (Havrix Group), in terms of seropositivity rates and geometric mean concentrations (GMCs) for anti-HAV antibody, one month after Dose 2 of Havrix® vaccine (Month 7-10)."||2.45|-5.78|
72414614|NCT01581281|144339434|SUPERIORITY|||||||0.2139|||||||Fisher Exact|||The occurrence of treatment-related SAE's was assessed in two ways: 1) percentage of subjects who experience any treatment-related SAE in each of the three groups was compared using Fishers exact test; 2) rates of treatment-emergent SAS's across the three groups were compared using a Poisson regression model. However, due to the small number of SAEs that were deemed treatment-emergent (4 in AMI, 1 in TPM, 0 in PBO), the parameter estimates did not converge for the Poisson regression model.||||0.2139
72414615|NCT05054816|144339541|SUPERIORITY||||||<|0.05||||||The p-value was adjusted for multiple comparisons between three conditions: investigative feature, comparative feature 1, comparative feature 2|ANOVA|The data were protected against deviations from sphericity by modifying degrees of freedom using Greenhouse-Geisser corrections.||Previous research with subjective ratings has repeatedly shown that data collected with 15-25 participants can yield significant results.||||<0.05
72414616|NCT05054816|144339542|SUPERIORITY||||||<|0.05||||||The p-value was adjusted for multiple comparisons between three conditions: investigative feature, comparative feature 1, comparative feature 2|ANOVA|The data were protected against deviations from sphericity by modifying degrees of freedom using Greenhouse-Geisser corrections||Previous research with subjective ratings has repeatedly shown that data collected with 15-25 participants can yield significant results.||||<0.05
72414617|NCT05054816|144339543|SUPERIORITY||||||<|0.05||||||The p-value was adjusted for multiple comparisons between three conditions: investigative feature, comparative feature 1, comparative feature 2|ANOVA|The data were protected against deviations from sphericity by modifying degrees of freedom using Greenhouse-Geisser corrections||Previous research with subjective ratings has repeatedly shown that data collected with 15-25 participants can yield significant results.||||<0.05
72414618|NCT05054816|144339544|SUPERIORITY||||||<|0.05||||||The p-value was adjusted for multiple comparisons between two conditions: investigative feature, comparative feature 1|ANOVA|The data were protected against deviations from sphericity by modifying degrees of freedom using Greenhouse-Geisser corrections||Previous research with subjective ratings has repeatedly shown that data collected with 15-25 participants can yield significant results.||||<0.05
72414619|NCT05054816|144339545|SUPERIORITY||||||<|0.05||||||The p-value was adjusted for multiple comparisons between three conditions: investigative feature, comparative feature 1, comparative feature 2|ANOVA|The data were protected against deviations from sphericity by modifying degrees of freedom using Greenhouse-Geisser corrections||Previous research with subjective ratings has repeatedly shown that data collected with 15-25 participants can yield significant results.||||<0.05
72414620|NCT02010060|144339643|SUPERIORITY|||||||0.074|||||||ANCOVA|||||||0.074
72414621|NCT02010060|144339643|SUPERIORITY|||||||0.684|||||||ANCOVA|||Change in waist circumference between AERO and CON||||0.684
72414622|NCT02010060|144339643|SUPERIORITY|||||||0.18|||||||ANCOVA|||Comparison between the AERO group and the AERO-PA group||||0.180
72414623|NCT02010060|144339644|SUPERIORITY|||||||0.011|||||||ANCOVA|||Change in body fat between the AERO-PA group and the CON group||||0.011
72414624|NCT02010060|144339644|SUPERIORITY|||||||0.16|||||||ANCOVA|||||||0.16
72414625|NCT02010060|144339644|SUPERIORITY|||||||0.258|||||||ANCOVA|||Change in body fat between the AERO and AERO-PA group||||0.258
72414626|NCT02010060|144339645|SUPERIORITY|||||||0.104|||||||ANCOVA|||Comparison of body weight between the CON and AERO-PA groups||||0.104
72414627|NCT02010060|144339645|SUPERIORITY|||||||0.578|||||||ANCOVA|||Change in body weight between the CON and AERO groups||||0.578
72414628|NCT02010060|144339645|SUPERIORITY|||||||0.3|||||||ANCOVA|||Change in body weight between the AERO and AERO-PA groups||||0.300
72414629|NCT02010060|144339646|SUPERIORITY|||||||0.002|||||||ANCOVA|||Change in cardiorespiratory fitness (L/min) between the AERO and AERO-PA groups||||0.002
72414630|NCT02010060|144339646|SUPERIORITY|||||||0.314|||||||ANCOVA|||Change in cardiorespiratory fitness (L/min) AERO and CON groups||||0.314
72414631|NCT02010060|144339646|SUPERIORITY|||||||0.041|||||||ANCOVA|||Change in cardiorespiratory fitness (L/min) between the AERO and AERO-PA groups||||0.041
72414632|NCT02010060|144339647|SUPERIORITY|||||||0.891|||||||ANCOVA|||Change in insulin sensitivity between the CON and AERO-PA groups||||0.891
72414633|NCT02010060|144339647|SUPERIORITY|||||||0.417|||||||ANCOVA|||Change in insulin sensitivity between the CON and AERO groups||||0.417
72592798|NCT00197002|144716812|NON_INFERIORITY_OR_EQUIVALENCE|"The standardized two-sided 95% CI for the GMC ratio (Havrix+Prevnar Group divided by Havrix Group) was computed. The anti-HAV GMC in the Havrix+Prevnar Group was considered as non-inferior to the anti-HAV GMC in the Havrix Group if the lower limit of the 95% CI was not lower than (≥) 0.5.~The non-inferiority of the anti-HAV immune response in Havrix+Prevnar Group compared to Havrix Group was concluded if both non-inferiority criteria (for seropositivity rates and GMCs) were met."|Adjusted GMC ratio|0.91|||||TWO_SIDED|95.0|0.63|1.31|||ANCOVA|||To demonstrate the non-inferiority of Havrix® vaccine co-administered with Prevnar™ vaccine (Havrix+Prevnar Group), compared to Havrix® vaccine administered alone (Havrix Group), in terms of seropositivity rates and geometric mean concentrations (GMCs) for anti-HAV antibody, one month after Dose 2 of Havrix® vaccine (Month 7-10).||1.31|0.63|
72592799|NCT02017717|144716830|SUPERIORITY||Hazard Ratio (HR)|1.1||||0.3791|TWO_SIDED|95.0|0.89|1.36|||log-rank test stratified|||||1.36|0.89|0.3791
72592800|NCT02017717|144716831|SUPERIORITY||Difference of OS rates at 12 months|-0.5||||0.9208|TWO_SIDED|95.0|-10.8|9.7|||Z test with variance estimation based on|Greenwood formula using log(-log) transformation||||9.7|-10.8|0.9208
72592801|NCT02017717|144716833|SUPERIORITY||Hazard Ratio (HR)|1.88|||||TWO_SIDED|95.0|1.5|2.35||||||||2.35|1.50|
72592802|NCT02017717|144716834|SUPERIORITY||Odds Ratio (OR)|0.29|||||TWO_SIDED|95.0|0.15|0.59||||||||0.59|0.15|
72592803|NCT02017717|144716835|SUPERIORITY||Hazard Ratio (HR)|1.1||||0.3791|TWO_SIDED|95.0|0.89|1.36|||log-rank test stratified|||||1.36|0.89|0.3791
72592804|NCT02276053|144716846|OTHER||Retention rate|86.0|||||TWO_SIDED|95.0|79.0|93.1|||||"Confidence intervals for the 6-month retention rate were calculated using Greenwood's formula.~Addition of a note: Not all patients had an Observation Period of 6 months."|The retention rate was derived using Kaplan-Meier methodology where patients who completed the study were censored at the date of last administration of LCM in the study.||93.1|79.0|
72592805|NCT04542499|144716871|SUPERIORITY||LS Mean of Difference|1.103|STANDARD_ERROR_OF_MEAN|0.28|<|0.0001|TWO_SIDED|95.0|0.553|1.653||LS Means, SE, difference from placebo, and confidence intervals are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, and treatment by visit interaction and baseline as a covariate.|Mixed-effect Model Repeated Measurement|||||1.653|0.553|<0.0001
72592806|NCT04542499|144716872|SUPERIORITY||LS Mean of Difference|-0.943|STANDARD_ERROR_OF_MEAN|0.271||0.0006|TWO_SIDED|95.0|-1.475|-0.41||LS Means, SE, difference from placebo, and confidence intervals are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, and treatment by visit interaction and baseline as a covariate.|Mixed-effect Model Repeated Measurement|||||-0.410|-1.475|0.0006
72592807|NCT04542499|144716873|SUPERIORITY||LS Mean of Difference|-0.23|STANDARD_ERROR_OF_MEAN|0.188||0.2216|TWO_SIDED|95.0|-0.6|0.139||LS Means, SE, difference from placebo, and confidence intervals are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, and treatment by visit interaction and baseline as a covariate.|Mixed-effect Model Repeated Measurement|||Week 2||0.139|-0.600|0.2216
72592808|NCT04542499|144716873|SUPERIORITY||LS Mean of Difference|0.099|STANDARD_ERROR_OF_MEAN|0.211||0.6379|TWO_SIDED|95.0|-0.316|0.515||LS Means, SE, difference from placebo, and confidence intervals are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, and treatment by visit interaction and baseline as a covariate.|Mixed-effect Model Repeated Measurement|||Week 5||0.515|-0.316|0.6379
72592809|NCT04542499|144716873|SUPERIORITY||LS Mean of Difference|0.582|STANDARD_ERROR_OF_MEAN|0.234||0.0132|TWO_SIDED|95.0|0.122|1.042||LS Means, SE, difference from placebo, and confidence intervals are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, and treatment by visit interaction and baseline as a covariate.|Mixed-effect Model Repeated Measurement|||Week 8||1.042|0.122|0.0132
72592810|NCT04542499|144716873|SUPERIORITY||LS Mean of Difference|0.358|STANDARD_ERROR_OF_MEAN|0.236||0.1299|TWO_SIDED|95.0|-0.106|0.821||LS Means, SE, difference from placebo, and confidence intervals are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, and treatment by visit interaction and baseline as a covariate.|Mixed-effect Model Repeated Measurement|||Week 11||0.821|-0.106|0.1299
72592811|NCT04542499|144716873|SUPERIORITY||LS Mean of Difference|0.698|STANDARD_ERROR_OF_MEAN|0.257||0.0068|TWO_SIDED|95.0|0.194|1.202||LS Means, SE, difference from placebo, and confidence intervals are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, and treatment by visit interaction and baseline as a covariate.|Mixed-effect Model Repeated Measurement|||Week 14||1.202|0.194|0.0068
72592812|NCT04542499|144716873|SUPERIORITY||LS Mean of Difference|0.969|STANDARD_ERROR_OF_MEAN|0.254||0.0002|TWO_SIDED|95.0|0.469|1.469||LS Means, SE, difference from placebo, and confidence intervals are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, and treatment by visit interaction and baseline as a covariate.|Mixed-effect Model Repeated Measurement|||Week 18||1.469|0.469|0.0002
72592813|NCT04542499|144716873|SUPERIORITY||LS Mean of Difference|0.879|STANDARD_ERROR_OF_MEAN|0.259||0.0008|TWO_SIDED|95.0|0.369|1.389||LS Means, SE, difference from placebo, and confidence intervals are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, and treatment by visit interaction and baseline as a covariate.|Mixed-effect Model Repeated Measurement|||Week 22||1.389|0.369|0.0008
72414634|NCT02010060|144339647|SUPERIORITY|||||||0.484|||||||ANCOVA|||Change in insulin sensitivity between the AERO and AERO-PA groups||||0.484
72592814|NCT04542499|144716873|SUPERIORITY||LS Mean of Difference|1.103|STANDARD_ERROR_OF_MEAN|0.28|<|0.0001|TWO_SIDED|95.0|0.553|1.653||LS Means, SE, difference from placebo, and confidence intervals are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, and treatment by visit interaction and baseline as a covariate.|Mixed-effect Model Repeated Measurement|||Week 26||1.653|0.553|<0.0001
72414635|NCT02010060|144339648|SUPERIORITY|||||||0.274|||||||ANCOVA|||Change in Low density lipoprotein (LDL) between the CON and the AERO groups||||0.274
72414636|NCT02010060|144339648|SUPERIORITY|||||||0.461|||||||ANCOVA|||Change in Low density lipoprotein (LDL) between the CON and AERO groups||||0.461
72592815|NCT04542499|144716874|SUPERIORITY||LS Mean of Difference|0.108|STANDARD_ERROR_OF_MEAN|0.18||0.5471|TWO_SIDED|95.0|-0.245|0.461||LS Means, SE, difference from placebo, and confidence intervals are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, and treatment by visit interaction and baseline as a covariate.|Mixed-effect Model Repeated Measurement|||Week 2||0.461|-0.245|0.5471
72592816|NCT04542499|144716874|SUPERIORITY||LS Mean of Difference|-0.237|STANDARD_ERROR_OF_MEAN|0.205||0.2488|TWO_SIDED|95.0|-0.64|0.166||LS Means, SE, difference from placebo, and confidence intervals are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, and treatment by visit interaction and baseline as a covariate.|Mixed-effect Model Repeated Measurement|||Week 5||0.166|-0.640|0.2488
72592817|NCT04542499|144716874|SUPERIORITY||LS Mean of Difference|-0.818|STANDARD_ERROR_OF_MEAN|0.221||0.0002|TWO_SIDED|95.0|-1.252|-0.384||LS Means, SE, difference from placebo, and confidence intervals are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, and treatment by visit interaction and baseline as a covariate.|Mixed-effect Model Repeated Measurement|||Week 8||-0.384|-1.252|0.0002
72592818|NCT04542499|144716874|SUPERIORITY||LS Mean of Difference|-0.753|STANDARD_ERROR_OF_MEAN|0.227||0.001|TWO_SIDED|95.0|-1.199|-0.307||LS Means, SE, difference from placebo, and confidence intervals are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, and treatment by visit interaction and baseline as a covariate.|Mixed-effect Model Repeated Measurement|||Week 11||-0.307|-1.199|0.0010
72592819|NCT04542499|144716874|SUPERIORITY||LS Mean of Difference|-0.904|STANDARD_ERROR_OF_MEAN|0.254||0.0004|TWO_SIDED|95.0|-1.403|-0.405||LS Means, SE, difference from placebo, and confidence intervals are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, and treatment by visit interaction and baseline as a covariate.|Mixed-effect Model Repeated Measurement|||Week 14||-0.405|-1.403|0.0004
72592820|NCT04542499|144716874|SUPERIORITY||LS Mean of Difference|-1.024|STANDARD_ERROR_OF_MEAN|0.256|<|0.0001|TWO_SIDED|95.0|-1.528|-0.52||LS Means, SE, difference from placebo, and confidence intervals are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, and treatment by visit interaction and baseline as a covariate.|Mixed-effect Model Repeated Measurement|||Week 18||-0.520|-1.528|<0.0001
72592821|NCT04542499|144716874|SUPERIORITY||LS Mean of Difference|-0.979|STANDARD_ERROR_OF_MEAN|0.261||0.0002|TWO_SIDED|95.0|-1.493|-0.465||LS Means, SE, difference from placebo, and confidence intervals are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, and treatment by visit interaction and baseline as a covariate.|Mixed-effect Model Repeated Measurement|||Week 22||-0.465|-1.493|0.0002
72592822|NCT04542499|144716874|SUPERIORITY||LS Mean of Difference|-0.943|STANDARD_ERROR_OF_MEAN|0.271||0.0006|TWO_SIDED|95.0|-1.475|-0.41||LS Means, SE, difference from placebo, and confidence intervals are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, and treatment by visit interaction and baseline as a covariate.|Mixed-effect Model Repeated Measurement|||Week 26||-0.410|-1.475|0.0006
72592823|NCT04542499|144716875|SUPERIORITY||LS Mean of Difference|0.4|STANDARD_ERROR_OF_MEAN|0.4||0.3265|TWO_SIDED|95.0|-0.4|1.2||LS Means, SE, difference from placebo, and confidence intervals are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, and treatment by visit interaction and baseline as a covariate.|Mixed-effect Model Repeated Measurement|||Part I||1.2|-0.4|0.3265
72592824|NCT04542499|144716875|SUPERIORITY||LS Mean of Difference|-1.2|STANDARD_ERROR_OF_MEAN|0.52||0.0203|TWO_SIDED|95.0|-2.2|-0.2||LS Means, SE, difference from placebo, and confidence intervals are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, and treatment by visit interaction and baseline as a covariate.|Mixed-effect Model Repeated Measurement|||Part II||-0.2|-2.2|0.0203
72592825|NCT04542499|144716875|SUPERIORITY||LS Mean of Difference|-2.4|STANDARD_ERROR_OF_MEAN|0.96||0.0118|TWO_SIDED|95.0|-4.3|-0.5||LS Means, SE, difference from placebo, and confidence intervals are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, and treatment by visit interaction and baseline as a covariate.|Mixed-effect Model Repeated Measurement|||Part III||-0.5|-4.3|0.0118
72592826|NCT05711381|144716876|OTHER|PK parameters of HM15912 from the severe renal impairment group (Cohort 2) were to be estimated and compared to the control group (Cohort 1, normal renal function). A one-way analysis of variance (ANOVA) was to be used to compare log transformed PK parameters. The estimates of mean difference and corresponding 90% CIs, as well as each exponentiation of estimates, were to be presented to provide the estimates of GMR.|Geometric mean ratio|0.91|||||TWO_SIDED|90.0|0.59|1.41||||||||1.41|0.59|
72592827|NCT05711381|144716877|OTHER|PK parameters of HM15912 from the severe renal impairment group (Cohort 2) were to be estimated and compared to the control group (Cohort 1, normal renal function). A one-way analysis of variance (ANOVA) was to be used to compare log transformed PK parameters. The estimates of mean difference and corresponding 90% CIs, as well as each exponentiation of estimates, were to be presented to provide the estimates of GMR.|Geometric mean ratio|1.25|||||TWO_SIDED|90.0|0.93|1.68||||||||1.68|0.93|
72592828|NCT02407132|144716879|SUPERIORITY|||||||0.038||||||The p-value above reflects results of between-arms analysis of mean change in HbA1c from baseline to immediate post-intervention. 6 months between-arms p-value = 0.139; 12 months between-arms p-value = 0.013. Analyses do not include imputed values.|Linear mixed effects regression|Adjusted for baseline sex, age, education, marital status, employment, use of diabetes medication, and households containing multiple participants.||The outcome variable for these analyses is Change in mean HbA1c from baseline to immediate post-intervention, 6 months post-intervention, and 12 months post-intervention.||||0.038
72414637|NCT02010060|144339648|SUPERIORITY|||||||0.739|||||||ANCOVA|||Change in Low density lipoprotein (LDL) between AERO and AERO-PA groups||||0.739
72414638|NCT02010060|144339649|SUPERIORITY|||||||0.837|||||||ANCOVA|||Change in high density lipoprotein (HDL) between the CON and AERO-PA group||||0.837
72414639|NCT02010060|144339649|SUPERIORITY|||||||0.895|||||||ANCOVA|||Change in high density lipoprotein (HDL) between the CON and AERO groups||||0.895
72414640|NCT02010060|144339649|SUPERIORITY|||||||0.744|||||||ANCOVA|||||||0.744
72414641|NCT02010060|144339650|SUPERIORITY|||||||0.067|||||||ANCOVA|||Change in total cholesterol (mg/dL)||||0.067
72592829|NCT02407132|144716880|SUPERIORITY|||||||0.234||||||The p-value above reflects results of between-arms analysis of change in mean BMI from baseline to immediate post-intervention. 6 months between-arms p-value = 0.552; 12 months between-arms p-value = 0.447. Analyses do not include imputed values.|Linear mixed effects regression|Adjusted for baseline sex, age, education, marital status, employment, use of diabetes medication, and households containing multiple participants.||The outcome variable for these analyses is Change in mean BMI from baseline to immediate post-intervention, 6 months post-intervention, and 12 months post-intervention.||||0.234
72592830|NCT02407132|144716881|SUPERIORITY|||||||0.019||||||The p-value above reflects results of between-arms analysis of change in mean total chol from baseline to immediate post-intervention. 6 months between-arms p-value=0.598; 12 months between-arms p-value=0.073. Analyses do not include imputed values.|Linear mixed effects regression|Adjusted for baseline sex, age, education, marital status, employment, use of diabetes medication, and households containing multiple participants.||The outcome variable for these analyses is Change in mean Total Cholesterol (mg/dL) from baseline to immediate post-intervention, 6 months post-intervention, and 12 months post-intervention.||||0.019
72592831|NCT02407132|144716882|SUPERIORITY|||||||0.186||||||The p-value above reflects results of between-arms analysis of mean change in HDL from baseline to immediate post-intervention. 6 months between-arms p-value=0.009; 12 months between-arms p-value=0.201. Analyses do not include imputed values.|Linear mixed effects regression|Adjusted for baseline sex, age, education, marital status, employment, use of diabetes medication, and households containing multiple participants.||The outcome variable for these analyses is Change in mean HDL (mg/dL) from baseline to immediate post-intervention, 6 months post-intervention, and 12 months post-intervention.||||0.186
72592832|NCT02407132|144716883|SUPERIORITY|||||||0.04||||||The p-value above represents results of analysis of the between-arm changes in probability of performing the self-care behavior from baseline to 12 months post-intervention. Analyses do not include imputed values.|Mixed effects logistic regression|Adjusted for baseline sex, age, education, marital status, employment, use of diabetes medication, and households containing multiple participants.||To facilitate interpretation of regression coefficients, estimates obtained in the logit scale (log odds) were transformed into probability scale.||||0.040
72592833|NCT02407132|144716884|SUPERIORITY|||||||0.312||||||The p-value above represents results of analysis of the between-arm changes in probability of performing the self-care behavior from baseline to 12 months post-intervention. Analyses do not include imputed values.|Mixed Effects Logistic Regression|Adjusted for baseline sex, age, education, marital status, employment, use of diabetes medication, and households containing multiple participants.||To facilitate interpretation of regression coefficients, estimates obtained in the logit scale (log odds) were transformed into probability scale.||||0.312
72592834|NCT02407132|144716885|SUPERIORITY|||||||0.622||||||The p-value above represents results of analysis of the between-arm changes in probability of performing the self-care behavior from baseline to 12 months post-intervention. Analyses do not include imputed values.|Mixed effects logistic regression|Adjusted for baseline sex, age, education, marital status, employment, use of diabetes medication, and households containing multiple participants.||To facilitate interpretation of regression coefficients, estimates obtained in the logit scale (log odds) were transformed into probability scale.||||0.622
72592835|NCT02407132|144716886|SUPERIORITY|||||||0.957||||||The p-value above represents results of analysis of the between-arm changes in probability of performing the self-care behavior from baseline to 12 months post-intervention. Analyses do not include imputed values.|Mixed effects logistic regression|Adjusted for baseline sex, age, education, marital status, employment, use of diabetes medication, and households containing multiple participants.||To facilitate interpretation of regression coefficients, estimates obtained in the logit scale (log odds) were transformed into probability scale.||||0.957
72592836|NCT02407132|144716887|SUPERIORITY|||||||0.147||||||The p-value above represents results of analysis of the between-arm changes in probability of performing the self-care behavior from baseline to 12 months post-intervention. Analyses do not include imputed values.|Mixed effects logistic regression|Adjusted for baseline sex, age, education, marital status, employment, use of diabetes medication, and households containing multiple participants.||To facilitate interpretation of regression coefficients, estimates obtained in the logit scale (log odds) were transformed into probability scale.||||0.147
72592837|NCT02407132|144716888|SUPERIORITY|||||||0.326||||||The p-value above represents results of analysis of the between-arm changes in probability of performing the self-care behavior from baseline to 12 months post-intervention. Analyses do not include imputed values.|Mixed effects logistic regression|Adjusted for baseline sex, age, education, marital status, employment, use of diabetes medication, and households containing multiple participants.||To facilitate interpretation of regression coefficients, estimates obtained in the logit scale (log odds) were transformed into probability scale.||||0.326
72592838|NCT03617861|144716892|SUPERIORITY|||||||0.12|||||||Wilcoxon (Mann-Whitney)|||Healthy Controls Secretin vs Healthy Controls Placebo||||0.12
72592839|NCT03617861|144716892|SUPERIORITY|||||||0.65|||||||Wilcoxon (Mann-Whitney)|||Functional Dyspepsia Secretin vs Functional Dyspepsia Placebo||||0.65
72592840|NCT03617861|144716892|SUPERIORITY|||||||0.0574|||||||ANCOVA|||Healthy Controls vs Functional Dyspepsia||||0.0574
72592841|NCT03617861|144716893|SUPERIORITY|||||||0.85|||||||Wilcoxon (Mann-Whitney)|||Healthy Controls Secretin vs Healthy Controls Placebo||||0.85
72592842|NCT03617861|144716893|SUPERIORITY|||||||0.82|||||||Wilcoxon (Mann-Whitney)|||Functional Dyspepsia Secretin vs Functional Dyspepsia Placebo||||0.82
72592843|NCT03617861|144716893|SUPERIORITY|||||||0.1451|||||||ANCOVA|||Healthy Controls vs Functional Dyspepsia||||0.1451
72592844|NCT03617861|144716894|SUPERIORITY|||||||0.85|||||||Wilcoxon (Mann-Whitney)|||Healthy Controls Secretin vs Healthy Controls Placebo||||0.85
72592845|NCT03617861|144716894|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Functional Dyspepsia Secretin vs Functional Dyspepsia Placebo||||1.0
72414642|NCT02010060|144339650|SUPERIORITY|||||||0.254|||||||ANCOVA|||Change in total cholesterol (mg/dL) between the CON and AERO groups||||0.254
72414643|NCT02010060|144339650|SUPERIORITY|||||||0.501|||||||ANCOVA|||Change in total cholesterol (mg/dL) between AERO and AERO-PA groups||||0.501
72592846|NCT03617861|144716894|SUPERIORITY|||||||0.4233|||||||ANCOVA|||Healthy Controls vs Functional Dyspepsia||||0.4233
72592847|NCT03617861|144716895|SUPERIORITY|||||||0.92|||||||Wilcoxon (Mann-Whitney)|||Healthy Controls Secretin vs Healthy Controls Placebo||||0.92
72592848|NCT03617861|144716895|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Functional Dyspepsia Secretin vs Functional Dyspepsia Placebo||||1.0
72592849|NCT03617861|144716895|SUPERIORITY|||||||0.3891|||||||ANCOVA|||Healthy Controls vs Functional Dyspepsia||||0.3891
72592850|NCT03617861|144716896|SUPERIORITY|||||||0.004|||||||Wilcoxon (Mann-Whitney)|||Healthy Secretin vs Healthy Placebo||||0.004
72592851|NCT03617861|144716896|SUPERIORITY|||||||0.03|||||||Wilcoxon (Mann-Whitney)|||Functional Dyspepsia Secretin vs Functional Dyspepsia Placebo||||0.03
72592852|NCT03617861|144716896|SUPERIORITY|||||||0.0355|||||||ANCOVA|||Healthy vs Functional Dyspepsia||||0.0355
72592853|NCT03617861|144716897|SUPERIORITY|||||||0.5|||||||Wilcoxon (Mann-Whitney)|||Nausea: Healthy Controls Secretin vs Healthy Controls Placebo||||0.5
72592854|NCT03617861|144716897|SUPERIORITY|||||||0.16|||||||Wilcoxon (Mann-Whitney)|||Nausea: Functional Dyspepsia Secretin vs Functional Dyspepsia Placebo||||0.16
72592855|NCT03617861|144716897|SUPERIORITY|||||||0.0016|||||||ANCOVA|||Nausea: Healthy Controls vs Functional Dyspepsia||||0.0016
72414644|NCT02010060|144339651|SUPERIORITY|||||||0.456|||||||ANCOVA|||Change in triglyceride level between the AERO-PA and CON groups||||0.456
72592856|NCT03617861|144716897|SUPERIORITY|||||||0.1|||||||Wilcoxon (Mann-Whitney)|||Fullness: Healthy Controls Secretin vs Healthy Controls Placebo||||0.10
72592857|NCT03617861|144716897|SUPERIORITY|||||||0.3|||||||Wilcoxon (Mann-Whitney)|||Fullness: Functional Dyspepsia Secretin vs Functional Dyspepsia Placebo||||0.30
72592858|NCT03617861|144716897|SUPERIORITY|||||||0.0002|||||||ANCOVA|||Fullness: Healthy Controls vs Functional Dyspepsia||||0.0002
72592859|NCT03617861|144716897|SUPERIORITY|||||||0.41|||||||Wilcoxon (Mann-Whitney)|||Bloating: Healthy Controls Secretin vs Healthy Controls Placebo||||0.41
72592860|NCT03617861|144716897|SUPERIORITY|||||||0.67|||||||Wilcoxon (Mann-Whitney)|||Bloating Functional Dyspepsia Secretin vs Functional Dyspepsia Placebo||||0.67
72592861|NCT03617861|144716897|SUPERIORITY|||||||0.033|||||||ANCOVA|||Bloating: Healthy Controls vs Functional Dyspepsia||||0.0330
72592862|NCT03617861|144716897|SUPERIORITY|||||||0.25|||||||Wilcoxon (Mann-Whitney)|||Abdominal Pain: Healthy Controls Secretin vs Healthy Controls Placebo||||0.25
72592863|NCT03617861|144716897|SUPERIORITY|||||||0.57|||||||Wilcoxon (Mann-Whitney)|||Abdominal Pain: Functional Dyspepsia Secretin vs Functional Dyspepsia Placebo||||0.57
72414645|NCT02010060|144339651|SUPERIORITY|||||||0.422|||||||ANCOVA|||Change in triglyceride level between the CON and AERO groups||||0.422
72414646|NCT02010060|144339651|SUPERIORITY|||||||0.136|||||||ANCOVA|||Change in triglyceride level between the AERO and AERO-PA groups||||0.136
72592864|NCT03617861|144716897|SUPERIORITY|||||||0.2375|||||||ANCOVA|||Abdominal Pain: Healthy Controls vs Functional Dyspepsia||||0.2375
72592865|NCT01668966|144716917|SUPERIORITY_OR_OTHER|||||||0.101|||||||Paired t-test|||Statistical analysis at Week 12||||0.101
72592866|NCT01668966|144716917|SUPERIORITY_OR_OTHER|||||||0.139|||||||Paired t-test|||Statistical analysis at Week 24||||0.139
72592867|NCT01668966|144716917|SUPERIORITY_OR_OTHER|||||||0.116|||||||Paired t-test|||Statistical analysis at Week 36||||0.116
72592868|NCT01668966|144716917|SUPERIORITY_OR_OTHER|||||||0.167|||||||Paired t-test|||Statistical analysis at Week 48||||0.167
72592869|NCT01668966|144716917|SUPERIORITY_OR_OTHER|||||||0.21|||||||Paired t-test|||Statistical analysis at Week 56||||0.210
72592870|NCT01668966|144716917|SUPERIORITY_OR_OTHER|||||||0.343|||||||Paired t-test|||Statistical analysis at Week 68||||0.343
72592871|NCT01668966|144716917|SUPERIORITY_OR_OTHER|||||||0.533|||||||Paired t-test|||Statistical analysis at Week 80||||0.533
72592872|NCT01668966|144716917|SUPERIORITY_OR_OTHER|||||||0.593|||||||Paired t-test|||Statistical analysis at Week 92||||0.593
72592873|NCT01668966|144716917|SUPERIORITY_OR_OTHER|||||||0.044|||||||Paired t-test|||Statistical analysis at Week 104||||0.044
72592874|NCT01668966|144716917|SUPERIORITY_OR_OTHER|||||||0.243|||||||Paired t-test|||Statistical analysis at Follow-up visit 1||||0.243
72592875|NCT01668966|144716917|SUPERIORITY_OR_OTHER|||||||0.009|||||||Paired t-test|||Statistical analysis at Follow-up visit 2||||0.009
72592876|NCT01668966|144716918|SUPERIORITY_OR_OTHER|||||||0.1853|||||||Paired t-test|||Statistical analysis at Week 12||||0.1853
72592877|NCT01668966|144716918|SUPERIORITY_OR_OTHER|||||||0.2992|||||||Paired t-test|||Statistical analysis at Week 24||||0.2992
72592878|NCT01668966|144716918|SUPERIORITY_OR_OTHER|||||||0.2249|||||||Paired t-test|||Statistical analysis at Week 36||||0.2249
72592879|NCT01668966|144716918|SUPERIORITY_OR_OTHER|||||||0.3102|||||||Paired t-test|||Statistical analysis at Week 48||||0.3102
72592880|NCT01668966|144716918|SUPERIORITY_OR_OTHER|||||||0.2164|||||||Paired t-test|||Statistical analysis at Week 56||||0.2164
72592881|NCT01668966|144716918|SUPERIORITY_OR_OTHER|||||||0.8822|||||||Paired t-test|||Statistical analysis at Week 68||||0.8822
72592882|NCT01668966|144716918|SUPERIORITY_OR_OTHER|||||||0.7649|||||||Paired t-test|||Statistical analysis at Week 80||||0.7649
72592883|NCT01668966|144716918|SUPERIORITY_OR_OTHER|||||||0.605|||||||Paired t-test|||Statistical analysis at Week 92||||0.6050
72592884|NCT01668966|144716918|SUPERIORITY_OR_OTHER|||||||0.4478|||||||Paired t-test|||Statistical analysis at Week 104||||0.4478
72592885|NCT01668966|144716918|SUPERIORITY_OR_OTHER|||||||0.4821|||||||Paired t-test|||Statistical analysis at Follow-up visit 1||||0.4821
72592886|NCT01668966|144716918|SUPERIORITY_OR_OTHER|||||||0.0522|||||||Paired t-test|||Statistical analysis at Follow-up visit 2||||0.0522
72592887|NCT01668966|144716919|SUPERIORITY_OR_OTHER|||||||0.0624|||||||Paired t-test|||Statistical analysis at Week 12||||0.0624
72592888|NCT01668966|144716919|SUPERIORITY_OR_OTHER|||||||0.0616|||||||Paired t-test|||Statistical analysis at Week 24||||0.0616
72592889|NCT01668966|144716919|SUPERIORITY_OR_OTHER|||||||0.248|||||||Paired t-test|||Statistical analysis at Week 36||||0.2480
72414647|NCT02010060|144339652|SUPERIORITY|||||||0.483|||||||ANCOVA|||Change in glucose level between the CON and AERO-PA groups||||0.483
72592890|NCT01668966|144716919|SUPERIORITY_OR_OTHER|||||||0.5393|||||||Paired t-test|||Statistical analysis at Week 48||||0.5393
72592891|NCT01668966|144716919|SUPERIORITY_OR_OTHER|||||||0.1401|||||||Paired t-test|||Statistical analysis at Week 56||||0.1401
72592892|NCT01668966|144716919|SUPERIORITY_OR_OTHER|||||||0.0679|||||||Paired t-test|||Statistical analysis at Week 68||||0.0679
72592893|NCT01668966|144716919|SUPERIORITY_OR_OTHER|||||||0.6017|||||||Paired t-test|||Statistical analysis at Week 80||||0.6017
72592894|NCT01668966|144716919|SUPERIORITY_OR_OTHER|||||||0.4772|||||||Paired t-test|||Statistical analysis at Week 92||||0.4772
72592895|NCT01668966|144716919|SUPERIORITY_OR_OTHER|||||||0.4877|||||||Paired t-test|||Statistical analysis at Week 104||||0.4877
72592896|NCT01668966|144716919|SUPERIORITY_OR_OTHER|||||||0.0624|||||||Paired t-test|||Statistical analysis at Follow-up visit 1||||0.0624
72592897|NCT01668966|144716919|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Paired t-test|||Statistical analysis at Follow-up visit 2||||<0.0001
72592898|NCT01668966|144716920|SUPERIORITY_OR_OTHER|||||||0.2388|||||||Paired t-test|||Statistical analysis at Week 12||||0.2388
72592899|NCT01668966|144716920|SUPERIORITY_OR_OTHER|||||||0.1084|||||||Paired t-test|||Statistical analysis at Week 24||||0.1084
72592900|NCT01668966|144716920|SUPERIORITY_OR_OTHER|||||||0.0321|||||||Paired t-test|||Statistical analysis at Week 36||||0.0321
72592901|NCT01668966|144716920|SUPERIORITY_OR_OTHER|||||||0.0203|||||||Paired t-test|||Statistical analysis at Week 48||||0.0203
72592902|NCT01668966|144716920|SUPERIORITY_OR_OTHER|||||||0.0193|||||||Paired t-test|||Statistical analysis at Week 56||||0.0193
72592903|NCT01668966|144716920|SUPERIORITY_OR_OTHER|||||||0.6235|||||||Paired t-test|||Statistical analysis at Week 68||||0.6235
72592904|NCT01668966|144716920|SUPERIORITY_OR_OTHER|||||||0.2814|||||||Paired t-test|||Statistical analysis at Week 80||||0.2814
72592905|NCT01668966|144716920|SUPERIORITY_OR_OTHER|||||||0.3391|||||||Paired t-test|||Statistical analysis at Week 92||||0.3391
72592906|NCT01668966|144716920|SUPERIORITY_OR_OTHER|||||||0.1605|||||||Paired t-test|||Statistical analysis at Week 104||||0.1605
72592907|NCT01668966|144716920|SUPERIORITY_OR_OTHER|||||||0.4312|||||||Paired t-test|||Statistical analysis at Follow-up visit 2||||0.4312
72414648|NCT02010060|144339652|SUPERIORITY|||||||0.274|||||||ANCOVA|||Change in glucose between the CON and AERO groups||||0.274
72414649|NCT02010060|144339652|SUPERIORITY|||||||0.685|||||||ANCOVA|||Change in glucose level between the AERO and AERO-PA groups||||0.685
72414650|NCT02010060|144339653|SUPERIORITY|||||||0.489|||||||ANCOVA|||Change in systemic inflammation between CON and AERO-PA groups||||0.489
72414651|NCT02010060|144339653|SUPERIORITY|||||||0.652|||||||ANCOVA|||Change in systemic inflammation between the CON and AERO groups||||0.652
72592908|NCT01668966|144716923|SUPERIORITY_OR_OTHER|||||||0.934|||||||Paired t-test|||Statistical analysis at Week 12||||0.934
72592909|NCT01668966|144716923|SUPERIORITY_OR_OTHER|||||||0.624|||||||Paired t-test|||Statistical analysis at Week 24||||0.624
72592910|NCT01668966|144716923|SUPERIORITY_OR_OTHER|||||||0.642|||||||Paired t-test|||Statistical analysis at Week 36||||0.642
72592911|NCT01668966|144716923|SUPERIORITY_OR_OTHER|||||||0.952|||||||Paired t-test|||Statistical analysis at Week 48||||0.952
72592912|NCT01668966|144716923|SUPERIORITY_OR_OTHER|||||||0.928|||||||Paired t-test|||Statistical analysis at Week 56||||0.928
72592913|NCT01668966|144716923|SUPERIORITY_OR_OTHER|||||||0.832|||||||Paired t-test|||Statistical analysis at Week 68||||0.832
72592914|NCT01668966|144716923|SUPERIORITY_OR_OTHER|||||||0.315|||||||Paired t-test|||Statistical analysis at Week 80||||0.315
72592915|NCT01668966|144716923|SUPERIORITY_OR_OTHER|||||||0.485|||||||Paired t-test|||Statistical analysis at Week 92||||0.485
72592916|NCT01668966|144716923|SUPERIORITY_OR_OTHER|||||||0.246|||||||Paired t-test|||Statistical analysis at Week 104||||0.246
72592917|NCT01668966|144716923|SUPERIORITY_OR_OTHER|||||||0.375|||||||Paired t-test|||Statistical analysis at Follow-up visit 1||||0.375
72592918|NCT01668966|144716923|SUPERIORITY_OR_OTHER|||||||0.185|||||||Paired t-test|||Statistical analysis at Follow-up visit 2||||0.185
72592919|NCT01668966|144716924|SUPERIORITY_OR_OTHER|||||||0.445|||||||Paired t-test|||Statistical analysis at Week 12||||0.445
72592920|NCT01668966|144716924|SUPERIORITY_OR_OTHER|||||||0.414|||||||Paired t-test|||Statistical analysis at Week 24||||0.414
72592921|NCT01668966|144716924|SUPERIORITY_OR_OTHER|||||||0.401|||||||Paired t-test|||Statistical analysis at Week 36||||0.401
72592922|NCT01668966|144716924|SUPERIORITY_OR_OTHER|||||||0.92|||||||Paired t-test|||Statistical analysis at Week 48||||0.920
72592923|NCT01668966|144716924|SUPERIORITY_OR_OTHER|||||||0.834|||||||Paired t-test|||Statistical analysis at Week 56||||0.834
72592924|NCT01668966|144716924|SUPERIORITY_OR_OTHER|||||||0.539|||||||Paired t-test|||Statistical analysis at Week 68||||0.539
72592925|NCT01668966|144716924|SUPERIORITY_OR_OTHER|||||||0.246|||||||Paired t-test|||Statistical analysis at Week 80||||0.246
72592926|NCT01668966|144716924|SUPERIORITY_OR_OTHER|||||||0.602|||||||Paired t-test|||Statistical analysis at Week 92||||0.602
72592927|NCT01668966|144716924|SUPERIORITY_OR_OTHER|||||||0.218|||||||Paired t-test|||Statistical analysis at Week 104||||0.218
72592928|NCT01668966|144716924|SUPERIORITY_OR_OTHER|||||||0.208|||||||Paired t-test|||Statistical analysis at Follow-up visit 1||||0.208
72592929|NCT01668966|144716924|SUPERIORITY_OR_OTHER|||||||0.101|||||||Paired t-test|||Statistical analysis at Follow-up visit 2||||0.101
72592930|NCT01668966|144716925|SUPERIORITY_OR_OTHER|||||||0.565|||||||Paired t-test|||Statistical analysis at Week 12||||0.565
72592931|NCT01668966|144716925|SUPERIORITY_OR_OTHER|||||||0.637|||||||Paired t-test|||Statistical analysis at Week 24||||0.637
72414652|NCT02010060|144339653|SUPERIORITY|||||||0.822|||||||ANCOVA|||Change in systemic inflammation between the AERO and AERO-PA groups||||0.822
72592932|NCT01668966|144716925|SUPERIORITY_OR_OTHER|||||||0.594|||||||Paired t-test|||Statistical analysis at Week 36||||0.594
72592933|NCT01668966|144716925|SUPERIORITY_OR_OTHER|||||||0.788|||||||Paired t-test|||Statistical analysis at Week 48||||0.788
72592934|NCT01668966|144716925|SUPERIORITY_OR_OTHER|||||||0.329|||||||Paired t-test|||Statistical analysis at Week 56||||0.329
72592935|NCT01668966|144716925|SUPERIORITY_OR_OTHER|||||||0.716|||||||Paired t-test|||Statistical analysis at Week 68||||0.716
72592936|NCT01668966|144716925|SUPERIORITY_OR_OTHER|||||||0.119|||||||Paired t-test|||Statistical analysis at Week 80||||0.119
72592937|NCT01668966|144716925|SUPERIORITY_OR_OTHER|||||||0.201|||||||Paired t-test|||Statistical analysis at Week 92||||0.201
72592938|NCT01668966|144716925|SUPERIORITY_OR_OTHER|||||||0.087|||||||Paired t-test|||Statistical analysis at Week 104||||0.087
72592939|NCT01668966|144716925|SUPERIORITY_OR_OTHER|||||||0.116|||||||Paired t-test|||Statistical analysis at Follow-up visit 1||||0.116
72592940|NCT01668966|144716925|SUPERIORITY_OR_OTHER|||||||0.07|||||||Paired t-test|||Statistical analysis at Follow-up visit 2||||0.070
72414653|NCT02010060|144339654|SUPERIORITY||||||<|0.001|||||||ANCOVA|||Changes in steps between the CON group and the AERO-PA group||||<0.001
72592941|NCT01668966|144716926|SUPERIORITY_OR_OTHER|||||||0.3299|||||||Paired t-test|||Statistical analysis at Week 12||||0.3299
72592942|NCT01668966|144716926|SUPERIORITY_OR_OTHER|||||||0.9247|||||||Paired t-test|||Statistical analysis at Week 24||||0.9247
72592943|NCT01668966|144716926|SUPERIORITY_OR_OTHER|||||||0.9602|||||||Paired t-test|||Statistical analysis at Week 36||||0.9602
72592944|NCT01668966|144716926|SUPERIORITY_OR_OTHER|||||||0.2773|||||||Paired t-test|||Statistical analysis at Week 48||||0.2773
72592945|NCT01668966|144716926|SUPERIORITY_OR_OTHER|||||||0.5031|||||||Paired t-test|||Statistical analysis at Week 56||||0.5031
72592946|NCT01668966|144716926|SUPERIORITY_OR_OTHER|||||||0.8109|||||||Paired t-test|||Statistical analysis at Week 68||||0.8109
72592947|NCT01668966|144716926|SUPERIORITY_OR_OTHER|||||||0.254|||||||Paired t-test|||Statistical analysis at Week 80||||0.2540
72592948|NCT01668966|144716926|SUPERIORITY_OR_OTHER|||||||0.3794|||||||Paired t-test|||Statistical analysis at Week 92||||0.3794
72414654|NCT02010060|144339654|SUPERIORITY|||||||0.648|||||||ANCOVA|||Changes in steps between the CON and the AERO group||||0.648
72414655|NCT02010060|144339654|SUPERIORITY||||||<|0.001|||||||ANCOVA|||Changes in steps between the AERO and AERO-PA groups||||<0.001
72414656|NCT02010060|144339655|SUPERIORITY|||||||0.226|||||||ANCOVA|||Change in kilocalories (dietary intake) between CON and AERO-PA group||||0.226
72414657|NCT02010060|144339655|SUPERIORITY|||||||0.215|||||||ANCOVA|||Change in caloric intake between the CON and the AERO groups||||0.215
72592949|NCT01668966|144716926|SUPERIORITY_OR_OTHER|||||||0.8687|||||||Paired t-test|||Statistical analysis at Week 104||||0.8687
72592950|NCT01668966|144716926|SUPERIORITY_OR_OTHER|||||||0.4685|||||||Paired t-test|||Statistical analysis at Follow-up visit 1||||0.4685
72592951|NCT01668966|144716926|SUPERIORITY_OR_OTHER|||||||0.0511|||||||Paired t-test|||Statistical analysis at Follow-up visit 2||||0.0511
72592952|NCT01643798|144716968|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA|||||||<0.001
72592953|NCT01643798|144716968|SUPERIORITY_OR_OTHER|||||||0.04||95.0|||||ANOVA|||||||0.04
72592954|NCT01643798|144716969|SUPERIORITY_OR_OTHER|||||||0.0003||95.0|||||ANOVA|||||||.0003
72592955|NCT01643798|144716969|SUPERIORITY_OR_OTHER|||||||0.794||95.0|||||ANOVA|||||||0.794
72592956|NCT00614120|144717053|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is concluded if the two-sided upper limit of the 95% confidence interval for treatment difference in mean change in HbA1c between lira 1.8mg + met and glim + met is below 0.4%.|Estimated treatment difference, LS Mean|-0.06|||<|0.0001||95.0|-0.23|0.11||Non-inferiority; \<.0001. In order to protect the overall Type I error rate when testing for non-inferiority of the three doses of lira + met to glim + met, the comparisons will be invoked sequentially for descending doses of liraglutide.|ANCOVA|ANCOVA model with treatment, country and previous treatment as fixed effects and baseline value as a covariate.|The p-values correspond to one-sided hypotheses of either superiority or non-inferiority. Statistical significance on a 2.5% level.|"Based on standard normal theory, the sample size needed in order to be able to show that lira + met is non-inferior to glim + met when using a 1:1 randomisation and a non-inferiority criteria of 0.4% with a power of at least 85%, is tabulated below using different SD of HbA1c.~Assuming a drop out rate of 25%, the total number of subjects to be randomised is 896 (224 for each dose of the liraglutide + metformin group and 224 subjects in metformin+glimepiride treatment group) with a SD of 1.2%."||0.11|-0.23|<0.0001
72414658|NCT02010060|144339655|SUPERIORITY|||||||0.957|||||||ANCOVA|||Change in caloric intake (kilocalories) between the AERO and AERO-PA groups||||0.957
72414659|NCT02010060|144339656|SUPERIORITY|||||||0.337|||||||ANCOVA|||Change in insulin concentration between the CON and AERO-PA group||||0.337
72414660|NCT02010060|144339656|SUPERIORITY|||||||0.77|||||||ANCOVA|||Change in insulin level between the AERO and CON groups||||0.770
72414661|NCT02010060|144339656|SUPERIORITY|||||||0.515|||||||ANCOVA|||Change in insulin concentration between AERO and AERO-PA groups||||0.515
72414662|NCT03214367|144339667|NON_INFERIORITY|Noninferiority margin = 0.4% for HbA1c|LS Mean Difference|-0.08||||0.06|TWO_SIDED|95.0|-0.16|0.0|||Mixed Models Analysis|||||0.00|-0.16|0.060
72414663|NCT03214367|144339667|NON_INFERIORITY|Noninferiority margin = 0.4% for HbA1c|LS Mean Difference|0.13||||0.003|TWO_SIDED|95.0|0.04|0.22|||Mixed Models Analysis|||||0.22|0.04|0.003
72414664|NCT03214367|144339668|SUPERIORITY||LS Mean Difference|-27.9|||<|0.001|TWO_SIDED|95.0|-35.3|-20.6|||ANCOVA|||||-20.6|-35.3|<0.001
72414665|NCT03214367|144339668|SUPERIORITY||LS Mean Difference|13.2||||0.002|TWO_SIDED|95.0|5.0|21.4|||ANCOVA|||||21.4|5.0|0.002
72414666|NCT03214367|144339669|SUPERIORITY||LS Mean Difference|-31.2|||<|0.001|TWO_SIDED|95.0|-41.1|-21.2|||ANCOVA|||||-21.2|-41.1|<0.001
72414667|NCT03214367|144339669|SUPERIORITY||LS Mean Difference|-6.7||||0.235|TWO_SIDED|95.0|-17.6|4.3|||ANCOVA|||||4.3|-17.6|0.235
72414668|NCT03214367|144339678|SUPERIORITY||LS Mean Difference|-0.06||||0.184|TWO_SIDED|95.0|-0.16|0.03|||Mixed Models Analysis|||||0.03|-0.16|0.184
72414669|NCT03508843|144339679|SUPERIORITY||||||<|0.001|||||||McNemar|||||||<.001
72414670|NCT03508843|144339680|SUPERIORITY||||||<|0.001|||||||McNemar|||||||<.001
72414671|NCT03508843|144339681|SUPERIORITY||||||>|0.05|||||||McNemar|||||||>.05
72414672|NCT00765843|144339682|SUPERIORITY_OR_OTHER|||||||0.78|||||||ANOVA|||baseline comparisons||||0.78
72414673|NCT00765843|144339682|SUPERIORITY_OR_OTHER|||||||0.21|||||||ANOVA|||one month comparisons||||0.21
72414674|NCT00765843|144339682|SUPERIORITY_OR_OTHER|||||||0.93|||||||ANOVA|||three months comparisons||||0.93
72414675|NCT03555396|144339683|SUPERIORITY||Mean Difference (Final Values)|-3.54||||0.483|TWO_SIDED|95.0|-13.53|6.46|||t-test, 2 sided|||||6.46|-13.53|0.483
72414676|NCT03555396|144339684|SUPERIORITY|||||||0.637|||||||Chi-squared|||||||0.637
72414677|NCT03555396|144339685|SUPERIORITY||Mean Difference (Net)|9.54||||0.037|TWO_SIDED|95.0|0.59|18.49||Difference in mean change in adherence from baseline to 6 month follow-up between individuals in the intervention and control arms.|Mixed Models Analysis|Multilevel linear mixed model with random effects (dyad \& intercept); adjusting for participant age, sex, baseline adherence, and partner HIV status||||18.49|0.59|0.037
72414678|NCT03555396|144339686|SUPERIORITY|||||||0.621|||||||Chi-squared|Fisher's Exact Test used for small sample sizes||||||0.621
72414679|NCT04256733|144339687|SUPERIORITY|||||||0.23|||||||Mixed Models Analysis|||||||.23
72414680|NCT04256733|144339688|SUPERIORITY|||||||0.57|||||||Mixed Models Analysis|||||||.57
72414681|NCT04256733|144339689|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||||||<.0001
72414682|NCT04542343|144339690|OTHER||Mean Difference (Net)|3.0|||<|0.01|TWO_SIDED|95.0|2.246|3.754|||t-test, 2 sided|||||3.75400|2.24600|<0.01
72414683|NCT04542343|144339691|OTHER||Mean Difference (Net)|-3.3|||<|0.001|TWO_SIDED|95.0|-4.256785|-2.343215|||t-test, 2 sided|||||-2.343215|-4.256785|<0.001
72414684|NCT04542343|144339696|OTHER||Mean Difference (Net)|-0.21818|||<|0.01|TWO_SIDED|95.0|-0.36828|-0.06809|||t-test, 2 sided|||||-0.06809|-0.36828|<0.01
72414685|NCT04542343|144339697|OTHER||Mean Difference (Net)|0.05623|STANDARD_ERROR_OF_MEAN|0.026|<|0.05|TWO_SIDED|95.0|0.00459|0.10788|||t-test, 2 sided|||||0.10788|0.00459|<0.05
72414686|NCT01369342|144339700|SUPERIORITY_OR_OTHER||||||<|0.001||||||A fixed sequence testing procedure was used to control alpha at 0.05 over the outcome measures.|Cochran-Mantel-Haenszel chi-square test|2-sided Cochran-Mantel-Haenszel chi-square test, stratified by study region (Asia, Eastern Europe, or rest of world) and CDAI score (=\< 300 or \>300).||||||< 0.001
72414687|NCT01369342|144339700|SUPERIORITY_OR_OTHER||||||<|0.001||||||A fixed sequence testing procedure was used to control alpha at 0.05 over the outcome measures.|Cochran-Mantel-Haenszel chi-square test|2-sided Cochran-Mantel-Haenszel chi-square test, stratified by study region (Asia, Eastern Europe, or rest of world) and CDAI score (=\< 300 or \>300).||||||< 0.001
72414688|NCT01369342|144339701|SUPERIORITY_OR_OTHER|||||||0.009||||||A fixed sequence testing procedure was used to control alpha at 0.05 over the outcome measures.|Cochran-Mantel-Haenszel chi-square test|2-sided Cochran-Mantel-Haenszel chi-square test, stratified by study region (Asia, Eastern Europe, or rest of world) and CDAI score (=\< 300 or \>300).||||||0.009
72414689|NCT01369342|144339701|SUPERIORITY_OR_OTHER||||||<|0.001||||||A fixed sequence testing procedure was used to control alpha at 0.05 over the outcome measures.|Cochran-Mantel-Haenszel chi-square test|2-sided Cochran-Mantel-Haenszel chi-square test, stratified by study region (Asia, Eastern Europe, or rest of world) and CDAI score (=\< 300 or \>300).||||||< 0.001
72414690|NCT01369342|144339702|SUPERIORITY_OR_OTHER||||||<|0.001||||||A fixed sequence testing procedure was used to control alpha at 0.05 over the outcome measures.|Cochran-Mantel-Haenszel chi-square test|2-sided Cochran-Mantel-Haenszel chi-square test, stratified by study region (Asia, Eastern Europe, or rest of world) and CDAI score (=\< 300 or \>300).||||||< 0.001
72414691|NCT01369342|144339702|SUPERIORITY_OR_OTHER||||||<|0.001||||||A fixed sequence testing procedure was used to control alpha at 0.05 over the outcome measures.|Cochran-Mantel-Haenszel chi-square test|2-sided Cochran-Mantel-Haenszel chi-square test, stratified by study region (Asia, Eastern Europe, or rest of world) and CDAI score (=\< 300 or \>300).||||||< 0.001
72414692|NCT01369342|144339703|SUPERIORITY_OR_OTHER||||||<|0.001||||||A fixed sequence testing procedure was used to control alpha at 0.05 over the outcome measures.|Cochran-Mantel-Haenszel chi-square test|2-sided Cochran-Mantel-Haenszel chi-square test, stratified by study region (Asia, Eastern Europe, or rest of world) and CDAI score (=\< 300 or \>300).||||||< 0.001
72414693|NCT01369342|144339703|SUPERIORITY_OR_OTHER||||||<|0.001||||||A fixed sequence testing procedure was used to control alpha at 0.05 over the outcome measures.|Cochran-Mantel-Haenszel chi-square test|2-sided Cochran-Mantel-Haenszel chi-square test, stratified by study region (Asia, Eastern Europe, or rest of world) and CDAI score (=\< 300 or \>300).||||||< 0.001
72414694|NCT01369342|144339704|SUPERIORITY_OR_OTHER||||||<|0.001||||||A fixed sequence testing procedure was used to control alpha at 0.05 over the outcome measures.|Cochran-Mantel-Haenszel chi-square test|2-sided Cochran-Mantel-Haenszel chi-square test, stratified by study region (Asia, Eastern Europe, or rest of world) and CDAI score (=\< 300 or \>300).||||||< 0.001
72414695|NCT01369342|144339704|SUPERIORITY_OR_OTHER||||||<|0.001||||||A fixed sequence testing procedure was used to control alpha at 0.05 over the outcome measures.|Cochran-Mantel-Haenszel chi-square test|2-sided Cochran-Mantel-Haenszel chi-square test, stratified by study region (Asia, Eastern Europe, or rest of world) and CDAI score (=\< 300 or \>300).||||||< 0.001
72414696|NCT01816594|144339705|SUPERIORITY|||||||0.811|||||||Fisher Exact|(one-sided)||All participantss||||0.811
72414697|NCT01816594|144339706|SUPERIORITY|||||||0.83|||||||Fisher Exact|(one-sided)||wild type cohort||||0.830
72414698|NCT01816594|144339707|SUPERIORITY|||||||0.786|||||||Fisher Exact|(one-sided)||mutant cohort||||0.786
72414699|NCT01816594|144339708|SUPERIORITY|||||||0.286|||||||Fisher Exact|(one-sided)||All participants||||0.286
72414700|NCT01816594|144339709|SUPERIORITY|||||||0.177|||||||Fisher Exact|(one-sided)||wild type cohort||||0.177
72592957|NCT00614120|144717053|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is concluded if the two-sided upper limit of the 95% confidence interval for treatment difference in mean change in HbA1c between lira 1.2mg + met and glim + met is below 0.4%.|Estimated treatment difference, LS Mean|0.03|||<|0.0001||95.0|-0.14|0.2||In order to protect the overall Type I error rate when testing for non-inferiority of the three doses of lira + met to glim + met, the comparisons will be invoked sequentially for descending doses of liraglutide.|ANCOVA|ANCOVA model with treatment, country and previous treatment as fixed effects and baseline value as a covariate.|The p-values correspond to one-sided hypotheses of either superiority or non-inferiority. Statistical significance on a 2.5% level.|"Based on standard normal theory, the sample size needed in order to be able to show that lira + met is non-inferior to glim + met when using a 1:1 randomisation and a non-inferiority criteria of 0.4% with a power of at least 85%, is tabulated below using different SD of HbA1c.~Assuming a drop out rate of 25%, the total number of subjects to be randomised is 896 (224 for each dose of the liraglutide + metformin group and 224 subjects in metformin+glimepiride treatment group) with a SD of 1.2%."||0.20|-0.14|<.0001
72592958|NCT00614120|144717053|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is concluded if the two-sided upper limit of the 95% confidence interval for treatment difference in mean change in HbA1c between lira 0.6mg + met and glim + met is below 0.4%.|Estimated treatment difference, LS Mean|0.25||||0.0421||95.0|0.08|0.42||In order to protect the overall Type I error rate when testing for non-inferiority of the three doses of lira + met to glim + met, the comparisons will be invoked sequentially for descending doses of liraglutide.|ANCOVA|ANCOVA model with treatment, country and previous treatment as fixed effects and baseline value as a covariate.|The p-values correspond to one-sided hypotheses of either superiority or non-inferiority.|"Based on standard normal theory, the sample size needed in order to be able to show that lira + met is non-inferior to glim + met when using a 1:1 randomisation and a non-inferiority criteria of 0.4% with a power of at least 85%, is tabulated below using different SD of HbA1c.~Assuming a drop out rate of 25%, the total number of subjects to be randomised is 896 (224 for each dose of the liraglutide + metformin group and 224 subjects in metformin+glimepiride treatment group) with a SD of 1.2%."||0.42|0.08|0.0421
72414701|NCT01816594|144339710|SUPERIORITY|||||||0.929|||||||Fisher Exact|(one-sided)||mutant cohort||||0.929
72592959|NCT04789291|144717118|OTHER||Ratios of adjusted geometric means [%]|102.76|||||TWO_SIDED|90.0|99.34|106.29|||||Ratio calculated as test/reference\*100. Intra-individual Geometric coefficient of variation \[%\] = 4.8.|Relative bioavailability of BI 1595043 administered in fed state (Test) compared with BI 1595043 administered in fasted state (Reference) was estimated by the ratios of the gMeans (Test/Reference). Their corresponding 2-sided 90% CIs were provided. This method corresponds to 2 one-sided t-test procedures, each at the 5% significance level.||106.29|99.34|
72592960|NCT04789291|144717119|OTHER||Ratios of adjusted geometric means [%]|77.81|||||TWO_SIDED|90.0|69.77|86.76|||||Ratio calculated as test/reference\*100. Intra-individual Geometric coefficient of variation \[%\] = 15.5.|Relative bioavailability of BI 1595043 administered in fed state (Test) compared with BI 1595043 administered in fasted state (Reference) was estimated by the ratios of the gMeans (Test/Reference). Their corresponding 2-sided 90% CIs were provided. This method corresponds to 2 one-sided t-test procedures, each at the 5% significance level.||86.76|69.77|
72592961|NCT04789291|144717120|OTHER||Ratios of adjusted geometric means [%]|103.24|||||TWO_SIDED|90.0|99.73|106.89|||||Ratio calculated as test/reference\*100. Intra-individual Geometric coefficient of variation \[%\] = 4.9.|Relative bioavailability of BI 1595043 administered in fed state (Test) compared with BI 1595043 administered in fasted state (Reference) was estimated by the ratios of the gMeans (Test/Reference). Their corresponding 2-sided 90% CIs were provided. This method corresponds to 2 one-sided t-test procedures, each at the 5% significance level.||106.89|99.73|
72592962|NCT00805870|144717123|SUPERIORITY_OR_OTHER||Mean Difference (Net)|8.271|STANDARD_ERROR_OF_MEAN|26.298|>|0.05|TWO_SIDED|95.0|-63.521|46.978|||ANOVA|||Null hypothesis is that no difference is observed in quadriceps muscle strength between the fish oil and control groups.||46.978|-63.521|>0.05
72592963|NCT00805870|144717124|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.845|STANDARD_ERROR_OF_MEAN|1.417|>|0.05|TWO_SIDED|95.0|-4.823|1.132|||ANOVA|||Null hypothesis is that there is no difference in the amount of force applied to the quadriceps to elicit pain or discomfort between the fish oil and control groups.||1.132|-4.823|>0.05
72592964|NCT00805870|144717125|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-57.015|STANDARD_ERROR_OF_MEAN|47.093|>|0.05|TWO_SIDED|95.0|-156.373|42.344|||ANOVA|||Null hypothesis is that there is no difference in creatine kinase activity between the fish oil and the control groups.||42.344|-156.373|>0.05
72592965|NCT00805870|144717126|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.022|STANDARD_ERROR_OF_MEAN|0.188|>|0.05|TWO_SIDED|95.0|-0.374|0.417|||ANOVA|||The null hypothesis is that there is no difference in interleukin-6 concentration between the fish oil and control groups.||0.417|-0.374|>0.05
72414702|NCT01816594|144339711|SUPERIORITY|||||||0.811|||||||Fisher Exact|(one-sided)||||||0.811
72414703|NCT01816594|144339712|SUPERIORITY|||||||0.84|||||||Fisher Exact|(one-sided)||||||0.840
72414704|NCT01816594|144339713|SUPERIORITY|||||||0.724|||||||Fisher Exact|(one-sided)||||||0.724
72414705|NCT01816594|144339714|SUPERIORITY|||||||0.964|||||||Fisher Exact|(one-sided)||All participants||||0.964
72414706|NCT01816594|144339715|SUPERIORITY|||||||0.546|||||||Fisher Exact|(one-sided)||For ER+ participants - pCR||||0.546
72414707|NCT01816594|144339716|SUPERIORITY|||||||0.949|||||||Fisher Exact|(one-sided)||For ER- participants - pCR||||0.949
72414708|NCT01816594|144339717|SUPERIORITY|||||||0.053|||||||Fisher Exact|(one-sided)||For ER+ participants - ORR||||0.053
72414709|NCT01816594|144339718|SUPERIORITY|||||||0.949|||||||Fisher Exact|(one-sided)||For ER- participants - ORR||||0.949
72414710|NCT01816594|144339719|SUPERIORITY|||||||0.666|||||||Fisher Exact|(one-sided)||||||0.666
72414711|NCT01816594|144339720|SUPERIORITY|||||||0.803|||||||Fisher Exact|(one-sided)||||||0.803
72414712|NCT03905655|144339721|SUPERIORITY|||||||1|||||||t-test, 2 sided|||||||1.000
72414713|NCT03905655|144339721|SUPERIORITY|||||||1|||||||t-test, 2 sided|||||||1.000
72414714|NCT03905655|144339721|SUPERIORITY|||||||1|||||||t-test, 2 sided|||||||1.000
72414715|NCT03905655|144339722|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.000
72414716|NCT03905655|144339722|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.000
72414717|NCT03905655|144339722|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.000
72414718|NCT03905655|144339723|SUPERIORITY|||||||1|||||||t-test, 2 sided|||Comparison of Day 3 values||||1.000
72414719|NCT03905655|144339723|SUPERIORITY|||||||1|||||||t-test, 2 sided|||Comparison of Week 1 values||||1.000
72592966|NCT02484651|144717149|SUPERIORITY|||||||0.651|||||||t-test, 2 sided|||Sample size calculation was performed with a power of 0.80 and an α of 0.05, considering the primary hypothesis of a reduction in the BIS variability (measured as the standard deviation). A 25% reduction on the BIS variability (standard deviation) was considered clinically relevant, and gave a minimum sample size of 26 per group.||||0.651
72592967|NCT02484651|144717150|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||This statistical analysis applies to the propofol effect-site concentration. Sample size calculation was performed with a power of 0.80 and an α of 0.05 also a reduction in the propofol drug consumption (measured as the average effect-site concentration) during maintenance of anesthesia. A reduction on propofol mean effect-site concentration of 20% was considered clinically relevant, giving a minimum of 34 patients per group||||<0.001
72592968|NCT02484651|144717150|SUPERIORITY|||||||0.245|||||||t-test, 2 sided|||"This statistical analysis applies to the remifentanil effect-site concentration.~Sample size calculation was performed with a power of 0.80 and an α of 0.05 also a reduction in the remifentanil drug consumption (measured as the average effect-site concentration) during maintenance of anesthesia. A reduction on on remifentanil average effect-site concentration of 20% was considered clinically relevant, giving a minimum of 24 patients per group"||||0.245
72592969|NCT02484651|144717151|SUPERIORITY|||||||0.419|||||||Fisher Exact|||The null hypothesis was that PQRS overall recovery at 15 minutes was independent from the study group.||||0.419
72592970|NCT02484651|144717151|SUPERIORITY|||||||0.107|||||||Fisher Exact|||The null hypothesis was that PQRS overall recovery at 40 minutes was independent from the study group.||||0.107
72592971|NCT02484651|144717152|SUPERIORITY|||||||0.669|||||||Chi-squared|||The null hypothesis was that PQRS satisfaction with anesthetic care was independent of the study group.||||0.669
72592972|NCT04545567|144717156|SUPERIORITY|||||||0.004|||||||Wilcoxon (Mann-Whitney)|||||||0.004
72592973|NCT04545567|144717157|SUPERIORITY|||||||0.26|||||||Wilcoxon (Mann-Whitney)|||||||0.26
72592974|NCT04545567|144717158|SUPERIORITY|||||||0.2|||||||Wilcoxon (Mann-Whitney)|||||||0.2
72592975|NCT04545567|144717159|SUPERIORITY|||||||0.01|||||||Wilcoxon (Mann-Whitney)|||||||0.01
72592976|NCT04545567|144717160|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||||||1
72592977|NCT04545567|144717161|SUPERIORITY|||||||0.21|||||||t-test, 2 sided|||||||0.21
72592978|NCT04545567|144717162|SUPERIORITY||Mean Difference (Final Values)|0.73||||0.05|TWO_SIDED||||||t-test, 2 sided|||||||0.05
72592979|NCT04545567|144717163|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
72592980|NCT04545567|144717164|SUPERIORITY|||||||0.41|||||||Wilcoxon (Mann-Whitney)|||||||0.41
72592981|NCT04545567|144717165|SUPERIORITY|||||||0.54|||||||Wilcoxon (Mann-Whitney)|||||||0.54
72592982|NCT04545567|144717166|SUPERIORITY|||||||0.003|||||||Wilcoxon (Mann-Whitney)|||||||0.003
72592983|NCT04545567|144717167|SUPERIORITY|||||||0.52|||||||Wilcoxon (Mann-Whitney)|||||||0.52
72592984|NCT04545567|144717168|SUPERIORITY|||||||0.28|||||||t-test, 2 sided|||||||0.28
72592985|NCT04545567|144717169|SUPERIORITY||Mean Difference (Final Values)|0.38||||0.05|TWO_SIDED||||||t-test, 1 sided|||||||0.05
72592986|NCT04545567|144717170|SUPERIORITY|||||||0.007|||||||Wilcoxon (Mann-Whitney)|||||||0.007
72592987|NCT04545567|144717171|SUPERIORITY|||||||0.14|||||||Wilcoxon (Mann-Whitney)|||||||0.14
72592988|NCT04545567|144717172|OTHER|||||||0.22|||||||Wilcoxon (Mann-Whitney)|||||||0.22
72592989|NCT04545567|144717173|SUPERIORITY|||||||0.03|||||||Wilcoxon (Mann-Whitney)|||||||0.03
72592990|NCT04545567|144717174|SUPERIORITY|||||||0.49|||||||Wilcoxon (Mann-Whitney)|||||||0.49
72592991|NCT04545567|144717175|SUPERIORITY|||||||0.01|||||||t-test, 2 sided|||||||0.01
72592992|NCT03979807|144717176|OTHER||Adjusted Hazard Ratio|1.11|||||TWO_SIDED|95.0|1.06|1.17|||||Cox proportional hazard model. 'Treatment' is the only Independent variable used to estimate the hazard ratios. Umeclidinium/Vilanterol is Reference Group.|||1.17|1.06|
72592993|NCT02419612|144717191|SUPERIORITY||Least Squares (LS) Mean Difference|-0.37|STANDARD_ERROR_OF_MEAN|0.099|<|0.001|TWO_SIDED|95.0|-0.57|-0.18|||Mixed Models Analysis|Adjusted for for treatment, baseline HbA1c, visit, treatment-by-visit interaction, and baseline HbA1c-by-visit interaction.||||-0.18|-0.57|<0.001
72592994|NCT02419612|144717192|SUPERIORITY||LS Mean Difference|-4.06|STANDARD_ERROR_OF_MEAN|0.397|<|0.001|TWO_SIDED|95.0|-4.84|-3.28|||Mixed Models Analysis|Adjusted for for treatment, baseline body weight, visit, treatment-by-visit interaction, and baseline body weight-by-visit interaction.||||-3.28|-4.84|<0.001
72592995|NCT02419612|144717193|SUPERIORITY||Odds Ratio (OR)|1.5||||0.044||95.0|1.01|2.29|||Regression, Logistic|Adjusted for baseline HbA1c value||||2.29|1.01|0.044
72592996|NCT02419612|144717194|SUPERIORITY||LS Mean Difference|-3.6|STANDARD_ERROR_OF_MEAN|1.35||0.007|TWO_SIDED|95.0|-6.3|-1.0|||Mixed Models Analysis|Adjusted for treatment, baseline SBP, visit, treatment-by-visit interaction, and baseline SBP-by-visit interaction||||-1.0|-6.3|0.007
72592997|NCT02419612|144717195|SUPERIORITY||Hazard Ratio (HR)|0.15||||0.002|TWO_SIDED|95.0|0.04|0.5||This endpoint did not meet the required number of events (n=10) in each treatment arm, hence was excluded from sequential testing.|Regression, Cox Proportional Hazards|||Time to treatment intensification was analyzed using a Cox proportional hazards model.||0.50|0.04|0.002
72414720|NCT03905655|144339723|SUPERIORITY|||||||1|||||||t-test, 2 sided|||Comparison of Week 2 values||||1.000
72414721|NCT03905655|144339723|SUPERIORITY|||||||1|||||||t-test, 2 sided|||Comparison of Week 4 values||||1.000
72414722|NCT03905655|144339723|SUPERIORITY|||||||1|||||||t-test, 2 sided|||Comparison of Week 8 values||||1.000
72592998|NCT02419612|144717196|SUPERIORITY||Hazard Ratio (HR)|0.52|||<|0.001|TWO_SIDED|95.0|0.39|0.68|||Regression, Cox Proportional Hazards|||Time to treatment intensification was analyzed using a Cox proportional hazards model.||0.68|0.39|<0.001
72592999|NCT02419612|144717197|SUPERIORITY||Odds Ratio (OR)|2.1|STANDARD_ERROR_OF_MEAN|0.54||0.006|TWO_SIDED|95.0|1.23|3.42|||Regression, Logistic|Adjusted for baseline HbA1c value.||||3.42|1.23|0.006
72593000|NCT02419612|144717198|SUPERIORITY||Hazard Ratio (HR)|0.52|||<|0.001|TWO_SIDED|95.0|0.39|0.68|||Regression, Cox Proportional Hazards|||||0.68|0.39|<0.001
72593001|NCT00474045|144717203|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority can only be declared if the non-inferiority criterion was fulfilled for both (FAS and Per-protocol) analysis sets. Non-inferiority was declared if the upper limit of the two-sided 95% CI for the estimated treatment difference was below 0.4%.|Mean Difference (Final Values)|-0.06|STANDARD_ERROR_OF_MEAN|0.074||0.4||95.0|-0.21|0.08||P-value for superiority was calculated.|Regression, Linear|Treatment, country, pregnancy (preg.) status at randomisation (random.)-fixed. HbA1c at rand.(covariate) \& at rand. by preg. status (interaction)|Estimated treatment differences for IDet versus NPH at Visit P4 with the corresponding 95% confidence interval (CI) was calculated. Non-inferiority was established but superiority was not established.|Non-inferiority analysis with a null hypothesis stated that the difference between treatments, IDet-NPH, was equal to or larger than the pre-specified non-inferiority margin of 0.4%. In case non-inferiority was established it was also investigated if IDet was superior to NPH with a null hypothesis stating that the difference between IDet and NPH treatment groups is equal to or greater than 0.||0.08|-0.21|0.400
72593002|NCT00474045|144717204|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority can only be declared if the non-inferiority criterion was fulfilled for both (FAS and Per-protocol) analysis sets. Non-inferiority was declared if the upper limit of the two-sided 95% CI for the estimated treatment difference was below 0.4%.|Mean Difference (Final Values)|-0.15|STANDARD_ERROR_OF_MEAN|0.096||0.122||95.0|-0.34|0.04||P-value for superiority was calculated|Regression, Linear|Treatment, country, preg. status at rand.(fixed factors),HbA1c at rand.(covariate),HbA1c at rand. by preg. status (interaction)|Estimated treatment differences for IDet versus NPH at Visit P4 with the corresponding 95% CI was calculated. Non-inferiority was established but superiority was not established.|Non-inferiority analysis with a null hypothesis stated that the difference between treatments, IDet-NPH, was equal to or larger than the pre-specified non-inferiority margin of 0.4%. In case non-inferiority was established it was also investigated if IDet was superior to NPH with a null hypothesis stating that the difference between IDet and NPH treatment groups is equal to or greater than 0.||0.04|-0.34|0.122
72593003|NCT02278120|144717254|SUPERIORITY||Hazard Ratio, log|0.553|||<|1e-07|TWO_SIDED|95.0|0.441|0.694|||Log Rank|||||0.694|0.441|<0.0000001
72593004|NCT02278120|144717255|SUPERIORITY||Cox Proportional Hazard|0.712||||0.00973|TWO_SIDED|95.0|0.535|0.948||One-sided stratified log-rank test|Log Rank|||||0.948|0.535|0.00973
72593005|NCT02278120|144717256|SUPERIORITY|||||||0.00098|||||||Cochran-Mantel-Haenszel|||||||0.000980
72593006|NCT02278120|144717257|SUPERIORITY|||||||0.002|||||||Cochran-Mantel-Haenszel|||||||0.002
72593007|NCT01187498|144717267|NON_INFERIORITY_OR_EQUIVALENCE|A power analysis indicated that a sample size of 70 per group would provide 80% power with a one-sided alpha of 0.05 to declare two means equivalent, assuming a mean voiding frequency of 8.2 for behavioral treatment, a mean voiding frequency of 8.0 for drug therapy, and a standard deviation of 2.3 for both groups. Equivalence was defined as ±15% of the drug therapy posttreatment mean.|Difference of the Means|0.4|STANDARD_ERROR_OF_MEAN|0.346||0.001||95.0|||||Regression, Linear||The estimated parameter of dispersion is the standard error of the regression coefficient which measured the adjusted difference of the group means.|The primary analysis was an equivalence analysis to compare the two treatment groups on posttreatment 24- hour voiding frequency using a margin of ±15% of the drug group mean. Schuirmann's two one-sided tests (TOST) approach was used first to examine completers and then repeated using last observation carried forward to include participants who did not complete therapy. Adjusting the test to regression, the analyses were repeated using baseline voiding frequency as a covariate.||||.001
72593008|NCT01187498|144717268|SUPERIORITY_OR_OTHER||Difference of the Means|-0.38|STANDARD_ERROR_OF_MEAN|0.188||0.05||95.0|||||Regression, Linear||The estimated parameter of dispersion represents the standard error for the difference of the group means.|Standard regression methods adjusting for baseline values||||.05
72593009|NCT01187498|144717269|SUPERIORITY_OR_OTHER||Difference of Group Means|0.19|STANDARD_ERROR_OF_MEAN|0.091||0.05||95.0|||||t-test, 2 sided||The estimated parameter of dispersion represents the standard error for the difference of the group means.|Standard regression methods adjusting for baseline values||||.05
72593010|NCT01187498|144717270|SUPERIORITY_OR_OTHER||Difference in Group Means|-0.14|STANDARD_ERROR_OF_MEAN|0.091||0.33||95.0|||||t-test, 2 sided||The estimated parameter of dispersion represents the standard error for the difference of the group means.|Standard regression methods adjusting for baseline values||||.33
72593011|NCT01187498|144717271|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.2|STANDARD_ERROR_OF_MEAN|0.924||0.84||95.0|||||t-test, 2 sided||The estimated parameter of dispersion represents the standard error for the difference of the group means.|Standard regression methods adjusting for baseline values||||.84
72593012|NCT01187498|144717272|SUPERIORITY_OR_OTHER||Difference in Weighted Group Means|-0.0563|STANDARD_ERROR_OF_MEAN|0.1249||0.69||95.0|||||Cochran-Mantel-Haenszel||The estimated parameter of dispersion represents the standard error for the difference of the weighted group means.|Cochran Mantel-Haenszel procedure used to account for the ordinal nature of responses.||||.69
72593013|NCT01187498|144717273|SUPERIORITY_OR_OTHER||Difference between Group Weighted Means|-0.1563|STANDARD_ERROR_OF_MEAN|0.1009||0.16||95.0|||||Cochran-Mantel-Haenszel||The estimated parameter of dispersion represents the standard error for the difference of the weighted group means.|Cochran Mantel-Haenszel procedure used to account for the ordinal nature of responses.||||.16
72414723|NCT03905655|144339723|SUPERIORITY|||||||1|||||||t-test, 2 sided|||Comparison of Day 3 values||||1.000
72593014|NCT01187498|144717274|SUPERIORITY_OR_OTHER||Difference in Weighted Group Means|0.1079|STANDARD_ERROR_OF_MEAN|0.1625||0.56||95.0|||||Cochran-Mantel-Haenszel||The estimated parameter of dispersion represents the standard error for the difference of the weighted group means.|Cochran Mantel-Haenszel procedure used to account for the ordinal nature of responses.||||.56
72593015|NCT01187498|144717275|SUPERIORITY_OR_OTHER||Difference in Weighted Group Means|0.054|STANDARD_ERROR_OF_MEAN|0.1265||0.65||95.0|||||Cochran-Mantel-Haenszel||The estimated parameter of dispersion represents the standard error for the difference of the weighted group means.|Cochran Mantel-Haenszel procedure used to account for the ordinal nature of responses.||||.65
72593016|NCT01187498|144717276|SUPERIORITY_OR_OTHER|||||||0.01||95.0|||||Cochran-Mantel-Haenszel|||Cochran Mantel-Haenszel procedure used to account for the ordinal nature of responses.||||.01
72593017|NCT01187498|144717277|SUPERIORITY_OR_OTHER||Difference in Group Proportions|-0.21|STANDARD_ERROR_OF_MEAN|0.086||0.02||95.0|||||Chi-squared||The estimated parameter of dispersion represents the standard error for the difference of the group proportions.|Cochran Mantel-Haenszel procedure.||||.02
72593018|NCT00191282|144717282|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.98||||0.866||95.0|||||Log Rank|||To achieve 80% power, 490 pts need to experience primary combined CV outcome to detect diff. between treatments, assuming: \>=18.5% reduction in incidence of outcomes, 18 mo. pt recruitment, 18 mo. pt follow-up, 10% annual drop-out rate, 2-yr outcome incidence rate of \>=40% (pts in least efficacious treatment), and nominal 2-sided signif. of 0.045.||||0.866
72593019|NCT00191282|144717283|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.96||||0.715||95.0|||||Log Rank|||||||0.715
72593020|NCT00191282|144717284|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.01||||0.914||95.0|||||Log Rank|||||||0.914
72593021|NCT00191282|144717285|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.05||||0.706||95.0|||||Log Rank|||||||0.706
72593022|NCT00191282|144717286|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.0||||0.982||95.0|||||Log Rank|||||||0.982
72593023|NCT00191282|144717287|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.05||||0.816||95.0|||||Log Rank|||||||0.816
72593024|NCT00191282|144717288|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.01||||0.948||95.0|||||Log Rank|||||||0.948
72593025|NCT00191282|144717289|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.2||||0.581||95.0|||||Log Rank|||||||0.581
72593026|NCT00191282|144717290|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.09||||0.647||95.0|||||Log Rank|||||||0.647
72414724|NCT03905655|144339723|SUPERIORITY|||||||1|||||||t-test, 2 sided|||Comparison of Week 1 values||||1.000
72414725|NCT03905655|144339723|SUPERIORITY|||||||1|||||||t-test, 2 sided|||Comparison of Week 2 values||||1.000
72414726|NCT03905655|144339723|SUPERIORITY|||||||1|||||||t-test, 2 sided|||Comparison of Week 4 values||||1.000
72593027|NCT00191282|144717291|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.91||||0.525||95.0|||||Log Rank|||||||0.525
72593028|NCT00191282|144717292|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.13||||0.8||95.0|||||Log Rank|||||||0.800
72593029|NCT00191282|144717293|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.9||||0.662||95.0|||||Log Rank|||||||0.662
72593030|NCT00191282|144717294|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.93||||0.863||95.0|||||Log Rank|||||||0.863
72593031|NCT00191282|144717295|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.89||||0.471||95.0|||||Log Rank|||||||0.471
72593032|NCT00191282|144717296|SUPERIORITY_OR_OTHER|||||||0.7168||95.0|||||Chi-squared|||||||0.7168
72593033|NCT00191282|144717298|SUPERIORITY_OR_OTHER|||||||0.086||95.0|||||Chi-squared|||||||0.0860
72593034|NCT00191282|144717300|SUPERIORITY_OR_OTHER|||||||0.1424||95.0|||||Chi-squared|||||||0.1424
72593035|NCT00191282|144717303|SUPERIORITY_OR_OTHER|||||||0.1957||95.0|||||Chi-squared|||||||0.1957
72593036|NCT00191282|144717305|SUPERIORITY_OR_OTHER|||||||0.2434||95.0|||||Chi-squared|||||||0.2434
72593037|NCT00191282|144717307|SUPERIORITY_OR_OTHER|||||||0.2617||95.0|||||Chi-squared|||||||0.2617
72593038|NCT01726036|144717395|SUPERIORITY_OR_OTHER|||||||0.457|||||||Wilcoxon (Mann-Whitney)|||||||0.457
72593039|NCT01390428|144717396|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean Ratio (GMR)|1.21|||||TWO_SIDED|90.0|0.73|2.01|||||Mild Hepatic Impairment (HI)/Healthy Matched to Mild HI|Day 1||2.01|0.73|
72593040|NCT01390428|144717396|SUPERIORITY_OR_OTHER||GMR|1.66|||||TWO_SIDED|90.0|1.05|2.61|||||Mild HI/Healthy Matched to Mild HI|Day 10||2.61|1.05|
72593041|NCT01390428|144717396|SUPERIORITY_OR_OTHER||GMR|5.03|||||TWO_SIDED|90.0|2.19|11.56|||||Moderate HI/Healthy Matched to Moderate HI|Day 1||11.56|2.19|
72593042|NCT01390428|144717396|SUPERIORITY_OR_OTHER||GMR|4.82|||||TWO_SIDED|90.0|2.6|8.93|||||Moderate HI/Healthy Matched to Moderate HI|Day 10||8.93|2.60|
72593043|NCT01390428|144717396|SUPERIORITY_OR_OTHER||GMR|19.83|||||TWO_SIDED|90.0|8.11|48.51|||||Severe HI/Healthy Matched to Severe HI|Day 1||48.51|8.11|
72593044|NCT01390428|144717396|SUPERIORITY_OR_OTHER||GMR|11.68|||||TWO_SIDED|90.0|6.1|22.35|||||Severe HI/Healthy Matched to Severe HI|Day 10||22.35|6.10|
72593045|NCT01390428|144717397|SUPERIORITY_OR_OTHER||GMR|0.84|||||TWO_SIDED|90.0|0.35|2.01|||||Mild HI/Healthy Matched to Mild HI|Day 1||2.01|0.35|
72593046|NCT01390428|144717397|SUPERIORITY_OR_OTHER||GMR|1.37|||||TWO_SIDED|90.0|0.83|2.27|||||Mild HI/Healthy Matched to Mild HI|Day 10||2.27|0.83|
72593047|NCT01390428|144717397|SUPERIORITY_OR_OTHER||GMR|7.64|||||TWO_SIDED|90.0|2.74|21.27|||||Moderate HI/Healthy Matched to Moderate HI|Day 1||21.27|2.74|
72414727|NCT03905655|144339723|SUPERIORITY|||||||0.001|||||||t-test, 2 sided|||Comparison of Week 8 values||||0.001
72414728|NCT03905655|144339723|SUPERIORITY|||||||1|||||||t-test, 2 sided|||Comparison of Day 3 values||||1.000
72414729|NCT03905655|144339723|SUPERIORITY|||||||1|||||||t-test, 2 sided|||Comparison of Week 1 values||||1.000
72414730|NCT03905655|144339723|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||Comparison of Week 2 values||||<0.001
72414731|NCT03905655|144339723|SUPERIORITY|||||||0.002|||||||t-test, 2 sided|||Comparison of Week 4 values||||0.002
72414732|NCT03905655|144339723|SUPERIORITY|||||||1|||||||t-test, 2 sided|||Comparison of Week 8 values||||1.000
72414733|NCT03905655|144339724|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Day 3 values||||1.000
72414734|NCT03905655|144339724|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Week 1 values||||1.000
72414735|NCT03905655|144339724|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Week 2 values||||1.000
72593048|NCT01390428|144717397|SUPERIORITY_OR_OTHER||GMR|5.98|||||TWO_SIDED|90.0|2.84|12.57|||||Moderate HI/Healthy Matched to Moderate HI|Day 10||12.57|2.84|
72593049|NCT01390428|144717397|SUPERIORITY_OR_OTHER||GMR|15.18|||||TWO_SIDED|90.0|6.02|38.25|||||Severe HI/Healthy Matched to Severe HI|Day 1||38.25|6.02|
72593050|NCT01390428|144717397|SUPERIORITY_OR_OTHER||GMR|13.01|||||TWO_SIDED|90.0|6.0|28.21|||||Severe HI/Healthy Matched to Severe HI|Day 10||28.21|6.00|
72593051|NCT01390428|144717399|SUPERIORITY_OR_OTHER||GMR|1.86|||||TWO_SIDED|90.0|1.54|2.24|||||Mild HI/Healthy Matched to Mild HI|||2.24|1.54|
72593052|NCT01390428|144717399|SUPERIORITY_OR_OTHER||GMR|2.99|||||TWO_SIDED|90.0|1.31|6.82|||||Moderate HI/Healthy Matched to Moderate HI|||6.82|1.31|
72593053|NCT01390428|144717401|SUPERIORITY_OR_OTHER||GMR|1.92|||||TWO_SIDED|90.0|1.4|2.63|||||Mild HI/Healthy Matched to Mild HI|||2.63|1.40|
72593054|NCT01390428|144717401|SUPERIORITY_OR_OTHER||GMR|3.59|||||TWO_SIDED|90.0|1.81|7.11|||||Moderate HI/Healthy Matched to Moderate HI|||7.11|1.81|
72593055|NCT01390428|144717401|SUPERIORITY_OR_OTHER||GMR|9.34|||||TWO_SIDED|90.0|4.98|17.51|||||Severe HI/Healthy Matched to Severe HI|||17.51|4.98|
72593056|NCT04281784|144717403|SUPERIORITY||Risk Difference (RD)|0.0421||||0.027|TWO_SIDED|95.0|0.0047|0.0777||two-sided test, no adjustment for multiple comparisons|Regression, Linear|Occurrence of discussion regressed on randomization condition, adjusted for ADRD status, hospital, and time between study start \& randomization date.|Robust standard error|Usual care = reference group; intervention arm = comparison group||0.0777|0.0047|0.027
72593057|NCT04281784|144717405|SUPERIORITY||Mean Difference (Final Values)|-0.078|STANDARD_ERROR_OF_MEAN|0.246||0.75|TWO_SIDED|95.0|-0.56|0.404|||Regression, Linear|Outcome (days alive and out of ICU) regressed on Arm/Group (0=usual care, 1=intervention), adjusted for hospital and ADRD status|Robust (HC3) standard error|Superior outcome for Group 2||0.404|-0.560|0.750
72593058|NCT04281784|144717406|SUPERIORITY||Median Difference (Final Values)|-0.361|STANDARD_ERROR_OF_MEAN|0.357||0.312|TWO_SIDED|95.0|-1.06|0.338|||Regression, Linear|Outcome (days alive and out of hospital) regressed on Arm/Group (0=usual care, 1=intervention), adjusted for hospital and ADRD status|Robust (HC3) standard error|Superior outcome for Group 2||0.338|-1.060|0.312
72593059|NCT04281784|144717407|SUPERIORITY||Risk Difference (RD)|0.012||||0.475|TWO_SIDED|95.0|-0.02|0.043||two-sided test, no adjustment for multiple comparisons|Regression, Linear|Readmission (0, 1) regressed on randomization condition (0=usual care, 1=intervention), adjusted for ADRD status, and hospital site.|Robust standard error|Usual care = reference group; intervention arm = comparison group||0.043|-0.020|0.475
72593060|NCT04281784|144717408|SUPERIORITY||Risk Difference (RD)|-0.009||||0.61|TWO_SIDED|95.0|-0.043|0.025||two-sided test, no adjustment for multiple comparisons|Regression, Linear|ICU care (0,1) regressed on randomization condition (0=usual care, 1=intervention), adjusted for ADRD status, and hospital site.|Robust standard error|Usual care = reference group; intervention arm = comparison group||0.025|-0.043|0.610
72593061|NCT04281784|144717409|SUPERIORITY|Higher cost indicates worse outcome. Missing if cost data unavailable from Finance Office.|Slope|0.022|STANDARD_ERROR_OF_MEAN|0.058||0.71|TWO_SIDED|95.0|-0.092|0.135|||other type of regression|Generalized linear model (gamma family, log link); Outcome on study arm (0=control, 1=intervention) adjusted for hospital and ADRD status, robust SEs.|Robust standard error|Superior outcome for Group 2||0.135|-0.092|0.710
72593062|NCT04281784|144717410|SUPERIORITY||Risk Difference (RD)|0.487|STANDARD_ERROR_OF_MEAN|0.899||0.588|TWO_SIDED|95.0|-1.275|2.249||two-sided test, no adjustment for multiple comparisons|Regression, Linear|Died within 30 days after randomization regressed on randomization condition (0=usual care, 1=intervention) adjusted for hospital and ADRD status|Robust standard error|Usual care=reference group; intervention arm = comparison group||2.249|-1.275|0.588
72593063|NCT04281784|144717411|SUPERIORITY|Higher cost indicates worse outcome. Missing if cost data unavailable from Finance Office.|Slope|-0.028|STANDARD_ERROR_OF_MEAN|0.069||0.685|TWO_SIDED|95.0|-0.162|0.107|||other type of regression|Generalized linear model (gamma family, log link); Outcome on study arm (0=control, 1=intervention) adjusted for hospital and ADRD status, robust SEs.|Robust standard error|Superior outcome for Group 2||0.107|-0.162|0.685
72593064|NCT04322539|144717412|SUPERIORITY||Stratified Hazard Ratio|0.662|||<|0.001|TWO_SIDED|95.0|0.549|0.8||Raw unadjusted p-value was obtained by using a stratified log-rank test accounting for the randomization schedule stratification factors.|stratified log-rank test||The HR between 2 treatment groups (fruquintinib vs placebo), together with its 95 percent (%) confidence interval (CI), was calculated from a stratified Cox proportional hazards model accounting for the randomization schedule stratification factors.|||0.800|0.549|< .001
72593065|NCT04322539|144717413|SUPERIORITY||Hazard Ratio (HR)|0.321|||<|0.001|TWO_SIDED|95.0|0.267|0.386||Raw unadjusted p-value was obtained by using a stratified log-rank test accounting for the randomization schedule stratification factors.|stratified log-rank test||The HR between the 2 treatment groups (fruquintinib vs placebo), together with its 95% CI, was calculated from a stratified Cox proportional hazards model accounting for the randomization schedule stratification factors.|||0.386|0.267|< .001
72593066|NCT04322539|144717414|SUPERIORITY||Adjusted difference|1.5||||0.059|TWO_SIDED|95.0|0.4|2.7||p-value was calculated from a stratified Cochran-Mantel Haenszel test accounting for the randomization schedule stratification factors.|Cochran-Mantel-Haenszel||The adjusted difference and its 95% CI were calculated using the Wald method from Cochran-Mantel Haenszel test to account for the randomization schedule stratification factors.|||2.7|0.4|.059
72593067|NCT04322539|144717415|SUPERIORITY||Adjusted difference|39.4|||<|0.001|TWO_SIDED|95.0|32.8|46.0||p-value was calculated from a stratified Cochran-Mantel Haenszel test accounting for the randomization schedule stratification factors.|Cochran-Mantel-Haenszel||The adjusted difference and its 95% CI were calculated using the Wald method from Cochran-Mantel Haenszel test to account for the randomization schedule stratification factors.|||46.0|32.8|<.001
72593068|NCT04322539|144717421|OTHER|||||||0.06|||||||Wald test|||CminSS Based on the Starting Dose for OS Exposure-Response Analyses||||0.0600
72593069|NCT04322539|144717421|OTHER|||||||0.8065|||||||Wald test|||CminSS Based on the Adjusted RDI for OS Exposure-Response Analyses||||0.8065
72593070|NCT04322539|144717422|OTHER|||||||0.265|||||||Wald test|||CmaxSS for Gr Dermatological toxicity for Exposure-Response Analyses.||||0.265
72593071|NCT04322539|144717422|OTHER|||||||0.0159|||||||Wald test|||CmaxSS for Gr3+ Dermatological Toxicity for Exposure-Response Analyses.||||0.0159
72593072|NCT04322539|144717422|OTHER|||||||0.484|||||||Wald test|||CmaxSS for Gr Proteinuria for Exposure-Response Analyses.||||0.484
72414736|NCT03905655|144339724|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Week 4 values||||1.000
72414737|NCT03905655|144339724|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Week 8 values||||1.000
72414738|NCT03905655|144339724|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Week 12 values||||1.000
72414739|NCT03905655|144339724|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Day 3 values||||1.000
72414740|NCT03905655|144339724|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Week 1 values||||1.000
72593073|NCT04322539|144717422|OTHER|||||||0.642|||||||Wald test|||CmaxSS for Gr3+ Proteinuria for Exposure-Response Analyses.||||0.642
72593074|NCT04322539|144717422|OTHER|||||||0.166|||||||Wald test|||CmaxSS for Gr Hemorrhage for Exposure-Response Analyses.||||0.166
72593075|NCT01702532|144717428|SUPERIORITY_OR_OTHER||LS Means Difference|-4.9||||0.0141|TWO_SIDED|95.0|-8.8|-0.99||The comparison between treatments was conducted in a hierarchical order; consequently no adjustment of the significance level (5%) for multiplicity was needed.|ANCOVA|ANCOVA model contains pre-provocation baseline, pre-dosing post-provocation craving score, and the terms treatment groups and center as fixed|Comment: The confidence interval is for the difference between treatments groups|Null hypotheses considered change in craving score means from pre-dose post-provocation at 50 seconds to be equal for the two treatment groups.||-0.99|-8.80|0.0141
72593076|NCT01846221|144717430|OTHER|||||||0.38|||||||ANOVA|||||||0.38
72593077|NCT02634268|144717448|SUPERIORITY||Mean Difference (Final Values)|42.3||||0.02|TWO_SIDED|95.0|7.93|76.6|||Mixed Models Analysis|Difference in average six minute walk test distance at 12 months between control and intervention groups.|Standard errors estimated using Kenward-Rogers adjustment for the denominator degrees of freedom.|Linear mixed model analysis, including participants with a measurement at baseline and/or 12 months, comparing the average 12-month six minute walk test distance between control and intervention groups. Our analysis controlled for smoking and before/during the COVID-19 pandemic with fixed effects, while random effects were used for multiple measurement on individuals and study sites.||76.6|7.93|.02
72593078|NCT02634268|144717449|SUPERIORITY||Mean Difference (Final Values)|-0.36||||0.0008|TWO_SIDED|95.0|-0.63|-0.09|||Mixed Models Analysis|Difference in average Modified Borg Scale score at 12 months between control and intervention groups.|Standard errors estimated using Kenward-Rogers adjustment for the denominator degrees of freedom.|Linear mixed model analysis, including participants with a measurement at baseline and/or 12 months, comparing the average 12-month Modified Borg Scale score between control and intervention groups. Our analysis controlled for smoking and before/during the COVID-19 pandemic with fixed effects, while random effects were used for multiple measurement on individuals and study sites.||-0.09|-0.63|.0008
72593079|NCT02634268|144717450|SUPERIORITY||Mean Difference (Final Values)|-1.34||||0.0008|TWO_SIDED|95.0|-2.33|-0.34|||Mixed Models Analysis|Difference in average body weight at 12 months between control and intervention groups.|Standard errors estimated using Kenward-Rogers adjustment for the denominator degrees of freedom.|Linear mixed model analysis, including participants with a measurement at baseline and/or 12 months, comparing the average 12-month body weight between control and intervention groups. Our analysis controlled for smoking and before/during the COVID-19 pandemic with fixed effects, while random effects were used for multiple measurement on individuals and study sites.||-0.34|-2.33|0.0008
72593080|NCT02634268|144717451|SUPERIORITY||Mean Difference (Final Values)|1.48||||0.01|TWO_SIDED|95.0|0.35|2.6|||Mixed Models Analysis|Difference in average SF-12 PCS at 12 months between control and intervention groups.|Standard errors estimated using Kenward-Rogers adjustment for the denominator degrees of freedom.|Linear mixed model analysis, including participants with a measurement at baseline and/or 12 months, comparing the average 12-month SF-12 PCS between control and intervention groups. Our analysis controlled for smoking and before/during the COVID-19 pandemic with fixed effects, while random effects were used for multiple measurement on individuals and study sites.||2.60|0.35|0.01
72593081|NCT02634268|144717452|SUPERIORITY||Mean Difference (Final Values)|0.53||||0.45|TWO_SIDED|95.0|-0.84|1.89|||Mixed Models Analysis|Difference in average SF-12 MCS at 12 months between control and intervention groups.|Standard errors estimated using Kenward-Rogers adjustment for the denominator degrees of freedom.|Linear mixed model analysis, including participants with a measurement at baseline and/or 12 months, comparing the average 12-month SF-12 MCS between control and intervention groups. Our analysis controlled for smoking and before/during the COVID-19 pandemic with fixed effects, while random effects were used for multiple measurement on individuals and study sites.||1.89|-0.84|0.45
72593082|NCT02634268|144717453|SUPERIORITY||Mean Difference (Final Values)|-0.41||||0.009|TWO_SIDED|95.0|-0.71|-0.1|||Mixed Models Analysis|Difference in average Framingham Risk Score at 12 months between control and intervention groups.||Linear mixed model analysis, including participants with a measurement at baseline and/or 12 months, comparing the average 12-month Framingham Risk Score between control and intervention groups. Our analysis controlled for smoking and before/during the COVID-19 pandemic with fixed effects, while random effects were used for multiple measurement on individuals and study sites.||-0.10|-0.71|0.009
72593083|NCT02634268|144717454|SUPERIORITY||Mean Difference (Final Values)|-0.93||||0.13|TWO_SIDED|95.0|-2.12|0.26|||Mixed Models Analysis|Difference in average waist circumference at 12 months between control and intervention groups.|Standard errors estimated using Kenward-Rogers adjustment for the denominator degrees of freedom.|Linear mixed model analysis, including participants with a measurement at baseline and/or 12 months, comparing the average 12 month waist circumference between control and intervention groups. Our analysis controlled for smoking and before/during the COVID-19 pandemic with fixed effects, while random effects were used for multiple measurement on individuals and study sites.||0.26|-2.12|0.13
72414741|NCT03905655|144339724|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Week 2 values||||1.000
72414742|NCT03905655|144339724|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Week 4 values||||1.000
72593084|NCT02634268|144717455|SUPERIORITY||Mean Difference (Final Values)|-0.59||||0.64|TWO_SIDED|95.0|-3.02|1.84|||Mixed Models Analysis|Difference in average 12 month systolic blood at 12 months between control and intervention groups|Standard errors estimated using Kenward-Rogers adjustment for the denominator degrees of freedom.|Linear mixed model analysis, including participants with a measurement at baseline and/or 12 months, comparing the average 12-month systolic blood pressure between control and intervention groups. Our analysis controlled for smoking and before/during the COVID-19 pandemic with fixed effects, while random effects were used for multiple measurement on individuals and study sites.||1.84|-3.02|0.64
72593085|NCT02634268|144717456|SUPERIORITY||Mean Difference (Final Values)|-0.51||||0.004|TWO_SIDED|95.0|-0.85|-0.17|||Mixed Models Analysis|Difference in average BMI at 12 months between control and intervention groups.|Standard errors estimated using Kenward-Rogers adjustment for the denominator degrees of freedom.|Linear mixed model analysis, including participants with a measurement at baseline and/or 12 months, comparing the average 12-month BMI between control and intervention groups. Our analysis controlled for smoking and before/during the COVID-19 pandemic with fixed effects, while random effects were used for multiple measurement on individuals and study sites.||-0.17|-0.85|0.004
72414743|NCT03905655|144339724|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Week 8 values||||1.000
72593086|NCT02634268|144717457|SUPERIORITY||Mean Difference (Final Values)|-2.25||||0.09|TWO_SIDED|95.0|-4.87|0.36|||Mixed Models Analysis|Difference in average SGRQ-C Symptom score at 12 months between control and intervention groups.||Linear mixed model analysis, including participants with a measurement at baseline and/or 12 months, comparing the average 12 month SGRQ-C Symptom score between control and intervention groups. Our analysis controlled for smoking and before/during the COVID-19 pandemic with fixed effects, while random effects were used for multiple measurement on individuals and study sites.|Standard errors estimated using Kenward-Rogers adjustment for the denominator degrees of freedom.|0.36|-4.87|0.09
72593087|NCT02634268|144717458|SUPERIORITY||Mean Difference (Final Values)|-2.31||||0.12|TWO_SIDED|95.0|-5.19|0.56|||Mixed Models Analysis|Difference in average SGRQ-C Activity score at 12 months between control and intervention groups.|Standard errors estimated using Kenward-Rogers adjustment for the denominator degrees of freedom.|Linear mixed model analysis, including participants with a measurement at baseline and/or 12 months, comparing the average 12 month SGRQ-C Activity score between control and intervention groups. Our analysis controlled for smoking and before/during the COVID-19 pandemic with fixed effects, while random effects were used for multiple measurement on individuals and study sites.||0.56|-5.19|0.12
72593088|NCT02634268|144717459|SUPERIORITY||Mean Difference (Final Values)|-2.72||||0.03|TWO_SIDED|95.0|-5.19|-0.25|||Mixed Models Analysis|Difference in average SGRQ-C Impact score at 12 months between control and intervention groups.|Standard errors estimated using Kenward-Rogers adjustment for the denominator degrees of freedom.|Linear mixed model analysis, including participants with a measurement at baseline and/or 12 months, comparing the average 12 month SGRQ-C Impact score between control and intervention groups. Our analysis controlled for smoking and before/during the COVID-19 pandemic with fixed effects, while random effects were used for multiple measurement on individuals and study sites.||-0.25|-5.19|0.03
72593089|NCT02634268|144717460|SUPERIORITY||Mean Difference (Final Values)|-2.42||||0.03|TWO_SIDED|95.0|-4.55|-0.28|||Mixed Models Analysis|Difference in average SGRQ-C Total score at 12 months between control and intervention groups.|Standard errors estimated using Kenward-Rogers adjustment for the denominator degrees of freedom.|Linear mixed model analysis, including participants with a measurement at baseline and/or 12 months, comparing the average 12-month SGRQ-C Total score between control and intervention groups. Our analysis controlled for smoking and before/during the COVID-19 pandemic with fixed effects, while random effects were used for multiple measurement on individuals and study sites.||-0.28|-4.55|0.03
72414744|NCT03905655|144339724|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Week 12 values||||1.000
72593090|NCT02052596|144717472|NON_INFERIORITY|Criteria for non-inferiority: At one month after the last vaccine dose (Month 3 or Month 5), the upper limit (UL) of the 95% confidence interval (CI) for the anti-gE antibodies GMC ratio between the Control Group and the GSK1437173A Group had to be below (\<) 1.5,|Adjusted GMC ratio|1.11|||||TWO_SIDED|95.0|1.02|1.21||||Adjustment for baseline concentration and age - pooled variance.||Demonstration of non-inferiority of the humoral immune response to two doses of the GSK1437173A vaccine when Boostrix vaccine was co-administered with the first GSK1437173A vaccine dose compared to two doses of GSK1437173A vaccine (administered separately from Boostrix vaccine), one month after the last vaccine dose.||1.21|1.02|
72414745|NCT03905655|144339724|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Day 3 values||||1.000
72414746|NCT03905655|144339724|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Week 1 values||||1.000
72414747|NCT03905655|144339724|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Week 2 values||||1.000
72414748|NCT03905655|144339724|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Week 4 values||||1.000
72414749|NCT03905655|144339724|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Week 8 values||||1.000
72414750|NCT03905655|144339724|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Week 12 values||||1.000
72414751|NCT03905655|144339725|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Day 3 values||||1.000
72414752|NCT03905655|144339725|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Week 1 values||||1.000
72414753|NCT03905655|144339725|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Week 2 values||||1.000
72593091|NCT02052596|144717473|NON_INFERIORITY|Criteria for non-inferiority: At one month after the first vaccine dose (Month 1), the upper limit (UL) of the 95% confidence interval for the GMC ratio for anti-PT antibodies of the Control Group over the GSK1437173A Group had to be \< 1.5.|Adjusted GMC ratio|1.17|||||TWO_SIDED|95.0|1.0|1.36||||Ancova model: adjustment for baseline concentration - pooled variance.||Demonstration of non-inferiority of the humoral immune response to Boostrix vaccine when co-administered with GSK1437173A vaccine at first vaccination dose compared to Boostrix vaccine (administered separately from GSK1437173A) for pertussis toxoid (PT), one month after the vaccine dose.||1.36|1.00|
72593092|NCT02052596|144717473|NON_INFERIORITY|Criteria for non-inferiority: At one month after the first vaccine dose (Month 1), the upper limit (UL) of the 95% confidence interval for the GMC ratio for anti-FHA antibodies of the Control Group over the GSK1437173A Group had to be \< 1.5.|Adjusted GMC ratio|1.24|||||TWO_SIDED|95.0|1.07|1.44||||Adjustment for baseline concentration - pooled variance.||Demonstration of non-inferiority of the humoral immune response to Boostrix vaccine when co-administered with GSK1437173A vaccine at first vaccination dose compared to Boostrix vaccine (administered separately from GSK1437173A) for filamentous hemagglutinin (FHA) antigen, one month after the vaccine dose.||1.44|1.07|
72593093|NCT02052596|144717473|NON_INFERIORITY|Criteria for non-inferiority: At one month after the first vaccine dose (Month 1), the upper limit (UL) of the 95% confidence interval for the GMC ratio for anti-PRN antibodies of the Control Group over the GSK1437173A Group had to be \< 1.5.|Adjusted GMC ratio|1.27|||||TWO_SIDED|95.0|1.02|1.58||||Adjustment for baseline concentration - pooled variance.||Demonstration of non-inferiority of the humoral immune response to Boostrix vaccine when co-administered with GSK1437173A vaccine at first vaccination dose compared to Boostrix vaccine (administered separately from GSK1437173A) for pertactin (PRN) antigen, one month after the vaccine dose.||1.58|1.02|
72593094|NCT02052596|144717474|NON_INFERIORITY|Criteria for non-inferiority: At one month after the first vaccine dose (Month 1), the upper limit (UL) of the 95% confidence interval (CI) for the difference in the percentages of subjects with anti-diphtheria (anti-D) concentrations ≥ 1.0 IU/mL of the Control Group minus the GSK1437173A Group had to be \< 10%.|Difference in seropositivity rate|-0.1|||||TWO_SIDED|95.0|-3.03|2.85||||||Demonstration of non-inferiority of the humoral immune response to Boostrix vaccine when co-administered with GSK1437173A vaccine at first vaccination dose compared to Boostrix vaccine (administered separately from GSK1437173A) for diphteria (D) antigen, one month after the vaccine dose.||2.85|-3.03|
72593095|NCT02052596|144717474|NON_INFERIORITY|Criteria for non-inferiority: At one month after the first vaccine dose (Month 1), the upper limit (UL) of the 95% confidence interval (CI) for the difference in the percentages of subjects with anti-tetanus (anti-T) concentrations ≥ 1.0 IU/mL of the Control Group minus the GSK1437173A Group had to be \< 10%.|Difference in seropositivity rate|0.01|||||TWO_SIDED|95.0|-1.18|1.27||||||Demonstration of non-inferiority of the humoral immune response to Boostrix vaccine when co-administered with GSK1437173A vaccine at first vaccination dose compared to Boostrix vaccine (administered separately from GSK1437173A) for tetanus (T) antigen, one month after the vaccine dose.||1.27|-1.18|
72593096|NCT00640653|144717539|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.67||||0.03|TWO_SIDED|95.0|0.48|0.96||The significance criterion was set at alpha = .05.|generalized linear regression|Log link was specified|Treatment was coded as 1 vs health control coded as 0.|With alpha = .05, 2-tailed, and 37.4% of the control group initiating sexual intercourse by 24-month follow-up, a total sample size of 563 participants completing the trial was projected to provide power of 80% to detect a difference of 16.8% in self-reported sexual intercourse between an HIV intervention condition and the health promotion control condition.||0.96|0.48|.03
72593097|NCT02505334|144717545|SUPERIORITY|Superiority of liraglutide 1.8 mg/day vs. liraglutide 0.9 mg/day was to be considered confirmed if the 95% confidence interval for the treatment difference (liraglutide 1.8 mg/day minus liraglutide 0.9 mg/day) for change from baseline in HbA1c (% of HbA1c) was entirely below 0%, equivalent to a one-sided test with significance level of 2.5%.|Treatment difference|-0.4|||<|0.0001|TWO_SIDED|95.0|-0.55|-0.24|||ANCOVA|||Missing data was imputed using the LOCF method. The change from baseline in the response after 26 weeks of treatment was analysed using an ANCOVA model with treatment as a fixed effect and baseline response as a covariate.||-0.24|-0.55|<0.0001
72593098|NCT04442269|144717692|SUPERIORITY||Mean Difference|0.201||||0.0022|TWO_SIDED|95.0|0.0768|0.3256|||Mixed Models Analysis|||||0.3256|0.0768|0.0022
72593099|NCT04972968|144717710|SUPERIORITY||Cox Proportional Hazard|0.49||||0.012|TWO_SIDED|95.0|0.273|0.878||P-value \<= 0.05|Log Rank|Stratified by baseline randomization stratification factors \[Glucocorticoid use at Baseline (\>= 10 mg/day; \< 10 mg/day prednisone equivalent)\].||||0.878|0.273|0.012
72414754|NCT03905655|144339725|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Week 4 values||||1.000
72593100|NCT04972968|144717710|SUPERIORITY||Cox Proportional Hazard|0.443||||0.004|TWO_SIDED|95.0|0.248|0.794||P-value \<= 0.01|Log Rank|Stratified by baseline randomization stratification factors \[Glucocorticoid use at Baseline (\>= 10 mg/day; \< 10 mg/day prednisone equivalent)\]||||0.794|0.248|0.004
72593101|NCT04972968|144717710|SUPERIORITY||Cox Proportional Hazard|0.198|||<|0.001|TWO_SIDED|95.0|0.094|0.419||P-value \<= 0.001|Log Rank|Stratified by baseline randomization stratification factors \[Glucocorticoid use at Baseline (\>= 10 mg/day; \< 10 mg/day prednisone equivalent)\]||||0.419|0.094|<0.001
72593102|NCT04972968|144717711|SUPERIORITY||Mean Difference (Net)|18.7||||0.107|TWO_SIDED|95.0|-4.0|41.4|||Cochran-Mantel-Haenszel||From Cochran-Mantel-Haenszel test adjusting for baseline randomization stratification factors \[Glucocorticoid (GC) use at baseline (≥ 10 mg/day; \< 10 mg/day prednisone equivalent); Length of prior GC treatment for PMR (≤ 1 year; \> 1 year)\].|||41.4|-4.0|0.107
72593103|NCT04972968|144717711|SUPERIORITY||Mean Difference (Net)|18.9||||0.092|TWO_SIDED|95.0|-3.1|41.0||P-value ≤ 0.1|Cochran-Mantel-Haenszel||Cochran-Mantel-Haenszel test adjusting for baseline randomization stratification factors \[Glucocorticoid use at baseline (≥ 10 mg/day; \< 10 mg/day prednisone equivalent); Length of prior GC treatment for PMR (≤ 1 year; \> 1 year)\].|||41.0|-3.1|0.092
72414755|NCT03905655|144339725|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Week 8 values||||1.000
72414756|NCT03905655|144339725|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Week 12 values||||1.000
72414757|NCT03905655|144339725|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Day 3 values||||1.000
72414758|NCT03905655|144339725|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Week 1 values||||1.000
72414759|NCT03905655|144339725|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Week 2 values||||1.000
72414760|NCT03905655|144339725|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Week 4 values||||1.000
72593104|NCT04972968|144717711|SUPERIORITY||Mean Difference (Net)|41.9|||<|0.001|TWO_SIDED|95.0|21.4|62.3||P-value ≤ 0.001|Cochran-Mantel-Haenszel||Cochran-Mantel-Haenszel test adjusting for baseline randomization stratification factors \[Glucocorticoid use at baseline (≥ 10 mg/day; \< 10 mg/day prednisone equivalent); Length of prior GC treatment for PMR (≤ 1 year; \> 1 year)\].|||62.3|21.4|< 0.001
72593105|NCT04972968|144717712|SUPERIORITY||Mean Difference (Net)|-88.67||||0.144|TWO_SIDED|95.0|-208.04|30.71|||ANCOVA|P-value based on an Analysis of covariance (ANCOVA) model adjusting for baseline randomization stratification factors.|95% CI based on an Analysis of covariance (ANCOVA) model adjusting for baseline randomization stratification factors \[GC use at baseline (≥ 10 mg/day; \< 10 mg/day prednisone equivalent);|||30.71|-208.04|0.144
72593106|NCT04972968|144717712|SUPERIORITY||Mean Difference (Net)|-164.76||||0.007|TWO_SIDED|95.0|-283.62|-45.89||P-value ≤ 0.01|ANCOVA||P-value and 95% CI are based on an Analysis of covariance (ANCOVA) model adjusting for baseline randomization stratification factors \[Glucocorticoid use at baseline (≥ 10 mg/day; \< 10 mg/day prednisone\] equivalent);|||-45.89|-283.62|0.007
72414761|NCT03905655|144339725|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Week 8 values||||1.000
72414762|NCT03905655|144339725|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Week 12 values||||1.000
72414763|NCT03905655|144339725|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Day 3 values||||1.000
72414764|NCT03905655|144339725|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Week 1 values||||1.000
72414765|NCT03905655|144339725|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Week 2 values||||1.000
72414766|NCT03905655|144339725|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Week 4 values||||1.000
72593107|NCT04972968|144717712|SUPERIORITY||Mean Difference (Final Values)|-182.55||||0.003|TWO_SIDED|95.0|-300.52|-64.58||P-value ≤ 0.01|ANCOVA||P-value and 95% CI based on an Analysis of covariance (ANCOVA) model adjusting for baseline randomization stratification factors \[Glucocorticoid use at baseline (≥ 10 mg/day; \< 10 mg/day prednisone equivalent)|||-64.58|-300.52|0.003
72593108|NCT04972968|144717713|SUPERIORITY||Mean Difference (Net)|-1.58||||0.039|TWO_SIDED|95.0|-3.08|-0.08||P-value \<= 0.05|ANCOVA|P-value based on ANCOVA adjusting for baseline randomization stratification factors (GC use at baseline)||||-0.08|-3.08|0.039
72593109|NCT04972968|144717713|SUPERIORITY||Mean Difference (Final Values)|-2.66|||<|0.001|TWO_SIDED|95.0|-4.15|-1.16||P-value \<= 0.001|ANCOVA|P-value based on an ANCOVA model adjusting for baseline randomization stratification factors (GC use at baseline)|95% CI based on an ANCOVA model adjusting for baseline randomization stratification factors (GC use at baseline)|||-1.16|-4.15|<0.001
72593110|NCT04972968|144717713|SUPERIORITY||Mean Difference (Final Values)|-3.0|||<|0.001|TWO_SIDED|95.0|-4.49|-1.52||P-value \<= 0.001|ANCOVA|P-value based on an ANCOVA model adjusting for baseline randomization stratification factors (GC use at baseline)|95% CI based on an ANCOVA model adjusting for baseline randomization stratification factors (GC use at baseline)|||-1.52|-4.49|<0.001
72593111|NCT00514904|144717760|NON_INFERIORITY|Non-inferiority criterion: Lower limit \[LL\] of the 2-sided standardized asymptotic 95% confidence interval \[CI\] greater than or equal to (≥) -10%.|Difference in percentage|14.77|||||TWO_SIDED|95.0|10.26|20.23||||||||20.23|10.26|
72593112|NCT00514904|144717760|NON_INFERIORITY|Non-inferiority criterion: Lower limit \[LL\] of the 2-sided standardized asymptotic 95% confidence interval \[CI\] ≥-10%.|Difference in percentage|24.47|||||TWO_SIDED|95.0|17.52|31.87||||||||31.87|17.52|
72593113|NCT00514904|144717760|NON_INFERIORITY|Non-inferiority criterion: Lower limit \[LL\] of the 2-sided standardized asymptotic 95% confidence interval \[CI\] ≥-10%.|Difference in percentage|6.35|||||TWO_SIDED|95.0|2.68|11.08|||Difference in percentage|||||11.08|2.68|
72593114|NCT00514904|144717760|NON_INFERIORITY|Non-inferiority criterion: Lower limit \[LL\] of the 2-sided standardized asymptotic 95% confidence interval \[CI\] ≥-10%.|Difference in percentage|23.92|||||TWO_SIDED|95.0|18.02|30.3||||||||30.3|18.02|
72414767|NCT03905655|144339725|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Week 8 values||||1.000
72414768|NCT03905655|144339725|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Week 12 values||||1.000
72414769|NCT03905655|144339726|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Day 3 values||||1.000
72414770|NCT03905655|144339726|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Week 1 values||||1.000
72414771|NCT03905655|144339726|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Week 2 values||||1.000
72414772|NCT03905655|144339726|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Week 4 values||||1.000
72414773|NCT03905655|144339726|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Week 8 values||||1.000
72414774|NCT03905655|144339726|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Week 12 values||||1.000
72414775|NCT03905655|144339726|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Day 3 values||||1.000
72414776|NCT03905655|144339726|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Week 1 values||||1.000
72414777|NCT03905655|144339726|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Week 2 values||||1.000
72414778|NCT03905655|144339726|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Week 4 values||||1.000
72414779|NCT03905655|144339726|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Week 8 values||||1.000
72414780|NCT03905655|144339726|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Week 12 values||||1.000
72414781|NCT03905655|144339726|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Day 3 values||||1.000
72414782|NCT03905655|144339726|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Week 1 values||||1.000
72593115|NCT00514904|144717761|NON_INFERIORITY|Criterion for assessment: upper limit of the two-sided standardized asymptotic 95% confidence interval (CI) for the ratio between Nimenrix Group and Mencevax ACWY Group being lower than or equal to the pre-defined clinical limit ratio of 3.0 in the percentage of subjects with any grade 3 general symptoms.|Risk Ratio (RR)|3.34||||0.2202|TWO_SIDED|95.0|0.56|20.25|||Chi-squared|||||20.25|0.56|0.2202
72593116|NCT03408444|144717928|SUPERIORITY|Superiority is established if the adjusted upper confidence limit is below 0.|Mean Difference|-0.063|STANDARD_ERROR_OF_MEAN|0.0181|||TWO_SIDED|95.0|-0.106|-0.02|||Mixed Models Analysis|The Kenward and Roger method was used for the denominator degrees of freedom.|Mean difference was calculated as Test - Control|It was calculated that 160 participants randomized in a 1:1:1:1 fashion among the four arms would have at least 90% power to detect a 0.08 mm difference in mean axial elongation at the 6-month follow-up. The power analysis was conducted controlling 2-sided type I error of 0.05.||-0.020|-0.106|
72593117|NCT03408444|144717928|SUPERIORITY|Superiority is established if the adjusted upper confidence limit is below 0.|Mean Difference|-0.056|STANDARD_ERROR_OF_MEAN|0.0183|||TWO_SIDED|95.0|-0.1|-0.013|||Mixed Models Analysis|The Kenward and Roger method was used for the denominator degrees of freedom.|Mean difference was calculated as Test - Control|It was calculated that 160 participants randomized in a 1:1:1:1 fashion among the four arms would have at least 90% power to detect a 0.08 mm difference in mean axial elongation at the 6-month follow-up. The power analysis was conducted controlling 2-sided type I error of 0.05.||-0.013|-0.100|
72593118|NCT03408444|144717928|SUPERIORITY|Superiority is established if the adjusted upper confidence limit is below 0.|Mean Difference|-0.105|STANDARD_ERROR_OF_MEAN|0.0184|||TWO_SIDED|95.0|-0.149|-0.062|||Mixed Models Analysis|The Kenward and Roger method was used for the denominator degrees of freedom.|Mean difference was calculated as Test - Control|It was calculated that 160 participants randomized in a 1:1:1:1 fashion among the four arms would have at least 90% power to detect a 0.08 mm difference in mean axial elongation at the 6-month follow-up. The power analysis was conducted controlling 2-sided type I error of 0.05.||-0.062|-0.149|
72593119|NCT03408444|144717929|SUPERIORITY|Superiority is established if the adjusted lower confidence limit is above 0.|Mean Difference|0.08|STANDARD_ERROR_OF_MEAN|0.053|||TWO_SIDED|95.0|-0.04|0.21|||Mixed Models Analysis|Kenward and Roger method was for the denominator degrees of freedom.|Mean difference was calculated as Test - Control|It was calculated that 160 participants randomized in a 1:1:1:1 fashion among the four arms would have at least 79% power to detect a 0.20 D difference in mean axial elongation at the 6-month follow-up. The power analysis was conducted controlling 2-sided type I error of 0.05.||0.21|-0.04|
72593120|NCT03408444|144717929|SUPERIORITY|Superiority is established if the adjusted lower confidence limit is above 0.|Mean Difference|0.12|STANDARD_ERROR_OF_MEAN|0.054|||TWO_SIDED|95.0|-0.01|0.25|||Mixed Models Analysis|Kenward and Roger method was used for the denominator degrees of freedom|Mean difference was calculated as Test - Control|It was calculated that 160 participants randomized in a 1:1:1:1 fashion among the four arms would have at least 79% power to detect a 0.20 D difference in mean axial elongation at the 6-month follow-up. The power analysis was conducted controlling 2-sided type I error of 0.05.||0.25|-0.01|
72593121|NCT03408444|144717929|SUPERIORITY|Superiority is established if the adjusted lower confidence limit is above 0.|Mean Difference|0.22|STANDARD_ERROR_OF_MEAN|0.054|||TWO_SIDED|95.0|0.09|0.35|||Mixed Models Analysis|Kenward and Roger method was used for the denominator degrees of freedom.|Mean difference was calculated as Test - Control|It was calculated that 160 participants randomized in a 1:1:1:1 fashion among the four arms would have at least 79% power to detect a 0.20 D difference in mean axial elongation at the 6-month follow-up. The power analysis was conducted controlling 2-sided type I error of 0.05.||0.35|0.09|
72593122|NCT01473394|144717933|SUPERIORITY_OR_OTHER||Least square mean difference|-5.117|||<|1e-05|TWO_SIDED|95.0|-6.886|-3.347|||Mixed-effects model for repeated measure|||||-3.347|-6.886|<0.00001
72593123|NCT01473394|144717934|SUPERIORITY_OR_OTHER||Least square mean difference|-0.622|||<|1e-05|TWO_SIDED|95.0|-0.845|-0.399|||Mixed-effects model for repeated measure|||||-0.399|-0.845|<0.00001
72593124|NCT01473394|144717935|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.2||||0.0047|TWO_SIDED|95.0|3.0|17.4|||Cochran-Mantel-Haenszel||The Mean Difference (Final Values), as well as the 95% Confidence Interval, are in units of percentage.|||17.4|3.0|0.0047
72593125|NCT01482962|144717938|SUPERIORITY||Odds Ratio (OR)|0.6||||0.038|TWO_SIDED|95.0|0.33|1.08||P-value was stratified using disease type, International Prognostic Index (IPI) Score and region as stratification factors.|Cochran-Mantel-Haenszel|||||1.08|0.33|0.038
72593126|NCT01482962|144717939|SUPERIORITY||Hazard Ratio (HR)|0.87||||0.177|TWO_SIDED|95.0|0.637|1.178|||Stratified Log Rank||Hazard ratio (HR) was based on a stratified Cox's proportional hazard regression model with stratification factors: disease type, IPI Score and region with treatment as a factor in the model.|||1.178|0.637|0.177
72593127|NCT01482962|144717940|SUPERIORITY||Hazard Ratio (HR)|0.98||||0.338|TWO_SIDED|95.0|0.707|1.369|||Stratified Log-rank Test||Hazard ratio (HR) was based on a stratified Cox's proportional hazard regression model with stratification factors: disease type, IPI Score and region with treatment as a factor in the model.|||1.369|0.707|0.338
72593128|NCT01482962|144717945|SUPERIORITY||Hazard Ratio (HR)|0.95||||0.362|TWO_SIDED|95.0|0.679|1.329|||Stratified Log Rank||Hazard ratio was based on a stratified Cox's proportional hazard regression model with stratification factors: disease type, IPI Score and region with treatment as a factor in the model.|||1.329|0.679|0.362
72593129|NCT00001656|144718003|SUPERIORITY_OR_OTHER|||||||0.04||95.0|||||ANCOVA|Covariate is baseline score||Analysis of covariance with baseline score as covariate||||.04
72593130|NCT00001656|144718004|SUPERIORITY_OR_OTHER|||||||0.21||95.0|||||ANCOVA|Covariate is baseline score||Analysis of covariance with baseline score as covariate||||0.21
72593131|NCT00001656|144718005|SUPERIORITY_OR_OTHER|||||||0.35||95.0|||||ANCOVA|||Analysis of covariance with baseline score as covariate||||0.35
72414783|NCT03905655|144339726|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Week 2 values||||1.000
72593132|NCT00001656|144718006|SUPERIORITY_OR_OTHER|||||||0.19||95.0|||||ANCOVA|Covariate is baseline score||Analysis of covariance with baseline score as covariate||||0.19
72414784|NCT03905655|144339726|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Week 4 values||||1.000
72414785|NCT03905655|144339726|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Week 8 values||||1.000
72593133|NCT00001656|144718007|SUPERIORITY_OR_OTHER|||||||0.59||95.0|||||ANCOVA|Covariate is baseline score||Analysis of covariance with baseline score as covariate||||0.59
72593134|NCT00001656|144718008|SUPERIORITY_OR_OTHER|||||||0.72||95.0|||||ANCOVA|||Analysis of covariance with baseline score as covariate||||0.72
72593135|NCT00001656|144718009|SUPERIORITY_OR_OTHER|||||||0.27||95.0|||||ANCOVA|Covariate is baseline score||Analysis of covariance with baseline score as covariate||||0.27
72593136|NCT00001656|144718010|SUPERIORITY_OR_OTHER|||||||0.11||95.0|||||ANCOVA|Covariate is baseline score||||||0.11
72593137|NCT00001656|144718011|SUPERIORITY_OR_OTHER|||||||0.96||95.0|||||t-test, 2 sided|||||||0.96
72593138|NCT00001656|144718012|SUPERIORITY_OR_OTHER|||||||0.76||95.0|||||t-test, 2 sided|||||||0.76
72593139|NCT00001656|144718014|SUPERIORITY_OR_OTHER|||||||0.73||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.73
72593140|NCT02938949|144718039|SUPERIORITY||||||<|0.01|||||||ANOVA|||||||<0.01
72593141|NCT02938949|144718040|SUPERIORITY||||||>|0.2|||||||ANOVA|||||||> 0.20
72593142|NCT02938949|144718041|SUPERIORITY||||||>|0.2|||||||ANOVA|||||||>0.20
72593143|NCT01537068|144718080|SUPERIORITY_OR_OTHER||Test of Within-subjects effects|2.95||||0.09|TWO_SIDED||||||Mixed Models Analysis|Repeated Measures of ANOVA||||||0.09
72593144|NCT01537068|144718082|SUPERIORITY_OR_OTHER||Chi-squared|6.32||||0.025|TWO_SIDED||||||Chi-squared|||||||0.025
72593145|NCT00483704|144718083|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.54|||<|0.001|TWO_SIDED|95.0|1.8|3.58|||Regression, Logistic|Computed using a logistic regression model adjusting for geographic region, baseline migraine severity, and age.|An odds ratio \>1 is in favor of the first treatment group of the corresponding pairwise comparison.|||3.58|1.80|<0.001
72593146|NCT00483704|144718083|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.03|||<|0.001|TWO_SIDED|95.0|2.15|4.27|||Regression, Logistic|Computed using a logistic regression model adjusting for geographic region, baseline migraine severity, and age.|An odds ratio \>1 is in favor of the first treatment group of the corresponding pairwise comparison.|||4.27|2.15|<0.001
72593147|NCT00483704|144718084|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.03|||<|0.001|TWO_SIDED|95.0|2.35|3.9|||Regression, Logistic|Computed using a logistic regression model adjusting for geographic region, baseline migraine severity, and age.|An odds ratio \>1 is in favor of the first treatment group of the corresponding pairwise comparison.|||3.90|2.35|<0.001
72593148|NCT00483704|144718084|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.8|||<|0.001|TWO_SIDED|95.0|2.17|3.61|||Regression, Logistic|Computed using a logistic regression model adjusting for geographic region, baseline migraine severity, and age.|An odds ratio \>1 is in favor of the first treatment group of the corresponding pairwise comparison.|||3.61|2.17|<0.001
72593149|NCT00483704|144718085|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.85|||<|0.001|TWO_SIDED|95.0|2.05|7.23|||Regression, Logistic|Computed using a logistic regression model adjusting for geographic region, baseline migraine severity, and age.|An odds ratio \>1 is in favor of the first treatment group of the corresponding pairwise comparison.|||7.23|2.05|<0.001
72593150|NCT00483704|144718085|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.18|||<|0.001|TWO_SIDED|95.0|3.36|11.39|||Regression, Logistic|Computed using a logistic regression model adjusting for geographic region, baseline migraine severity, and age.|An odds ratio \>1 is in favor of the first treatment group of the corresponding pairwise comparison.|||11.39|3.36|<0.001
72593151|NCT00483704|144718086|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.62|||<|0.001|TWO_SIDED|95.0|1.96|3.51|||Regression, Logistic|Computed using a logistic regression model adjusting for geographic region, baseline migraine severity, and age.|An odds ratio \>1 is in favor of the first treatment group of the corresponding pairwise comparison.|||3.51|1.96|<0.001
72593152|NCT00483704|144718086|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.23|||<|0.001|TWO_SIDED|95.0|2.41|4.34|||Regression, Logistic|Computed using a logistic regression model adjusting for geographic region, baseline migraine severity, and age.|An odds ratio \>1 is in favor of the first treatment group of the corresponding pairwise comparison.|||4.34|2.41|<0.001
72593153|NCT00483704|144718087|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.65|||<|0.001|TWO_SIDED|95.0|1.3|2.11|||Regression, Logistic|Computed using a logistic regression model adjusting for geographic region, baseline migraine severity, and age.|An odds ratio \>1 is in favor of the first treatment group of the corresponding pairwise comparison.|||2.11|1.30|<0.001
72593154|NCT00483704|144718087|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.67|||<|0.001|TWO_SIDED|95.0|1.31|2.14|||Regression, Logistic|Computed using a logistic regression model adjusting for geographic region, baseline migraine severity, and age.|An odds ratio \>1 is in favor of the first treatment group of the corresponding pairwise comparison.|||2.14|1.31|<0.001
72593155|NCT00483704|144718088|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.74|||<|0.001|TWO_SIDED|95.0|1.36|2.22|||Regression, Logistic|Computed using a logistic regression model adjusting for geographic region, baseline migraine severity, and age.|An odds ratio \>1 is in favor of the first treatment group of the corresponding pairwise comparison.|||2.22|1.36|<0.001
72593156|NCT00483704|144718088|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.61|||<|0.001|TWO_SIDED|95.0|1.26|2.06|||Regression, Logistic|Computed using a logistic regression model adjusting for geographic region, baseline migraine severity, and age.|An odds ratio \>1 is in favor of the first treatment group of the corresponding pairwise comparison.|||2.06|1.26|<0.001
72593157|NCT00483704|144718089|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.67|||<|0.001|TWO_SIDED|95.0|1.28|2.17|||Regression, Logistic|Computed using a logistic regression model adjusting for geographic region, baseline migraine severity, and age.|An odds ratio \>1 is in favor of the first treatment group of the corresponding pairwise comparison.|||2.17|1.28|<0.001
72414786|NCT03905655|144339726|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Week 12 values||||1.000
72593158|NCT00483704|144718089|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.57|||<|0.001|TWO_SIDED|95.0|1.21|2.04|||Regression, Logistic|Computed using a logistic regression model adjusting for geographic region, baseline migraine severity, and age.|An odds ratio \>1 is in favor of the first treatment group of the corresponding pairwise comparison.|||2.04|1.21|<0.001
72593159|NCT00483704|144718092|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.69|||<|0.001|TWO_SIDED|95.0|1.78|4.07|||Regression, Logistic|Computed using a logistic regression model adjusting for geographic region, baseline migraine severity, and age.|An odds ratio \>1 is in favor of the first treatment group of the corresponding pairwise comparison.|||4.07|1.78|<0.001
72593160|NCT00483704|144718092|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.45|||<|0.001|TWO_SIDED|95.0|2.3|5.19|||Regression, Logistic|Computed using a logistic regression model adjusting for geographic region, baseline migraine severity, and age.|An odds ratio \>1 is in favor of the first treatment group of the corresponding pairwise comparison.|||5.19|2.30|<0.001
72593161|NCT00483704|144718093|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.4|||<|0.001|TWO_SIDED|95.0|1.56|3.69|||Regression, Logistic|Computed using a logistic regression model adjusting for geographic region, baseline migraine severity, and age.|An odds ratio \>1 is in favor of the first treatment group of the corresponding pairwise comparison.|||3.69|1.56|<0.001
72593162|NCT00483704|144718093|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.37|||<|0.001|TWO_SIDED|95.0|2.22|5.12|||Regression, Logistic|Computed using a logistic regression model adjusting for geographic region, baseline migraine severity, and age.|An odds ratio \>1 is in favor of the first treatment group of the corresponding pairwise comparison.|||5.12|2.22|<0.001
72593163|NCT00483704|144718094|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.36|||<|0.001|TWO_SIDED|95.0|1.65|3.38|||Regression, Logistic|Computed using a logistic regression model adjusting for geographic region, baseline migraine severity, and age.|An odds ratio \>1 is in favor of the first treatment group of the corresponding pairwise comparison.|||3.38|1.65|<0.001
72593164|NCT00483704|144718094|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.81|||<|0.001|TWO_SIDED|95.0|1.97|4.01|||Regression, Logistic|Computed using a logistic regression model adjusting for geographic region, baseline migraine severity, and age.|An odds ratio \>1 is in favor of the first treatment group of the corresponding pairwise comparison.|||4.01|1.97|<0.001
72414787|NCT03905655|144339727|SUPERIORITY|||||||0.006|||||||t-test, 2 sided|||Comparison of Week 1 values||||0.006
72414788|NCT03905655|144339727|SUPERIORITY|||||||0.003|||||||t-test, 2 sided|||Comparison of Week 2 values||||0.003
72414789|NCT03905655|144339727|SUPERIORITY|||||||0.004|||||||t-test, 2 sided|||Comparison of Week 4 values||||0.004
72414790|NCT03905655|144339727|SUPERIORITY|||||||0.006|||||||t-test, 2 sided|||Comparison of Week 8 values||||0.006
72593165|NCT00483704|144718095|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.32|||<|0.001|TWO_SIDED|95.0|1.52|3.54|||Regression, Logistic|Computed using a logistic regression model adjusting for geographic region, baseline migraine severity, and age.|An odds ratio \>1 is in favor of the first treatment group of the corresponding pairwise comparison.|||3.54|1.52|<0.001
72414791|NCT03905655|144339727|SUPERIORITY|||||||0.002|||||||t-test, 2 sided|||Comparison of Week 12 values||||0.002
72593166|NCT00483704|144718095|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.02|||<|0.001|TWO_SIDED|95.0|2.0|4.56|||Regression, Logistic|Computed using a logistic regression model adjusting for geographic region, baseline migraine severity, and age.|An odds ratio \>1 is in favor of the first treatment group of the corresponding pairwise comparison.|||4.56|2.00|<0.001
72593167|NCT00819780|144718096|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|0.871||||0.3531|TWO_SIDED|95.0|0.651|1.166|||Stratified Cox proportional hazards|The Cox proportional hazard model is stratified by prior adjuvant oxaliplatin therapy|A hazard ratio \< 1.0 favors panitumumab|||1.166|0.651|0.3531
72593168|NCT00819780|144718097|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|0.723||||0.1386|TWO_SIDED|95.0|0.47|1.111|||Stratified Cox proportional hazards|The Cox proportional hazard model is stratified by prior adjuvant oxaliplatin therapy|A hazard ratio \< 1.0 favors panitumumab|||1.111|0.470|0.1386
72593169|NCT00819780|144718098|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.19||||0.5497|TWO_SIDED|95.0|0.72|1.95|||Stratified exact test|Stratified by prior adjuvant oxaliplatin therapy|The odds ratio is defined as the odds of having an objective response in the panitumumab plus mFOLFOX6 arm relative to the odds in the bevacizumab plus mFOLFOX6 arm.|||1.95|0.72|0.5497
72593170|NCT00819780|144718100|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|0.874||||0.3861|TWO_SIDED|95.0|0.645|1.185|||Stratified Cox proportional hazards|The Cox proportional hazard model is stratified by prior adjuvant oxaliplatin therapy|A hazard ratio \< 1.0 favors panitumumab|||1.185|0.645|0.3861
72593171|NCT00819780|144718103|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|0.651||||0.0286|TWO_SIDED|95.0|0.444|0.956|||Stratified Cox proportional hazards|The Cox proportional hazard model is stratified by prior adjuvant oxaliplatin therapy|A hazard ratio \< 1.0 favors panitumumab|||0.956|0.444|0.0286
72593172|NCT00819780|144718104|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|0.579||||0.0083|TWO_SIDED|95.0|0.386|0.869|||Stratified Cox proportional hazards|The Cox proportional hazard model is stratified by prior adjuvant oxaliplatin therapy|A hazard ratio \< 1.0 favors panitumumab|||0.869|0.386|0.0083
72593173|NCT00819780|144718105|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|0.606||||0.0934|TWO_SIDED|95.0|0.337|1.088|||Stratified Cox proportional hazards|The Cox proportional hazard model is stratified by prior adjuvant Oxaliplatin therapy|A hazard ratio \< 1.0 favors panitumumab|||1.088|0.337|0.0934
72593174|NCT00819780|144718106|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|0.465||||0.0235|TWO_SIDED|95.0|0.239|0.902|||Stratified Cox proportional hazards|The Cox proportional hazard model is stratified by prior adjuvant oxaliplatin therapy|A hazard ratio \< 1.0 favors panitumumab|||0.902|0.239|0.0235
72593175|NCT00819780|144718107|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.08||||0.9426|TWO_SIDED|95.0|0.55|2.12|||Stratified exact test|Stratified by prior exposure to oxaliplatin|The odds ratio is defined as the odds of having an objective response in the panitumumab plus mFOLFOX6 arm relative to the odds in the bevacizumab plus mFOLFOX6 arm.|||2.12|0.55|0.9426
72593176|NCT00819780|144718108|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.05||||1|TWO_SIDED|95.0|0.52|2.15|||Stratified exact test|Stratified by prior exposure to oxaliplatin|The odds ratio is defined as the odds of having an objective response in the panitumumab plus mFOLFOX6 arm relative to the odds in the bevacizumab plus mFOLFOX6 arm.|||2.15|0.52|1.0000
72593177|NCT04450407|144718118|NON_INFERIORITY|The non-inferiority margin is 0.4%. Non-inferiority is achieved if the upper limit of the 90% CI (Confidence Interval) is below 0.4.|LS Mean Difference|0.17|||||TWO_SIDED|90.0|0.01|0.32||||||||0.32|0.01|
72593178|NCT02832375|144718130|SUPERIORITY_OR_OTHER||Least Square (LS) mean difference|-0.45|||<|0.0001|TWO_SIDED|95.0|-0.577|-0.319|||ANCOVA|From ANCOVA model with change from baseline in Schiff Sensitivity Score as response and treatment and baseline Schiff sensitivity score as covariates.|Difference is first named dentifrice minus second named dentifrice such that a negative difference favours first named dentifrice.|H0= no difference between experimental dentifrice and control dentifrice H1= a difference between experimental dentifrice and control dentifrice||-0.319|-0.577|<0.0001
72593179|NCT06350461|144718133|NON_INFERIORITY|The non-inferiority margin is -3.|Median Difference (Final Values)|-0.324|||<|0.0001|TWO_SIDED|95.0|-1.3|0.6||One-sided test for non-inferiority|ANOVA|Adjusted for four dichotomous randomization strata.|Direction of difference is Discontinue - Continue.|The non-inferiority test was a priori designed to be conducted on the per-protocol (PP) population.||0.6|-1.3|<0.0001
72593180|NCT06350461|144718134|SUPERIORITY||Mean Difference (Final Values)|0.06||||0.733|TWO_SIDED|95.0|-0.4|0.4|||ANOVA|Adjusted for four dichotomous randomization strata.|Direction of difference is Discontinue - Continue|||0.4|-0.4|0.733
72593181|NCT06350461|144718135|SUPERIORITY||Mean Difference (Final Values)|-1.52||||0.226|TWO_SIDED|95.0|-4.1|0.9|||ANOVA|Adjusted for four dichotomous randomization strata.|Direction of difference is Discontinue - Continue.|||0.9|-4.1|0.226
72593182|NCT06350461|144718136|SUPERIORITY||Mean Difference (Final Values)|0.18||||0.857|TWO_SIDED|95.0|-1.8|2.1|||ANOVA|Adjusted for four dichotomous randomization strata|Direction of the difference is Discontinue - Continue|||2.1|-1.8|0.857
72593183|NCT06350461|144718137|SUPERIORITY||Mean Difference (Final Values)|0.64||||0.16|TWO_SIDED|95.0|-0.25|1.54|||t-test, 2 sided||Direction of the difference is Discontinue - Continue|||1.54|-0.25|0.16
72593184|NCT06350461|144718138|SUPERIORITY||Mean Difference (Final Values)|-0.24||||0.56|TWO_SIDED|95.0|-1.04|0.57|||t-test, 2 sided||Direction of the difference is Discontinue - Continue|||0.57|-1.04|0.56
72593185|NCT06350461|144718139|SUPERIORITY||Difference in % Participants|1.1||||0.653|TWO_SIDED|95.0|-3.7|6.1|||Fisher Exact||Confidence interval calculated using the Newcombe-Wilson method without continuity correction. Direction of difference is Discontinue - Continue.|Null hypothesis: proportion of participants initiating acute antibiotics is the same in the Discontinue and Continue arms||6.1|-3.7|0.653
72593186|NCT06350461|144718140|SUPERIORITY||Difference in % Participants|0.5||||0.622|TWO_SIDED|95.0|-2.0|3.4|||Fisher Exact||Confidence interval calculated using the Newcombe-Wilson method without continuity correction. Direction of difference is Discontinue - Continue.|Null hypothesis: proportion of participants with at least one hospitalization is the same in Discontinue and Continue arms.||3.4|-2.0|0.622
72414792|NCT03905655|144339727|SUPERIORITY|||||||0.141|||||||t-test, 2 sided|||Comparison of Week 1 values||||0.141
72414793|NCT03905655|144339727|SUPERIORITY|||||||0.081|||||||t-test, 2 sided|||Comparison of Week 2 values||||0.081
72414794|NCT03905655|144339727|SUPERIORITY|||||||0.16|||||||t-test, 2 sided|||Comparison of Week 4 values||||0.160
72414795|NCT03905655|144339727|SUPERIORITY|||||||0.184|||||||t-test, 2 sided|||Comparison of Week 8 values||||0.184
72414796|NCT03905655|144339727|SUPERIORITY|||||||0.046|||||||t-test, 2 sided|||Comparison of Week 12 values||||0.046
72414797|NCT03905655|144339727|SUPERIORITY|||||||0.379|||||||t-test, 2 sided|||Comparison of Week 1 values||||0.379
72593187|NCT06350461|144718141|SUPERIORITY||Difference in % Participants|-1.1||||0.623|TWO_SIDED|95.0|-4.1|1.6|||Fisher Exact||Confidence interval calculated using the Newcombe-Wilson method without continuity correction. Direction of difference is Discontinue - Continue.|Null hypothesis: proportion of participants with at least one protocol-defined pulmonary exacerbation is the same in Discontinue and Continue arms.||1.6|-4.1|0.623
72593188|NCT06350461|144718142|SUPERIORITY||Difference in % Participants|11.7||||0.0165|TWO_SIDED|95.0|2.4|20.7|||Fisher Exact||Confidence interval calculated using the Newcombe-Wilson method without continuity correction. Direction of difference is Discontinue - Continue.|Null hypothesis: proportion of participants with at least one AE is the same in Discontinue and Continue arms.||20.7|2.4|0.0165
72593189|NCT06350461|144718143|SUPERIORITY||Rate Ratio|1.29||||0.0958|TWO_SIDED|95.0|0.96|1.74|||Poisson Regression|||Rate ratio, confidence interval, and p-value calculated using Poisson Regression with an offset for the log of follow-up time in weeks. The total number of follow-up weeks in the HS-discontinue and HS-continue arms are 1135.7 and 1163.9 weeks, respectively. Ratio is Discontinue / Continue.||1.74|0.96|0.0958
72593190|NCT06350461|144718144|SUPERIORITY||Difference in % Participants|2.17||||0.1215|TWO_SIDED|95.0|-0.7|5.7|||Fisher Exact||Confidence interval calculated using the Newcombe-Wilson method without continuity correction. Direction of difference is Discontinue - Continue.|Null hypothesis: proportion of participants changing assigned regimen is the same in Discontinue and Continue arms.||5.7|-0.7|0.1215
72593191|NCT00084318|144718145|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.76||||0.05|TWO_SIDED|95.0|0.54|1.06|||Log Rank|Historical control data (RTOG-9501/NCT00002670): n=202, two-year disease-free survival rate of 54.8% (47.9% to 61.7%).||Using the method of Dixon and Simon, 104 analyzable patients per arm were needed to detect a ≥ 33 reduction in the hazard rate for disease-free survival compared to historical control data (the chemoradiation arm of study RTOG-9501/NCT00002670) with 80% power and one-sided log-rank test at the 0.05 level. Two-year rates were estimated by the Kaplan-Meier method. \[RTOG = Radiation Therapy Oncology Group\]||1.06|0.54|0.05
72593192|NCT00084318|144718145|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.69||||0.01|TWO_SIDED|95.0|0.5|0.96|||Log Rank|Historical control data (RTOG-9501/NCT00002670): n=202, two-year disease-free survival rate of 54.8% (47.9% to 61.7%).||Using the method of Dixon and Simon, 104 analyzable patients per arm were needed to detect a ≥ 33 reduction in the hazard rate for disease-free survival compared to historical control data (the chemoradiation arm of study RTOG-9501/NCT00002670) with 80% power and one-sided log-rank test at the 0.05 level. Two-year rates were estimated by the Kaplan-Meier method.||0.96|0.50|0.01
72593193|NCT00084318|144718146|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.72||||0.04|TWO_SIDED|95.0|0.5|1.03|||Log Rank|Historical control data (RTOG-9501/NCT00002670): n=202, two-year survival rate of 64.7% (58.1% to 71.3%).|Reference arm = historical control|Two-year rates were estimated by the Kaplan-Meier method. RTOG 0234 results were compared to historical control data (the chemoradiation arm of study RTOG-9501/NCT00002670) by 1-sided log-rank test. Hazard ratios were estimated by Cox model. \[RTOG = Radiation Therapy Oncology Group\]||1.03|0.5|0.04
72593194|NCT00084318|144718146|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.56||||0.001|TWO_SIDED|95.0|0.39|0.82|||Log Rank|Historical control data (RTOG-9501/NCT00002670): n=202, two-year survival rate of 64.7% (58.1% to 71.3%).|Reference arm = historical control|Two-year rates were estimated by the Kaplan-Meier method. RTOG 0234 results were compared to historical control data (the chemoradiation arm of study RTOG-9501/NCT00002670) by 1-sided log-rank test. Hazard ratios were estimated by Cox model.||0.82|0.39|0.001
72593195|NCT00084318|144718150|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.05||||0.66|TWO_SIDED|95.0|0.63|1.76|||Gray's test|Historical control data (RTOG-9501/NCT00002670): n=202, two-year failure rate of 19.9% (12.2% to 27.5%)|Reference arm = historical control|Two-year failure rates were estimated by the cumulative incidence method. RTOG 0234 results were compared to historical control data (the chemoradiation arm of study RTOG-9501/NCT00002670) by 1-sided Gray's test. Hazard ratios were estimated by Cox model. \[RTOG = Radiation Therapy Oncology Group\]||1.76|0.63|0.66
72593196|NCT00084318|144718150|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.16||||0.86|TWO_SIDED|95.0|0.72|1.87|||Gray's test|Historical control data (RTOG-9501/NCT00002670): n=202, two-year failure rate of 19.9% (12.2% to 27.5%)|Reference arm = historical control|Two-year failure rates were estimated by the cumulative incidence method. RTOG 0234 results were compared to historical control data (the chemoradiation arm of study RTOG-9501/NCT00002670) by 1-sided Gray's test. Hazard ratios were estimated by Cox model.||1.87|0.72|0.86
72593197|NCT03301740|144718165|EQUIVALENCE|The equivalence margin is the standard error of the estimated differences between UF and standard treatment from the repeated measure mixed model.|Odds Ratio (OR)|1.2||||0.5|TWO_SIDED|95.0|0.8|1.7||Statistically significant p-value is \<0.05|Mixed Models Analysis|||Null hypothesis = no difference in intradialytic hypotension between UF profiling and conventional HD. Likelihood ratio tests were performed using repeated measure logistic regression with the binary treatment indicator as a fixed effect predictor and assigning each subject a random intercept term. A likelihood ratio test assessed the significance of whether the coefficient corresponding to the binary treatment indicator equals to zero.||1.7|0.8|0.5
72414798|NCT03905655|144339727|SUPERIORITY|||||||0.308|||||||t-test, 2 sided|||Comparison of Week 2 values||||0.308
72414799|NCT03905655|144339727|SUPERIORITY|||||||0.794|||||||t-test, 2 sided|||Comparison of Week 4 values||||0.794
72414800|NCT03905655|144339727|SUPERIORITY|||||||0.297|||||||t-test, 2 sided|||Comparison of Week 8 values||||0.297
72414801|NCT03905655|144339727|SUPERIORITY|||||||0.007|||||||t-test, 2 sided|||Comparison of Week 12 values||||0.007
72414802|NCT03905655|144339728|SUPERIORITY|||||||0.123|||||||t-test, 2 sided|||||||0.123
72414803|NCT03905655|144339728|SUPERIORITY|||||||1|||||||t-test, 2 sided|||||||1.000
72414804|NCT03905655|144339728|SUPERIORITY|||||||0.266|||||||t-test, 2 sided|||||||0.266
72414805|NCT02566031|144339729|SUPERIORITY||Mean Difference (Net)|0.05||||0.0129|TWO_SIDED|95.0|0.011|0.093|||ANCOVA|||||0.093|0.011|0.0129
72414806|NCT02566031|144339730|SUPERIORITY||Mean Difference (Net)|0.06||||0.0058|TWO_SIDED|95.0|0.017|0.098|||ANCOVA|||-45 min||0.098|0.017|0.0058
72414807|NCT02566031|144339730|SUPERIORITY||Mean Difference (Net)|0.05||||0.0161|TWO_SIDED|95.0|0.009|0.091|||ANCOVA|||-15min||0.091|0.009|0.0161
72414808|NCT02566031|144339731|SUPERIORITY||Mean Difference (Net)|0.31||||0.0767|TWO_SIDED|95.0|-0.033|0.646|||ANCOVA|||||0.646|-0.033|0.0767
72414809|NCT02566031|144339732|SUPERIORITY||Mean Difference (Net)|-0.81||||0.1008|TWO_SIDED|95.0|-1.77|0.16|||ANCOVA|||||0.16|-1.77|0.1008
72593198|NCT03301740|144718166|EQUIVALENCE|The equivalence margin is the standard error of the estimated differences between UF and standard treatment from the repeated measure mixed model.|Beta coefficient|-2.8||||0.2|TWO_SIDED|95.0|-6.9|1.4||Statistically significant p-value is \<0.05|Mixed Models Analysis|||Null hypothesis = no difference in troponin T change between UF profiling and conventional HD. Repeated measure linear regression was performed, giving each subject a random intercept term. The coefficient is the difference in the outcome between UF profiling and conventional HD.||1.4|-6.9|0.2
72593199|NCT03301740|144718167|EQUIVALENCE|The equivalence margin is the standard error of the estimated differences between UF and standard treatment from the repeated measure mixed model.|Odds Ratio (OR)|0.5||||0.1|TWO_SIDED|95.0|0.2|1.3||Statistically significant p-value is \<0.05|Mixed Models Analysis|||Null hypothesis = no difference in troponin T rise between UF profiling and conventional HD. Likelihood ratio tests were performed using repeated measure logistic regression with the binary treatment indicator as a fixed effect predictor and assigning each subject a random intercept term. A likelihood ratio test assessed the significance of whether the coefficient corresponding to the binary treatment indicator equals to zero.||1.3|0.2|0.1
72593200|NCT03301740|144718168|EQUIVALENCE|The equivalence margin is the standard error of the estimated differences between UF and standard treatment from the repeated measure mixed model.|Mean Difference (Final Values)|-0.8||||0.2|TWO_SIDED|95.0|-2.0|0.5||Statistically significant p-value is \<0.05|Wilcoxon (Mann-Whitney)|||Null hypothesis = no difference in left ventricular GLS change between UF profiling and conventional HD. Wilcoxon (Mann-Whitney) tests were performed assessing the difference of the endpoint between the 2 treatment groups.||0.5|-2.0|0.2
72593201|NCT03301740|144718169|EQUIVALENCE|The equivalence margin is the standard error of the estimated differences between UF and standard treatment from the repeated measure mixed model.|Beta coefficient|-0.2||||0.9|TWO_SIDED|95.0|-2.0|1.7||Statistically significant p-value is \<0.05|Mixed Models Analysis|||Null hypothesis = no difference in nadir systolic BP between UF profiling and conventional HD. Repeated measure linear regression was performed, giving each subject a random intercept term. The coefficient is the difference in the outcome between UF profiling and conventional HD.||1.7|-2.0|0.9
72593202|NCT03301740|144718170|EQUIVALENCE|The equivalence margin is the standard error of the estimated differences between UF and standard treatment from the repeated measure mixed model.|Odds Ratio (OR)|1.0||||0.8|TWO_SIDED|95.0|0.7|1.3||Statistically significant p-value is \<0.05|Mixed Models Analysis|||Null hypothesis = no difference in failed target weight achievement between UF profiling and conventional HD. Likelihood ratio tests were performed using repeated measure logistic regression with the binary treatment indicator as a fixed effect predictor and assigning each subject a random intercept term. A likelihood ratio test assessed the significance of whether the coefficient corresponding to the binary treatment indicator equals to zero.||1.3|0.7|0.8
72414810|NCT00413153|144339734|SUPERIORITY_OR_OTHER|||||||0.035||95.0|||||t-test, 2 sided|||Initial samples size of N=16 calculated to provide 80% power to detect a 30% change in muscle glucose uptake between groups. Student's t-test used to compare change from baseline and determine treatment effect (net difference over time between the ATV/r vs. LPV/r groups).||||0.035
72414811|NCT00413153|144339735|SUPERIORITY_OR_OTHER|||||||0.12||95.0|||||Repeated measures ANCOVA|||Repeated measures ANCOVA, controlling for baseline values, used to assess treatment effect of the randomization over 6 months (net difference over time between ATV/r vs. LPV/r)||||0.12
72414812|NCT00413153|144339736|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||Repeated Measures ANCOVA|||Repeated measures ANCOVA, controlling for baseline values, used to assess treatment effect of the randomization over 6 months (net difference over time between ATV/r vs.LPV/r).||||0.002
72414813|NCT00413153|144339737|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||Repeated measures ANCOVA|||Repeated measures ANCOVA, controlling for baseline values, used to assess treatment effect of the randomization over 6 months (net difference over time between ATV/r vs.LPV/r).||||0.02
72414814|NCT00413153|144339738|SUPERIORITY_OR_OTHER|||||||0.047||95.0|||||t-test, 2 sided|||||||0.047
72593203|NCT03301740|144718171|EQUIVALENCE|The equivalence margin is the standard error of the estimated differences between UF and standard treatment from the repeated measure mixed model.|Odds Ratio (OR)|1.0||||0.9|TWO_SIDED|95.0|0.4|2.1||Statistically significant p-value is \<0.05|Mixed Models Analysis|||Null hypothesis = no difference in clinically important cramping between UF profiling and conventional HD. Likelihood ratio tests were performed using repeated measure logistic regression with the binary treatment indicator as a fixed effect predictor and assigning each subject a random intercept term. A likelihood ratio test assessed the significance of whether the coefficient corresponding to the binary treatment indicator equals to zero.||2.1|0.4|0.9
72414815|NCT00413153|144339739|SUPERIORITY_OR_OTHER|||||||0.72||95.0|||||Repeated Measures ANCOVA|||Repeated measures ANCOVA, controlling for baseline values, used to assess treatment effect of the randomization over 6 months (net difference over time between ATV/r vs.LPV/r).||||0.72
72593204|NCT03301740|144718172|EQUIVALENCE|The equivalence margin is the standard error of the estimated differences between UF and standard treatment from the repeated measure mixed model.|Odds Ratio (OR)|0.7||||0.5|TWO_SIDED|95.0|0.2|2.2||Statistically significant p-value is \<0.05|Mixed Models Analysis|||Null hypothesis = no difference in clinically important nausea/upset stomach between UF profiling and conventional HD. Likelihood ratio tests were performed using repeated measure logistic regression with the binary treatment indicator as a fixed effect predictor and assigning each subject a random intercept term. A likelihood ratio test assessed the significance of whether the coefficient corresponding to the binary treatment indicator equals to zero.||2.2|0.2|0.5
72593205|NCT03301740|144718173|EQUIVALENCE|The equivalence margin is the standard error of the estimated differences between UF and standard treatment from the repeated measure mixed model.|Odds Ratio (OR)|1.0||||1|TWO_SIDED|95.0|0.1|16.0|||Mixed Models Analysis|||Null hypothesis = no difference in clinically important Vomiting/throwing up score between UF profiling and conventional HD. Likelihood ratio tests were performed using repeated measure logistic regression with the binary treatment indicator as a fixed effect predictor and assigning each subject a random intercept term. A likelihood ratio test assessed the significance of whether the coefficient corresponding to the binary treatment indicator equals to zero.||16.0|0.1|1.0
72593206|NCT03301740|144718174|EQUIVALENCE|The equivalence margin is the standard error of the estimated differences between UF and standard treatment from the repeated measure mixed model.|Odds Ratio (OR)|0.2||||0.04|TWO_SIDED|95.0|0.1|0.9||Statistically significant p-value is \<0.05|Mixed Models Analysis|||Null hypothesis = no difference in clinically important dizziness/lightheadedness between UF profiling and conventional HD. Likelihood ratio tests were performed using repeated measure logistic regression with the binary treatment indicator as a fixed effect predictor and assigning each subject a random intercept term. A likelihood ratio test assessed the significance of whether the coefficient corresponding to the binary treatment indicator equals to zero.||0.9|0.1|0.04
72593207|NCT03301740|144718175|EQUIVALENCE|The equivalence margin is the standard error of the estimated differences between UF and standard treatment from the repeated measure mixed model.|Odds Ratio (OR)|3.1||||0.3|TWO_SIDED|95.0|0.3|32.4||Statistically significant p-value is \<0.05|Mixed Models Analysis|||Null hypothesis = no difference in clinically important racing heart/heart palpitations between UF profiling and conventional HD. Likelihood ratio tests were performed using repeated measure logistic regression with the binary treatment indicator as a fixed effect predictor and assigning each subject a random intercept term. A likelihood ratio test assessed the significance of whether the coefficient corresponding to the binary treatment indicator equals to zero.||32.4|0.3|0.3
72593208|NCT03301740|144718176|EQUIVALENCE|The equivalence margin is the standard error of the estimated differences between UF and standard treatment from the repeated measure mixed model.|Odds Ratio (OR)|1.0||||1|TWO_SIDED|95.0|0.2|6.0||Statistically significant p-value is \<0.05|Mixed Models Analysis|||Null hypothesis = no difference in clinically important chest pain between UF profiling and conventional HD. Likelihood ratio tests were performed using repeated measure logistic regression with the binary treatment indicator as a fixed effect predictor and assigning each subject a random intercept term. A likelihood ratio test assessed the significance of whether the coefficient corresponding to the binary treatment indicator equals to zero.||6.0|0.2|1.0
72593209|NCT03301740|144718177|EQUIVALENCE|The equivalence margin is the standard error of the estimated differences between UF and standard treatment from the repeated measure mixed model.|Odds Ratio (OR)|1.3||||0.7|TWO_SIDED|95.0|0.3|6.5||Statistically significant p-value is \<0.05|Mixed Models Analysis|||Null hypothesis = no difference in clinically important shortness of breath between UF profiling and conventional HD. Likelihood ratio tests were performed using repeated measure logistic regression with the binary treatment indicator as a fixed effect predictor and assigning each subject a random intercept term. A likelihood ratio test assessed the significance of whether the coefficient corresponding to the binary treatment indicator equals to zero.||6.5|0.3|0.7
72593210|NCT03301740|144718178|EQUIVALENCE|The equivalence margin is the standard error of the estimated differences between UF and standard treatment from the repeated measure mixed model.|Odds Ratio (OR)|0.6||||0.2|TWO_SIDED|95.0|0.3|1.2||Statistically significant p-value is \<0.05|Mixed Models Analysis|||Null hypothesis = no difference in clinically important thirst/dry mouth between UF profiling and conventional HD. Likelihood ratio tests were performed using repeated measure logistic regression with the binary treatment indicator as a fixed effect predictor and assigning each subject a random intercept term. A likelihood ratio test assessed the significance of whether the coefficient corresponding to the binary treatment indicator equals to zero.||1.2|0.3|0.2
72593211|NCT03301740|144718179|EQUIVALENCE|The equivalence margin is the standard error of the estimated differences between UF and standard treatment from the repeated measure mixed model.|Odds Ratio (OR)|0.9||||0.8|TWO_SIDED|95.0|0.4|2.3||Statistically significant p-value is \<0.05|Mixed Models Analysis|||Null hypothesis = no difference in clinically important headache between UF profiling and conventional HD. Likelihood ratio tests were performed using repeated measure logistic regression with the binary treatment indicator as a fixed effect predictor and assigning each subject a random intercept term. A likelihood ratio test assessed the significance of whether the coefficient corresponding to the binary treatment indicator equals to zero.||2.3|0.4|0.8
72414816|NCT00413153|144339740|SUPERIORITY_OR_OTHER|||||||0.22||95.0|||||Repeated Measures ANCOVA|||Repeated measures ANCOVA, controlling for baseline values, used to assess treatment effect of the randomization over 6 months (net difference over time between ATV/r vs.LPV/r).||||0.22
72593212|NCT03301740|144718180|EQUIVALENCE|The equivalence margin is the standard error of the estimated differences between UF and standard treatment from the repeated measure mixed model.|Odds Ratio (OR)|2.8||||0.02|TWO_SIDED|95.0|1.2|6.6||Statistically significant p-value is \<0.05|Mixed Models Analysis|||Null hypothesis = no difference in clinically important itching between UF profiling and conventional HD. Likelihood ratio tests were performed using repeated measure logistic regression with the binary treatment indicator as a fixed effect predictor and assigning each subject a random intercept term. A likelihood ratio test assessed the significance of whether the coefficient corresponding to the binary treatment indicator equals to zero.||6.6|1.2|0.02
72593213|NCT03301740|144718181|EQUIVALENCE|The equivalence margin is the standard error of the estimated differences between UF and standard treatment from the repeated measure mixed model.|Odds Ratio (OR)|1.2||||0.7|TWO_SIDED|95.0|0.5|2.6||Statistically significant p-value is \<0.05|Mixed Models Analysis|||Null hypothesis = no difference in clinically important restless legs/difficulty keeping legs still between UF profiling and conventional HD. Likelihood ratio tests were performed using repeated measure logistic regression with the binary treatment indicator as a fixed effect predictor and assigning each subject a random intercept term. A likelihood ratio test assessed the significance of whether the coefficient corresponding to the binary treatment indicator equals to zero.||2.6|0.5|0.7
72414817|NCT00413153|144339741|SUPERIORITY_OR_OTHER|||||||0.004||95.0|||||Repeated Measures Ancova|||Repeated measures ANCOVA, controlling for baseline values, used to assess treatment effect of the randomization over 6 months (net difference over time between ATV/r vs.LPV/r).||||0.004
72593214|NCT03301740|144718182|EQUIVALENCE|The equivalence margin is the standard error of the estimated differences between UF and standard treatment from the repeated measure mixed model.|Odds Ratio (OR)|0.6||||0.5|TWO_SIDED|95.0|0.2|2.4||Statistically significant p-value is \<0.05|Mixed Models Analysis|||Null hypothesis = no difference in clinically important tingling/feeling of pins and needles between UF profiling and conventional HD. Likelihood ratio tests were performed using repeated measure logistic regression with the binary treatment indicator as a fixed effect predictor and assigning each subject a random intercept term. A likelihood ratio test assessed the significance of whether the coefficient corresponding to the binary treatment indicator equals to zero.||2.4|0.2|0.5
72593215|NCT01037127|144718183|SUPERIORITY_OR_OTHER||percentage of participants|25.0|||||TWO_SIDED|95.0|14.1|37.8|||||The estimated value reflects the percentage of particpants with CR and PR.|||37.8|14.1|
72593216|NCT01037127|144718184|SUPERIORITY_OR_OTHER||percentage of participants|17.0|||||TWO_SIDED|95.0|2.1|48.4|||||The estimated value reflects the percentage of particpants with CR and PR.|||48.4|2.1|
72593217|NCT01037127|144718184|SUPERIORITY_OR_OTHER||percentage of participants|27.0|||||TWO_SIDED|95.0|14.6|41.9|||||The estimated value reflects the percentage of particpants with CR and PR.|||41.9|14.6|
72593218|NCT01037127|144718184|SUPERIORITY_OR_OTHER||percentage of participants|26.0|||||TWO_SIDED|95.0|14.3|41.4|||||The estimated value reflects the percentage of particpants with CR and PR.|||41.4|14.3|
72593219|NCT01037127|144718184|SUPERIORITY_OR_OTHER||percentage of participants|28.0|||||TWO_SIDED|95.0|14.2|45.2|||||The estimated value reflects the percentage of particpants with CR and PR.|||45.2|14.2|
72593220|NCT01037127|144718185|SUPERIORITY_OR_OTHER||percentage of participants|20.0||||||95.0|7.7|38.6|||||The estimated value reflects the percentage of particpants with CR and PR.|||38.6|7.7|
72593221|NCT02584998|144718197|OTHER||||||<|0.001|||||||Chi-squared|||In our power and sample size analysis, we assumed 15% screening rate in usual care, 25% with invitation, and 40% with mailed-FIT. A sample size of 500 (250/arm) will give 80% power for UC vs. screening invitation-reminder, and 152/arm will give a power of 80% for the screening invitation-reminder vs. mailed-FIT. Accounting for the possibility that up to 20% of participants could be ineligible post-randomization, we concluded that we should enroll 783 patients, 261 per arm, for this trial.||||<0.001
72593222|NCT00962091|144718242|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.9|||||TWO_SIDED|90.0|1.52|2.37|||||The CIs are calculated for the difference in the LS means of the ln-transformed Day 1 Cmax values (difference=OS-PIC). Antilogs of the confidence limits for the difference are taken to construct the CIs for the ratio of the geometric means.|||2.37|1.52|
72593223|NCT00962091|144718243|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.38|||||TWO_SIDED|90.0|1.08|1.78|||||The CIs are calculated for the difference in the LS means of the ln-transformed Day 1 AUClast values (difference=OS-PIC). Antilogs of the confidence limits for the difference are taken to construct the CIs for the ratio of the geometric means.|||1.78|1.08|
72593224|NCT00962091|144718249|SUPERIORITY_OR_OTHER||Geometric mean ratio|0.84|||||TWO_SIDED|90.0|0.66|1.06|||||The CIs are calculated for the difference in the LS means of the ln-transformed Day 1 Cmax values (difference=Fed-Fasted). Antilogs of the confidence limits for the difference are taken to construct the CIs for the ratio of the geometric means.|||1.06|0.66|
72593225|NCT00962091|144718250|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.04|||||TWO_SIDED|90.0|0.8|1.34|||||The CIs are calculated for the difference in the LS means of the ln-transformed Day 1 AUClast values (difference=Fed-Fasted). Antilogs of the confidence limits for the difference are taken to construct the CIs for the ratio of the geometric means.|||1.34|0.80|
72414818|NCT00413153|144339742|SUPERIORITY_OR_OTHER|||||||0.0002||95.0|||||Repeated Measures ANCOVA|||Repeated measures ANCOVA, controlling for baseline values, used to assess treatment effect of the randomization over 6 months (net difference over time between ATV/r vs.LPV/r).||||0.0002
72593226|NCT00962091|144718251|SUPERIORITY_OR_OTHER||Geometric mean ratio|0.94|||||TWO_SIDED|90.0|0.68|1.32|||||The CIs are calculated for the difference in the LS means of the ln-transformed Day 1 AUC values (difference=Fed-Fasted). Antilogs of the confidence limits for the difference are taken to construct the CIs for the ratio of the geometric means.|||1.32|0.68|
72593227|NCT03191864|144718260|SUPERIORITY|||||||0.001|||||||Cochran-Mantel-Haenszel|||||||0.001
72593228|NCT03191864|144718260|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
72593229|NCT03191864|144718260|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
72593230|NCT03191864|144718260|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
72593231|NCT03191864|144718262|OTHER||Mean Difference (Final Values)|-1.28||||0.02|TWO_SIDED|90.0|-2.29|-0.26|||ANCOVA|||Least-squares Mean differences, 90% confidence intervals and 1-sided p-values for comparisons of each APT-1011 dose group to Placebo at Week 12 are from an ANCOVA model||-0.26|-2.29|0.020
72593232|NCT03191864|144718262|OTHER||Mean Difference (Final Values)|-2.08|||<|0.001|TWO_SIDED|90.0|-3.07|-1.1|||ANCOVA|||Least-squares Mean differences, 90% confidence intervals and 1-sided p-values for comparisons of each APT-1011 dose group to Placebo at Week 12 are from an ANCOVA model||-1.10|-3.07|<0.001
72593233|NCT03191864|144718262|OTHER||Mean Difference (Final Values)|-2.25|||<|0.001|TWO_SIDED|90.0|-3.23|-1.26|||ANCOVA|||Least-squares Mean differences, 90% confidence intervals and 1-sided p-values for comparisons of each APT-1011 dose group to Placebo at Week 12 are from an ANCOVA model||-1.26|-3.23|<0.001
72593234|NCT03191864|144718262|OTHER||Mean Difference (Final Values)|-1.59||||0.005|TWO_SIDED|90.0|-2.59|-0.59|||ANCOVA|||Least-squares Mean differences, 90% confidence intervals and 1-sided p-values for comparisons of each APT-1011 dose group to Placebo at Week 12 are from an ANCOVA model||-0.59|-2.59|0.005
72593235|NCT03191864|144718264|OTHER||Mean Difference (Final Values)|-1.19||||0.067|TWO_SIDED|90.0|-2.49|0.12|||ANCOVA|||Least-squares Mean differences, 90% confidence intervals and 1-sided p-values for comparison of each APT-1011 dose group to placebo at Week 12 are from an ANCOVA model.||0.12|-2.49|0.067
72593236|NCT03191864|144718264|OTHER||Mean Difference (Final Values)|0.34||||0.672|TWO_SIDED|90.0|-0.91|1.59|||ANCOVA|||Least-squares Mean differences, 90% confidence intervals and 1-sided p-values for comparison of each APT-1011 dose group to placebo at Week 12 are from an ANCOVA model.||1.59|-0.91|0.672
72593237|NCT03191864|144718264|OTHER||Mean Difference (Final Values)|-1.28||||0.048|TWO_SIDED|90.0|-2.55|-0.01|||ANCOVA|||Least-squares Mean differences, 90% confidence intervals and 1-sided p-values for comparison of each APT-1011 dose group to placebo at Week 12 are from an ANCOVA model.||-0.01|-2.55|0.048
72593238|NCT03191864|144718264|OTHER||Mean Difference (Final Values)|0.31||||0.653|TWO_SIDED|90.0|-0.98|1.59|||ANCOVA|||Least-squares Mean differences, 90% confidence intervals and 1-sided p-values for comparison of each APT-1011 dose group to placebo at Week 12 are from an ANCOVA model.||1.59|-0.98|0.653
72593239|NCT03191864|144718266|SUPERIORITY||Mean Difference (Final Values)|-8.81||||0.079|TWO_SIDED|90.0|-19.06|1.45|||ANCOVA|||EEsAI Total Score Change from Baseline Week 12||1.45|-19.06|0.079
72593240|NCT03191864|144718266|SUPERIORITY||Mean Difference (Final Values)|-5.18||||0.195|TWO_SIDED|90.0|-15.14|4.78|||ANCOVA|||EEsAI Total Score Change from Baseline Week 12||4.78|-15.14|0.195
72593241|NCT03191864|144718266|SUPERIORITY||Mean Difference (Final Values)|-12.56||||0.02|TWO_SIDED|90.0|-22.55|-2.58|||ANCOVA|||EEsAI Total Score Change from Baseline Week 12||-2.58|-22.55|0.020
72593242|NCT03191864|144718266|SUPERIORITY||Mean Difference (Final Values)|-10.61||||0.043|TWO_SIDED|90.0|-20.74|-0.48|||ANCOVA|||EEsAI Total Score Change from Baseline Week 12||-0.48|-20.74|0.043
72593243|NCT03191864|144718267|SUPERIORITY||Mean Difference (Final Values)|-0.21||||0.459|TWO_SIDED|90.0|-3.49|3.08|||ANCOVA|||VDQ Score Change from Baseline Week 12||3.08|-3.49|0.459
72593244|NCT03191864|144718267|SUPERIORITY||Mean Difference (Final Values)|0.58||||0.617|TWO_SIDED|90.0|-2.65|3.8|||ANCOVA|||VDQ Score Change from Baseline Week 12||3.80|-2.65|0.617
72593245|NCT03191864|144718267|SUPERIORITY||Mean Difference (Final Values)|-1.87||||0.167|TWO_SIDED|90.0|-5.07|1.33|||ANCOVA|||VDQ Score Change from Baseline Week 12||1.33|-5.07|0.167
72593246|NCT03191864|144718267|SUPERIORITY||Mean Difference (Final Values)|-0.63||||0.373|TWO_SIDED|90.0|-3.88|2.61|||ANCOVA|||VDQ Score Change from Baseline Week 12||2.61|-3.88|0.373
72593247|NCT03191864|144718267|SUPERIORITY||Mean Difference (Final Values)|-1.66||||0.203|TWO_SIDED|90.0|-4.96|1.64|||ANCOVA|||AMS Score Change from Baseline Week 12||1.64|-4.96|0.203
72593248|NCT03191864|144718267|SUPERIORITY||Mean Difference (Final Values)|-4.33||||0.014|TWO_SIDED|90.0|-7.54|-1.13|||ANCOVA|||AMS Score Change from Baseline Week 12||-1.13|-7.54|0.014
72593249|NCT03191864|144718267|SUPERIORITY||Mean Difference (Final Values)|-3.02||||0.061|TWO_SIDED|90.0|-6.23|0.2|||ANCOVA|||AMS Score Change from Baseline Week 12||0.20|-6.23|0.061
72593250|NCT03191864|144718267|SUPERIORITY||Mean Difference (Final Values)|-2.57||||0.097|TWO_SIDED|90.0|-5.83|0.69|||ANCOVA|||AMS Score Change from Baseline Week 12||0.69|-5.83|0.097
72593251|NCT02086682|144718281|SUPERIORITY|||||||0.79|||||||t-test, 2 sided|||||||0.79
72593252|NCT01047332|144718293|OTHER|||||||0.53|||||||Log Rank|||||||0.530
72593253|NCT01047332|144718294|OTHER|||||||0.997|||||||Log Rank|||||||0.997
72593254|NCT02417961|144718306|SUPERIORITY_OR_OTHER||Percentage|98.2||||||95.0|93.81|99.79|||Clopper-pearson Exact CI|One sample Confidence Interval (Week 12)|Percentage of patients who successfully administered benralizumab with an APFS at home (Week 12)|||99.79|93.81|
72593255|NCT02417961|144718306|SUPERIORITY_OR_OTHER||Percentage|99.1|||||TWO_SIDED|95.0|94.99|99.98|||Clopper-pearson Exact CI|One sample Confidence Interval (Week 16)|Percentage of patients who successfully administered benralizumab with an APFS at home (Week 16)|||99.98|94.99|
72593256|NCT02417961|144718306|SUPERIORITY_OR_OTHER||Percentage|93.0|||||TWO_SIDED|95.0|86.64|96.92|||Clopper-pearson Exact CI|One sample Confidence Interval (Week 12 and 16)|Percentage of patients who successfully administered benralizumab with an APFS at home (Week 12 and 16)|||96.92|86.64|
72593257|NCT02417961|144718307|SUPERIORITY_OR_OTHER||Percentage|99.1|||||TWO_SIDED|95.0|95.21|99.98|||Clopper-pearson Exact CI|One sample Confidence Interval (Week 12)|Percentage of patients returned functional APFS administered at home (Week 12)|||99.98|95.21|
72593258|NCT02417961|144718307|SUPERIORITY_OR_OTHER||Percentage|99.1|||||TWO_SIDED|95.0|94.99|99.98|||Clopper Pearson Exact CI|One sample confidence interval (Week 16)|Percentage of patients returned functional APFS administered at home (Week 16)|||99.98|94.99|
72414819|NCT03204279|144339745|OTHER|No comparison between the two dose groups is performed, thus no statistical test is applied. In the next section the goodness of fit of the loess function correlating exposure and response is reported.|Pearson R|0.076||||0.55|TWO_SIDED|||||CR in the delayed phase vs AUC0-inf|loess (Local regression or polynomial)|The p-value represents the probability found if the correlation coefficient was zero (null hypothesis).|R is the Pearson correlation is a coefficient statistic that measures linear correlation between two variables CR in the delayed phase vs AUC0-inf|The population consist of all patients having CR in the delayed phase and AUC0-inf and Cmax, there is no comparison between the two dose groups.||||0.55
72414820|NCT03204279|144339745|OTHER|No comparison between the two dose groups is performed, thus no statistical test is applied. In the next section the goodness of fit of the loess function correlating exposure and response is reported.|Pearson R|-0.041||||0.75|TWO_SIDED|||||CR in the delayed phase vs Cmax|loess (Local regression or polynomial)|The p-value represents the probability found if the correlation coefficient was zero (null hypothesis).|R is the Pearson correlation is a coefficient statistic that measures linear correlation between two variables CR in the delayed phase vs Cmax|The population consist of all patients having CR in the delayed phase and AUC0-inf and Cmax, there is no comparison between the two dose groups.||||0.75
72593259|NCT02417961|144718308|SUPERIORITY_OR_OTHER||Percentage|0.0|||||TWO_SIDED|95.0|0.0|3.13|||Clopper-pearson Exact CI|One sample Confidence Interval (Week 0)|Percentage of mulfunctioning APFS used to administer benralizumab at home or clinic (Week 0)|||3.13|0.00|
72593260|NCT02417961|144718308|SUPERIORITY_OR_OTHER||Percentage|0.9|||||TWO_SIDED|95.0|0.02|4.67|||Clopper-pearson Exact CI|One sample Confidence Interval (Week 4)|Percentage of malfunctioning APFS used to administer benralizumab at home or clinic (Week 4)|||4.67|0.02|
72593261|NCT02417961|144718308|SUPERIORITY_OR_OTHER||Percentage|0.0|||||TWO_SIDED|95.0|0.0|3.16|||Clopper-pearson Exact CI|One sample Confidence Interval (Week 8)|Percentage of malfunctioning APFS used to administer benralizumab at home or clinic (Week 8)|||3.16|0.00|
72593262|NCT02417961|144718308|SUPERIORITY_OR_OTHER||Percentage|0.0|||||TWO_SIDED|95.0|0.0|3.13|||Clopper-pearson Exact CI|One sample Confidence Interval (Week 12)|Percentage of malfunctioning APFS used to administer benralizumab at home or clinic (Week 12)|||3.13|0.00|
72593263|NCT02417961|144718308|SUPERIORITY_OR_OTHER||Percentage|0.0|||||TWO_SIDED|95.0|0.0|3.33|||Clopper-Pearson Exact CI|One sample Confidence Interval (Week 16)|Percentage of malfunctioning APFS used to administer benralizumab at home or clinic (Week 16)|||3.33|0|
72593264|NCT02417961|144718308|SUPERIORITY_OR_OTHER||Percentage|0.3|||||TWO_SIDED|95.0|0.01|1.59|||Clopper-pearson Exact CI|One sample Confidence Interval (Week 0 to 8)|Percentage of malfunctioning APFS used to administer benralizumab at home or clinic (Week 0 to 8)|||1.59|0.01|
72593265|NCT02417961|144718308|SUPERIORITY_OR_OTHER||Percentage|0.0|||||TWO_SIDED|95.0|0.0|1.63|||Clopper-pearson Exact CI|One sample Confidence Interval (Week 12 to 16)|Percentage of malfunctioning APFS used to administer benralizumab at home or clinic (Week 12 to 16)|||1.63|0.00|
72593266|NCT02417961|144718308|SUPERIORITY_OR_OTHER||Percentage|0.2|||||TWO_SIDED|95.0|0.0|0.97|||Clopper-pearson Exact CI|One sample Confidence Interval (Week 0 to 16)|Percentage of malfunctioning APFS used to administer benralizumab at home or clinic (Week 0 to 16)|||0.97|0.00|
72593267|NCT00715104|144718320|SUPERIORITY_OR_OTHER||% Subjects with 2-fold increase|16.2||||1|TWO_SIDED|95.0|1.7|30.7||Bonferroni-adjusted p-values will be reported to alleviate the multiple testing problem; pbon = minimum of p\*3 and 1 (p = the nominal p-value from the test, pbon = the Bonferroni-adjusted p-value). Confidence intervals will be adjusted similarly.|Chi-squared|||A 2-fold increase in CD3+ T cell counts from biopsy to post-RP was considered a positive response. The number of infiltrating CD3+ T cells/μm2 was coded as binary with each subject categorized as having at least a 2-fold increase from baseline or not. One sample Chi-square test for a binary response, with a null hypothesis of 15% was implemented. The tests were done using post-treatment post-RP benign tissue, tumor tissue, and tumor interface compared to the biopsy benign tissue.||30.7|1.7|1.000
72593268|NCT00715104|144718320|SUPERIORITY_OR_OTHER||% Subjects with 2-fold increase|18.9||||1|TWO_SIDED|95.0|3.5|34.3||Bonferroni-adjusted p-values will be reported to alleviate the multiple testing problem; pbon = minimum of p\*3 and 1 (p = the nominal p-value from the test, pbon = the Bonferroni-adjusted p-value). Confidence intervals will be adjusted similarly.|Chi-squared|||A 2-fold increase in CD3+ T cell counts from biopsy to post-RP was considered a positive response. The number of infiltrating CD3+ T cells/μm2 was coded as binary with each subject categorized as having at least a 2-fold increase from baseline or not. One sample Chi-square test for a binary response, with a null hypothesis of 15% was implemented. The tests were done using post-treatment post-RP benign tissue, tumor tissue, and tumor interface compared to the biopsy benign tissue.||34.3|3.5|1.000
72414821|NCT02479412|144339915|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.02691|STANDARD_ERROR_OF_MEAN|0.05697||0.6379|TWO_SIDED|95.0|-0.08626|0.1401|||Mixed Models Analysis|||AZD7594 58 µg vs. PBO||0.1401|-0.08626|0.6379
72414822|NCT02479412|144339915|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.07604|STANDARD_ERROR_OF_MEAN|0.05663||0.1827|TWO_SIDED|95.0|-0.03645|0.1885|||Mixed Models Analysis|||AZD7594 250 µg vs.PBO||0.1885|-0.03645|0.1827
72414823|NCT02479412|144339915|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1478|STANDARD_ERROR_OF_MEAN|0.05679||0.0108|TWO_SIDED|95.0|0.03494|0.2606|||Mixed Models Analysis|||AZD7594 800 μg vs. PBO||0.2606|0.03494|0.0108
72414824|NCT02479412|144339916|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.857|STANDARD_ERROR_OF_MEAN|3.214||0.1342|TWO_SIDED|95.0|-11.24|1.528|||Mixed Models Analysis|||AZD7594 58 µg vs. PBO||1.528|-11.24|0.1342
72414825|NCT02479412|144339916|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.41|STANDARD_ERROR_OF_MEAN|3.19||0.0016|TWO_SIDED|95.0|-16.75|-4.075|||Mixed Models Analysis|||AZD7594 250 µg vs. PBO||-4.075|-16.75|0.0016
72593269|NCT00715104|144718320|SUPERIORITY_OR_OTHER||% Subjects with 2-fold increase|70.3|||<|0.001|TWO_SIDED|95.0|52.3|88.3||Bonferroni-adjusted p-values will be reported to alleviate the multiple testing problem; pbon = minimum of p\*3 and 1 (p = the nominal p-value from the test, pbon = the Bonferroni-adjusted p-value). Confidence intervals will be adjusted similarly.|Chi-squared|||A 2-fold increase in CD3+ T cell counts from biopsy to post-RP was considered a positive response. The number of infiltrating CD3+ T cells/μm2 was coded as binary with each subject categorized as having at least a 2-fold increase from baseline or not. One sample Chi-square test for a binary response, with a null hypothesis of 15% was implemented. The tests were done using post-treatment post-RP benign tissue, tumor tissue, and tumor interface compared to the biopsy benign tissue.||88.3|52.3|<0.001
72593270|NCT00715104|144718321|SUPERIORITY_OR_OTHER||% subjects with 2-fold increase|20.6||||1|TWO_SIDED|95.0|4.0|37.2||Bonferroni-adjusted p-values will be reported to alleviate the multiple testing problem; pbon = minimum of p\*3 and 1 (p = the nominal p-value from the test, pbon = the Bonferroni-adjusted p-value). Confidence intervals will be adjusted similarly.|Chi-squared|||A 2-fold increase in CD4+ T cell counts from biopsy to post-RP was considered a positive response. The number of infiltrating CD4+ T cells/μm2 was coded as binary with each subject categorized as having at least a 2-fold increase from baseline or not. One sample Chi-square test for a binary response, with a null hypothesis of 15% was implemented. The tests were done using post-treatment post-RP benign tissue, tumor tissue, and tumor interface compared to the biopsy benign tissue.||37.2|4.0|1.000
72593271|NCT00715104|144718321|SUPERIORITY_OR_OTHER||% subjects with 2-fold increase|32.4||||0.014|TWO_SIDED|95.0|13.1|51.6||Bonferroni-adjusted p-values will be reported to alleviate the multiple testing problem; pbon = minimum of p\*3 and 1 (p = the nominal p-value from the test, pbon = the Bonferroni-adjusted p-value). Confidence intervals will be adjusted similarly.|Chi-squared|||A 2-fold increase in CD4+ T cell counts from biopsy to post-RP was considered a positive response. The number of infiltrating CD4+ T cells/μm2 was coded as binary with each subject categorized as having at least a 2-fold increase from baseline or not. One sample Chi-square test for a binary response, with a null hypothesis of 15% was implemented. The tests were done using post-treatment post-RP benign tissue, tumor tissue, and tumor interface compared to the biopsy benign tissue.||51.6|13.1|0.014
72593272|NCT00715104|144718321|SUPERIORITY_OR_OTHER||% subjects with 2-fold increase|79.4|||<|0.001|TWO_SIDED|95.0|62.8|96.0||Bonferroni-adjusted p-values will be reported to alleviate the multiple testing problem; pbon = minimum of p\*3 and 1 (p = the nominal p-value from the test, pbon = the Bonferroni-adjusted p-value). Confidence intervals will be adjusted similarly.|Chi-squared|||A 2-fold increase in CD4+ T cell counts from biopsy to post-RP was considered a positive response. The number of infiltrating CD4+ T cells/μm2 was coded as binary with each subject categorized as having at least a 2-fold increase from baseline or not. One sample Chi-square test for a binary response, with a null hypothesis of 15% was implemented. The tests were done using post-treatment post-RP benign tissue, tumor tissue, and tumor interface compared to the biopsy benign tissue.||96.0|62.8|<0.001
72593273|NCT00715104|144718322|SUPERIORITY_OR_OTHER||% subjects with 2-fold increase|35.1||||0.002|TWO_SIDED|95.0|16.3|53.9||Bonferroni-adjusted p-values will be reported to alleviate the multiple testing problem; pbon = minimum of p\*3 and 1 (p = the nominal p-value from the test, pbon = the Bonferroni-adjusted p-value). Confidence intervals will be adjusted similarly.|Chi-squared|||A 2-fold increase in CD8+ T cell counts from biopsy to post-RP was considered a positive response. The number of infiltrating CD8+ T cells/μm2 was coded as binary with each subject categorized as having at least a 2-fold increase from baseline or not. One sample Chi-square test for a binary response, with a null hypothesis of 15% was implemented. The tests were done using post-treatment post-RP benign tissue, tumor tissue, and tumor interface compared to the biopsy benign tissue.||53.9|16.3|0.002
72593274|NCT00715104|144718322|SUPERIORITY_OR_OTHER||% subjects with 2-fold increase|29.7||||0.036|TWO_SIDED|95.0|11.7|47.7||Bonferroni-adjusted p-values will be reported to alleviate the multiple testing problem; pbon = minimum of p\*3 and 1 (p = the nominal p-value from the test, pbon = the Bonferroni-adjusted p-value). Confidence intervals will be adjusted similarly.|Chi-squared|||A 2-fold increase in CD8+ T cell counts from biopsy to post-RP was considered a positive response. The number of infiltrating CD8+ T cells/μm2 was coded as binary with each subject categorized as having at least a 2-fold increase from baseline or not. One sample Chi-square test for a binary response, with a null hypothesis of 15% was implemented. The tests were done using post-treatment post-RP benign tissue, tumor tissue, and tumor interface compared to the biopsy benign tissue.||47.7|11.7|0.036
72593275|NCT00715104|144718322|SUPERIORITY_OR_OTHER||% subjects with 2-fold increase|83.8|||<|0.001|TWO_SIDED|95.0|69.3|98.3||Bonferroni-adjusted p-values will be reported to alleviate the multiple testing problem; pbon = minimum of p\*3 and 1 (p = the nominal p-value from the test, pbon = the Bonferroni-adjusted p-value). Confidence intervals will be adjusted similarly.|Chi-squared|||A 2-fold increase in CD8+ T cell counts from biopsy to post-RP was considered a positive response. The number of infiltrating CD8+ T cells/μm2 was coded as binary with each subject categorized as having at least a 2-fold increase from baseline or not. One sample Chi-square test for a binary response, with a null hypothesis of 15% was implemented. The tests were done using post-treatment post-RP benign tissue, tumor tissue, and tumor interface compared to the biopsy benign tissue.||98.3|69.3|<0.001
72414826|NCT02479412|144339916|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.75|STANDARD_ERROR_OF_MEAN|3.236|<|0.0001|TWO_SIDED|95.0|-21.18|-8.319|||Mixed Models Analysis|||AZD7594 800 µg vs. PBO||-8.319|-21.18|<0.0001
72414827|NCT02479412|144339917|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.85|STANDARD_ERROR_OF_MEAN|5.139||0.0084|TWO_SIDED|95.0|-24.06|-3.642|||Mixed Models Analysis|||AZD7594 58 µg vs. PBO||-3.642|-24.06|0.0084
72414828|NCT02479412|144339917|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.26|STANDARD_ERROR_OF_MEAN|5.088||0.0062|TWO_SIDED|95.0|-24.37|-4.149|||Mixed Models Analysis|||AZD7594 250 µg vs. PBO||-4.149|-24.37|0.0062
72593276|NCT00715104|144718323|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||P value is for the visit effect in the mixed model|Mixed Models Analysis|Randomization groups, visits (up to 12-weeks Post-RP), and randomization groups × visits interaction were included in the mixed model.||The change over time was evaluated by using repeated measure analysis of variance (ANOVA) methods with a mixed model approach. The ranked data were used in the statistical model.||||<0.001
72593277|NCT00715104|144718324|SUPERIORITY_OR_OTHER|||||||0.173|TWO_SIDED|||||P value is for the visit effect in the mixed model|Mixed Models Analysis|Randomization groups, visits (up to 12-weeks Post-RP), and randomization groups × visits interaction were included in the mixed model.||Repeated measure analysis of variance (ANOVA) methods with a mixed model approach was used. The ranked data were used in the statistical model.||||0.173
72593278|NCT00715104|144718325|SUPERIORITY_OR_OTHER|||||||0.667|TWO_SIDED|||||P value compares 24 week post-RP to pre-booster (12 weeks post RP)|Mixed Models Analysis|||The change over time was evaluated by using repeated measure analysis of variance (ANOVA) methods with a mixed model approach to allow for a varying number of follow-up measurements. The ranked data were used in the statistical model.||||0.667
72593279|NCT00715104|144718325|SUPERIORITY_OR_OTHER|||||||0.191|TWO_SIDED|||||P value compares 48 week post-RP to pre-booster (12 weeks post RP)|Mixed Models Analysis|||The change over time was evaluated by using repeated measure analysis of variance (ANOVA) methods with a mixed model approach to allow for a varying number of follow-up measurements. The ranked data were used in the statistical model.||||0.191
72593280|NCT00715104|144718325|SUPERIORITY_OR_OTHER|||||||0.699|TWO_SIDED|||||P value compares 72 week post-RP to pre-booster (12 weeks post RP)|Mixed Models Analysis|||The change over time was evaluated by using repeated measure analysis of variance (ANOVA) methods with a mixed model approach to allow for a varying number of follow-up measurements. The ranked data were used in the statistical model.||||0.699
72593281|NCT00715104|144718326|SUPERIORITY_OR_OTHER|||||||0.086|TWO_SIDED|||||P value compares 24 week post-RP to pre-booster (12 weeks post RP)|Mixed Models Analysis|||The change over time was evaluated by using repeated measure analysis of variance (ANOVA) methods with a mixed model approach to allow for a varying number of follow-up measurements. The ranked data were used in the statistical model.||||0.086
72593282|NCT00715104|144718326|SUPERIORITY_OR_OTHER|||||||0.432|TWO_SIDED|||||P value compares 48 week post-RP to pre-booster (12 weeks post RP)|Mixed Models Analysis|||The change over time was evaluated by using repeated measure analysis of variance (ANOVA) methods with a mixed model approach to allow for a varying number of follow-up measurements. The ranked data were used in the statistical model.||||0.432
72593283|NCT00715104|144718326|SUPERIORITY_OR_OTHER|||||||0.249|TWO_SIDED|||||P value compares 72 week post-RP to pre-booster (12 weeks post RP)|Mixed Models Analysis|||The change over time was evaluated by using repeated measure analysis of variance (ANOVA) methods with a mixed model approach to allow for a varying number of follow-up measurements. The ranked data were used in the statistical model.||||0.249
72593284|NCT00715104|144718327|SUPERIORITY_OR_OTHER|||||||0.95|TWO_SIDED|||||P value is based on the treatment effect in the mixed model|Mixed Models Analysis|Mixed model includes randomization group, visit, and randomization group × visit interaction, with subject as a random effect.||The change over time was evaluated by using repeated measure analysis of variance (ANOVA) methods with a mixed model approach. The ranked data were used in the statistical model.||||0.950
72593285|NCT00715104|144718328|SUPERIORITY_OR_OTHER|||||||0.048|TWO_SIDED|||||P value is based on the treatment effect in the mixed model|Mixed Models Analysis|Mixed model includes randomization group, visit, and randomization group × visit interaction, with subject as a random effect||The change over time was evaluated by using repeated measure analysis of variance (ANOVA) methods with a mixed model approach. The ranked data were used in the statistical model.||||0.048
72593286|NCT02059434|144718330|SUPERIORITY_OR_OTHER||Least squares mean difference|0.104|STANDARD_ERROR_OF_MEAN|0.023|<|0.0001|TWO_SIDED|95.0|0.06|0.149||All statistical comparisons were two-sided hypothesis tests, and the significance level was set at 0.05 without multiplicity adjustment|ANCOVA|||Change from baseline to trough FEV1 was analyzed by means of an analysis of covariance (ANCOVA) for cross-over designs with sequence, treatment group and period as fixed effect factors, subject within sequence as random effect, and screening and baseline FEV1 value of each period as covariates||0.149|0.060|<0.0001
72593287|NCT02059434|144718330|SUPERIORITY_OR_OTHER||Least squares mean difference|0.178|STANDARD_ERROR_OF_MEAN|0.023|<|0.0001|TWO_SIDED|95.0|0.133|0.223||All statistical comparisons were two-sided hypothesis tests, and the significance level was set at 0.05 without multiplicity adjustment|ANCOVA|||Change from baseline to trough FEV1 was analyzed by means of an analysis of covariance (ANCOVA) for cross-over designs with sequence, treatment group and period as fixed effect factors, subject within sequence as random effect, and screening and baseline FEV1 value of each period as covariates||0.223|0.133|<0.0001
72414829|NCT02479412|144339917|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.9|STANDARD_ERROR_OF_MEAN|5.137||0.0002|TWO_SIDED|95.0|-30.1|-9.689|||Mixed Models Analysis|||AZD7594 800 µg vs. PBO||-9.689|-30.10|0.0002
72414830|NCT02479412|144339918|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.03051|STANDARD_ERROR_OF_MEAN|0.05856||0.6036|TWO_SIDED|95.0|-0.08579|0.1468|||Mixed Models Analysis|||AZD7594 58 μg vs. PBO||0.1468|-0.08579|0.6036
72593288|NCT00771264|144718337|SUPERIORITY_OR_OTHER|||||||0.05||95.0||||P-values \<0.05 were considered statistically significant.|t-test, 2 sided|Mean values were analyzed for significant change using a 2-sided paired t-test and proportions were analyzed using chi-square methodology.||Mean values were analyzed for significant change using a 2-sided paired t test and proportions were analyzed using chi-square methodology. Median values were analyzed using a Wilcoxon signed rank test with p\<0.05 considered statistically significant. A sample size estimate of 214 subjects, 107 per arm, was calculated using a 2-sided Fisher's exact binomial test based on an estimated 60% responder rate in the PTNS group and a 40% in the sham group with a 5% significance level and 80% power.||||0.05
72593289|NCT02928770|144718342|OTHER|||||||0.0559|||||||t-test, 2 sided|Comparison between baseline and experimental (Nastent) conditions||||||0.0559
72593290|NCT01752634|144718374|SUPERIORITY||Odds Ratio (OR)|2.32||||0.02|TWO_SIDED|95.0|1.14|4.73|||Regression, Logistic|||||4.73|1.14|0.0200
72593291|NCT01752634|144718374|SUPERIORITY||Odds Ratio (OR)|6.52|||<|1|TWO_SIDED|95.0|3.25|13.08|||Regression, Logistic|||||13.08|3.25|<0001
72593292|NCT01752634|144718374|SUPERIORITY||Odds Ratio (OR)|6.81|||<|0.0001|TWO_SIDED|95.0|3.42|13.56|||Regression, Logistic|||||13.56|3.42|<.0001
72593293|NCT01752634|144718375|SUPERIORITY||Odds Ratio (OR)|2.07||||0.165|TWO_SIDED|95.0|0.74|5.81|||Regression, Logistic|||||5.81|0.74|0.1650
72593294|NCT01752634|144718375|SUPERIORITY||Odds Ratio (OR)|5.7||||0.0006|TWO_SIDED|95.0|2.12|15.34|||Regression, Logistic|||||15.34|2.12|0.0006
72593295|NCT01752634|144718375|SUPERIORITY||Odds Ratio (OR)|9.48|||<|0.0001|TWO_SIDED|95.0|3.33|27.0|||Regression, Logistic|||||27.00|3.33|<.0001
72593296|NCT01752634|144718376|SUPERIORITY||Odds Ratio (OR)|1.38||||0.6421|TWO_SIDED|95.0|0.36|5.36|||Regression, Logistic|||||5.36|0.36|0.6421
72593297|NCT01752634|144718376|SUPERIORITY||Odds Ratio (OR)|6.36||||0.0029|TWO_SIDED|95.0|1.89|21.47|||Regression, Logistic|||||21.47|1.89|0.0029
72593298|NCT01752634|144718376|SUPERIORITY||Odds Ratio (OR)|10.74||||0.0002|TWO_SIDED|95.0|3.13|36.84|||Regression, Logistic|||||36.84|3.13|0.0002
72593299|NCT01752634|144718377|SUPERIORITY||Mean Difference (Net)|-0.16||||0.3763|TWO_SIDED|95.0|-0.53|0.2|||Mixed Models Analysis|||||0.20|-0.53|0.3763
72593300|NCT01752634|144718377|SUPERIORITY||Mean Difference (Net)|-0.62||||0.0008|TWO_SIDED|95.0|-0.98|-0.26|||Mixed Models Analysis|||||-0.26|-0.98|0.0008
72593301|NCT01752634|144718377|SUPERIORITY||Mean Difference (Net)|-0.65||||0.0004|TWO_SIDED|95.0|-1.02|-0.29|||Mixed Models Analysis|||||-0.29|-1.02|0.0004
72593302|NCT01752634|144718378|SUPERIORITY||Mean Difference (Net)|2.42||||0.0482|TWO_SIDED|95.0|0.02|4.83|||Mixed Models Analysis|||||4.83|0.02|0.0482
72593303|NCT01752634|144718378|SUPERIORITY||Mean Difference (Net)|4.44||||0.0003|TWO_SIDED|95.0|2.05|6.83|||Mixed Models Analysis|||||6.83|2.05|0.0003
72593304|NCT01752634|144718378|SUPERIORITY||Mean Difference (Net)|5.3|||<|0.0001|TWO_SIDED|95.0|2.91|7.69|||Mixed Models Analysis|||||7.69|2.91|<0.0001
72593305|NCT01752634|144718379|SUPERIORITY||Mean Difference (Net)|-0.01||||0.9195|TWO_SIDED|95.0|-0.16|0.15|||Mixed Models Analysis|||||0.15|-0.16|0.9195
72593306|NCT01752634|144718379|SUPERIORITY||Mean Difference (Net)|-0.17||||0.0278|TWO_SIDED|95.0|-0.32|-0.02|||Mixed Models Analysis|||||-0.02|-0.32|0.0278
72593307|NCT01752634|144718379|SUPERIORITY||Mean Difference (Net)|-0.25||||0.0013|TWO_SIDED|95.0|-0.4|-0.1|||Mixed Models Analysis|||||-0.10|-0.40|0.0013
72593308|NCT01752634|144718380|SUPERIORITY||Odds Ratio (OR)|2.91||||0.0245|TWO_SIDED|95.0|1.15|7.36|||Regression, Logistic|||||7.36|1.15|0.0245
72593309|NCT01752634|144718380|SUPERIORITY||Odds Ratio (OR)|7.54|||<|0.0001|TWO_SIDED|95.0|3.11|18.25|||Regression, Logistic|||||18.25|3.11|<.0001
72593310|NCT01752634|144718380|SUPERIORITY||Odds Ratio (OR)|7.15|||<|0.0001|TWO_SIDED|95.0|2.97|17.22|||Regression, Logistic|||||17.22|2.97|<.0001
72593311|NCT01752634|144718381|SUPERIORITY||Odds Ratio (OR)|0.51||||0.3149|TWO_SIDED|95.0|0.13|1.91|||Regression, Logistic|||||1.91|0.13|0.3149
72593312|NCT01752634|144718381|SUPERIORITY||Odds Ratio (OR)|0.16||||0.0056|TWO_SIDED|95.0|0.04|0.58|||Regression, Logistic|||||0.58|0.04|0.0056
72593313|NCT01752634|144718381|SUPERIORITY||Odds Ratio (OR)|0.14||||0.0021|TWO_SIDED|95.0|0.04|0.5|||Regression, Logistic|||||0.50|0.04|0.0021
72593314|NCT01752634|144718382|SUPERIORITY||Odds Ratio (OR)|0.58||||0.1678|TWO_SIDED|95.0|0.26|1.26|||Regression, Logistic|||||1.26|0.26|0.1678
72593315|NCT01752634|144718382|SUPERIORITY||Odds Ratio (OR)|0.36||||0.0108|TWO_SIDED|95.0|0.17|0.79|||Regression, Logistic|||||0.79|0.17|0.0108
72593316|NCT01752634|144718382|SUPERIORITY||Odds Ratio (OR)|0.29||||0.0025|TWO_SIDED|95.0|0.13|0.65|||Regression, Logistic|||||0.65|0.13|0.0025
72593317|NCT04599933|144718417|SUPERIORITY||Odds Ratio (OR)|2.916|||<|0.01|TWO_SIDED|95.0|1.663|5.113|||Regression, Logistic|||All treatment comparisons for primary and secondary endpoints related to BDCVA were conducted with a logistic regression model including fixed effects of baseline BDCVA at 40 cm as a covariate and treatment.||5.113|1.663|<0.01
72593318|NCT04599933|144718418|SUPERIORITY||Odds Ratio (OR)|3.035|||<|0.01|TWO_SIDED|95.0|1.736|5.305|||Regression, Logistic|||||5.305|1.736|<0.01
72593319|NCT04599933|144718419|SUPERIORITY||Odds Ratio (OR)|4.751|||<|0.01|TWO_SIDED|95.0|2.694|8.379|||Regression, Logistic|||||8.379|2.694|<0.01
72593320|NCT04599933|144718420|SUPERIORITY||Odds Ratio (OR)|3.422|||<|0.01|TWO_SIDED|95.0|1.923|6.09|||Regression, Logistic|||||6.090|1.923|<0.01
72593321|NCT05014815|144718469|SUPERIORITY||Hazard Ratio (HR)|0.99||||0.4698|TWO_SIDED|95.0|0.74|1.33||1-sided p-value|Log Rank|Stratified by PD-L1 expression (\<1% of tumor cells (TC) vs 1-49% TC vs \>= 50% TC) and histology (squamous vs non-squamous).|The HR and its 95% confidence interval (CI) was estimated using a Cox regression model stratified by PD-L1 expression (\<1% of tumor cells (TC) vs 1-49% TC vs \>= 50% TC) and histology (squamous vs non-squamous).|||1.33|0.74|0.4698
72593322|NCT05014815|144718470|OTHER||Odds Ratio (OR)|0.77|||||TWO_SIDED|95.0|0.47|1.26|||||The Mantel-Haenszel common OR and its 95% CI were estimated using a normal approximation of the log odds ratio and the Robins-Breslow-Greenland variance, stratified by PD-L1 expression and histology.|||1.26|0.47|
72593323|NCT05014815|144718472|OTHER||Hazard Ratio (HR)|0.95|||||TWO_SIDED|95.0|0.67|1.34|||||The HR and its 95% confidence interval (CI) was estimated using a Cox regression model stratified by PD-L1 expression (\<1% of tumor cells (TC) vs 1-49% TC vs \>= 50% TC) and histology (squamous vs non-squamous).|||1.34|0.67|
72414831|NCT02479412|144339918|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01744|STANDARD_ERROR_OF_MEAN|0.05869||0.767|TWO_SIDED|95.0|-0.09912|0.134|||Mixed Models Analysis|||AZD7594 250 μg vs. PBO||0.1340|-0.09912|0.7670
72414832|NCT02479412|144339918|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1561|STANDARD_ERROR_OF_MEAN|0.05874||0.0093|TWO_SIDED|95.0|0.03943|0.2728|||Mixed Models Analysis|||AZD7594 800 μg vs. PBO||0.2728|0.03943|0.0093
72414833|NCT02479412|144339919|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.03467|STANDARD_ERROR_OF_MEAN|0.05377||0.5207|TWO_SIDED|95.0|-0.1415|0.07213|||Mixed Models Analysis|||AZD7594 58 μg vs. PBO||0.07213|-0.1415|0.5207
72414834|NCT02479412|144339919|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.02821|STANDARD_ERROR_OF_MEAN|0.05336||0.5983|TWO_SIDED|95.0|-0.07778|0.1342|||Mixed Models Analysis|||AZD7594 250 μg vs. PBO||0.1342|-0.07778|0.5983
72414835|NCT02479412|144339919|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.06169|STANDARD_ERROR_OF_MEAN|0.05371||0.2538|TWO_SIDED|95.0|-0.04501|0.1684|||Mixed Models Analysis|||AZD7594 800 μg vs. PBO||0.1684|-0.04501|0.2538
72414836|NCT02479412|144339920|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02262|STANDARD_ERROR_OF_MEAN|0.05743||0.6945|TWO_SIDED|95.0|-0.1367|0.09144|||Mixed Models Analysis|||AZD7594 58 μg vs. PBO||0.09144|-0.1367|0.6945
72414837|NCT02479412|144339920|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.000314|STANDARD_ERROR_OF_MEAN|0.05755||0.9957|TWO_SIDED|95.0|-0.1146|0.114|||Mixed Models Analysis|||AZD7594 250 μg vs. PBO||0.1140|-0.1146|0.9957
72414838|NCT02479412|144339920|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.06831|STANDARD_ERROR_OF_MEAN|0.05774||0.2398|TWO_SIDED|95.0|-0.04637|0.183|||Mixed Models Analysis|||AZD7594 800 μg vs. PBO||0.1830|-0.04637|0.2398
72593324|NCT02453282|144718480|SUPERIORITY||Hazard Ratio (HR)|0.76||||0.036|TWO_SIDED|97.54|0.564|1.019||The 2-sided p-value was calculated using a stratified log-rank test adjusting for histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Log Rank||The HR and confidence interval (CI) were calculated using a stratified Cox proportional hazards model, adjusting for histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Durvalumab Monotherapy Vs SoC Chemotherapy||1.019|0.564|0.036
72593325|NCT02453282|144718480|SUPERIORITY||Hazard Ratio (HR)|0.85||||0.202|TWO_SIDED|98.77|0.611|1.173||The 2-sided p-value was calculated using a stratified log-rank test adjusting for histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Log Rank||The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Durvalumab + Tremelimumab Vs SoC Chemotherapy||1.173|0.611|0.202
72593326|NCT02453282|144718481|SUPERIORITY||Hazard Ratio (HR)|1.05||||0.705|TWO_SIDED|99.5|0.722|1.534||The analysis was performed using stratified log-rank test adjusting for histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Log Rank||The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Durvalumab + Tremelimumab Vs SoC Chemotherapy||1.534|0.722|0.705
72593327|NCT02453282|144718482|SUPERIORITY||Hazard Ratio (HR)|1.09||||0.523|TWO_SIDED|95.0|0.836|1.421||The 2-sided p-value was calculated using a stratified log-rank test adjusting for histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Log Rank||The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Durvalumab + Tremelimumab Vs Durvalumab Monotherapy||1.421|0.836|0.523
72593328|NCT02453282|144718483|SUPERIORITY||Hazard Ratio (HR)|0.88||||0.194|TWO_SIDED|95.0|0.725|1.067||The 2-sided p-value was calculated using a stratified log-rank test adjusting for PD-L1 status (\>=25% Vs \<25%) and histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Log Rank||The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for PD-L1 status (\>=25% Vs \<25%) and histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Durvalumab Monotherapy Vs SoC Chemotherapy||1.067|0.725|0.194
72593329|NCT02453282|144718483|SUPERIORITY||Hazard Ratio (HR)|1.01||||0.952|TWO_SIDED|95.0|0.834|1.213||The 2-sided p-value was calculated using a stratified log-rank test adjusting for PD-L1 status (\>=25% Vs \<25%) and histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Log Rank||The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for PD-L1 status (\>=25% Vs \<25%) and histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Durvalumab + Tremelimumab Vs SoC Chemotherapy||1.213|0.834|0.952
72593330|NCT02453282|144718483|SUPERIORITY||Hazard Ratio (HR)|1.13||||0.218|TWO_SIDED|95.0|0.931|1.371||The 2-sided p-value was calculated using a stratified log-rank test adjusting for PD-L1 status (\>=25% Vs \<25%) and histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Log Rank||The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for PD-L1 status (\>=25% Vs \<25%) and histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Durvalumab + Tremelimumab Vs Durvalumab Monotherapy||1.371|0.931|0.218
72414839|NCT02479412|144339921|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.34|STANDARD_ERROR_OF_MEAN|5.877||0.0819|TWO_SIDED|95.0|-1.335|22.01|||Mixed Models Analysis|||AZD7594 58 μg vs. PBO||22.01|-1.335|0.0819
72593331|NCT02453282|144718484|SUPERIORITY||Hazard Ratio (HR)|0.96||||0.602|TWO_SIDED|95.0|0.812|1.128||The 2-sided p-value was calculated using a stratified log-rank test adjusting for PD-L1 status (\>=25% Vs \<25%) and histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Log Rank||The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for PD-L1 status (\>=25% Vs \<25%) and histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Durvalumab Monotherapy Vs SoC Chemotherapy||1.128|0.812|0.602
72593332|NCT02453282|144718484|SUPERIORITY||Hazard Ratio (HR)|0.94||||0.43|TWO_SIDED|95.0|0.794|1.103||The 2-sided p-value was calculated using a stratified log-rank test adjusting for PD-L1 status (\>=25% Vs \<25%) and histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Log Rank||The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for PD-L1 status (\>=25% Vs \<25%) and histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Durvalumab + Tremelimumab Vs SoC Chemotherapy||1.103|0.794|0.430
72593333|NCT02453282|144718484|SUPERIORITY||Hazard Ratio (HR)|0.98||||0.802|TWO_SIDED|95.0|0.828|1.157||The 2-sided p-value was calculated using a stratified log-rank test adjusting for PD-L1 status (\>=25% Vs \<25%) and histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Log Rank||The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for PD-L1 status (\>=25% Vs \<25%) and histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Durvalumab + Tremelimumab Vs Durvalumab Monotherapy||1.157|0.828|0.802
72593334|NCT02453282|144718485|SUPERIORITY||Hazard Ratio (HR)|0.87||||0.324|TWO_SIDED|95.0|0.667|1.143||The analysis was performed using stratified log-rank test adjusting for histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Log Rank||The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Durvalumab Monotherapy Vs SoC Chemotherapy||1.143|0.667|0.324
72593335|NCT02453282|144718485|SUPERIORITY||Hazard Ratio (HR)|1.18||||0.207|TWO_SIDED|95.0|0.911|1.541||The analysis was performed using stratified log-rank test adjusting for histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Log Rank||The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Durvalumab + Tremelimumab Vs Durvalumab Monotherapy||1.541|0.911|0.207
72593336|NCT02453282|144718486|SUPERIORITY||Hazard Ratio (HR)|1.09||||0.383|TWO_SIDED|95.0|0.894|1.339||The analysis was performed using stratified log-rank test adjusting for PD-L1 status (\>=25% Vs \<25%) and histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Log Rank||The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for PD-L1 status (\>=25% Vs \<25%) and histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Durvalumab Monotherapy Vs SoC Chemotherapy||1.339|0.894|0.383
72414840|NCT02479412|144339921|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.253|STANDARD_ERROR_OF_MEAN|5.881||0.3741|TWO_SIDED|95.0|-6.427|16.93|||Mixed Models Analysis|||AZD7594 250 μg vs. PBO||16.93|-6.427|0.3741
72414841|NCT02479412|144339921|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.52|STANDARD_ERROR_OF_MEAN|5.926||0.0374|TWO_SIDED|95.0|0.7481|24.29|||Mixed Models Analysis|||AZD7594 800 μg vs. PBO||24.29|0.7481|0.0374
72414842|NCT02479412|144339922|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|15.73|STANDARD_ERROR_OF_MEAN|5.384||0.0044|TWO_SIDED|95.0|5.039|26.43|||Mixed Models Analysis|||AZD7594 58 μg vs. PBO||26.43|5.039|0.0044
72414843|NCT02479412|144339922|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.3|STANDARD_ERROR_OF_MEAN|5.419||0.0098|TWO_SIDED|95.0|3.534|25.06|||Mixed Models Analysis|||AZD7594 250 μg vs. PBO||25.06|3.534|0.0098
72414844|NCT02479412|144339922|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|19.91|STANDARD_ERROR_OF_MEAN|5.459||0.0004|TWO_SIDED|95.0|9.068|30.75|||Mixed Models Analysis|||AZD7594 800 μg vs. PBO||30.75|9.068|0.0004
72593337|NCT02453282|144718486|SUPERIORITY||Hazard Ratio (HR)|1.38||||0.001|TWO_SIDED|95.0|1.136|1.678||The analysis was performed using stratified log-rank test adjusting for PD-L1 status (\>=25% Vs \<25%) and histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Log Rank||The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for PD-L1 status (\>=25% Vs \<25%) and histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Durvalumab + Tremelimumab Vs SoC Chemotherapy||1.678|1.136|0.001
72593338|NCT02453282|144718486|SUPERIORITY||Hazard Ratio (HR)|1.16||||0.138|TWO_SIDED|95.0|0.954|1.403||The analysis was performed using stratified log-rank test adjusting for PD-L1 status (\>=25% Vs \<25%) and histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Log Rank||The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for PD-L1 status (\>=25% Vs \<25%) and histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Durvalumab + Tremelimumab Vs Durvalumab Monotherapy||1.403|0.954|0.138
72593339|NCT02453282|144718487|SUPERIORITY||Hazard Ratio (HR)|1.24||||0.015|TWO_SIDED|95.0|1.043|1.475||The analysis was performed using stratified log-rank test adjusting for PD-L1 status (\>=25% Vs \<25%) and histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Log Rank||The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for PD-L1 status (\>=25% Vs \<25%) and histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Durvalumab Monotherapy Vs SoC Chemotherapy||1.475|1.043|0.015
72593340|NCT02453282|144718487|SUPERIORITY||Hazard Ratio (HR)|1.25||||0.01|TWO_SIDED|95.0|1.054|1.485||The analysis was performed using stratified log-rank test adjusting for PD-L1 status (\>=25% Vs \<25%) and histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Log Rank||The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for PD-L1 status (\>=25% Vs \<25%) and histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Durvalumab + Tremelimumab Vs SoC Chemotherapy||1.485|1.054|0.010
72593341|NCT02453282|144718487|SUPERIORITY||Hazard Ratio (HR)|1.0||||0.984|TWO_SIDED|95.0|0.845|1.179||The analysis was performed using stratified log-rank test adjusting for PD-L1 status (\>=25% Vs \<25%) and histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Log Rank||The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for PD-L1 status (\>=25% Vs \<25%) and histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Durvalumab + Tremelimumab Vs Durvalumab Monotherapy||1.179|0.845|0.984
72593342|NCT02453282|144718488|SUPERIORITY||Odds Ratio (OR)|0.91||||0.698|TWO_SIDED|95.0|0.582|1.437||P-value is based on twice the change in log-likelihood resulting from the addition of a treatment factor to the model.|Regression, Logistic||The analysis was performed using logistic regression adjusting for histology (squamous Vs non-squamous), with 95% CI calculated by profile likelihood.|Durvalumab Monotherapy Vs SoC Chemotherapy||1.437|0.582|0.698
72593343|NCT02453282|144718488|SUPERIORITY||Odds Ratio (OR)|0.87||||0.534|TWO_SIDED|95.0|0.549|1.363||P-value is based on twice the change in log-likelihood resulting from the addition of a treatment factor to the model.|Regression, Logistic||The analysis was performed using logistic regression adjusting for histology (squamous Vs non-squamous), with 95% CI calculated by profile likelihood.|Durvalumab + Tremelimumab Vs SoC Chemotherapy||1.363|0.549|0.534
72593344|NCT02453282|144718488|SUPERIORITY||Odds Ratio (OR)|0.95||||0.82|TWO_SIDED|95.0|0.601|1.496||P-value is based on twice the change in log-likelihood resulting from the addition of a treatment factor to the model.|Regression, Logistic||The analysis was performed using logistic regression adjusting for histology (squamous Vs non-squamous), with 95% CI calculated by profile likelihood.|Durvalumab + Tremelimumab Vs Durvalumab Monotherapy||1.496|0.601|0.820
72593345|NCT02453282|144718489|SUPERIORITY||Odds Ratio (OR)|0.69||||0.05|TWO_SIDED|95.0|0.48|1.0||P-value is based on twice the change in log-likelihood resulting from the addition of a treatment factor to the model.|Regression, Logistic||The analysis was performed using logistic regression adjusting for histology (squamous Vs non squamous) and PD-L1 status (\>=25% Vs \<25%), with 95% CI calculated by profile likelihood.|Durvalumab Monotherapy Vs SoC Chemotherapy||1.000|0.480|0.050
72593346|NCT02453282|144718489|SUPERIORITY||Odds Ratio (OR)|0.67||||0.029|TWO_SIDED|95.0|0.464|0.959||P-value is based on twice the change in log-likelihood resulting from the addition of a treatment factor to the model.|Regression, Logistic||The analysis was performed using logistic regression adjusting for histology (squamous Vs non squamous) and PD-L1 status (\>=25% Vs \<25%), with 95% CI calculated by profile likelihood.|Durvalumab + Tremelimumab Vs SoC Chemotherapy||0.959|0.464|0.029
72414845|NCT02479412|144339923|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3435|STANDARD_ERROR_OF_MEAN|0.189||0.0723|TWO_SIDED|95.0|-0.7189|0.03179|||Mixed Models Analysis|||AZD7594 58 μg vs. PBO||0.03179|-0.7189|0.0723
72593347|NCT02453282|144718489|SUPERIORITY||Odds Ratio (OR)|0.97||||0.887|TWO_SIDED|95.0|0.661|1.43||P-value is based on twice the change in log-likelihood resulting from the addition of a treatment factor to the model.|Regression, Logistic||The analysis was performed using logistic regression adjusting for histology (squamous Vs non squamous) and PD-L1 status (\>=25% Vs \<25%), with 95% CI calculated by profile likelihood.|Durvalumab + Tremelimumab Vs Durvalumab Monotherapy||1.430|0.661|0.887
72593348|NCT02453282|144718490|SUPERIORITY||Odds Ratio (OR)|0.65||||0.012|TWO_SIDED|95.0|0.462|0.908||P-value is based on twice the change in log-likelihood resulting from the addition of a treatment factor to the model.|Regression, Logistic||The analysis was performed using logistic regression adjusting for histology (squamous Vs non squamous) and PD-L1 status (\>=25% Vs \<25%), with 95% CI calculated by profile likelihood.|Durvalumab Monotherapy Vs SoC Chemotherapy||0.908|0.462|0.012
72593349|NCT02453282|144718490|SUPERIORITY||Odds Ratio (OR)|0.76||||0.093|TWO_SIDED|95.0|0.543|1.048||P-value is based on twice the change in log-likelihood resulting from the addition of a treatment factor to the model.|Regression, Logistic||The analysis was performed using logistic regression adjusting for histology (squamous Vs non-squamous) and PD-L1 status (\>=25% Vs \<25%), with 95% CI calculated by profile likelihood.|Durvalumab + Tremelimumab Vs SoC Chemotherapy||1.048|0.543|0.093
72414846|NCT02479412|144339923|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4852|STANDARD_ERROR_OF_MEAN|0.1903||0.0124|TWO_SIDED|95.0|-0.8631|-0.1073|||Mixed Models Analysis|||AZD7594 250 μg vs. PBO||-0.1073|-0.8631|0.0124
72593350|NCT02453282|144718490|SUPERIORITY||Odds Ratio (OR)|1.16||||0.406|TWO_SIDED|95.0|0.818|1.647||P-value is based on twice the change in log-likelihood resulting from the addition of a treatment factor to the model.|Regression, Logistic||The analysis was performed using logistic regression adjusting for histology (squamous Vs non-squamous) and PD-L1 status (\>=25% Vs \<25%), with 95% CI calculated by profile likelihood.|Durvalumab + Tremelimumab Vs Durvalumab Monotherapy||1.647|0.818|0.406
72593351|NCT02453282|144718497|SUPERIORITY||Hazard Ratio (HR)|0.76||||0.03|TWO_SIDED|95.0|0.597|0.975||The 2-sided p-value was calculated using a stratified log-rank test adjusting for histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Log Rank||The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Durvalumab Monotherapy Vs SoC Chemotherapy||0.975|0.597|0.030
72414847|NCT02479412|144339923|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8026|STANDARD_ERROR_OF_MEAN|0.1914|<|0.0001|TWO_SIDED|95.0|-1.183|-0.4224|||Mixed Models Analysis|||AZD7594 800 μg vs. PBO||-0.4224|-1.183|<0.0001
72414848|NCT02479412|144339924|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3071|STANDARD_ERROR_OF_MEAN|0.1051||0.0044|TWO_SIDED|95.0|-0.5159|-0.09836|||Mixed Models Analysis|||AZD7594 58 μg vs. PBO||-0.09836|-0.5159|0.0044
72414849|NCT02479412|144339924|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1824|STANDARD_ERROR_OF_MEAN|0.1059||0.0883|TWO_SIDED|95.0|-0.3927|0.02789|||Mixed Models Analysis|||AZD7594 250 μg vs. PBO||0.02789|-0.3927|0.0883
72414850|NCT02479412|144339924|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4301|STANDARD_ERROR_OF_MEAN|0.1055|<|0.0001|TWO_SIDED|95.0|-0.6397|-0.2205|||Mixed Models Analysis|||AZD7594 800 μg vs. PBO||-0.2205|-0.6397|<0.0001
72593352|NCT02453282|144718497|SUPERIORITY||Hazard Ratio (HR)|0.78||||0.045|TWO_SIDED|95.0|0.606|0.994||The 2-sided p-value was calculated using a stratified log-rank test adjusting for histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Log Rank||The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Durvalumab + Tremelimumab Vs SoC Chemotherapy||0.994|0.606|0.045
72593353|NCT02453282|144718498|SUPERIORITY||Hazard Ratio (HR)|0.9||||0.255|TWO_SIDED|95.0|0.746|1.08||The 2-sided p-value was calculated using a stratified log-rank test adjusting for PD-L1 status (\>=25% Vs \<25%) and histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Log Rank||The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for PD-L1 status (\>=25% Vs \<25%) and histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Durvalumab Monotherapy Vs SoC Chemotherapy||1.080|0.746|0.255
72593354|NCT02453282|144718498|SUPERIORITY||Hazard Ratio (HR)|0.94||||0.534|TWO_SIDED|95.0|0.787|1.132||The 2-sided p-value was calculated using a stratified log-rank test adjusting for PD-L1 status (\>=25% Vs \<25%) and histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Log Rank||The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for PD-L1 status (\>=25% Vs \<25%) and histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Durvalumab + Tremelimumab Vs SoC Chemotherapy||1.132|0.787|0.534
72593355|NCT02453282|144718499|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.663|TWO_SIDED|95.0|0.824|1.131||The 2-sided p-value was calculated using a stratified log-rank test adjusting for PD-L1 status (\>=25% Vs \<25%) and histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Log Rank||The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for PD-L1 status (\>=25% Vs \<25%) and histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Durvalumab Monotherapy Vs SoC Chemotherapy||1.131|0.824|0.663
72593356|NCT02453282|144718499|SUPERIORITY||Hazard Ratio (HR)|0.88||||0.103|TWO_SIDED|95.0|0.746|1.027||The 2-sided p-value was calculated using a stratified log-rank test adjusting for PD-L1 status (\>=25% Vs \<25%) and histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Log Rank||The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for PD-L1 status (\>=25% Vs \<25%) and histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Durvalumab + Tremelimumab Vs SoC Chemotherapy||1.027|0.746|0.103
72593357|NCT01661933|144718509|SUPERIORITY_OR_OTHER|||||||0.693|TWO_SIDED||||||t-test, 2 sided|||||||0.693
72593358|NCT01661933|144718510|SUPERIORITY_OR_OTHER||||||=|0.837|TWO_SIDED||||||t-test, 2 sided|||||||=0.837
72593359|NCT01661933|144718511|SUPERIORITY_OR_OTHER||||||=|0.99|ONE_SIDED||||||Binomial distribution|||The null hypothesis was that irrespective of hookworm infection, GC-1g would result in a 2-point or more deterioration in the Marsh score. A binomial (yes=deterioration or no=no deterioration) distribution was applied to pre- and post-GC-1g paired biopsies.||||=0.99
72593360|NCT01661933|144718512|SUPERIORITY_OR_OTHER||||||=|0.005|TWO_SIDED||||||Mixed effects model.|||||||=0.005
72593361|NCT02901275|144718548|SUPERIORITY|||||||0.61||||||No covariate or correction for multiple comparisons. a priori statistical threshold is p\<.05|Mixed Models Analysis|||||||0.61
72593362|NCT02901275|144718549|SUPERIORITY||||||<|0.0001||||||No covariates or correction for multiple comparisons. a priori threshold is p\<.05.|Mixed Models Analysis|||||||<.0001
72593363|NCT02901275|144718550|SUPERIORITY|||||||0.51||||||No covariate or correction for multiple comparisons. a priori threshold for significance is p\<.05|Mixed Models Analysis|||||||0.51
72593364|NCT02063178|144718551|SUPERIORITY||Mean Difference (Final Values)|2.1|||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||This randomized clinical trial was designed to have 90% power to detect a 4% weight loss percent difference at 12 months between the two study arms.||||<0.001
72593365|NCT02063178|144718552|OTHER|Correlation|||||<|0.0001|||||||Correlation|||The association between weight change percent and attendance was described using Spearman rank correlation.||||<0.0001
72414851|NCT02479412|144339925|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1651|STANDARD_ERROR_OF_MEAN|0.09139||0.0741|TWO_SIDED|95.0|-0.3466|0.01638|||Mixed Models Analysis|||AZD7594 58 μg vs. PBO||0.01638|-0.3466|0.0741
72593366|NCT02063178|144718553|OTHER||||||<|0.0001|||||||Correlation|||||||<0.0001
72593367|NCT02063178|144718554|OTHER||||||<|0.0001|||||||Correlation|||||||<0.0001
72593368|NCT01892085|144718563|SUPERIORITY|||||||0.015|||||||Marginalized two part model|||||||0.015
72593369|NCT01892085|144718563|SUPERIORITY|||||||0.339|||||||Marginalized two part model|||||||0.339
72593370|NCT01892085|144718564|SUPERIORITY|||||||0.024|||||||Marginalized two part model|||||||0.024
72593371|NCT01892085|144718564|SUPERIORITY|||||||0.317|||||||Marginalized two part model|||||||0.317
72593372|NCT01892085|144718565|SUPERIORITY|||||||0.031|||||||Marginalized two part model|||||||0.031
72593373|NCT01892085|144718565|SUPERIORITY|||||||0.298|||||||Marginalized two part model|||||||0.298
72593374|NCT01892085|144718566|SUPERIORITY|||||||0.05|||||||Marginalized two part model|||||||0.05
72593375|NCT01892085|144718566|SUPERIORITY|||||||0.27|||||||Marginalized 2 part model|||||||0.27
72593376|NCT01892085|144718567|SUPERIORITY|||||||0.069|||||||Marginalized two part model|||||||0.069
72593377|NCT01892085|144718567|SUPERIORITY|||||||0.244|||||||Marginalized two part model|||||||0.244
72593378|NCT01892085|144718568|SUPERIORITY|||||||0.094|||||||Marginalized two part model|||||||0.094
72593379|NCT01892085|144718568|SUPERIORITY|||||||0.235|||||||Marginalized 2 part model|||||||0.235
72593380|NCT01892085|144718569|SUPERIORITY|||||||0.123|||||||Marginalized two part model|||||||0.123
72593381|NCT01892085|144718569|SUPERIORITY|||||||0.21|||||||Marginalized two part model|||||||0.210
72414852|NCT02479412|144339925|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.09079|STANDARD_ERROR_OF_MEAN|0.09204||0.3265|TWO_SIDED|95.0|-0.2736|0.09201|||Mixed Models Analysis|||AZD7594 250 μg vs. PBO||0.09201|-0.2736|0.3265
72414853|NCT02479412|144339925|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2532|STANDARD_ERROR_OF_MEAN|0.09176||0.007|TWO_SIDED|95.0|-0.4354|-0.07092|||Mixed Models Analysis|||AZD7594 800 μg vs. PBO||-0.07092|-0.4354|0.0070
72593382|NCT01892085|144718570|SUPERIORITY|||||||0.143|||||||Marginalized two part model|||||||0.143
72593383|NCT01892085|144718570|SUPERIORITY|||||||0.196|||||||Marginalized two part model|||||||0.196
72593384|NCT01892085|144718571|SUPERIORITY|||||||0.185|||||||Marginalized two part model|||||||0.185
72414854|NCT02479412|144339926|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4185|STANDARD_ERROR_OF_MEAN|0.1626||0.0116|TWO_SIDED|95.0|-0.7414|-0.09563|||Mixed Models Analysis|||AZD7594 58 μg vs. PBO||-0.09563|-0.7414|0.0116
72593385|NCT01892085|144718571|SUPERIORITY|||||||0.183|||||||Marginalized two part model|||||||0.183
72593386|NCT01892085|144718572|SUPERIORITY|||||||0.229|||||||Marginalized two part model|||||||0.229
72593387|NCT01892085|144718572|SUPERIORITY|||||||0.17|||||||Marginalized two part model|||||||0.170
72593388|NCT01892085|144718573|SUPERIORITY|||||||0.314|||||||Marginalized two part model|||||||0.314
72593389|NCT01892085|144718573|SUPERIORITY|||||||0.162|||||||Marginalized two part model|||||||0.162
72593390|NCT01892085|144718574|SUPERIORITY|||||||0.377|||||||Marginalized two part model|||||||0.377
72593391|NCT01892085|144718574|SUPERIORITY|||||||0.149|||||||Marginalized two part model|||||||0.149
72593392|NCT01892085|144718575|SUPERIORITY|||||||0.08|||||||ANOVA|||||||0.08
72593393|NCT01892085|144718576|SUPERIORITY|||||||0.82|||||||ANOVA|||||||0.82
72593394|NCT01892085|144718577|SUPERIORITY|||||||0.22|||||||Chi-squared|||||||00.22
72593395|NCT01892085|144718578|SUPERIORITY|||||||0.87|||||||Chi-squared|||||||0.87
72593396|NCT01892085|144718579|SUPERIORITY|||||||0.27|||||||Chi-squared|||||||0.27
72593397|NCT01892085|144718580|SUPERIORITY|||||||0.77|||||||Chi-squared|||||||0.77
72593398|NCT01892085|144718581|SUPERIORITY|||||||0.31|||||||Chi-squared|||||||0.31
72593399|NCT01892085|144718582|SUPERIORITY|||||||0.9|||||||Chi-squared|||||||0.90
72593400|NCT01892085|144718583|SUPERIORITY|||||||0.36|||||||Chi-squared|||||||0.36
72593401|NCT01629823|144718584|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.81||||0.51|TWO_SIDED|95.0|0.44|1.5||Comparison of 5cm group to control. No adjustment for multiple comparisons.|Regression, Linear|||Both the 5 and 10cm groups were compared to the control group, \<1cm H₂O||1.50|0.44|0.51
72593402|NCT01629823|144718584|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.84||||0.57|TWO_SIDED|95.0|0.47|1.52|||Regression, Linear|||||1.52|0.47|0.57
72593403|NCT01683422|144718602|SUPERIORITY|The reported p-value was calculated, and is not attempting to indicate the threshold for statistical significance.||||||0.1|||||||t-test, 1 sided|||In the RTOG 9812 (NCT00003591) for unresectable pancreatic cancer, a one-year survival rate of 43% was observed. There were 109 analyzable patients on NCT00003591 with 61 still at risk for death at one year. Using the method of Dixon and Simon, a sample size of 39 analyzable patients followed over 12 months will ensure at least 90% probability of detecting a minimum of 17% improvement in the one-year survival rate compared to NCT00003591 at the 0.10 significance level (with a one-sided test).||||0.1
72593404|NCT01393132|144718604|SUPERIORITY_OR_OTHER|||||||0.0108|TWO_SIDED||||||t-test, 2 sided|||Comparison of fluorescein staining score between the placebo and Thymosin beta 4 groups||||0.0108
72593405|NCT01393132|144718605|SUPERIORITY_OR_OTHER|||||||0.0141|TWO_SIDED||||||t-test, 2 sided|||Comparison of Ocular Discomfort Index score between the placebo and Thymosin beta 4 groups||||0.0141
72593406|NCT01393132|144718606|SUPERIORITY_OR_OTHER|||||||0.0162|TWO_SIDED||||||t-test, 2 sided|||Comparison of Tear Film Break up Time between the placebo and Thymosin beta 4 groups.||||0.0162
72593407|NCT02003963|144718608|SUPERIORITY|||||||0.05|||||||ANCOVA|||||||0.05
72593408|NCT03589326|144718618|SUPERIORITY||Risk Difference (RD)|0.18|||=|0.0021|TWO_SIDED|95.0|0.06|0.29||P-value is based on CMH chi-square test, with stratification according to randomization strata (age): 18 through \<45 years, ≥45 through \<60 years, and ≥60 years.|Chi-squared||Risk difference and 95% CI: adjusted percent ponatinib - adjusted percent imatinib and its 95% CI.|||0.29|0.06|=0.0021
72593409|NCT02847182|144718634|SUPERIORITY||Mean Difference (Final Values)|1.14||||0.83|TWO_SIDED|95.0|-1.58|3.86|||t-test, 2 sided|||Null hypothesis: The mean of the 6-month change in VABS-II Socialization Subscale Standard Score is the same for the Cord Blood and Placebo groups.||3.86|-1.58|0.83
72593410|NCT04216589|144718685|OTHER|This was a single arm trial.|Mean Difference (Net)|-4.24|STANDARD_DEVIATION|4.05|<|0.001|TWO_SIDED|95.0|-5.41|-3.06|||Regression, Linear|||The study was powered to detect an absolute IHTG change of -5% assuming a null change of 0%, a standard deviation of absolute IHTG change of 9%, and 37 evaluable participants.||-3.06|-5.41|<0.001
72593411|NCT04216589|144718686|OTHER|This was a single arm trial.|Mean Difference (Net)|-31.33|STANDARD_DEVIATION|26.5|<|0.001|TWO_SIDED|95.0|-39.04|-23.62||No adjustment for multiple comparisons|Regression, Linear|||||-23.62|-39.04|<0.001
72593412|NCT04216589|144718690|OTHER|This was a single arm trial.|Mean Difference (Net)|-2.77|STANDARD_DEVIATION|2.05|<|0.001|TWO_SIDED|95.0|-3.36|-2.17||Not adjusted for multiple comparisons.|Regression, Linear|||||-2.17|-3.36|<0.001
72593413|NCT04216589|144718691|OTHER|This was a single arm trial.|Mean Difference (Net)|-2.15|STANDARD_DEVIATION|1.38|<|0.001|TWO_SIDED|95.0|-2.55|-1.75||Not adjusted for multiple comparisons|Regression, Linear|||||-1.75|-2.55|<0.001
72593414|NCT04216589|144718692|OTHER|This was a single arm trial.|Mean Difference (Net)|-7.8|STANDARD_DEVIATION|5.77|<|0.001|TWO_SIDED|95.0|-9.48|-6.13||Not adjusted for multiple comparisons|Regression, Linear|||||-6.13|-9.48|<0.001
72593415|NCT04216589|144718693|OTHER|This was a single arm trial.|Mean Difference (Net)|-6.16|STANDARD_DEVIATION|3.96|<|0.001|TWO_SIDED|95.0|-7.3|-5.03||Not adjusted for multiple comparisons|Regression, Linear|||||-5.03|-7.30|<0.001
72593416|NCT04216589|144718694|OTHER|This was a single arm trial.|Mean Difference (Net)|-6.66|STANDARD_DEVIATION|6.47|<|0.001|TWO_SIDED|95.0|-8.54|-4.78||Not adjusted for multiple comparisons|Regression, Linear|||||-4.78|-8.54|<0.001
72593417|NCT04216589|144718695|OTHER|This was a single arm trial.|Mean Difference (Net)|-5.53|STANDARD_DEVIATION|5.3|<|0.001|TWO_SIDED|95.0|-7.07|-3.99||Not adjusted for multiple comparisons|Regression, Linear|||||-3.99|-7.07|<0.001
72593418|NCT04216589|144718696|OTHER|This was a single arm trial.|Mean Difference (Net)|-1.46|STANDARD_DEVIATION|5.82||0.092|TWO_SIDED|95.0|-3.17|0.25||Not adjusted for multiple comparisons|Regression, Linear|||||0.25|-3.17|0.092
72593419|NCT04216589|144718698|OTHER|This was a single arm trial.|Mean Difference (Net)|-0.25|STANDARD_DEVIATION|0.259|<|0.001|TWO_SIDED|95.0|-0.32|-0.17||Not adjusted for multiple comparisons|Regression, Linear|||||-0.17|-0.32|< 0.001
72593420|NCT04216589|144718699|OTHER|This was a single arm trial.|Mean Difference (Net)|-9.9|STANDARD_DEVIATION|16.6|<|0.001|TWO_SIDED|95.0|-14.7|-5.09||Not adjusted for multiple comparisons|Regression, Linear|||||-5.09|-14.70|<0.001
72593421|NCT04216589|144718700|OTHER|This was a single arm trial.|Mean Difference (Net)|-8.87|STANDARD_DEVIATION|11.5|<|0.001|TWO_SIDED|95.0|-12.26|-5.48||Not adjusted for multiple comparisons|Regression, Linear|||||-5.48|-12.26|<0.001
72414855|NCT02479412|144339926|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1794|STANDARD_ERROR_OF_MEAN|0.1628||0.2732|TWO_SIDED|95.0|-0.5027|0.1438|||Mixed Models Analysis|||AZD7594 250 μg vs. PBO||0.1438|-0.5027|0.2732
72593422|NCT04216589|144718701|OTHER|This was a single arm trial.|Mean Difference (Net)|-3.98|STANDARD_DEVIATION|23.1||0.25|TWO_SIDED|95.0|-10.84|2.89||Not adjusted for multiple comparisons|Regression, Linear|||||2.89|-10.84|0.25
72593423|NCT04216589|144718702|OTHER|This was a single arm trial.|Mean Difference (Net)|-11.93|STANDARD_DEVIATION|26.4||0.004|TWO_SIDED|95.0|-19.79|-4.08||Not adjusted for multiple comparisons|Regression, Linear|||||-4.08|-19.79|0.004
72414856|NCT02479412|144339926|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7661|STANDARD_ERROR_OF_MEAN|0.1636|<|0.0001|TWO_SIDED|95.0|-1.091|-0.4411|||Mixed Models Analysis|||AZD7594 800 μg vs. PBO||-0.4411|-1.091|<0.0001
72593424|NCT04216589|144718703|OTHER|This was a single arm trial.|Mean Difference (Net)|-1.04|STANDARD_DEVIATION|20.5||0.73|TWO_SIDED|95.0|-7.14|5.05||Not adjusted for multiple comparisons|Regression, Linear|||||5.05|-7.14|0.73
72593425|NCT04216589|144718704|OTHER|This was a single arm trial.|Mean Difference (Net)|-6.91|STANDARD_DEVIATION|23.1||0.051|TWO_SIDED|95.0|-13.85|0.03||Not adjusted for multiple comparisons|Regression, Linear|||||0.03|-13.85|0.051
72593426|NCT04216589|144718705|OTHER|This was a single arm trial.|Mean Difference (Net)|2.04|STANDARD_DEVIATION|6.96||0.053|TWO_SIDED|95.0|-0.02|4.11||Not adjusted for multiple comparisons|Regression, Linear|||||4.11|-0.02|0.053
72414857|NCT02479412|144339927|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1067|STANDARD_ERROR_OF_MEAN|0.04982||0.0349|TWO_SIDED|95.0|-0.2057|-0.007755|||Mixed Models Analysis|||AZD7594 58 μg vs. PBO||-0.007755|-0.2057|0.0349
72414858|NCT02479412|144339927|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.08205|STANDARD_ERROR_OF_MEAN|0.05015||0.1052|TWO_SIDED|95.0|-0.1817|0.01756|||Mixed Models Analysis|||AZD7594 250 μg vs. PBO||0.01756|-0.1817|0.1052
72414859|NCT02479412|144339927|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2027|STANDARD_ERROR_OF_MEAN|0.05044||0.0001|TWO_SIDED|95.0|-0.3028|-0.1025|||Mixed Models Analysis|||AZD7594 800 μg vs. PBO||-0.1025|-0.3028|0.0001
72593427|NCT04216589|144718706|OTHER|This was a single arm trial.|Mean Difference (Net)|-0.78|STANDARD_DEVIATION|6.66||0.43|TWO_SIDED|95.0|-2.76|1.2||Not adjusted for multiple comparisons|Regression, Linear|||||1.20|-2.76|0.43
72593428|NCT04216589|144718707|OTHER|This was a single arm trial.|Mean Difference (Net)|-26.78|STANDARD_DEVIATION|64.8||0.007|TWO_SIDED|95.0|-46.04|-7.53||Not adjusted for multiple comparisons|Regression, Linear|||||-7.53|-46.04|0.007
72593429|NCT04216589|144718708|OTHER|This was a single arm trial.|Mean Difference (Net)|-18.65|STANDARD_DEVIATION|49.3||0.014|TWO_SIDED|95.0|-33.29|-4.01||Not adjusted for multiple comparisons|Regression, Linear|||||-4.01|-33.29|0.014
72593430|NCT04216589|144718709|OTHER|This was a single arm trial.|Risk Ratio (RR)|0.72||||0.016|TWO_SIDED|95.0|0.55|0.94||Not adjusted for multiple comparisons.|GEE model for repeated binary outcomes|The GEE model used a log link and an unstructured correlation.|The risk ratio is comparing the estimated risk at Week 12 (0.55; 95% CI: 0.43, 0.72) to estimated risk at Baseline (0.77; 95% CI: 0.67, 0.90).|Comparison between Baseline and Week 12.||0.94|0.55|0.016
72593431|NCT04216589|144718709|OTHER|This was a single arm trial.|Risk Ratio (RR)|0.75||||0.033|TWO_SIDED|95.0|0.58|0.98||Not adjusted for multiple comparisons.|GEE model for repeated binary outcomes|The GEE model used a log link and an unstructured correlation.|The risk ratio is comparing the estimated risk at Week 24 (0.58; 95% CI: 0.46, 0.74) to estimated risk at Baseline (0.77; 95% CI: 0.67, 0.90).|Comparison between Baseline and Week 24.||0.98|0.58|0.033
72593432|NCT02326298|144718712|SUPERIORITY||Odds Ratio (OR)|28.962|||<|0.0001|TWO_SIDED|97.5|6.968|120.371||The p-value for the primary analysis was evaluated at a 2-sided significance level of 0.025 for each CZP dose versus (vs) PBO.|Regression, Logistic|Estimated responder rate, odds ratios, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.||The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||120.371|6.968|<0.0001
72593433|NCT02326298|144718712|SUPERIORITY||Odds Ratio (OR)|45.66|||<|0.0001|TWO_SIDED|97.5|10.657|195.634||The p-value for the primary analysis was evaluated at a 2-sided significance level of 0.025 for each CZP dose vs PBO.|Regression, Logistic|Estimated responder rate, odds ratios, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.||The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||195.634|10.657|<0.0001
72593434|NCT02326298|144718712|SUPERIORITY||Estimated difference in responder rate|60.0|||||TWO_SIDED|95.0|47.92|72.17|||Regression, Logistic|Estimated responder rate, odds ratios, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.|Estimate and 95% CI for difference in proportion of responders for CZP 200 mg Q2W (RS) versus Placebo Q2W (RS).|The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||72.17|47.92|
72593435|NCT02326298|144718712|SUPERIORITY||Estimated difference in responder rate|69.3|||||TWO_SIDED|95.0|57.65|80.99|||Regression, Logistic|Estimated responder rate, odds ratios, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.|Estimate and 95% CI for difference in proportion of responders for CZP 400 mg Q2W (RS) versus Placebo Q2W (RS).|The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||80.99|57.65|
72593436|NCT02326298|144718713|SUPERIORITY||Odds Ratio (OR)|20.116|||<|0.0001|TWO_SIDED|97.5|3.699|109.399||The p-value for the primary analysis was evaluated at a 2-sided significance level of 0.025 for each CZP dose vs PBO.|Regression, Logistic|Estimated responder rate, odds ratios, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.||The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||109.399|3.699|<0.0001
72593437|NCT02326298|144718713|SUPERIORITY||Odds Ratio (OR)|31.143|||<|0.0001|TWO_SIDED|97.5|5.687|170.548||The p-value for the primary analysis was evaluated at a 2-sided significance level of 0.025 for each CZP dose vs PBO.|Regression, Logistic|Estimated responder rate, odds ratios, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.||The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||170.548|5.687|<0.0001
72593438|NCT02326298|144718713|SUPERIORITY||Estimated difference in responder rate|42.8|||||TWO_SIDED|95.0|30.7|54.86|||Regression, Logistic|Estimated responder rate, odds ratios, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.|Estimate and 95% CI for difference in proportion of responders for CZP 200 mg Q2W (RS) versus Placebo Q2W (RS).|The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||54.86|30.70|
72593439|NCT02326298|144718713|SUPERIORITY||Estimated difference in responder rate|53.6|||||TWO_SIDED|95.0|41.33|65.94|||Regression, Logistic|Estimated responder rate, odds ratios, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.|Estimate and 95% CI for difference in proportion of responders for CZP 400 mg Q2W (RS) versus Placebo Q2W (RS).|The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||65.94|41.33|
72593440|NCT02326298|144718714|SUPERIORITY||Odds Ratio (OR)|36.668|||<|0.0001|TWO_SIDED|97.5|5.717|235.193||The p-value for this analysis as used in the fixed sequence testing procedure was evaluated at a 2-sided significance level of 0.025 for each CZP dose vs PBO.|Regression, Logistic|Estimated responder rate, odds ratios, CIs, p-values based on a logistic regression model with factors for treatment,region, prior biologic exposure.||The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||235.193|5.717|<0.0001
72593441|NCT02326298|144718714|SUPERIORITY||Odds Ratio (OR)|50.606|||<|0.0001|TWO_SIDED|97.5|7.88|324.988||The p-value for this analysis as used in the fixed sequence testing procedure was evaluated at a 2-sided significance level of 0.025 for each CZP dose vs PBO.|Regression, Logistic|Estimated responder rate, odds ratios, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.||The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||324.988|7.880|<0.0001
72593442|NCT02326298|144718714|SUPERIORITY||Estimated difference in responder rate|35.4|||||TWO_SIDED|95.0|20.85|49.87|||Regression, Logistic|Estimated responder rate, odds ratios, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.|Estimate and 95% CI for difference in proportion of responders for CZP 200 mg Q2W (RS) versus Placebo Q2W (RS).|The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||49.87|20.85|
72593443|NCT02326298|144718714|SUPERIORITY||Estimated difference in responder rate|43.1|||||TWO_SIDED|95.0|27.56|58.71|||Regression, Logistic|Estimated responder rate, odds ratios, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.|Estimate and 95% CI for difference in proportion of responders for CZP 400 mg Q2W (RS) versus Placebo Q2W (RS).|The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||58.71|27.56|
72593444|NCT02326298|144718715|SUPERIORITY||Adjusted Mean Treatment Differences|-6.0|||<|0.0001|TWO_SIDED|97.5|-8.18|-3.81||P-value obtained for each treatment group comparison tested at a significance level of 0.025 in the fixed sequence testing procedure.|ANCOVA|ANCOVA model of change from Baseline DLQI score with treatment group, region, prior biologic exposure as factors; Baseline DLQI score as a covariate.||The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||-3.81|-8.18|<0.0001
72593445|NCT02326298|144718715|SUPERIORITY||Ajusted Mean Treatment Differences|-6.84|||<|0.0001|TWO_SIDED|97.5|-9.05|-4.62||P-value obtained for each treatment group comparison tested at a significance level of 0.025 in the fixed sequence testing procedure.|ANCOVA|ANCOVA model of change from Baseline DLQI score with treatment group, region, prior biologic exposure as factors; Baseline DLQI score as a covariate.||The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||-4.62|-9.05|<0.0001
72593446|NCT03521817|144718720|OTHER||Mean Difference (Net)|-0.18|STANDARD_ERROR_OF_MEAN|0.14|<|0.231|TWO_SIDED||||||t-test, 2 sided|||||||<0.231
72593447|NCT01632904|144718735|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.82||||0.139|TWO_SIDED|95.0|0.82|4.04|||Chi-squared|||||4.04|0.82|0.139
72593448|NCT01196936|144718746|SUPERIORITY|||||||0.05||||||The calculated p-value is 0.05.|Mixed Models Analysis|||||||0.05
72593449|NCT01196936|144718747|SUPERIORITY|||||||0.0266|||||||Mixed Models Analysis|||||||0.0266
72593450|NCT01196936|144718748|SUPERIORITY|||||||0.12|||||||Fisher Exact|||||||0.12
72593451|NCT01196936|144718749|SUPERIORITY||||||>|0.05|||||||Mixed Models Analysis|||||||>0.05
72593452|NCT01196936|144718750|SUPERIORITY|||||||0.78|||||||Wilcoxon (Mann-Whitney)|||||||0.78
72593453|NCT01196936|144718751|SUPERIORITY||||||>|0.05|||||||Chi-squared|||||||> 0.05
72593454|NCT01196936|144718752|SUPERIORITY|||||||0.071|||||||Mixed Models Analysis|||||||0.071
72593455|NCT01196936|144718753|SUPERIORITY|||||||0.739|||||||Mixed Models Analysis|||||||0.739
72593456|NCT01196936|144718754|SUPERIORITY|||||||0.8315|||||||Mixed Models Analysis|||||||0.8315
72593457|NCT03315455|144718787|SUPERIORITY||ABR Ratio|0.04|||<|0.0001|TWO_SIDED|95.0|0.016|0.084||Statistical significance was controlled at a 2-sided alpha level of 0.05. Hierarchical testing was used to account for multiple comparisons.|Stratified Wald test||The ABR ratio was calculated as Arm A vs. Arm C.|H0 (null hypothesis): ABR Ratio = 1; versus, H1 (alternative hypothesis): ABR Ratio ≠ 1||0.084|0.016|<0.0001
72593458|NCT03315455|144718787|SUPERIORITY||ABR Ratio|0.04|||<|0.0001|TWO_SIDED|95.0|0.015|0.082||Statistical significance was controlled at a 2-sided alpha level of 0.05. Hierarchical testing was used to account for multiple comparisons.|Stratified Wald test||The ABR ratio was calculated as Arm B vs. Arm C.|H0 (null hypothesis): ABR Ratio = 1; versus, H1 (alternative hypothesis): ABR Ratio ≠ 1||0.082|0.015|<0.0001
72593459|NCT03315455|144718790|SUPERIORITY||ABR Ratio|0.05|||<|0.0001|TWO_SIDED|95.0|0.026|0.084||Statistical significance was controlled at a 2-sided alpha level of 0.05. Hierarchical testing was used to account for multiple comparisons.|Stratified Wald test||The ABR ratio was calculated as Arm A vs. Arm C.|H0 (null hypothesis): ABR Ratio = 1; versus, H1 (alternative hypothesis): ABR Ratio ≠ 1||0.084|0.026|<0.0001
72593460|NCT03315455|144718790|SUPERIORITY||ABR Ratio|0.05|||<|0.0001|TWO_SIDED|95.0|0.028|0.092||Statistical significance was controlled at a 2-sided alpha level of 0.05. Hierarchical testing was used to account for multiple comparisons.|Stratified Wald test||The ABR ratio was calculated as Arm B vs. Arm C.|H0 (null hypothesis): ABR Ratio = 1; versus, H1 (alternative hypothesis): ABR Ratio ≠ 1||0.092|0.028|<0.0001
72593461|NCT03315455|144718793|SUPERIORITY||ABR Ratio|0.02|||<|0.0001|TWO_SIDED|95.0|0.006|0.053||Statistical significance was controlled at a 2-sided alpha level of 0.05. Hierarchical testing was used to account for multiple comparisons.|Stratified Wald test||The ABR ratio was calculated as Arm A vs. Arm C.|H0 (null hypothesis): ABR Ratio = 1; versus, H1 (alternative hypothesis): ABR Ratio ≠ 1||0.053|0.006|<0.0001
72593462|NCT03315455|144718793|SUPERIORITY||ABR Ratio|0.02|||<|0.0001|TWO_SIDED|95.0|0.007|0.059||Statistical significance was controlled at a 2-sided alpha level of 0.05. Hierarchical testing was used to account for multiple comparisons.|Stratified Wald test||The ABR ratio was calculated as Arm B vs. Arm C.|H0 (null hypothesis): ABR Ratio = 1; versus, H1 (alternative hypothesis): ABR Ratio ≠ 1||0.059|0.007|<0.0001
72593463|NCT03315455|144718796|SUPERIORITY||ABR Ratio|0.04|||<|0.0001|TWO_SIDED|95.0|0.017|0.102||Statistical significance was controlled at a 2-sided alpha level of 0.05. Hierarchical testing was used to account for multiple comparisons.|Stratified Wald test||The ABR ratio was calculated as Arm A vs. Arm C.|H0 (null hypothesis): ABR Ratio = 1; versus, H1 (alternative hypothesis): ABR Ratio ≠ 1||0.102|0.017|<0.0001
72414860|NCT02479412|144339928|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.673|STANDARD_ERROR_OF_MEAN|0.2946||0.0247|TWO_SIDED|95.0|0.08779|1.258|||Mixed Models Analysis|||AZD7594 58 μg vs. PBO||1.258|0.08779|0.0247
72593464|NCT03315455|144718796|SUPERIORITY||ABR Ratio|0.03|||<|0.0001|TWO_SIDED|95.0|0.013|0.084||Statistical significance was controlled at a 2-sided alpha level of 0.05. Hierarchical testing was used to account for multiple comparisons.|Stratified Wald test||The ABR ratio was calculated as Arm B vs. Arm C.|H0 (null hypothesis): ABR Ratio = 1; versus, H1 (alternative hypothesis): ABR Ratio ≠ 1||0.084|0.013|<0.0001
72593465|NCT03315455|144718799|SUPERIORITY||ABR Ratio|0.05|||<|0.0001|TWO_SIDED|95.0|0.016|0.163||Not controlled for Type I error|Stratified Wald test||The ABR ratio was calculated as Arm A vs. Arm C.|||0.163|0.016|<0.0001
72414861|NCT02479412|144339928|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.4281|STANDARD_ERROR_OF_MEAN|0.2965||0.1521|TWO_SIDED|95.0|-0.1607|1.017|||Mixed Models Analysis|||AZD7594 250 μg vs. PBO||1.017|-0.1607|0.1521
72414862|NCT02479412|144339928|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.9415|STANDARD_ERROR_OF_MEAN|0.2987||0.0022|TWO_SIDED|95.0|0.3483|1.535|||Mixed Models Analysis|||AZD7594 800 μg vs. PBO||1.535|0.3483|0.0022
72414863|NCT02479412|144339932|SUPERIORITY_OR_OTHER||Ratio Estimate (%)|272.2|||<|0.0001|TWO_SIDED|90.0|237.43|312.05|||ANOVA|||AZD7594 250 μg versus AZD7594 58 μg||312.05|237.43|<0.0001
72414864|NCT02479412|144339932|SUPERIORITY_OR_OTHER||Ratio Estimate (%)|676.13|||<|0.0001|TWO_SIDED|90.0|580.91|786.95|||ANOVA|||AZD7594 800 μg versus AZD7594 58 μg||786.95|580.91|<0.0001
72593466|NCT03315455|144718799|SUPERIORITY||ABR Ratio|0.04|||<|0.0001|TWO_SIDED|95.0|0.011|0.122||Not controlled for Type I error|ABR Ratio||The ABR ratio was calculated as Arm B vs. Arm C.|||0.122|0.011|<0.0001
72593467|NCT03315455|144718804|SUPERIORITY||Difference in Adjusted Means|14.68||||0.0515|TWO_SIDED|95.0|-0.1|29.46||Type I error controlled|ANCOVA|Means were adjusted for baseline score, treatment group, and treatment by baseline interaction term.|The difference in adjusted means was calculated as Arm C minus Arm A.|||29.46|-0.10|0.0515
72593468|NCT03315455|144718804|SUPERIORITY||Difference in Adjusted Means|18.33||||0.0204|TWO_SIDED|95.0|2.97|33.68||Type I error controlled|ANCOVA|Means were adjusted for baseline score, treatment group, and treatment by baseline interaction term.|The difference in adjusted means was calculated as Arm C minus Arm B.|||33.68|2.97|0.0204
72414865|NCT02479412|144339933|SUPERIORITY_OR_OTHER||Ratio Estimate (%)|337.82|||<|0.0001|TWO_SIDED|90.0|290.8|392.43|||ANOVA|||AZD7594 250 μg versus AZD7594 58 μg||392.43|290.80|<0.0001
72414866|NCT02479412|144339933|SUPERIORITY_OR_OTHER||Ratio Estimate (%)|964.62|||<|0.0001|TWO_SIDED|90.0|816.13|1140.13|||ANOVA|||AZD7594 800 μg versus AZD7594 58 μg||1140.13|816.13|<0.0001
72593469|NCT03315455|144718806|SUPERIORITY||Difference in Adjusted Means|6.06||||0.3281|TWO_SIDED|95.0|-6.27|18.4||Not controlled for Type I error|ANCOVA|Means were adjusted for baseline score, treatment group, and treatment by baseline interaction term.|The difference in adjusted means was calculated as Arm C minus Arm A.|||18.40|-6.27|0.3281
72593470|NCT03315455|144718806|SUPERIORITY||Difference in Adjusted Means|14.01||||0.0297|TWO_SIDED|95.0|1.44|26.59||Not controlled for Type I error|ANCOVA|Means were adjusted for baseline score, treatment group, and treatment by baseline interaction term.|The difference in adjusted means was calculated as Arm C minus Arm B.|||26.59|1.44|0.0297
72593471|NCT03315455|144718809|SUPERIORITY||Difference in Adjusted Means|-3.46||||0.6165|TWO_SIDED|95.0|-17.23|10.31||Not controlled for Type I error|ANCOVA|Means were adjusted for baseline score, treatment group, and treatment by baseline interaction term.|The difference in adjusted means was calculated as Arm C minus Arm A.|||10.31|-17.23|0.6165
72593472|NCT03315455|144718809|SUPERIORITY||Difference in Adjusted Means|-7.58||||0.2797|TWO_SIDED|95.0|-21.48|6.33||Not controlled for Type I error|ANCOVA|Means were adjusted for baseline score, treatment group, and treatment by baseline interaction term.|The difference in adjusted means was calculated as Arm C minus Arm B.|||6.33|-21.48|0.2797
72593473|NCT03315455|144718811|SUPERIORITY||Difference in Adjusted Means|-0.05||||0.489|TWO_SIDED|95.0|-0.18|0.09||Not controlled for Type I error|ANCOVA|Means were adjusted for baseline score, treatment group, and treatment by baseline interaction term.|The difference in adjusted means was calculated as Arm C minus Arm A.|||0.09|-0.18|0.4890
72593474|NCT03315455|144718811|SUPERIORITY||Difference in Adjusted Means|-0.08||||0.2454|TWO_SIDED|95.0|-0.22|0.06||Not controlled for Type I error|ANCOVA|Means were adjusted for baseline score, treatment group, and treatment by baseline interaction term.|The difference in adjusted means was calculated as Arm C minus Arm B.|||0.06|-0.22|0.2454
72593475|NCT03030118|144718837|SUPERIORITY|||||||0.72|||||||Regression, Logistic|||For the primary outcome (SLICC classification criteria count \[SLICC score\]), measured every 12 weeks over a 96-week period, we used an ordinal logistic regression model to compare the estimated slopes over time for the intervention (HCQ) and placebo groups. The model accounted for the ordinal and non-decreasing properties of the SLICC score. Our null hypothesis was that the intervention slope equaled the placebo slope, with a corresponding hypothesis that the slopes were not equal.||||0.72
72593476|NCT03030118|144718838|SUPERIORITY|||||||0.81|||||||Regression, Cox|||Progression to SLE was defined as the number of subjects in whom a SLICC score of 4 was recorded, up to 96 weeks.||||0.81
72593477|NCT03030118|144718839|SUPERIORITY|||||||0.74|||||||Regression, Logistic|||"For the SLEDAI score, we combined responses to model the following groups:~* Score of 0 or 1~* Score of 2 or 3~* Score of 4, 6, or 8"||||0.74
72593478|NCT03030118|144718840|SUPERIORITY|||||||0.77|||||||Regression, Logistic|Ordinal logistic regression||"For analysis, we combined responses ≥3 to model the following groups:~* Score of 0~* Score of 1~* Score of 2~* Score of 3 or higher"||||0.77
72593479|NCT03030118|144718841|SUPERIORITY|||||||0.386|||||||t-test, 2 sided|Paired t-test||||||0.386
72593480|NCT03030118|144718842|SUPERIORITY|||||||0.497|||||||t-test, 2 sided|Paired t-test||||||0.497
72593481|NCT03030118|144718843|SUPERIORITY|||||||0.99|||||||Regression, Logistic|Ordinal logistic regression||||||0.99
72421578|NCT01337986|144354298|SUPERIORITY_OR_OTHER_LEGACY|||||||0.11|||||||Mixed Models Analysis|||Null hypothesis for period effect: there will be no difference in the change relevant to baseline (visit 1) in EDTRS 5% contrast sensitivity for those who started on dalfampridine and crossed over to placebo, compared to those who started on placebo and crossed over to dalfampridine.||||0.11
72593482|NCT03030118|144718844|SUPERIORITY||||||>|0.05|||||||t-test, 2 sided|||||||>0.05
72593483|NCT03030118|144718845|NON_INFERIORITY|Outcome with hydroxychloroquine is hypothesized to be not inferior to outcome with placebo.|||||>|0.5|||||||Fisher Exact|||||||>0.5
72593484|NCT03030118|144718846|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.00
72593485|NCT03030118|144718847|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.00
72593486|NCT01911780|144718848|SUPERIORITY_OR_OTHER||Adjusted mean, comparison|-7.5|STANDARD_ERROR_OF_MEAN|1.1|<|0.0001|TWO_SIDED|95.0|-9.7|-5.3|||LOCF-ANCOVA|Last observation carried forward (LOCF) was used as the imputation method|Model includes baseline DBP as a linear covariate, and treatment and center as fixed effects.|||-5.3|-9.7|<0.0001
72593487|NCT01911780|144718849|SUPERIORITY_OR_OTHER||Adjusted mean, comparison|-8.6|STANDARD_ERROR_OF_MEAN|2.1|<|0.0001|TWO_SIDED|95.0|-12.7|-4.5||Additional information, the p-value is not adjusted for multiplicity.|LOCF-ANCOVA||Model includes baseline SBP as a linear covariate, and treatment and center as fixed effects.|||-4.5|-12.7|<0.0001
72593488|NCT01911780|144718850|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.1||||0.0052|TWO_SIDED|95.0|1.4|7.1||Additional information, the p-value is not adjusted for multiplicity.|Regression, Logistic|Non-completers considered failures (NCF) was used as the imputation method.|Exact 95 % confidence interval by Clopper and Pearson. Logistic regression includes treatment and center.|||7.1|1.4|0.0052
72414867|NCT01571362|144339941|SUPERIORITY_OR_OTHER||Difference of LS Means|-0.62|STANDARD_ERROR_OF_MEAN|0.246||0.0114|TWO_SIDED|95.0|-1.11|-0.14||No adjustment was made for multiple comparisons. Statistical significance was if unadjusted p was less than or equal to (\<=) 0.05.|ANCOVA|||Null Hypothesis: No treatment difference. Power was 90%, 2-sided Alpha of 0.05, with assumed difference of 1 point and assumed standard deviation of 2.4 points.||-0.14|-1.11|0.0114
72421579|NCT01337986|144354299|SUPERIORITY_OR_OTHER_LEGACY|||||||0.93|||||||Regression, Logistic|||||||0.93
72421580|NCT01337986|144354300|SUPERIORITY_OR_OTHER_LEGACY|||||||0.34|||||||Regression, Logistic|||||||.34
72414868|NCT01571362|144339942|SUPERIORITY_OR_OTHER||Difference of LS Means|0.18|STANDARD_ERROR_OF_MEAN|0.565||0.7547|TWO_SIDED|95.0|-0.94|1.29||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and Baseline score and final total daily dose of Titration Period as covariates.|ANCOVA|||||1.29|-0.94|0.7547
72593489|NCT01911780|144718852|SUPERIORITY_OR_OTHER||Adjusted Mean|-0.4|STANDARD_ERROR_OF_MEAN|1.4|||TWO_SIDED|95.0|-3.1|2.3|||mixed-effects model repeated measures||As a linear covariate, and treatment and visit, treatment by visit interaction and baseline value by visit interaction as fixed effects.|||2.3|-3.1|
72593490|NCT01911780|144718853|SUPERIORITY_OR_OTHER||Adjusted Mean|2.3|STANDARD_ERROR_OF_MEAN|1.9|||TWO_SIDED|95.0|-1.5|6.1|||mixed-effects model repeated measures||Model includes baseline SBP as a linear covariate, and treatment and visit, treatment by visit interaction and baseline value by visit interaction as fixed effects.|||6.1|-1.5|
72593491|NCT02720744|144718866|SUPERIORITY||Mean Difference (Net)|6.13|||<|0.001|TWO_SIDED|95.0|3.52|8.75||Each outcome measure for the 9.0 g, 7.5 g, and 6.0 g doses were tested at the 2-sided α level of 0.05.|Mixed Models Analysis|P-values were estimated using an MMRM with change from baseline (or its log transformation).|Difference from placebo was defined by the FT218 mean value minus placebo value.|||8.75|3.52|<0.001
72593492|NCT02720744|144718867|SUPERIORITY||Odds Ratio (OR)|5.56|||<|0.001|TWO_SIDED|95.0|2.76|11.23||Each outcome measure for the 9.0 g, 7.5 g, and 6.0 g doses were tested at the 2-sided α level of 0.05.|GLIMMIX model|P-values estimated with categorized CGI-Improvement response (very much or much improved versus other category) at the specific visit.||||11.23|2.76|<0.001
72593493|NCT02720744|144718868|SUPERIORITY||Mean Difference (Net)|-6.65|||<|0.001|TWO_SIDED|95.0|-9.32|-3.98||Each outcome measure for the 9.0 g, 7.5 g, and 6.0 g doses were tested at the 2-sided α level of 0.05.|Mixed Models Analysis|P-values were estimated using an MMRM with change from baseline to the end of the respective treatment period.||||-3.98|-9.32|<0.001
72593494|NCT00550862|144718883|OTHER||||||<|0.0001||||||Initial Phase 2 study: no a priori estimate of treatment effect available. Effect size estimated.|Wilcoxon (Mann-Whitney)|Hierarchical model applied and pairwise comparisons of the 10mg treatment group versus the placebo group, then 25 mg and 50 mg were performed.||All tests: Descriptive methods were used with nominal p values provided and 95% confidence intervals.||||<0.0001
72593495|NCT00550862|144718883|OTHER||||||<|0.0001||||||Initial Phase 2 study: no a priori estimate of treatment effect available. Effect size estimated.|Wilcoxon (Mann-Whitney)|Hierarchical model applied and pairwise comparisons of the 10mg treatment group versus the placebo group, then 25 mg and 50 mg were performed.||All tests: Descriptive methods were used with nominal p values provided and 95% confidence intervals.||||<0.0001
72593496|NCT00550862|144718883|OTHER||||||<|0.0001||||||Initial Phase 2 study: no a priori estimate of treatment effect available. Effect size estimated.|Wilcoxon (Mann-Whitney)|Hierarchical model applied and pairwise comparisons of the 10mg treatment group versus the placebo group, then 25 mg and 50 mg were performed.||All tests: Descriptive methods were used with nominal p values provided and 95% confidence intervals||||<0.0001
72593497|NCT00550862|144718884|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.0001
72593498|NCT00550862|144718885|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0005||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.0005
72593499|NCT00980174|144718920|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.8|||<|0.0001|TWO_SIDED|95.0|4.0|5.6|||ANCOVA|Adjusted by level of baseline bone mineral density T-score|Denosumab - Placebo|||5.6|4.0|<0.0001
72593500|NCT00980174|144718921|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.0|||<|0.0001|TWO_SIDED|95.0|1.5|2.6||p-value is adjusted for multiple comparisons by Hochberg method|ANCOVA|Adjusted by level of baseline bone mineral density T-score|Denosumab - Placebo|||2.6|1.5|<0.0001
72593501|NCT00980174|144718922|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.2|||<|0.0001|TWO_SIDED|95.0|1.3|3.0||p-value is adjusted for multiple comparisons by Hochberg method|ANCOVA|Adjusted by level of baseline bone mineral density T-score|Denosumab - Placebo|||3.0|1.3|<0.0001
72593502|NCT00980174|144718923|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.3|||<|0.0001|TWO_SIDED|95.0|1.4|3.2||p-value is adjusted for multiple comparisons by Hochberg method|ANCOVA|Adjusted by level of baseline bone mineral density T-score|Denosumab - Placebo|||3.2|1.4|<0.0001
72593503|NCT00980174|144718924|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.9||||0.0144|TWO_SIDED|95.0|0.2|1.6||p-value is adjusted for multiple comparisons by Hochberg method|ANCOVA|Adjusted by level of baseline bone mineral density T-score|Denosumab - Placebo|||1.6|0.2|0.0144
72593504|NCT00980174|144718925|SUPERIORITY_OR_OTHER||||||<|0.0001||||||p-value is adjusted for multiple comparisons by Hochberg method|Van Elteren Rank Test|Adjusted by level of baseline bone mineral density T-score||||||<0.0001
72593505|NCT00551161|144718952|SUPERIORITY_OR_OTHER||||||<|0.05||||||Due to the exploratory nature of these analyses, no adjustment for multiple testing was made. Although it would have been preferable to carry out an omnibus analysis, due to the small sample size, the descriptive approach described above was used.|Wilcoxon (Mann-Whitney)|||The Wilcoxon signed-rank test was used to examine whether the change between t0 and t1 differed from the change between t1 and t2 \[(t2 - t1) - (t1 - t0)\] for each of the metabolites and ratios, in order to examine whether the rate of change differed while on monotherapy as compared with combination therapy.||||<0.05
72593506|NCT00772005|144718978|SUPERIORITY_OR_OTHER|||||||0.8514||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.8514
72593507|NCT00772005|144718978|SUPERIORITY_OR_OTHER|||||||0.6995||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.6995
72414869|NCT01571362|144339943|SUPERIORITY_OR_OTHER|||||||0.1272|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) stratified by prior pain analgesic (opioid or non-opioid)||||||0.1272
72593508|NCT00772005|144718978|SUPERIORITY_OR_OTHER|||||||0.9766||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.9766
72593509|NCT00772005|144718979|SUPERIORITY_OR_OTHER|||||||0.7596||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.7596
72593510|NCT00772005|144718979|SUPERIORITY_OR_OTHER|||||||0.562||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.5620
72593511|NCT00772005|144718979|SUPERIORITY_OR_OTHER|||||||0.6688||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.6688
72593512|NCT00772005|144718980|SUPERIORITY_OR_OTHER|||||||0.1894||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.1894
72593513|NCT00772005|144718980|SUPERIORITY_OR_OTHER|||||||0.4582||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.4582
72593514|NCT00772005|144718980|SUPERIORITY_OR_OTHER|||||||0.0327||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0327
72593515|NCT00772005|144718981|SUPERIORITY_OR_OTHER|||||||0.3275||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.3275
72593516|NCT00772005|144718981|SUPERIORITY_OR_OTHER|||||||0.2597||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.2597
72593517|NCT00772005|144718981|SUPERIORITY_OR_OTHER|||||||0.0039||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0039
72593518|NCT00772005|144718982|SUPERIORITY_OR_OTHER|||||||0.0713||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0713
72593519|NCT00772005|144718982|SUPERIORITY_OR_OTHER|||||||0.0431||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0431
72593520|NCT00772005|144718982|SUPERIORITY_OR_OTHER|||||||0.0063||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0063
72593521|NCT00772005|144718983|SUPERIORITY_OR_OTHER|||||||0.0619||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0619
72593522|NCT00772005|144718983|SUPERIORITY_OR_OTHER|||||||0.1137||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.1137
72593523|NCT00772005|144718983|SUPERIORITY_OR_OTHER|||||||0.0598||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0598
72593524|NCT00772005|144718984|SUPERIORITY_OR_OTHER|||||||0.7093||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.7093
72593525|NCT00772005|144718984|SUPERIORITY_OR_OTHER|||||||0.5129||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.5129
72593526|NCT00772005|144718984|SUPERIORITY_OR_OTHER|||||||0.1097||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.1097
72593527|NCT00772005|144718985|SUPERIORITY_OR_OTHER|||||||0.4291||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.4291
72593528|NCT00772005|144718985|SUPERIORITY_OR_OTHER|||||||0.3195||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.3195
72414870|NCT01571362|144339944|SUPERIORITY_OR_OTHER|||||||0.021|||||||Cochran-Mantel-Haenszel|CMH was stratified by prior pain analgesic (opioid and non-opioid).||||||0.0210
72414871|NCT01571362|144339945|SUPERIORITY_OR_OTHER|||||||0.0248|||||||Cochran-Mantel-Haenszel|The CMH test was stratified by prior pain analgesic (opioid or non-opioid).||||||0.0248
72414872|NCT01571362|144339946|SUPERIORITY_OR_OTHER|||||||0.009|||||||Cochran-Mantel-Haenszel|The CMH test was stratified by prior pain analgesic (opioid or non-opioid).||||||0.0090
72414873|NCT01571362|144339947|SUPERIORITY_OR_OTHER|||||||0.0874|||||||Cochran-Mantel-Haenszel|The CMH test was stratified by prior pain analgesic (opioid or non-opioid).||||||0.0874
72414874|NCT01571362|144339948|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||Change from Screening Period value to end of the OL Period for Worst Pain Score||||<0.0001
72414875|NCT01571362|144339948|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||Change from Screening Period value to end of the OL Period for Least Pain Score||||<0.0001
72414876|NCT01571362|144339948|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||Change from Screening Period value to end of the OL Period for Average Pain Score||||<0.0001
72414877|NCT01571362|144339948|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||Change from Screening Period value to end of the OL Period for Pain Right Now||||<0.0001
72414878|NCT01571362|144339948|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||Change from Screening Period value to end of the OL Period for Pain Severity Index||||<0.0001
72593529|NCT00772005|144718985|SUPERIORITY_OR_OTHER|||||||0.1591||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.1591
72414879|NCT01571362|144339948|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||Change from Screening Period value to end of the OL Period for Pain Interference Index||||<0.0001
72593530|NCT00772005|144718986|SUPERIORITY_OR_OTHER|||||||0.7768||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.7768
72593531|NCT00772005|144718986|SUPERIORITY_OR_OTHER|||||||0.4014||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.4014
72593532|NCT00772005|144718986|SUPERIORITY_OR_OTHER|||||||0.4016||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.4016
72593533|NCT00772005|144718987|SUPERIORITY_OR_OTHER|||||||0.5612||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.5612
72593534|NCT00772005|144718987|SUPERIORITY_OR_OTHER|||||||0.9704||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.9704
72593535|NCT00772005|144718987|SUPERIORITY_OR_OTHER|||||||0.2424||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.2424
72593536|NCT00772005|144718988|SUPERIORITY_OR_OTHER|||||||0.8847||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.8847
72593537|NCT00772005|144718988|SUPERIORITY_OR_OTHER|||||||0.2958||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.2958
72593538|NCT00772005|144718988|SUPERIORITY_OR_OTHER|||||||0.266||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.2660
72593539|NCT00772005|144718989|SUPERIORITY_OR_OTHER|||||||0.0524||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0524
72593540|NCT00772005|144718989|SUPERIORITY_OR_OTHER|||||||0.0328||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0328
72593541|NCT00772005|144718989|SUPERIORITY_OR_OTHER|||||||0.0084||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0084
72593542|NCT00772005|144718990|SUPERIORITY_OR_OTHER|||||||0.3651||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.3651
72593543|NCT00772005|144718990|SUPERIORITY_OR_OTHER|||||||0.0096||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0096
72593544|NCT00772005|144718990|SUPERIORITY_OR_OTHER|||||||0.0327||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0327
72593545|NCT00772005|144718991|SUPERIORITY_OR_OTHER|||||||0.2091||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.2091
72593546|NCT00772005|144718991|SUPERIORITY_OR_OTHER|||||||0.0706||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0706
72414880|NCT01571362|144339949|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||Change from Screening Period value to Randomization Baseline for Worst Pain Score||||<0.0001
72414881|NCT01571362|144339949|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||Change from Screening Period value to Randomization Baseline for Least Pain Score||||<0.0001
72414882|NCT01571362|144339949|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||Change from Screening Period value to Randomization Baseline for Average Pain Score||||<0.0001
72414883|NCT01571362|144339949|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||Change from Screening Period value to Randomization Baseline for Pain Right Now||||<0.0001
72593547|NCT00772005|144718991|SUPERIORITY_OR_OTHER|||||||0.3052||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.3052
72593548|NCT00772005|144718992|SUPERIORITY_OR_OTHER|||||||0.996||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.9960
72593549|NCT00772005|144718992|SUPERIORITY_OR_OTHER|||||||0.3604||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.3604
72593550|NCT00772005|144718992|SUPERIORITY_OR_OTHER|||||||0.9528||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.9528
72593551|NCT00772005|144718993|SUPERIORITY_OR_OTHER|||||||0.9797||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.9797
72593552|NCT00772005|144718993|SUPERIORITY_OR_OTHER|||||||0.6173||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.6173
72593553|NCT00772005|144718993|SUPERIORITY_OR_OTHER|||||||0.5415||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.5415
72593554|NCT00772005|144718994|SUPERIORITY_OR_OTHER|||||||0.3547||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.3547
72593555|NCT00772005|144718994|SUPERIORITY_OR_OTHER|||||||0.6642||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.6642
72593556|NCT00772005|144718994|SUPERIORITY_OR_OTHER|||||||0.7395||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.7395
72593557|NCT00772005|144718995|SUPERIORITY_OR_OTHER|||||||0.8124||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.8124
72593558|NCT00772005|144718995|SUPERIORITY_OR_OTHER|||||||0.8961||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.8961
72593559|NCT00772005|144718995|SUPERIORITY_OR_OTHER|||||||0.4999||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.4999
72593560|NCT00772005|144719005|SUPERIORITY_OR_OTHER|||||||0.454||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.4540
72593561|NCT00772005|144719005|SUPERIORITY_OR_OTHER|||||||0.358||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.3580
72593562|NCT00772005|144719005|SUPERIORITY_OR_OTHER|||||||0.6271||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.6271
72593563|NCT00772005|144719006|SUPERIORITY_OR_OTHER|||||||0.1459||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.1459
72414884|NCT01571362|144339949|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||Change from Screening Period value to Randomization Baseline for Pain Severity Index||||<0.0001
72414885|NCT01571362|144339949|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||Change from Screening Period value to Randomization Baseline for Pain Interference Index||||<0.0001
72414886|NCT01571362|144339950|SUPERIORITY_OR_OTHER||Difference of LS Means|-0.62|STANDARD_ERROR_OF_MEAN|0.222||0.0056|TWO_SIDED|95.0|-1.06|-0.18|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|Difference between treatment groups in change from Randomization Baseline to Week 2.||-0.18|-1.06|0.0056
72414887|NCT01571362|144339950|SUPERIORITY_OR_OTHER||Difference of LS Means|-0.64|STANDARD_ERROR_OF_MEAN|0.243||0.009|TWO_SIDED|95.0|-1.12|-0.16|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|Difference between treatment groups in change from Randomization Baseline to Week 4.||-0.16|-1.12|0.0090
72414888|NCT01571362|144339950|SUPERIORITY_OR_OTHER||Difference of LS Means|-0.37|STANDARD_ERROR_OF_MEAN|0.271||0.1684|TWO_SIDED|95.0|-0.91|0.16|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|Difference between treatment groups in change from Randomization Baseline to Week 8.||0.16|-0.91|0.1684
72414889|NCT01571362|144339950|SUPERIORITY_OR_OTHER||Difference of LS Means|-0.98|STANDARD_ERROR_OF_MEAN|0.244|<|0.0001|TWO_SIDED|95.0|-1.46|-0.5|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|Difference between treatment groups in change from Randomization Baseline to Week 12/Early Termination.||-0.50|-1.46|<0.0001
72414890|NCT01571362|144339951|SUPERIORITY_OR_OTHER||Difference of LS Means|-0.4|STANDARD_ERROR_OF_MEAN|0.193||0.0412|TWO_SIDED|95.0|-0.78|-0.02|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|Difference between treatment groups in change from Randomization Baseline to Week 2||-0.02|-0.78|0.0412
72421581|NCT01337986|144354302|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.46||||0.04|TWO_SIDED|95.0|1.02|2.1||Probability of being in the lowest quartile for Visual Field Index deficits.|Regression, Logistic||Odds Ratio for Visual Field Index|||2.10|1.02|0.04
72593564|NCT00772005|144719006|SUPERIORITY_OR_OTHER|||||||0.6004||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.6004
72593565|NCT00772005|144719006|SUPERIORITY_OR_OTHER|||||||0.0192||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0192
72593566|NCT00772005|144719007|SUPERIORITY_OR_OTHER|||||||0.8455||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.8455
72593567|NCT00772005|144719007|SUPERIORITY_OR_OTHER|||||||0.8715||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.8715
72593568|NCT00772005|144719007|SUPERIORITY_OR_OTHER|||||||0.0309||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0309
72593569|NCT00772005|144719008|SUPERIORITY_OR_OTHER|||||||0.2664||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.2664
72593570|NCT00772005|144719008|SUPERIORITY_OR_OTHER|||||||0.3528||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.3528
72593571|NCT00772005|144719008|SUPERIORITY_OR_OTHER|||||||0.038||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0380
72593572|NCT00772005|144719009|SUPERIORITY_OR_OTHER|||||||0.3316||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.3316
72593573|NCT00772005|144719009|SUPERIORITY_OR_OTHER|||||||0.349||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.3490
72593574|NCT00772005|144719009|SUPERIORITY_OR_OTHER|||||||0.0926||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0926
72593575|NCT00772005|144719010|SUPERIORITY_OR_OTHER|||||||0.8835||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.8835
72593576|NCT00772005|144719010|SUPERIORITY_OR_OTHER|||||||0.9748||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.9748
72593577|NCT00772005|144719010|SUPERIORITY_OR_OTHER|||||||0.0883||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0883
72593578|NCT00772005|144719011|SUPERIORITY_OR_OTHER|||||||0.6948||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.6948
72414891|NCT01571362|144339951|SUPERIORITY_OR_OTHER||Difference of LS Means|-0.87|STANDARD_ERROR_OF_MEAN|0.201|<|0.0001|TWO_SIDED|95.0|-1.27|-0.48|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|Difference between treatment groups in change from Randomization Baseline to Week 4||-0.48|-1.27|<0.0001
72414892|NCT01571362|144339951|SUPERIORITY_OR_OTHER||Difference of LS Means|-0.64|STANDARD_ERROR_OF_MEAN|0.226||0.0055|TWO_SIDED|95.0|-1.08|-0.19|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|Difference between treatment groups in change from Randomization Baseline to Week 8.||-0.19|-1.08|0.0055
72593579|NCT00772005|144719011|SUPERIORITY_OR_OTHER|||||||0.3345||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.3345
72414893|NCT01571362|144339951|SUPERIORITY_OR_OTHER||Difference of LS Means|-0.86|STANDARD_ERROR_OF_MEAN|0.21|<|0.0001|TWO_SIDED|95.0|-1.27|-0.44|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|Difference between treatment groups in change from Randomization Baseline to Week 12/Early Termination.||-0.44|-1.27|<0.0001
72414894|NCT01571362|144339952|SUPERIORITY_OR_OTHER||Difference of LS Means|-0.65|STANDARD_ERROR_OF_MEAN|0.19||0.0007|TWO_SIDED|95.0|-1.02|-0.27|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|Difference between treatment groups in change from Randomization Baseline to Week 2.||-0.27|-1.02|0.0007
72421582|NCT01337986|144354303|SUPERIORITY_OR_OTHER_LEGACY|||||||0.94|||||||Regression, Logistic|||||||0.94
72421583|NCT01337986|144354304|SUPERIORITY|||||||0.39|||||||Wilcoxon (Mann-Whitney)|||||||0.39
72593580|NCT00772005|144719011|SUPERIORITY_OR_OTHER|||||||0.2447||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.2447
72421584|NCT01337986|144354305|SUPERIORITY_OR_OTHER_LEGACY|||||||0.72|||||||Regression, Linear|||||||0.72
72593581|NCT00772005|144719012|SUPERIORITY_OR_OTHER|||||||0.6115||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.6115
72593582|NCT00772005|144719012|SUPERIORITY_OR_OTHER|||||||0.2233||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.2233
72593583|NCT00772005|144719012|SUPERIORITY_OR_OTHER|||||||0.2343||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.2343
72593584|NCT00772005|144719013|SUPERIORITY_OR_OTHER|||||||0.8228||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.8228
72593585|NCT00772005|144719013|SUPERIORITY_OR_OTHER|||||||0.9373||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.9373
72593586|NCT00772005|144719013|SUPERIORITY_OR_OTHER|||||||0.319||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.3190
72593587|NCT00772005|144719014|SUPERIORITY_OR_OTHER|||||||0.9769||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.9769
72593588|NCT00772005|144719014|SUPERIORITY_OR_OTHER|||||||0.8374||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.8374
72593589|NCT00772005|144719014|SUPERIORITY_OR_OTHER|||||||0.7061||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.7061
72593590|NCT00772005|144719015|SUPERIORITY_OR_OTHER|||||||0.9577||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.9577
72593591|NCT00772005|144719015|SUPERIORITY_OR_OTHER|||||||0.5106||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.5106
72593592|NCT00772005|144719015|SUPERIORITY_OR_OTHER|||||||0.2655||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.2655
72593593|NCT00772005|144719016|SUPERIORITY_OR_OTHER|||||||0.3825||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.3825
72593594|NCT00772005|144719016|SUPERIORITY_OR_OTHER|||||||0.2003||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.2003
72593595|NCT00772005|144719016|SUPERIORITY_OR_OTHER|||||||0.0625||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0625
72593596|NCT00772005|144719017|SUPERIORITY_OR_OTHER|||||||0.2981||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.2981
72593597|NCT00772005|144719017|SUPERIORITY_OR_OTHER|||||||0.0104||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0104
72593598|NCT00772005|144719017|SUPERIORITY_OR_OTHER|||||||0.015||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0150
72593599|NCT00772005|144719018|SUPERIORITY_OR_OTHER|||||||0.4608||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.4608
72593600|NCT00772005|144719018|SUPERIORITY_OR_OTHER|||||||0.0807||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0807
72593601|NCT00772005|144719018|SUPERIORITY_OR_OTHER|||||||0.2959||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.2959
72593602|NCT00772005|144719019|SUPERIORITY_OR_OTHER|||||||0.6759||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.6759
72593603|NCT00772005|144719019|SUPERIORITY_OR_OTHER|||||||0.2418||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.2418
72593604|NCT00772005|144719019|SUPERIORITY_OR_OTHER|||||||0.9808||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.9808
72593605|NCT00772005|144719020|SUPERIORITY_OR_OTHER|||||||0.7599||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.7599
72593606|NCT00772005|144719020|SUPERIORITY_OR_OTHER|||||||0.4543||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.4543
72593607|NCT00772005|144719020|SUPERIORITY_OR_OTHER|||||||0.604||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.6040
72593608|NCT00772005|144719021|SUPERIORITY_OR_OTHER|||||||0.2476||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.2476
72593609|NCT00772005|144719021|SUPERIORITY_OR_OTHER|||||||0.949||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.9490
72593610|NCT00772005|144719021|SUPERIORITY_OR_OTHER|||||||0.9035||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.9035
72593611|NCT00772005|144719022|SUPERIORITY_OR_OTHER|||||||0.9472||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.9472
72593612|NCT00772005|144719022|SUPERIORITY_OR_OTHER|||||||0.8335||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.8335
72593613|NCT00772005|144719022|SUPERIORITY_OR_OTHER|||||||0.5674||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.5674
72593614|NCT00772005|144719023|SUPERIORITY_OR_OTHER|||||||0.3536||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.3536
72593615|NCT00772005|144719023|SUPERIORITY_OR_OTHER|||||||0.194||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.1940
72593616|NCT00772005|144719023|SUPERIORITY_OR_OTHER|||||||0.2129||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.2129
72593617|NCT00772005|144719024|SUPERIORITY_OR_OTHER|||||||0.584||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.5840
72593618|NCT00772005|144719024|SUPERIORITY_OR_OTHER|||||||0.6028||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.6028
72593619|NCT00772005|144719024|SUPERIORITY_OR_OTHER|||||||0.1426||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.1426
72593620|NCT00772005|144719025|SUPERIORITY_OR_OTHER|||||||0.5989||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.5989
72593621|NCT00772005|144719025|SUPERIORITY_OR_OTHER|||||||0.7411||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.7411
72593622|NCT00772005|144719025|SUPERIORITY_OR_OTHER|||||||0.1566||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.1566
72593623|NCT00772005|144719026|SUPERIORITY_OR_OTHER|||||||0.261||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.2610
72593624|NCT00772005|144719026|SUPERIORITY_OR_OTHER|||||||0.4457||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.4457
72593625|NCT00772005|144719026|SUPERIORITY_OR_OTHER|||||||0.1342||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.1342
72593626|NCT00772005|144719027|SUPERIORITY_OR_OTHER|||||||0.0974||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0974
72593627|NCT00772005|144719027|SUPERIORITY_OR_OTHER|||||||0.664||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.6640
72593628|NCT00772005|144719027|SUPERIORITY_OR_OTHER|||||||0.1507||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.1507
72593629|NCT00772005|144719028|SUPERIORITY_OR_OTHER|||||||0.7649||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.7649
72593630|NCT00772005|144719028|SUPERIORITY_OR_OTHER|||||||0.4866||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.4866
72593631|NCT00772005|144719028|SUPERIORITY_OR_OTHER|||||||0.5002||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.5002
72593632|NCT00772005|144719029|SUPERIORITY_OR_OTHER|||||||0.2076||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.2076
72593633|NCT00772005|144719029|SUPERIORITY_OR_OTHER|||||||0.9355||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.9355
72593634|NCT00772005|144719029|SUPERIORITY_OR_OTHER|||||||0.189||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.1890
72593635|NCT00772005|144719030|SUPERIORITY_OR_OTHER|||||||0.632||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.6320
72593636|NCT00772005|144719030|SUPERIORITY_OR_OTHER|||||||0.8777||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.8777
72593637|NCT00772005|144719030|SUPERIORITY_OR_OTHER|||||||0.4378||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.4378
72593638|NCT00772005|144719031|SUPERIORITY_OR_OTHER|||||||0.5544||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.5544
72593639|NCT00772005|144719031|SUPERIORITY_OR_OTHER|||||||0.4446||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.4446
72593640|NCT00772005|144719031|SUPERIORITY_OR_OTHER|||||||0.4483||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.4483
72593641|NCT00772005|144719032|SUPERIORITY_OR_OTHER|||||||0.1914||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.1914
72593642|NCT00772005|144719032|SUPERIORITY_OR_OTHER|||||||0.2543||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.2543
72593643|NCT00772005|144719032|SUPERIORITY_OR_OTHER|||||||0.9748||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.9748
72593644|NCT00772005|144719033|SUPERIORITY_OR_OTHER|||||||0.5312||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.5312
72593645|NCT00772005|144719033|SUPERIORITY_OR_OTHER|||||||0.7522||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.7522
72593646|NCT00772005|144719033|SUPERIORITY_OR_OTHER|||||||0.3183||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.3183
72593647|NCT00772005|144719034|SUPERIORITY_OR_OTHER|||||||0.5879||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.5879
72593648|NCT00772005|144719034|SUPERIORITY_OR_OTHER|||||||0.891||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.8910
72593649|NCT00772005|144719034|SUPERIORITY_OR_OTHER|||||||0.1795||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.1795
72593650|NCT00772005|144719035|SUPERIORITY_OR_OTHER|||||||0.6378||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.6378
72593651|NCT00772005|144719035|SUPERIORITY_OR_OTHER|||||||0.8679||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.8679
72593652|NCT00772005|144719035|SUPERIORITY_OR_OTHER|||||||0.5489||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.5489
72593653|NCT00772005|144719036|SUPERIORITY_OR_OTHER|||||||0.9337||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.9337
72593654|NCT00772005|144719036|SUPERIORITY_OR_OTHER|||||||0.9428||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.9428
72593655|NCT00772005|144719036|SUPERIORITY_OR_OTHER|||||||0.5895||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.5895
72593656|NCT00772005|144719037|SUPERIORITY_OR_OTHER|||||||0.8695||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.8695
72593657|NCT00772005|144719037|SUPERIORITY_OR_OTHER|||||||0.6637||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.6637
72593658|NCT00772005|144719037|SUPERIORITY_OR_OTHER|||||||0.3152||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.3152
72593659|NCT00772005|144719038|SUPERIORITY_OR_OTHER|||||||0.7472||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.7472
72593660|NCT00772005|144719038|SUPERIORITY_OR_OTHER|||||||0.4503||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.4503
72593661|NCT00772005|144719038|SUPERIORITY_OR_OTHER|||||||0.3127||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.3127
72593662|NCT00772005|144719039|SUPERIORITY_OR_OTHER|||||||0.9193||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.9193
72593663|NCT00772005|144719039|SUPERIORITY_OR_OTHER|||||||0.4814||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.4814
72593664|NCT00772005|144719039|SUPERIORITY_OR_OTHER|||||||0.6097||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.6097
72593665|NCT00772005|144719040|SUPERIORITY_OR_OTHER|||||||0.8594||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.8594
72593666|NCT00772005|144719040|SUPERIORITY_OR_OTHER|||||||0.6157||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.6157
72593667|NCT00772005|144719040|SUPERIORITY_OR_OTHER|||||||0.4846||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.4846
72593668|NCT00772005|144719041|SUPERIORITY_OR_OTHER|||||||0.6076||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.6076
72593669|NCT00772005|144719041|SUPERIORITY_OR_OTHER|||||||0.5827||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.5827
72414895|NCT01571362|144339952|SUPERIORITY_OR_OTHER||Difference of LS Means|-0.74|STANDARD_ERROR_OF_MEAN|0.213||0.0006|TWO_SIDED|95.0|-1.16|-0.32|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|Difference between treatment groups in change from Randomization Baseline to Week 4.||-0.32|-1.16|0.0006
72414896|NCT01571362|144339952|SUPERIORITY_OR_OTHER||Difference of LS Means|-0.64|STANDARD_ERROR_OF_MEAN|0.236||0.007|TWO_SIDED|95.0|-1.11|-0.18|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|Difference between treatment groups in change from Randomization Baseline to Week 8.||-0.18|-1.11|0.0070
72414897|NCT01571362|144339952|SUPERIORITY_OR_OTHER||Difference of LS Means|-0.88|STANDARD_ERROR_OF_MEAN|0.221|<|0.0001|TWO_SIDED|95.0|-1.31|-0.44|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|Difference between treatment groups in change from Randomization Baseline to Week 12/Early Termination.||-0.44|-1.31|<0.0001
72414898|NCT01571362|144339953|SUPERIORITY_OR_OTHER||Difference of LS Means|-0.64|STANDARD_ERROR_OF_MEAN|0.207||0.0022|TWO_SIDED|95.0|-1.05|-0.23|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|Difference between treatment groups in change from Randomization Baseline to Week 2.||-0.23|-1.05|0.0022
72414899|NCT01571362|144339953|SUPERIORITY_OR_OTHER||Difference of LS Means|-0.79|STANDARD_ERROR_OF_MEAN|0.214||0.0003|TWO_SIDED|95.0|-1.21|-0.37|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|Difference between treatment groups in change from Randomization Baseline to Week 4.||-0.37|-1.21|0.0003
72593670|NCT00772005|144719041|SUPERIORITY_OR_OTHER|||||||0.7865||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.7865
72414900|NCT01571362|144339953|SUPERIORITY_OR_OTHER||Difference of LS Means|-0.71|STANDARD_ERROR_OF_MEAN|0.264||0.0078|TWO_SIDED|95.0|-1.23|-0.19|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|Difference between treatment groups in change from Randomization Baseline to Week 8.||-0.19|-1.23|0.0078
72593671|NCT00772005|144719042|SUPERIORITY_OR_OTHER|||||||0.3045||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.3045
72593672|NCT00772005|144719042|SUPERIORITY_OR_OTHER|||||||0.0617||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0617
72593673|NCT00772005|144719042|SUPERIORITY_OR_OTHER|||||||0.058||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0580
72593674|NCT00772005|144719043|SUPERIORITY_OR_OTHER|||||||0.0194||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0194
72593675|NCT00772005|144719043|SUPERIORITY_OR_OTHER|||||||0.227||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.2270
72593676|NCT00772005|144719043|SUPERIORITY_OR_OTHER|||||||0.1181||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.1181
72593677|NCT00772005|144719044|SUPERIORITY_OR_OTHER|||||||0.1348||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.1348
72593678|NCT00772005|144719044|SUPERIORITY_OR_OTHER|||||||0.0419||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0419
72593679|NCT00772005|144719044|SUPERIORITY_OR_OTHER|||||||0.0146||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0146
72593680|NCT00772005|144719045|SUPERIORITY_OR_OTHER|||||||0.1292||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.1292
72593681|NCT00772005|144719045|SUPERIORITY_OR_OTHER|||||||0.3773||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.3773
72593682|NCT00772005|144719045|SUPERIORITY_OR_OTHER|||||||0.1348||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.1348
72593683|NCT00772005|144719046|SUPERIORITY_OR_OTHER|||||||0.9642||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.9642
72593684|NCT00772005|144719046|SUPERIORITY_OR_OTHER|||||||0.7814||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.7814
72593685|NCT00772005|144719046|SUPERIORITY_OR_OTHER|||||||0.1455||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.1455
72593686|NCT00772005|144719047|SUPERIORITY_OR_OTHER|||||||0.5722||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.5722
72593687|NCT00772005|144719047|SUPERIORITY_OR_OTHER|||||||0.1352||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.1352
72593688|NCT00772005|144719047|SUPERIORITY_OR_OTHER|||||||0.063||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0630
72593689|NCT00772005|144719048|SUPERIORITY_OR_OTHER|||||||0.4607||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.4607
72593690|NCT00772005|144719048|SUPERIORITY_OR_OTHER|||||||0.2538||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.2538
72593691|NCT00772005|144719048|SUPERIORITY_OR_OTHER|||||||0.3406||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.3406
72593692|NCT00772005|144719049|SUPERIORITY_OR_OTHER|||||||0.8116||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.8116
72593693|NCT00772005|144719049|SUPERIORITY_OR_OTHER|||||||0.687||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.6870
72593694|NCT00772005|144719049|SUPERIORITY_OR_OTHER|||||||0.8112||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.8112
72593695|NCT00772005|144719050|SUPERIORITY_OR_OTHER|||||||0.9786||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.9786
72593696|NCT00772005|144719050|SUPERIORITY_OR_OTHER|||||||0.5879||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.5879
72593697|NCT00772005|144719050|SUPERIORITY_OR_OTHER|||||||0.3973||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.3973
72414901|NCT01571362|144339953|SUPERIORITY_OR_OTHER||Difference of LS Means|-1.07|STANDARD_ERROR_OF_MEAN|0.231|<|0.0001|TWO_SIDED|95.0|-1.52|-0.62|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|Difference between treatment groups in change from Randomization Baseline to Week 12/Early Termination.||-0.62|-1.52|<0.0001
72414902|NCT01571362|144339954|SUPERIORITY_OR_OTHER||Difference of LS Means|-0.58|STANDARD_ERROR_OF_MEAN|0.189||0.0022|TWO_SIDED|95.0|-0.95|-0.21|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|Difference between treatment groups in change from Randomization Baseline to Week 2.||-0.21|-0.95|0.0022
72414903|NCT01571362|144339954|SUPERIORITY_OR_OTHER||Difference of LS Means|-0.76|STANDARD_ERROR_OF_MEAN|0.198||0.0002|TWO_SIDED|95.0|-1.15|-0.37|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|Difference between treatment groups in change from Randomization Baseline to Week 4.||-0.37|-1.15|0.0002
72414904|NCT01571362|144339954|SUPERIORITY_OR_OTHER||Difference of LS Means|-0.61|STANDARD_ERROR_OF_MEAN|0.228||0.0078|TWO_SIDED|95.0|-1.06|-0.16|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|Difference between treatment groups in change from Randomization Baseline to Week 8.||-0.16|-1.06|0.0078
72593698|NCT00772005|144719051|SUPERIORITY_OR_OTHER|||||||0.403||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.4030
72593699|NCT00772005|144719051|SUPERIORITY_OR_OTHER|||||||0.3777||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.3777
72593700|NCT00772005|144719051|SUPERIORITY_OR_OTHER|||||||0.6493||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.6493
72593701|NCT00772005|144719052|SUPERIORITY_OR_OTHER|||||||0.9871||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.9871
72593702|NCT00772005|144719052|SUPERIORITY_OR_OTHER|||||||0.5859||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.5859
72593703|NCT00772005|144719052|SUPERIORITY_OR_OTHER|||||||0.0328||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0328
72593704|NCT00772005|144719053|SUPERIORITY_OR_OTHER|||||||0.2318||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.2318
72593705|NCT00772005|144719053|SUPERIORITY_OR_OTHER|||||||0.6211||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.6211
72593706|NCT00772005|144719053|SUPERIORITY_OR_OTHER|||||||0.3125||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.3125
72593707|NCT00772005|144719054|SUPERIORITY_OR_OTHER|||||||0.2425||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.2425
72593708|NCT00772005|144719054|SUPERIORITY_OR_OTHER|||||||0.6597||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.6597
72593709|NCT00772005|144719054|SUPERIORITY_OR_OTHER|||||||0.4753||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.4753
72593710|NCT00772005|144719055|SUPERIORITY_OR_OTHER|||||||0.1715||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.1715
72593711|NCT00772005|144719055|SUPERIORITY_OR_OTHER|||||||0.3056||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.3056
72593712|NCT00772005|144719055|SUPERIORITY_OR_OTHER|||||||0.0083||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0083
72593713|NCT00772005|144719056|SUPERIORITY_OR_OTHER|||||||0.2681||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.2681
72414905|NCT01571362|144339954|SUPERIORITY_OR_OTHER||Difference of LS Means|-0.95|STANDARD_ERROR_OF_MEAN|0.207|<|0.0001|TWO_SIDED|95.0|-1.35|-0.54|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|Difference between treatment groups in change from Randomization Baseline to Week 12/Early Termination.||-0.54|-1.35|<0.0001
72414906|NCT01571362|144339955|SUPERIORITY_OR_OTHER||Difference of LS Means|-0.41|STANDARD_ERROR_OF_MEAN|0.188||0.0285|TWO_SIDED|95.0|-0.78|-0.04|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|Difference between treatment groups in change from Randomization Baseline to Week 2.||-0.04|-0.78|0.0285
72414907|NCT01571362|144339955|SUPERIORITY_OR_OTHER||Difference of LS Means|-0.48|STANDARD_ERROR_OF_MEAN|0.188||0.0106|TWO_SIDED|95.0|-0.85|-0.11|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|Difference between treatment groups in change from Randomization Baseline to Week 4.||-0.11|-0.85|0.0106
72414908|NCT01571362|144339955|SUPERIORITY_OR_OTHER||Difference of LS Means|-0.17|STANDARD_ERROR_OF_MEAN|0.222||0.4529|TWO_SIDED|95.0|-0.6|0.27|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|Difference between treatment groups in change from Randomization Baseline to Week 8.||0.27|-0.60|0.4529
72414909|NCT01571362|144339955|SUPERIORITY_OR_OTHER||Difference of LS Means|-0.65|STANDARD_ERROR_OF_MEAN|0.207||0.0018|TWO_SIDED|95.0|-1.06|-0.25|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|Difference between treatment groups in change from Randomization Baseline to Week 12/Early Termination.||-0.25|-1.06|0.0018
72593714|NCT00772005|144719056|SUPERIORITY_OR_OTHER|||||||0.1475||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.1475
72593715|NCT00772005|144719056|SUPERIORITY_OR_OTHER|||||||0.0647||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0647
72593716|NCT00772005|144719057|SUPERIORITY_OR_OTHER|||||||0.167||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.1670
72593717|NCT00772005|144719057|SUPERIORITY_OR_OTHER|||||||0.1737||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.1737
72593718|NCT00772005|144719057|SUPERIORITY_OR_OTHER|||||||0.372||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.3720
72593719|NCT00772005|144719058|SUPERIORITY_OR_OTHER|||||||0.3547||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.3547
72593720|NCT00772005|144719058|SUPERIORITY_OR_OTHER|||||||0.6043||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.6043
72593721|NCT00772005|144719058|SUPERIORITY_OR_OTHER|||||||0.0463||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0463
72593722|NCT00772005|144719059|SUPERIORITY_OR_OTHER|||||||0.9258||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.9258
72593723|NCT00772005|144719059|SUPERIORITY_OR_OTHER|||||||0.9116||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.9116
72593724|NCT00772005|144719059|SUPERIORITY_OR_OTHER|||||||0.4848||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.4848
72593725|NCT00772005|144719060|SUPERIORITY_OR_OTHER|||||||0.7612||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.7612
72593726|NCT00772005|144719060|SUPERIORITY_OR_OTHER|||||||0.5761||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.5761
72593727|NCT00772005|144719060|SUPERIORITY_OR_OTHER|||||||0.1576||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.1576
72593728|NCT00772005|144719061|SUPERIORITY_OR_OTHER|||||||0.9565||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.9565
72593729|NCT00772005|144719061|SUPERIORITY_OR_OTHER|||||||0.9178||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.9178
72593730|NCT00772005|144719061|SUPERIORITY_OR_OTHER|||||||0.1491||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.1491
72593731|NCT00772005|144719062|SUPERIORITY_OR_OTHER|||||||0.7056||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.7056
72593732|NCT00772005|144719062|SUPERIORITY_OR_OTHER|||||||0.5179||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.5179
72593733|NCT00772005|144719062|SUPERIORITY_OR_OTHER|||||||0.4585||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.4585
72593734|NCT00772005|144719063|SUPERIORITY_OR_OTHER|||||||0.069||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0690
72593735|NCT00772005|144719063|SUPERIORITY_OR_OTHER|||||||0.5324||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.5324
72593736|NCT00772005|144719063|SUPERIORITY_OR_OTHER|||||||0.0946||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0946
72593737|NCT00772005|144719064|SUPERIORITY_OR_OTHER|||||||0.1878||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.1878
72593738|NCT00772005|144719064|SUPERIORITY_OR_OTHER|||||||0.4294||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.4294
72593739|NCT00772005|144719064|SUPERIORITY_OR_OTHER|||||||0.6504||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.6504
72593740|NCT00772005|144719065|SUPERIORITY_OR_OTHER|||||||0.4022||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.4022
72593741|NCT00772005|144719065|SUPERIORITY_OR_OTHER|||||||0.6246||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.6246
72593742|NCT00772005|144719065|SUPERIORITY_OR_OTHER|||||||0.8655||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.8655
72593743|NCT00772005|144719066|SUPERIORITY_OR_OTHER|||||||0.5676||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.5676
72593744|NCT00772005|144719066|SUPERIORITY_OR_OTHER|||||||0.5239||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.5239
72593745|NCT00772005|144719066|SUPERIORITY_OR_OTHER|||||||0.4092||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.4092
72593746|NCT00772005|144719067|SUPERIORITY_OR_OTHER|||||||0.5195||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.5195
72593747|NCT00772005|144719067|SUPERIORITY_OR_OTHER|||||||0.1732||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.1732
72593748|NCT00772005|144719067|SUPERIORITY_OR_OTHER|||||||0.7455||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.7455
72414910|NCT01571362|144339956|SUPERIORITY_OR_OTHER||Difference of LS Means|-0.71|STANDARD_ERROR_OF_MEAN|0.258||0.0061|TWO_SIDED|95.0|-1.22|-0.2|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariate.|Difference between treatment groups in change from Screening to Week 2.||-0.20|-1.22|0.0061
72593749|NCT00772005|144719068|SUPERIORITY_OR_OTHER|||||||0.6885||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.6885
72593750|NCT00772005|144719068|SUPERIORITY_OR_OTHER|||||||0.5443||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.5443
72593751|NCT00772005|144719068|SUPERIORITY_OR_OTHER|||||||0.9343||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.9343
72593752|NCT00772005|144719069|SUPERIORITY_OR_OTHER|||||||0.9093||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.9093
72593753|NCT00772005|144719069|SUPERIORITY_OR_OTHER|||||||0.4701||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.4701
72593754|NCT00772005|144719069|SUPERIORITY_OR_OTHER|||||||0.9764||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.9764
72593755|NCT00772005|144719070|SUPERIORITY_OR_OTHER|||||||0.8115||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.8115
72593756|NCT00772005|144719070|SUPERIORITY_OR_OTHER|||||||0.5378||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.5378
72593757|NCT00772005|144719070|SUPERIORITY_OR_OTHER|||||||0.9144||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.9144
72593758|NCT00772005|144719071|SUPERIORITY_OR_OTHER|||||||0.9812||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.9812
72593759|NCT00772005|144719071|SUPERIORITY_OR_OTHER|||||||0.5464||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.5464
72593760|NCT00772005|144719071|SUPERIORITY_OR_OTHER|||||||0.8811||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.8811
72593761|NCT00772005|144719072|SUPERIORITY_OR_OTHER|||||||0.6487||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.6487
72593762|NCT00772005|144719072|SUPERIORITY_OR_OTHER|||||||0.4204||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.4204
72593763|NCT00772005|144719072|SUPERIORITY_OR_OTHER|||||||0.6955||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.6955
72593764|NCT00772005|144719073|SUPERIORITY_OR_OTHER|||||||0.6042||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.6042
72593765|NCT00772005|144719073|SUPERIORITY_OR_OTHER|||||||0.9783||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.9783
72593766|NCT00772005|144719073|SUPERIORITY_OR_OTHER|||||||0.9739||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.9739
72593767|NCT00772005|144719074|SUPERIORITY_OR_OTHER|||||||0.3466||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.3466
72593768|NCT00772005|144719074|SUPERIORITY_OR_OTHER|||||||0.8469||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.8469
72593769|NCT00772005|144719074|SUPERIORITY_OR_OTHER|||||||0.5439||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.5439
72593770|NCT00772005|144719075|SUPERIORITY_OR_OTHER|||||||0.6059||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.6059
72593771|NCT00772005|144719075|SUPERIORITY_OR_OTHER|||||||0.7474||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.7474
72593772|NCT00772005|144719075|SUPERIORITY_OR_OTHER|||||||0.4424||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.4424
72593773|NCT00772005|144719076|SUPERIORITY_OR_OTHER|||||||0.4874||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.4874
72593774|NCT00772005|144719076|SUPERIORITY_OR_OTHER|||||||0.8243||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.8243
72593775|NCT00772005|144719076|SUPERIORITY_OR_OTHER|||||||0.9562||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.9562
72593776|NCT00772005|144719077|SUPERIORITY_OR_OTHER|||||||0.3686||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.3686
72593777|NCT00772005|144719077|SUPERIORITY_OR_OTHER|||||||0.027||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0270
72593778|NCT00772005|144719077|SUPERIORITY_OR_OTHER|||||||0.7322||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.7322
72593779|NCT00772005|144719078|SUPERIORITY_OR_OTHER|||||||0.4646||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.4646
72593780|NCT00772005|144719078|SUPERIORITY_OR_OTHER|||||||0.8783||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.8783
72593781|NCT00772005|144719078|SUPERIORITY_OR_OTHER|||||||0.4213||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.4213
72593782|NCT00772005|144719079|SUPERIORITY_OR_OTHER|||||||0.6597||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.6597
72593783|NCT00772005|144719079|SUPERIORITY_OR_OTHER|||||||0.0262||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0262
72593784|NCT00772005|144719079|SUPERIORITY_OR_OTHER|||||||0.6652||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.6652
72593785|NCT00772005|144719080|SUPERIORITY_OR_OTHER|||||||0.3355||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.3355
72593786|NCT00772005|144719080|SUPERIORITY_OR_OTHER|||||||0.0953||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0953
72593787|NCT00772005|144719080|SUPERIORITY_OR_OTHER|||||||0.9235||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.9235
72593788|NCT00772005|144719081|SUPERIORITY_OR_OTHER|||||||0.4164||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.4164
72414911|NCT01571362|144339956|SUPERIORITY_OR_OTHER||Difference of LS Means|-0.73|STANDARD_ERROR_OF_MEAN|0.277||0.0087|TWO_SIDED|95.0|-1.28|-0.19|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariate.|Difference between treatment groups in change from Screening to Week 4.||-0.19|-1.28|0.0087
72414912|NCT01571362|144339956|SUPERIORITY_OR_OTHER||Difference of LS Means|-0.56|STANDARD_ERROR_OF_MEAN|0.315||0.0769|TWO_SIDED|95.0|-1.18|0.06|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariate.|Difference between treatment groups in change from Screening to Week 8.||0.06|-1.18|0.0769
72414913|NCT01571362|144339956|SUPERIORITY_OR_OTHER||Difference of LS Means|-1.1|STANDARD_ERROR_OF_MEAN|0.289||0.0002|TWO_SIDED|95.0|-1.67|-0.53|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariate.|Difference between treatment groups in change from Screening to Week 12/Early Termination.||-0.53|-1.67|0.0002
72414914|NCT01571362|144339957|SUPERIORITY_OR_OTHER||Difference of LS Means|-0.51|STANDARD_ERROR_OF_MEAN|0.224||0.025|TWO_SIDED|95.0|-0.95|-0.06|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariate.|Difference between treatment groups in change from Screening to Week 2.||-0.06|-0.95|0.0250
72593789|NCT00772005|144719081|SUPERIORITY_OR_OTHER|||||||0.3003||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.3003
72593790|NCT00772005|144719081|SUPERIORITY_OR_OTHER|||||||0.6907||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.6907
72593791|NCT00772005|144719082|SUPERIORITY_OR_OTHER|||||||0.2518||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.2518
72593792|NCT00772005|144719082|SUPERIORITY_OR_OTHER|||||||0.0739||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0739
72593793|NCT00772005|144719082|SUPERIORITY_OR_OTHER|||||||0.5644||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.5644
72593794|NCT00772005|144719083|SUPERIORITY_OR_OTHER|||||||0.4305||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.4305
72593795|NCT00772005|144719083|SUPERIORITY_OR_OTHER|||||||0.8299||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.8299
72593796|NCT00772005|144719083|SUPERIORITY_OR_OTHER|||||||0.7283||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.7283
72593797|NCT00772005|144719084|SUPERIORITY_OR_OTHER|||||||0.761||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.7610
72593798|NCT00772005|144719084|SUPERIORITY_OR_OTHER|||||||0.6091||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.6091
72593799|NCT00772005|144719084|SUPERIORITY_OR_OTHER|||||||0.3368||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.3368
72593800|NCT00772005|144719085|SUPERIORITY_OR_OTHER|||||||0.8457||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.8457
72593801|NCT00772005|144719085|SUPERIORITY_OR_OTHER|||||||0.4531||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.4531
72593802|NCT00772005|144719085|SUPERIORITY_OR_OTHER|||||||0.6867||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.6867
72593803|NCT00772005|144719086|SUPERIORITY_OR_OTHER|||||||0.9705||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.9705
72593804|NCT00772005|144719086|SUPERIORITY_OR_OTHER|||||||0.0021||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0021
72593805|NCT00772005|144719086|SUPERIORITY_OR_OTHER|||||||0.5013||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.5013
72593806|NCT00772005|144719087|SUPERIORITY_OR_OTHER|||||||0.733||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.7330
72593807|NCT00772005|144719087|SUPERIORITY_OR_OTHER|||||||0.0068||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0068
72593808|NCT00772005|144719087|SUPERIORITY_OR_OTHER|||||||0.104||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.1040
72593809|NCT00772005|144719088|SUPERIORITY_OR_OTHER|||||||0.822||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.8220
72593810|NCT00772005|144719088|SUPERIORITY_OR_OTHER|||||||0.0144||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0144
72593811|NCT00772005|144719088|SUPERIORITY_OR_OTHER|||||||0.9464||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.9464
72593812|NCT03280225|144719148|OTHER||Odds Ratio (OR)|1.43||||0.302|TWO_SIDED|95.0|0.73|2.82|||Regression, Logistic||Odds ratios were estimated using GEE to control for clustering within VAMCs. Fixed effects included a time-dependent variable (pre-post) as well an independent variable of time to account for improvement due to secular trends.|Odds Ratio of eligible Veterans being assigned a coordinator during the 6 month period following implementation compared to eligible Veterans being assigned a coordinator in the 6 month period prior to implementation.||2.82|0.73|.302
72593813|NCT03280225|144719149|OTHER||Odds Ratio (OR)|1.29||||0.226|TWO_SIDED|95.0|0.86|1.93|||Regression, Logistic||Odds ratios were estimated using GEE to control for clustering within VAMCs. Fixed effects included a time-dependent variable (pre-post) as well an independent variable of time to account for improvement due to secular trends.|Odds Ratio of eligible Veterans being assigned a provider during the 6 month period following implementation compared to eligible Veterans being assigned a provider in the 6 month period prior to implementation.||1.93|0.86|0.226
72593814|NCT03280225|144719150|OTHER||Odds Ratio (OR)|1.23||||0.199|TWO_SIDED|95.0|0.9|1.7|||Regression, Logistic||Odds ratios were estimated using GEE to control for clustering within VAMCs. Fixed effects included a time-dependent variable (pre-post) as well an independent variable of time to account for improvement due to secular trends.|Odds Ratio of eligible Veterans receiving a care evaluation during the 6 month period following implementation compared to eligible Veterans receiving a care evaluation in the 6 month period prior to implementation.||1.70|0.90|0.199
72593815|NCT03280225|144719151|OTHER||Odds Ratio (OR)|1.38||||0.011|TWO_SIDED|95.0|1.08|1.76|||Regression, Logistic||Odds ratios were estimated using GEE to control for clustering within VAMCs. Fixed effects included a time-dependent variable (pre-post) as well an independent variable of time to account for improvement due to secular trends.|Odds Ratio of eligible Veterans where outreach was attempted during the 6 month period following implementation compared to eligible Veterans where outreach was attempted in the 6 month period prior to implementation.||1.76|1.08|0.011
72593816|NCT03280225|144719152|SUPERIORITY|||||||0.018|||||||ANOVA|F (4, 158) = 3.08||Program Needs||||.018
72593817|NCT03280225|144719152|SUPERIORITY|||||||0.136|||||||ANOVA|F (4, 158) = 1.78||Training Needs||||.136
72593818|NCT03280225|144719152|SUPERIORITY|Pressure for Change||||||0.812|||||||ANOVA|F (4, 158) = 0.39||||||.812
72593819|NCT03280225|144719152|SUPERIORITY|Staffing||||||0.358|||||||ANOVA|F (4, 158) = 1.10||||||.358
72593820|NCT03280225|144719152|SUPERIORITY|Mission||||||0.748|||||||ANOVA|F (4, 158) = 0.48||||||.748
72593821|NCT03280225|144719152|SUPERIORITY|||||||0.748|||||||ANOVA|F (4, 158) = 0.48||Cohesion||||.748
72593822|NCT03280225|144719152|SUPERIORITY|||||||0.005|||||||ANOVA|F (4, 158) = 3.88||Autonomy||||.005
72593823|NCT03280225|144719152|SUPERIORITY|||||||0.224|||||||ANOVA|F (4, 158) = 1.44||Communication||||.224
72593824|NCT03280225|144719152|SUPERIORITY|||||||0.043|||||||ANOVA|F (4, 158) = 2.52||Stress||||.043
72593825|NCT03280225|144719152|SUPERIORITY|||||||0.096|||||||ANOVA|F (4, 158) = 2.01||Change||||.096
72593826|NCT01260272|144719190|SUPERIORITY_OR_OTHER||||||=|0.033||||||Apriori threshold for statistical significance was \<=0.05|t-test, 2 sided|||||||=0.033
72593827|NCT01260272|144719191|SUPERIORITY_OR_OTHER||||||=|0.0468||||||Apriori threshold for statistical significance was \<=0.05|t-test, 2 sided|||||||=0.0468
72593828|NCT01260272|144719192|SUPERIORITY_OR_OTHER||||||=|0.2114||||||Apriori threshold for statistical significance was \<=0.05|t-test, 2 sided|||||||=0.2114
72593829|NCT01260272|144719193|SUPERIORITY_OR_OTHER||||||=|0.1727||||||Apriori threshold for statistical significance was \<=0.05|t-test, 2 sided|||||||=0.1727
72593830|NCT01260272|144719194|SUPERIORITY_OR_OTHER||||||=|0.7498||||||Apriori threshold for statistical significance was \<=0.05|Wilcoxon (Mann-Whitney)|||||||=0.7498
72593831|NCT01260272|144719195|SUPERIORITY_OR_OTHER||||||=|0.2615||||||Apriori threshold for statistical significance was \<=0.05|t-test, 2 sided|||||||=0.2615
72593832|NCT01260272|144719196|SUPERIORITY_OR_OTHER||||||=|0.6915||||||Apriori threshold for statistical significance was \<=0.05|t-test, 2 sided|||||||=0.6915
72593833|NCT01260272|144719197|SUPERIORITY_OR_OTHER|||||||0.106||||||Apriori threshold for statistical significance was \<=0.05|t-test, 2 sided|||||||0.1060
72593834|NCT00435487|144719198|NON_INFERIORITY_OR_EQUIVALENCE|The test of non-inferiority was based on whether the upper limit of the two-sided 95% confidence interval for the treatment group difference was less than or equal to 10%, the non-inferiority margin specified in the protocol.|Difference in proportion|-2.6||||||95.0|-8.59|3.4|||upper limit of 95% CI <= 10%||95% confidence interval (CI) is for difference in proportion using normal approximation to binomial. Non-inferiority was concluded if the upper boundary of the 95% CI for the Dalteparin - Unfractioned Heparin difference was less than or equal to 10%.|Death after receiving 48 hours of study medication (Event date - First dose date) and on or before day 30 from baseline. Difference in proportion (Dalteparin-UFH)(%).||3.40|-8.59|
72414915|NCT01571362|144339957|SUPERIORITY_OR_OTHER||Difference of LS Means|-0.89|STANDARD_ERROR_OF_MEAN|0.234||0.0002|TWO_SIDED|95.0|-1.36|-0.43|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariate.|Difference between treatment groups in change from Screening to Week 4.||-0.43|-1.36|0.0002
72414916|NCT01571362|144339957|SUPERIORITY_OR_OTHER||Difference of LS Means|-0.77|STANDARD_ERROR_OF_MEAN|0.263||0.0038|TWO_SIDED|95.0|-1.29|-0.25|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariate.|Difference between treatment groups in change from Screening to Week 8.||-0.25|-1.29|0.0038
72414917|NCT01571362|144339957|SUPERIORITY_OR_OTHER||Difference of LS Means|-0.98|STANDARD_ERROR_OF_MEAN|0.243|<|0.0001|TWO_SIDED|95.0|-1.46|-0.5|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariate.|Difference between treatment groups in change from Screening to Week 12/Early Termination.||-0.50|-1.46|<0.0001
72414918|NCT01571362|144339958|SUPERIORITY_OR_OTHER||Difference of LS Means|-0.8|STANDARD_ERROR_OF_MEAN|0.214||0.0002|TWO_SIDED|95.0|-1.22|-0.38|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariate.|Difference between treatment groups in change from Screening to Week 2.||-0.38|-1.22|0.0002
72593835|NCT00435487|144719198|NON_INFERIORITY_OR_EQUIVALENCE|The test of non-inferiority was based on whether the upper limit of the two-sided 95% confidence interval for the treatment group difference was less than or equal to 10%, the non-inferiority margin specified in the protocol.|Difference in proportion|1.25||||||95.0|-3.02|5.52|||upper limit of 95% CI <= 10%||95% CI is for difference in proportion using normal approximation to binomial. Non-inferiority was concluded if the upper boundary of the 95% CI for the Dalteparin - Unfractioned Heparin difference was less than or equal to 10%.|Non-fatal Myocardial Infarction after receiving 48 hours of study medication (Event date - First dose date) and on or before day 30 from baseline. Difference in proportion (Dalteparin-UFH)(%).||5.52|-3.02|
72593836|NCT00435487|144719198|NON_INFERIORITY_OR_EQUIVALENCE|The test of non-inferiority was based on whether the upper limit of the two-sided 95% confidence interval for the treatment group difference was less than or equal to 10%, the non-inferiority margin specified in the protocol.|Difference in proportion|-1.35||||||95.0|-8.62|5.93|||upper limit of 95% CI <= 10%||95% CI is for difference in proportion using normal approximation to binomial. Non-inferiority was concluded if the upper boundary of the 95% CI for the Dalteparin - Unfractioned Heparin difference was less than or equal to 10%.|Death or Non-fatal Myocardial Infarction after receiving 48 hours of study medication (Event date - First dose date) and on or before day 30 from baseline. Difference in proportion (Dalteparin-UFH)(%).||5.93|-8.62|
72593837|NCT00435487|144719199|SUPERIORITY_OR_OTHER||Difference in proportion|1.27||||1||95.0|-1.2|3.73|||Chi-squared||95% CI is for difference in proportion using normal approximation to binomial.|Difference in proportion (Dalteparin-UFH)(%).||3.73|-1.20|1.0000
72593838|NCT00435487|144719200|SUPERIORITY_OR_OTHER||Difference in proportion|-0.05||||1||95.0|-6.05|5.95|||Chi-squared||95% CI is for difference in proportion using normal approximation to binomial.|Difference in proportion (Dalteparin-UFH)(%).||5.95|-6.05|1.0000
72593839|NCT00435487|144719201|SUPERIORITY_OR_OTHER||Difference in proportion|-0.05||||1||95.0|-6.05|5.95|||Chi-squared||95% CI is for difference in proportion using normal approximation to binomial.|Difference in proportion (Dalteparin-UFH)(%).||5.95|-6.05|1.0000
72593840|NCT03301844|144719206|SUPERIORITY|||||||0.071|||||||Chi-squared||||"Patient preference for one of the two treatments at Visit 3 was presented overall in terms of number and percentage of patients preferring the standard or the study treatment.~Patient preference was compared between the standard and the study treatment with a Chi-Square test for equal proportion."|||0.071
72593841|NCT03301844|144719207|OTHER|||||||0.7353|||||||Chi-squared||||"The incidence of all the treatment-emergent systemic Adverse Events recorded in the eCRF was presented overall at patient level; the incidence of all the treatment-emergent ocular Adverse Events recorded in eCRF was presented by treatment group at eye level.~Incidence of treatment-emergent ocular Adverse Events was compared between treatment groups by means of a Chi-square test."|||0.7353
72593842|NCT01267201|144719212|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|92.11|||||TWO_SIDED|90.0|88.23|96.15||||||Natural log transformed AUC (0 - ∞) of methylprednisolone was analyzed using mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% confidence intervals (CIs) for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||96.15|88.23|
72593843|NCT01267201|144719212|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|90.22|||||TWO_SIDED|90.0|86.49|94.11||||||Natural log transformed AUC (0 - ∞) of methylprednisolone was analyzed using mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||94.11|86.49|
72593844|NCT01267201|144719213|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|94.76|||||TWO_SIDED|90.0|88.06|101.98||||||Natural log transformed Cmax of methylprednisolone was analyzed using mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||101.98|88.06|
72593845|NCT01267201|144719213|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|83.89|||||TWO_SIDED|90.0|78.06|90.17||||||Natural log transformed Cmax of methylprednisolone was analyzed using mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||90.17|78.06|
72593846|NCT00501059|144719216|SUPERIORITY_OR_OTHER|||||||0.597|||||||Log Rank|||Primary efficacy analysis of time to the composite endpoint was conducted via a 2-sided log-rank test stratified for treatment, country, and sex. Results would be considered statistically significant and the primary objective of the study will have been met if the 2-sided P value is ≤0.05.||||0.597
72593847|NCT00501059|144719217|SUPERIORITY_OR_OTHER|||||||0.6125|||||||Log Rank|||Statistics for time to the composite endpoint was conducted via a 2-sided log-rank test stratified for treatment, country, and sex. Results would be considered statistically significant if the 2-sided P value is ≤0.05.||||0.6125
72593848|NCT00501059|144719218|SUPERIORITY_OR_OTHER|||||||0.4505|||||||Log Rank|||Statistics for time to non-fatal MI was conducted via a 2-sided log-rank test stratified for treatment, country, and sex. Results would be considered statistically significant if the 2-sided P value is ≤0.05.||||0.4505
72593849|NCT00501059|144719218|SUPERIORITY_OR_OTHER|||||||0.229|||||||Log Rank|||Statistics for time to total MI was conducted via a 2-sided log-rank test stratified for treatment, country, and sex. Results would be considered statistically significant if the 2-sided P value is ≤0.05.||||0.229
72593850|NCT00501059|144719218|SUPERIORITY_OR_OTHER|||||||0.3947|||||||Log Rank|||Statistics for time to total non-fatal stroke was conducted via a 2-sided log-rank test stratified for treatment, country, and sex. Results would be considered statistically significant if the 2-sided P value is ≤0.05.||||0.3947
72593851|NCT00501059|144719218|SUPERIORITY_OR_OTHER|||||||0.5125|||||||Log Rank|||Statistics for time to total stroke was conducted via a 2-sided log-rank test stratified for treatment, country, and sex. Results would be considered statistically significant if the 2-sided P value is ≤0.05.||||0.5125
72593852|NCT00501059|144719219|SUPERIORITY_OR_OTHER|||||||0.9544|||||||Log Rank|||Analysis of time to all-cause mortality was conducted via a 2-sided log-rank test stratified for treatment, country, and sex. Results would be considered statistically significant if the 2-sided P value is ≤0.05.||||0.9544
72414919|NCT01571362|144339958|SUPERIORITY_OR_OTHER||Difference of LS Means|-0.78|STANDARD_ERROR_OF_MEAN|0.235||0.001|TWO_SIDED|95.0|-1.25|-0.32|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariate.|Difference between treatment groups in change from Screening to Week 4.||-0.32|-1.25|0.0010
72414920|NCT01571362|144339958|SUPERIORITY_OR_OTHER||Difference of LS Means|-0.79|STANDARD_ERROR_OF_MEAN|0.271||0.0041|TWO_SIDED|95.0|-1.32|-0.25|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariate.|Difference between treatment groups in change from Screening to Week 8.||-0.25|-1.32|0.0041
72414921|NCT01571362|144339958|SUPERIORITY_OR_OTHER||Difference of LS Means|-1.04|STANDARD_ERROR_OF_MEAN|0.245|<|0.0001|TWO_SIDED|95.0|-1.52|-0.56|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariate.|Difference between treatment groups in change from Screening to Week 12/Early Termination.||-0.56|-1.52|<0.0001
72593853|NCT00501059|144719219|SUPERIORITY_OR_OTHER|||||||0.4422|||||||Log Rank|||Analysis of time to the first occurrence of all cancers excluding non-melanoma skin cancer was conducted via a 2-sided log-rank test stratified for treatment, country, and sex. Results would be considered statistically significant if the 2-sided P value is ≤0.05.||||0.4422
72593854|NCT00501059|144719219|SUPERIORITY_OR_OTHER|||||||0.611|||||||Log Rank|||Analysis of time to the first occurence colon cancer was conducted via a 2-sided log-rank test stratified for treatment, country, and sex. Results would be considered statistically significant if the 2-sided P value is ≤0.05.||||0.611
72593855|NCT00501059|144719220|OTHER||Cox Proportional Hazard|0.99||||0.9459|TWO_SIDED|95.0|0.8|1.24|||Log Rank|||Analysis of incidence of all-cause mortality was conducted via a 2-sided log-rank test. Results would be considered statistically significant if the 2-sided P value is ≤0.05.||1.24|0.80|0.9459
72593856|NCT00501059|144719221|OTHER||Cox Proportional Hazard|0.85||||0.2325|TWO_SIDED|95.0|0.64|1.11|||Log Rank|||Analysis of incidence of MI was conducted via a 2-sided log-rank test. Results would be considered statistically significant if the 2-sided P value is ≤0.05.||1.11|0.64|0.2325
72593857|NCT00501059|144719221|OTHER||Cox Proportional Hazard|1.12||||0.5072||95.0|0.8|1.55|||Log Rank|||Analysis of incidence of stroke was conducted via a 2-sided log-rank test. Results would be considered statistically significant if the 2-sided P value is ≤0.05.||1.55|0.80|0.5072
72593858|NCT00501059|144719221|OTHER||Cox Proportional Hazard|0.97||||0.901||95.0|0.62|1.52|||Log Rank|||Analysis of incidence of cardiovascular death was conducted via a 2-sided log-rank test. Results would be considered statistically significant if the 2-sided P value is ≤0.05.||1.52|0.62|0.9010
72414922|NCT01571362|144339959|SUPERIORITY_OR_OTHER||Difference of LS Means|-0.6|STANDARD_ERROR_OF_MEAN|0.236||0.0115|TWO_SIDED|95.0|-1.06|-0.14|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariate.|Difference between treatment groups in change from Screening to Week 2.||-0.14|-1.06|0.0115
72593859|NCT00501059|144719221|OTHER||Cox Proportional Hazard|1.0||||0.9979|TWO_SIDED|95.0|0.54|1.86|||Log Rank|||Analysis of incidence of UA was conducted via a 2-sided log-rank test. Results would be considered statistically significant if the 2-sided P value is ≤0.05.||1.86|0.54|0.9979
72593860|NCT00501059|144719221|OTHER||Cox Proportional Hazard|0.93||||0.7455|TWO_SIDED|95.0|0.61|1.42|||Log Rank|||Analysis of incidence of TIA was conducted via a 2-sided log-rank test. Results would be considered statistically significant if the 2-sided P value is ≤0.05.||1.42|0.61|0.7455
72593861|NCT00501059|144719223|OTHER||Cox Proportional Hazard|0.96||||0.6038|TWO_SIDED|95.0|0.81|1.13|||Log Rank|||Analysis of incidence of composite outcome of MI, stroke, CV death, UA or TIA was conducted via a 2-sided log-rank test. Results would be considered statistically significant if the 2-sided P value is ≤0.05.||1.13|0.81|0.6038
72593862|NCT00501059|144719223|OTHER||Cox Proportional Hazard|0.95||||0.619|TWO_SIDED|95.0|0.79|1.15|||Log Rank|||Analysis of incidence of composite outcome of MI, stroke or CV death was conducted via a 2-sided log-rank test. Results would be considered statistically significant if the 2-sided P value is ≤0.05.||1.15|0.79|0.6190
72593863|NCT00501059|144719223|OTHER||Cox Proportional Hazard|0.9||||0.4562|TWO_SIDED|95.0|0.67|1.2|||Log Rank|||Analysis of incidence of non-fatal MI was conducted via a 2-sided log-rank test. Results would be considered statistically significant if the 2-sided P value is ≤0.05.||1.20|0.67|0.4562
72593864|NCT00501059|144719224|OTHER||Cox Proportional Hazard|0.81||||0.0756|TWO_SIDED|95.0|0.64|1.02|||Log Rank|||Analysis of incidence of composite outcome of MI, stroke, CV death, UA or TIA was conducted via a 2-sided log-rank test. Results would be considered statistically significant if the 2-sided P value is ≤0.05.||1.02|0.64|0.0756
72593865|NCT00501059|144719224|OTHER||Cox Proportional Hazard|0.79||||0.0661|TWO_SIDED|95.0|0.61|1.02|||Log Rank|||Analysis of incidence of composite outcome of MI, stroke or CV death was conducted via a 2-sided log-rank test. Results would be considered statistically significant if the 2-sided P value is ≤0.05.||1.02|0.61|0.0661
72593866|NCT00501059|144719224|OTHER||Cox Proportional Hazard|0.53||||0.0014|TWO_SIDED|95.0|0.36|0.79|||Log Rank|||Analysis of incidence of MI was conducted via a 2-sided log-rank test. Results would be considered statistically significant if the 2-sided P value is ≤0.05.||0.79|0.36|0.0014
72593867|NCT00501059|144719224|OTHER||Cox Proportional Hazard|0.55||||0.0056|TWO_SIDED|95.0|0.36|0.84|||Log Rank|||Analysis of incidence of non-fatal MI was conducted via a 2-sided log-rank test. Results would be considered statistically significant if the 2-sided P value is ≤0.05.||0.84|0.36|0.0056
72593868|NCT00501059|144719224|OTHER||Cox Proportional Hazard|1.12||||0.6291||95.0|0.71|1.75|||Log Rank|||Analysis of incidence of stroke was conducted via a 2-sided log-rank test. Results would be considered statistically significant if the 2-sided P value is ≤0.05.||1.75|0.71|0.6291
72593869|NCT00501059|144719224|OTHER||Cox Proportional Hazard|1.03||||0.9161|TWO_SIDED|95.0|0.6|1.77|||Log Rank|||Analysis of incidence of CV death was conducted via a 2-sided log-rank test. Results would be considered statistically significant if the 2-sided P value is ≤0.05.||1.77|0.60|0.9161
72593870|NCT00501059|144719224|OTHER||Cox Proportional Hazard|0.75||||0.538||95.0|0.3|1.87|||Log Rank|||Analysis of incidence of UA was conducted via a 2-sided log-rank test. Results would be considered statistically significant if the 2-sided P value is ≤0.05.||1.87|0.30|0.5380
72593871|NCT00501059|144719224|OTHER||Cox Proportional Hazard|1.03||||0.9181|TWO_SIDED|95.0|0.55|1.95|||Log Rank|||Analysis of incidence of TIA was conducted via a 2-sided log-rank test. Results would be considered statistically significant if the 2-sided P value is ≤0.05.||1.95|0.55|0.9181
72593872|NCT00501059|144719224|OTHER||Cox Proportional Hazard|1.1||||0.4796|TWO_SIDED|95.0|0.84|1.45|||Log Rank|||Analysis of incidence of all-cause mortality was conducted via a 2-sided log-rank test. Results would be considered statistically significant if the 2-sided P value is ≤0.05.||1.45|0.84|0.4796
72593873|NCT02719938|144719230|SUPERIORITY|||||||0.415|||||||t-test, 2 sided|||||||0.415
72593874|NCT02719938|144719231|SUPERIORITY|||||||0.521|||||||t-test, 2 sided|||||||0.521
72593875|NCT02719938|144719232|SUPERIORITY|||||||0.409|||||||t-test, 2 sided|||||||0.409
72593876|NCT02719938|144719233|SUPERIORITY|||||||0.019|||||||Chi-squared|||||||0.019
72593877|NCT02719938|144719234|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
72593878|NCT02719938|144719235|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
72593879|NCT02719938|144719236|SUPERIORITY|||||||0.516|||||||t-test, 2 sided|||||||0.516
72593880|NCT00955968|144719242|SUPERIORITY||Hazard Ratio (HR)|0.68||||0.54|TWO_SIDED|95.0|0.19|2.4||5% alpha level and 2-sided test|Log Rank||HR reflects Continue HAART : Stop HAART|||2.40|0.19|0.54
72593881|NCT00955968|144719243|SUPERIORITY||Hazard Ratio (HR)|0.67||||0.66|TWO_SIDED|95.0|0.11|4.01||5% alpha level and 2-sided test|Log Rank||HR reflects Continue HAART : Stop HAART|||4.01|0.11|0.66
72593882|NCT00955968|144719245|SUPERIORITY||Hazard Ratio (HR)|0.52||||0.44|TWO_SIDED|95.0|0.09|2.81||5% alpha level and 2-sided test|Log Rank||HR reflects Continue HAART : Stop HAART|||2.81|0.09|0.44
72593883|NCT00955968|144719246|SUPERIORITY||Hazard Ratio (HR)|0.93||||0.79|TWO_SIDED|95.0|0.54|1.6||5% alpha level and 2-sided test|Log Rank||HR reflects Continue HAART : Stop HAART|||1.60|0.54|0.79
72593884|NCT00955968|144719247|SUPERIORITY||Hazard Ratio (HR)|0.91||||0.71|TWO_SIDED|95.0|0.54|1.52||5% alpha level and 2-sided test|Log Rank||HR reflects Continue HAART : Stop HAART|||1.52|0.54|0.71
72593885|NCT00955968|144719248|SUPERIORITY||Hazard Ratio (HR)|0.58|||<|0.001|TWO_SIDED|95.0|0.42|0.8||5% alpha level and 2-sided test|Log Rank||HR reflects Continue HAART : Stop HAART|||0.80|0.42|<0.001
72593886|NCT00955968|144719249|SUPERIORITY||Hazard Ratio (HR)|0.86||||0.1|TWO_SIDED|95.0|0.72|1.03||5% alpha level and 2-sided test|Log Rank|||||1.03|0.72|0.10
72593887|NCT03559868|144719266|SUPERIORITY||||||<|0.01|||||||ANOVA|Ordinary one-way ANOVA Bartlett's test||For IL10||||<0.01
72593888|NCT01254851|144719311|SUPERIORITY_OR_OTHER||Standardized test statistic (z-score)|0.39||||0.7|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.70
72593889|NCT04231396|144719312|SUPERIORITY||Mean Difference (Final Values)|0.1456||||0.037|TWO_SIDED|95.0|0.012|0.279|||t-test, 1 sided|||The SNR Loss scores computed the means per client and week (1-12), with a smoothing method: isotonic regression (isoreg, via R). The slopes (lsfit, via R) calculated of the smoothed means separately per client, per 7-9 weeks (early training weeks), and per 10-12 weeks (final training weeks). This created slope differences, per client.||.279|.012|.037
72593890|NCT00778102|144719321|SUPERIORITY_OR_OTHER||Difference in Resection Rate|12.3||||0.2707|TWO_SIDED|95.0|-11.0|35.5|||Chi-squared||Confidence interval calculated for difference based on Hauck-Anderson method.|Difference between groups in the collective percentage of participants with R0, R1, or R2.||35.5|-11.0|0.2707
72593891|NCT00778102|144719324|SUPERIORITY_OR_OTHER||Difference in Response Rate|-4.8||||0.7817|TWO_SIDED|95.0|-43.0|33.5|||Chi-squared||Confidence interval calculated for difference based on Hauck-Anderson method.|Difference between groups in the collective percentage of participants with complete or major histopathological response.||33.5|-43.0|0.7817
72593892|NCT00778102|144719331|SUPERIORITY_OR_OTHER||Difference in Response Rate (CR or PR)|18.9||||0.0612|TWO_SIDED|95.0|-2.1|40.0|||Chi-squared||Confidence interval calculated for difference based on Hauck-Anderson method.|Difference between groups in the collective percentage of participants with confirmed best overall response of CR or PR.||40.0|-2.1|0.0612
72593893|NCT04676412|144719399|OTHER|Percent difference and 95% CI were calculated using Miettinen and Nurminen method with Efron's method of tie handling with treatment as a covariate stratified by ECOG performance status (0 versus 1), geographic region of the enrolling site (East Asia versus non-East Asia), and baseline PD-L1 status (1-49% versus ≥50%).|Difference in percentage|-8.4||||0.79262|TWO_SIDED|95.0|-27.4|11.9|||Stratified Miettinen and Nurminen|One-sided p-value for testing. H0: difference in percentage =0 versus H1: difference in percentage \> 0||||11.9|-27.4|0.79262
72593894|NCT04676412|144719402|OTHER|Difference in LS means and 95% CI were calculated using the Constrained longitudinal data analysis (cLDA) model with covariates for treatment by study visit interaction \& stratified by ECOG performance status (0 versus 1) and baseline PD-L1 Status (1% to 49% versus \>=50%).|Difference in Least Square (LS) Means|-0.25||||0.9519|TWO_SIDED|95.0|-8.59|8.09|||cLDA model|Two-sided p-value based on cLDA model with covariates for treatment by study visit interaction; stratified by ECOG and baseline PDL-1.||||8.09|-8.59|0.9519
72593895|NCT04676412|144719403|OTHER|Difference in LS means and 95% CI were calculated using the cLDA model with covariates for treatment by study visit interaction \& stratified by ECOG performance status (0 versus 1) and baseline PD-L1 Status (1% to 49% versus \>=50%).|Difference in LS Means|8.81||||0.0628|TWO_SIDED|95.0|-0.49|18.11|||cLDA model|Two-sided p-value based on cLDA model with covariates for treatment by study visit interaction; stratified by ECOG and baseline PDL-1.||||18.11|-0.49|0.0628
72593896|NCT04676412|144719404|OTHER|Difference in LS means and 95% CI were calculated using the cLDA model with covariates for treatment by study visit interaction \& stratified by ECOG performance status (0 versus 1) and baseline PD-L1 Status (1% to 49% versus \>=50%).|Difference in LS Means|3.59||||0.3298|TWO_SIDED|95.0|-3.7|10.87|||cLDA model|Two-sided p-value based on cLDA model with covariates for treatment by study visit interaction; stratified by ECOG and baseline PDL-1.||||10.87|-3.70|0.3298
72593897|NCT04676412|144719405|OTHER|Difference in LS means and 95% CI were calculated using the cLDA model with covariates for treatment by study visit interaction \& stratified by ECOG performance status (0 versus 1) and baseline PD-L1 Status (1% to 49% versus \>=50%).|Difference in LS Means|-0.28||||0.9594|TWO_SIDED|95.0|-11.32|10.75|||cLDA model|Two-sided p-value based on cLDA model with covariates for treatment by study visit interaction; stratified by ECOG and baseline PDL-1.||||10.75|-11.32|0.9594
72593898|NCT04676412|144719406|OTHER|Difference in LS means and 95% CI were calculated using the cLDA model with covariates for treatment by study visit interaction \& stratified by ECOG performance status (0 versus 1) and baseline PD-L1 Status (1% to 49% versus \>=50%).|Difference in LS Means|-5.53||||0.162|TWO_SIDED|95.0|-13.37|2.31|||cLDA model|Two-sided p-value based on cLDA model with covariates for treatment by study visit interaction; stratified by ECOG and baseline PDL-1.||||2.31|-13.37|0.1620
72593899|NCT04676412|144719407|OTHER|HR and 95% CI were based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG performance status (0 versus 1) and baseline PD-L1 status (1-49% versus ≥50%).|Hazard Ratio (HR)|1.03||||0.9419|TWO_SIDED|95.0|0.47|2.26|||Stratified Log Rank|Two-sided p-value based on log-rank test stratified by ECOG performance status and baseline PD-L1 status.||||2.26|0.47|0.9419
72593900|NCT04676412|144719408|OTHER|HR and 95% CI were calculated using Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG performance status (0 versus 1) and baseline PD-L1 status (1-49% versus ≥50%).|Hazard Ratio (HR)|1.01||||0.9789|TWO_SIDED|95.0|0.43|2.38|||Stratified Log Rank|Two-sided p-value based on log-rank test stratified by ECOG performance status and baseline PD-L1 status.||||2.38|0.43|0.9789
72593901|NCT04676412|144719409|OTHER|HR and 95% CI were calculated using Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG performance status (0 versus 1) and baseline PD-L1 status (1-49% versus ≥50%).|Hazard Ratio (HR)|1.08||||0.8856|TWO_SIDED|95.0|0.36|3.28|||Stratified Log Rank|Two-sided p-value based on log-rank test stratified by ECOG performance status and baseline PD-L1 status.||||3.28|0.36|0.8856
72593902|NCT04676412|144719410|OTHER|HR and 95% CI were calculated using Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG performance status (0 versus 1) and baseline PD-L1 status (1-49% versus ≥50%).|Hazard Ratio (HR)|1.55||||0.3264|TWO_SIDED|95.0|0.64|3.75|||Stratified Log Rank|Two-sided p-value based on log-rank test stratified by ECOG performance status and baseline PD-L1 status.||||3.75|0.64|0.3264
72414923|NCT01571362|144339959|SUPERIORITY_OR_OTHER||Difference of LS Means|-0.66|STANDARD_ERROR_OF_MEAN|0.256||0.0099|TWO_SIDED|95.0|-1.17|-0.16|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariate.|Difference between treatment groups in change from Screening to Week 4.||-0.16|-1.17|0.0099
72414924|NCT01571362|144339959|SUPERIORITY_OR_OTHER||Difference of LS Means|-0.71|STANDARD_ERROR_OF_MEAN|0.307||0.0222|TWO_SIDED|95.0|-1.31|-0.1|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariate.|Difference between treatment groups in change from Screening to Week 8.||-0.10|-1.31|0.0222
72593903|NCT04676412|144719411|OTHER|HR and 95% CI were calculated using Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG performance status (0 versus 1) and baseline PD-L1 status (1-49% versus ≥50%).|Hazard Ratio (HR)|1.31||||0.4068|TWO_SIDED|95.0|0.7|2.46|||Stratified Log Rank|Two-sided p-value based on log-rank test stratified by ECOG performance status and baseline PD-L1 status.||||2.46|0.70|0.4068
72593904|NCT04676412|144719412|OTHER|HR and 95% CI were calculated using Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG performance status (0 versus 1) and baseline PD-L1 status (1-49% versus ≥50%).|Hazard Ratio (HR)|7.81||||0.002|TWO_SIDED|95.0|1.71|35.62|||Stratified Log Rank|Two-sided p-value based on log-rank test stratified by ECOG performance status and baseline PD-L1 status.||||35.62|1.71|0.0020
72593905|NCT04676412|144719413|OTHER|Hazard ratio (HR) and 95% confidence interval (CI) were calculated using Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG performance status (0 versus 1), geographic region of the enrolling site (East Asia versus non-East Asia), and baseline PD-L1 status (1-49% versus ≥50%).|Hazard Ratio (HR)|1.18||||0.71084|TWO_SIDED|95.0|0.61|2.25|||Stratified Log Rank|One-sided p-value based on log-rank test stratified by ECOG performance status, geographic region of enrolling site and baseline PD-L1 status.||||2.25|0.61|0.71084
72593906|NCT04676412|144719414|OTHER||Hazard Ratio (HR)|1.53||||0.8197|TWO_SIDED|95.0|0.61|3.87|||Stratified Log Rank|One-sided p-value based on log-rank test stratified by ECOG performance status, geographic region of enrolling site and baseline PD-L1 status.||HR and 95% CIs were calculated using Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG performance status (0 versus 1), geographic region of the enrolling site (East Asia versus non-East Asia), and baseline PD-L1 status (1-49% versus ≥50%).||3.87|0.61|0.81970
72593907|NCT04765722|144719429|SUPERIORITY||% change relative to placebo|18.0||||0.99|TWO_SIDED|95.0|-46.4|160.1||The model included treatment group, week, the interaction between treatment group and week, and baseline log-transformed 24-hour cough frequency as fixed effects.|Generalized estimating equations|Hypothesis tests were two-sided, a p\<0.05 indicated statistical significance. We made no adjustments for multiple comparisons across outcomes.||The primary outcome was the change from baseline in log-transformed 24-hour cough frequency (coughs/hour) at week 14.||160.1|-46.4|0.99
72593908|NCT05175131|144719443|SUPERIORITY||Mean Difference (Final Values)|1.1||||0.0042|TWO_SIDED|95.0|0.3|1.8|||ANCOVA||Mean difference of Mebeverine+Simethicone combination to Mebeverine. Adjusted least squares mean (difference between Mebeverine+Simethicone combination and Mebeverine) from ANCOVA is presented here|ANCOVA was used for primary end point analysis. The model included the change from baseline of the NRS\_11 score as dependent variable and treatment and site as independent factors, and baseline NRS-11 as covariate.||1.8|0.3|0.0042
72593909|NCT05175131|144719443|SUPERIORITY||Mean Difference (Final Values)|1.6|||<|0.0001|TWO_SIDED|95.0|0.9|2.4|||ANCOVA||Adjusted least squares mean (difference between Mebeverine+Simethicone combination and Mebeverine) from ANCOVA is presented here|Mean difference of Mebeverine+Simethicone combination to Simethicone. ANCOVA was used for primary end point analysis. The model included the change from baseline of the NRS\_11 score as dependent variable and treatment and site as independent factors, and baseline NRS-11 as covariate.||2.4|0.9|<0.0001
72593910|NCT02542293|144719450|SUPERIORITY||Hazard Ratio (HR)|0.71||||0.0808|TWO_SIDED|95.0|0.485|1.045||The 2-sided p-value was calculated using an unstratified log-rank test.|Log Rank||The HR and confidence interval (CI) were calculated using an unstratified Cox proportional hazards model, with ties handled by the Efron approach.|"Global: Durvalumab + Tremelimumab versus (Vs) Global: SoC Chemotherapy~A HR \<1 favors Durvalumab + Tremelimumab combination therapy to be associated with a longer OS than SoC."||1.045|0.485|0.0808
72593911|NCT02542293|144719451|OTHER|The study was not designed or powered to show statistical significance for efficacy endpoints in the China cohort, so all statistical analyses for the China cohort were considered exploratory.|Hazard Ratio (HR)|0.6|||||TWO_SIDED|95.0|0.322|1.109|||||The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for histology (squamous Vs non-squamous), with ties handled by the Efron approach.|"China: Durvalumab + Tremelimumab Vs China: SoC Chemotherapy~A HR \<1 favors Durvalumab + Tremelimumab combination therapy to be associated with a longer OS than SoC."||1.109|0.322|
72593912|NCT02542293|144719452|SUPERIORITY||Hazard Ratio (HR)|0.87|||||TWO_SIDED|95.0|0.629|1.201|||||The HR and CI were calculated using an unstratified Cox proportional hazards model, with ties handled by the Efron approach.|"bTMB ≥16 mut/Mb analysis set: Global: Durvalumab + Tremelimumab Vs Global: SoC Chemotherapy~A HR \<1 favors Durvalumab + Tremelimumab combination therapy to be associated with a longer OS than SoC."||1.201|0.629|
72593913|NCT02542293|144719452|SUPERIORITY||Hazard Ratio (HR)|0.94|||||TWO_SIDED|95.0|0.726|1.213|||||The HR and CI were calculated using an unstratified Cox proportional hazards model, with ties handled by the Efron approach.|"bTMB ≥12 mut/Mb analysis set: Global: Durvalumab + Tremelimumab Vs Global: SoC Chemotherapy~A HR \<1 favors Durvalumab + Tremelimumab combination therapy to be associated with a longer OS than SoC."||1.213|0.726|
72593914|NCT02542293|144719452|SUPERIORITY||Hazard Ratio (HR)|1.07|||||TWO_SIDED|95.0|0.786|1.464|||||The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for smoking status (never smoker Vs ever smoker) and histology (squamous Vs non-squamous), with ties handled by the Efron approach.|"PD-L1 negative analysis set:~Global: Durvalumab + Tremelimumab Vs Global: SoC Chemotherapy~A HR \<1 favors Durvalumab + Tremelimumab combination therapy to be associated with a longer OS than SoC."||1.464|0.786|
72414925|NCT01571362|144339959|SUPERIORITY_OR_OTHER||Difference of LS Means|-1.02|STANDARD_ERROR_OF_MEAN|0.264||0.0001|TWO_SIDED|95.0|-1.54|-0.5|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariate.|Difference between treatment groups in change from Screening to Week 12/ Early Termination.||-0.50|-1.54|0.0001
72593915|NCT02542293|144719452|SUPERIORITY||Hazard Ratio (HR)|1.04|||||TWO_SIDED|95.0|0.835|1.302|||||The HR and CI were calculated using an unstratified Cox proportional hazards model, with ties handled by the Efron approach.|"bTMB \<20 mut/Mb analysis set: Global: Durvalumab + Tremelimumab Vs Global: SoC Chemotherapy~A HR \<1 favors Durvalumab + Tremelimumab combination therapy to be associated with a longer OS than SoC."||1.302|0.835|
72593916|NCT02542293|144719452|SUPERIORITY||Hazard Ratio (HR)|1.01|||||TWO_SIDED|95.0|0.758|1.353|||||The HR and CI were calculated using an unstratified Cox proportional hazards model, with ties handled by the Efron approach.|"bTMB non-evaluable analysis set: Global: Durvalumab + Tremelimumab Vs Global: SoC Chemotherapy~A HR \<1 favors Durvalumab + Tremelimumab combination therapy to be associated with a longer OS than SoC."||1.353|0.758|
72593917|NCT02542293|144719452|SUPERIORITY||Hazard Ratio (HR)|0.57|||||TWO_SIDED|95.0|0.309|1.008|||||The HR and CI were calculated using an unstratified Cox proportional hazards model, with ties handled by the Efron approach.|"tTMB ≥14 mut/Mb analysis set: Global: Durvalumab + Tremelimumab Vs Global: SoC Chemotherapy~A HR \<1 favors Durvalumab + Tremelimumab combination therapy to be associated with a longer OS than SoC."||1.008|0.309|
72593918|NCT02542293|144719452|SUPERIORITY||Hazard Ratio (HR)|0.87|||||TWO_SIDED|95.0|0.56|1.35|||||The HR and CI were calculated using an unstratified Cox proportional hazards model, with ties handled by the Efron approach.|"tTMB ≥12 mut/Mb analysis set: Global: Durvalumab + Tremelimumab Vs Global: SoC Chemotherapy~A HR \<1 favors Durvalumab + Tremelimumab combination therapy to be associated with a longer OS than SoC."||1.350|0.560|
72593919|NCT02542293|144719452|SUPERIORITY||Hazard Ratio (HR)|0.88|||||TWO_SIDED|95.0|0.614|1.251|||||The HR and CI were calculated using an unstratified Cox proportional hazards model, with ties handled by the Efron approach.|"tTMB ≥10 mut/Mb analysis set: Global: Durvalumab + Tremelimumab Vs Global: SoC Chemotherapy~A HR \<1 favors Durvalumab + Tremelimumab combination therapy to be associated with a longer OS than SoC."||1.251|0.614|
72593920|NCT02542293|144719452|SUPERIORITY||Hazard Ratio (HR)|0.78|||||TWO_SIDED|95.0|0.564|1.08|||||The HR and CI were calculated using an unstratified Cox proportional hazards model, with ties handled by the Efron approach.|"tTMB ≥8 mut/Mb analysis set: Global: Durvalumab + Tremelimumab Vs Global: SoC Chemotherapy~A HR \<1 favors Durvalumab + Tremelimumab combination therapy to be associated with a longer OS than SoC."||1.080|0.564|
72593921|NCT02542293|144719453|SUPERIORITY||Hazard Ratio (HR)|1.02|||||TWO_SIDED|95.0|0.871|1.186|||||The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for PD-L1 status (≥25% Vs \<25%), smoking status (never smoker Vs ever smoker) and histology (squamous Vs non-squamous), with ties handled by Efron approach.|"FAS:~Global: Durvalumab + Tremelimumab Vs Global: SoC Chemotherapy~A HR \<1 favors Durvalumab + Tremelimumab combination therapy to be associated with a longer OS than SoC."||1.186|0.871|
72593922|NCT02542293|144719453|OTHER|The study was not designed or powered to show statistical significance for efficacy endpoints in the China cohort, so all statistical analyses for the China cohort were considered exploratory.|Hazard Ratio (HR)|0.7|||||TWO_SIDED|95.0|0.48|1.018|||||The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for PD-L1 status (\>= 25% Vs \< 25 and histology (squamous Vs non-squamous), with ties handled by the Efron approach.|"FAS:~China: Durvalumab + Tremelimumab Vs China: SoC Chemotherapy~A HR \<1 favors Durvalumab + Tremelimumab combination therapy to be associated with a longer OS than SoC."||1.018|0.480|
72593923|NCT02542293|144719453|SUPERIORITY||Hazard Ratio (HR)|0.84|||||TWO_SIDED|95.0|0.654|1.078|||||The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for smoking status (never smoker Vs ever smoker) and histology (squamous Vs non-squamous), with ties handled by the Efron approach.|"PD-L1 TC ≥25% analysis set:~Global: Durvalumab + Tremelimumab Vs Global: SoC Chemotherapy~A HR \<1 favors Durvalumab + Tremelimumab combination therapy to be associated with a longer OS than SoC."||1.078|0.654|
72593924|NCT02542293|144719453|OTHER|The study was not designed or powered to show statistical significance for efficacy endpoints in the China cohort, so all statistical analyses for the China cohort were considered exploratory.|Hazard Ratio (HR)|0.56|||||TWO_SIDED|95.0|0.289|1.065|||||The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for histology (squamous Vs non-squamous), with ties handled by the Efron approach.|"PD-L1 TC ≥ 25% analysis set:~China: Durvalumab + Tremelimumab Vs China: SoC Chemotherapy~A HR \<1 favors Durvalumab + Tremelimumab combination therapy to be associated with a longer OS than SoC."||1.065|0.289|
72593925|NCT02542293|144719453|SUPERIORITY||Hazard Ratio (HR)|0.8|||||TWO_SIDED|95.0|0.587|1.081|||||The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for smoking status (never smoker Vs ever smoker) and histology (squamous Vs non-squamous), with ties handled by the Efron approach.|"PD-L1 TC ≥50% analysis set:~Global: Durvalumab + Tremelimumab Vs Global: SoC Chemotherapy~A HR \<1 favors Durvalumab + Tremelimumab combination therapy to be associated with a longer OS than SoC."||1.081|0.587|
72593926|NCT02542293|144719453|OTHER|The study was not designed or powered to show statistical significance for efficacy endpoints in the China cohort, so all statistical analyses for the China cohort were considered exploratory.|Hazard Ratio (HR)|0.47|||||TWO_SIDED|95.0|0.222|0.955|||||The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for histology (squamous Vs non-squamous), with ties handled by the Efron approach.|"PD-L1 TC ≥50% analysis set:~China: Durvalumab + Tremelimumab Vs China: SoC Chemotherapy~A HR \<1 favors Durvalumab + Tremelimumab combination therapy to be associated with a longer OS than SoC."||0.955|0.222|
72593927|NCT02542293|144719454|SUPERIORITY||Hazard Ratio (HR)|0.77|||||TWO_SIDED|95.0|0.514|1.146|||||The HR and CI interval were calculated using an unstratified Cox proportional hazards model, with ties handled by the Efron approach.|"bTMB ≥20 mut/Mb analysis set: Global: Durvalumab + Tremelimumab Vs Global: SoC Chemotherapy~A HR \<1 favors Durvalumab + Tremelimumab combination therapy to be associated with a longer PFS than SoC."||1.146|0.514|
72414926|NCT01571362|144339960|SUPERIORITY_OR_OTHER||Difference of LS Means|-0.66|STANDARD_ERROR_OF_MEAN|0.218||0.0025|TWO_SIDED|95.0|-1.09|-0.24|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariate.|Difference between treatment groups in change from Screening to Week 2.||-0.24|-1.09|0.0025
72593928|NCT02542293|144719454|SUPERIORITY||Hazard Ratio (HR)|0.86|||||TWO_SIDED|95.0|0.623|1.189|||||The HR and CI interval were calculated using an unstratified Cox proportional hazards model, with ties handled by the Efron approach.|"bTMB ≥16 mut/Mb analysis set: Global: Durvalumab + Tremelimumab Vs Global: SoC Chemotherapy~A HR \<1 favors Durvalumab + Tremelimumab combination therapy to be associated with a longer PFS than SoC."||1.189|0.623|
72593929|NCT02542293|144719454|SUPERIORITY||Hazard Ratio (HR)|0.92|||||TWO_SIDED|95.0|0.714|1.193|||||The HR and CI interval were calculated using an unstratified Cox proportional hazards model, with ties handled by the Efron approach.|"bTMB ≥12 mut/Mb analysis set: Global: Durvalumab + Tremelimumab Vs Global: SoC Chemotherapy~A HR \<1 favors Durvalumab + Tremelimumab combination therapy to be associated with a longer PFS than SoC."||1.193|0.714|
72593930|NCT02542293|144719454|SUPERIORITY||Hazard Ratio (HR)|0.46|||||TWO_SIDED|95.0|0.258|0.818|||||The HR and CI were calculated using an unstratified Cox proportional hazards model, with ties handled by the Efron approach.|"tTMB ≥14 mut/Mb analysis set: Global: Durvalumab + Tremelimumab Vs Global: SoC Chemotherapy~A HR \<1 favors Durvalumab + Tremelimumab combination therapy to be associated with a longer PFS than SoC."||0.818|0.258|
72593931|NCT02542293|144719454|SUPERIORITY||Hazard Ratio (HR)|0.8|||||TWO_SIDED|95.0|0.524|1.228|||||The HR and CI were calculated using an unstratified Cox proportional hazards model, with ties handled by the Efron approach.|"tTMB ≥12 mut/Mb analysis set: Global: Durvalumab + Tremelimumab Vs Global: SoC Chemotherapy~A HR \<1 favors Durvalumab + Tremelimumab combination therapy to be associated with a longer PFS than SoC."||1.228|0.524|
72593932|NCT02542293|144719454|SUPERIORITY||Hazard Ratio (HR)|0.83|||||TWO_SIDED|95.0|0.585|1.177|||||The HR and CI were calculated using an unstratified Cox proportional hazards model, with ties handled by the Efron approach.|"tTMB ≥10 mut/Mb analysis set: Global: Durvalumab + Tremelimumab Vs Global: SoC Chemotherapy~A HR \<1 favors Durvalumab + Tremelimumab combination therapy to be associated with a longer PFS than SoC."||1.177|0.585|
72593933|NCT02542293|144719454|SUPERIORITY||Hazard Ratio (HR)|0.74|||||TWO_SIDED|95.0|0.534|1.017|||||The HR and CI were calculated using an unstratified Cox proportional hazards model, with ties handled by the Efron approach.|"tTMB ≥8 mut/Mb analysis set: Global: Durvalumab + Tremelimumab Vs Global: SoC Chemotherapy~A HR \<1 favors Durvalumab + Tremelimumab combination therapy to be associated with a longer PFS than SoC."||1.017|0.534|
72593934|NCT02542293|144719455|SUPERIORITY||Hazard Ratio (HR)|1.11|||||TWO_SIDED|95.0|0.81|1.517|||||The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for smoking status (never smoker Vs ever smoker) and histology (squamous Vs non-squamous), with ties handled by the Efron approach.|"PD-L1-negative analysis set:~Global: Durvalumab + Tremelimumab Vs Global: SoC Chemotherapy~A HR \<1 favors Durvalumab + Tremelimumab combination therapy to be associated with a longer PFS than SoC."||1.517|0.810|
72593935|NCT02542293|144719455|OTHER|The study was not designed or powered to show statistical significance for efficacy endpoints in the China cohort, so all statistical analyses for the China cohort were considered exploratory.|Hazard Ratio (HR)|1.13|||||TWO_SIDED|95.0|0.592|2.141|||||The HR and CI interval were calculated using an stratified Cox proportional hazards model, adjusting histology (squamous Vs non-squamous), with ties handled by the Efron approach.|"PD-L1-negative analysis set:~China: Durvalumab + Tremelimumab Vs China: SoC Chemotherapy~A HR \<1 favors Durvalumab + Tremelimumab combination therapy to be associated with a longer PFS than SoC."||2.141|0.592|
72593936|NCT02542293|144719455|SUPERIORITY||Hazard Ratio (HR)|1.08|||||TWO_SIDED|95.0|0.924|1.253|||||The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for PD-L1 status (≥25% Vs \<25%), smoking status (never smoker Vs ever smoker) and histology (squamous Vs non-squamous), with ties handled by Efron approach.|"FAS:~Global: Durvalumab + Tremelimumab Vs Global: SoC Chemotherapy~A HR \<1 favors Durvalumab + Tremelimumab combination therapy to be associated with a longer PFS than SoC."||1.253|0.924|
72593937|NCT02542293|144719455|OTHER|The study was not designed or powered to show statistical significance for efficacy endpoints in the China cohort, so all statistical analyses for the China cohort were considered exploratory.|Hazard Ratio (HR)|0.95|||||TWO_SIDED|95.0|0.655|1.362|||||The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for PD-L1 status (≥ 25% Vs \< 25%) and histology (squamous Vs non-squamous), with ties handled by the Efron approach.|"FAS:~China: Durvalumab + Tremelimumab Vs China: SoC Chemotherapy~A HR \<1 favors Durvalumab + Tremelimumab combination therapy to be associated with a longer PFS than SoC."||1.362|0.655|
72593938|NCT02542293|144719455|SUPERIORITY||Hazard Ratio (HR)|0.8|||||TWO_SIDED|95.0|0.621|1.024|||||The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for smoking status (never smoker Vs ever smoker) and histology (squamous Vs non-squamous), with ties handled by the Efron approach.|"PD-L1 TC ≥25% analysis set:~Global: Durvalumab + Tremelimumab Vs Global: SoC Chemotherapy~A HR \<1 favors Durvalumab + Tremelimumab combination therapy to be associated with a longer PFS than SoC."||1.024|0.621|
72593939|NCT02542293|144719455|OTHER|The study was not designed or powered to show statistical significance for efficacy endpoints in the China cohort, so all statistical analyses for the China cohort were considered exploratory.|Hazard Ratio (HR)|0.72|||||TWO_SIDED|95.0|0.389|1.317|||||The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for histology (squamous Vs non-squamous), with ties handled by the Efron approach.|"PD-L1 TC ≥ 25% analysis set:~China: Durvalumab + Tremelimumab Vs China: SoC Chemotherapy~A HR \<1 favors Durvalumab + Tremelimumab combination therapy to be associated with a longer PFS than SoC."||1.317|0.389|
72593940|NCT02542293|144719455|SUPERIORITY||Hazard Ratio (HR)|0.74|||||TWO_SIDED|95.0|0.542|1.01|||||The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for smoking status (never smoker Vs ever smoker) and histology (squamous Vs non-squamous), with ties handled by the Efron approach.|"PD-L1 TC ≥50% analysis set:~Global: Durvalumab + Tremelimumab Vs Global: SoC Chemotherapy~A HR \<1 favors Durvalumab + Tremelimumab combination therapy to be associated with a longer PFS than SoC."||1.010|0.542|
72593941|NCT02542293|144719455|OTHER|The study was not designed or powered to show statistical significance for efficacy endpoints in the China cohort, so all statistical analyses for the China cohort were considered exploratory.|Hazard Ratio (HR)|0.65|||||TWO_SIDED|95.0|0.335|1.251|||||The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for histology (squamous Vs non-squamous), with ties handled by the Efron approach.|"PD-L1 TC ≥50% analysis set:~China: Durvalumab + Tremelimumab Vs China: SoC Chemotherapy~A HR \<1 favors Durvalumab + Tremelimumab combination therapy to be associated with a longer PFS than SoC."||1.251|0.335|
72593942|NCT02542293|144719456|SUPERIORITY||Odds Ratio (OR)|0.5|||||TWO_SIDED|95.0|0.236|1.03||||||"bTMB ≥20 mut/Mb analysis set: Global: Durvalumab + Tremelimumab Vs Global: SoC Chemotherapy~An odds ratio \>1 favors Durvalumab + Tremelimumab combination therapy over SoC."||1.030|0.236|
72593943|NCT02542293|144719456|SUPERIORITY||Odds Ratio (OR)|0.53|||||TWO_SIDED|95.0|0.288|0.968||||||"bTMB ≥16 mut/Mb analysis set: Global: Durvalumab + Tremelimumab Vs Global: SoC Chemotherapy~An odds ratio \>1 favors Durvalumab + Tremelimumab combination therapy over SoC."||0.968|0.288|
72593944|NCT02542293|144719456|SUPERIORITY||Odds Ratio (OR)|0.55|||||TWO_SIDED|95.0|0.336|0.908||||||"bTMB ≥12 mut/Mb analysis set: Global: Durvalumab + Tremelimumab Vs Global: SoC Chemotherapy~An odds ratio \>1 favors Durvalumab + Tremelimumab combination therapy over SoC."||0.908|0.336|
72593945|NCT02542293|144719456|SUPERIORITY||Odds Ratio (OR)|1.96|||||TWO_SIDED|95.0|0.752|5.234||||||"tTMB ≥14 mut/Mb analysis set: Global: Durvalumab + Tremelimumab Vs Global: SoC Chemotherapy~An odds ratio \>1 favors Durvalumab + Tremelimumab combination therapy over SoC."||5.234|0.752|
72593946|NCT02542293|144719456|SUPERIORITY||Odds Ratio (OR)|1.03|||||TWO_SIDED|95.0|0.482|2.214||||||"tTMB ≥12 mut/Mb analysis set: Global: Durvalumab + Tremelimumab Vs Global: SoC Chemotherapy~An odds ratio \>1 favors Durvalumab + Tremelimumab combination therapy over SoC."||2.214|0.482|
72593947|NCT02542293|144719456|SUPERIORITY||Odds Ratio (OR)|0.82|||||TWO_SIDED|95.0|0.43|1.548||||||"tTMB ≥10 mut/Mb analysis set: Global: Durvalumab + Tremelimumab Vs Global: SoC Chemotherapy~An odds ratio \>1 favors Durvalumab + Tremelimumab combination therapy over SoC."||1.548|0.430|
72593948|NCT02542293|144719456|SUPERIORITY||Odds Ratio (OR)|0.83|||||TWO_SIDED|95.0|0.456|1.486||||||"tTMB ≥8 mut/Mb analysis set: Global: Durvalumab + Tremelimumab Vs Global: SoC Chemotherapy~An odds ratio \>1 favors Durvalumab + Tremelimumab combination therapy over SoC."||1.486|0.456|
72593949|NCT02542293|144719457|SUPERIORITY||Odds Ratio (OR)|0.47|||||TWO_SIDED|95.0|0.245|0.869|||||The analysis was performed using logistic regression, adjusting for smoking status (never smoker Vs ever smoker) and histology (squamous Vs non-squamous), with 95% CI calculated by profile likelihood.|"PD-L1-negative analysis set:~Global: Durvalumab + Tremelimumab Vs Global: SoC Chemotherapy~An odds ratio \>1 favors Durvalumab + Tremelimumab combination therapy over SoC."||0.869|0.245|
72593950|NCT02542293|144719457|OTHER|The study was not designed or powered to show statistical significance for efficacy endpoints in the China cohort, so all statistical analyses for the China cohort were considered exploratory.|Odds Ratio (OR)|0.42|||||TWO_SIDED|95.0|0.124|1.337|||Binomial exact test|||"PD-L1-negative analysis set:~China: Durvalumab + Tremelimumab Vs China: SoC Chemotherapy~An odds ratio \>1 favors Durvalumab + Tremelimumab combination therapy over SoC."||1.337|0.124|
72593951|NCT02542293|144719457|SUPERIORITY||Odds Ratio (OR)|0.48|||||TWO_SIDED|95.0|0.356|0.647|||||The analysis was performed using logistic regression adjusting for PD-L1 status (≥25% Vs \<25%), smoking status (never smoker Vs ever smoker) and histology (squamous Vs non-squamous), with 95% CI calculated by profile likelihood.|"FAS:~Global: Durvalumab + Tremelimumab Vs Global: SoC Chemotherapy~An odds ratio \>1 favors Durvalumab + Tremelimumab combination therapy over SoC."||0.647|0.356|
72593952|NCT02542293|144719457|OTHER|The study was not designed or powered to show statistical significance for efficacy endpoints in the China cohort, so all statistical analyses for the China cohort were considered exploratory.|Odds Ratio (OR)|0.87|||||TWO_SIDED|95.0|0.45|1.66|||||The analysis was performed using logistic regression, adjusting for PD-L1 status (\>= 25% Vs \< 25%), smoking status (never smoker Va ever smoker) and histology (squamous Vs non-squamous), with 95% CI calculated by profile likelihood.|"FAS:~China: Durvalumab + Tremelimumab Vs China: SoC Chemotherapy~An odds ratio \>1 favors Durvalumab + Tremelimumab combination therapy over SoC."||1.660|0.450|
72593953|NCT02542293|144719457|SUPERIORITY||Odds Ratio (OR)|0.69|||||TWO_SIDED|95.0|0.443|1.079|||||The analysis was performed using logistic regression, adjusting for smoking status (never smoker Vs ever smoker) and histology (squamous Vs non-squamous), with 95% CI calculated by profile likelihood.|"PD-L1 TC ≥25% analysis set:~Global: Durvalumab + Tremelimumab Vs Global: SoC Chemotherapy~An odds ratio \>1 favors Durvalumab + Tremelimumab combination therapy over SoC."||1.079|0.443|
72414927|NCT01571362|144339960|SUPERIORITY_OR_OTHER||Difference of LS Means|-0.77|STANDARD_ERROR_OF_MEAN|0.235||0.0012|TWO_SIDED|95.0|-1.23|-0.31|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariate.|Difference between treatment groups in change from Screening to Week 4.||-0.31|-1.23|0.0012
72414928|NCT01571362|144339960|SUPERIORITY_OR_OTHER||Difference of LS Means|-0.73|STANDARD_ERROR_OF_MEAN|0.272||0.0078|TWO_SIDED|95.0|-1.27|-0.19|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariate.|Difference between treatment groups in change from Screening to Week 8.||-0.19|-1.27|0.0078
72593954|NCT02542293|144719457|OTHER|The study was not designed or powered to show statistical significance for efficacy endpoints in the China cohort, so all statistical analyses for the China cohort were considered exploratory.|Odds Ratio (OR)|1.78|||||TWO_SIDED|95.0|0.658|4.919|||||The analysis was performed using logistic regression, adjusting for PD-L1 status (\>= 25% Vs \< 25%), smoking status (never smoker Va ever smoker) and histology (squamous Vs non-squamous), with 95% CI calculated by profile likelihood.|"PD-L1 TC ≥ 25% analysis set:~China: Durvalumab + Tremelimumab Vs China: SoC Chemotherapy~An odds ratio \>1 favors Durvalumab + Tremelimumab combination therapy over SoC."||4.919|0.658|
72593955|NCT02542293|144719457|SUPERIORITY||Odds Ratio (OR)|0.76|||||TWO_SIDED|95.0|0.449|1.291|||||The analysis was performed using logistic regression, adjusting for smoking status (never smoker Vs ever smoker) and histology (squamous Vs non-squamous), with 95% CI calculated by profile likelihood.|"PD-L1 TC ≥50% analysis set:~Global: Durvalumab + Tremelimumab Vs Global: SoC Chemotherapy~An odds ratio \>1 favors Durvalumab + Tremelimumab combination therapy over SoC."||1.291|0.449|
72593956|NCT02542293|144719457|OTHER|The study was not designed or powered to show statistical significance for efficacy endpoints in the China cohort, so all statistical analyses for the China cohort were considered exploratory.|Odds Ratio (OR)|1.73|||||TWO_SIDED|95.0|0.585|5.27|||||The analysis was performed using logistic regression, adjusting for PD-L1 status (\>= 25% Vs \< 25%), smoking status (never smoker Va ever smoker) and histology (squamous Vs non-squamous), with 95% CI calculated by profile likelihood.|"PD-L1 TC ≥50% analysis set:~China: Durvalumab + Tremelimumab Vs China: SoC Chemotherapy~An odds ratio \>1 favors Durvalumab + Tremelimumab combination therapy over SoC."||5.270|0.585|
72593957|NCT02542293|144719458|SUPERIORITY||Hazard Ratio (HR)|0.25|||||TWO_SIDED|95.0|0.113|0.532|||||The HR and CI were calculated using an unstratified Cox proportional hazards model, with ties handled by the Efron approach.|"bTMB ≥20 mut/Mb analysis set: Global: Durvalumab + Tremelimumab Vs Global: SoC Chemotherapy~A HR \<1 favors Durvalumab + Tremelimumab combination therapy to be associated with a longer DoR than SoC."||0.532|0.113|
72593958|NCT02542293|144719458|SUPERIORITY||Hazard Ratio (HR)|0.36|||||TWO_SIDED|95.0|0.196|0.639|||||The HR and CI were calculated using an unstratified Cox proportional hazards model, with ties handled by the Efron approach.|"bTMB ≥16 mut/Mb analysis set: Global: Durvalumab + Tremelimumab Vs Global: SoC Chemotherapy~A HR \<1 favors Durvalumab + Tremelimumab combination therapy to be associated with a longer DoR than SoC."||0.639|0.196|
72593959|NCT02542293|144719458|SUPERIORITY||Hazard Ratio (HR)|0.38|||||TWO_SIDED|95.0|0.233|0.611|||||The HR and CI were calculated using an unstratified Cox proportional hazards model, with ties handled by the Efron approach.|"bTMB ≥12 mut/Mb analysis set: Global: Durvalumab + Tremelimumab Vs Global: SoC Chemotherapy~A HR \<1 favors Durvalumab + Tremelimumab combination therapy to be associated with a longer DoR than SoC."||0.611|0.233|
72593960|NCT02542293|144719459|SUPERIORITY||Hazard Ratio (HR)|0.41|||||TWO_SIDED|95.0|0.199|0.787|||||The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for smoking status (never smoker Vs ever smoker) and histology (squamous Vs non-squamous), with ties handled by the Efron approach.|"PD-L1-negative analysis set:~Global: Durvalumab + Tremelimumab Vs Global: SoC Chemotherapy~A HR \<1 favors Durvalumab + Tremelimumab combination therapy to be associated with a longer DoR than SoC."||0.787|0.199|
72593961|NCT02542293|144719459|OTHER|The study was not designed or powered to show statistical significance for efficacy endpoints in the China cohort, so all statistical analyses for the China cohort were considered exploratory.|Hazard Ratio (HR)|0.79|||||TWO_SIDED|95.0|0.183|2.86|||||The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for histology (squamous Vs non-squamous), with ties handled by the Efron approach.|"PD-L1-negative analysis set:~China: Durvalumab + Tremelimumab Vs China: SoC Chemotherapy~A HR \<1 favors Durvalumab + Tremelimumab combination therapy to be associated with a longer DoR than SoC."||2.860|0.183|
72593962|NCT02542293|144719459|SUPERIORITY||Hazard Ratio (HR)|0.44|||||TWO_SIDED|95.0|0.324|0.588|||||The HR and CI were calculated using an unstratified Cox proportional hazards model, with ties handled by the Efron approach.|"FAS:~Global: Durvalumab + Tremelimumab Vs Global: SoC Chemotherapy~A HR \<1 favors Durvalumab + Tremelimumab combination therapy to be associated with a longer DoR than SoC."||0.588|0.324|
72593963|NCT02542293|144719459|OTHER|The study was not designed or powered to show statistical significance for efficacy endpoints in the China cohort, so all statistical analyses for the China cohort were considered exploratory.|Hazard Ratio (HR)|0.39|||||TWO_SIDED|95.0|0.193|0.761|||||The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for PD-L1 status (\>= 25% Vs \< 25%) and histology (squamous Vs non-squamous), with ties handled by the Efron approach.|"FAS:~China: Durvalumab + Tremelimumab Vs China: SoC Chemotherapy~A HR \<1 favors Durvalumab + Tremelimumab combination therapy to be associated with a longer DoR than SoC."||0.761|0.193|
72593964|NCT02542293|144719462|SUPERIORITY||Hazard Ratio (HR)|0.72|||||TWO_SIDED|95.0|0.494|1.058|||||The HR and CI were calculated using an unstratified Cox proportional hazards model, with ties handled by the Efron approach.|"bTMB ≥20 mut/Mb analysis set: Global: Durvalumab + Tremelimumab Vs Global: SoC Chemotherapy~A HR \<1 favors Durvalumab + Tremelimumab to be associated with a longer time to second progression than SoC."||1.058|0.494|
72414929|NCT01571362|144339960|SUPERIORITY_OR_OTHER||Difference of LS Means|-1.04|STANDARD_ERROR_OF_MEAN|0.243|<|0.0001|TWO_SIDED|95.0|-1.52|-0.56|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariate.|Difference between treatment groups in change from Screening to Week 12/Early Termination.||-0.56|-1.52|<0.0001
72414930|NCT01571362|144339961|SUPERIORITY_OR_OTHER||Difference of LS Means|-0.41|STANDARD_ERROR_OF_MEAN|0.228||0.0727|TWO_SIDED|95.0|-0.86|0.04|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariate.|Difference between treatment groups in change from Screening to Week 2.||0.04|-0.86|0.0727
72414931|NCT01571362|144339961|SUPERIORITY_OR_OTHER||Difference of LS Means|-0.47|STANDARD_ERROR_OF_MEAN|0.238||0.0501|TWO_SIDED|95.0|-0.94|0.0|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariate.|Difference between treatment groups in change from Screening to Week 4.||0.00|-0.94|0.0501
72593965|NCT02542293|144719462|SUPERIORITY||Hazard Ratio (HR)|0.84|||||TWO_SIDED|95.0|0.607|1.151|||||The HR and CI were calculated using an unstratified Cox proportional hazards model, with ties handled by the Efron approach.|"bTMB ≥16 mut/Mb analysis set: Global: Durvalumab + Tremelimumab Vs Global: SoC Chemotherapy~A HR \<1 favors Durvalumab + Tremelimumab to be associated with a longer time to second progression than SoC."||1.151|0.607|
72593966|NCT02542293|144719462|SUPERIORITY||Hazard Ratio (HR)|0.89|||||TWO_SIDED|95.0|0.689|1.146|||||The HR and CI were calculated using an unstratified Cox proportional hazards model, with ties handled by the Efron approach.|"bTMB ≥12 mut/Mb analysis set: Global: Durvalumab + Tremelimumab Vs Global: SoC Chemotherapy~A HR \<1 favors Durvalumab + Tremelimumab to be associated with a longer time to second progression than SoC."||1.146|0.689|
72593967|NCT02542293|144719463|SUPERIORITY||Hazard Ratio (HR)|1.02|||||TWO_SIDED|95.0|0.748|1.388|||||The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for smoking status (never smoker Vs ever smoker) and histology (squamous Vs non-squamous), with ties handled by the Efron approach.|"PD-L1-negative analysis set:~Global: Durvalumab + Tremelimumab Vs Global: SoC Chemotherapy~A HR \<1 favors Durvalumab + Tremelimumab to be associated with a longer time to second progression than SoC."||1.388|0.748|
72593968|NCT02542293|144719463|OTHER|The study was not designed or powered to show statistical significance for efficacy endpoints in the China cohort, so all statistical analyses for the China cohort were considered exploratory.|Hazard Ratio (HR)|0.67|||||TWO_SIDED|95.0|0.36|1.219|||||The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for histology (squamous Vs non-squamous), with ties handled by the Efron approach.|"PD-L1-negative analysis set:~China: Durvalumab + Tremelimumab Vs China: SoC Chemotherapy~A HR \<1 favors Durvalumab + Tremelimumab to be associated with a longer time to second progression than SoC."||1.219|0.360|
72593969|NCT02542293|144719463|SUPERIORITY||Hazard Ratio (HR)|0.98|||||TWO_SIDED|95.0|0.845|1.147|||||The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for PD-L1 status (\>= 25% Vs \< 25%), smoking status (never smoker Vs ever smoker) and histology (squamous Vs non-squamous), with ties handled by Efron approach.|"FAS:~Global: Durvalumab + Tremelimumab Vs Global: SoC Chemotherapy~A HR \<1 favors Durvalumab + Tremelimumab to be associated with a longer time to second progression than SoC."||1.147|0.845|
72593970|NCT02542293|144719463|OTHER|The study was not designed or powered to show statistical significance for efficacy endpoints in the China cohort, so all statistical analyses for the China cohort were considered exploratory.|Hazard Ratio (HR)|0.71|||||TWO_SIDED|95.0|0.492|1.03|||||The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for histology (squamous Vs non-squamous), with ties handled by the Efron approach.|"FAS:~China: Durvalumab + Tremelimumab Vs China: SoC Chemotherapy~A HR \<1 favors Durvalumab + Tremelimumab to be associated with a longer time to second progression than SoC."||1.030|0.492|
72593971|NCT00480493|144719472|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.46|STANDARD_ERROR_OF_MEAN|3.36||0.468|TWO_SIDED|95.0|-4.32|9.24|||t-test, 2 sided||Confidence scores were also compared using random-effect, mixed regression models to determine whether changes over time differed significantly between groups.|A 2 sided t-test was used to determine if the change in Confidence score was significantly different between the groups.||9.24|-4.32|0.468
72593972|NCT00480493|144719473|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.82|STANDARD_ERROR_OF_MEAN|10.05||0.634|TWO_SIDED|95.0|-15.47|25.11|||t-test, 2 sided||Concern scores were also compared using random-effect, mixed regression models to determine whether changes over time differed significantly between groups.|A 2 sided t-test was used to determine if there were significant differences in Concern between the two groups at 12 months.||25.11|-15.47|0.634
72593973|NCT00480493|144719474|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.48|STANDARD_ERROR_OF_MEAN|3.12||0.43|TWO_SIDED|95.0|-8.76|3.8|||t-test, 2 sided||We also used a random-effect, mixed regression models to look for between group changes over time.|The difference in the Worry score at 12 months was compared between the groups using a 2 sided t-test.||3.80|-8.76|0.430
72593974|NCT03747302|144719475|SUPERIORITY|||||||0.003|||||||t-test, 2 sided|||||||.003
72593975|NCT03747302|144719476|SUPERIORITY||||||>|0.05|||||||t-test, 2 sided|||Change in mean scores for behavioral intent to vaccine: negative values: smaller values indicate more likely to vaccinate.||||>.05
72593976|NCT01032070|144719492|SUPERIORITY_OR_OTHER_LEGACY|||||||0.22||95.0||||P-value is not adjusted for multiple comparisons.|Fisher Exact|||The study was not powered for this comparison due to small sample size.||||0.2200
72593977|NCT00738062|144719506|SUPERIORITY_OR_OTHER|||||||0.438|||||||Mantel Haenszel|Mantel-Haenszel statistic comparing treatment groups based on rank statistics adjusted for the covariate OHSA Item 1 value at randomization.||||||0.438
72593978|NCT00738062|144719507|SUPERIORITY_OR_OTHER|||||||0.554|||||||Mantel Haenszel|Mantel-Haenszel statistic comparing treatment groups based on rank statistics adjusted for the covariate OHDAS Composite value at randomization.||||||0.554
72593979|NCT00738062|144719508|SUPERIORITY_OR_OTHER|||||||0.198|||||||Mantel Haenszel|Mantel-Haenszel statistic comparing treatment groups based on rank statistics adjusted for the covariate OHSA Composite value at baseline.||||||0.198
72593980|NCT00738062|144719509|SUPERIORITY_OR_OTHER|||||||0.286|||||||Mantel Haenszel|Mantel-Haenszel statistic comparing treatment groups based on rank statistics adjusted for the covariate OHSA Item 1 value at randomization.||||||0.286
72593981|NCT00738062|144719510|SUPERIORITY_OR_OTHER|||||||0.251|||||||Mantel Haenszel|Mantel-Haenszel statistic comparing treatment groups based on rank statistics adjusted for the covariate OHSA Item 1 value at randomization.||||||0.251
72593982|NCT00738062|144719511|SUPERIORITY_OR_OTHER|||||||0.708|||||||Fisher Exact|||||||0.708
72593983|NCT00738062|144719512|SUPERIORITY_OR_OTHER|||||||0.873|||||||Fisher Exact|||||||0.873
72414932|NCT01571362|144339961|SUPERIORITY_OR_OTHER||Difference of LS Means|-0.15|STANDARD_ERROR_OF_MEAN|0.262||0.5704|TWO_SIDED|95.0|-0.67|0.37|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariate.|Difference between treatment groups in change from Screening to Week 8.||0.37|-0.67|0.5704
72593984|NCT00738062|144719513|SUPERIORITY_OR_OTHER|||||||0.252|||||||Fisher Exact|||||||0.252
72593985|NCT00738062|144719514|SUPERIORITY_OR_OTHER|||||||0.33|||||||Fisher Exact|||||||0.330
72593986|NCT00426660|144719534|SUPERIORITY_OR_OTHER||75th percentile (median)|169.0|||||TWO_SIDED|95.0|135.0|178.0||||||||178.0|135.0|
72593987|NCT00426660|144719534|SUPERIORITY_OR_OTHER||50th percentile (median)|86.5|||||TWO_SIDED|95.0|82.0|92.0||||||||92.0|82.0|
72593988|NCT00426660|144719534|SUPERIORITY_OR_OTHER||25th percentile (median)|58.0|||||TWO_SIDED|95.0|57.0|62.0||||||||62.0|57.0|
72593989|NCT01432275|144719548|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Binomial test|Comparison to 27 participants that preferred their usual method to FreeStyle InsuLinx. Twelve(12) participants did not have a preference.||||||<0.0001
72593990|NCT01935700|144719550|NON_INFERIORITY|Non-inferiority was defined as no statistically significant difference (P value \> 0.05) in median survival between the colchicine group and the sorafenib treated group.||||||0.4593|||||||Mann-Whitney U test|||||||0.4593
72593991|NCT01935700|144719550|NON_INFERIORITY|Non-inferiority was defined as no statistically significant difference (P value \> 0.05) in survival between the colchicine group and the sorafenib treated group.||||||0.329|||||||Log Rank|||||||0.3290
72593992|NCT01935700|144719551|EQUIVALENCE|The threshold for statistically significant difference in incidence was P = 0.05.||||||0.0552||||||The threshold for statistically significant difference in incidence was P = 0.05.|Fisher Exact|||Comparison the incidence of grade III adverse event of pneumonia between two groups||||0.0552
72593993|NCT01935700|144719551|EQUIVALENCE|The threshold for statistically significant difference in incidence was P = 0.05.||||||0.0184||||||The threshold for statistically significant difference in incidence was P = 0.05.|Fisher Exact|||Comparison the incidence of grade III adverse event of biliary tract obstruction between two groups||||0.0184
72593994|NCT01935700|144719551|EQUIVALENCE|The threshold for statistically significant difference in incidence was P = 0.05.||||||0.0931||||||The threshold for statistically significant difference in incidence was P = 0.05.|Fisher Exact|||Comparison the incidence of grade III adverse event of cholangitis between two groups||||0.0931
72593995|NCT01935700|144719551|EQUIVALENCE|The threshold for statistically significant difference in incidence was P = 0.05.||||||0.0506||||||The threshold for statistically significant difference in incidence was P = 0.05.|Fisher Exact|||Comparison the incidence of grade III adverse event of peritonitis between two groups||||0.0506
72414933|NCT01571362|144339961|SUPERIORITY_OR_OTHER||Difference of LS Means|-0.64|STANDARD_ERROR_OF_MEAN|0.245||0.0096|TWO_SIDED|95.0|-1.12|-0.16|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariate.|Difference between treatment groups in change from Screening to Week 12/ Early Termination.||-0.16|-1.12|0.0096
72414934|NCT01571362|144339962|SUPERIORITY_OR_OTHER||Difference of LS Means|-27.75|STANDARD_ERROR_OF_MEAN|10.968||0.012|TWO_SIDED|95.0|-49.34|-6.16|||ANCOVA||Difference between treatment groups evaluated by ANCOVA with treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|||-6.16|-49.34|0.0120
72414935|NCT01571362|144339963|SUPERIORITY_OR_OTHER||Difference of LS Means|-3.87|STANDARD_ERROR_OF_MEAN|50.5||0.939|TWO_SIDED|95.0|-103.29|95.55|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the average daily rescue acetaminophen during the Titration Period and final total daily study medication dose of the Titration Period as covariates.|||95.55|-103.29|0.9390
72414936|NCT01571362|144339969|SUPERIORITY_OR_OTHER|||||||0.0014|||||||Wilcoxon test, survival analysis|P-value from Wilcoxon test with treatment and opioid stratum as factors||Time to 20% loss of analgesic response||||0.0014
72414937|NCT01571362|144339969|SUPERIORITY_OR_OTHER|||||||0.0024|||||||Wilcoxon test, survival analysis|P-value from Wilcoxon test with treatment and opioid stratum as factors||Time to 30% loss of analgesic response.||||0.0024
72414938|NCT01571362|144339969|SUPERIORITY_OR_OTHER|||||||0.0006|||||||Wilcoxon test, survival analysis|P-value from Wilcoxon test with treatment and opioid stratum as factors||Time to 40% loss of analgesic response.||||0.0006
72414939|NCT01571362|144339969|SUPERIORITY_OR_OTHER|||||||0.0021|||||||Wilcoxon test, survival analysis|P-value from Wilcoxon test with treatment and opioid stratum as factors||Time to 50% loss of analgesic response||||0.0021
72414940|NCT01571362|144339971|SUPERIORITY_OR_OTHER|||||||0.006|||||||Wilcoxon test, survival analysis|P-value from Wilcoxon test with treatment and opioid stratum as factors.||||||0.006
72414941|NCT01571362|144339981|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||Change from Screening Period value to the End of Open-Label Titration Period.||||<0.0001
72414942|NCT01571362|144339982|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||Change from Screening Period value to Randomization Baseline.||||<0.0001
72593996|NCT01935700|144719551|EQUIVALENCE|The threshold for statistically significant difference in incidence was P = 0.05.||||||1||||||The threshold for statistically significant difference in incidence was P = 0.05.|Fisher Exact|||Comparison the incidence of grade III adverse event of sepsis between two groups||||1
72593997|NCT01935700|144719551|EQUIVALENCE|The threshold for statistically significant difference in incidence was P = 0.05.||||||0.5374||||||The threshold for statistically significant difference in incidence was P = 0.05.|Fisher Exact|||Comparison the incidence of grade III adverse event of diarrhea between two groups||||0.5374
72593998|NCT01935700|144719551|EQUIVALENCE|The threshold for statistically significant difference in incidence was P = 0.05.||||||0.14||||||The threshold for statistically significant difference in incidence was P = 0.05.|Fisher Exact|||Comparison the incidence of grade III adverse event of anorexia between two groups||||0.14
72593999|NCT01935700|144719551|EQUIVALENCE|The threshold for statistically significant difference in incidence was P = 0.05.||||||0.4584||||||The threshold for statistically significant difference in incidence was P = 0.05.|Fisher Exact|||Comparison the incidence of grade III adverse event of abdominal pain between two groups||||0.4584
72594000|NCT01935700|144719551|EQUIVALENCE|The threshold for statistically significant difference in incidence was P = 0.05.||||||1||||||The threshold for statistically significant difference in incidence was P = 0.05.|Fisher Exact|||Comparison the incidence of grade III adverse event of skin rash between two groups||||1
72594001|NCT01935700|144719551|EQUIVALENCE|The threshold for statistically significant difference in incidence was P = 0.05.||||||1||||||The threshold for statistically significant difference in incidence was P = 0.05.|Fisher Exact|||Comparison the incidence of grade III adverse event of palmar-plantar erythrodysesthesia syndrome between two groups||||1
72594002|NCT01935700|144719551|EQUIVALENCE|The threshold for statistically significant difference in incidence was P = 0.05.||||||1||||||The threshold for statistically significant difference in incidence was P = 0.05.|Fisher Exact|||Comparison the incidence of grade III adverse event of hypertension between two groups||||1
72594003|NCT01935700|144719551|EQUIVALENCE|The threshold for statistically significant difference in incidence was P = 0.05.||||||0.5958||||||The threshold for statistically significant difference in incidence was P = 0.05.|Fisher Exact|||Comparison the incidence of grade III adverse event of hemorrhage between two groups||||0.5958
72594004|NCT01935700|144719551|EQUIVALENCE|The threshold for statistically significant difference in incidence was P = 0.05.||||||0.14||||||The threshold for statistically significant difference in incidence was P = 0.05.|Fisher Exact|||Comparison the incidence of grade III adverse event of hypoglycemia between two groups||||0.14
72594005|NCT01935700|144719551|EQUIVALENCE|The threshold for statistically significant difference in incidence was P = 0.05.||||||1||||||The threshold for statistically significant difference in incidence was P = 0.05.|Fisher Exact|||Comparison the incidence of grade III adverse event of hyperglycemia between two groups||||1
72594006|NCT01935700|144719551|EQUIVALENCE|The threshold for statistically significant difference in incidence was P = 0.05.||||||1||||||The threshold for statistically significant difference in incidence was P = 0.05.|Fisher Exact|||Comparison the incidence of grade III adverse event of hypocalcemia between two groups||||1
72594007|NCT01935700|144719551|EQUIVALENCE|The threshold for statistically significant difference in incidence was P = 0.05.||||||1||||||The threshold for statistically significant difference in incidence was P = 0.05.|Fisher Exact|||Comparison the incidence of grade III adverse event of pleural effusion between two groups||||1
72594008|NCT02124759|144719570|SUPERIORITY||||||>|0.05|||||||t-test, 2 sided|Paired T-test||Null hypothesis is that high fat diet will have no effect on M value, the measure of insulin sensitivity for each intervention as assessed by clamp.||||>0.05
72594009|NCT01785849|144719580|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|32.46|||<|0.001|TWO_SIDED|95.0|18.71|56.31|||Cochran-Mantel-Haenszel|||A Cochran-Mantel-Haenszel test stratified by screening PTH category (\< 600, ≥ 600 to ≤ 1000, and \> 1000 pg/mL), recent cinacalcet use within 8 weeks before randomization (yes and no), and region (North America and non-North America) was used to compare the primary endpoint of proportion of participants with \> 30% reduction from baseline in PTH during the EAP between etelcalcetide and placebo.||56.31|18.71|<0.001
72594010|NCT01785849|144719581|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|22.08|||<|0.001|TWO_SIDED|95.0|11.47|42.48|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by screening PTH category, recent cinacalcet use within 8 weeks before randomization, and region.||||42.48|11.47|<0.001
72594011|NCT01785849|144719582|SUPERIORITY_OR_OTHER||Mean Difference|-71.11|STANDARD_ERROR_OF_MEAN|3.39|<|0.001|TWO_SIDED|95.0|-77.77|-64.46|||Repeated Measures Mixed Effects Model|Repeated measures mixed-effects model included treatment, stratification factors, visit, and treatment by visit interaction as covariates.|Etelcalcetide - Placebo|||-64.46|-77.77|<0.001
72594012|NCT01785849|144719583|SUPERIORITY_OR_OTHER||Mean Difference|-8.38|STANDARD_ERROR_OF_MEAN|0.58|<|0.001|TWO_SIDED|95.0|-9.52|-7.23|||Repeated Measures Mixed Effects Model|Repeated measures mixed-effects model included treatment, stratification factors, visit, and treatment by visit interaction as covariates.|Etelcalcetide - Placebo|||-7.23|-9.52|<0.001
72594013|NCT01785849|144719584|SUPERIORITY_OR_OTHER||Mean Difference|-14.99|STANDARD_ERROR_OF_MEAN|2.41|<|0.001|TWO_SIDED|95.0|-19.73|-10.25|||Repeated Measures Mixed Effects Model|Repeated measures mixed-effects model included treatment, stratification factors, visit, and treatment by visit interaction as covariates.|Etelcalcetide - Placebo|||-10.25|-19.73|<0.001
72594014|NCT01785849|144719585|SUPERIORITY_OR_OTHER||Mean Difference|-7.45|STANDARD_ERROR_OF_MEAN|2.47||0.003|TWO_SIDED|95.0|-12.31|-2.59|||Repeated Measures Mixed Effects Model|Repeated measures mixed-effects model included treatment, stratification factors, visit, and treatment by visit interaction as covariates.|Etelcalcetide - Placebo|||-2.59|-12.31|0.003
72594015|NCT04250298|144719605|OTHER|||||||0.031|||||||t-test, 2 sided|||||||0.031
72594016|NCT04250298|144719606|OTHER|||||||0.267|||||||t-test, 2 sided|||||||0.267
72414943|NCT01571362|144339983|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.05|STANDARD_ERROR_OF_MEAN|0.584||0.0733|TWO_SIDED|95.0|-2.2|0.1||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariate.|ANCOVA|||Model-adjusted Change from Screening to Week 2.||0.10|-2.20|0.0733
72414944|NCT01571362|144339983|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.7|STANDARD_ERROR_OF_MEAN|0.642||0.2783|TWO_SIDED|95.0|-1.96|0.57||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariate.|ANCOVA|||Model-adjusted Change from Screening to Week 4.||0.57|-1.96|0.2783
72594017|NCT04250298|144719607|OTHER|||||||0.228|||||||t-test, 2 sided|||||||0.228
72594018|NCT04250298|144719608|OTHER|||||||0.267|||||||t-test, 2 sided|||||||0.267
72594019|NCT04250298|144719609|OTHER||||||>|0.999|||||||Fisher Exact|||||||>0.999
72594020|NCT04250298|144719610|OTHER|||||||0.318|||||||Fisher Exact|||||||0.318
72594021|NCT04250298|144719611|OTHER|||||||0.348|||||||Fisher Exact|||||||0.348
72594022|NCT04250298|144719612|OTHER|||||||0.548|||||||Wilcoxon (Mann-Whitney)|||||||0.548
72594023|NCT04250298|144719613|OTHER|||||||0.401|||||||Wilcoxon (Mann-Whitney)|||||||0.401
72594024|NCT04250298|144719614|OTHER|||||||0.506|||||||Wilcoxon (Mann-Whitney)|||||||0.506
72594025|NCT04250298|144719615|OTHER|||||||0.506|||||||Wilcoxon (Mann-Whitney)|||||||0.506
72594026|NCT04250298|144719621|OTHER|Mann-Whitney U test, Fisher Exact, Chi-Squared, Kolmogorv-Smirnow||||||0.919|||||||Wilcoxon (Mann-Whitney)|||"sub-population 1 vs. sub-population 2: Parametric and nonparametric univariate tests: t-test for independent samples, Mann-Whitney-U test, Fisher's exact test, chi-square homogeneity test; normal distribution check by Kolmogorov-Smirnov test with Lilliefors -significance correction, type I error = 10%).~Estimate the true effect size:~Two-sided 95% confidence intervals (depending on the nature of the data sets: parametric, non-parametric or Clopper-Pearson) are calculated for all parameters."||||0.919
72594027|NCT04250298|144719623|OTHER|||||||0.033|||||||t-test, 2 sided|||||||0.033
72594028|NCT04250298|144719624|OTHER|||||||0.585|||||||t-test, 2 sided|||||||0.585
72594029|NCT04250298|144719625|OTHER|||||||0.676|||||||t-test, 2 sided|||||||0.676
72594030|NCT04250298|144719626|OTHER|||||||0.314|||||||Wilcoxon (Mann-Whitney)|||||||0.314
72594031|NCT04250298|144719631|OTHER|||||||0.031|||||||t-test, 2 sided|||||||0.031
72594032|NCT04250298|144719632|OTHER|||||||0.862|||||||t-test, 2 sided|||||||0.862
72594033|NCT04250298|144719633|OTHER|||||||0.25|||||||Fisher Exact|||||||0.250
72594034|NCT04250298|144719634|OTHER|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||||||0.001
72594035|NCT04250298|144719635|OTHER|||||||0.001|||||||Fisher Exact|||||||0.001
72594036|NCT04250298|144719636|OTHER|||||||0.055|||||||Wilcoxon (Mann-Whitney)|||||||0.055
72594037|NCT04250298|144719637|OTHER|||||||0.111|||||||Wilcoxon (Mann-Whitney)|||||||0.111
72594038|NCT04250298|144719638|OTHER|||||||0.1|||||||Wilcoxon (Mann-Whitney)|||||||0.100
72594039|NCT04250298|144719641|OTHER|||||||0.111|||||||Wilcoxon (Mann-Whitney)|||||||0.111
72594040|NCT04250298|144719642|OTHER|||||||0.213|||||||Wilcoxon (Mann-Whitney)|||||||0.213
72594041|NCT02431806|144719662|SUPERIORITY||Least Squares (LS) Mean Difference|-0.38||||0.8035|TWO_SIDED|95.0|-3.41|2.64|||Mixed Model Repeated Measures (MMRM)||Estimates and p-values are based on MMRM with treatment group, pooled study center, visit, and treatment group-by-visit interaction as fixed effects, and baseline and baseline-by-visit as covariates using an unstructured covariance matrix.|||2.64|-3.41|0.8035
72594042|NCT02431806|144719662|SUPERIORITY||LS Mean Difference|0.26||||0.8681|TWO_SIDED|95.0|-2.8|3.31|||MMRM||Estimates and p-values are based on MMRM with treatment group, pooled study center, visit, and treatment group-by-visit interaction as fixed effects, and baseline and baseline-by-visit as covariates using an unstructured covariance matrix.|||3.31|-2.80|0.8681
72594043|NCT02431806|144719662|SUPERIORITY||LS Mean|-1.47||||0.3439|TWO_SIDED|95.0|-4.52|1.58|||MMRM||Estimates and p-values are based on MMRM with treatment group, pooled study center, visit, and treatment group-by-visit interaction as fixed effects, and baseline and baseline-by-visit as covariates using an unstructured covariance matrix.|||1.58|-4.52|0.3439
72594044|NCT02431806|144719663|SUPERIORITY||LS Mean Difference|0.02||||0.8788|TWO_SIDED|95.0|-0.25|0.29|||MMRM||Estimates and p-values are based on MMRM with treatment group, pooled study center, visit, and treatment group-by-visit interaction as fixed effects, and baseline and baseline-by-visit as covariates using an unstructured covariance matrix.|||0.29|-0.25|0.8788
72594045|NCT02431806|144719663|SUPERIORITY||LS Mean Difference|0.01||||0.923|TWO_SIDED|95.0|-0.26|0.29|||MMRM||Estimates and p-values are based on MMRM with treatment group, pooled study center, visit, and treatment group-by-visit interaction as fixed effects, and baseline and baseline-by-visit as covariates using an unstructured covariance matrix.|||0.29|-0.26|0.9230
72594046|NCT02431806|144719663|SUPERIORITY||LS Mean Difference|-0.15||||0.2895|TWO_SIDED|95.0|-0.42|0.13|||MMRM||Estimates and p-values are based on MMRM with treatment group, pooled study center, visit, and treatment group-by-visit interaction as fixed effects, and baseline and baseline-by-visit as covariates using an unstructured covariance matrix.|||0.13|-0.42|0.2895
72594047|NCT02923245|144719686|OTHER||Mean Difference (Final Values)|49.7|||||TWO_SIDED|95.0|23.4|77.2|||||These confidence intervals correspond to the bootstrap analysis|||77.2|23.4|
72594048|NCT02923245|144719687|OTHER||Difference in percentages|15.3||||0.006|TWO_SIDED|95.0|5.3|25.0|||Test of proportions|||||25.0|5.3|0.006
72594049|NCT00793624|144719718|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.151|STANDARD_ERROR_OF_MEAN|0.021|<|0.0001||95.0|0.11|0.193|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.193|0.110|<0.0001
72594050|NCT00793624|144719718|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.165|STANDARD_ERROR_OF_MEAN|0.021|<|0.0001||95.0|0.124|0.206|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.206|0.124|<0.0001
72414945|NCT01571362|144339983|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.58|STANDARD_ERROR_OF_MEAN|0.684||0.3951|TWO_SIDED|95.0|-0.77|1.93||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariate.|ANCOVA|||Model-adjusted Change from Screening to Week 8.||1.93|-0.77|0.3951
72594051|NCT00793624|144719718|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.177|STANDARD_ERROR_OF_MEAN|0.021|<|0.0001||95.0|0.136|0.218|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.218|0.136|<0.0001
72594052|NCT00793624|144719719|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.078|STANDARD_ERROR_OF_MEAN|0.021||0.0002||95.0|0.037|0.118|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.118|0.037|0.0002
72594053|NCT00793624|144719719|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.085|STANDARD_ERROR_OF_MEAN|0.021|<|0.0001||95.0|0.044|0.125|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.125|0.044|<0.0001
72594054|NCT00793624|144719719|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.054|STANDARD_ERROR_OF_MEAN|0.021||0.0088||95.0|0.014|0.095|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.095|0.014|0.0088
72594055|NCT00793624|144719720|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.188|STANDARD_ERROR_OF_MEAN|0.343||0.5843||95.0|-0.485|0.86|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.860|-0.485|0.5843
72594056|NCT00793624|144719720|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.022|STANDARD_ERROR_OF_MEAN|0.345||0.9494||95.0|-0.656|0.699|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.699|-0.656|0.9494
72594057|NCT00793624|144719720|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.288|STANDARD_ERROR_OF_MEAN|0.346||0.5099||95.0|-0.908|0.451|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.451|-0.908|0.5099
72594058|NCT00793624|144719721|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.442|STANDARD_ERROR_OF_MEAN|1.401||0.0816||95.0|-5.19|0.307|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.307|-5.190|0.0816
72594059|NCT00793624|144719721|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.394|STANDARD_ERROR_OF_MEAN|1.4||0.0155||95.0|-6.141|-0.648|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||-0.648|-6.141|0.0155
72594060|NCT00793624|144719721|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.952|STANDARD_ERROR_OF_MEAN|1.396||0.4954||95.0|-3.691|1.787|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||1.787|-3.691|0.4954
72594061|NCT00793624|144719722|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.785|STANDARD_ERROR_OF_MEAN|1.387||0.045||95.0|-5.507|-0.063|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||-0.063|-5.507|0.0450
72594062|NCT00793624|144719722|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.144|STANDARD_ERROR_OF_MEAN|1.386||0.0002||95.0|-7.864|-2.425|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||-2.425|-7.864|0.0002
72594063|NCT00793624|144719722|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.754|STANDARD_ERROR_OF_MEAN|1.386||0.2061||95.0|-4.474|0.966|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.966|-4.474|0.2061
72594064|NCT00793624|144719723|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.871|STANDARD_ERROR_OF_MEAN|1.419||0.1878||95.0|-4.655|0.914|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.914|-4.655|0.1878
72594065|NCT00793624|144719723|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.565|STANDARD_ERROR_OF_MEAN|1.427||0.0126||95.0|-6.364|-0.767|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||-0.767|-6.364|0.0126
72594066|NCT00793624|144719723|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.016|STANDARD_ERROR_OF_MEAN|1.426||0.9913||95.0|-2.782|2.814|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||2.814|-2.782|0.9913
72594067|NCT00793624|144719724|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.846|STANDARD_ERROR_OF_MEAN|0.972||0.0034||95.0|-4.751|-0.94|||Mixed Models Analysis||Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo||-0.940|-4.751|0.0034
72594068|NCT00793624|144719724|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.434|STANDARD_ERROR_OF_MEAN|0.973||0.0004||95.0|-5.343|-1.525|||Mixed Models Analysis||Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo||-1.525|-5.343|0.0004
72594069|NCT00793624|144719724|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.248|STANDARD_ERROR_OF_MEAN|0.976||0.2009||95.0|-3.161|0.665|||Mixed Models Analysis||Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 10 mcg qd minus Placebo||0.665|-3.161|0.2009
72414946|NCT01571362|144339983|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.07|STANDARD_ERROR_OF_MEAN|0.614||0.9063|TWO_SIDED|95.0|-1.14|1.28||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariate.|ANCOVA|||Model-adjusted Change from Screening to Week 12.||1.28|-1.14|0.9063
72414947|NCT01571362|144339984|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.74|STANDARD_ERROR_OF_MEAN|0.463||0.1139|TWO_SIDED|95.0|-1.65|0.18||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|ANCOVA|||Model-adjusted change from Baseline to Week 2.||0.18|-1.65|0.1139
72414948|NCT01571362|144339984|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.7|STANDARD_ERROR_OF_MEAN|0.577||0.2264|TWO_SIDED|95.0|-1.84|0.44||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|ANCOVA|||Model-adjusted Change from Baseline to Week 4.||0.44|-1.84|0.2264
72414949|NCT01571362|144339984|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.41|STANDARD_ERROR_OF_MEAN|0.619||0.5074|TWO_SIDED|95.0|-0.81|1.63||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|ANCOVA|||Model-adjusted Change from Baseline to Week 8.||1.63|-0.81|0.5074
72414950|NCT01571362|144339985|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Bowker's test of symmetry|||||||<0.0001
72414951|NCT01571362|144339986|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Bowker's test of symmetry|||||||<0.0001
72414952|NCT01571362|144339987|SUPERIORITY_OR_OTHER|||||||0.2211|||||||Cochran-Mantel-Haenszel|Stratified by opioid stratum.||||||0.2211
72414953|NCT01571362|144339988|SUPERIORITY_OR_OTHER|||||||0.5767|||||||Cochran-Mantel-Haenszel|Stratified by opioid stratum.||||||0.5767
72414954|NCT01571362|144339991|SUPERIORITY_OR_OTHER|||||||0.0004|||||||Cochran-Mantel-Haenszel|Stratified by opioid stratum.||||||0.0004
72414955|NCT01571362|144339992|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||Change from Screening Period value to End of Open-Label Titration Period for Physical Functioning.||||<0.0001
72414956|NCT01571362|144339992|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||Change from Screening Period value to End of Open-Label Titration Period for Role-Physical.||||<0.0001
72594070|NCT00793624|144719725|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.186|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001||95.0|0.146|0.226|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.226|0.146|<0.0001
72594071|NCT00793624|144719725|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.166|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001||95.0|0.126|0.206|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.206|0.126|<0.0001
72594072|NCT00793624|144719725|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.206|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001||95.0|0.166|0.246|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.246|0.166|<0.0001
72594073|NCT00793624|144719726|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.176|STANDARD_ERROR_OF_MEAN|0.021|<|0.0001||95.0|0.136|0.217|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.217|0.136|<0.0001
72594074|NCT00793624|144719726|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.16|STANDARD_ERROR_OF_MEAN|0.021|<|0.0001||95.0|0.119|0.2|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.200|0.119|<0.0001
72594075|NCT00793624|144719726|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.192|STANDARD_ERROR_OF_MEAN|0.021|<|0.0001||95.0|0.152|0.233|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.233|0.152|<0.0001
72594076|NCT00793624|144719727|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.178|STANDARD_ERROR_OF_MEAN|0.021|<|0.0001||95.0|0.137|0.219|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.219|0.137|<0.0001
72594077|NCT00793624|144719727|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.17|STANDARD_ERROR_OF_MEAN|0.021|<|0.0001||95.0|0.129|0.211|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.211|0.129|<0.0001
72594078|NCT00793624|144719727|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.185|STANDARD_ERROR_OF_MEAN|0.021|<|0.0001||95.0|0.144|0.226|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.226|0.144|<0.0001
72594079|NCT00793624|144719728|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.145|STANDARD_ERROR_OF_MEAN|0.021|<|0.0001||95.0|0.103|0.186|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.186|0.103|<0.0001
72594080|NCT00793624|144719728|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.146|STANDARD_ERROR_OF_MEAN|0.021|<|0.0001||95.0|0.105|0.188|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.188|0.105|<0.0001
72594081|NCT00793624|144719728|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.172|STANDARD_ERROR_OF_MEAN|0.021|<|0.0001||95.0|0.13|0.214|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.214|0.130|<0.0001
72594082|NCT00793624|144719729|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.087|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001||95.0|0.048|0.126|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.126|0.048|<0.0001
72414957|NCT01571362|144339992|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||Change from Screening Period value to End of Open-Label Titration Period for Bodily Pain.||||<0.0001
72414958|NCT01571362|144339992|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||Change from Screening Period value to End of Open-Label Titration Period for General Health.||||<0.0001
72414959|NCT01571362|144339992|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||Change from Screening Period value to End of Open-Label Titration Period for Vitality.||||<0.0001
72414960|NCT01571362|144339992|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||Change from Screening Period value to End of Open-Label Titration Period for Social Functioning.||||<0.0001
72414961|NCT01571362|144339992|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||Change from Screening Period value to End of Open-Label Titration Period for Role-Emotional.||||<0.0001
72414962|NCT01571362|144339992|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||Change from Screening Period value to End of Open-Label Titration Period for Mental Health.||||<0.0001
72414963|NCT01571362|144339992|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||Change from Screening Period value to End of Open-Label Titration Period for Physical Component Score.||||<0.0001
72414964|NCT01571362|144339992|SUPERIORITY_OR_OTHER|||||||0.0026|||||||t-test, 2 sided|||Change from Screening Period value to End of Open-Label Titration Period for Mental Component Score.||||0.0026
72414965|NCT01571362|144339993|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||Change from Screening Period value to Randomization Baseline for Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional, Mental Health, Physical Component Score, and Mental Component Score||||<0.0001
72594083|NCT00793624|144719729|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.079|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001||95.0|0.04|0.118|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.118|0.040|<0.0001
72594084|NCT00793624|144719729|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.08|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001||95.0|0.04|0.119|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.119|0.040|<0.0001
72594085|NCT00793624|144719730|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.086|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001||95.0|0.047|0.125|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.125|0.047|<0.0001
72594086|NCT00793624|144719730|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.078|STANDARD_ERROR_OF_MEAN|0.02||0.0001||95.0|0.038|0.117|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.117|0.038|0.0001
72594087|NCT00793624|144719730|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.079|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001||95.0|0.039|0.119|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.119|0.039|<0.0001
72594088|NCT00793624|144719731|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.083|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001||95.0|0.043|0.123|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.123|0.043|<0.0001
72594089|NCT00793624|144719731|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.075|STANDARD_ERROR_OF_MEAN|0.02||0.0002||95.0|0.035|0.114|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.114|0.035|0.0002
72594090|NCT00793624|144719731|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.059|STANDARD_ERROR_OF_MEAN|0.02||0.0037||95.0|0.019|0.1|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.100|0.019|0.0037
72594091|NCT00793624|144719732|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.065|STANDARD_ERROR_OF_MEAN|0.02||0.0016||95.0|0.025|0.105|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.105|0.025|0.0016
72594092|NCT00793624|144719732|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.045|STANDARD_ERROR_OF_MEAN|0.02||0.0276||95.0|0.005|0.085|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.085|0.005|0.0276
72594093|NCT00793624|144719732|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.042|STANDARD_ERROR_OF_MEAN|0.021||0.0426||95.0|0.001|0.082|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.082|0.001|0.0426
72594094|NCT00793624|144719733|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.047|STANDARD_ERROR_OF_MEAN|0.021||0.0237||95.0|0.006|0.087|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.087|0.006|0.0237
72594095|NCT00793624|144719733|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.049|STANDARD_ERROR_OF_MEAN|0.021||0.0175||95.0|0.009|0.09|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.090|0.009|0.0175
72594096|NCT00793624|144719733|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.044|STANDARD_ERROR_OF_MEAN|0.021||0.0339||95.0|0.003|0.085|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.085|0.003|0.0339
72594097|NCT00793624|144719734|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.04|STANDARD_ERROR_OF_MEAN|0.021||0.0537||95.0|-0.001|0.081|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.081|-0.001|0.0537
72594098|NCT00793624|144719734|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.037|STANDARD_ERROR_OF_MEAN|0.021||0.0808||95.0|-0.004|0.078|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.078|-0.004|0.0808
72594099|NCT00793624|144719734|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.024|STANDARD_ERROR_OF_MEAN|0.021||0.2579||95.0|-0.017|0.065|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.065|-0.017|0.2579
72594100|NCT00793624|144719735|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.068|STANDARD_ERROR_OF_MEAN|0.021||0.0011||95.0|0.027|0.109|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.109|0.027|0.0011
72414966|NCT01571362|144339994|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.62|STANDARD_ERROR_OF_MEAN|0.952||0.5181|TWO_SIDED|95.0|-1.26|2.49||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|ANCOVA|||Difference between treatment groups in change from Randomization Baseline for Physical Functioning.||2.49|-1.26|0.5181
72594101|NCT00793624|144719735|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.059|STANDARD_ERROR_OF_MEAN|0.021||0.0069||95.0|0.018|0.101|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.101|0.018|0.0069
72594102|NCT00793624|144719735|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.08|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001||95.0|0.04|0.119|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.119|0.040|<0.0001
72594103|NCT00793624|144719736|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.177|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001||95.0|0.135|0.22|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.220|0.135|<0.0001
72594104|NCT00793624|144719736|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.15|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001||95.0|0.108|0.193|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.193|0.108|<0.0001
72594105|NCT00793624|144719736|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.19|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001||95.0|0.148|0.233|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.233|0.148|<0.0001
72594106|NCT00793624|144719737|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.166|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001||95.0|0.124|0.209|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.209|0.124|<0.0001
72594107|NCT00793624|144719737|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.152|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001||95.0|0.109|0.195|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.195|0.109|<0.0001
72594108|NCT00793624|144719737|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.182|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001||95.0|0.139|0.226|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.226|0.139|<0.0001
72594109|NCT00793624|144719738|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.165|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001||95.0|0.122|0.208|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.208|0.122|<0.0001
72594110|NCT00793624|144719738|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.159|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001||95.0|0.116|0.203|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.203|0.116|<0.0001
72594111|NCT00793624|144719738|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.174|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001||95.0|0.13|0.218|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.218|0.130|<0.0001
72594112|NCT00793624|144719739|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.148|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001||95.0|0.104|0.191|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.191|0.104|<0.0001
72594113|NCT00793624|144719739|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.167|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001||95.0|0.112|0.2|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.200|0.112|<0.0001
72594114|NCT00793624|144719739|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.167|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001||95.0|0.123|0.211|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.211|0.123|<0.0001
72594115|NCT00793624|144719740|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.139|STANDARD_ERROR_OF_MEAN|0.023|<|0.0001||95.0|0.095|0.183|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.183|0.095|<0.0001
72594116|NCT00793624|144719740|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.14|STANDARD_ERROR_OF_MEAN|0.023|<|0.0001||95.0|0.095|0.184|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.184|0.095|<0.0001
72594117|NCT00793624|144719740|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.162|STANDARD_ERROR_OF_MEAN|0.023|<|0.0001||95.0|0.117|0.206|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.206|0.117|<0.0001
72594118|NCT00793624|144719741|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.223|STANDARD_ERROR_OF_MEAN|0.038|<|0.0001||95.0|0.149|0.297|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.297|0.149|<0.0001
72594119|NCT00793624|144719741|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.235|STANDARD_ERROR_OF_MEAN|0.038|<|0.0001||95.0|0.161|0.309|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.309|0.161|<0.0001
72594120|NCT00793624|144719741|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.307|STANDARD_ERROR_OF_MEAN|0.038|<|0.0001||95.0|0.233|0.381|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.381|0.233|<0.0001
72594121|NCT00793624|144719742|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.236|STANDARD_ERROR_OF_MEAN|0.038|<|0.0001||95.0|0.161|0.31|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.310|0.161|<0.0001
72594122|NCT00793624|144719742|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.249|STANDARD_ERROR_OF_MEAN|0.038|<|0.0001||95.0|0.175|0.324|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.324|0.175|<0.0001
72594123|NCT00793624|144719742|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.31|STANDARD_ERROR_OF_MEAN|0.038|<|0.0001||95.0|0.235|0.384|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.384|0.235|<0.0001
72594124|NCT00793624|144719743|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.21|STANDARD_ERROR_OF_MEAN|0.038|<|0.0001||95.0|0.135|0.285|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.285|0.135|<0.0001
72594125|NCT00793624|144719743|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.254|STANDARD_ERROR_OF_MEAN|0.038|<|0.0001||95.0|0.179|0.329|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.329|0.179|<0.0001
72594126|NCT00793624|144719743|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.276|STANDARD_ERROR_OF_MEAN|0.039|<|0.0001||95.0|0.201|0.352|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.352|0.201|<0.0001
72594127|NCT00793624|144719744|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.182|STANDARD_ERROR_OF_MEAN|0.039|<|0.0001||95.0|0.107|0.258|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.258|0.107|<0.0001
72594128|NCT00793624|144719744|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.215|STANDARD_ERROR_OF_MEAN|0.039|<|0.0001||95.0|0.139|0.291|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.291|0.139|<0.0001
72594129|NCT00793624|144719744|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.242|STANDARD_ERROR_OF_MEAN|0.039|<|0.0001||95.0|0.166|0.318|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.318|0.166|<0.0001
72414967|NCT01571362|144339994|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.03|STANDARD_ERROR_OF_MEAN|0.998||0.9733|TWO_SIDED|95.0|-2.0|1.93||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|ANCOVA|||Difference between treatment groups in change from Randomization Baseline for Role-Physical.||1.93|-2.00|0.9733
72414968|NCT01571362|144339994|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.37|STANDARD_ERROR_OF_MEAN|0.914||0.01|TWO_SIDED|95.0|0.57|4.18||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|ANCOVA|||Difference between treatment groups in change from Randomization Baseline for Bodily Pain.||4.18|0.57|0.0100
72594130|NCT00793624|144719745|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.179|STANDARD_ERROR_OF_MEAN|0.039|<|0.0001||95.0|0.103|0.256|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.256|0.103|<0.0001
72414969|NCT01571362|144339994|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.55|STANDARD_ERROR_OF_MEAN|0.764||0.4712|TWO_SIDED|95.0|-2.06|0.95||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|ANCOVA|||Difference between treatment groups in change from Randomization Baseline for General Health Perceptions.||0.95|-2.06|0.4712
72594131|NCT00793624|144719745|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.203|STANDARD_ERROR_OF_MEAN|0.039|<|0.0001||95.0|0.126|0.28|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.280|0.126|<0.0001
72594132|NCT00793624|144719745|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.243|STANDARD_ERROR_OF_MEAN|0.039|<|0.0001||95.0|0.166|0.32|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.320|0.166|<0.0001
72594133|NCT00793624|144719746|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.068|STANDARD_ERROR_OF_MEAN|0.039||0.0781||95.0|-0.008|0.143|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.143|-0.008|0.0781
72594134|NCT00793624|144719746|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.077|STANDARD_ERROR_OF_MEAN|0.039||0.0455||95.0|0.002|0.153|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.153|0.002|0.0455
72594135|NCT00793624|144719746|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.085|STANDARD_ERROR_OF_MEAN|0.039||0.029||95.0|0.009|0.16|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.160|0.009|0.0290
72594136|NCT00793624|144719747|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.11|STANDARD_ERROR_OF_MEAN|0.039||0.0043||95.0|0.035|0.186|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.186|0.035|0.0043
72594137|NCT00793624|144719747|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.131|STANDARD_ERROR_OF_MEAN|0.039||0.0007||95.0|0.055|0.207|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.207|0.055|0.0007
72594138|NCT00793624|144719747|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.136|STANDARD_ERROR_OF_MEAN|0.039||0.0005||95.0|0.06|0.212|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.212|0.060|0.0005
72594139|NCT00793624|144719748|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.097|STANDARD_ERROR_OF_MEAN|0.039||0.0136||95.0|0.02|0.173|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.173|0.020|0.0136
72594140|NCT00793624|144719748|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.105|STANDARD_ERROR_OF_MEAN|0.039||0.0076||95.0|0.028|0.182|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.182|0.028|0.0076
72594141|NCT00793624|144719748|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.086|STANDARD_ERROR_OF_MEAN|0.039||0.0294||95.0|0.009|0.163|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.163|0.009|0.0294
72594142|NCT00793624|144719749|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.007|STANDARD_ERROR_OF_MEAN|0.039||0.8674||95.0|-0.071|0.084|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.084|-0.071|0.8674
72594143|NCT00793624|144719749|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.018|STANDARD_ERROR_OF_MEAN|0.04||0.6487||95.0|-0.06|0.096|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.096|-0.060|0.6487
72594144|NCT00793624|144719749|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.004|STANDARD_ERROR_OF_MEAN|0.04||0.9267||95.0|-0.074|0.081|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.081|-0.074|0.9267
72594145|NCT00793624|144719750|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.056|STANDARD_ERROR_OF_MEAN|0.04||0.1603||95.0|-0.022|0.134|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.134|-0.022|0.1603
72594146|NCT00793624|144719750|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.082|STANDARD_ERROR_OF_MEAN|0.04||0.0399||95.0|0.004|0.16|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.160|0.004|0.0399
72594147|NCT00793624|144719750|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.019|STANDARD_ERROR_OF_MEAN|0.04||0.6328||95.0|-0.059|0.098|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.098|-0.059|0.6328
72594148|NCT00793624|144719751|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.061|STANDARD_ERROR_OF_MEAN|0.04||0.127||95.0|-0.017|0.139|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.139|-0.017|0.1270
72594149|NCT00793624|144719751|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.064|STANDARD_ERROR_OF_MEAN|0.04||0.1076||95.0|-0.014|0.143|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.143|-0.014|0.1076
72594150|NCT00793624|144719751|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.058|STANDARD_ERROR_OF_MEAN|0.04||0.1492||95.0|-0.021|0.137|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.137|-0.021|0.1492
72594151|NCT00793624|144719752|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.083|STANDARD_ERROR_OF_MEAN|0.04||0.0385||95.0|0.004|0.162|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.162|0.004|0.0385
72594152|NCT00793624|144719752|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.059|STANDARD_ERROR_OF_MEAN|0.04||0.142||95.0|-0.02|0.138|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.138|-0.020|0.1420
72594153|NCT00793624|144719752|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.067|STANDARD_ERROR_OF_MEAN|0.04||0.0965||95.0|-0.012|0.147|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.147|-0.012|0.0965
72594154|NCT00793624|144719753|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.059|STANDARD_ERROR_OF_MEAN|0.04||0.1394||95.0|-0.019|0.138|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.138|-0.019|0.1394
72594155|NCT00793624|144719753|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.058|STANDARD_ERROR_OF_MEAN|0.04||0.1532||95.0|-0.022|0.137|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.137|-0.022|0.1532
72594156|NCT00793624|144719753|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.024|STANDARD_ERROR_OF_MEAN|0.041||0.5511||95.0|-0.055|0.104|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.104|-0.055|0.5511
72594157|NCT00793624|144719754|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.186|STANDARD_ERROR_OF_MEAN|0.04|<|0.0001||95.0|0.108|0.264|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.264|0.108|<0.0001
72594158|NCT00793624|144719754|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.206|STANDARD_ERROR_OF_MEAN|0.04|<|0.0001||95.0|0.128|0.284|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.284|0.128|<0.0001
72594159|NCT00793624|144719754|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.283|STANDARD_ERROR_OF_MEAN|0.04|<|0.0001||95.0|0.205|0.361|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.361|0.205|<0.0001
72594160|NCT00793624|144719755|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.209|STANDARD_ERROR_OF_MEAN|0.04|<|0.0001||95.0|0.131|0.288|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.288|0.131|<0.0001
72594161|NCT00793624|144719755|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.231|STANDARD_ERROR_OF_MEAN|0.04|<|0.0001||95.0|0.153|0.31|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.310|0.153|<0.0001
72594162|NCT00793624|144719755|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.265|STANDARD_ERROR_OF_MEAN|0.04|<|0.0001||95.0|0.187|0.344|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.344|0.187|<0.0001
72594163|NCT00793624|144719756|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.188|STANDARD_ERROR_OF_MEAN|0.04|<|0.0001||95.0|0.108|0.267|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.267|0.108|<0.0001
72594164|NCT00793624|144719756|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.238|STANDARD_ERROR_OF_MEAN|0.041|<|0.0001||95.0|0.159|0.318|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.318|0.159|<0.0001
72594165|NCT00793624|144719756|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.256|STANDARD_ERROR_OF_MEAN|0.041|<|0.0001||95.0|0.177|0.336|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.336|0.177|<0.0001
72594166|NCT00793624|144719757|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.173|STANDARD_ERROR_OF_MEAN|0.041|<|0.0001||95.0|0.092|0.253|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.253|0.092|<0.0001
72594167|NCT00793624|144719757|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.207|STANDARD_ERROR_OF_MEAN|0.041|<|0.0001||95.0|0.127|0.288|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.288|0.127|<0.0001
72594168|NCT00793624|144719757|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.217|STANDARD_ERROR_OF_MEAN|0.041|<|0.0001||95.0|0.137|0.298|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.298|0.137|<0.0001
72594169|NCT00793624|144719758|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.15|STANDARD_ERROR_OF_MEAN|0.041||0.0003||95.0|0.07|0.231|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.231|0.070|0.0003
72594170|NCT00793624|144719758|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.178|STANDARD_ERROR_OF_MEAN|0.041|<|0.0001||95.0|0.096|0.259|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.259|0.096|<0.0001
72594171|NCT00793624|144719758|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.223|STANDARD_ERROR_OF_MEAN|0.042|<|0.0001||95.0|0.141|0.304|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.304|0.141|<0.0001
72594172|NCT00793624|144719759|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|15.067|STANDARD_ERROR_OF_MEAN|4.639||0.0012|TWO_SIDED|95.0|5.962|24.173|||ANCOVA|non-MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.||Comparison for Weekly mean morning PEFR||24.173|5.962|0.0012
72594173|NCT00793624|144719759|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.999|STANDARD_ERROR_OF_MEAN|4.611||0.0012||95.0|5.949|24.049|||ANCOVA|non-MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.||Comparison for Weekly mean morning PEFR||24.049|5.949|0.0012
72594174|NCT00793624|144719759|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|17.642|STANDARD_ERROR_OF_MEAN|4.601||0.0001|TWO_SIDED|95.0|8.61|26.673|||ANCOVA|non-MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.||Comparison for Weekly mean morning PEFR||26.673|8.610|0.0001
72594175|NCT00793624|144719759|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|17.721|STANDARD_ERROR_OF_MEAN|4.606||0.0001|TWO_SIDED|95.0|8.68|26.762|||ANCOVA|non-MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.||Comparison for Weekly mean evening PEFR||26.762|8.680|0.0001
72594176|NCT00793624|144719759|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|18.471|STANDARD_ERROR_OF_MEAN|4.579|<|0.0001|TWO_SIDED|95.0|9.484|27.458|||ANCOVA|non-MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.||Comparison for Weekly mean evening PEFR||27.458|9.484|<0.0001
72594177|NCT00793624|144719759|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|17.873|STANDARD_ERROR_OF_MEAN|4.548|<|0.0001|TWO_SIDED|95.0|8.947|26.799|||ANCOVA|non-MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.||Comparison for Weekly mean evening PEFR||26.799|8.947|<0.0001
72594178|NCT00793624|144719760|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.403|STANDARD_ERROR_OF_MEAN|0.133||0.0026|TWO_SIDED|95.0|-0.665|-0.141|||ANCOVA|non-MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.||Comparison for weekly mean daytime rescue use||-0.141|-0.665|0.0026
72594179|NCT00793624|144719760|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.327|STANDARD_ERROR_OF_MEAN|0.133||0.0141|TWO_SIDED|95.0|-0.587|-0.066|||ANCOVA|non-MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.||Comparison for weekly mean daytime rescue use||-0.066|-0.587|0.0141
72594180|NCT00793624|144719760|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.147|STANDARD_ERROR_OF_MEAN|0.132||0.2677|TWO_SIDED|95.0|-0.406|0.113|||ANCOVA|non-MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.||Comparison for weekly mean daytime rescue use||0.113|-0.406|0.2677
72594181|NCT00793624|144719760|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.602|STANDARD_ERROR_OF_MEAN|0.171||0.0005|TWO_SIDED|95.0|-0.939|-0.266|||ANCOVA|non-MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.||Comparison for weekly mean nighttime rescue use||-0.266|-0.939|0.0005
72594182|NCT00793624|144719760|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.58|STANDARD_ERROR_OF_MEAN|0.17||0.0007|TWO_SIDED|95.0|-0.914|-0.247|||ANCOVA|non-MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.||Comparison for weekly mean nighttime rescue use||-0.247|-0.914|0.0007
72594183|NCT00793624|144719760|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.35|STANDARD_ERROR_OF_MEAN|0.169||0.0391|TWO_SIDED|95.0|-0.683|-0.018|||ANCOVA|non-MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.||Comparison for weekly mean nighttime rescue use||-0.018|-0.683|0.0391
72594184|NCT00793624|144719760|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.991|STANDARD_ERROR_OF_MEAN|0.269||0.0002|TWO_SIDED|95.0|-1.518|-0.464|||ANCOVA|non-MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.||Comparison for weekly mean daily (24h) rescue use||-0.464|-1.518|0.0002
72594185|NCT00793624|144719760|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.902|STANDARD_ERROR_OF_MEAN|0.267||0.0008|TWO_SIDED|95.0|-1.426|-0.378|||ANCOVA|non-MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.||Comparison for weekly mean daily (24h) rescue use||-0.378|-1.426|0.0008
72594186|NCT00793624|144719760|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.473|STANDARD_ERROR_OF_MEAN|0.266||0.0758|TWO_SIDED|95.0|-0.994|0.049|||ANCOVA|non-MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.||Comparison for weekly mean daily (24h) rescue use||0.049|-0.994|0.0758
72594187|NCT00793624|144719761|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.1||0.0003||95.0|-0.6|-0.2|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects, patient as random effect|Olo 5 mcg qd minus Placebo|||-0.2|-0.6|0.0003
72594188|NCT00793624|144719761|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.1||0.0073||95.0|-0.5|-0.1|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects, patient as random effect|Olo 10 mcg qd minus Placebo|||-0.1|-0.5|0.0073
72594189|NCT00793624|144719761|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.1||0.0017||95.0|-0.5|-0.1|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects, patient as random effect|Form 12 mcg minus Placebo|||-0.1|-0.5|0.0017
72594190|NCT00793624|144719762|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.1||0.0021||95.0|-0.5|-0.1|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects, patient as random effect|Olo 5 mcg qd minus Placebo|||-0.1|-0.5|0.0021
72594191|NCT00793624|144719762|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001||95.0|-0.6|-0.2|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects, patient as random effect|Olo 10 mcg qd minus Placebo|||-0.2|-0.6|<0.0001
72594192|NCT00793624|144719762|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.1||0.0121||95.0|-0.5|-0.1|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects, patient as random effect|Form 12 mcg minus Placebo|||-0.1|-0.5|0.0121
72594193|NCT00793624|144719763|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.1||0.032||95.0|-0.4|0.0|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects, patient as random effect|Olo 5 mcg qd minus Placebo|||-0.0|-0.4|0.0320
72594194|NCT00793624|144719763|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.1||0.0447||95.0|-0.4|0.0|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects, patient as random effect|Olo 10 mcg qd minus Placebo|||-0.0|-0.4|0.0447
72594195|NCT00793624|144719763|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.1||0.1332||95.0|-0.4|0.0|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects, patient as random effect|Form 12 mcg minus Placebo|||0.0|-0.4|0.1332
72594196|NCT00793624|144719764|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.1||0.4105||95.0|-0.3|0.1|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects, patient as random effect|Olo 5 mcg qd minus Placebo|||0.1|-0.3|0.4105
72594197|NCT00793624|144719764|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.1||0.0584||95.0|-0.4|0.0|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects, patient as random effect|Olo 10 mcg qd minus Placebo|||0.0|-0.4|0.0584
72594198|NCT00793624|144719764|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.1||0.1006||95.0|-0.4|0.0|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects, patient as random effect|Form 12 mcg minus Placebo|||0.0|-0.4|0.1006
72594199|NCT00793624|144719765|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.571|STANDARD_ERROR_OF_MEAN|0.335||0.0882||95.0|-0.085|1.227|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||1.227|-0.085|0.0882
72594200|NCT00793624|144719765|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.664|STANDARD_ERROR_OF_MEAN|0.336||0.0484||95.0|0.005|1.324|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||1.324|0.005|0.0484
72594201|NCT00793624|144719765|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.758|STANDARD_ERROR_OF_MEAN|0.338||0.0252||95.0|0.094|1.421|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||1.421|0.094|0.0252
72594202|NCT00793624|144719766|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.381|STANDARD_ERROR_OF_MEAN|0.34||0.2625||95.0|-0.285|1.047|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||1.047|-0.285|0.2625
72594203|NCT00793624|144719766|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.543|STANDARD_ERROR_OF_MEAN|0.341||0.1109||95.0|-0.125|1.211|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||1.211|-0.125|0.1109
72594204|NCT00793624|144719766|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.394|STANDARD_ERROR_OF_MEAN|0.343||0.2507||95.0|-0.278|1.066|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||1.066|-0.278|0.2507
72594205|NCT00793624|144719767|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.232|STANDARD_ERROR_OF_MEAN|0.342||0.4895||95.0|-0.439|0.902|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.902|-0.439|0.4895
72594206|NCT00793624|144719767|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.434|STANDARD_ERROR_OF_MEAN|0.344||0.2073||95.0|-0.24|1.107|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||1.107|-0.240|0.2073
72594207|NCT00793624|144719767|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.023|STANDARD_ERROR_OF_MEAN|0.345||0.9462||95.0|-0.653|0.7|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.700|-0.653|0.9462
72594208|NCT00793624|144719768|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.166|STANDARD_ERROR_OF_MEAN|0.345||0.6309||95.0|-0.511|0.842|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.842|-0.511|0.6309
72594209|NCT00793624|144719768|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.034|STANDARD_ERROR_OF_MEAN|0.348||0.9227||95.0|-0.717|0.649|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.649|-0.717|0.9227
72594210|NCT00793624|144719768|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.234|STANDARD_ERROR_OF_MEAN|0.349||0.503||95.0|-0.451|0.919|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.919|-0.451|0.5030
72594211|NCT00793624|144719769|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.112|STANDARD_ERROR_OF_MEAN|0.347||0.7459||95.0|-0.793|0.568|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.568|-0.793|0.7459
72594212|NCT00793624|144719769|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.065|STANDARD_ERROR_OF_MEAN|0.351||0.8534||95.0|-0.753|0.623|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.623|-0.753|0.8534
72594213|NCT00793624|144719769|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.377|STANDARD_ERROR_OF_MEAN|0.352||0.5099||95.0|-1.068|0.314|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.314|-1.068|0.5099
72594214|NCT00793624|144719770|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.095|STANDARD_ERROR_OF_MEAN|0.348||0.785||95.0|-0.587|0.777|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.777|-0.587|0.7850
72594215|NCT00793624|144719770|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.383|STANDARD_ERROR_OF_MEAN|0.352||0.2755||95.0|-0.306|1.073|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||1.073|-0.306|0.2755
72594216|NCT00793624|144719770|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.107|STANDARD_ERROR_OF_MEAN|0.353||0.7618||95.0|-0.584|0.798|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.798|-0.584|0.7618
72594217|NCT00793624|144719771|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.162|STANDARD_ERROR_OF_MEAN|0.19||0.3424||95.0|0.843|1.603|||Log Rank|Model included a stratification factor for tiotropium use stratum and a covariate for treatment group|Comparison of Olo 5 mcg qd to placebo across stratum|||1.603|0.843|0.3424
72594218|NCT00793624|144719771|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.186|STANDARD_ERROR_OF_MEAN|0.195||0.3023||95.0|0.859|1.636|||Log Rank|Model included a stratification factor for tiotropium use stratum and a covariate for treatment group|Comparison of Olo 10 mcg qd to placebo across stratum|||1.636|0.859|0.3023
72594219|NCT00793624|144719771|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.854|STANDARD_ERROR_OF_MEAN|0.15||0.3589||95.0|0.605|1.205|||Log Rank|Model included a stratification factor for tiotropium use stratum and a covariate for treatment group|Comparison of Form 12 mcg to placebo across stratum|||1.205|0.605|0.3589
72594220|NCT00793624|144719772|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.818|STANDARD_ERROR_OF_MEAN|0.841||0.191||95.0|0.734|4.503|||Log Rank|Model included a stratification factor for tiotropium use stratum and a covariate for treatment group|Comparison of Olo 5 mcg qd to placebo across stratum|||4.503|0.734|0.1910
72594221|NCT00793624|144719772|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.743|STANDARD_ERROR_OF_MEAN|0.817||0.2274||95.0|0.695|4.369|||Log Rank|Model included a stratification factor for tiotropium use stratum and a covariate for treatment group|Comparison of Olo 10 mcg qd to placebo across stratum|||4.369|0.695|0.2274
72594222|NCT00793624|144719772|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.346|STANDARD_ERROR_OF_MEAN|0.664||0.5538||95.0|0.512|3.538|||Log Rank|Model included a stratification factor for tiotropium use stratum and a covariate for treatment group|Comparison of Form 12 mcg to placebo across stratum|||3.538|0.512|0.5538
72594223|NCT00793624|144719773|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.101|STANDARD_ERROR_OF_MEAN|0.195||0.5577||95.0|0.778|1.557|||Log Rank|Model included a stratification factor for tiotropium use stratum and a covariate for treatment group|Comparison of Olo 5 mcg qd to placebo across stratum|||1.557|0.778|0.5577
72594224|NCT00793624|144719773|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.017|STANDARD_ERROR_OF_MEAN|0.184||0.9423||95.0|0.714|1.448|||Log Rank|Model included a stratification factor for tiotropium use stratum and a covariate for treatment group|Comparison of Olo 10 mcg qd to placebo across stratum|||1.448|0.714|0.9423
72594225|NCT00793624|144719773|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.735|STANDARD_ERROR_OF_MEAN|0.143||0.1097||95.0|0.502|1.076|||Log Rank|Model included a stratification factor for tiotropium use stratum and a covariate for treatment group|Comparison of Form 12 mcg to placebo across stratum|||1.076|0.502|0.1097
72594226|NCT00793624|144719774|SUPERIORITY_OR_OTHER||Incidence rate ratio|1.2521|STANDARD_ERROR_OF_MEAN|0.2064||0.1729||95.0|0.906|1.7304|||Negative binomial regression|Regression of treatment effect using tiotropium strata as a covariate, a log link function and log(exposure) as offset.|Olo 5 mcg qd minus Placebo|||1.7304|0.9060|0.1729
72594227|NCT00793624|144719774|SUPERIORITY_OR_OTHER||Incidence rate ratio|1.222|STANDARD_ERROR_OF_MEAN|0.2039||0.2297||95.0|0.8808|1.6954|||Negative binomial regression|Regression of treatment effect using tiotropium strata as a covariate, a log link function and log(exposure) as offset.|Olo 10 mcg qd minus Placebo|||1.6954|0.8808|0.2297
72594228|NCT00793624|144719774|SUPERIORITY_OR_OTHER||Incidence rate ratio|0.8968|STANDARD_ERROR_OF_MEAN|0.1575||0.5354||95.0|0.6353|1.2659|||Negative binomial regression|Regression of treatment effect using tiotropium strata as a covariate, a log link function and log(exposure) as offset.|Form 12 mcg minus Placebo|||1.2659|0.6353|0.5354
72594229|NCT00793624|144719775|SUPERIORITY_OR_OTHER||Incidence rate ratio|1.8821|STANDARD_ERROR_OF_MEAN|1.0358||0.2508||95.0|0.6391|5.543|||Negative binomial regression|Regression of treatment effect using tiotropium strata as a covariate, a log link function and log(exposure) as offset.|Olo 5 mcg qd minus Placebo|||5.5430|0.6391|0.2508
72594230|NCT00793624|144719775|SUPERIORITY_OR_OTHER||Incidence rate ratio|2.3877|STANDARD_ERROR_OF_MEAN|1.3119||0.1135||95.0|0.8122|7.0194|||Negative binomial regression|Regression of treatment effect using tiotropium strata as a covariate, a log link function and log(exposure) as offset.|Olo 10 mcg qd minus Placebo|||7.0194|0.8122|0.1135
72594231|NCT00793624|144719775|SUPERIORITY_OR_OTHER||Incidence rate ratio|1.0289|STANDARD_ERROR_OF_MEAN|0.6013||0.9611||95.0|0.3268|3.2395|||Negative binomial regression|Regression of treatment effect using tiotropium strata as a covariate, a log link function and log(exposure) as offset.|Form 12 mcg minus Placebo|||3.2395|0.3268|0.9611
72594232|NCT00793624|144719776|SUPERIORITY_OR_OTHER||Incidence rate ratio|1.1621|STANDARD_ERROR_OF_MEAN|0.2075||0.4002||95.0|0.8187|1.6497|||Negative binomial regression|Regression of treatment effect using tiotropium strata as a covariate, a log link function and log(exposure) as offset.|Olo 5 mcg qd minus Placebo|||1.6497|0.8187|0.4002
72594233|NCT00793624|144719776|SUPERIORITY_OR_OTHER||Incidence rate ratio|1.0733|STANDARD_ERROR_OF_MEAN|0.1957||0.6983||95.0|0.7503|1.5352|||Negative binomial regression|Regression of treatment effect using tiotropium strata as a covariate, a log link function and log(exposure) as offset.|Olo 10 mcg qd minus Placebo|||1.5352|0.7503|0.6983
72594234|NCT00793624|144719776|SUPERIORITY_OR_OTHER||Incidence rate ratio|0.781|STANDARD_ERROR_OF_MEAN|0.1516||0.2033||95.0|0.5336|1.1433|||Negative binomial regression|Regression of treatment effect using tiotropium strata as a covariate, a log link function and log(exposure) as offset.|Form 12 mcg minus Placebo|||1.1433|0.5336|0.2033
72594235|NCT00793624|144719779|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.509|STANDARD_ERROR_OF_MEAN|0.23||0.027||95.0|0.058|0.96|||pattern mixture model|See Hogan, et. al. Hogan JW, Roy J, Korkontzelou C Tutorial in biostatistics:handling drop-out in longitudinal studies. Stat Med 23,1455-1497(2004)|"Based on a pattern mixture model with four patterns based on time of dropout (i.e., day of last observed data)~1\) day 43 or day 85, 2) day 127 or day 169, 3) day 225 or day 281, 4) day 337"|Olo 5mcg minus placebo||0.960|0.058|0.0270
72594236|NCT00793624|144719779|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.525|STANDARD_ERROR_OF_MEAN|0.226||0.0203||95.0|0.082|0.967||See Hogan, et. al. Hogan JW, Roy J, Korkontzelou C Tutorial in biostatistics:handling drop-out in longitudinal studies. Stat Med 23,1455-1497(2004)|pattern mixture model||"Based on a pattern mixture model with four patterns based on time of dropout (i.e., day of last observed data)~1\) day 43 or day 85, 2) day 127 or day 169, 3) day 225 or day 281, 4) day 337"|Olo 10 mcg minus placebo||0.967|0.082|0.0203
72594237|NCT00793624|144719779|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.355|STANDARD_ERROR_OF_MEAN|0.226||0.1166||95.0|-0.088|0.799|||pattern mixture model|See Hogan, et. al. Hogan JW, Roy J, Korkontzelou C Tutorial in biostatistics:handling drop-out in longitudinal studies. Stat Med 23,1455-1497(2004)|"Based on a pattern mixture model with four patterns based on time of dropout (i.e., day of last observed data)~1\) day 43 or day 85, 2) day 127 or day 169, 3) day 225 or day 281, 4) day 337"|Form 12mcg minus placebo||0.799|-0.088|0.1166
72594238|NCT00710684|144719780|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.7||||0.279|TWO_SIDED|95.0|-1.9|0.5|||mixed model for repeated measures (MMRM)|The MMRM model included fixed categorical terms for treatment, visit, treatment by visit interaction and country.||SB-742457 15mg versus placebo at Week 24||0.5|-1.9|0.279
72594239|NCT00710684|144719780|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.5||||0.012|TWO_SIDED|95.0|-2.7|-0.3|||MMRM|The MMRM model included fixed categorical terms for treatment, visit, treatment by visit interaction and country.||SB-742457 35mg versus placebo at Week 24||-0.3|-2.7|0.012
72594240|NCT00710684|144719781|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1||||0.711|TWO_SIDED|95.0|-0.4|0.3|||MMRM|The MMRM model included fixed categorical terms for treatment, visit, treatment by visit interaction and country.||SB-742457 15 mg versus placebo at Week 24||0.3|-0.4|0.711
72594241|NCT00710684|144719781|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1||||0.462|TWO_SIDED|95.0|-0.5|0.2|||MMRM|The MMRM model included fixed categorical terms for treatment, visit, treatment by visit interaction and country.||SB-742457 35 mg versus placebo at Week 24||0.2|-0.5|0.462
72594242|NCT00710684|144719782|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.4||||0.174|TWO_SIDED|95.0|-5.8|1.1|||MMRM|The MMRM model included fixed categorical terms for treatment, visit, treatment by visit interaction and country.||SB-742457 15 mg versus placebo at Week 24||1.1|-5.8|0.174
72594243|NCT00710684|144719782|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.5||||0.776|TWO_SIDED|95.0|-3.6|2.7|||MMRM|The MMRM model included fixed categorical terms for treatment, visit, treatment by visit interaction and country.||SB-742457 35 mg versus placebo at Week 24||2.7|-3.6|0.776
72594244|NCT00710684|144719783|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.2||||0.631|TWO_SIDED|95.0|-1.2|0.7|||MMRM|The MMRM model included fixed categorical terms for treatment, visit, treatment by visit interaction and country.||SB-742457 15 mg versus placebo at Week 12||0.7|-1.2|0.631
72594245|NCT00710684|144719783|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.3||||0.006|TWO_SIDED|95.0|-2.2|-0.4|||MMRM|The MMRM model included fixed categorical terms for treatment, visit, treatment by visit interaction and country.||SB-742457 35 mg versus placebo at Week 12||-0.4|-2.2|0.006
72594246|NCT00710684|144719783|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0||||0.947|TWO_SIDED|95.0|-1.3|1.2|||MMRM|The MMRM model included fixed categorical terms for treatment, visit, treatment by visit interaction and country.||SB-742457 15 mg versus placebo at Week 36||1.2|-1.3|0.947
72594247|NCT00710684|144719783|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.2||||0.057|TWO_SIDED|95.0|-2.5|0.0|||MMRM|The MMRM model included fixed categorical terms for treatment, visit, treatment by visit interaction and country.||SB-742457 35 mg versus placebo at Week 36||0.0|-2.5|0.057
72594248|NCT00710684|144719783|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1||||0.925|TWO_SIDED|95.0|-1.6|1.5|||MMRM|The MMRM model included fixed categorical terms for treatment, visit, treatment by visit interaction and country.||SB-742457 15 mg versus placebo at Week 48||1.5|-1.6|0.925
72594249|NCT00710684|144719783|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.6||||0.024|TWO_SIDED|95.0|-3.1|-0.2|||MMRM|The MMRM model included fixed categorical terms for treatment, visit, treatment by visit interaction and country.||SB-742457 35 mg versus placebo at Week 48||-0.2|-3.1|0.024
72594250|NCT00710684|144719784|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1||||0.387|TWO_SIDED|95.0|-0.4|0.1|||MMRM|The MMRM model included fixed categorical terms for treatment, visit, treatment by visit interaction and country.||SB-742457 15 mg versus placebo at Week 12||0.1|-0.4|0.387
72594251|NCT00710684|144719784|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.3||||0.018|TWO_SIDED|95.0|-0.5|-0.1|||MMRM|||SB-742457 35 mg versus placebo at Week 12||-0.1|-0.5|0.018
72594252|NCT00710684|144719784|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.2||||0.439|TWO_SIDED|95.0|-0.3|0.6|||MMRM|The MMRM model included fixed categorical terms for treatment, visit, treatment by visit interaction and country.||SB-742457 15 mg versus placebo at Week 36||0.6|-0.3|0.439
72594253|NCT00710684|144719784|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.2||||0.336|TWO_SIDED|95.0|-0.6|0.2|||MMRM|The MMRM model included fixed categorical terms for treatment, visit, treatment by visit interaction and country.||SB-742457 35 mg versus placebo at Week 36||0.2|-0.6|0.336
72594254|NCT00710684|144719784|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.3||||0.19|TWO_SIDED|95.0|-0.2|0.8|||MMRM|The MMRM model included fixed categorical terms for treatment, visit, treatment by visit interaction and country.||SB-742457 15 mg versus placebo at Week 48||0.8|-0.2|0.190
72594255|NCT00710684|144719784|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1||||0.787|TWO_SIDED|95.0|-0.5|0.4|||MMRM|The MMRM model included fixed categorical terms for treatment, visit, treatment by visit interaction and country.||SB-742457 35 mg versus placebo at Week 48||0.4|-0.5|0.787
72594256|NCT00710684|144719785|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.3||||0.337|TWO_SIDED|95.0|-4.0|1.4|||MMRM|The MMRM model included fixed categorical terms for treatment, visit, treatment by visit interaction and country.||SB-742457 15 mg versus placebo at Week 12||1.4|-4.0|0.337
72594257|NCT00710684|144719785|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.6||||0.596|TWO_SIDED|95.0|-1.7|3.0|||MMRM|The MMRM model included fixed categorical terms for treatment, visit, treatment by visit interaction and country.||SB-742457 35 mg versus placebo at Week 12||3.0|-1.7|0.596
72594258|NCT00710684|144719785|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.9||||0.634|TWO_SIDED|95.0|-4.4|2.7|||MMRM|The MMRM model included fixed categorical terms for treatment, visit, treatment by visit interaction and country.||SB-742457 15 mg versus placebo at Week 36||2.7|-4.4|0.634
72594259|NCT00710684|144719785|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.1||||0.238|TWO_SIDED|95.0|-1.4|5.6|||MMRM|The MMRM model included fixed categorical terms for treatment, visit, treatment by visit interaction and country.||SB-742457 35 mg versus placebo at Week 36||5.6|-1.4|0.238
72414970|NCT01571362|144339994|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.16|STANDARD_ERROR_OF_MEAN|1.091||0.2898|TWO_SIDED|95.0|-3.3|0.99||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|ANCOVA|||Difference between treatment groups in change from Randomization Baseline for Vitality.||0.99|-3.30|0.2898
72414971|NCT01571362|144339994|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.48|STANDARD_ERROR_OF_MEAN|1.044||0.1565|TWO_SIDED|95.0|-0.57|3.54||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|ANCOVA|||Difference between treatment groups in change from Randomization Baseline for Social Functioning.||3.54|-0.57|0.1565
72414972|NCT01571362|144339994|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.86|STANDARD_ERROR_OF_MEAN|1.348||0.522|TWO_SIDED|95.0|-3.52|1.79||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|ANCOVA|||Difference between treatment groups in change from Randomization Baseline for Role-Emotional.||1.79|-3.52|0.5220
72414973|NCT01571362|144339994|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.02|STANDARD_ERROR_OF_MEAN|0.995||0.9865|TWO_SIDED|95.0|-1.94|1.98||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|ANCOVA|||Difference between treatment groups in change from Randomization Baseline for Mental Health.||1.98|-1.94|0.9865
72414974|NCT01571362|144339994|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.02|STANDARD_ERROR_OF_MEAN|0.885||0.2491|TWO_SIDED|95.0|-0.72|2.77||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|ANCOVA|||Difference between treatment groups in change from Randomization Baseline for Physical Component Score.||2.77|-0.72|0.2491
72594260|NCT00710684|144719785|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.1||||0.292|TWO_SIDED|95.0|-6.0|1.8|||MMRM|The MMRM model included fixed categorical terms for treatment, visit, treatment by visit interaction and country.||SB-742457 15 mg versus placebo at Week 48||1.8|-6.0|0.292
72594261|NCT00710684|144719785|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.6||||0.161|TWO_SIDED|95.0|-1.0|6.2|||MMRM|The MMRM model included fixed categorical terms for treatment, visit, treatment by visit interaction and country.||SB-742457 35 mg versus placebo at Week 48||6.2|-1.0|0.161
72594262|NCT00710684|144719786|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.6||||0.396|TWO_SIDED|95.0|-0.8|2.1|||MMRM|The MMRM model included fixed categorical terms for treatment, visit, treatment by visit interaction and country.||SB-742457 15 mg versus placebo at Week 12||2.1|-0.8|0.396
72594263|NCT00710684|144719786|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.7||||0.019|TWO_SIDED|95.0|0.3|3.2|||MMRM|The MMRM model included fixed categorical terms for treatment, visit, treatment by visit interaction and country.||SB-742457 35 mg versus placebo at Week 12||3.2|0.3|0.019
72594264|NCT00710684|144719786|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.4||||0.11|TWO_SIDED|95.0|-0.3|3.2|||MMRM|The MMRM model included fixed categorical terms for treatment, visit, treatment by visit interaction and country.||SB-742457 15 mg versus placebo at Week 24||3.2|-0.3|0.110
72594265|NCT00710684|144719786|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.0||||0.024|TWO_SIDED|95.0|0.3|3.7|||MMRM|The MMRM model included fixed categorical terms for treatment, visit, treatment by visit interaction and country.||SB-742457 35 mg versus placebo at Week 24||3.7|0.3|0.024
72594266|NCT00710684|144719786|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1||||0.944|TWO_SIDED|95.0|-2.1|2.0|||MMRM|The MMRM model included fixed categorical terms for treatment, visit, treatment by visit interaction and country.||SB-742457 15 mg versus placebo ate Week 36||2.0|-2.1|0.944
72594267|NCT00710684|144719786|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.9||||0.037|TWO_SIDED|95.0|0.1|3.8|||MMRM|The MMRM model included fixed categorical terms for treatment, visit, treatment by visit interaction and country.||SB-742457 35 mg versus placebo at Week 36||3.8|0.1|0.037
72594268|NCT00710684|144719786|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.5||||0.705|TWO_SIDED|95.0|-1.9|2.9|||MMRM|The MMRM model included fixed categorical terms for treatment, visit, treatment by visit interaction and country.||SB-742457 15 mg versus placebo at Week 48||2.9|-1.9|0.705
72594269|NCT00710684|144719786|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.9||||0.088|TWO_SIDED|95.0|-0.3|4.2|||MMRM|The MMRM model included fixed categorical terms for treatment, visit, treatment by visit interaction and country.||SB-742457 35 mg versus placebo at Week 48||4.2|-0.3|0.088
72594270|NCT00710684|144719787|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0||||0.962|TWO_SIDED|95.0|-0.6|0.6|||MMRM|The MMRM model included fixed categorical terms for treatment, visit, treatment by visit interaction and country.||SB-742457 15 mg versus placebo at Week 24||0.6|-0.6|0.962
72594271|NCT00710684|144719787|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.4||||0.134|TWO_SIDED|95.0|-0.1|1.0|||MMRM|The MMRM model included fixed categorical terms for treatment, visit, treatment by visit interaction and country.||SB-742457 35 mg versus placebo at Week 24||1.0|-0.1|0.134
72594272|NCT00710684|144719787|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1||||0.782|TWO_SIDED|95.0|-1.0|0.7|||MMRM|The MMRM model included fixed categorical terms for treatment, visit, treatment by visit interaction and country.||SB-742457 15 mg versus placebo at Week 48||0.7|-1.0|0.782
72594273|NCT00710684|144719787|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.4||||0.268|TWO_SIDED|95.0|-0.3|1.2|||MMRM|The MMRM model included fixed categorical terms for treatment, visit, treatment by visit interaction and country.||SB-742457 35 mg versus placebo at Week 48||1.2|-0.3|0.268
72594274|NCT02987972|144719821|NON_INFERIORITY|Statistical criterion for non-inferiority corresponds to the lower bound of the adjusted 95% CI of the proportion difference (V114 minus Prevnar 13™) being greater than -0.15 for each of the 13 shared serotypes.|Difference in Percentages|-0.1|||<|0.001|TWO_SIDED|95.0|-3.3|3.0|||Miettinen and Nurminen||Difference in Response Rate calculated as Percentage V114 Lot 1 minus Percentage Prevnar 13™|Type 1||3.0|-3.3|< 0.001
72594275|NCT02987972|144719821|NON_INFERIORITY|Statistical criterion for non-inferiority corresponds to the lower bound of the adjusted 95% CI of the proportion difference (V114 minus Prevnar 13™) being greater than -0.15 for each of the 13 shared serotypes.|Difference in Percentages|24.2|||<|0.001|TWO_SIDED|95.0|18.7|30.0|||Miettinen and Nurminen||Difference in Response Rate calculated as Percentage V114 Lot 1 minus Percentage Prevnar|Type 3||30.0|18.7|< 0.001
72594276|NCT02987972|144719821|NON_INFERIORITY|Statistical criterion for non-inferiority corresponds to the lower bound of the adjusted 95% CI of the proportion difference (V114 minus Prevnar 13™) being greater than -0.15 for each of the 13 shared serotypes.|Difference in Percentages|3.0|||<|0.001|TWO_SIDED|95.0|0.0|6.4|||Miettinen and Nurminen||Difference in Response Rate calculated as Percentage V114 Lot 1 minus Percentage Prevnar 13™|Type 4||6.4|0.0|< 0.001
72594277|NCT02987972|144719821|NON_INFERIORITY|Statistical criterion for non-inferiority corresponds to the lower bound of the adjusted 95% CI of the proportion difference (V114 minus Prevnar 13™) being greater than -0.15 for each of the 13 shared serotypes.|Difference in Percentages|-0.5|||<|0.001|TWO_SIDED|95.0|-3.9|2.8|||Miettinen and Nurminen||Difference in Response Rate calculated as Percentage V114 Lot 1 minus Percentage Prevnar 13™|Type 5||2.8|-3.9|< 0.001
72594278|NCT02987972|144719821|NON_INFERIORITY|Statistical criterion for non-inferiority corresponds to the lower bound of the adjusted 95% CI of the proportion difference (V114 minus Prevnar 13™) being greater than -0.15 for each of the 13 shared serotypes.|Difference in Percentages|-5.6|||<|0.001|TWO_SIDED|95.0|-10.0|-1.6|||Miettinen and Nurminen||Difference in Response Rate calculated as Percentage V114 Lot 1 minus Percentage Prevnar 13™|Type 6A||-1.6|-10.0|< 0.001
72594279|NCT02987972|144719821|NON_INFERIORITY|Statistical criterion for non-inferiority corresponds to the lower bound of the adjusted 95% CI of the proportion difference (V114 minus Prevnar 13™) being greater than -0.15 for each of the 13 shared serotypes.|Difference in Percentages|-0.8|||<|0.001|TWO_SIDED|95.0|-5.7|4.0|||Miettinen and Nurminen||Difference in Response Rate calculated as Percentage V114 Lot 1 minus Percentage Prevnar 13™|Type 6B||4.0|-5.7|< 0.001
72414975|NCT01571362|144339994|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.69|STANDARD_ERROR_OF_MEAN|1.073||0.5219|TWO_SIDED|95.0|-2.8|1.43||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|ANCOVA|||Difference between treatment groups in change from Randomization Baseline for Mental Component Score.||1.43|-2.80|0.5219
72414976|NCT01571362|144339995|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.52|STANDARD_ERROR_OF_MEAN|1.111||0.1731|TWO_SIDED|95.0|-0.67|3.71||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariates.|ANCOVA|||Difference between treatment groups in change from Screening for Physical Functioning.||3.71|-0.67|0.1731
72414977|NCT01571362|144339995|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.1|STANDARD_ERROR_OF_MEAN|1.127||0.329|TWO_SIDED|95.0|-1.12|3.32||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariates.|ANCOVA|||Difference between treatment groups in change from Screening for Role-Physical.||3.32|-1.12|0.3290
72414978|NCT01571362|144339995|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.39|STANDARD_ERROR_OF_MEAN|1.047||0.0232|TWO_SIDED|95.0|0.33|4.45||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariates.|ANCOVA|||Difference between treatment groups in change from Screening for Bodily Pain.||4.45|0.33|0.0232
72414979|NCT01571362|144339995|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.2|STANDARD_ERROR_OF_MEAN|0.858||0.8139|TWO_SIDED|95.0|-1.89|1.49||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariates.|ANCOVA|||Difference between treatment groups in change from Screening for General Health Perceptions.||1.49|-1.89|0.8139
72414980|NCT01571362|144339995|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.45|STANDARD_ERROR_OF_MEAN|1.117||0.6878|TWO_SIDED|95.0|-2.65|1.75||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariates.|ANCOVA|||Difference between treatment groups in change from Screening for Vitality.||1.75|-2.65|0.6878
72594280|NCT02987972|144719821|NON_INFERIORITY|Statistical criterion for non-inferiority corresponds to the lower bound of the adjusted 95% CI of the proportion difference (V114 minus Prevnar 13™) being greater than -0.15 for each of the 13 shared serotypes.|Difference in Percentages|0.7|||<|0.001|TWO_SIDED|95.0|-1.1|2.7|||Miettinen and Nurminen||Difference in Response Rate calculated as Percentage V114 Lot 1 minus Percentage Prevnar 13™|Type 7F||2.7|-1.1|< 0.001
72594281|NCT02987972|144719821|NON_INFERIORITY|Statistical criterion for non-inferiority corresponds to the lower bound of the adjusted 95% CI of the proportion difference (V114 minus Prevnar 13™) being greater than -0.15 for each of the 13 shared serotypes.|Difference in Percentages|1.3|||<|0.001|TWO_SIDED|95.0|-1.9|4.6|||Miettinen and Nurminen||Difference in Response Rate calculated as Percentage V114 Lot 1 minus Percentage Prevnar 13™|Type 9V||4.6|-1.9|< 0.001
72414981|NCT01571362|144339995|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.0|STANDARD_ERROR_OF_MEAN|1.08||0.0658|TWO_SIDED|95.0|-0.13|4.12||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariates.|ANCOVA|||Difference between treatment groups in change from Screening for Social Functioning.||4.12|-0.13|0.0658
72594282|NCT02987972|144719821|NON_INFERIORITY|Statistical criterion for non-inferiority corresponds to the lower bound of the adjusted 95% CI of the proportion difference (V114 minus Prevnar 13™) being greater than -0.15 for each of the 13 shared serotypes.|Difference in Percentages|2.0|||<|0.001|TWO_SIDED|95.0|-0.2|4.7|||Miettinen and Nurminen||Difference in Response Rate calculated as Percentage V114 Lot 1 minus Percentage Prevnar 13™|Type 14||4.7|-0.2|< 0.001
72594283|NCT02987972|144719821|NON_INFERIORITY|Statistical criterion for non-inferiority corresponds to the lower bound of the adjusted 95% CI of the proportion difference (V114 minus Prevnar 13™) being greater than -0.15 for each of the 13 shared serotypes.|Difference in Percentages|1.2|||<|0.001|TWO_SIDED|95.0|-2.1|4.7|||Miettinen and Nurminen||Difference in Response Rate calculated as Percentage V114 Lot 1 minus Percentage Prevnar 13™|Type 18C||4.7|-2.1|< 0.001
72594284|NCT02987972|144719821|NON_INFERIORITY|Statistical criterion for non-inferiority corresponds to the lower bound of the adjusted 95% CI of the proportion difference (V114 minus Prevnar 13™) being greater than -0.15 for each of the 13 shared serotypes.|Difference in Percentages|0.3|||<|0.001|TWO_SIDED|95.0|-1.9|2.6|||Miettinen and Nurminen||Difference in Response Rate calculated as Percentage V114 Lot 1 minus Percentage Prevnar 13™|Type 19A||2.6|-1.9|< 0.001
72594285|NCT02987972|144719821|NON_INFERIORITY|Statistical criterion for non-inferiority corresponds to the lower bound of the adjusted 95% CI of the proportion difference (V114 minus Prevnar 13™) being greater than -0.15 for each of the 13 shared serotypes.|Difference in Percentages|0.3|||<|0.001|TWO_SIDED|95.0|-1.0|1.9|||Miettinen and Nurminen||Difference in Response Rate calculated as Percentage V114 Lot 1 minus Percentage Prevnar 13™|Type 19F||1.9|-1.0|< 0.001
72594286|NCT02987972|144719821|NON_INFERIORITY|Statistical criterion for non-inferiority corresponds to the lower bound of the adjusted 95% CI of the proportion difference (V114 minus Prevnar 13™) being greater than -0.15 for each of the 13 shared serotypes.|Difference in Percentages|1.8|||<|0.001|TWO_SIDED|95.0|-2.9|6.5|||Miettinen and Nurminen||Difference in Response Rate calculated as Percentage V114 Lot 1 minus Percentage Prevnar 13™|Type 23F||6.5|-2.9|< 0.001
72594287|NCT02987972|144719821|NON_INFERIORITY|Statistical criterion for non-inferiority corresponds to the lower bound of the adjusted 95% CI of the proportion difference (V114 minus Prevnar 13™) being greater than -0.15 for each of the 13 shared serotypes.|Difference in Percentages|0.9|||<|0.001|TWO_SIDED|95.0|-2.0|3.9|||Miettinen and Nurminen||Difference in Response Rate calculated as Percentage V114 Lot 2 minus Percentage Prevnar 13™|Type 1||3.9|-2.0|< 0.001
72594288|NCT02987972|144719821|NON_INFERIORITY|Statistical criterion for non-inferiority corresponds to the lower bound of the adjusted 95% CI of the proportion difference (V114 minus Prevnar 13™) being greater than -0.15 for each of the 13 shared serotypes.|Difference in Percentages|22.3|||<|0.001|TWO_SIDED|95.0|16.5|28.3|||Miettinen and Nurminen||Difference in Response Rate calculated as Percentage V114 Lot 2 minus Percentage Prevnar 13™|Type 3||28.3|16.5|< 0.001
72594289|NCT02987972|144719821|NON_INFERIORITY|Statistical criterion for non-inferiority corresponds to the lower bound of the adjusted 95% CI of the proportion difference (V114 minus Prevnar 13™) being greater than -0.15 for each of the 13 shared serotypes.|Difference in Percentages|1.9|||<|0.001|TWO_SIDED|95.0|-1.4|5.4|||Miettinen and Nurminen||Difference in Response Rate calculated as Percentage V114 Lot 2 minus Percentage Prevnar 13™|Type 4||5.4|-1.4|< 0.001
72594290|NCT02987972|144719821|NON_INFERIORITY|Statistical criterion for non-inferiority corresponds to the lower bound of the adjusted 95% CI of the proportion difference (V114 minus Prevnar 13™) being greater than -0.15 for each of the 13 shared serotypes.|Difference in Percentages|-0.6|||<|0.001|TWO_SIDED|95.0|-4.1|2.7|||Miettinen and Nurminen||Difference in Response Rate calculated as Percentage V114 Lot 2 minus Percentage Prevnar 13™|Type 5||2.7|-4.1|< 0.001
72594291|NCT02987972|144719821|NON_INFERIORITY|Statistical criterion for non-inferiority corresponds to the lower bound of the adjusted 95% CI of the proportion difference (V114 minus Prevnar 13™) being greater than -0.15 for each of the 13 shared serotypes.|Difference in Percentages|-0.6|||<|0.001|TWO_SIDED|95.0|-4.2|2.8|||Miettinen and Nurminen||Difference in Response Rate calculated as Percentage V114 Lot 2 minus Percentage Prevnar 13™|Type 6A||2.8|-4.2|< 0.001
72594292|NCT02987972|144719821|NON_INFERIORITY|Statistical criterion for non-inferiority corresponds to the lower bound of the adjusted 95% CI of the proportion difference (V114 minus Prevnar 13™) being greater than -0.15 for each of the 13 shared serotypes.|Difference in Percentages|0.9|||<|0.001|TWO_SIDED|95.0|-3.7|5.6|||Miettinen and Nurminen||Difference in Response Rate calculated as Percentage V114 Lot 2 minus Percentage Prevnar 13™|Type 6B||5.6|-3.7|< 0.001
72594293|NCT02987972|144719821|NON_INFERIORITY|Statistical criterion for non-inferiority corresponds to the lower bound of the adjusted 95% CI of the proportion difference (V114 minus Prevnar 13™) being greater than -0.15 for each of the 13 shared serotypes.|Difference in Percentages|0.3|||<|0.001|TWO_SIDED|95.0|-1.7|2.4|||Miettinen and Nurminen||Difference in Response Rate calculated as Percentage V114 Lot 2 minus Percentage Prevnar 13™|Type 7F||2.4|-1.7|< 0.001
72594294|NCT02987972|144719821|NON_INFERIORITY|Statistical criterion for non-inferiority corresponds to the lower bound of the adjusted 95% CI of the proportion difference (V114 minus Prevnar 13™) being greater than -0.15 for each of the 13 shared serotypes.|Difference in Percentages|2.0|||<|0.001|TWO_SIDED|95.0|-1.1|5.2|||Miettinen and Nurminen||Difference in Response Rate calculated as Percentage V114 Lot 2 minus Percentage Prevnar 13™|Type 9V||5.2|-1.1|< 0.001
72594295|NCT02987972|144719821|NON_INFERIORITY|Statistical criterion for non-inferiority corresponds to the lower bound of the adjusted 95% CI of the proportion difference (V114 minus Prevnar 13™) being greater than -0.15 for each of the 13 shared serotypes.|Difference in Percentages|0.2|||<|0.001|TWO_SIDED|95.0|-2.8|3.1|||Miettinen and Nurminen||Difference in Response Rate calculated as Percentage V114 Lot 2 minus Percentage Prevnar 13™|Type 14||3.1|-2.8|< 0.001
72594296|NCT02987972|144719821|NON_INFERIORITY|Statistical criterion for non-inferiority corresponds to the lower bound of the adjusted 95% CI of the proportion difference (V114 minus Prevnar 13™) being greater than -0.15 for each of the 13 shared serotypes.|Difference in Percentages|2.6|||<|0.001|TWO_SIDED|95.0|-0.3|5.9|||Miettinen and Nurminen||Difference in Response Rate calculated as Percentage V114 Lot 2 minus Percentage Prevnar 13™|Type 18C||5.9|-0.3|< 0.001
72594297|NCT02987972|144719821|NON_INFERIORITY|Statistical criterion for non-inferiority corresponds to the lower bound of the adjusted 95% CI of the proportion difference (V114 minus Prevnar 13™) being greater than -0.15 for each of the 13 shared serotypes.|Difference in Percentages|-0.1|||<|0.001|TWO_SIDED|95.0|-2.5|2.2|||Miettinen and Nurminen||Difference in Response Rate calculated as Percentage V114 Lot 2 minus Percentage Prevnar 13™|Type 19A||2.2|-2.5|< 0.001
72594298|NCT02987972|144719821|NON_INFERIORITY|Statistical criterion for non-inferiority corresponds to the lower bound of the adjusted 95% CI of the proportion difference (V114 minus Prevnar 13™) being greater than -0.15 for each of the 13 shared serotypes.|Difference in Percentages|-0.8|||<|0.001|TWO_SIDED|95.0|-2.9|0.9|||Miettinen and Nurminen||Difference in Response Rate calculated as Percentage V114 Lot 2 minus Percentage Prevnar 13™|Type 19F||0.9|-2.9|< 0.001
72594299|NCT02987972|144719821|NON_INFERIORITY|Statistical criterion for non-inferiority corresponds to the lower bound of the adjusted 95% CI of the proportion difference (V114 minus Prevnar 13™) being greater than -0.15 for each of the 13 shared serotypes.|Difference in Percentages|4.2|||<|0.001|TWO_SIDED|95.0|-0.1|8.7|||Miettinen and Nurminen||Difference in Response Rate calculated as Percentage V114 Lot 2 minus Percentage Prevnar 13™|Type 23F||8.7|-0.1|< 0.001
72594300|NCT02987972|144719822|OTHER||GMC Ratio|0.72|||||TWO_SIDED|95.0|0.64|0.81|||||IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on analysis of variance (ANOVA) model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 1||0.81|0.64|
72594301|NCT02987972|144719822|OTHER||GMC Ratio|1.98|||||TWO_SIDED|95.0|1.75|2.23|||||IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 3||2.23|1.75|
72594302|NCT02987972|144719822|OTHER||GMC Ratio|1.04|||||TWO_SIDED|95.0|0.92|1.16|||||IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 4||1.16|0.92|
72594303|NCT02987972|144719822|OTHER||GMC Ratio|0.78|||||TWO_SIDED|95.0|0.68|0.89|||||IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 5||0.89|0.68|
72594304|NCT02987972|144719822|OTHER||GMC Ratio|0.54|||||TWO_SIDED|95.0|0.47|0.63|||||IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 6A||0.63|0.47|
72594305|NCT02987972|144719822|OTHER||GMC Ratio|1.03|||||TWO_SIDED|95.0|0.84|1.26|||||IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 6B||1.26|0.84|
72594306|NCT02987972|144719822|OTHER||GMC Ratio|0.82|||||TWO_SIDED|95.0|0.73|0.92|||||IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 7F||0.92|0.73|
72594307|NCT02987972|144719822|OTHER||GMC Ratio|0.88|||||TWO_SIDED|95.0|0.77|1.0|||||IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 9V||1.00|0.77|
72594308|NCT02987972|144719822|OTHER||GMC Ratio|0.88|||||TWO_SIDED|95.0|0.75|1.03|||||IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 14||1.03|0.75|
72594309|NCT02987972|144719822|OTHER||GMC Ratio|0.75|||||TWO_SIDED|95.0|0.66|0.84|||||IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 18C||0.84|0.66|
72594310|NCT02987972|144719822|OTHER||GMC Ratio|0.82|||||TWO_SIDED|95.0|0.73|0.92|||||IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 19A||0.92|0.73|
72594311|NCT02987972|144719822|OTHER||GMC Ratio|0.88|||||TWO_SIDED|95.0|0.79|0.98|||||IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on analysis of variance (ANOVA) model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 19F||0.98|0.79|
72594312|NCT02987972|144719822|OTHER||GMC Ratio|0.98|||||TWO_SIDED|95.0|0.84|1.13|||||IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 23F||1.13|0.84|
72594313|NCT02987972|144719822|OTHER||GMC Ratio|92.05|||||TWO_SIDED|95.0|80.84|104.81|||||IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 22F||104.81|80.84|
72594314|NCT02987972|144719822|OTHER||GMC Ratio|34.41|||||TWO_SIDED|95.0|28.5|41.54|||||IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 33F||41.54|28.50|
72594315|NCT02987972|144719822|OTHER||GMC Ratio|0.83|||||TWO_SIDED|95.0|0.74|0.94|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 1||0.94|0.74|
72594316|NCT02987972|144719822|OTHER||GMC Ratio|1.93|||||TWO_SIDED|95.0|1.71|2.18|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 3||2.18|1.71|
72594317|NCT02987972|144719822|OTHER||GMC Ratio|1.01|||||TWO_SIDED|95.0|0.9|1.14|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 4||1.14|0.90|
72594318|NCT02987972|144719822|OTHER||GMC Ratio|0.83|||||TWO_SIDED|95.0|0.72|0.94|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 5||0.94|0.72|
72594319|NCT02987972|144719822|OTHER||GMC Ratio|0.57|||||TWO_SIDED|95.0|0.49|0.66|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 6A||0.66|0.49|
72594320|NCT02987972|144719822|OTHER||GMC Ratio|0.9|||||TWO_SIDED|95.0|0.74|1.1|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 6B||1.10|0.74|
72594321|NCT02987972|144719822|OTHER||GMC Ratio|0.81|||||TWO_SIDED|95.0|0.72|0.91|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 7F||0.91|0.72|
72594322|NCT02987972|144719822|OTHER||GMC Ratio|1.07|||||TWO_SIDED|95.0|0.94|1.22|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 9V||1.22|0.94|
72594323|NCT02987972|144719822|OTHER||GMC Ratio|0.83|||||TWO_SIDED|95.0|0.71|0.97|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 14||0.97|0.71|
72594324|NCT02987972|144719822|OTHER||GMC Ratio|0.99|||||TWO_SIDED|95.0|0.88|1.12|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 18C||1.12|0.88|
72594325|NCT02987972|144719822|OTHER||GMC Ratio|0.82|||||TWO_SIDED|95.0|0.73|0.92|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 19A||0.92|0.73|
72594326|NCT02987972|144719822|OTHER||GMC Ratio|0.91|||||TWO_SIDED|95.0|0.81|1.01|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 19F||1.01|0.81|
72594327|NCT02987972|144719822|OTHER||GMC Ratio|1.18|||||TWO_SIDED|95.0|1.01|1.37|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 23F||1.37|1.01|
72594328|NCT02987972|144719822|OTHER||GMC Ratio|80.09|||||TWO_SIDED|95.0|70.3|91.24|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 22F||91.24|70.30|
72594329|NCT02987972|144719822|OTHER||GMC Ratio|32.92|||||TWO_SIDED|95.0|27.25|39.78|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 33F||39.78|27.25|
72594330|NCT02987972|144719823|OTHER||Difference in Percentages|0.0|||||TWO_SIDED|95.0|-3.1|3.2||||||Difference in percentages calculated as V114 Lot 1 minus Prevnar 13™. Confidence intervals based on Miettinen and Nurminen method.||3.2|-3.1|
72594331|NCT02987972|144719823|OTHER||Difference in Percentages|2.0|||||TWO_SIDED|95.0|-0.7|5.0||||||Difference in percentages calculated as V114 Lot 2 minus Prevnar 13™. Confidence intervals based on Miettinen and Nurminen method.||5.0|-0.7|
72594332|NCT02987972|144719824|OTHER||Difference in Percentages|0.3|||||TWO_SIDED|95.0|-0.8|1.6||||||Difference in percentages calculated as V114 Lot 1 minus Prevnar 13™. Confidence intervals based on Miettinen and Nurminen method.||1.6|-0.8|
72594333|NCT02987972|144719824|OTHER||Difference in Percentages|0.3|||||TWO_SIDED|95.0|-0.8|1.6||||||Difference in percentages calculated as V114 Lot 2 minus Prevnar 13™. Confidence intervals based on Miettinen and Nurminen method.||1.6|-0.8|
72594334|NCT02987972|144719825|OTHER||Difference in Percentages|6.3|||||TWO_SIDED|95.0|-0.3|12.8|||||Difference in percentages calculated as V114 Lot 1 minus Prevnar 13™.|||12.8|-0.3|
72594335|NCT02987972|144719825|OTHER||Difference in Percentages|6.3|||||TWO_SIDED|95.0|-0.2|12.9|||||Difference in percentages calculated as V114 Lot 2 minus Prevnar 13™.|||12.9|-0.2|
72594336|NCT02987972|144719826|OTHER||Difference in Percentages|0.7||||0.772|TWO_SIDED|95.0|-3.9|5.2|||Miettinen and Nurminen||Difference in percentages calculated as V114 Lot 1 minus Prevnar 13™.|||5.2|-3.9|0.772
72594337|NCT02987972|144719826|OTHER||Difference in Percentages|2.6||||0.235|TWO_SIDED|95.0|-1.7|7.0|||Miettinen and Nurminen||Difference in percentages calculated as V114 Lot 2 minus Prevnar 13™.|||7.0|-1.7|0.235
72594338|NCT02987972|144719827|OTHER||GMC Ratio|0.69|||||TWO_SIDED|95.0|0.62|0.76|||||IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 1||0.76|0.62|
72594339|NCT02987972|144719827|OTHER||GMC Ratio|2.0|||||TWO_SIDED|95.0|1.75|2.28|||||IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 3||2.28|1.75|
72594340|NCT02987972|144719827|OTHER||GMC Ratio|0.96|||||TWO_SIDED|95.0|0.86|1.07|||||IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 4||1.07|0.86|
72594341|NCT02987972|144719827|OTHER||GMC Ratio|0.87|||||TWO_SIDED|95.0|0.78|0.96|||||IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 5||0.96|0.78|
72594342|NCT02987972|144719827|OTHER||GMC Ratio|0.57|||||TWO_SIDED|95.0|0.5|0.65|||||IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 6A||0.65|0.50|
72594343|NCT02987972|144719827|OTHER||GMC Ratio|1.21|||||TWO_SIDED|95.0|1.06|1.39|||||IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 6B||1.39|1.06|
72594344|NCT02987972|144719827|OTHER||GMC Ratio|0.74|||||TWO_SIDED|95.0|0.67|0.82|||||IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 7F||0.82|0.67|
72594345|NCT02987972|144719827|OTHER||GMC Ratio|0.84|||||TWO_SIDED|95.0|0.74|0.95|||||IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 9V||0.95|0.74|
72594346|NCT02987972|144719827|OTHER||GMC Ratio|0.66|||||TWO_SIDED|95.0|0.58|0.76|||||IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 14||0.76|0.58|
72594347|NCT02987972|144719827|OTHER||GMC Ratio|0.8|||||TWO_SIDED|95.0|0.72|0.9||||||Type 18C|IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|0.90|0.72|
72594348|NCT02987972|144719827|OTHER||GMC Ratio|0.79|||||TWO_SIDED|95.0|0.69|0.91|||||IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 19A||0.91|0.69|
72594349|NCT02987972|144719827|OTHER||GMC Ratio|0.74|||||TWO_SIDED|95.0|0.65|0.85|||||IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 19F||0.85|0.65|
72594350|NCT02987972|144719827|OTHER||GMC Ratio|0.92|||||TWO_SIDED|95.0|0.79|1.07|||||IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 23F||1.07|0.79|
72594351|NCT02987972|144719827|OTHER||GMC Ratio|27.82|||||TWO_SIDED|95.0|24.64|31.4|||||IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|type 22F||31.40|24.64|
72594352|NCT02987972|144719827|OTHER||GMC Ratio|25.57|||||TWO_SIDED|95.0|22.61|28.92|||||IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 33F||28.92|22.61|
72594353|NCT02987972|144719827|OTHER||GMC ratio|0.77|||||TWO_SIDED|95.0|0.69|0.85|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 1||0.85|0.69|
72594354|NCT02987972|144719827|OTHER||GMC Ratio|2.1|||||TWO_SIDED|95.0|1.84|2.39|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 3||2.39|1.84|
72594355|NCT02987972|144719827|OTHER||GMC Ratio|0.94|||||TWO_SIDED|95.0|0.85|1.05|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 4||1.05|0.85|
72594356|NCT02987972|144719827|OTHER||GMC Ratio|0.86|||||TWO_SIDED|95.0|0.77|0.95|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 5||0.95|0.77|
72594357|NCT02987972|144719827|OTHER||GMC Ratio|0.65|||||TWO_SIDED|95.0|0.57|0.74|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 6A||0.74|0.57|
72594358|NCT02987972|144719827|OTHER||GMC Ratio|1.12|||||TWO_SIDED|95.0|0.97|1.28|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 6B||1.28|0.97|
72594359|NCT02987972|144719827|OTHER||GMC Ratio|0.78|||||TWO_SIDED|95.0|0.7|0.86|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 7F||0.86|0.70|
72594360|NCT02987972|144719827|OTHER||GMC Ratio|0.86|||||TWO_SIDED|95.0|0.76|0.97|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 9V||0.97|0.76|
72594361|NCT02987972|144719827|OTHER||GMC Ratio|0.61|||||TWO_SIDED|95.0|0.53|0.7|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 14||0.70|0.53|
72594362|NCT02987972|144719827|OTHER||GMC Ratio|1.2|||||TWO_SIDED|95.0|1.07|1.34|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 18C||1.34|1.07|
72594363|NCT02987972|144719827|OTHER||GMC Ratio|0.82|||||TWO_SIDED|95.0|0.71|0.94|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 19A||0.94|0.71|
72594364|NCT02987972|144719827|OTHER||GMC Ratio|0.83|||||TWO_SIDED|95.0|0.73|0.94|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 19F||0.94|0.73|
72414982|NCT01571362|144339995|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.23|STANDARD_ERROR_OF_MEAN|1.374||0.867|TWO_SIDED|95.0|-2.48|2.94||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariates.|ANCOVA|||Difference between treatment groups in change from Screening for Role-Emotional.||2.94|-2.48|0.8670
72594365|NCT02987972|144719827|OTHER||GMC Ratio|1.16|||||TWO_SIDED|95.0|0.99|1.35|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 23F||1.35|0.99|
72414983|NCT01571362|144339995|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.37|STANDARD_ERROR_OF_MEAN|1.056||0.7259|TWO_SIDED|95.0|-1.71|2.45||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariates.|ANCOVA|||Difference between treatment groups in change from Screening for Mental Health.||2.45|-1.71|0.7259
72594366|NCT02987972|144719827|OTHER||GMC Ratio|26.3|||||TWO_SIDED|95.0|23.31|29.68|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 22F||29.68|23.31|
72594367|NCT02987972|144719827|OTHER||GMC Ratio|24.1|||||TWO_SIDED|95.0|21.32|27.25|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 33F||27.25|21.32|
72594368|NCT02987972|144719828|OTHER||GMC Ratio|0.71|||||TWO_SIDED|95.0|0.62|0.81|||||IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 1||0.81|0.62|
72594369|NCT02987972|144719828|OTHER||GMC Ratio|1.44|||||TWO_SIDED|95.0|1.27|1.63|||||IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 3||1.63|1.27|
72594370|NCT02987972|144719828|OTHER||GMC Ratio|0.88|||||TWO_SIDED|95.0|0.76|1.02|||||IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 4||1.02|0.76|
72594371|NCT02987972|144719828|OTHER||GMC Ratio|0.73|||||TWO_SIDED|95.0|0.63|0.84|||||IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 5||0.84|0.63|
72594372|NCT02987972|144719828|OTHER||GMC Ratio|0.72|||||TWO_SIDED|95.0|0.62|0.82|||||IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 6A||0.82|0.62|
72594373|NCT02987972|144719828|OTHER||GMC Ratio|1.07|||||TWO_SIDED|95.0|0.93|1.22|||||IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 6B||1.22|0.93|
72594374|NCT02987972|144719828|OTHER||GMC Ratio|0.67|||||TWO_SIDED|95.0|0.59|0.77|||||IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 7F||0.77|0.59|
72414984|NCT01571362|144339995|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.67|STANDARD_ERROR_OF_MEAN|1.007||0.0989|TWO_SIDED|95.0|-0.32|3.65||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariates.|ANCOVA|||Difference between treatment groups in change from Screening for Physical Component Score.||3.65|-0.32|0.0989
72594375|NCT02987972|144719828|OTHER||GMC Ratio|0.69|||||TWO_SIDED|95.0|0.6|0.79|||||IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 9V||0.79|0.60|
72594376|NCT02987972|144719828|OTHER||GMC Ratio|0.88|||||TWO_SIDED|95.0|0.76|1.02|||||IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 14||1.02|0.76|
72594377|NCT02987972|144719828|OTHER||GMC Ratio|0.93|||||TWO_SIDED|95.0|0.81|1.08|||||IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 18C||1.08|0.81|
72594378|NCT02987972|144719828|OTHER||GMC Ratio|0.89|||||TWO_SIDED|95.0|0.78|1.01|||||IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 19A||1.01|0.78|
72594379|NCT02987972|144719828|OTHER||GMC Ratio|0.97|||||TWO_SIDED|95.0|0.85|1.1|||||IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 19F||1.10|0.85|
72594380|NCT02987972|144719828|OTHER||GMC Ratio|0.75|||||TWO_SIDED|95.0|0.64|0.87|||||IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 23F||0.87|0.64|
72594381|NCT02987972|144719828|OTHER||GMC Ratio|149.69|||||TWO_SIDED|95.0|130.23|172.06|||||IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 22F||172.06|130.23|
72594382|NCT02987972|144719828|OTHER||GMC Ratio|90.35|||||TWO_SIDED|95.0|79.93|102.12|||||IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 33F||102.12|79.93|
72594383|NCT02987972|144719828|OTHER||GMC Ratio|0.81|||||TWO_SIDED|95.0|0.71|0.93|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 1||0.93|0.71|
72594384|NCT02987972|144719828|OTHER||GMC Ratio|1.48|||||TWO_SIDED|95.0|1.31|1.68|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 3||1.68|1.31|
72594385|NCT02987972|144719828|OTHER||GMC Ratio|0.81|||||TWO_SIDED|95.0|0.7|0.94|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 4||0.94|0.70|
72594386|NCT02987972|144719828|OTHER||GMC Ratio|0.69|||||TWO_SIDED|95.0|0.6|0.79|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 5||0.79|0.60|
72594387|NCT02987972|144719828|OTHER||GMC Ratio|0.66|||||TWO_SIDED|95.0|0.58|0.76|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 6A||0.76|0.58|
72594388|NCT02987972|144719828|OTHER||GMC Ratio|0.83|||||TWO_SIDED|95.0|0.72|0.95|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 6B||0.95|0.72|
72594389|NCT02987972|144719828|OTHER||GMC Ratio|0.71|||||TWO_SIDED|95.0|0.62|0.81|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 7F||0.81|0.62|
72594390|NCT02987972|144719828|OTHER||GMC Ratio|0.77|||||TWO_SIDED|95.0|0.67|0.88|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 9V||0.88|0.67|
72594391|NCT02987972|144719828|OTHER||GMC Ratio|0.85|||||TWO_SIDED|95.0|0.73|0.98|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 14||0.98|0.73|
72594392|NCT02987972|144719828|OTHER||GMC Ratio|1.07|||||TWO_SIDED|95.0|0.93|1.24|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 18C||1.24|0.93|
72594393|NCT02987972|144719828|OTHER||GMC Ratio|0.82|||||TWO_SIDED|95.0|0.72|0.93|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 19A||0.93|0.72|
72594394|NCT02987972|144719828|OTHER||GMC Ratio|0.9|||||TWO_SIDED|95.0|0.79|1.03|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 19F||1.03|0.79|
72594395|NCT02987972|144719828|OTHER||GMC Ratio|0.92|||||TWO_SIDED|95.0|0.79|1.08|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 23F||1.08|0.79|
72594396|NCT02987972|144719828|OTHER||GMC Ratio|131.23|||||TWO_SIDED|95.0|114.05|151.0|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 22F||151.00|114.05|
72594397|NCT02987972|144719828|OTHER||GMC Ratio|78.99|||||TWO_SIDED|95.0|69.82|89.36|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 33F||89.36|69.82|
72594398|NCT05072106|144719844|OTHER|Bioequivalence|Least-squares geometric mean ratio|96.83|||||TWO_SIDED|90.0|81.09|115.62|||||The reported results are the same as the ones reported in the CSR of the trial.|||115.62|81.09|
72594399|NCT05072106|144719845|OTHER|Bioequivalence|Least-squares geometric mean ratio|79.81|||||TWO_SIDED|90.0|64.78|98.32||||||||98.32|64.78|
72594400|NCT05072106|144719846|OTHER|Bioequivalence|Least-squares geometric mean ratio|79.2|||||TWO_SIDED|90.0|64.12|97.82||||||||97.82|64.12|
72594401|NCT05072106|144719847|OTHER|Bioequivalence|Least-squares geometric mean ratio|125.3|||||TWO_SIDED|90.0|101.71|154.36||||||||154.36|101.71|
72594402|NCT05072106|144719848|OTHER|Bioequivalence|Least-squares geometric mean ratio|106.79|||||TWO_SIDED|90.0|74.63|152.8||||||||152.8|74.63|
72594403|NCT05072106|144719849|OTHER|Bioequivalence|Least-squares geometric mean ratio|104.93|||||TWO_SIDED|90.0|69.49|158.44||||||||158.44|69.49|
72594404|NCT05072106|144719850|OTHER|bioequivalence|Least-squares geometric mean ratio|88.44|||||TWO_SIDED|90.0|65.62|119.19||||||||119.19|65.62|
72594405|NCT05072106|144719851|OTHER|bioequivalence|Least-squares geometric mean ratio|81.8|||||TWO_SIDED|90.0|54.8|119.96||||||||119.96|54.8|
72594406|NCT05072106|144719852|OTHER|bioequivalence|Least-squares geometric mean ratio|80.26|||||TWO_SIDED|90.0|54.26|118.72||||||||118.72|54.26|
72594407|NCT05072106|144719853|OTHER|bioequivalence|Least-squares geometric mean ratio|123.34|||||TWO_SIDED|90.0|83.36|182.49||||||||182.49|83.36|
72594408|NCT05072106|144719854|OTHER|bioequivalence|Least-squares geometric mean ratio|120.5|||||TWO_SIDED|90.0|64.79|224.13||||||||224.13|64.79|
72594409|NCT05072106|144719855|OTHER|bioequivalence|Least-squares geometric mean ratio|120.5|||||TWO_SIDED|90.0|64.79|224.13||||||||224.13|64.79|
72414985|NCT01571362|144339995|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|1.142||0.9969|TWO_SIDED|95.0|-2.25|2.25||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariates.|ANCOVA|||Difference between treatment groups in change from Screening for Mental Component Score.||2.25|-2.25|0.9969
72594410|NCT05072106|144719856|OTHER|bioequivalence|Least-squares geometric mean ratio|188.13|||||TWO_SIDED|90.0|132.93|266.26||||||PK parameter used was the log-transformed metabolite/parent ratio (MPR) of M1 dose-normalized Cmax.||266.26|132.93|
72594411|NCT05072106|144719857|OTHER|bioequivalence|Least-squares geometric mean ratio|245.46|||||TWO_SIDED|90.0|133.4|451.65||||||PK parameter used was the log-transformed metabolite/parent ratio (MPR) of M1 dose-normalized AUC0-t.||451.65|133.4|
72594412|NCT05072106|144719858|OTHER|bioequivalence|Least-squares geometric mean ratio|104.94|||||TWO_SIDED|90.0|94.07|117.05||||||PK parameter used was the log-transformed metabolite/parent ratio (MPR) of M4 dose-normalized Cmax.||117.05|94.07|
72594413|NCT05072106|144719859|OTHER|bioequivalence|Least-squares geometric mean ratio|91.02|||||TWO_SIDED|90.0|71.39|116.04||||||PK parameter used was the log-transformed metabolite/parent ratio (MPR) of M4 dose-normalized AUC0-t.||116.04|71.39|
72594414|NCT00310466|144719869|SUPERIORITY_OR_OTHER|||||||0.87||95.0|||||ANOVA|||||||0.87
72594415|NCT00310466|144719870|SUPERIORITY_OR_OTHER|||||||0.04||95.0|||||ANOVA|||||||0.04
72594416|NCT00310466|144719872|SUPERIORITY_OR_OTHER|||||||0.55||95.0|||||ANOVA|||||||0.55
72594417|NCT01458951|144719873|SUPERIORITY_OR_OTHER||Percentage difference|13.0||||0.0005|TWO_SIDED|95.0|8.1|17.9|||CMH Chi-square Test|||P-value based on Cochran-Mantel Haenszel (CMH) chi-square test stratified by prior treatment with anti-tumor necrosis factor (TNF), steroid use at baseline and geographic region. Percentage difference and its 95% CI was based on normal approximation for the difference in binomial proportions. Missing data were imputed using non-responder imputation (NRI).||17.9|8.1|0.0005
72594418|NCT01458951|144719874|SUPERIORITY_OR_OTHER||Percentage difference|16.8||||0.0002|TWO_SIDED|95.0|9.5|24.1|||CMH Chi-square Test|||P-value was based on CMH chi-square test stratified by prior treatment with anti-TNF, steroid use at baseline and geographic region. Percentage difference and its 95% CI was based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||24.1|9.5|0.0002
72594419|NCT01458951|144719875|SUPERIORITY_OR_OTHER||Percentage difference|26.4|||<|0.0001|TWO_SIDED|95.0|16.8|36.0|||CMH Chi-square Test|||P-value was based on CMH chi-square test stratified by prior treatment with anti-TNF, steroid use at baseline and geographic region. Percentage difference and its 95% CI was based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||36.0|16.8|<0.0001
72414986|NCT01571362|144339996|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
72414987|NCT01571362|144339997|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
72414988|NCT01571362|144339998|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
72414989|NCT01571362|144339999|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
72414990|NCT01571362|144340000|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.032|STANDARD_ERROR_OF_MEAN|0.0168||0.0605|TWO_SIDED|95.0|-0.001|0.065||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of study drug during the Titration Period as covariates.|ANCOVA|||||0.065|-0.001|0.0605
72414991|NCT01571362|144340001|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.72|STANDARD_ERROR_OF_MEAN|1.999||0.7196|TWO_SIDED|95.0|-3.22|4.66||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors; Randomization Baseline score and final total daily dose of study drug during the Titration Period as covariates.|ANCOVA|||||4.66|-3.22|0.7196
72594420|NCT01458951|144719876|SUPERIORITY_OR_OTHER||Percentage difference|5.2||||0.0425|TWO_SIDED|95.0|1.8|8.6|||CMH Chi-square Test|||P-value was based on CMH chi-square test stratified by prior treatment with anti-TNF, steroid use at baseline and geographic region. Percentage difference and its 95% CI was based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||8.6|1.8|0.0425
72594421|NCT01458951|144719877|SUPERIORITY_OR_OTHER||Difference in percentage|13.2||||0.0004|TWO_SIDED|95.0|8.3|18.1|||CMH Chi-square Test|||P-value was based on CMH chi-square test stratified by prior treatment with anti-TNF, steroid use at baseline and geographic region. Difference in its percentage and its 95% CI was based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||18.1|8.3|0.0004
72594422|NCT01458951|144719878|SUPERIORITY_OR_OTHER||Percentage difference|8.0||||0.009|TWO_SIDED|95.0|3.9|12.2|||CMH Chi-square Test|||P-value was based on CMH chi-square test stratified by prior treatment with anti-TNF, steroid use at baseline and geographic region. Percentage difference and its 95% CI was based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||12.2|3.9|0.0090
72594423|NCT01458951|144719879|SUPERIORITY_OR_OTHER||Percentage difference|3.3||||0.1408|TWO_SIDED|95.0|0.1|6.6|||CMH Chi-square Test|||P-value was based on CMH chi-square test stratified by prior treatment with anti-TNF, steroid use at baseline and geographic region. Percentage difference and its 95% CI was based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||6.6|0.1|0.1408
72594424|NCT01458951|144719881|SUPERIORITY_OR_OTHER||Least square mean difference|-1.0|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001|TWO_SIDED|95.0|-1.4|-0.6|||Mixed Models Analysis|||At Week 2: The change from baseline was analyzed using mixed effect model with treatment group, prior treatment with antiTNF, steroid use at baseline, geographic region, visit and visit by treatment group all as fixed effects, and subjects as a random effect.||-0.6|-1.4|<0.0001
72594425|NCT01458951|144719881|SUPERIORITY_OR_OTHER||Least square mean difference|-1.2|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001|TWO_SIDED|95.0|-1.6|-0.7|||Mixed Models Analysis|||At Week 4: The change from baseline was analyzed using mixed effect model with treatment group, prior treatment with antiTNF, steroid use at baseline, geographic region, visit and visit by treatment group all as fixed effects, and subjects as a random effect.||-0.7|-1.6|<0.0001
72594426|NCT01458951|144719881|SUPERIORITY_OR_OTHER||Least square mean difference|-1.3|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001|TWO_SIDED|95.0|-1.7|-0.9|||Mixed Models Analysis|||At Week 8: The change from baseline was analyzed using mixed effect model with treatment group, prior treatment with antiTNF, steroid use at baseline, geographic region, visit and visit by treatment group all as fixed effects, and subjects as a random effect.||-0.9|-1.7|<0.0001
72594427|NCT01458951|144719882|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-1.6|STANDARD_ERROR_OF_MEAN|0.3|<|0.0001|TWO_SIDED|95.0|-2.2|-1.0|||ANCOVA|||The change from baseline at Week 8 was analyzed using an analysis of covariance (ANCOVA) model with treatment group, prior treatment with anti-TNF, steroid use at baseline and geographic region as factors and baseline as a covariate based on the observed-case data.||-1.0|-2.2|<0.0001
72594428|NCT00585013|144719883|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||This p value applies to all time points for all variables.|Wilcoxon (Mann-Whitney)|||||||>0.05
72594429|NCT00585013|144719884|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||This applies for measurements at preoperative and 0 h time points.|Wilcoxon (Mann-Whitney)|||||||>0.05
72594430|NCT00585013|144719884|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|||||This applies to measurements at time points 12 h, 24 h, and 48 h.|Wilcoxon (Mann-Whitney)|||||||<0.05
72594431|NCT00585013|144719885|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||This applies to measurements at preoperative, 0 h, and 48 h time points.|Wilcoxon (Mann-Whitney)|||||||>0.05
72594432|NCT00585013|144719885|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|||||This applies to time points at 12 h and 24 h.|Wilcoxon (Mann-Whitney)|||||||<0.05
72594433|NCT00585013|144719886|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||Applies to all time points.|Wilcoxon (Mann-Whitney)|||||||>0.05
72414992|NCT01571362|144340002|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.021|STANDARD_ERROR_OF_MEAN|0.0172||0.228|TWO_SIDED|95.0|-0.013|0.055||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariate.|ANCOVA|||||0.055|-0.013|0.2280
72594434|NCT01573767|144719909|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.4||||0.227|TWO_SIDED|95.0|-2.7|11.4||Inference for VI 12.5 µg versus (vs) placebo was dependent upon statistical significance (SS) having first been achieved for VI 25 µg vs placebo; inference for VI 6.25 µg vs placebo was dependent on SS having been achieved for VI 12.5 µg vs placebo.|ANCOVA|||||11.4|-2.7|0.227
72594435|NCT01573767|144719909|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.4||||0.073|TWO_SIDED|95.0|-0.6|13.5|||ANCOVA|||||13.5|-0.6|0.073
72594436|NCT01573767|144719909|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.5||||0.127|TWO_SIDED|95.0|-1.6|12.5|||ANCOVA|||||12.5|-1.6|0.127
72414993|NCT01571362|144340003|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.26|STANDARD_ERROR_OF_MEAN|2.048||0.2701|TWO_SIDED|95.0|-1.77|6.3||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariate.|ANCOVA|||||6.30|-1.77|0.2701
72414994|NCT01571362|144340004|SUPERIORITY_OR_OTHER|||||||0.3822|||||||t-test, 2 sided|||Change from Screening Period value to End of Open-Label for % Work Time Missed due to Low Back Pain.||||0.3822
72414995|NCT01571362|144340004|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||Change from Screening Period value to End of Open-Label for % Impairment while Working due to Low Back Pain.||||<0.0001
72594437|NCT01573767|144719910|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.057|||||TWO_SIDED|95.0|-0.138|0.024||||||||0.024|-0.138|
72594438|NCT01573767|144719910|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.017|||||TWO_SIDED|95.0|-0.063|0.096||||||||0.096|-0.063|
72594439|NCT01573767|144719910|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.03|||||TWO_SIDED|95.0|-0.11|0.051||||||||0.051|-0.110|
72594440|NCT01573767|144719911|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.3|||||TWO_SIDED|95.0|-10.5|6.0||||||||6.0|-10.5|
72594441|NCT01573767|144719911|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.3|||||TWO_SIDED|95.0|-6.9|9.6||||||||9.6|-6.9|
72594442|NCT01573767|144719911|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.7|||||TWO_SIDED|95.0|0.4|17.0||||||||17.0|0.4|
72594443|NCT01573767|144719912|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.5|||||TWO_SIDED|95.0|-1.2|12.3||||||||12.3|-1.2|
72594444|NCT01573767|144719912|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.5|||||TWO_SIDED|95.0|0.7|14.2||||||||14.2|0.7|
72594445|NCT01573767|144719912|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.2||||||95.0|0.4|14.0||||||||14.0|0.4|
72594446|NCT01573767|144719913|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.5|||||TWO_SIDED|95.0|-6.1|13.1||||||||13.1|-6.1|
72594447|NCT01573767|144719913|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.8|||||TWO_SIDED|95.0|-1.8|17.4||||||||17.4|-1.8|
72594448|NCT01573767|144719913|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.2|||||TWO_SIDED|95.0|-4.4|14.9||||||||14.9|-4.4|
72594449|NCT01573767|144719914|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.9|||||TWO_SIDED|95.0|-3.7|15.6||||||||15.6|-3.7|
72594450|NCT01573767|144719914|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.7|||||TWO_SIDED|95.0|0.0|19.3||||||||19.3|0.0|
72594451|NCT01573767|144719914|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.0||||||95.0|-2.7|16.7||||||||16.7|-2.7|
72594452|NCT01573767|144719915|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2|||||TWO_SIDED|95.0|-7.2|7.5||||||||7.5|-7.2|
72594453|NCT01573767|144719915|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.3|||||TWO_SIDED|95.0|1.0|15.7||||||||15.7|1.0|
72594454|NCT01573767|144719915|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.8|||||TWO_SIDED|95.0|2.3|17.2||||||||17.2|2.3|
72414996|NCT01571362|144340004|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||Change from Screening Period value to End of Open-Label for % Overall Work Impairment due to Low Back Pain.||||<0.0001
72414997|NCT01571362|144340004|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||Change from Screening Period value to End of Open-Label for % Activity Impairment due to Low Back Pain.||||<0.0001
72414998|NCT01571362|144340005|SUPERIORITY_OR_OTHER|||||||0.0017|||||||t-test, 2 sided|||Change from Screening Period value to Randomization Baseline for % Work Time Missed due to Low Back Pain||||0.0017
72594458|NCT00869557|144719921|NON_INFERIORITY_OR_EQUIVALENCE|"A total sample size of 75 participants randomized in a 2:1 ratio had 26% power to evaluate noninferiority with respect to the response rate of HIV-1 RNA \< 50 copies/mL at Week 24 if a response rate of 84% for both treatment groups and a noninferiority margin of 0.12 were assumed.~A total of 71 participants were enrolled in the study (4 fewer than planned)."|Difference in the response rates (%)|2.8|||||TWO_SIDED|95.0|-14.5|20.1|||||The 95% confidence interval was computed using normal approximation stratified by baseline HIV-1 RNA stratum (≤ 100,000 or \> 100,000 copies/mL).|The null hypothesis was that the response rate (proportion of participants with HIV-1 RNA \< 50 copies/mL at Week 24) in the Stribild group was at least 12% worse than the response rate in Atripla group; the alternative hypothesis was that the response rate in the Stribild group was less than 12% worse than that in the Atripla group.||20.1|-14.5|
72594459|NCT02368210|144719927|SUPERIORITY||||||<|0.001||||||"Treatment groups were compared with respect to the proportions of subjects with treatment success at Day 15 using the Cochran-Mantel-Haenszel (CMH) test stratified by analysis center."|Cochran-Mantel-Haenszel|Missing data was imputed as treatment failure.||||||<0.001
72594460|NCT02368210|144719928|SUPERIORITY||||||<|0.001||||||The pre-specified threshold for statistical significance was ≤0.05. The reported P-Value applies to the clinical sign of psoriasis: Scaling.|Cochran-Mantel-Haenszel|Missing data was imputed as treatment failure.||Treatment groups were compared with respect to each of the clinical signs of psoriasis (scaling, erythema and plaque elevation).||||<0.001
72594461|NCT02368210|144719928|SUPERIORITY||||||<|0.001||||||The pre-specified threshold for statistical significance was ≤0.05. The reported P-Value applies to the clinical sign of psoriasis: erythema.|Cochran-Mantel-Haenszel|Missing data was imputed as treatment failure.||Treatment groups were compared with respect to each of the clinical signs of psoriasis (scaling, erythema and plaque elevation).||||<0.001
72414999|NCT01571362|144340005|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||Change from Screening Period value to Randomization Baseline for % Impairment while Working due to Low Back Pain||||<0.0001
72415000|NCT01571362|144340005|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||Change from Screening Period value to Randomization Baseline for % Overall Work Impairment due to Low Back Pain||||<0.0001
72415001|NCT01571362|144340005|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||Change from Screening Period value to Randomization Baseline for % Activity Impairment due to Low Back Pain||||<0.0001
72415002|NCT01571362|144340006|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.31|STANDARD_ERROR_OF_MEAN|2.883||0.1389|TWO_SIDED|95.0|-10.06|1.43||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|ANCOVA|||Week 4||1.43|-10.06|0.1389
72594462|NCT02368210|144719928|SUPERIORITY||||||<|0.001||||||The pre-specified threshold for statistical significance was ≤0.05. The reported P-Value applies to the clinical sign of psoriasis: Plaque Elevation.|Cochran-Mantel-Haenszel|Missing data was imputed as treatment failure.||Treatment groups were compared with respect to each of the clinical signs of psoriasis (scaling, erythema and plaque elevation).||||<0.001
72594463|NCT00078949|144719933|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The literature has suggested that the ORR is approximately 50% for this patient population treated with DHAP. The treatment difference is defined as the response rate for the DHAP arm minus that of GDP arm. We would consider GDP to be non-inferior to DHAP if we are 95% sure that the true difference is less than 10%. In order to rule out that the 10% difference with 80% power, we need to accrue a total of 630 eligible patients. The actual sample size for this final analysis is 619 patients.|Risk Difference (RD)|-1.2||||0.005|TWO_SIDED|95.0|-9.0|6.7||p-value for non-inferiority|Cochran-Mantel-Haenszel|||||6.7|-9.0|0.005
72594464|NCT00078949|144719934|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|-2.1||||0.55||95.0|-10.0|5.8|||Cochran-Mantel-Haenszel|||||5.8|-10.0|0.55
72594465|NCT00078949|144719935|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.77||||0.17|TWO_SIDED|95.0|0.52|1.12|||Log Rank|||It was estimated that 240 patients will be eligible for the maintenance question, and randomized with a 1:1 ratio to either rituximab or observation. It is expected that the 2-year event-free survival will be 50% on the observation arm. In order to detect a 15% difference in the 2-year event-free survival with an 80% power using a two-sided 5% level test, 142 events are required to detect an HR of 0.622.||1.12|0.52|0.17
72594466|NCT04027075|144719976|SUPERIORITY||Odds Ratio (OR)|1.02||||0.962|TWO_SIDED|95.0|0.51|2.02|||Chi-squared||The odds ratio applies to the group comparison (Intervention vs. Services as Usual) at 3-months. Group was coded 1 = Intervention and 0 = Services as Usual.|||2.02|0.51|.962
72594467|NCT04027075|144719977|SUPERIORITY||Odds Ratio (OR)|0.47||||0.109|TWO_SIDED|95.0|0.19|1.18|||Chi-squared||The odds ratio applies to the group comparison (Intervention vs. Services as Usual) at 3-months. Group was coded 1 = Intervention and 0 = Services as Usual.|||1.18|0.19|.109
72594468|NCT04027075|144719978|SUPERIORITY||Odds Ratio (OR)|1.58||||0.227|TWO_SIDED|95.0|0.75|3.29|||Chi-squared||The odds ratio applies to the group comparison (Intervention vs. Services as Usual) at 3-months. Group was coded 1 = Intervention and 0 = Services as Usual.|||3.29|0.75|.227
72594469|NCT04027075|144719979|SUPERIORITY||Odds Ratio (OR)|1.2||||0.681|TWO_SIDED|95.0|0.5|2.87|||Chi-squared||The odds ratio applies to the group comparison (Intervention vs. Services as Usual) at 3-months. Group was coded 1 = Intervention and 0 = Services as Usual.|||2.87|0.50|.681
72594470|NCT04027075|144719980|SUPERIORITY||Odds Ratio (OR)|1.18||||0.65|TWO_SIDED|95.0|0.58|2.42|||Chi-squared||The odds ratio applies to the group comparison (Intervention vs. Services as Usual) at 3-months. Group was coded 1 = Intervention and 0 = Services as Usual.|||2.42|0.58|.650
72594471|NCT04027075|144719981|SUPERIORITY||Odds Ratio (OR)|1.41||||0.304|TWO_SIDED|95.0|0.73|2.73|||Chi-squared||The odds ratio applies to the group comparison (Intervention vs. Services as Usual) at 3-months. Group was coded 1 = Intervention and 0 = Services as Usual.|||2.73|0.73|.304
72594472|NCT04027075|144719982|SUPERIORITY||Odds Ratio (OR)|1.44||||0.97|TWO_SIDED|95.0|0.69|3.0|||Chi-squared||The odds ratio applies to the group comparison (Intervention vs. Services as Usual) at 3-months. Group was coded 1 = Intervention and 0 = Services as Usual.|||3.00|0.69|0.97
72594473|NCT04027075|144719983|SUPERIORITY||Mean Difference (Final Values)|-1.78|STANDARD_ERROR_OF_MEAN|0.64||0.005|TWO_SIDED||||||t-test, 2 sided||The mean difference applies to the group comparison (Intervention vs. Services as Usual) in trajectory differences from baseline through 3-months. Group was coded 1 = Intervention and 0 = Services as Usual.|||||.005
72415003|NCT01571362|144340006|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.88|STANDARD_ERROR_OF_MEAN|4.34||0.5094|TWO_SIDED|95.0|-11.56|5.8||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|ANCOVA|||Week 8||5.80|-11.56|0.5094
72415004|NCT01571362|144340006|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.77|STANDARD_ERROR_OF_MEAN|4.043||0.4944|TWO_SIDED|95.0|-10.81|5.26||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|ANCOVA|||Week 12/ET||5.26|-10.81|0.4944
72415005|NCT01571362|144340007|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-6.76|STANDARD_ERROR_OF_MEAN|4.295||0.1201|TWO_SIDED|95.0|-15.33|1.81||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|ANCOVA|||Week 4||1.81|-15.33|0.1201
72594474|NCT04027075|144719984|SUPERIORITY||Mean Difference (Final Values)|-0.8|STANDARD_ERROR_OF_MEAN|1.09||0.46|TWO_SIDED||||||t-test, 2 sided||The mean difference applies to the group comparison (Intervention vs. Services as Usual) in trajectory differences from baseline through 3-months. Group was coded 1 = Intervention and 0 = Services as Usual.|||||.460
72594475|NCT04027075|144719985|SUPERIORITY||Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.26||0.851|TWO_SIDED||||||t-test, 2 sided||The mean difference applies to the group comparison (Intervention vs. Services as Usual) in trajectory differences from baseline through 3-months. Group was coded 1 = Intervention and 0 = Services as Usual.|||||.851
72594476|NCT04027075|144719986|SUPERIORITY||Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.23||0.977|TWO_SIDED||||||t-test, 2 sided||The mean difference applies to the group comparison (Intervention vs. Services as Usual) in trajectory differences from baseline through 3-months. Group was coded 1 = Intervention and 0 = Services as Usual.|||||.977
72594477|NCT04027075|144719987|SUPERIORITY||Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|0.27||0.456|TWO_SIDED||||||t-test, 2 sided||The mean difference applies to the group comparison (Intervention vs. Services as Usual) in trajectory differences from baseline through 3-months. Group was coded 1 = Intervention and 0 = Services as Usual.|||||.456
72594478|NCT04027075|144719988|SUPERIORITY||Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.31||0.874|TWO_SIDED||||||t-test, 2 sided||The mean difference applies to the group comparison (Intervention vs. Services as Usual) in trajectory differences from baseline through 3-months. Group was coded 1 = Intervention and 0 = Services as Usual.|||||.874
72594479|NCT04027075|144719989|SUPERIORITY||Mean Difference (Final Values)|0.44|STANDARD_ERROR_OF_MEAN|0.24||0.069|TWO_SIDED||||||t-test, 2 sided||The mean difference applies to the group comparison (Intervention vs. Services as Usual) in trajectory differences from baseline through 3-months. Group was coded 1 = Intervention and 0 = Services as Usual.|||||.069
72594480|NCT04027075|144719990|SUPERIORITY||Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.02||0.658|TWO_SIDED||||||t-test, 2 sided||The mean difference applies to the group comparison (Intervention vs. Services as Usual) in trajectory differences from baseline through 3-months. Group was coded 1 = Intervention and 0 = Services as Usual.|||||.658
72594481|NCT04027075|144719991|SUPERIORITY||Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.03||0.783|TWO_SIDED||||||t-test, 2 sided||The mean difference applies to the group comparison (Intervention vs. Services as Usual) in trajectory differences from baseline through 3-months. Group was coded 1 = Intervention and 0 = Services as Usual.|||||.783
72594482|NCT00455520|144720029|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.3|STANDARD_ERROR_OF_MEAN|0.2|<|0.001||95.0|-1.7|-0.92|||ANCOVA|||Analysis of Covariance Model with factors of treatment, country, prior opioid use, and baseline dose level and start of DB pain score as factors.||-0.92|-1.7|<0.001
72594483|NCT01541839|144720040|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|327.0|STANDARD_DEVIATION|70.0|<|0.0001|TWO_SIDED|95.0|||||t-test, 1 sided||The mean time for closure with septal stapler was 35 +/-22 seconds versus 7 minutes +/- 1 minute 10 seconds for suture closure. The mean net difference between groups was 327 seconds, or 6 minutes 27 seconds.|The operative time required for closure and NOSE questionnaire scores were analyzed with unpaired and paired t-tests respectively. Chi-squared testing was used for post-operative complication rates. The mean closure time for septoplasty was estimated to be 10 minutes +/- 4 minutes. It was assumed that the septal stapler would take 5 minutes +/- 4 minutes. Assuming a one-sided test, an alpha of 0.05 and a power of 0.8, a total of 16 patients were needed.||||<0.0001
72594484|NCT00628095|144720059|SUPERIORITY_OR_OTHER_LEGACY||Percent difference|-0.0221||||0.591|TWO_SIDED|90.0|-0.17|0.13|||Normal Approximation method|No adjustments for multiple comparisons were performed.|Power of 80% and a Type I error at 0.10 in a 1-sided test was calculated. Null hypothesis stated that there was no difference between the CE-224,535 and placebo arm groups, on the percentage of ACR 20 responders at Week 12.|Treatment effect was estimated by the difference of percentages between the treatment groups, and tested using the normal approximation method.||0.13|-0.17|0.591
72594485|NCT00628095|144720060|SUPERIORITY_OR_OTHER_LEGACY||Percent difference|-0.1232||||0.941|TWO_SIDED|80.0|-0.22|-0.02|||Normal Approximation method|||Week 2: Treatment effect was estimated by the difference of percentages between the treatment groups, and tested using the normal approximation method.||-0.02|-0.22|0.941
72594486|NCT00628095|144720060|SUPERIORITY_OR_OTHER_LEGACY||Percent difference|-0.0622||||0.742|TWO_SIDED|80.0|-0.18|0.05|||Normal Approximation method|||Week 4: Treatment effect was estimated by the difference of percentages between the treatment groups, and tested using the normal approximation method.||0.05|-0.18|0.742
72594487|NCT00628095|144720060|SUPERIORITY_OR_OTHER_LEGACY||Percent difference|0.004||||0.482|TWO_SIDED|80.0|-0.11|0.12|||Normal Approximation method|||Week 8: Treatment effect was estimated by the difference of percentages between the treatment groups, and tested using the normal approximation method.||0.12|-0.11|0.482
72594488|NCT00628095|144720061|SUPERIORITY_OR_OTHER_LEGACY||Percent difference|-0.0072||||0.989|TWO_SIDED|80.0|-0.08|0.06|||Barnard exact test|||Week 2: Treatment effect was estimated by the difference of percentages between the treatment groups, and tested using the Barnard exact test.||0.06|-0.08|0.989
72594489|NCT00628095|144720061|SUPERIORITY_OR_OTHER_LEGACY||Percent difference|-0.0096||||0.957|TWO_SIDED|80.0|-0.08|0.07|||Barnard exact test|||Week 4: Treatment effect was estimated by the difference of percentages between the treatment groups, and tested using the Barnard exact test.||0.07|-0.08|0.957
72415006|NCT01571362|144340007|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.99|STANDARD_ERROR_OF_MEAN|5.288||0.3497|TWO_SIDED|95.0|-15.6|5.62||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|ANCOVA|||Week 8||5.62|-15.60|0.3497
72594490|NCT00628095|144720061|SUPERIORITY_OR_OTHER_LEGACY||Percent difference|0.0044||||0.473|TWO_SIDED|80.0|-0.08|0.09|||Normal Approximation method|||Week 8: Treatment effect was estimated by the difference of percentages between the treatment groups, and tested using the normal approximation method.||0.09|-0.08|0.473
72594491|NCT00628095|144720061|SUPERIORITY_OR_OTHER_LEGACY||Percent difference|-0.057||||0.793|TWO_SIDED|80.0|-0.15|0.03|||Normal Approximation method|||Week 12: Treatment effect was estimated by the difference of percentages between the treatment groups, and tested using the normal approximation method.||0.03|-0.15|0.793
72594492|NCT00628095|144720062|SUPERIORITY_OR_OTHER_LEGACY||Percent difference|0.0377||||0.121|TWO_SIDED|80.0|0.0|0.09|||Barnard exact test|||Week 2: Treatment effect was estimated by the difference of percentages between the treatment groups, and tested using the Barnard exact test.||0.09|-0.00|0.121
72594493|NCT00628095|144720062|SUPERIORITY_OR_OTHER_LEGACY||Percent difference|0.0141||||0.421|TWO_SIDED|80.0|-0.05|0.07|||Barnard exact test|||Week 4: Treatment effect was estimated by the difference of percentages between the treatment groups, and tested using the Barnard exact test.||0.07|-0.05|0.421
72594494|NCT00628095|144720062|SUPERIORITY_OR_OTHER_LEGACY||Percent difference|0.0566||||0.058|TWO_SIDED|80.0|0.01|0.12|||Barnard exact test|||Week 8: Treatment effect was estimated by the difference of percentages between the treatment groups, and tested using the Barnard exact test.||0.12|0.01|0.058
72415007|NCT01571362|144340007|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.38|STANDARD_ERROR_OF_MEAN|4.532||0.6008|TWO_SIDED|95.0|-11.41|6.65||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|ANCOVA|||Week 12/ET||6.65|-11.41|0.6008
72594495|NCT00628095|144720062|SUPERIORITY_OR_OTHER_LEGACY||Percent difference|0.0377||||0.121|TWO_SIDED|80.0|0.0|0.09|||Barnard exact test|||Week 12: Treatment effect was estimated by the difference of percentages between the treatment groups, and tested using the Barnard exact test.||0.09|-0.00|0.121
72594496|NCT00628095|144720070|SUPERIORITY_OR_OTHER_LEGACY|||||||1|TWO_SIDED||||||Barnard exact test|||Week 2: p-value was analyzed using Barnard Exact Test.||||1.0000
72594497|NCT00628095|144720070|SUPERIORITY_OR_OTHER_LEGACY|||||||1|TWO_SIDED||||||Barnard exact test|||Week 4: p-value was analyzed using Barnard Exact Test.||||1.0000
72594498|NCT00628095|144720070|SUPERIORITY_OR_OTHER_LEGACY|||||||1|TWO_SIDED||||||Barnard exact test|||Week 8: p-value was analyzed using Barnard Exact Test.||||1.0000
72594499|NCT00628095|144720070|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0637|TWO_SIDED||||||Barnard exact test|||Week 12: p-value was analyzed using Barnard Exact Test.||||0.0637
72594500|NCT00628095|144720070|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0637|TWO_SIDED||||||Barnard exact test|||Week 14: p-value was analyzed using Barnard Exact Test.||||0.0637
72594501|NCT00006305|144720083|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.005||||0.97|TWO_SIDED|95.0|-0.031|0.02||A separate test with alpha=0.05 was conducted for each treatment comparison of the main effects in the 2x2 factorial design.|Log Rank||Risk difference of all-cause mortality for Revascularization compared with Medical therapy|||0.020|-0.031|0.97
72594502|NCT00006305|144720083|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.003||||0.89|TWO_SIDED|95.0|-0.029|0.022||A separate test with alpha=0.05 was conducted for each treatment comparison of the main effects in the 2x2 factorial design.|Log Rank||Risk difference of all-cause mortality for Insulin Sensitizing glycemic control strategy compared with Insulin Providing glycemic control strategy|||0.022|-0.029|0.89
72415008|NCT01571362|144340008|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-7.34|STANDARD_ERROR_OF_MEAN|4.986||0.1458|TWO_SIDED|95.0|-17.29|2.62||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|ANCOVA|||Week 4||2.62|-17.29|0.1458
72415009|NCT01571362|144340008|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-9.35|STANDARD_ERROR_OF_MEAN|6.496||0.1558|TWO_SIDED|95.0|-22.38|3.68||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|ANCOVA|||Week 8||3.68|-22.38|0.1558
72415010|NCT01571362|144340008|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.14|STANDARD_ERROR_OF_MEAN|5.582||0.3604|TWO_SIDED|95.0|-16.25|5.98||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|ANCOVA|||Week 12/ET||5.98|-16.25|0.3604
72415011|NCT01571362|144340009|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.25|STANDARD_ERROR_OF_MEAN|2.389||0.0768|TWO_SIDED|95.0|-8.95|0.46||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|ANCOVA|||Week 4||0.46|-8.95|0.0768
72594503|NCT00006305|144720084|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.013||||0.7|TWO_SIDED|95.0|-0.049|0.022||A separate test with alpha=0.05 was conducted for each treatment comparison of the main effects in the 2x2 factorial design.|Log Rank||Risk difference of Death/MI/Stroke for Revascularization compared with Medical Therapy|||0.022|-0.049|0.70
72594504|NCT00006305|144720084|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.024||||0.13||95.0|-0.06|0.012||A separate test with alpha=0.05 was conducted for each treatment comparison of the main effects in the 2x2 factorial design.|Log Rank||Risk difference of Death/MI/Stroke for Insulin Sensitizing glycemic control strategy compared with Insulin Providing glycemic control strategy|||0.012|-0.060|0.13
72594505|NCT01928797|144720085|SUPERIORITY|||||||0.37|||||||Chi-squared|||||||0.37
72594506|NCT01928797|144720086|SUPERIORITY|||||||0.33|||||||Chi-squared|||||||0.33
72594507|NCT00662558|144720088|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Differences in treatment proportions and the 95% confidence interval (CI) around the difference were estimated by calculating the risk difference between the treatment arms using a generalized linear model with treatment and center as factors. A lower 95% CI for the risk difference greater than -0.10 would demonstrate that celecoxib 200 mg BID is not inferior to tramadol hydrochloride 50 mg QID.|Risk Difference (RD)|0.091||||||95.0|0.0255|0.1565||||||||0.1565|0.0255|
72594508|NCT00662558|144720088|SUPERIORITY_OR_OTHER_LEGACY|||||||0.008||95.0|||||Cochran-Mantel-Haenszel|||If celecoxib 200 mg BID was found to be non-inferior to tramadol hydrochloride 50 mg QID then the second step was to test the superiority of celecoxib 200 mg BID over tramadol hydrochloride 50 mg QID using a two-sided test of proportions. Differences in proportions were tested using the General Association Test of the Cochran-Mantel-Haenszel (CMH) procedure stratified by center.||||0.008
72594509|NCT00662558|144720089|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.17||0.234||95.0|-0.53|0.13|||ANCOVA||The mean difference reported is the least squares (LS) mean difference.|The change from Baseline was compared between the two treatment groups using analysis of covariance (ANCOVA), with treatment and center as factors, and Baseline value as a covariate.||0.13|-0.53|0.234
72594510|NCT00662558|144720090|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.94|STANDARD_ERROR_OF_MEAN|1.76||0.595||95.0|-4.39|2.52|||ANCOVA||The mean difference reported is the LS mean difference.|The change from Baseline was compared between the two treatment groups using ANCOVA, with treatment and center as factors, and Baseline value as a covariate.||2.52|-4.39|0.595
72594511|NCT00662558|144720091|SUPERIORITY_OR_OTHER_LEGACY|||||||0.829||95.0|||||Cochran-Mantel-Haenszel|||CMH tests using row mean score and adjusted for center was used to compare the two treatment groups.||||0.829
72594512|NCT00662558|144720092|SUPERIORITY_OR_OTHER_LEGACY|||||||0.47||95.0|||||Cochran-Mantel-Haenszel|||CMH tests using row mean score and adjusted for center was used to compare the two treatment groups.||||0.470
72594513|NCT00662558|144720093|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.31|STANDARD_ERROR_OF_MEAN|0.32||0.339||95.0|-0.95|0.33|||ANCOVA||The mean difference reported is the LS mean difference.|The change from Baseline was compared between the two treatment groups using ANCOVA, with treatment and center as factors, and Baseline value as a covariate.||0.33|-0.95|0.339
72594514|NCT00662558|144720094|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.16||0.741||95.0|-0.36|0.25|||ANCOVA||The mean difference reported is the LS mean difference.|How Much Pain Now. The change from Baseline was compared between the two treatment groups using ANCOVA, with treatment and center as factors, and Baseline value as a covariate.||0.25|-0.36|0.741
72594515|NCT00662558|144720094|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.04|STANDARD_ERROR_OF_MEAN|0.17||0.796||95.0|-0.38|0.29|||ANCOVA||The mean difference reported is the LS mean difference.|Worst Pain in Past 24 Hours. The change from Baseline was compared between the two treatment groups using ANCOVA, with treatment and center as factors, and Baseline value as a covariate.||0.29|-0.38|0.796
72415012|NCT01571362|144340009|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.0|STANDARD_ERROR_OF_MEAN|2.684||0.7109|TWO_SIDED|95.0|-4.3|6.29||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|ANCOVA|||Week 8||6.29|-4.30|0.7109
72415013|NCT01571362|144340009|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.15|STANDARD_ERROR_OF_MEAN|2.536||0.1031|TWO_SIDED|95.0|-9.14|0.85||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|ANCOVA|||Week 12/ET||0.85|-9.14|0.1031
72415014|NCT01571362|144340010|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.73|STANDARD_ERROR_OF_MEAN|2.776||0.0926|TWO_SIDED|95.0|-10.26|0.8||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariates.|ANCOVA|||Week 4||0.80|-10.26|0.0926
72594516|NCT00662558|144720094|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.11|STANDARD_ERROR_OF_MEAN|0.16||0.492||95.0|-0.41|0.2|||ANCOVA||The mean difference reported is the LS mean difference.|Average Pain in Past 24 Hours. The change from Baseline was compared between the two treatment groups using ANCOVA, with treatment and center as factors, and Baseline value as a covariate.||0.20|-0.41|0.492
72594517|NCT00662558|144720094|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.16||0.893||95.0|-0.28|0.33|||ANCOVA||The mean difference reported is the LS mean difference.|Pain Interfered With General Activity. The change from Baseline was compared between the two treatment groups using ANCOVA, with treatment and center as factors, and Baseline value as a covariate.||0.33|-0.28|0.893
72594518|NCT00662558|144720094|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.08|STANDARD_ERROR_OF_MEAN|0.16||0.618||95.0|-0.4|0.24|||ANCOVA||The mean difference reported is the LS mean difference.|Pain Interfered With Mood. The change from Baseline was compared between the two treatment groups using ANCOVA, with treatment and center as factors, and Baseline value as a covariate.||0.24|-0.40|0.618
72594519|NCT00662558|144720094|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.12|STANDARD_ERROR_OF_MEAN|0.16||0.44||95.0|-0.19|0.43|||ANCOVA||The mean difference reported is the LS mean difference.|Pain Interfered With Walking Activity. The change from Baseline was compared between the two treatment groups using ANCOVA, with treatment and center as factors, and Baseline value as a covariate.||0.43|-0.19|0.440
72594520|NCT00662558|144720094|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.04|STANDARD_ERROR_OF_MEAN|0.14||0.806||95.0|-0.25|0.32|||ANCOVA||The mean difference reported is the LS mean difference.|Pain Interfered With Relations With Others. The change from Baseline was compared between the two treatment groups using ANCOVA, with treatment and center as factors, and Baseline value as a covariate.||0.32|-0.25|0.806
72594521|NCT00662558|144720094|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.17||0.739||95.0|-0.38|0.27|||ANCOVA||The mean difference reported is the LS mean difference.|Pain Interfered With Sleep. The change from Baseline was compared between the two treatment groups using ANCOVA, with treatment and center as factors, and Baseline value as a covariate.||0.27|-0.38|0.739
72594522|NCT00662558|144720094|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.17||0.992||95.0|-0.32|0.33|||ANCOVA||The mean difference reported is the LS mean difference.|Pain Interfered With Normal Work. The change from Baseline was compared between the two treatment groups using ANCOVA, with treatment and center as factors, and Baseline value as a covariate.||0.33|-0.32|0.992
72594523|NCT00662558|144720094|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.04|STANDARD_ERROR_OF_MEAN|0.16||0.793||95.0|-0.28|0.36|||ANCOVA||The mean difference reported is the LS mean difference.|Pain Interfered With Enjoyment of Life. The change from Baseline was compared between the two treatment groups using ANCOVA, with treatment and center as factors, and Baseline value as a covariate.||0.36|-0.28|0.793
72594524|NCT00662558|144720094|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.14||0.973||95.0|-0.27|0.28|||ANCOVA||The mean difference reported is the LS mean difference.|Pain Interference Subscale. The change from Baseline was compared between the two treatment groups using ANCOVA, with treatment and center as factors, and Baseline value as a covariate.||0.28|-0.27|0.973
72594525|NCT00662558|144720095|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.29|STANDARD_ERROR_OF_MEAN|1.51||0.392||95.0|-4.26|1.67|||ANCOVA||The mean difference reported is the LS mean difference.|Sleep Disturbance. The change from Baseline was compared between the two treatment groups using ANCOVA, with treatment and center as factors, and Baseline value as a covariate.||1.67|-4.26|0.392
72594526|NCT00662558|144720095|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.66|STANDARD_ERROR_OF_MEAN|1.67||0.691||95.0|-3.94|2.61|||ANCOVA||The mean difference reported is the LS mean difference.|Snoring. The change from Baseline was compared between the two treatment groups using ANCOVA, with treatment and center as factors, and Baseline value as a covariate.||2.61|-3.94|0.691
72594527|NCT00662558|144720095|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.87|STANDARD_ERROR_OF_MEAN|1.45||0.549||95.0|-3.7|1.97|||ANCOVA||The mean difference reported is the LS mean difference.|Awaken Shortness of Breath or Headache. The change from Baseline was compared between the two treatment groups using ANCOVA, with treatment and center as factors, and Baseline value as a covariate.||1.97|-3.70|0.549
72594528|NCT00662558|144720095|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.22|STANDARD_ERROR_OF_MEAN|0.23||0.336||95.0|-0.67|0.23|||ANCOVA||The mean difference reported is the LS mean difference.|Quantity of Sleep. The change from Baseline was compared between the two treatment groups using ANCOVA, with treatment and center as factors, and Baseline value as a covariate.||0.23|-0.67|0.336
72594529|NCT00662558|144720095|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.51|STANDARD_ERROR_OF_MEAN|1.69||0.37||95.0|-4.83|1.8|||ANCOVA||The mean difference reported is the LS mean difference.|Sleep Adequacy. The change from Baseline was compared between the two treatment groups using ANCOVA, with treatment and center as factors, and Baseline value as a covariate.||1.80|-4.83|0.370
72594530|NCT00662558|144720095|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.27|STANDARD_ERROR_OF_MEAN|1.34||0.341||95.0|-3.9|1.35|||ANCOVA||The mean difference reported is the LS mean difference.|Somnolence. The change from Baseline was compared between the two treatment groups using ANCOVA, with treatment and center as factors, and Baseline value as a covariate.||1.35|-3.90|0.341
72594531|NCT00662558|144720095|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.59|STANDARD_ERROR_OF_MEAN|1.15||0.604||95.0|-2.85|1.66|||ANCOVA||The mean difference reported is the LS mean difference.|Sleep Problem Index I. The change from Baseline was compared between the two treatment groups using ANCOVA, with treatment and center as factors, and Baseline value as a covariate.||1.66|-2.85|0.604
72594532|NCT00662558|144720095|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.68|STANDARD_ERROR_OF_MEAN|1.14||0.547||95.0|-2.92|1.55|||ANCOVA||The mean difference reported is the LS mean difference.|Sleep Problem Index II. The change from Baseline was compared between the two treatment groups using ANCOVA, with treatment and center as factors, and Baseline value as a covariate.||1.55|-2.92|0.547
72594533|NCT00662558|144720096|SUPERIORITY_OR_OTHER_LEGACY|||||||0.196||95.0|||||Cochran-Mantel-Haenszel|||Optimal sleep was analyzed using CMH general association test.||||0.196
72415015|NCT01571362|144340010|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.59|STANDARD_ERROR_OF_MEAN|3.414||0.6437|TWO_SIDED|95.0|-8.42|5.24||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariates.|ANCOVA|||Week 8||5.24|-8.42|0.6437
72594534|NCT00662558|144720097|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.19|STANDARD_ERROR_OF_MEAN|1.91||0.252||95.0|-1.56|5.94|||ANCOVA||The mean difference reported is the LS mean difference.|Time Scale. The change from Baseline was compared between the two treatment groups using ANCOVA, with treatment and center as factors, and Baseline value as a covariate.||5.94|-1.56|0.252
72594535|NCT00662558|144720097|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.48|STANDARD_ERROR_OF_MEAN|1.88||0.798||95.0|-3.21|4.17|||ANCOVA||The mean difference reported is the LS mean difference.|Physical Scale. The change from Baseline was compared between the two treatment groups using ANCOVA, with treatment and center as factors, and Baseline value as a covariate.||4.17|-3.21|0.798
72594536|NCT00662558|144720097|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.74|STANDARD_ERROR_OF_MEAN|1.92||0.7||95.0|-3.03|4.51|||ANCOVA||The mean difference reported is the LS mean difference.|Output Scale. The change from Baseline was compared between the two treatment groups using ANCOVA, with treatment and center as factors, and Baseline value as a covariate.||4.51|-3.03|0.700
72594537|NCT00662558|144720097|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.21|STANDARD_ERROR_OF_MEAN|1.72||0.902||95.0|-3.16|3.59|||ANCOVA||The mean difference reported is the LS mean difference.|Mental-Interpersonal Scale. The change from Baseline was compared between the two treatment groups using ANCOVA, with treatment and center as factors, and Baseline value as a covariate.||3.59|-3.16|0.902
72594538|NCT00662558|144720097|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.25|STANDARD_ERROR_OF_MEAN|0.46||0.581||95.0|-0.65|1.16|||ANCOVA||The mean difference reported is the LS mean difference.|Index Scale. The change from Baseline was compared between the two treatment groups using ANCOVA, with treatment and center as factors, and Baseline value as a covariate.||1.16|-0.65|0.581
72594539|NCT00662558|144720098|SUPERIORITY_OR_OTHER_LEGACY|||||||0.614||95.0|||||Cochran-Mantel-Haenszel|||P-value reported is the overall p-value for Week 1.||||0.614
72594540|NCT00662558|144720098|SUPERIORITY_OR_OTHER_LEGACY|||||||0.786||95.0|||||Cochran-Mantel-Haenszel|||P-value reported is the overall p-value for Week 3.||||0.786
72594541|NCT00662558|144720098|SUPERIORITY_OR_OTHER_LEGACY|||||||0.044||95.0|||||Cochran-Mantel-Haenszel|||P-value reported is the overall p-value for Week 6/ET.||||0.044
72594542|NCT00662558|144720099|SUPERIORITY_OR_OTHER_LEGACY|||||||0.87||95.0|||||Cochran-Mantel-Haenszel|||CMH tests using row mean score and adjusted for center was used to compare the two treatment groups.||||0.870
72594543|NCT00662558|144720100|SUPERIORITY_OR_OTHER_LEGACY|||||||0.545||95.0|||||Cochran-Mantel-Haenszel|||CMH tests using row mean score and adjusted for center was used to compare the two treatment groups.||||0.545
72594544|NCT00662558|144720101|SUPERIORITY_OR_OTHER_LEGACY|||||||0.218||95.0|||||Cochran-Mantel-Haenszel|||CMH test adjusted for center was used to compare the two treatment groups.||||0.218
72594545|NCT00783224|144720106|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0001||95.0|||||ANCOVA|||||||0.0001
72594546|NCT00783224|144720106|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0001||95.0|||||ANCOVA|||||||0.0001
72594547|NCT01711619|144720107|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Nominal alpha of 4% was predefined for the final analysis.|Fisher Exact|||Subjects with missing information were considered in the test and computation of the proportion for ITT.||||<0.0001
72594548|NCT01711619|144720108|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Nominal alpha of 5% was pre-defined for the final analysis.|Regression, Linear|||||||<0.0001
72594549|NCT01711619|144720109|SUPERIORITY_OR_OTHER|||||||0.0002||||||Nominal alpha of 5% was pre-defined for the final analysis.|Fisher Exact|||Subjects with missing information were considered in the test and computation for ITT.||||0.0002
72594550|NCT01711619|144720110|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Nominal alpha of 5% was pre-defined for the final analysis.|Fisher Exact|||Subjects with missing information were considered in the test and computation for ITT.||||<0.0001
72594551|NCT02635542|144720111|SUPERIORITY|||||||1|||||||Chi-squared|||||||1.00
72594552|NCT02635542|144720112|SUPERIORITY|||||||0.02|||||||t-test, 2 sided|||||||0.02
72594553|NCT00475878|144720167|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.64|STANDARD_ERROR_OF_MEAN|0.22||0.19|TWO_SIDED|95.0|0.33|1.24|||Chi-squared|||||1.24|.33|.19
72594554|NCT00475878|144720168|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.96|STANDARD_ERROR_OF_MEAN|2.16||0.18|TWO_SIDED|95.0|-2.79|5.84|||t-test, 2 sided|||||5.84|-2.79|.18
72594555|NCT00231283|144720169|SUPERIORITY_OR_OTHER||Percentage of participants|97.0|STANDARD_ERROR_OF_MEAN|1.71||||95.0|91.5|99.4|||Qualitative Comparison|Reported in qualitative/semi-quantitative comparitive fashion due to study design.||||99.4|91.5|
72594556|NCT00231283|144720170|SUPERIORITY_OR_OTHER||Percentage of participants|3.0||||||95.0|0.6|8.6|||No formal statistical testing|||||8.6|0.6|
72594557|NCT00231283|144720171|SUPERIORITY_OR_OTHER||Percentage of participants|3.0||||||95.0|0.6|8.5|||Descriptive statistics|||||8.5|0.6|
72594558|NCT00231283|144720172|SUPERIORITY_OR_OTHER||Percentage of participants|10.4||||||95.0|5.1|18.3|||Descriptive statistics|||||18.3|5.1|
72594559|NCT01225289|144720173|SUPERIORITY_OR_OTHER||||||<|0.01||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.01
72594560|NCT01606202|144720195|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-0.08||||0.708|TWO_SIDED|95.0|-0.51|0.35|||ANCOVA|||The change in the pain Numerical Rating Scale score from baseline to End of Treatment was compared between treatment groups using analysis of covariance (ANCOVA). The model included treatment and centre as factors and baseline Numerical Rating Scale pain mean score as a covariate.||0.35|-0.51|0.708
72415016|NCT01571362|144340010|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.09|STANDARD_ERROR_OF_MEAN|3.391||0.748|TWO_SIDED|95.0|-7.84|5.65||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariates.|ANCOVA|||Week 12/ET||5.65|-7.84|0.7480
72594561|NCT01606202|144720196|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-0.57||||0.852|TWO_SIDED|95.0|-6.62|5.48|||ANCOVA|||The change from baseline to End of Treatment in the percentage of days on which escape medication was used was compared between treatment groups using ANCOVA. The model included treatment and centre as factors and percentage of days on which escape medication was used as a covariate.||5.48|-6.62|0.852
72594562|NCT01606202|144720197|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|0.05||||0.86|TWO_SIDED|95.0|-0.54|0.65|||ANCOVA|||The change from baseline to End of Treatment in the Spasm severity Numerical Rating Scale score was compared between treatment groups using ANCOVA. The model included treatment and centre as factors and the Spasm severity Numerical Rating Scale score as a covariate.||0.65|-0.54|0.860
72594563|NCT01606202|144720198|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-0.64||||0.873|TWO_SIDED|95.0|-8.56|7.27|||ANCOVA|||The change from baseline to End of Treatment in the percentage of days on which spasm was experienced was compared between treatment groups using ANCOVA. The model included treatment and centre as factors and the Spasm percentage of days on which spasm was experienced as a covariate.||7.27|-8.56|0.873
72594564|NCT01606202|144720199|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|0.07||||0.83|TWO_SIDED|95.0|-0.61|0.75|||ANCOVA|||The change from baseline to End of Treatment in the spasticity severity Numerical Rating Scale score was compared between treatment groups using ANCOVA. The model included treatment and centre as factors and the baseline spasticity severity Numerical Rating Scale score as a covariate.||0.75|-0.61|0.830
72594565|NCT01606202|144720200|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|0.4||||0.86|TWO_SIDED|95.0|-4.08|4.88|||ANCOVA|||The change from baseline to End of Treatment in the percentage of days on which spasticity was experienced was compared between treatment groups using ANCOVA. The model included treatment and centre as factors and the percentage of days on which spasticity was experienced as a covariate.||4.88|-4.08|0.860
72594566|NCT01606202|144720201|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-0.14||||0.142|TWO_SIDED|95.0|-0.33|0.05|||ANCOVA|||The change from baseline to End of Treatment in the Modified Ashworth scale score was compared between treatment groups using ANCOVA. The model included treatment and centre as factors and the Modified Ashworth scale score as a covariate.||0.05|-0.33|0.142
72594567|NCT01606202|144720202|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-0.11||||0.824|TWO_SIDED|95.0|-1.13|0.9|||ANCOVA|||The change from baseline in the mean Short Orientation Memory Concentration score, was compared between treatment groups using ANCOVA. The model included treatment and centre as factors and baseline Short Orientation Memory Concentration test score as a covariate.||0.90|-1.13|0.824
72594568|NCT01606202|144720203|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-0.04||||0.847|TWO_SIDED|95.0|-0.49|0.4|||ANCOVA|||The change from baseline to End of Treatment in the Spitzer Quality of Life Index score was compared between treatment groups using ANCOVA. The model included treatment and centre as factors and the Spitzer Quality of Life Index score as a covariate.||0.40|-0.49|0.847
72594569|NCT01606202|144720204|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-1.29||||0.287|TWO_SIDED|95.0|-3.74|1.16|||ANCOVA|||The change from baseline to End of Treatment in the Caregiver Strain Index score was compared between treatment groups using ANCOVA. The model included treatment and centre as factors and the baseline Caregiver Strain Index score as a covariate.||1.16|-3.74|0.287
72594570|NCT01606202|144720205|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|33.86|||<|0.001|TWO_SIDED|95.0|17.07|50.64|||Fisher Exact|||The proportion of subjects who considered their condition 'Very Much Improved', 'Much Improved' or 'Minimally Improved' was compared between treatment groups using Fisher's Exact Test.||50.64|17.07|<0.001
72594571|NCT01606202|144720206|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-1.93||||0.032|TWO_SIDED|95.0|-3.69|-0.16|||ANCOVA|||The change from baseline to End of Treatment in the Brief Pain Inventory score was compared between treatment groups using ANCOVA. The model included treatment and centre as factors and baseline Brief Pain Inventory score as a covariate.||-0.16|-3.69|0.032
72594572|NCT02584959|144720209|OTHER||Difference in LS means|-2.32|||<|0.0001|TWO_SIDED|95.0|-2.895|-1.744|||Mixed Models Analysis|||The LS means, 95% CIs, and p-values were based on a mixed effect linear model with period, sequence ,use of prophylactic therapy with C1 INH at randomization, and treatment as fixed effects and subject nested within sequence as a random effect.||-1.744|-2.895|<0.0001
72594573|NCT02584959|144720211|OTHER||Difference in LS means|-2.323|||<|0.0001|TWO_SIDED|95.0|-2.969|-1.677|||Mixed Models Analysis|||The LS means, 95% CIs, and p-values were based on a mixed effect linear model with period, sequence ,use of prophylactic therapy with C1 INH at randomization, and treatment as fixed effects and subject nested within sequence as a random effect.||-1.677|-2.969|<0.0001
72594574|NCT02584959|144720214|OTHER||Difference in LS means|-4.881|||<|0.0001|TWO_SIDED|95.0|-6.113|-3.649|||Mixed Models Analysis|||The LS means, 95% CIs, and p-values were based on a mixed effect linear model with period, sequence ,use of prophylactic therapy with C1 INH at randomization, and treatment as fixed effects and subject nested within sequence as a random effect.||-3.649|-6.113|<0.0001
72594575|NCT02584959|144720215|OTHER||Difference in LS means|5.435|||<|0.0001|TWO_SIDED|95.0|3.981|6.889|||Mixed Models Analysis|||||6.889|3.981|<0.0001
72594576|NCT02584959|144720216|OTHER||Difference in LS means|-2.175|||<|0.0001|TWO_SIDED|95.0|-2.75|-1.599|||Mixed Models Analysis|||||-1.599|-2.750|<0.0001
72415017|NCT01571362|144340011|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-12.38|STANDARD_ERROR_OF_MEAN|4.666||0.0098|TWO_SIDED|95.0|-21.68|-3.07||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariates.|ANCOVA|||Week 4||-3.07|-21.68|0.0098
72415018|NCT01571362|144340011|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-12.94|STANDARD_ERROR_OF_MEAN|5.336||0.0186|TWO_SIDED|95.0|-23.63|-2.25||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariates.|ANCOVA|||Week 8||-2.25|-23.63|0.0186
72415019|NCT01571362|144340011|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-9.2|STANDARD_ERROR_OF_MEAN|4.785||0.0581|TWO_SIDED|95.0|-18.72|0.32||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariates.|ANCOVA|||Week 12/ET||0.32|-18.72|0.0581
72594577|NCT02584959|144720231|OTHER||Difference in LS means|-31.735||||0.0001|TWO_SIDED|95.0|-42.696|-20.773|||Mixed Models Analysis|||The Least Square means, 95% confidence intervals and p-values are based on mixed effect linear model with period, sequence, use of prophylactic therapy with C1 INH at randomization and treatment as fixed effects and subject nested within sequence as a random effect.||-20.773|-42.696|0.0001
72594578|NCT00195494|144720243|SUPERIORITY_OR_OTHER||Risk Difference (RD)|22.0|||<|0.001|||||||Fisher Exact||E+M (49.8%) - M (27.8%) creates the risk difference estimated value.|||||<0.001
72594579|NCT00195494|144720244|SUPERIORITY_OR_OTHER||Risk Difference (RD)|21.0|||<|0.001|||||||Fisher Exact||E+M (79.7%) - M (58.7%) creates the risk difference estimated value.|||||<0.001
72594580|NCT03019003|144720247|OTHER||||||<|0.036|||||||t-test, 2 sided|||||||<0.036
72594581|NCT03309696|144720292|EQUIVALENCE|A p value of \<.0.05 is taken as evidence of nonequivalence.|Mean Difference (Net)|-0.59||||0.055|TWO_SIDED|||||The p value is not adjusted because it was a planned contrast.|Mixed Models Analysis||Active tDCS - sham tDCS.|Examines the effect of tDCS preconditioning on P100 amplitudes. The effect size for this comparison was .33 (Cohen's).||||.055
72594582|NCT03309696|144720292|EQUIVALENCE|A p value of \<.05 is taken as evidence of nonequivalence.|Mean Difference (Net)|0.36||||0.0418|TWO_SIDED|||||This p value is not adjusted for multiple comparisons because it was a planned contrast.|Mixed Models Analysis||Sham tDCS - Sham tDCS and Active rTMS|Examines the effect of rTMS on the P100 amplitude. The calculated effect size is .35 (Cohen's).||||0.0418
72594583|NCT03309696|144720292|EQUIVALENCE|A p value less than 0.05 is taken as evidence of nonequivalence.|Mean Difference (Net)|-0.19||||0.4|TWO_SIDED|||||The p value is not adjusted as this was a planned contrast.|Mixed Models Analysis||Effect of tDCS preconditioning on active rTMS: active tDCS preconditioning of active rTMS - sham tDCS preconditioning of active rTMS.|Examines the additive effect of tDCS preconditioning on the P100 amplitude after rTMS. The effect size for this comparison was 0.14.||||0.40
72594584|NCT03309696|144720292|EQUIVALENCE|A p value less than 0.05 is taken as evidence of nonequivalence.|Mean Difference (Net)|-0.48||||0.086|TWO_SIDED|||||The p value was not adjusted for this planned contrast.|Mixed Models Analysis||Active tDCS and Active rTMS - Sham tDCS and Sham rTMS.|Examines the combined effect of tDCS and rTMS on the P100 amplitude. The effect size for this comparison was .29 (Cohen's).||||.086
72594585|NCT02102100|144720300|OTHER||Mean Difference (Net)|0.9436|||<|0.0001|TWO_SIDED||||||Mixed Models Analysis|||Least square means and standard errors were calculated to describe the patterns of means for each outcome. Effect slices were tested to explain significant interactions in the models. Pairwise comparisons of least square means were used to describe significant main effects.||||<.0001
72415020|NCT01571362|144340012|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-12.56|STANDARD_ERROR_OF_MEAN|5.168||0.0177|TWO_SIDED|95.0|-22.87|-2.25||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariates.|ANCOVA|||Week 4||-2.25|-22.87|0.0177
72594586|NCT00328094|144720301|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.29||||0.23|TWO_SIDED|95.0|0.85|1.97|||Chi-squared|||||1.97|0.85|0.23
72594587|NCT00355706|144720322|SUPERIORITY_OR_OTHER_LEGACY|||||||0.964||95.0|||||ANOVA|||||||0.964
72594588|NCT00355706|144720323|SUPERIORITY_OR_OTHER_LEGACY|||||||0.892||95.0|||||ANOVA|||||||0.892
72594589|NCT00355706|144720324|SUPERIORITY_OR_OTHER_LEGACY|||||||0.56||95.0|||||ANOVA|||||||0.560
72594590|NCT01313494|144720325|SUPERIORITY_OR_OTHER||LSM Difference|0.071|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|0.046|0.095|||Repeated measures ANCOVA|Independent variables: treatment, baseline value of pre-bronchodilator FEV1, time and a treatment-by-time interaction.||The primary endpoint was tested in a confirmatory manner with a 2-sided significance level of 5%.||0.095|0.046|<0.0001
72415021|NCT01571362|144340012|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-14.16|STANDARD_ERROR_OF_MEAN|5.998||0.0219|TWO_SIDED|95.0|-26.19|-2.14||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariates.|ANCOVA|||Week 8||-2.14|-26.19|0.0219
72594591|NCT00956631|144720349|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.2|||<|0.0001|TWO_SIDED|95.0|2.29|4.13|||t-test, 2 sided|||The mean change from baseline was assessed for VAS using a paired t-test. The resulting p-values are to be considered as descriptive statistics. Two-sided test with 5% Type I error was used throughout. A hypothetical average improvement of zero was used.||4.13|2.29|<0.0001
72594592|NCT00956631|144720350|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|17.58|||<|0.0001|TWO_SIDED|95.0|12.33|22.83|||t-test, 2 sided|||The mean change from baseline was assessed for ODI using a paired t-test. The resulting p-values are to be considered as descriptive statistics. Two-sided test with 5% Type I error was used. A hypothetical average improvement of zero was used.||22.83|12.33|<0.0001
72415022|NCT01571362|144340012|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-10.35|STANDARD_ERROR_OF_MEAN|5.589||0.0679|TWO_SIDED|95.0|-21.47|0.78||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariates.|ANCOVA|||Week 12/ET||0.78|-21.47|0.0679
72415023|NCT01571362|144340013|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-7.5|STANDARD_ERROR_OF_MEAN|2.654||0.0052|TWO_SIDED|95.0|-12.72|-2.27||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariates.|ANCOVA|||Week 4||-2.27|-12.72|0.0052
72415024|NCT01571362|144340013|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.62|STANDARD_ERROR_OF_MEAN|2.999||0.1249|TWO_SIDED|95.0|-10.54|1.29||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariates.|ANCOVA|||Week 8||1.29|-10.54|0.1249
72415025|NCT01571362|144340013|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-8.19|STANDARD_ERROR_OF_MEAN|2.818||0.004|TWO_SIDED|95.0|-13.74|-2.64||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariates.|ANCOVA|||Week 12/ET||-2.64|-13.74|0.0040
72415026|NCT01221597|144340048|SUPERIORITY_OR_OTHER|||||||0.0005|TWO_SIDED||||||ANOVA|||||||0.0005
72415027|NCT01221597|144340049|SUPERIORITY_OR_OTHER|||||||0.0451|TWO_SIDED||||||ANOVA|||||||0.0451
72415028|NCT01221597|144340050|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<.0001
72415029|NCT01221597|144340051|SUPERIORITY_OR_OTHER|||||||0.0268|TWO_SIDED||||||ANOVA|||||||0.0268
72594593|NCT03422159|144720352|NON_INFERIORITY|Based on the results of the preliminary study of Marik et al, 5 we projected that the combination of ascorbic acid, thiamine, and hydrocortisone could reduce time to vasopressor discontinuation from 54 (+/-30 hours) vs 30 hours. For the additional primary outcome, we projected a greater change of SOFA score of 4 (+/-3) vs 2. Assuming a type 1 error of 5% (alpha of 0.05) and a power of 80%, this study would require a sample size of 94 patients.|||||<|0.001|||||||t-test, 2 sided|||||||<0.001
72415030|NCT01221597|144340052|SUPERIORITY_OR_OTHER|||||||0.08|TWO_SIDED||||||ANOVA|||||||0.0800
72415031|NCT01221597|144340053|SUPERIORITY_OR_OTHER|||||||0.3085|TWO_SIDED||||||ANOVA|||||||0.3085
72594594|NCT01153620|144720382|SUPERIORITY_OR_OTHER||||||=|0.006||95.0|||||Wilcoxon (Mann-Whitney)|||||||=0.006
72594595|NCT01832818|144720397|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<0.05
72594596|NCT01832818|144720398|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||< 0.05
72594597|NCT01256385|144720434|SUPERIORITY_OR_OTHER|||||||0.73|||||||Log Rank|||||||0.73
72594598|NCT01256385|144720435|SUPERIORITY_OR_OTHER|||||||0.87|||||||Log Rank|||||||0.87
72594599|NCT01256385|144720436|SUPERIORITY_OR_OTHER|||||||0.2|||||||Fisher Exact|||||||0.20
72594600|NCT01256385|144720437|SUPERIORITY|||||||0.006|||||||Chi-squared|||PFS at 4 months in Arm A was compared with a 4-month historical control rate of 21.4%, using a one-sided test at the 0.05 significant level. The historical data appear in two publications, an ASCO abstract: Abidoye, ASCO Annual Meeting 2006: 5568, and de Souza, Davis, et al, Clin Cancer Res 2012; 18(8):2336-2343 (see Figure 1).||||0.006
72594601|NCT01256385|144720437|SUPERIORITY|||||||0.037||||||1-sided.|Chi-squared|||PFS at 4 months in Arm B was compared with a 4-month historical control rate of 21.4%, using a one-sided test at the 0.05 significant level. The historical data appear in two publications, an ASCO abstract: Abidoye, ASCO Annual Meeting 2006: 5568, and de Souza, Davis, et al, Clin Cancer Res 2012; 18(8):2336-2343 (see Figure 1).||||0.037
72594602|NCT01256385|144720438|SUPERIORITY_OR_OTHER|||||||0.59|||||||Fisher Exact|||||||0.59
72594603|NCT00725101|144720532|SUPERIORITY_OR_OTHER|||||||0.0074||95.0||||P-value for age over 65.|Regression, Logistic|||||||0.0074
72594604|NCT00725101|144720532|SUPERIORITY_OR_OTHER|||||||0.0028||95.0||||P-value for female physicians.|Regression, Logistic|||||||0.0028
72594605|NCT00725101|144720532|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||P-value for Rheumatology versus PCP.|Regression, Logistic|||||||<0.0001
72594606|NCT00725101|144720532|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||P-value for other specialty versus PCP.|Regression, Logistic|||||||<0.0001
72594607|NCT00725101|144720532|SUPERIORITY_OR_OTHER|||||||0.0064||95.0||||P-value for use of opioids.|Regression, Logistic|||||||0.0064
72594608|NCT00725101|144720532|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||P-value for use of NSAIDs.|Regression, Logistic|||||||<0.0001
72594609|NCT00725101|144720532|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||P-value for number of medications participants were taking.|Regression, Logistic|||||||<0.0001
72594610|NCT00725101|144720533|SUPERIORITY_OR_OTHER|||||||0.026||95.0||||P-value for GAD-7 score.|Regression, Logistic|||||||0.026
72415032|NCT01221597|144340054|SUPERIORITY_OR_OTHER|||||||0.6321|TWO_SIDED||||||ANOVA|||||||0.6321
72594611|NCT00725101|144720533|SUPERIORITY_OR_OTHER|||||||0.021||95.0||||P-value for pregabalin use.|Regression, Logistic|||||||0.021
72594612|NCT00725101|144720533|SUPERIORITY_OR_OTHER|||||||0.05||95.0||||P-value for NSAID use.|Regression, Logistic|||||||0.050
72594613|NCT02889835|144720585|SUPERIORITY|||||||0.686|||||||Log Rank|||Kaplan-Meier analysis was performed to assess survival over 36 months. Test of survival distributions for the three arms were calculated using Log Rank (Mantel-Cox). Sample size is based on guidelines of the American Dental Association for obtaining approval as an amalgam replacement for posterior restorations - minimum of 40 restorations in a minimum of 20 subjects at 18 months. Sample size is based by taking subject attrition into account over the 36 month clinical evaluation.||||0.686
72594614|NCT02889835|144720586|SUPERIORITY|||||||0.701|||||||Kruskal-Wallis|||||||0.701
72594615|NCT02889835|144720587|SUPERIORITY|||||||0.812|||||||Kruskal-Wallis|||||||0.812
72594616|NCT02889835|144720588|SUPERIORITY|||||||0.104|||||||Kruskal-Wallis|||||||0.104
72594617|NCT02889835|144720589|SUPERIORITY|||||||0.44|||||||Kruskal-Wallis|||||||0.440
72594618|NCT02889835|144720590|SUPERIORITY|||||||0.676|||||||Kruskal-Wallis|||||||0.676
72594619|NCT02889835|144720591|SUPERIORITY|||||||1|||||||Kruskal-Wallis|||||||1.000
72594620|NCT02889835|144720592|SUPERIORITY|||||||0.764|||||||Kruskal-Wallis|||||||0.764
72594621|NCT02889835|144720593|SUPERIORITY|||||||0.323|||||||Kruskal-Wallis|||||||0.323
72594622|NCT02889835|144720594|SUPERIORITY|||||||0.714|||||||Kruskal-Wallis|||||||0.714
72594623|NCT02889835|144720595|SUPERIORITY|||||||0.846|||||||Kruskal-Wallis|||||||0.846
72594624|NCT02889835|144720596|SUPERIORITY|||||||1|||||||Kruskal-Wallis|||||||1.000
72594625|NCT02889835|144720597|SUPERIORITY|||||||0.424|||||||Kruskal-Wallis|||||||0.424
72594626|NCT02502266|144720645|SUPERIORITY||Hazard Ratio (HR)|0.649|||||TWO_SIDED|95.0|0.424|0.995|||||The hazard ratio estimate compares Cediranib and Olaparib to chemotherapy. If Cediranib and Olaparib is superior, the hazard ratio is \<1.0.|Experimental regimens with at least a 17% reduction in the estimated PFS event rate (compared to standard chemotherapy) (HR estimate \< 0.83) were recommended for further evaluation in the phase III trial.||0.995|0.424|
72415033|NCT01221597|144340055|SUPERIORITY_OR_OTHER|||||||0.7965|TWO_SIDED||||||ANOVA|||||||0.7965
72415034|NCT01221597|144340056|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.0001
72594627|NCT02502266|144720645|SUPERIORITY||Hazard Ratio (HR)|0.832|||||TWO_SIDED|95.0|0.539|1.284|||||The hazard ratio estimate compares Cediranib to chemotherapy. If Cediranib is superior, the hazard ratio is \<1.0.|Experimental regimens with at least a 17% reduction in the estimated PFS event rate (compared to standard chemotherapy) (HR estimate \< 0.83) were recommended for further evaluation in the phase III trial.||1.284|0.539|
72594628|NCT02502266|144720645|SUPERIORITY||Hazard Ratio (HR)|1.149|||||TWO_SIDED|95.0|0.745|1.773|||||The hazard ratio estimate compares Olaparib to chemotherapy. If Olaparib is superior, the hazard ratio is \<1.0.|Experimental regimens with at least a 17% reduction in the estimated PFS event rate (compared to standard chemotherapy) (HR estimate \< 0.83) were recommended for further evaluation in the phase III trial.||1.773|0.745|
72415035|NCT03667053|144340060|SUPERIORITY||||||<|0.001|||||||Log Rank|||The treatment group difference between dasiglucagon and placebo was evaluated inferentially using a pairwise two-sided log rank test stratified by injection site and age group.||||<0.001
72415036|NCT03667053|144340061|SUPERIORITY|||||||0.0073||||||Assessed at 30 minutes. Note that p-value was 0.0005 at 10 minutes and \<0.0001 at 15 and 20 minutes.|Cochran-Mantel-Haenszel|||The recovery rates of dasiglucagon and placebo were compared at each time point using a Cochran-Mantel-Haenszel test stratified by age group and injection site. Testing followed an a priori defined hierarchical inferential test order, proceeding until the first failure to reject the null hypothesis comparing dasiglucagon versus placebo.||||0.0073
72415037|NCT03667053|144340062|SUPERIORITY||||||<|0.0001||||||The p-value was \<0.0001 at all time points (10, 15, 20 and 30 minutes)|ANOVA|||Change from baseline in plasma glucose at 30, 20, 15, and 10 minutes after investigational product injection was calculated using nominal sampling times and analyzed using an analysis of variance model with treatment, age group and injection site for each endpoint. Testing followed an a priori defined hierarchical inferential test order, proceeding until the first failure to reject the null hypothesis comparing dasiglucagon versus placebo.||||<0.0001
72415038|NCT02071173|144340086|SUPERIORITY|Single group test comparison to a performance goal of 87%. Lower one-sided 97.5% confidence limit was compared to the performance goal. If lower confidence limit exceeded performance goal, null hypothesis was rejected.|Percent|98.5|||||ONE_SIDED|97.5|97.0|||||||Ho: The Implant through 6-month lead-related complication-free rate ≤ 87%, Ha: The Implant through 6-month lead-related complication-free rate \> 87%|||97.0|
72415039|NCT02071173|144340087|SUPERIORITY|Single group test comparison to a performance goal of 85%. Lower one-sided 95% confidence limit was compared to the performance goal. If lower confidence limit exceeded performance goal, null hypothesis was rejected.|Percent|96.5|||||ONE_SIDED|95.0|93.8|||||||Ho: The Implant through 6-month lead-related complication-free rate ≤ 85%, Ha: The Implant through 6-month lead-related complication-free rate \> 85%|||93.8|
72415040|NCT02071173|144340088|SUPERIORITY|Single group test comparison to a performance goal of 75%. Lower one-sided 97.5% confidence limit was compared to the performance goal. If lower confidence limit exceeded performance goal, null hypothesis was rejected.|Percent|94.0|||||ONE_SIDED|97.5|92.0|||||||Ho: Percentage of PCT less than or equal to 2.5V ≤ 75%, Ha: Percentage of PCT less than or equal to 2.5V \> 75%|||92.0|
72415041|NCT02071173|144340089|SUPERIORITY|Single group test comparison to a performance goal of 75%. Lower one-sided 97.5% confidence limit was compared to the performance goal. If lower confidence limit exceeded performance goal, null hypothesis was rejected.|Percent|91.1|||||ONE_SIDED|97.5|88.2|||||||Ho: Percentage of PCT less than or equal to 2.5V ≤ 75%, Ha: Percentage of PCT less than or equal to 2.5V \> 75%|||88.2|
72415042|NCT02071173|144340090|SUPERIORITY|Single group test comparison to a performance goal of 93%. Lower one-sided 95% confidence limit was compared to the performance goal. If lower confidence limit exceeded performance goal, null hypothesis was rejected.|Percent|98.2|||||ONE_SIDED|95.0|97.5|||||||Ho: The Implant through 3-month lead-related complication-free rate ≤ 93%, Ha: The Implant through 3-month lead-related complication-free rate \> 93%|||97.5|
72415043|NCT02071173|144340091|SUPERIORITY|Single group test comparison to a performance goal of 94%. Lower one-sided 95% confidence limit was compared to the performance goal. If lower confidence limit exceeded performance goal, null hypothesis was rejected.|Percent|99.3|||||ONE_SIDED|95.0|98.8|||||||Ho: The 3- through 24-month lead-related complication-free rate ≤ 94%, Ha: The 3- through 24-month lead-related complication-free rate \> 94%|||98.8|
72415044|NCT02071173|144340092|SUPERIORITY|Single group test comparison to a performance goal of 1.5 Volts. Upper one-sided 95% confidence limit was compared to the performance goal. If upper confidence limit was lower than the performance goal, null hypothesis was rejected.|Mean|0.56|||||ONE_SIDED|95.0||0.58||||||Ho: The 3-month mean PCT ≥ 1.5 Volts, Ha: The 3-month mean PCT \< 1.5 Volts||0.58||
72415045|NCT02071173|144340093|SUPERIORITY|Single group test comparison to a performance goal of 3 mV. Lower one-sided 95% confidence limit was compared to the performance goal. If lower confidence limit was greater than the performance goal, null hypothesis was rejected.|Mean|17.4|||||ONE_SIDED|95.0|16.7|||||||Ho: The 3-month mean sensed amplitude ≤ 3 mV, Ha: The 3-month mean sensed amplitude \> 3 mV|||16.7|
72594629|NCT02502266|144720646|SUPERIORITY||Hazard Ratio (HR)|0.796||||0.145|TWO_SIDED|98.0|0.597|1.06||The log rank test was stratified by the factors provided at randomization|Log Rank||The hazard ratio estimate compares Cediranib and Olaparib to chemotherapy. If Cediranib and Olaparib is superior, the hazard ratio is \<1.0.|Arm IV was suspended for futility at the end of Phase 2 analysis, so was not analyzed at the final analysis.||1.060|0.597|0.145
72594630|NCT02502266|144720646|SUPERIORITY||Hazard Ratio (HR)|0.972||||1|TWO_SIDED|98.0|0.726|1.0|||Log Rank|The log rank test was stratified by the factors provided at randomization.|The hazard ratio estimate compares Cediranib to chemotherapy. If Cediranib is superior, the hazard ratio is \<1.0.|Arm IV was suspended for futility at the end of Phase 2 analysis, so was not analyzed at the final analysis.||1.00|0.726|1.0
72415046|NCT02071173|144340094|SUPERIORITY|Single group test comparison to a performance goal of 3 mV. Lower one-sided 95% confidence limit was compared to the performance goal. If lower confidence limit was greater than the performance goal, null hypothesis was rejected.|Mean|16.1|||||ONE_SIDED|97.5|15.1|||||||Ho: The 3-month mean sensed amplitude ≤ 3 mV, Ha: The 3-month mean sensed amplitude \> 3 mV|||15.1|
72415047|NCT02071173|144340095|SUPERIORITY|Single group test comparison to a performance goal of 300 ohms. Lower one-sided 95% confidence limit was compared to the performance goal. If lower confidence limit was greater than the performance goal, null hypothesis was rejected.|Mean|776.0|||||ONE_SIDED|97.5|753.0|||||||Ho: The 3-month mean pacing impedance ≤ 300 ohms, Ha: The 3-month mean pacing impedance \> 300 ohms|||753|
72594631|NCT02502266|144720647|SUPERIORITY||Hazard Ratio (HR)|1.027|||||TWO_SIDED|98.0|0.771|1.368||No p-values are provided because testing each of these null hypotheses was conditioned on first rejecting hypothesis concerning PFS.|||The hazard ratio estimate compares Cediranib and Olaparib to chemotherapy. If Cediranib and Olaparib is superior, the hazard ratio is \<1.0.|Arm IV was suspended for futility at the end of Phase 2 analysis, so was not analyzed at the final analysis.||1.368|0.771|
72594632|NCT02502266|144720647|OTHER|No p-values are provided because testing each of these null hypotheses was conditioned on first rejecting hypothesis concerning PFS.|Hazard Ratio (HR)|1.06|||||TWO_SIDED|98.0|0.795|1.413||No p-values are provided because testing each of these null hypotheses was conditioned on first rejecting hypothesis concerning PFS.|||The hazard ratio estimate compares Cediranib to chemotherapy. If Cediranib is superior, the hazard ratio is \<1.0.|Arm IV was suspended for futility at the end of Phase 2 analysis, so was not analyzed at the final analysis.||1.413|0.795|
72594633|NCT02921750|144720655|NON_INFERIORITY|In this non-inferiority study the primary efficacy analysis included constructing a two sided 95% confidence interval, using Fisher's non-parametric permutation test, for between-treatment differences (Exufiber - Aquacel Extra) in the mean percentage area change from baseline to 6 weeks. This means that if the lower limit of this confidence interval was found to be greater than 12%, non-inferiority will be established.|Mean Difference (Final Values)|-29.4||||0.093|TWO_SIDED|95.0|-63.5|3.2|||Fisher Exact|||||3.2|-63.5|0.093
72594634|NCT02304380|144720671|OTHER||Difference in differences|-0.0064|||||TWO_SIDED|95.0|-0.0469|0.034|||||Linear model difference in incidences.|||0.0340|-0.0469|
72594635|NCT02304380|144720672|OTHER||Difference in Differences|0.0506|||||TWO_SIDED|95.0|0.029|0.0722|||||Linear model difference in incidences.|||0.0722|0.0290|
72594636|NCT02304380|144720673|OTHER||Difference in Differences|-0.0005|||||TWO_SIDED|95.0|-0.0109|0.0099|||||Linear model difference in incidences.|||0.0099|-0.0109|
72594637|NCT02304380|144720674|OTHER||Difference in differences|-0.0207|||||TWO_SIDED|95.0|-0.0318|0.0096||||||||0.0096|-0.0318|
72594638|NCT02304380|144720675|OTHER||Difference in differences|0.0163|||||TWO_SIDED|95.0|0.0036|0.0289|||||Linear model difference in incidences.|||0.0289|0.0036|
72594639|NCT02304380|144720676|OTHER||Difference in differences|0.0046|||||TWO_SIDED|95.0|-0.002|0.0111|||||||Linear model difference in incidences.|0.0111|-0.0020|
72594640|NCT02304380|144720677|OTHER||Difference in differences|0.0151|||||TWO_SIDED|95.0|-0.0129|0.0431|||||Linear model difference in incidences.|||0.0431|-0.0129|
72594641|NCT02304380|144720678|OTHER||Difference in Differences|-0.0066|||||TWO_SIDED|95.0|-0.0328|0.0197|||||Linear model difference in incidences.|||0.0197|-0.0328|
72594642|NCT02304380|144720679|OTHER||Difference in Differences|-0.0105|||||TWO_SIDED|95.0|-0.0374|0.0163|||||Linear model difference in incidences.|||0.0163|-0.0374|
72415048|NCT02071173|144340096|SUPERIORITY|Single group test comparison to a performance goal of 300 ohms. Lower one-sided 95% confidence limit was compared to the performance goal. If lower confidence limit was greater than the performance goal, null hypothesis was rejected.|Mean|805.0|||||ONE_SIDED|97.5|763.0|||||||Ho: The 3-month mean pacing impedance ≤ 300 ohms, Ha: The 3-month mean pacing impedance \> 300 ohms|||763|
72415049|NCT02071173|144340097|SUPERIORITY|Single group test comparison to a performance goal of 4.5 seconds. Upper one-sided 95% confidence limit was compared to the performance goal. If upper confidence limit was lower than the performance goal, null hypothesis was rejected.|Mean|3.14|||||ONE_SIDED|95.0||3.2||||||Ho: The mean detection time ≥ 4.5 seconds, Ha: The mean detection time \< 4.5 seconds||3.20||
72415050|NCT02071173|144340098|SUPERIORITY|Single group test comparison to a performance goal of 5 mV. Lower one-sided 95% confidence limit was compared to the performance goal. If lower confidence limit was greater than the performance goal, null hypothesis was rejected.|Mean|18.3|||||ONE_SIDED|95.0|6.2|||||||Ho: The 3-month mean sensed amplitude ≤ 5 mV, Ha: The 3-month mean sensed amplitude \> 5 mV|||6.2|
72594643|NCT02304380|144720680|OTHER||Difference in Differences|0.0006|||||TWO_SIDED|95.0|-0.0031|0.0044|||||Linear model difference in incidences.|||0.0044|-0.0031|
72594644|NCT02304380|144720681|OTHER||Difference in Differences|-0.0293|||||TWO_SIDED|95.0|-0.1025|0.044||||Linear model difference in incidences.||||0.0440|-0.1025|
72594645|NCT02304380|144720682|OTHER||Difference in Differences|-0.0579|||||TWO_SIDED|95.0|-0.1492|0.0116|||||Linear model difference in incidences.|||0.0116|-0.1492|
72594646|NCT02304380|144720683|OTHER||Difference in differences|0.0072|||||TWO_SIDED|95.0|0.001|0.0134|||||Linear model difference in incidences.|||0.0134|0.0010|
72594647|NCT02304380|144720684|OTHER||Difference in Differences|0.0058|||||TWO_SIDED|95.0|0.0009|0.0107||||||||0.0107|0.0009|
72594648|NCT02304380|144720685|OTHER||Difference in Differences|0.0054|||||TWO_SIDED|95.0|0.0001|0.0106|||||Linear model difference in incidences.|||0.0106|0.0001|
72594649|NCT02304380|144720686|OTHER||Difference in Differences|-0.0039|||||TWO_SIDED|95.0|-0.0096|0.0017|||||Linear model difference in incidences.|||0.0017|-0.0096|
72594650|NCT02304380|144720687|OTHER||Difference in Differences|-0.011|||||TWO_SIDED|95.0|-0.0178|-0.0043|||||Linear model difference in incidences.|||-0.0043|-0.0178|
72594651|NCT02304380|144720688|OTHER||Difference in Differences|0.0026|||||TWO_SIDED|95.0|-0.0036|0.0086|||||Linear model difference in incidences.|||0.0086|-0.0036|
72594652|NCT02304380|144720689|OTHER||Difference in differences|0.0197|||||TWO_SIDED|95.0|0.011|0.0284|||||Linear model difference in incidences.|||0.0284|0.0110|
72594653|NCT00985426|144720697|NON_INFERIORITY|Non-inferiority is achieved if the lower limit of the two-sided 95% CI was greater than -10%.|SPR Difference (%)|8.0|||||TWO_SIDED|95.0|1.7|14.3|||||SPR difference = SPR for HEPLISAV-B minus SPR for Engerix-B.|Two-sided 95% confidence intervals (CIs) of the difference in seroprotection rates (SPR) between the HEPLISAV-B group and the Engerix-B group at 28 weeks was computed using the Newcombe score method with continuity correction.||14.3|1.7|
72594654|NCT00985426|144720697|SUPERIORITY|Superiority is achieved if the lower limit of the two-sided 95% CI was greater than 0%.|SPR Difference (%)|8.0|||||TWO_SIDED|95.0|1.7|14.3||||||Two-sided 95% CIs of the difference in SPR between the HEPLISAV-B group and the Engerix-B group at 28 weeks was computed using the Newcombe score method with continuity correction.||14.3|1.7|
72594655|NCT00985426|144720702|SUPERIORITY|Superiority is achieved if the lower limit of the two-sided 95% CI was greater than 0%.|SPR Difference (%)|12.9|||||TWO_SIDED|95.0|4.4|21.2||||||Two-sided 95% CIs of the difference in SPRs between the HEPLISAV group and the Engerix-B group at 28 weeks was computed using the Newcombe score method with continuity correction.||21.2|4.4|
72594656|NCT01149421|144720717|NON_INFERIORITY_OR_EQUIVALENCE|If non-inferiority was confirmed, then superiority analysis was pursued.|Least Squares Mean Difference|-2.79|||<|0.001|TWO_SIDED|97.3|-4.58|-1.0||P-value reported for non-inferior to Placebo. The adjustment for multiplicity was based on a tree-gatekeeping testing strategy.|Mixed Models Analysis|||||-1.00|-4.58|<0.001
72594657|NCT01149421|144720717|NON_INFERIORITY_OR_EQUIVALENCE|If non-inferiority was confirmed, then superiority analysis was pursued.|Least Squares Mean Difference|-1.07|||<|0.001|TWO_SIDED|97.3|-2.83|0.68||P-value reported for non-inferior to Placebo. The adjustment for multiplicity was based on a tree-gatekeeping testing strategy.|Mixed Models Analysis|||||0.68|-2.83|<0.001
72594658|NCT01149421|144720717|SUPERIORITY_OR_OTHER||||||<|0.001||||||Since non-inferiority was confirmed, superiority analysis was pursued. P-value reported for superior to Placebo. The adjustment for multiplicity was based on a tree-gatekeeping testing strategy.|Mixed Models Analysis|||||||<0.001
72594659|NCT01149421|144720717|SUPERIORITY_OR_OTHER|||||||0.149||||||Since non-inferiority was confirmed, superiority analysis was pursued. P-value reported for superior to Placebo. The adjustment for multiplicity was based on a tree-gatekeeping testing strategy.|Mixed Models Analysis|||||||0.149
72594660|NCT01149421|144720718|NON_INFERIORITY_OR_EQUIVALENCE|If non-inferiority was confirmed, then superiority analysis was pursued.|Least Squares Mean Difference|-2.66|||<|0.001|TWO_SIDED|97.3|-4.53|-0.79||P-value reported for non-inferior to Placebo. The adjustment for multiplicity was based on a tree-gatekeeping testing strategy.|Mixed Models Analysis|||||-0.79|-4.53|<0.001
72594661|NCT01149421|144720718|NON_INFERIORITY_OR_EQUIVALENCE|If non-inferiority was confirmed, then superiority analysis was pursued.|Least Squares Mean Difference|-1.71|||<|0.001|TWO_SIDED|97.3|-3.54|0.12||P-value reported for non-inferior to Placebo. The adjustment for multiplicity was based on a tree-gatekeeping testing strategy.|Mixed Models Analysis|||||0.12|-3.54|<0.001
72594662|NCT01149421|144720718|SUPERIORITY_OR_OTHER|||||||0.002||||||Since non-inferiority was confirmed, superiority analysis was pursued. P-value reported for superior to Placebo. The adjustment for multiplicity was based on a tree-gatekeeping testing strategy.|Mixed Models Analysis|||||||0.002
72415051|NCT02071173|144340099|OTHER|Two one-sided tests (TOST) were performed.|Mean|468.0|||||TWO_SIDED|90.0|463.0|472.0||||||Ho: Pacing impedance ≤ 300 Ω or pacing impedance ≥ 1200 Ω, Ha: 300 Ω \< Pacing impedance \< 1200 Ω||472|463|
72415052|NCT02071173|144340100|OTHER|Two one-sided tests (TOST) were performed.|Mean|702.0|||||TWO_SIDED|90.0|659.0|744.0||||||Ho: Pacing impedance ≤ 300 Ω or pacing impedance ≥ 1200 Ω, Ha: 300 Ω \< Pacing impedance \< 1200 Ω||744|659|
72594663|NCT01149421|144720718|SUPERIORITY_OR_OTHER|||||||0.36||||||Since non-inferiority was confirmed, superiority analysis was pursued. P-value reported for superior to Placebo. The adjustment for multiplicity was based on a tree-gatekeeping testing strategy.|Mixed Models Analysis|||||||0.36
72594664|NCT01149421|144720719|NON_INFERIORITY_OR_EQUIVALENCE|If non-inferiority was confirmed, then superiority analysis was pursued.|Least Squares Mean Difference|0.32|||<|0.001|TWO_SIDED|97.3|-0.8|1.43||Treatment comparison at 16 weeks. P-value reported for non-inferior to Placebo. The adjustment for multiplicity was based on a tree-gatekeeping testing strategy.|Mixed Models Analysis|||||1.43|-0.80|<0.001
72594665|NCT01149421|144720719|NON_INFERIORITY_OR_EQUIVALENCE|If non-inferiority was confirmed, then superiority analysis was pursued.|Least Squares Mean Difference|0.42|||<|0.001|TWO_SIDED|97.3|-0.67|1.52||Treatment comparison at 16 weeks. P-value reported for non-inferior to Placebo. The adjustment for multiplicity was based on a tree-gatekeeping testing strategy.|Mixed Models Analysis|||||1.52|-0.67|<0.001
72594666|NCT01149421|144720719|SUPERIORITY_OR_OTHER|||||||0.87||||||Treatment comparison at 16 weeks. Since non-inferiority was confirmed, superiority analysis was pursued. P-value reported for superior to Placebo. The adjustment for multiplicity was based on a tree-gatekeeping testing strategy.|Mixed Models Analysis|||||||0.870
72594667|NCT01149421|144720719|SUPERIORITY_OR_OTHER|||||||0.915||||||Treatment comparison at 16 weeks. Since non-inferiority was confirmed, superiority analysis was pursued. P-value reported for superior to Placebo. The adjustment for multiplicity was based on a tree-gatekeeping testing strategy.|Mixed Models Analysis|||||||0.915
72594668|NCT01149421|144720719|NON_INFERIORITY_OR_EQUIVALENCE|If non-inferiority was confirmed, then superiority analysis was pursued.|Least Squares Mean Difference|0.5|||<|0.001|TWO_SIDED|97.3|-0.68|1.68||Treatment comparison at 26 weeks. P-value reported for non-inferior to Placebo. The adjustment for multiplicity was based on a tree-gatekeeping testing strategy.|Mixed Models Analysis|||||1.68|-0.68|<0.001
72594669|NCT01149421|144720719|NON_INFERIORITY_OR_EQUIVALENCE|If non-inferiority was confirmed, then superiority analysis was pursued.|Least Squares Mean Difference|0.16|||<|0.001|TWO_SIDED|97.3|-1.0|1.31||Treatment comparison at 26 weeks. P-value reported for non-inferior to Placebo. The adjustment for multiplicity was based on a tree-gatekeeping testing strategy.|Mixed Models Analysis|||||1.31|-1.00|<0.001
72594670|NCT01149421|144720719|SUPERIORITY_OR_OTHER|||||||0.929||||||Treatment comparison at 26 weeks. Since non-inferiority was confirmed, superiority analysis was pursued. P-value reported for superior to Placebo. The adjustment for multiplicity was based on a tree-gatekeeping testing strategy.|Mixed Models Analysis|||||||0.929
72594671|NCT01149421|144720719|SUPERIORITY_OR_OTHER|||||||0.776||||||Treatment comparison at 26 weeks. Since non-inferiority was confirmed, superiority analysis was pursued. P-value reported for superior to Placebo. The adjustment for multiplicity was based on a tree-gatekeeping testing strategy.|Mixed Models Analysis|||||||0.776
72594672|NCT01149421|144720720|NON_INFERIORITY_OR_EQUIVALENCE|If non-inferiority was confirmed, then superiority analysis was pursued.|Least Squares Mean Difference|2.84||||0.556|TWO_SIDED|97.3|1.52|4.16||Treatment comparison at 16 weeks. P-value reported for non-inferior to Placebo. The adjustment for multiplicity was based on a tree-gatekeeping testing strategy.|Mixed Models Analysis|||||4.16|1.52|0.556
72594673|NCT01149421|144720720|NON_INFERIORITY_OR_EQUIVALENCE|If non-inferiority was confirmed, then superiority analysis was pursued.|Least Squares Mean Difference|1.62||||0.018|TWO_SIDED|97.3|0.32|2.92||Treatment comparison at 16 weeks. P-value reported for non-inferior to Placebo. The adjustment for multiplicity was based on a tree-gatekeeping testing strategy.|Mixed Models Analysis|||||2.92|0.32|0.018
72594674|NCT01149421|144720720|SUPERIORITY_OR_OTHER|||||||1||||||Treatment comparison at 16 weeks. Since non-inferiority was confirmed, superiority analysis was pursued. P-value reported for superior to Placebo. The adjustment for multiplicity was based on a tree-gatekeeping testing strategy.|Mixed Models Analysis|||||||1.00
72594675|NCT01149421|144720720|NON_INFERIORITY_OR_EQUIVALENCE|If non-inferiority was confirmed, then superiority analysis was pursued.|Least Squares Mean Difference|3.5||||0.904|TWO_SIDED|97.3|2.1|4.91||Treatment comparison at 26 weeks. P-value reported for non-inferior to Placebo. The adjustment for multiplicity was based on a tree-gatekeeping testing strategy.|Mixed Models Analysis|||||4.91|2.10|0.904
72594676|NCT01149421|144720720|NON_INFERIORITY_OR_EQUIVALENCE|If non-inferiority was confirmed, then superiority analysis was pursued.|Least Squares Mean Difference|1.26||||0.005|TWO_SIDED|97.3|-0.13|2.64||Treatment comparison at 26 weeks. P-value reported for non-inferior to Placebo. The adjustment for multiplicity was based on a tree-gatekeeping testing strategy.|Mixed Models Analysis|||||2.64|-0.13|0.005
72594677|NCT01149421|144720720|SUPERIORITY_OR_OTHER|||||||0.996||||||Treatment comparison at 26 weeks. Since non-inferiority was confirmed, superiority analysis was pursued. P-value reported for superior to Placebo. The adjustment for multiplicity was based on a tree-gatekeeping testing strategy.|Mixed Models Analysis|||||||0.996
72594678|NCT01149421|144720721|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.05|||<|0.001|TWO_SIDED|95.0|-4.0|-2.09||Treatment comparison at 16 weeks.|Mixed Models Analysis|||||-2.09|-4.00|<0.001
72594679|NCT01149421|144720721|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.58||||0.001|TWO_SIDED|95.0|-2.51|-0.64||Treatment comparison at 16 weeks.|Mixed Models Analysis|||||-0.64|-2.51|0.001
72594680|NCT01149421|144720721|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.1|||<|0.001|TWO_SIDED|95.0|-4.1|-2.09||Treatment comparison at 26 weeks.|Mixed Models Analysis|||||-2.09|-4.10|<0.001
72594681|NCT01149421|144720721|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.99|||<|0.001|TWO_SIDED|95.0|-2.98|-1.0||Treatment comparison at 26 weeks.|Mixed Models Analysis|||||-1.00|-2.98|<0.001
72594682|NCT01149421|144720722|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.71||||0.218|TWO_SIDED|95.0|-1.84|0.42||Treatment comparison at 16 weeks.|Mixed Models Analysis|||||0.42|-1.84|0.218
72594683|NCT01149421|144720722|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.05||||0.931|TWO_SIDED|95.0|-1.16|1.06||Treatment comparison at 16 weeks.|Mixed Models Analysis|||||1.06|-1.16|0.931
72594684|NCT01149421|144720722|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.58||||0.315|TWO_SIDED|95.0|-1.72|0.55||Treatment comparison at 26 weeks.|Mixed Models Analysis|||||0.55|-1.72|0.315
72594685|NCT01149421|144720722|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.42||||0.465|TWO_SIDED|95.0|-1.54|0.7||Treatment comparison at 26 weeks.|Mixed Models Analysis|||||0.70|-1.54|0.465
72594686|NCT01149421|144720723|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.33|||<|0.001|TWO_SIDED|95.0|-5.04|-1.61||Treatment comparison of mean daytime systolic blood pressure (SBP) at 16 weeks.|Mixed Models Analysis|||||-1.61|-5.04|<0.001
72594687|NCT01149421|144720723|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.23||||0.153|TWO_SIDED|95.0|-2.91|0.46||Treatment comparison of mean daytime systolic blood pressure (SBP) at 16 weeks.|Mixed Models Analysis|||||0.46|-2.91|0.153
72594688|NCT01149421|144720723|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.87||||0.002|TWO_SIDED|95.0|-4.66|-1.09||Treatment comparison of mean daytime systolic blood pressure (SBP) at 26 weeks.|Mixed Models Analysis|||||-1.09|-4.66|0.002
72594689|NCT01149421|144720723|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.82||||0.042|TWO_SIDED|95.0|-3.57|-0.07||Treatment comparison of mean daytime systolic blood pressure (SBP) at 26 weeks.|Mixed Models Analysis|||||-0.07|-3.57|0.042
72594690|NCT01149421|144720723|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.24||||0.221|TWO_SIDED|95.0|-3.23|0.75||Treatment comparison of mean nighttime systolic blood pressure (SBP) at 16 weeks.|Mixed Models Analysis|||||0.75|-3.23|0.221
72594691|NCT01149421|144720723|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.15||||0.884|TWO_SIDED|95.0|-2.1|1.81||Treatment comparison of mean nighttime systolic blood pressure (SBP) at 16 weeks.|Mixed Models Analysis|||||1.81|-2.10|0.884
72594692|NCT01149421|144720723|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.35||||0.19|TWO_SIDED|95.0|-4.31|-0.39||Treatment comparison of mean nighttime systolic blood pressure (SBP) at 26 weeks.|Mixed Models Analysis|||||-0.39|-4.31|0.19
72594693|NCT01149421|144720723|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.38||||0.159|TWO_SIDED|95.0|-3.31|0.54||Treatment comparison of mean nighttime systolic blood pressure (SBP) at 26 weeks.|Mixed Models Analysis|||||0.54|-3.31|0.159
72594694|NCT01149421|144720723|SUPERIORITY_OR_OTHER|||||||0.122||||||Treatment comparison of mean clinic systolic blood pressure (SBP) at 16 weeks.|Mixed Models Analysis|||||||0.122
72594695|NCT01149421|144720723|SUPERIORITY_OR_OTHER|||||||0.601||||||Treatment comparison of mean clinic systolic blood pressure (SBP) at 16 weeks.|Mixed Models Analysis|||||||0.601
72594696|NCT01149421|144720723|SUPERIORITY_OR_OTHER|||||||0.012||||||Treatment comparison of mean clinic systolic blood pressure (SBP) at 26 weeks.|Mixed Models Analysis|||||||0.012
72594697|NCT01149421|144720723|SUPERIORITY_OR_OTHER|||||||0.274||||||Treatment comparison of mean clinic systolic blood pressure (SBP) at 26 weeks.|Mixed Models Analysis|||||||0.274
72594698|NCT01149421|144720724|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.21||||0.717|TWO_SIDED|95.0|-0.91|1.32||Treatment comparison of mean daytime diastolic blood pressure (DBP) at 16 weeks.|Mixed Models Analysis|||||1.32|-0.91|0.717
72594699|NCT01149421|144720724|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.44||||0.427|TWO_SIDED|95.0|-0.65|1.54||Treatment comparison of mean daytime diastolic blood pressure (DBP) at 16 weeks.|Mixed Models Analysis|||||1.54|-0.65|0.427
72594700|NCT01149421|144720724|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.6||||0.3|TWO_SIDED|95.0|-0.53|1.73||Treatment comparison of mean daytime diastolic blood pressure (DBP) at 26 weeks.|Mixed Models Analysis|||||1.73|-0.53|0.300
72594701|NCT01149421|144720724|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.15||||0.788|TWO_SIDED|95.0|-0.96|1.26||Treatment comparison of mean daytime diastolic blood pressure (DBP) at 26 weeks.|Mixed Models Analysis|||||1.26|-0.96|0.788
72594702|NCT01149421|144720724|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.08||||0.098|TWO_SIDED|95.0|-0.2|2.37||Treatment comparison of mean nighttime diastolic blood pressure (DBP) at 16 weeks.|Mixed Models Analysis|||||2.37|-0.20|0.098
72594703|NCT01149421|144720724|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.82||||0.203|TWO_SIDED|95.0|-0.44|2.08||Treatment comparison of mean nighttime diastolic blood pressure (DBP) at 16 weeks.|Mixed Models Analysis|||||2.08|-0.44|0.203
72594704|NCT01149421|144720724|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.47||||0.493|TWO_SIDED|95.0|-0.88|1.82||Treatment comparison of mean nighttime diastolic blood pressure (DBP) at 26 weeks.|Mixed Models Analysis|||||1.82|-0.88|0.493
72594705|NCT01149421|144720724|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.27||||0.692|TWO_SIDED|95.0|-1.06|1.6||Treatment comparison of mean nighttime diastolic blood pressure (DBP) at 26 weeks.|Mixed Models Analysis|||||1.60|-1.06|0.692
72594706|NCT01149421|144720724|SUPERIORITY_OR_OTHER|||||||0.99||||||Treatment comparison of mean clinic diastolic blood pressure (DBP) at 16 weeks.|Mixed Models Analysis|||||||0.990
72594707|NCT01149421|144720724|SUPERIORITY_OR_OTHER|||||||0.173||||||Treatment comparison of mean clinic diastolic blood pressure (DBP) at 16 weeks.|Mixed Models Analysis|||||||0.173
72594708|NCT01149421|144720724|SUPERIORITY_OR_OTHER|||||||0.972||||||Treatment comparison of mean clinic diastolic blood pressure (DBP) at 26 weeks.|Mixed Models Analysis|||||||0.972
72594709|NCT01149421|144720724|SUPERIORITY_OR_OTHER|||||||0.904||||||Treatment comparison of mean clinic diastolic blood pressure (DBP) at 26 weeks.|Mixed Models Analysis|||||||0.904
72594710|NCT01149421|144720725|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.49|||<|0.001|TWO_SIDED|95.0|1.17|3.8||Treatment comparison of mean daytime heart rate (HR) at 16 weeks.|Mixed Models Analysis|||||3.80|1.17|<0.001
72594711|NCT01149421|144720725|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.15||||0.08|TWO_SIDED|95.0|-0.14|2.45||Treatment comparison of mean daytime heart rate (HR) at 16 weeks.|Mixed Models Analysis|||||2.45|-0.14|0.080
72594712|NCT01149421|144720725|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.57|||<|0.001|TWO_SIDED|95.0|2.23|4.91||Treatment comparison of mean daytime heart rate (HR) at 26 weeks.|Mixed Models Analysis|||||4.91|2.23|<0.001
72594713|NCT01149421|144720725|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.92||||0.168|TWO_SIDED|95.0|-0.39|2.24||Treatment comparison of mean daytime heart rate (HR) at 26 weeks.|Mixed Models Analysis|||||2.24|-0.39|0.168
72594714|NCT01149421|144720725|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.95|||<|0.001|TWO_SIDED|95.0|2.62|5.28||Treatment comparison of mean nighttime heart rate (HR) at 16 weeks.|Mixed Models Analysis|||||5.28|2.62|<0.001
72415053|NCT02071173|144340101|SUPERIORITY|Single group test comparison to a performance goal of 93%. Lower one-sided 95% confidence limit was compared to the performance goal. If lower confidence limit was greater than the performance goal, null hypothesis was rejected.|Percent|99.5|||||ONE_SIDED|95.0|98.4|||||||Ho: Percent of successful conversion ≤ 93%, Ha: Percent of successful conversion \> 93%|||98.4|
72594715|NCT01149421|144720725|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.78|||<|0.001|TWO_SIDED|95.0|1.47|4.09||Treatment comparison of mean nighttime heart rate (HR) at 16 weeks.|Mixed Models Analysis|||||4.09|1.47|<0.001
72594716|NCT01149421|144720725|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.98|||<|0.001|TWO_SIDED|95.0|2.49|5.47||Treatment comparison of mean nighttime heart rate (HR) at 26 weeks.|Mixed Models Analysis|||||5.47|2.49|<0.001
72594717|NCT01149421|144720725|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.24||||0.003|TWO_SIDED|95.0|0.78|3.7||Treatment comparison of mean nighttime heart rate (HR) at 26 weeks.|Mixed Models Analysis|||||3.70|0.78|0.003
72594718|NCT01149421|144720725|SUPERIORITY_OR_OTHER||||||<|0.001||||||Treatment comparison of mean clinic heart rate (HR) at 16 weeks.|Mixed Models Analysis|||||||<0.001
72594719|NCT01149421|144720725|SUPERIORITY_OR_OTHER|||||||0.014||||||Treatment comparison of mean clinic heart rate (HR) at 16 weeks.|Mixed Models Analysis|||||||0.014
72594720|NCT01149421|144720725|SUPERIORITY_OR_OTHER||||||<|0.001||||||Treatment comparison of mean clinic heart rate (HR) at 26 weeks.|Mixed Models Analysis|||||||<0.001
72594721|NCT01149421|144720725|SUPERIORITY_OR_OTHER|||||||0.005||||||Treatment comparison of mean clinic heart rate (HR) at 26 weeks.|Mixed Models Analysis|||||||0.005
72594722|NCT01149421|144720726|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.47|||<|0.001|TWO_SIDED|95.0|-4.5|-2.43||Treatment comparison of mean daytime pulse pressure (PP) at 16 weeks.|Mixed Models Analysis|||||-2.43|-4.50|<0.001
72594723|NCT01149421|144720726|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.77|||<|0.001|TWO_SIDED|95.0|-2.79|-0.75||Treatment comparison of mean daytime pulse pressure (PP) at 16 weeks.|Mixed Models Analysis|||||-0.75|-2.79|<0.001
72594724|NCT01149421|144720726|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.4|||<|0.001|TWO_SIDED|95.0|-4.52|-2.28||Treatment comparison of mean daytime pulse pressure (PP) at 26 weeks.|Mixed Models Analysis|||||-2.28|-4.52|<0.001
72594725|NCT01149421|144720726|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.13|||<|0.001|TWO_SIDED|95.0|-3.23|-1.03||Treatment comparison of mean daytime pulse pressure (PP) at 26 weeks.|Mixed Models Analysis|||||-1.03|-3.23|<0.001
72594726|NCT01149421|144720726|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.25|||<|0.001|TWO_SIDED|95.0|-3.43|-1.07||Treatment comparison of mean nighttime pulse pressure (PP) at 16 weeks.|Mixed Models Analysis|||||-1.07|-3.43|<0.001
72594727|NCT01149421|144720726|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.93||||0.113|TWO_SIDED|95.0|-2.09|0.22||Treatment comparison of mean nighttime pulse pressure (PP) at 16 weeks.|Mixed Models Analysis|||||0.22|-2.09|0.113
72594728|NCT01149421|144720726|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.74|||<|0.001|TWO_SIDED|95.0|-3.86|-1.62||Treatment comparison of mean nighttime pulse pressure (PP) at 26 weeks.|Mixed Models Analysis|||||-1.62|-3.86|<0.001
72594729|NCT01149421|144720726|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.61||||0.004|TWO_SIDED|95.0|-2.72|-0.51||Treatment comparison of mean nighttime pulse pressure (PP) at 26 weeks.|Mixed Models Analysis|||||-0.51|-2.72|0.004
72594730|NCT01149421|144720727|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.97||||0.128|TWO_SIDED|95.0|-2.22|0.28||Treatment comparison of mean daytime mean arterial pressure (MAP) at 16 weeks.|Mixed Models Analysis|||||0.28|-2.22|0.128
72594731|NCT01149421|144720727|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.09||||0.883|TWO_SIDED|95.0|-1.32|1.13||Treatment comparison of mean daytime mean arterial pressure (MAP) at 16 weeks.|Mixed Models Analysis|||||1.13|-1.32|0.883
72594732|NCT01149421|144720727|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.56||||0.39|TWO_SIDED|95.0|-1.84|0.72||Treatment comparison of mean daytime mean arterial pressure (MAP) at 26 weeks.|Mixed Models Analysis|||||0.72|-1.84|0.390
72594733|NCT01149421|144720727|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.47||||0.463|TWO_SIDED|95.0|-1.72|0.79||Treatment comparison of mean daytime mean arterial pressure (MAP) at 26 weeks.|Mixed Models Analysis|||||0.79|-1.72|0.463
72594734|NCT01149421|144720727|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.31||||0.671|TWO_SIDED|95.0|-1.13|1.76||Treatment comparison of mean nighttime mean arterial pressure (MAP) at 16 weeks.|Mixed Models Analysis|||||1.76|-1.13|0.671
72594735|NCT01149421|144720727|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.52||||0.471|TWO_SIDED|95.0|-0.9|1.95||Treatment comparison of mean nighttime mean arterial pressure (MAP) at 16 weeks.|Mixed Models Analysis|||||1.95|-0.90|0.471
72594736|NCT01149421|144720727|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.46||||0.543|TWO_SIDED|95.0|-1.95|1.03||Treatment comparison of mean nighttime mean arterial pressure (MAP) at 26 weeks.|Mixed Models Analysis|||||1.03|-1.95|0.543
72594737|NCT01149421|144720727|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.26||||0.728|TWO_SIDED|95.0|-1.72|1.2||Treatment comparison of mean nighttime mean arterial pressure (MAP) at 26 weeks.|Mixed Models Analysis|||||1.20|-1.72|0.728
72594738|NCT01149421|144720740|SUPERIORITY_OR_OTHER||||||<|0.001||||||Treatment comparison at 16 weeks.|Mixed Models Analysis|||||||<0.001
72594739|NCT01149421|144720740|SUPERIORITY_OR_OTHER|||||||0.005||||||Treatment comparison at 16 weeks.|Mixed Models Analysis|||||||0.005
72594740|NCT01149421|144720740|SUPERIORITY_OR_OTHER||||||<|0.001||||||Treatment comparison at 26 weeks.|Mixed Models Analysis|||||||<0.001
72594741|NCT01149421|144720740|SUPERIORITY_OR_OTHER|||||||0.012||||||Treatment comparison at 26 weeks.|Mixed Models Analysis|||||||0.012
72594742|NCT04108988|144720746|SUPERIORITY|||||||0.248|||||||Chi-squared|||P value at 4 months||||0.248
72594743|NCT04108988|144720746|SUPERIORITY|||||||0.022|||||||Chi-squared|||P value at 1 month||||0.022
72594744|NCT04108988|144720746|SUPERIORITY|||||||0.193|||||||Chi-squared|||P value at baseline||||0.193
72594745|NCT04108988|144720747|SUPERIORITY|||||||0.246|||||||Chi-squared|||P value at 4 months||||0.246
72594746|NCT04108988|144720747|SUPERIORITY|||||||0.467|||||||Chi-squared|||P value at 1 month||||0.467
72594747|NCT04108988|144720747|SUPERIORITY|||||||0.55|||||||Chi-squared|||P value at baseline||||0.550
72415054|NCT04118348|144340106|SUPERIORITY||Odds Ratio (OR)|5.73|||<|0.001|TWO_SIDED|95.0|4.46|7.36|||Regression, Logistic||BPA+HMT is the numerator|Passive control was set as the reference group.||7.36|4.46|<.001
72415055|NCT04118348|144340106|SUPERIORITY||Odds Ratio (OR)|4.87|||<|0.001|TWO_SIDED|95.0|3.79|6.27|||Regression, Logistic||BPA-only is the numerator|Passive control was set as the reference group.||6.27|3.79|<.001
72415056|NCT04118348|144340106|SUPERIORITY||Odds Ratio (OR)|1.67|||<|0.001|TWO_SIDED|95.0|1.28|2.19|||Regression, Logistic||HMT-only is the numerator|Passive control was set as the reference group.||2.19|1.28|<.001
72415057|NCT04118348|144340106|SUPERIORITY||Odds Ratio (OR)|3.43|||<|0.001|TWO_SIDED|95.0|2.73|4.29|||Regression, Logistic||BPA+HMT is the numerator|HMT was set as the reference group.||4.29|2.73|<.001
72415058|NCT04118348|144340106|SUPERIORITY||Odds Ratio (OR)|2.92|||<|0.001|TWO_SIDED|95.0|2.32|3.66|||Regression, Logistic||BPA-only is the numerator|HMT was set as the reference group.||3.66|2.32|<.001
72415059|NCT04118348|144340106|SUPERIORITY||Odds Ratio (OR)|1.17||||0.114|TWO_SIDED|95.0|0.96|1.43|||Regression, Logistic||BPA+HMT is the numerator|BPA was set as the reference group.||1.43|0.96|.114
72415060|NCT04118348|144340107|SUPERIORITY||Odds Ratio (OR)|2.9|||<|0.001|TWO_SIDED|95.0|2.02|4.15|||Regression, Logistic||BPA+HMT is the numerator|Passive control was set as the reference group.||4.15|2.02|<.001
72415061|NCT04118348|144340107|SUPERIORITY||Odds Ratio (OR)|2.28|||<|0.001|TWO_SIDED|95.0|1.57|3.3|||Regression, Logistic||BPA-only is the numerator|Passive control was set as the reference group.||3.30|1.57|<.001
72594748|NCT04108988|144720748|SUPERIORITY|||||||0.596|||||||Chi-squared|||P value at month 4||||0.596
72594749|NCT04108988|144720748|SUPERIORITY|||||||0.974|||||||Chi-squared|||P value at 1 month||||0.974
72594750|NCT04108988|144720748|SUPERIORITY|||||||0.651|||||||Chi-squared|||P value at baseline.||||0.651
72594751|NCT04108988|144720749|SUPERIORITY|||||||0.089|||||||ANOVA|Test for the interaction between treatment and time.||Test for the interaction between treatment and time.||||0.089
72594752|NCT04108988|144720750|SUPERIORITY|||||||0.095|||||||ANOVA|Test for the interaction between treatment and time.||Test for the interaction between treatment and time.||||0.095
72594753|NCT04108988|144720751|SUPERIORITY|||||||0.136|||||||ANOVA|Test for the interaction between treatment and time.||Test for the interaction between treatment and time.||||0.136
72594754|NCT04108988|144720752|SUPERIORITY|||||||0.133|||||||ANOVA|Test for the interaction between treatment and time.||Test for the interaction between treatment and time.||||0.133
72594755|NCT04108988|144720753|SUPERIORITY|||||||0.21|||||||ANOVA|Test for the interaction between treatment and time.||Test for the interaction between treatment and time.||||0.210
72594756|NCT04108988|144720754|SUPERIORITY|||||||0.392|||||||ANOVA|Test for the interaction between treatment and time.||Test for the interaction between treatment and time.||||0.392
72594757|NCT04108988|144720755|SUPERIORITY|||||||0.411|||||||ANOVA|Test for the interaction between treatment and time.||Test for the interaction between treatment and time.||||0.411
72594758|NCT04108988|144720756|SUPERIORITY|||||||0.294|||||||ANOVA|Test for the interaction between treatment and time.||Test for the interaction between treatment and time.||||0.294
72594759|NCT04108988|144720757|SUPERIORITY|||||||0.031|||||||ANOVA|Test for the interaction between treatment and time.||Test for the interaction between treatment and time.||||0.031
72594760|NCT04108988|144720758|SUPERIORITY|||||||0.262|||||||ANOVA|Test for the interaction between treatment and time||Test of interaction with treatment and time.||||0.262
72594761|NCT04108988|144720759|SUPERIORITY|||||||0.116|||||||ANOVA|Test for the interaction between treatment and time.||Test for the interaction between treatment and time.||||0.116
72594762|NCT04108988|144720760|SUPERIORITY|||||||0.016|||||||ANOVA|Test for the interaction between treatment and time.||Test for the interaction between treatment and time.||||0.016
72594763|NCT04108988|144720761|SUPERIORITY|||||||0.667|||||||ANOVA|Test for the interaction between treatment and time.||Test for the interaction between treatment and time.||||0.667
72594764|NCT04108988|144720762|SUPERIORITY|||||||0.09|||||||Chi-squared|||P value at month 4||||0.09
72594765|NCT04108988|144720762|SUPERIORITY|||||||0.72|||||||Chi-squared|||P value 1 month||||0.72
72594766|NCT04108988|144720762|SUPERIORITY|||||||0.97|||||||Chi-squared|||P value at baseline||||0.97
72594767|NCT04108988|144720763|SUPERIORITY|||||||0.53|||||||Chi-squared|||P value at month 4||||0.53
72594768|NCT04108988|144720763|SUPERIORITY|||||||0.303|||||||Chi-squared|||P value at month 1||||0.303
72594769|NCT04108988|144720763|SUPERIORITY|||||||0.042|||||||Chi-squared|||P value at baseline.||||0.042
72594770|NCT04108988|144720764|SUPERIORITY|||||||0.246|||||||Chi-squared|||P value at month 4.||||0.246
72594771|NCT04108988|144720764|SUPERIORITY|||||||0.467|||||||Chi-squared|||P value at month 1.||||0.467
72594772|NCT04108988|144720764|SUPERIORITY|||||||0.55|||||||Chi-squared|||P value at baseline.||||0.55
72594773|NCT04108988|144720765|SUPERIORITY|||||||0.987|||||||Chi-squared|||P value at month 4.||||0.987
72594774|NCT04108988|144720765|SUPERIORITY|||||||0.898|||||||Chi-squared|||P value at month 1.||||0.898
72594775|NCT04108988|144720765|SUPERIORITY|||||||0.238|||||||Chi-squared|||P value at baseline.||||0.238
72594776|NCT04108988|144720766|SUPERIORITY|||||||0.148|||||||Chi-squared|||P value at month 4.||||0.148
72594777|NCT04108988|144720766|SUPERIORITY|||||||0.557|||||||Chi-squared|||P value at month 1.||||0.557
72594778|NCT04108988|144720767|SUPERIORITY|||||||0.653|||||||Chi-squared|||||||0.653
72594779|NCT04108988|144720768|SUPERIORITY|||||||0.977|||||||Chi-squared|||||||0.977
72594780|NCT04108988|144720769|SUPERIORITY|||||||0.735|||||||t-test, 2 sided|||P value at month 4.||||0.735
72594781|NCT04108988|144720769|SUPERIORITY|||||||0.159|||||||t-test, 2 sided|||P value at month 1.||||0.159
72594782|NCT04108988|144720770|SUPERIORITY|||||||3.19|||||||t-test, 2 sided|||P value at month 4.||||3.19
72594783|NCT04108988|144720770|SUPERIORITY|||||||0.487|||||||t-test, 2 sided|||P value at month 1.||||0.487
72594784|NCT04108988|144720770|SUPERIORITY|||||||0.165|||||||t-test, 2 sided|||P value at baseline.||||0.165
72594785|NCT04108988|144720771|SUPERIORITY|||||||0.473|||||||t-test, 2 sided|||P value at month 4.||||0.473
72594786|NCT04108988|144720771|SUPERIORITY|||||||0.316|||||||t-test, 2 sided|||P value at month 1.||||0.316
72594787|NCT04108988|144720771|SUPERIORITY|||||||0.345|||||||t-test, 2 sided|||P value at baseline.||||0.345
72594788|NCT04108988|144720772|SUPERIORITY|||||||0.141|||||||t-test, 2 sided|||P value at month 4.||||0.141
72415062|NCT04118348|144340107|SUPERIORITY||Odds Ratio (OR)|1.54||||0.03|TWO_SIDED|95.0|1.04|2.27|||Regression, Logistic||HMT-only is the numerator|Passive control was set as the reference group.||2.27|1.04|.030
72594789|NCT04108988|144720772|SUPERIORITY|||||||0.314|||||||t-test, 2 sided|||P value at month 1.||||0.314
72594790|NCT04108988|144720772|SUPERIORITY|||||||0.444|||||||t-test, 2 sided|||P value at baseline.||||0.444
72594791|NCT00676572|144720781|SUPERIORITY||||||<|0.05||||||calculated p values|t-test, 2 sided|||||||<0.05
72594792|NCT04679051|144720785|SUPERIORITY|||||||0.36|||||||t-test, 2 sided|||Two-tailed paired t-tests were used to compare variables between time in bed conditions.||||0.36
72594793|NCT04679051|144720786|SUPERIORITY|||||||0.51|||||||t-test, 2 sided|||Paired t-test comparing the two time in bed protocols.||||0.51
72594794|NCT04679051|144720787|SUPERIORITY|||||||0.03|||||||t-test, 2 sided|||Paired t-test comparing peak forearm blood flow between sleep protocols.||||0.03
72594795|NCT04679051|144720788|SUPERIORITY|||||||0.29|||||||t-test, 2 sided|||Paired t-test used to compare carotid-femoral pulse wave velocity (index of arterial stiffness) between sleep protocols.||||0.29
72594796|NCT04679051|144720789|SUPERIORITY||||||<|0.001||||||Null hypothesis is that there was no difference in change of spatial ability following one day of aerobic exercise. The ANOVA test was performed with a significance level of 0.05 (two-sided).|ANOVA|||A two-way repeated measures ANOVA was used to evaluate the main effect of exercise (before vs. after exercise) on Manikin throughput scores.||||<0.001
72594797|NCT04679051|144720790|SUPERIORITY|||||||0.04||||||Null hypothesis is that there was no difference in the change of executive function following one day of aerobic exercise. The ANOVA test was performed with a significance level of 0.05 (two-sided).|ANOVA|||A two-way repeated measures ANOVA was used to evaluate the main effect of exercise (before vs. after exercise) on the number of correct answers during a Stroop color-word test.||||0.04
72594798|NCT04679051|144720791|SUPERIORITY|||||||0.02||||||Null hypothesis is that there was no difference in change of spatial ability following one day of aerobic exercise. The ANOVA test was performed with a significance level of 0.05 (two-sided).|ANOVA|||A two-way repeated measures ANOVA was used to evaluate the main effect of exercise (before vs. after exercise) on throughput scores from a Switching task.||||0.02
72594799|NCT00033657|144720793|SUPERIORITY_OR_OTHER_LEGACY|||||||0.48|TWO_SIDED|95.0|||||Log Rank|||||||0.48
72594800|NCT02945254|144720803|SUPERIORITY|||||||0.011||||||P\<0.05 considered statistically significant|Wilcoxon (Mann-Whitney)|||||||0.011
72594801|NCT02945254|144720804|SUPERIORITY|||||||0.13||||||P\<0.05 considered statistically significant|Wilcoxon (Mann-Whitney)|||||||0.13
72594802|NCT02631070|144720806|SUPERIORITY||Common Risk Difference on Response Rate|24.56|||<|0.0001|TWO_SIDED|95.0|14.48|34.64|||Cochran-Mantel-Haenszel|||||34.64|14.48|<0.0001
72594803|NCT02631070|144720806|SUPERIORITY||Odds Ratio (OR)|5.065|||<|0.0001|TWO_SIDED|95.0|2.278|11.259|||Cochran-Mantel-Haenszel|||||11.259|2.278|<0.0001
72594804|NCT02631070|144720807|SUPERIORITY||Common Risk Difference on Response Rate|20.0||||0.0002|TWO_SIDED|95.0|10.92|29.08|||Cochran-Mantel-Haenszel|||||29.08|10.92|0.0002
72594805|NCT02631070|144720807|SUPERIORITY||Odds Ratio (OR)|5.071||||0.0002|TWO_SIDED|95.0|2.002|12.844|||Cochran-Mantel-Haenszel|||||12.844|2.002|0.0002
72594806|NCT02631070|144720808|SUPERIORITY||Common Risk Difference on Response Rate|21.37||||0.0003|TWO_SIDED|95.0|11.23|31.51|||Cochran-Mantel-Haenszel|||||31.51|11.23|0.0003
72594807|NCT02631070|144720808|SUPERIORITY||Odds Ratio (OR)|4.045||||0.0003|TWO_SIDED|95.0|1.827|8.956|||Cochran-Mantel-Haenszel|||||8.956|1.827|0.0003
72594808|NCT02631070|144720809|SUPERIORITY||Common Risk Difference on Response Rate|29.55|||<|0.0001|TWO_SIDED|95.0|18.73|40.36|||Cochran-Mantel-Haenszel|||||40.36|18.73|<0.0001
72594809|NCT02631070|144720809|SUPERIORITY||Odds Ratio (OR)|5.306|||<|0.0001|TWO_SIDED|95.0|2.526|11.146|||Cochran-Mantel-Haenszel|||||11.146|2.526|<0.0001
72594810|NCT02631070|144720811|SUPERIORITY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||Week 1 -24||||<0.0001
72594811|NCT02631070|144720811|SUPERIORITY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||Week 1 - 48||||<0.0001
72594812|NCT02631070|144720812|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||Week 1 Through Week 24||||<0.0001
72594813|NCT02631070|144720812|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||Week 1 Through Week 48||||<0.0001
72594814|NCT02631070|144720813|SUPERIORITY||Hazard Ratio (HR)|0.446||||0.0445|TWO_SIDED|95.0|0.196|1.013|||Log Rank||HR is from the Cox proportional hazards model|||1.013|0.196|0.0445
72594815|NCT02631070|144720814|SUPERIORITY||Hazard Ratio (HR)|0.784||||0.5121|TWO_SIDED|95.0|0.362|1.699|||Log Rank||HR is from the Cox proportional hazards model|||1.699|0.362|0.5121
72594816|NCT02631070|144720816|SUPERIORITY|||||||0.2382|||||||Cochran-Mantel-Haenszel|||Week 1 -24||||0.2382
72594817|NCT02631070|144720816|SUPERIORITY|||||||0.5127|||||||Cochran-Mantel-Haenszel|||Week 1 - 48||||0.5127
72594818|NCT02631070|144720817|SUPERIORITY|||||||0.5479|||||||Cochran-Mantel-Haenszel|||Week 1 -24||||0.5479
72594819|NCT02631070|144720817|SUPERIORITY|||||||0.298|||||||Cochran-Mantel-Haenszel|||Week 1 - 48||||0.2980
72594820|NCT02631070|144720818|SUPERIORITY||LS Mean Difference|-229.1|STANDARD_ERROR_OF_MEAN|74.43||0.0024|TWO_SIDED|95.0|-375.8|-82.4|||ANCOVA|||Week 9 Through 24||-82.4|-375.8|0.0024
72594821|NCT02631070|144720818|SUPERIORITY||LS Mean Difference|-319.5|STANDARD_ERROR_OF_MEAN|144.57||0.0294|TWO_SIDED|95.0|-606.3|-32.7|||ANCOVA|||Week 33 Through 48||-32.7|-606.3|0.0294
72594822|NCT02631070|144720819|SUPERIORITY||LS Mean Difference|-41.0|STANDARD_ERROR_OF_MEAN|40.18||0.3087|TWO_SIDED|95.0|-120.3|38.2|||ANCOVA|||Weeks 9 Through 24||38.2|-120.3|0.3087
72594823|NCT02631070|144720819|SUPERIORITY||LS Mean Difference|-24.9|STANDARD_ERROR_OF_MEAN|93.42||0.7903|TWO_SIDED|95.0|-210.7|160.8|||ANCOVA|||Weeks 33 Through 48||160.8|-210.7|0.7903
72594824|NCT02631070|144720824|SUPERIORITY||Hazard Ratio (HR)|0.986||||0.958|TWO_SIDED|95.0|0.595|1.636|||Log Rank||HR is from the Cox proportional hazards model|||1.636|0.595|0.9580
72594825|NCT01273155|144720851|OTHER|Belinostat|Kendall's Tau|0.096||||0.327|TWO_SIDED||||||Jonckheere-Terpstra|||Effects of liver dysfunction on PK parameter values were evaluated with SPSS 22.0 for Windows (SPSS Inc., Chicago, IL), using the Jonckheere-Terpstra and Kendall's Tau test. Data were considered significantly different when p\<0.05.||||0.327
72594826|NCT01273155|144720851|OTHER|Belinostat glucuronide|Kendall's Tau|-0.178||||0.063|TWO_SIDED||||||Jonckheere-Terpstra|||Effects of liver dysfunction on PK parameter values were evaluated with SPSS 22.0 for Windows (SPSS Inc., Chicago, IL), using the Jonckheere-Terpstra and Kendall's Tau test. Data were considered significantly different when p\<0.05.||||0.063
72594827|NCT01273155|144720851|OTHER|Methyl belinostat|Kendall's Tau|0.382|||<|0.001|TWO_SIDED||||||Jonckheere-Terpstra|||Effects of liver dysfunction on PK parameter values were evaluated with SPSS 22.0 for Windows (SPSS Inc., Chicago, IL), using the Jonckheere-Terpstra and Kendall's Tau test. Data were considered significantly different when p\<0.05.||||<0.001
72594828|NCT01273155|144720851|OTHER|M21|Kendall's Tau|0.253||||0.009|TWO_SIDED||||||Jonckheere-Terpstra|||Effects of liver dysfunction on PK parameter values were evaluated with SPSS 22.0 for Windows (SPSS Inc., Chicago, IL), using the Jonckheere-Terpstra and Kendall's Tau test. Data were considered significantly different when p\<0.05.||||0.009
72594829|NCT01273155|144720851|OTHER|M24|Kendall's Tau|-0.278||||0.004|TWO_SIDED||||||Jonckheere-Terpstra|||Effects of liver dysfunction on PK parameter values were evaluated with SPSS 22.0 for Windows (SPSS Inc., Chicago, IL), using the Jonckheere-Terpstra and Kendall's Tau test. Data were considered significantly different when p\<0.05.||||0.004
72594830|NCT01273155|144720851|OTHER|M26|Kendall's Tau|0.098||||0.312|TWO_SIDED||||||Jonckheere-Terpstra|||Effects of liver dysfunction on PK parameter values were evaluated with SPSS 22.0 for Windows (SPSS Inc., Chicago, IL), using the Jonckheere-Terpstra and Kendall's Tau test. Data were considered significantly different when p\<0.05.||||0.312
72594831|NCT01273155|144720852|OTHER|Belinostat|Kendall's Tau|0.215||||0.025|TWO_SIDED||||||Jonckheere-Terpstra|||Effects of liver dysfunction on PK parameter values were evaluated with SPSS 22.0 for Windows (SPSS Inc., Chicago, IL), using the Jonckheere-Terpstra and Kendall's Tau test. Data were considered significantly different when p\<0.05.||||0.025
72594832|NCT01273155|144720852|OTHER|Methyl belinostat|Kendall's Tau|0.426|||<|0.001|TWO_SIDED||||||Jonckheere-Terpstra|||Effects of liver dysfunction on PK parameter values were evaluated with SPSS 22.0 for Windows (SPSS Inc., Chicago, IL), using the Jonckheere-Terpstra and Kendall's Tau test. Data were considered significantly different when p\<0.05.||||<0.001
72594833|NCT01273155|144720852|OTHER|M21|Kendall's Tau|0.337|||<|0.001|TWO_SIDED||||||Jonckheere-Terpstra|||Effects of liver dysfunction on PK parameter values were evaluated with SPSS 22.0 for Windows (SPSS Inc., Chicago, IL), using the Jonckheere-Terpstra and Kendall's Tau test. Data were considered significantly different when p\<0.05.||||<0.001
72594834|NCT01273155|144720852|OTHER|M24|Kendall's Tau|-0.061||||0.524|TWO_SIDED||||||Jonckheere-Terpstra|||Effects of liver dysfunction on PK parameter values were evaluated with SPSS 22.0 for Windows (SPSS Inc., Chicago, IL), using the Jonckheere-Terpstra and Kendall's Tau test. Data were considered significantly different when p\<0.05.||||0.524
72594835|NCT01273155|144720852|OTHER|M26|Kendall's Tau|0.246||||0.01|TWO_SIDED||||||Jonckheere-Terpstra|||Effects of liver dysfunction on PK parameter values were evaluated with SPSS 22.0 for Windows (SPSS Inc., Chicago, IL), using the Jonckheere-Terpstra and Kendall's Tau test. Data were considered significantly different when p\<0.05.||||0.010
72594836|NCT01273155|144720853|OTHER||Kendall's Tau|0.057||||0.548|TWO_SIDED||||||Jonckheere-Terpstra|||Effects of liver dysfunction on PK parameter values were evaluated with SPSS 22.0 for Windows (SPSS Inc., Chicago, IL), using the Jonckheere-Terpstra and Kendall's Tau test. Data were considered significantly different when p\<0.05.||||0.548
72594837|NCT01273155|144720854|OTHER|Belinostat|Kendall's Tau|0.091||||0.34|TWO_SIDED||||||Jonckheere-Terpstra|||Effects of liver dysfunction on PK parameter values were evaluated with SPSS 22.0 for Windows (SPSS Inc., Chicago, IL), using the Jonckheere-Terpstra and Kendall's Tau test. Data were considered significantly different when p\<0.05.||||0.340
72594838|NCT01273155|144720854|OTHER|Belinostat glucuronide|Kendall's Tau|-0.216||||0.023|TWO_SIDED||||||Jonckheere-Terpstra|||Effects of liver dysfunction on PK parameter values were evaluated with SPSS 22.0 for Windows (SPSS Inc., Chicago, IL), using the Jonckheere-Terpstra and Kendall's Tau test. Data were considered significantly different when p\<0.05.||||0.023
72594839|NCT01273155|144720854|OTHER|Methyl belinostat|Kendall's Tau|0.268||||0.005|TWO_SIDED||||||Jonckheere-Terpstra|||Effects of liver dysfunction on PK parameter values were evaluated with SPSS 22.0 for Windows (SPSS Inc., Chicago, IL), using the Jonckheere-Terpstra and Kendall's Tau test. Data were considered significantly different when p\<0.05.||||0.005
72594840|NCT01273155|144720854|OTHER|M21|Kendall's Tau|0.242||||0.011|TWO_SIDED||||||Jonckheere-Terpstra|||Effects of liver dysfunction on PK parameter values were evaluated with SPSS 22.0 for Windows (SPSS Inc., Chicago, IL), using the Jonckheere-Terpstra and Kendall's Tau test. Data were considered significantly different when p\<0.05.||||0.011
72594841|NCT01273155|144720854|OTHER|M24|Kendall's Tau|-0.114||||0.231|TWO_SIDED||||||Jonckheere-Terpstra|||Effects of liver dysfunction on PK parameter values were evaluated with SPSS 22.0 for Windows (SPSS Inc., Chicago, IL), using the Jonckheere-Terpstra and Kendall's Tau test. Data were considered significantly different when p\<0.05.||||0.231
72594842|NCT01273155|144720854|OTHER|M26|Kendall's Tau|0.22||||0.021|TWO_SIDED||||||Jonckheere-Terpstra|||Effects of liver dysfunction on PK parameter values were evaluated with SPSS 22.0 for Windows (SPSS Inc., Chicago, IL), using the Jonckheere-Terpstra and Kendall's Tau test. Data were considered significantly different when p\<0.05.||||0.021
72594843|NCT01273155|144720855|OTHER||Kendall's Tau|-0.216||||0.023|TWO_SIDED||||||Jonckheere-Terpstra|||Effects of liver dysfunction on PK parameter values were evaluated with SPSS 22.0 for Windows (SPSS Inc., Chicago, IL), using the Jonckheere-Terpstra and Kendall's Tau test. Data were considered significantly different when p\<0.05.||||0.023
72594844|NCT01273155|144720856|OTHER||Kendall's Tau|0.06||||0.531|TWO_SIDED||||||Jonckheere-Terpstra|||Effects of liver dysfunction on PK parameter values were evaluated with SPSS 22.0 for Windows (SPSS Inc., Chicago, IL), using the Jonckheere-Terpstra and Kendall's Tau test. Data were considered significantly different when p\<0.05.||||0.531
72594845|NCT01273155|144720857|OTHER|Belinostat glucuronide/belinostat|Kendall's Tau|-0.224||||0.023|TWO_SIDED||||||Jonckheere-Terpstra|||Effects of liver dysfunction on PK parameter values were evaluated with SPSS 22.0 for Windows (SPSS Inc., Chicago, IL), using the Jonckheere-Terpstra and Kendall's Tau test. Data were considered significantly different when p\<0.05.||||0.023
72594846|NCT01273155|144720857|OTHER|Methyl belinostat/belinostat|Kendall's Tau|0.295||||0.011|TWO_SIDED||||||Jonckheere-Terpstra|||Effects of liver dysfunction on PK parameter values were evaluated with SPSS 22.0 for Windows (SPSS Inc., Chicago, IL), using the Jonckheere-Terpstra and Kendall's Tau test. Data were considered significantly different when p\<0.05.||||0.011
72415063|NCT04118348|144340107|SUPERIORITY||Odds Ratio (OR)|1.88|||<|0.001|TWO_SIDED|95.0|1.37|2.59|||Regression, Logistic||BPA+HMT is the numerator|HMT was set as the reference group.||2.59|1.37|<.001
72594847|NCT01273155|144720857|OTHER|M21/belinostat|Kendall's Tau|0.335||||0.004|TWO_SIDED||||||Jonckheere-Terpstra|||Effects of liver dysfunction on PK parameter values were evaluated with SPSS 22.0 for Windows (SPSS Inc., Chicago, IL), using the Jonckheere-Terpstra and Kendall's Tau test. Data were considered significantly different when p\<0.05.||||0.004
72594848|NCT01273155|144720857|OTHER|M24/belinostat|Kendall's Tau|-0.24||||0.037|TWO_SIDED||||||Jonckheere-Terpstra|||Effects of liver dysfunction on PK parameter values were evaluated with SPSS 22.0 for Windows (SPSS Inc., Chicago, IL), using the Jonckheere-Terpstra and Kendall's Tau test. Data were considered significantly different when p\<0.05.||||0.037
72594849|NCT01273155|144720857|OTHER|M26/belinostat|Kendall's Tau|0.127||||0.275|TWO_SIDED||||||Jonckheere-Terpstra|||Effects of liver dysfunction on PK parameter values were evaluated with SPSS 22.0 for Windows (SPSS Inc., Chicago, IL), using the Jonckheere-Terpstra and Kendall's Tau test. Data were considered significantly different when p\<0.05.||||0.275
72594850|NCT01273155|144720857|OTHER|M24/M26|Kendall's Tau|-0.308||||0.002|TWO_SIDED||||||Jonckheere-Terpstra|||Effects of liver dysfunction on PK parameter values were evaluated with SPSS 22.0 for Windows (SPSS Inc., Chicago, IL), using the Jonckheere-Terpstra and Kendall's Tau test. Data were considered significantly different when p\<0.05.||||0.002
72594851|NCT01273155|144720857|OTHER|M26/M21|Kendall's Tau|-0.159||||0.095|TWO_SIDED||||||Jonckheere-Terpstra|||Effects of liver dysfunction on PK parameter values were evaluated with SPSS 22.0 for Windows (SPSS Inc., Chicago, IL), using the Jonckheere-Terpstra and Kendall's Tau test. Data were considered significantly different when p\<0.05.||||0.095
72594852|NCT01273155|144720858|OTHER|Belinostat glucuronide/belinostat|Kendall's Tau|-0.055||||0.568|TWO_SIDED||||||Jonckheere-Terpstra|||Effects of liver dysfunction on PK parameter values were evaluated with SPSS 22.0 for Windows (SPSS Inc., Chicago, IL), using the Jonckheere-Terpstra and Kendall's Tau test. Data were considered significantly different when p\<0.05.||||0.568
72594853|NCT01273155|144720858|OTHER|Methyl belinostat/belinostat|Kendall's Tau|0.38|||<|0.001|TWO_SIDED||||||Jonckheere-Terpstra|||Effects of liver dysfunction on PK parameter values were evaluated with SPSS 22.0 for Windows (SPSS Inc., Chicago, IL), using the Jonckheere-Terpstra and Kendall's Tau test. Data were considered significantly different when p\<0.05.||||<0.001
72594854|NCT01273155|144720858|OTHER|M21/belinostat|Kendall's Tau|0.315||||0.001|TWO_SIDED||||||Jonckheere-Terpstra|||Effects of liver dysfunction on PK parameter values were evaluated with SPSS 22.0 for Windows (SPSS Inc., Chicago, IL), using the Jonckheere-Terpstra and Kendall's Tau test. Data were considered significantly different when p\<0.05.||||0.001
72594855|NCT01273155|144720858|OTHER|M24/belinostat|Kendall's Tau|-0.205||||0.037|TWO_SIDED||||||Jonckheere-Terpstra|||Effects of liver dysfunction on PK parameter values were evaluated with SPSS 22.0 for Windows (SPSS Inc., Chicago, IL), using the Jonckheere-Terpstra and Kendall's Tau test. Data were considered significantly different when p\<0.05.||||0.037
72594856|NCT01273155|144720858|OTHER|M26/belinostat|Kendall's Tau|0.218||||0.033|TWO_SIDED||||||Jonckheere-Terpstra|||Effects of liver dysfunction on PK parameter values were evaluated with SPSS 22.0 for Windows (SPSS Inc., Chicago, IL), using the Jonckheere-Terpstra and Kendall's Tau test. Data were considered significantly different when p\<0.05.||||0.033
72594857|NCT01273155|144720858|OTHER|M24/M26|Kendall's Tau|-0.309||||0.001|TWO_SIDED||||||Jonckheere-Terpstra|||Effects of liver dysfunction on PK parameter values were evaluated with SPSS 22.0 for Windows (SPSS Inc., Chicago, IL), using the Jonckheere-Terpstra and Kendall's Tau test. Data were considered significantly different when p\<0.05.||||0.001
72594858|NCT01273155|144720858|OTHER|M26/M21|Kendall's Tau|-0.205||||0.032|TWO_SIDED||||||Jonckheere-Terpstra|||Effects of liver dysfunction on PK parameter values were evaluated with SPSS 22.0 for Windows (SPSS Inc., Chicago, IL), using the Jonckheere-Terpstra and Kendall's Tau test. Data were considered significantly different when p\<0.05.||||0.032
72594859|NCT00336323|144720861|SUPERIORITY_OR_OTHER|||||||0.009||95.0|||||Least squares regression|Adjusted for baseline values||Comparison of central subfield thickness at the 3 week visit between the laser only treatment group to the 1.25 mg injection at baseline and at 6 weeks treatment group||||0.009
72594860|NCT00336323|144720861|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Least squares regression|Adjusted for baseline values||Comparison of central subfield thickness at the 3 week visit between the laser only treatment group to the 2.5mg injection at baseline and 6 weeks treatment group||||<0.001
72594861|NCT00336323|144720861|SUPERIORITY_OR_OTHER|||||||0.66||95.0||||Adjusted for baseline values|Least squares regression|||Comparison of the reduction in central subfield thickening in the 1.25mg injection at baseline and at 6 weeks treatment group with the 2.5mg injection at baseline and 6 weeks treatment group at the 3 week visit||||0.66
72594862|NCT00336323|144720861|SUPERIORITY_OR_OTHER|||||||0.49||95.0||||Adjusted for baseline values|Least squares regression|||Comparison of the reduction in central subfield thickening in the 1.25mg injection at baseline and at 6 weeks treatment group with the 2.5mg injection at baseline and 6 weeks treatment group at the 6 week visit||||0.49
72594863|NCT00336323|144720861|SUPERIORITY_OR_OTHER|||||||0.45||95.0||||Adjusted for baseline values|Least squares regression|||Comparison of the reduction in central subfield thickening in the 1.25mg injection at baseline and at 6 weeks treatment group with the 2.5mg injection at baseline and 6 weeks treatment group at the 9 week visit||||0.45
72594864|NCT00336323|144720861|SUPERIORITY_OR_OTHER|||||||0.9||95.0|||||Least squares regression|Adjusted for baseline values||Comparison of the reduction in central subfield thickening in the 1.25mg injection at baseline and at 6 weeks treatment group with the 2.5mg injection at baseline and 6 weeks treatment group at the 12 week visit||||0.90
72594865|NCT00336323|144720862|SUPERIORITY_OR_OTHER|||||||0.42||95.0|||||Least squares regression|Adjusted for baseline values||Comparison of improvement in visual acuity between the 1.25mg injection at baseline and at 6 weeks treatment group and the 2.5mg injection at baseline and 6 weeks treatment group at the 3 week visit||||0.42
72594866|NCT00336323|144720862|SUPERIORITY_OR_OTHER|||||||0.67||95.0|||||Least squares regression|Adjusted for baseline values||Comparison of improvement in visual acuity between the 1.25mg injection at baseline and at 6 weeks treatment group and the 2.5mg injection at baseline and 6 weeks treatment group at the 6 week visit||||0.67
72594867|NCT00336323|144720862|SUPERIORITY_OR_OTHER|||||||0.48||95.0|||||Least squares regression|Adjusted for baseline values||Comparison of improvement in visual acuity between the 1.25mg injection at baseline and at 6 weeks treatment group and the 2.5mg injection at baseline and 6 weeks treatment group at the 9 week visit||||0.48
72594868|NCT00336323|144720862|SUPERIORITY_OR_OTHER|||||||0.82||95.0|||||Least squares regression|||Comparison of improvement in visual acuity between the 1.25mg injection at baseline and at 6 weeks treatment group and the 2.5mg injection at baseline and 6 weeks treatment group at the 12 week visit||||0.82
72594869|NCT00336323|144720862|SUPERIORITY_OR_OTHER|||||||0.01||95.0|||||Least squares regression|Adjusted for baseline values||Comparison of improvement in visual acuity through the 12 week visit between the laser only treatment group and the 1.25mg injection at baseline and at 6 weeks treatment group||||0.01
72594870|NCT00336323|144720862|SUPERIORITY_OR_OTHER|||||||0.003||95.0|||||Least squares regression|Adjusted for baseline values||Comparison of improvement in visual acuity through the 12 week visit between the laser only treatment group and the 2.5mg injection at baseline and at 6 weeks treatment group||||0.003
72594871|NCT00336323|144720865|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Least squares regression|Adjusted for baseline values||Comparison of central subfield thickness (microns) change from baseline to the 3 week visit between eyes that had baseline central subfield thickness of \<400 microns compared to those that had baseline central subfield thickness of ≥400 microns. Eyes included all of those from the pooled Bevacizumab group.||||<0.0001
72594872|NCT00336323|144720866|SUPERIORITY_OR_OTHER|||||||0.31||95.0|||||Least squares regression|Adjusted for baseline score||Comparison of central subfield thickness (microns) change from baseline to the 3 week visit between eyes that had baseline visual acuity letter score that was \<65 letters compared to those that had baseline visual acuity letter score that was ≥65 letters. Eyes included all of those from the pooled Bevacizumab group.||||0.31
72594873|NCT00336323|144720867|SUPERIORITY_OR_OTHER|||||||0.44||95.0|||||Least squares regression|||Comparison of central subfield thickness (microns) change from baseline to the 3 week visit between those that were ≤66 years old compared to those that were \>66 years old at baseline. Eyes included all of those from the pooled Bevacizumab group.||||0.44
72594874|NCT00336323|144720868|SUPERIORITY_OR_OTHER|||||||0.55||95.0|||||Least squares regression|||Comparison of central subfield thickness (microns) change from baseline to the 3 week visit between females and males. Eyes included all of those from the pooled Bevacizumab group.||||0.55
72594875|NCT00336323|144720869|SUPERIORITY_OR_OTHER|||||||0.16||95.0|||||Least squares regression|Adjusted for baseline values||Comparison of central subfield thickness (microns) change from baseline to the 3 week visit between eyes that had no history of treatment for diabetic macular edema compared to those that had history or treatment for diabetic macular edema. Eyes included all of those from the pooled Bevacizumab group.||||0.16
72594876|NCT00336323|144720870|SUPERIORITY_OR_OTHER|||||||0.53||95.0|||||Least squares regression|||Comparison of central subfield thickness (microns) change from baseline to the 3 week visit between eyes that had baseline retinopathy severity that was \<severe nonproliferative diabetic retinopathy (NPDR) compared to those that had baseline retinopathy severity that was proliferative diabetic retinopathy or severe NPDR. Eyes included all of those from the pooled Bevacizumab group.||||0.53
72594877|NCT00336323|144720871|SUPERIORITY_OR_OTHER|||||||0.93||95.0|||||Least squares regression|Adjusted for baseline values||Comparison of central subfield thickness (microns) change from baseline to the 3 week visit between eyes that had baseline clinical diabetic macular edema characterized as typical/predominantly focal, neither predominantly focal or diffuse, or typical/predominantly diffuse. Eyes included all of those from the pooled Bevacizumab group.||||0.93
72594878|NCT00336323|144720872|SUPERIORITY_OR_OTHER|||||||0.52||95.0|||||Least squares regression|Adjusted for baseline values||Comparison of central subfield thickness (microns) change from baseline to the 3 week visit between eyes that had baseline subretinal fluid that was definite/questionable compared to eyes that had no evidence of subretinal fluid at baseline. Eyes included all of those from the pooled Bevacizumab group.||||0.52
72594879|NCT00336323|144720873|SUPERIORITY_OR_OTHER|||||||0.22||95.0|||||Least squares regression|Adjusted for baseline values||Comparison of change in visual acuity letter score from baseline to the 3 week visit between eyes that had baseline central subfield thickness of \<400 microns compared to eyes that had baseline central subfield thickness of ≥400 microns. Eyes included all of those from the pooled Bevacizumab group.||||0.22
72594880|NCT00336323|144720874|SUPERIORITY_OR_OTHER|||||||0.006||95.0|||||Least squares regression|Adjusted for baseline values||Comparison of change in visual acuity letter score from baseline to the 3 week visit between eyes that had a baseline visual acuity letter score of \<65 letters compared to eyes that had baseline visual acuity letter score of ≥65 letters. Eyes included all of those from the pooled Bevacizumab group.||||0.006
72594881|NCT00336323|144720875|SUPERIORITY_OR_OTHER|||||||0.23||95.0|||||Least squares regression|||Comparison of change in visual acuity letter score from baseline to the 3 week visit between eyes that were ≤66 years old at baseline compared to eyes that were \>66 years old at baseline. Eyes included all of those from the pooled Bevacizumab group.||||0.23
72594882|NCT00336323|144720876|SUPERIORITY_OR_OTHER|||||||0.37||95.0|||||Least squares regression|||Comparison of change in visual acuity letter score from baseline to the 3 week visit between females and males. Eyes included all of those from the pooled Bevacizumab group.||||0.37
72594883|NCT00336323|144720877|SUPERIORITY_OR_OTHER|||||||0.04||95.0|||||Least squares regression|||Comparison of change in visual acuity letter score from baseline to the 3 week visit between eyes that did not have a prior history of treatment for diabetic macular edema compared to eyes that did have a prior history of treatment for diabetic macular edema. Eyes included all of those from the pooled Bevacizumab group.||||0.04
72594884|NCT00336323|144720878|SUPERIORITY_OR_OTHER|||||||0.38||95.0|||||Least squares regression|||Comparison of change in visual acuity letter score from baseline to the 3 week visit between eyes that had a baseline retinopathy severity of \<severe nonproliferative diabetic retinopathy (NPDR) compared to eyes that had baseline retinopathy severity of proliferative diabetic retinopathy or severe NPDR. Eyes included all of those from the pooled Bevacizumab group.||||0.38
72594885|NCT00336323|144720879|SUPERIORITY_OR_OTHER|||||||0.45||95.0|||||Least squares regression|||Comparison of change in visual acuity letter score from baseline to the 3 week visit between eyes that had a baseline clinical diabetic macular edema (DME) characterization of typical/predominantly focal compared to neither predominantly focal or diffuse characterization at baseline and compared to typical/predominantly diffuse characterization at baseline. Eyes included all of those from the pooled Bevacizumab group.||||0.45
72594886|NCT00336323|144720880|SUPERIORITY_OR_OTHER|||||||0.06||95.0|||||Least squares regression|||Comparison of change in visual acuity letter score from baseline to the 3 week visit between eyes that had a baseline subretinal fluid presence that was definite/questionable compared to eyes that there was no evidence of subretinal fluid at baseline. Eyes included all of those from the pooled Bevacizumab group.||||0.06
72594887|NCT01438814|144720893|NON_INFERIORITY_OR_EQUIVALENCE|One-sided test relative to 0.35|Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.06|<|0.0001|TWO_SIDED|95.0|-0.13|0.12|||ANCOVA|||||0.12|-0.13|<0.0001
72594888|NCT01438814|144720893|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.06||0.8924||95.0|-0.13|0.12|||ANCOVA|||||0.12|-0.13|0.8924
72594889|NCT01438814|144720894|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.96||||0.8201||95.0|0.672|1.37|||Regression, Logistic|Model includes treatment and continuous baseline HbA1c||||1.370|0.672|0.8201
72594890|NCT01438814|144720895|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.022||||0.9397|TWO_SIDED|95.0|0.582|1.796|||Regression, Logistic|Model includes treatment and baseline HbA1c.||||1.796|0.582|0.9397
72594891|NCT01438814|144720896|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.0|STANDARD_ERROR_OF_MEAN|2.1||0.3352||95.0|-2.1|6.1|||ANCOVA|||||6.1|-2.1|0.3352
72594892|NCT01438814|144720897|SUPERIORITY_OR_OTHER|||||||0.0308|||||||Fisher Exact|Fishers exact p-value presented due to small cell counts||||||0.0308
72594893|NCT01438814|144720898|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.5|STANDARD_ERROR_OF_MEAN|0.3||0.0545||95.0|0.0|1.0|||ANCOVA|||||1.0|-0.0|0.0545
72594894|NCT01438814|144720899|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.997||||0.9886||95.0|0.689|1.445|||Regression, Logistic|||||1.445|0.689|0.9886
72594895|NCT01438814|144720900|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.797||||0.2108||95.0|0.558|1.137|||Regression, Logistic|||||1.137|0.558|0.2108
72594896|NCT01438814|144720901|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.999||||0.9972||95.0|0.712|1.402|||Regression, Logistic|||||1.402|0.712|0.9972
72594897|NCT01438814|144720902|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.832||||0.2816||95.0|0.594|1.163|||Regression, Logistic|||||1.163|0.594|0.2816
72594898|NCT01438814|144720903|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.62|STANDARD_ERROR_OF_MEAN|0.19||0.0011||95.0|0.25|0.98|||ANCOVA|||||0.98|0.25|0.0011
72594899|NCT01438814|144720904|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.951||||0.7682||95.0|0.681|1.328|||Regression, Logistic|||||1.328|0.681|0.7682
72594900|NCT00337779|144720922|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.0732|STANDARD_ERROR_OF_MEAN|0.1013||0.4859|TWO_SIDED|95.0|0.8799|1.309|||Regression, Poisson||980 subjects randomized into two arms provide approximately 90% power to detect significant difference between groups of 30% or more in rate of confirmed relapses.|||1.3090|0.8799|0.4859
72594901|NCT01162122|144720934|NON_INFERIORITY_OR_EQUIVALENCE|The 95% CIs of GMT ratios for the pairwise lot-to-lot group comparisons should fall within the equivalence range of 0.67 to 1.5.|GMT ratio (H1N1 strain)|1.12|||||TWO_SIDED|95.0|1.0|1.24||||||||1.24|1|
72594902|NCT01162122|144720934|NON_INFERIORITY_OR_EQUIVALENCE|The 95% CIs of GMT ratios for the pairwise lot-to-lot group comparisons should fall within the equivalence range of 0.67 to 1.5.|GMT ratio (H1N1 strain)|1.05|||||TWO_SIDED|95.0|0.95|1.17||||||||1.17|0.95|
72594903|NCT01162122|144720934|NON_INFERIORITY_OR_EQUIVALENCE|The 95% CIs of GMT ratios for the pairwise lot-to-lot group comparisons should fall within the equivalence range of 0.67 to 1.5.|GMT ratio (H1N1 strain)|0.94|||||TWO_SIDED|95.0|0.85|1.05||||||||1.05|0.85|
72594904|NCT01162122|144720934|NON_INFERIORITY_OR_EQUIVALENCE|The 95% CIs of GMT ratios for the pairwise lot-to-lot group comparisons should fall within the equivalence range of 0.67 to 1.5.|GMT ratio (H3N2 strain)|1.01|||||TWO_SIDED|95.0|0.92|1.11||||||||1.11|0.92|
72594905|NCT01162122|144720934|NON_INFERIORITY_OR_EQUIVALENCE|The 95% CIs of GMT ratios for the pairwise lot-to-lot group comparisons should fall within the equivalence range of 0.67 to 1.5.|GMT ratio (H3N2 strain)|0.99|||||TWO_SIDED|95.0|0.9|1.08||||||||1.08|0.9|
72594906|NCT01162122|144720934|NON_INFERIORITY_OR_EQUIVALENCE|The 95% CIs of GMT ratios for the pairwise lot-to-lot group comparisons should fall within the equivalence range of 0.67 to 1.5.|GMT ratio (H3N2 strain)|0.98|||||TWO_SIDED|95.0|0.89|1.07||||||||1.07|0.89|
72594907|NCT01162122|144720934|NON_INFERIORITY_OR_EQUIVALENCE|The 95% CIs of GMT ratios for the pairwise lot-to-lot group comparisons should fall within the equivalence range of 0.67 to 1.5.|GMT ratio (B strain)|1.0|||||TWO_SIDED|95.0|0.91|1.1||||||||1.1|0.91|
72594908|NCT01162122|144720934|NON_INFERIORITY_OR_EQUIVALENCE|The 95% CIs of GMT ratios for the pairwise lot-to-lot group comparisons should fall within the equivalence range of 0.67 to 1.5.|GMT ratio (B strain)|0.96|||||TWO_SIDED|95.0|0.87|1.05||||||||1.05|0.87|
72594909|NCT01162122|144720934|NON_INFERIORITY_OR_EQUIVALENCE|The 95% CIs of GMT ratios for the pairwise lot-to-lot group comparisons should fall within the equivalence range of 0.67 to 1.5.|GMT ratio (B strain)|0.96|||||TWO_SIDED|95.0|0.87|1.05||||||||1.05|0.87|
72594910|NCT01162122|144720935|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of the 95% CI for the day 22 vaccine group GMT ratios for all 3 homologous strains was \>0.67.|GMT ratio (H1N1 strain)|1.4|||||TWO_SIDED|95.0|1.32|1.49||||||||1.49|1.32|
72594911|NCT01162122|144720935|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of the 95% CI for the day 22 vaccine group GMT ratios for all 3 homologous strains was \>0.67.|GMT ratio (H3N2 strain)|1.61|||||TWO_SIDED|95.0|1.52|1.7||||||||1.7|1.52|
72594912|NCT01162122|144720935|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of the 95% CI for the day 22 vaccine group GMT ratios for all 3 homologous strains was \>0.67.|GMT ratio (B strain)|1.15|||||TWO_SIDED|95.0|1.08|1.21||||||||1.21|1.08|
72594913|NCT01162122|144720936|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of the 95% CI for the day 22 differences in seroconversion rates for all 3 homologous strains was ≥-10%.|Group difference (H1N1 strain)|9.2|||||TWO_SIDED|95.0|7.1|11.3||||||||11.3|7.1|
72594914|NCT01162122|144720936|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of the 95% CI for the day 22 differences in seroconversion rates for all 3 homologous strains was ≥-10%.|Group difference (H3N2 strain)|12.7|||||TWO_SIDED|95.0|10.5|14.9||||||||14.9|10.5|
72594915|NCT01162122|144720936|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of the 95% CI for the day 22 differences in seroconversion rates for all 3 homologous strains was ≥-10%.|Group difference (B strain)|5.2|||||TWO_SIDED|95.0|3.0|7.4||||||||7.4|3.0|
72594916|NCT01162122|144720937|SUPERIORITY_OR_OTHER||GMT ratio (H1N1 strain)|1.37|||||TWO_SIDED|95.0|1.29|1.46||||||Superiority was established if the lower bound of the 95% CI for the day 22 vaccine group GMT ratios for at least 2 homologous strains was \>1.5.||1.46|1.29|
72594917|NCT01162122|144720937|SUPERIORITY_OR_OTHER||GMT ratio (H3N2 strain)|1.6|||||TWO_SIDED|95.0|1.51|1.68||||||Superiority was established if the lower bound of the 95% CI for the day 22 vaccine group GMT ratios for at least 2 homologous strains was \>1.5.||1.68|1.51|
72594918|NCT01162122|144720937|SUPERIORITY_OR_OTHER||GMT ratio (B strain)|1.14|||||TWO_SIDED|95.0|1.08|1.2||||||Superiority was established if the lower bound of the 95% CI for the day 22 vaccine group GMT ratios for at least 2 homologous strains was \>1.5.||1.2|1.08|
72594919|NCT01162122|144720938|SUPERIORITY_OR_OTHER||Group difference (H1N1 strain)|8.9|||||TWO_SIDED|95.0|6.9|10.9||||||Superiority was established if the lower bound of the 95% CI for the day 22 differences in seroconversion rates for at least 2 homologous strains was \>10%.||10.9|6.9|
72594920|NCT01162122|144720938|SUPERIORITY_OR_OTHER||Group difference (H3N2 strain)|12.7|||||TWO_SIDED|95.0|10.6|14.8||||||Superiority was established if the lower bound of the 95% CI for the day 22 differences in seroconversion rates for at least 2 homologous strains was \>10%.||14.8|10.6|
72594921|NCT01162122|144720938|SUPERIORITY_OR_OTHER||Group difference (B strain)|5.1|||||TWO_SIDED|95.0|2.9|7.2||||||Superiority was established if the lower bound of the 95% CI for the day 22 differences in seroconversion rates for at least 2 homologous strains was \>10%.||7.2|2.9|
72594922|NCT01162122|144720942|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of the 95% CI for the day 22 vaccine group GMT ratios for all 3 homologous strains was \>0.67.|GMT ratio (H1N1 strain)|1.38|||||TWO_SIDED|95.0|1.25|1.52||||||||1.52|1.25|
72415064|NCT04118348|144340107|SUPERIORITY||Odds Ratio (OR)|1.48||||0.021|TWO_SIDED|95.0|1.06|2.06|||Regression, Logistic||BPA-only is the numerator|HMT was set as the reference group.||2.06|1.06|.021
72415065|NCT04118348|144340107|SUPERIORITY||Odds Ratio (OR)|1.27||||0.107|TWO_SIDED|95.0|0.95|1.71|||Regression, Logistic||BPA+HMT is the numerator|BPA was set as the reference group.||1.71|0.95|.107
72415066|NCT04420221|144340191|SUPERIORITY||Vaccine Efficacy (VE)|-74.76||||0.8042||92.5|-680.61|36.62|||Log Rank|One-sided Group Sequential Design with non-binding beta, yielding two CIs based on cumulative alpha (92.5%) and beta (80.5%) spending|Vaccine Efficacy (VE) is defined as 1 minus the hazard ratio times 100.|||36.62|-680.61|0.8042
72415067|NCT04420221|144340192|OTHER||Vaccine Efficacy (VE)|-38.09|||||TWO_SIDED|95.0|-245.77|40.86|||||Vaccine Efficacy (VE) is defined as 1 minus the hazard ratio times 100.|||40.86|-245.77|
72415068|NCT04420221|144340193|OTHER||Vaccine Efficacy (VE)|-75.52|||||TWO_SIDED|95.0|-295.41|17.46|||||Vaccine Efficacy (VE) is defined as 1 minus the hazard ratio times 100.|||17.46|-295.41|
72415069|NCT00511004|144340194|SUPERIORITY_OR_OTHER||||||<|0.2|TWO_SIDED|||||Adjusted for multiple comparisons|Fisher Exact|||||||<0.2
72415070|NCT00511004|144340195|SUPERIORITY_OR_OTHER|||||||0.9|TWO_SIDED||||||Fisher Exact|||||||0.9
72415071|NCT02085408|144340219|SUPERIORITY||Hazard Ratio (HR)|1.1|||||TWO_SIDED|95.0|0.94|1.3|||Regression, Cox||Hazard ratio : clofarabine/(daunorubicin \& cytarabine)|||1.30|0.94|
72415072|NCT02085408|144340220|SUPERIORITY|||||||0.94|||||||Fisher Exact|||||||0.94
72415073|NCT00688636|144340270|SUPERIORITY_OR_OTHER|||||||0.0005|||||||Fisher Exact|||||||.0005
72594923|NCT01162122|144720942|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of the 95% CI for the day 22 vaccine group GMT ratios for all 3 homologous strains was \>0.67.|GMT ratio (H3N2 strain)|1.57|||||TWO_SIDED|95.0|1.44|1.72||||||||1.72|1.44|
72594924|NCT01162122|144720942|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of the 95% CI for the day 22 vaccine group GMT ratios for all 3 homologous strains was \>0.67.|GMT ratio (B strain)|1.12|||||TWO_SIDED|95.0|1.03|1.21||||||||1.21|1.03|
72594925|NCT01162122|144720943|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of the 95% CI for the day 22 differences in seroconversion rates for all 3 homologous strains was ≥-10%|Group difference (H1N1 strain)|11.1|||||TWO_SIDED|95.0|7.5|14.6||||||||14.6|7.5|
72594926|NCT01162122|144720943|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of the 95% CI for the day 22 differences in seroconversion rates for all 3 homologous strains was ≥-10%|Group difference (H3N2 strain)|13.5|||||TWO_SIDED|95.0|9.8|17.2||||||||17.2|9.8|
72594927|NCT01162122|144720943|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of the 95% CI for the day 22 differences in seroconversion rates for all 3 homologous strains was ≥-10%|Group difference (B strain)|5.0|||||TWO_SIDED|95.0|1.4|8.5||||||||8.5|1.4|
72594928|NCT01162122|144720944|SUPERIORITY_OR_OTHER||GMT ratio (H1N1 strain)|1.32|||||TWO_SIDED|95.0|1.2|1.45||||||Superiority was established if the lower bound of the 95% CI for the day 22 vaccine group GMT ratios for at least 2 homologous strains was \>1.5.||1.45|1.2|
72594929|NCT01162122|144720944|SUPERIORITY_OR_OTHER||GMT ratio (H3N2 strain)|1.54|||||TWO_SIDED|95.0|1.42|1.68||||||Superiority was established if the lower bound of the 95% CI for the day 22 vaccine group GMT ratios for at least 2 homologous strains was \>1.5.||1.68|1.42|
72594930|NCT01162122|144720944|SUPERIORITY_OR_OTHER||GMT ratio (B strain)|1.11|||||TWO_SIDED|95.0|1.03|1.21||||||Superiority was established if the lower bound of the 95% CI for the day 22 vaccine group GMT ratios for at least 2 homologous strains was \>1.5.||1.21|1.03|
72594931|NCT01162122|144720948|SUPERIORITY_OR_OTHER||Group difference (H1N1 strain)|9.9|||||TWO_SIDED|95.0|6.4|13.3||||||Superiority was established if the lower bound of the 95% CI for the day 22 differences in seroconversion rates for at least 2 homologous strains was \>10%.||13.3|6.4|
72415074|NCT01392560|144340304|SUPERIORITY_OR_OTHER||Mean change from baseline|-19.6|STANDARD_ERROR_OF_MEAN|5.6||0.0011|||||||Paired t-test||Estimated value = mean of end of treatment - baseline|Test of the difference between baseline and end of treatment under euglycaemia condition for all patients||||0.0011
72594932|NCT01162122|144720948|SUPERIORITY_OR_OTHER||Group difference (H3N2 strain)|13.0|||||TWO_SIDED|95.0|9.5|16.6||||||Superiority was established if the lower bound of the 95% CI for the day 22 differences in seroconversion rates for at least 2 homologous strains was \>10%.||16.6|9.5|
72594933|NCT01162122|144720948|SUPERIORITY_OR_OTHER||Group difference (B strain)|4.9|||||TWO_SIDED|95.0|1.5|8.3||||||Superiority was established if the lower bound of the 95% CI for the day 22 differences in seroconversion rates for at least 2 homologous strains was \>10%.||8.3|1.5|
72594934|NCT01162122|144720949|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of the 95% CI for the day 22 vaccine group GMT ratios for all 3 heterologous strains was \>0.67.|GMT Ratio (H3N2/Brisbane-overall)|1.45|||||TWO_SIDED|95.0|1.29|1.63||||||||1.63|1.29|
72594935|NCT01162122|144720949|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of the 95% CI for the day 22 vaccine group GMT ratios for all 3 heterologous strains was \>0.67.|GMT Ratio (H3N2/Wisconsin-overall)|1.36|||||TWO_SIDED|95.0|1.23|1.5||||||||1.5|1.23|
72594936|NCT01162122|144720949|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of the 95% CI for the day 22 vaccine group GMT ratios for all 3 heterologous strains was ≥0.67.|GMT Ratio (B strain-overall)|1.09|||||TWO_SIDED|95.0|0.98|1.21||||||||1.21|0.98|
72594937|NCT01162122|144720949|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of the 95% CI for the day 22 vaccine group GMT ratios for all 3 heterologous strains was \>0.67.|GMT Ratio(H3N2/Brisbane-high risk group)|1.35||||||95.0|1.13|1.61||||||||1.61|1.13|
72594938|NCT01162122|144720949|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of the 95% CI for the day 22 vaccine group GMT ratios for all 3 heterologous strains was \>0.67.|GMT Ratio(H3N2/Wisconsin-high risk group|1.29|||||TWO_SIDED|95.0|1.1|1.5||||||||1.5|1.1|
72594939|NCT01162122|144720949|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of the 95% CI for the day 22 vaccine group GMT ratios for all 3 heterologous strains was \>0.67.|GMT Ratio (B strain-high risk group)|1.11|||||TWO_SIDED|95.0|0.95|1.3||||||||1.3|0.95|
72415075|NCT01392560|144340304|SUPERIORITY_OR_OTHER||Mean change from baseline|-30.8|STANDARD_ERROR_OF_MEAN|6.2|<|0.0001|||||||Paired t-test||Estimated value = mean of end of treatment - baseline|Test the difference between baseline and end of treatment under hyperglycaemia condition for all patients||||<0.0001
72594940|NCT01162122|144720950|SUPERIORITY_OR_OTHER||GMT ratio (H3N2/Brisbane-overall)|1.49|||||TWO_SIDED|95.0|1.33|1.67||||||Superiority was established if the lower bound of the 95% CI for the day 22 vaccine group GMT ratios for at least 2 heterologous strains was \>1.5.||1.67|1.33|
72594941|NCT01162122|144720950|SUPERIORITY_OR_OTHER||GMT ratio(H3N2/Wisconsin-overall)|1.38|||||TWO_SIDED|95.0|1.25|1.52||||||Superiority was established if the lower bound of the 95% CI for the day 22 vaccine group GMT ratios for at least 2 heterologous strains was \>1.5.||1.52|1.25|
72594942|NCT01162122|144720950|SUPERIORITY_OR_OTHER||GMT ratio (B strain-overall)|1.09|||||TWO_SIDED|95.0|0.99|1.21||||||Superiority was established if the lower bound of the 95% CI for the day 22 vaccine group GMT ratios for at least 2 heterologous strains was \>1.5.||1.21|0.99|
72594943|NCT01162122|144720950|SUPERIORITY_OR_OTHER||GMT ratio (H3N2/Brisbane-high risk)|1.36|||||TWO_SIDED|95.0|1.15|1.61||||||Superiority was established if the lower bound of the 95% CI for the day 22 vaccine group GMT ratios for at least 2 heterologous strains was \>1.5.||1.61|1.15|
72594944|NCT01162122|144720950|SUPERIORITY_OR_OTHER||GMT ratio(H3N2/Wisconsin-high risk)|1.28|||||TWO_SIDED|95.0|1.1|1.48||||||Superiority was established if the lower bound of the 95% CI for the day 22 vaccine group GMT ratios for at least 2 heterologous strains was \>1.5.||1.48|1.1|
72594945|NCT01162122|144720950|SUPERIORITY_OR_OTHER||GMT ratio (B strain-high risk)|1.13|||||TWO_SIDED|95.0|0.97|1.31||||||Superiority was established if the lower bound of the 95% CI for the day 22 vaccine group GMT ratios for at least 2 heterologous strains was \>1.5.||1.31|0.97|
72594946|NCT01162122|144720951|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of the 95% CI for the day 22 differences in seroconversion rates for all 3 heterologous strains was ≥-10%.|Group difference (H3N2/Brisbane-overall)|11.3|||||TWO_SIDED|95.0|6.7|15.9||||||||15.9|6.7|
72594947|NCT01162122|144720951|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of the 95% CI for the day 22 differences in seroconversion rates for all 3 heterologous strains was ≥-10%.|Group difference(H3N2/Wisconsin-overall)|11.9|||||TWO_SIDED|95.0|7.3|16.6||||||||16.6|7.3|
72594948|NCT01162122|144720951|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of the 95% CI for the day 22 differences in seroconversion rates for all 3 homologous strains was ≥-10%.|Slope|4.0|||||TWO_SIDED|95.0|-0.4|8.4||||||||8.4|-0.4|
72594949|NCT01162122|144720951|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of the 95% CI for the day 22 differences in seroconversion rates for all 3 heterologous strains was ≥-10%.|Group difference(H3N2/Brisbane-high risk|12.3|||||TWO_SIDED|95.0|4.8|19.9||||||||19.9|4.8|
72594950|NCT01162122|144720951|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of the 95% CI for the day 22 differences in seroconversion rates for all 3 homologous strains was ≥-10%.|Group difference(H3N2Wisconsin-high risk|12.6|||||TWO_SIDED|95.0|5.0|20.2||||||||20.2|5.0|
72594951|NCT01162122|144720951|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of the 95% CI for the day 22 differences in seroconversion rates for all 3 heterologous strains was ≥-10%.|Group difference (B strain-high risk)|4.8|||||TWO_SIDED|95.0|-2.1|11.8||||||||11.8|-2.1|
72415076|NCT01392560|144340304|SUPERIORITY_OR_OTHER||Change from baseline|-33.4|STANDARD_ERROR_OF_MEAN|6.2|<|0.0001|||||||Paired t-test||Estimated value = mean of end of treatment - baseline|Test of the difference between baseline and end of treatment under euglycaemia condition for hyperfilterers||||<0.0001
72594952|NCT01162122|144720952|SUPERIORITY_OR_OTHER||Group difference (H3N2/Brisbane-overall)|12.5|||||TWO_SIDED|95.0|8.1|16.9||||||Superiority was established if the lower bound of the 95% CI for the day 22 differences in seroconversion rates for at least 2 heterologous strains was \>10%.||16.9|8.1|
72594953|NCT01162122|144720952|SUPERIORITY_OR_OTHER||Group difference(H3N2/Wisconsin-overall)|12.6|||||TWO_SIDED|95.0|8.1|17.1||||||Superiority was established if the lower bound of the 95% CI for the day 22 differences in seroconversion rates for at least 2 heterologous strains was \>10%.||17.1|8.1|
72594954|NCT01162122|144720952|SUPERIORITY_OR_OTHER||Group difference (B strain-overall)|4.6|||||TWO_SIDED|95.0|0.4|8.8||||||Superiority was established if the lower bound of the 95% CI for the day 22 differences in seroconversion rates for at least 2 heterologous strains was \>10%.||8.8|0.4|
72594955|NCT01162122|144720952|SUPERIORITY_OR_OTHER||Group difference(H3N2/Brisbane-high risk|12.4|||||TWO_SIDED|95.0|5.2|19.6||||||Superiority was established if the lower bound of the 95% CI for the day 22 differences in seroconversion rates for at least 2 heterologous strains was \>10%.||19.6|5.2|
72594956|NCT01162122|144720952|SUPERIORITY_OR_OTHER||Group difference(H3N2/Wisconsin-highrisk|13.0|||||TWO_SIDED|95.0|5.8|20.3||||||Superiority was established if the lower bound of the 95% CI for the day 22 differences in seroconversion rates for at least 2 heterologous strains was \>10%.||20.3|5.8|
72594957|NCT01162122|144720952|SUPERIORITY_OR_OTHER||Group difference (B strain-high risk)|5.1|||||TWO_SIDED|95.0|-1.6|11.8||||||Superiority was established if the lower bound of the 95% CI for the day 22 differences in seroconversion rates for at least 2 heterologous strains was \>10%.||11.8|-1.6|
72594958|NCT03313310|144720972|OTHER|A one-sample non-parametric test for change between baseline and 8-month follow-up was conducted.||||||0.98||||||The a priori threshold for statistical significance was set at 0.10. This p-value was not adjusted for multiple comparisons.|Wilcoxon Signed Rank|||||||0.98
72594959|NCT03313310|144720972|OTHER|A one-sample non-parametric test for change between baseline and 3-month follow-up was conducted.||||||0.05||||||The a priori threshold for statistical significance was set at 0.10. This p-value was not adjusted for multiple comparisons.|Wilcoxon Signed Rank|||||||0.05
72594960|NCT03313310|144720973|OTHER|A one-sample non-parametric test for change between baseline and 8-month follow-up was conducted.||||||0.39||||||The a priori threshold for statistical significance was set at 0.10. This p-value was not adjusted for multiple comparisons.|Wilcoxon Signed Rank|||||||0.39
72594961|NCT03313310|144720973|OTHER|A one-sample non-parametric test for change between baseline and 3-month follow-up was conducted.||||||0.76||||||The a priori threshold for statistical significance was set at 0.10. This p-value was not adjusted for multiple comparisons.|Wilcoxon Signed Rank|||||||0.76
72594962|NCT03313310|144720974|OTHER|A one-sample non-parametric test for change between baseline and 8-month follow-up was conducted.|||||<|0.001||||||The a priori threshold for statistical significance was set at 0.10. This p-value was not adjusted for multiple comparisons.|Wilcoxon Signed Rank|||||||<0.001
72415077|NCT01392560|144340304|SUPERIORITY_OR_OTHER||Mean change from baseline|-44.5|STANDARD_ERROR_OF_MEAN|7.1|<|0.0001|||||||Paired t-test||Estimated value = mean of end of treatment - baseline|Test of the difference between baseline and end of treatment under hyperglycaemia condition for hyperfilterers||||<0.0001
72594963|NCT03313310|144720974|OTHER|A one-sample non-parametric test for change between baseline and 3-month follow-up was conducted.||||||0.02||||||The a priori threshold for statistical significance was set at 0.10. This p-value was not adjusted for multiple comparisons.|Wilcoxon Signed Rank|||||||0.02
72594964|NCT03313310|144720975|OTHER|A one-sample non-parametric test for change between baseline and 8-month follow-up was conducted.||||||0.51||||||The a priori threshold for statistical significance was set at 0.10. This p-value was not adjusted for multiple comparisons.|Wilcoxon Signed Rank|||||||0.51
72594965|NCT03313310|144720975|OTHER|A one-sample non-parametric test for change between baseline and 3-month follow-up was conducted.||||||0.17||||||The a priori threshold for statistical significance was set at 0.10. This p-value was not adjusted for multiple comparisons.|Wilcoxon Signed Rank|||||||0.17
72594966|NCT03313310|144720976|OTHER||||||||||||||||||A one-sample McNemar's test for change between baseline and 8-month follow-up was planned. The a priori threshold for statistical significance was set at 0.10. However, McNemar's test statistic could not be calculated due to small cell counts.|||
72594967|NCT03313310|144720976|OTHER||||||||||||||||||A one-sample McNemar's test for change between baseline and 3-month follow-up was planned. The a priori threshold for statistical significance was set at 0.10. However, McNemar's test statistic could not be calculated due to small cell counts.|||
72594968|NCT03313310|144720977|OTHER|A one-sample test for change between baseline and 8-month follow-up was conducted.||||||1||||||The a priori threshold for statistical significance was set at 0.10. This p-value was not adjusted for multiple comparisons.|McNemar|||||||1.00
72594969|NCT03313310|144720977|OTHER|A one-sample test for change between baseline and 3-month follow-up was conducted.||||||0.5||||||The a priori threshold for statistical significance was set at 0.10. This p-value was not adjusted for multiple comparisons.|McNemar|||||||0.50
72594970|NCT03313310|144720978|OTHER|A one-sample test for change between baseline and 8-month follow-up was conducted.||||||0.63||||||The a priori threshold for statistical significance was set at 0.10. This p-value was not adjusted for multiple comparisons.|McNemar|||||||0.63
72594971|NCT03313310|144720978|OTHER|A one-sample test for change between baseline and 3-month follow-up was conducted.||||||1||||||The a priori threshold for statistical significance was set at 0.10. This p-value was not adjusted for multiple comparisons.|McNemar|||||||1.00
72594972|NCT03313310|144720979|OTHER|A one-sample test for change between baseline and 8-month follow-up was conducted.||||||1||||||The a priori threshold for statistical significance was set at 0.10. This p-value was not adjusted for multiple comparisons.|McNemar|||||||1.00
72594973|NCT03313310|144720979|OTHER|A one-sample test for change between baseline and 3-month follow-up was conducted.||||||0.25||||||The a priori threshold for statistical significance was set at 0.10. This p-value was not adjusted for multiple comparisons.|McNemar|||||||0.25
72594974|NCT03313310|144720980|OTHER|A one-sample test for change between baseline and 8-month follow-up was conducted.||||||1||||||The a priori threshold for statistical significance was set at 0.10. This p-value was not adjusted for multiple comparisons.|McNemar|||||||1.00
72594975|NCT03313310|144720980|OTHER|A one-sample test for change between baseline and 3-month follow-up was conducted.||||||1||||||The a priori threshold for statistical significance was set at 0.10. This p-value was not adjusted for multiple comparisons.|McNemar|||||||1.00
72594976|NCT03313310|144720981|OTHER||||||||||||||||||A one-sample McNemar's test for change between baseline and 8-month follow-up was planned. The a priori threshold for statistical significance was set at 0.10. However, McNemar's test statistic could not be calculated due to small cell counts.|||
72594977|NCT03313310|144720981|OTHER||||||||||||||||||A one-sample McNemar's test for change between baseline and 3-month follow-up was planned. The a priori threshold for statistical significance was set at 0.10. However, McNemar's test statistic could not be calculated due to small cell counts.|||
72594978|NCT03313310|144720983|OTHER|A one-sample test for change between baseline and 8-month follow-up was conducted.||||||1||||||The a priori threshold for statistical significance was set at 0.10. This p-value was not adjusted for multiple comparisons.|McNemar|||||||1.00
72594979|NCT03313310|144720983|OTHER|A one-sample test for change between baseline and 3-month follow-up was conducted.||||||1||||||The a priori threshold for statistical significance was set at 0.10. This p-value was not adjusted for multiple comparisons.|McNemar|||||||1.00
72594980|NCT03313310|144720984|OTHER|A one-sample test for change between baseline and 8-month follow-up was conducted.||||||1||||||The a priori threshold for statistical significance was set at 0.10. This p-value was not adjusted for multiple comparisons.|McNemar|||||||1.00
72594981|NCT03313310|144720984|OTHER|A one-sample test for change between baseline and 3-month follow-up was conducted.||||||0.75||||||The a priori threshold for statistical significance was set at 0.10. This p-value was not adjusted for multiple comparisons.|McNemar|||||||0.75
72594982|NCT03313310|144720985|OTHER|A one-sample test for change between baseline and 8-month follow-up was conducted.||||||0.55||||||The a priori threshold for statistical significance was set at 0.10. This p-value was not adjusted for multiple comparisons.|McNemar|||||||0.55
72594983|NCT03313310|144720985|OTHER|A one-sample test for change between baseline and 3-month follow-up was conducted.||||||1||||||The a priori threshold for statistical significance was set at 0.10. This p-value was not adjusted for multiple comparisons.|McNemar|||||||1.00
72594984|NCT03313310|144720986|OTHER|A one-sample test for change between baseline and 8-month follow-up was conducted.||||||0.45||||||The a priori threshold for statistical significance was set at 0.10. This p-value was not adjusted for multiple comparisons.|McNemar|||||||0.45
72594985|NCT03313310|144720986|OTHER|A one-sample test for change between baseline and 3-month follow-up was conducted.||||||0.07||||||The a priori threshold for statistical significance was set at 0.10. This p-value was not adjusted for multiple comparisons.|McNemar|||||||0.07
72415078|NCT01392560|144340304|SUPERIORITY_OR_OTHER||Mean change from baseline|9.0|STANDARD_ERROR_OF_MEAN|5.9||0.1524|||||||Paired t-test||Estimated value = mean of end of treatment - baseline|Test of the difference between baseline and end of treatment under euglycaemia condition for non-hyperfilterers||||0.1524
72415079|NCT01392560|144340304|SUPERIORITY_OR_OTHER||Mean change from baseline|-2.4|STANDARD_ERROR_OF_MEAN|7.7||0.7585|||||||Paired t-test||Estimated value = mean of end of treatment - baseline|Test of the difference between baseline and end of treatment under hyperglycaemia condition for non-filterers||||0.7585
72594986|NCT01217385|144720987|EQUIVALENCE|under the NULL, it is assume that there is no difference between a 40% decrease in TOI, and a less than 40% decrease or an increase in TOI in their ability to predict pCR+|Odds Ratio (OR)|4.667||||0.059|TWO_SIDED|95.0|0.95|23.04||5% alpha threshold for significance.|Regression, Logistic|||"This analysis will look at the ability of the % change in DOSI measured tumor Optical Index (TOI) from baseline to mid-therapy to predict pathologic response using logistic regression.~Pathologic response (dichotomized into responders and non-responders) will be used as the reference standard and %change in TOI ratio (dichotomized at -40%) will be used to estimate pCR (+/-)= alpha + beta1(%change TOI)"||23.04|0.95|0.059
72415080|NCT04773587|144340344|SUPERIORITY||Odds Ratio (OR)|2.96|||<|0.0001|TWO_SIDED|95.0|1.881|4.647|||Cochran-Mantel-Haenszel|Stratified by pooled study site and vIGA-AD randomization strata with multiple imputation of missing observations|Stratified by pooled study site and vIGA-AD randomization strata with multiple imputation of missing observations|Difference in vIGA-AD Success at Week 4||4.647|1.881|<0.0001
72594987|NCT01217385|144720988|EQUIVALENCE|test for the equivalence of %change in TOI ratio (dichotomized at \<=-40%), between PR+ and PR- groups, with interaction|Slope|0.4463|STANDARD_ERROR_OF_MEAN|1.953||0.8193|TWO_SIDED|||||significance at alpha=0.05|Regression, Logistic|p-value represents the interaction between %TOI (dichotomized at \<=-40%), and PR status|Multivariate logistic regression model using % change in TOI ratio (T/N) (baseline to mid-therapy) dichotomized at -40%, PR status, and the corresponding interaction.|The Null is that the odd ratio is the same in both the PR+ and PR- subjects fro the model including %change in TOI form baseline to mid-therapy (dichotomized at \<=-40%), PR status (+/-) and the interaction between them.||||0.8193
72594988|NCT01217385|144720989|OTHER||Odds Ratio (OR)|16.5||||0.043|TWO_SIDED|95.0|1.09|250.15|||Regression, Logistic|||||250.15|1.09|0.043
72594989|NCT01217385|144720989|OTHER||Odds Ratio (OR)|2.86||||0.406|TWO_SIDED|95.0|0.24|33.9|||Regression, Logistic|||||33.90|0.24|0.406
72415081|NCT04773587|144340345|SUPERIORITY||Odds Ratio (OR)|2.67|||<|0.0001|TWO_SIDED|95.0|1.64|4.359|||Cochran-Mantel-Haenszel|Stratified by pooled study site with multiple imputation of missing observations|Stratified by pooled study site with multiple imputation of missing observations|Difference in vIGA-AD Success at Week 4||4.359|1.640|<0.0001
72594990|NCT01592292|144721006|SUPERIORITY_OR_OTHER|||||||0.3037||||||Change in DAS28 at Month 6 was performed using analysis of covariance (ANCOVA) model with baseline DAS28 score and rheumatoid factor (RF) status as covariate values.|ANCOVA|||||||0.3037
72415082|NCT04773587|144340346|SUPERIORITY||Odds Ratio (OR)|1.98||||0.0089|TWO_SIDED|95.0|1.186|3.319|||Cochran-Mantel-Haenszel|Stratified by pooled study site and vIGA-AD randomization strata with multiple imputation of missing observations|Stratified by pooled study site and vIGA-AD randomization strata with multiple imputation of missing observations|WI-NRS Success at Week 4||3.319|1.186|0.0089
72415083|NCT04773587|144340347|SUPERIORITY||Odds Ratio (OR)|2.81||||0.0016|TWO_SIDED|95.0|1.45|5.457|||Cochran-Mantel-Haenszel|Stratified by pooled study site and vIGA-AD randomization strata with multiple imputation of missing observations|Stratified by pooled study site and vIGA-AD randomization strata with multiple imputation of missing observations|WI-NRS Success at Week 2||5.457|1.450|0.0016
72594991|NCT01592292|144721007|SUPERIORITY_OR_OTHER|||||||0.0951||||||Change in DAS28 at Month 6 was performed using ANCOVA model with baseline DAS28 score and rheumatoid factor status as covariate values.|ANCOVA|||||||0.0951
72594992|NCT01592292|144721008|SUPERIORITY_OR_OTHER|||||||0.239||||||Change in DAS28 at Month 12 was performed using ANCOVA model with baseline DAS28 score and rheumatoid factor status as covariate values.|ANCOVA|||||||0.2390
72594993|NCT01592292|144721009|SUPERIORITY_OR_OTHER|||||||0.3212||||||Change in TJC at Month 6 was performed using ANCOVA model with baseline TJC and baseline rheumatoid factor status as covariate values.|ANCOVA|||||||0.3212
72594994|NCT01592292|144721009|SUPERIORITY_OR_OTHER|||||||0.7097||||||Change in TJC at Month 12 was performed using ANCOVA model with baseline TJC and baseline rheumatoid factor status as covariate values.|ANCOVA|||||||0.7097
72594995|NCT01592292|144721010|SUPERIORITY_OR_OTHER|||||||0.2444||||||Change in TJC at Month 6 was performed using ANCOVA with baseline TJC and baseline rheumatoid factor status as covariate values.|ANCOVA|||||||0.2444
72594996|NCT01592292|144721010|SUPERIORITY_OR_OTHER|||||||0.3903||||||Change in TJC at Month 12 was performed using ANCOVA model with baseline TJC and baseline rheumatoid factor status as covariate values.|ANCOVA|||||||0.3903
72594997|NCT01592292|144721011|SUPERIORITY_OR_OTHER|||||||0.5306||||||Change in SJC at Month 6 was performed using ANCOVA model with baseline SJC and baseline rheumatoid factor status as covariate values.|ANCOVA|||||||0.5306
72594998|NCT01592292|144721011|SUPERIORITY_OR_OTHER|||||||0.2542||||||Change in SJC at Month 12 was performed using ANCOVA model with baseline SJC and baseline rheumatoid factor status as covariate values.|ANCOVA|||||||0.2542
72594999|NCT01592292|144721012|SUPERIORITY_OR_OTHER|||||||0.2549||||||Change in SJC at Month 6 was performed using ANCOVA model with baseline SJC and baseline rheumatoid factor status as covariate values.|ANCOVA|||||||0.2549
72595000|NCT01592292|144721012|SUPERIORITY_OR_OTHER|||||||0.7644||||||Change in SJC at Month 12 was performed using ANCOVA model with baseline SJC and baseline rheumatoid factor status as covariate values.|ANCOVA|||||||0.7644
72595001|NCT01592292|144721013|SUPERIORITY_OR_OTHER|||||||0.8987||||||Change in ESR at Month 6 was performed using ANCOVA model with baseline ESR and rheumatoid factor status as covariate values.|ANCOVA|||||||0.8987
72595002|NCT01592292|144721013|SUPERIORITY_OR_OTHER|||||||0.5808||||||Change in ESR at Month 12 was performed using ANCOVA model with baseline ESR and rheumatoid factor status as covariate values.|ANCOVA|||||||0.5808
72595003|NCT01592292|144721014|SUPERIORITY_OR_OTHER|||||||0.2282||||||Change in ESR at Month 6 was performed using ANCOVA model with baseline ESR and baseline rheumatoid factor status as covariate values.|ANCOVA|||||||0.2282
72595004|NCT01592292|144721014|SUPERIORITY_OR_OTHER|||||||0.5849||||||Change in ESR at Month 12 was performed using ANCOVA model with baseline ESR and baseline rheumatoid factor status as covariate values.|ANCOVA|||||||0.5849
72595005|NCT01592292|144721015|SUPERIORITY_OR_OTHER|||||||0.49||||||Change in CRP at Month 6 was performed using ANCOVA model with baseline CRP and baseline rheumatoid factor status as covariate values.|ANCOVA|||||||0.4900
72595006|NCT01592292|144721015|SUPERIORITY_OR_OTHER|||||||0.1826||||||Change in CRP at Month 12 was performed using ANCOVA model with baseline CRP and baseline rheumatoid factor status as covariate values.|ANCOVA|||||||0.1826
72595007|NCT01592292|144721016|SUPERIORITY_OR_OTHER|||||||0.1894||||||Change in CRP at Month 6 was performed using ANCOVA model with baseline CRP and baseline rheumatoid factor status as covariate values.|ANCOVA|||||||0.1894
72595008|NCT01592292|144721016|SUPERIORITY_OR_OTHER|||||||0.1805||||||Change in CRP at Month 12 was performed using ANCOVA model with baseline CRP and baseline rheumatoid factor status as covariate values.|ANCOVA|||||||0.1805
72595009|NCT01592292|144721017|SUPERIORITY_OR_OTHER|||||||0.0568||||||Change in HAQ-DI at Month 6 was performed using ANCOVA model with baseline rheumatoid factor status as covariate value.|ANCOVA|||||||0.0568
72595010|NCT01592292|144721018|SUPERIORITY_OR_OTHER|||||||0.1167||||||Change in HAQ-DI at Month 6 was performed using ANCOVA model with baseline rheumatoid factor status as covariate value.|ANCOVA|||||||0.1167
72595011|NCT03660475|144721021|SUPERIORITY|||||||0.967|||||||t-test, 2 sided|||||||0.967
72595012|NCT03660475|144721022|SUPERIORITY|||||||0.836|||||||t-test, 2 sided|||||||0.836
72595013|NCT03660475|144721023|SUPERIORITY|||||||0.166|||||||t-test, 2 sided|||||||0.166
72595014|NCT03660475|144721024|SUPERIORITY|||||||0.638|||||||t-test, 2 sided|||||||0.638
72595015|NCT03660475|144721025|SUPERIORITY|||||||0.122|||||||t-test, 2 sided|||||||0.122
72595016|NCT03660475|144721026|SUPERIORITY|||||||0.2|||||||t-test, 2 sided|||||||0.200
72595017|NCT03660475|144721027|SUPERIORITY|||||||0.085|||||||t-test, 2 sided|||||||0.085
72595018|NCT03660475|144721029|SUPERIORITY|||||||0.903|||||||t-test, 2 sided|||||||0.903
72595019|NCT03660475|144721030|SUPERIORITY|||||||0.898|||||||t-test, 2 sided|||||||0.898
72595020|NCT03660475|144721031|SUPERIORITY|||||||0.221|||||||t-test, 2 sided|||||||0.221
72595021|NCT03660475|144721032|SUPERIORITY|||||||0.459|||||||t-test, 2 sided|||||||0.459
72415084|NCT04773587|144340348|SUPERIORITY||Odds Ratio (OR)|3.81||||0.0159|TWO_SIDED|95.0|1.161|12.511|||Cochran-Mantel-Haenszel|Stratified by pooled study site and vIGA-AD randomization strata with multiple imputation of missing observations|Stratified by pooled study site and vIGA-AD randomization strata with multiple imputation of missing observations|WI-NRS Success at Week 1||12.511|1.161|0.0159
72415085|NCT04773587|144340349|SUPERIORITY||Odds Ratio (OR)|3.17|||<|0.0001|TWO_SIDED|95.0|2.102|4.795|||Cochran-Mantel-Haenszel|Stratified by pooled study site and vIGA-AD randomization strata with multiple imputation of missing observations|Stratified by pooled study site and vIGA-AD randomization strata with multiple imputation of missing observations|EASI-75 at Week 4||4.795|2.102|<0.0001
72595022|NCT02327013|144721073|SUPERIORITY||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|1.8||0.9723|TWO_SIDED|95.0|-3.6|3.5|||weighed z-score|Equally weighed LS z-score, combining results from stagewise MMRM, was compared to standard normal distribution.||The mean difference between treatment groups was estimated based on LS means for the treatment-by-visit interaction in stagewise MMRM analyses. In each stage, the REML-based MMRM model included site ID (stage 1 only), visit, treatment (placebo, vortioxetine 10mg, vortioxetine 20mg), baseline (for the stage) AISRS total score, treatment-by-visit interaction, and baseline (stage) AISRS total score-by-visit interaction, with an unstructured covariance structure to model the within-patient errors.||3.5|-3.6|0.9723
72595023|NCT02327013|144721073|SUPERIORITY|The mean difference between treatment groups was estimated based on LS means for the treatment-by-visit interaction in stagewise MMRM analyses. In each stage, the REML-based MMRM model included site ID (stage 1 only), visit, treatment (placebo, vortioxetine 10mg, vortioxetine 20mg), baseline (for the stage) AISRS total score, treatment-by-visit interaction, and baseline (stage) AISRS total score-by-visit interaction, with an unstructured covariance structure to model the within-patient errors.|Mean Difference (Final Values)|1.0|STANDARD_DEVIATION|1.9||0.601|TWO_SIDED|95.0|-2.8|4.8|||weighed z-score|Equally weighed LS z-score, combining results from stagewise MMRM, was compared to standard normal distribution.||||4.8|-2.8|0.6010
72595024|NCT01642485|144721159|SUPERIORITY_OR_OTHER|||||||0.05|||||||t-test, 1 sided|||The effect of insulin, C-peptide and glucose on QTcF was investigated using linear mixed effect concentration-response models with the double difference of QTcF (difference to time matched placebo of the change from average baseline) as dependent variable and up to two of the variables change from time matched placebo in insulin, C-peptide and glucose as covariates.||||0.05
72595025|NCT01642485|144721160|SUPERIORITY_OR_OTHER|||||||0.05|||||||t-test, 1 sided|||The relevant confirmatory null hypotheses could all be rejected on the 5% level (one sided), i.e. a difference in QTcF between continental breakfast and placebo; between FDA breakfast and placebo could be ascertained.||||0.05
72595026|NCT01642485|144721160|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.9|||||TWO_SIDED|90.0|-10.4|-5.5||||||||-5.5|-10.4|
72595027|NCT01642485|144721160|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-6.8|||||TWO_SIDED|90.0|-9.3|-4.3||||||||-4.3|-9.3|
72595028|NCT00766467|144721164|SUPERIORITY_OR_OTHER|||||||0.3|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.3
72595029|NCT04007107|144721322|OTHER|Comparison|Estimated treatment difference|30.7|||<|0.0001|TWO_SIDED|95.0|26.6|34.8|||ANOVA|||The intensity of pain was analysed by a fixed analysis of variance model with VAS score as the dependent variable, and product, injection side (right side, left side), injection number (first injection, second injection), and participant as fixed effects.||34.8|26.6|<0.0001
72595030|NCT04068688|144721327|OTHER|||||||1|||||||Wilcoxon (Mann-Whitney)|||||||1.00
72595031|NCT04068688|144721327|OTHER|||||||0.914|||||||Wilcoxon (Mann-Whitney)|||||||0.914
72595032|NCT04068688|144721328|OTHER|||||||0.655|||||||Wilcoxon (Mann-Whitney)|||||||0.655
72595033|NCT04068688|144721328|OTHER|||||||0.564|||||||Wilcoxon (Mann-Whitney)|||||||0.564
72595034|NCT04068688|144721329|OTHER|||||||0.014|||||||Wilcoxon (Mann-Whitney)|||||||0.014
72595035|NCT04068688|144721329|OTHER|||||||0.705|||||||Wilcoxon (Mann-Whitney)|||||||0.705
72595036|NCT04068688|144721330|OTHER|||||||0.096|||||||Wilcoxon (Mann-Whitney)|||||||0.096
72595037|NCT04068688|144721330|OTHER|||||||0.732|||||||Wilcoxon (Mann-Whitney)|||||||0.732
72595038|NCT04068688|144721331|OTHER|||||||1|||||||Wilcoxon (Mann-Whitney)|||||||1.00
72595039|NCT04068688|144721331|OTHER|||||||0.705|||||||Wilcoxon (Mann-Whitney)|||||||0.705
72595040|NCT04068688|144721332|OTHER|||||||0.442|||||||Wilcoxon (Mann-Whitney)|||||||0.442
72595041|NCT04068688|144721332|OTHER|||||||0.458|||||||Wilcoxon (Mann-Whitney)|||||||0.458
72595042|NCT04068688|144721333|OTHER|||||||0.35|||||||Wilcoxon (Mann-Whitney)|||||||0.35
72595043|NCT04068688|144721333|OTHER|||||||0.68|||||||Wilcoxon (Mann-Whitney)|||||||0.68
72595044|NCT04068688|144721337|OTHER|||||||0.004|||||||Wilcoxon (Mann-Whitney)|||||||0.004
72595045|NCT04068688|144721338|OTHER|||||||0.084|||||||Wilcoxon (Mann-Whitney)|||||||0.084
72595046|NCT04068688|144721339|OTHER|||||||0.42|||||||Wilcoxon (Mann-Whitney)|||||||0.42
72595047|NCT04068688|144721339|OTHER|||||||0.171|||||||Wilcoxon (Mann-Whitney)|||||||0.171
72595048|NCT04068688|144721340|OTHER|||||||0.011|||||||Wilcoxon (Mann-Whitney)|||||||0.011
72595049|NCT04068688|144721340|OTHER|||||||0.049|||||||Wilcoxon (Mann-Whitney)|||||||0.049
72595050|NCT04068688|144721344|OTHER|||||||0.003|||||||Wilcoxon (Mann-Whitney)|||||||0.003
72595051|NCT04068688|144721344|OTHER|||||||0.139|||||||Wilcoxon (Mann-Whitney)|||||||0.139
72595052|NCT02248974|144721356|SUPERIORITY|||||||0.01|||||||Mixed Models Analysis|||The model uses a general linear mixed model with fixed effects for baseline Knowledge Scale score, time (discrete), arm, and a time-arm interaction term. The matrix of correlated residual terms assumes an unstructured format.||||0.01
72595053|NCT02248974|144721357|SUPERIORITY|||||||0.47|||||||Mixed Models Analysis|||The model uses a general linear mixed model with fixed effects for baseline KS score, time (discrete), arm, and a time-arm interaction term. The matrix of correlated residual terms assumes an unstructured format.||||0.47
72595054|NCT02248974|144721358|SUPERIORITY|||||||0.12|||||||Wilcoxon (Mann-Whitney)|||Used Wilcoxon 2-sample test to see if DA group had significantly better (i.e. lower) Decisional Conflict Scores than no-DA (Control) group.||||0.12
72415086|NCT04773587|144340350|SUPERIORITY||Odds Ratio (OR)|2.56|||<|0.0001|TWO_SIDED|95.0|1.707|3.843|||Cochran-Mantel-Haenszel|Stratified by pooled study site and vIGA-AD randomization strata with multiple imputation of missing observations|Stratified by pooled study stie and vIGA-AD randomization strata with multiple imputation of missing observations|vIGA-AD Score of 'Clear' or 'Almost Clear' at Week 4||3.843|1.707|<0.0001
72415087|NCT04773587|144340351|SUPERIORITY||Odds Ratio (OR)|4.28|||<|0.0001|TWO_SIDED|95.0|2.31|7.926|||Cochran-Mantel-Haenszel|Stratified by pooled study site and vIGA-AD randomization strata with multiple imputation of missing observations|Stratified by pooled study site and vIGA-AD randomization strata with multiple imputation of missing observations|vIGA-AD Success at Week 2||7.926|2.310|<0.0001
72415088|NCT04773587|144340352|SUPERIORITY||Odds Ratio (OR)|25.41|||<|0.0001|TWO_SIDED|95.0|2.815|229.388|||Cochran-Mantel-Haenszel|Stratified by pooled study site and vIGA-AD randomization strata with multiple imputation of missing observations|Stratified by pooled study site and vIGA-AD randomization strata with multiple imputation of missing observations|vIGA-AD Success at Week 1||229.388|2.815|<0.0001
72415089|NCT04773587|144340353|SUPERIORITY||Odds Ratio (OR)|3.62|||<|0.0001|TWO_SIDED|95.0|2.217|5.911|||Cochran-Mantel-Haenszel|Stratified by pooled study site and vIGA-AD randomization strata with multiple imputation of missing observations|Stratified by pooled study site and vIGA-AD randomization strata with multiple imputation of missing observations|vIGA-AD Score of 'Clear' or 'Almost Clear' at Week 2||5.911|2.217|<0.0001
72415090|NCT04773587|144340354|SUPERIORITY||Odds Ratio (OR)|3.46||||0.0002|TWO_SIDED|95.0|1.705|7.007|||Cochran-Mantel-Haenszel|Stratified by pooled study site and vIGA-AD randomization strata with multiple imputation of missing observations|Stratified by pooled study site and vIGA-AD randomization strata with multiple imputation of missing observations|vIGA-AD Score of 'Clear' or 'Almost Clear' at Week 1||7.007|1.705|0.0002
72595055|NCT02248974|144721359|SUPERIORITY|||||||0.79|||||||Wilcoxon (Mann-Whitney)|||Used Wilcoxon 2-sample test to see if DA group had significantly better (i.e. lower) Decisional Conflict Scores than no-DA (Control) group.||||0.79
72595056|NCT02248974|144721360|SUPERIORITY|||||||0.99|||||||Wilcoxon (Mann-Whitney)|||||||0.99
72595057|NCT02248974|144721361|SUPERIORITY|||||||0.94|||||||Wilcoxon (Mann-Whitney)|||||||0.94
72415091|NCT01808313|144340355|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|53.59|||<|0.001|TWO_SIDED|95.0|42.53|64.66|||t-test, 2 sided|||||64.66|42.53|<0.001
72415092|NCT01808313|144340356|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|64.36|||<|0.001|TWO_SIDED|95.0|48.72|80.0|||t-test, 2 sided|||||80.00|48.72|<0.001
72415093|NCT01808313|144340358|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon signed-rank test|||Week 12||||<0.001
72415094|NCT01808313|144340358|SUPERIORITY_OR_OTHER|||||||0.003||95.0|||||Wilcoxon signed-rank test|||Week 24||||0.003
72415095|NCT01808313|144340359|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.44|||<|0.001|TWO_SIDED|95.0|0.366|0.519|||Wilcoxon signed-rank test||Week 12|||0.519|0.366|<0.001
72415096|NCT01808313|144340359|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.37|||<|0.001|TWO_SIDED|95.0|0.303|0.453|||Wilcoxon signed-rank test||Week 24|||0.453|0.303|<0.001
72415097|NCT03301051|144340399|OTHER|Vaccine Efficacy (VE) of VLP vaccine versus placebo = (1 - attack rate in vaccinated participants \[ARV\]/attack rate in unvaccinated participants \[ARU\]) x 100%.|Vaccine Efficacy|34.9|||||TWO_SIDED|95.0|17.6|48.6|||||The VE success criterion is defined as a \>40% lower limit of the two-sided 95% confidence interval (CI).|||48.6|17.6|
72415098|NCT03301051|144340400|OTHER|VE of VLP vaccine versus placebo = (1 - ARV/ARU) x 100%.|Vaccine Efficacy|38.6|||||TWO_SIDED|95.0|27.6|48.0|||||The VE success criterion is defined as a \>40% lower limit of the two-sided 95% CI.|||48.0|27.6|
72415099|NCT03301051|144340401|OTHER|VE of VLP vaccine versus placebo = (1 - ARV/ARU) x 100%.|Vaccine Efficacy|33.8|||||TWO_SIDED|95.0|14.9|48.5|||||The VE success criterion is defined as a \>40% lower limit of the two-sided 95% CI.|||48.5|14.9|
72415100|NCT03301051|144340402|OTHER|VE of VLP vaccine versus placebo = (1 - ARV/ARU) x 100%.|Vaccine Efficacy|37.6|||||TWO_SIDED|95.0|25.1|48.0|||||The VE success criterion is defined as a \>40% lower limit of the two-sided 95% CI.|||48.0|25.1|
72415101|NCT03301051|144340403|OTHER|VE of VLP vaccine versus placebo = (1 - ARV/ARU) x 100%.|Vaccine Efficacy|6.2|||||TWO_SIDED|95.0|0.8|11.3|||||The VE success criterion is defined as a \>40% lower limit of the two-sided 95% CI.|||11.3|0.8|
72595058|NCT02248974|144721362|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||||||1.00
72595059|NCT02248974|144721363|SUPERIORITY|||||||0.95|||||||Wilcoxon (Mann-Whitney)|||||||0.95
72595060|NCT02248974|144721364|SUPERIORITY|||||||0.13|||||||Wilcoxon (Mann-Whitney)|||||||0.13
72595061|NCT02248974|144721365|SUPERIORITY|||||||0.006|||||||Wilcoxon (Mann-Whitney)|||||||0.006
72595062|NCT02248974|144721366|SUPERIORITY|||||||0.27|||||||Wilcoxon (Mann-Whitney)|||||||0.27
72595063|NCT02248974|144721368|SUPERIORITY|||||||0.65|||||||Wilcoxon (Mann-Whitney)|||||||0.65
72595064|NCT02248974|144721369|SUPERIORITY|||||||0.74|||||||Wilcoxon (Mann-Whitney)|||||||0.74
72595065|NCT02248974|144721373|SUPERIORITY|||||||0.6|||||||Wilcoxon (Mann-Whitney)|||||||0.60
72595066|NCT02248974|144721374|SUPERIORITY|||||||0.27|||||||Wilcoxon (Mann-Whitney)|||||||0.27
72595067|NCT02248974|144721375|SUPERIORITY|||||||0.45|||||||Wilcoxon (Mann-Whitney)|||||||0.45
72595068|NCT02248974|144721376|SUPERIORITY|||||||0.006|||||||Wilcoxon (Mann-Whitney)|||||||0.006
72595069|NCT02248974|144721377|SUPERIORITY|||||||0.01|||||||Wilcoxon (Mann-Whitney)|||||||0.01
72595070|NCT02248974|144721378|SUPERIORITY|||||||0.03|||||||Wilcoxon (Mann-Whitney)|||||||0.03
72415102|NCT00622167|144340429|SUPERIORITY_OR_OTHER|||||||0||0.0|||||Not done|||Plaque characteristics including plaque cross-sectional diameter, area measurements, plaque volume, and plaque morphology would be compared between IBIVUS, DSCT and angiography.||||0
72595071|NCT02248974|144721380|SUPERIORITY|||||||0.77|||||||Wilcoxon (Mann-Whitney)|||||||0.77
72595072|NCT02248974|144721381|SUPERIORITY|||||||0.74|||||||Wilcoxon (Mann-Whitney)|||||||0.74
72595073|NCT02248974|144721382|SUPERIORITY|||||||0.12|||||||Fisher Exact|||||||0.12
72595074|NCT02248974|144721389|SUPERIORITY|||||||0.98|||||||Fisher Exact|||||||0.98
72595075|NCT02248974|144721390|SUPERIORITY|||||||0.2|||||||Fisher Exact|||||||0.20
72595076|NCT02332239|144721391|SUPERIORITY||Mean Difference (Final Values)|-7.48|STANDARD_ERROR_OF_MEAN|4.11||0.07|TWO_SIDED||||||Mixed effects longitudinal regression||d=0.37|BDI Score where baseline \>=20: 8 week||||0.07
72595077|NCT02332239|144721392|SUPERIORITY||Median Difference (Final Values)|-7.29|STANDARD_ERROR_OF_MEAN|2.62||0.01|TWO_SIDED||||||quantile regression models|Controlled for baseline and gender|d=0.46|CTS Score where baseline \>=4: 8 week||||0.01
72595078|NCT02332239|144721395|SUPERIORITY|||||||0.33|||||||t-test, 2 sided|||||||0.33
72595079|NCT00396877|144721398|SUPERIORITY_OR_OTHER||Relative Risk Reduction (%)|11.1||||0.434|TWO_SIDED|95.0|-19.2|33.6||The a-priori threshold for statistical significance was \< 0.035 reflecting the adjustment for interim analyses. No other adjustment for multiplicity was made.|Log Rank|A two-sided log-rank test was used.|The Relative Risk Reduction (Clopidogrel versus placebo) and its corresponding 95% confidence interval were estimated using Cox's proportional hazards model.|"Due to the limited knowledge in this population, 3 interim analyses were performed at approximatively 40%, 60%, 80% and 100% of of the maximum number of 172 required primary efficacy events to evaluate the effect of Clopidogrel on the primary endpoint with the potential to end the trial in case of a clear efficacy advantage for Clopidogrel.~The study was designed with 80% power and an overall type I error rate of 5%."||33.6|-19.2|0.4340
72595080|NCT00334802|144721401|SUPERIORITY_OR_OTHER|||||||0.169||95.0||||P-value for Dose Level 1 Responders (Complete Response + Partial Response)|t-test, 2 sided|||||||0.169
72595081|NCT00334802|144721401|SUPERIORITY_OR_OTHER|||||||0.001||95.0||||P-value for Dose Level 2 Responders (Complete Response + Partial Response)|t-test, 2 sided|||||||0.001
72595082|NCT03436199|144721408|SUPERIORITY||Risk Difference (RD)|0.064||||0.0811|TWO_SIDED|95.0|-0.008|0.136|||Farrington-Manning score test|The Miettinen-Nurminen method was used to obtain the 95% confidence intervals.||||0.136|-0.008|0.0811
72595083|NCT03436199|144721408|SUPERIORITY||Risk Difference (RD)|0.098||||0.0104|TWO_SIDED|95.0|0.023|0.174|||Farrington-Manning score test|The Miettinen-Nurminen method was used to obtain the 95% confidence intervals.||||0.174|0.023|0.0104
72595084|NCT03436199|144721409|SUPERIORITY||Mean Difference (Net)|0.12|STANDARD_ERROR_OF_MEAN|0.048||0.0162|TWO_SIDED|95.0|0.02|0.21|||Mixed Models Analysis|Mixed models analysis with repeated measures||||0.21|0.02|0.0162
72595085|NCT03436199|144721409|SUPERIORITY||Mean Difference (Net)|0.12|STANDARD_ERROR_OF_MEAN|0.05||0.0142|TWO_SIDED|95.0|0.02|0.22|||Mixed Models Analysis|Mixed models analysis with repeated measures||||0.22|0.02|0.0142
72595086|NCT03436199|144721410|SUPERIORITY||Mean Difference (Net)|-0.79|STANDARD_ERROR_OF_MEAN|0.538||0.1424|TWO_SIDED|95.0|-1.85|0.27|||Mixed Models Analysis|Mixed models analysis with repeated measures||||0.27|-1.85|0.1424
72595087|NCT03436199|144721410|SUPERIORITY||Mean Difference (Net)|-0.04|STANDARD_ERROR_OF_MEAN|0.56||0.9467|TWO_SIDED|95.0|-1.14|1.06|||Mixed Models Analysis|Mixed models analysis with repeated measures||||1.06|-1.14|0.9467
72595088|NCT03436199|144721411|SUPERIORITY||Mean Difference (Net)|4.143|STANDARD_ERROR_OF_MEAN|1.7389||0.0176|TWO_SIDED|95.0|0.726|7.56|||Mixed Models Analysis|Mixed models analysis with repeated measures||||7.560|0.726|0.0176
72595089|NCT03436199|144721411|SUPERIORITY||Mean Difference (Net)|3.529|STANDARD_ERROR_OF_MEAN|1.8196||0.053|TWO_SIDED|95.0|-0.046|7.104|||Mixed Models Analysis|Mixed models analysis with repeated measures||||7.104|-0.046|0.0530
72595090|NCT01886781|144721428|NON_INFERIORITY_OR_EQUIVALENCE|To determine an effect size of 0.64 with 80% power, a sample size of 27 for each group (D-IBS, C-IBS and controls), with a type 1 error of 5% using a two sided test was sufficient. Sample size based on expected behaviour of primary outcome measure. The minimally clinically important difference based on the primary outcome measure with the instrument used was 50 points.|||||<|0.05|TWO_SIDED|95.0|||||Mixed Models Analysis|||An intention-to -treat (ITT) analysis was performed on all patients who underwent randomization (n = 81). The results of the ITT analysis are presented. Changes in Severity Score was examined using the mixed model for analysis of variance to account for missing data. This model used group (treatment vs control) \& time as factors.||||<0.05
72595091|NCT01672294|144721453|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.5376|||<|0.511|TWO_SIDED|95.0|-1.0776|2.1528||Between Outlook Intervention and Attention Control caregivers at 5 weeks|Mixed Models Analysis|||Note- missing the first follow up at 5 weeks did not prohibit an individual from participating at the second follow up at 8 weeks.||2.1528|-1.0776|<0.511
72595092|NCT01672294|144721453|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.4275||||0.6348|TWO_SIDED|95.0|-1.3505|2.2055||Between Outlook Intervention and Attention Control caregivers at 8 weeks|Mixed Models Analysis|||Note- missing the first follow up at 5 weeks did not prohibit an individual from participating at the second follow up at 8 weeks.||2.2055|-1.3505|0.6348
72595093|NCT01672294|144721454|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.6836||||0.5225|TWO_SIDED|95.0|-1.4278|2.795|||Mixed Models Analysis|||Comparison at 5 weeks Note- missing the first follow up at 5 weeks did not prohibit an individual from participating at the second follow up at 8 weeks.||2.7950|-1.4278|0.5225
72595094|NCT01672294|144721454|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.2764||||0.1972|TWO_SIDED|95.0|-0.6728|3.2257|||Mixed Models Analysis|||Comparison at 8 weeks. Note-missing the first follow up at 5 weeks did not prohibit an individual from participating at the second follow up at 8 weeks.||3.2257|-0.6728|0.1972
72595095|NCT01672294|144721455|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.9358|||<|0.3332|TWO_SIDED|95.0|-0.9726|2.8443|||Mixed Models Analysis|||Between Outlook Intervention caregivers and active control caregivers at 5 weeks Note- missing the first follow up at 5 weeks did not prohibit an individual from participating at the second follow up at 8 weeks.||2.8443|-0.9726|<0.3332
72595096|NCT01672294|144721455|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.6929||||0.3842|TWO_SIDED|95.0|-0.8783|2.2642||Note-missing the first follow up at 5 weeks did not prohibit an individual from participating at the second follow up at 8 weeks|Mixed Models Analysis|||Between Outlook Intervention caregivers and active control caregivers at 8 weeks Note - Missing the first follow up at 5 weeks did not prohibit an individual from participating at the second follow up at 8 weeks||2.2642|-0.8783|0.3842
72595097|NCT01672294|144721456|SUPERIORITY_OR_OTHER||expected change in difference in logs|0.0593||||0.8748|TWO_SIDED|95.0|-0.6784|0.797|||Standard negative binomial with offset||The expected change in the difference of the logs of expected Days in VA inpatient care or ED.|||0.797|-0.6784|0.8748
72415103|NCT04370054|144340533|NON_INFERIORITY|A repeated measures negative binomial regression model was used to test non-inferiority with non-inferiority margin = 3 bleeds/year at the one-sided alpha level = 0.025.|Mean Difference (Final Values)|-3.49|||=|0.004|TWO_SIDED|95.0|-6.06|-0.91||One-sided p-value is reported.|Generalized linear model (GLM)||Difference in mean = Mean PF-07055480 Total ABR - Mean FVIII Prophylaxis Total ABR.|A repeated measures GLM was used with bleeds as dependent variable in negative binomial distribution, an interaction of duration by treatment, and 'participant' as random and treatment \& duration of follow-up as fixed effect.||-0.91|-6.06|=0.0040
72415104|NCT04370054|144340534|SUPERIORITY||||||=|0.0086||||||One-sided p-value is reported.|One-sided exact binomial proportion test|||||||=0.0086
72415105|NCT04370054|144340535|NON_INFERIORITY|A repeated measures negative binomial regression model was used to test non-inferiority with non-inferiority margin = 3 bleeds/year at the one-sided alpha level = 0.025.|Mean Difference (Final Values)|-4.01|||<|0.0001|TWO_SIDED|95.0|-5.57|-2.45||One-sided p-value is reported.|Repeated measures GLM||Difference in mean = Mean PF-07055480 Total ABR - Mean FVIII Prophylaxis Total ABR.|A repeated measures GLM was used with bleeds as dependent variable in negative binomial distribution, an interaction of duration by treatment, and 'participant' as random and treatment \& duration of follow-up as fixed effect.||-2.45|-5.57|<0.0001
72415106|NCT04370054|144340536|SUPERIORITY||Mean Difference (Final Values)|-124.18|||<|0.0001|TWO_SIDED|95.0|-139.47|108.89||One-sided p-value is reported.|Paired t-test||Treatment Difference = (PF-07055480 AIR - FVIII Prophylaxis AIR).|||108.89|-139.47|<0.0001
72415107|NCT04370054|144340538|SUPERIORITY||Mean Difference (Final Values)|-4076.06|||<|0.0001|TWO_SIDED|95.0|-4728.3|-3423.8||One-sided p-value is reported.|Paired t-test||Treatment Difference (FVIII Consumption post-IP Infusion - FVIII Consumption during FVIII Prophylaxis).|||-3423.8|-4728.3|<0.0001
72415108|NCT04953390|144340631|OTHER|||||||0.004|||||||ANOVA|||||||0.004
72415109|NCT04953390|144340632|OTHER|||||||0.029|||||||ANOVA|||||||.029
72415110|NCT04953390|144340633|OTHER|||||||0.0002|||||||ANOVA|||||||0.0002
72415111|NCT04953390|144340634|OTHER|||||||0.14|||||||t-test, 2 sided|T-test done on DIR2 and DIR3 results only, as the conditions were equal for these two settings. DIR1 was tested in a different condition.||All three DIR settings were tested, but only the DIR2 and DIR3 were compared in t-test. This is because DIR1 mic setting was tested in a different condition (i.e. softer noise).||||.14
72415112|NCT04953390|144340637|OTHER|||||||0.0003|||||||ANOVA|||||||.0003
72415113|NCT02008890|144340638|SUPERIORITY||Odds Ratio (OR)|1.33||||0.5722|TWO_SIDED|95.0|0.5|3.53|||Regression, Logistic|with factors treatment, country, body weight at baseline visit (\> 90 kg or \>= 90kg) and presence of plaque-type psoriasis||||3.53|0.50|0.5722
72415114|NCT02008890|144340638|SUPERIORITY||Odds Ratio (OR)|2.62||||0.0411|TWO_SIDED|95.0|1.04|6.6|||Regression, Logistic|with factors treatment, country, body weight at baseline visit (\> 90 kg or \>= 90kg) and presence of plaque-type psoriasis||||6.60|1.04|0.0411
72415115|NCT02008890|144340639|SUPERIORITY||Mean Difference (Final Values)|-0.56||||0.9431|TWO_SIDED|95.0|-4.59|3.47|||Regression, Linear|with factors treatment, country, body weight at baseline visit (\> 90 kg or \>= 90kg) and presence of plaque-type psoriasis||||3.47|-4.59|0.9431
72595098|NCT01672294|144721457|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01777||||0.7687|TWO_SIDED|95.0|-0.1372|0.1017||Between Caregiver Outlook - Caregiver and Relaxation Meditation - Caregiver at 5 weeks|Mixed Models Analysis|||"Between Outlook Intervention caregivers and active control caregivers at 5 weeks.~Note- missing the first follow up at 5 weeks did not prohibit an individual from participating at the second follow up at 8 weeks."||0.1017|-0.1372|0.7687
72595099|NCT01672294|144721457|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.00087||||0.9863|TWO_SIDED|95.0|-0.1003|0.09861||Between Caregiver Outlook - Caregiver and Relaxation Meditation - Caregiver at 8 weeks|Mixed Models Analysis|||Between Outlook Intervention caregivers and active control caregivers at 8 weeks Note- missing the first follow up at 5 weeks did not prohibit an individual from participating at the second follow up at 8 weeks.||0.09861|-0.1003|0.9863
72595100|NCT01672294|144721458|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01166||||0.9221|TWO_SIDED|95.0|-0.2475|0.2241|||Mixed Models Analysis|||At 5 weeks - Completion subscale||0.2241|-0.2475|0.9221
72415116|NCT02008890|144340639|SUPERIORITY||Mean Difference (Final Values)|-3.13||||0.1576|TWO_SIDED|95.0|-7.14|0.88|||Regression, Linear|with factors treatment, country, body weight at baseline visit (\> 90 kg or \>= 90kg) and presence of plaque-type psoriasis||||0.88|-7.14|0.1576
72595101|NCT01672294|144721458|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1154||||0.3249|TWO_SIDED|95.0|-0.3466|0.1158||Between Caregiver Outlook - Caregiver and Relaxation Meditation - Caregiver at 8 weeks|Mixed Models Analysis|||Comparison at 8 week time point Note- Missing first follow up at 5 weeks did not prohibit an individual from participating at the second follow up at 8 week.||0.1158|-0.3466|0.3249
72415117|NCT02207816|144340646|SUPERIORITY||Vaccine efficacy|74.38||||0.2235|TWO_SIDED|95.0|-130.0|97.14|||Negative binomial regression|Mixed model without random effect \[Lievens, 2011\].||Vaccine efficacy (VE)/ incidence comparison against all episodes of severe malaria were estimated as 1-incidence ratio (IR; total number of events/follow-up time in the GSK257049 \[5-17M\] Group over the total number of events/follow-up time in the VeroRab Comparator \[5-17M\] Group).||97.14|-130|0.2235
72595102|NCT00926536|144721510|SUPERIORITY_OR_OTHER||Mean Difference (Net)|71.6|||<|0.001|TWO_SIDED|||||Decrease in DAP in C-arm CT +DSA group when compared to DSA only|Mixed Models Analysis|||||||<.001
72595103|NCT00926536|144721511|SUPERIORITY_OR_OTHER||Mean Difference (Net)|158.3||||0.017|TWO_SIDED|||||Decrease in CD in C-arm CT +DSA group when compared to DSA only|Mixed Models Analysis|||||||0.017
72595104|NCT01080391|144721515|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.69|||<|0.0001|TWO_SIDED|95.0|0.57|0.834||Analysis was stratified by β2 microglobulin levels (\< 2.5 mg/L vs. ≥ 2.5 mg/L), prior bortezomib (no vs. yes), and prior lenalidomide (no vs. yes)|Log Rank|The stopping boundary for this analysis was 0.0127 based on 1-sided significance level (O'Brien-Fleming with Lan-DeMets spending function).||||0.834|0.570|< 0.0001
72415118|NCT02207816|144340646|SUPERIORITY||Vaccine efficacy|-9.57||||0.8972|TWO_SIDED|95.0|-339.0|72.64|||Negative binomial regression|Mixed model without random effect \[Lievens, 2011\].||Vaccine efficacy (VE)/ incidence comparison against all episodes of severe malaria were estimated as 1-incidence ratio (IR; total number of events/follow-up time in the GSK257049 Comparator \[5-17M\] Group over the total number of events/follow-up time in the VeroRab Comparator \[5-17M\] Group).||72.64|-339|0.8972
72595105|NCT01080391|144721516|SUPERIORITY|The stopping boundary for this analysis was 0.0231 based on 1-sided significance level (O'Brien-Fleming with Lan-DeMets spending function).|Hazard Ratio (HR)|0.794||||0.0045|TWO_SIDED|95.0|0.667|0.945|||Log Rank|Analysis was stratified by β2 microglobulin levels (\< 2.5 mg/L vs. ≥ 2.5 mg/L), prior bortezomib (no vs. yes), and prior lenalidomide (no vs. yes).||The final analysis of OS was to be performed after 510 deaths occur. A total of 510 deaths would provide 85% power to detect, with a 1-sided significance level of 0.025, a hazard ratio of 0.765 corresponding to a 23.5% reduction in risk for death for CRd versus Rd (39.2 vs. 30.0 months, respectively).||0.945|0.667|0.0045
72595106|NCT01080391|144721517|SUPERIORITY||Odds Ratio (OR)|3.472|||<|0.0001|TWO_SIDED|95.0|2.411|5.001|||Cochran-Mantel Haenszel chi-square test|Cochran-Mantel Haenszel chi-square test with β2 macroglobulin level, prior bortezomib, and prior lenalidomide as stratification factors.|The odds ratio and 95% CI were estimated using the Mantel-Haenszel method.|||5.001|2.411|< 0.0001
72595107|NCT01080391|144721518|SUPERIORITY||Odds Ratio (OR)|1.897||||0.0044|TWO_SIDED|95.0|1.17|3.08|||Cochran-Mantel Haenszel chi-square test|Cochran-Mantel Haenszel chi-square test with β2 macroglobulin level, prior bortezomib, and prior lenalidomide as stratification factors.|The odds ratio and 95% CI were estimated using the Mantel-Haenszel method.|||3.08|1.17|0.0044
72595108|NCT00672841|144721522|SUPERIORITY_OR_OTHER||Sensitivity|100.0||||||95.0|||||Sensitivity %||Sensitivity \[1\] = (True positives \[n=6\]/ True positives + False negatives \[n=6\])|Clinical sensitivity of the BDG test was calculated for both study groups combined||||
72595109|NCT00672841|144721522|SUPERIORITY_OR_OTHER||Specificity|50.0||||||95.0|||||% Specificity||Specificity \[0.50\]= True negatives \[n=28\]/ True negatives + False positives \[56\])|Clinical specificity of the BDG test was calculated for the study groups combined||||
72595110|NCT00672841|144721524|SUPERIORITY_OR_OTHER||Percent Sensitivity|100.0||||||95.0|||||Sensitivity||Sensitivity = (true positives \[n=6\]/true positives + false negative \[n=6\])|The clinic sensitivity of the BDG test was calculated for both study groups combined||||
72415119|NCT02207816|144340646|SUPERIORITY||Vaccine efficacy|30.58||||0.5333|TWO_SIDED|95.0|-119.0|78.0|||Negative binomial regression|Mixed model without random effect \[Lievens, 2011\].||Vaccine efficacy (VE)/ incidence comparison against all episodes of severe malaria were estimated as 1-incidence ratio (IR; total number of events/follow-up time in the GSK257049 \[6-12W\] Group over the total number of events/follow-up time in the Menjugate Comparator \[6-12W\] Group).||78.00|-119|0.5333
72595111|NCT00672841|144721524|SUPERIORITY_OR_OTHER||Percent Specificity|52.0||||||95.0|||||Specificity||Specificity \[0.52\]= (True negatives \[n=30\]/True negatives + false positives \[n=58\])|The clinical specificity of the BDG test was calculated for both study groups combined||||
72595112|NCT03578146|144721526|SUPERIORITY||Least Squares Means (Difference)|-73.14||||0.0121|TWO_SIDED||||||ANCOVA|||||||0.0121
72595113|NCT03578146|144721526|SUPERIORITY||Least Squares Means (Difference)|-153.99|||<|0.0001|TWO_SIDED||||||ANCOVA|||||||<0.0001
72595114|NCT03578146|144721526|SUPERIORITY||Least Squares Means (Difference)|-189.57|||<|0.0001|TWO_SIDED||||||ANCOVA|||||||<0.0001
72595115|NCT03578146|144721526|SUPERIORITY||Least Squares Means (Difference)|-239.3|||<|0.0001|TWO_SIDED||||||ANCOVA|||||||<0.0001
72595116|NCT03578146|144721526|SUPERIORITY||Least Squares Means (Difference)|-231.12|||<|0.0001|TWO_SIDED||||||ANCOVA|||||||<0.0001
72595117|NCT03578146|144721527|SUPERIORITY||Least Squares Means (Difference)|52837.94|||<|0.0001|TWO_SIDED||||||ANCOVA|||||||<0.0001
72415120|NCT02207816|144340646|SUPERIORITY||Vaccine efficacy|44.2||||0.3523|TWO_SIDED|95.0|-90.9|83.69|||Negative binomial regression|Mixed model without random effect \[Lievens, 2011\].||Vaccine efficacy (VE)/ incidence comparison against all episodes of severe malaria were estimated as 1-incidence ratio (IR; total number of events/follow-up time in the GSK257049 Comparator \[6-12W\] Group over the total number of events/follow-up time in the Menjugate Comparator \[6-12W\] Group).||83.69|-90.9|0.3523
72595118|NCT03578146|144721527|SUPERIORITY||Least Squares Means (Difference)|110388.3|||<|0.0001|TWO_SIDED||||||ANCOVA|||||||<0.0001
72595119|NCT03578146|144721527|SUPERIORITY||Least Squares Means (Difference)|163880.7|||<|0.0001|TWO_SIDED||||||ANCOVA|||||||<0.0001
72595120|NCT03578146|144721527|SUPERIORITY||Least Squares Means (Difference)|263236.5|||<|0.0001|TWO_SIDED||||||ANCOVA|||||||<0.0001
72595121|NCT03578146|144721527|SUPERIORITY||Least Squares Means (Difference)|270297.2|||<|0.0001|TWO_SIDED||||||ANCOVA|||||||<0.0001
72595122|NCT03578146|144721528|SUPERIORITY||Least Squares Means (Difference)|-9.91||||0.002|TWO_SIDED||||||ANCOVA|||||||0.002
72595123|NCT03578146|144721528|SUPERIORITY||Least Squares Means (Difference)|-15.06|||<|0.0001|TWO_SIDED||||||ANCOVA|||||||<0.0001
72595124|NCT03578146|144721528|SUPERIORITY||Least Squares Means (Difference)|-17.53|||<|0.0001|TWO_SIDED||||||ANCOVA|||||||<0.0001
72595125|NCT03578146|144721528|SUPERIORITY||Least Squares Means (Difference)|-17.05|||<|0.0001|TWO_SIDED||||||ANCOVA|||||||<0.0001
72595126|NCT03578146|144721528|SUPERIORITY||Least Squares Means (Difference)|-19.33|||<|0.0001|TWO_SIDED||||||ANCOVA|||||||<0.0001
72595127|NCT01260584|144721564|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.7|STANDARD_ERROR_OF_MEAN|4.11||0.0624|TWO_SIDED|95.0|-0.4|15.8|||Mixed Models Analysis|||For the sample size calculations for the co-primary endpoints, no Type 1 error rate was adjusted and both co-primary endpoints will be tested at the 0.05 level.||15.8|-0.4|0.0624
72595128|NCT01260584|144721564|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|31.8|STANDARD_ERROR_OF_MEAN|3.35|<|0.0001|TWO_SIDED|95.0|25.1|38.4|||Mixed Models Analysis|||||38.4|25.1|<0.0001
72595129|NCT01260584|144721564|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.8|STANDARD_ERROR_OF_MEAN|4.08||0.244|TWO_SIDED|95.0|-3.3|12.8|||Mixed Models Analysis|||||12.8|-3.3|0.2440
72595130|NCT01260584|144721564|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|34.7|STANDARD_ERROR_OF_MEAN|3.17|<|0.0001|TWO_SIDED|95.0|28.4|41.0|||Mixed Models Analysis|||||41.0|28.4|<0.0001
72595131|NCT01260584|144721564|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|27.0|STANDARD_ERROR_OF_MEAN|4.14|<|0.0001|TWO_SIDED|95.0|18.8|35.2|||Mixed Models Analysis|||||35.2|18.8|<0.0001
72595132|NCT01260584|144721565|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-36.2|STANDARD_ERROR_OF_MEAN|12.65||0.0048|TWO_SIDED|95.0|-61.1|-11.2|||Mixed Models Analysis|||||-11.2|-61.1|0.0048
72595133|NCT01260584|144721565|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-93.8|STANDARD_ERROR_OF_MEAN|11.54|<|0.0001|TWO_SIDED|95.0|-116.7|-71.0|||Mixed Models Analysis|||||-71.0|-116.7|<0.0001
72595134|NCT01260584|144721565|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-21.2|STANDARD_ERROR_OF_MEAN|12.53||0.0924|TWO_SIDED|95.0|-45.9|3.5|||Mixed Models Analysis|||||3.5|-45.9|0.0924
72595135|NCT01260584|144721565|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-108.8|STANDARD_ERROR_OF_MEAN|10.85|<|0.0001|TWO_SIDED|95.0|-130.3|-87.3|||Mixed Models Analysis|||||-87.3|-130.3|<0.0001
72595136|NCT01260584|144721565|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-72.6|STANDARD_ERROR_OF_MEAN|12.73|<|0.0001|TWO_SIDED|95.0|-97.8|-47.5|||Mixed Models Analysis|||||-47.5|-97.8|<0.0001
72595137|NCT01260584|144721566|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.6|STANDARD_ERROR_OF_MEAN|3.72||0.0423|TWO_SIDED|95.0|-15.0|-0.3|||Mixed Models Analysis|||||-0.3|-15.0|0.0423
72595138|NCT01260584|144721566|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-22.7|STANDARD_ERROR_OF_MEAN|3.19|<|0.0001|TWO_SIDED|95.0|-29.0|-16.4|||Mixed Models Analysis|||||-16.4|-29.0|<0.0001
72595139|NCT01260584|144721566|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.8|STANDARD_ERROR_OF_MEAN|3.7||0.1184|TWO_SIDED|95.0|-13.1|1.5|||Mixed Models Analysis|||||1.5|-13.1|0.1184
72595140|NCT01260584|144721566|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-24.5|STANDARD_ERROR_OF_MEAN|3.02|<|0.0001|TWO_SIDED|95.0|-30.5|-18.5|||Mixed Models Analysis|||||-18.5|-30.5|<0.0001
72595141|NCT01260584|144721566|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.9|STANDARD_ERROR_OF_MEAN|3.76|<|0.0001|TWO_SIDED|95.0|-24.3|-9.5|||Mixed Models Analysis|||||-9.5|-24.3|<0.0001
72595142|NCT01260584|144721567|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.06||||0.1331|TWO_SIDED|95.0|0.8|5.32|||Regression, Logistic|||||5.32|0.80|0.1331
72595143|NCT01260584|144721567|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.99||||0.5813|TWO_SIDED|95.0|0.17|23.65|||Regression, Logistic|||||23.65|0.17|0.5813
72595144|NCT01260584|144721567|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|16.54||||0.0127|TWO_SIDED|95.0|1.85|148.23|||Regression, Logistic|||||148.23|1.85|0.0127
72595145|NCT01260584|144721567|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|17.11||||0.0013|TWO_SIDED|95.0|3.13|93.65|||Regression, Logistic|||||93.65|3.13|0.0013
72595146|NCT01260584|144721568|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.34||||0.5684|TWO_SIDED|95.0|0.49|3.67|||Regression, Logistic|||||3.67|0.49|0.5684
72595147|NCT01260584|144721568|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.7||||0.0447|TWO_SIDED|95.0|1.05|42.92|||Regression, Logistic|||||42.92|1.05|0.0447
72595148|NCT01260584|144721568|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|58.64||||0.0003|TWO_SIDED|95.0|6.8|505.58|||Regression, Logistic|||||505.58|6.80|0.0003
72595149|NCT01260584|144721568|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|11.71||||0.0006|TWO_SIDED|95.0|2.95|46.52|||Regression, Logistic|||||46.52|2.95|0.0006
72595150|NCT01260584|144721569|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|110.7|||||TWO_SIDED|90.0|93.7|130.8|||Mixed Models Analysis|||Prasugrel active metabolite R-138727||130.8|93.7|
72595151|NCT01260584|144721569|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|118.4|||||TWO_SIDED|90.0|99.8|140.4|||Mixed Models Analysis|||active metabolite R-130964||140.4|99.8|
72595152|NCT01260584|144721570|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|117.9|||||TWO_SIDED|90.0|94.4|147.3|||Mixed Models Analysis||Estimation was based on the ratio of Geom. means between groups. Non-smoker is the denominator.|Prasugrel active metabolite R-138727||147.3|94.4|
72595153|NCT01260584|144721570|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|123.8|||||TWO_SIDED|90.0|98.6|155.4|||Mixed Models Analysis||Estimation was based on the ratio of Geom. means between groups. Non-smoker is the denominator.|Clopidogrel active metabolite R-130964||155.4|98.6|
72595154|NCT03434249|144721583|OTHER|||||||0.0001|||||||Chi-squared|||"According to the results of a previous trial that looked at a probiotic's effect on infants with CI, it was estimated that when the sample size in each group is 33, the study has 80% power to detect an absolute difference of 35% in the treatment success rate (15% in the Placebo group and 50% in the treatment group) with a 0,05 alpha level.~The number of infants that was included in the study was 80, with an expected maximum dropout rate of 20%."||||0.0001
72595155|NCT03434249|144721584|OTHER|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||||||0.001
72595156|NCT03434249|144721586|OTHER|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||||||0.001
72595157|NCT00561470|144721597|SUPERIORITY_OR_OTHER||Stratified Hazard Ratio|0.817||||0.0032|TWO_SIDED|95.34|0.713|0.937||Stratified Log-Rank test p-value. Stratified on ECOG Performance Status and prior Bevacizumab according to IVRS using the Cox Proportional Hazard Model. Significance threshold was set to 0.0466 using the O'Brien-Fleming alpha spending function.|Stratified Log-Rank test||Stratified on ECOG Performance Status (0 vs 1 vs 2) and prior Bevacizumab (yes vs no) according to IVRS using the Cox Proportional Hazard Model. Significance threshold was set to 0.0466 using the O'Brien-Fleming alpha spending function.|||0.937|0.713|0.0032
72595158|NCT00561470|144721598|SUPERIORITY_OR_OTHER||Stratified Hazard ratio|0.758||||7e-05|TWO_SIDED|99.99|0.578|0.995||Stratified on ECOG Performance Status (0 vs 1 vs 2) and prior Bevacizumab (yes vs no) according to IVRS|Stratified Log-Rank test||Stratified on ECOG Performance Status (0 vs 1 vs 2) and prior Bevacizumab (yes vs no) according to IVRS using the Cox Proportional Hazard Model.|||0.995|0.578|0.00007
72595159|NCT00561470|144721599|SUPERIORITY_OR_OTHER|||||||0.0001||95.0|||||Stratified Cochran-Mantel-Haenszel|Stratified on ECOG Performance Status (0 vs 1 vs 2) and Prior Bevacizumab (yes vs no) according to IVRS.||||||0.0001
72595160|NCT00824382|144721727|SUPERIORITY_OR_OTHER||Least Squares Mean for the difference|0.091|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001||95.0|0.051|0.131|||ANCOVA|||Olodaterol 2mcg - Placebo||0.131|0.051|<0.0001
72595161|NCT00824382|144721727|SUPERIORITY_OR_OTHER||Least Squares Mean for the difference|0.132|STANDARD_ERROR_OF_MEAN|0.021|<|0.0001||95.0|0.091|0.172|||ANCOVA|||Olodaterol 5mcg - Placebo||0.172|0.091|<0.0001
72595162|NCT00824382|144721727|SUPERIORITY_OR_OTHER||Least Squares Mean for the difference|0.132|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001||95.0|0.092|0.172|||ANCOVA|||Olodaterol 10mcg - Placebo||0.172|0.092|<0.0001
72595163|NCT00824382|144721728|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.081|STANDARD_ERROR_OF_MEAN|0.021||0.0002||95.0|0.039|0.124|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 2 mcg qd minus Placebo|||0.124|0.039|0.0002
72595164|NCT00824382|144721728|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.141|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001||95.0|0.098|0.184|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 5 mcg qd minus Placebo|||0.184|0.098|<0.0001
72595165|NCT00824382|144721728|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.157|STANDARD_ERROR_OF_MEAN|0.021|<|0.0001||95.0|0.115|0.199|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 10 mcg qd minus Placebo|||0.199|0.115|<0.0001
72595166|NCT00824382|144721729|SUPERIORITY_OR_OTHER||Least Squares Mean for the difference|0.138|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001||95.0|0.095|0.182|||ANCOVA|||Olodaterol 2mcg - Placebo||0.182|0.095|<0.0001
72595167|NCT00824382|144721729|SUPERIORITY_OR_OTHER||Least Squares Mean for the difference|0.197|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001||95.0|0.154|0.241|||ANCOVA|||Olodaterol 5mcg - Placebo||0.241|0.154|<0.0001
72595168|NCT00824382|144721729|SUPERIORITY_OR_OTHER||Least Squares Mean for the difference|0.193|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001||95.0|0.15|0.236|||ANCOVA|||Olodaterol 10mcg - Placebo||0.236|0.150|<0.0001
72595169|NCT00824382|144721730|SUPERIORITY_OR_OTHER||Least Squares Mean for the difference|0.146|STANDARD_ERROR_OF_MEAN|0.023|<|0.0001||95.0|0.101|0.191|||ANCOVA|||Olodaterol 2mcg - Placebo||0.191|0.101|<0.0001
72595170|NCT00824382|144721730|SUPERIORITY_OR_OTHER||Least Squares Mean for the difference|0.202|STANDARD_ERROR_OF_MEAN|0.023|<|0.0001||95.0|0.157|0.247|||ANCOVA|||Olodaterol 5mcg - Placebo||0.247|0.157|<0.0001
72595171|NCT00824382|144721730|SUPERIORITY_OR_OTHER||Least Squares Mean for the difference|0.196|STANDARD_ERROR_OF_MEAN|0.023|<|0.0001||95.0|0.151|0.24|||ANCOVA|||Olodaterol 10mcg - Placebo||0.240|0.151|<0.0001
72595172|NCT00824382|144721731|SUPERIORITY_OR_OTHER||Least Squares Mean for the difference|0.191|STANDARD_ERROR_OF_MEAN|0.043|<|0.0001||95.0|0.107|0.275|||ANCOVA|||Olodaterol 2mcg - Placebo||0.275|0.107|<0.0001
72595173|NCT00824382|144721731|SUPERIORITY_OR_OTHER||Least Squares Mean for the difference|0.191|STANDARD_ERROR_OF_MEAN|0.043|<|0.0001||95.0|0.106|0.276|||ANCOVA|||Olodaterol 5mcg - Placebo||0.276|0.106|<0.0001
72595174|NCT00824382|144721731|SUPERIORITY_OR_OTHER||Least Squares Mean for the difference|0.187|STANDARD_ERROR_OF_MEAN|0.042|<|0.0001||95.0|0.103|0.27|||ANCOVA|||Olodaterol 10mcg - Placebo||0.270|0.103|<0.0001
72595175|NCT00824382|144721732|SUPERIORITY_OR_OTHER||Least Squares Mean for the difference|0.253|STANDARD_ERROR_OF_MEAN|0.047|<|0.0001||95.0|0.16|0.345|||ANCOVA|||Olodaterol 2mcg - Placebo||0.345|0.160|<0.0001
72595176|NCT00824382|144721732|SUPERIORITY_OR_OTHER||Least Squares Mean for the difference|0.25|STANDARD_ERROR_OF_MEAN|0.047|<|0.0001||95.0|0.156|0.343|||ANCOVA|||Olodaterol 5mcg - Placebo||0.343|0.156|<0.0001
72595177|NCT00824382|144721732|SUPERIORITY_OR_OTHER||Least Squares Mean for the difference|0.233|STANDARD_ERROR_OF_MEAN|0.047|<|0.0001||95.0|0.141|0.325|||ANCOVA|||Olodaterol 10mcg - Placebo||0.325|0.141|<0.0001
72595178|NCT00824382|144721733|SUPERIORITY_OR_OTHER||Least Squares Mean for the difference|0.253|STANDARD_ERROR_OF_MEAN|0.05|<|0.0001||95.0|0.155|0.351|||ANCOVA|||Olodaterol 2mcg - Placebo||0.351|0.155|<0.0001
72595179|NCT00824382|144721733|SUPERIORITY_OR_OTHER||Least Squares Mean for the difference|0.242|STANDARD_ERROR_OF_MEAN|0.05|<|0.0001||95.0|0.142|0.341|||ANCOVA|||Olodaterol 5mcg - Placebo||0.341|0.142|<0.0001
72595180|NCT00824382|144721733|SUPERIORITY_OR_OTHER||Least Squares Mean for the difference|0.226|STANDARD_ERROR_OF_MEAN|0.05|<|0.0001||95.0|0.129|0.324|||ANCOVA|||Olodaterol 10mcg - Placebo||0.324|0.129|<0.0001
72595181|NCT00824382|144721734|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.111|STANDARD_ERROR_OF_MEAN|0.039||0.0045||95.0|0.035|0.188|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 2 mcg qd minus Placebo|||0.188|0.035|0.0045
72595182|NCT00824382|144721734|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.216|STANDARD_ERROR_OF_MEAN|0.039|<|0.0001||95.0|0.14|0.293|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 5 mcg qd minus Placebo|||0.293|0.140|<0.0001
72595183|NCT00824382|144721734|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.217|STANDARD_ERROR_OF_MEAN|0.038|<|0.0001||95.0|0.142|0.292|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 10 mcg qd minus Placebo|||0.292|0.142|<0.0001
72595184|NCT00824382|144721735|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.082|STANDARD_ERROR_OF_MEAN|0.039||0.0348||95.0|0.006|0.159|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 2 mcg qd minus Placebo|||0.159|0.006|0.0348
72595185|NCT00824382|144721735|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.176|STANDARD_ERROR_OF_MEAN|0.039|<|0.0001||95.0|0.1|0.252|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 5 mcg qd minus Placebo|||0.252|0.100|<0.0001
72595186|NCT00824382|144721735|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.19|STANDARD_ERROR_OF_MEAN|0.038|<|0.0001||95.0|0.115|0.265|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 10 mcg qd minus Placebo|||0.265|0.115|<0.0001
72595187|NCT00824382|144721736|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|27.256|STANDARD_ERROR_OF_MEAN|5.476|<|0.0001||95.0|16.477|38.036|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 2 mcg qd minus Placebo|||38.036|16.477|<0.0001
72595188|NCT00824382|144721736|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|29.383|STANDARD_ERROR_OF_MEAN|5.574|<|0.0001||95.0|18.41|40.357|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 5 mcg qd minus Placebo|||40.357|18.410|<0.0001
72595189|NCT00824382|144721736|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|36.678|STANDARD_ERROR_OF_MEAN|5.431|<|0.0001||95.0|25.987|47.369|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 10 mcg qd minus Placebo|||47.369|25.987|<0.0001
72595190|NCT00824382|144721737|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|29.052|STANDARD_ERROR_OF_MEAN|5.534|<|0.0001||95.0|18.159|39.946|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 2 mcg qd minus Placebo|||39.946|18.159|<0.0001
72595191|NCT00824382|144721737|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|30.955|STANDARD_ERROR_OF_MEAN|5.635|<|0.0001||95.0|19.861|42.049|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 5 mcg qd minus Placebo|||42.049|19.861|<0.0001
72595192|NCT00824382|144721737|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|37.191|STANDARD_ERROR_OF_MEAN|5.489|<|0.0001||95.0|26.386|47.996|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 10 mcg qd minus Placebo|||47.996|26.386|<0.0001
72595193|NCT00824382|144721738|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.191|STANDARD_ERROR_OF_MEAN|0.149||0.2016||95.0|-0.485|0.103|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 2 mcg qd minus Placebo|||0.103|-0.485|0.2016
72595194|NCT00824382|144721738|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.454|STANDARD_ERROR_OF_MEAN|0.151||0.0029||95.0|-0.752|-0.156|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 5 mcg qd minus Placebo|||-0.156|-0.752|0.0029
72595195|NCT00824382|144721738|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.387|STANDARD_ERROR_OF_MEAN|0.148||0.0095||95.0|-0.678|-0.095|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 10 mcg qd minus Placebo|||-0.095|-0.678|0.0095
72595196|NCT02407054|144721745|SUPERIORITY||Hazard Ratio (HR)|0.5871|||||TWO_SIDED|95.0|0.3967|0.869||||||||0.8690|0.3967|
72595197|NCT02407054|144721746|SUPERIORITY||Hazard Ratio (HR)|0.6515|||||TWO_SIDED|95.0|0.4123|1.0294||||||||1.0294|0.4123|
72595198|NCT02044874|144721757|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.02||||0.0027|TWO_SIDED|95.0|1.47|6.22|||Regression, Logistic|||||6.22|1.47|0.0027
72595199|NCT02044874|144721757|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.6||||0.2427|TWO_SIDED|95.0|0.73|3.51|||Regression, Logistic|||||3.51|0.73|0.2427
72595200|NCT02044874|144721757|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.89||||0.0477|TWO_SIDED|95.0|1.01|3.56|||Regression, Logistic|||||3.56|1.01|0.0477
72595201|NCT02044874|144721758|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.84||||0.0784|TWO_SIDED|95.0|0.89|9.08|||Regression, Logistic|||||9.08|0.89|0.0784
72595202|NCT02044874|144721758|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.78||||0.365|TWO_SIDED|95.0|0.51|6.17|||Regression, Logistic|||||6.17|0.51|0.3650
72595203|NCT02044874|144721758|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.6||||0.3438|TWO_SIDED|95.0|0.61|4.21|||Regression, Logistic|||||4.21|0.61|0.3438
72595204|NCT02044874|144721759|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.92||||0.0379|TWO_SIDED|95.0|1.04|3.55|||Regression, Logistic|||||3.55|1.04|0.0379
72595205|NCT02044874|144721759|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.06||||0.8628|TWO_SIDED|95.0|0.54|2.09|||Regression, Logistic|||||2.09|0.54|0.8628
72595206|NCT02044874|144721759|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.81||||0.0556|TWO_SIDED|95.0|0.99|3.31|||Regression, Logistic|||||3.31|0.99|0.0556
72595207|NCT02044874|144721760|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.92||||0.0219|TWO_SIDED|95.0|1.1|3.35|||Regression, Logistic|||||3.35|1.10|0.0219
72595208|NCT02044874|144721760|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.2||||0.545|TWO_SIDED|95.0|0.66|2.18|||Regression, Logistic|||||2.18|0.66|0.5450
72595209|NCT02044874|144721760|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.6||||0.0868|TWO_SIDED|95.0|0.93|2.72|||Regression, Logistic|||||2.72|0.93|0.0868
72595210|NCT02044874|144721761|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.97||||0.0004|TWO_SIDED|95.0|-1.51|-0.43|||Mixed-effects repeated measures|||||-0.43|-1.51|0.0004
72595211|NCT02044874|144721761|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.34||||0.2268|TWO_SIDED|95.0|-0.89|0.21|||mixed effects repeated measures|||||0.21|-0.89|0.2268
72595212|NCT02044874|144721761|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.63||||0.0217|TWO_SIDED|95.0|-1.17|-0.09|||mixed effects repeated measures|||||-0.09|-1.17|0.0217
72595213|NCT00415597|144721763|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||Null hypothesis: Percent change from baseline = 0||||<0.0001
72595214|NCT00415597|144721764|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||Null hypothesis: Percent change from baseline = 0||||<0.0001
72595215|NCT01447927|144721765|SUPERIORITY_OR_OTHER|||||||0.7981|||||||Wilcoxon Rank-Rum Test (1-sided)|||The null hypothesis was that the percent change in mean pS6K1 values (from pre to post) was the same or increased for the metformin arm as compared to placebo. Assuming equal standard deviations (i.e. 50%) across the metformin and placebo groups, 30 participants per arm yielded 84% power to detect at least a 35% decrease in the metformin arm as compared to placebo, using a 1-sided t-test with a significant level of 0.05.||||0.7981
72595216|NCT01650545|144721785|SUPERIORITY|||||||0.03|||||||Log Rank|||||||0.03
72595217|NCT00224406|144721818|SUPERIORITY||Mean Difference (Final Values)|5.022||||0.8541|ONE_SIDED|95.0||50.26|||t-test, 1 sided|||Repeated Measurements Analysis of PaO2/FiO2 ratio corrected for the altitude at 0 and 24hours after ICU admission using a one-sided test excluding missing data. Herein analysis at ICU Admission (Time 0).||50.26||0.8541
72595218|NCT00224406|144721818|SUPERIORITY||Mean Difference (Final Values)|10.426||||0.6996|ONE_SIDED|95.0||55.17|||t-test, 1 sided|||Repeated Measurements Analysis of PaO2/FiO2 ratio corrected for the altitude at 0 and 24hours after ICU admission using a one-sided test excluding missing data. Herein analysis at 24 Hours Post ICU Admission.||55.17||0.6996
72415121|NCT02207816|144340647|SUPERIORITY||Vaccine efficacy|53.68||||0.093|TWO_SIDED|95.0|-13.7|81.13|||Negative binomial regression|Mixed model without random effect \[Lievens, 2011\].||Vaccine efficacy (VE)/ incidence comparison against all episodes of severe malaria were estimated as 1-incidence ratio (IR; total number of events/follow-up time in the GSK257049 \[5-17M\] Group over the total number of events/follow-up time in the VeroRab Comparator \[5-17M\] Group).||81.13|-13.7|0.0930
72595219|NCT00224406|144721819|SUPERIORITY||Mean Difference (Final Values)|4.377||||0.8654|ONE_SIDED|95.0||47.15|||t-test, 1 sided|||ICU Admission (Time 0)||47.15||0.8654
72595220|NCT00224406|144721819|SUPERIORITY||Median Difference (Final Values)|13.386||||0.6789|ONE_SIDED|95.0||66.91|||t-test, 1 sided|||24 Hours Post ICU Admission||66.91||0.6789
72595221|NCT00224406|144721819|SUPERIORITY||Mean Difference (Final Values)|-19.968||||0.6345|ONE_SIDED|95.0||49.56|||t-test, 1 sided|||48 Hours Post ICU Admission||49.56||0.6345
72595222|NCT00224406|144721819|SUPERIORITY||Mean Difference (Final Values)|0.908||||0.9858|ONE_SIDED|95.0||85.49|||t-test, 1 sided|||72 Hours Post ICU Admission||85.49||0.9858
72595223|NCT00224406|144721820|SUPERIORITY||Odds Ratio (OR)|2.867||||0.7985|TWO_SIDED|95.0|0.727|11.302|||Cochran-Mantel-Haenszel||Odds ratio is Repertaxin:Placebo ratio of PGD scores 0-2:PGD score 3 odds|Analysis of PGD score was performed separately at time 0, and at 24, 48, 72 hours after ICU admission. Herein analysis at ICU Admission (Time 0). One patient of placebo group is excluded from analysis of PGD score because the cause of graft dysfunction is Cardiogenic pulmonary edema.||11.302|0.727|0.7985
72595224|NCT00224406|144721820|SUPERIORITY||Odds Ratio (OR)|0.837||||0.5606|TWO_SIDED|95.0|0.226|3.092|||Cochran-Mantel-Haenszel||Odds ratio is Repertaxin:Placebo ratio of PGD scores 0-2:PGD score 3 odds|Analysis of PGD score was performed separately at time 0, and at 24, 48, 72 hours after ICU admission. Herein analysis at 24h post-ICU admission. One patient of placebo group is excluded from analysis of PGD score because the cause of graft dysfunction is Cardiogenic pulmonary edema.||3.092|0.226|0.5606
72595225|NCT00224406|144721820|SUPERIORITY||Odds Ratio (OR)|1.716||||0.8786|TWO_SIDED|95.0|0.531|5.552|||Cochran-Mantel-Haenszel||Odds ratio is Repertaxin:Placebo ratio of PGD scores 0-2:PGD score 3 odds|Analysis of PGD score was performed separately at time 0, and at 24, 48, 72 hours after ICU admission. Herein analysis at 48h post-ICU admission. One patient of placebo group is excluded from analysis of PGD score because the cause of graft dysfunction is Cardiogenic pulmonary edema.||5.552|0.531|0.8786
72595226|NCT00224406|144721820|SUPERIORITY||Odds Ratio (OR)|1.337||||0.8499|TWO_SIDED|95.0|0.352|5.072|||Cochran-Mantel-Haenszel||Odds ratio is Repertaxin:Placebo ratio of PGD scores 0-2:PGD score 3 odds|Analysis of PGD score was performed separately at time 0, and at 24, 48, 72 hours after ICU admission. Herein analysis at 72h post-ICU admission. One patient of placebo group is excluded from analysis of PGD score because the cause of graft dysfunction is Cardiogenic pulmonary edema.||5.072|0.352|0.8499
72595227|NCT00224406|144721821|SUPERIORITY|at 24 hrs from mechanical ventilation|difference in event probability|0.0091||||0.7076|TWO_SIDED|95.0|-0.1867|0.2049|||Log Rank|||||0.2049|-0.1867|0.7076
72595228|NCT00224406|144721821|SUPERIORITY||difference in event probability|-0.0316||||0.7076|TWO_SIDED|95.0|-0.2092|0.146|||Log Rank|||at 48 hrs from mechanical ventilation||0.1460|-0.2092|0.7076
72595229|NCT00224406|144721821|SUPERIORITY||difference in event probability|-0.0661||||0.7076|TWO_SIDED|95.0|-0.2314|0.0993|||Log Rank|||at 72 hrs from mechanical ventilation||0.0993|-0.2314|0.7076
72595230|NCT00224406|144721822|SUPERIORITY||Difference in event probability|-0.0364||||0.9632|TWO_SIDED|95.0|-0.0858|0.0131|||Log Rank|||Analysis at 24 hours||0.0131|-0.0858|0.9632
72595231|NCT00224406|144721822|SUPERIORITY||Difference in event probability|0.0352||||0.9632|TWO_SIDED|95.0|-0.1458|0.2162|||Log Rank|||Analysis at 48 h||0.2162|-0.1458|0.9632
72595232|NCT00224406|144721822|SUPERIORITY||Difference in event probability|-0.0179||||0.9632|TWO_SIDED|95.0|-0.2143|0.1785|||Log Rank|||analysis at 72 h||0.1785|-0.2143|0.9632
72595233|NCT00224406|144721827|SUPERIORITY||Difference in event probability|-0.0566||||0.0111|TWO_SIDED|95.0|-0.1188|0.0056|||Log Rank|||Herein analysis up to month 3 was reported.||0.0056|-0.1188|0.0111
72595234|NCT00224406|144721827|SUPERIORITY||Difference in event probability|-0.0943||||0.0111|TWO_SIDED|95.0|-0.173|-0.0156|||Log Rank|||Herein analysis up to month 6 was reported.||-0.0156|-0.1730|0.0111
72595235|NCT00224406|144721827|SUPERIORITY||Difference in event probability|-0.1132||||0.0111|TWO_SIDED|95.0|-0.1985|-0.0279|||Log Rank|||Herein analysis up to month 9 was reported.||-0.0279|-0.1985|0.0111
72595236|NCT00224406|144721827|SUPERIORITY||Slope|-0.1334||||0.0111|TWO_SIDED|95.0|-0.2254|-0.0413|||Log Rank|||Herein analysis up to month 12 was reported.||-0.0413|-0.2254|0.0111
72595237|NCT01556997|144721830|SUPERIORITY_OR_OTHER|||||||0.025|ONE_SIDED|||||The statistical model was an analysis of covariance model with treatment as the main effect and baseline DBP (\<100 mmHg versus ≥100 mmHg), current type 2 diabetes status (yes versus no), and race (black versus non-black) as covariates.|ANCOVA|||||||0.025
72595238|NCT01556997|144721831|SUPERIORITY_OR_OTHER|||||||0.025|TWO_SIDED|||||The statistical model was an analysis of covariance model with treatment as the main effect and baseline DBP (\<100 mmHg versus ≥100 mmHg), current type 2 diabetes status (yes versus no), and race (black versus non-black) as covariates.|ANCOVA|||||||0.025
72595239|NCT01010009|144721834|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Data was analysed by omnibus ANOVA with a priori planned comparisons utilizing the mean squares error term from this ANOVA.||||>0.05
72595240|NCT01010009|144721834|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||Data was analysed by omnibus ANOVA with a priori planned comparisons utilizing the mean squares error term from this ANOVA.||||<0.05
72595241|NCT01010009|144721835|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Performance on each cognitive task was assessed via omnibus ANOVA with a priori planned comparisons.||||>0.05
72595242|NCT01010009|144721835|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Performance on each cognitive task was assessed via omnibus ANOVA with a priori planned comparisons.||||>0.05
72595243|NCT01010009|144721836|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||An omnibus ANOVA was carried out with a priori planned comparisons using the mean squares error term from this ANOVA.||||<0.05
72595244|NCT01010009|144721836|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||An omnibus ANOVA was carried out with a priori planned comparisons using the mean squares error term from this ANOVA.||||<0.05
72595245|NCT05459558|144721841|SUPERIORITY||||||<|0.0001||||||p-value adjusted for multiplicity using Graphical Approach.|Mixed Model with Repeated Measures|||Test for non-zero within group change from Baseline.||||<0.0001
72595246|NCT05459558|144721841|SUPERIORITY||||||<|0.0001||||||p-value adjusted for multiplicity using Graphical Approach.|Mixed Model with Repeated Measures|||Test for non-zero within group change from Baseline.||||<0.0001
72595247|NCT05459558|144721842|SUPERIORITY||||||<|0.0001|||||||Mixed Models with Repeated Measures|||Test for non-zero within group change from Baseline.||||<0.0001
72595248|NCT05459558|144721842|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Test for non-zero within group change from Baseline.||||<0.0001
72595249|NCT05459558|144721843|SUPERIORITY||Mean Difference (Final Values)|-1.75|STANDARD_ERROR_OF_MEAN|0.066|<|0.0001|TWO_SIDED|95.0|-1.88|-1.62|||Mixed Model with Repeated Measures|||Week 4||-1.62|-1.88|<0.0001
72595250|NCT05459558|144721843|SUPERIORITY||Mean Difference (Final Values)|-1.74|STANDARD_ERROR_OF_MEAN|0.066|<|0.0001|TWO_SIDED|95.0|-1.87|-1.61|||Mixed Model with Repeated Measures|||Week 4||-1.61|-1.87|<0.0001
72595251|NCT05459558|144721843|SUPERIORITY||Mean Difference (Final Values)|-1.95|STANDARD_ERROR_OF_MEAN|0.069|<|0.0001|TWO_SIDED|95.0|-2.08|-1.81||p-value adjusted for multiplicity using Graphical Approach.|Mixed Model with Repeated Measures|||Week 8||-1.81|-2.08|<0.0001
72595252|NCT05459558|144721843|SUPERIORITY||Mean Difference (Final Values)|-2.04|STANDARD_ERROR_OF_MEAN|0.069|<|0.0001|TWO_SIDED|95.0|-2.18|-1.9||p-value adjusted for multiplicity using Graphical Approach.|Mixed Model with Repeated Measures|||Week 8||-1.90|-2.18|<0.0001
72595253|NCT05459558|144721844|SUPERIORITY||Mean Difference (Final Values)|-0.81|STANDARD_ERROR_OF_MEAN|0.097|<|0.0001|TWO_SIDED|95.0|-1.0|-0.62|||Mixed Model with Repeated Measures|||Week 4||-0.62|-1.00|<0.0001
72595254|NCT05459558|144721844|SUPERIORITY||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.097|<|0.0001|TWO_SIDED|95.0|-0.79|-0.41|||Mixed Model with Repeated Measures|||Week 4||-0.41|-0.79|<0.0001
72595255|NCT05459558|144721844|SUPERIORITY||Mean Difference (Final Values)|-1.68|STANDARD_ERROR_OF_MEAN|0.19|<|0.0001|TWO_SIDED|95.0|-2.06|-1.31||p-value adjusted for multiplicity using Graphical Approach.|Mixed Model with Repeated Measures|||Week 8||-1.31|-2.06|<0.0001
72595256|NCT05459558|144721844|SUPERIORITY||Mean Difference (Final Values)|-1.81|STANDARD_ERROR_OF_MEAN|0.191|<|0.0001|TWO_SIDED|95.0|-2.19|-1.44||p-value adjusted for multiplicity using Graphical Approach.|Mixed Model with Repeated Measures|||Week 8||-1.44|-2.19|<0.0001
72595257|NCT05459558|144721845|SUPERIORITY||Mean Difference (Final Values)|-2.23|STANDARD_ERROR_OF_MEAN|0.092|<|0.0001|TWO_SIDED|95.0|-2.41|-2.05|||Mixed Model with Repeated Measures|||Gingival Sites, Week 4||-2.05|-2.41|<0.0001
72595258|NCT05459558|144721845|SUPERIORITY||Mean Difference (Final Values)|-2.23|STANDARD_ERROR_OF_MEAN|0.092|<|0.0001|TWO_SIDED|95.0|-2.41|-2.05|||Mixed Model with Repeated Measures|||Gingival Sites, Week 4||-2.05|-2.41|<0.0001
72595259|NCT05459558|144721845|SUPERIORITY||Mean Difference (Final Values)|-2.5|STANDARD_ERROR_OF_MEAN|0.095|<|0.0001|TWO_SIDED|95.0|-2.69|-2.31|||Mixed Model with Repeated Measures|||Gingival Sites, Week 8||-2.31|-2.69|<0.0001
72595260|NCT05459558|144721845|SUPERIORITY||Mean Difference (Final Values)|-2.63|STANDARD_ERROR_OF_MEAN|0.095|<|0.0001|TWO_SIDED|95.0|-2.81|-2.44|||Mixed Model with Repeated Measures|||Gingival Sites, Week 8||-2.44|-2.81|<0.0001
72595261|NCT05459558|144721845|SUPERIORITY||Mean Difference (Final Values)|-2.06|STANDARD_ERROR_OF_MEAN|0.079|<|0.0001|TWO_SIDED|95.0|-2.22|-1.91|||Mixed Model with Repeated Measures|||Interproximal Sites, Week 4||-1.91|-2.22|<0.0001
72595262|NCT05459558|144721845|SUPERIORITY||Mean Difference (Final Values)|-2.04|STANDARD_ERROR_OF_MEAN|0.079|<|0.0001|TWO_SIDED|95.0|-2.2|-1.89|||Mixed Model with Repeated Measures|||Interproximal Sites, Week 4||-1.89|-2.20|<0.0001
72595263|NCT05459558|144721845|SUPERIORITY||Mean Difference (Final Values)|-2.29|STANDARD_ERROR_OF_MEAN|0.081|<|0.0001|TWO_SIDED|95.0|-2.45|-2.13|||Mixed Model with Repeated Measures|||Interproximal Sites, Week 8||-2.13|-2.45|<0.0001
72595264|NCT05459558|144721845|SUPERIORITY||Mean Difference (Final Values)|-2.41|STANDARD_ERROR_OF_MEAN|0.082|<|0.0001|TWO_SIDED|95.0|-2.57|-2.25|||Mixed Model with Repeated Measures|||Interproximal Sites, Week 8||-2.25|-2.57|<0.0001
72595265|NCT05459558|144721845|SUPERIORITY||Mean Difference (Final Values)|-0.63|STANDARD_ERROR_OF_MEAN|0.066|<|0.0001|TWO_SIDED|95.0|-0.76|-0.5|||Mixed Model with Repeated Measures|||Body Sites, Week 4||-0.50|-0.76|<0.0001
72595266|NCT05459558|144721845|SUPERIORITY||Mean Difference (Final Values)|-0.64|STANDARD_ERROR_OF_MEAN|0.066|<|0.0001|TWO_SIDED|95.0|-0.77|-0.51|||Mixed Model with Repeated Measures|||Body Sites, Week 4||-0.51|-0.77|<0.0001
72415122|NCT02207816|144340647|SUPERIORITY||Vaccine efficacy|23.33||||0.5035|TWO_SIDED|95.0|-67.1|64.82|||Negative binomial regression|Mixed model without random effect \[Lievens, 2011\].||Vaccine efficacy (VE)/ incidence comparison against all episodes of severe malaria were estimated as 1-incidence ratio (IR; total number of events/follow-up time in the GSK257049 Comparator \[5-17M\] Group over the total number of events/follow-up time in the VeroRab Comparator \[5-17M\] Group).||64.82|-67.1|0.5035
72415123|NCT02207816|144340647|SUPERIORITY||Vaccine efficacy|32.08||||0.3504|TWO_SIDED|95.0|-53.1|69.87|||Negative binomial regression|Mixed model without random effect \[Lievens, 2011\].||Vaccine efficacy (VE)/ incidence comparison against all episodes of severe malaria were estimated as 1-incidence ratio (IR; total number of events/follow-up time in the GSK257049 \[6-12W\] Group over the total number of events/follow-up time in the Menjugate Comparator \[6-12W\] Group).||69.87|-53.1|0.3504
72415124|NCT02207816|144340647|SUPERIORITY||Vaccine efficacy|37.57||||0.2704|TWO_SIDED|95.0|-44.4|73.01|||Negative binomial regression|Mixed model without random effect \[Lievens, 2011\].||Vaccine efficacy (VE)/ incidence comparison against all episodes of severe malaria were estimated as 1-incidence ratio (IR; total number of events/follow-up time in the GSK257049 Comparator \[6-12W\] Group over the total number of events/follow-up time in the Menjugate Comparator \[6-12W\] Group).||73.01|-44.4|0.2704
72415125|NCT02207816|144340648|SUPERIORITY||Vaccine efficacy|-5.26||||0.4434|TWO_SIDED|95.0|-20.0|7.69|||Negative binomial regression|Mixed model with over-dispersion parameter estimated from the random effect \[Lievens, 2011\].||Vaccine efficacy (VE)/ incidence comparison against all episodes of clinical malaria were estimated as 1-incidence ratio (IR; total number of events/follow-up time in the GSK257049 \[5-17M\] Group over the total number of events/follow-up time in the VeroRab Comparator \[5-17M\] Group).||7.69|-20.0|0.4434
72415126|NCT02207816|144340648|SUPERIORITY||Vaccine efficacy|-8.1||||0.2634|TWO_SIDED|95.0|-23.9|5.7|||Negative binomial regression|Mixed model with over-dispersion parameter estimated from the random effect \[Lievens, 2011\].||Vaccine efficacy (VE)/incidence comparison against all episodes of clinical malaria were estimated as 1-incidence ratio (IR; total number of events/follow-up time in the GSK257049 Comparator \[5-17M\] Group over the total number of events/follow-up time in the VeroRab Comparator \[5-17M\] Group).||5.70|-23.9|0.2634
72415127|NCT02207816|144340648|SUPERIORITY||Vaccine efficacy|0.62||||0.9278|TWO_SIDED|95.0|-13.7|13.13|||Negative binomial regression|Mixed model with over-dispersion parameter estimated from the random effect \[Lievens, 2011\].||Vaccine efficacy (VE)/ incidence comparison against all episodes of clinical malaria were estimated as 1-incidence ratio (IR; total number of events/follow-up time in the GSK257049 \[6-12W\] Group over the total number of events/follow-up time in the Menjugate Comparator \[6-12W\] Group).||13.13|-13.7|0.9278
72415128|NCT02207816|144340648|SUPERIORITY||Vaccine efficacy|5.32||||0.4189|TWO_SIDED|95.0|-8.12|17.09|||Negative binomial regression|Mixed model with over-dispersion parameter estimated from the random effect \[Lievens, 2011\].||Vaccine efficacy (VE)/ incidence comparison against all episodes of clinical malaria were estimated as 1-incidence ratio (IR; total number of events/follow-up time in the GSK257049 Comparator \[6-12W\] Group over the total number of events/follow-up time in the Menjugate Comparator \[6-12W\] Group).||17.09|-8.12|0.4189
72415129|NCT02207816|144340649|SUPERIORITY||Vaccine efficacy|50.1||||0.1302|TWO_SIDED|95.0|-32.2|82.9|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) was estimated as 1-the risk ratio (RR; proportion of subjects reporting events in the GSK257049 \[5-17M\] Group over the proportion in VeroRab Comparator \[5-17M\] Group) over the entire follow-up period (from Year 0 to Year 3).||82.90|-32.2|0.1302
72595267|NCT05459558|144721845|SUPERIORITY||Mean Difference (Final Values)|-0.69|STANDARD_ERROR_OF_MEAN|0.061|<|0.0001|TWO_SIDED|95.0|-0.81|-0.57|||Mixed Model with Repeated Measures|||Body Sites, Week 8||-0.57|-0.81|<0.0001
72595268|NCT05459558|144721845|SUPERIORITY||Mean Difference (Final Values)|-0.69|STANDARD_ERROR_OF_MEAN|0.061|<|0.0001|TWO_SIDED|95.0|-0.81|-0.57|||Mixed Model with Repeated Measures|||Body Sites, Week 8||-0.57|-0.81|<0.0001
72595269|NCT05459558|144721846|SUPERIORITY||Mean Difference (Final Values)|-0.89|STANDARD_ERROR_OF_MEAN|0.039|<|0.0001|TWO_SIDED|95.0|-0.97|-0.82|||Mixed Model with Repeated Measures|||Area, Week 4||-0.82|-0.97|<0.0001
72595270|NCT05459558|144721846|SUPERIORITY||Mean Difference (Final Values)|-0.87|STANDARD_ERROR_OF_MEAN|0.039|<|0.0001|TWO_SIDED|95.0|-0.95|-0.79|||Mixed Model with Repeated Measures|||Area, Week 4||-0.79|-0.95|<0.0001
72595271|NCT05459558|144721846|SUPERIORITY||Mean Difference (Final Values)|-1.08|STANDARD_ERROR_OF_MEAN|0.037|<|0.0001|TWO_SIDED|95.0|-1.15|-1.01|||Mixed Model with Repeated Measures|||Area, Week 8||-1.01|-1.15|<0.0001
72595272|NCT05459558|144721846|SUPERIORITY||Mean Difference (Final Values)|-1.15|STANDARD_ERROR_OF_MEAN|0.037|<|0.0001|TWO_SIDED|95.0|-1.22|-1.07|||Mixed Model with Repeated Measures|||Area, Week 8||-1.07|-1.22|<0.0001
72595273|NCT05459558|144721846|SUPERIORITY||Mean Difference (Final Values)|-0.87|STANDARD_ERROR_OF_MEAN|0.033|<|0.0001|TWO_SIDED|95.0|-0.93|-0.8|||Mixed Model with Repeated Measures|||Intensity, Week 4||-0.80|-0.93|<0.0001
72595274|NCT05459558|144721846|SUPERIORITY||Mean Difference (Final Values)|-0.87|STANDARD_ERROR_OF_MEAN|0.033|<|0.0001|TWO_SIDED|95.0|-0.93|-0.8|||Mixed Model with Repeated Measures|||Intensity, Week 4||-0.80|-0.93|<0.0001
72595275|NCT05459558|144721846|SUPERIORITY||Mean Difference (Final Values)|-0.97|STANDARD_ERROR_OF_MEAN|0.035|<|0.0001|TWO_SIDED|95.0|-1.04|-0.9|||Mixed Model with Repeated Measures|||Intensity, Week 8||-0.90|-1.04|<0.0001
72595276|NCT05459558|144721846|SUPERIORITY||Mean Difference (Final Values)|-1.02|STANDARD_ERROR_OF_MEAN|0.035|<|0.0001|TWO_SIDED|95.0|-1.08|-0.95|||Mixed Model with Repeated Measures|||Intensity, Week 8||-0.95|-1.08|<0.0001
72595277|NCT03292458|144721854|SUPERIORITY|The primary efficacy outcome was analyzed using a restricted maximum likelihood (REML)-based linear mixed-effect model. The analysis included group, treatment, and treatment period as interacting fixed effects and subject as random effect. An unstructured covariance structure was used to model the within-patient errors.||||||0.01|TWO_SIDED|98.75|||||Mixed Models Analysis|||||||0.01
72595278|NCT03292458|144721855|OTHER|The minimum and average efficacy (in % symptom change) of sodium oxybate versus placebo in improving symptoms compared to the baseline was determined using binomial logistic regression.||||||0.05|TWO_SIDED|98.75|||||Regression, Logistic|||The minimum and average efficacy of sodium oxybate vs. placebo in improving symptoms compared to the baseline were determined using binomial logistic regression.||||0.05
72595279|NCT03292458|144721856|OTHER||Mean Difference (Final Values)|98.75||||0.01|TWO_SIDED||||||t-test, 2 sided|||||||0.01
72595280|NCT03292458|144721857|OTHER|||||||0.01|TWO_SIDED|98.75|||||ANOVA|||||||0.01
72595281|NCT03292458|144721858|OTHER|||||||0.01|TWO_SIDED|98.75|||||Pearson correlation|||||||0.01
72595282|NCT03292458|144721859|OTHER|||||||0.01|TWO_SIDED|98.75|||||Pearson correlation|||||||0.01
72595283|NCT04643964|144721955|SUPERIORITY|||||||0.54|||||||ANCOVA|||In this model, the condition included the following levels: entrée, sampler, and control. No covariates were included.||||.54
72415130|NCT02207816|144340649|SUPERIORITY||Vaccine efficacy|16.9||||0.6897|TWO_SIDED|95.0|-96.9|65.9|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) was estimated as 1-the risk ratio (RR; proportion of subjects reporting events in the GSK257049 Comparator \[5-17M\] Group over the proportion in VeroRab Comparator \[5-17M\] Group) over the entire follow-up period (from Year 0 to Year 3).||65.90|-96.9|0.6897
72415131|NCT02207816|144340649|SUPERIORITY||Vaccine efficacy|25.9||||0.5299|TWO_SIDED|95.0|-82.9|70.9|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) was estimated as 1-the risk ratio (RR; proportion of subjects reporting events in the GSK257049 \[6-12W\] Group over the proportion in Menjugate Comparator \[6-12W\] Group) over the entire follow-up period (from Year 0 to Year 3).||70.90|-82.9|0.5299
72415132|NCT02207816|144340649|SUPERIORITY||Vaccine efficacy|25.4||||0.5307|TWO_SIDED|95.0|-84.1|70.7|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) was estimated as 1-the risk ratio (RR; proportion of subjects reporting events in the GSK257049 Comparator \[6-12W\] Group over the proportion in Menjugate Comparator \[6-12W\] Group) over the entire follow-up period (from Year 0 to Year 3).||70.70|-84.1|0.5307
72415133|NCT02207816|144340650|SUPERIORITY||Vaccine efficacy|46.2||||0.1853|TWO_SIDED|95.0|-45.0|81.8|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) was estimated as 1-the risk ratio (RR; proportion of subjects reporting events in the GSK257049 \[5-17M\] Group over the proportion in VeroRab Comparator \[5-17M\] Group) over the entire follow-up period (from Year 0 to Year 3).||81.80|-45.0|0.1853
72415134|NCT02207816|144340650|SUPERIORITY||Vaccine efficacy|35.0||||0.3828|TWO_SIDED|95.0|-69.3|76.6|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) was estimated as 1-the risk ratio (RR; proportion of subjects reporting events in the GSK257049 Comparator \[5-17M\] Group over the proportion in VeroRab Comparator \[5-17M\] Group) over the entire follow-up period (from Year 0 to Year 3).||76.60|-69.3|0.3828
72415135|NCT02207816|144340650|SUPERIORITY||Vaccine efficacy|31.2||||0.4112|TWO_SIDED|95.0|-66.5|72.7|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) was estimated as 1-the risk ratio (RR; proportion of subjects reporting events in the GSK257049 \[6-12W\] Group over the proportion in Menjugate Comparator \[6-12W\] Group) over the entire follow-up period (from Year 0 to Year 3).||72.70|-66.5|0.4112
72415136|NCT02207816|144340650|SUPERIORITY||Vaccine efficacy|30.8||||0.4121|TWO_SIDED|95.0|-67.6|72.5|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) was estimated as 1-the risk ratio (RR; proportion of subjects reporting events in the GSK257049 Comparator \[6-12W\] Group over the proportion in Menjugate Comparator \[6-12W\] Group) over the entire follow-up period (from Year 0 to Year 3).||72.50|-67.6|0.4121
72415137|NCT02207816|144340651|SUPERIORITY||Vaccine efficacy|40.8|||<|0.0001|TWO_SIDED|95.0|15.7|58.8|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) against prevalent parasitemia assessed at Year 1 was estimated as 1-RR, where RR is the risk ratio (proportion of subjects reporting events in the GSK257049 \[5-17M\] Group over the proportion in VeroRab Comparator \[5-17M\] Group).||58.80|15.70|<0.0001
72415138|NCT02207816|144340651|SUPERIORITY||Vaccine effiicacy|42.7|||<|0.0001|TWO_SIDED|95.0|17.4|60.8|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) against prevalent parasitemia assessed at Year 1 was estimated as 1-RR, where RR is the risk ratio (proportion of subjects reporting events in the GSK257049 Comparator \[5-17M\] Group over the proportion in VeroRab Comparator \[5-17M\] Group).||60.80|17.40|<0.0001
72415139|NCT02207816|144340651|SUPERIORITY||Vaccine efficacy|16.0||||0.0883|TWO_SIDED|95.0|-6.6|33.9|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) against prevalent parasitemia assessed at Year 2 was estimated as 1-RR, where RR is the risk ratio (proportion of subjects reporting events in the GSK257049 \[5-17M\] Group over the proportion in VeroRab Comparator \[5-17M\] Group).||33.90|-6.60|0.0883
72415140|NCT02207816|144340651|SUPERIORITY||Vaccine efficacy|13.0||||0.1889|TWO_SIDED|95.0|-10.7|31.7|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) against prevalent parasitemia assessed at Year 2 was estimated as 1-RR, where RR is the risk ratio (proportion of subjects reporting events in the GSK257049 Comparator \[5-17M\] Group over the proportion in VeroRab Comparator \[5-17M\] Group).||31.70|-10.7|0.1889
72415141|NCT02207816|144340651|SUPERIORITY||Vaccine efficacy|16.4||||0.077|TWO_SIDED|95.0|-5.9|34.0|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) against prevalent parasitemia assessed at Year 3 was estimated as 1-RR, where RR is the risk ratio (proportion of subjects reporting events in the GSK257049 \[5-17M\] Group over the proportion in VeroRab Comparator \[5-17M\] Group).||34.00|-5.90|0.0770
72415142|NCT02207816|144340651|SUPERIORITY||Vaccine efficacy|0.1||||1|TWO_SIDED|95.0|-25.8|20.7|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) against prevalent parasitemia assessed at Year 3 was estimated as 1-RR, where RR is the risk ratio (proportion of subjects reporting events in the GSK257049 Comparator \[5-17M\] Group over the proportion in VeroRab Comparator \[5-17M\] Group).||20.70|-25.8|1.0000
72415143|NCT02207816|144340651|SUPERIORITY||Vaccine efficacy|20.8||||0.1624|TWO_SIDED|95.0|-17.5|46.9|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) against prevalent parasitemia assessed at Year 1 was estimated as 1-RR, where RR is the risk ratio (proportion of subjects reporting events in the GSK257049 \[6-12W\] Group over the proportion in Menjugate Comparator \[6-12W\] Group).||46.90|-17.5|0.1624
72415144|NCT02207816|144340651|SUPERIORITY||Vaccine efficacy|-2.3||||0.9112|TWO_SIDED|95.0|-47.6|29.0|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) against prevalent parasitemia assessed at Year 1 was estimated as 1-RR, where RR is the risk ratio (proportion of subjects reporting events in the GSK257049 Comparator \[6-12W\] Group over the proportion in Menjugate Comparator \[6-12W\] Group).||29.00|-47.6|0.9112
72415145|NCT02207816|144340651|SUPERIORITY||Vaccine efficacy|9.2||||0.4023|TWO_SIDED|95.0|-18.0|30.1|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) against prevalent parasitemia assessed at Year 2 was estimated as 1-RR, where RR is the risk ratio (proportion of subjects reporting events in the GSK257049 \[6-12W\] Group over the proportion in Menjugate Comparator \[6-12W\] Group).||30.10|-18.0|0.4023
72415146|NCT02207816|144340651|SUPERIORITY||Vaccine efficacy|-4.4||||0.7091|TWO_SIDED|95.0|-34.5|18.9|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) against prevalent parasitemia assessed at Year 2 was estimated as 1-RR, where RR is the risk ratio (proportion of subjects reporting events in the GSK257049 Comparator \[6-12W\] Group over the proportion in Menjugate Comparator \[6-12W\] Group).||18.90|-34.5|0.7091
72415147|NCT02207816|144340651|SUPERIORITY||Vaccine efficacy|-1.4||||0.9361|TWO_SIDED|95.0|-34.7|23.6|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) against prevalent parasitemia assessed at Year 3 was estimated as 1-RR, where RR is the risk ratio (proportion of subjects reporting events in the GSK257049 \[6-12W\] Group over the proportion in Menjugate Comparator \[6-12W\] Group).||23.60|-34.7|0.9361
72415148|NCT02207816|144340651|SUPERIORITY||Vaccine efficacy|-6.8||||0.628|TWO_SIDED|95.0|-42.0|19.6|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) against prevalent parasitemia assessed at Year 3 was estimated as 1-RR, where RR is the risk ratio (proportion of subjects reporting events in the GSK257049 Comparator \[6-12W\] Group over the proportion in Menjugate Comparator \[6-12W\] Group).||19.60|-42.0|0.6280
72415149|NCT02207816|144340652|SUPERIORITY||Vaccine efficacy|100.0||||0.4987|TWO_SIDED|95.0|-3779.0|100.0|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) against prevalent severe anemia assessed at Year 2 was estimated as 1-RR, where RR is the risk ratio (proportion of subjects reporting events in the GSK257049 \[5-17M\] Group over the proportion in VeroRab Comparator \[5-17M\] Group).||100.0|-3779|0.4987
72415150|NCT02207816|144340652|SUPERIORITY||Vaccine efficacy|100.0||||1|TWO_SIDED|95.0|-4051.0|100.0|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) against prevalent severe anemia assessed at Year 2 was estimated as 1-RR, where RR is the risk ratio (proportion of subjects reporting events in the GSK257049 Comparator \[5-17M\] Group over the proportion in VeroRab Comparator \[5-17M\] Group).||100.0|-4051|1.0000
72415151|NCT02207816|144340653|SUPERIORITY||Vaccine efficacy|-254.6||||0.1025|TWO_SIDED|95.0|-3399.0|32.5|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) against prevalent moderate anemia assessed at Year 1 was estimated as 1-RR, where RR is the risk ratio (proportion of subjects reporting events in the GSK257049 \[5-17M\] Group over the proportion in VeroRab Comparator \[5-17M\] Group).||32.50|-3399|0.1025
72415152|NCT02207816|144340653|SUPERIORITY||Vaccine efficacy|-398.6||||0.0284|TWO_SIDED|95.0|-4642.0|-3.2|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) against prevalent moderate anemia assessed at Year 1 was estimated as 1-RR, where RR is the risk ratio (proportion of subjects reporting events in the GSK257049 Comparator \[5-17M\] Group over the proportion in VeroRab Comparator \[5-17M\] Group).||-3.20|-4642|0.0284
72415153|NCT02207816|144340653|SUPERIORITY||Vaccine efficacy|36.7||||0.3543|TWO_SIDED|95.0|-78.8|79.2|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) against prevalent moderate anemia assessed at Year 2 was estimated as 1-RR, where RR is the risk ratio (proportion of subjects reporting events in the GSK257049 \[5-17M\] Group over the proportion in VeroRab Comparator \[5-17M\] Group).||79.20|-78.8|0.3543
72415154|NCT02207816|144340653|SUPERIORITY||Vaccine efficacy|3.2||||1|TWO_SIDED|95.0|-151.0|63.2|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) against prevalent moderate anemia assessed at Year 2 was estimated as 1-RR, where RR is the risk ratio (proportion of subjects reporting events in the GSK257049 Comparator \[5-17M\] Group over the proportion in VeroRab Comparator \[5-17M\] Group).||63.20|-151|1.0000
72415155|NCT02207816|144340653|SUPERIORITY||Vaccine efficacy|44.0||||0.3809|TWO_SIDED|95.0|-120.0|88.0|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) against prevalent moderate anemia assessed at Year 3 was estimated as 1-RR, where RR is the risk ratio (proportion of subjects reporting events in the GSK257049 \[5-17M\] Group over the proportion in VeroRab Comparator \[5-17M\] Group).||88.00|-120|0.3809
72415156|NCT02207816|144340653|SUPERIORITY||Vaccine efficacy|39.1||||0.549|TWO_SIDED|95.0|-140.0|86.9|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) against prevalent moderate anemia assessed at Year 3 was estimated as 1-RR, where RR is the risk ratio (proportion of subjects reporting events in the GSK257049 Comparator \[5-17M\] Group over the proportion in VeroRab Comparator \[5-17M\] Group).||86.90|-140|0.5490
72415157|NCT02207816|144340653|SUPERIORITY||Vaccine efficacy|-46.3||||0.3239|TWO_SIDED|95.0|-249.0|36.2|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) against prevalent moderate anemia assessed at Year 1 was estimated as 1-RR, where RR is the risk ratio (proportion of subjects reporting events in the GSK257049 \[6-12W\] Group over the proportion in Menjugate Comparator \[6-12W\] Group).||36.20|-249|0.3239
72415158|NCT02207816|144340653|SUPERIORITY||Vaccine efficacy|47.6||||0.2184|TWO_SIDED|95.0|-54.5|84.1|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) against prevalent moderate anemia assessed at Year 1 was estimated as 1-RR, where RR is the risk ratio (proportion of subjects reporting events in the GSK257049 Comparator \[6-12W\] Group over the proportion in Menjugate Comparator \[6-12W\] Group).||84.10|-54.5|0.2184
72415159|NCT02207816|144340653|SUPERIORITY||Vaccine efficacy|-116.8||||0.0724|TWO_SIDED|95.0|-476.0|10.3|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) against prevalent moderate anemia assessed at Year 2 was estimated as 1-RR, where RR is the risk ratio (proportion of subjects reporting events in the GSK257049 \[6-12W\] Group over the proportion in Menjugate Comparator \[6-12W\] Group).||10.30|-476|0.0724
72415160|NCT02207816|144340653|SUPERIORITY||Vaccine efficacy|-81.0||||0.2055|TWO_SIDED|95.0|-393.0|27.9|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) against prevalent moderate anemia assessed at Year 2 was estimated as 1-RR, where RR is the risk ratio (proportion of subjects reporting events in the GSK257049 Comparator \[6-12W\] Group over the proportion in Menjugate Comparator \[6-12W\] Group).||27.90|-393|0.2055
72595284|NCT04643964|144721956|SUPERIORITY|||||||0.92|||||||ANCOVA|||In this model, the condition included the following levels: entrée, sampler, and control. There was one covariate in this model: QIDS at Time 1.||||.92
72595285|NCT04643964|144721957|SUPERIORITY|||||||0.37|||||||ANCOVA|||In this model, the condition included the following levels: entrée, sampler, and control. There were three covariates in this model: QIDS at Time 1, gender, and COVID interference.||||.37
72595286|NCT04643964|144721958|SUPERIORITY|||||||0.87|||||||ANCOVA|||In this model, the condition included the following levels: entrée, sampler, and control. There was one covariate in this model: QIDS at Time 1.||||.87
72415161|NCT02207816|144340653|SUPERIORITY||Vaccine efficacy|-18.4||||0.8138|TWO_SIDED|95.0|-245.0|57.9|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) against prevalent moderate anemia assessed at Year 3 was estimated as 1-RR, where RR is the risk ratio (proportion of subjects reporting events in the GSK257049 \[6-12W\] Group over the proportion in Menjugate Comparator \[6-12W\] Group).||57.90|-245|0.8138
72415162|NCT02207816|144340653|SUPERIORITY||Vaccine efficacy|24.4||||0.7887|TWO_SIDED|95.0|-148.0|78.4|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) against prevalent moderate anemia assessed at Year 3 was estimated as 1-RR, where RR is the risk ratio (proportion of subjects reporting events in the GSK257049 Comparator \[6-12W\] Group over the proportion in Menjugate Comparator \[6-12W\] Group).||78.40|-148|0.7887
72595287|NCT01472939|144721982|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|6.06||||0.128|TWO_SIDED|95.0|-1.743|13.862|||Mixed Models Repeated Measures Analysis|||||13.862|-1.743|0.128
72595288|NCT01472939|144721982|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|7.42||||0.062|TWO_SIDED|95.0|-0.378|15.212|||Mixed Models Repeated Measures Analysis|||||15.212|-0.378|0.062
72595289|NCT01472939|144721982|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.83||||0.65|TWO_SIDED|95.0|-6.1|9.765|||Mixed Models Repeated Measures Analysis|||||9.765|-6.100|0.650
72595290|NCT01472939|144721983|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|6.75||||0.102|TWO_SIDED|95.0|-1.344|14.85|||Mixed Models Repeated Measures Analysis|||||14.850|-1.344|0.102
72595291|NCT01472939|144721983|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|8.92||||0.031|TWO_SIDED|95.0|0.814|17.021|||Mixed Models Repeated Measures Analysis|||||17.021|0.814|0.031
72595292|NCT01472939|144721983|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.71||||0.175|TWO_SIDED|95.0|-2.54|13.957|||Mixed Models Repeated Measures Analysis|||||13.957|-2.540|0.175
72595293|NCT01472939|144721984|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.47||||0.064|TWO_SIDED|95.0|-5.087|0.141|||Mixed Models Repeated Measures Analysis|||||0.141|-5.087|0.064
72595294|NCT01472939|144721984|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.2||||0.017|TWO_SIDED|95.0|-5.818|-0.573|||Mixed Models Repeated Measures Analysis|||||-0.573|-5.818|0.017
72595295|NCT01472939|144721984|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.15||||0.114|TWO_SIDED|95.0|-4.813|0.519|||Mixed Models Repeated Measures Analysis|||||0.519|-4.813|0.114
72595296|NCT05070468|144722006|SUPERIORITY|||||||0.618|||||||Wilcoxon (Mann-Whitney)|||||||0.618
72595297|NCT05070468|144722007|SUPERIORITY|||||||0.483|||||||Wilcoxon (Mann-Whitney)|||||||0.483
72595298|NCT05070468|144722008|SUPERIORITY|||||||0.571|||||||Wilcoxon (Mann-Whitney)|||||||0.571
72595299|NCT00308750|144722009|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4|||||||Log Rank|||||||0.40
72595300|NCT00308750|144722009|SUPERIORITY_OR_OTHER_LEGACY|||||||0.19|||||||Log Rank|||||||0.19
72595301|NCT00308750|144722013|SUPERIORITY_OR_OTHER_LEGACY|||||||0.96||||||P-value is for the change in Total FACT-L at Cycle 1 (Week 3).|ANCOVA|||||||0.96
72595302|NCT00308750|144722013|SUPERIORITY_OR_OTHER_LEGACY|||||||0.15||||||P-value is for the change in Total FACT-L at Cycle 1 (Week 3).|ANCOVA|||||||0.15
72595303|NCT00308750|144722013|SUPERIORITY_OR_OTHER_LEGACY|||||||0.92||||||P-value is for the change in Total FACT-L at Cycle 2 (Week 6).|ANCOVA|||||||0.92
72595304|NCT00308750|144722013|SUPERIORITY_OR_OTHER_LEGACY|||||||0.97||||||P-value is for the change in Total FACT-L at Cycle 2 (Week 6).|ANCOVA|||||||0.97
72595305|NCT00308750|144722013|SUPERIORITY_OR_OTHER_LEGACY|||||||0.71||||||P-value is for the change in Total FACT-L at Cycle 3 (Week 9).|ANCOVA|||||||0.71
72595306|NCT00308750|144722013|SUPERIORITY_OR_OTHER_LEGACY|||||||0.66||||||P-value is for the change in Total FACT-L at Cycle 3 (Week 9).|ANCOVA|||||||0.66
72595307|NCT00308750|144722013|SUPERIORITY_OR_OTHER_LEGACY|||||||0.93||||||P-value is for the change in Total FACT-L at Cycle 4 (Week 12).|ANCOVA|||||||0.93
72595308|NCT00308750|144722013|SUPERIORITY_OR_OTHER_LEGACY|||||||0.33||||||P-value is for the change in Total FACT-L at Cycle 4 (Week 12).|ANCOVA|||||||0.33
72595309|NCT00308750|144722013|SUPERIORITY_OR_OTHER_LEGACY|||||||0.19||||||P-value is for the change in Total FACT-L at Cycle 5 (Week 15).|ANCOVA|||||||0.19
72595310|NCT00308750|144722013|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4||||||P-value is for the change in Total FACT-L at Cycle 5 (Week 15).|ANCOVA|||||||0.40
72595311|NCT00308750|144722013|SUPERIORITY_OR_OTHER_LEGACY|||||||0.63||||||P-value is for the change in Total FACT-L at Cycle 6 (Week 18).|ANCOVA|||||||0.63
72595312|NCT00308750|144722013|SUPERIORITY_OR_OTHER_LEGACY|||||||0.55||||||P-value is for the change in Total FACT-L at Cycle 6 (Week 18).|ANCOVA|||||||0.55
72595313|NCT00308750|144722014|SUPERIORITY_OR_OTHER_LEGACY|||||||0.93||||||P-value is for the change in Total FACT-Taxane at Cycle 1 (Week 3).|ANCOVA|||||||0.93
72595314|NCT00308750|144722014|SUPERIORITY_OR_OTHER_LEGACY|||||||0.86||||||P-value is for the change in Total FACT-Taxane at Cycle 1 (Week 3).|ANCOVA|||||||0.86
72595315|NCT00308750|144722014|SUPERIORITY_OR_OTHER_LEGACY|||||||0.69||||||P-value is for the change in Total FACT-Taxane at Cycle 2 (Week 6).|ANCOVA|||||||0.69
72595316|NCT00308750|144722014|SUPERIORITY_OR_OTHER_LEGACY|||||||0.77||||||P-value is for the change in Total FACT-Taxane at Cycle 2 (Week 6).|ANCOVA|||||||0.77
72595317|NCT00308750|144722014|SUPERIORITY_OR_OTHER_LEGACY|||||||0.83||||||P-value is for the change in Total FACT-Taxane at Cycle 3 (Week 9).|ANCOVA|||||||0.83
72595318|NCT00308750|144722014|SUPERIORITY_OR_OTHER_LEGACY|||||||0.78||||||P-value is for the change in Total FACT-Taxane at Cycle 3 (Week 9).|ANCOVA|||||||0.78
72595319|NCT00308750|144722014|SUPERIORITY_OR_OTHER_LEGACY|||||||1||||||P-value is for the change in Total FACT-Taxane at Cycle 4 (Week 12).|ANCOVA|||||||1.00
72595320|NCT00308750|144722014|SUPERIORITY_OR_OTHER_LEGACY|||||||0.91||||||P-value is for the change in Total FACT-Taxane at Cycle 4 (Week 12).|ANCOVA|||||||0.91
72595321|NCT00308750|144722014|SUPERIORITY_OR_OTHER_LEGACY|||||||0.49||||||P-value is for the change in Total FACT-Taxane at Cycle 5 (Week 15).|ANCOVA|||||||0.49
72595322|NCT00308750|144722014|SUPERIORITY_OR_OTHER_LEGACY|||||||0.53||||||P-value is for the change in Total FACT-Taxane at Cycle 5 (Week 15).|ANCOVA|||||||0.53
72595323|NCT00308750|144722014|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8||||||P-value is for the change in Total FACT-Taxane at Cycle 6 (Week 18).|ANCOVA|||||||0.80
72595324|NCT00308750|144722014|SUPERIORITY_OR_OTHER_LEGACY|||||||0.85||||||P-value is for the change in Total FACT-Taxane at Cycle 6 (Week 18).|ANCOVA|||||||0.85
72595325|NCT00308750|144722015|SUPERIORITY_OR_OTHER_LEGACY|||||||0.87|||||||Log Rank|||||||0.87
72595326|NCT00308750|144722015|SUPERIORITY_OR_OTHER_LEGACY|||||||0.05|||||||Log Rank|||||||0.05
72595327|NCT00308750|144722018|SUPERIORITY_OR_OTHER_LEGACY|||||||0.71|||||||Log Rank|||||||0.71
72595328|NCT00308750|144722018|SUPERIORITY_OR_OTHER_LEGACY|||||||0.04|||||||Log Rank|||||||0.04
72595329|NCT00388297|144722029|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimate|0.0||||0.71|TWO_SIDED|95.0|-3.0|2.0|||Wilcoxon (Mann-Whitney)|||||2|-3|0.71
72595330|NCT00388297|144722029|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimate|-1.0||||0.3|TWO_SIDED|95.0|-4.0|1.0|||Wilcoxon (Mann-Whitney)|||||1|-4|0.30
72595331|NCT00388297|144722030|SUPERIORITY_OR_OTHER|||||||0.57|||||||Wilcoxon (Mann-Whitney)|||||||0.57
72595332|NCT00388297|144722030|SUPERIORITY_OR_OTHER|||||||0.46|||||||Wilcoxon (Mann-Whitney)|||||||0.46
72595333|NCT00388297|144722031|SUPERIORITY_OR_OTHER|||||||0.81|||||||Chi-squared|||Analysis for \< 34 weeks||||0.81
72595334|NCT00388297|144722031|SUPERIORITY_OR_OTHER|||||||0.47|||||||Chi-squared|||Analysis for \<34 weeks||||0.47
72595335|NCT00388297|144722031|SUPERIORITY_OR_OTHER|||||||0.44|||||||Chi-squared|||Analysis for \<37 weeks||||0.44
72595336|NCT00388297|144722031|SUPERIORITY_OR_OTHER|||||||0.11|||||||Chi-squared|||Analysis for \< 37 weeks||||0.11
72595337|NCT00388297|144722031|SUPERIORITY_OR_OTHER||Hodges-Lehmann|0.0||||0.31|TWO_SIDED|95.0|0.0|3.0|||Chi-squared|||Bayley-III Motor (24 months)||3|0|0.31
72595338|NCT00388297|144722031|SUPERIORITY_OR_OTHER||Hodges-Lehmann|0.0||||0.3|TWO_SIDED|95.0|0.0|3.0|||Chi-squared|||Bayley-II Language (24 months)||3|0|0.30
72595339|NCT00388297|144722031|SUPERIORITY_OR_OTHER||Hodges-Lehmann|0.0||||0.89|TWO_SIDED|95.0|0.0|0.0|||Chi-squared|||Bayley-III Cognitive (12 months)||0|0|0.89
72595340|NCT00388297|144722031|SUPERIORITY_OR_OTHER||Hodges-Lehmann|0.0||||0.54|TWO_SIDED|95.0|0.0|3.0|||Chi-squared|||Bayley-III Motor (12 months)||3|0|0.54
72595341|NCT00388297|144722031|SUPERIORITY_OR_OTHER||Hodges-Lehmann|0.0||||0.92|TWO_SIDED|95.0|-3.0|3.0|||Chi-squared|||Bayley-III Language (12 months)||3|-3|0.92
72595342|NCT00388297|144722031|SUPERIORITY_OR_OTHER||Hodges-Lehmann|0.0||||0.7|TWO_SIDED|95.0|0.0|0.0|||Chi-squared|||Bayley-III Cognitive (24 months)||0|0|0.70
72595343|NCT00388297|144722031|SUPERIORITY_OR_OTHER||Hodges-Lehmann|0.0||||0.2|TWO_SIDED|95.0|-3.0|0.0|||Chi-squared|||Bayley-III Motor (24 months)||0|-3|0.20
72595344|NCT00388297|144722031|SUPERIORITY_OR_OTHER||Hodges-Lehmann|0.0||||0.71|TWO_SIDED|95.0|-3.0|2.0|||Chi-squared|||Bayley-II Language (24 months)||2|-3|0.71
72595345|NCT00388297|144722032|SUPERIORITY_OR_OTHER||Hodges-Lehmann|0.0||||0.89|TWO_SIDED|95.0|-3.0|2.0|||Chi-squared|||||2|-3|0.89
72595346|NCT00388297|144722032|SUPERIORITY_OR_OTHER||Hodges-Lehmann|-1.0||||0.48|TWO_SIDED|95.0|-3.0|2.0|||Chi-squared|||||2|-3|0.48
72595347|NCT00388297|144722033|SUPERIORITY_OR_OTHER||Hodges-Lehmann|0.0||||0.9|TWO_SIDED|95.0|-2.0|3.0|||Chi-squared|||||3|-2|0.90
72595348|NCT00388297|144722033|SUPERIORITY_OR_OTHER||Hodges-Lehmann|-1.0||||0.64|TWO_SIDED|95.0|-3.0|2.0|||Chi-squared|||||2|-3|0.64
72595349|NCT00388297|144722034|SUPERIORITY_OR_OTHER||Hodges-Lehmann|0.0||||0.6|TWO_SIDED|95.0|-5.0|7.0|||Chi-squared|||Analysis for recall of digits forward||7|-5|0.60
72595350|NCT00388297|144722034|SUPERIORITY_OR_OTHER||Hodges-Lehmann|0.0||||0.22|TWO_SIDED|95.0|-8.0|0.0|||Chi-squared|||Analysis for recall of digits forward||0|-8|0.22
72595351|NCT00388297|144722034|SUPERIORITY_OR_OTHER||Hodges-Lehmann|0.0||||0.52|TWO_SIDED|95.0|-6.0|0.0|||Chi-squared|||Analysis for Recognition of Pictures||0|-6|0.52
72415163|NCT02207816|144340654|SUPERIORITY||Vaccine efficacy|40.5||||0.0077|TWO_SIDED|95.0|12.84|59.39|||Negative binomial regression|Mixed model without random effect \[Lievens, 2011\].||Vaccine efficacy (VE)/incidence comparison against all episodes of severe malaria were estimated as 1-incidence ratio (IR; total number of events/follow-up time in the GSK257049 \[5-17M\] Group over the total number of events/follow-up time in the VeroRab Comparator \[5-17M\] Group).||59.39|12.84|0.0077
72415164|NCT02207816|144340654|SUPERIORITY||Vaccine efficacy|-4.52||||0.7922|TWO_SIDED|95.0|-45.3|24.8|||Negative binomial regression|Mixed model without random effect \[Lievens, 2011\].||Vaccine efficacy (VE)/incidence comparison against all episodes of severe malaria were estimated as 1-incidence ratio (IR; total number of events/follow-up time in the GSK257049 Comparator \[5-17M\] Group over the total number of events/follow-up time in the VeroRab Comparator \[5-17M\] Group).||24.80|-45.3|0.7922
72595352|NCT00388297|144722034|SUPERIORITY_OR_OTHER||Hodges-Lehmann|0.0||||0.91|TWO_SIDED|95.0|-4.0|0.0|||Chi-squared|||Analysis for Recognition of Pictures||0|-4|0.91
72595353|NCT00388297|144722035|SUPERIORITY_OR_OTHER||Hodges-Lehmann|0.0||||0.63|TWO_SIDED|95.0|0.0|0.0|||Chi-squared|||Bayley II Cognitive (12 months)||0|0|0.63
72595354|NCT00388297|144722035|SUPERIORITY_OR_OTHER||Hodges-Lehmann|0.0||||0.83|TWO_SIDED|95.0|0.0|3.0|||Chi-squared|||Bayley II Motor (12 mo)||3|0|0.83
72595355|NCT00388297|144722035|SUPERIORITY_OR_OTHER||Hodges-Lehmann|0.0||||0.48|TWO_SIDED|95.0|0.0|3.0|||Chi-squared|||Bayley-III Language (12 months)||3|0|0.48
72415165|NCT02207816|144340654|SUPERIORITY||Vaccine efficacy|29.03||||0.0802|TWO_SIDED|95.0|-4.22|51.67|||Negative binomial regression|Mixed model without random effect \[Lievens, 2011\].||Vaccine efficacy (VE)/incidence comparison against all episodes of severe malaria were estimated as 1-incidence ratio (IR; total number of events/follow-up time in the GSK257049 \[6-12W\] Group over the total number of events/follow-up time in the Menjugate Comparator \[6-12W\] Group).||51.67|-4.22|0.0802
72415166|NCT02207816|144340654|SUPERIORITY||Vaccine efficacy|33.87||||0.0387|TWO_SIDED|95.0|2.13|55.32|||Negative binomial regression|Mixed model without random effect \[Lievens, 2011\].||Vaccine efficacy (VE)/incidence comparison against all episodes of severe malaria were estimated as 1-incidence ratio (IR; total number of events/follow-up time in the GSK257049 Comparator \[6-12W\] Group over the total number of events/follow-up time in the Menjugate Comparator \[6-12W\] Group).||55.32|2.13|0.0387
72415167|NCT02207816|144340655|SUPERIORITY||Vaccine efficacy|36.69||||0.0028|TWO_SIDED|95.0|14.6|53.07|||Negative binomial regression|Mixed model without random effect \[Lievens, 2011\].||Vaccine efficacy (VE)/incidence comparison against all episodes of severe malaria were estimated as 1-incidence ratio (IR; total number of events/follow-up time in the GSK257049 \[5-17M\] Group over the total number of events/follow-up time in the VeroRab Comparator \[5-17M\] Group).||53.07|14.60|0.0028
72415168|NCT02207816|144340655|SUPERIORITY||Vaccine efficacy|10.14||||0.443|TWO_SIDED|95.0|-18.1|31.64|||Negative binomial regression|Mixed model without random effect \[Lievens, 2011\].||Vaccine efficacy (VE)/incidence comparison against all episodes of severe malaria were estimated as 1-incidence ratio (IR; total number of events/follow-up time in the GSK257049 Comparator \[5-17M\] Group over the total number of events/follow-up time in the VeroRab Comparator \[5-17M\] Group).||31.64|-18.1|0.4430
72415169|NCT02207816|144340655|SUPERIORITY||Vaccine efficacy|30.99||||0.0245|TWO_SIDED|95.0|4.67|50.04|||Negative binomial regression|Mixed model without random effect \[Lievens, 2011\].||Vaccine efficacy (VE)/incidence comparison against all episodes of severe malaria were estimated as 1-incidence ratio (IR; total number of events/follow-up time in the GSK257049 \[6-12W\] Group over the total number of events/follow-up time in the Menjugate Comparator \[6-12W\] Group).||50.04|4.67|0.0245
72415170|NCT02207816|144340655|SUPERIORITY||Vaccine efficacy|34.24||||0.0122|TWO_SIDED|95.0|8.74|52.61|||Negative binomial regression|Mixed model without random effect \[Lievens, 2011\].||Vaccine efficacy (VE)/incidence comparison against all episodes of severe malaria were estimated as 1-incidence ratio (IR; total number of events/follow-up time in the GSK257049 Comparator \[6-12W\] Group over the total number of events/follow-up time in the Menjugate Comparator \[6-12W\] Group).||52.61|8.74|0.0122
72595356|NCT00388297|144722035|SUPERIORITY_OR_OTHER||Hodges-Lehmann|0.0||||0.59|TWO_SIDED|95.0|0.0|0.0|||Chi-squared|||Bayley-III Cognitive (24 months)||0|0|0.59
72595357|NCT00388297|144722036|SUPERIORITY_OR_OTHER||Hodges-Lehmann|0.0||||0.99|TWO_SIDED|95.0|-2.0|2.0|||Chi-squared|||CBCL at 36 months||2|-2|0.99
72595358|NCT00388297|144722036|SUPERIORITY_OR_OTHER||Hodges-Lehmann|0.0||||0.96|TWO_SIDED|95.0|-2.0|2.0|||Chi-squared|||CBCL at 60 months||2|-2|0.96
72595359|NCT00388297|144722036|SUPERIORITY_OR_OTHER||Hodges-Lehmann|0.0||||0.65|TWO_SIDED|95.0|-2.0|2.0|||Chi-squared|||CBCL at 36 months||2|-2|0.65
72595360|NCT00388297|144722036|SUPERIORITY_OR_OTHER||Hodges-Lehmann|-1.0||||0.44|TWO_SIDED|95.0|-3.0|1.0|||Chi-squared|||CBCL at 60 months||1|-3|0.44
72595361|NCT00388297|144722037|SUPERIORITY_OR_OTHER||Hodges-Lehmann|0.0||||0.37|TWO_SIDED|95.0|-1.0|2.0|||Chi-squared|||||2|-1|0.37
72595362|NCT00388297|144722037|SUPERIORITY_OR_OTHER||Hodges-Lehmann|0.0||||0.98|TWO_SIDED|95.0|-2.0|2.0|||Chi-squared|||||2|-2|0.98
72595363|NCT00388297|144722038|SUPERIORITY_OR_OTHER|||||||0.12|||||||Chi-squared|||||||0.12
72595364|NCT00388297|144722038|SUPERIORITY_OR_OTHER|||||||1|||||||Chi-squared|||||||1.00
72595365|NCT00388297|144722039|SUPERIORITY_OR_OTHER|||||||0.69|||||||Chi-squared|||||||0.69
72595366|NCT00388297|144722039|SUPERIORITY_OR_OTHER|||||||0.51|||||||Chi-squared|||||||0.51
72595367|NCT00388297|144722040|SUPERIORITY_OR_OTHER|||||||0.76|||||||Chi-squared|||||||0.76
72415171|NCT02207816|144340656|SUPERIORITY||Vaccine efficacy|23.67|||<|0.0001|TWO_SIDED|95.0|15.93|30.71|||Negative binomial regression|Mixed model with over-dispersion parameter estimated from the random effect \[Lievens, 2011\].||Vaccine efficacy (VE)/incidence comparison against all episodes of clinical malaria were estimated as 1-incidence ratio (IR; total number of events/follow-up time in the GSK257049 \[5-17M\] Group over the total number of events/follow-up time in the VeroRab Comparator \[5-17M\] Group).||30.71|15.93|<.0001
72595368|NCT00388297|144722040|SUPERIORITY_OR_OTHER|||||||0.64|||||||Chi-squared|||||||0.64
72595369|NCT00388297|144722041|SUPERIORITY_OR_OTHER|||||||0.66|||||||Chi-squared|||||||0.66
72595370|NCT00388297|144722041|SUPERIORITY_OR_OTHER|||||||0.62|||||||Chi-squared|||||||0.62
72595371|NCT00388297|144722042|SUPERIORITY_OR_OTHER|||||||0.24|||||||Chi-squared|||||||0.24
72595372|NCT00388297|144722042|SUPERIORITY_OR_OTHER|||||||0.55|||||||Chi-squared|||||||0.55
72595373|NCT00388297|144722043|SUPERIORITY_OR_OTHER|||||||0.36|||||||Chi-squared|||||||0.36
72595374|NCT00388297|144722043|SUPERIORITY_OR_OTHER|||||||0.28|||||||Chi-squared|||||||0.28
72595375|NCT00388297|144722044|SUPERIORITY_OR_OTHER|||||||0.5|||||||Chi-squared|||||||0.50
72595376|NCT00388297|144722044|SUPERIORITY_OR_OTHER|||||||1|||||||Chi-squared|||||||1.00
72595377|NCT00388297|144722045|SUPERIORITY_OR_OTHER|||||||0.76|||||||Chi-squared|||Apgar at 1 min \< 4||||0.76
72595378|NCT00388297|144722045|SUPERIORITY_OR_OTHER|||||||0.76|||||||Chi-squared|||Apgar \> 4 at 1 minute||||0.76
72595379|NCT00388297|144722045|SUPERIORITY_OR_OTHER|||||||0.69|||||||Chi-squared|||Apgar \< 7 at 5 minutes||||0.69
72595380|NCT00388297|144722045|SUPERIORITY_OR_OTHER|||||||0.45|||||||Chi-squared|||Apgar \< 7 at 5 minutes||||0.45
72595381|NCT00388297|144722046|SUPERIORITY_OR_OTHER|||||||0.24|||||||Chi-squared|||||||0.24
72595382|NCT00388297|144722046|SUPERIORITY_OR_OTHER|||||||0.97|||||||Chi-squared|||||||0.97
72595383|NCT00388297|144722047|SUPERIORITY_OR_OTHER|||||||0.45|||||||Chi-squared|||||||0.45
72595384|NCT00388297|144722047|SUPERIORITY_OR_OTHER|||||||0.68|||||||Chi-squared|||||||0.68
72595385|NCT00388297|144722048|SUPERIORITY_OR_OTHER|||||||0.46|||||||Wilcoxon (Mann-Whitney)|||||||0.46
72595386|NCT00388297|144722048|SUPERIORITY_OR_OTHER|||||||0.19|||||||Wilcoxon (Mann-Whitney)|||||||0.19
72595387|NCT00388297|144722049|SUPERIORITY_OR_OTHER|||||||0.45|||||||Chi-squared|||||||0.45
72595388|NCT00388297|144722049|SUPERIORITY_OR_OTHER|||||||0.75|||||||Chi-squared|||||||0.75
72595389|NCT00388297|144722050|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||||||1.00
72595390|NCT00388297|144722051|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||||||1.00
72595391|NCT00388297|144722051|SUPERIORITY_OR_OTHER|||||||0.5|||||||Fisher Exact|||||||0.50
72595392|NCT00388297|144722052|SUPERIORITY_OR_OTHER|||||||0.5|||||||Fisher Exact|||||||0.50
72595393|NCT00388297|144722052|SUPERIORITY_OR_OTHER|||||||0.49|||||||Fisher Exact|||||||0.49
72595394|NCT00388297|144722053|SUPERIORITY_OR_OTHER|||||||0.99|||||||Chi-squared|||||||0.99
72595395|NCT00388297|144722053|SUPERIORITY_OR_OTHER|||||||0.85|||||||Chi-squared|||||||0.85
72595396|NCT00388297|144722054|SUPERIORITY_OR_OTHER|||||||0.43|||||||Wilcoxon (Mann-Whitney)|||||||0.43
72595397|NCT00388297|144722054|SUPERIORITY_OR_OTHER|||||||0.39|||||||Wilcoxon (Mann-Whitney)|||||||0.39
72595398|NCT02607280|144722055|OTHER||LS mean change from baseline at Week 14|-1.79|||||TWO_SIDED|95.0|-2.45|-1.14||||||||-1.14|-2.45|
72595399|NCT02607280|144722055|OTHER||LS mean change from baseline at Week 14|-2.07|||||TWO_SIDED|95.0|-3.77|-0.36||||||||-0.36|-3.77|
72595400|NCT00577005|144722056|SUPERIORITY_OR_OTHER||Slope|-0.05425|STANDARD_ERROR_OF_MEAN|0.03211||0.09|TWO_SIDED|||||p-value \<0.05 considered statistically significant|Mixed Models Analysis|We modeled the the change in thrice weekly cocaine urines using a mixed-effect ordinal regression approach with MIXOR.|Group x time interaction: Z=-1.68950 p = 0.09112|||||0.09
72595401|NCT00577005|144722057|SUPERIORITY_OR_OTHER||Slope|0.0257|STANDARD_ERROR_OF_MEAN|0.04369||0.55|TWO_SIDED|||||p-value \<0.05 considered statistically significant|Mixed Models Analysis|We modeled the the change in thrice weekly opioid urines using a mixed-effect ordinal regression approach with MIXOR.|Group x time interaction: Z= 0.58823 p = 0.55638|||||0.55
72595402|NCT00577005|144722058|SUPERIORITY_OR_OTHER|||||||0.67||||||p-value \<0.05 considered statistically significant|Log Rank|Chi-Square 0.175. df = 1, p=0.676||||||0.67
72595403|NCT00577005|144722059|SUPERIORITY_OR_OTHER||Slope|-0.1557||||0.11|TWO_SIDED|||||Significant p-value \< 0.05|Mixed Models Analysis||Interaction of time x group: Z = -1.5671, p = 0.11708|||||0.11
72595404|NCT01004432|144722060|SUPERIORITY_OR_OTHER||Percentage achive ACR 20 response|34.9|||<|0.0001|TWO_SIDED|95.0|30.4|39.4||One sided test adjusting for conducting one interim analysis|Chi-squared|||null hypothesis: proportion \<=0.2||39.4|30.4|<0.0001
72595405|NCT02696434|144722104|SUPERIORITY||Odds Ratio (OR)|0.68||||0.407|TWO_SIDED|95.0|0.28|1.68|||Regression, Logistic|||||1.68|0.28|0.407
72595406|NCT02539134|144722115|SUPERIORITY_OR_OTHER||Slope|1.06||||0.757|TWO_SIDED|90.0|0.741|1.374|||Power model|||Day 1: For groups with QD dosing, dose proportionality for TAK-935 plasma exposure on Day 1 was assessed using the power model. For Day 1, the criteria for dose proportionality was the 90 percent (%) confidence interval (CI) for the slope within (0.875, 1.125) for the dose range of 100 mg to 600 mg.||1.374|0.741|0.757
72595407|NCT02539134|144722115|SUPERIORITY_OR_OTHER||Slope|1.37||||0.042|TWO_SIDED|90.0|1.078|1.664|||Power model|||Day 14: For groups with QD dosing, dose proportionality for TAK-935 plasma exposure on Day 14 was assessed using the power model. For Day 14, the criteria for dose proportionality was the 90% CI for the slope within (0.839, 1.161) for the dose range of 100 mg to 400 mg.||1.664|1.078|0.042
72595408|NCT02539134|144722116|SUPERIORITY_OR_OTHER||Slope|1.2||||0.191|TWO_SIDED|90.0|0.946|1.45|||Power model|||Day 1: For groups with QD dosing, dose proportionality for TAK-935 plasma exposure on Day 1 was assessed using the power model. For Day 1, the criteria for dose proportionality was the 90% CI for the slope within (0.875, 1.125) for the dose range of 100 mg to 600 mg.||1.450|0.946|0.191
72595409|NCT02539134|144722116|SUPERIORITY_OR_OTHER||Slope|1.37||||0.036|TWO_SIDED|90.0|1.089|1.657|||Power model|||Day 14: For groups with QD dosing, dose proportionality for TAK-935 plasma exposure on Day 14 was assessed using the power model. For Day 14, the criteria for dose proportionality was the 90% CI for the slope within (0.839, 1.161) for the dose range of 100 mg to 400 mg.||1.657|1.089|0.036
72595410|NCT02539134|144722117|SUPERIORITY_OR_OTHER||Slope|1.19||||0.288|TWO_SIDED|90.0|0.89|1.489|||Power model|||Day 1: For groups with QD dosing, dose proportionality for TAK-935 plasma exposure on Day 1 was assessed using the power model. For Day 1, the criteria for dose proportionality was the 90% CI for the slope within (0.875, 1.125) for the dose range of 100 mg to 600 mg.||1.489|0.890|0.288
72595411|NCT02539134|144722118|SUPERIORITY_OR_OTHER||Slope|1.36||||0.039|TWO_SIDED|90.0|1.08|1.642|||Power model|||Day 14: For groups with QD dosing, dose proportionality for TAK-935 plasma exposure on Day 14 was assessed using the power model. For Day 14, the criteria for dose proportionality was the 90% CI for the slope within (0.839, 1.161) for the dose range of 100 mg to 400 mg.||1.642|1.080|0.039
72595412|NCT04526574|144722199|NON_INFERIORITY|Noninferiority (NI) for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR of the (SIIV+20vPnC)/saline group to the (SIIV+saline)/20vPnC group was greater than 0.5 (2-fold criterion) for that serotype.|Geometric Mean Ratio (GMR)|0.74|||||TWO_SIDED|95.0|0.65|0.84||||||Serotype 1: GMR (ratio of GMTs \[SIIV+20vPnC\]/saline to \[SIIV+saline\]/20vPnC) and 95% CIs were calculated by exponentiating the difference of least square (LS) means for OPA titers and corresponding CIs based on regression model adjusted with vaccine group, sex, smoking status, age at Vaccination 1 in years, baseline log-transformed OPA titers, and prior pneumococcal vaccination status.||0.84|0.65|
72595413|NCT04526574|144722199|NON_INFERIORITY|NI for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR of the (SIIV+20vPnC)/saline group to the (SIIV+saline)/20vPnC group was greater than 0.5 (2-fold criterion) for that serotype.|GMR|0.82|||||TWO_SIDED|95.0|0.75|0.9||||||Serotype 3: GMR (ratio of GMTs \[SIIV+20vPnC\]/saline to \[SIIV+saline\]/20vPnC) and 95% CIs were calculated by exponentiating the difference of LS means for OPA titers and corresponding CIs based on regression model adjusted with vaccine group, sex, smoking status, age at Vaccination 1 in years, baseline log-transformed OPA titers, and prior pneumococcal vaccination status.||0.90|0.75|
72595414|NCT04526574|144722199|NON_INFERIORITY|NI for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR of the (SIIV+20vPnC)/saline group to the (SIIV+saline)/20vPnC group was greater than 0.5 (2-fold criterion) for that serotype.|GMR|0.89|||||TWO_SIDED|95.0|0.77|1.02||||||Serotype 4: GMR (ratio of GMTs \[SIIV+20vPnC\]/saline to \[SIIV+saline\]/20vPnC) and 95% CIs were calculated by exponentiating the difference of LS means for OPA titers and corresponding CIs based on regression model adjusted with vaccine group, sex, smoking status, age at Vaccination 1 in years, baseline log-transformed OPA titers, and prior pneumococcal vaccination status.||1.02|0.77|
72595415|NCT04526574|144722199|NON_INFERIORITY|NI for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR of the (SIIV+20vPnC)/saline group to the (SIIV+saline)/20vPnC group was greater than 0.5 (2-fold criterion) for that serotype.|GMR|0.88|||||TWO_SIDED|95.0|0.79|0.98||||||Serotype 5: GMR (ratio of GMTs \[SIIV+20vPnC\]/saline to \[SIIV+saline\]/20vPnC) and 95% CIs were calculated by exponentiating the difference of LS means for OPA titers and corresponding CIs based on regression model adjusted with vaccine group, sex, smoking status, age at Vaccination 1 in years, baseline log-transformed OPA titers, and prior pneumococcal vaccination status.||0.98|0.79|
72595416|NCT04526574|144722199|NON_INFERIORITY|NI for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR of the (SIIV+20vPnC)/saline group to the (SIIV+saline)/20vPnC group was greater than 0.5 (2-fold criterion) for that serotype.|GMR|0.76|||||TWO_SIDED|95.0|0.65|0.88||||||Serotype 6A: GMR (ratio of GMTs \[SIIV+20vPnC\]/saline to \[SIIV+saline\]/20vPnC) and 95% CIs were calculated by exponentiating the difference of LS means for OPA titers and corresponding CIs based on regression model adjusted with vaccine group, sex, smoking status, age at Vaccination 1 in years, baseline log-transformed OPA titers, and prior pneumococcal vaccination status.||0.88|0.65|
72595417|NCT04526574|144722199|NON_INFERIORITY|NI for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR of the (SIIV+20vPnC)/saline group to the (SIIV+saline)/20vPnC group was greater than 0.5 (2-fold criterion) for that serotype.|GMR|0.81|||||TWO_SIDED|95.0|0.71|0.94||||||Serotype 6B: GMR (ratio of GMTs \[SIIV+20vPnC\]/saline to \[SIIV+saline\]/20vPnC) and 95% CIs were calculated by exponentiating the difference of LS means for OPA titers and corresponding CIs based on regression model adjusted with vaccine group, sex, smoking status, age at Vaccination 1 in years, baseline log-transformed OPA titers, and prior pneumococcal vaccination status.||0.94|0.71|
72595418|NCT04526574|144722199|NON_INFERIORITY|NI for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR of the (SIIV+20vPnC)/saline group to the (SIIV+saline)/20vPnC group was greater than 0.5 (2-fold criterion) for that serotype.|GMR|0.9|||||TWO_SIDED|95.0|0.83|0.99||||||Serotype 7F: GMR (ratio of GMTs \[SIIV+20vPnC\]/saline to \[SIIV+saline\]/20vPnC) and 95% CIs were calculated by exponentiating the difference of LS means for OPA titers and corresponding CIs based on regression model adjusted with vaccine group, sex, smoking status, age at Vaccination 1 in years, baseline log-transformed OPA titers, and prior pneumococcal vaccination status.||0.99|0.83|
72595419|NCT04526574|144722199|NON_INFERIORITY|NI for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR of the (SIIV+20vPnC)/saline group to the (SIIV+saline)/20vPnC group was greater than 0.5 (2-fold criterion) for that serotype.|GMR|0.8|||||TWO_SIDED|95.0|0.7|0.93||||||Serotype 8: GMR (ratio of GMTs \[SIIV+20vPnC\]/saline to \[SIIV+saline\]/20vPnC) and 95% CIs were calculated by exponentiating the difference of LS means for OPA titers and corresponding CIs based on regression model adjusted with vaccine group, sex, smoking status, age at Vaccination 1 in years, baseline log-transformed OPA titers, and prior pneumococcal vaccination status.||0.93|0.70|
72595420|NCT04526574|144722199|NON_INFERIORITY|NI for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR of the (SIIV+20vPnC)/saline group to the (SIIV+saline)/20vPnC group was greater than 0.5 (2-fold criterion) for that serotype.|GMR|0.94|||||TWO_SIDED|95.0|0.82|1.07||||||Serotype 9V: GMR (ratio of GMTs \[SIIV+20vPnC\]/saline to \[SIIV+saline\]/20vPnC) and 95% CIs were calculated by exponentiating the difference of LS means for OPA titers and corresponding CIs based on regression model adjusted with vaccine group, sex, smoking status, age at Vaccination 1 in years, baseline log-transformed OPA titers, and prior pneumococcal vaccination status.||1.07|0.82|
72595421|NCT04526574|144722199|NON_INFERIORITY|NI for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR of the (SIIV+20vPnC)/saline group to the (SIIV+saline)/20vPnC group was greater than 0.5 (2-fold criterion) for that serotype.|GMR|0.83|||||TWO_SIDED|95.0|0.71|0.96||||||Serotype 10A: GMR (ratio of GMTs \[SIIV+20vPnC\]/saline to \[SIIV+saline\]/20vPnC) and 95% CIs were calculated by exponentiating the difference of LS means for OPA titers and corresponding CIs based on regression model adjusted with vaccine group, sex, smoking status, age at Vaccination 1 in years, baseline log-transformed OPA titers, and prior pneumococcal vaccination status.||0.96|0.71|
72595422|NCT04526574|144722199|NON_INFERIORITY|NI for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR of the (SIIV+20vPnC)/saline group to the (SIIV+saline)/20vPnC group was greater than 0.5 (2-fold criterion) for that serotype.|GMR|0.71|||||TWO_SIDED|95.0|0.6|0.84||||||Serotype 11A: GMR (ratio of GMTs \[SIIV+20vPnC\]/saline to \[SIIV+saline\]/20vPnC) and 95% CIs were calculated by exponentiating the difference of LS means for OPA titers and corresponding CIs based on regression model adjusted with vaccine group, sex, smoking status, age at Vaccination 1 in years, baseline log-transformed OPA titers, and prior pneumococcal vaccination status.||0.84|0.60|
72595423|NCT04526574|144722199|NON_INFERIORITY|NI for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR of the (SIIV+20vPnC)/saline group to the (SIIV+saline)/20vPnC group was greater than 0.5 (2-fold criterion) for that serotype.|GMR|0.82|||||TWO_SIDED|95.0|0.69|0.97||||||Serotype 12F: GMR (ratio of GMTs \[SIIV+20vPnC\]/saline to \[SIIV+saline\]/20vPnC) and 95% CIs were calculated by exponentiating the difference of LS means for OPA titers and corresponding CIs based on regression model adjusted with vaccine group, sex, smoking status, age at Vaccination 1 in years, baseline log-transformed OPA titers, and prior pneumococcal vaccination status.||0.97|0.69|
72595424|NCT04526574|144722199|NON_INFERIORITY|NI for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR of the (SIIV+20vPnC)/saline group to the (SIIV+saline)/20vPnC group was greater than 0.5 (2-fold criterion) for that serotype.|GMR|0.86|||||TWO_SIDED|95.0|0.76|0.96||||||Serotype 14: GMR (ratio of GMTs \[SIIV+20vPnC\]/saline to \[SIIV+saline\]/20vPnC) and 95% CIs were calculated by exponentiating the difference of LS means for OPA titers and corresponding CIs based on regression model adjusted with vaccine group, sex, smoking status, age at Vaccination 1 in years, baseline log-transformed OPA titers, and prior pneumococcal vaccination status.||0.96|0.76|
72595425|NCT04526574|144722199|NON_INFERIORITY|NI for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR of the (SIIV+20vPnC)/saline group to the (SIIV+saline)/20vPnC group was greater than 0.5 (2-fold criterion) for that serotype.|GMR|0.7|||||TWO_SIDED|95.0|0.57|0.86||||||Serotype 15B: GMR (ratio of GMTs \[SIIV+20vPnC\]/saline to \[SIIV+saline\]/20vPnC) and 95% CIs were calculated by exponentiating the difference of LS means for OPA titers and corresponding CIs based on regression model adjusted with vaccine group, sex, smoking status, age at Vaccination 1 in years, baseline log-transformed OPA titers, and prior pneumococcal vaccination status.||0.86|0.57|
72595426|NCT04526574|144722199|NON_INFERIORITY|NI for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR of the (SIIV+20vPnC)/saline group to the (SIIV+saline)/20vPnC group was greater than 0.5 (2-fold criterion) for that serotype.|GMR|0.9|||||TWO_SIDED|95.0|0.77|1.04||||||Serotype 18C: GMR (ratio of GMTs \[SIIV+20vPnC\]/saline to \[SIIV+saline\]/20vPnC) and 95% CIs were calculated by exponentiating the difference of LS means for OPA titers and corresponding CIs based on regression model adjusted with vaccine group, sex, smoking status, age at Vaccination 1 in years, baseline log-transformed OPA titers, and prior pneumococcal vaccination status.||1.04|0.77|
72595427|NCT04526574|144722199|NON_INFERIORITY|NI for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR of the (SIIV+20vPnC)/saline group to the (SIIV+saline)/20vPnC group was greater than 0.5 (2-fold criterion) for that serotype.|GMR|0.88|||||TWO_SIDED|95.0|0.78|0.98||||||Serotype 19A: GMR (ratio of GMTs \[SIIV+20vPnC\]/saline to \[SIIV+saline\]/20vPnC) and 95% CIs were calculated by exponentiating the difference of LS means for OPA titers and corresponding CIs based on regression model adjusted with vaccine group, sex, smoking status, age at Vaccination 1 in years, baseline log-transformed OPA titers, and prior pneumococcal vaccination status.||0.98|0.78|
72595428|NCT04526574|144722199|NON_INFERIORITY|NI for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR of the (SIIV+20vPnC)/saline group to the (SIIV+saline)/20vPnC group was greater than 0.5 (2-fold criterion) for that serotype.|GMR|0.89|||||TWO_SIDED|95.0|0.78|1.01||||||Serotype 19F: GMR (ratio of GMTs \[SIIV+20vPnC\]/saline to \[SIIV+saline\]/20vPnC) and 95% CIs were calculated by exponentiating the difference of LS means for OPA titers and corresponding CIs based on regression model adjusted with vaccine group, sex, smoking status, age at Vaccination 1 in years, baseline log-transformed OPA titers, and prior pneumococcal vaccination status.||1.01|0.78|
72595429|NCT04526574|144722199|NON_INFERIORITY|NI for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR of the (SIIV+20vPnC)/saline group to the (SIIV+saline)/20vPnC group was greater than 0.5 (2-fold criterion) for that serotype.|GMR|0.75|||||TWO_SIDED|95.0|0.62|0.9||||||Serotype 22F: GMR (ratio of GMTs \[SIIV+20vPnC\]/saline to \[SIIV+saline\]/20vPnC) and 95% CIs were calculated by exponentiating the difference of LS means for OPA titers and corresponding CIs based on regression model adjusted with vaccine group, sex, smoking status, age at Vaccination 1 in years, baseline log-transformed OPA titers, and prior pneumococcal vaccination status.||0.90|0.62|
72595430|NCT04526574|144722199|NON_INFERIORITY|NI for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR of the (SIIV+20vPnC)/saline group to the (SIIV+saline)/20vPnC group was greater than 0.5 (2-fold criterion) for that serotype.|GMR|0.78|||||TWO_SIDED|95.0|0.66|0.92||||||Serotype 23F: GMR (ratio of GMTs \[SIIV+20vPnC\]/saline to \[SIIV+saline\]/20vPnC) and 95% CIs were calculated by exponentiating the difference of LS means for OPA titers and corresponding CIs based on regression model adjusted with vaccine group, sex, smoking status, age at Vaccination 1 in years, baseline log-transformed OPA titers, and prior pneumococcal vaccination status.||0.92|0.66|
72595431|NCT04526574|144722199|NON_INFERIORITY|NI for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR of the (SIIV+20vPnC)/saline group to the (SIIV+saline)/20vPnC group was greater than 0.5 (2-fold criterion) for that serotype.|GMR|0.72|||||TWO_SIDED|95.0|0.62|0.83||||||Serotype 33F: GMR (ratio of GMTs \[SIIV+20vPnC\]/saline to \[SIIV+saline\]/20vPnC) and 95% CIs were calculated by exponentiating the difference of LS means for OPA titers and corresponding CIs based on regression model adjusted with vaccine group, sex, smoking status, age at Vaccination 1 in years, baseline log-transformed OPA titers, and prior pneumococcal vaccination status.||0.83|0.62|
72595432|NCT04526574|144722200|NON_INFERIORITY|NI was declared if the lower bound of the 2-sided 95% CI for the GMR of the (SIIV+20vPnC)/saline group to the (SIIV+saline)/20vPnC group was greater than 0.67 (1.5-fold criterion).|GMR|1.07|||||TWO_SIDED|95.0|0.97|1.17||||||A/H1N1: GMRs (ratio of GMTs \[SIIV+20vPnC\]/saline to \[SIIV+saline\]/20vPnC) and 2-sided CIs were calculated by exponentiating the difference of LS means for the HAI titers and the corresponding CIs based on the regression model adjusted with vaccine group, sex, smoking status, age at Vaccination 1 in years, baseline log-transformed HAI titers, and prior pneumococcal vaccination status.||1.17|0.97|
72595433|NCT04526574|144722200|NON_INFERIORITY|NI was declared if the lower bound of the 2-sided 95% CI for the GMR of the (SIIV+20vPnC)/saline group to the (SIIV+saline)/20vPnC group was greater than 0.67 (1.5-fold criterion).|GMR|0.98|||||TWO_SIDED|95.0|0.89|1.08||||||A/H3N2: GMRs (ratio of GMTs \[SIIV+20vPnC\]/saline to \[SIIV+saline\]/20vPnC) and 2-sided CIs were calculated by exponentiating the difference of LS means for the HAI titers and the corresponding CIs based on the regression model adjusted with vaccine group, sex, smoking status, age at Vaccination 1 in years, baseline log-transformed HAI titers, and prior pneumococcal vaccination status.||1.08|0.89|
72595434|NCT04526574|144722200|NON_INFERIORITY|NI was declared if the lower bound of the 2-sided 95% CI for the GMR of the (SIIV+20vPnC)/saline group to the (SIIV+saline)/20vPnC group was greater than 0.67 (1.5-fold criterion).|GMR|1.0|||||TWO_SIDED|95.0|0.93|1.08||||||B/Victoria: GMRs (ratio of GMTs \[SIIV+20vPnC\]/saline to \[SIIV+saline\]/20vPnC) and 2-sided CIs were calculated by exponentiating the difference of LS means for the HAI titers and the corresponding CIs based on the regression model adjusted with vaccine group, sex, smoking status, age at Vaccination 1 in years, baseline log-transformed HAI titers, and prior pneumococcal vaccination status.||1.08|0.93|
72595435|NCT04526574|144722200|NON_INFERIORITY|NI was declared if the lower bound of the 2-sided 95% CI for the GMR of the (SIIV+20vPnC)/saline group to the (SIIV+saline)/20vPnC group was greater than 0.67 (1.5-fold criterion).|GMR|0.95|||||TWO_SIDED|95.0|0.87|1.03||||||B/Phuket: GMRs (ratio of GMTs \[SIIV+20vPnC\]/saline to \[SIIV+saline\]/20vPnC) and 2-sided CIs were calculated by exponentiating the difference of LS means for the HAI titers and the corresponding CIs based on the regression model adjusted with vaccine group, sex, smoking status, age at Vaccination 1 in years, baseline log-transformed HAI titers, and prior pneumococcal vaccination status.||1.03|0.87|
72595436|NCT00424021|144722210|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.5|STANDARD_DEVIATION|46.93|||TWO_SIDED|95.0|-8.3|17.3||||||The small sample size, nonrandomized dose group assignments, and the potential for dose adjustments precluded meaningful comparisons between the dose groups. Therefore, efficacy results are only presented for the combined ambrisentan group.||17.3|-8.3|
72595437|NCT00424021|144722211|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-10.3|STANDARD_DEVIATION|73.16|||TWO_SIDED|95.0|-30.3|9.7||||||The small sample size, nonrandomized dose group assignments, and the potential for dose adjustments precluded meaningful comparisons between the dose groups. Therefore, efficacy results are only presented for the combined ambrisentan group.||9.7|-30.3|
72595438|NCT00424021|144722212|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.7|STANDARD_DEVIATION|83.08|||TWO_SIDED|95.0|-27.4|18.0||||||The small sample size, nonrandomized dose group assignments, and the potential for dose adjustments precluded meaningful comparisons between the dose groups. Therefore, efficacy results are only presented for the combined ambrisentan group.||18.0|-27.4|
72595439|NCT00424021|144722213|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-13.9|STANDARD_DEVIATION|77.04|||TWO_SIDED|95.0|-34.9|7.1||||||The small sample size, nonrandomized dose group assignments, and the potential for dose adjustments precluded meaningful comparisons between the dose groups. Therefore, efficacy results are only presented for the combined ambrisentan group.||7.1|-34.9|
72595440|NCT00424021|144722215|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.21|STANDARD_DEVIATION|1.323|||TWO_SIDED|95.0|-0.15|0.57||||||The small sample size, nonrandomized dose group assignments, and the potential for dose adjustments precluded meaningful comparisons between the dose groups. Therefore, efficacy results are only presented for the combined ambrisentan group.||0.57|-0.15|
72595441|NCT00424021|144722216|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.46|STANDARD_DEVIATION|1.659|||TWO_SIDED|95.0|0.01|0.92||||||The small sample size, nonrandomized dose group assignments, and the potential for dose adjustments precluded meaningful comparisons between the dose groups. Therefore, efficacy results are only presented for the combined ambrisentan group.||0.92|0.01|
72595442|NCT00424021|144722217|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.5|STANDARD_DEVIATION|1.888|||TWO_SIDED|95.0|-0.02|1.02||||||The small sample size, nonrandomized dose group assignments, and the potential for dose adjustments precluded meaningful comparisons between the dose groups. Therefore, efficacy results are only presented for the combined ambrisentan group.||1.02|-0.02|
72595443|NCT00424021|144722218|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.46|STANDARD_DEVIATION|1.721|||TWO_SIDED|95.0|-0.01|0.93||||||The small sample size, nonrandomized dose group assignments, and the potential for dose adjustments precluded meaningful comparisons between the dose groups. Therefore, efficacy results are only presented for the combined ambrisentan group.||0.93|-0.01|
72595444|NCT00424021|144722225|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.6|STANDARD_DEVIATION|19.41|||TWO_SIDED|95.0|-5.9|4.7||||||The small sample size, nonrandomized dose group assignments, and the potential for dose adjustments precluded meaningful comparisons between the dose groups. Therefore, efficacy results are only presented for the combined ambrisentan group.||4.7|-5.9|
72595445|NCT00424021|144722226|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-7.4|STANDARD_DEVIATION|25.79|||TWO_SIDED|95.0|-14.4|-0.3||||||The small sample size, nonrandomized dose group assignments, and the potential for dose adjustments precluded meaningful comparisons between the dose groups. Therefore, efficacy results are only presented for the combined ambrisentan group.||-0.3|-14.4|
72595446|NCT00424021|144722227|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.1|STANDARD_DEVIATION|25.31|||TWO_SIDED|95.0|-12.0|1.8||||||The small sample size, nonrandomized dose group assignments, and the potential for dose adjustments precluded meaningful comparisons between the dose groups. Therefore, efficacy results are only presented for the combined ambrisentan group.||1.8|-12.0|
72595447|NCT00424021|144722228|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.9|STANDARD_DEVIATION|23.69|||TWO_SIDED|95.0|-8.4|4.6||||||The small sample size, nonrandomized dose group assignments, and the potential for dose adjustments precluded meaningful comparisons between the dose groups. Therefore, efficacy results are only presented for the combined ambrisentan group.||4.6|-8.4|
72595448|NCT04877535|144722300|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.524|TWO_SIDED|95.0|-0.24|0.12|||t-test, 2 sided|||||0.12|-0.24|0.524
72595449|NCT04877535|144722300|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.403|TWO_SIDED|95.0|-0.4|0.16|||t-test, 2 sided|||||0.16|-0.4|0.403
72595450|NCT04877535|144722301|SUPERIORITY||Odds Ratio (OR)|1.05||||1|TWO_SIDED|95.0|0.47|2.38|||Fisher Exact|||||2.38|0.47|1.00
72595451|NCT04877535|144722302|SUPERIORITY||Odds Ratio (OR)|4.3|||<|0.001|TWO_SIDED|95.0|1.81|11.13|||Fisher Exact|||||11.13|1.81|<0.001
72595452|NCT04877535|144722302|SUPERIORITY||Odds Ratio (OR)|1.08||||1|TWO_SIDED|95.0|0.23|4.19|||Fisher Exact|||||4.19|0.23|1.00
72595453|NCT04877535|144722303|SUPERIORITY||Odds Ratio (OR)|7.1|||<|0.001|TWO_SIDED|95.0|1.94|39.25|||Fisher Exact|||||39.25|1.94|<0.001
72595454|NCT04877535|144722303|SUPERIORITY||Odds Ratio (OR)|1.63||||0.63|TWO_SIDED|95.0|0.13|14.86|||Fisher Exact|||||14.86|0.13|0.630
72595455|NCT05079230|144722336|SUPERIORITY||Hazard Ratio (HR)|1.178||||0.3276|TWO_SIDED|95.0|0.848|1.637|||stratified log-rank test|The 2-sided P-value was based on stratified log-rank test, stratified by stratification factors at randomization.|Stratified hazard ratio (HR) and its 95% CI were calculated using the stratified cox proportional hazards model.|||1.637|0.848|0.3276
72595456|NCT05079230|144722337|SUPERIORITY||Stratified Odds Ratio|0.826||||0.3616|TWO_SIDED|95.0|0.545|1.251|||Stratum-adjusted Mantel-Haenszel||Stratified odds ratio and 2-sided 95% CI were calculated from stratum-adjusted Mantel-Haenszel estimates adjusted for stratification factors.|||1.251|0.545|0.3616
72595457|NCT05079230|144722338|SUPERIORITY||Stratified Odds Ratio|0.856||||0.4679|TWO_SIDED|95.0|0.56|1.307|||Stratum-adjusted Mantel-Haenszel||Stratified odds ratio and 2-sided 95% CI were calculated from stratum-adjusted Mantel-Haenszel estimates adjusted for stratification factors.|||1.307|0.560|0.4679
72595458|NCT05079230|144722339|SUPERIORITY||Stratified Hazard Ratio|0.946||||0.7903|TWO_SIDED|95.0|0.73|1.225|||Stratified Log Rank||The 2-sided P-value was based on stratified log-rank test, stratified by stratification factors at randomization.|||1.225|0.730|0.7903
72595459|NCT05079230|144722342|SUPERIORITY||Stratified Odds Ratio|1.189||||0.4873|TWO_SIDED|95.0|0.727|1.945|||Stratum-adjusted Mantel Haenszel||Stratified odds ratio and 2-sided 95% CI were calculated from stratum-adjusted Mantel-Haenszel estimates adjusted for stratification factors.|||1.945|0.727|0.4873
72595460|NCT05079230|144722343|SUPERIORITY||Stratified Odds Ratio|1.154||||0.5842|TWO_SIDED|95.0|0.69|1.932|||Stratum-adjusted Mantel Haenszel||Stratified odds ratio and 2-sided 95% CI were calculated from stratum-adjusted Mantel-Haenszel estimates adjusted for stratification factors.|||1.932|0.690|0.5842
72595461|NCT05079230|144722344|SUPERIORITY||Stratified Odds Ratio|0.783||||0.3003|TWO_SIDED|95.0|0.492|1.245|||Cochran-Mantel-Haenszel||The 2-sided P-value was based on Cochran-Mantel-Haenszel (CMH) method stratified by the stratification factors at randomization (age, genetic risk group, and geographic region).|||1.245|0.492|0.3003
72595462|NCT05079230|144722345|SUPERIORITY||Stratified Odds Ratio|1.21||||0.579|TWO_SIDED|95.0|0.62|2.36||The 2-sided P-value was based on Cochran-Mantel-Haenszel (CMH) method stratified by the stratification factors at randomization (age, genetic risk group, and geographic region).|Cochran-Mantel-Haenszel|||||2.360|0.620|0.5790
72595463|NCT05079230|144722346|SUPERIORITY||Stratified Hazard Ratio|1.09||||0.5796|TWO_SIDED|95.0|0.799|1.487|||Stratified Log Rank|The 2-sided P-value was based on stratified log-rank test, stratified by stratification factors at randomization.|Stratified hazard ratio (HR) and its 95% CI are calculated using the stratified cox proportional hazards model.|||1.487|0.799|0.5796
72595464|NCT05079230|144722347|SUPERIORITY||Stratified Hazard Ratio|1.271||||0.1026|TWO_SIDED|95.0|0.948|1.704|||Stratified Log Rank|The 2-sided P-value was based on stratified log-rank test, stratified by stratification factors at randomization.|Stratified hazard ratio (HR) and its 95% CI were calculated using the stratified cox proportional hazards model.|||1.704|0.948|0.1026
72595465|NCT01524783|144722353|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.48|||<|0.001|TWO_SIDED|95.0|0.35|0.67|||Log Rank|||||0.67|0.35|<0.001
72595466|NCT01524783|144722354|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.9||||0.259|TWO_SIDED|95.0|0.66|1.24|||Log Rank|||||1.24|0.66|0.259
72595467|NCT01524783|144722357|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.74||||0.073|TWO_SIDED|95.0|0.5|1.1|||Log Rank|||||1.10|0.50|0.073
72595468|NCT01524783|144722360|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.02||||0.539|TWO_SIDED|95.0|0.65|1.61|||Log Rank|||||1.61|0.65|0.539
72595469|NCT01362244|144722387|SUPERIORITY_OR_OTHER_LEGACY|||||||0.003||95.0|||||Fisher Exact|||Statistical data is presented for NR||||0.003
72595470|NCT01362244|144722387|SUPERIORITY_OR_OTHER_LEGACY|||||||0.016||95.0|||||Fisher Exact|||Statistical data is presented for LOCF||||0.016
72595471|NCT01362244|144722388|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.74||||0.71|TWO_SIDED|95.0|0.15|3.64|||Regression, Logistic||Week 1|||3.64|0.15|0.710
72595472|NCT01362244|144722388|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.4||||0.674|TWO_SIDED|95.0|0.29|6.87|||Regression, Logistic||Week 2|||6.87|0.29|0.674
72595473|NCT01362244|144722388|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.94||||0.942|TWO_SIDED|95.0|0.2|4.49|||Regression, Logistic||Week 5|||4.49|0.20|0.942
72595474|NCT01362244|144722388|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|3.9||||0.091|TWO_SIDED|95.0|0.8|18.96|||Regression, Logistic||Week 9|||18.96|0.80|0.091
72595475|NCT01362244|144722388|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|11.66||||0.004|TWO_SIDED|95.0|2.18|62.33|||Regression, Logistic||Week 13|||62.33|2.18|0.004
72595476|NCT01362244|144722388|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.74||||0.224|TWO_SIDED|95.0|0.54|13.9|||Regression, Logistic||Week 17|||13.90|0.54|0.224
72595477|NCT01362244|144722388|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|5.85||||0.037|TWO_SIDED|95.0|1.11|30.69|||Regression, Logistic||Week 21|||30.69|1.11|0.037
72595478|NCT01362244|144722388|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|5.22||||0.051|TWO_SIDED|95.0|0.99|27.44|||Regression, Logistic||Week 25|||27.44|0.99|0.051
72595479|NCT01362244|144722405|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.04||||0.567|TWO_SIDED|95.0|-0.1|0.19|||repeated measures model||Week 2|||0.19|-0.10|0.567
72595480|NCT01362244|144722405|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.05||||0.495|TWO_SIDED|95.0|-0.1|0.21|||repeated measures model||Week 5|||0.21|-0.10|0.495
72595481|NCT01362244|144722405|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.09||||0.365|TWO_SIDED|95.0|-0.1|0.28|||repeated measures model||Week 9|||0.28|-0.10|0.365
72595482|NCT01362244|144722405|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.17||||0.058|TWO_SIDED|95.0|-0.01|0.34|||repeated measures model||Week 13|||0.34|-0.01|0.058
72595483|NCT01362244|144722405|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.21||||0.056|TWO_SIDED|95.0|-0.01|0.43|||repeated measures model||Week 17|||0.43|-0.01|0.056
72595484|NCT01362244|144722405|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.23||||0.028|TWO_SIDED|95.0|0.03|0.42|||repeated measures model||Week 21|||0.42|0.03|0.028
72595485|NCT01362244|144722405|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.16||||0.077|TWO_SIDED|95.0|-0.02|0.34|||repeated measures model||Week 25|||0.34|-0.02|0.077
72595486|NCT01362244|144722406|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.06||||0.486|TWO_SIDED|95.0|-0.1|0.22|||repeated measures model||Week 2|||0.22|-0.10|0.486
72595487|NCT01362244|144722406|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.07||||0.384|TWO_SIDED|95.0|-0.08|0.22|||repeated measures model||Week 5|||0.22|-0.08|0.384
72595488|NCT01362244|144722406|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.06||||0.546|TWO_SIDED|95.0|-0.14|0.26|||repeated measures model||Week 9|||0.26|-0.14|0.546
72595489|NCT01362244|144722406|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.2||||0.05|TWO_SIDED|95.0|0.0|0.39|||repeated measures model||Week 13|||0.39|0.00|0.050
72595490|NCT01362244|144722406|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.22||||0.061|TWO_SIDED|95.0|-0.01|0.45|||repeated measures model||Week 17|||0.45|-0.01|0.061
72595491|NCT01362244|144722406|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.28||||0.016|TWO_SIDED|95.0|0.05|0.51|||repeated measures model||Week 21|||0.51|0.05|0.016
72595492|NCT01362244|144722406|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.18||||0.094|TWO_SIDED|95.0|-0.03|0.4|||repeated measures model||Week 25|||0.40|-0.03|0.094
72595493|NCT01362244|144722407|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.11||||0.686|TWO_SIDED|95.0|-19.91|30.12|||repeated measures model||Week 2|||30.12|-19.91|0.686
72595494|NCT01362244|144722407|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|14.55||||0.321|TWO_SIDED|95.0|-14.4|43.5|||repeated measures model||Week 5|||43.50|-14.40|0.321
72595495|NCT01362244|144722407|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|8.91||||0.622|TWO_SIDED|95.0|-26.79|44.6|||repeated measures model||Week 9|||44.60|-26.79|0.622
72595496|NCT01362244|144722407|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|23.24||||0.178|TWO_SIDED|95.0|-10.75|57.22|||repeated measures model||Week 13|||57.22|-10.75|0.178
72595497|NCT01362244|144722407|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|38.16||||0.052|TWO_SIDED|95.0|-0.33|76.66|||repeated measures model||Week 17|||76.66|-0.33|0.052
72595498|NCT01362244|144722407|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|38.72||||0.042|TWO_SIDED|95.0|1.41|76.02|||repeated measures model||Week 21|||76.02|1.41|0.042
72595499|NCT01362244|144722407|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|14.13||||0.484|TWO_SIDED|95.0|-25.76|54.02|||repeated measures model||Week 25|||54.02|-25.76|0.484
72595500|NCT01362244|144722409|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|21.16||||0.005|TWO_SIDED|95.0|6.49|35.83|||repeated measures model||Week 2|||35.83|6.49|0.005
72595501|NCT01362244|144722409|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|16.89||||0.029|TWO_SIDED|95.0|1.77|32.01|||repeated measures model||Week 5|||32.01|1.77|0.029
72595502|NCT01362244|144722409|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|7.2||||0.472|TWO_SIDED|95.0|-12.64|27.03|||repeated measures model||Week 9|||27.03|-12.64|0.472
72595503|NCT01362244|144722409|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|27.71||||0.009|TWO_SIDED|95.0|7.19|48.23|||repeated measures model||Week 13|||48.23|7.19|0.009
72595504|NCT01362244|144722409|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|15.4||||0.114|TWO_SIDED|95.0|-3.8|34.59|||repeated measures model||Week 17|||34.59|-3.80|0.114
72595505|NCT01362244|144722409|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|29.51||||0.014|TWO_SIDED|95.0|6.06|52.96|||repeated measures model||Week 21|||52.96|6.06|0.014
72595506|NCT01362244|144722409|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|26.65||||0.027|TWO_SIDED|95.0|3.1|50.21|||repeated measures model||Week 25|||50.21|3.10|0.027
72595507|NCT01362244|144722410|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.09||||0.79|TWO_SIDED|95.0|-0.61|0.79|||repeated measures model||MNS, Week 2|||0.79|-0.61|0.790
72595508|NCT01362244|144722410|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.14||||0.008|TWO_SIDED|95.0|0.3|1.97|||repeated measures model||MNS, Week 5|||1.97|0.30|0.008
72595509|NCT01362244|144722410|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.79||||0.066|TWO_SIDED|95.0|-0.05|1.64|||repeated measures model||MNS, Week 9|||1.64|-0.05|0.066
72595510|NCT01362244|144722410|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.73||||0.127|TWO_SIDED|95.0|-0.21|1.67|||repeated measures model||MNS, Week 13|||1.67|-0.21|0.127
72595511|NCT01362244|144722410|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.38||||0.481|TWO_SIDED|95.0|-0.69|1.46|||repeated measures model||MNS, Week 17|||1.46|-0.69|0.481
72595512|NCT01362244|144722410|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.65||||0.308|TWO_SIDED|95.0|-0.61|1.9|||repeated measures model||MNS, Week 21|||1.90|-0.61|0.308
72595513|NCT01362244|144722410|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.71||||0.233|TWO_SIDED|95.0|-0.46|1.88|||repeated measures model||MNS, Week 25|||1.88|-0.46|0.233
72595514|NCT01362244|144722410|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.28||||0.444|TWO_SIDED|95.0|-0.45|1.02|||repeated measures model||WNS, Week 2|||1.02|-0.45|0.444
72595515|NCT01362244|144722410|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.31||||0.002|TWO_SIDED|95.0|0.5|2.12|||repeated measures model||WNS, Week 5|||2.12|0.50|0.002
72595516|NCT01362244|144722410|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.68||||0.143|TWO_SIDED|95.0|-0.24|1.6|||repeated measures model||WNS, Week 9|||1.60|-0.24|0.143
72595517|NCT01362244|144722410|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.62||||0.24|TWO_SIDED|95.0|-0.42|1.65|||repeated measures model||WNS, Week 13|||1.65|-0.42|0.240
72595518|NCT01362244|144722410|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.19||||0.75|TWO_SIDED|95.0|-0.98|1.35|||repeated measures model||WNS, Week 17|||1.35|-0.98|0.750
72595519|NCT01362244|144722410|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.64||||0.324|TWO_SIDED|95.0|-0.64|1.91|||repeated measures model||WNS, Week 21|||1.91|-0.64|0.324
72595520|NCT01362244|144722410|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.44||||0.468|TWO_SIDED|95.0|-0.77|1.66|||repeated measures model||WNS, Week 25|||1.66|-0.77|0.468
72595521|NCT01362244|144722411|SUPERIORITY_OR_OTHER_LEGACY||Mixed effects model|-13.2||||0.005|TWO_SIDED|95.0|-22.2|-4.22|||ANCOVA|||||-4.22|-22.2|0.005
72595522|NCT01362244|144722412|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0|||||TWO_SIDED|95.0|-0.06|0.07||||||||0.07|-0.06|
72595523|NCT01362244|144722413|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.68|||||TWO_SIDED|95.0|-1.33|12.68||||||||12.68|-1.33|
72595524|NCT01172808|144722472|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.236|STANDARD_ERROR_OF_MEAN|0.028|<|0.0001|TWO_SIDED|95.0|0.181|0.291|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R2.5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||0.291|0.181|<0.0001
72415172|NCT02207816|144340656|SUPERIORITY||Vaccine efficacy|19.15|||<|0.0001|TWO_SIDED|95.0|10.81|26.71|||Negative binomial regression|Mixed model with over-dispersion parameter estimated from the random effect \[Lievens, 2011\].||Vaccine efficacy (VE)/incidence comparison against all episodes of clinical malaria were estimated as 1-incidence ratio (IR; total number of events/follow-up time in the GSK257049 Comparator \[5-17M\] Group over the total number of events/follow-up time in the VeroRab Comparator \[5-17M\] Group).||26.71|10.81|<.0001
72595525|NCT01172808|144722472|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.198|STANDARD_ERROR_OF_MEAN|0.028|<|0.0001|TWO_SIDED|95.0|0.142|0.253|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre , week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||0.253|0.142|<0.0001
72595526|NCT01172808|144722473|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.185|STANDARD_ERROR_OF_MEAN|0.03|<|0.0001|TWO_SIDED|95.0|0.126|0.244|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R2.5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||0.244|0.126|<0.0001
72595527|NCT01172808|144722473|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.152|STANDARD_ERROR_OF_MEAN|0.03|<|0.0001|TWO_SIDED|95.0|0.092|0.211|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction.||0.211|0.092|<0.0001
72595528|NCT01172808|144722474|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.174|STANDARD_ERROR_OF_MEAN|0.03|<|0.0001|TWO_SIDED|95.0|0.114|0.233|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R2.5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||0.233|0.114|<0.0001
72415173|NCT02207816|144340656|SUPERIORITY||Vaccine efficacy|15.55||||0.0009|TWO_SIDED|95.0|6.72|23.54|||Negative binomial regression|Mixed model with over-dispersion parameter estimated from the random effect \[Lievens, 2011\].||Vaccine efficacy (VE)/incidence comparison against all episodes of clinical malaria were estimated as 1-incidence ratio (IR; total number of events/follow-up time in the GSK257049 \[6-12W\] Group over the total number of events/follow-up time in the Menjugate Comparator \[6-12W\] Group).||23.54|6.72|0.0009
72595529|NCT01172808|144722474|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.102|STANDARD_ERROR_OF_MEAN|0.031||0.0008|TWO_SIDED|95.0|0.042|0.162|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model. Spatial power used as covariance structure. The Kenward-Roger approximation was used to estimate denominator degrees of freedom.||0.162|0.042|0.0008
72595530|NCT01172808|144722475|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.125|STANDARD_ERROR_OF_MEAN|0.032||0.0001|TWO_SIDED|95.0|0.062|0.189|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R2.5 - Placebo|Analyses included the fixed, categorical effects of treatment, country, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||0.189|0.062|0.0001
72595531|NCT01172808|144722475|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.076|STANDARD_ERROR_OF_MEAN|0.033||0.02|TWO_SIDED|95.0|0.012|0.14|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R5 - Placebo|Analyses included the fixed, categorical effects of treatment, country, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||0.140|0.012|0.0200
72595532|NCT01172808|144722476|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.224|STANDARD_ERROR_OF_MEAN|0.027|<|0.0001|TWO_SIDED|95.0|0.171|0.278|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R2.5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||0.278|0.171|<0.0001
72595533|NCT01172808|144722476|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.195|STANDARD_ERROR_OF_MEAN|0.027|<|0.0001|TWO_SIDED|95.0|0.141|0.249|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||0.249|0.141|<0.0001
72595534|NCT01172808|144722477|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.158|STANDARD_ERROR_OF_MEAN|0.029|<|0.0001|TWO_SIDED|95.0|0.1|0.215|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R2.5 - Placebo|Analyses included the fixed, categorical effects of treatment, country, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||0.215|0.100|<0.0001
72595535|NCT01172808|144722477|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.106|STANDARD_ERROR_OF_MEAN|0.029||0.0003|TWO_SIDED|95.0|0.049|0.164|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R5 - Placebo|Analyses included the fixed, categorical effects of treatment, country, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||0.164|0.049|0.0003
72595536|NCT01172808|144722478|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|37.907|STANDARD_ERROR_OF_MEAN|4.994|<|0.0001|TWO_SIDED|95.0|28.113|47.7|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R2.5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||47.700|28.113|<0.0001
72595537|NCT01172808|144722478|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|33.677|STANDARD_ERROR_OF_MEAN|5.023|<|0.0001|TWO_SIDED|95.0|23.825|43.529|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||43.529|23.825|<0.0001
72595538|NCT01172808|144722479|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.073|STANDARD_ERROR_OF_MEAN|0.066||0.2717|TWO_SIDED|95.0|-0.057|0.203|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R2.5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||0.203|-0.057|0.2717
72595539|NCT01172808|144722479|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.07|STANDARD_ERROR_OF_MEAN|0.067||0.2956|TWO_SIDED|95.0|-0.061|0.201|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||0.201|-0.061|0.2956
72595540|NCT01172808|144722480|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.202|STANDARD_ERROR_OF_MEAN|0.059||0.0007|TWO_SIDED|95.0|-0.318|-0.085|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R2.5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||-0.085|-0.318|0.0007
72595541|NCT01172808|144722480|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.133|STANDARD_ERROR_OF_MEAN|0.06||0.0262|TWO_SIDED|95.0|-0.25|-0.016|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||-0.016|-0.250|0.0262
72595542|NCT01172808|144722481|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.47||||0.0377|TWO_SIDED|95.0|1.02|2.11||Calculated as 2\*one-sided-p-value in the direction corresponding to testing the null hypothesis|Fisher Exact||Tio R2.5 / Placebo|||2.11|1.02|0.0377
72595543|NCT01172808|144722481|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.76||||0.0022|TWO_SIDED|95.0|1.22|2.54||Calculated as 2\*one-sided-p-value in the direction corresponding to testing the null hypothesis|Fisher Exact||Tio R5 / Placebo|||2.54|1.22|0.0022
72595544|NCT01172808|144722482|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|30.591|STANDARD_ERROR_OF_MEAN|4.52|<|0.0001|TWO_SIDED|95.0|21.726|39.455|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R2.5 - Placebo|Analyses included the fixed, categorical effects of treatment, country, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||39.455|21.726|<0.0001
72415174|NCT02207816|144340656|SUPERIORITY||Vaccine efficacy|13.15||||0.0056|TWO_SIDED|95.0|4.05|21.39|||Negative binomial regression|Mixed model with over-dispersion parameter estimated from the random effect \[Lievens, 2011\].||Vaccine efficacy (VE)/incidence comparison against all episodes of clinical malaria were estimated as 1-incidence ratio (IR; total number of events/follow-up time in the GSK257049 Comparator \[6-12W\] Group over the total number of events/follow-up time in the Menjugate Comparator \[6-12W\] Group).||21.39|4.05|0.0056
72415175|NCT02207816|144340657|SUPERIORITY||Vaccine efficacy|35.5||||0.0053|TWO_SIDED|95.0|10.0|54.0|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) was estimated as 1-the risk ratio (RR; proportion of subjects reporting events in the GSK257049 \[5-17M\] Group over the proportion in VeroRab Comparator \[5-17M\] Group), from Month 0 (study start of Malaria-055) to Year 3 (study end of Malaria-076).||54.00|10.00|0.0053
72595545|NCT01172808|144722482|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|23.66|STANDARD_ERROR_OF_MEAN|4.533|<|0.0001|TWO_SIDED|95.0|14.772|32.549|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R5 - Placebo|Analyses included the fixed, categorical effects of treatment, country, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||32.549|14.772|<0.0001
72595546|NCT01172808|144722483|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|28.16|STANDARD_ERROR_OF_MEAN|4.447|<|0.0001|TWO_SIDED|95.0|19.44|36.88|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R2.5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||36.880|19.440|<0.0001
72595547|NCT01172808|144722483|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|24.37|STANDARD_ERROR_OF_MEAN|4.462|<|0.0001|TWO_SIDED|95.0|15.619|33.12|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||33.120|15.619|<0.0001
72595548|NCT01172808|144722484|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.558|STANDARD_ERROR_OF_MEAN|0.603||0.355|TWO_SIDED|95.0|-1.74|0.624|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R2.5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||0.624|-1.740|0.3550
72595549|NCT01172808|144722484|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.58|STANDARD_ERROR_OF_MEAN|0.608||0.0094|TWO_SIDED|95.0|0.388|2.771|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||2.771|0.388|0.0094
72595550|NCT01172808|144722485|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.081|STANDARD_ERROR_OF_MEAN|0.03||0.0069|TWO_SIDED|95.0|0.022|0.139|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R2.5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||0.139|0.022|0.0069
72595551|NCT01172808|144722485|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.052|STANDARD_ERROR_OF_MEAN|0.03||0.081|TWO_SIDED|95.0|-0.006|0.111|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||0.111|-0.006|0.0810
72595552|NCT01172808|144722486|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.065|STANDARD_ERROR_OF_MEAN|0.031||0.0363|TWO_SIDED|95.0|0.004|0.126|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R2.5 - Placebo|Analyses included the fixed, categorical effects of treatment, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||0.126|0.004|0.0363
72595553|NCT01172808|144722486|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.039|STANDARD_ERROR_OF_MEAN|0.031||0.2077|TWO_SIDED|95.0|-0.022|0.1|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R5 - Placebo|Analyses included the fixed, categorical effects of treatment, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||0.100|-0.022|0.2077
72595554|NCT01172808|144722487|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.162|STANDARD_ERROR_OF_MEAN|0.14||0.2447|TWO_SIDED|95.0|-0.436|0.111|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R2.5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||0.111|-0.436|0.2447
72595555|NCT01172808|144722487|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.144|STANDARD_ERROR_OF_MEAN|0.14||0.3046|TWO_SIDED|95.0|-0.131|0.419|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||0.419|-0.131|0.3046
72595556|NCT01172808|144722488|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.045|STANDARD_ERROR_OF_MEAN|0.029||0.1178|TWO_SIDED|95.0|-0.011|0.102|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R2.5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||0.102|-0.011|0.1178
72595557|NCT01172808|144722488|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.004|STANDARD_ERROR_OF_MEAN|0.029||0.888|TWO_SIDED|95.0|-0.061|0.053|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||0.053|-0.061|0.8880
72595558|NCT01172808|144722489|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.33||||0.0308|TWO_SIDED|95.0|1.03|1.72||Calculated as 2\*one-sided-p-value in the direction corresponding to testing the null hypothesis|Fisher Exact||Tio R2.5 / Placebo|||1.72|1.03|0.0308
72595559|NCT01172808|144722489|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.32||||0.0348|TWO_SIDED|95.0|1.02|1.71||Calculated as 2\*one-sided-p-value in the direction corresponding to testing the null hypothesis|Fisher Exact||Tio R5 / Placebo|||1.71|1.02|0.0348
72595560|NCT03246061|144722494|SUPERIORITY||||||<|0.001||||||Interim Analysis p-value for significance of \<0.025 for an overall alpha of 0.05|ANCOVA|||Estimates and p-value from an ANCOVA with a factor of treatment group and a covariate of baseline ODI score. Values have been adjusted for multiple imputation. Note: 3 month visit is computed as post-treatment for the RF Ablation Arm, and post-randomization for the Control Arm.||||<0.001
72595561|NCT03246061|144722495|SUPERIORITY||||||<|0.001||||||Estimates and p-value from ANCOVA with a factor of treatment group and a covariate of baseline VAS score.|ANCOVA|||||||<0.001
72595562|NCT01492101|144722526|OTHER|Two-sided log-rank test, stratified by geographic region, prior use of eribulin, and receptor status.|Hazard Ratio, log|0.872|||=|0.0835|TWO_SIDED|95.0|0.747|1.019|||Log Rank|||||1.019|0.747|= 0.0835
72595563|NCT01492101|144722527|SUPERIORITY||Hazard Ratio (HR)|0.926|||=|0.3017|TWO_SIDED|95.0|0.798|1.075|||Log Rank|||||1.075|0.798|= 0.3017
72595564|NCT01492101|144722532|EQUIVALENCE|\[2\] - Analysis of variance with change from baseline in linear transformed score at the last visit as the dependent variable and treatment arm, geographic region, prior use of eribulin, and receptor status as fixed effects.|Mean Difference (Final Values)|0.8||||0.635|TWO_SIDED|95.0|-2.65|4.33|||F-test|||Global health status/QoL: change from baseline to last assessment (Week 56)||4.33|-2.65|0.635
72595565|NCT01492101|144722532|EQUIVALENCE|\[3\] - Analysis of variance with change from baseline in linear transformed score at the last visit as the dependent variable and treatment arm, geographic region, prior use of eribulin, and receptor status as fixed effects.|Mean Difference (Final Values)|2.1||||0.1656|TWO_SIDED|95.0|-0.88|5.14|||F-test|||||5.14|-0.88|0.1656
72595566|NCT01492101|144722532|EQUIVALENCE|\[4\] - Analysis of variance with change from baseline in linear transformed score at the last visit as the dependent variable and treatment arm, geographic region, prior use of eribulin, and receptor status as fixed effects.|Median Difference (Final Values)|0.5||||0.8356|TWO_SIDED|95.0|-3.9|4.82|||F-test|||||4.82|-3.9|0.8356
72595567|NCT01492101|144722532|EQUIVALENCE|\[5\] - Analysis of variance with change from baseline in linear transformed score at the last visit as the dependent variable and treatment arm, geographic region, prior use of eribulin, and receptor status as fixed effects.|Mean Difference (Final Values)|0.5||||0.7727|TWO_SIDED|95.0|-2.88|3.88|||F-test|||||3.88|-2.88|0.7727
72415176|NCT02207816|144340657|SUPERIORITY||Vaccine efficacy|11.7||||0.4255|TWO_SIDED|95.0|-20.0|35.2|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) was estimated as 1-the risk ratio (RR; proportion of subjects reporting events in the GSK257049 Comparator \[5-17M\] Group over the proportion in VeroRab Comparator \[5-17M\] Group), Month 0 (study start of Malaria-055) to Year 3 (study end of Malaria-076).||35.20|-20.0|0.4255
72595568|NCT01492101|144722532|EQUIVALENCE|\[6\] - Analysis of variance with change from baseline in linear transformed score at the last visit as the dependent variable and treatment arm, geographic region, prior use of eribulin, and receptor status as fixed effects.|Mean Difference (Final Values)|0.5||||0.7446|TWO_SIDED|95.0|-2.56|3.59|||F-test|||||3.59|-2.56|0.7446
72595569|NCT01492101|144722532|EQUIVALENCE|\[7\] - Analysis of variance with change from baseline in linear transformed score at the last visit as the dependent variable and treatment arm, geographic region, prior use of eribulin, and receptor status as fixed effects.|Mean Difference (Final Values)|0.2||||0.9169|TWO_SIDED|95.0|-4.0|4.45|||F-test|||||4.45|-4.0|0.9169
72595570|NCT01492101|144722532|EQUIVALENCE|\[8\] - Analysis of variance with change from baseline in linear transformed score at the last visit as the dependent variable and treatment arm, geographic region, prior use of eribulin, and receptor status as fixed effects.|Mean Difference (Final Values)|0.1||||0.9731|TWO_SIDED|95.0|-3.66|3.79|||F-test|||||3.79|-3.66|0.9731
72595571|NCT01492101|144722532|EQUIVALENCE|\[9\] - Analysis of variance with change from baseline in linear transformed score at the last visit as the dependent variable and treatment arm, geographic region, prior use of eribulin, and receptor status as fixed effects.|Mean Difference (Final Values)|7.3|||<|0.0001|TWO_SIDED|95.0|3.88|10.67|||F-test|||||10.67|3.88|<0.0001
72595572|NCT01492101|144722532|EQUIVALENCE|\[10\] - Analysis of variance with change from baseline in linear transformed score at the last visit as the dependent variable and treatment arm, geographic region, prior use of eribulin, and receptor status as fixed effects.|Mean Difference (Final Values)|-2.8||||0.1252|TWO_SIDED|95.0|-7.59|0.93|||F-test|||||0.93|-7.59|0.1252
72595573|NCT01492101|144722532|EQUIVALENCE|\[11\] - Analysis of variance with change from baseline in linear transformed score at the last visit as the dependent variable and treatment arm, geographic region, prior use of eribulin, and receptor status as fixed effects.|Mean Difference (Final Values)|-2.8||||0.1717|TWO_SIDED|95.0|-6.83|1.22|||F-test|||||1.22|-6.83|0.1717
72595574|NCT01492101|144722532|EQUIVALENCE|\[12\] - Analysis of variance with change from baseline in linear transformed score at the last visit as the dependent variable and treatment arm, geographic region, prior use of eribulin, and receptor status as fixed effects.|Mean Difference (Final Values)|-1.4||||0.5513|TWO_SIDED|95.0|-5.95|3.18|||F-test|||||3.18|-5.95|0.5513
72595575|NCT01492101|144722532|EQUIVALENCE|\[13\] - Analysis of variance with change from baseline in linear transformed score at the last visit as the dependent variable and treatment arm, geographic region, prior use of eribulin, and receptor status as fixed effects.|Mean Difference (Final Values)|8.6||||0.0009|TWO_SIDED|95.0|3.57|13.72|||F-test|||||13.72|3.57|0.0009
72595576|NCT01492101|144722532|EQUIVALENCE|\[14\] - Analysis of variance with change from baseline in linear transformed score at the last visit as the dependent variable and treatment arm, geographic region, prior use of eribulin, and receptor status as fixed effects.|Mean Difference (Final Values)|-2.8||||0.2337|TWO_SIDED|95.0|-7.35|1.8|||F-test|||||1.8|-7.35|0.2337
72595577|NCT01492101|144722532|EQUIVALENCE|\[15\] - Analysis of variance with change from baseline in linear transformed score at the last visit as the dependent variable and treatment arm, geographic region, prior use of eribulin, and receptor status as fixed effects.|Mean Difference (Final Values)|10.3|||<|0.0001|TWO_SIDED|95.0|6.6|13.98|||F-test|||||13.98|6.6|<0.0001
72595578|NCT01492101|144722532|EQUIVALENCE|\[16\] - Analysis of variance with change from baseline in linear transformed score at the last visit as the dependent variable and treatment arm, geographic region, prior use of eribulin, and receptor status as fixed effects.|Mean Difference (Final Values)|0.0||||0.99|TWO_SIDED|95.0|-3.74|3.69|||F-test|||||3.69|-3.74|0.99
72595579|NCT01492101|144722534|EQUIVALENCE|\[17\] - Analysis of variance with change from baseline in linear transformed score at the last visit as the dependent variable and treatment arm, geographic region, prior use of eribulin, and receptor status as fixed effects.|Mean Difference (Final Values)|0.9||||0.5833|TWO_SIDED|95.0|-2.42|4.29|||F-test|||||4.29|-2.42|0.5833
72595580|NCT01492101|144722534|EQUIVALENCE|\[18\] - Analysis of variance with change from baseline in linear transformed score at the last visit as the dependent variable and treatment arm, geographic region, prior use of eribulin, and receptor status as fixed effects.|Mean Difference (Final Values)|1.3||||0.3098|TWO_SIDED|95.0|-1.24|3.9|||F-test|||||3.9|-1.24|0.3098
72595581|NCT01492101|144722534|EQUIVALENCE|\[19\] - Analysis of variance with change from baseline in linear transformed score at the last visit as the dependent variable and treatment arm, geographic region, prior use of eribulin, and receptor status as fixed effects.|Mean Difference (Final Values)|1.1||||0.6264|TWO_SIDED|95.0|-3.39|5.63|||F-test|||||5.63|-3.39|0.6264
72595582|NCT01492101|144722534|EQUIVALENCE|\[20\] - Analysis of variance with change from baseline in linear transformed score at the last visit as the dependent variable and treatment arm, geographic region, prior use of eribulin, and receptor status as fixed effects.|Mean Difference (Final Values)|-4.6||||0.0003|TWO_SIDED|95.0|-7.11|-2.1|||F-test|||||-2.1|-7.11|0.0003
72595583|NCT01492101|144722534|EQUIVALENCE|\[21\] - Analysis of variance with change from baseline in linear transformed score at the last visit as the dependent variable and treatment arm, geographic region, prior use of eribulin, and receptor status as fixed effects.|Mean Difference (Final Values)|-1.4||||0.2473|TWO_SIDED|95.0|-3.84|0.99|||F-test|||||0.99|-3.84|0.2473
72595584|NCT01492101|144722534|EQUIVALENCE|\[22\] - Analysis of variance with change from baseline in linear transformed score at the last visit as the dependent variable and treatment arm, geographic region, prior use of eribulin, and receptor status as fixed effects.|Mean Difference (Final Values)|-2.9||||0.0333|TWO_SIDED|95.0|-5.54|-0.23|||F-test|||||-0.23|-5.54|0.0333
72595585|NCT01492101|144722534|EQUIVALENCE|\[23\] - Analysis of variance with change from baseline in linear transformed score at the last visit as the dependent variable and treatment arm, geographic region, prior use of eribulin, and receptor status as fixed effects.|Mean Difference (Final Values)|-4.5||||0.2575|TWO_SIDED|95.0|-12.2|3.28|||F-test|||||3.28|-12.2|0.2575
72595586|NCT01492101|144722534|EQUIVALENCE|\[24\] - Analysis of variance with change from baseline in linear transformed score at the last visit as the dependent variable and treatment arm, geographic region, prior use of eribulin, and receptor status as fixed effects.|Mean Difference (Final Values)|5.6||||0.1072|TWO_SIDED|95.0|-1.22|12.34|||F-test|||||12.34|-1.22|0.1072
72595587|NCT00316914|144722543|SUPERIORITY_OR_OTHER|||||||0.038||95.0||||A priori threshold for the p-value is 0.05 and there was no adjustment for multiple comparisons.|Chi-squared|||Comparison in Percentage of Patients With Oxaliplatin-induced Grade 2+ Chronic Neuropathic Adverse Event between Arms||||0.038
72595588|NCT00316914|144722544|SUPERIORITY_OR_OTHER|||||||0.0503||95.0|||||Log Rank|||Comparison of time to Onset of Grade 2+ Chronic Neurotoxicity between Arms||||0.0503
72595589|NCT00316914|144722545|SUPERIORITY_OR_OTHER|||||||0.4048||95.0|||||Log Rank|||Comparison of Time to Onset of Grade 3+ Chronic Neurotoxicity between Arms||||0.4048
72595590|NCT00316914|144722546|SUPERIORITY_OR_OTHER|||||||0.6556||95.0|||||Log Rank|||Comparison of Average Duration of Chronic Neuropathic Toxicity between Arms||||0.6556
72595591|NCT00316914|144722547|SUPERIORITY_OR_OTHER|||||||0.3238||95.0|||||Chi-squared|||Comparison of Percentage of patients discontinuing therapy for chronic neurotoxicity between Arms||||0.3238
72595592|NCT00316914|144722550|SUPERIORITY_OR_OTHER|||||||0.7498||95.0|||||Chi-squared|||Comparison of Percentage of Patients With Acute Neuropathic Adverse Event between Arms||||0.7498
72595593|NCT00316914|144722553|SUPERIORITY_OR_OTHER|||||||0.234||95.0|||||Kruskal-Wallis|||Comparison of Fatigue NOW between two arms||||0.2340
72595594|NCT00316914|144722553|SUPERIORITY_OR_OTHER|||||||0.201||95.0|||||Kruskal-Wallis|||Comparison of Fatigue USUAL between two arms||||0.2010
72595595|NCT00316914|144722553|SUPERIORITY_OR_OTHER|||||||0.9364||95.0|||||Kruskal-Wallis|||Comparison of Fatigue WORST between two arms||||0.9364
72595596|NCT00316914|144722554|SUPERIORITY_OR_OTHER|||||||0.9364||95.0|||||Kruskal-Wallis|||Fatigue WORST||||0.9364
72595597|NCT00316914|144722554|SUPERIORITY_OR_OTHER|||||||0.6275||95.0|||||Kruskal-Wallis|||Walking||||0.6275
72595598|NCT00316914|144722554|SUPERIORITY_OR_OTHER|||||||0.6988||95.0|||||Kruskal-Wallis|||Buttoning Shirt or Tying Laces||||0.6988
72595599|NCT00316914|144722554|SUPERIORITY_OR_OTHER|||||||0.5124||95.0|||||Kruskal-Wallis|||Diarrhea||||0.5124
72595600|NCT00316914|144722554|SUPERIORITY_OR_OTHER|||||||0.3103||95.0|||||Kruskal-Wallis|||Constipation||||0.3103
72595601|NCT00316914|144722554|SUPERIORITY_OR_OTHER|||||||0.8601||95.0|||||Kruskal-Wallis|||Abdominal Cramping||||0.8601
72595602|NCT00316914|144722554|SUPERIORITY_OR_OTHER|||||||0.2439||95.0|||||Kruskal-Wallis|||Bowel Problems with Normal Activity||||0.2439
72595603|NCT00316914|144722554|SUPERIORITY_OR_OTHER|||||||0.9283||95.0|||||Kruskal-Wallis|||Shortness of Breath (Week 2 - Baseline)||||0.9283
72595604|NCT00316914|144722554|SUPERIORITY_OR_OTHER|||||||0.4715||95.0|||||Kruskal-Wallis|||Swallowing (Week 2 - Baseline)||||0.4715
72595605|NCT00316914|144722554|SUPERIORITY_OR_OTHER|||||||0.5105||95.0|||||Kruskal-Wallis|||Numbness in Fingers, Toes (Week 2 - Baseline)||||0.5105
72595606|NCT00316914|144722554|SUPERIORITY_OR_OTHER|||||||0.2181||95.0|||||Kruskal-Wallis|||Tingling in Fingers, Toes (Week 2 - Baseline)||||0.2181
72595607|NCT04105010|144722555|SUPERIORITY||||||<|0.0001|||||||Binomial test against a null|||||||<0.0001
72595608|NCT02380859|144722580|SUPERIORITY|||||||0.005|||||||ANOVA|||Group (real, sham) x Time (pre, 1d post) x Stepping Direction (forward, backward) ANOVA||||0.005
72595609|NCT02284568|144722594|SUPERIORITY||Mean Difference (Final Values)|0.016|STANDARD_ERROR_OF_MEAN|0.1293||0.903|TWO_SIDED|95.0|-0.239|0.2705||significance at 0.05.|Repeated Measures ANCOVA|||The statistical model was a repeated measures analysis of covariance with treatment group, week, treatment group by week interaction, normalized brain volume at baseline, natural logarithm of T2 lesion volume at baseline, and country as fixed effects.||0.2705|-0.2390|0.903
72595610|NCT02284568|144722596|SUPERIORITY||Hazard Ratio (HR)|0.8||||0.426|TWO_SIDED|95.0|0.48|1.37||significance at 0.05. p-value was from a log-rank test, and estimate and confidence limits were from a Cox model with treatment group as fixed effect, due to the violation of the proportionality assumption.|Log Rank||Laquinimod 0.6 mg vs placebo|The statistical model was a Cox proportional hazards regression model with treatment group, categorical EDSS at baseline (≤4.5 or \>4.5), age at baseline, natural logarithm of T2 lesion volume at baseline, and country as fixed effects.||1.37|0.48|0.426
72595611|NCT02284568|144722597|SUPERIORITY||Hazard Ratio (HR)|1.0||||0.867|TWO_SIDED|95.0|0.68|1.59||significance at 0.05.|Regression, Cox||Laquinimod 0.6 mg vs placebo|The statistical model was a Cox proportional hazards regression model with treatment group, categorical EDSS at baseline (≤4.5 or \>4.5), age at baseline, natural logarithm of T2 lesion volume at baseline, and country as fixed effects.||1.59|0.68|0.867
72595612|NCT02284568|144722598|SUPERIORITY||Mean Difference (Final Values)|-0.325|STANDARD_ERROR_OF_MEAN|0.2679||0.248|TWO_SIDED|95.0|-0.85|0.2||significance at 0.05. The p-value for ranked change from baseline values was from a repeated measures analysis of covariance with trt group, week, treatment group by week interaction, rank of T25FW score at baseline, and country as fixed effects.|Repeated Measures ANCOVA||Laquinimod 0.6 mg vs. placebo treatment effect|placebo n=121 Laquinimod 0.6 mg n=108 The estimate of parameter, standard error, and 95% confidence intervals for change from baseline was from a Mann-Whitney-Wilcoxon Test using Hodges-Lehmann estimates.||0.2000|-0.8500|0.248
72595613|NCT02284568|144722599|SUPERIORITY||Risk Ratio (RR)|0.4|STANDARD_ERROR_OF_MEAN|0.11||0.001|TWO_SIDED|95.0|0.26|0.69||significance at 0.05|negative binomial regression model||Laquinimod 0.6 mg vs. placebo risk ratio|This analysis was performed using baseline adjusted negative binomial regression model (SAS® PROC GENMOD) in which 1 contrast for comparing laquinimod 0.6 mg to placebo was constructed. In addition to the treatment group, the natural logarithm of T2 lesion volume at baseline, age at baseline and country/geographical region (CGR) were used as covariates.||0.69|0.26|0.001
72595614|NCT03000530|144722658|SUPERIORITY||Least Squares Mean Difference|-7.0|STANDARD_ERROR_OF_MEAN|1.6|<|0.0001|TWO_SIDED|95.0|-10.2|-3.9|||Mixed Effect Model for Repeated Measures|The Mixed Effect Model for Repeated Measures (MMRM) included the change from baseline in HAM-D total score at each visit as the dependent variables.||||-3.9|-10.2|< 0.0001
72595615|NCT03000530|144722725|SUPERIORITY||Least Squares Mean Difference|-2.3|STANDARD_ERROR_OF_MEAN|0.99||0.0223|TWO_SIDED|95.0|-4.3|-0.3|||Mixed Effect Model for Repeated Measures|The MMRM included the change from baseline in HAM-D total score at each visit as the dependent variables.||Day 2||-0.3|-4.3|0.0223
72595616|NCT03000530|144722725|SUPERIORITY||Least Squares Mean Difference|-4.1|STANDARD_ERROR_OF_MEAN|1.18||0.001|TWO_SIDED|95.0|-6.4|-1.7|||Mixed Effect Model for Repeated Measures|The MMRM included the change from baseline in HAM-D total score at each visit as the dependent variables.||Day 3||-1.7|-6.4|0.0010
72595617|NCT03000530|144722725|SUPERIORITY||Least Squares Mean Difference|-2.9|STANDARD_ERROR_OF_MEAN|1.27||0.0233|TWO_SIDED|95.0|-5.5|-0.4|||Mixed Effect Model for Repeated Measures|The MMRM included the change from baseline in HAM-D total score at each visit as the dependent variables.||Day 4||-0.4|-5.5|0.0233
72595618|NCT03000530|144722725|SUPERIORITY||Least Squares Mean Difference|-3.8|STANDARD_ERROR_OF_MEAN|1.37||0.0066|TWO_SIDED|95.0|-6.6|-1.1|||Mixed Effect Model for Repeated Measures|The MMRM included the change from baseline in HAM-D total score at each visit as the dependent variables.||Day 5||-1.1|-6.6|0.0066
72595619|NCT03000530|144722725|SUPERIORITY||Least Squares Mean Difference|-4.5|STANDARD_ERROR_OF_MEAN|1.4||0.0019|TWO_SIDED|95.0|-7.3|-1.7|||Mixed Effect Model for Repeated Measures|The MMRM included the change from baseline in HAM-D total score at each visit as the dependent variables.||Day 6||-1.7|-7.3|0.0019
72595620|NCT03000530|144722725|SUPERIORITY||Least Squares Mean Difference|-4.5|STANDARD_ERROR_OF_MEAN|1.53||0.0043|TWO_SIDED|95.0|-7.6|-1.5|||Mixed Effect Model for Repeated Measures|The MMRM included the change from baseline in HAM-D total score at each visit as the dependent variables.||Day 7||-1.5|-7.6|0.0043
72595621|NCT03000530|144722725|SUPERIORITY||Least Squares Mean Difference|-3.4|STANDARD_ERROR_OF_MEAN|1.54||0.0318|TWO_SIDED|95.0|-6.4|-0.3|||Mixed Effect Model for Repeated Measures|The MMRM included the change from baseline in HAM-D total score at each visit as the dependent variables.||Day 8||-0.3|-6.4|0.0318
72595622|NCT03000530|144722725|SUPERIORITY||Least Squares Mean Difference|-7.0|STANDARD_ERROR_OF_MEAN|1.6|<|0.0001|TWO_SIDED|95.0|-10.2|-3.9|||Mixed Effect Model for Repeated Measures|The MMRM included the change from baseline in HAM-D total score at each visit as the dependent variables.||Day 15||-3.9|-10.2|< 0.0001
72595623|NCT03000530|144722725|SUPERIORITY||Least Squares Mean Difference|-4.9|STANDARD_ERROR_OF_MEAN|1.76||0.0064|TWO_SIDED|95.0|-8.4|-1.4|||Mixed Effect Model for Repeated Measures|The MMRM included the change from baseline in HAM-D total score at each visit as the dependent variables.||Day 21||-1.4|-8.4|0.0064
72595624|NCT03000530|144722725|SUPERIORITY||Least Squares Mean Difference|-4.1|STANDARD_ERROR_OF_MEAN|1.77||0.0243|TWO_SIDED|95.0|-7.6|-0.5|||Mixed Effect Model for Repeated Measures|The MMRM included the change from baseline in HAM-D total score at each visit as the dependent variables.||Day 28||-0.5|-7.6|0.0243
72595625|NCT03000530|144722725|SUPERIORITY||Least Squares Mean Difference|-2.3|STANDARD_ERROR_OF_MEAN|1.86||0.2285|TWO_SIDED|95.0|-6.0|1.4|||Mixed Effect Model for Repeated Measures|The MMRM included the change from baseline in HAM-D total score at each visit as the dependent variables.||Day 35||1.4|-6.0|0.2285
72595626|NCT03000530|144722725|SUPERIORITY||Least Squares Mean Difference|-2.3|STANDARD_ERROR_OF_MEAN|1.86||0.212|TWO_SIDED|95.0|-6.0|1.4|||Mixed Effect Model for Repeated Measures|The MMRM included the change from baseline in HAM-D total score at each visit as the dependent variables.||Day 42||1.4|-6.0|0.2120
72595627|NCT03000530|144722726|SUPERIORITY||Odds Ratio (OR)|4.4||||0.0884|TWO_SIDED|95.0|0.8|24.1|||Generalized Estimating Equation|Statistics are from a generalized estimating equation (GEE) method including the HAM-D response at each visit as the dependent variables.|For the model parameters estimation, the exchangeable working correlation structure was used.|Day 2||24.1|0.8|0.0884
72595628|NCT03000530|144722726|SUPERIORITY||Odds Ratio (OR)|2.4||||0.0732|TWO_SIDED|95.0|0.9|6.4|||Generalized Estimating Equation|Statistics are from a GEE method including the HAM-D response at each visit as the dependent variables.|For the model parameters estimation, the exchangeable working correlation structure was used.|Day 8||6.4|0.9|0.0732
72595629|NCT03000530|144722726|SUPERIORITY||Odds Ratio (OR)|9.6||||0.0002|TWO_SIDED|95.0|2.9|31.6|||Generalized Estimating Equation|Statistics are from a GEE method including the HAM-D response at each visit as the dependent variables.|For the model parameters estimation, the exchangeable working correlation structure was used.|Day 15||31.6|2.9|0.0002
72595630|NCT03000530|144722726|SUPERIORITY||Odds Ratio (OR)|6.7||||0.0006|TWO_SIDED|95.0|2.3|19.7|||Generalized Estimating Equation|Statistics are from a GEE method including the HAM-D response at each visit as the dependent variables.|For the model parameters estimation, the exchangeable working correlation structure was used.|Day 21||19.7|2.3|0.0006
72595631|NCT03000530|144722726|SUPERIORITY||Odds Ratio (OR)|3.1||||0.0379|TWO_SIDED|95.0|1.1|8.9|||Generalized Estimating Equation|Statistics are from a GEE method including the HAM-D response at each visit as the dependent variables.|For the model parameters estimation, the exchangeable working correlation structure was used.|Day 28||8.9|1.1|0.0379
72595632|NCT03000530|144722726|SUPERIORITY||Odds Ratio (OR)|3.0||||0.0468|TWO_SIDED|95.0|1.0|9.0|||Generalized Estimating Equation|Statistics are from a GEE method including the HAM-D response at each visit as the dependent variables.|For the model parameters estimation, the exchangeable working correlation structure was used.|Day 35||9.0|1.0|0.0468
72595633|NCT03000530|144722726|SUPERIORITY||Odds Ratio (OR)|1.9||||0.2208|TWO_SIDED|95.0|0.7|5.6|||Generalized Estimating Equation|Statistics are from a GEE method including the HAM-D response at each visit as the dependent variables.|For the model parameters estimation, the exchangeable working correlation structure was used.|Day 42||5.6|0.7|0.2208
72595634|NCT03000530|144722727|SUPERIORITY||Odds Ratio (OR)|1.5||||0.43|TWO_SIDED|95.0|0.6|3.7|||Generalized Estimating Equation|Statistics are from a GEE method including the HAM-D remission at each visit as the dependent variables.|For the model parameters estimation, the exchangeable working correlation structure was used.|Day 8||3.7|0.6|0.4300
72595635|NCT03000530|144722727|SUPERIORITY||Odds Ratio (OR)|5.3||||0.0005|TWO_SIDED|95.0|2.1|13.3|||Generalized Estimating Equation|Statistics are from a GEE method including the HAM-D remission at each visit as the dependent variables.|For the model parameters estimation, the exchangeable working correlation structure was used.|Day 15||13.3|2.1|0.0005
72595636|NCT03000530|144722727|SUPERIORITY||Odds Ratio (OR)|3.1||||0.0172|TWO_SIDED|95.0|1.2|8.0|||Generalized Estimating Equation|Statistics are from a GEE method including the HAM-D remission at each visit as the dependent variables.|For the model parameters estimation, the exchangeable working correlation structure was used.|Day 21||8.0|1.2|0.0172
72595637|NCT03000530|144722727|SUPERIORITY||Odds Ratio (OR)|2.9||||0.0221|TWO_SIDED|95.0|1.2|7.3|||Generalized Estimating Equation|Statistics are from a GEE method including the HAM-D remission at each visit as the dependent variables.|For the model parameters estimation, the exchangeable working correlation structure was used.|Day 28||7.3|1.2|0.0221
72595638|NCT03000530|144722727|SUPERIORITY||Odds Ratio (OR)|1.4||||0.4139|TWO_SIDED|95.0|0.6|3.5|||Generalized Estimating Equation|Statistics are from a GEE method including the HAM-D remission at each visit as the dependent variables.|For the model parameters estimation, the exchangeable working correlation structure was used.|Day 35||3.5|0.6|0.4139
72595639|NCT03000530|144722727|SUPERIORITY||Odds Ratio (OR)|1.7||||0.2332|TWO_SIDED|95.0|0.7|4.3|||Generalized Estimating Equation|Statistics are from a GEE method including the HAM-D remission at each visit as the dependent variables.|For the model parameters estimation, the exchangeable working correlation structure was used.|Day 42||4.3|0.7|0.2332
72595640|NCT03000530|144722728|SUPERIORITY||Least Squares Mean Difference|-2.4|STANDARD_ERROR_OF_MEAN|1.38||0.0836|TWO_SIDED|95.0|-5.1|0.3|||Mixed Effect Model for Repeated Measures|The MMRM included the change from baseline in MADRS total score at each visit as the dependent variable.||Day 2||0.3|-5.1|0.0836
72595641|NCT03000530|144722728|SUPERIORITY||Least Squares Mean Difference|-4.0|STANDARD_ERROR_OF_MEAN|2.32||0.0864|TWO_SIDED|95.0|-8.6|0.6|||Mixed Effect Model for Repeated Measures|The MMRM included the change from baseline in MADRS total score at each visit as the dependent variable.||Day 8||0.6|-8.6|0.0864
72595642|NCT03000530|144722728|SUPERIORITY||Least Squares Mean Difference|-7.6|STANDARD_ERROR_OF_MEAN|2.38||0.0021|TWO_SIDED|95.0|-12.3|-2.8|||Mixed Effect Model for Repeated Measures|The MMRM included the change from baseline in MADRS total score at each visit as the dependent variable.||Day 15||-2.8|-12.3|0.0021
72595643|NCT03000530|144722728|SUPERIORITY||Least Squares Mean Difference|-6.6|STANDARD_ERROR_OF_MEAN|2.69||0.0157|TWO_SIDED|95.0|-12.0|-1.3|||Mixed Effect Model for Repeated Measures|The MMRM included the change from baseline in MADRS total score at each visit as the dependent variable.||Day 21||-1.3|-12.0|0.0157
72595644|NCT03000530|144722728|SUPERIORITY||Least Squares Mean Difference|-5.3|STANDARD_ERROR_OF_MEAN|2.69||0.0533|TWO_SIDED|95.0|-10.6|0.1|||Mixed Effect Model for Repeated Measures|The MMRM included the change from baseline in MADRS total score at each visit as the dependent variable.||Day 28||0.1|-10.6|0.0533
72595645|NCT03000530|144722728|SUPERIORITY||Least Squares Mean Difference|-3.1|STANDARD_ERROR_OF_MEAN|2.87||0.2878|TWO_SIDED|95.0|-8.8|2.6|||Mixed Effect Model for Repeated Measures|The MMRM included the change from baseline in MADRS total score at each visit as the dependent variable.||Day 35||2.6|-8.8|0.2878
72595646|NCT03000530|144722728|SUPERIORITY||Least Squares Mean Difference|-2.0|STANDARD_ERROR_OF_MEAN|2.7||0.4664|TWO_SIDED|95.0|-7.4|3.4|||Mixed Effect Model for Repeated Measures|The MMRM included the change from baseline in MADRS total score at each visit as the dependent variable.||Day 42||3.4|-7.4|0.4664
72595647|NCT03000530|144722731|SUPERIORITY||Least Squares Mean Difference|-1.8|STANDARD_ERROR_OF_MEAN|0.87||0.0391|TWO_SIDED|95.0|-3.6|-0.1|||Mixed Effect Model for Repeated Measures|The MMRM included the change from baseline in HAM-A total score at each visit as the dependent variable.||Day 2||-0.1|-3.6|0.0391
72595648|NCT03000530|144722731|SUPERIORITY||Least Squares Mean Difference|-2.5|STANDARD_ERROR_OF_MEAN|1.29||0.0516|TWO_SIDED|95.0|-5.1|0.0|||Mixed Effect Model for Repeated Measures|The MMRM included the change from baseline in HAM-A total score at each visit as the dependent variable.||Day 8||0.0|-5.1|0.0516
72595649|NCT03000530|144722731|SUPERIORITY||Least Squares Mean Difference|-4.6|STANDARD_ERROR_OF_MEAN|1.32||0.0008|TWO_SIDED|95.0|-7.3|-2.0|||Mixed Effect Model for Repeated Measures|The MMRM included the change from baseline in HAM-A total score at each visit as the dependent variable.||Day 15||-2.0|-7.3|0.0008
72595650|NCT03000530|144722731|SUPERIORITY||Least Squares Mean Difference|-3.4|STANDARD_ERROR_OF_MEAN|1.54||0.0282|TWO_SIDED|95.0|-6.5|-0.4|||Mixed Effect Model for Repeated Measures|The MMRM included the change from baseline in HAM-A total score at each visit as the dependent variable.||Day 21||-0.4|-6.5|0.0282
72595651|NCT03000530|144722731|SUPERIORITY||Least Squares Mean Difference|-2.2|STANDARD_ERROR_OF_MEAN|1.56||0.1686|TWO_SIDED|95.0|-5.3|0.9|||Mixed Effect Model for Repeated Measures|The MMRM included the change from baseline in HAM-A total score at each visit as the dependent variable.||Day 28||0.9|-5.3|0.1686
72595652|NCT03000530|144722731|SUPERIORITY||Least Squares Mean Difference|-2.0|STANDARD_ERROR_OF_MEAN|1.75||0.2488|TWO_SIDED|95.0|-5.5|1.5|||Mixed Effect Model for Repeated Measures|||Day 35||1.5|-5.5|0.2488
72595653|NCT03000530|144722731|SUPERIORITY||Least Squares Mean Difference|-2.3|STANDARD_ERROR_OF_MEAN|1.76||0.2037|TWO_SIDED|95.0|-5.7|1.2|||Mixed Effect Model for Repeated Measures|The MMRM included the change from baseline in HAM-A total score at each visit as the dependent variable.||Day 42||1.2|-5.7|0.2037
72595654|NCT03000530|144722732|SUPERIORITY||Odds Ratio (OR)|5.5||||0.0048|TWO_SIDED|95.0|1.7|17.9|||Generalized Estimating Equation|Statistics are from a GEE method including the CGI-I response at each visit as the dependent variable.|For the model parameters estimation, the exchangeable working correlation structure was used.|Day 8||17.9|1.7|0.0048
72595655|NCT03000530|144722732|SUPERIORITY||Odds Ratio (OR)|8.6||||0.0007|TWO_SIDED|95.0|2.5|29.5|||Generalized Estimating Equation|Statistics are from a GEE method including the CGI-I response at each visit as the dependent variable.|For the model parameters estimation, the exchangeable working correlation structure was used.|Day 15||29.5|2.5|0.0007
72595656|NCT03000530|144722732|SUPERIORITY||Odds Ratio (OR)|4.4||||0.0113|TWO_SIDED|95.0|1.4|13.6|||Generalized Estimating Equation|Statistics are from a GEE method including the CGI-I response at each visit as the dependent variable.|For the model parameters estimation, the exchangeable working correlation structure was used.|Day 21||13.6|1.4|0.0113
72595657|NCT03000530|144722732|SUPERIORITY||Odds Ratio (OR)|3.9||||0.0227|TWO_SIDED|95.0|1.2|12.8|||Generalized Estimating Equation|Statistics are from a GEE method including the CGI-I response at each visit as the dependent variable.|For the model parameters estimation, the exchangeable working correlation structure was used.|Day 28||12.8|1.2|0.0227
72595658|NCT03000530|144722732|SUPERIORITY||Odds Ratio (OR)|2.3||||0.1516|TWO_SIDED|95.0|0.7|7.2|||Generalized Estimating Equation|Statistics are from a GEE method including the CGI-I response at each visit as the dependent variable.|For the model parameters estimation, the exchangeable working correlation structure was used.|Day 35||7.2|0.7|0.1516
72595659|NCT03000530|144722732|SUPERIORITY||Odds Ratio (OR)|2.7||||0.0793|TWO_SIDED|95.0|0.9|8.3|||Generalized Estimating Equation|Statistics are from a GEE method including the CGI-I response at each visit as the dependent variable.|For the model parameters estimation, the exchangeable working correlation structure was used.|Day 42||8.3|0.9|0.0793
72595660|NCT00625404|144722766|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.94|||||TWO_SIDED|95.0|0.59|1.52||||||Hazard ratio (HR) for HIV infection based on proportional hazards model, stratified on site. Study was designed to have 90% power to reject the null hypothesis that the HR for infection is \> 0.3||1.52|0.59|
72595661|NCT00625404|144722767|SUPERIORITY_OR_OTHER|||||||0.45|||||||Log Rank|||Log-rank test for difference in rate of grade 2 or higher creatinine, based on time to first event.||||0.45
72595662|NCT00625404|144722769|SUPERIORITY_OR_OTHER|||||||0.59|||||||Log Rank|||Log-rank test for difference in rates between groups||||0.59
72595663|NCT00625404|144722770|SUPERIORITY_OR_OTHER|||||||0.79|||||||Log Rank|||Log-rank test for difference in rates between groups||||0.79
72595664|NCT00625404|144722771|SUPERIORITY_OR_OTHER|||||||0.62|||||||Log Rank|||Log-rank test for difference in rates between groups||||0.62
72595665|NCT00625404|144722772|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.03||||0.89|||||||t-test, 2 sided|||t-test for difference on viral loads||||0.89
72595666|NCT00625404|144722773|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|22.1||||0.82|||||||t-test, 2 sided|||t-test for difference in mean CD-4 counts||||0.82
72595667|NCT00625404|144722777|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01||||0.73|||||||t-test, 2 sided|||t-test for difference in change in number of sexual partners over time||||0.73
72595668|NCT01887678|144722782|SUPERIORITY_OR_OTHER||Least Square|-6.37|STANDARD_ERROR_OF_MEAN|3.06||0.0383|TWO_SIDED|95.0|-12.4|-0.35|||ANCOVA||A negative value of the Least Square mean difference indicates a result in favor of Traumeel-Zeel.|||-0.35|-12.40|0.0383
72595669|NCT01887678|144722783|SUPERIORITY_OR_OTHER||Least Squares|-2.15||||0.3715|TWO_SIDED|95.0|-6.89|2.58|||ANCOVA|||Day 8±1||2.58|-6.89|0.3715
72595670|NCT01887678|144722783|SUPERIORITY_OR_OTHER||Least Square|-5.87||||0.0293|TWO_SIDED|95.0|-11.15|-0.6|||ANCOVA|||Day 15±1||-0.60|-11.15|0.0293
72595671|NCT01887678|144722783|SUPERIORITY_OR_OTHER||Least Squares|-5.24||||0.0686|TWO_SIDED|95.0|-10.88|0.4|||ANCOVA|||Day 29±3||0.40|-10.88|0.0686
72595672|NCT01887678|144722783|SUPERIORITY_OR_OTHER||Least Squares|-7.25||||0.015|TWO_SIDED|95.0|-13.08|-1.42|||ANCOVA|||Day 43±3||-1.42|-13.08|0.0150
72595673|NCT01887678|144722783|SUPERIORITY_OR_OTHER||Least Squares|-7.56||||0.0134|TWO_SIDED|95.0|-13.54|-1.58|||ANCOVA|||Day 57±3||-1.58|-13.54|0.0134
72595674|NCT01887678|144722783|SUPERIORITY_OR_OTHER||Least Squares|-7.6||||0.0121|TWO_SIDED|95.0|-13.52|-1.68|||Least Squares|||Day 71±3||-1.68|-13.52|0.0121
72595675|NCT01887678|144722783|SUPERIORITY_OR_OTHER||Least Squares|-6.32||||0.0376|TWO_SIDED|95.0|-12.28|-0.37|||ANCOVA|||Day 85±3||-0.37|-12.28|0.0376
72595676|NCT01887678|144722784|SUPERIORITY_OR_OTHER||Least Squares|-4.76||||0.1373|TWO_SIDED|95.0|-11.05|1.53|||ANCOVA|||||1.53|-11.05|0.1373
72595677|NCT01887678|144722785|SUPERIORITY_OR_OTHER||Least Squares|-4.24||||0.1715|TWO_SIDED|95.0|-10.33|1.85|||ANCOVA|||||1.85|-10.33|0.1715
72595678|NCT01887678|144722786|SUPERIORITY_OR_OTHER||Least Squares|-4.77||||0.1211|TWO_SIDED|95.0|-10.82|1.27|||ANCOVA|||||1.27|-10.82|0.1211
72595679|NCT01887678|144722791|SUPERIORITY_OR_OTHER||Least Squares|-4.97||||0.1128|TWO_SIDED|95.0|-11.12|1.18|||ANCOVA|||Day 8±1||1.18|-11.12|0.1128
72595680|NCT01887678|144722791|SUPERIORITY_OR_OTHER||Least Squares|-10.49||||0.0013|TWO_SIDED|95.0|-16.85|-4.13|||ANCOVA|||Day 15±1||-4.13|-16.85|0.0013
72595681|NCT01887678|144722791|SUPERIORITY_OR_OTHER||Least Squares|-6.89||||0.0472|TWO_SIDED|95.0|-13.69|-0.09|||ANCOVA|||Day 29±3||-0.09|-13.69|0.0472
72595682|NCT01887678|144722791|SUPERIORITY_OR_OTHER||Least Squares|-8.82||||0.0109|TWO_SIDED|95.0|-15.6|-2.05|||ANCOVA|||Day 43±3||-2.05|-15.60|0.0109
72595683|NCT01887678|144722791|SUPERIORITY_OR_OTHER||Least Squares|-8.88||||0.0123|TWO_SIDED|95.0|-15.8|-1.95|||ANCOVA|||Day 57±3||-1.95|-15.80|0.0123
72595684|NCT01887678|144722791|SUPERIORITY_OR_OTHER||Least Squares|-6.88||||0.0425|TWO_SIDED|95.0|-13.52|-0.23|||ANCOVA|||Day 71±3||-0.23|-13.52|0.0425
72595685|NCT01887678|144722791|SUPERIORITY_OR_OTHER||Least Squares|-5.51||||0.1199|TWO_SIDED|95.0|-12.47|1.45|||ANCOVA|||Day 85±3||1.45|-12.47|0.1199
72595686|NCT01887678|144722791|SUPERIORITY_OR_OTHER||Least Squares|-4.96||||0.1575|TWO_SIDED|95.0|-11.86|1.93|||ANCOVA|||Day 119±3||1.93|-11.86|0.1575
72595687|NCT01887678|144722792|SUPERIORITY_OR_OTHER||Least Squares|-0.28||||0.6346|TWO_SIDED|95.0|-1.45|0.89|||ANCOVA|||Day 8±1||0.89|-1.45|0.6346
72595688|NCT01887678|144722792|SUPERIORITY_OR_OTHER||Least Squares|-0.28||||0.6458|TWO_SIDED|95.0|-1.49|0.92|||ANCOVA|||Day 15±1||0.92|-1.49|0.6458
72595689|NCT01887678|144722792|SUPERIORITY_OR_OTHER||Least Squares|-0.18||||0.7581|TWO_SIDED|95.0|-1.35|0.99|||ANCOVA|||Day 29±3||0.99|-1.35|0.7581
72595690|NCT01887678|144722792|SUPERIORITY_OR_OTHER||Least Squares|-0.49||||0.335|TWO_SIDED|95.0|-1.48|0.51|||ANCOVA|||Day 43±3||0.51|-1.48|0.3350
72595691|NCT01887678|144722792|SUPERIORITY_OR_OTHER||Least Squares|-0.4||||0.4419|TWO_SIDED|95.0|-1.44|0.63|||ANCOVA|||Day 57±3||0.63|-1.44|0.4419
72595692|NCT01887678|144722792|SUPERIORITY_OR_OTHER||Least Squares|-0.37||||0.446|TWO_SIDED|95.0|-1.32|0.58|||ANCOVA|||Day 71±3||0.58|-1.32|0.4460
72595693|NCT01887678|144722792|SUPERIORITY_OR_OTHER||Least Squares|0.25||||0.6552|TWO_SIDED|95.0|-0.84|1.33|||ANCOVA|||Day 85±3||1.33|-0.84|0.6552
72595694|NCT01887678|144722792|SUPERIORITY_OR_OTHER||Least Squares|-0.19||||0.7443|TWO_SIDED|95.0|-1.33|0.95|||ANCOVA|||Day 119±3||0.95|-1.33|0.7443
72595695|NCT01887678|144722797|SUPERIORITY_OR_OTHER|||||||0.2164|TWO_SIDED||||||Log Rank|Results of Kaplan-Meier Analysis with p-value from 2-sided log-rank test for equality of survival functions||After first injection of study drug||||0.2164
72595696|NCT01887678|144722797|SUPERIORITY_OR_OTHER|||||||0.1651|TWO_SIDED|||||Results of Kaplan-Meier Analysis with p-value from 2-sided log-rank test for equality of survival functions|Log Rank|||After second injection of study drug||||0.1651
72595697|NCT01887678|144722797|SUPERIORITY_OR_OTHER|||||||0.222|TWO_SIDED||||||Log Rank|Results of Kaplan-Meier Analysis with p-value from 2-sided log-rank test for equality of survival functions||After third injection of study drug||||0.2220
72595698|NCT01887678|144722798|SUPERIORITY_OR_OTHER|||||||0.0264|TWO_SIDED||||||Log Rank|For equality of survival functions||After first injection of study drug||||0.0264
72595699|NCT01887678|144722798|SUPERIORITY_OR_OTHER|||||||0.0346|TWO_SIDED||||||Log Rank|For equality of survival functions||After second injection of study drug||||0.0346
72595700|NCT01887678|144722798|SUPERIORITY_OR_OTHER|||||||0.0172|TWO_SIDED||||||Log Rank|For equality of survival functions||After third injection of study drug||||0.0172
72595701|NCT00678470|144722867|OTHER||Correlation|1.0||||0.0003|TWO_SIDED||||||Fisher Exact||||Using Fisher's non-parametric test of associations, correlations were determined between the patients who were intralesional responders with their response at ‡70% change in PASI score.|||0.0003
72595702|NCT00586508|144722914|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3375||||||P-value is for Physical Well-Being Cycle 1.|ANCOVA|P-value of treatment effect from an Analysis of Covariance (ANCOVA) for change from baseline. Covariates include: treatment and baseline value.||||||0.3375
72595703|NCT00586508|144722914|SUPERIORITY_OR_OTHER_LEGACY|||||||0.516||||||P-value is for Physical Well-Being Cycle 2.|ANCOVA|P-value of treatment effect from an ANCOVA for change from baseline. Covariates include: treatment and baseline value.||||||0.516
72595704|NCT00586508|144722914|SUPERIORITY_OR_OTHER_LEGACY|||||||0.786||||||P-value is for Physical Well-Being Cycle 3.|ANCOVA|P-value of treatment effect from an ANCOVA for change from baseline. Covariates include: treatment and baseline value.||||||0.786
72595705|NCT00586508|144722914|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1496||||||P-value is for Physical Well-Being Cycle 4.|ANCOVA|P-value of treatment effect from an ANCOVA for change from baseline. Covariates include: treatment and baseline value.||||||0.1496
72595706|NCT00586508|144722914|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8428||||||P-value is for Physical Well-Being Cycle 5.|ANCOVA|P-value of treatment effect from an ANCOVA for change from baseline. Covariates include: treatment and baseline value.||||||0.8428
72595707|NCT00586508|144722914|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7345||||||P-value is for Physical Well-Being Cycle 6.|ANCOVA|P-value of treatment effect from an ANCOVA for change from baseline. Covariates include: treatment and baseline value.||||||0.7345
72595708|NCT00586508|144722914|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8928||||||P-value is for Physical Well-Being Cycle 7.|ANCOVA|P-value of treatment effect from an ANCOVA for change from baseline. Covariates include: treatment and baseline value.||||||0.8928
72595709|NCT00586508|144722914|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7343||||||P-value is for Physical Well-Being Cycle 8.|ANCOVA|P-value of treatment effect from an ANCOVA for change from baseline. Covariates include: treatment and baseline value.||||||0.7343
72595710|NCT00586508|144722914|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8798||||||P-value is for Social/Family Well-Being Cycle 1.|ANCOVA|P-value of treatment effect from an ANCOVA for change from baseline. Covariates include: treatment and baseline value.||||||0.8798
72595711|NCT00586508|144722914|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6837||||||P-value is for Social/Family Well-Being Cycle 2.|ANCOVA|P-value of treatment effect from an ANCOVA for change from baseline. Covariates include: treatment and baseline value.||||||0.6837
72595712|NCT00586508|144722914|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7226||||||P-value is for Social/Family Well-Being Cycle 3.|ANCOVA|P-value of treatment effect from an ANCOVA for change from baseline. Covariates include: treatment and baseline value.||||||0.7226
72595713|NCT00586508|144722914|SUPERIORITY_OR_OTHER_LEGACY|||||||0.641||||||P-value is for Social/Family Well-Being Cycle 4.|ANCOVA|P-value of treatment effect from an ANCOVA for change from baseline. Covariates include: treatment and baseline value.||||||0.641
72595714|NCT00586508|144722914|SUPERIORITY_OR_OTHER_LEGACY|||||||0.478||||||P-value is for Social/Family Well-Being Cycle 5.|ANCOVA|P-value of treatment effect from an ANCOVA for change from baseline. Covariates include: treatment and baseline value.||||||0.478
72595715|NCT00586508|144722914|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9367||||||P-value is for Social/Family Well-Being Cycle 6.|ANCOVA|P-value of treatment effect from an ANCOVA for change from baseline. Covariates include: treatment and baseline value.||||||0.9367
72415177|NCT02207816|144340657|SUPERIORITY||Vaccine efficacy|29.2||||0.0479|TWO_SIDED|95.0|-2.4|51.4|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) was estimated as 1-the risk ratio (RR; proportion of subjects reporting events in the GSK257049 \[6-12W\] Group over the proportion in Menjugate Comparator \[6-12W\] Group), from Month 0 (study start of Malaria-055) to Year 3 (study end of Malaria-076).||51.40|-2.40|0.0479
72415178|NCT02207816|144340657|SUPERIORITY||Vaccine efficacy|18.1||||0.2346|TWO_SIDED|95.0|-16.9|42.8|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) was estimated as 1-the risk ratio (RR; proportion of subjects reporting events in the GSK257049 Comparator \[6-12W\] Group over the proportion in Menjugate Comparator \[6-12W\] Group), from Month 0 (study start of Malaria-055) to Year 3 (study end of Malaria-076).||42.80|-16.9|0.2346
72595716|NCT00586508|144722914|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5108||||||P-value is for Social/Family Well-Being Cycle 7.|ANCOVA|P-value of treatment effect from an ANCOVA for change from baseline. Covariates include: treatment and baseline value.||||||0.5108
72595717|NCT00586508|144722914|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8976||||||P-value is for Social/Family Well-Being Cycle 8.|ANCOVA|P-value of treatment effect from an ANCOVA for change from baseline. Covariates include: treatment and baseline value.||||||0.8976
72595718|NCT00586508|144722914|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8193||||||P-value is for Emotional Well-Being Cycle 1.|ANCOVA|P-value of treatment effect from an ANCOVA for change from baseline. Covariates include: treatment and baseline value.||||||0.8193
72415179|NCT02207816|144340658|SUPERIORITY||Vaccine efficacy|35.9||||0.0051|TWO_SIDED|95.0|10.3|54.4|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) was estimated as 1-the risk ratio (RR; proportion of subjects reporting events in the GSK257049 \[5-17M\] Group over the proportion in VeroRab Comparator \[5-17M\] Group), from Month 0 (study start of Malaria-055) to Year 3 (study end of Malaria-076).||54.40|10.30|0.0051
72415180|NCT02207816|144340658|SUPERIORITY||Vaccine efficacy|14.0||||0.334|TWO_SIDED|95.0|-17.3|37.1|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) was estimated as 1-the risk ratio (RR; proportion of subjects reporting events in the GSK257049 Comparator \[5-17M\] Group over the proportion in VeroRab Comparator \[5-17M\] Group), from Month 0 (study start of Malaria-055) to Year 3 (study end of Malaria-076).||37.10|-17.3|0.3340
72415181|NCT02207816|144340658|SUPERIORITY||Vaccine efficacy|28.5||||0.0511|TWO_SIDED|95.0|-2.9|50.5|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) was estimated as 1-the risk ratio (RR; proportion of subjects reporting events in the GSK257049 \[6-12W\] Group over the proportion in Meenjugate Comparator \[6-12W\] Group), from Month 0 (study start of Malaria-055) to Year 3 (study end of Malaria-076).||50.50|-2.90|0.0511
72415182|NCT02207816|144340658|SUPERIORITY||Vaccine efficacy|20.3||||0.1729|TWO_SIDED|95.0|-13.5|44.2|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) was estimated as 1-the risk ratio (RR; proportion of subjects reporting events in the GSK257049 Comparator \[6-12W\] Group over the proportion in Meenjugate Comparator \[6-12W\] Group), from Month 0 (study start of Malaria-055) to Year 3 (study end of Malaria-076).||44.20|-13.5|0.1729
72415183|NCT02207816|144340661|SUPERIORITY||Vaccine efficacy|50.1||||0.6244|TWO_SIDED|95.0|-859.0|99.2|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) was estimated as 1-the risk ratio (RR; proportion of subjects reporting events in the GSK257049 \[5-17M\] Group over the proportion in VeroRab Comparator \[5-17M\] Group) over the entire follow-up period (from Year 0 to Year 3).||99.20|-859|0.6244
72415184|NCT02207816|144340661|SUPERIORITY||Vaccine efficacy|-5.7||||1|TWO_SIDED|95.0|-1358.0|92.3|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) was estimated as 1-the risk ratio (RR; proportion of subjects reporting events in the GSK257049 Comparator \[5-17M\] Group over the proportion in VeroRab Comparator \[5-17M\] Group) over the entire follow-up period (from Year 0 to Year 3).||92.30|-1358|1.0000
72415185|NCT02207816|144340661|SUPERIORITY||Vaccine efficacy|-188.9||||0.6244|TWO_SIDED|95.0|-15000.0|76.8|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) was estimated as 1-the risk ratio (RR; proportion of subjects reporting events in the GSK257049 \[6-12W\] Group over the proportion in Menjugate Comparator \[6-12W\] Group) over the entire follow-up period (from Year 0 to Year 3).||76.80|-15000|0.6244
72415186|NCT02207816|144340661|SUPERIORITY||Vaccine efficacy|3.1||||1|TWO_SIDED|95.0|-7509.0|98.8|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) was estimated as 1-the risk ratio (RR; proportion of subjects reporting events in the GSK257049 Comparator \[6-12W\] Group over the proportion in Menjugate Comparator \[6-12W\] Group) over the entire follow-up period (from Year 0 to Year 3).||98.80|-7509|1.0000
72595719|NCT00586508|144722914|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1695||||||P-value is for Emotional Well-Being Cycle 2.|ANCOVA|P-value of treatment effect from an ANCOVA for change from baseline. Covariates include: treatment and baseline value.||||||0.1695
72415187|NCT02207816|144340662|SUPERIORITY||Vaccine efficacy|-98.8||||0.6869|TWO_SIDED|95.0|-2098.0|71.5|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) was estimated as 1-the risk ratio (RR; proportion of subjects reporting events in the GSK257049 \[5-17M\] Group over the proportion in VeroRab Comparator \[5-17M\] Group), from Month 0 (study start of Malaria-055) to Year 3 (study end of Malaria-076).||71.50|-2098|0.6869
72415188|NCT02207816|144340662|SUPERIORITY||Vaccine efficacy|-406.0||||0.0213|TWO_SIDED|95.0|-4650.0|-7.8|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) was estimated as 1-the risk ratio (RR; proportion of subjects reporting events in the GSK257049 Comparator \[5-17M\] Group over the proportion in VeroRab Comparator \[5-17M\] Group), from Month 0 (study start of Malaria-055) to Year 3 (study end of Malaria-076).||-7.80|-4650|0.0213
72415189|NCT02207816|144340663|SUPERIORITY||Vaccine efficacy|-98.8||||1|TWO_SIDED|95.0|-12000.0|89.6|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) was estimated as 1-the risk ratio (RR; proportion of subjects reporting events in the GSK257049 \[5-17M\] Group over the proportion in VeroRab Comparator \[5-17M\] Group), from Month 0 (study start of Malaria-055) to Year 3 (study end of Malaria-076).||89.60|-12000|1.0000
72415190|NCT02207816|144340663|SUPERIORITY||Vaccine efficacy|-304.8||||0.2154|TWO_SIDED|95.0|-20000.0|59.9|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) was estimated as 1-the risk ratio (RR; proportion of subjects reporting events in the GSK257049 Comparator \[5-17M\] Group over the proportion in VeroRab Comparator \[5-17M\] Group), from Month 0 (study start of Malaria-055) to Year 3 (study end of Malaria-076).||59.90|-20000|0.2154
72595720|NCT00586508|144722914|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4021||||||P-value is for Emotional Well-Being Cycle 3.|ANCOVA|P-value of treatment effect from an ANCOVA for change from baseline. Covariates include: treatment and baseline value.||||||0.4021
72595721|NCT00586508|144722914|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3603||||||P-value is for Emotional Well-Being Cycle 4.|ANCOVA|P-value of treatment effect from an ANCOVA for change from baseline. Covariates include: treatment and baseline value.||||||0.3603
72595722|NCT00586508|144722914|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5169||||||P-value is for Emotional Well-Being Cycle 5.|ANCOVA|P-value of treatment effect from an ANCOVA for change from baseline. Covariates include: treatment and baseline value.||||||0.5169
72595723|NCT00586508|144722914|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1642||||||P-value is for Emotional Well-Being Cycle 6.|ANCOVA|P-value of treatment effect from an ANCOVA for change from baseline. Covariates include: treatment and baseline value.||||||0.1642
72595724|NCT00586508|144722914|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6354||||||P-value is for Emotional Well-Being Cycle 7.|ANCOVA|P-value of treatment effect from an ANCOVA for change from baseline. Covariates include: treatment and baseline value.||||||0.6354
72595725|NCT00586508|144722914|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3517||||||P-value is for Emotional Well-Being Cycle 8.|ANCOVA|P-value of treatment effect from an ANCOVA for change from baseline. Covariates include: treatment and baseline value.||||||0.3517
72595726|NCT00586508|144722914|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7605||||||P-value is for Functional Well-Being Cycle 1.|ANCOVA|P-value of treatment effect from an ANCOVA for change from baseline. Covariates include: treatment and baseline value.||||||0.7605
72595727|NCT00586508|144722914|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3747||||||P-value is for Functional Well-Being Cycle 2.|ANCOVA|P-value of treatment effect from an ANCOVA for change from baseline. Covariates include: treatment and baseline value.||||||0.3747
72595728|NCT00586508|144722914|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8379||||||P-value is for Functional Well-Being Cycle 3.|ANCOVA|P-value of treatment effect from an ANCOVA for change from baseline. Covariates include: treatment and baseline value.||||||0.8379
72595729|NCT00586508|144722914|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1179||||||P-value is for Functional Well-Being Cycle 4.|ANCOVA|P-value of treatment effect from an ANCOVA for change from baseline. Covariates include: treatment and baseline value.||||||0.1179
72595730|NCT00586508|144722914|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7412||||||P-value is for Functional Well-Being Cycle 5.|ANCOVA|P-value of treatment effect from an ANCOVA for change from baseline. Covariates include: treatment and baseline value.||||||0.7412
72595731|NCT00586508|144722914|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3773||||||P-value is for Functional Well-Being Cycle 6.|ANCOVA|P-value of treatment effect from an ANCOVA for change from baseline. Covariates include: treatment and baseline value.||||||0.3773
72595732|NCT00586508|144722914|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7402||||||P-value is for Functional Well-Being Cycle 7.|ANCOVA|P-value of treatment effect from an ANCOVA for change from baseline. Covariates include: treatment and baseline value.||||||0.7402
72595733|NCT00586508|144722914|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2671||||||P-value is for Functional Well-Being Cycle 8.|ANCOVA|P-value of treatment effect from an ANCOVA for change from baseline. Covariates include: treatment and baseline value.||||||0.2671
72595734|NCT05727306|144722916|SUPERIORITY||Odds Ratio (OR)|1.35|||||TWO_SIDED|95.0|1.25|1.46|||||Calculated as the odds of having a depressive episode in participants diagnosed of Alopecia Areata vs. participants without Alopecia Areata. Odds Ratio adjusted for sociodemographic, clinical characteristics and major comorbidities.|||1.46|1.25|
72595735|NCT05727306|144722917|SUPERIORITY||Odds Ratio (OR)|1.45|||||TWO_SIDED|95.0|1.32|1.58|||||Calculated as the odds of having recurrent depressive disorder in participants diagnosed of Alopecia Areata vs. participants without Alopecia Areata. Odds Ratio adjusted for sociodemographic, clinical characteristics and major comorbidities.|||1.58|1.32|
72595736|NCT05727306|144722918|SUPERIORITY||Odds Ratio (OR)|1.4|||||TWO_SIDED|95.0|1.3|1.51|||||Calculated as the odds of having anxiety in participants diagnosed of Alopecia Areata vs. participants without Alopecia Areata. Odds Ratio adjusted for sociodemographic, clinical characteristics and major comorbidities.|||1.51|1.30|
72595737|NCT05727306|144722919|OTHER||Incidence rate ratio (IRR)|1.42|||||TWO_SIDED|95.0|1.37|1.46|||||Calculated as the incidence rate of attending primary care in participants diagnosed of Alopecia Areata vs. participants without Alopecia Areata. Incidence rate ratio adjusted for sociodemographic, clinical characteristics and major comorbidities.|||1.46|1.37|
72595738|NCT05727306|144722920|OTHER||Hazard Ratio (HR)|8.26|||||TWO_SIDED|95.0|7.55|9.04|||||Calculated using Cox Proportional Hazard model.Reflects a comparison of incidence rates between participants diagnosed with Alopecia Areata (AA) and those without AA. Adjusted for sociodemographic,clinical characteristics and major comorbidities.|||9.04|7.55|
72595739|NCT05727306|144722921|OTHER||Hazard Ratio (HR)|1.36|||||TWO_SIDED|95.0|1.17|1.57|||||Calculated using Cox Proportional Hazard model.Reflects a comparison of incidence rates between participants diagnosed with Alopecia Areata (AA) and those without AA. Adjusted for sociodemographic,clinical characteristics and major comorbidities.|||1.57|1.17|
72595740|NCT05727306|144722922|OTHER||Hazard Ratio (HR)|1.46|||||TWO_SIDED|95.0|1.14|1.87|||||Calculated using Cox Proportional Hazard model.Reflects a comparison of incidence rates between participants diagnosed with Alopecia Areata (AA) and those without AA. Adjusted for sociodemographic,clinical characteristics and major comorbidities.|||1.87|1.14|
72595741|NCT05727306|144722923|OTHER||Hazard Ratio (HR)|1.49|||||TWO_SIDED|95.0|1.38|1.61|||||Calculated using Cox Proportional Hazard model.Reflects a comparison of incidence rates between participants diagnosed with Alopecia Areata (AA) and those without AA. Adjusted for sociodemographic,clinical characteristics and major comorbidities.|||1.61|1.38|
72595742|NCT05153148|144722932|SUPERIORITY||Risk Difference (RD)|5.9|||=|0.446|TWO_SIDED|95.0|-9.3|21.1|||Cochran-Mantel-Haenszel||Mantel-Haenszel (MH) risk difference was summarized along with the 2-sided 95% confidence interval (CI) using MH stratum weights and the Sato variance estimator.||Comparisons of ACR20 responder rates at Week 12 were made independently between each dose group and the placebo group using two-sided MH tests stratified on randomization stratification factors: prior treatment with biologics or non-traditional disease-modifying antirheumatic drugs (DMARDs) and region.|21.1|-9.3|=0.446
72595743|NCT05153148|144722932|SUPERIORITY||Risk Difference (RD)|24.1|||=|0.002|TWO_SIDED|95.0|8.6|39.6|||Cochran-Mantel-Haenszel||MH risk difference was summarized along with the 2-sided 95% CI using MH stratum weights and the Sato variance estimator.||Comparisons of ACR20 responder rates at Week 12 were made independently between each dose group and the placebo group using two-sided MH tests stratified on randomization stratification factors: prior treatment with biologics or non-traditional DMARDs and region.|39.6|8.6|=0.002
72595744|NCT05153148|144722932|SUPERIORITY||Risk Difference (RD)|24.5|||=|0.002|TWO_SIDED|95.0|9.0|39.9|||Cochran-Mantel-Haenszel||MH risk difference was summarized along with the 2-sided 95% CI using MH stratum weights and the Sato variance estimator.||Comparisons of ACR20 responder rates at Week 12 were made independently between each dose group and the placebo group using two-sided MH tests stratified on randomization stratification factors: prior treatment with biologics or non-traditional DMARDs and region.|39.9|9.0|=0.002
72595745|NCT05153148|144722933|SUPERIORITY||Risk Difference (RD)|5.7|||=|0.312|TWO_SIDED|95.0|-5.3|16.6|||Cochran-Mantel-Haenszel||MH risk difference was summarized along with the 2-sided 95% CI using MH stratum weights and the Sato variance estimator.||Comparisons of ACR50 responder rates at Week 12 were made independently between each dose group and the placebo group using two-sided MH tests stratified on randomization stratification factors: prior treatment with biologics or non-traditional DMARDs and region.|16.6|-5.3|=0.312
72595746|NCT05153148|144722933|SUPERIORITY||Risk Difference (RD)|17.0|||=|0.005|TWO_SIDED|95.0|5.0|29.1|||Cochran-Mantel-Haenszel||MH risk difference was summarized along with the 2-sided 95% CI using MH stratum weights and the Sato variance estimator.||Comparisons of ACR50 responder rates at Week 12 were made independently between each dose group and the placebo group using two-sided MH tests stratified on randomization stratification factors: prior treatment with biologics or non-traditional DMARDs and region.|29.1|5.0|=0.005
72595747|NCT05153148|144722933|SUPERIORITY||Risk Difference (RD)|16.4|||=|0.009|TWO_SIDED|95.0|4.2|28.6|||Cochran-Mantel-Haenszel||MH risk difference was summarized along with the 2-sided 95% CI using MH stratum weights and the Sato variance estimator.||Comparisons of ACR50 responder rates at Week 12 were made independently between each dose group and the placebo group using two-sided MH tests stratified on randomization stratification factors: prior treatment with biologics or non-traditional DMARDs and region.|28.6|4.2|=0.009
72595748|NCT05153148|144722934|SUPERIORITY||Risk Difference (RD)|2.9|||=|0.532|TWO_SIDED|95.0|-6.6|12.7|||Fisher Exact||Comparisons of ACR70 responder rates at Week 12 were made independently between each dose group and the placebo group using Fischer's exact Method.|||12.7|-6.6|=0.532
72595749|NCT05153148|144722934|SUPERIORITY||Risk Difference (RD)|9.1|||=|0.101|TWO_SIDED|95.0|-1.0|20.1|||Fisher Exact||Comparisons of ACR70 responder rates at Week 12 were made independently between each dose group and the placebo group using Fischer's exact Method.|||20.1|-1.0|=0.101
72595750|NCT05153148|144722934|SUPERIORITY||Risk Difference (RD)|8.3|||=|0.158|TWO_SIDED|95.0|-1.7|19.4|||Fisher Exact||Comparisons of ACR70 responder rates at Week 12 were made independently between each dose group and the placebo group using Fischer's exact Method.|||19.4|-1.7|=0.158
72595751|NCT05153148|144722935|SUPERIORITY||Treatment Difference|-1.7|||=|0.268|TWO_SIDED|95.0|-4.8|1.3|||Mixed Model Repeated Measure (MMRM)||Point estimate and 95% CI were obtained from a MMRM model.||MMRM model included fixed effects for treatment group, visit, and treatment group-by-visit interaction, with baseline value and the randomization stratification factors (prior treatment with biologics or non-traditional DMARDs and region) as covariates, and the change from baseline as the dependent variable.|1.3|-4.8|=0.268
72595752|NCT05153148|144722935|SUPERIORITY||Treatment Difference|-3.0|||=|0.051|TWO_SIDED|95.0|-6.1|0.0|||MMRM||Point estimate and 95% CI were obtained from a MMRM model.||MMRM model included fixed effects for treatment group, visit, and treatment group-by-visit interaction, with baseline value and the randomization stratification factors (prior treatment with biologics or non-traditional DMARDs and region) as covariates, and the change from baseline as the dependent variable.|0.0|-6.1|=0.051
72595753|NCT05153148|144722935|SUPERIORITY||Treatment Difference|-2.5|||=|0.112|TWO_SIDED|95.0|-5.6|0.6|||MMRM||Point estimate and 95% CI were obtained from a MMRM model.||MMRM model included fixed effects for treatment group, visit, and treatment group-by-visit interaction, with baseline value and the randomization stratification factors (prior treatment with biologics or non-traditional DMARDs and region) as covariates, and the change from baseline as the dependent variable.|0.6|-5.6|=0.112
72595754|NCT05153148|144722936|SUPERIORITY||Treatment Difference|-0.9|||=|0.28|TWO_SIDED|95.0|-2.4|0.7|||MMRM||Point estimate and 95% CI were obtained from a MMRM model.||MMRM model included fixed effects for treatment group, visit, and treatment group-by-visit interaction, with baseline value and the randomization stratification factors (prior treatment with biologics or non-traditional DMARDs and region) as covariates, and the change from baseline as the dependent variable.|0.7|-2.4|=0.280
72595755|NCT05153148|144722936|SUPERIORITY||Treatment Difference|-1.1|||=|0.177|TWO_SIDED|95.0|-2.6|0.5|||MMRM||Point estimate and 95% CI were obtained from a MMRM model.||MMRM model included fixed effects for treatment group, visit, and treatment group-by-visit interaction, with baseline value and the randomization stratification factors (prior treatment with biologics or non-traditional DMARDs and region) as covariates, and the change from baseline as the dependent variable.|0.5|-2.6|=0.177
72595756|NCT05153148|144722936|SUPERIORITY||Treatment Difference|-1.0|||=|0.196|TWO_SIDED|95.0|-2.6|0.5|||MMRM||Point estimate and 95% CI were obtained from a MMRM model.||MMRM model included fixed effects for treatment group, visit, and treatment group-by-visit interaction, with baseline value and the randomization stratification factors (prior treatment with biologics or non-traditional DMARDs and region) as covariates, and the change from baseline as the dependent variable.|0.5|-2.6|=0.196
72595757|NCT05153148|144722937|SUPERIORITY||Treatment Difference|-1.9|||=|0.637|TWO_SIDED|95.0|-9.6|5.9|||MMRM||Point estimate and 95% CI were obtained from a MMRM model.||MMRM model included fixed effects for treatment group, visit, and treatment group-by-visit interaction, with baseline value and the randomization stratification factors (prior treatment with biologics or non-traditional DMARDs and region) as covariates, and the change from baseline as the dependent variable.|5.9|-9.6|=0.637
72595758|NCT05153148|144722937|SUPERIORITY||Treatment Difference|-9.2|||=|0.021|TWO_SIDED|95.0|-17.0|-1.4|||MMRM||Point estimate and 95% CI were obtained from a MMRM model.||MMRM model included fixed effects for treatment group, visit, and treatment group-by-visit interaction, with baseline value and the randomization stratification factors (prior treatment with biologics or non-traditional DMARDs and region) as covariates, and the change from baseline as the dependent variable.|-1.4|-17.0|=0.021
72595759|NCT05153148|144722937|SUPERIORITY||Treatment Difference|-8.7|||=|0.03|TWO_SIDED|95.0|-16.5|-0.9|||MMRM||Point estimate and 95% CI were obtained from a MMRM model.||MMRM model included fixed effects for treatment group, visit, and treatment group-by-visit interaction, with baseline value and the randomization stratification factors (prior treatment with biologics or non-traditional DMARDs and region) as covariates, and the change from baseline as the dependent variable.|-0.9|-16.5|=0.030
72595760|NCT05153148|144722938|SUPERIORITY||Treatment Difference|-0.9|||=|0.812|TWO_SIDED|95.0|-8.4|6.6|||MMRM||Point estimate and 95% CI were obtained from a MMRM model.||MMRM model included fixed effects for treatment group, visit, and treatment group-by-visit interaction, with baseline value and the randomization stratification factors (prior treatment with biologics or non-traditional DMARDs and region) as covariates, and the change from baseline as the dependent variable.|6.6|-8.4|=0.812
72595761|NCT05153148|144722938|SUPERIORITY||Treatment Difference|-6.7|||=|0.079|TWO_SIDED|95.0|-14.2|0.8|||MMRM||Point estimate and 95% CI were obtained from a MMRM model.||MMRM model included fixed effects for treatment group, visit, and treatment group-by-visit interaction, with baseline value and the randomization stratification factors (prior treatment with biologics or non-traditional DMARDs and region) as covariates, and the change from baseline as the dependent variable.|0.8|-14.2|=0.079
72415191|NCT02207816|144340664|SUPERIORITY||Vaccine efficacy|-24.3||||1|TWO_SIDED|95.0|-526.0|73.3|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) was estimated as 1-the risk ratio (RR; proportion of subjects reporting events in the GSK257049 \[5-17M\] Group over the proportion in VeroRab Comparator \[5-17M\] Group), from Month 0 (study start of Malaria-055) to Year 3 (study end of Malaria-076).||73.30|-526|1.0000
72415192|NCT02207816|144340664|SUPERIORITY||Vaccine efficacy|-77.1||||0.3834|TWO_SIDED|95.0|-725.0|55.0|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) was estimated as 1-the risk ratio (RR; proportion of subjects reporting events in the GSK257049 Comparator \[5-17M\] Group over the proportion in VeroRab Comparator \[5-17M\] Group), from Month 0 (study start of Malaria-055) to Year 3 (study end of Malaria-076).||55.00|-725|0.3834
72415193|NCT02207816|144340664|SUPERIORITY||Vaccine efficacy|-297.5||||0.374|TWO_SIDED|95.0|-19000.0|60.7|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) was estimated as 1-the risk ratio (RR; proportion of subjects reporting events in the GSK257049 \[6-12W\] Group over the proportion in Menjugate Comparator \[6-12W\] Group), from Month 0 (study start of Malaria-055) to Year 3 (study end of Malaria-076).||60.70|-19000|0.3740
72415194|NCT02207816|144340664|SUPERIORITY||Vaccine efficacy|-498.1||||0.124|TWO_SIDED|95.0|-27000.0|27.4|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) was estimated as 1-the risk ratio (RR; proportion of subjects reporting events in the GSK257049 Comparator \[6-12W\] Group over the proportion in Menjugate Comparator \[6-12W\] Group), from Month 0 (study start of Malaria-055) to Year 3 (study end of Malaria-076).||27.40|-27000|0.1240
72415195|NCT05912400|144340669|OTHER||||||<|0.01||||||Spearman's rho was used to analyze correlation between OCR (Oxygen Consumption Rate) and NRS-11 Current (Numeric Pain Rating Scale for current pain).|Spearman's Rho|||||||<0.01
72415196|NCT05912400|144340669|OTHER|||||||0.02|||||||Spearman's Rho|Spearman's rho was used to analyze correlation between OCR (Oxygen Consumption Rate) and NRS-11 Best (Numeric Pain Rating Scale for best pain).||||||0.02
72415197|NCT05912400|144340669|OTHER|||||||0.03|||||||Spearman's Rho|Spearman's rho was used to analyze correlation between OCR (Oxygen Consumption Rate) and NRS-11 Worst (Numeric Pain Rating Scale for worst pain).||||||0.03
72415198|NCT05912400|144340669|OTHER|||||||0.88|||||||Spearman's Rho|Correlation: OCR (Oxygen Consumption Rate) and FACIT-F TOI (Functional Assessment of Chronic Illness Therapy - Fatigue, Trial Outcome Index)||||||0.88
72415199|NCT05912400|144340669|OTHER|||||||0.36|||||||Spearman's Rho|Spearman's rho was used to analyze correlation between OCR (Oxygen Consumption Rate) and vitamin D levels.||||||0.36
72415200|NCT05912400|144340670|OTHER|||||||0.54|||||||Spearman's Rho|Spearman's rho used analyze correlation btwn ECAR (Extracellular Acidification Rate) and NRS-11 Current (Numeric Pain Rating Scale for current pain)||||||0.54
72415201|NCT05912400|144340670|OTHER|||||||0.36|||||||Spearman's Rho|Spearman's rho used to analyze correlation between ECAR (Extracellular Acidification Rate) and NRS-11 Best (Numeric Pain Rating Scale for best pain).||||||0.36
72415202|NCT05912400|144340670|OTHER|||||||0.94|||||||Spearman's Rho|Spearman's rho used to analyze correlation between ECAR (Extracellular Acidification Rate) \& NRS-11 Worst (Numeric Pain Rating Scale for worst pain).||||||0.94
72415203|NCT05912400|144340670|OTHER|||||||0.53|||||||Spearman's Rho|Correlation: ECAR (Extracellular Acidification Rate) \& FACIT-F TOI (Functional Assessment of Chronic Illness Therapy - Fatigue, Trial Outcome Index).||||||0.53
72415204|NCT05912400|144340670|OTHER|||||||0.51|||||||Spearman's Rho|Spearman's rho was used to analyze correlation between ECAR (Extracellular Acidification Rate) and vitamin D levels.||||||0.51
72415205|NCT05912400|144340671|OTHER|||||||0.36|||||||Spearman's Rho|Spearman's rho was used to analyze correlation between OCR (Oxygen Consumption Rate) and vitamin D levels.||||||0.36
72415206|NCT05912400|144340671|OTHER|||||||0.51|||||||Spearman's Rho|Spearman's rho was used to analyze correlation between ECAR (Extracellular Acidification Rate) and vitamin D levels.||||||0.51
72415207|NCT05912400|144340672|OTHER||||||<|0.01|||||||Spearman's Rho|Spearman's rho was used to analyze correlation between OCR (Oxygen Consumption Rate) and NRS-11 Current (Numeric Pain Rating Scale for current pain).||||||<0.01
72415208|NCT05912400|144340672|OTHER|||||||0.54|||||||Spearman's Rho|Spearman's rho used analyze correlation between ECAR (Extracellular Acidification Rate) \& NRS-11 Current (Numeric Pain Rating Scale for current pain).||||||0.54
72415209|NCT05912400|144340673|OTHER|||||||0.02|||||||Spearman's Rho|Spearman's rho was used to analyze correlation between OCR (Oxygen Consumption Rate) and NRS-11 Best (Numeric Pain Rating Scale for best pain).||||||0.02
72415210|NCT05912400|144340673|OTHER|||||||0.36|||||||Spearman's Rho|Spearman's rho used to analyze correlation between ECAR (Extracellular Acidification Rate) and NRS-11 Best (Numeric Pain Rating Scale for best pain).||||||0.36
72415211|NCT05912400|144340674|OTHER|||||||0.03|||||||Spearman's Rho|Spearman's rho was used to analyze correlation between OCR (Oxygen Consumption Rate) and NRS-11 Worst (Numeric Pain Rating Scale for worst pain).||||||0.03
72415212|NCT05912400|144340674|OTHER|||||||0.94|||||||Spearman's Rho|Spearman's rho used to analyze correlation between ECAR (Extracellular Acidification Rate) \& NRS-11 Worst (Numeric Pain Rating Scale for worst pain).||||||0.94
72415213|NCT05912400|144340675|OTHER|||||||0.88|||||||Spearman's Rho|Correlation: OCR (Oxygen Consumption Rate) and FACIT-F TOI (Functional Assessment of Chronic Illness Therapy - Fatigue, Trial Outcome Index).||||||0.88
72415214|NCT05912400|144340675|OTHER|||||||0.53|||||||Spearman's Rho|Correlation: ECAR (Extracellular Acidification Rate) \& FACIT-F TOI (Functional Assessment of Chronic Illness Therapy - Fatigue, Trial Outcome Index).||||||0.53
72415215|NCT03248739|144340692|EQUIVALENCE|Based on occlusion data from the previously referenced prospective study, as well as a P-value of 0.05 and power of 0.80, the study will need to include 90 patients to demonstrate statistical significance. To ensure that power is adequate, we will plan to enroll 120 patients (60 in each arm).||||||0.23|||||||Fisher Exact|||||||0.23
72415216|NCT01227681|144340706|SUPERIORITY_OR_OTHER|||||||0.64|||||||t-test, 2 sided|||Null hypothesis: there is significant deterioration of UPDRS part III scores from baseline to post G-CSF injection one year||||0.64
72415217|NCT02239679|144340707|SUPERIORITY|||||||0.0166|||||||ANCOVA|||||||0.0166
72415218|NCT02239679|144340713|SUPERIORITY|||||||0.0102||||||no adjustments for multiple comparisons|Cochran-Mantel-Haenszel|stratified by site||||||0.0102
72415219|NCT02239679|144340713|SUPERIORITY|||||||0.0089||||||no adjustment for multiple comparisons|Cochran-Mantel-Haenszel|stratified by site||||||0.0089
72415220|NCT02239679|144340714|SUPERIORITY|||||||0.0004||||||no adjustments for multiple comparisons|Cochran-Mantel-Haenszel|stratified by site||||||0.0004
72415221|NCT02239679|144340714|SUPERIORITY||||||<|0.0001||||||no adjustment for multiple comparison|Cochran-Mantel-Haenszel|stratified by site||||||<0.0001
72415222|NCT00373334|144340809|SUPERIORITY_OR_OTHER|||||||0.528||95.0|||||Cochran-Mantel-Haenszel|||||||0.528
72415223|NCT00373334|144340809|SUPERIORITY_OR_OTHER|||||||0.341||95.0|||||Cochran-Mantel-Haenszel|||||||0.341
72415224|NCT00373334|144340810|SUPERIORITY_OR_OTHER|||||||0.746||95.0|||||Chi-squared|||Comparison of nizatidine 2.5 group to placebo group. P-value is for overall difference between groups (not comparison of individual categories).||||0.746
72415225|NCT00373334|144340810|SUPERIORITY_OR_OTHER|||||||0.262||95.0|||||Chi-squared|||Comparison of nizatidine 5.0 group to placebo group. P-value is for overall difference between groups (not comparison of individual categories).||||0.262
72415226|NCT00373334|144340811|SUPERIORITY_OR_OTHER|||||||0.609||95.0|||||Chi-squared|||Comparison of nizatidine 2.5 group to placebo group. P-value is for overall difference between groups (not comparison of individual categories).||||0.609
72415227|NCT00373334|144340811|SUPERIORITY_OR_OTHER|||||||0.938||95.0|||||Chi-squared|||Comparison of nizatidine 5.0 group to placebo group. P-value is for overall difference between groups (not comparison of individual categories).||||0.938
72415228|NCT00121238|144340916|SUPERIORITY_OR_OTHER|||||||0.27|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.27
72595762|NCT05153148|144722938|SUPERIORITY||Treatment Difference|-6.3|||=|0.102|TWO_SIDED|95.0|-13.9|1.3|||MMRM||Point estimate and 95% CI were obtained from a MMRM model.||MMRM model included fixed effects for treatment group, visit, and treatment group-by-visit interaction, with baseline value and the randomization stratification factors (prior treatment with biologics or non-traditional DMARDs and region) as covariates, and the change from baseline as the dependent variable.|1.3|-13.9|=0.102
72595763|NCT05153148|144722939|SUPERIORITY||Treatment Difference|-8.9|||=|0.016|TWO_SIDED|95.0|-16.2|-1.7|||MMRM||Point estimate and 95% CI were obtained from a MMRM model.||MMRM model included fixed effects for treatment group, visit, and treatment group-by-visit interaction, with baseline value and the randomization stratification factors (prior treatment with biologics or non-traditional DMARDs and region) as covariates, and the change from baseline as the dependent variable.|-1.7|-16.2|=0.016
72595764|NCT05153148|144722939|SUPERIORITY||Treatment Difference|-10.6|||=|0.004|TWO_SIDED|95.0|-17.8|-3.4|||MMRM||Point estimate and 95% CI were obtained from a MMRM model.||MMRM model included fixed effects for treatment group, visit, and treatment group-by-visit interaction, with baseline value and the randomization stratification factors (prior treatment with biologics or non-traditional DMARDs and region) as covariates, and the change from baseline as the dependent variable.|-3.4|-17.8|=0.004
72595765|NCT05153148|144722939|SUPERIORITY||Treatment Difference|-10.9|||=|0.003|TWO_SIDED|95.0|-18.2|-3.6|||MMRM||Point estimate and 95% CI were obtained from a MMRM model.||MMRM model included fixed effects for treatment group, visit, and treatment group-by-visit interaction, with baseline value and the randomization stratification factors (prior treatment with biologics or non-traditional DMARDs and region) as covariates, and the change from baseline as the dependent variable.|-3.6|-18.2|=0.003
72595766|NCT05153148|144722940|SUPERIORITY||Treatment Difference|-0.07|||=|0.357|TWO_SIDED|95.0|-0.21|0.08|||MMRM||Point estimate and 95% CI were obtained from a MMRM model.||MMRM model included fixed effects for treatment group, visit, and treatment group-by-visit interaction, with baseline value and the randomization stratification factors (prior treatment with biologics or non-traditional DMARDs and region) as covariates, and the change from baseline as the dependent variable.|0.08|-0.21|=0.357
72595767|NCT05153148|144722940|SUPERIORITY||Treatment Difference|-0.1|||=|0.195|TWO_SIDED|95.0|-0.24|0.05|||MMRM||Point estimate and 95% CI were obtained from a MMRM model.||MMRM model included fixed effects for treatment group, visit, and treatment group-by-visit interaction, with baseline value and the randomization stratification factors (prior treatment with biologics or non-traditional DMARDs and region) as covariates, and the change from baseline as the dependent variable.|0.05|-0.24|=0.195
72595768|NCT05153148|144722940|SUPERIORITY||Treatment Difference|-0.05|||=|0.467|TWO_SIDED|95.0|-0.2|0.09|||MMRM||Point estimate and 95% CI were obtained from a MMRM model.||MMRM model included fixed effects for treatment group, visit, and treatment group-by-visit interaction, with baseline value and the randomization stratification factors (prior treatment with biologics or non-traditional DMARDs and region) as covariates, and the change from baseline as the dependent variable.|0.09|-0.20|=0.467
72595769|NCT05153148|144722941|SUPERIORITY||Treatment Difference|1.3|||=|0.031|TWO_SIDED|95.0|0.1|2.4|||MMRM||Point estimate and 95% CI were obtained from a MMRM model.||MMRM model included fixed effects for treatment group, visit, and treatment group-by-visit interaction, with baseline value and the randomization stratification factors (prior treatment with biologics or non-traditional DMARDs and region) as covariates, and the change from baseline as the dependent variable.|2.4|0.1|=0.031
72595770|NCT05153148|144722941|SUPERIORITY||Treatment Difference|0.1|||=|0.86|TWO_SIDED|95.0|-1.1|1.3|||MMRM||Point estimate and 95% CI were obtained from a MMRM model.||MMRM model included fixed effects for treatment group, visit, and treatment group-by-visit interaction, with baseline value and the randomization stratification factors (prior treatment with biologics or non-traditional DMARDs and region) as covariates, and the change from baseline as the dependent variable.|1.3|-1.1|=0.860
72595771|NCT05153148|144722941|SUPERIORITY||Treatment Difference|0.2|||=|0.758|TWO_SIDED|95.0|-0.9|1.3|||MMRM||Point estimate and 95% CI were obtained from a MMRM model.||MMRM model included fixed effects for treatment group, visit, and treatment group-by-visit interaction, with baseline value and the randomization stratification factors (prior treatment with biologics or non-traditional DMARDs and region) as covariates, and the change from baseline as the dependent variable.|1.3|-0.9|=0.758
72595772|NCT05153148|144722942|SUPERIORITY||Treatment Difference|-0.5|||=|0.131|TWO_SIDED|95.0|-1.2|0.2|||MMRM||Point estimate and 95% CI were obtained from a MMRM model.||MMRM model included fixed effects for treatment group, visit, and treatment group-by-visit interaction, with baseline value and the randomization stratification factors (prior treatment with biologics or non-traditional DMARDs and region) as covariates, and the change from baseline as the dependent variable.|0.2|-1.2|=0.131
72595773|NCT05153148|144722942|SUPERIORITY||Treatment Difference|-0.7|||=|0.043|TWO_SIDED|95.0|-1.3|0.0|||MMRM||Point estimate and 95% CI were obtained from a MMRM model.||MMRM model included fixed effects for treatment group, visit, and treatment group-by-visit interaction, with baseline value and the randomization stratification factors (prior treatment with biologics or non-traditional DMARDs and region) as covariates, and the change from baseline as the dependent variable.|0.0|-1.3|=0.043
72595774|NCT05153148|144722942|SUPERIORITY||Treatment Difference|-0.1|||=|0.687|TWO_SIDED|95.0|-0.8|0.5|||MMRM||Point estimate and 95% CI were obtained from a MMRM model.||MMRM model included fixed effects for treatment group, visit, and treatment group-by-visit interaction, with baseline value and the randomization stratification factors (prior treatment with biologics or non-traditional DMARDs and region) as covariates, and the change from baseline as the dependent variable.|0.5|-0.8|=0.687
72595775|NCT05153148|144722943|SUPERIORITY||Risk Difference (RD)|5.6|||=|0.349|TWO_SIDED|95.0|-6.1|17.4|||Cochran-Mantel-Haenszel||MH risk difference was summarized along with the 2-sided 95% CI using MH stratum weights and the Sato variance estimator.||Comparisons of MDA responder rates at Week 12 were made independently between each dose group and the placebo group using two-sided MH tests stratified on randomization stratification factors: prior treatment with biologics or non-traditional DMARDs and region.|17.4|-6.1|=0.349
72595776|NCT05153148|144722943|SUPERIORITY||Risk Difference (RD)|15.5|||=|0.017|TWO_SIDED|95.0|2.8|28.3|||Cochran-Mantel-Haenszel||MH risk difference was summarized along with the 2-sided 95% CI using MH stratum weights and the Sato variance estimator.||Comparisons of MDA responder rates at Week 12 were made independently between each dose group and the placebo group using two-sided MH tests stratified on randomization stratification factors: prior treatment with biologics or non-traditional DMARDs and region.|28.3|2.8|=0.017
72595777|NCT05153148|144722943|SUPERIORITY||Risk Difference (RD)|16.3|||=|0.014|TWO_SIDED|95.0|3.3|29.3|||Cochran-Mantel-Haenszel||MH risk difference was summarized along with the 2-sided 95% CI using MH stratum weights and the Sato variance estimator.||Comparisons of MDA responder rates at Week 12 were made independently between each dose group and the placebo group using two-sided MH tests stratified on randomization stratification factors: prior treatment with biologics or non-traditional DMARDs and region.|29.3|3.3|=0.014
72595778|NCT05153148|144722944|SUPERIORITY||Treatment Difference|-3.73|||=|0.167|TWO_SIDED|95.0|-9.04|1.57|||MMRM||Point estimate and 95% CI were obtained from a MMRM model.||MMRM model included fixed effects for treatment group, visit, and treatment group-by-visit interaction, with baseline value and the randomization stratification factors (prior treatment with biologics or non-traditional DMARDs and region) as covariates, and the change from baseline as the dependent variable.|1.57|-9.04|=0.167
72595779|NCT05153148|144722944|SUPERIORITY||Treatment Difference|-6.43|||=|0.018|TWO_SIDED|95.0|-11.73|-1.13|||MMRM||Point estimate and 95% CI were obtained from a MMRM model.||MMRM model included fixed effects for treatment group, visit, and treatment group-by-visit interaction, with baseline value and the randomization stratification factors (prior treatment with biologics or non-traditional DMARDs and region) as covariates, and the change from baseline as the dependent variable.|-1.13|-11.73|=0.018
72595780|NCT05153148|144722944|SUPERIORITY||Treatment Difference|-5.23|||=|0.056|TWO_SIDED|95.0|-10.59|0.13|||MMRM||Point estimate and 95% CI were obtained from a MMRM model.||MMRM model included fixed effects for treatment group, visit, and treatment group-by-visit interaction, with baseline value and the randomization stratification factors (prior treatment with biologics or non-traditional DMARDs and region) as covariates, and the change from baseline as the dependent variable.|0.13|-10.59|=0.056
72595781|NCT05153148|144722945|SUPERIORITY||Risk Difference (RD)|11.9|||=|0.186|TWO_SIDED|95.0|-5.7|29.4|||Cochran-Mantel-Haenszel||MH risk difference was summarized along with the 2-sided 95% CI using MH stratum weights and the Sato variance estimator.||Comparisons of PASI-75 responder rates at Week 12 were made independently between each dose group and the placebo group using two-sided MH tests stratified on randomization stratification factors: prior treatment with biologics or non-traditional DMARDs and region.|29.4|-5.7|=0.186
72595782|NCT05153148|144722945|SUPERIORITY||Risk Difference (RD)|14.6|||=|0.101|TWO_SIDED|95.0|-2.8|32.1|||Cochran-Mantel-Haenszel||MH risk difference was summarized along with the 2-sided 95% CI using MH stratum weights and the Sato variance estimator.||Comparisons of PASI-75 responder rates at Week 12 were made independently between each dose group and the placebo group using two-sided MH tests stratified on randomization stratification factors: prior treatment with biologics or non-traditional DMARDs and region.|32.1|-2.8|=0.101
72595783|NCT05153148|144722945|SUPERIORITY||Risk Difference (RD)|29.0|||=|0.002|TWO_SIDED|95.0|10.5|47.6|||Cochran-Mantel-Haenszel||MH risk difference was summarized along with the 2-sided 95% CI using MH stratum weights and the Sato variance estimator.||Comparisons of PASI-75 responder rates at Week 12 were made independently between each dose group and the placebo group using two-sided MH tests stratified on randomization stratification factors: prior treatment with biologics or non-traditional DMARDs and region.|47.6|10.5|=0.002
72595784|NCT05153148|144722946|SUPERIORITY||Risk Difference (RD)|4.5|||=|0.54|TWO_SIDED|95.0|-10.0|19.0|||Cochran-Mantel-Haenszel||MH risk difference was summarized along with the 2-sided 95% CI using MH stratum weights and the Sato variance estimator.||Comparisons of PhGA-PSO responder rates at Week 12 were made independently between each dose group and the placebo group using two-sided MH tests stratified on randomization stratification factors: prior treatment with biologics or non-traditional DMARDs and region.|19.0|-10.0|=0.540
72595785|NCT05153148|144722946|SUPERIORITY||Risk Difference (RD)|5.2|||=|0.466|TWO_SIDED|95.0|-8.8|19.3|||Cochran-Mantel-Haenszel||MH risk difference was summarized along with the 2-sided 95% CI using MH stratum weights and the Sato variance estimator.||Comparisons of PhGA-PSO responder rates at Week 12 were made independently between each dose group and the placebo group using two-sided MH tests stratified on randomization stratification factors: prior treatment with biologics or non-traditional DMARDs and region.|19.3|-8.8|=0.466
72595786|NCT05153148|144722946|SUPERIORITY||Risk Difference (RD)|16.3|||=|0.034|TWO_SIDED|95.0|1.2|31.3|||Cochran-Mantel-Haenszel||MH risk difference was summarized along with the 2-sided 95% CI using MH stratum weights and the Sato variance estimator.||Comparisons of PhGA-PSO responder rates at Week 12 were made independently between each dose group and the placebo group using two-sided MH tests stratified on randomization stratification factors: prior treatment with biologics or non-traditional DMARDs and region.|31.3|1.2|=0.034
72595787|NCT00232596|144722953|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Non-parametric rank analysis of covariance adjusted for baseline 28-seizure frequency and stratified by baseline seizure frequency category and region|Non-parametric rank ANCOVA|||||||<0.001
72595788|NCT00232596|144722954|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Fisher Exact|||||||<0.001
72595789|NCT01712334|144722973|NON_INFERIORITY_OR_EQUIVALENCE|The ratio of the mean percent predicted FEV1 at the end of the eRapid treatment to the mean percent predicted FEV1 at the end of the LC Plus jet nebulizer treatment. The two nebulizers were considered equivalent if the 90% CI was within 80%-125%.|Ratio (Fieller's theorem)|100.9|||||TWO_SIDED|90.0|99.5|102.3||||||||102.3|99.5|
72595790|NCT01953432|144722975|OTHER||Odds Ratio (OR)|0.75|||||TWO_SIDED||||||||Probability of 0.75 that the OR exceeded 1.00 (OR = 1.01, 95% CI = 0.98-1.05)|||||
72595791|NCT01953432|144722975|OTHER||Odds Ratio (OR)|0.96|||||TWO_SIDED||||||||Probability of 0.96 that the odds ratio exceeded 1.00 (OR = 1.03, 95% CI = 1.00-1.07)|||||
72595792|NCT01253174|144722976|NON_INFERIORITY_OR_EQUIVALENCE|A sample size of 6 volunteers per sequence was considered sufficient to establish bioequivalence, id est the 90%-confidence interval for the mean ratio is located completely within the equivalence interval limits of 80% and 125%.|mean ratio|102.26||||||90.0|96.65|108.2||The equivalence test was done using a 90% confidence interval, no p-value was to be calculated.|ANOVA||Point estimate for the ratio \[(EE30/DRSP/L-5-MTHF Ca) / Yasmin\]. Bioequivalence is established if the 90% confidence interval fall within the equivalence interval limits of 80-125%|41 volunteers qualified for statistical analysis of BE whereas all 42 volunteers with valid concentration time profiles were included in the pharmacokinetic (PK) analysis||108.20|96.65|
72595793|NCT01253174|144722977|NON_INFERIORITY_OR_EQUIVALENCE|A sample size of 6 volunteers per sequence was considered sufficient to establish bioequivalence, id est the 90%-confidence interval for the mean ratio is located completely within the equivalence interval limits of 80% and 125%.|mean ratio|101.13||||||90.0|97.65|104.75||The equivalence test was done using a 90% confidence interval, no p-value was to be calculated.|ANOVA||Point estimate for the ratio \[(EE30/DRSP/L-5-MTHF Ca) / Yasmin\]. Bioequivalence is established if the 90% confidence interval fall within the equivalence interval limits of 80-125%|41 volunteers qualified for statistical analysis of BE whereas all 42 volunteers with valid concentration time profiles were included in the pharmacokinetic (PK) analysis||104.75|97.65|
72595794|NCT01253174|144722978|NON_INFERIORITY_OR_EQUIVALENCE|A sample size of 6 volunteers per sequence was considered sufficient to establish bioequivalence, id est the 90%-confidence interval for the mean ratio is located completely within the equivalence interval limits of 80% and 125%.|mean ratio|98.66||||||90.0|93.37|104.24||The equivalence test was done using a 90% confidence interval, no p-value was to be calculated.|ANOVA||Point estimate for the ratio \[(EE30/DRSP/L-5-MTHF Ca) / Yasmin\]. Bioequivalence is established if the 90% confidence interval fall within the equivalence interval limits of 80-125%|39 volunteers qualified for statistical analysis of BE whereas all 40 volunteers with valid concentration time profiles were included in the pharmacokinetic (PK) analysis||104.24|93.37|
72595795|NCT01253174|144722979|NON_INFERIORITY_OR_EQUIVALENCE|A sample size of 6 volunteers per sequence was considered sufficient to establish bioequivalence, id est the 90%-confidence interval for the mean ratio is located completely within the equivalence interval limits of 80% and 125%.|mean ratio|99.45||||||90.0|96.7|102.28||The equivalence test was done using a 90% confidence interval, no p-value was to be calculated.|ANOVA||Point estimate for the ratio \[(EE30/DRSP/L-5-MTHF Ca) / Yasmin\]. Bioequivalence is established if the 90% confidence interval fall within the equivalence interval limits of 80-125%|39 volunteers qualified for statistical analysis of BE whereas all 40 volunteers with valid concentration time profiles were included in the pharmacokinetic (PK) analysis||102.28|96.70|
72595796|NCT01253174|144722980|NON_INFERIORITY_OR_EQUIVALENCE|A sample size of 6 volunteers per sequence was considered sufficient to establish bioequivalence, id est the 90%-confidence interval for the mean ratio is located completely within the equivalence interval limits of 80% and 125%.|mean ratio|106.19||||||90.0|99.18|113.68||The equivalence test was done using a 90% confidence interval, no p-value was to be calculated.|ANOVA||Point estimate for the ratio \[(EE30/DRSP/L-5-MTHF Ca) / Metafolin\]. Bioequivalence is established if the 90% confidence interval fall within the equivalence interval limits of 80-125%|41 volunteers qualified for statistical analysis of BE whereas all 41 (EE30/DRSP/L-5-MTHF Ca) and 43 (Metafolin) volunteers with valid concentration time profiles were included in the pharmacokinetic (PK) analysis||113.68|99.18|
72415229|NCT00845663|144340950|NON_INFERIORITY_OR_EQUIVALENCE|Use of the 80-125 % bioequivalence range. If 90% confidence interval for ratio of geometric LS Means (percent) is included within these limits, the devices are considered bioequivalent.|ratio of geometric LS Means (percent)|101.33||||||90.0|92.84|110.58|||ANOVA|ANOVA for log-transformed values with treatment as factor has been used as the basis for calculation of estimated value and confidence interval.|Ratio is Auto-injection device/Pre-filled syringe|Bioequivalence testing by using the 90% Confidence Interval||110.58|92.84|
72415230|NCT00845663|144340951|NON_INFERIORITY_OR_EQUIVALENCE|Use of the 80-125% bioequivalence range. If 90% confidence interval for ratio of geometric LS Means (percent) is included within these limits, the devices are considered bioequivalent.|ratio of geometric LS Means (percent)|97.7||||||90.0|89.06|107.19|||ANOVA|ANOVA for log-transformed values with treatment as factor was taken as the basis for calculation of estimated value and confidence interval.|Ratio is Auto-injection device/Pre-filled syringe|Bioequivalence testing by using the 90% Confidence Interval||107.19|89.06|
72415231|NCT00845663|144340952|NON_INFERIORITY_OR_EQUIVALENCE|Use of the 80-125 % bioequivalence range. If 90% confidence interval for ratio of geometric LS Means (percent) is included within these limits, the devices are considered bioequivalent.|ratio of geometric LS Means (percent)|97.54||||||90.0|87.33|108.94|||ANOVA|ANOVA for log-transformed values with treatment as factor was taken as a basis for calculation of estimated value and the confidence interval.|Ratio is Auto-injection device/Pre-filled syringe|Bioequivalence testing by using the 90% Confidence Interval||108.94|87.33|
72415232|NCT05585307|144340998|SUPERIORITY||||||<|0.0001||||||P-value was calculated from two-sided t-test.|t-test, 2 sided|||||||<0.0001
72415233|NCT05585307|144340998|SUPERIORITY||||||<|0.0001||||||P-value was calculated from two-sided t-test.|t-test, 2 sided|||||||<0.0001
72415234|NCT05585307|144340998|SUPERIORITY|||||||0.0013||||||P-value was calculated from two-sided t-test.|t-test, 2 sided|||||||0.0013
72415235|NCT05585307|144340998|SUPERIORITY||||||<|0.0001||||||P-value was calculated from two-sided t-test.|t-test, 2 sided|||||||<0.0001
72415236|NCT05585307|144340998|SUPERIORITY||||||<|0.0001||||||P-value was calculated from two-sided t-test.|t-test, 2 sided|||||||<0.0001
72415237|NCT05585307|144340998|SUPERIORITY||||||<|0.0001||||||P-value was calculated from two-sided t-test.|t-test, 2 sided|||||||<0.0001
72415238|NCT05585307|144340998|SUPERIORITY||||||<|0.0001||||||P-value was calculated from two-sided t-test.|t-test, 2 sided|||||||<0.0001
72415239|NCT05585307|144340998|SUPERIORITY||||||<|0.0001||||||P-value was calculated from two-sided t-test.|t-test, 2 sided|||||||<0.0001
72415240|NCT05585307|144340999|SUPERIORITY||||||<|0.0001||||||P-value was calculated from two-sided t-test.|t-test, 2 sided|||||||<0.0001
72415241|NCT05585307|144340999|SUPERIORITY||||||<|0.0001||||||P-value was calculated from two-sided t-test.|t-test, 2 sided|||||||<0.0001
72415242|NCT05585307|144340999|SUPERIORITY||||||<|0.0001||||||P-value was calculated from two-sided t-test.|t-test, 2 sided|||||||<0.0001
72415243|NCT05585307|144340999|SUPERIORITY||||||<|0.0001||||||P-value was calculated from two-sided t-test.|t-test, 2 sided|||||||<0.0001
72415244|NCT05585307|144340999|SUPERIORITY||||||<|0.0001||||||P-value was calculated from two-sided t-test.|t-test, 2 sided|||||||<0.0001
72415245|NCT05585307|144340999|SUPERIORITY||||||<|0.0001||||||P-value was calculated from two-sided t-test.|t-test, 2 sided|||||||<0.0001
72415246|NCT05585307|144340999|SUPERIORITY||||||<|0.0001||||||P-value was calculated from two-sided t-test.|t-test, 2 sided|||||||<0.0001
72415247|NCT05585307|144340999|SUPERIORITY||||||<|0.0001||||||P-value was calculated from two-sided t-test.|t-test, 2 sided|||||||<0.0001
72415248|NCT04642638|144341019|OTHER||Difference in median|6.7|STANDARD_ERROR_OF_MEAN|3.35|||TWO_SIDED|95.0|0.0|6.7|||||Post-baseline change from baseline in IFN-gamma ELISpot response magnitudes was compared between groups using differences in medians and associated non-parametric 95% confidence interval (CI).|||6.70|0.00|
72415249|NCT04642638|144341019|OTHER||Difference in median|13.3|STANDARD_ERROR_OF_MEAN|10.55|||TWO_SIDED|95.0|3.3|17.8|||||Post-baseline change from baseline in IFN-gamma ELISpot response magnitudes was compared between groups using differences in medians and associated non-parametric 95% CI.|||17.80|3.30|
72415250|NCT04642638|144341019|OTHER||Difference in median|-6.6|STANDARD_ERROR_OF_MEAN|-5.0|||TWO_SIDED|95.0|-10.0|0.0|||||Post-baseline change from baseline in IFN-gamma ELISpot response magnitudes was compared between groups using differences in medians and associated non-parametric 95% CI.|||0.00|-10.00|
72415251|NCT04642638|144341020|OTHER||Geometric Mean Fold Rise (GMFR) Ratio|2.5|||||TWO_SIDED|95.0|1.72|3.632|||||95% CI of GMFR ratio is based on t-distribution, where GMFR ratio is based on the between-treatment-group comparisons.|||3.632|1.720|
72415252|NCT04642638|144341020|OTHER||GMFR Ratio|3.88|||||TWO_SIDED|95.0|2.638|5.7|||||95% CI of GMFR ratio is based on t-distribution, where GMFR ratio is based on the between-treatment-group comparisons.|||5.700|2.638|
72415253|NCT04642638|144341020|OTHER||GMFR Ratio|0.68|||||TWO_SIDED|95.0|0.512|0.893|||||95% CI of GMFR ratio is based on t-distribution, where GMFR ratio is based on the between-treatment-group comparisons|||0.893|0.512|
72415254|NCT04053764|144341048|SUPERIORITY||Odds Ratio (OR)|1.94|||||TWO_SIDED|95.0|0.53|7.14||||||||7.14|0.53|
72415255|NCT04053764|144341050|SUPERIORITY||Odds Ratio (OR)|0.73|||||TWO_SIDED|95.0|0.23|2.31||||||||2.31|0.23|
72415256|NCT04053764|144341051|SUPERIORITY||Odds Ratio (OR)|0.94|||||TWO_SIDED|95.0|0.29|3.02||||||PCR Improvement||3.02|0.29|
72415257|NCT04053764|144341051|SUPERIORITY||Odds Ratio (OR)|0.75|||||TWO_SIDED|95.0|0.18|3.2||||||Stable PCR||3.20|0.18|
72415258|NCT04053764|144341052|SUPERIORITY||Mean Difference (Final Values)|-0.44|STANDARD_ERROR_OF_MEAN|2.53|||TWO_SIDED|95.0|-5.53|4.65||||||From baseline to 3 months||4.65|-5.53|
72415259|NCT04053764|144341052|SUPERIORITY||Mean Difference (Final Values)|4.69|STANDARD_ERROR_OF_MEAN|3.32|||TWO_SIDED|95.0|-2.02|11.4||||||From baseline to 6 months||11.40|-2.02|
72415260|NCT04053764|144341052|SUPERIORITY||Mean Difference (Final Values)|4.05|STANDARD_ERROR_OF_MEAN|3.77|||TWO_SIDED|95.0|-3.58|11.68||||||From baseline to 9 months||11.68|-3.58|
72415261|NCT04053764|144341052|SUPERIORITY||Mean Difference (Final Values)|5.19|STANDARD_ERROR_OF_MEAN|4.17|||TWO_SIDED|95.0|-3.28|13.67||||||From baseline to 12 months||13.67|-3.28|
72415262|NCT04053764|144341055|SUPERIORITY||Odds Ratio (OR)|0.32|||||TWO_SIDED|95.0|0.09|1.21||||||||1.21|0.09|
72415263|NCT02935062|144341060|SUPERIORITY|||||||0.001|||||||t-test, 1 sided|||||||0.001
72415264|NCT02935062|144341061|SUPERIORITY|||||||0.011|||||||t-test, 1 sided|||||||0.011
72595797|NCT01253174|144722981|NON_INFERIORITY_OR_EQUIVALENCE|A sample size of 6 volunteers per sequence was considered sufficient to establish bioequivalence, id est the 90%-confidence interval for the mean ratio is located completely within the equivalence interval limits of 80% and 125%.|mean ratio|97.98||||||90.0|94.19|101.93||The equivalence test was done using a 90% confidence interval, no p-value was to be calculated.|ANOVA||Point estimate for the ratio \[(EE30/DRSP/L-5-MTHF Ca) / Metafolin\]. Bioequivalence is established if the 90% confidence interval fall within the equivalence interval limits of 80-125%|41 volunteers qualified for statistical analysis of BE whereas all 41 (EE30/DRSP/L-5-MTHF Ca) and 43 (Metafolin) volunteers with valid concentration time profiles were included in the pharmacokinetic (PK) analysis||101.93|94.19|
72595798|NCT01253174|144722982|NON_INFERIORITY_OR_EQUIVALENCE|A sample size of 6 volunteers per sequence was considered sufficient to establish bioequivalence, id est the 90%-confidence interval for the mean ratio is located completely within the equivalence interval limits of 80% and 125%.|mean ratio|104.9||||||90.0|98.83|111.34||The equivalence test was done using a 90% confidence interval, no p-value was to be calculated.|ANOVA||Point estimate for the ratio \[(EE30/DRSP/L-5-MTHF Ca) / Metafolin\]. Bioequivalence is established if the 90% confidence interval fall within the equivalence interval limits of 80-125%|41 volunteers qualified for statistical analysis of BE whereas all 41 (EE30/DRSP/L-5-MTHF Ca) and 43 (Metafolin) volunteers with valid concentration time profiles were included in the pharmacokinetic (PK) analysis||111.34|98.83|
72595799|NCT01253174|144722983|NON_INFERIORITY_OR_EQUIVALENCE|A sample size of 6 volunteers per sequence was considered sufficient to establish bioequivalence, id est the 90%-confidence interval for the mean ratio is located completely within the equivalence interval limits of 80% and 125%.|mean ratio|99.63||||||90.0|95.73|103.69||The equivalence test was done using a 90% confidence interval, no p-value was to be calculated.|ANOVA||Point estimate for the ratio \[(EE30/DRSP/L-5-MTHF Ca) / Metafolin\]. Bioequivalence is established if the 90% confidence interval fall within the equivalence interval limits of 80-125%|41 volunteers qualified for statistical analysis of BE whereas all 41 (EE30/DRSP/L-5-MTHF Ca) and 43 (Metafolin) volunteers with valid concentration time profiles were included in the pharmacokinetic (PK) analysis||103.69|95.73|
72595800|NCT01253174|144722985|NON_INFERIORITY_OR_EQUIVALENCE|A sample size of 6 volunteers per sequence was considered sufficient to establish bioequivalence, id est the 90%-confidence interval for the mean ratio is located completely within the equivalence interval limits of 80% and 125%.|mean ratio|99.57||||||90.0|97.32|101.87||The equivalence test was done using a 90% confidence interval, no p-value was to be calculated.|ANOVA||Point estimate for the ratio \[(EE30/DRSP/L-5-MTHF Ca) / Yasmin\]. Bioequivalence is established if the 90% confidence interval fall within the equivalence interval limits of 80-125%|38 volunteers qualified for statistical analysis of BE whereas all 40 volunteers with valid concentration time profiles were included in the pharmacokinetic (PK) analysis||101.87|97.32|
72595801|NCT02267135|144722990|SUPERIORITY_OR_OTHER_LEGACY||Difference between percentages|51.0|||<|0.001|TWO_SIDED|95.0|37.0|65.0|||Cochran-Mantel-Haenszel|adjusted for body weight (\< 90 kg, ≥ 90 kg)||||65|37|<0.001
72595802|NCT02892513|144723003|SUPERIORITY|||||||0.97|||||||t-test, 2 sided|||||||0.97
72595803|NCT01554176|144723030|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.7||||0.679|TWO_SIDED|95.0|-3.8|2.5||cLDA model included terms for treatment, time, the interaction of time by treatment, severity of disease (Hamilton Depression Rating Scale, 17-items \[HAM-D17\] ≤20, \>20) and insomnia severity index (ISI ≤14, \>14).|cLDA|||Number of participants included for calculation of mean ± SD baseline and mean ± SD change from baseline MADRS Total Score is 119. Constrained longitudinal data analysis (cLDA) model uses efficacy Full Analysis Set (FAS) population (number of participants: filorexant 10 mg - 64, placebo - 64; total number of participants in cLDA analysis - 128).||2.5|-3.8|0.679
72595804|NCT01554176|144723031|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.3||||0.82|TWO_SIDED|95.0|-3.2|2.5||cLDA model included terms for treatment, time, the interaction of time by treatment, severity of disease (Hamilton Depression Rating Scale, 17-items \[HAM-D17\] ≤20, \>20) and insomnia severity index (ISI ≤14, \>14).|cLDA|||Pairwise Comparison: Filorexant 10 mg vs. Placebo||2.5|-3.2|0.820
72595805|NCT01554176|144723032|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.3||||0.701|TWO_SIDED|95.0|-1.9|1.3||cLDA model included terms for treatment, time, the interaction of time by treatment, severity of disease (Hamilton Depression Rating Scale, 17-items \[HAM-D17\] ≤20, \>20) and insomnia severity index (ISI ≤14, \>14).|cLDA|||Pairwise Comparison: Filorexant 10 mg vs. Placebo||1.3|-1.9|0.701
72595806|NCT01554176|144723033|SUPERIORITY_OR_OTHER||Estimated Odds Ratio|2.5||||0.0965|TWO_SIDED|95.0|0.8|7.3||Generalized linear mixed effects model included terms for treatment, time, treatment-by-time interaction.|Generalized Linear Mixed Effects Model|||Pairwise Comparison: Filorexant 10 mg vs. Placebo||7.3|0.8|0.0965
72595807|NCT01554176|144723034|SUPERIORITY_OR_OTHER||Difference in percentage incidence|15.6|||||TWO_SIDED|95.0|-0.9|31.4||||Between-group comparison of AE incident rate||Estimated parameter is between-group difference in percentage of participants with an AE = percentage (filorexant 10 mg) - percentage (placebo) for participants with one or more AE.||31.4|-0.9|
72595808|NCT01554176|144723035|SUPERIORITY_OR_OTHER||Difference in percentage incidence|0.0|||||TWO_SIDED|95.0|-7.0|7.0||||Between-group comparison of incidence rate of drug discontinuation due to AE||Estimated parameter is between-group difference in percentage of participants discontinued from study drug due to an AE = percentage (filorexant 10 mg) - percentage (placebo).||7|-7|
72595809|NCT00460265|144723069|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.873||||0.1403||95.0|0.729|1.046|||Log Rank|Stratified by IVRS randomization factors (ECOG(0:1),previously treated w/ CT/RT(yes:no),primary tumor site(oropharynx/larynx:oral cavity/hypopharynx))|Hazard ratio from Cox proportional hazards model stratified by IVRS randomization factors; hazard ratio presented as panitumumab plus chemotherapy:chemotherapy alone.|||1.046|0.729|0.1403
72595810|NCT00460265|144723070|SUPERIORITY_OR_OTHER||Difference in percentages|10.98||||||95.0|3.13|18.68||||||||18.68|3.13|
72595811|NCT00460265|144723070|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.69||||||95.0|1.15|2.44||||||||2.44|1.15|
72595812|NCT00460265|144723074|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.78||||||95.0|0.659|0.922|||||Cox proportional hazards model stratified by IVRS randomization factors|||0.922|0.659|
72415265|NCT01968213|144341086|SUPERIORITY||Cox Proportional Hazard|0.365|||<|0.0001|TWO_SIDED|95.0|0.295|0.451|||Regression, Cox||||Analysis is performed by randomization strata of HRD classification by CTA, best response, and penultimate platinum progression-free interval.|0.451|0.295|<0.0001
72595813|NCT03114657|144723110|SUPERIORITY||Least Squares Mean Difference|1.3|STANDARD_ERROR_OF_MEAN|0.633|||TWO_SIDED|95.0|0.0|2.6||||||||2.60|0.00|
72595814|NCT03114657|144723111|SUPERIORITY||Least Squares Mean Difference|1.74|STANDARD_ERROR_OF_MEAN|2.028|||TWO_SIDED|95.0|-2.4|5.89||||||||5.89|-2.40|
72595815|NCT03114657|144723112|SUPERIORITY||Least Squares Mean Difference|0.33|STANDARD_ERROR_OF_MEAN|2.124|||TWO_SIDED|95.0|-4.03|4.68||||||||4.68|-4.03|
72595816|NCT03114657|144723113|SUPERIORITY||Least Squares Mean Difference|0.09|STANDARD_ERROR_OF_MEAN|0.141|||TWO_SIDED|95.0|-0.2|0.39||||||||0.39|-0.20|
72595817|NCT03114657|144723114|SUPERIORITY||Least Squares Mean Difference|-0.41|STANDARD_ERROR_OF_MEAN|0.985|||TWO_SIDED|95.0|-2.42|1.6||||||||1.60|-2.42|
72595818|NCT03114657|144723115|SUPERIORITY||Least Squares Mean Difference|-2.52|STANDARD_ERROR_OF_MEAN|3.052|||TWO_SIDED|95.0|-8.74|3.7||||||||3.70|-8.74|
72595819|NCT03114657|144723116|SUPERIORITY||Least Squares Mean Difference|-1.19|STANDARD_ERROR_OF_MEAN|2.501|||TWO_SIDED|95.0|-6.29|3.92||||||||3.92|-6.29|
72595820|NCT03114657|144723117|SUPERIORITY||Least Squares Mean Difference|0.63|STANDARD_ERROR_OF_MEAN|1.42|||TWO_SIDED|95.0|-2.25|3.51||||||||3.51|-2.25|
72595821|NCT03114657|144723119|SUPERIORITY||Least Squares Mean Difference|-0.76|STANDARD_ERROR_OF_MEAN|0.502|||TWO_SIDED|95.0|-1.75|0.23||||||||0.23|-1.75|
72595822|NCT03114657|144723120|SUPERIORITY||Least Squares Mean Difference|-0.46|STANDARD_ERROR_OF_MEAN|1.383|||TWO_SIDED|95.0|-3.3|2.39||||||||2.39|-3.30|
72595823|NCT03114657|144723121|SUPERIORITY||Least Squares Mean Difference|6.55|STANDARD_ERROR_OF_MEAN|5.527|||TWO_SIDED|95.0|-4.35|17.44||||||||17.44|-4.35|
72595824|NCT03114657|144723122|SUPERIORITY||Least Squares Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|5.831|||TWO_SIDED|95.0|-12.31|11.71||||||||11.71|-12.31|
72595825|NCT03114657|144723123|SUPERIORITY||Least Squares Mean Difference|-3.38|STANDARD_ERROR_OF_MEAN|3.94|||TWO_SIDED|95.0|-11.5|4.73||||||||4.73|-11.50|
72595826|NCT03114657|144723129|SUPERIORITY||Least Squares Mean Difference|-0.56|STANDARD_ERROR_OF_MEAN|0.622|||TWO_SIDED|95.0|-2.01|0.89||||||||0.89|-2.01|
72595827|NCT03114657|144723130|SUPERIORITY||Least Squares Mean Difference|1.6|STANDARD_ERROR_OF_MEAN|1.668|||TWO_SIDED|95.0|-1.7|4.9||||||||4.90|-1.70|
72595828|NCT03114657|144723131|SUPERIORITY||Least Squares Mean Difference|-0.36|STANDARD_ERROR_OF_MEAN|0.373|||TWO_SIDED|95.0|-1.13|0.41||||||||0.41|-1.13|
72595829|NCT01075399|144723132|SUPERIORITY_OR_OTHER||Pearson's Correlation Coefficient|0.883|||<|0.001|TWO_SIDED|90.0|0.802|0.929||Significance of probability for no association between the first and second pre-treatment uptake.|Pearson's correlation|||"Primary Tumor SUV max:~The reproducibility of \[F-18\]HX4 uptake in primary tumors was assessed by comparing SUV max of the 1st and 2nd \[F18\]HX4 PET/CT scan.~Estimated power for a range of coefficients of variation (CVs) postulated for the paired differences in SUV values, and for establishing reproducibility within ±20% or ±25%."||0.929|0.802|<0.001
72595830|NCT01075399|144723132|SUPERIORITY_OR_OTHER||Pearson's Correlation Coefficient|0.887|||<|0.001|TWO_SIDED|90.0|0.792|0.925||Significance of probability for no association between the first and second pre-treatment uptake.|Pearson's correlation|||"Primary Tumor SUV mean:~The reproducibility of \[F-18\]HX4 uptake in primary tumors was assessed by comparing SUV mean of the 1st and 2nd \[F18\]HX4 PET/CT scan.~Estimated power for a range of coefficients of variation (CVs) postulated for the paired differences in SUV values, and for establishing reproducibility within ±20% or ±25%."||0.925|0.792|<0.001
72595831|NCT01075399|144723132|SUPERIORITY_OR_OTHER||Pearson's Correlation Coefficient|0.945|||<|0.001|TWO_SIDED|90.0|0.904|0.967||Significance of probability for no association between the first and second pre-treatment uptake.|Pearson's correlation|||"Primary Tumor to background SUV ratio:~The reproducibility of \[F-18\]HX4 uptake in primary tumors was assessed by comparing tumor to background SUV ratio (T/B) of the 1st and 2nd \[F18\]HX4 PET/CT scan.~Estimated power for a range of coefficients of variation (CVs) postulated for the paired differences in T/B values, and for establishing reproducibility within ±20% or ±25%."||0.967|0.904|<0.001
72595832|NCT01546038|144723138|OTHER||Hazard Ratio (HR)|0.569||||0.002|TWO_SIDED|80.0|0.441|0.734||1-sided p-value from the log-rank test stratified by prognosis stratum according to Interactive Voice Response System (IVRS).|Log Rank||Based on the Cox proportional hazards model stratified by prognosis stratum according to IVRS.|||0.734|0.441|0.0020
72595833|NCT01546038|144723142|OTHER||Odds Ratio (OR)|4.2755||||0.0112|TWO_SIDED|80.0|1.3057|13.9994|||Cochran-Mantel-Haenszel||Based on the Cox proportional hazards model stratified by prognosis stratum according to IVRS.|||13.9994|1.3057|0.0112
72595834|NCT04245202|144723206|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
72595835|NCT04245202|144723207|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
72595836|NCT04245202|144723208|OTHER|||||||0.003|||||||Wilcoxon (Mann-Whitney)|||||||0.003
72595837|NCT04245202|144723209|OTHER||Mean Difference (Net)|-12.29|STANDARD_DEVIATION|5.72|<|0.001|TWO_SIDED|95.0|-23.53|-1.05||The p-Value of the interaction between time and groups was given. In all analyses, p values \<0·05 were considered being statistically significant.|Mixed Models Analysis||Treatment difference= High-Flow Nasal Cannula Oxygen Therapy (96-0 h) - Standard Face Mask Oxygen Therapy (96-0 h) (based on least-square means)|||-1.05|-23.53|<0.001
72595838|NCT04245202|144723210|OTHER||Mean Difference (Net)|-12.66|STANDARD_DEVIATION|4.77|<|0.001|TWO_SIDED|95.0|-22.05|-3.28|||Mixed Models Analysis||Treatment difference= High-Flow Nasal Cannula Oxygen Therapy (96-0 h) - Standard Face Mask Oxygen Therapy (96-0 h) (based on least-square means)|The p-Value of the interaction between time and groups was given. In all analyses, p values \<0·05 were considered being statistically significant.||-3.28|-22.05|<0.001
72595839|NCT04245202|144723211|OTHER||Mean Difference (Net)|-3.91|STANDARD_DEVIATION|2.43|<|0.001|TWO_SIDED|95.0|-8.68|0.86||The p-Value of the interaction between time and groups was given. In all analysis, p values \<0.05 were considered being statistically significant.|Mixed Models Analysis||Treatment difference= High-Flow Nasal Cannula Oxygen Therapy (96-0 h) - Standard Face Mask Oxygen Therapy (96-0 h) (based on least-square means)|||0.86|-8.68|<0.001
72595840|NCT04245202|144723212|OTHER||Mean Difference (Net)|-2.41|STANDARD_DEVIATION|2.14||0.003|TWO_SIDED|95.0|-6.62|1.78|||Mixed Models Analysis||Treatment difference= High-Flow Nasal Cannula Oxygen Therapy (96-0 h) - Standard Face Mask Oxygen Therapy (96-0 h) (based on least-square means)|The p-Value of the interaction between time and groups was given. In all analysis, p values \<0.05 were considered being statistically significant.||1.78|-6.62|0.003
72595841|NCT04245202|144723213|OTHER||Relative treatment effect difference|-0.07||||0.002|TWO_SIDED|||||The p-Value of the interaction between time and groups was given. In all analysis, p values \<0.05 were considered being statistically significant.|Brunner-Langer Method||Relative Treatment Effect Difference= High-Flow Nasal Cannula Oxygen Therapy (96-0 h) - Standard Face Mask Oxygen Therapy (96-0 h) (based on least-square means)|||||0.002
72595842|NCT04245202|144723214|OTHER||Relative treatment effect difference|-0.08||||0.001|TWO_SIDED|95.0||||The p-Value of the interaction between time and groups was given. In all analysis, p values \<0.05 were considered being statistically significant.|Brunner-Langer Method||Relative Treatment Effect Difference= High-Flow Nasal Cannula Oxygen Therapy (96-0 h) - Standard Face Mask Oxygen Therapy (96-0 h) (based on least-square means)|||||0.001
72595843|NCT04245202|144723216|OTHER|||||||0.08|||||||Wilcoxon (Mann-Whitney)|||||||0.08
72595844|NCT04245202|144723217|OTHER|||||||0.22|||||||Wilcoxon (Mann-Whitney)|||||||0.22
72595845|NCT04245202|144723218|OTHER|||||||0.99|||||||Wilcoxon (Mann-Whitney)|||||||0.99
72595846|NCT04245202|144723219|OTHER|||||||0.02|||||||Fisher Exact|||||||0.02
72595847|NCT04245202|144723220|OTHER|||||||0.02|||||||Fisher Exact|||||||0.02
72595848|NCT04245202|144723221|OTHER|||||||0.08|||||||Fisher Exact|||||||0.08
72595849|NCT00987402|144723251|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||generalized estimating equation|||Power calculations assumed a 2-sided alpha error of 0.05 and a power of 80%. We performed power calculations using a statistical model for a cluster-randomized trial with 8, 10 or 12 clusters including 6 operating rooms each, with different levels of reduction (10%, 30%, 50%) in surgical site infection rates in the active intervention period. By reaching a sample size of 3133 patients, the study was powered to detect a 30% reduction effect in SSI rates, from 10% to 7%.||||<0.05
72595850|NCT01430624|144723252|SUPERIORITY_OR_OTHER|||||||0.24|TWO_SIDED|||||6 month follow-up comparison|ANOVA|df 2, 109||||||.24
72595851|NCT01430624|144723253|SUPERIORITY_OR_OTHER|||||||0.89|TWO_SIDED|||||6 month follow-up comparison|ANOVA|df = 2, 111||||||.89
72595852|NCT01430624|144723254|SUPERIORITY_OR_OTHER|||||||0.01|TWO_SIDED|||||6 week comparison|ANOVA|df = 2, 150||||||.01
72595853|NCT01430624|144723254|SUPERIORITY_OR_OTHER|||||||0.48|TWO_SIDED|||||3 month comparison|ANOVA|||||||.48
72595854|NCT01430624|144723254|SUPERIORITY_OR_OTHER|||||||0.17|TWO_SIDED|||||6 month comparison|ANOVA|||||||.17
72595855|NCT01430624|144723255|SUPERIORITY_OR_OTHER|||||||0.37|TWO_SIDED|||||6 week comparison|Chi-squared|df = 2, 154||||||.37
72595856|NCT01430624|144723255|SUPERIORITY_OR_OTHER|||||||0.15|TWO_SIDED|||||3 month comparison|Chi-squared|df = 2, 135||||||.15
72595857|NCT01430624|144723255|SUPERIORITY_OR_OTHER|||||||0.87|TWO_SIDED|||||6 month comparison|Chi-squared|df = 2, 121||||||.87
72595858|NCT01430624|144723256|SUPERIORITY_OR_OTHER|||||||0.63|TWO_SIDED|||||6 week comparison|ANOVA|df = 2, 150||||||.63
72595859|NCT01430624|144723256|SUPERIORITY_OR_OTHER|||||||0.25|TWO_SIDED|||||3 month comparison|ANOVA|df = 2, 132||||||.25
72595860|NCT01430624|144723256|SUPERIORITY_OR_OTHER|||||||0.59|TWO_SIDED|||||6 month comparison|ANOVA|df = 2, 118||||||.59
72595861|NCT01430624|144723257|SUPERIORITY_OR_OTHER|||||||0.83|TWO_SIDED|||||6 week comparison|ANOVA|df = 2, 151||||||.83
72595862|NCT01430624|144723257|SUPERIORITY_OR_OTHER|||||||0.29|TWO_SIDED|||||3 month comparison|ANOVA|df = 2, 132||||||.29
72595863|NCT01430624|144723257|SUPERIORITY_OR_OTHER|||||||0.13|TWO_SIDED|||||6 month comparison|ANOVA|df = 2, 118||||||.13
72595864|NCT01430624|144723258|SUPERIORITY_OR_OTHER|||||||0.012|TWO_SIDED|||||6 week comparison|ANOVA|df = 2, 151||||||.012
72595865|NCT01430624|144723258|SUPERIORITY_OR_OTHER|||||||0.31|TWO_SIDED|||||3 month comparison|ANOVA|df = 2, 132||||||.31
72595866|NCT01430624|144723258|SUPERIORITY_OR_OTHER|||||||0.35|TWO_SIDED|||||6 month comparison|ANOVA|df = 2,116||||||.35
72595867|NCT01430624|144723259|SUPERIORITY_OR_OTHER|||||||0.15|TWO_SIDED|||||6 week comparison|ANOVA|df = 2, 141||||||.15
72595868|NCT01430624|144723259|SUPERIORITY_OR_OTHER|||||||0.67|TWO_SIDED|||||3 month comparison|ANOVA|df = 2, 127||||||.67
72595869|NCT01430624|144723259|SUPERIORITY_OR_OTHER|||||||0.4|TWO_SIDED|||||6 month comparison|ANOVA|df = 2, 110||||||.40
72595870|NCT03878875|144723269|SUPERIORITY|Multiple linear regressions analysed the effect of conditioning (group) on each outcome at the second time point - session 2 (after noise exposure), controlling for session 1 outcome (before noise exposure), event exposure, age, and gender. It was hypothesised those with high recent noise exposure, Group 1 (noise unit \> 0.323), would experience less temporary hearing damage than irregular attendees, Group 0.|F(5, 26)|116.044|||<|0.0005|TWO_SIDED||||||Regression, Linear|Group coefficient = -2.153.||||||< 0.0005
72595871|NCT03878875|144723270|SUPERIORITY|Multiple linear regressions analysed the effect of conditioning (group) on each outcome at the second time point - session 2 (after noise exposure), controlling for session 1 outcome (before noise exposure), event exposure, age, and gender. It was hypothesised those with high recent noise exposure, Group 1 (noise unit \> 0.323), would experience less temporary hearing damage than irregular attendees, Group 0.|F(5, 26)|12.839|||<|0.0005|TWO_SIDED||||||Regression, Linear|Group coefficient = 1.602.||||||< 0.0005
72595872|NCT03878875|144723271|SUPERIORITY|Multiple linear regressions analysed the effect of conditioning (group) on each outcome at the second time point - session 2 (after noise exposure), controlling for session 1 outcome (before noise exposure), event exposure, age, and gender. It was hypothesised those with high recent noise exposure, Group 1 (noise unit \> 0.323), would experience less temporary hearing damage than irregular attendees, Group 0.|F(5, 26)|8.391|||<|0.0005|TWO_SIDED||||||Regression, Linear|Group coefficient was 1.059.||||||< 0.0005
72595873|NCT03878875|144723272|SUPERIORITY|Multiple linear regressions analysed the effect of conditioning (group) on each outcome at the second time point - session 2 (after noise exposure), controlling for session 1 outcome (before noise exposure), event exposure, age, and gender. It was hypothesised those with high recent noise exposure, Group 1 (noise unit \> 0.323), would experience less temporary hearing damage than irregular attendees, Group 0.|F(5, 26)|6.416|||<|0.001|TWO_SIDED||||||Regression, Linear|Group coefficient was 0.635.||||||< 0.001
72595874|NCT03878875|144723273|SUPERIORITY|Multiple linear regressions analysed the effect of conditioning (group) on each outcome at the second time point - session 2 (after noise exposure), controlling for session 1 outcome (before noise exposure), event exposure, age, and gender. It was hypothesised those with high recent noise exposure, Group 1 (noise unit \> 0.323), would experience less temporary hearing damage than irregular attendees, Group 0.|F(5, 26)|5.805|||<|0.001|TWO_SIDED||||||Regression, Linear|Group coefficient was -0.383.||||||< 0.001
72415266|NCT01968213|144341087|SUPERIORITY||Cox Proportional Hazard|0.354|||<|0.0001|TWO_SIDED|95.0|0.278|0.45|||Regression, Cox||||Analysis is performed by randomization strata of HRD classification by CTA, best response, and penultimate platinum progression-free interval.|0.450|0.278|<0.0001
72415267|NCT02081846|144341109|SUPERIORITY|||||||0.047|||||||Regression, Logistic|||||||0.047
72415268|NCT02081846|144341110|SUPERIORITY|||||||0.32|||||||Regression, Linear|||||||0.32
72415269|NCT02081846|144341111|SUPERIORITY|||||||0.82|||||||censored Poisson model|||||||0.82
72415270|NCT02081846|144341112|SUPERIORITY||||||<|0.01|||||||Poisson model|||||||<0.01
72415271|NCT02081846|144341113|SUPERIORITY|||||||0.08|||||||Regression, Logistic|||||||0.08
72415272|NCT02081846|144341114|SUPERIORITY|||||||0.052|||||||Regression, Logistic|||||||0.052
72595875|NCT03878875|144723274|SUPERIORITY|A binary logistic regression was employed to assess the effect of conditioning on tinnitus change (i.e. increasing or not) at session 2, adjusting for tinnitus reported at session 1, age, gender, and event exposure.|Odds Ratio (OR)|1.4|STANDARD_ERROR_OF_MEAN|0.14|<|0.005|TWO_SIDED|95.0|1.071|1.85|||Regression, Logistic|||||1.85|1.071|< 0.005
72595876|NCT00236899|144723277|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.14||||0.345||95.0|0.87|1.5|||Regression, Cox|||||1.50|0.87|0.345
72595877|NCT00236899|144723278|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.98||||0.885|TWO_SIDED|95.0|0.69|1.37|||Regression, Cox|||||1.37|0.69|0.885
72595878|NCT00236899|144723279|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.01||||0.976|TWO_SIDED|95.0|0.71|1.42|||Regression, Cox|||||1.42|0.71|0.976
72595879|NCT00236899|144723280|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.442||||0.0028|TWO_SIDED|95.0|0.259|0.754|||Regression, Logistic|||||0.754|0.259|0.0028
72595880|NCT00236899|144723281|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.23||||0.15|TWO_SIDED|95.0|0.93|1.62|||Regression, Cox|||||1.62|0.93|0.150
72415273|NCT02081846|144341115|SUPERIORITY|||||||0.12|||||||Regression, Logistic|||||||0.12
72595881|NCT00236899|144723282|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.818||||0.4567|TWO_SIDED|95.0|0.482|1.389|||Regression, Logistic|||||1.389|0.482|0.4567
72595882|NCT00236899|144723284|SUPERIORITY_OR_OTHER|||||||0.142||95.0||||This is the p-value for Treatment Schedule (Docetaxel and Gemcitabine 3 Weekly + Paclitaxel and Gemcitabine 3 Weekly) and Treatment Drug (Docetaxel and Gemcitabine Weekly + Paclitaxel and Gemcitabine Weekly).|Fisher Exact|||||||0.142
72415274|NCT02251990|144341133|SUPERIORITY_OR_OTHER||||||<|0.001||||||The p-value was based on a one-sided asymptotic test for a binomial proportion. A one-sided p-value \<0.0125 was considered supportive of a conclusion that the true SVR12 is \>73%.|one-sided asymptotic test|||A one-sided Wald test was used to test the null hypothesis, which was that the SVR12 rate for the ITG was ≤ the historical reference rate of 73%. The historical reference SVR rate for treatment-naive genotype 1 predominantly Asian participants treated with pegylated interferon/ribavirin was derived from 2 studies (PMCID: PMC417, PMCID: PMC3644280) after adjusting for an expected improved safety profile related to an interferon-free regimen.||||<0.001
72415275|NCT02251990|144341134|SUPERIORITY_OR_OTHER||Difference in Percentages|-0.5|||||TWO_SIDED|95.0|-10.6|9.6||||||Estimates and 95% CIs were calculated for between-treatment differences (ITG minus DTG) in the percentage of participants with events using the Miettinen and Nurminen method.||9.6|-10.6|
72415276|NCT02251990|144341135|SUPERIORITY_OR_OTHER||Difference in Percentages|-0.5|||||TWO_SIDED|95.0|-4.2|0.9||||||Estimates and 95% CIs were calculated for between-treatment differences (ITG minus DTG) in the percentage of participants with events using the Miettinen and Nurminen method.||0.9|-4.2|
72415277|NCT02558010|144341138|SUPERIORITY||||||<|0.05||||||The p-value was calculated, and does not indicate the threshold for statistical significance.|Mixed Models Analysis|||||||<0.05
72415278|NCT00295750|144341140|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority limit was -10 percentage points.|Difference in cumulative probability|1.9||||||97.5|-1.8|5.7||||||A non-inferiority assessment determined whether degarelix was non-inferior to leuprolide with respect to the cumulative probability of testosterone \<=0.5 ng/mL from Day 28 to Day 364.||5.7|-1.8|
72415279|NCT00295750|144341140|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority limit was -10 percentage points.|Difference in cumulative probability|0.9||||||97.5|-3.2|5.0||||||A non-inferiority assessment determined whether degarelix was non-inferior to leuprolide with respect to the cumulative probability of testosterone \<=0.5 ng/mL from Day 28 to Day 364.||5.0|-3.2|
72415280|NCT00295750|144341141|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Fisher Exact|||||||<0.0001
72415281|NCT00295750|144341141|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Fisher Exact|||||||<0.0001
72415282|NCT00295750|144341142|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Fisher Exact|||||||<0.0001
72415283|NCT00295750|144341142|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Fisher Exact|||||||<0.0001
72415284|NCT00295750|144341144|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon (Mann-Whitney)|||Percentage change from baseline to Day 14||||<0.0001
72415285|NCT00295750|144341144|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon (Mann-Whitney)|||Percentage change from baseline to Day 14||||<0.0001
72415286|NCT00295750|144341144|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon (Mann-Whitney)|||Percentage change from baseline to Day 28||||<0.0001
72415287|NCT00295750|144341144|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon (Mann-Whitney)|||Percentage change from baseline to Day 28||||<0.0001
72415288|NCT00295750|144341145|SUPERIORITY_OR_OTHER||Cumulative probability|85.8||||||95.0|79.8|90.1|||||95% confidence interval for the cumulative probability of completing the study without prostate specific antigen failure from Day 0 to Day 364.|||90.1|79.8|
72415289|NCT00295750|144341145|SUPERIORITY_OR_OTHER||Cumulative probability|91.1||||||95.0|85.9|94.5|||||95% confidence interval for the cumulative probability of completing the study without prostate specific antigen failure from Day 0 to Day 364.|||94.5|85.9|
72595883|NCT00236899|144723284|SUPERIORITY_OR_OTHER|||||||0.47||95.0||||This is the p-value for Treatment Drug (Docetaxel and Gemcitabine 3 Weekly + Docetaxel and Gemcitabine Weekly vs Paclitaxel and Gemcitabine 3 Weekly + Paclitaxel and Gemcitabine Weekly).|Fisher Exact|||||||0.470
72595884|NCT00236899|144723285|SUPERIORITY_OR_OTHER|||||||0.293||95.0||||This is the p-value for Treatment Schedule (Docetaxel and Gemcitabine 3 Weekly + Paclitaxel and Gemcitabine 3 Weekly) and Treatment Drug (Docetaxel and Gemcitabine Weekly + Paclitaxel and Gemcitabine Weekly).|Fisher Exact|||||||0.293
72595885|NCT00236899|144723285|SUPERIORITY_OR_OTHER|||||||0.476||95.0||||This is the p-value for Treatment Drug (Docetaxel and Gemcitabine 3 Weekly + Docetaxel and Gemcitabine Weekly vs Paclitaxel and Gemcitabine 3 Weekly + Paclitaxel and Gemcitabine Weekly).|Fisher Exact|||||||0.476
72595886|NCT03379792|144723288|OTHER|||||||0.24|||||||t-test, 2 sided|||||||0.24
72595887|NCT03379792|144723288|OTHER|||||||0.22|||||||t-test, 2 sided|||||||0.22
72595888|NCT03379792|144723288|OTHER|||||||1|||||||t-test, 2 sided|||||||1.0
72595889|NCT03924505|144723305|SUPERIORITY||Incidence Rate Ratio|2.15|||<|0.01|TWO_SIDED|95.0|1.42|2.35||A priori threshold for statistical significance set at p\<0.05|Negative Binomial Regression|We adjusted for baseline rate due to baseline differences.|The incidence rate ratio estimates the effect of facilitation for implementation effectiveness and dissemination of best practice recommendations, as compared to dissemination of best practice recommendations.|||2.35|1.42|<0.01
72595890|NCT03924505|144723306|SUPERIORITY||Incidence Rate Ratio|1.97||||0.01|TWO_SIDED|95.0|1.18|3.3||A priori threshold for statistical signicance is p\<0.05|Negative Binomial Regression||The incidence rate ratio estimates the effect of facilitation for implementation effectiveness and dissemination of best practice recommendations, as compared to dissemination of best practice recommendations.|||3.30|1.18|0.01
72595891|NCT03924505|144723307|OTHER|Testing for differences in means|Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|0.4||0.68|TWO_SIDED|95.0|-0.7|1.0|||t-test, 2 sided|||||1.0|-0.7|0.68
72595892|NCT00568334|144723313|NON_INFERIORITY|The lower limit (LL) of the 95% confidence interval (CI) for the GMT ratio (derived from IFA) between Group Varilrix HSA-Free and (divided by) Group Varilrix is equal to or above (≥) the pre-defined clinical limit of 0.5.|GMT Ratio|1.12|||||TWO_SIDED|95.0|0.86|1.46|||ANOVA|||Non-inferiority of Varilrix™ HSA-Free vaccine as compared to Varilrix™ vaccine in terms of geometric mean titers (GMTs) of varicella zoster virus (VZV) antibodies 43-57 days after the first vaccine dose.||1.46|0.86|
72595893|NCT00568334|144723314|NON_INFERIORITY|The lower limit (LL) of the 95% confidence interval (CI) for the GMC ratio (derived from ELISA) between Group Varilrix HSA-Free and (divided by) Group Varilrix is equal to or above (≥) the pre-defined clinical limit of 0.67.|GMC Ratio|1.12|||||TWO_SIDED|95.0|0.93|1.33|||ANOVA|||Non-inferiority of Varilrix™ HSA-Free vaccine as compared to Varilrix™ vaccine in terms of geometric mean concentrations (GMCs) of varicella zoster virus (VZV) antibodies 43-57 days after the first vaccine dose.||1.33|0.93|
72595894|NCT00306787|144723335|NON_INFERIORITY_OR_EQUIVALENCE|The estimated power for non-inferiority test (90%) was based on the non-inferiority margin of 1.0 day.|Median Difference (Final Values)|0.16|||||TWO_SIDED|95.0|-0.15|0.6|||Hodges-Lehman|||Difference in time to healing= time to healing for famciclovir- time to healing for valacyclovir.||0.60|-0.15|
72595895|NCT02273908|144723341|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.949|||<|0.001|TWO_SIDED|95.0|-1.459|-0.439|||Mixed Models Analysis|||||-0.439|-1.459|<0.001
72595896|NCT02273908|144723342|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-2.259|||<|0.001|TWO_SIDED|95.0|-3.131|-1.387|||Mixed Models Analysis|||Analysis on the mean difference between two groups with the change from baseline at Week 8.||-1.387|-3.131|<0.001
72595897|NCT02273908|144723342|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.887|||<|0.001|TWO_SIDED|95.0|-2.704|-1.071|||Mixed Models Analysis|||Analysis on the mean difference between two groups with the change from baseline at Week 4.||-1.071|-2.704|<0.001
72595898|NCT02273908|144723343|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.3018|||<|0.001|TWO_SIDED|95.0|1.4903|5.1133|||Mixed Models Analysis|||Analysis on the mean difference between two groups with the change from baseline at Week 8.||5.1133|1.4903|<0.001
72595899|NCT02273908|144723343|SUPERIORITY_OR_OTHER_LEGACY||Least square mean difference|2.729||||0.004|TWO_SIDED|95.0|0.9047|4.5533|||Mixed Models Analysis|||Analysis on the mean difference between two groups with the change from baseline at Week 4.||4.5533|0.9047|0.004
72595900|NCT02273908|144723344|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.83|||<|0.001|TWO_SIDED|95.0|-1.301|-0.359|||Mixed Models Analysis|||Analysis on the mean difference between two groups with the change from baseline at Week 8.||-0.359|-1.301|<0.001
72595901|NCT02273908|144723344|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.674||||0.004|TWO_SIDED|95.0|-1.125|-0.223|||Mixed Models Analysis|||Analysis on the mean difference between two groups with the change from baseline at Week 4.||-0.223|-1.125|0.004
72595902|NCT02273908|144723345|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0204||||0.175|TWO_SIDED|95.0|-0.0091|0.0499|||Mixed Models Analysis|||Analysis on the mean difference between two groups with the change from baseline at Week 8.||0.0499|-0.0091|0.175
72595903|NCT02273908|144723345|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0329||||0.017|TWO_SIDED|95.0|0.0058|0.06|||Mixed Models Analysis|||Analysis on the mean difference between two groups with the change from baseline at Week 4.||0.0600|0.0058|0.017
72595904|NCT02273908|144723346|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.697||||0.026|TWO_SIDED|95.0|0.552|8.842|||Mixed Models Analysis|||Analysis on the mean difference between two groups with the change from baseline at Week 8.||8.842|0.552|0.026
72595905|NCT02273908|144723346|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.292||||0.477|TWO_SIDED|95.0|-2.282|4.866|||Mixed Models Analysis|||Analysis on the mean difference between two groups with the change from baseline at Week 4.||4.866|-2.282|0.477
72595906|NCT02273908|144723347|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Modified Chi-squared|||||||<0.001
72595907|NCT02273908|144723348|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Modified Chi-squared|||||||<0.001
72595908|NCT04908475|144723351|SUPERIORITY||Adjusted Difference|50.7|||<|0.001|TWO_SIDED|95.0|41.3|60.1||Adjusted for strata (baseline body weight \[≤ 100 kg, \> 100 kg\] and prior exposure to any systemic and/or biologic treatment for psoriasis \[0, ≥ 1\]) for the comparison of 2 treatment groups.|Cochran-Mantel-Haenszel|||||60.1|41.3|< 0.001
72595909|NCT04908475|144723352|SUPERIORITY||Adjusted Difference|56.8|||<|0.001|TWO_SIDED|95.0|47.7|66.0||Adjusted for strata (baseline body weight \[≤ 100 kg, \> 100 kg\] and prior exposure to any systemic and/or biologic treatment for psoriasis \[0, ≥ 1\]) for the comparison of 2 treatment groups.|Cochran-Mantel-Haenszel|||||66.0|47.7|< 0.001
72595910|NCT04908475|144723353|SUPERIORITY||Difference|69.7|||<|0.001|TWO_SIDED|95.0|59.5|80.0|||Chi-squared|||||80.0|59.5|< 0.001
72595911|NCT04908475|144723354|SUPERIORITY||Adjusted Difference|65.9|||<|0.001|TWO_SIDED|95.0|57.6|73.9||Adjusted for strata (baseline body weight \[≤ 100 kg, \> 100 kg\] and prior exposure to any systemic and/or biologic treatment for psoriasis \[0, ≥ 1\] for the comparison of 2 treatment groups.|Cochran-Mantel-Haenszel|||||73.9|57.6|< 0.001
72595912|NCT04908475|144723355|SUPERIORITY||Difference|71.6|||<|0.001|TWO_SIDED|95.0|60.9|82.3|||Chi-squared|||||82.3|60.9|< 0.001
72595913|NCT04908475|144723356|SUPERIORITY||Difference|69.4|||<|0.001|TWO_SIDED|95.0|58.6|80.2|||Chi-squared|||||80.2|58.6|< 0.001
72595914|NCT01593254|144723378|SUPERIORITY|||||||0.005|||||||Cochran-Mantel-Haenszel|||||||0.005
72595915|NCT00076999|144723383|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||Fisher Exact|||Comparison of TPV OS 2-\<6 yrs versus TPV OS 6-\<12 yrs||||0.02
72595916|NCT00076999|144723383|SUPERIORITY_OR_OTHER|||||||0.78||95.0|||||Fisher Exact|||Comparison of TPV OS 12-18 yrs versus TPV SEDDS 12-18 yrs||||0.78
72595917|NCT00076999|144723384|SUPERIORITY_OR_OTHER|||||||0||95.0|||||Fisher Exact|||Comparison of TPV OS 2-\<6 yrs versus TPV OS 6-\<12 yrs||||0.00
72595918|NCT00076999|144723384|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|||Comparison of TPV OS 12-18 yrs versus TPV SEDDS 12-18 yrs||||1.00
72595919|NCT00076999|144723385|SUPERIORITY_OR_OTHER|||||||0.12||95.0|||||Fisher Exact|||Comparison of TPV OS 2-\<6 yrs versus TPV OS 6-\<12 yrs||||0.12
72595920|NCT00076999|144723385|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|||Comparison of TPV OS 12-18 yrs versus TPV SEDDS 12-18 yrs||||1.00
72595921|NCT00076999|144723386|SUPERIORITY_OR_OTHER|||||||0.12||95.0|||||Fisher Exact|||Comparison of TPV OS 2-\<6 yrs versus TPV OS 6-\<12 yrs||||0.12
72595922|NCT00076999|144723386|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|||Comparison of TPV OS 12-18 yrs versus TPV SEDDS 12-18 yrs||||1.00
72595923|NCT00076999|144723387|SUPERIORITY_OR_OTHER|||||||0.01||95.0|||||Fisher Exact|||Comparison of TPV OS 2-\<6 yrs versus TPV OS 6-\<12 yrs||||0.01
72595924|NCT00076999|144723387|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|||Comparison of TPV OS 12-18 yrs versus TPV SEDDS 12-18 yrs||||1.00
72595925|NCT00076999|144723388|SUPERIORITY_OR_OTHER|||||||0.06||95.0|||||Fisher Exact|||Comparison of TPV OS 2-\<6 yrs versus TPV OS 6-\<12 yrs||||0.06
72595926|NCT00076999|144723388|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|||Comparison of TPV OS 12-18 yrs versus TPV SEDDS 12-18 yrs||||1.00
72595927|NCT00076999|144723389|SUPERIORITY_OR_OTHER|||||||0.6||95.0|||||Fisher Exact|||Comparison of TPV OS 2-\<6 yrs versus TPV OS 6-\<12 yrs||||0.60
72595928|NCT00076999|144723389|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|||Comparison of TPV OS 12-18 yrs versus TPV SEDDS 12-18 yrs||||1.00
72595929|NCT00076999|144723390|SUPERIORITY_OR_OTHER|||||||0.2||95.0|||||Fisher Exact|||Comparison of TPV OS 2-\<6 yrs versus TPV OS 6-\<12 yrs||||0.20
72595930|NCT00076999|144723390|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|||Comparison of TPV OS 12-18 yrs versus TPV SEDDS 12-18 yrs||||1.00
72595931|NCT00076999|144723391|SUPERIORITY_OR_OTHER|||||||0.18||95.0|||||Fisher Exact|||Comparison of TPV OS 2-\<6 yrs versus TPV OS 6-\<12 yrs||||0.18
72595932|NCT00076999|144723391|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|||Comparison of TPV OS 12-18 yrs versus TPV SEDDS 12-18 yrs||||1.00
72595933|NCT00076999|144723393|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||ANOVA|||Comparison of TPV OS 2-\<6 yrs versus TPV OS 6-\<12 yrs||||0.02
72595934|NCT00076999|144723393|SUPERIORITY_OR_OTHER|||||||0.47||95.0|||||ANOVA|||Comparison of TPV OS 12-18 yrs versus TPV SEDDS 12-18 yrs||||0.47
72595935|NCT00076999|144723394|SUPERIORITY_OR_OTHER|||||||0||95.0|||||ANOVA|||Comparison of TPV OS 2-\<6 yrs versus TPV OS 6-\<12 yrs||||0.00
72595936|NCT00076999|144723394|SUPERIORITY_OR_OTHER|||||||0.81||95.0|||||ANOVA|||Comparison of TPV OS 12-18 yrs versus TPV SEDDS 12-18 yrs||||0.81
72595937|NCT00076999|144723395|SUPERIORITY_OR_OTHER|||||||0||95.0|||||ANOVA|||Comparison of TPV OS 2-\<6 yrs versus TPV OS 6-\<12 yrs||||0.00
72595938|NCT00076999|144723395|SUPERIORITY_OR_OTHER|||||||0.69||95.0|||||ANOVA|||Comparison of TPV OS 12-18 yrs versus TPV SEDDS 12-18 yrs||||0.69
72595939|NCT00076999|144723397|SUPERIORITY_OR_OTHER|||||||0.64||95.0|||||ANOVA|||Comparison of TPV OS 2-\<6 yrs versus TPV OS 6-\<12 yrs||||0.64
72595940|NCT00076999|144723397|SUPERIORITY_OR_OTHER|||||||0.26||95.0|||||ANOVA|||Comparison of TPV OS 12-18 yrs versus TPV SEDDS 12-18 yrs||||0.26
72595941|NCT00076999|144723398|SUPERIORITY_OR_OTHER|||||||0.25||95.0|||||ANOVA|||Comparison of TPV OS 2-\<6 yrs versus TPV OS 6-\<12 yrs||||0.25
72595942|NCT00076999|144723398|SUPERIORITY_OR_OTHER|||||||0.7||95.0|||||ANOVA|||Comparison of TPV OS 12-18 yrs versus TPV SEDDS 12-18 yrs||||0.70
72595943|NCT00076999|144723399|SUPERIORITY_OR_OTHER|||||||0.73||95.0|||||ANOVA|||Comparison of TPV OS 2-\<6 yrs versus TPV OS 6-\<12 yrs||||0.73
72595944|NCT00076999|144723399|SUPERIORITY_OR_OTHER|||||||0.79||95.0|||||ANOVA|||Comparison of TPV OS 12-18 yrs versus TPV SEDDS 12-18 yrs||||0.79
72595945|NCT00076999|144723401|SUPERIORITY_OR_OTHER|||||||0.38||95.0|||||ANOVA|||Comparison of TPV OS 2-\<6 yrs versus TPV OS 6-\<12 yrs||||0.38
72595946|NCT00076999|144723401|SUPERIORITY_OR_OTHER|||||||0.2||95.0|||||ANOVA|||Comparison of TPV OS 12-18 yrs versus TPV SEDDS 12-18 yrs||||0.20
72595947|NCT00076999|144723402|SUPERIORITY_OR_OTHER|||||||0.08||95.0|||||ANOVA|||Comparison of TPV OS 2-\<6 yrs versus TPV OS 6-\<12 yrs||||0.08
72595948|NCT00076999|144723402|SUPERIORITY_OR_OTHER|||||||0.36||95.0|||||ANOVA|||Comparison of TPV OS 12-18 yrs versus TPV SEDDS 12-18 yrs||||0.36
72595949|NCT00076999|144723403|SUPERIORITY_OR_OTHER|||||||0.23||95.0|||||ANOVA|||Comparison of TPV OS 2-\<6 yrs versus TPV OS 6-\<12 yrs||||0.23
72595950|NCT00076999|144723403|SUPERIORITY_OR_OTHER|||||||0.23||95.0|||||ANOVA|||Comparison of TPV OS 12-18 yrs versus TPV SEDDS 12-18 yrs||||0.23
72595951|NCT04964986|144723411|SUPERIORITY|||||||0.041|||||||paired t-test|||||||0.041
72595952|NCT04964986|144723413|SUPERIORITY||||||<|0.001|||||||paired t-test|||Week 24||||<0.001
72595953|NCT04964986|144723413|SUPERIORITY||||||<|0.001|||||||paired t-test|||Week 52||||<0.001
72595954|NCT04964986|144723417|SUPERIORITY|||||||0.002|||||||paired t-test|||Week 24||||0.002
72595955|NCT04964986|144723417|SUPERIORITY||||||<|0.001|||||||paired t-test|||Week 52||||<0.001
72595956|NCT04964986|144723419|SUPERIORITY|||||||0.294|||||||paired t-test|||Fat absorption increase at Week 4||||0.294
72595957|NCT04964986|144723419|SUPERIORITY|||||||0.155|||||||paired t-test|||Fat absorption increase at Week 48||||0.155
72595958|NCT04964986|144723419|SUPERIORITY|||||||0.26|||||||paired t-test|||Carbohydrate absorption at Week 4||||0.260
72595959|NCT04964986|144723419|SUPERIORITY|||||||0.024|||||||paired t-test|||Carbohydrate absorption at Week 48||||0.024
72595960|NCT04964986|144723419|SUPERIORITY|||||||0.096|||||||paired t-test|||Protein absorption at Week 4||||0.096
72595961|NCT04964986|144723419|SUPERIORITY|||||||0.075|||||||paired t-test|||Protein absorption at Week 48||||0.075
72595962|NCT04964986|144723420|SUPERIORITY|||||||0.063|||||||paired t-test|||Week 4||||0.063
72595963|NCT04964986|144723420|SUPERIORITY|||||||0.112|||||||paired t-test|||Week 48||||0.112
72595964|NCT04964986|144723421|SUPERIORITY|||||||0.306|||||||paired t-test|||||||0.306
72595965|NCT04964986|144723422|SUPERIORITY||Median Difference (Final Values)|0.3346||||0.704|TWO_SIDED|95.0|-0.7887|0.8748|||paired t-test||Based on one-sample (paired) Hodges-Lehmann median estimator for non-parametric estimate of change from baseline.|Calcium, Week 4||0.8748|-0.7887|0.704
72595966|NCT04964986|144723422|SUPERIORITY||Median Difference (Final Values)|-0.104||||0.488|TWO_SIDED|95.0|-2.7442|0.8896|||paired t-test||Based on one-sample (paired) Hodges-Lehmann median estimator for non-parametric estimate of change from baseline.|Calcium, Week 48||0.8896|-2.7442|0.488
72595967|NCT04964986|144723422|SUPERIORITY||Median Difference (Final Values)|-0.219||||0.382|TWO_SIDED|95.0|-0.896|0.313|||paired t-test||Based on one-sample (paired) Hodges-Lehmann median estimator for non-parametric estimate of change from baseline.|Magnesium, Week 4||0.313|-0.896|0.382
72595968|NCT04964986|144723422|SUPERIORITY||Median Difference (Final Values)|-1.566||||0.059|TWO_SIDED|95.0|-5.279|-0.165|||paired t-test||Based on one-sample (paired) Hodges-Lehmann median estimator for non-parametric estimate of change from baseline.|Magnesium, Week 48||-0.165|-5.279|0.059
72595969|NCT04964986|144723422|SUPERIORITY||Median Difference (Final Values)|33.116||||0.004|TWO_SIDED|95.0|5.51|51.861|||paired t-test||Based on one-sample (paired) Hodges-Lehmann median estimator for non-parametric estimate of change from baseline.|Sodium, Week 4||51.861|5.510|0.004
72595970|NCT04964986|144723422|SUPERIORITY||Median Difference (Final Values)|20.727||||0.337|TWO_SIDED|95.0|-27.758|55.828|||paired t-test||Based on one-sample (paired) Hodges-Lehmann median estimator for non-parametric estimate of change from baseline.|Sodium, Week 48||55.828|-27.758|0.337
72595971|NCT04964986|144723422|SUPERIORITY||Median Difference (Final Values)|1.618||||0.724|TWO_SIDED|95.0|-11.87|14.931|||paired t-test||Based on one-sample (paired) Hodges-Lehmann median estimator for non-parametric estimate of change from baseline.|Potassium, Week 4||14.931|-11.870|0.724
72595972|NCT04964986|144723422|SUPERIORITY||Median Difference (Final Values)|-9.19||||0.115|TWO_SIDED|95.0|-18.88|3.737|||paired t-test||Based on one-sample (paired) Hodges-Lehmann median estimator for non-parametric estimate of change from baseline.|Potassium, Week 48||3.737|-18.880|0.115
72595973|NCT04964986|144723422|SUPERIORITY||Median Difference (Final Values)|12.297||||0.707|TWO_SIDED|95.0|-39.551|52.617|||paired t-test||Based on one-sample (paired) Hodges-Lehmann median estimator for non-parametric estimate of change from baseline.|Urea, Week 4||52.617|-39.551|0.707
72595974|NCT04964986|144723422|SUPERIORITY||Mean Difference (Final Values)|-91.487||||0.009|TWO_SIDED|95.0|-159.956|-20.068|||paired t-test||Based on one-sample (paired) Hodges-Lehmann median estimator for non-parametric estimate of change from baseline.|Urea, Week 48||-20.068|-159.956|0.009
72595975|NCT04964986|144723422|SUPERIORITY||Median Difference (Final Values)|0.281||||0.572|TWO_SIDED|95.0|-0.649|0.96|||paired t-test||Based on one-sample (paired) Hodges-Lehmann median estimator for non-parametric estimate of change from baseline.|Creatinine, Week 4||0.960|-0.649|0.572
72595976|NCT04964986|144723422|SUPERIORITY||Median Difference (Final Values)|-0.136||||0.981|TWO_SIDED|95.0|-1.06|1.073|||paired t-test||Based on one-sample (paired) Hodges-Lehmann median estimator for non-parametric estimate of change from baseline.|Creatinine, Week 48||1.073|-1.060|0.981
72595977|NCT04964986|144723423|SUPERIORITY|||||||0.066|||||||paired t-test|||Week 24||||0.066
72595978|NCT04964986|144723423|SUPERIORITY|||||||0.015|||||||paired t-test|||Week 52||||0.015
72595979|NCT05821296|144723430|OTHER|Change of sum of total lesions at the end of the study from baseline/Day 0 to evaluate the efficacy and clinical performance of Crystal Peel for the treatment of acne.|Mean Difference (Final Values)|-14.58|STANDARD_ERROR_OF_MEAN|1.38|<|0.0001|TWO_SIDED|95.0|-17.31|-11.84|||ANCOVA|||||-11.84|-17.31|<0.0001
72595980|NCT05821296|144723431|OTHER||Mean Difference (Final Values)|1.85|STANDARD_DEVIATION|0.87|||TWO_SIDED|95.0|1.54|2.16||||||||2.16|1.54|
72595981|NCT05821296|144723432|OTHER||Mean Difference (Final Values)|1.82|STANDARD_DEVIATION|1.07|||TWO_SIDED|95.0|1.44|2.2||||||||2.20|1.44|
72595982|NCT05821296|144723433|OTHER||Mean value in local tolerance score|2.21|STANDARD_DEVIATION|0.65|||TWO_SIDED|95.0|1.98|2.44||||||||2.44|1.98|
72595983|NCT05821296|144723434|OTHER|Descriptive analysis of subjects' satisfaction questionnaire assessing the Crystal Peel in the treatment of acne.|% of patients with positive answers|79.0|||||TWO_SIDED|95.0|61.0|89.0||||||||89|61|
72595984|NCT05821296|144723434|OTHER||% of patients with positive answers|94.0|||||TWO_SIDED|95.0|80.0|98.0||||||Descriptive analysis of subjects' satisfaction questionnaire assessing the Crystal Peel in the treatment of acne.||98|80|
72595985|NCT05821296|144723434|OTHER||% of patients with positive answers|88.0|||||TWO_SIDED|95.0|73.0|95.0||||||Descriptive analysis of subjects' satisfaction questionnaire assessing the Crystal Peel in the treatment of acne.||95|73|
72595986|NCT05821296|144723434|OTHER||% of patients with positive answers|85.0|||||TWO_SIDED|95.0|68.0|93.0||||||Descriptive analysis of subjects' satisfaction questionnaire assessing the Crystal Peel in the treatment of acne.||93|68|
72595987|NCT05821296|144723434|OTHER||% of patients with positive answers|91.0|||||TWO_SIDED|95.0|77.0|97.0||||||Descriptive analysis of subjects' satisfaction questionnaire assessing the Crystal Peel in the treatment of acne.||97|77|
72595988|NCT05821296|144723434|OTHER||% of patients with positive answers|85.0|||||TWO_SIDED|95.0|69.0|93.0||||||Descriptive analysis of subjects' satisfaction questionnaire assessing the Crystal Peel in the treatment of acne.||93|69|
72595989|NCT05821296|144723434|OTHER||% of patients with positive answers|78.0|||||TWO_SIDED|95.0|61.0|89.0||||||Descriptive analysis of subjects' satisfaction questionnaire assessing the Crystal Peel in the treatment of acne.||89|61|
72595990|NCT05821296|144723434|OTHER||% of patients with positive answers|79.0|||||TWO_SIDED|95.0|62.0|89.0||||||Descriptive analysis of subjects' satisfaction questionnaire assessing the Crystal Peel in the treatment of acne.||89|62|
72595991|NCT05821296|144723434|OTHER||% of patients with positive answers|76.0|||||TWO_SIDED|95.0|59.0|87.0||||||Descriptive analysis of subjects' satisfaction questionnaire assessing the Crystal Peel in the treatment of acne.||87|59|
72595992|NCT05821296|144723436|OTHER||Mean Difference (Net)|-47.24|STANDARD_DEVIATION|56.61|<|0.0001|TWO_SIDED|||||If the test provides a p-value less than 0.05, there is a significant variation over time for the analyzed parameter.|t-test, 2 sided|||Comparison of change from baseline of conspicuous number of detected pores at day 15 to evaluate the improvement of pores assessed by Colorface device.||||< 0.0001
72595993|NCT05821296|144723436|OTHER||Mean Difference (Final Values)|-30.85|STANDARD_DEVIATION|63.92||0.01|TWO_SIDED|||||If the test provides a p-value less than 0.05, there is a significant variation over time for the analyzed parameter.|t-test, 2 sided|||Comparison of change from baseline of conspicuous number of detected pores at Day 36 to evaluate the improvement of pores assessed by Colorface device.||||0.010
72595994|NCT05821296|144723436|OTHER||Mean Difference (Final Values)|-41.69|STANDARD_DEVIATION|73.69|<|0.004|TWO_SIDED|||||If the test provides a p-value less than 0.05, there is a significant variation over time for the analyzed parameter.|t-test, 2 sided|||Comparison of change from baseline of conspicuous number of detected pores at Day 57 to evaluate the improvement of pores assessed by Colorface device.||||<0.004
72595995|NCT05821296|144723436|OTHER||Mean Difference (Final Values)|-29.13|STANDARD_DEVIATION|61.45||0.013|TWO_SIDED|||||If the test provides a p-value less than 0.05, there is a significant variation over time for the analyzed parameter.|t-test, 2 sided|||Comparison of change from baseline of conspicuous number of detected pores at day 78 to evaluate the improvement of pores assessed by Colorface device.||||0.013
72595996|NCT05821296|144723437|OTHER||Mean Difference (Final Values)|-2832.39|STANDARD_DEVIATION|3217.15|<|0.0001|TWO_SIDED|||||If the test provides a p-value less than 0.05, there is a significant variation over time for the analyzed parameter.|t-test, 2 sided|||Comparison of change from baseline of conspicuous area of detected pores at day 15 to evaluate the improvement of pores assessed by Colorface device.||||< 0.0001
72595997|NCT05821296|144723437|OTHER||Mean Difference (Final Values)|-1754.88|STANDARD_DEVIATION|4220.25||0.025|TWO_SIDED|||||If the test provides a p-value less than 0.05, there is a significant variation over time for the analyzed parameter.|t-test, 2 sided|||Comparison of change from baseline of conspicuous area of detected pores at day 36 to evaluate the improvement of pores assessed by Colorface device.||||0.025
72415290|NCT00295750|144341145|SUPERIORITY_OR_OTHER||Cumulative probability|85.9||||||95.0|79.9|90.2|||||95% confidence interval for the cumulative probability of completing the study without prostate specific antigen failure from Day 0 to Day 364.|||90.2|79.9|
72595998|NCT05821296|144723437|OTHER||Mean Difference (Final Values)|-2763.41|STANDARD_DEVIATION|4965.84||0.004|TWO_SIDED|||||If the test provides a p-value less than 0.05, there is a significant variation over time for the analyzed parameter.|t-test, 2 sided|||Comparison of change from baseline of conspicuous area of detected pores at day 57 to evaluate the improvement of pores assessed by Colorface device.||||0.004
72595999|NCT05821296|144723437|OTHER||Mean Difference (Final Values)|-1742.41|STANDARD_DEVIATION|3974.21||0.021|TWO_SIDED|||||If the test provides a p-value less than 0.05, there is a significant variation over time for the analyzed parameter.|t-test, 2 sided|||Comparison of change from baseline of conspicuous area of detected pores at day 78 to evaluate the improvement of pores assessed by Colorface device.||||0.021
72596000|NCT05821296|144723438|OTHER||Mean Difference (Final Values)|-1.2|STANDARD_DEVIATION|1.3|<|0.0001|TWO_SIDED|||||If the test provides a p-value less than 0.05, there is a significant variation over time for the analyzed parameter.|t-test, 2 sided|||Comparison of change from baseline of conspicuous relative area (density) of detected pores at Day 15 to evaluate the improvement of pores assessed by Colorface device.||||<0.0001
72596001|NCT05821296|144723438|OTHER||Mean Difference (Final Values)|-0.68|STANDARD_DEVIATION|1.68||0.029|TWO_SIDED|||||If the test provides a p-value less than 0.05, there is a significant variation over time for the analyzed parameter.|t-test, 2 sided|||Comparison of change from baseline of conspicuous relative area (density) of detected pores at Day 36 to evaluate the improvement of pores assessed by Colorface device.||||0.029
72596002|NCT05821296|144723438|OTHER||Mean Difference (Final Values)|-1.07|STANDARD_DEVIATION|2.01||0.006|TWO_SIDED|||||If the test provides a p-value less than 0.05, there is a significant variation over time for the analyzed parameter.|t-test, 2 sided|||Comparison of change from baseline of conspicuous relative area (density) of detected pores at Day 57 to evaluate the improvement of pores assessed by Colorface device.||||0.006
72596003|NCT05821296|144723438|OTHER||Mean Difference (Net)|-0.65|STANDARD_DEVIATION|1.67||0.037|TWO_SIDED|||||If the test provides a p-value less than 0.05, there is a significant variation over time for the analyzed parameter.|t-test, 2 sided|||Comparison of change from baseline of conspicuous relative area (density) of detected pores at Day 78 to evaluate the improvement of pores assessed by Colorface device.||||0.037
72596004|NCT05821296|144723439|OTHER||Mean Difference (Final Values)|-0.39|STANDARD_DEVIATION|0.58||0.001|TWO_SIDED|||||If the test provides a p-value less than 0.05, there is a significant variation over time for the analyzed parameter.|t-test, 2 sided|||Comparison of change from baseline of conspicuous depth of detected pores at Day 15 to evaluate the improvement of pores assessed by Colorface device.||||0.001
72596005|NCT05821296|144723439|OTHER||Mean Difference (Final Values)|-0.14|STANDARD_DEVIATION|0.71||0.348|TWO_SIDED|||||If the test provides a p-value less than 0.05, there is a significant variation over time for the analyzed parameter.|Wilcoxon (Mann-Whitney)|||Comparison of change from baseline of conspicuous depth of detected pores at Day 36 to evaluate the improvement of pores assessed by Colorface device.||||0.348
72596006|NCT05821296|144723439|OTHER||Mean Difference (Final Values)|-0.27|STANDARD_DEVIATION|0.75||0.091|TWO_SIDED|||||If the test provides a p-value less than 0.05, there is a significant variation over time for the analyzed parameter.|Wilcoxon (Mann-Whitney)|||Comparison of change from baseline of conspicuous depth of detected pores at Day 57 to evaluate the improvement of pores assessed by Colorface device.||||0.091
72596007|NCT05821296|144723439|OTHER||Mean Difference (Final Values)|-0.12|STANDARD_DEVIATION|0.65||0.19|TWO_SIDED|||||If the test provides a p-value less than 0.05, there is a significant variation over time for the analyzed parameter.|Wilcoxon (Mann-Whitney)|||Comparison of change from baseline of conspicuous depth of detected pores at Day 78 to evaluate the improvement of pores assessed by Colorface device.||||0.190
72596008|NCT05821296|144723440|OTHER||Mean Difference (Final Values)|-1.69|STANDARD_DEVIATION|3.55||0.011|TWO_SIDED|||||If the test provides a p-value less than 0.05, there is a significant variation over time for the analyzed parameter.|t-test, 2 sided|||Comparison of change from baseline of average area of detected pores at Day 15 to evaluate the improvement of pores assessed by Colorface device.||||0.011
72596009|NCT05821296|144723440|OTHER||Mean Difference (Final Values)|-0.64|STANDARD_DEVIATION|3.28||0.281|TWO_SIDED|||||If the test provides a p-value less than 0.05, there is a significant variation over time for the analyzed parameter.|t-test, 2 sided|||Comparison of change from baseline of average area of detected pores at Day 36 to evaluate the improvement of pores assessed by Colorface device.||||0.281
72596010|NCT05821296|144723440|OTHER||Mean Difference (Final Values)|-1.57|STANDARD_DEVIATION|4.46||0.06|TWO_SIDED|||||If the test provides a p-value less than 0.05, there is a significant variation over time for the analyzed parameter.|t-test, 2 sided|||Comparison of change from baseline of average area of detected pores at Day 57 to evaluate the improvement of pores assessed by Colorface device.||||0.060
72596011|NCT05821296|144723440|OTHER||Mean Difference (Final Values)|-0.87|STANDARD_DEVIATION|3.8||0.209|TWO_SIDED|||||If the test provides a p-value less than 0.05, there is a significant variation over time for the analyzed parameter.|t-test, 2 sided|||Comparison of change from baseline of average area of detected pores at Day 78 to evaluate the improvement of pores assessed by Colorface device.||||0.209
72596012|NCT05821296|144723441|OTHER||Mean Difference (Final Values)|-26495.83|STANDARD_DEVIATION|33223.6|<|0.0001|TWO_SIDED|||||If the test provides a p-value less than 0.05, there is a significant variation over time for the analyzed parameter.|Wilcoxon (Mann-Whitney)|||Comparison of change from baseline of conspicuous volume of detected pores at Day 15 to evaluate the improvement of pores assessed by Colorface device.||||<0.0001
72596013|NCT05821296|144723441|OTHER||Mean Difference (Final Values)|-14447.02|STANDARD_DEVIATION|44054.48||0.073|TWO_SIDED||||||t-test, 2 sided|||Comparison of change from baseline of conspicuous volume of detected pores at Day 36 to evaluate the improvement of pores assessed by Colorface device.||||0.073
72596014|NCT05821296|144723441|OTHER|If the test provides a p-value less than 0.05, there is a significant variation over time for the analyzed parameter.|Mean Difference (Final Values)|-25315.34|STANDARD_DEVIATION|49884.67||0.008|TWO_SIDED||||||t-test, 2 sided|||Comparison of change from baseline of conspicuous volume of detected pores at Day 57 to evaluate the improvement of pores assessed by Colorface device.||||0.008
72596015|NCT05821296|144723441|OTHER||Mean Difference (Final Values)|-13287.34|STANDARD_DEVIATION|39615.92||0.071|TWO_SIDED|||||If the test provides a p-value less than 0.05, there is a significant variation over time for the analyzed parameter.|t-test, 2 sided|||Comparison of change from baseline of conspicuous volume of detected pores at Day 78 to evaluate the improvement of pores assessed by Colorface device.||||0.071
72596016|NCT05821296|144723442|OTHER||Mean Difference (Final Values)|-7518.25|STANDARD_DEVIATION|13340.45||0.003|TWO_SIDED|||||If the Wilcoxon test provides a p-value less than 0.05, the variation is significant over time for the studied parameter.|Wilcoxon (Mann-Whitney)|||Comparison of change from baseline of conspicuous area of line marks at Day 15 to evaluate the improvement of line marks assessed by Colorface device.||||0.003
72596017|NCT05821296|144723442|OTHER||Mean Difference (Final Values)|-7230.81|STANDARD_DEVIATION|17547.6||0.041|TWO_SIDED|||||If the Wilcoxon test provides a p-value less than 0.05, the variation is significant over time for the studied parameter.|Wilcoxon (Mann-Whitney)|||Comparison of change from baseline of conspicuous area of line marks at Day 36 to evaluate the improvement of line marks assessed by Colorface device.||||0.041
72596018|NCT05821296|144723442|OTHER||Mean Difference (Final Values)|-9086.26|STANDARD_DEVIATION|18306.64||0.007|TWO_SIDED|||||If the Wilcoxon test provides a p-value less than 0.05, the variation is significant over time for the studied parameter.|Wilcoxon (Mann-Whitney)|||Comparison of change from baseline of conspicuous area of line marks at Day 57 to evaluate the improvement of line marks assessed by Colorface device.||||0.007
72596019|NCT05821296|144723442|OTHER||Mean Difference (Final Values)|64.71|STANDARD_DEVIATION|14542.17||0.931|TWO_SIDED|||||If the Wilcoxon test provides a p-value less than 0.05, the variation is significant over time for the studied parameter.|Wilcoxon (Mann-Whitney)|||Comparison of change from baseline of conspicuous area of line marks at Day 78 to evaluate the improvement of line marks assessed by Colorface device.||||0.931
72596020|NCT05821296|144723443|OTHER||Mean Difference (Final Values)|-0.36|STANDARD_DEVIATION|0.66||0.005|TWO_SIDED|||||If the test provides a p-value less than 0.05, the variation is significant over time for the studied parameter.|t-test, 2 sided|||Comparison of change from baseline of conspicuous depth of line marks at Day 15 to evaluate the improvement of line marks assessed by Colorface device.||||0.005
72596021|NCT05821296|144723443|OTHER||Mean Difference (Final Values)|-0.32|STANDARD_DEVIATION|0.8||0.035|TWO_SIDED|||||If the test provides a p-value less than 0.05, the variation is significant over time for the studied parameter.|t-test, 2 sided|||Comparison of change from baseline of conspicuous depth of line marks at Day 36 to evaluate the improvement of line marks assessed by Colorface device.||||0.035
72596022|NCT05821296|144723443|OTHER||Mean Difference (Final Values)|-0.34|STANDARD_DEVIATION|0.86||0.036|TWO_SIDED|||||If the test provides a p-value less than 0.05, the variation is significant over time for the studied parameter.|t-test, 2 sided|||Comparison of change from baseline of conspicuous depth of line marks at Day 57 to evaluate the improvement of line marks assessed by Colorface device.||||0.036
72596023|NCT05821296|144723443|OTHER||Mean Difference (Final Values)|0.04|STANDARD_DEVIATION|0.77||0.784|TWO_SIDED|||||If the test provides a p-value less than 0.05, the variation is significant over time for the studied parameter.|t-test, 2 sided|||Comparison of change from baseline of conspicuous depth of line marks at Day 78 to evaluate the improvement of line marks assessed by Colorface device.||||0.784
72596024|NCT05821296|144723444|OTHER||Mean Difference (Final Values)|-2249.72|STANDARD_DEVIATION|4466.14||0.011|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|If the test provides a p-value less than 0.05, the variation is significant over time for the studied parameter.||Comparison of change from baseline of conspicuous length of line marks at Day 15 to evaluate the improvement of line marks assessed by Colorface device.||||0.011
72415291|NCT01316926|144341207|NON_INFERIORITY_OR_EQUIVALENCE|This is a bioequivalence study. The study was performed to fulfill an official requirement of the Brazilian Regulatory Agency - ANVISA - upon manufacturing a site change.|Ratio T formulation/R formulation|0.9204|||||TWO_SIDED|90.0|0.8556|0.99|||||Coefficient Variation (intra-individual). The ratio between the geometric means of the test and reference formulations was calculated.|||0.9900|0.8556|
72415292|NCT01316926|144341208|NON_INFERIORITY_OR_EQUIVALENCE|This is a bioequivalence study. The study was performed to fulfill an official requirement of the Brazilian Regulatory Agency - ANVISA - upon manufacturing a site change.|Ratio T formulation/R formulation|0.941|||||TWO_SIDED|90.0|0.846|1.0467|||||Coefficient Variation (intra-individual). The ratio between the geometric means of the test and reference formulations was calculated.|||1.0467|0.8460|
72596025|NCT05821296|144723444|OTHER||Mean Difference (Final Values)|-2315.0|STANDARD_DEVIATION|6197.86||0.074|TWO_SIDED|||||If the test provides a p-value less than 0.05, the variation is significant over time for the studied parameter.|Wilcoxon (Mann-Whitney)|||Comparison of change from baseline of conspicuous length of line marks at Day 36 to evaluate the improvement of line marks assessed by Colorface device.||||0.074
72596026|NCT05821296|144723444|OTHER||Mean Difference (Final Values)|-2700.55|STANDARD_DEVIATION|5962.3||0.007|TWO_SIDED|||||If the test provides a p-value less than 0.05, the variation is significant over time for the studied parameter.|Wilcoxon (Mann-Whitney)|||Comparison of change from baseline of conspicuous length of line marks at Day 57 to evaluate the improvement of line marks assessed by Colorface device.||||0.007
72596027|NCT05821296|144723444|OTHER||Mean Difference (Final Values)|430.65|STANDARD_DEVIATION|5021.2||0.779|TWO_SIDED|||||If the test provides a p-value less than 0.05, the variation is significant over time for the studied parameter.|Wilcoxon (Mann-Whitney)|||Comparison of change from baseline of conspicuous length of line marks at Day 78 to evaluate the improvement of line marks assessed by Colorface device.||||0.779
72596028|NCT05821296|144723445|OTHER||Mean Difference (Final Values)|-75800.75|STANDARD_DEVIATION|142643.92||0.003|TWO_SIDED|||||If the test provides a p-value less than 0.05, the variation is significant over time for the studied parameter.|Wilcoxon (Mann-Whitney)|||Comparison of change from baseline of conspicuous volume of line marks at Day 15 to evaluate the improvement of line marks assessed by Colorface device.||||0.003
72596029|NCT05821296|144723445|OTHER||Mean Difference (Final Values)|-73517.86|STANDARD_DEVIATION|197224.85||0.054|TWO_SIDED|||||If the test provides a p-value less than 0.05, the variation is significant over time for the studied parameter.|Wilcoxon (Mann-Whitney)|||Comparison of change from baseline of conspicuous volume of line marks at Day 36 to evaluate the improvement of line marks assessed by Colorface device.||||0.054
72596030|NCT05821296|144723445|OTHER||Mean Difference (Final Values)|-90424.89|STANDARD_DEVIATION|198264.2||0.008|TWO_SIDED|||||If the test provides a p-value less than 0.05, the variation is significant over time for the studied parameter.|Wilcoxon (Mann-Whitney)|||Comparison of change from baseline of conspicuous volume of line marks at Day 57 to evaluate the improvement of line marks assessed by Colorface device.||||0.008
72596031|NCT05821296|144723445|OTHER||Mean Difference (Final Values)|1314.03||||0.779|TWO_SIDED||||||t-test, 2 sided|||Comparison of change from baseline of conspicuous volume of line marks at Day 78 to evaluate the improvement of line marks assessed by Colorface device.||||0.779
72596032|NCT00497770|144723461|NON_INFERIORITY_OR_EQUIVALENCE|A pre-specified logistic regression was used to assess non-inferiority of DCR in African American participants compared with Caucasian participants. The DCR for African Americans was to be considered non-inferior to the DCR for Caucasians if the upper bound of the confidence interval (CI) of the odds ratio (OR) for African American versus Caucasian was \<1.78 which corresponds to a difference in proportions of approximately 14% assuming the DCR in the reference group to be 50%.|Odds Ratio (OR)|0.821|||||TWO_SIDED|95.0|0.427|1.58||Adjusted:baseline characteristics, income, marital/insurance status, comorbid, time between end of 1st line therapy and start of pemetrexed, prior platinum- or Paclitaxel-containing regimen, number of cycles and best response during 1st line therapy.|Regression, Logistic|||||1.580|0.427|
72596033|NCT01782352|144723476|SUPERIORITY||Hazard Ratio (HR)|1.02|||<|0.05|TWO_SIDED|95.0|0.82|1.27|||Regression, Cox|||||1.27|0.82|<0.05
72596034|NCT01782352|144723476|SUPERIORITY||Hazard Ratio (HR)|0.94|||<|0.05|TWO_SIDED|95.0|0.76|1.17|||Regression, Cox|||||1.17|0.76|<0.05
72415293|NCT01316926|144341209|NON_INFERIORITY_OR_EQUIVALENCE|This is a bioequivalence study. The study was performed to fulfill an official requirement of the Brazilian Regulatory Agency - ANVISA - upon manufacturing a site change.|Ratio T formulation/R formulation|0.9333|||||TWO_SIDED|90.0|0.8502|1.0246|||||Coefficient Variation (intra-individual). The ratios between the geometric means of the test and reference formulations was calculated.|||1.0246|0.8502|
72596035|NCT01782352|144723477|SUPERIORITY||Hazard Ratio (HR)|1.21|||<|0.05|TWO_SIDED|95.0|0.86|1.7|||Regression, Cox|||||1.70|0.86|<0.05
72596036|NCT01782352|144723477|SUPERIORITY||Hazard Ratio (HR)|0.84|||<|0.05|TWO_SIDED|95.0|0.59|1.17|||Regression, Cox|||||1.17|0.59|<0.05
72596037|NCT01782352|144723478|SUPERIORITY||Hazard Ratio (HR)|1.23|||<|0.05|TWO_SIDED|95.0|0.81|1.84|||Regression, Cox|||||1.84|0.81|<0.05
72596038|NCT01782352|144723478|SUPERIORITY||Hazard Ratio (HR)|0.72|||<|0.05|TWO_SIDED|95.0|0.48|1.09|||Regression, Cox|||||1.09|0.48|<0.05
72596039|NCT01782352|144723479|SUPERIORITY||Hazard Ratio (HR)|1.09|||<|0.05|TWO_SIDED|95.0|0.86|1.37|||Regression, Cox|||||1.37|0.86|<0.05
72596040|NCT01782352|144723479|SUPERIORITY||Hazard Ratio (HR)|0.93|||<|0.05|TWO_SIDED|95.0|0.73|1.17|||Regression, Cox|||||1.17|0.73|<0.05
72596041|NCT01782352|144723480|SUPERIORITY||Hazard Ratio (HR)|0.63|||<|0.05|TWO_SIDED|95.0|0.33|1.21|||Regression, Cox|||||1.21|0.33|<0.05
72596042|NCT01782352|144723480|SUPERIORITY||Hazard Ratio (HR)|1.05|||<|0.05|TWO_SIDED|95.0|0.56|1.97|||Regression, Cox|||||1.97|0.56|<0.05
72596043|NCT01782352|144723481|SUPERIORITY||Hazard Ratio (HR)|0.93|||<|0.05|TWO_SIDED|95.0|0.69|1.25|||Regression, Cox|||||1.25|0.69|<0.05
72596044|NCT01782352|144723481|SUPERIORITY||Hazard Ratio (HR)|0.9|||<|0.05|TWO_SIDED|95.0|0.67|1.21|||Regression, Cox|||||1.21|0.67|<0.05
72596045|NCT01085136|144723507|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.61||||0.003|TWO_SIDED|95.0|0.44|0.85||P-value is calculated from two-sided stratified log-rank test|stratified log-rank test|||Hazard ratio is calculated from Cox proportional hazard model with treatment as the only factor, stratified by gender and maximum duration of erlotinib or gefitinib (\<6 months vs \>=6 months).||0.85|0.44|0.0030
72596046|NCT01085136|144723509|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.04||||0.7905|TWO_SIDED|95.0|0.76|1.44|||Stratified log-rank test.|P-value is calculated from two-sided stratified log-rank test.||Hazard ratio was calculated from Cox proportional hazard model with treatment as the only factor, stratified by gender and maximum duration of erlotinib or gefitinib (\<6 months vs \>=6 months).||1.44|0.76|0.7905
72596047|NCT01085136|144723511|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.98||||0.0065|TWO_SIDED|95.0|1.357|6.543|||Regression, Logistic|||Odds ratio, 95% Confidence Interval (CI) and p-value (two-sided) from logistic regression stratified for maximum treatment duration of prior erlotinib or gefitinib (\>=6 months vs \<6 months) and gender.||6.543|1.357|0.0065
72596048|NCT02301039|144723573|SUPERIORITY|An objective response rate of 25% will be considered clinically meaningful and a response rate less than 10% will be considered lack of efficacy. The treatment will be considered a success if 8 or more of 40 enrolled patients have a PR or better by RECIST 1.1.|Binomial estimate of response rate of PR|17.5|||||TWO_SIDED|95.0|7.3|32.8|||||Clopper-Pearson (Exact) Confidence Interval. Excluded from rate due to no response evaluation: Soft Tissue: 2; Bone: 2; Expansion: 7 patients|An objective response rate of 25% will be considered clinically meaningful and a response rate less than 10% will be considered lack of efficacy. The treatment will be considered a success if 8 or more of 40 enrolled patients have a PR or better by RECIST 1.1.||32.8|7.3|
72596049|NCT02301039|144723573|SUPERIORITY||Binomial estimate of response rate of PR|5.0|||||TWO_SIDED|95.0|1.0|16.9|||||Clopper-Pearson exact confidence interval; Excluded from rate due to no response evaluation: Soft Tissue: 2; Bone: 2; Expansion: 7 patients|An objective response rate of 25% will be considered clinically meaningful and a response rate less than 10% will be considered lack of efficacy. The treatment will be considered a success if 8 or more of 40 enrolled patients have a PR or better by RECIST 1.1.||16.9|1.0|
72596050|NCT02301039|144723573|SUPERIORITY||Binomial estimate of response rate of PR|13.0|||||TWO_SIDED|95.0|5.5|25.3|||||Clopper-Pearson (Exact) Confidence Interval Excluded from rate due to no response evaluation: Soft Tissue: 2; Bone: 2; Expansion: 7 patients|An objective response rate of 25% will be considered clinically meaningful and a response rate less than 10% will be considered lack of efficacy. The treatment will be considered a success if 8 or more of 40 enrolled patients have a PR or better by RECIST 1.1.||25.3|5.5|
72596051|NCT00135356|144723658|SUPERIORITY_OR_OTHER||Difference in Means|0.03||||0.48||95.0|-0.06|0.12||P-value not adjusted for multiple testing, 2-sided 95% CI|t-test, 2 sided|||LOCF||0.12|-0.06|0.48
72596052|NCT00135356|144723658|SUPERIORITY_OR_OTHER||Difference in Means|0.07||||0.57||95.0|-0.07|12.0||P-value not adjusted for multiple testing. 2-sided 95% CI|t-test, 2 sided|||OC||12.0|-0.07|0.57
72596053|NCT00135356|144723659|SUPERIORITY_OR_OTHER||Difference in Means|0.02||||0.73||95.0|-0.1|0.14||P-value not adjusted for multiple testing, 2-sided 95% CI.|t-test, 2 sided|||LOCF||0.14|-0.10|0.73
72596054|NCT00135356|144723659|SUPERIORITY_OR_OTHER||Difference in Means|-0.01||||0.91||95.0|-0.14|0.13||P-value not adjusted for multiple testing, 2-sided 95% CI.|t-test, 2 sided|||OC||0.13|-0.14|0.91
72596055|NCT00135356|144723660|SUPERIORITY_OR_OTHER||Difference in Mean|5.2||||0.27||95.0|-3.9|15.1||P-value not adjusted for multiple testing, 2-sided 95% CI.|t-test, 2 sided|||Week 48 VAT LOCF||15.1|-3.9|0.27
72596056|NCT00135356|144723660|SUPERIORITY_OR_OTHER||Difference in Mean|1.8||||0.68||95.0|-6.7|11.2||P-value not adjusted for multiple testing, 2-sided 95% CI|t-test, 2 sided|||VAT, Week 96 LOCF||11.2|-6.7|0.68
72596057|NCT00135356|144723660|SUPERIORITY_OR_OTHER||Difference in Means|4.4||||0.14||95.0|-1.4|10.6||P-value not adjusted for multiple testing, 2-sided 95% CI.|t-test, 2 sided|||Week 48 Trunk Fat LOCF||10.6|-1.4|0.14
72596058|NCT00135356|144723660|SUPERIORITY_OR_OTHER||Difference in Means|5.3||||0.14||95.0|-1.7|12.9||P-value not adjusted for multiple testing, 2-sided 95% CI.|t-test, 2 sided|||Week 96 Trunk Fat LOCF||12.9|-1.7|0.14
72596059|NCT00135356|144723661|SUPERIORITY_OR_OTHER||Difference in Means|4.0||||0.16||95.0|-1.6|10.0||P-value not adjusted for multiple testing, 2-sided 95% CI.|t-test, 2 sided|||SAT, Week 48, LOCF||10.0|-1.6|0.16
72596060|NCT00135356|144723661|SUPERIORITY_OR_OTHER||Difference in Mean|6.8||||0.06||95.0|-0.2|14.2||P-value not adjusted for multiple testing, 2-sided 95% CI.|t-test, 2 sided|||Week 96 SAT||14.2|-0.2|0.06
72596061|NCT00135356|144723661|SUPERIORITY_OR_OTHER||Difference in Means|4.6||||0.15||95.0|-1.7|11.4||P-value not adjusted for multiple testing, 2-sided 95% CI.|t-test, 2 sided|||Week 48, Limb Fat||11.4|-1.7|0.15
72596062|NCT00135356|144723661|SUPERIORITY_OR_OTHER||Difference in Means|5.7||||0.17||95.0|-2.3|14.4||P-value not adjusted for multiple testing, 2-sided 95% CI|t-test, 2 sided|||Week 96, Limb Fat||14.4|-2.3|0.17
72596063|NCT00135356|144723662|SUPERIORITY_OR_OTHER||DIfference in Means|3.6||||0.19||95.0|-1.8|9.4||P-value not adjusted for multiple testing, 2-sided 95% CI.|t-test, 2 sided|||Week 48 TAT||9.4|-1.8|0.19
72596064|NCT00135356|144723662|SUPERIORITY_OR_OTHER||DIfference in Means|4.3||||0.16||95.0|-1.7|10.7||P-value not adjusted for multiple testing, 2-sided 95% CI.|Wilcoxon (Mann-Whitney)|||Week 96 TAT||10.7|-1.7|0.16
72596065|NCT00135356|144723662|SUPERIORITY_OR_OTHER||Difference in Means|5.0||||0.0385||95.0|0.3|9.7||P-value not adjusted for multiple testing, 2-sided 95% CI.|t-test, 2 sided|||Week 48 Total Body Fat||9.7|0.3|0.0385
72596066|NCT00135356|144723662|SUPERIORITY_OR_OTHER||Difference in Means|5.9||||0.1||95.0|-1.0|13.2||P-value not adjusted for multiple testing, 2-sided 95% CI.|t-test, 2 sided|||Week 96 Total Body Fat||13.2|-1.0|0.10
72596067|NCT00135356|144723674|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.06|||||TWO_SIDED|95.0|0.3|3.72||||||||3.72|0.3|
72596068|NCT00253370|144723678|SUPERIORITY_OR_OTHER||proportion of participants|0.409||||0.0012|TWO_SIDED|90.0|0.284|0.544|||one-sample binomial test|||The study was designed to distinguish a response rate of 40% from 20%, the null hypothesis. With the planned sample size of 36 eligible patients, the study has 91% power based on a 0.09 level one-sided test.||0.544|0.284|0.0012
72596069|NCT01211483|144723689|SUPERIORITY||Hazard Ratio (HR)|0.978|||||TWO_SIDED|95.0|0.674|1.42||||||||1.420|0.674|
72596070|NCT01211483|144723689|SUPERIORITY||Hazard Ratio (HR)|0.77|||||TWO_SIDED|95.0|0.523|1.131||||||||1.131|0.523|
72596071|NCT01211483|144723690|SUPERIORITY||Hazard Ratio (HR)|0.369||||0.0185|TWO_SIDED|95.0|0.161|0.846|||Cox proportional hazard|||||0.846|0.161|0.0185
72596072|NCT01211483|144723690|SUPERIORITY||Hazard Ratio (HR)|0.288||||0.0034|TWO_SIDED|95.0|0.125|0.663|||Cox proportional hazard|||||0.663|0.125|0.0034
72596073|NCT01211483|144723691|SUPERIORITY||Hazard Ratio (HR)|1.006||||0.9879|TWO_SIDED|95.0|0.458|2.212|||Cox proportional hazard|||||2.212|0.458|0.9879
72596074|NCT01211483|144723691|SUPERIORITY||Hazard Ratio (HR)|1.222||||0.6276|TWO_SIDED|95.0|0.544|2.746|||Cox proportional hazard|||||2.746|0.544|0.6276
72596075|NCT02470403|144723729|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-5.7|||<|0.001|TWO_SIDED|80.0|-6.52|-4.87|||Mixed Models Analysis|||"This analysis included all subjects. The following criteria were assessed:~1. upper confidence limit of the 80% CI for treatment difference (LIK066 - placebo) was less than 0, and~2. estimated mean treatment difference was less than or equal to -5%. The first criterion addressed whether, with high certainty, there was superior weight loss in LIK066 treated group compared to placebo. The second criterion addressed whether observed mean reduction in body weight over placebo was at least 5%."||-4.87|-6.52|<0.001
72596076|NCT02470403|144723729|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-6.85|||<|0.001|TWO_SIDED|80.0|-7.96|-5.73|||Mixed Models Analysis|||"This analysis included dysglycemic subjects. The following criteria were assessed:~1. upper confidence limit of 80% CI for treatment difference was less than 0, and~2. estimated mean treatment difference was less than or equal to -5%. The first criterion addressed whether, with high certainty, there was superior weight loss in LIK066 treated group compared to placebo. The second criterion addressed whether observed mean reduction in body weight over placebo was at least 5%."||-5.73|-7.96|<0.001
72596077|NCT02470403|144723729|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-4.55|||<|0.001|TWO_SIDED|80.0|-5.76|-3.34|||Mixed Models Analysis|||"This analysis included normoglycemic subjects. The following criteria were assessed:~1. upper confidence limit of 80% CI for treatment difference was less than 0, and~2. estimated mean treatment difference was less than or equal to -5%. The first criterion addressed whether, with high certainty, there was superior weight loss in LIK066 treated group compared to placebo. The second criterion addressed whether observed mean reduction in body weight over placebo was at least 5%."||-3.34|-5.76|<0.001
72596078|NCT02470403|144723731|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-1.83|||<|0.001|TWO_SIDED|80.0|-2.16|-1.51|||Mixed Models Analysis|||"This analysis on all subjects. The following criteria were assessed:~1. upper confidence limit of 80% CI for treatment difference was less than 0, and~2. estimated mean treatment difference was less than or equal to -5%. The first criterion addressed whether, with high certainty, there was superior weight loss in LIK066 treated group compared to placebo. The second criterion addressed whether observed mean reduction in body weight over placebo was at least 5%."||-1.51|-2.16|<0.001
72596079|NCT02470403|144723731|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-2.39|||<|0.001|TWO_SIDED|80.0|-2.94|-1.84|||Mixed Models Analysis|||"This analysis on all subjects. The following criteria were assessed:~1. upper confidence limit of 80% CI for treatment difference was less than 0, and~2. estimated mean treatment difference was less than or equal to -5%. The first criterion addressed whether, with high certainty, there was superior weight loss in LIK066 treated group compared to placebo. The second criterion addressed whether observed mean reduction in body weight over placebo was at least 5%."||-1.84|-2.94|<0.001
72596080|NCT02470403|144723731|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-2.38|||<|0.001|TWO_SIDED|80.0|-2.93|-1.83|||Mixed Models Analysis|||"This analysis on all subjects. The following criteria were assessed:~1. upper confidence limit of 80% CI for treatment difference was less than 0, and~2. estimated mean treatment difference was less than or equal to -5%. The first criterion addressed whether, with high certainty, there was superior weight loss in LIK066 treated group compared to placebo. The second criterion addressed whether observed mean reduction in body weight over placebo was at least 5%"||-1.83|-2.93|<0.001
72596081|NCT00904839|144723746|SUPERIORITY_OR_OTHER||Difference|-8.1|||||TWO_SIDED|95.0|-27.8|11.5|||Kaplan-Meier||Difference in Kaplan-Meier Progression-free Survival Rates at 9 Months using Peto´s variance estimate.|||11.5|-27.8|
72596082|NCT00904839|144723751|SUPERIORITY_OR_OTHER||Difference|-5.0|||||TWO_SIDED|95.0|-15.3|5.2|||Kaplan-Meier||confidence interval includes 0, meaning that the null hypothesis (no difference between the 2 groups) cannot be rejected (i.e. pvalue \> 0.05). The pvalue was not computed. Difference in Kaplan-Meier Resection Rates using Peto´s variance estimate.|||5.2|-15.3|
72415294|NCT00765193|144341226|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.36|||<|0.01||95.0|2.12|2.62|||Regression, Logistic|||The primary outcomes were the calculation of the absolute and relative risks of missing a skin cancer when TBSE is not performed, as well as the number of patients needed to examine by TBSE to find a skin cancer. The secondary outcome was to assess the magnitude of false-positive results obtained by TBSE||2.62|2.12|<0.01
72415295|NCT02693665|144341315|SUPERIORITY|First measure of congruence was taken at 2 weeks post-baseline for controls, or immediately post-Session 2 for intervention dyads. Analysis presented here assessed differences between groups in agreement. This represents the underlying data without examining the pattern of congruence for each dyad over time. Longitudinal latent class analysis of congruence in responses over time between adolescents/families was conducted at the person not variable level.|Odds Ratio (OR)|3.22|||<|0.05|TWO_SIDED|95.0|1.09|9.57|||longitudinal latent class analysis|examined the pattern of change over time.||"Analysis was at the level of the dyad. AIM 1. To evaluate the efficacy of FACE-TC on patient-family congruence in treatment preferences.~H1a: FACE-TC participants will better maintain congruence over time, compared to controls.~H1b: Development of congruence may not be homogeneous and FACE-TC may influence the pattern of congruence development."||9.57|1.09|<0.05
72596083|NCT00553358|144723764|SUPERIORITY_OR_OTHER_LEGACY||Percentage of participants with pCR|-4.85||||0.3416|TWO_SIDED|97.5|-17.6|8.16|||Binomial|Binomial p-value for Trastuzumab 2 mg/kg versus Lapatinib 1500 mg|Estimation Comments: Estimated value is the difference in the percentage of participants with pCR: Arm1 (Lapatinib 1500 mg) minus Arm2 (Trastuzumab 2 mg/kg).|||8.16|-17.6|0.3416
72596084|NCT00553358|144723764|SUPERIORITY_OR_OTHER_LEGACY||Percentage of participants with pCR|21.79||||0.0001|TWO_SIDED|97.5|9.08|34.23|||Binomial|Binomial p-value for Trastuzumab 2 mg/kg versus Lapatinib 1000/750 mg + Trastuzumab 2 mg/kg|Estimation Comments: Estimated value is the difference in the percentage of participants with pCR: Arm3 (Lapatinib 1000/750 mg + Trastuzumab 2 mg/kg) minus Arm2 (Trastuzumab 2 mg/kg)|||34.23|9.08|0.0001
72596085|NCT00553358|144723772|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.878||||0.548|TWO_SIDED|95.0|0.57|1.34||The two-sided stratified log-rank test was implemented as the score test from the Cox model.|Regression, Cox||Cox models (Cox, 1972), with the stratification factors entered as strata variables, were used to calculate hazard ratios and corresponding confidence intervals for the pairwise comparisons of individual treatment arms with the trastuzumab alone arm.|||1.34|0.57|0.548
72596086|NCT00553358|144723772|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.005||||0.981|TWO_SIDED|95.0|0.66|1.52||The two-sided stratified log-rank test was implemented as the score test from the Cox model.|Regression, Cox||Cox models (Cox, 1972), with the stratification factors entered as strata variables, were used to calculate hazard ratios and corresponding confidence intervals for the pairwise comparisons of individual treatment arms with the trastuzumab alone arm.|||1.52|0.66|0.981
72596087|NCT00553358|144723774|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.788||||0.379|TWO_SIDED|95.0|0.46|1.34||The two-sided stratified log-rank test was implemented as the score test from the Cox model.|Regression, Cox||Cox models (Cox, 1972), with the stratification factors entered as strata variables, were used to calculate hazard ratios and corresponding confidence intervals for the pairwise comparisons of individual treatment arms with the trastuzumab alone arm.|||1.34|0.46|0.379
72596088|NCT00553358|144723774|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.962||||0.88|TWO_SIDED|95.0|0.58|1.6||The two-sided stratified log-rank test was implemented as the score test from the Cox model.|Regression, Cox||Cox models (Cox, 1972), with the stratification factors entered as strata variables, were used to calculate hazard ratios and corresponding confidence intervals for the pairwise comparisons of individual treatment arms with the trastuzumab alone arm.|||1.60|0.58|0.880
72596089|NCT00553358|144723775|SUPERIORITY||Hazard Ratio (HR)|0.481||||0.00079|TWO_SIDED|95.0|0.31|0.73|||Regression, Cox||Cox models (Cox, 1972), with the stratification factors entered as strata variables, were used to calculate a hazard ratio and corresponding confidence interval comparing pCR and no pCR.|Overall - All subjects in the EFS landmark analysis||0.73|0.31|0.00079
72596090|NCT00553358|144723775|SUPERIORITY||Hazard Ratio (HR)|0.35||||0.004|TWO_SIDED|95.0|0.16|0.71|||Regression, Cox||Cox models (Cox, 1972), with the stratification factors entered as strata variables, were used to calculate a hazard ratio and corresponding confidence interval comparing pCR and no pCR.|Subjects in the EFS landmark analysis in the lapatinib + trastuzumab arm||0.71|0.16|0.004
72596091|NCT00553358|144723775|SUPERIORITY||Hazard Ratio (HR)|0.532||||0.134|TWO_SIDED|95.0|0.21|1.16|||Regression, Cox||Cox models (Cox, 1972), with the stratification factors entered as strata variables, were used to calculate a hazard ratio and corresponding confidence interval comparing pCR and no pCR.|Subjects in the EFS landmark analysis in the lapatinib arm||1.16|0.21|0.134
72596092|NCT00553358|144723775|SUPERIORITY||Hazard Ratio (HR)|0.601||||0.163|TWO_SIDED|95.0|0.28|1.2|||Regression, Cox||Cox models (Cox, 1972), with the stratification factors entered as strata variables, were used to calculate a hazard ratio and corresponding confidence interval comparing pCR and no pCR.|Subjects in the EFS landmark analysis in the trastuzumab arm||1.20|0.28|0.163
72596093|NCT00553358|144723777|SUPERIORITY||Hazard Ratio (HR)|0.366||||0.00041|TWO_SIDED|95.0|0.2|0.63|||Regression, Cox||Cox models (Cox, 1972), with the stratification factors entered as strata variables, were used to calculate a hazard ratio and corresponding confidence interval comparing pCR and no pCR.|Overall - All subjects in the OS landmark analysis||0.63|0.20|0.00041
72596094|NCT00553358|144723777|SUPERIORITY||Hazard Ratio (HR)|0.223||||0.002|TWO_SIDED|95.0|0.07|0.58|||Regression, Cox||Cox models (Cox, 1972), with the stratification factors entered as strata variables, were used to calculate a hazard ratio and corresponding confidence interval comparing pCR and no pCR.|Subjects in the OS landmark analysis in the lapatinib + trastuzumab arm||0.58|0.07|0.002
72596095|NCT00553358|144723777|SUPERIORITY||Hazard Ratio (HR)|0.433||||0.125|TWO_SIDED|95.0|0.12|1.17|||Regression, Cox||Cox models (Cox, 1972), with the stratification factors entered as strata variables, were used to calculate a hazard ratio and corresponding confidence interval comparing pCR and no pCR.|Subjects in the OS landmark analysis in the lapatinib arm||1.17|0.12|0.125
72596096|NCT00553358|144723777|SUPERIORITY||Hazard Ratio (HR)|0.414||||0.058|TWO_SIDED|95.0|0.15|1.0|||Regression, Cox||Cox models (Cox, 1972), with the stratification factors entered as strata variables, were used to calculate a hazard ratio and corresponding confidence interval comparing pCR and no pCR.|Subjects in the OS landmark analysis in the trastuzumab arm||1.00|0.15|0.058
72596097|NCT03887429|144723815|SUPERIORITY||||||=|0.009|||||||t-test, 1 sided|||It was hypothesized that treatment with SXC-2023 would reduce impulsivity as measured by SSRT in chronic cigarette smokers abstaining from nicotine for 5 days.||||=.009
72596098|NCT03887429|144723816|SUPERIORITY||||||=|0.015|||||||t-test, 1 sided|||It was hypothesized that 5 days of nicotine abstinence in chronic cigarette smokers would result in increased risk taking behavior as measured using DAVT in subjects receiving placebo as treatment.||||=.015
72596099|NCT03887429|144723816|SUPERIORITY||||||>|0.1|||||||t-test, 1 sided|||It was hypothesized that 5 days of nicotine abstinence in chronic cigarette smokers would not result in increased risk taking behavior as measured using DAVT in subjects treated with SXC-2023.||||>.1
72596100|NCT02943785|144723824|NON_INFERIORITY|The two-sided p-value (Noninferiority) was based on the noninferiority margin of 1.38.|Cox Proportional Hazard|1.05||||0.0141|TWO_SIDED|95.0|0.85|1.31|||Regression, Cox|||||1.31|0.85|0.0141
72596101|NCT02943785|144723825|NON_INFERIORITY|The two-sided p-value (Noninferiority) was based on the noninferiority margin of 1.38.|Cox Proportional Hazard|1.4||||0.9267|TWO_SIDED|95.0|1.03|1.91|||Regression, Cox|||||1.91|1.03|0.9267
72596102|NCT01490697|144723899|SUPERIORITY||Mean Difference (Final Values)|-1.0|||||TWO_SIDED|95.0|-18.0|16.0|||||Placebo plus Placebo - Mifepristone plus d-Cycloserine (DCS)|||16|-18|
72596103|NCT01490697|144723900|SUPERIORITY||Mean Difference (Net)|3.9|||||TWO_SIDED|95.0|-6.9|14.7|||||Placebo plus Placebo - Mifepristone plus d-Cycloserine (DCS)|||14.7|-6.9|
72596104|NCT00090584|144723901|SUPERIORITY_OR_OTHER||Difference in cumulative success rates|0.0|STANDARD_ERROR_OF_MEAN|0.06||0.74|TWO_SIDED|95.0|-0.12|0.12|||Log Rank|||Kaplan Meier Lifetable analysis was used to compute the 8 month cumulative success rates.||0.12|-0.12|0.74
72596105|NCT00090584|144723902|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.9|STANDARD_ERROR_OF_MEAN|2.0||0.34|TWO_SIDED|95.0|-2.0|5.9||Mixed effect repeated measures analysis of variance controlling for study site.|ANOVA|||Test of hypothesis of no difference in change in episodes between the two groups.||5.9|-2.0|0.34
72596106|NCT00090584|144723903|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.8|STANDARD_ERROR_OF_MEAN|0.5||0.08|TWO_SIDED|95.0|-1.7|0.1||Repeated measures ANOVA controlling for clinical site.|ANOVA||Difference (group 1 - group 2) in change from baseline to follow-up in voids per day.|Null hypothesis of no difference between arms in change in number of voids per day from baseline to 10 weeks.||0.1|-1.7|0.08
72596107|NCT00090584|144723904|SUPERIORITY_OR_OTHER||Other|0.0||||0.0006||95.0||||Repeated measures ANOVA|Mixed Models Analysis|Main hypothesis tested by F-test for treatment by time interaction (2 and 509 degrees of freedom). No parameters estimated.||Null hypothesis is that there is no difference between treatment groups in improvement in UDI over time||||0.0006
72596108|NCT00090584|144723905|SUPERIORITY_OR_OTHER||Other|0.0||||0.0005||95.0||||P-value for test of time by treatment group interaction.|Mixed Models Analysis|Adjusted for study site||Repeated measures analysis of difference in symptom bother over time by treatment group.||||0.0005
72596109|NCT00090584|144723906|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.79||||0.02|TWO_SIDED|95.0|1.09|2.92|||Regression, Logistic|Controlling for clinical site and randomization stratum|Ratio of odds of complete satisfaction in Combination therapy arm to Drug only arm.|Null hypothesis: no difference in satisfaction at 10 weeks||2.92|1.09|0.02
72596110|NCT00090584|144723907|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.03||||0.02|TWO_SIDED|95.0|1.11|3.7|||Regression, Logistic|Controlling for clinical site and randomization stratum|Ratio of odds of complete satisfaction in combination therapy group compared to drug only group.|Null hypothesis: No difference in satisfaction at 8 months post intervention||3.70|1.11|0.02
72596111|NCT00090584|144723908|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.55||||0.008|TWO_SIDED|95.0|1.27|5.13||P-value from logistic regression analysis|Regression, Logistic|Controlling for clinical site and randomization stratum||Null hypothesis: No difference in perceived improvement between women in combination therapy group compared to those in drug only group||5.13|1.27|0.008
72596112|NCT00090584|144723909|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.17|||<|0.0001|TWO_SIDED|95.0|1.83|5.52|||Regression, Logistic|Controlling for clinical site and randomization stratum||Null hypothesis: No difference in perceived improvement at 8 months between women in combination therapy group compared to those in drug only group.||5.52|1.83|<0.0001
72596113|NCT03409120|144723910|SUPERIORITY||||||<|0.001|||||||linear mixed effects model|||We tested the equivalence of Burke-Fahn-Marsden scores over time (at baseline and at two time periods following DBS surgery) using a repeated measures ANOVA.||||<0.001
72596114|NCT02117713|144723934|EQUIVALENCE|Student's t-test used to test if mean change is statistically significant; null hypothesis is that the mean change from baseline is equal to zero.|Mean Difference (Net)|-28.59|STANDARD_DEVIATION|89.456||0.1157|TWO_SIDED|95.0|-64.72|7.54|||Student's t-test||Difference is only calculated in participants who had baseline and week 48 values for n= 26|||7.54|-64.72|0.1157
72596115|NCT02117713|144723935|EQUIVALENCE|Student's t-test used to test if mean change is statistically significant; null hypothesis is that the mean change from baseline is equal to zero.|Mean Difference (Net)|-45.15|STANDARD_DEVIATION|89.934||0.1469|TWO_SIDED|95.0|-109.48|19.19|||Student's t-test||||Difference is only calculated in participants who had baseline and week 216 values for n=10|19.19|-109.48|0.1469
72596116|NCT02117713|144723936|EQUIVALENCE|Student's t-test was used to test if mean change was statistically significant (null hypothesis is that the mean change from baseline is equal to zero).|Mean Difference (Net)|-2.353|STANDARD_DEVIATION|0.7124||0.005|TWO_SIDED|95.0|-3.101|-1.606|||Student's t-test||Difference is only calculated in participants who had baseline and week 218 values for n=6|||-1.606|-3.101|0.005
72596117|NCT02117713|144723937|EQUIVALENCE|Student's t-test was used to test if mean change was statistically significant (null hypothesis is that the mean change from baseline is equal to zero).|Mean Difference (Net)|56.0|STANDARD_DEVIATION|119.32||0.2607|TWO_SIDED|95.0|-54.4|166.4|||Student's t-test||Difference is only calculated in participants who had baseline and week 216 values for n=7|||166.4|-54.4|0.2607
72596118|NCT02117713|144723938|EQUIVALENCE|Student's t-test was used to test if mean change was statistically significant (null hypothesis is that the mean change from baseline is equal to zero).|Mean Difference (Net)|-141.6|STANDARD_DEVIATION|216.25||0.134|TWO_SIDED|95.0|-341.6|58.4|||Student's t-test||Difference is only calculated in participants who had baseline and week 216 values for n=7|||58.4|-341.6|0.1340
72596119|NCT02117713|144723939|EQUIVALENCE|Student's t-test was used to test if mean change was statistically significant (null hypothesis is that the mean change from baseline is equal to zero).|Mean Difference (Net)|47.6|STANDARD_DEVIATION|75.68||0.1474|TWO_SIDED|95.0|-22.4|117.6|||Student's t-test||Difference is only calculated in participants who had baseline and week 216 values for n=7|||117.6|-22.4|0.1474
72596120|NCT02117713|144723940|EQUIVALENCE|Student's t-test was used to test if mean change was statistically significant (null hypothesis is that the mean change from baseline is equal to zero).|Mean Difference (Net)|0.0|STANDARD_DEVIATION|0.58||1|TWO_SIDED|95.0|-0.5|0.5|||Student's t-test||Difference is only calculated in participants who had baseline and week 216 values for n=7|||0.5|-0.5|1.00
72596121|NCT02117713|144723941|EQUIVALENCE|Student's t-test used to test if mean change is statistically significant (null hypothesis is that the mean change from baseline is equal to zero).|Mean Difference (Net)|-1.7|STANDARD_DEVIATION|1.38||0.0167|TWO_SIDED|95.0|-3.0|-0.4|||Student's t-test||Difference is only calculated in participants who had baseline and week 216 values for n=7|||-0.4|-3|0.0167
72596122|NCT02117713|144723942|EQUIVALENCE|Student's t-test was used to test if mean change was statistically significant (null hypothesis is that the mean change from baseline is equal to zero).|Mean Difference (Net)|10.9|STANDARD_DEVIATION|245.92||0.9108|TWO_SIDED|95.0|-216.6|238.3|||Student's t-test||Difference is only calculated in participants who had baseline and week 216 values for n=7|||238.3|-216.6|0.9108
72596123|NCT02117713|144723943|EQUIVALENCE|Student's t-test was used to test if mean change was statistically significant(null hypothesis is that the mean change from baseline is equal to zero).|Mean Difference (Net)|0.1207|STANDARD_DEVIATION|1.882||0.1207|TWO_SIDED|95.0|-3.03|0.45|||Student's t-test||Difference is only calculated in participants who had baseline and week 216 values for n=7|||0.45|-3.03|0.1207
72596124|NCT02117713|144723944|EQUIVALENCE|Student's t-test was used to test if mean change was statistically significant (null hypothesis is that the mean change from baseline is equal to zero).|Mean Difference (Net)|-0.943|STANDARD_DEVIATION|1.2488||0.0927|TWO_SIDED|95.0|-2.098|0.212|||Student's t-test||Difference is only calculated in participants who had baseline and week 216 values for n=7|||0.212|-2.098|0.0927
72596125|NCT02028169|144723945|SUPERIORITY||||||<|0.001|||||||Friedman test|||Baseline vs. Month 9||||< 0.001
72596126|NCT02028169|144723946|SUPERIORITY||||||<|0.001|||||||Friedman test|||Baseline vs. Month 9||||< 0.001
72596127|NCT02028169|144723947|SUPERIORITY||||||<|0.001|||||||Friedman test|||Baseline Vs. Month 9||||< 0.001
72596128|NCT02028169|144723948|SUPERIORITY||||||<|0.001|||||||Friedman test|||Baseline vs. Month 9||||< 0.001
72596129|NCT02028169|144723949|SUPERIORITY||||||<|0.001|||||||Friedman test|||Baseline vs. Month 3||||< 0.001
72596130|NCT02028169|144723949|SUPERIORITY||||||<|0.001|||||||Friedman test|||Baseline vs. Month 6||||< 0.001
72596131|NCT02028169|144723949|SUPERIORITY||||||<|0.001|||||||Friedman test|||Baseline vs. Month 9||||< 0.001
72596132|NCT02028169|144723952|SUPERIORITY||||||<|0.001|||||||Friedman test|||Baseline vs. Month 3||||< 0.001
72596133|NCT02028169|144723952|SUPERIORITY||||||<|0.001|||||||Friedman test|||Baseline vs. Month 6||||< 0.001
72596134|NCT02028169|144723952|SUPERIORITY||||||<|0.001|||||||Friedman test|||Baseline vs. Month 9||||< 0.001
72415296|NCT02693665|144341316|SUPERIORITY||Risk Ratio (RR)|1.00743162|||<|0.05|TWO_SIDED|95.0|0.928|1.094||The generalized mixed effect models are taking into account missingness by attrition. There were not missing values for the outcomes or predictors that we used.|Mixed Models Analysis|Model forced age, gender, race, family education, family income under the Federal Poverty level, on/off treatment.||Emotional distress-anxiety analysis at baseline comparing intervention and control.||1.094|0.928|<0.05
72415297|NCT02693665|144341316|SUPERIORITY||Risk Ratio (RR)|1.05037501|||<|0.05|TWO_SIDED|95.0|0.96438584|1.14403138||The generalized mixed effect models are taking into account missingness by attrition. There were not missing values for the outcomes or predictors that we used.|Mixed Models Analysis|Model forced age, gender, race, family education, family income under the Federal Poverty level, on/off treatment.||Emotional distress-anxiety analysis at 3 months post baseline comparing intervention and control. We hypothesized that anxiety would be lower in the intervention group compared to controls.||1.14403138|0.96438584|<0.05
72596135|NCT02028169|144723953|SUPERIORITY||||||<|0.001|||||||Friedman test|||Baseline vs. Month 3||||< 0.001
72415298|NCT02693665|144341316|SUPERIORITY|See earlier comments.|Risk Ratio (RR)|1.01136067|||<|0.05|TWO_SIDED|95.0|0.92887892|1.10116656||See earlier comments.|t-test, 2 sided|See earlier comments.||This is analysis for 6 month outcomes of Emotional-distress - anxiety. See details in 3 month outcomes.||1.10116656|0.92887892|<0.05
72596136|NCT02028169|144723953|SUPERIORITY||||||<|0.001|||||||Friedman test|||Baseline vs. Month 6||||< 0.001
72596137|NCT02028169|144723953|SUPERIORITY||||||<|0.001|||||||Friedman test|||Baseline vs. Month 9||||< 0.001
72596138|NCT02028169|144723954|SUPERIORITY||||||<|0.001|||||||Friedman test|||Baseline vs. Month 9||||< 0.001
72596139|NCT02028169|144723955|SUPERIORITY||||||<|0.001|||||||Friedman test|||Baseline vs. Month 3||||< 0.001
72415299|NCT02693665|144341316|SUPERIORITY||Risk Ratio (RR)|1.14070431|||<|0.05|TWO_SIDED|95.0|1.04444724|1.2458325|||t-test, 2 sided||See earlier comments.|These are the 12 month outcomes for Emotional distress - anxiety. See earlier comments.||1.24583250|1.04444724|<0.05
72596140|NCT02028169|144723955|SUPERIORITY||||||<|0.001|||||||Friedman test|||Baseline vs. Month 6||||< 0.001
72596141|NCT02028169|144723955|SUPERIORITY||||||<|0.001|||||||Friedman test|||Baseline vs. Month 9||||< 0.001
72596142|NCT02028169|144723957|SUPERIORITY||||||<|0.001|||||||Friedman test|||Baseline vs. Month 9||||< 0.001
72596143|NCT02028169|144723959|SUPERIORITY||||||<|0.001|||||||Friedman test|||Baseline vs. Month 3||||< 0.001
72596144|NCT02028169|144723959|SUPERIORITY||||||<|0.001|||||||Friedman test|||Baseline vs. Month 6||||< 0.001
72596145|NCT02028169|144723959|SUPERIORITY||||||<|0.001|||||||Friedman test|||Baseline vs. Month 9||||< 0.001
72596146|NCT02028169|144723960|SUPERIORITY||||||<|0.001|||||||Friedman test|||Baseline vs. Month 3||||< 0.001
72596147|NCT02028169|144723960|SUPERIORITY||||||<|0.001|||||||Friedman test|||Baseline vs. Month 6||||< 0.001
72596148|NCT02028169|144723960|SUPERIORITY||||||<|0.001|||||||Friedman test|||Baseline vs. Month 9||||< 0.001
72596149|NCT02028169|144723961|SUPERIORITY||||||<|0.001|||||||Friedman test|||Baseline vs. Month 3||||< 0.001
72596150|NCT02028169|144723961|SUPERIORITY||||||<|0.001|||||||Friedman test|||Baseline vs. Month 6||||< 0.001
72596151|NCT02028169|144723961|SUPERIORITY||||||<|0.001|||||||Friedman test|||Baseline vs. Month 9||||< 0.001
72596152|NCT02028169|144723962|SUPERIORITY||||||<|0.001|||||||Friedman test|||Baseline vs. Month 3||||< 0.001
72596153|NCT02028169|144723962|SUPERIORITY||||||<|0.001|||||||Friedman test|||Baseline vs. Month 6||||< 0.001
72596154|NCT02028169|144723962|SUPERIORITY||||||<|0.001|||||||Friedman test|||Baseline vs. Month 9||||< 0.001
72596155|NCT02028169|144723963|SUPERIORITY||||||<|0.001|||||||Friedman test|||Baseline vs. Month 3||||< 0.001
72596156|NCT02028169|144723963|SUPERIORITY||||||<|0.001|||||||Friedman test|||Baseline vs. Month 6||||< 0.001
72596157|NCT02028169|144723963|SUPERIORITY||||||<|0.001|||||||Friedman test|||Baseline vs. Month 9||||< 0.001
72596158|NCT03646305|144723982|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||<|0.001|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at significance level of alpha .05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental,control) × 2(Activity: singing,verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA was used to measure main effect of time. Null: Across the sample, believability of thought were equivalent across time||||<0.001
72596159|NCT03646305|144723982|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||<|0.001|||||||t-test, 2 sided|||A paired sample t-test was conducted to measure differences in believability of thought from baseline to post-intervention. Null hypothesis: there would be no significant difference in believability of thought from baseline to post-intervention||||<0.001
72596160|NCT03646305|144723982|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||<|0.001|||||||t-test, 2 sided|||A paired sample t-test was conducted to measure differences from post-intervention to follow-up. Null hypothesis: there would be no significant differences in believability of thought from post-intervention to follow-up.||||<0.001
72596161|NCT03646305|144723982|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at significance level of alpha .05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA was used to analyze main effect of Intervention. Null: On average, the experimental conditions and control conditions would have equal believability scores||||>0.05
72596162|NCT03646305|144723982|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at significance level of alpha .05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA was used to analyze main effect of Activity. Null: On average, singing and verbal repetition would have equal believability scores||||>0.05
72415300|NCT02693665|144341316|SUPERIORITY||Risk Ratio (RR)|0.98078271|||<|0.05|TWO_SIDED|95.0|0.89845609|1.07065301|||t-test, 2 sided|||This analysis is for the outcome Emotional distress - depressive symptoms. We hypothesized that adolescent in the intervention would have lower depressive symptoms compared to controls at 3, 6, and 12 month outcomes. The following are the baseline comparisons between control and intervention which were controlled for in the 3, 6, and 12 month analysis of outcomes.||1.07065301|0.89845609|<0.05
72415301|NCT02693665|144341316|SUPERIORITY||Risk Ratio (RR)|1.04007715|||<|0.05|TWO_SIDED|95.0|0.94970156|1.13905306|||t-test, 2 sided|||The results here are for the outcome variable Emotional Distress - Depressive symptoms at 3 month outcomes. We hypothesized that adolescents randomized to the intervention would have lower depressive symptoms than controls.||1.13905306|0.94970156|<0.05
72596163|NCT03646305|144723982|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||Twenty-eight participants per condition (N=112) would provide sufficient power (0.8) to detect moderate effect size (.25) at significance level of alpha .05 in a mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post-intervention, follow-up) mixed ANOVA was used to analyze Intervention x Activity interaction. Null: On average, all four conditions were equivalent in believability scores||||>0.05
72596164|NCT03646305|144723982|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at a significance level of alpha .05 in a mixed ANOVA according to a power analysis using GPower 3.1. A 2 (Intervention: experimental, control) × 3 (Time: baseline, post-intervention, follow-up) mixed ANOVA was used to measure Time x Intervention interactions. Null: experimental and control conditions have equivalent believability scores across time.||||>0.05
72596165|NCT03646305|144723982|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect moderate effect size (.25) at significance level of alpha.05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA was used to analyze Time x Activity interaction. Null: Across time, there would be no difference between singing and verbal repetition on believability scores||||>0.05
72415302|NCT02693665|144341316|SUPERIORITY||Risk Ratio (RR)|1.07347088|||<|0.05|TWO_SIDED|95.0|0.9806271|1.17510491|||t-test, 2 sided|||We hypothesize that Emotional Distress - Depressive symptoms would be lower in intervention adolescents compared to controls at 6 months post intervention.||1.17510491|0.98062710|<0.05
72415303|NCT02693665|144341316|SUPERIORITY||Risk Ratio (RR)|1.11582434|||<|0.05|TWO_SIDED|95.0|1.01653156|1.22481585|||t-test, 2 sided|||We hypothesized that adolescents randomized to the intervention would have lower scores on Emotional Distress - Depressive symptoms compared to controls at 12 months post baseline.||1.22481585|1.01653156|<0.05
72415304|NCT02693665|144341316|SUPERIORITY||Risk Ratio, log|0.98803061|||<|0.05|TWO_SIDED|95.0|0.89065531|1.09605195|||t-test, 2 sided|||We hypothesized that adolescents randomized to the intervention would have no differences in fatigue at baseline if randomization was successful. In this analysis we examine the baseline results.||1.09605195|0.89065531|<0.05
72596166|NCT03646305|144723982|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect moderate effect size (.25) at significance level of alpha.05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA was used to analyze Time x Intervention x Activity interaction. Null: Across time, there would be no significant difference between 4 conditions on believability||||>0.05
72596167|NCT03646305|144723983|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||<|0.001|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at significance level of alpha .05 in a mixed ANOVA according to a power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA was used to measure main effect of time. Null: Across the sample, appraisal of target thought were equivalent across time.||||<0.001
72596168|NCT03646305|144723983|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||=|0.005|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at a significance level of alpha .05 in a mixed ANOVA according to a power analysis using GPower 3.1. A 2 (Intervention: experimental, control) × 3 (Time: baseline, post-intervention, follow-up) mixed ANOVA was used to measure Time x Intervention interactions. Null: experimental and control conditions are equivalent across time.||||=0.005
72596169|NCT03646305|144723983|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||=|0.002|||||||t-test, 2 sided|||Paired sample t-tests was conducted to measure differences in negativity from baseline to post-intervention. Null hypothesis: the control conditions would have no significant difference in negativity from baseline to post-intervention||||=0.002
72415305|NCT02693665|144341316|SUPERIORITY||Risk Ratio (RR)|1.13509797|||<|0.05|TWO_SIDED|95.0|1.01959639|1.26368376|||t-test, 2 sided|||We hypothesized that adolescents randomized to the intervention arm would report less Fatigue at 3 months outcome compared to controls.||1.26368376|1.01959639|<0.05
72415306|NCT02693665|144341316|SUPERIORITY||Risk Ratio (RR)|1.04944737|||<|0.05|TWO_SIDED|95.0|0.94281417|1.16814089|||t-test, 2 sided|||We hypothesized that adolescents randomized to the intervention would report less Fatigue at 6 months post baseline compared to control adolescents.||1.16814089|0.94281417|<0.05
72415307|NCT02693665|144341316|SUPERIORITY||Risk Ratio (RR)|1.11042568|||<|0.05|TWO_SIDED|95.0|0.99383841|1.24068981|||t-test, 2 sided|||We hypothesized that intervention adolescents would report less Fatigue than controls at 12 months post baseline.||1.24068981|0.99383841|<0.05
72415308|NCT02693665|144341316|SUPERIORITY||Risk Ratio (RR)|0.9683347|||<|0.05|TWO_SIDED|95.0|0.88658183|1.05762611|||t-test, 2 sided|||We hypothesized that there would be no differences at baseline between intervention and control adolescents with respect to Pain Interference.||1.05762611|0.88658183|<0.05
72415309|NCT02693665|144341316|SUPERIORITY||Risk Ratio (RR)|1.04450374|||<|0.05|TWO_SIDED|95.0|0.95307464|1.1447037|||t-test, 2 sided|||We hypothesized that adolescents randomized to the intervention compared to controls would report less Pain Interference at 3 months post baseline.||1.14470370|0.95307464|<0.05
72596170|NCT03646305|144723983|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||<|0.001|||||||t-test, 2 sided|||Paired sample t-tests was conducted to measure differences in negativity from post-intervention to follow-up. Null hypothesis: the control conditions would have no significant difference in negativity from post-intervention to follow-up.||||<0.001
72415310|NCT02693665|144341316|SUPERIORITY||Risk Ratio (RR)|1.07182133|||<|0.05|TWO_SIDED|95.0|0.97835451|1.17421748|||t-test, 2 sided|||We hypothesized that adolescents randomized to the intervention compared to controls would report less Pain Interference at 6 months post baseline.||1.17421748|0.97835451|<0.05
72415311|NCT02693665|144341316|SUPERIORITY||Risk Ratio, log|1.09964781|||<|0.05|TWO_SIDED|95.0|1.00051223|1.20860622|||t-test, 2 sided|||We hypothesized that at 12 month outcome adolescents randomized to the intervention would report less Pain Interference compared to control adolescents.||1.20860622|1.00051223|<0.05
72415312|NCT02693665|144341317|SUPERIORITY||Mean ratio|0.98|||<|0.05|TWO_SIDED|95.0|0.88|1.09|||Mixed Models Analysis|||Meaning and Peace Subscale at 3 months post intervention||1.09|0.88|<0.05
72415313|NCT02693665|144341317|SUPERIORITY||Mean ratio|0.97|||<|0.05|TWO_SIDED|95.0|0.88|1.08|||Mixed Models Analysis|||Meaning and Peace subscale at 6 months post intervention||1.08|0.88|<0.05
72596171|NCT03646305|144723983|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.025|||||||t-test, 2 sided|||A paired sample t-test was conducted to measure differences in negativity from baseline to post-intervention. Null hypothesis: there would be no significant difference in negativity scores from baseline to post-intervention in the experimental conditions||||>0.025
72596172|NCT03646305|144723983|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.025|||||||t-test, 2 sided|||Paired sample t-tests was conducted to measure differences in negativity from post-intervention to follow-up. Null hypothesis: the experimental conditions would have no significant difference in negativity scores from post-intervention to follow-up.||||>0.025
72596173|NCT03646305|144723983|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect moderate effect size (.25) at significance alpha .05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post-intervention, follow-up) mixed ANOVA was used to analyze main effect of Intervention. Null: On average, the experimental conditions and control conditions would have equal negativity scores||||>0.05
72415314|NCT02693665|144341317|SUPERIORITY||Mean ratio|0.92|||<|0.05|TWO_SIDED|95.0|0.82|1.02|||Mixed Models Analysis|||Meaning and Peace subscale at 12 months post intervention||1.02|0.82|<0.05
72415315|NCT02693665|144341317|SUPERIORITY||Mean ratio|0.92|||<|0.05|TWO_SIDED|95.0|0.73|1.16|||Mixed Models Analysis|||Faith subscale score at 3 months post intervention||1.16|0.73|<0.05
72415316|NCT02693665|144341317|SUPERIORITY||Mean ratio|0.96|||<|0.05|TWO_SIDED|95.0|0.76|1.21|||Mixed Models Analysis|||Faith subscale at 6 months post intervention||1.21|0.76|<0.05
72415317|NCT02693665|144341317|SUPERIORITY||Mean ratio|0.92|||<|0.05|TWO_SIDED|95.0|0.72|1.17|||Mixed Models Analysis|||Faith subscale scores at 12 months post intervention||1.17|0.72|<0.05
72596174|NCT03646305|144723983|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at significance level of alpha .05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA was used to analyze main effect of Activity. Null: On average, singing and verbal repetition would have equal negativity scores||||>0.05
72596175|NCT03646305|144723983|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||Twenty-eight participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at significance level of alpha .05 in a mixed ANOVA according to a power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post-intervention, follow-up) mixed ANOVA was used to analyze Intervention x Activity interaction. Null: On average, all four conditions were equivalent in negativity scores||||>0.05
72596176|NCT03646305|144723983|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect moderate effect size (.25) at significance level of alpha.05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA was used to analyze Time x Activity interaction. Null: Across time, there would be no difference between singing and verbal repetition on negativity scores||||>0.05
72415318|NCT02693665|144341318|SUPERIORITY||Mean Difference (Final Values)|-0.14|||<|0.05|TWO_SIDED|95.0|-0.42|0.15|||GEE model|||Caregiver Strain subscale at 3 months post-intervention comparing intervention to TAU, controlling for baseline levels.||0.15|-0.42|<0.05
72415319|NCT02693665|144341318|SUPERIORITY||Mean Difference (Final Values)|0.19|||<|0.05|TWO_SIDED|95.0|0.02|0.36|||GEE model|||Positive Caregiving Appraisal subscale at 3 months post-intervention comparing intervention to TAU, controlling for baseline levels.||0.36|0.02|<0.05
72415320|NCT02693665|144341318|SUPERIORITY||Mean Difference (Final Values)|-0.01|||<|0.05|TWO_SIDED|95.0|-0.35|0.32|||GEE model|||Caregiver Distress subscale at 3 months post-intervention comparing intervention to TAU, controlling for baseline levels.||0.32|-0.35|<0.05
72415321|NCT02693665|144341318|SUPERIORITY||Mean Difference (Final Values)|0.16|||<|0.05|TWO_SIDED|95.0|-0.07|0.38|||GEE model|||Family Well-Being subscale at 3 months post-intervention, comparing intervention to TAU, controlling for baseline levels.||0.38|-0.07|<0.05
72415322|NCT02693665|144341320|SUPERIORITY||Slope|0.44|STANDARD_ERROR_OF_MEAN|0.59||0.47|TWO_SIDED||||||Regression, Linear|Intervention effect for quality of adolescent communication score controlling for age, gender, race, income and on active treatment.|It is the standard error of the slope, but this was not an option.|Quality of communication analysis for adolescents||||0.47
72415323|NCT02693665|144341320|SUPERIORITY||Slope|1.15|STANDARD_ERROR_OF_MEAN|0.41|<|0.01|TWO_SIDED||||||Regression, Linear|Testing intervention effect for family member quality of communication score controlling for age, gender, race, income nd on active treatment.|This is standard error of the slope.|Quality of communication analysis for family member.||||<0.01
72415324|NCT02693665|144341326|SUPERIORITY||Mean Difference (Net)|0.72|STANDARD_ERROR_OF_MEAN|0.71|<|0.05|TWO_SIDED||||||t-test, 2 sided|||Adolescent positive score comparing intervention with TAU.||||<0.05
72415325|NCT02693665|144341326|SUPERIORITY||Mean Difference (Final Values)|0.93|STANDARD_ERROR_OF_MEAN|0.73|<|0.05|TWO_SIDED||||||t-test, 2 sided|||Adolescent negative worded score comparing intervention to TAU.||||<0.05
72415326|NCT02693665|144341326|SUPERIORITY||Mean Difference (Final Values)|2.98|STANDARD_ERROR_OF_MEAN|0.74|<|0.05|TWO_SIDED||||||t-test, 2 sided|||Family member positively worded score comparing intervention with treatment as usual.||||<0.05
72415327|NCT02693665|144341326|SUPERIORITY||Mean Difference (Final Values)|-1.15|STANDARD_ERROR_OF_MEAN|0.81|<|0.05|TWO_SIDED||||||t-test, 2 sided|||Family member negative worded score comparing intervention to TAU.||||<0.05
72415328|NCT00710424|144341335|SUPERIORITY_OR_OTHER_LEGACY||estimated treatment effect|-0.12||||0.634|TWO_SIDED|95.0|-0.6|0.36|||ANCOVA||A negative difference in treatment effect indicates an improvement in pain in favour of Sativex.|The model used for the analysis of the end of study value was an analysis of covariance (ANCOVA) with baseline value as a covariate and treatment group and centre group as main effect. The test was performed at the 10% significance level as a possible indicator of an interactive effect. The null hypothesis was one of no difference between treatments.||0.36|-0.60|0.634
72415329|NCT00710424|144341336|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|0.37|STANDARD_ERROR_OF_MEAN|2.153||0.865|TWO_SIDED|95.0|-3.87|4.61|||ANCOVA|||The change from baseline in mean neuropathic pain scale scale score at the end of treatment was to be compared between treatment groups using ANCOVA. The model was to include treatment and centre group as factors and baseline mean usage as a covariate.||4.61|-3.87|0.865
72415330|NCT00710424|144341337|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-0.45||||0.139|TWO_SIDED|95.0|-1.04|0.15|||ANCOVA|||The change from baseline in mean sleep quality numerical rating scale score at the end of treatment was compared between treatment groups using ANCOVA. The model included treatment and centre group as factors and baseline mean usage as a covariate.||0.15|-1.04|0.139
72415331|NCT00710424|144341338|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.301||||0.219|TWO_SIDED|95.0|0.855|1.981|||Regression, Logistic|||In the analysis of Subject Global Impression of Change, the two treatment groups were compared using ordinal logistic regression and the proportional odds model. The model incorporated centre group as a factor.||1.981|0.855|0.219
72415332|NCT00710424|144341339|SUPERIORITY_OR_OTHER_LEGACY||estimated mean treatment difference|-0.05||||0.841|TWO_SIDED|95.0|-0.51|0.42|||ANCOVA|||The change from baseline in mean brief pain inventory (short form) composite score at the end of treatment was compared between treatment groups using ANCOVA. The model included treatment and centre group as factors and baseline mean usage as a covariate.||0.42|-0.51|0.841
72415333|NCT00710424|144341340|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.021||0.523|TWO_SIDED|95.0|-0.06|0.03|||ANCOVA|||The change from baseline in weighted health state index score at the end of treatment was compared between treatment groups using ANCOVA. The model included treatment and centre group as factors and baseline symptom score as a covariate.||0.03|-0.06|0.523
72415334|NCT00710424|144341341|SUPERIORITY_OR_OTHER_LEGACY||estimated mean treatment difference|-0.17||||0.41|TWO_SIDED|95.0|-0.59|0.24|||ANCOVA|||The model used for the analysis of the end of study value was ANCOVA with baseline value as a covariate and treatment group and centre group as main effect. The test was performed at the 10% significance level as a possible indicator of an interactive effect. The null hypothesis was one of no difference between treatments. A negative difference in adjusted means indicates an improvement in favour of Sativex.||0.24|-0.59|0.410
72415335|NCT00710424|144341344|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.857||||0.521|TWO_SIDED|95.0|0.537|1.37|||Regression, Logistic|||The numbers of responders were to be analysed using the difference in proportions and the odds ratio comparing the treatment groups with the provision of 95% CIs for the difference and odds ratio.||1.370|0.537|0.521
72415336|NCT01962493|144341345|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.155||0.1313|TWO_SIDED|95.0|-0.51|0.1||Analysis based on square root transformation. Results back transformed for interpretation.|ANCOVA|Results were obtained from ANCOVA model with Site, Treatment, Treatment X Site, Smoking Status as fixed effects and baseline MLSI as a covariate.|Difference is first named treatment minus second named treatment. A negative difference favors the first named treatment|Null hypothesis stated that there was no difference between treatment groups||0.10|-0.51|0.1313
72415337|NCT04414696|144341360|SUPERIORITY||Mean Difference (Final Values)|-0.9|||||TWO_SIDED|95.0|-3.3|1.5|||||Multivariable linear regression|||1.5|-3.3|
72415338|NCT04414696|144341361|SUPERIORITY||Mean Difference (Final Values)|-4.5|||||TWO_SIDED|95.0|-23.5|14.5|||||Multivariable linear regression|||14.5|-23.5|
72415339|NCT04414696|144341362|SUPERIORITY||Mean Difference (Final Values)|3.8|||||TWO_SIDED|95.0|-1.9|9.5||||||||9.5|-1.9|
72415340|NCT04414696|144341363|SUPERIORITY||Mean Difference (Final Values)|1.3|||||TWO_SIDED|95.0|-18.9|21.5|||||Multivariable linear regression|||21.5|-18.9|
72415341|NCT04414696|144341364|SUPERIORITY||Mean Difference (Final Values)|-1.3|||||TWO_SIDED|95.0|-3.7|1.1|||||Multivariable linear regression|||1.1|-3.7|
72415342|NCT04414696|144341365|SUPERIORITY||Mean Difference (Final Values)|-1.8|||||TWO_SIDED|95.0|-7.7|4.2|||||Multivariable linear regression|||4.2|-7.7|
72415343|NCT04414696|144341366|SUPERIORITY||Mean Difference (Final Values)|0.5|||||TWO_SIDED|95.0|-1.2|2.1|||||Multivariable linear regression|||2.1|-1.2|
72415344|NCT04414696|144341367|SUPERIORITY||Mean Difference (Final Values)|0.0|||||TWO_SIDED|95.0|-1.0|1.1|||||Multivariable linear regression|||1.1|-1|
72415345|NCT04414696|144341368|SUPERIORITY||Mean Difference (Final Values)|-1.1|||||TWO_SIDED|95.0|-3.4|1.2|||||Multivariable linear regression|||1.2|-3.4|
72415346|NCT04414696|144341369|SUPERIORITY||Mean Difference (Final Values)|-1.8|||||TWO_SIDED|95.0|-4.9|1.3|||||Multivariable linear regression|||1.3|-4.9|
72415347|NCT02621931|144341378|SUPERIORITY||LSM difference from placebo|-1.8|STANDARD_ERROR_OF_MEAN|0.33|<|0.0001|TWO_SIDED|95.0|-2.46|-1.15||0.05 level of significance|Wilcoxon (Mann-Whitney)|||Due to the deviation from the normal distribution assumption of the data, the primary analysis was conducted using the Wilcoxon rank-sum test as outlined in the statistical analysis plan (SAP).||-1.15|-2.46|<0.0001
72415348|NCT02621931|144341378|SUPERIORITY||LSM difference from placebo|-2.1|STANDARD_ERROR_OF_MEAN|0.33|<|0.0001|TWO_SIDED|95.0|-2.76|-1.45||0.05 level of significance|Wilcoxon (Mann-Whitney)|||Due to the deviation from the normal distribution assumption of the data, the primary analysis was conducted using the Wilcoxon rank-sum test as outlined in the SAP.||-1.45|-2.76|<0.0001
72415349|NCT02621931|144341380|SUPERIORITY||LSM difference from placebo|-1.7|STANDARD_ERROR_OF_MEAN|0.39|<|0.0001|TWO_SIDED|95.0|-2.48|-0.97||0.05 level of significance|ANCOVA|||||-0.97|-2.48|<0.0001
72415350|NCT02621931|144341380|SUPERIORITY||LSM difference from placebo|-1.8|STANDARD_ERROR_OF_MEAN|0.39|<|0.0001|TWO_SIDED|95.0|-2.61|-1.09||0.05 level of significance|ANCOVA|||||-1.09|-2.61|<0.0001
72415351|NCT02621931|144341381|SUPERIORITY||||||<|0.0001||||||0.05 level of significance. P-value based on Cochran-Mantel-Haenszel test stratified by baseline preventive medication use.|Cochran-Mantel-Haenszel|||Month 1: Active 675/placebo/placebo to Placebo||||<0.0001
72415352|NCT02621931|144341381|SUPERIORITY||||||<|0.0001||||||0.05 level of significance. P-value based on Cochran-Mantel-Haenszel test stratified by baseline preventive medication use.|Cochran-Mantel-Haenszel|||Month 1: Active 675/225/225 to Placebo||||<0.0001
72415353|NCT02621931|144341381|SUPERIORITY||||||<|0.0001||||||0.05 level of significance. P-value based on Cochran-Mantel-Haenszel test stratified by baseline preventive medication use.|Cochran-Mantel-Haenszel|||Month 2||||<0.0001
72415354|NCT02621931|144341381|SUPERIORITY||||||<|0.0001||||||0.05 level of significance. P-value based on Cochran-Mantel-Haenszel test stratified by baseline preventive medication use.|Cochran-Mantel-Haenszel|||Month 2||||<0.0001
72415355|NCT02621931|144341381|SUPERIORITY||||||<|0.0001||||||0.05 level of significance. P-value based on Cochran-Mantel-Haenszel test stratified by baseline preventive medication use.|Cochran-Mantel-Haenszel|||Month 3||||<0.0001
72415356|NCT02621931|144341381|SUPERIORITY||||||<|0.0001||||||0.05 level of significance. P-value based on Cochran-Mantel-Haenszel test stratified by baseline preventive medication use.|Cochran-Mantel-Haenszel|||Month 3||||<0.0001
72415357|NCT02621931|144341381|SUPERIORITY||||||<|0.0001||||||0.05 level of significance. P-value based on Cochran-Mantel-Haenszel test stratified by baseline preventive medication use.|Cochran-Mantel-Haenszel|||Overall||||<0.0001
72415358|NCT02621931|144341381|SUPERIORITY||||||<|0.0001||||||0.05 level of significance. P-value based on Cochran-Mantel-Haenszel test stratified by baseline preventive medication use.|Cochran-Mantel-Haenszel|||Overall||||<0.0001
72415359|NCT02621931|144341382|SUPERIORITY||||||<|0.0001||||||0.05 level of significance|Wilcoxon (Mann-Whitney)|||Due to the deviation from the normal distribution assumption of the data, the primary analysis was conducted using the Wilcoxon rank-sum test as outlined in the SAP.||||<0.0001
72415360|NCT02621931|144341382|SUPERIORITY||||||<|0.0001||||||0.05 level of significance|Wilcoxon (Mann-Whitney)|||Due to the deviation from the normal distribution assumption of the data, the primary analysis was conducted using the Wilcoxon rank-sum test as outlined in the SAP.||||<0.0001
72415361|NCT02621931|144341383|SUPERIORITY||LSM difference from placebo|-2.3|STANDARD_ERROR_OF_MEAN|0.31|<|0.0001|TWO_SIDED|95.0|-2.95|-1.73||0.05 level of significance|ANCOVA|||||-1.73|-2.95|<0.0001
72415362|NCT02621931|144341384|SUPERIORITY||||||<|0.0001||||||0.05 level of significance|Wilcoxon (Mann-Whitney)|||Due to the deviation from the normal distribution assumption of the data, the primary analysis was conducted using the Wilcoxon rank-sum test as outlined in the SAP.||||<0.0001
72415363|NCT02621931|144341384|SUPERIORITY||||||<|0.0001||||||0.05 level of significance|Wilcoxon (Mann-Whitney)|||Due to the deviation from the normal distribution assumption of the data, the primary analysis was conducted using the Wilcoxon rank-sum test as outlined in the SAP.||||<0.0001
72415364|NCT02621931|144341385|SUPERIORITY|||||||0.0004||||||0.05 level of significance|Wilcoxon (Mann-Whitney)|||Due to the deviation from the normal distribution assumption of the data, the primary analysis was conducted using the Wilcoxon rank-sum test as outlined in the SAP.||||0.0004
72415365|NCT02621931|144341385|SUPERIORITY||||||<|0.0001||||||0.05 level of significance|Wilcoxon (Mann-Whitney)|||Due to the deviation from the normal distribution assumption of the data, the primary analysis was conducted using the Wilcoxon rank-sum test as outlined in the SAP.||||<0.0001
72596177|NCT03646305|144723983|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect moderate effect size (.25) at significance level of alpha.05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA was used to analyze Time x Intervention x Activity interaction. Null: Across time, there would be no difference between four conditions on negativity scores||||>0.05
72596178|NCT03646305|144723984|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||<|0.001|||||||ANOVA|||Twenty-eight participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at p\< .05 in a mixed ANOVA according to a power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post-intervention, follow-up) mixed ANOVA was used to measure main effect of time. Null: Across the sample, levels of discomfort were equivalent across time.||||<0.001
72415366|NCT02811861|144341393|SUPERIORITY||Stratified Hazard Ratio|0.65|||<|0.0001|TWO_SIDED|95.0|0.53|0.8|||Stratified Log-rank Test|Hazard ratio is based on a Cox Proportional Hazards Model including treatment group as a factor.||||0.80|0.53|<0.0001
72596179|NCT03646305|144723984|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||<|0.001|||||||t-test, 2 sided|||Paired sample t-tests was conducted to measure differences in levels of discomfort from baseline to post-intervention. Null hypothesis: there would have no significant differences in discomfort levels from baseline to post-intervention across samples||||<0.001
72596180|NCT03646305|144723984|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||<|0.001|||||||t-test, 2 sided|||Paired sample t-tests was conducted to measure differences in levels of discomfort from post-intervention to follow-up. Null hypothesis: there would be no significant differences in discomfort levels from post-intervention to follow-up across samples||||<0.001
72596181|NCT03646305|144723984|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at significance level of alpha .05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA was used to analyze main effect of Intervention. Null: On average, the experimental conditions and control conditions would have equal levels of discomfort||||>0.05
72596182|NCT03646305|144723984|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at significance level of alpha .05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA was used to analyze main effect of Activity. Null: On average, singing and verbal repetition would have equal levels of discomfort||||>0.05
72596183|NCT03646305|144723984|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at significance level of alpha .05 in a mixed ANOVA according to a power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post-intervention, follow-up) mixed ANOVA was used to analyze Intervention x Activity interaction. Null: On average, all four conditions were equivalent in levels of discomfort||||>0.05
72596184|NCT03646305|144723984|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at a significance level of alpha .05 in a mixed ANOVA according to a power analysis using GPower 3.1. A 2 (Intervention: experimental, control) × 3 (Time: baseline, post-intervention, follow-up) mixed ANOVA was used to measure Time x Intervention interactions. Null: experimental and control conditions are equivalent in levels of discomfort across time||||>0.05
72596185|NCT03646305|144723984|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect moderate effect size (.25) at significance level of alpha.05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA was used to analyze Time x Activity interaction. Null: Across time, there would be no difference between singing and verbal repetition on levels of discomfort||||>0.05
72596186|NCT03646305|144723984|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect moderate effect size (.25) at significance level of alpha.05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA used to analyze Time x Intervention x Activity interaction. Null: Across time, there would be no significant difference between 4 conditions on discomfort levels||||>0.05
72596187|NCT03646305|144723985|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||<|0.001|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at significance level of alpha .05 in a mixed ANOVA according to a power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA was used to measure main effect of time. Null: Across the sample, willingness to engage with target thought were equivalent across time||||<0.001
72596188|NCT03646305|144723985|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||<|0.001|||||||t-test, 2 sided|||Paired sample t-tests was conducted to measure differences in willingness to engage with target thought from baseline to post-intervention. Null hypothesis: there would be no difference in willingness scores from baseline to post-intervention||||<0.001
72596189|NCT03646305|144723985|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||=|0.053|||||||t-test, 2 sided|||Paired sample t-tests was conducted to measure differences in willingness to engage with target thought from post-intervention to follow-up. Null hypothesis: there would be no significant difference in willingness scores from post-intervention to follow-up.||||=0.053
72596190|NCT03646305|144723985|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at significance level of alpha .05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA was used to analyze main effect of Intervention. Null: On average, the experimental conditions and control conditions would have equal willingness scores||||>0.05
72596191|NCT03646305|144723985|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect moderate effect size (.25) at significance level of alpha .05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA was used to analyze main effect of Activity. Null: On average, singing and verbal repetition would result in equal willingness to engage with the target thought||||>0.05
72596192|NCT03646305|144723985|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||Twenty-eight participants per condition (N=112) would provide sufficient power (0.8) to detect moderate effect size (.25) at significance level of alpha .05 in a mixed ANOVA according to a power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post-intervention, follow-up) mixed ANOVA was used to analyze Intervention x Activity interaction. Null: On average, all 4 conditions were equivalent in willingness to engage||||>0.05
72596193|NCT03646305|144723985|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at a significance level of alpha .05 in a mixed ANOVA according to a power analysis using GPower 3.1. A 2 (Intervention: experimental, control) × 3 (Time: baseline, post-intervention, follow-up) mixed ANOVA was used to measure Time x Intervention interactions. Null: experimental and control conditions are equivalent in willingness to engage with the target thought across time.||||>0.05
72596194|NCT03646305|144723985|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect moderate effect size (.25) at significance level of alpha.05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA was used to analyze Time x Activity interaction. Null: Across time, there would be no difference between singing and verbal repetition on willingness to engage||||>0.05
72596195|NCT03646305|144723985|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect moderate effect size (.25) at significance level of alpha.05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA was used to analyze Time x Intervention x Activity interaction. Null: Across time, there would be no difference between 4 conditions on willingness to engage||||>0.05
72596196|NCT03646305|144723986|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||<|0.01|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at significance level of alpha .05 in a mixed ANOVA according to a power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA was used to measure main effect of time. Null: Across the sample, avoidance of target thought were equivalent across time||||<0.01
72596197|NCT03646305|144723986|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||t-test, 2 sided|||Paired sample t-tests was conducted to measure differences in avoidance of target thought from baseline to post-intervention. Null hypothesis: there would be no significant differences in avoidance from baseline to post-intervention||||>0.05
72596198|NCT03646305|144723986|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress|||||<|0.05|||||||t-test, 2 sided|||Paired sample t-tests was conducted to measure differences in avoidance of target thought from post-intervention to follow-up. Null hypothesis: there would be no significant differences in avoidance from post-intervention to follow-up.||||<0.05
72596199|NCT03646305|144723986|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at significance level of alpha .05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA used to analyze main effect of Intervention. Null: On average, the experimental conditions and control conditions would show equal avoidance of target thought||||>0.05
72596200|NCT03646305|144723986|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at significance level of alpha .05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA was used to analyze main effect of Activity. Null: On average, singing and verbal repetition would result in equal avoidance of target thought||||>0.05
72596201|NCT03646305|144723986|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at significance level of alpha .05 in a mixed ANOVA according to a power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post-intervention, follow-up) mixed ANOVA was used to analyze Intervention x Activity interaction. Null: On average, all 4 conditions were equivalent in avoidance of target thought||||>0.05
72596202|NCT03646305|144723986|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at a significance level of alpha .05 in a mixed ANOVA according to a power analysis using GPower 3.1. A 2 (Intervention: experimental, control) × 3 (Time: baseline, post-intervention, follow-up) mixed ANOVA was used to measure Time x Intervention interactions. Null: experimental and control conditions are equivalent in avoidance of target thought across time.||||>0.05
72596203|NCT03646305|144723986|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect moderate effect size (.25) at significance level of alpha.05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA used to analyze Time x Activity interaction. Null: Across time, there would be no difference between singing and verbal repetition on avoidance of target thought||||>0.05
72596204|NCT03646305|144723986|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect moderate effect size (.25) at significance level of alpha.05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA used to analyze Time x Intervention x Activity interaction. Null: Across time, there would be no difference between 4 conditions on avoidance of target thought||||>0.05
72596205|NCT03646305|144723987|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at significance level of alpha .05 in a mixed ANOVA according to a power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA was used to measure main effect of time. Null: Across the sample, cognitive delusion were equivalent across time||||>0.05
72596206|NCT03646305|144723987|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect moderate effect size (.25) at significance level of alpha .05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA used to analyze main effect of Intervention. Null: On average, the experimental conditions and control conditions would have equal levels of cognitive defusion||||>0.05
72596207|NCT03646305|144723987|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at significance level of alpha .05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA was used to analyze main effect of Activity. Null: On average, singing and verbal repetition would have equal levels of cognitive defusion||||>0.05
72596208|NCT03646305|144723987|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at significance level of alpha .05 in a mixed ANOVA according to a power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post-intervention, follow-up) mixed ANOVA used to analyze Intervention x Activity interaction. Null: On average, all four conditions were equivalent in levels of cognitive defusion||||>0.05
72596209|NCT03646305|144723987|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at a significance level of alpha .05 in a mixed ANOVA according to a power analysis using GPower 3.1. A 2 (Intervention: experimental, control) × 3 (Time: baseline, post-intervention, follow-up) mixed ANOVA was used to measure Time x Intervention interactions. Null: experimental and control conditions are equivalent in levels of cognitive defusion across time.||||>0.05
72596210|NCT03646305|144723987|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect moderate effect size (.25) at significance alpha level .05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA used to analyze Time x Activity interaction. Null: Across time, there would be no difference between singing and verbal repetition on levels of cognitive defusion||||>0.05
72596211|NCT03646305|144723987|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect moderate effect size (.25) at significance alpha level .05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA used to analyze Time x Intervention x Activity interaction. Null: Across time, there would be no difference between four conditions on levels of cognitive defusion||||>0.05
72596212|NCT03646305|144723988|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||<|0.001|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at significance level of alpha .05 in a mixed ANOVA according to a power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA was used to measure main effect of time. Null: Across the sample, weight dissatisfaction were equivalent across time.||||<0.001
72596213|NCT03646305|144723988|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||<|0.001|||||||t-test, 2 sided|||Paired sample t-tests was conducted to measure differences in weight dissatisfaction from baseline to post-intervention. Null hypothesis: there would be no significant differences in weight dissatisfaction from baseline to post-intervention||||<0.001
72415367|NCT02811861|144341393|SUPERIORITY||Stratified Hazard Ratio|0.39|||<|0.0001|TWO_SIDED|95.0|0.32|0.49|||Stratified Log-rank Test|Hazard ratio is based on a Cox Proportional Hazards Model including treatment group as a factor.||||0.49|0.32|<0.0001
72596214|NCT03646305|144723988|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||<|0.05|||||||t-test, 2 sided|||A paired sample t-test was conducted to measure differences in weight dissatisfaction from post-intervention to follow-up. Null: there would be no differences in weight dissatisfaction from post-intervention to follow-up||||<0.05
72596215|NCT03646305|144723988|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at significance level of alpha .05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA was used to analyze main effect of Intervention. Null: On average, the experimental conditions and control conditions would have equal weight dissatisfaction||||>0.05
72596216|NCT03646305|144723988|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at significance level of alpha .05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA was used to analyze main effect of Activity. Null: On average, singing and verbal repetition would have equal weight dissatisfaction scores||||>0.05
72596217|NCT03646305|144723988|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||Twenty-eight participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at significance level of alpha .05 in a mixed ANOVA according to a power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post-intervention, follow-up) mixed ANOVA used to analyze Intervention x Activity interaction. Null: On average, all 4 conditions were equivalent in weight dissatisfaction||||>0.05
72596218|NCT03646305|144723988|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at a significance level of alpha .05 in a mixed ANOVA according to a power analysis using GPower 3.1. A 2 (Intervention: experimental, control) × 3 (Time: baseline, post-intervention, follow-up) mixed ANOVA was used to measure Time x Intervention interactions. Null: experimental and control conditions are equivalent in weight dissatisfaction across time.||||>0.05
72596219|NCT03646305|144723988|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect moderate effect size (.25) at significance level of alpha.05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA was used to analyze Time x Activity interaction. Null: Across time, there would be no difference between singing and verbal repetition on weight dissatisfaction||||>0.05
72596220|NCT03646305|144723988|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect moderate effect size (.25) at significance level of alpha .05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA used to analyze Time x Intervention x Activity interaction. Null: Across time, there would be no difference between four conditions on weight dissatisfaction||||>0.05
72596221|NCT03646305|144723989|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||<|0.001|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at significance level of alpha .05 in a mixed ANOVA according to a power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA was used to measure main effect of time. Null: Across the sample, appearance dissatisfaction were equivalent across time.||||<0.001
72596222|NCT03646305|144723989|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||t-test, 2 sided|||Paired sample t-tests was conducted to measure differences in appearance dissatisfaction from baseline to post-intervention. Null hypothesis: the control conditions would have no significant difference in appearance dissatisfaction from baseline to post-intervention||||>0.05
72596223|NCT03646305|144723989|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||<|0.001|||||||t-test, 2 sided|||Paired sample t-tests was conducted to measure differences in appearance dissatisfaction from post-intervention to follow-up. Null hypothesis: the control conditions would have no significant difference in appearance dissatisfaction from post-intervention to follow-up.||||<0.001
72596224|NCT03646305|144723989|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at significance level of alpha .05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA used to analyze main effect of Intervention. Null: On average, the experimental conditions and control conditions would have equal appearance dissatisfaction||||>0.05
72596225|NCT03646305|144723989|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at significance level of alpha .05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA was used to analyze main effect of Activity. Null: On average, singing and verbal repetition would result in equal appearance dissatisfaction scores||||>0.05
72596226|NCT03646305|144723989|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at significance level of alpha .05 in a mixed ANOVA according to a power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post-intervention, follow-up) mixed ANOVA used to analyze Intervention x Activity interaction. Null: On average, all four conditions were equivalent in appearance dissatisfaction||||>0.05
72415368|NCT01217073|144341415|SUPERIORITY_OR_OTHER||Difference in least squares mean|-0.71|||<|0.001|TWO_SIDED|95.0|-0.93|-0.5||With terms for treatment, prior AHA therapy status, geographic region (Japan/ex-Japan), and the interaction of time by treatment, time by prior AHA therapy status, with the constraint that the mean baseline is the same for all treatment groups.|Constrained longitudinal data analysis|||||-0.50|-0.93|<0.001
72415369|NCT01217073|144341415|SUPERIORITY_OR_OTHER||Difference in least squares mean|-0.67|||<|0.001|TWO_SIDED|95.0|-0.88|-0.45||With terms for treatment, prior AHA therapy status, geographic region (Japan/ex-Japan), and the interaction of time by treatment, time by prior AHA therapy status, with the constraint that the mean baseline is the same for all treatment groups.|Constrained longitudinal data analysis|||||-0.45|-0.88|<0.001
72596227|NCT03646305|144723989|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at a significance level of alpha .05 in a mixed ANOVA according to a power analysis using GPower 3.1. A 2 (Intervention: experimental, control) × 3 (Time: baseline, post-intervention, follow-up) mixed ANOVA was used to measure Time x Intervention interactions. Null: experimental and control conditions are equivalent in appearance dissatisfaction across time.||||>0.05
72596228|NCT03646305|144723989|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect moderate effect size (.25) at significance level of alpha.05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA used to analyze Time x Activity interaction. Null: Across time, there would be no difference between singing and verbal repetition on appearance dissatisfaction||||>0.05
72596229|NCT03646305|144723989|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect moderate effect size (.25) at significance level of alpha.05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA used to analyze Time x Intervention x Activity interaction. Null: Across time, there would be no difference between four conditions on appearance dissatisfaction||||>0.05
72596230|NCT03646305|144723990|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||<|0.001|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at significance level of alpha .05 in a mixed ANOVA according to a power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA was used to measure main effect of time. Null: Across the sample, body state image satisfaction were equivalent across time||||<0.001
72596231|NCT03646305|144723990|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||<|0.05|||||||t-test, 2 sided|||A paired sample t-test was conducted to measure the difference in state body image satisfaction from baseline to post intervention. Null hypothesis: there would be no significant differences in state body image satisfaction from baseline to post intervention.||||<0.05
72596232|NCT03646305|144723990|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||<|0.001|||||||t-test, 2 sided|||A paired sample t-test was conducted to measure the difference in state body image satisfaction from post intervention to follow-up. Null hypothesis: there would be no significant differences in state body image satisfaction from post-intervention to follow-up.||||<0.001
72415370|NCT01217073|144341415|SUPERIORITY_OR_OTHER||Difference in least squares mean|-0.49|||<|0.001|TWO_SIDED|95.0|-0.7|-0.27||With terms for treatment, prior AHA therapy status, geographic region (Japan/ex-Japan), and the interaction of time by treatment, time by prior AHA therapy status, with the constraint that the mean baseline is the same for all treatment groups.|Constrained longitudinal data analysis|||||-0.27|-0.70|<0.001
72415371|NCT01217073|144341415|SUPERIORITY_OR_OTHER||Difference in least squares mean|-0.5|||<|0.001|TWO_SIDED|95.0|-0.71|-0.28||With terms for treatment, prior AHA therapy status, geographic region (Japan/ex-Japan), and the interaction of time by treatment, time by prior AHA therapy status, with the constraint that the mean baseline is the same for all treatment groups.|Constrained longitudinal data analysis|||||-0.28|-0.71|<0.001
72415372|NCT01217073|144341415|SUPERIORITY_OR_OTHER||Difference in least squares mean|-0.28||||0.012|TWO_SIDED|95.0|-0.5|-0.06||With terms for treatment, prior AHA therapy status, geographic region (Japan/ex-Japan), and the interaction of time by treatment, time by prior AHA therapy status, with the constraint that the mean baseline is the same for all treatment groups.|Constrained longitudinal data analysis|||||-0.06|-0.50|0.012
72415373|NCT01217073|144341416|SUPERIORITY_OR_OTHER||Difference in percentage|6.2|||||TWO_SIDED|95.0|-6.2|18.4||||||||18.4|-6.2|
72415374|NCT01217073|144341416|SUPERIORITY_OR_OTHER||Difference in percentage|12.5|||||TWO_SIDED|95.0|-0.1|24.7||||||||24.7|-0.1|
72415375|NCT01217073|144341416|SUPERIORITY_OR_OTHER||Difference in percentage|5.9|||||TWO_SIDED|95.0|-6.5|18.0||||||||18.0|-6.5|
72415376|NCT01217073|144341416|SUPERIORITY_OR_OTHER||Difference in percentage|5.5|||||TWO_SIDED|95.0|-6.8|17.7||||||||17.7|-6.8|
72596233|NCT03646305|144723990|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect moderate effect size (.25) at significance level of alpha .05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA used to analyze main effect of Intervention. Null: On average, the experimental conditions and control conditions would have equal body state image satisfaction||||>0.05
72415377|NCT01217073|144341416|SUPERIORITY_OR_OTHER||Difference in percentage|2.4|||||TWO_SIDED|95.0|-9.8|14.5||||||||14.5|-9.8|
72415378|NCT01217073|144341417|SUPERIORITY_OR_OTHER||Difference in percentage|0.0|||||TWO_SIDED|95.0|-4.1|4.1||||||||4.1|-4.1|
72415379|NCT01217073|144341417|SUPERIORITY_OR_OTHER||Difference in percentage|-0.9|||||TWO_SIDED|95.0|-4.9|2.4||||||||2.4|-4.9|
72415380|NCT01217073|144341417|SUPERIORITY_OR_OTHER||Difference in percentage|0.0|||||TWO_SIDED|95.0|-4.1|4.0||||||||4.0|-4.1|
72415381|NCT01217073|144341417|SUPERIORITY_OR_OTHER||Difference in percentage|-0.9|||||TWO_SIDED|95.0|-4.9|2.4||||||||2.4|-4.9|
72415382|NCT01217073|144341417|SUPERIORITY_OR_OTHER||Difference in percentage|2.6|||||TWO_SIDED|95.0|-1.7|7.9||||||||7.9|-1.7|
72415383|NCT01217073|144341418|SUPERIORITY_OR_OTHER||Difference in percent|1.0|||||TWO_SIDED|95.0|-9.8|13.1||||||||13.1|-9.8|
72415384|NCT01217073|144341419|SUPERIORITY_OR_OTHER||Difference in percent|-1.4|||||TWO_SIDED|95.0|-9.1|2.6||||||||2.6|-9.1|
72415385|NCT01217073|144341420|SUPERIORITY_OR_OTHER||Difference in least squares mean|-44.9|||<|0.001|TWO_SIDED|95.0|-59.0|-30.7||With terms for treatment, prior AHA therapy status, geographic region (Japan/ex-Japan), and the interaction of time by treatment, time by prior AHA therapy status, with the constraint that the mean baseline is the same for all treatment groups.|Constrained longitudinal data analysis|||||-30.7|-59.0|<0.001
72415386|NCT01217073|144341420|SUPERIORITY_OR_OTHER||Difference in least squares mean|-41.6|||<|0.001|TWO_SIDED|95.0|-55.3|-27.8||With terms for treatment, prior AHA therapy status, geographic region (Japan/ex-Japan), and the interaction of time by treatment, time by prior AHA therapy status, with the constraint that the mean baseline is the same for all treatment groups.|Constrained longitudinal data analysis|||||-27.8|-55.3|<0.001
72415387|NCT01217073|144341420|SUPERIORITY_OR_OTHER||Difference in least squares mean|-35.1|||<|0.001|TWO_SIDED|95.0|-48.9|-21.3||With terms for treatment, prior AHA therapy status, geographic region (Japan/ex-Japan), and the interaction of time by treatment, time by prior AHA therapy status, with the constraint that the mean baseline is the same for all treatment groups.|Constrained longitudinal data analysis|||||-21.3|-48.9|<0.001
72415388|NCT01217073|144341420|SUPERIORITY_OR_OTHER||Difference in least squares mean|-33.5|||<|0.001||95.0|-47.3|-19.7||With terms for treatment, prior AHA therapy status, geographic region (Japan/ex-Japan), and the interaction of time by treatment, time by prior AHA therapy status, with the constraint that the mean baseline is the same for all treatment groups.|Constrained longitudinal data analysis|||||-19.7|-47.3|<0.001
72596234|NCT03646305|144723990|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at significance level of alpha .05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA was used to analyze main effect of Activity. Null: On average, singing and verbal repetition would result in equal state body satisfaction scores||||>0.05
72415389|NCT01217073|144341420|SUPERIORITY_OR_OTHER||Difference in least squares mean|-18.8||||0.009|TWO_SIDED|95.0|-32.9|-4.8||With terms for treatment, prior AHA therapy status, geographic region (Japan/ex-Japan), and the interaction of time by treatment, time by prior AHA therapy status, with the constraint that the mean baseline is the same for all treatment groups.|Constrained longitudinal data analysis|||||-4.8|-32.9|0.009
72415390|NCT01217073|144341421|SUPERIORITY_OR_OTHER||Difference in least squares mean|-21.4|||<|0.001|TWO_SIDED|95.0|-29.4|-13.4||With terms for treatment, prior AHA therapy status, geographic region (Japan/ex-Japan), and the interaction of time by treatment, time by prior AHA therapy status, with the constraint that the mean baseline is the same for all treatment groups.|Constrained longitudinal data analysis|||||-13.4|-29.4|<0.001
72415391|NCT01217073|144341421|SUPERIORITY_OR_OTHER||Difference in least squares mean|-13.5|||<|0.001|TWO_SIDED|95.0|-21.3|-5.7||With terms for treatment, prior AHA therapy status, geographic region (Japan/ex-Japan), and the interaction of time by treatment, time by prior AHA therapy status, with the constraint that the mean baseline is the same for all treatment groups.|Constrained longitudinal data analysis|||||-5.7|-21.3|<0.001
72596235|NCT03646305|144723990|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at significance level of alpha .05 in a mixed ANOVA according to a power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post-intervention, follow-up) mixed ANOVA used to analyze Intervention x Activity interaction. Null: On average, all four conditions were equivalent in state body image satisfaction||||>0.05
72415392|NCT01217073|144341421|SUPERIORITY_OR_OTHER||Difference in least squares mean|-14.3|||<|0.001|TWO_SIDED|95.0|-22.2|-6.3||With terms for treatment, prior AHA therapy status, geographic region (Japan/ex-Japan), and the interaction of time by treatment, time by prior AHA therapy status, with the constraint that the mean baseline is the same for all treatment groups.|Constrained longitudinal data analysis|||||-6.3|-22.2|<0.001
72415393|NCT01217073|144341421|SUPERIORITY_OR_OTHER||Difference in least squares mean|-19.0|||<|0.001|TWO_SIDED|95.0|-26.9|-11.2||With terms for treatment, prior AHA therapy status, geographic region (Japan/ex-Japan), and the interaction of time by treatment, time by prior AHA therapy status, with the constraint that the mean baseline is the same for all treatment groups.|Constrained longitudinal data analysis|||||-11.2|-26.9|<0.001
72596236|NCT03646305|144723990|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at a significance level of alpha .05 in a mixed ANOVA according to a power analysis using GPower 3.1. A 2 (Intervention: experimental, control) × 3 (Time: baseline, post-intervention, follow-up) mixed ANOVA was used to measure Time x Intervention interactions. Null: experimental and control conditions are equivalent in state body image satisfaction across time.||||>0.05
72596237|NCT03646305|144723990|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect moderate effect size (.25) at significance alpha level .05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA used to analyze Time x Activity interaction. Null: Across time, there would be no difference between singing and verbal repetition on state body image satisfaction||||>0.05
72596238|NCT03646305|144723990|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect moderate effect size (.25) at significance alpha level.05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA used to analyze Time x Intervention x Activity interaction. Null: Across time, there would be no difference between four conditions on state body image satisfaction||||>0.05
72596239|NCT03646305|144723991|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||<|0.001|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at significance level of alpha .05 in a mixed ANOVA according to a power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA was used to measure main effect of time. Null: Across the sample, state body image satisfaction were equivalent across time.||||<0.001
72596240|NCT03646305|144723991|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||<|0.001|||||||t-test, 2 sided|||A paired sample t-test was conducted to measure differences in anxious mood from baseline to post-intervention. Null hypothesis: there would be no significant difference in anxious mood from baseline to post-intervention.||||<0.001
72596241|NCT03646305|144723991|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||t-test, 2 sided|||Paired sample t-tests was conducted to measure differences in anxious mood from post-intervention to follow-up. Null hypothesis: there would be no significant difference in anxious mood from post-intervention to follow-up||||>0.05
72415394|NCT01217073|144341421|SUPERIORITY_OR_OTHER||Difference in least squares mean|-2.5||||0.539|TWO_SIDED|95.0|-10.4|5.5||With terms for treatment, prior AHA therapy status, geographic region (Japan/ex-Japan), and the interaction of time by treatment, time by prior AHA therapy status, with the constraint that the mean baseline is the same for all treatment groups.|Constrained longitudinal data analysis|||||5.5|-10.4|0.539
72415395|NCT01270347|144341492|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of the LS mean difference 95% CI for relative change from Baseline to Day 28 in FEV1 percent predicted was \> -4%.|LSMean difference|1.86||||0.1481|TWO_SIDED|95.0|-0.66|4.39|||ANCOVA||Estimates were determined from an analysis of covariance model with terms for treatment, region (US, non-US), and age (12 to 18 years, \> 18 years), and Baseline FEV1 (\< 55%, . 55%).|||4.39|-0.66|0.1481
72415396|NCT01270347|144341493|NON_INFERIORITY|Non-inferiority is demonstrated if the lower limit of the LS mean difference 95% CI for relative change from baseline to Day 28 in FEV1 percent predicted is \> -4%.|LSMean difference|4.968||||0.083|TWO_SIDED|95.0|-0.653|10.59|||ANCOVA||Estimates are determined from an ANCOVA model with terms for treatment, region (US, non-US), age (12-18 years, \>18 years), baseline FEV1 (\<55%, \>=55%), \& baseline as a covariate.|||10.590|-0.653|0.0830
72596242|NCT03646305|144723991|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at significance level of alpha .05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA was used to analyze main effect of Intervention. Null: On average, the experimental conditions and control conditions would have equal levels of anxiety||||>0.05
72596243|NCT03646305|144723991|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at significance level of alpha .05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA was used to analyze main effect of Activity. Null: On average, singing and verbal repetition would have equal levels of anxiety||||>0.05
72596244|NCT03646305|144723991|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||Twenty-eight participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at significance level of alpha .05 in a mixed ANOVA according to a power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post-intervention, follow-up) mixed ANOVA was used to analyze Intervention x Activity interaction. Null: On average, all four conditions were equivalent in levels of anxiety||||>0.05
72596245|NCT03646305|144723991|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at a significance level of alpha .05 in a mixed ANOVA according to a power analysis using GPower 3.1. A 2 (Intervention: experimental, control) × 3 (Time: baseline, post-intervention, follow-up) mixed ANOVA was used to measure Time x Intervention interactions. Null: experimental and control conditions are equivalent in levels of anxiety across time||||>0.05
72596246|NCT03646305|144723991|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect moderate effect size (.25) at significance level of alpha.05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA was used to analyze Time x Activity interaction. Null: Across time, there would be no difference between singing and verbal repetition on levels of anxiety||||>0.05
72415397|NCT01270347|144341494|NON_INFERIORITY|Non-inferiority is demonstrated if the lower limit of the LS mean difference 95% CI for relative change from baseline to Day 28 in FEV1 percent predicted is \> -4%.|LSMean difference|1.57||||0.0945|TWO_SIDED|95.0|-0.272|3.411|||ANCOVA||Estimates are determined from a repeated measures model with terms for treatment, visit, the interaction between treatment group and visit, region (US, non-US), age (12-18 years, \>18 years), baseline FEV1 (\<55%, \>=55%), and baseline as a covariate.|||3.411|-0.272|0.0945
72415398|NCT01270347|144341497|NON_INFERIORITY|Non-inferiority is demonstrated if the lower limit of the LS mean difference 95% CI for relative change from baseline to Day 28 in Pseudomonas Aeruginosa Sputum Density is \> -4%|LSMean difference|0.44||||0.053|TWO_SIDED|95.0|-0.01|0.88|||ANCOVA||Estimates are determined from an ANCOVA model with terms for treatment, region (US, non-US), age (12-18 years, \>18 years), baseline FEV1 (\<55%, \>=55%), and baseline organism log density.|||0.88|-0.01|0.0530
72415399|NCT01270347|144341499|NON_INFERIORITY|Non-inferiority is demonstrated if the lower limit of the LS mean difference 95% CI for relative change from baseline to Day 28 in Respiratory Domain of the CFQ-R is \> -4%|LSMean difference|3.19||||0.0463|TWO_SIDED|95.0|0.05|6.32|||ANCOVA||Estimates are determined from an ANCOVA model with terms for treatment, region (US, non-US), age (12-18 years, \>18 years), baseline FEV1 (\<55%, \>=55%), and baseline value.|||6.32|0.05|0.0463
72552498|NCT01811953|144635827|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMean), test/reference, for the primary endpoints using an acceptance range of 80.00 to 125.00%.|Geometric mean difference|100.81|STANDARD_ERROR_OF_MEAN|1.03|<|0.0001|TWO_SIDED|90.0|95.74|106.14|||ANOVA||The geometric mean ratio was calculated as the geometric mean of '5 Empagliflozin/Metformin (T)' divided by the geometric mean of '6 Empagliflozin + Metformin (R)'.|||106.14|95.74|<0.0001
72596247|NCT03646305|144723991|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect moderate effect size (.25) at significance level of alpha.05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA was used to analyze Time x Intervention x Activity interaction. Null: Across time, there would be no difference between the four conditions on levels of anxiety||||>0.05
72596248|NCT03646305|144723992|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||<|0.001|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at significance level of alpha .05 in a mixed ANOVA according to a power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA was used to measure main effect of time. Null: Across the sample, levels of depressive mood were equivalent across time.||||<0.001
72596249|NCT03646305|144723992|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||<|0.001|||||||t-test, 2 sided|||Paired sample t-tests was conducted to measure differences in depressive mood from depressive mood from baseline to post-intervention||||<0.001
72596250|NCT03646305|144723992|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||t-test, 2 sided|||Paired sample t-tests was conducted to measure differences in depressive mood from post-intervention to follow-up. Null hypothesis: there would be no significant differences in depressive mood from post-intervention to follow-up.||||>0.05
72596251|NCT03646305|144723992|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at significance level of alpha .05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA used to analyze main effect of Intervention. Null: On average, the experimental conditions and control conditions would have equal levels of depressive mood||||>0.05
72596252|NCT03646305|144723992|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at significance level of alpha .05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA was used to analyze main effect of Activity. Null: On average, singing and verbal repetition would result in equal levels of depressive mood||||>0.05
72596253|NCT03646305|144723992|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at significance level of alpha .05 in a mixed ANOVA according to a power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post-intervention, follow-up) mixed ANOVA was used to analyze Intervention x Activity interaction. Null: On average, all four conditions were equivalent in levels of depressive mood||||>0.05
72596254|NCT03646305|144723992|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at a significance level of alpha .05 in a mixed ANOVA according to a power analysis using GPower 3.1. A 2 (Intervention: experimental, control) × 3 (Time: baseline, post-intervention, follow-up) mixed ANOVA was used to measure Time x Intervention interactions. Null: experimental and control conditions are equivalent in levels of depressive mood across time||||>0.05
72596255|NCT03646305|144723992|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect moderate effect size (.25) at significance level of alpha.05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA used to analyze Time x Activity interaction. Null: Across time, there would be no difference between singing and verbal repetition on levels of depressive mood||||>0.05
72596256|NCT03646305|144723992|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect moderate effect size (.25) at significance level of alpha.05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA was used to analyze Time x Intervention x Activity interaction. Null: Across time, there would be no difference between 4 conditions on levels of depressive mood||||>0.05
72596257|NCT03646305|144723993|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at significance level of alpha .05 in a mixed ANOVA according to a power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA was used to measure main effect of time. Null: Across the sample, levels of happiness were equivalent across time||||>0.05
72596258|NCT03646305|144723993|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at significance level of alpha .05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA was used to analyze main effect of Intervention. Null: On average, the experimental conditions and control conditions would have equal levels of happiness||||>0.05
72596259|NCT03646305|144723993|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at significance level of alpha .05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA was used to analyze main effect of Activity. Null: On average, singing and verbal repetition would have equal levels of happiness||||>0.05
72596260|NCT03646305|144723993|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at significance level of alpha .05 in a mixed ANOVA according to a power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post-intervention, follow-up) mixed ANOVA was used to analyze Intervention x Activity interaction. Null: On average, all four conditions were equivalent in levels of happiness||||>0.05
72421585|NCT00548132|144354307|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.46|STANDARD_DEVIATION|0.05||0.05|TWO_SIDED|95.0|0.24|0.9|||Cochran-Mantel-Haenszel|This was calculated based on the assumption that only 85% of eligible patients will consent to the study.|The standard of care is the numerator and the intervention group is the denominator|The null hypothesis is that the Bloostream infection per 1000 catheter days will be similar in both groups. In 2004, 6122 catheter days occurred in by both ICUs. If 15% of these were excluded, then 5203 catheter days/year will be eligible for analysis. The difference in infection rates will reach statistical significance at 12 months with a P-value of 0.04. At 24 months, the P-value will be more significant at 0.006.||0.90|0.24|0.05
72421586|NCT01355458|144354374|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||GEE: Logit link function|Generalized Estimating Equation (GEE) methods with Logit link function and marginal expectation model.||||||<0.001
72415400|NCT02273141|144341504|NON_INFERIORITY_OR_EQUIVALENCE|The confidence limits were adjusted for multiple comparisons (two alternative primary endpoints): To be declared non-inferior, the primary endpoint must show a difference in success rates of no greater than 10% in favor of SP+MS using lower 1-sided 97.5% confidence limits. Calculated using exact Clopper-Pearson confidence limits.|Difference in success rate|8.22||||0.038|ONE_SIDED|97.5|-0.5|||The p-value was adjusted for multiple comparisons (2 alternative primary endpoints): To be declared superior, the primary endpoint must demonstrate non-inferiority with 1-sided p-value \<0.025, the threshold for statistical significance.|Fisher Exact|||The hypothesis was to demonstrate non-inferiority (NI) of NER1006 regimen to SP+MS (10% margin). Success rate was no. of patients with successful overall bowel cleansing as proportion of no. of patients in each group. Treatment effect was NER1006 success rate - SP+MS success rate. A Hochberg procedure was used to control Type I error since there were 2 alternative primary endpoints. An alpha level of 1.25% 1-sided was used. A closed testing procedure used to evaluate superiority if NI was met.|||-0.50|0.038
72415401|NCT02273141|144341505|NON_INFERIORITY_OR_EQUIVALENCE|The confidence limits were adjusted for multiple comparisons (two alternative primary endpoints): To be declared non-inferior the primary endpoint must show a difference in success rates of no greater than 10% in favor of SP+MS using lower 1-sided 97.5% confidence limits. Calculated using exact Clopper-Pearson confidence limits.|Difference in excellent plus good rate|3.2||||0.027|ONE_SIDED|97.5|-5.56|||The p-value was adjusted for multiple comparisons (2 alternative primary endpoints): To be declared superior, primary endpoint must demonstrate non-inferiority with 1-sided p-value \<0.025, the threshold for statistical significance.|Fisher Exact|||Hypothesis was to demonstrate NI of NER1006 regimen to SP+MS (10% margin). Success rate was no. of patients with highly effective cleansing of the colon ascendens as proportion of no. of patients in each group. Treatment effect was NER1006 success rate - SP+MS success rate. A Hochberg procedure was used to control Type I error since there were 2 alternative primary endpoints. An alpha level of 1.25% 1-sided was used. A closed testing procedure used to evaluate superiority if NI was met.|||-5.56|0.027
72415402|NCT02273141|144341506|NON_INFERIORITY_OR_EQUIVALENCE|To be declared non-inferior, the key secondary endpoint must show a difference in rates of no greater than 10% in favor of SP+MS using lower 1-sided 97.5% confidence limits. Calculated using exact Clopper-Pearson confidence limits.|Difference in ADR|2.42||||0.154|TWO_SIDED|95.0|-6.35|11.12||To be declared superior, the key secondary endpoint must demonstrate non-inferiority and show a significant advantage for NER1006 relative to SP+MS with 1-sided p-value \<0.025, the threshold for statistical significance.|Fisher Exact|||If at least one of the alternative primary endpoints was met, then key secondary endpoints for the same colon region as met by the primary endpoint were evaluated hierarchically in a pre-specified order. The difference in ADR was calculated as NER1006 rate - SP+MS rate using 1-sided 97.5% confidence limits. Formal testing was to proceed in the hierarchy if preceding key secondary endpoint met non-inferiority. This procedure ensured overall Type I error control at 2.5% 1-sided.||11.12|-6.35|0.154
72415403|NCT02273141|144341507|NON_INFERIORITY_OR_EQUIVALENCE|To be declared non-inferior, the key secondary endpoint must show a difference in rates of no greater than 10% in favor of SP+MS using lower 1-sided 97.5% confidence limits. Calculated using exact Clopper-Pearson confidence limits.|Difference in ADR|3.27||||0.212|TWO_SIDED|95.0|-5.56|11.91||To be declared superior, the key secondary endpoint must demonstrate non-inferiority and show a significant advantage for NER1006 relative to SP+MS with 1-sided p-value \<0.025, the threshold for statistical significance.|Fisher Exact|||If at least one of the alternative primary endpoints was met, then key secondary endpoints for the same colon region as met by the primary endpoint were evaluated hierarchically in a pre-specified order. The difference in ADR was calculated as NER1006 rate - SP+MS rate using 1-sided 97.5% confidence limits. Formal testing was to proceed in the hierarchy if preceding key secondary endpoint met non-inferiority. This procedure ensured overall Type I error control at 2.5% 1-sided.||11.91|-5.56|0.212
72415404|NCT02273141|144341508|NON_INFERIORITY_OR_EQUIVALENCE|To be declared non-inferior, the key secondary endpoint must show a difference in rates of no greater than 10% in favor of SP+MS using lower 1-sided 97.5% confidence limits. Calculated using exact Clopper-Pearson confidence limits.|Difference in PDR|4.43||||0.064|TWO_SIDED|95.0|-4.36|13.1||To be declared superior, the key secondary endpoint must demonstrate non-inferiority and show a significant advantage for NER1006 relative to SP+MS with 1-sided p-value \<0.025, the threshold for statistical significance.|Fisher Exact|||If at least one of the alternative primary endpoints was met, then key secondary endpoints for the same colon region as met by the primary endpoint were evaluated hierarchically in a pre-specified order. The difference in PDR was calculated as NER1006 rate - SP+MS rate using 1-sided 97.5% confidence limits. Formal testing was to proceed in the hierarchy if preceding key secondary endpoint met non-inferiority. This procedure ensured overall Type I error control at 2.5% 1-sided.||13.10|-4.36|0.064
72421587|NCT03720938|144354376|SUPERIORITY|A sample size of 26 children per group was needed with the assumption of Cohen's d = 0.8, the alpha error of 0.05 and a power of 80%.||||||0.001||||||The outcomes of weight was tested for any difference between groups by covariate analysis (ANCOVA) adjusted for the weight at baseline and confounding variable age.|ANCOVA|||Null hypothesis was the absence of difference between the two groups for the dependent variable weight.||||0.001
72421588|NCT03720938|144354376|OTHER|||||||0.0002535||||||Linear mixed-effects model fit by maximum likelihood since restricted maximum likelihood assumes a strong normality.|Linear mixed effects model|Adjusted for cluster effect, and small sample sizes in addition to baseline value and age.||Null hypothesis was the absence of difference between the two groups for the dependent variable weight.||||0.0002535
72596261|NCT03646305|144723993|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at a significance level of alpha .05 in a mixed ANOVA according to a power analysis using GPower 3.1. A 2 (Intervention: experimental, control) × 3 (Time: baseline, post-intervention, follow-up) mixed ANOVA was used to measure Time x Intervention interactions. Null: experimental and control conditions are equivalent in levels of happiness across time.||||>0.05
72596262|NCT03646305|144723993|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect moderate effect size (.25) at significance level of alpha.05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA was used to analyze Time x Activity interaction. Null: Across time, there would be no difference between singing and verbal repetition on levels of happiness||||>0.05
72596263|NCT03646305|144723993|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect moderate effect size (.25) at significance level of alpha.05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA was used to analyze Time x Intervention x Activity interaction. Null: Across time, there would be no differences between four conditions on levels of happiness||||>0.05
72596264|NCT03646305|144723994|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at significance level of alpha .05 in a mixed ANOVA according to a power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA was used to measure main effect of time. Null: Across the sample, levels of confidence were equivalent across time.||||>0.05
72596265|NCT03646305|144723994|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at significance level of alpha .05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA was used to analyze main effect of Intervention. Null: On average, the experimental conditions and control conditions would have equal levels of confidence||||>0.05
72415405|NCT02273141|144341509|NON_INFERIORITY_OR_EQUIVALENCE|To be declared non-inferior, the key secondary endpoint must show a difference in rates of no greater than 10% in favor of SP+MS using lower 1-sided 97.5% confidence limits. Calculated using exact Clopper-Pearson confidence limits.|Difference in PDR|2.95||||0.278|TWO_SIDED|95.0|-5.96|11.51||To be declared superior, the key secondary endpoint must demonstrate non-inferiority and show a significant advantage for NER1006 relative to SP+MS with 1-sided p-value \<0.025, the threshold for statistical significance.|Fisher Exact|||If at least one of the alternative primary endpoints was met, then key secondary endpoints for the same colon region as met by the primary endpoint were evaluated hierarchically in a pre-specified order. The difference in PDR was calculated as NER1006 rate - SP+MS rate using 1-sided 97.5% confidence limits. Formal testing was to proceed in the hierarchy if preceding key secondary endpoint met non-inferiority. This procedure ensured overall Type I error control at 2.5% 1-sided.||11.51|-5.96|0.278
72415406|NCT00529399|144341510|SUPERIORITY_OR_OTHER_LEGACY|||||||0.98|||||||ANCOVA|||"The calculation for the concentration of c-peptide is a weighted average of the 6 timed measurements of c-peptide in nano-moles/Liter. We try to distinguish this calculation from the AUC by referring to it as the AUC mean and may be expressed algebraically as the AUC/(120 min.); thus, the units are the same as the y-axis."||||0.98
72415407|NCT00529399|144341510|SUPERIORITY_OR_OTHER_LEGACY|||||||0.51|||||||ANCOVA|||"The calculation for the concentration of c-peptide is a weighted average of the 6 timed measurements of c-peptide in nano-moles/Liter. We try to distinguish this calculation from the AUC by referring to it as the AUC mean and may be expressed algebraically as the AUC/(120 min.); thus, the units are the same as the y-axis."||||0.51
72415408|NCT02486328|144341511|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||||||0.001
72415409|NCT02486328|144341512|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||||||0.001
72596266|NCT03646305|144723994|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at significance level of alpha .05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA was used to analyze main effect of Activity. Null: On average, singing and verbal repetition would result in equal levels of confidence||||>0.05
72596267|NCT03646305|144723994|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at significance level of alpha .05 in a mixed ANOVA according to a power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post-intervention, follow-up) mixed ANOVA was used to analyze Intervention x Activity interaction. Null: On average, all four conditions were equivalent in levels of confidence||||>0.05
72415410|NCT02486328|144341513|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||||||0.001
72415411|NCT02486328|144341514|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|||||||Kruskal-Wallis|||||||0.001
72415412|NCT02486328|144341515|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|||||||Kruskal-Wallis|||||||0.001
72415413|NCT02486328|144341516|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|||||||Kruskal-Wallis|||||||0.001
72415414|NCT03317977|144341521|SUPERIORITY|||||||0.43|||||||Mixed Models Analysis|||||||0.43
72415415|NCT04313881|144341524|SUPERIORITY||Odds Ratio (OR)|0.876||||0.5218|TWO_SIDED|95.0|0.585|1.312||2-sided P-value, odds ratio and its 95% CI were based on Cochran-Mantel-Haenszel (CMH) method stratified by stratification factors (geographic region, cytogenetic risk status, and bone marrow blast percentage).|Cochran-Mantel-Haenszel|||||1.312|0.585|0.5218
72415416|NCT04313881|144341525|SUPERIORITY||Hazard Ratio (HR)|1.203||||0.1299|TWO_SIDED|95.0|0.947|1.528||2-sided P-value was based on stratified log-rank test, stratified by stratification factors.|Log Rank||Hazard ratio and its 95% confidence interval (CI) were calculated using the Cox proportional hazards regression model, stratified by stratification factors.|||1.528|0.947|0.1299
72415417|NCT04313881|144341527|SUPERIORITY||Odds Ratio (OR)|0.821||||0.2563|TWO_SIDED|95.0|0.584|1.155||2-sided P-value, odds ratio and its 95% CI were based on Cochran-Mantel-Haenszel (CMH) method stratified by stratification factors (geographic region, cytogenetic risk status, and bone marrow blast percentage).|Cochran-Mantel-Haenszel|||||1.155|0.584|0.2563
72415418|NCT04313881|144341529|SUPERIORITY||Odds Ratio (OR)|0.72||||0.2191|TWO_SIDED|95.0|0.427|1.212||95% CI for transfusion independence rate was based on Clopper-Pearson exact method. 2-sided P-value, odds ratio and its 95% CI were based on Cochran-Mantel-Haenszel (CMH) method stratified by stratification factors.|Cochran-Mantel-Haenszel|||||1.212|0.427|0.2191
72596268|NCT03646305|144723994|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at a significance level of alpha .05 in a mixed ANOVA according to a power analysis using GPower 3.1. A 2 (Intervention: experimental, control) × 3 (Time: baseline, post-intervention, follow-up) mixed ANOVA was used to measure Time x Intervention interactions. Null: experimental and control conditions are equivalent in levels of confidence across time.||||>0.05
72596269|NCT03646305|144723994|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect moderate effect size (.25) at significance level of alpha.05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA was used to analyze Time x Activity interaction. Null: Across time, there would be no difference between singing and verbal repetition on levels of happiness||||>0.05
72596270|NCT03646305|144723994|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect moderate effect size (.25) at significance level of alpha.05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA was used to analyze Time x Intervention x Activity interaction. Null: Across time, there would be no differences between four conditions on levels of happiness||||>0.05
72596271|NCT03646305|144723995|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||<|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at significance level of alpha .05 in a mixed ANOVA according to a power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA was used to measure main effect of time. Null: Across the sample, level of self-esteem were equivalent across time.||||<0.05
72596272|NCT03646305|144723995|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||<|0.001|||||||t-test, 2 sided|||Paired sample t-tests was conducted to measure differences in self-esteem from post-intervention to follow-up. Null hypothesis: there would be no significant differences in self-esteem from post-intervention to follow-up.||||<0.001
72596273|NCT03646305|144723995|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at significance level of alpha .05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA was used to analyze main effect of Intervention. Null: On average, the experimental conditions and control conditions would have equal levels of self-esteem||||>0.05
72415419|NCT04313881|144341530|SUPERIORITY||Hazard Ratio (HR)|0.979||||0.8788|TWO_SIDED|95.0|0.746|1.285||2-sided P-value was based on stratified log-rank test, stratified by stratification factors.|Log Rank||Hazard ratio and its 95% CI were calculated using the Cox proportional hazards regression model, stratified by stratification factors.|||1.285|0.746|0.8788
72415420|NCT04313881|144341531|SUPERIORITY||Odds Ratio (OR)|0.441||||0.0375|TWO_SIDED|95.0|0.203|0.96||2-sided P-value, odds ratio and its 95% CI were based on unstratified Cochran-Mantel-Haenszel (CMH) method.|Cochran-Mantel-Haenszel||95% CI for response rate was based on Clopper-Pearson exact method.|||0.960|0.203|0.0375
72415421|NCT04313881|144341532|SUPERIORITY||Odds Ratio (OR)|0.947||||0.795|TWO_SIDED|95.0|0.629|1.426||2-sided P-value, odds ratio and its 95% CI were based on Cochran-Mantel-Haenszel (CMH) method stratified by stratification factors (geographic region, cytogenetic risk status, and bone marrow blast percentage).|Cochran-Mantel-Haenszel||95% CI for response rate was based on Clopper-Pearson exact method.|||1.426|0.629|0.7950
72596274|NCT03646305|144723995|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at significance level of alpha .05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA was used to analyze main effect of Activity. Null: On average, singing and verbal repetition would result in equal levels of self-esteem||||>0.05
72415422|NCT04313881|144341533|SUPERIORITY||Hazard Ratio (HR)|0.837||||0.461|TWO_SIDED|95.0|0.522|1.343||2-sided P-value was based on stratified log-rank test, stratified by stratification factors.|Log Rank||Hazard ratio and its 95% CI were calculated using the Cox proportional hazards regression model, stratified by stratification factors.|||1.343|0.522|0.4610
72596275|NCT03646305|144723995|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||Twenty-eight participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at significance level of alpha .05 in a mixed ANOVA according to a power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post-intervention, follow-up) mixed ANOVA used to analyze Intervention x Activity interaction. Null: On average, all four conditions have equivalent levels of self-esteem||||>0.05
72596276|NCT03646305|144723995|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at a significance level of alpha .05 in a mixed ANOVA according to a power analysis using GPower 3.1. A 2 (Intervention: experimental, control) × 3 (Time: baseline, post-intervention, follow-up) mixed ANOVA was used to measure Time x Intervention interactions. Null: experimental and control conditions have equivalent levels of self-esteem across time.||||>0.05
72596277|NCT03646305|144723995|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect moderate effect size (.25) at significance level of alpha.05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA was used to analyze Time x Activity interaction. Null: Across time, there would be no difference between singing and verbal repetition on levels of self-esteem||||>0.05
72596278|NCT03646305|144723995|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect moderate effect size (.25) at significance level of alpha.05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA was used to analyze Time x Intervention x Activity interaction. Null: Across time, there would be no differences between four conditions on levels of self-esteem||||>0.05
72596279|NCT03646305|144723996|OTHER|Mediation Analysis that examined whether greater homework adherence strengthened the relationship between condition and outcome|||||>|0.05|||||||Mediation Analyses|||All mediation analyses were conducted using the PROCESS SPSS macro version 3.2 (Hayes, 2018). We tested model 4, which includes one outcome variable, one predictor, one mediator, and room for covariates. We examined the meditational effect of homework adherence on the relationship between intervention and each outcome measure. Null: homework adherence does not mediate any relationships between intervention condition and outcome measures.||||>0.05
72596280|NCT03646305|144723996|OTHER|Mediation Analysis that examined whether greater homework adherence strengthened the relationship between condition and outcome|||||>|0.05|||||||Mediation Analyses|||All mediation analyses were conducted using the PROCESS SPSS macro version 3.2 (Hayes, 2018). We tested model 4, which includes one outcome variable, one predictor, one mediator, and room for covariates. We examined the meditational effect of homework adherence on the relationship between activity and each outcome measure. Null: homework adherence does not mediate any relationships between activity condition and outcome measures.||||>0.05
72596281|NCT03646305|144723997|OTHER|Thought-shape fusion was examined as a potential moderator of the relationship between intervention condition and outcome measures.|||||<|0.001||||||No other outcome measure was moderated by thought-shape fusion scores.|Moderation Analyses|||All moderation analyses were conducted using the PROCESS SPSS macro version 3.2 (Hayes, 2018). We tested model 1, which includes one outcome variable, one predictor, and one moderator. Thought-shape fusion was examined as a potential moderator of the relationship between intervention condition and outcome measures. Null: thought-shape fusion does not significantly moderate the relationship between intervention condition and state self-esteem||||<0.001
72596282|NCT03168919|144723998|OTHER|Comparison||||||||||||||||The baseline and the end of therapy MRI parameters are compared.|Due to very small accrual, the statistical analysis couln't be performed.|||
72596283|NCT00386425|144724010|SUPERIORITY_OR_OTHER|||||||0.011||95.0||||p-value is for change to Day 7|t-test, 2 sided|||||||0.011
72596284|NCT00386425|144724011|SUPERIORITY_OR_OTHER|||||||0.047||95.0||||p-value is for the moderate Protein C Deficiency (difference in change of pc between alt and standard groups)|t-test, 2 sided|||||||0.047
72596285|NCT00386425|144724011|SUPERIORITY_OR_OTHER|||||||0.063||95.0||||p-value is for the severe Protein C Deficiency (difference in change of pc between alt and standard groups)|t-test, 2 sided|||||||0.063
72596286|NCT00386425|144724012|SUPERIORITY_OR_OTHER|||||||0.03||95.0||||p-value is for Day 28 mortality|Fisher Exact|||||||0.030
72596287|NCT00386425|144724013|SUPERIORITY_OR_OTHER|||||||0.09||95.0||||p-value is for Day 90 mortality|Fisher Exact|||||||0.090
72596288|NCT00386425|144724014|SUPERIORITY_OR_OTHER|||||||0.19||95.0||||p-value is for total SOFA difference between alternative and standard therapy|t-test, 2 sided|||||||0.190
72596289|NCT00386425|144724014|SUPERIORITY_OR_OTHER|||||||0.268||95.0||||p-value is for difference in cardiovascular SOFA between alternative and standard therapy|t-test, 2 sided|||||||0.268
72596290|NCT00386425|144724014|SUPERIORITY_OR_OTHER|||||||0.082||95.0||||p-value is for difference in respiratory SOFA between alternative and standard therapy|t-test, 2 sided|||||||0.082
72415423|NCT04313881|144341534|SUPERIORITY||Hazard Ratio (HR)|1.02||||0.872|TWO_SIDED|95.0|0.802|1.297||2-sided P-value was based on stratified log-rank test, stratified by stratification factors (geographic region, cytogenetic risk status, and bone marrow blast percentage).|Log Rank||Hazard ratio and its 95% CI were calculated using the Cox proportional hazards regression model, stratified by stratification factors.|||1.297|0.802|0.8720
72415424|NCT04313881|144341535|SUPERIORITY|2-sided P-value, odds ratio and its 95% CI were based on Cochran-Mantel-Haenszel (CMH) method stratified by stratification factors|Odds Ratio (OR)|0.605||||0.0048|TWO_SIDED|95.0|0.428|0.857||2-sided P-value, odds ratio and its 95% CI were based on Cochran-Mantel-Haenszel (CMH) method stratified by stratification factors (geographic region, cytogenetic risk status, and bone marrow blast percentage).|Cochran-Mantel-Haenszel||95% CI for response rate was based on Clopper-Pearson exact method.|||0.857|0.428|0.0048
72596291|NCT00386425|144724014|SUPERIORITY_OR_OTHER|||||||0.367||95.0||||p-value is for difference in renal SOFA between alternative and standard therapy|t-test, 2 sided|||||||0.367
72596292|NCT00386425|144724014|SUPERIORITY_OR_OTHER|||||||0.274||95.0||||p-value is for difference in hematology SOFA between alternative and standard therapy|t-test, 2 sided|||||||0.274
72596293|NCT00386425|144724014|SUPERIORITY_OR_OTHER|||||||0.341||95.0||||p-value is for difference in liver SOFA between alternative and standard therapy|t-test, 2 sided|||||||0.341
72596294|NCT00386425|144724016|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||p-value is for difference between participants normalizing protein C and not normalizing protein C.|Fisher Exact|||||||<0.0001
72596295|NCT00386425|144724017|SUPERIORITY_OR_OTHER|||||||0.622||95.0||||p-value is for 28-Day Mortality, Dead at Day 28 vs. Alive at Day 28|Pearson's chi-square test|||||||0.622
72596296|NCT00386425|144724017|SUPERIORITY_OR_OTHER|||||||0.815||95.0||||p-value is for Hospital Mortality|Fisher Exact|||||||0.815
72596297|NCT03053427|144724025|SUPERIORITY||LSM difference|-1.2|STANDARD_ERROR_OF_MEAN|0.7||0.088|TWO_SIDED|95.0|-2.6|0.2|||Mixed Model of Repeated Measurements|||MMRM with compound symmetry as the covariance structure was used. The explanatory variables of the model included treatment group, IRLS score at baseline, age category, estimated creatinine clearance category, time point, and interaction of treatment group and time point.||0.2|-2.6|0.088
72596298|NCT03053427|144724026|SUPERIORITY||LSM difference|-1.1|STANDARD_ERROR_OF_MEAN|0.6||0.051|TWO_SIDED|95.0|-2.2|0.0|||ANCOVA|Time frame: week 1||LMS difference (gabapentin enacarbil group minus placebo group) of the changes in IRLS score from baseline was calculated by visit, using ANCOVA model with the baseline value as a covariate.||0.0|-2.2|0.051
72596299|NCT03053427|144724026|SUPERIORITY||LSM difference|-1.5|STANDARD_ERROR_OF_MEAN|0.7||0.02|TWO_SIDED|95.0|-2.8|-0.2|||ANCOVA|Time frame: week 2||LMS difference (gabapentin enacarbil group minus placebo group) of the changes in IRLS score from baseline was calculated by visit, using ANCOVA model with the baseline value as a covariate.||-0.2|-2.8|0.020
72596300|NCT03053427|144724026|SUPERIORITY||LSM difference|-1.5|STANDARD_ERROR_OF_MEAN|0.7||0.028|TWO_SIDED|95.0|-2.9|-0.2|||ANCOVA|Time frame: week 4||LMS difference (gabapentin enacarbil group minus placebo group) of the changes in IRLS score from baseline was calculated by visit, using ANCOVA model with the baseline value as a covariate.||-0.2|-2.9|0.028
72596301|NCT03053427|144724026|SUPERIORITY||LSM difference|-1.5|STANDARD_ERROR_OF_MEAN|0.7||0.043|TWO_SIDED|95.0|-2.9|0.0|||ANCOVA|Time frame: week 6||LMS difference (gabapentin enacarbil group minus placebo group) of the changes in IRLS score from baseline was calculated by visit, using ANCOVA model with the baseline value as a covariate.||-0.0|-2.9|0.043
72596302|NCT03053427|144724026|SUPERIORITY||LSM difference|-1.0|STANDARD_ERROR_OF_MEAN|0.7||0.184|TWO_SIDED|95.0|-2.4|0.5|||ANCOVA|Time frame: week 8||LMS difference (gabapentin enacarbil group minus placebo group) of the changes in IRLS score from baseline was calculated by visit, using ANCOVA model with the baseline value as a covariate.||0.5|-2.4|0.184
72596303|NCT03053427|144724026|SUPERIORITY||LSM difference|-1.7|STANDARD_ERROR_OF_MEAN|0.7||0.027|TWO_SIDED|95.0|-3.1|-0.2|||ANCOVA|Time frame: week 10||LMS difference (gabapentin enacarbil group minus placebo group) of the changes in IRLS score from baseline was calculated by visit, using ANCOVA model with the baseline value as a covariate.||-0.2|-3.1|0.027
72415425|NCT01572727|144341539|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.18|||||TWO_SIDED|95.0|0.82|1.68||||||||1.68|0.82|
72415426|NCT03998618|144341547|SUPERIORITY||partial correlation|0.12||||0.018|TWO_SIDED|95.0|-0.01|0.25||P-value for study group x time interaction. Two-tailed p-values \<.05 were considered statistically significant.|Mixed Models Analysis|degrees of freedom = 234. multiply imputed data were used in analyses.||||0.25|-0.01|.018
72415427|NCT03998618|144341548|SUPERIORITY||partial correlation|0.11||||0.037|TWO_SIDED|95.0|-0.02|0.24||P-value for study group x time interaction. Probabilities for the secondary outcomes were Sidak adjusted for correlated multiple outcomes (adjusted probability for significance = 0.0085).|Mixed Models Analysis|degrees of freedom = 234. Multiply imputed data were used.||||0.24|-0.02|.037
72596304|NCT03053427|144724026|SUPERIORITY||LSM difference|-1.4|STANDARD_ERROR_OF_MEAN|0.8||0.087|TWO_SIDED|95.0|-3.0|0.2|||ANCOVA|Time frame: week 12||LMS difference (gabapentin enacarbil group minus placebo group) of the changes in IRLS score from baseline was calculated by visit, using ANCOVA model with the baseline value as a covariate.||0.2|-3.0|0.087
72596305|NCT03053427|144724026|SUPERIORITY||LSM difference|-0.8|STANDARD_ERROR_OF_MEAN|0.8||0.312|TWO_SIDED|95.0|-2.4|0.8|||ANCOVA|Time frame: EoT||LMS difference (gabapentin enacarbil group minus placebo group) of the changes in IRLS score from baseline was calculated by visit, using ANCOVA model with the baseline value as a covariate.||0.8|-2.4|0.312
72596306|NCT03053427|144724027|SUPERIORITY||difference|4.2||||0.467|TWO_SIDED|95.0|-6.4|14.8|||Fisher Exact|||||14.8|-6.4|0.467
72596307|NCT03053427|144724028|SUPERIORITY||difference|5.8||||0.3|TWO_SIDED|95.0|-4.8|16.5|||Fisher Exact|||||16.5|-4.8|0.300
72596308|NCT03053427|144724029|SUPERIORITY||LSM difference|0.0|STANDARD_ERROR_OF_MEAN|0.3||0.877|TWO_SIDED|95.0|-0.5|0.5|||ANCOVA|||LMS difference (gabapentin enacarbil group minus placebo group) of the changes in PSQI component and global scores from baseline was calculated by visit, using the ANCOVA model with the baseline value as a covariate.||0.5|-0.5|0.877
72596309|NCT03053427|144724030|SUPERIORITY||LSM difference|0.0|STANDARD_ERROR_OF_MEAN|0.3||0.975|TWO_SIDED|95.0|-0.7|0.7|||ANCOVA|||LSM difference (gabapentin enacarbil group minus placebo group) of the changes in total score of Athens insomnia scale from baseline was calculated by visit, using the ANCOVA model with the baseline value as a covariate.||0.7|-0.7|0.975
72415428|NCT03998618|144341549|SUPERIORITY||partial correlation|0.07||||0.355|TWO_SIDED|95.0|-0.06|0.2||P-value for study group x time interaction. Probabilities for the secondary outcomes were Sidak adjusted for correlated multiple outcomes (adjusted probability for significance = 0.0085).|Mixed Models Analysis|degrees of freedom = 234. Multiply imputed data were used.||||0.20|-0.06|.355
72415429|NCT03998618|144341550|SUPERIORITY||partial correlation|0.08||||0.167|TWO_SIDED|95.0|-0.04|0.21||P-value for study group x time interaction for physical quality of life. Probabilities for the secondary outcomes were Sidak adjusted for correlated multiple outcomes (adjusted probability for significance=0.0085).|Mixed Models Analysis|degrees of freedom = 234. Multiply imputed data were used.||||0.21|-0.04|.167
72415430|NCT03998618|144341550|SUPERIORITY||partial correlation|0.09||||0.105|TWO_SIDED|95.0|-0.03|0.22||P-value for study group x time interaction for social/family quality of life. Probabilities for the six secondary outcomes were Sidak adjusted for correlated multiple outcomes (adjusted probability for significance=0.0085).|Mixed Models Analysis|degrees of freedom = 234. Multiply imputed data were used.||||0.22|-0.03|.105
72596310|NCT03053427|144724031|SUPERIORITY||LSM difference|0.0|STANDARD_ERROR_OF_MEAN|0.2||0.838|TWO_SIDED|95.0|-0.4|0.3|||ANCOVA|||LSM difference (gabapentin enacarbil group minus placebo group) of the changes in RLS pain score from baseline was calculated by visit, using the ANCOVA model with the baseline value as a covariate.||0.3|-0.4|0.838
72596311|NCT02172040|144724057|NON_INFERIORITY|Non-inferiority margin definition: lower limit of the 95% confidence interval (CI) for amlodipine + celecoxib arm did not cross the 50% value for the amlodipine arm.|||||=|0.001|||||||t-test, 1 sided|||A serial gatekeeping strategy was used for the primary efficacy endpoint analysis. The primary comparison was a two-sample t-test to test the one-sided hypothesis that treatment with amlodipine + celecoxib was non-inferior to half of the effect achieved with amlodipine.||||= 0.001
72596312|NCT02172040|144724057|SUPERIORITY||||||=|0.491|||||||t-test, 1 sided|||A serial gatekeeping strategy was used for the primary efficacy endpoint analysis. The secondary comparison was a two-sample t-test to test the one-sided hypothesis that treatment with placebo was superior to treatment with celecoxib. This was only to be performed if statistical significance was achieved for the primary comparison.||||= 0.491
72596313|NCT02172040|144724058|OTHER||||||=|0.166|||||||Chi-squared|||||||= 0.166
72596314|NCT02172040|144724059|SUPERIORITY|||||||0.177|||||||t-test, 1 sided|||||||0.177
72596315|NCT02172040|144724059|SUPERIORITY||||||<|0.001|||||||t-test, 1 sided|||||||<0.001
72596316|NCT02172040|144724059|SUPERIORITY||||||<|0.001|||||||t-test, 1 sided|||||||<0.001
72596317|NCT02172040|144724059|SUPERIORITY||||||<|0.001|||||||t-test, 1 sided|||||||<0.001
72596318|NCT02172040|144724059|SUPERIORITY||||||<|0.001|||||||t-test, 1 sided|||||||<0.001
72596319|NCT02172040|144724059|SUPERIORITY||||||=|0.719|||||||t-test, 1 sided|||||||= 0.719
72596320|NCT02172040|144724060|SUPERIORITY||||||=|0.069|||||||t-test, 1 sided|||||||= 0.069
72596321|NCT02172040|144724060|SUPERIORITY||||||=|0.001|||||||t-test, 1 sided|||||||= 0.001
72596322|NCT02172040|144724060|SUPERIORITY||||||<|0.001|||||||t-test, 1 sided|||||||<0.001
72596323|NCT02172040|144724060|SUPERIORITY||||||=|0.097|||||||t-test, 1 sided|||||||= 0.097
72596324|NCT02172040|144724060|SUPERIORITY||||||=|0.064|||||||t-test, 1 sided|||||||= 0.064
72596325|NCT02172040|144724060|SUPERIORITY||||||=|0.924|||||||t-test, 1 sided|||||||= 0.924
72596326|NCT02172040|144724061|SUPERIORITY||||||=|0.038|||||||t-test, 1 sided|||||||= 0.038
72596327|NCT02172040|144724061|SUPERIORITY||||||<|0.001|||||||t-test, 1 sided|||||||<0.001
72596328|NCT02172040|144724061|SUPERIORITY||||||<|0.001|||||||t-test, 1 sided|||||||<0.001
72596329|NCT02172040|144724061|SUPERIORITY||||||<|0.001|||||||t-test, 1 sided|||||||<0.001
72596330|NCT02172040|144724061|SUPERIORITY||||||<|0.001|||||||t-test, 1 sided|||||||<0.001
72596331|NCT02172040|144724061|SUPERIORITY||||||=|0.562|||||||t-test, 1 sided|||||||= 0.562
72596332|NCT02172040|144724062|SUPERIORITY||||||=|0.104|||||||t-test, 1 sided|||||||= 0.104
72596333|NCT02172040|144724062|SUPERIORITY||||||<|0.001|||||||t-test, 1 sided|||||||<0.001
72596334|NCT02172040|144724062|SUPERIORITY||||||<|0.001|||||||t-test, 1 sided|||||||<0.001
72596335|NCT02172040|144724062|SUPERIORITY||||||=|0.002|||||||t-test, 1 sided|||||||= 0.002
72596336|NCT02172040|144724062|SUPERIORITY||||||<|0.001|||||||t-test, 1 sided|||||||<0.001
72596337|NCT02172040|144724062|SUPERIORITY||||||=|0.419|||||||t-test, 1 sided|||||||= 0.419
72596338|NCT02172040|144724063|SUPERIORITY||||||=|0.028|||||||t-test, 1 sided|||||||= 0.028
72596339|NCT02172040|144724063|SUPERIORITY||||||<|0.001|||||||t-test, 1 sided|||||||<0.001
72596340|NCT02172040|144724063|SUPERIORITY||||||<|0.001|||||||t-test, 1 sided|||||||<0.001
72596341|NCT02172040|144724063|SUPERIORITY||||||=|0.051|||||||t-test, 1 sided|||||||= 0.051
72596342|NCT02172040|144724063|SUPERIORITY||||||=|0.074|||||||t-test, 1 sided|||||||= 0.074
72596343|NCT02172040|144724063|SUPERIORITY||||||=|0.878|||||||t-test, 1 sided|||||||= 0.878
72596344|NCT02172040|144724064|OTHER||||||<|0.001|||||||t-test, 1 sided|||||||<0.001
72596345|NCT02172040|144724065|OTHER||||||=|0.977|||||||t-test, 1 sided|||||||= 0.977
72596346|NCT02172040|144724066|OTHER||||||<|0.001|||||||t-test, 1 sided|||||||<0.001
72596347|NCT02172040|144724067|OTHER||||||=|0.527|||||||t-test, 1 sided|||||||= 0.527
72596348|NCT02172040|144724068|SUPERIORITY||||||<|0.001|||||||t-test, 1 sided|||||||<0.001
72596349|NCT02172040|144724068|SUPERIORITY||||||<|0.001|||||||t-test, 1 sided|||||||<0.001
72596350|NCT02172040|144724068|SUPERIORITY||||||<|0.001|||||||t-test, 1 sided|||||||<0.001
72596351|NCT02172040|144724068|SUPERIORITY||||||=|0.001|||||||t-test, 1 sided|||||||= 0.001
72596352|NCT03816644|144724069|SUPERIORITY||Odds Ratio (OR)|3.43|||||TWO_SIDED|95.0|2.32|5.07||||||The estimate of odds ratio, its 95% confidence interval and p-value are obtained from logistic regression models which were used to examine the difference in dementia care outcomes between the intervention and control groups at 90 days post screening visit. Models are adjusted for age, sex, and years of education.||5.07|2.32|
72596353|NCT03816644|144724070|SUPERIORITY||Odds Ratio (OR)|1.133|||||TWO_SIDED|95.0|0.837|1.534||||||The estimate of odds ratio, its 95% confidence interval and p-value are obtained from logistic regression models which were used to examine the difference in participants who were hospitalized or visited an ER 6 months post screening visit.||1.534|0.837|
72596354|NCT01801241|144724077|SUPERIORITY|||||||0.45|||||||t-test, 2 sided|||||||0.45
72596355|NCT02607306|144724118|NON_INFERIORITY|Non-inferiority of IDegLira vs. IDeg was confirmed if the 95% confidence interval for the mean treatment difference lies entirely below 0.3%.|Treatment contrast|-0.63|||<|0.0001|TWO_SIDED|95.0|-0.75|-0.52||p-value for non-inferiority of IDegLira vs IDeg is presented|ANCOVA|||The change from baseline in response after 52 weeks are analysed using an ANCOVA model with treatment and pre-trial OAD as fixed factors and baseline HbA1c value as covariate.||-0.52|-0.75|<0.0001
72596356|NCT02607306|144724118|SUPERIORITY|Superiority of IDegLira vs. Lira was confirmed if the 95% confidence interval for the mean treatment difference for change from baseline in HbA1c lies entirely below 0.0%.|Treatment contrast|-0.48|||<|0.0001|TWO_SIDED|95.0|-0.6|-0.37||p-value for superiority of IDegLira vs Lira is presented|ANCOVA|||The change from baseline in response after 52 weeks are analysed using an ANCOVA model with treatment and pre-trial OAD as fixed factors and baseline HbA1c value as covariate.||-0.37|-0.60|<0.0001
72415431|NCT03998618|144341550|SUPERIORITY||partial correlation|0.09||||0.142|TWO_SIDED|95.0|-0.04|0.22||P-value for study group x time interaction for emotional quality of life. Probabilities for the six secondary outcomes were Sidak adjusted for correlated multiple outcomes (adjusted probability for significance=0.0085).|Mixed Models Analysis|degrees of freedom = 234. Multiply imputed data were used.||||0.22|-0.04|.142
72415432|NCT03998618|144341550|SUPERIORITY||partial correlation|0.13||||0.006|TWO_SIDED|95.0|0.01|0.26||P-value for study group x time interaction for functional quality of life. Probabilities for the six secondary outcomes were Sidak adjusted for correlated multiple outcomes (adjusted probability for significance=0.0085).|Mixed Models Analysis|degrees of freedom = 234. Multiply imputed data were used.||||0.26|0.01|.006
72596357|NCT02607306|144724119|SUPERIORITY|A hierarchical testing procedure is used to control the overall type I error on a two sided 5% level. If and only if non-inferiority of IDegLira vs. IDeg and superiority of IDegLira vs. Lira are confirmed in the primary analysis (change in HbA1c), the three secondary confirmatory tests are performed for superiority of IDegLira versus IDeg with a fixed sequence (1. change in body weight, 2. number of treatment emergent severe or BG confirmed hypoglycaemic episodes and 3. change in HbA1c).|Treatment contrast|-1.19||||0.0001|TWO_SIDED|95.0|-1.8|-0.59||p-value for superiority of IDegLira vs IDeg is presented|ANCOVA|||The change from baseline in response after 52 weeks were analysed using an ANCOVA method with treatment and pre-trial OAD treatment as fixed factors and baseline body weight as covariate.||-0.59|-1.80|0.0001
72596358|NCT02607306|144724120|SUPERIORITY|A hierarchical testing procedure is used to control the overall type I error on a two sided 5% level. If and only if non-inferiority of IDegLira vs. IDeg and superiority of IDegLira vs. Lira are confirmed in the primary analysis (change in HbA1c), the three secondary confirmatory tests are performed for superiority of IDegLira versus IDeg with a fixed sequence (1. change in body weight, 2. number of treatment emergent severe or BG confirmed hypoglycaemic episodes and 3. change in HbA1c).|Treatment contrast|0.48|||<|0.0001|TWO_SIDED|95.0|0.35|0.68||p-value for superiority of IDegLira vs IDeg is presented|Negative binomial regression|||The number of events is analysed using a negative binomial regression model (log link) with the logarithm of the treatment emergent exposure time (100 years) as offset. The model includes treatment and pre-trial OAD treatment as fixed factors.||0.68|0.35|<0.0001
72596359|NCT02607306|144724121|SUPERIORITY|A hierarchical testing procedure is used to control the overall type I error on a two sided 5% level. If and only if non-inferiority of IDegLira vs. IDeg and superiority of IDegLira vs. Lira are confirmed in the primary analysis (change in HbA1c), the three secondary confirmatory tests are performed for superiority of IDegLira versus IDeg with a fixed sequence (1. change in body weight, 2. number of treatment emergent severe or BG confirmed hypoglycaemic episodes and 3. change in HbA1c).|Treatment contrast|-0.63|||<|0.0001|TWO_SIDED|95.0|-0.75|-0.52||p-value for superiority of IDegLira vs IDeg is presented|ANCOVA|||The change from baseline in response after 52 weeks are analysed using an ANCOVA model with treatment, pre-trial OAD as fixed factors and corresponding baseline HbA1c value as covariate.||-0.52|-0.75|<0.0001
72596360|NCT03240406|144724164|SUPERIORITY||Mean Difference (Net)|-0.06||||0.259|TWO_SIDED|95.0|-0.15|0.04||Test of the between arm difference in the global composite at Burst 2, adjusted for the study arm, baseline (Burst 1) global composite, and the randomization stratification factors (baseline sex, age, and years of education)|ANCOVA|ANCOVA of Burst 2 composite adjusted for arm, Burst 1 composite, sex, age, and education. Missing/invalid data were multiply imputed using MICE|Mean Difference of MHD Arm compared to control|||0.04|-0.15|0.259
72596361|NCT03240406|144724165|SUPERIORITY||Mean Difference (Net)|-0.64||||0.001|TWO_SIDED|95.0|-1.02|-0.27||MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|ANCOVA|MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|Mean Difference of MHD Arm vs Comparison Arm|||-0.27|-1.02|0.001
72596362|NCT03240406|144724166|SUPERIORITY||Mean Difference (Net)|-0.94|||<|0.001|TWO_SIDED|95.0|-1.34|-0.54||Estimated from ANCOVA model adjusted for baseline value, age, sex, and years of education at baseline.|ANCOVA|MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education.|Mean Difference of MHD Arm vs Comparison Arm|||-0.54|-1.34|<0.001
72596363|NCT03240406|144724167|SUPERIORITY||Mean Difference (Net)|0.24||||0.904|TWO_SIDED|95.0|-3.63|4.11||MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|ANCOVA|MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|Mean Difference of MHD Arm vs Comparison Arm|||4.11|-3.63|0.904
72596364|NCT03240406|144724168|SUPERIORITY||Mean Difference (Net)|-0.12||||0.721|TWO_SIDED|95.0|-0.76|0.52||MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, and education; tocopherol biomarker values additionally adjusted for Burst 1 and Burst 2 levels of HDL, LDL, and triglycerides|ANCOVA|Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education; Burst 1 and Burst 2 levels of HDL, LDL and triglycerides|Mean Difference of MHD Arm vs Comparison Arm|||0.52|-0.76|0.721
72596365|NCT03240406|144724169|SUPERIORITY||Mean Difference (Net)|0.0||||0.769|TWO_SIDED|95.0|-0.01|0.01||MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, and education; carotenoid biomarker values additionally adjusted for Burst 1 and Burst 2 levels of HDL, LDL, and triglycerides|ANCOVA|Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education; Burst 1 and Burst 2 levels of HDL, LDL and triglycerides|Mean Difference of MHD Arm vs Comparison Arm|||0.01|-0.01|0.769
72596366|NCT03240406|144724170|SUPERIORITY||Mean Difference (Net)|-1.37||||0.978|TWO_SIDED|95.0|-100.13|97.4||MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|ANCOVA|MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|Mean Difference of MHD Arm vs Comparison Arm|||97.4|-100.13|0.978
72415433|NCT02415400|144341564|NON_INFERIORITY|Non-Inferiority (NI) margin = 1.2|||||<|0.0001|||||||1-sided p-value for NI test|||Separate hierarchical testing was performed for apixaban vs VKA: 1) Non-inferiority for the primary endpoint.||||<0.0001
72415434|NCT02415400|144341564|SUPERIORITY||Hazard Ratio (HR)|0.69|||<|0.0001|TWO_SIDED|95.0|0.58|0.82|||2-sided p-value for superiority test|||Separate hierarchical testing was performed for apixaban vs VKA: 2) Superiority for the primary endpoint||0.82|0.58|<0.0001
72415435|NCT02415400|144341565|SUPERIORITY||Hazard Ratio (HR)|1.88|||<|0.0001|TWO_SIDED|95.0|1.58|2.23|||2-sided p-value for superiority test|||Separate hierarchical testing was performed for aspirin vs placebo: 2) Superiority for the primary endpoint.||2.23|1.58|<0.0001
72596367|NCT03240406|144724171|SUPERIORITY||Mean Difference (Net)|0.15||||0.395|TWO_SIDED|95.0|-0.2|0.51||MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|ANCOVA|MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|Mean Difference of MHD Arm vs Comparison Arm|Statistical Analysis results for Monounsaturated Fat||0.51|-0.2|0.395
72596368|NCT03240406|144724171|SUPERIORITY||Mean Difference (Net)|-0.11||||0.019|TWO_SIDED|95.0|-0.21|-0.02||MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|ANCOVA|MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|Mean Difference of MHD Arm vs Comparison Arm|Statistical Analysis results for Long Chain Saturated Fat||-0.02|-0.21|0.019
72596369|NCT03240406|144724171|SUPERIORITY||Mean Difference (Net)|0.12||||0.201|TWO_SIDED|95.0|-0.07|0.31||MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|ANCOVA|MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|Mean Difference of MHD Arm vs Comparison Arm|Statistical Analysis results for EPA||0.31|-0.07|0.201
72596370|NCT03240406|144724171|SUPERIORITY||Mean Difference (Net)|0.27||||0.039|TWO_SIDED|95.0|0.01|0.53||MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|ANCOVA|MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|Mean Difference of MHD Arm vs Comparison Arm|Statistical Analysis results for DHA||0.53|0.01|0.039
72415436|NCT02415400|144341566|SUPERIORITY||||||<|0.0001|||||||2-sided p-value for superiority test|||Separate hierarchical testing was performed for apixaban vs VKA: 2) Superiority for the primary endpoint.||||<0.0001
72415437|NCT02415400|144341567|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.0033|TWO_SIDED|95.0|0.75|0.94|||2-sided p-value|||Separate hierarchical testing was performed for apixaban vs VKA: 3) Superiority for all-cause death and all-cause rehospitalization.||0.94|0.75|0.0033
72415438|NCT02415400|144341568|SUPERIORITY||Hazard Ratio (HR)|1.07||||0.2219|TWO_SIDED|95.0|0.96|1.2|||2-sided p-value|||Separate hierarchical testing was performed for aspirin vs placebo: 3) Superiority for all-cause death and all-cause rehospitalization.||1.20|0.96|0.2219
72415439|NCT02415400|144341569|SUPERIORITY||Hazard Ratio (HR)|0.92||||0.437|TWO_SIDED|95.0|0.75|1.13|||2-sided p-value|||Separate hierarchical testing was performed for apixaban vs VKA: 4) Superiority for all-cause death and ischemic events.||1.13|0.75|0.4370
72415440|NCT02415400|144341570|SUPERIORITY||Hazard Ratio (HR)|0.86||||0.1742|TWO_SIDED|95.0|0.7|1.07|||2-sided p-value|||Separate hierarchical testing was performed for aspirin vs placebo: 4) Superiority for all-cause death and ischemic events.||1.07|0.70|0.1742
72415441|NCT02270450|144341571|SUPERIORITY||Mean Difference (Net)|2.87|STANDARD_ERROR_OF_MEAN|4.3||0.5|TWO_SIDED|||||A p-value less than 0.05 is considered statistically significant.|Regression, Linear|Adjusted for treatment, pathway, admitting attending physician specialty, Zubrod performance status, baseline albumin, and primary cancer site.|Comparing surgery to non-surgical management.|"A linear regression model was applied to the combined data from the randomized and Patient Choice (non-randomized) pathways, using the intention to treat principle with a treatment indicator variable (surgical vs non-surgical management) based on assignment. The model compares the number of good days between patients assigned to surgery and patients assigned to non-surgical management."||||0.50
72415442|NCT02270450|144341572|SUPERIORITY||Mean Difference (Net)|-1.09||||0.64|TWO_SIDED|||||For all secondary analyses, p-values should be interpreted cautiously as no adjustments for multiple comparisons were made.|Regression, Linear|Adjusted for treatment, pathway, admitting attending physician specialty, Zubrod performance status, baseline albumin, and primary cancer site.|Comparing surgery to non-surgical management.|A linear regression model was applied to the combined data from the randomized and Patient Choice (non-randomized) pathways, using the intention to treat principle with a treatment indicator variable (surgical vs non-surgical management) based on assignment. The model compares the length of the initial hospital stay between patients assigned to surgery and patients and patients assigned to non-surgical management. An interaction term between treatment and pathway was included.||||0.64
72415443|NCT02270450|144341573|SUPERIORITY||Odds Ratio (OR)|0.82||||0.6|TWO_SIDED|||||For all secondary analyses, p-values should be interpreted cautiously as no adjustments for multiple comparisons were made.|Regression, Logistic|Adjusted for treatment, pathway, admitting attending physician specialty, Zubrod performance status, baseline albumin, and primary cancer site.|Comparing surgery to non-surgical management.|A parallel logistic regression model was applied to the combined data from the randomized and Patient Choice (non-randomized) pathways, using the intention to treat principle with a treatment indicator variable (surgical vs non-surgical management) based on assignment. The model compares NG tube use vs no NG tube use between patients assigned to surgery and patients assigned to non-surgical management.||||0.60
72596371|NCT03240406|144724171|SUPERIORITY||Mean Difference (Net)|-0.01||||0.619|TWO_SIDED|95.0|-0.06|0.03||MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|ANCOVA|MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|Mean difference of MHD Arm vs Comparison Arm|Statistical Analysis results for n3 DPA||0.03|-0.06|0.619
72596372|NCT03240406|144724172|SUPERIORITY||Mean Difference (Net)|0.18||||0.521|TWO_SIDED|95.0|-0.37|0.73||MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|ANCOVA|MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|Mean Difference of MHD Arm vs Comparison Arm|||0.73|-0.37|0.521
72596373|NCT03240406|144724173|SUPERIORITY||Mean Difference (Net)|145.0||||0.101|TWO_SIDED|95.0|-27.7|317.6||MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|ANCOVA|MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|Mean Difference of MHD Arm vs Comparison Arm|||317.6|-27.7|0.101
72596374|NCT03240406|144724174|SUPERIORITY||Mean Difference (Net)|-24.63||||0.645|TWO_SIDED|95.0|-129.16|79.89||MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|ANCOVA|MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|Mean Difference of MHD Arm vs Comparison Arm|||79.89|-129.16|0.645
72596375|NCT03240406|144724175|SUPERIORITY||Mean Difference (Net)|3.26||||0.245|TWO_SIDED|95.0|-2.23|8.75||MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|ANCOVA|MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|Mean Difference of MHD Arm vs Comparison Arm|||8.75|-2.23|0.245
72415444|NCT02270450|144341574|SUPERIORITY||Mean Difference (Net)|0.64||||0.47|TWO_SIDED|||||For all secondary analyses, p-values should be interpreted cautiously as no adjustments for multiple comparisons were made.|Regression, Linear|Adjusted for treatment, pathway, admitting attending physician specialty, Zubrod performance status, baseline albumin, and primary cancer site.|Comparing surgery to non-surgical management.|A linear regression model was applied to the combined data from the randomized and Patient Choice (non-randomized) pathways, using the intention to treat principle with a treatment indicator variable (surgical vs non-surgical management) based on assignment. The model compares the number of days of NG tube use between patients assigned to surgery and patients and patients assigned to non-surgical management.||||0.47
72415445|NCT02270450|144341575|SUPERIORITY||Mean Difference (Net)|-4.1||||0.001|TWO_SIDED|||||For all secondary analyses, p-values should be interpreted cautiously as no adjustments for multiple comparisons were made.|Regression, Linear|Adjusted for treatment, pathway, admitting attending physician specialty, Zubrod performance status, baseline albumin, and primary cancer site.|Comparing surgery to non-surgical management.|A linear regression model was applied to the combined data from the randomized and Patient Choice (non-randomized) pathways, using the intention to treat principle with a treatment indicator variable (surgical vs non-surgical management) based on assignment. The model compares the MDASI-GI Symptom Assessment score for nausea severity between patients assigned to surgery and patients and patients assigned to non-surgical management. An interaction term between treatment and pathway was included.||||0.001
72596376|NCT03240406|144724176|SUPERIORITY||Mean Difference (Net)|0.21||||0.032|TWO_SIDED|95.0|0.02|0.4||MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|ANCOVA|MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|Mean Difference of MHD Arm vs Comparison Arm|||0.4|0.02|0.032
72596377|NCT03240406|144724177|SUPERIORITY||Mean Difference (Net)|0.17|||<|0.001|TWO_SIDED|95.0|0.08|0.26||MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|ANCOVA|MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|Mean Difference of MHD Arm vs Comparison Arm|||0.26|0.08|<0.001
72596378|NCT03240406|144724178|SUPERIORITY||Mean Difference (Net)|-1.36||||0.635|TWO_SIDED|95.0|-6.95|4.24||MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|ANCOVA|MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|Mean Difference of MHD Arm vs Comparison Arm|||4.24|-6.95|0.635
72596379|NCT03240406|144724179|SUPERIORITY||Mean Difference (Net)|-3.52||||0.019|TWO_SIDED|95.0|-6.44|0.59||MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|ANCOVA|MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|Mean Difference of MHD Arm vs Comparison Arm|||0.59|-6.44|0.019
72596380|NCT03240406|144724180|SUPERIORITY||Mean Difference (Net)|-3.13||||0.639|TWO_SIDED|95.0|-16.18|9.92||MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|ANCOVA|MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|Mean Difference of MHD Arm vs Comparison Arm|||9.92|-16.18|0.639
72596381|NCT03240406|144724181|SUPERIORITY||Mean Difference (Net)|41.71|||<|0.001|TWO_SIDED|95.0|21.47|61.96||MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|ANCOVA|MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|Mean Difference of MHD Arm vs Comparison Arm|||61.96|21.47|<0.001
72596382|NCT03240406|144724182|SUPERIORITY||Mean Difference (Net)|-15.37||||0.115|TWO_SIDED|95.0|-34.44|3.69||MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|ANCOVA|MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|Mean Difference of MHD Arm vs Comparison Arm|||3.69|-34.44|0.115
72596383|NCT03240406|144724183|SUPERIORITY||Mean Difference (Net)|0.06||||0.847|TWO_SIDED|95.0|-0.53|0.64||MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|ANCOVA|MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|Mean Difference of MHD Arm vs Comparison Arm|||0.64|-0.53|0.847
72596384|NCT03240406|144724184|SUPERIORITY||Mean Difference (Net)|118.57||||0.191|TWO_SIDED|95.0|-58.62|295.76||MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|ANCOVA|MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|Mean Difference of MHD Arm vs Comparison Arm|||295.76|-58.62|0.191
72596385|NCT03240406|144724185|SUPERIORITY||Mean Difference (Net)|955.19||||0.019|TWO_SIDED|95.0|164.63|1745.74||MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|ANCOVA|MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|Mean Difference of MHD Arm vs Comparison Arm|||1745.74|164.63|0.019
72421589|NCT03720938|144354376|SUPERIORITY|||||||0.000397||||||Linear mixed-effects model fit by maximum likelihood since restricted maximum likelihood assumes a strong normality.|Linear mixed-effects model|Adjusted by Satterthwaite's degrees of freedom method for cluster effect, and small sample sizes in addition to baseline value and age.||Null hypothesis was the absence of difference between the two groups for the dependent variable weight.||||0.000397
72596386|NCT03240406|144724186|SUPERIORITY||Mean Difference (Net)|-15.74||||0.493|TWO_SIDED|95.0|-60.66|29.19||MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|ANCOVA|MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|Mean Difference of MHD Arm vs Comparison Arm|||29.19|-60.66|0.493
72596387|NCT03240406|144724187|SUPERIORITY||Mean Difference (Net)|14.83||||0.18|TWO_SIDED|95.0|-6.78|36.45||MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|ANCOVA|MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|Mean Difference of MHD Arm vs Comparison Arm|||36.45|-6.78|0.18
72421590|NCT03720938|144354377|SUPERIORITY|||||||0.005||||||The outcome of weight z score was tested for any difference between groups by covariate analysis (ANCOVA) adjusted for the weight at baseline and confounding variable age.|ANCOVA|||Null hypothesis was the absence of difference between the two groups for the dependent variable weight z scores.||||0.005
72421591|NCT03720938|144354377|SUPERIORITY|||||||0.002||||||Linear mixed-effects model fit by maximum likelihood since restricted maximum likelihood assumes a strong normality.|Linear mixed effects model|Adjusted for cluster effect in addition to baseline value and age.||Null hypothesis was the absence of difference between the two groups for the dependent variable weight z score.||||0.002
72421592|NCT03720938|144354377|SUPERIORITY|||||||0.00386||||||Linear mixed-effects model fit by maximum likelihood since restricted maximum likelihood assumes a strong normality.|Linear mixed effects model|Adjusted by Satterthwaite's degrees of freedom method for cluster effect, and small sample sizes in addition to baseline value and age.||Linear mixed-effects model fit by maximum likelihood since restricted maximum likelihood assumes a strong normality. Adjusted by Satterthwaite's degrees of freedom correction method for cluster effect, and small sample sizes in addition to baseline value and age.||||0.00386
72596388|NCT03240406|144724188|SUPERIORITY||Mean Difference (Net)|436.14||||0.379|TWO_SIDED|95.0|-534.05|1406.33||MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|ANCOVA|MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|Mean Difference of MHD Arm vs Comparison Arm|||1406.33|-534.05|0.379
72596389|NCT03240406|144724189|SUPERIORITY||Mean Difference (Net)|784.06||||0.083|TWO_SIDED|95.0|-99.73|1667.85||MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|ANCOVA|MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|Mean Difference of MHD Arm vs Comparison Arm|||1667.85|-99.73|0.083
72596390|NCT03240406|144724190|SUPERIORITY||Mean Difference (Net)|1.33||||0.011|TWO_SIDED|95.0|0.32|2.35||MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|ANCOVA|MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|Mean Difference of MHD Arm vs Comparison Arm|||2.35|0.32|0.011
72596391|NCT03240406|144724191|SUPERIORITY||Mean Difference (Net)|0.07||||0.541|TWO_SIDED|95.0|-0.16|0.31||MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|ANCOVA|MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|Mean Difference of MHD Arm vs Comparison Arm|||0.31|-0.16|0.541
72596392|NCT03240406|144724192|SUPERIORITY||Mean Difference (Net)|0.01||||0.273|TWO_SIDED|95.0|-0.01|0.03||MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|ANCOVA|MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|Mean Difference of MHD Arm vs Comparison Arm|||0.03|-0.01|0.273
72596393|NCT03240406|144724193|SUPERIORITY||Mean Difference (Net)|0.03||||0.116|TWO_SIDED|95.0|-0.01|0.06||MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|ANCOVA|MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|Mean Difference of MHD Arm vs Comparison Arm|||0.06|-0.01|0.116
72596394|NCT03240406|144724194|SUPERIORITY||Mean Difference (Net)|0.0||||0.213|TWO_SIDED|95.0|0.0|0.01||MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|ANCOVA|MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|Mean Difference of MHD Arm vs Comparison Arm|||0.01|0|0.213
72596395|NCT03240406|144724195|SUPERIORITY||Mean Difference (Net)|0.05||||0.036|TWO_SIDED|95.0|0.0|0.09||MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|ANCOVA|MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|Mean Difference of MHD Arm vs Comparison Arm|||0.09|0|0.036
72596396|NCT03240406|144724196|SUPERIORITY||Mean Difference (Net)|0.17||||0.223|TWO_SIDED|95.0|-0.1|0.43||MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|ANCOVA|MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|Mean Difference of MHD Arm vs Comparison Arm|||0.43|-0.1|0.223
72596397|NCT03240406|144724197|SUPERIORITY||Mean Difference (Net)|-0.17||||0.119|TWO_SIDED|95.0|-0.38|0.04||MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|ANCOVA|MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|Mean Difference of MHD Arm vs Comparison Arm|||0.04|-0.38|0.119
72596398|NCT03240406|144724198|SUPERIORITY||Mean Difference (Net)|-0.04||||0.841|TWO_SIDED|95.0|-0.41|0.33||MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|ANCOVA|MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|Mean Difference of MHD Arm vs Comparison Arm|||0.33|-0.41|0.841
72596399|NCT03240406|144724199|SUPERIORITY||Mean Difference (Net)|0.25||||0.088|TWO_SIDED|95.0|-0.04|0.53||MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|ANCOVA|MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|Mean Difference of MHD Arm vs Comparison Arm|||0.53|-0.04|0.088
72596400|NCT03240406|144724200|SUPERIORITY||Mean Difference (Net)|-0.01||||0.893|TWO_SIDED|95.0|-0.13|0.11||MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|ANCOVA|MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|Mean Difference of MHD Arm vs Comparison Arm|||0.11|-0.13|0.893
72596401|NCT03240406|144724201|SUPERIORITY||Mean Difference (Net)|-1.43||||0.042|TWO_SIDED|95.0|-2.81|-0.06||MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|ANCOVA|MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|Mean Difference of MHD Arm vs Comparison Arm|||-0.06|-2.81|0.042
72596402|NCT03240406|144724202|SUPERIORITY||Slope|-16.0||||0.031|TWO_SIDED|95.0|-31.0|-1.5||Linear mixed-effects model adjusted for adjusted for arm, year, weekday, season, EMA cognition, baseline age, sex, education yrs, # of sessions (cubic spline), and time of day (cubic spline)|Mixed Models Analysis|Adjusted for arm, year, weekday, season, EMA cognition, baseline age, sex, education yrs, # of sessions (cubic spline), and time of day (cubic spline)|Difference in the slopes of processing speed over years between MHD Arm and Comparison Arm.|||-1.5|-31|0.031
72596403|NCT03240406|144724203|SUPERIORITY||Slope|0.12||||0.55|TWO_SIDED|95.0|-0.27|0.51||Linear mixed-effects model adjusted for arm, year, weekday, season, EMA cognition, baseline age, sex, education yrs, # of sessions (cubic spline), and time of day (cubic spline)|Mixed Models Analysis|Adjusted for arm, year, weekday, season, EMA cognition, baseline age, sex, education yrs, # of sessions (cubic spline), and time of day (cubic spline)|Difference in the slopes of error distance over years between MHD Arm vs Comparison Arm|||0.51|-0.27|0.55
72421593|NCT03720938|144354378|SUPERIORITY|||||||0||||||The outcomes of weight was tested for any difference between groups by covariate analysis (ANCOVA) adjusted for the body mass index at baseline and confounding variable age.|ANCOVA|||Null hypothesis was the absence of difference between the two groups for the dependent variable body mass index.||||0.000
72596404|NCT03240406|144724204|SUPERIORITY||Slope|-0.018||||0.846|TWO_SIDED|95.0|-0.09|0.054||Generalized Estimating equation Poisson model adjusted for arm, year, weekday vs weekend, season, EMA cognition, baseline age, sex, education yrs, # of sessions (cubic spline), time of day (cubic spline)|Generalized Estimating Equation|Adjusted for arm, year, wkday/wknd, season, EMA cognition, baseline age, sex, education yrs, # of sessions (cubic spline), time of day (cubic spline)|Difference in the slopes of log-transformed error rates over years between the MHD Arm and the Comparison Arm.|||0.054|-0.090|0.846
72596405|NCT00207727|144724225|SUPERIORITY_OR_OTHER|||||||0||95.0||||The p-value was non estimable because the observed trend was in the opposite direction of that stated in the one sided alternative hypothesis|Jonckheere Terpstra|Jonckheere Terpstra nonparametric trend test procedure with 5% level of significance was be used to test for the monotonic trend.||Hypothesis: The null hypothesis of no effect among the treatment groups was tested against the alternative hypothesis that the cumulative number of newly Gd-enhancing T1-weighted lesions on cranial MRIs through Week 23 would decrease monotonically with dose at a significance level of 0.05.||||0.00
72596406|NCT00207727|144724226|SUPERIORITY_OR_OTHER|||||||0.892||95.0|||||2-sided Wilcoxon Mann-Whitney|||||||0.892
72596407|NCT00207727|144724226|SUPERIORITY_OR_OTHER|||||||0.599||95.0|||||2-sided Wilcoxon Mann-Whitney|||||||0.599
72596408|NCT00207727|144724226|SUPERIORITY_OR_OTHER|||||||0.517||95.0|||||2-sided Wilcoxon Mann-Whitney|||||||0.517
72596409|NCT00207727|144724226|SUPERIORITY_OR_OTHER|||||||0.967||95.0|||||2-sided Wilcoxon Mann-Whitney|||Hypothesis: The null hypothesis is no difference between any ustekinumab treatment groups and placebo at a significant level of 0.05 for comparison for each treatment group.||||0.967
72596410|NCT00207727|144724227|SUPERIORITY_OR_OTHER|||||||0.72||95.0|||||Wilcoxon (Mann-Whitney)|2-sided Wilcoxon Mann-Whitney test (α = 0.05) used for each comparison with placebo||||||0.720
72596411|NCT00207727|144724227|SUPERIORITY_OR_OTHER|||||||0.152||95.0|||||Wilcoxon (Mann-Whitney)|2-sided Wilcoxon Mann-Whitney test (α = 0.05) used for each comparison with placebo||||||0.152
72596412|NCT00207727|144724227|SUPERIORITY_OR_OTHER|||||||0.431||95.0|||||Wilcoxon (Mann-Whitney)|2-sided Wilcoxon Mann-Whitney test (α = 0.05) used for each comparison with placebo||||||0.431
72596413|NCT00207727|144724227|SUPERIORITY_OR_OTHER|||||||0.292||95.0|||||Wilcoxon (Mann-Whitney)|2-sided Wilcoxon Mann-Whitney test (α = 0.05) used for each comparison with placebo||Hypothesis: The null hypothesis is no difference between any ustekinumab treatment groups and placebo at a significant level of 0.05 for comparison for each treatment group with placebo..||||0.292
72596414|NCT03759366|144724228|SUPERIORITY||Least Square Mean|-5.8||||0.0004|TWO_SIDED|95.0|-8.4|-3.13|||Repeated Measures Model||The least square mean change from baseline in QMG total score at Week 26 was calculated.|The observed change in QMG was analyzed with baseline QMG score and visits as covariates.||-3.13|-8.40|0.0004
72596415|NCT03759366|144724242|SUPERIORITY||Least Square Mean|-4.3||||0.0033|TWO_SIDED|95.0|-6.93|-1.65|||Repeated Measures Model||The least square mean change from baseline in QMG total score at Week 52 was calculated.|The observed change in QMG was analyzed with baseline QMG score and visits as covariates.||-1.65|-6.93|0.0033
72596416|NCT00435019|144724250|NON_INFERIORITY_OR_EQUIVALENCE|The null hypothesis for the non-inferiority test was that the mean HbA1c with insulin detemir was greater than or equal to the mean HbA1c with NPH insulin plus 0.4%. A sample size of 344 subjects, in total, with a drop-out rate of 20 percent would yield 274 subjects for evaluation of HbA1c. This would give 85 percent power to detect a difference in means of HbA1c of 0.4 percentage points assuming that the standard deviation was 1.1 using a two-sided t-test with a 0.05 significance level.|Mean Difference (Final Values)|0.12||||||95.0|-0.12|0.36|||ANCOVA|||||0.36|-0.12|
72596417|NCT02440854|144724284|OTHER|||||||0.002|||||||t-test, 2 sided|Paired t-test.||Baseline vs 2-month post-baseline.||||0.002
72596418|NCT02440854|144724284|OTHER|||||||0.014|||||||t-test, 2 sided|Paired t-test.||Baseline vs 4-month post-baseline.||||0.014
72596419|NCT02440854|144724284|OTHER|||||||0.246|||||||t-test, 2 sided|Paired t-test.||Baseline vs 6-month post-baseline.||||0.246
72596420|NCT02440854|144724284|OTHER|||||||0.103|||||||t-test, 2 sided|Paired t-test.||Baseline vs 8-month post-baseline.||||0.103
72596421|NCT02440854|144724284|OTHER|||||||0.004|||||||t-test, 2 sided|Paired t-test.||Baseline vs 10-month post-baseline.||||0.004
72596422|NCT02440854|144724284|OTHER||||||<|0.001|||||||t-test, 2 sided|Paired t-test.||Baseline vs 12-month post-baseline.||||<0.001
72596423|NCT02440854|144724284|OTHER|||||||0.012|||||||t-test, 2 sided|Paired t-test.||Baseline vs 18-month post-baseline.||||0.012
72596424|NCT02440854|144724284|OTHER|||||||0.024|||||||t-test, 2 sided|Paired t-test.||Baseline vs 24-month post-baseline.||||0.024
72596425|NCT02440854|144724284|OTHER|||||||0.009|||||||t-test, 2 sided|Paired t-test.||Baseline vs 30-month post-baseline.||||0.009
72596426|NCT02440854|144724284|OTHER|||||||0.008|||||||t-test, 2 sided|Paired t-test||Baseline vs 36-month post-baseline.||||0.008
72596427|NCT02440854|144724285|OTHER|||||||0.027|||||||t-test, 2 sided|Paired t-test.||Baseline vs 2-month post-baseline.||||0.027
72596428|NCT02440854|144724285|OTHER|||||||0.03|||||||t-test, 2 sided|Paired t-test.||Baseline vs 4-month post-baseline.||||0.030
72596429|NCT02440854|144724285|OTHER|||||||0.351|||||||t-test, 2 sided|Paired t-test.||Baseline vs 6-month post-baseline.||||0.351
72596430|NCT02440854|144724285|OTHER|||||||0.143|||||||t-test, 2 sided|Paired t-test.||Baseline vs 8-month post-baseline.||||0.143
72596431|NCT02440854|144724285|OTHER|||||||0.163|||||||t-test, 2 sided|Paired t-test.||Baseline vs 10-month post-baseline.||||0.163
72596432|NCT02440854|144724285|OTHER|||||||0.001|||||||t-test, 2 sided|Paired t-test.||Baseline vs 12-month post-baseline.||||0.001
72596433|NCT02440854|144724285|OTHER|||||||0.003|||||||t-test, 2 sided|Paired t-test.||Baseline vs 18-month post-baseline.||||0.003
72596434|NCT02440854|144724285|OTHER|||||||0.036|||||||t-test, 2 sided|Paired t-test.||Baseline vs 24-month post-baseline.||||0.036
72596435|NCT02440854|144724285|OTHER|||||||0.043|||||||t-test, 2 sided|Paired t-test.||Baseline vs 30-month post-baseline.||||0.043
72596436|NCT02440854|144724285|OTHER|||||||0.04|||||||t-test, 2 sided|Paired t-test||Baseline vs 36-month post-baseline.||||0.040
72596437|NCT02440854|144724286|OTHER||||||<|0.001|||||||t-test, 2 sided|Paired t-test.||Baseline vs 2-month post-baseline.||||<0.001
72596438|NCT02440854|144724286|OTHER|||||||0.003|||||||t-test, 2 sided|Paired t-test.||Baseline vs 4-month post-baseline.||||0.003
72596439|NCT02440854|144724286|OTHER||||||<|0.001|||||||t-test, 2 sided|Paired t-test.||Baseline vs 6-month post-baseline.||||<0.001
72596440|NCT02440854|144724286|OTHER||||||<|0.001|||||||t-test, 2 sided|Paired t-test.||Baseline vs 8-month post-baseline.||||<0.001
72596441|NCT02440854|144724286|OTHER||||||<|0.001|||||||t-test, 2 sided|Paired t-test.||Baseline vs 10-month post-baseline.||||<0.001
72596442|NCT02440854|144724286|OTHER||||||<|0.001|||||||t-test, 2 sided|Paired t-test.||Baseline vs 12-month post-baseline.||||<0.001
72596443|NCT02440854|144724286|OTHER||||||<|0.001|||||||t-test, 2 sided|Paired t-test.||Baseline vs 18-month post-baseline.||||<0.001
72596444|NCT02440854|144724286|OTHER||||||<|0.001|||||||t-test, 2 sided|Paired t-test.||Baseline vs 24-month post-baseline.||||<0.001
72596445|NCT02440854|144724286|OTHER||||||<|0.001|||||||t-test, 2 sided|Paired t-test.||Baseline vs 30-month post-baseline.||||<0.001
72596446|NCT02440854|144724286|OTHER|||||||0.163|||||||t-test, 2 sided|Paired t-test||Baseline vs 36-month post-baseline.||||0.163
72596447|NCT02440854|144724287|OTHER|||||||0.003|||||||t-test, 2 sided|Paired t-test.||Baseline vs 2-month post-baseline.||||0.003
72596448|NCT02440854|144724287|OTHER|||||||0.009|||||||t-test, 2 sided|Paired t-test.||Baseline vs 4-month post-baseline.||||0.009
72596449|NCT02440854|144724287|OTHER|||||||0.012|||||||t-test, 2 sided|Paired t-test.||Baseline vs 6-month post-baseline.||||0.012
72596450|NCT02440854|144724287|OTHER|||||||0.332|||||||t-test, 2 sided|Paired t-test.||Baseline vs 8-month post-baseline.||||0.332
72596451|NCT02440854|144724287|OTHER|||||||0.029|||||||t-test, 2 sided|Paired t-test.||Baseline vs 10-month post-baseline.||||0.029
72596452|NCT02440854|144724287|OTHER|||||||0.001|||||||t-test, 2 sided|Paired t-test.||Baseline vs 12-month post-baseline.||||0.001
72596453|NCT02440854|144724287|OTHER|||||||0.177|||||||t-test, 2 sided|Paired t-test.||Baseline vs 18-month post-baseline.||||0.177
72596454|NCT02440854|144724287|OTHER|||||||0.436|||||||t-test, 2 sided|Paired t-test.||Baseline vs 24-month post-baseline.||||0.436
72596455|NCT02440854|144724287|OTHER|||||||0.302|||||||t-test, 2 sided|Paired t-test.||Baseline vs 30-month post-baseline.||||0.302
72596456|NCT02440854|144724287|OTHER|||||||0.291|||||||t-test, 2 sided|Paired t-test||Baseline vs 36-month post-baseline.||||0.291
72596457|NCT02440854|144724288|OTHER||||||<|0.001|||||||t-test, 2 sided|Paired t-test.||Baseline vs 2-month post-baseline.||||<0.001
72596458|NCT02440854|144724288|OTHER||||||<|0.001|||||||t-test, 2 sided|Paired t-test.||Baseline vs 4-month post-baseline.||||<0.001
72596459|NCT02440854|144724288|OTHER||||||<|0.001|||||||t-test, 2 sided|Paired t-test.||Baseline vs 6-month post-baseline.||||<0.001
72596460|NCT02440854|144724288|OTHER||||||<|0.001|||||||t-test, 2 sided|Paired t-test.||Baseline vs 8-month post-baseline.||||<0.001
72596461|NCT02440854|144724288|OTHER||||||<|0.001|||||||t-test, 2 sided|Paired t-test.||Baseline vs 10-month post-baseline.||||<0.001
72596462|NCT02440854|144724288|OTHER||||||<|0.001|||||||t-test, 2 sided|Paired t-test.||Baseline vs 12-month post-baseline.||||<0.001
72596463|NCT02440854|144724288|OTHER||||||<|0.001|||||||t-test, 2 sided|Paired t-test.||Baseline vs 18-month post-baseline.||||<0.001
72596464|NCT02440854|144724288|OTHER||||||<|0.001|||||||t-test, 2 sided|Paired t-test.||Baseline vs 24-month post-baseline.||||<0.001
72596465|NCT02440854|144724288|OTHER|||||||0.002|||||||t-test, 2 sided|Paired t-test.||Baseline vs 30-month post-baseline.||||0.002
72596466|NCT02440854|144724288|OTHER|||||||0.025|||||||t-test, 2 sided|Paired t-test||Baseline vs 36-month post-baseline.||||0.025
72596467|NCT02440854|144724289|OTHER||||||<|0.001|||||||t-test, 2 sided|Paired t-test.||Baseline vs 2-month post-baseline.||||<0.001
72596468|NCT02440854|144724289|OTHER||||||<|0.001|||||||t-test, 2 sided|Paired t-test.||Baseline vs 4-month post-baseline.||||<0.001
72596469|NCT02440854|144724289|OTHER||||||<|0.001|||||||t-test, 2 sided|Paired t-test.||Baseline vs 6-month post-baseline.||||<0.001
72596470|NCT02440854|144724289|OTHER||||||<|0.001|||||||t-test, 2 sided|Paired t-test.||Baseline vs 8-month post-baseline.||||<0.001
72596471|NCT02440854|144724289|OTHER||||||<|0.001|||||||t-test, 2 sided|Paired t-test.||Baseline vs 10-month post-baseline.||||<0.001
72596472|NCT02440854|144724289|OTHER||||||<|0.001|||||||t-test, 2 sided|Paired t-test.||Baseline vs 12-month post-baseline.||||<0.001
72596473|NCT02440854|144724289|OTHER||||||<|0.001|||||||t-test, 2 sided|Paired t-test.||Baseline vs 18-month post-baseline.||||<0.001
72596474|NCT02440854|144724289|OTHER||||||<|0.001|||||||t-test, 2 sided|Paired t-test.||Baseline vs 24-month post-baseline.||||<0.001
72596475|NCT02440854|144724289|OTHER|||||||0.003|||||||t-test, 2 sided|Paired t-test.||Baseline vs 30-month post-baseline.||||0.003
72596476|NCT02440854|144724289|OTHER|||||||0.025|||||||t-test, 2 sided|Paired t-test||Baseline vs 36-month post-baseline.||||0.025
72596477|NCT02440854|144724290|OTHER||||||<|0.001|||||||t-test, 2 sided|Paired t-test.||Baseline vs 2-month post-baseline.||||<0.001
72596478|NCT02440854|144724290|OTHER||||||<|0.001|||||||t-test, 2 sided|Paired t-test.||Baseline vs 4-month post-baseline.||||<0.001
72596479|NCT02440854|144724290|OTHER||||||<|0.001|||||||t-test, 2 sided|Paired t-test.||Baseline vs 6-month post-baseline.||||<0.001
72596480|NCT02440854|144724290|OTHER||||||<|0.001|||||||t-test, 2 sided|Paired t-test.||Baseline vs 8-month post-baseline.||||<0.001
72596481|NCT02440854|144724290|OTHER||||||<|0.001|||||||t-test, 2 sided|Paired t-test.||Baseline vs 10-month post-baseline.||||<0.001
72596482|NCT02440854|144724290|OTHER||||||<|0.001|||||||t-test, 2 sided|Paired t-test.||Baseline vs 12-month post-baseline.||||<0.001
72596483|NCT02440854|144724290|OTHER||||||<|0.001|||||||t-test, 2 sided|Paired t-test.||Baseline vs 18-month post-baseline.||||<0.001
72596484|NCT02440854|144724290|OTHER||||||<|0.001|||||||t-test, 2 sided|Paired t-test.||Baseline vs 24-month post-baseline.||||<0.001
72596485|NCT02440854|144724290|OTHER||||||<|0.001|||||||t-test, 2 sided|Paired t-test.||Baseline vs 30-month post-baseline.||||<0.001
72596486|NCT02440854|144724290|OTHER||||||<|0.001|||||||t-test, 2 sided|Paired t-test||Baseline vs 36-month post-baseline.||||<0.001
72596487|NCT02440854|144724291|OTHER||||||<|0.001|||||||t-test, 2 sided|Paired t-test.||Baseline vs 2-month post-baseline.||||<0.001
72596488|NCT02440854|144724291|OTHER||||||<|0.001|||||||t-test, 2 sided|Paired t-test.||Baseline vs 4-month post-baseline.||||<0.001
72421594|NCT03720938|144354378|SUPERIORITY|||||||3.06e-06||||||"Linear mixed-effects model fit by maximum likelihood since restricted maximum likelihood assumes a strong normality.~Adjusted for cluster effect, and small sample sizes, baseline value and age."|Linear mixed effects model|Satterthwaite's correction method for denominator degrees of freedom.||Null hypothesis was the absence of difference between the two groups for the dependent variable body mass index.||||0.00000306
72596489|NCT02440854|144724291|OTHER||||||<|0.001|||||||t-test, 2 sided|Paired t-test.||Baseline vs 6-month post-baseline.||||<0.001
72421595|NCT03720938|144354378|SUPERIORITY|||||||3.67e-06||||||Linear mixed-effects model fit by maximum likelihood since restricted maximum likelihood assumes a strong normality.|Linear mixed effects model|Adjusted by Satterthwaite's degrees of freedom method for cluster effect, and small sample sizes in addition to baseline value and age.||Null hypothesis was the absence of difference between the two groups for the dependent variable body mass index.||||0.00000367
72596490|NCT02440854|144724291|OTHER||||||<|0.001|||||||t-test, 2 sided|Paired t-test.||Baseline vs 8-month post-baseline.||||<0.001
72415446|NCT02270450|144341575|SUPERIORITY||Mean Difference (Net)|-1.63||||0.008|TWO_SIDED|||||For all secondary analyses, p-values should be interpreted cautiously as no adjustments for multiple comparisons were made.|Regression, Linear|Adjusted for treatment, pathway, admitting attending physician specialty, Zubrod performance status, baseline albumin, and primary cancer site.|Comparing surgery to non-surgical management.|A linear regression model was applied to the combined data from the randomized and Patient Choice (non-randomized) pathways, using the intention to treat principle with a treatment indicator variable (surgical vs non-surgical management) based on assignment. The model compares the MDASI-GI Symptom Assessment score for vomiting severity between patients assigned to surgery and patients and patients assigned to non-surgical management.||||0.008
72596491|NCT02440854|144724291|OTHER||||||<|0.001|||||||t-test, 2 sided|Paired t-test.||Baseline vs 10-month post-baseline.||||<0.001
72596492|NCT02440854|144724291|OTHER||||||<|0.001|||||||t-test, 2 sided|Paired t-test.||Baseline vs 12-month post-baseline.||||<0.001
72415447|NCT02270450|144341575|SUPERIORITY||Mean Difference (Net)|-1.31||||0.04|TWO_SIDED|||||For all secondary analyses, p-values should be interpreted cautiously as no adjustments for multiple comparisons were made.|Regression, Linear|Adjusted for treatment, pathway, admitting attending physician specialty, Zubrod performance status, baseline albumin, and primary cancer site.|Comparing surgery to non-surgical management.|A linear regression model was applied to the combined data from the randomized and Patient Choice (non-randomized) pathways, using the intention to treat principle with a treatment indicator variable (surgical vs non-surgical management) based on assignment. The model compares the MDASI-GI Symptom Assessment score for bloating severity between patients assigned to surgery and patients and patients assigned to non-surgical management.||||0.04
72415448|NCT02270450|144341575|SUPERIORITY||Mean Difference (Net)|-3.6||||0.01|TWO_SIDED|||||For all secondary analyses, p-values should be interpreted cautiously as no adjustments for multiple comparisons were made.|Regression, Linear|Adjusted for treatment, pathway, admitting attending physician specialty, Zubrod performance status, baseline albumin, and primary cancer site.|Comparing surgery to non-surgical management.|A linear regression model was applied to the combined data from the randomized and Patient Choice (non-randomized) pathways, using the intention to treat principle with a treatment indicator variable (surgical vs non-surgical management) based on assignment. The model compares the MDASI-GI Symptom Assessment score for pain severity between patients assigned to surgery and patients and patients assigned to non-surgical management. An interaction term between treatment and pathway was included.||||0.01
72415449|NCT02270450|144341575|SUPERIORITY||Mean Difference (Net)|-1.9||||0.007|TWO_SIDED|||||For all secondary analyses, p-values should be interpreted cautiously as no adjustments for multiple comparisons were made.|Regression, Linear|Adjusted for treatment, pathway, admitting attending physician specialty, Zubrod performance status, baseline albumin, and primary cancer site.|Comparing surgery to non-surgical management.|A linear regression model was applied to the combined data from the randomized and Patient Choice (non-randomized) pathways, using the intention to treat principle with a treatment indicator variable (surgical vs non-surgical management) based on assignment. The model compares the MDASI-GI Symptom Assessment score for constipation severity between patients assigned to surgery and patients and patients assigned to non-surgical management.||||0.007
72415450|NCT02270450|144341576|SUPERIORITY||Odds Ratio (OR)|0.64||||0.52|TWO_SIDED|||||For all secondary analyses, p-values should be interpreted cautiously as no adjustments for multiple comparisons were made.|Regression, Logistic|Adjusted for treatment, admitting attending physician specialty, Zubrod performance status, baseline albumin, and primary cancer site.|Comparing surgery to non-surgical management.|A parallel logistic regression model was applied to the combined data from the randomized and Patient Choice (non-randomized) pathways, using the intention to treat principle with a treatment indicator variable (surgical vs non-surgical management) based on assignment. The model compares ability to eat between patients assigned to surgery and patients and patients assigned to non-surgical management.||||0.52
72415451|NCT02270450|144341577|SUPERIORITY||Hazard Ratio (HR)|0.7||||0.12|TWO_SIDED|95.0|0.45|1.09|||Regression, Cox|Adjusted for treatment, pathway, admitting attending physician specialty, Zubrod performance status, baseline albumin, and primary cancer site.|Comparing surgery to non-surgical management.|A Cox proportional hazards regression model stratified by pathway (randomized vs Patient Choice) was used to estimate the effect of treatment assignment (surgery vs non-surgical management) on overall survival.||1.09|0.45|0.12
72415452|NCT03265600|144341594|SUPERIORITY||Odds Ratio (OR)|2.91||||0.006|TWO_SIDED||||||Unadjusted bivariate logistic regression|||||||0.006
72415453|NCT03265600|144341595|SUPERIORITY|||||||0.19|||||||Mixed Models Analysis|Cohen's d: -0.25||||||0.19
72415454|NCT03265600|144341596|SUPERIORITY|||||||0.12|||||||Mixed Models Analysis|Cohen's d: -0.36||||||0.12
72415455|NCT03265600|144341597|SUPERIORITY|||||||0.08|||||||Mixed Models Analysis|Cohen's d: -0.34||||||0.08
72415456|NCT03265600|144341598|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|Cohen's d: 0.57||||||<0.001
72415457|NCT03265600|144341599|SUPERIORITY|||||||0.03|||||||Mixed Models Analysis|Cohen's d: 0.41||||||0.03
72415458|NCT03265600|144341600|SUPERIORITY|||||||0.31|||||||Mixed Models Analysis|Cohen's d: 0.15||||||0.31
72415459|NCT03265600|144341601|SUPERIORITY|||||||0.26|||||||Mixed Models Analysis|Cohen's d: 0.22||||||0.26
72415460|NCT03265600|144341602|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|Cohen's d: -0.58||||||<0.001
72415461|NCT03265600|144341603|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|Cohen's d: 0.75||||||<0.001
72415462|NCT02512575|144341662|SUPERIORITY_OR_OTHER||Slope|0.847|STANDARD_ERROR_OF_MEAN|0.0238|||TWO_SIDED|90.0|0.807|0.887||||||||0.887|0.807|
72415463|NCT02512575|144341665|SUPERIORITY_OR_OTHER||Slope|0.93|STANDARD_ERROR_OF_MEAN|0.0364|||TWO_SIDED|90.0|0.869|0.991||||||||0.991|0.869|
72415464|NCT02512575|144341666|SUPERIORITY_OR_OTHER||Slope|0.917|STANDARD_ERROR_OF_MEAN|0.0364|||TWO_SIDED|90.0|0.856|0.978||||||||0.978|0.856|
72415465|NCT02512575|144341667|SUPERIORITY_OR_OTHER||Ratio (Active Vs Placebo)|1.03|||||TWO_SIDED|90.0|0.96|1.11||||||||1.11|0.960|
72415466|NCT02512575|144341667|SUPERIORITY_OR_OTHER||Ratio (Active Vs Placebo)|1.0|||||TWO_SIDED|90.0|0.929|1.08||||||||1.08|0.929|
72415467|NCT02512575|144341667|SUPERIORITY_OR_OTHER||Ratio (Active Vs Placebo)|1.06|||||TWO_SIDED|90.0|0.987|1.14||||||||1.14|0.987|
72415468|NCT02512575|144341667|SUPERIORITY_OR_OTHER||Ratio (Active Vs Placebo)|1.06|||||TWO_SIDED|95.0|0.983|1.13||||||||1.13|0.983|
72415469|NCT02512575|144341667|SUPERIORITY_OR_OTHER||Ratio (Active Vs Placebo)|1.07|||||TWO_SIDED|90.0|0.995|1.15||||||||1.15|0.995|
72415470|NCT02512575|144341667|SUPERIORITY_OR_OTHER||Ratio (Active Vs Placebo)|1.17|||||TWO_SIDED|90.0|1.09|1.25||||||||1.25|1.09|
72415471|NCT02512575|144341667|SUPERIORITY_OR_OTHER||Ratio (Active Vs Placebo)|1.15|||||TWO_SIDED|90.0|1.07|1.24||||||||1.24|1.07|
72415472|NCT02512575|144341667|SUPERIORITY_OR_OTHER||Ratio (Active Vs Placebo)|1.2|||||TWO_SIDED|90.0|1.11|1.29||||||||1.29|1.11|
72415473|NCT02512575|144341667|SUPERIORITY_OR_OTHER||Ratio (Active Vs Placebo)|1.19|||||TWO_SIDED|90.0|1.11|1.27||||||||1.27|1.11|
72415474|NCT02512575|144341668|SUPERIORITY_OR_OTHER||Ratio (Active Vs Placebo)|1.05|||||TWO_SIDED|90.0|0.872|1.26||||||||1.26|0.872|
72415475|NCT02512575|144341668|SUPERIORITY_OR_OTHER||Ratio (Active Vs Placebo)|1.05|||||TWO_SIDED|90.0|0.874|1.26||||||||1.26|0.874|
72415476|NCT02512575|144341668|SUPERIORITY_OR_OTHER||Ratio (Active Vs Placebo)|0.907|||||TWO_SIDED|90.0|0.745|1.1||||||||1.10|0.745|
72415477|NCT02512575|144341668|SUPERIORITY_OR_OTHER||Ratio (Active Vs Placebo)|0.914|||||TWO_SIDED|90.0|0.762|1.1||||||||1.10|0.762|
72415478|NCT02512575|144341668|SUPERIORITY_OR_OTHER||Ratio (Active Vs Placebo)|0.876|||||TWO_SIDED|90.0|0.728|1.05||||||||1.05|0.728|
72415479|NCT02512575|144341668|SUPERIORITY_OR_OTHER||Ratio (Active Vs Placebo)|0.86|||||TWO_SIDED|90.0|0.716|1.03||||||||1.03|0.716|
72415480|NCT02512575|144341668|SUPERIORITY_OR_OTHER||Ratio (Active Vs Placebo)|1.01|||||TWO_SIDED|90.0|0.842|1.21||||||||1.21|0.842|
72415481|NCT02512575|144341668|SUPERIORITY_OR_OTHER||Ratio (Active Vs Placebo)|1.02|||||TWO_SIDED|90.0|0.846|1.22||||||||1.22|0.846|
72415482|NCT02512575|144341668|SUPERIORITY_OR_OTHER||Ratio (Active Vs Placebo)|0.687|||||TWO_SIDED|90.0|0.572|0.825||||||||0.825|0.572|
72415483|NCT02512575|144341669|SUPERIORITY_OR_OTHER||Ratio (Active Vs Placebo)|0.982|||||TWO_SIDED|90.0|0.861|1.12||||||||1.12|0.861|
72415484|NCT02512575|144341669|SUPERIORITY_OR_OTHER||Ratio (Active Vs Placebo)|0.961||||||90.0|0.846|1.09||||||||1.09|0.846|
72415485|NCT02512575|144341669|SUPERIORITY_OR_OTHER||Ratio (Active Vs Placebo)|0.942|||||TWO_SIDED|90.0|0.829|1.07||||||||1.07|0.829|
72415486|NCT02512575|144341669|SUPERIORITY_OR_OTHER||Ratio (Active Vs Placebo)|0.861|||||TWO_SIDED|90.0|0.757|0.979||||||||0.979|0.757|
72415487|NCT02512575|144341669|SUPERIORITY_OR_OTHER||Ratio (Active Vs Placebo)|0.848|||||TWO_SIDED|90.0|0.745|0.964||||||||0.964|0.745|
72415488|NCT02512575|144341669|SUPERIORITY_OR_OTHER||Ratio (Active Vs Placebo)|0.927|||||TWO_SIDED|90.0|0.815|1.05||||||||1.05|0.815|
72415489|NCT02512575|144341669|SUPERIORITY_OR_OTHER||Ratio (Active Vs Placebo)|0.907|||||TWO_SIDED|90.0|0.798|1.03||||||||1.03|0.798|
72415490|NCT02512575|144341669|SUPERIORITY_OR_OTHER||Ratio (Active Vs Placebo)|0.893|||||TWO_SIDED|90.0|0.784|1.02||||||||1.02|0.784|
72415491|NCT02512575|144341669|SUPERIORITY_OR_OTHER||Ratio (Active Vs Placebo)|0.691||||||90.0|0.608|0.785||||||||0.785|0.608|
72415492|NCT01022762|144341677|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority would be shown if the upper limit of the 95% confidence interval was less than 0.4%. This corresponds to a one-sided test with a significance level of 2.5% of the hypothesis.|Mean Difference (Net)|0.014|STANDARD_ERROR_OF_MEAN|0.066||||95.0|-0.115|0.143||The p-value corresponds to one-sided hypotheses of superiority with a significance level of 2.5%.|ANCOVA|ANCOVA model was with treatment, centre as explanatory variables and baseline HbA1c value as covariate.|If non-inferiority of repaglinide alone was shown, a test for superiority would be performed based on FAS. Superiority of repaglinide alone over gliclazide alone would be claimed if the upper limit of the 95% CI for the difference was lower than 0%.|H0: Change from baseline in HbA1c of repaglinide therapy at 16 weeks of treatment - change from baseline in HbA1c of gliclazide therapy at 16 weeks of treatment \>= 0.4%. H1: Change from baseline in HbA1c of repaglinide therapy at 16 weeks of treatment - change from baseline in HbA1c of gliclazide therapy at 16 weeks of treatment \< 0.4%. Sample size was calculated to achieve a power of at least 85%, assuming an equal change in HbA1c and a common standard deviation of 1.2%.||0.143|-0.115|
72415493|NCT00435370|144341688|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||ANCOVA|||||||<0.05
72415494|NCT00617344|144341720|OTHER|The associated 95% confidence intervals (CIs) for the point estimates and the differences were calculated using normal approximation.|Difference in Percentage|-2.0|||||TWO_SIDED|95.0|-7.44|2.84||||||Dengue Virus Serotype 1: Pre-injection 1 (Day 0)||2.84|-7.44|
72415495|NCT00617344|144341720|OTHER|The associated 95% CIs for the point estimates and the differences were calculated using normal approximation.|Difference in Percentage|-15.5|||||TWO_SIDED|95.0|-28.4|-2.0||||||Dengue Virus Serotype 1: 30 days post-injection 2||-2.00|-28.4|
72415496|NCT00617344|144341720|OTHER|The associated 95% CIs for the point estimates and the differences were calculated using normal approximation.|Difference in Percentage|-2.0|||||TWO_SIDED|95.0|-7.44|2.84||||||Dengue Virus Serotype 2: Pre-injection 1 (Day 0)||2.84|-7.44|
72415497|NCT00617344|144341720|OTHER|The associated 95% CIs for the point estimates and the differences were calculated using normal approximation.|Difference in Percentage|-3.1|||||TWO_SIDED|95.0|-15.0|8.75||||||Dengue Virus Serotype 2: 30 days post-injection 2||8.75|-15.0|
72596493|NCT02440854|144724291|OTHER||||||<|0.001|||||||t-test, 2 sided|Paired t-test.||Baseline vs 18-month post-baseline.||||<0.001
72596494|NCT02440854|144724291|OTHER||||||<|0.001|||||||t-test, 2 sided|Paired t-test.||Baseline vs 24-month post-baseline.||||<0.001
72596495|NCT02440854|144724291|OTHER||||||<|0.001|||||||t-test, 2 sided|Paired t-test.||Baseline vs 30-month post-baseline.||||<0.001
72596496|NCT02440854|144724291|OTHER|||||||0.002|||||||t-test, 2 sided|Paired t-test||Baseline vs 36-month post-baseline.||||0.002
72596497|NCT02440854|144724292|OTHER|||||||0.022|||||||t-test, 2 sided|Paired t-test.||Baseline vs 2-month post-baseline.||||0.022
72596498|NCT02440854|144724292|OTHER||||||<|0.001|||||||t-test, 2 sided|Paired t-test.||Baseline vs 4-month post-baseline.||||<0.001
72596499|NCT02440854|144724292|OTHER|||||||0.004|||||||t-test, 2 sided|Paired t-test.||Baseline vs 6-month post-baseline.||||0.004
72596500|NCT02440854|144724292|OTHER|||||||0.032|||||||t-test, 2 sided|Paired t-test.||Baseline vs 8-month post-baseline.||||0.032
72596501|NCT02440854|144724292|OTHER|||||||0.066|||||||t-test, 2 sided|Paired t-test.||Baseline vs 10-month post-baseline.||||0.066
72415498|NCT00617344|144341720|OTHER|The associated 95% CIs for the point estimates and the differences were calculated using normal approximation.|Difference in Percentage|1.0|||||TWO_SIDED|95.0|-9.09|11.1||||||Dengue Virus Serotype 3: Pre-injection 1 (Day 0)||11.1|-9.09|
72415499|NCT00617344|144341720|OTHER|The associated 95% CIs for the point estimates and the differences were calculated using normal approximation.|Difference in Percentage|-5.7|||||TWO_SIDED|95.0|-15.6|3.81||||||Dengue Virus Serotype 3: 30 days post-injection 2||3.81|-15.6|
72596502|NCT02440854|144724292|OTHER|||||||0.042|||||||t-test, 2 sided|Paired t-test.||Baseline vs 12-month post-baseline.||||0.042
72596503|NCT02440854|144724292|OTHER|||||||0.045|||||||t-test, 2 sided|Paired t-test.||Baseline vs 18-month post-baseline.||||0.045
72596504|NCT02440854|144724292|OTHER|||||||0.014|||||||t-test, 2 sided|Paired t-test.||Baseline vs 24-month post-baseline.||||0.014
72596505|NCT02440854|144724292|OTHER|||||||0.015|||||||t-test, 2 sided|Paired t-test.||Baseline vs 30-month post-baseline.||||0.015
72596506|NCT02440854|144724292|OTHER|||||||0.462|||||||t-test, 2 sided|Paired t-test||Baseline vs 36-month post-baseline.||||0.462
72596507|NCT02440854|144724293|OTHER||||||<|0.001|||||||t-test, 2 sided|Paired t-test.||Baseline vs 2-month post-baseline.||||<0.001
72596508|NCT02440854|144724293|OTHER|||||||0.004|||||||t-test, 2 sided|Paired t-test.||Baseline vs 4-month post-baseline.||||0.004
72596509|NCT02440854|144724293|OTHER|||||||0.008|||||||t-test, 2 sided|Paired t-test.||Baseline vs 6-month post-baseline.||||0.008
72596510|NCT02440854|144724293|OTHER|||||||0.315|||||||t-test, 2 sided|Paired t-test.||Baseline vs 8-month post-baseline.||||0.315
72596511|NCT02440854|144724293|OTHER|||||||0.237|||||||t-test, 2 sided|Paired t-test.||Baseline vs 10-month post-baseline.||||0.237
72596512|NCT02440854|144724293|OTHER||||||<|0.001|||||||t-test, 2 sided|Paired t-test.||Baseline vs 12-month post-baseline.||||<0.001
72596513|NCT02440854|144724293|OTHER|||||||0.002|||||||t-test, 2 sided|Paired t-test.||Baseline vs 18-month post-baseline.||||0.002
72596514|NCT02440854|144724293|OTHER|||||||0.004|||||||t-test, 2 sided|Paired t-test.||Baseline vs 24-month post-baseline.||||0.004
72596515|NCT02440854|144724293|OTHER|||||||0.01|||||||t-test, 2 sided|Paired t-test.||Baseline vs 30-month post-baseline.||||0.010
72596516|NCT02440854|144724293|OTHER|||||||0.683|||||||t-test, 2 sided|Paired t-test||Baseline vs 36-month post-baseline.||||0.683
72596517|NCT02440854|144724294|OTHER|||||||0.062|||||||t-test, 2 sided|Paired t-test.||Baseline vs 2-month post-baseline.||||0.062
72596518|NCT02440854|144724294|OTHER|||||||0.062|||||||t-test, 2 sided|Paired t-test.||Baseline vs 4-month post-baseline.||||0.062
72596519|NCT02440854|144724294|OTHER|||||||0.027|||||||t-test, 2 sided|Paired t-test.||Baseline vs 6-month post-baseline.||||0.027
72596520|NCT02440854|144724294|OTHER|||||||0.17|||||||t-test, 2 sided|Paired t-test.||Baseline vs 8-month post-baseline.||||0.170
72596521|NCT02440854|144724294|OTHER|||||||0.271|||||||t-test, 2 sided|Paired t-test.||Baseline vs 10-month post-baseline.||||0.271
72596522|NCT02440854|144724294|OTHER|||||||0.002|||||||t-test, 2 sided|Paired t-test.||Baseline vs 12-month post-baseline.||||0.002
72596523|NCT02440854|144724294|OTHER|||||||0.003|||||||t-test, 2 sided|Paired t-test.||Baseline vs 18-month post-baseline.||||0.003
72596524|NCT02440854|144724294|OTHER|||||||0.157|||||||t-test, 2 sided|Paired t-test.||Baseline vs 24-month post-baseline.||||0.157
72596525|NCT02440854|144724294|OTHER|||||||0.064|||||||t-test, 2 sided|Paired t-test.||Baseline vs 30-month post-baseline.||||0.064
72596526|NCT02440854|144724294|OTHER|||||||0.439|||||||t-test, 2 sided|Paired t-test||Baseline vs 36-month post-baseline.||||0.439
72596527|NCT02440854|144724295|OTHER|||||||0.388|||||||McNemar|||Shift in patient distribution between baseline and Month 2 post-baseline, according to problems/no problems.||||0.388
72596528|NCT02440854|144724295|OTHER|||||||0.006|||||||McNemar|||Shift in patient distribution between baseline and Month 4 post-baseline, according to problems/no problems.||||0.006
72596529|NCT02440854|144724295|OTHER|||||||0.077|||||||McNemar|||Shift in patient distribution between baseline and Month 6 post-baseline, according to problems/no problems.||||0.077
72596530|NCT02440854|144724295|OTHER||||||>|0.999|||||||McNemar|||Shift in patient distribution between baseline and Month 8 post-baseline, according to problems/no problems.||||>0.999
72596531|NCT02440854|144724295|OTHER|||||||0.508|||||||McNemar|||Shift in patient distribution between baseline and Month 10 post-baseline, according to problems/no problems.||||0.508
72596532|NCT02440854|144724295|OTHER||||||>|0.999|||||||McNemar|||Shift in patient distribution between baseline and Month 12 post-baseline, according to problems/no problems.||||>0.999
72596533|NCT02440854|144724295|OTHER||||||>|0.999|||||||McNemar|||Shift in patient distribution between baseline and Month 18 post-baseline, according to problems/no problems.||||>0.999
72596534|NCT02440854|144724295|OTHER||||||>|0.999|||||||McNemar|||Shift in patient distribution between baseline and Month 24 post-baseline, according to problems/no problems.||||>0.999
72596535|NCT02440854|144724295|OTHER||||||>|0.999|||||||McNemar|||Shift in patient distribution between baseline and Month 30 post-baseline, according to problems/no problems.||||>0.999
72596536|NCT02440854|144724295|OTHER||||||>|0.999|||||||McNemar|||Shift in patient distribution between baseline and Month 36 post-baseline, according to problems/no problems.||||>0.999
72596537|NCT02440854|144724296|OTHER||||||>|0.999|||||||McNemar|||Shift in patient distribution between baseline and Month 2 post-baseline, according to problems/no problems.||||>0.999
72596538|NCT02440854|144724296|OTHER||||||>|0.999|||||||McNemar|||Shift in patient distribution between baseline and Month 4 post-baseline, according to problems/no problems.||||>0.999
72596539|NCT02440854|144724296|OTHER||||||>|0.999|||||||McNemar|||Shift in patient distribution between baseline and Month 6 post-baseline, according to problems/no problems.||||>0.999
72596540|NCT02440854|144724296|OTHER||||||>|0.999|||||||McNemar|||Shift in patient distribution between baseline and Month 8 post-baseline, according to problems/no problems.||||>0.999
72596541|NCT02440854|144724296|OTHER||||||>|0.999|||||||McNemar|||Shift in patient distribution between baseline and Month 10 post-baseline, according to problems/no problems.||||>0.999
72596542|NCT02440854|144724296|OTHER||||||>|0.999|||||||McNemar|||Shift in patient distribution between baseline and Month 12 post-baseline, according to problems/no problems.||||>0.999
72596543|NCT02440854|144724296|OTHER||||||>|0.999|||||||McNemar|||Shift in patient distribution between baseline and Month 18 post-baseline, according to problems/no problems.||||>0.999
72596544|NCT02440854|144724297|OTHER|||||||0.774|||||||McNemar|||Shift in patient distribution between baseline and Month 2 post-baseline, according to problems/no problems.||||0.774
72596545|NCT02440854|144724297|OTHER||||||>|0.999|||||||McNemar|||Shift in patient distribution between baseline and Month 4 post-baseline, according to problems/no problems.||||>0.999
72596546|NCT02440854|144724297|OTHER|||||||0.607|||||||McNemar|||Shift in patient distribution between baseline and Month 6 post-baseline, according to problems/no problems.||||0.607
72596547|NCT02440854|144724297|OTHER|||||||0.774|||||||McNemar|||Shift in patient distribution between baseline and Month 8 post-baseline, according to problems/no problems.||||0.774
72596548|NCT02440854|144724297|OTHER||||||>|0.999|||||||McNemar|||Shift in patient distribution between baseline and Month 10 post-baseline, according to problems/no problems.||||>0.999
72596549|NCT02440854|144724297|OTHER|||||||0.453|||||||McNemar|||Shift in patient distribution between baseline and Month 12 post-baseline, according to problems/no problems.||||0.453
72596550|NCT02440854|144724297|OTHER|||||||0.688|||||||McNemar|||Shift in patient distribution between baseline and Month 18 post-baseline, according to problems/no problems.||||0.688
72596551|NCT02440854|144724297|OTHER||||||>|0.999|||||||McNemar|||Shift in patient distribution between baseline and Month 24 post-baseline, according to problems/no problems.||||>0.999
72596552|NCT02440854|144724297|OTHER|||||||0.25|||||||McNemar|||Shift in patient distribution between baseline and Month 30 post-baseline, according to problems/no problems.||||0.250
72596553|NCT02440854|144724297|OTHER||||||>|0.999|||||||McNemar|||Shift in patient distribution between baseline and Month 36 post-baseline, according to problems/no problems.||||>0.999
72596554|NCT02440854|144724298|OTHER|||||||0.077|||||||McNemar|||Shift in patient distribution between baseline and Month 2 post-baseline, according to problems/no problems.||||0.077
72596555|NCT02440854|144724298|OTHER||||||<|0.001|||||||McNemar|||Shift in patient distribution between baseline and Month 4 post-baseline, according to problems/no problems.||||<0.001
72596556|NCT02440854|144724298|OTHER|||||||0.006|||||||McNemar|||Shift in patient distribution between baseline and Month 6 post-baseline, according to problems/no problems.||||0.006
72596557|NCT02440854|144724298|OTHER|||||||0.344|||||||McNemar|||Shift in patient distribution between baseline and Month 8 post-baseline, according to problems/no problems.||||0.344
72596558|NCT02440854|144724298|OTHER|||||||0.146|||||||McNemar|||Shift in patient distribution between baseline and Month 10 post-baseline, according to problems/no problems.||||0.146
72596559|NCT02440854|144724298|OTHER|||||||0.18|||||||McNemar|||Shift in patient distribution between baseline and Month 12 post-baseline, according to problems/no problems.||||0.180
72596560|NCT02440854|144724298|OTHER|||||||0.289|||||||McNemar|||Shift in patient distribution between baseline and Month 18 post-baseline, according to problems/no problems.||||0.289
72596561|NCT02440854|144724298|OTHER|||||||0.125|||||||McNemar|||Shift in patient distribution between baseline and Month 24 post-baseline, according to problems/no problems.||||0.125
72415500|NCT00617344|144341720|OTHER|The associated 95% CIs for the point estimates and the differences were calculated using normal approximation.|Difference in Percentage|-4.0|||||TWO_SIDED|95.0|-10.9|2.49||||||Dengue Virus Serotype 4: Pre-injection 1 (Day 0)||2.49|-10.9|
72415501|NCT00617344|144341720|OTHER|The associated 95% CIs for the point estimates and the differences were calculated using normal approximation.|Difference in Percentage|31.4|||||TWO_SIDED|95.0|18.2|43.2||||||Dengue Virus Serotype 4: 30 days post-injection 2||43.2|18.2|
72415502|NCT02298192|144341727|NON_INFERIORITY_OR_EQUIVALENCE|The null hypothesis was tested against the alternative hypothesis of non-inferiority as given by H0: D ≥0.30% against HA: D \<0.30%.|Treatment Contrast|0.12||||0.012|TWO_SIDED|95.0|-0.04|0.28|||Mixed Models Analysis|||The null hypothesis was tested against the alternative hypothesis of non-inferiority as given by H0: D ≥0.30% against HA: D \<0.30%.||0.28|-0.04|0.012
72415503|NCT00127608|144341838|NON_INFERIORITY|The mean viral load between samples stored in liquid and samples stored dry was compared.|Geometric Mean Ratio|0.33|||<|0.0001|||||||ANOVA|Tukey adjustments were made for all 2 by 2 comparisons.|The Geometric Mean Ratio of the viral load was calculated for dry over liquid storage condition.|||||<0.0001
72415504|NCT00127608|144341839|NON_INFERIORITY_OR_EQUIVALENCE|Difference in mean viral load (in log10) (Papule swab minus Vesicle fluid)|Mean Difference (Final Values)|-0.4451||||0.0038||95.0|-0.769|-0.1213|||ANOVA|Tukey adjustments were made for the comparison.||||-0.1213|-0.7690|0.0038
72415505|NCT00127608|144341839|NON_INFERIORITY_OR_EQUIVALENCE|Difference in mean viral load (in log10) (Papule swab minus Vesicle swab)|Median Difference (Final Values)|-0.432||||0.006|TWO_SIDED|95.0|-0.7605|-0.1035|||ANOVA|Tukey adjustments were made for the comparison.||||-0.1035|-0.7605|0.0060
72415506|NCT00127608|144341839|NON_INFERIORITY_OR_EQUIVALENCE|Difference in mean viral load (in log10) (Vesicle fluid minus Vesicle swab)|Mean Difference (Final Values)|0.00132||||0.9952|TWO_SIDED|95.0|-0.3171|0.3435|||ANOVA|Tukey adjustments were made for the comparison.||||0.3435|-0.3171|0.9952
72415507|NCT00127608|144341839|NON_INFERIORITY_OR_EQUIVALENCE|Geometric mean ratio of viral load (Papule swab over Vesicle fluid)|Geometric mean ratio|0.36|||||TWO_SIDED|95.0|0.17|0.76|||ANOVA|||Geometric mean ratio of viral load (Papule swab over Vesicle fluid)||0.76|0.17|
72415508|NCT00127608|144341839|NON_INFERIORITY_OR_EQUIVALENCE|Geometric mean ratio of viral load (Papule swab over Vesicle swab)|Geometric mean Ratio|0.37|||||TWO_SIDED|95.0|0.17|0.79|||ANOVA|||Geometric mean ratio of viral load (Papule swab over Vesicle swab)||0.79|0.17|
72415509|NCT00127608|144341839|NON_INFERIORITY_OR_EQUIVALENCE|Geometric mean ratio of viral load (Vesicle fluid over Vesicle swab)|Geometric mean Ratio|1.0|||||TWO_SIDED|95.0|0.48|2.21|||ANOVA|||Geometric mean ratio of viral load (Vesicle fluid over Vesicle swab)||2.21|0.48|
72415510|NCT01329029|144341840|SUPERIORITY_OR_OTHER||Rate ratio|0.868|STANDARD_ERROR_OF_MEAN|0.0633||0.0529|TWO_SIDED|95.0|0.753|1.002||Level of significance: 5% 2-sided|Generalized Linear Regression|Poisson regression model (estimates of exacerbation rates using time in trial as model offset).|A rate ratio of \< 1 represents a favourable outcome for the test treatment.|||1.002|0.753|0.0529
72415511|NCT01329029|144341841|SUPERIORITY_OR_OTHER||LS Mean difference|0.056|STANDARD_ERROR_OF_MEAN|0.0089|<|0.0001|TWO_SIDED|95.0|0.038|0.073|||ANCOVA|Analysis of Covariance (ANCOVA) including treatment by time interaction.||||0.073|0.038|<0.0001
72415512|NCT01329029|144341842|SUPERIORITY_OR_OTHER||Rate ratio|0.757|STANDARD_ERROR_OF_MEAN|0.0889||0.0175|TWO_SIDED|95.0|0.601|0.952|||Generalized Linear Regression|Analyzed using a negative binomial regression model excluding a correction for overdispersion.|A rate ratio of \< 1 represents a favourable outcome for the test treatment.|||0.952|0.601|0.0175
72415513|NCT01329029|144341843|SUPERIORITY_OR_OTHER||Rate ratio|0.914|STANDARD_ERROR_OF_MEAN|0.0771||0.2875|TWO_SIDED|95.0|0.775|1.078||Level of significance: 5% 2-sided|Generalized Linear Regression|Poisson regression model (estimates of exacerbation rates using time in trial as model offset).|A rate ratio of \< 1 represents a favourable outcome for the test treatment.|Moderate COPD Exacerbations||1.078|0.775|0.2875
72596562|NCT02440854|144724298|OTHER||||||>|0.999|||||||McNemar|||Shift in patient distribution between baseline and Month 30 post-baseline, according to problems/no problems.||||>0.999
72596563|NCT02440854|144724298|OTHER|||||||0.5|||||||McNemar|||Shift in patient distribution between baseline and Month 36 post-baseline, according to problems/no problems.||||0.500
72596564|NCT02440854|144724299|OTHER|||||||0.21|||||||McNemar|||Shift in patient distribution between baseline and Month 2 post-baseline, according to problems/no problems.||||0.210
72596565|NCT02440854|144724299|OTHER|||||||0.263|||||||McNemar|||Shift in patient distribution between baseline and Month 4 post-baseline, according to problems/no problems.||||0.263
72596566|NCT02440854|144724299|OTHER||||||>|0.999|||||||McNemar|||Shift in patient distribution between baseline and Month 6 post-baseline, according to problems/no problems.||||>0.999
72596567|NCT02440854|144724299|OTHER||||||>|0.999|||||||McNemar|||Shift in patient distribution between baseline and Month 8 post-baseline, according to problems/no problems.||||>0.999
72596568|NCT02440854|144724299|OTHER|||||||0.629|||||||McNemar|||Shift in patient distribution between baseline and Month 10 post-baseline, according to problems/no problems.||||0.629
72596569|NCT02440854|144724299|OTHER||||||>|0.999|||||||McNemar|||Shift in patient distribution between baseline and Month 12 post-baseline, according to problems/no problems.||||>0.999
72596570|NCT02440854|144724299|OTHER||||||>|0.999|||||||McNemar|||Shift in patient distribution between baseline and Month 18 post-baseline, according to problems/no problems.||||>0.999
72415514|NCT01329029|144341843|SUPERIORITY_OR_OTHER||Rate Ratio|0.794|STANDARD_ERROR_OF_MEAN|0.0654||0.005|TWO_SIDED|95.0|0.675|0.933||Level of significance: 5% 2-sided|Generalized Linear Regression|Poisson regression model (estimates of exacerbation rates using time in trial as model offset).|A rate ratio of \< 1 represents a favourable outcome for the test treatment.|Mild, Moderate or Severe COPD Exacerbations||0.933|0.675|0.0050
72596571|NCT02440854|144724299|OTHER||||||>|0.999|||||||McNemar|||Shift in patient distribution between baseline and Month 24 post-baseline, according to problems/no problems.||||>0.999
72596572|NCT02440854|144724299|OTHER||||||>|0.999|||||||McNemar|||Shift in patient distribution between baseline and Month 30 post-baseline, according to problems/no problems.||||>0.999
72596573|NCT02440854|144724299|OTHER||||||>|0.999|||||||McNemar|||Shift in patient distribution between baseline and Month 36 post-baseline, according to problems/no problems.||||>0.999
72596574|NCT02440854|144724300|OTHER|||||||0.098|||||||Wilcoxon (Mann-Whitney)|||Baseline vs 2-month post-baseline.||||0.098
72596575|NCT02440854|144724300|OTHER|||||||0.359|||||||Wilcoxon (Mann-Whitney)|||Baseline vs 4-month post-baseline.||||0.359
72596576|NCT02440854|144724300|OTHER|||||||0.393|||||||Wilcoxon (Mann-Whitney)|||Baseline vs 6-month post-baseline.||||0.393
72596577|NCT02440854|144724300|OTHER|||||||0.055|||||||Wilcoxon (Mann-Whitney)|||Baseline vs 8-month post-baseline.||||0.055
72596578|NCT02440854|144724300|OTHER|||||||0.124|||||||Wilcoxon (Mann-Whitney)|||Baseline vs 10-month post-baseline.||||0.124
72596579|NCT02440854|144724300|OTHER|||||||0.376|||||||Wilcoxon (Mann-Whitney)|||Baseline vs 12-month post-baseline.||||0.376
72596580|NCT02440854|144724300|OTHER|||||||0.033|||||||Wilcoxon (Mann-Whitney)|||Baseline vs 18-month post-baseline.||||0.033
72596581|NCT02440854|144724300|OTHER|||||||0.048|||||||Wilcoxon (Mann-Whitney)|||Baseline vs 24-month post-baseline.||||0.048
72596582|NCT02440854|144724300|OTHER|||||||0.071|||||||Wilcoxon (Mann-Whitney)|||Baseline vs 30-month post-baseline.||||0.071
72596583|NCT02440854|144724300|OTHER|||||||0.848|||||||Wilcoxon (Mann-Whitney)|||Baseline vs 36-month post-baseline.||||0.848
72596584|NCT02243046|144724325|SUPERIORITY_OR_OTHER|||||||0.091|||||||ANOVA|||The null hypothesis states that there is no difference between groups.||||0.091
72596585|NCT02243046|144724326|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||<0.001
72596586|NCT02243046|144724327|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||The null hypothesis states that there is no difference between groups||||< 0.001
72596587|NCT02243046|144724328|SUPERIORITY_OR_OTHER|||||||0.571|||||||ANOVA|||The null hypothesis states that there is no difference between groups||||0.571
72596588|NCT02243046|144724329|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANCOVA|||The null hypothesis states that there is no difference between groups||||< 0.001
72596589|NCT02243046|144724330|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANCOVA|||The null hypothesis states that there is no difference between groups||||< 0.001
72596590|NCT02669082|144724331|OTHER|||||||0.2955|||||||t-test, 2 sided|||Data at Baseline compared to the data at the end of the Treatment Period.||||0.2955
72596591|NCT02669082|144724332|OTHER|||||||0.1358|||||||t-test, 2 sided|||Data at Baseline compared to the data at the end of the Treatment Period.||||0.1358
72596592|NCT02669082|144724333|OTHER||Median|||||0.1706|||||||t-test, 2 sided|||Data at Baseline compared to the data at the end of the Treatment Period.||||0.1706
72596593|NCT02669082|144724334|OTHER|||||||0.1969|||||||t-test, 2 sided|||Data at Baseline compared to the data at the end of the Treatment Period.||||0.1969
72596594|NCT02669082|144724335|OTHER|||||||0.0534|||||||t-test, 2 sided|||Data at Baseline compared to the data at the end of the Treatment Period.||||0.0534
72596595|NCT02669082|144724336|OTHER|||||||0.4125|||||||t-test, 2 sided|||Data at Baseline compared to the data at the end of the Treatment Period.||||0.4125
72596596|NCT02669082|144724337|OTHER|||||||0.022|||||||t-test, 2 sided|||Data at Baseline compared to the data at the end of the Treatment Period.||||0.0220
72415515|NCT01329029|144341843|SUPERIORITY_OR_OTHER||Rate ratio|0.854|STANDARD_ERROR_OF_MEAN|0.0605||0.0262|TWO_SIDED|95.0|0.744|0.982||Level of significance: 5% 2-sided|Generalized Linear Regression|Poisson regression model (estimates of exacerbation rates using time in trial as model offset).|A rate ratio of \< 1 represents a favourable outcome for the test treatment.|COPD Exacerbations treated with Glucocorticosteroids and/or Antibiotics||0.982|0.744|0.0262
72415516|NCT01329029|144341843|SUPERIORITY_OR_OTHER||Rate ratio|0.837|STANDARD_ERROR_OF_MEAN|0.0528||0.0047|TWO_SIDED|95.0|0.739|0.947||Level of significance: 5% 2-sided|Generalized Linear Regression|Poisson regression model (estimates of exacerbation rates using time in trial as model offset).|A rate ratio of \< 1 represents a favourable outcome for the test treatment.|Moderate or Severe COPD Exacerbations and/or treated with Antibiotics||0.947|0.739|0.0047
72415517|NCT01329029|144341843|SUPERIORITY_OR_OTHER||Rate ratio|0.761|STANDARD_ERROR_OF_MEAN|0.0899||0.0209|TWO_SIDED|95.0|0.604|0.96||Level of significance: 5% 2-sided.|Generalized Linear Regression|Negative binomial regression model (estimates of exacerbation rates)|A rate ratio of \< 1 represents a favourable outcome for the test treatment.|Leading to Hospitalisation||0.960|0.604|0.0209
72415518|NCT01329029|144341845|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.917|STANDARD_ERROR_OF_MEAN|0.0549||0.1461|TWO_SIDED|95.0|0.815|1.031||Level of significance: 5% 2-sided.|Cox proportional hazards model||A hazards ratio of \< 1 represents a lower hazard for the test treatment.|||1.031|0.815|0.1461
72415519|NCT01329029|144341846|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.79|STANDARD_ERROR_OF_MEAN|0.0842||0.027|TWO_SIDED|95.0|0.641|0.974||Level of significance: 5% 2-sided|Wei-Lin-Weissfeld Method||A hazard ratio of \<1 represents a favourable outcome for the test treatment|||0.974|0.641|0.0270
72415520|NCT01329029|144341847|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.749|STANDARD_ERROR_OF_MEAN|0.1209||0.0731|TWO_SIDED|95.0|0.546|1.027||Level of significance: 5% 2-sided|Wei-Lin-Weissfeld Method||A hazard ratio of \<1 represents a favourable outcome for the test treatment.|||1.027|0.546|0.0731
72415521|NCT01329029|144341848|SUPERIORITY_OR_OTHER||NNTB|9.0|||||TWO_SIDED|95.0|4.0|31.0||||||||31|4|
72415522|NCT01329029|144341851|SUPERIORITY_OR_OTHER||Least Square Mean Difference|0.092|STANDARD_ERROR_OF_MEAN|0.0159|<|0.0001|TWO_SIDED|95.0|0.061|0.124||Level of significance: 5% 2-sided.|Repeated measurement model|Unstructured covariance structure and restricted maximum likelihood (REML).||||0.124|0.061|<0.0001
72415523|NCT01329029|144341852|SUPERIORITY_OR_OTHER||Least Square Mean Difference|0.025|STANDARD_ERROR_OF_MEAN|0.0062|<|0.0001|TWO_SIDED|95.0|0.013|0.038||Level of significance: 5% 2-sided.|Repeated measurement model|Unstructured covariance structure and REML.||||0.038|0.013|<0.0001
72415524|NCT01329029|144341853|SUPERIORITY_OR_OTHER||Least Square Mean Difference|0.094|STANDARD_ERROR_OF_MEAN|0.0131|<|0.0001|TWO_SIDED|95.0|0.069|0.12||Level of significance: 5% 2-sided.|Repeated measurement model|Unstructured covariance structure and REML.||||0.120|0.069|<0.0001
72415525|NCT01329029|144341855|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-0.283|STANDARD_ERROR_OF_MEAN|0.0941||0.0027|TWO_SIDED|95.0|-0.467|-0.098||Level of significance: 5% 2-sided.|Repeated measurement model|Compound symmetry covariance structure and REML.||||-0.098|-0.467|0.0027
72415526|NCT01329029|144341856|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-0.015|STANDARD_ERROR_OF_MEAN|0.0439||0.7392|TWO_SIDED|95.0|-0.101|0.071||Level of significance: 5% 2-sided.|Repeated measurement model|Compound symmetry covariance structure and REML.||||0.071|-0.101|0.7392
72415527|NCT01329029|144341859|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-0.285|STANDARD_ERROR_OF_MEAN|0.2175||0.1909|TWO_SIDED|95.0|-0.711|0.142||Level of significance: 5% 2-sided.|Repeated measurement model|Unstructured covariance structure and REML.||||0.142|-0.711|0.1909
72415528|NCT01329029|144341861|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.025|STANDARD_ERROR_OF_MEAN|0.3468||0.9414|TWO_SIDED|95.0|0.528|1.99||Level of significance: 5% 2-sided.|Cox-proportional hazards model||A hazards ratio of \< 1 represents a lower hazard for the test treatment.|||1.990|0.528|0.9414
72415529|NCT01329029|144341862|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.078|STANDARD_ERROR_OF_MEAN|0.5765||0.8876|TWO_SIDED|95.0|0.378|3.075|||Cox-proportional hazards model|Level of significance: 5% 2-sided.|A hazards ratio of \< 1 represents a lower hazard for the test treatment.|||3.075|0.378|0.8876
72415530|NCT01329029|144341863|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.529|STANDARD_ERROR_OF_MEAN|0.1463|<|0.0001|TWO_SIDED|95.0|1.268|1.845|||Cox-proportional hazards model|Level of significance: 5% 2-sided.|A hazards ratio of \< 1 represents a lower hazard for the test treatment.|||1.845|1.268|<0.0001
72415531|NCT01329029|144341864|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.695|STANDARD_ERROR_OF_MEAN|0.2691||0.3477|TWO_SIDED|95.0|0.326|1.484||Level of significance: 5% 2-sided.|Cox-proportional hazards model||A hazards ratio of \< 1 represents a lower hazard for the test treatment.|||1.484|0.326|0.3477
72596597|NCT02669082|144724338|OTHER|||||||0.042|||||||t-test, 2 sided|||Data at Baseline compared to the data at the end of the Treatment Period.||||0.0420
72596598|NCT02669082|144724339|OTHER|||||||0.8166|||||||t-test, 2 sided|||Data at Baseline compared to the data at the end of the Treatment Period.||||0.8166
72596599|NCT02509078|144724387|SUPERIORITY||Risk Difference (RD)|-0.3||||0.93|TWO_SIDED|95.0|-6.4|5.9|||Wald test for the difference of two prop||Estimated value is a percentage|||5.9|-6.4|0.93
72596600|NCT02603107|144724432|NON_INFERIORITY|A sample size of 520 participants (260 participants per treatment group) would provide at least 90% power to establish a non-inferiority margin of 4% in the Week 48 response rate (HIV-1 RNA ≥ 50 copies/mL) between the 2 treatment groups. Sample size was based on the assumptions that both treatment groups have 2% of participants with HIV-1 RNA ≥ 50 copies/mL (based on Gilead Genvoya and Stribild studies) and that the significance level of the test is at a 1-sided 0.025 level.|Difference in Percentages|0.0|||||TWO_SIDED|95.002|-2.5|2.5|||||The difference in percentages and its 95.002% confidence interval (CI) were calculated based on an unconditional exact method using 2 inverted 1-sided tests.|The null hypothesis was that the percentage of participants with HIV-1 RNA ≥ 50 copies/mL at Week 48 in the B/F/TAF group was at least 4% higher than the rate in the SBR group; the alternative hypothesis was that the percentage of participants with HIV-1 RNA ≥ 50 copies/mL in the B/F/TAF group was less than 4% higher than that in the SBR group.||2.5|-2.5|
72596601|NCT02603107|144724432|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.00
72596602|NCT02603107|144724433|NON_INFERIORITY|The non-inferiority of B/F/TAF would be established if the lower bound of the 2-sided 95.002% CI of the difference between the treatment groups (B/F/TAF group - SBR group) in the percentage of participants with HIV-1 RNA \< 50 copies/mL is greater than -10%.|Difference in Percentages|3.2|||||TWO_SIDED|95.002|-1.6|8.2|||||The difference in percentages and its 95.002% confidence interval (CI) were calculated based on an unconditional exact method using 2 inverted 1-sided tests.|||8.2|-1.6|
72596603|NCT02603107|144724433|SUPERIORITY|||||||0.2|||||||Fisher Exact|||||||0.20
72596604|NCT02603107|144724434|SUPERIORITY||Difference in Least Squares Means (LSM)|25.0||||0.068|TWO_SIDED|95.0|-2.0|52.0|||ANOVA|||||52|-2|0.068
72596605|NCT03411902|144724436|SUPERIORITY|||||||0.048|||||||Mixed Models Analysis|||||||0.048
72596606|NCT03411902|144724437|SUPERIORITY|||||||0.745|||||||Mixed Models Analysis|||||||0.745
72596607|NCT03411902|144724438|SUPERIORITY|||||||0.163|||||||Mixed Models Analysis|||||||0.163
72596608|NCT03411902|144724439|SUPERIORITY|||||||0.013|||||||Mixed Models Analysis|||||||0.013
72596609|NCT03411902|144724440|SUPERIORITY|||||||0.337|||||||Mixed Models Analysis|||Pertaining to Radius 33 BMD||||0.337
72596610|NCT03411902|144724440|SUPERIORITY|||||||0.238|||||||Mixed Models Analysis|||Pertaining to Radius UD BMD||||0.238
72596611|NCT03411902|144724441|SUPERIORITY|||||||0.86|||||||Mixed Models Analysis|||||||0.860
72596612|NCT00419159|144724450|OTHER||Odds Ratio (OR)|1.8||||0.253|TWO_SIDED|95.0|0.657|4.929|||Unadjusted Logistic Regression|||||4.929|0.657|0.253
72596613|NCT00419159|144724451|OTHER||Odds Ratio (OR)|0.382||||0.07|TWO_SIDED|95.0|0.135|1.083|||Unadjusted Logistic Regression|||||1.083|0.135|0.070
72596614|NCT00419159|144724452|OTHER||Hazard Ratio (HR)|0.814||||0.399|TWO_SIDED|95.0|0.505|1.312|||Unadjusted Logistic Regression|||||1.312|0.505|0.399
72596615|NCT00419159|144724452|OTHER||Hazard Ratio, log|1.001||||0.995|TWO_SIDED|95.0|0.62|1.617|||Unadjusted Logistic Regression|||||1.617|0.620|0.995
72596616|NCT00419159|144724453|OTHER||Hazard Ratio, log|1.203||||0.441|TWO_SIDED|95.0|0.752|1.923|||Unadjusted Logistic Regression|||||1.923|0.752|0.441
72596617|NCT00419159|144724453|OTHER||Hazard Ratio, log|1.547||||0.126|TWO_SIDED|95.0|0.884|2.708|||Unadjusted Logistic Regression|||||2.708|0.884|0.126
72596618|NCT00419159|144724454|OTHER||Odds Ratio (OR)|0.529||||0.238|TWO_SIDED|95.0|0.184|1.523|||Unadjusted Logistic Regression|||||1.523|0.184|0.238
72596619|NCT00419159|144724455|OTHER||Odds Ratio (OR)|1.044||||0.938|TWO_SIDED|95.0|0.352|3.099|||Unadjusted Logistic Regression|||||3.099|0.352|0.938
72596620|NCT00419159|144724456|OTHER||Hazard Ratio (HR)|1.474||||0.145|TWO_SIDED|95.0|0.875|2.484|||Unadjusted Cox Model|||||2.484|0.875|0.145
72596621|NCT00419159|144724456|OTHER||Hazard Ratio, log|1.151||||0.583|TWO_SIDED|95.0|0.696|1.903|||Unadjusted Cox Model|||||1.903|0.696|0.583
72415532|NCT01329029|144341866|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.083|STANDARD_ERROR_OF_MEAN|0.3832||0.8208|TWO_SIDED|95.0|0.542|2.167||Level of significance: 5% 2-sided.|Cox-proportional hazards model||A hazards ratio of \< 1 represents a lower hazard for the test treatment.|||2.167|0.542|0.8208
72415533|NCT01329029|144341868|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.977|STANDARD_ERROR_OF_MEAN|0.0865||0.7943|TWO_SIDED|95.0|0.821|1.162||Level of significance: 5% 2-sided.|Cox-proportional hazards model|||||1.162|0.821|0.7943
72415534|NCT00506493|144341874|SUPERIORITY_OR_OTHER_LEGACY||Binomial Proportions|42.6|STANDARD_ERROR_OF_MEAN|6.3|<|0.01|ONE_SIDED|97.5|30.0|||The percent of patients off Class I and III AADs and successfully converted out of AF following treatment (ptest) will exceed the percent of patients off Class I and III AADs and convereted out of AF, as reported in literature (pcontrol=22.1%)|Fisher Exact|||"The specific test hypothesis is as follows:~H0: ptest ≤ 22.1% Ha: ptest \> 22.1%"|||30.0|<0.01
72415535|NCT00506493|144341875|SUPERIORITY_OR_OTHER_LEGACY||binomial proportions|6.7|||<|0.0001|ONE_SIDED|97.5||14.9|||Fisher Exact|||||14.9||<0.0001
72596622|NCT00419159|144724457|OTHER||Hazard Ratio (HR)|0.868||||0.588|TWO_SIDED|95.0|0.521|1.447|||Unadjusted Cox Model|||||1.447|0.521|0.588
72596623|NCT00419159|144724457|OTHER||Hazard Ratio (HR)|0.611||||0.148|TWO_SIDED|95.0|0.314|1.191|||Unadjusted Cox Model|||||1.191|0.314|0.148
72596624|NCT00187278|144724458|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.926||||0.3492|TWO_SIDED|95.0|0.789|1.0088||adjusted p|Regression, Cox|||||1.0088|0.789|0.3492
72596625|NCT00187278|144724459|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.878||||0.0882|TWO_SIDED|95.0|0.756|1.02||adjusted p|Regression, Cox|||||1.020|0.756|0.0882
72415536|NCT02985866|144341892|SUPERIORITY|The first co-primary end point was superiority of CLC over SAP in terms of CGM-measured time below 70 mg/dL. The treatment groups were compared using linear models while adjusting for age, corresponding baseline value, previous CGM use, and a random center effect. Missing baseline data were handled by direct likelihood method. Model residuals were confirmed to be approximately normally distributed.|||||<|0.0001||||||To address the issue of multiple comparisons with 2 primary outcomes, the intervention was considered effective only if both co-primary outcomes were statistically significant at 5% level. P value for noninferiority NI (prespecified NI limit = 5%).|Mixed Models Analysis|The groups were compared using linear models while adjusting for age, corresponding baseline value, previous CGM use, and a random center effect.||Statistical analyses were performed on an intention-to-treat basis, and all participants with any amount of post randomization data were included in all analyses.||||<0.0001
72596626|NCT00187278|144724460|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.97||||0.8215|TWO_SIDED|95.0|0.74|1.27|||Regression, Cox|||||1.27|0.74|0.8215
72596627|NCT00803205|144724475|SUPERIORITY|||||||0.3264|||||||ANOVA|||||||0.3264
72596628|NCT00803205|144724476|SUPERIORITY||Mean Difference (Final Values)|2.754|STANDARD_ERROR_OF_MEAN|1.78124||0.1235|TWO_SIDED|95.0|-0.756|6.264||The p-value is the LS-mean for the comparison between active treatment and placebo. The level of significance was 0.04998.|Mixed Models Analysis|||Least squares (LS) mean estimates based on mixed model for repeated measures (Weeks 8, 16, 24, 32, 40 and 48) of relative change in percent-predicted FEV1 as the dependent variable; independent variables including Baseline percent-predicted FEV1, treatment, visit, interactions between treatment and visit and between Baseline percent-predicted FEV1 and visit; and stratification factors of Baseline age, Baseline inhaled antibiotics, and Baseline percent-predicted FEV1.||6.2640|-0.7560|0.1235
72596629|NCT00379808|144724509|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.0||||0.22|||||||Wilcoxon sign rank test|||Statistical power was calculated using G\*Power (Dusseldorf, Germany). Based on previously observed effects of statin drugs on hsCRP levels, 22 subjects provided 80% power to detect a moderate effect on hsCRP levels.||||0.22
72596630|NCT00379808|144724510|SUPERIORITY_OR_OTHER||percent difference|3.8||||0.57|||||||Wilcoxon sign rank|||Null hypothesis is that montelukast does not affect HDL. Not powered for this endpoint||||0.57
72596631|NCT00379808|144724511|SUPERIORITY_OR_OTHER||percent difference|7.4||||0.33|||||||wilcoxon sign rank|||The null hypothesis is that montelukast does not affect triglycerides. The study was not powered to this outcome measure.||||0.33
72596632|NCT00379808|144724512|SUPERIORITY_OR_OTHER||percent difference|11.9||||0.12|||||||Wilcoxon|||null hypothesis is that montelukast does not affect MCP-1. Study not powered to the biomarker.||||0.12
72596633|NCT00379808|144724513|SUPERIORITY_OR_OTHER||percent difference|13.3||||0.03|||||||wilcoxon sign rank test|||null hypothesis is that montelukast does not affect IL1ra.||||0.03
72596634|NCT00379808|144724514|SUPERIORITY_OR_OTHER||percent difference|16.5||||0.09|||||||wilcoxon sign rank|||null hypothesis is that montelukast does not affect ENA-78. The study is not powered to this biomarker||||0.09
72596635|NCT01432561|144724515|SUPERIORITY_OR_OTHER|||||||0.04||95.0|||||ANOVA|||High-fat/calorie compared to fasted condition||||.04
72596636|NCT01432561|144724515|SUPERIORITY_OR_OTHER|||||||0.005||95.0|||||ANOVA|||High-protein compared to fasted condition||||.005
72596637|NCT01432561|144724516|SUPERIORITY_OR_OTHER|||||||0.16||95.0|||||ANOVA|||High-fat/calorie compared to fasted condition||||.16
72596638|NCT01432561|144724516|SUPERIORITY_OR_OTHER|||||||0.036||95.0|||||ANOVA|||High-protein compared to fasted condition||||.036
72596639|NCT01432561|144724517|SUPERIORITY_OR_OTHER|||||||0.3||95.0|||||Non-parametric Hodges-Lehmann method|||Fed high-fat/calorie compared to fasted condition.||||.30
72596640|NCT01432561|144724517|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||Non-parametric Hodges-Lehmann method|||High-protein compared to fasted condition||||.05
72596641|NCT00508157|144724550|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.28|||||TWO_SIDED|95.0|-19.14|-2.66|||ANCOVA|ANCOVA model: log of on-treatment to baseline ratio = log of baseline value, treatment, previous antipsychotic.|Relative difference of Aripiprazole vs. Control Group in terms of (mean % change from baseline/100)+1.|Null hypothesis: no difference in mean percent change from baseline in fasting non-HDLC between aripiprazole and the control group at Week 16||-2.66|-19.14|
72596642|NCT00508157|144724551|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.76|||||TWO_SIDED|95.0|0.54|1.06|||Cochran-Mantel-Haenszel|A relative risk \< 1 favors Aripiprazole over Control Group.||null hypothesis: no difference between Aripiprazole and Control Group||1.06|0.54|
72596643|NCT02069093|144724559|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Incidence rate R|||A test of the incidence rate R was performed with null hypothesis H0: R\>= 0.33 and alternative hypothesis Ha: R\<0.33 with a one-sided significance level of 0.05. If the test statistic was negative (actual incidence rate was \<0.33), the one-sided p-value for the null hypothesis R\>=0.33 was presented. The null hypothesis was rejected if the statistic was negative and the corresponding p-value for the one-sided test was \<0.5.||||<0.001
72596644|NCT00862459|144724571|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.59|STANDARD_DEVIATION|1.49||0.003|||||||t-test, 2 sided|||2 sample t-test between the dose groups||||0.003
72596645|NCT00862459|144724571|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.04|STANDARD_DEVIATION|1.59||0.844|||||||t-test, 2 sided|||||||0.844
72596646|NCT00862459|144724572|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.069|STANDARD_DEVIATION|2.92||||95.0|-0.825|0.69|||confidence interval using t-distribution|||||0.69|-0.825|
72596647|NCT00862459|144724572|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.53|STANDARD_DEVIATION|3.18||||95.0|-0.9|0.79|||confidence interval using t-distribution|||||0.79|-0.90|
72596648|NCT00862459|144724573|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8|STANDARD_DEVIATION|1.42||||95.0|-1.17|-0.42|||confidence interval using t-distribution|||||-0.42|-1.17|
72596649|NCT00862459|144724573|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01|STANDARD_DEVIATION|1.57||||95.0|-0.44|0.41|||confidence interval using t-distribution|||||0.41|-0.44|
72596650|NCT00862459|144724574|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|STANDARD_DEVIATION|0.86||||95.0|-0.619|-0.17|||confidence interval using t-distribution|||||-0.17|-0.619|
72596651|NCT00862459|144724574|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02|STANDARD_DEVIATION|1.01||||95.0|-0.25|0.22|||confidence interval using t-distribution|||||0.22|-0.25|
72596652|NCT00862459|144724575|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.38|STANDARD_DEVIATION|0.76||||95.0|-0.58|-0.18|||confidence interval using t-distribution|||||-0.18|-0.58|
72596653|NCT00862459|144724575|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1|STANDARD_DEVIATION|0.76||||95.0|-0.1|0.31|||confidence interval using t-distribution|||||0.31|-0.10|
72596654|NCT00862459|144724576|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.54|STANDARD_DEVIATION|76.45||||95.0|-37.11|2.02|||confidence interval using t-distribution|||difference in CNR between doses and confidence interval||2.02|-37.11|
72596655|NCT00862459|144724576|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.74|STANDARD_DEVIATION|77.11||||95.0|-15.86|25.35|||confidence interval using t-distribution|||||25.35|-15.86|
72596656|NCT00862459|144724577|SUPERIORITY_OR_OTHER||accuracy difference|1.66|STANDARD_ERROR_OF_MEAN|6.29||0.8||95.0|-10.93|14.24|||Chi-squared|Adjusted for clustering||||14.24|-10.93|0.80
72596657|NCT00862459|144724577|SUPERIORITY_OR_OTHER||difference in accuracies|-10.75|STANDARD_ERROR_OF_MEAN|6.83||0.13||95.0|-24.41|2.9|||Chi-squared|adjusted for clustering||||2.90|-24.41|0.13
72596658|NCT00862459|144724578|SUPERIORITY_OR_OTHER||difference in accuracy|13.43||||0.03||95.0|1.53|25.33|||Chi-squared|adjusted for clustering||||25.33|1.53|0.03
72421596|NCT03720938|144354379|SUPERIORITY|||||||0||||||The outcome of body mass index z score was tested for any difference between groups by covariate analysis (ANCOVA) adjusted for the body mass index z score at baseline and confounding variable age.|ANCOVA|||Null hypothesis was the absence of difference between the two groups for the dependent variable body mass index z score.||||0.000
72421597|NCT03720938|144354379|SUPERIORITY|||||||0.0001402||||||Linear mixed-effects model fit by maximum likelihood since restricted maximum likelihood assumes a strong normality.|Linear mixed effects model|Adjusted for cluster effect in addition to baseline value and age.||Null hypothesis was the absence of difference between the two groups for the dependent variable body mass index z score.||||0.0001402
72596659|NCT00862459|144724578|SUPERIORITY_OR_OTHER||difference in accuracies|-13.58||||0.02||95.0|-25.07|-2.09|||Chi-squared|adjusted for clustering||||-2.09|-25.07|0.02
72596660|NCT00862459|144724579|SUPERIORITY_OR_OTHER||difference in accuracy|-6.13||||0.11||95.0|-13.73|1.48|||Chi-squared|adjusted for clustering||||1.48|-13.73|0.11
72596661|NCT00862459|144724579|SUPERIORITY_OR_OTHER||difference in accuracies|2.87||||0.55||95.0|-6.59|12.32|||Chi-squared|adjusted for clustering||||12.32|-6.59|0.55
72596662|NCT00862459|144724580|SUPERIORITY_OR_OTHER||difference in accuracy|24.63||||0.02||95.0|5.39|43.86|||Chi-squared|adjusted for clustering||||43.86|5.39|0.02
72596663|NCT00862459|144724580|SUPERIORITY_OR_OTHER||difference in accuracy|-10.75||||0.13||95.0|-24.41|2.9|||Chi-squared|adjusted for clustering||||2.90|-24.41|0.13
72596664|NCT00862459|144724581|SUPERIORITY_OR_OTHER||difference in accuracy|12.91||||0.07||95.0|-1.44|27.26|||Chi-squared|adjusted for clustering||||27.26|-1.44|0.07
72596665|NCT00862459|144724581|SUPERIORITY_OR_OTHER||difference in accuracy|-18.37||||0.02||95.0|-33.6|-1.35|||Chi-squared|adjusted for clustering||||-1.35|-33.60|0.02
72596666|NCT00862459|144724582|SUPERIORITY_OR_OTHER||difference in accuracy|18.46||||0.02||95.0|3.15|33.77|||Chi-squared|adjusted for clustering||||33.77|3.15|0.02
72596667|NCT00862459|144724582|SUPERIORITY_OR_OTHER||difference in accuracy|-5.29||||0.45||95.0|-18.83|8.24|||Chi-squared|adjusted for clustering||||8.24|-18.83|0.45
72596668|NCT02240069|144724651|SUPERIORITY||Mean Difference (Net)|-0.11||||0.1|TWO_SIDED|95.0|-0.24|0.02|||Mixed Models Analysis|Linear mixed models with a fixed term for mean pre-intervention response measure, and a nested random effect to account for repeated measures.||Pre- to post-intervention change in FEV1 for Education group relative to Placebo group||0.02|-0.24|0.10
72596669|NCT02240069|144724651|SUPERIORITY||Mean Difference (Net)|0.01||||0.9|TWO_SIDED|95.0|-0.11|0.13|||Mixed Models Analysis|Linear mixed models with a fixed term for mean pre-intervention response measure, and a nested random effect to account for repeated measures.||Pre- to post-intervention change in FEV1 for Filtration group relative to Placebo group||0.13|-0.11|0.90
72596670|NCT02240069|144724652|SUPERIORITY||Mean Difference (Net)|-0.09||||0.28|TWO_SIDED|95.0|-0.24|0.07|||Mixed Models Analysis|Linear mixed models with a fixed term for mean pre-intervention response measure, and a nested random effect to account for repeated measures.||Pre- to post-intervention change in FVC for Education group relative to Placebo group||0.07|-0.24|0.28
72596671|NCT02240069|144724652|SUPERIORITY||Mean Difference (Net)|0.01||||0.89|TWO_SIDED|95.0|-0.14|0.16|||Mixed Models Analysis|Linear mixed models with a fixed term for mean pre-intervention response measure, and a nested random effect to account for repeated measures.||Pre- to post-intervention change in FVC for Filter group relative to Placebo group||0.16|-0.14|0.89
72596672|NCT02240069|144724653|SUPERIORITY||Mean Difference (Net)|-0.02||||0.06|TWO_SIDED|95.0|-0.05|0.0|||Mixed Models Analysis|Linear mixed models with a fixed term for mean pre-intervention response measure, and a nested random effect to account for repeated measures.||Pre- to post-intervention change in FEV1/FVC for Education group relative to Placebo group||0.00|-0.05|0.06
72596673|NCT02240069|144724653|SUPERIORITY||Mean Difference (Net)|0.0||||0.71|TWO_SIDED|95.0|-0.03|0.02|||Mixed Models Analysis|Linear mixed models with a fixed term for mean pre-intervention response measure, and a nested random effect to account for repeated measures.||Pre- to post-intervention change in FEV1/FVC for Filter group relative to Placebo group||0.02|-0.03|0.71
72596674|NCT02240069|144724654|SUPERIORITY||Mean Difference (Net)|-3.46||||0.39|TWO_SIDED|95.0|-11.45|4.54|||Mixed Models Analysis|Linear mixed models with a fixed term for mean pre-intervention response measure, and a nested random effect to account for repeated measures.||Pre- to post-intervention change in systolic blood pressure for Education group relative to Placebo group||4.54|-11.45|0.39
72596675|NCT02240069|144724654|SUPERIORITY||Mean Difference (Net)|0.25||||0.95|TWO_SIDED|95.0|-7.73|8.24|||Mixed Models Analysis|Linear mixed models with a fixed term for mean pre-intervention response measure, and a nested random effect to account for repeated measures.||Pre- to post-intervention change in systolic blood pressure for Filter group relative to Placebo group||8.24|-7.73|0.95
72596676|NCT02240069|144724655|SUPERIORITY||Mean Difference (Net)|-1.0||||0.65|TWO_SIDED|95.0|-5.42|3.42|||Mixed Models Analysis|Linear mixed models with a fixed term for mean pre-intervention response measure, and a nested random effect to account for repeated measures.||Pre- to post-intervention change in diastolic blood pressure for Education group relative to Placebo group||3.42|-5.42|0.65
72596677|NCT02240069|144724655|SUPERIORITY||Mean Difference (Net)|-0.58||||0.79|TWO_SIDED|95.0|-4.97|3.81|||Mixed Models Analysis|Linear mixed models with a fixed term for mean pre-intervention response measure, and a nested random effect to account for repeated measures.||Pre- to post-intervention change in diastolic blood pressure for Filter group relative to Placebo group||3.81|-4.97|0.79
72596678|NCT02240069|144724656|SUPERIORITY||Mean Difference (Net)|-2.9||||0.88|TWO_SIDED|95.0|-33.6|42.0|||Mixed Models Analysis|Linear mixed models adjusted for pre-intervention PM2.5. The model includes a nested random term to account for repeated measures.||Pre- to post-intervention change in indoor PM2.5 concentration for Education group relative to Placebo group||42.0|-33.6|0.88
72596679|NCT02240069|144724656|SUPERIORITY||Mean Difference (Net)|-50.5|||<|0.001|TWO_SIDED|95.0|-66.1|-27.8|||Mixed Models Analysis|Linear mixed models adjusted for pre-intervention PM2.5. The model includes a nested random term to account for repeated measures.||Pre- to post-intervention change in indoor PM2.5 concentration for Filter group relative to Placebo group||-27.8|-66.1|<0.001
72596680|NCT04907227|144724657|OTHER||Hazard Ratio (HR)|0.88|||||TWO_SIDED|95.0|0.32|2.46|||||HR based on Cox regression model with Efron's method of tie handling with treatment as a covariate.|||2.46|0.32|
72596681|NCT04907227|144724658|OTHER||Hazard Ratio (HR)|1.59|||||TWO_SIDED|95.0|0.68|3.67|||||HR based on Cox regression model with Efron's method of tie handling with treatment as a covariate.|||3.67|0.68|
72596682|NCT04907227|144724659|OTHER||Hazard Ratio (HR)|0.82|||||TWO_SIDED|95.0|0.45|1.5|||||HR based on Cox regression model with Efron's method of tie handling with treatment as a covariate.|||1.50|0.45|
72596683|NCT04907227|144724661|OTHER||Percent Difference|4.3|||||TWO_SIDED|95.0|-24.1|31.2|||||Based on Miettinen \& Nurminen method.|||31.2|-24.1|
72596684|NCT04907227|144724663|OTHER||Hazard Ratio (HR)|0.58|||||TWO_SIDED|95.0|0.17|1.99|||||HR based on Cox regression model with Efron's method of tie handling with treatment as a covariate.|||1.99|0.17|
72596685|NCT04907227|144724664|OTHER||Hazard Ratio (HR)|1.64|||||TWO_SIDED|95.0|0.15|18.24|||||HR based on Cox regression model with Efron's method of tie handling with treatment as a covariate.|||18.24|0.15|
72596686|NCT04907227|144724665|OTHER||Hazard Ratio (HR)|0.78|||||TWO_SIDED|95.0|0.41|1.46|||||HR based on Cox regression model with Efron's method of tie handling with treatment as a covariate.|||1.46|0.41|
72596687|NCT04907227|144724666|OTHER||Hazard Ratio (HR)|1.17|||||TWO_SIDED|95.0|0.43|3.17|||||HR based on Cox regression model with Efron's method of tie handling with treatment as a covariate.|||3.17|0.43|
72596688|NCT00824434|144724682|SUPERIORITY_OR_OTHER||Mean In-stent Late Loss in WH Lesions|0.17|||<|0.0001|ONE_SIDED|95.0||0.22|||t-test, 1 sided|||The Student t-test was used to compare the outcome to a prespecified performance goal of 0.44 mm based on an historical TAXUS Express workhorse 9-month in-stent late loss (0.41 mm) value plus delta (0.03 mm)||0.22||<0.0001
72596689|NCT00824434|144724683|SUPERIORITY_OR_OTHER||Percent Post-procedure Incomplete Apposi|5.7|||<|0.0001|ONE_SIDED|95.0||11.6|||One-sided exact binomial test|||A one-sided 95% Clopper-Pearson upper confidence bound was derived and tested to determine if the outcome was less than a prespecified performance goal based on historical XIENCE V/PROMUS post-procedure incomplete apposition data from the SPIRIT III study (34.4%).||11.6||<0.0001
72596690|NCT00474786|144724697|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.87||||0.1933|TWO_SIDED|95.0|0.71|1.07||Stratified for nephrectomy status, duration of response to sunitinib therapy, tumor histology, and Memorial Sloan Kettering Cancer Center (MSKCC) prognostic group.|Log Rank||Hazard ratio less than (\<) 1 means temsirolimus (TEMSR) is at lower risk.|||1.07|0.71|0.1933
72596691|NCT00474786|144724698|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.87||||0.1888|TWO_SIDED|95.0|0.7|1.07||Stratified for nephrectomy status, duration of response to sunitinib therapy, tumor histology, and Memorial Sloan Kettering Cancer Center (MSKCC) prognostic group.|Log Rank||Hazard ratio less than (\<) 1 means temsirolimus (TEMSR) is at lower risk.|||1.07|0.70|0.1888
72596692|NCT00474786|144724700|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.31||||0.0144|TWO_SIDED|95.0|1.05|1.63||Stratified for nephrectomy status, duration of response to sunitinib therapy, tumor histology, and MSKCC prognostic group.|Log Rank||Hazard ratio \<1 means temsirolimus (TEMSR) is at lower risk.|||1.63|1.05|0.0144
72596693|NCT00432276|144724704|NON_INFERIORITY_OR_EQUIVALENCE|The analysis was conducted at the 1-sided 0.025 significance level. Non-inferiority was demonstrated if the upper confidence limit for the LS mean difference was less than +0.3%.|LS mean difference|-0.47|||||ONE_SIDED|97.5||-0.35|||ANCOVA||Least squares means are from an ANCOVA model with treatment, study schedule, and geographic region as class variables, and baseline metformin dose and baseline HbA1c as covariates.|The analysis was conducted at the 1-sided 0.025 significance level. Non-inferiority was demonstrated if the upper confidence limit for the LS mean difference was less than +0.3%.||-0.35||
72596694|NCT00432276|144724704|NON_INFERIORITY_OR_EQUIVALENCE|The analysis was conducted at the 1-sided 0.025 significance level. Non-inferiority was demonstrated if the upper confidence limit for the LS mean difference was less than +0.3%.|LS mean difference|-0.42|||||ONE_SIDED|97.5||-0.28|||ANCOVA||Least squares means are from an ANCOVA model with treatment, study schedule, and geographic region as class variables, and baseline metformin dose and baseline HbA1c as covariates.|Comparison of Change from Baseline at Week 52. The null hypothesis was that the average change from Baseline in HbA1c at Week 52 for the alogliptin 25 mg addition group is inferior to the average change for the pioglitazone titration group. The alternative hypothesis was that the change from Baseline in HbA1c for the alogliptin 25 mg addition group was non-inferior to the change for the pioglitazone titration group for at Week 52.||-0.28||
72596695|NCT00432276|144724705|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.44|||<|0.001|TWO_SIDED|95.0|-0.57|-0.31||Statistical tests and resulting P-values are 2-sided and was evaluated at the 0.05 significance level.|ANCOVA|ANCOVA model with treatment, study schedule, and geographic region as class variables, and baseline metformin dose and baseline HbA1c as covariates.||Comparison of change from Baseline in HbA1c at Week 42.||-0.31|-0.57|<0.001
72596696|NCT00432276|144724713|SUPERIORITY_OR_OTHER||LS Mean Difference|-10.9|||<|0.001|TWO_SIDED|95.0|-16.2|-5.7||Statistical test and resulting P-value are 2-sided and was evaluated at the 0.05 significance level.|ANCOVA|ANCOVA model with treatment, study schedule and geographic region as class variables, and baseline metformin dose and FPG as covariates.||Comparison of change from Baseline at Week 52.||-5.7|-16.2|<0.001
72596697|NCT00432276|144724714|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical test and resulting P-value are 2-sided and was evaluated at the 0.05 significance level.|Extended Mantel Haenszel Test|Treatment comparison was performed using nonparametric, covariance-adjusted, extended Mantel-Haenszel test.||Comparison of incidence of marked hyperglycemia through Week 52.||||<0.001
72596698|NCT00432276|144724715|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical test and resulting P-value are 2-sided and was evaluated at the 0.05 significance level.|Extended Mantel Haenszel Test|Treatment comparison was performed using nonparametric, covariance-adjusted, extended Mantel-Haenszel test.||Comparison of incidence of hyperglycemic rescue through Week 52.||||<0.001
72415537|NCT02985866|144341893|NON_INFERIORITY|The second co-primary end point was noninferiority in CGM-measured time above 180 mg/dL, with a noninferiority limit of 5%. The treatment groups were compared using linear models while adjusting for age, corresponding baseline value, previous CGM use, and a random center effect. Missing baseline data were handled by direct likelihood method. Model residuals were confirmed to be approximately normally distributed.|||||<|0.0001||||||To address the issue of multiple comparisons with 2 primary outcomes, the intervention was considered effective only if both co-primary outcomes were statistically significant at 5% level. P value for noninferiority NI (prespecified NI limit = 5%).|Mixed Models Analysis|The groups were compared using linear models while adjusting for age, corresponding baseline value, previous CGM use, and a random center effect.||Statistical analyses were performed on an intention-to-treat basis, and all participants with any amount of post randomization data were included in all analyses.||||<0.0001
72415538|NCT02985866|144341894|SUPERIORITY|Same as for primary outcome 1|||||<|0.05||||||All secondary analyses were corrected for multiple comparisons using the false discovery rate at a 10% level for statistical significance. All secondary P values reported are two-sided.|Mixed Models Analysis|The groups were compared using linear models while adjusting for age, corresponding baseline value, previous CGM use, and a random center effect.||Same as for the primary outcomes||||<0.05
72415539|NCT02985866|144341895|SUPERIORITY|Same as for primary outcome 1|||||<|0.05||||||All secondary analyses were corrected for multiple comparisons using the false discovery rate at a 10% level for statistical significance. All secondary P values reported are two-sided.|Mixed Models Analysis|The groups were compared using linear models while adjusting for age, corresponding baseline value, previous CGM use, and a random center effect.||Same as for the primary outcomes||||<0.05
72415540|NCT02985866|144341896|SUPERIORITY|Same as for primary outcome 1|||||<|0.05||||||All secondary analyses were corrected for multiple comparisons using the false discovery rate at a 10% level for statistical significance. All secondary P values reported are two-sided.|Mixed Models Analysis|The groups were compared using linear models while adjusting for age, corresponding baseline value, previous CGM use, and a random center effect.||Same as for the primary outcomes||||<0.05
72415541|NCT02985866|144341897|SUPERIORITY|Same as for primary outcome 1|||||<|0.05||||||All secondary analyses were corrected for multiple comparisons using the false discovery rate at a 10% level for statistical significance. All secondary P values reported are two-sided.|Mixed Models Analysis|The groups were compared using linear models while adjusting for age, corresponding baseline value, previous CGM use, and a random center effect.||Same as for the primary outcomes||||<0.05
72415542|NCT02985866|144341898|SUPERIORITY|Same as for primary outcome 1|||||<|0.05||||||All secondary analyses were corrected for multiple comparisons using the false discovery rate at a 10% level for statistical significance. All secondary P values reported are two-sided.|Mixed Models Analysis|The groups were compared using linear models while adjusting for age, corresponding baseline value, previous CGM use, and a random center effect.||Same as for the primary outcomes||||<0.05
72415543|NCT02985866|144341899|SUPERIORITY|Same as for primary outcome 1|||||<|0.05||||||All secondary analyses were corrected for multiple comparisons using the false discovery rate at a 10% level for statistical significance. All secondary P values reported are two-sided.|Mixed Models Analysis|The groups were compared using linear models while adjusting for age, corresponding baseline value, previous CGM use, and a random center effect.||Same as for the primary outcomes||||<0.05
72415544|NCT02985866|144341900|SUPERIORITY|Same as for primary outcome 1|||||<|0.05||||||All secondary analyses were corrected for multiple comparisons using the false discovery rate at a 10% level for statistical significance. All secondary P values reported are two-sided.|Mixed Models Analysis|The groups were compared using linear models while adjusting for age, corresponding baseline value, previous CGM use, and a random center effect.||Same as for the primary outcomes||||<0.05
72596699|NCT00432276|144724716|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.6||||0.116|TWO_SIDED|95.0|-3.7|0.4||Statistical test and resulting P-value are 2-sided and was evaluated at the 0.05 significance level.|ANCOVA|ANCOVA model with treatment, study schedule and geographic region as class variables, and baseline metformin dose and proinsulin as covariates.||Comparison of change from Baseline at Week 52.||0.4|-3.7|0.116
72596700|NCT00432276|144724717|SUPERIORITY_OR_OTHER||LS Mean Difference|0.73||||0.276|TWO_SIDED|95.0|-0.58|2.04||Statistical test and resulting P-value are 2-sided and was evaluated at the 0.05 significance level.|ANCOVA|ANCOVA model with treatment, study schedule and geographic region as class variables, and baseline metformin dose and fasting insulin as covariates.||Comparison of change from Baseline at Week 52.||2.04|-0.58|0.276
72415545|NCT00515502|144341927|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|1.31|||TWO_SIDED|95.0|-3.0|2.2|||Mixed Models Analysis|||||2.2|-3.0|
72596701|NCT00432276|144724718|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.041|||<|0.001|TWO_SIDED|95.0|-0.063|-0.018||Statistical test and resulting P-value are 2-sided and was evaluated at the 0.05 significance level.|ANCOVA|Treatment, study schedule and geographic region as class variables, and baseline metformin dose and baseline proinsulin/insulin ratio as covariates.||Comparison of change from Baseline at Week 52.||-0.018|-0.063|<0.001
72415546|NCT00515502|144341927|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.4|STANDARD_ERROR_OF_MEAN|1.25|||TWO_SIDED|95.0|-2.1|2.9|||Mixed Models Analysis|||||2.9|-2.1|
72596702|NCT00432276|144724719|SUPERIORITY_OR_OTHER||LS Mean Difference|0.073||||0.23|TWO_SIDED|95.0|-0.047|0.193||Statistical test and resulting P-value are 2-sided and was evaluated at the 0.05 significance level.|ANCOVA|Treatment, study schedule and geographic region as class variables, and baseline metformin dose and baseline fasting C-peptide as covariates.||Comparison of change from Baseline at Week 52.||0.193|-0.047|0.230
72415547|NCT00515502|144341927|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.1|STANDARD_ERROR_OF_MEAN|1.77|||TWO_SIDED|95.0|-1.4|5.7|||Mixed Models Analysis|||||5.7|-1.4|
72415548|NCT00515502|144341927|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.7|STANDARD_ERROR_OF_MEAN|1.79|||TWO_SIDED|95.0|-6.2|0.9|||Mixed Models Analysis|||||0.9|-6.2|
72415549|NCT00515502|144341927|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.3|STANDARD_ERROR_OF_MEAN|1.78|||TWO_SIDED|95.0|-1.3|5.8|||Mixed Models Analysis|||||5.8|-1.3|
72415550|NCT00515502|144341927|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.1|STANDARD_ERROR_OF_MEAN|1.89|||TWO_SIDED|95.0|-0.7|6.9|||Mixed Models Analysis|||||6.9|-0.7|
72415551|NCT00515502|144341927|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.8|STANDARD_ERROR_OF_MEAN|2.46|||TWO_SIDED|95.0|-0.1|9.7|||Mixed Models Analysis|||||9.7|-0.1|
72596703|NCT00432276|144724720|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.188||||0.567|TWO_SIDED|95.0|-0.83|0.455||Statistical test and resulting P-value are 2-sided and was evaluated at the 0.05 significance level.|ANCOVA|Treatment, study schedule and geographic region as class variables, and baseline metformin dose and baseline HOMA insulin resistance as covariates.||Comparison of change from Baseline at Week 52.||0.455|-0.830|0.567
72596704|NCT00432276|144724721|SUPERIORITY_OR_OTHER||LS Mean Difference|12.963|||<|0.001|TWO_SIDED|95.0|5.333|20.592||Statistical test and resulting P-value are 2-sided and was evaluated at the 0.05 significance level.|ANCOVA|Treatment, study schedule and geographic region as class variables, and baseline metformin dose and baseline HOMA beta cell function as covariates.||Comparison of change from Baseline at Week 52.||20.592|5.333|<0.001
72596705|NCT00432276|144724722|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.5||||0.071|TWO_SIDED|95.0|-1.03|0.04||Statistical test and resulting P-value are 2-sided and was evaluated at the 0.05 significance level.|ANCOVA|Treatment, study schedule and geographic region as class variables, and baseline metformin dose and baseline body weight as covariates.||Comparison of change from Baseline at Week 52.||0.04|-1.03|0.071
72415552|NCT00515502|144341928|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.78|STANDARD_ERROR_OF_MEAN|0.844|||TWO_SIDED|95.0|-2.47|0.92|||Mixed Models Analysis|||||0.92|-2.47|
72415553|NCT00515502|144341928|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.04|STANDARD_ERROR_OF_MEAN|0.798|||TWO_SIDED|95.0|-0.57|2.64|||Mixed Models Analysis|||||2.64|-0.57|
72596706|NCT00432276|144724723|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.2||||0.058|TWO_SIDED|95.0|-8.6|0.1||Statistical test and resulting P-value are 2-sided and was evaluated at the 0.05 significance level.|ANCOVA|Treatment, study schedule and geographic region as class variables, and baseline metformin dose and baseline total cholesterol as covariates.||Comparison of change from Baseline at Week 52.||0.1|-8.6|0.058
72596707|NCT00432276|144724724|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.6||||0.228|TWO_SIDED|95.0|-1.7|0.4||Statistical test and resulting P-value are 2-sided and was evaluated at the 0.05 significance level.|ANCOVA|Treatment, study schedule and geographic region as class variables, and baseline metformin dose and baseline HDL cholesterol as covariates.||Comparison of change from Baseline at Week 52.||0.4|-1.7|0.228
72596708|NCT00432276|144724725|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.8||||0.132|TWO_SIDED|95.0|-6.5|0.9||Statistical test and resulting P-value are 2-sided and was evaluated at the 0.05 significance level.|ANCOVA|Treatment, study schedule and geographic region as class variables, and baseline metformin dose and baseline LDL cholesterol as covariates.||Comparison of change from Baseline at Week 52.||0.9|-6.5|0.132
72415554|NCT00515502|144341928|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.95|STANDARD_ERROR_OF_MEAN|1.151|||TWO_SIDED|95.0|-0.35|4.26|||Mixed Models Analysis|||||4.26|-0.35|
72415555|NCT00515502|144341928|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.72|STANDARD_ERROR_OF_MEAN|1.193|||TWO_SIDED|95.0|-4.11|0.67|||Mixed Models Analysis|||||0.67|-4.11|
72415556|NCT00515502|144341928|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.95|STANDARD_ERROR_OF_MEAN|1.19|||TWO_SIDED|95.0|-1.44|3.33|||Mixed Models Analysis|||||3.33|-1.44|
72415557|NCT00515502|144341928|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.76|STANDARD_ERROR_OF_MEAN|1.257|||TWO_SIDED|95.0|0.24|5.28|||Mixed Models Analysis|||||5.28|0.24|
72415558|NCT00515502|144341928|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.68|STANDARD_ERROR_OF_MEAN|1.67|||TWO_SIDED|95.0|0.34|7.02|||Mixed Models Analysis|||||7.02|0.34|
72596709|NCT00432276|144724726|SUPERIORITY_OR_OTHER||LS Mean Difference|-8.6||||0.08|TWO_SIDED|95.0|-18.3|1.0||Statistical test and resulting P-value are 2-sided and was evaluated at the 0.05 significance level.|ANCOVA|Treatment, study schedule and geographic region as class variables, and baseline metformin dose and baseline triglycerides as covariates.||Comparison of change from Baseline at Week 52.||1.0|-18.3|0.080
72596710|NCT00432276|144724727|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.0314||||0.059|TWO_SIDED|95.0|-0.064|0.0012||Statistical test and resulting P-value are 2-sided and was evaluated at the 0.05 significance level.|ANCOVA|Treatment, study schedule and geographic region as class variables, and baseline metformin dose and baseline free fatty acid as covariates.||Comparison of change from Baseline at Week 52.||0.0012|-0.0640|0.059
72415559|NCT00515502|144341929|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8|STANDARD_ERROR_OF_MEAN|2.11|||TWO_SIDED|95.0|-5.0|3.4|||Mixed Models Analysis|||||3.4|-5.0|
72415560|NCT00515502|144341929|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.5|STANDARD_ERROR_OF_MEAN|2.03|||TWO_SIDED|95.0|-7.6|0.6|||Mixed Models Analysis|||||0.6|-7.6|
72415561|NCT00515502|144341929|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.3|STANDARD_ERROR_OF_MEAN|2.74|||TWO_SIDED|95.0|-2.2|8.7|||Mixed Models Analysis|||||8.7|-2.2|
72415562|NCT00515502|144341929|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.3|STANDARD_ERROR_OF_MEAN|2.98|||TWO_SIDED|95.0|-4.7|7.2|||Mixed Models Analysis|||||7.2|-4.7|
72415563|NCT00515502|144341929|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.0|STANDARD_ERROR_OF_MEAN|2.83|||TWO_SIDED|95.0|-7.7|3.6|||Mixed Models Analysis|||||3.6|-7.7|
72415564|NCT00515502|144341929|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.8|STANDARD_ERROR_OF_MEAN|3.2|||TWO_SIDED|95.0|-11.2|1.6|||Mixed Models Analysis|||||1.6|-11.2|
72415565|NCT00515502|144341929|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.0|STANDARD_ERROR_OF_MEAN|4.0|||TWO_SIDED|95.0|-5.9|10.0|||Mixed Models Analysis|||||10.0|-5.9|
72415566|NCT00515502|144341930|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.42|STANDARD_ERROR_OF_MEAN|1.902|||TWO_SIDED|95.0|-6.23|1.39|||Mixed Models Analysis|||||1.39|-6.23|
72415567|NCT00515502|144341930|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.88|STANDARD_ERROR_OF_MEAN|1.834|||TWO_SIDED|95.0|-5.56|1.79|||Mixed Models Analysis|||||1.79|-5.56|
72415568|NCT00515502|144341930|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.12|STANDARD_ERROR_OF_MEAN|2.474|||TWO_SIDED|95.0|-3.82|6.07|||Mixed Models Analysis|||||6.07|-3.82|
72596711|NCT00432276|144724728|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1||||0.934|TWO_SIDED|95.0|-2.9|2.6||Statistical test and resulting P-value are 2-sided and was evaluated at the 0.05 significance level.|ANCOVA|Treatment, study schedule and geographic region as class variables, and baseline metformin dose and baseline apolipoprotein A1 as covariates.||Comparison of change from Baseline at Week 52.||2.6|-2.9|0.934
72596712|NCT00432276|144724729|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.6||||0.07|TWO_SIDED|95.0|-1.3|0.1||Statistical test and resulting P-value are 2-sided and was evaluated at the 0.05 significance level.|ANCOVA|Treatment, study schedule and geographic region as class variables, and baseline metformin dose and baseline apolipoprotein A2 as covariates.||Comparison of change from Baseline at Week 52.||0.1|-1.3|0.070
72596713|NCT00432276|144724730|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.9||||0.064|TWO_SIDED|95.0|-5.9|0.2||Statistical test and resulting P-value are 2-sided and was evaluated at the 0.05 significance level.|ANCOVA|Treatment, study schedule and geographic region as class variables, and baseline metformin dose and baseline apolipoprotein B as covariates.||Comparison of change from Baseline at Week 52.||0.2|-5.9|0.064
72596714|NCT00432276|144724731|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.5||||0.022|TWO_SIDED|95.0|-1.0|-0.1||Statistical test and resulting P-value are 2-sided and was evaluated at the 0.05 significance level.|ANCOVA|Treatment, study schedule and geographic region as class variables, and baseline metformin dose and baseline apolipoprotein C-III as covariates.||Comparison of change from Baseline at Week 52.||-0.1|-1.0|0.022
72596715|NCT00432276|144724732|SUPERIORITY_OR_OTHER||LS Mean Difference|1.78||||0.308|TWO_SIDED|95.0|-1.65|5.22||Statistical test and resulting P-value are 2-sided and was evaluated at the 0.05 significance level.|ANCOVA|Treatment, study schedule and geographic region as class variables, and baseline metformin dose and baseline PAI-1 as covariates.||Comparison of change from Baseline at Week 52.||5.22|-1.65|0.308
72596716|NCT00432276|144724733|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.8209||||0.283|TWO_SIDED|95.0|-2.3209|0.679||Statistical test and resulting P-value are 2-sided and was evaluated at the 0.05 significance level.|ANCOVA|Treatment, study schedule and geographic region as class variables, and baseline metformin dose and baseline hsCRP as covariates.||Comparison of change from Baseline at Week 52.||0.6790|-2.3209|0.283
72415569|NCT00515502|144341930|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.31|STANDARD_ERROR_OF_MEAN|2.697|||TWO_SIDED|95.0|-5.07|5.69|||Mixed Models Analysis|||||5.69|-5.07|
72415570|NCT00515502|144341930|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.73|STANDARD_ERROR_OF_MEAN|2.562|||TWO_SIDED|95.0|-7.84|2.38|||Mixed Models Analysis|||||2.38|-7.84|
72596717|NCT00432276|144724734|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.92|||<|0.001|TWO_SIDED|95.0|-4.57|-1.27||Statistical test and resulting P-value are 2-sided and was evaluated at the 0.05 significance level.|ANCOVA|Treatment, study schedule and geographic region as class variables, and baseline metformin dose and baseline adiponectin as covariates.||Comparison of change from Baseline at Week 52.||-1.27|-4.57|<0.001
72596718|NCT00432276|144724735|SUPERIORITY_OR_OTHER||LS Mean Difference|-6.1||||0.197|TWO_SIDED|95.0|-15.4|3.2||Statistical test and resulting P-value are 2-sided and was evaluated at the 0.05 significance level.|ANCOVA|||Comparison of change from Baseline at Week 52.||3.2|-15.4|0.197
72596719|NCT02436031|144724766|OTHER|||||||0.049|||||||Wilcoxon Matched-Pairs Signed-Rank Test|||Active Pcrit||||0.049
72596720|NCT02436031|144724766|OTHER|||||||0.135|||||||Wilcoxon Matched-Pairs Signed-Rank Test|||Passive Pcrit||||0.135
72415571|NCT00515502|144341930|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.19|STANDARD_ERROR_OF_MEAN|2.898|||TWO_SIDED|95.0|-7.97|3.59|||Mixed Models Analysis|||||3.59|-7.97|
72415572|NCT00515502|144341930|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.82|STANDARD_ERROR_OF_MEAN|3.618|||TWO_SIDED|95.0|-6.39|8.02|||Mixed Models Analysis|||||8.02|-6.39|
72415573|NCT00515502|144341931|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.5|STANDARD_ERROR_OF_MEAN|1.31|||TWO_SIDED|95.0|-5.1|0.2|||Mixed Models Analysis|||||0.2|-5.1|
72415574|NCT00515502|144341931|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.1|STANDARD_ERROR_OF_MEAN|1.25|||TWO_SIDED|95.0|-4.6|0.4|||Mixed Models Analysis|||||0.4|-4.6|
72415575|NCT00515502|144341931|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.3|STANDARD_ERROR_OF_MEAN|1.67|||TWO_SIDED|95.0|0.0|6.6|||Mixed Models Analysis|||||6.6|-0.0|
72415576|NCT00515502|144341931|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.4|STANDARD_ERROR_OF_MEAN|1.77|||TWO_SIDED|95.0|-5.9|1.2|||Mixed Models Analysis|||||1.2|-5.9|
72415577|NCT00515502|144341931|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|1.71|||TWO_SIDED|95.0|-3.5|3.3|||Mixed Models Analysis|||||3.3|-3.5|
72415578|NCT00515502|144341931|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3|STANDARD_ERROR_OF_MEAN|1.9|||TWO_SIDED|95.0|-3.5|4.1|||Mixed Models Analysis|||||4.1|-3.5|
72415579|NCT00515502|144341931|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.7|STANDARD_ERROR_OF_MEAN|2.35|||TWO_SIDED|95.0|1.0|10.4|||Mixed Models Analysis|||||10.4|1.0|
72415580|NCT00515502|144341932|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.97|STANDARD_ERROR_OF_MEAN|1.051|||TWO_SIDED|95.0|-5.08|-0.87|||Mixed Models Analysis|||||-0.87|-5.08|
72415581|NCT00515502|144341932|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.51|STANDARD_ERROR_OF_MEAN|1.006|||TWO_SIDED|95.0|-3.53|0.5|||Mixed Models Analysis|||||0.50|-3.53|
72415582|NCT00515502|144341932|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.21|STANDARD_ERROR_OF_MEAN|1.335|||TWO_SIDED|95.0|-0.46|4.88|||Mixed Models Analysis|||||4.88|-0.46|
72415583|NCT00515502|144341932|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.32|STANDARD_ERROR_OF_MEAN|1.409|||TWO_SIDED|95.0|-6.13|-0.5|||Mixed Models Analysis|||||-0.50|-6.13|
72415584|NCT00515502|144341932|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.35|STANDARD_ERROR_OF_MEAN|1.366|||TWO_SIDED|95.0|-2.38|3.07|||Mixed Models Analysis|||||3.07|-2.38|
72415585|NCT00515502|144341932|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.8|STANDARD_ERROR_OF_MEAN|1.514|||TWO_SIDED|95.0|-1.22|4.82|||Mixed Models Analysis|||||4.82|-1.22|
72415586|NCT00515502|144341932|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.53|STANDARD_ERROR_OF_MEAN|1.867|||TWO_SIDED|95.0|1.81|9.25|||Mixed Models Analysis|||||9.25|1.81|
72415587|NCT00515502|144341933|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.31|STANDARD_ERROR_OF_MEAN|3.256|||TWO_SIDED|95.0|-9.82|3.21|||Mixed Models Analysis|||||3.21|-9.82|
72415588|NCT00515502|144341933|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.69|STANDARD_ERROR_OF_MEAN|3.193|||TWO_SIDED|95.0|-4.7|8.09|||Mixed Models Analysis|||||8.09|-4.70|
72415589|NCT00515502|144341933|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.54|STANDARD_ERROR_OF_MEAN|4.268|||TWO_SIDED|95.0|-10.06|6.98|||Mixed Models Analysis|||||6.98|-10.06|
72415590|NCT00515502|144341933|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.17|STANDARD_ERROR_OF_MEAN|4.347|||TWO_SIDED|95.0|-13.84|3.5|||Mixed Models Analysis|||||3.50|-13.84|
72415591|NCT00515502|144341933|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.86|STANDARD_ERROR_OF_MEAN|4.264|||TWO_SIDED|95.0|-6.65|10.37|||Mixed Models Analysis|||||10.37|-6.65|
72415592|NCT00515502|144341933|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.86|STANDARD_ERROR_OF_MEAN|4.622|||TWO_SIDED|95.0|-2.35|16.08|||Mixed Models Analysis|||||16.08|-2.35|
72415593|NCT00515502|144341933|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.63|STANDARD_ERROR_OF_MEAN|5.634|||TWO_SIDED|95.0|-7.59|14.85|||Mixed Models Analysis|||||14.85|-7.59|
72415594|NCT00515502|144341934|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.298|STANDARD_ERROR_OF_MEAN|2.3297|||TWO_SIDED|95.0|-4.961|4.365|||Mixed Models Analysis|||||4.365|-4.961|
72415595|NCT00515502|144341934|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.066|STANDARD_ERROR_OF_MEAN|2.2776|||TWO_SIDED|95.0|-3.495|5.627|||Mixed Models Analysis|||||5.627|-3.495|
72415596|NCT00515502|144341934|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.062|STANDARD_ERROR_OF_MEAN|3.0952|||TWO_SIDED|95.0|-8.247|4.122|||Mixed Models Analysis|||||4.122|-8.247|
72415597|NCT00515502|144341934|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.362|STANDARD_ERROR_OF_MEAN|3.1891|||TWO_SIDED|95.0|-6.003|6.726|||Mixed Models Analysis|||||6.726|-6.003|
72596721|NCT04015518|144724772|OTHER|Mixed-effects Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod. MMRM included'baseline' as a continuous covariate, and 'visit', 'treatment', 'region' (stratification according to Japan vs. non-Japan), 'visit\*treatment' and 'visit\*baseline' interaction as fixed effects as well as the random 'subject' effect. Covariance structure= Unstructured.|Difference of adjusted means|-10.5|STANDARD_ERROR_OF_MEAN|8.5||0.2179|TWO_SIDED|95.0|-27.4|6.3|||Mixed Models Analysis|Kenward-Roger was used to estimate denominator degrees of freedom.|Difference was calculated as Speso - placebo.|||6.3|-27.4|0.2179
72596722|NCT04015518|144724772|OTHER|Mixed-effects Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod. MMRM included'baseline' as a continuous covariate, and 'visit', 'treatment', 'region' (stratification according to Japan vs. non-Japan), 'visit\*treatment' and 'visit\*baseline' interaction as fixed effects as well as the random 'subject' effect. Covariance structure= Unstructured.|Difference of adjusted means|-14.6|STANDARD_ERROR_OF_MEAN|8.5||0.0883|TWO_SIDED|95.0|-31.5|2.2|||Mixed Models Analysis|Kenward-Roger was used to estimate denominator degrees of freedom.|Difference was calculated as Speso - placebo.|||2.2|-31.5|0.0883
72596723|NCT04015518|144724772|OTHER|Mixed-effects Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod. MMRM included'baseline' as a continuous covariate, and 'visit', 'treatment', 'region' (stratification according to Japan vs. non-Japan), 'visit\*treatment' and 'visit\*baseline' interaction as fixed effects as well as the random 'subject' effect. Covariance structure= Unstructured.|Difference of adjusted means|-12.6|STANDARD_ERROR_OF_MEAN|8.5||0.1414|TWO_SIDED|95.0|-29.4|4.3|||Mixed Models Analysis|Kenward-Roger was used to estimate denominator degrees of freedom.|Difference was calculated as Speso - placebo.|||4.3|-29.4|0.1414
72596724|NCT04015518|144724772|OTHER|Mixed-effects Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod. MMRM included'baseline' as a continuous covariate, and 'visit', 'treatment', 'region' (stratification according to Japan vs. non-Japan), 'visit\*treatment' and 'visit\*baseline' interaction as fixed effects as well as the random 'subject' effect. Covariance structure= Unstructured.|Difference of adjusted means|-5.3|STANDARD_ERROR_OF_MEAN|7.0||0.4514|TWO_SIDED|95.0|-19.1|8.6|||Mixed Models Analysis|Kenward-Roger was used to estimate denominator degrees of freedom.|Difference was calculated as Speso - placebo.|||8.6|-19.1|0.4514
72596725|NCT04015518|144724772|OTHER|Mixed-effects Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod. MMRM included'baseline' as a continuous covariate, and 'visit', 'treatment', 'region' (stratification according to Japan vs. non-Japan), 'visit\*treatment' and 'visit\*baseline' interaction as fixed effects as well as the random 'subject' effect. Covariance structure= Unstructured.||||||0.212||||||Adjusted for multiplicity.|MCP-Mod linear model fit|||A flat vs. non-flat dose-response relationship across the 4 doses of Spesolimab and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, Emax, exponential, logistic, Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.05).||||0.2120
72596726|NCT04015518|144724772|OTHER|Mixed-effects Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod. MMRM included'baseline' as a continuous covariate, and 'visit', 'treatment', 'region' (stratification according to Japan vs. non-Japan), 'visit\*treatment' and 'visit\*baseline' interaction as fixed effects as well as the random 'subject' effect. Covariance structure= Unstructured.||||||0.1057||||||Adjusted for multiplicity.|MCP-Mod Emax model fit|"Assumed 70% of the maximum effect was achieved at the low dose regimen."||A flat vs. non-flat dose-response relationship across the 4 doses of Spesolimab and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, Emax, exponential, logistic, Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.05).||||0.1057
72596727|NCT04015518|144724772|OTHER|Mixed-effects Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod. MMRM included'baseline' as a continuous covariate, and 'visit', 'treatment', 'region' (stratification according to Japan vs. non-Japan), 'visit\*treatment' and 'visit\*baseline' interaction as fixed effects as well as the random 'subject' effect. Covariance structure= Unstructured.||||||0.5241||||||Adjusted for multiplicity.|MCP-Mod Exponential model fit|"Assumed 25% of the maximum effect was achieved at the medium-low dose regimen."||A flat vs. non-flat dose-response relationship across the 4 doses of Spesolimab and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, Emax, exponential, logistic, Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.05).||||0.5241
72415598|NCT00515502|144341934|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.66|STANDARD_ERROR_OF_MEAN|3.1121|||TWO_SIDED|95.0|-6.873|5.554|||Mixed Models Analysis|||||5.554|-6.873|
72415599|NCT00515502|144341934|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.704|STANDARD_ERROR_OF_MEAN|3.3916|||TWO_SIDED|95.0|-6.064|7.473|||Mixed Models Analysis|||||7.473|-6.064|
72415600|NCT00515502|144341934|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.424|STANDARD_ERROR_OF_MEAN|4.2233|||TWO_SIDED|95.0|-10.84|5.993|||Mixed Models Analysis|||||5.993|-10.84|
72415601|NCT00515502|144341935|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.08|STANDARD_ERROR_OF_MEAN|2.542|||TWO_SIDED|95.0|-4.98|5.15|||Mixed Models Analysis|||||5.15|-4.98|
72415602|NCT00515502|144341935|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.34|STANDARD_ERROR_OF_MEAN|2.507|||TWO_SIDED|95.0|-3.65|6.34|||Mixed Models Analysis|||||6.34|-3.65|
72415603|NCT00515502|144341935|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.15|STANDARD_ERROR_OF_MEAN|3.182|||TWO_SIDED|95.0|-7.49|5.19|||Mixed Models Analysis|||||5.19|-7.49|
72415604|NCT00515502|144341935|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.32|STANDARD_ERROR_OF_MEAN|3.296|||TWO_SIDED|95.0|-6.89|6.24|||Mixed Models Analysis|||||6.24|-6.89|
72415605|NCT00515502|144341935|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.41|STANDARD_ERROR_OF_MEAN|3.279|||TWO_SIDED|95.0|-6.13|6.94|||Mixed Models Analysis|||||6.94|-6.13|
72596728|NCT04015518|144724772|OTHER|Mixed-effects Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod. MMRM included'baseline' as a continuous covariate, and 'visit', 'treatment', 'region' (stratification according to Japan vs. non-Japan), 'visit\*treatment' and 'visit\*baseline' interaction as fixed effects as well as the random 'subject' effect. Covariance structure= Unstructured.||||||0.2773||||||Adjusted for multiplicity.|MCP-Mod Logistic model fit|"Assumed 20% of maximum effect was achieved at the low dose, 95% of maximum effect was achieved at medium high dose."||A flat vs. non-flat dose-response relationship across the 4 doses of Spesolimab and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, Emax, exponential, logistic, Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.05).||||0.2773
72596729|NCT04015518|144724772|OTHER|Mixed-effects Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod. MMRM included'baseline' as a continuous covariate, and 'visit', 'treatment', 'region' (stratification according to Japan vs. non-Japan), 'visit\*treatment' and 'visit\*baseline' interaction as fixed effects as well as the random 'subject' effect. Covariance structure= Unstructured.||||||0.3867||||||Adjusted for multiplicity.|MCP-Mod Sigmoid Emax model fit|"Assumed 10% of the maximum effect was achieved at low dose, 80% of the maximum effect was achieved at the medium-high dose."||A flat vs. non-flat dose-response relationship across the 4 doses of Spesolimab and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, Emax, exponential, logistic, Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.05).||||0.3867
72596730|NCT04015518|144724773|OTHER|Mixed-effects Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod. MMRM included'baseline' as a continuous covariate, and 'visit', 'treatment', 'region' (stratification according to Japan vs. non-Japan), 'visit\*treatment' and 'visit\*baseline' interaction as fixed effects as well as the random 'subject' effect. Covariance structure= Unstructured.|Difference of adjusted means|-6.1|STANDARD_ERROR_OF_MEAN|6.7|||TWO_SIDED|95.0|-19.3|7.1|||||Difference was calculated as Speso - placebo.|||7.1|-19.3|
72596731|NCT04015518|144724773|OTHER|Mixed-effects Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod. MMRM included'baseline' as a continuous covariate, and 'visit', 'treatment', 'region' (stratification according to Japan vs. non-Japan), 'visit\*treatment' and 'visit\*baseline' interaction as fixed effects as well as the random 'subject' effect. Covariance structure= Unstructured.|Difference of adjusted means|-5.4|STANDARD_ERROR_OF_MEAN|6.8|||TWO_SIDED|95.0|-18.8|8.0|||||Difference was calculated as Speso - placebo.|||8.0|-18.8|
72596732|NCT04015518|144724773|OTHER|Mixed-effects Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod. MMRM included'baseline' as a continuous covariate, and 'visit', 'treatment', 'region' (stratification according to Japan vs. non-Japan), 'visit\*treatment' and 'visit\*baseline' interaction as fixed effects as well as the random 'subject' effect. Covariance structure= Unstructured.|Difference of adjusted means|-3.5|STANDARD_ERROR_OF_MEAN|6.6|||TWO_SIDED|95.0|-16.6|9.7|||||Difference was calculated as Speso - placebo.|||9.7|-16.6|
72596733|NCT04015518|144724773|OTHER|Mixed-effects Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod. MMRM included'baseline' as a continuous covariate, and 'visit', 'treatment', 'region' (stratification according to Japan vs. non-Japan), 'visit\*treatment' and 'visit\*baseline' interaction as fixed effects as well as the random 'subject' effect. Covariance structure= Unstructured.|Difference of adjusted means|-9.4|STANDARD_ERROR_OF_MEAN|5.5|||TWO_SIDED|95.0|-20.3|1.4|||||Difference was calculated as Speso - placebo.|||1.4|-20.3|
72596734|NCT04015518|144724774|OTHER|Mixed-effects Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod. MMRM included'baseline' as a continuous covariate, and 'visit', 'treatment', 'region' (stratification according to Japan vs. non-Japan), 'visit\*treatment' and 'visit\*baseline' interaction as fixed effects as well as the random 'subject' effect. Covariance structure= Unstructured.|Difference of adjusted means|-4.1|STANDARD_ERROR_OF_MEAN|6.9||0.5595|TWO_SIDED|95.0|-17.7|9.6|||Mixed Models Analysis|Kenward-Roger was used to estimate denominator degrees of freedom.|Difference was calculated as Speso - placebo.|||9.6|-17.7|0.5595
72596735|NCT04015518|144724774|OTHER|Mixed-effects Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod. MMRM included'baseline' as a continuous covariate, and 'visit', 'treatment', 'region' (stratification according to Japan vs. non-Japan), 'visit\*treatment' and 'visit\*baseline' interaction as fixed effects as well as the random 'subject' effect. Covariance structure= Unstructured.|Difference of adjusted means|0.9|STANDARD_ERROR_OF_MEAN|6.9||0.8968|TWO_SIDED|95.0|-12.7|14.5|||Mixed Models Analysis|Kenward-Roger was used to estimate denominator degrees of freedom.|Difference was calculated as Speso - placebo.|||14.5|-12.7|0.8968
72596736|NCT04015518|144724774|OTHER|Mixed-effects Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod. MMRM included'baseline' as a continuous covariate, and 'visit', 'treatment', 'region' (stratification according to Japan vs. non-Japan), 'visit\*treatment' and 'visit\*baseline' interaction as fixed effects as well as the random 'subject' effect. Covariance structure= Unstructured.|Difference of adjusted means|-4.2|STANDARD_ERROR_OF_MEAN|6.9||0.5456|TWO_SIDED|95.0|-17.9|9.5|||Mixed Models Analysis|Kenward-Roger was used to estimate denominator degrees of freedom.|Difference was calculated as Speso - placebo.|||9.5|-17.9|0.5456
72415606|NCT00515502|144341935|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.67|STANDARD_ERROR_OF_MEAN|3.516|||TWO_SIDED|95.0|-5.34|8.67|||Mixed Models Analysis|||||8.67|-5.34|
72415607|NCT00515502|144341935|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.83|STANDARD_ERROR_OF_MEAN|4.087|||TWO_SIDED|95.0|-8.97|7.32|||Mixed Models Analysis|||||7.32|-8.97|
72415608|NCT00515502|144341936|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.464|STANDARD_ERROR_OF_MEAN|1.9766|||TWO_SIDED|95.0|-2.492|5.419|||Mixed Models Analysis|||||5.419|-2.492|
72415609|NCT00515502|144341936|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.248|STANDARD_ERROR_OF_MEAN|1.9457|||TWO_SIDED|95.0|-3.647|4.144|||Mixed Models Analysis|||||4.144|-3.647|
72415610|NCT00515502|144341936|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.645|STANDARD_ERROR_OF_MEAN|2.5254|||TWO_SIDED|95.0|-7.687|2.396|||Mixed Models Analysis|||||2.396|-7.687|
72415611|NCT00515502|144341936|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.585|STANDARD_ERROR_OF_MEAN|2.6352|||TWO_SIDED|95.0|-2.671|7.84|||Mixed Models Analysis|||||7.840|-2.671|
72415612|NCT00515502|144341936|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.121|STANDARD_ERROR_OF_MEAN|2.5993|||TWO_SIDED|95.0|-6.308|4.067|||Mixed Models Analysis|||||4.067|-6.308|
72415613|NCT00515502|144341936|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.336|STANDARD_ERROR_OF_MEAN|2.8164|||TWO_SIDED|95.0|-7.952|3.28|||Mixed Models Analysis|||||3.280|-7.952|
72415614|NCT00515502|144341936|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.23|STANDARD_ERROR_OF_MEAN|3.3802|||TWO_SIDED|95.0|-11.96|1.504|||Mixed Models Analysis|||||1.504|-11.96|
72596737|NCT04015518|144724774|OTHER|Mixed-effects Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod. MMRM included'baseline' as a continuous covariate, and 'visit', 'treatment', 'region' (stratification according to Japan vs. non-Japan), 'visit\*treatment' and 'visit\*baseline' interaction as fixed effects as well as the random 'subject' effect. Covariance structure= Unstructured.|Difference of adjusted means|-7.7|STANDARD_ERROR_OF_MEAN|5.7||0.1762|TWO_SIDED|95.0|-19.0|3.5|||Mixed Models Analysis|Kenward-Roger was used to estimate denominator degrees of freedom.|Difference was calculated as Speso - placebo.|||3.5|-19.0|0.1762
72415615|NCT00515502|144341937|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.2|STANDARD_ERROR_OF_MEAN|2.24|||TWO_SIDED|95.0|-9.7|-0.7|||Mixed Models Analysis|||||-0.7|-9.7|
72596738|NCT04015518|144724774|OTHER|Mixed-effects Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod. MMRM included'baseline' as a continuous covariate, and 'visit', 'treatment', 'region' (stratification according to Japan vs. non-Japan), 'visit\*treatment' and 'visit\*baseline' interaction as fixed effects as well as the random 'subject' effect. Covariance structure= Unstructured.||||||0.1726||||||Adjusted for multiplicity.|MCP-Mod linear model fit|||A flat vs. non-flat dose-response relationship across the 4 doses of Spesolimab and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, Emax, exponential, logistic, Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.05).||||0.1726
72596739|NCT04015518|144724774|OTHER|Mixed-effects Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod. MMRM included'baseline' as a continuous covariate, and 'visit', 'treatment', 'region' (stratification according to Japan vs. non-Japan), 'visit\*treatment' and 'visit\*baseline' interaction as fixed effects as well as the random 'subject' effect. Covariance structure= Unstructured.||||||0.2353||||||Adjusted for multiplicity.|MCP-Mod Emax model fit|"Assumed 70% of the maximum effect was achieved at the low dose regimen."||A flat vs. non-flat dose-response relationship across the 4 doses of Spesolimab and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, Emax, exponential, logistic, Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.05).||||0.2353
72596740|NCT04015518|144724774|OTHER|Mixed-effects Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod. MMRM included'baseline' as a continuous covariate, and 'visit', 'treatment', 'region' (stratification according to Japan vs. non-Japan), 'visit\*treatment' and 'visit\*baseline' interaction as fixed effects as well as the random 'subject' effect. Covariance structure= Unstructured.||||||0.1346||||||Adjusted for multiplicity.|MCP-Mod Exponential model fit|"Assumed 25% of the maximum effect was achieved at the medium-low dose regimen."||A flat vs. non-flat dose-response relationship across the 4 doses of Spesolimab and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, Emax, exponential, logistic, Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.05).||||0.1346
72596741|NCT04015518|144724774|OTHER|Mixed-effects Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod. MMRM included'baseline' as a continuous covariate, and 'visit', 'treatment', 'region' (stratification according to Japan vs. non-Japan), 'visit\*treatment' and 'visit\*baseline' interaction as fixed effects as well as the random 'subject' effect. Covariance structure= Unstructured.||||||0.195||||||Adjusted for multiplicity.|MCP-Mod Logistic model fit|"Assumed 20% of maximum effect was achieved at the low dose, 95% of maximum effect was achieved at medium high dose."||A flat vs. non-flat dose-response relationship across the 4 doses of Spesolimab and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, Emax, exponential, logistic, Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.05).||||0.1950
72415616|NCT00515502|144341937|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.6|STANDARD_ERROR_OF_MEAN|2.15|||TWO_SIDED|95.0|-8.9|-0.3|||Mixed Models Analysis|||||-0.3|-8.9|
72415617|NCT00515502|144341937|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.7|STANDARD_ERROR_OF_MEAN|2.91|||TWO_SIDED|95.0|-13.5|-1.8|||Mixed Models Analysis|||||-1.8|-13.5|
72415618|NCT00515502|144341937|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.3|STANDARD_ERROR_OF_MEAN|3.21|||TWO_SIDED|95.0|-11.8|1.1|||Mixed Models Analysis|||||1.1|-11.8|
72415619|NCT00515502|144341937|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|3.12|||TWO_SIDED|95.0|-6.1|6.4|||Mixed Models Analysis|||||6.4|-6.1|
72415620|NCT00515502|144341937|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.7|STANDARD_ERROR_OF_MEAN|3.38|||TWO_SIDED|95.0|-6.1|7.5|||Mixed Models Analysis|||||7.5|-6.1|
72415621|NCT00515502|144341937|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.4|STANDARD_ERROR_OF_MEAN|4.29|||TWO_SIDED|95.0|-10.9|6.2|||Mixed Models Analysis|||||6.2|-10.9|
72596742|NCT04015518|144724774|OTHER|Mixed-effects Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod. MMRM included'baseline' as a continuous covariate, and 'visit', 'treatment', 'region' (stratification according to Japan vs. non-Japan), 'visit\*treatment' and 'visit\*baseline' interaction as fixed effects as well as the random 'subject' effect. Covariance structure= Unstructured.||||||0.1681||||||Adjusted for multiplicity.|MCP-Mod Sigmoid Emax model fit|"Assumed 10% of the maximum effect was achieved at low dose, 80% of the maximum effect was achieved at the medium-high dose."||A flat vs. non-flat dose-response relationship across the 4 doses of Spesolimab and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, Emax, exponential, logistic, Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.05).||||0.1681
72596743|NCT04015518|144724775|OTHER|Mixed-effects Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod. MMRM included'baseline' as a continuous covariate, and 'visit', 'treatment', 'region' (stratification according to Japan vs. non-Japan), 'visit\*treatment' and 'visit\*baseline' interaction as fixed effects as well as the random 'subject' effect. Covariance structure= Unstructured.|Difference of adjusted means|-0.7|STANDARD_ERROR_OF_MEAN|0.6||0.2812|TWO_SIDED|95.0|-1.8|0.5|||Mixed Models Analysis|Kenward-Roger was used to estimate denominator degrees of freedom.|Difference was calculated as Speso - placebo.|||0.5|-1.8|0.2812
72596744|NCT04015518|144724775|OTHER|Mixed-effects Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod. MMRM included'baseline' as a continuous covariate, and 'visit', 'treatment', 'region' (stratification according to Japan vs. non-Japan), 'visit\*treatment' and 'visit\*baseline' interaction as fixed effects as well as the random 'subject' effect. Covariance structure= Unstructured.|Difference of adjusted means|-0.6|STANDARD_ERROR_OF_MEAN|0.6||0.3357|TWO_SIDED|95.0|-1.7|0.6|||Mixed Models Analysis|Kenward-Roger was used to estimate denominator degrees of freedom.|Difference was calculated as Speso - placebo.|||0.6|-1.7|0.3357
72596745|NCT04015518|144724775|OTHER|Mixed-effects Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod. MMRM included'baseline' as a continuous covariate, and 'visit', 'treatment', 'region' (stratification according to Japan vs. non-Japan), 'visit\*treatment' and 'visit\*baseline' interaction as fixed effects as well as the random 'subject' effect. Covariance structure= Unstructured.|Difference of adjusted means|-0.8|STANDARD_ERROR_OF_MEAN|0.6||0.1809|TWO_SIDED|95.0|-2.0|0.4|||Mixed Models Analysis|Kenward-Roger was used to estimate denominator degrees of freedom.|Difference was calculated as Speso - placebo.|||0.4|-2.0|0.1809
72596746|NCT04015518|144724775|OTHER|Mixed-effects Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod. MMRM included'baseline' as a continuous covariate, and 'visit', 'treatment', 'region' (stratification according to Japan vs. non-Japan), 'visit\*treatment' and 'visit\*baseline' interaction as fixed effects as well as the random 'subject' effect. Covariance structure= Unstructured.|Difference of adjusted means|-0.1|STANDARD_ERROR_OF_MEAN|0.5||0.8322|TWO_SIDED|95.0|-1.1|0.9|||Mixed Models Analysis|Kenward-Roger was used to estimate denominator degrees of freedom.|Difference was calculated as Speso - placebo.|||0.9|-1.1|0.8322
72596747|NCT04015518|144724775|OTHER|Mixed-effects Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod. MMRM included'baseline' as a continuous covariate, and 'visit', 'treatment', 'region' (stratification according to Japan vs. non-Japan), 'visit\*treatment' and 'visit\*baseline' interaction as fixed effects as well as the random 'subject' effect. Covariance structure= Unstructured.||||||0.4035||||||Adjusted for multiplicity.|MCP-Mod linear model fit|||A flat vs. non-flat dose-response relationship across the 4 doses of Spesolimab and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, Emax, exponential, logistic, Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.05).||||0.4035
72596748|NCT04015518|144724775|OTHER|Mixed-effects Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod. MMRM included'baseline' as a continuous covariate, and 'visit', 'treatment', 'region' (stratification according to Japan vs. non-Japan), 'visit\*treatment' and 'visit\*baseline' interaction as fixed effects as well as the random 'subject' effect. Covariance structure= Unstructured.||||||0.2563||||||Adjusted for multiplicity.|MCP-Mod Emax model fit|"Assumed 70% of the maximum effect was achieved at the low dose regimen."||A flat vs. non-flat dose-response relationship across the 4 doses of Spesolimab and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, Emax, exponential, logistic, Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.05).||||0.2563
72596749|NCT04015518|144724775|OTHER|Mixed-effects Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod. MMRM included'baseline' as a continuous covariate, and 'visit', 'treatment', 'region' (stratification according to Japan vs. non-Japan), 'visit\*treatment' and 'visit\*baseline' interaction as fixed effects as well as the random 'subject' effect. Covariance structure= Unstructured.||||||0.681||||||Adjusted for multiplicity.|MCP-Mod Exponential model fit|"Assumed 25% of the maximum effect was achieved at the medium-low dose regimen."||A flat vs. non-flat dose-response relationship across the 4 doses of Spesolimab and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, Emax, exponential, logistic, Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.05).||||0.6810
72596750|NCT04015518|144724775|OTHER|Mixed-effects Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod. MMRM included'baseline' as a continuous covariate, and 'visit', 'treatment', 'region' (stratification according to Japan vs. non-Japan), 'visit\*treatment' and 'visit\*baseline' interaction as fixed effects as well as the random 'subject' effect. Covariance structure= Unstructured.||||||0.4665||||||Adjusted for multiplicity.|MCP-Mod Logistic model fit|"Assumed 20% of maximum effect was achieved at the low dose, 95% of maximum effect was achieved at medium high dose."||A flat vs. non-flat dose-response relationship across the 4 doses of Spesolimab and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, Emax, exponential, logistic, Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.05).||||0.4665
72415622|NCT00515502|144341938|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.8|STANDARD_ERROR_OF_MEAN|0.9|||TWO_SIDED|95.0|-3.6|0.0|||Mixed Models Analysis|||||0.0|-3.6|
72596751|NCT04015518|144724775|OTHER|Mixed-effects Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod. MMRM included'baseline' as a continuous covariate, and 'visit', 'treatment', 'region' (stratification according to Japan vs. non-Japan), 'visit\*treatment' and 'visit\*baseline' interaction as fixed effects as well as the random 'subject' effect. Covariance structure= Unstructured.||||||0.5565||||||Adjusted for multiplicity.|MCP-Mod Sigmoid Emax model fit|"Assumed 10% of the maximum effect was achieved at low dose, 80% of the maximum effect was achieved at the medium-high dose."||A flat vs. non-flat dose-response relationship across the 4 doses of Spesolimab and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, Emax, exponential, logistic, Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.05).||||0.5565
72596752|NCT04015518|144724776|OTHER|Logistic regression with fixed classification effects included treatment and region (Japan vs. Non-Japan). In case 0 event are observed a penalized regression based on the Firth's bias reduction method was used. The estimates from the logistic regression are on the logit scale, the difference in proportions were calculated as the difference between the predicted probabilities in the treatment groups on the original scale.|Risk Difference (RD)|0.042|||||TWO_SIDED|95.0|-0.17|0.281|||||Confidence intervals were calculated using the cumulative distribution function method of Reeve. Difference was calculated as Speso - placebo.|||0.281|-0.170|
72596753|NCT04015518|144724776|OTHER|Logistic regression with fixed classification effects included treatment and region (Japan vs. Non-Japan). In case 0 event are observed a penalized regression based on the Firth's bias reduction method was used. The estimates from the logistic regression are on the logit scale, the difference in proportions were calculated as the difference between the predicted probabilities in the treatment groups on the original scale.|Risk Difference (RD)|0.195|||||TWO_SIDED|95.0|-0.048|0.432|||||Confidence intervals were calculated using the cumulative distribution function method of Reeve. Difference was calculated as Speso - placebo.|||0.432|-0.048|
72596754|NCT04015518|144724776|OTHER|Logistic regression with fixed classification effects included treatment and region (Japan vs. Non-Japan). In case 0 event are observed a penalized regression based on the Firth's bias reduction method was used. The estimates from the logistic regression are on the logit scale, the difference in proportions were calculated as the difference between the predicted probabilities in the treatment groups on the original scale.|Risk Difference (RD)|0.27|||||TWO_SIDED|95.0|0.02|0.496|||||Confidence intervals were calculated using the cumulative distribution function method of Reeve. Difference was calculated as Speso - placebo.|||0.496|0.020|
72596755|NCT04015518|144724776|OTHER|Logistic regression with fixed classification effects included treatment and region (Japan vs. Non-Japan). In case 0 event are observed a penalized regression based on the Firth's bias reduction method was used. The estimates from the logistic regression are on the logit scale, the difference in proportions were calculated as the difference between the predicted probabilities in the treatment groups on the original scale.|Risk Difference (RD)|0.129|||||TWO_SIDED|95.0|-0.067|0.314|||||Confidence intervals were calculated using the cumulative distribution function method of Reeve. Difference was calculated as Speso - placebo.|||0.314|-0.067|
72415623|NCT00515502|144341938|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.86|||TWO_SIDED|95.0|-2.0|1.4|||Mixed Models Analysis|||||1.4|-2.0|
72415624|NCT00515502|144341938|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.6|STANDARD_ERROR_OF_MEAN|1.17|||TWO_SIDED|95.0|-3.9|0.8|||Mixed Models Analysis|||||0.8|-3.9|
72415625|NCT00515502|144341938|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0|STANDARD_ERROR_OF_MEAN|1.3|||TWO_SIDED|95.0|-3.6|1.6|||Mixed Models Analysis|||||1.6|-3.6|
72415626|NCT00515502|144341938|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8|STANDARD_ERROR_OF_MEAN|1.26|||TWO_SIDED|95.0|-3.3|1.7|||Mixed Models Analysis|||||1.7|-3.3|
72596756|NCT04015518|144724776|OTHER|Logistic regression estimates were used as input for the MCP-Mod, with fixed classification effects including treatment and region (Japan vs. Non-Japan). In case 0 event are observed a penalized regression based on the Firth's bias reduction method was used. The estimates from the logistic regression are on the logit scale, the difference in proportions were calculated as the difference between the predicted probabilities in the treatment groups on the original scale.||||||0.0613||||||Adjusted for multiplicity.|MCP-Mod linear model fit|||A flat vs. non-flat dose-response relationship across the 4 doses of Spesolimab and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, Emax, exponential, logistic, Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.05).||||0.0613
72596757|NCT04015518|144724776|OTHER|Logistic regression estimates were used as input for the MCP-Mod, with fixed classification effects including treatment and region (Japan vs. Non-Japan). In case 0 event are observed a penalized regression based on the Firth's bias reduction method was used. The estimates from the logistic regression are on the logit scale, the difference in proportions were calculated as the difference between the predicted probabilities in the treatment groups on the original scale.||||||0.0628||||||Adjusted for multiplicity.|MCP-Mod Emax model fit|"Assumed 70% of the maximum effect was achieved at the low dose regimen."||A flat vs. non-flat dose-response relationship across the 4 doses of Spesolimab and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, Emax, exponential, logistic, Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.05).||||0.0628
72596758|NCT04015518|144724776|OTHER|Logistic regression estimates were used as input for the MCP-Mod, with fixed classification effects including treatment and region (Japan vs. Non-Japan). In case 0 event are observed a penalized regression based on the Firth's bias reduction method was used. The estimates from the logistic regression are on the logit scale, the difference in proportions were calculated as the difference between the predicted probabilities in the treatment groups on the original scale.||||||0.1449||||||Adjusted for multiplicity.|MCP-Mod Exponential model fit|"Assumed 25% of the maximum effect was achieved at the medium-low dose regimen."||A flat vs. non-flat dose-response relationship across the 4 doses of Spesolimab and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, Emax, exponential, logistic, Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.05).||||0.1449
72596759|NCT04015518|144724776|OTHER|Logistic regression estimates were used as input for the MCP-Mod, with fixed classification effects including treatment and region (Japan vs. Non-Japan). In case 0 event are observed a penalized regression based on the Firth's bias reduction method was used. The estimates from the logistic regression are on the logit scale, the difference in proportions were calculated as the difference between the predicted probabilities in the treatment groups on the original scale.||||||0.046||||||Adjusted for multiplicity.|MCP-Mod Logistic model fit|"Assumed 20% of maximum effect was achieved at the low dose, 95% of maximum effect was achieved at medium high dose."||A flat vs. non-flat dose-response relationship across the 4 doses of Spesolimab and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, Emax, exponential, logistic, Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.05).||||0.0460
72596760|NCT04015518|144724776|OTHER|Logistic regression estimates were used as input for the MCP-Mod, with fixed classification effects including treatment and region (Japan vs. Non-Japan). In case 0 event are observed a penalized regression based on the Firth's bias reduction method was used. The estimates from the logistic regression are on the logit scale, the difference in proportions were calculated as the difference between the predicted probabilities in the treatment groups on the original scale.||||||0.0677||||||Adjusted for multiplicity.|MCP-Mod Sigmoid Emax model fit|"Assumed 10% of the maximum effect was achieved at low dose, 80% of the maximum effect was achieved at the medium-high dose."||A flat vs. non-flat dose-response relationship across the 4 doses of Spesolimab and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, Emax, exponential, logistic, Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.05).||||0.0677
72415627|NCT00515502|144341938|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.7|STANDARD_ERROR_OF_MEAN|1.37|||TWO_SIDED|95.0|-2.0|3.4|||Mixed Models Analysis|||||3.4|-2.0|
72415628|NCT00515502|144341938|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|1.74|||TWO_SIDED|95.0|-4.1|2.9|||Mixed Models Analysis|||||2.9|-4.1|
72415629|NCT03317002|144341959|SUPERIORITY||Ratio|0.04|||<|0.001|ONE_SIDED|95.0||0.05|||Mixed Models Analysis|||||0.05||<0.001
72415630|NCT03317002|144341959|SUPERIORITY||Ratio|0.08||||0.001|ONE_SIDED|95.0||0.1|||Mixed Models Analysis|||||0.10||0.001
72415631|NCT03317002|144341960|SUPERIORITY||Ratio|0.04|||<|0.001|ONE_SIDED|95.0||0.05|||Mixed Models Analysis|||||0.05||<0.001
72415632|NCT03317002|144341960|SUPERIORITY||Ratio|0.09||||0.001|ONE_SIDED|95.0||0.12|||Mixed Models Analysis|||||0.12||0.001
72415633|NCT05098054|144342025|OTHER||Geometric Least-squares mean(GLSM) Ratio|214.93|||||TWO_SIDED|90.0|103.47|446.45|||||"Geometric least-squares means (LSMs) were calculated by exponentiating the LSMs from the mixed effects model.~Geometric LSM Ratio (GMR) = 100\*(Moderate HI/Normal Hepatic Function (Matched to Moderate HI)"|||446.45|103.47|
72415634|NCT05098054|144342025|OTHER||GLSM Ratio|145.42|||||TWO_SIDED|90.0|77.18|273.98|||||"Geometric LSMs were calculated by exponentiating the LSMs from the mixed effects model.~Geometric LSM Ratio (GMR) = 100\*(Mild HI/Normal Hepatic Function (Matched to Mild HI)"|||273.98|77.18|
72415635|NCT05098054|144342026|OTHER||GLSM Ratio|299.21|||||TWO_SIDED|90.0|111.75|801.17|||||"Geometric LSMs were calculated by exponentiating the LSMs from the mixed effects model.~Geometric LSM Ratio (GMR) = 100\*(Moderate HI/Normal Hepatic Function (Matched to Moderate HI)"|||801.17|111.75|
72415636|NCT05098054|144342026|OTHER||GLSM Ratio|130.25|||||TWO_SIDED|90.0|77.02|220.26|||||"Geometric LSMs were calculated by exponentiating the LSMs from the mixed effects model.~Geometric LSM Ratio (GMR) = 100\*(Mild HI/Normal Hepatic Function (Matched to Mild HI)"|||220.26|77.02|
72415637|NCT05098054|144342027|OTHER||GLSM Ratio|316.27|||||TWO_SIDED|90.0|117.68|849.97|||||"Geometric LSMs were calculated by exponentiating the LSMs from the mixed effects model.~Geometric LSM Ratio (GMR) = 100\*(Moderate HI/Normal Hepatic Function (Matched to Moderate HI)"|||849.97|117.68|
72415638|NCT05098054|144342027|OTHER||GLSM Ratio|135.26|||||TWO_SIDED|90.0|91.22|200.57|||||"Geometric LSMs were calculated by exponentiating the LSMs from the mixed effects model.~Geometric LSM Ratio (GMR) = 100\*(Mild HI/Normal Hepatic Function (Matched to Mild HI)"|||200.57|91.22|
72596761|NCT04015518|144724777|OTHER|Logistic regression with fixed classification effects included treatment and region (Japan vs. Non-Japan). In case 0 event are observed a penalized regression based on the Firth's bias reduction method was used. The estimates from the logistic regression are on the logit scale, the difference in proportions were calculated as the difference between the predicted probabilities in the treatment groups on the original scale.|Risk Difference (RD)|0.063|||||TWO_SIDED|95.0|-0.069|0.256|||||Confidence intervals were calculated using the cumulative distribution function method of Reeve. Difference was calculated as Speso - placebo.|||0.256|-0.069|
72596762|NCT04015518|144724777|OTHER|Logistic regression with fixed classification effects included treatment and region (Japan vs. Non-Japan). In case 0 event are observed a penalized regression based on the Firth's bias reduction method was used. The estimates from the logistic regression are on the logit scale, the difference in proportions were calculated as the difference between the predicted probabilities in the treatment groups on the original scale.|Risk Difference (RD)|0.188|||||TWO_SIDED|95.0|0.018|0.405|||||Confidence intervals were calculated using the cumulative distribution function method of Reeve. Difference was calculated as Speso - placebo.|||0.405|0.018|
72596763|NCT04015518|144724777|OTHER|Logistic regression with fixed classification effects included treatment and region (Japan vs. Non-Japan). In case 0 event are observed a penalized regression based on the Firth's bias reduction method was used. The estimates from the logistic regression are on the logit scale, the difference in proportions were calculated as the difference between the predicted probabilities in the treatment groups on the original scale.|Risk Difference (RD)|0.102|||||TWO_SIDED|95.0|-0.042|0.303|||||Confidence intervals were calculated using the cumulative distribution function method of Reeve. Difference was calculated as Speso - placebo.|||0.303|-0.042|
72596764|NCT04015518|144724777|OTHER|Logistic regression with fixed classification effects included treatment and region (Japan vs. Non-Japan). In case 0 event are observed a penalized regression based on the Firth's bias reduction method was used. The estimates from the logistic regression are on the logit scale, the difference in proportions were calculated as the difference between the predicted probabilities in the treatment groups on the original scale.|Risk Difference (RD)|0.113|||||TWO_SIDED|95.0|-0.018|0.25|||||Confidence intervals were calculated using the cumulative distribution function method of Reeve. Difference was calculated as Speso - placebo.|||0.250|-0.018|
72596765|NCT04015518|144724777|OTHER|Logistic regression estimates were used as input for the MCP-Mod, with fixed classification effects including treatment and region (Japan vs. Non-Japan). In case 0 event are observed a penalized regression based on the Firth's bias reduction method was used. The estimates from the logistic regression are on the logit scale, the difference in proportions were calculated as the difference between the predicted probabilities in the treatment groups on the original scale.||||||0.0536||||||Adjusted for multiplicity.|MCP-Mod linear model fit|||A flat vs. non-flat dose-response relationship across the 4 doses of Spesolimab and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, Emax, exponential, logistic, Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.05).||||0.0536
72596766|NCT04015518|144724777|OTHER|Logistic regression estimates were used as input for the MCP-Mod, with fixed classification effects including treatment and region (Japan vs. Non-Japan). In case 0 event are observed a penalized regression based on the Firth's bias reduction method was used. The estimates from the logistic regression are on the logit scale, the difference in proportions were calculated as the difference between the predicted probabilities in the treatment groups on the original scale.||||||0.0476||||||Adjusted for multiplicity.|MCP-Mod Emax model fit|"Assumed 70% of the maximum effect was achieved at the low dose regimen."||A flat vs. non-flat dose-response relationship across the 4 doses of Spesolimab and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, Emax, exponential, logistic, Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.05).||||0.0476
72415639|NCT01426191|144342029|OTHER|||||||0.05|||||||Fisher Exact|||||||0.05
72415640|NCT01426191|144342030|OTHER|||||||0.01|||||||Fisher Exact|||||||0.01
72415641|NCT02013622|144342031|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Mixed Models Analysis|Mixed model repeated measures (MMRM) method with model terms: baseline, visit, and baseline by visit interaction.||The null hypothesis of zero in mean change from Baseline in PANSS Total Score at Week 16 was tested at significance level of 0.05. Since this is an exploratory trial, no methods to control type I error rate were performed.||||<0.0001
72415642|NCT02013622|144342032|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Mixed Models Analysis|MMRM method with model terms: baseline, visit, and baseline by visit interaction.||Statistical analysis at Week 16||||<0.0001
72415643|NCT02013622|144342033|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Mixed Models Analysis|MMRM method with model terms: baseline, visit, and baseline by visit interaction.||Statistical analysis at Week 16||||<0.0001
72415644|NCT02013622|144342036|SUPERIORITY_OR_OTHER|||||||0.0003|TWO_SIDED||||||Mixed Models Analysis|MMRM method with model terms: baseline, visit, and baseline by visit interaction.||Statistical analysis at Week 16||||0.0003
72415645|NCT02013622|144342037|SUPERIORITY_OR_OTHER|||||||0.0002|TWO_SIDED||||||Mixed Models Analysis|MMRM method with model terms: baseline, visit, and baseline by visit interaction.||Statistical analysis at Week 16||||0.0002
72596767|NCT04015518|144724777|OTHER|Logistic regression estimates were used as input for the MCP-Mod, with fixed classification effects including treatment and region (Japan vs. Non-Japan). In case 0 event are observed a penalized regression based on the Firth's bias reduction method was used. The estimates from the logistic regression are on the logit scale, the difference in proportions were calculated as the difference between the predicted probabilities in the treatment groups on the original scale.||||||0.1076||||||Adjusted for multiplicity.|MCP-Mod Exponential model fit|"Assumed 25% of the maximum effect was achieved at the medium-low dose regimen."||A flat vs. non-flat dose-response relationship across the 4 doses of Spesolimab and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, Emax, exponential, logistic, Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.05).||||0.1076
72596768|NCT04015518|144724777|OTHER|Logistic regression estimates were used as input for the MCP-Mod, with fixed classification effects including treatment and region (Japan vs. Non-Japan). In case 0 event are observed a penalized regression based on the Firth's bias reduction method was used. The estimates from the logistic regression are on the logit scale, the difference in proportions were calculated as the difference between the predicted probabilities in the treatment groups on the original scale.||||||0.0606||||||Adjusted for multiplicity.|MCP-Mod Logistic model fit|"Assumed 20% of maximum effect was achieved at the low dose, 95% of maximum effect was achieved at medium high dose."||A flat vs. non-flat dose-response relationship across the 4 doses of Spesolimab and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, Emax, exponential, logistic, Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.05).||||0.0606
72596769|NCT04015518|144724777|OTHER|Logistic regression estimates were used as input for the MCP-Mod, with fixed classification effects including treatment and region (Japan vs. Non-Japan). In case 0 event are observed a penalized regression based on the Firth's bias reduction method was used. The estimates from the logistic regression are on the logit scale, the difference in proportions were calculated as the difference between the predicted probabilities in the treatment groups on the original scale.||||||0.0824||||||Adjusted for multiplicity.|MCP-Mod Sigmoid Emax model fit|"Assumed 10% of the maximum effect was achieved at low dose, 80% of the maximum effect was achieved at the medium-high dose."||A flat vs. non-flat dose-response relationship across the 4 doses of Spesolimab and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, Emax, exponential, logistic, Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.05).||||0.0824
72596770|NCT04015518|144724778|OTHER|Logistic regression with fixed classification effects included treatment and region (Japan vs. Non-Japan). In case 0 event are observed a penalized regression based on the Firth's bias reduction method was used. The estimates from the logistic regression are on the logit scale, the difference in proportions were calculated as the difference between the predicted probabilities in the treatment groups on the original scale.|Risk Difference (RD)|0.211|||||TWO_SIDED|95.0|0.04|0.422|||||Confidence intervals were calculated using the cumulative distribution function method of Reeve. Difference was calculated as Speso - placebo.|||0.422|0.040|
72596771|NCT04015518|144724778|OTHER|Logistic regression with fixed classification effects included treatment and region (Japan vs. Non-Japan). In case 0 event are observed a penalized regression based on the Firth's bias reduction method was used. The estimates from the logistic regression are on the logit scale, the difference in proportions were calculated as the difference between the predicted probabilities in the treatment groups on the original scale.|Risk Difference (RD)|0.13|||||TWO_SIDED|95.0|-0.018|0.339|||||Confidence intervals were calculated using the cumulative distribution function method of Reeve. Difference was calculated as Speso - placebo.|||0.339|-0.018|
72596772|NCT04015518|144724778|OTHER|Logistic regression with fixed classification effects included treatment and region (Japan vs. Non-Japan). In case 0 event are observed a penalized regression based on the Firth's bias reduction method was used. The estimates from the logistic regression are on the logit scale, the difference in proportions were calculated as the difference between the predicted probabilities in the treatment groups on the original scale.|Risk Difference (RD)|0.125|||||TWO_SIDED|95.0|-0.022|0.328|||||Confidence intervals were calculated using the cumulative distribution function method of Reeve. Difference was calculated as Speso - placebo.|||0.328|-0.022|
72596773|NCT04015518|144724778|OTHER|Logistic regression with fixed classification effects included treatment and region (Japan vs. Non-Japan). In case 0 event are observed a penalized regression based on the Firth's bias reduction method was used. The estimates from the logistic regression are on the logit scale, the difference in proportions were calculated as the difference between the predicted probabilities in the treatment groups on the original scale.|Risk Difference (RD)|0.144|||||TWO_SIDED|95.0|0.009|0.282|||||Confidence intervals were calculated using the cumulative distribution function method of Reeve. Difference was calculated as Speso - placebo.|||0.282|0.009|
72415646|NCT02013622|144342038|SUPERIORITY_OR_OTHER|||||||0.0177|TWO_SIDED||||||Mixed Models Analysis|MMRM method with model terms: baseline, visit, and baseline by visit interaction.||Statistical analysis at Week 16||||0.0177
72596774|NCT04015518|144724778|OTHER|Logistic regression estimates were used as input for the MCP-Mod, with fixed classification effects including treatment and region (Japan vs. Non-Japan). In case 0 event are observed a penalized regression based on the Firth's bias reduction method was used. The estimates from the logistic regression are on the logit scale, the difference in proportions were calculated as the difference between the predicted probabilities in the treatment groups on the original scale.||||||0.0333||||||Adjusted for multiplicity.|MCP-Mod linear model fit|||A flat vs. non-flat dose-response relationship across the 4 doses of Spesolimab and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, Emax, exponential, logistic, Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.05).||||0.0333
72596775|NCT04015518|144724778|OTHER|Logistic regression estimates were used as input for the MCP-Mod, with fixed classification effects including treatment and region (Japan vs. Non-Japan). In case 0 event are observed a penalized regression based on the Firth's bias reduction method was used. The estimates from the logistic regression are on the logit scale, the difference in proportions were calculated as the difference between the predicted probabilities in the treatment groups on the original scale.||||||0.0221||||||Adjusted for multiplicity.|MCP-Mod Emax model fit|"Assumed 70% of the maximum effect was achieved at the low dose regime"||A flat vs. non-flat dose-response relationship across the 4 doses of Spesolimab and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, Emax, exponential, logistic, Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.05).||||0.0221
72596776|NCT04015518|144724778|OTHER|Logistic regression estimates were used as input for the MCP-Mod, with fixed classification effects including treatment and region (Japan vs. Non-Japan). In case 0 event are observed a penalized regression based on the Firth's bias reduction method was used. The estimates from the logistic regression are on the logit scale, the difference in proportions were calculated as the difference between the predicted probabilities in the treatment groups on the original scale.||||||0.0707||||||Adjusted for multiplicity.|MCP-Mod Exponential model fit|"Assumed 25% of the maximum effect was achieved at the medium-low dose regimen."||A flat vs. non-flat dose-response relationship across the 4 doses of Spesolimab and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, Emax, exponential, logistic, Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.05).||||0.0707
72596777|NCT04015518|144724778|OTHER|Logistic regression estimates were used as input for the MCP-Mod, with fixed classification effects including treatment and region (Japan vs. Non-Japan). In case 0 event are observed a penalized regression based on the Firth's bias reduction method was used. The estimates from the logistic regression are on the logit scale, the difference in proportions were calculated as the difference between the predicted probabilities in the treatment groups on the original scale.||||||0.0578||||||Adjusted for multiplicity.|MCP-Mod Logistic model fit|"Assumed 20% of maximum effect was achieved at the low dose, 95% of maximum effect was achieved at medium high dose."||A flat vs. non-flat dose-response relationship across the 4 doses of Spesolimab and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, Emax, exponential, logistic, Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.05).||||0.0578
72596778|NCT04015518|144724778|OTHER|Logistic regression estimates were used as input for the MCP-Mod, with fixed classification effects including treatment and region (Japan vs. Non-Japan). In case 0 event are observed a penalized regression based on the Firth's bias reduction method was used. The estimates from the logistic regression are on the logit scale, the difference in proportions were calculated as the difference between the predicted probabilities in the treatment groups on the original scale.||||||0.0771||||||Adjusted for multiplicity.|MCP-Mod Sigmoid Emax model fit|"Assumed 10% of the maximum effect was achieved at low dose, 80% of the maximum effect was achieved at the medium-high dose."||A flat vs. non-flat dose-response relationship across the 4 doses of Spesolimab and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, Emax, exponential, logistic, Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.05).||||0.0771
72596779|NCT04015518|144724779|OTHER|Logistic regression with fixed classification effects included treatment and region (Japan vs. Non-Japan). In case 0 event are observed a penalized regression based on the Firth's bias reduction method was used. The estimates from the logistic regression are on the logit scale, the difference in proportions were calculated as the difference between the predicted probabilities in the treatment groups on the original scale.|Risk Difference (RD)|0.202|||||TWO_SIDED|95.0|-0.005|0.427|||||Confidence intervals were calculated using the cumulative distribution function method of Reeve. Difference was calculated as Speso - placebo.|||0.427|-0.005|
72415647|NCT02013622|144342039|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Mixed Models Analysis|MMRM method with model terms: baseline, visit, and baseline by visit interaction.||Statistical analysis at Week 16 in TSQM-14 effectiveness||||<0.0001
72415648|NCT02013622|144342039|SUPERIORITY_OR_OTHER|||||||0.0031|TWO_SIDED||||||Mixed Models Analysis|MMRM method with model terms: baseline, visit, and baseline by visit interaction.||Statistical analysis at Week 16 in TSQM-14 side effects||||0.0031
72415649|NCT02013622|144342039|SUPERIORITY_OR_OTHER|||||||0.0005|TWO_SIDED||||||Mixed Models Analysis|MMRM method with model terms: baseline, visit, and baseline by visit interaction.||Statistical analysis at Week 16 in TSQM-14 convenience||||0.0005
72596780|NCT04015518|144724779|OTHER|Logistic regression with fixed classification effects included treatment and region (Japan vs. Non-Japan). In case 0 event are observed a penalized regression based on the Firth's bias reduction method was used. The estimates from the logistic regression are on the logit scale, the difference in proportions were calculated as the difference between the predicted probabilities in the treatment groups on the original scale.|Risk Difference (RD)|0.17|||||TWO_SIDED|95.0|-0.032|0.401|||||Confidence intervals were calculated using the cumulative distribution function method of Reeve. Difference was calculated as Speso - placebo.|||0.401|-0.032|
72596781|NCT04015518|144724779|OTHER|Logistic regression with fixed classification effects included treatment and region (Japan vs. Non-Japan). In case 0 event are observed a penalized regression based on the Firth's bias reduction method was used. The estimates from the logistic regression are on the logit scale, the difference in proportions were calculated as the difference between the predicted probabilities in the treatment groups on the original scale.|Risk Difference (RD)|0.248|||||TWO_SIDED|95.0|0.032|0.471|||||Confidence intervals were calculated using the cumulative distribution function method of Reeve. Difference was calculated as Speso - placebo.|||0.471|0.032|
72596782|NCT04015518|144724779|OTHER|Logistic regression with fixed classification effects included treatment and region (Japan vs. Non-Japan). In case 0 event are observed a penalized regression based on the Firth's bias reduction method was used. The estimates from the logistic regression are on the logit scale, the difference in proportions were calculated as the difference between the predicted probabilities in the treatment groups on the original scale.|Risk Difference (RD)|0.202|||||TWO_SIDED|95.0|0.024|0.367|||||Confidence intervals were calculated using the cumulative distribution function method of Reeve. Difference was calculated as Speso - placebo.|||0.367|0.024|
72596783|NCT04015518|144724779|OTHER|Logistic regression estimates were used as input for the MCP-Mod, with fixed classification effects including treatment and region (Japan vs. Non-Japan). In case 0 event are observed a penalized regression based on the Firth's bias reduction method was used. The estimates from the logistic regression are on the logit scale, the difference in proportions were calculated as the difference between the predicted probabilities in the treatment groups on the original scale.||||||0.0158||||||Adjusted for multiplicity.|MCP-Mod linear model fit|||A flat vs. non-flat dose-response relationship across the 4 doses of Spesolimab and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, Emax, exponential, logistic, Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.05).||||0.0158
72596784|NCT04015518|144724779|OTHER|Logistic regression estimates were used as input for the MCP-Mod, with fixed classification effects including treatment and region (Japan vs. Non-Japan). In case 0 event are observed a penalized regression based on the Firth's bias reduction method was used. The estimates from the logistic regression are on the logit scale, the difference in proportions were calculated as the difference between the predicted probabilities in the treatment groups on the original scale.||||||0.012||||||Adjusted for multiplicity.|MCP-Mod Emax model fit|"Assumed 70% of the maximum effect was achieved at the low dose regimen."||A flat vs. non-flat dose-response relationship across the 4 doses of Spesolimab and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, Emax, exponential, logistic, Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.05).||||0.0120
72596785|NCT04015518|144724779|OTHER|Logistic regression estimates were used as input for the MCP-Mod, with fixed classification effects including treatment and region (Japan vs. Non-Japan). In case 0 event are observed a penalized regression based on the Firth's bias reduction method was used. The estimates from the logistic regression are on the logit scale, the difference in proportions were calculated as the difference between the predicted probabilities in the treatment groups on the original scale.||||||0.0429||||||Adjusted for multiplicity.|MCP-Mod Exponential model fit|"Assumed 25% of the maximum effect was achieved at the medium-low dose regimen."||A flat vs. non-flat dose-response relationship across the 4 doses of Spesolimab and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, Emax, exponential, logistic, Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.05).||||0.0429
72596786|NCT04015518|144724779|OTHER|Logistic regression estimates were used as input for the MCP-Mod, with fixed classification effects including treatment and region (Japan vs. Non-Japan). In case 0 event are observed a penalized regression based on the Firth's bias reduction method was used. The estimates from the logistic regression are on the logit scale, the difference in proportions were calculated as the difference between the predicted probabilities in the treatment groups on the original scale.||||||0.0229||||||Adjusted for multiplicity.|MCP-Mod Logistic model fit|"Assumed 20% of maximum effect was achieved at the low dose, 95% of maximum effect was achieved at medium high dose."||A flat vs. non-flat dose-response relationship across the 4 doses of Spesolimab and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, Emax, exponential, logistic, Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.05).||||0.0229
72596787|NCT04015518|144724779|OTHER|Logistic regression estimates were used as input for the MCP-Mod, with fixed classification effects including treatment and region (Japan vs. Non-Japan). In case 0 event are observed a penalized regression based on the Firth's bias reduction method was used. The estimates from the logistic regression are on the logit scale, the difference in proportions were calculated as the difference between the predicted probabilities in the treatment groups on the original scale.||||||0.03||||||Adjusted for multiplicity.|MCP-Mod Sigmoid Emax model fit|"Assumed 10% of the maximum effect was achieved at low dose, 80% of the maximum effect was achieved at the medium-high dose."||A flat vs. non-flat dose-response relationship across the 4 doses of Spesolimab and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, Emax, exponential, logistic, Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.05).||||0.0300
72415650|NCT02013622|144342039|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Mixed Models Analysis|MMRM method with model terms: baseline, visit, and baseline by visit interaction.||Statistical analysis at Week 16 in TSQM-14 global satisfaction||||<0.0001
72415651|NCT02013622|144342040|SUPERIORITY_OR_OTHER|||||||0.5133|TWO_SIDED||||||t-test, 2 sided|||Statistical analysis at Week 16 in Go/No-go task p-inhibition failures (go cues)||||0.5133
72596788|NCT04015518|144724780|OTHER|MMRM included 'baseline' as a continuous covariate, and 'visit', 'treatment', 'region' (stratification according to Japan vs. non-Japan), 'visit\*treatment' and 'visit\*baseline' interaction as fixed effects as well as the random 'subject' effect. Covariance structure= Unstructured.|Difference of adjusted means|-18.7|STANDARD_ERROR_OF_MEAN|9.3|||TWO_SIDED|95.0|-37.2|-0.2|||||Difference was calculated as Speso - placebo.|||-0.2|-37.2|
72596789|NCT04015518|144724780|OTHER|MMRM included 'baseline' as a continuous covariate, and 'visit', 'treatment', 'region' (stratification according to Japan vs. non-Japan), 'visit\*treatment' and 'visit\*baseline' interaction as fixed effects as well as the random 'subject' effect. Covariance structure= Unstructured.|Difference of adjusted means|-19.3|STANDARD_ERROR_OF_MEAN|9.6|||TWO_SIDED|95.0|-38.3|-0.2|||||Difference was calculated as Speso - placebo.|||-0.2|-38.3|
72596790|NCT04015518|144724780|OTHER|MMRM included 'baseline' as a continuous covariate, and 'visit', 'treatment', 'region' (stratification according to Japan vs. non-Japan), 'visit\*treatment' and 'visit\*baseline' interaction as fixed effects as well as the random 'subject' effect. Covariance structure= Unstructured.|Difference of adjusted means|-26.6|STANDARD_ERROR_OF_MEAN|9.5|||TWO_SIDED|95.0|-45.5|-7.8|||||Difference was calculated as Speso - placebo.|||-7.8|-45.5|
72596791|NCT04015518|144724780|OTHER|MMRM included 'baseline' as a continuous covariate, and 'visit', 'treatment', 'region' (stratification according to Japan vs. non-Japan), 'visit\*treatment' and 'visit\*baseline' interaction as fixed effects as well as the random 'subject' effect. Covariance structure= Unstructured.|Difference of adjusted means|-5.4|STANDARD_ERROR_OF_MEAN|7.9|||TWO_SIDED|95.0|-21.1|10.2|||||Difference was calculated as Speso - placebo.|||10.2|-21.1|
72596792|NCT02195427|144724781|NON_INFERIORITY|"A WSRS change of 1 grade is considered to be clinically significant. A difference of ≤0.5 grade between the two treatment groups (i.e., half of the clinically significant difference) = non-inferiority margin.~The primary efficacy endpoint uses a paired-design and is analyzed by calculating two-sided confidence intervals of the mean difference between TEOSYAL® RHA Global Action and the control device, between the V1 enrollment visit (baseline) and V7 (24 weeks after baseline)."|Mean Difference (Final Values)|-0.03|||||TWO_SIDED|97.5|-0.17|0.11|||||The decision is based on the upper limit of the 2-sided confidence interval for the difference for the change from baseline, between test and comparator treatment. For achieving non-inferiority, the upper confidence limit of a 97.5% CI must be ≤0.5|"Efficacy of TEOSYAL® RHA Global Action versus control is analyzed in a non-inferiority statistical model using the 5-grade Wrinkle Severity Rating Scale (WSRS) as rated by the Blinded Live Evaluator at 24 weeks after baseline.~The primary endpoint is the aesthetic improvement from pre-injection of the NLF at the side of the face treated with TEOSYAL® RHA Ultra Deep compared to the one at the side of the face treated with the control device, as assessed by the BLE at 24 weeks after baseline."||0.11|-0.17|
72596793|NCT02195427|144724781|NON_INFERIORITY|"A WSRS change of 1 grade is considered to be clinically significant. A difference of ≤0.5 grade between the two treatment groups (i.e., half of the clinically significant difference) = non-inferiority margin.~The primary efficacy endpoint uses a paired-design and is analyzed by calculating two-sided confidence intervals of the mean difference between TEOSYAL® RHA Deep Lines and the control device, between the V1 enrollment visit (baseline) and V7 (24 weeks after baseline)."|Mean Difference (Final Values)|-0.1|||||TWO_SIDED|97.5|-0.25|0.06|||||The decision is based on the upper limit of the 2-sided confidence interval for the difference for the change from baseline, between test and comparator treatment. For achieving non-inferiority, the upper confidence limit of a 97.5% CI must be ≤0.5|"Efficacy of TEOSYAL® RHA Deep Lines versus control is analyzed in a non-inferiority statistical model using the 5-grade Wrinkle Severity Rating Scale (WSRS) as rated by the Blinded Live Evaluator at 24 weeks after baseline.~The primary endpoint is the aesthetic improvement from pre-injection of the NLF at the side of the face treated with TEOSYAL® RHA Deep Lines compared to the one at the side of the face treated with the control device, as assessed by the BLE at 24 weeks after baseline"||0.06|-0.25|
72596794|NCT01653327|144724858|SUPERIORITY|||||||0.3198|||||||t-test, 2 sided|||||||0.3198
72596795|NCT01653327|144724859|SUPERIORITY|||||||0.3522|||||||t-test, 2 sided|||||||0.3522
72596796|NCT01738191|144724860|SUPERIORITY|||||||0.25||||||two sided|Global Statistical Test|df=28||The primary comparison between ATM and placebo used O'Brien's Global Statistical Test (GST) to analyze change from baseline to 10 weeks for the set of neuropsychological measures included in the primary efficacy outcome.||||0.25
72415652|NCT02013622|144342040|SUPERIORITY_OR_OTHER|||||||0.3774|TWO_SIDED||||||t-test, 2 sided|||Statistical analysis at Week 16 in Go/No-go task p-inhibition failures (no-go cues)||||0.3774
72415653|NCT02013622|144342041|SUPERIORITY_OR_OTHER|||||||0.8897|TWO_SIDED||||||t-test, 2 sided|||Statistical analysis at Week 16 in Go/No-go task mean reaction time (go cues)||||0.8897
72415654|NCT02013622|144342041|SUPERIORITY_OR_OTHER|||||||0.3401|TWO_SIDED||||||t-test, 2 sided|||Statistical analysis at Week 16 in Go/No-go task mean reaction time (no-go cues)||||0.3401
72415655|NCT02013622|144342042|SUPERIORITY_OR_OTHER|||||||0.4265|TWO_SIDED||||||t-test, 2 sided|||Statistical analysis at Week 16 in DDT||||0.4265
72596797|NCT04607980|144724868|EQUIVALENCE|Clinical equivalence of the primary endpoint was evaluated by comparing the 2-sided 95% confidence interval (CI) of the mean difference of PASI percent improvement from Baseline to Week 12 between ABP 654 versus (vs) ustekinumab with an equivalence margin of (-15, +15).|Mean Difference (Final Values)|0.14|||||TWO_SIDED|95.0|-3.16|3.43||||||Multiple imputation was applied for the point estimate and CI of the mean difference between the 2 groups.||3.43|-3.16|
72596798|NCT04607980|144724869|EQUIVALENCE|The mean differences and 95% CIs of PASI percent improvement between the initial randomized groups (ABP 654 vs ustekinumab) at other scheduled visits was estimated using analysis of covariance (ANCOVA) model adjusted for baseline PASI value, and the stratification factors of prior biologic use for psoriasis, baseline BW group, and geographic region.|Mean Difference (Final Values)|1.95|||||TWO_SIDED|95.0|-2.05|5.94||||||"Week 4: Treatment Group A vs Treatment Group B.~LOCF imputation was used."||5.94|-2.05|
72596799|NCT04607980|144724869|EQUIVALENCE|The mean differences and 95% CIs of PASI percent improvement between the initial randomized groups (ABP 654 vs ustekinumab) at other scheduled visits was estimated using ANCOVA model adjusted for baseline PASI value, and the stratification factors of prior biologic use for psoriasis, baseline BW group, and geographic region.|Mean Difference (Final Values)|0.17|||||TWO_SIDED|95.0|-2.97|3.31||||||"Week 16: Treatment Group A vs Treatment Group B.~LOCF imputation was used."||3.31|-2.97|
72596800|NCT04607980|144724869|EQUIVALENCE|The mean differences and 95% CIs of PASI percent improvement between the initial randomized groups (ABP 654 vs ustekinumab) at other scheduled visits was estimated using ANCOVA model adjusted for baseline PASI value, and the stratification factors of prior biologic use for psoriasis, baseline BW group, and geographic region.|Mean Difference (Final Values)|1.34|||||TWO_SIDED|95.0|-1.39|4.07||||||"Week 28: Treatment Group A vs Treatment Group B.~LOCF imputation was used."||4.07|-1.39|
72596801|NCT04607980|144724869|EQUIVALENCE|The mean differences and 95% CIs of PASI percent improvement between the dose intensification groups (ABP 654 vs ustekinumab) at other scheduled visits was estimated using ANCOVA model adjusted for baseline PASI value, and the stratification factors of prior biologic use for psoriasis, baseline BW group, and geographic region.|Mean Difference (Final Values)|1.26|||||TWO_SIDED|95.0|-5.46|7.98||||||"Week 36: Treatment Group A vs Treatment Group B.~Observed data was used."||7.98|-5.46|
72596802|NCT04607980|144724869|EQUIVALENCE|The mean differences and 95% CIs of PASI percent improvement between the dose intensification groups (ABP 654 vs ustekinumab) at other scheduled visits was estimated using ANCOVA model adjusted for baseline PASI value, and the stratification factors of prior biologic use for psoriasis, baseline BW group, and geographic region.|Mean Difference (Final Values)|-3.71|||||TWO_SIDED|95.0|-10.71|3.28||||||"Week 44: Treatment Group A vs Treatment Group B.~Observed data was used."||3.28|-10.71|
72596803|NCT04607980|144724869|EQUIVALENCE|The mean differences and 95% CIs of PASI percent improvement between the dose intensification groups (ABP 654 vs ustekinumab) at other scheduled visits was estimated using ANCOVA model adjusted for baseline PASI value, and the stratification factors of prior biologic use for psoriasis, baseline BW group, and geographic region.|Mean Difference (Final Values)|-0.66|||||TWO_SIDED|95.0|-8.45|7.13||||||"Week 52: Treatment Group A vs Treatment Group B.~Observed data was used."||7.13|-8.45|
72596804|NCT04607980|144724869|EQUIVALENCE|The differences for the mean percent change from baseline and the corresponding CIs were for ABP 654/ABP 654 minus ustekinumab/ustekinumab. Estimated using ANCOVA model adjusted for baseline PASI value, and the stratification factors of prior biologic use for psoriasis, baseline BW group, and geographic region.|Mean Difference (Final Values)|-1.41|||||TWO_SIDED|95.0|-3.42|0.59||||||"Week 40: ABP 654 vs Ustekinumab.~LOCF imputation was used."||0.59|-3.42|
72415656|NCT02013622|144342043|SUPERIORITY_OR_OTHER|||||||0.2923|TWO_SIDED||||||t-test, 2 sided|||Statistical analysis at Week 16 in DPDT for Delay Discounting Task k value||||0.2923
72596805|NCT04607980|144724869|EQUIVALENCE|The differences for the mean percent change from baseline and the corresponding CIs were for ustekinumab/ABP 654 minus ustekinumab/ustekinumab. Estimated using ANCOVA model adjusted for baseline PASI value, and the stratification factors of prior biologic use for psoriasis, baseline BW group, and geographic region.|Mean Difference (Final Values)|-0.85|||||TWO_SIDED|95.0|-3.17|1.48||||||"Week 40: Ustekinumab/ABP 654 vs Ustekinumab.~LOCF imputation was used."||1.48|-3.17|
72596806|NCT04607980|144724869|EQUIVALENCE|The differences for the mean percent change from baseline and the corresponding CIs were for ABP 654/ABP 654 minus ustekinumab/ustekinumab. Estimated using ANCOVA model adjusted for baseline PASI value, and the stratification factors of prior biologic use for psoriasis, baseline BW group, and geographic region.|Mean Difference (Final Values)|-0.56|||||TWO_SIDED|95.0|-3.29|2.17||||||"Week 52: ABP 654 vs Ustekinumab.~LOCF imputation was used."||2.17|-3.29|
72596807|NCT04607980|144724869|EQUIVALENCE|The differences for the mean percent change from baseline and the corresponding CIs were for ustekinumab/ABP 654 minus ustekinumab/ustekinumab. Estimated using ANCOVA model adjusted for baseline PASI value, and the stratification factors of prior biologic use for psoriasis, baseline BW group, and geographic region.|Mean Difference (Final Values)|0.7|||||TWO_SIDED|95.0|-2.46|3.86||||||"Week 52: Ustekinumab/ABP 654 vs Ustekinumab.~LOCF imputation was used."||3.86|-2.46|
72596808|NCT04607980|144724870|EQUIVALENCE|Response difference (ABP 654 - ustekinumab) was estimated by the Mantel-Haenszel estimate, and the 95% CIs were estimated by the stratified Newcombe confidence limits, adjusting for actual stratification factors of prior biologic use for psoriasis, baseline BW group, and geographic region.|Response difference|1.2|||||TWO_SIDED|95.0|-4.02|6.42||||||"Week 4: Treatment Group A vs Treatment Group B.~NRI was used."||6.42|-4.02|
72415657|NCT02013622|144342043|SUPERIORITY_OR_OTHER|||||||0.9416|TWO_SIDED||||||t-test, 2 sided|||Statistical analysis at Week 16 in DPDT for Probability Discounting Task h value||||0.9416
72415658|NCT02013622|144342044|SUPERIORITY_OR_OTHER|||||||0.1815|TWO_SIDED||||||t-test, 2 sided|||Statistical analysis at Week 16 in DRT||||0.1815
72415659|NCT02013622|144342045|SUPERIORITY_OR_OTHER|||||||0.6648|TWO_SIDED||||||t-test, 2 sided|||Statistical analysis at Week 16 in AUC for food||||0.6648
72415660|NCT02013622|144342045|SUPERIORITY_OR_OTHER|||||||0.9812|TWO_SIDED||||||t-test, 2 sided|||Statistical analysis at Week 16 in AUC for money||||0.9812
72596809|NCT04607980|144724870|EQUIVALENCE|Response difference (ABP 654 - ustekinumab) was estimated by the Mantel-Haenszel estimate, and the 95% CIs were estimated by the stratified Newcombe confidence limits, adjusting for actual stratification factors of prior biologic use for psoriasis, baseline BW group, and geographic region.|Response difference|-0.32|||||TWO_SIDED|95.0|-7.87|7.23||||||"Week 12: Treatment Group A vs Treatment Group B.~NRI was used."||7.23|-7.87|
72415661|NCT02013622|144342047|SUPERIORITY_OR_OTHER|||||||0.0306|TWO_SIDED||||||t-test, 2 sided|||Statistical analysis at Week 16||||0.0306
72415662|NCT04307004|144342058|SUPERIORITY|The threshold for statistical significance was p = 0.05|Mean Difference (Final Values)|0.8|||<|0.0001|TWO_SIDED|95.0|0.5|1.1|||Paired T Test, 2-sided||Mean difference in systolic blood pressure = mean systolic blood pressure when attended - mean systolic blood pressure when not attended (i.e., unattended).|||1.1|0.5|< 0.0001
72596810|NCT04607980|144724870|EQUIVALENCE|Response difference (ABP 654 - ustekinumab) was estimated by the Mantel-Haenszel estimate, and the 95% CIs were estimated by the stratified Newcombe confidence limits, adjusting for actual stratification factors of prior biologic use for psoriasis, baseline BW group, and geographic region.|Response difference|0.82|||||TWO_SIDED|95.0|-5.75|7.37||||||"Week 16: Treatment Group A vs Treatment Group B.~NRI was used."||7.37|-5.75|
72596811|NCT04607980|144724870|EQUIVALENCE|Response difference (ABP 654 - ustekinumab) was estimated by the Mantel-Haenszel estimate, and the 95% CIs were estimated by the stratified Newcombe confidence limits, adjusting for actual stratification factors of prior biologic use for psoriasis, baseline BW group, and geographic region.|Response difference|3.75|||||TWO_SIDED|95.0|-2.37|9.84||||||"Week 28: Treatment Group A vs Treatment Group B.~NRI was used."||9.84|-2.37|
72596812|NCT04607980|144724870|EQUIVALENCE|Response difference in dose intensification participants (ABP 654 - ustekinumab) was estimated by the generalized linear model adjusted for the baseline PASI and the stratification factors with an identity link was used to obtain the point estimate and 95% CI for the risk difference of PASI 75 response rate at each scheduled timepoint.|Response difference|-3.19|||||TWO_SIDED|95.0|-28.15|21.76||||||"Week 36: Treatment Group A vs Treatment Group B.~Observed data was used."||21.76|-28.15|
72596813|NCT04607980|144724870|EQUIVALENCE|Response difference (ABP 654/ABP 654 - ustekinumab/ustekinumab) was estimated by the Mantel-Haenszel estimate, and the 95% CIs were estimated by the stratified Newcombe confidence limits, adjusting for actual stratification factors of prior biologic use for psoriasis, baseline BW group, and geographic region.|Response difference|1.1|||||TWO_SIDED|95.0|-3.74|7.54||||||"Week 40: ABP 654 vs Ustekinumab.~NRI was used."||7.54|-3.74|
72596814|NCT04607980|144724870|EQUIVALENCE|Response difference (ustekinumab/ABP 654 - ustekinumab/ustekinumab) was estimated by the Mantel-Haenszel estimate, and the 95% CIs were estimated by the stratified Newcombe confidence limits, adjusting for actual stratification factors of prior biologic use for psoriasis, baseline BW group, and geographic region.|Response difference|1.85|||||TWO_SIDED|95.0|-4.89|8.39||||||"Week 40: Ustekinumab/ABP 654 vs Ustekinumab.~NRI was used."||8.39|-4.89|
72596815|NCT04607980|144724870|EQUIVALENCE|Response difference (ABP 654/ABP 654 - ustekinumab/ustekinumab) was estimated by the Mantel-Haenszel estimate, and the 95% CIs were estimated by the stratified Newcombe confidence limits, adjusting for actual stratification factors of prior biologic use for psoriasis, baseline BW group, and geographic region.|Response difference|-2.75|||||TWO_SIDED|95.0|-8.61|4.41||||||"Week 52: ABP 654 vs Ustekinumab.~NRI was used."||4.41|-8.61|
72596816|NCT04607980|144724870|EQUIVALENCE|Response difference (ustekinumab/ABP 654 - ustekinumab/ustekinumab) was estimated by the Mantel-Haenszel estimate, and the 95% CIs were estimated by the stratified Newcombe confidence limits, adjusting for actual stratification factors of prior biologic use for psoriasis, baseline BW group, and geographic region.|Response difference|0.14|||||TWO_SIDED|95.0|-7.32|7.43||||||"Week 52: Ustekinumab/ABP 654 vs Ustekinumab.~NRI was used."||7.43|-7.32|
72596817|NCT04607980|144724871|EQUIVALENCE|Response difference (ABP 654 - ustekinumab) was estimated by the Mantel-Haenszel estimate, and the 95% CIs were estimated by the stratified Newcombe confidence limits, adjusting for actual stratification factors of prior biologic use for psoriasis, baseline BW group, and geographic region.|Response difference|-0.34|||||TWO_SIDED|95.0|-3.16|3.21||||||"Week 4: Treatment Group A vs Treatment Group B.~NRI was used."||3.21|-3.16|
72596818|NCT04607980|144724871|EQUIVALENCE|Response difference (ABP 654 - ustekinumab) was estimated by the Mantel-Haenszel estimate, and the 95% CIs were estimated by the stratified Newcombe confidence limits, adjusting for actual stratification factors of prior biologic use for psoriasis, baseline BW group, and geographic region.|Response difference|1.58|||||TWO_SIDED|95.0|-5.03|8.18||||||"Week 12: Treatment Group A vs Treatment Group B.~NRI was used."||8.18|-5.03|
72596819|NCT04607980|144724871|EQUIVALENCE|Response difference (ABP 654 - ustekinumab) was estimated by the Mantel-Haenszel estimate, and the 95% CIs were estimated by the stratified Newcombe confidence limits, adjusting for actual stratification factors of prior biologic use for psoriasis, baseline BW group, and geographic region.|Response difference|3.81|||||TWO_SIDED|95.0|-3.62|11.17||||||"Week 16: Treatment Group A vs Treatment Group B.~NRI was used."||11.17|-3.62|
72596820|NCT04607980|144724871|EQUIVALENCE|Response difference (ABP 654 - ustekinumab) was estimated by the Mantel-Haenszel estimate, and the 95% CIs were estimated by the stratified Newcombe confidence limits, adjusting for actual stratification factors of prior biologic use for psoriasis, baseline BW group, and geographic region.|Response difference|3.07|||||TWO_SIDED|95.0|-4.68|10.78||||||"Week 28: Treatment Group A vs Treatment Group B.~NRI was used."||10.78|-4.68|
72596821|NCT04607980|144724871|EQUIVALENCE|Response difference (ABP 654/ABP 654 - ustekinumab/ustekinumab) was estimated by the Mantel-Haenszel estimate, and the 95% CIs were estimated by the stratified Newcombe confidence limits, adjusting for actual stratification factors of prior biologic use for psoriasis, baseline BW group, and geographic region.|Response difference|-1.93|||||TWO_SIDED|95.0|-12.85|8.89||||||"Week 40: ABP 654 vs Ustekinumab.~NRI was used."||8.89|-12.85|
72596822|NCT04607980|144724871|EQUIVALENCE|Response difference (ustekinumab/ABP 654 - ustekinumab/ustekinumab) was estimated by the Mantel-Haenszel estimate, and the 95% CIs were estimated by the stratified Newcombe confidence limits, adjusting for actual stratification factors of prior biologic use for psoriasis, baseline BW group, and geographic region.|Response difference|-4.93|||||TWO_SIDED|95.0|-17.39|7.73||||||"Week 40: Ustekinumab/ABP 654 vs Ustekinumab.~NRI was used."||7.73|-17.39|
72596823|NCT04607980|144724871|EQUIVALENCE|Response difference (ABP 654/ABP 654 - ustekinumab/ustekinumab) was estimated by the Mantel-Haenszel estimate, and the 95% CIs were estimated by the stratified Newcombe confidence limits, adjusting for actual stratification factors of prior biologic use for psoriasis, baseline BW group, and geographic region.|Response difference|2.55|||||TWO_SIDED|95.0|-8.42|13.3||||||"Week 52: ABP 654 vs Ustekinumab.~NRI was used."||13.30|-8.42|
72415663|NCT04307004|144342058|SUPERIORITY||Mean Difference (Final Values)|0.5|||<|0.0001|TWO_SIDED|95.0|0.3|0.7||The threshold for statistical significance was p = 0.05|Paired T Test, 2-sided||Mean difference in diastolic blood pressure = mean diastolic blood pressure when attended - mean diastolic blood pressure when not attended (i.e., unattended)|||0.7|0.3|< 0.0001
72415664|NCT04307004|144342059|SUPERIORITY||Mean Difference (Final Values)|-2.3|||<|0.0001|TWO_SIDED|95.0|-3.0|-1.5||The threshold for statistical significance was p = 0.05|Paired T Test, 2-sided||Mean difference in systolic blood pressure = mean systolic blood pressure on ambulatory blood pressure monitoring - mean systolic blood pressure on home blood pressure monitoring.|||-1.5|-3.0|< 0.0001
72596824|NCT04607980|144724871|EQUIVALENCE|Response difference (ustekinumab/ABP 654 - ustekinumab/ustekinumab) was estimated by the Mantel-Haenszel estimate, and the 95% CIs were estimated by the stratified Newcombe confidence limits, adjusting for actual stratification factors of prior biologic use for psoriasis, baseline BW group, and geographic region.|Response difference|-2.41|||||TWO_SIDED|95.0|-14.91|10.19||||||"Week 52: Ustekinumab/ABP 654 vs Ustekinumab.~NRI was used."||10.19|-14.91|
72596825|NCT04607980|144724872|EQUIVALENCE|Response difference (ABP 654 - ustekinumab) was estimated by the Mantel-Haenszel estimate, and the 95% CIs were estimated by the stratified Newcombe confidence limits, adjusting for actual stratification factors of prior biologic use for psoriasis, baseline BW group, and geographic region.|Response difference|2.55|||||TWO_SIDED|95.0|-5.65|10.71||||||"Week 12: Treatment Group A vs Treatment Group B.~NRI was used."||10.71|-5.65|
72596826|NCT04607980|144724872|EQUIVALENCE|Response difference (ABP 654/ABP 654 - ustekinumab/ustekinumab) was estimated by the Mantel-Haenszel estimate, and the 95% CIs were estimated by the stratified Newcombe confidence limits, adjusting for actual stratification factors of prior biologic use for psoriasis, baseline BW group, and geographic region.|Response difference|-6.57|||||TWO_SIDED|95.0|-15.41|3.29||||||"Week 52: ABP 654 vs Ustekinumab.~NRI was used."||3.29|-15.41|
72596827|NCT04607980|144724872|EQUIVALENCE|Response difference (ustekinumab/ABP 654 - ustekinumab/ustekinumab) was estimated by the Mantel-Haenszel estimate, and the 95% CIs were estimated by the stratified Newcombe confidence limits, adjusting for actual stratification factors of prior biologic use for psoriasis, baseline BW group, and geographic region.|Response difference|-7.46|||||TWO_SIDED|95.0|-18.41|3.74||||||"Week 52: ABP 654/Ustekinumab vs Ustekinumab.~NRI was used."||3.74|-18.41|
72596828|NCT04607980|144724873|EQUIVALENCE|Mean difference estimated for treatment group A and treatment group B using ANCOVA model adjusted for baseline BSA value, and the stratification factors of prior biologic use for psoriasis, baseline BW group, and geographic region.|Mean Difference (Final Values)|0.47|||||TWO_SIDED|95.0|-1.15|2.1||||||"Week 12: Treatment Group A vs Treatment Group B.~LOCF imputation was used."||2.10|-1.15|
72596829|NCT04607980|144724873|EQUIVALENCE|Mean difference estimated in dose intensification participants (treatment group A and treatment group B) using ANCOVA model adjusted for baseline BSA value, and the stratification factors of prior biologic use for psoriasis, baseline BW group, and geographic region.|Mean Difference (Final Values)|1.39|||||TWO_SIDED|95.0|-0.9|3.67||||||"Week 52: Treatment Group A vs Treatment Group B.~Observed data was used."||3.67|-0.90|
72596830|NCT04607980|144724873|EQUIVALENCE|Mean difference estimated for ABP 654/ ABP 654 and ustekinumab/ ustekinumab using ANCOVA model adjusted for baseline BSA value, and the stratification factors of prior biologic use for psoriasis, baseline BW group, and geographic region.|Mean Difference (Final Values)|-0.13|||||TWO_SIDED|95.0|-0.99|0.74||||||"Week 52: ABP 654 vs Ustekinumab.~LOCF imputation was used."||0.74|-0.99|
72596831|NCT04607980|144724873|EQUIVALENCE|Mean difference estimated for ustekinumab/ABP 654 and ustekinumab/ ustekinumab using ANCOVA model adjusted for baseline BSA value, and the stratification factors of prior biologic use for psoriasis, baseline BW group, and geographic region.|Mean Difference (Final Values)|0.1|||||TWO_SIDED|95.0|-0.9|1.1||||||"Week 52: Ustekinumab/ABP 654 vs Ustekinumab.~LOCF imputation was used."||1.10|-0.90|
72596832|NCT00727090|144724910|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Equivalence|||||<|0.05|||||||t-test, 2 sided|||Null Hypothesis: Change in serum sodium from baseline is not different between groups||||<0.05
72415665|NCT04307004|144342059|SUPERIORITY||Mean Difference (Final Values)|-1.9|||<|0.0001|TWO_SIDED|95.0|-2.5|-1.4||The threshold for statistical significance was p = 0.05|Paired T Test, 2-sided||Mean difference in diastolic blood pressure = mean diastolic blood pressure on ambulatory blood pressure monitoring - mean diastolic blood pressure on home blood pressure monitoring.|||-1.4|-2.5|< 0.0001
72421598|NCT03720938|144354379|SUPERIORITY|||||||0.000235||||||Linear mixed-effects model fit by maximum likelihood since restricted maximum likelihood assumes a strong normality.|Linear mixed-effects model|Adjusted by Satterthwaite's degrees of freedom method for cluster effect, and small sample sizes in addition to baseline value and age.||Null hypothesis was the absence of difference between the two groups for the dependent variable body index z score.||||0.000235
72596833|NCT01066793|144724935|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.527||||0.0211|TWO_SIDED|95.0|0.306|0.908|||Regression, Logistic|||The statistical analysis is presented for Gamma-Glutamyl Transferase (Gamma-GT) in log10 international units per liter (IU/L) at BL. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week \[Wk\]12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.908|0.306|0.0211
72596834|NCT01066793|144724935|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.078|||<|0.0001|TWO_SIDED|95.0|1.065|1.092|||Regression, Logistic|||The statistical analysis is presented for treatment duration after VR in weeks. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.092|1.065|<0.0001
72596835|NCT01066793|144724935|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.22||||0.0053|TWO_SIDED|95.0|1.061|1.403|||Regression, Logistic|||The statistical analysis is presented for cumulative ribavirin dose per 10000 mg, during the first 12 weeks. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.403|1.061|0.0053
72596836|NCT01066793|144724935|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.464||||0.0079|TWO_SIDED|95.0|0.264|0.818|||Regression, Logistic|||The statistical analysis is presented for Platelets x 10\*\*9/L at BL (\< 140 vs \>=180). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.818|0.264|0.0079
72596837|NCT01066793|144724935|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.737||||0.1808|TWO_SIDED|95.0|0.471|1.153|||Regression, Logistic|||The statistical analysis is presented for Platelets x 10\*\*9/L at BL (\>=140 - \< 180 vs \>=180). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.153|0.471|0.1808
72596838|NCT01066793|144724935|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.082|||<|0.0001|TWO_SIDED|95.0|1.069|1.095|||Regression, Logistic|||The statistical analysis is presented for treatment duration after VR in weeks. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.095|1.069|<0.0001
72596839|NCT01066793|144724935|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.676||||0.0005|TWO_SIDED|95.0|0.542|0.844|||Regression, Logistic|||The statistical analysis is presented for Weight per 10 kilogram (kg). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.844|0.542|0.0005
72596840|NCT01066793|144724935|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.573||||0.0041|TWO_SIDED|95.0|0.392|0.838|||Regression, Logistic|||The statistical analysis is presented for HCV RNA at BL in log10 (IU/mL). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.838|0.392|0.0041
72596841|NCT01066793|144724935|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.094|||<|0.0001|TWO_SIDED|95.0|1.048|1.142|||Regression, Logistic|||The statistical analysis is presented for treatment duration after VR in weeks. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.142|1.048|<0.0001
72596842|NCT01066793|144724935|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|7.945||||0.0031|TWO_SIDED|95.0|2.013|31.359|||Regression, Logistic|||The statistical analysis is presented for cumulative PEG-IFN alfa-2a dose per 1000 ug, first 12 weeks. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||31.359|2.013|0.0031
72596843|NCT01066793|144724935|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.9||||0.0012|TWO_SIDED|95.0|0.844|0.959|||Regression, Logistic|||The statistical analysis is presented for body mass index (BMI) in kilogram per square meter (kg/m\^2). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.959|0.844|0.0012
72415666|NCT04307004|144342061|OTHER|Independent variable - Attended systolic blood pressure. Dependent variable - Left ventricular mass index.|beta coefficient|0.43|STANDARD_ERROR_OF_MEAN|0.06|<|0.001|TWO_SIDED|95.0|0.32|0.55|||Regression, Linear|||We determined the association between attended systolic blood pressure and left ventricular mass index (LVMI). This analysis included 587 participants with attended office blood pressure measurements and valid LVMI measurements. This analysis combined across study arms as prespecified in the Study Protocol and Statistical Analysis Plan.||0.55|0.32|< 0.001
72415667|NCT04307004|144342061|OTHER|Independent variable - attended diastolic blood pressure. Dependent variable - left ventricular mass index.|beta coefficient|0.42|STANDARD_ERROR_OF_MEAN|0.09|<|0.001|TWO_SIDED|95.0|0.24|0.6|||Regression, Linear|||We determined the association between attended diastolic blood pressure measurements and left ventricular mass index (LVMI). This analysis included 587 with attended office blood pressure measurements and valid LVMI measurements. This analysis combined across study arms as prespecified in the Study Protocol and Statistical Analysis Plan.||0.60|0.24|< 0.001
72596844|NCT01066793|144724935|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.619||||0.0085|TWO_SIDED|95.0|0.433|0.885|||Regression, Logistic|||The statistical analysis is presented for HCV RNA at BL in log10 (IU/mL). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.885|0.433|0.0085
72596845|NCT01066793|144724935|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.13|||<|0.0001|TWO_SIDED|95.0|1.087|1.174|||Regression, Logistic|||The statistical analysis is presented for treatment duration after VR in weeks. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.174|1.087|<0.0001
72596846|NCT01066793|144724935|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.784||||0.0341|TWO_SIDED|95.0|0.626|0.982|||Regression, Logistic|||The statistical analysis is presented for Weight per 10 kg. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.982|0.626|0.0341
72596847|NCT01066793|144724935|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.575||||0.0443|TWO_SIDED|95.0|0.335|0.986|||Regression, Logistic|||The statistical analysis is presented for aspartate aminotransferase (AST) ratio at BL (\> 1.5 vs \<=1.5). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.986|0.335|0.0443
72596848|NCT01066793|144724935|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.1|||<|0.0001|TWO_SIDED|95.0|1.057|1.144|||Regression, Logistic|||The statistical analysis is presented for treatment duration after VR in weeks. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.144|1.057|<0.0001
72596849|NCT01066793|144724935|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|22.867||||0.0039|TWO_SIDED|95.0|2.73|191.56|||Regression, Logistic|||The statistical analysis is presented for cumulative PEG-IFN alfa-2a dose per 1000 ug, during the first 12 weeks. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||191.56|2.730|0.0039
72415668|NCT04307004|144342061|OTHER|Independent variable - unattended systolic blood pressure. Dependent variable - left ventricular mass index.|beta coefficient|0.44|STANDARD_ERROR_OF_MEAN|0.06|<|0.001|TWO_SIDED|95.0|0.33|0.56|||Regression, Linear|||We determined the association between unattended systolic blood pressure and left ventricular mass index (LVMI). This analysis included 587 participants with unattended office blood pressure measurements and valid LVMI measurements. This analysis combined across study arms as prespecified in the Study Protocol and Statistical Analysis Plan.||0.56|0.33|< 0.001
72596850|NCT01066793|144724935|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.78||||0.0244|TWO_SIDED|95.0|0.628|0.968|||Regression, Logistic|||The statistical analysis is presented for Weight per 10 kg. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a||0.968|0.628|0.0244
72596851|NCT01066793|144724935|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.128|||<|0.0001|TWO_SIDED|95.0|1.086|1.172|||Regression, Logistic|||The statistical analysis is presented for treatment duration after VR in weeks. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.172|1.086|<0.0001
72596852|NCT01066793|144724935|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.547||||0.0453|TWO_SIDED|95.0|0.303|0.987|||Regression, Logistic|||The statistical analysis is presented for HCV RNA at BL in log10 (IU/mL). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2b.||0.987|0.303|0.0453
72596853|NCT01066793|144724935|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.133||||0.0184|TWO_SIDED|95.0|0.025|0.712|||Regression, Logistic|||The statistical analysis is presented for Gamma-GT in log10 (IU/L) at BL. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2b.||0.712|0.025|0.0184
72596854|NCT01066793|144724935|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.103|||<|0.0001|TWO_SIDED|95.0|1.072|1.134|||Regression, Logistic|||The statistical analysis is presented for treatment duration after VR in Weeks. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2b.||1.134|1.072|<0.0001
72596855|NCT01066793|144724935|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.543||||0.0019|TWO_SIDED|95.0|0.37|0.798|||Regression, Logistic|||The statistical analysis is presented for weight per 10 kg. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2b.||0.798|0.370|0.0019
72596856|NCT01066793|144724935|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.359||||0.0017|TWO_SIDED|95.0|0.189|0.679|||Regression, Logistic|||The statistical analysis is presented for HCV RNA at BL in log10 (IU/mL). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2b.||0.679|0.189|0.0017
72596857|NCT01066793|144724935|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.08|||<|0.0001|TWO_SIDED|95.0|1.047|1.114|||Regression, Logistic|||The statistical analysis is presented for treatment duration after VR in weeks. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2b.||1.114|1.047|<0.0001
72596858|NCT01066793|144724935|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.093||||0.0042|TWO_SIDED|95.0|1.029|1.162|||Regression, Logistic|||The statistical analysis is presented for cumulative ribavirin dose per 10000 mg. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2b.||1.162|1.029|0.0042
72596859|NCT01066793|144724935|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.535||||0.0168|TWO_SIDED|95.0|0.32|0.893|||Regression, Logistic|||The statistical analysis is presented for Gamma-GT in log10 (IU/L) at BL. The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.893|0.320|0.0168
72596860|NCT01066793|144724935|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.501||||0.0128|TWO_SIDED|95.0|0.291|0.864|||Regression, Logistic|||The statistical analysis is presented for Platelets x 10\*\*9/L at BL (\< 140 vs \>=180). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.864|0.291|0.0128
72596861|NCT01066793|144724935|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.853||||0.4634|TWO_SIDED|95.0|0.558|1.305|||Regression, Logistic|||The statistical analysis is presented for Platelets x 10\*\*9/L at BL (\>=140 - \< 180 vs \>=180). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.305|0.558|0.4634
72596862|NCT01066793|144724935|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|19.655|||<|0.0001|TWO_SIDED|95.0|9.725|39.722|||Regression, Logistic|||The statistical analysis is presented for On-treatment response (Rapid Virological Response \[RVR\] vs No RVR/EVR \[Early Virological Response\]). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||39.722|9.725|<0.0001
72596863|NCT01066793|144724935|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|8.569|||<|0.0001|TWO_SIDED|95.0|4.408|16.658|||Regression, Logistic|||The statistical analysis is presented for on-treatment response (cEVR \[Complete Early Virological Response\] vs No RVR/EVR). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||16.658|4.408|<0.0001
72596864|NCT01066793|144724935|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.519||||0.0089|TWO_SIDED|95.0|1.26|5.034|||Regression, Logistic|||The statistical analysis is presented for on-treatment response (pEVR \[Partial Early Virological Response\] vs No RVR/EVR). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||5.034|1.260|0.0089
72596865|NCT01066793|144724935|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.908||||0.0037|TWO_SIDED|95.0|0.851|0.969|||Regression, Logistic|||The statistical analysis is presented for BMI in kg/m\^2. The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.969|0.851|0.0037
72596866|NCT01066793|144724935|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.553||||0.002|TWO_SIDED|95.0|0.379|0.805|||Regression, Logistic|||The statistical analysis is presented for HCV RNA at BL in log10 (IU/mL). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.805|0.379|0.0020
72596867|NCT01066793|144724935|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|16.537||||0.0003|TWO_SIDED|95.0|3.654|74.849|||Regression, Logistic|||The statistical analysis is presented for On-treatment response (RVR vs No RVR/EVR). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a||74.849|3.654|0.0003
72596868|NCT01066793|144724935|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.386||||0.0733|TWO_SIDED|95.0|0.87|22.114|||Regression, Logistic|||The statistical analysis is presented for on-treatment response (cEVR vs No RVR/EVR). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||22.114|0.870|0.0733
72596869|NCT01066793|144724935|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.352||||0.3478|TWO_SIDED|95.0|0.394|14.031|||Regression, Logistic|||The statistical analysis is presented for on-treatment response (pEVR vs No RVR/EVR). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||14.031|0.394|0.3478
72596870|NCT01066793|144724935|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.729||||0.0264|TWO_SIDED|95.0|0.552|0.964|||Regression, Logistic|||The statistical analysis is presented for age per 10 years. The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.964|0.552|0.0264
72415669|NCT04307004|144342061|OTHER|Independent variable - unattended diastolic blood pressure. Dependent variable - left ventricular mass index.|beta coefficient|0.37|STANDARD_ERROR_OF_MEAN|0.09|<|0.001|TWO_SIDED|95.0|0.19|0.55|||Regression, Linear|||We determined the association between unattended diastolic blood pressure and left ventricular mass index (LVMI). This analysis included 587 participants with unattended office blood pressure measurements and valid LVMI measurements. This analysis combined across study arms as prespecified in the Study Protocol and Statistical Analysis Plan.||0.55|0.19|< 0.001
72415670|NCT04307004|144342061|OTHER|Independent variable - awake systolic blood pressure on ABPM Dependent variable - left ventricular mass index.|beta coefficient|0.61|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|95.0|0.47|0.74|||Regression, Linear|||We determined the association between awake systolic blood pressure from ambulatory blood pressure monitoring (ABPM) and left ventricular mass index (LVMI). This analysis included 554 participants with out-of-office blood pressure measurements and valid LVMI measurements. This analysis combined across study arms as prespecified in the Study Protocol and Statistical Analysis Plan.||0.74|0.47|< 0.001
72596871|NCT01066793|144724935|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.658||||0.0096|TWO_SIDED|95.0|1.586|27.946|||Regression, Logistic|||The statistical analysis is presented for on-treatment response (RVR vs No RVR/EVR). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||27.946|1.586|0.0096
72415671|NCT04307004|144342061|OTHER|Independent variable - awake diastolic blood pressure on ABPM. Dependent variable - left ventricular mass index.|beta coefficient|0.45|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|0.25|0.66|||Regression, Linear|||We determined the association between awake diastolic blood pressure on ambulatory blood pressure monitoring (ABPM) and left ventricular mass index (LVMI). This analysis included 554 participants with out-of-office blood pressure measurements and valid LVMI measurements. This analysis combined across study arms as prespecified in the Study Protocol and Statistical Analysis Plan.||0.66|0.25|< 0.001
72596872|NCT01066793|144724935|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.734||||0.0421|TWO_SIDED|95.0|1.057|21.203|||Regression, Logistic|||The statistical analysis is presented for on-treatment response (cEVR vs No RVR/EVR). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||21.203|1.057|0.0421
72596873|NCT01066793|144724935|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.602||||0.6004|TWO_SIDED|95.0|0.09|4.014|||Regression, Logistic|||The statistical analysis is presented for on-treatment response (pEVR vs No RVR/EVR). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||4.014|0.090|0.6004
72596874|NCT01066793|144724935|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.715||||0.0418|TWO_SIDED|95.0|0.517|0.988|||Regression, Logistic|||The statistical analysis is presented for age per 10 years. The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2b.||0.988|0.517|0.0418
72596875|NCT01066793|144724935|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.198||||0.0279|TWO_SIDED|95.0|0.047|0.839|||Regression, Logistic|||The statistical analysis is presented for Gamma-GT in log10 (IU/L) at BL. The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2b.||0.839|0.047|0.0279
72596876|NCT01066793|144724935|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|40.88|||<|0.0001|TWO_SIDED|95.0|7.474|223.61|||Regression, Logistic|||The statistical analysis is presented for on-treatment response (RVR vs No RVR/EVR). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2b.||223.61|7.474|<0.0001
72596877|NCT01066793|144724935|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|42.395|||<|0.0001|TWO_SIDED|95.0|8.724|206.02|||Regression, Logistic|||The statistical analysis is presented for on-treatment response (cEVR vs No RVR/EVR). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2b.||206.02|8.724|<0.0001
72596878|NCT01066793|144724935|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|8.247||||0.0087|TWO_SIDED|95.0|1.704|39.908|||Regression, Logistic|||The statistical analysis is presented for on-treatment response (pEVR vs No RVR/EVR). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2b.||39.908|1.704|0.0087
72596879|NCT01066793|144724949|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.957||||0.0002|TWO_SIDED|95.0|1.383|2.77|||Regression, Logistic|||The statistical analysis is presented for HCV RNA at BL in log10 (IU/mL). The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||2.770|1.383|0.0002
72596880|NCT01066793|144724949|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.337||||0.0007|TWO_SIDED|95.0|1.661|6.705|||Regression, Logistic|||The statistical analysis is presented for Platelets x 10\*\*9/L at BL (\< 140 vs \>=180). The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||6.705|1.661|0.0007
72415672|NCT04307004|144342061|OTHER|Independent variable - asleep systolic blood pressure on HBPM. Dependent variable - left ventricular mass index.|beta coefficient|0.31|STANDARD_ERROR_OF_MEAN|0.06|<|0.001|TWO_SIDED|95.0|0.19|0.44|||Regression, Linear|||We determined the association between asleep systolic blood pressure on home blood pressure monitoring (HBPM) and left ventricular mass index (LVMI). This analysis included 533 participants with HBPM data and valid LVMI. This analysis combined across study arms as prespecified in the Study Protocol and Statistical Analysis Plan.||0.44|0.19|< 0.001
72596881|NCT01066793|144724949|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.305||||0.3611|TWO_SIDED|95.0|0.737|2.312|||Regression, Logistic|||The statistical analysis is presented for Platelets x 10\*\*9/L at BL (\>=140 - \< 180 vs \>=180). The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||2.312|0.737|0.3611
72596882|NCT01066793|144724949|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.943|||<|0.0001|TWO_SIDED|95.0|0.929|0.958|||Regression, Logistic|||The statistical analysis is presented for treatment duration after VR in weeks. The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.958|0.929|<0.0001
72596883|NCT01066793|144724949|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.743||||0.002|TWO_SIDED|95.0|0.615|0.897|||Regression, Logistic|||The statistical analysis is presented for cumulative ribavirin dose per 10000 mg, during the first 12 weeks. The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.897|0.615|0.0020
72596884|NCT01066793|144724949|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.864||||0.0004|TWO_SIDED|95.0|1.322|2.628|||Regression, Logistic|||The statistical analysis is presented for HCV RNA at BL in log10 (IU/mL). The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||2.628|1.322|0.0004
72596885|NCT01066793|144724949|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.124||||0.0386|TWO_SIDED|95.0|1.04|4.338|||Regression, Logistic|||The statistical analysis is presented for mode of infection (other vs injection drug U). The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||4.338|1.040|0.0386
72596886|NCT01066793|144724949|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.398||||0.0004|TWO_SIDED|95.0|1.722|6.706|||Regression, Logistic|||The statistical analysis is presented for Platelets x 10\*\*9/L at BL (\< 140 vs \>=180). The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||6.706|1.722|0.0004
72596887|NCT01066793|144724949|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.372||||0.2769|TWO_SIDED|95.0|0.776|2.428|||Regression, Logistic|||The statistical analysis is presented for Platelets x 10\*\*9/L at BL (\>=140 - \< 180 vs \>=180). The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||2.428|0.776|0.2769
72596888|NCT01066793|144724949|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.945|||<|0.0001|TWO_SIDED|95.0|0.931|0.96|||Regression, Logistic|||The statistical analysis is presented for treatment duration after VR in weeks. The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.960|0.931|<0.0001
72596889|NCT01066793|144724949|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.163||||0.0001|TWO_SIDED|95.0|1.078|1.256|||Regression, Logistic|||The statistical analysis is presented for BMI in kg/m\^2. The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.256|1.078|0.0001
72596890|NCT01066793|144724949|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.788||||0.0213|TWO_SIDED|95.0|1.091|2.932|||Regression, Logistic|||The statistical analysis is presented for HCV RNA at BL in log10 (IU/mL). The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||2.932|1.091|0.0213
72596891|NCT01066793|144724949|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.903||||0.0002|TWO_SIDED|95.0|0.856|0.953|||Regression, Logistic|||The statistical analysis is presented for treatment duration after VR in weeks. The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.953|0.856|0.0002
72415673|NCT04307004|144342061|OTHER|Independent variable - asleep diastolic blood pressure on HBPM Dependent variable - left ventricular mass index|beta coefficient|0.23|STANDARD_ERROR_OF_MEAN|0.09||0.01|TWO_SIDED|95.0|0.05|0.4|||Regression, Linear|||We determined the association between asleep diastolic blood pressure on home blood pressure monitoring (HBPM) and left ventricular mass index (LVMI). This analysis included 533 participants with data on HBPM and valid LVMI. This analysis combined across study arms as prespecified in the Study Protocol and Statistical Analysis Plan.||0.40|0.05|0.01
72415674|NCT04307004|144342061|OTHER|Independent variable - asleep systolic blood pressure on ABPM. Dependent variable - left ventricular mass index.|beta coefficient|0.45|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|95.0|0.32|0.59|||Regression, Linear|||We determined the association between asleep systolic blood pressure on ambulatory blood pressure monitoring (ABPM) and left ventricular mass index (LVMI). This analysis included 533 participants with data on ABPM and valid LVMI. This analysis combined across study arms as prespecified in the Study Protocol and Statistical Analysis Plan.||0.59|0.32|< 0.001
72415675|NCT04307004|144342061|OTHER|Independent variable - asleep diastolic blood pressure on ABPM Dependent variable - left ventricular mass index.|beta coefficient|0.36|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|0.16|0.55|||Regression, Linear|||We determined the association between asleep diastolic blood pressure on ambulatory blood pressure monitoring (ABPM) and left ventricular mass index (LVMI). This analysis included 533 participants with data on ABPM and valid LVMI. This analysis combined across study arms as prespecified in the Study Protocol and Statistical Analysis Plan.||0.55|0.16|< 0.001
72596892|NCT01066793|144724949|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.723||||0.0306|TWO_SIDED|95.0|0.538|0.97|||Regression, Logistic|||The statistical analysis is presented for cumulative ribavirin dose per 10000 mg, first 12 weeks. The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.970|0.538|0.0306
72596893|NCT01066793|144724949|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.145||||0.0005|TWO_SIDED|95.0|1.061|1.236|||Regression, Logistic|||The statistical analysis is presented for BMI in kg/m\^2. The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.236|1.061|0.0005
72596894|NCT01066793|144724949|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.907||||0.0122|TWO_SIDED|95.0|1.151|3.158|||Regression, Logistic|||The statistical analysis is presented for HCV RNA at BL in log10 (IU/mL). The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||3.158|1.151|0.0122
72596895|NCT01066793|144724949|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.175||||0.0956|TWO_SIDED|95.0|0.872|5.424|||Regression, Logistic|||The statistical analysis is presented for Platelets x 10\*\*9/L at BL (\< 140 vs \>=180). The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||5.424|0.872|0.0956
72415676|NCT04307004|144342062|OTHER|Independent variable - attended systolic blood pressure. Dependent variable - urinary albumin-to-creatinine ratio.|beta coefficient|-0.2|STANDARD_ERROR_OF_MEAN|0.14||0.17|TWO_SIDED|95.0|-0.47|0.08|||Regression, Linear|||We determined the association between attended systolic blood pressure and urinary albumin-to-creatinine ratio (UACR). This analysis included 555 participants with complete data on attended office blood pressure and UACR. This analysis combined across study arms as prespecified in the Study Protocol and Statistical Analysis Plan.||0.08|-0.47|0.17
72415677|NCT04307004|144342062|OTHER|Independent variable - attended diastolic blood pressure. Dependent variable - urinary albumin-to-creatinine ratio.|beta coefficient|-0.28|STANDARD_ERROR_OF_MEAN|0.22||0.2|TWO_SIDED|95.0|-0.7|0.15|||Regression, Linear|||We determined the association between attended diastolic blood pressure and urinary albumin-to-creatinine ratio (UACR). This analysis included 555 participants with complete data on attended office blood pressure and UACR. This analysis combined across study arms as prespecified in the Study Protocol and Statistical Analysis Plan.||0.15|-0.70|0.20
72596896|NCT01066793|144724949|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.267||||0.0846|TWO_SIDED|95.0|0.06|1.197|||Regression, Logistic|||The statistical analysis is presented for Platelets x 10\*\*9/L at BL (\>=140 - \< 180 vs \>=180). The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.197|0.060|0.0846
72596897|NCT01066793|144724949|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.897|||<|0.0001|TWO_SIDED|95.0|0.852|0.945|||Regression, Logistic|||The statistical analysis is presented for treatment duration after VR in weeks. The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.945|0.852|<0.0001
72596898|NCT01066793|144724949|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.996||||0.0033|TWO_SIDED|95.0|1.259|3.165|||Regression, Logistic|||The statistical analysis is presented for age per 10 years. The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||3.165|1.259|0.0033
72596899|NCT01066793|144724949|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.15||||0.0095|TWO_SIDED|95.0|1.035|1.277|||Regression, Logistic|||The statistical analysis is presented for BMI in kg/m\^2. The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.277|1.035|0.0095
72596900|NCT01066793|144724949|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.155||||0.0031|TWO_SIDED|95.0|0.045|0.533|||Regression, Logistic|||The statistical analysis is presented for liver fibrosis (no cirrhosis vs cirrhosis). The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.533|0.045|0.0031
72596901|NCT01066793|144724949|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.364||||0.0645|TWO_SIDED|95.0|0.125|1.063|||Regression, Logistic|||The statistical analysis is presented for liver fibrosis (not assessed/missing vs cirrhosis). The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.063|0.125|0.0645
72596902|NCT01066793|144724949|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.895||||0.0001|TWO_SIDED|95.0|0.846|0.948|||Regression, Logistic|||The statistical analysis is presented for treatment duration after VR in weeks. The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.948|0.846|0.0001
72596903|NCT01066793|144724949|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.996||||0.0033|TWO_SIDED|95.0|1.259|3.165|||Regression, Logistic|||The statistical analysis is presented for age per 10 years. The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||3.165|1.259|0.0033
72596904|NCT01066793|144724949|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.15||||0.0095|TWO_SIDED|95.0|1.035|1.277|||Regression, Logistic|||The statistical analysis is presented for BMI in kg/m\^2. The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.277|1.035|0.0095
72596905|NCT01066793|144724949|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.155||||0.0031|TWO_SIDED|95.0|0.045|0.533|||Regression, Logistic|||The statistical analysis is presented for liver fibrosis (no cirrhosis vs cirrhosis). The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.533|0.045|0.0031
72596906|NCT01066793|144724949|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.364||||0.0645|TWO_SIDED|95.0|0.125|1.063|||Regression, Logistic|||The statistical analysis is presented for liver fibrosis (not assessed/missing vs cirrhosis). The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.063|0.125|0.0645
72596907|NCT01066793|144724949|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.895||||0.0001|TWO_SIDED|95.0|0.846|0.948|||Regression, Logistic|||The statistical analysis is presented for treatment duration after VR in weeks. The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.948|0.846|0.0001
72596908|NCT01066793|144724949|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.266||||0.0182|TWO_SIDED|95.0|1.041|1.541|||Regression, Logistic|||The statistical analysis is presented for age per 10 years. The logistic regression analysis for relapse was performed for association between treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.541|1.041|0.0182
72596909|NCT01066793|144724949|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.59||||0.0092|TWO_SIDED|95.0|1.122|2.254|||Regression, Logistic|||The statistical analysis is presented for HCV RNA at BL in log10 (IU/mL). The logistic regression analysis for relapse was performed for association between treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||2.254|1.122|0.0092
72596910|NCT01066793|144724949|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.974||||0.002|TWO_SIDED|95.0|1.488|5.942|||Regression, Logistic|||The statistical analysis is presented for Platelets x 10\*\*9/L at BL (\< 140 vs \>=180). The logistic regression analysis for relapse was performed for association between treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||5.942|1.488|0.0020
72596911|NCT01066793|144724949|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.142||||0.6524|TWO_SIDED|95.0|0.641|2.035|||Regression, Logistic|||The statistical analysis is presented for Platelets x 10\*\*9/L at BL (\>=140 - \< 180 vs \>=180). The logistic regression analysis for relapse was performed for association between treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||2.035|0.641|0.6524
72596912|NCT01066793|144724949|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.108|||<|0.0001|TWO_SIDED|95.0|0.037|0.311|||Regression, Logistic|||The statistical analysis is presented for on-treatment response (RVR vs No RVR/EVR). The logistic regression analysis for relapse was performed for association between treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.311|0.037|<0.0001
72596913|NCT01066793|144724949|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.389||||0.0429|TWO_SIDED|95.0|0.156|0.97|||Regression, Logistic|||The statistical analysis is presented for on-treatment response (cEVR vs No RVR/EVR). The logistic regression analysis for relapse was performed for association between treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.970|0.156|0.0429
72596914|NCT01066793|144724949|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.33||||0.549|TWO_SIDED|95.0|0.523|3.38|||Regression, Logistic|||The statistical analysis is presented for on-treatment response (pEVR vs No RVR/EVR). The logistic regression analysis for relapse was performed for association between treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||3.380|0.523|0.5490
72596915|NCT01066793|144724949|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.136||||0.0008|TWO_SIDED|95.0|1.054|1.224|||Regression, Logistic|||The statistical analysis is presented for BMI in kg/m\^2. The logistic regression analysis for relapse was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.224|1.054|0.0008
72596916|NCT01066793|144724949|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.855||||0.014|TWO_SIDED|95.0|1.133|3.037|||Regression, Logistic|||The statistical analysis is presented for HCV RNA at BL in log10 (IU/mL). The logistic regression analysis for relapse was performed for association between treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||3.037|1.133|0.0140
72415678|NCT04307004|144342062|OTHER|Independent variable - unattended systolic blood pressure. Dependent variable - urinary albumin-to-creatinine ratio.|beta coefficient|-0.26|STANDARD_ERROR_OF_MEAN|0.14||0.07|TWO_SIDED|95.0|-0.55|0.02|||Regression, Linear|||We determined the association between unattended systolic blood pressure and urinary albumin-to-creatinine ratio (UACR). This analysis included 555 participants with complete data on unattended blood pressure and UACR. This analysis combined across study arms as prespecified in the Study Protocol and Statistical Analysis Plan.||0.02|-0.55|0.07
72596917|NCT01066793|144724949|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.126||||0.0575|TWO_SIDED|95.0|0.015|1.068|||Regression, Logistic|||The statistical analysis is presented for on-treatment response (RVR vs No RVR/EVR). The logistic regression analysis for relapse was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.068|0.015|0.0575
72596918|NCT01066793|144724949|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.66||||0.7128|TWO_SIDED|95.0|0.072|6.025|||Regression, Logistic|||The statistical analysis is presented for on-treatment response (cEVR vs No RVR/EVR). The logistic regression analysis for relapse was performed for association between treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||6.025|0.072|0.7128
72596919|NCT01066793|144724949|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.505||||0.596|TWO_SIDED|95.0|0.04|6.318|||Regression, Logistic|||The statistical analysis is presented for on-treatment response (pEVR vs No RVR/EVR). The logistic regression analysis for relapse was performed for association between treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||6.318|0.040|0.5960
72596920|NCT01066793|144724949|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.051||||0.0033|TWO_SIDED|95.0|1.27|3.311|||Regression, Logistic|||The statistical analysis is presented for age per 10 years. The logistic regression analysis for relapse was performed for association between treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||3.311|1.270|0.0033
72596921|NCT01066793|144724949|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.113||||0.0452|TWO_SIDED|95.0|1.002|1.236|||Regression, Logistic|||The statistical analysis is presented for BMI in kg/m\^2. The logistic regression analysis for relapse was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.236|1.002|0.0452
72596922|NCT01066793|144724949|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.154||||0.004|TWO_SIDED|95.0|0.043|0.551|||Regression, Logistic|||The statistical analysis is presented for liver fibrosis (no cirrhosis vs cirrhosis). The logistic regression analysis for relapse was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.551|0.043|0.0040
72596923|NCT01066793|144724949|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.393||||0.0833|TWO_SIDED|95.0|0.137|1.131|||Regression, Logistic|||The statistical analysis is presented for liver fibrosis (not assessed/missing vs cirrhosis). The logistic regression analysis for relapse was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a||1.131|0.137|0.0833
72596924|NCT01066793|144724949|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.141||||0.1439|TWO_SIDED|95.0|0.01|1.951|||Regression, Logistic|||The statistical analysis is presented for on-treatment response (RVR vs No RVR/EVR). The logistic regression analysis for relapse was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.951|0.010|0.1439
72596925|NCT01066793|144724949|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.35||||0.4457|TWO_SIDED|95.0|0.024|5.194|||Regression, Logistic|||The statistical analysis is presented for on-treatment response (cEVR vs No RVR/EVR). The logistic regression analysis for relapse was performed for association between treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||5.194|0.024|0.4457
72596926|NCT01066793|144724949|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.142||||0.6258|TWO_SIDED|95.0|0.1|45.801|||Regression, Logistic|||The statistical analysis is presented for on-treatment response (pEVR vs No RVR/EVR). The logistic regression analysis for relapse was performed for association between treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||45.801|0.100|0.6258
72596927|NCT03334422|144724964|SUPERIORITY||Odds Ratio (OR)|2.58||||0.026|TWO_SIDED|95.0|1.12|5.92|||Regression, Logistic|||||5.92|1.12|0.026
72596928|NCT03334422|144724964|SUPERIORITY||Odds Ratio (OR)|3.64||||0.001|TWO_SIDED|95.0|1.64|8.05|||Regression, Logistic|||||8.05|1.64|0.001
72596929|NCT03334422|144724965|SUPERIORITY||Odds Ratio (OR)|2.13||||0.085|TWO_SIDED|95.0|0.9|5.02|||Regression, Logistic|||||5.02|0.90|0.085
72415679|NCT04307004|144342062|OTHER|Independent variable - unattended diastolic blood pressure. Dependent variable - urinary albumin-to-creatinine ratio.|beta coefficient|-0.37|STANDARD_ERROR_OF_MEAN|0.22||0.09|TWO_SIDED|95.0|-0.8|0.06|||Regression, Linear|||We determined the association between unattended diastolic blood pressure and urinary albumin-to-creatinine ratio (UACR). This analysis included 555 participants with complete data on unattended diastolic blood pressure and UACR. This analysis combined across study arms as prespecified in the Study Protocol and Statistical Analysis Plan.||0.06|-0.80|0.09
72415680|NCT04307004|144342062|OTHER|"Independent variable - awake systolic blood pressure on ambulatory blood pressure monitoring.~Dependent variable - urinary albumin-to-creatinine ratio."|beta coefficient|0.01|STANDARD_ERROR_OF_MEAN|0.15||0.94|TWO_SIDED|95.0|-0.29|0.31|||Regression, Linear|||We determined the association between awake systolic blood pressure on ambulatory blood pressure monitoring (ABPM) and urinary albumin-to-creatinine ratio (UACR). This analysis included 523 participants with complete data on ABPM and UACR. This analysis combined across study arms as prespecified in the Study Protocol and Statistical Analysis Plan.||0.31|-0.29|0.94
72415681|NCT04307004|144342062|OTHER|"Independent variable - awake diastolic blood pressure on ambulatory blood pressure monitoring.~Dependent variable - urinary albumin-to-creatinine ratio."|beta coefficient|0.22|STANDARD_ERROR_OF_MEAN|0.22||0.31|TWO_SIDED|95.0|-0.21|0.66|||Regression, Linear|||We determined the association between awake diastolic blood pressure on ambulatory blood pressure monitoring (ABPM) and urinary albumin-to-creatinine ratio (UACR). This analysis included 523 participants with complete data on ABPM and UACR. This analysis combined across study arms as prespecified in the Study Protocol and Statistical Analysis Plan.||0.66|-0.21|0.31
72415682|NCT04307004|144342062|OTHER|Independent variable - asleep systolic blood pressure on HBPM. Dependent variable - urinary albumin-to-creatinine ratio.|beta coefficient|-0.01|STANDARD_ERROR_OF_MEAN|0.14||0.94|TWO_SIDED|95.0|-0.28|0.26|||Regression, Linear|||We determined the association between asleep systolic blood pressure on home blood pressure monitoring (HBPM) and urinary albumin-to-creatinine ratio (UACR). This analysis included 505 participants with complete HBPM and UACR data. This analysis combined across study arms as prespecified in the Study Protocol and Statistical Analysis Plan.||0.26|-0.28|0.94
72596930|NCT03334422|144724966|SUPERIORITY||Odds Ratio (OR)|2.35||||0.024|TWO_SIDED|95.0|1.12|4.93|||Regression, Logistic|||||4.93|1.12|0.024
72596931|NCT03334422|144724966|SUPERIORITY||Odds Ratio (OR)|3.49|||<|0.001|TWO_SIDED|95.0|1.73|7.04|||Regression, Logistic|||||7.04|1.73|<0.001
72596932|NCT03334422|144724966|SUPERIORITY||Odds Ratio (OR)|4.41|||<|0.001|TWO_SIDED|95.0|2.22|8.76|||Regression, Logistic|||||8.76|2.22|<0.001
72596933|NCT03334422|144724967|SUPERIORITY||Odds Ratio (OR)|2.8||||0.053|TWO_SIDED|95.0|0.99|7.97|||Regression, Logistic|||||7.97|0.99|0.053
72596934|NCT03334422|144724967|SUPERIORITY||Odds Ratio (OR)|3.87||||0.007|TWO_SIDED|95.0|1.44|10.41|||Regression, Logistic|||||10.41|1.44|0.007
72596935|NCT03334422|144724967|SUPERIORITY||Odds Ratio (OR)|6.2|||<|0.001|TWO_SIDED|95.0|2.42|15.91|||Regression, Logistic|||||15.91|2.42|<0.001
72596936|NCT03334422|144724968|SUPERIORITY||Mean Difference (Net)|-12.76|STANDARD_ERROR_OF_MEAN|6.81||0.062|TWO_SIDED|95.0|-26.19|0.66|||Mixed Models Analysis|||||0.66|-26.19|0.062
72596937|NCT03334422|144724968|SUPERIORITY||Mean Difference (Net)|-25.89|STANDARD_ERROR_OF_MEAN|6.54|<|0.001|TWO_SIDED|95.0|-38.78|-12.99|||Mixed Models Analysis|||||-12.99|-38.78|<0.001
72596938|NCT03334422|144724968|SUPERIORITY||Mean Difference (Net)|-25.97|STANDARD_ERROR_OF_MEAN|6.24|<|0.001|TWO_SIDED|95.0|-38.29|-13.65|||Mixed Models Analysis|||||-13.65|-38.29|<0.001
72596939|NCT03334422|144724969|SUPERIORITY||Odds Ratio (OR)|2.9||||0.086|TWO_SIDED|95.0|0.86|9.76|||Regression, Logistic|||||9.76|0.86|0.086
72596940|NCT03334422|144724969|SUPERIORITY||Odds Ratio (OR)|4.95||||0.006|TWO_SIDED|95.0|1.58|15.49|||Regression, Logistic|||||15.49|1.58|0.006
72596941|NCT03334422|144724969|SUPERIORITY||Odds Ratio (OR)|7.4|||<|0.001|TWO_SIDED|95.0|2.51|21.83|||Regression, Logistic|||||21.83|2.51|<0.001
72596942|NCT03334422|144724970|SUPERIORITY||Odds Ratio (OR)|1.41||||0.505|TWO_SIDED|95.0|0.51|3.87|||Regression, Logistic|||||3.87|0.51|0.505
72596943|NCT03334422|144724970|SUPERIORITY||Odds Ratio (OR)|3.64||||0.002|TWO_SIDED|95.0|1.6|8.27|||Regression, Logistic|||||8.27|1.60|0.002
72596944|NCT03334422|144724970|SUPERIORITY||Odds Ratio (OR)|4.91|||<|0.001|TWO_SIDED|95.0|2.22|10.86|||Regression, Logistic|||||10.86|2.22|<0.001
72596945|NCT03334422|144724971|SUPERIORITY||Mean Difference (Net)|-0.27|STANDARD_ERROR_OF_MEAN|0.15||0.074|TWO_SIDED|95.0|-0.57|0.03|||Mixed Models Analysis|||||0.03|-0.57|0.074
72596946|NCT03334422|144724971|SUPERIORITY||Mean Difference (Net)|-0.38|STANDARD_ERROR_OF_MEAN|0.15||0.011|TWO_SIDED|95.0|-0.68|-0.09|||Mixed Models Analysis|||||-0.09|-0.68|0.011
72596947|NCT03334422|144724971|SUPERIORITY||Mean Difference (Net)|-0.55|STANDARD_ERROR_OF_MEAN|0.15|<|0.001|TWO_SIDED|95.0|-0.84|-0.26|||Mixed Models Analysis|||||-0.26|-0.84|<0.001
72596948|NCT03334422|144724972|SUPERIORITY||Mean Difference (Net)|-0.23|STANDARD_ERROR_OF_MEAN|0.41||0.58|TWO_SIDED|95.0|-1.05|0.59|||Mixed Models Analysis|||||0.59|-1.05|0.580
72596949|NCT03334422|144724972|SUPERIORITY||Mean Difference (Net)|-1.75|STANDARD_ERROR_OF_MEAN|0.4|<|0.001|TWO_SIDED|95.0|-2.54|-0.96|||Mixed Models Analysis|||||-0.96|-2.54|<0.001
72596950|NCT03334422|144724972|SUPERIORITY||Mean Difference (Net)|-1.62|STANDARD_ERROR_OF_MEAN|0.38|<|0.001|TWO_SIDED|95.0|-2.37|-0.87|||Mixed Models Analysis|||||-0.87|-2.37|<0.001
72596951|NCT03334422|144724973|SUPERIORITY||Odds Ratio (OR)|1.67||||0.094|TWO_SIDED|95.0|0.92|3.04|||Regression, Logistic|||||3.04|0.92|0.094
72596952|NCT03334422|144724973|SUPERIORITY||Odds Ratio (OR)|2.91|||<|0.001|TWO_SIDED|95.0|1.65|5.11|||Regression, Logistic|||||5.11|1.65|<0.001
72596953|NCT03334422|144724973|SUPERIORITY||Odds Ratio (OR)|3.15|||<|0.001|TWO_SIDED|95.0|1.8|5.51|||Regression, Logistic|||||5.51|1.80|<0.001
72596954|NCT03334422|144724974|SUPERIORITY||Odds Ratio (OR)|1.57||||0.528|TWO_SIDED|95.0|0.39|6.31|||Regression, Logistic|||||6.31|0.39|0.528
72596955|NCT03334422|144724974|SUPERIORITY||Odds Ratio (OR)|2.56||||0.142|TWO_SIDED|95.0|0.73|8.95|||Regression, Logistic|||||8.95|0.73|0.142
72596956|NCT03334422|144724974|SUPERIORITY||Odds Ratio (OR)|2.68||||0.123|TWO_SIDED|95.0|0.77|9.37|||Regression, Logistic|||||9.37|0.77|0.123
72552499|NCT01811953|144635828|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMean), test/reference, for the primary endpoints using an acceptance range of 80.00 to 125.00%.|Geometric mean ratio|102.33|STANDARD_ERROR_OF_MEAN|1.017|<|0.0001|TWO_SIDED|90.0|99.315|105.43|||ANOVA||The geometric mean ratio was calculated as the geometric mean of '1 Empagliflozin/Metformin (T)' divided by the geometric mean of '3 Empagliflozin + Metformin (R)'.|||105.430|99.315|<0.0001
72552500|NCT01811953|144635828|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMean), test/reference, for the primary endpoints using an acceptance range of 80.00 to 125.00%.|Geometric mean ratio|98.82|STANDARD_ERROR_OF_MEAN|1.024|<|0.0001|TWO_SIDED|90.0|94.784|103.037|||ANOVA||The geometric mean ratio was calculated as the geometric mean of '2 Empagliflozin/Metformin (T)' divided by the geometric mean of '4 Empagliflozin + Metformin (R)'.|||103.037|94.784|<0.0001
72552501|NCT01811953|144635828|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMean), test/reference, for the primary endpoints using an acceptance range of 80.00 to 125.00%.|Geometric mean ratio|105.98|STANDARD_ERROR_OF_MEAN|1.018|<|0.0001|TWO_SIDED|90.0|102.73|109.329|||ANOVA||The geometric mean ratio was calculated as the geometric mean of '5 Empagliflozin/Metformin (T)' divided by the geometric mean of '6 Empagliflozin + Metformin (R)'.|||109.329|102.730|<0.0001
72552502|NCT01811953|144635829|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMean), test/reference, for the primary endpoints using an acceptance range of 80.00 to 125.00%.|Geometric mean ratio|102.12|STANDARD_ERROR_OF_MEAN|1.035|<|0.0001|TWO_SIDED|90.0|96.255|108.351|||ANOVA||The geometric mean ratio was calculated as the geometric mean of '1 Empagliflozin/Metformin (T)' divided by the geometric mean of '3 Empagliflozin + Metformin (R)'.|||108.351|96.255|<0.0001
72552503|NCT01811953|144635829|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMean), test/reference, for the primary endpoints using an acceptance range of 80.00 to 125.00%.|Geometric mean ratio|106.52|STANDARD_ERROR_OF_MEAN|1.063||0.0082|TWO_SIDED|90.0|95.863|118.353|||ANOVA||The geometric mean ratio was calculated as the geometric mean of '2 Empagliflozin/Metformin (T)' divided by the geometric mean of '4 Empagliflozin + Metformin (R)'.|||118.353|95.863|0.0082
72596957|NCT03334422|144724975|SUPERIORITY||LSMean Difference|-6.88|STANDARD_ERROR_OF_MEAN|3.63||0.059|TWO_SIDED|95.0|-14.03|0.28|||Mixed Models Analysis|||||0.28|-14.03|0.059
72552504|NCT01811953|144635829|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMean), test/reference, for the primary endpoints using an acceptance range of 80.00 to 125.00%.|Geometric mean ratio|104.352|STANDARD_ERROR_OF_MEAN|1.031|<|0.0001|TWO_SIDED|90.0|99.152|110.224|||ANOVA||The geometric mean ratio was calculated as the geometric mean of '5 Empagliflozin/Metformin (T)' divided by the geometric mean of '6 Empagliflozin + Metformin (R)'.|||110.224|99.152|<0.0001
72552505|NCT01811953|144635830|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMean), test/reference, for the primary endpoints using an acceptance range of 80.00 to 125.00%.|Geometric mean ratio|94.87|STANDARD_ERROR_OF_MEAN|1.038||0.0001|TWO_SIDED|90.0|88.931|101.21|||ANOVA||The geometric mean ratio was calculated as the geometric mean of '1 Empagliflozin/Metformin (T)' divided by the geometric mean of '3 Empagliflozin + Metformin (R)'.|||101.210|88.931|0.0001
72596958|NCT03334422|144724975|SUPERIORITY||LSMean Difference|-14.48|STANDARD_ERROR_OF_MEAN|3.47|<|0.001|TWO_SIDED|95.0|-21.32|-7.63|||Mixed Models Analysis|||||-7.63|-21.32|<0.001
72596959|NCT03334422|144724975|SUPERIORITY||LSMean Difference|-14.15|STANDARD_ERROR_OF_MEAN|3.32|<|0.001|TWO_SIDED|95.0|-20.69|-7.61|||Mixed Models Analysis|||||-7.61|-20.69|<0.001
72596960|NCT03334422|144724976|SUPERIORITY||Odds Ratio (OR)|2.55||||0.193|TWO_SIDED|95.0|0.62|10.45|||Regression, Logistic|||||10.45|0.62|0.193
72596961|NCT03334422|144724976|SUPERIORITY||Odds Ratio (OR)|4.1||||0.042|TWO_SIDED|95.0|1.05|16.03|||Mixed Models Analysis|||||16.03|1.05|0.042
72596962|NCT03334422|144724976|SUPERIORITY||Odds Ratio (OR)|3.89||||0.044|TWO_SIDED|95.0|1.04|14.57|||Regression, Logistic|||||14.57|1.04|0.044
72596963|NCT03334422|144724977|SUPERIORITY||LSMean Difference|-6.16|STANDARD_ERROR_OF_MEAN|3.23||0.058|TWO_SIDED|95.0|-12.53|0.21|||Mixed Models Analysis|||||0.21|-12.53|0.058
72596964|NCT03334422|144724977|SUPERIORITY||LSMean Difference|-9.3|STANDARD_ERROR_OF_MEAN|3.1||0.003|TWO_SIDED|95.0|-15.42|-3.18|||Mixed Models Analysis|||||-3.18|-15.42|0.003
72596965|NCT03334422|144724977|SUPERIORITY||LSMean Difference|-11.16|STANDARD_ERROR_OF_MEAN|2.98|<|0.001|TWO_SIDED|95.0|-17.03|-5.3|||Mixed Models Analysis|||||-5.30|-17.03|<0.001
72596966|NCT03334422|144724978|SUPERIORITY|||||||0.189|||||||Fisher Exact|||||||0.189
72596967|NCT03334422|144724978|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1
72596968|NCT03334422|144724978|SUPERIORITY|||||||0.383|||||||Fisher Exact|||||||0.383
72596969|NCT03334422|144724979|SUPERIORITY||LSMean Difference|-14.8|STANDARD_ERROR_OF_MEAN|8.46||0.081|TWO_SIDED|95.0|-31.45|1.85|||Mixed Models Analysis|||||1.85|-31.45|0.081
72596970|NCT03334422|144724979|SUPERIORITY||LSMean Difference|-30.66|STANDARD_ERROR_OF_MEAN|8.11|<|0.001|TWO_SIDED|95.0|-46.62|-14.7|||Mixed Models Analysis|||||-14.70|-46.62|<0.001
72596971|NCT03334422|144724979|SUPERIORITY||LSMean Difference|-30.28|STANDARD_ERROR_OF_MEAN|7.63|<|0.001|TWO_SIDED|95.0|-45.29|-15.27|||Mixed Models Analysis|||||-15.27|-45.29|<0.001
72596972|NCT03334422|144724980|SUPERIORITY||LSMean Difference|-2.36|STANDARD_ERROR_OF_MEAN|1.32||0.075|TWO_SIDED|95.0|-4.97|0.24|||Mixed Models Analysis|||||0.24|-4.97|0.075
72596973|NCT03334422|144724980|SUPERIORITY||LSMean Difference|-5.58|STANDARD_ERROR_OF_MEAN|1.27|<|0.001|TWO_SIDED|95.0|-8.07|-3.08|||Mixed Models Analysis|||||-3.08|-8.07|<0.001
72596974|NCT03334422|144724980|SUPERIORITY||LSMean Difference|-6.07|STANDARD_ERROR_OF_MEAN|1.21|<|0.001|TWO_SIDED|95.0|-8.47|-3.68|||Mixed Models Analysis|||||-3.68|-8.47|<0.001
72596975|NCT03334422|144724981|SUPERIORITY||LSMean Difference|-0.27|STANDARD_ERROR_OF_MEAN|0.17||0.13|TWO_SIDED|95.0|-0.61|0.08|||Mixed Models Analysis|||||0.08|-0.61|0.130
72596976|NCT03334422|144724981|SUPERIORITY||LSMean Difference|-0.61|STANDARD_ERROR_OF_MEAN|0.17|<|0.001|TWO_SIDED|95.0|-0.94|-0.28|||Mixed Models Analysis|||||-0.28|-0.94|<0.001
72596977|NCT03334422|144724981|SUPERIORITY||LSMean Difference|-0.69|STANDARD_ERROR_OF_MEAN|0.16|<|0.001|TWO_SIDED|95.0|-1.0|-0.38|||Mixed Models Analysis|||||-0.38|-1.00|<0.001
72596978|NCT03334422|144724982|SUPERIORITY||LSMean Difference|-0.94|STANDARD_ERROR_OF_MEAN|0.51||0.067|TWO_SIDED|95.0|-1.95|0.07|||Mixed Models Analysis|||HADS Anxiety.||0.07|-1.95|0.067
72596979|NCT03334422|144724982|SUPERIORITY||LSMean Difference|-0.93|STANDARD_ERROR_OF_MEAN|0.49||0.06|TWO_SIDED|95.0|-1.89|0.04|||Mixed Models Analysis|||HADS Anxiety.||0.04|-1.89|0.060
72596980|NCT03334422|144724982|SUPERIORITY||LSMean Difference|-1.3|STANDARD_ERROR_OF_MEAN|0.47||0.006|TWO_SIDED|95.0|-2.23|-0.38|||Mixed Models Analysis|||HADS Anxiety.||-0.38|-2.23|0.006
72596981|NCT03334422|144724982|SUPERIORITY||LSMean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.51||0.321|TWO_SIDED|95.0|-1.5|0.49|||Mixed Models Analysis|||HADS Depression.||0.49|-1.50|0.321
72596982|NCT03334422|144724982|SUPERIORITY||LSMean Difference|-0.71|STANDARD_ERROR_OF_MEAN|0.49||0.143|TWO_SIDED|95.0|-1.67|0.24|||Mixed Models Analysis|||HADS Depression.||0.24|-1.67|0.143
72596983|NCT03334422|144724982|SUPERIORITY||LSMean Difference|-1.18|STANDARD_ERROR_OF_MEAN|0.47||0.012|TWO_SIDED|95.0|-2.11|-0.26|||Mixed Models Analysis|||HADS Depression.||-0.26|-2.11|0.012
72596984|NCT03334422|144724983|SUPERIORITY||LSMean Difference|-1.76|STANDARD_ERROR_OF_MEAN|0.97||0.071|TWO_SIDED|95.0|-3.67|0.15|||Mixed Models Analysis|||||0.15|-3.67|0.071
72596985|NCT03334422|144724983|SUPERIORITY||LSMean Difference|-4.09|STANDARD_ERROR_OF_MEAN|0.93|<|0.001|TWO_SIDED|95.0|-5.92|-2.26|||Mixed Models Analysis|||||-2.26|-5.92|<0.001
72596986|NCT03334422|144724983|SUPERIORITY||LSMean Difference|-4.22|STANDARD_ERROR_OF_MEAN|0.9|<|0.001|TWO_SIDED|95.0|-5.98|-2.45|||Mixed Models Analysis|||||-2.45|-5.98|<0.001
72596987|NCT03334422|144724984|SUPERIORITY||LSMean Difference|-0.91|STANDARD_ERROR_OF_MEAN|5.17||0.861|TWO_SIDED|95.0|-11.16|9.34|||Mixed Models Analysis|||Percentage of Absenteeism Change from Baseline||9.34|-11.16|0.861
72596988|NCT03334422|144724984|SUPERIORITY||LSMean Difference|1.01|STANDARD_ERROR_OF_MEAN|5.03||0.841|TWO_SIDED|95.0|-8.94|10.97||Absenteeism|Mixed Models Analysis|||Percentage of Absenteeism Change from Baseline||10.97|-8.94|0.841
72596989|NCT03334422|144724984|SUPERIORITY||LSMean Difference|5.16|STANDARD_ERROR_OF_MEAN|4.6||0.264|TWO_SIDED|95.0|-3.95|14.26|||Mixed Models Analysis|||Percentage of Absenteeism Change from Baseline||14.26|-3.95|0.264
72596990|NCT03334422|144724984|SUPERIORITY||LSMean Difference|-3.12|STANDARD_ERROR_OF_MEAN|5.63||0.58|TWO_SIDED|95.0|-14.26|8.02|||Mixed Models Analysis|||Percentage of Presenteeism (Reduced Productivity While at Work) Change from Baseline||8.02|-14.26|0.580
72596991|NCT03334422|144724984|SUPERIORITY||LSMean Difference|-13.56|STANDARD_ERROR_OF_MEAN|5.5||0.015|TWO_SIDED|95.0|-24.45|-2.86|||Mixed Models Analysis|||Percentage of Presenteeism (Reduced Productivity While at Work) Change from Baseline||-2.86|-24.45|0.015
72596992|NCT03334422|144724984|SUPERIORITY||LSMean Difference|-13.13|STANDARD_ERROR_OF_MEAN|5.08||0.011|TWO_SIDED|95.0|-23.2|-3.06|||Mixed Models Analysis|||Percentage of Presenteeism (Reduced Productivity While at Work) Change from Baseline||-3.06|-23.20|0.011
72596993|NCT03334422|144724984|SUPERIORITY||LSMean Difference|-1.81|STANDARD_ERROR_OF_MEAN|6.71||0.788|TWO_SIDED|95.0|-15.12|11.49|||Mixed Models Analysis|||Work Productivity Loss (Percentage Overall Work Impairment/Absenteeism Plus Presenteeism) Change from Baseline||11.49|-15.12|0.788
72552506|NCT01811953|144635830|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMean), test/reference, for the primary endpoints using an acceptance range of 80.00 to 125.00%.|Geometric mean ratio|97.97|STANDARD_ERROR_OF_MEAN|1.035|<|0.0001|TWO_SIDED|90.0|92.339|103.935|||ANOVA||The geometric mean ratio was calculated as the geometric mean of '2 Empagliflozin/Metformin (T)' divided by the geometric mean of '4 Empagliflozin + Metformin (R)'.|||103.935|92.339|<0.0001
72552507|NCT01811953|144635830|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMean), test/reference, for the primary endpoints using an acceptance range of 80.00 to 125.00%.|Geometric mean ratio|102.95|STANDARD_ERROR_OF_MEAN|1.034|<|0.0001|TWO_SIDED|90.0|97.166|109.082|||ANOVA||The geometric mean ratio was calculated as the geometric mean of '5 Empagliflozin/Metformin (T)' divided by the geometric mean of '6 Empagliflozin + Metformin (R)'.|||109.082|97.166|<0.0001
72596994|NCT03334422|144724984|SUPERIORITY||LSMean Difference|-9.48|STANDARD_ERROR_OF_MEAN|6.57||0.152|TWO_SIDED|95.0|-22.51|3.55|||Mixed Models Analysis|||Work Productivity Loss (Percentage Overall Work Impairment/Absenteeism Plus Presenteeism) Change from Baseline||3.55|-22.51|0.152
72552508|NCT01811953|144635831|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMean), test/reference, for the primary endpoints using an acceptance range of 80.00 to 125.00%.|Geometric mean ratio|94.89|STANDARD_ERROR_OF_MEAN|1.03|<|0.0001|TWO_SIDED|90.0|89.8|100.26|||ANOVA||The geometric mean ratio was calculated as the geometric mean of '1 Empagliflozin/Metformin (T)' divided by the geometric mean of '3 Empagliflozin + Metformin (R)'.|||100.26|89.80|<0.0001
72415683|NCT04307004|144342062|OTHER|Independent variable - asleep diastolic blood pressure on HBPM. Dependent variable - urinary albumin-to-creatinine ratio.|beta coefficient|-0.02|STANDARD_ERROR_OF_MEAN|0.2||0.93|TWO_SIDED|95.0|-0.4|0.36|||Regression, Linear|||We determined the association between asleep diastolic blood pressure on home blood pressure monitoring (HBPM) and urinary albumin-to-creatinine ratio (UACR). This analysis included 505 participants with complete HBPM and UACR data. This analysis combined across study arms as prespecified in the Study Protocol and Statistical Analysis Plan.||0.36|-0.40|0.93
72421599|NCT03720938|144354380|SUPERIORITY|||||||0.259||||||The outcomes of fat ratio was tested for any difference between groups by covariate analysis (ANCOVA) adjusted for the fat ratio at baseline and confounding variable age.|ANCOVA|Adjusted for cluster effect in addition to baseline value and age.||Null hypothesis was the absence of difference between the two groups for the dependent variable fat ratio.||||0.259
72415684|NCT04307004|144342062|OTHER|Independent variable - asleep systolic blood pressure on ABPM. Dependent variable - urinary albumin-to-creatinine ratio.|beta coefficient|0.09|STANDARD_ERROR_OF_MEAN|0.15||0.54|TWO_SIDED|95.0|-0.21|0.4|||Regression, Linear|||We determined the association between asleep systolic blood pressure on ambulatory blood pressure monitoring (ABPM) and urinary albumin-to-creatinine ratio (UACR). This analysis included 505 participants with complete ABPM and UACR data. This analysis combined across study arms as prespecified in the Study Protocol and Statistical Analysis Plan.||0.40|-0.21|0.54
72415685|NCT04307004|144342062|OTHER|Independent variable - asleep diastolic blood pressure on ABPM. Dependent variable - urinary albumin-to-creatinine ratio.|beta coefficient|0.26|STANDARD_ERROR_OF_MEAN|0.21||0.23|TWO_SIDED|95.0|-0.16|0.68|||Regression, Linear|||We determined the association between asleep diastolic blood pressure on ambulatory blood pressure monitoring (ABPM) and urinary albumin-to-creatinine ratio (UACR). This analysis included 505 participants with complete ABPM and UACR data. This analysis combined across study arms as prespecified in the Study Protocol and Statistical Analysis Plan.||0.68|-0.16|0.23
72596995|NCT03334422|144724984|SUPERIORITY|Overall Work Impairment|LSMean Difference|-9.13|STANDARD_ERROR_OF_MEAN|6.07||0.135|TWO_SIDED|95.0|-21.17|2.9|||Mixed Models Analysis|||Work Productivity Loss (Percentage Overall Work Impairment/Absenteeism Plus Presenteeism) Change from Baseline||2.90|-21.17|0.135
72596996|NCT03334422|144724984|SUPERIORITY||LSMean Difference|-2.26|STANDARD_ERROR_OF_MEAN|4.25||0.595|TWO_SIDED|95.0|-10.65|6.12|||Mixed Models Analysis|||Percentage of Activity Impairment Change from Baseline||6.12|-10.65|0.595
72596997|NCT03334422|144724984|SUPERIORITY||LSMean Difference|-14.3|STANDARD_ERROR_OF_MEAN|4.12|<|0.001|TWO_SIDED|95.0|-22.43|-6.17|||Mixed Models Analysis|||Percentage of Activity Impairment Change from Baseline||-6.17|-22.43|<0.001
72596998|NCT03334422|144724984|SUPERIORITY||LSMean Difference|-14.47|STANDARD_ERROR_OF_MEAN|3.88|<|0.001|TWO_SIDED|95.0|-22.11|-6.83|||Mixed Models Analysis|||Percentage of Activity Impairment Change from Baseline||-6.83|-22.11|<0.001
72596999|NCT03334422|144724985|SUPERIORITY||LSMean Difference|0.02|STANDARD_ERROR_OF_MEAN|0.02||0.295|TWO_SIDED|95.0|-0.02|0.07|||Mixed Models Analysis|||Health State Index Score (US Algorithm)||0.07|-0.02|0.295
72597000|NCT03334422|144724985|SUPERIORITY||LSMean Difference|0.08|STANDARD_ERROR_OF_MEAN|0.02||0.001|TWO_SIDED|95.0|0.03|0.12|||Mixed Models Analysis|||Health State Index Score (US Algorithm)||0.12|0.03|0.001
72597001|NCT03334422|144724985|SUPERIORITY||LSMean Difference|0.08|STANDARD_ERROR_OF_MEAN|0.02|<|0.001|TWO_SIDED|95.0|0.03|0.12|||Mixed Models Analysis|||Health State Index Score (US Algorithm)||0.12|0.03|<0.001
72597002|NCT03334422|144724985|SUPERIORITY||LSMean Difference|0.03|STANDARD_ERROR_OF_MEAN|0.03||0.334|TWO_SIDED|95.0|-0.03|0.1|||Mixed Models Analysis|||Health State Index Score (UK Algorithm)||0.10|-0.03|0.334
72597003|NCT03334422|144724985|SUPERIORITY||LSMean Difference|0.11|STANDARD_ERROR_OF_MEAN|0.03||0.001|TWO_SIDED|95.0|0.04|0.17|||Mixed Models Analysis|||Health State Index Score (UK Algorithm)||0.17|0.04|0.001
72597004|NCT03334422|144724985|SUPERIORITY||LSMean Difference|0.11|STANDARD_ERROR_OF_MEAN|0.03|<|0.001|TWO_SIDED|95.0|0.05|0.17|||Mixed Models Analysis|||Health State Index Score (UK Algorithm)||0.17|0.05|<0.001
72597005|NCT03334422|144724986|SUPERIORITY||LSMean Difference|0.4|STANDARD_ERROR_OF_MEAN|3.47||0.907|TWO_SIDED|95.0|-6.44|7.25|||Mixed Models Analysis|||EQ-5D-5L VAS Score||7.25|-6.44|0.907
72597006|NCT03334422|144724986|SUPERIORITY||LSMean Difference|8.19|STANDARD_ERROR_OF_MEAN|3.33||0.015|TWO_SIDED|95.0|1.63|14.76|||Mixed Models Analysis|||EQ-5D-5L VAS Score||14.76|1.63|0.015
72597007|NCT03334422|144724986|SUPERIORITY||LSMean Difference|8.82|STANDARD_ERROR_OF_MEAN|3.14||0.006|TWO_SIDED|95.0|2.62|15.01|||Mixed Models Analysis|||EQ-5D-5L VAS Score||15.01|2.62|0.006
72597008|NCT03334422|144724987|SUPERIORITY||Odds Ratio (OR)|0.93||||0.905|TWO_SIDED|95.0|0.3|2.93|||Regression, Logistic|||||2.93|0.30|0.905
72597009|NCT03334422|144724987|SUPERIORITY||Odds Ratio (OR)|2.37||||0.064|TWO_SIDED|95.0|0.95|5.92|||Regression, Logistic|||||5.92|0.95|0.064
72597010|NCT03334422|144724987|SUPERIORITY||Odds Ratio (OR)|5.14|||<|0.001|TWO_SIDED|95.0|2.25|11.74|||Regression, Logistic|||||11.74|2.25|<0.001
72597011|NCT01313221|144724996|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.16|STANDARD_ERROR_OF_MEAN|9.99|||TWO_SIDED|95.0|-3.5|35.82|||||Adjusted for treatment in a mixed model|||35.82|-3.50|
72597012|NCT01313221|144724997|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.23|STANDARD_ERROR_OF_MEAN|8.31|||TWO_SIDED|95.0|-5.13|27.6||||||Difference in change from Week 12 to Week 16||27.60|-5.13|
72597013|NCT01313221|144724997|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.56|STANDARD_ERROR_OF_MEAN|9.53|||TWO_SIDED|95.0|-2.21|35.32||||||Difference in change from Week 12 to Week 20||35.32|-2.21|
72597014|NCT04591015|144725027|SUPERIORITY|||||||0.0626|||||||Fisher Exact|||||||0.0626
72597015|NCT04591015|144725028|SUPERIORITY|||||||0.0496|||||||t-test, 2 sided|||Only includes participants who completed a 90-day lab||||0.0496
72597016|NCT04591015|144725029|SUPERIORITY|||||||0.0651|||||||t-test, 2 sided|||Only includes participants who completed a 180-day lab||||0.0651
72597017|NCT04591015|144725030|SUPERIORITY|||||||0.8739|||||||Fisher Exact|||||||0.8739
72597018|NCT04591015|144725031|SUPERIORITY|||||||0.4702|||||||t-test, 2 sided|||||||0.4702
72597019|NCT04591015|144725032|SUPERIORITY|||||||0.1258|||||||t-test, 2 sided|||||||0.1258
72597020|NCT04591015|144725033|SUPERIORITY|||||||0.8635|||||||t-test, 2 sided|||||||0.8635
72597021|NCT04591015|144725034|SUPERIORITY|||||||0.0471|||||||t-test, 2 sided|||||||0.0471
72597022|NCT04591015|144725035|SUPERIORITY|||||||0.0218|||||||t-test, 2 sided|||||||0.0218
72597023|NCT04591015|144725036|SUPERIORITY|||||||0.509|||||||t-test, 2 sided|||||||0.5090
72597024|NCT04591015|144725037|SUPERIORITY|||||||0.4034|||||||t-test, 2 sided|||||||0.4034
72597025|NCT04591015|144725038|SUPERIORITY|||||||0.0175|||||||t-test, 2 sided|||||||0.0175
72597026|NCT04591015|144725039|SUPERIORITY|||||||0.4435|||||||Fisher Exact|||||||0.4435
72597027|NCT04591015|144725040|SUPERIORITY|||||||0.7417|||||||Fisher Exact|||||||0.7417
72597028|NCT04591015|144725041|SUPERIORITY|||||||0.5779|||||||t-test, 2 sided|||||||0.5779
72597029|NCT04591015|144725042|SUPERIORITY|||||||0.0493|||||||t-test, 2 sided|||||||0.0493
72597030|NCT04591015|144725043|SUPERIORITY|||||||0.0773|||||||t-test, 2 sided|||||||0.0773
72597031|NCT04591015|144725044|SUPERIORITY|||||||0.0921|||||||t-test, 2 sided|||||||0.0921
72597032|NCT04591015|144725045|SUPERIORITY|||||||0.2404|||||||t-test, 2 sided|||||||0.2404
72597033|NCT04591015|144725046|SUPERIORITY|||||||0.8955|||||||t-test, 2 sided|||||||0.8955
72415686|NCT02195986|144342120|EQUIVALENCE|Bioequivalence was established for the primary endpoint if the 90% confidence interval for the difference of responder rates (test - reference) from baseline to Day 8 for the primary endpoint is contained within \[-0.20, 0.20\], using the per-protocol population.|Difference|-0.0062|||||TWO_SIDED|90.0|-0.1209|0.1084||||||The compound hypothesis to test was: H0: PT -PR \< -.20 or PT -PR \> .20 versus HA : -.20 ≤ PT -PR ≤ .20 Where PT = cure rate of test treatment, and PR = cure rate of reference treatment.||0.1084|-0.1209|
72597034|NCT02686814|144725062|EQUIVALENCE|Each of the scales, for each follow-up time compared to baseline, the null hypothesis that the median paired difference is zero will be tested against the two-sided alternative that the median is not zero. Wilcoxon signed-rank test will be used.|Median Difference (Final Values)|-0.9||||0.7646|TWO_SIDED||||||Wilcoxon signed-rank test|||3-6 Month compared to Baseline||||0.7646
72597035|NCT02686814|144725062|EQUIVALENCE|Each of the scales, for each follow-up time compared to baseline, the null hypothesis that the median paired difference is zero will be tested against the two-sided alternative that the median is not zero. Wilcoxon signed-rank test will be used.|Median Difference (Final Values)|3.9||||0.8984|TWO_SIDED||||||Wilcoxon signed-rank test|||1 Year compared to Baseline||||0.8984
72597036|NCT02686814|144725062|EQUIVALENCE|Each of the scales, for each follow-up time compared to baseline, the null hypothesis that the median paired difference is zero will be tested against the two-sided alternative that the median is not zero. Wilcoxon signed-rank test will be used.|Median Difference (Final Values)|0.0||||0.8457|TWO_SIDED||||||Wilcoxon signed-rank test|||2 Year compared to Baseline||||0.8457
72597037|NCT02686814|144725062|EQUIVALENCE|Each of the scales, for each follow-up time compared to baseline, the null hypothesis that the median paired difference is zero will be tested against the two-sided alternative that the median is not zero. Wilcoxon signed-rank test will be used.|Median Difference (Final Values)|-7.7||||0.1309|TWO_SIDED||||||Wilcoxon signed-rank test|||3 Year compared to Baseline||||0.1309
72597038|NCT02686814|144725062|EQUIVALENCE|Each of the scales, for each follow-up time compared to baseline, the null hypothesis that the median paired difference is zero will be tested against the two-sided alternative that the median is not zero. Wilcoxon signed-rank test will be used.|Median Difference (Final Values)|-15.2||||0.5|TWO_SIDED||||||Wilcoxon signed-rank test|||4 Year compared to Baseline||||0.5000
72597039|NCT02686814|144725063|EQUIVALENCE|Each of the scales, for each follow-up time compared to baseline, the null hypothesis that the median paired difference is zero will be tested against the two-sided alternative that the median is not zero. Wilcoxon signed-rank test will be used.|Median Difference (Final Values)|1.5||||0.2783|TWO_SIDED||||||Wilcoxon signed-rank test|||3-6 Month compared to Baseline||||0.2783
72597040|NCT02686814|144725063|EQUIVALENCE|Each of the scales, for each follow-up time compared to baseline, the null hypothesis that the median paired difference is zero will be tested against the two-sided alternative that the median is not zero. Wilcoxon signed-rank test will be used.|Median Difference (Final Values)|6.4||||0.0674|TWO_SIDED||||||Wilcoxon signed-rank test|||1 Year compared to Baseline||||0.0674
72597041|NCT02686814|144725063|EQUIVALENCE|Each of the scales, for each follow-up time compared to baseline, the null hypothesis that the median paired difference is zero will be tested against the two-sided alternative that the median is not zero. Wilcoxon signed-rank test will be used.|Median Difference (Final Values)|6.4||||0.0371|TWO_SIDED||||||Wilcoxon signed-rank test|||2 Year compared to Baseline||||0.0371
72597042|NCT02686814|144725063|EQUIVALENCE|Each of the scales, for each follow-up time compared to baseline, the null hypothesis that the median paired difference is zero will be tested against the two-sided alternative that the median is not zero. Wilcoxon signed-rank test will be used.|Median Difference (Final Values)|0.8||||0.6953|TWO_SIDED||||||Wilcoxon signed-rank test|||3 Year compared to Baseline||||0.6953
72597043|NCT02686814|144725063|EQUIVALENCE|Each of the scales, for each follow-up time compared to baseline, the null hypothesis that the median paired difference is zero will be tested against the two-sided alternative that the median is not zero. Wilcoxon signed-rank test will be used.|Median Difference (Final Values)|1.0|||>|0.9999|TWO_SIDED||||||Wilcoxon signed-rank test|||4 Year compared to Baseline||||>0.9999
72597044|NCT04767529|144725145|SUPERIORITY||percent difference|22.6||||0.025|TWO_SIDED|95.0|3.8|41.4||Threshold for significance set at p\<0.05|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusting for stratification factors was used for comparison between the EFX 28 mg and placebo group|% difference from placebo (efruxifermin 28 mg - placebo)|Comparison between proportion of participants in efruxifermin 28 mg group who met the primary endpoint vs the placebo group||41.4|3.8|0.025
72597045|NCT04767529|144725145|SUPERIORITY||percent difference|22.5||||0.036|TWO_SIDED|95.0|1.6|43.3||Threshold for significance was p\<0.05|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusting for stratification factors is used for comparison between the EFX 50 mg and placebo group|% difference from placebo (efruxifermin 50 mg - placebo)|Comparison between proportion of participants in efruxifermin 50 mg group who met the primary endpoint vs the placebo group||43.3|1.6|0.036
72597046|NCT04767529|144725146|SUPERIORITY||percent difference|21.8||||0.07|TWO_SIDED|95.0|-1.3|45.0||Threshold for significance set at p\<0.05|Cochran-Mantel-Haenszel|A Cochran-Mantel-Haenszel test adjusting for stratification factors was used for comparisons between the efruxifermin 28 mg and placebo group||||45.0|-1.3|0.070
72597047|NCT04767529|144725146|SUPERIORITY||percent difference|51.9|||<|0.001|TWO_SIDED|95.0|31.2|72.7||Threshold for significance set at p\<0.05|Cochran-Mantel-Haenszel|A Cochran-Mantel-Haenszel test adjusting for stratification factors was used for comparisons between the efruxifermin 50 mg and placebo group||Week 96||72.7|31.2|<0.001
72421600|NCT03720938|144354380|SUPERIORITY|||||||0.22||||||Linear mixed-effects model fit by maximum likelihood since restricted maximum likelihood assumes a strong normality.|Linear mixed-effects model|Adjusted for cluster effect in addition to baseline value and age.||Null hypothesis was the absence of difference between the two groups for the dependent variable fat ratio.||||0.220
72421601|NCT03720938|144354380|SUPERIORITY|||||||0.250006||||||Linear mixed-effects model fit by maximum likelihood since restricted maximum likelihood assumes a strong normality.|Linear mixed effects model|Adjusted by Satterthwaite's degrees of freedom method for cluster effect, and small sample sizes in addition to baseline value and age.||Null hypothesis was the absence of difference between the two groups for the dependent variable fat ratio.||||0.250006
72597048|NCT04767529|144725147|SUPERIORITY||percent difference|31.9||||0.002|TWO_SIDED|95.0|12.9|50.9||Threshold for significance set at p\<0.05|Cochran-Mantel-Haenszel|A Cochran-Mantel-Haenszel test adjusting for stratification factors was used for comparison between the efruxifermin 28 mg and placebo group||Week 24||50.9|12.9|0.002
72597049|NCT04767529|144725147|SUPERIORITY||percent difference|61.7|||<|0.001|TWO_SIDED|95.0|44.1|79.4||Threshold for significance set at p\<0.05|Cochran-Mantel-Haenszel|A Cochran-Mantel-Haenszel test adjusting for stratification factors was used for comparisons between the efruxifermin 50 mg and placebo groups||Week 24||79.4|44.1|<0.001
72597050|NCT04767529|144725147|SUPERIORITY||percent difference|38.9||||0.002|TWO_SIDED|95.0|17.2|60.7||Threshold for significance set at p\<0.05|Cochran-Mantel-Haenszel|A Cochran-Mantel-Haenszel test adjusting for stratification factors was used for comparisons between efruxifermin 28 mg and placebo groups||Week 96||60.7|17.2|0.002
72597051|NCT04767529|144725147|SUPERIORITY||percent difference|33.2||||0.006|TWO_SIDED|95.0|10.5|55.8||Threshold for significance set at p\<0.05|Cochran-Mantel-Haenszel|A Cochran-Mantel-Haenszel test adjusting for stratification factors was used for comparisons between the efruxifermin 50 mg and placebo group||Week 96||55.8|10.5|0.006
72597052|NCT04767529|144725148|SUPERIORITY||percent difference|20.0||||0.053|TWO_SIDED|95.0|0.4|39.5||Threshold for significance set at p\<0.05|Cochran-Mantel-Haenszel|A Cochran-Mantel-Haenszel test adjusting for stratification factors was used for comparisons between the efruxifermin 28 mg and placebo group||Week 24||39.5|0.4|0.053
72597053|NCT04767529|144725148|SUPERIORITY||percent difference|19.9||||0.069|TWO_SIDED|95.0|-1.5|41.2||Threshold for statistical significance set at p\<0.05|Cochran-Mantel-Haenszel|A Cochran-Mantel-Haenszel test adjusting for stratification factors was used for comparisons between the efruxifermin 50 mg and placebo groups||Week 24||41.2|-1.5|0.069
72597054|NCT04767529|144725148|SUPERIORITY||percent difference|19.0||||0.123|TWO_SIDED|95.0|-4.8|42.8||Threshold for significance set at p\<0.05|Cochran-Mantel-Haenszel|A Cochran-Mantel-Haenszel test adjusting for stratification factors was used for comparisons between the efruxifermin 28 mg and placebo groups||Week 96||42.8|-4.8|0.123
72597055|NCT04767529|144725148|SUPERIORITY||percent difference|49.0|||<|0.001|TWO_SIDED|95.0|27.7|70.2||Threshold for significance set at p\<0.05|Cochran-Mantel-Haenszel|A Cochran-Mantel-Haenszel test adjusting for stratification factors was used for comparisons between the efruxifermin 50 mg and placebo groups||Week 96||70.2|27.7|<0.001
72597056|NCT04767529|144725149|SUPERIORITY|Week 24|Mean Difference (Net)|-6.9|STANDARD_ERROR_OF_MEAN|1.1|<|0.001|TWO_SIDED|95.0|-9.09|-4.71||Threshold for significance set at p\<0.05|Mixed Models Analysis|MMRM: fixed effects of treatment, stratification factors, post-baseline visit, treatment-by-visit interaction and baseline as covariate for comparison||Percent change from baseline in hepatic fat fraction between the EFX 28 mg and placebo groups||-4.71|-9.09|<0.001
72597057|NCT04767529|144725149|SUPERIORITY|Week 24|Mean Difference (Net)|-9.2|STANDARD_ERROR_OF_MEAN|1.12|<|0.001|TWO_SIDED|95.0|-11.47|-7.02||Threshold for significance set at p\<0.05|Mixed Models Analysis|MMRM:fixed effects of treatment, stratification factors, post-baseline visit, treatment-by-visit interaction and baseline as covariates for comparison||Percent change from baseline in hepatic fat fraction between the EFX 50 mg and placebo groups||-7.02|-11.47|<0.001
72597058|NCT04767529|144725149|SUPERIORITY|Week 96|Mean Difference (Net)|-3.8|STANDARD_ERROR_OF_MEAN|1.31||0.005|TWO_SIDED|95.0|-6.39|-1.18||Threshold for significance set at p\<0.05|Mixed Models Analysis|MMRM:fixed effects of treatment, stratification factors, post-baseline visit, treatment-by-visit interaction and baseline as covariates for comparison||Percent change from baseline in hepatic fat fraction between the EFX 28 mg and placebo groups||-1.18|-6.39|0.005
72597059|NCT04767529|144725149|SUPERIORITY|Week 96|Mean Difference (Net)|-5.8|STANDARD_ERROR_OF_MEAN|1.29|<|0.001|TWO_SIDED|95.0|-8.38|-3.25||Threshold for significance set at p\<0.05|Mixed Models Analysis|MMRM:fixed effects of treatment, stratification factors, post-baseline visit, treatment-by-visit interaction and baseline as covariates for comparison||Percent change from baseline in hepatic fat fraction between the EFX 50 mg and placebo groups||-3.25|-8.38|<0.001
72597060|NCT04767529|144725150|SUPERIORITY|Week 24|Mean Difference (Net)|-51.6|STANDARD_ERROR_OF_MEAN|9.86|<|0.001|TWO_SIDED|95.0|-71.17|-32.11|||Mixed Models Analysis|||Treatment comparison of least squares (LS) mean change from baseline (EFX 28 mg - placebo) in triglycerides (mg/dL)||-32.11|-71.17|<0.001
72597061|NCT04767529|144725150|SUPERIORITY|Week 24|Mean Difference (Net)|-55.2|STANDARD_ERROR_OF_MEAN|9.83|<|0.001|TWO_SIDED|95.0|-74.63|-35.71|||Mixed Models Analysis|||Treatment comparison of least squares (LS) mean change from baseline (EFX 50 mg - placebo) in triglycerides (mg/dL)||-35.71|-74.63|<0.001
72597062|NCT04767529|144725150|SUPERIORITY|Week 96|Mean Difference (Net)|-43.0|STANDARD_ERROR_OF_MEAN|11.48|<|0.001|TWO_SIDED|95.0|-65.73|-20.27||Threshold for significance set at p\<0.05|Mixed Models Analysis||LS Means and differences, SEs, and p-values are from a MMRM with fixed effects of treatment, stratification factors, post-baseline visit, treatment-by-visit interaction, and baseline as a covariate for comparisons between the EFX and placebo group|Treatment comparison of least squares (LS) mean change from baseline (EFX 28 mg - placebo) in triglycerides (mg/dL)||-20.27|-65.73|<0.001
72415687|NCT02195986|144342121|SUPERIORITY|Superiority test of test product vs placebo|Difference|0.3766|||<|0.0001|TWO_SIDED|95.0|0.2743|0.479|||Chi-squared|||Both the test and reference products should both be statistically superior to placebo (p\<0.05, two-sided) using the Chi squared test with Yate's correction for the primary endpoint responder rate, using the ITT study population and last observation carried forward. The compound hypothesis to test was: H0: PT - PP ≤ 0 versus HA: PT - PP \> 0; Where PT = cure rate of test treatment, and PP = cure rate of placebo.||0.4790|0.2743|<0.0001
72415688|NCT02195986|144342121|SUPERIORITY|Superiority test of reference product vs placebo|Difference|0.3542|||<|0.0001|TWO_SIDED|95.0|0.257|0.4514|||Chi-squared|||Both the test and reference products should both be statistically superior to placebo (p\<0.05, two-sided) using the Chi squared test with Yate's correction for the primary endpoint responder rate, using the ITT study population and last observation carried forward. The compound hypothesis to test was: H0: PT - PP ≤ 0 versus HA: PT - PP \> 0; Where PT = cure rate of test treatment, and PP = cure rate of placebo.||0.4514|0.2570|<0.0001
72415689|NCT02195986|144342122|EQUIVALENCE|Bioequivalence was established for the secondary endpoint if the 90% confidence interval for the difference of responder rates (test - reference) from baseline to Day 8 for the secondary endpoint is contained within \[-0.20, 0.20\], using the per-protocol population.|Difference|0.05|||||TWO_SIDED|90.0|-0.0687|0.1686||||||||0.1686|-0.0687|
72415690|NCT02195986|144342123|SUPERIORITY|Superiority test of test product vs placebo|Difference|0.1387||||0.1092|TWO_SIDED|95.0|-0.028|0.3054|||Chi-squared|||Both the test and reference products should both be statistically superior to placebo (p\<0.05, two-sided) using the Chi squared test with Yate's correction for the secondary endpoint responder rate, using the ITT study population and last observation carried forward. The compound hypothesis to test was: H0: PT - PP ≤ 0 versus HA: PT - PP \> 0; Where PT = cure rate of test treatment, and PP = cure rate of placebo.||0.3054|-0.0280|0.1092
72597063|NCT04767529|144725150|SUPERIORITY|Week 96|Mean Difference (Net)|-47.8|STANDARD_ERROR_OF_MEAN|11.4|<|0.001|TWO_SIDED|95.0|-70.39|-25.24||Threshold for significance set at p\<0.05|Mixed Models Analysis||LS Means and differences, SEs, and p-values are from a MMRM with fixed effects of treatment, stratification factors, post-baseline visit, treatment-by-visit interaction, and baseline as a covariate for comparisons between the EFX and placebo group|Treatment comparison of LS mean change from baseline (EFX 50 mg - placebo) in triglycerides (mg/dL)||-25.24|-70.39|<0.001
72597064|NCT04767529|144725150|SUPERIORITY|Week 24|Mean Difference (Net)|11.0|STANDARD_ERROR_OF_MEAN|1.58|<|0.001|TWO_SIDED|95.0|7.92|14.17|||Mixed Models Analysis|||Treatment comparison of LS mean change from baseline (EFX 28 mg - placebo) in HDL cholesterol (mg/dL)||14.17|7.92|<0.001
72597065|NCT04767529|144725150|SUPERIORITY|Week 24|Mean Difference (Net)|12.5|STANDARD_ERROR_OF_MEAN|1.57|<|0.001|TWO_SIDED|95.0|9.35|15.57|||Mixed Models Analysis|||Treatment comparison of LS mean change from baseline (EFX 50 mg - placebo) in HDL cholesterol (mg/dL)||15.57|9.35|<0.001
72597066|NCT04767529|144725150|SUPERIORITY|Week 96|Mean Difference (Net)|6.0|STANDARD_ERROR_OF_MEAN|2.12||0.005|TWO_SIDED|95.0|1.84|10.23||Threshold for significance set at p\<0.05|Mixed Models Analysis||LS Means and differences, SEs, and p-values are from a MMRM with fixed effects of treatment, stratification factors, post-baseline visit, treatment-by-visit interaction, and baseline as a covariate for comparisons between the EFX and placebo group|Treatment comparison of LS mean change from baseline (EFX 28 mg - placebo) in HDL cholesterol (mg/dL)||10.23|1.84|0.005
72597067|NCT04767529|144725150|SUPERIORITY|Week 96|Mean Difference (Net)|9.5|STANDARD_ERROR_OF_MEAN|2.11|<|0.001|TWO_SIDED|95.0|5.3|13.65||Threshold for significance set at p\<0.05|Mixed Models Analysis||LS Means and differences, SEs, and p-values are from a MMRM with fixed effects of treatment, stratification factors, post-baseline visit, treatment-by-visit interaction, and baseline as a covariate for comparisons between the EFX and placebo group|Treatment comparison of LS mean change from baseline (EFX 50 mg - placebo) in HDL cholesterol (mg/dL)||13.65|5.30|<0.001
72597068|NCT04767529|144725150|SUPERIORITY|Week 24|Mean Difference (Net)|-14.4|STANDARD_ERROR_OF_MEAN|4.99||0.005|TWO_SIDED|95.0|-24.28|-4.53|||Mixed Models Analysis|||Treatment comparison of change from baseline (EFX 28 mg - placebo) in LDL cholesterol (mg/dL)||-4.53|-24.28|0.005
72597069|NCT04767529|144725150|SUPERIORITY|Week 24|Median Difference (Net)|-13.6|STANDARD_ERROR_OF_MEAN|4.98||0.007|TWO_SIDED|95.0|-23.5|-3.76|||Mixed Models Analysis|||Treatment comparison of LS mean change from baseline (EFX 50 mg - placebo) in LDL cholesterol (mg/dL)||-3.76|-23.50|0.007
72597070|NCT04767529|144725150|SUPERIORITY|Week 96|Mean Difference (Net)|0.1|STANDARD_ERROR_OF_MEAN|7.04||0.99|TWO_SIDED|95.0|-13.86|14.04||Threshold for significance set at p\<0.05|Mixed Models Analysis||LS Means and differences, SEs, and p-values are from a MMRM with fixed effects of treatment, stratification factors, post-baseline visit, treatment-by-visit interaction, and baseline as a covariate for comparisons between the EFX and placebo group|Treatment comparison of change from baseline (EFX 28 mg - placebo) in LDL cholesterol (mg/dL)||14.04|-13.86|0.990
72421602|NCT03720938|144354381|SUPERIORITY|||||||0||||||The outcome of visual reaction time was tested for any difference between groups by covariate analysis.|ANCOVA|Adjusted for the weight at baseline and confounding variable age.||Null hypothesis was the absence of difference between the two groups for the dependent variable visual reaction time.||||0.000
72597071|NCT04767529|144725150|SUPERIORITY|Week 96|Mean Difference (Net)|-0.2|STANDARD_ERROR_OF_MEAN|7.01||0.98|TWO_SIDED|95.0|-14.07|13.71||Threshold for significance set at p\<0.05|Mixed Models Analysis||LS Means and differences, SEs, and p-values are from a MMRM with fixed effects of treatment, stratification factors, post-baseline visit, treatment-by-visit interaction, and baseline as a covariate for comparisons between the EFX and placebo group|Treatment comparison of LS mean change from baseline (EFX 50 mg - placebo) in LDL cholesterol (mg/dL)||13.71|-14.07|0.980
72597072|NCT04767529|144725150|SUPERIORITY|Week 24|Mean Difference (Net)|-22.6|STANDARD_ERROR_OF_MEAN|5.52|<|0.001|TWO_SIDED|95.0|-33.58|-11.71|||Mixed Models Analysis|||Treatment comparison of LS mean change from baseline (EFX 28 mg - placebo) in non-HDL cholesterol (mg/dL)||-11.71|-33.58|<0.001
72597073|NCT04767529|144725150|SUPERIORITY|Week 24|Mean Difference (Net)|-22.7|STANDARD_ERROR_OF_MEAN|5.51|<|0.001|TWO_SIDED|95.0|-33.56|-11.74|||Mixed Models Analysis|||Treatment comparison of LS mean change from baseline (EFX 50mg - placebo) in non-HDL cholesterol (mg/dL)||-11.74|-33.56|<0.001
72597074|NCT04767529|144725150|SUPERIORITY|Week 96|Mean Difference (Net)|-6.1|STANDARD_ERROR_OF_MEAN|7.9||0.443|TWO_SIDED|95.0|-21.72|9.56||Threshold for significance set at p\<0.05|Mixed Models Analysis||LS Means and differences, SEs, and p-values are from a MMRM with fixed effects of treatment, stratification factors, post-baseline visit, treatment-by-visit interaction, and baseline as a covariate for comparisons between the EFX and placebo group|Treatment comparison of LS mean change from baseline (EFX 28 mg - placebo) in non-HDL cholesterol (mg/dL)||9.56|-21.72|0.443
72597075|NCT04767529|144725150|SUPERIORITY|Week 96|Mean Difference (Net)|-8.2|STANDARD_ERROR_OF_MEAN|7.86||0.299|TWO_SIDED|95.0|-23.77|7.36||Threshold for significance set at p\<0.05|Mixed Models Analysis||LS Means and differences, SEs, and p-values are from a MMRM with fixed effects of treatment, stratification factors, post-baseline visit, treatment-by-visit interaction, and baseline as a covariate for comparisons between the EFX and placebo group|Treatment comparison of LS mean change from baseline (EFX 50 mg - placebo) in non-HDL cholesterol (mg/dL)||7.36|-23.77|0.299
72597076|NCT04767529|144725159|SUPERIORITY|Week 24|Mean Difference (Net)|0.4|STANDARD_ERROR_OF_MEAN|1.18||0.75|TWO_SIDED|95.0|-1.96|2.72||Threshold for significance set at p\<0.05|Mixed Models Analysis|||Treatment comparison of LS mean change from baseline (EFX 28 mg - placebo) in body weight (kg)||2.72|-1.96|0.750
72597077|NCT04767529|144725159|SUPERIORITY|Week 24|Mean Difference (Net)|-2.4|STANDARD_ERROR_OF_MEAN|1.18||0.042|TWO_SIDED|95.0|-4.75|-0.09||Threshold for significance set at p\<0.05|Mixed Models Analysis|||Treatment comparison of LS mean change from baseline (EFX 50 mg - placebo) in body weight (kg)||-0.09|-4.75|0.042
72597078|NCT04767529|144725159|SUPERIORITY|Week 96|Mean Difference (Net)|1.2|STANDARD_ERROR_OF_MEAN|2.07||0.564|TWO_SIDED|95.0|-2.9|5.29|||Mixed Models Analysis|||Treatment comparison of LS mean change from baseline (28 mg EFX - placebo) in body weight (kg)||5.29|-2.90|0.564
72597079|NCT04767529|144725159|SUPERIORITY|Week 96|Mean Difference (Net)|-1.9|STANDARD_ERROR_OF_MEAN|2.06||0.348|TWO_SIDED|95.0|-6.02|2.14|||Mixed Models Analysis|||Treatment comparison of LS mean change from baseline (EFX 50 mg - placebo) in body weight (kg)||2.14|-6.02|0.348
72597080|NCT04767529|144725160|SUPERIORITY|Week 24|Mean Difference (Net)|-2.1|STANDARD_ERROR_OF_MEAN|1.24||0.102|TWO_SIDED|95.0|-4.5|0.4|||Mixed Models Analysis|||Treatment comparison of change from baseline (EFX 28 mg - placebo) in Liver Stiffness Measurement (kPa)||0.4|-4.5|0.102
72597081|NCT04767529|144725160|SUPERIORITY|Week 24|Mean Difference (Net)|-3.3|STANDARD_ERROR_OF_MEAN|1.26||0.009|TWO_SIDED|95.0|-5.8|-0.8|||Mixed Models Analysis|||Treatment comparison of change from baseline (EFX 50 mg - placebo) in Liver Stiffness Measurement (kPa)||-0.8|-5.8|0.009
72597082|NCT04767529|144725160|SUPERIORITY|Week 96|Mean Difference (Net)|-3.4|STANDARD_ERROR_OF_MEAN|1.43||0.021|TWO_SIDED|95.0|-6.2|-0.5||Threshold for significance set at P\<0.05|Mixed Models Analysis||LS Means, SEs, and p-values are from a MMRM with fixed effects of treatment, stratification factors, post-baseline visit, treatment-by-visit interaction, and baseline as a covariate for comparisons between the EFX 28 mg and placebo group|Treatment comparison of change from baseline (EFX 28 mg - placebo) in Liver Stiffness Measurement (kPa)||-0.5|-6.2|0.021
72597083|NCT04767529|144725160|SUPERIORITY|Week 96|Mean Difference (Net)|-6.6|STANDARD_ERROR_OF_MEAN|1.43|<|0.001|TWO_SIDED|95.0|-9.4|-3.7|||Mixed Models Analysis||LS Means, SEs, and p-values are from a MMRM with fixed effects of treatment, stratification factors, post-baseline visit, treatment-by-visit interaction, and baseline as a covariate for comparisons between the EFX 50 mg and placebo group|Treatment comparison of change from baseline (EFX 50 mg - placebo) in Liver Stiffness Measurement (kPa)||-3.7|-9.4|<0.001
72597084|NCT02722746|144725168|SUPERIORITY||percent difference|20.8||||0.165|TWO_SIDED|95.0|-8.9|47.3|||Z-test for proportions|||||47.3|-8.9|0.165
72597085|NCT02722746|144725168|SUPERIORITY||percent difference|14.4||||0.353|TWO_SIDED|95.0|-15.9|42.2|||Z-test for proportions|||||42.2|-15.9|0.353
72597086|NCT02722746|144725169|SUPERIORITY|||||||0.06|||||||Kruskal-Wallis|||For PACU spread||||0.06
72597087|NCT02722746|144725169|SUPERIORITY|||||||0.22|||||||Kruskal-Wallis|||For Pre-op spread||||0.22
72597088|NCT02722746|144725169|SUPERIORITY|||||||0.74|||||||Kruskal-Wallis|||For POD 1||||0.74
72597089|NCT02722746|144725170|SUPERIORITY|||||||0.551|||||||ANOVA|||||||0.551
72597090|NCT02722746|144725171|SUPERIORITY|||||||0.349|||||||Mixed Models Analysis|||||||0.349
72597091|NCT02722746|144725172|SUPERIORITY|||||||0.18|||||||Fisher Exact|||For Pruritis||||0.18
72597092|NCT02722746|144725172|SUPERIORITY|||||||0.44|||||||Fisher Exact|||For Nausea/Vomiting||||0.44
72597093|NCT02722746|144725172|SUPERIORITY|||||||0.74|||||||Fisher Exact|||For Respirartory Depression||||0.74
72597094|NCT02722746|144725176|SUPERIORITY|||||||0.524|||||||ANOVA|||For SBP||||0.524
72597095|NCT02722746|144725176|SUPERIORITY|||||||0.585|||||||ANOVA|||For DBP||||0.585
72597096|NCT02722746|144725176|SUPERIORITY|||||||0.199|||||||ANOVA|||For MAP||||0.199
72597097|NCT02722746|144725177|SUPERIORITY|||||||0.231|||||||Mixed Models Analysis|||||||0.231
72597098|NCT02722746|144725178|SUPERIORITY|||||||0.016|||||||ANOVA|||||||0.016
72415691|NCT02195986|144342123|SUPERIORITY|Superiority test of reference product vs placebo|Difference|0.1196||||0.1805|TWO_SIDED|95.0|-0.0491|0.2883|||Chi-squared|||Both the test and reference products should both be statistically superior to placebo (p\<0.05, two-sided) using the Chi squared test with Yate's correction for the secondary endpoint responder rate, using the ITT study population and last observation carried forward. The compound hypothesis to test was: H0: PT - PP ≤ 0 versus HA: PT - PP \> 0; Where PT = cure rate of test treatment, and PP = cure rate of placebo.||0.2883|-0.0491|0.1805
72415692|NCT02491671|144342153|SUPERIORITY||Risk Ratio (RR)|1.219||||0.171|TWO_SIDED|95.0|0.891|1.583|||Chi-squared|||||1.583|0.891|0.171
72415693|NCT02491671|144342154|SUPERIORITY||z|0.288|||>|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||"Wilcoxon rank-sum (Mann-Whitney) test Unadjusted variance 274999.00 Adjustment for ties --21069.78 Adjusted variance 253929.22 z = 0.288; Prob \> \|z\| = 0.7735"|||||>0.05
72415694|NCT02491671|144342155|SUPERIORITY||Risk Ratio (RR)|1.351||||0.307|TWO_SIDED|95.0|0.657|1.879|||Chi-squared|||||1.879|0.657|0 .307
72415695|NCT00535730|144342157|NON_INFERIORITY_OR_EQUIVALENCE|The power for the noninferiority hypothesis of VZV antibody titers is 92%. The noninferiority margin is the lower bound of the two-sided 95% confidence interval on the VZV antibody GMT ratio\[concomitant/nonconcomitant\] being \>0.67.||||||0.244||95.0||||The threshold for statistical significance is 0.025. There is no adjustment for multiple comparisons.|longitudinal regression model|Week 4 postvac, estimated responses, GMT ratio, 95% CI, p-value based on a longitudinal regression model adjusting for prevac titers and age (years)||The hypothesis was that the GMT of the VZV antibody responses at 4 weeks postvaccination in subjects who receive ZOSTAVAX™ concomitantly with PNEUMOVAX™ 23 will be noninferior to that in subjects who receive ZOSTAVAX™ nonconcomitantly||||0.244
72415696|NCT00535730|144342159|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The threshold for statistical significance is 0.025. There is no adjustment for multiple comparisons.|t-test, 1 sided|The one-sided p-value for testing acceptability for GMFR is computed based on t-test. CI is computed based on the t distribution||The hypothesis was that ZOSTAVAX™ elicits an acceptable VZV antibody response when administered concomitantly with PNEUMOVAX™ 23.||||<0.001
72415697|NCT00535730|144342160|NON_INFERIORITY_OR_EQUIVALENCE|The power for the noninferiority hypothesis regarding PnPs antibody titer is \~99%. The noninferiority margin is the lower bound of the two-sided 95% confidence interval (CI) on the PnPs antibody GMT ratio \[concomitant/nonconcomitant\] being \>05.|||||<|0.001||95.0||||The threshold for statistical significance is 0.025. There is no adjustment for multiple comparisons.|longitudinal regression model|Week 4 postvac, estimated responses, GMT ratio, 95% CI, p-value based on a longitudinal regression model adjusting for prevac titers and age (years)||"The hypothesis was that the GMT of the PnPs antibody response to serotype 3 at 4 weeks postvaccination in subjects who receive ZOSTAVAX™ concomitantly with PNEUMOVAX™ 23 will be noninferior to those in subjects who~receive ZOSTAVAX™ nonconcomitantly."||||<0.001
72415698|NCT00535730|144342161|NON_INFERIORITY_OR_EQUIVALENCE|The power for the noninferiority hypothesis regarding PnPs antibody titer is \~99%. The noninferiority margin is the lower bound of the two-sided 95% confidence interval (CI) on the PnPs antibody GMT ratio \[concomitant/nonconcomitant\] being \>05.|||||<|0.001||95.0||||The threshold for statistical significance is 0.025. There is no adjustment for multiple comparisons.|longitudinal regression model|Week 4 postvac, estimated responses, GMT ratio, 95% CI, p-value based on a longitudinal regression model adjusting for prevac titers and age (years)||The hypothesis was that the GMT of the PnPs antibody responses to serotype 14 at 4 weeks postvaccination in subjects who receive ZOSTAVAX™ concomitantly with PNEUMOVAX™ 23 will be noninferior to those in subjects who receive ZOSTAVAX™ nonconcomitantly.||||<0.001
72597099|NCT02722746|144725179|SUPERIORITY|||||||0.055|||||||ANOVA|||||||0.055
72597100|NCT02722746|144725180|SUPERIORITY|||||||0.567|||||||ANOVA|||||||0.567
72597101|NCT03706469|144725181|EQUIVALENCE|Bioequivalence in the AUClast will be concluded if the 90 percent (%) confidence interval for the test/reference ratio of the least squares means is fully contained within the acceptance range, 80.00% - 125.00%.|Percentage of Geometric Mean Ratio (GMR)|83.6|||||TWO_SIDED|90.0|74.5|93.8||||||||93.80|74.50|
72597102|NCT03706469|144725181|EQUIVALENCE|Bioequivalence in the AUClast will be concluded if the 90% confidence interval for the test/reference ratio of the least squares means is fully contained within the acceptance range, 80.00% - 125.00%.|Percentage of GMR|102.22|||||TWO_SIDED|90.0|91.1|114.7||||||||114.70|91.10|
72415699|NCT00535730|144342162|NON_INFERIORITY_OR_EQUIVALENCE|The power for the noninferiority hypothesis regarding PnPs antibody titer is \~99%. The noninferiority margin is the lower bound of the two-sided 95% confidence interval (CI) on the PnPs antibody GMT ratio \[concomitant/nonconcomitant\] being \>05.|||||<|0.001||95.0||||The threshold for statistical significance is 0.025. There is no adjustment for multiple comparisons.|longitudinal regression model|Week 4 postvac, estimated responses, GMT ratio, 95% CI, p-value based on a longitudinal regression model adjusting for prevac titers and age (years)||The hypothesis was that the GMT of the PnPs antibody responses to serotype 19A at 4 weeks postvaccination in subjects who receive ZOSTAVAX™ concomitantly with PNEUMOVAX™ 23 will be noninferior to those in subjects who receive ZOSTAVAX™ nonconcomitantly.||||<0.001
72597103|NCT03706469|144725181|EQUIVALENCE|Bioequivalence in the AUClast will be concluded if the 90% confidence interval for the test/reference ratio of the least squares means is fully contained within the acceptance range, 80.00% - 125.00%.|Percentage of GMR|172.73|||||TWO_SIDED|90.0|152.55|195.58||||||||195.58|152.55|
72597104|NCT03706469|144725182|EQUIVALENCE|Bioequivalence in the AUC∞ will be concluded if the 90% confidence interval for the test/reference ratio of the least squares means is fully contained within the acceptance range, 80.00% - 125.00%.|Percentage of GMR|84.29|||||TWO_SIDED|90.0|73.92|96.11||||||||96.11|73.92|
72597105|NCT03706469|144725182|EQUIVALENCE|Bioequivalence in the AUC∞ will be concluded if the 90% confidence interval for the test/reference ratio of the least squares means is fully contained within the acceptance range, 80.00% - 125.00%.|Percentage of GMR|99.61|||||TWO_SIDED|90.0|88.88|111.63||||||||111.63|88.88|
72597106|NCT03706469|144725182|EQUIVALENCE|Bioequivalence in the AUC∞ will be concluded if the 90% confidence interval for the test/reference ratio of the least squares means is fully contained within the acceptance range, 80.00% - 125.00%.|Percentage of GMR|172.7|||||TWO_SIDED|90.0|149.07|200.09||||||||200.09|149.07|
72597107|NCT03706469|144725183|EQUIVALENCE|Bioequivalence in the Cmax will be concluded if the 90% confidence interval for the test/reference ratio of the least squares means is fully contained within the acceptance range, 80.00% - 125.00%.|Percentage of GMR|79.14|||||TWO_SIDED|90.0|67.36|92.99||||||||92.99|67.36|
72597108|NCT03706469|144725183|EQUIVALENCE|Bioequivalence in the Cmax will be concluded if the 90% confidence interval for the test/reference ratio of the least squares means is fully contained within the acceptance range, 80.00% - 125.00%.|Percentage of GMR|99.8|||||TWO_SIDED|90.0|84.94|117.27||||||||117.27|84.94|
72597109|NCT03706469|144725183|EQUIVALENCE|Bioequivalence in the Cmax will be concluded if the 90% confidence interval for the test/reference ratio of the least squares means is fully contained within the acceptance range, 80.00% - 125.00%.|Percentage of GMR|173.3|||||TWO_SIDED|90.0|150.05|200.16||||||||200.16|150.05|
72597110|NCT02635009|144725185|SUPERIORITY|||||||0.28|||||||Fisher Exact|one-sided significance level = 0.05||Proportion of participants with deterioration in HVLT-R delayed recall score at six months: Null hypothesis = No difference between the arms; Alternative hypothesis = Arm 2 will have less deterioration than Arm 1. Ninety-eight evaluable participants per arm at six months provides 80% statistical power to detect a 14.5% absolute difference between the arms in proportion of participants with deterioration at six months using a one-sided Fisher's exact test.||||0.28
72597111|NCT02635009|144725186|NON_INFERIORITY|Null hypothesis: Proportion of participants with relapse on Arm 2 - Arm 1 \> 20%; Alternative hypothesis: Proportion of participants with relapse on Arm 2 - Arm 1 = 4.5%. Using a non-inferiority margin of 20% and an assumed difference in proportions of 4.5% under the alternative, a 2-sample test of difference in proportions with a 1-sided alpha of 0.1 requires 164 patients to achieve 85% statistical power. (Statistically significant p-value indicates non-inferiority.)||||||0.003|||||||Test of binomial proportions|||||||0.0030
72597112|NCT02635009|144725187|SUPERIORITY|||||||0.0598|||||||Gray's test|||||||0.0598
72597113|NCT02635009|144725188|SUPERIORITY|||||||0.78|||||||Chi-squared|||3 months||||0.78
72597114|NCT02635009|144725188|SUPERIORITY|||||||0.63|||||||Chi-squared|||6 months||||0.63
72597115|NCT02635009|144725188|SUPERIORITY|||||||0.84|||||||Chi-squared|||12 months||||0.84
72597116|NCT02635009|144725190|SUPERIORITY|||||||0.56|||||||Chi-squared|||3 months||||0.56
72597117|NCT02635009|144725190|SUPERIORITY|||||||0.75|||||||Chi-squared|||12 months||||0.75
72597118|NCT02635009|144725192|SUPERIORITY|||||||0.81|||||||Chi-squared|||3 months||||0.81
72597119|NCT02635009|144725192|SUPERIORITY|||||||0.93|||||||Chi-squared|||6 months||||0.93
72597120|NCT02635009|144725192|SUPERIORITY|||||||0.35|||||||Chi-squared|||12 months||||0.35
72597121|NCT02635009|144725194|SUPERIORITY|||||||0.54|||||||Chi-squared|||3 months||||0.54
72597122|NCT02635009|144725194|SUPERIORITY|||||||0.43|||||||Chi-squared|||6 months||||0.43
72597123|NCT02635009|144725194|SUPERIORITY|||||||0.25|||||||Chi-squared|||12 months||||0.25
72597124|NCT02635009|144725196|SUPERIORITY|||||||0.71|||||||Chi-squared|||3 months||||0.71
72597125|NCT02635009|144725196|SUPERIORITY|||||||0.079|||||||Chi-squared|||6 months||||0.079
72597126|NCT02635009|144725196|SUPERIORITY|||||||0.85|||||||Chi-squared|||12 months||||0.85
72597127|NCT02635009|144725198|SUPERIORITY|||||||0.043|||||||Chi-squared|||3 months||||0.043
72597128|NCT02635009|144725198|SUPERIORITY|||||||0.017|||||||Fisher Exact|||6 months||||0.017
72597129|NCT02635009|144725198|SUPERIORITY|||||||0.057|||||||Chi-squared|||12-month||||0.057
72597130|NCT02635009|144725201|SUPERIORITY|||||||0.1|||||||Chi-squared|||3 months||||0.10
72597131|NCT02635009|144725201|SUPERIORITY|||||||0.33|||||||Chi-squared|||6 months||||0.33
72597132|NCT02635009|144725201|SUPERIORITY|||||||0.29|||||||Chi-squared|||12 months||||0.29
72597133|NCT02635009|144725203|SUPERIORITY|||||||0.0021|||||||Chi-squared|||3 months||||0.0021
72597134|NCT02635009|144725203|SUPERIORITY|||||||0.007|||||||Chi-squared|||6 months||||0.0070
72597135|NCT02635009|144725203|SUPERIORITY|||||||0.35|||||||Chi-squared|||12 months||||0.35
72597136|NCT02635009|144725205|SUPERIORITY|||||||0.55|||||||Chi-squared|||3 months||||0.55
72597137|NCT02635009|144725205|SUPERIORITY|||||||0.062|||||||Chi-squared|||6 months||||0.062
72597138|NCT02635009|144725205|SUPERIORITY|||||||0.32|||||||Chi-squared|||12 months||||0.32
72597139|NCT02635009|144725207|SUPERIORITY|||||||0.7|||||||Chi-squared|||3 months||||0.70
72597140|NCT02635009|144725207|SUPERIORITY|||||||0.52|||||||Chi-squared|||6 months||||0.52
72597141|NCT02635009|144725207|SUPERIORITY|||||||0.73|||||||Chi-squared|||12 months||||0.73
72597142|NCT02635009|144725209|SUPERIORITY|||||||0.28|||||||Chi-squared|||3 months||||0.28
72597143|NCT02635009|144725209|SUPERIORITY|||||||0.094|||||||Chi-squared|||6 months||||0.094
72597144|NCT02635009|144725209|SUPERIORITY|||||||0.61|||||||Chi-squared|||||||0.61
72597145|NCT02635009|144725211|SUPERIORITY|||||||0.16|||||||Chi-squared|||3 months.||||0.16
72597146|NCT02635009|144725211|SUPERIORITY|||||||0.017|||||||Chi-squared|||6 months. Assuming 50% of patients experience deterioration at 6 months, based on a prior study (RTOG-0212), a sample size of 198 participants per arm provides 94% power to detect a 50% relative reduction (50% on Arm 1 vs. 25% on Arm 2) in decline at 6 months using Fisher's exact test with a two-sided alpha=0.05.||||0.017
72597147|NCT02635009|144725211|SUPERIORITY|||||||0.56|||||||Chi-squared|||12-month||||0.56
72597148|NCT02635009|144725213|SUPERIORITY|||||||0.44|||||||Chi-squared|||||||0.44
72597149|NCT02635009|144725213|SUPERIORITY|||||||0.45|||||||Chi-squared|||||||0.45
72597150|NCT02635009|144725213|SUPERIORITY|||||||0.25|||||||Chi-squared|||||||0.25
72597151|NCT02635009|144725215|SUPERIORITY|||||||0.35|||||||Chi-squared|||3 months||||0.35
72597152|NCT02635009|144725215|SUPERIORITY|||||||0.99|||||||Chi-squared|||6 months||||0.99
72597153|NCT02635009|144725215|SUPERIORITY|||||||0.94|||||||Chi-squared|||12 months||||0.94
72597154|NCT02635009|144725219|SUPERIORITY|||||||0.79||||||Two-side significance level = 0.05|Log Rank|||||||0.79
72597155|NCT02635009|144725220|SUPERIORITY|||||||0.93|||||||Gray's test|||||||0.93
72597156|NCT02636699|144725222|OTHER||Difference in Response Rates (%)|21.7|||<|0.001|TWO_SIDED|95.0|12.4|29.8|||Wald|||Analysis of the difference in response rates between DBV712 250 μg group and Placebo group and 2-sided Newcombe 95% confidence interval (CI). P-value was obtained from a 2-sided 5% test to evaluate the null hypothesis of no difference in response rates between treatment groups using the Wald method. Clinical relevance was evaluated based on the lower bound of the Newcombe 95% CI of the difference in response rates ≥15%.||29.8|12.4|<0.001
72597157|NCT02636699|144725223|OTHER||Difference in Response Rates (%)|19.0||||0.105|TWO_SIDED|95.0|-6.4|38.4|||Wald|||"Screening ED subgroup 1:~Analysis of the difference in response rates between DBV712 250 μg group and Placebo group and 2-sided Newcombe 95% CI. P-value was obtained from a 2-sided 5% test to evaluate the null hypothesis of no difference in response rates between treatment groups using the Wald method. Clinical relevance was evaluated based on the lower bound of the Newcombe 95% CI of the difference in response rates \>0."||38.4|-6.4|0.105
72597158|NCT02636699|144725223|OTHER||Difference in Response Rates (%)|22.3|||<|0.001|TWO_SIDED|95.0|12.1|30.8|||Wald|||"Screening ED subgroup 2:~Analysis of the difference in response rates between DBV712 250 μg group and Placebo group and 2-sided Newcombe 95% CI. P-value was obtained from a 2-sided 5% test to evaluate the null hypothesis of no difference in response rates between treatment groups using the Wald method. Clinical relevance was evaluated based on the lower bound of the Newcombe 95% CI of the difference in response rates \>0."||30.8|12.1|<0.001
72597159|NCT02636699|144725224|OTHER||Difference in Median CRD|297.0|||<|0.001|TWO_SIDED|95.0|130.0|317.0|||Wilcoxon rank-sum test|||The treatment effect was estimated using the Hodges-Lehmann estimate of the difference in median CRDs at Month 12.||317.0|130.0|<0.001
72597160|NCT01973335|144725231|SUPERIORITY||Mean Difference (Final Values)|30.0||||0.515|TWO_SIDED|95.0|-63.0|123.0||Not adjusted for multiple comparisons|t-test, 2 sided|||2x2 factorial design: both acetazolamide groups together are compared with both high-dose loop diuretic groups together||123|-63|0.515
72597161|NCT01973335|144725232|SUPERIORITY||Risk Difference (RD)|-0.2||||0.27|TWO_SIDED|||||Not adjusted for multiple comparisons|Fisher Exact|||2x2 factorial design: analysis according to spironolactone use||||0.270
72597162|NCT01636947|144725257|SUPERIORITY_OR_OTHER|||||||0.191|||||||Pearson's chi-square test|||||||0.191
72597163|NCT01636947|144725258|SUPERIORITY_OR_OTHER|||||||0.458|||||||Pearson's chi-square test|||Overall Stage p-value||||0.458
72597164|NCT03292471|144725303|SUPERIORITY|Dependent variable: PNT T-score Fixed Effects: Group Assignment (A = Standard, B= Priming), Time point (Pre-treatment, Post-treatment) Random Effects: Participant (intercept and slope) Priors for slope and intercept were set as t-distributions (PNT raw score converted to T-score scale with m = 50, sd = 10 based on sample estimates from Fergadiotis, Hula, \& Kellough, 2015)|Highest Density Interval of Posterior Di|0.284|||||TWO_SIDED|95.0|-2.07|2.92|||||Direction of comparison: Group A (Standard Protocol) and post-treatment timepoint were set as reference values|Baysian Multivariate Analysis of Variance||2.92|-2.07|
72597165|NCT03292471|144725303|SUPERIORITY|Dependent variable: PNT T-score Fixed Effects: Group Assignment (A = Standard, B= Priming), Time point (Pre-treatment, Follow-up) Random Effects: Participant (intercept and slope) Priors for slope and intercept were set as t-distributions (PNT raw score converted to T-score scale with m = 50, sd = 10 based on sample estimates from Fergadiotis, Hula, \& Kellough, 2015)|Highest Density Interval of Posterior Di|0.02|||||TWO_SIDED|95.0|-2.38|2.46|||||Direction of comparison: Group A (Standard Protocol) and follow-up (2 months post-treatment) timepoint were set as reference values|Baysian Multivariate Analysis of Variance||2.46|-2.38|
72597166|NCT03292471|144725304|SUPERIORITY|Dependent variable: CAT Mean-modality T-score Fixed Effects: Group Assignment (A = Standard, B= Priming), Time point (Entry, Exit) Random Effects: Participant (intercept and slope) Priors for slope and intercept were set as t-distributions|Highest Density Interval of Posterior Di|0.997|||||TWO_SIDED|95.0|-0.0719|2.25|||||Direction of comparison: Group A (Standard Protocol) and post-treatment timepoint were set as reference values|Baysian Multivariate Analysis of Variance||2.25|-0.0719|
72597167|NCT03292471|144725304|SUPERIORITY|Dependent variable: CAT Mean-modality T-score Fixed Effects: Group Assignment (A = Standard, B= Priming), Time-point (Pre-treatment, Post-treatment) Random Effects: Participant (intercept and slope) Priors for slope and intercept were set as t-distributions|Highest Density Interval of Posterior Di|0.443|||||TWO_SIDED|95.0|-0.596|1.58|||||Direction of comparison: Group A (Standard Protocol) and follow-up (2 months post-treatment) timepoint were set as reference values|Baysian Multivariate Analysis of Variance||1.58|-0.596|
72597168|NCT00911586|144725305|OTHER|Part 1 of piecewise linear regression model.|Slope|-4.077|STANDARD_ERROR_OF_MEAN|16.02||0.806|TWO_SIDED||||||Regression, Linear|Part 1 of piecewise linear regression model.|Part 1 of piecewise linear regression model.|||||0.8060
72597169|NCT00911586|144725306|OTHER|Part 2 of piecewise linear regression model.|Slope|4.114|STANDARD_ERROR_OF_MEAN|18.456||0.8286|TWO_SIDED||||||Regression, Linear|Part 2 of piecewise linear regression model.|Part 2 of piecewise linear regression model.|||||0.8286
72597170|NCT01017601|144725363|OTHER|||||||0.5|||||||Wilcoxon Rank Sum|||||||0.50
72597171|NCT01017601|144725364|OTHER|||||||0.96|||||||Wilcoxon Rank Sum|||||||0.96
72597172|NCT01017601|144725365|OTHER|||||||0.54|||||||Fisher Exact|||||||0.54
72597173|NCT01017601|144725366|OTHER|||||||1|||||||Fisher Exact|||||||1.0
72597174|NCT02051335|144725367|SUPERIORITY_OR_OTHER||LS mean difference|-0.31|STANDARD_ERROR_OF_MEAN|0.556||0.573|TWO_SIDED|95.0|-1.4|0.8||P-values were obtained using an ANOVA model with sequence, period, and treatment as fixed effects and participant nested within sequence as a random effect.|ANOVA|||||0.8|-1.4|0.573
72597175|NCT02051335|144725367|SUPERIORITY_OR_OTHER||LS mean difference|-0.7|STANDARD_ERROR_OF_MEAN|0.55||0.21|TWO_SIDED|95.0|-1.8|0.4||P-values were obtained using an ANOVA model with sequence, period, and treatment as fixed effects and participant nested within sequence as a random effect.|ANOVA|||||0.4|-1.8|0.210
72597176|NCT02051335|144725367|SUPERIORITY_OR_OTHER||LS mean difference|0.12|STANDARD_ERROR_OF_MEAN|0.547||0.821|TWO_SIDED|95.0|-1.0|1.2||P-values were obtained using an ANOVA model with sequence, period, and treatment as fixed effects and participant nested within sequence as a random effect.|ANOVA|||||1.2|-1.0|0.821
72597177|NCT02051335|144725367|SUPERIORITY_OR_OTHER||LS mean difference|0.44|STANDARD_ERROR_OF_MEAN|0.549||0.426|TWO_SIDED|95.0|-0.7|1.5||P-values were obtained using an ANOVA model with sequence, period, and treatment as fixed effects and participant nested within sequence as a random effect.|ANOVA|||||1.5|-0.7|0.426
72597178|NCT02051335|144725367|SUPERIORITY_OR_OTHER||LS mean difference|0.82|STANDARD_ERROR_OF_MEAN|0.53||0.126|TWO_SIDED|95.0|-0.2|1.9||P-values were obtained using an ANOVA model with sequence, period, and treatment as fixed effects and participant nested within sequence as a random effect.|ANOVA|||||1.9|-0.2|0.126
72597179|NCT02051335|144725368|SUPERIORITY_OR_OTHER||LS mean difference|1.93|STANDARD_ERROR_OF_MEAN|0.992||0.057|TWO_SIDED|95.0|-0.1|3.9||P-values were obtained using an ANOVA model with sequence, period, and treatment as fixed effects and participant nested within sequence as a random effect.|ANOVA|||||3.9|-0.1|0.057
72597180|NCT02051335|144725368|SUPERIORITY_OR_OTHER||LS mean difference|-0.84|STANDARD_ERROR_OF_MEAN|0.981||0.394|TWO_SIDED|95.0|-2.8|1.1||P-values were obtained using an ANOVA model with sequence, period, and treatment as fixed effects and participant nested within sequence as a random effect.|ANOVA|||||1.1|-2.8|0.394
72597181|NCT02051335|144725368|SUPERIORITY_OR_OTHER||LS mean difference|2.01|STANDARD_ERROR_OF_MEAN|0.972||0.042|TWO_SIDED|95.0|0.1|4.0||P-values were obtained using an ANOVA model with sequence, period, and treatment as fixed effects and participant nested within sequence as a random effect.|ANOVA|||||4.0|0.1|0.042
72597182|NCT02051335|144725368|SUPERIORITY_OR_OTHER||LS mean difference|0.09|STANDARD_ERROR_OF_MEAN|0.974||0.928|TWO_SIDED|95.0|-1.9|2.0||P-values were obtained using an ANOVA model with sequence, period, and treatment as fixed effects and participant nested within sequence as a random effect.|ANOVA|||||2.0|-1.9|0.928
72597183|NCT02051335|144725368|SUPERIORITY_OR_OTHER||LS mean difference|2.86|STANDARD_ERROR_OF_MEAN|0.943||0.004|TWO_SIDED|95.0|1.0|4.7||P-values were obtained using an ANOVA model with sequence, period, and treatment as fixed effects and participant nested within sequence as a random effect.|ANOVA|||||4.7|1.0|0.004
72421603|NCT03720938|144354381|SUPERIORITY|Adjusted for the weight at baseline and confounding variable age.||||||1.196e-05||||||Linear mixed-effects model fit by maximum likelihood since restricted maximum likelihood assumes a strong normality.|Linear mixed-effects model|Adjusted for cluster effect in addition to baseline value and age.||The outcome of visual reaction time was tested for any difference between groups by linear mixed-effects model analysis.||||0.00001196
72597184|NCT02638259|144725385|EQUIVALENCE|A margin of 0.6 can be statistically and clinically justified based on the results Keystone et al, Arthritis and Rheumatism, p353-363, (2004) and on the EULAR response criteria. The sample size of 155 per group with 90% power is based on the common SD of 1.46 and was calculated using nQuery 7.0.|Mean Difference (Final Values)|-0.07|STANDARD_ERROR_OF_MEAN|0.097|||TWO_SIDED|95.0|-0.26|0.12||||||Therapeutic equivalence in terms of change from baseline in DAS28-CRP at week 24 will be concluded if the 95% confidence interval for the LS mean difference between GP2015 and Enbrel is contained within the interval \[-0.6; 0.6\]. A mixed-model repeated measures analysis was performed for DAS28-CRP change from baseline including treatment, stratification factors, time, the interaction between time (visits) and treatment all as categorical variables, and baseline DAS28-CRP as a continuous variable.||0.12|-0.26|
72597185|NCT02952872|144725432|SUPERIORITY||||||<|0.05|||||||ANOVA|Mixed Design ANOVA||||||<.05
72597186|NCT02952872|144725433|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<.05
72597187|NCT02952872|144725434|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<.05
72597188|NCT02952872|144725435|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<.05
72597189|NCT01969084|144725443|SUPERIORITY_OR_OTHER||||||>|0.05||||||A p-value of \< 0.05 was considered statistically significant|Wilcoxon (Mann-Whitney)|||Data were expressed as the median (25th:75th percentiles) for non-normally distributed data. The mean±sd for the groups was not analyzed as per the statistical plan.||||>0.05
72597190|NCT04114656|144725470|OTHER||Posterior Ratio to placebo|0.993|||||TWO_SIDED|95.0|0.968|1.02|||||Treatment comparison ratio of GSK3858279 and placebo using posterior median ratio and 95% credible interval is presented. Analysis was performed using Bayesian Mixed Repeated measures Analysis of Covariance (ANCOVA) model.|||1.020|0.968|
72597191|NCT04114656|144725471|OTHER||Posterior ratio to placebo|1.0|||||TWO_SIDED|95.0|0.89|1.12|||||Treatment comparison ratio of GSK3858279 and placebo using posterior median ratio and 95% credible interval is presented. Analysis was performed using Bayesian Mixed Repeated measures Analysis of Covariance (ANCOVA) model.|||1.12|0.89|
72597192|NCT04114656|144725472|OTHER||Posterior ratio to placebo|0.98|||||TWO_SIDED|95.0|0.91|1.05|||||Treatment comparison ratio of GSK3858279 and placebo using posterior median ratio and 95% credible interval is presented. Analysis was performed using Bayesian Mixed Repeated measures Analysis of Covariance (ANCOVA) model.|||1.05|0.91|
72597193|NCT03282591|144725486|SUPERIORITY||Mean Difference (Final Values)|31.4||||0.9942|ONE_SIDED|95.0||56.9|||Mixed Models Analysis|||||56.9||0.9942
72597194|NCT01716520|144725543|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.121|||<|0.001|TWO_SIDED|95.0|0.085|0.157||Analysis was performed using an Analysis of Covariance (ANCOVA) model with covariates of treatment, period, mean Baseline, period Baseline, response type and treatment by response type interaction.|ANCOVA||Responders to UMEC=responders to UMEC or to both monotherapies, as defined by a participant with an increase from Baseline of \>=12% and 200 milliliters (mL) at \>=1 time point over 0-6 hours post-dose in FEV1 on Day 1.|||0.157|0.085|<0.001
72597195|NCT01716520|144725543|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.135|||<|0.001|TWO_SIDED|95.0|0.1|0.171||Analysis was performed using an Analysis of Covariance (ANCOVA) model with covariates of treatment, period, mean Baseline, period Baseline, response type and treatment by response type interaction.|ANCOVA||Responders to UMEC=responders to UMEC or to both monotherapies, as defined by a participant with an increase from Baseline of \>=12% and 200 mL at \>=1 time point over 0-6 hours post-dose in FEV1 on Day 1.|||0.171|0.100|<0.001
72597196|NCT01716520|144725543|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.142|||<|0.001|TWO_SIDED|95.0|0.11|0.174||Analysis was performed using an Analysis of Covariance (ANCOVA) model with covariates of treatment, period, mean Baseline, period Baseline, response type and treatment by response type interaction.|ANCOVA||Responders to VI=responders to VI or to both monotherapies, as defined by a participant with an increase from Baseline of \>=12% and 200 mL at \>=1 time point over 0-6 hours post-dose in FEV1 on Day 1.|||0.174|0.110|<0.001
72597197|NCT01716520|144725543|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.098|||<|0.001|TWO_SIDED|95.0|0.067|0.13||Analysis was performed using an Analysis of Covariance (ANCOVA) model with covariates of treatment, period, mean Baseline, period Baseline, response type and treatment by response type interaction.|ANCOVA||Responders to VI=responders to VI or to both monotherapies, as defined by a participant with an increase from Baseline of \>=12% and 200 mL at \>=1 time point over 0-6 hours post-dose in FEV1 on Day 1.|||0.130|0.067|<0.001
72597198|NCT01716520|144725543|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.052||||0.047|TWO_SIDED|95.0|0.001|0.104||Analysis was performed using an Analysis of Covariance (ANCOVA) model with covariates of treatment, period, mean Baseline, period Baseline, response type and treatment by response type interaction.|ANCOVA||Responders to Neither=responders to neither UMEC nor VI, as defined by a participant with at least one FEV1 assessment over 0-6 hours post-dose on Day 1 but no increase from Baseline of \>=12% and 200 mL at any assessment(s).|||0.104|0.001|0.047
72597199|NCT01716520|144725543|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.073||||0.006|TWO_SIDED|95.0|0.021|0.124||Analysis was performed using an Analysis of Covariance (ANCOVA) model with covariates of treatment, period, mean Baseline, period Baseline, response type and treatment by response type interaction.|ANCOVA||Responders to Neither=responders to neither UMEC nor VI, as defined by a participant with at least one FEV1 assessment over 0-6 hours post-dose on Day 1 but no increase from Baseline of \>=12% and 200 mL at any assessment(s).|||0.124|0.021|0.006
72597200|NCT01937884|144725564|SUPERIORITY|||||||0.57|||||||Wilcoxon (Mann-Whitney)|||||||0.57
72597201|NCT01937884|144725565|SUPERIORITY|||||||0.68|||||||Wilcoxon (Mann-Whitney)|||||||0.68
72597202|NCT01937884|144725566|SUPERIORITY|||||||0.27|||||||t-test, 2 sided|Student's t-test on log-transformed change in IFABP.||||||0.27
72597203|NCT01937884|144725567|SUPERIORITY|||||||0.04|||||||t-test, 2 sided|Student's t-test on log-transformed citrulline concentration on study day 5, by treatment group||||||0.04
72597204|NCT01937884|144725568|SUPERIORITY|||||||0.43|||||||t-test, 2 sided|Student's t-test on log-transformed percent change of claudin 3||||||0.43
72597205|NCT01937884|144725569|SUPERIORITY|||||||0.88|||||||Wilcoxon (Mann-Whitney)|||||||0.88
72597206|NCT01937884|144725570|SUPERIORITY|||||||0.43|||||||Chi-squared|||||||0.43
72597207|NCT01937884|144725571|SUPERIORITY|||||||0.06|||||||Chi-squared|||||||0.06
72597208|NCT00981058|144725578|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.842||||0.012|TWO_SIDED|95.0|0.736|0.962|||Log Rank|||||0.962|0.736|0.0120
72597209|NCT00981058|144725579|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.851||||0.0201|TWO_SIDED|95.0|0.743|0.975|||Log Rank|||||0.975|0.743|0.0201
72597210|NCT00981058|144725580|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.12||||0.3997|TWO_SIDED|95.0|0.86|1.45|||Cochran-Mantel-Haenszel|||||1.45|0.86|0.3997
72597211|NCT00981058|144725581|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.844||||0.0061|TWO_SIDED|95.0|0.747|0.953|||Log Rank|||||0.953|0.747|0.0061
72597212|NCT02667587|144725587|SUPERIORITY||Cox Proportional Hazard|1.06|||||TWO_SIDED|95.0|0.9|1.25||||||||1.25|0.90|
72597213|NCT02667587|144725588|SUPERIORITY||Cox Proportional Hazard|1.12||||0.3402|TWO_SIDED|96.39|0.87|1.43|||Log Rank|||All Randomized No Baseline Corticosteroids Participants||1.43|0.87|0.3402
72597214|NCT02667587|144725588|SUPERIORITY||Cox Proportional Hazard|1.1|||||TWO_SIDED|95.0|0.91|1.33||||||All Randomized Participants||1.33|0.91|
72597215|NCT02667587|144725592|SUPERIORITY||Cox Proportional Hazard|1.18|||||TWO_SIDED|95.0|0.99|1.4||||||||1.40|0.99|
72597216|NCT02667587|144725593|SUPERIORITY||Cox Proportional Hazard|1.06|||||TWO_SIDED|95.0|0.89|1.26|||Log Rank|||||1.26|0.89|
72597217|NCT01134263|144725594|EQUIVALENCE|Lot consistency for each pair of lots was demonstrated if, for each pair of lots and each serotype the lower limit of the 95% CI was \> -0.301 and the upper limit was \< 0.301.|Difference of Log10 GMT|0.055|||||TWO_SIDED|95.0|-0.067|0.178||||||Dengue Virus Serotype 1: Phase III Lot 1 vs Lot 2||0.178|-0.067|
72597218|NCT01134263|144725594|EQUIVALENCE|Lot consistency for each pair of lots was demonstrated if, for each pair of lots and each serotype the lower limit of the 95% CI was \> -0.301 and the upper limit was \< 0.301.|Difference of Log10 GMT|0.024|||||TWO_SIDED|95.0|-0.102|0.151||||||Dengue Virus Serotype 1: Phase III Lot 2 vs Lot 3||0.151|-0.102|
72597219|NCT01134263|144725594|EQUIVALENCE|Lot consistency for each pair of lots was demonstrated if, for each pair of lots and each serotype the lower limit of the 95% CI was \> -0.301 and the upper limit was \< 0.301.|Difference of Log10 GMT|-0.08|||||TWO_SIDED|95.0|-0.204|0.045||||||Dengue Virus Serotype 1: Phase III Lot 3 vs Lot 1||0.045|-0.204|
72597220|NCT01134263|144725594|EQUIVALENCE|Lot consistency for each pair of lots was demonstrated if, for each pair of lots and each serotype the lower limit of the 95% CI was \> -0.301 and the upper limit was \< 0.301.|Difference of Log10 GMT|0.174|||||TWO_SIDED|95.0|0.009|0.34||||||Dengue Virus Serotype 2: Phase III Lot 1 vs Lot 2||0.340|0.009|
72597221|NCT01134263|144725594|EQUIVALENCE|Lot consistency for each pair of lots was demonstrated if, for each pair of lots and each serotype the lower limit of the 95% CI was \> -0.301 and the upper limit was \< 0.301.|Difference of Log10 GMT|-0.12|||||TWO_SIDED|95.0|-0.297|0.056||||||Dengue Virus Serotype 2: Phase III Lot 2 vs Lot 3||0.056|-0.297|
72597222|NCT01134263|144725594|EQUIVALENCE|Lot consistency for each pair of lots was demonstrated if, for each pair of lots and each serotype the lower limit of the 95% CI was \> -0.301 and the upper limit was \< 0.301.|Difference of Log10 GMT|-0.054|||||TWO_SIDED|95.0|-0.225|0.117||||||Dengue Virus Serotype 2: Phase III Lot 3 vs Lot 1||0.117|-0.225|
72597223|NCT01134263|144725594|EQUIVALENCE|Lot consistency for each pair of lots was demonstrated if, for each pair of lots and each serotype the lower limit of the 95% CI was \> -0.301 and the upper limit was \< 0.301.|Difference of Log10 GMT|0.058|||||TWO_SIDED|95.0|-0.068|0.184||||||Dengue Virus Serotype 3: Phase III Lot 1 vs Lot 2||0.184|-0.068|
72597224|NCT01134263|144725594|EQUIVALENCE|Lot consistency for each pair of lots was demonstrated if, for each pair of lots and each serotype the lower limit of the 95% CI was \> -0.301 and the upper limit was \< 0.301.|Difference of Log10 GMT|-0.042|||||TWO_SIDED|95.0|-0.167|0.082||||||Dengue Virus Serotype 3: Phase III Lot 2 vs Lot 3||0.082|-0.167|
72597225|NCT01134263|144725594|EQUIVALENCE|Lot consistency for each pair of lots was demonstrated if, for each pair of lots and each serotype the lower limit of the 95% CI was \> -0.301 and the upper limit was \< 0.301.|Difference of Log10 GMT|-0.016|||||TWO_SIDED|95.0|-0.144|0.113||||||Dengue Virus Serotype 3: Phase III Lot 3 vs Lot 1||0.113|-0.144|
72597226|NCT01134263|144725594|EQUIVALENCE|Lot consistency for each pair of lots was demonstrated if, for each pair of lots and each serotype the lower limit of the 95% CI was \> -0.301 and the upper limit was \< 0.301.|Difference of Log10 GMT|0.144|||||TWO_SIDED|95.0|-0.006|0.295||||||Dengue Virus Serotype 4: Phase III Lot 1 vs Lot 2||0.295|-0.006|
72597227|NCT01134263|144725594|EQUIVALENCE|Lot consistency for each pair of lots was demonstrated if, for each pair of lots and each serotype the lower limit of the 95% CI was \> -0.301 and the upper limit was \< 0.301.|Difference of Log10 GMT|-0.06|||||TWO_SIDED|95.0|-0.207|0.088||||||Dengue Virus Serotype 4: Phase III Lot 2 vs Lot 3||0.088|-0.207|
72597228|NCT01134263|144725594|EQUIVALENCE|Lot consistency for each pair of lots was demonstrated if, for each pair of lots and each serotype the lower limit of the 95% CI was \> -0.301 and the upper limit was \< 0.301.|Difference of Log10 GMT|-0.085|||||TWO_SIDED|95.0|-0.242|0.073||||||Dengue Virus Serotype 4: Phase III Lot 3 vs Lot 1||0.073|-0.242|
72597229|NCT01134263|144725595|EQUIVALENCE|Equivalence between the pooled Phase III and Phase II was demonstrated if, for each serotype the lower limit of the 95%CI was \> -0.301 and the upper limit was \< 0.301.|Difference of Log10 GMT|0.091|||||TWO_SIDED|95.0|-0.009|0.192||||||Dengue Virus Serotype 1||0.192|-0.009|
72597230|NCT01134263|144725595|EQUIVALENCE|Equivalence between the pooled Phase III and Phase II was demonstrated if, for each serotype the lower limit of the 95%CI was \> -0.301 and the upper limit was \< 0.301.|Difference of Log10 GMT|0.334|||||TWO_SIDED|95.0|0.202|0.466||||||Dengue Virus Serotype 2||0.466|0.202|
72597231|NCT01134263|144725595|EQUIVALENCE|Equivalence between the pooled Phase III and Phase II was demonstrated if, for each serotype the lower limit of the 95%CI was \> -0.301 and the upper limit was \< 0.301.|Difference of Log10 GMT|-0.076|||||TWO_SIDED|95.0|-0.173|0.021||||||Dengue Virus Serotype 3||0.021|-0.173|
72597232|NCT01134263|144725595|EQUIVALENCE|Equivalence between the pooled Phase III and Phase II was demonstrated if, for each serotype the lower limit of the 95%CI was \> -0.301 and the upper limit was \< 0.301.|Difference of Log10 GMT|-0.017|||||TWO_SIDED|95.0|-0.137|0.103||||||Dengue Virus Serotype 4||0.103|-0.137|
72597233|NCT04165135|144725598|OTHER|||||||0.763|||||||Kruskal-Wallis|||Heart zone minutes: Comparison among the age groups was performed by means of a Kruskal-Wallis test.||||0.7630
72597234|NCT04165135|144725598|OTHER|||||||0.0913|||||||Kruskal-Wallis|||Active zone minutes: Comparison among age groups was performed using Kruskal-Wallis test.||||0.0913
72597235|NCT04165135|144725598|OTHER|||||||0.0956|||||||Kruskal-Wallis|||MVPA minutes: Comparison among age groups was performed using Kruskal-Wallis test.||||0.0956
72597236|NCT04165135|144725599|OTHER|||||||0.0649|||||||Kruskal-Wallis|||||||0.0649
72597237|NCT04165135|144725600|OTHER|||||||0.0026|||||||Kruskal-Wallis|||||||0.0026
72597238|NCT04165135|144725601|OTHER|||||||0.9493|||||||Kruskal-Wallis|||Running: Comparison among age groups was performed using Kruskal-Wallis test.||||0.9493
72597239|NCT04165135|144725601|OTHER|||||||0.8305|||||||Kruskal-Wallis|||Swimming: Comparison among age groups was performed using Kruskal-Wallis test.||||0.8305
72597240|NCT04165135|144725601|OTHER|||||||0.8725|||||||Kruskal-Wallis|||Tapis Roulant: Comparison among age groups was performed using Kruskal-Wallis test.||||0.8725
72597241|NCT04165135|144725601|OTHER|||||||0.338|||||||Kruskal-Wallis|||Gym Weights: Comparison among age groups was performed using Kruskal-Wallis test.||||0.3380
72597242|NCT04165135|144725601|OTHER|||||||0.9706|||||||Kruskal-Wallis|||Exercises at Intervals: Comparison among age groups was performed using Kruskal-Wallis test.||||0.9706
72597243|NCT04165135|144725601|OTHER|||||||0.1727|||||||Kruskal-Wallis|||General: Comparison among age groups was performed using Kruskal-Wallis test.||||0.1727
72597244|NCT04165135|144725601|OTHER|||||||0.0099|||||||Kruskal-Wallis|||Walk: Comparison among age groups was performed using Kruskal-Wallis test.||||0.0099
72597245|NCT04165135|144725602|OTHER|||||||0.6151|||||||Kruskal-Wallis|||Running: Comparison among age groups was performed using Kruskal-Wallis test.||||0.6151
72597246|NCT04165135|144725602|OTHER|||||||0.9332|||||||Kruskal-Wallis|||Swimming: Comparison among age groups was performed using Kruskal-Wallis test.||||0.9332
72597247|NCT04165135|144725602|OTHER|||||||0.4726|||||||Kruskal-Wallis|||Tapis Roulant: Comparison among age groups was performed using Kruskal-Wallis test.||||0.4726
72597248|NCT04165135|144725602|OTHER|||||||0.4111|||||||Kruskal-Wallis|||Gym Weights: Comparison among age groups was performed using Kruskal-Wallis test.||||0.4111
72597249|NCT04165135|144725602|OTHER|||||||0.0892|||||||Kruskal-Wallis|||Exercises at Intervals: Comparison among age groups was performed using Kruskal-Wallis test.||||0.0892
72597250|NCT04165135|144725602|OTHER|||||||0.1642|||||||Kruskal-Wallis|||General: Comparison among age groups was performed using Kruskal-Wallis test.||||0.1642
72597251|NCT04165135|144725602|OTHER|||||||0.7256|||||||Kruskal-Wallis|||Walk: Comparison among age groups was performed using Kruskal-Wallis test.||||0.7256
72597252|NCT04165135|144725603|OTHER|||||||0.0745|||||||Kruskal-Wallis|||Running: Comparison among age groups was performed using Kruskal-Wallis test.||||0.0745
72597253|NCT04165135|144725603|OTHER|||||||0.2177|||||||Kruskal-Wallis|||Swimming: Comparison among age groups was performed using Kruskal-Wallis test.||||0.2177
72597254|NCT04165135|144725603|OTHER|||||||0.2121|||||||Kruskal-Wallis|||Tapis Roulant: Comparison among age groups was performed using Kruskal-Wallis test.||||0.2121
72597255|NCT04165135|144725603|OTHER|||||||0.2336|||||||Kruskal-Wallis|||Gym weights: Comparison among age groups was performed using Kruskal-Wallis test.||||0.2336
72597256|NCT04165135|144725603|OTHER|||||||0.419|||||||Kruskal-Wallis|||Exercises at intervals: Comparison among age groups was performed using Kruskal-Wallis test.||||0.4190
72597257|NCT04165135|144725603|OTHER|||||||0.0252|||||||Kruskal-Wallis|||General: Comparison among age groups was performed using Kruskal-Wallis test.||||0.0252
72597258|NCT04165135|144725603|OTHER|||||||0.2143|||||||Kruskal-Wallis|||Walk: Comparison among age groups was performed using Kruskal-Wallis test.||||0.2143
72597259|NCT04165135|144725604|OTHER|||||||0.0085|||||||Kruskal-Wallis|||Running: Comparison among age groups was performed using Kruskal-Wallis test.||||0.0085
72415700|NCT00535730|144342163|NON_INFERIORITY_OR_EQUIVALENCE|The power for the noninferiority hypothesis regarding PnPs antibody titer is \~99%. The noninferiority margin is the lower bound of the two-sided 95% confidence interval (CI) on the PnPs antibody GMT ratio \[concomitant/nonconcomitant\] being \>05.|||||<|0.001||95.0||||The threshold for statistical significance is 0.025. There is no adjustment for multiple comparisons.|longitudinal regression model|Week 4 postvac, estimated responses, GMT ratio, 95% CI, p-value based on a longitudinal regression model adjusting for prevac titers and age (years)||The hypothesis was that the GMT of the PnPs antibody responses to serotype 22F at 4 weeks postvaccination in subjects who receive ZOSTAVAX™ concomitantly with PNEUMOVAX™ 23 will be noninferior to those in subjects who receive ZOSTAVAX™ nonconcomitantly.||||<0.001
72415701|NCT00936858|144342164|OTHER||6 month PFS probability|0.35|||||TWO_SIDED|||||||||We will declare the trial a success after observing 7 or more patients with PFS within 6 months. The study will have alpha = 0.092 and power =0.970, assuming a 6 month PFS probability of 0.12 for the null and a PFS probability of 0.35 as the alternative hypothesis.||||
72597260|NCT04165135|144725604|OTHER|||||||0.1098|||||||Kruskal-Wallis|||Swimming: Comparison among age groups was performed using Kruskal-Wallis test.||||0.1098
72597261|NCT04165135|144725604|OTHER|||||||0.2703|||||||Kruskal-Wallis|||Tapis Roulant: Comparison among age groups was performed using Kruskal-Wallis test.||||0.2703
72597262|NCT04165135|144725604|OTHER|||||||0.3366|||||||Kruskal-Wallis|||Gym Weights: Comparison among age groups was performed using Kruskal-Wallis test.||||0.3366
72597263|NCT04165135|144725604|OTHER|||||||0.0992|||||||Kruskal-Wallis|||Exercises at Intervals: Comparison among age groups was performed using Kruskal-Wallis test.||||0.0992
72597264|NCT04165135|144725604|OTHER|||||||0.1194|||||||Kruskal-Wallis|||General: Comparison among age groups was performed using Kruskal-Wallis test.||||0.1194
72597265|NCT04165135|144725604|OTHER|||||||0.0549|||||||Kruskal-Wallis|||Walk: Comparison among age groups was performed using Kruskal-Wallis test.||||0.0549
72597266|NCT04165135|144725605|OTHER|||||||0.0088|||||||Chi-squared|||Comparison among age groups was performed using Chi-squared test.||||0.0088
72597267|NCT01618916|144725667|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-49.92|||<|0.001||90.0|-63.84|-35.99|||Mixed Effects Model Analysis|P-value is for Day 43.||||-35.99|-63.84|<0.001
72597268|NCT01618916|144725667|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-34.85|||<|0.001||90.0|-48.78|-20.93|||Mixed Effects Model Analysis|P-value is for Day 57.||||-20.93|-48.78|<0.001
72597269|NCT01618916|144725667|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-47.72|||<|0.001||90.0|-62.1|-33.34|||Mixed Effects Model Analysis|P-value is for Day 43.||||-33.34|-62.10|<0.001
72415702|NCT05525494|144342177|SUPERIORITY||Adjusted Risk Ratio|0.99|||||TWO_SIDED|95.0|0.98|1.01|||||Adjusted risk ratio. These results compare arms which received portal (any type) reminder/recall messages to the arm receiving no reminder/recall messages (control).|Comparing the risk of receiving an influenza vaccination||1.01|0.98|
72597270|NCT01618916|144725667|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-32.26|||<|0.001||90.0|-46.69|-17.82|||Mixed Effects Model Analysis|P-value is for Day 57.||||-17.82|-46.69|<0.001
72597271|NCT01618916|144725667|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-45.36|||<|0.001||90.0|-60.07|-30.64|||Mixed Effects Model Analysis|P-value is for Day 43.||||-30.64|-60.07|<0.001
72597272|NCT01618916|144725667|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-32.04|||<|0.001||90.0|-46.76|-17.32|||Mixed Effects Model Analysis|P-value is for Day 57.||||-17.32|-46.76|<0.001
72597273|NCT01618916|144725667|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-46.8|||<|0.001||90.0|-61.12|-32.49|||Mixed Effects Model Analysis|P-value is for Day 43.||||-32.49|-61.12|<0.001
72597274|NCT01618916|144725667|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-44.64|||<|0.001||90.0|-58.95|-30.32|||Mixed Effects Model Analysis|P-value is for Day 57.||||-30.32|-58.95|<0.001
72597275|NCT01618916|144725667|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-6.53||||0.44||90.0|-20.51|7.44|||Mixed Effect Model Analysis|P-value is for Day 127||||7.44|-20.51|0.440
72597276|NCT01618916|144725667|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-14.1||||0.108||90.0|-28.53|0.33|||Mixed Effect Model Analysis|P-value is for Day 127.||||0.33|-28.53|0.108
72597277|NCT01618916|144725667|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-22.41||||0.013||90.0|-37.13|-7.69|||Mixed Effect Model Analysis|P-value is for Day 127.||||-7.69|-37.13|0.013
72597278|NCT01618916|144725667|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-17.93||||0.042||90.0|-32.42|-3.44|||Mixed Effect Model Analysis|P-value is for Day 127.||||-3.44|-32.42|0.042
72597279|NCT02867202|144725689|OTHER||||||<|0.05|||||||t-test, 2 sided|||Data analysis was performed with SPSS version 22.0, using two-sided test, and a p value \< 0.05 was considered statistically significant.||||<0.05
72597280|NCT03763058|144725712|SUPERIORITY||Mean Difference (Final Values)|-2.8|STANDARD_DEVIATION|4.19||0.012|TWO_SIDED|95.0|||||Sign test|||||||0.012
72597281|NCT03763058|144725713|SUPERIORITY||Mean Difference (Final Values)|-5.45|STANDARD_DEVIATION|15.52||0.002|TWO_SIDED|95.0|||||Sign test|||||||0.002
72597282|NCT03763058|144725714|SUPERIORITY||Mean Difference (Final Values)|-1.2|STANDARD_DEVIATION|2.71||0.045|TWO_SIDED|95.0|||||Sign test|||||||0.045
72597283|NCT03763058|144725715|SUPERIORITY||Mean Difference (Final Values)|-3.65|STANDARD_DEVIATION|4.59|<|0.001|TWO_SIDED|95.0|||||Sign test|||||||<0.001
72597284|NCT03763058|144725716|SUPERIORITY||Mean Difference (Final Values)|-4.15|STANDARD_DEVIATION|5.1|<|0.001|TWO_SIDED|95.0|||||Sign test|||Total HAD score||||<0.001
72597285|NCT02638051|144725752|SUPERIORITY_OR_OTHER|||||||0.014|||||||Chi-squared|||"Applies to Objective Response Rate (ORR)"||||0.0140
72597286|NCT02638051|144725753|SUPERIORITY_OR_OTHER|||||||0.0016|||||||Chi-squared|||"Applies to All Adverse Events rate"||||0.0016
72415703|NCT05525494|144342177|SUPERIORITY||Adjusted Risk Ratio|1.0|||||TWO_SIDED|95.0|0.98|1.01|||||Adjusted risk ratio. These results compare arms which received text (any type) reminder/recall messages to the arm receiving no reminder/recall messages (control).|Comparing the risk of receiving an influenza vaccination||1.01|0.98|
72597287|NCT02638051|144725753|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Chi-squared|||"Applies to Abdominal pain rate"||||>0.05
72597288|NCT02638051|144725753|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Chi-squared|||"Applies to Gastrointestinal reactions"||||>0.05
72597289|NCT02638051|144725753|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Chi-squared|||"Applies to Damage of hepatic or renal function"||||>0.05
72597290|NCT02638051|144725753|SUPERIORITY_OR_OTHER|||||||0.0215|||||||Chi-squared|||"Applies to Bone marrow depression"||||0.0215
72597291|NCT02638051|144725754|SUPERIORITY_OR_OTHER|||||||0.0053|||||||Chi-squared|||"Applies to Better QoL"||||0.0053
72597292|NCT02638051|144725754|SUPERIORITY_OR_OTHER|||||||0.0527|||||||Chi-squared|||"Applies to No Change"||||0.0527
72597293|NCT02638051|144725754|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Chi-squared|||"Applies to Worse QoL"||||>0.05
72597294|NCT01625689|144725792|SUPERIORITY_OR_OTHER||||||>=|0.498|TWO_SIDED|||||No comparison between the LAIV and placebo groups by type of solicited reaction had a p-value below 0.498.|Fisher Exact|||||||>=0.498
72597295|NCT02134353|144725800|SUPERIORITY||Mean Difference (Net)|54.0||||0.02|TWO_SIDED|95.0|8.0|100.0|||Mixed Models Analysis||Missing data for withdrawals related to safety or efficacy imputed using BOCF (baseline observation carried forward). Data collected at 6, 14 and 26 weeks.|||100|8|0.020
72597296|NCT02134353|144725801|SUPERIORITY||Mean Difference (Net)|40.0||||0.128|TWO_SIDED|95.0|-12.0|92.0||Missing data for withdrawals due to safety/efficacy imputed using BOCF. Data collected at 6,14 and 26 weeks.|Mixed Models Analysis||Missing data for withdrawals related to safety or efficacy imputed using BOCF. Data collected at 6, 14 and 26 weeks.|||92|-12|0.128
72597297|NCT02134353|144725802|SUPERIORITY||Cox Proportional Hazard|1.14||||0.629|TWO_SIDED|95.0|0.671|1.936|||Regression, Cox|||||1.936|0.671|0.629
72415704|NCT05525494|144342177|SUPERIORITY||Adjusted Risk Ratio|1.01|||||TWO_SIDED|95.0|1.0|1.02|||||Adjusted risk ratio. These results compare arms which received pre-appointment reminder/recall messages (portal and text) to the arm receiving no reminder/recall messages (control).|Comparing the risk of receiving an influenza vaccination||1.02|1.00|
72597298|NCT02134353|144725803|SUPERIORITY||Rate ratio|0.75||||0.673|TWO_SIDED|95.0|0.198|2.846|||Negative binomial model|||||2.846|0.198|0.673
72597299|NCT02134353|144725804|SUPERIORITY||Rate ratio|1.273||||0.735|TWO_SIDED|95.0|0.315|5.154|||Negative binomial model|||||5.154|0.315|0.735
72597300|NCT02134353|144725805|SUPERIORITY||Rate ratio|1.545||||0.055|TWO_SIDED|95.0|0.99|2.411|||Negative binomial model|||Patients withdrawing early without an exacerbation had rate imputed based on number of exacerbations in 12 months prior to screening.||2.411|0.990|0.055
72597301|NCT02134353|144725805|SUPERIORITY||Rate ratio|1.357||||0.246|TWO_SIDED|95.0|0.81|2.275|||Negative binomial model|||Sensitivity analysis with no imputation of missing data.||2.275|0.810|0.246
72597302|NCT02134353|144725806|SUPERIORITY||Odds Ratio (OR)|1.009||||0.976|TWO_SIDED|95.0|0.555|1.836|||Regression, Logistic|||||1.836|0.555|0.976
72597303|NCT02134353|144725807|SUPERIORITY||Mean Difference (Net)|0.259||||0.083|TWO_SIDED|95.0|-0.034|0.551|||Mixed Models Analysis|Missing values due to withdrawal related to safety/efficacy imputed using BOCF||||0.551|-0.034|0.083
72597304|NCT02134353|144725808|SUPERIORITY||Mean Difference (Net)|0.87||||0.453|TWO_SIDED|95.0|-1.406|3.145|||Mixed Models Analysis||Missing values due to withdrawal related to safety/efficacy imputed using BOCF|||3.145|-1.406|0.453
72597305|NCT02134353|144725809|SUPERIORITY||Mean Difference (Net)|87.0||||0.012|TWO_SIDED|95.0|20.0|155.0|||Mixed Models Analysis||Missing data due to withdrawals for reasons related to safety/efficacy imputed using BOCF|||155|20|0.012
72597306|NCT00477607|144725810|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.0||||0.89|TWO_SIDED|95.0|0.4|11.4|||Fisher Exact|No adjustments. Right one-sided p-value.||H0: pr(Hearing loss arm 1) = pr(Hearing loss arm 2)||11.4|0.4|0.89
72597307|NCT00477607|144725811|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.195|STANDARD_ERROR_OF_MEAN|0.3999||0.63|TWO_SIDED|95.0|-1.03|0.64|||t-test, 2 sided|||H0: mean (MDA arm 1) = mean (MDA Arm 2)||0.64|-1.03|0.63
72597308|NCT00477607|144725812|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|48.2|STANDARD_ERROR_OF_MEAN|32.7||0.15|TWO_SIDED|95.0|-18.1|114.6|||t-test, 2 sided|||H0: mean(max dose arm 1) = mean(max dose arm 2)||114.6|-18.1|0.15
72597309|NCT03403621|144725880|SUPERIORITY|||||||0.42|||||||t-test, 2 sided|||Baseline versus 2 weeks||||0.42
72597310|NCT03403621|144725880|SUPERIORITY|||||||0.72|||||||t-test, 2 sided|||Baseline versus 4 weeks||||0.72
72597311|NCT03403621|144725880|SUPERIORITY|||||||0.51|||||||t-test, 2 sided|||Baseline versus 2 weeks||||0.51
72597312|NCT03403621|144725880|SUPERIORITY|||||||0.58|||||||t-test, 2 sided|||Baseline versus 4 weeks||||0.58
72597313|NCT03403621|144725881|SUPERIORITY|||||||0.03|||||||t-test, 2 sided|||Baseline versus 2 weeks||||0.03
72597314|NCT03403621|144725881|SUPERIORITY|||||||0.08|||||||t-test, 2 sided|||Baseline versus 4 weeks||||0.08
72597315|NCT03403621|144725881|SUPERIORITY|||||||0.02|||||||t-test, 2 sided|||Baseline versus 2 weeks||||0.02
72597316|NCT03403621|144725881|SUPERIORITY|||||||0.007|||||||t-test, 2 sided|||Baseline versus 4 weeks||||0.007
72597317|NCT03403621|144725882|SUPERIORITY|||||||0.21|||||||t-test, 2 sided|||Baseline versus 2 weeks||||0.21
72597318|NCT03403621|144725882|SUPERIORITY|||||||0.18|||||||t-test, 2 sided|||Baseline versus 4 weeks||||0.18
72597319|NCT03403621|144725882|SUPERIORITY|||||||0.33|||||||t-test, 2 sided|||Baseline versus 2 weeks||||0.33
72597320|NCT03403621|144725882|SUPERIORITY|||||||0.5|||||||t-test, 2 sided|||Baseline versus 4 weeks||||0.5
72597321|NCT01093651|144725884|SUPERIORITY_OR_OTHER||||||>|0.05||95.0||||The a priori threshold for statistical significance was p\<0.05. The main effect analysis for CD4+ T-cell count over time and between the 2 groups did not achieve p\<0.05 (not statistically significant).|Mixed Models Analysis|Study subject was included in these models as a random variable to account for within-participant correlation.||The main effect analysis was applied to both rows (timepoint) and categories (groups). It used linear mixed models to simultaneously assess differences in CD4+ T-cell count between the DPP4 inhibitor and placebo groups (categories) over time (rows). Pairwise post-hoc contrasts were performed to assess the between and within group differences in outcome measures at each time point.||||>0.05
72597322|NCT01093651|144725885|SUPERIORITY_OR_OTHER||||||>|0.05||95.0||||The a priori threshold for statistical significance was p\<0.05. The main effect analysis for plasma HIV RNA copy number/mL over time and between the 2 groups did not achieve p\<0.05 (not statistically significant).|Mixed Models Analysis|||The main effect analysis was applied to both rows (timepoint) and categories (groups). It used linear mixed models to simultaneously assess differences in plasma HIV RNA copy number/mL between the DPP4 inhibitor and placebo groups (categories) over time (rows). Pairwise post-hoc contrasts were performed to assess the between and within group differences in outcome measures at each time point.||||>0.05
72597323|NCT01093651|144725886|SUPERIORITY_OR_OTHER||||||>|0.05||95.0||||The a priori threshold for statistical significance was p\<0.05. The main effect analysis for serum TNFR2 levels over time and between the 2 groups did not achieve p\<0.05 (not statistically significant).|Mixed Models Analysis|||The main effect analysis was applied to both rows (timepoint) and categories (groups). It used linear mixed models to simultaneously assess differences in serum TNFR2 levels between the DPP4 inhibitor and placebo groups (categories) over time (rows). Pairwise post-hoc contrasts were performed to assess the between and within group differences in outcome measures at each time point.||||>0.05
72597324|NCT01093651|144725887|SUPERIORITY_OR_OTHER||||||<|0.0002||95.0||||The a priori threshold for statistical significance was p\<0.05. The main effect analysis for SDF1-alpha levels over time and between the 2 groups achieved p\<0.0002.|Mixed Models Analysis|||The main effect analysis was applied to both rows (timepoint) and categories (groups). It used linear mixed models to simultaneously assess differences in serum SDF1α levels between the DPP4 inhibitor and placebo groups (categories) over time (rows). Pairwise post-hoc contrasts were performed to assess the between and within group differences in outcome measures at each time point.||||<0.0002
72597325|NCT01093651|144725888|SUPERIORITY_OR_OTHER||||||>|0.05||95.0||||The a priori threshold for statistical significance was p\<0.05. The main effect analysis for serum RANTES levels over time and between the 2 groups did not achieve p\<0.05 (not statistically significant).|Mixed Models Analysis|||The main effect analysis was applied to both rows (timepoint) and categories (groups). It used linear mixed models to simultaneously assess differences in serum RANTES levels between the DPP4 inhibitor and placebo groups (categories) over time (rows). Pairwise post-hoc contrasts were performed to assess the between and within group differences in outcome measures at each time point.||||>0.05
72597326|NCT01093651|144725889|SUPERIORITY_OR_OTHER||||||<|0.04||95.0||||The a priori threshold for statistical significance was p\<0.05. The main effect analysis for area under the glucose tolerance curve over time and between the 2 groups achieved p\<0.04.|Mixed Models Analysis|||The main effect analysis was applied to both rows (timepoint) and categories (groups). It used linear mixed models to simultaneously assess differences in area under the glucose tolerance curves between the DPP4 inhibitor and placebo groups (categories) over time (rows). Pairwise post-hoc contrasts were performed to assess the between and within group differences in outcome measures at each time point.||||<0.04
72597327|NCT01093651|144725890|SUPERIORITY_OR_OTHER||||||>|0.05||95.0||||The a priori threshold for statistical significance was p\<0.05. The non-paramteric test for adverse event cummulative frequency between the 2 groups did not achieve p\<0.05 (not statistically significant)|Kruskal-Wallis|||Kruskal-Wallis non-parametric test of cell frequencies||||>0.05
72597328|NCT03611582|144725891|SUPERIORITY||Treatment difference|-10.27|||<|0.0001|TWO_SIDED|95.0|-11.97|-8.57|||ANCOVA|||Treatment policy estimand||-8.57|-11.97|<.0001
72597329|NCT03611582|144725891|SUPERIORITY||Treatment difference|-12.67|||<|0.0001|TWO_SIDED|95.0|-14.34|-11.0|||MMRM (mixed model repeated measurement)|||Hypothetical estimand||-11.00|-14.34|<0.0001
72597330|NCT03611582|144725892|SUPERIORITY||Odds Ratio (OR)|6.11|||<|0.0001|TWO_SIDED|95.0|4.04|9.26|||Regression, Logistic|||Treatment policy estimand||9.26|4.04|<0.0001
72597331|NCT03611582|144725892|SUPERIORITY||Odds Ratio (OR)|11.67|||<|0.0001|TWO_SIDED|95.0|7.64|17.81|||MMRM (mixed model repeated measurement)|||Hypothetical estimand||17.81|7.64|<0.0001
72597332|NCT04459598|144725922|OTHER|Least squares (LS) means were calculated from an analysis of variance (ANOVA) model on log-transformed scale. The LS means for each treatment were back transformed from the log scale to provide estimates of the geometric means (GMS). The ratio (%) of GMS was calculated and 90% Confidence Intervals (CIs) for the ratio (%) of GMS were presented.|Ratio (%) of Geometric LS Mean|55.24|||||TWO_SIDED|90.0|45.24|67.46|||||For the comparison, the Efavirenz + Quizartinib treatment group represents the numerator and Quizartinib only treatment group represents the denominator.|Statistical comparison was analyzed for Quizartinib.||67.46|45.24|
72597333|NCT04459598|144725922|OTHER|Least squares (LS) means were calculated from an analysis of variance (ANOVA) model on log-transformed scale. The LS means for each treatment were back transformed from the log scale to provide estimates of the geometric means (GMS). The ratio (%) of GMS was calculated and 90% Confidence Intervals (CIs) for the ratio (%) of GMS were presented.|Ratio (%) of Geometric LS Mean|32.37|||||TWO_SIDED|90.0|23.79|44.05|||||For the comparison, the Efavirenz + Quizartinib treatment group represents the numerator and Quizartinib only treatment group represents the denominator.|Statistical comparison was analyzed for AC886.||44.05|23.79|
72415705|NCT05525494|144342177|SUPERIORITY||Adjusted Risk Ratio|1.0|||||TWO_SIDED|95.0|0.99|1.01|||||Adjusted risk ratio. These results compare arms which received a tailored reminder/recall messages based on their responses to a pre-commitment questionnaire (any type) to the arm receiving no reminder/recall messages (control).|Comparing the risk of receiving an influenza vaccination||1.01|0.99|
72415706|NCT00762320|144342183|SUPERIORITY_OR_OTHER||||||=|0.004|||||||t-test, 2 sided|df=4||||||=.004
72415707|NCT00762320|144342188|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|df=7||||||<.001
72597334|NCT04459598|144725924|OTHER|Least squares (LS) means were calculated from an analysis of variance (ANOVA) model on log-transformed scale. The LS means for each treatment were back transformed from the log scale to provide estimates of the geometric means (GMS). The ratio (%) of GMS was calculated and 90% Confidence Intervals (CIs) for the ratio (%) of GMS were presented.|Ratio (%) of Geometric LS Mean|11.11|||||TWO_SIDED|90.0|8.47|14.56|||||For the comparison, the Efavirenz + Quizartinib treatment group represents the numerator and Quizartinib only treatment group represents the denominator.|Statistical comparison was analyzed for Quizartinib.||14.56|8.47|
72597335|NCT04459598|144725924|OTHER|Least squares (LS) means were calculated from an analysis of variance (ANOVA) model on log-transformed scale. The LS means for each treatment were back transformed from the log scale to provide estimates of the geometric means (GMS). The ratio (%) of GMS was calculated and 90% Confidence Intervals (CIs) for the ratio (%) of GMS were presented.|Ratio (%) of Geometric LS Mean|3.67|||||TWO_SIDED|90.0|2.47|5.45|||||For the comparison, the Efavirenz + Quizartinib treatment group represents the numerator and Quizartinib only treatment group represents the denominator.|Statistical comparison was analyzed for AC886.||5.45|2.47|
72415708|NCT00417079|144342273|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||A 2-sided significance level of 0.0452 was used for the final analysis based on an interim analysis performed after 307 events with an adjusted significance level of 0.016 based on the O'Brien-Fleming type 1 error spending function.|Log Rank|Analysis was performed by using a log-rank comparisons stratified according to disease measurability and ECOG performance status (0-1 versus 2)||The study required an estimated sample size of 720 patients (360 per arm) in order to detect a 25% reduction in the hazard ratio for death in the cabazitaxel group relative to the mitoxantrone group with 90% power. The final analysis was planned for when 511 deaths had occurred.||||<0.0001
72415709|NCT00417079|144342274|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Log Rank|||||||<0.0001
72415710|NCT00417079|144342275|SUPERIORITY_OR_OTHER|||||||0.0005||95.0|||||Chi-squared|||||||0.0005
72597336|NCT04459598|144725925|OTHER|Least squares (LS) means were calculated from an analysis of variance (ANOVA) model on log-transformed scale. The LS means for each treatment were back transformed from the log scale to provide estimates of the geometric means (GMS). The ratio (%) of GMS was calculated and 90% Confidence Intervals (CIs) for the ratio (%) of GMS were presented.|Ratio (%) of Geometric LS Mean|10.29|||||TWO_SIDED|90.0|7.73|13.7|||||For the comparison, the Efavirenz + Quizartinib treatment group represents the numerator and Quizartinib only treatment group represents the denominator.|Statistical comparison was analyzed for Quizartinib.||13.70|7.73|
72597337|NCT04459598|144725925|OTHER|Least squares (LS) means were calculated from an analysis of variance (ANOVA) model on log-transformed scale. The LS means for each treatment were back transformed from the log scale to provide estimates of the geometric means (GMS). The ratio (%) of GMS was calculated and 90% Confidence Intervals (CIs) for the ratio (%) of GMS were presented.|Ratio (%) of Geometric LS Mean|3.88|||||TWO_SIDED|90.0|2.62|5.76|||||For the comparison, the Efavirenz + Quizartinib treatment group represents the numerator and Quizartinib only treatment group represents the denominator.|Statistical comparison was analyzed for AC886.||5.76|2.62|
72597338|NCT01078298|144725931|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.35|||<|0.0001|TWO_SIDED|95.0|2.16|5.21|||Regression, Logistic|||Odds Ratios and p-values were obtained from a logistic regression model including the main effects of treatment, pooled center and cohort.||5.21|2.16|<0.0001
72597339|NCT01078298|144725932|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.53||||0.0001|TWO_SIDED|95.0|1.56|4.1|||Regression, Logistic|||For Week 9 through 24, odds ratio and p-value were calculated from logistic regression model including the main effects of treatment, pooled center and cohort.||4.10|1.56|0.0001
72415711|NCT00417079|144342276|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.61|||<|0.0001|TWO_SIDED|95.0|0.49|0.76|||Log Rank|Log-rank comparisons stratified according to disease measurability and ECOG performance status.|Hazard ratio (HR) \< 1 favours the cabazitaxel group and \> 1 favours the mitoxantrone group.|||0.76|0.49|<0.0001
72415712|NCT00417079|144342277|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.75||||0.001|TWO_SIDED|95.0|0.63|0.9|||Log Rank|Log-rank comparisons stratified according to disease measurability and ECOG performance status.|Hazard ratio (HR) \< 1 favours the cabazitaxel group and \> 1 favours the mitoxantrone group.|||0.90|0.63|0.0010
72415713|NCT00417079|144342278|SUPERIORITY_OR_OTHER|||||||0.0002||95.0|||||Chi-squared|||||||0.0002
72415714|NCT00417079|144342279|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.91||||0.5192|TWO_SIDED|95.0|0.69|1.19|||Log Rank|Log-rank comparisons stratified according to disease measurability and ECOG performance status.|Hazard ratio (HR) \< 1 favours the cabazitaxel group and \> 1 favours the mitoxantrone group.|||1.19|0.69|0.5192
72415715|NCT00417079|144342280|SUPERIORITY_OR_OTHER|||||||0.6286||95.0|||||Chi-squared|||||||0.6286
72597340|NCT01078298|144725932|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.36||||0.0011|TWO_SIDED|95.0|1.4|3.98|||Regression, Logistic|||For Week 9 through 52, odds ratio and p-value were calculated from logistic regression model including the main effects of treatment, pooled center and cohort.||3.98|1.40|0.0011
72597341|NCT01078298|144725933|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.82|||<|0.0001|TWO_SIDED|95.0|2.53|5.78|||Regression, Logistic|||For Week 12, odds ratio and p-values were obtained from a logistic regression model including the main effects of treatment, pooled center and cohort.||5.78|2.53|<0.0001
72597342|NCT01078298|144725933|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.16||||0.0004|TWO_SIDED|95.0|1.4|3.33|||Regression, Logistic|||For Week 24, odds ratio and p-values were obtained from a logistic regression model including the main effects of treatment, pooled center and cohort.||3.33|1.40|0.0004
72597343|NCT01078298|144725933|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.98||||0.002|TWO_SIDED|95.0|1.28|3.08|||Regression, Logistic|||For Week 52, odds ratio and p-values were obtained from a logistic regression model including the main effects of treatment, pooled center and cohort.||3.08|1.28|0.0020
72597344|NCT01078298|144725934|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.97||||0.0027|TWO_SIDED|95.0|1.26|3.08|||Regression, Logistic|||Odds Ratios and p-values were obtained from a logistic regression model including the main effects of treatment, pooled center and cohort.||3.08|1.26|0.0027
72415716|NCT04403698|144342283|SUPERIORITY||||||<|0.01|||||||Mixed Models Analysis|||linear mixed models were used to compare bone turnover markers (CTX-I) between both treatment groups. These models were performed with an intention to treat approach, where drop-outs were considered as non-responders. The models accounted for repeated measures.||||<0.01
72597345|NCT00564278|144725958|SUPERIORITY_OR_OTHER_LEGACY||GEE model Beta|17.46||||0.26|TWO_SIDED|95.0|-16.61|51.53||All analyses presented are at 9 months.|t-test, 2 sided|t(193) = -1.14, p=.26||"We also conducted an analysis using a Generalized Estimating Equations model adjusting for a number of covariates.~We will conduct a three-part regression analysis assessing early/middle/late effects of MPT on retention. We will also conduct moderator analyses, as described in the original study grant, to determine whether there are specific patient groups for whom a significant difference in days in treatment is found."||51.53|-16.61|0.26
72597346|NCT00564278|144725959|SUPERIORITY_OR_OTHER_LEGACY||Mixed Model Beta for MADT vs SADT|-0.28|||||TWO_SIDED|95.0|-1.57|1.01||See Method of Estimation below.|||A Generalized Linear Mixed Model was used with random intercept for clinician adjusted for baseline depressive symptoms and time to assess the effect of MADT vs. SADT on mean depressive symptoms over follow-up.|||1.01|-1.57|
72597347|NCT00564278|144725960|SUPERIORITY_OR_OTHER_LEGACY||Work - Mixed Model Beta for MADT vs SADT|0.22|||||TWO_SIDED|95.0|-0.5|0.95||See under Method of Estimation, below|||A Generalized Linear Mixed Model was used with random intercept for clinician adjusted for baseline work-related disability score and time to assess the effect of MADT vs. SADT on mean disability score in the work domain over follow-up.|||0.95|-0.50|
72597348|NCT00564278|144725960|SUPERIORITY_OR_OTHER_LEGACY||Social-Mixed Model Beta for MADT vs SADT|0.22|||||TWO_SIDED|95.0|-0.49|0.92||See under Method of Estimation below.|||A Generalized Linear Mixed Model was used with random intercept for clinician adjusted for baseline social-related disability score and time to assess the effect of MADT vs. SADT on mean disability score in the social domain over follow-up.|||0.92|-0.49|
72597349|NCT00564278|144725960|SUPERIORITY_OR_OTHER_LEGACY||Family-Mixed Model Beta for MADT vs SADT|0.55|||||TWO_SIDED|95.0|-0.08|1.18||See Method of Estimation below.|||A Generalized Linear Mixed Model was used with random intercept for clinician adjusted for baseline family-related disability score and time to assess the effect of MADT vs. SADT on mean disability score in the family domain over follow-up.|||1.18|-0.08|
72597350|NCT00564278|144725961|SUPERIORITY_OR_OTHER_LEGACY||Mixed Model Beta for MADT vs SADT|0.02|||||TWO_SIDED|95.0|-3.61|3.64||See Method of Estimation, below|||A Generalized Linear Mixed Model was used with random intercept for clinician adjusted for baseline QOL score and time to assess the effect of MADT vs. SADT on mean percent of quality of life over follow-up.|||3.64|-3.61|
72597351|NCT00564278|144725962|SUPERIORITY_OR_OTHER_LEGACY||Mixed Model Beta for MADT vs SADT|-0.04|||||TWO_SIDED|95.0|-0.74|0.66||See Method of Estimation below.|||A Generalized Linear Mixed Model was used with random intercept for clinician adjusted for baseline patient satisfaction and time to assess the effect of MADT vs. SADT on mean patient satisfaction over follow-up.|||0.66|-0.74|
72597352|NCT00564278|144725963|SUPERIORITY_OR_OTHER_LEGACY||Mixed Model Beta for MADT vs SADT|9.14|||||TWO_SIDED|95.0|2.71|15.57||See Method of Estimation below.|||A Generalized Linear Mixed Model was used with random intercept for clinician to model the effect of MPT vs. SADT on the mean proportion of fully adherent days over the study period. We used an exchangeable covariance structure.|||15.57|2.71|
72597353|NCT02368886|144725970|SUPERIORITY||Risk Difference (RD)|0.17||||0.0434|TWO_SIDED|95.0|0.0|0.34||1-sided|Fisher Exact|||||0.34|0.00|0.0434
72597354|NCT02368886|144725971|SUPERIORITY||Hazard Ratio (HR)|0.72||||0.1241|TWO_SIDED|95.0|0.47|1.1|||Log Rank|||||1.10|0.47|0.1241
72597355|NCT02368886|144725972|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.3797|TWO_SIDED|95.0|0.57|1.24|||Log Rank|||||1.24|0.57|0.3797
72597356|NCT02368886|144725973|SUPERIORITY||Hazard Ratio (HR)|0.85||||0.4614|TWO_SIDED|95.0|0.55|1.31|||Log Rank|||||1.31|0.55|0.4614
72597357|NCT02368886|144725978|SUPERIORITY|||||||0.7319|||||||Kruskal-Wallis|||||||0.7319
72597358|NCT02173379|144725983|NON_INFERIORITY|One-sided p-value by using Farrington-Manning non-inferiority test statistic with non-inferiority margin of 2.9%, to be compared with a one-sided significance level of 0.025.||||||0.0244|ONE_SIDED|97.5|||||Farrington-Manning|||"The hypothesis test is designed to show non-inferiority of Absorb BVS to XIENCE for the primary endpoint with a one-sided alpha of 0.025. The null (H0) and alternative (HA) hypotheses are:~H0: TLFAbsorb - TLFXIENCE ≥ ∆TLF HA: TLFAbsorb - TLFXIENCE \< ∆TLF."||||0.0244
72597359|NCT02173379|144725984|NON_INFERIORITY|One-sided p-value by using Farrington-Manning non-inferiority test statistic with non-inferiority margin of 4.8%, to be compared with a one-sided significance level of 0.025.||||||0.0006|||||||Farrington-Manning|||||||0.0006
72597360|NCT04997265|144726154|OTHER|Given the small sample size, simple descriptive were used. Between-group differences were performed using a Fisher exact test.|||||<|0.05|||||||Fisher Exact|||||||<0.05
72597361|NCT04942210|144726176|NON_INFERIORITY|The non-inferiority was demonstrated if the lower limit of the 2-sided 95% confidence interval (CI) was \>-5%|Difference in percentage of participants|0.3|||||TWO_SIDED|95.0|-1.2|3.2|||||95% CI of the difference was calculated from the Wilson score method without continuity correction.|||3.2|-1.2|
72597362|NCT02776670|144726223|NON_INFERIORITY|Noninferiority was deemed established if the lower limit of the 95% CI (equivalent to the 1-sided 97.5% CI) for the adjusted estimate of the difference (Systane Balance-Refresh Optive Advanced/Optive Plus) was above the noninferiority margin of -1.0 second.|Mean Difference (Final Values)|0.13|||<|0.0001|TWO_SIDED|95.0|-0.341|0.601||p-value for testing noninferiority of Systane Balance with respect to Refresh Optive Advanced/Refresh Optive Plus is calculated for predefined noninferiority margin of -1.0 second.|Mixed model repeated measures (MMRM)|||||0.601|-0.341|<0.0001
72597363|NCT02776670|144726224|SUPERIORITY||Mean Difference (Final Values)|0.118||||0.31|TWO_SIDED|95.0|-0.349|0.585|||MMRM|||||0.585|-0.349|0.310
72597364|NCT02776670|144726226|SUPERIORITY||Mean Difference (Final Values)|-0.8||||0.618|TWO_SIDED|95.0|-6.4|4.7|||MMRM|||||4.7|-6.4|0.618
72415717|NCT04403698|144342284|SUPERIORITY|||||||0.05|||||||Mixed Models Analysis|||linear mixed models were used to compare bone turnover markers (PINP) between both treatment groups. These models were performed with an intention to treat approach, where drop-outs were considered as non-responders. The models accounted for repeated measures.||||0.05
72415718|NCT04403698|144342285|SUPERIORITY|||||||0.042|||||||Fisher Exact|||A Fisher's exact test was used to assess differences in patient numbers exceeding reference ranges between both treatment groups at week 48||||0.042
72415719|NCT04403698|144342286|SUPERIORITY|||||||0.042|||||||Fisher Exact|||A Fisher's exact test was used to assess differences in patient numbers exceeding reference ranges between both treatment groups.||||0.042
72597365|NCT04000360|144726253|SUPERIORITY||Difference in slopes.|-3.62|STANDARD_ERROR_OF_MEAN|0.91|<|0.0001|TWO_SIDED|95.0|-5.4|-1.85||This was the sole primary outcome. The test was conducted with a priori p-value threshold of α=0.05, with no multiple comparison adjustment.|Mixed Models Analysis|Test of equality of slopes with time (change in points/year) between aerobic exercise (AE) and usual and customary care (UCC) treatment arms.|Higher MDS-UPDRS III score reflects worse Parkinson's symptoms; increases reflect PD progression. The reported effect is the estimated difference between annual rates of change in scores of AE and UCC patients.|Linear mixed model for baseline, 6 month, and 12 month data, with fixed effects of clinical site, treatment, and linear time nested in treatment arm, and AR(1) covariance structure, fit by residual pseudolikelihood maximization (RSPL) in SAS PROC GLIMMIX.||-1.85|-5.40|<0.0001
72415720|NCT00567242|144342315|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2801|STANDARD_ERROR_OF_MEAN|0.1077|<|0.05|ONE_SIDED|95.0||-0.0709|||t-test, 1 sided|||"H1: The Intention Group will show a significant rightward shift in lateral frontal laterality from pre-treatment to post-treatment.~H0: The Intention Group will show no shift in lateral frontal laterality from pre-treatment to post-treatment.~Since this is a repeated measures t test, the data are presented as the mean and standard deviation for for the post-treatment laterality index minus the pre-treatment laterality index."||-0.0709||<.05
72415721|NCT00567242|144342315|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1832|STANDARD_ERROR_OF_MEAN|0.2768|<|0.05|ONE_SIDED|95.0||0.3546|||t-test, 1 sided|||"H1: The Control Group will show a significant rightward shift in lateral frontal lateral indices from pre-treatment to post-treatment.~H0: The Control group will show no shift in lateral frontal laterality indices from pre-treatment to post-treatment.~Since the analysis to test these hypotheses is a repeated-measures t-test, the mean and standard deviation are given for post-treatment laterality index minus pre-treatment laterality index."||0.3546||<.05
72597366|NCT04000360|144726254|SUPERIORITY|Equality of annual slopes in squared 10 Meter Walk Test Comfortable Pace Velocity for the AE and UCC groups.|Difference in squared velocity slopes|12.07|STANDARD_ERROR_OF_MEAN|4.65||0.043|TWO_SIDED|95.0|3.1|21.32||Family-wise error controlled at α=0.05 by Holm-Bonferroni adjustment for other motor domain secondary outcomes: 10 Meter Walk Test fast pace velocity, TUG duration \& turning velocity, Manual Dexterity Test.|Mixed Models Analysis||The reported effect is the difference in annual slope of meters\^2/second, in 100ths of meters\^2/second/year. The confidence interval is not multiple comparison adjusted. Parkinson's progression limits mobility; higher slope reflects less progression.|Linear mixed model for baseline, 6 month, and 12 month data, with fixed effects of clinical site, treatment, and linear time nested in treatment arm, and compound symmetry covariance structure, fit by residual pseudolikelihood maximization (RSPL) in SAS PROC GLIMMIX. To reduce skew and better meet modeling assumptions, test velocity was squared ((meters/second)\^2) for modeling. Study sample size was based on the primary outcome, and power was not calculated for this and other outcomes.||21.32|3.10|0.043
72597367|NCT04000360|144726255|SUPERIORITY|Equality of annual slopes in 10 Meter Walk Test Fast Pace Velocity for the AE and UCC groups.|Difference in slopes|3.16|STANDARD_ERROR_OF_MEAN|2.68||0.48|TWO_SIDED|95.0|-2.1|8.42||Family-wise error controlled at α=0.05 by Holm-Bonferroni adjustment for other motor domain secondary outcomes: 10 meter walk test comfortable pace, Timed Up and Go Test duration and turning velocity, Manual Dexterity Test.|Mixed Models Analysis||The reported effect is the difference in annual slopes of the AE and UCC treatment arms, in 100ths of meters/second/year. The confidence interval is not multiple comparison adjusted. Higher slope reflects less Parkinson's disease progression.|Linear mixed model for baseline, 6 month, and 12 month data, with fixed effects of clinical site, treatment, and linear time nested in treatment arm, and heterogeneous compound symmetry covariance structure, fit by residual pseudolikelihood maximization (RSPL) in SAS PROC GLIMMIX.||8.42|-2.10|0.48
72597368|NCT04000360|144726256|SUPERIORITY|Equality of annual slopes of inverse Timed Up and Go Test duration, i.e., of TUG completions/second, the speed of completing the test.|Difference in slopes|4.04|STANDARD_ERROR_OF_MEAN|1.96||0.16|TWO_SIDED|95.0|0.2|7.89||Family-wise error controlled at α=0.05 by Holm-Bonferroni adjustment for other motor domain secondary outcomes: 10 meter walk test comfortable \& fast pace, Timed Up and Go Test turning velocity, and Manual Dexterity Test.|Mixed Models Analysis|Difference between estimated annual slopes in TUG completions/second/year for the AE and UCC groups.|Timed Up and Go test speed is expected to decline with Parkinson's progression. The reported effect is the difference between estimated annual slopes for the AE and UCC groups in 1000ths of a TUG completion/second/year.|Linear mixed model for baseline, 6 month, and 12 month data, with fixed effects of clinical site, treatment, and linear time nested in treatment arm, and compound symmetry covariance structure, fit by residual pseudolikelihood maximization (RSPL) in SAS PROC GLIMMIX. To reduce skew and better meet modeling assumptions, test duration was inverted to TUG completions/second. Sample size was based on the primary outcome, and power was not calculated for this and other outcomes.||7.89|0.20|0.16
72597369|NCT04000360|144726257|SUPERIORITY|Test of equality of average turning velocities.|Difference in slopes.|1.85|STANDARD_ERROR_OF_MEAN|1.54||0.69|TWO_SIDED|95.0|-1.17|4.88||Family-wise error controlled at α=0.05 by Holm-Bonferroni adjustment for other motor domain secondary outcomes: 10 meter walk test comfortable \& fast pace, Timed Up and Go Test duration, and Manual Dexterity Test.|Mixed Models Analysis||Timed Up and Go test speed is expected to decline with Parkinson's progression. The reported effect is the difference between estimated annual slopes of average turning velocity for the AE and UCC groups in degrees/second/year.|Linear mixed model for baseline, 6 month, and 12 month data, with fixed effects of clinical site, treatment, and linear time nested in treatment arm, and compound symmetry covariance structure, fit by residual pseudolikelihood maximization (RSPL) in SAS PROC GLIMMIX. Study sample size was based on the primary outcome, and power was not calculated for this and other outcomes.||4.88|-1.17|0.69
72597370|NCT04000360|144726258|SUPERIORITY|Test of equality of slopes of test performance speed (peg transfers/second/year) for AE and UCC groups.|Difference in slopes.|-3.62|STANDARD_ERROR_OF_MEAN|10.23||0.72|TWO_SIDED|95.0|-23.68|16.45||Family-wise error controlled at α=0.05 by Holm-Bonferroni adjustment for other motor domain secondary outcomes: Timed Up and Go Test (TUG) duration \& turning velocity and 10 meter walk test comfortable \& fast pace.|Mixed Models Analysis||Manual dexterity expressed as peg transfers/second is expected to decline with Parkinson's progression. The reported effect is the difference between estimated annual slopes for the AE and UCC groups in 1000ths of a peg transfer/second/year.|Linear mixed model for baseline, 6 and 12 month data, with fixed effects of clinical site, treatment, and linear time nested in treatment arm, and compound symmetry covariance structure, fit by residual pseudolikelihood maximization (RSPL) in SAS PROC GLIMMIX. To reduce skew and better meet modeling assumptions, test duration was transformed for modeling to peg transfers/second (18/seconds). Sample size was based on the primary outcome, and power was not calculated for this and other outcomes.||16.45|-23.68|0.72
72415722|NCT00567242|144342316|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.24|STANDARD_ERROR_OF_MEAN|0.88|<|0.05|ONE_SIDED|95.0|-1.81||||t-test, 1 sided|||"H1: The Intention Group would show more improvement across treatment than the Control Group.~H0: The Intention Group and the Control Group would not show any difference in improvement across treatment."|||-1.81|<.05
72415723|NCT00567242|144342317|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.56|STANDARD_ERROR_OF_MEAN|0.73|<|0.05|ONE_SIDED|95.0|0.26||||t-test, 1 sided|||"H1: The Intention Group would show more improvement across treatment than the Control Group.~H0: The Intention Group and the Control Group would not show any difference in improvement across treatment."|||0.26|<.05
72597371|NCT04000360|144726259|SUPERIORITY|Test of equality of slopes of squared match scores (matches\^2/year) between AE and UCC groups.|Difference in slopes.|-96.91|STANDARD_ERROR_OF_MEAN|69.12||0.48|TWO_SIDED|95.0|-232.41|38.6||Family-wise error controlled at α=0.05 by Holm-Bonferroni adjustment for other non-motor domain secondary outcomes: Visual Memory Test and Trail Making Test B to A duration ratio.|Mixed Models Analysis||Processing speed is expected to decline with Parkinson's, hence duration of the test to increase. The reported effect is the difference in annual slopes (matches\^2/year) between the AE and UCC treatment arms.|Linear mixed model for baseline, 6 month, and 12 month data, with fixed effects of clinical site, treatment, and linear time nested in treatment arm, and heterogeneous compound symmetry covariance structure, fit by residual pseudolikelihood maximization (RSPL) in SAS PROC GLIMMIX. To reduce skew and better meet modeling assumptions, test duration was squared (matches\^2) for analysis. Study sample size was based on the primary outcome, and power was not calculated for this and other outcomes.||38.60|-232.41|0.48
72597372|NCT04000360|144726260|SUPERIORITY|Test of equality of annual slopes of log(TMT B to TMT A duration ratio) for AE and UCC groups.|Difference in slopes|-3.42|STANDARD_ERROR_OF_MEAN|6.06||1|TWO_SIDED|95.0|-15.31|8.46||Family-wise error controlled at α=0.05 by Holm-Bonferroni adjustment for other non-motor domain secondary outcomes: Processing Speed Test and Visual Memory Test.|Mixed Models Analysis||Visual attention and set switching speed decline with Parkinson's, hence duration of Trail Making Test B increases. The reported effect is the difference in annual slopes of (log TMT B/TMT A), i.e., change/year, between AE and UCC treatment arms.|Linear mixed model for baseline, 6 month, and 12 month data, with fixed effects of clinical site, treatment, and linear time nested in treatment arm, and compound symmetry covariance structure, fit by residual pseudolikelihood maximization (RSPL) in SAS PROC GLIMMIX. To reduce skew and better meet modeling assumptions, the ratios were transformed to their natural logarithms for modeling. Study sample size was based on the primary outcome, and power was not calculated for this and other outcomes.||8.46|-15.31|1.00
72597373|NCT04000360|144726261|SUPERIORITY|Test of equality of annual slopes of squared test score.|Difference in slopes|0.16|STANDARD_ERROR_OF_MEAN|1.4||0.91|TWO_SIDED|95.0|-2.58|2.91||Family-wise error controlled at α=0.05 by Holm-Bonferroni adjustment for other non-motor domain secondary outcomes: Processing Speed Test and Trail Making Test Ratio.|Mixed Models Analysis||Visual memory declines with Parkinson's, hence the score declines. The reported effect is the difference in annual slopes, i.e., changes in mean score\^2/year, for AE and UCC treatment arms, shown in hundreds. Higher slope indicates slower decline.|Linear mixed model for baseline, 6 month, and 12 month data, with fixed effects of clinical site, treatment, and linear time nested in treatment arm, and compound symmetry covariance structure, fit by residual pseudolikelihood maximization (RSPL) in SAS PROC GLIMMIX. To reduce skew and better meet modeling assumptions, the score was squared for statistical modeling. Sample size was based on the primary outcome, and power was not calculated for this and other outcomes.||2.91|-2.58|0.91
72597374|NCT03725033|144726298|SUPERIORITY|||||||0.0028|||||||Wilcoxon (Mann-Whitney)|||This analysis applies to ∆ between baseline and after 12 weeks row.||||0.0028
72597375|NCT03725033|144726299|SUPERIORITY|||||||0.0805|||||||Fisher Exact|||||||0.0805
72597376|NCT03725033|144726300|SUPERIORITY|||||||0.99|||||||Wilcoxon (Mann-Whitney)|||This analysis applies to ∆ between baseline and after 12 weeks row.||||0.99
72597377|NCT03725033|144726301|SUPERIORITY|||||||0.79|||||||Wilcoxon (Mann-Whitney)|||This analysis applies to ∆ between baseline and after 12 weeks row.||||0.79
72597378|NCT01900431|144726371|SUPERIORITY||Odds Ratio (OR)|2.1||||0.2354|TWO_SIDED|90.0|0.8|5.6||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel||Sarilumab 200 mg q2w vs Placebo|Analysis was performed using combined estimate for odds ratio obtained by combining the log-transformation of odds ratio from Cochran Mantel-Haenszel (CMH) analyses of the different imputed datasets, using Rubin's formulae, and then by back-transforming the combined estimate. The CMH analyses were adjusted for randomization stratification factor VH level (VH \>= 4 versus VH \<4).||5.6|0.8|0.2354
72597379|NCT01900431|144726372|SUPERIORITY||Least Square (LS) Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.29||0.0127|TWO_SIDED|90.0|-1.223|-0.262||Threshold for significance at 0.05 level.|Mixed Models Analysis||Sarilumab 200 mg q2w vs Placebo|Analysis was performed using mixed effect model with repeated measures (MMRM) with treatment groups, visits and visit-by-treatment groups interaction as fixed categorical effects, as well as, fixed continuous covariate of baseline adjudicated VH.||-0.262|-1.223|0.0127
72597380|NCT01900431|144726373|SUPERIORITY||Odds Ratio (OR)|0.95||||1|TWO_SIDED|90.0|0.11|6.093||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel||Sarilumab 200 mg q2w vs Placebo|Analysis was performed using common odds ratio which came from CMH analysis adjusted for randomization stratification factor VH level (VH \>=4 versus VH \<4).||6.093|0.11|1
72415724|NCT01302119|144342332|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
72597381|NCT01900431|144726374|SUPERIORITY||LS Mean Difference|5.8|STANDARD_ERROR_OF_MEAN|2.26||0.0153|TWO_SIDED|90.0|1.99|9.67||Threshold for significance at 0.05 level.|Mixed Models Analysis||Sarilumab 200 mg q2w vs Placebo|Analysis was performed using MMRM model with treatment groups, randomization strata of VH level (\<4, \>=4), visits and visit-by-treatment groups interaction as fixed categorical effects, as well as, fixed continuous covariate of baseline BCVA.||9.67|1.99|0.0153
72597382|NCT01900431|144726375|SUPERIORITY||LS Mean Difference|-26.5|STANDARD_ERROR_OF_MEAN|14.2||0.0683|TWO_SIDED|90.0|-50.41|-2.68||Threshold for significance at 0.05 level.|Mixed Models Analysis||Sarilumab 200 mg q2w vs Placebo|Analysis was performed using MMRM model with treatment groups, randomization strata of VH level (\<4, \>=4), visits and visit-by-treatment groups interaction as fixed categorical effects, as well as, fixed continuous covariate of baseline CRT (Automatic measurement from SD-OCT).||-2.68|-50.41|0.0683
72597383|NCT01900431|144726376|SUPERIORITY||LS Mean Difference|-6.4|STANDARD_ERROR_OF_MEAN|3.55||0.0825|TWO_SIDED|90.0|-12.374|-0.35||Threshold for significance at 0.05 level.|Mixed Models Analysis||Sarilumab 200 mg q2w vs Placebo|Analysis was performed using MMRM model with treatment groups, randomization strata of VH level (\<4, \>=4), visits and visit-by-treatment groups interaction as fixed categorical effects, as well as, fixed continuous covariate of baseline CRT (Automatic measurement from SD-OCT).||-0.35|-12.374|0.0825
72597384|NCT01900431|144726379|SUPERIORITY||Odds Ratio (OR)|1.07||||1|TWO_SIDED|90.0|0.306|3.845||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel||Sarilumab 200 mg q2w vs Placebo|Analysis was performed using common odds ratio which came from CMH analysis adjusted for randomization stratification factor VH level (VH \>=4 versus VH \<4).||3.845|0.306|1
72597385|NCT00603382|144726436|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.101||||0.095|TWO_SIDED|95.0|-0.018|0.221|||ANCOVA|||||0.221|-0.018|0.095
72597386|NCT00603382|144726436|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.129||||0.033|TWO_SIDED|95.0|0.011|0.247|||ANCOVA|||||0.247|0.011|0.033
72597387|NCT00603382|144726436|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.204|||<|0.001|TWO_SIDED|95.0|0.089|0.319|||ANCOVA|||||0.319|0.089|<0.001
72597388|NCT00603382|144726436|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.23|||<|0.001|TWO_SIDED|95.0|0.111|0.349|||ANCOVA|||||0.349|0.111|<0.001
72597389|NCT00603382|144726436|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.106||||0.074|TWO_SIDED|95.0|-0.01|0.223|||ANCOVA|||||0.223|-0.010|0.074
72597390|NCT03782974|144726459|SUPERIORITY||Least Square Mean Difference|-0.57|STANDARD_ERROR_OF_MEAN|0.104|<|0.0001|TWO_SIDED|95.0|-0.77|-0.37||The threshold for statistical significance was p=0.05|Mixed Models Analysis|||It was calculated that 138 participants randomized in a 1:1 ratio between the 2 arms would have a least 90% power to detect a difference of a big effect size between Proglucamune Treatment and Placebo from baseline to week 12.||-0.37|-0.77|<0.0001
72597391|NCT03782974|144726460|SUPERIORITY||Risk Difference (RD)|0.27|||<|0.0001|TWO_SIDED|95.0|0.1|0.59||The threshold for statistical significance was p=0.05.|Chi-squared|||It was calculated that 138 participants randomized in a 1:1 ratio between the 2 arms would have a least 90% power to detect a difference of a big effect size between Proglucamune Treatment and Placebo from baseline to week 12.||0.59|0.10|<0.0001
72597392|NCT03782974|144726461|SUPERIORITY||Least Square Mean Difference|6.35|||<|0.001|TWO_SIDED|95.0|3.93|8.77||The threshold for statistical significance was p=0.05.|Mixed Models Analysis|||It was calculated that 138 participants randomized in a 1:1 ratio between the 2 arms would have a least 90% power to detect a difference of a big effect size between Proglucamune Treatment and Placebo from baseline to week 12.||8.77|3.93|<0.001
72415725|NCT01302119|144342333|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
72415726|NCT01302119|144342334|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
72415727|NCT01302119|144342335|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
72597393|NCT03782974|144726462|SUPERIORITY||Least Square Mean Difference|4.049|||<|0.05|TWO_SIDED|95.0|1.08|7.01||The threshold for statistical significance was p=0.05.|Mixed Models Analysis|||It was calculated that 138 participants randomized in a 1:1 ratio between the 2 arms would have a least 90% power to detect a difference of a big effect size between Proglucamune Treatment and Placebo from baseline to week 12.||7.01|1.08|<0.05
72597394|NCT03782974|144726463|SUPERIORITY|||||||0.6||||||The threshold for statistical significance was p=0.05.|ANOVA|||||||0.6
72597395|NCT03782974|144726464|SUPERIORITY|||||||0.054||||||The threshold for statistical significance was p=0.05.|Mixed Models Analysis|||It was calculated that 138 participants randomized in a 1:1 ratio between the 2 arms would have a least 90% power to detect a difference of a big effect size between Proglucamune Treatment and Placebo from baseline to week 12.||||0.054
72597396|NCT03782974|144726465|SUPERIORITY|||||||0.13||||||The threshold for statistical significance was p=0.05.|Mixed Models Analysis|||It was calculated that 138 participants randomized in a 1:1 ratio between the 2 arms would have a least 90% power to detect a difference of a big effect size between Proglucamune Treatment and Placebo from baseline to week 12.||||0.13
72597397|NCT03782974|144726466|SUPERIORITY||Least Square Mean Difference|-0.76|STANDARD_ERROR_OF_MEAN|0.102|<|0.0001|TWO_SIDED|95.0|-0.96|-0.56||The threshold for statistical significance was p=0.05.|Mixed Models Analysis|||It was calculated that 138 participants randomized in a 1:1 ratio between the 2 arms would have a least 90% power to detect a difference of a big effect size between Proglucamune Treatment and Placebo from baseline to week 12.||-0.56|-0.96|<0.0001
72597398|NCT02993354|144726468|SUPERIORITY||Relative Rate|0.95||||0.75|TWO_SIDED|95.0|0.69|1.31|||t-test, 2 sided|||||1.31|0.69|0.75
72597399|NCT01783821|144726476|SUPERIORITY_OR_OTHER|||||||0.02|||||||Type 3 Wald Test|||Overall p-value of the day by treatment interaction from the random effects model using a type 3 Wald test.||||0.02
72597400|NCT01783821|144726477|SUPERIORITY_OR_OTHER|||||||0.01|||||||Fisher Exact|||Comparison between the two arms for the 3 categories.||||0.01
72597401|NCT01783821|144726478|SUPERIORITY_OR_OTHER|||||||0.01|||||||Chi-squared|||||||0.01
72597402|NCT01783821|144726479|SUPERIORITY_OR_OTHER|||||||0.01|||||||Fisher Exact|||||||0.01
72597403|NCT01783821|144726480|SUPERIORITY_OR_OTHER|||||||0.02|||||||Cox Proportional Hazard, Fine/Gray adj.|||||||0.02
72597404|NCT01783821|144726481|SUPERIORITY_OR_OTHER|||||||0.01|||||||Kruskal-Wallis|||||||0.01
72415728|NCT02235493|144342339|SUPERIORITY_OR_OTHER|||||||0.0625|TWO_SIDED|||||The p-value is based on a nonparametric sign test to determine whether the median of change from Baseline in MPOMA-G score differs from 0. No multiple comparisons or multiplicity adjustments were conducted.|Sign test|||Videos were reviewed and scored by 3 independent raters who were masked to patient identifiers and the clinic visits and dates when the videos were recorded. Each rater scored the individual components required for the calculation of the total MPOMA-G score for each evaluable patient video. The median of the scores across the 3 raters was obtained for each individual component and summed to generate the median MPOMA-G score used in the analyses.||||0.0625
72597405|NCT01907217|144726493|NON_INFERIORITY_OR_EQUIVALENCE|"The prespecified noninferiority margin was no more than a -4 point difference at the end of treatment between the bilateral and unilateral groups.~The predicted difference at the end of treatment was 1.08 (95% confidence interval \[CI\] = -1.67 to 3.84."|Mean Difference (Final Values)|1.08|||<|0.05|TWO_SIDED|95.0|-1.67|3.84||Primary statistical analysis was assessment of difference in HAM-D scores between arms at end-of-treatment, supplemented by 95% CIs and this interval compared with the pre-specified noninferiority threshold (-4 points). The p-value was calculated.|Regression, Linear|A regression model was fitted to end-of-treatment HAM-D measures, with baseline HAM-D scores, trial arm, randomization stratifiers as covariates.|The prespecified noninferiority margin was no more than a -4-point difference at the end of treatment between bitemporal and unilateral groups. The predicted difference at the end of treatment was 1.08 (95% confidence interval \[CI\]=-1.67 to 3.84).|Based on a large bitemporal ECT series, we estimated that 69 patients were required per group to have 80% power to demonstrate, using a one-sided equivalence t test at 5% level, that the mean reduction in the 24-item HAM-D score following high-dose unilateral ECT was no more than 4 points (i.e., equivalent to 3 points on the 17-item HAM-D, deemed to be clinically relevant \[30\]) less than that achieved using bitemporal ECT.||3.84|-1.67|<0.05
72597406|NCT01907217|144726494|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.66||||0.001|TWO_SIDED|95.0|0.51|0.85||As above|generalized linear models with a binomia|||"The AMI-SF at end of treatment was analyzed using generalized linear models with a binomial distribution and logit-link. Post treatment AMI-SF measures provide the number of baseline items recalled after ECT; such number of items recalled variables were therefore modeled as arising from binomial distributions, with maximum number of possible recalls set to the number of items obtained at baseline."||0.85|0.51|0.001
72597407|NCT01907217|144726495|SUPERIORITY||Odds Ratio (OR)|0.59||||0.001|TWO_SIDED|95.0|0.45|0.78|||Regression, Linear|Analyzed using a generalized linear models with a binomial distribution and logit-link.||||0.78|0.45|0.001
72597408|NCT01907217|144726496|SUPERIORITY||Odds Ratio (OR)|0.59||||0.001|TWO_SIDED|95.0|0.45|0.79|||Regression, Linear|generalized linear models with a binomial distribution and logit-link||||0.79|0.45|0.001
72597409|NCT03704948|144726499|SUPERIORITY||Mean Difference (Net)|0.82|||<|0.05|TWO_SIDED||||||Mixed Models Analysis|||||||<0.05
72597410|NCT01180049|144726510|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.731|||||TWO_SIDED|80.0|0.52|1.027||||||||1.027|0.520|
72597411|NCT01180049|144726511|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.778|||||TWO_SIDED|80.0|0.568|1.064||||||||1.064|0.568|
72597412|NCT01180049|144726512|SUPERIORITY_OR_OTHER||Difference in arms|6.7|||||TWO_SIDED|80.0|-6.9|20.3||||||Independent assessment- Difference (%) TEMSR 175/75 mg - TEMSR 75 mg (80% CI)||20.3|-6.9|
72597413|NCT01180049|144726513|SUPERIORITY_OR_OTHER||Difference between arms|13.3|||||TWO_SIDED|80.0|-0.4|26.7||||||Investigator's assessment- Difference (%)TEMSR 175/75 mg - TEMSR 75 mg (80% CI)||26.7|-0.4|
72597414|NCT01180049|144726514|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.646|||||TWO_SIDED|80.0|0.453|0.922||||||||0.922|0.453|
72597415|NCT00350779|144726526|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.72|STANDARD_DEVIATION|0.87|<|0.001||95.0|-0.95|-0.49|||ANCOVA|Model terms: treatment; baseline; prior anti-hyperglycemic therapy||||-0.49|-0.95|<0.001
72597416|NCT00350779|144726527|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-19.0|STANDARD_DEVIATION|31.3|<|0.001||95.0|-27.2|-10.9|||ANCOVA|Model terms: treatment; baseline; prior anti-hyperglycemic therapy||||-10.9|-27.2|<0.001
72597417|NCT00350779|144726528|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-37.9|STANDARD_DEVIATION|43.7|<|0.001||95.0|-50.2|-25.5|||ANCOVA|Model terms: treatment; baseline; prior anti-hyperglycemic therapy||||-25.5|-50.2|<0.001
72597418|NCT00350779|144726529|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.77|STANDARD_DEVIATION|1.04|<|0.001||95.0|-1.04|-0.5|||ANCOVA|Model terms: treatment; baseline; prior anti-hyperglycemic therapy||||-0.50|-1.04|<0.001
72421604|NCT03720938|144354381|SUPERIORITY||||||‬|2.82e-05||||||Linear mixed-effects model fit by maximum likelihood since restricted maximum likelihood assumes a strong normality.|Linear mixed-effects model|Adjusted by Satterthwaite's degrees of freedom method for cluster effect, and small sample sizes in addition to baseline value and age.||Null hypothesis was the absence of difference between the two groups for the dependent variable visual reaction time.||||0.0000282‬
72597419|NCT00350779|144726530|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-17.4|STANDARD_DEVIATION|34.6|<|0.001||95.0|-26.4|-8.4|||ANCOVA|Model terms: treatment; baseline; prior anti-hyperglycemic therapy||||-8.4|-26.4|<0.001
72597420|NCT00350779|144726531|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-34.1|STANDARD_DEVIATION|51.0|<|0.001||95.0|-48.4|-19.9|||ANCOVA|Model terms: treatment; baseline; prior anti-hyperglycemic therapy||||-19.9|-48.4|<0.001
72597421|NCT01687283|144726535|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was demonstrated if the lower limit of the two-sided 95% confidence interval for the treatment difference (FP minus BUD) in the mean change from baseline in daily AM PEF averaged over the 12 week treatment period was greater than -12 L/min.|Mean Difference (Net)|-1.8||||0.733|TWO_SIDED|95.0|-12.19|8.59||Analysis performed using ANCOVA with covariates of baseline, center, sex, age and treatment|ANCOVA||The analysis only included participants who had at least 4 days of non-missing AM PEF data in the baseline week prior to randomization and at least 4 days of non-missing AM PEF data after randomization.|||8.59|-12.19|0.733
72597422|NCT01687283|144726536|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was demonstrated if the lower limit of the two-sided 95% confidence interval for the treatment difference (FP minus BUD) in the mean change from baseline in daily AM PEF averaged over the 12 week treatment period was greater than -12 L/min.|Mean Difference (Net)|-2.28||||0.674|TWO_SIDED|95.0|-12.95|8.38|||ANCOVA|||||8.38|-12.95|0.674
72597423|NCT01687283|144726537|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.77||||0.579|TWO_SIDED|95.0|-12.57|7.04|||ANCOVA|||||7.04|-12.57|0.579
72597424|NCT01687283|144726538|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.62||||0.854|TWO_SIDED|95.0|-6.0|7.24|||ANCOVA|||||7.24|-6.00|0.854
72597425|NCT01687283|144726539|SUPERIORITY_OR_OTHER|||||||0.123|||||||Wilcoxon rank sum test|||This statistical analysis is for comparison of FP 1 mg BID and BUD 2 mg BID in median day-time symptom score||||0.123
72597426|NCT01687283|144726539|SUPERIORITY_OR_OTHER|||||||0.949|||||||Wilcoxon rank sum test.|||This statistical analysis is for comparison of FP 1 mg BID and BUD 2 mg BID in median night-time symptom score||||0.949
72597427|NCT01687283|144726540|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.74||||0.204|TWO_SIDED|95.0|-12.07|2.59|||ANCOVA|||||2.59|-12.07|0.204
72597428|NCT01687283|144726541|SUPERIORITY_OR_OTHER|||||||0.17||95.0|||||Wilcoxon Rank sum|||||||0.170
72415729|NCT02235493|144342340|SUPERIORITY_OR_OTHER|||||||0.125|TWO_SIDED|||||The p-value is based on a nonparametric sign test to determine whether the median of change from Baseline in POMA-G score differs from 0. No multiple comparisons or multiplicity adjustments were conducted.|Sign test|||Videos were reviewed and scored by 3 independent raters who were masked to patient identifiers and the clinic visits and dates when the videos were recorded. Each rater scored the individual components required for the calculation of the total POMA-G score for each evaluable patient video. The median of the scores across the 3 raters was obtained for each individual component and summed to generate the median POMA-G score used in the analyses.||||0.1250
72415730|NCT01055769|144342341|NON_INFERIORITY_OR_EQUIVALENCE|The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. Linezolid 600 mg oral suspension was the Test treatment, while linezolid 600 mg tablet was the Reference treatment.|Adjusted Geometric Means Ratio|97.81|||||TWO_SIDED|90.0|93.11|102.75||||||Natural log transformed AUClast of linezolid was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||102.75|93.11|
72597429|NCT01687283|144726542|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.039||||0.337|TWO_SIDED|95.0|-0.118|0.041||Repeated Measures analysis adjusted for baseline, centre, sex, age, visit, treatment, visit by treatment interaction and visit by baseline interaction|ANCOVA|||This statistical analysis is for comparison of FP 1 mg BID and BUD 2 mg BID in Change of clinical lung function measurement FEV1 at Week 2||0.041|-0.118|0.337
72597430|NCT01687283|144726542|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.008||||0.866|TWO_SIDED|95.0|-0.101|0.085||Repeated Measures analysis adjusted for baseline, center, sex, age, visit, treatment, visit by treatment interaction and visit by baseline interaction.|ANCOVA|||This statistical analysis is for comparison of FP 1 mg BID and BUD 2 mg BID in Change of clinical lung function measurement FEV1 at Week 4||0.085|-0.101|0.866
72597431|NCT01687283|144726542|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.025||||0.566|TWO_SIDED|95.0|-0.113|0.062||Repeated Measures analysis adjusted for baseline, center, sex, age, visit, treatment, visit by treatment interaction and visit by baseline interaction|ANCOVA|||This statistical analysis is for comparison of FP 1 mg BID and BUD 2 mg BID in Change of clinical lung function measurement FEV1 at Week 8||0.062|-0.113|0.566
72597432|NCT01687283|144726542|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.017||||0.727|TWO_SIDED|95.0|-0.078|0.112||Repeated Measures analysis adjusted for baseline, center, sex, age, visit, treatment, visit by treatment interaction and visit by baseline interaction.|ANCOVA|||This statistical analysis is for comparison of FP 1 mg BID and BUD 2 mg BID in Change of clinical lung function measurement FEV1 at Week 12||0.112|-0.078|0.727
72597433|NCT01663857|144726550|SUPERIORITY|||||||0.4|||||||Log Rank|||||||0.4
72597434|NCT01663857|144726552|SUPERIORITY|||||||0.4686|||||||Log Rank|||||||0.4686
72597435|NCT03041467|144726555|SUPERIORITY||||||<|0.001|||||||One-sided Z-test|||||||<0.001
72597436|NCT03041467|144726556|NON_INFERIORITY|Non-inferiority p-values for the primary safety endpoint was based on the Farrington-Manning non-inferiority test with a margin of 7.5%.||||||0.002|||||||Farrington-Manning Test|||||||0.002
72597437|NCT03041467|144726557|SUPERIORITY||||||<|0.001||||||There is no planned hypothesis test other than at 6 months time point. P-value listed is at 6 months.|Log Rank|||Kaplan-Meier method was used to estimate access circuit primary patency.||||<0.001
72597438|NCT03041467|144726558|OTHER|There is no planned hypothesis test other than at 6 months time point. P-value listed is at 6 months.|||||<|0.001||||||There is no planned hypothesis test other than at 6 months time point. P-value listed is at 6 months. Survival analysis was performed using Kaplan-Meier method.|Log Rank|||Kaplan-Meier method was used to estimate target lesion primary patency.|Survival analysis was performed using Kaplan-Meier method.|||<0.001
72597439|NCT03041467|144726559|SUPERIORITY||||||<|0.001||||||There is no planned hypothesis test other than at 6 months time point. P-value listed is at 6 months.|Chi-squared|||||||<0.001
72597440|NCT03041467|144726563|SUPERIORITY||||||>|0.999|||||||Chi-squared|||||||>0.999
72597441|NCT03041467|144726564|SUPERIORITY|||||||0.482|||||||Chi-squared|||||||0.482
72597442|NCT03041467|144726565|SUPERIORITY||||||>|0.999|||||||Chi-squared|||||||>0.999
72597443|NCT03052920|144726575|SUPERIORITY||||||<|0.001||||||The threshold for statistical significance was \<=0.05|t-test, 2 sided|t(35) = 11.29||Mean difference in percent correct for CNC words at 6 months post-implant and pre-implant is reported.||||<0.001
72597444|NCT03052920|144726576|SUPERIORITY||||||<|0.001||||||The threshold for statistical significance was \<=0.05|t-test, 2 sided|t(35) = 16.947||Mean difference in Soundfield thresholds (averaged across the frequency range in dB HL) at 6 months post-implant and pre-implant is reported.||||<0.001
72597445|NCT03052920|144726577|SUPERIORITY||||||<|0.05||||||The threshold for statistical significance was \<= 0.05|t-test, 2 sided|t(35) = 2.14||Mean difference in degrees RMS error at 6 months post-implant and pre-implant is reported.||||<0.05
72597446|NCT03052920|144726578|SUPERIORITY||||||<|0.001||||||The threshold for statistical significance was \<= 0.05.|t-test, 2 sided|t(35) = 4.02||Mean difference in percentage of understanding (words correct) at 6 months post-implant and pre-implant is reported.||||<0.001
72597447|NCT03052920|144726579|SUPERIORITY||||||<|0.05||||||The threshold for statistical significance was \<= 0.05.|t-test, 2 sided|t(35) = 2.58||Mean difference in AzBio sentence scores in noise at 6 months post-implant and pre-implant is reported.||||<0.05
72597448|NCT03052920|144726580|SUPERIORITY||||||<|0.01||||||The threshold for statistical significance was \<= 0.05.|t-test, 2 sided|t(35) = 3.16||Mean difference in dB SNR for BKB-SIN sentences with noise to the better ear at 6-months post-implant and pre-implant is reported.||||<0.01
72597449|NCT03052920|144726581|SUPERIORITY||||||<|0.001||||||The threshold for statistical significance was \<= 0.05.|t-test, 2 sided|t(35) = 10.42||Mean difference in AzBio sentence scores at 60 dB SPL for the poor ear alone at 6 months post-implant and pre-implant is reported.||||<0.001
72597450|NCT03052920|144726582|SUPERIORITY||||||<|0.001||||||The threshold for statistical significance was \<= 0.05.|t-test, 2 sided|t(38) = 7.15||Mean difference in HHIE reported scores at 6-months post-implant and pre-implant is reported.||||<0.001
72597451|NCT03052920|144726583|SUPERIORITY||||||<|0.001||||||The threshold for statistical significance was \<= 0.05.|t-test, 2 sided|t(38) = 4.34||Mean difference in HUI3 ratings at 6 months post-implant and pre-implant is reported.||||<0.001
72597452|NCT03052920|144726584|SUPERIORITY||||||<|0.001||||||The threshold for statistical significance was \<= 0.05.|t-test, 2 sided|t(38) = 7.71||Mean difference in ratings for the SSQ total score at 6 months post-implant and pre-implant is reported.||||<0.001
72597453|NCT03052920|144726585|SUPERIORITY||||||<|0.001||||||The threshold for statistical significance was \<= 0.05.|t-test, 2 sided|t(38) = 7.90||Mean difference in SSQ ratings at 12 months post-implant and pre-implant is reported.||||<0.001
72597454|NCT03052920|144726586|SUPERIORITY||||||<|0.05||||||The threshold for statistical significance was \<= 0.05.|t-test, 2 sided|t(38) = 2.31||Mean difference in SADL scores at 6 months post-implant and pre-implant are reported.||||<0.05
72597455|NCT03052920|144726587|SUPERIORITY||||||<|0.001||||||The threshold for statistical significance was \<= 0.05.|t-test, 2 sided|t(25) = 7.27||Mean difference in the CPHI scores at 6 months post-implant and pre-implant are reported.||||<0.001
72597456|NCT03052920|144726588|SUPERIORITY||||||<|0.001||||||The threshold for statistical significance was \<= 0.05.|t-test, 2 sided|t(25) = 7.65||Mean difference in HII-SOP scores at 6 months post-implant and pre-implant is reported.||||<0.001
72421605|NCT03720938|144354382|SUPERIORITY|||||||0||||||The outcome of visual reaction time of non-dominant hand was tested for any difference between groups.|ANCOVA|Adjusted for the visual reaction time of non-dominant hand at baseline and confounding variable age.||Null hypothesis was the absence of difference between the two groups for the dependent variable visual reaction time of non-dominant hand.||||0.000
72597457|NCT03052920|144726589|SUPERIORITY||||||<|0.05||||||The threshold for statistical significance was \<= 0.05.|t-test, 2 sided|t(35) = 2.34||Mean difference in the dB SNR scores for BKB-SIN sentences at 6 months post-implant minus pre-implant is reported.||||<0.05
72597458|NCT04847232|144726702|OTHER|Test of HR = 1|Hazard Ratio (HR)|0.98||||0.867|TWO_SIDED|95.0|0.76|1.26|||Regression, Cox||SZC relative to Placebo|||1.26|0.76|0.867
72597459|NCT04847232|144726703|OTHER|Test of OR = 1|Odds Ratio (OR)|3.36|||<|0.0001|TWO_SIDED|95.0|2.64|4.26|||Regression, Logistic||SZC relative to Placebo|||4.26|2.64|<.0001
72597460|NCT04847232|144726704|OTHER|Test of HR = 1|Hazard Ratio (HR)|1.12||||0.51|TWO_SIDED|95.0|0.8|1.56|||Regression, Cox||SZC relative to Placebo|||1.56|0.80|0.510
72597461|NCT02290925|144726713|OTHER|general linear model (GLM) with repeated measures|Mean Difference (Net)|0.25|||||TWO_SIDED||||||||Box's M tests was used. Mauchly's test was used to verify that the error covariance matrix of the orthonormalized-transformed dependent variables is proportional to an identity matrix.||"We used intention to treat analysis. Since the missing data were more than 5%, we examined the dataset to determine whether it shows missing completely at random (MCAR) not missing at random (NMAR) or data missing at random (MAR). A sensitivity analysis was done to determine whether multiple imputations are required. It included complete case analysis, best-worst case and worst best case scenario with group mean±1SD."|||
72597462|NCT04348500|144726736|SUPERIORITY|||||||0.1||||||P-value was not adjusted.|Chi-squared|||The null hypothesis is that there is no difference in the use of clazakizumab as a treatment compared to placebo in reducing or eliminating the incidence of severe adverse events among patients with COVID-19.||||0.10
72597463|NCT04348500|144726742|SUPERIORITY|||||||0.1||||||P-value was not adjusted.|Fisher Exact|||Null hypothesis is that there is no change in the need for mechanical ventilation and/or ECMO at 14 days after the first administered dose in comparison to placebo.||||0.10
72597464|NCT01410240|144726743|SUPERIORITY_OR_OTHER|||||||0.453|||||||one-sided, two-sample t-test|||||||0.453
72597465|NCT01410240|144726744|SUPERIORITY_OR_OTHER|||||||0.708|||||||one-sided, two-sample t-test|||||||0.708
72597466|NCT01410240|144726745|SUPERIORITY_OR_OTHER|||||||0.527|||||||one-sided, two-sample t-test|||||||0.527
72597467|NCT01410240|144726746|SUPERIORITY_OR_OTHER|||||||0.561|||||||one-sided Wilcoxon rank sum test|||||||0.561
72597468|NCT01410240|144726747|SUPERIORITY_OR_OTHER|||||||0.356|||||||one-sided Wilcoxon rank sum test|||||||0.356
72597469|NCT01410240|144726748|SUPERIORITY_OR_OTHER|||||||0.533|||||||one-sided Wilcoxon rank sum test|||||||0.533
72597470|NCT01410240|144726749|SUPERIORITY_OR_OTHER|||||||0.734|||||||two-sided Wilcoxon rank sum test|||||||0.734
72597471|NCT01410240|144726752|SUPERIORITY_OR_OTHER|||||||0.314|||||||two-sided Wilcoxon rank sum test|||||||0.314
72597472|NCT01410240|144726753|SUPERIORITY_OR_OTHER|||||||0.063|||||||two-sided Wilcoxon rank sum test|||||||0.063
72597473|NCT01410240|144726756|SUPERIORITY_OR_OTHER|||||||0.058|||||||two-sided Wilcoxon rank sum test|||||||0.058
72597474|NCT01410240|144726757|SUPERIORITY_OR_OTHER|||||||0.421|||||||two-sided Wilcoxon rank sum test|||||||0.421
72597475|NCT01410240|144726758|SUPERIORITY_OR_OTHER|||||||0.161|||||||two-sided Wilcoxon rank sum test|||||||0.161
72597476|NCT01410240|144726759|SUPERIORITY_OR_OTHER|||||||0.016|||||||two-sided Wilcoxon rank sum test|||||||0.016
72597477|NCT01410240|144726761|SUPERIORITY_OR_OTHER|||||||0.534|||||||two-sided Wilcoxon rank sum test|||Change Day 3: Pain||||0.534
72597478|NCT01410240|144726761|SUPERIORITY_OR_OTHER|||||||0.269|||||||two-sided Wilcoxon rank sum test|||Change Day 3: Stiffness||||0.269
72597479|NCT01410240|144726761|SUPERIORITY_OR_OTHER|||||||0.693|||||||two-sided Wilcoxon rank sum test|||Change Day 3: Physical Functioning||||0.693
72597480|NCT01410240|144726761|SUPERIORITY_OR_OTHER|||||||0.343|||||||two-sided Wilcoxon rank sum test|||Change Day 3: Average Score||||0.343
72597481|NCT01410240|144726761|SUPERIORITY_OR_OTHER|||||||0.343|||||||two-sided Wilcoxon rank sum test|||Change Day 3: Total Score||||0.343
72597482|NCT01410240|144726761|SUPERIORITY_OR_OTHER|||||||0.978|||||||two-sided Wilcoxon rank sum test|||Change Week 1: Pain||||0.978
72597483|NCT01410240|144726761|SUPERIORITY_OR_OTHER|||||||0.709|||||||two-sided Wilcoxon rank sum test|||Change Week 1: Stiffness||||0.709
72597484|NCT01410240|144726761|SUPERIORITY_OR_OTHER|||||||0.594|||||||two-sided Wilcoxon rank sum test|||Change Week 1: Physical Functioning||||0.594
72597485|NCT01410240|144726761|SUPERIORITY_OR_OTHER|||||||0.501|||||||two-sided Wilcoxon rank sum test|||Change Week 1: Average Score||||0.501
72597486|NCT01410240|144726761|SUPERIORITY_OR_OTHER|||||||0.501|||||||two-sided Wilcoxon rank sum test|||Change Week 1: Total Score||||0.501
72597487|NCT01410240|144726761|SUPERIORITY_OR_OTHER|||||||0.171|||||||two-sided Wilcoxon rank sum test|||Change Week 2: Pain||||0.171
72597488|NCT01410240|144726761|SUPERIORITY_OR_OTHER|||||||0.077|||||||two-sided Wilcoxon rank sum test|||Change Week 2: Stiffness||||0.077
72597489|NCT01410240|144726761|SUPERIORITY_OR_OTHER|||||||0.026|||||||two-sided Wilcoxon rank sum test|||Change Week 2: Physical Functioning||||0.026
72597490|NCT01410240|144726761|SUPERIORITY_OR_OTHER|||||||0.012|||||||two-sided Wilcoxon rank sum test|||Change Week 2: Average Score||||0.012
72597491|NCT01410240|144726761|SUPERIORITY_OR_OTHER|||||||0.012|||||||two-sided Wilcoxon rank sum test|||Change Week 2: Total Score||||0.012
72597492|NCT01410240|144726761|SUPERIORITY_OR_OTHER|||||||0.126|||||||two-sided Wilcoxon rank sum test|||Change Week 6: Pain||||0.126
72597493|NCT01410240|144726761|SUPERIORITY_OR_OTHER|||||||0.044|||||||two-sided Wilcoxon rank sum test|||Change Week 6: Stiffness||||0.044
72597494|NCT01410240|144726761|SUPERIORITY_OR_OTHER|||||||0.153||||||Change Week 6: Physical Functioning|two-sided Wilcoxon rank sum test|||||||0.153
72597495|NCT01410240|144726761|SUPERIORITY_OR_OTHER|||||||0.134|||||||two-sided Wilcoxon rank sum test|||Change Week 6: Average Score||||0.134
72415731|NCT01055769|144342342|NON_INFERIORITY_OR_EQUIVALENCE|The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. Linezolid 600 mg oral suspension was the Test treatment, while linezolid 600 mg tablet was the Reference treatment.|Adjusted Geometric Means Ratio|113.67|||||TWO_SIDED|90.0|105.26|122.75||||||Natural log transformed Cmax of linezolid was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||122.75|105.26|
72421606|NCT03720938|144354382|SUPERIORITY|||||||9e-08||||||Linear mixed-effects model fit by maximum likelihood since restricted maximum likelihood assumes a strong normality.|Linear mixed-effects model|Adjusted for cluster effect in addition to baseline value and age.||Null hypothesis was the absence of difference between the two groups for the dependent variable visual reaction time of non-dominant hand.||||0.00000009
72597496|NCT01410240|144726761|SUPERIORITY_OR_OTHER|||||||0.134|||||||two-sided Wilcoxon rank sum test|||Change Week 6: Total Score||||0.134
72597497|NCT01410240|144726763|SUPERIORITY_OR_OTHER|||||||0.962|||||||two-sided Wilcoxon rank sum test|||Change Week 1: Physical Functioning||||0.962
72597498|NCT01410240|144726763|SUPERIORITY_OR_OTHER|||||||0.714|||||||two-sided Wilcoxon rank sum test|||Change Week 1: Role-Physical||||0.714
72597499|NCT01410240|144726763|SUPERIORITY_OR_OTHER|||||||0.668|||||||two-sided Wilcoxon rank sum test|||Change Week 1: Bodily Pain||||0.668
72597500|NCT01410240|144726763|SUPERIORITY_OR_OTHER|||||||0.556|||||||two-sided Wilcoxon rank sum test|||Change Week 1: General Health||||0.556
72597501|NCT01410240|144726763|SUPERIORITY_OR_OTHER|||||||0.705|||||||two-sided Wilcoxon rank sum test|||Change Week 1: Vitality||||0.705
72597502|NCT01410240|144726763|SUPERIORITY_OR_OTHER|||||||0.122|||||||two-sided Wilcoxon rank sum test|||Change Week 1: Social Functioning||||0.122
72597503|NCT01410240|144726763|SUPERIORITY_OR_OTHER|||||||0.254|||||||two-sided Wilcoxon rank sum test|||Change Week 1: Role-Emotional||||0.254
72597504|NCT01410240|144726763|SUPERIORITY_OR_OTHER|||||||0.5|||||||two-sided Wilcoxon rank sum test|||Change Week 1: Mental Health||||0.500
72597505|NCT01410240|144726763|SUPERIORITY_OR_OTHER|||||||0.849|||||||two-sided Wilcoxon rank sum test|||Change Week 1: Physical Component Summary||||0.849
72597506|NCT01410240|144726763|SUPERIORITY_OR_OTHER|||||||0.959|||||||Wilcoxon (Mann-Whitney)|||Change Week 1: Mental Component Summary||||0.959
72597507|NCT01410240|144726763|SUPERIORITY_OR_OTHER|||||||0.574|||||||two-sided Wilcoxon rank sum test|||Change Week 2: Physical Functioning||||0.574
72597508|NCT01410240|144726763|SUPERIORITY_OR_OTHER|||||||0.524|||||||two-sided Wilcoxon rank sum test|||Change Week 2: Role-Physical||||0.524
72597509|NCT01410240|144726763|SUPERIORITY_OR_OTHER|||||||0.049|||||||two-sided Wilcoxon rank sum test|||Change Week 2: Bodily Pain||||0.049
72597510|NCT01410240|144726763|SUPERIORITY_OR_OTHER|||||||0.447|||||||two-sided Wilcoxon rank sum test|||Change Week 2: General Health||||0.447
72597511|NCT01410240|144726763|SUPERIORITY_OR_OTHER|||||||0.823|||||||two-sided Wilcoxon rank sum test|||Change Week 2: Vitality||||0.823
72597512|NCT01410240|144726763|SUPERIORITY_OR_OTHER|||||||0.661|||||||two-sided Wilcoxon rank sum test|||Change Week 2: Social Functioning||||0.661
72597513|NCT01410240|144726763|SUPERIORITY_OR_OTHER|||||||0.086|||||||two-sided Wilcoxon rank sum test|||Change Week 2: Role-Emotional||||0.086
72597514|NCT01410240|144726763|SUPERIORITY_OR_OTHER|||||||0.635|||||||two-sided Wilcoxon rank sum test|||Change Week 2: Mental Health||||0.635
72597515|NCT01410240|144726763|SUPERIORITY_OR_OTHER|||||||0.481|||||||two-sided Wilcoxon rank sum test|||Change Week 2: Physical Component Summary||||0.481
72597516|NCT01410240|144726763|SUPERIORITY_OR_OTHER|||||||0.14|||||||two-sided Wilcoxon rank sum test|||Change Week 2: Mental Component Summary||||0.140
72597517|NCT01410240|144726763|SUPERIORITY_OR_OTHER|||||||0.107|||||||two-sided Wilcoxon rank sum test|||Change Week 6: Physical Functioning||||0.107
72597518|NCT01410240|144726763|SUPERIORITY_OR_OTHER|||||||0.298|||||||two-sided Wilcoxon rank sum test|||Change Week 6: Role-Physical||||0.298
72597519|NCT01410240|144726763|SUPERIORITY_OR_OTHER|||||||0.071|||||||two-sided Wilcoxon rank sum test|||Change Week 6: Bodily Pain||||0.071
72597520|NCT01410240|144726763|SUPERIORITY_OR_OTHER|||||||0.94|||||||two-sided Wilcoxon rank sum test|||Change Week 6: General Health||||0.940
72597521|NCT01410240|144726763|SUPERIORITY_OR_OTHER|||||||0.293|||||||two-sided Wilcoxon rank sum test|||Change Week 6: Vitality||||0.293
72597522|NCT01410240|144726763|SUPERIORITY_OR_OTHER|||||||0.265|||||||two-sided Wilcoxon rank sum test|||Change Week 6: Social Functioning||||0.265
72597523|NCT01410240|144726763|SUPERIORITY_OR_OTHER|||||||0.036|||||||two-sided Wilcoxon rank sum test|||Change Week 6: Role-Emotional||||0.036
72597524|NCT01410240|144726763|SUPERIORITY_OR_OTHER|||||||0.307|||||||two-sided Wilcoxon rank sum test|||Change Week 6: Mental Health||||0.307
72597525|NCT01410240|144726763|SUPERIORITY_OR_OTHER|||||||0.448|||||||two-sided Wilcoxon rank sum test|||Change Week 6: Physical Component Summary||||0.448
72597526|NCT01410240|144726763|SUPERIORITY_OR_OTHER|||||||0.255|||||||two-sided Wilcoxon rank sum test|||Change Week 6: Mental Component Summary||||0.255
72597527|NCT01410240|144726765|SUPERIORITY_OR_OTHER|||||||0.052|||||||two-sided Wilcoxon rank sum test|||||||0.052
72597528|NCT05460078|144726785|SUPERIORITY||Odds Ratio (OR)|1.39|||<|0.001|TWO_SIDED|95.0|1.16|1.68|||Mixed Models Analysis|||||1.68|1.16|<0.001
72597529|NCT05460078|144726786|SUPERIORITY||Odds Ratio (OR)|1.39|||<|0.001|TWO_SIDED|95.0|1.18|1.65|||Mixed Models Analysis|||||1.65|1.18|<0.001
72597530|NCT05460078|144726787|SUPERIORITY||Odds Ratio (OR)|1.96|||<|0.001|TWO_SIDED|95.0|1.54|2.48|||Mixed Models Analysis|||||2.48|1.54|<0.001
72597531|NCT05460078|144726788|SUPERIORITY||Odds Ratio (OR)|1.4|||<|0.001|TWO_SIDED|95.0|1.17|1.66|||Mixed Models Analysis|||||1.66|1.17|<0.001
72597532|NCT00592592|144726822|OTHER||Cumulative incidence|10.9|||||TWO_SIDED|95.0|5.7|18.0||||||||18.0|5.7|
72597533|NCT00592592|144726824|OTHER||% hypothalamus normal tissue spared|88.0|||<|0.01|TWO_SIDED||||||t-test, 2 sided|Paired t-test||||||<0.01
72597534|NCT00592592|144726824|OTHER||% pituitary normal tissue spared|73.0|||<|0.01|TWO_SIDED||||||t-test, 2 sided|Paired t-test||||||<0.01
72597535|NCT00592592|144726824|OTHER||% lens (contra) normal tissue spared|100.0|||<|0.01|TWO_SIDED||||||t-test, 2 sided|Paired t-test||||||<0.01
72597536|NCT00592592|144726824|OTHER||% maxilla normal tissue spared|42.0||||0.02|TWO_SIDED||||||t-test, 2 sided|Paired t-test||||||0.02
72597537|NCT00592592|144726825|OTHER||Percent Survival, Local Control|80.9|||||TWO_SIDED|95.0|73.0|87.7||||||||87.7|73.0|
72597538|NCT02005627|144726827|SUPERIORITY||||||<|0.05||||||calculated|t-test, 2 sided|||||||<0.05
72597539|NCT02005627|144726830|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
72597540|NCT02005627|144726831|SUPERIORITY|||||||||||||||||Null Hypothesis was no difference between Grazax and Placebo treatment at 12 months. 80% power to detect 30% difference in total nasal symptom score (TNSS) after nasal challenge|Comparison of nasal symptom score at 0-60 mins after nasal challenge after 12 months treatment with Grazax compared to Placebo treatment. Mixed model analysis. 80% power to detect a 30% difference at p\<0.05.|||
72597541|NCT00938587|144726832|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.73|STANDARD_ERROR_OF_MEAN|0.291||0.0141|TWO_SIDED|90.0|-1.21|-0.24|||MMRM|||Day 14: Treatment difference and its corresponding 90 percent (%) confidence interval (CI) was based on least squares (LS) mean difference using mixed-model repeated measure (MMRM) where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and compound symmetry (CS) as covariance structure.||-0.24|-1.21|0.0141
72597542|NCT00938587|144726832|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.26|STANDARD_ERROR_OF_MEAN|0.283|<|0.0001|TWO_SIDED|90.0|-1.73|-0.79|||MMRM|||Day 14: Treatment difference and its corresponding 90 % CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||-0.79|-1.73|<0.0001
72597543|NCT00938587|144726833|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.45|STANDARD_ERROR_OF_MEAN|1.865||0.437|TWO_SIDED|90.0|-4.54|1.63|||MMRM|||Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||1.63|-4.54|0.4370
72597544|NCT00938587|144726833|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-2.5|STANDARD_ERROR_OF_MEAN|1.858||0.1802|TWO_SIDED|90.0|-5.58|0.57|||MMRM|||Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||0.57|-5.58|0.1802
72597545|NCT00938587|144726833|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.96|STANDARD_ERROR_OF_MEAN|1.832||0.6012|TWO_SIDED|90.0|-3.99|2.07|||MMRM|||Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||2.07|-3.99|0.6012
72597546|NCT00938587|144726833|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-2.01|STANDARD_ERROR_OF_MEAN|1.834||0.2753|TWO_SIDED|90.0|-5.04|1.03|||MMRM|||Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||1.03|-5.04|0.2753
72597547|NCT00938587|144726833|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.49|STANDARD_ERROR_OF_MEAN|1.844||0.7892|TWO_SIDED|90.0|-2.56|3.55|||MMRM|||Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||3.55|-2.56|0.7892
72597548|NCT00938587|144726833|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.72|STANDARD_ERROR_OF_MEAN|1.937||0.3765|TWO_SIDED|90.0|-4.92|1.49|||MMRM|||Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||1.49|-4.92|0.3765
72597549|NCT00938587|144726833|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-3.59|STANDARD_ERROR_OF_MEAN|1.873||0.0571|TWO_SIDED|90.0|-6.69|-0.49|||MMRM|||Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||-0.49|-6.69|0.0571
72597550|NCT00938587|144726833|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.85|STANDARD_ERROR_OF_MEAN|1.896||0.6553|TWO_SIDED|90.0|-3.99|2.29|||MMRM|||Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||2.29|-3.99|0.6553
72597551|NCT00938587|144726833|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-2.72|STANDARD_ERROR_OF_MEAN|1.847||0.1427|TWO_SIDED|90.0|-5.78|0.33|||MMRM|||Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||0.33|-5.78|0.1427
72597552|NCT00938587|144726833|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.87|STANDARD_ERROR_OF_MEAN|1.873||0.643|TWO_SIDED|90.0|-2.23|3.97|||MMRM|||Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||3.97|-2.23|0.6430
72597553|NCT00938587|144726833|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.04|STANDARD_ERROR_OF_MEAN|1.918||0.5868|TWO_SIDED|90.0|-2.13|4.22|||MMRM|||Day 42: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||4.22|-2.13|0.5868
72597554|NCT00938587|144726833|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.02|STANDARD_ERROR_OF_MEAN|1.873||0.586|TWO_SIDED|90.0|-4.12|2.08|||MMRM|||Day 42: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||2.08|-4.12|0.5860
72597555|NCT00938587|144726833|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.84|STANDARD_ERROR_OF_MEAN|1.879||0.3288|TWO_SIDED|90.0|-1.27|4.95|||MMRM|||Day 42: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||4.95|-1.27|0.3288
72415732|NCT01055769|144342343|NON_INFERIORITY_OR_EQUIVALENCE|The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. Linezolid 600 mg oral suspension was the Test treatment, while linezolid 600 mg tablet was the Reference treatment.|Adjusted Geometric means ratio|97.65|||||TWO_SIDED|90.0|92.92|102.63||||||Natural log transformed AUCinf of linezolid was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||102.63|92.92|
72597556|NCT00938587|144726833|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.23|STANDARD_ERROR_OF_MEAN|1.846||0.9027|TWO_SIDED|90.0|-3.28|2.83|||MMRM|||Day 42: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||2.83|-3.28|0.9027
72597557|NCT00938587|144726833|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.8|STANDARD_ERROR_OF_MEAN|1.871||0.671|TWO_SIDED|90.0|-2.3|3.89|||MMRM|||Day 42: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||3.89|-2.30|0.6710
72597558|NCT00938587|144726834|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.23|STANDARD_ERROR_OF_MEAN|1.123||0.837|TWO_SIDED|90.0|-1.63|2.09|||MMRM|||Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||2.09|-1.63|0.8370
72597559|NCT00938587|144726834|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.96|STANDARD_ERROR_OF_MEAN|1.12||0.0819|TWO_SIDED|90.0|-3.81|-0.11|||MMRM|||Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||-0.11|-3.81|0.0819
72597560|NCT00938587|144726834|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.15|STANDARD_ERROR_OF_MEAN|1.106||0.8892|TWO_SIDED|90.0|-1.98|1.67|||MMRM|||Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||1.67|-1.98|0.8892
72597561|NCT00938587|144726834|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-2.35|STANDARD_ERROR_OF_MEAN|1.106||0.0353|TWO_SIDED|90.0|-4.17|-0.52|||MMRM|||Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||-0.52|-4.17|0.0353
72597562|NCT00938587|144726834|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.39|STANDARD_ERROR_OF_MEAN|1.108||0.7283|TWO_SIDED|90.0|-2.22|1.45|||MMRM|||Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||1.45|-2.22|0.7283
72597563|NCT00938587|144726834|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.14|STANDARD_ERROR_OF_MEAN|1.174||0.9083|TWO_SIDED|90.0|-1.81|2.08|||MMRM|||Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||2.08|-1.81|0.9083
72597564|NCT00938587|144726834|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.58|STANDARD_ERROR_OF_MEAN|1.132||0.1641|TWO_SIDED|90.0|-3.45|0.29|||MMRM|||Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||0.29|-3.45|0.1641
72597565|NCT00938587|144726834|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.27|STANDARD_ERROR_OF_MEAN|1.155||0.817|TWO_SIDED|90.0|-1.64|2.18|||MMRM|||Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||2.18|-1.64|0.8170
72597566|NCT00938587|144726834|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.45|STANDARD_ERROR_OF_MEAN|1.116||0.1958|TWO_SIDED|90.0|-3.29|0.4|||MMRM|||Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||0.40|-3.29|0.1958
72597567|NCT00938587|144726834|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.13|STANDARD_ERROR_OF_MEAN|1.13||0.907|TWO_SIDED|90.0|-1.74|2.0|||MMRM|||Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||2.00|-1.74|0.9070
72597568|NCT00938587|144726834|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|3.58|STANDARD_ERROR_OF_MEAN|1.16||0.0023|TWO_SIDED|90.0|1.67|5.5|||MMRM|||Day 42: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||5.50|1.67|0.0023
72415733|NCT03336619|144342353|SUPERIORITY|||||||0.3765|||||||Gehan-Wilcoxon|Analysis used a Gehan-Wilcoxon test stratified by time from symptom onset at enrollment and influenza vaccination status.||||||0.3765
72415734|NCT03336619|144342354|SUPERIORITY|||||||0.6331|||||||Gehan-Wilcoxon|Gehan-Wilcoxon test stratified by time from symptom onset at enrollment and influenza vaccination status.||||||0.6331
72415735|NCT03336619|144342355|SUPERIORITY|||||||0.7382|||||||Fisher Exact|||||||0.7382
72597569|NCT00938587|144726834|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.62|STANDARD_ERROR_OF_MEAN|1.132||0.1531|TWO_SIDED|90.0|-0.25|3.49|||MMRM|||Day 42: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||3.49|-0.25|0.1531
72597570|NCT00938587|144726834|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.65|STANDARD_ERROR_OF_MEAN|1.141||0.1506|TWO_SIDED|90.0|-0.24|3.53|||MMRM|||Day 42: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||3.53|-0.24|0.1506
72597571|NCT00938587|144726834|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.31|STANDARD_ERROR_OF_MEAN|1.116||0.78|TWO_SIDED|90.0|-2.16|1.53|||MMRM|||Day 42: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||1.53|-2.16|0.7800
72597572|NCT00938587|144726834|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.94|STANDARD_ERROR_OF_MEAN|1.13||0.0883|TWO_SIDED|90.0|-3.8|-0.07|||MMRM|||Day 42: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||-0.07|-3.80|0.0883
72597573|NCT00938587|144726835|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-8.47|STANDARD_ERROR_OF_MEAN|4.48||0.0599|TWO_SIDED|90.0|-15.87|-1.07|||MMRM|||Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||-1.07|-15.87|0.0599
72415736|NCT03336619|144342356|SUPERIORITY|||||||0.3236|||||||Gehan-Wilcoxon|Gehan-Wilcoxon test stratified by time from symptom onset to enrollment and influenza vaccination status.||||||0.3236
72597574|NCT00938587|144726835|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-13.29|STANDARD_ERROR_OF_MEAN|4.436||0.003|TWO_SIDED|90.0|-20.61|-5.96|||MMRM|||Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||-5.96|-20.61|0.0030
72597575|NCT00938587|144726835|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-12.63|STANDARD_ERROR_OF_MEAN|4.483||0.0053|TWO_SIDED|90.0|-20.03|-5.22|||MMRM|||Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||-5.22|-20.03|0.0053
72597576|NCT00938587|144726835|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-17.44|STANDARD_ERROR_OF_MEAN|4.445||0.0001|TWO_SIDED|90.0|-24.78|-10.1|||MMRM|||Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||-10.10|-24.78|0.0001
72597577|NCT00938587|144726835|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-4.15|STANDARD_ERROR_OF_MEAN|4.427||0.3492|TWO_SIDED|90.0|-11.46|3.16|||MMRM|||Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||3.16|-11.46|0.3492
72597578|NCT00938587|144726835|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-9.68|STANDARD_ERROR_OF_MEAN|4.661||0.0389|TWO_SIDED|90.0|-17.38|-1.98|||MMRM|||Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure||-1.98|-17.38|0.0389
72597579|NCT00938587|144726835|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-11.1|STANDARD_ERROR_OF_MEAN|4.49||0.0142|TWO_SIDED|90.0|-18.51|-3.68|||MMRM|||Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||-3.68|-18.51|0.0142
72597580|NCT00938587|144726835|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-13.51|STANDARD_ERROR_OF_MEAN|4.612||0.0037|TWO_SIDED|90.0|-21.13|-5.89|||MMRM|||Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||-5.89|-21.13|0.0037
72597581|NCT00938587|144726835|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-14.93|STANDARD_ERROR_OF_MEAN|4.447||0.0009|TWO_SIDED|90.0|-22.27|-7.58|||MMRM|||Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||-7.58|-22.27|0.0009
72597582|NCT00938587|144726835|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-3.83|STANDARD_ERROR_OF_MEAN|4.484||0.3939|TWO_SIDED|90.0|-11.23|3.57|||MMRM|||Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||3.57|-11.23|0.3939
72597583|NCT00938587|144726835|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|11.54|STANDARD_ERROR_OF_MEAN|4.595||0.0127|TWO_SIDED|90.0|3.95|19.13|||MMRM|||Day 42: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||19.13|3.95|0.0127
72597584|NCT00938587|144726835|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.32|STANDARD_ERROR_OF_MEAN|4.49||0.9425|TWO_SIDED|90.0|-7.09|7.74|||MMRM|||Day 42: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||7.74|-7.09|0.9425
72597585|NCT00938587|144726835|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|11.08|STANDARD_ERROR_OF_MEAN|4.544||0.0155|TWO_SIDED|90.0|3.58|18.59|||MMRM|||Day 42: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||18.59|3.58|0.0155
72597586|NCT00938587|144726835|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.14|STANDARD_ERROR_OF_MEAN|4.447||0.9757|TWO_SIDED|90.0|-7.48|7.21|||MMRM|||Day 42: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||7.21|-7.48|0.9757
72597587|NCT00938587|144726835|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.46|STANDARD_ERROR_OF_MEAN|4.484||0.9184|TWO_SIDED|90.0|-7.86|6.94|||MMRM|||Day 42: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||6.94|-7.86|0.9184
72597588|NCT00938587|144726836|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.16|STANDARD_ERROR_OF_MEAN|0.135||0.2403|TWO_SIDED|90.0|-0.38|0.06|||MMRM|||Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||0.06|-0.38|0.2403
72597589|NCT00938587|144726836|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.134||0.027|TWO_SIDED|90.0|-0.52|-0.08|||MMRM|||Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||-0.08|-0.52|0.0270
72415737|NCT03336619|144342357|SUPERIORITY|||||||0.0483|||||||Gehan-Wilcoxon|Gehan-Wilcoxon test stratified by time from symptom onset at enrollment and influenza vaccination status.||||||0.0483
72415738|NCT02474927|144342403|OTHER|Descriptive (Pre-Post)||||||0.36|||||||Wilcoxon Signed Rank|||||||0.36
72597590|NCT00938587|144726836|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.13|STANDARD_ERROR_OF_MEAN|0.133||0.3139|TWO_SIDED|90.0|-0.36|0.09|||MMRM|||Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||0.09|-0.36|0.3139
72597591|NCT00938587|144726836|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.28|STANDARD_ERROR_OF_MEAN|0.134||0.0415|TWO_SIDED|90.0|-0.5|-0.05|||MMRM|||Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||-0.05|-0.50|0.0415
72597592|NCT00938587|144726836|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.02|STANDARD_ERROR_OF_MEAN|0.134||0.8585|TWO_SIDED|90.0|-0.2|0.25|||MMRM|||Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||0.25|-0.20|0.8585
72597593|NCT00938587|144726836|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.05|STANDARD_ERROR_OF_MEAN|0.138||0.7284|TWO_SIDED|90.0|-0.28|0.18|||MMRM|||Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||0.18|-0.28|0.7284
72597594|NCT00938587|144726836|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.33|STANDARD_ERROR_OF_MEAN|0.135||0.0171|TWO_SIDED|90.0|-0.55|-0.1|||MMRM|||Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||-0.10|-0.55|0.0171
72597595|NCT00938587|144726836|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.16|STANDARD_ERROR_OF_MEAN|0.135||0.2277|TWO_SIDED|90.0|-0.39|0.06|||MMRM|||Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||0.06|-0.39|0.2277
72597596|NCT00938587|144726836|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.44|STANDARD_ERROR_OF_MEAN|0.134||0.0013|TWO_SIDED|90.0|-0.67|-0.22|||MMRM|||Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||-0.22|-0.67|0.0013
72597597|NCT00938587|144726836|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.12|STANDARD_ERROR_OF_MEAN|0.135||0.3908|TWO_SIDED|90.0|-0.34|0.11|||MMRM|||Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||0.11|-0.34|0.3908
72597598|NCT00938587|144726837|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-3.66|STANDARD_ERROR_OF_MEAN|7.093||0.6067|TWO_SIDED|90.0|-15.43|8.1|||MMRM|||Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||8.10|-15.43|0.6067
72597599|NCT00938587|144726837|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-9.55|STANDARD_ERROR_OF_MEAN|7.101||0.1816|TWO_SIDED|90.0|-21.32|2.23|||MMRM|||Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||2.23|-21.32|0.1816
72597600|NCT00938587|144726837|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-2.84|STANDARD_ERROR_OF_MEAN|7.029||0.6873|TWO_SIDED|90.0|-14.5|8.82|||MMRM|||Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||8.82|-14.50|0.6873
72597601|NCT00938587|144726837|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-8.72|STANDARD_ERROR_OF_MEAN|7.052||0.2188|TWO_SIDED|90.0|-20.42|2.98|||MMRM|||Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||2.98|-20.42|0.2188
72597602|NCT00938587|144726837|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.83|STANDARD_ERROR_OF_MEAN|7.024||0.9067|TWO_SIDED|90.0|-10.82|12.47|||MMRM|||Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||12.47|-10.82|0.9067
72597603|NCT00938587|144726837|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-4.02|STANDARD_ERROR_OF_MEAN|7.254||0.5803|TWO_SIDED|90.0|-16.05|8.0|||MMRM|||Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||8.00|-16.05|0.5803
72415739|NCT02474927|144342404|OTHER|Descriptive (pre-post)||||||0.16|||||||Wilcoxon Signed Rank|||||||0.16
72597604|NCT00938587|144726837|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-8.29|STANDARD_ERROR_OF_MEAN|7.156||0.249|TWO_SIDED|90.0|-20.16|3.57|||MMRM|||Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||3.57|-20.16|0.2490
72415740|NCT01371851|144342414|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.0529||||0.05|TWO_SIDED||||||Regression, Logistic|||The analysis was applied to urine data obtained at all time points during weeks 1-8.||||0.05
72597605|NCT00938587|144726837|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-11.62|STANDARD_ERROR_OF_MEAN|7.178||0.1081|TWO_SIDED|90.0|-23.52|0.28|||MMRM|||Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||0.28|-23.52|0.1081
72597606|NCT00938587|144726837|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-15.89|STANDARD_ERROR_OF_MEAN|7.098||0.0271|TWO_SIDED|90.0|-27.66|-4.12|||MMRM|||Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||-4.12|-27.66|0.0271
72597607|NCT00938587|144726837|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-7.6|STANDARD_ERROR_OF_MEAN|7.121||0.2881|TWO_SIDED|90.0|-19.41|4.21|||MMRM|||Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||4.21|-19.41|0.2881
72597608|NCT00938587|144726838|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-6.52|STANDARD_ERROR_OF_MEAN|7.059||0.3579|TWO_SIDED|90.0|-18.23|5.19|||MMRM|||Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||5.19|-18.23|0.3579
72597609|NCT00938587|144726838|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-8.55|STANDARD_ERROR_OF_MEAN|7.046||0.2274|TWO_SIDED|90.0|-20.24|3.14|||MMRM|||Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||3.14|-20.24|0.2274
72597610|NCT00938587|144726838|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-10.15|STANDARD_ERROR_OF_MEAN|6.973||0.1482|TWO_SIDED|90.0|-21.72|1.41|||MMRM|||Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||1.41|-21.72|0.1482
72597611|NCT00938587|144726838|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-12.19|STANDARD_ERROR_OF_MEAN|6.962||0.0828|TWO_SIDED|90.0|-23.74|-0.64|||MMRM|||Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||-0.64|-23.74|0.0828
72597612|NCT00938587|144726838|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-3.64|STANDARD_ERROR_OF_MEAN|6.953||0.6021|TWO_SIDED|90.0|-15.17|7.9|||MMRM|||Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||7.90|-15.17|0.6021
72597613|NCT00938587|144726838|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-2.28|STANDARD_ERROR_OF_MEAN|7.213||0.7528|TWO_SIDED|90.0|-14.24|9.68|||MMRM|||Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||9.68|-14.24|0.7528
72421607|NCT03720938|144354382|SUPERIORITY|||||||55||||||Linear mixed-effects model fit by maximum likelihood since restricted maximum likelihood assumes a strong normality.|Linear mixed-effects model|Adjusted by Satterthwaite's degrees of freedom method for cluster effect, and small sample sizes in addition to baseline value and age.||Null hypothesis was the absence of difference between the two groups for the dependent variable visual reaction time of non-dominant hand.||||000000055
72597614|NCT00938587|144726838|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-8.17|STANDARD_ERROR_OF_MEAN|7.1||0.2523|TWO_SIDED|90.0|-19.94|3.6|||MMRM|||Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||3.60|-19.94|0.2523
72597615|NCT00938587|144726838|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-11.63|STANDARD_ERROR_OF_MEAN|7.118||0.1049|TWO_SIDED|90.0|-23.43|0.17|||MMRM|||Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||0.17|-23.43|0.1049
72597616|NCT00938587|144726838|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-17.53|STANDARD_ERROR_OF_MEAN|7.006||0.0138|TWO_SIDED|90.0|-29.14|-5.91|||MMRM|||Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||-5.91|-29.14|0.0138
72597617|NCT00938587|144726838|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-9.36|STANDARD_ERROR_OF_MEAN|7.052||0.1873|TWO_SIDED|90.0|-21.05|2.34|||MMRM|||Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||2.34|-21.05|0.1873
72597618|NCT00938587|144726839|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-3.54|STANDARD_ERROR_OF_MEAN|5.339||0.509|TWO_SIDED|90.0|-12.4|5.32|||MMRM|||Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||5.32|-12.40|0.5090
72415741|NCT00833638|144342415|SUPERIORITY_OR_OTHER|||||||0.086||95.0||||P-value for day \<=4. A fixed-sequence test was used within each dose group at each time point (days 4, 3, 2, 1) and adjusted for multiple dose-placebo comparisons using the Bonferroni method. Testing started on day 4 and stopped when p\>.025.|Regression, Logistic|Model response = treatment + pooled site + severity of erectile dysfunction at baseline.||The null-hypothesis was tested that there is no statistically significant difference in the onset of efficacy between tadalafil 2.5 mg and placebo as determined by the earliest day on which the cumulative percentage of subjects achieving at least 1 successful intercourse (within 4 days of starting treatment) is statistically significantly different between active drug and placebo.||||0.086
72415742|NCT00833638|144342415|SUPERIORITY_OR_OTHER|||||||0.006||95.0||||P-value for day \<=4. A fixed-sequence test was used within each dose group at each time point (days 4, 3, 2, 1) and adjusted for multiple dose-placebo comparisons using the Bonferroni method. Testing started on day 4 and stopped when p\>.025.|Regression, Logistic|Model response = treatment + pooled site + severity of erectile dysfunction at baseline.||The null-hypothesis was tested that there is no statistically significant difference in the onset of efficacy between tadalafil 5 mg and placebo as determined by the earliest day on which the cumulative percentage of participants achieving at least 1 successful intercourse (within 4 days of starting treatment) is statistically significantly different between active drug and placebo.||||0.006
72415743|NCT00833638|144342415|SUPERIORITY_OR_OTHER|||||||0.019||95.0||||P-value for day \<=3. A fixed-sequence test was used within each dose group at each time point (days 4, 3, 2, 1) and adjusted for multiple dose-placebo comparisons using the Bonferroni method. Testing started on day 4 and stopped when p\>.025.|Regression, Logistic|Model response = treatment + pooled site + severity of erectile dysfunction at baseline.||The null-hypothesis was tested that there is no statistically significant difference in the onset of efficacy between tadalafil 5 mg and placebo as determined by the earliest day on which the cumulative percentage of participants achieving at least 1 successful intercourse (within 4 days of starting treatment) is statistically significantly different between active drug and placebo.||||0.019
72415744|NCT00833638|144342415|SUPERIORITY_OR_OTHER|||||||0.022||95.0||||P-value for day \<=2. A fixed-sequence test was used within each dose group at each time point (days 4, 3, 2, 1) and adjusted for multiple dose-placebo comparisons using the Bonferroni method. Testing started on day 4 and stopped when p\>.025.|Regression, Logistic|Model response = treatment + pooled site + severity of erectile dysfunction at baseline.||The null-hypothesis was tested that there is no statistically significant difference in the onset of efficacy between tadalafil 5 mg and placebo as determined by the earliest day on which the cumulative percentage of participants achieving at least 1 successful intercourse (within 4 days of starting treatment) is statistically significantly different between active drug and placebo.||||0.022
72421608|NCT03720938|144354383|SUPERIORITY|||||||0||||||The outcomes of auditory reaction time of dominant hand was tested for any difference between groups by covariate analysis.|ANCOVA|Adjusted for the auditory reaction time of dominant hand at baseline and confounding variable age.||Null hypothesis was the absence of difference between the two groups for the dependent variable auditory reaction time of dominant hand.||||0.000
72597619|NCT00938587|144726839|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-8.89|STANDARD_ERROR_OF_MEAN|5.354||0.0998|TWO_SIDED|90.0|-17.78|-0.01|||MMRM|||Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||-0.01|-17.78|0.0998
72597620|NCT00938587|144726839|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.76|STANDARD_ERROR_OF_MEAN|5.282||0.8866|TWO_SIDED|90.0|-9.52|8.01|||MMRM|||Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||8.01|-9.52|0.8866
72597621|NCT00938587|144726839|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-6.11|STANDARD_ERROR_OF_MEAN|5.28||0.2499|TWO_SIDED|90.0|-14.88|2.66|||MMRM|||Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||2.66|-14.88|0.2499
72597622|NCT00938587|144726839|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|2.78|STANDARD_ERROR_OF_MEAN|5.283||0.5995|TWO_SIDED|90.0|-5.99|11.55|||MMRM|||Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||11.55|-5.99|0.5995
72597623|NCT00938587|144726839|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.6|STANDARD_ERROR_OF_MEAN|5.429||0.9117|TWO_SIDED|90.0|-8.4|9.61|||MMRM|||Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||9.61|-8.40|0.9117
72597624|NCT00938587|144726839|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-9.91|STANDARD_ERROR_OF_MEAN|5.381||0.0684|TWO_SIDED|90.0|-18.84|-0.98|||MMRM|||Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||-0.98|-18.84|0.0684
72597625|NCT00938587|144726839|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-6.49|STANDARD_ERROR_OF_MEAN|5.366||0.2292|TWO_SIDED|90.0|-15.39|2.42|||MMRM|||Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||2.42|-15.39|0.2292
72597626|NCT00938587|144726839|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-17.0|STANDARD_ERROR_OF_MEAN|5.308||0.0018|TWO_SIDED|90.0|-25.81|-8.19|||MMRM|||Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||-8.19|-25.81|0.0018
72597627|NCT00938587|144726839|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-7.09|STANDARD_ERROR_OF_MEAN|5.337||0.1867|TWO_SIDED|90.0|-15.95|1.76|||MMRM|||Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||1.76|-15.95|0.1867
72597628|NCT00938587|144726840|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.13|STANDARD_ERROR_OF_MEAN|2.708||0.9624|TWO_SIDED|90.0|-4.64|4.38|||ANCOVA|||Physical functioning at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using analysis of covariance (ANCOVA) where treatment as fixed effect, baseline as the covariate.||4.38|-4.64|0.9624
72597629|NCT00938587|144726840|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.17|STANDARD_ERROR_OF_MEAN|2.65||0.9493|TWO_SIDED|90.0|-4.24|4.58|||ANCOVA|||Physical functioning at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.||4.58|-4.24|0.9493
72597630|NCT00938587|144726840|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|3.46|STANDARD_ERROR_OF_MEAN|2.738||0.21|TWO_SIDED|90.0|-1.1|8.02|||ANCOVA|||Physical functioning at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.||8.02|-1.10|0.2100
72597631|NCT00938587|144726840|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|3.76|STANDARD_ERROR_OF_MEAN|2.651||0.1602|TWO_SIDED|90.0|-0.66|8.18|||ANCOVA|||Physical functioning at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.||8.18|-0.66|0.1602
72597632|NCT00938587|144726840|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|3.59|STANDARD_ERROR_OF_MEAN|2.71||0.1892|TWO_SIDED|90.0|-0.92|8.1|||ANCOVA|||Physical functioning at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.||8.10|-0.92|0.1892
72597633|NCT00938587|144726840|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.74|STANDARD_ERROR_OF_MEAN|2.781||0.7899|TWO_SIDED|90.0|-3.89|5.38|||ANCOVA|||Role physical at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.||5.38|-3.89|0.7899
72597634|NCT00938587|144726840|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|3.96|STANDARD_ERROR_OF_MEAN|2.719||0.149|TWO_SIDED|90.0|-0.56|8.49|||ANCOVA|||Role physical at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.||8.49|-0.56|0.1490
72597635|NCT00938587|144726840|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.36|STANDARD_ERROR_OF_MEAN|2.766||0.6238|TWO_SIDED|90.0|-5.97|3.24|||ANCOVA|||Role physical at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.||3.24|-5.97|0.6238
72597636|NCT00938587|144726840|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.86|STANDARD_ERROR_OF_MEAN|2.699||0.4933|TWO_SIDED|90.0|-2.64|6.35|||ANCOVA|||Role physical at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.||6.35|-2.64|0.4933
72597637|NCT00938587|144726840|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-2.11|STANDARD_ERROR_OF_MEAN|2.739||0.4445|TWO_SIDED|90.0|-6.67|2.46|||ANCOVA|||Role physical at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.||2.46|-6.67|0.4445
72597638|NCT00938587|144726840|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|3.51|STANDARD_ERROR_OF_MEAN|2.897||0.2288|TWO_SIDED|90.0|-1.31|8.34|||ANCOVA|||Bodily pain at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.||8.34|-1.31|0.2288
72597639|NCT00938587|144726840|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|4.77|STANDARD_ERROR_OF_MEAN|2.844||0.098|TWO_SIDED|90.0|0.03|9.5|||ANCOVA|||Bodily pain at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate||9.50|0.03|0.0980
72597640|NCT00938587|144726840|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|5.54|STANDARD_ERROR_OF_MEAN|2.941||0.0637|TWO_SIDED|90.0|0.64|10.43|||ANCOVA|||Bodily pain at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate||10.43|0.64|0.0637
72597641|NCT00938587|144726840|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|6.79|STANDARD_ERROR_OF_MEAN|2.831||0.019|TWO_SIDED|90.0|2.07|11.5|||ANCOVA|||Bodily pain at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.||11.50|2.07|0.0190
72597642|NCT00938587|144726840|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|2.02|STANDARD_ERROR_OF_MEAN|2.903||0.4886|TWO_SIDED|90.0|-2.81|6.86|||ANCOVA|||Bodily pain at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.||6.86|-2.81|0.4886
72597643|NCT00938587|144726840|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.01|STANDARD_ERROR_OF_MEAN|1.879||0.9951|TWO_SIDED|90.0|-3.12|3.14|||ANCOVA|||General health at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.||3.14|-3.12|0.9951
72597644|NCT00938587|144726840|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.31|STANDARD_ERROR_OF_MEAN|1.818||0.4721|TWO_SIDED|90.0|-1.71|4.34|||ANCOVA|||General health at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.||4.34|-1.71|0.4721
72597645|NCT00938587|144726840|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.77|STANDARD_ERROR_OF_MEAN|1.879||0.6835|TWO_SIDED|90.0|-3.9|2.36|||ANCOVA|||General health at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.||2.36|-3.90|0.6835
72597646|NCT00938587|144726840|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.53|STANDARD_ERROR_OF_MEAN|1.818||0.7701|TWO_SIDED|90.0|-2.49|3.56|||ANCOVA|||General health at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.||3.56|-2.49|0.7701
72597647|NCT00938587|144726840|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.78|STANDARD_ERROR_OF_MEAN|1.831||0.671|TWO_SIDED|90.0|-3.83|2.27|||ANCOVA|||General health at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.||2.27|-3.83|0.6710
72597648|NCT00938587|144726840|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|3.02|STANDARD_ERROR_OF_MEAN|2.827||0.2886|TWO_SIDED|90.0|-1.69|7.73|||ANCOVA|||Vitality at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.||7.73|-1.69|0.2886
72597649|NCT00938587|144726840|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|4.22|STANDARD_ERROR_OF_MEAN|2.784||0.134|TWO_SIDED|90.0|-0.42|8.86|||ANCOVA|||Vitality at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.||8.86|-0.42|0.1340
72597650|NCT00938587|144726840|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|3.24|STANDARD_ERROR_OF_MEAN|2.83||0.2563|TWO_SIDED|90.0|-1.48|7.95|||ANCOVA|||Vitality at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.||7.95|-1.48|0.2563
72597651|NCT00938587|144726840|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|4.43|STANDARD_ERROR_OF_MEAN|2.771||0.1138|TWO_SIDED|90.0|-0.18|9.05|||ANCOVA|||Vitality at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.||9.05|-0.18|0.1138
72597652|NCT00938587|144726840|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.22|STANDARD_ERROR_OF_MEAN|2.793||0.9386|TWO_SIDED|90.0|-4.44|4.87|||ANCOVA|||Vitality at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.||4.87|-4.44|0.9386
72597653|NCT00938587|144726840|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.4|STANDARD_ERROR_OF_MEAN|2.701||0.8814|TWO_SIDED|90.0|-4.09|4.9|||ANCOVA|||Social functioning at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.||4.90|-4.09|0.8814
72597654|NCT00938587|144726840|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|3.98|STANDARD_ERROR_OF_MEAN|2.64||0.1363|TWO_SIDED|90.0|-0.42|8.37|||ANCOVA|||Social functioning at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.||8.37|-0.42|0.1363
72597655|NCT00938587|144726840|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.73|STANDARD_ERROR_OF_MEAN|2.682||0.7864|TWO_SIDED|90.0|-3.74|5.2|||ANCOVA|||Social functioning at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.||5.20|-3.74|0.7864
72597656|NCT00938587|144726840|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|4.3|STANDARD_ERROR_OF_MEAN|2.619||0.1048|TWO_SIDED|90.0|-0.06|8.66|||ANCOVA|||Social functioning at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.||8.66|-0.06|0.1048
72597657|NCT00938587|144726840|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.33|STANDARD_ERROR_OF_MEAN|2.643||0.9024|TWO_SIDED|90.0|-4.08|4.73|||ANCOVA|||Social functioning at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.||4.73|-4.08|0.9024
72597658|NCT00938587|144726840|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|2.62|STANDARD_ERROR_OF_MEAN|3.819||0.4954|TWO_SIDED|90.0|-3.74|8.98|||ANCOVA|||Role emotional at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.||8.98|-3.74|0.4954
72597659|NCT00938587|144726840|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|5.14|STANDARD_ERROR_OF_MEAN|3.735||0.1729|TWO_SIDED|90.0|-1.08|11.36|||ANCOVA|||Role emotional at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.||11.36|-1.08|0.1729
72597660|NCT00938587|144726840|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|2.21|STANDARD_ERROR_OF_MEAN|3.82||0.565|TWO_SIDED|90.0|-4.15|8.57|||ANCOVA|||Role emotional at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.||8.57|-4.15|0.5650
72597661|NCT00938587|144726840|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|4.73|STANDARD_ERROR_OF_MEAN|3.73||0.2087|TWO_SIDED|90.0|-1.48|10.94|||ANCOVA|||Role emotional at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.||10.94|-1.48|0.2087
72597662|NCT00938587|144726840|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.41|STANDARD_ERROR_OF_MEAN|3.771||0.9139|TWO_SIDED|90.0|-6.69|5.87|||ANCOVA|||Role emotional at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.||5.87|-6.69|0.9139
72597663|NCT00938587|144726840|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.51|STANDARD_ERROR_OF_MEAN|3.371||0.6559|TWO_SIDED|90.0|-4.11|7.12|||ANCOVA|||Mental health at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.||7.12|-4.11|0.6559
72597664|NCT00938587|144726840|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.15|STANDARD_ERROR_OF_MEAN|3.315||0.7304|TWO_SIDED|90.0|-4.37|6.67|||ANCOVA|||Mental health at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.||6.67|-4.37|0.7304
72597665|NCT00938587|144726840|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|4.64|STANDARD_ERROR_OF_MEAN|3.369||0.1729|TWO_SIDED|90.0|-0.98|10.25|||ANCOVA|||Mental health at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.||10.25|-0.98|0.1729
72597666|NCT00938587|144726840|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|4.27|STANDARD_ERROR_OF_MEAN|3.335||0.2038|TWO_SIDED|90.0|-1.28|9.83|||ANCOVA|||Mental health at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.||9.83|-1.28|0.2038
72597667|NCT00938587|144726840|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|3.13|STANDARD_ERROR_OF_MEAN|3.328||0.3503|TWO_SIDED|90.0|-2.41|8.67|||ANCOVA|||Mental health at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.||8.67|-2.41|0.3503
72597668|NCT00938587|144726840|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.29|STANDARD_ERROR_OF_MEAN|2.01||0.8875|TWO_SIDED|90.0|-3.06|3.63|||ANCOVA|||Physical component at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.||3.63|-3.06|0.8875
72597669|NCT00938587|144726840|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.97|STANDARD_ERROR_OF_MEAN|1.971||0.3203|TWO_SIDED|90.0|-1.31|5.25|||ANCOVA|||Physical component at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.||5.25|-1.31|0.3203
72597670|NCT00938587|144726840|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.31|STANDARD_ERROR_OF_MEAN|2.046||0.5232|TWO_SIDED|90.0|-2.09|4.72|||ANCOVA|||Physical component at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.||4.72|-2.09|0.5232
72597671|NCT00938587|144726840|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|3.0|STANDARD_ERROR_OF_MEAN|1.971||0.1324|TWO_SIDED|90.0|-0.28|6.28|||ANCOVA|||Physical component at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.||6.28|-0.28|0.1324
72597672|NCT00938587|144726840|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.03|STANDARD_ERROR_OF_MEAN|2.024||0.6134|TWO_SIDED|90.0|-2.34|4.4|||ANCOVA|||Physical component at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.||4.40|-2.34|0.6134
72597673|NCT00938587|144726840|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|2.26|STANDARD_ERROR_OF_MEAN|3.387||0.5059|TWO_SIDED|90.0|-3.38|7.91|||ANCOVA|||Mental component at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.||7.91|-3.38|0.5059
72597674|NCT00938587|144726840|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|3.44|STANDARD_ERROR_OF_MEAN|3.329||0.3042|TWO_SIDED|90.0|-2.1|8.99|||ANCOVA|||Mental component at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.||8.99|-2.10|0.3042
72597675|NCT00938587|144726840|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|3.18|STANDARD_ERROR_OF_MEAN|3.39||0.3519|TWO_SIDED|90.0|-2.47|8.82|||ANCOVA|||Mental component at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.||8.82|-2.47|0.3519
72597676|NCT00938587|144726840|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|4.36|STANDARD_ERROR_OF_MEAN|3.342||0.1966|TWO_SIDED|90.0|-1.21|9.92|||ANCOVA|||Mental component at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.||9.92|-1.21|0.1966
72597677|NCT00938587|144726840|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.91|STANDARD_ERROR_OF_MEAN|3.345||0.786|TWO_SIDED|90.0|-4.66|6.48|||ANCOVA|||Mental component at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.||6.48|-4.66|0.7860
72597678|NCT00938587|144726841|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.46|STANDARD_ERROR_OF_MEAN|0.286||0.109|TWO_SIDED|90.0|-0.93|0.01|||MMRM|||Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||0.01|-0.93|0.1090
72597679|NCT00938587|144726841|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.91|STANDARD_ERROR_OF_MEAN|0.282||0.0014|TWO_SIDED|90.0|-1.38|-0.45|||MMRM|||Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||-0.45|-1.38|0.0014
72597680|NCT00938587|144726841|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.56|STANDARD_ERROR_OF_MEAN|0.284||0.0506|TWO_SIDED|90.0|-1.03|-0.09|||MMRM|||Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||-0.09|-1.03|0.0506
72597681|NCT00938587|144726841|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.01|STANDARD_ERROR_OF_MEAN|0.28||0.0004|TWO_SIDED|90.0|-1.48|-0.55|||MMRM|||Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||-0.55|-1.48|0.0004
72597682|NCT00938587|144726841|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.281||0.7272|TWO_SIDED|90.0|-0.56|0.37|||MMRM|||Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||0.37|-0.56|0.7272
72597683|NCT00938587|144726841|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.56|STANDARD_ERROR_OF_MEAN|0.296||0.0604|TWO_SIDED|90.0|-1.05|-0.07|||MMRM|||Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||-0.07|-1.05|0.0604
72597684|NCT00938587|144726841|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.06|STANDARD_ERROR_OF_MEAN|0.285||0.0003|TWO_SIDED|90.0|-1.53|-0.59|||MMRM|||Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||-0.59|-1.53|0.0003
72597685|NCT00938587|144726841|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.61|STANDARD_ERROR_OF_MEAN|0.291||0.0377|TWO_SIDED|90.0|-1.09|-0.13|||MMRM|||Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||-0.13|-1.09|0.0377
72597686|NCT00938587|144726841|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.11|STANDARD_ERROR_OF_MEAN|0.28||0.0001|TWO_SIDED|90.0|-1.57|-0.65|||MMRM|||Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||-0.65|-1.57|0.0001
72597687|NCT00938587|144726841|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.05|STANDARD_ERROR_OF_MEAN|0.284||0.8612|TWO_SIDED|90.0|-0.52|0.42|||MMRM|||Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||0.42|-0.52|0.8612
72597688|NCT00938587|144726841|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.44|STANDARD_ERROR_OF_MEAN|0.292||0.133|TWO_SIDED|90.0|-0.04|0.93|||MMRM|||Day 42: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||0.93|-0.04|0.1330
72597689|NCT00938587|144726841|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.05|STANDARD_ERROR_OF_MEAN|0.285||0.8542|TWO_SIDED|90.0|-0.52|0.42|||MMRM|||Day 42: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||0.42|-0.52|0.8542
72597690|NCT00938587|144726841|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.34|STANDARD_ERROR_OF_MEAN|0.288||0.2339|TWO_SIDED|90.0|-0.13|0.82|||MMRM|||Day 42: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||0.82|-0.13|0.2339
72597691|NCT00938587|144726841|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.15|STANDARD_ERROR_OF_MEAN|0.28||0.5927|TWO_SIDED|90.0|-0.61|0.31|||MMRM|||Day 42: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||0.31|-0.61|0.5927
72597692|NCT00938587|144726841|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.284||0.7304|TWO_SIDED|90.0|-0.57|0.37|||MMRM|||Day 42: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||0.37|-0.57|0.7304
72597693|NCT00938587|144726842|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.49|STANDARD_ERROR_OF_MEAN|0.29||0.0956|TWO_SIDED|90.0|-0.97|-0.01|||MMRM|||Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||-0.01|-0.97|0.0956
72597694|NCT00938587|144726842|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.93|STANDARD_ERROR_OF_MEAN|0.286||0.0016|TWO_SIDED|90.0|-1.4|-0.45|||MMRM|||Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||-0.45|-1.40|0.0016
72597695|NCT00938587|144726842|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.65|STANDARD_ERROR_OF_MEAN|0.287||0.0258|TWO_SIDED|90.0|-1.13|-0.17|||MMRM|||Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||-0.17|-1.13|0.0258
72597696|NCT00938587|144726842|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.09|STANDARD_ERROR_OF_MEAN|0.283||0.0002|TWO_SIDED|90.0|-1.56|-0.62|||MMRM|||Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||-0.62|-1.56|0.0002
72597697|NCT00938587|144726842|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.16|STANDARD_ERROR_OF_MEAN|0.284||0.5692||90.0|-0.63|0.31|||MMRM|||Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||0.31|-0.63|0.5692
72597698|NCT00938587|144726843|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|14.29||||0.146|TWO_SIDED|90.0|-8.65|35.98|||Barnard exact test|||Day 7||35.98|-8.65|0.1460
72597699|NCT00938587|144726843|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|38.1||||0.0052|TWO_SIDED|90.0|12.25|59.46|||Barnard exact test|||Day 7||59.46|12.25|0.0052
72597700|NCT00938587|144726843|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|1.3||||0.5094|TWO_SIDED|90.0|-22.0|24.66|||Barnard exact test|||Day 7||24.66|-22.00|0.5094
72415745|NCT00833638|144342415|SUPERIORITY_OR_OTHER|||||||0.573||95.0||||P-value for day \<=1. A fixed-sequence test was used within each dose group at each time point (days 4, 3, 2, 1) and adjusted for multiple dose-placebo comparisons using the Bonferroni method. Testing started on day 4 and stopped when p\>.025.|Regression, Logistic|||The null-hypothesis was tested that there is no statistically significant difference in the onset of efficacy between tadalafil 5 mg and placebo as determined by the earliest day on which the cumulative percentage of participants achieving at least 1 successful intercourse (within 4 days of starting treatment) is statistically significantly different between active drug and placebo.||||0.573
72415746|NCT00833638|144342416|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.03|||<|0.001|TWO_SIDED|95.0|5.72|18.34||No adjustment for multiplicity.|ANCOVA|Included were terms for baseline value of the efficacy variable, treatment, site, and the baseline-by-treatment interaction were included.||"Tested was the null-hypothesis that no differences in the percentages of participants who answered yes to the sexual encounter profile diary question number 1 exist between participants who received placebo and participants who received tadalafil 2.5 mg."||18.34|5.72|<0.001
72597701|NCT00938587|144726843|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|25.11||||0.0551|TWO_SIDED|90.0|-0.69|48.34|||Barnard exact test|||Day 7||48.34|-0.69|0.0551
72421609|NCT03720938|144354383|SUPERIORITY|||||||1.633e-05||||||The outcomes of auditory reaction time of dominant hand was tested for any difference between groups by linear mixed-effects analysis.|Linear mixed-effects model|Adjusted for cluster effect in addition to baseline value and age.||Null hypothesis was the absence of difference between the two groups for the dependent variable auditory reaction time of dominant hand.||||0.00001633
72597702|NCT00938587|144726843|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|-12.99||||0.9999|TWO_SIDED|90.0|-34.09|8.78|||Barnard exact test|||Day 7||8.78|-34.09|0.9999
72597703|NCT00938587|144726843|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|10.56||||0.3027|TWO_SIDED|90.0|-17.18|37.67|||Barnard-Exact test|||Day 14||37.67|-17.18|0.3027
72597704|NCT00938587|144726843|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|21.67||||0.1074|TWO_SIDED|90.0|-6.24|46.16|||Barnard-Exact test|||Day 14||46.16|-6.24|0.1074
72597705|NCT00938587|144726843|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|17.46||||0.234|TWO_SIDED|90.0|-10.08|43.7|||Barnard-Exact test|||Day 14||43.70|-10.08|0.2340
72597706|NCT00938587|144726843|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|28.57||||0.0442|TWO_SIDED|90.0|0.91|53.07|||Barnard-Exact test|||Day 14||53.07|0.91|0.0442
72597707|NCT00938587|144726843|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|6.9||||0.3813|TWO_SIDED|90.0|-19.82|32.92|||Barnard-Exact test|||Day 14||32.92|-19.82|0.3813
72597708|NCT00938587|144726844|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|9.52||||0.1017|TWO_SIDED|90.0|-3.9|27.09|||Barnard exact test|||Day 7||27.09|-3.90|0.1017
72597709|NCT00938587|144726844|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|19.05||||0.0218|TWO_SIDED|90.0|4.49|38.44|||Barnard exact test|||Day 7||38.44|4.49|0.0218
72597710|NCT00938587|144726844|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|9.52||||0.1082|TWO_SIDED|90.0|-3.71|27.06|||Barnard exact test|||Day 7||27.06|-3.71|0.1082
72597711|NCT00938587|144726844|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|19.05||||0.0166|TWO_SIDED|90.0|4.81|38.44|||Barnard exact test|||Day 7||38.44|4.81|0.0166
72597712|NCT00938587|144726844|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|2.22||||0.4776|TWO_SIDED|90.0|-21.61|25.87|||Barnard exact test|||Day 14||25.87|-21.61|0.4776
72597713|NCT00938587|144726844|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|27.62||||0.0347|TWO_SIDED|90.0|2.53|50.78|||Barnard exact test|||Day 14||50.78|2.53|0.0347
72597714|NCT00938587|144726844|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|7.94||||0.3343|TWO_SIDED|90.0|-13.71|31.59|||Barnard exact test|||Day 14||31.59|-13.71|0.3343
72597715|NCT00938587|144726844|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|33.33||||0.0117|TWO_SIDED|90.0|8.35|55.0|||Barnard exact test|||Day 14||55.00|8.35|0.0117
72597716|NCT00938587|144726844|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|5.71||||0.372|TWO_SIDED|90.0|-15.86|27.04|||Barnard exact test|||Day 14||27.04|-15.86|0.3720
72597717|NCT00938587|144726845|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|4.76||||0.263|TWO_SIDED|90.0|-8.61|20.67|||Barnard exact test|||Day 7||20.67|-8.61|0.2630
72597718|NCT00938587|144726845|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|4.76||||0.263|TWO_SIDED|90.0|-8.61|20.67|||Barnard exact test|||Day 7||20.67|-8.61|0.2630
72597719|NCT00938587|144726845|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|4.76||||0.2539|TWO_SIDED|90.0|-7.51|20.67|||Barnard exact test|||Day 7||20.67|-7.51|0.2539
72597720|NCT00938587|144726845|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|4.76||||0.2539|TWO_SIDED|90.0|-7.51|20.67|||Barnard exact test|||Day 7||20.67|-7.51|0.2539
72597721|NCT00938587|144726845|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|14.29||||0.0477|TWO_SIDED|90.0|0.23|32.92|||Barnard exact test|||Day 14||32.92|0.23|0.0477
72597722|NCT00938587|144726845|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|14.29||||0.0442|TWO_SIDED|90.0|0.65|32.92|||Barnard exact test|||Day 14||32.92|0.65|0.0442
72597723|NCT00938587|144726848|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.2|STANDARD_ERROR_OF_MEAN|0.33||0.5403|TWO_SIDED|90.0|-0.34|0.75|||MMRM|||Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||0.75|-0.34|0.5403
72597724|NCT00938587|144726848|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.07|STANDARD_ERROR_OF_MEAN|0.33||0.8374|TWO_SIDED|90.0|-0.61|0.48|||MMRM|||Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||0.48|-0.61|0.8374
72597725|NCT00938587|144726848|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.26|STANDARD_ERROR_OF_MEAN|0.329||0.4305|TWO_SIDED|90.0|-0.28|0.8|||MMRM|||Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||0.80|-0.28|0.4305
72597726|NCT00938587|144726848|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.01|STANDARD_ERROR_OF_MEAN|0.325||0.9733|TWO_SIDED|90.0|-0.55|0.53|||MMRM|||Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||0.53|-0.55|0.9733
72597727|NCT00938587|144726848|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.06|STANDARD_ERROR_OF_MEAN|0.325||0.8613|TWO_SIDED|90.0|-0.48|0.6|||MMRM|||Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||0.60|-0.48|0.8613
72597728|NCT00938587|144726848|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.22|STANDARD_ERROR_OF_MEAN|0.341||0.5245|TWO_SIDED|90.0|-0.35|0.78|||MMRM|||Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||0.78|-0.35|0.5245
72597729|NCT00938587|144726848|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.05|STANDARD_ERROR_OF_MEAN|0.334||0.8917|TWO_SIDED|90.0|-0.6|0.51|||MMRM|||Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||0.51|-0.60|0.8917
72597730|NCT00938587|144726848|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.47|STANDARD_ERROR_OF_MEAN|0.339||0.1695|TWO_SIDED|90.0|-0.09|1.03|||MMRM|||Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||1.03|-0.09|0.1695
72597731|NCT00938587|144726848|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.2|STANDARD_ERROR_OF_MEAN|0.329||0.5339|TWO_SIDED|90.0|-0.34|0.75|||MMRM|||Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||0.75|-0.34|0.5339
72597732|NCT00938587|144726848|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.25|STANDARD_ERROR_OF_MEAN|0.332||0.452|TWO_SIDED|90.0|-0.3|0.8|||MMRM|||Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||0.80|-0.30|0.4520
72597733|NCT03743402|144726860|EQUIVALENCE|The null hypothesis was a point null of exactly 0 expected difference in MME/day between arms.|Mean Difference (Final Values)|-2.54||||0.58|TWO_SIDED|95.0|-10.55|5.88|||Regression, Linear||mean difference=(pain self-management)-(usual care)|A priori power calculations indicated 90% power to detect an average 24 MME/day difference between arms.||5.88|-10.55|0.58
72597734|NCT03743402|144726861|EQUIVALENCE|The null hypothesis was a point null of exactly 0 expected difference in PEG score between arms.|Mean Difference (Final Values)|0.01||||0.98|TWO_SIDED|95.0|-0.51|0.52|||Regression, Linear||mean difference = (pain self-management)-(usual care)|A priori power calculations indicated 90% power to detect a 1.2-point average difference in PEG score between arms.||0.52|-0.51|0.98
72597735|NCT03743402|144726862|EQUIVALENCE|The null hypothesis was a point null of exactly 0 difference in average MME/day between arms.|Mean Difference (Final Values)|1.3||||0.72|TWO_SIDED|95.0|-5.69|8.29|||Regression, Linear||mean difference=(pain self-management)-(usual care)|||8.29|-5.69|0.72
72597736|NCT03743402|144726863|EQUIVALENCE|The null hypothesis is a point null of exactly 0 difference in expected PEG score between arms.|Mean Difference (Final Values)|-0.53||||0.07|TWO_SIDED|95.0|-1.11|0.05|||Regression, Linear||mean difference = (pain self-management) - (usual care)|||0.05|-1.11|0.07
72597737|NCT03743402|144726864|EQUIVALENCE|The null hypothesis is a point null of exactly 0 expected difference in PSEQ score between arms.|Mean Difference (Final Values)|2.11||||0.8|TWO_SIDED|95.0|-13.83|18.04|||Regression, Linear||mean difference = (pain self-management) - (usual care)|||18.04|-13.83|0.80
72597738|NCT03743402|144726865|EQUIVALENCE|The null hypothesis is a point null of exactly 0 expected difference in PSEQ score between arms.|Mean Difference (Final Values)|4.33||||0.02|TWO_SIDED|95.0|0.56|8.09|||Regression, Linear||mean difference = (pain self-management) - (usual care)|||8.09|0.56|0.02
72597739|NCT03743402|144726866|EQUIVALENCE|The null hypothesis is a point null of exactly 0 expected difference in PHQ-8 score between arms.|Mean Difference (Final Values)|-0.35||||0.75|TWO_SIDED|95.0|-2.53|1.82|||Regression, Linear||mean difference = (pain self-management) - (usual care)|||1.82|-2.53|0.75
72597740|NCT03743402|144726867|EQUIVALENCE|The null hypothesis is a point null of exactly 0 expected difference in PHQ-8 score between arms.|Mean Difference (Final Values)|-0.5||||0.48|TWO_SIDED|95.0|-1.87|0.87|||Regression, Linear||mean difference = (pain self-management) - (usual care)|||0.87|-1.87|0.48
72597741|NCT03743402|144726868|EQUIVALENCE|The null hypothesis is a point null of exactly 0 expected difference in GAD-7 score between arms.|Mean Difference (Final Values)|-0.25||||0.64|TWO_SIDED|95.0|-1.31|0.81|||Regression, Linear||mean difference = (pain self-management) - (usual care)|||0.81|-1.31|0.64
72597742|NCT03743402|144726869|EQUIVALENCE|The null hypothesis is a point null of exactly 0 expected difference in GAD-7 score between arms.|Mean Difference (Final Values)|0.28||||0.65|TWO_SIDED|95.0|-0.94|1.51|||Regression, Linear||mean difference = (pain self-management) - (usual care)|||1.51|-0.94|0.65
72597743|NCT03743402|144726870|EQUIVALENCE|The null hypothesis is a point null of exactly 0 expected difference in PGIC score between arms.|Mean Difference (Final Values)|0.61||||0.02|TWO_SIDED|95.0|0.12|1.1|||Regression, Linear||mean difference = (pain self-management) - (usual care)|||1.10|0.12|0.02
72597744|NCT03743402|144726871|EQUIVALENCE|The null hypothesis is a point null of exactly 0 expected difference in PGIC score between arms.|Mean Difference (Final Values)|1.33|||<|0.01|TWO_SIDED|95.0|0.77|1.88|||Regression, Linear||mean difference = (pain self-management) - (usual care)|||1.88|0.77|<0.01
72415747|NCT00833638|144342416|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.8|||<|0.001|TWO_SIDED|95.0|6.48|19.12||No adjustment for multiplicity.|ANCOVA|Terms for baseline value of the efficacy variable, treatment, site, and the baseline-by-treatment interaction were included.||"Tested was the null-hypothesis that no differences in the percentages of participants who answered yes to the sexual encounter profile diary question number 1 exist between participants who received placebo and participants who received tadalafil 5 mg."||19.12|6.48|<0.001
72597745|NCT03743402|144726872|EQUIVALENCE|The null hypothesis is a point null of exactly 0 expected difference in POMI score between arms.|Mean Difference (Final Values)|0.09||||0.42|TWO_SIDED|95.0|-0.13|0.31|||Regression, Linear||mean difference = (pain self-management) - (usual care)|||0.31|-0.13|0.42
72597746|NCT03743402|144726873|EQUIVALENCE|The null hypothesis is a point null of exactly 0 expected difference in POMI score between arms.|Mean Difference (Final Values)|0.13||||0.26|TWO_SIDED|95.0|-0.1|0.36|||Regression, Linear||mean difference = (pain self-management) - (usual care)|||0.36|-0.10|0.26
72597747|NCT03743402|144726874|EQUIVALENCE|The null hypothesis is a point null of exactly 0 expected difference in PODS score between arms.|Mean Difference (Final Values)|1.6||||0.54|TWO_SIDED|95.0|-3.47|6.66|||Regression, Linear||mean difference = (pain self-management) - (usual care)|||6.66|-3.47|0.54
72421610|NCT03720938|144354383|SUPERIORITY|||||||3.67e-05||||||Linear mixed-effects model fit by maximum likelihood since restricted maximum likelihood assumes a strong normality.|Linear mixed-effects model|Adjusted by Satterthwaite's degrees of freedom method for cluster effect, and small sample sizes in addition to baseline value and age.||Null hypothesis was the absence of difference between the two groups for the dependent variable auditory reaction time of dominant hand.||||0.0000367
72597748|NCT03743402|144726875|EQUIVALENCE|The null hypothesis is a point null of exactly 0 expected difference in PODS score between arms.|Mean Difference (Final Values)|0.48||||0.59|TWO_SIDED|95.0|-1.26|2.21|||Regression, Linear||mean difference = (pain self-management) - (usual care)|||2.21|-1.26|0.59
72597749|NCT03743402|144726876|EQUIVALENCE|The null hypothesis is a point null of exactly 0 expected difference in opioid craving score between arms.|Mean Difference (Final Values)|-0.04||||0.9|TWO_SIDED|95.0|-0.66|0.57|||Regression, Linear||mean difference = (pain self-management) - (usual care)|||0.57|-0.66|0.90
72597750|NCT03743402|144726877|EQUIVALENCE|The null hypothesis is a point null of exactly 0 expected difference in PSEQ score between arms.|Mean Difference (Final Values)|-0.35||||0.3|TWO_SIDED|95.0|-1.03|0.32|||Regression, Linear||mean difference = (pain self-management) - (usual care)|||0.32|-1.03|0.30
72597751|NCT03743402|144726878|EQUIVALENCE|The null hypothesis is a point null of the relative risk of 30% reduction from baseline equal exactly to 1.|Risk Ratio (RR)|2.1||||0.2|TWO_SIDED|95.0|0.68|6.53|||Regression, Poison||relative risk = (pain self-management)/(usual care)|||6.53|0.68|0.20
72597752|NCT03743402|144726879|EQUIVALENCE|The null hypothesis is a point null of the relative risk of 30% reduction from baseline equal exactly to 1.|Risk Ratio (RR)|1.34||||0.53|TWO_SIDED|95.0|0.54|3.32|||Regression, Poison||relative risk = (pain self-management)/(usual care)|||3.32|0.54|0.53
72597753|NCT00048997|144726880|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.07||||0.2853|TWO_SIDED|95.0|0.84|1.38||One-sided significance level of 0.025.|Log Rank||Prophylactic cranial irradiation (PCI) is the reference arm for the hazard ratio.|This study was designed to detect a 20% relative improvement in hazard rate: null hypothesis (observation): MST (median survival time) = 23.5 mo.; alternative hypothesis (PCI): MST= 29.4 mo. A one-sided log-rank test at a significance level of 0.025 would have 80% power to detect this difference with a sample size of 1007 patients (527 deaths were required for the final analysis).||1.38|0.84|0.2853
72597754|NCT00048997|144726881|SUPERIORITY|||||||0.01|||||||Z-test, 2-sided|2-sided significance level = 0.05||||||0.01
72597755|NCT00048997|144726882|SUPERIORITY|||||||0.008|||||||Z-test, 2-sided|Significance level = 0.05||||||0.008
72597756|NCT00048997|144726883|SUPERIORITY|||||||0.2|||||||Z-test, 2-sided|Significance level = 0.05||||||0.20
72597757|NCT00048997|144726884|SUPERIORITY|||||||0.14|||||||Z-test, 2-sided|Significance level = 0.05||||||0.14
72597758|NCT00048997|144726885|SUPERIORITY|||||||0.52|||||||Z-test, 2-sided|Significance level = 0.05||||||0.52
72597759|NCT00048997|144726886|SUPERIORITY|||||||0.51|||||||Z-test, 2-sided|Significance level = 0.05||||||0.51
72597760|NCT00048997|144726887|SUPERIORITY|||||||0.11|||||||Other [Z-test, 2-sided]|Significance level = 0.05||||||0.11
72597761|NCT00048997|144726888|SUPERIORITY||Odds Ratio (OR)|2.52||||0.005|TWO_SIDED|95.0|1.32|4.8|||Regression, Logistic|2-sided significance level = 0.05|Reference level = PCI arm|The development of CNS metastases was assessed using logistic regression modeling comparing presence vs. absence of brain metastases at 1 year.||4.80|1.32|0.005
72597762|NCT02007278|144726898|NON_INFERIORITY_OR_EQUIVALENCE|Power=95%; significance level=5%, characteristic operation curves were used with a non-central F distribution for the calculation of the sample size||||||0.451|||||||Wilcoxon (Mann-Whitney)|||||||0.4510
72597763|NCT00435188|144726914|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Omnibus p value for group difference between groups at the end of the study and group by time interaction|Mixed Models Analysis|||||||<0.001
72597764|NCT00435188|144726917|SUPERIORITY_OR_OTHER|||||||0.47|TWO_SIDED||||||Mixed Models Analysis|||Omnibus P value reporting overall differences between groups for group and group by time interaction with two degrees of freedom||||0.47
72597765|NCT00435188|144726920|SUPERIORITY_OR_OTHER|||||||0.04|TWO_SIDED||||||Mixed Models Analysis|||Omnibus P value for overall difference between groups at the end of the study and group by time interaction on two degrees of freedom||||0.04
72597766|NCT00435188|144726921|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||Omnibus P value provides the overall differences between groups at the end of the study||||<0.001
72597767|NCT00435188|144726924|SUPERIORITY_OR_OTHER|||||||0.29|TWO_SIDED||||||Mixed Models Analysis|||Omnibus P value provides the overall difference between groups at the end of the study||||0.29
72597768|NCT00435188|144726927|SUPERIORITY_OR_OTHER|||||||0.35|TWO_SIDED||||||Mixed Models Analysis|||P value provides overall differences between groups at the end of the study||||0.35
72597769|NCT00435188|144726930|SUPERIORITY_OR_OTHER|||||||0.08|TWO_SIDED||||||Mixed Models Analysis|||P value provides the overall differences between groups at the end of the study||||0.08
72597770|NCT00497055|144726931|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.88||||0.41||95.0|0.66|1.16|||Generalized estimating equation|||||1.16|.66|.41
72597771|NCT00497055|144726932|SUPERIORITY_OR_OTHER|||||||0.31||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.31
72597772|NCT00497055|144726933|SUPERIORITY_OR_OTHER||||||>=|0.99|||||||Fisher Exact|||||||>=0.99
72415748|NCT00833638|144342417|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|15.4|||<|0.001|TWO_SIDED|95.0|8.51|22.29||No adjustment for multiplicity.|ANCOVA|Included were terms for baseline value of the efficacy variable, treatment, site, and the baseline-by-treatment interaction.||"Tested was the null-hypothesis that no differences in the percentages of participants who answered yes to the sexual encounter profile diary question number 2 exist between participants who received placebo and participants who received tadalafil 2.5 mg."||22.29|8.51|<0.001
72415749|NCT00833638|144342417|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|20.41|||<|0.001|TWO_SIDED|95.0|13.5|27.31||No adjustment for multiplicity.|ANCOVA|Included were terms for baseline value of the efficacy variable, treatment, site, and the baseline-by-treatment interaction.||"Tested was the null-hypothesis that no differences in the percentages of participants who answered yes to the sexual encounter profile diary question number 2 exist between participants who received placebo and participants who received tadalafil 5 mg."||27.31|13.50|<0.001
72597773|NCT00055497|144726944|SUPERIORITY_OR_OTHER|||||||0.142|||||||Log Rank|||||||0.142
72597774|NCT00055497|144726945|SUPERIORITY_OR_OTHER|||||||0.029|||||||Fisher Exact|||||||0.029
72597775|NCT00055497|144726946|SUPERIORITY_OR_OTHER|||||||0.33|||||||Fisher Exact|||Week 24||||0.330
72597776|NCT00055497|144726946|SUPERIORITY_OR_OTHER|||||||0.001|||||||Fisher Exact|||Week 24||||0.001
72597777|NCT00055497|144726946|SUPERIORITY_OR_OTHER|||||||0.508|||||||Fisher Exact|||Week 56||||0.508
72597778|NCT00055497|144726946|SUPERIORITY_OR_OTHER|||||||0.044|||||||Fisher Exact|||Week 56||||0.044
72597779|NCT00055497|144726947|SUPERIORITY_OR_OTHER|||||||0.191|||||||Fisher Exact|||Week 24||||0.191
72597780|NCT00055497|144726947|SUPERIORITY_OR_OTHER|||||||0.003||95.0|||||Fisher Exact|||Week 24||||0.003
72597781|NCT00055497|144726947|SUPERIORITY_OR_OTHER|||||||0.508|||||||Fisher Exact|||Week 56||||0.508
72597782|NCT00055497|144726947|SUPERIORITY_OR_OTHER|||||||0.004|||||||Fisher Exact|||Week 56||||0.004
72597783|NCT00055497|144726948|SUPERIORITY_OR_OTHER|||||||0.001|||||||Fisher Exact|||||||0.001
72597784|NCT01693185|144726976|SUPERIORITY_OR_OTHER||||||<|0.001||||||We wished to be able to distinguish a difference of 7.5 min,|Wilcoxon (Mann-Whitney)|||Recovery time in patients administered remifentanil alone will be significantly shorter than that in patients administered midazolam-meperidine combination for colonoscopy.||||< 0.001
72597785|NCT02503254|144727005|SUPERIORITY_OR_OTHER_LEGACY||Geometric LS Mean Reduction|82.82|||<|0.001|TWO_SIDED|95.0|78.79|86.09||The primary endpoints were tested using a multiple testing procedure to preserve the overall alpha level by simultaneously testing the endpoints using a closed procedure with each test performed at a two-sided alpha level of 5%.|ANCOVA|ANCOVA model on MHBMA levels with product, sex, cigarette consumption, and baseline value as covariates.|"Geometric LS Mean Reduction = 100 - (CHTP 1.0 : CC ratio)~Expressed as %"|"The hypothesis to be tested is that the geometric mean level on Day 5 of the biomarker of exposure for CHTP 1.0 is lower relative to CC.~Analysis of the BoExp was conducted on the natural log scale in order to test the following hypothesis (one sided test with 2.5% type I error probability):~* Null hypothesis (H0): m1≥m2~* Alternative hypothesis (H1): m1\<m2 Where m1 and m2 are the geometric means of the BoExp levels on Day 5 for CHTP 1.0 and CC, respectively."||86.09|78.79|<.001
72597786|NCT02503254|144727006|SUPERIORITY_OR_OTHER_LEGACY||Geometric LS Mean Reduction|63.53|||<|0.001|TWO_SIDED|95.0|59.55|67.12||The primary endpoints were tested using a multiple testing procedure to preserve the overall alpha level by simultaneously testing the endpoints using a closed procedure with each test performed at a two-sided alpha level of 5%.|ANCOVA|ANCOVA model on 3-HPMA levels with product, sex, cigarette consumption, and baseline value as covariates.|"Geometric LS Mean Reduction = 100 - (CHTP 1.0 : CC ratio)~Expressed as %"|"The hypothesis to be tested is that the geometric mean level on Day 5 of the biomarker of exposure for CHTP 1.0 is lower relative to CC.~Analysis of the BoExp was conducted on the natural log scale in order to test the following hypothesis (one sided test with 2.5% type I error probability):~* Null hypothesis (H0): m1≥m2~* Alternative hypothesis (H1): m1\<m2 Where m1 and m2 are the geometric means of the BoExp levels on Day 5 for CHTP 1.0 and CC, respectively"||67.12|59.55|<0.001
72597787|NCT02503254|144727007|SUPERIORITY_OR_OTHER_LEGACY||Geometric LS Mean Reduction|88.14|||<|0.001|TWO_SIDED|95.0|86.46|89.62||The primary endpoints were tested using a multiple testing procedure to preserve the overall alpha level by simultaneously testing the endpoints using a closed procedure with each test performed at a two-sided alpha level of 5%.|ANCOVA|ANCOVA model on MHBMA levels with product, sex, cigarette consumption, and baseline value as covariates|"Geometric LS Mean Reduction = 100 - (CHTP 1.0 : CC ratio)~Expressed as %"|"The hypothesis to be tested is that the geometric mean level on Day 5 of the biomarker of exposure for CHTP 1.0 is lower relative to CC.~Analysis of the BoExp was conducted on the natural log scale in order to test the following hypothesis (one sided test with 2.5% type I error probability):~* Null hypothesis (H0): m1≥m2~* Alternative hypothesis (H1): m1\<m2 Where m1 and m2 are the geometric means of the BoExp levels on Day 5 for CHTP 1.0 and CC, respectively."||89.62|86.46|<.001
72597788|NCT02503254|144727008|SUPERIORITY_OR_OTHER_LEGACY||Geometric LS Mean Ratio|58.83|||<|0.001|TWO_SIDED|95.0|49.3|66.56||The primary endpoints were tested using a multiple testing procedure to preserve the overall alpha level by simultaneously testing the endpoints using a closed procedure with each test performed at an alpha level of 2.5% one sided.|ANCOVA|ANCOVA model on COHb levels with product, sex, cigarette consumption, and baseline value as covariates.|"Geometric LS Mean Reduction = 100 - (CHTP 1.0 : CC ratio)~Expressed as %"|"The hypothesis to be tested is that the geometric mean level on Day 5 of the biomarker of exposure for CHTP 1.0 is lower relative to CC.~Analysis of the BoExp was conducted on the natural log scale in order to test the following hypothesis (one sided test with 2.5% type I error probability):~* Null hypothesis (H0): m1≥m2~* Alternative hypothesis (H1): m1\<m2 Where m1 and m2 are the geometric means of the BoExp levels on Day 5 for CHTP 1.0 and CC respectively."||66.56|49.30|<.001
72597789|NCT00094536|144727048|SUPERIORITY_OR_OTHER|||||||0.271|||||||1-sided z-test|1-sided z-test with continuity correction (pooled)||||||.271
72597790|NCT04494425|144727070|SUPERIORITY||Hazard Ratio (HR)|0.62|||<|0.0001|TWO_SIDED|95.0|0.52|0.75|||Log Rank|The analysis was performed using the stratified log-rank test.|HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for prior cyclin-dependent kinase (CDK)4/6 inhibitor use (yes versus no) and HER2 IHC expression (IHC 1+ versus IHC 2+/ISH-) and ties handled by Efron approach.|||0.75|0.52|<0.0001
72597791|NCT01026818|144727109|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.14||||0.675|TWO_SIDED|95.0|0.63|2.06||The Type I error was controlled for multiplicity using a Bonferroni-Hommel procedure. First the largest p-value for the odds ratio to placebo was tested at the 5% level and in case of no rejection the second p-value was tested at the 2.5% level.|Regression, Logistic|The logistic regression model included terms for treatment group, country, and age group.||A sample size of 412 randomized participants provided 84% power to detect a 20% difference in the proportions for the 3 treatment groups. The sample size allowed for a 20% withdrawal during the study.||2.06|0.63|0.675
72597792|NCT01026818|144727109|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.89||||0.704|TWO_SIDED|95.0|0.48|1.65||The Type I error was controlled for multiplicity using a Bonferroni-Hommel procedure. First the largest p-value for the odds ratio to placebo was tested at the 5% level and in case of no rejection the second p-value was tested at the 2.5% level.|Regression, Logistic|The logistic regression model included terms for treatment group, country, and age group.||A sample size of 412 randomized participants provided 84% power to detect a 20% difference in the proportions for the 3 treatment groups. The sample size allowed for a 20% withdrawal during the study.||1.65|0.48|0.704
72597793|NCT01026818|144727110|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.15||||0.016|TWO_SIDED|95.0|1.16|3.99||P-value is for Month 9.|Regression, Logistic|The logistic regression model included terms for treatment group, country, and age group.||||3.99|1.16|0.016
72597794|NCT01026818|144727110|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.5||||0.21|TWO_SIDED|95.0|0.79|2.85||P-value is for Month 9.|Regression, Logistic|The logistic regression model included terms for treatment group, country, and age group.||||2.85|0.79|0.210
72597795|NCT01026818|144727110|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.34||||0.273|TWO_SIDED|95.0|0.79|2.28||P-value is for Month 13.5.|Regression, Logistic|The logistic regression model included terms for treatment group, country, and age group.||||2.28|0.79|0.273
72597796|NCT01026818|144727110|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.35||||0.259|TWO_SIDED|95.0|0.8|2.29||P-value is for Month 13.5.|Regression, Logistic|The logistic regression model included terms for treatment group, country, and age group.||||2.29|0.80|0.259
72597797|NCT01026818|144727111|SUPERIORITY_OR_OTHER||LS Mean Differences|2.8|STANDARD_ERROR_OF_MEAN|1.03||0.007|TWO_SIDED|95.0|0.76|4.83||P-value is for Month 9.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||4.83|0.76|0.007
72597798|NCT01026818|144727111|SUPERIORITY_OR_OTHER||LS Mean differences|1.59|STANDARD_ERROR_OF_MEAN|1.02||0.118|TWO_SIDED|95.0|-0.41|3.6||P-value is for Month 9.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||3.60|-0.41|0.118
72421611|NCT03720938|144354384|SUPERIORITY|||||||0.008||||||The outcomes of auditory reaction time of non-dominant hand was tested for any difference between groups by covariate analysis.|ANCOVA|Adjusted for the auditory reaction time of non-dominant hand at baseline and confounding variable age.||Null hypothesis was the absence of difference between the two groups for the dependent variable auditory reaction time of non-dominant hand.||||0.008
72597799|NCT01026818|144727111|SUPERIORITY_OR_OTHER||LS Mean Differences|0.26|STANDARD_ERROR_OF_MEAN|1.04||0.802|TWO_SIDED|95.0|-1.79|2.31||P-value is for Month 10.5.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||2.31|-1.79|0.802
72597800|NCT01026818|144727111|SUPERIORITY_OR_OTHER||LS Mean Differences|-0.22|STANDARD_ERROR_OF_MEAN|1.02||0.83|TWO_SIDED|95.0|-2.23|1.79||P-value is for Month 10.5.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||1.79|-2.23|0.830
72597801|NCT01026818|144727111|SUPERIORITY_OR_OTHER||LS Mean Differences|1.62|STANDARD_ERROR_OF_MEAN|1.22||0.184|TWO_SIDED|95.0|-0.78|4.03||P-value is for Month 13.5.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||4.03|-0.78|0.184
72597802|NCT01026818|144727111|SUPERIORITY_OR_OTHER||LS Mean Differences|0.81|STANDARD_ERROR_OF_MEAN|1.2||0.5|TWO_SIDED|95.0|-1.54|3.16||P-value is for Month 13.5.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||3.16|-1.54|0.500
72597803|NCT01026818|144727112|SUPERIORITY_OR_OTHER||LS Mean Differences|0.37|STANDARD_ERROR_OF_MEAN|0.39||0.34||95.0|-0.39|1.14||P-value is for orgasmic function - Month 9.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||1.14|-0.39|0.340
72597804|NCT01026818|144727112|SUPERIORITY_OR_OTHER||LS Mean Differences|0.09|STANDARD_ERROR_OF_MEAN|0.38||0.821|TWO_SIDED|95.0|-0.67|0.84||P-value is for orgasmic function - Month 9.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||0.84|-0.67|0.821
72597805|NCT01026818|144727112|SUPERIORITY_OR_OTHER||LS Mean Differences|0.46|STANDARD_ERROR_OF_MEAN|0.42||0.268|TWO_SIDED|95.0|-0.36|1.28||P-value is for orgasmic function - Month 10.5.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||1.28|-0.36|0.268
72597806|NCT01026818|144727112|SUPERIORITY_OR_OTHER||LS Mean Differences|0.0|STANDARD_ERROR_OF_MEAN|0.41||0.998|TWO_SIDED|95.0|-0.8|0.8||P-value is for orgasmic function - Month 10.5.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||0.80|-0.80|0.998
72597807|NCT01026818|144727112|SUPERIORITY_OR_OTHER||LS Mean Differences|0.15|STANDARD_ERROR_OF_MEAN|0.42||0.728|TWO_SIDED|95.0|-0.68|0.97||P-value is for orgasmic function - Month 13.5.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||0.97|-0.68|0.728
72597808|NCT01026818|144727112|SUPERIORITY_OR_OTHER||LS Mean Differences|-0.52|STANDARD_ERROR_OF_MEAN|0.41||0.203|TWO_SIDED|95.0|-1.33|0.28||P-value is for orgasmic function - Month 13.5.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||0.28|-1.33|0.203
72597809|NCT01026818|144727112|SUPERIORITY_OR_OTHER||LS Mean Differences|0.02|STANDARD_ERROR_OF_MEAN|0.24||0.95|TWO_SIDED|95.0|-0.46|0.49||P-value is for sexual desire - Month 9.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||0.49|-0.46|0.950
72597810|NCT01026818|144727112|SUPERIORITY_OR_OTHER||LS Mean Differences|0.01|STANDARD_ERROR_OF_MEAN|0.24||0.95|TWO_SIDED|95.0|-0.45|0.48||P-value is for sexual desire - Month 9.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||0.48|-0.45|0.950
72415750|NCT00833638|144342418|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.27|||<|0.001|TWO_SIDED|95.0|6.83|21.71||No adjustment for multiplicity.|ANCOVA|Included were terms for baseline value of the efficacy variable, treatment, site, and the baseline-by-treatment interaction.||"Tested was the null-hypothesis that no differences in the percentages of participants who answered yes to the sexual encounter profile diary question number 3 exist between participants who received placebo and participants who received tadalafil 2.5 mg."||21.71|6.83|<0.001
72421612|NCT03720938|144354384|SUPERIORITY|||||||0.006||||||Linear mixed-effects model fit by maximum likelihood since restricted maximum likelihood assumes a strong normality.|Linear mixed effects model|Adjusted for cluster effect in addition to baseline value and age.||Null hypothesis was the absence of difference between the two groups for the dependent variable auditory reaction time of non-dominant hand.||||0.006
72597811|NCT01026818|144727112|SUPERIORITY_OR_OTHER||LS Mean Differences|0.06|STANDARD_ERROR_OF_MEAN|0.23||0.792|TWO_SIDED|95.0|-0.39|0.51||P-value is for sexual desire - Month 10.5.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||0.51|-0.39|0.792
72597812|NCT01026818|144727112|SUPERIORITY_OR_OTHER||LS Mean Differences|0.11|STANDARD_ERROR_OF_MEAN|0.23||0.631|TWO_SIDED|95.0|-0.34|0.55||P-value is for sexual desire - Month 10.5.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||0.55|-0.34|0.631
72597813|NCT01026818|144727112|SUPERIORITY_OR_OTHER||LS Mean Differences|0.1|STANDARD_ERROR_OF_MEAN|0.24||0.691|TWO_SIDED|95.0|-0.38|0.58||P-value is for sexual desire - Month 13.5.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||0.58|-0.38|0.691
72597814|NCT01026818|144727112|SUPERIORITY_OR_OTHER||LS Mean Differences|-0.06|STANDARD_ERROR_OF_MEAN|0.24||0.801|TWO_SIDED|95.0|-0.53|0.41||P-value is for sexual desire - Month 13.5.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||0.41|-0.53|0.801
72597815|NCT01026818|144727112|SUPERIORITY_OR_OTHER||LS Mean Differences|0.93|STANDARD_ERROR_OF_MEAN|0.5||0.065|TWO_SIDED|95.0|-0.06|1.92||P-value is for intercourse satisfaction - Month 9.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||1.92|-0.06|0.065
72597816|NCT01026818|144727112|SUPERIORITY_OR_OTHER||LS Mean Differences|0.54|STANDARD_ERROR_OF_MEAN|0.49||0.274|TWO_SIDED|95.0|-0.43|1.51||P-value is for intercourse satisfaction - Month 9.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||1.51|-0.43|0.274
72597817|NCT01026818|144727112|SUPERIORITY_OR_OTHER||LS Mean Differences|0.48|STANDARD_ERROR_OF_MEAN|0.53||0.359|TWO_SIDED|95.0|-0.55|1.52||P-value is for intercourse satisfaction - Month 10.5.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||1.52|-0.55|0.359
72597818|NCT01026818|144727112|SUPERIORITY_OR_OTHER||LS Mean Differences|0.09|STANDARD_ERROR_OF_MEAN|0.52||0.863|TWO_SIDED|95.0|-0.93|1.11||P-value is for intercourse satisfaction - Month 10.5.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||1.11|-0.93|0.863
72597819|NCT01026818|144727112|SUPERIORITY_OR_OTHER||LS Mean Differences|0.56|STANDARD_ERROR_OF_MEAN|0.56||0.314|TWO_SIDED|95.0|-0.53|1.66||P-value is for intercourse satisfaction - Month 13.5.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||1.66|-0.53|0.314
72597820|NCT01026818|144727112|SUPERIORITY_OR_OTHER||LS Mean Differences|-0.06|STANDARD_ERROR_OF_MEAN|0.54||0.91|TWO_SIDED|95.0|-1.13|1.01||P-value is for intercourse satisfaction - Month 13.5.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||1.01|-1.13|0.910
72597821|NCT01026818|144727112|SUPERIORITY_OR_OTHER||LS Mean Differences|0.19|STANDARD_ERROR_OF_MEAN|0.3||0.532|TWO_SIDED|95.0|-0.4|0.78||P-value is for overall satisfaction - Month 9.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||0.78|-0.40|0.532
72597822|NCT01026818|144727112|SUPERIORITY_OR_OTHER||LS Mean Differences|0.15|STANDARD_ERROR_OF_MEAN|0.3||0.62|TWO_SIDED|95.0|-0.43|0.73||P-value is for overall satisfaction - Month 9.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||0.73|-0.43|0.620
72597823|NCT01026818|144727112|SUPERIORITY_OR_OTHER||LS Mean Differences|-0.08|STANDARD_ERROR_OF_MEAN|0.3||0.792|TWO_SIDED|95.0|-0.67|0.51||P-value is for overall satisfaction - Month 10.5.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||0.51|-0.67|0.792
72597824|NCT01026818|144727112|SUPERIORITY_OR_OTHER||LS Mean Differences|-0.24|STANDARD_ERROR_OF_MEAN|0.29||0.41|TWO_SIDED|95.0|-0.82|0.34||P-value is for overall satisfaction - Month 10.5.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||0.34|-0.82|0.410
72597825|NCT01026818|144727112|SUPERIORITY_OR_OTHER||LS Mean Differences|-0.02|STANDARD_ERROR_OF_MEAN|0.34||0.955||95.0|-0.68|0.65||P-value is for overall satisfaction - Month 13.5.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||0.65|-0.68|0.955
72597826|NCT01026818|144727112|SUPERIORITY_OR_OTHER||LS Mean Differences|0.05|STANDARD_ERROR_OF_MEAN|0.33||0.868|TWO_SIDED|95.0|-0.59|0.7||P-value is for overall satisfaction - Month 13.5.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||0.70|-0.59|0.868
72597827|NCT01026818|144727113|SUPERIORITY_OR_OTHER||LS Mean Differences|0.33|STANDARD_ERROR_OF_MEAN|0.12||0.005|TWO_SIDED|95.0|0.1|0.56||P-value is for Month 9.|Mixed Models Analysis|The MMRM model included terms for treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||0.56|0.10|0.005
72597828|NCT01026818|144727113|SUPERIORITY_OR_OTHER||LS Mean Differences|0.23|STANDARD_ERROR_OF_MEAN|0.11||0.041|TWO_SIDED|95.0|0.01|0.45||P-value is for Month 9.|Mixed Models Analysis|The MMRM model included terms for treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||0.45|0.01|0.041
72597829|NCT01026818|144727113|SUPERIORITY_OR_OTHER||LS Mean Differences|0.28|STANDARD_ERROR_OF_MEAN|0.13||0.035||95.0|0.02|0.54||P-value is for Month 13.5.|Mixed Models Analysis|The MMRM model included terms for treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||0.54|0.02|0.035
72597830|NCT01026818|144727113|SUPERIORITY_OR_OTHER||LS Mean Differences|0.13|STANDARD_ERROR_OF_MEAN|0.13||0.316|TWO_SIDED|95.0|-0.12|0.38||P-value is for Month 13.5.|Mixed Models Analysis|The MMRM model included terms for treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||0.38|-0.12|0.316
72597831|NCT01026818|144727114|SUPERIORITY_OR_OTHER||LS Mean Differences|1.75|STANDARD_ERROR_OF_MEAN|1.02||0.086|TWO_SIDED|95.0|-0.25|3.76||P-value is for sexual relationship - Month 9.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||3.76|-0.25|0.086
72597832|NCT01026818|144727114|SUPERIORITY_OR_OTHER||LS Mean Differences|0.47|STANDARD_ERROR_OF_MEAN|1.0||0.637|TWO_SIDED|95.0|-1.5|2.45||P-value is for sexual relationship - Month 9.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||2.45|-1.50|0.637
72415751|NCT00833638|144342418|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|20.54|||<|0.001|TWO_SIDED|95.0|13.07|28.01||No adjustment for multiplicity.|ANCOVA|Included were terms for baseline value of the efficacy variable, treatment, site, and the baseline-by-treatment interaction.||"Tested was the null-hypothesis that no differences in the percentages of participants who answered yes to the sexual encounter profile diary question number 3 exist between participants who received placebo and participants who received tadalafil 5 mg."||28.01|13.07|<0.001
72597833|NCT01026818|144727114|SUPERIORITY_OR_OTHER||LS Mean Differences|0.17|STANDARD_ERROR_OF_MEAN|1.2||0.885|TWO_SIDED|95.0|-2.18|2.53||P-value is for sexual relationship - Month 13.5|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||2.53|-2.18|0.885
72597834|NCT01026818|144727114|SUPERIORITY_OR_OTHER||LS Mean Differences|-0.04|STANDARD_ERROR_OF_MEAN|1.17||0.972|TWO_SIDED|95.0|-2.34|2.25||P-value is for sexual relationship - Month 13.5.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||2.25|-2.34|0.972
72597835|NCT01026818|144727114|SUPERIORITY_OR_OTHER||LS Mean Differences|0.27|STANDARD_ERROR_OF_MEAN|0.55||0.621|TWO_SIDED|95.0|-0.81|1.36||P-value is for self-esteem - Month 9.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||1.36|-0.81|0.621
72597836|NCT01026818|144727114|SUPERIORITY_OR_OTHER||LS Mean Differences|0.29|STANDARD_ERROR_OF_MEAN|0.54||0.598|TWO_SIDED|95.0|-0.78|1.35||P-value is for self-esteem - Month 9.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||1.35|-0.78|0.598
72597837|NCT01026818|144727114|SUPERIORITY_OR_OTHER||LS Mean Differences|0.06|STANDARD_ERROR_OF_MEAN|0.59||0.923|TWO_SIDED|95.0|-1.1|1.21||P-value is for self-esteem - Month 13.5.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||1.21|-1.10|0.923
72597838|NCT01026818|144727114|SUPERIORITY_OR_OTHER||LS Mean Differences|0.1|STANDARD_ERROR_OF_MEAN|0.58||0.857|TWO_SIDED|95.0|-1.03|1.24||P-value is for self-esteem - Month 13.5.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||1.24|-1.03|0.857
72597839|NCT01026818|144727125|SUPERIORITY_OR_OTHER||LS Mean Differences|14.87|STANDARD_ERROR_OF_MEAN|5.57||0.008|TWO_SIDED|95.0|3.92|25.83||P-value is for Q1 - Month 9.|Mixed Models Analysis|The MMRM model included terms for treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||25.83|3.92|0.008
72597840|NCT01026818|144727125|SUPERIORITY_OR_OTHER||LS Mean Differences|11.34|STANDARD_ERROR_OF_MEAN|5.45||0.038|TWO_SIDED|95.0|0.63|22.04||P-value is for Q1 - Month 9.|Mixed Models Analysis|The MMRM model included terms for treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||22.04|0.63|0.038
72597841|NCT01026818|144727125|SUPERIORITY_OR_OTHER||LS Mean Differences|8.91|STANDARD_ERROR_OF_MEAN|6.15||0.148|TWO_SIDED|95.0|-3.18|21.0||P-value is for Q1 - Month 10.5.|Mixed Models Analysis|The MMRM model included terms for treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||21.00|-3.18|0.148
72597842|NCT01026818|144727125|SUPERIORITY_OR_OTHER||LS Mean Differences|5.37|STANDARD_ERROR_OF_MEAN|6.03||0.373|TWO_SIDED|95.0|-6.48|17.23||P-value is for Q1 - Month 10.5.|Mixed Models Analysis|The MMRM model included terms for treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||17.23|-6.48|0.373
72597843|NCT01026818|144727125|SUPERIORITY_OR_OTHER||LS Mean Differences|10.9|STANDARD_ERROR_OF_MEAN|4.96||0.029|TWO_SIDED|95.0|1.14|20.66||P-value is for Q1 - Month 13.5.|Mixed Models Analysis|The MMRM model included terms for treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||20.66|1.14|0.029
72597844|NCT01026818|144727125|SUPERIORITY_OR_OTHER||LS Mean Differences|4.53|STANDARD_ERROR_OF_MEAN|4.91||0.357|TWO_SIDED|95.0|-5.12|14.17||P-value is for Q1 - Month 13.5.|Mixed Models Analysis|The MMRM model included terms for treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||14.17|-5.12|0.357
72597845|NCT01026818|144727125|SUPERIORITY_OR_OTHER||LS Mean Differences|16.33|STANDARD_ERROR_OF_MEAN|5.42||0.003|TWO_SIDED|95.0|5.68|26.98||P-value is for Q2 - Month 9.|Mixed Models Analysis|The MMRM model included terms for treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||26.98|5.68|0.003
72597846|NCT01026818|144727125|SUPERIORITY_OR_OTHER||LS Mean Differences|6.62|STANDARD_ERROR_OF_MEAN|5.3||0.212|TWO_SIDED|95.0|-3.8|17.04||P-value is for Q2 - Month 9.|Mixed Models Analysis|The MMRM model included terms for treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||17.04|-3.80|0.212
72597847|NCT01026818|144727125|SUPERIORITY_OR_OTHER||LS Mean Differences|4.55|STANDARD_ERROR_OF_MEAN|6.17||0.461|TWO_SIDED|95.0|-7.58|16.68||P-value is for Q2 - Month 10.5.|Mixed Models Analysis|The MMRM model included terms for treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||16.68|-7.58|0.461
72597848|NCT01026818|144727125|SUPERIORITY_OR_OTHER||LS Mean Differences|-1.26|STANDARD_ERROR_OF_MEAN|6.05||0.835|TWO_SIDED|95.0|-13.16|10.63||P-value is for Q2 - Month 10.5.|Mixed Models Analysis|The MMRM model included terms for treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||10.63|-13.16|0.835
72597849|NCT01026818|144727125|SUPERIORITY_OR_OTHER||LS Mean Differences|13.36|STANDARD_ERROR_OF_MEAN|6.15||0.03|TWO_SIDED|95.0|1.27|25.46||P-value is for Q2 - Month13.5.|Mixed Models Analysis|The MMRM model included terms for treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||25.46|1.27|0.030
72597850|NCT01026818|144727125|SUPERIORITY_OR_OTHER||LS Mean Differences|5.96|STANDARD_ERROR_OF_MEAN|6.07||0.326|TWO_SIDED|95.0|-5.97|17.89||P-value is for Q2 - Month13.5.|Mixed Models Analysis|The MMRM model included terms for treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||17.89|-5.97|0.326
72597851|NCT01026818|144727125|SUPERIORITY_OR_OTHER||LS Mean Differences|12.06|STANDARD_ERROR_OF_MEAN|5.13||0.019||95.0|1.98|22.15||P-value is for Q3 - Month 9.|Mixed Models Analysis|The MMRM model included terms for treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||22.15|1.98|0.019
72597852|NCT01026818|144727125|SUPERIORITY_OR_OTHER||LS Mean Differences|2.48|STANDARD_ERROR_OF_MEAN|5.02||0.621|TWO_SIDED|95.0|-7.38|12.35||P-value is for Q3 - Month 9.|Mixed Models Analysis|The MMRM model included terms for treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||12.35|-7.38|0.621
72597853|NCT01026818|144727125|SUPERIORITY_OR_OTHER||LS Mean Differences|0.23|STANDARD_ERROR_OF_MEAN|5.73||0.968||95.0|-11.03|11.49||P-value is for Q3 - Month 10.5.|Mixed Models Analysis|The MMRM model included terms for treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||11.49|-11.03|0.968
72597854|NCT01026818|144727125|SUPERIORITY_OR_OTHER||LS Mean Differences|-5.51|STANDARD_ERROR_OF_MEAN|5.62||0.327|TWO_SIDED|95.0|-16.55|5.54||P-value is for Q3 - Month 10.5.|Mixed Models Analysis|The MMRM model included terms for treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||5.54|-16.55|0.327
72597855|NCT01026818|144727125|SUPERIORITY_OR_OTHER||LS Mean Differences|11.67|STANDARD_ERROR_OF_MEAN|6.32||0.066|TWO_SIDED|95.0|-0.76|24.09||P-value is for Q3 - Month 13.5.|Mixed Models Analysis|The MMRM model included terms for treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||24.09|-0.76|0.066
72597856|NCT01026818|144727125|SUPERIORITY_OR_OTHER||LS Mean Differences|5.09|STANDARD_ERROR_OF_MEAN|6.23||0.415|TWO_SIDED|95.0|-7.17|17.34||P-value is for Q3 - Month 13.5.|Mixed Models Analysis|The MMRM model included terms for treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||17.34|-7.17|0.415
72597857|NCT01026818|144727125|SUPERIORITY_OR_OTHER||LS Mean Differences|11.87|STANDARD_ERROR_OF_MEAN|4.61||0.011|TWO_SIDED|95.0|2.79|20.94||P-value is for Q4 - Month 9.|Mixed Models Analysis|The MMRM model included terms for treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||20.94|2.79|0.011
72597858|NCT01026818|144727125|SUPERIORITY_OR_OTHER||LS Mean Differences|3.85|STANDARD_ERROR_OF_MEAN|4.51||0.394|TWO_SIDED|95.0|-5.03|12.72||P-value is for Q4 - Month 9.|Mixed Models Analysis|The MMRM model included terms for treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||12.72|-5.03|0.394
72597859|NCT01026818|144727125|SUPERIORITY_OR_OTHER||LS Mean Differences|-1.94|STANDARD_ERROR_OF_MEAN|4.75||0.684|TWO_SIDED|95.0|-11.28|7.41||P-value is for Q4 - Month 10.5.|Mixed Models Analysis|The MMRM model included terms for treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||7.41|-11.28|0.684
72597860|NCT01026818|144727125|SUPERIORITY_OR_OTHER||LS Mean Differences|-7.14|STANDARD_ERROR_OF_MEAN|4.66||0.126|TWO_SIDED|95.0|-16.3|2.02||P-value is for Q4 - Month 10.5.|Mixed Models Analysis|The MMRM model included terms for treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||2.02|-16.30|0.126
72597861|NCT01026818|144727125|SUPERIORITY_OR_OTHER||LS Mean Differences|11.52|STANDARD_ERROR_OF_MEAN|6.13||0.061|TWO_SIDED|95.0|-0.53|23.57||P-value is for Q4 - Month 13.5.|Mixed Models Analysis|The MMRM model included terms for treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||23.57|-0.53|0.061
72597862|NCT01026818|144727125|SUPERIORITY_OR_OTHER||LS Mean Differences|5.06|STANDARD_ERROR_OF_MEAN|6.05||0.403|TWO_SIDED|95.0|-6.83|16.95||P-value is for Q4 - Month13.5.|Mixed Models Analysis|The MMRM model included terms for treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||16.95|-6.83|0.403
72597863|NCT01026818|144727125|SUPERIORITY_OR_OTHER||LS Mean Differences|11.38|STANDARD_ERROR_OF_MEAN|4.58||0.013||95.0|2.38|20.38||P-value is for Q5 - Month 9.|Mixed Models Analysis|The MMRM model included terms for treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||20.38|2.38|0.013
72597864|NCT01026818|144727125|SUPERIORITY_OR_OTHER||LS Mean Differences|3.69|STANDARD_ERROR_OF_MEAN|4.47||0.41|TWO_SIDED|95.0|-5.11|12.49||P-value is for Q5 - Month 9.|Mixed Models Analysis|The MMRM model included terms for treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||12.49|-5.11|0.410
72597865|NCT01026818|144727125|SUPERIORITY_OR_OTHER||LS Mean Differences|-2.85|STANDARD_ERROR_OF_MEAN|4.61||0.537|TWO_SIDED|95.0|-11.92|6.22||P-value is for Q5 - Month 10.5.|Mixed Models Analysis|The MMRM model included terms for treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||6.22|-11.92|0.537
72597866|NCT01026818|144727125|SUPERIORITY_OR_OTHER||LS Mean Differences|-8.59|STANDARD_ERROR_OF_MEAN|4.52||0.058|TWO_SIDED|95.0|-17.48|0.3||P-value is for Q5 - Month 10.5.|Mixed Models Analysis|The MMRM model included terms for treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||0.30|-17.48|0.058
72597867|NCT01026818|144727125|SUPERIORITY_OR_OTHER||LS Mean Differences|11.44|STANDARD_ERROR_OF_MEAN|6.09||0.061|TWO_SIDED|95.0|-0.54|23.41||P-value is for Q5 - Month 13.5.|Mixed Models Analysis|The MMRM model included terms for treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||23.41|-0.54|0.061
72597868|NCT01026818|144727125|SUPERIORITY_OR_OTHER||LS Mean Differences|5.59|STANDARD_ERROR_OF_MEAN|6.01||0.353|TWO_SIDED|95.0|-6.23|17.4||P-value is for Q5 - Month 13.5.|Mixed Models Analysis|The MMRM model included terms for treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||17.40|-6.23|0.353
72597869|NCT01026818|144727126|SUPERIORITY_OR_OTHER||LS Mean Differences|-5.12|STANDARD_ERROR_OF_MEAN|3.66||0.162|TWO_SIDED|95.0|-12.32|2.08|||ANCOVA|ANCOVA model included treatment, baseline, age group, and country.||||2.08|-12.32|0.162
72597870|NCT01026818|144727126|SUPERIORITY_OR_OTHER||LS Mean Differences|-1.88|STANDARD_ERROR_OF_MEAN|3.61||0.603||95.0|-8.99|5.24|||ANCOVA|ANCOVA model included treatment, baseline, age group, and country.||||5.24|-8.99|0.603
72597871|NCT01026818|144727130|SUPERIORITY_OR_OTHER||LS Mean Differences|3.49|STANDARD_ERROR_OF_MEAN|2.7||0.196|TWO_SIDED|95.0|-1.82|8.8||P-value is for Urinary Incontinence - Month 9.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||8.80|-1.82|0.196
72597872|NCT01026818|144727130|SUPERIORITY_OR_OTHER||LS Mean Differences|0.53|STANDARD_ERROR_OF_MEAN|2.65||0.841|TWO_SIDED|95.0|-4.69|5.75||P-value is for Urinary Incontinence - Month 9.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||5.75|-4.69|0.841
72597873|NCT01026818|144727130|SUPERIORITY_OR_OTHER||LS Mean Differences|1.98|STANDARD_ERROR_OF_MEAN|2.76||0.474|TWO_SIDED|95.0|-3.45|7.4||P-value is for Urinary Incontinence - Month 13.5.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||7.40|-3.45|0.474
72597874|NCT01026818|144727130|SUPERIORITY_OR_OTHER||LS Mean Differences|0.1|STANDARD_ERROR_OF_MEAN|2.7||0.971|TWO_SIDED|95.0|-5.21|5.41||P-value is for Urinary Incontinence - Month 13.5.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||5.41|-5.21|0.971
72597875|NCT01026818|144727130|SUPERIORITY_OR_OTHER||LS Mean Differences|1.57|STANDARD_ERROR_OF_MEAN|1.32||0.236|TWO_SIDED|95.0|-1.03|4.17||P-value is for Urinary Irritative/Obstructive - Month 9.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||4.17|-1.03|0.236
72597876|NCT01026818|144727130|SUPERIORITY_OR_OTHER||LS Mean Differences|1.02|STANDARD_ERROR_OF_MEAN|1.29||0.429|TWO_SIDED|95.0|-1.52|3.56||P-value is for Urinary Irritative/Obstructive - Month 9.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||3.56|-1.52|0.429
72597877|NCT01026818|144727130|SUPERIORITY_OR_OTHER||LS Mean Differences|1.56|STANDARD_ERROR_OF_MEAN|1.36||0.252|TWO_SIDED|95.0|-1.12|4.24||P-value is for Urinary Irritative/Obstructive - Month 13.5.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||4.24|-1.12|0.252
72597878|NCT01026818|144727130|SUPERIORITY_OR_OTHER||LS Mean Differences|1.52|STANDARD_ERROR_OF_MEAN|1.32||0.251|TWO_SIDED|95.0|-1.08|4.11||P-value is for Urinary Irritative/Obstructive - Month 13.5.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||4.11|-1.08|0.251
72597879|NCT01026818|144727130|SUPERIORITY_OR_OTHER||LS Mean Differences|-0.54|STANDARD_ERROR_OF_MEAN|1.27||0.671|TWO_SIDED|95.0|-3.03|1.95||P-value is for Bowel - Month 9.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||1.95|-3.03|0.671
72597880|NCT01026818|144727130|SUPERIORITY_OR_OTHER||LS Mean Differences|-0.21|STANDARD_ERROR_OF_MEAN|1.24||0.868|TWO_SIDED|95.0|-2.64|2.23||P-value is for Bowel - Month 9.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||2.23|-2.64|0.868
72597881|NCT01026818|144727130|SUPERIORITY_OR_OTHER||LS Mean Differences|0.1|STANDARD_ERROR_OF_MEAN|1.25||0.938|TWO_SIDED|95.0|-2.37|2.57||P-value is for Bowel - Month 13.5.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||2.57|-2.37|0.938
72415752|NCT00833638|144342419|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.24|||<|0.001|TWO_SIDED|95.0|6.42|22.06||No adjustment for multiplicity.|ANCOVA|Included were terms for baseline value of the efficacy variable, treatment, site, and the baseline-by-treatment interaction.||"Tested was the null-hypothesis that no differences in the percentages of participants who answered yes to the sexual encounter profile diary question number 4 exist between participants who received placebo and participants who received tadalafil 2.5 mg."||22.06|6.42|<0.001
72415753|NCT00833638|144342419|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|21.81|||<|0.001|TWO_SIDED|95.0|13.94|29.67||No adjustment for multiplicity.|ANCOVA|Included were terms for baseline value of the efficacy variable, treatment, site, and the baseline-by-treatment interaction.||"Tested was the null-hypothesis that no differences in the percentages of participants who answered yes to the sexual encounter profile diary question number 4 exist between participants who received placebo and participants who received tadalafil 5 mg."||29.67|13.94|<0.001
72415754|NCT00833638|144342420|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.92|||<|0.001|TWO_SIDED|95.0|6.3|21.55||No adjustment for multiplicity.|ANCOVA|Included were terms for baseline value of the efficacy variable, treatment, site, and the baseline-by-treatment interaction.||"Tested was the null-hypothesis that no differences in the percentages of participants who answered yes to the sexual encounter profile diary question number 5 exist between participants who received placebo and participants who received tadalafil 2.5 mg."||21.55|6.30|<0.001
72415755|NCT00833638|144342420|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|19.07|||<|0.001|TWO_SIDED|95.0|11.4|26.75||No adjustment for multiplicity.|ANCOVA|Included were terms for baseline value of the efficacy variable, treatment, site, and the baseline-by-treatment interaction.||"Tested was the null-hypothesis that no differences in the percentages of participants who answered yes to the sexual encounter profile diary question number 5 exist between participants who received placebo and participants who received tadalafil 5 mg."||26.75|11.40|<0.001
72415756|NCT00833638|144342421|SUPERIORITY_OR_OTHER|||||||0.301||95.0||||No adjustment for multiplicity.|Log Rank|||"Tested was the null-hypothesis that no differences in the time to onset of efficacy exists between participants who received placebo and participants who received tadalafil 2.5 mg, measured by a response of yes to the sexual encounter profile diary question number 3."||||0.301
72415757|NCT00833638|144342421|SUPERIORITY_OR_OTHER|||||||0.046||95.0||||No adjustment for multiplicity.|Log Rank|||"Tested was the null-hypothesis that no differences in the time to onset of efficacy exists between participants who received placebo and participants who received tadalafil 5 mg, measured by a response of yes to the sexual encounter profile diary question number 3."||||0.046
72415758|NCT00833638|144342422|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for day \<=14. No adjustment for multiplicity.|Regression, Logistic|Response = Treatment + Pooled Site + Severity of ED at Baseline.||"Tested was the null-hypothesis that no differences in the precentage of successful intercourse attempts exists between participants who received placebo and participants who received tadalafil 2.5 mg, measured by a response of yes to the sexual encounter profile diary question number 3."||||<0.001
72597882|NCT01026818|144727130|SUPERIORITY_OR_OTHER||LS Mean Differences|-0.29|STANDARD_ERROR_OF_MEAN|1.22||0.813|TWO_SIDED|95.0|-2.69|2.12||P-value is for Bowel - Month 13.5.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||2.12|-2.69|0.813
72597883|NCT01026818|144727130|SUPERIORITY_OR_OTHER||LS Mean Differences|9.55|STANDARD_ERROR_OF_MEAN|3.28||0.004|TWO_SIDED|95.0|3.1|15.99||P-value is for Sexual - Month 9.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||15.99|3.10|0.004
72415759|NCT00833638|144342422|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for day \<=13. No adjustment for multiplicity.|Regression, Logistic|Response = Treatment + Pooled Site + Severity of ED at Baseline.||"Tested was the null-hypothesis that no differences in the precentage of successful intercourse attempts exists between participants who received placebo and participants who received tadalafil 2.5 mg, measured by a response of yes to the sexual encounter profile diary question number 3."||||<0.001
72415760|NCT00833638|144342422|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for day \<=12. No adjustment for multiplicity.|Regression, Logistic|Response = Treatment + Pooled Site + Severity of ED at Baseline.||"Tested was the null-hypothesis that no differences in the precentage of successful intercourse attempts exists between participants who received placebo and participants who received tadalafil 2.5 mg, measured by a response of yes to the sexual encounter profile diary question number 3."||||<0.001
72597884|NCT01026818|144727130|SUPERIORITY_OR_OTHER||LS Mean Differences|2.69|STANDARD_ERROR_OF_MEAN|3.21||0.403|TWO_SIDED|95.0|-3.63|9.0||P-value is for Sexual - Month 9.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||9.00|-3.63|0.403
72597885|NCT01026818|144727130|SUPERIORITY_OR_OTHER||LS Mean Differences|3.18|STANDARD_ERROR_OF_MEAN|3.82||0.406|TWO_SIDED|95.0|-4.34|10.69||P-value is for Sexual - Month 13.5.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||10.69|-4.34|0.406
72597886|NCT01026818|144727130|SUPERIORITY_OR_OTHER||LS Mean Differences|-0.79|STANDARD_ERROR_OF_MEAN|3.72||0.832|TWO_SIDED|95.0|-8.11|6.53||P-value is for Sexual - Month 13.5.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||6.53|-8.11|0.832
72597887|NCT01026818|144727130|SUPERIORITY_OR_OTHER||LS Mean Differences|1.9|STANDARD_ERROR_OF_MEAN|1.47||0.197|TWO_SIDED|95.0|-0.99|4.79||P-value is for Hormonal - Month 9.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||4.79|-0.99|0.197
72597888|NCT01026818|144727130|SUPERIORITY_OR_OTHER||LS Mean Differences|2.89|STANDARD_ERROR_OF_MEAN|1.44||0.045|TWO_SIDED|95.0|0.06|5.72||P-value is for Hormonal - Month 9.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||5.72|0.06|0.045
72597889|NCT01026818|144727130|SUPERIORITY_OR_OTHER||LS Mean Differences|-0.53|STANDARD_ERROR_OF_MEAN|1.34||0.692|TWO_SIDED|95.0|-3.16|2.1||P-value is for Hormonal - Month 13.5.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||2.10|-3.16|0.692
72597890|NCT01026818|144727130|SUPERIORITY_OR_OTHER||LS Mean Differences|-0.09|STANDARD_ERROR_OF_MEAN|1.3||0.943|TWO_SIDED|95.0|-2.65|2.46||P-value is for Hormonal - Month 13.5.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||2.46|-2.65|0.943
72597891|NCT01026818|144727131|SUPERIORITY_OR_OTHER||LS Mean Differences|4.2|STANDARD_ERROR_OF_MEAN|1.89||0.028|TWO_SIDED|95.0|0.47|7.93||P-value is for length.|ANCOVA|ANCOVA model included terms for treatment, baseline, age group and country.||||7.93|0.47|0.028
72597892|NCT01026818|144727131|SUPERIORITY_OR_OTHER||LS Mean Differences|-1.53|STANDARD_ERROR_OF_MEAN|1.87||0.413|TWO_SIDED|95.0|-5.2|2.14||P-value is for length.|ANCOVA|ANCOVA model included terms for treatment, baseline, age group and country.||||2.14|-5.20|0.413
72597893|NCT01026818|144727131|SUPERIORITY_OR_OTHER||LS Mean Differences|2.37|STANDARD_ERROR_OF_MEAN|1.49||0.112|TWO_SIDED|95.0|-0.55|5.3||P-value is for girth.|ANCOVA|ANCOVA model included terms for treatment, baseline, age group and country.||||5.30|-0.55|0.112
72597894|NCT01026818|144727131|SUPERIORITY_OR_OTHER||LS Mean Differences|3.16|STANDARD_ERROR_OF_MEAN|1.46||0.031|TWO_SIDED|95.0|0.29|6.03||P-value is for girth.|ANCOVA|ANCOVA model included terms for treatment, baseline, age group and country.||||6.03|0.29|0.031
72597895|NCT01760447|144727132|SUPERIORITY||Least Squares Mean Difference|-0.49|||=|0.018|TWO_SIDED|95.0|-0.9|-0.09|||Mixed Models Analysis|||"The Least Squares (LS) Mean for the arm Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled is compared against that of Metformin and Metformin XR Pooled."||-0.09|-0.90|= 0.018
72597896|NCT01760447|144727133|OTHER||Difference in Percentage|-1.3|||||TWO_SIDED|95.0|-13.9|11.3|||||The Miettinen and Nurminen methodology was used to calculate the difference and 95% confidence interval.|"The percentage of participants who experienced ≥1 adverse event for the arm Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled is compared against that of Metformin and Metformin XR Pooled."||11.3|-13.9|
72597897|NCT01760447|144727134|OTHER||Difference in Percentage|-0.5|||||TWO_SIDED|95.0|-6.2|5.0|||||The Miettinen and Nurminen methodology was used to calculate the difference and 95% confidence interval.|"The percentage of participants who discontinued study drug due to experiencing an adverse event for the arm Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled is compared against that of Metformin and Metformin XR Pooled."||5.0|-6.2|
72597898|NCT01760447|144727135|OTHER||Difference in Percentage|2.9|||||TWO_SIDED|95.0|-8.9|14.4|||||The Miettinen and Nurminen methodology was used to calculate the difference and 95% confidence interval.|"The percentage of participants who experienced ≥1 adverse event for the arm Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled is compared against that of Metformin and Metformin XR Pooled."||14.4|-8.9|
72597899|NCT01760447|144727136|OTHER||Difference in Percentage|-2.1|||||TWO_SIDED|95.0|-10.1|5.8|||||The Miettinen and Nurminen methodology was used to calculate the difference and 95% confidence interval.|"The percentage of participants who discontinued study drug due to experiencing an adverse event for the arm Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled is compared against that of Metformin and Metformin XR Pooled."||5.8|-10.1|
72597900|NCT01760447|144727138|SUPERIORITY||Least Squares Mean Difference|-10.8|||=|0.159|TWO_SIDED|95.0|-25.9|4.3|||Mixed Models Analysis|||"The Least Squares (LS) Mean for the arm Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled is compared against that of Metformin and Metformin XR Pooled."||4.3|-25.9|= 0.159
72597901|NCT01760447|144727140|SUPERIORITY||Difference in Percentage|16.0||||0.017|TWO_SIDED|95.0|2.9|28.9|||Miettinen and Nurminen|||"The percentage of participants with A1C at the A1C goal (\<7.0%) in the arm Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled is compared against that of Metformin and Metformin XR Pooled. For estimating the treatment difference, when the A1C result for a participant at Week 20 was not available, a multiple imputation method was used to impute whether the participant had met the goal."||28.9|2.9|0.017
72597902|NCT01760447|144727141|SUPERIORITY||Difference in Percentage|12.2||||0.049|TWO_SIDED|95.0|0.0|24.8|||Miettinen and Nurminen|||"The percentage of participants with A1C at the A1C goal (\<6.5%) in the arm Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled is compared against that of Metformin and Metformin XR Pooled. For estimating the treatment difference, when the A1C result for a participant at Week 20 was not available, a multiple imputation method was used to impute whether the participant had met the goal."||24.8|0.0|0.049
72597903|NCT01760447|144727144|SUPERIORITY||Kaplan-Meier Difference in Percentage|-13.2||||0.002|TWO_SIDED|95.0|-21.1|-5.3|||Log-Rank Test|||"The percentage of participants initiating glycemic rescue therapy in the arm Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled is compared against that of Metformin and Metformin XR Pooled."||-5.3|-21.1|0.002
72415761|NCT00833638|144342422|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for day \<=11. No adjustment for multiplicity.|Regression, Logistic|Response = Treatment + Pooled Site + Severity of ED at Baseline.||"Tested was the null-hypothesis that no differences in the precentage of successful intercourse attempts exists between participants who received placebo and participants who received tadalafil 2.5 mg, measured by a response of yes to the sexual encounter profile diary question number 3."||||<0.001
72597904|NCT02815267|144727157|SUPERIORITY||Mean Difference (Final Values)|2.8|STANDARD_ERROR_OF_MEAN|1.06||0.0083|TWO_SIDED|95.0|0.72|4.88|||ANCOVA|||Change from baseline in inflammatory lesion count was analyzed using an analysis of covariance (ANCOVA) model, which included treatment, Baseline inflammatory lesion count and pooled investigational site as a blocking factor.||4.88|0.72|0.0083
72597905|NCT02815267|144727158|SUPERIORITY||Risk Difference (RD)|3.33|STANDARD_ERROR_OF_MEAN|2.48||0.1805|TWO_SIDED|95.0|-1.54|8.19||P-value is for the null hypothesis that the combined risk difference equals 0.|Cochran-Mantel-Haenszel|||||8.19|-1.54|0.1805
72597906|NCT02815267|144727159|SUPERIORITY|Percent change from baseline was analyzed using an ANCOVA model, which included treatment, baseline non-inflammatory lesion counts and pooled investigational site as a blocking factor. For the superiority comparison between FMX101 4% and vehicle.|Mean Difference (Final Values)|12.73|STANDARD_ERROR_OF_MEAN|4.42||0.004|TWO_SIDED|95.0|4.07|21.39|||ANCOVA|||||21.39|4.07|0.0040
72597907|NCT02815267|144727160|SUPERIORITY|Change from baseline in inflammatory lesion count for Week 6 was analyzed using an ANCOVA model, which included treatment, baseline inflammatory lesion counts and pooled investigational site as a blocking factor.|Mean Difference (Final Values)|3.86|STANDARD_ERROR_OF_MEAN|1.03||0.0002|TWO_SIDED|95.0|1.85|5.87|||ANCOVA|||||5.87|1.85|0.0002
72597908|NCT02815267|144727160|SUPERIORITY|Change from baseline in inflammatory lesion count for Week 9 was analyzed using an ANCOVA model, which included treatment, baseline inflammatory lesion counts and pooled investigational site as a blocking factor.|Mean Difference (Final Values)|4.39|STANDARD_ERROR_OF_MEAN|1.03|<|0.0001|TWO_SIDED|95.0|2.38|6.4|||ANCOVA|||||6.40|2.38|<.0001
72597909|NCT02815267|144727161|SUPERIORITY|P-value is for null hypothesis that the combined risk difference equals 0. Percentage of participants achieving IGA treatment success at Week 6|Risk Difference (RD)|2.71|STANDARD_ERROR_OF_MEAN|1.32||0.0395|TWO_SIDED|95.0|0.13|5.3|||Cochran-Mantel-Haenszel|||||5.3|0.13|0.0395
72597910|NCT02815267|144727161|SUPERIORITY|P-value is for null hypothesis that the combined risk difference equals 0. Percentage of participants achieving IGA treatment success at Week 9.|Risk Difference (RD)|2.76|STANDARD_ERROR_OF_MEAN|1.55||0.0748|TWO_SIDED|95.0|-0.28|5.8|||Cochran-Mantel-Haenszel|||||5.80|-0.28|0.0748
72597911|NCT04278924|144727193|SUPERIORITY||Risk Difference (RD)|43.59|||=|0.056|TWO_SIDED|95.0|0.81|73.35|||Barnard's test||95% confidence interval (CI) of the difference in percentage was calculated using Miettinen-Nurminen method.|||73.35|0.81|=0.056
72597912|NCT04278924|144727193|SUPERIORITY||Risk Difference (RD)|39.42|||=|0.088|TWO_SIDED|95.0|-4.24|71.38|||Barnard's test||95% CI of the difference in percentage was calculated using Miettinen-Nurminen method.|||71.38|-4.24|=0.088
72597913|NCT04278924|144727193|SUPERIORITY||Risk Difference (RD)|67.83|||=|0.001|TWO_SIDED|95.0|29.21|87.29|||Barnard's test||95% CI of the difference in percentage was calculated using Miettinen-Nurminen method.|||87.29|29.21|=0.001
72597914|NCT04278924|144727194|SUPERIORITY||Risk Difference (RD)|55.56|||=|0.001|TWO_SIDED|95.0|25.11|81.51|||Barnard's test||95% CI of the difference in percentage was calculated using Miettinen-Nurminen method.|||81.51|25.11|=0.001
72597915|NCT04278924|144727194|SUPERIORITY||Risk Difference (RD)|50.0|||=|0.004|TWO_SIDED|95.0|19.63|78.95|||Barnard's test||95% CI of the difference in percentage was calculated using Miettinen-Nurminen method.|||78.95|19.63|=0.004
72597916|NCT04278924|144727194|SUPERIORITY||Risk Difference (RD)|81.82|||<|0.001|TWO_SIDED|95.0|51.24|94.99|||Barnard's test||95% CI of the difference in percentage was calculated using Miettinen-Nurminen method.|||94.99|51.24|<0.001
72597917|NCT04278924|144727195|SUPERIORITY||Risk Difference (RD)|35.9|||=|0.12|TWO_SIDED|95.0|-7.22|67.75|||Barnard's test||95% CI of the difference in percentage was calculated using Miettinen-Nurminen method.|||67.75|-7.22|=0.120
72597918|NCT04278924|144727195|SUPERIORITY||Risk Difference (RD)|44.23|||=|0.06|TWO_SIDED|95.0|-0.83|73.77|||Barnard's test||95% CI of the difference in percentage was calculated using Miettinen-Nurminen method.|||73.77|-0.83|=0.060
72597919|NCT04278924|144727195|SUPERIORITY||Risk Difference (RD)|60.14|||=|0.003|TWO_SIDED|95.0|21.33|82.42|||Barnard's test||95% CI of the difference in percentage was calculated using Miettinen-Nurminen method.|||82.42|21.33|=0.003
72597920|NCT04278924|144727196|SUPERIORITY||Risk Difference (RD)|40.0|||=|0.187|TWO_SIDED|95.0|-16.28|78.17|||Barnard's test||95% CI of the difference in percentage was calculated using Miettinen-Nurminen method.|||78.17|-16.28|=0.187
72597921|NCT04278924|144727196|SUPERIORITY||Risk Difference (RD)|25.0|||=|0.315|TWO_SIDED|95.0|-28.85|71.78|||Barnard's test||95% CI of the difference in percentage was calculated using Miettinen-Nurminen method.|||71.78|-28.85|=0.315
72597922|NCT04278924|144727196|SUPERIORITY||Risk Difference (RD)|100.0|||=|0.004|TWO_SIDED|95.0|35.12|100.0|||Barnard's test||95% CI of the difference in percentage was calculated using Miettinen-Nurminen method.|||100.00|35.12|=0.004
72597923|NCT05600036|144727197|SUPERIORITY|||||||0.0025|||||||Cochran-Mantel-Haenszel|||||||0.0025
72597924|NCT05600036|144727197|SUPERIORITY|||||||0.0001|||||||Cochran-Mantel-Haenszel|||||||0.0001
72597925|NCT05600036|144727197|SUPERIORITY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
72597926|NCT05600036|144727197|SUPERIORITY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
72597927|NCT05600036|144727197|SUPERIORITY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
72415762|NCT00833638|144342422|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for day \<=10. No adjustment for multiplicity.|Regression, Logistic|Response = Treatment + Pooled Site + Severity of ED at Baseline.||"Tested was the null-hypothesis that no differences in the precentage of successful intercourse attempts exists between participants who received placebo and participants who received tadalafil 2.5 mg, measured by a response of yes to the sexual encounter profile diary question number 3."||||<0.001
72415763|NCT00833638|144342422|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for day \<=9. No adjustment for multiplicity.|Regression, Logistic|Response = Treatment + Pooled Site + Severity of ED at Baseline.||"Tested was the null-hypothesis that no differences in the precentage of successful intercourse attempts exists between participants who received placebo and participants who received tadalafil 2.5 mg, measured by a response of yes to the sexual encounter profile diary question number 3."||||<0.001
72415764|NCT00833638|144342422|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||P-value for day \<=8. No adjustment for multiplicity.|Regression, Logistic|Response = Treatment + Pooled Site + Severity of ED at Baseline.||"Tested was the null-hypothesis that no differences in the precentage of successful intercourse attempts exists between participants who received placebo and participants who received tadalafil 2.5 mg, measured by a response of yes to the sexual encounter profile diary question number 3."||||0.002
72597928|NCT01006590|144727201|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1|STANDARD_ERROR_OF_MEAN|0.09||0.26|TWO_SIDED|95.0|-0.26|0.07|||ANCOVA|With baseline value as covariate and treatment group as factor; comparison of LSmeans for treatment||The null hypothesis H0: µt-µC=0, where μT denotes the mean absolute change in HbA1c from baseline to Week 24 in the group of patients treated with saxagliptin (test medication, T) and μC the mean absolute change in HbA1c from baseline to Week 24 in the group of patients with uptitration of metformin (comparator, C) A sample size of 120 randomized and treated patients per treatment group yielded 80% power under the assumption of a true treatment difference of 0.4% and a standard deviation of 1.1%||0.07|-0.26|0.26
72597929|NCT01006590|144727202|SUPERIORITY_OR_OTHER||Mean Difference (Net)|5.8|STANDARD_ERROR_OF_MEAN|5.79||0.3202|TWO_SIDED|95.0|-5.6|17.1|||Regression, Logistic|||||17.1|-5.6|0.3202
72597930|NCT01006590|144727203|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.3|STANDARD_ERROR_OF_MEAN|4.58||0.6203|TWO_SIDED|95.0|-6.7|11.3|||Regression, Logistic|||||11.3|-6.7|0.6203
72597931|NCT01006590|144727204|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.07|STANDARD_ERROR_OF_MEAN|0.23||0.7627|TWO_SIDED|95.0|-0.38|0.52|||ANCOVA|||||0.52|-0.38|0.7627
72597932|NCT01006590|144727205|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.3|STANDARD_ERROR_OF_MEAN|1.19||0.7701|TWO_SIDED|95.0|-2.0|2.7|||ANCOVA|||||2.7|-2.0|0.7701
72597933|NCT01006590|144727206|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.39|STANDARD_ERROR_OF_MEAN|4.34||0.5882|TWO_SIDED|95.0|-6.22|10.93|||ANCOVA|||||10.93|-6.22|0.5882
72415765|NCT00833638|144342422|SUPERIORITY_OR_OTHER|||||||0.001||95.0||||P-value for day \<=7. No adjustment for multiplicity.|Regression, Logistic|Response = Treatment + Pooled Site + Severity of ED at Baseline.||"Tested was the null-hypothesis that no differences in the precentage of successful intercourse attempts exists between participants who received placebo and participants who received tadalafil 2.5 mg, measured by a response of yes to the sexual encounter profile diary question number 3."||||0.001
72415766|NCT00833638|144342422|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||P-value for day \<=6. No adjustment for multiplicity.|Regression, Logistic|Response = Treatment + Pooled Site + Severity of ED at Baseline.||"Tested was the null-hypothesis that no differences in the precentage of successful intercourse attempts exists between participants who received placebo and participants who received tadalafil 2.5 mg, measured by a response of yes to the sexual encounter profile diary question number 3."||||0.002
72597934|NCT00703118|144727246|SUPERIORITY_OR_OTHER||Difference in percentage of response|46.8|||<|0.001|TWO_SIDED|95.0|36.8|56.7||Overall significance level was set at 5% (two-sided). Adjustment of significance level for multiple comparisons was carried out using the Hochberg procedure|Regression, Logistic|Included: treatment, type of prior response (relapser, partial responder, null-responder) and their interaction, and baseline HCV RNA as a covariate|Difference in percentage of response was estimated through the logistic regression model.|Null hypothesis: Assuming a 55% response rate in the groups receiving Treatment T12/PR48, a 29% response rate in the group receiving Treatment Pbo/PR48, a 2-sided continuity corrected Chi-squared test, with an overall significance level of 5% and a 2:2:1 randomization, a sample size of 140 patients receiving Treatment T12/PR48 and 70 patients in receiving Treatment Pbo/PR48 provided a power of approximately 90% to demonstrate a statistically significant difference.||56.7|36.8|<0.001
72597935|NCT00703118|144727246|SUPERIORITY_OR_OTHER||Difference in percentage of response|49.8|||<|0.001|TWO_SIDED|95.0|39.9|59.7||Overall significance level was set at 5% (two-sided). Adjustment of significance level for multiple comparisons was carried out using the Hochberg procedure|Regression, Logistic|Included: treatment, type of prior response (relapser, partial responder, null-responder) and their interaction, and baseline HCV RNA as a covariate|Difference in percentage of response was estimated through the logistic regression model.|Null hypothesis: Assuming a 55% response rate in the groups receiving Treatment T12/PR48 or T12(DS)/PR48, a 29% response rate in the group receiving Treatment Pbo/PR48, a 2-sided continuity corrected Chi-squared test, with an overall significance level of 5% and a 2:2:1 randomization, a sample size of 140 patients receiving Treatment T12(DS)/PR48 and 70 patients in receiving Treatment Pbo/PR48 provided a power of approximately 90% to demonstrate a statistically significant difference.||59.7|39.9|<0.001
72597936|NCT03714776|144727256|SUPERIORITY||||||<|0.001||||||P-value of analysis of variance (ANOVA) with treatment and screening AGT concentration stratification factor was used for analysis.|ANOVA|||||||<0.001
72597937|NCT03714776|144727257|SUPERIORITY|||||||0.454||||||P-value of ANOVA with treatment and screening AGT concentration stratification factor was used for analysis.|ANOVA|||Day 3||||0.454
72597938|NCT03714776|144727257|SUPERIORITY|||||||0.909||||||P-value of ANOVA with treatment and screening AGT concentration stratification factor was used for analysis.|ANOVA|||Day 8||||0.909
72597939|NCT03714776|144727257|SUPERIORITY|||||||0.132||||||P-value of ANOVA with treatment and screening AGT concentration stratification factor was used for analysis.|ANOVA|||Day 15||||0.132
72597940|NCT03714776|144727257|SUPERIORITY|||||||0.659||||||P-value of ANOVA with treatment and screening AGT concentration stratification factor was used for analysis.|ANOVA|||Day 22||||0.659
72597941|NCT03714776|144727257|SUPERIORITY|||||||0.474||||||P-value of ANOVA with treatment and screening AGT concentration stratification factor was used for analysis.|ANOVA|||Day 29||||0.474
72597942|NCT03714776|144727257|SUPERIORITY|||||||0.483||||||P-value of ANOVA with treatment and screening AGT concentration stratification factor was used for analysis.|ANOVA|||Day 36||||0.483
72597943|NCT03714776|144727258|SUPERIORITY|||||||0.064||||||P-value of ANOVA with treatment and screening AGT concentration stratification factor was used for analysis.|ANOVA|||Day 3||||0.064
72597944|NCT03714776|144727258|SUPERIORITY||||||<|0.001||||||P-value of ANOVA with treatment and screening AGT concentration stratification factor was used for analysis.|ANOVA|||Day 8||||<0.001
72597945|NCT03714776|144727258|SUPERIORITY||||||<|0.001||||||P-value of ANOVA with treatment and screening AGT concentration stratification factor was used for analysis.|ANOVA|||Day 15||||<0.001
72597946|NCT03714776|144727258|SUPERIORITY||||||<|0.001||||||P-value of ANOVA with treatment and screening AGT concentration stratification factor was used for analysis.|ANOVA|||Day 22||||<0.001
72597947|NCT03714776|144727258|SUPERIORITY||||||<|0.001||||||P-value of ANOVA with treatment and screening AGT concentration stratification factor was used for analysis.|ANOVA|||Day 29||||<0.001
72597948|NCT03714776|144727258|SUPERIORITY||||||<|0.001||||||P-value of ANOVA with treatment and screening AGT concentration stratification factor was used for analysis.|ANOVA|||Day 36||||<0.001
72415767|NCT00833638|144342422|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||P-value for day \<=5. No adjustment for multiplicity.|Regression, Logistic|Response = Treatment + Pooled Site + Severity of ED at Baseline.||"Tested was the null-hypothesis that no differences in the precentage of successful intercourse attempts exists between participants who received placebo and participants who received tadalafil 2.5 mg, measured by a response of yes to the sexual encounter profile diary question number 3."||||0.002
72415768|NCT00833638|144342422|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||P-value for day \<=4. No adjustment for multiplicity.|Regression, Logistic|Response = Treatment + Pooled Site + Severity of ED at Baseline.||"Tested was the null-hypothesis that no differences in the precentage of successful intercourse attempts exists between participants who received placebo and participants who received tadalafil 2.5 mg, measured by a response of yes to the sexual encounter profile diary question number 3."||||0.002
72415769|NCT00833638|144342422|SUPERIORITY_OR_OTHER|||||||0.009||95.0||||P-value for day \<=3. No adjustment for multiplicity.|Regression, Logistic|Response = Treatment + Pooled Site + Severity of ED at Baseline.||"Tested was the null-hypothesis that no differences in the precentage of successful intercourse attempts exists between participants who received placebo and participants who received tadalafil 2.5 mg, measured by a response of yes to the sexual encounter profile diary question number 3."||||0.009
72415770|NCT00833638|144342422|SUPERIORITY_OR_OTHER|||||||0.038||95.0||||P-value for day \<=2. No adjustment for multiplicity.|Regression, Logistic|Response = Treatment + Pooled Site + Severity of ED at Baseline.||"Tested was the null-hypothesis that no differences in the precentage of successful intercourse attempts exists between participants who received placebo and participants who received tadalafil 2.5 mg, measured by a response of yes to the sexual encounter profile diary question number 3."||||0.038
72415771|NCT00833638|144342422|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for day \<=14. No adjustment for multiplicity.|Regression, Logistic|Response = Treatment + Pooled Site + Severity of ED at Baseline.||"Tested was the null-hypothesis that no differences in the proportion of successful intercourse attempts exists between participants who received placebo and participants who received tadalafil 5 mg, measured by a response of yes to the sexual encounter profile diary question number 3."||||<0.001
72597949|NCT00548249|144727275|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|1.0||||0.999|TWO_SIDED|95.0|0.3|3.32||p-value not adjusted for multiple comparisons|Log Rank|||Hazard ratio with 95% confidence intervals comparing each SFP treatment group to placebo, and p-value from cox proportional hazards model||3.32|0.30|0.999
72597950|NCT00548249|144727275|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|1.17||||0.807|TWO_SIDED|95.0|0.33|4.09|||Log Rank|||||4.09|0.33|0.807
72597951|NCT00548249|144727275|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|0.8||||0.748|TWO_SIDED|95.0|0.21|3.02|||Log Rank|||||3.02|0.21|0.748
72597952|NCT00548249|144727275|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|1.77||||0.299|TWO_SIDED|95.0|0.6|5.19|||Log Rank|||||5.19|0.60|0.299
72597953|NCT00548249|144727276|SUPERIORITY_OR_OTHER_LEGACY|||||||0.234||95.0||||Threshold for statistical significance p \< 0.05|ANOVA|||Each dose was compared to placebo using an ANOVA model with treatment as the effect.||||0.234
72597954|NCT00548249|144727276|SUPERIORITY_OR_OTHER_LEGACY|||||||0.049||95.0||||Threshold for statistical significance p \< 0.05|ANOVA|||Each dose was compared to placebo using an ANOVA model with treatment as the effect||||0.049
72597955|NCT00548249|144727276|SUPERIORITY_OR_OTHER_LEGACY|||||||0.375||95.0||||Threshold for statistical significance p \< 0.05|ANOVA|||Each dose was compared to placebo using an ANOVA model with treatment as the effect||||0.375
72597956|NCT00548249|144727276|SUPERIORITY_OR_OTHER_LEGACY|||||||0.625||95.0||||Threshold for statistical significance p \< 0.05|ANOVA|||Each dose was compared to placebo using an ANOVA model with treatment as the effect||||0.625
72597957|NCT03003000|144727281|SUPERIORITY||Mean Difference (Final Values)|0.156||||0.3446|TWO_SIDED|95.0|-0.168|0.48||No adjustment for multiplicity issues was made for this comparison. The level of significance was 0.05.|Mixed effect Model Repeated Measurement||Adjusted mean change from baseline ibuprofen and caffeine - Adjusted mean change from baseline placebo. A positive result favors the treatment with ibuprofen and caffeine|Superiority of ibuprofen and caffeine versus ibuprofen as well as ibuprofen and caffeine versus placebo had to be shown to reject the overall null hypothesis that there is no difference in change in POMWP between baseline and Day 2 (morning, 2 h after drug intake) between patients treated with ibuprofen/caffeine and patients treated with placebo.|Mixed effect model for repeated measures analysis (MMRM) includes fixed, categorical effects of treatment, country, worst procedure site, time and interaction terms for treatment-by-time, treatment-by-stratum-by-time, treatment-by-stratum and stratum-by-time interaction, as well as the continuous fixed covariates of baseline POMwp and baseline-by-time interaction, using unstructured covariance matrix.|0.480|-0.168|0.3446
72597958|NCT03003000|144727281|SUPERIORITY||Mean Difference (Final Values)|-0.129||||0.3358|TWO_SIDED|95.0|-0.392|0.134||No adjustment for multiplicity issues was made for this comparison. The level of significance was 0.05.|Mixed effect Model Repeat Measurement||Adjusted mean change from baseline ibuprofen and caffeine - Adjusted mean change from baseline ibuprofen. A positive result favors the treatment with ibuprofen and caffeine|Superiority of ibuprofen and caffeine versus ibuprofen as well as ibuprofen and caffeine versus placebo had to be shown to reject the overall null hypothesis that there is no difference in change in POMWP between baseline and Day 2 (morning, 2 h after drug intake) between patients treated with ibuprofen/caffeine and patients treated with ibuprofen.|Mixed effect model for repeated measures analysis (MMRM) includes fixed, categorical effects of treatment, country, worst procedure site, time and interaction terms for treatment-by-time, treatment-by-stratum-by-time, treatment-by-stratum and stratum-by-time interaction, as well as the continuous fixed covariates of baseline POMwp and baseline-by-time interaction, using unstructured covariance matrix|0.134|-0.392|0.3358
72597959|NCT03003000|144727282|SUPERIORITY||Mean Difference (Final Values)|-0.288||||0.0474|TWO_SIDED|95.0|-0.572|-0.003||No adjustment for multiplicity issues was made for this comparison. The level of significance was 0.05.|ANCOVA|ANCOVA included treatment, country, and worst procedure site as fixed effects and baseline POMwp as a continuous covariate.|Adjusted mean ibuprofen and caffeine - Adjusted mean placebo. A negative result favors ibuprofen and caffeine|||-0.003|-0.572|0.0474
72597960|NCT03003000|144727282|SUPERIORITY||Mean Difference (Final Values)|0.051||||0.6658|TWO_SIDED|95.0|-0.18|0.282||No adjustment for multiplicity issues was made for this comparison. The level of significance was 0.05.|ANCOVA|The ANCOVA included treatment, country, and worst procedure site as fixed effects and baseline POMwp as a continuous covariate.|Adjusted mean ibuprofen and caffeine - Adjusted mean ibuprofen. A negative result favors ibuprofen and caffeine.|||0.282|-0.180|0.6658
72597961|NCT03003000|144727283|SUPERIORITY||Mean Difference (Final Values)|-0.399||||0.0091|TWO_SIDED|95.0|-0.698|-0.1||No adjustment for multiplicity issues was made for this comparison. The level of significance was 0.05.|ANCOVA|The ANCOVA included treatment, country, and worst procedure site as fixed effects and baseline POMwp as a continuous covariate.|Adjusted mean ibuprofen and caffeine - Adjusted mean placebo. A negative result favors ibuprofen and caffeine|||-0.100|-0.698|0.0091
72597962|NCT03003000|144727283|SUPERIORITY||Mean Difference (Final Values)|0.058||||0.6387|TWO_SIDED|95.0|-0.185|0.302||No adjustment for multiplicity issues was made for this comparison. The level of significance was 0.05.|ANCOVA|The ANCOVA included treatment, country, and worst procedure site as fixed effects and baseline POMwp as a continuous covariate.|Adjusted mean ibuprofen and caffeine - Adjusted mean ibuprofen. A negative result favors ibuprofen and caffeine|||0.302|-0.185|0.6387
72597963|NCT03003000|144727284|SUPERIORITY||Mean Difference (Final Values)|0.559||||0.4398|TWO_SIDED|95.0|-0.861|1.979||No adjustment for multiplicity issues was made for this comparison. The level of significance was 0.05.|Mixed effect model for repeated measures||Adjusted mean change ibuprofen and caffeine - Adjusted mean change placebo. A negative result favors ibuprofen and caffeine.|Mixed effect model for repeated measures (MMRM) includes fixed, categorical effects of treatment, country, worst procedure site, time and interaction terms for treatment-by-time as well as the continuous fixed covariates of baseline pressure algometry and baseline-by-time interaction, using unstructured covariance matrix.||1.979|-0.861|0.4398
72597964|NCT03003000|144727284|SUPERIORITY||Mean Difference (Final Values)|0.156||||0.7911|TWO_SIDED|95.0|-1.002|1.314||No adjustment for multiplicity issues was made for this comparison. The level of significance was 0.05.|Mixed effect Model Repeat Measurement||Adjusted mean change ibuprofen and caffeine - Adjusted mean change ibuprofen. A negative result favors ibuprofen and caffeine.|MMRM includes fixed, categorical effects of treatment, country, worst procedure site, time and interaction terms for treatment-by-time as well as the continuous fixed covariates of baseline pressure algometry and baseline-by-time interaction, using unstructured covariance matrix.||1.314|-1.002|0.7911
72597965|NCT03003000|144727285|SUPERIORITY||Odds Ratio (OR)|1.777||||0.0045|TWO_SIDED|95.0|1.195|2.642||No adjustment for multiplicity issues was made for this comparison. The level of significance was 0.05.|Regression, Logistic|An ordinal logistic regression model adjusting for country and worst procedure site.|An odds ratio \>1 indicates better efficacy for ibuprofen and caffeine than for the comparator|||2.642|1.195|0.0045
72597966|NCT03003000|144727285|SUPERIORITY||Odds Ratio (OR)|1.008||||0.9603|TWO_SIDED|95.0|0.732|1.389||No adjustment for multiplicity issues was made for this comparison. The level of significance was 0.05.|Regression, Logistic|An ordinal logistic regression model adjusting for country and worst procedure site.|An odds ratio \>1 indicates better efficacy for ibuprofen and caffeine than for the comparator|||1.389|0.732|0.9603
72597967|NCT03003000|144727286|SUPERIORITY||Odds Ratio (OR)|1.028||||0.9022|TWO_SIDED|95.0|0.663|1.592||No adjustment for multiplicity issues was made for this comparison. The level of significance was 0.05.|likelihood-ratio test|The likelihood-ratio test was used to test treatment differences for patients with a decrease of ≥30%.|An odds ratio \>1 indicates better efficacy for ibuprofen and caffeine than for the comparator.||Results are based on the Logistic regression. Logistic regression model was adjusted for the categorical covariates country and worst procedure site.|1.592|0.663|0.9022
72597968|NCT03003000|144727286|SUPERIORITY||Odds Ratio (OR)|0.834||||0.3129|TWO_SIDED|95.0|0.586|1.187||No adjustment for multiplicity issues was made for this comparison. The level of significance was 0.05.|likelihood-ratio test|The likelihood-ratio test was used to test treatment differences for patients with a decrease of ≥30%.|An odds ratio \>1 indicates better efficacy for ibuprofen and caffeine than for the comparator.||Results are based on the Logistic regression. Logistic regression model was adjusted for the categorical covariates country and worst procedure site.|1.187|0.586|0.3129
72597969|NCT03003000|144727286|SUPERIORITY||Odds Ratio (OR)|1.354||||0.3301|TWO_SIDED|95.0|0.736|2.494||No adjustment for multiplicity issues was made for this comparison. The level of significance was 0.05.|likelihood-ratio test|The likelihood-ratio test was used to test treatment differences for patients with a decrease of ≥50%.|An odds ratio \>1 indicates better efficacy for ibuprofen and caffeine than for the comparator||Results are based on the Logistic regression. Logistic regression model was adjusted for the categorical covariates country and worst procedure site.|2.494|0.736|0.3301
72597970|NCT03003000|144727286|SUPERIORITY||Odds Ratio (OR)|0.68||||0.0864|TWO_SIDED|95.0|0.437|1.057||No adjustment for multiplicity issues was made for this comparison. The level of significance was 0.05.|likelihood-ratio test|The likelihood-ratio test was used to test treatment differences for patients with a decrease of ≥50%.|An odds ratio \>1 indicates better efficacy for ibuprofen and caffeine than for the comparator||Results are based on the Logistic regression. Logistic regression model was adjusted for the categorical covariates country and worst procedure site.|1.057|0.437|0.0864
72597971|NCT03003000|144727287|SUPERIORITY|||||||0.9384||||||No adjustment for multiplicity issues was made for this comparison. The level of significance was 0.05.|Log Rank|p-value based on a stratified log-rank test||||||0.9384
72597972|NCT03003000|144727287|SUPERIORITY|||||||0.3534||||||No adjustment for multiplicity issues was made for this comparison. The level of significance was 0.05.|Log Rank|p-value based on a stratified log-rank test||||||0.3534
72597973|NCT02191046|144727303|NON_INFERIORITY_OR_EQUIVALENCE|power of study = 90%|Mean Difference (Final Values)|4.38|STANDARD_DEVIATION|2.89|<|0.05|TWO_SIDED|95.0|3.41|5.37|||t-test, 2 sided|||compare the mean 5S-score between before and after treatment in syringe group||5.37|3.41|<0.05
72597974|NCT02191046|144727303|NON_INFERIORITY_OR_EQUIVALENCE|power of study = 90%|Mean Difference (Net)|0.93|STANDARD_DEVIATION|0.42|<|0.05|TWO_SIDED|95.0|0.094|1.76|||t-test, 2 sided|||compare the mean 5S-score between 2 groups at 2 weeks after treatment||1.76|0.094|<0.05
72597975|NCT02191046|144727303|NON_INFERIORITY_OR_EQUIVALENCE|power of study = 90%|Mean Difference (Net)|-0.47|STANDARD_DEVIATION|0.17|<|0.05|TWO_SIDED|95.0|-0.82|-0.12|||t-test, 2 sided|||satisfaction score between two groups at 2 weeks after treatment||-0.12|-0.82|<0.05
72597976|NCT02191046|144727303|NON_INFERIORITY_OR_EQUIVALENCE|power fo study = 90%|Mean Difference (Final Values)|5.66|STANDARD_DEVIATION|3.16|<|0.05|TWO_SIDED|95.0|4.62|6.69|||t-test, 2 sided|||compare the mean 5s-score between before and after treatment in squeezable bottle group||6.69|4.62|<0.05
72597977|NCT04006509|144727355|SUPERIORITY|||||||0.985|||||||Wilcoxon (Mann-Whitney)|||||||0.985
72597978|NCT04006509|144727356|SUPERIORITY|||||||0.539|||||||Marginal Two-Part Model|||||||0.539
72597979|NCT04006509|144727357|SUPERIORITY|||||||0.959|||||||Wilcoxon (Mann-Whitney)|||||||0.959
72597980|NCT04006509|144727358|SUPERIORITY|||||||0.743|||||||Marginal Two-Part Model|||||||0.743
72597981|NCT04006509|144727359|SUPERIORITY|||||||0.886|||||||Marginalized Two-Part Model|||||||0.886
72597982|NCT04006509|144727360|SUPERIORITY|||||||0.107|||||||Marginalized Two-Part Model|||||||0.107
72597983|NCT04006509|144727361|SUPERIORITY|||||||0.687|||||||Marginalized Two-Part Model|||||||0.687
72597984|NCT04006509|144727362|SUPERIORITY|||||||0.871|||||||Marginalized Two-Part Model|||||||0.871
72597985|NCT04006509|144727363|SUPERIORITY|||||||0.376|||||||Marginalized Two-Part Model|||||||0.376
72597986|NCT04006509|144727364|SUPERIORITY|||||||0.77|||||||Marginalized Two-Part Model|||||||0.770
72597987|NCT04006509|144727365|SUPERIORITY|||||||0.237|||||||Marginalized Two-Part Model|||||||0.237
72597988|NCT02759835|144727378|OTHER|||||||0.56|||||||Kaplan-Meier|||||||0.56
72597989|NCT02759835|144727380|OTHER|||||||0.4|||||||Kaplan-Meier|||||||0.40
72597990|NCT00002525|144727392|SUPERIORITY_OR_OTHER_LEGACY|||||||0.178||||||one-sided log-rank test p value|Log Rank|||||||0.178
72597991|NCT00002525|144727393|SUPERIORITY_OR_OTHER_LEGACY|||||||0.847||||||two-sided log rank test|Log Rank|||||||0.847
72597992|NCT04475718|144727396|OTHER|Preliminary Efficacy|||||<|0.001|||||||t-test, 2 sided|||||||<.001
72415772|NCT00833638|144342422|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for day \<=13. No adjustment for multiplicity.|Regression, Logistic|Response = Treatment + Pooled Site + Severity of ED at Baseline.||"Tested was the null-hypothesis that no differences in the precentage of successful intercourse attempts exists between participants who received placebo and participants who received tadalafil 5 mg, measured by a response of yes to the sexual encounter profile diary question number 3."||||<0.001
72597993|NCT03230838|144727401|OTHER|The Miettinen \& Nurminen method was used.|Percentage Difference|-1.6|||||TWO_SIDED|95.0|-19.7|17.9|||||Ceftolozane/Tazobactam (C/T) minus Meropenem (Mero)|Difference in Percentage (C/T minus Mero)||17.9|-19.7|
72597994|NCT03230838|144727402|OTHER|The Miettinen \& Nurminen method was used.|Percentage Difference|1.0|||||TWO_SIDED|95.0|-9.5|5.5|||||C/T minus Mero|Difference in Percentage (C/T minus Mero)||5.5|-9.5|
72597995|NCT03230838|144727403|OTHER|The Miettinen \& Nurminen method stratified by age group with Cochran- Mantel-Haenszel (CMH) weights was used. If there was a zero count in any class of the stratum, the groups with the lower count were pooled with its near age group stratum in the model.|Percentage Difference|-7.3|||||TWO_SIDED|95.0|-17.99|10.05|||||C/T minus Mero|Difference in Percentage (C/T minus Mero)||10.05|-17.99|
72597996|NCT03230838|144727404|OTHER|The Miettinen \& Nurminen method stratified by age group with Cochran- Mantel-Haenszel (CMH) weights was used. If there was a zero count in any class of the stratum, the groups with the lower count were pooled with its near age group stratum in the model.|Percentage Difference|-5.6|||||TWO_SIDED|95.0|-14.09|8.88|||||C/T minus Mero|Difference in Percentage (C/T minus Mero)||8.88|-14.09|
72597997|NCT03230838|144727405|OTHER|The Miettinen \& Nurminen method stratified by age group with Cochran- Mantel-Haenszel (CMH) weights was used. If there was a zero count in any class of the stratum, the groups with the lower count were pooled with its near age group stratum in the model.|Percentage Difference|-3.0|||||TWO_SIDED|95.0|-17.13|17.4|||||C/T minus Mero|Difference in Percentage (C/T minus Mero)||17.40|-17.13|
72597998|NCT03230838|144727406|OTHER|The Miettinen \& Nurminen method stratified by age group with CMH weights was used. If there was a zero count in any class of the stratum, the groups with the lower count were pooled with its near age group stratum in the model.|Percentage Difference|-3.4|||||TWO_SIDED|95.0|-12.67|13.41|||||C/T minus Mero|Difference in Percentage (C/T minus Mero)||13.41|-12.67|
72597999|NCT01505179|144727407|SUPERIORITY|||||||0.47|||||||t-test, 2 sided|||||||0.47
72598000|NCT01505179|144727408|SUPERIORITY|||||||0.009|||||||Wilcoxon (Mann-Whitney)|||||||0.009
72598001|NCT01505179|144727409|SUPERIORITY|||||||0.74|||||||t-test, 2 sided|||||||0.74
72598002|NCT01505179|144727410|SUPERIORITY|||||||0.49|||||||Wilcoxon (Mann-Whitney)|||||||0.49
72598003|NCT02697734|144727436|SUPERIORITY||Odds Ratio (OR)|43.4|||<|0.0001|TWO_SIDED|95.0|7.06|343.19|||Cochran-Mantel-Haenszel|||||343.19|7.06|<.0001
72598004|NCT02651688|144727473|SUPERIORITY|||||||0.7103|||||||Wilcoxon rank-sum test|||||||0.7103
72598005|NCT02651688|144727473|SUPERIORITY|||||||0.4529|||||||Wilcoxon rank-sum test|||||||0.4529
72598006|NCT02651688|144727474|SUPERIORITY|||||||0.9302|||||||Wilcoxon rank-sum test|||||||0.9302
72598007|NCT02651688|144727474|SUPERIORITY|||||||0.7509|||||||Wilcoxon rank-sum test|||||||0.7509
72598008|NCT02651688|144727475|SUPERIORITY|||||||0.5095|||||||Wilcoxon rank-sum test|||||||0.5095
72598009|NCT02651688|144727475|SUPERIORITY|||||||0.623|||||||Wilcoxon rank-sum test|||||||0.6230
72598010|NCT02651688|144727476|SUPERIORITY|||||||0.296|||||||Wilcoxon rank-sum test|||||||0.2960
72598011|NCT02651688|144727476|SUPERIORITY|||||||0.2723|||||||Wilcoxon rank-sum test|||||||0.2723
72598012|NCT02651688|144727477|SUPERIORITY|||||||0.0034|||||||Wilcoxon rank-sum test|||||||0.0034
72598013|NCT02651688|144727477|SUPERIORITY|||||||0.0027|||||||Wilcoxon rank-sum test|||||||0.0027
72598014|NCT02651688|144727478|SUPERIORITY|||||||0.0146|||||||Wilcoxon rank-sum test|||||||0.0146
72598015|NCT02651688|144727478|SUPERIORITY|||||||0.0018|||||||Wilcoxon rank-sum test|||||||0.0018
72598016|NCT02651688|144727479|SUPERIORITY|||||||0.1524|||||||Wilcoxon rank-sum test|||||||0.1524
72598017|NCT02651688|144727479|SUPERIORITY|||||||0.0227|||||||Wilcoxon rank-sum test|||||||0.0227
72598018|NCT02651688|144727480|SUPERIORITY|||||||0.5873|||||||Wilcoxon rank-sum test|||||||0.5873
72598019|NCT02651688|144727480|SUPERIORITY|||||||0.9509|||||||Wilcoxon rank-sum test|||||||0.9509
72598020|NCT02651688|144727481|SUPERIORITY|||||||0.4341|||||||Wilcoxon rank-sum test|||||||0.4341
72598021|NCT02651688|144727481|SUPERIORITY|||||||1|||||||Wilcoxon rank-sum test|||||||1.0000
72598022|NCT02651688|144727482|SUPERIORITY|||||||0.022|||||||Wilcoxon rank-sum test|||||||0.0220
72598023|NCT02651688|144727482|SUPERIORITY|||||||0.3677|||||||Wilcoxon rank-sum test|||||||0.3677
72598024|NCT02651688|144727483|SUPERIORITY|||||||0.9074|||||||Wilcoxon rank-sum test|||||||0.9074
72598025|NCT02651688|144727483|SUPERIORITY|||||||0.4517|||||||Wilcoxon rank-sum test|||||||0.4517
72598026|NCT02651688|144727484|SUPERIORITY|||||||0.2962|||||||Wilcoxon rank-sum test|||||||0.2962
72598027|NCT02651688|144727484|SUPERIORITY|||||||0.3261|||||||Wilcoxon rank-sum test|||||||0.3261
72598028|NCT02651688|144727485|SUPERIORITY|||||||0.045|||||||Wilcoxon rank-sum test|||||||0.0450
72598029|NCT02651688|144727485|SUPERIORITY|||||||0.2235|||||||Wilcoxon rank-sum test|||||||0.2235
72598030|NCT02651688|144727486|SUPERIORITY|||||||0.826|||||||Wilcoxon rank-sum test|||||||0.8260
72598031|NCT02651688|144727486|SUPERIORITY|||||||0.4183|||||||Wilcoxon rank-sum test|||||||0.4183
72598032|NCT02651688|144727487|SUPERIORITY|||||||0.1144|||||||Wilcoxon rank-sum test|||||||0.1144
72598033|NCT02651688|144727487|SUPERIORITY|||||||0.3263|||||||Wilcoxon rank-sum test|||||||0.3263
72598034|NCT02651688|144727488|SUPERIORITY|||||||0.1546|||||||Wilcoxon rank-sum test|||||||0.1546
72598035|NCT02651688|144727488|SUPERIORITY|||||||0.5732|||||||Wilcoxon rank-sum test|||||||0.5732
72598036|NCT02651688|144727489|SUPERIORITY|||||||0.5581|||||||Wilcoxon rank-sum test|||||||0.5581
72598037|NCT02651688|144727489|SUPERIORITY|||||||0.5833|||||||Wilcoxon rank-sum test|||||||0.5833
72598038|NCT02651688|144727490|SUPERIORITY|||||||0.0168|||||||Wilcoxon rank-sum test|||||||0.0168
72598039|NCT02651688|144727490|SUPERIORITY|||||||0.0364|||||||Wilcoxon rank-sum test|||||||0.0364
72598040|NCT02651688|144727491|SUPERIORITY|||||||0.0992|||||||Wilcoxon rank-sum test|||||||0.0992
72598041|NCT02651688|144727491|SUPERIORITY|||||||0.1333|||||||Wilcoxon rank-sum|||||||0.1333
72598042|NCT02651688|144727492|SUPERIORITY|||||||0.0139|||||||Wilcoxon rank-sum test|||||||0.0139
72415773|NCT00833638|144342422|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for day \<=12. No adjustment for multiplicity.|Regression, Logistic|Response = Treatment + Pooled Site + Severity of ED at Baseline.||"Tested was the null-hypothesis that no differences in the precentage of successful intercourse attempts exists between participants who received placebo and participants who received tadalafil 5 mg, measured by a response of yes to the sexual encounter profile diary question number 3."||||<0.001
72415774|NCT00833638|144342422|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for day \<=11. No adjustment for multiplicity.|Regression, Logistic|Response = Treatment + Pooled Site + Severity of ED at Baseline.||"Tested was the null-hypothesis that no differences in the precentage of successful intercourse attempts exists between participants who received placebo and participants who received tadalafil 2.5 mg, measured by a response of yes to the sexual encounter profile diary question number 3."||||<0.001
72415775|NCT00833638|144342422|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for day \<=10. No adjustment for multiplicity.|Regression, Logistic|Response = Treatment + Pooled Site + Severity of ED at Baseline.||"Tested was the null-hypothesis that no differences in the precentage of successful intercourse attempts exists between participants who received placebo and participants who received tadalafil 2.5 mg, measured by a response of yes to the sexual encounter profile diary question number 3."||||<0.001
72598043|NCT02651688|144727492|SUPERIORITY|||||||0.0225|||||||Wilcoxon rank-sum test|||||||0.0225
72598044|NCT00048165|144727493|SUPERIORITY_OR_OTHER||percent mean difference|-12.0||||0.007|TWO_SIDED|95.0|-20.9|-3.3|||Cochran-Mantel-Haenszel|||||-3.3|-20.9|0.007
72598045|NCT00048165|144727494|SUPERIORITY_OR_OTHER||percent mean difference|-8.6||||0.063|TWO_SIDED|95.0|-17.7|0.5|||Cochran-Mantel-Haenszel|||||0.5|-17.7|0.063
72598046|NCT00048165|144727497|SUPERIORITY_OR_OTHER|||||||0.0005|||||||Cochran-Mantel-Haenszel|||Comparison of Daclizumab and Placebo for 6 months were presented||||0.0005
72598047|NCT00048165|144727497|SUPERIORITY_OR_OTHER|||||||0.0008|||||||Cochran-Mantel-Haenszel|||Comparison of Daclizumab and Placebo for 12 months were presented||||0.0008
72598048|NCT00073008|144727527|SUPERIORITY_OR_OTHER||Kaplan-Meier estimate|34.5||||||95.0|13.7|55.4|||||Percentage of surviving participants who were progression free 4 months after the date of randomization|||55.4|13.7|
72598049|NCT00073008|144727527|SUPERIORITY_OR_OTHER||Kaplan-Meier estimate|19.7||||||95.0|2.9|36.4|||||Percentage of surviving participants who were progression free 4 months after the date of randomization|||36.4|2.9|
72598050|NCT00073008|144727528|SUPERIORITY_OR_OTHER||Kaplan-Meier estimate|27.1||||||95.0|11.9|42.3|||||Percentage of surviving participants who were progression free 4 months after the date of randomization|||42.3|11.9|
72598051|NCT00073008|144727528|SUPERIORITY_OR_OTHER||Kaplan-Meier estimate|18.3||||||95.0|3.9|32.6|||||Percentage of surviving participants who were progression free 4 months after the date of randomization|||32.6|3.9|
72598052|NCT02227368|144727602|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1||||0.3441|TWO_SIDED|95.0|-0.4|0.1|||t-test, 2 sided||Difference is Ticagrelor - Aspirin. LOCF was used for missing data imputation.|||0.1|-0.4|0.3441
72598053|NCT02227368|144727603|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.1||||0.6186|TWO_SIDED|95.0|-0.4|0.6|||t-test, 2 sided||Difference is Ticagrelor - Aspirin. LOCF was used for missing data imputation.|||0.6|-0.4|0.6186
72598054|NCT01160380|144727608|SUPERIORITY_OR_OTHER|||||||0.289|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Comparison between arms at Day 28 of treatment||||0.289
72598055|NCT01160380|144727608|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Comparison between Day 1 and Day 28||||<0.001
72598056|NCT01160380|144727608|SUPERIORITY_OR_OTHER||||||<|0.002|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Comparison between Day 1 and day 28||||<0.002
72598057|NCT01160380|144727608|SUPERIORITY_OR_OTHER|||||||0.449|TWO_SIDED||||||t-test, 2 sided|||Comparison between Day 28 and Day 56 of treatment for the armodafinil arm||||0.449
72598058|NCT01160380|144727609|SUPERIORITY_OR_OTHER|||||||0.954|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Comparison between arms at Day 28 of treatment||||0.954
72598059|NCT01160380|144727609|SUPERIORITY_OR_OTHER|||||||0.007|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Day 1 vs. Day 28 of treatment for the Placebo-First arm||||0.007
72598060|NCT01160380|144727609|SUPERIORITY_OR_OTHER|||||||0.369|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Day 1 vs. Day 28 of treatment for the Armodafinil arm||||0.369
72598061|NCT01160380|144727609|SUPERIORITY_OR_OTHER|||||||0.973|TWO_SIDED||||||t-test, 2 sided|||Comparison between Day 28 and Day 56 of treatment for the Armodafinil arm||||0.973
72598062|NCT01160380|144727610|SUPERIORITY_OR_OTHER|||||||0.699|TWO_SIDED||||||t-test, 2 sided|||Comparison between arms at day 28||||0.699
72598063|NCT01160380|144727610|SUPERIORITY_OR_OTHER|||||||0.984|TWO_SIDED||||||t-test, 2 sided|||Day 1 vs. Day 28 of treatment for the Placebo-First arm||||0.984
72598064|NCT01160380|144727610|SUPERIORITY_OR_OTHER|||||||0.239|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Day 1 vs. Day 28 of treatment for the Armodafinil arm||||0.239
72598065|NCT01160380|144727610|SUPERIORITY_OR_OTHER|||||||0.089|TWO_SIDED||||||t-test, 2 sided|||Day 28 vs. Day 56 of treatment for the Armodafinil arm||||0.089
72598066|NCT01160380|144727611|SUPERIORITY_OR_OTHER|||||||0.636|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Comparison between arms at Day 28 of treatment for the Digit Span Test score-Forward test||||0.636
72598067|NCT01160380|144727611|SUPERIORITY_OR_OTHER|||||||0.531|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Comparison between arms at Day 28 of treatment for the Digit Span Test score-Backward test||||0.531
72598068|NCT01160380|144727611|SUPERIORITY_OR_OTHER|||||||0.037|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Day 1 vs. Day 28 of treatment for the Placebo-First arm-Digit Span Test score Forward test||||0.037
72598069|NCT01160380|144727611|SUPERIORITY_OR_OTHER|||||||0.656|TWO_SIDED||||||t-test, 2 sided|||Day 1 vs. Day 28 of treatment for the Placebo-First arm-Digit Span Test score Backward test||||0.656
72598070|NCT01160380|144727611|SUPERIORITY_OR_OTHER|||||||0.028|TWO_SIDED||||||t-test, 2 sided|||Day 1 vs. day 28 of treatment for the Armodafinil arm-Digit Span Test score-Forward test||||0.028
72415776|NCT00833638|144342422|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for day \<=9. No adjustment for multiplicity.|Regression, Logistic|Response = Treatment + Pooled Site + Severity of ED at Baseline.||"Tested was the null-hypothesis that no differences in the precentage of successful intercourse attempts exists between participants who received placebo and participants who received tadalafil 5 mg, measured by a response of yes to the sexual encounter profile diary question number 3."||||<0.001
72415777|NCT00833638|144342422|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for day \<=8. No adjustment for multiplicity.|Regression, Logistic|Response = Treatment + Pooled Site + Severity of ED at Baseline.||"Tested was the null-hypothesis that no differences in the precentage of successful intercourse attempts exists between participants who received placebo and participants who received tadalafil 5 mg, measured by a response of yes to the sexual encounter profile diary question number 3."||||<0.001
72415778|NCT00833638|144342422|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for day \<=7. No adjustment for multiplicity.|Regression, Logistic|Response = Treatment + Pooled Site + Severity of ED at Baseline.||"Tested was the null-hypothesis that no differences in the precentage of successful intercourse attempts exists between participants who received placebo and participants who received tadalafil 5 mg, measured by a response of yes to the sexual encounter profile diary question number 3."||||<0.001
72598071|NCT01160380|144727611|SUPERIORITY_OR_OTHER|||||||0.805|TWO_SIDED||||||t-test, 2 sided|||Day 1 vs. day 28 of treatment for the Armodafinil arm-Digit Span Test score-Backward test||||0.805
72598072|NCT01160380|144727611|SUPERIORITY_OR_OTHER|||||||0.692|TWO_SIDED||||||t-test, 2 sided|||Day 28 vs. day 56 of treatment for the Armodafinil arm-Digit Span Test score-Forward test||||0.692
72598073|NCT01160380|144727611|SUPERIORITY_OR_OTHER|||||||0.863|TWO_SIDED||||||t-test, 2 sided|||Day 28 vs. day 56 of treatment for the Armodafinil arm-Digit Span Test score-Backward test||||0.863
72598074|NCT01160380|144727612|SUPERIORITY_OR_OTHER|||||||0.559|TWO_SIDED||||||t-test, 2 sided|||Comparison between arms for Day 28 of treatment- FACIT-F total||||0.559
72598075|NCT01160380|144727612|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||t-test, 2 sided|||Day 1 vs. Day 28 of treatment for the Placebo-First arm- FACIT-F total||||<0.001
72598076|NCT01160380|144727612|SUPERIORITY_OR_OTHER|||||||0.192|TWO_SIDED||||||t-test, 2 sided|||Day 1 vs. Day 28 of treatment for the Armodafinil arm- FACIT-F total||||0.192
72598077|NCT01160380|144727612|SUPERIORITY_OR_OTHER|||||||0.495|TWO_SIDED||||||t-test, 2 sided|||Day 28 vs. Day 56of treatment for the Armodafinil arm- FACIT-F total||||0.495
72598078|NCT01160380|144727613|SUPERIORITY_OR_OTHER|||||||0.945|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Comparison between arms at Day 28 of treatment- HADS anxiety||||0.945
72598079|NCT01160380|144727613|SUPERIORITY_OR_OTHER|||||||0.316|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Comparison between arms at Day 28 of treatment- HADS depression||||0.316
72598080|NCT01160380|144727613|SUPERIORITY_OR_OTHER|||||||0.005|TWO_SIDED||||||t-test, 2 sided|||Day 1 vs. Day 28 of treatment for the Placebo-First arm-HADS anxiety||||0.005
72598081|NCT01160380|144727613|SUPERIORITY_OR_OTHER|||||||0.005|TWO_SIDED||||||t-test, 2 sided|||Day 1 vs. Day 28 of treatment for the Placebo-First arm-HADS depression||||0.005
72598082|NCT01160380|144727613|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Day 1 vs. Day 28 of treatment for the Armodafinil arm-HADS anxiety||||0.001
72598083|NCT01160380|144727613|SUPERIORITY_OR_OTHER|||||||0.315|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Day 1 vs. Day 28 of treatment for the Placebo-First arm-HADS depression||||0.315
72598084|NCT01160380|144727613|SUPERIORITY_OR_OTHER|||||||0.933|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Day 28 vs. Day 56 of treatment for the Armodafinil arm-HADS anxiety||||0.933
72598085|NCT01160380|144727613|SUPERIORITY_OR_OTHER|||||||0.378|TWO_SIDED||||||t-test, 2 sided|||Day 28 vs. Day 56 of treatment for the Armodafinil arm-HADS depression||||0.378
72598086|NCT01160380|144727614|SUPERIORITY_OR_OTHER|||||||0.84|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Comparison between arms for Day 28 of treatment -ESS||||0.840
72598087|NCT01160380|144727614|SUPERIORITY_OR_OTHER|||||||0.05|TWO_SIDED||||||t-test, 2 sided|||Day 1 vs. Day 28 of treatment for the Placebo-First arm-ESS||||0.050
72598088|NCT01160380|144727614|SUPERIORITY_OR_OTHER|||||||0.051|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Day 1 and Day 28 of treatment for the Armodafinil arm- ESS||||0.051
72598089|NCT01160380|144727614|SUPERIORITY_OR_OTHER|||||||0.635|TWO_SIDED||||||t-test, 2 sided|||Day 28 vs. Day 56 of treatment for the Armodafinil arm||||0.635
72598090|NCT03046056|144727632|SUPERIORITY||Risk Difference in Proportions|8.3|||||TWO_SIDED|90.0|-16.5|32.1||||||||32.1|-16.5|
72598091|NCT03046056|144727632|SUPERIORITY||Risk Difference in Proportions|8.3|||||TWO_SIDED|90.0|-15.9|32.0||||||||32.0|-15.9|
72598092|NCT03046056|144727633|SUPERIORITY||Least Squares Mean Difference|-2.3|STANDARD_ERROR_OF_MEAN|1.81|||TWO_SIDED|90.0|-5.3|0.7||||||Difference in least squared means (Diff in LSM), and its 90% confidence interval (CI) were from analysis of covariance (ANCOVA) model adjusted by baseline segmental MaRIA score, concomitant use of oral, systemically absorbed corticosteroids at baseline, concomitant use of immunomodulators at baseline, prior exposure to biologics, and treatment group.||0.7|-5.3|
72598093|NCT03046056|144727633|SUPERIORITY||Least Squares Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|1.72|||TWO_SIDED|90.0|-2.7|3.1||||||Diff in LSM, and its 90% CI were from ANCOVA model adjusted by baseline segmental MaRIA score, concomitant use of oral, systemically absorbed corticosteroids at baseline, concomitant use of immunomodulators at baseline, prior exposure to biologics, and treatment group.||3.1|-2.7|
72598094|NCT03046056|144727634|SUPERIORITY||Least Squares Mean Difference|-1.6|STANDARD_ERROR_OF_MEAN|1.38|||TWO_SIDED|90.0|-3.9|0.7||||||Diff in LSM, and its 90% CI were from ANCOVA model adjusted by baseline segmental MaRIA score, concomitant use of oral, systemically absorbed corticosteroids at baseline, concomitant use of immunomodulators at baseline, prior exposure to biologics, and treatment group.||0.7|-3.9|
72598095|NCT03046056|144727634|SUPERIORITY||Least Squares Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|1.32|||TWO_SIDED|90.0|-3.2|1.2||||||Diff in LSM, and its 90% CI were from ANCOVA model adjusted by baseline segmental MaRIA score, concomitant use of oral, systemically absorbed corticosteroids at baseline, concomitant use of immunomodulators at baseline, prior exposure to biologics, and treatment group.||1.2|-3.2|
72598096|NCT03046056|144727635|SUPERIORITY||Least Squares Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|1.24|||TWO_SIDED|90.0|-2.2|2.0||||||Diff in LSM, and its 90% CI were from ANCOVA model adjusted by baseline segmental MaRIA score, concomitant use of oral, systemically absorbed corticosteroids at baseline, concomitant use of immunomodulators at baseline, prior exposure to biologics, and treatment group.||2.0|-2.2|
72415779|NCT00833638|144342422|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for day \<=6. No adjustment for multiplicity.|Regression, Logistic|Response = Treatment + Pooled Site + Severity of ED at Baseline.||"Tested was the null-hypothesis that no differences in the precentage of successful intercourse attempts exists between participants who received placebo and participants who received tadalafil 5 mg, measured by a response of yes to the sexual encounter profile diary question number 3."||||<0.001
72598097|NCT03046056|144727635|SUPERIORITY||Least Squares Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|1.18|||TWO_SIDED|90.0|-1.9|2.0||||||Diff in LSM, and its 90% CI were from ANCOVA model adjusted by baseline segmental MaRIA score, concomitant use of oral, systemically absorbed corticosteroids at baseline, concomitant use of immunomodulators at baseline, prior exposure to biologics, and treatment group.||2.0|-1.9|
72598098|NCT03046056|144727636|SUPERIORITY||Risk Difference in Proportions|-1.7|||||TWO_SIDED|90.0|-28.6|25.5||||||||25.5|-28.6|
72598099|NCT03046056|144727636|SUPERIORITY||Risk Difference in Proportions|0.4|||||TWO_SIDED|90.0|-24.5|26.2||||||||26.2|-24.5|
72598100|NCT03046056|144727637|SUPERIORITY||Risk Difference in Proportions|-6.7|||||TWO_SIDED|90.0|-47.3|37.0||||||||37.0|-47.3|
72598101|NCT03046056|144727637|SUPERIORITY||Risk Difference in Proportions|-16.7|||||TWO_SIDED|90.0|-58.2|30.0||||||||30.0|-58.2|
72598102|NCT03046056|144727638|SUPERIORITY||Risk Difference in Proportions|33.3|||||TWO_SIDED|90.0|-32.4|86.5||||||||86.5|-32.4|
72598103|NCT03046056|144727639|SUPERIORITY||Risk Difference in Proportions|-2.3|||||TWO_SIDED|90.0|-28.6|24.3||||||||24.3|-28.6|
72598104|NCT03046056|144727639|SUPERIORITY||Risk Difference in Proportions|-15.0|||||TWO_SIDED|90.0|-39.4|11.3||||||||11.3|-39.4|
72598105|NCT03046056|144727640|SUPERIORITY||Risk Difference in Proportions|3.3|||||TWO_SIDED|90.0|-38.9|45.7||||||||45.7|-38.9|
72598106|NCT03046056|144727640|SUPERIORITY||Risk Difference in Proportions|-4.2|||||TWO_SIDED|90.0|-47.5|40.8||||||||40.8|-47.5|
72598107|NCT03046056|144727641|SUPERIORITY||Risk Difference in Proportions|50.0|||||TWO_SIDED|90.0|-16.8|89.5||||||||89.5|-16.8|
72598108|NCT03046056|144727641|SUPERIORITY||Risk Difference in Proportions|12.5|||||TWO_SIDED|90.0|-46.1|63.3||||||||63.3|-46.1|
72598109|NCT03046056|144727642|SUPERIORITY||Risk Difference in Proportions|8.0|||||TWO_SIDED|90.0|-17.2|32.6||||||||32.6|-17.2|
72598110|NCT03046056|144727642|SUPERIORITY||Risk Difference in Proportions|6.3|||||TWO_SIDED|90.0|-18.1|30.2||||||||30.2|-18.1|
72598111|NCT03046056|144727643|SUPERIORITY||Risk Difference in Proportions|3.3|||||TWO_SIDED|90.0|-22.1|28.1||||||||28.1|-22.1|
72598112|NCT03046056|144727643|SUPERIORITY||Risk Difference in Proportions|-4.2|||||TWO_SIDED|90.0|-28.1|20.3||||||||20.3|-28.1|
72598113|NCT03046056|144727644|SUPERIORITY||Risk Difference in Proportions|17.1|||||TWO_SIDED|90.0|-7.6|40.4||||||||40.4|-7.6|
72598114|NCT03046056|144727644|SUPERIORITY||Risk Difference in Proportions|2.8|||||TWO_SIDED|90.0|-21.2|26.5||||||||26.5|-21.2|
72598115|NCT03046056|144727645|SUPERIORITY||Least Squares Mean Difference|-48.0|STANDARD_ERROR_OF_MEAN|28.1|||TWO_SIDED|90.0|-95.0|-1.0||||||Diff in LSM, and its 90% CI were from ANCOVA model adjusted by baseline segmental MaRIA score, concomitant use of oral, systemically absorbed corticosteroids at baseline, concomitant use of immunomodulators at baseline, prior exposure to biologics, and treatment group.||-1|-95|
72598116|NCT03046056|144727645|SUPERIORITY||Least Squares Mean Difference|-31.0|STANDARD_ERROR_OF_MEAN|27.4|||TWO_SIDED|90.0|-76.0|15.0||||||Diff in LSM, and its 90% CI were from ANCOVA model adjusted by baseline segmental MaRIA score, concomitant use of oral, systemically absorbed corticosteroids at baseline, concomitant use of immunomodulators at baseline, prior exposure to biologics, and treatment group.||15|-76|
72598117|NCT03046056|144727646|SUPERIORITY||Least Squares Mean Difference|-20.0|STANDARD_ERROR_OF_MEAN|28.7|||TWO_SIDED|90.0|-68.0|28.0||||||Diff in LSM, and its 90% CI were from ANCOVA model adjusted by baseline segmental MaRIA score, concomitant use of oral, systemically absorbed corticosteroids at baseline, concomitant use of immunomodulators at baseline, prior exposure to biologics, and treatment group.||28|-68|
72598118|NCT03046056|144727646|SUPERIORITY||Least Squares Mean Difference|-5.0|STANDARD_ERROR_OF_MEAN|28.0|||TWO_SIDED|90.0|-52.0|42.0||||||Diff in LSM, and its 90% CI were from ANCOVA model adjusted by baseline segmental MaRIA score, concomitant use of oral, systemically absorbed corticosteroids at baseline, concomitant use of immunomodulators at baseline, prior exposure to biologics, and treatment group.||42|-52|
72598119|NCT02913105|144727648|OTHER|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (Body Mass Index (BMI) group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.97||||0.7489|TWO_SIDED|90.0|0.83|1.13|||ANCOVA|An unstructured variance-covariance structure was used.||||1.13|0.83|0.7489
72598120|NCT02913105|144727648|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.72||||0.0005|TWO_SIDED|90.0|0.62|0.84|||ANCOVA|An unstructured variance-covariance structure was used.||||0.84|0.62|0.0005
72598121|NCT02913105|144727648|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.74||||0.0005|TWO_SIDED|90.0|0.65|0.85|||ANCOVA|An unstructured variance-covariance structure was used.||||0.85|0.65|0.0005
72598122|NCT02913105|144727653|OTHER|Log transformed ratio to baseline was analyzed using an ANCOVA model which included effects for treatment, log-transformed baseline and stratification factor (BMI group). BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian =30 and Non-Asian=35).|Geometric Mean Ratios|0.95||||0.5354|TWO_SIDED|90.0|0.83|1.09|||ANCOVA|||||1.09|0.83|0.5354
72415780|NCT00833638|144342422|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for day \<=5. No adjustment for multiplicity.|Regression, Logistic|Response = Treatment + Pooled Site + Severity of ED at Baseline.||"Tested was the null-hypothesis that no differences in the precentage of successful intercourse attempts exists between participants who received placebo and participants who received tadalafil 5 mg, measured by a response of yes to the sexual encounter profile diary question number 3."||||<0.001
72598123|NCT02913105|144727653|SUPERIORITY|Log transformed ratio to baseline was analyzed using an ANCOVA model which included effects for treatment, log-transformed baseline and stratification factor (BMI group). BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian =30 and Non-Asian=35).|Geometric Mean Ratios|0.68|||<|0.0001|TWO_SIDED|90.0|0.59|0.78|||ANCOVA|||||0.78|0.59|<.0001
72598124|NCT02913105|144727653|SUPERIORITY|Log transformed ratio to baseline was analyzed using an ANCOVA model which included effects for treatment, log-transformed baseline and stratification factor (BMI group). BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian =30 and Non-Asian=35).|Geometric Mean Ratios|0.71|||<|0.0001|TWO_SIDED|90.0|0.63|0.8|||ANCOVA|||||0.80|0.63|<.0001
72598125|NCT02913105|144727654|OTHER|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Mean Difference (Final Values)|-0.079|STANDARD_ERROR_OF_MEAN|0.389||0.8402|TWO_SIDED|90.0|-0.724|0.567|||ANCOVA|An unstructured variance-covariance structure was used.||Day 28||0.567|-0.724|0.8402
72598126|NCT02913105|144727654|OTHER|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Mean Difference (Final Values)|-0.144|STANDARD_ERROR_OF_MEAN|0.472||0.7607|TWO_SIDED|90.0|-0.927|0.639|||ANCOVA|An unstructured variance-covariance structure was used.||Day 42||0.639|-0.927|0.7607
72598127|NCT02913105|144727654|OTHER|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Mean Difference (Final Values)|-0.228|STANDARD_ERROR_OF_MEAN|0.487||0.6406|TWO_SIDED|90.0|-1.037|0.581|||ANCOVA|An unstructured variance-covariance structure was used.||Day 56||0.581|-1.037|0.6406
72598128|NCT02913105|144727654|OTHER|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Mean Difference (Final Values)|-0.158|STANDARD_ERROR_OF_MEAN|0.685||0.8185|TWO_SIDED|90.0|-1.294|0.979|||ANCOVA|An unstructured variance-covariance structure was used.||Day 84||0.979|-1.294|0.8185
72598129|NCT02913105|144727654|OTHER|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Mean Difference (Final Values)|-0.214|STANDARD_ERROR_OF_MEAN|0.766||0.7804|TWO_SIDED|90.0|-1.485|1.057|||ANCOVA|An unstructured variance-covariance structure was used.||Day 112 (EOS)||1.057|-1.485|0.7804
72598130|NCT02913105|144727654|SUPERIORITY|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Mean Difference (Final Values)|-0.598|STANDARD_ERROR_OF_MEAN|0.402||0.1403|TWO_SIDED|90.0|-1.265|0.07|||ANCOVA|An unstructured variance-covariance structure was used.||Day 28||0.070|-1.265|0.1403
72598131|NCT02913105|144727654|SUPERIORITY|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Mean Difference (Final Values)|-0.93|STANDARD_ERROR_OF_MEAN|0.49||0.0603|TWO_SIDED|90.0|-1.743|-0.117|||ANCOVA|An unstructured variance-covariance structure was used.||Day 42||-0.117|-1.743|0.0603
72415781|NCT00833638|144342422|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for day \<=4. No adjustment for multiplicity.|Regression, Logistic|Response = Treatment + Pooled Site + Severity of ED at Baseline.||"Tested was the null-hypothesis that no differences in the precentage of successful intercourse attempts exists between participants who received placebo and participants who received tadalafil 5 mg, measured by a response of yes to the sexual encounter profile diary question number 3."||||<0.001
72598132|NCT02913105|144727654|SUPERIORITY|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Mean Difference (Final Values)|-1.344|STANDARD_ERROR_OF_MEAN|0.505||0.009|TWO_SIDED|90.0|-2.182|-0.506|||ANCOVA|An unstructured variance-covariance structure was used.||Day 56||-0.506|-2.182|0.0090
72598133|NCT02913105|144727654|SUPERIORITY|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Mean Difference (Final Values)|-1.787|STANDARD_ERROR_OF_MEAN|0.71||0.0134|TWO_SIDED|90.0|-2.965|-0.609|||ANCOVA|An unstructured variance-covariance structure was used.||Day 84||-0.609|-2.965|0.0134
72598134|NCT02913105|144727654|SUPERIORITY|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Mean Difference (Final Values)|-2.123|STANDARD_ERROR_OF_MEAN|0.793||0.0087|TWO_SIDED|90.0|-3.439|-0.807|||ANCOVA|An unstructured variance-covariance structure was used.||Day 112 (EOS)||-0.807|-3.439|0.0087
72598135|NCT02913105|144727654|SUPERIORITY|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Mean Difference (Final Values)|-0.519|STANDARD_ERROR_OF_MEAN|0.368||0.1609|TWO_SIDED|90.0|-1.13|0.091|||ANCOVA|An unstructured variance-covariance structure was used.||Day 28||0.091|-1.130|0.1609
72598136|NCT02913105|144727654|SUPERIORITY|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Mean Difference (Final Values)|-0.786|STANDARD_ERROR_OF_MEAN|0.444||0.0797|TWO_SIDED|90.0|-1.524|-0.049|||ANCOVA|An unstructured variance-covariance structure was used.||Day 42||-0.049|-1.524|0.0797
72598137|NCT02913105|144727654|SUPERIORITY|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Mean Difference (Final Values)|-1.116|STANDARD_ERROR_OF_MEAN|0.455||0.0159|TWO_SIDED|90.0|-1.872|-0.36|||ANCOVA|An unstructured variance-covariance structure was used.||Day 56||-0.360|-1.872|0.0159
72598138|NCT02913105|144727654|SUPERIORITY|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Mean Difference (Final Values)|-1.63|STANDARD_ERROR_OF_MEAN|0.635||0.0118|TWO_SIDED|90.0|-2.684|-0.575|||ANCOVA|An unstructured variance-covariance structure was used.||Day 84||-0.575|-2.684|0.0118
72598139|NCT02913105|144727654|SUPERIORITY|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Mean Difference (Final Values)|-1.909|STANDARD_ERROR_OF_MEAN|0.7||0.0076|TWO_SIDED|90.0|-3.072|-0.746|||ANCOVA|An unstructured variance-covariance structure was used.||Day 112 (EOS)||-0.746|-3.072|0.0076
72598140|NCT02913105|144727655|OTHER|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Mean Difference (Final Values)|-0.033|STANDARD_ERROR_OF_MEAN|0.137||0.8127|TWO_SIDED|90.0|-0.26|0.195|||ANCOVA|An unstructured variance-covariance structure was used.||Day 28||0.195|-0.260|0.8127
72598141|NCT02913105|144727655|OTHER|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Mean Difference (Final Values)|-0.023|STANDARD_ERROR_OF_MEAN|0.166||0.8901|TWO_SIDED|90.0|-0.298|0.252|||ANCOVA|An unstructured variance-covariance structure was used.||Day 42||0.252|-0.298|0.8901
72598142|NCT02913105|144727655|OTHER|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Mean Difference (Final Values)|-0.088|STANDARD_ERROR_OF_MEAN|0.177||0.6209|TWO_SIDED|90.0|-0.381|0.205|||ANCOVA|An unstructured variance-covariance structure was used.||Day 56||0.205|-0.381|0.6209
72598143|NCT02913105|144727655|OTHER|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Mean Difference (Final Values)|-0.048|STANDARD_ERROR_OF_MEAN|0.238||0.8398|TWO_SIDED|90.0|-0.444|0.347|||ANCOVA|An unstructured variance-covariance structure was used.||Day 84||0.347|-0.444|0.8398
72598144|NCT02913105|144727655|OTHER|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Mean Difference (Final Values)|-0.073|STANDARD_ERROR_OF_MEAN|0.266||0.7839|TWO_SIDED|90.0|-0.515|0.369|||ANCOVA|An unstructured variance-covariance structure was used.||Day 112 (EOS)||0.369|-0.515|0.7839
72598145|NCT02913105|144727655|SUPERIORITY|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Mean Difference (Final Values)|-0.241|STANDARD_ERROR_OF_MEAN|0.141||0.0911|TWO_SIDED|90.0|-0.476|-0.006|||ANCOVA|An unstructured variance-covariance structure was used.||Day 28||-0.006|-0.476|0.0911
72598146|NCT02913105|144727655|SUPERIORITY|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Mean Difference (Final Values)|-0.338|STANDARD_ERROR_OF_MEAN|0.172||0.052|TWO_SIDED|90.0|-0.623|-0.053|||ANCOVA|An unstructured variance-covariance structure was used.||Day 42||-0.053|-0.623|0.0520
72598147|NCT02913105|144727655|SUPERIORITY|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Mean Difference (Final Values)|-0.49|STANDARD_ERROR_OF_MEAN|0.183||0.0085|TWO_SIDED|90.0|-0.793|-0.187|||ANCOVA|An unstructured variance-covariance structure was used.||Day 56||-0.187|-0.793|0.0085
72598148|NCT02913105|144727655|SUPERIORITY|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Mean Difference (Final Values)|-0.657|STANDARD_ERROR_OF_MEAN|0.247||0.0091|TWO_SIDED|90.0|-1.067|-0.247|||ANCOVA|An unstructured variance-covariance structure was used.||Day 84||-0.247|-1.067|0.0091
72598149|NCT02913105|144727655|SUPERIORITY|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Mean Difference (Final Values)|-0.759|STANDARD_ERROR_OF_MEAN|0.275||0.007|TWO_SIDED|90.0|-1.216|-0.302|||ANCOVA|An unstructured variance-covariance structure was used.||Day 112 (EOS)||-0.302|-1.216|0.0070
72598150|NCT02913105|144727655|SUPERIORITY|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Mean Difference (Final Values)|-0.208|STANDARD_ERROR_OF_MEAN|0.129||0.1092|TWO_SIDED|90.0|-0.423|0.006|||ANCOVA|An unstructured variance-covariance structure was used.||Day 28||0.006|-0.423|0.1092
72598151|NCT02913105|144727655|SUPERIORITY|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Mean Difference (Final Values)|-0.315|STANDARD_ERROR_OF_MEAN|0.156||0.0457|TWO_SIDED|90.0|-0.574|-0.056|||ANCOVA|An unstructured variance-covariance structure was used.||Day 42||-0.056|-0.574|0.0457
72598152|NCT02913105|144727655|SUPERIORITY|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Mean Difference (Final Values)|-0.402|STANDARD_ERROR_OF_MEAN|0.165||0.0162|TWO_SIDED|90.0|-0.676|-0.129|||ANCOVA|An unstructured variance-covariance structure was used.||Day 56||-0.129|-0.676|0.0162
72598153|NCT02913105|144727655|SUPERIORITY|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Mean Difference (Final Values)|-0.608|STANDARD_ERROR_OF_MEAN|0.221||0.007|TWO_SIDED|90.0|-0.975|-0.242|||ANCOVA|An unstructured variance-covariance structure was used.||Day 84||-0.242|-0.975|0.0070
72415782|NCT00833638|144342422|SUPERIORITY_OR_OTHER|||||||0.003||95.0||||P-value for day \<=3. No adjustment for multiplicity.|Regression, Logistic|Response = Treatment + Pooled Site + Severity of ED at Baseline.||"Tested was the null-hypothesis that no differences in the precentage of successful intercourse attempts exists between participants who received placebo and participants who received tadalafil 5 mg, measured by a response of yes to the sexual encounter profile diary question number 3."||||0.003
72415783|NCT00833638|144342422|SUPERIORITY_OR_OTHER|||||||0.008||95.0||||P-value for day \<=2. No adjustment for multiplicity.|Regression, Logistic|Response = Treatment + Pooled Site + Severity of ED at Baseline.||"Tested was the null-hypothesis that no differences in the precentage of successful intercourse attempts exists between participants who received placebo and participants who received tadalafil 5 mg, measured by a response of yes to the sexual encounter profile diary question number 3."||||0.008
72598154|NCT02913105|144727655|SUPERIORITY|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Mean Difference (Final Values)|-0.686|STANDARD_ERROR_OF_MEAN|0.244||0.006|TWO_SIDED|90.0|-1.091|-0.281|||ANCOVA|An unstructured variance-covariance structure was used.||Day 112 (EOS)||-0.281|-1.091|0.0060
72598155|NCT02913105|144727656|OTHER|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.009||0.9927|TWO_SIDED|90.0|-0.015|0.014|||ANCOVA|An unstructured variance-covariance structure was used.||Day 28||0.014|-0.015|0.9927
72598156|NCT02913105|144727656|OTHER|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Mean Difference (Final Values)|0.014|STANDARD_ERROR_OF_MEAN|0.013||0.2794|TWO_SIDED|90.0|-0.007|0.035|||ANCOVA|An unstructured variance-covariance structure was used.||Day 42||0.035|-0.007|0.2794
72415784|NCT00833638|144342422|SUPERIORITY_OR_OTHER|||||||0.246||95.0||||P-value for day \<=1. No adjustment for multiplicity.|Regression, Logistic|Response = Treatment + Pooled Site + Severity of ED at Baseline.||"Tested was the null-hypothesis that no differences in the precentage of successful intercourse attempts exists between participants who received placebo and participants who received tadalafil 5 mg, measured by a response of yes to the sexual encounter profile diary question number 3."||||0.246
72598157|NCT02913105|144727656|OTHER|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Mean Difference (Final Values)|0.001|STANDARD_ERROR_OF_MEAN|0.007||0.9032|TWO_SIDED|90.0|-0.012|0.013|||ANCOVA|An unstructured variance-covariance structure was used.||Day 56||0.013|-0.012|0.9032
72598158|NCT02913105|144727656|OTHER|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Mean Difference (Final Values)|0.009|STANDARD_ERROR_OF_MEAN|0.011||0.4163|TWO_SIDED|90.0|-0.009|0.027|||ANCOVA|An unstructured variance-covariance structure was used.||Day 84||0.027|-0.009|0.4163
72598159|NCT02913105|144727656|OTHER|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Mean Difference (Final Values)|-0.004|STANDARD_ERROR_OF_MEAN|0.011||0.7001|TWO_SIDED|90.0|-0.022|0.014|||ANCOVA|An unstructured variance-covariance structure was used.||Day 112 (EOS)||0.014|-0.022|0.7001
72598160|NCT02913105|144727656|SUPERIORITY|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Mean Difference (Final Values)|0.006|STANDARD_ERROR_OF_MEAN|0.009||0.5367|TWO_SIDED|90.0|-0.009|0.021|||ANCOVA|An unstructured variance-covariance structure was used.||Day 28||0.021|-0.009|0.5367
72598161|NCT02913105|144727656|SUPERIORITY|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Mean Difference (Final Values)|0.008|STANDARD_ERROR_OF_MEAN|0.013||0.5496|TWO_SIDED|90.0|-0.014|0.03|||ANCOVA|An unstructured variance-covariance structure was used.||Day 42||0.030|-0.014|0.5496
72598162|NCT02913105|144727656|SUPERIORITY|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Mean Difference (Final Values)|0.003|STANDARD_ERROR_OF_MEAN|0.008||0.6844|TWO_SIDED|90.0|-0.01|0.016|||ANCOVA|An unstructured variance-covariance structure was used.||Day 56||0.016|-0.010|0.6844
72598163|NCT02913105|144727656|SUPERIORITY|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Mean Difference (Final Values)|-0.007|STANDARD_ERROR_OF_MEAN|0.011||0.5695|TWO_SIDED|90.0|-0.025|0.012|||ANCOVA|An unstructured variance-covariance structure was used.||Day 84||0.012|-0.025|0.5695
72598164|NCT02913105|144727656|SUPERIORITY|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Mean Difference (Final Values)|-0.003|STANDARD_ERROR_OF_MEAN|0.011||0.8015|TWO_SIDED|90.0|-0.021|0.016|||ANCOVA|An unstructured variance-covariance structure was used.||Day 112 (EOS)||0.016|-0.021|0.8015
72598165|NCT02913105|144727656|SUPERIORITY|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Mean Difference (Final Values)|0.006|STANDARD_ERROR_OF_MEAN|0.008||0.4923|TWO_SIDED|90.0|-0.008|0.02|||ANCOVA|An unstructured variance-covariance structure was used.||Day 28||0.020|-0.008|0.4923
72598166|NCT02913105|144727656|SUPERIORITY|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Mean Difference (Final Values)|-0.006|STANDARD_ERROR_OF_MEAN|0.012||0.62|TWO_SIDED|90.0|-0.025|0.014|||ANCOVA|An unstructured variance-covariance structure was used.||Day 42||0.014|-0.025|0.6200
72598167|NCT02913105|144727656|SUPERIORITY|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Mean Difference (Final Values)|0.002|STANDARD_ERROR_OF_MEAN|0.007||0.7423|TWO_SIDED|90.0|-0.009|0.014|||ANCOVA|An unstructured variance-covariance structure was used.||Day 56||0.014|-0.009|0.7423
72598168|NCT02913105|144727656|SUPERIORITY|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Mean Difference (Final Values)|-0.016|STANDARD_ERROR_OF_MEAN|0.01||0.1272|TWO_SIDED|90.0|-0.032|0.001|||ANCOVA|An unstructured variance-covariance structure was used.||Day 84||0.001|-0.032|0.1272
72598169|NCT02913105|144727656|SUPERIORITY|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Mean Difference (Final Values)|0.001|STANDARD_ERROR_OF_MEAN|0.01||0.8883|TWO_SIDED|90.0|-0.015|0.017|||ANCOVA|An unstructured variance-covariance structure was used.||Day 112 (EOS)||0.017|-0.015|0.8883
72598170|NCT02913105|144727657|OTHER|Log transformed ratio to baseline was analyzed using an ANCOVA model which included effects for treatment, log-transformed baseline and stratification factor (BMI group). BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian =30 and Non-Asian=35).|Geometric Mean Ratios|1.01||||0.9514|TWO_SIDED|90.0|0.84|1.21|||ANCOVA|||||1.21|0.84|0.9514
72598171|NCT02913105|144727657|SUPERIORITY|Log transformed ratio to baseline was analyzed using an ANCOVA model which included effects for treatment, log-transformed baseline and stratification factor (BMI group). BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian =30 and Non-Asian=35).|Geometric Mean Ratios|0.93||||0.5168|TWO_SIDED|90.0|0.78|1.12|||ANCOVA|||||1.12|0.78|0.5168
72598172|NCT02913105|144727657|SUPERIORITY|Log transformed ratio to baseline was analyzed using an ANCOVA model which included effects for treatment, log-transformed baseline and stratification factor (BMI group). BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian =30 and Non-Asian=35).|Geometric Mean Ratios|0.93||||0.374|TWO_SIDED|90.0|0.8|1.07|||ANCOVA|||||1.07|0.80|0.3740
72598173|NCT02913105|144727658|OTHER|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|1.0||||0.9453|TWO_SIDED|90.0|0.97|1.02|||ANCOVA|An unstructured variance-covariance structure was used.||Day 42||1.02|0.97|0.9453
72598174|NCT02913105|144727658|OTHER|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.99||||0.4344|TWO_SIDED|90.0|0.96|1.01|||ANCOVA|An unstructured variance-covariance structure was used.||Day 84||1.01|0.96|0.4344
72598175|NCT02913105|144727658|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.99||||0.639|TWO_SIDED|90.0|0.97|1.02|||ANCOVA|An unstructured variance-covariance structure was used.||Day 42||1.02|0.97|0.6390
72598176|NCT02913105|144727658|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.99||||0.6329|TWO_SIDED|90.0|0.97|1.02|||ANCOVA|An unstructured variance-covariance structure was used.||Day 84||1.02|0.97|0.6329
72598177|NCT02913105|144727658|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.99||||0.664|TWO_SIDED|90.0|0.97|1.02|||ANCOVA|An unstructured variance-covariance structure was used.||Day 42||1.02|0.97|0.6640
72598178|NCT02913105|144727658|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|1.0||||0.7517|TWO_SIDED|90.0|0.98|1.03|||ANCOVA|An unstructured variance-covariance structure was used.||Day 84||1.03|0.98|0.7517
72598179|NCT02913105|144727659|OTHER|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.96||||0.739|TWO_SIDED|90.0|0.77|1.19|||ANCOVA|An unstructured variance-covariance structure was used.||HA: Day 42||1.19|0.77|0.7390
72598180|NCT02913105|144727659|OTHER|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.88||||0.3086|TWO_SIDED|90.0|0.72|1.08|||ANCOVA|An unstructured variance-covariance structure was used.||HA: Day 84||1.08|0.72|0.3086
72598181|NCT02913105|144727659|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.86||||0.288|TWO_SIDED|90.0|0.69|1.08|||ANCOVA|An unstructured variance-covariance structure was used.||HA: Day 42||1.08|0.69|0.2880
72598182|NCT02913105|144727659|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.91||||0.4446|TWO_SIDED|90.0|0.73|1.12|||ANCOVA|An unstructured variance-covariance structure was used.||HA: Day 84||1.12|0.73|0.4446
72598183|NCT02913105|144727659|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.9||||0.4127|TWO_SIDED|90.0|0.73|1.11|||ANCOVA|An unstructured variance-covariance structure was used.||HA: Day 42||1.11|0.73|0.4127
72598184|NCT02913105|144727659|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|1.03||||0.8074|TWO_SIDED|90.0|0.85|1.25|||ANCOVA|An unstructured variance-covariance structure was used.||HA: Day 84||1.25|0.85|0.8074
72598185|NCT02913105|144727659|OTHER|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.98||||0.6935|TWO_SIDED|90.0|0.88|1.08|||ANCOVA|An unstructured variance-covariance structure was used.||PIIINP: Day 42||1.08|0.88|0.6935
72598186|NCT02913105|144727659|OTHER|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.99||||0.9145|TWO_SIDED|90.0|0.9|1.09|||ANCOVA|An unstructured variance-covariance structure was used.||PIIINP: Day 84||1.09|0.90|0.9145
72598187|NCT02913105|144727659|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|1.01||||0.9131|TWO_SIDED|90.0|0.91|1.12|||ANCOVA|An unstructured variance-covariance structure was used.||PIIINP: Day 42||1.12|0.91|0.9131
72598188|NCT02913105|144727659|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|1.0||||0.9988|TWO_SIDED|90.0|0.91|1.1|||ANCOVA|An unstructured variance-covariance structure was used.||PIIINP: Day 84||1.10|0.91|0.9988
72598189|NCT02913105|144727659|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|1.03||||0.5873|TWO_SIDED|90.0|0.94|1.13|||ANCOVA|An unstructured variance-covariance structure was used.||PIIINP: Day 42||1.13|0.94|0.5873
72598190|NCT02913105|144727659|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|1.01||||0.905|TWO_SIDED|90.0|0.92|1.1|||ANCOVA|An unstructured variance-covariance structure was used.||PIIINP: Day 84||1.10|0.92|0.9050
72598191|NCT02913105|144727659|OTHER|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|1.05||||0.1458|TWO_SIDED|90.0|0.99|1.11|||ANCOVA|An unstructured variance-covariance structure was used.||TIMP-1: Day 42||1.11|0.99|0.1458
72598192|NCT02913105|144727659|OTHER|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|1.05||||0.2048|TWO_SIDED|90.0|0.98|1.12|||ANCOVA|An unstructured variance-covariance structure was used.||TIMP-1: Day 84||1.12|0.98|0.2048
72415785|NCT00833638|144342423|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-36.05|||<|0.001||95.0|||||t-test, 2 sided||the estimated mean difference shows changes in the double-blind treatment phase minus changes in the open label treatment phase|"Tested was the null-hypothesis that no differences in the proportion of successful intercourse attempts exist in patients who received placebo in the double-blind treatment period when comparing their proportion of succesful intercourse attempts between the double-blind treatment period (while receiving placebo) and the open-label treatment period (while receiving tadalafil 5 mg), measured by a response of yes to the sexual encounter profile diary question number 3."||||<0.001
72598193|NCT02913105|144727659|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|1.06||||0.1051|TWO_SIDED|90.0|1.0|1.12|||ANCOVA|An unstructured variance-covariance structure was used.||TIMP-1: Day 42||1.12|1.00|0.1051
72598194|NCT02913105|144727659|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|1.08||||0.0717|TWO_SIDED|90.0|1.01|1.15|||ANCOVA|An unstructured variance-covariance structure was used.||TIMP-1: Day 84||1.15|1.01|0.0717
72598195|NCT02913105|144727659|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|1.01||||0.8083|TWO_SIDED|90.0|0.96|1.06|||ANCOVA|An unstructured variance-covariance structure was used.||TIMP-1: Day 42||1.06|0.96|0.8083
72598196|NCT02913105|144727659|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|1.02||||0.5361|TWO_SIDED|90.0|0.96|1.09|||ANCOVA|An unstructured variance-covariance structure was used.||TIMP-1: Day 84||1.09|0.96|0.5361
72598197|NCT02913105|144727660|OTHER|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.96||||0.0858|TWO_SIDED|90.0|0.92|1.0|||ANCOVA|An unstructured variance-covariance structure was used.||Cholesterol: Day 7||1.00|0.92|0.0858
72598198|NCT02913105|144727660|OTHER|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.93||||0.0096|TWO_SIDED|90.0|0.88|0.97|||ANCOVA|An unstructured variance-covariance structure was used.||Cholesterol: Day 14||0.97|0.88|0.0096
72598199|NCT02913105|144727660|OTHER|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.93||||0.0284|TWO_SIDED|90.0|0.88|0.98|||ANCOVA|An unstructured variance-covariance structure was used.||Cholesterol: Day 28||0.98|0.88|0.0284
72598200|NCT02913105|144727660|OTHER|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.95||||0.133|TWO_SIDED|90.0|0.89|1.01|||ANCOVA|An unstructured variance-covariance structure was used.||Cholesterol: Day 42||1.01|0.89|0.1330
72598201|NCT02913105|144727660|OTHER|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.95||||0.2032|TWO_SIDED|90.0|0.89|1.01|||ANCOVA|An unstructured variance-covariance structure was used.||Cholesterol: Day 56||1.01|0.89|0.2032
72598202|NCT02913105|144727660|OTHER|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.94||||0.1141|TWO_SIDED|90.0|0.87|1.0|||ANCOVA|An unstructured variance-covariance structure was used.||Cholesterol: Day 84||1.00|0.87|0.1141
72598203|NCT02913105|144727660|OTHER|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.94||||0.1342|TWO_SIDED|90.0|0.88|1.01|||ANCOVA|An unstructured variance-covariance structure was used.||Cholesterol: Day 112 (EOS)||1.01|0.88|0.1342
72415786|NCT00833638|144342424|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-22.22|||<|0.001||95.0|||||t-test, 2 sided||the estimated mean difference shows changes in the double-blind treatment phase minus changes in the open label treatment phase|"Tested was the null-hypothesis that no differences in the proportion of successful intercourse attempts exist in patients who received tadalafil 2.5 mg in the double-blind treatment period when comparing their proportion of succesful intercourse attempts between the double-blind treatment period (while receiving tadalafil 2.5 mg) and the open-label treatment period (while receiving tadalafil 5 mg), measured by a response of yes to the sexual encounter profile diary question number 3."||||<0.001
72598204|NCT02913105|144727660|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.96||||0.0771|TWO_SIDED|90.0|0.92|1.0|||ANCOVA|An unstructured variance-covariance structure was used.||Cholesterol: Day 7||1.00|0.92|0.0771
72598205|NCT02913105|144727660|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.96||||0.151|TWO_SIDED|90.0|0.91|1.01|||ANCOVA|An unstructured variance-covariance structure was used.||Cholesterol: Day 14||1.01|0.91|0.1510
72598206|NCT02913105|144727660|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.94||||0.0744|TWO_SIDED|90.0|0.89|1.0|||ANCOVA|An unstructured variance-covariance structure was used.||Cholesterol: Day 28||1.00|0.89|0.0744
72598207|NCT02913105|144727660|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.99||||0.8365|TWO_SIDED|90.0|0.93|1.06|||ANCOVA|An unstructured variance-covariance structure was used.||Cholesterol: Day 42||1.06|0.93|0.8365
72598208|NCT02913105|144727660|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.98||||0.6091|TWO_SIDED|90.0|0.92|1.05|||ANCOVA|An unstructured variance-covariance structure was used.||Cholesterol: Day 56||1.05|0.92|0.6091
72598209|NCT02913105|144727660|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.96||||0.3621|TWO_SIDED|90.0|0.9|1.03|||ANCOVA|An unstructured variance-covariance structure was used.||Cholesterol: Day 84||1.03|0.90|0.3621
72598210|NCT02913105|144727660|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.97||||0.5031|TWO_SIDED|90.0|0.91|1.04|||ANCOVA|An unstructured variance-covariance structure was used.||Cholesterol: Day 112 (EOS)||1.04|0.91|0.5031
72598211|NCT02913105|144727660|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|1.0||||0.9244|TWO_SIDED|90.0|0.96|1.04|||ANCOVA|An unstructured variance-covariance structure was used.||Cholesterol: Day 7||1.04|0.96|0.9244
72598212|NCT02913105|144727660|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|1.03||||0.236|TWO_SIDED|90.0|0.99|1.08|||ANCOVA|An unstructured variance-covariance structure was used.||Cholesterol: Day 14||1.08|0.99|0.2360
72598213|NCT02913105|144727660|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|1.01||||0.699|TWO_SIDED|90.0|0.96|1.07|||ANCOVA|An unstructured variance-covariance structure was used.||Cholesterol: Day 28||1.07|0.96|0.6990
72598214|NCT02913105|144727660|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|1.05||||0.159|TWO_SIDED|90.0|0.99|1.11|||ANCOVA|An unstructured variance-covariance structure was used.||Cholesterol: Day 42||1.11|0.99|0.1590
72598215|NCT02913105|144727660|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|1.03||||0.4256|TWO_SIDED|90.0|0.97|1.09|||ANCOVA|An unstructured variance-covariance structure was used.||Cholesterol: Day 56||1.09|0.97|0.4256
72598216|NCT02913105|144727660|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|1.03||||0.4901|TWO_SIDED|90.0|0.96|1.09|||ANCOVA|An unstructured variance-covariance structure was used.||Cholesterol: Day 84||1.09|0.96|0.4901
72598217|NCT02913105|144727660|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|1.03||||0.3648|TWO_SIDED|90.0|0.97|1.09|||ANCOVA|An unstructured variance-covariance structure was used.||Cholesterol: Day 112 (EOS)||1.09|0.97|0.3648
72598218|NCT02913105|144727660|OTHER|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|1.01||||0.8891|TWO_SIDED|90.0|0.91|1.12|||ANCOVA|An unstructured variance-covariance structure was used.||Triglycerides: Day 7||1.12|0.91|0.8891
72598219|NCT02913105|144727660|OTHER|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.95||||0.4817|TWO_SIDED|90.0|0.85|1.07|||ANCOVA|An unstructured variance-covariance structure was used.||Triglycerides: Day 14||1.07|0.85|0.4817
72598220|NCT02913105|144727660|OTHER|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.96||||0.6022|TWO_SIDED|90.0|0.84|1.09|||ANCOVA|An unstructured variance-covariance structure was used.||Triglycerides: Day 28||1.09|0.84|0.6022
72598221|NCT02913105|144727660|OTHER|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.94||||0.447|TWO_SIDED|90.0|0.83|1.07|||ANCOVA|An unstructured variance-covariance structure was used.||Triglycerides: Day 42||1.07|0.83|0.4470
72598222|NCT02913105|144727660|OTHER|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.94||||0.4342|TWO_SIDED|90.0|0.83|1.07|||ANCOVA|An unstructured variance-covariance structure was used.||Triglycerides: Day 56||1.07|0.83|0.4342
72598223|NCT02913105|144727660|OTHER|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.85||||0.0891|TWO_SIDED|90.0|0.73|0.99|||ANCOVA|An unstructured variance-covariance structure was used.||Triglycerides: Day 84||0.99|0.73|0.0891
72598224|NCT02913105|144727660|OTHER|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.89||||0.226|TWO_SIDED|90.0|0.77|1.04|||ANCOVA|An unstructured variance-covariance structure was used.||Triglycerides: Day 112 (EOS)||1.04|0.77|0.2260
72598225|NCT02913105|144727660|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.87||||0.0324|TWO_SIDED|90.0|0.78|0.97|||ANCOVA|An unstructured variance-covariance structure was used.||Triglycerides: Day 7||0.97|0.78|0.0324
72598226|NCT02913105|144727660|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.85||||0.0291|TWO_SIDED|90.0|0.76|0.96|||ANCOVA|An unstructured variance-covariance structure was used.||Triglycerides: Day 14||0.96|0.76|0.0291
72598227|NCT02913105|144727660|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.96||||0.5755|TWO_SIDED|90.0|0.84|1.09|||ANCOVA|An unstructured variance-covariance structure was used.||Triglycerides: Day 28||1.09|0.84|0.5755
72598228|NCT02913105|144727660|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.92||||0.307|TWO_SIDED|90.0|0.8|1.05|||ANCOVA|An unstructured variance-covariance structure was used.||Triglycerides: Day 42||1.05|0.80|0.3070
72598229|NCT02913105|144727660|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.98||||0.7752|TWO_SIDED|90.0|0.86|1.12|||ANCOVA|An unstructured variance-covariance structure was used.||Triglycerides: Day 56||1.12|0.86|0.7752
72598230|NCT02913105|144727660|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.88||||0.1803|TWO_SIDED|90.0|0.75|1.03|||ANCOVA|An unstructured variance-covariance structure was used.||Triglycerides: Day 84||1.03|0.75|0.1803
72415787|NCT00833638|144342425|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-18.16|||<|0.001||95.0|||||t-test, 2 sided||the estimated mean difference shows changes in the double-blind treatment phase minus changes in the open label treatment phase|"Tested was the null-hypothesis that no differences in the proportion of successful intercourse attempts exist in patients who received tadalfil 5 mg in the double-blind treatment period when comparing their proportion of succesful intercourse attempts between the double-blind treatment period (while receiving tadalafil 5 mg) and the open-label treatment period (while receiving tadalafil 5 mg), measured by a response of yes to the sexual encounter profile diary question number 3."||||<0.001
72598231|NCT02913105|144727660|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.89||||0.2414|TWO_SIDED|90.0|0.76|1.05|||ANCOVA|An unstructured variance-covariance structure was used.||Triglycerides: Day 112 (EOS)||1.05|0.76|0.2414
72598232|NCT02913105|144727660|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.86||||0.0179|TWO_SIDED|90.0|0.77|0.95|||ANCOVA|An unstructured variance-covariance structure was used.||Triglycerides: Day 7||0.95|0.77|0.0179
72598233|NCT02913105|144727660|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.9||||0.1125|TWO_SIDED|90.0|0.8|1.0|||ANCOVA|An unstructured variance-covariance structure was used.||Triglycerides: Day 14||1.00|0.80|0.1125
72598234|NCT02913105|144727660|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|1.0||||0.9572|TWO_SIDED|90.0|0.88|1.12|||ANCOVA|An unstructured variance-covariance structure was used.||Triglycerides: Day 28||1.12|0.88|0.9572
72598235|NCT02913105|144727660|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.98||||0.7372|TWO_SIDED|90.0|0.87|1.1|||ANCOVA|An unstructured variance-covariance structure was used.||Triglycerides: Day 42||1.10|0.87|0.7372
72598236|NCT02913105|144727660|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|1.04||||0.6015|TWO_SIDED|90.0|0.92|1.17|||ANCOVA|An unstructured variance-covariance structure was used.||Triglycerides: Day 56||1.17|0.92|0.6015
72598237|NCT02913105|144727660|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|1.03||||0.7261|TWO_SIDED|90.0|0.89|1.19|||ANCOVA|An unstructured variance-covariance structure was used.||Triglycerides: Day 84||1.19|0.89|0.7261
72415788|NCT00833638|144342426|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-25.11|||<|0.001||95.0|||||t-test, 2 sided||the estimated mean difference shows changes in the double-blind treatment phase minus changes in the open label treatment phase|"Tested was the null-hypothesis that no differences in the percentages of successful intercourse attempts exist in participants who received tadalafil 2.5 mg in the double-blind treatment period and did not respond to treatment when comparing their percentage of succesful intercourse attempts between the double-blind treatment period and the open-label treatment period (while receiving tadalafil 5 mg), measured by a response of yes to the sexual encounter profile diary question number 3."||||<0.001
72598238|NCT02913105|144727660|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|1.0||||0.9892|TWO_SIDED|90.0|0.87|1.15|||ANCOVA|An unstructured variance-covariance structure was used.||Triglycerides: Day 112 (EOS)||1.15|0.87|0.9892
72598239|NCT02913105|144727661|OTHER|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.91||||0.0005|TWO_SIDED|90.0|0.87|0.95|||ANCOVA|An unstructured variance-covariance structure was used.||HDL Cholesterol: Day 7||0.95|0.87|0.0005
72598240|NCT02913105|144727661|OTHER|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.89||||0.0005|TWO_SIDED|90.0|0.84|0.94|||ANCOVA|An unstructured variance-covariance structure was used.||HDL Cholesterol: Day 14||0.94|0.84|0.0005
72598241|NCT02913105|144727661|OTHER|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.91||||0.0062|TWO_SIDED|90.0|0.86|0.96|||ANCOVA|An unstructured variance-covariance structure was used.||HDL Cholesterol: Day 28||0.96|0.86|0.0062
72598242|NCT02913105|144727661|OTHER|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.94||||0.1214|TWO_SIDED|90.0|0.89|1.0|||ANCOVA|An unstructured variance-covariance structure was used.||HDL Cholesterol: Day 42||1.00|0.89|0.1214
72598243|NCT02913105|144727661|OTHER|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.9||||0.0043|TWO_SIDED|90.0|0.84|0.95|||ANCOVA|An unstructured variance-covariance structure was used.||HDL Cholesterol: Day 56||0.95|0.84|0.0043
72598244|NCT02913105|144727661|OTHER|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.95||||0.2615|TWO_SIDED|90.0|0.89|1.02|||ANCOVA|An unstructured variance-covariance structure was used.||HDL Cholesterol: Day 84||1.02|0.89|0.2615
72598245|NCT02913105|144727661|OTHER|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.94||||0.1331|TWO_SIDED|90.0|0.88|1.01|||ANCOVA|An unstructured variance-covariance structure was used.||HDL Cholesterol: Day 112 (EOS)||1.01|0.88|0.1331
72598246|NCT02913105|144727661|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.85|||<|0.0001|TWO_SIDED|90.0|0.81|0.89|||ANCOVA|An unstructured variance-covariance structure was used.||HDL Cholesterol: Day 7||0.89|0.81|<.0001
72415789|NCT01680328|144342427|SUPERIORITY_OR_OTHER||Least Squares Mean|-0.1||||||95.0|-2.9|2.8||||||Though the sample size was not based on any formal sample size or power calculations as no statistical tests were pre-specified to address the endpoints, a sample size of 80 completers was derived from a simulation study. Mean Difference in injection pain on VAS after injection of different volumes was calculated as least square mean estimate of the mean difference in injection pain.||2.8|-2.9|
72598247|NCT02913105|144727661|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.88||||0.0001|TWO_SIDED|90.0|0.83|0.93|||ANCOVA|An unstructured variance-covariance structure was used.||HDL Cholesterol: Day 14||0.93|0.83|0.0001
72598248|NCT02913105|144727661|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.83|||<|0.0001|TWO_SIDED|90.0|0.79|0.88|||ANCOVA|An unstructured variance-covariance structure was used.||HDL Cholesterol: Day 28||0.88|0.79|<.0001
72598249|NCT02913105|144727661|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.86||||0.0002|TWO_SIDED|90.0|0.81|0.92|||ANCOVA|An unstructured variance-covariance structure was used.||HDL Cholesterol: Day 42||0.92|0.81|0.0002
72598250|NCT02913105|144727661|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.82|||<|0.0001|TWO_SIDED|90.0|0.77|0.88|||ANCOVA|An unstructured variance-covariance structure was used.||HDL Cholesterol: Day 56||0.88|0.77|<.0001
72598251|NCT02913105|144727661|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.84||||0.0002|TWO_SIDED|90.0|0.78|0.9|||ANCOVA|An unstructured variance-covariance structure was used.||HDL Cholesterol: Day 84||0.90|0.78|0.0002
72598252|NCT02913105|144727661|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.95||||0.228|TWO_SIDED|90.0|0.89|1.02|||ANCOVA|An unstructured variance-covariance structure was used.||HDL Cholesterol: Day 112 (EOS)||1.02|0.89|0.2280
72415790|NCT01680328|144342427|SUPERIORITY_OR_OTHER||Least Squares Mean|3.5||||||95.0|0.4|6.6||||||Though the sample size was not based on any formal sample size or power calculations as no statistical tests were pre-specified to address the endpoints, a sample size of 80 completers was derived from a simulation study. Mean Difference in injection pain on VAS after injection of different volumes was calculated as least square mean estimate of the mean difference in injection pain.||6.6|0.4|
72415791|NCT01680328|144342427|SUPERIORITY_OR_OTHER||Least Squares Mean|7.2||||||95.0|4.6|9.7||||||Though the sample size was not based on any formal sample size or power calculations as no statistical tests were pre-specified to address the endpoints, a sample size of 80 completers was derived from a simulation study. Mean Difference in injection pain on VAS after injection of different volumes was calculated as least square mean estimate of the mean difference in injection pain.||9.7|4.6|
72598253|NCT02913105|144727661|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.93||||0.009|TWO_SIDED|90.0|0.89|0.97|||ANCOVA|An unstructured variance-covariance structure was used.||HDL Cholesterol: Day 7||0.97|0.89|0.0090
72415792|NCT01680328|144342427|SUPERIORITY_OR_OTHER||Least Squares Mean|3.6||||||95.0|0.4|6.7||||||Though the sample size was not based on any formal sample size or power calculations as no statistical tests were pre-specified to address the endpoints, a sample size of 80 completers was derived from a simulation study. Mean Difference in injection pain on VAS after injection of different volumes was calculated as least square mean estimate of the mean difference in injection pain.||6.7|0.4|
72415793|NCT01680328|144342427|SUPERIORITY_OR_OTHER||Least Squares Mean|7.2||||||95.0|4.4|10.0||||||Though the sample size was not based on any formal sample size or power calculations as no statistical tests were pre-specified to address the endpoints, a sample size of 80 completers was derived from a simulation study. Mean Difference in injection pain on VAS after injection of different volumes was calculated as least square mean estimate of the mean difference in injection pain.||10.0|4.4|
72598254|NCT02913105|144727661|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.98||||0.6237|TWO_SIDED|90.0|0.93|1.04|||ANCOVA|An unstructured variance-covariance structure was used.||HDL Cholesterol: Day 14||1.04|0.93|0.6237
72598255|NCT02913105|144727661|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.91||||0.008|TWO_SIDED|90.0|0.87|0.97|||ANCOVA|An unstructured variance-covariance structure was used.||HDL Cholesterol: Day 28||0.97|0.87|0.0080
72598256|NCT02913105|144727661|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.91||||0.0105|TWO_SIDED|90.0|0.86|0.97|||ANCOVA|An unstructured variance-covariance structure was used.||HDL Cholesterol: Day 42||0.97|0.86|0.0105
72598257|NCT02913105|144727661|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.92||||0.0217|TWO_SIDED|90.0|0.86|0.98|||ANCOVA|An unstructured variance-covariance structure was used.||HDL Cholesterol: Day 56||0.98|0.86|0.0217
72598258|NCT02913105|144727661|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.88||||0.0031|TWO_SIDED|90.0|0.82|0.94|||ANCOVA|An unstructured variance-covariance structure was used.||HDL Cholesterol: Day 84||0.94|0.82|0.0031
72598259|NCT02913105|144727661|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|1.01||||0.774|TWO_SIDED|90.0|0.95|1.07|||ANCOVA|An unstructured variance-covariance structure was used.||HDL Cholesterol: Day 112 (EOS)||1.07|0.95|0.7740
72598260|NCT02913105|144727661|OTHER|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.95||||0.1783|TWO_SIDED|90.0|0.89|1.01|||ANCOVA|An unstructured variance-covariance structure was used.||LDL Cholesterol Friedwald: Day 7||1.01|0.89|0.1783
72598261|NCT02913105|144727661|OTHER|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.91||||0.0219|TWO_SIDED|90.0|0.84|0.97|||ANCOVA|An unstructured variance-covariance structure was used.||LDL Cholesterol Friedwald: Day 14||0.97|0.84|0.0219
72598262|NCT02913105|144727661|OTHER|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.92||||0.0719|TWO_SIDED|90.0|0.85|0.99|||ANCOVA|An unstructured variance-covariance structure was used.||LDL Cholesterol Friedwald: Day 28||0.99|0.85|0.0719
72598263|NCT02913105|144727661|OTHER|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.93||||0.2199|TWO_SIDED|90.0|0.85|1.02|||ANCOVA|An unstructured variance-covariance structure was used.||LDL Cholesterol Friedwald: Day 42||1.02|0.85|0.2199
72598264|NCT02913105|144727661|OTHER|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.96||||0.4928|TWO_SIDED|90.0|0.87|1.06|||ANCOVA|An unstructured variance-covariance structure was used.||LDL Cholesterol Friedwald: Day 56||1.06|0.87|0.4928
72598265|NCT02913105|144727661|OTHER|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.94||||0.3419|TWO_SIDED|90.0|0.85|1.05|||ANCOVA|An unstructured variance-covariance structure was used.||LDL Cholesterol Friedwald: Day 84||1.05|0.85|0.3419
72598266|NCT02913105|144727661|OTHER|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.98||||0.7281|TWO_SIDED|90.0|0.88|1.09|||ANCOVA|An unstructured variance-covariance structure was used.||LDL Cholesterol Friedwald: Day 112 (EOS)||1.09|0.88|0.7281
72598267|NCT02913105|144727661|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|1.04||||0.318|TWO_SIDED|90.0|0.97|1.12|||ANCOVA|An unstructured variance-covariance structure was used.||LDL Cholesterol Friedwald: Day 7||1.12|0.97|0.3180
72598268|NCT02913105|144727661|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|1.02||||0.6576|TWO_SIDED|90.0|0.95|1.1|||ANCOVA|An unstructured variance-covariance structure was used.||LDL Cholesterol Friedwald: Day 14||1.10|0.95|0.6576
72598269|NCT02913105|144727661|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.97||||0.6035|TWO_SIDED|90.0|0.9|1.06|||ANCOVA|An unstructured variance-covariance structure was used.||LDL Cholesterol Friedwald: Day 28||1.06|0.90|0.6035
72598270|NCT02913105|144727661|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|1.06||||0.3261|TWO_SIDED|90.0|0.96|1.17|||ANCOVA|An unstructured variance-covariance structure was used.||LDL Cholesterol Friedwald: Day 42||1.17|0.96|0.3261
72598271|NCT02913105|144727661|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|1.04||||0.5246|TWO_SIDED|90.0|0.94|1.15|||ANCOVA|An unstructured variance-covariance structure was used.||LDL Cholesterol Friedwald: Day 56||1.15|0.94|0.5246
72415794|NCT01680328|144342427|SUPERIORITY_OR_OTHER||Least Squares Mean|3.7||||||95.0|0.6|6.7||||||Though the sample size was not based on any formal sample size or power calculations as no statistical tests were pre-specified to address the endpoints, a sample size of 80 completers was derived from a simulation study. Mean Difference in injection pain on VAS after injection of different volumes was calculated as least square mean estimate of the mean difference in injection pain.||6.7|0.6|
72415795|NCT01680328|144342427|SUPERIORITY_OR_OTHER||Least Squares Mean|0.4||||||95.0|-2.1|2.9||||||Though the sample size was not based on any formal sample size or power calculations as no statistical tests were pre-specified to address the endpoints, a sample size of 80 completers was derived from a simulation study. Mean difference in injection pain on VAS after injection at different speeds was calculated as least square mean estimate of the mean difference in injection pain on a VAS after injection at different speeds.||2.9|-2.1|
72598272|NCT02913105|144727661|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|1.02||||0.7519|TWO_SIDED|90.0|0.92|1.14|||ANCOVA|An unstructured variance-covariance structure was used.||LDL Cholesterol Friedwald: Day 84||1.14|0.92|0.7519
72598273|NCT02913105|144727661|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|1.0||||0.9577|TWO_SIDED|90.0|0.89|1.12|||ANCOVA|An unstructured variance-covariance structure was used.||LDL Cholesterol Friedwald: Day 112 (EOS)||1.12|0.89|0.9577
72598274|NCT02913105|144727661|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|1.1||||0.016|TWO_SIDED|90.0|1.03|1.18|||ANCOVA|An unstructured variance-covariance structure was used.||LDL Cholesterol Friedwald: Day 7||1.18|1.03|0.0160
72598275|NCT02913105|144727661|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|1.13||||0.0052|TWO_SIDED|90.0|1.05|1.21|||ANCOVA|An unstructured variance-covariance structure was used.||LDL Cholesterol Friedwald: Day 14||1.21|1.05|0.0052
72598276|NCT02913105|144727661|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|1.06||||0.1822|TWO_SIDED|90.0|0.99|1.15|||ANCOVA|An unstructured variance-covariance structure was used.||LDL Cholesterol Friedwald: Day 28||1.15|0.99|0.1822
72598277|NCT02913105|144727661|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|1.14||||0.0159|TWO_SIDED|90.0|1.04|1.24|||ANCOVA|An unstructured variance-covariance structure was used.||LDL Cholesterol Friedwald: Day 42||1.24|1.04|0.0159
72598278|NCT02913105|144727661|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|1.08||||0.1524|TWO_SIDED|90.0|0.99|1.19|||ANCOVA|An unstructured variance-covariance structure was used.||LDL Cholesterol Friedwald: Day 56||1.19|0.99|0.1524
72598279|NCT02913105|144727661|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|1.08||||0.1749|TWO_SIDED|90.0|0.98|1.2|||ANCOVA|An unstructured variance-covariance structure was used.||LDL Cholesterol Friedwald: Day 84||1.20|0.98|0.1749
72598280|NCT02913105|144727661|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|1.02||||0.7503|TWO_SIDED|90.0|0.92|1.13|||ANCOVA|An unstructured variance-covariance structure was used.||LDL Cholesterol Friedwald: Day 112 (EOS)||1.13|0.92|0.7503
72598281|NCT02913105|144727662|OTHER|Change from baseline was analyzed using an ANCOVA model which included effects for treatment, baseline and stratification factor (BMI group). BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Mean Difference (Final Values)|7.01|STANDARD_ERROR_OF_MEAN|5.52||0.2073|TWO_SIDED|90.0|-2.161|16.178|||ANCOVA|||||16.178|-2.161|0.2073
72598282|NCT02913105|144727662|SUPERIORITY|Change from baseline was analyzed using an ANCOVA model which included effects for treatment, baseline and stratification factor (BMI group). BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Mean Difference (Final Values)|7.23|STANDARD_ERROR_OF_MEAN|5.62||0.2014|TWO_SIDED|90.0|-2.106|16.563|||ANCOVA|||||16.563|-2.106|0.2014
72598283|NCT02913105|144727662|SUPERIORITY|Change from baseline was analyzed using an ANCOVA model which included effects for treatment, baseline and stratification factor (BMI group). BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Mean Difference (Final Values)|0.22|STANDARD_ERROR_OF_MEAN|4.93||0.9645|TWO_SIDED|90.0|-7.974|8.414|||ANCOVA|||||8.414|-7.974|0.9645
72598284|NCT01153009|144727686|SUPERIORITY_OR_OTHER||LS mean difference|-1.5|STANDARD_ERROR_OF_MEAN|1.21||0.224|TWO_SIDED|95.0|-3.86|0.91||Pre-specified sequential statistical testing procedure indicates that when p-value \>0.025, hierarchical testing stops for this dose and for subsequent endpoints in the sequence a nominal p-value is provided.|Mixed model for repeated measurements|MMRM ANCOVA with treatment, center, week, treatment-by-week interaction, baseline MADRS total score-by-week as fixed effects.||All statistical tests were 2-sided with the estimated P-values at the 5% level of significance. To control for multiplicity, a pre-specified sequential testing procedure was applied to compare 15 mg and 20 mg vortioxetine to placebo. Efficacy endpoints were tested for each dose in a sequential order at significance level 0.025; as soon as an endpoint was non-significant at 0.025, the testing procedure stopped for all subsequent endpoints.||0.91|-3.86|0.224
72598285|NCT01153009|144727686|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.8|STANDARD_ERROR_OF_MEAN|1.21||0.023|TWO_SIDED|95.0|-5.12|-0.38||Pre-specified sequential statistical testing procedure indicates that when p-value \<0.025, hierarchical testing continues for this dose.|Mixed model for repeated measurements|MMRM ANCOVA with treatment, center, week, treatment-by-week interaction, baseline MADRS total score-by-week as fixed effects.||||-0.38|-5.12|0.023
72598286|NCT01153009|144727686|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.1|STANDARD_ERROR_OF_MEAN|1.21|<|0.001|TWO_SIDED|95.0|-6.46|-1.69|||Mixed model for repeated measurements|MMRM ANCOVA with treatment, center, week, treatment-by-week interaction, baseline MADRS total score-by-week as fixed effects.||||-1.69|-6.46|<0.001
72598287|NCT01153009|144727687|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.249||||0.348|TWO_SIDED|95.0|0.786|1.984|||Regression, Logistic|P-value is from logistic regression with explanatory variables for treatment and Baseline MADRS score.||||1.984|0.786|0.348
72598288|NCT01153009|144727687|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.257||||0.332|TWO_SIDED|95.0|0.792|1.994||Pre-specified sequential statistical testing procedure indicates that when p-value \>0.025, hierarchical testing stops for this dose and for subsequent endpoints in the sequence a nominal p-value is provided.|Regression, Logistic|P-value is from logistic regression with explanatory variables for treatment and Baseline MADRS score.||||1.994|0.792|0.332
72598289|NCT01153009|144727687|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.991||||0.004|TWO_SIDED|95.0|1.25|3.171|||Regression, Logistic|P-value is from logistic regression with explanatory variables for treatment and Baseline MADRS score.||||3.171|1.250|0.004
72598290|NCT01153009|144727688|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.14||0.4|TWO_SIDED|95.0|-0.39|0.16|||Mixed model for repeated measurements|MMRM ANCOVA with treatment, center, week, treatment-by-week interaction, baseline CGI-S score-by-week as fixed effects.||||0.16|-0.39|0.400
72598291|NCT01153009|144727688|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.139||0.177|TWO_SIDED|95.0|-0.46|0.08|||Mixed model for repeated measurements|MMRM ANCOVA with treatment, center, week, treatment-by-week interaction, baseline CGI-S score-by-week as fixed effects.||||0.08|-0.46|0.177
72598292|NCT01153009|144727688|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.34|STANDARD_ERROR_OF_MEAN|0.139||0.014|TWO_SIDED|95.0|-0.61|-0.07|||Mixed model for repeated measurements|MMRM ANCOVA with treatment, center, week, treatment-by-week interaction, baseline CGI-S score-by-week as fixed effects.||||-0.07|-0.61|0.014
72598293|NCT01153009|144727689|SUPERIORITY_OR_OTHER||LS Mean Difference|0.93|STANDARD_ERROR_OF_MEAN|2.286||0.684|TWO_SIDED|95.0|-3.58|5.45|||Mixed model for repeated measurements|MMRM ANCOVA with treatment, center, week, treatment-by-week interaction, baseline MADRS total score-by-week as fixed effects.||||5.45|-3.58|0.684
72598294|NCT01153009|144727689|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.62|STANDARD_ERROR_OF_MEAN|2.419||0.797|TWO_SIDED|95.0|-5.4|4.15|||Mixed model for repeated measurements|MMRM ANCOVA with treatment, center, week, treatment-by-week interaction, baseline MADRS total score-by-week as fixed effects.||||4.15|-5.40|0.797
72598295|NCT01153009|144727689|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.05|STANDARD_ERROR_OF_MEAN|2.278||0.078|TWO_SIDED|95.0|-8.54|0.45|||Mixed model for repeated mesurements|MMRM ANCOVA with treatment, center, week, treatment-by-week interaction, baseline MADRS total score-by-week as fixed effects.||||0.45|-8.54|0.078
72598296|NCT01153009|144727690|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.053||||0.845|TWO_SIDED|95.0|0.625|1.775|||Regression, Logistic|Logistic regression with explanatory variables for treatment and Baseline MADRS score.||||1.775|0.625|0.845
72598297|NCT01153009|144727690|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.192||||0.503|TWO_SIDED|95.0|0.713|1.994|||Regression, Logistic|Logistic regression with explanatory variables for treatment and Baseline MADRS score.||||1.994|0.713|0.503
72598298|NCT01153009|144727690|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.098||||0.728|TWO_SIDED|95.0|0.648|1.86|||Regression, Logistic|Logistic regression with explanatory variables for treatment and Baseline MADRS score.||||1.860|0.648|0.728
72598299|NCT01153009|144727691|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|1.111||0.962|TWO_SIDED|95.0|-2.24|2.13|||Mixed model for repeated measurements|MMRM ANCOVA with treatment, center, week, treatment-by-week interaction, baseline SDS total score-by-week as fixed effects.||||2.13|-2.24|0.962
72598300|NCT01153009|144727691|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.88|STANDARD_ERROR_OF_MEAN|1.103||0.427|TWO_SIDED|95.0|-3.05|1.29|||Mixed model for repeated measurements|MMRM ANCOVA with treatment, center, week, treatment-by-week interaction, baseline SDS total score-by-week as fixed effects.||||1.29|-3.05|0.427
72598301|NCT01153009|144727691|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.99|STANDARD_ERROR_OF_MEAN|1.123||0.078|TWO_SIDED|95.0|-4.19|0.22|||Mixed model for repeated measurements|MMRM ANCOVA with treatment, center, week, treatment-by-week interaction, baseline SDS total score-by-week as fixed effects.||||0.22|-4.19|0.078
72598302|NCT00703326|144727702|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.88||||0.077|TWO_SIDED|95.0|0.75|1.01|||Stratified Log Rank (SLR)|SLR used Interactive Web Response System (IWRS) factors: prior taxane therapy, visceral metastasis, hormone receptor status and geographical regions.|HR with 95% confidence interval (CI) was estimated using a stratified Cox proportional hazards regression model using the IWRS stratification factors.|||1.01|0.75|0.077
72598303|NCT00703326|144727703|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.95||||0.487|TWO_SIDED|95.0|0.81|1.1||The gate-keeping strategy used to control overall type 1 error 0.05 (2-sided) or 0.025 (1-sided) to analyze progression-free survival (PFS) and OS. At final PFS analysis only if primary PFS test was significant would analysis of OS be inferential.|Stratified Log Rank (SLR)|SLR used Interactive Web Response System (IWRS) factors: prior taxane therapy, visceral metastasis, hormone receptor status and geographical regions.|HR with 95% confidence interval (CI) was estimated using a stratified Cox proportional hazards regression model using the IWRS stratification factors.|||1.10|0.81|0.487
72598304|NCT00703326|144727704|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.85||||0.033|TWO_SIDED|95.0|0.73|0.99|||Stratified Log Rank (SLR)|SLR used Interactive Web Response System (IWRS) factors: prior taxane therapy, visceral metastasis, hormone receptor status and geographical regions.|HR with 95% confidence interval (CI) was estimated using a stratified Cox proportional hazards regression model using the IWRS stratification factors.|||0.99|0.73|0.033
72415796|NCT01680328|144342427|SUPERIORITY_OR_OTHER||Least Squares Mean|-0.4||||||95.0|-2.7|1.9||||||Though the sample size was not based on any formal sample size or power calculations as no statistical tests were pre-specified to address the endpoints, a sample size of 80 completers was derived from a simulation study. Mean difference in injection pain on VAS after injection at different speeds was calculated as least square mean estimate of the mean difference in injection pain on a VAS after injection at different speeds.||1.9|-2.7|
72598305|NCT00703326|144727705|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.33||||0.027|TWO_SIDED|95.0|1.03|1.71|||Stratified Cochran-Mantel-Haenszel(SCMH)|SCMH used Interactive Web Response System (IWRS) factors: prior taxane therapy, visceral metastasis, hormone receptor status and geographical regions.|Stratified odds ratio was calculated considering the IWRS stratification factors.|||1.71|1.03|0.027
72598306|NCT00703326|144727706|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.84||||0.15|TWO_SIDED|95.0|0.67|1.06|||Stratified Log Rank (SLR)|SLR used Interactive Web Response System (IWRS) factors: prior taxane therapy, visceral metastasis, hormone receptor status and geographical regions.|HR with 95% confidence interval (CI) was estimated using a stratified Cox proportional hazards regression model using the IWRS stratification factors.|||1.06|0.67|0.150
72415797|NCT01680328|144342427|SUPERIORITY_OR_OTHER||Least Squares Mean|9.0||||||95.0|6.7|11.3||||||Though the sample size was not based on any formal sample size or power calculations as no statistical tests were pre-specified to address the endpoints, a sample size of 80 completers was derived from a simulation study. The mean difference in injection pain on a VAS (mm) between the thighs and abdomen was calculated as the least square mean estimate of the mean difference in injection pain on a VAS (mm) between the thighs and abdomen.||11.3|6.7|
72598307|NCT00703326|144727707|SUPERIORITY_OR_OTHER_LEGACY|||||||0.539||||||P-value is for end of therapy. Analysis of covariance (ANCOVA) adjusted for baseline score was used to compare the 2 treatment arms.|ANCOVA|||||||0.539
72598308|NCT02242019|144727712|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||t-test, 2 sided|||||||<0.0001
72598309|NCT02242019|144727713|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||t-test, 2 sided|||||||<0.0001
72598310|NCT03214679|144727737|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<.001
72598311|NCT01601067|144727742|SUPERIORITY|||||||0.002|||||||Mixed Models Analysis|||||||.002
72598312|NCT01601067|144727743|SUPERIORITY|||||||0.91||||||heavy drinking days|Mixed Models Analysis|||||||.91
72598313|NCT02771860|144727754|SUPERIORITY||Mean Difference (Final Values)|8.9||||0.024|TWO_SIDED|95.0|1.0|16.9|||GEE|||Comparison between groups was done by Generalized Estimation Equations at joint level, accounting for within-patient clustering and adjusted for baseline unbalances. Missing values were imputed according to a predefined imputation model, including randomization group, baseline value and values at other time points available, presence of baseline inflammation, baseline number of affected joints.||16.9|1.0|0.024
72598314|NCT02771860|144727755|SUPERIORITY||Odds Ratio (OR)|0.23|||<|0.001|TWO_SIDED|95.0|0.11|0.5|||Regression, Logistic|||||0.50|0.11|<0.001
72598315|NCT02771860|144727756|SUPERIORITY||Mean Difference (Final Values)|14.3||||0.003|TWO_SIDED|95.0|4.6|24.0|||GEE|||Comparison between groups was done by Generalized Estimation Equations at joint level, accounting for within-patient clustering and adjusted for baseline unbalances. Missing values were imputed according to a predefined imputation model, including randomization group, baseline value and values at other time points available, presence of baseline inflammation, baseline number of affected joints.||24.0|4.6|0.003
72598316|NCT02412878|144727771|SUPERIORITY||Odds Ratio (OR)|2.485|||<|0.0001|TWO_SIDED|95.0|1.716|3.598||Progression-free survival, overall response, and overall survival were tested using a fixed sequence hierarchical testing procedure to control the family-wise type I error rate below one-sided 0.025 level.|Cochran-Mantel-Haenszel|One-sided p-value from CMH test stratified by the randomization factors (ISS stage at study entry, refractory to bortezomib treatment, and age).|Odds ratio (once weekly carfilzomib 20/70 mg/m²/ twice weekly carfilzomib 20/27 mg/m²) was calculated using the Mantel-Haenszel method stratified by the randomization stratification factors.|||3.598|1.716|< 0.0001
72598317|NCT02412878|144727771|SUPERIORITY||Odds Ratio (OR)|2.466|||<|0.0001|TWO_SIDED|95.0|1.707|3.563|||Fisher Exact||Odds ratio (once weekly carfilzomib 20/70 mg/m²/ twice weekly carfilzomib 20/27 mg/m²) was calculated using the Mantel-Haenszel method.|||3.563|1.707|<0.0001
72598318|NCT02412878|144727772|SUPERIORITY||Hazard Ratio (HR)|0.693||||0.0014|TWO_SIDED|95.0|0.544|0.883||Progression-free survival, overall response rate, and overall survival were tested using a fixed sequence hierarchical testing procedure to control the family-wise type I error rate below one-sided 0.025 level.|Log Rank|One-sided stratified log-rank test, stratified by the randomization factors (ISS stage at study entry, refractory to bortezomib treatment, and age).|Hazard ratio (once weekly carfilzomib 20/70 mg/m²/ twice weekly carfilzomib 20/27 mg/m²) was estimated using a Cox proportional hazards model stratified by the randomization stratification factors.|To ensure proper control of type I error, analysis of PFS was performed under a group sequential design framework with the stopping boundaries constructed using the Lan-DeMets spending function with an O'Brien-Fleming approach. The inferential comparison between the 2 treatment groups for PFS used the 1-sided log-rank test stratified by the randomization stratification factors. A 1-sided p-value was compared against the prespecified adjusted alpha value of 0.011 to determine significance.||0.883|0.544|0.0014
72598319|NCT02412878|144727772|SUPERIORITY||Hazard Ratio (HR)|0.72||||0.0033|TWO_SIDED|95.0|0.567|0.913|||Log Rank|One-sided unstratified log-rank test|Hazard ratio (once weekly carfilzomib 20/70 mg/m²/ twice weekly carfilzomib 20/27 mg/m²) was estimated using an unstratified Cox proportional hazards model.|||0.913|0.567|0.0033
72598320|NCT02412878|144727773|SUPERIORITY||Hazard Ratio (HR)|0.8||||0.107|TWO_SIDED|95.0|0.563|1.138||Progression-free survival, overall response, and overall survival were tested using a fixed sequence hierarchical testing procedure to control the family-wise type I error rate below one-sided 0.025 level.|Log Rank|One-sided stratified log-rank test, stratified by the randomization factors (ISS stage at study entry, refractory to bortezomib treatment, and age).|Hazard ratio (once weekly carfilzomib 20/70 mg/m²/ twice weekly carfilzomib 20/27 mg/m²) was estimated using a Cox proportional hazards model stratified by the randomization stratification factors.|||1.138|0.563|0.1070
72598321|NCT02412878|144727773|SUPERIORITY||Hazard Ratio (HR)|0.82||||0.1326|TWO_SIDED|95.0|0.578|1.164|||Log Rank|One-sided unstratified log-rank test|Hazard ratio (once weekly carfilzomib 20/70 mg/m²/ twice weekly carfilzomib 20/27 mg/m²) was estimated using an unstratified Cox proportional hazards model.|||1.164|0.578|0.1326
72598322|NCT01212159|144727842|SUPERIORITY_OR_OTHER|||||||0.391|TWO_SIDED|||||Comparison of mean reduction in LDL cholesterol between no monitor (control) and monitor (intervention) groups|t-test, 2 sided|||Paired t-test analysis of 6 month change in LDL cholesterol for no monitor and self monitor groups Independent sample t-test to compare ldl change between groups||||0.391
72598323|NCT05025332|144727848|OTHER|||||||0.0039|||||||Wilcoxon Signed rank|null median = 4, not 0||Descriptive statistics were used to summarize the data. For total scores, waterfall plots and histograms/bar charts were created at the EOT visit with plots for all participants.||||.0039
72598324|NCT05025332|144727849|OTHER|||||||0.0234|||||||Wilcoxon Signed rank|null median = 4, not 0||Descriptive statistics were used to summarize the data. For total scores, waterfall plots, and histograms were created at the EOT visit with plots for all participants.||||0.0234
72598325|NCT05025332|144727850|OTHER|Change from baseline||||||0.0313|||||||Wilcoxon Signed rank|||Efficacy endpoints were analyzed using a Wilcoxon signed rank test on the paired participant data from baseline to EOT (Visit 16), when applicable. Baseline values were based on the average non-missing values of visits 1, 2, and 3 for assessments collected at more than one visit during the Screening/Baseline period.||||0.0313
72598326|NCT05025332|144727851|OTHER|Change from baseline||||||0.0039|||||||Wilcoxon Signed rank|||Efficacy endpoints were analyzed using a Wilcoxon signed rank test on the paired participant data from baseline to EOT (Visit 16), when applicable. Baseline values were based on the average non-missing values of visits 1, 2, and 3 for assessments collected at more than one visit during the Screening/Baseline period.||||0.0039
72598327|NCT05025332|144727852|OTHER|change from baseline||||||0.1934|||||||Wilcoxon Signed rank|||Efficacy endpoints were analyzed using a Wilcoxon signed rank test on the paired participant data from baseline to EOT (Visit 16), when applicable. Baseline values were based on the average non-missing values of visits 1, 2, and 3 for assessments collected at more than one visit during the Screening/Baseline period.||||0.1934
72598328|NCT05025332|144727853|OTHER|Change from baseline||||||0.748|||||||Wilcoxon Signed rank|||Efficacy endpoints were analyzed using a Wilcoxon signed rank test on the paired participant data from baseline to EOT (Visit 16), when applicable. Baseline values were based on the average non-missing values of visits 1, 2, and 3 for assessments collected at more than one visit during the Screening/Baseline period.||||0.7480
72598329|NCT05025332|144727854|OTHER|Change from baseline||||||0.3203|||||||Wilcoxon Signed rank|||Efficacy endpoints were analyzed using a Wilcoxon signed rank test on the paired participant data from baseline to EOT (Visit 16), when applicable. Baseline values were based on the average non-missing values of visits 1, 2, and 3 for assessments collected at more than one visit during the Screening/Baseline period.||||0.3203
72598330|NCT05025332|144727855|OTHER|change from baseline||||||0.3574|||||||Wilcoxon Signed rank|||Efficacy endpoints were analyzed using a Wilcoxon signed rank test on the paired participant data from baseline to EOT (Visit 16), when applicable. Baseline values were based on the average non-missing values of visits 1, 2, and 3 for assessments collected at more than one visit during the Screening/Baseline period.||||0.3574
72598331|NCT05025332|144727856|OTHER|Change from baseline||||||0.4131|||||||Wilcoxon Signed rank|||Efficacy endpoints were analyzed using a Wilcoxon signed rank test on the paired participant data from baseline to EOT (Visit 16), when applicable. Baseline values were based on the average non-missing values of visits 1, 2, and 3 for assessments collected at more than one visit during the Screening/Baseline period.||||0.4131
72598332|NCT05025332|144727857|OTHER|change from baseline||||||0.9063|||||||Wilcoxon Signed rank|||Efficacy endpoints were analyzed using a Wilcoxon signed rank test on the paired participant data from baseline to EOT (Visit 16), when applicable. Baseline values were based on the average non-missing values of visits 1, 2, and 3 for assessments collected at more than one visit during the Screening/Baseline period.||||0.9063
72598333|NCT05025332|144727858|OTHER|Change from baseline||||||1|||||||Wilcoxon Signed rank|||Efficacy endpoints were analyzed using a Wilcoxon signed rank test on the paired participant data from baseline to EOT (Visit 16), when applicable. Baseline values were based on the average non-missing values of visits 1, 2, and 3 for assessments collected at more than one visit during the Screening/Baseline period.||||1.00
72598334|NCT05025332|144727859|OTHER|Change from baseline||||||0.7002|||||||Wilcoxon Signed rank|||Efficacy endpoints were analyzed using a Wilcoxon signed rank test on the paired participant data from baseline to EOT (Visit 16), when applicable. Baseline values were based on the average non-missing values of visits 1, 2, and 3 for assessments collected at more than one visit during the Screening/Baseline period.||||0.7002
72598335|NCT05025332|144727860|OTHER|Change from baseline||||||0.375|||||||Wilcoxon Signed rank|||Efficacy endpoints were analyzed using a Wilcoxon signed rank test on the paired participant data from baseline to EOT (Visit 16), when applicable. Baseline values were based on the average non-missing values of visits 1, 2, and 3 for assessments collected at more than one visit during the Screening/Baseline period.||||0.3750
72598336|NCT05025332|144727861|OTHER|||||||0.7695|||||||Wilcoxon Signed rank|||Efficacy endpoints were analyzed using a Wilcoxon signed rank test on the paired participant data from baseline to EOT (Visit 16), when applicable. Baseline values were based on the average non-missing values of visits 1, 2, and 3 for assessments collected at more than one visit during the Screening/Baseline period.||||0.7695
72415798|NCT01680328|144342428|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.8||||||95.0|0.5|1.4|||Odds ratio (OR)|||Acceptance of pain was rated subjectively as yes or no by the subject after each injection. The odds are calculated as 'no versus yes', and 'larger volume versus smaller', so that an odds ratio above 1 corresponds to a higher frequency of unacceptable pain for the larger volume - i.e. a worse condition. The odd ratios for unacceptable injection pain are based on a statistical model for all acceptance pain data.||1.4|0.5|
72598337|NCT05025332|144727862|OTHER|||||||0.2402|||||||Wilcoxon Signed rank|||Efficacy endpoints were analyzed using a Wilcoxon signed rank test on the paired participant data from baseline to EOT (Visit 16), when applicable. Baseline values were based on the average non-missing values of visits 1, 2, and 3 for assessments collected at more than one visit during the Screening/Baseline period.||||0.2402
72598338|NCT01306214|144727863|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.44|STANDARD_ERROR_OF_MEAN|0.08|<|0.0001|TWO_SIDED|97.5|-0.61|-0.27||Hierarchical testing to adjust for multiple comparisons within each dose level, alpha split equally between the doses (2.5%). Empagliflozin versus placebo change from baseline in HbA1c at week 18 was the first step in each hierarchical sequence.|ANCOVA|ANCOVA Model includes baseline HbA1c as a covariate and baseline eGFR, geographic region, baseline background medication, treatment as fixed effects.|Estimated value = Adjusted mean of Empagliflozin 10 mg - Adjusted mean of placebo.|"For the primary endpoint, the testing of the superiority hypothesis versus placebo was:~Hypothesis test:~H0: No difference in change from baseline to Week 18 in HbA1c (%) between Empagliflozin 10 mg and placebo Ha: A difference in change from baseline to Week 18 in HbA1c (%) between Empagliflozin 10 mg and placebo"||-0.27|-0.61|<0.0001
72598339|NCT01306214|144727863|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.52|STANDARD_ERROR_OF_MEAN|0.07|<|0.0001|TWO_SIDED|97.5|-0.69|-0.35||Hierarchical testing to adjust for multiple comparisons within each dose level, alpha split equally between the doses (2.5%). Empagliflozin versus placebo change from baseline in HbA1c at week 18 was the first step in each hierarchical sequence.|ANCOVA|ANCOVA Model includes baseline HbA1c as a covariate and baseline eGFR, geographic region, baseline background medication, treatment as fixed effects.|Estimated value = Adjusted mean of Empagliflozin 25 mg - Adjusted mean of placebo|"For the primary endpoint, the testing of the superiority hypothesis versus placebo was:~H0: No difference in change from baseline to Week 18 in HbA1c (%) between Empagliflozin 25 mg and placebo Ha: A difference in change from baseline to Week 18 in HbA1c (%) between Empagliflozin 25 mg and placebo"||-0.35|-0.69|<0.0001
72598340|NCT01306214|144727864|SUPERIORITY_OR_OTHER||Adjusted mean difference|-8.83|STANDARD_ERROR_OF_MEAN|3.05||0.004|TWO_SIDED|97.5|-15.69|-1.97||Hierarchical testing adjusted for multiple comparisons within each dose level, alpha split equally between the doses (2.5%). Empagliflozin versus placebo change from baseline in insulin dose at week 52 was the second step in hierarchical sequence.|ANCOVA|Model - Covariates: baseline insulin daily dose,baseline HbA1c Fixed effects: baseline eGFR, region, baseline background medication, treatment|Estimated value = Adjusted mean of empagliflozin 10 mg - Adjusted mean of placebo|"Hypothesis test:~H0: No difference in change from baseline to Week 52 in insulin dose (IU/day) between Empagliflozin 10 mg and placebo Ha: A difference in change from baseline to Week 52 in insulin dose (IU/day) between Empagliflozin 10 mg and placebo"||-1.97|-15.69|0.004
72598341|NCT01306214|144727864|SUPERIORITY_OR_OTHER||Adjusted mean difference|-11.22|STANDARD_ERROR_OF_MEAN|3.05||0.0003|TWO_SIDED|97.5|-18.09|-4.36||Hierarchical testing adjusted for multiple comparisons within each dose level, alpha split equally between the doses (2.5%). Empagliflozin versus placebo change from baseline in insulin dose at week 52 was the second step in hierarchical sequence.|ANCOVA|Model - Covariates: baseline insulin daily dose,baseline HbA1c Fixed effects: baseline eGFR, region, baseline background medication, treatment|Estimated value = Adjusted mean of Empagliflozin 25 mg - Adjusted mean of placebo.|"Hypothesis test:~H0: No difference in change from baseline to Week 52 in insulin dose (IU/day) between Empagliflozin 25 mg and placebo Ha : A difference in change from baseline to Week 52 in insulin dose (IU/day) between Empagliflozin 25 mg and placebo"||-4.36|-18.09|0.0003
72598342|NCT01306214|144727865|SUPERIORITY_OR_OTHER||Adjusted mean difference|-2.39|STANDARD_ERROR_OF_MEAN|0.51|<|0.0001|TWO_SIDED|97.5|-3.54|-1.24||Hierarchical testing adjusted for multiple comparisons within each dose level, alpha split equally between the doses (2.5%). Empagliflozin versus placebo change from baseline in body weight at week 52 was the third step in hierarchical sequence.|ANCOVA|Model includes baseline weight, baseline HbA1c as covariates and baseline eGFR, region, baseline background medication, treatment as fixed effects.|Estimated value = Adjusted mean of empagliflozin 10 mg - Adjusted mean of placebo|"Hypothesis test:~H0: No difference in change from baseline to Week 52 in body weight (kg) between Empagliflozin 10 mg and placebo Ha : A difference in change from baseline to Week 52 in body weight (kg) between Empagliflozin 10 mg and placebo"||-1.24|-3.54|<0.0001
72598343|NCT01306214|144727865|SUPERIORITY_OR_OTHER||Adjusted mean difference|-2.48|STANDARD_ERROR_OF_MEAN|0.51|<|0.0001|TWO_SIDED|97.5|-3.63|-1.33||Hierarchical testing adjusted for multiple comparisons within each dose level, alpha split equally between the doses (2.5%). Empagliflozin versus placebo change from baseline in body weight at week 52 was the third step in hierarchical sequence.|ANCOVA|Model includes baseline weight, baseline HbA1c as covariates and baseline eGFR, region, baseline background medication, treatment as fixed effects.|Estimated value = Adjusted mean of empagliflozin 25 mg - Adjusted mean of placebo|hypothesis test: H0: No difference in change from baseline to Week 52 in body weight (kg) between Empagliflozin 25 mg and placebo Ha: A difference in change from baseline to Week 52 in body weight (kg) between Empagliflozin 25 mg and placebo||-1.33|-3.63|<0.0001
72598344|NCT01306214|144727866|NON_INFERIORITY_OR_EQUIVALENCE|The non- inferiority margin was 0.3%, one-sided.|Adjusted mean difference|-0.38|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001|TWO_SIDED|97.5|-0.62|-0.13||Hierarchical testing adjusted for multiple comparisons within each dose, alpha split between the doses (2.5%). Empagliflozin versus placebo change from baseline in HbA1c at week 52 was the 4th step (non-inferiority) and 5th step (superiority).|ANCOVA|Model includes baseline HbA1c as covariate and baseline eGFR, geographical region, baseline background medication, treatment as fixed effects.|Estimated value = Adjusted mean of empagliflozin 10 mg - Adjusted mean of placebo|H0: Difference in change from baseline to Week 52 in HbA1c (%) between empagliflozin 10 mg and placebo \>0.3 Ha: Difference in change from baseline to Week 52 in HbA1c (%) between empagliflozin 10 mg and placebo ≤0.3||-0.13|-0.62|<0.0001
72598345|NCT01306214|144727866|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.38|STANDARD_ERROR_OF_MEAN|0.11||0.0005|TWO_SIDED|97.5|-0.62|-0.13||Hierarchical testing adjusted for multiple comparisons within each dose, alpha split between the doses (2.5%). Empagliflozin versus placebo change from baseline in HbA1c at week 52 was the 4th step (non-inferiority) and 5th step (superiority).|ANCOVA|Model includes baseline HbA1c as covariate and baseline eGFR, geographical region, baseline background medication, treatment as fixed effects.|Estimated value = Adjusted mean of empagliflozin 10 mg - Adjusted mean of placebo|"Hypothesis test:~H0: No difference in change from baseline to Week 52 in HbA1c (%) between Empagliflozin 10 mg and placebo Ha : A difference in change from baseline to Week 52 in HbA1c (%) between Empagliflozin 10 mg and placebo"||-0.13|-0.62|0.0005
72415799|NCT01680328|144342428|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.1||||||95.0|1.2|3.5||||||Acceptance of pain was rated subjectively as yes or no by the subject after each injection. The odds are calculated as 'no versus yes', and 'larger volume versus smaller', so that an odds ratio above 1 corresponds to a higher frequency of unacceptable pain for the larger volume - i.e. a worse condition. The odd ratios for unacceptable injection pain are based on a statistical model for all acceptance pain data.||3.5|1.2|
72598346|NCT01306214|144727866|NON_INFERIORITY_OR_EQUIVALENCE|The non- inferiority margin was 0.3%, one-sided.|Adjusted mean difference|-0.46|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001|TWO_SIDED|97.5|-0.7|-0.22||Hierarchical testing adjusted for multiple comparisons within each dose, alpha split between the doses (2.5%). Empagliflozin versus placebo change from baseline in HbA1c at week 52 was the 4th step (non-inferiority) and 5th step (superiority).|ANCOVA|Model includes baseline HbA1c as covariate and baseline eGFR, geographical region, baseline background medication, treatment as fixed effects.|Estimated value = Adjusted mean of empagliflozin 25 mg - Adjusted mean of placebo|H013: Difference in change from baseline to Week 52 in HbA1c (%) between empagliflozin 25 mg and placebo \>0.3 Ha13: Difference in change from baseline to Week 52 in HbA1c (%) between empagliflozin 25 mg and placebo ≤0.3||-0.22|-0.70|<0.0001
72598347|NCT01306214|144727866|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.46|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001|TWO_SIDED|97.5|-0.7|-0.22||Hierarchical testing adjusted for multiple comparisons within each dose, alpha split between the doses (2.5%). Empagliflozin versus placebo change from baseline in HbA1c at week 52 was the 4th step (non-inferiority) and 5th step (superiority).|ANCOVA|Model includes baseline HbA1c as covariate and baseline eGFR, geographical region, baseline background medication, treatment as fixed effects.|Estimated value = Adjusted mean of empagliflozin 25 mg - Adjusted mean of placebo|"Hypothesis test:~H0: No difference in change from baseline to Week 52 in HbA1c (%) between Empagliflozin 25 mg and placebo Ha : A difference in change from baseline to Week 52 in HbA1c (%) between Empagliflozin 25 mg and placebo"||-0.22|-0.70|<0.0001
72598348|NCT04575584|144727872|SUPERIORITY||Hazard Ratio (HR)|0.99||||0.562|TWO_SIDED|95.0|0.68|1.45|||Log Rank||Based on Cox regression model with Efron's method of tie handling|||1.45|0.68|0.5620
72598349|NCT04575584|144727872|SUPERIORITY||Hazard Ratio (HR)|1.13||||0.3145|TWO_SIDED|95.0|0.78|1.65|||Log Rank||Based on Cox regression model with Efron's method of tie handling|||1.65|0.78|0.3145
72598350|NCT04575584|144727872|SUPERIORITY||Hazard Ratio (HR)|1.01||||0.4894|TWO_SIDED|95.0|0.69|1.47|||Log Rank||Based on Cox regression model with Efron's method of tie handling|||1.47|0.69|0.4894
72598351|NCT04575584|144727875|SUPERIORITY||Mean Difference (Final Values)|4.1||||0.1642|TWO_SIDED|95.0|-2.3|12.1|||Miettinen and Nurminen method||Miettinen and Nurminen method. Unknown Day 29 survival status treated as failure.|||12.1|-2.3|0.1642
72598352|NCT04575584|144727875|SUPERIORITY||Mean Difference (Final Values)|5.5||||0.09|TWO_SIDED|95.0|-1.1|13.9|||Miettinen and Nurminen method||Miettinen and Nurminen method. Unknown Day 29 survival status treated as failure.|||13.9|-1.1|0.0900
72598353|NCT04575584|144727875|SUPERIORITY||Mean Difference (Final Values)|4.2||||0.1594|TWO_SIDED|95.0|-2.3|12.3|||Miettinen and Nurminen method||Miettinen and Nurminen method. Unknown Day 29 survival status treated as failure.|||12.3|-2.3|0.1594
72598354|NCT04575584|144727876|SUPERIORITY||Odds Ratio (OR)|1.31||||0.3623|TWO_SIDED|95.0|0.73|2.35|||Wald Chi-Square||Based on the proportional odds model with Pulmonary score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. Confidence intervals (CIs) are based on Wald Chi-Square Test.|||2.35|0.73|0.3623
72598355|NCT04575584|144727876|SUPERIORITY||Odds Ratio (OR)|1.18||||0.5714|TWO_SIDED|95.0|0.66|2.12|||Wald Chi-Square||Based on the proportional odds model with Pulmonary score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|||2.12|0.66|0.5714
72598356|NCT04575584|144727876|SUPERIORITY||Odds Ratio (OR)|0.97||||0.9313|TWO_SIDED|95.0|0.54|1.75|||Wald Chi-Square||Based on the proportional odds model with Pulmonary score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|||1.75|0.54|0.9313
72598357|NCT04575584|144727877|SUPERIORITY||Odds Ratio (OR)|1.27||||0.4398|TWO_SIDED|95.0|0.7|2.3|||Wald Chi-Square||Based on the proportional odds model with Pulmonary score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|||2.30|0.70|0.4398
72415800|NCT01680328|144342428|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.1||||||95.0|1.4|3.0||||||Acceptance of pain was rated subjectively as yes or no by the subject after each injection. The odds are calculated as 'no versus yes', and 'larger volume versus smaller', so that an odds ratio above 1 corresponds to a higher frequency of unacceptable pain for the larger volume - i.e. a worse condition. The odd ratios for unacceptable injection pain are based on a statistical model for all acceptance pain data.||3.0|1.4|
72598358|NCT04575584|144727877|SUPERIORITY||Odds Ratio (OR)|0.86||||0.6277|TWO_SIDED|95.0|0.47|1.57|||Wald Chi-Square||Based on the proportional odds model with Pulmonary score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|||1.57|0.47|0.6277
72598359|NCT04575584|144727877|SUPERIORITY||Odds Ratio (OR)|0.89||||0.7069|TWO_SIDED|95.0|0.49|1.62|||Wald Chi-Square||Based on the proportional odds model with Pulmonary score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|||1.62|0.49|0.7069
72598360|NCT04575584|144727878|SUPERIORITY||Odds Ratio (OR)|1.48||||0.2422|TWO_SIDED|95.0|0.77|2.85|||Wald Chi-Square||Based on the proportional odds model with Pulmonary score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|||2.85|0.77|0.2422
72598361|NCT04575584|144727878|SUPERIORITY||Odds Ratio (OR)|1.27||||0.4789|TWO_SIDED|95.0|0.66|2.44|||Wald Chi-Square||Based on the proportional odds model with Pulmonary score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|||2.44|0.66|0.4789
72598362|NCT04575584|144727878|SUPERIORITY||Odds Ratio (OR)|0.85||||0.6052|TWO_SIDED|95.0|0.45|1.59|||Wald Chi-Square||Based on the proportional odds model with Pulmonary score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|||1.59|0.45|0.6052
72598363|NCT04575584|144727879|SUPERIORITY||Odds Ratio (OR)|1.47||||0.2644|TWO_SIDED|95.0|0.75|2.88|||Wald Chi-Square||Based on the proportional odds model with Pulmonary score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|||2.88|0.75|0.2644
72598364|NCT04575584|144727879|SUPERIORITY||Odds Ratio (OR)|1.55||||0.2184|TWO_SIDED|95.0|0.77|3.14|||Wald Chi-Square||Based on the proportional odds model with Pulmonary score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|||3.14|0.77|0.2184
72598365|NCT04575584|144727879|SUPERIORITY||Odds Ratio (OR)|1.01||||0.9771|TWO_SIDED|95.0|0.53|1.94|||Wald Chi-Square||Based on the proportional odds model with Pulmonary score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|||1.94|0.53|0.9771
72598366|NCT04575584|144727880|SUPERIORITY||Odds Ratio (OR)|0.97||||0.9945|TWO_SIDED|95.0|0.46|2.06|||Wald Chi-Square||Based on the proportional odds model with Pulmonary score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|||2.06|0.46|0.9945
72598367|NCT04575584|144727880|SUPERIORITY||Odds Ratio (OR)|1.5||||0.3227|TWO_SIDED|95.0|0.67|3.37|||Wald Chi-Square||Based on the proportional odds model with Pulmonary score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|||3.37|0.67|0.3227
72598368|NCT04575584|144727880|SUPERIORITY||Odds Ratio (OR)|0.79||||0.52|TWO_SIDED|95.0|0.39|1.61|||Wald Chi-Square||Based on the proportional odds model with Pulmonary score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|||1.61|0.39|0.5200
72598369|NCT04575584|144727881|SUPERIORITY||Odds Ratio (OR)|1.25||||0.4472|TWO_SIDED|95.0|0.7|2.25|||Wald Chi-Square||Based on the proportional odds model with Pulmonary+ score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|||2.25|0.70|0.4472
72598370|NCT04575584|144727881|SUPERIORITY||Odds Ratio (OR)|1.18||||0.5714|TWO_SIDED|95.0|0.66|2.12|||Wald Chi-Square||Based on the proportional odds model with Pulmonary+ score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|||2.12|0.66|0.5714
72598371|NCT04575584|144727881|SUPERIORITY||Odds Ratio (OR)|0.97||||0.9313|TWO_SIDED|95.0|0.54|1.75|||Wald Chi-Square||Based on the proportional odds model with Pulmonary+ score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|||1.75|0.54|0.9313
72598372|NCT04575584|144727882|SUPERIORITY||Odds Ratio (OR)|1.22||||0.5222|TWO_SIDED|95.0|0.67|2.21|||Wald Chi-Square||Based on the proportional odds model with Pulmonary+ score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|||2.21|0.67|0.5222
72598373|NCT04575584|144727882|SUPERIORITY||Odds Ratio (OR)|0.86||||0.6277|TWO_SIDED|95.0|0.47|1.57|||Wald Chi-Square||Based on the proportional odds model with Pulmonary+ score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|||1.57|0.47|0.6277
72598374|NCT04575584|144727882|SUPERIORITY||Odds Ratio (OR)|0.89||||0.7069|TWO_SIDED|95.0|0.49|1.62|||Wald Chi-Square||Based on the proportional odds model with Pulmonary+ score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|||1.62|0.49|0.7069
72598375|NCT04575584|144727883|SUPERIORITY||Odds Ratio (OR)|1.46||||0.2627|TWO_SIDED|95.0|0.75|2.8|||Wald Chi-Square||Based on the proportional odds model with Pulmonary+ score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|||2.80|0.75|0.2627
72598376|NCT04575584|144727883|SUPERIORITY||Odds Ratio (OR)|1.27||||0.4789|TWO_SIDED|95.0|0.66|2.44|||Wald Chi-Square||Based on the proportional odds model with Pulmonary+ score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|||2.44|0.66|0.4789
72598377|NCT04575584|144727883|SUPERIORITY||Odds Ratio (OR)|0.84||||0.5938|TWO_SIDED|95.0|0.45|1.58|||Wald Chi-Square||Based on the proportional odds model with Pulmonary+ score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|||1.58|0.45|0.5938
72598378|NCT04575584|144727884|SUPERIORITY||Odds Ratio (OR)|1.47||||0.2644|TWO_SIDED|95.0|0.75|2.88|||Wald Chi-Square||Based on the proportional odds model with Pulmonary+ score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|||2.88|0.75|0.2644
72598379|NCT04575584|144727884|SUPERIORITY||Odds Ratio (OR)|1.55||||0.2184|TWO_SIDED|95.0|0.77|3.14|||Wald Chi-Square||Based on the proportional odds model with Pulmonary+ score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|||3.14|0.77|0.2184
72598380|NCT04575584|144727884|SUPERIORITY||Odds Ratio (OR)|1.01||||0.9771|TWO_SIDED|95.0|0.53|1.94|||Wald Chi-Square||Based on the proportional odds model with Pulmonary+ score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|||1.94|0.53|0.9771
72598381|NCT04575584|144727885|SUPERIORITY||Odds Ratio (OR)|0.97||||0.9445|TWO_SIDED|95.0|0.46|2.06|||Wald Chi-Square||Based on the proportional odds model with Pulmonary+ score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|||2.06|0.46|0.9445
72598382|NCT04575584|144727885|SUPERIORITY||Odds Ratio (OR)|1.5||||0.3227|TWO_SIDED|95.0|0.67|3.37|||Wald Chi-Square||Based on the proportional odds model with Pulmonary+ score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|||3.37|0.67|0.3227
72598383|NCT04575584|144727885|SUPERIORITY||Odds Ratio (OR)|0.79||||0.52|TWO_SIDED|95.0|0.39|1.61|||Wald Chi-Square||Based on the proportional odds model with Pulmonary+ score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|||1.61|0.39|0.5200
72598384|NCT04575584|144727886|SUPERIORITY||Odds Ratio (OR)|1.07||||0.8732|TWO_SIDED|95.0|0.46|2.47|||Wald Chi-Square||Proportional odds model with National Early Warning Score (NEWS) categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|||2.47|0.46|0.8732
72598385|NCT04575584|144727886|SUPERIORITY||Odds Ratio (OR)|0.54||||0.1277|TWO_SIDED|95.0|0.25|1.19|||Wald Chi-square||Proportional odds model with NEWS categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|||1.19|0.25|0.1277
72598386|NCT04575584|144727886|SUPERIORITY||Odds Ratio (OR)|0.73||||0.4326|TWO_SIDED|95.0|0.33|1.61|||Wald Chi-Square||Proportional odds model with NEWS categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|||1.61|0.33|0.4326
72598387|NCT04575584|144727887|SUPERIORITY||Odds Ratio (OR)|1.2||||0.683|TWO_SIDED|95.0|0.5|2.88|||Wald Chi-Square||Based on the proportional odds model with WHO-11 score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|||2.88|0.50|0.6830
72598388|NCT04575584|144727887|SUPERIORITY||Odds Ratio (OR)|1.0||||1|TWO_SIDED|95.0|0.42|2.39|||Wald Chi-Square||Based on the proportional odds model with WHO-11 score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|||2.39|0.42|1.000
72598389|NCT04575584|144727887|SUPERIORITY||Odds Ratio (OR)|0.9||||0.8244|TWO_SIDED|95.0|0.37|2.2|||Wald Chi-Square||Based on the proportional odds model with WHO-11 score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|||2.20|0.37|0.8244
72598390|NCT04575584|144727888|SUPERIORITY||Odds Ratio (OR)|0.77||||0.5022|TWO_SIDED|95.0|0.36|1.64|||Wald Chi-Square||Based on the proportional odds model with WHO-11 score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|||1.64|0.36|0.5022
72598391|NCT04575584|144727888|SUPERIORITY||Odds Ratio (OR)|0.78||||0.5204|TWO_SIDED|95.0|0.37|1.64|||Wald Chi-Square||Based on the proportional odds model with WHO-11 score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|||1.64|0.37|0.5204
72598392|NCT04575584|144727888|SUPERIORITY||Odds Ratio (OR)|0.52||||0.0991|TWO_SIDED|95.0|0.24|1.13|||Wald Chi-Square||Based on the proportional odds model with WHO-11 score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|||1.13|0.24|0.0991
72598393|NCT04575584|144727889|SUPERIORITY||Odds Ratio (OR)|1.18||||0.6346|TWO_SIDED|95.0|0.6|2.29|||Wald Chi-Square||Based on the proportional odds model with WHO-11 score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|||2.29|0.60|0.6346
72598394|NCT04575584|144727889|SUPERIORITY||Odds Ratio (OR)|0.9||||0.7596|TWO_SIDED|95.0|0.46|1.75|||Wald Chi-Square||Based on the proportional odds model with WHO-11 score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|||1.75|0.46|0.7596
72598395|NCT04575584|144727889|SUPERIORITY||Odds Ratio (OR)|0.95||||0.8879|TWO_SIDED|95.0|0.49|1.84|||Wald Chi-Square||Based on the proportional odds model with WHO-11 score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|||1.84|0.49|0.8879
72598396|NCT04575584|144727890|SUPERIORITY||Odds Ratio (OR)|1.24||||0.6002|TWO_SIDED|95.0|0.55|2.82|||Wald Chi-Square||Based on the proportional odds model with WHO-11 score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|||2.82|0.55|0.6002
72598397|NCT04575584|144727890|SUPERIORITY||Odds Ratio (OR)|1.37||||0.4733|TWO_SIDED|95.0|0.58|3.21|||Wald Chi-Square||Based on the proportional odds model with WHO-11 score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|||3.21|0.58|0.4733
72415801|NCT01680328|144342428|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.6||||||95.0|1.4|4.8||||||Acceptance of pain was rated subjectively as yes or no by the subject after each injection. The odds are calculated as 'no versus yes', and 'larger volume versus smaller', so that an odds ratio above 1 corresponds to a higher frequency of unacceptable pain for the larger volume - i.e. a worse condition. The odd ratios for unacceptable injection pain are based on a statistical model for all acceptance pain data.||4.8|1.4|
72598398|NCT04575584|144727890|SUPERIORITY||Odds Ratio (OR)|0.82||||0.622|TWO_SIDED|95.0|0.38|1.78|||Wald Chi-Square||Based on the proportional odds model with WHO-11 score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|||1.78|0.38|0.6220
72415802|NCT01680328|144342428|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.6||||||95.0|1.4|4.6||||||Acceptance of pain was rated subjectively as yes or no by the subject after each injection. The odds are calculated as 'no versus yes', and 'larger volume versus smaller', so that an odds ratio above 1 corresponds to a higher frequency of unacceptable pain for the larger volume - i.e. a worse condition. The odd ratios for unacceptable injection pain are based on a statistical model for all acceptance pain data.||4.6|1.4|
72598399|NCT04575584|144727891|SUPERIORITY||Odds Ratio (OR)|0.86||||0.7871|TWO_SIDED|95.0|0.28|2.6|||Wald Chi-Square||Based on the proportional odds model with WHO-11 score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|||2.60|0.28|0.7871
72598400|NCT04575584|144727891|SUPERIORITY||Odds Ratio (OR)|0.97||||0.9598|TWO_SIDED|95.0|0.31|3.06|||Wald Chi-Square||Based on the proportional odds model with WHO-11 score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|||3.06|0.31|0.9598
72598401|NCT04575584|144727891|SUPERIORITY||Odds Ratio (OR)|0.79||||0.667|TWO_SIDED|95.0|0.27|2.31|||Wald Chi-Square||Based on the proportional odds model with WHO-11 score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|||2.31|0.27|0.6670
72598402|NCT02085070|144727904|SUPERIORITY|A response of \> 10% of patients was defined as superior.|% response|29.7|||||TWO_SIDED|95.0|15.9|47.0||||||Each group was assessed individually. The primary goal of this study is to determine the efficacy of MK-3475 in patients with untreated brain metastases from NSCLC. The primary endpoint is the brain metastasis response rate (BMRR). A drug with minimal activity would be expected to have a BMRR of 10%.||47.0|15.9|
72598403|NCT02085070|144727904|SUPERIORITY|A response of \> 10% of patients was defined as superior.|% of patients|26.0|||||TWO_SIDED|95.0|10.0|48.0||||||Each group was assessed individually. The primary goal of this study is to determine the efficacy of MK-3475 in patients with untreated brain metastases from melanoma. The primary endpoint is the brain metastasis response rate (BMRR). A drug with minimal activity would be expected to have a BMRR of 10%.||48.0|10.0|
72598404|NCT02769312|144727906|OTHER||Effect size (cohen's d)|0.16||||0.46|TWO_SIDED||||||ANCOVA|||||||0.46
72598405|NCT02769312|144727907|SUPERIORITY||Effect size (cohen's d)|0.12||||0.61|TWO_SIDED||||||ANCOVA|||||||0.61
72598406|NCT02769312|144727908|SUPERIORITY||Effect size (cohen's d)|0.39||||0.04|TWO_SIDED||||||ANCOVA|||||||.04
72598407|NCT03517449|144727941|SUPERIORITY||Hazard Ratio (HR)|0.56|||<|0.0001|TWO_SIDED|95.0|0.47|0.66|||Log Rank||Regression, Cox method|||0.66|0.47|<0.0001
72598408|NCT03517449|144727942|SUPERIORITY||Hazard Ratio (HR)|0.62|||<|0.0001|TWO_SIDED|95.0|0.51|0.75|||Log Rank||Regression, Cox method|||0.75|0.51|<0.0001
72598409|NCT03517449|144727943|SUPERIORITY||Difference in Percent|17.2|||<|0.0001|TWO_SIDED|95.0|11.5|22.9|||Miettinen & Nurminen method|||||22.9|11.5|<0.0001
72598410|NCT01096680|144727965|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|8.0|||<|0.0001|TWO_SIDED|95.0|5.0|10.9|||Mixed Models Analysis|||||10.9|5.0|<0.0001
72598411|NCT01096680|144727965|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|12.6|||<|0.0001|TWO_SIDED|95.0|10.2|15.0|||Mixed Models Analysis|||||15.0|10.2|<0.0001
72598412|NCT01096680|144727965|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|14.0|||<|0.0001|TWO_SIDED|95.0|11.7|16.2|||Mixed Models Analysis|||||16.2|11.7|<0.0001
72598413|NCT01096680|144727965|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|12.3|||<|0.0001|TWO_SIDED|95.0|9.9|14.7|||Mixed Models Analysis|||||14.7|9.9|<0.0001
72598414|NCT01096680|144727965|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.3||||0.0014|TWO_SIDED|95.0|-6.9|-1.8|||Mixed Models Analysis|||||-1.8|-6.9|0.0014
72598415|NCT01096680|144727965|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.3||||0.7601|TWO_SIDED|95.0|-1.5|2.1|||Mixed Models Analysis|||||2.1|-1.5|0.7601
72598416|NCT01096680|144727965|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.7||||0.0351|TWO_SIDED|95.0|0.1|3.2|||Mixed Models Analysis|||||3.2|0.1|0.0351
72598417|NCT01096680|144727966|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.5||||0.1123|TWO_SIDED|95.0|-1.1|0.1|||Mixed Models Analysis|||||0.1|-1.1|0.1123
72598418|NCT01096680|144727966|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.2||||0.0002|TWO_SIDED|95.0|-1.8|-0.6|||Mixed Models Analysis|||||-0.6|-1.8|0.0002
72598419|NCT01096680|144727966|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.6|||<|0.0001|TWO_SIDED|95.0|-2.2|-1.0|||Mixed Models Analysis|||||-1.0|-2.2|<0.0001
72598420|NCT01096680|144727966|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.5||||0.0947|TWO_SIDED|95.0|-1.1|0.1|||Mixed Models Analysis|||||0.1|-1.1|0.0947
72598421|NCT01096680|144727966|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0||||0.9393|TWO_SIDED|95.0|-0.6|0.6|||Mixed Models Analysis|||||0.6|-0.6|0.9393
72598422|NCT01096680|144727966|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.7||||0.0297|TWO_SIDED|95.0|-1.3|-0.1|||Mixed Models Analysis|||||-0.1|-1.3|0.0297
72598423|NCT01096680|144727966|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.1||||0.0004|TWO_SIDED|95.0|-1.7|-0.5|||Mixed Models Analysis|||||-0.5|-1.7|0.0004
72598424|NCT01096680|144727967|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.1||||0.7758|TWO_SIDED|95.0|-0.5|0.6|||Mixed Models Analysis|||7:50pm||0.6|-0.5|0.7758
72598425|NCT01096680|144727967|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.4||||0.1798|TWO_SIDED|95.0|-0.2|0.9|||Mixed Models Analysis|||7:50pm||0.9|-0.2|0.1798
72598426|NCT01096680|144727967|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.1||||0.609|TWO_SIDED|95.0|-0.4|0.7|||Mixed Models Analysis|||7:50pm||0.7|-0.4|0.6090
72598427|NCT01096680|144727967|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.4||||0.1169|TWO_SIDED|95.0|-0.1|1.0|||Mixed Models Analysis|||7:50pm||1.0|-0.1|0.1169
72598428|NCT01096680|144727967|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.3||||0.3028|TWO_SIDED|95.0|-0.8|0.3|||Mixed Models Analysis|||7:50pm||0.3|-0.8|0.3028
72598429|NCT01096680|144727967|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0||||0.9831|TWO_SIDED|95.0|-0.5|0.5|||Mixed Models Analysis|||7:50pm||0.5|-0.5|0.9831
72598430|NCT01096680|144727967|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.3||||0.2887|TWO_SIDED|95.0|-0.8|0.2|||Mixed Models Analysis|||7:50pm||0.2|-0.8|0.2887
72598431|NCT01096680|144727967|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.2||||0.4395|TWO_SIDED|95.0|-0.8|0.3|||Mixed Models Analysis|||8:50pm||0.3|-0.8|0.4395
72598432|NCT01096680|144727967|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0||||0.9019|TWO_SIDED|95.0|-0.5|0.6|||Mixed Models Analysis|||8:50pm||0.6|-0.5|0.9019
72598433|NCT01096680|144727967|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.3||||0.3419|TWO_SIDED|95.0|-0.8|0.3|||Mixed Models Analysis|||8:50pm||0.3|-0.8|0.3419
72598434|NCT01096680|144727967|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0||||0.9581|TWO_SIDED|95.0|-0.6|0.5|||Mixed Models Analysis|||8:50pm||0.5|-0.6|0.9581
72598435|NCT01096680|144727967|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.3||||0.2572|TWO_SIDED|95.0|-0.9|0.2|||Mixed Models Analysis|||8:50pm||0.2|-0.9|0.2572
72598436|NCT01096680|144727967|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.1||||0.8085|TWO_SIDED|95.0|-0.6|0.5|||Mixed Models Analysis|||8:50pm||0.5|-0.6|0.8085
72598437|NCT01096680|144727967|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.3||||0.3678|TWO_SIDED|95.0|-0.8|0.3|||Mixed Models Analysis|||8:50pm||0.3|-0.8|0.3678
72598438|NCT01096680|144727967|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.3||||0.3732|TWO_SIDED|95.0|-0.9|0.4|||Mixed Models Analysis|||9:50pm||0.4|-0.9|0.3732
72598439|NCT01096680|144727967|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.2||||0.4924|TWO_SIDED|95.0|-0.9|0.4|||Mixed Models Analysis|||9:50pm||0.4|-0.9|0.4924
72598440|NCT01096680|144727967|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0||||0.9798|TWO_SIDED|95.0|-0.7|0.6|||Mixed Models Analysis|||9:50pm||0.6|-0.7|0.9798
72598441|NCT01096680|144727967|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.1||||0.8557|TWO_SIDED|95.0|-0.6|0.7|||Mixed Models Analysis|||9:50pm||0.7|-0.6|0.8557
72598442|NCT01096680|144727967|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.5||||0.0998|TWO_SIDED|95.0|-1.2|0.1|||Mixed Models Analysis|||9:50pm||0.1|-1.2|0.0998
72598443|NCT01096680|144727967|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.5||||0.1479|TWO_SIDED|95.0|-1.1|0.2|||Mixed Models Analysis|||9:50pm||0.2|-1.1|0.1479
72598444|NCT01096680|144727967|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.1||||0.8358|TWO_SIDED|95.0|-0.7|0.6|||Mixed Models Analysis|||9:50pm||0.6|-0.7|0.8358
72598445|NCT01096680|144727967|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.9||||0.0199|TWO_SIDED|95.0|-1.6|-0.1|||Mixed Models Analysis|||10:50pm||-0.1|-1.6|0.0199
72598446|NCT01096680|144727967|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.1||||0.7625|TWO_SIDED|95.0|-0.9|0.6|||Mixed Models Analysis|||10:50pm||0.6|-0.9|0.7625
72598447|NCT01096680|144727967|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.5||||0.1936|TWO_SIDED|95.0|-1.2|0.3|||Mixed Models Analysis|||10:50pm||0.3|-1.2|0.1936
72598448|NCT01096680|144727967|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.3||||0.4534|TWO_SIDED|95.0|-0.5|1.0|||Mixed Models Analysis|||10:50pm||1.0|-0.5|0.4534
72598449|NCT01096680|144727967|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.2||||0.0012|TWO_SIDED|95.0|-2.0|-0.5|||Mixed Models Analysis|||10:50pm||-0.5|-2.0|0.0012
72598450|NCT01096680|144727967|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.5||||0.2072|TWO_SIDED|95.0|-1.2|0.3|||Mixed Models Analysis|||10:50pm||0.3|-1.2|0.2072
72598451|NCT01096680|144727967|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.8||||0.0413|TWO_SIDED|95.0|-1.5|0.0|||Mixed Models Analysis|||10:50pm||0.0|-1.5|0.0413
72598452|NCT01096680|144727967|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.7||||0.1086|TWO_SIDED|95.0|-1.5|0.1|||Mixed Models Analysis|||11:50pm||0.1|-1.5|0.1086
72598453|NCT01096680|144727967|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.2||||0.5843|TWO_SIDED|95.0|-1.0|0.6|||Mixed Models Analysis|||11:50pm||0.6|-1.0|0.5843
72598454|NCT01096680|144727967|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.8||||0.0571|TWO_SIDED|95.0|-1.6|0.0|||Mixed Models Analysis|||11:50pm||0.0|-1.6|0.0571
72598455|NCT01096680|144727967|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.3||||0.3965|TWO_SIDED|95.0|-1.2|0.5|||Mixed Models Analysis|||11:50pm||0.5|-1.2|0.3965
72598456|NCT01096680|144727967|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.4||||0.0009|TWO_SIDED|95.0|-2.2|-0.6|||Mixed Models Analysis|||11:50pm||-0.6|-2.2|0.0009
72598457|NCT01096680|144727967|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.0||||0.0211|TWO_SIDED|95.0|-1.8|-0.1|||Mixed Models Analysis|||11:50pm||-0.1|-1.8|0.0211
72598458|NCT01096680|144727967|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.4||||0.2863|TWO_SIDED|95.0|-1.2|0.4|||Mixed Models Analysis|||11:50pm||0.4|-1.2|0.2863
72598459|NCT01096680|144727967|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.8||||0.0428|TWO_SIDED|95.0|-1.7|0.0|||Mixed Models Analysis|||12:50am||0.0|-1.7|0.0428
72598460|NCT01096680|144727967|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.4||||0.3757|TWO_SIDED|95.0|-0.5|1.2|||Mixed Models Analysis|||12:50am||1.2|-0.5|0.3757
72598461|NCT01096680|144727967|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.6||||0.0002|TWO_SIDED|95.0|-2.4|-0.8|||Mixed Models Analysis|||12:50am||-0.8|-2.4|0.0002
72598462|NCT01096680|144727967|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.4||||0.3535|TWO_SIDED|95.0|-1.2|0.4|||Mixed Models Analysis|||12:50am||0.4|-1.2|0.3535
72598463|NCT01096680|144727967|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.9|||<|0.0001|TWO_SIDED|95.0|-2.7|-1.1|||Mixed Models Analysis|||12:50am||-1.1|-2.7|<0.0001
72598464|NCT01096680|144727967|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.7||||0.1131|TWO_SIDED|95.0|-1.5|0.2|||Mixed Models Analysis|||12:50am||0.2|-1.5|0.1131
72598465|NCT01096680|144727967|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.2||||0.0039|TWO_SIDED|95.0|-2.0|-0.4|||Mixed Models Analysis|||12:50am||-0.4|-2.0|0.0039
72598466|NCT01096680|144727967|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.7||||0.1302|TWO_SIDED|95.0|-1.5|0.2|||Mixed Models Analysis|||1:50am||0.2|-1.5|0.1302
72598467|NCT01096680|144727967|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.2||||0.6138|TWO_SIDED|95.0|-0.6|1.1|||Mixed Models Analysis|||1:50am||1.1|-0.6|0.6138
72598468|NCT01096680|144727967|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.5||||0.0008|TWO_SIDED|95.0|-2.3|-0.6|||Mixed Models Analysis|||1:50am||-0.6|-2.3|0.0008
72598469|NCT01096680|144727967|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.6||||0.1643|TWO_SIDED|95.0|-1.5|0.3|||Mixed Models Analysis|||1:50am||0.3|-1.5|0.1643
72598470|NCT01096680|144727967|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.7||||0.0002|TWO_SIDED|95.0|-2.5|-0.8|||Mixed Models Analysis|||1:50am||-0.8|-2.5|0.0002
72598471|NCT01096680|144727967|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.8||||0.0782|TWO_SIDED|95.0|-1.6|0.1|||Mixed Models Analysis|||1:50am||0.1|-1.6|0.0782
72598472|NCT01096680|144727967|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.9||||0.0441|TWO_SIDED|95.0|-1.7|0.0|||Mixed Models Analysis|||1:50am||0.0|-1.7|0.0441
72598473|NCT01096680|144727967|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.2||||0.0193|TWO_SIDED|95.0|-2.2|-0.2|||Mixed Models Analysis|||2:50am||-0.2|-2.2|0.0193
72598474|NCT01096680|144727967|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.2||||0.7071|TWO_SIDED|95.0|-1.2|0.8|||Mixed Models Analysis|||2:50am||0.8|-1.2|0.7071
72598475|NCT01096680|144727967|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.9||||0.0002|TWO_SIDED|95.0|-2.9|-0.9|||Mixed Models Analysis|||2:50am||-0.9|-2.9|0.0002
72598476|NCT01096680|144727967|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.9||||0.0611|TWO_SIDED|95.0|-1.9|0.0|||Mixed Models Analysis|||2:50am||0.0|-1.9|0.0611
72598477|NCT01096680|144727967|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.2|||<|0.0001|TWO_SIDED|95.0|-3.2|-1.2|||Mixed Models Analysis|||2:50am||-1.2|-3.2|<0.0001
72598478|NCT01096680|144727967|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.2||||0.016|TWO_SIDED|95.0|-2.2|-0.2|||Mixed Models Analysis|||2:50am||-0.2|-2.2|0.0160
72598479|NCT01096680|144727967|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.0||||0.048|TWO_SIDED|95.0|-2.0|0.0|||Mixed Models Analysis|||2:50am||0.0|-2.0|0.0480
72598480|NCT01096680|144727967|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.2||||0.0234|TWO_SIDED|95.0|-2.2|-0.2|||Mixed Models Analysis|||3:50am||-0.2|-2.2|0.0234
72598481|NCT01096680|144727967|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.3||||0.5624|TWO_SIDED|95.0|-1.3|0.7|||Mixed Models Analysis|||3:50am||0.7|-1.3|0.5624
72598482|NCT01096680|144727967|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.5|||<|0.0001|TWO_SIDED|95.0|-3.5|-1.5|||Mixed Models Analysis|||3:50am||-1.5|-3.5|<0.0001
72598483|NCT01096680|144727967|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.6||||0.0022|TWO_SIDED|95.0|-2.6|-0.6|||Mixed Models Analysis|||3:50am||-0.6|-2.6|0.0022
72598484|NCT01096680|144727967|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.7|||<|0.0001|TWO_SIDED|95.0|-3.7|-1.6|||Mixed Models Analysis|||3:50am||-1.6|-3.7|<0.0001
72598485|NCT01096680|144727967|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.8||||0.0008|TWO_SIDED|95.0|-2.8|-0.8|||Mixed Models Analysis|||3:50am||-0.8|-2.8|0.0008
72598486|NCT01096680|144727967|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.9||||0.0883|TWO_SIDED|95.0|-1.9|0.1|||Mixed Models Analysis|||3:50am||0.1|-1.9|0.0883
72598487|NCT01096680|144727967|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.5||||0.3093|TWO_SIDED|95.0|-1.5|0.5|||Mixed Models Analysis|||4:50am||0.5|-1.5|0.3093
72598488|NCT01096680|144727967|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.1||||0.8871|TWO_SIDED|95.0|-0.9|1.1|||Mixed Models Analysis|||4:50am||1.1|-0.9|0.8871
72598489|NCT01096680|144727967|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.2|||<|0.0001|TWO_SIDED|95.0|-3.2|-1.2|||Mixed Models Analysis|||4:50am||-1.2|-3.2|<0.0001
72598490|NCT01096680|144727967|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.6||||0.0022|TWO_SIDED|95.0|-2.6|-0.6|||Mixed Models Analysis|||4:50am||-0.6|-2.6|0.0022
72598491|NCT01096680|144727967|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.4|||<|0.0001|TWO_SIDED|95.0|-3.4|-1.4|||Mixed Models Analysis|||4:50am||-1.4|-3.4|<0.0001
72598492|NCT01096680|144727967|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.8||||0.0006|TWO_SIDED|95.0|-2.8|-0.8|||Mixed Models Analysis|||4:50am||-0.8|-2.8|0.0006
72598493|NCT01096680|144727967|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.6||||0.2462|TWO_SIDED|95.0|-1.6|0.4|||Mixed Models Analysis|||4:50am||0.4|-1.6|0.2462
72598494|NCT01096680|144727967|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.4||||0.4427|TWO_SIDED|95.0|-1.4|0.6|||Mixed Models Analysis|||5:50am||0.6|-1.4|0.4427
72598495|NCT01096680|144727967|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.4||||0.4405|TWO_SIDED|95.0|-0.6|1.4|||Mixed Models Analysis|||5:50am||1.4|-0.6|0.4405
72598496|NCT01096680|144727967|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.0||||0.0003|TWO_SIDED|95.0|-3.0|-0.9|||Mixed Models Analysis|||5:50am||-0.9|-3.0|0.0003
72598497|NCT01096680|144727967|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.2||||0.0279|TWO_SIDED|95.0|-2.2|-0.1|||Mixed Models Analysis|||5:50am||-0.1|-2.2|0.0279
72598498|NCT01096680|144727967|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.5|||<|0.0001|TWO_SIDED|95.0|-3.5|-1.5|||Mixed Models Analysis|||5:50am||-1.5|-3.5|<0.0001
72598499|NCT01096680|144727967|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.7||||0.0015|TWO_SIDED|95.0|-2.7|-0.7|||Mixed Models Analysis|||5:50am||-0.7|-2.7|0.0015
72598500|NCT01096680|144727967|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.8||||0.1246|TWO_SIDED|95.0|-1.8|0.2|||Mixed Models Analysis|||5:50am||0.2|-1.8|0.1246
72598501|NCT01096680|144727967|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.6||||0.3067|TWO_SIDED|95.0|-1.6|0.5|||Mixed Models Analysis|||6:50am||0.5|-1.6|0.3067
72598502|NCT01096680|144727967|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.1||||0.894|TWO_SIDED|95.0|-1.0|1.1|||Mixed Models Analysis|||6:50am||1.1|-1.0|0.8940
72598503|NCT01096680|144727967|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.6||||0.0034|TWO_SIDED|95.0|-2.7|-0.5|||Mixed Models Analysis|||6:50am||-0.5|-2.7|0.0034
72598504|NCT01096680|144727967|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.0||||0.0708|TWO_SIDED|95.0|-2.0|0.1|||Mixed Models Analysis|||6:50am||0.1|-2.0|0.0708
72598505|NCT01096680|144727967|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.5|||<|0.0001|TWO_SIDED|95.0|-3.6|-1.4|||Mixed Models Analysis|||6:50am||-1.4|-3.6|<0.0001
72598506|NCT01096680|144727967|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.9||||0.0006|TWO_SIDED|95.0|-2.9|-0.8|||Mixed Models Analysis|||6:50am||-0.8|-2.9|0.0006
72598507|NCT01096680|144727967|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.6||||0.2476|TWO_SIDED|95.0|-1.7|0.4|||Mixed Models Analysis|||6:50am||0.4|-1.7|0.2476
72598508|NCT01096680|144727967|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.7||||0.231|TWO_SIDED|95.0|-1.8|0.4|||Mixed Models Analysis|||7:50am||0.4|-1.8|0.2310
72598509|NCT01096680|144727967|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.1||||0.8369|TWO_SIDED|95.0|-1.2|1.0|||Mixed Models Analysis|||7:50am||1.0|-1.2|0.8369
72598510|NCT01096680|144727967|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.6||||0.0035|TWO_SIDED|95.0|-2.7|-0.5|||Mixed Models Analysis|||7:50am||-0.5|-2.7|0.0035
72598511|NCT01096680|144727967|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.1||||0.0498|TWO_SIDED|95.0|-2.2|0.0|||Mixed Models Analysis|||7:50am||0.0|-2.2|0.0498
72598512|NCT01096680|144727967|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.5|||<|0.0001|TWO_SIDED|95.0|-3.6|-1.4|||Mixed Models Analysis|||7:50am||-1.4|-3.6|<0.0001
72598513|NCT01096680|144727967|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.9||||0.0007|TWO_SIDED|95.0|-3.0|-0.8|||Mixed Models Analysis|||7:50am||-0.8|-3.0|0.0007
72415803|NCT01680328|144342428|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.0||||||95.0|0.7|1.5||||||Acceptance of pain was rated subjectively as yes or no by the subject after each injection. The odds are calculated as 'no versus yes', and 'larger volume versus smaller', so that an odds ratio above 1 corresponds to a higher frequency of unacceptable pain for the larger volume - i.e. a worse condition. The odd ratios for unacceptable injection pain are based on a statistical model for all acceptance pain data.||1.5|0.7|
72415804|NCT01680328|144342429|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.1||||||95.0|0.7|1.8||||||Acceptance of pain was rated subjectively as yes or no by the subject after each injection. The odds are calculated as 'no versus yes', and 'higher speed versus lower', so that an odds ratio above 1 corresponds to a higher frequency of unacceptable pain for the higher speed - i.e. a worse condition. The odd ratios for unacceptable injection pain are based on a statistical model for all acceptance pain data.||1.8|0.7|
72415805|NCT01680328|144342429|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.9||||||95.0|0.6|1.2||||||Acceptance of pain was rated subjectively as yes or no by the subject after each injection. The odds are calculated as 'no versus yes', and 'higher speed versus lower', so that an odds ratio above 1 corresponds to a higher frequency of unacceptable pain for the higher speed - i.e. a worse condition. The odd ratios for unacceptable injection pain are based on a statistical model for all acceptance pain data.||1.2|0.6|
72415806|NCT01680328|144342430|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.7||||||95.0|2.4|5.5|||Odds ratio (OR)|||Acceptance of pain was rated subjectively as yes or no by the subject after each injection. The odds are calculated as 'no versus yes', so that an odds ratio above 1 corresponds to a higher frequency of unacceptable pain in the thighs - i.e. a worse condition.||5.5|2.4|
72598514|NCT01096680|144727967|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.5||||0.3198|TWO_SIDED|95.0|-1.6|0.5|||Mixed Models Analysis|||7:50am||0.5|-1.6|0.3198
72598515|NCT01096680|144727967|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.5||||0.375|TWO_SIDED|95.0|-0.6|1.7|||Mixed Models Analysis|||8:50am||1.7|-0.6|0.3750
72598516|NCT01096680|144727967|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.2||||0.7978|TWO_SIDED|95.0|-1.3|1.0|||Mixed Models Analysis|||8:50am||1.0|-1.3|0.7978
72598517|NCT01096680|144727967|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.4||||0.5197|TWO_SIDED|95.0|-1.5|0.8|||Mixed Models Analysis|||8:50am||0.8|-1.5|0.5197
72598518|NCT01096680|144727967|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.1||||0.0751|TWO_SIDED|95.0|-2.2|0.1|||Mixed Models Analysis|||8:50am||0.1|-2.2|0.0751
72598519|NCT01096680|144727967|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.0||||0.1079|TWO_SIDED|95.0|-2.1|0.2|||Mixed Models Analysis|||8:50am||0.2|-2.1|0.1079
72598520|NCT01096680|144727967|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.6||||0.0065|TWO_SIDED|95.0|-2.8|-0.5|||Mixed Models Analysis|||8:50am||-0.5|-2.8|0.0065
72598521|NCT01096680|144727967|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.7||||0.2529|TWO_SIDED|95.0|-0.5|1.8|||Mixed Models Analysis|||8:50am||1.8|-0.5|0.2529
72598522|NCT01096680|144727967|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.3||||0.6364|TWO_SIDED|95.0|-1.3|0.8|||Mixed Models Analysis|||9:50am||0.8|-1.3|0.6364
72598523|NCT01096680|144727967|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0||||0.9417|TWO_SIDED|95.0|-1.1|1.0|||Mixed Models Analysis|||9:50am||1.0|-1.1|0.9417
72598524|NCT01096680|144727967|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.3||||0.02|TWO_SIDED|95.0|-2.3|-0.2|||Mixed Models Analysis|||9:50am||-0.2|-2.3|0.0200
72598525|NCT01096680|144727967|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.1||||0.0527|TWO_SIDED|95.0|-2.1|0.0|||Mixed Models Analysis|||9:50am||0.0|-2.1|0.0527
72598526|NCT01096680|144727967|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.4||||0.0107|TWO_SIDED|95.0|-2.5|-0.3|||Mixed Models Analysis|||9:50am||-0.3|-2.5|0.0107
72598527|NCT01096680|144727967|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.2||||0.0303|TWO_SIDED|95.0|-2.2|-0.1|||Mixed Models Analysis|||9:50am||-0.1|-2.2|0.0303
72598528|NCT01096680|144727967|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.2||||0.6889|TWO_SIDED|95.0|-1.3|0.8|||Mixed Models Analysis|||9:50am||0.8|-1.3|0.6889
72598529|NCT01096680|144727967|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0||||0.9552|TWO_SIDED|95.0|-1.2|1.1|||Mixed Models Analysis|||10:50am||1.1|-1.2|0.9552
72598530|NCT01096680|144727967|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.2||||0.7558|TWO_SIDED|95.0|-1.0|1.3|||Mixed Models Analysis|||10:50am||1.3|-1.0|0.7558
72598531|NCT01096680|144727967|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.8||||0.1824|TWO_SIDED|95.0|-1.9|0.4|||Mixed Models Analysis|||10:50am||0.4|-1.9|0.1824
72598532|NCT01096680|144727967|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.6||||0.3323|TWO_SIDED|95.0|-1.7|0.6|||Mixed Models Analysis|||10:50am||0.6|-1.7|0.3323
72598533|NCT01096680|144727967|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.2||||0.0413|TWO_SIDED|95.0|-2.4|0.0|||Mixed Models Analysis|||10:50am||0.0|-2.4|0.0413
72598534|NCT01096680|144727967|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.0||||0.0925|TWO_SIDED|95.0|-2.2|0.2|||Mixed Models Analysis|||10:50am||0.2|-2.2|0.0925
72598535|NCT01096680|144727967|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.2||||0.7133|TWO_SIDED|95.0|-1.4|0.9|||Mixed Models Analysis|||10:50am||0.9|-1.4|0.7133
72598536|NCT01096680|144727968|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-26.5|||<|0.0001|TWO_SIDED|95.0|-36.6|-16.5|||Mixed Models Analysis|||||-16.5|-36.6|<0.0001
72598537|NCT01096680|144727968|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-35.4|||<|0.0001|TWO_SIDED|95.0|-45.5|-25.4|||Mixed Models Analysis|||||-25.4|-45.5|<0.0001
72415807|NCT01680328|144342431|SUPERIORITY_OR_OTHER||Least Square Mean Difference|0.6||||||95.0|-0.6|1.8||||||Backflow (absorbed amount of liquid 2 minutes (±30 sec) after the injection with filter-paper rated according to the liquid scale) was analysed using a mixed ANOVA approach and calculated as the mean differences in backflow in the abdomen at different volume and speed combinations.||1.8|-0.6|
72415808|NCT01680328|144342431|SUPERIORITY_OR_OTHER||Least Square Mean Difference|0.4||||||95.0|-0.8|1.6||||||Backflow (absorbed amount of liquid 2 minutes (±30 sec) after the injection with filter-paper rated according to the liquid scale) was analysed using a mixed ANOVA approach and calculated as the mean differences in backflow in the abdomen at different volume and speed combinations.||1.6|-0.8|
72415809|NCT01680328|144342431|SUPERIORITY_OR_OTHER||Least Square Mean Difference|0.9||||||95.0|-0.4|2.1||||||Backflow (absorbed amount of liquid 2 minutes (±30 sec) after the injection with filter-paper rated according to the liquid scale) was analysed using a mixed ANOVA approach and calculated as the mean differences in backflow in the abdomen at different volume and speed combinations.||2.1|-0.4|
72598538|NCT01096680|144727968|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-26.7|||<|0.0001|TWO_SIDED|95.0|-36.7|-16.6|||Mixed Models Analysis|||||-16.6|-36.7|<0.0001
72598539|NCT01096680|144727968|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-26.5|||<|0.0001|TWO_SIDED|95.0|-36.6|-16.5|||Mixed Models Analysis|||||-16.5|-36.6|<0.0001
72598540|NCT01096680|144727968|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0||||0.9945|TWO_SIDED|95.0|-10.1|10.0|||Mixed Models Analysis|||||10.0|-10.1|0.9945
72598541|NCT01096680|144727968|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-8.9||||0.0814|TWO_SIDED|95.0|-18.9|1.1|||Mixed Models Analysis|||||1.1|-18.9|0.0814
72598542|NCT01096680|144727968|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.2||||0.9743|TWO_SIDED|95.0|-10.2|9.9|||Mixed Models Analysis|||||9.9|-10.2|0.9743
72598543|NCT01096680|144727969|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-9.6||||0.0544|TWO_SIDED|95.0|-19.4|0.2|||Mixed Models Analysis|||9:15pm||0.2|-19.4|0.0544
72598544|NCT01096680|144727969|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.8||||0.441|TWO_SIDED|95.0|-13.6|6.0|||Mixed Models Analysis|||9:15pm||6.0|-13.6|0.4410
72598545|NCT01096680|144727969|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-8.1||||0.1046|TWO_SIDED|95.0|-17.9|1.7|||Mixed Models Analysis|||9:15pm||1.7|-17.9|0.1046
72598546|NCT01096680|144727969|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.3||||0.6467|TWO_SIDED|95.0|-12.0|7.5|||Mixed Models Analysis|||9:15pm||7.5|-12.0|0.6467
72598547|NCT01096680|144727969|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.4||||0.1971|TWO_SIDED|95.0|-16.2|3.4|||Mixed Models Analysis|||9:15pm||3.4|-16.2|0.1971
72415810|NCT01680328|144342431|SUPERIORITY_OR_OTHER||Least Square Mean Difference|0.5||||||95.0|-0.8|1.7||||||Backflow (absorbed amount of liquid 2 minutes (±30 sec) after the injection with filter-paper rated according to the liquid scale) was analysed using a mixed ANOVA approach and calculated as the mean differences in backflow in the abdomen at different volume and speed combinations.||1.7|-0.8|
72598548|NCT01096680|144727969|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.6||||0.9052|TWO_SIDED|95.0|-10.4|9.2|||Mixed Models Analysis|||9:15pm||9.2|-10.4|0.9052
72598549|NCT01096680|144727969|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.8||||0.242|TWO_SIDED|95.0|-15.6|4.0|||Mixed Models Analysis|||9:15pm||4.0|-15.6|0.2420
72598550|NCT01096680|144727969|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-16.7||||0.0001|TWO_SIDED|95.0|-25.1|-8.3|||Mixed Models Analysis|||11:15pm||-8.3|-25.1|0.0001
72598551|NCT01096680|144727969|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.3||||0.4321|TWO_SIDED|95.0|-5.0|11.6|||Mixed Models Analysis|||11:15pm||11.6|-5.0|0.4321
72598552|NCT01096680|144727969|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-18.4|||<|0.0001|TWO_SIDED|95.0|-26.7|-10.1|||Mixed Models Analysis|||11:15pm||-10.1|-26.7|<0.0001
72598553|NCT01096680|144727969|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.6||||0.6999|TWO_SIDED|95.0|-6.7|9.9|||Mixed Models Analysis|||11:15pm||9.9|-6.7|0.6999
72598554|NCT01096680|144727969|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-18.1|||<|0.0001|TWO_SIDED|95.0|-26.4|-9.8|||Mixed Models Analysis|||11:15pm||-9.8|-26.4|<0.0001
72598555|NCT01096680|144727969|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.9||||0.6566|TWO_SIDED|95.0|-6.4|10.2|||Mixed Models Analysis|||11:15pm||10.2|-6.4|0.6566
72598556|NCT01096680|144727969|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-20.0|||<|0.0001|TWO_SIDED|95.0|-28.3|-11.7|||Mixed Models Analysis|||11:15pm||-11.7|-28.3|<0.0001
72598557|NCT01096680|144727969|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-25.2|||<|0.0001|TWO_SIDED|95.0|-36.1|-14.3|||Mixed Models Analysis|||1:15am||-14.3|-36.1|<0.0001
72598558|NCT01096680|144727969|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.5||||0.7824|TWO_SIDED|95.0|-12.4|9.4|||Mixed Models Analysis|||1:15am||9.4|-12.4|0.7824
72598559|NCT01096680|144727969|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-25.1|||<|0.0001|TWO_SIDED|95.0|-36.0|-14.3|||Mixed Models Analysis|||1:15am||-14.3|-36.0|<0.0001
72598560|NCT01096680|144727969|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.5||||0.7867|TWO_SIDED|95.0|-12.4|9.4|||Mixed Models Analysis|||1:15am||9.4|-12.4|0.7867
72598561|NCT01096680|144727969|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-26.5|||<|0.0001|TWO_SIDED|95.0|-37.4|-15.6|||Mixed Models Analysis|||1:15am||-15.6|-37.4|<0.0001
72598562|NCT01096680|144727969|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.9||||0.6029|TWO_SIDED|95.0|-13.7|8.0|||Mixed Models Analysis|||1:15am||8.0|-13.7|0.6029
72598563|NCT01096680|144727969|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-23.6|||<|0.0001|TWO_SIDED|95.0|-34.5|-12.8|||Mixed Models Analysis|||1:15am||-12.8|-34.5|<0.0001
72598564|NCT01096680|144727969|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-37.1|||<|0.0001|TWO_SIDED|95.0|-50.1|-24.1|||Mixed Models Analysis|||3:15am||-24.1|-50.1|<0.0001
72598565|NCT01096680|144727969|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.1||||0.8684|TWO_SIDED|95.0|-11.9|14.1|||Mixed Models Analysis|||3:15am||14.1|-11.9|0.8684
72598566|NCT01096680|144727969|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-53.3|||<|0.0001|TWO_SIDED|95.0|-66.3|-40.3|||Mixed Models Analysis|||3:15am||-40.3|-66.3|<0.0001
72598567|NCT01096680|144727969|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-15.1||||0.0228|TWO_SIDED|95.0|-28.1|-2.1|||Mixed Models Analysis|||3:15am||-2.1|-28.1|0.0228
72598568|NCT01096680|144727969|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-40.0|||<|0.0001|TWO_SIDED|95.0|-53.0|-27.0|||Mixed Models Analysis|||3:15am||-27.0|-53.0|<0.0001
72598569|NCT01096680|144727969|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.8||||0.7852|TWO_SIDED|95.0|-14.8|11.2|||Mixed Models Analysis|||3:15am||11.2|-14.8|0.7852
72598570|NCT01096680|144727969|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-38.2|||<|0.0001|TWO_SIDED|95.0|-51.2|-25.2|||Mixed Models Analysis|||3:15am||-25.2|-51.2|<0.0001
72598571|NCT01096680|144727969|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-38.2|||<|0.0001|TWO_SIDED|95.0|-51.3|-25.1|||Mixed Models Analysis|||5:15am||-25.1|-51.3|<0.0001
72598572|NCT01096680|144727969|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.9||||0.5528|TWO_SIDED|95.0|-9.1|17.0|||Mixed Models Analysis|||5:15am||17.0|-9.1|0.5528
72598573|NCT01096680|144727969|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-53.9|||<|0.0001|TWO_SIDED|95.0|-67.0|-40.9|||Mixed Models Analysis|||5:15am||-40.9|-67.0|<0.0001
72598574|NCT01096680|144727969|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-11.8||||0.0747|TWO_SIDED|95.0|-24.9|1.2|||Mixed Models Analysis|||5:15am||1.2|-24.9|0.0747
72598575|NCT01096680|144727969|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-49.2|||<|0.0001|TWO_SIDED|95.0|-62.2|-36.1|||Mixed Models Analysis|||5:15am||-36.1|-62.2|<0.0001
72598576|NCT01096680|144727969|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-7.1||||0.2868|TWO_SIDED|95.0|-20.1|6.0|||Mixed Models Analysis|||5:15am||6.0|-20.1|0.2868
72598577|NCT01096680|144727969|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-42.1|||<|0.0001|TWO_SIDED|95.0|-55.2|-29.1|||Mixed Models Analysis|||5:15am||-29.1|-55.2|<0.0001
72598578|NCT01096680|144727969|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-37.6||||0.0007|TWO_SIDED|95.0|-59.1|-16.2|||Mixed Models Analysis|||7:15am||-16.2|-59.1|0.0007
72598579|NCT01096680|144727969|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.2||||0.9089|TWO_SIDED|95.0|-22.7|20.2|||Mixed Models Analysis|||7:15am||20.2|-22.7|0.9089
72598580|NCT01096680|144727969|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-52.9|||<|0.0001|TWO_SIDED|95.0|-74.3|-31.4|||Mixed Models Analysis|||7:15am||-31.4|-74.3|<0.0001
72598581|NCT01096680|144727969|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-16.5||||0.1307|TWO_SIDED|95.0|-37.9|5.0|||Mixed Models Analysis|||7:15am||5.0|-37.9|0.1307
72598582|NCT01096680|144727969|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-36.3||||0.0011|TWO_SIDED|95.0|-57.7|-14.8|||Mixed Models Analysis|||7:15am||-14.8|-57.7|0.0011
72598583|NCT01096680|144727969|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.1||||0.9903|TWO_SIDED|95.0|-21.3|21.6|||Mixed Models Analysis|||7:15am||21.6|-21.3|0.9903
72598584|NCT01096680|144727969|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-36.4||||0.001|TWO_SIDED|95.0|-57.8|-14.9|||Mixed Models Analysis|||7:15am||-14.9|-57.8|0.0010
72598585|NCT01096680|144727969|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-21.4||||0.1655|TWO_SIDED|95.0|-51.7|9.0|||Mixed Models Analysis|||9:15am||9.0|-51.7|0.1655
72598586|NCT01096680|144727969|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.0||||0.8975|TWO_SIDED|95.0|-32.4|28.5|||Mixed Models Analysis|||9:15am||28.5|-32.4|0.8975
72598587|NCT01096680|144727969|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-36.2||||0.0199|TWO_SIDED|95.0|-66.5|-5.8|||Mixed Models Analysis|||9:15am||-5.8|-66.5|0.0199
72415811|NCT01680328|144342431|SUPERIORITY_OR_OTHER||Least Square Mean Difference|0.5||||||95.0|-0.8|1.7||||||Backflow (absorbed amount of liquid 2 minutes (±30 sec) after the injection with filter-paper rated according to the liquid scale) was analysed using a mixed ANOVA approach and calculated as the mean differences in backflow in the abdomen at different volume and speed combinations.||1.7|-0.8|
72598588|NCT01096680|144727969|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-16.8||||0.2785|TWO_SIDED|95.0|-47.2|13.7|||Mixed Models Analysis|||9:15am||13.7|-47.2|0.2785
72598589|NCT01096680|144727969|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-10.3||||0.5048|TWO_SIDED|95.0|-40.6|20.1|||Mixed Models Analysis|||9:15am||20.1|-40.6|0.5048
72598590|NCT01096680|144727969|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|9.1||||0.5533|TWO_SIDED|95.0|-21.3|39.6|||Mixed Models Analysis|||9:15am||39.6|-21.3|0.5533
72598591|NCT01096680|144727969|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-19.4||||0.2098|TWO_SIDED|95.0|-49.9|11.1|||Mixed Models Analysis|||9:15am||11.1|-49.9|0.2098
72598592|NCT02033200|144727974|SUPERIORITY_OR_OTHER||LS mean difference|0.076|STANDARD_ERROR_OF_MEAN|0.335||0.8216|TWO_SIDED|95.0|-0.592|0.744|||ANCOVA|||The sample size had enough power to detect any meaningful difference between treatment groups in the right eye.||0.744|-0.592|0.8216
72598593|NCT02033200|144727974|SUPERIORITY_OR_OTHER||LS means difference|0.257|STANDARD_ERROR_OF_MEAN|0.258||0.324|TWO_SIDED|95.0|-0.258|0.771|||ANCOVA|||The sample size had adequate power to detect a meaningful difference between treatment groups in the left eye.||0.771|-0.258|0.324
72598594|NCT02033200|144727975|SUPERIORITY_OR_OTHER||LS means difference|0.004|STANDARD_ERROR_OF_MEAN|0.014||0.7864|TWO_SIDED|95.0|-0.024|0.031|||ANCOVA|||The sample size provided enough power to detect any meaningful difference between the two treatment groups in the right eye.||0.031|-0.024|0.7864
72598595|NCT02033200|144727975|SUPERIORITY_OR_OTHER||LS Means difference|-0.022|STANDARD_ERROR_OF_MEAN|0.017||0.1953|TWO_SIDED|95.0|-0.056|0.012|||ANCOVA|||The sample size provided enough power to detect any meaningful difference between the two treatment groups in the left eye.||0.012|-0.056|0.1953
72598596|NCT02033200|144727976|SUPERIORITY_OR_OTHER||LS means difference|-0.16|STANDARD_ERROR_OF_MEAN|0.061||0.0101|TWO_SIDED|95.0|-0.28|-0.039|||ANCOVA|||The sample size provided enough power to detect any meaningful difference between the two treatment groups in the right eye.||-0.039|-0.280|0.0101
72598597|NCT02033200|144727976|SUPERIORITY_OR_OTHER||LS means difference|-0.087|STANDARD_ERROR_OF_MEAN|0.061||0.1583|TWO_SIDED|95.0|-0.209|0.035|||ANCOVA|||The sample size provided enough power to detect any meaningful difference between the two treatment groups in the left eye.||0.035|-0.209|0.1583
72598598|NCT02033200|144727977|SUPERIORITY_OR_OTHER||LS means difference|-0.031|STANDARD_ERROR_OF_MEAN|0.359||0.9324|TWO_SIDED|95.0|-0.746|0.685|||ANCOVA|||The sample size should provide approximately 90% power to detect a 1.6 mmHg difference in the mean change in Intraocular Pressure between the two treatment groups in the right eye.||0.685|-0.746|0.9324
72598599|NCT02033200|144727977|SUPERIORITY_OR_OTHER||LS means difference|0.751|STANDARD_ERROR_OF_MEAN|0.348||0.0343|TWO_SIDED|95.0|0.057|1.44|||ANCOVA|||The sample size should provide approximately 90% power to detect a 1.6 mmHg difference in the mean change in intraocular pressure between the two treatment groups in the left eye.||1.44|0.057|0.0343
72598600|NCT02033200|144727978|SUPERIORITY_OR_OTHER||LS Means difference|0.017|STANDARD_ERROR_OF_MEAN|0.017||0.3139|TWO_SIDED|95.0|-0.017|0.051|||ANCOVA|||The sample size had enough power to detect any meaningful difference between treatment groups in the right eye.||0.051|-0.017|0.3139
72598601|NCT02033200|144727978|SUPERIORITY_OR_OTHER||LS means difference|-0.002|STANDARD_ERROR_OF_MEAN|0.022||0.9334|TWO_SIDED|95.0|-0.045|0.042|||ANCOVA|||The sample size had enough power to detect any meaningful difference between treatment groups in the left eye.||0.042|-0.045|0.9334
72598602|NCT02033200|144727979|SUPERIORITY_OR_OTHER||LS means difference|0.016|STANDARD_ERROR_OF_MEAN|0.055||0.7723|TWO_SIDED|95.0|-0.093|0.125|||ANCOVA|||The sample size had enough power to detect any meaningful difference between treatment groups in the right eye.||0.125|-0.093|0.7723
72598603|NCT02033200|144727979|SUPERIORITY_OR_OTHER||LS means difference|0.007|STANDARD_ERROR_OF_MEAN|0.058||0.9107|TWO_SIDED|95.0|-0.109|0.122|||ANCOVA|||The sample size had enough power to detect any meaningful difference between treatment groups in the left eye.||0.122|-0.109|0.9107
72598604|NCT02033200|144727980|SUPERIORITY_OR_OTHER||LS Means difference|-0.078|STANDARD_ERROR_OF_MEAN|0.278||0.7787|TWO_SIDED|95.0|-0.632|0.475|||ANCOVA|||The sample size had enough power to detect any meaningful difference between treatment groups in the right eye.||0.475|-0.632|0.7787
72598605|NCT02033200|144727980|SUPERIORITY_OR_OTHER||LS means difference|-0.18|STANDARD_ERROR_OF_MEAN|0.344||0.6013|TWO_SIDED|95.0|-0.865|0.504|||ANCOVA|||The sample size had enough power to detect any meaningful difference between treatment groups in the left eye.||0.504|-0.865|0.6013
72598606|NCT02033200|144727981|SUPERIORITY_OR_OTHER||LS means difference|0.091|STANDARD_ERROR_OF_MEAN|0.4||0.8209|TWO_SIDED|95.0|-0.705|0.887|||ANCOVA|||The sample size should provide approximately 90% power to detect a 1.6 mmHg difference in the mean change in IOP between the two treatment groups in the right eye.||0.887|-0.705|0.8209
72598607|NCT02033200|144727981|SUPERIORITY_OR_OTHER||LS means difference|0.227|STANDARD_ERROR_OF_MEAN|0.33||0.4931|TWO_SIDED|95.0|-0.43|0.884|||ANCOVA|||The sample size should provide approximately 90% power to detect a 1.6 mmHg difference in the mean change in IOP between the two treatment groups in the left eye.||0.884|-0.430|0.4931
72598608|NCT00808470|144727995|SUPERIORITY_OR_OTHER|||||||0.58|||||||t-test, 2 sided|||15 minutes after exposure||||0.58
72598609|NCT00808470|144727995|SUPERIORITY_OR_OTHER|||||||0.39|||||||t-test, 2 sided|||1 hour and 15 minutes after exposure||||0.39
72598610|NCT00808470|144727995|SUPERIORITY_OR_OTHER|||||||0.51|||||||t-test, 2 sided|||2 Hours 15 minutes after exposure||||.51
72598611|NCT00808470|144727995|SUPERIORITY_OR_OTHER|||||||0.36|||||||t-test, 2 sided|||3 hours, 15 minutes after exposure||||.36
72598612|NCT00808470|144727995|SUPERIORITY_OR_OTHER|||||||0.86|||||||t-test, 2 sided|||1 day after exposure||||.86
72598613|NCT00808470|144727995|SUPERIORITY_OR_OTHER|||||||0.24|||||||t-test, 2 sided|||1 week after exposure||||.24
72598614|NCT01156051|144728025|SUPERIORITY_OR_OTHER|||||||0.005|||||||ANOVA|||Null hypothesis: no difference in total sleep time (TST) from baseline to termination. ANOVA single measure, two-tailed, Type II analysis was completed using SPSS.||||0.005
72598615|NCT01156051|144728026|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA|||Null hypothesis: no difference in ADHD Rating Scales - IV total scores from baseline to termination. ANOVA single measure, two-tailed, Type II analysis was completed using SPSS.||||<0.001
72598616|NCT01156051|144728027|SUPERIORITY_OR_OTHER|||||||0.392|||||||ANOVA|||Null hypothesis: no difference in latency to persistent sleep (LPS) from baseline to termination. ANOVA single measure, two-tailed, Type II analysis was completed using SPSS.||||0.392
72598617|NCT01156051|144728028|SUPERIORITY_OR_OTHER|||||||0.059|||||||ANOVA|||Null hypothesis: no difference in total sleep time (TST) from baseline to termination. ANOVA single measure, two-tailed, Type II analysis was completed using SPSS.||||0.059
72598618|NCT02620384|144728040|SUPERIORITY||Mean Difference (Final Values)|2439.511|STANDARD_ERROR_OF_MEAN|646.2707|<|0.0001|TWO_SIDED|95.0|1160.8485|3718.1734|||t-test, 2 sided|||||3718.1734|1160.8485|<0.0001
72598619|NCT02620384|144728041|SUPERIORITY||Mean Difference (Final Values)|-2249.3294|STANDARD_ERROR_OF_MEAN|608.2782|<|0.0001|TWO_SIDED|95.0|-3454.4999|-1044.1589|||t-test, 2 sided|||||-1044.1589|-3454.4999|<0.0001
72598620|NCT02620384|144728042|SUPERIORITY||Mean Difference (Final Values)|-2.717121|STANDARD_ERROR_OF_MEAN|0.586647|<|0.0001|TWO_SIDED|95.0|-3.8637732|-1.54651|||t-test, 2 sided|||||-1.546510|-3.8637732|<0.0001
72598621|NCT02620384|144728043|SUPERIORITY||Mean Difference (Final Values)|-0.6955|STANDARD_ERROR_OF_MEAN|0.2806||0.014|TWO_SIDED|95.0|-1.2506|-0.1403||Represents BORG\_48\_hours|t-test, 2 sided||Method of estimation is for 48 hour measure.|||-.1403|-1.2506|.014
72598622|NCT02620384|144728044|SUPERIORITY||Mean Difference (Final Values)|3.6903|STANDARD_ERROR_OF_MEAN|72.4074||0.959|TWO_SIDED|95.0|-1395694.0|147.1545|||t-test, 2 sided|||||147.1545|-1395694|.959
72598623|NCT02620384|144728045|SUPERIORITY|||||||0.144|||||||Chi-squared|||||||.144
72598624|NCT02620384|144728046|SUPERIORITY|||||||0.171|||||||Chi-squared|||||||.171
72598625|NCT02620384|144728047|SUPERIORITY||Mean Difference (Final Values)|0.106|STANDARD_ERROR_OF_MEAN|0.734||0.885|TWO_SIDED|95.0|-1.346|1.558|||t-test, 2 sided|||||1.558|-1.346|.885
72598626|NCT02620384|144728048|SUPERIORITY|||||||0.804|||||||Chi-squared|||||||.804
72598627|NCT02620384|144728049|SUPERIORITY|||||||0.403|||||||Chi-squared|||||||.403
72598628|NCT02620384|144728050|SUPERIORITY|||||||0.08|||||||Chi-squared|||||||.080
72598629|NCT02620384|144728051|SUPERIORITY|||||||0.559|||||||Chi-squared|||||||.559
72598630|NCT02494401|144728052|SUPERIORITY|||||||0.87||||||p value of baseline comparison.|Wilcoxon (Mann-Whitney)|||||||0.87
72598631|NCT02494401|144728052|SUPERIORITY|||||||0.32||||||p value for 16 week comparison|Wilcoxon (Mann-Whitney)|||||||0.32
72598632|NCT02494401|144728052|SUPERIORITY|||||||0.3||||||p value for 6 month comparison|Wilcoxon (Mann-Whitney)|||||||0.3
72598633|NCT02494401|144728053|SUPERIORITY|||||||0.08||||||p value of baseline comparison|Wilcoxon (Mann-Whitney)|||||||0.08
72598634|NCT02494401|144728053|SUPERIORITY|||||||0.05||||||p value 16 week comparison|Wilcoxon (Mann-Whitney)|||||||0.05
72598635|NCT02494401|144728053|SUPERIORITY|||||||0.008||||||p value 6 month comparison|Wilcoxon (Mann-Whitney)|||||||0.008
72598636|NCT02494401|144728054|SUPERIORITY|||||||0.68||||||p value baseline comparison|Wilcoxon (Mann-Whitney)|||||||0.68
72598637|NCT02494401|144728054|SUPERIORITY|||||||0.83||||||p value of 16 week comparison|Wilcoxon (Mann-Whitney)|||||||0.83
72598638|NCT02494401|144728054|SUPERIORITY|||||||0.23|||||||Wilcoxon (Mann-Whitney)|||||||0.23
72598639|NCT02494401|144728055|SUPERIORITY|||||||0.96||||||p value of baseline comparison|Wilcoxon (Mann-Whitney)|||||||0.96
72598640|NCT02494401|144728055|SUPERIORITY|||||||0.69||||||p value of 16 week comparison|Wilcoxon (Mann-Whitney)|||||||0.69
72598641|NCT02494401|144728055|SUPERIORITY|||||||0.6||||||p value of 6 month comparison|Wilcoxon (Mann-Whitney)|||||||0.6
72598642|NCT02494401|144728056|SUPERIORITY|||||||0.89||||||p value baseline comparison|Wilcoxon (Mann-Whitney)|||||||0.89
72598643|NCT02494401|144728056|SUPERIORITY|||||||0.32|||||||Wilcoxon (Mann-Whitney)|||||||0.32
72598644|NCT02494401|144728056|SUPERIORITY|||||||0.56||||||p value for 6 month comparison|Wilcoxon (Mann-Whitney)|||||||0.56
72598645|NCT02494401|144728057|SUPERIORITY|||||||0.69||||||p value for baseline comparison|Wilcoxon (Mann-Whitney)|||||||0.69
72598646|NCT02494401|144728057|SUPERIORITY|||||||0.29||||||p value for 16 week comparison|Wilcoxon (Mann-Whitney)|||||||0.29
72598647|NCT02494401|144728057|SUPERIORITY|||||||0.07||||||p value for 6 month comparison|Wilcoxon (Mann-Whitney)|||||||0.07
72598648|NCT02494401|144728058|SUPERIORITY|||||||0.28||||||p value for baseline comparison|Wilcoxon (Mann-Whitney)|||||||0.28
72598649|NCT02494401|144728058|SUPERIORITY|||||||0.16||||||p value for 16 week comparison|Wilcoxon (Mann-Whitney)|||||||0.16
72598650|NCT02494401|144728058|SUPERIORITY|||||||0.23||||||p value for 6 month comparison|Wilcoxon (Mann-Whitney)|||||||0.23
72598651|NCT02494401|144728059|SUPERIORITY|||||||0.93||||||p value of baseline comparison|Wilcoxon (Mann-Whitney)|||||||0.93
72598652|NCT02494401|144728059|SUPERIORITY|||||||0.54||||||p value of 16 week comparison|Wilcoxon (Mann-Whitney)|||||||0.54
72598653|NCT02494401|144728059|SUPERIORITY|||||||0.33||||||p value of 6 month comparison|Wilcoxon (Mann-Whitney)|||||||0.33
72598654|NCT02494401|144728060|SUPERIORITY|||||||0.59||||||p value of baseline comparison|Wilcoxon (Mann-Whitney)|||||||0.59
72598655|NCT02494401|144728060|SUPERIORITY|||||||0.25||||||p value of 16 week comparison|Wilcoxon (Mann-Whitney)|||||||0.25
72598656|NCT02494401|144728060|SUPERIORITY|||||||0.12||||||p value of 6 month comparison|Wilcoxon (Mann-Whitney)|||||||0.12
72598657|NCT02494401|144728061|SUPERIORITY|||||||0.51||||||p value of baseline comparison|Wilcoxon (Mann-Whitney)|||||||0.51
72598658|NCT02494401|144728061|SUPERIORITY|||||||0.93||||||p value of 16 week comparison|Wilcoxon (Mann-Whitney)|||||||0.93
72598659|NCT02494401|144728061|SUPERIORITY|||||||0.84||||||p value of 6 month comparison|Wilcoxon (Mann-Whitney)|||||||0.84
72598660|NCT02494401|144728062|SUPERIORITY|||||||0.83||||||p value of baseline comparison|Wilcoxon (Mann-Whitney)|||||||0.83
72598661|NCT02494401|144728062|SUPERIORITY|||||||0.27||||||p value of 16 week comparison|Wilcoxon (Mann-Whitney)|||||||0.27
72598662|NCT02494401|144728062|SUPERIORITY|||||||0.18||||||p value of 6 month comparison|Wilcoxon (Mann-Whitney)|||||||0.18
72598663|NCT02494401|144728063|SUPERIORITY|||||||0.64||||||p value of baseline comparison|Wilcoxon (Mann-Whitney)|||||||0.64
72598664|NCT02494401|144728063|SUPERIORITY|||||||0.8||||||p value of 16 week comparison|Wilcoxon (Mann-Whitney)|||||||0.8
72598665|NCT02494401|144728063|SUPERIORITY|||||||0.09||||||p value of 6 month comparison|Wilcoxon (Mann-Whitney)|||||||0.09
72598666|NCT02494401|144728064|SUPERIORITY|||||||0.73||||||p value of baseline comparison|Wilcoxon (Mann-Whitney)|||||||0.73
72598667|NCT02494401|144728064|SUPERIORITY|||||||0.82||||||p value of 16 week comparison|Wilcoxon (Mann-Whitney)|||||||0.82
72598668|NCT02494401|144728064|SUPERIORITY|||||||0.04||||||p value of 6 month comparison|Wilcoxon (Mann-Whitney)|||||||0.04
72598669|NCT02494401|144728065|SUPERIORITY|||||||0.95||||||p value of baseline comparison|Wilcoxon (Mann-Whitney)|||||||0.95
72598670|NCT02494401|144728065|SUPERIORITY|||||||0.87||||||p value of 16 week comparison|Wilcoxon (Mann-Whitney)|||||||0.87
72598671|NCT02494401|144728065|SUPERIORITY|||||||0.63||||||p value of 6 month comparison|Wilcoxon (Mann-Whitney)|||||||0.63
72598672|NCT02494401|144728066|SUPERIORITY|||||||0.05||||||p value of baseline comparison|Wilcoxon (Mann-Whitney)|||||||0.05
72598673|NCT02494401|144728066|SUPERIORITY|||||||0.62||||||p value of 16 week comparison|Wilcoxon (Mann-Whitney)|||||||0.62
72598674|NCT02494401|144728066|SUPERIORITY|||||||0.7||||||p value of 6 month comparison|Wilcoxon (Mann-Whitney)|||||||0.7
72598675|NCT02494401|144728067|SUPERIORITY|||||||0.29||||||p value of baseline comparison|Wilcoxon (Mann-Whitney)|||||||0.29
72598676|NCT02494401|144728067|SUPERIORITY|||||||0.58||||||p value of 16 week comparison|Wilcoxon (Mann-Whitney)|||||||0.58
72598677|NCT02494401|144728067|SUPERIORITY|||||||0.49||||||p value of 6 month comparison|Wilcoxon (Mann-Whitney)|||||||0.49
72598678|NCT02494401|144728068|SUPERIORITY|||||||0.87||||||p value of baseline comparison|Wilcoxon (Mann-Whitney)|||||||0.87
72598679|NCT02494401|144728068|SUPERIORITY|||||||0.89||||||p value of 16 week comparison|Wilcoxon (Mann-Whitney)|||||||0.89
72598680|NCT02494401|144728068|SUPERIORITY|||||||0.82||||||p value of 6 month comparison|Wilcoxon (Mann-Whitney)|||||||0.82
72598681|NCT00904917|144728118|SUPERIORITY_OR_OTHER|||||||0.015|TWO_SIDED||||||t-test, 2 sided|||||||.015
72598682|NCT00904917|144728120|SUPERIORITY_OR_OTHER|||||||0.037|TWO_SIDED||||||Regression, Linear|||||||.037
72598683|NCT05206734|144728123|OTHER||Hazard Ratio (HR)|1.28|||||TWO_SIDED|95.0|1.12|1.46|||||HR was calculated using a Cox Proportional Hazard model adjusted for age,sex,socioeconomic status, ethnicity and common childhood conditions. Reflects a comparison of the incidence rates between participants diagnosed with IBD and those without IBD.|||1.46|1.12|
72598684|NCT05206734|144728124|OTHER||Risk Ratio (RR)|1.82|||||TWO_SIDED|95.0|1.33|2.52|||||RR calculated using negative binomial model adjusted for age,sex,socioeconomic status,ethnicity,IBD type and comorbidities.Reflects a comparison of the incidence rate ratio between IBD participants diagnosed with and without mental health conditions.|||2.52|1.33|
72598685|NCT05206734|144728125|OTHER||Hazard Ratio (HR)|1.63|||||TWO_SIDED|95.0|1.02|2.62|||||HR calculated using Cox regression models adjusted for age,sex,socioeconomic status,ethnicity,IBD type and comorbidities.Reflects a comparison of the incidence rate ratio between IBD participants diagnosed with and without mental health conditions.|||2.62|1.02|
72598686|NCT05206734|144728126|OTHER||Risk Ratio (RR)|2.78|||||TWO_SIDED|95.0|1.76|4.43|||||RR calculated using negative binomial model adjusted for age,sex,socioeconomic status,ethnicity,IBD type and comorbidities.Reflects a comparison of the incidence rate ratio between IBD participants diagnosed with and without mental health conditions.|||4.43|1.76|
72598687|NCT05206734|144728128|OTHER||Risk Ratio (RR)|1.33|||||TWO_SIDED|95.0|1.12|1.58|||||RR calculated using negative binomial model adjusted for age,sex,socioeconomic status,ethnicity,IBD type and comorbidities.Reflects a comparison of the incidence rate ratio between IBD participants diagnosed with and without mental health conditions.|||1.58|1.12|
72598688|NCT05206734|144728129|OTHER||Risk Ratio (RR)|1.87|||||TWO_SIDED|95.0|1.29|2.75|||||RR calculated using negative binomial model adjusted for age,sex,socioeconomic status,ethnicity,IBD type and comorbidities.Reflects a comparison of the incidence rate ratio between IBD participants diagnosed with and without mental health conditions.|||2.75|1.29|
72598689|NCT02330172|144728132|SUPERIORITY|||||||0.05|||||||t-test, 2 sided|||||||0.05
72598690|NCT02330172|144728133|SUPERIORITY|||||||0.05|||||||t-test, 2 sided|||||||0.05
72598691|NCT00734656|144728134|SUPERIORITY_OR_OTHER|||||||0.28||95.0|||||t-test, 2 sided|||null hypothesis - dutasteride does not affect blood alcohol following standardized dose of alcohol (0.8 gr/kg)||||0.28
72598692|NCT00734656|144728135|SUPERIORITY_OR_OTHER|||||||0.01||95.0|||||Mixed Models Analysis|||null hypothesis: dutasteride pre-treatment does not reduce the sedative effect of alcohol||||0.010
72598693|NCT00734656|144728136|SUPERIORITY_OR_OTHER|||||||0.17||95.0|||||Mixed Models Analysis|||null hypothesis: dutasteride pre-treatment does not reduce the stimulating effect of alcohol||||0.17
72598694|NCT00734656|144728137|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||null hypothesis - A single 4 mg dose of dutasteride does not reduce serum 3a-androstanediol glucuronide levels||||<0.001
72598695|NCT02081014|144728142|SUPERIORITY_OR_OTHER||Point estimate ratio|0.62|STANDARD_ERROR_OF_MEAN|0.07|<|0.05|TWO_SIDED||||||Mixed Models Analysis||Geometric means|||||<0.05
72598696|NCT02081014|144728142|SUPERIORITY_OR_OTHER||Point estimate ratio|0.35|STANDARD_ERROR_OF_MEAN|0.04|<|0.05|TWO_SIDED||||||Mixed Models Analysis||Geometric means|||||<0.05
72598697|NCT02081014|144728142|SUPERIORITY_OR_OTHER||Point estimate ratio|0.57|STANDARD_ERROR_OF_MEAN|0.06|<|0.05|TWO_SIDED||||||Mixed Models Analysis||Geometric means|||||<0.05
72598698|NCT02081014|144728143|SUPERIORITY_OR_OTHER||Point estimate ratio|0.74|STANDARD_ERROR_OF_MEAN|0.06|<|0.05|TWO_SIDED||||||Mixed Models Analysis||Geometric means|||||<0.05
72598699|NCT02081014|144728143|SUPERIORITY_OR_OTHER||Point estimate ratio|0.44|STANDARD_ERROR_OF_MEAN|0.04|<|0.05|TWO_SIDED||||||Mixed Models Analysis||Geometric means|||||<0.05
72598700|NCT02081014|144728143|SUPERIORITY_OR_OTHER||Point estimate ratio|0.59|STANDARD_ERROR_OF_MEAN|0.05|<|0.05|TWO_SIDED||||||Mixed Models Analysis||Geometric means|||||<0.05
72598701|NCT02081014|144728144|SUPERIORITY_OR_OTHER||Point point ratio|0.68|STANDARD_ERROR_OF_MEAN|0.05|<|0.05|TWO_SIDED||||||Mixed Models Analysis||Geometric means|||||<0.05
72598702|NCT02081014|144728144|SUPERIORITY_OR_OTHER||Point estimate ratio|0.36|STANDARD_ERROR_OF_MEAN|0.03|<|0.05|TWO_SIDED||||||Mixed Models Analysis||Geometric means|||||<0.05
72598703|NCT02081014|144728144|SUPERIORITY_OR_OTHER||Point estimate ratio|0.53|STANDARD_ERROR_OF_MEAN|0.04|<|0.05|TWO_SIDED||||||Mixed Models Analysis||Geometric means|||||<0.05
72598704|NCT02081014|144728145|SUPERIORITY_OR_OTHER||Point estimate ratio|0.72|STANDARD_ERROR_OF_MEAN|0.04|<|0.05|TWO_SIDED||||||Mixed Models Analysis||Geometric means|||||<0.05
72598705|NCT02081014|144728145|SUPERIORITY_OR_OTHER||Point estimate ratio|0.44|STANDARD_ERROR_OF_MEAN|0.02|<|0.05|TWO_SIDED||||||Mixed Models Analysis||Geometric means|||||<0.05
72598706|NCT02081014|144728145|SUPERIORITY_OR_OTHER||Point estimate ratio|0.6|STANDARD_ERROR_OF_MEAN|0.03|<|0.05|TWO_SIDED||||||Mixed Models Analysis||Geometric means|||||<0.05
72598707|NCT02081014|144728146|SUPERIORITY_OR_OTHER||Point esimate ratio|0.98|STANDARD_ERROR_OF_MEAN|0.14|>|0.05|TWO_SIDED||||||Mixed Models Analysis||Geometric means|||||>0.05
72598708|NCT02081014|144728146|SUPERIORITY_OR_OTHER||Point estimate ratio|0.78|STANDARD_ERROR_OF_MEAN|0.11|>|0.05|TWO_SIDED||||||Mixed Models Analysis||Geometric means|||||>0.05
72598709|NCT02081014|144728146|SUPERIORITY_OR_OTHER||Point estimate ratio|0.79|STANDARD_ERROR_OF_MEAN|0.11|>|0.05|TWO_SIDED||||||Mixed Models Analysis||Geometric means|||||>0.05
72598710|NCT02081014|144728147|SUPERIORITY_OR_OTHER||Point estimate ratio|0.75|STANDARD_ERROR_OF_MEAN|0.1|>|0.05|TWO_SIDED||||||Mixed Models Analysis||Geometric means|||||>0.05
72598711|NCT02081014|144728147|SUPERIORITY_OR_OTHER||Point estimate ratio|0.73|STANDARD_ERROR_OF_MEAN|0.1|<|0.05|TWO_SIDED||||||Mixed Models Analysis||Geometric means|||||<0.05
72598712|NCT02081014|144728147|SUPERIORITY_OR_OTHER||Point estimate ratio|0.96|STANDARD_ERROR_OF_MEAN|0.13|>|0.05|TWO_SIDED||||||Mixed Models Analysis||Geometric means|||||>0.05
72598713|NCT02081014|144728148|SUPERIORITY_OR_OTHER||Point estimate ratio|0.82|STANDARD_ERROR_OF_MEAN|0.06|<|0.05|TWO_SIDED||||||Mixed Models Analysis||Geometric means|||||<0.05
72598714|NCT02081014|144728148|SUPERIORITY_OR_OTHER||Point estimate ratio|0.7|STANDARD_ERROR_OF_MEAN|0.05|<|0.05|TWO_SIDED||||||Mixed Models Analysis||Geometric means|||||<0.05
72598715|NCT02081014|144728148|SUPERIORITY_OR_OTHER||Point estimate ratio|0.85|STANDARD_ERROR_OF_MEAN|0.06|<|0.05|TWO_SIDED||||||Mixed Models Analysis||Geometric means|||||<0.05
72598716|NCT02081014|144728149|SUPERIORITY_OR_OTHER||Point estimate ratio|0.96|STANDARD_ERROR_OF_MEAN|0.08|>|0.05|TWO_SIDED||||||Mixed Models Analysis||Geometric means|||||>0.05
72598717|NCT02081014|144728149|SUPERIORITY_OR_OTHER||Point estimate ratio|0.83|STANDARD_ERROR_OF_MEAN|0.06|<|0.05|TWO_SIDED||||||Mixed Models Analysis||Geometric means|||||<0.05
72598718|NCT02081014|144728149|SUPERIORITY_OR_OTHER||Point estimate ratio|0.86|STANDARD_ERROR_OF_MEAN|0.06|>|0.05|TWO_SIDED||||||Mixed Models Analysis||Geometric means|||||>0.05
72598719|NCT02081014|144728150|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3693.2|STANDARD_ERROR_OF_MEAN|1520.1|<|0.05|TWO_SIDED||||||Mixed Models Analysis|||||||<0.05
72598720|NCT02081014|144728150|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7548.05|STANDARD_ERROR_OF_MEAN|1542.93||0.05|TWO_SIDED||||||Mixed Models Analysis|||||||0.05
72598721|NCT02081014|144728150|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3854.86|STANDARD_ERROR_OF_MEAN|1533.95|<|0.05|TWO_SIDED||||||Mixed Models Analysis|||||||<0.05
72598722|NCT02081014|144728151|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-144.9|STANDARD_ERROR_OF_MEAN|741.24|>|0.05|TWO_SIDED||||||Mixed Models Analysis|||||||>0.05
72598723|NCT02081014|144728151|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1665.32|STANDARD_ERROR_OF_MEAN|696.97|<|0.05|TWO_SIDED||||||Mixed Models Analysis|||||||<0.05
72598724|NCT02081014|144728151|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1520.39|STANDARD_ERROR_OF_MEAN|700.92|>|0.05|TWO_SIDED||||||Mixed Models Analysis|||||||>0.05
72598725|NCT02081014|144728152|SUPERIORITY_OR_OTHER||Point estimate ratio|0.41|STANDARD_ERROR_OF_MEAN|0.32|>|0.05|TWO_SIDED||||||Mixed Models Analysis||Geometric means|||||>0.05
72598726|NCT02081014|144728152|SUPERIORITY_OR_OTHER||Point estimate ratio|0.43|STANDARD_ERROR_OF_MEAN|0.34|>|0.05|TWO_SIDED||||||Mixed Models Analysis||Geometric means|||||>0.05
72598727|NCT02081014|144728152|SUPERIORITY_OR_OTHER||Point estimate ratio|1.05|STANDARD_ERROR_OF_MEAN|0.81|>|0.05|TWO_SIDED||||||Mixed Models Analysis||Geometric means|||||>0.05
72598728|NCT02081014|144728153|SUPERIORITY_OR_OTHER||Point estimate ratio|0.23|STANDARD_ERROR_OF_MEAN|0.29|>|0.05|TWO_SIDED||||||Mixed Models Analysis||Geometric means|||||>0.05
72598729|NCT02081014|144728153|SUPERIORITY_OR_OTHER||Point estimate ratio|0.73|STANDARD_ERROR_OF_MEAN|0.88|>|0.05|TWO_SIDED||||||Mixed Models Analysis||Geometric means|||||>0.05
72598730|NCT02081014|144728153|SUPERIORITY_OR_OTHER||Point estimate ratio|3.23|STANDARD_ERROR_OF_MEAN|3.84|>|0.05|TWO_SIDED||||||Regression, Linear||Geometric means|||||>0.05
72598731|NCT01031004|144728184|SUPERIORITY_OR_OTHER|||||||0.0466||95.0|||||Fisher Exact|||The hypothesis is that narafilcon B is not statistically different from etafilcon A.||||0.0466
72598732|NCT01031004|144728185|SUPERIORITY_OR_OTHER|||||||0.1069||95.0|||||Fisher Exact|||The hypothesis is that narafilcon B is not statistically different from etafilcon A.||||0.1069
72598733|NCT01031004|144728186|SUPERIORITY_OR_OTHER|||||||0.4605||95.0|||||Chi-squared|||The hypothesis is that narafilcon B is not statistically different from etafilcon A.||||0.4605
72598734|NCT01031004|144728187|SUPERIORITY_OR_OTHER|||||||0.5774||95.0|||||Chi-squared|||The hypothesis is that narafilcon B is not statistically different from etafilcon A.||||0.5774
72598735|NCT01031004|144728188|SUPERIORITY_OR_OTHER|||||||0.6403||95.0|||||t-test, 2 sided|||The hypothesis is that narafilcon B will not be statistically different from etafilcon A.||||0.6403
72598736|NCT01031004|144728189|SUPERIORITY_OR_OTHER|||||||0.7217||95.0|||||t-test, 2 sided|||The hypothesis is that narafilcon B is not statistically different from etafilcon A.||||0.7217
72598737|NCT02634801|144728199|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|4.08|||<|0.0001|TWO_SIDED|95.0|2.46|6.77|||Fisher Exact|||||6.77|2.46|<.0001
72598738|NCT02634801|144728199|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|1.29||||0.0137|TWO_SIDED|95.0|1.06|1.56|||Fisher Exact|||||1.56|1.06|0.0137
72598739|NCT03543176|144728228|OTHER|||||||0.448||||||P-value for low impact of COPD is presented|Fisher Exact|||||||0.448
72598740|NCT03543176|144728228|OTHER|||||||0.033||||||P-value for medium impact of COPD is presented|Fisher Exact|||||||0.033
72598741|NCT03543176|144728228|OTHER|||||||0.172||||||P-value for high impact of COPD is presented|Fisher Exact|||||||0.172
72598742|NCT03543176|144728228|OTHER|||||||0.01||||||P-value for very high impact of COPD is presented|Fisher Exact|||||||0.010
72598743|NCT03543176|144728229|OTHER|||||||0.176||||||P-value for breathlessness reported in COPD assessed using mMRC is presented|Fisher Exact|||||||0.176
72598744|NCT03543176|144728230|OTHER|||||||0.732||||||P-value for Baseline comorbidity burden score was calculated.|t-test, 2 sided|||||||0.732
72598745|NCT03543176|144728231|OTHER|||||||0.013||||||P-value for count of unique medications was calculated.|t-test, 2 sided|||||||0.013
72598746|NCT03543176|144728232|OTHER|||||||0.178||||||P-value for total number of medications dispensing was calculated.|t-test, 2 sided|||||||0.178
72598747|NCT03543176|144728238|OTHER|||||||0.692||||||P-value for count of unique COPD medications was calculated|t-test, 2 sided|||||||0.692
72415812|NCT01680328|144342431|SUPERIORITY_OR_OTHER||Least Square Mean Difference|0.5||||||95.0|-0.7|1.8||||||Backflow (absorbed amount of liquid 2 minutes (±30 sec) after the injection with filter-paper rated according to the liquid scale) was analysed using a mixed ANOVA approach and calculated as the mean differences in backflow in the abdomen at different volume and speed combinations.||1.8|-0.7|
72598748|NCT03543176|144728239|OTHER||||||<|0.001||||||P-value for total number of COPD medications dispensing was calculated|t-test, 2 sided|||||||<0.001
72598749|NCT03300050|144728277|OTHER||GMT Ratio|2.73|||<|0.0001|TWO_SIDED|95.0|1.73|4.29|||ANCOVA||GMT ratio computed after fitting an analysis of covariance (ANCOVA) model on the log10 transformed titers, including vaccine group as fixed effect and the pre-vaccination titer as covariate.|Comparison of Anti-H1 HA-stalk IgG (Serum) Humoral Response: Adjusted Geometric Mean Titer (GMT) Ratio 28 Days Post-Boost Dose||4.29|1.73|<0.0001
72598750|NCT03300050|144728277|OTHER||GMT Ratio|1.06||||0.9411|TWO_SIDED|95.0|0.68|1.66|||ANCOVA||GMT ratio computed after fitting an analysis of covariance (ANCOVA) model on the log10 transformed titers, including vaccine group as fixed effect and the pre-vaccination titer as covariate.|Comparison of Anti-H1 HA-stalk IgG (Serum) Humoral Response: Adjusted GMT Ratio 28 Days Post-Boost Dose||1.66|0.68|0.9411
72598751|NCT03300050|144728277|OTHER||GMT Ratio|0.39|||<|0.0001|TWO_SIDED|95.0|0.24|0.62|||ANCOVA||GMT ratio computed after fitting an analysis of covariance (ANCOVA) model on the log10 transformed titers, including vaccine group as fixed effect and the pre-vaccination titer as covariate.|Comparison of Anti-H1 HA-stalk IgG (Serum) Humoral Response: Adjusted GMT Ratio 28 Days Post-Boost Dose||0.62|0.24|<0.0001
72598752|NCT03300050|144728278|OTHER||Difference|59.6||||0.0025|TWO_SIDED|95.0|23.59|81.02|||Fisher Exact|||Comparison of Anti-H1 HA-stalk IgG (Serum) Humoral Response: Seroresponse (≥4-fold) Rate 28 Days Post-Boost Dose||81.02|23.59|0.0025
72598753|NCT03300050|144728278|OTHER||Difference|17.9||||0.4421|TWO_SIDED|95.0|-16.24|49.0|||Fisher Exact|||Comparison of Anti-H1 HA-stalk IgG (Serum) Humoral Response: Seroresponse (≥4-fold) Rate 28 Days Post-Boost Dose||49.00|-16.24|0.4421
72598754|NCT03300050|144728278|OTHER||Difference|-41.8||||0.0461|TWO_SIDED|95.0|-68.75|-4.8|||Fisher Exact|||Comparison of Anti-H1 HA-stalk IgG (Serum) Humoral Response: Seroresponse (≥4-fold) Rate 28 Days Post-Boost Dose||-4.80|-68.75|0.0461
72598755|NCT03300050|144728282|OTHER||GMT Ratio|1.71||||0.1665|TWO_SIDED|95.0|0.84|3.48|||ANCOVA||GMT ratio computed after fitting an analysis of covariance (ANCOVA) model on the log10 transformed titers, including vaccine group as fixed effect and the pre-vaccination titer as covariate.|Comparison of Anti-H1 HA-stalk IgA (Serum) Humoral Response: Adjusted GMT Ratio 28 Days Post-Boost Dose||3.48|0.84|0.1665
72598756|NCT03300050|144728282|OTHER||GMT Ratio|1.1||||0.9377|TWO_SIDED|95.0|0.55|2.2|||ANCOVA||GMT ratio computed after fitting an analysis of covariance (ANCOVA) model on the log10 transformed titers, including vaccine group as fixed effect and the pre-vaccination titer as covariate.|Comparison of Anti-H1 HA-stalk IgA (Serum) Humoral Response: Adjusted GMT Ratio 28 Days Post-Boost Dose||2.20|0.55|0.9377
72598757|NCT03300050|144728282|OTHER||GMT Ratio|0.64||||0.3088|TWO_SIDED|95.0|0.31|1.33|||ANCOVA||GMT ratio computed after fitting an analysis of covariance (ANCOVA) model on the log10 transformed titers, including vaccine group as fixed effect and the pre-vaccination titer as covariate.|Comparison of Anti-H1 HA-stalk IgG (Serum) Humoral Response: Adjusted GMT Ratio 28 Days Post-Boost Dose||1.33|0.31|0.3088
72598758|NCT03300050|144728283|OTHER||Difference|16.3||||0.4667|TWO_SIDED|95.0|-19.85|48.88|||Fisher Exact|||Comparison of Anti-H1 HA-stalk IgG (Serum) Humoral Response: Seroresponse (≥4-fold) Rate 28 Days Post-Boost Dose||48.88|-19.85|0.4667
72598759|NCT03300050|144728283|OTHER||Difference|-1.8|||>|0.9999|TWO_SIDED|95.0|-34.76|32.17|||Fisher Exact|||Comparison of Anti-H1 HA-stalk IgG (Serum) Humoral Response: Seroresponse (≥4-fold) Rate 28 Days Post-Boost Dose||32.17|-34.76|>0.9999
72598760|NCT03300050|144728283|OTHER||Difference|-18.1||||0.4495|TWO_SIDED|95.0|-51.15|19.37|||Fisher Exact|||Comparison of Anti-H1 HA-stalk IgG (Serum) Humoral Response: Seroresponse (≥4-fold) Rate 28 Days Post-Boost Dose||19.37|-51.15|0.4495
72598761|NCT03300050|144728287|OTHER||GMT Ratio|1.61||||0.0928|TWO_SIDED|95.0|0.94|2.77|||ANCOVA||GMT ratio computed after fitting an analysis of covariance (ANCOVA) model on the log10 transformed titers, including vaccine group as fixed effect and the pre-vaccination titer as covariate.|Comparison of Anti-H1 HA-stalk MN (Serum) Assay: Adjusted GMT Ratio 28 Days Post-Boost Dose||2.77|0.94|0.0928
72598762|NCT03300050|144728287|OTHER||GMT Ratio|1.32||||0.4198|TWO_SIDED|95.0|0.77|2.26|||ANCOVA||GMT ratio computed after fitting an analysis of covariance (ANCOVA) model on the log10 transformed titers, including vaccine group as fixed effect and the pre-vaccination titer as covariate.|Comparison of Anti-H1 HA-stalk MN (Serum) Assay: Adjusted GMT Ratio 28 Days Post-Boost Dose||2.26|0.77|0.4198
72598763|NCT03300050|144728287|OTHER||GMT Ratio|0.82||||0.6754|TWO_SIDED|95.0|0.47|1.45|||ANCOVA||GMT ratio computed after fitting an analysis of covariance (ANCOVA) model on the log10 transformed titers, including vaccine group as fixed effect and the pre-vaccination titer as covariate.|Comparison of Anti-H1 HA-stalk MN (Serum) Assay: Adjusted GMT Ratio 28 Days Post-Boost Dose||1.45|0.47|0.6754
72598764|NCT03300050|144728288|OTHER||Difference|19.2||||0.4515|TWO_SIDED|95.0|-17.19|50.49|||Fisher Exact|||Comparison of Anti-H1 HA-stalk MN (Serum) Assay: Seroresponse (\>4-Fold) Rate 28 Days Post-Boost Dose||50.49|-17.19|0.4515
72598765|NCT03300050|144728288|OTHER||Difference|14.3||||0.4837|TWO_SIDED|95.0|-21.22|46.19|||Fisher Exact|||Comparison of Anti-H1 HA-stalk MN (Serum) Assay: Seroresponse (\>4-Fold) Rate 28 Days Post-Boost Dose||46.19|-21.22|0.4837
72598766|NCT03300050|144728288|OTHER||Difference|-4.9|||>|0.9999|TWO_SIDED|95.0|-38.8|30.46|||Fisher Exact|||Comparison of Anti-H1 HA-stalk MN (Serum) Assay: Seroresponse (\>4-Fold) Rate 28 Days Post-Boost Dose||30.46|-38.80|>0.9999
72598767|NCT03300050|144728291|OTHER||Difference|2.93||||0.0031|TWO_SIDED|95.0|1.56|7.49|||Wilcoxon (Mann-Whitney)||Based on log10 AUC, using the Hodges-Lehmann location parameter difference back-transformed to the original scale.|Comparison of Serum cH6/1 - ADCC Activity: AUC at 28 Days Post-Boost||7.49|1.56|0.0031
72598768|NCT03300050|144728291|OTHER||Difference|1.25||||0.2048|TWO_SIDED|95.0|0.73|2.23|||Wilcoxon (Mann-Whitney)||Based on log10 AUC, using the Hodges-Lehmann location parameter difference back-transformed to the original scale.|Comparison of Serum cH6/1 - ADCC Activity: AUC at 28 Days Post-Boost||2.23|0.73|0.2048
72598769|NCT03300050|144728291|OTHER||Difference|0.43||||0.0392|TWO_SIDED|95.0|0.18|1.0|||Wilcoxon (Mann-Whitney)|||Comparison of Serum cH6/1 - ADCC Activity: AUC at 28 Days Post-Boost||1.00|0.18|0.0392
72598770|NCT03300050|144728292|OTHER||Difference|1.16||||0.8243|TWO_SIDED|95.0|0.14|4.95|||Wilcoxon (Mann-Whitney)||Based on the Hodges-Lehmann location parameter difference on the log scale then back-transformed to the original scale.|Comparison of Serum cH6/1 - ADCC Activity: Fold Increase in AUC at 28 Days Post-Boost||4.95|0.14|0.8243
72598771|NCT03300050|144728292|OTHER||Difference|1.74||||0.253|TWO_SIDED|95.0|0.67|6.06|||Wilcoxon (Mann-Whitney)||Based on the Hodges-Lehmann location parameter difference on the log scale then back-transformed to the original scale.|Comparison of Serum cH6/1 - ADCC Activity: Fold Increase in AUC at 28 Days Post-Boost||6.06|0.67|0.2530
72598772|NCT03300050|144728292|OTHER||Difference|1.83||||0.5654|TWO_SIDED|95.0|0.47|39.92|||Wilcoxon (Mann-Whitney)||Based on the Hodges-Lehmann location parameter difference on the log scale then back-transformed to the original scale.|Comparison of Serum cH6/1 - ADCC Activity: Fold Increase in AUC at 28 Days Post-Boost||39.92|0.47|0.5654
72598773|NCT03300050|144728296|OTHER||GMT Ratio|1.21||||0.883|TWO_SIDED|95.0|0.45|3.27|||ANCOVA||GMT ratio computed after fitting an analysis of covariance (ANCOVA) model on the log10 transformed titers, including vaccine group as fixed effect and the pre-vaccination titer as covariate.|Comparison of Anti-H1 HA-stalk IgG (Saliva), Mucosal Response: Adjusted GMT Ratio 28 Days Post-Boost Dose||3.27|0.45|0.8830
72415813|NCT01680328|144342431|SUPERIORITY_OR_OTHER||Least Square Mean Difference|0.9||||||95.0|-0.3|2.1||||||Backflow (absorbed amount of liquid 2 minutes (±30 sec) after the injection with filter-paper rated according to the liquid scale) was analysed using a mixed ANOVA approach and calculated as the mean differences in backflow in the abdomen at different volume and speed combinations.||2.1|-0.3|
72598774|NCT03300050|144728296|OTHER||GMT Ratio|0.86||||0.9238|TWO_SIDED|95.0|0.33|2.26|||ANCOVA||GMT ratio computed after fitting an analysis of covariance (ANCOVA) model on the log10 transformed titers, including vaccine group as fixed effect and the pre-vaccination titer as covariate.|Comparison of Anti-H1 HA-stalk IgG (Saliva), Mucosal Response: Adjusted GMT Ratio 28 Days Post-Boost Dose||2.26|0.33|0.9238
72598775|NCT03300050|144728296|OTHER||GMT Ratio|0.71||||0.6926|TWO_SIDED|95.0|0.26|1.97|||ANCOVA||GMT ratio computed after fitting an analysis of covariance (ANCOVA) model on the log10 transformed titers, including vaccine group as fixed effect and the pre-vaccination titer as covariate.|Comparison of Anti-H1 HA-stalk IgG (Saliva), Mucosal Response: Adjusted GMT Ratio 28 Days Post-Boost Dose||1.97|0.26|0.6926
72415814|NCT01680328|144342431|SUPERIORITY_OR_OTHER||Least Square Mean Difference|0.8||||||95.0|-0.4|2.0||||||Backflow (absorbed amount of liquid 2 minutes (±30 sec) after the injection with filter-paper rated according to the liquid scale) was analysed using a mixed ANOVA approach and calculated as the mean differences in backflow in the abdomen at different volume and speed combinations.||2.0|-0.4|
72598776|NCT03300050|144728297|OTHER||Difference|11.7||||0.7036|TWO_SIDED|95.0|-25.72|45.82|||Fisher Exact|||Comparison of Anti-H1 HA-stalk IgG (Saliva), Mucosal Response: Seroresponse (≥4-fold) Rate 28 Days Post-Boost Dose||45.82|-25.72|0.7036
72598777|NCT03300050|144728297|OTHER||Difference|-3.8|||>|0.9999|TWO_SIDED|95.0|-37.9|31.31|||Fisher Exact|||Comparison of Anti-H1 HA-stalk IgG (Saliva), Mucosal Response: Seroresponse (≥4-fold) Rate 28 Days Post-Boost Dose||31.31|-37.90|>0.9999
72598778|NCT03300050|144728297|OTHER||Difference|-15.5||||0.6951|TWO_SIDED|95.0|-49.56|22.79|||Fisher Exact|||Comparison of Anti-H1 HA-stalk IgG (Saliva), Mucosal Response: Seroresponse (≥4-fold) Rate 28 Days Post-Boost Dose||22.79|-49.56|0.6951
72598779|NCT03300050|144728301|OTHER||GMT Ratio|0.65||||0.3203|TWO_SIDED|95.0|0.32|1.33|||ANCOVA||GMT ratio computed after fitting an analysis of covariance (ANCOVA) model on the log10 transformed titers, including vaccine group as fixed effect and the pre-vaccination titer as covariate.|Comparison of Anti-H1 HA-stalk Secretory IgA (Saliva), Mucosal Response: Adjusted GMT Ratio 28 Days post-Boost Dose||1.33|0.32|0.3203
72598780|NCT03300050|144728301|OTHER||GMT Ratio|0.72||||0.5009|TWO_SIDED|95.0|0.35|1.47|||ANCOVA||GMT ratio computed after fitting an analysis of covariance (ANCOVA) model on the log10 transformed titers, including vaccine group as fixed effect and the pre-vaccination titer as covariate.|Comparison of Anti-H1 HA-stalk Secretory IgA (Saliva), Mucosal Response: Adjusted GMT Ratio 28 Days post-Boost Dose||1.47|0.35|0.5009
72598781|NCT03300050|144728301|OTHER||GMT Ratio|1.1||||0.9542|TWO_SIDED|95.0|0.51|2.37|||ANCOVA||GMT ratio computed after fitting an analysis of covariance (ANCOVA) model on the log10 transformed titers, including vaccine group as fixed effect and the pre-vaccination titer as covariate.|Comparison of Anti-H1 HA-stalk Secretory IgA (Saliva), Mucosal Response: Adjusted GMT Ratio 28 Days post-Boost Dose||2.37|0.51|0.9542
72598782|NCT03300050|144728302|OTHER||Difference|-1.7|||>|0.9999|TWO_SIDED|95.0|-30.62|23.79|||Fisher Exact|||Comparison of Anti-H1 HA-stalk Secretory IgA (Saliva), Mucosal Response: Seroresponse (≥4-fold) Rate 28 Days post-Boost Dose||23.79|-30.62|>0.9999
72598783|NCT03300050|144728302|OTHER||Difference|6.7|||>|0.9999|TWO_SIDED|95.0|-16.24|30.34|||Fisher Exact|||Comparison of Anti-H1 HA-stalk Secretory IgA (Saliva), Mucosal Response: Seroresponse (≥4-fold) Rate 28 Days post-Boost Dose||30.34|-16.24|>0.9999
72598784|NCT03300050|144728302|OTHER||Difference|8.3||||0.4615|TWO_SIDED|95.0|-19.94|36.04|||Fisher Exact|||Comparison of Anti-H1 HA-stalk Secretory IgA (Saliva), Mucosal Response: Seroresponse (≥4-fold) Rate 28 Days post-Boost Dose||36.04|-19.94|0.4615
72598785|NCT03300050|144728306|OTHER||GMT Ratio|1.2||||0.9164|TWO_SIDED|95.0|0.38|3.8|||ANCOVA||GMT ratio computed after fitting an analysis of covariance (ANCOVA) model on the log10 transformed titers, including vaccine group as fixed effect and the pre-vaccination titer as covariate.|Comparison of Anti-H1 HA-stalk Total IgA (Saliva), Mucosal Response: Adjusted GMT Ratio 28 Days Post-Boost Dose||3.80|0.38|0.9164
72598786|NCT03300050|144728306|OTHER||GMT Ratio|0.76||||0.8642|TWO_SIDED|95.0|0.21|2.79|||ANCOVA||GMT ratio computed after fitting an analysis of covariance (ANCOVA) model on the log10 transformed titers, including vaccine group as fixed effect and the pre-vaccination titer as covariate.|Comparison of Anti-H1 HA-stalk Total IgA (Saliva), Mucosal Response: Adjusted GMT Ratio 28 Days Post-Boost Dose||2.79|0.21|0.8642
72598787|NCT03300050|144728306|OTHER||GMT Ratio|0.63||||0.6545|TWO_SIDED|95.0|0.18|2.27|||ANCOVA||GMT ratio computed after fitting an analysis of covariance (ANCOVA) model on the log10 transformed titers, including vaccine group as fixed effect and the pre-vaccination titer as covariate.|Comparison of Anti-H1 HA-stalk Total IgA (Saliva), Mucosal Response: Adjusted GMT Ratio 28 Days Post-Boost Dose||2.27|0.18|0.6545
72598788|NCT03300050|144728307|OTHER||Difference|7.7|||>|0.9999|TWO_SIDED|95.0|-27.1|40.96|||Fisher Exact|||Comparison of Anti-H1 HA-stalk Total IgA (Saliva), Mucosal Response: Seroresponse (\>4-Fold) Rate 28 Days Post-Boost Dose||40.96|-27.10|>0.9999
72598789|NCT03300050|144728307|OTHER||Difference|30.8||||0.1045|TWO_SIDED|95.0|-1.76|58.19|||Fisher Exact|||Comparison of Anti-H1 HA-stalk Total IgA (Saliva), Mucosal Response: Seroresponse (≥4-fold) Rate 28 Days Post-Boost Dose||58.19|-1.76|0.1045
72598790|NCT03300050|144728307|OTHER||Difference|23.1||||0.2292|TWO_SIDED|95.0|-8.62|50.86|||Fisher Exact|||Comparison of Anti-H1 HA-stalk Total IgA (Saliva), Mucosal Response: Seroresponse (≥4-fold) Rate 28 Days Post-Boost Dose||50.86|-8.62|0.2292
72598791|NCT02178358|144728340|SUPERIORITY||Hazard Ratio (HR)|0.776||||0.837|TWO_SIDED|95.0|0.434|1.226|||Bayesian exponential-likelihood model|||||1.226|0.434|0.837
72598792|NCT02178358|144728340|SUPERIORITY||Hazard Ratio (HR)|0.917||||0.704|TWO_SIDED|95.0|0.633|1.266|||Bayesian exponential-likelihood model|||||1.266|0.633|0.704
72598793|NCT03539484|144728360|OTHER|A Bayesian approach is used to estimate the maximum tolerated dose (MTD).|Posterior probability at dose 1.8 mg|10.6|||||TWO_SIDED|95.0|2.1|26.5||There is no p-value derived; logistic regression is used to estimate the probability of DLT.|Regression, Logistic|||||26.5|2.10|
72598794|NCT00560703|144728392|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Power calculation for this endpoint was driven by the assumptions made for the OSDI analysis||||||0.578||95.0|||||ANCOVA|||||||0.578
72598795|NCT00560703|144728393|SUPERIORITY_OR_OTHER_LEGACY|||||||0.293||95.0|||||ANCOVA|||It was anticipated that the difference between the treatment groups in mean reduction from baseline in OSDI scores will be approximately 7 points. A pooled standard deviation of 9.0 for the mean change from baseline OSDI score is expected. Under those assumptions a total of approximately 63 evaluable patients (42 COL-101 patients and 21 placebo patients) is sufficient to provide 80% power. The planned enrolment should provide enough evaluable patients to meet these assumptions.||||0.293
72598796|NCT06010732|144728431|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.986|TWO_SIDED|95.0|-5.5|5.4||No alpha-level adjustments for multiple comparisons adjustments were applied.|Mixed Models Analysis|Analysis of variance models (ANOVA) suitable for a crossover study, with random effect for subject and fixed effects for study period and product.|Difference calculated as Test-Positive Control|Based on previous studies we estimate the standard deviation of the differences between treatments in the crossover model to be 20 for % SMH recovery. With a sample size of 58 subjects completing the study, the study had 80% power to detect a difference between any two treatments of 7.5 for % SMH recovery, assuming two-sided tests each conducted at a 5% significance level.||5.4|-5.5|0.986
72598797|NCT06010732|144728431|SUPERIORITY||Mean Difference (Final Values)|27.2|||<|0.001|TWO_SIDED|95.0|21.7|32.6||No alpha-level adjustments for multiple comparisons adjustments were applied.|Mixed Models Analysis|Analysis of variance models (ANOVA) suitable for a crossover study, with random effect for subject and fixed effects for study period and product.|Difference calculated as Test-Placebo|Based on previous studies we estimate the standard deviation of the differences between treatments in the crossover model to be 20 for % SMH recovery. With a sample size of 58 subjects completing the study, the study had 80% power to detect a difference between any two treatments of 7.5 for % SMH recovery, assuming two-sided tests each conducted at a 5% significance level.||32.6|21.7|<0.001
72598798|NCT06010732|144728431|SUPERIORITY||Mean Difference (Final Values)|27.2|||<|0.001|TWO_SIDED|95.0|21.7|32.7||No alpha-level adjustments for multiple comparisons adjustments were applied.|Mixed Models Analysis|Analysis of variance models (ANOVA) suitable for a crossover study, with random effect for subject and fixed effects for study period and product.|Difference calculated as Positive Control-Placebo|Based on previous studies we estimate the standard deviation of the differences between treatments in the crossover model to be 20 for % SMH recovery. With a sample size of 58 subjects completing the study, the study had 80% power to detect a difference between any two treatments of 7.5 for % SMH recovery, assuming two-sided tests each conducted at a 5% significance level.||32.7|21.7|<0.001
72598799|NCT06010732|144728432|SUPERIORITY||Ratio of Means|1.11||||0.23|TWO_SIDED|95.0|0.93|1.32||No alpha-level adjustments for multiple comparisons adjustments were applied.|Mixed Models Analysis|Analysis of variance models (ANOVA) suitable for a crossover study, with random effect for subject and fixed effects for study period and product.|Ratio calculated as Test/Positive Control|analyzed as log(EFU)||1.32|0.93|0.230
72598800|NCT06010732|144728432|SUPERIORITY||Ratio of Means|5.77|||<|0.001|TWO_SIDED|95.0|4.86|6.85||No alpha-level adjustments for multiple comparisons adjustments were applied.|Mixed Models Analysis|Analysis of variance models (ANOVA) suitable for a crossover study, with random effect for subject and fixed effects for study period and product.|Ratio calculated as Test/Placebo|analyzed as log(EFU)||6.85|4.86|<0.001
72598801|NCT06010732|144728432|SUPERIORITY||Ratio of Means|5.2|||<|0.001|TWO_SIDED|95.0|4.37|6.18||No alpha-level adjustments for multiple comparisons adjustments were applied.|Mixed Models Analysis|Analysis of variance models (ANOVA) suitable for a crossover study, with random effect for subject and fixed effects for study period and product.|Ratio calculated as Positive Control/Placebo|analyzed as log(EFU)||6.18|4.37|<0.001
72598802|NCT06010732|144728433|SUPERIORITY||Mean Difference (Final Values)|3.1||||0.272|TWO_SIDED|95.0|-2.5|8.6||No alpha-level adjustments for multiple comparisons adjustments were applied.|Mixed Models Analysis|Analysis of variance models (ANOVA) suitable for a crossover study, with random effect for subject and fixed effects for study period and product.|Difference calculated as Test-Positive Control|||8.6|-2.5|0.272
72598803|NCT06010732|144728433|SUPERIORITY||Mean Difference (Final Values)|34.8|||<|0.001|TWO_SIDED|95.0|29.3|40.3||No alpha-level adjustments for multiple comparisons adjustments were applied.|Mixed Models Analysis|Analysis of variance models (ANOVA) suitable for a crossover study, with random effect for subject and fixed effects for study period and product.|Difference calculated as Test-Placebo|||40.3|29.3|<0.001
72598804|NCT06010732|144728433|SUPERIORITY||Mean Difference (Final Values)|31.7|||<|0.001|TWO_SIDED|95.0|26.2|37.3||No alpha-level adjustments for multiple comparisons adjustments were applied.|Mixed Models Analysis|Analysis of variance models (ANOVA) suitable for a crossover study, with random effect for subject and fixed effects for study period and product.|Difference calculated as Positive Control-Placebo|||37.3|26.2|<0.001
72598805|NCT06010732|144728434|SUPERIORITY||Ratio of Means|1.11||||0.191|TWO_SIDED|95.0|0.93|1.32||No alpha-level adjustments for multiple comparisons adjustments were applied.|Mixed Models Analysis|Analysis of variance models (ANOVA) suitable for a crossover study, with random effect for subject and fixed effects for study period and product.|Ratio calculated as Test/Positive Control|analyzed as log(%CAR+100)||1.32|0.93|0.191
72598806|NCT06010732|144728434|SUPERIORITY||Ratio of Means|0.94||||0.003|TWO_SIDED|95.0|0.91|0.98||No alpha-level adjustments for multiple comparisons adjustments were applied.|Mixed Models Analysis|Analysis of variance models (ANOVA) suitable for a crossover study, with random effect for subject and fixed effects for study period and product.|Ratio calculated as Test/Placebo|analyzed as log(%CAR+100)||0.98|0.91|0.003
72598807|NCT06010732|144728434|SUPERIORITY||Ratio of Means|0.97||||0.092|TWO_SIDED|95.0|0.93|1.01||No alpha-level adjustments for multiple comparisons adjustments were applied.|Mixed Models Analysis|Analysis of variance models (ANOVA) suitable for a crossover study, with random effect for subject and fixed effects for study period and product.|Ratio calculated as Positive Control/Placebo|analyzed as log(%CAR+100)||1.01|0.93|0.092
72598808|NCT06010732|144728435|SUPERIORITY||Ratio of Means|1.01||||0.905|TWO_SIDED|95.0|0.9|1.13||No alpha-level adjustments for multiple comparisons adjustments were applied.|Mixed Models Analysis|Analysis of variance models (ANOVA) suitable for a crossover study, with random effect for subject and fixed effects for study period and product.|Ratio calculated as Test/Positive Control|analyzed as log(∆Z)||1.13|0.90|0.905
72598809|NCT06010732|144728435|SUPERIORITY||Ratio of Means|0.71|||<|0.001|TWO_SIDED|95.0|0.63|0.8||No alpha-level adjustments for multiple comparisons adjustments were applied.|Mixed Models Analysis|Analysis of variance models (ANOVA) suitable for a crossover study, with random effect for subject and fixed effects for study period and product.|Ratio calculated as Test/Placebo|analyzed as log(∆Z)||0.80|0.63|<0.001
72598810|NCT06010732|144728435|SUPERIORITY||Ratio of Means|0.7|||<|0.001|TWO_SIDED|95.0|0.63|0.79||No alpha-level adjustments for multiple comparisons adjustments were applied.|Mixed Models Analysis|Analysis of variance models (ANOVA) suitable for a crossover study, with random effect for subject and fixed effects for study period and product.|Ratio calculated as Positive Control/Placebo|analyzed as log(∆Z)||0.79|0.63|<0.001
72598811|NCT06010732|144728436|SUPERIORITY||Ratio of Means|0.98||||0.721|TWO_SIDED|95.0|0.88|1.09||No alpha-level adjustments for multiple comparisons adjustments were applied.|Mixed Models Analysis|Analysis of variance models (ANOVA) suitable for a crossover study, with random effect for subject and fixed effects for study period and product.|Ratio calculated as Test/Positive Control|analyzed as log(lesion depth)||1.09|0.88|0.721
72598812|NCT06010732|144728436|SUPERIORITY||Ratio of Means|0.75|||<|0.001|TWO_SIDED|95.0|0.68|0.84||No alpha-level adjustments for multiple comparisons adjustments were applied.|Mixed Models Analysis|Analysis of variance models (ANOVA) suitable for a crossover study, with random effect for subject and fixed effects for study period and product.|Ratio calculated as Test/Placebo|analyzed as log(lesion depth)||0.84|0.68|<0.001
72598813|NCT06010732|144728436|SUPERIORITY||Ratio of Means|0.77|||<|0.001|TWO_SIDED|95.0|0.69|0.86||No alpha-level adjustments for multiple comparisons adjustments were applied.|Mixed Models Analysis|Analysis of variance models (ANOVA) suitable for a crossover study, with random effect for subject and fixed effects for study period and product.|Ratio calculated as Positive Control/Placebo|analyzed as log(lesion depth)||0.86|0.69|<0.001
72415815|NCT01680328|144342431|SUPERIORITY_OR_OTHER||Least Square Mean Difference|1.1||||||95.0|-0.1|2.3||||||Backflow (absorbed amount of liquid 2 minutes (±30 sec) after the injection with filter-paper rated according to the liquid scale) was analysed using a mixed ANOVA approach and calculated as the mean differences in backflow in the abdomen at different volume and speed combinations.||2.3|-0.1|
72598814|NCT06010732|144728437|SUPERIORITY||Mean Difference (Final Values)|-0.56||||0.647|TWO_SIDED|95.0|-2.95|1.84||No alpha-level adjustments for multiple comparisons adjustments were applied.|Mixed Models Analysis|Analysis of variance models (ANOVA) suitable for a crossover study, with random effect for subject and fixed effects for study period and product.|Difference calculated as Test-Positive Control|||1.84|-2.95|0.647
72598815|NCT06010732|144728437|SUPERIORITY||Mean Difference (Final Values)|6.35|||<|0.001|TWO_SIDED|95.0|3.95|8.75||No alpha-level adjustments for multiple comparisons adjustments were applied.|Mixed Models Analysis|Analysis of variance models (ANOVA) suitable for a crossover study, with random effect for subject and fixed effects for study period and product.|Difference calculated as Test-Placebo|||8.75|3.95|<0.001
72598816|NCT06010732|144728437|SUPERIORITY||Mean Difference (Final Values)|6.9|||<|0.001|TWO_SIDED|95.0|4.49|9.31||No alpha-level adjustments for multiple comparisons adjustments were applied.|Mixed Models Analysis|Analysis of variance models (ANOVA) suitable for a crossover study, with random effect for subject and fixed effects for study period and product.|Difference calculated as Positive Control-Placebo|||9.31|4.49|<0.001
72415816|NCT01680328|144342431|SUPERIORITY_OR_OTHER||Least Square Mean Difference|2.3||||||95.0|1.0|3.5||||||Backflow (absorbed amount of liquid 2 minutes (±30 sec) after the injection with filter-paper rated according to the liquid scale) was analysed using a mixed ANOVA approach and calculated as the mean differences in backflow in the abdomen at different volume and speed combinations.||3.5|1.0|
72415817|NCT01680328|144342431|SUPERIORITY_OR_OTHER||Least Square Mean Difference|1.4||||||95.0|0.2|2.6||||||Backflow (absorbed amount of liquid 2 minutes (±30 sec) after the injection with filter-paper rated according to the liquid scale) was analysed using a mixed ANOVA approach and calculated as the mean differences in backflow in the abdomen at different volume and speed combinations.||2.6|0.2|
72415818|NCT01680328|144342431|SUPERIORITY_OR_OTHER||Least Square Mean Difference|0.6||||||95.0|-0.6|1.8||||||Backflow (absorbed amount of liquid 2 minutes (±30 sec) after the injection with filter-paper rated according to the liquid scale) was analysed using a mixed ANOVA approach and calculated as the mean differences in backflow in the abdomen at different volume and speed combinations.||1.8|-0.6|
72415819|NCT01680328|144342432|SUPERIORITY_OR_OTHER||Least Square Mean Difference|0.3||||||95.0|-0.9|1.5||||||Backflow (absorbed amount of liquid 2 minutes (±30 sec) after the injection with filter-paper rated according to the liquid scale) was analysed using a mixed ANOVA approach and calculated as the mean differences in backflow in the thigh at different volume and speed combinations.||1.5|-0.9|
72598817|NCT04401202|144728438|SUPERIORITY|||||||0.001|||||||Chi-squared|||||||0.001
72598818|NCT01119846|144728471|SUPERIORITY_OR_OTHER||Slope|0.5782|||||TWO_SIDED|90.0|0.523|0.6335|||||Dose Proportionality for GSK1292263 Using the Power Model.|||0.6335|0.5230|
72598819|NCT01119846|144728473|SUPERIORITY_OR_OTHER||Slope|0.5828|||||TWO_SIDED|90.0|0.5282|0.6375|||||Dose Proportionality for GSK1292263 Using the Power Model for AUC0-24.|||0.6375|0.5282|
72598820|NCT01119846|144728473|SUPERIORITY_OR_OTHER||Slope|0.5808|||||TWO_SIDED|90.0|0.5325|0.6291|||||Dose Proportionality for GSK1292263 Using the Power Model for AUC0-last.|||0.6291|0.5325|
72598821|NCT01119846|144728488|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.036|||||TWO_SIDED|95.0|-1.17|1.1||||||||1.10|-1.17|
72415820|NCT01680328|144342432|SUPERIORITY_OR_OTHER||Least Square Mean Difference|0.8||||||95.0|-0.4|2.1||||||Backflow (absorbed amount of liquid 2 minutes (±30 sec) after the injection with filter-paper rated according to the liquid scale) was analysed using a mixed ANOVA approach and calculated as the mean differences in backflow in the thigh at different volume and speed combinations.||2.1|-0.4|
72415821|NCT01680328|144342432|SUPERIORITY_OR_OTHER||Least Square Mean Difference|1.6||||||95.0|0.3|2.8||||||Backflow (absorbed amount of liquid 2 minutes (±30 sec) after the injection with filter-paper rated according to the liquid scale) was analysed using a mixed ANOVA approach and calculated as the mean differences in backflow in the thigh at different volume and speed combinations.||2.8|0.3|
72415822|NCT01680328|144342432|SUPERIORITY_OR_OTHER||Least Square Mean Difference|4.9||||||95.0|3.7|6.1||||||Backflow (absorbed amount of liquid 2 minutes (±30 sec) after the injection with filter-paper rated according to the liquid scale) was analysed using a mixed ANOVA approach and calculated as the mean differences in backflow in the thigh at different volume and speed combinations.||6.1|3.7|
72598822|NCT01119846|144728488|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.225|||||TWO_SIDED|95.0|-0.9|1.35||||||||1.35|-0.90|
72598823|NCT01119846|144728488|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.046|||||TWO_SIDED|95.0|-1.1|1.19||||||||1.19|-1.10|
72598824|NCT01119846|144728488|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.679|||||TWO_SIDED|95.0|-1.8|0.45||||||||0.45|-1.80|
72598825|NCT01119846|144728489|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.265|||||TWO_SIDED|95.0|-1.8|2.33|||||Comparison of AUC(0-24)|||2.33|-1.80|
72598826|NCT01119846|144728489|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.614|||||TWO_SIDED|95.0|-1.53|2.76|||||Comparison of AUC(0-24)|||2.76|-1.53|
72598827|NCT01119846|144728489|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.451|||||TWO_SIDED|95.0|-1.64|2.54|||||Comparison of AUC(0-24)|||2.54|-1.64|
72598828|NCT01119846|144728489|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.469|||||TWO_SIDED|95.0|-1.39|2.33|||||Comparison of AUC(0-24)|||2.33|-1.39|
72598829|NCT01119846|144728489|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.29|||||TWO_SIDED|95.0|-2.53|1.95|||||Comparison of AUC(0-13)|||1.95|-2.53|
72598830|NCT01119846|144728489|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.026|||||TWO_SIDED|95.0|-2.35|2.3|||||Comparison of AUC(0-13)|||2.30|-2.35|
72598831|NCT01119846|144728489|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.163|||||TWO_SIDED|95.0|-2.48|2.15|||||Comparison of AUC(0-13)|||2.15|-2.48|
72598832|NCT01119846|144728489|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.167|||||TWO_SIDED|95.0|-1.88|2.21|||||Comparison of AUC(0-13)|||2.21|-1.88|
72598833|NCT01119846|144728489|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.352|||||TWO_SIDED|95.0|-1.58|0.87|||||Comparison of iAUC(0-13)|||0.87|-1.58|
72598834|NCT01119846|144728489|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.136|||||TWO_SIDED|95.0|-1.41|1.13|||||Comparison of iAUC(0-13)|||1.13|-1.41|
72598835|NCT01119846|144728489|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.091|||||TWO_SIDED|95.0|-1.36|1.18|||||Comparison of iAUC(0-13)|||1.18|-1.36|
72598836|NCT01119846|144728489|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.206|||||TWO_SIDED|95.0|-1.33|0.91|||||Comparison of iAUC(0-13)|||0.91|-1.33|
72598837|NCT01119846|144728489|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.499|||||TWO_SIDED|95.0|-1.68|0.68|||||Comparison of iAUC(0-24)|||0.68|-1.68|
72598838|NCT01119846|144728489|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.017|||||TWO_SIDED|95.0|-1.24|1.21|||||Comparison of iAUC(0-24)|||1.21|-1.24|
72598839|NCT01119846|144728489|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.247|||||TWO_SIDED|95.0|-1.44|0.95|||||Comparison of iAUC(0-24)|||0.95|-1.44|
72598840|NCT01119846|144728489|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.661|||||TWO_SIDED|95.0|-1.72|0.4|||||Comparison of iAUC(0-24)|||0.40|-1.72|
72598841|NCT01119846|144728490|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-49.898|||||TWO_SIDED|95.0|-479.74|379.94|||||Comparison of C-peptide, AUC 0-12|||379.94|-479.74|
72598842|NCT01119846|144728490|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-61.642|||||TWO_SIDED|95.0|-507.32|384.04|||||Comparison of C-peptide, AUC 0-12|||384.04|-507.32|
72598843|NCT01119846|144728490|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-85.849|||||TWO_SIDED|95.0|-530.07|358.37|||||Comparison of C-peptide, AUC 0-12|||358.37|-530.07|
72598844|NCT01119846|144728490|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-101.422|||||TWO_SIDED|95.0|-494.09|291.25|||||Comparison of C-peptide, AUC 0-12|||291.25|-494.09|
72598845|NCT01119846|144728490|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-39.239|||||TWO_SIDED|95.0|-340.32|261.85|||||Comparison of C-peptide, iAUC 0-12|||261.85|-340.32|
72598846|NCT01119846|144728490|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-117.435|||||TWO_SIDED|95.0|-429.61|194.74|||||Comparison of C-peptide, iAUC 0-12|||194.74|-429.61|
72598847|NCT01119846|144728490|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-121.982|||||TWO_SIDED|95.0|-433.14|189.18|||||Comparison of C-peptide, iAUC 0-12|||189.18|-433.14|
72598848|NCT01119846|144728490|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-81.016|||||TWO_SIDED|95.0|-356.07|194.03|||||Comparison of C-peptide, iAUC 0-12|||194.03|-356.07|
72598849|NCT01119846|144728490|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.812|||||TWO_SIDED|95.0|-8.08|13.7|||||Comparison of GIP total, AUC 0-12|||13.70|-8.08|
72598850|NCT01119846|144728490|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.023|||||TWO_SIDED|95.0|-8.27|14.32|||||Comparison of GIP total, AUC 0-12|||14.32|-8.27|
72598851|NCT01119846|144728490|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.483|||||TWO_SIDED|95.0|0.23|22.74|||||Comparison of GIP total, AUC 0-12|||22.74|0.23|
72598852|NCT01119846|144728490|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.093|||||TWO_SIDED|95.0|-17.04|2.86|||||Comparison of GIP total, AUC 0-12|||2.86|-17.04|
72598853|NCT01119846|144728490|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.5|||||TWO_SIDED|95.0|-7.28|12.28|||||Comparison of GIP total, iAUC 0-12|||12.28|-7.28|
72598854|NCT01119846|144728490|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.526|||||TWO_SIDED|95.0|-6.61|13.67|||||Comparison of GIP total, iAUC 0-12|||13.67|-6.61|
72598855|NCT01119846|144728490|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.934|||||TWO_SIDED|95.0|-2.17|18.04|||||Comparison of GIP total, iAUC 0-12|||18.04|-2.17|
72598856|NCT01119846|144728490|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.055|||||TWO_SIDED|95.0|-15.99|1.88|||||Comparison of GIP total, iAUC 0-12|||1.88|-15.99|
72598857|NCT01119846|144728490|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.018|||||TWO_SIDED|95.0|-0.79|0.76|||||Comparison of GLP-1 active, AUC 0-12|||0.76|-0.79|
72598858|NCT01119846|144728490|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.022|||||TWO_SIDED|95.0|-0.78|0.82|||||Comparison of GLP-1 active, AUC 0-12|||0.82|-0.78|
72598859|NCT01119846|144728490|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.039|||||TWO_SIDED|95.0|-0.78|0.85|||||Comparison of GLP-1 active, AUC 0-12|||0.85|-0.78|
72598860|NCT01119846|144728490|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.454|||||TWO_SIDED|95.0|2.74|4.17|||||Comparison of GLP-1 active, AUC 0-12|||4.17|2.74|
72598861|NCT01119846|144728490|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.015|||||TWO_SIDED|95.0|-0.78|0.75|||||Comparison of GLP-1 active, iAUC 0-12|||0.75|-0.78|
72598862|NCT01119846|144728490|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.006|||||TWO_SIDED|95.0|-0.79|0.8|||||Comparison of GLP-1 active, iAUC 0-12|||0.80|-0.79|
72598863|NCT01119846|144728490|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.018|||||TWO_SIDED|95.0|-0.79|0.83|||||Comparison of GLP-1 active, iAUC 0-12|||0.83|-0.79|
72598864|NCT01119846|144728490|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.399|||||TWO_SIDED|95.0|2.69|4.11|||||Comparison of GLP-1 active, iAUC 0-12|||4.11|2.69|
72598865|NCT01119846|144728490|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.052|||||TWO_SIDED|95.0|-2.06|2.17|||||Comparison of GLP-1 total, AUC 0-12|||2.17|-2.06|
72598866|NCT01119846|144728490|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.223|||||TWO_SIDED|95.0|-1.97|2.42|||||Comparison of GLP-1 total, AUC 0-12|||2.42|-1.97|
72598867|NCT01119846|144728490|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.835|||||TWO_SIDED|95.0|-0.35|4.02|||||Comparison of GLP-1 total, AUC 0-12|||4.02|-0.35|
72598868|NCT01119846|144728490|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.629|||||TWO_SIDED|95.0|-3.56|0.3|||||Comparison of GLP-1 total, AUC 0-12|||0.30|-3.56|
72598869|NCT01119846|144728490|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.078|||||TWO_SIDED|95.0|-1.7|1.86|||||Comparison of GLP-1 total, iAUC 0-12|||1.86|-1.70|
72598870|NCT01119846|144728490|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.286|||||TWO_SIDED|95.0|-1.56|2.13|||||Comparison of GLP-1 total, iAUC 0-12|||2.13|-1.56|
72598871|NCT01119846|144728490|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.764|||||TWO_SIDED|95.0|-1.08|2.6|||||Comparison of GLP-1 total, iAUC 0-12|||2.60|-1.08|
72598872|NCT01119846|144728490|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.336|||||TWO_SIDED|95.0|-2.96|0.29|||||Comparison of GLP-1 total, iAUC 0-12|||0.29|-2.96|
72598873|NCT01119846|144728490|SUPERIORITY||Mean Difference (Final Values)|0.962|||||TWO_SIDED|95.0|-4.26|6.18|||||Comparison of Glucagon, AUC 0-12|||6.18|-4.26|
72598874|NCT01119846|144728490|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.067|||||TWO_SIDED|95.0|-2.56|8.69|||||Comparison of Glucagon, AUC 0-12|||8.69|-2.56|
72598875|NCT01119846|144728490|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.517|||||TWO_SIDED|95.0|-2.98|8.01|||||Comparison of Glucagon, AUC 0-12|||8.01|-2.98|
72598876|NCT01119846|144728490|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.714|||||TWO_SIDED|95.0|-5.56|4.13|||||Comparison of Glucagon, AUC 0-12|||4.13|-5.56|
72598877|NCT01119846|144728490|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.866|||||TWO_SIDED|95.0|-6.4|0.67|||||Comparison of Glucagon, iAUC 0-12|||0.67|-6.40|
72598878|NCT01119846|144728490|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.865|||||TWO_SIDED|95.0|-4.68|2.95|||||Comparison of Glucagon, iAUC 0-12|||2.95|-4.68|
72598879|NCT01119846|144728490|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.436|||||TWO_SIDED|95.0|-4.16|3.29|||||Comparison of Glucagon, iAUC 0-12|||3.29|-4.16|
72598880|NCT01119846|144728490|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.573|||||TWO_SIDED|95.0|-4.86|1.71|||||Comparison of Glucagon, iAUC 0-12|||1.71|-4.86|
72598881|NCT01119846|144728490|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-24.74|||||TWO_SIDED|95.0|-168.38|118.9|||||Comparison of Insulin, AUC 0-13|||118.90|-168.38|
72598882|NCT01119846|144728490|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.229|||||TWO_SIDED|95.0|-161.16|136.7|||||Comparison of Insulin, AUC 0-13|||136.70|-161.16|
72598883|NCT01119846|144728490|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.628|||||TWO_SIDED|95.0|-158.07|138.81|||||Comparison of Insulin, AUC 0-13|||138.81|-158.07|
72598884|NCT01119846|144728490|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-66.936|||||TWO_SIDED|95.0|-198.15|64.28|||||Comparison of Insulin, AUC 0-13|||64.28|-198.15|
72598885|NCT01119846|144728490|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-36.042|||||TWO_SIDED|95.0|-150.57|78.48|||||Comparison of Insulin, iAUC 0-13|||78.48|-150.57|
72598886|NCT01119846|144728490|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-22.525|||||TWO_SIDED|95.0|-141.27|96.22|||||Comparison of Insulin, iAUC 0-13|||96.22|-141.27|
72598887|NCT01119846|144728490|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-22.0|||||TWO_SIDED|95.0|-140.36|96.36|||||Comparison of Insulin, iAUC 0-13|||96.36|-140.36|
72598888|NCT01119846|144728490|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-66.324|||||TWO_SIDED|95.0|-170.95|38.3|||||Comparison of Insulin, iAUC 0-13|||38.30|-170.95|
72598889|NCT01119846|144728490|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.982|||||TWO_SIDED|95.0|-2.66|14.62|||||Comparison of PYY total, AUC 0-12|||14.62|-2.66|
72598890|NCT01119846|144728490|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.908|||||TWO_SIDED|95.0|-0.05|17.86|||||Comparison of PYY total, AUC 0-12|||17.86|-0.05|
72598891|NCT01119846|144728490|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.317|||||TWO_SIDED|95.0|5.39|23.24|||||Comparison of PYY total, AUC 0-12|||23.24|5.39|
72598892|NCT01119846|144728490|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.44|||||TWO_SIDED|95.0|-13.33|2.45|||||Comparison of PYY total, AUC 0-12|||2.45|-13.33|
72598893|NCT01119846|144728490|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.999|||||TWO_SIDED|95.0|-1.87|11.87|||||Comparison of PYY total, iAUC 0-12|||11.87|-1.87|
72598894|NCT01119846|144728490|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.909|||||TWO_SIDED|95.0|-0.22|14.03|||||Comparison of PYY total, iAUC 0-12|||14.03|-0.22|
72598895|NCT01119846|144728490|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.036|||||TWO_SIDED|95.0|1.93|16.14|||||Comparison of PYY total, iAUC 0-12|||16.14|1.93|
72598896|NCT01119846|144728490|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.39|||||TWO_SIDED|95.0|-12.67|-0.11|||||Comparison of PYY total, iAUC 0-12|||-0.11|-12.67|
72598897|NCT01119846|144728491|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.564|||||TWO_SIDED|95.0|-2.69|1.56|||||Comparison of AUC 0-3|||1.56|-2.69|
72598898|NCT01119846|144728491|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.846|||||TWO_SIDED|95.0|-3.05|1.36|||||Comparison of AUC 0-3|||1.36|-3.05|
72598899|NCT01119846|144728491|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.175|||||TWO_SIDED|95.0|-3.37|1.02|||||Comparison of AUC 0-3|||1.02|-3.37|
72598900|NCT01119846|144728491|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.617|||||TWO_SIDED|95.0|-2.56|1.33|||||Comparison of AUC 0-3|||1.33|-2.56|
72598901|NCT01119846|144728491|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.626|||||TWO_SIDED|95.0|-1.64|0.39|||||Comparison of iAUC 0-3|||0.39|-1.64|
72598902|NCT01119846|144728491|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.956|||||TWO_SIDED|95.0|-2.01|0.09|||||Comparison of iAUC 0-3|||0.09|-2.01|
72598903|NCT01119846|144728491|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.103|||||TWO_SIDED|95.0|-2.15|-0.06|||||Comparison of iAUC 0-3|||-0.06|-2.15|
72598904|NCT01119846|144728491|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.99|||||TWO_SIDED|95.0|-1.91|-0.07|||||Comparison of iAUC 0-3|||-0.07|-1.91|
72598905|NCT01119846|144728492|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|152.962|||||TWO_SIDED|95.0|-200.57|506.49|||||Comparison of C-peptide, AUC 0-2|||506.49|-200.57|
72598906|NCT01119846|144728492|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|113.866|||||TWO_SIDED|95.0|-252.69|480.42|||||Comparison of C-peptide, AUC 0-2|||480.42|-252.69|
72598907|NCT01119846|144728492|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|114.474|||||TWO_SIDED|95.0|-250.89|479.83|||||Comparison of C-peptide, AUC 0-2|||479.83|-250.89|
72598908|NCT01119846|144728492|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|136.638|||||TWO_SIDED|95.0|-186.32|459.6|||||Comparison of C-peptide, AUC 0-2|||459.60|-186.32|
72598909|NCT01119846|144728492|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|163.622|||||TWO_SIDED|95.0|-127.31|454.55|||||Comparison of C-peptide, iAUC 0-2|||454.55|-127.31|
72598910|NCT01119846|144728492|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|58.074|||||TWO_SIDED|95.0|-243.57|359.72|||||Comparison of C-peptide, iAUC 0-2|||359.72|-243.57|
72598911|NCT01119846|144728492|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|78.341|||||TWO_SIDED|95.0|-222.32|379.0|||||Comparison of C-peptide, iAUC 0-2|||379.00|-222.32|
72598912|NCT01119846|144728492|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|157.044|||||TWO_SIDED|95.0|-108.73|422.82|||||Comparison of C-peptide, iAUC 0-2|||422.82|-108.73|
72598913|NCT01119846|144728492|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.539|||||TWO_SIDED|95.0|-4.79|17.87|||||Comparison of GIP total, AUC 0-2|||17.87|-4.79|
72598914|NCT01119846|144728492|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.095|||||TWO_SIDED|95.0|-7.65|15.84|||||Comparison of GIP total, AUC 0-2|||15.84|-7.65|
72598915|NCT01119846|144728492|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.033|||||TWO_SIDED|95.0|1.33|24.74|||||Comparison of GIP total, AUC 0-2|||24.74|1.33|
72598916|NCT01119846|144728492|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.824|||||TWO_SIDED|95.0|-13.17|7.52|||||Comparison of GIP total, AUC 0-2|||7.52|-13.17|
72598917|NCT01119846|144728492|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.227|||||TWO_SIDED|95.0|-3.47|15.93|||||Comparison of GIP total, iAUC 0-2|||15.93|-3.47|
72598918|NCT01119846|144728492|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.598|||||TWO_SIDED|95.0|-5.46|14.65|||||Comparison of GIP total, iAUC 0-2|||14.65|-5.46|
72598919|NCT01119846|144728492|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.484|||||TWO_SIDED|95.0|-0.54|19.51|||||Comparison of GIP total, iAUC 0-2|||19.51|-0.54|
72598920|NCT01119846|144728492|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.786|||||TWO_SIDED|95.0|-11.65|6.08|||||Comparison of GIP total, iAUC 0-2|||6.08|-11.65|
72598921|NCT01119846|144728492|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.066|||||TWO_SIDED|95.0|-0.38|0.52|||||Comparison of GLP-1 active, AUC 0-2|||0.52|-0.38|
72598922|NCT01119846|144728492|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.256|||||TWO_SIDED|95.0|-0.21|0.72|||||Comparison of GLP-1 active, AUC 0-2|||0.72|-0.21|
72598923|NCT01119846|144728492|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.048|||||TWO_SIDED|95.0|-0.42|0.51|||||Comparison of GLP-1 active, AUC 0-2|||0.51|-0.42|
72598924|NCT01119846|144728492|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.694|||||TWO_SIDED|95.0|2.28|3.11|||||Comparison of GLP-1 active, AUC 0-2|||3.11|2.28|
72598925|NCT01119846|144728492|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.071|||||TWO_SIDED|95.0|-0.36|0.5|||||Comparison of GLP-1 active, iAUC 0-2|||0.50|-0.36|
72598926|NCT01119846|144728492|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.243|||||TWO_SIDED|95.0|-0.2|0.69|||||Comparison of GLP-1 active, iAUC 0-2|||0.69|-0.20|
72598927|NCT01119846|144728492|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.031|||||TWO_SIDED|95.0|-0.41|0.47|||||Comparison of GLP-1 active, iAUC 0-2|||0.47|-0.41|
72598928|NCT01119846|144728492|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.643|||||TWO_SIDED|95.0|2.25|3.04|||||Comparison of GLP-1 active, iAUC 0-2|||3.04|2.25|
72598929|NCT01119846|144728492|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.055|||||TWO_SIDED|95.0|-1.44|1.55|||||Comparison of GLP-1 total, AUC 0-2|||1.55|-1.44|
72598930|NCT01119846|144728492|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.268|||||TWO_SIDED|95.0|-1.28|1.82|||||Comparison of GLP-1 total, AUC 0-2|||1.82|-1.28|
72598931|NCT01119846|144728492|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.894|||||TWO_SIDED|95.0|-0.65|2.44|||||Comparison of GLP-1 total, AUC 0-2|||2.44|-0.65|
72415823|NCT01680328|144342432|SUPERIORITY_OR_OTHER||Least Square Mean Difference|1.7||||||95.0|0.5|2.9||||||Backflow (absorbed amount of liquid 2 minutes (±30 sec) after the injection with filter-paper rated according to the liquid scale) was analysed using a mixed ANOVA approach and calculated as the mean differences in backflow in the thigh at different volume and speed combinations.||2.9|0.5|
72598932|NCT01119846|144728492|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.483|||||TWO_SIDED|95.0|-2.85|-0.12|||||Comparison of GLP-1 total, AUC 0-2|||-0.12|-2.85|
72598933|NCT01119846|144728492|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.081|||||TWO_SIDED|95.0|-1.18|1.34|||||Comparison of GLP-1 total, iAUC 0-2|||1.34|-1.18|
72598934|NCT01119846|144728492|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.331|||||TWO_SIDED|95.0|-0.97|1.63|||||Comparison of GLP-1 total, iAUC 0-2|||1.63|-0.97|
72598935|NCT01119846|144728492|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.177|||||TWO_SIDED|95.0|-1.48|1.12|||||Comparison of GLP-1 total, iAUC 0-2|||1.12|-1.48|
72598936|NCT01119846|144728492|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-1.19|||||TWO_SIDED|95.0|-2.34|-0.04|||||Comparison of GLP-1 total, iAUC 0-2|||-0.04|-2.34|
72598937|NCT01119846|144728492|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.235|||||TWO_SIDED|95.0|-1.51|3.98|||||Comparison of Glucagon, AUC 0-2|||3.98|-1.51|
72598938|NCT01119846|144728492|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.877|||||TWO_SIDED|95.0|0.04|5.71|||||Comparison of Glucagon, AUC 0-2|||5.71|0.04|
72598939|NCT01119846|144728492|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.473|||||TWO_SIDED|95.0|-1.21|4.16|||||Comparison of Glucagon, AUC 0-2|||4.16|-1.21|
72598940|NCT01119846|144728492|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.274|||||TWO_SIDED|95.0|-2.2|2.74|||||Comparison of Glucagon, AUC 0-2|||2.74|-2.20|
72598941|NCT01119846|144728492|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.177|||||TWO_SIDED|95.0|-4.92|0.56|||||Comparison of Glucagon, iAUC 0-2|||0.56|-4.92|
72598942|NCT01119846|144728492|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.909|||||TWO_SIDED|95.0|-4.74|0.93|||||Comparison of Glucagon, iAUC 0-2|||0.93|-4.74|
72598943|NCT01119846|144728492|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.053|||||TWO_SIDED|95.0|-3.74|1.63|||||Comparison of Glucagon, iAUC 0-2|||1.63|-3.74|
72598944|NCT01119846|144728492|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.249|||||TWO_SIDED|95.0|-3.72|1.22|||||Comparison of Glucagon, iAUC 0-2|||1.22|-3.72|
72598945|NCT01119846|144728492|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.389|||||TWO_SIDED|95.0|-95.82|122.59|||||Comparison of Insulin, AUC 0-3|||122.59|-95.82|
72598946|NCT01119846|144728492|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.98|||||TWO_SIDED|95.0|-103.25|123.21|||||Comparison of Insulin, AUC 0-3|||123.21|-103.25|
72598947|NCT01119846|144728492|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|32.426|||||TWO_SIDED|95.0|-80.43|145.28|||||Comparison of Insulin, AUC 0-3|||145.28|-80.43|
72598948|NCT01119846|144728492|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|22.994|||||TWO_SIDED|95.0|-76.77|122.76|||||Comparison of Insulin, AUC 0-3|||122.76|-76.77|
72598949|NCT01119846|144728492|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.088|||||TWO_SIDED|95.0|-86.79|90.97|||||Comparison of Insulin, iAUC 0-3|||90.97|-86.79|
72598950|NCT01119846|144728492|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.316|||||TWO_SIDED|95.0|-92.47|91.84|||||Comparison of Insulin, iAUC 0-3|||91.84|-92.47|
72598951|NCT01119846|144728492|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|20.053|||||TWO_SIDED|95.0|-71.8|111.91|||||Comparison of Insulin, iAUC 0-3|||111.91|-71.80|
72598952|NCT01119846|144728492|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|23.606|||||TWO_SIDED|95.0|-57.59|104.8|||||Comparison of Insulin, iAUC 0-3|||104.80|-57.59|
72598953|NCT01119846|144728492|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.506|||||TWO_SIDED|95.0|-3.13|10.14|||||Comparison of PYY total, AUC 0-2|||10.14|-3.13|
72598954|NCT01119846|144728492|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.295|||||TWO_SIDED|95.0|0.41|14.18|||||Comparison of PYY total, AUC 0-2|||14.18|0.41|
72598955|NCT01119846|144728492|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.006|||||TWO_SIDED|95.0|0.15|13.87|||||Comparison of PYY total, AUC 0-2|||13.87|0.15|
72598956|NCT01119846|144728492|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.555|||||TWO_SIDED|95.0|-8.62|3.51|||||Comparison of PYY total, AUC 0-2|||3.51|-8.62|
72598957|NCT01119846|144728492|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.523|||||TWO_SIDED|95.0|-2.13|7.17|||||Comparison of PYY total, iAUC 0-2|||7.17|-2.13|
72598958|NCT01119846|144728492|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.296|||||TWO_SIDED|95.0|0.47|10.12|||||Comparison of PYY total, iAUC 0-2|||10.12|0.47|
72598959|NCT01119846|144728492|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.726|||||TWO_SIDED|95.0|-3.08|6.53|||||Comparison of PYY total, iAUC 0-2|||6.53|-3.08|
72598960|NCT01119846|144728492|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.506|||||TWO_SIDED|95.0|-7.75|0.74|||||Comparison of PYY total, iAUC 0-2|||0.74|-7.75|
72598961|NCT01119846|144728493|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.241|||||TWO_SIDED|95.0|-0.84|1.32||||||||1.32|-0.84|
72598962|NCT01119846|144728493|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.523|||||TWO_SIDED|95.0|-0.6|1.64||||||||1.64|-0.60|
72598963|NCT01119846|144728493|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.053|||||TWO_SIDED|95.0|-1.17|1.06||||||||1.06|-1.17|
72598964|NCT01119846|144728493|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.172|||||TWO_SIDED|95.0|-0.81|1.16||||||||1.16|-0.81|
72415824|NCT00857207|144342457|SUPERIORITY||Mean Difference (Final Values)|-3.95|STANDARD_ERROR_OF_MEAN|1.14||0.0004|TWO_SIDED|95.0|||||Regression, Linear|dependent variable: post-treatment outcome; independent variables:pre-treatment measurement and group indicator.||Linear regression of change of cTOL time to first move in GMT versus BHW group||||0.0004
72598965|NCT01119846|144728494|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01|||||TWO_SIDED|95.0|-0.08|0.06|||||Comparison of G/I ratio|||0.06|-0.08|
72598966|NCT01119846|144728494|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.002|||||TWO_SIDED|95.0|-0.07|0.07|||||Comparison of G/I ratio|||0.07|-0.07|
72598967|NCT01119846|144728494|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.003|||||TWO_SIDED|95.0|-0.07|0.07|||||Comparison of G/I ratio|||0.07|-0.07|
72598968|NCT01119846|144728494|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.017|||||TWO_SIDED|95.0|-0.04|0.08|||||Comparison of G/I ratio|||0.08|-0.04|
72598969|NCT01119846|144728494|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.269|||||TWO_SIDED|95.0|-8.31|12.85|||||Comparison of I/G ratio|||12.85|-8.31|
72598970|NCT01119846|144728494|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.959|||||TWO_SIDED|95.0|-8.01|13.93|||||Comparison of I/G ratio|||13.93|-8.01|
72598971|NCT01119846|144728494|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.053|||||TWO_SIDED|95.0|-4.88|16.99|||||Comparison of I/G ratio|||16.99|-4.88|
72415825|NCT00857207|144342457|SUPERIORITY||Mean Difference (Final Values)|-2.92|STANDARD_DEVIATION|3.55||0.012|TWO_SIDED|95.0|||||t-test, 2 sided|||total time will significantly improve 10 weeks from post||||0.012
72598972|NCT01119846|144728494|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.017|||||TWO_SIDED|95.0|-5.65|13.68|||||Comparison of I/G ratio|||13.68|-5.65|
72598973|NCT01119846|144728495|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.025|||||TWO_SIDED|95.0|-0.28|0.22|||||Comparison of insulin glucose index|||0.22|-0.28|
72598974|NCT01119846|144728495|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.055|||||TWO_SIDED|95.0|-0.2|0.31|||||Comparison of insulin glucose index|||0.31|-0.20|
72598975|NCT01119846|144728495|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.028|||||TWO_SIDED|95.0|-0.29|0.23|||||Comparison of insulin glucose index|||0.23|-0.29|
72598976|NCT01119846|144728495|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.041|||||TWO_SIDED|95.0|-0.27|0.19|||||Comparison of insulin glucose index|||0.19|-0.27|
72598977|NCT01119846|144728496|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.346|||||TWO_SIDED|95.0|-2.06|1.37||||||||1.37|-2.06|
72598978|NCT01119846|144728496|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.045|||||TWO_SIDED|95.0|-1.82|1.73||||||||1.73|-1.82|
72415826|NCT00857207|144342457|SUPERIORITY||Mean Difference (Final Values)|0.02|STANDARD_DEVIATION|2.04||0.98|TWO_SIDED|95.0|||||t-test, 2 sided|||Time to first move will significantly increase at 10 weeks from baseline to indicate better planning||||0.98
72598979|NCT01119846|144728496|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.388|||||TWO_SIDED|95.0|-2.16|1.38||||||||1.38|-2.16|
72598980|NCT01119846|144728496|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.133|||||TWO_SIDED|95.0|-1.43|1.7||||||||1.70|-1.43|
72598981|NCT01119846|144728497|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.523|||||TWO_SIDED|95.0|-3.04|2.0|||||Comparison of Day 7, 1 Hour|||2.00|-3.04|
72598982|NCT01119846|144728497|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.569|||||TWO_SIDED|95.0|-3.07|1.94|||||Comparison of Day 7, 1 Hour|||1.94|-3.07|
72598983|NCT01119846|144728497|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.064|||||TWO_SIDED|95.0|-0.45|4.57|||||Comparison of Day 7, 1 Hour|||4.57|-0.45|
72598984|NCT01119846|144728497|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.316|||||TWO_SIDED|95.0|-2.19|2.82|||||Comparison of Day 7, 1 Hour|||2.82|-2.19|
72598985|NCT01119846|144728497|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.484|||||TWO_SIDED|95.0|-3.99|1.02|||||Comparison of Day 7, 1 Hour|||1.02|-3.99|
72415827|NCT00857207|144342458|SUPERIORITY||Mean Difference (Final Values)|2.64|STANDARD_DEVIATION|6.42||0.15|TWO_SIDED|95.0|||||t-test, 2 sided|||paired T-test, Behavioral Regulation Index will improve at week 10 from baseline||||0.15
72415828|NCT00857207|144342458|SUPERIORITY||Mean Difference (Final Values)|2.79|STANDARD_DEVIATION|8.4||0.24|TWO_SIDED|95.0|||||t-test, 2 sided|||paired t-test of Metacognitive Index, MI will improve at 10 weeks compared to baseline.||||0.24
72415829|NCT00857207|144342459|SUPERIORITY||Median Difference (Final Values)|0.03|STANDARD_DEVIATION|0.09||0.3|TWO_SIDED|95.0|||||t-test, 2 sided|||optimal moves will significantly increase at 10 weeks from baseline||||0.30
72415830|NCT01760239|144342460|SUPERIORITY||Odds Ratio (OR)|4.51|||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<.001
72598986|NCT01119846|144728497|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.795|||||TWO_SIDED|95.0|-3.27|1.68|||||Comparison of Day 7, 2 Hours|||1.68|-3.27|
72598987|NCT01119846|144728497|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.313|||||TWO_SIDED|95.0|-2.78|2.15|||||Comparison of Day 7, 2 Hours|||2.15|-2.78|
72415831|NCT01760239|144342461|SUPERIORITY||Odds Ratio (OR)|2.36||||0.046|TWO_SIDED||||||Mixed Models Analysis|||||||.046
72415832|NCT01760239|144342462|SUPERIORITY||Odds Ratio (OR)|5.13||||0.001|TWO_SIDED||||||Mixed Models Analysis|||||||.001
72415833|NCT03035292|144342464|SUPERIORITY||||||<|0.05||||||This value of \<0.05 is the calculated p value where the a priori threshold for statistical significance is considered to be p=0.05.|McNemar|||Sample size was based on a cataract prevalence of 20% in the enriched population and a predicted difference of 15% sensitivity and specificity between tests.||||<0.05
72415834|NCT03035292|144342466|SUPERIORITY||||||<|0.05||||||The calculated p value was \<0.05. A priori threshold for statistical significance is p=0.05|Fisher Exact|||Evidence of superiority of intervention 2 over intervention 1 requires a significant difference in specificity of the intervention 1 and 2 between ethnicity groups.||||<0.05
72598988|NCT01119846|144728497|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.441|||||TWO_SIDED|95.0|-0.03|4.91|||||Comparison of Day 7, 2 Hours|||4.91|-0.03|
72598989|NCT01119846|144728497|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.884|||||TWO_SIDED|95.0|-1.58|3.34|||||Comparison of Day 7, 2 Hours|||3.34|-1.58|
72598990|NCT01119846|144728497|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.222|||||TWO_SIDED|95.0|-3.69|1.24|||||Comparison of Day 7, 2 Hours|||1.24|-3.69|
72415835|NCT00440531|144342467|SUPERIORITY_OR_OTHER||single-group percentage|75.7||||||95.0|68.0|82.2||||||No hypothesis is being tested. The purpose of the primary analysis is to estimate the seroprotection rate (percentage of subjects with anti-HBs \>=10mIU/mL) in each group at 1 month post vaccination 3, among subjects who were seronegative at baseline.||82.20|68|
72415836|NCT00440531|144342467|SUPERIORITY_OR_OTHER||single-group percentage|68.0||||||95.0|59.8|75.5||||||No hypothesis is being tested. The purpose of the primary analysis is to estimate the seroprotection rate (percentage of subjects with anti-HBs \>=10mIU/mL) in each group at 1 month post vaccination 3, among subjects who were seronegative at baseline.||75.50|59.80|
72598991|NCT01119846|144728497|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.017|||||TWO_SIDED|95.0|-2.06|2.03|||||Comparison of Day 7, 4 Hours|||2.03|-2.06|
72415837|NCT00440531|144342468|SUPERIORITY_OR_OTHER||Single-Group Percentage|84.0||||||95.0|77.0|89.6||||||No hypothesis is being tested. The purpose of the secondary analysis is to estimate the seroprotection rate (percentage of subjects with anti-HBs \>=10mIU/mL) for ENGERIX-B™ at 1 month post vaccination 3, among subjects who were seronegative at baseline.||89.60|77|
72598992|NCT01119846|144728497|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.475|||||TWO_SIDED|95.0|-1.56|2.51|||||Comparison of Day 7, 4 Hours|||2.51|-1.56|
72598993|NCT01119846|144728497|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.512|||||TWO_SIDED|95.0|-0.53|3.55|||||Comparison of Day 7, 4 Hours|||3.55|-0.53|
72598994|NCT01119846|144728497|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.233|||||TWO_SIDED|95.0|-0.8|3.26|||||Comparison of Day 7, 4 Hours|||3.26|-0.80|
72598995|NCT01119846|144728497|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.011|||||TWO_SIDED|95.0|-3.05|1.02|||||Comparison of Day 7, 4 Hours|||1.02|-3.05|
72598996|NCT01119846|144728497|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.189|||||TWO_SIDED|95.0|-3.05|2.67|||||Comparison of Day 7, 6 Hours|||2.67|-3.05|
72415838|NCT00686166|144342478|SUPERIORITY_OR_OTHER|||||||0.18|TWO_SIDED||||||Exact binomal test|||||||0.18
72598997|NCT01119846|144728497|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.456|||||TWO_SIDED|95.0|-2.39|3.3|||||Comparison of Day 7, 6 Hours|||3.30|-2.39|
72598998|NCT01119846|144728497|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.706|||||TWO_SIDED|95.0|-0.14|5.56|||||Comparison of Day 7, 6 Hours|||5.56|-0.14|
72598999|NCT01119846|144728497|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.062|||||TWO_SIDED|95.0|-1.78|3.91|||||Comparison of Day 7, 6 Hours|||3.91|-1.78|
72599000|NCT01119846|144728497|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.708|||||TWO_SIDED|95.0|-5.55|0.14|||||Comparison of Day 7, 6 Hours|||0.14|-5.55|
72599001|NCT01119846|144728497|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.147|||||TWO_SIDED|95.0|-2.41|2.7|||||Comparison of Day 7, 10 Hours|||2.70|-2.41|
72599002|NCT01119846|144728497|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.452|||||TWO_SIDED|95.0|-2.09|2.99|||||Comparison of Day 7, 10 Hours|||2.99|-2.09|
72599003|NCT01119846|144728497|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.418|||||TWO_SIDED|95.0|-0.13|4.96|||||Comparison of Day 7, 10 Hours|||4.96|-0.13|
72599004|NCT01119846|144728497|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.063|||||TWO_SIDED|95.0|-1.47|3.6|||||Comparison of Day 7, 10 Hours|||3.60|-1.47|
72599005|NCT01119846|144728497|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.509|||||TWO_SIDED|95.0|-4.05|1.03|||||Comparison of Day 7, 10 Hours|||1.03|-4.05|
72599006|NCT01119846|144728497|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.3|||||TWO_SIDED|95.0|-4.2|1.6|||||Comparison of Day 7, 12 Hours|||1.60|-4.20|
72599007|NCT01119846|144728497|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.325|||||TWO_SIDED|95.0|-4.21|1.56|||||Comparison of Day 7, 12 Hours|||1.56|-4.21|
72599008|NCT01119846|144728497|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.0|||||TWO_SIDED|95.0|-1.89|3.89|||||Comparison of Day 7, 12 Hours|||3.89|-1.89|
72599009|NCT01119846|144728497|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.265|||||TWO_SIDED|95.0|-3.14|2.62|||||Comparison of Day 7, 12 Hours|||2.62|-3.14|
72599010|NCT01119846|144728497|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.516|||||TWO_SIDED|95.0|-3.4|2.37|||||Comparison of Day 7, 12 Hours|||2.37|-3.40|
72599011|NCT01119846|144728497|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.515|||||TWO_SIDED|95.0|-2.29|1.26|||||Comparison of Day 14, 24 Hours|||1.26|-2.29|
72415839|NCT03912259|144342489|SUPERIORITY||Difference in Percentage|22.0|||<|0.0001|TWO_SIDED|95.0|11.37|32.65||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|P-value was derived by the Cochran-Mantel-Haenszel test stratified by baseline disease severity (IGA=3 vs. IGA=4).||||32.65|11.37|<.0001
72599012|NCT01119846|144728497|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.225|||||TWO_SIDED|95.0|-1.99|1.55|||||Comparison of Day 14, 24 Hours|||1.55|-1.99|
72599013|NCT01119846|144728497|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.501|||||TWO_SIDED|95.0|-1.28|2.28|||||Comparison of Day 14, 24 Hours|||2.28|-1.28|
72415840|NCT02216123|144342517|OTHER||Mean Difference (Final Values)|1.23|||||TWO_SIDED|95.0|-4.161|4.982|||||Confidence interval for the treatment difference was based on the Newcombe method. Percent treatment difference (TQ+CQ-PQ+CQ) has been presented.|||4.982|-4.161|
72415841|NCT02216123|144342519|OTHER||Hazard Ratio (HR)|0.984||||||95.0|0.577|1.678|||||Hazards ratio was estimated from Cox Proportional Hazards Model with treatment and region as covariates. A hazard ratio \<1 indicates a lower chance of relapse with TQ+CQ compared to PQ+CQ.|||1.678|0.577|
72415842|NCT02216123|144342520|OTHER||Hazard Ratio (HR)|0.815|||||TWO_SIDED|95.0|0.442|1.503|||||Hazard ratio was estimated from Cox Proportional Hazards Model with treatment and region as covariates. A hazard ratio\<1 indicates a lower chance of relapse with TQ+CQ compared to PQ+CQ.|||1.503|0.442|
72599014|NCT01119846|144728497|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.168|||||TWO_SIDED|95.0|-1.98|1.65|||||Comparison of Day 14, 24 Hours|||1.65|-1.98|
72599015|NCT01119846|144728497|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.043|||||TWO_SIDED|95.0|-2.81|0.73|||||Comparison of Day 14, 24 Hours|||0.73|-2.81|
72599016|NCT01119846|144728498|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-70.457|||||TWO_SIDED|95.0|-214.72|73.8|||||Day 7, 1 Hour|||73.80|-214.72|
72599017|NCT01119846|144728498|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-151.722|||||TWO_SIDED|95.0|-295.98|-7.46|||||Day 7, 1 Hour|||-7.46|-295.98|
72599018|NCT01119846|144728498|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-69.113|||||TWO_SIDED|95.0|-213.48|75.25|||||Day 7, 1 Hour|||75.25|-213.48|
72599019|NCT01119846|144728498|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-104.468|||||TWO_SIDED|95.0|-248.72|39.78|||||Day 7, 1 Hour|||39.78|-248.72|
72599020|NCT01119846|144728498|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-118.462|||||TWO_SIDED|95.0|-263.93|27.01|||||Day 7, 1 Hour|||27.01|-263.93|
72599021|NCT01119846|144728498|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-114.34|||||TWO_SIDED|95.0|-264.78|36.1|||||Day 7, 2 Hours|||36.10|-264.78|
72599022|NCT01119846|144728498|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-116.462|||||TWO_SIDED|95.0|-266.9|33.98|||||Day 7, 2 Hours|||33.98|-266.90|
72599023|NCT01119846|144728498|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.201|||||TWO_SIDED|95.0|-154.75|146.35|||||Day 7, 2 Hours|||146.35|-154.75|
72599024|NCT01119846|144728498|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-48.27|||||TWO_SIDED|95.0|-198.7|102.16|||||Day 7, 2 Hours|||102.16|-198.70|
72599025|NCT01119846|144728498|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-50.605|||||TWO_SIDED|95.0|-202.31|101.1|||||Day 7, 2 Hours|||101.10|-202.31|
72599026|NCT01119846|144728498|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-7.231|||||TWO_SIDED|95.0|-40.84|26.38|||||Day 7, 4 Hours|||26.38|-40.84|
72599027|NCT01119846|144728498|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.025|||||TWO_SIDED|95.0|-38.63|28.58|||||Day 7, 4 Hours|||28.58|-38.63|
72599028|NCT01119846|144728498|SUPERIORITY_OR_OTHER||Mean Difference (Net)|9.523|||||TWO_SIDED|95.0|-24.11|43.16|||||Day 7, 4 Hours|||43.16|-24.11|
72599029|NCT01119846|144728498|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.618|||||TWO_SIDED|95.0|-36.22|30.99|||||Day 7, 4 Hours|||30.99|-36.22|
72599030|NCT01119846|144728498|SUPERIORITY_OR_OTHER||Mean Difference (Net)|20.8|||||TWO_SIDED|95.0|-13.09|54.69|||||Day 7, 4 Hours|||54.69|-13.09|
72599031|NCT01119846|144728498|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-58.864|||||TWO_SIDED|95.0|-156.11|38.38|||||Day 7, 6 Hours|||38.38|-156.11|
72599032|NCT01119846|144728498|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-77.9|||||TWO_SIDED|95.0|-175.15|19.35|||||Day 7, 6 Hours|||19.35|-175.15|
72599033|NCT01119846|144728498|SUPERIORITY_OR_OTHER||Mean Difference (Net)|28.323|||||TWO_SIDED|95.0|-69.0|125.65|||||Day 7, 6 Hours|||125.65|-69.00|
72599034|NCT01119846|144728498|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-24.499|||||TWO_SIDED|95.0|-121.74|72.74|||||Day 7, 6 Hours|||72.74|-121.74|
72599035|NCT01119846|144728498|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-59.755|||||TWO_SIDED|95.0|-157.82|38.31|||||Day 7, 6 Hours|||38.31|-157.82|
72599036|NCT01119846|144728498|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.222|||||TWO_SIDED|95.0|-69.85|69.4|||||Day 7, 10 Hours|||69.40|-69.85|
72599037|NCT01119846|144728498|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.222|||||TWO_SIDED|95.0|-77.28|61.98|||||Day 7, 10 Hours|||61.98|-77.28|
72599038|NCT01119846|144728498|SUPERIORITY_OR_OTHER||Mean Difference (Net)|7.148|||||TWO_SIDED|95.0|-62.55|76.85|||||Day 7, 10 Hours|||76.85|-62.55|
72599039|NCT01119846|144728498|SUPERIORITY_OR_OTHER||Mean Difference (Net)|32.734|||||TWO_SIDED|95.0|-36.89|102.36|||||Day 7, 10 Hours|||102.36|-36.89|
72599040|NCT01119846|144728498|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-9.76|||||TWO_SIDED|95.0|-81.01|61.49|||||Day 7, 10 Hours|||61.49|-81.01|
72599041|NCT01119846|144728498|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-19.594|||||TWO_SIDED|95.0|-123.36|84.18|||||Day 7, 12 Hours|||84.18|-123.36|
72599042|NCT01119846|144728498|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-46.924|||||TWO_SIDED|95.0|-150.69|56.85|||||Day 7, 12 Hours|||56.85|-150.69|
72599043|NCT01119846|144728498|SUPERIORITY_OR_OTHER||Mean Difference (Net)|24.715|||||TWO_SIDED|95.0|-79.16|128.59|||||Day 7, 12 Hours|||128.59|-79.16|
72599044|NCT01119846|144728498|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-7.966|||||TWO_SIDED|95.0|-111.73|95.8|||||Day 7, 12 Hours|||95.80|-111.73|
72599045|NCT01119846|144728498|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.108|||||TWO_SIDED|95.0|-103.08|109.29|||||Day 7, 12 Hours|||109.29|-103.08|
72599046|NCT01119846|144728498|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-10.114|||||TWO_SIDED|95.0|-25.12|4.89|||||Day 14, 24 Hours|||4.89|-25.12|
72599047|NCT01119846|144728498|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-8.718|||||TWO_SIDED|95.0|-23.71|6.28|||||Day 14, 24 Hours|||6.28|-23.71|
72599048|NCT01119846|144728498|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.622|||||TWO_SIDED|95.0|-15.63|14.38|||||Day 14, 24 Hours|||14.38|-15.63|
72599049|NCT01119846|144728498|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-12.454|||||TWO_SIDED|95.0|-27.78|2.88|||||Day 14, 24 Hours|||2.88|-27.78|
72599050|NCT01119846|144728498|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-8.681|||||TWO_SIDED|95.0|-24.02|6.66|||||Day 14, 24 Hours|||6.66|-24.02|
72599051|NCT00795769|144728514|SUPERIORITY_OR_OTHER|||||||0.03|||||||t-test, 1 sided|||18% n=9 of the patients vomited compared to the FHCRC historic rate of 28%. p=0.03. PMID: 21372706 reference for historical data at FHCRC.||||0.03
72599052|NCT00795769|144728514|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 1 sided|||Twelve patients (24%) had a greater than two-point increase in MAT score for nausea from baseline by the end of their infusion. That rate compares to the FHCRC historic rate of 58% (p \<0.0001). PMID: 21372706 reference for historical data at FHCRC||||<0.0001
72599053|NCT03304184|144728517|EQUIVALENCE|In this analysis, the null hypothesis was that there was no significant difference in global base changes scores between the two treatment groups (Photac and Biodentine)|Mean Difference (Final Values)|3.0||||0.0001|TWO_SIDED|95.0|||||ANOVA||The estimation values were from an average of all values in each arm.|Power was limited sample size between the groups a superiority analysis was not able to be completed, so an equivalence test was used.||||.0001
72599054|NCT03304184|144728517|EQUIVALENCE|In this analysis, the null hypothesis was that there was no significant difference in global base changes scores between the two treatment groups (Photac and Biodentine) over timepoints|Mean Difference (Final Values)|3.0||||0.0005|TWO_SIDED|95.0|||||ANOVA||The estimation values were from an average of all values in each arm.|Power was limited sample size between the groups a superiority analysis was not able to be completed, so an equivalence test was used.||||.0005
72599055|NCT03304184|144728518|EQUIVALENCE|In this analysis, the null hypothesis was that there was no significant difference in 49 questions on oral health related quality of life scores between the two treatment groups (Photac and Biodentine).|Mean Difference (Final Values)|3.0||||0.091|TWO_SIDED|95.0||||Comparison between two groups for treatment|ANOVA||The estimation values were from an average of all values in each arm.|Power was limited sample size between the groups a superiority analysis was not able to be completed, so an equivalence test was used.||||.0910
72599056|NCT03304184|144728518|EQUIVALENCE|In this analysis, the null hypothesis was that there was no significant difference in 49 questions on oral health related quality of life scores between the two treatment groups (Photac and Biodentine) over time points|Mean Difference (Final Values)|3.0||||0.0262|TWO_SIDED|95.0||||Comparison between the two arms for treatment time points with analysis|ANOVA||The estimation values were from an average of all values in each arm.|Power was limited sample size between the groups a superiority analysis was not able to be completed, so an equivalence test was used.||||.0262
72599057|NCT03304184|144728519|EQUIVALENCE|In this analysis, the null hypothesis was that there was no significant difference in brief pain inventory scores between the two treatment groups (Photac and Biodentine) over different time points.|Mean Difference (Final Values)|3.0||||0.0289|TWO_SIDED|95.0|||||ANOVA||The estimation values were from an average of all values in each arm.|Power was limited sample size between the groups a superiority analysis was not able to be completed, so an equivalence test was used.||||.0289
72599058|NCT01370616|144728521|NON_INFERIORITY_OR_EQUIVALENCE|If the 95% confidence interval for the estimated difference between the two groups has a lower bound greater than -15%, then ertapenem sodium will be considered at least as effective as piperacillin/tazobactam sodium.|Estimated Difference|-3.8|||||TWO_SIDED|95.0|-8.3|0.0|||||Ertapenem minus Piperacillin/tazobactam. Based on Miettinen \& Nurminen method stratified by the severity of diabetes foot infection.|||0.0|-8.3|
72599059|NCT01370616|144728522|SUPERIORITY_OR_OTHER||Estimated Difference|-1.7|||||TWO_SIDED|95.0|-5.5|1.8|||||Ertapenem minus Piperacillin/tazobactam. Based on Miettinen \& Nurminen method stratified by the severity of diabetes foot infection.|||1.8|-5.5|
72599060|NCT01370616|144728523|SUPERIORITY_OR_OTHER||Estimated Difference|-2.3|||||TWO_SIDED|95.0|-7.7|2.8|||||Ertapenem minus Piperacillin/tazobactam. Based on Miettinen \& Nurminen method stratified by the severity of diabetes foot infection.|||2.8|-7.7|
72599061|NCT01370616|144728524|SUPERIORITY_OR_OTHER||Estimated Difference|-4.1|||||TWO_SIDED|95.0|-11.9|3.4|||||Ertapenem minus Piperacillin/tazobactam. Based on Miettinen \& Nurminen method stratified by the severity of diabetes foot infection.|||3.4|-11.9|
72599062|NCT01370616|144728525|SUPERIORITY_OR_OTHER||Estimated Difference|-4.3|||||TWO_SIDED|95.0|-12.1|3.3|||||Ertapenem minus Piperacillin/tazobactam. Based on Miettinen \& Nurminen method stratified by the severity of diabetes foot infection.|||3.3|-12.1|
72599063|NCT01370616|144728526|SUPERIORITY_OR_OTHER||Estimated Difference|7.3|||||TWO_SIDED|95.0|-0.9|15.4|||||Ertapenem minus Piperacillin/tazobactam group. Based on Miettinen \& Nurminen method without adjusting strata.|||15.4|-0.9|
72599064|NCT01370616|144728527|SUPERIORITY_OR_OTHER||Estimated Difference|-2.5|||||TWO_SIDED|95.0|-8.5|3.4|||||Ertapenem minus Piperacillin/tazobactam group. Based on Miettinen \& Nurminen method without adjusting strata.|||3.4|-8.5|
72599065|NCT01370616|144728528|SUPERIORITY_OR_OTHER||Estimated Difference|1.8|||||TWO_SIDED|95.0|-2.0|5.8|||||Ertapenem minus Piperacillin/tazobactam group. Based on Miettinen \& Nurminen method without adjusting strata.|||5.8|-2.0|
72599066|NCT01370616|144728529|SUPERIORITY_OR_OTHER||Estimated Difference|-1.8|||||TWO_SIDED|95.0|-5.7|1.9|||||Ertapenem minus Piperacillin/tazobactam group. Based on Miettinen \& Nurminen method without adjusting strata.|||1.9|-5.7|
72599067|NCT00212264|144728535|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED||||||ANOVA|||||||.001
72599068|NCT00212264|144728536|SUPERIORITY_OR_OTHER|||||||0.32|TWO_SIDED||||||t-test, 1 sided|Note that the no-treatment control group completed the study after 2 months and was not included in this analysis of treatment effect durability.||||||.32
72599069|NCT01578499|144728561|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|42.2|||<|0.001|TWO_SIDED|95.0|27.5|56.8||P-value was stratified by baseline disease diagnosis (pcALCL and MF).|Cochran-Mantel-Haenszel|||Based on a two-sided Χ² test with a significance level of 0.05, and a 10% dropout rate, a sample size of approximately 124 participants was calculated to provide 90% power to detect a 30% improvement in ORR4 in the brentuximab vedotin group.||56.8|27.5|<0.001
72599070|NCT01578499|144728562|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|15.6||||0.0002|TWO_SIDED|95.0|-2.5|33.0||P-value was stratified by baseline disease diagnosis (pcALCL and MF).|Cochran-Mantel-Haenszel|||||33.0|-2.5|0.0002
72599071|NCT01578499|144728563|OTHER||Hazard Ratio (HR)|0.378|||<|0.001|TWO_SIDED|95.0|0.247|0.577|||Log Rank||||Hazard ratio brentuximab vedotin/ comparator (methotrexate or bexarotene) with the 95% CI from a stratified Cox regression model with treatment as the explanatory variable and baseline disease diagnosis (MF or pcALCL) as stratification factor.|0.577|0.247|<0.001
72599072|NCT01578499|144728564|SUPERIORITY_OR_OTHER_LEGACY||Estimate of difference|-19.0|||<|0.001|TWO_SIDED|95.0|-26.7|-11.4|||ANCOVA|||P-value is calculated using the analysis of covariance (ANCOVA) model controlling for baseline symptom domain score, eastern cooperative oncology group (ECOG) performance status score (=0 and ≥1), and disease diagnosis (pcALCL and MF) between the brentuximab vedotin and comparator (methotrexate or bexarotene) arms.||-11.4|-26.7|<0.001
72599073|NCT02670382|144728576|SUPERIORITY||mean values, log transformed|||||0.33|||||||Mixed Models Analysis|||||||0.33
72599074|NCT02670382|144728576|SUPERIORITY||mean difference, log transformed values|||||0.92|||||||Mixed Models Analysis|||||||0.92
72599075|NCT02670382|144728576|SUPERIORITY||mean difference, log transformed values|||||0.44|||||||Mixed Models Analysis|||||||0.44
72599076|NCT02670382|144728577|SUPERIORITY||mean difference, log transformed values|||||0.34|||||||Mixed Models Analysis|||||||0.34
72599077|NCT02670382|144728577|SUPERIORITY||mean difference, log transformed values|||||0.5|||||||Mixed Models Analysis|||||||0.50
72599078|NCT02670382|144728577|SUPERIORITY||mean differences, log transformed values|||||0.83|||||||Mixed Models Analysis|||||||0.83
72599079|NCT02670382|144728578|EQUIVALENCE|primary hypothesis is that EPA will not differ from placebo|mean differences|||||0.1|||||||Mixed Models Analysis|||||||0.10
72599080|NCT02670382|144728578|SUPERIORITY||mean difference|||||0.005|||||||Mixed Models Analysis|||||||0.005
72599081|NCT02670382|144728578|SUPERIORITY|||||||0.17|||||||Mixed Models Analysis|||||||0.17
72599082|NCT03244618|144728579|SUPERIORITY||Mean Difference (Final Values)|-0.544|||<|0.001|TWO_SIDED|95.0|-0.712|-0.377|||ANOVA|ANOVA model had treatment and gender as factors.|Difference is first named toothpaste minus second named toothpaste such that a negative difference favours first named toothpaste.|||-0.377|-0.712|<0.001
72599083|NCT03244618|144728580|SUPERIORITY||Mean Difference (Final Values)|10.8|||<|0.001|TWO_SIDED|95.0|7.5|14.0|||ANOVA|ANOVA model had treatment and gender as factors.|Difference is first names toothpaste minus second named toothpaste such that a positive difference favours the first named toothpaste.|||14.0|7.5|<0.001
72599084|NCT03244618|144728581|SUPERIORITY||Mean Difference (Final Values)|-11.0|||<|0.001|TWO_SIDED|95.0|-16.4|-5.5|||ANOVA|ANOVA model had treatment and gender as factors.|Difference is first named toothpaste minus second named toothpaste such that a negative difference favours the first named toothpaste.|||-5.5|-16.4|<0.001
72599085|NCT03244618|144728582|SUPERIORITY||Mean Difference (Final Values)|-0.67|||<|0.001|TWO_SIDED|95.0|-0.85|-0.489|||ANOVA|ANOVA model had treatment and gender as factors.|Difference is first named toothpaste minus second named toothpaste such that a negative value favours the first named toothpaste.|||-0.489|-0.850|<0.001
72599086|NCT03244618|144728583|SUPERIORITY||Mean Difference (Final Values)|11.9|||<|0.001|TWO_SIDED|95.0|8.6|15.1|||ANOVA|ANOVA model had treatment and gender as factors.|Difference is first named toothpaste minus second named toothpaste such that a positive difference favours first named toothpaste|||15.1|8.6|<0.001
72599087|NCT03244618|144728584|SUPERIORITY||Mean Difference (Final Values)|-10.9|||<|0.001|TWO_SIDED|95.0|-16.6|-5.2|||ANOVA|ANOVA model had treatment and gender as factors.|Difference is first named toothpaste minus second named toothpaste such that a negative difference favours the first named toothpaste.|||-5.2|-16.6|<0.001
72599088|NCT01945294|144728607|SUPERIORITY_OR_OTHER||Difference in SVR12 percentage|-11.4|||||TWO_SIDED|95.0|-23.2|0.4||||||||0.4|-23.2|
72599089|NCT01483599|144728645|SUPERIORITY_OR_OTHER|||||||0.002|||||||Cochran-Mantel-Haenszel chi-square test|||p-value was based on the Cochran-Mantel-Haenszel chi-square test stratified by baseline weight (less than or equal to (\<=) 90 kilogram (kg), greater than (\>) 90 kg).||||0.002
72599090|NCT01483599|144728645|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel chi-square test|||p-value was based on the Cochran-Mantel-Haenszel chi-square test stratified by baseline weight (\<=90 kg, \>90 kg).||||< 0.001
72599091|NCT01483599|144728645|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel chi-square test|||p-value was based on the Cochran-Mantel-Haenszel chi-square test stratified by baseline weight (\<=90 kg, \>90 kg).||||< 0.001
72421613|NCT03720938|144354384|SUPERIORITY|||||||0.006602||||||Linear mixed-effects model fit by maximum likelihood since restricted maximum likelihood assumes a strong normality.|Linear mixed-effects model|Adjusted by Satterthwaite's degrees of freedom method for cluster effect, and small sample sizes in addition to baseline value and age.||Null hypothesis was the absence of difference between the two groups for the dependent variable auditory reaction time of non-dominant hand.||||0.006602
72599092|NCT01483599|144728645|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel chi-square test|||p-value was based on the Cochran-Mantel-Haenszel chi-square test stratified by baseline weight (\<=90 kg, \>90 kg).||||< 0.001
72599093|NCT01483599|144728645|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel chi-square test|||p-value was based on the Cochran-Mantel-Haenszel chi-square test stratified by baseline weight (\<=90 kg, \>90 kg).||||< 0.001
72599094|NCT01483599|144728645|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel chi-square test|||p-value was based on the Cochran-Mantel-Haenszel chi-square test stratified by baseline weight (\<=90 kg, \>90 kg).||||< 0.001
72599095|NCT01483599|144728646|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel chi-square test|||p-value was based on the Cochran-Mantel-Haenszel chi-square test stratified by baseline weight (\<=90 kg, \>90 kg).||||< 0.001
72599096|NCT01483599|144728646|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel chi-square test|||p-value was based on the Cochran-Mantel-Haenszel chi-square test stratified by baseline weight (\<=90 kg, \>90 kg).||||< 0.001
72421614|NCT03720938|144354385|SUPERIORITY|||||||0.615648||||||The outcome of self-perception for sports competence was tested for any difference between groups by covariate analysis.|ANCOVA|Adjusted for self-perception for sports competence at baseline and confounding variable age.||Null hypothesis was the absence of difference between the two groups for the dependent variable self-perception of sports competence.||||0.615648
72599097|NCT01483599|144728646|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel chi-square test|||p-value was based on the Cochran-Mantel-Haenszel chi-square test stratified by baseline weight (\<=90 kg, \>90 kg).||||< 0.001
72599098|NCT01483599|144728646|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel chi-square test|||p-value was based on the Cochran-Mantel-Haenszel chi-square test stratified by baseline weight (\<=90 kg, \>90 kg).||||< 0.001
72599099|NCT01483599|144728646|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel chi-square test|||p-value was based on the Cochran-Mantel-Haenszel chi-square test stratified by baseline weight (\<=90 kg, \>90 kg).||||< 0.001
72599100|NCT01483599|144728646|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel chi-square test|||p-value was based on the Cochran-Mantel-Haenszel chi-square test stratified by baseline weight (\<=90 kg, \>90 kg).||||< 0.001
72599101|NCT01483599|144728647|SUPERIORITY_OR_OTHER||Difference in Percentage|-24.0|||||TWO_SIDED|95.0|-44.0|-4.0||||||The difference in percentage was calculated as the percentage of CNTO 1959 participants achieving a PGA score of cleared (0) or minimal (1) minus percentage of adalimumab participants achieving a PGA score of cleared (0) or minimal (1).||-4.0|-44.0|
72599102|NCT01483599|144728647|SUPERIORITY_OR_OTHER||Difference in Percentage|2.8|||||TWO_SIDED|95.0|-17.9|23.5||||||The difference in percentage was calculated as the percentage of CNTO 1959 participants achieving a PGA score of cleared (0) or minimal (1) minus percentage of adalimumab participants achieving a PGA score of cleared (0) or minimal (1).||23.5|-17.9|
72599103|NCT01483599|144728647|SUPERIORITY_OR_OTHER||Difference in Percentage|20.4|||||TWO_SIDED|95.0|1.5|39.3||||||The difference in percentage was calculated as the percentage of CNTO 1959 participants achieving a PGA score of cleared (0) or minimal (1) minus percentage of adalimumab participants achieving a PGA score of cleared (0) or minimal (1).||39.3|1.5|
72599104|NCT01483599|144728647|SUPERIORITY_OR_OTHER||Difference in Percentage|27.7|||||TWO_SIDED|95.0|9.8|45.6||||||The difference in percentage was calculated as the percentage of CNTO 1959 participants achieving a PGA score of cleared (0) or minimal (1) minus percentage of adalimumab participants achieving a PGA score of cleared (0) or minimal (1).||45.6|9.8|
72599105|NCT01483599|144728647|SUPERIORITY_OR_OTHER||Difference in Percentage|25.4|||||TWO_SIDED|95.0|7.2|43.6||||||||43.6|7.2|
72599106|NCT01483599|144728648|SUPERIORITY_OR_OTHER||Difference in Percentage|-15.4|||||TWO_SIDED|95.0|-37.7|6.9||||||The difference in percentage was calculated as the percentage of CNTO 1959 participants achieving a PGA score of cleared (0) or minimal (1) minus percentage of adalimumab participants achieving a PGA score of cleared (0) or minimal (1).||6.9|-37.7|
72599107|NCT01483599|144728648|SUPERIORITY_OR_OTHER||Difference in Percentage|10.8|||||TWO_SIDED|95.0|-10.7|32.4||||||The difference in percentage was calculated as the percentage of CNTO 1959 participants achieving a PGA score of cleared (0) or minimal (1) minus percentage of adalimumab participants achieving a PGA score of cleared (0) or minimal (1).||32.4|-10.7|
72599108|NCT01483599|144728648|SUPERIORITY_OR_OTHER||Difference in Percentage|22.7|||||TWO_SIDED|95.0|1.8|43.6||||||The difference in percentage was calculated as the percentage of CNTO 1959 participants achieving a PGA score of cleared (0) or minimal (1) minus percentage of adalimumab participants achieving a PGA score of cleared (0) or minimal (1).||43.6|1.8|
72599109|NCT01483599|144728648|SUPERIORITY_OR_OTHER||Difference in Percentage|28.7|||||TWO_SIDED|95.0|8.5|49.0||||||The difference in percentage was calculated as the percentage of CNTO 1959 participants achieving a PGA score of cleared (0) or minimal (1) minus percentage of adalimumab participants achieving a PGA score of cleared (0) or minimal (1).||49.0|8.5|
72421615|NCT03720938|144354385|SUPERIORITY|||||||0.608||||||Linear mixed-effects model fit by maximum likelihood since restricted maximum likelihood assumes a strong normality.|Linear mixed effects model|Adjusted for cluster effect in addition to baseline value and age.||The outcome of self-perception for sports competence was tested for any difference between groups by linear mixed-effects model analysis.||||0.608
72599110|NCT01483599|144728648|SUPERIORITY_OR_OTHER||Difference in Percentage|32.9|||||TWO_SIDED|95.0|13.0|52.8||||||The difference in percentage was calculated as the percentage of CNTO 1959 participants achieving a PGA score of cleared (0) or minimal (1) minus percentage of adalimumab participants achieving a PGA score of cleared (0) or minimal (1).||52.8|13.0|
72599111|NCT01483599|144728649|SUPERIORITY_OR_OTHER|||||||0.008|||||||ANOVA on the van Der Waerden score|||||||0.008
72599112|NCT01483599|144728649|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA on the van Der Waerden score|||||||< 0.001
72599113|NCT01483599|144728649|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA on the van Der Waerden score|||||||< 0.001
72599114|NCT01483599|144728649|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA on the van Der Waerden score|||||||< 0.001
72599115|NCT01483599|144728649|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA on the van Der Waerden score|||||||< 0.001
72599116|NCT01483599|144728649|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA on the van Der Waerden score|||||||< 0.001
72599117|NCT00410072|144728685|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.9||||0.0882|TWO_SIDED|95.0|-1.0|14.9|||Cochran-Mantel-Haenszel|||Week 96||14.9|-1.0|0.0882
72599118|NCT00410072|144728686|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.5|||||TWO_SIDED|95.0|2.3|24.8|||NC=F|||||24.8|2.3|
72599119|NCT00410072|144728686|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.2|||||TWO_SIDED|95.0|-7.7|12.0|||NC=F|||||12.0|-7.7|
72599120|NCT00410072|144728686|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.6||||0.046|TWO_SIDED|95.0|0.2|21.0|||Cochran-Mantel-Haenszel|||||21.0|0.2|0.0460
72599121|NCT00410072|144728686|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.2|||||TWO_SIDED|95.0|-12.0|9.5|||NC=F|||||9.5|-12.0|
72599122|NCT00410072|144728687|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.1|||||TWO_SIDED|95.0|-1.8|16.0|||NC=F|||Analysis at week 48. The stratified analysis was based on HBeAg strata at randomization.||16.0|-1.8|
72599123|NCT00410072|144728687|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.1|||||TWO_SIDED|95.0|-1.1|15.2|||NC=F|||Analysis at week 96. The stratified analysis was based on HBeAg strata at randomization.||15.2|-1.1|
72599124|NCT00410072|144728688|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.8|||||TWO_SIDED|95.0|-1.5|17.1|||NC=F|||Analysis at Week 48. The stratified analysis was based on HBeAg strata at randomization.||17.1|-1.5|
72599125|NCT00410072|144728688|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.6|||||TWO_SIDED|95.0|-0.2|17.3|||NC=F|||Analysis at Week 96. The stratified analysis was based on HBeAg strata at randomization.||17.3|-0.2|
72599126|NCT00410072|144728690|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.4|||||TWO_SIDED|95.0|-18.8|-2.0|||NC+F|||Analysis at Week 48. The stratified analysis is based on HBeAg strata at randomization.||-2.0|-18.8|
72599127|NCT00410072|144728690|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.8|||||TWO_SIDED|95.0|-21.5|-4.1|||NC=F|||Analysis at Week 96. The stratified analysis is based on HBeAg strata at randomization.||-4.1|-21.5|
72599128|NCT00410072|144728691|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.8|||||TWO_SIDED|95.0|-15.9|4.2|||NC=F|||Analysis at Week 48||4.2|-15.9|
72599129|NCT00410072|144728691|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.2|||||TWO_SIDED|95.0|-20.6|2.3|||NC=F|||Analysis at Week 96||2.3|-20.6|
72599130|NCT00410072|144728692|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.1|||||TWO_SIDED|95.0|-13.8|5.6|||NC=F|||Analysis at Week 48||5.6|-13.8|
72599131|NCT00410072|144728692|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.8|||||TWO_SIDED|95.0|-21.5|-0.1|||NC=F|||Analysis at Week 96||-0.1|-21.5|
72599132|NCT00410072|144728693|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.7|||||TWO_SIDED|95.0|-5.3|1.9|||NC=F|||Analysis at Week 48||1.9|-5.3|
72599133|NCT00410072|144728693|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.1|||||TWO_SIDED|95.0|-3.9|6.1|||NC=F|||Analysis at Week 96||6.1|-3.9|
72599134|NCT00410072|144728694|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|||||TWO_SIDED|95.0|-2.2|2.0|||NC=F|||Analysis at Week 48||2.0|-2.2|
72599135|NCT00410072|144728694|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.3|||||TWO_SIDED|95.0|-2.3|4.9|||NC=F|||Analysis at Week 96||4.9|-2.3|
72599136|NCT01421147|144728708|SUPERIORITY_OR_OTHER||LS Mean Difference|0.108||||0.055|TWO_SIDED|95.0|-0.002|0.219|||ANCOVA|||||0.219|-0.002|0.055
72599137|NCT01421147|144728709|SUPERIORITY_OR_OTHER||LS Mean Difference|0.41||||0.205|TWO_SIDED|95.0|-0.23|1.05||P-value is for change at 6 weeks.|ANCOVA|||||1.05|-0.23|0.205
72599138|NCT01421147|144728709|SUPERIORITY_OR_OTHER||LS Mean difference|0.4||||0.32|TWO_SIDED|95.0|-0.4|1.21||P-value is for change at 12 weeks.|ANCOVA|||||1.21|-0.40|0.320
72599139|NCT01421147|144728709|SUPERIORITY_OR_OTHER||LS Mean Difference|0.37||||0.373|TWO_SIDED|95.0|-0.46|1.21||P-value is for change at Endpoint, up to 24 weeks.|ANCOVA|||||1.21|-0.46|0.373
72599140|NCT01421147|144728709|SUPERIORITY_OR_OTHER||LS Mean Difference|0.81||||0.131|TWO_SIDED|95.0|-0.25|1.86||P-value is for change at Endpoint, up to 52 weeks.|ANCOVA|||||1.86|-0.25|0.131
72599141|NCT01421147|144728710|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.007||||0.86|TWO_SIDED|95.0|-0.087|0.072||P-value is for change at 6 weeks.|ANCOVA|||||0.072|-0.087|0.860
72599142|NCT01421147|144728710|SUPERIORITY_OR_OTHER||LS Mean Difference|0.113||||0.03|TWO_SIDED|95.0|0.011|0.215||P-value is for change at 12 weeks.|ANCOVA|||||0.215|0.011|0.030
72599143|NCT01421147|144728710|SUPERIORITY_OR_OTHER||LS Mean Difference|0.098||||0.08|TWO_SIDED|95.0|-0.012|0.208||P-value is for change at 24 weeks.|ANCOVA|||||0.208|-0.012|0.080
72599144|NCT01421147|144728710|SUPERIORITY_OR_OTHER||LS Mean Difference|0.06||||0.314|TWO_SIDED|95.0|-0.057|0.177||P-value is for change at 36 weeks.|ANCOVA|||||0.177|-0.057|0.314
72599145|NCT01421147|144728710|SUPERIORITY_OR_OTHER||LS Mean Difference|0.004||||0.948|TWO_SIDED|95.0|-0.119|0.127||P-value is for change at 52 weeks.|ANCOVA|||||0.127|-0.119|0.948
72599146|NCT01421147|144728710|SUPERIORITY_OR_OTHER||LS Mean Difference|0.02||||0.737|TWO_SIDED|95.0|-0.099|0.14||P-value is for change at Endpoint, up to 52 weeks.|ANCOVA|||||0.140|-0.099|0.737
72599147|NCT01421147|144728711|SUPERIORITY_OR_OTHER||LS Mean Difference|0.18||||0.489|TWO_SIDED|95.0|-0.33|0.69||P-value is for Baseline-AM Pre-Meal.|ANCOVA|||||0.69|-0.33|0.489
72599148|NCT01421147|144728711|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.48||||0.066|TWO_SIDED|95.0|-1.0|0.03||P-value is for Baseline-AM 2 hrs PP.|ANCOVA|||||0.03|-1.00|0.066
72599149|NCT01421147|144728711|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.28||||0.209|TWO_SIDED|95.0|-0.71|0.16||P-value is for Baseline-MD Pre-Meal.|ANCOVA|||||0.16|-0.71|0.209
72599150|NCT01421147|144728711|SUPERIORITY_OR_OTHER||LS Mean Difference|0.31||||0.232|TWO_SIDED|95.0|-0.2|0.82||P-value is for Baseline-MD 2 hrs PP.|ANCOVA|||||0.82|-0.20|0.232
72599151|NCT01421147|144728711|SUPERIORITY_OR_OTHER||LS Mean Difference|0.05||||0.856|TWO_SIDED|95.0|-0.49|0.58||P-value is for Baseline-EV Pre-Meal.|ANCOVA|||||0.58|-0.49|0.856
72599152|NCT01421147|144728711|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.11||||0.693|TWO_SIDED|95.0|-0.66|0.44||P-value is for Baseline-Bed Time.|ANCOVA|||||0.44|-0.66|0.693
72599153|NCT01421147|144728711|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1||||0.7|TWO_SIDED|95.0|-0.61|0.41||P-value is for Baseline-0300 hrs.|ANCOVA|||||0.41|-0.61|0.700
72599154|NCT01421147|144728711|SUPERIORITY_OR_OTHER||LS Mean Difference|0.17||||0.399|TWO_SIDED|95.0|-0.23|0.58||P-value is for Endpoint, up to 24 wk-AM Pre-Meal.|ANCOVA|||||0.58|-0.23|0.399
72599155|NCT01421147|144728711|SUPERIORITY_OR_OTHER||LS Mean Difference|0.25||||0.248|TWO_SIDED|95.0|-0.18|0.68||P-value is for Endpoint, up to 24 wk-AM 2 hrs PP.|ANCOVA|||||0.68|-0.18|0.248
72599156|NCT01421147|144728711|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.03||||0.883|TWO_SIDED|95.0|-0.44|0.38||P-value is for Endpoint, up to 24 wk-MD Pre-Meal.|ANCOVA|||||0.38|-0.44|0.883
72599157|NCT01421147|144728711|SUPERIORITY_OR_OTHER||LS Mean Difference|0.09||||0.687|TWO_SIDED|95.0|-0.34|0.52||P-value is for Endpoint, up to 24 wk-MD 2 hrs PP.|ANCOVA|||||0.52|-0.34|0.687
72599158|NCT01421147|144728711|SUPERIORITY_OR_OTHER||LS Mean Difference|0.2||||0.364|TWO_SIDED|95.0|-0.24|0.65||P-value is for Endpoint, up to 24 wk-EV Pre-Meal.|ANCOVA|||||0.65|-0.24|0.364
72599159|NCT01421147|144728711|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.5||||0.03|TWO_SIDED|95.0|-0.95|-0.05||P-value is for Endpoint, up to 24 wk- Bed Time.|ANCOVA|||||-0.05|-0.95|0.030
72599160|NCT01421147|144728711|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.45||||0.033|TWO_SIDED|95.0|-0.86|-0.04||P-value is for Endpoint, up to 24 wk-0300 hrs.|ANCOVA|||||-0.04|-0.86|0.033
72599161|NCT01421147|144728711|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.26||||0.23|TWO_SIDED|95.0|-0.68|0.16||P-value is for Endpoint, up to 52 wk-AM Pre-Meal.|ANCOVA|||||0.16|-0.68|0.230
72599162|NCT01421147|144728711|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.32||||0.148|TWO_SIDED|95.0|-0.76|0.11||P-value is for Endpoint, up to 52 wk-AM 2 hrs PP.|ANCOVA|||||0.11|-0.76|0.148
72599163|NCT01421147|144728711|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.03||||0.866|TWO_SIDED|95.0|-0.43|0.36||P-value is for Endpoint, up to 52 wk-MD Pre-Meal.|ANCOVA|||||0.36|-0.43|0.866
72599164|NCT01421147|144728711|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.13||||0.545|TWO_SIDED|95.0|-0.56|0.3||P-value is for Endpoint, up to 52 wk-MD 2 hrs PP.|ANCOVA|||||0.30|-0.56|0.545
72599165|NCT01421147|144728711|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.01||||0.955|TWO_SIDED|95.0|-0.44|0.42||P-value is for Endpoint, up to 52 wk-EV Pre-Meal.|ANCOVA|||||0.42|-0.44|0.955
72599166|NCT01421147|144728711|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.48||||0.031|TWO_SIDED|95.0|-0.92|-0.04||P-value is for Endpoint, up to 52 wk-Bed Time.|ANCOVA|||||-0.04|-0.92|0.031
72599167|NCT01421147|144728711|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.21||||0.355|TWO_SIDED|95.0|-0.65|0.23||P-vale is for Endpoint, up to 52 wk-0300 hrs.|ANCOVA|||||0.23|-0.65|0.355
72599168|NCT01421147|144728712|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.17||||0.32|TWO_SIDED|95.0|-0.52|0.17||P-value is for Baseline.|ANCOVA|||||0.17|-0.52|0.320
72599169|NCT01421147|144728712|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.04||||0.781|TWO_SIDED|95.0|-0.33|0.25||P-value is for Endpoint, up to 24 weeks.|ANCOVA|||||0.25|-0.33|0.781
72599170|NCT01421147|144728712|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.26||||0.06|TWO_SIDED|95.0|-0.53|0.01||P-value is for Endpoint, up to 52 weeks.|ANCOVA|||||0.01|-0.53|0.060
72599171|NCT01421147|144728713|SUPERIORITY_OR_OTHER||LS Mean Difference|0.03||||0.823|TWO_SIDED|95.0|-0.23|0.29||P-value is for change at 6 weeks.|ANCOVA|||||0.29|-0.23|0.823
72599172|NCT01421147|144728713|SUPERIORITY_OR_OTHER||LS Mean Difference|0.11||||0.541|TWO_SIDED|95.0|-0.25|0.47||P-value is for change at 12 weeks.|ANCOVA|||||0.47|-0.25|0.541
72599173|NCT01421147|144728713|SUPERIORITY_OR_OTHER||LS Mean Difference|0.17||||0.435|TWO_SIDED|95.0|-0.25|0.59||P-value is for change at 18 weeks.|ANCOVA|||||0.59|-0.25|0.435
72599174|NCT01421147|144728713|SUPERIORITY_OR_OTHER||LS Mean Difference|0.24||||0.32|TWO_SIDED|95.0|-0.23|0.71||P-value is for change at Endpoint, up to 24 weeks.|ANCOVA|||||0.71|-0.23|0.320
72599175|NCT01421147|144728713|SUPERIORITY_OR_OTHER||LS Mean Difference|0.34||||0.253|TWO_SIDED|95.0|-0.25|0.93||P-value is for change at Endpoint, up to 52 weeks.|ANCOVA|||||0.93|-0.25|0.253
72599176|NCT01421147|144728714|SUPERIORITY_OR_OTHER||LS Mean Difference|0.64||||0.401|TWO_SIDED|95.0|-0.86|2.15||P-value is for Baseline-Behavior TS.|ANCOVA|||||2.15|-0.86|0.401
72599177|NCT01421147|144728714|SUPERIORITY_OR_OTHER||LS Mean Difference|0.2||||0.778|TWO_SIDED|95.0|-1.16|1.55||P-value is for 24 weeks-Behavior TS|ANCOVA|||||1.55|-1.16|0.778
72599178|NCT01421147|144728714|SUPERIORITY_OR_OTHER||LS Mean Difference|0.16||||0.804|TWO_SIDED|95.0|-1.12|1.45||P-value is for Endpoint, up to 52 weeks-Behavior TS.|ANCOVA|||||1.45|-1.12|0.804
72599179|NCT01421147|144728714|SUPERIORITY_OR_OTHER||LS Mean Difference|1.21||||0.304||95.0|-1.1|3.51||P-value is for Baseline-Worry TS.|ANCOVA|||||3.51|-1.10|0.304
72599180|NCT01421147|144728714|SUPERIORITY_OR_OTHER||LS Mean Difference|1.12||||0.323|TWO_SIDED|95.0|-1.1|3.34||P-value is for 24 weeks-Worry TS.|ANCOVA|||||3.34|-1.10|0.323
72599181|NCT01421147|144728714|SUPERIORITY_OR_OTHER||LS Mean Difference|0.25||||0.824||95.0|-1.92|2.41||P-value is for Endpoint, up to 52 weeks-Worry TS.|ANCOVA|||||2.41|-1.92|0.824
72599182|NCT01421147|144728715|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.77||||0.681|TWO_SIDED|95.0|-4.42|2.89||P-value is for IR-Baseline.|ANCOVA|||||2.89|-4.42|0.681
72599183|NCT01421147|144728715|SUPERIORITY_OR_OTHER||LS Mean Difference|0.56||||0.744|TWO_SIDED|95.0|-2.79|3.9||P-value is for IR-24 weeks.|ANCOVA|||||3.90|-2.79|0.744
72599184|NCT01421147|144728715|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.94||||0.582|TWO_SIDED|95.0|-4.29|2.41||P-value is for IR-Endpoint, up to 52 weeks.|ANCOVA|||||2.41|-4.29|0.582
72599185|NCT01421147|144728715|SUPERIORITY_OR_OTHER||LS Mean Difference|0.82||||0.694|TWO_SIDED|95.0|-3.26|4.89||P-value is for LF-Baseline.|ANCOVA|||||4.89|-3.26|0.694
72599186|NCT01421147|144728715|SUPERIORITY_OR_OTHER||LS Mean Difference|0.84||||0.673|TWO_SIDED|95.0|-3.08|4.77||P-value is for LF-24 weeks.|ANCOVA|||||4.77|-3.08|0.673
72599187|NCT01421147|144728715|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.91||||0.645|TWO_SIDED|95.0|-4.79|2.97||P-value is for LF-Endpoint, up to 52 weeks.|ANCOVA|||||2.97|-4.79|0.645
72599188|NCT01421147|144728715|SUPERIORITY_OR_OTHER||LS Mean Difference|0.09||||0.961|TWO_SIDED|95.0|-3.62|3.81||P-value is for GC-Baseline.|ANCOVA|||||3.81|-3.62|0.961
72599189|NCT01421147|144728715|SUPERIORITY_OR_OTHER||LS Mean Difference|1.25||||0.463|TWO_SIDED|95.0|-2.1|4.61||P-value is for GC-24 weeks.|ANCOVA|||||4.61|-2.10|0.463
72599190|NCT01421147|144728715|SUPERIORITY_OR_OTHER||LS Mean Difference|0.91||||0.609|TWO_SIDED|95.0|-2.59|4.41||P-value is for GC-Endpoint, up to 52 weeks.|ANCOVA|||||4.41|-2.59|0.609
72599191|NCT01421147|144728715|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.61||||0.708|TWO_SIDED|95.0|-3.81|2.59||P-value is for HC-Baseline.|ANCOVA|||||2.59|-3.81|0.708
72599192|NCT01421147|144728715|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.03||||0.51|TWO_SIDED|95.0|-4.09|2.03||P-value is for HC-24 weeks.|ANCOVA|||||2.03|-4.09|0.510
72599193|NCT01421147|144728715|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.26||||0.422|TWO_SIDED|95.0|-4.34|1.82||P-value is for HC-Endpoint, up to 52 weeks.|ANCOVA|||||1.82|-4.34|0.422
72599194|NCT01421147|144728715|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.53||||0.367|TWO_SIDED|95.0|-4.85|1.8||P-value is for IDD-Baseline.|ANCOVA|||||1.80|-4.85|0.367
72599195|NCT01421147|144728715|SUPERIORITY_OR_OTHER||LS Mean Difference|0.41||||0.786|TWO_SIDED|95.0|-2.54|3.35||P-value is for IDD-24 weeks.|ANCOVA|||||3.35|-2.54|0.786
72599196|NCT01421147|144728715|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.29||||0.845|TWO_SIDED|95.0|-3.16|2.59||P-value is for IDD-Endpoint, up to 52 weeks.|ANCOVA|||||2.59|-3.16|0.845
72599197|NCT01421147|144728715|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.59||||0.676|TWO_SIDED|95.0|-3.36|2.18||P-value is for ITSQ Total-Baseline.|ANCOVA|||||2.18|-3.36|0.676
72599198|NCT01421147|144728715|SUPERIORITY_OR_OTHER||LS Mean Difference|0.23||||0.862|TWO_SIDED|95.0|-2.33|2.78||P-value is for ITSQ Total-24 weeks.|ANCOVA|||||2.78|-2.33|0.862
72599199|NCT01421147|144728715|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.54||||0.685|TWO_SIDED|95.0|-3.15|2.07||P-value is for ITSQ Total-Endpoint, up to 52 weeks.|ANCOVA|||||2.07|-3.15|0.685
72599200|NCT01421147|144728716|SUPERIORITY_OR_OTHER||LS Mean Difference|0.014||||0.235|TWO_SIDED|95.0|-0.009|0.036||P-value is for Endpoint, up to 24 wk-Basal Insulin.|ANCOVA|||||0.036|-0.009|0.235
72599201|NCT01421147|144728716|SUPERIORITY_OR_OTHER||LS Mean Difference|0.006||||0.726|TWO_SIDED|95.0|-0.026|0.038||P-value is for Endpoint, up to 24 wk-Bolus Insulin.|ANCOVA|||||0.038|-0.026|0.726
72599202|NCT01421147|144728716|SUPERIORITY_OR_OTHER||LS Mean Difference|0.019||||0.377|TWO_SIDED|95.0|-0.023|0.062||P-value is for Endpoint, up to 24 wk-Total Insulin.|ANCOVA|||||0.062|-0.023|0.377
72599203|NCT01421147|144728716|SUPERIORITY_OR_OTHER||LS Mean Difference|0.018||||0.159|TWO_SIDED|95.0|-0.007|0.042||P-value is for Endpoint, up to 52 wk-Basal Insulin.|ANCOVA|||||0.042|-0.007|0.159
72599204|NCT01421147|144728716|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.001||||0.957|TWO_SIDED|95.0|-0.034|0.032||P-value is for Endpoint, up to 52 wk-Bolus Insulin.|ANCOVA|||||0.032|-0.034|0.957
72599205|NCT01421147|144728716|SUPERIORITY_OR_OTHER||LS Mean Difference|0.017||||0.45|TWO_SIDED|95.0|-0.028|0.062||P-value is for Endpoint, up to 52 wk-Total Insulin.|ANCOVA|||||0.062|-0.028|0.450
72599206|NCT01421147|144728717|SUPERIORITY_OR_OTHER||LS Mean Difference|1.724||||0.096|TWO_SIDED|95.0|-0.308|3.755||P-value is for Endpoint, up to 24 wk-Basal Insulin.|ANCOVA|||||3.755|-0.308|0.096
72599207|NCT01421147|144728717|SUPERIORITY_OR_OTHER||LS Mean Difference|1.267||||0.374|TWO_SIDED|95.0|-1.531|4.065||P-value is for Endpoint, up to 24 wk-Bolus Insulin.|ANCOVA|||||4.065|-1.531|0.374
72599208|NCT01421147|144728717|SUPERIORITY_OR_OTHER||LS Mean Difference|2.964||||0.151|TWO_SIDED|95.0|-1.081|7.01||P-value is for Endpoint, up to 24 wk-Total Insulin.|ANCOVA|||||7.010|-1.081|0.151
72599209|NCT01421147|144728717|SUPERIORITY_OR_OTHER||LS Mean Difference|2.059||||0.072|TWO_SIDED|95.0|-0.187|4.305||P-value is for Endpoint, up to 52 wk-Basal Insulin.|ANCOVA|||||4.305|-0.187|0.072
72599210|NCT01421147|144728717|SUPERIORITY_OR_OTHER||LS Mean Difference|0.702||||0.617|TWO_SIDED|95.0|-2.058|3.462||P-value is for Endpoint, up to 52 wk-Bolus Insulin.|ANCOVA|||||3.462|-2.058|0.617
72599211|NCT01421147|144728717|SUPERIORITY_OR_OTHER||LS Mean Difference|2.8||||0.188|TWO_SIDED|95.0|-1.37|6.971||P-value is for Endpoint, up to 52 wk-Total Insulin.|ANCOVA|||||6.971|-1.370|0.188
72599212|NCT01421147|144728718|SUPERIORITY_OR_OTHER|||||||0.015||||||P-value is for HbA1c- at Baseline \<7.0 %.|Fisher Exact|||||||0.015
72599213|NCT01421147|144728718|SUPERIORITY_OR_OTHER|||||||0.606||||||P-value is for HbA1c- at Baseline ≤6.5%.|Fisher Exact|||||||0.606
72599214|NCT01421147|144728718|SUPERIORITY_OR_OTHER|||||||0.012||||||P-value is for HbA1c- at 6 weeks \<7.0%.|Fisher Exact|||||||0.012
72599215|NCT01421147|144728718|SUPERIORITY_OR_OTHER|||||||0.053||||||P-value is for HbA1c- at 6 weeks ≤6.5%.|Fisher Exact|||||||0.053
72599216|NCT01421147|144728718|SUPERIORITY_OR_OTHER|||||||0.398||||||P-value is for HbA1c- at 12 weeks \<7.0%.|Fisher Exact|||||||0.398
72599217|NCT01421147|144728718|SUPERIORITY_OR_OTHER|||||||0.17||||||P-value is for HbA1c- at 12 weeks ≤6.5%.|Fisher Exact|||||||0.170
72599218|NCT01421147|144728718|SUPERIORITY_OR_OTHER|||||||0.926||||||P-value is for HbA1c- at 24 weeks \<7.0%.|Fisher Exact|||||||0.926
72599219|NCT01421147|144728718|SUPERIORITY_OR_OTHER|||||||0.824||||||P-value is for HbA1c- at 24 weeks ≤6.5%.|Fisher Exact|||||||0.824
72599220|NCT01421147|144728718|SUPERIORITY_OR_OTHER|||||||0.385||||||P-value is for HbA1c- at 36 weeks \<7.0%.|Fisher Exact|||||||0.385
72599221|NCT01421147|144728718|SUPERIORITY_OR_OTHER|||||||0.408||||||P-value is for HbA1c- at 36 weeks ≤6.5%.|Fisher Exact|||||||0.408
72599222|NCT01421147|144728718|SUPERIORITY_OR_OTHER|||||||0.551||||||P-value is for HbA1c- at 52 weeks \<7.0%.|Fisher Exact|||||||0.551
72599223|NCT01421147|144728718|SUPERIORITY_OR_OTHER|||||||0.9||||||P-value is for HbA1c- at 52 weeks ≤6.5%.|Fisher Exact|||||||0.900
72599224|NCT01421147|144728718|SUPERIORITY_OR_OTHER|||||||0.646||||||P-value is for HbA1c- Endpoint, up to 24 weeks \<7.0%.|Fisher Exact|||||||0.646
72599225|NCT01421147|144728718|SUPERIORITY_OR_OTHER|||||||0.661||||||P-value is for HbA1c- Endpoint, up to 24 weeks ≤6.5%.|Fisher Exact|||||||0.661
72599226|NCT01421147|144728718|SUPERIORITY_OR_OTHER|||||||0.209||||||P-value is for HbA1c- Endpoint, up to 52 weeks \<7.0%.|Fisher Exact|||||||0.209
72599227|NCT01421147|144728718|SUPERIORITY_OR_OTHER|||||||0.54||||||P-value is for HbA1c- Endpoint, up to 52 weeks ≤6.5%.|Fisher Exact|||||||0.540
72599228|NCT01421147|144728719|SUPERIORITY_OR_OTHER|||||||0.703||||||P-value is for Total Events with BG ≤70 mg/dL,if available-24 wk.|Fisher Exact|||||||0.703
72599229|NCT01421147|144728719|SUPERIORITY_OR_OTHER|||||||0.495||||||P-value is for Total Events with BG ≤70 mg/dL,if available-52-wk.|Fisher Exact|||||||0.495
72599230|NCT01421147|144728719|SUPERIORITY_OR_OTHER|||||||0.174||||||P-value is for Severe Events-24 wk.|Fisher Exact|||||||0.174
72599231|NCT01421147|144728719|SUPERIORITY_OR_OTHER|||||||0.828||||||P-value is for Severe Events-52 wk.|Fisher Exact|||||||0.828
72599232|NCT01421147|144728719|SUPERIORITY_OR_OTHER|||||||0.661||||||P-value is for Nocturnal Events with BG ≤70 mg/dL-24 wk.|Fisher Exact|||||||0.661
72599233|NCT01421147|144728719|SUPERIORITY_OR_OTHER|||||||0.606||||||P-value is for Nocturnal Events with BG ≤70 mg/dL-52 wk.|Fisher Exact|||||||0.606
72599234|NCT01421147|144728720|SUPERIORITY_OR_OTHER|||||||0.717||||||P-value is for Total Events with BG ≤70 mg/dL, if available-24 wk.|Wilcoxon (Mann-Whitney)|||||||0.717
72599235|NCT01421147|144728720|SUPERIORITY_OR_OTHER|||||||0.163||||||P-value is for Severe Events-24 wk.|Wilcoxon (Mann-Whitney)|||||||0.163
72599236|NCT01421147|144728720|SUPERIORITY_OR_OTHER|||||||0.669||||||P-value is for Nocturnal Events with BG ≤70 mg/dL-24 wk.|Wilcoxon (Mann-Whitney)|||||||0.669
72599237|NCT01421147|144728720|SUPERIORITY_OR_OTHER|||||||0.738||||||P-value is for Total Events with BG ≤70 mg/dL, if available-52 wk.|Wilcoxon (Mann-Whitney)|||||||0.738
72599238|NCT01421147|144728720|SUPERIORITY_OR_OTHER|||||||0.826||||||P-value is for Severe Events-52 wk.|Wilcoxon (Mann-Whitney)|||||||0.826
72599239|NCT01421147|144728720|SUPERIORITY_OR_OTHER|||||||0.25||||||P-value is for Nocturnal Events with BG ≤70 mg/dL-52 wk.|Wilcoxon (Mann-Whitney)|||||||0.250
72599240|NCT03585712|144728849|OTHER|Is the overall mean change from baseline different from zero? Or did the infringement of schedule regardless the type of infringement lead to a change in mucus score?||||||0.26||||||P value from model testing intercept (does infringement change mucus score?) P-value from a repeated measures mixed model with the period, intervention, sequence and time (visit) as covariates. P-values ≤0.050 are considered significant|Mixed Models Analysis|||"Mixed model for repeated measures using as response delta to Day41, delta to Day42, delta to Day70 and delta to Day71.~Covariates: period, intervention (missed pill or delayed pill), sequence of intervention (missed pill then delayed pill and vice versa), time and subject.~Subject as random effect + time repeated effect within each combination subject\* period"||||0.26
72599241|NCT03585712|144728850|OTHER||||||>|0.999||||||p values \> 0.050 (Not Statistically significant)|McNemar|McNemar test comparing agreement in the missed and delayed periods||Absence of risk increase||||>0.999
72599242|NCT03585712|144728850|OTHER|||||||0.655||||||p values \> 0.050 (Not Statistically significant)|McNemar|McNemar test comparing agreement in the missed and delayed periods||Transient risk increase||||0.655
72599243|NCT03585712|144728850|OTHER|||||||0.317||||||p values \> 0.050 (Not Statistically significant)|McNemar|McNemar test comparing agreement in the missed and delayed periods||Prolonged risk increase||||0.317
72599244|NCT03585712|144728851|OTHER||||||<|0.001||||||Indicates significance at the 0.05 level (p-value ≤ 0.05)|McNemar|P-value from an exact kappa test comparing agreement of ovarian status vs the reported perfect use period||A stratified McNemar test (stratification on the site, AGREE option in SAS) was used to compare the distribution of ovarian activity classification in the perfect use period to the delayed and missed pill periods (pairwise vs perfect use). The worst (meaning most risk of ovulation) ovarian activity category in the period was used for the analyses.||||<0.001
72599245|NCT03585712|144728851|OTHER||||||<|0.001||||||Indicates significance at the 0.05 level (p-value ≤ 0.05)|McNemar|P-value from an exact kappa test comparing agreement of ovarian status vs the reported perfect use period.||A stratified McNemar test (stratification on the site, AGREE option in SAS) was used to compare the distribution of ovarian activity classification in the perfect use period to the delayed and missed pill periods (pairwise vs perfect use). The worst (meaning most risk of ovulation) ovarian activity category in the period was used for the analyses.||||<0.001
72599246|NCT03585712|144728852|OTHER|||||||0.127|||||||McNemar|P-value from an exact kappa test comparing agreement of cervical mucus score classification vs the reported perfect use period||Stratified McNemar test (stratification on the site, AGREE option in SAS) to compare the distribution of cervical mucus scores in the perfect use period to the delayed and missed pill periods (pairwise vs perfect use).||||0.127
72599247|NCT03585712|144728852|OTHER|||||||0.018||||||\* Indicates significance at the 0.05 level (p-value ≤ 0.05).|McNemar|P-value from an exact kappa test comparing agreement of cervical mucus score classification vs the reported perfect use period.||Stratified McNemar test (stratification on the site, AGREE option in SAS) to compare the distribution of cervical mucus scores in the perfect use period to the delayed and missed pill periods (pairwise vs perfect use).||||0.018
72599248|NCT03004924|144728859|SUPERIORITY||Difference in response rate|7.7||||0.127|TWO_SIDED|95.0|-1.6|16.9|||Fisher Exact|||||16.9|-1.6|0.127
72599249|NCT03004924|144728860|SUPERIORITY||Difference in response rate|-3.5||||0.5|TWO_SIDED|95.0|-12.8|5.9|||Fisher Exact|||||5.9|-12.8|0.500
72599250|NCT04677387|144728878|SUPERIORITY||Mean Difference (Final Values)|-0.00325||||0.473|TWO_SIDED||||||Regression, Linear|Linear regression using a Generalized Estimating Equation (GEE) model clustering on pharmacy.||||||0.473
72599251|NCT04677387|144728879|SUPERIORITY|||||||0.007|||||||Regression, Linear|Linear regression with Generalized Estimating Equation (GEE) model.||||||.007
72599252|NCT04677387|144728880|SUPERIORITY|||||||0.002|||||||Regression, Linear|Linear regression with a Generalized Estimating Equation (GEE) model.||||||.002
72599253|NCT04677387|144728881|SUPERIORITY|||||||0.169|||||||Regression, Linear|Linear regression with Generalized Estimating Equation (GEE) model.||||||0.169
72599254|NCT01964716|144728884|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for a given antibody was demonstrated if the lower bound of the 2-sided, 97.5% confidence interval, computed using the Chan and Zhang procedure, for the difference in proportions (13vPnC MDV - 13vPnC SDS) was greater than -0.10.|percent difference|-0.8|||||TWO_SIDED|97.5|-3.4|1.2||||||Serotype 1: Exact 2-sided confidence interval (based on Chan and Zhang) for the difference in proportions, 13vPnC MDV - 13vPnC SDS, expressed as a percentage was analyzed.||1.2|-3.4|
72599255|NCT01964716|144728884|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for a given antibody was demonstrated if the lower bound of the 2-sided, 97.5% confidence interval, computed using the Chan and Zhang procedure, for the difference in proportions (13vPnC MDV - 13vPnC SDS) was greater than -0.10.|percent difference|-0.8|||||TWO_SIDED|97.5|-3.7|1.6||||||Serotype 3: Exact 2-sided confidence interval (based on Chan and Zhang) for the difference in proportions, 13vPnC MDV - 13vPnC SDS, expressed as a percentage was analyzed.||1.6|-3.7|
72599256|NCT01964716|144728884|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for a given antibody was demonstrated if the lower bound of the 2-sided, 97.5% confidence interval, computed using the Chan and Zhang procedure, for the difference in proportions (13vPnC MDV - 13vPnC SDS) was greater than -0.10.|percent difference|0.0|||||TWO_SIDED|97.5|-2.3|2.4||||||Serotype 4: Exact 2-sided confidence interval (based on Chan and Zhang) for the difference in proportions, 13vPnC MDV - 13vPnC SDS, expressed as a percentage was analyzed.||2.4|-2.3|
72421616|NCT03720938|144354385|SUPERIORITY|||||||0.60938||||||The outcome of self-perception for sports competence was tested for any difference between groups by linear mixed-effects model analysis.|Linear mixed-effects model|Adjusted by Satterthwaite's degrees of freedom method for cluster effect, and small sample sizes in addition to baseline value and age.||Null hypothesis was the absence of difference between the two groups for the dependent variable self-perception of sports competence.||||0.60938
72599257|NCT01964716|144728884|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for a given antibody was demonstrated if the lower bound of the 2-sided, 97.5% confidence interval, computed using the Chan and Zhang procedure, for the difference in proportions (13vPnC MDV - 13vPnC SDS) was greater than -0.10.|percent difference|-1.2|||||TWO_SIDED|97.5|-5.4|2.8||||||Serotype 5: Exact 2-sided confidence interval (based on Chan and Zhang) for the difference in proportions, 13vPnC MDV - 13vPnC SDS, expressed as a percentage was analyzed.||2.8|-5.4|
72599258|NCT01964716|144728884|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for a given antibody was demonstrated if the lower bound of the 2-sided, 97.5% confidence interval, computed using the Chan and Zhang procedure, for the difference in proportions (13vPnC MDV - 13vPnC SDS) was greater than -0.10.|percent difference|-1.2|||||TWO_SIDED|97.5|-5.3|2.6||||||Serotype 6A: Exact 2-sided confidence interval (based on Chan and Zhang) for the difference in proportions, 13vPnC MDV - 13vPnC SDS, expressed as a percentage was analyzed.||2.6|-5.3|
72599259|NCT01964716|144728884|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for a given antibody was demonstrated if the lower bound of the 2-sided, 97.5% confidence interval, computed using the Chan and Zhang procedure, for the difference in proportions (13vPnC MDV - 13vPnC SDS) was greater than -0.10.|percent difference|0.0|||||TWO_SIDED|97.5|-4.7|4.7||||||Serotype 6B: Exact 2-sided confidence interval (based on Chan and Zhang) for the difference in proportions, 13vPnC MDV - 13vPnC SDS, expressed as a percentage was analyzed.||4.7|-4.7|
72599260|NCT01964716|144728884|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for a given antibody was demonstrated if the lower bound of the 2-sided, 97.5% confidence interval, computed using the Chan and Zhang procedure, for the difference in proportions (13vPnC MDV - 13vPnC SDS) was greater than -0.10.|percent difference|-0.4|||||TWO_SIDED|97.5|-2.7|1.6||||||Serotype 7F: Exact 2-sided confidence interval (based on Chan and Zhang) for the difference in proportions, 13vPnC MDV - 13vPnC SDS, expressed as a percentage was analyzed.||1.6|-2.7|
72599261|NCT01964716|144728884|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for a given antibody was demonstrated if the lower bound of the 2-sided, 97.5% confidence interval, computed using the Chan and Zhang procedure, for the difference in proportions (13vPnC MDV - 13vPnC SDS) was greater than -0.10.|percent difference|-0.4|||||TWO_SIDED|97.5|-3.8|2.8||||||Serotype 9V: Exact 2-sided confidence interval (based on Chan and Zhang) for the difference in proportions, 13vPnC MDV - 13vPnC SDS, expressed as a percentage was analyzed.||2.8|-3.8|
72599262|NCT01964716|144728884|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for a given antibody was demonstrated if the lower bound of the 2-sided, 97.5% confidence interval, computed using the Chan and Zhang procedure, for the difference in proportions (13vPnC MDV - 13vPnC SDS) was greater than -0.10.|percent difference|-0.8|||||TWO_SIDED|97.5|-4.3|2.5||||||Serotype 14: Exact 2-sided confidence interval (based on Chan and Zhang) for the difference in proportions, 13vPnC MDV - 13vPnC SDS, expressed as a percentage was analyzed.||2.5|-4.3|
72599263|NCT01964716|144728884|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for a given antibody was demonstrated if the lower bound of the 2-sided, 97.5% confidence interval, computed using the Chan and Zhang procedure, for the difference in proportions (13vPnC MDV - 13vPnC SDS) was greater than -0.10.|percent difference|1.2|||||TWO_SIDED|97.5|-1.6|4.5||||||Serotype 18C: Exact 2-sided confidence interval (based on Chan and Zhang) for the difference in proportions, 13vPnC MDV - 13vPnC SDS, expressed as a percentage was analyzed.||4.5|-1.6|
72599264|NCT01964716|144728884|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for a given antibody was demonstrated if the lower bound of the 2-sided, 97.5% confidence interval, computed using the Chan and Zhang procedure, for the difference in proportions (13vPnC MDV - 13vPnC SDS) was greater than -0.10.|percent difference|0.8|||||TWO_SIDED|97.5|-1.6|3.6||||||Serotype 19A: Exact 2-sided confidence interval (based on Chan and Zhang) for the difference in proportions, 13vPnC MDV - 13vPnC SDS, expressed as a percentage was analyzed.||3.6|-1.6|
72599265|NCT01964716|144728884|SUPERIORITY_OR_OTHER||percentage difference|-0.4|||||TWO_SIDED|97.5|-4.4|3.5||||||Serotype 19F: Exact 2-sided confidence interval (based on Chan \& Zhang) for the difference in proportions, 13vPnC multidose vial (MDV) - 13vPnC single-dose syringe (SDS), expressed as a percentage was analyzed.||3.5|-4.4|
72599266|NCT01964716|144728884|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for a given antibody was demonstrated if the lower bound of the 2-sided, 97.5% confidence interval, computed using the Chan and Zhang procedure, for the difference in proportions (13vPnC MDV - 13vPnC SDS) was greater than -0.10.|percent difference|0.0|||||TWO_SIDED|97.5|-4.3|4.4||||||Serotype 23F: Exact 2-sided confidence interval (based on Chan and Zhang) for the difference in proportions, 13vPnC MDV - 13vPnC SDS, expressed as a percentage was analyzed.||4.4|-4.3|
72599267|NCT01964716|144728885|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for a given antibody serotype was declared if lower bound of the 2-sided, 97.5% confidence interval for the geometric mean concentration ratio (GMC MDV /GMC SDS) was greater than 0.5 (2-fold criterion).|GMC Ratio|1.03|||||TWO_SIDED|97.5|0.87|1.22||||||Serotype 1: Ratio of GMCs, MDV to SDS, was calculated by back transforming the mean difference between the vaccine groups on the logarithmic scale; CIs for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC MDV - 13vPnC SDS).||1.22|0.87|
72599268|NCT01964716|144728885|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for a given antibody serotype was declared if lower bound of the 2-sided, 97.5% confidence interval for the geometric mean concentration ratio (GMC MDV /GMC SDS) was greater than 0.5 (2-fold criterion).|GMC Ratio|0.79|||||TWO_SIDED|97.5|0.71|0.9||||||Serotype 3: Ratio of GMCs, MDV to SDS, was calculated by back transforming the mean difference between the vaccine groups on the logarithmic scale; CIs for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC MDV - 13vPnC SDS).||0.90|0.71|
72599269|NCT01964716|144728885|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for a given antibody serotype was declared if lower bound of the 2-sided, 97.5% confidence interval for the geometric mean concentration ratio (GMC MDV /GMC SDS) was greater than 0.5 (2-fold criterion).|GMC Ratio|1.0|||||TWO_SIDED|97.5|0.86|1.18||||||Serotype 4: Ratio of GMCs, MDV to SDS, was calculated by back transforming the mean difference between the vaccine groups on the logarithmic scale; CIs for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC MDV - 13vPnC SDS).||1.18|0.86|
72599270|NCT01964716|144728885|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for a given antibody serotype was declared if lower bound of the 2-sided, 97.5% confidence interval for the geometric mean concentration ratio (GMC MDV /GMC SDS) was greater than 0.5 (2-fold criterion).|GMC Ratio|1.01|||||TWO_SIDED|97.5|0.85|1.19||||||Serotype 5: Ratio of GMCs, MDV to SDS, was calculated by back transforming the mean difference between the vaccine groups on the logarithmic scale; CIs for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC MDV - 13vPnC SDS).||1.19|0.85|
72599271|NCT01964716|144728885|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for a given antibody serotype was declared if lower bound of the 2-sided, 97.5% confidence interval for the geometric mean concentration ratio (GMC MDV /GMC SDS) was greater than 0.5 (2-fold criterion).|GMC Ratio|1.03|||||TWO_SIDED|97.5|0.86|1.22||||||Serotype 6A: Ratio of GMCs, MDV to SDS, was calculated by back transforming the mean difference between the vaccine groups on the logarithmic scale; CIs for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC MDV - 13vPnC SDS).||1.22|0.86|
72599272|NCT01964716|144728885|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for a given antibody serotype was declared if lower bound of the 2-sided, 97.5% confidence interval for the geometric mean concentration ratio (GMC MDV /GMC SDS) was greater than 0.5 (2-fold criterion).|GMC Ratio|1.06|||||TWO_SIDED|97.5|0.82|1.36||||||Serotype 6B: Ratio of GMCs, MDV to SDS, was calculated by back transforming the mean difference between the vaccine groups on the logarithmic scale; CIs for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC MDV - 13vPnC SDS).||1.36|0.82|
72599273|NCT01964716|144728885|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for a given antibody serotype was declared if lower bound of the 2-sided, 97.5% confidence interval for the geometric mean concentration ratio (GMC MDV /GMC SDS) was greater than 0.5 (2-fold criterion).|GMC Ratio|0.94|||||TWO_SIDED|97.5|0.82|1.08||||||Serotype 7F: Ratio of GMCs, MDV to SDS, was calculated by back transforming the mean difference between the vaccine groups on the logarithmic scale; CIs for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC MDV - 13vPnC SDS).||1.08|0.82|
72599274|NCT01964716|144728885|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for a given antibody serotype was declared if lower bound of the 2-sided, 97.5% confidence interval for the geometric mean concentration ratio (GMC MDV /GMC SDS) was greater than 0.5 (2-fold criterion).|GMC Ratio|1.03|||||TWO_SIDED|97.5|0.87|1.21||||||Serotype 9V: Ratio of GMCs, MDV to SDS, was calculated by back transforming the mean difference between the vaccine groups on the logarithmic scale; CIs for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC MDV - 13vPnC SDS).||1.21|0.87|
72599275|NCT01964716|144728885|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for a given antibody serotype was declared if lower bound of the 2-sided, 97.5% confidence interval for the geometric mean concentration ratio (GMC MDV /GMC SDS) was greater than 0.5 (2-fold criterion).|GMC Ratio|0.96|||||TWO_SIDED|97.5|0.75|1.24||||||Serotype 14: Ratio of GMCs, MDV to SDS, was calculated by back transforming the mean difference between the vaccine groups on the logarithmic scale; CIs for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC MDV - 13vPnC SDS).||1.24|0.75|
72421617|NCT03720938|144354386|SUPERIORITY|||||||0.094||||||The outcome of self-perception for physical condition competence was tested for any difference between groups by covariate analysis.|ANCOVA|Adjusted for self-perception for physical condition competence at baseline and confounding variable age.||Null hypothesis was the absence of difference between the two groups for the dependent variable self-perception of physical condition competence.||||0.094
72599276|NCT01964716|144728885|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for a given antibody serotype was declared if lower bound of the 2-sided, 97.5% confidence interval for the geometric mean concentration ratio (GMC MDV /GMC SDS) was greater than 0.5 (2-fold criterion).|GMC Ratio|1.28|||||TWO_SIDED|97.5|1.09|1.49||||||Serotype 18C: Ratio of GMCs, MDV to SDS, was calculated by back transforming the mean difference between the vaccine groups on the logarithmic scale; CIs for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC MDV - 13vPnC SDS).||1.49|1.09|
72599277|NCT01964716|144728885|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for a given antibody serotype was declared if lower bound of the 2-sided, 97.5% confidence interval for the geometric mean concentration ratio (GMC MDV /GMC SDS) was greater than 0.5 (2-fold criterion).|GMC Ratio|1.01|||||TWO_SIDED|97.5|0.82|1.24||||||Serotype 19A: Ratio of GMCs, MDV to SDS, was calculated by back transforming the mean difference between the vaccine groups on the logarithmic scale; CIs for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC MDV - 13vPnC SDS).||1.24|0.82|
72599278|NCT01964716|144728885|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for a given antibody serotype was declared if lower bound of the 2-sided, 97.5% confidence interval for the geometric mean concentration ratio (GMC MDV /GMC SDS) was greater than 0.5 (2-fold criterion).|GMC Ratio|1.04|||||TWO_SIDED|97.5|0.85|1.26||||||Serotype 19F: Ratio of GMCs, MDV to SDS, was calculated by back transforming the mean difference between the vaccine groups on the logarithmic scale; CIs for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC MDV - 13vPnC SDS).||1.26|0.85|
72599279|NCT01964716|144728885|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for a given antibody serotype was declared if lower bound of the 2-sided, 97.5% confidence interval for the geometric mean concentration ratio (GMC MDV /GMC SDS) was greater than 0.5 (2-fold criterion).|GMC Ratio|1.2|||||TWO_SIDED|97.5|0.98|1.48||||||Serotype 23F: Ratio of GMCs, MDV to SDS, was calculated by back transforming the mean difference between the vaccine groups on the logarithmic scale; CIs for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC MDV - 13vPnC SDS).||1.48|0.98|
72599280|NCT01964716|144728894|SUPERIORITY_OR_OTHER||percent difference|-7.7|||||TWO_SIDED|95.0|-17.2|1.9||||||Serotype 1: Exact 2-sided confidence interval (based on Chan and Zhang) for the difference in proportions, 13vPnC MDV - 13vPnC SDS, expressed as a percentage was analyzed.||1.9|-17.2|
72599281|NCT01964716|144728894|SUPERIORITY_OR_OTHER||percent difference|-1.2|||||TWO_SIDED|95.0|-4.4|1.1||||||Serotype 3: Exact 2-sided confidence interval (based on Chan and Zhang) for the difference in proportions, 13vPnC MDV - 13vPnC SDS, expressed as a percentage was analyzed.||1.1|-4.4|
72599282|NCT01964716|144728894|SUPERIORITY_OR_OTHER||percent difference|0.0|||||TWO_SIDED|95.0|-2.3|2.3||||||Serotype 4: Exact 2-sided confidence interval (based on Chan and Zhang) for the difference in proportions, 13vPnC MDV - 13vPnC SDS, expressed as a percentage was analyzed.||2.3|-2.3|
72599283|NCT01964716|144728894|SUPERIORITY_OR_OTHER||percent difference|-2.4|||||TWO_SIDED|95.0|-10.6|5.7||||||Serotype 5: Exact 2-sided confidence interval (based on Chan and Zhang) for the difference in proportions, 13vPnC MDV - 13vPnC SDS, expressed as a percentage was analyzed.||5.7|-10.6|
72599284|NCT01964716|144728894|SUPERIORITY_OR_OTHER||percent difference|0.0|||||TWO_SIDED|95.0|-2.9|2.8||||||Serotype 6A: Exact 2-sided confidence interval (based on Chan and Zhang) for the difference in proportions, 13vPnC MDV - 13vPnC SDS, expressed as a percentage was analyzed.||2.8|-2.9|
72599285|NCT01964716|144728894|SUPERIORITY_OR_OTHER||percent difference|0.0|||||TWO_SIDED|95.0|-4.5|4.6||||||Serotype 6B: Exact 2-sided confidence interval (based on Chan and Zhang) for the difference in proportions, 13vPnC MDV - 13vPnC SDS, expressed as a percentage was analyzed.||4.6|-4.5|
72599286|NCT01964716|144728894|SUPERIORITY_OR_OTHER||percent difference|0.0|||||TWO_SIDED|95.0|-2.3|2.3||||||Serotype 7F: Exact 2-sided confidence interval (based on Chan and Zhang) for the difference in proportions, 13vPnC MDV - 13vPnC SDS, expressed as a percentage was analyzed.||2.3|-2.3|
72599287|NCT01964716|144728894|SUPERIORITY_OR_OTHER||percent difference|4.7|||||TWO_SIDED|95.0|-4.5|14.1||||||Serotype 9V: Exact 2-sided confidence interval (based on Chan and Zhang) for the difference in proportions, 13vPnC MDV - 13vPnC SDS, expressed as a percentage was analyzed.||14.1|-4.5|
72599288|NCT01964716|144728894|SUPERIORITY_OR_OTHER||percent difference|-7.8|||||TWO_SIDED|95.0|-15.8|0.0||||||Serotype 14: Exact 2-sided confidence interval (based on Chan and Zhang) for the difference in proportions, 13vPnC MDV - 13vPnC SDS, expressed as a percentage was analyzed.||-0.0|-15.8|
72421618|NCT03720938|144354386|SUPERIORITY|||||||0.085||||||The outcome of self-perception for physical condition competence was tested for any difference between groups by linear mixed-effects model analysis.|Linear mixed effects model|Adjusted for cluster effect in addition to baseline value and age.||Null hypothesis was the absence of difference between the two groups for the dependent variable self-perception of physical condition competence.||||0.085
72599289|NCT01964716|144728894|SUPERIORITY_OR_OTHER||percent difference|0.0|||||TWO_SIDED|95.0|-2.9|2.9||||||Serotype 18C: Exact 2-sided confidence interval (based on Chan and Zhang) for the difference in proportions, 13vPnC MDV - 13vPnC SDS, expressed as a percentage was analyzed.||2.9|-2.9|
72599290|NCT01964716|144728894|SUPERIORITY_OR_OTHER||percent difference|-1.9|||||TWO_SIDED|95.0|-6.6|2.4||||||Serotype 19A: Exact 2-sided confidence interval (based on Chan and Zhang) for the difference in proportions, 13vPnC MDV - 13vPnC SDS, expressed as a percentage was analyzed.||2.4|-6.6|
72599291|NCT01964716|144728894|SUPERIORITY_OR_OTHER||percent difference|-0.7|||||TWO_SIDED|95.0|-6.3|4.9||||||Serotype 19F: Exact 2-sided confidence interval (based on Chan and Zhang) for the difference in proportions, 13vPnC MDV - 13vPnC SDS, expressed as a percentage was analyzed.||4.9|-6.3|
72599292|NCT01964716|144728894|SUPERIORITY_OR_OTHER||percent difference|-1.3|||||TWO_SIDED|95.0|-5.8|3.0||||||Serotype 23F: Exact 2-sided confidence interval (based on Chan and Zhang) for the difference in proportions, 13vPnC MDV - 13vPnC SDS, expressed as a percentage was analyzed.||3.0|-5.8|
72599293|NCT01964716|144728895|SUPERIORITY_OR_OTHER||GMT Ratio|0.9|||||TWO_SIDED|95.0|0.7|1.2||||||Serotype 1: Ratio of GMTs, MDV to SDS, was calculated by back transforming the mean difference between the vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC MDV - 13vPnC SDS).||1.20|0.70|
72599294|NCT01964716|144728895|SUPERIORITY_OR_OTHER||GMT Ratio|0.8|||||TWO_SIDED|95.0|0.69|0.93||||||Serotype 3: Ratio of GMTs, MDV to SDS, was calculated by back transforming the mean difference between the vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC MDV - 13vPnC SDS).||0.93|0.69|
72599295|NCT01964716|144728895|SUPERIORITY_OR_OTHER||GMT Ratio|1.1|||||TWO_SIDED|95.0|0.89|1.39||||||Serotype 4: Ratio of GMTs, MDV to SDS, was calculated by back transforming the mean difference between the vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC MDV - 13vPnC SDS).||1.39|0.89|
72599296|NCT01964716|144728895|SUPERIORITY_OR_OTHER||GMT Ratio|1.0|||||TWO_SIDED|95.0|0.8|1.22||||||Serotype 5: Ratio of GMTs, MDV to SDS, was calculated by back transforming the mean difference between the vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC MDV - 13vPnC SDS).||1.22|0.80|
72599297|NCT01964716|144728895|SUPERIORITY_OR_OTHER||GMT Ratio|0.9|||||TWO_SIDED|95.0|0.7|1.06||||||Serotype 6A: Ratio of GMTs, MDV to SDS, was calculated by back transforming the mean difference between the vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC MDV - 13vPnC SDS).||1.06|0.70|
72599298|NCT01964716|144728895|SUPERIORITY_OR_OTHER||GMT Ratio|1.0|||||TWO_SIDED|95.0|0.74|1.33||||||Serotype 6B: Ratio of GMTs, MDV to SDS, was calculated by back transforming the mean difference between the vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC MDV - 13vPnC SDS).||1.33|0.74|
72599299|NCT01964716|144728895|SUPERIORITY_OR_OTHER||GMT Ratio|0.8|||||TWO_SIDED|95.0|0.7|1.0||||||Serotype 7F: Ratio of GMTs, MDV to SDS, was calculated by back transforming the mean difference between the vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC MDV - 13vPnC SDS).||1.00|0.70|
72421619|NCT03720938|144354386|SUPERIORITY|||||||0.08818||||||Linear mixed-effects model fit by maximum likelihood since restricted maximum likelihood assumes a strong normality.|Linear mixed-effects model|Adjusted by Satterthwaite's degrees of freedom method for cluster effect, and small sample sizes in addition to baseline value and age.||The outcome of self-perception for sports competence was tested for any difference between groups by linear mixed-effects model analysis.||||0.08818
72599300|NCT01964716|144728895|SUPERIORITY_OR_OTHER||GMT Ratio|1.0|||||TWO_SIDED|95.0|0.79|1.27||||||Serotype 9V: Ratio of GMTs, MDV to SDS, was calculated by back transforming the mean difference between the vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC MDV - 13vPnC SDS).||1.27|0.79|
72599301|NCT01964716|144728895|SUPERIORITY_OR_OTHER||GMT Ratio|0.7|||||TWO_SIDED|95.0|0.48|1.08||||||Serotype 14: Ratio of GMTs, MDV to SDS, was calculated by back transforming the mean difference between the vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC MDV - 13vPnC SDS).||1.08|0.48|
72599302|NCT01964716|144728895|SUPERIORITY_OR_OTHER||GMT Ratio|1.7|||||TWO_SIDED|95.0|1.38|2.19||||||Serotype 18C: Ratio of GMTs, MDV to SDS, was calculated by back transforming the mean difference between the vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC MDV - 13vPnC SDS).||2.19|1.38|
72599303|NCT01964716|144728895|SUPERIORITY_OR_OTHER||GMT Ratio|0.9|||||TWO_SIDED|95.0|0.74|1.16||||||Serotype 19A: Ratio of GMTs, MDV to SDS, was calculated by back transforming the mean difference between the vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC MDV - 13vPnC SDS).||1.16|0.74|
72599304|NCT01964716|144728895|SUPERIORITY_OR_OTHER||GMT Ratio|0.9|||||TWO_SIDED|95.0|0.71|1.18||||||Serotype 19F: Ratio of GMTs, MDV to SDS, was calculated by back transforming the mean difference between the vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC MDV - 13vPnC SDS).||1.18|0.71|
72599305|NCT01964716|144728895|SUPERIORITY_OR_OTHER||GMT Ratio|0.9|||||TWO_SIDED|95.0|0.67|1.25||||||Serotype 23F: Ratio of GMTs, MDV to SDS, was calculated by back transforming the mean difference between the vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC MDV - 13vPnC SDS).||1.25|0.67|
72599306|NCT00822328|144728929|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||ANOVA|||Bacterial colonies were counted for study group and placebo group on week 0, 1, 2, 3, 4, 5, 6. Significant differences between both experimental groups at the same time were determined with one-way ANOVA (significance level p = 0.05).||||<0.05
72599307|NCT00822328|144728931|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||ANOVA|||Bacterial colonies were counted for study group and placebo group on week 0, 1, 2, 3, 4, 5, 6. Significant differences between both experimental groups at the same time were determined with one-way ANOVA (significance level p = 0.05).||||<0.05
72599308|NCT01215435|144728954|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was considered confirmed if the upper bound of the two-sided 95% confidence interval for the mean HbA1c treatment difference was below or equal to 0.4%. This is equivalent to using a one-sided test of size 2.5%.|Estimated treatment difference, Mean|-0.14|||<|0.001||95.0|-0.4|0.13|||Regression, Linear|||H0: D \> 0.4% against H1: D ≤ 0.4% where D is the mean treatment difference for change in HbA1c (pre-breakfast OD minus pre-dinner OD)||0.13|-0.40|<0.001
72599309|NCT01215435|144728955|SUPERIORITY_OR_OTHER||Estimated treatment difference, Mean|-3.14||||0.6215||95.0|-15.65|9.37|||Regression, Linear|||||9.37|-15.65|0.6215
72599310|NCT05811026|144728972|SUPERIORITY||Median Difference (Net)|5.0||||0.075|TWO_SIDED|||||Statistical significance was defined as a p-value \< 0.05.|Wilcoxon (Mann-Whitney)||Differece = (2-week interval group) - (4-week interval group)|||||0.075
72599311|NCT05811026|144728973|SUPERIORITY||Median Difference (Net)|0.17||||0.4727|TWO_SIDED|||||Statistical significance was defined as a p-value \< 0.05.|Wilcoxon (Mann-Whitney)||Differece = (2-week interval group) - (4-week interval group)|||||0.4727
72599312|NCT05811026|144728974|SUPERIORITY||Median Difference (Net)|-1.5||||0.7326|TWO_SIDED|||||Statistical significance was defined as a p-value \< 0.05.|Wilcoxon (Mann-Whitney)||Differece = (2-week interval group) - (4-week interval group)|||||0.7326
72599313|NCT05811026|144728975|SUPERIORITY||Median Difference (Net)|0.61||||0.0757|TWO_SIDED|||||Statistical significance was defined as a p-value \< 0.05.|Wilcoxon (Mann-Whitney)||Differece = (2-week interval group) - (4-week interval group)|||||0.0757
72599314|NCT05811026|144728976|SUPERIORITY||Median Difference (Net)|37.75||||0.0376|TWO_SIDED|||||Statistical significance was defined as a p-value \< 0.05.|Wilcoxon (Mann-Whitney)||Differece = (2-week interval group) - (4-week interval group)|||||0.0376
72599315|NCT05811026|144728977|SUPERIORITY||Median Difference (Final Values)|-0.17||||0.3123|TWO_SIDED|||||Statistical significance was defined as a p-value \< 0.05.|Wilcoxon (Mann-Whitney)||Differece = (2-week interval group) - (4-week interval group)|||||0.3123
72599316|NCT05811026|144728978|SUPERIORITY||Median Difference (Final Values)|1.0||||0.1009|TWO_SIDED|||||Statistical significance was defined as a p-value \< 0.05.|Wilcoxon (Mann-Whitney)||Differece = (2-week interval group) - (4-week interval group)|||||0.1009
72599317|NCT05811026|144728979|SUPERIORITY||Mean Difference (Net)|5.5||||0.0088|TWO_SIDED|||||Statistical significance was defined as a p-value \< 0.05.|Wilcoxon (Mann-Whitney)||Differece = (2-week interval group) - (4-week interval group)|||||0.0088
72599318|NCT05811026|144728980|SUPERIORITY||Median Difference (Net)|-0.03||||0.4274|TWO_SIDED|||||Statistical significance was defined as a p-value \< 0.05.|Wilcoxon (Mann-Whitney)||Differece = (2-week interval group) - (4-week interval group)|||||0.4274
72599319|NCT05811026|144728981|SUPERIORITY||Mean Difference (Net)|1.75||||0.6497|TWO_SIDED|||||Statistical significance was defined as a p-value \< 0.05.|Wilcoxon (Mann-Whitney)||Differece = (2-week interval group) - (4-week interval group)|||||0.6497
72599320|NCT05811026|144728982|SUPERIORITY||Median Difference (Net)|0.54||||0.0006|TWO_SIDED|||||Statistical significance was defined as a p-value \< 0.05.|Wilcoxon (Mann-Whitney)||Differece = (2-week interval group) - (4-week interval group)|||||0.0006
72599321|NCT05811026|144728983|SUPERIORITY||Median Difference (Net)|34.5||||0.0002|TWO_SIDED|||||Statistical significance was defined as a p-value \< 0.05.|Wilcoxon (Mann-Whitney)||Differece = (2-week interval group) - (4-week interval group)|||||0.0002
72599322|NCT05811026|144728984|SUPERIORITY||Median Difference (Final Values)|0.0||||0.6231|TWO_SIDED|||||Statistical significance was defined as a p-value \< 0.05.|Wilcoxon (Mann-Whitney)||Differece = (2-week interval group) - (4-week interval group)|||||0.6231
72599323|NCT05811026|144728985|SUPERIORITY||Median Difference (Final Values)|0.0||||0.3327|TWO_SIDED|||||Statistical significance was defined as a p-value \< 0.05.|Wilcoxon (Mann-Whitney)||Differece = (2-week interval group) - (4-week interval group)|||||0.3327
72599324|NCT05811026|144728986|SUPERIORITY||Median Difference (Net)|7.25||||0.0752|TWO_SIDED|||||Statistical significance was defined as a p-value \< 0.05.|Wilcoxon (Mann-Whitney)||Differece = (2-week interval group) - (4-week interval group)|||||0.0752
72599325|NCT05811026|144728987|SUPERIORITY||Median Difference (Net)|-0.94||||0.0982|TWO_SIDED|||||Statistical significance was defined as a p-value \< 0.05.|Wilcoxon (Mann-Whitney)||Differece = (2-week interval group) - (4-week interval group)|||||0.0982
72599326|NCT05811026|144728988|SUPERIORITY||Median Difference (Net)|-0.5||||0.8541|TWO_SIDED|||||Statistical significance was defined as a p-value \< 0.05.|Wilcoxon (Mann-Whitney)||Differece = (2-week interval group) - (4-week interval group)|||||0.8541
72599327|NCT05811026|144728989|SUPERIORITY||Median Difference (Net)|0.63||||0.0758|TWO_SIDED|||||Statistical significance was defined as a p-value \< 0.05.|Wilcoxon (Mann-Whitney)||Differece = (2-week interval group) - (4-week interval group)|||||0.0758
72599328|NCT05811026|144728990|SUPERIORITY||Median Difference (Net)|41.75||||0.066|TWO_SIDED|||||Statistical significance was defined as a p-value \< 0.05.|Wilcoxon (Mann-Whitney)||Differece = (2-week interval group) - (4-week interval group)|||||0.066
72599329|NCT05811026|144728991|SUPERIORITY||Median Difference (Final Values)|-0.17||||0.6961|TWO_SIDED|||||Statistical significance was defined as a p-value \< 0.05.|Wilcoxon (Mann-Whitney)||Differece = (2-week interval group) - (4-week interval group)|||||0.6961
72599330|NCT05811026|144728992|SUPERIORITY||Median Difference (Final Values)|1.0||||0.0067|TWO_SIDED|||||Statistical significance was defined as a p-value \< 0.05.|Wilcoxon (Mann-Whitney)||Differece = (2-week interval group) - (4-week interval group)|||||0.0067
72599331|NCT02870205|144728994|SUPERIORITY||||||<|0.001||||||GSP 301 NS vs GSP 301 placebo NS comparison for rTNSS was tested at 0.05 significance level.|ANCOVA|||||||<0.001
72599332|NCT02870205|144728994|SUPERIORITY|||||||0.028|||||||ANCOVA|||||||0.028
72599333|NCT02870205|144728994|SUPERIORITY|||||||0.019|||||||ANCOVA|||||||0.019
72599334|NCT02870205|144728994|SUPERIORITY||||||<|0.001|||||||ANCOVA|||||||<0.001
72599335|NCT02870205|144728994|SUPERIORITY|||||||0.002|||||||ANCOVA|||||||0.002
72599336|NCT02179749|144729002|SUPERIORITY||Mean Difference (Final Values)|0.52|STANDARD_ERROR_OF_MEAN|0.2||0.51|TWO_SIDED||||||ANOVA|||||||0.51
72599337|NCT02179749|144729002|SUPERIORITY||Slope|0.08|STANDARD_ERROR_OF_MEAN|0.04||0.038|TWO_SIDED||||||Mixed Models Analysis|||Latent growth model includes one week on study drug and two weeks after the last dose of study drug. Principal predictors were drug plasma concentration and baseline treatment goal of abstinence or non abstinence. Arms were combined for this analysis.||||0.038
72599338|NCT02179749|144729003|SUPERIORITY||Mean Difference (Final Values)|0.15|STANDARD_ERROR_OF_MEAN|36.7||0.5|TWO_SIDED||||||ANOVA|411 and 102 degrees of freedom||||||0.50
72599339|NCT02756364|144729024|SUPERIORITY||Hazard Ratio (HR)|0.77||||0.537|TWO_SIDED|95.0|0.47|1.26|||Log Rank||HR obtained by stratified Cox proportional hazard model with treatment arm, original interactive response technology (IRT) stratification factors as covariates. A hazard ratio of \<1 was considered statistically significant.|||1.26|0.47|0.537
72421620|NCT03720938|144354387|SUPERIORITY|||||||0.058102||||||The outcome of self-perception for strength competence was tested for any difference between groups by covariate analysis.|ANCOVA|Adjusted for self-perception for strength competence at baseline and confounding variable age.||Null hypothesis was the absence of difference between the two groups for the dependent variable self-perception of strength competence.||||0.058102
72421621|NCT03720938|144354387|SUPERIORITY|||||||0.051||||||Linear mixed-effects model fit by maximum likelihood since restricted maximum likelihood assumes a strong normality.|Linear mixed effects model|Adjusted for cluster effect in addition to baseline value and age.||Null hypothesis was the absence of difference between the two groups for the dependent variable self-perception of strength competence.||||0.051
72599340|NCT02756364|144729024|SUPERIORITY||Hazard Ratio (HR)|0.88||||0.849|TWO_SIDED|95.0|0.53|1.45|||Log Rank||HR obtained by stratified Cox proportional hazard model with treatment arm, original IRT stratification factors as covariates. A hazard ratio of \<1 was considered statistically significant.|||1.45|0.53|0.849
72599341|NCT02756364|144729025|SUPERIORITY||Hazard Ratio (HR)|0.71||||0.276|TWO_SIDED|95.0|0.36|1.4|||Log Rank||HR obtained by stratified Cox proportional hazard model with treatment arm, original IRT stratification factors as covariates. A hazard ratio of \<1 was considered statistically significant.|||1.40|0.36|0.276
72599342|NCT02756364|144729025|SUPERIORITY||Hazard Ratio (HR)|0.89||||0.47|TWO_SIDED|95.0|0.47|1.68|||Log Rank||HR obtained by stratified Cox proportional hazard model with treatment arm, original IRT stratification factors as covariates. A hazard ratio of \<1 was considered statistically significant.|||1.68|0.47|0.470
72599343|NCT02756364|144729026|SUPERIORITY||Hazard Ratio (HR)|0.76||||0.495|TWO_SIDED|95.0|0.46|1.25|||Log Rank||HR obtained by stratified Cox proportional hazard model with treatment arm, original IRT stratification factors as covariates. A hazard ratio of \<1 was considered statistically significant.|||1.25|0.46|0.495
72599344|NCT02756364|144729026|SUPERIORITY||Hazard Ratio (HR)|0.83||||0.646|TWO_SIDED|95.0|0.49|1.38|||Log Rank||HR obtained by stratified Cox proportional hazard model with treatment arm, original IRT stratification factors as covariates. A hazard ratio of \<1 was considered statistically significant.|||1.38|0.49|0.646
72599345|NCT02756364|144729027|SUPERIORITY||Odds Ratio (OR)|2.23|||||TWO_SIDED|95.0|0.68|7.29|||||The odds ratio and 95% CIs were obtained using a stratified Cochran-Mantel-Haenszel model with the original IRT stratification factors (visceral metastases, previous sensitivity to hormonal therapy, and previous exposure to CDK4/6 inhibitors).|||7.29|0.68|
72415843|NCT02131272|144342550|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was considered fulfilled if the upper bound of the two-sided 95% confidence interval for the difference between detemir and NPH was below or equal to 0.4%. The sample size was set to ensure 80% power for the full analysis set (FAS). However, efficacy conclusions cannot be drawn from the analysis due to low number of subjects included in the trial.|Least squares mean difference|0.17||||0.3075|TWO_SIDED|95.0|-0.74|1.09||p value is reported for 1 sided test|Mixed Models Analysis|||HbA1c measurements were analysed with a mixed model for repeated measurements with an unstructured covariance matrix. The model included treatment, visit, age group, prior antidiabetic therapy and interaction between prior antidiabetic therapy and age group as fixed factors and the HbA1c baseline value as covariate. Interactions between visit and all factors and covariates were also included in the model.||1.09|-0.74|0.3075
72599346|NCT02756364|144729027|SUPERIORITY||Odds Ratio (OR)|1.22|||||TWO_SIDED|95.0|0.34|4.39|||||The odds ratio and 95% CIs were obtained using a stratified Cochran-Mantel-Haenszel model with the original IRT stratification factors (visceral metastases, previous sensitivity to hormonal therapy, and previous exposure to CDK4/6 inhibitors).|||4.39|0.34|
72599347|NCT02756364|144729028|SUPERIORITY||Odds Ratio (OR)|2.56|||||TWO_SIDED|95.0|0.94|6.94|||||The odds ratio and 95% CIs were obtained using a stratified Cochran-Mantel-Haenszel model with the original IRT stratification factors (visceral metastases, previous sensitivity to hormonal therapy, and previous exposure to CDK4/6 inhibitors).|||6.94|0.94|
72599348|NCT02756364|144729028|SUPERIORITY||Odds Ratio (OR)|1.75|||||TWO_SIDED|95.0|0.69|4.44|||||The odds ratio and 95% CIs were obtained using a stratified Cochran-Mantel-Haenszel model with the original IRT stratification factors (visceral metastases, previous sensitivity to hormonal therapy, and previous exposure to CDK4/6 inhibitors).|||4.44|0.69|
72415844|NCT02701985|144342641|OTHER||Difference in Response Rates|4.27||||0.7955|TWO_SIDED|95.0|-20.55|29.08|||Chi-square with Schouten Correction|||The proportion of patients who have ≥ 3 point reduction from baseline in ESSDAI score after 12 weeks of treatment was compared between the two treatment arms using a Pearson Chi-square test (two sided p-values, alpha 0.05). The difference in proportions and corresponding 95% confidence interval (CI) are provided. Patients with missing data at Week 12 will be treated as non-responders in the analysis.||29.08|-20.55|0.7955
72599353|NCT02223364|144729045|SUPERIORITY|||||||0.144|||||||Wilcoxon (Mann-Whitney)|||||||0.144
72599354|NCT02223364|144729045|SUPERIORITY|||||||0.016|||||||Wilcoxon (Mann-Whitney)|||||||0.016
72599355|NCT02223364|144729045|SUPERIORITY|||||||0.196|||||||Wilcoxon (Mann-Whitney)|||||||0.196
72599356|NCT02223364|144729046|SUPERIORITY|||||||0.003|||||||Wilcoxon (Mann-Whitney)|||||||0.003
72599357|NCT02223364|144729046|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
72599358|NCT02223364|144729046|SUPERIORITY|||||||0.021|||||||Wilcoxon (Mann-Whitney)|||||||0.021
72599359|NCT02223364|144729047|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
72599360|NCT02223364|144729047|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
72599361|NCT02223364|144729047|SUPERIORITY|||||||0.257|||||||Wilcoxon (Mann-Whitney)|||||||0.257
72599362|NCT02223364|144729048|SUPERIORITY|||||||0.059|||||||Wilcoxon (Mann-Whitney)|||||||0.059
72599363|NCT02223364|144729048|SUPERIORITY|||||||0.005|||||||Wilcoxon (Mann-Whitney)|||||||0.005
72599364|NCT02223364|144729048|SUPERIORITY|||||||0.214|||||||Wilcoxon (Mann-Whitney)|||||||0.214
72599365|NCT02223364|144729049|SUPERIORITY|||||||0.189|||||||Wilcoxon (Mann-Whitney)|||||||0.189
72599366|NCT02223364|144729049|SUPERIORITY|||||||0.043|||||||Wilcoxon (Mann-Whitney)|||||||0.043
72599367|NCT02223364|144729049|SUPERIORITY|||||||0.357|||||||Wilcoxon (Mann-Whitney)|||||||0.357
72599368|NCT02223364|144729050|SUPERIORITY|||||||0.958|||||||Wilcoxon (Mann-Whitney)|||||||0.958
72599369|NCT02223364|144729050|SUPERIORITY|||||||0.203|||||||Wilcoxon (Mann-Whitney)|||||||0.203
72599370|NCT02223364|144729050|SUPERIORITY|||||||0.132|||||||Wilcoxon (Mann-Whitney)|||||||0.132
72599371|NCT02223364|144729051|SUPERIORITY|||||||0.493|||||||Wilcoxon (Mann-Whitney)|||||||0.493
72599372|NCT02223364|144729051|SUPERIORITY|||||||0.299|||||||Wilcoxon (Mann-Whitney)|||||||0.299
72599373|NCT02223364|144729051|SUPERIORITY|||||||0.797|||||||Wilcoxon (Mann-Whitney)|||||||0.797
72599374|NCT02223364|144729052|SUPERIORITY|||||||0.571|||||||Wilcoxon (Mann-Whitney)|||||||0.571
72599375|NCT02223364|144729052|SUPERIORITY|||||||0.991|||||||Wilcoxon (Mann-Whitney)|||||||0.991
72599376|NCT02223364|144729052|SUPERIORITY|||||||0.496|||||||Wilcoxon (Mann-Whitney)|||||||0.496
72599377|NCT02223364|144729053|SUPERIORITY|||||||0.807|||||||Wilcoxon (Mann-Whitney)|||||||0.807
72599378|NCT02223364|144729053|SUPERIORITY|||||||0.171|||||||Wilcoxon (Mann-Whitney)|||||||0.171
72599379|NCT02223364|144729053|SUPERIORITY|||||||0.104|||||||Wilcoxon (Mann-Whitney)|||||||0.104
72599380|NCT02223364|144729055|SUPERIORITY|||||||0.012|||||||Wilcoxon (Mann-Whitney)|||||||0.012
72599381|NCT02223364|144729055|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
72599382|NCT02223364|144729055|SUPERIORITY|||||||0.293|||||||Wilcoxon (Mann-Whitney)|||||||0.293
72599383|NCT02223364|144729056|SUPERIORITY|||||||0.202|||||||Wilcoxon (Mann-Whitney)|||||||0.202
72599384|NCT02223364|144729056|SUPERIORITY|||||||0.007|||||||Wilcoxon (Mann-Whitney)|||||||0.007
72599385|NCT02223364|144729056|SUPERIORITY|||||||0.148|||||||Wilcoxon (Mann-Whitney)|||||||0.148
72599386|NCT02223364|144729057|SUPERIORITY|||||||0.933|||||||Wilcoxon (Mann-Whitney)|||||||0.933
72599387|NCT02223364|144729057|SUPERIORITY|||||||0.169|||||||Wilcoxon (Mann-Whitney)|||||||0.169
72599388|NCT02223364|144729057|SUPERIORITY|||||||0.126|||||||Wilcoxon (Mann-Whitney)|||||||0.126
72599389|NCT02223364|144729058|SUPERIORITY|||||||0.768|||||||Kruskal-Wallis|||||||0.768
72599390|NCT02223364|144729059|SUPERIORITY|||||||0.623|||||||Regression, Cox|||Within group comparison of baseline and 3 months (approximately 12 weeks)||||0.623
72599391|NCT02223364|144729059|SUPERIORITY|||||||0.001|||||||Regression, Cox|||Within group comparison of baseline and 3 months (approximately 12 weeks)||||0.001
72599392|NCT02223364|144729059|SUPERIORITY|||||||0.048|||||||Regression, Cox|||Within group comparison of baseline and three months (approximately 12 weeks)||||0.048
72599393|NCT03597139|144729131|SUPERIORITY||Mean Difference (Final Values)|4.6||||0.1491|TWO_SIDED|95.0|-1.7|10.9|||ANCOVA|||||10.9|-1.7|0.1491
72599394|NCT03597139|144729132|SUPERIORITY||Mean Difference (Final Values)|6.1||||0.1187|TWO_SIDED|95.0|-1.6|13.9|||ANCOVA|||||13.9|-1.6|0.1187
72599395|NCT03597139|144729133|SUPERIORITY||Mean Difference (Final Values)|6.4||||0.2128|TWO_SIDED|95.0|-3.7|16.5|||ANCOVA|||||16.5|-3.7|0.2128
72599396|NCT03597139|144729134|SUPERIORITY||Mean Difference (Final Values)|-1.1||||0.8408|TWO_SIDED|95.0|-11.8|9.6|||ANCOVA|||||9.6|-11.8|0.8408
72599397|NCT03597139|144729135|SUPERIORITY||Mean Difference (Final Values)|2.8||||0.5356|TWO_SIDED|95.0|-6.1|11.6|||ANCOVA|||||11.6|-6.1|0.5356
72599398|NCT03597139|144729136|SUPERIORITY||Mean Difference (Final Values)|5.7||||0.1787|TWO_SIDED|95.0|-2.7|14.1|||ANCOVA|||||14.1|-2.7|0.1787
72599399|NCT03597139|144729137|SUPERIORITY||Mean Difference (Final Values)|-1.6||||0.7666|TWO_SIDED|95.0|-12.6|9.3|||ANCOVA|||||9.3|-12.6|0.7666
72599400|NCT03597139|144729138|SUPERIORITY||Mean Difference (Final Values)|-1.2||||0.8082|TWO_SIDED|95.0|-10.7|8.4|||ANCOVA|||||8.4|-10.7|0.8082
72599401|NCT03597139|144729139|SUPERIORITY||Mean Difference (Final Values)|11.6||||0.6362|TWO_SIDED|95.0|-37.0|60.3|||ANCOVA|||||60.3|-37|0.6362
72599402|NCT03597139|144729140|SUPERIORITY||Mean Difference (Final Values)|9.6||||0.0961|TWO_SIDED|95.0|-1.7|20.9||Frequency|ANCOVA|||Frequency||20.9|-1.7|0.0961
72599403|NCT03597139|144729140|SUPERIORITY||Mean Difference (Final Values)|7.7||||0.1722|TWO_SIDED|95.0|-3.4|18.7|||ANCOVA|||Severity||18.7|-3.4|0.1722
72599404|NCT03597139|144729141|SUPERIORITY||Mean Difference (Final Values)|5.2||||0.0051|TWO_SIDED|95.0|1.6|8.9||Left Eye|ANCOVA|||Left Eye||8.9|1.6|0.0051
72599405|NCT03597139|144729141|SUPERIORITY||Mean Difference (Final Values)|4.8||||0.0104|TWO_SIDED|95.0|1.1|8.4||Right Eye|ANCOVA|||Right Eye||8.4|1.1|0.0104
72599406|NCT03597139|144729142|SUPERIORITY||Mean Difference (Final Values)|-2.1||||0.0003|TWO_SIDED|95.0|-3.2|-1.0||Left Eye|ANCOVA||Add in RE LE info|Left Eye||-1.0|-3.2|0.0003
72599407|NCT03597139|144729142|SUPERIORITY||Mean Difference (Final Values)|-1.6||||0.0038|TWO_SIDED|95.0|-2.6|-0.5||Right Eye|ANCOVA|||Right Eye||-0.5|-2.6|0.0038
72599408|NCT01249833|144729165|SUPERIORITY_OR_OTHER||LS Means Difference|-30.4||||0.0492|TWO_SIDED|95.0|-60.7|-0.1|||ANCOVA||The LS means for Standard of Care Alone was subtracted from that of Oseltamivir.|||-0.1|-60.7|.0492
72599409|NCT01249833|144729166|SUPERIORITY_OR_OTHER||LS Means Difference|3.8||||0.0054|TWO_SIDED|95.0|1.14|6.42|||ANCOVA||The LS means for Standard of Care Alone was subtracted from that of Oseltamivir.|||6.42|1.14|0.0054
72599410|NCT01249833|144729167|SUPERIORITY_OR_OTHER||LS Means Difference|3.9||||0.9685|TWO_SIDED|95.0|-190.1|197.9|||ANCOVA||The LS means for Standard of Care Alone was subtracted from that of Oseltamivir.|||197.9|-190.1|.9685
72599411|NCT01249833|144729168|SUPERIORITY_OR_OTHER||LS Means Difference|1.9||||0.3195|TWO_SIDED|95.0|-1.9|5.7|||ANCOVA||The LS means for Standard of Care Alone was subtracted from that of Oseltamivir.|Alertness: the higher the value, the greater the alertness.||5.7|-1.9|.3195
72599412|NCT01249833|144729168|SUPERIORITY_OR_OTHER||LS Means Difference|-0.6||||0.7219|TWO_SIDED|95.0|-4.1|2.9|||ANCOVA||The LS means for Standard of Care AL one was subtracted from that of Oseltamivir.|Calmness: the higher the value, the greater the calmness.||2.9|-4.1|.7219
72599413|NCT01249833|144729168|SUPERIORITY_OR_OTHER||LS Means Difference|3.3||||0.1162|TWO_SIDED|95.0|-0.8|7.4|||ANCOVA||The LS means of Standard of Care Alone was subtracted from that of Oseltamivir.|Contentedness: the higher the value, the greater the contentedness.||7.4|-.8|.1162
72599414|NCT03796676|144729169|SUPERIORITY||Estimate of difference|16.7||||0.0147|TWO_SIDED|95.0|3.5|29.9|||Cochran-Mantel-Haenszel||Estimate of the difference in percentages of response at Week 12 was calculated by PF-04965842 100 mg minus placebo|||29.9|3.5|0.0147
72599415|NCT03796676|144729169|SUPERIORITY||Estimate of difference|20.6||||0.003|TWO_SIDED|95.0|7.3|33.9|||Cochran-Mantel-Haenszel||Estimate of the difference in percentages of response at Week 12 was calculated by PF-04965842 200 mg minus placebo|||33.9|7.3|0.0030
72599416|NCT03796676|144729170|SUPERIORITY||Estimate of difference|26.5||||0.0002|TWO_SIDED|95.0|13.1|39.8|||Cochran-Mantel-Haenszel||Estimate of the difference in percentages of response at Week 12 was calculated by PF-04965842 100 mg minus placebo|||39.8|13.1|0.0002
72599417|NCT03796676|144729170|SUPERIORITY||Estimate of difference|29.4|||<|0.0001|TWO_SIDED|95.0|16.3|42.5|||Cochran-Mantel-Haenszel||Estimate of the difference in percentages of response at Week 12 was calculated by PF-04965842 200 mg minus placebo|||42.5|16.3|<0.0001
72599418|NCT03796676|144729171|SUPERIORITY||Estimate of difference|14.7||||0.0119||95.0|3.5|25.9|||Cochran-Mantel-Haenszel||Estimate of the difference in percentages of response at Week 2 was calculated by PF-04965842 100 mg minus placebo|||25.9|3.5|0.0119
72599419|NCT03796676|144729171|SUPERIORITY||Estimate of difference|26.1|||<|0.0001|TWO_SIDED|95.0|13.9|38.3|||Cochran-Mantel-Haenszel||Estimate of the difference in percentages of response at Week 2 was calculated by PF-04965842 200 mg minus placebo|||38.3|13.9|<0.0001
72599420|NCT03796676|144729171|SUPERIORITY||Estimate of difference|10.9||||0.0971|TWO_SIDED|95.0|-1.8|23.6|||Cochran-Mantel-Haenszel||Estimate of the difference in percentages of response at Week 4 was calculated by PF-04965842 100 mg minus placebo|||23.6|-1.8|0.0971
72599421|NCT03796676|144729171|SUPERIORITY||Estimate of difference|29.4|||<|0.0001|TWO_SIDED|95.0|16.0|42.9|||Cochran-Mantel-Haenszel||Estimate of the difference in percentages of response at Week 4 was calculated by PF-04965842 200 mg minus placebo|||42.9|16.0|<0.0001
72599422|NCT03796676|144729171|SUPERIORITY||Estimate of difference|22.8||||0.0035|TWO_SIDED|95.0|8.0|37.7|||Cochran-Mantel-Haenszel||Estimate of the difference in percentages of response at Week 12 was calculated by PF-04965842 100 mg minus placebo|||37.7|8.0|0.0035
72599423|NCT03796676|144729171|SUPERIORITY||Estimate of difference|25.6||||0.0013|TWO_SIDED|95.0|10.6|40.6|||Cochran-Mantel-Haenszel||Estimate of the difference in percentages of response at Week 12 was calculated by PF-04965842 200 mg minus placebo|||40.6|10.6|0.0013
72599424|NCT03796676|144729172|SUPERIORITY||Mean Difference (Net)|-0.5||||0.0664|TWO_SIDED|95.0|-1.1|0.0|||Mixed Models Analysis||The least squares mean difference at Week 12 was calculated by PF-04965842 100 mg minus placebo|||0.0|-1.1|0.0664
72599425|NCT03796676|144729172|SUPERIORITY||Mean Difference (Net)|-0.7||||0.0142|TWO_SIDED|95.0|-1.3|-0.1|||Mixed Models Analysis||The least squares mean difference at Week 12 was calculated by PF-04965842 200 mg minus placebo|||-0.1|-1.3|0.0142
72599426|NCT02724410|144729214|OTHER|Chi Square test of independence||||||0.7188|||||||Chi-squared|||||||0.7188
72599427|NCT02724410|144729215|OTHER|Chi Square test of independence||||||0.5933|||||||Chi-squared|||||||.5933
72599428|NCT02724410|144729216|OTHER|Chi Square test of independence|||||>|0.99|||||||Chi-squared|||||||>.99
72599429|NCT02724410|144729217|OTHER|T-test for difference between groups|||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||<.0001
72599430|NCT00762034|144729263|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.0||||0.94896|TWO_SIDED|95.0|0.86|1.16|||Log Rank|||||1.16|0.86|0.94896
72599431|NCT00762034|144729264|SUPERIORITY_OR_OTHER|||||||0.72997||95.0|||||Fisher Exact|||||||0.72997
72599432|NCT00762034|144729265|SUPERIORITY_OR_OTHER|||||||0.20892|||||||Fisher Exact|||||||0.20892
72599433|NCT00762034|144729266|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.83||||0.01206|TWO_SIDED|95.0|0.71|0.96|||Log Rank|||||0.96|0.71|0.01206
72599434|NCT00762034|144729267|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.79||||0.006|TWO_SIDED|95.0|0.67|0.94|||Log Rank|||||0.94|0.67|0.006
72599435|NCT00762034|144729272|SUPERIORITY_OR_OTHER|||||||0.667||95.0||||Mixed Model Analysis has treatment, baseline, time point, and treatment by timepoint interaction as fixed effects.|Mixed Models Analysis|||||||0.667
72599436|NCT00762034|144729273|SUPERIORITY_OR_OTHER|||||||0.815||95.0||||p-value for FACT-L Total; Mixed Model Analysis has treatment, baseline, time point, and treatment by timepoint interaction as fixed effects.|Mixed Models Analysis|||||||0.815
72599437|NCT00762034|144729273|SUPERIORITY_OR_OTHER|||||||0.978||95.0||||p-value for FACT-L TOI; Mixed Model Analysis has treatment, baseline, time point, and treatment by timepoint interaction as fixed effects.|Mixed Models Analysis|||||||0.978
72599438|NCT00762034|144729274|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value for FACT/GOG-Ntx Total; Mixed Model Analysis has treatment, baseline, time point, and treatment by timepoint interaction as fixed effects.|Mixed Models Analysis|||||||<0.001
72599439|NCT00762034|144729274|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value for FACT/GOG-Ntx TOI; Mixed Model Analysis has treatment, baseline, time point, and treatment by timepoint interaction as fixed effects.|Mixed Models Analysis|||||||<0.001
72599440|NCT00762034|144729288|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.48|||<|0.001|TWO_SIDED|95.0|0.338|0.681||p-value was not adjusted for multiple comparisons.|Regression, Cox|||||0.681|0.338|<0.001
72599441|NCT00762034|144729289|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.927||||0.673|TWO_SIDED|95.0|0.654|1.316||p-value is for TS Cytoplasm Positive (H score \> 0) comparing treatment arms and was not adjusted for multiple comparisons.|Regression, Cox|||||1.316|0.654|0.673
72599442|NCT00762034|144729289|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.521||||0.287|TWO_SIDED|95.0|0.157|1.729||p-value is for TS Cytoplasm Negative (H score = 0) comparing treatment arms and was not adjusted for multiple comparisons.|Regression, Cox|||||1.729|0.157|0.287
72599443|NCT00762034|144729289|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.759||||0.2|TWO_SIDED|95.0|0.498|1.157||p-value is for TS Nucleus Positive (H score \> 0) comparing treatment arms and was not adjusted for multiple comparisons.|Regression, Cox|||||1.157|0.498|0.2
72599444|NCT00762034|144729289|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.969||||0.915|TWO_SIDED|95.0|0.54|1.738||p-value is for TS Nucleus Negative (H score = 0) comparing treatment arms and was not adjusted for multiple comparisons.|Regression, Cox|||||1.738|0.540|0.915
72415845|NCT02701985|144342642|OTHER||Difference in Response Rates|1.14||||0.9877|TWO_SIDED|95.0|-23.92|26.19|||Chi-square with Schouten Correction|||The proportion of patients who have ≥ 1 point reduction from baseline in ESSPRI score after 12 weeks of treatment was compared between the two treatment arms using a Pearson Chi-square test (two sided p-values, alpha 0.05). The difference in proportions and corresponding 95% CI are provided. Patients with missing data at Week 12 will be treated as non-responders in the analysis.||26.19|-23.92|0.9877
72599445|NCT00762034|144729290|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.97||||0.891|TWO_SIDED|95.0|0.622|1.511||p-value for FR-α Cytoplasm Positive (H score \> 0) comparing treatment arms and was not adjusted for multiple comparisons.|Regression, Cox|||||1.511|0.622|0.891
72599446|NCT00762034|144729290|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.592||||0.06|TWO_SIDED|95.0|0.342|1.023||p-value for FR-α Cytoplasm Negative (H score = 0) comparing treatment arms and was not adjusted for multiple comparisons.|Regression, Cox|||||1.023|0.342|0.060
72599447|NCT00762034|144729290|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.96||||0.905|TWO_SIDED|95.0|0.49|1.88||p-value for FR-α Membrane Positive (H score \> 0) comparing treatment arms and was not adjusted for multiple comparisons.|Regression, Cox|||||1.880|0.490|0.905
72599448|NCT00762034|144729290|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.859||||0.455|TWO_SIDED|95.0|0.575|1.281||p-value for FR-α Membrane Negative (H score = 0) comparing treatment arms and was not adjusted for multiple comparisons.|Regression, Cox|||||1.281|0.575|0.455
72599449|NCT02442206|144729291|SUPERIORITY||Mean Difference (Net)|10.27|||<|0.0001|TWO_SIDED|95.0|6.209|14.331|||ANOVA|||||14.331|6.209|<0.0001
72599450|NCT02442206|144729292|SUPERIORITY||Mean Difference (Net)|0.42|||<|0.0001|TWO_SIDED|95.0|0.36|0.49|||ANOVA|||||0.49|0.36|<0.0001
72599451|NCT02442206|144729293|SUPERIORITY||Mean Difference (Net)|0.67|||<|0.0001|TWO_SIDED|95.0|0.55|0.8|||ANOVA|||||0.80|0.55|<0.0001
72599452|NCT02442206|144729294|SUPERIORITY||Mean Difference (Net)|0.446|||<|0.0001|TWO_SIDED|95.0|0.352|0.541|||ANOVA|||||0.541|0.352|<0.0001
72599453|NCT02442206|144729295|SUPERIORITY||Mean Difference (Net)|-0.177||||0.0017|TWO_SIDED|95.0|-0.285|-0.07|||ANOVA|||||-0.070|-0.285|0.0017
72599454|NCT02442206|144729296|SUPERIORITY||Mean Difference (Net)|-0.751|||<|0.0001|TWO_SIDED|95.0|-0.925|-0.577|||ANOVA|||||-0.577|-0.925|<0.0001
72599455|NCT02442206|144729297|SUPERIORITY||Mean Difference (Net)|-1.639|||<|0.0001|TWO_SIDED|95.0|-1.945|-1.332|||ANOVA|||||-1.332|-1.945|<0.0001
72599456|NCT02442206|144729298|SUPERIORITY||Mean Difference (Net)|-0.625|||<|0.0001|TWO_SIDED|95.0|-0.761|-0.489|||ANOVA|||||-0.489|-0.761|<0.0001
72599457|NCT02442206|144729299|SUPERIORITY||Mean Difference (Net)|1.209||||0.142|TWO_SIDED|95.0|-0.419|2.836|||ANOVA|||LV EF||2.836|-0.419|0.1420
72599458|NCT02442206|144729299|SUPERIORITY||Mean Difference (Net)|1.131||||0.1732|TWO_SIDED|95.0|-0.512|2.774|||ANOVA|||RV EF||2.774|-0.512|0.1732
72599459|NCT02442206|144729300|SUPERIORITY||Mean Difference (Net)|2.241||||0.0437|TWO_SIDED|95.0|0.066|4.417|||ANOVA|||LV ESV||4.417|0.066|0.0437
72599460|NCT02442206|144729300|SUPERIORITY||Mean Difference (Net)|2.095||||0.1236|TWO_SIDED|95.0|-0.591|4.782|||ANOVA|||RV ESV||4.782|-0.591|0.1236
72599461|NCT02442206|144729301|SUPERIORITY||Mean Difference (Net)|9.357||||0.0002|TWO_SIDED|95.0|4.649|14.065|||ANOVA|||||14.065|4.649|0.0002
72599462|NCT02442206|144729302|SUPERIORITY||Mean Difference (Net)|0.337||||0.0032|TWO_SIDED|95.0|0.118|0.555|||ANOVA|||LVCO||0.555|0.118|0.0032
72599463|NCT02442206|144729302|SUPERIORITY||Mean Difference (Net)|0.281||||0.0182|TWO_SIDED|95.0|0.05|0.512|||ANOVA|||RVCO||0.512|0.050|0.0182
72599464|NCT00497146|144729303|SUPERIORITY_OR_OTHER|||||||0.145||95.0|||||Mixed Models Analysis|Mixed model includes treatment, visit, gender, baseline RAAS inhibitor use, country, baseline value, and treatment by visit interaction.||||||0.145
72599465|NCT01088711|144729330|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|90.76|||||TWO_SIDED|90.0|82.7|99.37|||Difference in geometric means (GMs)|||||99.37|82.70|
72599466|NCT01088711|144729332|SUPERIORITY_OR_OTHER||Ratio of geometric least-squares means|1.92|||||TWO_SIDED|90.0|1.55|2.38|||||GMR is ratio of active GLP-1 levels in omarigliptin:placebo groups.|||2.38|1.55|
72599467|NCT01088711|144729333|SUPERIORITY_OR_OTHER||Ratio of geometric least-squares means|0.91|||||TWO_SIDED|90.0|0.72|1.17|||||GMR is ratio of total GLP-1 levels in omarigliptin:placebo groups.|||1.17|0.72|
72599468|NCT01240902|144729335|SUPERIORITY_OR_OTHER_LEGACY||Kaplan-Meier|26.0|STANDARD_ERROR_OF_MEAN|2.0|<|0.0001|TWO_SIDED|95.0|22.3|30.1|||z-test, 1 sided||Kaplan-Meier Event Rate Greenwood Standard Error|TAVR with the Medtronic CoreValve System meets the Performance Goal in the 12 month rate of all-cause mortality or major stroke H0: = πMCS TAVI ≥ 43.0% HA: = πMCS TAVI \< 43.0% In the above expressions πMCS TAVI denotes the rate of all-cause mortality or major stroke during a fixed follow-up of 1 year.||30.1|22.3|<0.0001
72599469|NCT01240902|144729335|SUPERIORITY_OR_OTHER_LEGACY||Kaplan-Meier|39.3|STANDARD_ERROR_OF_MEAN|4.0|||TWO_SIDED||||||||Kaplan-Meier Event Rate Greenwood Standard Error|No performance goal created, only descriptive statistics are provided.||||
72599470|NCT01240902|144729335|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The 12 month all-cause mortality estimated rate was 20% for each group with a noninferiority margin of 7.5 percentage points. Assuming a 1:1 ratio in the treatment assignments, we estimated that a total of 355 patients were required in each group for the study to have power of 80% at a one-sided alpha level of 0.05. Accounting for a 10% loss to follow-up, we calculated that we would need to enroll 790 patients.|||||<|0.0001|TWO_SIDED||||||z-test, 1 sided|||||||<0.0001
72599471|NCT01240902|144729336|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1033|TWO_SIDED|||||Hierarchical test item #5, MACCE at 30 days or hospital discharge; whichever was longer. K-M rates TAVR 8.21%, SAVR 10.93%, Difference -2.73%, Standard Error 2.16%, and Upper 95% CI 1.5%.|Kaplan-Meier Point Estimate|Using Greenwood formula||"Powered Secondary Hypothesis: TAVR with the Medtronic CoreValve System was superior to SAVR in binary rate of MACCE at 30 days or hospital discharge, whichever was longer:~H0: πMCS TAVR = πSAVR HA: πMCS TAVR \< πSAVR In the above expression πMCS TAVR and πSAVR denoted rates of MACCE at 30 days or hospital discharge, whichever was longer.~Assumptions:~1:1 treatment allocation ratio One-sided alpha=0.025 SAVR = 20.0% MCS TAVI = 12.1% Power = \>80%"||||0.1033
72599472|NCT01240902|144729340|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-1.6|STANDARD_DEVIATION|0.9|<|0.0001|TWO_SIDED|||||Hierarchical test item #3, change from baseline to 1 year.|t-test, 2 sided|||Change in NYHA classification from baseline to 1 year from secondary objective #5. The paired t-test will be used to test the null hypothesis that the mean paired difference is zero versus the two-sided alternative that the mean is not zero.||||<0.0001
72599473|NCT01240902|144729340|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority margin= 0.375. For subjects with NYHA categories at both baseline and 1 year visit, the NYHA classification improvements were calculated as NYHAbaseline - NYHA1year.|||||<|0.0001|TWO_SIDED|||||Hierarchical test item #3, change from baseline to 1 year.|t-test, 1 sided|||"Change in NYHA classification from baseline to 1 year: TAVR vs. SAVR from secondary objective #5. The one-sided two-sample t-test was used to test non-inferiority at a level 0.05 the hypotheses:~H0: µ MCS TAVR ≤ µ SAVR -0.375 HA: µ MCS TAVR \> µ SAVR -0.375 In the above expression µ MCS TAVR and µ SAVR denoted the mean number of classification improvements in NYHA from baseline to 1 year."||||<0.0001
72599474|NCT01240902|144729343|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED|||||Hierarchical test item #4|t-test, 2 sided|||Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) score from baseline to 1 year from secondary objective #8. The paired t-test will be used to test the null hypothesis that the mean paired difference is zero versus the two-sided alternative that the mean is not zero.||||<0.0001
72599475|NCT01240902|144729343|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority margin 5||||||0.0063|TWO_SIDED|||||Hierarchical test item #4|t-test, 1 sided|||"Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) score from baseline to 1 year: TAVR vs. SAVR from secondary objective #8. The one-sided two-sample t-test was used to test non-inferiority at a level 0.05 the hypotheses:~H0: µ MCS TAVR ≤ µ SAVR -5 HA: µ MCS TAVR \> µ SAVR -5 In the above expression µ MCS TAVR and µ SAVR denoted the mean improvements in the KCCQ score from baseline to 1 year."||||0.0063
72599476|NCT01240902|144729343|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED|||||Hierarchical test item #6. Item #5 failed, therefore, item #6 also fails. Nominal p- value provided.|t-test, 2 sided|||"Change in SF-12 Physical Summary Scale from baseline to 30 days: TAVR vs. SAVR from secondary objective #8. The two-sided two-sample t-test was used to test at a level 0.05 the hypotheses:~H0: µ MCS TAVR = µ SAVR HA: µ MCS TAVR ≠ µ SAVR In the above expression µ MCS TAVR and µ SAVR denoted the mean improvements in the SF-12 Physical Summary Scale from baseline to 30 days."||||<0.0001
72599477|NCT01240902|144729344|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED|||||Hierarchical test item #2|t-test, 2 sided|||"EOA:~Change in effective orifice area from Baseline to 1 year from secondary objective #9. The paired t-test will be used to test the null hypothesis that the mean paired difference is zero versus the two-sided alternative that the mean is not zero."||||<0.0001
72599478|NCT01240902|144729344|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority margin 0.375|||||<|0.0001|TWO_SIDED|||||Hierarchical test item #2|t-test, 1 sided|||"EOA:~Change in effective orifice area from Baseline to 1 year: TAVR vs.SAVR from secondary objective #9. The one-sided two-sample t-test was used to test non-inferiority at a level 0.05 the hypotheses:~H0: µ MCS TAVR ≤ µ SAVR -0.375 HA: µ MCS TAVR \> µ SAVR -0.375 In the above expression µ MCS TAVR and µ SAVR denoted the mean improvements in effective orifice area from Baseline to 1 year measured in cm2."||||<0.0001
72599479|NCT01240902|144729345|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED|||||Hierarchical test item #1|t-test, 2 sided|||"Transvalvular Mean Gradient:~Change in transvalvular mean gradient from baseline to 1 year from secondary objective #9. The paired t-test will be used to test the null hypothesis that the mean paired difference is zero versus the two-sided alternative that the mean is not zero."||||<0.0001
72599480|NCT01240902|144729345|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority margin 15|||||<|0.0001|TWO_SIDED|||||Hierarchical test item #1|t-test, 1 sided|||"Transvalvular Mean Gradient:~Change in transvalvular mean gradient from baseline to 1 year: TAVR vs.SAVR from secondary objective #9. The one-sided two-sample t-test was used to test non-inferiority at a level of 0.05 the hypotheses: H0: μ MCS TAVR ≤ μ SAVR -15 HA: μ MCS TAVR \> μ SAVR -15 In the above expression μ MCS TAVR and μ SAVR denoted the mean improvements in mean gradient from Baseline to 1 year measured in mmHg."||||<0.0001
72599481|NCT01441245|144729355|NON_INFERIORITY_OR_EQUIVALENCE|The sample size used was preliminarily calculated from each co-primary endpoint. We included the following assumptions: (1) a 30 % or more effect size in the difference between mean paired changes in continuous co-primary endpoints (eGFR, creatinine, BNP and diuresis); standard variation of each group data not exceeding 20 %; (2) alpha = 0.05 two-tailed and (3) power (1-beta) = 80 %.||||||0.04|TWO_SIDED||||||t-test, 2 sided|||Continuous variables are expressed as mean ± standard deviation (SD) and compared with t test for independent groups. p values \<0.05 were considered significant.||||0.04
72599482|NCT01441245|144729356|NON_INFERIORITY_OR_EQUIVALENCE|The sample size used was preliminarily calculated from each co-primary endpoint. We included the following assumptions: (1) a 30 % or more effect size in the difference between mean paired changes in continuous co-primary endpoints (eGFR, creatinine, BNP and diuresis); standard variation of each group data not exceeding 20 %; (2) alpha = 0.05 two-tailed and (3) power (1-beta) = 80 %.|||||<|0.01|TWO_SIDED||||||Chi-squared|||Qualitative variables are expressed as percentage and compared with chi-square test. p values \<0.05 were considered significant.||||<0.01
72415846|NCT02701985|144342643|SUPERIORITY||Difference in Adjusted Means|-0.13||||0.8905|TWO_SIDED|95.0|-2.04|1.78|||Mixed Model for Repeated Measures|||A Mixed Model for Repeated Measures (MMRM) approach incorporating all observed data up to 12 weeks of treatment was used. The MMRM included the absolute change from baseline as the dependent variable.||1.78|-2.04|0.8905
72415847|NCT02701985|144342644|SUPERIORITY||Difference in Adjusted Means|-0.22||||0.6077|TWO_SIDED|95.0|-1.08|0.64|||Mixed Model of Repeated Measures|||A Mixed Model for Repeated Measures (MMRM) approach incorporating all observed data up to 12 weeks of treatment was used. The MMRM included the absolute change from baseline as the dependent variable.||0.64|-1.08|0.6077
72599483|NCT01441245|144729357|NON_INFERIORITY_OR_EQUIVALENCE|The sample size used was preliminarily calculated from each co-primary endpoint. We included the following assumptions: (1) a 30 % or more effect size in the difference between mean paired changes in continuous co-primary endpoints (eGFR, creatinine, BNP and diuresis); standard variation of each group data not exceeding 20 %; (2) alpha = 0.05 two-tailed and (3) power (1-beta) = 80 %.||||||0.01|TWO_SIDED||||||t-test, 2 sided|||||||0.01
72415848|NCT02701985|144342645|SUPERIORITY||Difference in Adjusted Means|-2.06||||0.2846||95.0|-5.87|1.75|||Mixed Model of Repeated Measures|||A Mixed Model for Repeated Measures (MMRM) approach incorporating all observed data up to 12 weeks of treatment was used. The MMRM included the absolute change from baseline as the dependent variable||1.75|-5.87|0.2846
72599484|NCT01441245|144729358|NON_INFERIORITY_OR_EQUIVALENCE|The sample size used was preliminarily calculated from each co-primary endpoint. We included the following assumptions: (1) a 30 % or more effect size in the difference between mean paired changes in continuous co-primary endpoints (eGFR, creatinine, BNP and diuresis); standard variation of each group data not exceeding 20 %; (2) alpha = 0.05 two-tailed and (3) power (1-beta) = 80 %.||||||0.02|TWO_SIDED||||||t-test, 2 sided|||||||0.02
72599485|NCT01441245|144729359|NON_INFERIORITY_OR_EQUIVALENCE|The sample size used was preliminarily calculated from each co-primary endpoint. We included the following assumptions: (1) a 30 % or more effect size in the difference between mean paired changes in continuous co-primary endpoints (eGFR, creatinine, BNP and diuresis); standard variation of each group data not exceeding 20 %; (2) alpha = 0.05 two-tailed and (3) power (1-beta) = 80 %.||||||0.04|TWO_SIDED||||||t-test, 2 sided|||||||0.04
72599486|NCT01441245|144729359|NON_INFERIORITY_OR_EQUIVALENCE|The sample size used was preliminarily calculated from each co-primary endpoint. We included the following assumptions: (1) a 30 % or more effect size in the difference between mean paired changes in continuous co-primary endpoints (eGFR, creatinine, BNP and diuresis); standard variation of each group data not exceeding 20 %; (2) alpha = 0.05 two-tailed and (3) power (1-beta) = 80 %.|Risk Ratio (RR)|2.06||||0.01|TWO_SIDED|95.0|1.65|2.57|||Regression, Linear||BNP levels at discharge \>500 pg/ml (RR: 2.06 \[1.65-2.57\];).|||2.57|1.65|0.01
72599487|NCT01441245|144729360|NON_INFERIORITY_OR_EQUIVALENCE|The sample size used was preliminarily calculated from each co-primary endpoint. We included the following assumptions: (1) a 30 % or more effect size in the difference between mean paired changes in continuous co-primary endpoints (eGFR, creatinine, BNP and diuresis); standard variation of each group data not exceeding 20 %; (2) alpha = 0.05 two-tailed and (3) power (1-beta) = 80 %.||||||0.03|TWO_SIDED||||||t-test, 2 sided|||Continuous variables are expressed as mean ± standard deviation (SD) and compared with t test for independent groups. p values \<0.05 were considered significant.||||0.03
72599488|NCT01441245|144729361|NON_INFERIORITY_OR_EQUIVALENCE|The sample size used was preliminarily calculated from each co-primary endpoint. We included the following assumptions: (1) a 30 % or more effect size in the difference between mean paired changes in continuous co-primary endpoints (eGFR, creatinine, BNP and diuresis); standard variation of each group data not exceeding 20 %; (2) alpha = 0.05 two-tailed and (3) power (1-beta) = 80 %.||||||0.01|TWO_SIDED||||||t-test, 2 sided|||Continuous variables are expressed as mean ± standard deviation (SD) and compared with t test for independent groups. p values \<0.05 were considered significant.||||0.01
72599489|NCT01441245|144729362|NON_INFERIORITY_OR_EQUIVALENCE|The sample size used was preliminarily calculated from each co-primary endpoint. We included the following assumptions: (1) a 30 % or more effect size in the difference between mean paired changes in continuous co-primary endpoints (eGFR, creatinine, BNP and diuresis); standard variation of each group data not exceeding 20 %; (2) alpha = 0.05 two-tailed and (3) power (1-beta) = 80 %.||||||0.05|TWO_SIDED||||||t-test, 2 sided|||Continuous variables are expressed as mean ± standard deviation (SD) and compared with t test for independent groups. p values \<0.05 were considered significant||||0.05
72599490|NCT01441245|144729363|NON_INFERIORITY_OR_EQUIVALENCE|The sample size used was preliminarily calculated from each co-primary endpoint. We included the following assumptions: (1) a 30 % or more effect size in the difference between mean paired changes in continuous co-primary endpoints (eGFR, creatinine, BNP and diuresis); standard variation of each group data not exceeding 20 %; (2) alpha = 0.05 two-tailed and (3) power (1-beta) = 80 %.|||||<|0.01|TWO_SIDED||||||Chi-squared|||Qualitative variables are expressed as percentage of partecipants and compared with chi-square test. p-value equal or lower than 0.05 are considered statistically significant.||||<0.01
72599491|NCT01649362|144729378|SUPERIORITY_OR_OTHER|||||||0.63||95.0|||||t-test, 2 sided|||||||0.63
72599492|NCT01649362|144729379|SUPERIORITY_OR_OTHER|||||||0.36||95.0|||||t-test, 2 sided|||||||0.36
72599493|NCT01649362|144729380|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||Chi-squared|||||||0.02
72599494|NCT00929994|144729391|OTHER||||||=|0.06||||||A Bonferroni correction for multiple testing was used for post hoc contrasts. Assumption of sphericity was met for all analyses determined by the Mauchley test of sphericity (all \>.05).|ANOVA|||With 1 group and 3 test times, a repeated measures analysis of variance of 6MWD, was utilized between the 3 test times 0, 3, and 6 months). A Bonferroni correction for multiple testing was used for post hoc contrasts.||||=0.06
72599495|NCT00929994|144729391|SUPERIORITY|||||||0.06|||||||t-test, 2 sided|||||||0.06
72599496|NCT00929994|144729392|SUPERIORITY|||||||0.01|||||||t-test, 2 sided|||||||0.01
72599497|NCT00929994|144729393|SUPERIORITY|||||||0.04||||||A Bonferroni correction for multiple testing was used for post-hoc contrasts.|ANOVA|||With 1 group and 3 test times, a repeated measures analysis of variance with pairwise comparisons of CES-D was utilized between the 3 test times baseline, 3 and 6 months.||||0.04
72599498|NCT00929994|144729394|SUPERIORITY||||||>|0.05||||||A Bonferroni correction for multiple testing was used for post-hoc contrasts|ANOVA|||With 1 group and 3 test times, a repeated measures analysis of variance with pairwise comparisons of MoCA was utilized between the 3 test times (-3, 0 and 6 months). A Bonferroni correction for multiple testing was used for post-hoc contrasts.||||>0.05
72599499|NCT01964989|144729401|SUPERIORITY|Relative vaccine efficacy (rVE; ≥6 to \<72 months) rVE = (1-HR) is the relative vaccine efficacy of aQIV and HR is defined as hazard ratio between aQIV and non adjuvanted comparator.|Cox Proportional Hazard|-0.67|||||TWO_SIDED|95.0|-19.81|15.41||||||||15.41|-19.81|
72415849|NCT02701985|144342646|SUPERIORITY||Difference in Adjusted Means|-0.33||||0.8134||95.0|-2.43|3.08|||Mixed Model of Repeated Measures|||A Mixed Model for Repeated Measures (MMRM) approach incorporating all observed data up to 12 weeks of treatment was used. The MMRM included the absolute change from baseline as the dependent variable||3.08|-2.43|0.8134
72599500|NCT01964989|144729408|SUPERIORITY|Superiority criterion: The lower bound of the two-sided 95% confidence interval (CI) on the adjusted ratio of GMTs for HI antibody titer exceeds 1.|GMT ratio|1.91|||||TWO_SIDED|95.0|1.8|2.0||||||GMT ratio (aQIV/Comparator \[TIV/QIV\]) for A/H1N1, D22/50 (Pooled Naïve \& Non-naïve). An adjusted analysis GMT model (log-transformed postvaccination HI titer = log-transformed prevaccination HI titer+treatment group+ age group, health status+ season + country) was used for analysis.||2.0|1.8|
72599501|NCT01964989|144729408|OTHER||GMT ratio|1.86|||||TWO_SIDED|95.0|1.7|2.0||||||GMT ratio (aQIV/Comparator \[TIV/QIV\]) for A/H1N1, D181/209 (Pooled Naïve \& Non-naïve). An adjusted analysis GMT model (log-transformed postvaccination HI titer = log-transformed prevaccination HI titer+treatment group+ age group, health status+ season + country) was used for analysis.||2.0|1.7|
72599502|NCT01964989|144729408|SUPERIORITY|Superiority criterion: The lower bound of the two-sided 95% CI on the adjusted ratio of GMTs for HI antibody titer exceeds 1.|GMT ratio|1.71|||||TWO_SIDED|95.0|1.6|1.8||||||GMT ratio (aQIV/Comparator \[TIV/QIV\]) for A/H3N2, D22/50 (Pooled Naïve \& Non-naïve). An adjusted analysis GMT model (log-transformed postvaccination HI titer = log-transformed prevaccination HI titer+treatment group+ age group, health status+ season + country) was used for analysis.||1.8|1.6|
72599503|NCT01964989|144729408|OTHER||GMT ratio|1.57|||||TWO_SIDED|95.0|1.4|1.7||||||GMT ratio (aQIV/Comparator \[TIV/QIV\]) for A/H3N2, D181/209 (Pooled Naïve \& Non-naïve). An adjusted analysis GMT model (log-transformed postvaccination HI titer = log-transformed prevaccination HI titer+treatment group+ age group, health status+ season + country) was used for analysis.||1.7|1.4|
72599504|NCT01964989|144729408|SUPERIORITY|Superiority criterion: The lower bound of the two-sided 95% CI on the adjusted ratio of GMTs for HI antibody titer exceeds 1.|GMT ratio|2.19|||||TWO_SIDED|95.0|2.0|2.4||||||GMT ratio (aQIV/Comparator \[TIV/QIV\]) for B/YAM, D22/50 (Pooled Naïve \& Non-naïve). An adjusted analysis GMT model (log-transformed postvaccination HI titer = log-transformed prevaccination HI titer+treatment group+ age group, health status+ season + country) was used for analysis.||2.4|2.0|
72599505|NCT01964989|144729408|OTHER||GMT ratio|1.86|||||TWO_SIDED|95.0|1.7|2.0||||||GMT ratio (aQIV/Comparator \[TIV/QIV\]) for B/YAM, D181/209 (Pooled Naïve \& Non-naïve). An adjusted analysis GMT model (log-transformed postvaccination HI titer = log-transformed prevaccination HI titer+treatment group+ age group, health status+ season + country) was used for analysis.||2.0|1.7|
72599506|NCT01964989|144729408|SUPERIORITY|Superiority criterion: The lower bound of the two-sided 95% CI on the adjusted ratio of GMTs for HI antibody titer exceeds 1.|GMT ratio|2.27|||||TWO_SIDED|95.0|2.0|2.6||||||GMT ratio (aQIV/Comparator \[TIV/QIV\]) for B/VIC, D22/50 (Pooled Naïve \& Non-naïve). An adjusted analysis GMT model (log-transformed postvaccination HI titer = log-transformed prevaccination HI titer+treatment group+ age group, health status+ season + country) was used for analysis.||2.6|2.0|
72599507|NCT01964989|144729408|OTHER||GMT ratio|1.8|||||TWO_SIDED|95.0|1.6|2.1||||||GMT ratio (aQIV/Comparator \[TIV/QIV\]) for B/VIC, D181/209 (Pooled Naïve \& Non-naïve). An adjusted analysis GMT model (log-transformed postvaccination HI titer = log-transformed prevaccination HI titer+treatment group+ age group, health status+ season + country) was used for analysis.||2.1|1.6|
72599508|NCT01964989|144729410|OTHER||GMT ratio|0.92|||||TWO_SIDED|95.0|0.8|1.0||||||aQIV GMT ratio (High risk/Healthy) for A/H1N1 at D22/50 (Pooled Naïve \& Non-naïve).||1.0|0.8|
72599509|NCT01964989|144729410|OTHER||GMT ratio|1.02|||||TWO_SIDED|95.0|0.9|1.1||||||aQIV GMT ratio (High risk/Healthy) for A/H3N2 at D22/50 (Pooled Naïve \& Non-naïve).||1.1|0.9|
72599510|NCT01964989|144729410|OTHER||GMT ratio|0.98|||||TWO_SIDED|95.0|0.8|1.1||||||aQIV GMT ratio (High risk/Healthy) for B/YAM at D22/50 (Pooled Naïve \& Non-naïve).||1.1|0.8|
72599511|NCT01964989|144729410|OTHER||GMT ratio|0.92|||||TWO_SIDED|95.0|0.8|1.1||||||aQIV GMT ratio (High risk/Healthy) for B/VIC at D22/50 (Pooled Naïve \& Non-naïve).||1.1|0.8|
72599512|NCT01964989|144729410|OTHER||GMT ratio|0.95|||||TWO_SIDED|95.0|0.8|1.1||||||TIV/QIV GMT ratio (High risk/Healthy) for A/H1N1 at D22/50 (Pooled Naïve \& Non-naïve).||1.1|0.8|
72599513|NCT01964989|144729410|OTHER||GMT ratio|0.98|||||TWO_SIDED|95.0|0.8|1.1||||||TIV/QIV GMT ratio (High risk/Healthy) for A/H3N2 at D22/50 (Pooled Naïve \& Non-naïve).||1.1|0.8|
72599514|NCT01964989|144729410|OTHER||GMT ratio|0.95|||||TWO_SIDED|95.0|0.8|1.1||||||TIV/QIV GMT ratio (High risk/Healthy) for B/YAM at D22/50 (Pooled Naïve \& Non-naïve).||1.1|0.8|
72599515|NCT01964989|144729410|OTHER||GMT ratio|0.92|||||TWO_SIDED|95.0|0.7|1.2||||||TIV/QIV GMT ratio (High risk/Healthy) for B/VIC at D22/50 (Pooled Naïve \& Non-naïve).||1.2|0.7|
72415850|NCT02701985|144342650|SUPERIORITY||Median Difference (Final Values)|0.87||||0.4266||95.0|-1.3|3.03|||Mixed Model of Repeated Measures|||A Mixed Model for Repeated Measures (MMRM) approach incorporating all observed data up to 12 weeks of treatment was used. The MMRM included the absolute change from baseline as the dependent variable.||3.03|-1.30|0.4266
72599516|NCT01964989|144729412|SUPERIORITY|Superiority criterion: The lower bound of the two-sided 95% CI on the unadjusted difference of percentages of subjects seroconverted for HI antibody exceeds 0%.|Seroconversion difference|8.2|||||TWO_SIDED|95.0|5.0|11.3||||||Seroconversion difference (aQIV - Comparator \[TIV/QIV\]) for A/H1N1.||11.3|5.0|
72599517|NCT01964989|144729412|SUPERIORITY|Superiority criterion: The lower bound of the two-sided 95% CI on the unadjusted difference of percentages of subjects seroconverted for HI antibody exceeds 0%.|Seroconversion difference|5.2|||||TWO_SIDED|95.0|1.9|8.4||||||Seroconversion difference (aQIV - Comparator \[TIV/QIV\]) for A/H3N2.||8.4|1.9|
72599518|NCT01964989|144729412|SUPERIORITY||Seroconversion difference|21.3|||||TWO_SIDED|95.0|18.1|24.5||||||Seroconversion difference (aQIV - Comparator \[TIV/QIV\]) for B/YAM.||24.5|18.1|
72599519|NCT01964989|144729412|SUPERIORITY|Superiority criterion: The lower bound of the two-sided 95% CI on the unadjusted difference of percentages of subjects seroconverted for HI antibody exceeds 0%.|Seroconversion difference|13.6|||||TWO_SIDED|95.0|10.0|17.3||||||Seroconversion difference (aQIV - Comparator \[TIV/QIV\]) for B/VIC.||17.3|10.0|
72599520|NCT01964989|144729413|OTHER||Mean Difference (Final Values)|11.5|||||TWO_SIDED|95.0|9.4|13.7||||||Difference in HI titers ≥ 1:40 (aQIV - Comparator \[TIV/QIV\]) for A/H1N1.||13.7|9.4|
72599521|NCT01964989|144729413|OTHER||Mean Difference (Final Values)|7.8|||||TWO_SIDED|95.0|6.1|9.7||||||Difference in HI titers ≥ 1:40 (aQIV - Comparator \[TIV/QIV\]) for A/H3N2.||9.7|6.1|
72599522|NCT01964989|144729413|OTHER||Mean Difference (Final Values)|21.9|||||TWO_SIDED|95.0|18.1|25.6||||||Difference in HI titers ≥ 1:40 (aQIV - Comparator \[TIV/QIV\]) for B/YAM.||25.6|18.1|
72599523|NCT01964989|144729413|OTHER||Mean Difference (Final Values)|20.9|||||TWO_SIDED|95.0|15.9|25.7||||||Difference in HI titers ≥ 1:40 (aQIV - Comparator \[TIV/QIV\]) for B/VIC.||25.7|15.9|
72599524|NCT01964989|144729414|OTHER||Mean Difference (Final Values)|7.8|||||TWO_SIDED|95.0|5.9|9.7||||||Difference in HI titers ≥ 1:110 for A/H1N1 (aQIV - Comparator \[TIV/QIV\]) at Day 22/50.||9.7|5.9|
72599525|NCT01964989|144729414|OTHER||Mean Difference (Final Values)|9.8|||||TWO_SIDED|95.0|7.8|11.9||||||Difference in HI Titers ≥ 1:151 for A/H1N1 (aQIV - Comparator \[TIV/QIV\]) at Day 22/50.||11.9|7.8|
72599526|NCT01964989|144729414|OTHER||Mean Difference (Final Values)|16.1|||||TWO_SIDED|95.0|13.5|18.7||||||Difference in HI Titers ≥ 1:215 for A/H1N1 (aQIV - Comparator \[TIV/QIV\]) at Day 22/50.||18.7|13.5|
72599527|NCT01964989|144729414|OTHER||Mean Difference (Final Values)|23.1|||||TWO_SIDED|95.0|19.8|26.4||||||Difference in HI Titers ≥ 1:330 for A/H1N1 (aQIV - Comparator \[TIV/QIV\]) at Day 22/50.||26.4|19.8|
72599528|NCT01964989|144729414|OTHER||Mean Difference (Final Values)|24.1|||||TWO_SIDED|95.0|20.6|27.6||||||Difference in HI Titers ≥ 1:629 for A/H1N1 (aQIV - Comparator \[TIV/QIV\]) at Day 22/50.||27.6|20.6|
72599529|NCT01964989|144729414|OTHER||Mean Difference (Final Values)|5.9|||||TWO_SIDED|95.0|4.5|7.5||||||Difference in HI Titers ≥ 1:110 for A/H3N2 (aQIV - Comparator \[TIV/QIV\]) at Day 22/50.||7.5|4.5|
72599530|NCT01964989|144729414|OTHER||Mean Difference (Final Values)|7.8|||||TWO_SIDED|95.0|6.1|9.6||||||Difference in HI Titers ≥ 1:151 for A/H3N2 (aQIV - Comparator \[TIV/QIV\]) at Day 22/50.||9.6|6.1|
72599531|NCT01964989|144729414|OTHER||Mean Difference (Final Values)|11.7|||||TWO_SIDED|95.0|9.6|13.9||||||Difference in HI Titers ≥ 1:215 for A/H3N2 (aQIV - Comparator \[TIV/QIV\]) at Day 22/50.||13.9|9.6|
72599532|NCT01964989|144729414|OTHER||Mean Difference (Final Values)|19.0|||||TWO_SIDED|95.0|16.1|22.0||||||Difference in HI Titers ≥ 1:330 for A/H3N2 (aQIV - Comparator \[TIV/QIV\]) at Day 22/50.||22.0|16.1|
72599533|NCT01964989|144729414|OTHER||Mean Difference (Final Values)|21.1|||||TWO_SIDED|95.0|17.8|24.3||||||Difference in HI Titers ≥ 1:629 for A/H3N2 (aQIV - Comparator \[TIV/QIV\]) at Day 22/50.||24.3|17.8|
72599534|NCT01964989|144729414|OTHER||Mean Difference (Final Values)|28.8|||||TWO_SIDED|95.0|25.1|32.3||||||Difference in HI Titers ≥ 1:110 for B/YAM (aQIV - Comparator \[TIV/QIV\]) at Day 22/50.||32.3|25.1|
72599535|NCT01964989|144729414|OTHER||Mean Difference (Final Values)|26.3|||||TWO_SIDED|95.0|22.6|29.9||||||Difference in HI Titers ≥ 1:151 for B/YAM (aQIV - Comparator \[TIV/QIV\]) at Day 22/50.||29.9|22.6|
72599536|NCT01964989|144729414|OTHER||Mean Difference (Final Values)|21.8|||||TWO_SIDED|95.0|18.3|25.3||||||Difference in HI Titers ≥ 1:215 for B/YAM (aQIV - Comparator \[TIV/QIV\]) at Day 22/50.||25.3|18.3|
72599537|NCT01964989|144729414|OTHER||Mean Difference (Final Values)|11.6|||||TWO_SIDED|95.0|8.6|14.5||||||Difference in HI Titers ≥ 1:330 for B/YAM (aQIV - Comparator \[TIV/QIV\]) at Day 22/50.||14.5|8.6|
72599538|NCT01964989|144729414|OTHER||Mean Difference (Final Values)|6.8|||||TWO_SIDED|95.0|4.3|9.4||||||Difference in HI Titers ≥ 1:629 for B/YAM (aQIV - Comparator \[TIV/QIV\]) at Day 22/50.||9.4|4.3|
72599539|NCT03441685|144729424|OTHER|Accuracy identifying taught verbs in syntactic vs semantic condition (receptive)||||||0.73||||||Asymptotic p-value|Wilcoxon Signed Ranks Test|||||||0.73
72599540|NCT03441685|144729424|OTHER|Accuracy identifying taught verbs in syntactic vs semantic condition (receptive)||||||0.69||||||Asymptotic p-value|Wilcoxon Signed Ranks Test|||||||0.69
72599541|NCT03441685|144729424|OTHER|Accuracy identifying taught verbs in syntactic vs semantic condition (receptive)||||||0.79||||||Asymptotic p-value|Wilcoxon Signed Ranks Test|||||||0.79
72599542|NCT03441685|144729424|OTHER|One-sample Wilcoxon signed rank test with comparison value of 6.||||||0.002||||||Asymptotic p-value|One-sample Wilcoxon signed rank test|||||||0.002
72599543|NCT03441685|144729424|OTHER|One-sample Wilcoxon signed rank test with comparison value of 6.||||||0.049||||||Asymptotic p-value|One-sample Wilcoxon signed rank test|||||||0.049
72599544|NCT03441685|144729424|OTHER|One-sample Wilcoxon signed rank test with comparison value of 6.||||||0.016||||||Asymptotic p-value|One-sample Wilcoxon signed rank test|||||||0.016
72599545|NCT03441685|144729425|OTHER|Accuracy identifying taught verbs in semantic vs combined condition (receptive)||||||0.76||||||Asymptotic p-value|Wilcoxon Signed Ranks Test|||||||0.76
72599546|NCT03441685|144729425|OTHER|Accuracy identifying taught verbs in semantic vs combined condition (receptive)||||||0.79||||||Asymptotic p-value|Wilcoxon Signed Ranks Test|||||||0.79
72599547|NCT03441685|144729425|OTHER|Accuracy identifying taught verbs in semantic vs combined condition (receptive)||||||1||||||Asymptotic p-value|Wilcoxon Signed Ranks Test|||||||1.00
72599548|NCT03441685|144729425|OTHER|One-sample Wilcoxon signed rank test with comparison value of 6.||||||0.003||||||Asymptotic p-value|One-sample Wilcoxon signed rank test|||||||0.003
72599549|NCT03441685|144729425|OTHER|One-sample Wilcoxon signed rank test with comparison value of 6.||||||0.029||||||Asymptotic p-value|One-sample Wilcoxon signed rank test|||||||0.029
72599550|NCT03441685|144729425|OTHER|One-sample Wilcoxon signed rank test with comparison value of 6.||||||0.027||||||Asymptotic p-value|One-sample Wilcoxon signed rank test|||||||0.027
72599551|NCT03441685|144729426|OTHER|Accuracy identifying taught verbs in syntactic vs combined condition (receptive)||||||0.72||||||Asymptotic p-value|Wilcoxon Signed Ranks Test|||||||0.72
72599552|NCT03441685|144729426|OTHER|Accuracy identifying taught verbs in syntactic vs combined condition (receptive)||||||0.46||||||Asymptotic p-value|Wilcoxon Signed Ranks Test|||||||0.46
72599553|NCT03441685|144729426|OTHER|Accuracy identifying taught verbs in syntactic vs combined condition (receptive)||||||0.89||||||Asymptotic p-value|Wilcoxon Signed Ranks Test|||||||0.89
72599554|NCT03441685|144729426|OTHER|One-sample Wilcoxon signed rank test with comparison value of 6.|||||<|0.001||||||Asymptotic p-value|One-sample Wilcoxon signed rank test|||||||<.001
72599555|NCT03441685|144729426|OTHER|One-sample Wilcoxon signed rank test with comparison value of 6.||||||0.018||||||Asymptotic p-value|One-sample Wilcoxon signed rank test|||||||0.018
72599556|NCT03441685|144729426|OTHER|One-sample Wilcoxon signed rank test with comparison value of 6.||||||0.027||||||Asymptotic p-value|One-sample Wilcoxon signed rank test|||||||0.027
72599557|NCT03441685|144729427|OTHER|Accuracy labeling taught verbs in syntactic vs semantic condition (expressive)||||||0.64||||||Asymptotic p-value|Wilcoxon Signed Ranks Test|||||||0.64
72599558|NCT03441685|144729427|OTHER|Accuracy labeling taught verbs in syntactic vs semantic condition (expressive)||||||0.16||||||Asymptotic p-value|Wilcoxon Signed Ranks Test|||||||0.16
72599559|NCT03441685|144729427|OTHER|Accuracy labeling taught verbs in syntactic vs semantic condition (expressive)||||||0.18||||||Asymptotic p-value|Wilcoxon Signed Ranks Test|||||||0.18
72599560|NCT03441685|144729427|OTHER|One-sample Wilcoxon signed rank test with comparison value of 0|||||<|0.001||||||Asymptotic p-value|One-sample Wilcoxon signed rank test|||||||<.001
72599561|NCT03441685|144729427|OTHER|One-sample Wilcoxon signed rank test with comparison value of 0||||||0.034||||||Asymptotic p-value|One-sample Wilcoxon signed rank test|||||||0.034
72599562|NCT03441685|144729427|OTHER|One-sample Wilcoxon signed rank test with comparison value of 0||||||0.063||||||Asymptotic p-value|One-sample Wilcoxon signed rank test|||||||0.063
72599563|NCT03441685|144729428|OTHER|Accuracy labeling taught verbs in semantic vs combined condition (expressive)||||||0.35||||||Asymptotic p-value|Wilcoxon Signed Ranks Test|||||||0.35
72599564|NCT03441685|144729428|OTHER|Accuracy labeling taught verbs in semantic vs combined condition (expressive)||||||0.18||||||Asymptotic p-value|Wilcoxon Signed Ranks Test|||||||0.18
72599565|NCT03441685|144729428|OTHER|Accuracy labeling taught verbs in semantic vs combined condition (expressive)||||||0.58|||||||Wilcoxon Signed Ranks Test|||||||0.58
72599566|NCT03441685|144729428|OTHER|One-sample Wilcoxon signed rank test with comparison value of 0||||||0.006||||||Asymptotic p-value|One-sample Wilcoxon signed rank test|||||||0.006
72599567|NCT03441685|144729428|OTHER|One-sample Wilcoxon signed rank test with comparison value of 0||||||0.02||||||Asymptotic p-value|One-sample Wilcoxon signed rank test|||||||0.02
72599568|NCT03441685|144729428|OTHER|One-sample Wilcoxon signed rank test with comparison value of 0||||||0.18||||||Asymptotic p-value|One-sample Wilcoxon signed rank test|||||||0.18
72599569|NCT03441685|144729429|OTHER|Accuracy labeling taught verbs in syntactic vs combined condition (expressive)||||||0.56||||||Asymptotic p-value|Wilcoxon Signed Ranks Test|||||||0.56
72599570|NCT03441685|144729429|OTHER|Accuracy labeling taught verbs in syntactic vs combined condition (expressive)||||||0.1||||||Asymptotic p-value|Wilcoxon Signed Ranks Test|||||||0.10
72599571|NCT03441685|144729429|OTHER|Accuracy labeling taught verbs in syntactic vs combined condition (expressive)||||||0.71||||||Asymptotic p-value|Wilcoxon Signed Ranks Test|||||||0.71
72599572|NCT03441685|144729429|OTHER|One-sample Wilcoxon signed rank test with comparison value of 0|||||<|0.001||||||Asymptotic p-value|One-sample Wilcoxon signed rank test|||||||<.001
72599573|NCT03441685|144729429|OTHER|One-sample Wilcoxon signed rank test with comparison value of 0||||||0.024||||||Asymptotic p-value|One-sample Wilcoxon signed rank test|||||||0.024
72415851|NCT02701985|144342651|SUPERIORITY||Mean Difference (Final Values)|0.06||||0.6429||95.0|-0.21|0.34|||Mixed Model of Repeated Measures|||A Mixed Model for Repeated Measures (MMRM) approach incorporating all observed data up to 12 weeks of treatment was used. The MMRM included the absolute change from baseline as the dependent variable.||0.34|-0.21|0.6429
72415852|NCT01640808|144342669|SUPERIORITY||Hazard Ratio (HR)|0.9||||0.351|TWO_SIDED|95.0|0.72|1.124||A two-sided significance level was set at 0.05. Adjustment of multiplicity considering interim analysis is conducted by the Lan DeMets' method of α consumption function.|Log Rank|||||1.124|0.720|0.351
72415853|NCT01640808|144342670|SUPERIORITY||Hazard Ratio (HR)|0.875||||0.222|TWO_SIDED|95.0|0.706|1.085||A two-sided significance level was set at 0.05.|Log Rank|||||1.085|0.706|0.222
72599574|NCT03441685|144729429|OTHER|One-sample Wilcoxon signed rank test with comparison value of 0||||||0.1||||||Asymptotic p-value|One-sample Wilcoxon signed rank test|||||||0.10
72599575|NCT00424593|144729433|SUPERIORITY_OR_OTHER|||||||0.004||95.0||||Model included treatment, non-steriodal anti-inflammatory drug (NSAID) use (Yes/No), investigator, visit, treatment-by-visit interaction, baseline pain severity, and baseline-by-visit interaction.|Repeated Measures Analysis|||||||0.004
72599576|NCT00424593|144729434|SUPERIORITY_OR_OTHER|||||||0.014||95.0|||||ANCOVA|||||||0.014
72599577|NCT00424593|144729435|SUPERIORITY_OR_OTHER|||||||0.009||95.0||||P-value is for 13 Week Change from Baseline.|ANCOVA|||||||0.009
72599578|NCT00424593|144729436|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||P-value for Average Pain Score Change from Baseline.|ANCOVA|||||||0.002
72599579|NCT00424593|144729436|SUPERIORITY_OR_OTHER|||||||0.014||95.0||||P-value for Worst Pain Score Change from Baseline.|ANCOVA|||||||0.014
72599580|NCT00424593|144729436|SUPERIORITY_OR_OTHER|||||||0.007||95.0||||P-value for Night Pain Score Change from Baseline.|ANCOVA|||||||0.007
72599581|NCT00424593|144729437|SUPERIORITY_OR_OTHER|||||||0.011||95.0||||P-value for Worst Pain Score Week 13 Change from Baseline.|ANCOVA|||||||0.011
72599582|NCT00424593|144729437|SUPERIORITY_OR_OTHER|||||||0.001||95.0||||P-value for Least Pain Score Week 13 Change from Baseline.|ANCOVA|||||||0.001
72599583|NCT00424593|144729437|SUPERIORITY_OR_OTHER|||||||0.019||95.0||||P-value for Average Pain Score Week 13 Change from Baseline.|ANCOVA|||||||0.019
72599584|NCT00424593|144729437|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||P-value for Pain Right Now Score Week 13 Change from Baseline.|ANCOVA|||||||0.002
72599585|NCT00424593|144729437|SUPERIORITY_OR_OTHER|||||||0.068||95.0||||P-value for General Activity Week 13 Change from Baseline.|ANCOVA|||||||0.068
72415854|NCT01640808|144342671|SUPERIORITY||Hazard Ratio (HR)|0.882||||0.279|TWO_SIDED|95.0|0.703|1.108||A two-sided significance level was set at 0.05.|Log Rank|||||1.108|0.703|0.279
72599586|NCT00424593|144729437|SUPERIORITY_OR_OTHER|||||||0.009||95.0||||P-value for Mood Week 13 Change from Baseline.|ANCOVA|||||||0.009
72599587|NCT00424593|144729437|SUPERIORITY_OR_OTHER|||||||0.006||95.0||||P-value for Walking Ability Week 13 Change from Baseline.|ANCOVA|||||||0.006
72599588|NCT00424593|144729437|SUPERIORITY_OR_OTHER|||||||0.024||95.0||||P-value for Normal Work Week 13 Change from Baseline.|ANCOVA|||||||0.024
72599589|NCT00424593|144729437|SUPERIORITY_OR_OTHER|||||||0.005||95.0||||P-value for Relations With People Week 13 Change from Baseline.|ANCOVA|||||||0.005
72599590|NCT00424593|144729437|SUPERIORITY_OR_OTHER|||||||0.051||95.0||||P-value for Sleep Week 13 Change from Baseline.|ANCOVA|||||||0.051
72599591|NCT00424593|144729437|SUPERIORITY_OR_OTHER|||||||0.013||95.0||||P-value for Enjoyment of Life Week 13 Change from Baseline.|ANCOVA|||||||0.013
72599592|NCT00424593|144729437|SUPERIORITY_OR_OTHER|||||||0.005||95.0||||P-value for Average Interference Week 13 Change from Baseline.|ANCOVA|||||||0.005
72599593|NCT00424593|144729438|SUPERIORITY_OR_OTHER|||||||0.092||95.0||||P-value for Week 13 Change from Baseline.|ANCOVA|||||||0.092
72599594|NCT00424593|144729439|SUPERIORITY_OR_OTHER|||||||0.06||95.0|||||Fisher Exact|||||||0.060
72599595|NCT00424593|144729440|SUPERIORITY_OR_OTHER|||||||0.087||95.0|||||Fisher Exact|||||||0.087
72599596|NCT00424593|144729441|SUPERIORITY_OR_OTHER|||||||0.329||95.0||||P-value for Week 13 Change from Baseline.|ANCOVA|||||||0.329
72599597|NCT00424593|144729442|SUPERIORITY_OR_OTHER|||||||0.051||95.0||||P-value for Mental Component Summary Change from Baseline.|ANCOVA|||||||0.051
72599598|NCT00424593|144729442|SUPERIORITY_OR_OTHER|||||||0.22||95.0||||P-value for Physical Component Summary Change from Baseline.|ANCOVA|||||||0.220
72599599|NCT00424593|144729442|SUPERIORITY_OR_OTHER|||||||0.038||95.0||||P-value for Bodily Pain Change from Baseline.|ANCOVA|||||||0.038
72599600|NCT00424593|144729442|SUPERIORITY_OR_OTHER|||||||0.041||95.0||||P-value for General Health Change from Baseline.|ANCOVA|||||||0.041
72599601|NCT00424593|144729442|SUPERIORITY_OR_OTHER|||||||0.093||95.0||||P-value for Mental Health Change from Baseline.|ANCOVA|||||||0.093
72599602|NCT00424593|144729442|SUPERIORITY_OR_OTHER|||||||0.21||95.0||||P-value for Physical Functioning Change from Baseline.|ANCOVA|||||||0.210
72415855|NCT01869491|144342672|SUPERIORITY||Mean Difference (Final Values)|-0.21|||<|0.0001|TWO_SIDED|95.0|-0.31|-0.11|||Mixed Models Analysis|||||-0.11|-0.31|<0.0001
72415856|NCT01869491|144342673|SUPERIORITY||Mean Difference (Final Values)|-0.18||||0.0004|TWO_SIDED|95.0|-0.29|-0.08|||Mixed Models Analysis|||||-0.08|-0.29|0.0004
72415857|NCT01869491|144342674|SUPERIORITY||Mean Difference (Final Values)|-0.21||||0.0001|TWO_SIDED|95.0|-0.32|-0.1|||Mixed Models Analysis|||||-0.10|-0.32|0.0001
72599603|NCT00424593|144729442|SUPERIORITY_OR_OTHER|||||||0.17||95.0||||P-value for Role-Emotional Change from Baseline.|ANCOVA|||||||0.170
72599604|NCT00424593|144729442|SUPERIORITY_OR_OTHER|||||||0.306||95.0||||P-value for Role-Physical Change from Baseline.|ANCOVA|||||||0.306
72599605|NCT00424593|144729442|SUPERIORITY_OR_OTHER|||||||0.053||95.0||||P-value for Social Functioning Change from Baseline.|ANCOVA|||||||0.053
72599606|NCT00424593|144729442|SUPERIORITY_OR_OTHER|||||||0.04||95.0||||P-value for Vitality Change from Baseline.|ANCOVA|||||||0.040
72599607|NCT00424593|144729443|SUPERIORITY_OR_OTHER|||||||0.117||95.0||||P-value for Change from Baseline.|ANCOVA|||||||0.117
72599608|NCT00424593|144729444|SUPERIORITY_OR_OTHER|||||||0.063||95.0||||P-value for Absenteeism Week 13 Change from Baseline.|ANCOVA|||||||0.063
72599609|NCT00424593|144729444|SUPERIORITY_OR_OTHER|||||||0.452||95.0||||P-value for Presenteeism Week 13 Change from Baseline.|ANCOVA|||||||0.452
72599610|NCT00424593|144729444|SUPERIORITY_OR_OTHER|||||||0.736||95.0||||P-value for Work Productivity Loss Week 13 Change from Baseline.|ANCOVA|||||||0.736
72599611|NCT00424593|144729444|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||P-value for Work Activity Impairment Week 13 Change from Baseline.|ANCOVA|||||||0.002
72599612|NCT00424593|144729445|SUPERIORITY_OR_OTHER|||||||0.177||95.0||||P-value for Week 13 Change from Baseline.|ANCOVA|||||||0.177
72599613|NCT00424593|144729446|SUPERIORITY_OR_OTHER|||||||0.122||95.0||||P-value for Anxiety Subscale Change from Baseline.|ANCOVA|||||||0.122
72599614|NCT00424593|144729446|SUPERIORITY_OR_OTHER|||||||0.262||95.0||||P-value for Depression Subscale Change from Baseline.|ANCOVA|||||||0.262
72599615|NCT00424593|144729447|SUPERIORITY_OR_OTHER|||||||0.046||95.0||||P-value for Change from Baseline.|ANOVA|ANOVA based on rank transformation.||||||0.046
72599616|NCT00424593|144729448|SUPERIORITY_OR_OTHER|||||||0.008||95.0||||P-value for Change from Baseline.|ANOVA|ANOVA based on rank transformation.||||||0.008
72415858|NCT01869491|144342675|SUPERIORITY||Mean Difference (Final Values)|-0.21||||0.0004|TWO_SIDED|95.0|-0.32|-0.09|||Mixed Models Analysis|||||-0.09|-0.32|0.0004
72415859|NCT01869491|144342676|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
72415860|NCT01869491|144342677|SUPERIORITY|||||||0.0433|||||||Wilcoxon (Mann-Whitney)|||||||0.0433
72415861|NCT01869491|144342678|SUPERIORITY|||||||0.0503|||||||Wilcoxon (Mann-Whitney)|||||||0.0503
72599617|NCT00424593|144729449|SUPERIORITY_OR_OTHER|||||||0.028||95.0||||P-value for Week 13 Change from Baseline.|ANOVA|||||||0.028
72599618|NCT00424593|144729450|SUPERIORITY_OR_OTHER|||||||0.764||95.0||||P-value for SBP Week 13 Change from Baseline.|ANOVA|||||||0.764
72599619|NCT00424593|144729450|SUPERIORITY_OR_OTHER|||||||0.093||95.0||||P-value for DBP Week 13 Change from Baseline.|ANOVA|||||||0.093
72599620|NCT00424593|144729451|SUPERIORITY_OR_OTHER|||||||0.008||95.0||||P-value for Week 13 Change from Baseline.|ANOVA|||||||0.008
72599621|NCT01796301|144729454|SUPERIORITY|A two-step, step-down, fixed-sequential testing procedure was used to test the primary and key secondary efficacy endpoints for the comparison of romosozumab to teriparatide in the order presented for multiplicity adjustment to maintain the overall significance level at 0.05. The Key Secondary Efficacy Endpoints are the first 8 secondary endpoints reported below.|Treatment difference|3.2|STANDARD_ERROR_OF_MEAN|0.3|<|0.0001|TWO_SIDED|95.0|2.7|3.8|||Linear mixed effects repeated measures|||The primary analysis to assess the treatment difference (Romosozumab - Teriparatide) employed a linear mixed effects model for repeated measures. The model included main effects for treatment group, visit (categorical), baseline sCTX, baseline hip DXA BMD value, machine type (categorical), and machine type-by-baseline value interaction (to adjust for the effect of machine type on baseline DXA BMD value) as fixed main effects using an unstructured within-subject variance-covariance structure.||3.8|2.7|< 0.0001
72599622|NCT01796301|144729455|SUPERIORITY||Treatment difference|3.1|STANDARD_ERROR_OF_MEAN|0.3|<|0.0001|TWO_SIDED|95.0|2.5|3.7|||Linear mixed effects repeated measures|||Treatment difference (Romosozumab - Teriparatide) was analyzed using a linear mixed effects model for repeated measures adjusting for treatment, visit, baseline serum type 1 collagen C-telopeptide value, baseline BMD value, machine type, baseline BMD value-by machine type interaction, treatment-by-visit interaction, and using an unstructured variance covariance structure.||3.7|2.5|< 0.0001
72599623|NCT01796301|144729456|SUPERIORITY||Treatment difference|3.4|STANDARD_ERROR_OF_MEAN|0.3|<|0.0001|TWO_SIDED|95.0|2.8|4.0|||Linear mixed effects repeated measures|||Treatment difference (Romosozumab - Teriparatide) was analyzed using a linear mixed effects model for repeated measures adjusting for treatment, visit, baseline serum type 1 collagen C-telopeptide value, baseline BMD value, machine type, baseline BMD value-by machine type interaction, treatment-by-visit interaction, and using an unstructured variance covariance structure.||4.0|2.8|< 0.0001
72599624|NCT01796301|144729457|SUPERIORITY||Treatment difference|3.4|STANDARD_ERROR_OF_MEAN|0.3|<|0.0001|TWO_SIDED|95.0|2.8|4.0|||Linear mixed effects repeated measures|||Treatment difference (Romosozumab - Teriparatide) was analyzed using a linear mixed effects model for repeated measures adjusting for treatment, visit, baseline serum type 1 collagen C-telopeptide value, parameter baseline value, treatment-by visit interaction, and using an unstructured variance covariance structure.||4.0|2.8|< 0.0001
72599625|NCT01796301|144729458|SUPERIORITY||Treatment difference|4.6|STANDARD_ERROR_OF_MEAN|0.4|<|0.0001|TWO_SIDED|95.0|3.9|5.3|||Linear mixed effects repeated measures|||Treatment difference (Romosozumab - Teriparatide) was analyzed using a linear mixed effects model for repeated measures adjusting for treatment, visit, baseline serum type 1 collagen C-telopeptide value, parameter baseline value, treatment-by visit interaction, and using an unstructured variance covariance structure.||5.3|3.9|< 0.0001
72599626|NCT01796301|144729459|SUPERIORITY||Treatment difference|3.1|STANDARD_ERROR_OF_MEAN|0.3|<|0.0001|TWO_SIDED|95.0|2.5|3.6|||Linear mixed effects repeated measures|||Treatment difference (Romosozumab - Teriparatide) was analyzed using a linear mixed effects model for repeated measures adjusting for treatment, visit, baseline serum type 1 collagen C-telopeptide value, parameter baseline value, treatment-by visit interaction, and using an unstructured variance covariance structure.||3.6|2.5|< 0.0001
72599627|NCT01796301|144729460|SUPERIORITY||Treatment difference|3.6|STANDARD_ERROR_OF_MEAN|0.3|<|0.0001|TWO_SIDED|95.0|2.9|4.2|||Linear mixed effects repeated measures|||Treatment difference (Romosozumab - Teriparatide) was analyzed using a linear mixed effects model for repeated measures adjusting for treatment, visit, baseline serum type 1 collagen C-telopeptide value, parameter baseline value, treatment-by visit interaction, and using an unstructured variance covariance structure.||4.2|2.9|< 0.0001
72599628|NCT01796301|144729461|SUPERIORITY||Treatment difference|3.1|STANDARD_ERROR_OF_MEAN|0.3|<|0.0001|TWO_SIDED|95.0|2.4|3.8|||Linear mixed effects repeated measures|||Treatment difference (Romosozumab - Teriparatide) was analyzed using a linear mixed effects model for repeated measures adjusting for treatment, visit, baseline serum type 1 collagen C-telopeptide value, parameter baseline value, treatment-by visit interaction, and using an unstructured variance covariance structure.||3.8|2.4|< 0.0001
72415862|NCT04009291|144342679|SUPERIORITY||||||=|0.2635|||||||t-test, 2 sided|||Fisher's exact test is used to compare differences in the proportion of subjects meeting the composite primary endpoint in the TransCon PTH versus pooled placebo group||||= 0.2635
72599629|NCT01796301|144729462|SUPERIORITY||Treatment difference|3.2|STANDARD_ERROR_OF_MEAN|0.6|<|0.0001|TWO_SIDED|95.0|2.1|4.3|||Linear mixed effects repeated measures|||Treatment difference (Romosozumab - Teriparatide) was analyzed using a linear mixed effects model for repeated measures adjusting for treatment, visit, baseline serum type 1 collagen C-telopeptide value, parameter baseline value, treatment-by visit interaction, and using an unstructured variance covariance structure.||4.3|2.1|< 0.0001
72599630|NCT01796301|144729463|SUPERIORITY||Treatment difference|3.1|STANDARD_ERROR_OF_MEAN|0.3|<|0.0001|TWO_SIDED|95.0|2.6|3.6|||Linear mixed effects repeated measures|||Treatment difference (Romosozumab - Teriparatide) was analyzed using a linear mixed effects model for repeated measures adjusting for treatment, visit, baseline serum type 1 collagen C-telopeptide value, parameter baseline value, treatment-by visit interaction, and using an unstructured variance covariance structure.||3.6|2.6|< 0.0001
72599631|NCT01796301|144729464|SUPERIORITY||Treatment difference|3.6|STANDARD_ERROR_OF_MEAN|0.3|<|0.0001|TWO_SIDED|95.0|2.9|4.2|||Linear mixed effects repeated measures|||Treatment difference (Romosozumab - Teriparatide) was analyzed using a linear mixed effects model for repeated measures adjusting for treatment, visit, baseline serum type 1 collagen C-telopeptide value, parameter baseline value, treatment-by visit interaction, and using an unstructured variance covariance structure.||4.2|2.9|< 0.0001
72599632|NCT01796301|144729465|SUPERIORITY||Treatment difference|3.2|STANDARD_ERROR_OF_MEAN|0.4|<|0.0001|TWO_SIDED|95.0|2.5|3.9|||Linear mixed effects repeated measures|||Treatment difference (Romosozumab - Teriparatide) was analyzed using a linear mixed effects model for repeated measures adjusting for treatment, visit, baseline serum type 1 collagen C-telopeptide value, baseline BMD value, machine type, baseline BMD value-by machine type interaction, treatment-by-visit interaction, and using an unstructured variance covariance structure.||3.9|2.5|< 0.0001
72599633|NCT01796301|144729466|SUPERIORITY||Treatment difference|3.4|STANDARD_ERROR_OF_MEAN|0.4|<|0.0001|TWO_SIDED|95.0|2.6|4.2|||Linear mixed effects repeated measures|||Treatment difference (Romosozumab - Teriparatide) was analyzed using a linear mixed effects model for repeated measures adjusting for treatment, visit, baseline serum type 1 collagen C-telopeptide value, baseline BMD value, machine type, baseline BMD value-by machine type interaction, treatment-by-visit interaction, and using an unstructured variance covariance structure.||4.2|2.6|< 0.0001
72599634|NCT01796301|144729467|SUPERIORITY||Treatment difference|3.8|STANDARD_ERROR_OF_MEAN|0.4|<|0.0001|TWO_SIDED|95.0|2.9|4.6|||Linear mixed effects repeated measures|||Treatment difference (Romosozumab - Teriparatide) was analyzed using a linear mixed effects model for repeated measures adjusting for treatment, visit, baseline serum type 1 collagen C-telopeptide value, baseline BMD value, machine type, baseline BMD value-by machine type interaction, treatment-by-visit interaction, and using an unstructured variance covariance structure.||4.6|2.9|< 0.0001
72599635|NCT01796301|144729468|SUPERIORITY||Treatment difference|4.4|STANDARD_ERROR_OF_MEAN|0.5|<|0.0001|TWO_SIDED|95.0|3.4|5.4|||Linear mixed effects repeated measures|||Treatment difference (Romosozumab - Teriparatide) was analyzed using a linear mixed effects model for repeated measures adjusting for treatment, visit, baseline serum type 1 collagen C-telopeptide value, baseline BMD value, machine type, baseline BMD value-by machine type interaction, treatment-by-visit interaction, and using an unstructured variance covariance structure.||5.4|3.4|< 0.0001
72599636|NCT02756819|144729485|OTHER||||||<|0.001||||||P-value was reported for Change at Month 6 relative to Baseline.|Wilcoxon test|||||||<0.001
72415863|NCT04009291|144342679|SUPERIORITY||||||=|0.6999|||||||t-test, 2 sided|||Fisher's exact test is used to compare differences in the proportion of subjects meeting the composite primary endpoint in the TransCon PTH versus pooled placebo group||||= 0.6999
72415864|NCT04009291|144342679|SUPERIORITY||||||=|0.1394|||||||t-test, 2 sided|||Fisher's exact test is used to compare differences in the proportion of subjects meeting the composite primary endpoint in the TransCon PTH versus pooled placebo group||||= 0.1394
72599637|NCT02756819|144729486|OTHER||||||<|0.001||||||P-value was reported for Change at Month 6 relative to Baseline.|Wilcoxon test|||||||<0.001
72599638|NCT02756819|144729489|OTHER||||||<|0.001||||||P-value was reported for Change from baseline at Month 6 (Overweight)|Wilcoxon test|||||||<0.001
72599639|NCT02756819|144729489|OTHER||||||<|0.001||||||P-value was reported for Change from baseline at Month 6 (Obesity class I)|Wilcoxon test|||||||<0.001
72599640|NCT02756819|144729489|OTHER||||||<|0.001||||||P-value was reported for Change from baseline at Month 6 (Obesity class II)|Wilcoxon test|||||||<0.001
72599641|NCT02756819|144729489|OTHER||||||<|0.001||||||P-value was reported for Change from baseline at Month 6 (Obesity class III)|Wilcoxon test|||||||<0.001
72599642|NCT02756819|144729489|OTHER||||||<|0.001|||||||Wilcoxon test|P-value was reported for Change from baseline at Month 6 (Normal glucose metabolism)||||||<0.001
72599643|NCT02756819|144729489|OTHER||||||<|0.001||||||P-value was reported for Change from baseline at Month 6 (Impaired glucose tolerance)|Wilcoxon test|||||||<0.001
72599644|NCT02756819|144729489|OTHER||||||<|0.001||||||P-value was reported for Change from baseline at Month 6 (Diabetes Mellitus - No)|Wilcoxon test|||||||<0.001
72599645|NCT02756819|144729489|OTHER||||||<|0.001||||||P-value was reported for Change from baseline at Month 6 (Diabetes Mellitus - Yes)|Wilcoxon test|||||||<0.001
72599646|NCT02756819|144729489|OTHER||||||<|0.001||||||P-value was reported for Change from baseline at Month 6 (Neither diabetes mellitus nor metabolic syndrome)|Wilcoxon test|||||||<0.001
72599647|NCT02756819|144729489|OTHER||||||<|0.001||||||P-value was reported for Change from baseline at Month 6 (Metabolic syndrome)|Wilcoxon test|||||||<0.001
72599648|NCT02756819|144729490|OTHER||||||<|0.001||||||P-value was reported for Change from baseline at Month 6 (Overweight)|Wilcoxon test|||||||<0.001
72599649|NCT02756819|144729490|OTHER||||||<|0.001||||||P-value was reported for Change from baseline at Month 6 (Obesity class I)|Wilcoxon test|||||||<0.001
72599650|NCT02756819|144729490|OTHER||||||<|0.001||||||P-value was reported for Change from baseline at Month 6 (Obesity class II)|Wilcoxon test|||||||<0.001
72599651|NCT02756819|144729490|OTHER||||||<|0.001||||||P-value was reported for Change from baseline at Month 6 (Obesity class III)|Wilcoxon test|||||||<0.001
72599652|NCT02756819|144729490|OTHER||||||<|0.001||||||P-value was reported for Change from baseline at Month 6 (Normal glucose metabolism)|Wilcoxon test|||||||<0.001
72599653|NCT02756819|144729490|OTHER||||||<|0.001||||||P-value was reported for Change from baseline at Month 6 (Impaired glucose tolerance)|Wilcoxon test|||||||<0.001
72599654|NCT02756819|144729490|OTHER||||||<|0.001||||||P-value was reported for Change from baseline at Month 6 (Diabetes Mellitus - No)|Wilcoxon test|||||||<0.001
72599655|NCT02756819|144729490|OTHER||||||<|0.001||||||P-value was reported for Change from baseline at Month 6 (Diabetes Mellitus - Yes)|Wilcoxon test|||||||<0.001
72599656|NCT02756819|144729490|OTHER||||||<|0.001||||||P-value was reported for Change from baseline at Month 6 (Neither diabetes mellitus nor metabolic syndrome)|Wilcoxon test|||||||<0.001
72599657|NCT02756819|144729490|OTHER||||||<|0.001||||||P-value was reported for Change from baseline at Month 6 (Metabolic syndrome)|Wilcoxon test|||||||<0.001
72599658|NCT00264290|144729493|OTHER|||||||0.007|||||||Fisher Exact|||||||0.007
72599659|NCT01537835|144729518|SUPERIORITY_OR_OTHER|||||||0.17|TWO_SIDED|||||p-value is adjusted for multiple comparisons|Kruskal-Wallis|||||||0.17
72599660|NCT03077607|144729523|EQUIVALENCE|Sample size of 15 participants was selected based on the estimated within participant % coefficient of variation (CV) of 42% and precision/half width of 90% CI for Test Reference comparison on log scale of 0.259.|Geometric LS Mean Ratio|139.92|||||TWO_SIDED|90.0|113.26|172.87||||||Confidence interval (CI): 90 percent (%) CI on geometric least squares (LS) mean ratio (Test/Reference), test is talazoparib in combination with itraconazole and reference is talazoparib alone. Statistical data was calculated by using analysis of variance (ANOVA)||172.87|113.26|
72599661|NCT03077607|144729524|EQUIVALENCE|Sample size of 15 participants was selected based on the estimated within participant %CV of 42% and precision/half width of 90% CI for Test Reference comparison on log scale of 0.259.|Geometric LS Mean Ratio|150.71|||||TWO_SIDED|90.0|136.47|166.43||||||CI: 90% CI on geometric LS mean ratio (Test/Reference), test is talazoparib in combination with itraconazole and reference is talazoparib alone. Statistical data was calculated by using ANOVA.||166.43|136.47|
72415865|NCT04009291|144342680|SUPERIORITY||||||=|0.1281|||||||t-test, 2 sided|||Fisher's exact test is used to compare differences in the proportion of subjects meeting the composite primary endpoint in the TransCon PTH versus pooled placebo group||||= 0.1281
72415866|NCT04009291|144342680|SUPERIORITY||||||>|0.9999|||||||t-test, 2 sided|||Fisher's exact test is used to compare differences in the proportion of subjects meeting the composite primary endpoint in the TransCon PTH versus pooled placebo group||||> 0.9999
72599662|NCT03077607|144729525|EQUIVALENCE|Sample size of 15 participants was selected based on the estimated within participant %CV of 42% and precision/half width of 90% CI for Test Reference comparison on log scale of 0.259.|Geometric LS Mean Ratio|156.24|||||TWO_SIDED|90.0|137.58|177.42||||||CI: 90% CI on geometric LS mean ratio (Test/Reference), test is talazoparib in combination with itraconazole and reference is talazoparib alone. Statistical data was calculated by using ANOVA.||177.42|137.58|
72415867|NCT04009291|144342680|SUPERIORITY||||||=|0.0604|||||||t-test, 2 sided|||Fisher's exact test is used to compare differences in the proportion of subjects meeting the composite primary endpoint in the TransCon PTH versus pooled placebo group||||= 0.0604
72415868|NCT06242444|144342703|SUPERIORITY||Adjusted Mean Difference|8.35|STANDARD_ERROR_OF_MEAN|2.465||0.0012|TWO_SIDED|95.0|3.42|13.28|||Mixed Models Analysis||Adjusted mean difference was calculated as Test Dentifrice minus Placebo Control Dentifrice.|||13.28|3.42|0.0012
72415869|NCT06242444|144342704|SUPERIORITY||Adjusted Mean Difference|37.33|STANDARD_ERROR_OF_MEAN|3.217|<|0.0001|TWO_SIDED|95.0|30.9|43.76|||Mixed Models Analysis||Adjusted mean difference was calculated as Test Dentifrice minus Placebo Control Dentifrice.|||43.76|30.90|<.0001
72599663|NCT03077607|144729526|EQUIVALENCE|Sample size of 15 participants was selected based on the estimated within participant %CV of 42% and precision/half width of 90% CI for Test Reference comparison on log scale of 0.259.|Geometric LS Mean Ratio|136.62|||||TWO_SIDED|90.0|103.2|180.87||||||CI: 90% CI on geometric LS mean ratio (Test/Reference), test is talazoparib in combination with rifampin and reference is talazoparib alone. Statistical data was calculated by using ANOVA.||180.87|103.20|
72599664|NCT03077607|144729527|EQUIVALENCE|Sample size of 15 participants was selected based on the estimated within participant %CV of 42% and precision/half width of 90% CI for Test Reference comparison on log scale of 0.259.|Geometric LS Mean Ratio|105.37|||||TWO_SIDED|90.0|98.04|113.24||||||CI: 90% CI on geometric LS mean ratio (Test/Reference), test is talazoparib in Combination with rifampin and reference is talazoparib alone. Statistical data was calculated by using ANOVA.||113.24|98.04|
72599665|NCT03077607|144729528|EQUIVALENCE|Sample size of 15 participants was selected based on the estimated within participant %CV of 42% and precision/half width of 90% CI for Test Reference comparison on log scale of 0.259.|Geometric LS Mean Ratio|102.04|||||TWO_SIDED|90.0|94.02|110.74||||||CI: 90% CI on geometric LS mean ratio (Test/Reference), test is talazoparib in Combination with rifampin and reference is talazoparib alone. Statistical data was calculated by using ANOVA.||110.74|94.02|
72599666|NCT02087943|144729565|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-15.01||||0.1308|TWO_SIDED|95.0|-34.52|4.5||Based on an analysis of covariance model with the percentage change from baseline as the response variable and the treatment group and Baseline EASI score stratification (≤ 20, \> 20) as factors.|ANCOVA|||||4.50|-34.52|0.1308
72599667|NCT02087943|144729565|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-20.6||||0.0347|TWO_SIDED|95.0|-39.7|-1.5||Based on an analysis of covariance model with the percentage change from Baseline as the response variable and the treatment group and Baseline EASI score stratification (≤ 20, \> 20) as factors.|ANCOVA|||||-1.50|-39.70|0.0347
72599668|NCT02087943|144729566|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference in Proportion|-2.7||||0.4938|TWO_SIDED|95.0|-10.2|4.8||Adjusted treatment differences in proportions using the weighted average of the treatment differences across the stratum of baseline EASI score stratification (≤ 20, \> 20) with, Cochran-Mantel-Haenszel (CMH) weights.|Cochran-Mantel-Haenszel||2-sided 95% Confidence Intervals (CI) is based on a normal approximation to the weighted average.|||4.8|-10.2|0.4938
72599669|NCT02087943|144729566|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference in Proportion|8.0||||0.1368|TWO_SIDED|95.0|-2.3|18.2||Adjusted treatment differences in proportions using the weighted average of the treatment differences across the stratum of baseline EASI score stratification (≤ 20, \> 20) with, CMH weights.|Cochran-Mantel-Haenszel||2-sided 95% Confidence Intervals (CI) is based on a normal approximation to the weighted average.|||18.2|-2.3|0.1368
72599670|NCT02087943|144729567|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference in Proportion|-1.5||||0.8589|TWO_SIDED|95.0|-18.0|14.9|||Cochran-Mantel-Haenszel||Adjusted differences in proportions was the weighted average of the treatment differences across the stratum of baseline EASI score stratification (≤ 20, \> 20) with the CMH weights.|||14.9|-18.0|0.8589
72599671|NCT02087943|144729567|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference in Proportion|9.9||||0.2476|TWO_SIDED|95.0|-6.7|26.6|||Cochran-Mantel-Haenszel||Adjusted differences in proportions was the weighted average of the treatment differences across the stratum of baseline EASI score stratification (≤ 20, \> 20) with the CMH weights.|||26.6|-6.7|0.2476
72599672|NCT02087943|144729568|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-5.17||||0.5286|TWO_SIDED|95.0|-21.34|10.99|||ANCOVA||Based on an analysis of covariance model with the percentage change from baseline as the response variable, treatment group and baseline EASI stratification (≤ 20, \> 20) as factors, and the baseline average weekly pruritus NRS score as a covariate.|||10.99|-21.34|0.5286
72599673|NCT02087943|144729568|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-4.17||||0.6092|TWO_SIDED|95.0|-20.22|11.88|||ANCOVA||Based on an analysis of covariance model with the percentage change from baseline as the response variable, treatment group and baseline EASI stratification (≤ 20, \> 20) as factors, and the baseline average weekly pruritus NRS score as a covariate.|||11.88|-20.22|0.6092
72599674|NCT03836209|144729573|SUPERIORITY||Proportion Difference|-0.071||||0.366|TWO_SIDED|90.0|-0.205|0.062||The threshold for statistical significance was p = 0.10.|Fisher Exact||Treatment Difference = Arm A - Arm B|||0.062|-0.205|0.366
72599675|NCT03836209|144729574|SUPERIORITY||Proportion Difference|-0.059||||0.446|TWO_SIDED|90.0|-0.191|0.073||The threshold for statistical significance was p = 0.10.|Fisher Exact||Treatment Difference = Arm A - Arm B|||0.073|-0.191|0.446
72599676|NCT03836209|144729575|SUPERIORITY||Proportion Difference|0.047||||0.539|TWO_SIDED|90.0|-0.084|0.178||The threshold for statistical significance was p = 0.10.|Fisher Exact||Treatment Difference = Arm A - Arm B|||0.178|-0.084|0.539
72599677|NCT03836209|144729576|SUPERIORITY||Proportion Difference|0.131||||0.042|TWO_SIDED|90.0|0.02|0.242||The threshold for statistical significance was p = 0.10.|Fisher Exact||Treatment Difference = Arm A - Arm B|||0.242|0.020|0.042
72599678|NCT01424241|144729581|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|300.0|||<|0.05|TWO_SIDED||||||t-test, 2 sided|||None available.||||<0.05
72599679|NCT01424241|144729581|SUPERIORITY||Mean Difference (Final Values)|1.6|||<|0.05|TWO_SIDED||||||t-test, 2 sided|||||||<.05
72599680|NCT05259917|144729585|SUPERIORITY||||||<|0.0001|||||||Gehan score transformation test|||"Gehan score transformation test:~KVD900 300 mg vs Placebo"||||<0.0001
72599681|NCT05259917|144729585|SUPERIORITY|||||||0.0013|||||||Gehan score transformation test|||"Gehan score transformation test:~KVD900 600 mg vs Placebo"||||0.0013
72599682|NCT05259917|144729586|SUPERIORITY|||||||0.0036|||||||Gehan score transformation test|||"Gehan score transformation test:~KVD900 300 mg vs Placebo"||||0.0036
72599683|NCT05259917|144729586|SUPERIORITY|||||||0.0032|||||||Gehan score transformation test|||"Gehan score transformation test:~KVD900 600 mg vs Placebo"||||0.0032
72599684|NCT05259917|144729587|SUPERIORITY|||||||0.0022|||||||Gehan score transformation test|||"Gehan score transformation test:~KVD900 300 mg vs Placebo"||||0.0022
72599685|NCT05259917|144729587|SUPERIORITY||||||<|0.0001|||||||Gehan score transformation test|||"Gehan score transformation test:~KVD900 600 mg vs Placebo"||||<0.0001
72599686|NCT00482170|144729588|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority test was performed using the 95 percent (%) confidence interval (CI) of the difference of mean participant satisfaction (alpha = 2.5%). Non-inferiority was demonstrated if the lower limit of the 2-sided CI is greater than -1.|Mean Difference (Final Values)|1.32|STANDARD_ERROR_OF_MEAN|0.23|<|0.001|TWO_SIDED|95.0|0.87|1.77||Statistical testing, one-sided, was done at 2.5% significance level.|ANOVA|||Analysis of variance (ANOVA) using mixed linear model with participant as random effect, treatment group, visit and the interaction between treatment group and visit as fixed factors and with an unstructured correlation was used for the analysis.||1.77|0.87|<0.001
72599687|NCT00482170|144729589|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority test was performed using the 95% CI of the difference of mean participant satisfaction (alpha = 2.5%). Non-inferiority was demonstrated if the lower limit of the 2-sided CI is greater than -1.|Mean Difference (Final Values)|1.41|STANDARD_ERROR_OF_MEAN|0.23|<|0.001|TWO_SIDED|95.0|0.95|1.87||Statistical testing, one-sided, was done at 2.5% significance level.|ANOVA|||ANOVA using a mixed linear model with participant as random effect, treatment group, visit and the interaction between treatment group and visit as fixed factors and with an unstructured correlation was used for the analysis.||1.87|0.95|<0.001
72599688|NCT00482170|144729590|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|16.12||||0.008|TWO_SIDED|95.0|2.05|126.9||Statistical testing, 2-sided, was done at 5% significance level.|Generalized estimating equations|||Baseline- after the training: Generalized Estimating Equations (GEE) model, using a logit link, a binomial distribution and an auto-regressive correlation structure, with treatment group, visit and the interaction between treatment group and visit as fixed factors was used for the analysis.||126.9|2.05|0.008
72599689|NCT00482170|144729590|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|11.25||||0.002|TWO_SIDED|95.0|2.44|51.83||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 4: GEE model, using a logit link, a binomial distribution and an auto-regressive correlation structure, with treatment group, visit and the interaction between treatment group and visit as fixed factors was used for the analysis.||51.83|2.44|0.002
72599690|NCT00482170|144729590|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|7.88||||0.001|TWO_SIDED|95.0|2.26|27.44||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 12: GEE model, using a logit link, a binomial distribution and an auto-regressive correlation structure, with treatment group, visit and the interaction between treatment group and visit as fixed factors was used for the analysis.||27.44|2.26|0.001
72599691|NCT00482170|144729590|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|8.73|||<|0.001|TWO_SIDED|95.0|2.59|29.47||Statistical testing, 2-sided, was done at 5% significance level.|Regression, Logistic|||Last observation: Logistic regression was used for the analysis.||29.47|2.59|<0.001
72599692|NCT00482170|144729591|SUPERIORITY_OR_OTHER||Regression coefficient|0.17||||0.045|TWO_SIDED|95.0|0.0|0.34||Statistical testing, 2-sided, was done at 5% significance level.|Regression, Linear|||Statistical analysis was carried out between all categories, by 10 unit increment. Univariate model in which all continuous variables were considered continuous and mean centered was used.||0.34|0.00|0.045
72599693|NCT00482170|144729592|SUPERIORITY_OR_OTHER||Regression coefficient|-0.09||||0.707|TWO_SIDED|95.0|-0.58|0.39||Statistical testing, 2-sided, was done at 5% significance level.|Regression, Linear|||Statistical analysis was carried out between categories, female and male (reference).||0.39|-0.58|0.707
72599694|NCT00482170|144729593|SUPERIORITY_OR_OTHER||Regression coefficient|-0.38||||0.195|TWO_SIDED|95.0|-0.89|0.14||Statistical testing, 2-sided, was done at 5% significance level.|Regression, Linear|||Statistical analysis was carried out between categories, high school or baccalaureate level and reading or writing capacity (reference).||0.14|-0.89|0.195
72599695|NCT00482170|144729593|SUPERIORITY_OR_OTHER||Regression coefficient|-0.55||||0.195|TWO_SIDED|95.0|-1.21|0.11||Statistical testing, 2-sided, was done at 5% significance level.|Regression, Linear|||Statistical analysis was carried out between categories, university level and reading or writing capacity (reference).||0.11|-1.21|0.195
72599696|NCT00482170|144729594|SUPERIORITY_OR_OTHER||Regression coefficient|-0.09||||0.493|TWO_SIDED|95.0|-0.36|0.17||Statistical testing, 2-sided, was done at 5% significance level.|Regression, Linear|||Statistical analysis was carried out between categories, HAD-A: =\< 4, HAD-A: \> 4 to 7, HAD-A: \> 7 to 10 and HAD-A: \> 10; by 5 unit increment. Univariate model in which all continuous variables were considered continuous and mean centered was used.||0.17|-0.36|0.493
72599697|NCT00482170|144729594|SUPERIORITY_OR_OTHER||Regression coefficient|-0.16||||0.287|TWO_SIDED|95.0|-0.46|0.14||Statistical testing, 2-sided, was done at 5% significance level.|Regression, Linear|||Statistical analysis was carried out between categories, HAD-D: =\< 3, HAD-D: \> 3 to 5, HAD-D: \> 5 to 8 and HAD-A: \> 8; by 5 unit increment. Univariate model in which all continuous variables were considered continuous and mean centered was used.||0.14|-0.46|0.287
72599698|NCT00482170|144729595|SUPERIORITY_OR_OTHER||Regression coefficient|0.13||||0.123|TWO_SIDED|95.0|-0.04|0.3||Statistical testing, 2-sided, was done at 5% significance level.|Regression, Linear|||Statistical analysis was carried out between all categories, by 10 unit increment. Univariate model in which all continuous variables were considered continuous and mean centered was used.||0.30|-0.04|0.123
72599699|NCT00482170|144729596|SUPERIORITY_OR_OTHER||Regression coefficient|-0.24||||0.359|TWO_SIDED|95.0|-0.76|0.28||Statistical testing, 2-sided, was done at 5% significance level.|Regression, Linear|||Statistical analysis was carried out between categories, yes and no (reference).||0.28|-0.76|0.359
72599700|NCT00482170|144729597|SUPERIORITY_OR_OTHER||Regression coefficient|0.02||||0.693|TWO_SIDED|95.0|-0.08|0.12|||Regression, Linear|||Statistical analysis was carried out between all categories, by 5 unit increment. Univariate model in which all continuous variables were considered continuous and mean centered was used.||0.12|-0.08|0.693
72415870|NCT06242444|144342705|SUPERIORITY||Adjusted Mean Difference|3.95|STANDARD_ERROR_OF_MEAN|2.462||0.1138|TWO_SIDED|95.0|-0.97|8.87|||Mixed Models Analysis||Adjusted mean difference was calculated as Test Dentifrice minus Reference Dentifrice.|||8.87|-0.97|0.1138
72415871|NCT06242444|144342707|SUPERIORITY||Adjusted Mean Difference|2.22|STANDARD_ERROR_OF_MEAN|3.213||0.493|TWO_SIDED|95.0|-4.21|8.64|||Mixed Models Analysis||Adjusted mean difference was calculated as Test Dentifrice minus Reference Dentifrice.|||8.64|-4.21|0.4930
72415872|NCT06242444|144342711|SUPERIORITY||Adjusted Mean Difference|4.4|STANDARD_ERROR_OF_MEAN|2.462||0.0789|TWO_SIDED|95.0|-0.52|9.32|||Mixed Models Analysis||Adjusted mean difference was calculated as Reference Dentifrice minus Placebo Control Dentifrice.|At 4 hours of intra-oral exposure||9.32|-0.52|0.0789
72415873|NCT06242444|144342711|SUPERIORITY||Adjusted Mean Difference|3.0|STANDARD_ERROR_OF_MEAN|2.408||0.2178|TWO_SIDED|95.0|-1.82|7.81|||Mixed Models Analysis||Adjusted mean difference was calculated as Reference Dentifrice minus Placebo Control Dentifrice.|At 12 hours of intra-oral exposure||7.81|-1.82|0.2178
72415874|NCT06242444|144342712|SUPERIORITY||Adjusted Mean Difference|35.12|STANDARD_ERROR_OF_MEAN|3.213|<|0.0001|TWO_SIDED|95.0|28.69|41.54|||Mixed Models Analysis||Adjusted mean difference was calculated as Reference Dentifrice minus Placebo Control Dentifrice.|At 4 hours of intra-oral exposure||41.54|28.69|<.0001
72415875|NCT06242444|144342712|SUPERIORITY||Adjusted Mean Difference|27.18|STANDARD_ERROR_OF_MEAN|3.018|<|0.0001|TWO_SIDED|95.0|21.14|33.21|||Mixed Models Analysis||Adjusted mean difference was calculated as Reference Dentifrice minus Placebo Control Dentifrice.|At 12 hours of intra-oral exposure||33.21|21.14|<.0001
72599701|NCT00482170|144729598|SUPERIORITY_OR_OTHER||Regression coefficient|0.22||||0.17|TWO_SIDED|95.0|-0.09|0.53||Statistical testing, 2-sided, was done at 5% significance level.|Regression, Linear|||Statistical analysis was carried out between all categories, by 1 unit increment. Univariate model in which all continuous variables were considered continuous and mean centered was used.||0.53|-0.09|0.170
72599702|NCT00482170|144729599|SUPERIORITY_OR_OTHER||Regression coefficient|0.02||||0.211|TWO_SIDED|95.0|-0.01|0.04||Statistical testing, 2-sided, was done at 5% significance level.|Regression, Linear|||Statistical analysis was carried out between all categories, by 1 unit increment. Univariate model in which all continuous variables were considered continuous and mean centered was used.||0.04|-0.01|0.211
72599703|NCT00482170|144729600|SUPERIORITY_OR_OTHER||Regression coefficient|0.09||||0.045|TWO_SIDED|95.0|0.0|0.18||Statistical testing, 2-sided, was done at 5% significance level.|Regression, Linear|||Statistical analysis was carried out between all categories, by 10 unit increment. Univariate model in which all continuous variables were considered continuous and mean centered was used.||0.18|0.00|0.045
72599704|NCT00482170|144729601|SUPERIORITY_OR_OTHER||Regression coefficient|-0.01||||0.913|TWO_SIDED|95.0|-0.12|0.11||Statistical testing, 2-sided, was done at 5% significance level.|Regression, Linear|||Statistical analysis was carried out between all categories, by 10 unit increment. Univariate model in which all continuous variables were considered continuous and mean centered was used.||0.11|-0.12|0.913
72599705|NCT00482170|144729602|SUPERIORITY_OR_OTHER||Regression coefficient|0.0||||0.968|TWO_SIDED|95.0|-0.17|0.17||Statistical testing, 2-sided, was done at 5% significance level.|Regression, Linear|||Statistical analysis was carried out between all categories, by 5 unit increment. Univariate model in which all continuous variables were considered continuous and mean centered was used.||0.17|-0.17|0.968
72599706|NCT00482170|144729603|SUPERIORITY_OR_OTHER||Regression coefficient|-0.15||||0.531|TWO_SIDED|95.0|-0.61|0.32||Statistical testing, 2-sided, was done at 5% significance level.|Regression, Linear|||Statistical analysis was carried out between categories, current tobacco usage: yes and current tobacco usage: no (reference).||0.32|-0.61|0.531
72599707|NCT00482170|144729603|SUPERIORITY_OR_OTHER||Regression coefficient|0.44||||0.061|TWO_SIDED|95.0|-0.02|0.9||Statistical testing, 2-sided, was done at 5% significance level.|Regression, Linear|||Statistical analysis was carried out between categories, current alcohol usage: yes and current alcohol usage: no (reference).||0.90|-0.02|0.061
72415876|NCT06242444|144342713|SUPERIORITY||Geometric Mean Ratio|1.73|||<|0.0001|TWO_SIDED|95.0|1.53|1.97|||Mixed Models Analysis|||At 4 hours of intra-oral exposure||1.97|1.53|<.0001
72599708|NCT00482170|144729604|SUPERIORITY_OR_OTHER||Regression coefficient|-0.73||||0.759|TWO_SIDED|95.0|-5.37|3.92||Statistical testing, 2-sided, was done at 5% significance level.|Regression, Linear|||Statistical analysis was carried out between categories, yes and no (reference).||3.92|-5.37|0.759
72599709|NCT00482170|144729605|SUPERIORITY_OR_OTHER||Regression coefficient|0.09||||0.713|TWO_SIDED|95.0|-0.37|0.55||Statistical testing, 2-sided, was done at 5% significance level.|Regression, Linear|||Statistical analysis was carried out between categories, yes and no (reference).||0.55|-0.37|0.713
72599710|NCT00482170|144729606|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.39|||<|0.001|TWO_SIDED|95.0|1.63|3.49||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Baseline- after the training: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||3.49|1.63|<0.001
72599711|NCT00482170|144729606|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.43|||<|0.001|TWO_SIDED|95.0|1.61|3.67||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 4:A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||3.67|1.61|<0.001
72599712|NCT00482170|144729606|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.74|||<|0.001|TWO_SIDED|95.0|1.78|4.21||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 12: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||4.21|1.78|<0.001
72415877|NCT06242444|144342713|SUPERIORITY||Geometric Mean Ratio|1.59|||<|0.0001|TWO_SIDED|95.0|1.42|1.78|||Mixed Models Analysis|||At 12 hours of intra-oral exposure||1.78|1.42|<.0001
72415878|NCT06242444|144342714|SUPERIORITY||Adjusted Mean Difference|0.307|STANDARD_ERROR_OF_MEAN|0.0277|<|0.0001|TWO_SIDED|95.0|0.252|0.362|||Mixed Models Analysis||Adjusted mean difference was calculated as Reference Dentifrice minus Placebo Control Dentifrice.|At 4 hours of intra-oral exposure||0.362|0.252|<.0001
72415879|NCT06242444|144342714|SUPERIORITY||Adjusted Mean Difference|0.242|STANDARD_ERROR_OF_MEAN|0.0257|<|0.0001|TWO_SIDED|95.0|0.19|0.293|||Mixed Models Analysis||Adjusted mean difference was calculated as Reference Dentifrice minus Placebo Control Dentifrice.|At 12 hours of intra-oral exposure||0.293|0.190|<.0001
72415880|NCT02979262|144342715|SUPERIORITY||||||>|0.1|||||||Repeated Measures GLM|Time 2 at 16 weeks||||||>.10
72415881|NCT02979262|144342716|SUPERIORITY||||||<|0.01|||||||GEE|||||||<.01
72415882|NCT02979262|144342717|SUPERIORITY||||||>|0.1|||||||GEE|||||||>.10
72415883|NCT02979262|144342718|SUPERIORITY||||||>|0.1|||||||GEE|||||||>.10
72415884|NCT02979262|144342719|SUPERIORITY||||||>|0.1|||||||GEE|||||||>.10
72599713|NCT00482170|144729606|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.51|||<|0.001|TWO_SIDED|95.0|1.66|3.8||Statistical testing, 2-sided, was done at 5% significance level.|Regression, Logistic|||Last observation: Logistic regression was used to analyze individual concepts and questions measuring participant perception.||3.80|1.66|<0.001
72599714|NCT00482170|144729607|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.88||||0.004|TWO_SIDED|95.0|1.22|2.89||Statistical testing, 2-sided, was done at 5% significance level.|Generalized estimating equations|||Baseline- after the training: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||2.89|1.22|0.004
72599715|NCT00482170|144729607|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.73||||0.017|TWO_SIDED|95.0|1.1|2.72||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 4: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||2.72|1.10|0.017
72415885|NCT02979262|144342720|SUPERIORITY||||||<|0.01|||||||GEE|||||||<.01
72415886|NCT02959996|144342770|SUPERIORITY|||||||0.72|||||||Wilcoxon (Mann-Whitney)|||||||0.72
72599716|NCT00482170|144729607|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.34|||<|0.001|TWO_SIDED|95.0|1.47|3.73||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 12: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||3.73|1.47|<0.001
72599717|NCT00482170|144729607|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.06||||0.001|TWO_SIDED|95.0|1.32|3.21||Statistical testing, 2-sided, was done at 5% significance level.|Regression, Logistic|||Last observation: Logistic regression was used to analyze individual concepts and questions measuring participant perception.||3.21|1.32|0.001
72599718|NCT00482170|144729608|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.68||||0.025|TWO_SIDED|95.0|1.07|2.64||Statistical testing, 2-sided, was done at 5% significance level.|Generalized estimating equations|||Baseline- after the training: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||2.64|1.07|0.025
72599719|NCT00482170|144729608|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.02||||0.936|TWO_SIDED|95.0|0.63|1.64||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 4: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||1.64|0.63|0.936
72599720|NCT00482170|144729608|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.22||||0.42|TWO_SIDED|95.0|0.75|1.99||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 12: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||1.99|0.75|0.420
72599721|NCT00482170|144729608|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.12||||0.625|TWO_SIDED|95.0|0.71|1.79||Statistical testing, 2-sided, was done at 5% significance level.|Regression, Logistic|||Last observation: Logistic regression was used to analyze individual concepts and questions measuring participant perception.||1.79|0.71|0.625
72599722|NCT00482170|144729609|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.3||||0.21|TWO_SIDED|95.0|0.86|1.94||Statistical testing, 2-sided, was done at 5% significance level.|Generalized estimating equations|||Baseline- after the training: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||1.94|0.86|0.210
72599723|NCT00482170|144729609|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.31||||0.227|TWO_SIDED|95.0|0.85|2.03||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 4: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||2.03|0.85|0.227
72599724|NCT00482170|144729609|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.33||||0.22|TWO_SIDED|95.0|0.84|2.08||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 12: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||2.08|0.84|0.220
72599725|NCT00482170|144729609|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.29||||0.249|TWO_SIDED|95.0|0.84|2.0||Statistical testing, 2-sided, was done at 5% significance level.|Regression, Logistic|||Last observation: Logistic regression was used to analyze individual concepts and questions measuring participant perception.||2.00|0.84|0.249
72599726|NCT00482170|144729610|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.18|||<|0.001|TWO_SIDED|95.0|1.48|3.21||Statistical testing, 2-sided, was done at 5% significance level.|Generalized estimating equations|||Baseline- after the training: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||3.21|1.48|<0.001
72599727|NCT00482170|144729610|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.42|||<|0.001|TWO_SIDED|95.0|1.62|3.62||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 4: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||3.62|1.62|<0.001
72599728|NCT00482170|144729610|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.35|||<|0.001|TWO_SIDED|95.0|1.58|3.51||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 12: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||3.51|1.58|<0.001
72599729|NCT00482170|144729610|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.42|||<|0.001|TWO_SIDED|95.0|1.64|3.59||Statistical testing, 2-sided, was done at 5% significance level.|Regression, Logistic|||Last observation: Logistic regression was used to analyze individual concepts and questions measuring participant perception.||3.59|1.64|<0.001
72599730|NCT00482170|144729611|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.34|||<|0.001|TWO_SIDED|95.0|1.5|3.65||Statistical testing, 2-sided, was done at 5% significance level.|Generalized estimating equations|||Baseline- after the training: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||3.65|1.50|<0.001
72599731|NCT00482170|144729611|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.96|||<|0.001|TWO_SIDED|95.0|1.83|4.77||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 4: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||4.77|1.83|<0.001
72599732|NCT00482170|144729611|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.58|||<|0.001|TWO_SIDED|95.0|1.62|4.12||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 12: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||4.12|1.62|<0.001
72599733|NCT00482170|144729611|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.45|||<|0.001|TWO_SIDED|95.0|1.55|3.86||Statistical testing, 2-sided, was done at 5% significance level.|Regression, Logistic|||Last observation: Logistic regression was used to analyze individual concepts and questions measuring participant perception.||3.86|1.55|<0.001
72599734|NCT00482170|144729612|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.09||||0.681|TWO_SIDED|95.0|0.73|1.62||Statistical testing, 2-sided, was done at 5% significance level.|Generalized estimating equations|||Baseline- after the training: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||1.62|0.73|0.681
72415887|NCT02959996|144342771|SUPERIORITY|||||||0.14|||||||Wilcoxon (Mann-Whitney)|||||||.14
72599735|NCT00482170|144729612|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.01||||0.947|TWO_SIDED|95.0|0.67|1.54||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 4: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||1.54|0.67|0.947
72599736|NCT00482170|144729612|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.9||||0.604|TWO_SIDED|95.0|0.59|1.36||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 12: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||1.36|0.59|0.604
72599737|NCT00482170|144729612|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.85||||0.43|TWO_SIDED|95.0|0.57|1.27||Statistical testing, 2-sided, was done at 5% significance level.|Regression, Logistic|||Last observation: Logistic regression was used to analyze individual concepts and questions measuring participant perception.||1.27|0.57|0.430
72415888|NCT02959996|144342772|SUPERIORITY|||||||0.54|||||||Wilcoxon (Mann-Whitney)|||||||0.54
72599738|NCT00482170|144729613|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.7||||0.072|TWO_SIDED|95.0|0.48|1.03||Statistical testing, 2-sided, was done at 5% significance level.|Generalized estimating equations|||Baseline- after the training: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||1.03|0.48|0.072
72415889|NCT02962908|144342779|OTHER|Inequality test.||||||0.45|||||||Wilcoxon (Mann-Whitney)|||Comparison of the difference in median fold increase in number of CD4+ T cells positive for IFN-gamma from day 0 and to 42.||||0.45
72599739|NCT00482170|144729613|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.32||||0.205|TWO_SIDED|95.0|0.86|2.03||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 4: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||2.03|0.86|0.205
72599740|NCT00482170|144729613|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.18||||0.434|TWO_SIDED|95.0|0.78|1.78||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 12: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||1.78|0.78|0.434
72599741|NCT00482170|144729613|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.04||||0.857|TWO_SIDED|95.0|0.69|1.55||Statistical testing, 2-sided, was done at 5% significance level.|Regression, Logistic|||Last observation: Logistic regression was used to analyze individual concepts and questions measuring participant perception.||1.55|0.69|0.857
72599742|NCT00482170|144729614|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.04||||0.837|TWO_SIDED|95.0|0.7|1.56||Statistical testing, 2-sided, was done at 5% significance level.|Generalized estimating equations|||Baseline- after the training: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||1.56|0.70|0.837
72599743|NCT00482170|144729614|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.37||||0.172|TWO_SIDED|95.0|0.87|2.15||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 4: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||2.15|0.87|0.172
72599744|NCT00482170|144729614|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.45||||0.096|TWO_SIDED|95.0|0.94|2.24||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 12: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||2.24|0.94|0.096
72599745|NCT00482170|144729614|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.36||||0.164|TWO_SIDED|95.0|0.88|2.08||Statistical testing, 2-sided, was done at 5% significance level.|Regression, Logistic|||Last observation: Logistic regression was used to analyze individual concepts and questions measuring participant perception.||2.08|0.88|0.164
72415890|NCT02962908|144342779|OTHER|inequality test|||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Comparison of the difference in median fold increase in number of CD4+ T cells positive for IFN-gamma from day 0 and to 42.||||<0.001
72415891|NCT02962908|144342779|OTHER|inequality test||||||0.88|||||||Wilcoxon (Mann-Whitney)|||Comparison of the difference in median fold increase in number of CD4+ T cells positive for TNF-alpha from day 0 to day 42.||||0.88
72415892|NCT02962908|144342779|OTHER|inequality test|||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Comparison of the difference in median fold increase in number of CD4+ T cells positive for TNF-alpha from day 0 to day 42.||||<0.001
72415893|NCT02962908|144342779|OTHER|inequality test||||||0.21|||||||Wilcoxon (Mann-Whitney)|||Comparison of the difference in median fold increase in number of CD4+ T cells positive for IL-2 from day 0 to day 42.||||0.21
72599746|NCT00482170|144729615|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.18||||0.356|TWO_SIDED|95.0|0.83|1.69||Statistical testing, 2-sided, was done at 5% significance level.|Generalized estimating equations|||Baseline- after the training: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||1.69|0.83|0.356
72599747|NCT00482170|144729615|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.07||||0.737|TWO_SIDED|95.0|0.73|1.56||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 4: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||1.56|0.73|0.737
72415894|NCT02962908|144342779|OTHER|inequality test|||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Comparison of the difference in median fold increase in number of CD4+ T cells positive for IL-2 from day 0 to day 42.||||<0.001
72415895|NCT02962908|144342779|OTHER|inequality test||||||0.77|||||||Wilcoxon (Mann-Whitney)|||Comparison of the difference in median fold increase in number of CD4+ T cells positive for CD107a from day 0 to day 42.||||0.77
72415896|NCT02962908|144342779|OTHER|inequality test||||||0.004|||||||Wilcoxon (Mann-Whitney)|||Comparison of the difference in median fold increase in number of CD4+ T cells positive for CD107a from day 0 to day 42.||||0.004
72415897|NCT02962908|144342779|OTHER|inequality test||||||0.08|||||||Wilcoxon (Mann-Whitney)|||Comparison of the difference in median fold increase in number of CD8+ T cells positive for IFN-gamma from day 0 to day 42.||||0.08
72599748|NCT00482170|144729615|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.31||||0.156|TWO_SIDED|95.0|0.9|1.91||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 12: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||1.91|0.90|0.156
72599749|NCT00482170|144729615|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.22||||0.29|TWO_SIDED|95.0|0.85|1.76||Statistical testing, 2-sided, was done at 5% significance level.|Regression, Logistic|||Last observation: Logistic regression was used to analyze individual concepts and questions measuring participant perception.||1.76|0.85|0.290
72599750|NCT00482170|144729616|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.72||||0.065|TWO_SIDED|95.0|0.5|1.02||Statistical testing, 2-sided, was done at 5% significance level.|Generalized estimating equations|||Baseline- after the training: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||1.02|0.50|0.065
72599751|NCT00482170|144729616|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.73||||0.1|TWO_SIDED|95.0|0.5|1.06||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 4: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||1.06|0.50|0.100
72599752|NCT00482170|144729616|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.81||||0.298|TWO_SIDED|95.0|0.54|1.21||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 12: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||1.21|0.54|0.298
72599753|NCT00482170|144729616|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.75||||0.148|TWO_SIDED|95.0|0.51|1.11||Statistical testing, 2-sided, was done at 5% significance level.|Regression, Logistic|||Last observation: Logistic regression was used to analyze individual concepts and questions measuring participant perception.||1.11|0.51|0.148
72599754|NCT00482170|144729617|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.38||||0.098|TWO_SIDED|95.0|0.94|2.03||Statistical testing, 2-sided, was done at 5% significance level.|Generalized estimating equations|||Baseline- after the training: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||2.03|0.94|0.098
72599755|NCT00482170|144729617|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.24||||0.311|TWO_SIDED|95.0|0.82|1.87||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 4: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||1.87|0.82|0.311
72599756|NCT00482170|144729617|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.21||||0.376|TWO_SIDED|95.0|0.79|1.85||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 12: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||1.85|0.79|0.376
72599757|NCT00482170|144729617|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.24||||0.299|TWO_SIDED|95.0|0.83|1.86||Statistical testing, 2-sided, was done at 5% significance level.|Regression, Logistic|||Last observation: Logistic regression was used to analyze individual concepts and questions measuring participant perception.||1.86|0.83|0.299
72415898|NCT02962908|144342779|OTHER|inequality test||||||0.38|||||||Wilcoxon (Mann-Whitney)|||Comparison of the difference in median fold increase in number of CD8+ T cells positive for IFN-gamma from day 0 to day 42.||||0.38
72415899|NCT02962908|144342779|OTHER|inequality test||||||0.49|||||||Wilcoxon (Mann-Whitney)|||Comparison of the difference in median fold increase in number of CD8+ T cells positive for TNF-alpha from day 0 to day 42.||||0.49
72415900|NCT02962908|144342779|OTHER|inequality test||||||0.156|||||||Wilcoxon (Mann-Whitney)|||Comparison of the difference in median fold increase in number of CD8+ T cells positive for TNF-alpha from day 0 to day 42.||||0.156
72599758|NCT00482170|144729618|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.88||||0.494|TWO_SIDED|95.0|0.6|1.28||Statistical testing, 2-sided, was done at 5% significance level.|Generalized estimating equations|||Baseline- after the training: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||1.28|0.60|0.494
72599759|NCT00482170|144729618|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.65||||0.036|TWO_SIDED|95.0|0.44|0.97||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 4: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||0.97|0.44|0.036
72599760|NCT00482170|144729618|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.69||||0.079|TWO_SIDED|95.0|0.45|1.04||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 12: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||1.04|0.45|0.079
72599761|NCT00482170|144729618|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.68||||0.063|TWO_SIDED|95.0|0.46|1.02||Statistical testing, 2-sided, was done at 5% significance level.|Regression, Logistic|||Last observation: Logistic regression was used to analyze individual concepts and questions measuring participant perception.||1.02|0.46|0.063
72599762|NCT00482170|144729619|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.91||||0.628|TWO_SIDED|95.0|0.62|1.33||Statistical testing, 2-sided, was done at 5% significance level.|Generalized estimating equations|||Baseline- after the training: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||1.33|0.62|0.628
72599763|NCT00482170|144729619|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.77||||0.203|TWO_SIDED|95.0|0.51|1.15||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 4: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||1.15|0.51|0.203
72599764|NCT00482170|144729619|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.77||||0.222|TWO_SIDED|95.0|0.51|1.17||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 12: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||1.17|0.51|0.222
72599765|NCT00482170|144729619|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.79||||0.263|TWO_SIDED|95.0|0.53|1.19||Statistical testing, 2-sided, was done at 5% significance level.|Regression, Logistic|||Last observation: Logistic regression was used to analyze individual concepts and questions measuring participant perception.||1.19|0.53|0.263
72599766|NCT00482170|144729620|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.02||||0.914|TWO_SIDED|95.0|0.7|1.5||Statistical testing, 2-sided, was done at 5% significance level.|Generalized estimating equations|||Baseline- after the training: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||1.50|0.70|0.914
72599767|NCT00482170|144729620|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.05||||0.827|TWO_SIDED|95.0|0.7|1.57||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 4: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||1.57|0.70|0.827
72599768|NCT00482170|144729620|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.93||||0.712|TWO_SIDED|95.0|0.61|1.4||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 12: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||1.40|0.61|0.712
72415901|NCT02962908|144342779|OTHER|inequality test||||||0.125|||||||Wilcoxon (Mann-Whitney)|||Comparison of the difference in median fold increase in number of CD8+ T cells positive for IL-2 from day 0 to day 42.||||0.125
72415902|NCT02962908|144342779|OTHER|inequality test||||||0.89|||||||Wilcoxon (Mann-Whitney)|||||||0.89
72599769|NCT00482170|144729620|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.93||||0.733|TWO_SIDED|95.0|0.62|1.39||Statistical testing, 2-sided, was done at 5% significance level.|Regression, Logistic|||Last observation: Logistic regression was used to analyze individual concepts and questions measuring participant perception.||1.39|0.62|0.733
72599770|NCT00482170|144729621|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.36||||0.09|TWO_SIDED|95.0|0.95|1.95||Statistical testing, 2-sided, was done at 5% significance level.|Generalized estimating equations|||Baseline- after the training: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||1.95|0.95|0.090
72599771|NCT00482170|144729621|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.31||||0.154|TWO_SIDED|95.0|0.9|1.91||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 4: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||1.91|0.90|0.154
72599772|NCT00482170|144729621|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.51||||0.037|TWO_SIDED|95.0|1.02|2.22||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 12: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||2.22|1.02|0.037
72599773|NCT00482170|144729621|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.53||||0.028|TWO_SIDED|95.0|1.05|2.24||Statistical testing, 2-sided, was done at 5% significance level.|Regression, Logistic|||Last observation: Logistic regression was used to analyze individual concepts and questions measuring participant perception.||2.24|1.05|0.028
72415903|NCT02962908|144342779|OTHER|inequality test||||||0.72|||||||Wilcoxon (Mann-Whitney)|||Comparison of the difference in median fold increase in number of CD8+ T cells positive for CD107a from day 0 to day 42.||||0.72
72415904|NCT02962908|144342779|OTHER|inequality test||||||0.34|||||||Wilcoxon (Mann-Whitney)|||Comparison of the difference in median fold increase in number of CD8+ T cells positive for CD107a from day 0 to day 42.||||0.34
72415905|NCT02962908|144342780|OTHER|inequality test||||||0.62|||||||Wilcoxon (Mann-Whitney)|||Comparison of the difference in median fold increase in number of CD4+ T cells positive for IFN-gamma from day 0 to day 180.||||0.62
72415906|NCT02962908|144342780|OTHER|inequality test||||||0.03|||||||Wilcoxon (Mann-Whitney)|||Comparison of the difference in median fold increase in number of CD4+ T cells positive for IFN-gamma from day 0 to day 180.||||0.030
72599774|NCT00482170|144729622|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.53||||0.022|TWO_SIDED|95.0|1.06|2.21||Statistical testing, 2-sided, was done at 5% significance level.|Generalized estimating equations|||Baseline- after the training: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||2.21|1.06|0.022
72599775|NCT00482170|144729622|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.68||||0.005|TWO_SIDED|95.0|1.17|2.41||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 4: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||2.41|1.17|0.005
72599776|NCT00482170|144729622|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.4||||0.076|TWO_SIDED|95.0|0.97|2.03||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 12: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||2.03|0.97|0.076
72599777|NCT00482170|144729622|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.45||||0.049|TWO_SIDED|95.0|1.0|2.11||Statistical testing, 2-sided, was done at 5% significance level.|Regression, Logistic|||Last observation: Logistic regression was used to analyze individual concepts and questions measuring participant perception.||2.11|1.00|0.049
72599778|NCT00482170|144729623|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.93|||<|0.001|TWO_SIDED|95.0|1.32|2.83||Statistical testing, 2-sided, was done at 5% significance level.|Generalized estimating equations|||Baseline- after the training: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||2.83|1.32|<0.001
72599779|NCT00482170|144729623|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.63|||<|0.001|TWO_SIDED|95.0|1.78|3.87||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 4: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||3.87|1.78|<0.001
72599780|NCT00482170|144729623|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.13|||<|0.001|TWO_SIDED|95.0|1.42|3.19||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 12: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||3.19|1.42|<0.001
72599781|NCT00482170|144729623|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.27|||<|0.001|TWO_SIDED|95.0|1.52|3.39||Statistical testing, 2-sided, was done at 5% significance level.|Regression, Logistic|||Last observation: Logistic regression was used to analyze individual concepts and questions measuring participant perception.||3.39|1.52|<0.001
72599782|NCT00482170|144729624|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.44||||0.057|TWO_SIDED|95.0|0.99|2.11||Statistical testing, 2-sided, was done at 5% significance level.|Generalized estimating equations|||Baseline- after the training: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||2.11|0.99|0.057
72599783|NCT00482170|144729624|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.33||||0.151|TWO_SIDED|95.0|0.9|1.96||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 4: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||1.96|0.90|0.151
72415907|NCT02962908|144342780|OTHER|inequality test||||||0.87|||||||Wilcoxon (Mann-Whitney)|||Comparison of the difference in median fold increase in number of CD4+ T cells positive for TNF-alpha from day 0 to day 180.||||0.87
72415908|NCT02962908|144342780|OTHER|inequality test||||||0.075|||||||Wilcoxon (Mann-Whitney)|||Comparison of the difference in median fold increase in number of CD4+ T cells positive for TNF-alpha from day 0 to day 180.||||0.075
72415909|NCT02962908|144342780|OTHER|inequality test||||||0.076|||||||Wilcoxon (Mann-Whitney)|||Comparison of the difference in median fold increase in number of CD4+ T cells positive for IL-2 from day 0 to day 180.||||0.076
72415910|NCT02962908|144342780|OTHER|inequality test|||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Comparison of the difference in median fold increase in number of CD4+ T cells positive for IL-2 from day 0 to day 180.||||<0.001
72415911|NCT02962908|144342780|OTHER|inequality test||||||0.91|||||||Wilcoxon (Mann-Whitney)|||Comparison of the difference in median fold increase in number of CD4+ T cells positive for CD107a from day 0 to day 180.||||0.91
72599784|NCT00482170|144729624|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.61||||0.024|TWO_SIDED|95.0|1.06|2.44||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 12: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||2.44|1.06|0.024
72599785|NCT00482170|144729624|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.59||||0.025|TWO_SIDED|95.0|1.06|2.39||Statistical testing, 2-sided, was done at 5% significance level.|Regression, Logistic|||Last observation: Logistic regression was used to analyze individual concepts and questions measuring participant perception.||2.39|1.06|0.025
72599786|NCT00482170|144729625|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.34|||<|0.001|TWO_SIDED|95.0|0.24|0.49||Statistical testing, 2-sided, was done at 5% significance level.|Generalized estimating equations|||Baseline- after the training: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||0.49|0.24|<0.001
72599787|NCT00482170|144729625|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.26|||<|0.001|TWO_SIDED|95.0|0.18|0.37||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 4: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||0.37|0.18|<0.001
72599788|NCT00482170|144729625|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.31|||<|0.001|TWO_SIDED|95.0|0.21|0.45||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 12: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||0.45|0.21|<0.001
72599789|NCT00482170|144729625|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.32|||<|0.001|TWO_SIDED|95.0|0.23|0.47||Statistical testing, 2-sided, was done at 5% significance level.|Regression, Logistic|||Last observation: Logistic regression was used to analyze individual concepts and questions measuring participant perception.||0.47|0.23|<0.001
72599790|NCT00482170|144729626|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.38|||<|0.001|TWO_SIDED|95.0|0.27|0.54||Statistical testing, 2-sided, was done at 5% significance level.|Generalized estimating equations|||Baseline- after the training: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||0.54|0.27|<0.001
72599791|NCT00482170|144729626|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.31|||<|0.001|TWO_SIDED|95.0|0.21|0.46||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 4: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||0.46|0.21|<0.001
72599792|NCT00482170|144729626|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.34|||<|0.001|TWO_SIDED|95.0|0.24|0.5||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 12: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||0.50|0.24|<0.001
72599793|NCT00482170|144729626|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.35|||<|0.001|TWO_SIDED|95.0|0.24|0.5||Statistical testing, 2-sided, was done at 5% significance level.|Regression, Logistic|||Last observation: Logistic regression was used to analyze individual concepts and questions measuring participant perception.||0.50|0.24|<0.001
72599794|NCT00482170|144729627|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.33|||<|0.001|TWO_SIDED|95.0|0.24|0.46||Statistical testing, 2-sided, was done at 5% significance level.|Generalized estimating equations|||Baseline- after the training: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||0.46|0.24|<0.001
72415912|NCT02962908|144342780|OTHER|inequality test||||||0.91|||||||Wilcoxon (Mann-Whitney)|||Comparison of the difference in median fold increase in number of CD4+ T cells positive for CD107a from day 0 to day 180.||||0.91
72415913|NCT02962908|144342780|OTHER|inequality test||||||0.55|||||||Wilcoxon (Mann-Whitney)|||Comparison of the difference in median fold increase in number of CD8+ T cells positive for IFN-gamma from day 0 to day 180.||||0.55
72415914|NCT02962908|144342780|OTHER|inequality test||||||0.55|||||||Wilcoxon (Mann-Whitney)|||Comparison of the difference in median fold increase in number of CD8+ T cells positive for IFN-gamma from day 0 to day 180.||||0.55
72415915|NCT02962908|144342780|OTHER|inequality||||||0.91|||||||Wilcoxon (Mann-Whitney)|||Comparison of the difference in median fold increase in number of CD8+ T cells positive for TNF-alpha from day 0 to day 180.||||0.91
72599795|NCT00482170|144729627|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.32|||<|0.001|TWO_SIDED|95.0|0.22|0.46||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 4: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||0.46|0.22|<0.001
72599796|NCT00482170|144729627|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.38|||<|0.001|TWO_SIDED|95.0|0.26|0.56||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 12: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||0.56|0.26|<0.001
72599797|NCT00482170|144729627|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.41|||<|0.001|TWO_SIDED|95.0|0.28|0.58||Statistical testing, 2-sided, was done at 5% significance level.|Regression, Logistic|||Last observation: Logistic regression was used to analyze individual concepts and questions measuring participant perception.||0.58|0.28|<0.001
72599798|NCT00482170|144729628|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.87||||0.47|TWO_SIDED|95.0|0.6|1.26||Statistical testing, 2-sided, was done at 5% significance level.|Generalized estimating equations|||Baseline- after the first injection: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||1.26|0.60|0.470
72415916|NCT02962908|144342780|OTHER|inequality test||||||0.91|||||||Wilcoxon (Mann-Whitney)|||Comparison of the difference in median fold increase in number of CD8+ T cells positive for TNF-alpha from day 0 to day 180.||||0.91
72415917|NCT02962908|144342780|OTHER|inequality test||||||0.21|||||||Wilcoxon (Mann-Whitney)|||Comparison of the difference in median fold increase in number of CD8+ T cells positive for IL2 from day 0 to day 180.||||0.21
72415918|NCT02962908|144342780|OTHER|inequality test||||||0.48|||||||Wilcoxon (Mann-Whitney)|||Comparison of the difference in median fold increase in number of CD8+ T cells positive for IL2 from day 0 to day 180.||||0.48
72599799|NCT00482170|144729628|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.83||||0.325|TWO_SIDED|95.0|0.57|1.2||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 4: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||1.20|0.57|0.325
72415919|NCT02962908|144342780|OTHER|inequality test||||||0.62|||||||Wilcoxon (Mann-Whitney)|||Comparison of the difference in median fold increase in number of CD8+ T cells positive for CD107a from day 0 to day 180.||||0.62
72599800|NCT00482170|144729628|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.79||||0.197|TWO_SIDED|95.0|0.55|1.13||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 12: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||1.13|0.55|0.197
72599801|NCT00482170|144729628|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.8||||0.212|TWO_SIDED|95.0|0.56|1.14||Statistical testing, 2-sided, was done at 5% significance level.|Regression, Logistic|||Last observation: Logistic regression was used to analyze individual concepts and questions measuring participant perception.||1.14|0.56|0.212
72599802|NCT00482170|144729629|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.23|STANDARD_ERROR_OF_MEAN|0.35||0.515|TWO_SIDED|95.0|-0.91|0.46||Statistical testing, 2-sided, was done at 5% significance level.|ANOVA|||Baseline- after the training: Mixed linear model with participant as random effect, treatment group, visit and the interaction between treatment group and visit as fixed factors and with an auto-regressive correlation structure was used to calculate 95% CI.||0.46|-0.91|0.515
72599803|NCT00482170|144729629|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.07|STANDARD_ERROR_OF_MEAN|0.34||0.842|TWO_SIDED|95.0|-0.74|0.6||Statistical testing, 2-sided, was done at 5% significance level.|ANOVA|||Week 4: Mixed linear model with participant as random effect, treatment group, visit and the interaction between treatment group and visit as fixed factors and with an unstructured correlation was used for the analysis.||0.60|-0.74|0.842
72599804|NCT00482170|144729629|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.03|STANDARD_ERROR_OF_MEAN|0.33||0.928|TWO_SIDED|95.0|-0.67|0.61||Statistical testing, 2-sided, was done at 5% significance level.|ANOVA|||Week 12: Mixed linear model with participant as random effect, treatment group, visit and the interaction between treatment group and visit as fixed factors and with an unstructured correlation was used for the analysis.||0.61|-0.67|0.928
72599805|NCT00482170|144729629|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.32||0.974|TWO_SIDED|95.0|-0.62|0.64||Statistical testing, 2-sided, was done at 5% significance level.|ANOVA|||Last observation: ANOVA method was used for the analysis.||0.64|-0.62|0.974
72599806|NCT00482170|144729630|SUPERIORITY_OR_OTHER|||||||0.03||95.0|||||ANOVA|||p-value for statistical difference between all categories in the etanercept 50 mg auto-injector group was calculated using ANOVA.||||0.030
72599807|NCT00482170|144729630|SUPERIORITY_OR_OTHER|||||||0.01||95.0|||||ANOVA|||p-value for statistical difference between all categories in the etanercept 50 mg prefilled syringe group was calculated using ANOVA.||||0.010
72599808|NCT00482170|144729631|SUPERIORITY_OR_OTHER|||||||0.984||95.0|||||Chi-squared|||p-value for statistical difference between all categories in the etanercept 50 mg auto-injector group was calculated.||||0.984
72599809|NCT00482170|144729631|SUPERIORITY_OR_OTHER|||||||0.549||95.0|||||Chi-squared|||p-value for statistical difference between all categories in the etanercept 50 mg prefilled syringe group was calculated.||||0.549
72599810|NCT00482170|144729632|SUPERIORITY_OR_OTHER|||||||0.158||95.0|||||Fisher Exact|||p-value for statistical difference between all categories in the etanercept 50 mg auto-injector group was calculated.||||0.158
72599811|NCT00482170|144729632|SUPERIORITY_OR_OTHER|||||||0.808||95.0|||||Chi-squared|||p-value for statistical difference between all categories in the etanercept 50 mg prefilled syringe group was calculated.||||0.808
72599812|NCT00482170|144729633|SUPERIORITY_OR_OTHER|||||||0.029||95.0|||||Kruskal-Wallis|||p-value for statistical difference between categories, very satisfied: HAD-A, satisfied: HAD-A and less satisfied: HAD-A, in the etanercept 50 mg auto-injector group was calculated.||||0.029
72599813|NCT00482170|144729633|SUPERIORITY_OR_OTHER|||||||0.005||95.0|||||Kruskal-Wallis|||p-value for statistical difference between categories, very satisfied: HAD-A, satisfied: HAD-A and less satisfied: HAD-A, in the etanercept 50 mg prefilled syringe group was calculated.||||0.005
72599814|NCT00482170|144729633|SUPERIORITY_OR_OTHER|||||||0.411||95.0|||||Kruskal-Wallis|||p-value for statistical difference between categories, very satisfied: HAD-D, satisfied: HAD-D and less satisfied: HAD-D, in the etanercept 50 mg auto-injector group was calculated.||||0.411
72415920|NCT02962908|144342780|OTHER|inequality||||||0.23|||||||Wilcoxon (Mann-Whitney)|||Comparison of the difference in median fold increase in number of CD8+ T cells positive for CD107a from day 0 to day 180.||||0.23
72599815|NCT00482170|144729633|SUPERIORITY_OR_OTHER|||||||0.005||95.0|||||Kruskal-Wallis|||p-value for statistical difference between categories, very satisfied: HAD-D, satisfied: HAD-D and less satisfied: HAD-D, in the etanercept 50 mg prefilled syringe group was calculated.||||0.005
72599816|NCT00482170|144729634|SUPERIORITY_OR_OTHER|||||||0.039||95.0|||||ANOVA|||p-value for statistical difference between all categories in the etanercept 50 mg auto-injector group was calculated.||||0.039
72599817|NCT00482170|144729634|SUPERIORITY_OR_OTHER|||||||0.006||95.0|||||ANOVA|||p-value for statistical difference between all categories in the etanercept 50 mg prefilled syringe group was calculated.||||0.006
72599818|NCT00482170|144729635|SUPERIORITY_OR_OTHER|||||||0.752||95.0|||||Chi-squared|||p-value for statistical difference between all categories in the etanercept 50 mg auto-injector group was calculated.||||0.752
72599819|NCT00482170|144729635|SUPERIORITY_OR_OTHER|||||||0.7||95.0|||||Chi-squared|||p-value for statistical difference between all categories in the etanercept 50 mg prefilled syringe group was calculated.||||0.700
72599820|NCT00482170|144729636|SUPERIORITY_OR_OTHER|||||||0.697||95.0|||||Fisher Exact|||p-value for statistical difference between all categories in the etanercept 50 mg auto-injector group was calculated.||||0.697
72599821|NCT00482170|144729636|SUPERIORITY_OR_OTHER|||||||0.159||95.0|||||Chi-squared|||p-value for statistical difference between all categories in the etanercept 50 mg prefilled syringe group was calculated.||||0.159
72599822|NCT00482170|144729637|SUPERIORITY_OR_OTHER|||||||0.004||95.0|||||ANOVA|||p-value for statistical difference between all categories in the etanercept 50 mg auto-injector group was calculated.||||0.004
72599823|NCT00482170|144729637|SUPERIORITY_OR_OTHER|||||||0.024||95.0|||||ANOVA|||p-value for statistical difference between all categories in the etanercept 50 mg prefilled syringe group was calculated.||||0.024
72415921|NCT02962908|144342781|OTHER|inequality test||||||0.8|||||||Chi-squared|||Comparison of CD4+ IFNgamma responders on day 42. Differences considered significant if p-value \<0.05.||||0.80
72415922|NCT02962908|144342781|OTHER|inequality test|||||<|0.001|||||||Fisher Exact|||Comparison of CD4+ IFNgamma responders on day 42. Differences considered significant if p-value \<0.05.||||<0.001
72415923|NCT02962908|144342781|OTHER|inequality test||||||0.23|||||||Chi-squared|||Comparison of CD4+ TNF alpha responders on day 42. Differences considered significant if p-value \<0.05.||||0.23
72599824|NCT00482170|144729638|SUPERIORITY_OR_OTHER|||||||0.652||95.0|||||Kruskal-Wallis|||p-value for statistical difference between all categories in the etanercept 50 mg auto-injector group was calculated.||||0.652
72599825|NCT00482170|144729638|SUPERIORITY_OR_OTHER|||||||0.024||95.0|||||Kruskal-Wallis|||p-value for statistical difference between all categories in the etanercept 50 mg prefilled syringe group was calculated.||||0.024
72415924|NCT02962908|144342781|OTHER|||||||0.056|||||||Chi-squared|||Comparison of CD4+ TNF alpha responders on day 42. Differences considered significant if p-value \<0.05.||||0.056
72415925|NCT02962908|144342781|OTHER|inequality test||||||0.74|||||||Chi-squared|||Comparison of CD4+ IL-2 responders on day 42. Differences considered significant if p-value \<0.05.||||0.74
72415926|NCT02962908|144342781|OTHER|inequality test|||||<|0.001|||||||Chi-squared|||Comparison of CD4+ IL-2 responders on day 42. Differences considered significant if p-value \<0.05.||||<0.001
72415927|NCT02962908|144342781|OTHER|inequality test||||||0.34|||||||Fisher Exact|||Comparison of CD4+ CD107a responders on day 42. Differences considered significant if p-value \<0.05.||||0.34
72415928|NCT02962908|144342781|OTHER|inequality test||||||0.01|||||||Fisher Exact|||Comparison of CD4+ CD107a responders on day 42. Differences considered significant if p-value \<0.05.||||0.010
72415929|NCT02962908|144342781|OTHER|inequality test||||||0.096|||||||Chi-squared|||Comparison of CD4+ IFNgamma responders on day 180. Differences considered significant if p-value \<0.05.||||0.096
72599826|NCT00482170|144729639|SUPERIORITY_OR_OTHER|||||||0.56||95.0|||||ANOVA|||p-value for statistical difference between all categories in the etanercept 50 mg auto-injector group was calculated.||||0.560
72599827|NCT00482170|144729639|SUPERIORITY_OR_OTHER|||||||0.474||95.0|||||ANOVA|||p-value for statistical difference between all categories in the etanercept 50 mg prefilled syringe group was calculated.||||0.474
72599828|NCT00482170|144729640|SUPERIORITY_OR_OTHER|||||||0.023||95.0|||||ANOVA|||p-value for statistical difference between all categories in the etanercept 50 mg auto-injector group was calculated.||||0.023
72599829|NCT00482170|144729640|SUPERIORITY_OR_OTHER|||||||0.089||95.0|||||ANOVA|||p-value for statistical difference between all categories in the etanercept 50 mg prefilled syringe group was calculated.||||0.089
72415930|NCT02962908|144342781|OTHER|inequality test||||||0.049|||||||Fisher Exact|||Comparison of CD4+ IFNgamma responders on day 180.Differences considered significant if p-value \<0.05.||||0.049
72599830|NCT00482170|144729641|SUPERIORITY_OR_OTHER|||||||0.494||95.0|||||ANOVA|||p-value for statistical difference between all categories in the etanercept 50 mg auto-injector group was calculated.||||0.494
72599831|NCT00482170|144729641|SUPERIORITY_OR_OTHER|||||||0.782||95.0|||||ANOVA|||p-value for statistical difference between all categories in the etanercept 50 mg prefilled syringe group was calculated.||||0.782
72599832|NCT00482170|144729642|SUPERIORITY_OR_OTHER|||||||0.444||95.0|||||ANOVA|||p-value for statistical difference between all categories in the etanercept 50 mg auto-injector group was calculated.||||0.444
72599833|NCT00482170|144729642|SUPERIORITY_OR_OTHER|||||||0.947||95.0|||||ANOVA|||p-value for statistical difference between all categories in the etanercept 50 mg prefilled syringe group was calculated.||||0.947
72599834|NCT00482170|144729643|SUPERIORITY_OR_OTHER|||||||0.787||95.0|||||Chi-squared|||p-value for statistical difference between categories, very satisfied: tobacco usage- yes, very satisfied: tobacco usage- no, satisfied: tobacco usage- yes, satisfied: tobacco usage- no, less satisfied: tobacco usage- yes and less satisfied: tobacco usage- no, in the etanercept 50 mg auto-injector group was calculated.||||0.787
72599835|NCT00482170|144729643|SUPERIORITY_OR_OTHER|||||||0.379||95.0|||||Chi-squared|||p-value for statistical difference between categories, very satisfied: tobacco usage- yes, very satisfied: tobacco usage- no, satisfied: tobacco usage- yes, satisfied: tobacco usage- no, less satisfied: tobacco usage- yes and less satisfied: tobacco usage- no, in the etanercept 50 mg prefilled syringe group was calculated.||||0.379
72599836|NCT00482170|144729643|SUPERIORITY_OR_OTHER|||||||0.098||95.0|||||Chi-squared|||p-value for statistical difference between categories, very satisfied: alcohol usage- yes, very satisfied: alcohol usage- no, satisfied: alcohol usage- yes, satisfied: alcohol usage- no, less satisfied: alcohol usage- yes and less satisfied: alcohol usage- no, in the etanercept 50 mg auto-injector group was calculated.||||0.098
72599837|NCT00482170|144729643|SUPERIORITY_OR_OTHER|||||||0.166||95.0|||||Chi-squared|||p-value for statistical difference between categories, very satisfied: alcohol usage- yes, very satisfied: alcohol usage- no, satisfied: alcohol usage- yes, satisfied: alcohol usage- no, less satisfied: alcohol usage- yes and less satisfied: alcohol usage- no, in the etanercept 50 mg prefilled syringe group was calculated.||||0.166
72599838|NCT00482170|144729644|SUPERIORITY_OR_OTHER|||||||0.535||95.0|||||Fisher Exact|||p-value for statistical difference between all categories in the etanercept 50 mg prefilled syringe group was calculated.||||0.535
72599839|NCT04333225|144729679|OTHER|Other: estimating risk reduction|Risk Ratio (RR)|2.0718||||0.0112|TWO_SIDED|95.0|1.15|3.72|||Chi-squared|||||3.72|1.15|0.0112
72599840|NCT04333225|144729680|OTHER|Other: Estimating hazard ratio|Hazard Ratio (HR)|0.35||||0.0105|TWO_SIDED|95.0|0.17|0.75|||Log Rank|||||0.75|0.17|0.0105
72599841|NCT04399538|144729685|SUPERIORITY||Difference in least square (LS) mean|-52.36|||<|0.0001||80.0|-60.07|-43.17|||ANCOVA|||Natural log-transformed individual relative change (RC) from baseline to Week 6 was analyzed using the ANCOVA model with treatment as a fixed effect, natural log-transformed baseline % liver fat by MRI-PDFF as covariate. Values were back-transformed from the log scale.||-43.17|-60.07|<0.0001
72599842|NCT04399538|144729685|SUPERIORITY||Difference in LS mean|-56.58|||<|0.0001||80.0|-63.88|-47.8|||ANCOVA|||Natural log-transformed individual relative change (RC) from baseline to Week 6 was analyzed using the ANCOVA model with treatment as a fixed effect, natural log-transformed baseline % liver fat by MRI-PDFF as covariate. Values were back-transformed from the log scale.||-47.80|-63.88|<0.0001
72415931|NCT02962908|144342781|OTHER|inequality test||||||0.91|||||||Chi-squared|||Comparison of CD4+ TNF alpha responders on day 180. Differences considered significant if p-value \<0.05.||||0.91
72599843|NCT04399538|144729685|SUPERIORITY||Difference in LS mean|-58.8|||<|0.0001||80.0|-65.66|-50.57|||ANCOVA|||Natural log-transformed individual relative change (RC) from baseline to Week 6 was analyzed using the ANCOVA model with treatment as a fixed effect, natural log-transformed baseline % liver fat by MRI-PDFF as covariate. Values were back-transformed from the log scale. Relative change was converted to percent change as follows: Percent change = 100\*(RC-1). 80% CI was calculated based on difference in LS mean between groups.||-50.57|-65.66|<0.0001
72599844|NCT04399538|144729685|SUPERIORITY||Difference in LS mean|-45.8||||0.0003||80.0|-55.86|-33.46|||ANCOVA|||Natural log-transformed individual relative change (RC) from baseline to Week 6 was analyzed using the ANCOVA model with treatment as a fixed effect, natural log-transformed baseline % liver fat by MRI-PDFF as covariate. Values were back-transformed from the log scale.||-33.46|-55.86|0.0003
72599845|NCT01420016|144729693|EQUIVALENCE|The analysis used a time-by-condition mixed model to estimate the annual rate of change in post-index CV risk values by treatment group. The models included fixed effects for study arm (CDS vs. UC), time (years since index), and study-arm-by-time comparing the rate of change in CDS versus UC and a random clinic intercept. The intervention effect was the difference in rate of change in CDS versus UC clinics, with the study-arm-by-time interaction assessing statistical significance (P\<0.05).|Slope Difference (Net)|-2.25|||<|0.05|TWO_SIDED|95.0|-3.45|-1.04||A priori power analysis (power=.80, α2=.05) estimated detectable group difference in CVR at 1 year of \~2-3%, assuming 18 clinics, 1000 patients per clinic (actual 400), 3 CVR per patient (actual 2.3), and ICC=.01-03 (actual .019). p-value calculated.|Mixed Models Analysis||The intervention effect was the difference in annualized rates of change (slope) in CV risk in CDS versus UC clinics, with the study-arm-by-time interaction assessing statistical significance (P\<0.05).|||-1.04|-3.45|<0.05
72599846|NCT02187029|144729701|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-52.55|||||TWO_SIDED|90.0|-56.32|-48.78|||Bayesian ANCOVA|||||-48.780|-56.320|
72599847|NCT02187029|144729701|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-66.31|||||TWO_SIDED|90.0|-71.31|-61.54|||Bayesian ANCOVA|||||-61.540|-71.310|
72599848|NCT02187029|144729706|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.13||||90.0|-0.55|-0.06|||Mixed Models Analysis|||Day 1, Hour 1||-0.06|-0.55|
72599849|NCT02187029|144729706|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.62|STANDARD_ERROR_OF_MEAN|0.19|||TWO_SIDED|90.0|-0.95|-0.28|||Mixed Models Analysis|||Day 1, Hour 2||-0.28|-0.95|
72599850|NCT02187029|144729706|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.34|STANDARD_ERROR_OF_MEAN|0.1|||TWO_SIDED|90.0|-1.52|-1.16|||Mixed Models Analysis|||Day 1, Hour 4||-1.16|-1.52|
72599851|NCT02187029|144729706|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.86|STANDARD_ERROR_OF_MEAN|0.29|||TWO_SIDED|90.0|-2.38|-1.33|||Mixed Models Analysis|||Day 1, Hour 8||-1.33|-2.38|
72415932|NCT02962908|144342781|OTHER|||||||0.39|||||||Chi-squared|||Comparison of CD4+ TNF alpha responders on day 180. Differences considered significant if p-value \<0.05.||||0.39
72599852|NCT02187029|144729706|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.83|STANDARD_ERROR_OF_MEAN|0.19|||TWO_SIDED|90.0|-2.18|-1.48|||Mixed Models Analysis|||Day 1, Hour 12||-1.48|-2.18|
72599853|NCT02187029|144729706|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.74|STANDARD_ERROR_OF_MEAN|0.2|||TWO_SIDED|90.0|-2.11|-1.37|||Mixed Models Analysis|||Day 1, Hour 24||-1.37|-2.11|
72599854|NCT02187029|144729706|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.48|STANDARD_ERROR_OF_MEAN|0.23|||TWO_SIDED|90.0|-2.89|-2.06|||Mixed Models Analysis|||Day 3||-2.06|-2.89|
72599855|NCT02187029|144729706|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.75|STANDARD_ERROR_OF_MEAN|0.3|||TWO_SIDED|90.0|-3.29|-2.2|||Mixed Models Analysis|||Day 7, pre-dose||-2.20|-3.29|
72599856|NCT02187029|144729706|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.8|STANDARD_ERROR_OF_MEAN|0.33|||TWO_SIDED|90.0|-3.39|-2.21|||Mixed Models Analysis|||Day 7, Hour 1||-2.21|-3.39|
72599857|NCT02187029|144729706|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.06|STANDARD_ERROR_OF_MEAN|0.36|||TWO_SIDED|90.0|-3.72|-2.41|||Mixed Models Analysis|||Day 7, Hour 2||-2.41|-3.72|
72415933|NCT02962908|144342781|OTHER|inequality test||||||0.94|||||||Chi-squared|||Comparison of CD4+ IL-2 responders on day 180. Differences considered significant if p-value \<0.05.||||0.94
72415934|NCT02962908|144342781|OTHER|inequality test|||||<|0.001|||||||Fisher Exact|||Comparison of CD4+ IL-2 responders on day 180. Differences considered significant if p-value \<0.05.||||<0.001
72599858|NCT02187029|144729706|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.4|STANDARD_ERROR_OF_MEAN|0.35|||TWO_SIDED|90.0|-4.03|-2.77|||Mixed Models Analysis|||Day7, Hour 4||-2.77|-4.03|
72599859|NCT02187029|144729706|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.3|STANDARD_ERROR_OF_MEAN|0.28|||TWO_SIDED|90.0|-3.82|-2.79|||Mixed Models Analysis|||Day 7, Hour 8||-2.79|-3.82|
72599860|NCT02187029|144729706|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.2|STANDARD_ERROR_OF_MEAN|0.28|||TWO_SIDED|90.0|-3.72|-2.68|||Mixed Models Analysis|||Day 7, Hour 12||-2.68|-3.72|
72599861|NCT02187029|144729706|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.81|STANDARD_ERROR_OF_MEAN|0.27|||TWO_SIDED|90.0|-3.3|-2.32|||Mixed Models Analysis|||Day 7, Hour 24||-2.32|-3.30|
72599862|NCT02187029|144729706|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.56|STANDARD_ERROR_OF_MEAN|0.35|||TWO_SIDED|90.0|-5.19|-3.92|||Mixed Models Analysis|||Day 11||-3.92|-5.19|
72599863|NCT02187029|144729706|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.32|STANDARD_ERROR_OF_MEAN|0.23|||TWO_SIDED|90.0|-4.75|-3.88|||Mixed Models Analysis|||Day 14, pre-dose||-3.88|-4.75|
72415935|NCT02962908|144342781|OTHER|inequality test||||||0.044|||||||Fisher Exact|||Comparison of CD4+ CD107a responders on day 180. Differences considered significant if p-value \<0.05.||||0.044
72415936|NCT02962908|144342781|OTHER|inequality test||||||0.98|||||||Fisher Exact|||Comparison of CD4+ CD107a responders on day 180. Differences considered significant if p-value \<0.05.||||0.98
72415937|NCT02962908|144342781|OTHER|inequality test||||||0.48|||||||Chi squared or Fisher's exact test|||Comparison of CD8+ IFN-gamma responders on day 42. Differences considered significant if p-value \<0.05.||||0.48
72415938|NCT02962908|144342781|OTHER|inequality test||||||0.28|||||||Chi squared or Fisher's exact test|||Comparison of CD8+ IFN-gamma responders on day 42. Differences considered significant if p-value \<0.05.||||0.28
72415939|NCT02962908|144342781|OTHER|inequality test||||||0.7|||||||Chi squared or Fisher's exact test|||Comparison of CD8+ TNF-alpha responders on day 42. Differences considered significant if p-value \<0.05.||||0.70
72599864|NCT02187029|144729706|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.55|STANDARD_ERROR_OF_MEAN|0.25|||TWO_SIDED|90.0|-5.02|-4.08|||Mixed Models Analysis|||Day 14, Hour 1||-4.08|-5.02|
72599865|NCT02187029|144729706|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.97|STANDARD_ERROR_OF_MEAN|0.27|||TWO_SIDED|90.0|-5.47|-4.47|||Mixed Models Analysis|||Day 14, Hour 2||-4.47|-5.47|
72599866|NCT02187029|144729706|SUPERIORITY_OR_OTHER||LS Mean Difference|-5.43|STANDARD_ERROR_OF_MEAN|0.22|||TWO_SIDED|90.0|-5.83|-5.02|||Mixed Models Analysis|||Day 14, Hour 4||-5.02|-5.83|
72599867|NCT02187029|144729706|SUPERIORITY_OR_OTHER||LS Mean Difference|-5.57|STANDARD_ERROR_OF_MEAN|0.28|||TWO_SIDED|90.0|-6.08|-5.05|||Mixed Models Analysis|||Day 14, Hour 8||-5.05|-6.08|
72599868|NCT02187029|144729706|SUPERIORITY_OR_OTHER||LS Mean Difference|-5.34|STANDARD_ERROR_OF_MEAN|0.28|||TWO_SIDED|90.0|-5.86|-4.82|||Mixed Models Analysis|||Day 14, Hour 12||-4.82|-5.86|
72599869|NCT02187029|144729706|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.65|STANDARD_ERROR_OF_MEAN|0.25|||TWO_SIDED|90.0|-5.12|-4.18|||Mixed Models Analysis|||Day 14, Hour 24||-4.18|-5.12|
72599870|NCT02187029|144729706|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.09|STANDARD_ERROR_OF_MEAN|1.03|||TWO_SIDED|90.0|-2.97|0.79|||Mixed Models Analysis|||Follow-up, Day 25-29||0.79|-2.97|
72599871|NCT02187029|144729706|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.62|STANDARD_ERROR_OF_MEAN|0.17|||TWO_SIDED|90.0|-0.92|-0.32|||Mixed Models Analysis|||Day 1, Hour 1||-0.32|-0.92|
72599872|NCT02187029|144729706|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.18|STANDARD_ERROR_OF_MEAN|0.24|||TWO_SIDED|90.0|-1.61|-0.75|||Mixed Models Analysis|||Day 1, Hour 2||-0.75|-1.61|
72599873|NCT02187029|144729706|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.91|STANDARD_ERROR_OF_MEAN|0.12|||TWO_SIDED|90.0|-3.14|-2.69|||Mixed Models Analysis|||Day 1, Hour 4||-2.69|-3.14|
72599874|NCT02187029|144729706|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.7|STANDARD_ERROR_OF_MEAN|0.37|||TWO_SIDED|90.0|-4.36|-3.03|||Mixed Models Analysis|||Day 1, Hour 8||-3.03|-4.36|
72599875|NCT02187029|144729706|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.84|STANDARD_ERROR_OF_MEAN|0.24|||TWO_SIDED|90.0|-4.28|-3.4|||Mixed Models Analysis|||Day 1, Hour 12||-3.40|-4.28|
72599876|NCT02187029|144729706|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.47|STANDARD_ERROR_OF_MEAN|0.26||||90.0|-3.94|-3.0|||Mixed Models Analysis|||Day 1, Hour 24||-3.00|-3.94|
72599877|NCT02187029|144729706|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.76|STANDARD_ERROR_OF_MEAN|0.29|||TWO_SIDED|90.0|-5.29|-4.23|||Mixed Models Analysis|||Day 3||-4.23|-5.29|
72415940|NCT02962908|144342781|OTHER|inequality test||||||0.175|||||||Chi squared or Fisher's exact test|||Comparison of CD8+ TNF-alpha responders on day 42. Differences considered significant if p-value \<0.05.||||0.175
72415941|NCT02962908|144342781|OTHER|inequality test||||||0.24|||||||Chi squared or Fisher's exact test|||Comparison of CD8+ IL2 responders on day 42. Differences considered significant if p-value \<0.05.||||0.24
72599878|NCT02187029|144729706|SUPERIORITY_OR_OTHER||LS Mean Difference|-5.81|STANDARD_ERROR_OF_MEAN|0.45|||TWO_SIDED|90.0|-6.62|-5.0|||Mixed Models Analysis|||Day 7, pre-dose||-5.00|-6.62|
72599879|NCT02187029|144729706|SUPERIORITY_OR_OTHER||LS Mean Difference|-5.84|STANDARD_ERROR_OF_MEAN|0.49|||TWO_SIDED|90.0|-6.72|-4.95|||Mixed Models Analysis|||Day 7, Hour 1||-4.95|-6.72|
72599880|NCT02187029|144729706|SUPERIORITY_OR_OTHER||LS Mean Difference|-6.18|STANDARD_ERROR_OF_MEAN|0.55|||TWO_SIDED|90.0|-7.17|-5.19|||Mixed Models Analysis|||Day 7, Hour 2||-5.19|-7.17|
72599881|NCT02187029|144729706|SUPERIORITY_OR_OTHER||LS Mean Difference|-6.51|STANDARD_ERROR_OF_MEAN|0.53|||TWO_SIDED|90.0|-7.46|-5.55|||Mixed Models Analysis|||Day 7, Hour 4||-5.55|-7.46|
72599882|NCT02187029|144729706|SUPERIORITY_OR_OTHER||LS Mean Difference|-6.29|STANDARD_ERROR_OF_MEAN|0.43|||TWO_SIDED|90.0|-7.07|-5.51|||Mixed Models Analysis|||Day 7, Hour 8||-5.51|-7.07|
72599883|NCT02187029|144729706|SUPERIORITY_OR_OTHER||LS Mean Difference|-6.24|STANDARD_ERROR_OF_MEAN|0.44|||TWO_SIDED|90.0|-7.03|-5.44|||Mixed Models Analysis|||Day 7, Hour 12||-5.44|-7.03|
72599884|NCT02187029|144729706|SUPERIORITY_OR_OTHER||LS Mean Difference|-5.75|STANDARD_ERROR_OF_MEAN|0.42|||TWO_SIDED|90.0|-6.5|-4.99|||Mixed Models Analysis|||Day 7, Hour 24||-4.99|-6.50|
72599885|NCT02187029|144729706|SUPERIORITY_OR_OTHER||LS Mean Difference|-5.62|STANDARD_ERROR_OF_MEAN|0.53|||TWO_SIDED|90.0|-6.59|-4.65|||Mixed Models Analysis|||Day 11||-4.65|-6.59|
72599886|NCT02187029|144729706|SUPERIORITY_OR_OTHER||LS Mean Difference|-5.76|STANDARD_ERROR_OF_MEAN|0.36|||TWO_SIDED|90.0|-6.42|-5.1|||Mixed Models Analysis|||Day 14, pre-dose||-5.10|-6.42|
72599887|NCT02187029|144729706|SUPERIORITY_OR_OTHER||LS Mean Difference|-5.96|STANDARD_ERROR_OF_MEAN|0.39|||TWO_SIDED|90.0|-6.67|-5.24|||Mixed Models Analysis|||Day 14, Hour 1||-5.24|-6.67|
72599888|NCT02187029|144729706|SUPERIORITY_OR_OTHER||LS Mean Difference|-6.14|STANDARD_ERROR_OF_MEAN|0.41|||TWO_SIDED|90.0|-6.9|-5.38|||Mixed Models Analysis|||Day 14, Hour 2||-5.38|-6.90|
72599889|NCT02187029|144729706|SUPERIORITY_OR_OTHER||LS Mean Difference|-6.42|STANDARD_ERROR_OF_MEAN|0.33|||TWO_SIDED|90.0|-7.03|-5.81|||Mixed Models Analysis|||Day 14, Hour 4||-5.81|-7.03|
72599890|NCT02187029|144729706|SUPERIORITY_OR_OTHER||LS Mean Difference|-6.64|STANDARD_ERROR_OF_MEAN|0.42|||TWO_SIDED|90.0|-7.41|-5.87|||Mixed Models Analysis|||Day 14, Hour 8||-5.87|-7.41|
72599891|NCT02187029|144729706|SUPERIORITY_OR_OTHER||LS Mean Difference|-6.4|STANDARD_ERROR_OF_MEAN|0.42|||TWO_SIDED|90.0|-7.18|-5.63|||Mixed Models Analysis|||Day 14, Hour 12||-5.63|-7.18|
72415942|NCT02962908|144342781|OTHER|inequality test||||||0.8|||||||Chi squared or Fisher's exact test|||Comparison of CD8+ IL2 responders on day 42. Differences considered significant if p-value \<0.05.||||0.80
72599892|NCT02187029|144729706|SUPERIORITY_OR_OTHER||LS Mean Difference|-5.77|STANDARD_ERROR_OF_MEAN|0.38|||TWO_SIDED|90.0|-6.47|-5.07|||Mixed Models Analysis|||Day 14, Hour 24||-5.07|-6.47|
72415943|NCT02962908|144342781|OTHER|inequality test||||||0.023|||||||Chi squared or Fisher's exact test|||Comparison of CD8+ CD107a responders on day 42. Differences considered significant if p-value \<0.05.||||0.023
72599893|NCT02187029|144729706|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.66|STANDARD_ERROR_OF_MEAN|1.26|||TWO_SIDED|90.0|-4.96|-0.35|||Mixed Models Analysis|||Follow-up, Day 25-29||-0.35|-4.96|
72599894|NCT02187029|144729712|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.0355|STANDARD_ERROR_OF_MEAN|0.0423|||TWO_SIDED|90.0|-0.1103|0.0394|||Mixed Models Analysis|||Day 1, Hour 1||0.0394|-0.1103|
72599895|NCT02187029|144729712|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.0152|STANDARD_ERROR_OF_MEAN|0.0631|||TWO_SIDED|90.0|-0.1269|0.0966|||Mixed Models Analysis|||Day 1, Hour 2||0.0966|-0.1269|
72599896|NCT02187029|144729712|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.0331|STANDARD_ERROR_OF_MEAN|0.0422|||TWO_SIDED|90.0|-0.1078|0.0417|||Mixed Models Analysis|||Day 1, Hour 4||0.0417|-0.1078|
72599897|NCT02187029|144729712|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0035|STANDARD_ERROR_OF_MEAN|0.0443|||TWO_SIDED|90.0|-0.075|0.082|||Mixed Models Analysis|||Day 1, Hour 8||0.0820|-0.0750|
72599898|NCT02187029|144729712|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.0502|STANDARD_ERROR_OF_MEAN|0.0367|||TWO_SIDED|90.0|-0.1153|0.0149|||Mixed Models Analysis|||Day 1, Hour 12||0.0149|-0.1153|
72599899|NCT02187029|144729712|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.008|STANDARD_ERROR_OF_MEAN|0.0553|||TWO_SIDED|90.0|-0.1058|0.0899|||Mixed Models Analysis|||Day 1, Hour 24||0.0899|-0.1058|
72599900|NCT02187029|144729712|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.0539|STANDARD_ERROR_OF_MEAN|0.0561|||TWO_SIDED|90.0|-0.1538|0.046|||Mixed Models Analysis|||Day 7, pre-dose||0.0460|-0.1538|
72599901|NCT02187029|144729712|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0109|STANDARD_ERROR_OF_MEAN|0.0506|||TWO_SIDED|90.0|-0.0793|0.101|||Mixed Models Analysis|||Day 7, Hour 1||0.1010|-0.0793|
72599902|NCT02187029|144729712|SUPERIORITY_OR_OTHER||LS Mean Difference|0.033|STANDARD_ERROR_OF_MEAN|0.0496|||TWO_SIDED|90.0|-0.0554|0.1213|||Mixed Models Analysis|||Day 7, Hour 2||0.1213|-0.0554|
72599903|NCT02187029|144729712|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0086|STANDARD_ERROR_OF_MEAN|0.0459|||TWO_SIDED|90.0|-0.0733|0.0905|||Mixed Models Analysis|||Day 7, Hour 4||0.0905|-0.0733|
72599904|NCT02187029|144729712|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.0244|STANDARD_ERROR_OF_MEAN|0.0349|||TWO_SIDED|90.0|-0.0865|0.0378|||Mixed Models Analysis|||Day 7, Hour 8||0.0378|-0.0865|
72599905|NCT02187029|144729712|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.0526|STANDARD_ERROR_OF_MEAN|0.0251|||TWO_SIDED|90.0|-0.0973|-0.0079|||Mixed Models Analysis|||Day 7, Hour 12||-0.0079|-0.0973|
72599906|NCT02187029|144729712|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.0298|STANDARD_ERROR_OF_MEAN|0.0331|||TWO_SIDED|90.0|-0.0889|0.0292|||Mixed Models Analysis|||Day 7, Hour 24||0.0292|-0.0889|
72599907|NCT02187029|144729712|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.0167|STANDARD_ERROR_OF_MEAN|0.0268|||TWO_SIDED|90.0|-0.0649|0.0315|||Mixed Models Analysis|||Day 14, pre-dose||0.0315|-0.0649|
72599908|NCT02187029|144729712|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0616|STANDARD_ERROR_OF_MEAN|0.0337|||TWO_SIDED|90.0|0.001|0.1222|||Mixed Models Analysis|||Day 14, Hour 1||0.1222|0.0010|
72599909|NCT02187029|144729712|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1025|STANDARD_ERROR_OF_MEAN|0.0512|||TWO_SIDED|90.0|0.0104|0.1945|||Mixed Models Analysis|||Day 14, Hour 2||0.1945|0.0104|
72599910|NCT02187029|144729712|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0062|STANDARD_ERROR_OF_MEAN|0.0495|||TWO_SIDED|90.0|-0.0827|0.0952|||Mixed Models Analysis|||Day 14, Hour 4||0.0952|-0.0827|
72599911|NCT02187029|144729712|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0124|STANDARD_ERROR_OF_MEAN|0.0443|||TWO_SIDED|90.0|-0.0672|0.0919|||Mixed Models Analysis|||Day 14, Hour 8||0.0919|-0.0672|
72415944|NCT02962908|144342781|OTHER|inequality test||||||0.015|||||||Chi squared or Fisher's exact test|||Comparison of CD8+ CD107a responders on day 42. Differences considered significant if p-value \<0.05.||||0.015
72415945|NCT02962908|144342781|OTHER|inequality test||||||0.81|||||||Chi squared or Fisher's exact test|||Comparison of CD8+ IFN-gamma responders on day 180. Differences considered significant if p-value \<0.05.||||0.81
72415946|NCT02962908|144342781|OTHER|inequality test||||||0.34|||||||Chi squared or Fisher's exact test|||Comparison of CD8+ IFN-gamma responders on day 180. Differences considered significant if p-value \<0.05.||||0.34
72599912|NCT02187029|144729712|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.0186|STANDARD_ERROR_OF_MEAN|0.0408|||TWO_SIDED|90.0|-0.0918|0.0547|||Mixed Models Analysis|||Day 14, Hour 12||0.0547|-0.0918|
72599913|NCT02187029|144729712|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.0413|STANDARD_ERROR_OF_MEAN|0.0433|||TWO_SIDED|90.0|-0.1192|0.0365|||Mixed Models Analysis|||Day 14, Hour 24||0.0365|-0.1192|
72599914|NCT02187029|144729712|SUPERIORITY_OR_OTHER||LS Mean Difference|0.4011|STANDARD_ERROR_OF_MEAN|0.3916|||TWO_SIDED|90.0|-0.2968|1.099|||Mixed Models Analysis|||Follow-up, Day 25-29||1.0990|-0.2968|
72599915|NCT02187029|144729712|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1175|STANDARD_ERROR_OF_MEAN|0.0537|||TWO_SIDED|90.0|0.0223|0.2127|||Mixed Models Analysis|||Day 1, Hour 1||0.2127|0.0223|
72599916|NCT02187029|144729712|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3845|STANDARD_ERROR_OF_MEAN|0.0802|||TWO_SIDED|90.0|0.2424|0.5266|||Mixed Models Analysis|||Day 1, Hour 2||0.5266|0.2424|
72599917|NCT02187029|144729712|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3812|STANDARD_ERROR_OF_MEAN|0.0536|||TWO_SIDED|90.0|0.2862|0.4762|||Mixed Models Analysis|||Day 1, Hour 4||0.4762|0.2862|
72599918|NCT02187029|144729712|SUPERIORITY_OR_OTHER||LS Mean Difference|0.2841|STANDARD_ERROR_OF_MEAN|0.0563|||TWO_SIDED|90.0|0.1843|0.3838|||Mixed Models Analysis|||Day 1, Hour 8||0.3838|0.1843|
72599919|NCT02187029|144729712|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1462|STANDARD_ERROR_OF_MEAN|0.0467|||TWO_SIDED|90.0|0.0635|0.2289|||Mixed Models Analysis|||Day 1, Hour 12||0.2289|0.0635|
72599920|NCT02187029|144729712|SUPERIORITY_OR_OTHER||LS Mean Difference|0.168|STANDARD_ERROR_OF_MEAN|0.0702|||TWO_SIDED|90.0|0.0436|0.2924|||Mixed Models Analysis|||Day 1, Hour 24||0.2924|0.0436|
72599921|NCT02187029|144729712|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1303|STANDARD_ERROR_OF_MEAN|0.083|||TWO_SIDED|90.0|-0.0172|0.2778|||Mixed Models Analysis|||Day 7, pre-dose||0.2778|-0.0172|
72599922|NCT02187029|144729712|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1953|STANDARD_ERROR_OF_MEAN|0.0747||||90.0|0.0625|0.3281|||Mixed Models Analysis|||Day 7, Hour 1||0.3281|0.0625|
72599923|NCT02187029|144729712|SUPERIORITY_OR_OTHER||LS Mean Difference|0.5409|STANDARD_ERROR_OF_MEAN|0.0729|||TWO_SIDED|90.0|0.411|0.6707|||Mixed Models Analysis|||Day 7, Hour 2||0.6707|0.4110|
72599924|NCT02187029|144729712|SUPERIORITY_OR_OTHER||LS Mean Difference|0.5235|STANDARD_ERROR_OF_MEAN|0.0675|||TWO_SIDED|90.0|0.4032|0.6438|||Mixed Models Analysis|||Day 7, Hour 4||0.6438|0.4032|
72599925|NCT02187029|144729712|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3857|STANDARD_ERROR_OF_MEAN|0.0512|||TWO_SIDED|90.0|0.2944|0.4769|||Mixed Models Analysis|||Day 7, Hour 8||0.4769|0.2944|
72599926|NCT02187029|144729712|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0216|STANDARD_ERROR_OF_MEAN|0.0368|||TWO_SIDED|90.0|-0.0439|0.0872|||Mixed Models Analysis|||Day 7, Hour 12||0.0872|-0.0439|
72599927|NCT02187029|144729712|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1708|STANDARD_ERROR_OF_MEAN|0.0486|||TWO_SIDED|90.0|0.0841|0.2574|||Mixed Models Analysis|||Day 7, Hour 24||0.2574|0.0841|
72599928|NCT02187029|144729712|SUPERIORITY_OR_OTHER||LS Mean Difference|0.166|STANDARD_ERROR_OF_MEAN|0.0377|||TWO_SIDED|90.0|0.0982|0.2338|||Mixed Models Analysis|||Day 14, pre-dose||0.2338|0.0982|
72415947|NCT02962908|144342781|OTHER|inequality test||||||0.3|||||||Chi squared or Fisher's exact test|||Comparison of CD8+ TNF-alpha responders on day 180. Differences considered significant if p-value \<0.05.||||0.30
72599929|NCT02187029|144729712|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3524|STANDARD_ERROR_OF_MEAN|0.0477|||TWO_SIDED|90.0|0.2667|0.438|||Mixed Models Analysis|||Day 14, Hour 1||0.4380|0.2667|
72599930|NCT02187029|144729712|SUPERIORITY_OR_OTHER||LS Mean Difference|0.5631|STANDARD_ERROR_OF_MEAN|0.0724|||TWO_SIDED|90.0|0.433|0.6932|||Mixed Models Analysis|||Day 14, Hour 2||0.6932|0.4330|
72599931|NCT02187029|144729712|SUPERIORITY_OR_OTHER||LS Mean Difference|0.5807|STANDARD_ERROR_OF_MEAN|0.07|||TWO_SIDED|90.0|0.4549|0.7065|||Mixed Models Analysis|||Day 14, Hour 4||0.7065|0.4549|
72599932|NCT02187029|144729712|SUPERIORITY_OR_OTHER||LS Mean Difference|0.2814|STANDARD_ERROR_OF_MEAN|0.0627|||TWO_SIDED|90.0|0.1688|0.394|||Mixed Models Analysis|||Day 14, Hour 8||0.3940|0.1688|
72599933|NCT02187029|144729712|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1982|STANDARD_ERROR_OF_MEAN|0.0577|||TWO_SIDED|90.0|0.0945|0.3019|||Mixed Models Analysis|||Day 14, Hour 12||0.3019|0.0945|
72599934|NCT02187029|144729712|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1465|STANDARD_ERROR_OF_MEAN|0.0615|||TWO_SIDED|90.0|0.0361|0.2569|||Mixed Models Analysis|||Day 14, Hour 24||0.2569|0.0361|
72599935|NCT02187029|144729712|SUPERIORITY_OR_OTHER||LS Mean Difference|0.8565|STANDARD_ERROR_OF_MEAN|0.4796|||TWO_SIDED|90.0|0.0017|1.7112|||Mixed Models Analysis|||Follow-up, Day 25-29||1.7112|0.0017|
72599936|NCT02187029|144729713|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.348|STANDARD_ERROR_OF_MEAN|0.209|||TWO_SIDED|90.0|-0.707|0.01|||Mixed Models Analysis|||Day 1, Hour 1||0.010|-0.707|
72599937|NCT02187029|144729713|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.179|STANDARD_ERROR_OF_MEAN|0.205|||TWO_SIDED|90.0|-0.533|0.175|||Mixed Models Analysis|||Day 1, Hour 2||0.175|-0.533|
72599938|NCT02187029|144729713|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.258|STANDARD_ERROR_OF_MEAN|0.18|||TWO_SIDED|90.0|-0.568|0.052|||Mixed Models Analysis|||Day 1, Hour 4||0.052|-0.568|
72599939|NCT02187029|144729713|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.046|STANDARD_ERROR_OF_MEAN|0.201||||90.0|-0.39|0.298|||Mixed Models Analysis|||Day 1, Hour 8||0.298|-0.390|
72599940|NCT02187029|144729713|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.284|STANDARD_ERROR_OF_MEAN|0.168||||90.0|-0.575|0.006|||Mixed Models Analysis|||Day 1, Hour 12||0.006|-0.575|
72599941|NCT02187029|144729713|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.166|STANDARD_ERROR_OF_MEAN|0.235|||TWO_SIDED|90.0|-0.569|0.237|||Mixed Models Analysis|||Day 1, Hour 24||0.237|-0.569|
72599942|NCT02187029|144729713|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.263|STANDARD_ERROR_OF_MEAN|0.23|||TWO_SIDED|90.0|-0.657|0.132|||Mixed Models Analysis|||Day 7, pre-dose||0.132|-0.657|
72599943|NCT02187029|144729713|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.221|||TWO_SIDED|90.0|-0.46|0.299|||Mixed Models Analysis|||Day 7, Hour 1||0.299|-0.460|
72599944|NCT02187029|144729713|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.082|STANDARD_ERROR_OF_MEAN|0.18|||TWO_SIDED|90.0|-0.392|0.228|||Mixed Models Analysis|||Day 7, Hour 2||0.228|-0.392|
72599945|NCT02187029|144729713|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.083|STANDARD_ERROR_OF_MEAN|0.189|||TWO_SIDED|90.0|-0.408|0.242|||Mixed Models Analysis|||Day 7, Hour 4||0.242|-0.408|
72599946|NCT02187029|144729713|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.207|STANDARD_ERROR_OF_MEAN|0.174|||TWO_SIDED|90.0|-0.508|0.095|||Mixed Models Analysis|||Day 7, Hour 8||0.095|-0.508|
72599947|NCT02187029|144729713|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.186|||TWO_SIDED|90.0|-0.451|0.191|||Mixed Models Analysis|||Day 7, Hour 12||0.191|-0.451|
72599948|NCT02187029|144729713|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.125|STANDARD_ERROR_OF_MEAN|0.186|||TWO_SIDED|90.0|-0.445|0.196|||Mixed Models Analysis|||Day 7, Hour 24||0.196|-0.445|
72599949|NCT02187029|144729713|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.188|STANDARD_ERROR_OF_MEAN|0.162|||TWO_SIDED|90.0|-0.472|0.097|||Mixed Models Analysis|||Day 14, pre-dose||0.097|-0.472|
72599950|NCT02187029|144729713|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.152|STANDARD_ERROR_OF_MEAN|0.161|||TWO_SIDED|90.0|-0.434|0.13|||Mixed Models Analysis|||Day 14, Hour 1||0.130|-0.434|
72599951|NCT02187029|144729713|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.231|STANDARD_ERROR_OF_MEAN|0.155|||TWO_SIDED|90.0|-0.504|0.043|||Mixed Models Analysis|||Day 14, Hour 2||0.043|-0.504|
72599952|NCT02187029|144729713|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.405|STANDARD_ERROR_OF_MEAN|0.184|||TWO_SIDED|90.0|-0.722|-0.088|||Mixed Models Analysis|||Day 14, Hour 4||-0.088|-0.722|
72599953|NCT02187029|144729713|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.249|STANDARD_ERROR_OF_MEAN|0.18|||TWO_SIDED|90.0|-0.56|0.062|||Mixed Models Analysis|||Day 14, Hour 8||0.062|-0.560|
72599954|NCT02187029|144729713|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.163|STANDARD_ERROR_OF_MEAN|0.176|||TWO_SIDED|90.0|-0.467|0.141|||Mixed Models Analysis|||Day 14, Hour 12||0.141|-0.467|
72599955|NCT02187029|144729713|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.317|STANDARD_ERROR_OF_MEAN|0.183|||TWO_SIDED|90.0|-0.633|-0.002|||Mixed Models Analysis|||Day 14, Hour 24||-0.002|-0.633|
72599956|NCT02187029|144729713|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.094|STANDARD_ERROR_OF_MEAN|0.339|||TWO_SIDED|90.0|-0.683|0.496|||Mixed Models Analysis|||Follow-up, Day 25-29||0.496|-0.683|
72415948|NCT02962908|144342781|OTHER|inequality test||||||0.105|||||||Chi squared or Fisher's exact test|||Comparison of CD8+ TNF-alpha responders on day 180. Differences considered significant if p-value \<0.05.||||0.105
72599957|NCT02187029|144729713|SUPERIORITY_OR_OTHER||LS Mean Difference|0.05|STANDARD_ERROR_OF_MEAN|0.266|||TWO_SIDED|90.0|-0.406|0.505|||Mixed Models Analysis|||Day 1, Hour 1||0.505|-0.406|
72599958|NCT02187029|144729713|SUPERIORITY_OR_OTHER||LS Mean Difference|0.257|STANDARD_ERROR_OF_MEAN|0.26|||TWO_SIDED|90.0|-0.193|0.707|||Mixed Models Analysis|||Day 1, Hour 2||0.707|-0.193|
72599959|NCT02187029|144729713|SUPERIORITY_OR_OTHER||LS Mean Difference|0.091|STANDARD_ERROR_OF_MEAN|0.229|||TWO_SIDED|90.0|-0.302|0.485|||Mixed Models Analysis|||Day 1, Hour 4||0.485|-0.302|
72599960|NCT02187029|144729713|SUPERIORITY_OR_OTHER||LS Mean Difference|0.33|STANDARD_ERROR_OF_MEAN|0.256|||TWO_SIDED|90.0|-0.107|0.768|||Mixed Models Analysis|||Day 1, Hour 8||0.768|-0.107|
72599961|NCT02187029|144729713|SUPERIORITY_OR_OTHER||LS Mean Difference|0.283|STANDARD_ERROR_OF_MEAN|0.214|||TWO_SIDED|90.0|-0.087|0.653|||Mixed Models Analysis|||Day 1, Hour 12||0.653|-0.087|
72599962|NCT02187029|144729713|SUPERIORITY_OR_OTHER||LS Mean Difference|0.488|STANDARD_ERROR_OF_MEAN|0.299|||TWO_SIDED|90.0|-0.024|1.0|||Mixed Models Analysis|||Day 1, Hour 24||1.000|-0.024|
72599963|NCT02187029|144729713|SUPERIORITY_OR_OTHER||LS Mean Difference|0.206|STANDARD_ERROR_OF_MEAN|0.327|||TWO_SIDED|90.0|-0.356|0.768|||Mixed Models Analysis|||Day 7, pre-dose||0.768|-0.356|
72599964|NCT02187029|144729713|SUPERIORITY_OR_OTHER||LS Mean Difference|0.123|STANDARD_ERROR_OF_MEAN|0.31|||TWO_SIDED|90.0|-0.41|0.656|||Mixed Models Analysis|||Day 7, Hour 1||0.656|-0.410|
72599965|NCT02187029|144729713|SUPERIORITY_OR_OTHER||LS Mean Difference|0.396|STANDARD_ERROR_OF_MEAN|0.246|||TWO_SIDED|90.0|-0.025|0.818|||Mixed Models Analysis|||Day 7, Hour 2||0.818|-0.025|
72599966|NCT02187029|144729713|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.077|STANDARD_ERROR_OF_MEAN|0.26|||TWO_SIDED|90.0|-0.523|0.368|||Mixed Models Analysis|||Day 7, Hour 4||0.368|-0.523|
72599967|NCT02187029|144729713|SUPERIORITY_OR_OTHER||LS Mean Difference|0.254|STANDARD_ERROR_OF_MEAN|0.237|||TWO_SIDED|90.0|-0.154|0.661|||Mixed Models Analysis|||Day 7, Hour 8||0.661|-0.154|
72599968|NCT02187029|144729713|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.125|STANDARD_ERROR_OF_MEAN|0.256|||TWO_SIDED|90.0|-0.564|0.315|||Mixed Models Analysis|||Day 7, Hour 12||0.315|-0.564|
72599969|NCT02187029|144729713|SUPERIORITY_OR_OTHER||LS Mean Difference|0.458|STANDARD_ERROR_OF_MEAN|0.256|||TWO_SIDED|90.0|0.019|0.897|||Mixed Models Analysis|||Day 7, Hour 24||0.897|0.019|
72415949|NCT02962908|144342781|OTHER|inequality test||||||0.38|||||||Chi squared or Fisher's exact test|||Comparison of CD8+ IL2 responders on day 180. Differences considered significant if p-value \<0.05.||||0.38
72599970|NCT02187029|144729713|SUPERIORITY_OR_OTHER||LS Mean Difference|0.418|STANDARD_ERROR_OF_MEAN|0.215|||TWO_SIDED|90.0|0.043|0.792|||Mixed Models Analysis|||Day 14, pre-dose||0.792|0.043|
72599971|NCT02187029|144729713|SUPERIORITY_OR_OTHER||LS Mean Difference|0.521|STANDARD_ERROR_OF_MEAN|0.213|||TWO_SIDED|90.0|0.15|0.893|||Mixed Models Analysis|||Day 14, Hour 1||0.893|0.150|
72599972|NCT02187029|144729713|SUPERIORITY_OR_OTHER||LS Mean Difference|0.53|STANDARD_ERROR_OF_MEAN|0.204|||TWO_SIDED|90.0|0.172|0.888|||Mixed Models Analysis|||Day 14, Hour 2||0.888|0.172|
72415950|NCT02962908|144342781|OTHER|inequality test||||||0.44|||||||Chi squared or Fisher's exact test|||Comparison of CD8+ IL2 responders on day 180. Differences considered significant if p-value \<0.05.||||0.44
72415951|NCT02962908|144342781|OTHER|inequality test||||||0.58|||||||Chi squared or Fisher's exact test|||Comparison of CD8+ CD107a responders on day 180. Differences considered significant if p-value \<0.05.||||0.58
72599973|NCT02187029|144729713|SUPERIORITY_OR_OTHER||LS Mean Difference|0.357|STANDARD_ERROR_OF_MEAN|0.247|||TWO_SIDED|90.0|-0.069|0.782|||Mixed Models Analysis|||Day 14, Hour 4||0.782|-0.069|
72599974|NCT02187029|144729713|SUPERIORITY_OR_OTHER||LS Mean Difference|0.088|STANDARD_ERROR_OF_MEAN|0.242|||TWO_SIDED|90.0|-0.328|0.503|||Mixed Models Analysis|||Day 14, Hour 8||0.503|-0.328|
72415952|NCT02962908|144342781|OTHER|inequality test||||||0.43|||||||Chi squared or Fisher's exact test|||Comparison of CD8+ CD107a responders on day 180. Differences considered significant if p-value \<0.05.||||0.43
72599975|NCT02187029|144729713|SUPERIORITY_OR_OTHER||LS Mean Difference|0.406|STANDARD_ERROR_OF_MEAN|0.236|||TWO_SIDED|90.0|0.0|0.812|||Mixed Models Analysis|||Day 14, Hour 12||0.812|0.000|
72599976|NCT02187029|144729713|SUPERIORITY_OR_OTHER||LS Mean Difference|0.377|STANDARD_ERROR_OF_MEAN|0.247|||TWO_SIDED|90.0|-0.047|0.802|||Mixed Models Analysis|||Day 14, Hour 24||0.802|-0.047|
72415953|NCT02962908|144342782|OTHER|inequality test||||||0.25|||||||Fisher Exact|||Comparison of responders determined by MIMOSA analysis of CD4+ T-cell producing IFN-gamma at day 42||||0.25
72599977|NCT02187029|144729713|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.223|STANDARD_ERROR_OF_MEAN|0.418|||TWO_SIDED|90.0|-0.949|0.502|||Mixed Models Analysis|||Follow-up, Day 25-29||0.502|-0.949|
72599978|NCT02187029|144729714|SUPERIORITY_OR_OTHER||LS Mean Difference|316.89|STANDARD_ERROR_OF_MEAN|166.57|||TWO_SIDED|90.0|21.91|611.88|||Mixed Models Analysis|||Day 1||611.88|21.91|
72599979|NCT02187029|144729714|SUPERIORITY_OR_OTHER||LS Mean Difference|61.97|STANDARD_ERROR_OF_MEAN|88.27|||TWO_SIDED|90.0|-94.87|218.82|||Mixed Models Analysis|||Day 7||218.82|-94.87|
72599980|NCT02187029|144729714|SUPERIORITY_OR_OTHER||LS Mean Difference|107.96|STANDARD_ERROR_OF_MEAN|100.38|||TWO_SIDED|90.0|-71.2|287.11|||Mixed Models Analysis|||Day 14||287.11|-71.20|
72599981|NCT02187029|144729714|SUPERIORITY_OR_OTHER||LS Mean Difference|433.21|STANDARD_ERROR_OF_MEAN|211.71|||TWO_SIDED|90.0|58.3|808.13|||Mixed Models Analysis|||Day 1||808.13|58.30|
72415954|NCT02962908|144342782|OTHER|inequality test||||||1|||||||Fisher Exact|||Comparison of responders determined by MIMOSA analysis of CD4+ T-cell producing TNF-alpha at day 42||||1.0
72599982|NCT02187029|144729714|SUPERIORITY_OR_OTHER||LS Mean Difference|13.2|STANDARD_ERROR_OF_MEAN|125.47|||TWO_SIDED|90.0|-208.07|234.47|||Mixed Models Analysis|||Day 7||234.47|-208.07|
72599983|NCT02187029|144729714|SUPERIORITY_OR_OTHER||LS Mean Difference|-29.83|STANDARD_ERROR_OF_MEAN|142.95|||TWO_SIDED|90.0|-285.26|225.6|||Mixed Models Analysis|||Day 14||225.60|-285.26|
72599984|NCT02187029|144729715|SUPERIORITY_OR_OTHER||LS Mean Difference|3.44|STANDARD_ERROR_OF_MEAN|1.57|||TWO_SIDED|90.0|0.71|6.17|||Mixed Models Analysis|||Day 1||6.17|0.71|
72415955|NCT02962908|144342782|OTHER|inequality test||||||1|||||||Fisher Exact|||Comparison of responders determined by MIMOSA analysis of CD4+ T-cell producing IL-2 at day 42||||1.00
72415956|NCT02962908|144342782|OTHER|inequality test||||||1|||||||Fisher Exact|||Comparison of responders determined by MIMOSA analysis of CD4+ T-cell producing CD107a at day 42||||1.00
72415957|NCT02962908|144342782|OTHER|inequality test|||||<|0.001|||||||Chi-squared|||Comparison of responders determined by MIMOSA analysis of CD4+ T-cell producing IFN-gamma at day 42||||<0.001
72415958|NCT02962908|144342782|OTHER|inequality test|||||<|0.001|||||||Chi-squared|||Comparison of responders determined by MIMOSA analysis of CD4+ T-cell producing TNF-alpha at day 42||||<0.001
72415959|NCT02962908|144342782|OTHER|inequality test|||||<|0.001|||||||Chi-squared|||Comparison of responders determined by MIMOSA analysis of CD4+ T-cell producing IL2 at day 42||||<0.001
72415960|NCT02962908|144342782|OTHER|inequality test||||||0.31|||||||Fisher Exact|||Comparison of responders determined by MIMOSA analysis of CD4+ T-cell producing CD107a at day 42||||0.31
72415961|NCT02962908|144342782|OTHER|inequality test||||||0.48|||||||Fisher Exact|||Comparison of responders determined by MIMOSA analysis of CD4+ T-cell producing IFN-gamma at day 180||||0.48
72599985|NCT02187029|144729715|SUPERIORITY_OR_OTHER||LS Mean Difference|3.67|STANDARD_ERROR_OF_MEAN|0.94|||TWO_SIDED|90.0|1.97|5.37|||Mixed Models Analysis|||Day 7||5.37|1.97|
72599986|NCT02187029|144729715|SUPERIORITY_OR_OTHER||LS Mean Difference|8.1|STANDARD_ERROR_OF_MEAN|1.03|||TWO_SIDED|90.0|6.24|9.96|||Mixed Models Analysis|||Day 14||9.96|6.24|
72599987|NCT02187029|144729715|SUPERIORITY_OR_OTHER||LS Mean Difference|13.12|STANDARD_ERROR_OF_MEAN|2.0|||TWO_SIDED|90.0|9.65|16.59|||Mixed Models Analysis|||Day 1||16.59|9.65|
72599988|NCT02187029|144729715|SUPERIORITY_OR_OTHER||LS Mean Difference|27.99|STANDARD_ERROR_OF_MEAN|1.4|||TWO_SIDED|90.0|25.49|30.49|||Mixed Models Analysis|||Day 7||30.49|25.49|
72599989|NCT02187029|144729715|SUPERIORITY_OR_OTHER||LS Mean Difference|28.77|STANDARD_ERROR_OF_MEAN|1.48|||TWO_SIDED|90.0|26.14|31.41|||Mixed Models Analysis|||Day 14||31.41|26.14|
72599990|NCT02187029|144729716|SUPERIORITY_OR_OTHER||LS Mean Difference|0.9|STANDARD_ERROR_OF_MEAN|1.29|||TWO_SIDED|90.0|-1.31|3.1|||Mixed Models Analysis|||Day 1||3.10|-1.31|
72599991|NCT02187029|144729716|SUPERIORITY_OR_OTHER||LS Mean Difference|2.91|STANDARD_ERROR_OF_MEAN|1.29|||TWO_SIDED|90.0|0.71|5.11|||Mixed Models Analysis|||Day 7||5.11|0.71|
72599992|NCT02187029|144729716|SUPERIORITY_OR_OTHER||LS Mean Difference|3.59|STANDARD_ERROR_OF_MEAN|1.33|||TWO_SIDED|90.0|1.33|5.85|||Mixed Models Analysis|||Day 14||5.85|1.33|
72415962|NCT02962908|144342782|OTHER|inequality test||||||1|||||||Fisher Exact|||Comparison of responders determined by MIMOSA analysis of CD4+ T-cell producing TNF-alpha at day 180||||1.00
72415963|NCT02962908|144342782|OTHER|inequality test||||||1|||||||Fisher Exact|||Comparison of responders determined by MIMOSA analysis of CD4+ T-cell producing IL2 at day 180||||1.00
72599993|NCT02187029|144729716|SUPERIORITY_OR_OTHER||LS Mean Difference|1.51|STANDARD_ERROR_OF_MEAN|1.64|||TWO_SIDED|90.0|-1.29|4.31|||Mixed Models Analysis|||Day 1||4.31|-1.29|
72599994|NCT02187029|144729716|SUPERIORITY_OR_OTHER||LS Mean Difference|7.73|STANDARD_ERROR_OF_MEAN|1.86|||TWO_SIDED|90.0|4.57|10.89|||Mixed Models Analysis|||Day 7||10.89|4.57|
72599995|NCT02187029|144729716|SUPERIORITY_OR_OTHER||LS Mean Difference|9.07|STANDARD_ERROR_OF_MEAN|1.86|||TWO_SIDED|90.0|5.91|12.23|||Mixed Models Analysis|||Day 14||12.23|5.91|
72599996|NCT01301079|144729754|SUPERIORITY_OR_OTHER|||||||0.113|TWO_SIDED||||||Mann-Whitney|||||||0.113
72599997|NCT01301079|144729755|SUPERIORITY_OR_OTHER|||||||0.946|TWO_SIDED||||||t-test, 2 sided|||||||0.946
72599998|NCT01301079|144729756|SUPERIORITY_OR_OTHER|||||||0.999|TWO_SIDED||||||t-test, 2 sided|||||||0.999
72599999|NCT01301079|144729757|SUPERIORITY_OR_OTHER|||||||0.019|TWO_SIDED||||||t-test, 2 sided|||||||0.019
72600000|NCT01301079|144729758|SUPERIORITY_OR_OTHER|||||||0.652|TWO_SIDED||||||t-test, 2 sided|||||||0.652
72600001|NCT01301079|144729759|SUPERIORITY_OR_OTHER|||||||0.221|TWO_SIDED||||||t-test, 2 sided|||||||0.221
72415964|NCT02962908|144342782|OTHER|inequality test||||||0.59|||||||Fisher Exact|||Comparison of responders determined by MIMOSA analysis of CD4+ T-cell producing CD107a at day 180||||0.59
72415965|NCT02962908|144342782|OTHER|inequality test|||||<|0.001|||||||Chi-squared|||Comparison of responders determined by MIMOSA analysis of CD4+ T-cell producing IFN-gamma at day 180||||<0.001
72415966|NCT02962908|144342782|OTHER|inequality test||||||0.013|||||||Fisher Exact|||Comparison of responders determined by MIMOSA analysis of CD4+ T-cell producing TNF-alpha at day 180||||0.013
72600002|NCT01301079|144729760|SUPERIORITY_OR_OTHER|||||||0.325|TWO_SIDED||||||t-test, 2 sided|||||||0.325
72600003|NCT01301079|144729761|SUPERIORITY_OR_OTHER|||||||0.386|TWO_SIDED||||||t-test, 2 sided|||||||0.386
72600004|NCT01301079|144729762|SUPERIORITY_OR_OTHER|||||||0.499|TWO_SIDED||||||t-test, 1 sided|||||||0.499
72600005|NCT01301079|144729763|SUPERIORITY_OR_OTHER|||||||0.909|TWO_SIDED||||||t-test, 2 sided|||||||0.909
72600006|NCT01301079|144729764|SUPERIORITY_OR_OTHER|||||||0.737|TWO_SIDED||||||t-test, 2 sided|||||||0.737
72600007|NCT01301079|144729765|SUPERIORITY_OR_OTHER||||||<|0.872|TWO_SIDED||||||t-test, 2 sided|||||||<0.872
72600008|NCT01301079|144729766|SUPERIORITY_OR_OTHER|||||||0.598|TWO_SIDED||||||t-test, 2 sided|||||||0.598
72600009|NCT01301079|144729767|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.0||||0.485|TWO_SIDED|95.0|||||t-test, 2 sided|||||||0.485
72600010|NCT01301079|144729768|SUPERIORITY_OR_OTHER|||||||0.744|TWO_SIDED||||||t-test, 2 sided|||||||0.744
72600011|NCT01301079|144729769|SUPERIORITY_OR_OTHER|||||||0.54|TWO_SIDED||||||t-test, 2 sided|||||||0.540
72600012|NCT01301079|144729770|SUPERIORITY_OR_OTHER|||||||0.673|TWO_SIDED||||||t-test, 2 sided|||||||0.673
72600013|NCT01301079|144729771|SUPERIORITY_OR_OTHER|||||||0.586|TWO_SIDED||||||t-test, 2 sided|||||||0.586
72600014|NCT01301079|144729772|SUPERIORITY_OR_OTHER|||||||0.077|TWO_SIDED||||||t-test, 2 sided|||||||0.077
72600015|NCT01301079|144729773|SUPERIORITY_OR_OTHER|||||||0.677|TWO_SIDED||||||t-test, 2 sided|||||||0.677
72600016|NCT01301079|144729774|SUPERIORITY_OR_OTHER|||||||0.545|TWO_SIDED||||||t-test, 2 sided|||||||0.545
72600017|NCT01301079|144729775|SUPERIORITY_OR_OTHER|||||||0.65|TWO_SIDED||||||t-test, 2 sided|||||||0.650
72600018|NCT01301079|144729776|SUPERIORITY_OR_OTHER|||||||0.593|TWO_SIDED||||||t-test, 2 sided|||||||0.593
72600019|NCT01301079|144729777|SUPERIORITY_OR_OTHER|||||||0.313|TWO_SIDED||||||Chi-squared|||||||0.313
72600020|NCT01301079|144729778|SUPERIORITY_OR_OTHER|||||||0.313|TWO_SIDED||||||Chi-squared|||||||0.313
72600021|NCT01301079|144729779|SUPERIORITY_OR_OTHER|||||||0.313|TWO_SIDED||||||Chi-squared|||||||0.313
72600022|NCT01301079|144729780|SUPERIORITY_OR_OTHER|||||||0.611|TWO_SIDED||||||Chi-squared|||||||0.611
72600023|NCT01301079|144729781|SUPERIORITY_OR_OTHER|||||||0.312|TWO_SIDED||||||t-test, 2 sided|||||||0.312
72600024|NCT01301079|144729782|SUPERIORITY_OR_OTHER|||||||0.676|TWO_SIDED||||||t-test, 2 sided|||||||0.676
72600025|NCT01301079|144729783|SUPERIORITY_OR_OTHER|||||||0.938|TWO_SIDED||||||t-test, 2 sided|||||||0.938
72600026|NCT01301079|144729784|SUPERIORITY_OR_OTHER|||||||0.385|TWO_SIDED||||||t-test, 2 sided|||||||0.385
72600027|NCT01301079|144729785|SUPERIORITY_OR_OTHER|||||||0.422|TWO_SIDED||||||t-test, 2 sided|||||||0.422
72600028|NCT01301079|144729786|SUPERIORITY_OR_OTHER|||||||0.5|TWO_SIDED||||||t-test, 2 sided|||||||0.500
72600029|NCT01301079|144729787|SUPERIORITY_OR_OTHER|||||||0.435|TWO_SIDED||||||t-test, 2 sided|||||||0.435
72600030|NCT01301079|144729788|SUPERIORITY_OR_OTHER|||||||0.745|TWO_SIDED||||||t-test, 2 sided|||||||0.745
72600031|NCT01301079|144729789|SUPERIORITY_OR_OTHER|||||||0.557|TWO_SIDED||||||t-test, 2 sided|||||||0.557
72600032|NCT04472494|144729805|SUPERIORITY||Odds Ratio (OR)|1.07||||0.9297|TWO_SIDED|95.0|0.26|4.49|||Cochran-Mantel-Haenszel Chi-Square test|||||4.49|0.26|0.9297
72600033|NCT04472494|144729806|SUPERIORITY||Adjusted mean difference from Placebo|0.64||||0.74|TWO_SIDED|95.0|-0.55|1.82|||Cochran-Mantel-Haenszel|||||1.82|-0.55|0.7400
72600034|NCT04472494|144729807|SUPERIORITY||Estimate of Difference|-0.1||||0.9684|TWO_SIDED|95.0|-20.55|20.34|||Cochran-Mantel-Haenszel Chi-Square test||Estimate of Difference is based on minimum risk weights|||20.34|-20.55|0.9684
72600035|NCT04472494|144729808|SUPERIORITY||Odds Ratio (OR)|0.85||||0.8504|TWO_SIDED|95.0|0.18|3.97|||Cochran-Mantel-Haenszel|||||3.97|0.18|0.8504
72600036|NCT04472494|144729809|SUPERIORITY||Odds Ratio (OR)|2.29||||0.2724|TWO_SIDED|95.0|0.53|9.82|||Cochran-Mantel-Haenszel|||||9.82|0.53|0.2724
72600037|NCT04472494|144729809|SUPERIORITY||Estimate of difference|12.78|||||TWO_SIDED|95.0|-10.61|36.17|||||||Estimate of difference is based on minimum risk weights|36.17|-10.61|
72600038|NCT04472494|144729810|SUPERIORITY||Odds Ratio (OR)|2.03||||0.4734|TWO_SIDED|95.0|0.33|12.64|||Cochran-Mantel-Haenszel|||||12.64|0.33|0.4734
72600039|NCT04472494|144729810|SUPERIORITY||Estimate of difference|5.43|||||TWO_SIDED|95.0|-16.71|27.57|||||Estimate of difference is based on minimum risk weights|||27.57|-16.71|
72600040|NCT00571103|144729814|SUPERIORITY_OR_OTHER||Mean Slope|-0.985|STANDARD_ERROR_OF_MEAN|0.158||0.05|TWO_SIDED|95.0|-1.0|1.0|||Linear mixed effects|||||1|-1|0.05
72415967|NCT02962908|144342782|OTHER|inequality|||||<|0.001|||||||Chi-squared|||Comparison of responders determined by MIMOSA analysis of CD4+ T-cell producing IL2 at day 180||||<0.001
72415968|NCT02962908|144342782|OTHER|inequality test||||||1|||||||Fisher Exact|||Comparison of responders determined by MIMOSA analysis of CD4+ T-cell producing CD107a at day 180||||1.00
72415969|NCT02962908|144342782|OTHER|inequality test||||||0.55|||||||Fisher Exact|||Comparison of responders determined by MIMOSA analysis of CD8+ T-cell producing IFN-gamma at day 42||||0.55
72415970|NCT02962908|144342782|OTHER|inequality test||||||0.55|||||||Fisher Exact|||Comparison of responders determined by MIMOSA analysis of CD8+ T-cell producing IFN-gamma at day 42||||0.55
72415971|NCT02962908|144342782|OTHER|inequality test||||||1|||||||Fisher Exact|||Comparison of responders determined by MIMOSA analysis of CD8+ T-cell producing TNF-alpha at day 42||||1.00
72600041|NCT02131233|144729885|NON_INFERIORITY_OR_EQUIVALENCE|Reformulated Raltegravir is concluded non-inferior to Raltegravir if the lower bound of the 95% CI for the difference in percent response is above -10 percentage points.|Estimated Difference|0.51|||||TWO_SIDED|95.0|-4.204|5.223|||||Reformulated Raltegravir minus Raltegravir|The 95% Confidence Interval (CI) for the treatment differences in percent response were calculated using stratum-adjusted Mantel-Haenszel method with the difference weighted by the harmonic mean of sample size per arm for each stratum (screening HIV-1 RNA \<=100,000 copies/mL or HIV-1 RNA \>100,000 copies/mL)||5.223|-4.204|
72600042|NCT02131233|144729886|NON_INFERIORITY_OR_EQUIVALENCE|Reformulated Raltegravir is concluded non-inferior to Raltegravir if the lower bound of the 95% CI for the difference in percent response is above -10 percentage points.|Estimated Difference|1.449|||||TWO_SIDED|95.0|-4.41|7.308|||||Reformulated Raltegravir minus Raltegravir|The 95% Confidence Interval (CI) for the treatment differences in percent response were calculated using stratum-adjusted Mantel-Haenszel method with the difference weighted by the harmonic mean of sample size per arm for each stratum (screening HIV-1 RNA \<=100,000 copies/mL or HIV-1 RNA \>100,000 copies/mL)||7.308|-4.410|
72600043|NCT02131233|144729887|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.1|||||TWO_SIDED|95.0|-30.9|26.7|||||Reformulated Raltegravir minus Raltegravir|The 95% CI for mean difference in CD4 change was based on t-distribution.||26.7|-30.9|
72600044|NCT02131233|144729888|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6|||||TWO_SIDED|95.0|-32.8|31.6|||||Reformulated Raltegravir minus Raltegravir|The 95% CI for mean difference in CD4 change was based on t-distribution.||31.6|-32.8|
72600045|NCT02095197|144729931|SUPERIORITY_OR_OTHER|||||||0.23|||||||Fisher Exact|||||||0.23
72600046|NCT02095197|144729932|SUPERIORITY_OR_OTHER|||||||0.47|||||||Chi-squared|||||||0.47
72600047|NCT02095197|144729933|SUPERIORITY_OR_OTHER|||||||0.3|||||||Chi-squared|||||||0.30
72600048|NCT02095197|144729934|SUPERIORITY_OR_OTHER|||||||0.41|||||||Chi-squared|||||||0.41
72600049|NCT00368459|144729945|SUPERIORITY_OR_OTHER||||||>|0.1|TWO_SIDED||||||ANCOVA|||For this pilot trial, we did not anticipate power to detect significant, clinically-meaningful between-group differences of the magnitude provided by FDA-approved AD therapies over a 12 month treatment period, but we specified that we would report trends (alpha \<0.1) as a guide to future effectiveness studies.||||>0.1
72600050|NCT00368459|144729946|SUPERIORITY_OR_OTHER||||||>|0.1|TWO_SIDED||||||ANCOVA|||||||>0.1
72600051|NCT00368459|144729947|SUPERIORITY_OR_OTHER||||||>|0.1|TWO_SIDED||||||ANCOVA|||||||>0.1
72600052|NCT00368459|144729948|SUPERIORITY_OR_OTHER||||||>|0.1|TWO_SIDED||||||ANCOVA|||||||>0.1
72600053|NCT00368459|144729949|SUPERIORITY_OR_OTHER||||||>|0.1|TWO_SIDED||||||ANCOVA|||||||>0.1
72600054|NCT00368459|144729950|SUPERIORITY_OR_OTHER||||||>|0.1|TWO_SIDED||||||ANCOVA|||||||>0.1
72600055|NCT00368459|144729951|SUPERIORITY_OR_OTHER||||||>|0.1|TWO_SIDED||||||ANCOVA|||||||>0.1
72600056|NCT00368459|144729952|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED|||||Favoring placebo, unadjusted for multiple comparisons|ANCOVA|||||||<0.01
72600057|NCT00368459|144729953|SUPERIORITY_OR_OTHER||||||>|0.1|TWO_SIDED||||||ANCOVA|||||||>0.1
72600058|NCT00368459|144729954|SUPERIORITY_OR_OTHER||||||>|0.1|TWO_SIDED||||||ANCOVA|||||||>0.1
72600059|NCT01461473|144729986|SUPERIORITY_OR_OTHER|||||||0.2067|||||||Analysis of covariance (GLM)|||These data were analyzed using an analysis of covariance via general linear model (GLM). The GLM has an indicator variable for PAP vs. OA plus covariates for baseline apnea-hypopnea index, gender, site and baseline NMAP. The primary hypothesis tested is that the 2-month means differ between study arms, after adjustment for the above covariates. A Wald statistic was constructed for hypothesis testing.||||0.2067
72600060|NCT01461473|144729987|SUPERIORITY_OR_OTHER|||||||0.3902|||||||GLMM|||Generalized linear mixed model (GLMM) was fit in which the outcome was regressed on an indicator variable for PAP vs. OA, baseline apnea-hypopnea index, gender, site and baseline value of the outcome. A Wald statistic was constructed for hypothesis testing.||||0.3902
72600061|NCT01461473|144729988|SUPERIORITY_OR_OTHER|||||||0.9319|||||||GLMM|||A GLMM was fit in which the outcome was regressed on an indicator variable for PAP vs. OA, baseline apnea-hypopnea index, gender, site and baseline value of the outcome. A Wald statistic was constructed for hypothesis testing.||||0.9319
72600062|NCT01461473|144729989|SUPERIORITY_OR_OTHER|||||||0.3895|||||||GLMM|||A GLMM was fit in which the outcome was regressed on an indicator variable for PAP vs. OA, baseline apnea-hypopnea index, gender, site and baseline value of the outcome. A Wald statistic was constructed for hypothesis testing.||||0.3895
72600063|NCT01461473|144729990|SUPERIORITY_OR_OTHER|||||||0.3449|||||||see Comments|Analysis of covariance with robust MM regression due to extreme residuals from initial fit showing strong departure from normal distribution.||Using analysis of covariance (robust MM regression), the outcome was regressed on an indicator variable for PAP vs. OA, baseline outcome, baseline apnea-hypopnea index, gender, site, baseline brachial-artery diameter, body mass index, age, and the interaction of gender and study arm. The latter allows for the possibility that treatment effect may differ between males and females. A Wald statistic was constructed for hypothesis testing.||||0.3449
72600064|NCT01461473|144729991|SUPERIORITY_OR_OTHER|||||||0.1531|||||||see Comments|Analysis of covariance with robust MM regression due to extreme residuals from initial fit showing strong departure from normal distribution.||Using analysis of covariance (robust MM regression), the outcome was regressed on an indicator variable for PAP vs. OA, baseline outcome, baseline apnea-hypopnea index, gender, site, baseline brachial-artery diameter, body mass index, age, and the interaction of gender and study arm. The latter allows for the possibility that treatment effect may differ between males and females. A Wald statistic was constructed for hypothesis testing.||||0.1531
72600065|NCT01778751|144730033|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.0||||0.012|TWO_SIDED|95.0|-1.7|-0.2|||Mixed Models Analysis|||Comparison at 3 months||-0.2|-1.7|0.012
72600066|NCT01778751|144730033|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.0||||0.05|TWO_SIDED|95.0|-2.0|0.0|||Mixed Models Analysis|||Comparison at 6 months||-0.0|-2.0|0.050
72600067|NCT01778751|144730034|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.9||||0.303|TWO_SIDED|95.0|-2.7|8.4|||Mixed Models Analysis|||Comparison at 3 months, Scale is 0-100 where a higher score is a better outcome.||8.4|-2.7|0.303
72600068|NCT01778751|144730034|SUPERIORITY_OR_OTHER||Mean Difference (Net)|7.7||||0.027|TWO_SIDED|95.0|0.9|14.4|||Mixed Models Analysis|||Comparison at 6 months, Scale is 0-100 where a higher score is a better outcome.||14.4|0.9|0.027
72600069|NCT01778751|144730035|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.9||||0.83|TWO_SIDED|95.0|0.35|2.34|||Generalized estimating equation (GEE)|||||2.34|0.35|0.830
72600070|NCT01778751|144730035|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.02||||0.97|TWO_SIDED|95.0|0.33|3.19|||Generalized Estimating Equation (GEE)|||Comparison at 6 months||3.19|0.33|0.970
72600071|NCT01778751|144730036|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.9||||0.428|TWO_SIDED|95.0|-3.3|1.4|||Mixed Models Analysis|||Comparison at 3 months. Scale is 0-27 where a lower score is a better outcome, values were dichotomized to indicate whether or not the patient was depressed.||1.4|-3.3|0.428
72600072|NCT01778751|144730036|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.1||||0.397|TWO_SIDED|95.0|-1.4|3.6|||Mixed Models Analysis|||Comparison at 6 months. Scale is 0-27 where a lower score is a better outcome, values were dichotomized to indicate whether or not the patient was depressed.||3.6|-1.4|0.397
72600073|NCT01454414|144730037|SUPERIORITY_OR_OTHER_LEGACY||Protective effectiveness= 1 - rate ratio|0.646||||0.004|TWO_SIDED|95.0|0.288|0.824|||Poisson regression|||Protective effectiveness (1 - the incidence rate ratio) and 95% CIs for comparing reported tick bites between the treatment and control groups were calculated using a GEE model with a Poisson distribution and log link, and included terms for treatment, year of follow-up, and the interaction of treatment and year of follow-up, with an offset variable for log outdoor work hours.||0.824|0.288|0.004
72600074|NCT02685072|144730062|SUPERIORITY||Odds Ratio (OR)|0.5818||||0.3253|TWO_SIDED|95.0|0.1968|1.7202|||Chi-squared|degrees of freedom =1|Odds ratio represents odds of smoking abstinence in TPN + progesterone group versus TPN + placebo group|||1.7202|0.1968|0.3253
72600075|NCT02685072|144730063|SUPERIORITY||Odds Ratio (OR)|1.0781||||0.8944|TWO_SIDED|95.0|0.355|3.2744|||Chi-squared|degrees of freedom = 1|Odds ratio represents odds of CO \< 10 (negative for smoking) in TPN + progesterone versus TPN + placebo groups|||3.2744|0.3550|0.8944
72600076|NCT02685072|144730064|SUPERIORITY||Odds Ratio (OR)|0.7619||||0.662|TWO_SIDED|95.0|0.2247|2.5838|||Chi-squared|degrees of freedom = 1|Odds ratio represents odds of CO \< 10 ppm (negative for smoking) in TPN + progesterone versus TPN + placebo.|||2.5838|0.2247|0.6620
72600077|NCT02685072|144730065|SUPERIORITY||Odds Ratio (OR)|0.913||||0.8661|TWO_SIDED|95.0|0.3171|2.6287|||Chi-squared|degrees of freedom = 1|Odds ratio represents odds of CO \< 10 ppm (negative for smoking) in TPN + progesterone versus TPN + placebo.|||2.6287|0.3171|0.8661
72600078|NCT02685072|144730066|SUPERIORITY||Mean Difference (Final Values)|-9.1|STANDARD_DEVIATION|31.7||0.31|TWO_SIDED|95.0|-27.1|9.0|||t-test, 2 sided||(Placebo + TPN) - (Progesterone + TPN)|||9.0|-27.1|0.31
72600079|NCT02685072|144730067|SUPERIORITY||Mean Difference (Final Values)|0.148||||0.791|TWO_SIDED|95.0|-0.9747|1.2707|||t-test, 2 sided||(placebo + TPN) - (progesterone + TPN)|||1.2707|-0.9747|0.7910
72600080|NCT02685072|144730068|SUPERIORITY||Mean Difference (Final Values)|9.26||||0.0065|TWO_SIDED|95.0|2.71|15.81|||t-test, 2 sided|||||15.81|2.71|0.0065
72600081|NCT02685072|144730079|SUPERIORITY||Odds Ratio (OR)|0.7172||||0.6449|TWO_SIDED|95.0|0.1738|2.9594|||Chi-squared|degrees of freedom = 1|Odds ratio represents odds of CO \< 10 ppm (negative for smoking) in TPN + progesterone versus TPN + placebo.|||2.9594|0.1738|.6449
72600082|NCT02685072|144730080|SUPERIORITY||Odds Ratio (OR)|0.7172||||0.6449|TWO_SIDED|95.0|0.1738|2.9594|||Chi-squared|degrees of freedom = 1|Odds ratio represents odds of prolonged abstinence in TPN + progesterone versus TPN + placebo.|||2.9594|0.1738|0.6449
72600083|NCT02717442|144730092|SUPERIORITY||Risk Ratio (RR)|0.658|||=|0.029|TWO_SIDED|95.0|0.453|0.957||Study week was based on each 4-week interval and was modeled as a categorical variable, and an offset for the log of the number of diary entries recorded for each 4-week interval post-baseline was included for each subject.|Regression, Linear|||The primary efficacy endpoint was compared between OTO-104 and placebo at the 2-tailed 0.05 alpha level using a generalized Poisson linear mixed model. The model included fixed effects for randomized treatment group, sex, study week, a treatment group by study week interaction, and the count of lead-in period DVD standardized to 28 days as a covariate.||0.957|0.453|=0.029
72600084|NCT02717442|144730093|SUPERIORITY||Risk Ratio (RR)|0.59|||=|0.014|TWO_SIDED|95.0|0.388|0.896|||Regression, Linear|||The primary efficacy endpoint was compared between OTO-104 and placebo at the 2-tailed 0.05 alpha level using a generalized Poisson linear mixed model. The model included fixed effects for randomized treatment group, sex, study week, a treatment group by study week interaction, and the count of lead-in period DVD standardized to 28 days as a covariate.||0.896|0.388|=0.014
72600085|NCT02798354|144730100|SUPERIORITY||Risk Difference (RD)|3.9|||<|0.0001|TWO_SIDED|95.0|2.4|5.3|||Mixed Models Analysis||Fitted by generalized mixed-effects model with potential clustering effects of practices and months taken into account; adjusted for age, sex, insurance, and wave|||5.3|2.4|<0.0001
72600086|NCT02798354|144730101|SUPERIORITY||Risk Difference (RD)|16.0|||<|0.0001|TWO_SIDED|95.0|12.3|20.0|||Mixed Models Analysis||Fitted by generalized mixed-effects model with potential clustering effects of practices and months taken into account; adjusted for age, sex, insurance, and wave|||20|12.3|<0.0001
72415972|NCT02962908|144342782|OTHER|inequality test||||||0.29|||||||Fisher Exact|||Comparison of responders determined by MIMOSA analysis of CD8+ T-cell producing IFN-gamma at day 180||||0.29
72600087|NCT02798354|144730102|SUPERIORITY||Risk Difference (RD)|1.1||||0.302|TWO_SIDED|95.0|-1.0|3.1|||Mixed Models Analysis||Fitted by generalized mixed-effects model with potential clustering effects of practices and months taken into account; adjusted for age, sex, insurance, lab test sent, and wave|||3.1|-1.0|0.302
72600088|NCT02798354|144730103|SUPERIORITY||Risk Difference (RD)|26.6|||<|0.0001|TWO_SIDED|95.0|22.4|30.7|||Mixed Models Analysis||Fitted by generalized mixed-effects model with potential clustering effects of practices and months taken into account; adjusted for age, sex, insurance, and wave|||30.7|22.4|<0.0001
72600089|NCT02798354|144730104|SUPERIORITY||Risk Difference (RD)|20.1|||<|0.0001|TWO_SIDED|95.0|16.2|24.1|||Mixed Models Analysis||Fitted by generalized mixed-effects model with potential clustering effects of practices and months taken into account; adjusted for age, sex, insurance, and wave|||24.1|16.2|<0.0001
72600090|NCT02798354|144730105|SUPERIORITY||Risk Difference (RD)|14.0|||<|0.0001|TWO_SIDED|95.0|10.3|17.7|||Mixed Models Analysis||Fitted by generalized mixed-effects model with potential clustering effects of practices and months taken into account; adjusted for age, sex, insurance, and wave|||17.7|10.3|<0.0001
72600091|NCT02798354|144730106|SUPERIORITY||Risk Difference (RD)|0.1||||0.922|TWO_SIDED|95.0|-1.8|1.9|||Mixed Models Analysis||Fitted by generalized mixed-effects model with potential clustering effects of practices and months taken into account; adjusted for age, sex, insurance, lab test sent, and wave|||1.9|-1.8|0.922
72600092|NCT00528372|144730110|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.35|STANDARD_ERROR_OF_MEAN|0.1522||0.0207||||||Tested at alpha=0.019, applying the Dunnett adjustment|ANCOVA|||||||0.0207
72600093|NCT00528372|144730110|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.54|STANDARD_ERROR_OF_MEAN|0.1541||0.0005||||||Tested at alpha=0.019, applying the Dunnett adjustment|ANCOVA|||||||0.0005
72600094|NCT00528372|144730110|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.66|STANDARD_ERROR_OF_MEAN|0.1518|<|0.0001||||||Tested at alpha=0.019, applying the Dunnett adjustment|ANCOVA|||||||<0.0001
72415973|NCT02962908|144342782|OTHER|inequality test||||||1|||||||Fisher Exact|||Comparison of responders determined by MIMOSA analysis of CD8+ T-cell producing TNF-alpha at day 180||||1.00
72415974|NCT02962908|144342782|OTHER|inequality test||||||1|||||||Fisher Exact|||Comparison of responders determined by MIMOSA analysis of CD8+ T-cell producing IFN-gamma at day 180||||1.00
72415975|NCT02962908|144342782|OTHER|inequality test||||||1|||||||Fisher Exact|||Comparison of responders determined by MIMOSA analysis of CD8+ T-cell producing TNF-alpha at day 180||||1.00
72415976|NCT02962908|144342782|OTHER|inequality test||||||1|||||||Fisher Exact|||Comparison of responders determined by MIMOSA analysis of CD8+ T-cell producing CD107a at day 180||||1.00
72600095|NCT00528372|144730110|SUPERIORITY_OR_OTHER||Difference from placebo|-0.61|STANDARD_ERROR_OF_MEAN|0.1536|||TWO_SIDED|95.0|-0.91|-0.3||||||||-0.30|-0.91|
72415977|NCT02962908|144342783|OTHER|inequality test||||||0.59|||||||Wilcoxon (Mann-Whitney)|||Comparison of median fold-increase in IFN-gamma secretion as measured by ELISA on day 42. p\<0.05 considered statistically significant.||||0.59
72600096|NCT00528372|144730110|SUPERIORITY_OR_OTHER||Difference from placebo|-0.56|STANDARD_ERROR_OF_MEAN|0.1527|||TWO_SIDED|95.0|-0.86|-0.26||||||||-0.26|-0.86|
72600097|NCT00528372|144730110|SUPERIORITY_OR_OTHER||Difference from placebo|-0.56|STANDARD_ERROR_OF_MEAN|0.1474|||TWO_SIDED|95.0|-0.85|-0.27||||||||-0.27|-0.85|
72600098|NCT00528372|144730111|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.1|STANDARD_ERROR_OF_MEAN|5.734||||||||Sequential testing procedures were used, and no test was performed for this comparison due to the fact that the previous comparison was not significant.|||Week 24|||||
72415978|NCT02962908|144342783|OTHER|inequality test||||||0.001|||||||Wilcoxon (Mann-Whitney)|||Comparison of median fold-increase in IFN-gamma secretion as measured by ELISA on day 42. p\<0.05 considered statistically significant.||||0.001
72415979|NCT02962908|144342783|OTHER|inequality test||||||0.61|||||||Wilcoxon (Mann-Whitney)|||Comparison of median fold-increase in IFN-gamma secretion as measured by ELISA on day 180. p\<0.05 considered statistically significant.||||0.61
72415980|NCT02962908|144342783|OTHER|inequality test|||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Comparison of median fold-increase in IFN-gamma secretion as measured by ELISA on day 180. p\<0.05 considered statistically significant.||||<0.001
72415981|NCT02962908|144342784|OTHER|||||||0.113|||||||Wilcoxon (Mann-Whitney)|||"Comparison of number of responders on day 42. A subject was considered a responder if an increase of secreted IFNgamma of at least two fold was observed from day 0 to day 42."||||0.113
72415982|NCT02962908|144342784|OTHER||||||<|0.001|||||||Fisher Exact|||"Comparison of number of responders on day 42. A subject was considered a responder if an increase of secreted IFNgamma of at least two fold was observed from day 0 to day 42."||||<0.001
72415983|NCT02962908|144342784|OTHER|||||||0.399|||||||Chi-squared|||"Comparison of number of responders on day 180. A subject was considered a responder if an increase of secreted IFNgamma of at least two fold was observed from day 0 to day 180."||||0.399
72415984|NCT02962908|144342784|OTHER||||||<|0.001|||||||Fisher Exact|||"Comparison of number of responders on day 180. A subject was considered a responder if an increase of secreted IFNgamma of at least two fold was observed from day 0 to day 180."||||<0.001
72415985|NCT02962908|144342786|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Comparison of geometric mean IgG titers specific to FLU-v antigens on day 42 post-vaccination.||||<0.001
72415986|NCT02962908|144342786|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Comparison of geometric mean IgG titers specific to FLU-v antigens on day 42.||||<0.001
72415987|NCT02962908|144342786|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Comparison of geometric mean IgG titers specific to FLU-v antigens on day 180.||||<0.001
72415988|NCT02962908|144342786|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Comparison of geometric mean IgG titers specific to FLU-v antigens on day 180.||||<0.001
72600099|NCT00528372|144730111|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.9|STANDARD_ERROR_OF_MEAN|5.806||0.0007||||||Statistically significant according to hierarchical testing procedure (p\<0.05)|ANCOVA||Week 24|||||0.0007
72600100|NCT00528372|144730111|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-24.7|STANDARD_ERROR_OF_MEAN|5.626|<|0.0001||||||Statistically significant according to hierarchical testing procedure (p\<0.05)|ANCOVA||Week 24|||||<0.0001
72600101|NCT00528372|144730111|SUPERIORITY_OR_OTHER||Difference from placebo|-21.5|STANDARD_ERROR_OF_MEAN|5.686|||TWO_SIDED|95.0|-32.6|-10.3||||||||-10.3|-32.6|
72600102|NCT00528372|144730111|SUPERIORITY_OR_OTHER||Difference from placebo|-23.3|STANDARD_ERROR_OF_MEAN|5.711|||TWO_SIDED|95.0|-34.4|-12.0||||||||-12.0|-34.4|
72600103|NCT00528372|144730111|SUPERIORITY_OR_OTHER||Difference from placebo|-25.5|STANDARD_ERROR_OF_MEAN|5.567|||TWO_SIDED|95.0|-36.4|-14.5||||||||-14.5|-36.4|
72600104|NCT00528372|144730113|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.06|STANDARD_ERROR_OF_MEAN|0.6307||||||||Sequential testing procedures were used, and no test was performed for this comparison due to the fact that the previous comparison was not significant.||||||||
72600105|NCT00528372|144730113|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.65|STANDARD_ERROR_OF_MEAN|0.6388||0.3101||||||Tested following a sequential testing procedure at alpha=0.05.|ANCOVA|||||||0.3101
72600106|NCT00528372|144730113|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.97|STANDARD_ERROR_OF_MEAN|0.6223||0.1189||||||Tested following a sequential testing procedure at alpha=0.05.|ANCOVA|||||||0.1189
72600107|NCT00528372|144730113|SUPERIORITY_OR_OTHER||Difference from placebo|-1.63|STANDARD_ERROR_OF_MEAN|0.6254|||TWO_SIDED|95.0|-2.86|-0.41||||||||-0.41|-2.86|
72600108|NCT00528372|144730113|SUPERIORITY_OR_OTHER||Difference from placebo|-1.36|STANDARD_ERROR_OF_MEAN|0.6279|||TWO_SIDED|95.0|-2.6|-0.13||||||||-0.13|-2.60|
72600109|NCT00528372|144730113|SUPERIORITY_OR_OTHER||Difference from placebo|-0.87|STANDARD_ERROR_OF_MEAN|0.6103|||TWO_SIDED|95.0|-2.06|0.33||||||||0.33|-2.06|
72600110|NCT00528372|144730115|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|4.324||||||||||||||||
72600111|NCT00528372|144730115|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.9|STANDARD_ERROR_OF_MEAN|4.342||||||||||||||||
72600112|NCT00528372|144730115|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.6|STANDARD_ERROR_OF_MEAN|4.176||||||||||||||||
72600113|NCT00528372|144730115|SUPERIORITY_OR_OTHER||Difference from placebo|-12.0|STANDARD_ERROR_OF_MEAN|4.223|||TWO_SIDED|95.0|-20.3|-3.7||||||||-3.7|-20.3|
72600114|NCT00528372|144730115|SUPERIORITY_OR_OTHER||Difference from placebo|-16.2|STANDARD_ERROR_OF_MEAN|4.321|||TWO_SIDED|95.0|-24.7|-7.7||||||||-7.7|-24.7|
72600115|NCT00528372|144730115|SUPERIORITY_OR_OTHER||Difference from placebo|-17.9|STANDARD_ERROR_OF_MEAN|4.228|||TWO_SIDED|95.0|-26.2|-9.5||||||||-9.5|-26.2|
72600116|NCT00528372|144730117|SUPERIORITY_OR_OTHER||Percentage difference|9.7||||||||||||||||||
72600117|NCT00528372|144730117|SUPERIORITY_OR_OTHER||Percentage difference|12.6||||||||||||||||||
72600118|NCT00528372|144730117|SUPERIORITY_OR_OTHER||Percentage difference|19.2||||||||||||||||||
72600119|NCT00528372|144730117|SUPERIORITY_OR_OTHER||Percent difference from placebo|19.8|||||TWO_SIDED|95.0|4.9|34.7||||||||34.7|4.9|
72600120|NCT00528372|144730117|SUPERIORITY_OR_OTHER||Percent difference from placebo|12.4|||||TWO_SIDED|95.0|-2.5|27.3||||||||27.3|-2.5|
72600121|NCT00528372|144730117|SUPERIORITY_OR_OTHER||Percent difference from placebo|19.9|||||TWO_SIDED|95.0|5.3|34.5||||||||34.5|5.3|
72600122|NCT00528372|144730118|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.45|STANDARD_ERROR_OF_MEAN|0.6979||||||||||||||||
72600123|NCT00528372|144730118|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.19|STANDARD_ERROR_OF_MEAN|0.6828||||||||||||||||
72600124|NCT00528372|144730118|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.23|STANDARD_ERROR_OF_MEAN|0.6404||||||||||||||||
72600125|NCT00528372|144730118|SUPERIORITY_OR_OTHER||Difference from placebo|-1.55|STANDARD_ERROR_OF_MEAN|0.7394|||TWO_SIDED|95.0|-3.33|-0.42||||||||-0.42|-3.33|
72600126|NCT00528372|144730118|SUPERIORITY_OR_OTHER||Difference from placebo|-1.27|STANDARD_ERROR_OF_MEAN|0.7257|||TWO_SIDED|95.0|-2.69|0.16||||||||0.16|-2.69|
72600127|NCT00528372|144730118|SUPERIORITY_OR_OTHER||Difference from placebo|-0.87|STANDARD_ERROR_OF_MEAN|0.6103|||TWO_SIDED|95.0|-2.06|0.33||||||||0.33|-2.06|
72600128|NCT00528372|144730119|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.37|STANDARD_ERROR_OF_MEAN|0.175||||||||||||||||
72600129|NCT00528372|144730119|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.52|STANDARD_ERROR_OF_MEAN|0.175||||||||||||||||
72600130|NCT00528372|144730119|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.67|STANDARD_ERROR_OF_MEAN|0.1708||||||||||||||||
72600131|NCT00528372|144730119|SUPERIORITY_OR_OTHER||Difference from placebo|-0.6|STANDARD_ERROR_OF_MEAN|0.1798|||TWO_SIDED|95.0|-0.95|-0.25||||||||-0.25|-0.95|
72600132|NCT00528372|144730119|SUPERIORITY_OR_OTHER||Difference from placebo|-0.55|STANDARD_ERROR_OF_MEAN|0.1741|||TWO_SIDED|95.0|-0.89|-0.21||||||||-0.21|-0.89|
72600133|NCT00528372|144730119|SUPERIORITY_OR_OTHER||Difference from placebo|-0.58|STANDARD_ERROR_OF_MEAN|0.1704|||TWO_SIDED|95.0|-0.92|-0.25||||||||-0.25|-0.92|
72600134|NCT00528372|144730120|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.6|STANDARD_ERROR_OF_MEAN|6.526||||||||||||||||
72600135|NCT00528372|144730120|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.1|STANDARD_ERROR_OF_MEAN|6.761||||||||||||||||
72600136|NCT00528372|144730120|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.6|STANDARD_ERROR_OF_MEAN|6.334||||||||||||||||
72600137|NCT00528372|144730120|SUPERIORITY_OR_OTHER||Percent difference from placebo|18.8|||||TWO_SIDED|95.0|5.5|32.1||||||||32.1|5.5|
72600138|NCT00528372|144730120|SUPERIORITY_OR_OTHER||Percent difference from placebo|11.3|||||TWO_SIDED|95.0|-1.8|24.4||||||||24.4|-1.8|
72600139|NCT00528372|144730120|SUPERIORITY_OR_OTHER||Percent difference from placebo|11.4|||||TWO_SIDED|95.0|-1.0|23.9||||||||23.9|-1.0|
72600140|NCT00528372|144730121|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0|STANDARD_ERROR_OF_MEAN|0.736||||||||||||||||
72600141|NCT00528372|144730121|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.48|STANDARD_ERROR_OF_MEAN|0.7371||||||||||||||||
72600142|NCT00528372|144730121|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.96|STANDARD_ERROR_OF_MEAN|0.7078||||||||||||||||
72600143|NCT00528372|144730121|SUPERIORITY_OR_OTHER||Difference from placebo|-1.87|STANDARD_ERROR_OF_MEAN|0.7394|||TWO_SIDED|95.0|-3.33|-0.42||||||||-0.42|-3.33|
72600144|NCT00528372|144730121|SUPERIORITY_OR_OTHER||Difference from placebo|-1.27|STANDARD_ERROR_OF_MEAN|0.7257|||TWO_SIDED|95.0|-2.69|0.16||||||||0.16|-2.69|
72600145|NCT00528372|144730121|SUPERIORITY_OR_OTHER||Difference from placebo|-0.97|STANDARD_ERROR_OF_MEAN|0.7135||||95.0|-2.37|0.44||||||||0.44|-2.37|
72600146|NCT02774005|144730140|SUPERIORITY||Odds Ratio (OR)|2.286||||0.0021|TWO_SIDED|95.0|1.352|3.884|||Wald Chi-square|||||3.884|1.352|0.0021
72600147|NCT02774005|144730141|SUPERIORITY||Odds Ratio (OR)|1.646||||0.0873|TWO_SIDED|95.0|0.929|2.918|||Waldi-Chi-Square|||||2.918|0.929|0.0873
72600148|NCT02774005|144730142|SUPERIORITY||Odds Ratio (OR)|7.323||||0.0005|TWO_SIDED|95.0|2.339|25.912|||Waldi-Chi-Square|||||25.912|2.339|0.0005
72600149|NCT02379273|144730150|SUPERIORITY||||||<|0.001||||||The threshold for statistical significance was p = 0.05.|ANOVA|||A Friedman repeated-measures ANOVA on ranks was applied to the unilateral CNC data with follow-up pairwise comparisons based on the Tukey Test.||||<0.001
72600150|NCT02379273|144730150|SUPERIORITY|A Friedman repeated-measures ANOVA on ranks was applied to the bilateral CNC data with follow-up pairwise comparisons based on the Tukey Test.|||||<|0.001||||||The threshold for statistical significance was p = 0.05.|ANOVA|||||||<0.001
72600151|NCT02379273|144730151|SUPERIORITY|A Friedman repeated-measures ANOVA on ranks was applied to the unilateral AzBio data with follow-up pairwise comparisons based on the Tukey Test.|||||<|0.001||||||The threshold for statistical significance was p = 0.05.|ANOVA|||||||<0.001
72600152|NCT02379273|144730151|SUPERIORITY|A Friedman repeated-measures ANOVA on ranks was applied to the bilateral AzBio data with follow-up pairwise comparisons based on the Tukey Test.|||||<|0.001||||||The threshold for statistical significance was p = 0.05.|ANOVA|||||||<0.001
72600153|NCT02379273|144730152|SUPERIORITY|A one-way repeated-measures analysis of variance was applied to the data, with follow-up pairwise comparisons based on the Holm-Sidak method.|||||<|0.001||||||The threshold for statistical significance was p=0.05.|ANOVA|||||||<0.001
72600154|NCT02379273|144730153|SUPERIORITY|A one-way repeated-measures analysis of variance was applied to the data, with follow-up pairwise comparisons based on the Holm-Sidak method.|||||<|0.001|||||||ANOVA|The threshold for statistical significance was p=0.05.||||||<0.001
72600155|NCT02379273|144730154|SUPERIORITY|Pre- and postoperative mean scores were compared based on Friedman repeated-measures analysis of variance with follow-up pairwise comparisons based on the Tukey Test.|||||<|0.001||||||The threshold for statistical significance was p=0.05.|ANOVA|||||||<0.001
72415989|NCT02962908|144342789|OTHER|||||||0.662|||||||Fisher Exact|||Differences in the infection rates against any of the strains tested between treatment group and corresponding placebo.||||0.662
72600156|NCT03275389|144730194|EQUIVALENCE|The use of the adjuvant (AS03) is to be considered justified if the lower limit of the 94.46% CI of the GMC ratio (adjuvanted vs non-adjuvanted) is \> 1.50|GMC ratio|2.47|||||TWO_SIDED|94.46|2.06|2.95|||Dunnett's t test|Comparison performed using a 2-sided alpha=0.1 and Dunnett adjustment for multiple comparisons,||To evaluate the adjuvant effect of AS03 (Pooling of results at Day 29 of D-SUIV Adjuvant Group 1, at Day 29 of D-SUIV Adjuvant Group 2 and Day 85 of D-SUIV Adjuvant Group 3) on the humoral immune response for anti-H1 stalk antibody by ELISA at Day 29 and Day 85 (i.e. 28 days post-vaccination) when compared to the non-adjuvanted formulations (Pooling of results at Day 29 of D-SUIV Unadjuvanted Group 1, at Day 29 of D-SUIV Unadjuvanted Group 2 and Day 85 of D-SUIV Unadjuvanted Group 3).||2.95|2.06|
72600157|NCT03275389|144730194|EQUIVALENCE|The use of the adjuvant (AS01) is to be considered justified if the lower limit of the 94.46% CI of the GMC ratio (adjuvanted vs non-adjuvanted) is \> 1.50|GMC ratio|1.75|||||TWO_SIDED|94.46|1.46|2.1|||Dunnett's t test|Comparison performed using a 2-sided alpha=0.1 and Dunnett adjustment for multiple comparisons,||To evaluate the adjuvant effect of AS01 (Pooling of results at Day 29 of D-SUIV Adjuvant Group 4, at Day 29 of D-SUIV Adjuvant Group 5 and Day 85 of D-SUIV Adjuvant Group 6) on the humoral immune response for anti-H1 stalk antibody by ELISA at Day 29 and Day 85 (i.e. 28 days post-vaccination) when compared to the non-adjuvanted formulations (Pooling of results at Day 29 of D-SUIV Unadjuvanted Group 1, at Day 29 of D-SUIV Unadjuvanted Group 2 and Day 85 of D-SUIV Unadjuvanted Group 3).||2.1|1.46|
72600158|NCT02432144|144730211|SUPERIORITY||LS Mean|-62.28|STANDARD_ERROR_OF_MEAN|4.946|<|0.0001|TWO_SIDED|95.0|-71.98|-52.59||P-values are from generalized estimating equation (GEE) model including baseline value and visit (in this study) as a categorical variable. The covariance structure within subjects is assumed to be exchangeable.|GEE model|||Week 0||-52.59|-71.98|< 0.0001
72600159|NCT02432144|144730211|SUPERIORITY||LS Mean|-67.18|STANDARD_ERROR_OF_MEAN|3.224|<|0.0001|TWO_SIDED|95.0|-73.49|-60.86||P-values are from a GEE model including baseline value and visit (in this study) as a categorical variable. The covariance structure within subjects is assumed to be exchangeable.|GEE model|||Week 12||-60.86|-73.49|< 0.0001
72600160|NCT02432144|144730211|SUPERIORITY||LS Mean|-64.12|STANDARD_ERROR_OF_MEAN|4.016|<|0.0001|TWO_SIDED|95.0|-71.99|-56.24||P-values are from a GEE model including baseline value and visit (in this study) as a categorical variable. The covariance structure within subjects is assumed to be exchangeable.|GEE model|||Week 24||-56.24|-71.99|< 0.0001
72600161|NCT02432144|144730211|SUPERIORITY||LS Mean|-60.8|STANDARD_ERROR_OF_MEAN|5.992|<|0.0001|TWO_SIDED|95.0|-72.54|-49.06||P-values are from a GEE model including baseline value and visit (in this study) as a categorical variable. The covariance structure within subjects is assumed to be exchangeable.|GEE model|||Week 36||-49.06|-72.54|< 0.0001
72600162|NCT02432144|144730211|SUPERIORITY||LS Mean|-57.85|||<|0.0001|TWO_SIDED|95.0|-71.87|-43.82||P-values are from a GEE model including baseline value and visit (in this study) as a categorical variable. The covariance structure within subjects is assumed to be exchangeable.|GEE model|||Week 48||-43.82|-71.87|< 0.0001
72600163|NCT00978341|144730212|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|0.462||0.6797||95.0|-0.83|1.22|||ANOVA|||Difference from placebo (including Baseline), Day 1: 0.5 hours post-dose.||1.22|-0.83|0.6797
72600164|NCT00978341|144730212|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.38|STANDARD_ERROR_OF_MEAN|0.528||0.4811||95.0|-1.54|0.77|||ANOVA|||Difference from placebo (including Baseline), Day 1: 1 hour post-dose.||0.77|-1.54|0.4811
72600165|NCT00978341|144730212|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.67|STANDARD_ERROR_OF_MEAN|0.454||0.1693||95.0|-1.67|0.33|||ANOVA|||Difference from placebo (including Baseline), Day 1: 2 hours post-dose.||0.33|-1.67|0.1693
72600166|NCT00978341|144730212|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.45|STANDARD_ERROR_OF_MEAN|0.487||0.4034||95.0|-1.78|0.87|||ANOVA|||Difference from placebo (including Baseline) , Day 1: 3 hours post-dose.||0.87|-1.78|0.4034
72600167|NCT00978341|144730212|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.93|STANDARD_ERROR_OF_MEAN|0.694||0.1935||95.0|-2.36|0.5|||ANOVA|||Difference from placebo (including Baseline), Day 1: 4 hours post-dose.||0.50|-2.36|0.1935
72600168|NCT00978341|144730212|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.36|STANDARD_ERROR_OF_MEAN|0.715||0.0694||95.0|-2.83|0.12|||ANOVA|||Difference from placebo (including Baseline), Day 1: 5 hours post-dose.||0.12|-2.83|0.0694
72600169|NCT00978341|144730212|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.55|STANDARD_ERROR_OF_MEAN|0.713||0.0396||95.0|-3.02|-0.08|||ANOVA|||Difference from placebo (including Baseline), Day 1: 6 hours post-dose.||-0.08|-3.02|0.0396
72600170|NCT00978341|144730212|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.51|STANDARD_ERROR_OF_MEAN|0.319||0.1531||95.0|-1.25|0.24|||ANOVA|||Difference from placebo (including Baseline), Day 1: 8 hours post-dose.||0.24|-1.25|0.1531
72600171|NCT00978341|144730212|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.25|STANDARD_ERROR_OF_MEAN|0.637||0.0951||95.0|-2.79|0.29|||ANOVA|||Difference from placebo (including Baseline), Day 1: 10 hours post-dose.||0.29|-2.79|0.0951
72600172|NCT00978341|144730212|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.38|STANDARD_ERROR_OF_MEAN|0.615||0.0614||95.0|-2.84|0.09|||ANOVA|||Difference from placebo (including Baseline), Day 1: 12 hours post-dose.||0.09|-2.84|0.0614
72600173|NCT00978341|144730212|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.87|STANDARD_ERROR_OF_MEAN|0.619||0.1946||95.0|-2.29|0.54|||ANOVA|||Difference from placebo (including Baseline), Day 8: pre-dose.||0.54|-2.29|0.1946
72600174|NCT00978341|144730212|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.68|STANDARD_ERROR_OF_MEAN|0.553||0.2843||95.0|-2.2|0.84|||ANOVA|||Difference from placebo (including Baseline), Day 8: 0.5 hours post-dose.||0.84|-2.20|0.2843
72600175|NCT00978341|144730212|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.05|STANDARD_ERROR_OF_MEAN|0.82||0.215||95.0|-2.75|0.65|||ANOVA|||Difference from placebo (including Baseline), Day 8: 1 hour post-dose.||0.65|-2.75|0.2150
72600176|NCT00978341|144730212|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.189||0.9601||95.0|-0.44|0.42|||ANOVA|||Difference from placebo (including Baseline), Day 8: 2 hours post-dose.||0.42|-0.44|0.9601
72600177|NCT00978341|144730212|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.311||0.867||95.0|-0.64|0.74|||ANOVA|||Difference from placebo (including baseline), Day 8: 3 hours post-dose.||0.74|-0.64|0.8670
72600178|NCT00978341|144730212|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.393||0.9024||95.0|-0.94|0.84|||ANOVA|||Difference from placebo (including baseline), Day 8: 4 hours post-dose.||0.84|-0.94|0.9024
72600179|NCT00978341|144730212|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.293||0.9708||95.0|-0.67|0.65|||ANOVA|||Difference from placebo (including Baseline), Day 8: 5 hours post-dose.||0.65|-0.67|0.9708
72600180|NCT00978341|144730212|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.71|STANDARD_ERROR_OF_MEAN|0.395||0.1078||95.0|-1.62|0.19|||ANOVA|||Difference from placebo (including Baseline), Day 8: 6 hours post-dose.||0.19|-1.62|0.1078
72600181|NCT00978341|144730212|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.33|STANDARD_ERROR_OF_MEAN|0.419||0.446||95.0|-1.28|0.61|||ANOVA|||Difference from placebo (including Baseline), Day 8: 8 hours post-dose.||0.61|-1.28|0.4460
72600182|NCT00978341|144730212|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.26|STANDARD_ERROR_OF_MEAN|0.394||0.5266||95.0|-1.13|0.62|||ANOVA|||Difference from placebo (including Baseline), Day 8: 10 hours post-dose.||0.62|-1.13|0.5266
72600183|NCT00978341|144730212|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.69|STANDARD_ERROR_OF_MEAN|0.273||0.029||95.0|-1.29|-0.08|||ANOVA|||Difference from placebo (including Baseline), Day 8: 12 hours post-dose.||-0.08|-1.29|0.0290
72600184|NCT00978341|144730212|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.78|STANDARD_ERROR_OF_MEAN|0.531||0.183||95.0|-2.01|0.45|||ANOVA|||Difference from placebo (including Baseline), Day 8: 24 hours post-dose.||0.45|-2.01|0.1830
72600185|NCT00978341|144730212|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.406||0.9884||95.0|-0.9|0.91|||ANOVA|||Difference from placebo (including Baseline), Day 8: 36 hours post-dose.||0.91|-0.90|0.9884
72600186|NCT00978341|144730212|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.09|STANDARD_ERROR_OF_MEAN|0.354||0.8082||95.0|-0.87|0.69|||ANOVA|||Difference from placebo (including Baseline), Day 8: 48 hours post-dose.||0.69|-0.87|0.8082
72600187|NCT00978341|144730213|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.92|STANDARD_ERROR_OF_MEAN|0.714||0.2101||95.0|-2.39|0.55|||ANOVA|||Difference from placebo (including baseline); Day 2. Combined analysis: values for the two patient groups were analyzed together using ANOVA and/or mixed models.||0.55|-2.39|0.2101
72600188|NCT00978341|144730213|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.04|STANDARD_ERROR_OF_MEAN|0.623||0.1065||95.0|-2.33|0.24|||ANOVA|||Difference from placebo (including baseline); Day 3.||0.24|-2.33|0.1065
72600189|NCT00978341|144730213|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.53|STANDARD_ERROR_OF_MEAN|0.254||0.0697||95.0|-1.11|0.05|||ANOVA|||Difference from placebo (including baseline); Day 4.||0.05|-1.11|0.0697
72600190|NCT00978341|144730213|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.49|STANDARD_ERROR_OF_MEAN|0.65||0.4589||95.0|-1.83|0.85|||ANOVA|||Difference from placebo; Day 5.||0.85|-1.83|0.4589
72600191|NCT00978341|144730213|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.16|STANDARD_ERROR_OF_MEAN|0.742||0.1326||95.0|-2.69|0.38|||ANOVA|||Difference from placebo; Day 6.||0.38|-2.69|0.1326
72600192|NCT00978341|144730213|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.78|STANDARD_ERROR_OF_MEAN|0.638||0.282||95.0|-2.45|0.9|||ANOVA|||Difference from placebo (including baseline); Day 7.||0.90|-2.45|0.2820
72600193|NCT00978341|144730213|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.33|STANDARD_ERROR_OF_MEAN|0.356||0.0108||95.0|-2.21|-0.44|||ANOVA|||Difference from placebo (including baseline); Day 8.||-0.44|-2.21|0.0108
72600194|NCT00978341|144730214|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.26|STANDARD_ERROR_OF_MEAN|19.06||0.9068||95.0|-41.78|37.27|||ANOVA|||Difference from placebo; Day 1: 4 hours post-dose (including Baseline).||37.27|-41.78|0.9068
72600195|NCT00978341|144730214|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.52|STANDARD_ERROR_OF_MEAN|15.813||0.7807||95.0|-30.53|39.57|||ANOVA|||Difference from placebo; Day 8: pre-dose (including Baseline).||39.57|-30.53|0.7807
72600196|NCT00978341|144730214|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-22.51|STANDARD_ERROR_OF_MEAN|17.526||0.2293||95.0|-61.79|16.78|||ANOVA|||Difference from placebo; Day 8: 4 hours post-dose (including Baseline).||16.78|-61.79|0.2293
72600197|NCT00978341|144730215|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.36|STANDARD_ERROR_OF_MEAN|0.386||0.3774||95.0|-0.54|1.27|||ANOVA|||Difference from placebo (including Baseline); Day 1: 0.5 hours post-dose.||1.27|-0.54|0.3774
72600198|NCT00978341|144730215|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.19|STANDARD_ERROR_OF_MEAN|0.215||0.4153||95.0|-0.33|0.7|||ANOVA|||Difference from placebo (including Baseline); Day 1: 1 hour post-dose.||0.70|-0.33|0.4153
72600199|NCT00978341|144730215|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.48||||0.147||95.0|-0.23|1.2|||ANOVA|||Difference from placebo (including Baseline); Day 1: 2 hours post-dose.||1.20|-0.23|0.1470
72600200|NCT00978341|144730215|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.45|STANDARD_ERROR_OF_MEAN|0.3||0.1862||95.0|-1.18|0.29|||ANOVA|||Difference from placebo (including Baseline); Day 1: 3 hours post-dose.||0.29|-1.18|0.1862
72600201|NCT00978341|144730215|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.22||0.8321||95.0|-0.45|0.55|||ANOVA|||Difference from placebo (including Baseline); Day 1: 4 hours post-dose.||0.55|-0.45|0.8321
72600202|NCT00978341|144730215|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.23|STANDARD_ERROR_OF_MEAN|0.269||0.4251||95.0|-0.42|0.88|||ANOVA|||Difference from placebo (including Baseline); Day 1: 5 hours post-dose.||0.88|-0.42|0.4251
72600203|NCT00978341|144730215|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.13|STANDARD_ERROR_OF_MEAN|0.269||0.6394||95.0|-0.53|0.8|||ANOVA|||Difference from placebo (including Baseline); Day 1: 6 hours post-dose.||0.80|-0.53|0.6394
72600204|NCT00978341|144730215|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.302||0.9964||95.0|-0.68|0.68|||ANOVA|||Difference from placebo (including Baseline); Day 8: pre-dose.||0.68|-0.68|0.9964
72600205|NCT00978341|144730215|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.32|STANDARD_ERROR_OF_MEAN|0.324||0.3638||95.0|-0.47|1.11|||ANOVA|||Difference from placebo (including Baseline); Day 8: 0.5 hours post-dose.||1.11|-0.47|0.3638
72600206|NCT00978341|144730215|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.42|STANDARD_ERROR_OF_MEAN|0.223||0.1202||95.0|-0.15|0.99|||ANOVA|||Difference from placebo (including Baseline); Day 8: 1 hour post-dose.||0.99|-0.15|0.1202
72600207|NCT00978341|144730215|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.6|STANDARD_ERROR_OF_MEAN|0.355||0.1204||95.0|-0.19|1.39|||ANOVA|||Difference from placebo (including Baseline); Day 8: 2 hours post-dose.||1.39|-0.19|0.1204
72600208|NCT00978341|144730215|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.25|STANDARD_ERROR_OF_MEAN|0.289||0.4213||95.0|-0.44|0.93|||ANOVA|||Difference from placebo (including Baseline); Day 8: 3 hours post-dose.||0.93|-0.44|0.4213
72600209|NCT00978341|144730215|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.11|STANDARD_ERROR_OF_MEAN|0.205||0.6028||95.0|-0.34|0.56|||ANOVA|||Difference from placebo (including Baseline); Day 8: 4 hours post-dose.||0.56|-0.34|0.6028
72600210|NCT00978341|144730215|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.48|STANDARD_ERROR_OF_MEAN|0.491||0.3624||95.0|-0.68|1.64|||ANOVA|||Difference from placebo (including Baseline); Day 8: 5 hours post-dose.||1.64|-0.68|0.3624
72600211|NCT00978341|144730215|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.48|STANDARD_ERROR_OF_MEAN|0.461||0.3163||95.0|-0.52|1.49|||ANOVA|||Difference from placebo (including Baseline); Day 8: 6 hours post-dose.||1.49|-0.52|0.3163
72600212|NCT00978341|144730216|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.39|STANDARD_ERROR_OF_MEAN|9.738||0.5919||95.0|-16.26|27.04|||ANOVA|||Difference from placebo (including Baseline); Day 1.||27.04|-16.26|0.5919
72600213|NCT00978341|144730216|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|12.58|STANDARD_ERROR_OF_MEAN|14.603||0.3981||95.0|-17.7|42.87|||ANOVA|||Difference from placebo (including Baseline); Day 8: pre-dose.||42.87|-17.70|0.3981
72600214|NCT00978341|144730216|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.64|STANDARD_ERROR_OF_MEAN|12.123||0.8314||95.0|-24.0|29.28|||ANOVA|||Difference from placebo (including Baseline); Day 8: 4 hours post-dose.||29.28|-24.00|0.8314
72600215|NCT00978341|144730217|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.054||0.7569||95.0|-0.14|0.1|||ANOVA|||Difference from placebo (including Baseline); Day 1: 2 hours post-dose.||0.10|-0.14|0.7569
72600216|NCT00978341|144730217|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.07|STANDARD_ERROR_OF_MEAN|0.09||0.4814||95.0|-0.26|0.13|||ANOVA|||Difference from placebo (including Baseline); Day 1: 4 hours post-dose.||0.13|-0.26|0.4814
72600217|NCT00978341|144730217|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.07|STANDARD_ERROR_OF_MEAN|0.143||0.6222||95.0|-0.37|0.23|||ANOVA|||Difference from placebo (including Baseline); Day 1: 6 hours post-dose.||0.23|-0.37|0.6222
72600218|NCT00978341|144730217|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.12|STANDARD_ERROR_OF_MEAN|0.113||0.3035||95.0|-0.35|0.12|||ANOVA|||Difference from placebo (including Baseline); Day 8: pre-dose.||0.12|-0.35|0.3035
72600219|NCT00978341|144730217|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.17|STANDARD_ERROR_OF_MEAN|0.122||0.1881||95.0|-0.42|0.09|||ANOVA|||Difference from placebo (including Baseline); Day 8: 2 hours post-dose.||0.09|-0.42|0.1881
72600220|NCT00978341|144730217|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.08|STANDARD_ERROR_OF_MEAN|0.072||0.3159||95.0|-0.09|0.24|||ANOVA|||Difference from placebo (including Baseline); Day 8: 4 hours post-dose.||0.24|-0.09|0.3159
72600221|NCT00978341|144730217|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.103||0.8203||95.0|-0.22|0.27|||ANOVA|||Difference from placebo (including Baseline); Day 8: 6 hours post-dose.||0.27|-0.22|0.8203
72600222|NCT03035916|144730220|OTHER|||||||0.454|||||||t-test, 2 sided|||"The plasma level of norepinephrine(NE) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control. This Statistical Analysis applied to Baseline row."||||0.454
72600223|NCT03035916|144730220|OTHER|||||||0.402|||||||t-test, 2 sided|||"The plasma level of norepinephrine(NE) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control. This Statistical Analysis applied to Baseline row."||||0.402
72600224|NCT03035916|144730220|OTHER|||||||0.901|||||||t-test, 2 sided|||"The plasma level of norepinephrine(NE) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control. This Statistical Analysis applied to Baseline row."||||0.901
72600225|NCT03035916|144730220|OTHER|||||||0.54|||||||t-test, 2 sided|||"The plasma level of norepinephrine(NE) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control. This Statistical Analysis applied to 0 hour after surgery row."||||0.540
72600226|NCT03035916|144730220|OTHER|||||||0.523|||||||t-test, 2 sided|||"The plasma level of norepinephrine(NE) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control. This Statistical Analysis applied to 0 hour after surgery row."||||0.523
72600227|NCT03035916|144730220|OTHER|||||||0.26|||||||t-test, 2 sided|||"The plasma level of norepinephrine(NE) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control. This Statistical Analysis applied to 0 hour after surgery row."||||0.260
72600228|NCT03035916|144730220|OTHER|||||||0.139|||||||t-test, 2 sided|||"The plasma level of norepinephrine(NE) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control. This Statistical Analysis applied to 6 hours after surgery row."||||0.139
72600229|NCT03035916|144730220|OTHER|||||||0.001|||||||t-test, 2 sided|||"The plasma level of norepinephrine(NE) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control. This Statistical Analysis applied to 6 hours after surgery row."||||0.001
72600230|NCT03035916|144730220|OTHER|||||||0.001|||||||t-test, 2 sided|||"The plasma level of norepinephrine(NE) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control. This Statistical Analysis applied to 6 hours after surgery row."||||0.001
72600231|NCT03035916|144730220|OTHER|||||||0.464|||||||t-test, 2 sided|||"The plasma level of norepinephrine(NE) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control. This Statistical Analysis applied to 24 hours after surgery row."||||0.464
72600232|NCT03035916|144730220|OTHER|||||||0.007|||||||t-test, 2 sided|||"The plasma level of norepinephrine(NE) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control. This Statistical Analysis applied to 24 hours after surgery row."||||0.007
72415990|NCT02962908|144342789|OTHER|||||||0.168|||||||Fisher Exact|||Differences in the infection rates against any of the strains tested between treatment group and corresponding placebo.||||0.168
72600233|NCT03035916|144730220|OTHER|||||||0.001|||||||t-test, 2 sided|||"The plasma level of norepinephrine(NE) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control. This Statistical Analysis applied to 24 hours after surgery row."||||0.001
72600234|NCT03035916|144730220|OTHER|||||||0.411|||||||t-test, 2 sided|||"The plasma level of norepinephrine(NE) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control. This Statistical Analysis applied to 48 hours after surgery row."||||0.411
72600235|NCT03035916|144730220|OTHER|||||||0.001|||||||t-test, 2 sided|||"The plasma level of norepinephrine(NE) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control. This Statistical Analysis applied to 48 hours after surgery row."||||0.001
72600236|NCT03035916|144730220|OTHER|||||||0.001|||||||t-test, 2 sided|||"The plasma level of norepinephrine(NE) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control. This Statistical Analysis applied to 48 hours after surgery row."||||0.001
72600237|NCT03035916|144730221|OTHER|||||||0.412|||||||t-test, 2 sided|||"The plasma level of epinephrine (E) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control. This Statistical Analysis applied to Baseline row."||||0.412
72600238|NCT03035916|144730221|OTHER|||||||0.592|||||||t-test, 2 sided|||"The plasma level of epinephrine (E) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control. This Statistical Analysis applied to Baseline row."||||0.592
72600239|NCT03035916|144730221|OTHER|||||||0.796|||||||t-test, 2 sided|||"The plasma level of epinephrine (E) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control. This Statistical Analysis applied to Baseline row."||||0.796
72600240|NCT03035916|144730221|OTHER|||||||0.576|||||||t-test, 2 sided|||"The plasma level of epinephrine (E) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control. This Statistical Analysis applied to 0 hour after surgery row."||||0.576
72600241|NCT03035916|144730221|OTHER|||||||0.427|||||||t-test, 2 sided|||"The plasma level of epinephrine (E) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control. This Statistical Analysis applied to 0 hour after surgery row."||||0.427
72600242|NCT03035916|144730221|OTHER|||||||0.201|||||||t-test, 2 sided|||"The plasma level of epinephrine (E) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control. This Statistical Analysis applied to 0 hour after surgery row."||||0.201
72600243|NCT03035916|144730221|OTHER|||||||0.872|||||||t-test, 2 sided|||"The plasma level of epinephrine (E) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control. This Statistical Analysis applied to 6 hours after surgery row."||||0.872
72600244|NCT03035916|144730221|OTHER|||||||0.001|||||||t-test, 2 sided|||"The plasma level of epinephrine (E) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control. This Statistical Analysis applied to 6 hours after surgery row."||||0.001
72600245|NCT03035916|144730221|OTHER|||||||0.001|||||||t-test, 2 sided|||"The plasma level of epinephrine (E) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control. This Statistical Analysis applied to 6 hours after surgery row."||||0.001
72600246|NCT03035916|144730221|OTHER|||||||0.165|||||||t-test, 2 sided|||"The plasma level of epinephrine (E) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control. This Statistical Analysis applied to 24 hours after surgery row."||||0.165
72600247|NCT03035916|144730221|OTHER|||||||0.001|||||||t-test, 2 sided|||"The plasma level of epinephrine (E) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control. This Statistical Analysis applied to 24 hours after surgery row."||||0.001
72600248|NCT03035916|144730221|OTHER|||||||0.001|||||||t-test, 2 sided|||"The plasma level of epinephrine (E) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control. This Statistical Analysis applied to 24 hours after surgery row."||||0.001
72600249|NCT03035916|144730221|OTHER|||||||0.305|||||||t-test, 2 sided|||"The plasma level of epinephrine (E) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control. This Statistical Analysis applied to 48 hours after surgery row."||||0.305
72600250|NCT03035916|144730221|OTHER|||||||0.001|||||||t-test, 2 sided|||"The plasma level of epinephrine (E) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control. This Statistical Analysis applied to 48 hours after surgery row."||||0.001
72415991|NCT02962908|144342790|OTHER||||||>|0.05|||||||Wilcoxon (Mann-Whitney)||||The study was not powered to detected statistical significant differences in this outcome.|||>0.05
72415992|NCT02962908|144342790|OTHER||||||>|0.05|||||||Wilcoxon (Mann-Whitney)||||Study not powered to detect statistically significant differences|||>0.05
72415993|NCT02962908|144342791|OTHER|||||||0.513|||||||Wilcoxon (Mann-Whitney)|||Comparison in the duration of symptoms between treatment group and corresponding placebo.||||0.513
72415994|NCT02962908|144342791|OTHER|||||||0.578|||||||Wilcoxon (Mann-Whitney)|||Comparison of the duration of symptoms between treatment group and corresponding placebo.||||0.578
72415995|NCT02962908|144342791|OTHER|||||||0.513|||||||Wilcoxon (Mann-Whitney)|||Comparison of total symptom score between treatment group and corresponding placebo.||||0.513
72600251|NCT03035916|144730221|OTHER|||||||0.001|||||||t-test, 2 sided|||"The plasma level of epinephrine (E) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control. This Statistical Analysis applied to 48 hours after surgery row."||||0.001
72600252|NCT03035916|144730222|OTHER|||||||0.673|||||||t-test, 2 sided|||"The plasma level of cortisol (Cor) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to Baseline row."||||0.673
72600253|NCT03035916|144730222|OTHER|||||||0.824|||||||t-test, 2 sided|||"The plasma level of cortisol (Cor) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to Baseline row."||||0.824
72600254|NCT03035916|144730222|OTHER|||||||0.547|||||||t-test, 2 sided|||"The plasma level of cortisol (Cor) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to Baseline row."||||0.547
72600255|NCT03035916|144730222|OTHER|||||||0.303|||||||t-test, 2 sided|||"The plasma level of cortisol (Cor) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to 0 hour after surgery row."||||0.303
72600256|NCT03035916|144730222|OTHER|||||||0.026|||||||t-test, 2 sided|||"The plasma level of cortisol (Cor) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to 0 hour after surgery row."||||0.026
72600257|NCT03035916|144730222|OTHER|||||||0.002|||||||t-test, 2 sided|||"The plasma level of cortisol (Cor) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to 0 hour after surgery row."||||0.002
72600258|NCT03035916|144730222|OTHER|||||||0.057|||||||t-test, 2 sided|||"The plasma level of cortisol (Cor) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to 6 hours after surgery row."||||0.057
72600259|NCT03035916|144730222|OTHER|||||||0.001|||||||t-test, 2 sided|||"The plasma level of cortisol (Cor) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to 6 hours after surgery row."||||0.001
72600260|NCT03035916|144730222|OTHER|||||||0.001|||||||t-test, 2 sided|||"The plasma level of cortisol (Cor) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to 6 hours after surgery row."||||0.001
72600261|NCT03035916|144730222|OTHER|||||||0.069|||||||t-test, 2 sided|||"The plasma level of cortisol (Cor) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to 24 hours after surgery row."||||0.069
72600262|NCT03035916|144730222|OTHER|||||||0.001|||||||t-test, 2 sided|||"The plasma level of cortisol (Cor) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to 24 hours after surgery row."||||0.001
72600263|NCT03035916|144730222|OTHER|||||||0.001|||||||t-test, 2 sided|||"The plasma level of cortisol (Cor) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to 24 hours after surgery row."||||0.001
72600264|NCT03035916|144730222|OTHER|||||||0.561|||||||t-test, 2 sided|||"The plasma level of cortisol (Cor) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to 48 hours after surgery row."||||0.561
72600265|NCT03035916|144730222|OTHER|||||||0.001|||||||t-test, 2 sided|||"The plasma level of cortisol (Cor) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to 48 hours after surgery row."||||0.001
72600266|NCT03035916|144730222|OTHER|||||||0.001|||||||t-test, 2 sided|||"The plasma level of cortisol (Cor) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to 48 hours after surgery row."||||0.001
72600267|NCT03035916|144730223|OTHER|||||||0.249|||||||t-test, 2 sided|||"The plasma level of glucose (Glu) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to Baseline row."||||0.249
72415996|NCT02962908|144342791|OTHER|||||||0.2|||||||Wilcoxon (Mann-Whitney)|||Comparison of the total symptom score between treatment group and corresponding placebo.||||0.200
72415997|NCT02962908|144342791|OTHER|||||||0.658|||||||Wilcoxon (Mann-Whitney)|||Comparison of the symptom peak between treatment group and corresponding placebo.||||0.658
72415998|NCT02962908|144342791|OTHER|||||||0.64|||||||Wilcoxon (Mann-Whitney)|||Comparison of the symptom peak between treatment group and corresponding placebo.||||0.640
72415999|NCT02962908|144342791|OTHER|||||||0.127|||||||Wilcoxon (Mann-Whitney)|||Comparison of the average symptom score between treatment group and corresponding placebo.||||0.127
72416000|NCT02962908|144342791|OTHER|||||||0.201|||||||Wilcoxon (Mann-Whitney)|||Comparison of the average symptom score between treatment group and corresponding placebo.||||0.201
72416001|NCT02962908|144342792|OTHER|inequality test||||||0.85|||||||Chi-squared|||comparison between groups on day 42||||0.85
72416002|NCT02962908|144342792|OTHER|inequality test||||||0.042|||||||Fisher Exact|||comparison between groups on day 42||||0.042
72416003|NCT02962908|144342792|OTHER|inequality test||||||0.69|||||||Fisher Exact|||comparison between groups on day 180||||0.69
72600268|NCT03035916|144730223|OTHER|||||||0.091|||||||t-test, 2 sided|||"The plasma level of glucose (Glu) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to Baseline row."||||0.091
72416004|NCT02962908|144342792|OTHER|inequality test||||||0.198|||||||Fisher Exact|||comparison between groups on day 180||||0.198
72600269|NCT03035916|144730223|OTHER|||||||0.493|||||||t-test, 2 sided|||"The plasma level of glucose (Glu) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to Baseline row."||||0.493
72600270|NCT03035916|144730223|OTHER|||||||0.067|||||||t-test, 2 sided|||"The plasma level of glucose (Glu) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to 0 hour after surgery row."||||0.067
72416005|NCT02962908|144342792|OTHER|inequality test||||||0.092|||||||Chi-squared|||comparison between groups on day 42||||0.092
72416006|NCT02962908|144342792|OTHER|inequality test|||||<|0.001|||||||Chi-squared|||comparison of groups on day 42||||<0.001
72416007|NCT02962908|144342792|OTHER|inequality test||||||0.27|||||||Chi-squared|||comparison of groups on day 180||||0.27
72416008|NCT02962908|144342792|OTHER|inequality test|||||<|0.001|||||||Chi-squared|||comparisons between groups on day 180||||<0.001
72416009|NCT02477618|144342811|SUPERIORITY||Odds Ratio (OR)|1.056||||0.878|TWO_SIDED|95.0|0.527|2.118|||Regression, Logistic|||||2.118|0.527|0.878
72416010|NCT02477618|144342812|SUPERIORITY||Hazard Ratio (HR)|0.747||||0.636|TWO_SIDED|95.0|0.222|2.507|||Regression, Cox|||||2.507|0.222|0.636
72416011|NCT02477618|144342813|SUPERIORITY||Odds Ratio (OR)|0.623||||0.199|TWO_SIDED|95.0|0.303|1.282|||Regression, Logistic|||||1.282|0.303|0.199
72416012|NCT02477618|144342814|SUPERIORITY||Hazard Ratio (HR)|0.683||||0.328|TWO_SIDED|95.0|0.318|1.466|||Regression, Cox|||||1.466|0.318|0.328
72416013|NCT02477618|144342816|SUPERIORITY||Hazard Ratio (HR)|0.583||||0.339|TWO_SIDED|95.0|0.193|1.763|||Regression, Cox|||||1.763|0.193|0.339
72416014|NCT02477618|144342817|SUPERIORITY||Hazard Ratio (HR)|1.086||||0.817|TWO_SIDED|95.0|0.539|2.189|||Regression, Cox|||||2.189|0.539|0.817
72416015|NCT02477618|144342818|SUPERIORITY||LS Mean Difference|-0.2||||0.567|TWO_SIDED|95.0|-0.9|0.5|||ANCOVA|||||0.5|-0.9|0.567
72416016|NCT05540522|144342835|OTHER||RVE|34.5|||||TWO_SIDED|95.0|7.4|53.9||||||||53.9|7.4|
72416017|NCT05540522|144342836|OTHER||RVE|-5.8|||||TWO_SIDED|95.0|-47.2|23.8||||||||23.8|-47.2|
72416018|NCT05540522|144342857|OTHER||GMR|1.23|||||TWO_SIDED|95.0|1.1|1.38||||||A/H3N2||1.38|1.10|
72416019|NCT05540522|144342857|OTHER||GMR|1.24|||||TWO_SIDED|95.0|1.1|1.39||||||A/H1N1||1.39|1.10|
72416020|NCT05540522|144342857|OTHER||GMR|0.73|||||TWO_SIDED|95.0|0.67|0.8||||||B/Yamagata||0.80|0.67|
72416021|NCT05540522|144342857|OTHER||GMR|0.3|||||TWO_SIDED|95.0|0.26|0.35||||||B/Victoria||0.35|0.26|
72416022|NCT05540522|144342858|OTHER||GMR|1.65|||||TWO_SIDED|95.0|1.47|1.84||||||A/H3N2||1.84|1.47|
72416023|NCT05540522|144342858|OTHER||GMR|1.71|||||TWO_SIDED|95.0|1.51|1.92||||||A/H1N1||1.92|1.51|
72416024|NCT05540522|144342858|OTHER||GMR|1.04|||||TWO_SIDED|95.0|0.95|1.14||||||B/Yamagata||1.14|0.95|
72416025|NCT05540522|144342858|OTHER||GMR|0.61|||||TWO_SIDED|95.0|0.54|0.69||||||B/Victoria||0.69|0.54|
72416026|NCT05540522|144342859|OTHER||Difference in percentage|11.4|||||TWO_SIDED|95.0|6.4|16.4||||||A/H3N2: 2-Sided CI, difference in percents (qIRV - Licensed QIV), expressed as a percentage.||16.4|6.4|
72600271|NCT03035916|144730223|OTHER|||||||0.001|||||||t-test, 2 sided|||"The plasma level of glucose (Glu) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to 0 hour after surgery row."||||0.001
72600272|NCT03035916|144730223|OTHER|||||||0.001|||||||t-test, 2 sided|||"The plasma level of glucose (Glu) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to 0 hour after surgery row."||||0.001
72600273|NCT03035916|144730223|OTHER|||||||0.079|||||||t-test, 2 sided|||"The plasma level of glucose (Glu) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to 6 hours after surgery row."||||0.079
72600274|NCT03035916|144730223|OTHER|||||||0.001|||||||t-test, 2 sided|||"The plasma level of glucose (Glu) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to 6 hours after surgery row."||||0.001
72600275|NCT03035916|144730223|OTHER|||||||0.001|||||||t-test, 2 sided|||"The plasma level of glucose (Glu) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to 6 hours after surgery row."||||0.001
72416027|NCT05540522|144342859|OTHER||Difference in percentage|13.6|||||TWO_SIDED|95.0|8.6|18.6||||||A/H1N1: 2-Sided CI, difference in percents (qIRV - Licensed QIV), expressed as a percentage.||18.6|8.6|
72416028|NCT05540522|144342859|OTHER||Difference in percentage|-15.3|||||TWO_SIDED|95.0|-19.5|-11.2||||||B/Yamagata: 2-Sided CI, difference in percents (qIRV - Licensed QIV), expressed as a percentage.||-11.2|-19.5|
72416029|NCT05540522|144342859|OTHER||Difference in percentage|-40.5|||||TWO_SIDED|95.0|-44.7|-36.1||||||B/Victoria: 2-Sided CI, difference in percents (qIRV - Licensed QIV), expressed as a percentage.||-36.1|-44.7|
72416030|NCT05540522|144342860|OTHER||Difference in percentage|21.6|||||TWO_SIDED|95.0|16.7|26.5||||||A/H3N2: 2-Sided CI, difference in percents (qIRV - Licensed QIV), expressed as a percentage.||26.5|16.7|
72416031|NCT05540522|144342860|OTHER||Difference in percentage|25.7|||||TWO_SIDED|95.0|20.9|30.4||||||A/H1N1: 2-Sided CI, difference in percents (qIRV - Licensed QIV), expressed as a percentage.||30.4|20.9|
72416032|NCT05540522|144342860|OTHER||Difference in percentage|-2.1|||||TWO_SIDED|95.0|-4.8|0.6||||||B/Yamagata: 2-Sided CI, difference in percents (qIRV - Licensed QIV), expressed as a percentage.||0.6|-4.8|
72416033|NCT05540522|144342860|OTHER||Difference in percentage|-22.6|||||TWO_SIDED|95.0|-26.7|-18.5||||||B/Victoria: 2-Sided CI, difference in percents (qIRV - Licensed QIV), expressed as a percentage.||-18.5|-26.7|
72416034|NCT05540522|144342861|OTHER||GMR|1.92|||||TWO_SIDED|95.0|1.78|2.07||||||A/H3N2||2.07|1.78|
72416035|NCT05540522|144342861|OTHER||GMR|1.68|||||TWO_SIDED|95.0|1.55|1.82||||||A/H1N1||1.82|1.55|
72416036|NCT05540522|144342861|OTHER||GMR|0.88|||||TWO_SIDED|95.0|0.82|0.94||||||B/Yamagata||0.94|0.82|
72416037|NCT05540522|144342861|OTHER||GMR|0.58|||||TWO_SIDED|95.0|0.53|0.63||||||B/Victoria||0.63|0.53|
72600276|NCT03035916|144730223|OTHER|||||||0.314||||||"The plasma level of glucose (Glu) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to 24 hours after surgery row."|t-test, 2 sided|||"The plasma level of glucose (Glu) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to 24 hours after surgery row."||||0.314
72600277|NCT03035916|144730223|OTHER|||||||0.001|||||||t-test, 2 sided|||"The plasma level of glucose (Glu) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to 24 hours after surgery row."||||0.001
72600278|NCT03035916|144730223|OTHER|||||||0.001|||||||t-test, 2 sided|||"The plasma level of glucose (Glu) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to 24 hours after surgery row."||||0.001
72600279|NCT03035916|144730223|OTHER|||||||0.087|||||||t-test, 2 sided|||"The plasma level of glucose (Glu) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to 48 hours after surgery row."||||0.087
72600280|NCT03035916|144730223|OTHER|||||||0.023|||||||t-test, 2 sided|||"The plasma level of glucose (Glu) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to 48 hours after surgery row."||||0.023
72600281|NCT03035916|144730223|OTHER|||||||0.001|||||||t-test, 2 sided|||"The plasma level of glucose (Glu) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to 48 hours after surgery row."||||0.001
72600282|NCT03035916|144730224|OTHER|||||||0.384|||||||t-test, 2 sided|||"The Heart rate was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to Baseline row."||||0.384
72600283|NCT03035916|144730224|OTHER|||||||0.53|||||||t-test, 2 sided|||"The Heart rate was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to Baseline row."||||0.530
72600284|NCT03035916|144730224|OTHER|||||||0.819|||||||t-test, 2 sided|||"The Heart rate was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to Baseline row."||||0.819
72416038|NCT05540522|144342862|OTHER||GMR|2.38|||||TWO_SIDED|95.0|2.23|2.54||||||A/H3N2||2.54|2.23|
72416039|NCT05540522|144342862|OTHER||GMR|2.37|||||TWO_SIDED|95.0|2.22|2.54||||||A/H1N1||2.54|2.22|
72600285|NCT03035916|144730224|OTHER|||||||0.108|||||||t-test, 2 sided|||"The Heart rate was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to Before induction row."||||0.108
72600286|NCT03035916|144730224|OTHER|||||||0.667|||||||t-test, 2 sided|||"The Heart rate was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to Before induction row."||||0.667
72600287|NCT03035916|144730224|OTHER|||||||0.046|||||||t-test, 2 sided|||"The Heart rate was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to Before induction row."||||0.046
72600288|NCT03035916|144730224|OTHER|||||||0.006|||||||t-test, 2 sided|||"The Heart rate was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to Induction row."||||0.006
72600289|NCT03035916|144730224|OTHER|||||||0.406|||||||t-test, 2 sided|||"The Heart rate was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to Induction row."||||0.406
72600290|NCT03035916|144730224|OTHER|||||||0.042|||||||t-test, 2 sided|||"The Heart rate was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to Induction row."||||0.042
72600291|NCT03035916|144730224|OTHER|||||||0.655|||||||t-test, 2 sided|||"The Heart rate was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to Intubation row."||||0.655
72600292|NCT03035916|144730224|OTHER|||||||0.262|||||||t-test, 2 sided|||"The Heart rate was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to Intubation row."||||0.262
72600293|NCT03035916|144730224|OTHER|||||||0.143|||||||t-test, 2 sided|||"The Heart rate was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to Intubation row."||||0.143
72600294|NCT03035916|144730224|OTHER|||||||0.494|||||||t-test, 2 sided|||"The Heart rate was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to Incision row."||||0.494
72600295|NCT03035916|144730224|OTHER|||||||0.001|||||||t-test, 2 sided|||"The Heart rate was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to Incision row."||||0.001
72600296|NCT03035916|144730224|OTHER|||||||0.001|||||||t-test, 2 sided|||"The Heart rate was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to Incision row."||||0.001
72600297|NCT03035916|144730224|OTHER|||||||0.555|||||||t-test, 2 sided|||"The Heart rate was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to Extubation row."||||0.555
72600298|NCT03035916|144730224|OTHER|||||||0.411|||||||t-test, 2 sided|||"The Heart rate was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to Extubation row."||||0.411
72600299|NCT03035916|144730224|OTHER|||||||0.167|||||||t-test, 2 sided|||"The Heart rate was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to Extubation row."||||0.167
72416040|NCT05540522|144342862|OTHER||GMR|1.36|||||TWO_SIDED|95.0|1.29|1.43||||||B/Yamagata||1.43|1.29|
72416041|NCT05540522|144342862|OTHER||GMR|0.76|||||TWO_SIDED|95.0|0.71|0.81||||||B/Victoria||0.81|0.71|
72416042|NCT05540522|144342863|OTHER||Difference in Percentage|26.8|||||TWO_SIDED|95.0|23.7|29.9||||||A/H3N2: 2-Sided CI, difference in percents (qIRV - Licensed QIV), expressed as a percentage.||29.9|23.7|
72416043|NCT05540522|144342863|OTHER||Difference in Percentage|26.9|||||TWO_SIDED|95.0|23.9|29.8||||||A/H1N1: 2-Sided CI, difference in percents (qIRV - Licensed QIV), expressed as a percentage.||29.8|23.9|
72416044|NCT05540522|144342863|OTHER||Difference in Percentage|-3.6|||||TWO_SIDED|95.0|-6.6|-0.6||||||B/Yamagata: 2-Sided CI, difference in percents (qIRV - Licensed QIV), expressed as a percentage.||-0.6|-6.6|
72600300|NCT03035916|144730224|OTHER|||||||0.445|||||||t-test, 2 sided|||"The Heart rate was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to 6 hours after surgery row."||||0.445
72600301|NCT03035916|144730224|OTHER|||||||0.489|||||||t-test, 2 sided|||"The Heart rate was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to 6 hours after surgery row."||||0.489
72600302|NCT03035916|144730224|OTHER|||||||0.159|||||||t-test, 2 sided|||"The Heart rate was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to 6 hours after surgery row."||||0.159
72600303|NCT03035916|144730224|OTHER|||||||0.72|||||||t-test, 2 sided|||"The Heart rate was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to 24 hours after surgery row."||||0.720
72600304|NCT03035916|144730224|OTHER|||||||0.026|||||||t-test, 2 sided|||"The Heart rate was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to 24 hours after surgery row."||||0.026
72600305|NCT03035916|144730224|OTHER|||||||0.011|||||||t-test, 2 sided|||"The Heart rate was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to 24 hours after surgery row."||||0.011
72416045|NCT05540522|144342863|OTHER||Difference in Percentage|-19.2|||||TWO_SIDED|95.0|-21.9|-16.6||||||B/Victoria: 2-Sided CI, difference in percents (qIRV - Licensed QIV), expressed as a percentage.||-16.6|-21.9|
72416046|NCT05540522|144342864|OTHER||Difference in Percentage|37.9|||||TWO_SIDED|95.0|35.2|40.5||||||A/H3N2: 2-Sided CI, difference in percents (qIRV - Licensed QIV), expressed as a percentage.||40.5|35.2|
72416047|NCT05540522|144342864|OTHER||Difference in Percentage|44.9|||||TWO_SIDED|95.0|42.4|47.4||||||A/H1N1: 2-Sided CI, difference in percents (qIRV - Licensed QIV), expressed as a percentage.||47.4|42.4|
72600306|NCT03035916|144730224|OTHER|||||||0.763|||||||t-test, 2 sided|||"The Heart rate was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to 48 hours after surgery row."||||0.763
72600307|NCT03035916|144730224|OTHER|||||||0.187|||||||t-test, 2 sided|||"The Heart rate was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to 48 hours after surgery row."||||0.187
72600308|NCT03035916|144730224|OTHER|||||||0.112|||||||t-test, 2 sided|||"The Heart rate was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to 48 hours after surgery row."||||0.112
72600309|NCT03035916|144730225|OTHER|||||||0.645|||||||t-test, 2 sided|||"The mean arterial pressure(MAP) was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to Baseline row."||||0.645
72600310|NCT03035916|144730225|OTHER|||||||0.645|||||||t-test, 2 sided|||"The mean arterial pressure(MAP) was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to Baseline row."||||0.645
72600311|NCT03035916|144730225|OTHER|||||||0.314|||||||t-test, 2 sided|||"The mean arterial pressure(MAP) was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to Baseline row."||||0.314
72600312|NCT03035916|144730225|OTHER|||||||0.003|||||||t-test, 2 sided|||"The mean arterial pressure(MAP) was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to Before induction row."||||0.003
72600313|NCT03035916|144730225|OTHER|||||||0.367|||||||t-test, 2 sided|||"The mean arterial pressure(MAP) was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to Before induction row."||||0.367
72600314|NCT03035916|144730225|OTHER|||||||0.031|||||||t-test, 2 sided|||"The mean arterial pressure(MAP) was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to Before induction row."||||0.031
72600315|NCT03035916|144730225|OTHER|||||||0.009|||||||t-test, 2 sided|||"The mean arterial pressure(MAP) was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to Induction row."||||0.009
72416048|NCT05540522|144342864|OTHER||Difference in Percentage|10.6|||||TWO_SIDED|95.0|8.5|12.8||||||B/Yamagata: 2-Sided CI, difference in percents (qIRV - Licensed QIV), expressed as a percentage.||12.8|8.5|
72416049|NCT05540522|144342864|OTHER||Difference in Percentage|-13.8|||||TWO_SIDED|95.0|-16.3|-11.3||||||B/Victoria: 2-Sided CI, difference in percents (qIRV - Licensed QIV), expressed as a percentage.||-11.3|-16.3|
72416050|NCT04951336|144342914|SUPERIORITY||ratio of frequencies|0.04||||1|TWO_SIDED||||||Chi-squared, Corrected|||||||1.000
72600316|NCT03035916|144730225|OTHER|||||||0.873|||||||t-test, 2 sided|||"The mean arterial pressure(MAP) was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to Induction row."||||0.873
72600317|NCT03035916|144730225|OTHER|||||||0.026|||||||t-test, 2 sided|||"The mean arterial pressure(MAP) was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to Induction row."||||0.026
72600318|NCT03035916|144730225|OTHER|||||||0.411|||||||t-test, 2 sided|||"The mean arterial pressure(MAP) was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to Intubation row."||||0.411
72600319|NCT03035916|144730225|OTHER|||||||0.787|||||||t-test, 2 sided|||"The mean arterial pressure(MAP) was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to Intubation row."||||0.787
72600320|NCT03035916|144730225|OTHER|||||||0.306|||||||t-test, 2 sided|||"The mean arterial pressure(MAP) was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to Intubation row."||||0.306
72416051|NCT04951336|144342915|SUPERIORITY||ratio of frequencies|0.06||||1|TWO_SIDED||||||Chi-squared, Corrected|||||||1.000
72416052|NCT04951336|144342916|SUPERIORITY||ratio of frequencies|0.7||||1|TWO_SIDED||||||Chi-squared, Corrected|||||||1.000
72416053|NCT04951336|144342917|SUPERIORITY||ratio of frequencies|1.68||||0.359|TWO_SIDED||||||Chi-squared, Corrected|||||||0.359
72416054|NCT04951336|144342918|SUPERIORITY|age was included as a covariate||||||0.002||||||Differences were considered statistically significant for p-values \<0.05.|Mixed Models Analysis|F(2,150)=6.374. The analysis was repeated using log-transformed values and the resultant p value was also \< 0.05||"The LME analysis compared antibodies between two grouping factors, (1) Treatment Group (FoTv vs. Placebo) and (2) Exposure Stratum (previously exposed vs. unexposed), across four time points (days 3, 14, 28, and 6 months). At baseline, participants with detectable anti-CoV-2 antibodies were deemed previously exposed and those with no or very low anti-CoV-2 Abs previously unexposed. Accordingly, all longitudinal analyses excluded baseline antibody data."||||0.002
72600321|NCT03035916|144730225|OTHER|||||||0.921|||||||t-test, 2 sided|||"The mean arterial pressure(MAP) was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to Incision row."||||0.921
72600322|NCT03035916|144730225|OTHER|||||||0.001|||||||t-test, 2 sided|||"The mean arterial pressure(MAP) was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to Incision row."||||0.001
72600323|NCT03035916|144730225|OTHER|||||||0.001|||||||t-test, 2 sided|||"The mean arterial pressure(MAP) was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to Incision row."||||0.001
72600324|NCT03035916|144730225|OTHER|||||||0.555|||||||t-test, 2 sided|||"The mean arterial pressure(MAP) was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to Extubation row."||||0.555
72600325|NCT03035916|144730225|OTHER|||||||0.058|||||||t-test, 2 sided|||"The mean arterial pressure(MAP) was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to Extubation row."||||0.058
72600326|NCT03035916|144730225|OTHER|||||||0.166|||||||t-test, 2 sided|||"The mean arterial pressure(MAP) was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to Extubation row."||||0.166
72600327|NCT03035916|144730225|OTHER|||||||0.288|||||||t-test, 2 sided|||"The mean arterial pressure(MAP) was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to 6 hours after surgery row."||||0.288
72600328|NCT03035916|144730225|OTHER|||||||0.299|||||||t-test, 2 sided|||"The mean arterial pressure(MAP) was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to 6 hours after surgery row."||||0.299
72600329|NCT03035916|144730225|OTHER|||||||0.051|||||||t-test, 2 sided|||"The mean arterial pressure(MAP) was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to 6 hours after surgery row."||||0.051
72600330|NCT03035916|144730225|OTHER|||||||0.186|||||||t-test, 2 sided|||"The mean arterial pressure(MAP) was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to 24 hours after surgery row."||||0.186
72600331|NCT03035916|144730225|OTHER|||||||0.555|||||||t-test, 2 sided|||"The mean arterial pressure(MAP) was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to 24 hours after surgery row."||||0.555
72600332|NCT03035916|144730225|OTHER|||||||0.065|||||||t-test, 2 sided|||"The mean arterial pressure(MAP) was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to 24 hours after surgery row."||||0.065
72600333|NCT03035916|144730225|OTHER|||||||0.168|||||||t-test, 2 sided|||"The mean arterial pressure(MAP) was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to 48 hours after surgery row."||||0.168
72600334|NCT03035916|144730225|OTHER|||||||0.739|||||||t-test, 2 sided|||"The mean arterial pressure(MAP) was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to 48 hours after surgery row."||||0.739
72600335|NCT03035916|144730225|OTHER|||||||0.079|||||||t-test, 2 sided|||"The mean arterial pressure(MAP) was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to 48 hours after surgery row."||||0.079
72600336|NCT03035916|144730226|OTHER|||||||0.056|||||||t-test, 2 sided|||||||0.056
72600337|NCT03035916|144730226|OTHER|||||||0.001|||||||t-test, 2 sided|||||||0.001
72600338|NCT03035916|144730226|OTHER|||||||0.001|||||||t-test, 2 sided|||||||0.001
72600339|NCT03035916|144730227|OTHER|||||||0.056||||||p\<0.05 indicates that the data difference is statistically significant.|t-test, 2 sided|||"The pain score were measured from 1 hour to 48hours after surgery. This Statistical Analysis applied to 1 hour after surgery row."||||0.056
72600340|NCT03035916|144730227|OTHER|||||||0.009||||||p\<0.05 indicates that the data difference is statistically significant.|t-test, 2 sided|||"The pain score were measured from 1 hour to 48hours after surgery. This Statistical Analysis applied to 1 hour after surgery row."||||0.009
72600341|NCT03035916|144730227|OTHER|||||||0.001||||||p\<0.05 indicates that the data difference is statistically significant.|t-test, 2 sided|||"The pain score were measured from 1 hour to 48hours after surgery. This Statistical Analysis applied to 1 hour after surgery row."||||0.001
72600342|NCT03035916|144730227|OTHER|||||||0.198|||||||t-test, 2 sided|||"The pain score were measured from 1 hour to 48hours after surgery. This Statistical Analysis applied to 6 hours after surgery row."||||0.198
72600343|NCT03035916|144730227|OTHER|||||||0.047|||||||t-test, 2 sided|||"The pain score were measured from 1 hour to 48hours after surgery. This Statistical Analysis applied to 6 hours after surgery row."||||0.047
72600344|NCT03035916|144730227|OTHER|||||||0.002|||||||t-test, 2 sided|||"The pain score were measured from 1 hour to 48hours after surgery. This Statistical Analysis applied to 6 hours after surgery row."||||0.002
72600345|NCT03035916|144730227|OTHER|||||||0.102|||||||t-test, 2 sided|||"The pain score were measured from 1 hour to 48hours after surgery. This Statistical Analysis applied to 12 hours after surgery row."||||0.102
72600346|NCT03035916|144730227|OTHER|||||||0.005|||||||t-test, 2 sided|||"The pain score were measured from 1 hour to 48hours after surgery. This Statistical Analysis applied to 12 hours after surgery row."||||0.005
72600347|NCT03035916|144730227|OTHER|||||||0.001|||||||t-test, 2 sided|||"The pain score were measured from 1 hour to 48hours after surgery. This Statistical Analysis applied to 12 hours after surgery row."||||0.001
72600348|NCT03035916|144730227|OTHER|||||||0.001|||||||t-test, 2 sided|||"The pain score were measured from 1 hour to 48hours after surgery. This Statistical Analysis applied to 24 hours after surgery row."||||0.001
72600349|NCT03035916|144730227|OTHER|||||||0.023|||||||t-test, 2 sided|||"The pain score were measured from 1 hour to 48hours after surgery. This Statistical Analysis applied to 24 hours after surgery row."||||0.023
72600350|NCT03035916|144730227|OTHER|||||||0.001|||||||t-test, 2 sided|||"The pain score were measured from 1 hour to 48hours after surgery. This Statistical Analysis applied to 24 hours after surgery row."||||0.001
72600351|NCT03035916|144730227|OTHER|||||||0.425|||||||t-test, 2 sided|||"The pain score were measured from 1 hour to 48hours after surgery. This Statistical Analysis applied to 48 hours after surgery row."||||0.425
72600352|NCT03035916|144730227|OTHER|||||||0.124|||||||t-test, 2 sided|||"The pain score were measured from 1 hour to 48hours after surgery. This Statistical Analysis applied to 48 hours after surgery row."||||0.124
72600353|NCT03035916|144730227|OTHER|||||||0.052|||||||t-test, 2 sided|||"The pain score were measured from 1 hour to 48hours after surgery. This Statistical Analysis applied to 48 hours after surgery row."||||0.052
72600354|NCT03035916|144730228|OTHER|||||||0.176||||||p\<0.05 indicates that the data difference is statistically significant.|t-test, 2 sided|||"The pain score were measured from 1 hour to 48hours after surgery. This Statistical Analysis applied to 1 hour after surgery row."||||0.176
72600355|NCT03035916|144730228|OTHER|||||||0.001||||||p\<0.05 indicates that the data difference is statistically significant.|t-test, 2 sided|||"The pain score were measured from 1 hour to 48hours after surgery. This Statistical Analysis applied to 1 hour after surgery row."||||0.001
72600356|NCT03035916|144730228|OTHER|||||||0.228|||||||t-test, 2 sided|||"The pain score were measured from 1 hour to 48hours after surgery. This Statistical Analysis applied to 6 hours after surgery row."||||0.228
72600357|NCT03035916|144730228|OTHER|||||||0.001|||||||t-test, 2 sided|||"The pain score were measured from 1 hour to 48hours after surgery. This Statistical Analysis applied to 6 hours after surgery row."||||0.001
72600358|NCT03035916|144730228|OTHER|||||||0.001|||||||t-test, 2 sided|||"The pain score were measured from 1 hour to 48hours after surgery. This Statistical Analysis applied to 6 hours after surgery row."||||0.001
72600359|NCT03035916|144730228|OTHER|||||||0.057|||||||t-test, 2 sided|||"The pain score were measured from 1 hour to 48hours after surgery. This Statistical Analysis applied to 12 hours after surgery row."||||0.057
72600360|NCT03035916|144730228|OTHER|||||||0.001|||||||t-test, 2 sided|||"The pain score were measured from 1 hour to 48hours after surgery. This Statistical Analysis applied to 12 hours after surgery row."||||0.001
72600361|NCT03035916|144730228|OTHER|||||||0.001|||||||t-test, 2 sided|||"The pain score were measured from 1 hour to 48hours after surgery. This Statistical Analysis applied to 12 hours after surgery row."||||0.001
72600362|NCT03035916|144730228|OTHER|||||||0.004|||||||t-test, 2 sided|||"The pain score were measured from 1 hour to 48hours after surgery. This Statistical Analysis applied to 24 hours after surgery row."||||0.004
72600363|NCT03035916|144730228|OTHER|||||||0.005|||||||t-test, 2 sided|||"The pain score were measured from 1 hour to 48hours after surgery. This Statistical Analysis applied to 24 hours after surgery row."||||0.005
72600364|NCT03035916|144730228|OTHER|||||||0.001|||||||t-test, 2 sided|||"The pain score were measured from 1 hour to 48hours after surgery. This Statistical Analysis applied to 24 hours after surgery row."||||0.001
72600365|NCT03035916|144730228|OTHER|||||||0.002|||||||t-test, 2 sided|||"The pain score were measured from 1 hour to 48hours after surgery. This Statistical Analysis applied to 48 hours after surgery row."||||0.002
72600366|NCT03035916|144730228|OTHER|||||||0.002|||||||t-test, 2 sided|||"The pain score were measured from 1 hour to 48hours after surgery. This Statistical Analysis applied to 48 hours after surgery row."||||0.002
72600367|NCT03035916|144730228|OTHER|||||||0.001|||||||t-test, 2 sided|||"The pain score were measured from 1 hour to 48hours after surgery. This Statistical Analysis applied to 48 hours after surgery row."||||0.001
72600368|NCT03035916|144730229|OTHER|||||||0.585|||||||t-test, 2 sided|||||||0.585
72600369|NCT03035916|144730229|OTHER|||||||0.071|||||||t-test, 2 sided|||||||0.071
72600370|NCT03035916|144730229|OTHER|||||||0.13|||||||t-test, 2 sided|||||||0.13
72600371|NCT03035916|144730230|OTHER|||||||0.644|||||||t-test, 2 sided|||||||0.644
72600372|NCT03035916|144730230|OTHER|||||||0.045|||||||t-test, 2 sided|||||||0.045
72600373|NCT03035916|144730230|OTHER|||||||0.031|||||||t-test, 2 sided|||||||0.031
72600374|NCT03035916|144730231|OTHER|||||||0.421|||||||t-test, 2 sided|||||||0.421
72600375|NCT03035916|144730231|OTHER|||||||0.046|||||||t-test, 2 sided|||||||0.046
72600376|NCT03035916|144730231|OTHER|||||||0.007|||||||t-test, 2 sided|||||||0.007
72600377|NCT03035916|144730232|OTHER|||||||0.91|||||||t-test, 2 sided|||||||0.910
72600378|NCT03035916|144730232|OTHER|||||||0.864|||||||t-test, 2 sided|||||||0.864
72600379|NCT03035916|144730232|OTHER|||||||0.785|||||||t-test, 2 sided|||||||0.785
72600380|NCT03035916|144730233|OTHER|||||||0.972|||||||t-test, 2 sided|||||||0.972
72600381|NCT03035916|144730233|OTHER|||||||0.987|||||||t-test, 2 sided|||||||0.987
72600382|NCT03035916|144730233|OTHER|||||||0.518|||||||t-test, 2 sided|||||||0.518
72600383|NCT02636439|144730249|SUPERIORITY||Mean Difference (Final Values)|44.0||||0.21|TWO_SIDED|95.0|-25.0|112.0|||ANCOVA|adjusted for baseline value, age, and sex.||||112|-25|0.21
72600384|NCT02636439|144730250|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.86|TWO_SIDED|95.0|-1.0|0.8|||ANCOVA|Adjusted for baseline value, age, and sex.||||0.8|-1.0|0.86
72600385|NCT02636439|144730251|SUPERIORITY||Mean Difference (Final Values)|0.5||||0.77|TWO_SIDED|95.0|-2.8|3.8|||ANCOVA|Adjusted for baseline value, age, and sex.||||3.8|-2.8|0.77
72600386|NCT02636439|144730252|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.85|TWO_SIDED|95.0|-0.3|0.2|||ANCOVA|Adjusted for baseline value, age, and sex.||||0.2|-0.3|0.85
72600387|NCT02636439|144730253|SUPERIORITY||Mean Difference (Final Values)|6.4||||0.053|TWO_SIDED|95.0|-0.1|12.9|||ANCOVA|Adjusted for baseline value, age, and sex.||||12.9|-0.1|0.053
72600388|NCT02636439|144730254|SUPERIORITY||Mean Difference (Final Values)|0.07||||0.043|TWO_SIDED|95.0|0.0|0.13|||ANCOVA|Adjusted for baseline value, age, and sex.||||0.13|0.00|0.043
72600389|NCT02636439|144730255|SUPERIORITY||Mean Difference (Final Values)|-5.0||||0.07|TWO_SIDED|95.0|-10.0|0.0|||ANCOVA|Adjusted for baseline value, age, and sex.||||0|-10|0.07
72600390|NCT02636439|144730256|SUPERIORITY||Mean Difference (Final Values)|-0.5||||0.79|TWO_SIDED|95.0|-4.4|3.3|||ANCOVA|Adjusted for baseline value, age, and sex.||||3.3|-4.4|0.79
72600391|NCT04679948|144730259|OTHER||Ratio of GLSMs [%]|112.06|||||TWO_SIDED|90.0|101.02|124.3|||||"Ratio of Geometric Least Squares Means (GLSMs) was calculated as (GLSM of BI 730357 + caffeine/GLSM of caffeine). Intra-individual geometric coefficient of variation (gCV \[%\]) =16.2."|The statistical model used for the analysis of the primary endpoints was an analysis of variance (ANOVA) model on the logarithmic scale. That is, the PK endpoints were logtransformed (natural logarithm) prior to fitting the ANOVA model. These quantities were then back-transformed to the original scale to provide the point estimate and 90% CIs for each endpoint. This model included effects accounting for the following sources of variation: subjects (random effect) and treatment (fixed effect).||124.30|101.02|
72600392|NCT04679948|144730260|OTHER||Ratio of GLSMs [%]|96.74|||||TWO_SIDED|90.0|91.55|102.23|||||"Ratio of Geometric Least Squares Means (GLSMs) was calculated as (GLSM of BI 730357 + caffeine/GLSM of caffeine). Intra-individual geometric coefficient of variation (gCV \[%\]) = 8.6."|The statistical model used for the analysis of the primary endpoints was an analysis of variance (ANOVA) model on the logarithmic scale. That is, the PK endpoints were logtransformed (natural logarithm) prior to fitting the ANOVA model. These quantities were then back-transformed to the original scale to provide the point estimate and 90% CIs for each endpoint. This model included effects accounting for the following sources of variation: subjects (random effect) and treatment (fixed effect).||102.23|91.55|
72600393|NCT04679948|144730261|OTHER||Ratio of GLSMs [%]|110.38|||||TWO_SIDED|90.0|107.15|113.71|||||"Ratio of Geometric Least Squares Means (GLSMs) was calculated as (GLSM of BI 730357 + warfarin/GLSM of Warfarin). Intra-individual geometric coefficient of variation (gCV \[%\]) =4.8."|The statistical model used for the analysis of the primary endpoints was an analysis of variance (ANOVA) model on the logarithmic scale. That is, the PK endpoints were logtransformed (natural logarithm) prior to fitting the ANOVA model. These quantities were then back-transformed to the original scale to provide the point estimate and 90% CIs for each endpoint. This model included effects accounting for the following sources of variation: subjects (random effect) and treatment (fixed effect).||113.71|107.15|
72600394|NCT04679948|144730262|OTHER||Ratio of GLSMs [%]|108.47|||||TWO_SIDED|90.0|104.11|113.01|||||"Ratio of Geometric Least Squares Means (GLSMs) was calculated as (GLSM of BI 730357 + warfarin/GLSM of Warfarin). Intra-individual geometric coefficient of variation (gCV \[%\]) = 6.6."|The statistical model used for the analysis of the primary endpoints was an analysis of variance (ANOVA) model on the logarithmic scale. That is, the PK endpoints were logtransformed (natural logarithm) prior to fitting the ANOVA model. These quantities were then back-transformed to the original scale to provide the point estimate and 90% CIs for each endpoint. This model included effects accounting for the following sources of variation: subjects (random effect) and treatment (fixed effect).||113.01|104.11|
72600395|NCT04679948|144730263|OTHER||Ratio of GLSM [%]|99.74|||||TWO_SIDED|90.0|89.66|110.95|||||"Ratio of Geometric Least Squares Means (GLSM) was calculated as (GLSM of BI 730357 + omeprazole/GLSM of Omeprazole). Intra-individual geometric coefficient of variation (gCV \[%\]) =12.3."|The statistical model used for the analysis of the primary endpoints was an analysis of variance (ANOVA) model on the logarithmic scale. That is, the PK endpoints were logtransformed (natural logarithm) prior to fitting the ANOVA model. These quantities were then back-transformed to the original scale to provide the point estimate and 90% CIs for each endpoint. This model included effects accounting for the following sources of variation: subjects (random effect) and treatment (fixed effect).||110.95|89.66|
72600396|NCT04679948|144730264|OTHER||Ratio of GLSMs [%]|71.32|||||TWO_SIDED|90.0|44.64|113.96|||||"Ratio of Geometric Least Squares Means (GLSMs) was calculated as (GLSM of BI 730357 + omeprazole/GLSM of Omeprazole). Intra-individual geometric coefficient of variation (gCV \[%\]) =87.8."|The statistical model used for the analysis of the primary endpoints was an analysis of variance (ANOVA) model on the logarithmic scale. That is, the PK endpoints were logtransformed (natural logarithm) prior to fitting the ANOVA model. These quantities were then back-transformed to the original scale to provide the point estimate and 90% CIs for each endpoint. This model included effects accounting for the following sources of variation: subjects (random effect) and treatment (fixed effect).||113.96|44.64|
72600397|NCT04679948|144730265|OTHER||Ratio of GLSMs [%]|126.85|||||TWO_SIDED|90.0|119.15|135.05|||||"Ratio of Geometric Least Squares Means (GLSMs) was calculated as (GLSM of BI 730357 + midazolam/GLSM of Midazolam). Intra-individual geometric coefficient of variation (gCV \[%\]) =10.1."|The statistical model used for the analysis of the primary endpoints was an analysis of variance (ANOVA) model on the logarithmic scale. That is, the PK endpoints were logtransformed (natural logarithm) prior to fitting the ANOVA model. These quantities were then back-transformed to the original scale to provide the point estimate and 90% CIs for each endpoint. This model included effects accounting for the following sources of variation: subjects (random effect) and treatment (fixed effect).||135.05|119.15|
72600398|NCT04679948|144730266|OTHER||Ratio of GLSMs [%]|130.25|||||TWO_SIDED|90.0|121.25|139.92|||||"Ratio of Geometric Least Squares Means (GLSMs) was calculated as (GLSM of BI 730357 + midazolam/GLSM of Midazolam). Intra-individual geometric coefficient of variation (gCV \[%\]) =11.6."|The statistical model used for the analysis of the primary endpoints was an analysis of variance (ANOVA) model on the logarithmic scale. That is, the PK endpoints were logtransformed (natural logarithm) prior to fitting the ANOVA model. These quantities were then back-transformed to the original scale to provide the point estimate and 90% CIs for each endpoint. This model included effects accounting for the following sources of variation: subjects (random effect) and treatment (fixed effect).||139.92|121.25|
72600399|NCT04227405|144730281|SUPERIORITY||Slope|0.24|STANDARD_ERROR_OF_MEAN|0.23|>|0.05|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change between pre-test and post-test for the Positive Conflict Management subscale using multilevel modeling||||>.05
72600400|NCT04227405|144730281|SUPERIORITY||Slope|1.59|STANDARD_ERROR_OF_MEAN|0.29|<|0.001|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change between pre-test and post-test for the Positive Conflict Management subscale using multilevel modeling||||<.001
72600401|NCT04227405|144730281|SUPERIORITY||Slope|1.35|STANDARD_ERROR_OF_MEAN|0.36|<|0.001|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||The increase from pre-test to post-test in the intervention group is significantly different from the change from pre-test to post-test in the control group|Difference between the control and the intervention group in the change from Pre-test to Post-test in the Positive Conflict Management subscale||||<.001
72600402|NCT04227405|144730281|SUPERIORITY||Slope|0.47|STANDARD_ERROR_OF_MEAN|0.23|>|0.05|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from pre-test to post-test in Negative Conflict Management for the Control Group||||>.05
72600403|NCT04227405|144730281|SUPERIORITY||Slope|-1.48|STANDARD_ERROR_OF_MEAN|0.29|<|0.01|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from pre-test to post-test in the Negative Conflict Management subscale||||<.01
72600404|NCT04227405|144730281|SUPERIORITY||Slope|-1.0|STANDARD_ERROR_OF_MEAN|0.36|<|0.01|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||The expected decrease from pre-test to post-test in the intervention group is significantly different from the change from pre-test to post-test in the control group|Difference between the control and the intervention group in the change from Pre-test to Post-test in the Negative Conflict Management subscale||||<.01
72600405|NCT04227405|144730281|SUPERIORITY||Slope|0.33|STANDARD_ERROR_OF_MEAN|0.14|<|0.05|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes in the Relationship Quality subscale from Pre-test to post-test in the control group||||<.05
72600406|NCT04227405|144730281|SUPERIORITY||Slope|0.86|STANDARD_ERROR_OF_MEAN|0.17|<|0.001|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling|||Changes in the Relationship Quality Subscale from pretest to posttest in the intervention group|A positive value indicates an increase while a negative value indicates a decrease|||<.001
72600407|NCT04227405|144730281|SUPERIORITY||Slope|0.53|STANDARD_ERROR_OF_MEAN|0.22|<|0.05|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling|||Difference between the control and the intervention group in the change from Pre-test to Post-test in the Relationship Qualitty subscale|The expected increase from pre-test to post-test in the intervention group is significantly different from the change from pre-test to post-test in the control group|||<.05
72600408|NCT04227405|144730281|SUPERIORITY||Slope|-0.32|STANDARD_ERROR_OF_MEAN|0.11|<|0.05|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to posttest in the Emotional Abuse subscale for the control group||||<.05
72600409|NCT04227405|144730281|SUPERIORITY||Slope|-0.71|STANDARD_ERROR_OF_MEAN|0.13|<|0.001|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling|||Changes from pre-test to posttest in the Emotional Abuse subscale for the intervention group|A positive value indicates an increase while a negative value indicates a decrease|||<.001
72600410|NCT04227405|144730281|SUPERIORITY||Slope|-0.39|STANDARD_ERROR_OF_MEAN|0.16|<|0.05|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling|||Difference between the control and the intervention group in the change from Pre-test to Post-test in the Emotional Abuse subscale|The expected decrease from pre-test to post-test in the intervention group is significantly different from the change from pre-test to post-test in the control group|||<.05
72416055|NCT04951336|144342919|SUPERIORITY|age was included as a covariate||||||0.002||||||p \< 0.05.|Mixed Models Analysis|F(2,157)=4.286. The analysis was repeated using log-transformed values and the resultant p value was also \< 0.05||"LME analysis compared antibodies between two grouping factors, (1) Treatment Group (FoTv vs. Placebo) and (2) Exposure Stratum (previously exposed vs. unexposed), across four time points (days 3, 14, 28, and 6 months). At baseline, participants with detectable anti-CoV-2 antibodies were deemed previously exposed and those with no or very low anti-CoV-2 Abs previously unexposed. Accordingly, all longitudinal analyses excluded baseline antibody data."||||0.002
72416056|NCT04951336|144342920|SUPERIORITY|||||||0.06|||||||Mixed Models Analysis|F(8,325)=1.898. Age was included as a covariate in this analysis.||LME analysis compared symptoms between two grouping factors, (1) Treatment Group (FoTv vs. Placebo) and (2) Exposure Stratum (previously exposed vs. unexposed), across 5 time points (days 1-5)||||0.060
72416057|NCT04951336|144342921|SUPERIORITY|LME analysis compared symptoms between two grouping factors, (1) Treatment Group (FoTv vs. Placebo) and (2) Exposure Stratum (previously exposed vs. unexposed), across 5 time points (days 1-5)||||||0.326|||||||Mixed Models Analysis|F(8,309)=1.156. Age was included as a covariate in this analysis.||||||0.326
72416058|NCT00936390|144342922|SUPERIORITY||Hazard Ratio (HR)|0.85||||0.22|TWO_SIDED|95.0|0.65|1.11||One-sided significance level 0.025 (reported p-value is two-sided)|Log Rank||Reference level = radiation therapy alone arm|This study was designed to detect an improvement in the 5-year overall survival rate from 90% (radiation alone arm) to 93.3% (radiation and androgen deprivation arm). Assuming an exponential survival distribution for each arm, this translates to a 34% relative reduction (hazard ratio 0.66) in the yearly death rate. At least 218 deaths provide 85% power with a 1-sided significance level of 0.025 and 85% power.||1.11|0.65|0.22
72600411|NCT04227405|144730281|SUPERIORITY||Slope|0.02|STANDARD_ERROR_OF_MEAN|0.04|>|0.05|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling|||Changes from pre-test to posttest in the Relationship Satisfaction subscale for the control group|A positive value indicates an increase while a negative value indicates a decrease|||>.05
72600412|NCT04227405|144730281|SUPERIORITY||Slope|0.28|STANDARD_ERROR_OF_MEAN|0.05|<|0.001|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||The expected increase from pre-test to post-test in the intervention group is significantly different from the change from pre-test to post-test in the control group|Changes from pre-test to posttest in the Relationship satisfaction subscale for the intervention group||||<.001
72600413|NCT04227405|144730281|SUPERIORITY||Slope|0.26|STANDARD_ERROR_OF_MEAN|0.06|<|0.001|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||The expected increase from pre-test to post-test in the intervention group is significantly different from the change from pre-test to post-test in the control group|Difference between the control and the intervention group in the change from Pre-test to Post-test in the Relationship Satisfactionn subscale||||<.001
72600414|NCT04227405|144730281|SUPERIORITY||Slope|-0.05|STANDARD_ERROR_OF_MEAN|0.04|>|0.05|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to posttest in the Relationship Commitment subscale for the control group||||>.05
72416059|NCT00936390|144342923|SUPERIORITY||Hazard Ratio (HR)|0.52|||<|0.001|TWO_SIDED|95.0|0.39|0.7||One-sided significance level 0.025 (reported p-value is two-sided)|Log Rank||Reference level = radiation therapy alone arm|Cause-specific hazard model||0.70|0.39|<0.001
72416060|NCT00936390|144342923|SUPERIORITY||||||<|0.001||||||One-sided significance level 0.025 (reported p-value is two-sided)|Gray's test|||Cumulative incidence model||||<0.001
72416061|NCT00936390|144342924|SUPERIORITY||Hazard Ratio (HR)|0.44||||0.02|TWO_SIDED|95.0|0.22|0.9||One-sided significance level 0.025 (reported p-value is two-sided)|Log Rank||Reference level = radiation therapy alone arm|Cause-specific hazard model||0.90|0.22|0.020
72416062|NCT00936390|144342924|SUPERIORITY|Cumulative incidence model||||||0.021||||||One-sided significance level 0.025 (reported p-value is two-sided)|Gray's test|||||||0.021
72416063|NCT00936390|144342926|SUPERIORITY||Hazard Ratio (HR)|0.25|||<|0.001|TWO_SIDED|95.0|0.11|0.57||One-sided significance level 0.025 (reported p-value is two-sided)|Log Rank||Reference level = radiation therapy alone arm|Cause-specific hazard model||0.57|0.11|<0.001
72416064|NCT00936390|144342926|SUPERIORITY||||||<|0.001||||||One-sided significance level 0.025 (reported p-value is two-sided)|Gray's test|||Cumulative incidence model||||<0.001
72416065|NCT00936390|144342927|SUPERIORITY||Hazard Ratio (HR)|0.1||||0.0073|TWO_SIDED|95.0|0.01|0.8||One-sided significance level 0.025 (reported p-value is two-sided)|Log Rank||Reference level = radiation therapy alone arm|Cause-specific hazard model||0.80|0.01|0.0073
72416066|NCT00936390|144342927|SUPERIORITY|||||||0.007||||||One-sided significance level 0.025 (reported p-value is two-sided)|Gray's test|||Cumulative incidence model||||0.007
72600415|NCT04227405|144730281|SUPERIORITY||Slope|0.22|STANDARD_ERROR_OF_MEAN|0.06|<|0.001|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to posttest in the Relationship Commitment subscale for the intervention group||||<.001
72600416|NCT04227405|144730281|SUPERIORITY||Slope|0.27|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||The expected increase from pre-test to post-test in the intervention group is significantly different from the change from pre-test to post-test in the control group|Difference between the control and the intervention group in the change from Pre-test to Post-test in the Relationship Commitment subscale||||<.001
72600417|NCT04227405|144730281|SUPERIORITY||Slope|-0.7|STANDARD_ERROR_OF_MEAN|0.17|<|0.001|TWO_SIDED|||||No adjustment in p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to posttest in the Depression subscale for the control group||||<.001
72600418|NCT04227405|144730281|SUPERIORITY||Slope|-0.81|STANDARD_ERROR_OF_MEAN|0.21|<|0.001|TWO_SIDED|||||No adjustment in p value|Multilevel modeling|||Changes from pre-test to posttest in the Depression subscale for the control group|A positive value indicates an increase while a negative value indicates a decrease|||<.001
72600419|NCT04227405|144730281|SUPERIORITY||Slope|-0.11|STANDARD_ERROR_OF_MEAN|0.26|>|0.05|TWO_SIDED|||||No adjustment in p value|Multilevel modeling||Changes from pre-test to post-test in the intervention group were not significantly different from the change from pre-test to post-test in the control group|Difference between the control and the intervention group in the change from Pre-test to Post-test in the Depression subscale||||>.05
72600420|NCT04227405|144730281|SUPERIORITY||Slope|-0.26|STANDARD_ERROR_OF_MEAN|0.1|>|0.05|TWO_SIDED|||||No adjustment in p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to posttest in the Anxiety subscale for the control group||||>.05
72600421|NCT04227405|144730281|SUPERIORITY||Slope|-0.41|STANDARD_ERROR_OF_MEAN|0.12|<|0.001|TWO_SIDED|||||No adjustment in p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to posttest in the Anxiety subscale for the intervention group||||<.001
72600422|NCT04227405|144730281|SUPERIORITY||Slope|-0.15|STANDARD_ERROR_OF_MEAN|0.16|>|0.05|TWO_SIDED|||||No adjustment in p value|Multilevel modeling||Changes from pre-test and post-test in the intervention group were not significantly different from the change from pre-test and post-test in the control group|Difference between the control and the intervention group in the change from Pre-test to Post-test in the Anxiety subscale||||>.05
72600423|NCT04227405|144730281|SUPERIORITY||Slope|0.11|STANDARD_ERROR_OF_MEAN|0.04|<|0.05|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to posttest in Budgeting subscale for the control group||||<.05
72600424|NCT04227405|144730281|SUPERIORITY||Slope|0.23|STANDARD_ERROR_OF_MEAN|0.05|<|0.001|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to posttest in the Budgeting subscale for the intervention group||||<.001
72600425|NCT04227405|144730281|SUPERIORITY||Slope|0.12|STANDARD_ERROR_OF_MEAN|0.05|<|0.1|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||Changes from pre-test to follow-up in the intervention group were not significantly different from the change from pre-test to follow-up in the control group|Difference between the control and the intervention group in the change from Pre-test to Post-test in the Budgeting subscale||||<.10
72600426|NCT04227405|144730281|SUPERIORITY||Slope|-0.1|STANDARD_ERROR_OF_MEAN|0.05|<|0.1|TWO_SIDED|||||No adjustment in p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to posttest in the Difficulties to Pay Bills subscale for the control group||||<.10
72600427|NCT04227405|144730281|SUPERIORITY||Slope|-0.21|STANDARD_ERROR_OF_MEAN|0.06|<|0.001|TWO_SIDED|||||No adjustment in p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to posttest in the Difficulties to Pay Bills subscale for the intervention group||||<.001
72600428|NCT04227405|144730281|SUPERIORITY||Slope|-0.12|STANDARD_ERROR_OF_MEAN|0.08|>|0.05|TWO_SIDED|||||No adjustment in p value|Multilevel modeling|||Difference between the control and the intervention group in the change from Pre-test to Post-test in the Difficulties to Pay Bills subscale|Changes from pre-test to post-test in the intervention group were not significantly different from the change from pre-test to post-test in the control group|||>.05
72600429|NCT04227405|144730281|SUPERIORITY||Slope|0.11|STANDARD_ERROR_OF_MEAN|0.11|>|0.05|TWO_SIDED|||||No adjustment in p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to posttest in Time with Partner subscale for the control group||||>.05
72600430|NCT04227405|144730281|SUPERIORITY||Slope|0.28|STANDARD_ERROR_OF_MEAN|0.13|<|0.05|TWO_SIDED|||||No adjustment in p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to posttest in Time with Partner subscale for the intervention group||||<.05
72600431|NCT04227405|144730281|SUPERIORITY||Slope|0.16|STANDARD_ERROR_OF_MEAN|0.17|>|0.05|TWO_SIDED|||||No adjustment in p value|Multilevel modeling||Changes from pre-test to pos-test in the intervention group were not significantly different from the change from pre-test to pos-test in the control group|Difference between the control and the intervention group in the change from Pre-test to Post-test in Time with Partner subscale||||>.05
72600432|NCT04227405|144730281|SUPERIORITY||Slope|0.03|STANDARD_ERROR_OF_MEAN|0.04|>|0.05|TWO_SIDED|||||No adjustment in p value|Multilevel modeling||Positive values indicate an increase whereas a negative value indicates a decrease|Change from pre-test to post-test in banking subscale for control group||||>.05
72416067|NCT00936390|144342928|SUPERIORITY||Hazard Ratio (HR)|0.92||||0.52|TWO_SIDED|95.0|0.7|1.2||One-sided significance level 0.025 (reported p-value is two-sided)|Log Rank||Reference level = radiation therapy alone arm|Cause-specific hazard model||1.20|0.70|0.52
72600433|NCT04227405|144730281|SUPERIORITY||Slope|0.04|STANDARD_ERROR_OF_MEAN|0.05|>|0.05|TWO_SIDED|||||No adjustment in p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from pre-test to post-test in banking subscale for the intervention group||||>.05
72416068|NCT00936390|144342928|SUPERIORITY|||||||0.56||||||One-sided significance level 0.025 (reported p-value is two-sided)|Gray's test|||Cumulative incidence model||||0.56
72416069|NCT00936390|144342929|SUPERIORITY||Hazard Ratio (HR)|0.62||||0.025|TWO_SIDED|95.0|0.41|0.95||One-sided significance level 0.025 (reported p-value is two-sided)|Log Rank||Reference level = radiation therapy alone arm|Cause-specific hazard model||0.95|0.41|0.025
72416070|NCT00936390|144342929|SUPERIORITY|||||||0.025||||||One-sided significance level 0.025 (reported p-value is two-sided)|Gray's test|||Cumulative incidence model||||0.025
72416071|NCT00936390|144342931|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
72600434|NCT04227405|144730281|SUPERIORITY||Slope|0.02|STANDARD_ERROR_OF_MEAN|0.06|>|0.05|TWO_SIDED|||||No adjustment in p value|Multilevel modeling|||Difference between the control and the intervention group in the change from Pre-test to Post-test in Banking subscale|Changes from pre-test to post-test in the intervention group were not significantly different from the change from pre-test to pos-test in the control group|||>.05
72600435|NCT04227405|144730281|SUPERIORITY||Slope|-0.05|STANDARD_ERROR_OF_MEAN|0.07|>|0.05|TWO_SIDED|||||No adjustment in p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from pre-test to post-test in parenting stress subscale for the control group||||>.05
72600436|NCT04227405|144730281|SUPERIORITY||Slope|-0.09|STANDARD_ERROR_OF_MEAN|0.08|>|0.05|TWO_SIDED|||||No adjustment in p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from pre-test to post-test in parenting stress subscale for the intervention group||||>.05
72600437|NCT04227405|144730281|SUPERIORITY||Slope|-0.05|STANDARD_ERROR_OF_MEAN|0.11|>|0.05|TWO_SIDED|||||No adjustment in p value|Multilevel modeling||Changes from pre-test to post-test in the intervention group were not significantly different from the change from pre-test to pos-test in the control group|Difference between the control and the intervention group in the change from Pre-test to Post-test in Parenting stresss subscale||||>.05
72600438|NCT04227405|144730281|SUPERIORITY||Slope|0.14|STANDARD_ERROR_OF_MEAN|0.04|<|0.001|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from pre-test to post-test in conflict management satisfaction subscale for the control group||||<.001
72600439|NCT04227405|144730281|SUPERIORITY||Slope|0.32|STANDARD_ERROR_OF_MEAN|0.05|<|0.001|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from pre-test to post-test in conflict management satisfaction subscale for the intervention group||||<.001
72600440|NCT04227405|144730281|SUPERIORITY||Slope|0.19|STANDARD_ERROR_OF_MEAN|0.06|<|0.001|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||The increase from pre-test to post-test in the intervention group is significantly different from the change from pre-test to post-test in the control group|Difference between the control and the intervention group in the change from Pre-test to Post-test in Conflict Management Satisfaction subscale||||<.001
72600441|NCT04227405|144730282|SUPERIORITY||Slope|0.18|STANDARD_ERROR_OF_MEAN|0.28|>|0.05|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to Follow-up in the Positive Conflict Management subscale for the control group||||>.05
72600442|NCT04227405|144730282|SUPERIORITY||Slope|1.53|STANDARD_ERROR_OF_MEAN|0.35|<|0.001|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to Follow-up in the Positive Conflict Management subscale for the intervention group||||<.001
72600443|NCT04227405|144730282|SUPERIORITY||Slope|1.35|STANDARD_ERROR_OF_MEAN|0.44|<|0.01|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||Difference between the control and the intervention group in the change from Pre-test to Follow-up in the Positive Conflict Management subscale|Difference between the control and the intervention group in the change from Pre-test to Follow-up n the Positive Conflict Management subscale||||<.01
72600444|NCT04227405|144730282|SUPERIORITY||Slope|-0.41|STANDARD_ERROR_OF_MEAN|0.28|>|0.05|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to Follow-up in the Negative Conflict subscale for the control group||||>.05
72600445|NCT04227405|144730282|SUPERIORITY||Slope|-1.4|STANDARD_ERROR_OF_MEAN|0.34|<|0.001|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling|||Changes from pre-test to Follow-up in the Negative Conflict Manageement subscale for the intervention group|A positive value indicates an increase while a negative value indicates a decrease|||<.001
72600446|NCT04227405|144730282|SUPERIORITY||Slope|-0.99|STANDARD_ERROR_OF_MEAN|0.44|<|0.01|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||The expected decrease from pre-test to follow-i\[in the intervention group is significantly different from the change from pre-test to follow-up in the control group|Difference between the control and the intervention group in the change from Pre-test to Follow-up n the Negative Conflict Management subscale||||<.01
72600447|NCT04227405|144730282|SUPERIORITY||Slope|0.41|STANDARD_ERROR_OF_MEAN|0.17|>|0.05|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to Follow-up in the Relationship Quality subscale for the control group||||>.05
72600448|NCT04227405|144730282|SUPERIORITY||Slope|0.91|STANDARD_ERROR_OF_MEAN|0.21|<|0.001|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to Follow-up in the Relationship Quality subscale for the intervention group||||<.001
72600449|NCT04227405|144730282|SUPERIORITY||Slope|0.5|STANDARD_ERROR_OF_MEAN|0.26|<|0.1|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables. Pvalue set at \<.05|Multilevel modeling||The expected increase from pre-test to follow-up in the intervention group is not significantly (p \> .05) different from the change from pre-test to follow-up in the control group|Difference between the control and the intervention group in the change from Pre-test to Follow-up n the Relationship Quality subscale||||<.10
72600450|NCT04227405|144730282|SUPERIORITY||Slope|-0.31|STANDARD_ERROR_OF_MEAN|0.13|<|0.1|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to Follow-up in the Emotional Abuse subscale for the control group||||<.10
72600451|NCT04227405|144730282|SUPERIORITY||Slope|-0.71|STANDARD_ERROR_OF_MEAN|0.16|<|0.001|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to Follow-up in the Emotional Abuse subscale for the intervention group||||<.001
72600452|NCT04227405|144730282|SUPERIORITY||Slope|-0.41|STANDARD_ERROR_OF_MEAN|0.2|<|0.1|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||The expected decrease from pre-test to follow-up in the intervention group is not significantly (p \> .05) different from the change from pre-test to follow-up in the control group|Difference between the control and the intervention group in the change from Pre-test to Follow-up in the Emotional Abuse subscale||||<.10
72600453|NCT04227405|144730282|SUPERIORITY||Slope|0.03|STANDARD_ERROR_OF_MEAN|0.05|>|0.05|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to Follow-up in the Relationship subscale for the control group||||>.05
72600454|NCT04227405|144730282|SUPERIORITY||Slope|0.29|STANDARD_ERROR_OF_MEAN|0.06|<|0.001|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to Follow-up in the Relationship Satisfaction subscale for the intervention group||||<.001
72416072|NCT00936390|144342932|SUPERIORITY||Hazard Ratio (HR)|1.17||||0.13|TWO_SIDED|95.0|0.89|1.53||One-sided significance level 0.025 (reported p-value is one-sided)|Gray's test||Reference level = radiation therapy alone arm|||1.53|0.89|0.13
72600455|NCT04227405|144730282|SUPERIORITY||Slope|0.26|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||The expected increase from pre-test to follow-up in the intervention group is significantly different from the change from pre-test to follow-up in the control group|Difference between the control and the intervention group in the change from Pre-test to Follow-up in the Relationship Satisfaction subscale||||<.001
72600456|NCT04227405|144730282|SUPERIORITY||Slope|-0.08|STANDARD_ERROR_OF_MEAN|0.06|>|0.05|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to Follow-up in the Relationship Commitment subscale for the control group||||>.05
72600457|NCT04227405|144730282|SUPERIORITY||Slope|0.24|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to Follow-up in the Relationship Commitment subscale for the intervention group||||<.001
72600458|NCT04227405|144730282|SUPERIORITY||Slope|0.32|STANDARD_ERROR_OF_MEAN|0.09|<|0.001|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||The expected increase from pre-test to follow-up in the intervention group is significantly different from the change from pre-test to follow-up in the control group|Difference between the control and the intervention group in the change from Pre-test to Follow-up in the Relationship Commitment subscale||||<.001
72600459|NCT04227405|144730282|SUPERIORITY||Slope|0.06|STANDARD_ERROR_OF_MEAN|0.1|>|0.05|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from post-test to Follow-up in the Positive Conflict Management subscale for the control group||||>.05
72600460|NCT04227405|144730282|SUPERIORITY||Slope|0.06|STANDARD_ERROR_OF_MEAN|0.1|>|0.05|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from post-test to Follow-up in the Positive Conflict Management subscale for th eintervention group||||>.05
72600461|NCT04227405|144730282|SUPERIORITY||Slope|0.0|STANDARD_ERROR_OF_MEAN|0.14|>|0.05|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||Changes from post-test to follow-up in the intervention group were not significantly different from the change from post-test to follow-up in the control group|Difference between the control and the intervention group in the change from Post-test to Follow-up in the Positive Conflict Management subscale||||>.05
72600462|NCT04227405|144730282|SUPERIORITY||Slope|0.06|STANDARD_ERROR_OF_MEAN|0.1|>|0.05|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from post-test to Follow-up in the Negative Conflict Management subscale for the control group||||>.05
72600463|NCT04227405|144730282|SUPERIORITY||Slope|-0.08|STANDARD_ERROR_OF_MEAN|0.1|>|0.05|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from post-test to Follow-up in the Negative Conflict Management subscale for the intervention group||||>.05
72600464|NCT04227405|144730282|SUPERIORITY||Slope|-0.01|STANDARD_ERROR_OF_MEAN|0.14|>|0.05|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||Changes from post-test to follow-up in the intervention group were not significantly different from the change from post-test to follow-up in the control group|Difference between the control and the intervention group in the change from Post-test to Follow-up in the Negative Conflict Management subscale||||>.05
72600465|NCT04227405|144730282|SUPERIORITY||Slope|-0.07|STANDARD_ERROR_OF_MEAN|0.06|>|0.05|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from post-test to Follow-up in the Relationship Quality subscale for the control group||||>.05
72600466|NCT04227405|144730282|SUPERIORITY||Slope|-0.05|STANDARD_ERROR_OF_MEAN|0.06|>|0.05|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from post-test to Follow-up in the Relationship Quality subscale for the intervention group||||>.05
72600467|NCT04227405|144730282|SUPERIORITY||Slope|0.03|STANDARD_ERROR_OF_MEAN|0.08|>|0.05|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||Changes from post-test to follow-up in the intervention group were not significantly different from the change from post-test to follow-up in the control group|Difference between the control and the intervention group in the change from Post-test to Follow-up in the Relationship Quality subscale||||>.05
72600468|NCT04227405|144730282|SUPERIORITY||Slope|-0.02|STANDARD_ERROR_OF_MEAN|0.04|>|0.05|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from post-test to Follow-up in the Emotional Abuse subscale for the control group||||>.05
72600469|NCT04227405|144730282|SUPERIORITY||Slope|0.0|STANDARD_ERROR_OF_MEAN|0.04|>|0.05|TWO_SIDED|||||Changes from post-test to Follow-up in the Emotional Abuse subscale for the control group|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from post-test to Follow-up in the Emotional Abuse subscale for the intervention group||||>.05
72600470|NCT04227405|144730282|SUPERIORITY||Slope|0.02|STANDARD_ERROR_OF_MEAN|0.06|>|0.05|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||Changes from post-test to follow-up in the intervention group were not significantly different from the change from post-test to follow-up in the control group|Difference between the control and the intervention group in the change from Post-test to Follow-up in the Emotional Abuse subscale||||>.05
72600471|NCT04227405|144730282|SUPERIORITY||Slope|0.0|STANDARD_ERROR_OF_MEAN|0.01|>|0.05|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from post-test to Follow-up in the Relationship Satisfaction subscale for the control group||||>.05
72600472|NCT04227405|144730282|SUPERIORITY||Slope|-0.01|STANDARD_ERROR_OF_MEAN|0.02|>|0.05|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from post-test to Follow-up in the Relationship Satisfaction subscale for the interventionn group||||>.05
72416073|NCT00936390|144342933|SUPERIORITY||Hazard Ratio (HR)|0.52|||<|0.001|TWO_SIDED|95.0|0.39|0.7||One-sided significance level 0.025 (reported p-value is two-sided)|Log Rank||Reference level = radiation therapy alone arm|Cause-specific hazard model||0.70|0.39|<0.001
72416074|NCT00936390|144342933|SUPERIORITY||||||<|0.001||||||One-sided significance level 0.025 (reported p-value is two-sided)|Gray's test|||Cumulative incidence model||||<0.001
72600473|NCT04227405|144730282|SUPERIORITY||Slope|-0.01|STANDARD_ERROR_OF_MEAN|0.02|>|0.05|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||Changes from post-test to follow-up in the intervention group were not significantly different from the change from post-test to follow-up in the control group|Difference between the control and the intervention group in the change from Post-test to Follow-up in the Relationship satisfaction subscale||||>.05
72600474|NCT04227405|144730282|SUPERIORITY||Slope|0.03|STANDARD_ERROR_OF_MEAN|0.02|>|0.05|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||Changes from post-test to Follow-up in the Emotional Abuse subscale for the control group|Changes from post-test to Follow-up in the Relationship Commitment subscale for the control group||||>.05
72600475|NCT04227405|144730282|SUPERIORITY||Slope|-0.03|STANDARD_ERROR_OF_MEAN|0.02|>|0.05|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from post-test to Follow-up in the Relationship Commitment subscale for the intervention group||||>.05
72600476|NCT04227405|144730282|SUPERIORITY||Slope|0.05|STANDARD_ERROR_OF_MEAN|0.18|>|0.05|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||Changes from post-test to follow-up in the intervention group were not significantly different from the change from post-test to follow-up in the control group|Difference between the control and the intervention group in the change from Post-test to Follow-up in the Relationship Commitment subscale||||>.05
72600477|NCT04227405|144730282|SUPERIORITY||Slope|-0.08|STANDARD_ERROR_OF_MEAN|0.05|>|0.05|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from pre-test to follow-up in banking subscale for the control group||||>.05
72600478|NCT04227405|144730282|SUPERIORITY||Slope|-0.02|STANDARD_ERROR_OF_MEAN|0.06|>|0.05|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from pre-test to follow-up in banking subscale for the intervention group||||>.05
72600479|NCT04227405|144730282|SUPERIORITY||Slope|0.07|STANDARD_ERROR_OF_MEAN|0.08|>|0.05|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||Changes from pre-test to follow-up in the intervention group were not significantly different from the change from pre-test to follow-up in the control group|Difference between the control and the intervention group in the change from pre-test to follow-up in Banking subscale||||>.05
72600480|NCT04227405|144730282|SUPERIORITY||Slope|0.11|STANDARD_ERROR_OF_MEAN|0.02|<|0.001|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from post-test to follow-up in banking subscale for the control group||||<.001
72600481|NCT04227405|144730282|SUPERIORITY||Slope|0.06|STANDARD_ERROR_OF_MEAN|0.02|<|0.001|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from post-test to follow-up in banking subscale for the intervention group||||<.001
72600482|NCT04227405|144730282|SUPERIORITY||Slope|-0.05|STANDARD_ERROR_OF_MEAN|0.03|<|0.1|TWO_SIDED|||||No adjustment to p value|Multilevel modeling|||Difference between the control and the intervention group in the change from post-test to follow-up in Banking subscale|Changes from post-test to follow-up in the intervention group were not significantly different from the change from post-test to follow-up in the control group|||<.10
72416075|NCT00936390|144342934|SUPERIORITY|||||||0.38|||||||t-test, 2 sided|||End of RT||||0.38
72416076|NCT00936390|144342934|SUPERIORITY|||||||0.032|||||||t-test, 2 sided|||6 months post-RT||||0.032
72416077|NCT00936390|144342934|SUPERIORITY|||||||0.87|||||||t-test, 2 sided|||One year post-RT||||0.87
72600483|NCT04227405|144730282|SUPERIORITY||Slope|-0.09|STANDARD_ERROR_OF_MEAN|0.06|>|0.05|TWO_SIDED|||||No adjustment in p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from pre-test to follow-up in Difficulty to Pay Bills for the control group||||>.05
72600484|NCT04227405|144730282|SUPERIORITY||Slope|-0.19|STANDARD_ERROR_OF_MEAN|0.07|<|0.05|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from pre-test to follow-up in Difficulties to Pay Bills subscale for the intervention group||||<.05
72600485|NCT04227405|144730282|SUPERIORITY||Slope|-0.1|STANDARD_ERROR_OF_MEAN|0.09|>|0.05|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||Changes from pre-test to follow-up in the intervention group were not significantly different from the change from pre-test to follow-up in the control group|Difference between the control and the intervention group in the change from pre-test to follow-up in Difficulties to pay bills subscale||||>.05
72600486|NCT04227405|144730282|SUPERIORITY||Slope|0.0|STANDARD_ERROR_OF_MEAN|0.02|>|0.05|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from post-test to follow-up in Difficulty to Pay Bills subscale for the control group||||>.05
72600487|NCT04227405|144730282|SUPERIORITY||Slope|-0.02|STANDARD_ERROR_OF_MEAN|0.03|>|0.05|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from post-test to follow-up in Difficulties to Pay Bills subscale for the intervention group||||>.05
72600488|NCT04227405|144730282|SUPERIORITY||Slope|-0.02|STANDARD_ERROR_OF_MEAN|0.03|>|0.05|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||Changes from post-test to follow-up in the intervention group were not significantly different from the change from post-test to follow-up in the control group|Difference between the control and the intervention group in the change from post-test to follow-up in Difficulty to Pay Bills subscale||||>.05
72600489|NCT04227405|144730282|SUPERIORITY||Slope|-0.69|STANDARD_ERROR_OF_MEAN|0.21|<|0.001|TWO_SIDED|||||No adjustment to p vallue|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from pre-test to follow-up in depression subscale for the control group||||<.001
72600490|NCT04227405|144730282|SUPERIORITY||Slope|-0.72|STANDARD_ERROR_OF_MEAN|0.25|<|0.001|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from pre-test to follow-up in depression subscale for the intervention group||||<.001
72600491|NCT04227405|144730282|SUPERIORITY||Slope|-0.03|STANDARD_ERROR_OF_MEAN|0.32|>|0.05|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||Changes from pre-test to follow-up in the intervention group were not significantly different from the change from pre-test to follow-up in the control group|Difference between the control and the intervention group in the change from pre-test to follow-up in Depression subscale||||>.05
72600492|NCT04227405|144730282|SUPERIORITY||Slope|-0.01|STANDARD_ERROR_OF_MEAN|0.07|>|0.05|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from post-test to follow-up in depression subscale for the control group||||>.05
72600493|NCT04227405|144730282|SUPERIORITY||Slope|-0.09|STANDARD_ERROR_OF_MEAN|0.07|>|0.05|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from post-test to follow-up in depression subscale for the intervention group||||>.05
72600494|NCT04227405|144730282|SUPERIORITY||Slope|-0.07|STANDARD_ERROR_OF_MEAN|0.1|>|0.05|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||Changes from post-test to follow-up in the intervention group were not significantly different from the change from post-test to follow-up in the control group|Difference between the control and the intervention group in the change from post-test to follow-up in depression subscale||||>.05
72600495|NCT04227405|144730282|SUPERIORITY||Slope|-0.29|STANDARD_ERROR_OF_MEAN|0.12|<|0.05|TWO_SIDED|||||No adjustment to p value|Multilevel modeling|||Change from pre-test to follow-up in the Anxiety subscale for the control group|A positive value indicates an increase while a negative value indicates a decrease|||<.05
72416078|NCT00936390|144342934|SUPERIORITY|||||||0.67|||||||t-test, 2 sided|||Five years post-RT||||0.67
72600496|NCT04227405|144730282|SUPERIORITY||Slope|-0.34|STANDARD_ERROR_OF_MEAN|0.15|<|0.05|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from pre-test to follow-up in the Anxiety subscale for the intervention group||||<.05
72600497|NCT04227405|144730282|SUPERIORITY||Slope|-0.03|STANDARD_ERROR_OF_MEAN|0.32|>|0.05|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||Changes from pre-test to follow-up in the intervention group were not significantly different from the change from pre-test to follow-up in the control group|Difference between the control and the intervention group in the change from pre-test to follow-up in Anxiety subscale||||>.05
72416079|NCT00936390|144342935|SUPERIORITY|||||||0.58|||||||t-test, 2 sided|||End of RT||||0.58
72416080|NCT00936390|144342935|SUPERIORITY|||||||0.31|||||||t-test, 2 sided|||Six months post-RT||||0.31
72416081|NCT00936390|144342935|SUPERIORITY|||||||0.36|||||||t-test, 2 sided|||One year post-RT||||0.36
72416082|NCT00936390|144342935|SUPERIORITY|||||||0.88|||||||t-test, 2 sided|||Five years post-RT||||0.88
72416083|NCT00936390|144342936|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||End of RT||||<0.001
72416084|NCT00936390|144342936|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||Six months post-RT||||<0.001
72600498|NCT04227405|144730282|SUPERIORITY||Slope|0.03|STANDARD_ERROR_OF_MEAN|0.04|>|0.05|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from post-test to follow-up in anxiety subscale for the control group||||>.05
72600499|NCT04227405|144730282|SUPERIORITY||Slope|-0.07|STANDARD_ERROR_OF_MEAN|0.04|>|0.05|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from post-test to follow-up in anxiety subscale for the control group||||>.05
72600500|NCT04227405|144730282|SUPERIORITY||Slope|-0.1|STANDARD_ERROR_OF_MEAN|0.06|>|0.05|TWO_SIDED||||||Multilevel modeling||Changes from post-test to follow-up in the intervention group were not significantly different from the change from post-test to follow-up in the control group|Difference between the control and the intervention group in the change from post-test to follow-up in the Anxiety subscale||||>.05
72600501|NCT04227405|144730282|SUPERIORITY||Slope|0.01|STANDARD_ERROR_OF_MEAN|0.09|>|0.05|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from pre-test to follow-up in parenting stress subscale for the control group||||>.05
72600502|NCT04227405|144730282|SUPERIORITY||Slope|-0.09|STANDARD_ERROR_OF_MEAN|0.1|>|0.05|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from pre-test to follow-up in parenting stress subscale for the intervention group||||>.05
72600503|NCT04227405|144730282|SUPERIORITY||Slope|-0.1|STANDARD_ERROR_OF_MEAN|0.13|>|0.05|TWO_SIDED|||||No adjustment to p value|Multilevel modeling|||Difference between the control and the intervention group in the change from pre-test to follow-up in parenting stress subscale|Changes from pre-test to follow-up in the intervention group were not significantly different from the change from pre-test to follow-up in the control group|||>.05
72600504|NCT04227405|144730282|SUPERIORITY||Slope|-0.06|STANDARD_ERROR_OF_MEAN|0.03|<|0.05|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from post-test to follow-up in banking subscale for the control group||||<.05
72600505|NCT04227405|144730282|SUPERIORITY||Slope|-0.01|STANDARD_ERROR_OF_MEAN|0.04|>|0.05|TWO_SIDED||||||Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from post-test to follow-up in parenting stress subscale for the control group||||>.05
72600506|NCT04227405|144730282|SUPERIORITY||Slope|0.05|STANDARD_ERROR_OF_MEAN|0.04|>|0.05|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||Changes from post-test to follow-up in the intervention group were not significantly different from the change from post-test to follow-up in the control group|Difference between the control and the intervention group in the change from post-test to follow-up in Parenting Stress subscale||||>.05
72600507|NCT04227405|144730282|SUPERIORITY||Slope|0.26|STANDARD_ERROR_OF_MEAN|0.13|<|0.1|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from pre-test to follow-up in Time with Partner subscale for the control group||||<.10
72600508|NCT04227405|144730282|SUPERIORITY||Slope|0.22|STANDARD_ERROR_OF_MEAN|0.16|>|0.05|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from pre-test to follow-up in Time with Parter subscale for the intervention group||||>.05
72600509|NCT04227405|144730282|SUPERIORITY||Slope|-0.04|STANDARD_ERROR_OF_MEAN|0.2|>|0.05|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||Changes from pre-test to follow-up in the intervention group were not significantly different from the change from pre-test to follow-up in the control group|Difference between the control and the intervention group in the change from pre-test to follow-up inn Time with Partner subscale||||>.05
72600510|NCT04227405|144730282|SUPERIORITY||Slope|-0.14|STANDARD_ERROR_OF_MEAN|0.04|<|0.001|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from post-test to follow-up in Time with Partner subscale for the control group||||<.001
72600511|NCT04227405|144730282|SUPERIORITY||Slope|0.05|STANDARD_ERROR_OF_MEAN|0.05|>|0.05|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from post-test to follow-up in Time with Partner subscale for the intervention group||||>.05
72600512|NCT04227405|144730282|SUPERIORITY||Slope|0.2|STANDARD_ERROR_OF_MEAN|0.06|<|0.001|TWO_SIDED|||||No adjustment to p value|Multilevel modeling|||Difference between the control and the intervention group in the change from post-test to follow-up in Time with Partner subscale|Changes from post-test to follow-up in the intervention group were significantly different from the change from post-test to follow-up in the control group|||<.001
72600513|NCT04227405|144730282|SUPERIORITY||Slope|0.13|STANDARD_ERROR_OF_MEAN|0.05|<|0.05|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from pre-test to follow-up in Conflict Management Satisfaction subscale for the control group||||<.05
72600514|NCT04227405|144730282|SUPERIORITY||Slope|0.32|STANDARD_ERROR_OF_MEAN|0.06|<|0.001|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from pre-test to follow-up in Conflict Management Satisfaction subscale for the control group||||<.001
72416085|NCT00936390|144342936|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||One year post-RT||||<0.001
72416086|NCT00936390|144342936|SUPERIORITY|||||||0.18|||||||t-test, 2 sided|||Five years post-RT||||0.18
72600515|NCT04227405|144730282|SUPERIORITY||Slope|0.19|STANDARD_ERROR_OF_MEAN|0.08|<|0.05|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||Changes from pre-test to follow-up in the intervention group were significantly different from the change from pre-test to follow-up in the control group|Difference between the control and the intervention group in the change from pre-test to follow-up in Conflict Management Satisfaction subscale||||<.05
72600516|NCT04227405|144730282|SUPERIORITY||Slope|0.01|STANDARD_ERROR_OF_MEAN|0.02|>|0.05|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from post-test to follow-up in Conflict Management Satisfaction subscale for the control group||||>.05
72600517|NCT04227405|144730282|SUPERIORITY||Slope|0.0|STANDARD_ERROR_OF_MEAN|0.02|>|0.05|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from post-test to follow-up in conflict management satisfaction subscale for the intervention group||||>.05
72600518|NCT04227405|144730282|SUPERIORITY||Slope|0.0|STANDARD_ERROR_OF_MEAN|0.02|>|0.05|TWO_SIDED|||||No adjustment to p value|Multilevel modeling|||Difference between the control and the intervention group in the change from post-test to follow-up in Conflict Management Satisfaction subscale|Changes from post-test to follow-up in the intervention group were not significantly different from the change from post-test to follow-up in the control group|||>.05
72600519|NCT04227405|144730282|SUPERIORITY||Slope|-0.1|STANDARD_ERROR_OF_MEAN|0.05|<|0.1|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from pre-test to follow-up in budgeting subscale for the control group||||<.10
72600520|NCT04227405|144730282|SUPERIORITY||Slope|0.12|STANDARD_ERROR_OF_MEAN|0.06|<|0.05|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from pre-test to follow-up in Budgeting subscale for the intervention group||||<.05
72600521|NCT04227405|144730282|SUPERIORITY||Slope|0.22|STANDARD_ERROR_OF_MEAN|0.07|<|0.01|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling|||Difference between the control and the intervention group in the change from pre-test to follow-up in Budgeting subscale|Changes from pre-test to follow-up in the intervention group were significantly different from the change from pre-test to follow-up in the control group|||<.01
72600522|NCT04227405|144730282|SUPERIORITY||Slope|0.0|STANDARD_ERROR_OF_MEAN|0.02|<|0.001|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from post-test to follow-up in budgeting subscale for the control group||||<.001
72600523|NCT04227405|144730282|SUPERIORITY||Slope|0.11|STANDARD_ERROR_OF_MEAN|0.02|<|0.001|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from post-test to follow-up in budgeting subscale for the intervention group||||<.001
72600524|NCT04227405|144730282|SUPERIORITY||Slope|-0.1|STANDARD_ERROR_OF_MEAN|0.02|<|0.001|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling|||Difference between the control and the intervention group in the change from pre-test to follow-up in Budgeting subscale|Changes from pre-test to follow-up in the intervention group were significantly different from the change from pre-test to follow-up in the control group|||<.001
72600525|NCT04227405|144730284|SUPERIORITY||Slope|-0.35|STANDARD_ERROR_OF_MEAN|0.12|<|0.05|TWO_SIDED||||||Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to posttest in the Acceptance subscale for the control group||||<.05
72600526|NCT04227405|144730284|SUPERIORITY||Slope|0.33|STANDARD_ERROR_OF_MEAN|0.14|<|0.05|TWO_SIDED||||||Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to posttest in the Acceptance subscale for the intervention group||||<.05
72416087|NCT00936390|144342937|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||End of RT||||<0.001
72600527|NCT04227405|144730284|SUPERIORITY||Slope|0.68|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED||||||Multilevel modeling||The expected increase from pre-test to post-test in the intervention group is significantly different from the change from pre-test to post-test in the control group|Difference between the control and the intervention group in the change from Pre-test to Post-test in the Acceptance subscale||||<.001
72600528|NCT04227405|144730284|SUPERIORITY||Slope|-0.34|STANDARD_ERROR_OF_MEAN|0.12|<|0.05|TWO_SIDED||||||Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to posttest in the Active Coping subscale for the control group||||<.05
72600529|NCT04227405|144730284|SUPERIORITY||Slope|0.38|STANDARD_ERROR_OF_MEAN|0.15|<|0.05|TWO_SIDED||||||Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to posttest in the Active Coping subscale for the intervention group||||<.05
72416088|NCT00936390|144342937|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||Six months post-RT||||<0.001
72416089|NCT00936390|144342937|SUPERIORITY|||||||0.0014|||||||t-test, 2 sided|||One year post-RT||||0.0014
72416090|NCT00936390|144342937|SUPERIORITY|||||||0.9|||||||t-test, 2 sided|||Five years post-RT||||0.90
72416091|NCT00936390|144342938|SUPERIORITY|||||||0.046|||||||t-test, 2 sided|||End of RT||||0.046
72600530|NCT04227405|144730284|SUPERIORITY||Slope|0.72|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED||||||Multilevel modeling|||Difference between the control and the intervention group in the change from Pre-test to Post-test in the Active Coping subscale|The expected increase from pre-test to post-test in the intervention group is significantly different from the change from pre-test to post-test in the control group|||<.001
72600531|NCT04227405|144730284|SUPERIORITY||Slope|-0.32|STANDARD_ERROR_OF_MEAN|0.12|<|0.05|TWO_SIDED||||||Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to posttest in the Planning subscale for the control group||||<.05
72600532|NCT04227405|144730284|SUPERIORITY||Slope|0.44|STANDARD_ERROR_OF_MEAN|0.15|<|0.01|TWO_SIDED||||||Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to posttest in the Planning subscale for the intervention group||||<.01
72600533|NCT04227405|144730284|SUPERIORITY||Slope|0.76|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED||||||Multilevel modeling||The expected increase from pre-test to post-test in the intervention group is significantly different from the change from pre-test to post-test in the control group|Difference between the control and the intervention group in the change from Pre-test to Post-test in the Planning subscale||||<.001
72600534|NCT04227405|144730284|SUPERIORITY||Slope|-0.15|STANDARD_ERROR_OF_MEAN|0.12|>|0.05|TWO_SIDED||||||Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to posttest in the Instrumental Support subscale for the control group||||>.05
72600535|NCT04227405|144730284|SUPERIORITY||Slope|-0.03|STANDARD_ERROR_OF_MEAN|0.15|>|0.05|TWO_SIDED||||||Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to posttest in the Instrumental Support subscale for the intervention group||||>.05
72600536|NCT04227405|144730284|SUPERIORITY||Slope|0.12|STANDARD_ERROR_OF_MEAN|0.18|>|0.05|TWO_SIDED||||||Multilevel modeling||Changes from pre-test to post-test in the intervention group were not significantly different from the change from pre-test to post-test in the control group|Difference between the control and the intervention group in the change from Pre-test to Post-test in the Instrumental Support subscale||||>.05
72600537|NCT04227405|144730285|SUPERIORITY||Slope|-0.36|STANDARD_ERROR_OF_MEAN|0.14|<|0.1|TWO_SIDED||||||Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to Follow-up in the Acceptance subscale for the control group||||<.10
72600538|NCT04227405|144730285|SUPERIORITY||Slope|0.41|STANDARD_ERROR_OF_MEAN|0.18|<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to Follow-up in the Acceptance subscale for the intervention group||||<.05
72600539|NCT04227405|144730285|SUPERIORITY||Slope|0.77|STANDARD_ERROR_OF_MEAN|0.22|<|0.001|TWO_SIDED||||||Multilevel modeling||The expected increase from pre-test to follow-up in the intervention group is significantly different from the change from pre-test to follow-up in the control group|Difference between the control and the intervention group in the change from Pre-test to Follow-up in the Aceptance subscale||||<.001
72600540|NCT04227405|144730285|SUPERIORITY||Slope|-0.36|STANDARD_ERROR_OF_MEAN|0.15|<|0.1|TWO_SIDED||||||Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to Follow-up in the Active Coping subscale for the control group||||<.10
72600541|NCT04227405|144730285|SUPERIORITY||Slope|0.4|STANDARD_ERROR_OF_MEAN|0.18|<|0.05|TWO_SIDED||||||Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to Follow-up in the Active Coping subscale for the intervention group||||<.05
72600542|NCT04227405|144730285|SUPERIORITY||Slope|0.76|STANDARD_ERROR_OF_MEAN|0.22|<|0.01|TWO_SIDED||||||Multilevel modeling||The expected increase from pre-test to follow-up in the intervention group is significantly different from the change from pre-test to follow-up in the control group|Difference between the control and the intervention group in the change from Pre-test to Follow-up in the Active Coping subscale||||<.01
72600543|NCT04227405|144730285|SUPERIORITY||Slope|-0.34|STANDARD_ERROR_OF_MEAN|0.15|<|0.1|TWO_SIDED||||||Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to Follow-up in the Planning subscale for the control group||||<.10
72600544|NCT04227405|144730285|SUPERIORITY||Slope|0.59|STANDARD_ERROR_OF_MEAN|0.18|<|0.05|TWO_SIDED||||||Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to Follow-up in the Planning subscale for the intervention group||||<.05
72600545|NCT04227405|144730285|SUPERIORITY||Slope|0.94|STANDARD_ERROR_OF_MEAN|0.23|<|0.001|TWO_SIDED||||||Multilevel modeling||The expected increase from pre-test to follow-up in the intervention group is significantly different from the change from pre-test to follow-up in the control group|Difference between the control and the intervention group in the change from Pre-test to Follow-up in the Planning subscale||||<.001
72416092|NCT00936390|144342938|SUPERIORITY|||||||0.82|||||||t-test, 2 sided|||6 months post-RT||||0.82
72416093|NCT00936390|144342938|SUPERIORITY|||||||0.82|||||||t-test, 2 sided|||One year post-RT||||0.82
72416094|NCT00936390|144342938|SUPERIORITY|||||||0.79|||||||t-test, 2 sided|||Five years post-RT||||0.79
72600546|NCT04227405|144730285|SUPERIORITY||Slope|-0.11|STANDARD_ERROR_OF_MEAN|0.15|>|0.05|TWO_SIDED||||||Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to Follow-up in the Instrumental Support subscale for the control group||||>.05
72600547|NCT04227405|144730285|SUPERIORITY||Slope|0.02|STANDARD_ERROR_OF_MEAN|0.18|>|0.05|TWO_SIDED||||||Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to Follow-up in the Instrumental Support subscale for the Intervention group||||>.05
72600548|NCT04227405|144730285|SUPERIORITY||Slope|0.13|STANDARD_ERROR_OF_MEAN|0.23|>|0.05|TWO_SIDED||||||Multilevel modeling||Changes from pre-test to follow-up in the intervention group were not significantly different from the change from pre-test to follow-up in the control group|Difference between the control and the intervention group in the change from Pre-test to Follow-up in the Instrumental Support subscale||||>.05
72600549|NCT04227405|144730285|SUPERIORITY||Slope|0.02|STANDARD_ERROR_OF_MEAN|0.05|>|0.05|TWO_SIDED||||||Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from post-test to Follow-up in the Acceptance subscale for the control group||||>.05
72600550|NCT04227405|144730285|SUPERIORITY||Slope|-0.07|STANDARD_ERROR_OF_MEAN|0.05|>|0.05|TWO_SIDED||||||Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from post-test to Follow-up in the Acceptance subscale for the intervention group||||>.05
72600551|NCT04227405|144730285|SUPERIORITY||Slope|-0.09|STANDARD_ERROR_OF_MEAN|0.07|>|0.05|TWO_SIDED||||||Multilevel modeling||Changes from post-test to follow-up in the intervention group were not significantly different from the change from post-test to follow-up in the control group|Difference between the control and the intervention group in the change from Post-test to Follow-up in the Positive Conflict Management subscale||||>.05
72600552|NCT04227405|144730285|SUPERIORITY|Changes from post-test to Follow-up in the Active Coping subscale for the control group|Slope|0.02|STANDARD_ERROR_OF_MEAN|0.05|>|0.05|TWO_SIDED||||||Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|||||>.05
72600553|NCT04227405|144730285|SUPERIORITY||Slope|-0.03|STANDARD_ERROR_OF_MEAN|0.05|>|0.05|TWO_SIDED||||||Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from post-test to Follow-up in the Active Coping subscale for the intervention group||||>.05
72600554|NCT04227405|144730285|SUPERIORITY||Slope|-0.04|STANDARD_ERROR_OF_MEAN|0.07|>|0.05|TWO_SIDED||||||Multilevel modeling||Changes from post-test to follow-up in the intervention group were not significantly different from the change from post-test to follow-up in the control group|Difference between the control and the intervention group in the change from Post-test to Follow-up in the Active Copinng subscale||||>.05
72600555|NCT04227405|144730285|SUPERIORITY||Slope|0.02|STANDARD_ERROR_OF_MEAN|0.05|>|0.05|TWO_SIDED||||||Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from post-test to Follow-up in the Plannning subscale for the control group||||>.05
72600556|NCT04227405|144730285|SUPERIORITY||Slope|-0.15|STANDARD_ERROR_OF_MEAN|0.06|<|0.1|TWO_SIDED||||||Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from post-test to Follow-up in the Planning subscale for the intervention group||||<.10
72600557|NCT04227405|144730285|SUPERIORITY||Slope|-0.17|STANDARD_ERROR_OF_MEAN|0.07|>|0.05|TWO_SIDED||||||Multilevel modeling||Changes from post-test to follow-up in the intervention group were not significantly different from the change from post-test to follow-up in the control group|Difference between the control and the intervention group in the change from Post-test to Follow-up in the Planning subscale||||>.05
72600558|NCT04227405|144730285|SUPERIORITY||Slope|0.04|STANDARD_ERROR_OF_MEAN|0.05|>|0.05|TWO_SIDED||||||Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from post-test to Follow-up in the Instrumental Support subscale for the control group||||>.05
72600559|NCT04227405|144730285|SUPERIORITY||Slope|-0.05|STANDARD_ERROR_OF_MEAN|0.05|>|0.05|TWO_SIDED||||||Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from post-test to Follow-up in the Instrumental Support subscale for the intervention group||||>.05
72600560|NCT04227405|144730285|SUPERIORITY||Slope|-0.01|STANDARD_ERROR_OF_MEAN|0.07|>|0.05|TWO_SIDED||||||Multilevel modeling||Changes from post-test to follow-up in the intervention group were not significantly different from the change from post-test to follow-up in the control group|Difference between the control and the intervention group in the change from Post-test to Follow-up in the Instrumental Support subscale||||>.05
72600561|NCT04227405|144730287|SUPERIORITY||Slope|-0.3|STANDARD_ERROR_OF_MEAN|0.12|<|0.05|TWO_SIDED||||||Multilevel modeling||Changes from pre-test to Follow-up in the Emotional Abuse subscale for the control group|Changes from pre-test to posttest in the Acceptance subscale for the control group||||<.05
72600562|NCT04227405|144730287|SUPERIORITY||Slope|0.47|STANDARD_ERROR_OF_MEAN|0.16|<|0.01|TWO_SIDED||||||Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to posttest in the Emotional Abuse subscale for the control group||||<.01
72600563|NCT04227405|144730287|SUPERIORITY||Slope|0.77|STANDARD_ERROR_OF_MEAN|0.19|<|0.001|TWO_SIDED||||||Multilevel modeling||The expected increase from pre-test to post-test in the intervention group is significantly different from the change from pre-test to post-test in the control group|Difference between the control and the intervention group in the change from Pre-test to Post-test in the Acceptance subscale||||<.001
72600564|NCT04227405|144730287|SUPERIORITY||Slope|-0.17|STANDARD_ERROR_OF_MEAN|0.13|>|0.05|TWO_SIDED||||||Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to posttest in the Active Coping subscale for the control group||||>.05
72416095|NCT01258608|144342951|OTHER||Hazard Ratio (HR)|1.192||||0.7382|ONE_SIDED|90.0||1.737||P-value for comparison of treatment groups obtained from stratified log-rank test-stratified by Barcelona Clinic Liver Cancer and Eastern Cooperative Oncology Group (ECOG) performance status.|Stratified log-rank test||Hazard ratio comparing mapatumumab to placebo obtained from Cox proportional hazards model with covariate adjustment for Barcelona Clinic Liver Cancer and ECOG performance status.|||1.737||0.7382
72600565|NCT04227405|144730287|SUPERIORITY||Slope|0.3|STANDARD_ERROR_OF_MEAN|0.17|<|0.1|TWO_SIDED||||||Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to posttest in the Active Coping subscale for the intervention group||||<.10
72600566|NCT04227405|144730287|SUPERIORITY||Slope|0.47|STANDARD_ERROR_OF_MEAN|0.2|<|0.05|TWO_SIDED||||||Multilevel modeling||The expected increase from pre-test to post-test in the intervention group is significantly different from the change from pre-test to post-test in the control group|Difference between the control and the intervention group in the change from Pre-test to Post-test in the Active Coping subscale||||<.05
72600567|NCT04227405|144730287|SUPERIORITY||Slope|-0.38|STANDARD_ERROR_OF_MEAN|0.12|<|0.05|TWO_SIDED||||||Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to posttest in the Planning subscale for the control group||||<.05
72600568|NCT04227405|144730287|SUPERIORITY||Slope|0.37|STANDARD_ERROR_OF_MEAN|0.15|<|0.05|TWO_SIDED||||||Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to posttest in the Planning subscale for the Intervention group||||<.05
72600569|NCT04227405|144730287|SUPERIORITY||Slope|0.74|STANDARD_ERROR_OF_MEAN|0.19|<|0.001|TWO_SIDED||||||Multilevel modeling||The expected increase from pre-test to post-test in the intervention group is significantly different from the change from pre-test to post-test in the control group|Difference between the control and the intervention group in the change from Pre-test to Post-test in the Planning subscale||||<.001
72600570|NCT04227405|144730287|SUPERIORITY||Slope|-0.11|STANDARD_ERROR_OF_MEAN|0.12|>|0.05|TWO_SIDED||||||Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to posttest in the Instrumental Support subscale for the control group||||>.05
72600571|NCT04227405|144730287|SUPERIORITY||Slope|0.49|STANDARD_ERROR_OF_MEAN|0.16|<|0.01|TWO_SIDED||||||Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to posttest in the Instrumental Support subscale for the intervention group||||<.01
72600572|NCT04227405|144730287|SUPERIORITY||Slope|0.6|STANDARD_ERROR_OF_MEAN|0.19|<|0.01|TWO_SIDED||||||Multilevel modeling||The expected increase from pre-test to post-test in the intervention group is significantly different from the change from pre-test to post-test in the control group|Difference between the control and the intervention group in the change from Pre-test to Post-test in the Instrumental Support subscale||||<.01
72600573|NCT04227405|144730288|SUPERIORITY||Slope|-0.25|STANDARD_ERROR_OF_MEAN|0.15|>|0.05|TWO_SIDED||||||Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to Follow-up in the Acceptance subscale for the control group||||>.05
72600574|NCT04227405|144730288|SUPERIORITY||Slope|0.52|STANDARD_ERROR_OF_MEAN|0.19|<|0.01|TWO_SIDED||||||Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to Follow-up in the Acceptance subscale for the intervention group||||<.01
72600575|NCT04227405|144730288|SUPERIORITY||Slope|0.78|STANDARD_ERROR_OF_MEAN|0.24|<|0.01|TWO_SIDED||||||Multilevel modeling|||Difference between the control and the intervention group in the change from Pre-test to Follow-up in the Acceptance subscale|The expected increase from pre-test to follow-up in the intervention group is significantly different from the change from pre-test to follow-up in the control group|||<.01
72600576|NCT04227405|144730288|SUPERIORITY||Slope|0.09|STANDARD_ERROR_OF_MEAN|0.16|>|0.05|TWO_SIDED||||||Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to Follow-up in the Active Coping subscale for the control group||||>.05
72600577|NCT04227405|144730288|SUPERIORITY||Slope|0.36|STANDARD_ERROR_OF_MEAN|0.2|<|0.1|TWO_SIDED||||||Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to Follow-up in the Active Coping subscale for the intervention group||||<.10
72600578|NCT04227405|144730288|SUPERIORITY||Slope|0.4|STANDARD_ERROR_OF_MEAN|0.25|<|0.1|TWO_SIDED||||||Multilevel modeling||Changes from pre-test to follow-up in the intervention group were not significantly different from the change from pre-test to follow-up in the control group|Difference between the control and the intervention group in the change from Pre-test to Follow-up in the Active Coping subscale||||<.10
72600579|NCT04227405|144730288|SUPERIORITY||Slope|-0.31|STANDARD_ERROR_OF_MEAN|0.15|<|0.1|TWO_SIDED||||||Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to Follow-up in the Planning subscale for the control group||||<.10
72600580|NCT04227405|144730288|SUPERIORITY||Slope|0.4|STANDARD_ERROR_OF_MEAN|0.18|<|0.05|TWO_SIDED||||||Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to Follow-up in the Planning subscale for the intervention group||||<.05
72600581|NCT04227405|144730288|SUPERIORITY||Slope|0.71|STANDARD_ERROR_OF_MEAN|0.23|<|0.01|TWO_SIDED||||||Multilevel modeling||The expected increase from pre-test to follow-up in the intervention group is significantly different from the change from pre-test to follow-up in the control group|Difference between the control and the intervention group in the change from Pre-test to Follow-up in the Planning subscale||||<.01
72416096|NCT01258608|144342952|OTHER||Hazard Ratio (HR)|0.922||||0.3156|ONE_SIDED|90.0||1.288||P-value for comparison of treatment groups obtained from stratified log-rank test-stratified by Barcelona Clinic Liver Cancer and Eastern Cooperative Oncology Group (ECOG) performance status.|Stratified log-rank test||Hazard ratio comparing mapatumumab to placebo obtained from Cox proportional hazards model with covariate adjustment for Barcelona Clinic Liver Cancer and ECOG performance status.|||1.288||0.3156
72600582|NCT04227405|144730288|SUPERIORITY||Slope|-0.02|STANDARD_ERROR_OF_MEAN|0.16|>|0.05|TWO_SIDED||||||Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to Follow-up in the Instrumental Support subscale for the control group||||>.05
72600583|NCT04227405|144730288|SUPERIORITY||Slope|0.64|STANDARD_ERROR_OF_MEAN|0.19|<|0.01|TWO_SIDED||||||Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to Follow-up in the Instrumental Support subscale for the intervention group||||<.01
72600584|NCT04227405|144730288|SUPERIORITY||Slope|0.66|STANDARD_ERROR_OF_MEAN|0.24|<|0.01|TWO_SIDED||||||Multilevel modeling||The expected increase from pre-test to follow-up in the intervention group is significantly different from the change from pre-test to follow-up in the control group|Difference between the control and the intervention group in the change from Pre-test to Follow-up in the Instrumental Support subscale||||<.01
72600585|NCT04227405|144730288|SUPERIORITY||Slope|-0.05|STANDARD_ERROR_OF_MEAN|0.05|>|0.05|TWO_SIDED||||||Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from post-test to Follow-up in the Acceptance subscale for the control group||||>.05
72600586|NCT04227405|144730288|SUPERIORITY||Slope|-0.06|STANDARD_ERROR_OF_MEAN|0.06|>|0.05|TWO_SIDED||||||Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from post-test to Follow-up in the Acceptance subscale for the interventionn group||||>.05
72600587|NCT04227405|144730288|SUPERIORITY||Slope|-0.01|STANDARD_ERROR_OF_MEAN|0.08|>|0.05|TWO_SIDED||||||Multilevel modeling||Changes from post-test to follow-up in the intervention group were not significantly different from the change from post-test to follow-up in the control group|Difference between the control and the intervention group in the change from Post-test to Follow-up in the Acceptance subscale||||>.05
72600588|NCT04227405|144730288|SUPERIORITY||Slope|-0.08|STANDARD_ERROR_OF_MEAN|0.06|>|0.05|TWO_SIDED||||||Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from post-test to Follow-up in the Active Coping subscale for the control group||||>.05
72600589|NCT04227405|144730288|SUPERIORITY||Slope|-0.07|STANDARD_ERROR_OF_MEAN|0.06|>|0.05|TWO_SIDED||||||Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from post-test to Follow-up in the Active Coping in the intervention group||||>.05
72600590|NCT04227405|144730288|SUPERIORITY||Slope|0.01|STANDARD_ERROR_OF_MEAN|0.08|>|0.05|TWO_SIDED||||||Multilevel modeling||Changes from post-test to follow-up in the intervention group were not significantly different from the change from post-test to follow-up in the control group|Difference between the control and the intervention group in the change from Post-test to Follow-up in the Active Coping subscale||||>.05
72600591|NCT04227405|144730288|SUPERIORITY||Slope|-0.07|STANDARD_ERROR_OF_MEAN|0.05|>|0.05|TWO_SIDED||||||Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from post-test to Follow-up in the Planning subscale for the control group||||>.05
72600592|NCT04227405|144730288|SUPERIORITY||Slope|-0.04|STANDARD_ERROR_OF_MEAN|0.06|>|0.05|TWO_SIDED||||||Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from post-test to Follow-up in the Planning subscale for the intervention group||||>.05
72600593|NCT04227405|144730288|SUPERIORITY||Slope|0.03|STANDARD_ERROR_OF_MEAN|0.07|>|0.05|TWO_SIDED||||||Multilevel modeling||Changes from post-test to follow-up in the intervention group were not significantly different from the change from post-test to follow-up in the control group|Difference between the control and the intervention group in the change from Post-test to Follow-up in Planning subscale||||>.05
72600594|NCT04227405|144730288|SUPERIORITY||Slope|-0.09|STANDARD_ERROR_OF_MEAN|0.05|>|0.05|TWO_SIDED||||||Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from post-test to Follow-up in the Instrumental Support subscale for the control group||||>.05
72600595|NCT04227405|144730288|SUPERIORITY||Slope|-0.15|STANDARD_ERROR_OF_MEAN|0.06|<|0.1|TWO_SIDED||||||Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from post-test to Follow-up in the Instrumental Support subscale for the intervention group||||<.10
72600596|NCT04227405|144730288|SUPERIORITY||Slope|-0.06|STANDARD_ERROR_OF_MEAN|0.08|>|0.05|TWO_SIDED||||||Multilevel modeling||Changes from post-test to follow-up in the intervention group were not significantly different from the change from post-test to follow-up in the control group|Difference between the control and the intervention group in the change from Post-test to Follow-up in the Instrumental Supportt subscale||||>.05
72600597|NCT04227405|144730290|SUPERIORITY||Slope|-1.41|STANDARD_ERROR_OF_MEAN|0.49|<|0.05|TWO_SIDED||||||Multilevel modeling|||Changes from pre-test to posttest for the control group|A positive value indicates an increase while a negative value indicates a decrease|||<.05
72600598|NCT04227405|144730290|SUPERIORITY||Slope|2.02|STANDARD_ERROR_OF_MEAN|0.69|<|0.01|TWO_SIDED||||||Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to posttest for the intervention group||||<.01
72600599|NCT04227405|144730290|SUPERIORITY||Slope|-0.62|STANDARD_ERROR_OF_MEAN|0.83|>|0.05|TWO_SIDED||||||Multilevel modeling||Changes from pre-test to post-test t in the intervention group were not significantly different from the change from pre-test to post-test in the control group|Difference between the control and the intervention group in the change from Pre-test to Post-test||||>.05
72600600|NCT04227405|144730291|SUPERIORITY||Slope|-1.48|STANDARD_ERROR_OF_MEAN|0.6|>|0.05|TWO_SIDED||||||Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to Follow-up for the control group||||>.05
72600601|NCT04227405|144730291|SUPERIORITY||Slope|-1.5|STANDARD_ERROR_OF_MEAN|0.82|<|0.1|TWO_SIDED||||||Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to Follow-up for the intervention group||||<.10
72600602|NCT04227405|144730291|SUPERIORITY||Slope|-0.02|STANDARD_ERROR_OF_MEAN|1.01|>|0.05|TWO_SIDED||||||Multilevel modeling||Changes from pre-test to follow-up in the intervention group were not significantly different from the change from pre-test to follow-up in the control group|Difference between the control and the intervention group in the change from Pre-test to Follow-up||||>.05
72600603|NCT04227405|144730291|SUPERIORITY||Slope|0.08|STANDARD_ERROR_OF_MEAN|0.02|>|0.05|TWO_SIDED||||||Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from post-test to Follow-up for the control group||||>.05
72600604|NCT04227405|144730291|SUPERIORITY||Slope|-0.52|STANDARD_ERROR_OF_MEAN|0.23|>|0.05|TWO_SIDED||||||Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from post-test to Follow-up for the control group||||>.05
72600605|NCT04227405|144730291|SUPERIORITY||Slope|-0.6|STANDARD_ERROR_OF_MEAN|0.03|>|0.05|TWO_SIDED||||||Multilevel modeling||Changes from post-test to follow-up in the intervention group were not significantly different from the change from post-test to follow-up in the control group|Difference between the control and the intervention group in the change from Post-test to Follow-up||||>.05
72600606|NCT04227405|144730293|SUPERIORITY||Slope|-0.34|STANDARD_ERROR_OF_MEAN|1.16|>|0.05|TWO_SIDED|||||No adjustment for p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from pre-test to post-test in Difficulties in Emotion Regulation for the control group||||>.05
72600607|NCT04227405|144730293|SUPERIORITY||Slope|-3.07|STANDARD_ERROR_OF_MEAN|1.51|<|0.05|TWO_SIDED|||||No adjustment for p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from pre-test to post-test for the intervention group||||<.05
72600608|NCT04227405|144730293|SUPERIORITY||Slope|-2.74|STANDARD_ERROR_OF_MEAN|1.85|>|0.05|TWO_SIDED|||||No adjustment in p value|Multilevel modeling||Changes from pre-test to post-test in the intervention group were not significantly different from the change from pre-test to pos-test in the control group|Difference between the control and the intervention group in the change from Pre-test to Post-test||||>.05
72600609|NCT04227405|144730294|SUPERIORITY||Slope|-0.7|STANDARD_ERROR_OF_MEAN|1.41|>|0.05|TWO_SIDED|||||No adjustment in p value|Multilevel modeling|||Change from pre-test to follow-up for the control group|A positive value indicates an increase while a negative value indicates a decrease|||>.05
72600610|NCT04227405|144730294|SUPERIORITY||Slope|-2.74|STANDARD_ERROR_OF_MEAN|1.79|>|0.05|TWO_SIDED|||||No adjustment in p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from pre-test to follow-up for the control group||||>.05
72600611|NCT04227405|144730294|SUPERIORITY||Slope|-2.04|STANDARD_ERROR_OF_MEAN|2.24|>|0.05|TWO_SIDED|||||No adjustment in p value|Multilevel modeling||Changes from pre-test to follow-up in the intervention group were not significantly different from the change from pre-test to follow-up in the control group|Difference between the control and the intervention group in the change from pre-test to follow-up||||>.05
72600612|NCT04227405|144730294|SUPERIORITY||Slope|0.36|STANDARD_ERROR_OF_MEAN|0.46|>|0.05|TWO_SIDED|||||No adjustment in p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from post-test to follow-up for the control group||||>.05
72600613|NCT04227405|144730294|SUPERIORITY||Slope|-0.33|STANDARD_ERROR_OF_MEAN|0.5|>|0.05|TWO_SIDED|||||No adjustment in p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from post-test to follow-up for the control group||||>.05
72600614|NCT04227405|144730294|SUPERIORITY||Slope|-0.69|STANDARD_ERROR_OF_MEAN|0.68|>|0.05|TWO_SIDED|||||No adjustment in p value|Multilevel modeling||Changes from post-test to follow-up in the intervention group were not significantly different from the change from post-test to follow-up in the control group|Difference between the control and the intervention group in the change from post-test to follow-up||||>.05
72600615|NCT04227405|144730296|SUPERIORITY||Slope|-0.39|STANDARD_ERROR_OF_MEAN|0.11|<|0.001|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from pre-test to post-test in psychological agggression subscale for the control group||||<.001
72600616|NCT04227405|144730296|SUPERIORITY||Slope|-0.73|STANDARD_ERROR_OF_MEAN|0.14|<|0.001|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from pre-test to post-test in psychological aggression subscale for the intervention group||||<.001
72600617|NCT04227405|144730296|SUPERIORITY||Slope|-0.34|STANDARD_ERROR_OF_MEAN|0.17|<|0.1|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||Changes from pre-test to post-test in the intervention group were not significantly different from the change from pre-test to pos-test in the control group|Difference between the control and the intervention group in the change from Pre-test to Post-test in Psychological Aggression subscale||||<.10
72600618|NCT04227405|144730296|SUPERIORITY||Slope|0.0|STANDARD_ERROR_OF_MEAN|0.09|>|0.05|TWO_SIDED|||||No adjustment to p value|Multilevel modeling|||Change from pre-test to post-test in physical assault subscale for the control group|A positive value indicates an increase while a negative value indicates a decrease|||>.05
72600619|NCT04227405|144730296|SUPERIORITY||Slope|-0.34|STANDARD_ERROR_OF_MEAN|0.12|<|0.001|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from pre-test to post-test in the physical assault subscale for the intervention group||||<.001
72600620|NCT04227405|144730296|SUPERIORITY||Slope|-0.34|STANDARD_ERROR_OF_MEAN|0.14|<|0.05|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||Changes from pre-test to post-test in the intervention group were significantly different from the change from pre-test to pos-test in the control group|Difference between the control and the intervention group in the change from Pre-test to Post-test in Physical Assault subscale||||<.05
72600621|NCT04227405|144730297|SUPERIORITY||Slope|-0.47|STANDARD_ERROR_OF_MEAN|0.13|<|0.001|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from pre-test to follow-up in the psychological aggression subscale for the control group||||<.001
72600622|NCT04227405|144730297|SUPERIORITY||Slope|-0.77|STANDARD_ERROR_OF_MEAN|0.17|<|0.001|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from pre-test to follow-up in the Psychological Aggression subscale for the intervention group||||<.001
72416097|NCT01258608|144342953|OTHER||Hazard Ratio (HR)|1.007||||0.6121|ONE_SIDED|90.0||1.346||P-value for comparison of treatment groups obtained from stratified log-rank test-stratified by Barcelona Clinic Liver Cancer and ECOG performance status.|Stratified log-rank test||Hazard ratio comparing mapatumumab to placebo obtained from Cox proportional hazards model with covariate adjustment for Barcelona Clinic Liver Cancer and ECOG performance status.|||1.346||0.6121
72416098|NCT01258608|144342954|OTHER||Hazard Ratio (HR)|1.066||||0.6925|ONE_SIDED|90.0||1.43||P-value for comparison of treatment groups obtained from stratified log-rank test - stratified by Barcelona Clinic Liver Cancer and ECOG performance status.|Stratified log-rank test||Hazard ratio comparing Mapatumumab to placebo obtained from Cox proportional hazards model with covariate adjustment for Barcelona Clinic Liver Cancer and ECOG performance status.|||1.430||0.6925
72600623|NCT04227405|144730297|SUPERIORITY||Slope|-0.3|STANDARD_ERROR_OF_MEAN|0.21|>|0.05|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||Changes from pre-test to follow-up in the intervention group were not significantly different from the change from pre-test to follow-up in the control group|Difference between the control and the intervention group in the change from pre-test to follow-up inn the psychological aggression subscale||||>.05
72600624|NCT04227405|144730297|SUPERIORITY||Slope|0.08|STANDARD_ERROR_OF_MEAN|0.04|<|0.1|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from post-test to follow-up for the control group in the psychological aggression subscale||||<.10
72600625|NCT04227405|144730297|SUPERIORITY||Slope|0.04|STANDARD_ERROR_OF_MEAN|0.05|>|0.05|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from post-test to follow-up for the intervention group for the psychological aggresssion subscale||||>.05
72600626|NCT04227405|144730297|SUPERIORITY||Slope|-0.04|STANDARD_ERROR_OF_MEAN|0.06|>|0.05|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||Changes from post-test to follow-up in the intervention group were not significantly different from the change from post-test to follow-up in the control group|Difference between the control and the intervention group in the change from post-test to follow-up in the psychological aggression subscale||||>.05
72416099|NCT01258608|144342955|OTHER||Hazard Ratio (HR)|0.909||||0.3088|ONE_SIDED|90.0||1.191||P-value for comparison of treatment groups obtained from stratified log-rank test - stratified by Barcelona Clinic Liver Cancer and ECOG performance status.|Stratified log-rank test||Hazard ratio comparing Mapatumumab to placebo obtained from Cox proportional hazards model with covariate adjustment for Barcelona Clinic Liver Cancer and ECOG performance status.|||1.191||0.3088
72416100|NCT01258608|144342956|OTHER||Response rate difference|5.4||||0.5458|TWO_SIDED|95.0|-16.8|26.6||Nominal P-value for comparison of treatment groups obtained from Fisher's exact test.|Fisher Exact|||||26.6|-16.8|0.5458
72600627|NCT04227405|144730297|SUPERIORITY||Slope|-0.03|STANDARD_ERROR_OF_MEAN|0.12|>|0.05|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from pre-test to follow-up for the control group for the physical assault subscale||||>.05
72600628|NCT04227405|144730297|SUPERIORITY||Slope|-0.4|STANDARD_ERROR_OF_MEAN|0.15|<|0.05|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from pre-test to follow-up for the control group for the Physical Assault Subscale||||<.05
72600629|NCT04227405|144730297|SUPERIORITY||Slope|-0.37|STANDARD_ERROR_OF_MEAN|0.18|<|0.05|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||Changes from pre-test to follow-up in the intervention group were significantly different from the change from pre-test to follow-up in the control group|Difference between the control and the intervention group in the change from pre-test to follow-up for the Physical Assault subscale||||<.05
72600630|NCT04227405|144730297|SUPERIORITY||Slope|0.02|STANDARD_ERROR_OF_MEAN|0.04|>|0.05|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from post-test to follow-up for the control group for the Physical Assault subscale||||>.05
72600631|NCT04227405|144730297|SUPERIORITY||Slope|0.06|STANDARD_ERROR_OF_MEAN|0.04|>|0.05|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from post-test to follow-up for the intervention group for the Physical Assault subscale||||>.05
72600632|NCT04227405|144730297|SUPERIORITY||Slope|0.04|STANDARD_ERROR_OF_MEAN|0.06|>|0.05|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||Changes from post-test to follow-up in the intervention group were not significantly different from the change from post-test to follow-up in the control group|Difference between the control and the intervention group in the change from post-test to follow-up||||>.05
72600633|NCT04227405|144730299|SUPERIORITY||Slope|-2.12|STANDARD_ERROR_OF_MEAN|0.57|<|0.001|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from pre-test to post-test for the control group||||<.001
72600634|NCT04227405|144730299|SUPERIORITY||Slope|-4.46|STANDARD_ERROR_OF_MEAN|0.73|<|0.001|TWO_SIDED|||||No adjustment in p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from pre-test to post-test for the intervention group||||<.001
72600635|NCT04227405|144730299|SUPERIORITY||Slope|-2.34|STANDARD_ERROR_OF_MEAN|0.89|<|0.05|TWO_SIDED|||||No adjustment in p value|Multilevel modeling||Changes from pre-test to post-test in the intervention group were significantly different from the change from pre-test to pos-test in the control group|Difference between the control and the intervention group in the change from Pre-test to Post-test in Time||||<.05
72600636|NCT04227405|144730300|SUPERIORITY||Slope|-1.96|STANDARD_ERROR_OF_MEAN|0.7|<|0.05|TWO_SIDED|||||No adjustment in p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from pre-test to follow-up for the control group||||<.05
72416101|NCT01258608|144342957|OTHER||Response rate difference|6.7||||0.3479|TWO_SIDED|95.0|-13.4|26.2||Nominal P-value for comparison of treatment groups obtained from Fisher's exact test.|Fisher Exact|||||26.2|-13.4|0.3479
72416102|NCT01258608|144342958|OTHER||Disease control rate difference|-20.7||||0.0198|TWO_SIDED|95.0|-40.8|1.8||Nominal P-value for comparison of treatment groups obtained from Fisher's exact test.|Fisher Exact|||||1.8|-40.8|0.0198
72600637|NCT04227405|144730300|SUPERIORITY||Slope|-4.48|STANDARD_ERROR_OF_MEAN|0.88|<|0.001|TWO_SIDED|||||No adjustment in p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from pre-test to follow-up for the intervention group||||<.001
72416103|NCT01258608|144342959|OTHER||Disease control rate difference|-5.8||||0.6558|TWO_SIDED|95.0|-25.4|13.8||Nominal P-value for comparison of treatment groups obtained from Fisher's exact test.|Fisher Exact|||||13.8|-25.4|0.6558
72416104|NCT04098939|144342973|EQUIVALENCE|Bland-Altman plots|Bland-Altman plots|0.39|||<|0.05|TWO_SIDED|95.0|0.26|1.04||Analysis of Bland-Altman plots|Bland-Altman plots|Analysis of Bland-Altman plots|||Analysis of Bland-Altman plots|1.04|0.26|<0.05
72416105|NCT02943408|144342974|SUPERIORITY|||||||0.9|||||||Mixed Models Analysis|||||||.90
72416106|NCT02943408|144342975|SUPERIORITY|||||||0.99|||||||Mixed Models Analysis|||||||.99
72416107|NCT02943408|144342976|SUPERIORITY|||||||0.56|||||||Mixed Models Analysis|||||||.56
72416108|NCT02943408|144342977|SUPERIORITY|||||||0.85|||||||Mixed Models Analysis|||||||.85
72416109|NCT02943408|144342978|SUPERIORITY|||||||0.43|||||||Mixed Models Analysis|||||||.43
72416110|NCT02943408|144342979|SUPERIORITY|||||||0.82|||||||Mixed Models Analysis|||||||.82
72416111|NCT02943408|144342980|SUPERIORITY|||||||0.5|||||||Mixed Models Analysis|||||||.50
72416112|NCT02943408|144342981|SUPERIORITY|||||||0.56|||||||Mixed Models Analysis|||||||.56
72416113|NCT02943408|144342982|SUPERIORITY|||||||0.92|||||||Mixed Models Analysis|||||||.92
72600638|NCT04227405|144730300|SUPERIORITY||Slope|-2.52|STANDARD_ERROR_OF_MEAN|1.1|<|0.05|TWO_SIDED|||||No adjustment in p value|Multilevel modeling||Changes from pre-test to follow-up in the intervention group were significantly different from the change from pre-test to follow-up in the control group|Difference between the control and the intervention group in the change from pre-test to follow-up||||<.05
72600639|NCT04227405|144730300|SUPERIORITY||Slope|-0.16|STANDARD_ERROR_OF_MEAN|0.24|>|0.05|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from post-test to follow-up for the control group||||>.05
72600640|NCT04227405|144730300|SUPERIORITY||Slope|0.03|STANDARD_ERROR_OF_MEAN|0.26|>|0.05|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from post-test to follow-up for the control group||||>.05
72600641|NCT04227405|144730300|SUPERIORITY||Slope|0.19|STANDARD_ERROR_OF_MEAN|0.35|>|0.05|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||Changes from post-test to follow-up in the intervention group were not significantly different from the change from post-test to follow-up in the control group|Difference between the control and the intervention group in the change from post-test to follow-up||||>.05
72600642|NCT04227405|144730302|SUPERIORITY||Slope|0.37|STANDARD_ERROR_OF_MEAN|0.24|>|0.05|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from pre-test to post-test for the control group for Supportive Dyadic Coping subscale||||>.05
72600643|NCT04227405|144730302|SUPERIORITY||Slope|0.71|STANDARD_ERROR_OF_MEAN|0.31|<|0.05|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from pre-test to post-test for the intervention group||||<.05
72600644|NCT04227405|144730302|SUPERIORITY||Slope|0.33|STANDARD_ERROR_OF_MEAN|0.38|>|0.05|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling|||Difference between the control and the intervention group in the change from Pre-test to Post-test in the Supportive Dyadic Coping subscale|Changes from pre-test to post-test in the intervention group were not significantly different from the change from pre-test to post-test in the control group|||>.05
72600645|NCT04227405|144730302|SUPERIORITY||Slope|0.23|STANDARD_ERROR_OF_MEAN|0.3|>|0.05|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from pre-test to post-test for the control group for the common dyadic coping subscale||||>.05
72600646|NCT04227405|144730302|SUPERIORITY||Slope|1.21|STANDARD_ERROR_OF_MEAN|0.39|<|0.01|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from pre-test to post-test for the intervention group in the Common Dyadic Coping subscale||||<.01
72600647|NCT04227405|144730302|SUPERIORITY||Slope|0.97|STANDARD_ERROR_OF_MEAN|0.47|<|0.1|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||Changes from pre-test to post-test in the intervention group were not significantly different from the change from pre-test to post-test in the control group|Difference between the control and the intervention group in the change from Pre-test to Post-test for the Common Dyadic Coping Subscale||||<.10
72600648|NCT04227405|144730302|SUPERIORITY||Slope|-0.74|STANDARD_ERROR_OF_MEAN|0.37|<|0.1|TWO_SIDED|||||No adjustment in p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from pre-test to post-test for the control group in the Negative Dyadic Coping Subscale||||<.10
72600649|NCT04227405|144730302|SUPERIORITY||Slope|-1.14|STANDARD_ERROR_OF_MEAN|0.49|<|0.05|TWO_SIDED|||||No adjustment in p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from pre-test to post-test for the intervention group for the Negative Dyadic Coping subscale||||<.05
72416114|NCT02943408|144342983|SUPERIORITY|||||||0.65|||||||Mixed Models Analysis|||||||.65
72416115|NCT02943408|144342984|SUPERIORITY|||||||0.35|||||||Mixed Models Analysis|||||||.35
72600650|NCT04227405|144730302|SUPERIORITY||Slope|-0.39|STANDARD_ERROR_OF_MEAN|0.6|>|0.05|TWO_SIDED|||||No adjustment in p value|Multilevel modeling||Changes from pre-test to post-test in the intervention group were not significantly different from the change from pre-test to post-test in the control group|Difference between the control and the intervention group in the change from Pre-test to Post-test inn the Negative Dyadic Coping Scale||||>.05
72416116|NCT01786512|144343039|OTHER||Treatment difference|0.0112|STANDARD_ERROR_OF_MEAN|0.0033||0.0007|TWO_SIDED|95.0|0.0047|0.0176|||Repeated Measures||Repeated measures model includes treatment group, stratification factor, scheduled visit, interaction of treatment with scheduled visit and the baseline value as covariates.|||0.0176|0.0047|0.0007
72600651|NCT04227405|144730303|SUPERIORITY||Slope|0.57|STANDARD_ERROR_OF_MEAN|0.29|>|0.05|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from pre-test to follow-up for the control group for the Supportive Dyadic Coping Subscale||||>.05
72600652|NCT04227405|144730303|SUPERIORITY||Slope|0.7|STANDARD_ERROR_OF_MEAN|0.37|<|0.05|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from pre-test to follow-up for the intervention group for the Supportive Dyadic Coping Subscale||||<.05
72600653|NCT04227405|144730303|SUPERIORITY||Slope|0.19|STANDARD_ERROR_OF_MEAN|0.46|>|0.05|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||Changes from pre-test to follow-up in the intervention group were not significantly different from the change from pre-test to follow-up in the control group|Difference between the control and the intervention group in the change from pre-test to follow-up for the Supportive Dyadic Coping Subscale||||>.05
72600654|NCT04227405|144730305|SUPERIORITY||Slope|0.03|STANDARD_ERROR_OF_MEAN|0.26|>|0.05|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from pre-test to post-test for the control group in the Supportive Dyadic Coping Subcale||||>.05
72600655|NCT04227405|144730305|SUPERIORITY||Slope|1.45|STANDARD_ERROR_OF_MEAN|0.33|<|0.001|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from pre-test to post-test for the intervention group in the Supportive Dyadic Coping Scale||||<.001
72416117|NCT01786512|144343039|OTHER||Treatment difference|0.025|STANDARD_ERROR_OF_MEAN|0.0033|<|0.0001|TWO_SIDED|95.0|0.0184|0.0315|||Repeated Measures||Repeated measures model includes treatment group, stratification factor, scheduled visit, interaction of treatment with scheduled visit and the baseline value as covariates.|||0.0315|0.0184|<0.0001
72416118|NCT01786512|144343040|OTHER||Treatment difference|4.58|STANDARD_ERROR_OF_MEAN|1.56||0.0036|TWO_SIDED|95.0|1.5|7.65|||Repeated Measures||Repeated measures model includes treatment group, stratification factor, scheduled visit, interaction of treatment with scheduled visit and the baseline value as covariates.|||7.65|1.50|0.0036
72416119|NCT01786512|144343040|OTHER||Treatment difference|3.63|STANDARD_ERROR_OF_MEAN|1.57||0.0217|TWO_SIDED|95.0|0.53|6.72|||Repeated Measures||Repeated measures model includes treatment group, stratification factor, scheduled visit, interaction of treatment with scheduled visit and the baseline value as covariates.|||6.72|0.53|0.0217
72416120|NCT01786512|144343041|OTHER||Treatment difference|-0.079|STANDARD_ERROR_OF_MEAN|0.058||0.1732|TWO_SIDED|95.0|-0.194|0.035|||Repeated Measures||Repeated measures model includes treatment group, stratification factor, scheduled visit, interaction of treatment with scheduled visit and the baseline value as covariates.|||0.035|-0.194|0.1732
72416121|NCT01786512|144343041|OTHER||Treatment difference|-0.179|STANDARD_ERROR_OF_MEAN|0.059||0.0027|TWO_SIDED|95.0|-0.295|-0.062|||Repeated Measures||Repeated measures model includes treatment group, stratification factor, scheduled visit, interaction of treatment with scheduled visit and the baseline value as covariates.|||-0.062|-0.295|0.0027
72416122|NCT01786512|144343042|OTHER||Treatment difference|-0.067|STANDARD_ERROR_OF_MEAN|0.051||0.1899|TWO_SIDED|95.0|-0.166|0.033|||Repeated Measures||Repeated measures model includes treatment group, stratification factor, scheduled visit, interaction of treatment with scheduled visit and the baseline value as covariates.|||0.033|-0.166|0.1899
72416123|NCT01786512|144343042|OTHER||Treatment difference|-0.129|STANDARD_ERROR_OF_MEAN|0.052||0.0128|TWO_SIDED|95.0|-0.231|-0.028|||Repeated Measures||Repeated measures model includes treatment group, stratification factor, scheduled visit, interaction of treatment with scheduled visit and the baseline value as covariates.|||-0.028|-0.231|0.0128
72416124|NCT01786512|144343043|OTHER||Treatment difference|-1.34|STANDARD_ERROR_OF_MEAN|1.09||0.2177|TWO_SIDED|95.0|-3.47|0.79|||Repeated Measures||Repeated measures model includes treatment group, stratification factor, scheduled visit, interaction of treatment with scheduled visit and the baseline value as covariates.|||0.79|-3.47|0.2177
72600656|NCT04227405|144730305|SUPERIORITY||Slope|1.42|STANDARD_ERROR_OF_MEAN|0.41|<|0.01|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||Changes from pre-test to post-test in the intervention group were significantly different from the change from pre-test to post-test in the control group|Difference between the control and the intervention group in the change from Pre-test to Post-test||||<.01
72416125|NCT01786512|144343043|OTHER||Treatment difference|-2.97|STANDARD_ERROR_OF_MEAN|1.09||0.007|TWO_SIDED|95.0|-5.12|-0.81|||Repeated Measures||Repeated measures model includes treatment group, stratification factor, scheduled visit, interaction of treatment with scheduled visit and the baseline value as covariates.|||-0.81|-5.12|0.0070
72416126|NCT01786512|144343044|OTHER||Treatment difference|-822.0|STANDARD_ERROR_OF_MEAN|353.0||0.0205|TWO_SIDED|95.0|-1516.0|-127.0|||Repeated Measures||Repeated measures model includes treatment group, stratification factor, scheduled visit, interaction of treatment with scheduled visit and the baseline value as covariates.|||-127|-1516|0.0205
72416127|NCT01786512|144343044|OTHER||Treatment difference|-970.0|STANDARD_ERROR_OF_MEAN|357.0||0.0069|TWO_SIDED|95.0|-1672.0|-268.0|||Repeated Measures||Repeated measures model includes treatment group, stratification factor, scheduled visit, interaction of treatment with scheduled visit and the baseline value as covariates.|||-268|-1672|0.0069
72416128|NCT00605293|144343058|SUPERIORITY_OR_OTHER|||||||0.4778|||||||Fisher Exact|||||||0.4778
72416129|NCT02858050|144343092|OTHER|||||||0.548306|||||||Chi-squared|||||||0.548306
72416130|NCT03561090|144343093|SUPERIORITY||Least squares (LS) mean difference|0.055||||0.6346|TWO_SIDED|95.0|-0.172|0.281|||MMRM||Treatment difference (IW-3718 - placebo)|Treatment difference calculated as least squares mean (LSM) change from baseline at Week 8; IW-3718 - placebo based on an mixed models repeated measures (MMRM) model with week (categorical), treatment group, week-by-treatment group, and week-by-baseline value interactions, baseline esophagitis status (present vs. not present), and baseline WHSS (\< 3 vs. ≥ 3) as fixed effect terms and baseline value as a covariate, with subject as a random effect. An unstructured covariance structure was used.||0.281|-0.172|0.6346
72416131|NCT03561090|144343094|SUPERIORITY||LS Mean Difference|0.035||||0.7101|TWO_SIDED|95.0|-0.151|0.221|||MMRM||Treatment difference (IW-3718 - placebo)|Treatment difference calculated as LSM change from baseline at Week 8; IW-3718 - placebo based on an MMRM model with week (categorical), treatment group, week-by-treatment group, and week-by-baseline value interactions, baseline esophagitis status (present vs. not present), and baseline WHSS (\< 3 vs. ≥ 3) as fixed effect terms and baseline value as a covariate, with subject as a random effect. An unstructured covariance structure was used.||0.221|-0.151|0.7101
72416132|NCT03561090|144343095|SUPERIORITY||Difference in percentage of responders|-5.5|||||TWO_SIDED|95.0|-14.7|3.7|||||95% confidence interval (CI) for Difference in Responder Rates is obtained using the Newcombe CI.|||3.7|-14.7|
72600657|NCT04227405|144730305|SUPERIORITY||Slope|0.22|STANDARD_ERROR_OF_MEAN|0.35|>|0.05|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from pre-test to post-test for the control group for the Common Dyadic Coping Subscale||||>.05
72600658|NCT04227405|144730305|SUPERIORITY||Slope|2.12|STANDARD_ERROR_OF_MEAN|0.45|<|0.001|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from pre-test to post-test for the intervention group in the Common Dyadic Coping Subscale||||<.001
72600659|NCT04227405|144730305|SUPERIORITY||Slope|1.91|STANDARD_ERROR_OF_MEAN|0.55|<|0.01|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||Changes from pre-test to post-test in the intervention group were significantly different from the change from pre-test to post-test in the control group|Difference between the control and the intervention group in the change from Pre-test to Post-test inn the Common Dyadic Coping subscale||||<.01
72600660|NCT04227405|144730305|SUPERIORITY||Slope|-0.68|STANDARD_ERROR_OF_MEAN|0.42|>|0.05|TWO_SIDED|||||No adjustment in p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from pre-test to post-test for the control group for the Negative Dyadic Coping Scale||||>.05
72600661|NCT04227405|144730305|SUPERIORITY||Slope|-1.02|STANDARD_ERROR_OF_MEAN|0.53|<|0.1|TWO_SIDED|||||No adjustment in p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from pre-test to post-test for the intervention group for the Negative Dyadic Coping Scale||||<.10
72600662|NCT04227405|144730305|SUPERIORITY||Slope|-0.34|STANDARD_ERROR_OF_MEAN|0.65|>|0.05|TWO_SIDED|||||No adjustment in p value|Multilevel modeling||Changes from pre-test to post-test in the intervention group were not significantly different from the change from pre-test to post-test in the control group|Difference between the control and the intervention group in the change from Pre-test to Post-test for the Negative Dyadic Coping Subscale||||>.05
72600663|NCT03372382|144730334|EQUIVALENCE|We prespecified an equivalence margin of -10 to 10mm. We would consider non-opioid analgesia to be equivalent to opioid analgesia if the pain score mean difference between the groups and it's 95% confidence interval (CI) were within the prespecified margin. Pain score mean difference or 95% CI boundaries outside this range would be considered a clinically important difference between treatments|Mean Difference (Final Values)|4.8|||||TWO_SIDED|95.0|-2.1|11.9|||||The upper boundary of the CI is out of pre-specified limits.|Sample size calculations were based on VAS pain score at 2-4 weeks, assuming a mean of 10mm and standard deviation (SD) of 20 mm in the opioid group Assuming a two-sided alpha level of 0.05 and 80% power to detect equivalence, a total of 138 participants would be needed. To account for a 25% expected attrition rate and crossover, a total of 170 participants would be needed.||11.9|-2.1|
72600664|NCT02757352|144730336|SUPERIORITY||Odds Ratio (OR)|2.36||||0.009|TWO_SIDED|95.0|1.23|4.51|||Regression, Logistic|||||4.51|1.23|0.009
72600665|NCT02757352|144730336|SUPERIORITY||Odds Ratio (OR)|2.78||||0.002|TWO_SIDED|95.0|1.48|5.25|||Regression, Logistic|||||5.25|1.48|0.002
72600666|NCT02757352|144730337|SUPERIORITY||Odds Ratio (OR)|2.82||||0.004|TWO_SIDED|95.0|1.38|5.77|||Regression, Logistic|||||5.77|1.38|0.004
72600667|NCT02757352|144730337|SUPERIORITY||Odds Ratio (OR)|2.85||||0.004|TWO_SIDED|95.0|1.4|5.77|||Regression, Logistic|||||5.77|1.40|0.004
72600668|NCT02757352|144730338|SUPERIORITY||LS Mean Difference|-0.54|STANDARD_ERROR_OF_MEAN|0.136|<|0.001|TWO_SIDED|95.0|-0.81|-0.28|||Mixed Models Analysis|||||-0.28|-0.81|<0.001
72600669|NCT02757352|144730338|SUPERIORITY||LS Mean Difference|-0.68|STANDARD_ERROR_OF_MEAN|0.134|<|0.001|TWO_SIDED|95.0|-0.94|-0.41|||Mixed Models Analysis|||||-0.41|-0.94|<0.001
72600670|NCT02757352|144730339|SUPERIORITY||LS Mean Difference|-0.61|STANDARD_ERROR_OF_MEAN|0.179|<|0.001|TWO_SIDED|95.0|-0.96|-0.26|||Mixed Models Analysis|||||-0.26|-0.96|<0.001
72600671|NCT02757352|144730339|SUPERIORITY||LS Mean Difference|-0.69|STANDARD_ERROR_OF_MEAN|0.178|<|0.001|TWO_SIDED|95.0|-1.05|-0.34|||Mixed Models Analysis|||||-0.34|-1.05|<0.001
72600672|NCT02757352|144730341|SUPERIORITY||LS Mean Difference|2.8509|STANDARD_ERROR_OF_MEAN|1.139||0.013|TWO_SIDED|95.0|0.6092|5.0926|||Mixed Models Analysis|||||5.0926|0.6092|0.013
72600673|NCT02757352|144730341|SUPERIORITY||LS Mean Difference|2.7497|STANDARD_ERROR_OF_MEAN|1.1278||0.015|TWO_SIDED|95.0|0.5299|4.9694|||Mixed Models Analysis|||||4.9694|0.5299|0.015
72600674|NCT02757352|144730342|SUPERIORITY||LS Mean Difference|4.2001|STANDARD_ERROR_OF_MEAN|1.6467||0.012|TWO_SIDED|95.0|0.9525|7.4477|||Mixed Models Analysis|||||7.4477|0.9525|0.012
72600675|NCT02757352|144730342|SUPERIORITY||LS Mean Difference|4.6081|STANDARD_ERROR_OF_MEAN|1.6455||0.006|TWO_SIDED|95.0|1.3629|7.8533|||Mixed Models Analysis|||||7.8533|1.3629|0.006
72600676|NCT02757352|144730343|SUPERIORITY||Odds Ratio (OR)|2.73||||0.008|TWO_SIDED|95.0|1.3|5.76|||Regression, Logistic|||||5.76|1.30|0.008
72600677|NCT02757352|144730343|SUPERIORITY||Odds Ratio (OR)|3.43|||<|0.001|TWO_SIDED|95.0|1.66|7.08|||Regression, Logistic|||||7.08|1.66|<0.001
72600678|NCT02757352|144730344|SUPERIORITY||Odds Ratio (OR)|4.58|||<|0.001|TWO_SIDED|95.0|2.02|10.41|||Regression, Logistic|||||10.41|2.02|<0.001
72600679|NCT02757352|144730344|SUPERIORITY||Odds Ratio (OR)|3.99|||<|0.001|TWO_SIDED|95.0|1.76|9.05|||Regression, Logistic|||||9.05|1.76|<0.001
72600680|NCT02757352|144730345|SUPERIORITY||LS Means Square Difference|-0.67|STANDARD_ERROR_OF_MEAN|0.308||0.031|TWO_SIDED|95.0|-1.28|-0.06|||Mixed Models Analysis|||||-0.06|-1.28|0.031
72600681|NCT02757352|144730345|SUPERIORITY||LS Mean Difference|-1.01|STANDARD_ERROR_OF_MEAN|0.305||0.001|TWO_SIDED|95.0|-1.61|-0.41|||Mixed Models Analysis|||||-0.41|-1.61|0.001
72600682|NCT02757352|144730346|SUPERIORITY||LS Mean Difference|-1.13|STANDARD_ERROR_OF_MEAN|0.404||0.006|TWO_SIDED|95.0|-1.92|-0.33|||Mixed Models Analysis|||||-0.33|-1.92|0.006
72600683|NCT02757352|144730346|SUPERIORITY||LS Mean Difference|-1.29|STANDARD_ERROR_OF_MEAN|0.404||0.002|TWO_SIDED|95.0|-2.08|-0.49|||Mixed Models Analysis|||||-0.49|-2.08|0.002
72600684|NCT02757352|144730347|SUPERIORITY||LS Mean Difference|-3.07|STANDARD_ERROR_OF_MEAN|0.764|<|0.001|TWO_SIDED|95.0|-4.58|-1.57|||ANCOVA|||||-1.57|-4.58|<0.001
72600685|NCT02757352|144730347|SUPERIORITY||LS Mean Difference|-4.2|STANDARD_ERROR_OF_MEAN|0.751|<|0.001|TWO_SIDED|95.0|-5.68|-2.72|||ANCOVA|||||-2.72|-5.68|<0.001
72600686|NCT02757352|144730348|SUPERIORITY||LS Mean Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.621||0.849|TWO_SIDED|95.0|-1.35|1.11|||Mixed Models Analysis|||||1.11|-1.35|0.849
72600687|NCT02757352|144730348|SUPERIORITY||LS Mean Difference|-0.28|STANDARD_ERROR_OF_MEAN|0.608||0.648|TWO_SIDED|95.0|-1.48|0.93|||Mixed Models Analysis|||||0.93|-1.48|0.648
72600688|NCT02757352|144730349|SUPERIORITY||LS Mean Difference|-1.06|STANDARD_ERROR_OF_MEAN|0.443||0.018|TWO_SIDED|95.0|-1.93|-0.18|||Mixed Models Analysis|||||-0.18|-1.93|0.018
72600689|NCT02757352|144730349|SUPERIORITY||LS Mean Difference|-1.18|STANDARD_ERROR_OF_MEAN|0.442||0.008|TWO_SIDED|95.0|-2.05|-0.31|||Mixed Models Analysis|||||-0.31|-2.05|0.008
72600690|NCT02757352|144730350|SUPERIORITY||Odds Ratio (OR)|5.33||||0.0011|TWO_SIDED|96.0|1.47|19.4|||Regression, Logistic|||||19.40|1.47|0.0011
72600691|NCT02757352|144730350|SUPERIORITY||Odds Ratio (OR)|4.22||||0.031|TWO_SIDED|95.0|1.14|15.66|||Regression, Logistic|||||15.66|1.14|0.031
72600692|NCT02757352|144730351|SUPERIORITY||LS Mean Difference|-3.807|STANDARD_ERROR_OF_MEAN|2.8507||0.183|TWO_SIDED|95.0|-9.418|1.804|||Mixed Models Analysis|||||1.804|-9.418|0.183
72600693|NCT02757352|144730351|SUPERIORITY||LS Mean Difference|-2.743|STANDARD_ERROR_OF_MEAN|2.8202||0.331|TWO_SIDED|95.0|-8.294|2.807|||Mixed Models Analysis|||||2.807|-8.294|0.331
72600694|NCT02757352|144730352|SUPERIORITY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.148||0.008|TWO_SIDED|95.0|-0.69|-0.1|||Mixed Models Analysis|||||-0.10|-0.69|0.008
72600695|NCT02757352|144730352|SUPERIORITY||LS Mean Difference|-0.31|STANDARD_ERROR_OF_MEAN|0.148||0.038|TWO_SIDED|95.0|-0.6|-0.02|||Mixed Models Analysis|||||-0.02|-0.60|0.038
72600696|NCT02757352|144730353|SUPERIORITY||LS Mean Difference|0.05|STANDARD_ERROR_OF_MEAN|0.325||0.871|TWO_SIDED|95.0|-0.59|0.7|||Mixed Models Analysis|||||0.70|-0.59|0.871
72600697|NCT02757352|144730353|SUPERIORITY||LS Mean Difference|0.34|STANDARD_ERROR_OF_MEAN|0.327||0.295|TWO_SIDED|95.0|-0.3|0.99|||Mixed Models Analysis|||||0.99|-0.30|0.295
72600698|NCT02757352|144730354|SUPERIORITY||LS Mean Difference|-0.46|STANDARD_ERROR_OF_MEAN|0.406||0.257|TWO_SIDED|95.0|-1.26|0.34|||Mixed Models Analysis|||||0.34|-1.26|0.257
72600699|NCT02757352|144730354|SUPERIORITY||LS Mean Difference|-0.77|STANDARD_ERROR_OF_MEAN|0.402||0.057|TWO_SIDED|95.0|-1.56|0.02|||Mixed Models Analysis|||||0.02|-1.56|0.057
72600700|NCT02757352|144730355|SUPERIORITY||LS Mean Difference|-0.87|STANDARD_ERROR_OF_MEAN|0.496||0.082|TWO_SIDED|95.0|-1.85|0.11|||Mixed Models Analysis|||||0.11|-1.85|0.082
72600701|NCT02757352|144730355|SUPERIORITY||LS Mean Difference|-0.85|STANDARD_ERROR_OF_MEAN|0.493||0.088|TWO_SIDED|95.0|-1.82|0.13|||Mixed Models Analysis|||||0.13|-1.82|0.088
72600702|NCT02757352|144730356|SUPERIORITY||LS Mean Difference|-1.79|STANDARD_ERROR_OF_MEAN|1.442||0.219|TWO_SIDED|95.0|-4.66|1.09|||Mixed Models Analysis|||TJC||1.09|-4.66|0.219
72600703|NCT02757352|144730356|SUPERIORITY||LS Mean Difference|-3.53|STANDARD_ERROR_OF_MEAN|1.388||0.013|TWO_SIDED|95.0|-6.3|-0.76|||Mixed Models Analysis|||TJC||-0.76|-6.30|0.013
72600704|NCT02757352|144730356|SUPERIORITY||LS Mean Difference|-0.97|STANDARD_ERROR_OF_MEAN|0.355||0.009|TWO_SIDED|95.0|-1.68|-0.26|||Mixed Models Analysis|||SJC||-0.26|-1.68|0.009
72600705|NCT02757352|144730356|SUPERIORITY||LS Mean Difference|-0.76|STANDARD_ERROR_OF_MEAN|0.348||0.034|TWO_SIDED|95.0|-1.46|-0.06|||Mixed Models Analysis|||SJC||-0.06|-1.46|0.034
72600706|NCT02757352|144730358|SUPERIORITY||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.5||0.325|TWO_SIDED|95.0|-1.5|0.5|||Mixed Models Analysis|||||0.5|-1.5|0.325
72600707|NCT02757352|144730358|SUPERIORITY||LS Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.5||0.206|TWO_SIDED|95.0|-1.6|0.4|||Mixed Models Analysis|||||0.4|-1.6|0.206
72600708|NCT02757352|144730359|SUPERIORITY||LS Mean Difference|-0.59|STANDARD_ERROR_OF_MEAN|0.601||0.33|TWO_SIDED|95.0|-1.77|0.6|||Mixed Models Analysis|||||0.60|-1.77|0.330
72600709|NCT02757352|144730359|SUPERIORITY||LS Mean Difference|-0.97|STANDARD_ERROR_OF_MEAN|0.602||0.11|TWO_SIDED|95.0|-2.15|0.22|||Mixed Models Analysis|||||0.22|-2.15|0.110
72600710|NCT02757352|144730360|SUPERIORITY||LS Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.81||0.348|TWO_SIDED|95.0|-2.4|0.8|||Mixed Models Analysis|||||0.8|-2.4|0.348
72600711|NCT02757352|144730360|SUPERIORITY||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.82||0.386|TWO_SIDED|95.0|-2.3|0.9|||Mixed Models Analysis|||||0.9|-2.3|0.386
72600712|NCT02757352|144730361|SUPERIORITY||LS Mean Difference|-13.76|STANDARD_ERROR_OF_MEAN|4.835||0.005|TWO_SIDED|95.0|-23.32|-4.2|||ANCOVA|||Overall Impairment Score||-4.20|-23.32|0.005
72600713|NCT02757352|144730361|SUPERIORITY||LS Mean Difference|-6.29|STANDARD_ERROR_OF_MEAN|4.697||0.183|TWO_SIDED|95.0|-15.58|3.0|||ANCOVA|||Overall Impairment Score||3.00|-15.58|0.183
72416133|NCT03561090|144343095|SUPERIORITY||Odds Ratio (OR)|0.81||||0.2531|TWO_SIDED|95.0|0.56|1.17|||Cochran-Mantel-Haenszel||Odds Ratio for Response (IW-3718 : placebo)|Treatment difference was calculated as the difference in the responder rates at Week 8; IW-3718 - placebo. The 95% CI for the difference in the responder rates was obtained using the Newcombe CI. P value was based on the odds ratio for the response rate (IW-3718:placebo) obtained from the CMH tests controlling for baseline esophagitis status and baseline heartburn severity level (\< 3 vs. ≥ 3).||1.17|0.56|0.2531
72600714|NCT02757352|144730361|SUPERIORITY||LS Mean Difference|-5.9|STANDARD_ERROR_OF_MEAN|3.114||0.06|TWO_SIDED|95.0|-12.05|0.26|||ANCOVA|||Percentage of absenteeism||0.26|-12.05|0.060
72600715|NCT02757352|144730361|SUPERIORITY||LS Mean Difference|-4.15|STANDARD_ERROR_OF_MEAN|3.098||0.182|TWO_SIDED|95.0|-10.27|1.97|||ANCOVA|||Percentage of absenteeism||1.97|-10.27|0.182
72600716|NCT02757352|144730361|SUPERIORITY||LS Mean Difference|-13.61|STANDARD_ERROR_OF_MEAN|4.558||0.003|TWO_SIDED|95.0|-22.62|-4.6|||ANCOVA|||Percentage of presentism||-4.60|-22.62|0.003
72600717|NCT02757352|144730361|SUPERIORITY||LS Mean Difference|-6.21|STANDARD_ERROR_OF_MEAN|4.446||0.164|TWO_SIDED|95.0|-15.0|2.58|||ANCOVA|||Percentage of presentism||2.58|-15.00|0.164
72600718|NCT02757352|144730361|SUPERIORITY||LS Mean Difference|-10.63|STANDARD_ERROR_OF_MEAN|3.669||0.004|TWO_SIDED|95.0|-17.85|-3.41|||LS Mean Difference|||Percentage of Impairment in Activities Performed Outside of Work||-3.41|-17.85|0.004
72600719|NCT02757352|144730361|SUPERIORITY||LS Mean Difference|-9.99|STANDARD_ERROR_OF_MEAN|3.621||0.006|TWO_SIDED|95.0|-17.12|-2.86|||ANCOVA|||Percentage of Impairment in Activities Performed Outside of Work||-2.86|-17.12|0.006
72600720|NCT00802672|144730365|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|For the primary efficacy analysis, a 90% confidence interval was constructed for the difference in the Therapeutic Success rates between the Test Product and Reference Product at Visit 4/Week 6 (Follow-Up). The interval was calculated using Wald's method with Yates' continuity correction. Therapeutic equivalence (bioequivalence) was established if this 90% confidence interval was contained within the interval -0.20 to +0.20 (-0.20% to +0.20%)|Mean Difference (Final Values)|1.0|||||TWO_SIDED|90.0|-17.61|2.45|||Wald's method with Yates' continuity|||||2.45|-17.61|
72600721|NCT04656301|144730370|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|degrees of freedom = 1.92||||||<0.001
72600722|NCT01579669|144730421|SUPERIORITY_OR_OTHER|||||||0.0269|TWO_SIDED||||||t-test, 2 sided|||Pre-post comparison||||0.0269
72600723|NCT01579669|144730422|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||t-test, 2 sided|||Pre-post intervention comparison||||<0.0001
72600724|NCT01579669|144730423|SUPERIORITY_OR_OTHER|||||||0.016|TWO_SIDED||||||t-test, 2 sided|||Pre-post intervention comparison||||0.016
72600725|NCT00527124|144730424|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.907|STANDARD_ERROR_OF_MEAN|0.2973||0.7428|TWO_SIDED|95.0|0.506|1.624|||Regression, Cox|||||1.624|0.506|0.7428
72600726|NCT00527124|144730424|SUPERIORITY_OR_OTHER|||||||0.7425|TWO_SIDED|95.0|||||Log Rank|||||||0.7425
72600727|NCT00909220|144730453|SUPERIORITY||Mean Difference (Final Values)|0.42|STANDARD_ERROR_OF_MEAN|0.06||0.05|TWO_SIDED|95.0|0.27|0.49|||ANCOVA|||ANCOVA comparing groups (HEA v MDD), controlling for baseline depression (IDS-C score at week 0) to estimate depression at the end of treatment (IDS-C score at week 16).||0.49|0.27|0.05
72600728|NCT00909220|144730454|SUPERIORITY|ANCOVA|Mean Difference (Final Values)|0.39|STANDARD_ERROR_OF_MEAN|0.07|<|0.05|TWO_SIDED|95.0|0.31|0.59|||ANCOVA|||ANCOVA comparing groups (HEA v MDD), controlling for baseline depression (IDS-SR score at week 0) to estimate depression at the end of treatment (IDS-SR score at week 16).||0.59|0.31|<0.05
72600729|NCT00909220|144730455|OTHER|Multiple regression analyses|beta|0.43|STANDARD_ERROR_OF_MEAN|6.75||0.02|TWO_SIDED|||||p \<0.05 a priori threshold for statistical significance.|Regression, Linear|||||||.02
72600730|NCT00909220|144730456|OTHER|Hierarchical linear modeling (HLM) , an ordinary least square (OLS) regression-based analysis.|Slope|2.58|STANDARD_ERROR_OF_MEAN|0.75|<|0.05|TWO_SIDED|95.0|1.22|2.77||The variation of slopes among participants for each variable were calculated. If significant, a second level of analysis focused on predictors of the variation was conducted.|Regression, Logistic|df = 31||A two-level hierarchical linear model assessing the effects of negativity bias and positivity offset at pre-treatment on the rate of depression severity (IDS-SR) over 16 weeks of treatment (time). First level units were 'weeks in BA treatment', with participants limited to those who attended five or more therapy sessions, resulting in a total of 421 treatment weeks for analysis. Second-level units were the 'subjects entering BA treatment'.||2.77|1.22|<0.05
72600731|NCT02700425|144730491|OTHER||||||<|0.001||||||P-value was not adjusted for multiple comparisons. Test was two-tailed, considered statistically significant with a p-value \<0.05, and conducted using SAS version 9.4 (SAS Institute Inc, Cary, NC) and STATA MP version 15 (College Station, TX).|Sign test|Wilcoxon signed rank test||The sample size was estimated based on the primary endpoint of echocardiographic response to test the hypothesis that an absolute 10% greater improvement in LVEF would be observed with His Bundle Pacing compared to Coronary Sinus Pacing, with a significance level of 0.05 and a power of 0.80. Primary outcome was presented at baseline and 6-months as median (interquartile range) based upon the Shapiro-Wilks test of normality, and then analyzed with the Wilcoxon signed rank test.||||<0.001
72600732|NCT02700425|144730491|OTHER||||||<|0.001||||||P-value was not adjusted for multiple comparisons. Test was two-tailed, considered statistically significant with a p-value \<0.05, and conducted using SAS version 9.4 (SAS Institute Inc, Cary, NC) and STATA MP version 15 (College Station, TX).|Sign test|Wilcoxon signed rank test||The sample size was estimated based on the primary endpoint of echocardiographic response to test the hypothesis that an absolute 10% greater improvement in LVEF would be observed with His Bundle Pacing compared to Coronary Sinus Pacing, with a significance level of 0.05 and a power of 0.80. Primary outcome was presented at baseline and 6-months as median (interquartile range) based upon the Shapiro-Wilks test of normality, and then analyzed with the Wilcoxon signed rank test.||||<0.001
72416134|NCT03561090|144343096|SUPERIORITY||Proportion ratio|0.938||||0.7445|TWO_SIDED|95.0|0.636|1.382||Negative binomial model was used to deal with data overdispersion.|Negative binomial model||Proportion Ratio (1500 mg IW-3718 BID + PPI: Placebo + PPI)|Poisson regression including the fixed categorical effect of treatment, the baseline esophagitis status (present vs. not present) and baseline WHSS (\<3 vs. ≥3), the covariate of baseline proportion of heartburn-free days, and with the diary entry duration (in days) as a weight variable adjusted in the model was applied.||1.382|0.636|0.7445
72416135|NCT03561090|144343096|OTHER|Negative binomial model was used to deal with data overdispersion.|Difference in Proportion Ratio|-0.015|||||TWO_SIDED|95.0|-0.103|0.074|||||Difference in Proportion Ratio, (1500 mg IW-3718 BID + PPI) - (Placebo + PPI).|Poisson regression including the fixed categorical effect of treatment, the baseline esophagitis status (present vs. not present) and baseline WHSS (\<3 vs. ≥3), the covariate of baseline proportion of heartburn-free days, and with the diary entry duration (in days) as a weight variable adjusted in the model was applied.||0.074|-0.103|
72416136|NCT04162769|144343097|SUPERIORITY||Least square mean difference|-10.28|STANDARD_ERROR_OF_MEAN|6.605|=|0.1198|TWO_SIDED|95.0|-23.228|2.674|||ANCOVA|||Week 12||2.674|-23.228|=0.1198
72600733|NCT02700425|144730492|OTHER|paired t-test||||||0.002||||||P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05, and conducted using STATA MP version 15 (College Station, TX).|t-test, 2 sided|||Primary outcome was presented at baseline and 1-year as means +/- standard deviations based upon the Shapiro-Wilks test of normality, and then analyzed with paired t-tests.||||0.002
72600734|NCT02700425|144730492|OTHER|paired t-test||||||0.002|||||||t-test, 2 sided|||Primary outcome of His Bundle Pacing was presented at baseline and 1-year as means +/- standard deviations based upon the Shapiro-Wilks test of normality, and then analyzed with paired t-tests.||||0.002
72600735|NCT02700425|144730493|OTHER|Log rank test of a survival analysis||||||0.62||||||P-value did not need to be adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05, and conducted using STATA MP version 15 (College Station, TX).|Log Rank|||Primary outcome of time to first cardiovascular hospitalization or death by His Bundle Pacing compared to Coronary Sinus Pacing presented median and interquartile range in years based upon the Shapiro-Wilks test of normality, and then analyzed with a log rank test.||||0.62
72600736|NCT02700425|144730494|OTHER|||||||0.09||||||P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05, and conducted using STATA MP version 15 (College Station, TX).|Sign test|Wilcoxon sign rank test||NYHA functional class of Coronary Sinus Pacing arm was presented at baseline as medians (interquartile ranges) based upon the Shapiro-Wilks test of normality, and then analyzed with a Wilcoxon sign rank test.||||0.09
72600737|NCT02700425|144730494|OTHER|||||||0.32||||||P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05, and conducted using STATA MP version 15 (College Station, TX).|Sign test|Wilcoxon sign rank test||NYHA functional class of the His Bundle Pacing arm was presented at baseline and 12 months as medians (interquartile ranges) based upon the Shapiro-Wilks test of normality, and then analyzed with Wilcoxon sign rank test.||||0.32
72416137|NCT04162769|144343097|SUPERIORITY||Least square mean difference|-8.77|STANDARD_ERROR_OF_MEAN|6.515|=|0.1783|TWO_SIDED|95.0|-21.544|4.002|||ANCOVA|||Week 12||4.002|-21.544|=0.1783
72416138|NCT04162769|144343098|SUPERIORITY||Response Rate Difference|-0.2|STANDARD_ERROR_OF_MEAN|9.34|=|0.9826|TWO_SIDED|95.0|-18.52|18.11|||Cochran-Mantel-Haenszel|||Week 12||18.11|-18.52|=0.9826
72416139|NCT04162769|144343098|SUPERIORITY||Response Rate Difference|13.0|STANDARD_ERROR_OF_MEAN|9.78|=|0.1891|TWO_SIDED|95.0|-6.12|32.21|||Cochran-Mantel-Haenszel|||Week 12||32.21|-6.12|=0.1891
72416140|NCT04162769|144343099|SUPERIORITY||Response Rate Difference|2.2|STANDARD_ERROR_OF_MEAN|7.38|=|0.7694|TWO_SIDED|95.0|-12.29|16.64|||Cochran-Mantel-Haenszel|||Week 12||16.64|-12.29|=0.7694
72600738|NCT02700425|144730495|OTHER|||||||0.35||||||P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05, and conducted using STATA MP version 15 (College Station, TX).|Sign test|||Quality of Life was presented at baseline and 1-year as medians (interquartile range) for patients with His Bundle Pacing based upon the Shapiro-Wilks test of normality, and then analyzed with Wilcoxon signed-rank test.||||0.35
72600739|NCT02700425|144730495|OTHER|||||||0.07||||||P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05, and conducted using STATA MP version 15 (College Station, TX).|Sign test|||Quality of Life was presented at baseline and 1-year as medians (interquartile range) for patients with Coronary Sinus Pacing based upon the Shapiro-Wilks test of normality, and then analyzed with Wilcoxon signed-rank test.||||0.07
72600740|NCT02700425|144730496|OTHER|Log rank test of a survival analysis||||||0.14||||||P-value did not need to be adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05, and conducted using STATA MP version 15 (College Station, TX).|Log Rank|||Primary outcome of time to first cardiovascular rehospitalization by His Bundle Pacing compared to Coronary Sinus Pacing presented median and interquartile range in years based upon the Shapiro-Wilks test of normality, and then analyzed with a log rank test.||||0.14
72600741|NCT02700425|144730497|OTHER|Log rank test of a survival analysis||||||0.14||||||P-value did not need to be adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05, and conducted using STATA MP version 15 (College Station, TX).|Log Rank|||Primary outcome of time to first treated VT/VF by His Bundle Pacing compared to Coronary Sinus Pacing presented median and interquartile range in years based upon the Shapiro-Wilks test of normality, and then analyzed with a log rank test.||||0.14
72600743|NCT01462305|144730567|SUPERIORITY_OR_OTHER|||||||0.74||||||interaction effect and week of treatment condition|ANOVA|||To test the hypothesis that depressed SAD patients would demonstrate greater antidepressant therapeutic benefit from the \~465nm (shorter wavelength) source compared with the \~595nm (longer wavelength) source, we conducted a repeated-measures ANOVA using PROC MIXED in SAS 9.3 with treatment (\~465nm vs. \~595nm) as a between-subject factor and time (treatment visit 1, treatment visit 2, treatment visit 3, phone assessment 1, phone assessment 2, and treatment visit 4) as a within-subject factor.||||0.74
72600744|NCT01462305|144730567|SUPERIORITY_OR_OTHER|||||||0.9||||||A repeated-measures ANOVA on the 29 subjects revealed no significant effect or interaction effect|ANOVA|||||||0.9
72600745|NCT01462305|144730567|SUPERIORITY_OR_OTHER||||||<|0.0001||||||A repeated-measures ANOVA on the 29 subjects revealed significant effect of treatment week|ANOVA|||||||<0.0001
72600746|NCT01462305|144730569|SUPERIORITY_OR_OTHER|||||||0.2|TWO_SIDED||||||ANOVA|||||||0.20
72600747|NCT01690299|144730613|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|27.5|||<|0.0001|TWO_SIDED|95.0|14.9|40.1||The two-sided p-value is from a CMH test stratified by the BMI at screening.|Cochran-Mantel-Haenszel||The confidence interval (CI) is weighted using CMH weights according to the number of participants in the two strata.|||40.1|14.9|< 0.0001
72416141|NCT04162769|144343099|SUPERIORITY||Response Rate Difference|17.4|STANDARD_ERROR_OF_MEAN|8.47|=|0.045|TWO_SIDED|95.0|0.79|34.0|||Cochran-Mantel-Haenszel|||Week 12||34.00|0.79|=0.0450
72416142|NCT04162769|144343100|SUPERIORITY||Least square mean difference|-14.03|STANDARD_ERROR_OF_MEAN|7.295|=|0.0558|TWO_SIDED|95.0|-28.406|0.352|||Mixed Models Analysis|||Week 12||0.352|-28.406|=0.0558
72600748|NCT01690299|144730614|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|35.9|||<|0.0001|TWO_SIDED|95.0|23.3|48.5||The two-sided p-value is from a CMH test stratified by the BMI at screening.|Cochran-Mantel-Haenszel||The confidence interval (CI) is weighted using CMH weights according to the number of participants in the two strata.|||48.5|23.3|<0.0001
72600749|NCT01690299|144730615|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|18.0||||0.0005|TWO_SIDED|95.0|8.4|27.7||The p-value is from a CMH test stratified by the BMI (Body Mass Index) at screening.|Cochran-Mantel-Haenszel|The p-value is from a CMH test stratified by the BMI at screening.|The Confidence Interval (CI) was weighted using CMH weights according to the number of participants in the two strata.|||27.7|8.4|0.0005
72600750|NCT01690299|144730615|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|25.2|||<|0.0001|TWO_SIDED|95.0|14.8|35.5||The p-value is from a CMH test stratified by the BMI (Body Mass Index) at screening.|Cochran-Mantel-Haenszel|The Confidence Interval (CI) was weighted using CMH weights according to the number of participants in the two strata.||||35.5|14.8|<0.0001
72600751|NCT01690299|144730616|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Mean|-31.4|||<|0.0001|TWO_SIDED|95.0|-43.33|-19.46|||ANCOVA|Based on ANCOVA model with treatment and screening BMI category as factors and baseline value as a covariate.||||-19.46|-43.33|<0.0001
72600752|NCT01690299|144730616|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Mean|-39.85|||<|0.0001|TWO_SIDED|95.0|-51.78|-27.92|||ANCOVA|Based on ANCOVA model with treatment and screening BMI category as factors and baseline value as a covariate.||||-27.92|-51.78|<0.0001
72600753|NCT01690299|144730617|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|29.4||||0.0002|TWO_SIDED|95.0|14.9|43.9||The two-sided p-value is from a CMH test stratified by the BMI at screening.|Cochran-Mantel-Haenszel||The confidence interval (CI) is weighted using CMH weights according to the number of participants in the two strata.|||43.9|14.9|0.0002
72600754|NCT01690299|144730617|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|49.8|||<|0.0001|TWO_SIDED|95.0|36.9|62.7||The two-sided p-value is from a CMH test stratified by the BMI at screening.|Cochran-Mantel-Haenszel||The confidence interval (CI) is weighted using CMH weights according to the number of participants in the two strata.|||62.7|36.9|<0.0001
72600755|NCT01690299|144730618|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Mean|-4.48|||<|0.0001|TWO_SIDED|95.0|-6.82|-2.14|||ANCOVA|Based on ANCOVA model with treatment and screening BMI category as factors and baseline value as a covariate.||||-2.14|-6.82|<0.0001
72416143|NCT04162769|144343100|SUPERIORITY||Least square mean difference|-10.67|STANDARD_ERROR_OF_MEAN|7.134|=|0.1363|TWO_SIDED|95.0|-24.737|3.397|||Mixed Models Analysis|||Week 12||3.397|-24.737|=0.1363
72600756|NCT01690299|144730618|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Mean|-3.94||||0.0004|TWO_SIDED|95.0|-6.27|-1.6|||ANCOVA|Based on ANCOVA model with treatment and screening BMI category as factors and baseline value as a covariate.||||-1.60|-6.27|0.0004
72600757|NCT01690299|144730619|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Mean|0.93||||0.7112|TWO_SIDED|95.0|-2.05|3.9|||ANCOVA|Based on ANCOVA model with treatment and screening BMI category as factors and baseline value as a covariate.||||3.90|-2.05|0.7112
72600758|NCT01690299|144730619|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Mean|2.22||||0.1719|TWO_SIDED|95.0|-0.75|5.19|||ANCOVA|Based on ANCOVA model with treatment and screening BMI category as factors and baseline value as a covariate.||||5.19|-0.75|0.1719
72600759|NCT01690299|144730620|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|18.1||||0.0011|TWO_SIDED|95.0|7.6|28.6||The two-sided p-value is from a CMH test stratified by the BMI at screening.|Cochran-Mantel-Haenszel||The confidence interval (CI) is weighted using CMH weights according to the number of participants in the two strata.|||28.6|7.6|0.0011
72600760|NCT01690299|144730620|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|16.7||||0.0021|TWO_SIDED|95.0|6.5|26.9||The two-sided p-value is from a CMH test stratified by the BMI at screening.|Cochran-Mantel-Haenszel||The confidence interval (CI) is weighted using CMH weights according to the number of participants in the two strata.|||26.9|6.5|0.0021
72600761|NCT01753115|144730625|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Equivalence margin is 0.80 - 1.25.|Ratio of AUC|0.887|||||TWO_SIDED|90.0|0.831|0.948||||||Analysis of Ciprofloxacin Area Under the Curve at Day 5 and Day 44.||0.948|0.831|
72600762|NCT01753115|144730625|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Equivalence margin is 0.80 - 1.25.|Ratio of Cmax|0.944|||||TWO_SIDED|90.0|0.852|1.046||||||Analysis of Cmax at Day 5 and Day 44||1.046|0.852|
72416144|NCT04162769|144343101|SUPERIORITY||Response Rate Difference|4.2|STANDARD_ERROR_OF_MEAN|11.33|=|0.7143|TWO_SIDED|95.0|-18.0|26.41|||Cochran-Mantel-Haenszel|||Week 12||26.41|-18.00|=0.7143
72416145|NCT04162769|144343101|SUPERIORITY||Response Rate Difference|5.1|STANDARD_ERROR_OF_MEAN|11.09|=|0.6488|TWO_SIDED|95.0|-16.62|26.87|||Cochran-Mantel-Haenszel|||Week 12||26.87|-16.62|=0.6488
72416146|NCT04162769|144343102|SUPERIORITY||Response Rate Difference|8.8|STANDARD_ERROR_OF_MEAN|10.22|=|0.3981|TWO_SIDED|95.0|-11.27|28.8|||Cochran-Mantel-Haenszel|||Week 12||28.80|-11.27|=0.3981
72600763|NCT01753115|144730626|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority margin is 0.67.|Ratio of GMT|1.267|||||TWO_SIDED|95.0|0.898|1.787||||||||1.787|0.898|
72600764|NCT00519584|144730632|SUPERIORITY||Hazard Ratio (HR)|0.17|||<|0.001|TWO_SIDED|95.0|0.08|0.39|||Log Rank||Ropivacaine/dex vs. Ropivacaine/saline|||0.39|0.08|<0.001
72600765|NCT00519584|144730632|SUPERIORITY||Hazard Ratio (HR)|0.44|||<|0.001|TWO_SIDED|95.0|0.23|0.83|||Log Rank||bupivacaine/dex vs. bupivacaine/Saline|||0.83|0.23|<0.001
72600766|NCT00519584|144730633|SUPERIORITY||||||<|0.001|||||||Log Rank|||||||<0.001
72600767|NCT00519584|144730633|SUPERIORITY||||||<|0.001|||||||Log Rank|||||||<0.001
72600768|NCT00519584|144730634|SUPERIORITY||||||<|0.001||||||adjusted significance level is 0.025|Wilcoxon (Mann-Whitney)|||||||<0.001
72600769|NCT00519584|144730634|SUPERIORITY|||||||0.005|||||||Wilcoxon (Mann-Whitney)|||||||0.005
72600770|NCT00519584|144730635|SUPERIORITY|||||||0.29||||||adjusted significance level = 0.025|Wilcoxon (Mann-Whitney)|||||||0.29
72600771|NCT00519584|144730635|SUPERIORITY|||||||0.15||||||adjusted significance level = 0.025|Wilcoxon (Mann-Whitney)|||||||0.15
72600772|NCT00524680|144730661|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||t-test, 2 sided|||Change from Baseline in Serum 25(OH) D3 Levels at 1-Month for dose level 4000 IU. Statistical analysis was done using one sample t-test.||||<.0001
72600773|NCT00524680|144730661|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||t-test, 2 sided|||Change from Baseline in Serum 25(OH) D3 Levels at 3-Month for dose level 4000 IU. Statistical analysis was done using one sample t-test.||||<.0001
72600774|NCT00524680|144730661|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||t-test, 2 sided|||Change from Baseline in Serum 25(OH) D3 Levels at 6-Month for dose level 4000 IU. Statistical analysis was done using one sample t-test.||||<.0001
72600775|NCT00524680|144730661|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||t-test, 2 sided|||Change from Baseline in Serum 25(OH) D3 Levels at 1-Month for dose level 6000 IU. Statistical analysis was done using one sample t-test.||||<.0001
72600776|NCT00524680|144730661|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||t-test, 2 sided|||Change from Baseline in Serum 25(OH) D3 Levels at 3-Month for dose level 6000 IU. Statistical analysis was done using one sample t-test.||||<.0001
72600777|NCT00524680|144730661|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||t-test, 2 sided|||Change from Baseline in Serum 25(OH) D3 Levels at 6-Month for dose level 6000 IU. Statistical analysis was done using one sample t-test.||||<.0001
72600778|NCT00524680|144730661|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||t-test, 2 sided|||Change from Baseline in Serum 25(OH) D3 Levels at 1-Month for dose level 8000 IU. Statistical analysis was done using one sample t-test.||||<.0001
72600779|NCT00524680|144730661|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||t-test, 2 sided|||Change from Baseline in Serum 25(OH) D3 Levels at 3-Month for dose level 8000 IU. Statistical analysis was done using one sample t-test.||||<.0001
72600780|NCT00524680|144730661|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||t-test, 2 sided|||Change from Baseline in Serum 25(OH) D3 Levels at 6-Month for dose level 8000 IU. Statistical analysis was done using one sample t-test.||||<.0001
72600781|NCT00524680|144730661|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||t-test, 2 sided|||Change from Baseline in Serum 25(OH) D3 Levels at 1-Month for dose level 10000 IU. Statistical analysis was done using one sample t-test.||||<.0001
72600782|NCT00524680|144730661|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||t-test, 2 sided|||Change from Baseline in Serum 25(OH) D3 Levels at 3-Month for dose level 10000 IU. Statistical analysis was done using one sample t-test.||||<.0001
72600783|NCT00524680|144730661|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||t-test, 2 sided|||Change from Baseline in Serum 25(OH) D3 Levels at 6-Month for dose level 10000 IU. Statistical analysis was done using one sample t-test.||||<.0001
72600784|NCT00524680|144730662|SUPERIORITY_OR_OTHER|||||||0.8244|TWO_SIDED||||||t-test, 2 sided|||Change from Baseline in PTH Levels at 1-month for 4000 IU. Statistical analysis was done using one sample t-test.||||0.8244
72600785|NCT00524680|144730662|SUPERIORITY_OR_OTHER|||||||0.1025|TWO_SIDED||||||t-test, 2 sided|||Change from Baseline in PTH Levels at 3-month for 4000 IU. Statistical analysis was done using one sample t-test.||||0.1025
72600786|NCT00524680|144730662|SUPERIORITY_OR_OTHER|||||||0.1744|TWO_SIDED||||||t-test, 2 sided|||Change from Baseline in PTH Levels at 6-Month for dose level 4000 IU.||||0.1744
72600787|NCT00524680|144730662|SUPERIORITY_OR_OTHER|||||||0.1281|TWO_SIDED||||||t-test, 2 sided|||Change from Baseline in PTH Levels at 1-month for 6000 IU. Statistical analysis was done using one sample t-test.||||0.1281
72600788|NCT00524680|144730662|SUPERIORITY_OR_OTHER|||||||0.9688|TWO_SIDED||||||t-test, 2 sided|||Change from Baseline in PTH Levels at 3-month for 6000 IU. Statistical analysis was done using one sample t-test.||||0.9688
72600789|NCT00524680|144730662|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||t-test, 2 sided|||Change from Baseline in PTH Levels at 6-month for 6000 IU. Statistical analysis was done using one sample t-test.||||<0.0001
72600790|NCT00524680|144730662|SUPERIORITY_OR_OTHER|||||||0.8241|TWO_SIDED||||||t-test, 2 sided|||Change from Baseline in PTH Levels at 1-month for 8000 IU. Statistical analysis was done using one sample t-test.||||0.8241
72600791|NCT00524680|144730662|SUPERIORITY_OR_OTHER|||||||0.1828|TWO_SIDED||||||t-test, 2 sided|||Change from Baseline in PTH Levels at 3-month for 8000 IU. Statistical analysis was done using one sample t-test.||||0.1828
72600792|NCT00524680|144730662|SUPERIORITY_OR_OTHER|||||||0.1348|TWO_SIDED||||||t-test, 2 sided|||Change from Baseline in PTH Levels at 6-month for 8000 IU. Statistical analysis was done using one sample t-test.||||0.1348
72600793|NCT00524680|144730662|SUPERIORITY_OR_OTHER|||||||0.2214|TWO_SIDED||||||t-test, 2 sided|||Change from Baseline in PTH Levels at 1-month for 10000 IU. Statistical analysis was done using one sample t-test.||||0.2214
72600794|NCT00524680|144730662|SUPERIORITY_OR_OTHER|||||||0.0079|TWO_SIDED||||||t-test, 2 sided|||Change from Baseline in PTH Levels at 3-month for 10000 IU. Statistical analysis was done using one sample t-test.||||0.0079
72600795|NCT00524680|144730662|SUPERIORITY_OR_OTHER|||||||0.0631|TWO_SIDED||||||t-test, 2 sided|||Change from Baseline in PTH Levels at 6-month for 10000 IU. Statistical analysis was done using one sample t-test.||||0.0631
72600796|NCT03124537|144730665|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|Controlling for age, sex, condition, education, and health||Tested whether weekly steps increased from the baseline week in both conditions (main effect of time).||||< .001
72600797|NCT03124537|144730665|SUPERIORITY|||||||0.846||||||Controlling for age, sex, education, and health.|Mixed Models Analysis|||Tested whether weekly step increases from the baseline week differed between the two conditions (time by condition interaction).||||.846
72600798|NCT03124537|144730666|SUPERIORITY|||||||0.571||||||Controlling for age, sex, condition, education, and health.|Mixed Models Analysis|||Tested whether exercise self-efficacy increased from the baseline week to the end of the intervention in both conditions (main effect of time).||||.571
72600799|NCT03124537|144730666|SUPERIORITY|||||||0.361|||||||Mixed Models Analysis|Controlling for age, sex, education, and health.||Tested whether exercise self efficacy increases from the baseline to the end of the intervention differed between the two conditions (time by condition interaction).||||.361
72600800|NCT03124537|144730667|SUPERIORITY|||||||0.564|||||||Mixed Models Analysis|Controlling for age, sex, condition, education, and health.||Tested whether exercise control increased from the baseline week to the end of the intervention in both conditions (main effect of time).||||.564
72600801|NCT03124537|144730667|SUPERIORITY|||||||0.641|||||||Mixed Models Analysis|Controlling for age, sex, education, and health.||Tested whether exercise control belief increases from the baseline to the end of the intervention differed between the two conditions (time by condition interaction).||||.641
72600802|NCT03124537|144730669|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|Controlling for age, sex, condition, education, health, and average steps.||Tested whether daily walking was related to mood within-persons.||||< .001
72600803|NCT03124537|144730669|SUPERIORITY|||||||0.003|||||||Mixed Models Analysis|Controlling for age, condition, education, health, and average steps.||Tested whether daily walking was related to energy within-persons.||||.003
72600804|NCT03124537|144730669|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|Controlling for age, sex, condition, education, health, and average steps.||Tested whether the relationship between daily walking and mood differed between males and females (steps by sex interaction).||||< .001
72600805|NCT03124537|144730669|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|Controlling for age, condition, education, health, and average steps.||Tested whether the relationship between daily walking and energy differed between males and females (steps by sex interaction).||||< .001
72600806|NCT03124537|144730670|SUPERIORITY|||||||0.011|||||||Mixed Models Analysis|Controlling for age, sex, condition, education, and health.||Tested whether self-reported vigorous physical activity increased from the baseline week to the end of the intervention in both conditions (main effect of time).||||.011
72600807|NCT03124537|144730670|SUPERIORITY|||||||0.232|||||||Mixed Models Analysis|Controlling for age, sex, education, and health.||Tested whether self-reported vigorous physical activity increases from the baseline to the end of the intervention differed between the two conditions (time by condition interaction).||||.232
72600808|NCT03124537|144730671|SUPERIORITY|||||||0.53|||||||Mixed Models Analysis|Controlling for age, sex, condition, education, and health.||Tested whether self-reported moderate physical activity increased from the baseline week to the end of the intervention in both conditions (main effect of time).||||.530
72600809|NCT03124537|144730671|SUPERIORITY|||||||0.831|||||||Mixed Models Analysis|Controlling for age, sex, education, and health.||Tested whether self-reported moderate physical activity increases from the baseline to the end of the intervention differed between the two conditions (time by condition interaction).||||.831
72600810|NCT03124537|144730672|SUPERIORITY|||||||0.199|||||||Mixed Models Analysis|Controlling for age, sex, condition, education, and health.||Tested whether self-reported light physical activity increased from the baseline week to the end of the intervention in both conditions (main effect of time).||||.199
72600811|NCT03124537|144730672|SUPERIORITY|||||||0.203|||||||Mixed Models Analysis|Controlling for age, sex, education, and health.||Tested whether self-reported light physical activity increases from the baseline to the end of the intervention differed between the two conditions (time by condition interaction).||||.203
72600812|NCT00856843|144730696|SUPERIORITY_OR_OTHER||Difference in success rates|8.8||||0.038|TWO_SIDED|95.0|0.9|16.8|||Chi-squared|||||16.8|0.9|0.038
72600813|NCT00856843|144730697|SUPERIORITY_OR_OTHER|||||||0.01|||||||Chi-squared|||||||0.010
72600814|NCT00856843|144730698|SUPERIORITY_OR_OTHER|||||||0.02|||||||Chi-squared|||||||0.020
72416147|NCT04162769|144343102|SUPERIORITY||Response Rate Difference|15.2|STANDARD_ERROR_OF_MEAN|10.17|=|0.141|TWO_SIDED|95.0|-4.72|35.15|||Cochran-Mantel-Haenszel|||Week 12||35.15|-4.72|=0.1410
72416148|NCT04162769|144343103|SUPERIORITY||Response Rate Difference|8.4|STANDARD_ERROR_OF_MEAN|7.65|=|0.269|TWO_SIDED|95.0|-6.61|23.38|||Cochran-Mantel-Haenszel|||Week 12||23.38|-6.61|=0.2690
72416149|NCT04162769|144343103|SUPERIORITY||Response Rate Difference|4.3|STANDARD_ERROR_OF_MEAN|7.09|=|0.5428|TWO_SIDED|95.0|-9.56|18.25|||Cochran-Mantel-Haenszel|||Week 12||18.25|-9.56|=0.5428
72600815|NCT00856843|144730699|SUPERIORITY_OR_OTHER|||||||0.644|||||||Chi-squared|||||||0.644
72600816|NCT00856843|144730700|SUPERIORITY_OR_OTHER|||||||0.763|||||||Chi-squared|||||||0.763
72600817|NCT00856843|144730701|SUPERIORITY_OR_OTHER|||||||0.173|||||||Chi-squared|||||||0.173
72600818|NCT00856843|144730702|SUPERIORITY_OR_OTHER|||||||0.004|||||||Chi-squared|||||||0.004
72600819|NCT00856843|144730703|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Chi-squared|||||||<0.001
72600820|NCT00856843|144730704|SUPERIORITY_OR_OTHER|||||||0.005|||||||Chi-squared|||||||0.005
72600821|NCT00856843|144730705|SUPERIORITY_OR_OTHER|||||||0.013|||||||Chi-squared|||||||0.013
72600822|NCT00856843|144730706|SUPERIORITY_OR_OTHER|||||||0.283|||||||Chi-squared|||||||0.283
72600823|NCT03078127|144730710|SUPERIORITY|||||||0.615||||||ANOVA was performed (with multiple comparisons to compare each intervention to baseline) to assess for difference in MCC with each ACT. The a priori threshold for statistical significance was set to 0.05|ANOVA|||No comparable preliminary data exists on mucociliary clearance (MCC) in response to airway clearance therapy methods (ACTs) for a power calculation. However, prior studies of medication effect on MCC gave a baseline mean change of Ave270 clr of 27.7% (std dev of 15.1%). Thus, the investigators estimated a mean change of 20% for effective ACT with the same estimate for variability (Std Dev of 15.1%). Using a paired 2-tailed test to compare means, 7 subjects were estimated to be needed.||||0.615
72600824|NCT03078127|144730711|SUPERIORITY|||||||0.696||||||ANOVA was performed (with multiple comparisons to compare each intervention to baseline) to assess for difference in MCC with each ACT. The a priori threshold for significance was \< 0.05.|ANOVA|||||||0.696
72600825|NCT03078127|144730713|SUPERIORITY|||||||0.001||||||The a priori threshold of statistical significance was p = 0.05|t-test, 2 sided|||The investigators compared FENO before and after ACT in a pooled manner (i.e., grouping each of the comparisons together), as the study was not powered for FENO comparisons within each ACT type.||||0.001
72600826|NCT03078127|144730713|OTHER|A linear regression was performed between change in FENO and Ave90Clr||||||0.692||||||The a priori threshold for statistical significance (i.e., slope different than zero) between MCC and FENO was 0.05|Regression, Linear|||if the difference between pre and post-ACT FENO was significant (defined as p\<0.05), it was investigated whether change in FENO correlated with MCC (as represented by Ave90Clr)||||0.692
72600827|NCT03078127|144730714|SUPERIORITY|||||||0.146||||||Non-parametric test used due to lack of data normality. The a prior threshold for statistical significance was \< 0.05|Wilcoxon signed-rank test|||The study was not designed or powered to assess for inter-group differences between the types of ACT, and for analytical purposes, these were pooled, with the analysis being a paired comparison within subjects to pre- to post-ACT.||||0.146
72600828|NCT03078127|144730715|SUPERIORITY|||||||0.041||||||Non-parametric test used due to lack of data normality. The a priori threshold for statistical significance was \< 0.05|Wilcoxon signed-rank test|||The study was not designed or powered to assess for inter-group differences between the types of ACT, and for analytical purposes, these were pooled, with the analysis being a paired comparison within subjects to pre- to post-ACT.||||0.041
72600829|NCT03078127|144730715|OTHER|A linear regression was performed between change in pre and post-ACT adenosine (purine) in EBC and Ave90Clr||||||0.047||||||The a priori threshold of statistical significance was p = 0.05|Regression, Linear|||If the difference between pre and post-ACT adenosine (purine) in EBC was significant (defined as p\<0.05), the correlation between change in adenosine concentration and MCC (as represented by Ave90Clr) was investigated.||||0.047
72600830|NCT03078127|144730716|SUPERIORITY|||||||0.07||||||Non-parametric test used due to lack of data normality. The a priori threshold for statistical significance was \< 0.05|Wilcoxon signed-rank test|||The study was not designed or powered to assess for inter-group differences between the types of ACT, and for analytical purposes, these were pooled, with the analysis being a paired comparison within subjects to pre- to post-ACT.||||0.070
72416150|NCT04162769|144343104|SUPERIORITY||Least square mean difference|-2.81|STANDARD_ERROR_OF_MEAN|7.721|=|0.7163|TWO_SIDED|95.0|-18.089|12.466|||Mixed Models Analysis|||Week 12||12.466|-18.089|=0.7163
72600831|NCT01451554|144730717|SUPERIORITY_OR_OTHER|||||||0.06||95.0||||2 tailed t-test|t-test, 2 sided|||Data were compared between groups using the 2 sample T-test.||||0.06
72600832|NCT01451554|144730718|SUPERIORITY_OR_OTHER|||||||0.31||95.0|||||t-test, 2 sided|||Data were compared between groups using a 2 sample T-test.||||0.31
72600833|NCT01402986|144730719|SUPERIORITY_OR_OTHER||Rate Ratio|0.94||||0.709|TWO_SIDED|95.0|0.67|1.31|||Poisson regression|||The 95 percent (%) confidence interval (CI) for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 versus \[vs\] more than \[\>\] 2 but less than or equal to \[=\<\] 6), atopic asthma status (atopic/non-atopic), chronic oral corticosteroid (OCS) use (presence vs absence) and geographical region as the covariates.||1.31|0.67|0.709
72600834|NCT01402986|144730719|SUPERIORITY_OR_OTHER||Rate Ratio|1.02||||0.904|TWO_SIDED|95.0|0.71|1.46|||Poisson regression|||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \> 2 but =\< 6), atopic asthma status (atopic/non-atopic), chronic OCS use (presence vs absence) and geographical region as the covariates.||1.46|0.71|0.904
72600835|NCT01402986|144730736|SUPERIORITY_OR_OTHER||Rate Ratio|0.62||||0.293|TWO_SIDED|95.0|0.26|1.51|||Poisson regression|||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status (atopic/non-atopic), chronic OCS use (presence vs absence) and geographical region as the covariates.||1.51|0.26|0.293
72600836|NCT01402986|144730736|SUPERIORITY_OR_OTHER||Rate Ratio|0.62||||0.27|TWO_SIDED|95.0|0.27|1.44|||Poisson regression|||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status (atopic/non-atopic), chronic OCS use (presence vs absence) and geographical region as the covariates.||1.44|0.27|0.270
72600837|NCT01402986|144730737|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.81||||0.257|TWO_SIDED|95.0|0.57|1.16|||Regression, Cox|||||1.16|0.57|0.257
72600838|NCT01402986|144730737|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.8||||0.225|TWO_SIDED|95.0|0.56|1.15|||Regression, Cox|||||1.15|0.56|0.225
72416151|NCT04162769|144343104|SUPERIORITY||Least square mean difference|-13.24|STANDARD_ERROR_OF_MEAN|7.602|=|0.084|TWO_SIDED|95.0|-28.284|1.805|||Mixed Models Analysis|||Week 12||1.805|-28.284|=0.0840
72600839|NCT01402986|144730738|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.79||||0.538|TWO_SIDED|95.0|0.37|1.68|||Regression, Cox|||||1.68|0.37|0.538
72600840|NCT01402986|144730738|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.8||||0.561|TWO_SIDED|95.0|0.37|1.71|||Regression, Cox|||||1.71|0.37|0.561
72600841|NCT01402986|144730739|SUPERIORITY_OR_OTHER||Rate Ratio|0.73||||0.19|TWO_SIDED|95.0|0.46|1.17|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Baseline serum periostin \>= median||1.17|0.46|0.190
72600842|NCT01402986|144730739|SUPERIORITY_OR_OTHER||Rate Ratio|0.95||||0.856|TWO_SIDED|95.0|0.56|1.61|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Baseline serum periostin \>= median||1.61|0.56|0.856
72600843|NCT01402986|144730739|SUPERIORITY_OR_OTHER||Rate Ratio|1.13||||0.602|TWO_SIDED|95.0|0.71|1.81|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Baseline serum periostin \< median||1.81|0.71|0.602
72600844|NCT01402986|144730739|SUPERIORITY_OR_OTHER||Rate Ratio|0.91||||0.703|TWO_SIDED|95.0|0.55|1.5|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Baseline serum periostin \< median||1.50|0.55|0.703
72600845|NCT01402986|144730739|SUPERIORITY_OR_OTHER||Rate Ratio|0.86||||0.455|TWO_SIDED|95.0|0.58|1.28|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Baseline serum periostin \>= 25th Percentile||1.28|0.58|0.455
72600846|NCT01402986|144730739|SUPERIORITY_OR_OTHER||Rate Ratio|1.02||||0.929|TWO_SIDED|95.0|0.66|1.57|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Baseline serum periostin \>= 25th Percentile||1.57|0.66|0.929
72600847|NCT01402986|144730739|SUPERIORITY_OR_OTHER||Rate Ratio|1.26||||0.507|TWO_SIDED|95.0|0.63|2.51|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Baseline serum periostin \< 25th Percentile||2.51|0.63|0.507
72600848|NCT01402986|144730739|SUPERIORITY_OR_OTHER||Rate Ratio|0.91||||0.805|TWO_SIDED|95.0|0.44|1.89|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Baseline serum periostin \< 25th Percentile||1.89|0.44|0.805
72600849|NCT01402986|144730739|SUPERIORITY_OR_OTHER||Rate Ratio|0.88||||0.716|TWO_SIDED|95.0|0.44|1.75|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Baseline serum periostin \>= 75th Percentile||1.75|0.44|0.716
72600850|NCT01402986|144730739|SUPERIORITY_OR_OTHER||Rate Ratio|1.51||||0.328|TWO_SIDED|95.0|0.66|3.43|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Baseline serum periostin \>= 75th Percentile||3.43|0.66|0.328
72600851|NCT01402986|144730739|SUPERIORITY_OR_OTHER||Rate Ratio|0.95||||0.804|TWO_SIDED|95.0|0.64|1.41|||Poission regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Baseline serum periostin \< 75th Percentile||1.41|0.64|0.804
72600852|NCT01402986|144730739|SUPERIORITY_OR_OTHER||Rate Ratio|0.7||||0.088|TWO_SIDED|95.0|0.47|1.05|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Baseline serum periostin \< 75th Percentile||1.05|0.47|0.088
72600853|NCT01402986|144730740|SUPERIORITY_OR_OTHER||Rate Ratio|0.8||||0.365|TWO_SIDED|95.0|0.5|1.29|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Th2 high||1.29|0.50|0.365
72600854|NCT01402986|144730740|SUPERIORITY_OR_OTHER||Rate Ratio|0.97||||0.922|TWO_SIDED|95.0|0.56|1.68|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Th2 high||1.68|0.56|0.922
72600855|NCT01402986|144730740|SUPERIORITY_OR_OTHER||Rate Ratio|1.11||||0.685|TWO_SIDED|95.0|0.67|1.84|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Th2 Low||1.84|0.67|0.685
72600856|NCT01402986|144730740|SUPERIORITY_OR_OTHER||Rate Ratio|1.06||||0.813|TWO_SIDED|95.0|0.66|1.7|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Th2 Low||1.70|0.66|0.813
72600857|NCT01402986|144730741|SUPERIORITY_OR_OTHER||Rate Ratio|0.82||||0.335|TWO_SIDED|95.0|0.56|1.22|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Baseline eosinophil count \>=150 cells/mcgL||1.22|0.56|0.335
72600858|NCT01402986|144730741|SUPERIORITY_OR_OTHER||Rate Ratio|0.88||||0.586|TWO_SIDED|95.0|0.54|1.41|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Baseline eosinophil count \>=150 cells/mcgL||1.41|0.54|0.586
72600859|NCT01402986|144730741|SUPERIORITY_OR_OTHER||Rate Ratio|1.36||||0.331|TWO_SIDED|95.0|0.73|2.52|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Baseline eosinophil count \<150 cells/mcgL||2.52|0.73|0.331
72600860|NCT01402986|144730741|SUPERIORITY_OR_OTHER||Rate Ratio|1.41||||0.311|TWO_SIDED|95.0|0.73|2.71|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Baseline eosinophil count \<150 cells/mcgL||2.71|0.73|0.311
72416152|NCT02163733|144343131|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|90% CIs being within 70% to 143%.|Geometric mean ratio|106.05|||||TWO_SIDED|90.0|94.82|118.6|||||Fed / Fasted ratio. Linear mixed-effects model with sequence, period, and treatment as fixed effects and subject nested within sequence as a random effect. Least squares geometric mean ratio (LSGMR) Fed = 7847, Fasted = 7399.|Study sized so experiment-wise power for the 90% CIs of geometric mean ratios for both AUC and Cmax of AZD9291 being within 70-143% was 90% (95% for each parameter). Within patient CV assumed to be 34%. A 6% change in exposure was also assumed.||118.60|94.82|
72416153|NCT02163733|144343132|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|90% CIs being within 70% to 143%|Geometric mean ratio|92.75|||||TWO_SIDED|90.0|81.4|105.68|||||Fed / Fasted ratio. Linear mixed-effects model with sequence, period, and treatment as fixed effects and subject nested within sequence as a random effect. LSGMR Fed = 208.0, Fasted = 224.3.|Study sized so experiment-wise power for the 90% CIs of geometric mean ratios for both AUC and Cmax of AZD9291 being within 70-143% was 90% (95% for each parameter). Within patient CV assumed to be 34%. A 6% change in exposure was also assumed.||105.68|81.40|
72600861|NCT01402986|144730741|SUPERIORITY_OR_OTHER||Rate Ratio|0.81||||0.414|TWO_SIDED|95.0|0.48|1.35|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Baseline eosinophil count \>=300 cells/mcgL||1.35|0.48|0.414
72416154|NCT02163733|144343140|SUPERIORITY_OR_OTHER_LEGACY||Geometric mean ratio|81.15|||||TWO_SIDED|90.0|57.86|113.83|||||Fed / Fasted ratio. No pre-specified margins for equivalence test for metabolites, but analysed for consistency with AZD9291 analysis. Linear mixed-effects model with treatment as fixed effect. LSGMR Fed = 497.6, Fasted = 613.2.|AZ5104||113.83|57.86|
72416155|NCT02163733|144343140|SUPERIORITY_OR_OTHER_LEGACY||Geometric mean ratio|88.21|||||TWO_SIDED|90.0|65.21|119.32|||||Fed / Fasted ratio. No pre-specified margins for equivalence test for metabolites, but analysed for consistency with AZD9291 analysis. Linear mixed-effects model with treatment as fixed effect. LSGMR Fed = 235.0, Fasted = 266.4.|AZ7550||119.32|65.21|
72416156|NCT02163733|144343141|SUPERIORITY_OR_OTHER_LEGACY||Geometric mean ratio|76.68|||||TWO_SIDED|90.0|55.31|106.32|||||Fed / Fasted ratio. No pre-specified margins for equivalence test for metabolites, but analysed for consistency with AZD9291 analysis. Linear mixed-effects model with treatment as fixed effect. LSGMR Fed = 9.163, Fasted = 11.95.|AZ5104||106.32|55.31|
72600862|NCT01402986|144730741|SUPERIORITY_OR_OTHER||Rate Ratio|1.26||||0.463|TWO_SIDED|95.0|0.68|2.36|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Baseline eosinophil count \>=300 cells/mcgL||2.36|0.68|0.463
72600863|NCT01402986|144730741|SUPERIORITY_OR_OTHER||Rate Ratio|1.06||||0.793|TWO_SIDED|95.0|0.67|1.68|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Baseline eosinophil count \<300 cells/mcgL||1.68|0.67|0.793
72600864|NCT01402986|144730741|SUPERIORITY_OR_OTHER||Rate Ratio|0.77||||0.264|TWO_SIDED|95.0|0.49|1.22|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Baseline eosinophil count \<300 cells/mcgL||1.22|0.49|0.264
72600865|NCT01402986|144730742|SUPERIORITY_OR_OTHER||Rate Ratio|0.66||||0.245|TWO_SIDED|95.0|0.33|1.32|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Baseline FEV1 reversibility \>=12%||1.32|0.33|0.245
72600866|NCT01402986|144730742|SUPERIORITY_OR_OTHER||Rate Ratio|0.76||||0.438|TWO_SIDED|95.0|0.37|1.54|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Baseline FEV1 reversibility \>=12%||1.54|0.37|0.438
72600867|NCT01402986|144730742|SUPERIORITY_OR_OTHER||Rate Ratio|1.01||||0.947|TWO_SIDED|95.0|0.66|1.57|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Baseline FEV1 reversibility \<12%||1.57|0.66|0.947
72600868|NCT01402986|144730742|SUPERIORITY_OR_OTHER||Rate Ratio|0.97||||0.916|TWO_SIDED|95.0|0.59|1.59|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Baseline FEV1 reversibility \<12%||1.59|0.59|0.916
72600869|NCT01402986|144730743|SUPERIORITY_OR_OTHER||Rate Ratio|0.91||||0.723|TWO_SIDED|95.0|0.52|1.56|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Baseline FEV1% predicted \<=60%||1.56|0.52|0.723
72600870|NCT01402986|144730743|SUPERIORITY_OR_OTHER||Rate Ratio|1.06||||0.852|TWO_SIDED|95.0|0.6|1.86|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Baseline FEV1% predicted \<=60%||1.86|0.60|0.852
72600871|NCT01402986|144730743|SUPERIORITY_OR_OTHER||Rate Ratio|0.86||||0.409|TWO_SIDED|95.0|0.6|1.23|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Baseline FEV1% predicted \<=80%||1.23|0.60|0.409
72416157|NCT02163733|144343141|SUPERIORITY_OR_OTHER_LEGACY||Geometric mean ratio|82.92|||||TWO_SIDED|90.0|60.99|112.74|||||Fed / Fasted ratio. No pre-specified margins for equivalence test for metabolites, but analysed for consistency with AZD9291 analysis. Linear mixed-effects model with treatment as fixed effect. LSGMR Fed = 4.236, Fasted = 5.109.|AZ7550||112.74|60.99|
72600872|NCT01402986|144730743|SUPERIORITY_OR_OTHER||Rate Ratio|1.07||||0.744|TWO_SIDED|95.0|0.72|1.58|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Baseline FEV1% predicted \<=80%||1.58|0.72|0.744
72600873|NCT01402986|144730744|SUPERIORITY_OR_OTHER||Rate Ratio|0.94||||0.802|TWO_SIDED|95.0|0.58|1.52|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|2 asthma exacerbations in the past year||1.52|0.58|0.802
72600874|NCT01402986|144730744|SUPERIORITY_OR_OTHER||Rate Ratio|0.6||||0.05|TWO_SIDED|95.0|0.36|1.0|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|2 asthma exacerbations in the past year||1.00|0.36|0.050
72600875|NCT01402986|144730744|SUPERIORITY_OR_OTHER||Rate Ratio|0.93||||0.792|TWO_SIDED|95.0|0.56|1.56|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|\> 2 but \< 6 asthma exacerbations in the past year||1.56|0.56|0.792
72600876|NCT01402986|144730744|SUPERIORITY_OR_OTHER||Rate Ratio|1.39||||0.231|TWO_SIDED|95.0|0.81|2.38|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|\> 2 but \< 6 asthma exacerbations in the past year||2.38|0.81|0.231
72600877|NCT01402986|144730745|SUPERIORITY_OR_OTHER||Rate Ratio|0.25||||0.046|TWO_SIDED|95.0|0.06|0.98|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Baseline Serum Periostin \>=Median||0.98|0.06|0.046
72600878|NCT01402986|144730745|SUPERIORITY_OR_OTHER||Rate Ratio|0.47||||0.197|TWO_SIDED|95.0|0.15|1.48|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Baseline Serum Periostin \>=Median||1.48|0.15|0.197
72600879|NCT01402986|144730745|SUPERIORITY_OR_OTHER||Rate Ratio|1.18||||0.708|TWO_SIDED|95.0|0.5|2.79|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Baseline Serum Periostin \< Median||2.79|0.50|0.708
72600880|NCT01402986|144730745|SUPERIORITY_OR_OTHER||Rate Ratio|1.31||||0.594|TWO_SIDED|95.0|0.48|3.57|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Baseline Serum Periostin \< Median||3.57|0.48|0.594
72600881|NCT01402986|144730746|SUPERIORITY_OR_OTHER||Rate Ratio|1.03||||0.975|TWO_SIDED|95.0|0.14|7.67|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Baseline FEV1 reversibility \>=12%||7.67|0.14|0.975
72600882|NCT01402986|144730746|SUPERIORITY_OR_OTHER||Rate Ratio|1.66||||0.473|TWO_SIDED|95.0|0.41|6.67|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Baseline FEV1 reversibility \>=12%||6.67|0.41|0.473
72600883|NCT01402986|144730746|SUPERIORITY_OR_OTHER||Rate Ratio|0.49||||0.099|TWO_SIDED|95.0|0.21|1.14|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Baseline FEV1 reversibility \<12%||1.14|0.21|0.099
72416158|NCT02633800|144343164|OTHER|Both Log-rank test and Cox regression analysis did not adjust stratification factors.|Hazard Ratio (HR)|0.9291||||0.8342|TWO_SIDED|95.0|0.4856|1.7778||Unstratified Log-rank p-value|Log Rank|||Heregulin-high population - Patritumab vs Placebo||1.7778|0.4856|0.8342
72421622|NCT03720938|144354387|SUPERIORITY|||||||0.0534||||||The outcome of self-perception for strength competence was tested for any difference between groups by linear mixed-effects model analysis.|Linear mixed-effects model|Adjusted by Satterthwaite's degrees of freedom method for cluster effect, and small sample sizes in addition to baseline value and age.||Null hypothesis was the absence of difference between the two groups for the dependent variable self-perception of strength competence.||||0.0534
72600884|NCT01402986|144730746|SUPERIORITY_OR_OTHER||Rate Ratio|0.42||||0.148|TWO_SIDED|95.0|0.13|1.36|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Baseline FEV1 reversibility \<12%||1.36|0.13|0.148
72600885|NCT01402986|144730747|SUPERIORITY_OR_OTHER||Rate Ratio|0.82||||0.698|TWO_SIDED|95.0|0.31|2.19|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Th2 high||2.19|0.31|0.698
72600886|NCT01402986|144730747|SUPERIORITY_OR_OTHER||Rate Ratio|0.55||||0.299|TWO_SIDED|95.0|0.18|1.7|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Th2 high||1.70|0.18|0.299
72600887|NCT01402986|144730747|SUPERIORITY_OR_OTHER||Rate Ratio|0.25||||0.105|TWO_SIDED|95.0|0.05|1.34|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Th2 Low||1.34|0.05|0.105
72600888|NCT01402986|144730747|SUPERIORITY_OR_OTHER||Rate Ratio|0.7||||0.576|TWO_SIDED|95.0|0.2|2.47|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Th2 Low||2.47|0.20|0.576
72600889|NCT01402986|144730748|SUPERIORITY_OR_OTHER||Rate Ratio|0.48||||0.133|TWO_SIDED|95.0|0.19|1.25|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Baseline eosinophil count \>=300 cells/mcgL||1.25|0.19|0.133
72421623|NCT03720938|144354388|SUPERIORITY|||||||0.638505||||||The outcome of self-perception for body attractiveness was tested for any difference between groups by covariate analysis.|ANCOVA|Adjusted for self-perception for body attractiveness at baseline and confounding variable age.||Null hypothesis was the absence of difference between the two groups for the dependent variable self-perception of body attractiveness.||||0.638505
72600890|NCT01402986|144730748|SUPERIORITY_OR_OTHER||Rate Ratio|0.46||||0.241|TWO_SIDED|95.0|0.13|1.67|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Baseline eosinophil count \>=300 cells/mcgL||1.67|0.13|0.241
72600891|NCT01402986|144730748|SUPERIORITY_OR_OTHER||Rate Ratio|0.59||||0.51|TWO_SIDED|95.0|0.12|2.84|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Baseline eosinophil count \<300 cells/mcgL||2.84|0.12|0.510
72600892|NCT01402986|144730748|SUPERIORITY_OR_OTHER||Rate Ratio|0.74||||0.661|TWO_SIDED|95.0|0.19|2.85|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Baseline eosinophil count \<300 cells/mcgL||2.85|0.19|0.661
72600893|NCT01402986|144730749|SUPERIORITY_OR_OTHER||Difference of LS-mean|6.79||||0.057|TWO_SIDED|95.0|-0.21|13.79|||Repeated measure model|||Baseline serum periostin \>= median||13.79|-0.21|0.057
72600894|NCT01402986|144730749|SUPERIORITY_OR_OTHER||Difference of LS-mean|0.57||||0.874|TWO_SIDED|95.0|-6.54|7.68|||Repeated measure model|||Baseline serum periostin \>= median||7.68|-6.54|0.874
72600895|NCT01402986|144730749|SUPERIORITY_OR_OTHER||Difference of LS-mean|7.37||||0.028|TWO_SIDED|95.0|0.8|13.95|||Repeated measure model|||Baseline serum periostin \< median||13.95|0.80|0.028
72600896|NCT01402986|144730749|SUPERIORITY_OR_OTHER||Difference of LS-mean|1.09||||0.745|TWO_SIDED|95.0|-5.48|7.66|||Repeated measure model|||Baseline serum periostin \< median||7.66|-5.48|0.745
72600897|NCT01402986|144730749|SUPERIORITY_OR_OTHER||Difference of LS-mean|7.12||||0.011|TWO_SIDED|95.0|1.66|12.58|||Repeated measure model|||Baseline serum periostin \>= 25th percentile||12.58|1.66|0.011
72600898|NCT01402986|144730749|SUPERIORITY_OR_OTHER||Difference of LS-mean|-0.48||||0.863|TWO_SIDED|95.0|-5.93|4.97|||Repeated measure model|||Baseline serum periostin \>= 25th percentile||4.97|-5.93|0.863
72600899|NCT01402986|144730749|SUPERIORITY_OR_OTHER||Difference of LS-mean|6.24||||0.221|TWO_SIDED|95.0|-3.8|16.27|||Repeated measure model|||Baseline serum periostin \< 25th percentile||16.27|-3.80|0.221
72600900|NCT01402986|144730749|SUPERIORITY_OR_OTHER||Difference of LS-mean|8.58||||0.108|TWO_SIDED|95.0|-1.91|19.07|||Repeated measure model|||Baseline serum periostin \< 25th percentile||19.07|-1.91|0.108
72600901|NCT01402986|144730749|SUPERIORITY_OR_OTHER||Difference of LS-mean|9.89||||0.09|TWO_SIDED|95.0|-1.57|21.35|||Repeated measure model|||Baseline serum periostin \>= 75th percentile||21.35|-1.57|0.090
72600902|NCT01402986|144730749|SUPERIORITY_OR_OTHER||Difference of LS-mean|0.7||||0.908|TWO_SIDED|95.0|-11.19|12.59|||Repeated measure model|||Baseline serum periostin \>= 75th percentile||12.59|-11.19|0.908
72600903|NCT01402986|144730749|SUPERIORITY_OR_OTHER||Difference of LS-mean|6.52||||0.013|TWO_SIDED|95.0|1.41|11.64|||Repeated measure model|||Baseline serum periostin \< 75th percentile||11.64|1.41|0.013
72600904|NCT01402986|144730749|SUPERIORITY_OR_OTHER||Difference of LS-mean|1.23||||0.635|TWO_SIDED|95.0|-3.84|6.29|||Repeated measure model|||Baseline serum periostin \< 75th percentile||6.29|-3.84|0.635
72600905|NCT01402986|144730749|SUPERIORITY_OR_OTHER||Difference of LS-mean|8.89||||0.014|TWO_SIDED|95.0|1.84|15.94|||Repeated measure model|||Th2 high||15.94|1.84|0.014
72600906|NCT01402986|144730749|SUPERIORITY_OR_OTHER||Difference of LS-mean|3.91||||0.28|TWO_SIDED|95.0|-3.19|11.02|||Repeated measure model|||Th2 high||11.02|-3.19|0.280
72600907|NCT01402986|144730749|SUPERIORITY_OR_OTHER||Difference of LS-mean|3.22||||0.292|TWO_SIDED|95.0|-2.78|9.22|||Repeated measure model|||Th2 low||9.22|-2.78|0.292
72600908|NCT01402986|144730749|SUPERIORITY_OR_OTHER||Difference of LS-mean|-1.18||||0.691|TWO_SIDED|95.0|-6.99|4.64|||Repeated measure model|||Th2 low||4.64|-6.99|0.691
72600909|NCT01402986|144730749|SUPERIORITY_OR_OTHER||Difference of LS-mean|8.83||||0.004|TWO_SIDED|95.0|2.85|14.81|||Repeated measure model|||Baseline peripheral blood eosinophil count \>= 150 cells/μL||14.81|2.85|0.004
72600910|NCT01402986|144730749|SUPERIORITY_OR_OTHER||Difference of LS-mean|4.25||||0.177|TWO_SIDED|95.0|-1.92|10.43|||Repeated measure model|||Baseline peripheral blood eosinophil count \>= 150 cells/μL||10.43|-1.92|0.177
72600911|NCT01402986|144730749|SUPERIORITY_OR_OTHER||Difference of LS-mean|6.05||||0.159|TWO_SIDED|95.0|-2.39|14.5|||Repeated measure model|||Baseline peripheral blood eosinophil count \< 150 cells/μL||14.50|-2.39|0.159
72600912|NCT01402986|144730749|SUPERIORITY_OR_OTHER||Difference of LS-mean|-0.72||||0.857|TWO_SIDED|95.0|-8.63|7.18|||Repeated measure model|||Baseline peripheral blood eosinophil count \< 150 cells/μL||7.18|-8.63|0.857
72600913|NCT01402986|144730749|SUPERIORITY_OR_OTHER||Difference of LS-mean|13.75||||0.002|TWO_SIDED|95.0|5.28|22.22|||Repeated measure model|||Baseline peripheral blood eosinophil count \>= 300 cells/μL||22.22|5.28|0.002
72416159|NCT00464815|144343177|NON_INFERIORITY|Criterion for non-inferiority: the lower limit (LL) of the 2-sided standardized asymptotic 95% confidence interval (CI) for the group difference (Nimenrix Group minus Mencevax ACWY Group) in the percentage of subjects with bactericidal vaccine response was greater than or equal to (≥) the pre-defined clinical limit of -10%.|Rate difference|7.87|||||TWO_SIDED|95.0|1.63|14.87||||||To demonstrate the non-inferiority of Nimenrix vaccine versus Mencevax ACWY vaccine in term of rSBA-MenA vaccine response, the standardized asymptotic 95% CI for the difference in rSBA vaccine response rate for the meningococcal serogroup A (Nimenrix Group rate minus Mencevax ACWY Group rate) one month after vaccination was computed.||14.87|1.63|
72421624|NCT03720938|144354388|SUPERIORITY|||||||0.632||||||Linear mixed-effects model fit by maximum likelihood since restricted maximum likelihood assumes a strong normality.|Linear mixed effects model|Adjusted for cluster effect in addition to baseline value and age.||Null hypothesis was the absence of difference between the two groups for the dependent variable self-perception of body attractiveness.||||0.632
72600914|NCT01402986|144730749|SUPERIORITY_OR_OTHER||Difference of LS-mean|5.23||||0.243|TWO_SIDED|95.0|-3.56|14.02|||Repeated measure model|||Baseline peripheral blood eosinophil count \>= 300 cells/μL||14.02|-3.56|0.243
72600915|NCT01402986|144730749|SUPERIORITY_OR_OTHER||Difference of LS-mean|4.37||||0.144|TWO_SIDED|95.0|-1.5|10.24|||Repeated measure model|||Baseline peripheral blood eosinophil count \< 300 cells/μL||10.24|-1.50|0.144
72600916|NCT01402986|144730749|SUPERIORITY_OR_OTHER||Difference of LS-mean|0.72||||0.804|TWO_SIDED|95.0|-5.01|6.46|||Baseline peripheral blood eosinophil cou|||Baseline peripheral blood eosinophil count \< 300 cells/μ||6.46|-5.01|0.804
72600917|NCT01402986|144730749|SUPERIORITY_OR_OTHER||Difference of LS-mean|11.19||||0.029|TWO_SIDED|95.0|1.15|21.23|||Repeated measure model|||Baseline FEV1 reversibility \>= 12%||21.23|1.15|0.029
72600918|NCT01402986|144730749|SUPERIORITY_OR_OTHER||Difference of LS-mean|0.72||||0.887|TWO_SIDED|95.0|-9.19|10.62|||Repeated measure model|||Baseline FEV1 reversibility \>= 12%||10.62|-9.19|0.887
72600919|NCT01402986|144730749|SUPERIORITY_OR_OTHER||Difference of LS-mean|7.67||||0.002|TWO_SIDED|95.0|2.76|12.59|||Repeated measure model|||Baseline FEV1 reversibility \< 12%||12.59|2.76|0.002
72600920|NCT01402986|144730749|SUPERIORITY_OR_OTHER||Difference of LS-mean|2.79||||0.268|TWO_SIDED|95.0|-2.15|7.74|||Repeated measure model|||Baseline FEV1 reversibility \< 12%||7.74|-2.15|0.268
72600921|NCT01402986|144730749|SUPERIORITY_OR_OTHER||Difference of LS-mean|7.82||||0.003|TWO_SIDED|95.0|2.64|13.01|||Repeated measure model|||2 asthma exacerbations in the past year||13.01|2.64|0.003
72600922|NCT01402986|144730749|SUPERIORITY_OR_OTHER||Difference of LS-mean|2.42||||0.361|TWO_SIDED|95.0|-2.78|7.62|||Repeated measure model|||2 asthma exacerbations in the past year||7.62|-2.78|0.361
72600923|NCT01402986|144730749|SUPERIORITY_OR_OTHER||Difference of LS-mean|6.34||||0.185|TWO_SIDED|95.0|-3.06|15.75|||Repeated measure model|||\> 2 but \< 6 asthma exacerbations in the past year||15.75|-3.06|0.185
72600924|NCT01402986|144730749|SUPERIORITY_OR_OTHER||Difference of LS-mean|-0.08||||0.986|TWO_SIDED|95.0|-9.5|9.34|||Repeated measure model|||\> 2 but \< 6 asthma exacerbations in the past year||9.34|-9.50|0.986
72600925|NCT01402986|144730749|SUPERIORITY_OR_OTHER||Difference of LS-mean|0.87||||0.912|TWO_SIDED|95.0|-14.7|16.44|||Repeated measure model|||Chronic OCS use||16.44|-14.70|0.912
72600926|NCT01402986|144730749|SUPERIORITY_OR_OTHER||Difference of LS-mean|-1.46||||0.86|TWO_SIDED|95.0|-17.76|14.84|||Repeated measure model|||Chronic OCS use||14.84|-17.76|0.860
72600927|NCT01402986|144730749|SUPERIORITY_OR_OTHER||Difference of LS-mean|7.56||||0.002|TWO_SIDED|95.0|2.76|12.36|||Repeated measure model|||Without chronic OCS use||12.36|2.76|0.002
72600928|NCT01402986|144730749|SUPERIORITY_OR_OTHER||Difference of LS-mean|1.28||||0.601|TWO_SIDED|95.0|-3.51|6.06|||Repeated measure model|||Without chronic OCS use||6.06|-3.51|0.601
72600929|NCT01402986|144730750|SUPERIORITY_OR_OTHER||Difference of LS-mean|-0.24||||0.145|TWO_SIDED|95.0|-0.57|0.08|||Repeated measure model|||Baseline serum periostin \>= median||0.08|-0.57|0.145
72600930|NCT01402986|144730750|SUPERIORITY_OR_OTHER||Difference of LS-mean|0.05||||0.759|TWO_SIDED|95.0|-0.28|0.38|||Repeated measure model|||Baseline serum periostin \>= median||0.38|-0.28|0.759
72600931|NCT01402986|144730750|SUPERIORITY_OR_OTHER||Difference of LS-mean|-0.01||||0.936|TWO_SIDED|95.0|-0.38|0.35|||Repeated measure model|||Baseline serum periostin \< median||0.35|-0.38|0.936
72600932|NCT01402986|144730750|SUPERIORITY_OR_OTHER||Difference of LS-mean|-0.28||||0.127|TWO_SIDED|95.0|-0.64|0.08|||Repeated measure model|||Baseline serum periostin \< median||0.08|-0.64|0.127
72600933|NCT01402986|144730750|SUPERIORITY_OR_OTHER||Difference of LS-mean|-0.13||||0.343|TWO_SIDED|95.0|-0.41|0.14|||Repeated measure model|||Baseline serum periostin\>= 25th percentile||0.14|-0.41|0.343
72600934|NCT01402986|144730750|SUPERIORITY_OR_OTHER||Difference of LS-mean|-0.01||||0.928|TWO_SIDED|95.0|-0.29|0.27|||Repeated measure model|||Baseline serum periostin\>= 25th percentile||0.27|-0.29|0.928
72600935|NCT01402986|144730750|SUPERIORITY_OR_OTHER||Difference of LS-mean|-0.23||||0.374|TWO_SIDED|95.0|-0.74|0.28|||Repeated measure model|||Baseline serum periostin \< 25th percentile||0.28|-0.74|0.374
72600936|NCT01402986|144730750|SUPERIORITY_OR_OTHER||Difference of LS-mean|-0.29||||0.259|TWO_SIDED|95.0|-0.81|0.22|||Repeated measure model|||Baseline serum periostin \< 25th percentile||0.22|-0.81|0.259
72600937|NCT01402986|144730750|SUPERIORITY_OR_OTHER||Difference of LS-mean|-0.37||||0.127|TWO_SIDED|95.0|-0.84|0.11|||Repeated measure model|||Baseline serum periostin \>= 75th percentile||0.11|-0.84|0.127
72600938|NCT01402986|144730750|SUPERIORITY_OR_OTHER||Difference of LS-mean|-0.07||||0.775|TWO_SIDED|95.0|-0.56|0.42|||Repeated measure model|||Baseline serum periostin \>= 75th percentile||0.42|-0.56|0.775
72600939|NCT01402986|144730750|SUPERIORITY_OR_OTHER||Difference of LS-mean|-0.1||||0.512|TWO_SIDED|95.0|-0.38|0.19|||Repeated measure model|||Baseline serum periostin \< 75th percentile||0.19|-0.38|0.512
72600940|NCT01402986|144730750|SUPERIORITY_OR_OTHER||Difference of LS-mean|-0.12||||0.404|TWO_SIDED|95.0|-0.4|0.16|||Repeated measure model|||Baseline serum periostin \< 75th percentile||0.16|-0.40|0.404
72600941|NCT01402986|144730750|SUPERIORITY_OR_OTHER||Difference of LS-mean|-0.24||||0.181|TWO_SIDED|95.0|-0.59|0.11|||Repeated measure model|||Th2 high||0.11|-0.59|0.181
72600942|NCT01402986|144730750|SUPERIORITY_OR_OTHER||Difference of LS-mean|-0.25||||0.161|TWO_SIDED|95.0|-0.6|0.1|||Repeated measure model|||Th2 high||0.10|-0.60|0.161
72600943|NCT01402986|144730750|SUPERIORITY_OR_OTHER||Difference of LS-mean|-0.11||||0.54|TWO_SIDED|95.0|-0.47|0.25|||Repeated measure model|||Th2 low||0.25|-0.47|0.540
72600944|NCT01402986|144730750|SUPERIORITY_OR_OTHER||Difference of LS-mean|-0.07||||0.674|TWO_SIDED|95.0|-0.42|0.27|||Repeated measure model|||Th2 low||0.27|-0.42|0.674
72600945|NCT01402986|144730750|SUPERIORITY_OR_OTHER||Difference of LS-mean|-0.22||||0.154|TWO_SIDED|95.0|-0.52|0.08|||Repeated measure model|||Baseline peripheral blood eosinophil count \>= 150 cells/μL||0.08|-0.52|0.154
72600946|NCT01402986|144730750|SUPERIORITY_OR_OTHER||Difference of LS-mean|-0.17||||0.271|TWO_SIDED|95.0|-0.48|0.13|||Repeated measure model|||Baseline peripheral blood eosinophil count \>= 150 cells/μ||0.13|-0.48|0.271
72600947|NCT01402986|144730750|SUPERIORITY_OR_OTHER||Difference of LS-mean|-0.08||||0.725|TWO_SIDED|95.0|-0.51|0.36|||Repeated measure model|||Baseline peripheral blood eosinophil count \< 150 cells/μL||0.36|-0.51|0.725
72600948|NCT01402986|144730750|SUPERIORITY_OR_OTHER||Difference of LS-mean|-0.12||||0.559|TWO_SIDED|95.0|-0.53|0.28|||Repeated measure model|||Baseline peripheral blood eosinophil count \< 150 cells/μL||0.28|-0.53|0.559
72600949|NCT01402986|144730750|SUPERIORITY_OR_OTHER||Difference of LS-mean|-0.47||||0.019|TWO_SIDED|95.0|-0.87|-0.08|||Repeated measure model|||Baseline peripheral blood eosinophil count \>= 300 cells/μL||-0.08|-0.87|0.019
72600950|NCT01402986|144730750|SUPERIORITY_OR_OTHER||Difference of LS-mean|-0.2||||0.348|TWO_SIDED|95.0|-0.61|0.21|||Repeated measure model|||Baseline peripheral blood eosinophil count \>= 300 cells/μL||0.21|-0.61|0.348
72600951|NCT01402986|144730750|SUPERIORITY_OR_OTHER||Difference of LS-mean|-0.03||||0.855|TWO_SIDED|95.0|-0.35|0.29|||Repeated measure model|||Baseline peripheral blood eosinophil count \< 300 cells/μL||0.29|-0.35|0.855
72600952|NCT01402986|144730750|SUPERIORITY_OR_OTHER||Difference of LS-mean|-0.2||||0.203|TWO_SIDED|95.0|-0.5|0.11|||Repeated measure model|||Baseline peripheral blood eosinophil count \< 300 cells/μL||0.11|-0.50|0.203
72600953|NCT01402986|144730750|SUPERIORITY_OR_OTHER||Difference of LS-mean|-0.44||||0.055|TWO_SIDED|95.0|-0.89|0.01|||Repeated measure model|||Baseline FEV1 reversibility \>= 12%||0.01|-0.89|0.055
72600954|NCT01402986|144730750|SUPERIORITY_OR_OTHER||Difference of LS-mean|-0.37||||0.104|TWO_SIDED|95.0|-0.82|0.08|||Repeated measure model|||Baseline FEV1 reversibility \>= 12%||0.08|-0.82|0.104
72600955|NCT01402986|144730750|SUPERIORITY_OR_OTHER||Difference of LS-mean|-0.07||||0.652|TWO_SIDED|95.0|-0.37|0.23|||Repeated measure model|||Baseline FEV1 reversibility \< 12%||0.23|-0.37|0.652
72600956|NCT01402986|144730750|SUPERIORITY_OR_OTHER||Difference of LS-mean|0.02||||0.905|TWO_SIDED|95.0|-0.28|0.32|||Repeated measure model|||Baseline FEV1 reversibility \< 12%||0.32|-0.28|0.905
72600957|NCT01402986|144730750|SUPERIORITY_OR_OTHER||Difference of LS-mean|-0.19||||0.198|TWO_SIDED|95.0|-0.49|0.1|||Repeated measure model|||2 asthma exacerbations in the past year||0.10|-0.49|0.198
72600958|NCT01402986|144730750|SUPERIORITY_OR_OTHER||Difference of LS-mean|-0.18||||0.226|TWO_SIDED|95.0|-0.47|0.11|||Repeated measure model|||2 asthma exacerbations in the past year||0.11|-0.47|0.226
72600959|NCT01402986|144730750|SUPERIORITY_OR_OTHER||Difference of LS-mean|-0.14||||0.513|TWO_SIDED|95.0|-0.56|0.28|||Repeated measure model|||\> 2 but \< 6 asthma exacerbations in the past year||0.28|-0.56|0.513
72600960|NCT01402986|144730750|SUPERIORITY_OR_OTHER||Difference of LS-mean|-0.01||||0.974|TWO_SIDED|95.0|-0.43|0.42|||Repeated measure model|||\> 2 but \< 6 asthma exacerbations in the past year||0.42|-0.43|0.974
72600961|NCT01402986|144730750|SUPERIORITY_OR_OTHER||Difference of LS-mean|-0.37||||0.226|TWO_SIDED|95.0|-0.97|0.23|||Repeated measure model|||Chronic OCS use||0.23|-0.97|0.226
72600962|NCT01402986|144730750|SUPERIORITY_OR_OTHER||Difference of LS-mean|0.15||||0.613|TWO_SIDED|95.0|-0.44|0.75|||Repeated measure model|||Chronic OCS use||0.75|-0.44|0.613
72600963|NCT01402986|144730750|SUPERIORITY_OR_OTHER||Difference of LS-mean|-0.17||||0.198|TWO_SIDED|95.0|-0.43|0.09|||Repeated measure model|||Without chronic OCS use||0.09|-0.43|0.198
72600964|NCT01402986|144730750|SUPERIORITY_OR_OTHER||Difference of LS-mean|-0.19||||0.165|TWO_SIDED|95.0|-0.45|0.08|||Repeated measure model|||Without chronic OCS use||0.08|-0.45|0.165
72600965|NCT01402986|144730751|SUPERIORITY_OR_OTHER||Difference of LS-mean|0.23||||0.211|TWO_SIDED|95.0|-0.13|0.6|||Repeated measure model|||Baseline serum periostin \>= median||0.60|-0.13|0.211
72600966|NCT01402986|144730751|SUPERIORITY_OR_OTHER||Difference of LS-mean|0.16||||0.397|TWO_SIDED|95.0|-0.21|0.53|||Repeated measure model|||Baseline serum periostin \>= median||0.53|-0.21|0.397
72600967|NCT01402986|144730751|SUPERIORITY_OR_OTHER||Difference of LS-mean|0.19||||0.315|TWO_SIDED|95.0|-0.18|0.56|||Repeated Measure Model|||Baseline serum periostin \< median||0.56|-0.18|0.315
72600968|NCT01402986|144730751|SUPERIORITY_OR_OTHER||Difference of LS-mean|0.26||||0.166|TWO_SIDED|95.0|-0.11|0.63|||Repeated measure model|||Baseline serum periostin \< median||0.63|-0.11|0.166
72600969|NCT01402986|144730751|SUPERIORITY_OR_OTHER||Difference of LS-mean|0.17||||0.262||95.0|-0.13|0.47|||Repeated measure model|||Baseline serum periostin \>= 25th percentile||0.47|-0.13|0.262
72600970|NCT01402986|144730751|SUPERIORITY_OR_OTHER||Difference of LS-mean|0.14||||0.379|TWO_SIDED|95.0|-0.17|0.44|||Repeated measure model|||Baseline serum periostin \>= 25th percentile||0.44|-0.17|0.379
72600971|NCT01402986|144730751|SUPERIORITY_OR_OTHER||Difference of LS-mean|0.25||||0.387|TWO_SIDED|95.0|-0.32|0.81|||Repeated measure model|||Baseline serum periostin \< 25th percentile||0.81|-0.32|0.387
72600972|NCT01402986|144730751|SUPERIORITY_OR_OTHER||Difference of LS-mean|0.29||||0.303|TWO_SIDED|95.0|-0.26|0.84|||Repeated measure model|||Baseline serum periostin \< 25th percentile||0.84|-0.26|0.303
72600973|NCT01402986|144730751|SUPERIORITY_OR_OTHER||Difference of LS-mean|-0.37||||0.127|TWO_SIDED|95.0|-0.84|0.11|||Repeated measure model|||Baseline serum periostin \>=75th percentile||0.11|-0.84|0.127
72600974|NCT01402986|144730751|SUPERIORITY_OR_OTHER||Difference of LS-mean|-0.07||||0.775|TWO_SIDED|95.0|-0.56|0.42|||Repeated measure model|||Baseline serum periostin \>=75th percentile||0.42|-0.56|0.775
72600975|NCT01402986|144730751|SUPERIORITY_OR_OTHER||Difference of LS-mean|-0.1||||0.512|TWO_SIDED|95.0|-0.38|0.19|||Repeated measure model|||Baseline serum periostin \< 75th percentile||0.19|-0.38|0.512
72600976|NCT01402986|144730751|SUPERIORITY_OR_OTHER||Difference of LS-mean|-0.12||||0.404|TWO_SIDED|95.0|-0.4|0.16|||Repeated measure model|||Baseline serum periostin \< 75th percentile||0.16|-0.40|0.404
72600977|NCT01402986|144730751|SUPERIORITY_OR_OTHER||Difference of LS-mean|0.31||||0.102|TWO_SIDED|95.0|-0.06|0.69|||Repeated measure model|||Th2 high||0.69|-0.06|0.102
72600978|NCT01402986|144730751|SUPERIORITY_OR_OTHER||Difference of LS-mean|0.3||||0.116|TWO_SIDED|95.0|-0.08|0.68|||Repeated measure model|||Th2 high||0.68|-0.08|0.116
72600979|NCT01402986|144730751|SUPERIORITY_OR_OTHER||Difference of LS-mean|-0.11||||0.54|TWO_SIDED|95.0|-0.47|0.25|||Repeated measure model|||Th2 low||0.25|-0.47|0.540
72600980|NCT01402986|144730751|SUPERIORITY_OR_OTHER||Difference of LS-mean|-0.07||||0.674|TWO_SIDED|95.0|-0.42|0.27|||Repeated measure model|||Th2 low||0.27|-0.42|0.674
72600981|NCT01402986|144730751|SUPERIORITY_OR_OTHER||Difference of LS-mean|0.17||||0.295|TWO_SIDED|95.0|-0.15|0.49|||Repeated measure model|||Baseline peripheral blood eosinophil count \>=150 cells/μL||0.49|-0.15|0.295
72600982|NCT01402986|144730751|SUPERIORITY_OR_OTHER||Difference of LS-mean|0.16||||0.342|TWO_SIDED|95.0|-0.17|0.49|||Repeated measure model|||Baseline peripheral blood eosinophil count \>=150 cells/μL||0.49|-0.17|0.342
72600983|NCT01402986|144730751|SUPERIORITY_OR_OTHER||Difference of LS-mean|0.18||||0.406|TWO_SIDED|95.0|-0.24|0.6|||Repeated measure model|||Baseline peripheral blood eosinophil count \< 150 cells/μL||0.60|-0.24|0.406
72600984|NCT01402986|144730751|SUPERIORITY_OR_OTHER||Difference of LS-mean|0.38||||0.069|TWO_SIDED|95.0|-0.03|0.79|||Repeated measure model|||Baseline peripheral blood eosinophil count \< 150 cells/μL||0.79|-0.03|0.069
72600985|NCT01402986|144730751|SUPERIORITY_OR_OTHER||Difference of LS-mean|0.19||||0.371|TWO_SIDED|95.0|-0.23|0.62|||Repeated measure model|||Baseline peripheral blood eosinophil count \>= 300 cells/μL||0.62|-0.23|0.371
72600986|NCT01402986|144730751|SUPERIORITY_OR_OTHER||Difference of LS-mean|0.07||||0.766|TWO_SIDED|95.0|-0.37|0.51|||Repeated measure model|||Baseline peripheral blood eosinophil count \>= 300 cells/μL||0.51|-0.37|0.766
72600987|NCT01402986|144730751|SUPERIORITY_OR_OTHER||Difference of LS-mean|0.24||||0.147|TWO_SIDED|95.0|-0.09|0.57|||Repeated measure model|||Baseline peripheral blood eosinophil count \< 300 cells/μL||0.57|-0.09|0.147
72600988|NCT01402986|144730751|SUPERIORITY_OR_OTHER||Difference of LS-mean|0.35||||0.031|TWO_SIDED|95.0|0.03|0.68|||Repeated measure model|||Baseline peripheral blood eosinophil count \< 300 cells/μL||0.68|0.03|0.031
72600989|NCT01402986|144730751|SUPERIORITY_OR_OTHER||Difference of LS-mean|0.59||||0.02|TWO_SIDED|95.0|0.1|1.09|||Repeated measure model|||Baseline FEV1 reversibility \>= 12%||1.09|0.10|0.020
72600990|NCT01402986|144730751|SUPERIORITY_OR_OTHER||Difference of LS-mean|0.29||||0.226|TWO_SIDED|95.0|-0.18|0.77|||Repeated measure model|||Baseline FEV1 reversibility \>= 12%||0.77|-0.18|0.226
72600991|NCT01402986|144730751|SUPERIORITY_OR_OTHER||Difference of LS-mean|0.01||||0.964|TWO_SIDED|95.0|-0.31|0.33|||Repeated measure model|||Baseline FEV1 reversibility \< 12%||0.33|-0.31|0.964
72600992|NCT01402986|144730751|SUPERIORITY_OR_OTHER||Difference of LS-mean|0.1||||0.533|TWO_SIDED|95.0|-0.22|0.42|||Repeated measure model|||Baseline FEV1 reversibility \< 12%||0.42|-0.22|0.533
72600993|NCT01402986|144730751|SUPERIORITY_OR_OTHER||Difference of LS-mean|0.17||||0.292|TWO_SIDED|95.0|-0.15|0.5|||Repeated measure model|||2 asthma exacerbations in the past year||0.50|-0.15|0.292
72600994|NCT01402986|144730751|SUPERIORITY_OR_OTHER||Difference of LS-mean|0.27||||0.097|TWO_SIDED|95.0|-0.05|0.59|||Repeated measure model|||2 asthma exacerbations in the past year||0.59|-0.05|0.097
72600995|NCT01402986|144730751|SUPERIORITY_OR_OTHER||Difference of LS-mean|0.24||||0.26|TWO_SIDED|95.0|-0.18|0.67|||Repeated measure model|||\> 2 but \< 6 asthma exacerbations in the past year||0.67|-0.18|0.260
72600996|NCT01402986|144730751|SUPERIORITY_OR_OTHER||Difference of LS-mean|0.1||||0.648|TWO_SIDED|95.0|-0.33|0.53|||Repeated measure model|||\> 2 but \< 6 asthma exacerbations in the past year||0.53|-0.33|0.648
72600997|NCT01402986|144730751|SUPERIORITY_OR_OTHER||Difference of LS-mean|0.28||||0.398|TWO_SIDED|95.0|-0.37|0.93|||Repeated measure model|||Chronic OCS use||0.93|-0.37|0.398
72600998|NCT01402986|144730751|SUPERIORITY_OR_OTHER||Difference of LS-mean|-0.32||||0.327|TWO_SIDED|95.0|-0.95|0.32|||Repeated measure model|||Chronic OCS use||0.32|-0.95|0.327
72600999|NCT01402986|144730751|SUPERIORITY_OR_OTHER||Difference of LS-mean|0.23||||0.105|TWO_SIDED|95.0|-0.05|0.52|||Repeated measure model|||Without chronic OCS use||0.52|-0.05|0.105
72601000|NCT01402986|144730751|SUPERIORITY_OR_OTHER||Difference of LS-mean|0.31||||0.03|TWO_SIDED|95.0|0.03|0.6|||Repeated measure model|||Without chronic OCS use||0.60|0.03|0.030
72601001|NCT01402986|144730752|SUPERIORITY_OR_OTHER||Rate Ratio|0.95||||0.803|TWO_SIDED|95.0|0.62|1.44|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Atopic asthma||1.44|0.62|0.803
72416160|NCT00464815|144343177|NON_INFERIORITY|Criterion for non-inferiority: the lower limit (LL) of the 2-sided standardized asymptotic 95% confidence interval for the group difference \[Nimenrix Group minus Mencevax ACWY Group\] in the percentage of subjects with bactericidal vaccine response was greater than or equal to (≥) the pre-defined clinical limit of -10%.|Rate Difference|0.67|||||TWO_SIDED|95.0|-1.65|4.18||||||To demonstrate the non-inferiority of Nimenrix vaccine versus Mencevax ACWY vaccine in term of rSBA-MenC vaccine response, the standardized asymptotic 95% CI for the difference in rSBA vaccine response rate for the meningococcal serogroup C (Nimenrix Group rate minus Mencevax ACWY Group rate) one month after vaccination was computed.||4.18|-1.65|
72601002|NCT01402986|144730752|SUPERIORITY_OR_OTHER||Rate Ratio|0.83||||0.457|TWO_SIDED|95.0|0.52|1.35|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Atopic asthma||1.35|0.52|0.457
72601003|NCT01402986|144730752|SUPERIORITY_OR_OTHER||Rate Ratio|0.71||||0.25|TWO_SIDED|95.0|0.4|1.27|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Non-atopic asthma||1.27|0.40|0.250
72601004|NCT01402986|144730752|SUPERIORITY_OR_OTHER||Rate Ratio|1.07||||0.794|TWO_SIDED|95.0|0.66|1.74|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Non-atopic asthma||1.74|0.66|0.794
72601005|NCT01402986|144730753|SUPERIORITY_OR_OTHER||Rate Ratio|1.2||||0.614|TWO_SIDED|95.0|0.59|2.46|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|With chronic OCS use||2.46|0.59|0.614
72601006|NCT01402986|144730753|SUPERIORITY_OR_OTHER||Rate Ratio|1.29||||0.506|TWO_SIDED|95.0|0.61|2.74|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|With chronic OCS use||2.74|0.61|0.506
72601007|NCT01402986|144730753|SUPERIORITY_OR_OTHER||Rate Ratio|0.79||||0.243||95.0|0.53|1.18|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Without chronic OCS use||1.18|0.53|0.243
72601008|NCT01402986|144730753|SUPERIORITY_OR_OTHER||Rate Ratio|0.87||||0.531|TWO_SIDED|95.0|0.57|1.34|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Without chronic OCS use||1.34|0.57|0.531
72601009|NCT02634983|144730774|NON_INFERIORITY|Parameters were analyzed using mixed effects model including sequence, period, treatment as fixed factors and patient as random factor.|Mean Difference (Final Values)|5.0|STANDARD_ERROR_OF_MEAN|2.11||0.0254|TWO_SIDED|90.0|1.4|8.6|||t-test, 2 sided|||Global Ventilated Lung Volume||8.60|1.40|0.0254
72601010|NCT02634983|144730775|NON_INFERIORITY|Parameters were analyzed using mixed effects model including sequence, period, treatment as fixed factors and patient as random factor.|Mean Difference (Final Values)|4.77|STANDARD_ERROR_OF_MEAN|2.15||0.035|TWO_SIDED|90.0|1.11|8.44|||t-test, 2 sided|||Lung, Left Ventilation||8.44|1.11|0.0350
72601011|NCT02634983|144730775|NON_INFERIORITY|Parameters were analyzed using mixed effects model including sequence, period, treatment as fixed factors and patient as random factor.|Mean Difference (Final Values)|4.96|STANDARD_ERROR_OF_MEAN|2.86||0.0946|TWO_SIDED|90.0|0.08|9.84|||t-test, 2 sided|||Lung, Left Lower Lobe Ventilation||9.84|0.08|0.0946
72601012|NCT02634983|144730775|NON_INFERIORITY|Parameters were analyzed using mixed effects model including sequence, period, treatment as fixed factors and patient as random factor.|Mean Difference (Final Values)|4.97|STANDARD_ERROR_OF_MEAN|2.41||0.0486|TWO_SIDED|90.0|0.87|9.07|||t-test, 2 sided|||Lung, Left Upper Lobe Ventilation||9.07|0.87|0.0486
72601013|NCT02634983|144730775|NON_INFERIORITY|Parameters were analyzed using mixed effects model including sequence, period, treatment as fixed factors and patient as random factor.|Mean Difference (Final Values)|5.39|STANDARD_ERROR_OF_MEAN|2.33||0.0286|TWO_SIDED|90.0|1.42|9.35|||t-test, 2 sided|||Lung, Right Ventilation||9.35|1.42|0.0286
72601014|NCT02634983|144730775|NON_INFERIORITY|Parameters were analyzed using mixed effects model including sequence, period, treatment as fixed factors and patient as random factor.|Mean Difference (Final Values)|3.27|STANDARD_ERROR_OF_MEAN|2.29||0.165|TWO_SIDED|90.0|-0.63|7.17|||t-test, 2 sided|||Lung, Right Lower Lobe Ventilation||7.17|-0.63|0.1650
72601015|NCT02634983|144730775|NON_INFERIORITY|Parameters were analyzed using mixed effects model including sequence, period, treatment as fixed factors and patient as random factor.|Mean Difference (Final Values)|5.61|STANDARD_ERROR_OF_MEAN|3.71||0.1421|TWO_SIDED|90.0|-0.71|11.94|||t-test, 2 sided|||Lung, Right Middle Lobe Ventilation||11.94|-0.71|0.1421
72601016|NCT02634983|144730775|NON_INFERIORITY|Parameters were analyzed using mixed effects model including sequence, period, treatment as fixed factors and patient as random factor.|Mean Difference (Final Values)|7.73|STANDARD_ERROR_OF_MEAN|2.78||0.0099|TWO_SIDED|90.0|2.98|12.47|||t-test, 2 sided|||Lung, Right Upper Lobe Ventilation||12.47|2.98|0.0099
72601017|NCT02634983|144730776|NON_INFERIORITY|Parameters were analyzed using mixed effects model including sequence, period, treatment as fixed factors and patient as random factor.|Mean Difference (Final Values)|0.93|STANDARD_ERROR_OF_MEAN|0.92||0.323|TWO_SIDED|90.0|-0.64|2.5|||t-test, 2 sided|||Lung Perfusion||2.50|-0.64|0.3230
72601018|NCT02634983|144730776|NON_INFERIORITY|Parameters were analyzed using mixed effects model including sequence, period, treatment as fixed factors and patient as random factor.|Mean Difference (Final Values)|1.34|STANDARD_ERROR_OF_MEAN|0.95||0.1717|TWO_SIDED|90.0|-0.29|2.97|||t-test, 2 sided|||Lung, Left Perfusion||2.97|-0.29|0.1717
72601019|NCT02634983|144730776|NON_INFERIORITY|Parameters were analyzed using mixed effects model including sequence, period, treatment as fixed factors and patient as random factor.|Mean Difference (Final Values)|0.69|STANDARD_ERROR_OF_MEAN|1.02||0.5031|TWO_SIDED|90.0|-1.05|2.43|||t-test, 2 sided|||Lung, Left Lower Lobe Perfusion||2.43|-1.05|0.5031
72601020|NCT02634983|144730776|NON_INFERIORITY|Parameters were analyzed using mixed effects model including sequence, period, treatment as fixed factors and patient as random factor.|Mean Difference (Final Values)|1.9|STANDARD_ERROR_OF_MEAN|1.03||0.076|TWO_SIDED|90.0|0.15|3.65|||t-test, 2 sided|||Lung, Left Upper Lobe Perfusion||3.65|0.15|0.0760
72601021|NCT02634983|144730776|NON_INFERIORITY|Parameters were analyzed using mixed effects model including sequence, period, treatment as fixed factors and patient as random factor.|Mean Difference (Final Values)|0.57|STANDARD_ERROR_OF_MEAN|0.93||0.5465|TWO_SIDED|90.0|-1.02|2.16|||t-test, 2 sided|||Lung, Right Perfusion||2.16|-1.02|0.5465
72601022|NCT02634983|144730776|NON_INFERIORITY|Parameters were analyzed using mixed effects model including sequence, period, treatment as fixed factors and patient as random factor.|Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|1.08||0.9913|TWO_SIDED|90.0|-1.85|1.87|||t-test, 2 sided|||Lung, Right Lower Lobe Perfusion||1.87|-1.85|0.9913
72601023|NCT02634983|144730776|NON_INFERIORITY|Parameters were analyzed using mixed effects model including sequence, period, treatment as fixed factors and patient as random factor.|Mean Difference (Final Values)|1.51|STANDARD_ERROR_OF_MEAN|1.7||0.3837|TWO_SIDED|90.0|-1.39|4.4|||t-test, 2 sided|||Lung, Right Middle Lobe Perfusion||4.40|-1.39|0.3837
72601024|NCT02634983|144730776|NON_INFERIORITY|Parameters were analyzed using mixed effects model including sequence, period, treatment as fixed factors and patient as random factor.|Mean Difference (Final Values)|0.87|STANDARD_ERROR_OF_MEAN|0.94||0.3624|TWO_SIDED|90.0|-0.73|2.48|||t-test, 2 sided|||Lung, Right Upper Lobe Perfusion||2.48|-0.73|0.3624
72601025|NCT02634983|144730777|NON_INFERIORITY|Parameters were analyzed using mixed effects model including sequence, period, treatment, time and treatment\*Day\*time interaction term as fixed factors and patient factor as random factor. Day\*time was repeated within each patient\*period interaction and subject average baseline and period adjusted baseline were included as covariates.|Mean Difference (Final Values)|0.15|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001|TWO_SIDED|90.0|0.11|0.18|||t-test, 2 sided|||FEV1 Day 1 (0.25 hrs post-dose)||0.18|0.11|<0.0001
72601026|NCT02634983|144730777|NON_INFERIORITY|Parameters were analyzed using mixed effects model including sequence, period, treatment, time and treatment\*Day\*time interaction term as fixed factors and patient factor as random factor. Day\*time was repeated within each patient\*period interaction and subject average baseline and period adjusted baseline were included as covariates.|Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|0.03|<|0.0001|TWO_SIDED|90.0|0.15|0.25|||t-test, 2 sided|||FEV1 Day 1 (1 hrs post-dose)||0.25|0.15|<0.0001
72601027|NCT02634983|144730777|NON_INFERIORITY|Parameters were analyzed using mixed effects model including sequence, period, treatment, time and treatment\*Day\*time interaction term as fixed factors and patient factor as random factor. Day\*time was repeated within each patient\*period interaction and subject average baseline and period adjusted baseline were included as covariates.|Mean Difference (Final Values)|0.19|STANDARD_ERROR_OF_MEAN|0.03|<|0.0001|TWO_SIDED|90.0|0.13|0.24|||t-test, 2 sided|||FEV1 Day 1 (2 hrs post-dose)||0.24|0.13|<0.0001
72601028|NCT02634983|144730777|NON_INFERIORITY|Parameters were analyzed using mixed effects model including sequence, period, treatment, time and treatment\*Day\*time interaction term as fixed factors and patient factor as random factor. Day\*time was repeated within each patient\*period interaction and subject average baseline and period adjusted baseline were included as covariates.|Mean Difference (Final Values)|0.22|STANDARD_ERROR_OF_MEAN|0.03|<|0.0001|TWO_SIDED|90.0|0.16|0.27|||t-test, 2 sided|||FEV1 Day 8 (-0.75 hrs post-dose)||0.27|0.16|<0.0001
72601029|NCT02634983|144730777|NON_INFERIORITY|Parameters were analyzed using mixed effects model including sequence, period, treatment, time and treatment\*Day\*time interaction term as fixed factors and patient factor as random factor. Day\*time was repeated within each patient\*period interaction and subject average baseline and period adjusted baseline were included as covariates.|Mean Difference (Final Values)|0.22|STANDARD_ERROR_OF_MEAN|0.03|<|0.0001|TWO_SIDED|90.0|0.16|0.28|||t-test, 2 sided|||FEV1 Day 8 (-0.25 hrs post-dose)||0.28|0.16|<0.0001
72601030|NCT02634983|144730777|NON_INFERIORITY|Parameters were analyzed using mixed effects model including sequence, period, treatment, time and treatment\*Day\*time interaction term as fixed factors and patient factor as random factor. Day\*time was repeated within each patient\*period interaction and subject average baseline and period adjusted baseline were included as covariates.|Mean Difference (Final Values)|0.28|STANDARD_ERROR_OF_MEAN|0.03|<|0.0001|TWO_SIDED|90.0|0.23|0.33|||t-test, 2 sided|||FEV1 Day 8 (0.25 hrs post-dose)||0.33|0.23|<0.0001
72601031|NCT02634983|144730777|NON_INFERIORITY|Parameters were analyzed using mixed effects model including sequence, period, treatment, time and treatment\*Day\*time interaction term as fixed factors and patient factor as random factor. Day\*time was repeated within each patient\*period interaction and subject average baseline and period adjusted baseline were included as covariates.|Mean Difference (Final Values)|0.32|STANDARD_ERROR_OF_MEAN|0.03|<|0.0001|TWO_SIDED|90.0|0.26|0.37|||t-test, 2 sided|||FEV1 Day 8 (1 hrs post-dose)||0.37|0.26|<0.0001
72601032|NCT02634983|144730777|NON_INFERIORITY|Parameters were analyzed using mixed effects model including sequence, period, treatment, time and treatment\*Day\*time interaction term as fixed factors and patient factor as random factor. Day\*time was repeated within each patient\*period interaction and subject average baseline and period adjusted baseline were included as covariates.|Mean Difference (Final Values)|0.32|STANDARD_ERROR_OF_MEAN|0.04|<|0.0001|TWO_SIDED|90.0|0.26|0.38|||t-test, 2 sided|||FEV1 Day 8 (2 hrs post-dose)||0.38|0.26|<0.0001
72601033|NCT02634983|144730778|NON_INFERIORITY|Parameters were analyzed using mixed effects model including sequence, period, treatment, time and treatment\*Day\*time interaction term as fixed factors and patient factor as random factor. Day\*time was repeated within each patient\*period interaction and subject average baseline and period adjusted baseline were included as covariates.|Mean Difference (Final Values)|0.24|STANDARD_ERROR_OF_MEAN|0.05|<|0.0001|TWO_SIDED|90.0|0.15|0.33|||t-test, 2 sided|||FVC Day 1 (0.25 hrs post-dose)||0.33|0.15|<0.0001
72601034|NCT02634983|144730778|NON_INFERIORITY|Parameters were analyzed using mixed effects model including sequence, period, treatment, time and treatment\*Day\*time interaction term as fixed factors and patient factor as random factor. Day\*time was repeated within each patient\*period interaction and subject average baseline and period adjusted baseline were included as covariates.|Mean Difference (Final Values)|0.35|STANDARD_ERROR_OF_MEAN|0.06|<|0.0001|TWO_SIDED|90.0|0.25|0.45|||t-test, 2 sided|||FVC Day 1 (1 hrs post-dose)||0.45|0.25|<0.0001
72601035|NCT02634983|144730778|NON_INFERIORITY|Parameters were analyzed using mixed effects model including sequence, period, treatment, time and treatment\*Day\*time interaction term as fixed factors and patient factor as random factor. Day\*time was repeated within each patient\*period interaction and subject average baseline and period adjusted baseline were included as covariates.|Mean Difference (Final Values)|0.31|STANDARD_ERROR_OF_MEAN|0.07|<|0.0001|TWO_SIDED|90.0|0.2|0.42|||t-test, 2 sided|||FVC Day 1 (2 hrs post-dose)||0.42|0.20|<0.0001
72601036|NCT02634983|144730778|NON_INFERIORITY|Parameters were analyzed using mixed effects model including sequence, period, treatment, time and treatment\*Day\*time interaction term as fixed factors and patient factor as random factor. Day\*time was repeated within each patient\*period interaction and subject average baseline and period adjusted baseline were included as covariates.|Mean Difference (Final Values)|0.35|STANDARD_ERROR_OF_MEAN|0.06|<|0.001|TWO_SIDED|90.0|0.25|0.45|||t-test, 2 sided|||FVC Day 8 (-0.75 hrs post-dose)||0.45|0.25|<0.001
72601037|NCT02634983|144730778|NON_INFERIORITY|Parameters were analyzed using mixed effects model including sequence, period, treatment, time and treatment\*Day\*time interaction term as fixed factors and patient factor as random factor. Day\*time was repeated within each patient\*period interaction and subject average baseline and period adjusted baseline were included as covariates.|Mean Difference (Final Values)|0.28|STANDARD_ERROR_OF_MEAN|0.06|<|0.0001|TWO_SIDED|90.0|0.19|0.37|||t-test, 2 sided|||FVC Day 8 (-0.25 hrs post-dose)||0.37|0.19|<0.0001
72601038|NCT02634983|144730778|NON_INFERIORITY|Parameters were analyzed using mixed effects model including sequence, period, treatment, time and treatment\*Day\*time interaction term as fixed factors and patient factor as random factor. Day\*time was repeated within each patient\*period interaction and subject average baseline and period adjusted baseline were included as covariates.|Mean Difference (Final Values)|0.43|STANDARD_ERROR_OF_MEAN|0.06|<|0.0001|TWO_SIDED|90.0|0.33|0.53|||t-test, 2 sided|||FVC Day 8 (0.25 hrs post-dose)||0.53|0.33|<0.0001
72601039|NCT02634983|144730778|NON_INFERIORITY|Parameters were analyzed using mixed effects model including sequence, period, treatment, time and treatment\*Day\*time interaction term as fixed factors and patient factor as random factor. Day\*time was repeated within each patient\*period interaction and subject average baseline and period adjusted baseline were included as covariates.|Mean Difference (Final Values)|0.45|STANDARD_ERROR_OF_MEAN|0.06|<|0.0001|TWO_SIDED|90.0|0.36|0.54|||t-test, 2 sided|||FVC Day 8 (1 hrs post-dose)||0.54|0.36|<0.0001
72601040|NCT02634983|144730778|NON_INFERIORITY|Parameters were analyzed using mixed effects model including sequence, period, treatment, time and treatment\*Day\*time interaction term as fixed factors and patient factor as random factor. Day\*time was repeated within each patient\*period interaction and subject average baseline and period adjusted baseline were included as covariates.|Mean Difference (Final Values)|0.44|STANDARD_ERROR_OF_MEAN|0.06|<|0.0001|TWO_SIDED|90.0|0.33|0.55|||t-test, 2 sided|||FVC Day 8 (2 hrs post-dose)||0.55|0.33|<0.0001
72601041|NCT02634983|144730779|NON_INFERIORITY|Parameters were analyzed using mixed effects model including sequence, period, treatment, time and treatment\*Day\*time interaction term as fixed factors and patient factor as random factor. Day\*time was repeated within each patient\*period interaction and subject average baseline and period adjusted baseline were included as covariates.|Mean Difference (Final Values)|2.17|STANDARD_ERROR_OF_MEAN|0.56||0.0006|TWO_SIDED|90.0|1.21|3.12|||t-test, 2 sided|||FEV1/FVC Day 1 (0.25 hrs post-dose)||3.12|1.21|0.0006
72601042|NCT02634983|144730779|NON_INFERIORITY|Parameters were analyzed using mixed effects model including sequence, period, treatment, time and treatment\*Day\*time interaction term as fixed factors and patient factor as random factor. Day\*time was repeated within each patient\*period interaction and subject average baseline and period adjusted baseline were included as covariates.|Mean Difference (Final Values)|2.06|STANDARD_ERROR_OF_MEAN|0.75||0.0106|TWO_SIDED|90.0|0.78|3.33|||t-test, 2 sided|||FEV1/FVC Day 1 (1 hrs post-dose)||3.33|0.78|0.0106
72601043|NCT02634983|144730779|NON_INFERIORITY|Parameters were analyzed using mixed effects model including sequence, period, treatment, time and treatment\*Day\*time interaction term as fixed factors and patient factor as random factor. Day\*time was repeated within each patient\*period interaction and subject average baseline and period adjusted baseline were included as covariates.|Mean Difference (Final Values)|2.32|STANDARD_ERROR_OF_MEAN|0.66||0.0013|TWO_SIDED|90.0|1.2|3.44|||t-test, 2 sided|||FEV1/FVC Day 1 (2 hrs post-dose)||3.44|1.20|0.0013
72601044|NCT02634983|144730779|NON_INFERIORITY|Parameters were analyzed using mixed effects model including sequence, period, treatment, time and treatment\*Day\*time interaction term as fixed factors and patient factor as random factor. Day\*time was repeated within each patient\*period interaction and subject average baseline and period adjusted baseline were included as covariates.|Mean Difference (Final Values)|2.82|STANDARD_ERROR_OF_MEAN|0.83||0.0017|TWO_SIDED|90.0|1.41|4.23|||t-test, 2 sided|||FEV1/FVC Day 8 (-0.75 hrs post-dose)||4.23|1.41|0.0017
72601045|NCT02634983|144730779|NON_INFERIORITY|Parameters were analyzed using mixed effects model including sequence, period, treatment, time and treatment\*Day\*time interaction term as fixed factors and patient factor as random factor. Day\*time was repeated within each patient\*period interaction and subject average baseline and period adjusted baseline were included as covariates.|Mean Difference (Final Values)|3.8|STANDARD_ERROR_OF_MEAN|0.76|<|0.0001|TWO_SIDED|90.0|2.51|5.09|||t-test, 2 sided|||FEV1/FVC Day 8 (-0.25 hrs post-dose)||5.09|2.51|<0.0001
72601046|NCT02634983|144730779|NON_INFERIORITY|Parameters were analyzed using mixed effects model including sequence, period, treatment, time and treatment\*Day\*time interaction term as fixed factors and patient factor as random factor. Day\*time was repeated within each patient\*period interaction and subject average baseline and period adjusted baseline were included as covariates.|Mean Difference (Final Values)|3.74|STANDARD_ERROR_OF_MEAN|0.75|<|0.0001|TWO_SIDED|90.0|2.45|5.02|||t-test, 2 sided|||FEV1/FVC Day 8 (0.25 hrs post-dose)||5.02|2.45|<0.0001
72601047|NCT02634983|144730779|NON_INFERIORITY|Parameters were analyzed using mixed effects model including sequence, period, treatment, time and treatment\*Day\*time interaction term as fixed factors and patient factor as random factor. Day\*time was repeated within each patient\*period interaction and subject average baseline and period adjusted baseline were included as covariates.|Mean Difference (Final Values)|4.6|STANDARD_ERROR_OF_MEAN|0.85|<|0.0001|TWO_SIDED|90.0|3.16|6.03|||t-test, 2 sided|||FEV1/FVC Day 8 (1 hrs post-dose)||6.03|3.16|<0.0001
72601048|NCT02634983|144730779|NON_INFERIORITY|Parameters were analyzed using mixed effects model including sequence, period, treatment, time and treatment\*Day\*time interaction term as fixed factors and patient factor as random factor. Day\*time was repeated within each patient\*period interaction and subject average baseline and period adjusted baseline were included as covariates.|Mean Difference (Final Values)|4.98|STANDARD_ERROR_OF_MEAN|0.83|<|0.0001|TWO_SIDED|90.0|3.56|6.39|||t-test, 2 sided|||FEV1/FVC Day 8 (2 hrs post-dose)||6.39|3.56|<0.0001
72601049|NCT02634983|144730780|NON_INFERIORITY|Parameters were analyzed using mixed effects model including sequence, period, treatment as fixed factors and patient as random factor.|Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.36||0.982|TWO_SIDED|90.0|-0.62|0.6|||t-test, 2 sided|||Lung Clearance Index||0.60|-0.62|0.9820
72601050|NCT02634983|144730781|NON_INFERIORITY|Parameters were analyzed using mixed effects model including sequence, period, treatment as fixed factors and patient as random factor.|Mean Difference (Final Values)|0.66|STANDARD_ERROR_OF_MEAN|0.36||0.0821|TWO_SIDED|90.0|0.04|1.27|||t-test, 2 sided|||Diffusion Capacity of Lung for CO||1.27|0.04|0.0821
72601051|NCT03749109|144730800|OTHER||Difference in LS mean|1.74||||0.78|TWO_SIDED|95.0|-10.45|13.94|||ANCOVA|ANCOVA adjusted for baseline lesion size.||Endometrioma||13.94|-10.45|0.78
72601052|NCT03749109|144730800|OTHER||Difference in LS mean|3.35||||0.29|TWO_SIDED|95.0|-2.89|9.59|||ANCOVA|ANCOVA adjusted for baseline lesion size.||DIE||9.59|-2.89|0.29
72601053|NCT03749109|144730800|OTHER||Difference in LS mean|0.33||||0.95|TWO_SIDED|95.0|-10.33|10.99|||ANCOVA|ANCOVA adjusted for baseline lesion size.||Adenomyosis||10.99|-10.33|0.95
72601054|NCT03749109|144730801|OTHER||Difference in LS mean|-6.99||||0.65|TWO_SIDED|95.0|-36.8|22.82|||ANCOVA|ANCOVA adjusted for baseline lesion size.||Endometrioma||22.82|-36.80|0.65
72601055|NCT03749109|144730801|OTHER||Difference in LS mean|-1.13||||0.92|TWO_SIDED|95.0|-22.77|20.51|||ANCOVA|ANCOVA adjusted for baseline lesion size.||DIE||20.51|-22.77|0.92
72601056|NCT03749109|144730801|OTHER||Difference in LS mean|-5.92||||0.74|TWO_SIDED|95.0|-40.94|29.1|||ANCOVA|ANCOVA adjusted for baseline lesion size.||||29.10|-40.94|0.74
72601057|NCT03749109|144730802|OTHER||Odds Ratio (OR)|1.04||||0.95|TWO_SIDED|95.0|0.38|2.82|||Regression, Logistic|||Endometrioma||2.82|0.38|0.95
72601058|NCT03749109|144730802|OTHER||Odds Ratio (OR)|0.55||||0.39|TWO_SIDED|95.0|0.14|2.17|||Regression, Logistic|||Adenomyosis||2.17|0.14|0.39
72601059|NCT03749109|144730803|OTHER||Odds Ratio (OR)|0.7||||0.6|TWO_SIDED|95.0|0.19|2.65|||Regression, Logistic|||Endometrioma||2.65|0.19|0.60
72421625|NCT03720938|144354388|SUPERIORITY|||||||0.6328||||||Linear mixed-effects model fit by maximum likelihood since restricted maximum likelihood assumes a strong normality.|Linear mixed-effects model|Adjusted by Satterthwaite's degrees of freedom method for cluster effect, and small sample sizes in addition to baseline value and age.||Null hypothesis was the absence of difference between the two groups for the dependent variable self-perception of body attractiveness.||||0.63280
72601060|NCT03749109|144730803|OTHER||Odds Ratio (OR)|0.35||||0.21|TWO_SIDED|95.0|0.07|1.79|||Regression, Logistic|||Adenomyosis||1.79|0.07|0.21
72601061|NCT03749109|144730804|OTHER||Rate Ratio|2.53||||0.13|TWO_SIDED|95.0|0.76|8.39|||Negative-binomial regression|||Endometrioma - Disappearing Lesions||8.39|0.76|0.13
72601062|NCT03749109|144730804|OTHER||Rate Ratio|0.49||||0.56|TWO_SIDED|95.0|0.04|5.41|||Negative-binomial regression|||Adenomyosis - Disappearing Lesions||5.41|0.04|0.56
72601063|NCT03749109|144730805|OTHER||Difference in LS mean|0.23||||0.97|TWO_SIDED|95.0|-12.78|13.23|||ANCOVA|ANCOVA adjusted for baseline lesion size.||Endometrioma||13.23|-12.78|0.97
72601064|NCT03749109|144730805|OTHER||Difference in LS mean|0.72||||0.74|TWO_SIDED|95.0|-3.63|5.07|||ANCOVA|ANCOVA adjusted for baseline lesion size.||DIE||5.07|-3.63|0.74
72601065|NCT03749109|144730806|OTHER||Difference in LS mean|10.13||||0.42|TWO_SIDED|95.0|-14.74|35.0|||ANCOVA|ANCOVA adjusted for baseline lesion size.||||35.00|-14.74|0.42
72601066|NCT03749109|144730807|OTHER||Difference in LS mean|1.09||||0.1|TWO_SIDED|95.0|-0.2|2.38|||ANCOVA|ANCOVA adjusted for baseline lesion size.||Endometrioma||2.38|-0.20|0.10
72601067|NCT03749109|144730807|OTHER||Difference in LS mean|0.28||||0.67|TWO_SIDED|95.0|-1.02|1.58|||ANCOVA|ANCOVA adjusted for baseline lesion size.||DIE||1.58|-1.02|0.67
72601068|NCT03749109|144730807|OTHER||Difference in LS mean|0.32||||0.64|TWO_SIDED|95.0|-1.06|1.71|||ANCOVA|ANCOVA adjusted for baseline lesion size.||Adenomyosis||1.71|-1.06|0.64
72601069|NCT03749109|144730808|OTHER||Difference in LS mean|0.21||||0.73|TWO_SIDED|95.0|-1.02|1.44|||ANCOVA|ANCOVA adjusted for baseline lesion size.||Endometrioma at cycle 1||1.44|-1.02|0.73
72601070|NCT03749109|144730808|OTHER||Difference in LS mean|0.42||||0.54|TWO_SIDED|95.0|-0.97|1.82|||ANCOVA|ANCOVA adjusted for baseline lesion size.||Endometrioma at cycle 2||1.82|-0.97|0.54
72601071|NCT03749109|144730808|OTHER||Difference in LS mean|-0.5||||0.46|TWO_SIDED|95.0|-1.86|0.85|||ANCOVA|ANCOVA adjusted for baseline lesion size.||Endometrioma at cycle 3||0.85|-1.86|0.46
72601072|NCT03749109|144730808|OTHER||Difference in LS mean|0.53||||0.49|TWO_SIDED|95.0|-0.99|2.05|||ANCOVA|ANCOVA adjusted for baseline lesion size.||Endometrioma at cycle 4||2.05|-0.99|0.49
72601073|NCT03749109|144730808|OTHER||Difference in LS mean|-0.01||||0.99|TWO_SIDED|95.0|-1.32|1.3|||ANCOVA|ANCOVA adjusted for baseline lesion size.||DIE at cycle 1||1.30|-1.32|0.99
72601074|NCT03749109|144730808|OTHER||Difference in LS mean|0.17||||0.83|TWO_SIDED|95.0|-1.38|1.71|||ANCOVA|ANCOVA adjusted for baseline lesion size.||DIE at cycle 2||1.71|-1.38|0.83
72601075|NCT03749109|144730808|OTHER||Difference in LS mean|-0.74||||0.28|TWO_SIDED|95.0|-2.11|0.63|||ANCOVA|ANCOVA adjusted for baseline lesion size.||DIE at cycle 3||0.63|-2.11|0.28
72601076|NCT03749109|144730808|OTHER||Difference in LS mean|0.75||||0.26|TWO_SIDED|95.0|-0.57|2.07|||ANCOVA|ANCOVA adjusted for baseline lesion size.||DIE at cycle 4||2.07|-0.57|0.26
72601077|NCT03749109|144730808|OTHER||Difference in LS mean|0.91||||0.19|TWO_SIDED|95.0|-0.49|2.31|||ANCOVA|ANCOVA adjusted for baseline lesion size.||Adenomyosis at cycle 1||2.31|-0.49|0.19
72601078|NCT03749109|144730808|OTHER||Difference in LS mean|0.07||||0.93|TWO_SIDED|95.0|-1.45|1.58|||ANCOVA|ANCOVA adjusted for baseline lesion size.||Adenomyosis at cycle 2||1.58|-1.45|0.93
72601079|NCT03749109|144730808|OTHER||Difference in LS mean|-0.13||||0.85|TWO_SIDED|95.0|-1.58|1.32|||ANCOVA|ANCOVA adjusted for baseline lesion size.||Adenomyosis at cycle 3||1.32|-1.58|0.85
72601080|NCT03749109|144730808|OTHER||Difference in LS mean|0.01||||0.99|TWO_SIDED|95.0|-1.68|1.69|||ANCOVA|ANCOVA adjusted for baseline lesion size.||Adenomyosis at cycle 4||1.69|-1.68|0.99
72601081|NCT03749109|144730809|OTHER||Difference in LS mean|-7.35||||0.75|TWO_SIDED|95.0|-53.97|39.27|||ANCOVA|ANCOVA adjusted for baseline lesion size.||Endometrioma at cycle 2||39.27|-53.97|0.75
72601082|NCT03749109|144730809|OTHER||Difference in LS mean|17.31||||0.42|TWO_SIDED|95.0|-25.41|60.04|||ANCOVA|ANCOVA adjusted for baseline lesion size.||Endometrioma at cycle 4||60.04|-25.41|0.42
72601083|NCT03749109|144730809|OTHER||Difference in LS mean|-17.66||||0.47|TWO_SIDED|95.0|-66.3|30.98|||ANCOVA|ANCOVA adjusted for baseline lesion size.||DIE at cycle 2||30.98|-66.30|0.47
72601084|NCT03749109|144730809|OTHER||Difference in LS mean|25.61||||0.27|TWO_SIDED|95.0|-21.05|72.27|||ANCOVA|ANCOVA adjusted for baseline lesion size.||DIE at cycle 4||72.27|-21.05|0.27
72601085|NCT03749109|144730809|OTHER||Difference in LS mean|-20.95||||0.41|TWO_SIDED|95.0|-71.83|29.92|||ANCOVA|ANCOVA adjusted for baseline lesion size.||Adenomyosis at cycle 2||29.92|-71.83|0.41
72601086|NCT03749109|144730809|OTHER||Difference in LS mean|2.25||||0.93|TWO_SIDED|95.0|-49.57|54.06|||ANCOVA|ANCOVA adjusted for baseline lesion size.||Adenomyosis at cycle 4||54.06|-49.57|0.93
72601087|NCT03951753|144730859|OTHER||Least Squares Mean Difference|1.08|STANDARD_ERROR_OF_MEAN|0.107|<|0.001|TWO_SIDED|95.0|0.87|1.29|||ANCOVA|Data were analysed with ANCOVA in log transformed data.|Data were analysed with ANCOVA in log transformed data. Results were converted back to original scale.|||1.29|0.87|<0.001
72601088|NCT03951753|144730859|OTHER||Least Squares Mean Difference|1.92|STANDARD_ERROR_OF_MEAN|0.166|<|0.001|TWO_SIDED|95.0|1.59|2.24|||ANCOVA|Data were analysed with ANCOVA in log transformed data.|Data were analysed with ANCOVA in log transformed data. Results were converted back to original scale.|||2.24|1.59|<0.001
72601089|NCT03951753|144730859|OTHER||Least Squares Mean Difference|0.84|STANDARD_ERROR_OF_MEAN|0.192|<|0.001|TWO_SIDED|95.0|0.46|1.21|||ANCOVA|Data were analysed with ANCOVA in log transformed data.|Data were analysed with ANCOVA in log transformed data. Results were converted back to original scale.|||1.21|0.46|<0.001
72601090|NCT03951753|144730860|OTHER||Least Squares Mean Difference|-38.1|||<|0.001|TWO_SIDED|95.0|-45.4|-30.7|||ANCOVA|||||-30.7|-45.4|<0.001
72601091|NCT03951753|144730860|OTHER||Least Squares Mean Difference|-47.1|||<|0.001|TWO_SIDED|95.0|-54.6|-39.5|||ANCOVA|||||-39.5|-54.6|<0.001
72601092|NCT03951753|144730860|OTHER||Least Squares Mean Difference|-9.0||||0.006|TWO_SIDED|95.0|-15.4|-2.6|||ANCOVA|||||-2.6|-15.4|0.006
72601093|NCT03951753|144730861|OTHER||Least Squares Mean Difference|-14696.1|||<|0.001|TWO_SIDED|95.0|-17045.0|-12347.3|||ANCOVA|||||-12347.3|-17045.0|<0.001
72601094|NCT03951753|144730861|OTHER||Least Squares Mean Difference|-17873.2|||<|0.001|TWO_SIDED|95.0|-20239.0|-15507.4|||ANCOVA|||||-15507.4|-20239.0|<0.001
72601095|NCT03951753|144730861|OTHER||Least Squares Mean Difference|-3177.1||||0.002|TWO_SIDED|95.0|-5194.3|-1159.8|||ANCOVA|||||-1159.8|-5194.3|0.002
72601096|NCT03951753|144730862|OTHER||Least Squares Mean Difference|-1.93|||<|0.001|TWO_SIDED|95.0|-2.18|-1.67|||Mixed Models Analysis|||||-1.67|-2.18|<0.001
72601097|NCT03951753|144730862|OTHER||Least Squares Mean Difference|-2.33|||<|0.001|TWO_SIDED|95.0|-2.58|-2.08|||Mixed Models Analysis|||||-2.08|-2.58|<0.001
72601098|NCT03951753|144730862|OTHER||Least Squares Mean Difference|-0.41|||<|0.001|TWO_SIDED|95.0|-0.63|-0.19|||Mixed Models Analysis|||||-0.19|-0.63|<0.001
72601099|NCT03951753|144730863|OTHER||Least Squares Mean Difference|279.14|STANDARD_ERROR_OF_MEAN|17.366|<|0.001|TWO_SIDED|95.0|245.1|313.18|||ANCOVA|Data were analysed with ANCOVA in log transformed data.|Data were analysed with ANCOVA in log transformed data. Results were converted back to original scale.|||313.18|245.10|<0.001
72601100|NCT03951753|144730863|OTHER||Least Squares Mean Difference|381.23|STANDARD_ERROR_OF_MEAN|21.399|<|0.001|TWO_SIDED|95.0|339.29|423.17|||ANCOVA|Data were analysed with ANCOVA in log transformed data.|Data were analysed with ANCOVA in log transformed data. Results were converted back to original scale.|||423.17|339.29|<0.001
72601101|NCT03951753|144730863|OTHER||Least Squares Mean Difference|102.09|STANDARD_ERROR_OF_MEAN|25.635|<|0.001|TWO_SIDED|95.0|51.84|152.33|||ANCOVA|Data were analysed with ANCOVA in log transformed data.|Data were analysed with ANCOVA in log transformed data. Results were converted back to original scale.|||152.33|51.84|<0.001
72601102|NCT03951753|144730864|OTHER||Least Squares Mean Difference|11.3|||<|0.001|TWO_SIDED|95.0|4.9|17.7|||ANCOVA|||||17.7|4.9|<0.001
72601103|NCT03951753|144730864|OTHER||Least Squares Mean Difference|19.8|||<|0.001|TWO_SIDED|95.0|13.4|26.1|||ANCOVA|||||26.1|13.4|<0.001
72601104|NCT03951753|144730864|OTHER||Least Squares Mean Difference|8.5||||0.003|TWO_SIDED|95.0|3.0|14.0|||ANCOVA|||||14.0|3.0|0.003
72601105|NCT03951753|144730865|OTHER||Least Squares Mean Difference|-3.6|||<|0.001|TWO_SIDED|95.0|-5.5|-1.8|||ANCOVA|||||-1.8|-5.5|<0.001
72601106|NCT03951753|144730865|OTHER||Least Squares Mean Difference|-4.5|||<|0.001|TWO_SIDED|95.0|-6.3|-2.6|||ANCOVA|||||-2.6|-6.3|<0.001
72601107|NCT03951753|144730865|OTHER||Least Squares Mean Difference|-0.8||||0.277|TWO_SIDED|95.0|-2.4|0.7|||ANCOVA|||||0.7|-2.4|0.277
72601108|NCT03951753|144730866|OTHER||Slope|-296.1||||0.044|TWO_SIDED|95.0|-584.8|-7.5|||ANCOVA|||||-7.5|-584.8|0.044
72601109|NCT03951753|144730866|OTHER||Least Squares Mean Difference|-637.7|||<|0.001|TWO_SIDED|95.0|-925.2|-350.2|||ANCOVA|||||-350.2|-925.2|<0.001
72601110|NCT03951753|144730866|OTHER||Least Squares Mean Difference|-341.6||||0.006|TWO_SIDED|95.0|-585.2|-97.9|||ANCOVA|||||-97.9|-585.2|0.006
72601111|NCT03951753|144730867|OTHER||Least Squares Mean Difference|-245.5|||<|0.001|TWO_SIDED|95.0|-357.7|-133.3|||Mixed Models Analysis|||||-133.3|-357.7|<0.001
72601112|NCT03951753|144730867|OTHER||Least Squares Mean Difference|-309.8|||<|0.001|TWO_SIDED|95.0|-423.0|-196.6|||Mixed Models Analysis|||||-196.6|-423.0|<0.001
72601113|NCT03951753|144730867|OTHER||Least Squares Mean Difference|-64.3||||0.187|TWO_SIDED|95.0|-160.3|31.7|||Mixed Models Analysis|||||31.7|-160.3|0.187
72601114|NCT04633291|144730868|NON_INFERIORITY|Based on previous studies, the weighted average VAS discomfort level in healthy subjects using SpeediCath®Standard Male was estimated at 2.3 cm, with 50% increase in VAS was considered clinically relevant. The mean difference non-inferiority margin between catheter coatings was therefore set to 1.2 cm, and non-inferiority was demonstrated if the mean difference was not above 1.2 cm.|Mean Difference (Final Values)|0.04||||0.88|TWO_SIDED|95.0|-0.5|0.58||The threshold for statistical significance was set at 0.05|Mixed Models Analysis|Random effect: 'Subject'. Fixed effect: 'Visit' (Visit 1 and 2) and 'Treatment' (original coating and novel coating). Age was included as covariate.||At a 85% power level, the sample size needed to demonstrate non-inferiority of the novel coating to the original the coating was 18 subjects (participants). This was based on a standard deviation of 1.6 cm, a within subject correlation of 0.5 cm, and an assumption of same VAS distribution for the investigational device as for the comparator. With an expected drop-out rate of 20%, 22 subjects were included.||0.58|-0.50|0.88
72416161|NCT00464815|144343177|NON_INFERIORITY|Criterion for non-inferiority: the lower limit (LL) of the 2-sided standardized asymptotic 95% confidence interval for the group difference \[Nimenrix Group minus Mencevax ACWY Group\] in the percentage of subjects with bactericidal vaccine response was greater than or equal to (≥) the pre-defined clinical limit of -10%.|Rate difference|8.9|||||TWO_SIDED|95.0|4.78|14.14||||||To demonstrate the non-inferiority of Nimenrix vaccine versus Mencevax ACWY vaccine in term of rSBA-MenW-135 vaccine response, the standardized asymptotic 95% CI for the difference in rSBA vaccine response rate for the meningococcal serogroup W-135 (Nimenrix Group rate minus Mencevax ACWY Group rate) one month after vaccination was computed.||14.14|4.78|
72601115|NCT04633291|144730869|NON_INFERIORITY|Based on previous studies, the weighted average VAS discomfort level in healthy subjects using SpeediCath®Standard male was estimated at 2.3 cm, with 50% increase in VAS was considered clinically relevant. The mean difference non-inferiority margin between catheter coatings was therefore set to 1.2 cm, and non-inferiority was demonstrated if the mean difference was not above 1.2 cm.|Mean Difference (Final Values)|-0.14||||0.62|TWO_SIDED|95.0|-0.72|0.44||The threshold for statistical significance was set at 0.05.|Mixed Models Analysis|Random effect: 'Subject'. Fixed effect: 'Visit' (Visit 1 and 2) and 'Treatment' (original coating and novel coating). Age was included as covariate.||At a 85% power level, the sample size needed to demonstrate non-inferiority of the novel coating to the original the coating was 18 subjects (participants). This was based on a standard deviation of 1.6 cm, a within subject correlation of 0.5 cm, and an assumption of same VAS distribution for the investigational device as for the comparator. With an expected drop-out rate of 20%, 22 subjects were included.||0.44|-0.72|0.62
72601116|NCT04633291|144730870|NON_INFERIORITY|Based on previous studies, the weighted average VAS discomfort level in healthy subjects using SpeediCath®Standard male was estimated at 2.3 cm, with 50% increase in VAS was considered clinically relevant. The mean difference non-inferiority margin between catheter coatings was therefore set to 1.2 cm, and non-inferiority was demonstrated if the mean difference was not above 1.2 cm.|Mean Difference (Final Values)|0.11||||0.63|TWO_SIDED|95.0|-0.36|0.57||The threshold for statistical significance was set at 0.05.|Mixed Models Analysis|Random effect: 'Subject'. Fixed effect: 'Visit' (Visit 1 and 2) and 'Treatment' (original coating and novel coating). Age was included as covariate.||At a 85% power level, the sample size needed to demonstrate non-inferiority of the novel coating to the original the coating was 18 subjects (participants). This was based on a standard deviation of 1.6 cm, a within subject correlation of 0.5 cm, and an assumption of same VAS distribution for the investigational device as for the comparator. With an expected drop-out rate of 20%, 22 subjects were included.||0.57|-0.36|0.63
72601117|NCT04633291|144730871|NON_INFERIORITY|Based on previous studies, the weighted average VAS discomfort level in healthy subjects using SpeediCath®Standard male was estimated at 2.3 cm, with 50% increase in VAS was considered clinically relevant. The mean difference non-inferiority margin between catheter coatings was therefore set to 1.2 cm, and non-inferiority was demonstrated if the mean difference was not above 1.2 cm.|Mean Difference (Final Values)|-0.15||||0.19|TWO_SIDED|95.0|-0.38|0.08||The threshold for statistical significance was set at 0.05.|Mixed Models Analysis|Random effect: 'Subject'. Fixed effect: 'Visit' (Visit 1 and 2) and 'Treatment' (original coating and novel coating). Age was included as covariate.||At a 85% power level, the sample size needed to demonstrate non-inferiority of the novel coating to the original the coating was 18 subjects (participants). This was based on a standard deviation of 1.6 cm, a within subject correlation of 0.5 cm, and an assumption of same VAS distribution for the investigational device as for the comparator. With an expected drop-out rate of 20%, 22 subjects were included.||0.08|-0.38|0.19
72601118|NCT04633291|144730872|SUPERIORITY||Odds Ratio (OR)|1.76||||0.381|TWO_SIDED|95.0|0.47|6.6||The threshold for statistical significance was set at 0.05.|Proportional odds model|Random effect: 'Subject'. Fixed effect: 'Visit' (Visit 1 and 2) and 'Treatment' (original coating and novel coating). Age was included as covariate.|OR=1 corresponds to exact equality. OR \>1 means that the investigational device is evaluated easier than the comparator. OR \<1 means that the comparator device is evaluated easier than the investigational device.|Null hypothesis: No difference between the devices.||6.60|0.47|0.381
72601119|NCT04633291|144730873|SUPERIORITY||Odds Ratio (OR)|7.8||||0.541|TWO_SIDED|95.0|-18.4|34.0||The threshold for statistical significance was set at 0.05.|Proportional odds model|Random effect: 'Subject'. Fixed effect: 'Visit' (Visit 1 and 2) and 'Treatment' (original coating and novel coating). Age was included as covariate.|"OR=1 corresponds to exact equality. OR \>1 means that the investigational device is evaluated easier than the comparator. OR \<1 means that the comparator device is evaluated easier than the investigational device.~Of note: Log transformed estimates."|Null hypothesis: No difference between the devices.||34.00|-18.40|0.541
72601120|NCT04633291|144730874|SUPERIORITY||Odds Ratio (OR)|7.17||||0.269|TWO_SIDED|95.0|0.19|265.95||The threshold for statistical significance was set at 0.05.|Regression, Logistic|Random effect: 'Subject'. Fixed effect: 'Visit' (Visit 1 and 2) and 'Treatment' (original coating and novel coating). Age was included as covariate.|OR=1 corresponds to exact equality. OR \>1 means that the investigational device is in favor compared to the comparator. OR \<1 means that the comparator device is in favor compared to the investigational device.|Null hypothesis: No difference between the devices.||265.95|0.19|0.269
72601121|NCT04633291|144730875|SUPERIORITY||Odds Ratio (OR)|1.0||||1|TWO_SIDED|95.0|0.02|64.83||The threshold for statistical significance was set at 0.05.|Regression, Logistic|Random effect: 'Subject'. Fixed effect: 'Visit' (Visit 1 and 2) and 'Treatment' (original coating and novel coating). Age was included as covariate.|OR=1 corresponds to exact equality. OR \>1 means that the investigational device is in favor compared to the comparator. OR \<1 means that the comparator device is in favor compared to the investigational device.|Null hypothesis: No difference between the devices.||64.83|0.02|1.0
72601122|NCT04633291|144730876|SUPERIORITY||Odds Ratio (OR)|1.0||||1|TWO_SIDED|95.0|0.08|12.87||The threshold for statistical significance was set at 0.05.|Regression, Logistic|Random effect: 'Subject'. Fixed effect: 'Visit' (Visit 1 and 2) and 'Treatment' (original coating and novel coating). Age was included as covariate.|OR=1 corresponds to exact equality. OR \>1 means that the investigational device is in favor compared to the comparator. OR \<1 means that the comparator device is in favor compared to the investigational device.|Null hypothesis: No difference between the devices.||12.87|0.08|1.0
72601123|NCT00076258|144730877|SUPERIORITY_OR_OTHER_LEGACY||Remission rate|29.5|||<|0.05|TWO_SIDED||||||Generalized Linear Mixed Model|Both unadjusted and adjusted rates (for significant covariates) were reported||||||<0.05
72601124|NCT00076258|144730877|SUPERIORITY_OR_OTHER_LEGACY||Remission Rate|28.3|||<|0.05|TWO_SIDED||||||Generalized Linear Mixed Model|||For the covariate adjusted GLMM the remission rates were 15.5 for the LD and 28.3 for the PHD with a p \< 0.06 and the NNT of 7.8 for the PHD versus the LD.||||<0.05
72601125|NCT02371668|144730926|SUPERIORITY|||||||0.31|||||||Wilcoxon (Mann-Whitney)|||||||0.31
72601126|NCT02371668|144730927|SUPERIORITY|||||||0.114|||||||Fisher Exact|||||||0.114
72601127|NCT02371668|144730928|SUPERIORITY|||||||0.4989|||||||Wilcoxon (Mann-Whitney)|||||||0.4989
72601128|NCT02371668|144730929|SUPERIORITY|||||||0.1412|||||||Wilcoxon (Mann-Whitney)|||||||0.1412
72601129|NCT02371668|144730930|SUPERIORITY|||||||0.137|||||||Fisher Exact|||||||0.137
72601130|NCT02371668|144730931|SUPERIORITY|||||||0.2445|||||||Wilcoxon (Mann-Whitney)|||||||0.2445
72601131|NCT02371668|144730932|SUPERIORITY|||||||0.045|||||||Fisher Exact|||||||0.045
72601132|NCT02371668|144730933|SUPERIORITY|||||||0.23|||||||Wilcoxon (Mann-Whitney)|||||||0.230
72601133|NCT02371668|144730934|SUPERIORITY|||||||0.646|||||||Fisher Exact|||||||0.646
72601134|NCT00398216|144730939|SUPERIORITY_OR_OTHER|||||||0.003|TWO_SIDED||||||Fisher Exact|||||||0.003
72601135|NCT00398216|144730939|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Fisher Exact|||||||<0.001
72601136|NCT00398216|144730939|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Fisher Exact|||||||<0.001
72601137|NCT00398216|144730939|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Fisher Exact|||||||<0.001
72601138|NCT00398216|144730942|SUPERIORITY_OR_OTHER|||||||0.25|TWO_SIDED||||||Fisher Exact|||||||.250
72601139|NCT00398216|144730942|SUPERIORITY_OR_OTHER|||||||0.122|TWO_SIDED||||||Fisher Exact|||||||.122
72601140|NCT00398216|144730942|SUPERIORITY_OR_OTHER|||||||0.124|TWO_SIDED||||||Fisher Exact|||||||.124
72601141|NCT00398216|144730942|SUPERIORITY_OR_OTHER|||||||0.123|TWO_SIDED||||||Fisher Exact|||||||.123
72601142|NCT01048944|144730943|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|||||P values are adjusted for multiple comparisons except for specific a priori directional predictions.|Mixed Models Analysis|||Mixed-model repeated measures multivariate analyses of variance assessed Treatment x Day of abstinence (days 3, 24, 45, and 66) based on changes from pre-quit baseline to values of the four post-quit time points (days 3, 24, 45, and 66).||||<0.05
72601143|NCT02207400|144730948|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-11.612|||<|0.0001|TWO_SIDED|95.0|-13.191|-10.033|||ANCOVA||Difference is Sodium Bicarbonate and Sodium Fluoride Dentifrice minus Sodium Fluoride Dentifrice such that a negative difference favors the first named treatment.|||-10.033|-13.191|<0.0001
72601144|NCT02207400|144730949|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.652|||<|0.0001|TWO_SIDED|95.0|-0.738|-0.566|||ANCOVA||Difference is Sodium Bicarbonate and Sodium Fluoride Dentifrice minus Sodium Fluoride Dentifrice such that a negative difference favors the first named treatment.|||-0.566|-0.738|<0.0001
72601145|NCT02362425|144730978|SUPERIORITY|An a priori power calculation, with power at 80% and a two-sided α of 0·05, determined that n=76 participants (n=38 per group) would be required to detect a statistically significant post-intervention difference in plasma glutathione (GSH) concentration between NAC and placebo groups. After the primary endpoint was changed, re-evaluation of the sample size determined that a larger sample (total n=182) would be required. As per protocol, the study was completed at this time.|Mean Difference (Final Values)|0.1||||0.88|TWO_SIDED|95.0|-1.4|1.6|||Regression, Linear|Model comparing 12 m corrected 15-F2t-isoprostane conc. controlling for pre-intervention value. Investigated covariates: smoking and drinking status.||Null Hypothesis: In RYR1-RM myopathy patients, there will be no statistically significant difference in corrected 15-F2t-isoprostane concentration and/or corrected 15=f2t-Isop:PGR2alpha ratio between NAC and placebo groups at month 12, after controlling for established a priori confounders.||1.6|-1.4|0.88
72601146|NCT02362425|144730979|SUPERIORITY||Mean Difference (Final Values)|23.9||||0.11|TWO_SIDED|95.0|-5.5|53.4||Model controlled for six-month(pre-intervention) distance and treatment group. Investigated covariates: height|Regression, Linear|||In RYR1-RM myopathy patients, there will be no statistically significant difference in 6MWT (six minute walk test) total distance between NAC and placebo groups at month 12, after controlling for established a priori confounders.||53.4|-5.5|.11
72601147|NCT02362425|144730980|SUPERIORITY||Mean Difference (Final Values)|-1.5||||0.14|TWO_SIDED|95.0|-3.6|0.7|||Regression, Linear|||||0.7|-3.6|0.14
72601148|NCT02362425|144730981|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.62|TWO_SIDED|95.0|-0.5|0.3|||t-test, 2 sided|||||0.3|-0.5|0.62
72601149|NCT02362425|144730982|SUPERIORITY||Mean Difference (Final Values)|-0.5||||0.05|TWO_SIDED|95.0|-1.1|0.0|||t-test, 2 sided|||||0.0|-1.1|0.05
72601150|NCT02362425|144730983|SUPERIORITY||Mean Difference (Final Values)|-0.8||||0.25|TWO_SIDED|95.0|-2.1|0.6|||t-test, 2 sided|||||0.6|-2.1|0.25
72601151|NCT02362425|144730984|SUPERIORITY||Mean Difference (Final Values)|-1.1||||0.05|TWO_SIDED|95.0|-2.1|0.0|||t-test, 2 sided|||||0.0|-2.1|0.05
72601152|NCT02362425|144730985|SUPERIORITY||Mean Difference (Final Values)|3.4||||0.09|TWO_SIDED|95.0|-0.6|7.3|||t-test, 2 sided|||||7.3|-0.6|0.09
72601153|NCT02362425|144730986|SUPERIORITY||Mean Difference (Final Values)|0.3||||0.69|TWO_SIDED|95.0|-1.3|2.0|||t-test, 2 sided|||||2.0|-1.3|0.69
72601154|NCT02362425|144730987|SUPERIORITY||Mean Difference (Final Values)|-1.2||||0.31|TWO_SIDED|95.0|-3.5|1.1|||t-test, 2 sided|||||1.1|-3.5|0.31
72601155|NCT02362425|144730988|SUPERIORITY||Mean Difference (Final Values)|1.1||||0.22|TWO_SIDED|95.0|-0.8|3.0|||t-test, 2 sided|||||3.0|-0.8|0.22
72601156|NCT02362425|144730989|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.93|TWO_SIDED|95.0|-2.6|2.4|||t-test, 2 sided|||||2.4|-2.6|0.93
72601157|NCT02362425|144730990|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.66|TWO_SIDED|95.0|-1.3|0.8|||t-test, 2 sided|||||0.8|-1.3|0.66
72601158|NCT02362425|144730991|SUPERIORITY||Mean Difference (Final Values)|2.1||||0.09|TWO_SIDED|95.0|-0.4|4.6|||t-test, 2 sided|||||4.6|-0.4|0.09
72601159|NCT02362425|144730992|SUPERIORITY||Mean Difference (Final Values)|4.2||||0.09|TWO_SIDED|95.0|-0.7|9.0|||t-test, 2 sided|||||9.0|-0.7|0.09
72601160|NCT02362425|144730993|SUPERIORITY||Mean Difference (Final Values)|-5.5||||0.15|TWO_SIDED|95.0|-13.4|2.4|||t-test, 2 sided|||||2.4|-13.4|0.15
72601161|NCT02362425|144730994|SUPERIORITY||Mean Difference (Final Values)|-6.4||||0.08|TWO_SIDED|95.0|-13.7|1.0|||t-test, 2 sided|||||1.0|-13.7|0.08
72601162|NCT02362425|144730995|SUPERIORITY||Mean Difference (Final Values)|-16.27||||0.39|TWO_SIDED|95.0|-80.1|47.5|||t-test, 2 sided|||||47.5|-80.1|0.39
72601163|NCT02362425|144730996|SUPERIORITY||Mean Difference (Final Values)|10.0||||0.57|TWO_SIDED|95.0|-59.5|39.5|||t-test, 2 sided|||||39.5|-59.5|0.57
72601164|NCT02362425|144730997|SUPERIORITY||Mean Difference (Final Values)|-2.1||||0.12|TWO_SIDED|95.0|-5.0|0.6|||t-test, 2 sided|||||0.6|-5.0|0.12
72601165|NCT02362425|144730998|SUPERIORITY||Mean Difference (Final Values)|-0.5||||0.76|TWO_SIDED|95.0|-3.6|2.7|||t-test, 2 sided|||||2.7|-3.6|0.76
72601166|NCT02362425|144730999|SUPERIORITY||Mean Difference (Final Values)|0.5||||0.72|TWO_SIDED|95.0|-2.5|3.5|||t-test, 2 sided|||||3.5|-2.5|0.72
72601167|NCT02362425|144731000|SUPERIORITY||Mean Difference (Final Values)|0.4||||0.7|TWO_SIDED|95.0|-1.8|2.7|||t-test, 2 sided|||||2.7|-1.8|0.70
72601168|NCT02362425|144731001|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.88|TWO_SIDED|95.0|-2.8|3.3|||t-test, 2 sided|||||3.3|-2.8|0.88
72601169|NCT02362425|144731002|SUPERIORITY||Mean Difference (Final Values)|2.5||||0.61|TWO_SIDED|95.0|-10.3|15.2|||t-test, 2 sided|||||15.2|-10.3|0.61
72601170|NCT02362425|144731003|SUPERIORITY||Mean Difference (Final Values)|0.6||||0.87|TWO_SIDED|95.0|-7.4|8.5|||t-test, 2 sided|||||8.5|-7.4|0.87
72601171|NCT02362425|144731004|SUPERIORITY||Mean Difference (Final Values)|-12.5||||0.28|TWO_SIDED|95.0|-38.9|13.9|||t-test, 2 sided|||||13.9|-38.9|0.28
72601172|NCT02688764|144731039|SUPERIORITY|||||||0.1465||||||0.05 level of significance|t-test, 2 sided|||Results are obtained from a linear mixed model which includes change in serum phosphorus levels from baseline to the end of Stage 1 as dependent variable and treatment, baseline serum phosphorus, age (in categories) at randomisation, region (Non-US/US) and gender as fixed effects.||||0.1465
72601173|NCT02688764|144731042|SUPERIORITY|||||||0.0872||||||0.05 level of significance|t-test, 2 sided|||Results are obtained from a linear mixed model which includes change in serum phosphorus levels from baseline to the end of Stage 1 as dependent variable and treatment, baseline serum phosphorus, age (in categories) at randomisation, region (Non-US/US) and gender as fixed effects||||0.0872
72601174|NCT02688764|144731043|SUPERIORITY|||||||0.6207||||||0.05 level of significance|t-test, 2 sided|||Results are obtained from a linear mixed model which includes change in serum phosphorus levels from baseline to the end of Stage 2 as dependent variable and treatment, baseline serum phosphorus, age (in categories) at randomisation, region (Non-US/US) and gender as fixed effects.||||0.6207
72601175|NCT02688764|144731043|SUPERIORITY|||||||0.3226||||||0.05 level of significance|t-test, 2 sided|||Results are obtained from a linear mixed model which includes change in serum phosphorus levels from baseline to the end of Stage 2 as dependent variable and treatment, baseline serum phosphorus, age (in categories) at randomisation, region (Non-US/US) and gender as fixed effects.||||0.3226
72421626|NCT03720938|144354389|SUPERIORITY|||||||0.007061||||||The outcome of self-perception of global physical self-worth was tested for any difference between groups by covariate analysis.|ANCOVA|Adjusted for self-perception for global physical self-worth at baseline and confounding variable age.||Null hypothesis was the absence of difference between the two groups for the dependent variable self-perception of global physical self-worth.||||0.007061
72601176|NCT02688764|144731061|SUPERIORITY|||||||0.5682||||||0.05 level of significance|t-test, 2 sided|||"Age group of \>=2 years to \<6 years~Results are obtained from a linear mixed model which includes change in serum phosphorus levels from baseline to the end of Stage 1 as dependent variable and treatment, baseline serum phosphorus, age (in categories) at randomisation, region (Non-US/US) and gender as fixed effects."||||0.5682
72601177|NCT02688764|144731061|SUPERIORITY|||||||0.2271||||||0.05 level of significance|t-test, 2 sided|||"Age group of \>=6 years to \<12 years~Results are obtained from a linear mixed model which includes change in serum phosphorus levels from baseline to the end of Stage 1 as dependent variable and treatment, baseline serum phosphorus, age (in categories) at randomisation, region (Non-US/US) and gender as fixed effects."||||0.2271
72601178|NCT02688764|144731061|SUPERIORITY|||||||0.022||||||0.05 level of significance|t-test, 2 sided|||"Age group of \>=12 years to \<=18 years~Results are obtained from a linear mixed model which includes change in serum phosphorus levels from baseline to the end of Stage 1 as dependent variable and treatment, baseline serum phosphorus, age (in categories) at randomisation, region (Non-US/US) and gender as fixed effects."||||0.0220
72601179|NCT02688764|144731062|SUPERIORITY|||||||0.0058||||||0.05 level of significance|t-test, 2 sided|||"Group of SP at baseline above Age Related Normal Range~Results are obtained from a linear mixed model which includes change in serum phosphorus levels from baseline to the end of Stage 1 as dependent variable and treatment, baseline serum phosphorus, age (in categories) at randomisation, region (Non-US/US) and gender as fixed effects."||||0.0058
72601180|NCT02688764|144731062|SUPERIORITY|||||||0.5801||||||0.05 level of significance|t-test, 2 sided|||"Group of SP at baseline below or within Age Related Normal Range~Results are obtained from a linear mixed model which includes change in serum phosphorus levels from baseline to the end of Stage 1 as dependent variable and treatment, baseline serum phosphorus, age (in categories) at randomisation, region (Non-US/US) and gender as fixed effects."||||0.5801
72601181|NCT02579382|144731076|SUPERIORITY||Least Squares Mean Difference|0.107||||0.227|TWO_SIDED|95.0|-0.067|0.282||MMRM model included treatment, baseline ALT level, HBeAg baseline status, baseline HBsAg, visit and treatment-by-visit interaction as fixed effect and visit as repeated measurement.|MMRM|||||0.282|-0.067|0.227
72601182|NCT02579382|144731076|SUPERIORITY||Least Squares Mean Difference|0.018||||0.84|TWO_SIDED|95.0|-0.156|0.191||MMRM model included treatment, baseline ALT level, HBeAg baseline status, baseline HBsAg, visit and treatment-by-visit interaction as fixed effect and visit as repeated measurement.|MMRM|||||0.191|-0.156|0.840
72601183|NCT02579382|144731076|SUPERIORITY||Least Squares Mean Difference|0.127||||0.151|TWO_SIDED|95.0|-0.047|0.301||MMRM model included treatment, baseline ALT level, HBeAg baseline status, baseline HBsAg, visit and treatment-by-visit interaction as fixed effect and visit as repeated measurement.|MMRM|||||0.301|-0.047|0.151
72601184|NCT03026283|144731101|OTHER|||||||1||||||In order to evaluate the significance of sensitivity and specificity findings, we implement McNemar's test comparing sensitivity and specificity for CCTA alone and FFR-CT, assuming conditional dependence.|Chi-squared|||Reference test is positive (test of sensitivity).||||1.00
72601185|NCT03026283|144731101|OTHER||||||<|0.0047||||||In order to evaluate the significance of sensitivity and specificity findings, we implement Mcnemar's test comparing sensitive and pscificity for CCTA and FFR-CT assuming dependence.|Chi-squared|McNemar's chi-squared = 8.00||Reference test is Negative||||<0.0047
72601186|NCT03782571|144731108|EQUIVALENCE|Equivalence is concluded if the upper limit is less than 10% and the lower limit is greater than -10%.|Mean Difference (Final Values)|1.7|STANDARD_ERROR_OF_MEAN|1.97|||TWO_SIDED|99.1|-4.0|7.4|||Mixed Models Analysis|Kenward and Roger method was used for denominator degrees of freedom. Adjustment was made using a simulation-based approach.|Test 1 - Control|Testing equivalence with respect to microsphere clearance rate.||7.4|-4.0|
72601187|NCT03782571|144731108|EQUIVALENCE|Equivalence is concluded if the upper limit is less than 10% and the lower limit is greater than -10%.|Mean Difference (Final Values)|4.7|STANDARD_ERROR_OF_MEAN|3.01|||TWO_SIDED|99.1|-4.0|13.4|||Mixed Models Analysis|Kenward and Roger method was used for denominator degrees of freedom. Adjustment was made using a simulation-based approach.|Test 2 - Control|Testing equivalence with respect to microsphere clearance rate.||13.4|-4.0|
72601188|NCT03782571|144731108|EQUIVALENCE|Equivalence is concluded if the upper limit is less than 10% and the lower limit is greater than -10%.|Mean Difference (Final Values)|8.2|STANDARD_ERROR_OF_MEAN|3.78|||TWO_SIDED|99.1|-2.7|19.1|||Mixed Models Analysis|Kenward and Roger method was used for denominator degrees of freedom. Adjustment was made using a simulation-based approach.|Test 3 - Control|Testing equivalence with respect to microsphere clearance rate.||19.1|-2.7|
72601189|NCT03782571|144731108|EQUIVALENCE|Equivalence is concluded if the upper limit is less than 10% and the lower limit is greater than -10%.|Mean Difference (Final Values)|6.5|STANDARD_ERROR_OF_MEAN|3.12|||TWO_SIDED|99.1|-2.6|15.5|||Mixed Models Analysis|Kenward and Roger method was used for denominator degrees of freedom. Adjustment was made using a simulation-based approach.|Test 3 - Test 1|Testing equivalence with respect to microsphere clearance rate.||15.5|-2.6|
72416162|NCT00464815|144343177|NON_INFERIORITY|Criterion for non-inferiority: the lower limit (LL) of the 2-sided standardized asymptotic 95% confidence interval (CI) for the group difference \[Nimenrix Group minus Mencevax ACWY Group\] in the percentage of subjects with bactericidal vaccine response was greater than or equal to (≥) the pre-defined clinical limit of -10%.|Rate difference|15.22|||||TWO_SIDED|95.0|9.89|21.37||||||To demonstrate the non-inferiority of Nimenrix vaccine versus Mencevax ACWY vaccine in term of rSBA-MenY vaccine response, the standardized asymptotic 95% CI for the difference in rSBA vaccine response rate for the meningococcal serogroup Y (Nimenrix Group rate minus Mencevax ACWY Group rate) one month after vaccination was computed.||21.37|9.89|
72416163|NCT00464815|144343178|NON_INFERIORITY|Criterion for non-inferiority: the upper limit (UL) of the 2-sided standardized asymptotic 95% CI for the ratio of the percentages of subjects with any Grade 3 general symptom was lower than or equal to (≤) the pre-defined clinical limit of 3.0.|Risk Ratio (RR)|4.02||||0.1456|TWO_SIDED|95.0|0.68|24.6|||Chi-squared|||To demonstrate the non-inferiority of Nimenrix™ vaccine versus Mencevax™ vaccine in terms of incidence of any Grade 3 general (solicited and unsolicited) symptom, the 2-sided standardised asymptotic 95% CI for the ratio between Nimenrix and Mencevax groups (Nimenrix over Mencevax) in the percentage of subjects with any grade 3 general symptom within 4 days after vaccination was computed for the safety analysis in study MenACWY-TT-036.||24.6|0.68|0.1456
72416164|NCT00000392|144343190|SUPERIORITY_OR_OTHER|||||||0.18|TWO_SIDED||||||ANOVA|||||||0.18
72601190|NCT03782571|144731108|EQUIVALENCE|Equivalence is concluded if the upper limit is less than 10% and the lower limit is greater than -10%.|Mean Difference (Final Values)|3.5|STANDARD_ERROR_OF_MEAN|1.88|||TWO_SIDED|99.1|-2.0|8.9|||Mixed Models Analysis|Kenward and Roger method was used for denominator degrees of freedom. Adjustment was made using a simulation-based approach.|Test 3 - Test 2|Testing equivalence with respect to microsphere clearance rate.||8.9|-2.0|
72601191|NCT03782571|144731108|EQUIVALENCE|Equivalence is concluded if the upper limit is less than 10% and the lower limit is greater than -10%.|Mean Difference (Final Values)|3.0|STANDARD_ERROR_OF_MEAN|2.54|||TWO_SIDED|99.1|-4.3|10.3|||Mixed Models Analysis|Kenward and Roger method was used for denominator degrees of freedom. Adjustment was made using a simulation-based approach.|Test 2 - Test 1|Testing equivalence with respect to microsphere clearance rate.||10.3|-4.3|
72601192|NCT03782571|144731109|EQUIVALENCE|Equivalence is concluded if the upper limit is less than 10% and the lower limit is greater than -10%.|Mean Difference (Final Values)|8.4|STANDARD_ERROR_OF_MEAN|3.24|||TWO_SIDED|99.1|-1.0|17.8|||Mixed Models Analysis|Kenward and Roger method was used for denominator degrees of freedom. Adjustment was made using a simulation-based approach.|Test 1 - Control|Testing equivalence with respect to microsphere uptake rate.||17.8|-1.0|
72601193|NCT03782571|144731109|EQUIVALENCE|Equivalence is concluded if the upper limit is less than 10% and the lower limit is greater than -10%.|Mean Difference (Final Values)|6.6|STANDARD_ERROR_OF_MEAN|4.95|||TWO_SIDED|99.1|-7.8|20.9|||Mixed Models Analysis|Kenward and Roger method was used for denominator degrees of freedom. Adjustment was made using a simulation-based approach.|Test 2 - Control|Testing equivalence with respect to microsphere uptake rate.||20.9|-7.8|
72601194|NCT03782571|144731109|EQUIVALENCE|Equivalence is concluded if the upper limit is less than 10% and the lower limit is greater than -10%.|Mean Difference (Final Values)|2.9|STANDARD_ERROR_OF_MEAN|6.22|||TWO_SIDED|99.1|-15.1|20.9|||Mixed Models Analysis|Kenward and Roger method was used for denominator degrees of freedom. Adjustment was made using a simulation-based approach.|Test 3 - Control|Testing equivalence with respect to microsphere uptake rate.||20.9|-15.1|
72601195|NCT03782571|144731109|EQUIVALENCE|Equivalence is concluded if the upper limit is less than 10% and the lower limit is greater than -10%.|Mean Difference (Final Values)|-5.5|STANDARD_ERROR_OF_MEAN|5.13|||TWO_SIDED|99.1|-20.4|9.4|||Mixed Models Analysis|Kenward and Roger method was used for denominator degrees of freedom. Adjustment was made using a simulation-based approach.|Test 3 - Test 1|Testing equivalence with respect to microsphere uptake rate.||9.4|-20.4|
72601196|NCT03782571|144731109|EQUIVALENCE|Equivalence is concluded if the upper limit is less than 10% and the lower limit is greater than -10%.|Mean Difference (Final Values)|-3.7|STANDARD_ERROR_OF_MEAN|3.1|||TWO_SIDED|99.1|-12.6|5.3|||Mixed Models Analysis|Kenward and Roger method was used for denominator degrees of freedom. Adjustment was made using a simulation-based approach.|Test 3 - Test 2|Testing equivalence with respect to microsphere uptake rate.||5.3|-12.6|
72601197|NCT03782571|144731109|EQUIVALENCE|Equivalence is concluded if the upper limit is less than 10% and the lower limit is greater than -10%.|Mean Difference (Final Values)|-1.8|STANDARD_ERROR_OF_MEAN|4.18|||TWO_SIDED|99.1|-13.9|10.3|||Mixed Models Analysis|Kenward and Roger method was used for denominator degrees of freedom. Adjustment was made using a simulation-based approach.|Test 2 - Test 1|Testing equivalence with respect to microsphere uptake rate.||10.3|-13.9|
72601198|NCT03188523|144731117|SUPERIORITY||Posterior Mean Difference|-1.03|||||||||||||Posterior Probability (PP) of true mean difference in the plasma HIV-1 RNA change from baseline between MK-8504 and placebo at least 0.5 log10 copies/mL was \>98%|Adjusted by Placebo data pooled from historical placebo data from recent monotherapy studies in HIV-1 infected participants (NCT00100048, NCT01466985, NCT01152255, and NCT01353898) and fitted with a longitudinal data analysis (LDA) model containing fixed effects for study and time, and a random effect for participants. LS mean (95% confidence interval) for change from baseline at 168 hours post dose of pooled historical placebo was -0.03 log10 copies/mL (-0.14, 0.09).||||
72601199|NCT03188523|144731117|SUPERIORITY||Posterior Mean Difference|-0.92|||||||||||||Posterior Probability (PP) of true mean difference in the plasma HIV-1 RNA change from baseline between MK-8504 and placebo at least 0.5 log10 copies/mL was \>95%|Adjusted by Placebo data pooled from historical placebo data from recent monotherapy studies in HIV-1 infected participants (NCT00100048, NCT01466985, NCT01152255, and NCT01353898) and fitted with a longitudinal data analysis (LDA) model containing fixed effects for study and time, and a random effect for participants. LS mean (95% confidence interval) for change from baseline at 168 hours post dose of pooled historical placebo was -0.03 log10 copies/mL (-0.14, 0.09).||||
72601200|NCT03188523|144731133|OTHER||Posterior Probability (percentage)|99.0|||||||||||||Posterior Probability (percentage) of true geometric mean (GM) C168hr TFV-DP level in PBMCs ≥0.1 μM|PBMC TFV-DP C168hr values pooled, natural log transformed and analyzed based on a linear model containing a fixed effect for dose level. The posterior probability that the true GM of PBMC TFV-DP C168hr level was ≥0.1 μM was calculated for the dose level using flat priors under a normal likelihood assumption. An 80% posterior probability for a dose level that also exhibits acceptable safety and tolerability would satisfy the secondary PK hypothesis.||||
72601201|NCT03188523|144731133|OTHER||Posterior Probability (percentage)|99.0|||||||||||||Posterior Probability (percentage) of true geometric mean (GM) C168hr TFV-DP level in PBMCs ≥0.1 μM|PBMC TFV-DP C168hr values pooled, natural log transformed and analyzed based on a linear model containing a fixed effect for dose level. The posterior probability that the true GM of PBMC TFV-DP C168hr level was ≥0.1 μM was calculated for the dose level using flat priors under a normal likelihood assumption. An 80% posterior probability for a dose level that also exhibits acceptable safety and tolerability would satisfy the secondary PK hypothesis.||||
72601202|NCT01763203|144731161|SUPERIORITY|||||||0.73|||||||Mixed Models Analysis|||||||0.73
72601203|NCT01763203|144731162|SUPERIORITY|||||||0.77|||||||Mixed Models Analysis|||||||0.77
72601204|NCT01763203|144731164|SUPERIORITY|||||||0.002|||||||Mixed Models Analysis|||||||0.002
72601205|NCT01763203|144731165|SUPERIORITY|||||||0.86|||||||Mixed Models Analysis|||||||0.86
72601206|NCT01763203|144731166|SUPERIORITY|||||||0.1|||||||Mixed Models Analysis|||||||0.10
72601207|NCT01763203|144731167|SUPERIORITY|||||||0.46|||||||Mixed Models Analysis|||||||0.46
72601208|NCT01763203|144731168|SUPERIORITY|||||||0.011|||||||Mixed Models Analysis|||||||0.011
72601209|NCT01763203|144731169|SUPERIORITY|||||||0.47|||||||Mixed Models Analysis|||||||0.47
72601210|NCT01763203|144731170|SUPERIORITY|||||||0.58|||||||Mixed Models Analysis|||||||0.58
72601211|NCT01763203|144731171|SUPERIORITY|||||||0.74|||||||Mixed Models Analysis|||||||0.74
72601212|NCT01763203|144731172|SUPERIORITY|||||||0.0021|||||||Wilcoxon (Mann-Whitney)|||||||0.0021
72601213|NCT01763203|144731173|SUPERIORITY|||||||0.07|||||||Mixed Models Analysis|||||||0.07
72601214|NCT01763203|144731174|SUPERIORITY|||||||0.32|||||||Mixed Models Analysis|||||||0.32
72601215|NCT01763203|144731175|SUPERIORITY|||||||0.77|||||||Chi-squared|||||||0.77
72601216|NCT01763203|144731176|SUPERIORITY|||||||0.2|||||||Mixed Models Analysis|||||||0.20
72601217|NCT01763203|144731177|SUPERIORITY|||||||0.45|||||||t-test, 2 sided|||||||0.45
72601218|NCT01763203|144731178|SUPERIORITY|||||||0.93|||||||t-test, 2 sided|||||||0.93
72601219|NCT01763203|144731179|SUPERIORITY|||||||0.8|||||||t-test, 2 sided|||||||0.80
72601220|NCT01763203|144731180|SUPERIORITY|||||||0.25|||||||t-test, 2 sided|||||||0.25
72601221|NCT02187861|144731181|SUPERIORITY_OR_OTHER||Difference in response rates|3.92|||||TWO_SIDED|95.0|-13.38|21.23||||||||21.23|-13.38|
72601222|NCT02187861|144731182|SUPERIORITY_OR_OTHER||Difference in response rates|1.96|||||TWO_SIDED|95.0|-15.89|19.81||||||||19.81|-15.89|
72601223|NCT02187861|144731183|SUPERIORITY_OR_OTHER||Difference in response rates|1.96|||||TWO_SIDED|95.0|-17.07|20.99||||||||20.99|-17.07|
72601224|NCT02187861|144731184|SUPERIORITY_OR_OTHER||Difference in response rates|-7.84|||||TWO_SIDED|95.0|-27.01|11.32||||||||11.32|-27.01|
72601225|NCT02187861|144731185|SUPERIORITY_OR_OTHER||Difference in response rates|13.73|||||TWO_SIDED|95.0|-4.24|31.69||||||At 6-8 weeks after Cycle 6 Day 1||31.69|-4.24|
72601226|NCT02187861|144731185|SUPERIORITY_OR_OTHER||Difference in response rates|3.92|||||TWO_SIDED|95.0|-12.98|20.82||||||At Year 1||20.82|-12.98|
72601227|NCT02187861|144731186|SUPERIORITY_OR_OTHER||Difference in response rates|-15.69|||||TWO_SIDED|95.0|-31.87|0.49||||||At 4-10 weeks after Cycle 6 Day 1||0.49|-31.87|
72601228|NCT02187861|144731186|SUPERIORITY_OR_OTHER||Difference in response rates|-7.84|||||TWO_SIDED|95.0|-22.56|6.87||||||At Year 1||6.87|-22.56|
72601229|NCT02187861|144731192|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.69|||||TWO_SIDED|95.0|0.38|1.27|||||HR was calculated using Cox regression.|Stratified Analysis: Strata were disease burden and DOR of prior cancer therapy.||1.27|0.38|
72601230|NCT02187861|144731192|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.78|||||TWO_SIDED|95.0|0.43|1.4|||||HR was calculated using Cox regression.|Unstratified Analysis||1.40|0.43|
72601231|NCT02187861|144731194|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.69|||||TWO_SIDED|95.0|0.38|1.24|||||HR was calculated using Cox regression.|Stratified Analysis: Strata were disease burden and PFS of prior cancer therapy.||1.24|0.38|
72601232|NCT02187861|144731194|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.77|||||TWO_SIDED|95.0|0.43|1.36|||||HR was calculated using Cox regression.|Unstratified Analysis||1.36|0.43|
72601233|NCT02187861|144731196|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.69|||||TWO_SIDED|95.0|0.38|1.24|||||HR was calculated using Cox regression.|Stratified Analysis: Strata were disease burden and EFS of prior cancer therapy.||1.24|0.38|
72601234|NCT02187861|144731196|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.77|||||TWO_SIDED|95.0|0.43|1.36|||||HR was calculated using Cox regression.|Unstratified Analysis||1.36|0.43|
72601235|NCT02187861|144731198|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.48|||||TWO_SIDED|95.0|0.04|5.37|||||HR was calculated using Cox regression.|Stratified Analysis: Strata were disease burden and OS of prior cancer therapy.||5.37|0.04|
72601236|NCT02187861|144731198|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.51|||||TWO_SIDED|95.0|0.05|5.63|||||HR was calculated using Cox regression.|Unstratified Analysis||5.63|0.05|
72601237|NCT02020889|144731217|OTHER||Odds Ratio (OR)|5.91|||<|0.001|TWO_SIDED|95.0|2.68|13.03|||Proportional odds regression model|Proportional odds regression model with covariates including treatment group, Baseline prednisolone/prednisone daily dose, Baseline BVAS score, region|Mepolizumab 300mg/Placebo|||13.03|2.68|<0.001
72601238|NCT02020889|144731218|OTHER||Odds Ratio (OR)|16.74|||<|0.001|TWO_SIDED|95.0|3.61|77.56|||Regression, Logistic|Logistic regression model with covariates including treatment group, Baseline prednisolone/prednisone daily dose, Baseline BVAS score and region|Mepolizumab 300mg/Placebo|||77.56|3.61|<0.001
72601239|NCT02020889|144731219|OTHER||Hazard Ratio (HR)|0.322|||<|0.001|TWO_SIDED|95.0|0.206|0.502|||Cox Proportional Hazard regression|Cox proportional hazards model with covariates of treatment group, Baseline prednisolone/prednisone daily dose, Baseline BVAS score and region|Mepolizumab 300mg/Placebo|||0.502|0.206|<0.001
72601240|NCT02020889|144731220|OTHER||Odds Ratio (OR)|0.2|||<|0.001|TWO_SIDED|95.0|0.09|0.41|||Proportional odds regression model|Proportional odds regression model with covariates including treatment group, Baseline prednisolone/prednisone daily dose, Baseline BVAS score, region|Mepolizumab 300mg/Placebo|||0.41|0.09|<0.001
72601241|NCT02020889|144731221|OTHER||Odds Ratio (OR)|19.65||||0.007|TWO_SIDED|95.0|2.3|167.93|||Regression, Logistic|Logistic regression model with covariates including treatment group, Baseline prednisolone/prednisone daily dose, Baseline BVAS score and region|Mepolizumab 300mg/Placebo|||167.93|2.30|0.007
72601242|NCT02020889|144731222|OTHER||Odds Ratio (OR)|5.31|||<|0.001|TWO_SIDED|95.0|2.63|10.74|||Proportional odds regression model|Proportional odds regression model with covariates including treatment group, Baseline prednisolone/prednisone daily dose, Baseline BVAS score, region|Mepolizumab 300mg/Placebo|||10.74|2.63|<0.001
72601243|NCT02020889|144731223|OTHER||Odds Ratio (OR)|7.19|||<|0.001|TWO_SIDED|95.0|2.6|19.87|||Regression, Logistic|Logistic regression model with covariates including treatment group, Baseline prednisolone/prednisone daily dose, Baseline BVAS score and region|Mepolizumab 300mg/Placebo|||19.87|2.60|<0.001
72601244|NCT02020889|144731224|OTHER||Odds Ratio (OR)|11.39||||0.003|TWO_SIDED|95.0|2.35|55.24|||Regression, Logistic|Logistic regression model with covariates including treatment group, Baseline prednisolone/prednisone daily dose, Baseline BVAS score and region.|Mepolizumab 300mg/Placebo|||55.24|2.35|0.003
72601245|NCT03224624|144731256|EQUIVALENCE|Comparing baseline-\>12month SBP change (mean difference) between the two groups.|Mean Difference (Net)|-1.35|STANDARD_ERROR_OF_MEAN|3.8||0.72|TWO_SIDED|||||p\<0.05 considered significant.|t-test, 2 sided||direction of comparison: (self-management change over 12 months) - (usual care change over 12 months) in SBP|t- tests were done to compare group mean differences between self-management and usual care and within groups Mean differences were calculated by subtracting 12-month blood pressure from baseline blood pressure for each participant. t-tests were done to compare mean differences between the two groups.||||0.72
72601246|NCT03224624|144731256|EQUIVALENCE|Comparing baseline-\>12month DBP change (mean difference) between the two groups.|Mean Difference (Net)|-3.75|STANDARD_ERROR_OF_MEAN|2.55||0.15|TWO_SIDED||||||t-test, 2 sided||direction of comparison: (self-management change over 12 months) - (usual care change over 12 months) in DBP|Mean differences were calculated by subtracting 12-month blood pressure from baseline blood pressure for each participant. t-tests were done to compare mean differences between the two groups.||||0.15
72601247|NCT03224624|144731256|EQUIVALENCE|Comparing baseline-\>12month SBP change within self-management group (null hypothesis no change).|Mean Difference (Net)|-6.95||||0.01|TWO_SIDED||||||t-test, 2 sided||(12-month SBP)-(baseline SBP) for self-management group (as given in table)|change in SBP from baseline to 12-months within self-management group.||||0.01
72601248|NCT03224624|144731256|EQUIVALENCE|Comparing baseline-\>12month SBP change within usual care group (null hypothesis no change).|Mean Difference (Net)|-5.59|||<|0.05|TWO_SIDED||||||t-test, 2 sided||(12-month SBP)-(baseline SBP) for usual care group (as given in table)|Comparing baseline-\>12month SBP change within usual care group.||||<0.05
72601249|NCT03224624|144731256|EQUIVALENCE|Comparing baseline-\>12month DBP change within self-management group (null hypothesis no change).|Mean Difference (Net)|-5.51|||<|0.01|TWO_SIDED||||||t-test, 2 sided||(12-month DBP)-(baseline DBP) for self-management group (as given in table)|change in DBP from baseline to 12-months within self-management group.||||<0.01
72601250|NCT03224624|144731256|EQUIVALENCE|change in DBP from baseline to 12-months within usual care group.|Mean Difference (Net)|-1.76||||0.34|TWO_SIDED||||||t-test, 2 sided||(12-month DBP)-(baseline DBP) for usual care group (as given in table)|||||0.34
72601251|NCT01884545|144731259|SUPERIORITY|||||||0.1073|||||||Regression, Linear|||||||0.1073
72601252|NCT01884545|144731259|SUPERIORITY|||||||0.0615|||||||Regression, Linear|||||||0.0615
72601253|NCT01884545|144731260|SUPERIORITY|||||||0.6732|||||||Regression, Linear|||||||0.6732
72601254|NCT01884545|144731260|SUPERIORITY|||||||0.3754|||||||Regression, Linear|||||||0.3754
72601255|NCT01884545|144731261|SUPERIORITY||Odds Ratio (OR)|2.853||||0.0073|TWO_SIDED|95.0|1.326|6.139|||Regression, Logistic|||||6.139|1.326|0.0073
72601256|NCT01884545|144731261|SUPERIORITY||Odds Ratio (OR)|1.045||||0.9068|TWO_SIDED|95.0|0.5|2.183|||Regression, Logistic|||||2.183|0.5|0.9068
72601257|NCT01884545|144731262|SUPERIORITY||Odds Ratio (OR)|1.333||||0.7822|TWO_SIDED|95.0|0.173|10.254|||Regression, Logistic|||||10.254|0.173|0.7822
72416165|NCT04402866|144343192|OTHER||Common Odds Ratio|1.142||||0.6137|TWO_SIDED|95.0|0.706|1.846|||Van Elteren test||Common Odds Ratio (TD-0903 vs. placebo) and corresponding 95% Wald confidence interval (CI) were obtained from the proportional odds regression model of RFD adjusting for baseline age strata (≤ 60 years vs. \> 60 years).|Since this was a Phase 2 study, it was not powered for any of the secondary endpoints.||1.846|0.706|0.6137
72601258|NCT01884545|144731262|SUPERIORITY||Odds Ratio (OR)|1.333||||0.7822|TWO_SIDED|95.0|0.173|10.254|||Regression, Logistic|||||10.254|0.173|0.7822
72601259|NCT01884545|144731263|SUPERIORITY|||||||0.7985|||||||Regression, Linear|||||||0.7985
72601260|NCT01884545|144731263|SUPERIORITY|||||||0.1642|||||||Regression, Linear|||||||0.1642
72601261|NCT01884545|144731264|SUPERIORITY|||||||0.8027|||||||Regression, Linear|||||||0.8027
72601262|NCT01884545|144731264|SUPERIORITY|||||||0.7751|||||||Regression, Linear|||||||0.7751
72601263|NCT01884545|144731265|SUPERIORITY|||||||0.5557|||||||Regression, Linear|||||||0.5557
72601264|NCT01884545|144731265|SUPERIORITY|||||||0.7834|||||||Regression, Linear|||||||0.7834
72601265|NCT01884545|144731266|SUPERIORITY|||||||0.1439|||||||Regression, Linear|||||||0.1439
72601266|NCT01884545|144731266|SUPERIORITY|||||||0.2275|||||||Regression, Linear|||||||0.2275
72601267|NCT01884545|144731267|SUPERIORITY|||||||0.7639|||||||Regression, Linear|||||||0.7639
72601268|NCT01884545|144731267|SUPERIORITY|||||||0.9999|||||||Regression, Linear|||||||0.9999
72601269|NCT01884545|144731268|SUPERIORITY|||||||0.4673|||||||Regression, Linear|||||||0.4673
72601270|NCT01884545|144731268|SUPERIORITY|||||||0.2297|||||||Regression, Linear|||||||0.2297
72601271|NCT01884545|144731269|SUPERIORITY|||||||0.2192|||||||Regression, Linear|||||||0.2192
72601272|NCT01884545|144731269|SUPERIORITY|||||||0.9062|||||||Regression, Linear|||||||0.9062
72601273|NCT01884545|144731270|SUPERIORITY|||||||0.1466|||||||Regression, Linear|||||||0.1466
72601274|NCT01884545|144731270|SUPERIORITY|||||||0.207|||||||Regression, Linear|||||||0.2070
72601275|NCT01884545|144731271|SUPERIORITY|||||||0.6289|||||||Regression, Linear|||||||0.6289
72601276|NCT01884545|144731271|SUPERIORITY|||||||0.9631|||||||Regression, Linear|||||||0.9631
72601277|NCT01884545|144731272|SUPERIORITY|||||||0.2313|||||||Regression, Linear|||||||0.2313
72601278|NCT01884545|144731272|SUPERIORITY|||||||0.8029|||||||Regression, Linear|||||||0.8029
72601279|NCT01884545|144731273|SUPERIORITY|||||||0.071|||||||Regression, Linear|||||||0.0710
72601280|NCT01884545|144731273|SUPERIORITY|||||||0.8069|||||||Regression, Linear|||||||0.8069
72601281|NCT01884545|144731274|SUPERIORITY|||||||0.0512|||||||Chi-squared|||||||0.0512
72601282|NCT01884545|144731274|SUPERIORITY|||||||0.4478|||||||Chi-squared|||||||0.4478
72601283|NCT01884545|144731277|SUPERIORITY|||||||0.7923|||||||Regression, Linear|||Perceived Risk for CHD, Consequences subscale||||0.7923
72601284|NCT01884545|144731277|SUPERIORITY|||||||0.0636|||||||Regression, Linear|||Perceived Risk for CHD, Personal control||||0.0636
72601285|NCT01884545|144731277|SUPERIORITY|||||||0.2063|||||||Regression, Linear|||Perceived Risk for CHD, Treatment control||||0.2063
72601286|NCT01884545|144731277|SUPERIORITY|||||||0.2529|||||||Regression, Linear|||Perceived Risk for CHD, Emotional representations||||0.2529
72601287|NCT01884545|144731277|SUPERIORITY|||||||0.1085|||||||Regression, Linear|||Perceived Risk for coronary heart disease (CHD), Consequences subscale||||0.1085
72601288|NCT01884545|144731277|SUPERIORITY|||||||0.337|||||||Regression, Linear|||Perceived Risk for coronary heart disease (CHD), personal control subscale||||0.3370
72601289|NCT01884545|144731277|SUPERIORITY|||||||0.3483|||||||Regression, Linear|||Perceived Risk for coronary heart disease (CHD), treatment control subscale||||0.3483
72601290|NCT01884545|144731277|SUPERIORITY|||||||0.5384|||||||Regression, Linear|||Perceived Risk for coronary heart disease (CHD), emotional representations||||0.5384
72601291|NCT01884545|144731278|SUPERIORITY|||||||0.7447|||||||Regression, Linear|||Perceived Risk for T2D, Consequences subscale||||0.7447
72601292|NCT01884545|144731278|SUPERIORITY|||||||0.6378|||||||Regression, Linear|||Perceived Risk for T2D, Personal control||||0.6378
72601293|NCT01884545|144731278|SUPERIORITY|||||||0.3209|||||||Regression, Linear|||Perceived Risk for T2D, Treatment control||||0.3209
72601294|NCT01884545|144731278|SUPERIORITY|||||||0.0058|||||||Regression, Linear|||Perceived Risk for T2D, Emotional representations||||0.0058
72601295|NCT01884545|144731278|SUPERIORITY|||||||0.3769|||||||Regression, Linear|||Perceived Risk for type 2 diabetes (T2D), Consequences subscale||||0.3769
72601296|NCT01884545|144731278|SUPERIORITY|||||||0.0872|||||||Regression, Linear|||Perceived Risk for type 2 diabetes (T2D), personal control||||0.0872
72601297|NCT01884545|144731278|SUPERIORITY|||||||0.4302|||||||Regression, Linear|||Perceived Risk for type 2 diabetes (T2D), treatment control||||0.4302
72601298|NCT01884545|144731278|SUPERIORITY|||||||0.4133|||||||Regression, Linear|||Perceived Risk for type 2 diabetes (T2D), emotional representations||||0.4133
72601299|NCT01884545|144731279|SUPERIORITY|||||||0.3106|||||||Regression, Linear|||||||0.3106
72601300|NCT01884545|144731279|SUPERIORITY|||||||0.7087|||||||Regression, Linear|||||||0.7087
72416166|NCT04402866|144343193|OTHER|Since this was a Phase 2 study, it was not powered for any of the secondary endpoints.|LS mean difference|-0.51||||0.962|TWO_SIDED|95.0|-21.95|20.92|||Mixed model repeated measures model|||Part 2: TD-0903 - Parallel-Group 3 mg versus Part 2: Matching Placebo - Parallel-Group||20.92|-21.95|0.962
72601301|NCT01884545|144731280|SUPERIORITY||Odds Ratio (OR)|1.034||||0.9259|TWO_SIDED|95.0|0.511|2.094|||Regression, Logistic|||Stages of Change, Weight reduction||2.094|0.511|0.9259
72601302|NCT01884545|144731280|SUPERIORITY||Odds Ratio (OR)|2.252||||0.0082|TWO_SIDED|95.0|1.234|4.111|||Regression, Logistic|||Stages of Change, Exercise behavior||4.111|1.234|0.0082
72601303|NCT01884545|144731280|SUPERIORITY||Odds Ratio (OR)|0.423||||0.2954|TWO_SIDED|95.0|0.084|2.12|||Regression, Logistic|||Stages of Change, Smoking behavior||2.120|0.084|0.2954
72601304|NCT01884545|144731280|SUPERIORITY||Odds Ratio (OR)|1.216||||0.5669|TWO_SIDED|95.0|0.622|2.376|||Regression, Logistic|||Stages of Change, Healthier eating behavior||2.376|0.622|0.5669
72601305|NCT01884545|144731280|SUPERIORITY||Odds Ratio (OR)|0.622||||0.121|TWO_SIDED|95.0|0.341|1.134|||Regression, Logistic|||Stages of Change, Stress behavior||1.134|0.341|0.1210
72601306|NCT01884545|144731280|SUPERIORITY||Odds Ratio (OR)|0.928||||0.8355|TWO_SIDED|95.0|0.461|1.872|||Regression, Logistic|||Weight reduction||1.872|0.461|0.8355
72601307|NCT01884545|144731280|SUPERIORITY||Odds Ratio (OR)|1.83||||0.0459|TWO_SIDED|95.0|1.011|3.311|||Regression, Logistic|||Exercise behavior||3.311|1.011|0.0459
72601308|NCT01884545|144731280|SUPERIORITY||Odds Ratio (OR)|0.563||||0.465|TWO_SIDED|95.0|0.121|2.629|||Regression, Logistic|||Smoking behavior||2.629|0.121|0.4650
72601309|NCT01884545|144731280|SUPERIORITY||Odds Ratio (OR)|0.93||||0.8303|TWO_SIDED|95.0|0.478|1.808|||Regression, Logistic|||Healthier eating behavior||1.808|0.478|0.8303
72601310|NCT01884545|144731280|SUPERIORITY||Odds Ratio (OR)|1.347||||0.3254|TWO_SIDED|95.0|0.744|2.439|||Regression, Logistic|||Stress behavior||2.439|0.744|0.3254
72601311|NCT01884545|144731281|SUPERIORITY|||||||0.0174|||||||Regression, Linear|||||||0.0174
72601312|NCT01884545|144731281|SUPERIORITY|||||||0.8694|||||||Regression, Linear|||||||0.8694
72601313|NCT01884545|144731282|SUPERIORITY|||||||0.4768|||||||Regression, Linear|||||||0.4768
72601314|NCT01884545|144731282|SUPERIORITY|||||||0.8452|||||||Regression, Linear|||||||0.8452
72601315|NCT01884545|144731283|SUPERIORITY||Odds Ratio (OR)|1.591||||0.5589|TWO_SIDED|95.0|0.335|7.544|||Regression, Logistic|||||7.544|0.335|0.5589
72601316|NCT00351936|144731316|SUPERIORITY_OR_OTHER|||||||0.003||95.0|||||ANCOVA|||||||0.003
72601317|NCT00351936|144731317|SUPERIORITY_OR_OTHER|||||||0.003||95.0|||||ANCOVA|||||||0.003
72601318|NCT00351936|144731318|SUPERIORITY_OR_OTHER|||||||0.747||95.0|||||ANCOVA|||||||0.747
72601319|NCT00351936|144731319|SUPERIORITY_OR_OTHER|||||||0.208||95.0|||||ANCOVA|||||||0.208
72601320|NCT00351936|144731320|SUPERIORITY_OR_OTHER|||||||0.665||95.0|||||ANCOVA|||||||0.665
72601321|NCT00351936|144731321|SUPERIORITY_OR_OTHER|||||||0.999||95.0|||||ANCOVA|||||||0.999
72601322|NCT00351936|144731322|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||ANCOVA|||||||0.001
72601323|NCT02937636|144731323|OTHER||Least square (LS) mean difference|-0.09|||<|0.0001|TWO_SIDED|95.0|-0.12|-0.07|||ANCOVA|From ANCOVA with treatment, gender, smoking status and baseline MGI stratification as factors and baseline as covariate.|Difference is the first named treatment minus second named treatment such that a negative difference favors the first named treatment.|||-0.07|-0.12|<.0001
72601324|NCT00583011|144731335|EQUIVALENCE||Median Difference (Final Values)|0.02|||<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<0.05
72601325|NCT03681184|144731395|SUPERIORITY||Difference in Least Squares (LS) Mean|-53.546|STANDARD_ERROR_OF_MEAN|4.3224|<|0.0001|TWO_SIDED|95.0|-62.314|-44.778||P=1.685E-14|MMRM|||The Mixed-Effect Model Repeated Measures (MMRM) includes fixed effects of treatment arms (lumasiran vs. placebo) and scheduled visits (months 3, 4, 5, and 6), baseline 24-hour urinary oxalate corrected for BSA as a continuous fixed covariate, and patient as a random effect. The variance-covariance matrix is assumed to be unstructured. Satterthwaite approximation is used to estimate denominator degrees of freedom.||-44.778|-62.314|<0.0001
72601326|NCT03681184|144731396|SUPERIORITY||Difference in LS Mean|-0.975|STANDARD_ERROR_OF_MEAN|0.0998|<|0.0001|TWO_SIDED|95.0|-1.177|-0.772||P=1.225E-11|MMRM|||The MMRM includes fixed effects of treatment arms (lumasiran vs. placebo) and scheduled visits (months 3, 4, 5, and 6), baseline 24-hour urinary oxalate corrected for BSA as a continuous fixed covariate, and patient as a random effect. The variance-covariance matrix is assumed to be unstructured. Satterthwaite approximation is used to estimate denominator degrees of freedom.||-0.772|-1.177|<0.0001
72601327|NCT03681184|144731397|SUPERIORITY||Difference in LS Mean|-51.7718|STANDARD_ERROR_OF_MEAN|6.16118|<|0.0001|TWO_SIDED|95.0|-64.2653|-39.2784||P=5.032E-10|MMRM|||The MMRM includes fixed effects of treatment arms (lumasiran vs. placebo) and scheduled visits (months 3, 4, 5, and 6), baseline 24-hour urinary oxalate:creatinine ratio as a continuous fixed covariate, and patient as a random effect. The variance-covariance matrix is assumed to be unstructured. Satterthwaite approximation is used to estimate denominator degrees of freedom.||-39.2784|-64.2653|<0.0001
72601328|NCT03681184|144731398|SUPERIORITY||Difference in Proportions|0.84|||<|0.0001|TWO_SIDED|95.0|0.55|0.94||P=8.341E-07|Cochran-Mantel-Haenszel|||The proportion of participants (lumasiran vs. placebo) with 24-hour urinary oxalate ≤1.5 x ULN at Month 6 is analyzed using the Cochran-Mantel-Haenszel test, stratified by baseline 24-hour urinary oxalate corrected for BSA (≤1.70 mmol/24hr/1.73m\^2 vs. \>1.70 mmol/24hr/1.73m\^2). The difference in proportion (lumasiran vs. placebo) and the corresponding 95% confidence interval are calculated using the Newcombe method, based on the Wilson score.||0.94|0.55|<0.0001
72601329|NCT03681184|144731399|SUPERIORITY||Difference in Proportions|0.52||||0.001|TWO_SIDED|95.0|0.23|0.7|||Cochran-Mantel-Haenszel|||The proportion of participants (lumasiran vs. placebo) with 24-hour urinary oxalate ≤ULN at Month 6 is analyzed using the Cochran-Mantel-Haenszel test, stratified by baseline 24-hour urinary oxalate corrected for BSA (≤1.70 mmol/24hr/1.73m\^2 vs. \>1.70 mmol/24hr/1.73m\^2). The difference in proportion (lumasiran vs. placebo) and the corresponding 95% confidence interval are calculated using the Newcombe method, based on the Wilson score.||0.70|0.23|0.0010
72601330|NCT03681184|144731400|SUPERIORITY||Difference in LS Mean|-39.48|STANDARD_ERROR_OF_MEAN|5.181|<|0.0001|TWO_SIDED|95.0|-50.1|-28.87||P=2.862E-08|MMRM|||The MMRM includes fixed effects of treatment arms (lumasiran vs. placebo) and scheduled visits (months 3, 4, 5, and 6), baseline plasma oxalate as a continuous fixed covariate, and patient as a random effect. The variance-covariance matrix is assumed to be unstructured. Satterthwaite approximation is used to estimate denominator degrees of freedom.||-28.87|-50.10|<0.0001
72601331|NCT03681184|144731401|SUPERIORITY||Difference in LS Mean|-8.71|STANDARD_ERROR_OF_MEAN|1.338|<|0.0001|TWO_SIDED|95.0|-11.45|-5.98||P=3.893E-07|MMRM|||The MMRM includes fixed effects of treatment arms (lumasiran vs. placebo) and scheduled visits (months 3, 4, 5, and 6), baseline plasma oxalate as a continuous fixed covariate, and patient as a random effect. The variance-covariance matrix is assumed to be unstructured. Satterthwaite approximation is used to estimate denominator degrees of freedom.||-5.98|-11.45|<0.0001
72601332|NCT04424914|144731435|OTHER|||||||0.3006|||||||Chi-squared|p-values for comparison of proportions of CLASS I+II vs CLASS III+IV were based on a Chi-square test.||||||0.3006
72601333|NCT04424914|144731436|OTHER||||||<|0.0001|||||||Wilcoxon rank sum test|||||||<0.0001
72601334|NCT04485637|144731437|SUPERIORITY||Odds Ratio (OR)|1.67|||=|0.05|TWO_SIDED|95.0|1.0|2.79|||Regression, Logistic|Adjusted for respondent characteristics as described in statistical analysis plan.||Enhanced table \> Basic table||2.79|1.00|=0.05
72601335|NCT04485637|144731437|SUPERIORITY||Odds Ratio (OR)|1.66|||=|0.05|TWO_SIDED|95.0|1.0|2.76|||Regression, Logistic|Adjusted for respondent characteristics as described in statistical analysis plan.||Enhanced graph \> Basic table||2.76|1.00|=0.05
72601336|NCT04485637|144731438|SUPERIORITY|Enhanced table \> Basic table|Odds Ratio (OR)|1.52|||=|0.29|TWO_SIDED|95.0|0.71|3.26|||Regression, Logistic|Adjusted for respondent characteristics as described in statistical analysis plan.||||3.26|0.71|=0.29
72601337|NCT04485637|144731438|SUPERIORITY|Enhanced graph \> Basic table|Odds Ratio (OR)|0.96|||=|0.9|TWO_SIDED|95.0|0.48|1.93|||Regression, Logistic|Adjusted for respondent characteristics as described in statistical analysis plan.||||1.93|0.48|=0.90
72601338|NCT04485637|144731439|SUPERIORITY||Unst|-0.14|||=|0.13|TWO_SIDED|95.0|-0.32|0.04|||Regression, Linear|Adjusted for respondent characteristics as described in statistical analysis plan.||Enhanced table \> Basic table||0.04|-0.32|=0.13
72601339|NCT04485637|144731439|SUPERIORITY||Unstandardized B|-0.14|||=|0.12|TWO_SIDED|95.0|-0.32|0.04|||Regression, Linear|Adjusted for respondent characteristics as described in statistical analysis plan.||Enhanced graph \> Basic table||0.04|-0.32|=0.12
72601340|NCT04485637|144731440|SUPERIORITY|Enhanced table \> Basic table|Unstandardized B|-0.08|||=|0.33|TWO_SIDED|95.0|-0.25|0.08|||Regression, Linear|||||0.08|-0.25|=0.33
72601341|NCT04485637|144731440|SUPERIORITY||Unstandardized B|-0.09|||=|0.29|TWO_SIDED|95.0|-0.26|0.08|||Regression, Linear|Adjusted for respondent characteristics as described in statistical analysis plan.||||0.08|-0.26|=0.29
72601342|NCT02453256|144731486|SUPERIORITY||Difference in least square means|-1.73||||0.0983|TWO_SIDED|95.0|-3.78|0.32|||Repeated Measure|||Difference in least square means between the TCZ group and the Placebo group at week 48. Null hypothesis: There is no difference between the TCZ group and the placebo group in mean change in mRSS from baseline to Week 48.||0.32|-3.78|0.0983
72601343|NCT02453256|144731487|SUPERIORITY||Weighted difference|21.91||||0.0007|TWO_SIDED|95.0|9.2|34.6|||Cochran-Mantel-Haenszel|||This statistical analysis applies to participants with ≥ 20% improvement in mRSS.||34.6|9.2|0.0007
72601344|NCT02453256|144731487|SUPERIORITY||Weighted difference|4.32||||0.5139|TWO_SIDED|95.0|-8.7|17.3|||Cochran-Mantel-Haenszel|||This statistical analysis applies to participants with ≥ 40% improvement in mRSS.||17.3|-8.7|0.5139
72601345|NCT02453256|144731487|SUPERIORITY||Weighted difference|-5.41||||0.3276|TWO_SIDED|95.0|-16.2|5.4|||Cochran-Mantel-Haenszel|||This statistical analysis applies to participants with ≥ 60% improvement in mRSS.||5.4|-16.2|0.3276
72601346|NCT02453256|144731488|SUPERIORITY|||||||0.0015||||||P-value from Van Elteren analysis stratified by IL-6 level (\<10; \>=10 pg/mL) at screening.|Van Elteren|||||||0.0015
72601347|NCT02453256|144731489|SUPERIORITY||Difference in least square means|0.167||||0.0001|TWO_SIDED|95.0|0.083|0.25|||Repeated Measure|||||0.250|0.083|0.0001
72601348|NCT02453256|144731490|SUPERIORITY||Difference in least square means|-0.053||||0.4489|TWO_SIDED|95.0|-0.192|0.085|||Repeated Measure|||||0.085|-0.192|0.4489
72601349|NCT02453256|144731491|SUPERIORITY||Difference in least square means|-2.44||||0.4339|TWO_SIDED|95.0|-8.57|3.7|||Repeated Measure|||||3.70|-8.57|0.4339
72601350|NCT02453256|144731492|SUPERIORITY||Difference in least square means|-2.46||||0.4378|TWO_SIDED|95.0|-8.72|3.79|||Repeated Measure|||||3.79|-8.72|0.4378
72601351|NCT02453256|144731493|SUPERIORITY||Hazard Ratio (HR)|0.63||||0.0821|TWO_SIDED|95.0|0.37|1.06|||Cox-proportional hazards model|||||1.06|0.37|0.0821
72601352|NCT01237327|144731547|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.7799||||0.3348|TWO_SIDED|95.0|0.47|1.294|||Log Rank|||Overall survival compared using the hazard ratio; hazard ratio \<1.0 is in favor of exemestane.||1.294|0.47|0.3348
72601353|NCT05052697|144731612|OTHER||Geometric Mean Ratio|0.86|||||TWO_SIDED|95.0|0.34|2.2|||||GMRs and the corresponding 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the difference (qIRV group minus QIV group) and the corresponding CIs (based on the Student t distribution).|Strain: A1||2.20|0.34|
72601354|NCT05052697|144731612|OTHER||Geometric Mean Ratio|1.53|||||TWO_SIDED|95.0|0.86|2.7|||||GMRs and the corresponding 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the difference (qIRV group minus QIV group) and the corresponding CIs (based on the Student t distribution).|Strain: A2||2.70|0.86|
72601355|NCT05052697|144731612|OTHER||Geometric Mean Ratio|0.96|||||TWO_SIDED|95.0|0.4|2.28|||||GMRs and the corresponding 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the difference (qIRV group minus QIV group) and the corresponding CIs (based on the Student t distribution).|Strain: B1||2.28|0.40|
72416167|NCT04402866|144343194|OTHER|Since this was a Phase 2 study, it was not powered for any of the secondary endpoints.|Odds Ratio (OR)|1.153||||0.5918|TWO_SIDED|95.0|0.692|1.922|||Van Elteren test||Between-group comparisons analyzed using a proportional odds model adjusting for baseline age strata (≤ 60 years vs. \> 60 years).|Part 2: TD-0903 - Parallel-Group 3 mg versus Part 2: Matching Placebo - Parallel-Group on Day 7||1.922|0.692|0.5918
72416168|NCT04402866|144343194|OTHER|Since this was a Phase 2 study, it was not powered for any of the secondary endpoints.|Odds Ratio (OR)|1.105||||0.6978|TWO_SIDED|95.0|0.651|1.878|||Van Elteren test|||Part 2: TD-0903 - Parallel-Group 3 mg versus Part 2: Matching Placebo - Parallel-Group on Day 14|Between-group comparisons analyzed using a proportional odds model adjusting for baseline age strata (≤ 60 years vs. \> 60 years).|1.878|0.651|0.6978
72601356|NCT05052697|144731612|OTHER||Geometric Mean Ratio|0.54|||||TWO_SIDED|95.0|0.25|1.18|||||GMRs and the corresponding 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the difference (qIRV group minus QIV group) and the corresponding CIs (based on the Student t distribution).|Strain: B2||1.18|0.25|
72601357|NCT05052697|144731613|OTHER||Difference in percentage of participants|26.2|||||TWO_SIDED|95.0|-4.5|53.5|||||Difference in percentage of participants achieving seroconversion, qIRV group - Licensed QIV group as reference, expressed as a percentage.|Strain: A1||53.5|-4.5|
72601358|NCT05052697|144731613|OTHER||Difference in percentage of participants|17.1|||||TWO_SIDED|95.0|-19.2|49.4|||||Difference in percentage of participants achieving seroconversion, qIRV group - Licensed QIV group as reference, expressed as a percentage.|Strain: A2||49.4|-19.2|
72601359|NCT05052697|144731613|OTHER||Difference in percentage of participants|-12.4|||||TWO_SIDED|95.0|-41.7|19.1|||||Difference in percentage of participants achieving seroconversion, qIRV group - Licensed QIV group as reference, expressed as a percentage.|Strain: B1||19.1|-41.7|
72601360|NCT05052697|144731613|OTHER||Difference in percentage of participants|1.4|||||TWO_SIDED|95.0|-29.2|32.5|||||Difference in percentage of participants achieving seroconversion, qIRV group - Licensed QIV group as reference, expressed as a percentage.|Strain: B2||32.5|-29.2|
72601361|NCT01289574|144731632|SUPERIORITY_OR_OTHER|||||||0.1919|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) row mean score statistics, adjusting for investigational site||||||0.1919
72601362|NCT01289574|144731633|SUPERIORITY_OR_OTHER|||||||0.061|||||||Cochran-Mantel-Haenszel|||||||0.0610
72601363|NCT01289574|144731634|SUPERIORITY_OR_OTHER|||||||0.0857|||||||Cochran-Mantel-Haenszel|||||||0.0857
72601364|NCT01554163|144731658|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Etoricoxib 30 mg will be considered non-inferior to celecoxib 200 mg if the upper bound of the two-sided 95% confidence interval of the betweentreatment difference in LS mean time-weighted average change from baseline over 12 weeks in WOMAC Pain Subscale (VAS) is no greater than 10 mm (non-inferiority margin).|Difference in LS Mean Change|-1.63||||0.39|TWO_SIDED|95.0|-5.37|2.1|||ANCOVA|||||2.10|-5.37|0.390
72601365|NCT01554163|144731659|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Etoricoxib 30 mg will be considered non-inferior to celecoxib 200 mg if the upper bound of the two-sided 95% confidence interval of the between-treatment difference in LS means (etoricoxib minus celecoxib) is no greater than 10 mm.|Difference in LS Mean Change|-1.32||||0.464|TWO_SIDED|95.0|-4.88|2.23|||ANCOVA|||||2.23|-4.88|0.464
72601366|NCT01554163|144731660|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Etoricoxib 30 mg will be considered non-inferior to celecoxib 200 mg if the upper bound of the two-sided 95% confidence interval of the between-treatment difference in LS means (etoricoxib minus celecoxib) is no greater than 10 mm.|Difference in LS Mean Change|-1.09||||0.624|TWO_SIDED|95.0|-5.48|3.3|||ANCOVA|||||3.30|-5.48|0.624
72601367|NCT01554163|144731661|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Mean Change|-0.08||||0.369|TWO_SIDED|95.0|-0.26|0.1|||ANCOVA|||||0.10|-0.26|0.369
72601368|NCT01554163|144731662|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Mean Change|-0.09||||0.294|TWO_SIDED|95.0|-0.25|0.08|||ANCOVA|||||0.08|-0.25|0.294
72601369|NCT01554163|144731663|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Mean Change|-0.86||||0.679|TWO_SIDED|95.0|-4.96|3.24|||ANCOVA|||||3.24|-4.96|0.679
72601370|NCT01554163|144731664|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Mean Change|-0.1||||0.314|TWO_SIDED|95.0|-0.3|0.1|||ANCOVA|||||0.10|-0.30|0.314
72601371|NCT01037816|144731672|SUPERIORITY|||||||0.137|||||||ANCOVA|||The treatment effect of the FS-67 patch was estimated by computing the difference in LS means of the FS-67 and placebo patches from the ANCOVA model||||0.137
72601372|NCT01037816|144731673|SUPERIORITY|||||||0.044|||||||ANCOVA|||||||0.044
72601373|NCT01972464|144731678|SUPERIORITY||Odds Ratio (OR)|1.77||||0.39|TWO_SIDED|95.0|0.48|6.52||a priori threshold for statistical significance = 0.05|Regression, Logistic|adjusted for age (18-25 years versus \>25 years) and pre-quit smoking level (\<10 versus \>10 cigarettes per day)|OR represents of odds of abstinence in progesterone group versus placebo group|Null hypothesis- odds of week 8 point prevalence abstinence were equal between placebo and progesterone group.||6.52|0.48|0.39
72601374|NCT01972464|144731679|SUPERIORITY||Hazard Ratio (HR)|1.39||||0.41|TWO_SIDED|95.0|0.66|3.38||a priori threshold = 0.05|Regression, Cox|Adjusted for age and pre-quit smoking level|Hazard ratio is placebo / progesterone|||3.38|0.66|0.41
72601375|NCT01972464|144731680|SUPERIORITY||Risk Ratio (RR)|0.91|||<|0.001|TWO_SIDED|95.0|0.86|0.96|||general estimating equation|adjusted for age \& pre-quit smoking level; specified a gamma distribution, log link, autoregressive correlation structure|risk ratio is progesterone versus placebo|null hypothesis rate of change in QSU-brief scores were equal between treatment groups||0.96|0.86|<0.001
72601376|NCT01133704|144731681|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.09||||0.719|TWO_SIDED|95.0|0.69|1.7|||Log Rank||Obtained from a Cox proportional hazards model with treatment group as the independent variable, stratified by bisphosphonate use (placebo/sipuleucel-T)|||1.70|0.69|0.719
72601377|NCT01133704|144731682|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.27||||0.331|TWO_SIDED|95.0|0.78|2.07|||Log Rank||Obtained from a Cox proportional hazards model with treatment as the independent variable, and stratified by bisphosphonate use (placebo/sipuleucel-T).|||2.07|0.78|0.331
72601378|NCT04304508|144731690|OTHER|Dose-response test by using multiple comparison procedures (MCP) Mod.||||||0.7976|||||||MCP Mod|||Dose-response test||||0.7976
72601379|NCT04304508|144731690|OTHER||Crude incidence ratio|1.044|||||TWO_SIDED|90.0|0.8105|1.3478||||||Comparison of the Asundexian 10 mg group versus Placebo group.||1.3478|0.8105|
72601380|NCT04304508|144731690|OTHER||Crude incidence ratio|1.1963|||||TWO_SIDED|90.0|0.9281|1.5428||||||Comparison of the Asundexian 20 mg group versus Placebo group.||1.5428|0.9281|
72601381|NCT04304508|144731690|OTHER||Crude incidence ratio|1.0485|||||TWO_SIDED|90.0|0.8082|1.3619||||||Comparison of the Asundexian 50 mg group versus Placebo group.||1.3619|0.8082|
72601382|NCT04304508|144731698|OTHER|Cause specific HRs were only calculated if at least 3 events occurred in 1 of the compared groups and at least 1 event in each of the compared treatment groups.|Cox Proportional Hazard|1.724|||=|0.1507|TWO_SIDED|90.0|0.924|3.215|||Log Rank|||Comparison of the Asundexian 10 mg group versus Placebo group||3.215|0.924|= 0.1507
72416169|NCT04402866|144343194|OTHER|Since this was a Phase 2 study, it was not powered for any of the secondary endpoints.|Odds Ratio (OR)|1.295||||0.399|TWO_SIDED|95.0|0.702|2.388|||Van Elteren test|||Part 2: TD-0903 - Parallel-Group 3 mg versus Part 2: Matching Placebo - Parallel-Group on Day 21|Between-group comparisons analyzed using a proportional odds model adjusting for baseline age strata (≤ 60 years vs. \> 60 years).|2.388|0.702|0.3990
72416170|NCT04402866|144343194|OTHER|Since this was a Phase 2 study, it was not powered for any of the secondary endpoints.|Odds Ratio (OR)|1.18||||0.6445|TWO_SIDED|95.0|0.605|2.299|||Van Elteren test||Between-group comparisons analyzed using a proportional odds model adjusting for baseline age strata (≤ 60 years vs. \> 60 years).|Part 2: TD-0903 - Parallel-Group 3 mg versus Part 2: Matching Placebo - Parallel-Group on Day 28||2.299|0.605|0.6445
72601383|NCT04304508|144731698|OTHER|Cause specific HRs were only calculated if at least 3 events occurred in 1 of the compared groups and at least 1 event in each of the compared treatment groups.|Cox Proportional Hazard|1.285|||=|0.5339|TWO_SIDED|90.0|0.662|2.494|||Log Rank|||Comparison of the Asundexian 20 mg group versus Placebo group||2.494|0.662|= 0.5339
72416171|NCT04402866|144343195|OTHER|Since this was a Phase 2 study, it was not powered for any of the secondary endpoints.|Risk Difference (RD)|5.06||||0.3005|TWO_SIDED|95.0|-4.5|14.63||The p-value was calculated using the Cochran-Mantel-Haenszel chi-square test stratified by baseline age group (≤ 60 years vs. \> 60 years)|Cochran-Mantel-Haenszel chi-square test|||Part 2: TD-0903 - Parallel-Group 3 mg versus Part 2: Matching Placebo - Parallel-Group||14.63|-4.50|0.3005
72416172|NCT00386880|144343204|SUPERIORITY_OR_OTHER|||||||0.59||||||Fisher's exact test.|Fisher Exact|||During the acute migraine attack, 90% of allodynic subjects and 75% of subjects without allodynia had phonophobia.||||0.59
72416173|NCT00868439|144343205|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||ANCOVA|||||||< 0.001
72416174|NCT00868439|144343206|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.027|TWO_SIDED||||||Fisher Exact|||||||= 0.027
72601384|NCT04304508|144731698|OTHER|Cause specific HRs were only calculated if at least 3 events occurred in 1 of the compared groups and at least 1 event in each of the compared treatment groups.|Cox Proportional Hazard|1.749|||=|0.1401|TWO_SIDED|90.0|0.938|3.262|||Log Rank|||Comparison of the Asundexian 50 mg group versus Placebo group||3.262|0.938|= 0.1401
72601385|NCT04304508|144731698|OTHER|Cause specific HRs were only calculated if at least 3 events occurred in 1 of the compared groups and at least 1 event in each of the compared treatment groups.|Cox Proportional Hazard|1.585|||=|0.1653|TWO_SIDED|90.0|0.918|2.736|||Log Rank|||Comparison of the Total Asundexian group versus Placebo group||2.736|0.918|= 0.1653
72601386|NCT00885378|144731716|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.51|STANDARD_ERROR_OF_MEAN|6.162||0.1248|TWO_SIDED|95.0|-21.68|2.66|||ANCOVA|ANCOVA model: post - pre = pretreatment.|Estimate = adjusted mean change for Saxagliptin - adjusted mean change for Placebo.|||2.66|-21.68|0.1248
72416175|NCT00868439|144343207|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.101|TWO_SIDED||||||Fisher Exact|||||||= 0.101
72601387|NCT00885378|144731717|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.2|||||TWO_SIDED|95.0|1.1|25.4|||||Adjusted for baseline.|||25.4|1.1|
72601388|NCT00885378|144731718|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.8|||||TWO_SIDED|95.0|3.0|24.7|||||Adjusted for baseline.|||24.7|3.0|
72601389|NCT00885378|144731725|SUPERIORITY_OR_OTHER||Standard Error of the Mean|-0.34||||0.0063|TWO_SIDED|95.0|-0.58|-0.1||Between-group comparisons significant at alpha = 0.05, significance testing based on hierarchical testing.|ANCOVA|Adjusted mean difference for saxagliptin groups vs placebo at Week 12(LOCF) was adjusted for baseline.|difference between week t value - baseline value = baseline value + treatment.|||-0.10|-0.58|0.0063
72601390|NCT05725824|144731755|SUPERIORITY||||||<|0.05|||||||Repeated Measure Analysis of Variance|||||||<0.05
72601391|NCT05725824|144731756|SUPERIORITY||||||<|0.05|||||||Repeated Measure Analysis of Variance|||||||<0.05
72601392|NCT05725824|144731757|SUPERIORITY||||||<|0.05||||||Arms/Groups were collapsed for RM-ANOVA to compare between various earmold types. A post-hoc paired t-test w/ Bonferroni correction was utilized to compare ear mold material types.|Repeated Measure Analysis of Variance|||||||<0.05
72601393|NCT05725824|144731758|SUPERIORITY||||||<|0.05|||||||Repeated Measure Analysis of Variance|||||||<0.05
72601394|NCT03252145|144731803|OTHER|||||||0.096|||||||t-test, 2 sided|||||||0.096
72601395|NCT03252145|144731804|OTHER|||||||0.206|||||||t-test, 2 sided|||||||0.206
72601396|NCT03252145|144731805|OTHER|||||||0.096|||||||t-test, 2 sided|||||||0.096
72601397|NCT03252145|144731806|OTHER|||||||0.206|||||||t-test, 2 sided|||||||0.206
72601398|NCT03252145|144731807|OTHER|||||||0.552|||||||t-test, 2 sided|||||||0.552
72601399|NCT03252145|144731808|OTHER|||||||0.498|||||||t-test, 2 sided|||||||0.498
72601400|NCT03252145|144731809|OTHER|||||||0.264|||||||t-test, 2 sided|||Affected Arm Only||||0.264
72601401|NCT03252145|144731809|OTHER|||||||0.224|||||||t-test, 2 sided|||Unaffected arm||||0.224
72416176|NCT00868439|144343208|SUPERIORITY_OR_OTHER_LEGACY|||||||0.022|TWO_SIDED||||||Fisher Exact|||||||0.022
72416177|NCT00868439|144343209|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.136|TWO_SIDED||||||Fisher Exact|||||||= 0.136
72416178|NCT00868439|144343210|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.015|TWO_SIDED||||||Fisher Exact|||||||= 0.015
72416179|NCT04149405|144343212|OTHER||Mean Difference (Final Values)|0.01|||<|0.01|TWO_SIDED||||||Kruskal-Wallis|||||||<0.01
72601402|NCT03252145|144731810|OTHER|||||||0.125|||||||t-test, 2 sided|||Affected arm||||0.125
72601403|NCT03252145|144731810|OTHER|||||||0.241|||||||t-test, 2 sided|||Unaffected arm||||0.241
72601404|NCT03252145|144731811|OTHER|||||||0.261|||||||t-test, 2 sided|||Affected Arm||||0.261
72601405|NCT03252145|144731811|OTHER|||||||0.597|||||||t-test, 2 sided|||Unaffected Arm||||0.597
72601406|NCT03252145|144731812|OTHER|||||||0.596|||||||t-test, 2 sided|||Affected arm||||0.596
72601407|NCT03252145|144731812|OTHER|||||||0.219|||||||t-test, 2 sided|||Unaffected arm||||0.219
72601408|NCT03252145|144731813|OTHER|||||||0.842|||||||t-test, 2 sided|||||||0.842
72601409|NCT03252145|144731814|OTHER|||||||0.772|||||||t-test, 2 sided|||||||0.772
72601410|NCT03252145|144731815|OTHER|||||||0.3|||||||t-test, 2 sided|||||||0.300
72601411|NCT03252145|144731816|OTHER|||||||0.3|||||||t-test, 2 sided|||||||0.300
72601412|NCT03252145|144731817|OTHER|||||||0.679|||||||t-test, 2 sided|||||||0.679
72601413|NCT03252145|144731818|OTHER|||||||0.12|||||||t-test, 2 sided|||||||0.120
72601414|NCT03252145|144731819|OTHER|||||||0.138|||||||t-test, 2 sided|||||||0.138
72601415|NCT03252145|144731820|OTHER|||||||0.096|||||||t-test, 2 sided|||||||0.096
72601416|NCT03252145|144731821|OTHER|||||||0.206|||||||t-test, 2 sided|||||||0.206
72601417|NCT03252145|144731823|OTHER|||||||0.08|||||||t-test, 2 sided|||||||0.080
72601418|NCT03252145|144731824|OTHER|||||||0.068|||||||t-test, 2 sided|||Physical Function Domain||||0.068
72601419|NCT03252145|144731824|OTHER|||||||0.808|||||||t-test, 2 sided|||Anxiety Domain||||0.808
72601420|NCT03252145|144731824|OTHER|||||||0.557|||||||t-test, 2 sided|||Depression Domain||||0.557
72601421|NCT03252145|144731824|OTHER|||||||0.049|||||||t-test, 2 sided|||Fatigue Domain||||0.049
72601422|NCT03252145|144731824|OTHER|||||||0.279|||||||t-test, 2 sided|||Sleep Disturbance Domain||||0.279
72601423|NCT03252145|144731824|OTHER|||||||0.02|||||||t-test, 2 sided|||Roles/Activity Domain||||0.020
72601424|NCT03252145|144731824|OTHER|||||||0.009|||||||t-test, 2 sided|||Pain Interference Domain||||0.009
72601425|NCT03252145|144731825|OTHER|||||||0.038|||||||t-test, 2 sided|||Physical Function Domain||||0.038
72601426|NCT03252145|144731825|OTHER|||||||0.108|||||||t-test, 2 sided|||Anxiety Domain||||0.108
72601427|NCT03252145|144731825|OTHER|||||||0.467|||||||t-test, 2 sided|||Depression Domain||||0.467
72601428|NCT03252145|144731825|OTHER|||||||0.078|||||||t-test, 2 sided|||Fatigue Domain||||0.078
72416180|NCT04149405|144343213|OTHER||||||<|0.05|||||||Kruskal-Wallis|||||||<0.05
72601429|NCT03252145|144731825|OTHER|||||||0.147|||||||t-test, 2 sided|||Sleep Disturbance Domain||||0.147
72601430|NCT03252145|144731825|OTHER|||||||0.004|||||||t-test, 2 sided|||Roles/Activity Domain||||0.004
72601431|NCT03252145|144731825|OTHER|||||||0.032|||||||t-test, 2 sided|||Pain Interference Domain||||0.032
72601432|NCT03252145|144731826|OTHER|||||||0.938|||||||t-test, 2 sided|||||||0.938
72601433|NCT03252145|144731827|OTHER|||||||0.603|||||||t-test, 2 sided|||||||0.603
72601434|NCT03252145|144731828|OTHER|||||||0.837|||||||t-test, 2 sided|||||||0.837
72601435|NCT03252145|144731829|OTHER|||||||0.511|||||||t-test, 2 sided|||||||0.511
72601436|NCT03252145|144731830|OTHER|||||||0.326|||||||t-test, 2 sided|||||||0.326
72416181|NCT04149405|144343214|OTHER||||||<|0.05|||||||Kruskal-Wallis|||||||<0.05
72416182|NCT04149405|144343215|OTHER||||||<|0.05|||||||Kruskal-Wallis|||||||<0.05
72601437|NCT04336475|144731838|SUPERIORITY|||||||0.564||||||The threshold for statistical significance was p=0.05. p value stands for the comparison of final oral aperture measurements between two groups. (after 2 months' period)|ANOVA|Repeated Measures ANOVA||||||0.564
72601438|NCT01267929|144731844|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.1|STANDARD_ERROR_OF_MEAN|2.14||0.34|TWO_SIDED|95.0|-2.3|6.5||Statistical analysis was conducted using STATA. Analysis of Covariance (ANCOVA) was used to compare mean score of GMFM at the second month between two groups.|ANCOVA|||A sample size of 30 children, 15 for each group, was needed to obtain 80% power at 0.05 level of significance (two-sided) to test that the successful event rate (increasing GMFM scores at least 30% from baseline at the end of 2 months) in experimental group and control group of 0.3 and 0.8 respectively. The mean changes of GMFM total scores in the experimental group at the second month compared to those in the control group after adjusted for the baseline level.||6.5|-2.3|0.34
72601439|NCT01267929|144731844|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.7|STANDARD_ERROR_OF_MEAN|2.7||0.78|TWO_SIDED|95.0|-6.3|4.7||Statistical analysis was conducted using STATA. Analysis of Covariance (ANCOVA) was used to compare mean score of GMFM at the sixth month between two groups.|ANCOVA|||A sample size of 30 children, 15 for each group, was needed to obtain 80% power at 0.05 level of significance (two-sided) to test that the successful event rate (increasing GMFM scores at least 30% from baseline at the end of 2 months) in experimental group and control group of 0.3 and 0.8 respectively. The mean changes of GMFM total scores in the experimental group at the sixth month compared to those in the control group after adjusted for the baseline level.||4.7|-6.3|0.78
72601440|NCT03498313|144731852|SUPERIORITY||Slope|-0.25|STANDARD_ERROR_OF_MEAN|0.082||0.002|TWO_SIDED|95.0|-0.41|-0.08|||Mixed Models Analysis|This is the p-value for the Treatment X Cycle Phase Interaction. Kenward-Roger Method was utilized for degrees of freedom.|Placebo represents the reference treatment.|Fixed interaction effect of treatment (0=Placebo, 1=E2) by cycle phase (0=Lower-Risk Early Luteal Baseline, 1=Higher-Risk Perimenstrual Phase) predicting SI severity in a multilevel model (with daily observations nested within conditions nested within participants over time).||-.08|-.41|.002
72601441|NCT03498313|144731852|SUPERIORITY||Slope|-0.06|STANDARD_ERROR_OF_MEAN|0.083||0.46|TWO_SIDED|95.0|-0.22|0.1|||Mixed Models Analysis|This is the p-value for the Treatment X Cycle Phase Interaction. Kenward-Roger Method was utilized for degrees of freedom.|Placebo Represents the Reference Condition.|Fixed interaction effect of treatment (0=Placebo, 1=P4) by cycle phase (0=Lower-Risk Early Luteal Baseline, 1=Higher-Risk Perimenstrual Phase) predicting SI severity in a multilevel model (with daily observations nested within conditions nested within participants over time).||.10|-.22|.46
72601442|NCT02171429|144731853|SUPERIORITY||Difference in Remission Rates|7.2||||0.1729|TWO_SIDED|95.0|-3.83|16.12||The threshold for statistical significance was a p-value \<0.05.|Cochran-Mantel-Haenszel|Difference and 95% CI adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL) and MCS (≤9 or ≥10) at BL.|Difference in remission rates was calculated as the etrolizumab arm minus the placebo arm.|The null hypothesis (H0): the percentage of participants achieving remission at Week 10 was the same in both the placebo and etrolizumab arms. The alternative hypothesis (H1): the percentage of participants achieving remission at Week 10 was not the same in the placebo and etrolizumab arms.||16.12|-3.83|0.1729
72601443|NCT02171429|144731854|SUPERIORITY||Difference in Remission Rates|-6.8||||0.1458|TWO_SIDED|95.0|-16.26|2.73||Nominal p-value; it has not been adjusted for multiplicity.|Cochran-Mantel-Haenszel|Difference and 95% CI adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL) and MCS (≤9 or ≥10) at BL.|Difference in remission rates was calculated as the etrolizumab arm minus the adalimumab arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. Please refer to the statistical analysis plan for details. This comparison was not considered a key secondary outcome measure and was not part of the multiple testing procedure for statistical significance.||2.73|-16.26|0.1458
72601444|NCT02171429|144731855|SUPERIORITY||Difference in Remission Rates|-5.0||||1|TWO_SIDED|95.0|-11.66|1.75||p-value has been adjusted for multiplicity.|Cochran-Mantel-Haenszel|Difference and 95% CI adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL) and MCS (≤9 or ≥10) at BL.|Difference in remission rates was calculated as the etrolizumab arm minus the adalimumab arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. This comparison was part of Family 3 of the testing procedure; please refer to the statistical analysis plan for details.||1.75|-11.66|1
72601445|NCT02171429|144731856|SUPERIORITY||Difference in Response Rates|14.0||||0.1729|TWO_SIDED|95.0|-0.12|27.19||p-value has been adjusted for multiplicity.|Cochran-Mantel-Haenszel|Difference and 95% CI adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL) and MCS (≤9 or ≥10) at BL.|Difference in response rates was calculated as the etrolizumab arm minus the placebo arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. This comparison was part of Family 1 of the testing procedure; please refer to the statistical analysis plan for details.||27.19|-0.12|0.1729
72416183|NCT04109703|144343225|OTHER|The hypothesis is that the high level pulsed heat group will show statistically more pain relief than the low level steady heat group.|||||<|0.05|||||||Regression, Linear|Linear regression was used to compare differences in primary outcome between treatment and control groups adjusting for initial pain level.||Demographic and clinical characteristics were tabulated by randomization group. The primary outcome was change in pain score from baseline to 30 minutes after treatment ended. Linear regression was used to compare differences in primary outcome between treatment and control groups adjusting for initial pain level. Unadjusted comparisons are also presented. Change in pain scores at each other post baseline time point were similarly analyzed.||||<0.05
72416184|NCT02167074|144343232|OTHER|The chi-square test (with Yates' correction when appropriate) or the Fisher exact test was used to compare the two needle types|||||<|0.05|||||||Chi-squared|||||||<0.05
72416185|NCT01654549|144343236|SUPERIORITY_OR_OTHER|||||||0.94|TWO_SIDED|95.0|||||t-test, 2 sided|||||||0.94
72416186|NCT01654549|144343236|SUPERIORITY_OR_OTHER|||||||0.78||95.0|||||t-test, 2 sided|||||||0.78
72416187|NCT01654549|144343236|SUPERIORITY_OR_OTHER||||||<|0.01||95.0|||||Paired t-test|||||||<0.01
72416188|NCT01654549|144343236|SUPERIORITY_OR_OTHER||||||<|0.01||95.0|||||Paired t-test|||||||<0.01
72416189|NCT01654549|144343236|SUPERIORITY_OR_OTHER|||||||0.1||95.0|||||t-test, 2 sided|||||||0.10
72601446|NCT02171429|144731856|SUPERIORITY||Difference in Response Rates|-2.5||||0.6726|TWO_SIDED|95.0|-13.83|9.01||Nominal p-value; it has not been adjusted for multiplicity.|Cochran-Mantel-Haenszel|Difference and 95% CI adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL) and MCS (≤9 or ≥10) at BL.|Difference in response rates was calculated as the etrolizumab arm minus the adalimumab arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. Please refer to the statistical analysis plan for details. This comparison was not considered a key secondary outcome measure and was not part of the multiple testing procedure for statistical significance.||9.01|-13.83|0.6726
72601447|NCT02171429|144731857|SUPERIORITY||Difference in Response Rates|1.2||||1|TWO_SIDED|95.0|-6.98|9.26||p-value has been adjusted for multiplicity.|Cochran-Mantel-Haenszel|Difference and 95% CI adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL) and MCS (≤9 or ≥10) at BL.|Difference in response rates was calculated as the etrolizumab arm minus the adalimumab arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. This comparison was part of Family 3 of the testing procedure; please refer to the statistical analysis plan for details.||9.26|-6.98|1
72416190|NCT05072080|144343268|SUPERIORITY||Mean Difference (Final Values)|96.6|||<|0.0001|TWO_SIDED|95.0|95.0|97.5||p-value is from a two-sided chi-square test of equality of seroresponse percentages between groups. All 3 coprimary endpoints were required to be met for success, so no multiple comparisons were performed.|Chi-squared||Seroresponse rate difference is (PXVX0317 minus placebo).|Day 22||97.5|95.0|<0.0001
72416191|NCT05072080|144343270|SUPERIORITY||GMT Ratio|206.0|||<|0.0001|TWO_SIDED|95.0|183.0|232.0||All 3 coprimary endpoints were required to be met for success, so no multiple comparisons were performed.|ANOVA|ANOVA model includes site and treatment group as fixed effects, assuming normality of log titers. p-value tests equivalence of group GMTs on log scale|Ratio of GMTs is (PXVX0317:placebo).|Day 22||232|183|<0.0001
72601448|NCT02171429|144731858|SUPERIORITY||Difference in Response Rates|9.4||||0.2372|TWO_SIDED|95.0|-4.31|21.95||p-value has been adjusted for multiplicity.|Cochran-Mantel-Haenszel|Difference and 95% CI adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL) and MCS (≤9 or ≥10) at BL.|Difference in response rates was calculated as the etrolizumab arm minus the placebo arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. This comparison was part of Family 1 of the testing procedure; please refer to the statistical analysis plan for details.||21.95|-4.31|0.2372
72601449|NCT02171429|144731858|SUPERIORITY||Difference in Response Rates|-3.5||||0.5341|TWO_SIDED|95.0|-14.76|7.82||Nominal p-value; it has not been adjusted for multiplicity.|Cochran-Mantel-Haenszel|Difference and 95% CI adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL) and MCS (≤9 or ≥10) at BL.|Difference in response rates was calculated as the etrolizumab arm minus the adalimumab arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. Please refer to the statistical analysis plan for details. This comparison was not considered a key secondary outcome measure and was not part of the multiple testing procedure for statistical significance.||7.82|-14.76|0.5341
72601450|NCT02171429|144731859|SUPERIORITY||Difference in Response Rates|1.9||||1|TWO_SIDED|95.0|-6.04|9.88||p-value has been adjusted for multiplicity.|Cochran-Mantel-Haenszel|Difference and 95% CI adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL) and MCS (≤9 or ≥10) at BL.|Difference in response rates was calculated as the etrolizumab arm minus the adalimumab arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. This comparison was part of Family 3 of the testing procedure; please refer to the statistical analysis plan for details.||9.88|-6.04|1
72601451|NCT02171429|144731860|SUPERIORITY||Difference in Remission Rates|11.2||||0.2372|TWO_SIDED|95.0|0.59|19.76||p-value has been adjusted for multiplicity.|Cochran-Mantel-Haenszel|Difference and 95% CI adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL) and MCS (≤9 or ≥10) at BL.|Difference in remission rates was calculated as the etrolizumab arm minus the placebo arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. This comparison was part of Family 2 of the testing procedure; please refer to the statistical analysis plan for details.||19.76|0.59|0.2372
72416192|NCT05072080|144343272|EQUIVALENCE|Success criterion was pairwise GMT ratios (104:105, 105:106, 104:106) each with a two-sided 95% CI within \[0.667; 1.5\].|GMT Ratio|0.98|||||TWO_SIDED|95.0|0.85|1.14|||||All 3 coprimary endpoints were required to be met for success, so no multiple comparisons were performed. GMT estimates and 95% CIs are derived from an ANOVA model that includes site and product lot as fixed effects assuming normality of log titers.|||1.14|0.85|
72416193|NCT05072080|144343272|EQUIVALENCE|Success criterion was pairwise GMT ratios (104:105, 105:106, 104:106) each with a two-sided 95% CI within \[0.667; 1.5\].|GMT Ratio|0.97|||||TWO_SIDED|95.0|0.84|1.12|||||All 3 coprimary endpoints were required to be met for success, so no multiple comparisons were performed. GMT estimates and 95% CIs are derived from an ANOVA model that includes site and product lot as fixed effects assuming normality of log titers.|||1.12|0.84|
72416194|NCT05072080|144343272|EQUIVALENCE|Success criterion was pairwise GMT ratios (104:105, 105:106, 104:106) each with a two-sided 95% CI within \[0.667; 1.5\].|GMT Ratio|0.95|||||TWO_SIDED|95.0|0.82|1.1|||||All 3 coprimary endpoints were required to be met for success, so no multiple comparisons were performed. GMT estimates and 95% CIs are derived from an ANOVA model that includes site and product lot as fixed effects assuming normality of log titers.|||1.10|0.82|
72416195|NCT05072080|144343274|SUPERIORITY||Mean Difference (Final Values)|96.0|||<|0.0001|TWO_SIDED|95.0|94.3|96.8||Key secondary endpoints were tested hierarchically, such that each was only tested if all 3 coprimary endpoints and prior key secondary endpoints were met, so no multiple comparisons were performed.|Chi-squared|p-value is from a two-sided chi-square test of equality of seroresponse percentages between groups.|Seroresponse rate difference is (PXVX0317 minus placebo).|Day 15||96.8|94.3|<0.0001
72416196|NCT05072080|144343274|SUPERIORITY||Mean Difference (Final Values)|84.0|||<|0.0001|TWO_SIDED|95.0|81.7|85.6||Key secondary endpoints were tested hierarchically, such that each was only tested if all 3 coprimary endpoints and prior key secondary endpoints were met, so no multiple comparisons were performed.|Chi-squared|p-value is from a two-sided chi-square test of equality of seroresponse percentages between groups.|Seroresponse rate difference is (PXVX0317 minus placebo).|Day 183||85.6|81.7|<0.0001
72416197|NCT05072080|144343274|SUPERIORITY||Mean Difference (Final Values)|46.1|||<|0.0001|TWO_SIDED|95.0|43.8|48.1||Key secondary endpoints were tested hierarchically, such that each was only tested if all 3 coprimary endpoints and prior key secondary endpoints were met, so no multiple comparisons were performed.|Chi-squared|p-value is from a two-sided chi-square test of equality of seroresponse percentages between groups.|Seroresponse rate difference is (PXVX0317 minus placebo).|Day 8||48.1|43.8|<0.0001
72416198|NCT05072080|144343276|SUPERIORITY||GMT Ratio|13.0|||<|0.0001|TWO_SIDED|95.0|11.0|14.0|||ANOVA|ANOVA model includes site and treatment group as fixed effects, assuming normality of log titers. p-value tests equivalence of group GMTs on log scale|Ratio of GMTs is (PXVX0317:placebo)|Day 8||14|11|<0.0001
72416199|NCT05072080|144343276|SUPERIORITY||GMT Ratio|144.0|||<|0.0001|TWO_SIDED|95.0|128.0|162.0|||ANOVA|ANOVA model includes site and treatment group as fixed effects, assuming normality of log titers. p-value tests equivalence of group GMTs on log scale|Ratio of GMTs is (PXVX0317:placebo)|Day 15||162|128|<0.0001
72416200|NCT05072080|144343276|SUPERIORITY||GMT Ratio|41.0|||<|0.0001|TWO_SIDED|95.0|37.0|46.0|||ANOVA|ANOVA model includes site and treatment group as fixed effects, assuming normality of log titers. p-value tests equivalence of group GMTs on log scale|Ratio of GMTs is (PXVX0317:placebo)|Day 183||46|37|<0.0001
72416201|NCT05072080|144343278|SUPERIORITY||||||<|0.0001||||||GMFI estimates and 95% CIs are based on t-statistics assuming a normal distribution of the log fold increase in titer. p-value tests equality of log fold increase in titer between groups.|t-test, 2 sided|||Day 8||||<0.0001
72416202|NCT05072080|144343278|SUPERIORITY||||||<|0.0001||||||GMFI estimates and 95% CIs are based on t-statistics assuming a normal distribution of the log fold increase in titer. p-value tests equality of log fold increase in titer between groups.|t-test, 2 sided|||Day 15||||<0.0001
72416203|NCT05072080|144343278|SUPERIORITY||||||<|0.0001||||||GMFI estimates and 95% CIs are based on t-statistics assuming a normal distribution of the log fold increase in titer. p-value tests equality of log fold increase in titer between groups.|t-test, 2 sided|||Day 22||||<0.0001
72416204|NCT05072080|144343278|SUPERIORITY||||||<|0.0001||||||GMFI estimates and 95% CIs are based on t-statistics assuming a normal distribution of the log fold increase in titer. p-value tests equality of log fold increase in titer between groups.|t-test, 2 sided|||Day 183||||<0.0001
72416205|NCT05072080|144343280|SUPERIORITY||Mean Difference (Final Values)|90.7|||<|0.0001|TWO_SIDED|95.0|88.7|91.9|||Chi-squared|p-value is from a two-sided chi-square test of equality of seroresponse percentages between groups.|Seroresponse rate difference is (PXVX0317 minus placebo).|SNA titers ≥15 at Day 8||91.9|88.7|<0.0001
72416206|NCT05072080|144343280|SUPERIORITY||Mean Difference (Final Values)|98.7|||<|0.0001|TWO_SIDED|95.0|97.2|99.3||p-value is from a two-sided chi-square test of equality of seroresponse percentages between groups.|Chi-squared||Seroresponse rate difference is (PXVX0317 minus placebo).|SNA titers ≥15 at Day 15||99.3|97.2|<0.0001
72416207|NCT05072080|144343280|SUPERIORITY||Mean Difference (Final Values)|97.6|||<|0.0001|TWO_SIDED|95.0|95.8|98.5|||Chi-squared|p-value is from a two-sided chi-square test of equality of seroresponse percentages between groups.|Seroresponse rate difference is (PXVX0317 minus placebo).|SNA titers ≥15 at Day 22||98.5|95.8|<0.0001
72416208|NCT05072080|144343280|SUPERIORITY||Mean Difference (Final Values)|96.8|||<|0.0001|TWO_SIDED|95.0|94.8|97.9|||Chi-squared|p-value is from a two-sided chi-square test of equality of seroresponse percentages between groups.|Seroresponse rate difference is (PXVX0317 minus placebo).|SNA titers ≥15 at Day 183||97.9|94.8|<0.0001
72416209|NCT05072080|144343280|SUPERIORITY||Mean Difference (Final Values)|64.8|||<|0.0001|TWO_SIDED|95.0|62.5|66.7|||Chi-squared|p-value is from a two-sided chi-square test of equality of seroresponse percentages between groups.|Seroresponse rate difference is (PXVX0317 minus placebo).|≥4-fold rise over baseline at Day 8||66.7|62.5|<0.0001
72416210|NCT05072080|144343280|SUPERIORITY||Mean Difference (Final Values)|97.8|||<|0.0001|TWO_SIDED|95.0|96.3|98.4|||Chi-squared|p-value is from a two-sided chi-square test of equality of seroresponse percentages between groups.|Seroresponse rate difference is (PXVX0317 minus placebo).|≥4-fold rise over baseline at Day 15||98.4|96.3|<0.0001
72601452|NCT02171429|144731860|SUPERIORITY||Difference in Remission Rates|-7.5||||0.1192|TWO_SIDED|95.0|-17.2|2.33||Nominal p-value; it has not been adjusted for multiplicity.|Cochran-Mantel-Haenszel|Difference and 95% CI adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL) and MCS (≤9 or ≥10) at BL.|Difference in remission rates was calculated as the etrolizumab arm minus the adalimumab arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. Please refer to the statistical analysis plan for details. This comparison was not considered a key secondary outcome measure and was not part of the multiple testing procedure for statistical significance.||2.33|-17.20|0.1192
72601453|NCT02171429|144731861|SUPERIORITY||Difference in Remission Rates|-3.5||||1|TWO_SIDED|95.0|-10.27|3.3||p-value has been adjusted for multiplicity.|Cochran-Mantel-Haenszel|Difference and 95% CI adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL) and MCS (≤9 or ≥10) at BL.|Difference in remission rates was calculated as the etrolizumab arm minus the adalimumab arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. This comparison was part of Family 5 of the testing procedure; please refer to the statistical analysis plan for details.||3.30|-10.27|1
72416211|NCT05072080|144343280|SUPERIORITY||Mean Difference (Final Values)|97.2|||<|0.0001|TWO_SIDED|95.0|95.5|98.1|||Chi-squared|p-value is from a two-sided chi-square test of equality of seroresponse percentages between groups.|Seroresponse rate difference is (PXVX0317 minus placebo).|≥4-fold rise over baseline at Day 22||98.1|95.5|<0.0001
72601454|NCT02171429|144731862|SUPERIORITY||Difference in Remission Rates|9.6||||0.2729|TWO_SIDED|95.0|-4.71|22.02||p-value has been adjusted for multiplicity.|Cochran-Mantel-Haenszel|Difference and 95% CI adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL) and MCS (≤9 or ≥10) at BL.|Difference in remission rates was calculated as the etrolizumab arm minus the placebo arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. This comparison was part of Family 2 of the testing procedure; please refer to the statistical analysis plan for details.||22.02|-4.71|0.2729
72601455|NCT02171429|144731862|SUPERIORITY||Difference in Remission Rates|-14.8||||0.0215|TWO_SIDED|95.0|-26.97|-2.04||Nominal p-value; it has not been adjusted for multiplicity.|Cochran-Mantel-Haenszel|Difference and 95% CI adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL) and MCS (≤9 or ≥10) at BL.|Difference in remission rates was calculated as the etrolizumab arm minus the adalimumab arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. Please refer to the statistical analysis plan for details. This comparison was not considered a key secondary outcome measure and was not part of the multiple testing procedure for statistical significance.||-2.04|-26.97|0.0215
72601456|NCT02171429|144731863|SUPERIORITY||Difference in Remission Rates|-0.3||||1|TWO_SIDED|95.0|-9.13|8.45||p-value has been adjusted for multiplicity.|Cochran-Mantel-Haenszel|Difference and 95% CI adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL) and MCS (≤9 or ≥10) at BL.|Difference in remission rates was calculated as the etrolizumab arm minus the adalimumab arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. This comparison was part of Family 5 of the testing procedure; please refer to the statistical analysis plan for details.||8.45|-9.13|1
72416212|NCT05072080|144343280|SUPERIORITY||Mean Difference (Final Values)|91.4|||<|0.0001|TWO_SIDED|95.0|89.4|92.7|||Chi-squared|p-value is from a two-sided chi-square test of equality of seroresponse percentages between groups.|Seroresponse rate difference is (PXVX0317 minus placebo).|≥4-fold rise over baseline at Day 183||92.7|89.4|<0.0001
72416213|NCT01043432|144343282|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Regression, Linear|||Linear regressions were utilized to model the outcomes of interest as a function of SA, TBI group, and the interaction between the two groups.||||>.05
72421627|NCT03720938|144354389|SUPERIORITY|||||||0.005||||||Linear mixed-effects model fit by maximum likelihood since restricted maximum likelihood assumes a strong normality.|Linear mixed effects model|Adjusted by Satterthwaite's degrees of freedom method for cluster effect, and small sample sizes in addition to baseline value and age.||Null hypothesis was the absence of difference between the two groups for the dependent variable self-perception of global physical self-worth.||||0.005
72601457|NCT02171429|144731864|SUPERIORITY|||||||0.1729||||||p-value has been adjusted for multiplicity.|Rank ANCOVA|Model adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL), MCS (≤9 or ≥10) at BL, and RB score at BL.||Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. This comparison was part of Family 2 of the testing procedure; please refer to the statistical analysis plan for details.||||0.1729
72601458|NCT02171429|144731864|SUPERIORITY|||||||0.2864||||||Nominal p-value; it has not been adjusted for multiplicity.|Rank ANCOVA|Model adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL), MCS (≤9 or ≥10) at BL, and RB score at BL.||Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. Please refer to the statistical analysis plan for details. This comparison was not considered a key secondary outcome measure and was not part of the multiple testing procedure for statistical significance.||||0.2864
72601459|NCT02171429|144731865|SUPERIORITY|||||||1||||||p-value has been adjusted for multiplicity.|Rank ANCOVA|Model adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL), MCS (≤9 or ≥10) at BL, and RB score at BL.||Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. This comparison was part of Family 5 of the testing procedure; please refer to the statistical analysis plan for details.||||1
72601460|NCT02171429|144731866|SUPERIORITY|||||||0.1729||||||p-value has been adjusted for multiplicity.|Rank ANCOVA|Model adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL), MCS (≤9 or ≥10) at BL, and SF score at BL.||Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. This comparison was part of Family 2 of the testing procedure; please refer to the statistical analysis plan for details.||||0.1729
72601461|NCT02171429|144731866|SUPERIORITY|||||||0.4174||||||Nominal p-value; it has not been adjusted for multiplicity.|Rank ANCOVA|Model adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL), MCS (≤9 or ≥10) at BL, and SF score at BL.||Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. Please refer to the statistical analysis plan for details. This comparison was not considered a key secondary outcome measure and was not part of the multiple testing procedure for statistical significance.||||0.4174
72601462|NCT02171429|144731867|SUPERIORITY|||||||1||||||p-value has been adjusted for multiplicity.|Rank ANCOVA|Model adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL), MCS (≤9 or ≥10) at BL, and SF score at BL.||Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. This comparison was part of Family 5 of the testing procedure; please refer to the statistical analysis plan for details.||||1
72601463|NCT02171429|144731868|SUPERIORITY||Mean Difference (Net)|-1.1||||0.1659|TWO_SIDED|95.0|-2.8|0.5||Nominal p-value; it has not been adjusted for multiplicity.|Mixed Model for Repeated Measures|Model adjusted for treatment, visit, stratification factors, treatment-by-visit, baseline UC-PRO/SS domain, and baseline UC-PRO/SS domain-by-visit.|Mean difference was calculated as etrolizumab arm minus placebo arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. Please refer to the statistical analysis plan for details. This comparison was not considered a key secondary outcome measure and was not part of the multiple testing procedure for statistical significance.||0.5|-2.8|0.1659
72601464|NCT02171429|144731868|SUPERIORITY||Mean Difference (Net)|0.1||||0.9182|TWO_SIDED|95.0|-1.3|1.4||Nominal p-value; it has not been adjusted for multiplicity.|Mixed Model for Repeated Measures|Model adjusted for treatment, visit, stratification factors, treatment-by-visit, baseline UC-PRO/SS domain, and baseline UC-PRO/SS domain-by-visit.|Mean difference was calculated as etrolizumab arm minus adalimumab arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. Please refer to the statistical analysis plan for details. This comparison was not considered a key secondary outcome measure and was not part of the multiple testing procedure for statistical significance.||1.4|-1.3|0.9182
72601465|NCT02171429|144731869|SUPERIORITY||Mean Difference (Net)|-1.0||||1|TWO_SIDED|95.0|-2.1|0.2||p-value has been adjusted for multiplicity.|Mixed Model for Repeated Measures|Model adjusted for treatment, visit, stratification factors, treatment-by-visit, baseline UC-PRO/SS domain, and baseline UC-PRO/SS domain-by-visit.|Mean difference was calculated as etrolizumab arm minus placebo arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. This comparison was part of Family 4 of the testing procedure; please refer to the statistical analysis plan for details.||0.2|-2.1|1
72601466|NCT02171429|144731869|SUPERIORITY||Mean Difference (Net)|-0.3||||1|TWO_SIDED|95.0|-1.2|0.7||p-value has been adjusted for multiplicity.|Mixed Model for Repeated Measures|Model adjusted for treatment, visit, stratification factors, treatment-by-visit, baseline UC-PRO/SS domain, and baseline UC-PRO/SS domain-by-visit.|Mean difference was calculated as etrolizumab arm minus adalimumab arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. This comparison was part of Family 6 of the testing procedure; please refer to the statistical analysis plan for details.||0.7|-1.2|1
72601467|NCT02171429|144731870|SUPERIORITY||Mean Difference (Net)|-1.0||||0.0116|TWO_SIDED|95.0|-1.7|-0.2||Nominal p-value; it has not been adjusted for multiplicity.|Mixed Model for Repeated Measures|Model adjusted for treatment, visit, stratification factors, treatment-by-visit, baseline UC-PRO/SS domain, and baseline UC-PRO/SS domain-by-visit.|Mean difference was calculated as etrolizumab arm minus placebo arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. Please refer to the statistical analysis plan for details. This comparison was not considered a key secondary outcome measure and was not part of the multiple testing procedure for statistical significance.||-0.2|-1.7|0.0116
72416214|NCT01972841|144343294|SUPERIORITY||Least squares mean difference|-0.25|STANDARD_ERROR_OF_MEAN|0.12||0.072|TWO_SIDED|95.0|-0.49|-0.01||Nominal p-value|Stratified rank ANCOVA|No adjustment for multiplicity was needed for testing combination therapy vs. its 2 monotherapy components.|Adjustment for multiplicity across primary and the first secondary endpoint as well as across the 2 combination doses was made using a sequential Bonferroni-based testing procedure.|Difference of the adjusted mean calculated by subtracting the adjusted mean of the solifenacin 5 mg monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous overactive bladder medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||-0.01|-0.49|0.072
72416215|NCT01972841|144343294|SUPERIORITY||Least squares mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.12||0.033|TWO_SIDED|95.0|-0.44|0.04||Nominal p-value|Stratified rank ANCOVA|No adjustment for multiplicity was needed for testing combination therapy vs. its 2 monotherapy components.|Adjustment for multiplicity across primary and the first secondary endpoint as well as across the 2 combination doses was made using a sequential Bonferroni-based testing procedure.|Difference of the adjusted mean calculated by subtracting the adjusted mean of the solifenacin 5 mg monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous overactive bladder medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||0.04|-0.44|0.033
72416216|NCT01972841|144343294|SUPERIORITY||Least squares mean difference|-0.34|STANDARD_ERROR_OF_MEAN|0.12||0.001|TWO_SIDED|95.0|-0.58|-0.1|||Stratified rank ANCOVA||Adjustment for multiplicity across primary and the first secondary endpoint as well as across the 2 combination doses was made using a sequential Bonferroni-based testing procedure.|Difference of the adjusted mean calculated by subtracting the adjusted mean of the mirabegron 25 mg monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous overactive bladder medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||-0.10|-0.58|0.001
72416217|NCT01972841|144343294|SUPERIORITY||Least squares mean difference|-0.23|STANDARD_ERROR_OF_MEAN|0.12||0.052|TWO_SIDED|95.0|-0.47|0.01|||Stratified rank ANCOVA|No adjustment for multiplicity was needed for testing combination therapy vs. its 2 monotherapy components.|Adjustment for multiplicity across primary and the first secondary endpoint as well as across the 2 combination doses was made using a sequential Bonferroni-based testing procedure.|Difference of the adjusted mean calculated by subtracting the adjusted mean of the mirabegron 50 mg monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous overactive bladder medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||0.01|-0.47|0.052
72421628|NCT03720938|144354389|SUPERIORITY|||||||0.00603||||||Linear mixed-effects model fit by maximum likelihood since restricted maximum likelihood assumes a strong normality.|Linear mixed-effects model|Adjusted by Satterthwaite's degrees of freedom method for cluster effect, and small sample sizes in addition to baseline value and age.||Null hypothesis was the absence of difference between the two groups for the dependent variable self-perception of global physical self-worth.||||0.00603
72416218|NCT01972841|144343295|SUPERIORITY||Least squares mean difference|-0.29|STANDARD_ERROR_OF_MEAN|0.14||0.04|TWO_SIDED|95.0|-0.57|-0.01||Nominal p-value|ANCOVA|No adjustment for multiplicity was needed for testing combination therapy vs. its 2 monotherapy components.|Adjustment for multiplicity across primary and the first secondary endpoint as well as across the 2 combination doses was made using a sequential Bonferroni-based testing procedure.|Difference of the adjusted mean calculated by subtracting the adjusted mean of the solifenacin 5 mg monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous overactive bladder medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||-0.01|-0.57|0.040
72416219|NCT01972841|144343295|SUPERIORITY||Least squares mean difference|-0.39|STANDARD_ERROR_OF_MEAN|0.14||0.006|TWO_SIDED|95.0|-0.67|-0.11||Nominal p-value|ANCOVA|No adjustment for multiplicity was needed for testing combination therapy vs. its 2 monotherapy components.|Adjustment for multiplicity across primary and the first secondary endpoint as well as across the 2 combination doses was made using a sequential Bonferroni-based testing procedure.|Difference of the adjusted mean calculated by subtracting the adjusted mean of the solifenacin 5 mg monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous overactive bladder medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||-0.11|-0.67|0.006
72416220|NCT01972841|144343295|SUPERIORITY||Least squares mean difference|-0.48|STANDARD_ERROR_OF_MEAN|0.14||0.001|TWO_SIDED|95.0|-0.76|-0.21||Nominal p-value|ANCOVA|No adjustment for multiplicity was needed for testing combination therapy vs. its 2 monotherapy components.|Adjustment for multiplicity across primary and the first secondary endpoint as well as across the 2 combination doses was made using a sequential Bonferroni-based testing procedure.|Difference of the adjusted mean calculated by subtracting the adjusted mean of the mirabegron 25 mg monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous overactive bladder medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||-0.21|-0.76|0.001
72421629|NCT03720938|144354390|SUPERIORITY|||||||0.002879||||||The outcome of self-perception for global self-worth was tested for any difference between groups by covariate analysis.|ANCOVA|Adjusted for self-perception for global self-worth at baseline and confounding variable age.||Null hypothesis was the absence of difference between the two groups for the dependent variable self-perception of global self-worth.||||0.002879
72601468|NCT02171429|144731870|SUPERIORITY||Mean Difference (Net)|-0.1||||0.6771|TWO_SIDED|95.0|-0.8|0.5||Nominal p-value; it has not been adjusted for multiplicity.|Mixed Model for Repeated Measures|Model adjusted for treatment, visit, stratification factors, treatment-by-visit, baseline UC-PRO/SS domain, and baseline UC-PRO/SS domain-by-visit.|Mean difference was calculated as etrolizumab arm minus adalimumab arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. Please refer to the statistical analysis plan for details. This comparison was not considered a key secondary outcome measure and was not part of the multiple testing procedure for statistical significance.||0.5|-0.8|0.6771
72601469|NCT02171429|144731871|SUPERIORITY||Mean Difference (Net)|-0.5||||1|TWO_SIDED|95.0|-1.0|0.0||p-value has been adjusted for multiplicity.|Mixed Model for Repeated Measures|Model adjusted for treatment, visit, stratification factors, treatment-by-visit, baseline UC-PRO/SS domain, and baseline UC-PRO/SS domain-by-visit.|Mean difference was calculated as etrolizumab arm minus placebo arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. This comparison was part of Family 4 of the testing procedure; please refer to the statistical analysis plan for details.||0.0|-1.0|1
72601470|NCT02171429|144731871|SUPERIORITY||Mean Difference (Net)|-0.3||||1|TWO_SIDED|95.0|-0.7|0.1||p-value has been adjusted for multiplicity.|Mixed Model for Repeated Measures|Model adjusted for treatment, visit, stratification factors, treatment-by-visit, baseline UC-PRO/SS domain, and baseline UC-PRO/SS domain-by-visit.|Mean difference was calculated as etrolizumab arm minus adalimumab arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. This comparison was part of Family 6 of the testing procedure; please refer to the statistical analysis plan for details.||0.1|-0.7|1
72601471|NCT02171429|144731872|SUPERIORITY||Difference in Remission Rates|7.9||||0.1382|TWO_SIDED|95.0|-3.19|16.87||Nominal p-value; it has not been adjusted for multiplicity.|Cochran-Mantel-Haenszel|Difference and 95% CI adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL) and MCS (≤9 or ≥10) at BL.|Difference in remission rates was calculated as the etrolizumab arm minus the placebo arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. Please refer to the statistical analysis plan for details. This comparison was not considered a key secondary outcome measure and was not part of the multiple testing procedure for statistical significance.||16.87|-3.19|0.1382
72601472|NCT02171429|144731872|SUPERIORITY||Difference in Remission Rates|-7.5||||0.1163|TWO_SIDED|95.0|-17.1|2.22||Nominal p-value; it has not been adjusted for multiplicity.|Cochran-Mantel-Haenszel|Difference and 95% CI adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL) and MCS (≤9 or ≥10) at BL.|Difference in remission rates was calculated as the etrolizumab arm minus the adalimumab arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. Please refer to the statistical analysis plan for details. This comparison was not considered a key secondary outcome measure and was not part of the multiple testing procedure for statistical significance.||2.22|-17.10|0.1163
72601473|NCT02171429|144731873|SUPERIORITY||Difference in Remission Rates|2.9||||0.4772|TWO_SIDED|95.0|-6.47|10.14||Nominal p-value; it has not been adjusted for multiplicity.|Cochran-Mantel-Haenszel|Difference and 95% CI adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL) and MCS (≤9 or ≥10) at BL.|Difference in remission rates was calculated as the etrolizumab arm minus the placebo arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. Please refer to the statistical analysis plan for details. This comparison was not considered a key secondary outcome measure and was not part of the multiple testing procedure for statistical significance.||10.14|-6.47|0.4772
72416221|NCT01972841|144343295|SUPERIORITY||Least squares mean difference|-0.56|STANDARD_ERROR_OF_MEAN|0.14|<|0.001|TWO_SIDED|95.0|-0.84|-0.28||Nominal p-value|ANCOVA|No adjustment for multiplicity was needed for testing combination therapy vs. its 2 monotherapy components.|Adjustment for multiplicity across primary and the first secondary endpoint as well as across the 2 combination doses was made using a sequential Bonferroni-based testing procedure.|Difference of the adjusted mean calculated by subtracting the adjusted mean of the mirabegron 50 mg monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous overactive bladder medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||-0.28|-0.84|<0.001
72416222|NCT01972841|144343296|SUPERIORITY||Least squares mean difference|3.85|STANDARD_ERROR_OF_MEAN|3.13||0.219|TWO_SIDED|95.0|-2.29|10.0||Nominal p-value|ANCOVA|No adjustment for multiplicity was needed for testing combination therapy vs. its 2 monotherapy components.|Adjustment for multiplicity across primary and the first secondary endpoint as well as across the 2 combination doses was made using a sequential Bonferroni-based testing procedure.|Difference of the adjusted mean calculated by subtracting the adjusted mean of the solifenacin 5 mg monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous overactive bladder medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||10.00|-2.29|0.219
72416223|NCT01972841|144343296|SUPERIORITY||Least squares mean difference|8.75|STANDARD_ERROR_OF_MEAN|3.13||0.005|TWO_SIDED|95.0|2.61|14.89||Nominal p-value|ANCOVA|No adjustment for multiplicity was needed for testing combination therapy vs. its 2 monotherapy components.|Adjustment for multiplicity across primary and the first secondary endpoint as well as across the 2 combination doses was made using a sequential Bonferroni-based testing procedure.|Difference of the adjusted mean calculated by subtracting the adjusted mean of the solifenacin 5 mg monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous overactive bladder medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||14.89|2.61|0.005
72416224|NCT01972841|144343296|SUPERIORITY||Least squares mean difference|21.52|STANDARD_ERROR_OF_MEAN|3.14|<|0.001|TWO_SIDED|95.0|15.35|27.68||Nominal p-value|ANCOVA|No adjustment for multiplicity was needed for testing combination therapy vs. its 2 monotherapy components.|Adjustment for multiplicity across primary and the first secondary endpoint as well as across the 2 combination doses was made using a sequential Bonferroni-based testing procedure.|Difference of the adjusted mean calculated by subtracting the adjusted mean of the mirabegron 25 mg monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous overactive bladder medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||27.68|15.35|<0.001
72601474|NCT02171429|144731873|SUPERIORITY||Difference in Remission Rates|-5.2||||0.1801|TWO_SIDED|95.0|-12.95|2.63||Nominal p-value; it has not been adjusted for multiplicity.|Cochran-Mantel-Haenszel|Difference and 95% CI adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL) and MCS (≤9 or ≥10) at BL.|Difference in remission rates was calculated as the etrolizumab arm minus the adalimumab arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. Please refer to the statistical analysis plan for details. This comparison was not considered a key secondary outcome measure and was not part of the multiple testing procedure for statistical significance.||2.63|-12.95|0.1801
72601475|NCT02171429|144731874|SUPERIORITY||Difference in Adjusted Means|4.0||||0.4833|TWO_SIDED|95.0|-7.2|15.2||Nominal p-value; it has not been adjusted for multiplicity.|ANCOVA|Model adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL), MCS (≤9 or ≥10) at BL, and IBDQ score at BL.|Mean difference was calculated as etrolizumab arm minus placebo arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. Please refer to the statistical analysis plan for details. This comparison was not considered a key secondary outcome measure and was not part of the multiple testing procedure for statistical significance.||15.2|-7.2|0.4833
72601476|NCT02171429|144731874|SUPERIORITY||Difference in Adjusted Means|0.0||||0.9931|TWO_SIDED|95.0|-9.2|9.1||Nominal p-value; it has not been adjusted for multiplicity.|ANCOVA|Model adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL), MCS (≤9 or ≥10) at BL, and IBDQ score at BL.|Mean difference was calculated as etrolizumab arm minus adalimumab arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. Please refer to the statistical analysis plan for details. This comparison was not considered a key secondary outcome measure and was not part of the multiple testing procedure for statistical significance.||9.1|-9.2|0.9931
72601477|NCT04957212|144731881|EQUIVALENCE|We used an equivalence margin of 0.2 for the primary endpoint.|Risk Difference (RD)|-0.04||||0.54|TWO_SIDED|95.0|-0.16|0.09|||Chi-squared|||||0.09|-0.16|0.54
72601478|NCT04957212|144731882|OTHER||Risk Difference (RD)|-0.07||||0.26|TWO_SIDED|95.0|-0.21|0.06|||Chi-squared|||||0.06|-0.21|0.26
72601479|NCT04957212|144731883|OTHER|||||||0.99|||||||Fisher Exact|||||||0.99
72601480|NCT04957212|144731884|OTHER|||||||0.56|||||||Chi-squared|||||||0.56
72601481|NCT01768559|144731918|NON_INFERIORITY_OR_EQUIVALENCE|Pre-specified non-inferiority margin of 0.4%.|Least Square (LS) Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.059|||TWO_SIDED|95.0|-0.17|0.064|||ANCOVA||Lixisenatide vs Insulin Glulisine QD|Analysis was performed using analysis of covariance (ANCOVA) model with treatment groups, strata of Week -1 HbA1c (\<8.0, ≥8.0%), randomization strata of metformin use, and country as fixed effects and baseline HbA1c value as a covariate. The non-inferiority was assessed using upper bound of 2-sided 95% Confidence Interval (CI).||0.064|-0.17|
72601482|NCT01768559|144731918|NON_INFERIORITY_OR_EQUIVALENCE|Pre-specified non-inferiority margin of 0.4%.|LS Mean Difference|0.21|STANDARD_ERROR_OF_MEAN|0.059|||TWO_SIDED|95.0|0.095|0.328|||ANCOVA||Lixisenatide vs Insulin Glulisine TID|Analysis was performed using ANCOVA model as described above. Hochberg procedure was used to control type 1 error at significance level = 0.025 (1-sided) for comparison between Lixisenatide vs Insulin glulisine TID in HbA1c and body weight. If both comparisons were met, then both would be declared significant. Otherwise, if only one was met, then the one met should be tested at α=0.0125 (1-sided).||0.328|0.095|
72601483|NCT01768559|144731919|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.99|STANDARD_ERROR_OF_MEAN|0.305|<|0.0001|TWO_SIDED|95.0|-2.593|-1.396||Threshold for significance at 0.025 level.|ANCOVA|The superiority was assessed by comparing the P-value at significance level = 0.025 or 0.0125.|Lixisenatide vs Insulin Glulisine TID|Analysis was performed using ANCOVA model as described above. Hochberg procedure was used to control type 1 error at α = 0.025 (1-sided) for comparison between lixisenatide vs insulin glulisine TID in HbA1c and body weight. If both comparisons were met, then both would be declared significant. Otherwise, if only one was met, then the one met should be tested at α=0.0125 (1-sided).||-1.396|-2.593|< 0.0001
72601484|NCT01515696|144731939|SUPERIORITY_OR_OTHER||Median Difference (Net)|1.0||||0.61||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.61
72601485|NCT01515696|144731940|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|7.5||||0.05||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.05
72601486|NCT01515696|144731941|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Chi-squared|||||||>0.05
72601487|NCT01188668|144731949|SUPERIORITY_OR_OTHER||ratio of adjusted means|105.97|||||TWO_SIDED|90.0|101.39|110.76|||||Values have been back-transformed from the log scale.|DVS SR 100 mg + Aripiprazole 5 mg (test) versus Aripiprazole 5 mg (reference)||110.76|101.39|
72601488|NCT01188668|144731950|SUPERIORITY_OR_OTHER||ratio of adjusted means|101.05|||||TWO_SIDED|90.0|92.94|109.87|||||Values have been back-transformed from the log scale.|DVS SR 100 mg + Aripiprazole 5 mg (test) versus Aripiprazole 5 mg (reference)||109.87|92.94|
72601489|NCT01188668|144731955|SUPERIORITY_OR_OTHER||ratio of adjusted means|102.93|||||TWO_SIDED|90.0|94.21|112.46|||||Values have been back-transformed from the log scale.|DVS SR 100 mg + Aripiprazole 5 mg (test) versus Aripiprazole 5 mg (reference)||112.46|94.21|
72601490|NCT01188668|144731956|SUPERIORITY_OR_OTHER||ratio of adjusted means|106.27|||||TWO_SIDED|90.0|100.97|111.85|||||Values have been back-transformed from the log scale.|DVS SR 100 mg + Aripiprazole 5 mg (test) versus Aripiprazole 5 mg (reference)||111.85|100.97|
72601491|NCT02081001|144731965|SUPERIORITY_OR_OTHER||Point estimate ratio|2.06|STANDARD_ERROR_OF_MEAN|1.19||0.23|TWO_SIDED|90.0|0.74|5.75|||Mixed Models Analysis|||||5.75|0.74|0.23
72601492|NCT02081001|144731965|SUPERIORITY_OR_OTHER||Point estimate ratio|1.25|STANDARD_ERROR_OF_MEAN|0.43||0.52|TWO_SIDED|90.0|0.69|2.28|||Mixed Models Analysis|||||2.28|0.69|0.52
72601493|NCT02081001|144731965|SUPERIORITY_OR_OTHER||Point estimate ratio|0.86|STANDARD_ERROR_OF_MEAN|0.19||0.49|TWO_SIDED|90.0|0.59|1.25|||Mixed Models Analysis|||||1.25|0.59|0.49
72601494|NCT02081001|144731966|SUPERIORITY_OR_OTHER||Point estimate ratio|1.37|STANDARD_ERROR_OF_MEAN|0.34||0.23|TWO_SIDED|90.0|0.88|2.12|||Mixed Models Analysis|||||2.12|0.88|0.23
72601495|NCT02081001|144731966|SUPERIORITY_OR_OTHER||Point estimate ratio|1.29|STANDARD_ERROR_OF_MEAN|0.18||0.09|TWO_SIDED|90.0|1.01|1.65|||Mixed Models Analysis|||||1.65|1.01|0.09
72601496|NCT02081001|144731966|SUPERIORITY_OR_OTHER||Point estimate ratio|1.36|STANDARD_ERROR_OF_MEAN|0.16||0.02|TWO_SIDED|90.0|1.11|1.67|||Mixed Models Analysis|||||1.67|1.11|0.02
72601497|NCT02081001|144731967|SUPERIORITY_OR_OTHER||Point estimate ratio|1.26|STANDARD_ERROR_OF_MEAN|0.19||0.15|TWO_SIDED|90.0|0.97|1.64|||Mixed Models Analysis|||||1.64|0.97|0.15
72601498|NCT02081001|144731967|SUPERIORITY_OR_OTHER||Point estimate ratio|1.29|STANDARD_ERROR_OF_MEAN|0.26||0.24|TWO_SIDED|90.0|0.9|1.84|||Mixed Models Analysis|||||1.84|0.90|0.24
72601499|NCT02081001|144731967|SUPERIORITY_OR_OTHER||Point estimate ratio|0.83|STANDARD_ERROR_OF_MEAN|0.15||0.31|TWO_SIDED|90.0|0.6|1.14|||Mixed Models Analysis|||||1.14|0.60|0.31
72601500|NCT02081001|144731968|SUPERIORITY_OR_OTHER||Point estimate ratio|1.18|STANDARD_ERROR_OF_MEAN|0.11||0.09|TWO_SIDED|90.0|1.01|1.39|||Mixed Models Analysis|||||1.39|1.01|0.09
72601501|NCT02081001|144731968|SUPERIORITY_OR_OTHER||Point estimate ratio|1.12|STANDARD_ERROR_OF_MEAN|0.12||0.29|TWO_SIDED|90.0|0.93|1.35|||Mixed Models Analysis|||||1.35|0.93|0.29
72601502|NCT02081001|144731968|SUPERIORITY_OR_OTHER||Point estimate ratio|1.11|STANDARD_ERROR_OF_MEAN|0.09||0.24|TWO_SIDED|90.0|0.96|1.28|||Mixed Models Analysis|||||1.28|0.96|0.24
72601503|NCT02081001|144731969|SUPERIORITY_OR_OTHER||Point estimate ratio|0.91|STANDARD_ERROR_OF_MEAN|0.22||0.7|TWO_SIDED|90.0|0.6|1.38|||Mixed Models Analysis|||||1.38|0.60|0.70
72601504|NCT02081001|144731969|SUPERIORITY_OR_OTHER||Point estimate ratio|1.26|STANDARD_ERROR_OF_MEAN|0.21||0.19|TWO_SIDED|90.0|0.94|1.68|||Mixed Models Analysis|||||1.68|0.94|0.19
72601505|NCT02081001|144731969|SUPERIORITY_OR_OTHER||Point estmate ratio|1.45|STANDARD_ERROR_OF_MEAN|0.26||0.052|TWO_SIDED|90.0|1.07|1.98|||Mixed Models Analysis|||||1.98|1.07|0.052
72601506|NCT02081001|144731970|SUPERIORITY_OR_OTHER||Point estimate ratio|2.02|STANDARD_ERROR_OF_MEAN|0.95||0.16|TWO_SIDED|90.0|0.87|4.66|||Mixed Models Analysis|||||4.66|0.87|0.16
72601507|NCT02081001|144731970|SUPERIORITY_OR_OTHER||Point estimate ratio|1.31|STANDARD_ERROR_OF_MEAN|0.49||0.48|TWO_SIDED|90.0|0.68|2.54|||Mixed Models Analysis|||||2.54|0.68|0.48
72601508|NCT02081001|144731970|SUPERIORITY_OR_OTHER||Point estimate ratio|0.8|STANDARD_ERROR_OF_MEAN|0.16||0.28|TWO_SIDED|90.0|0.57|1.13|||Mixed Models Analysis|||||1.13|0.57|0.28
72601509|NCT02081001|144731971|SUPERIORITY_OR_OTHER||Point estimate ratio|1.06|STANDARD_ERROR_OF_MEAN|0.12||0.61|TWO_SIDED|90.0|0.87|1.3|||Mixed Models Analysis|||||1.30|0.87|0.61
72601510|NCT02081001|144731971|SUPERIORITY_OR_OTHER||Point estimate ratio|1.19|STANDARD_ERROR_OF_MEAN|0.16||0.22|TWO_SIDED|90.0|0.94|1.5|||Mixed Models Analysis|||||1.5|0.94|0.22
72601511|NCT02081001|144731971|SUPERIORITY_OR_OTHER||Point estimate ratio|0.84|STANDARD_ERROR_OF_MEAN|0.12||0.26|TWO_SIDED|90.0|0.66|1.09|||Mixed Models Analysis|||||1.09|0.66|0.26
72601512|NCT02081001|144731972|SUPERIORITY_OR_OTHER||Point estimate ratio|1.18|STANDARD_ERROR_OF_MEAN|0.14||0.19|TWO_SIDED|90.0|0.96|1.46|||Mixed Models Analysis|||||1.46|0.96|0.19
72601513|NCT02081001|144731972|SUPERIORITY_OR_OTHER||Point estimate ratio|1.15|STANDARD_ERROR_OF_MEAN|0.12||0.21|TWO_SIDED|90.0|0.95|1.38|||Regression, Cox|||||1.38|0.95|0.21
72601514|NCT02081001|144731972|SUPERIORITY_OR_OTHER||Point estimate ratio|1.13|STANDARD_ERROR_OF_MEAN|0.1||0.19|TWO_SIDED|90.0|0.97|1.31|||Mixed Models Analysis|||||1.31|0.97|0.19
72601515|NCT02081001|144731973|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.4|STANDARD_ERROR_OF_MEAN|5.4||0.24|TWO_SIDED|95.0|-17.1|4.3|||Mixed Models Analysis|||||4.3|-17.1|0.24
72601516|NCT02081001|144731973|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.4|STANDARD_ERROR_OF_MEAN|5.4||0.0005|TWO_SIDED|95.0|-30.1|-8.7|||Mixed Models Analysis|||||-8.7|-30.1|0.0005
72601517|NCT02081001|144731973|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-23.3|STANDARD_ERROR_OF_MEAN|5.4|<|0.0001|TWO_SIDED|95.0|-34.0|-12.6|||Mixed Models Analysis|||||-12.6|-34.0|<0.0001
72601518|NCT02081001|144731974|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.0|STANDARD_ERROR_OF_MEAN|1.6||0.22|TWO_SIDED|95.0|-5.1|1.2|||Mixed Models Analysis|||||1.2|-5.1|0.22
72601519|NCT02081001|144731974|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.9|STANDARD_ERROR_OF_MEAN|1.6||0.58|TWO_SIDED|95.0|-4.0|2.3|||Mixed Models Analysis|||||2.3|-4.0|0.58
72601520|NCT02081001|144731974|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.6|STANDARD_ERROR_OF_MEAN|1.6||0.03|TWO_SIDED|95.0|-6.7|-0.4|||Mixed Models Analysis|||||-0.4|-6.7|0.03
72601521|NCT05816070|144731982|NON_INFERIORITY|The non-inferiority margin is -10% based on the general standard of antibacterial drug. Non-inferiority is established when P\<0.05.||||||0.0137|||||||Chi-squared|||||||0.0137
72601522|NCT00423813|144732045|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||Chi-squared|||Overall Comparison||||0.001
72601523|NCT00423813|144732045|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||Pairwise comparison of Xyrem 4.5g and placebo||||<0.001
72601524|NCT00423813|144732045|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||Chi-squared|||Pairwise comparison of Xyrem 6.0g and placebo||||0.001
72601525|NCT01386944|144732054|SUPERIORITY_OR_OTHER||Hodges-Lehmann Estimate|-0.5|||||TWO_SIDED|95.0|-1.0|-0.5||||||||-0.5|-1.0|
72601526|NCT01386944|144732055|SUPERIORITY_OR_OTHER||Hodges-Lehmann Estimate|-1.5|||||TWO_SIDED|95.0|-1.5|-1.0||||||||-1.0|-1.5|
72601527|NCT01386944|144732056|SUPERIORITY_OR_OTHER||Hodges-Lehmann Estimate|-2.0||||||95.0|-2.0|-1.5||||||||-1.5|-2.0|
72601528|NCT01386944|144732057|SUPERIORITY_OR_OTHER||Hodges-Lehmann Estimate|-2.0||||||95.0|-2.5|-1.5||||||||-1.5|-2.5|
72601529|NCT01386944|144732058|SUPERIORITY_OR_OTHER||Hodges-Lehmann Estimate|-2.0||||||95.0|-2.5|-1.5||||||||-1.5|-2.5|
72601530|NCT01386944|144732059|SUPERIORITY_OR_OTHER||Hodges-Lehmann Estimate|-2.0||||||95.0|-2.0|-1.5||||||||-1.5|-2.0|
72601531|NCT03883477|144732061|OTHER|The trial was powered to detect a difference in POSAS score of 10, deemed to be clinically significant by the investigators. To detect a mean difference in POSAS score of 10 points (SD = 8) with a two-sided significance level of 5% and power of 80% with equal allocation to two arms required 12 patients in each arm of the trial.||||||0.013||||||1 week P-value|Wilcoxon (Mann-Whitney)|||||||0.013
72416225|NCT01972841|144343296|SUPERIORITY||Least squares mean difference|17.74|STANDARD_ERROR_OF_MEAN|3.14|<|0.001|TWO_SIDED|95.0|11.58|23.9||Nominal p-value|ANCOVA|No adjustment for multiplicity was needed for testing combination therapy vs. its 2 monotherapy components.|Adjustment for multiplicity across primary and the first secondary endpoint as well as across the 2 combination doses was made using a sequential Bonferroni-based testing procedure.|Difference of the adjusted mean calculated by subtracting the adjusted mean of the mirabegron 50 mg monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous overactive bladder medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||23.90|11.58|<0.001
72416226|NCT01972841|144343297|SUPERIORITY||Least squares mean difference|-4.63|STANDARD_ERROR_OF_MEAN|1.2|<|0.001|TWO_SIDED|95.0|-6.98|-2.27|||ANCOVA|No adjustment for multiplicity was made for this comparison.||Difference of the adjusted mean calculated by subtracting the adjusted mean of the solifenacin 5 mg monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous overactive bladder medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||-2.27|-6.98|<0.001
72421630|NCT03720938|144354390|SUPERIORITY|||||||0.002||||||The outcome of self-perception for sports competence was tested for any difference between groups by linear mixed-effects model analysis.|Linear mixed effects model|Adjusted by Satterthwaite's degrees of freedom method for cluster effect, and small sample sizes in addition to baseline value and age.||Null hypothesis was the absence of difference between the two groups for the dependent variable self-perception of global self-worth.||||0.002
72601532|NCT03883477|144732061|OTHER|||||||0.007||||||1 month P-value|Wilcoxon (Mann-Whitney)|||The trial was powered to detect a difference in POSAS score of 10, deemed to be clinically significant by the investigators. To detect a mean difference in POSAS score of 10 points (SD = 8) with a two-sided significance level of 5% and power of 80% with equal allocation to two arms required 12 patients in each arm of the trial.||||0.007
72601533|NCT03883477|144732061|OTHER|||||||0.804||||||6 month P-value|Wilcoxon (Mann-Whitney)|||The trial was powered to detect a difference in POSAS score of 10, deemed to be clinically significant by the investigators. To detect a mean difference in POSAS score of 10 points (SD = 8) with a two-sided significance level of 5% and power of 80% with equal allocation to two arms required 12 patients in each arm of the trial.||||0.804
72601534|NCT03883477|144732062|OTHER|||||||0.142|||||||Wilcoxon (Mann-Whitney)|||||||0.142
72601535|NCT03883477|144732063|OTHER|||||||0.561|||||||Wilcoxon (Mann-Whitney)|||||||0.561
72601536|NCT03883477|144732064|OTHER|||||||0.748|||||||Wilcoxon (Mann-Whitney)|||||||0.748
72601537|NCT03883477|144732065|OTHER|||||||0.184|||||||Wilcoxon (Mann-Whitney)|||||||0.184
72601538|NCT03883477|144732066|OTHER|||||||0.382|||||||Chi-squared|||||||0.382
72601539|NCT03883477|144732067|OTHER|||||||0.382|||||||Chi-squared|||||||0.382
72601540|NCT00492232|144732082|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|0.71||||0.484||95.0|0.27|1.85||Statistical significance was determined at the 0.05 level.|Regression, Logistic|Log odds of achieving response were estimated using the logistic regression analysis adjusted for effects of treatment and pooled center.||||1.85|0.27|0.484
72601541|NCT00492232|144732083|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2||||0.946||95.0|-6.23|5.81||P-values are from t-tests of the analysis of covariance (ANCOVA) model for the difference in least squares (LS) means between treatments. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from an ANCOVA model with baseline zolpidem dosage (≤10 mg vs \>10 mg) and pooled center as covariates.||||5.81|-6.23|0.946
72601542|NCT00492232|144732084|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.4||||0.901||95.0|-5.31|6.03||P-values are from t-tests of the ANCOVA model for the difference in LS means between treatments. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from an ANCOVA model with baseline zolpidem dosage (≤10 mg vs \>10 mg) and pooled center as covariates.||||6.03|-5.31|0.901
72601543|NCT00492232|144732085|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.0||||0.538||95.0|-4.32|8.23||P-values are from t-tests of the ANCOVA model for the difference in LS means between treatments. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from an ANCOVA model with baseline zolpidem dosage (≤10 mg vs \>10 mg) and pooled center as covariates.||||8.23|-4.32|0.538
72601544|NCT00492232|144732086|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.2||||0.517||95.0|-9.09|4.6||P-values are from t-tests of the ANCOVA model for the difference in LS means between treatments. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from an ANCOVA model with baseline zolpidem dosage (≤10 mg vs \>10 mg) and pooled center as covariates.||||4.60|-9.09|0.517
72601545|NCT00492232|144732087|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||0.965||95.0|-6.28|6.56||P-values are from t-tests of the ANCOVA model for the difference in LS means between treatments. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from an ANCOVA model with baseline zolpidem dosage (≤10 mg vs \>10 mg) and pooled center as covariates.||||6.56|-6.28|0.965
72601546|NCT00492232|144732088|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.09||||0.617||95.0|-0.27|0.45||P-values are from t-tests of the ANCOVA model for the difference in LS means between treatments. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from an ANCOVA model with baseline zolpidem dosage (≤10 mg vs \>10 mg), baseline zolpidem frequency, and pooled center as covariates.||||0.45|-0.27|0.617
72601547|NCT00492232|144732089|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.17||||0.541||95.0|-0.39|0.74||P-values are from t-tests of the ANCOVA model for the difference in LS means between treatments. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from an ANCOVA model with baseline zolpidem dosage (≤10 mg vs \>10 mg), baseline zolpidem frequency, and pooled center as covariates.||||0.74|-0.39|0.541
72601548|NCT00492232|144732090|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.55||||0.163||95.0|-0.23|1.33||P-values are from t-tests of the ANCOVA model for the difference in LS means between treatments. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from an ANCOVA model with baseline zolpidem dosage (≤10 mg vs \>10 mg), baseline zolpidem frequency, and pooled center as covariates.||||1.33|-0.23|0.163
72601549|NCT00492232|144732091|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.15||||0.757||95.0|-0.79|1.08||P-values are from t-tests of the ANCOVA model for the difference in LS means between treatments. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from an ANCOVA model with baseline zolpidem dosage (≤10 mg vs \>10 mg), baseline zolpidem frequency, and pooled center as covariates.||||1.08|-0.79|0.757
72601550|NCT00492232|144732092|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.12||||0.82||95.0|-0.93|1.17||P-values are from t-tests of the ANCOVA model for the difference in LS means between treatments. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from an ANCOVA model with baseline zolpidem dosage (≤10 mg vs \>10 mg), baseline zolpidem frequency, and pooled center as covariates.||||1.17|-0.93|0.820
72601551|NCT00492232|144732094|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|2.01||||0.284||95.0|0.55|7.34||P-values are from Chi-square tests of the log-regression model for the overall treatment comparison. Statistical significance was determined at the 0.05 level.|Regression, Logistic|Log odds of achieving response were estimated using logistic regression analysis adjusted for effects of baseline zolpidem dosage (≤10 mg vs \>10 mg).||||7.34|0.55|0.284
72601552|NCT00492232|144732095|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.42||||0.389||95.0|0.64|3.13||P-values are from Chi-square tests of the log-regression model for the overall treatment comparison. Statistical significance was determined at the 0.05 level.|Regression, Logistic|Log odds of achieving response were estimated using logistic regression analysis adjusted for effects of baseline zolpidem dosage (≤10 mg vs \>10 mg).||||3.13|0.64|0.389
72601553|NCT00636636|144732103|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.49|STANDARD_ERROR_OF_MEAN|0.2||0.0125|TWO_SIDED|95.0|-0.88|-0.11|||ANCOVA|||||-0.11|-0.88|0.0125
72601554|NCT00636636|144732104|SUPERIORITY_OR_OTHER||Difference in proportion|0.092||||0.0434|TWO_SIDED|95.0|0.0|0.18|||Z test|||P-value (vs Placebo) for pairwise test of treatment effect between G-ER group and Placebo group is based on Z test for difference between the 2 groups in proportion of participants who were categorized as very much or much improved in PGIC at endpoint. Proportion in each group calculated from number of participants categorized as very much or much improved relative to total number of participants in ITT population.||0.18|-0.00|0.0434
72601555|NCT00636636|144732105|SUPERIORITY_OR_OTHER||Difference in proportion|0.102||||0.0268|TWO_SIDED|95.0|0.01|0.19|||Z test|||P-value (vs Placebo) for pairwise test of treatment effect between G-ER group and Placebo group is based on Z test for difference between the 2 groups in proportion of participants who were categorized as very much or much improved in CGIC at endpoint. Proportion in each group calculated from number of participants categorized as very much or much improved relative to total number of participants in ITT population.||0.19|0.01|0.0268
72601556|NCT00636636|144732106|SUPERIORITY_OR_OTHER||Least square mean difference|-0.71|STANDARD_ERROR_OF_MEAN|0.18||0.0001|TWO_SIDED|95.0|-1.07|-0.35|||ANCOVA||P-value versus Placebo for pairwise test of difference of LS mean change from baseline between G-ER and Placebo groups is based on t-test of Type III analysis.|||-0.35|-1.07|0.0001
72601557|NCT00636636|144732107|SUPERIORITY_OR_OTHER||Least square mean difference|-0.55|STANDARD_ERROR_OF_MEAN|0.2||0.007|TWO_SIDED|95.0|-0.96|-0.15|||ANCOVA|||||-0.15|-0.96|0.007
72601558|NCT04811664|144732112|SUPERIORITY||Vaccine efficacy, (1-HR) *100%|52.6|||||TWO_SIDED|95.0|-14.1|80.3|||||"Immediate Vaccination compared to Standard of care (reference). Wald 95% CI."|Cox model on the calendar time scale, stratified by site and adjusted for sex, residence, team sport participation, mask wearing and SARS-CoV-2 exposure risk score. Outside vaccination censoring.||80.3|-14.1|
72601559|NCT04811664|144732115|SUPERIORITY||Vaccine efficacy, (1-HR) *100%|71.0|||||TWO_SIDED|95.0|-9.5|92.3|||||"Immediate Vaccination compared to Standard of care (reference). Wald 95% CI."|Cox model on the calendar time scale, stratified by site and adjusted for sex, residence, team sport participation, mask wearing and SARS-CoV-2 exposure risk score. Outside vaccination censoring.||92.3|-9.5|
72601560|NCT04811664|144732116|SUPERIORITY||Vaccine efficacy, (1-HR) *100%|41.2|||||TWO_SIDED|95.0|-37.7|74.9|||||"Immediate Vaccination compared to Standard of care (reference). Wald 95% CI."|Cox model on the calendar time scale, stratified by site and adjusted for sex, residence, team sport participation, mask wearing and SARS-CoV-2 exposure risk score. Outside vaccination censoring.||74.9|-37.7|
72601561|NCT02526160|144732130|SUPERIORITY||||||<|0.0001||||||From Cochran-Mantel-Haenszel (CMH) testing for association between achieving mean serum phosphorus levels above lower limit of normal (LLN) and treatment group, adjusting for stratification of Brief Pain Inventory (BPI) Average Pain and region.|Cochran-Mantel-Haenszel|||||||< 0.0001
72601562|NCT02526160|144732131|SUPERIORITY||Least squares (LS) mean difference|-0.46|STANDARD_ERROR_OF_MEAN|0.275||0.0919|TWO_SIDED|95.0|-1.0|0.08||Prespecified significance level for test after Hochberg adjustment: 0.05|GEE model|||||0.08|-1.00|0.0919
72601563|NCT02526160|144732132|SUPERIORITY||LS mean difference|-8.31|STANDARD_ERROR_OF_MEAN|3.251||0.0106|TWO_SIDED|95.0|-14.68|-1.94||Prespecified significance level for test after Hochberg adjustment: 0.0167|GEE model|||||-1.94|-14.68|0.0106
72601564|NCT02526160|144732133|SUPERIORITY||LS mean difference|-4.9|STANDARD_ERROR_OF_MEAN|2.479||0.0478|TWO_SIDED|95.0|-9.76|-0.05||Prespecified significance level for test after Hochberg adjustment: 0.025|GEE model|||||-0.05|-9.76|0.0478
72601565|NCT00136214|144732164|SUPERIORITY|||||||0.08|||||||Wilcoxon (Mann-Whitney)|||Within group comparison of IFN group for metabolites in basal ganglia Comparison on MR spectroscopy of Cho/Cr at time points 1,2 and 3||||0.08
72601566|NCT00136214|144732164|SUPERIORITY|||||||0.3|||||||Wilcoxon (Mann-Whitney)|||Within group comparison of IFN group for metabolites in basal ganglia Comparison on MR spectroscopy of Mi/Cr at time points 1,2 and 3||||0.3
72601567|NCT00136214|144732164|SUPERIORITY|||||||0.9|||||||Wilcoxon (Mann-Whitney)|||Within group comparison of IFN group for metabolites in basal ganglia Comparison on MR spectroscopy of NAA/Cr at time points 1,2 and 3||||0.9
72601568|NCT00136214|144732164|SUPERIORITY|||||||0.7|||||||Wilcoxon (Mann-Whitney)|||Within group comparison of IFN group for metabolites in frontal cortex. Comparison on MR spectroscopy of Cho/Cr at time points 1,2 and 3||||0.7
72601569|NCT00136214|144732164|SUPERIORITY|||||||0.4|||||||Wilcoxon (Mann-Whitney)|||Within group comparison of IFN group for metabolites in frontal cortex. Comparison on MR spectroscopy of MI/Cr at time points 1,2 and 3||||0.4
72601570|NCT00136214|144732164|SUPERIORITY|||||||0.6|||||||Wilcoxon (Mann-Whitney)|||Within group comparison of IFN group for metabolites in frontal cortex. Comparison on MR spectroscopy of NAA/Cr at time points 1,2 and 3||||0.6
72601571|NCT00136214|144732164|SUPERIORITY|||||||0.3|||||||Wilcoxon (Mann-Whitney)|||Within group comparison of IFN group for metabolites in DLPFC. Comparison on MR spectroscopy of Cho/Cr at time points 1,2 and 3||||0.3
72601572|NCT00136214|144732164|SUPERIORITY|||||||0.3|||||||Wilcoxon (Mann-Whitney)|||Within group comparison of IFN group for metabolites in DLPFC. Comparison on MR spectroscopy ofMI/Cr at time points 1,2 and 3||||0.3
72601573|NCT00136214|144732164|SUPERIORITY|||||||0.3|||||||Wilcoxon (Mann-Whitney)|||Within group comparison of IFN group for metabolites in DLPFC. Comparison on MR spectroscopy of NAA/Cr at time points 1,2 and 3||||0.3
72601574|NCT00136214|144732164|SUPERIORITY|||||||0.4|||||||Wilcoxon (Mann-Whitney)|||Within group comparison of control group for metabolites in Basal ganglia. Comparison on MR spectroscopy of Cho/Cr at time points 1 and 2||||0.4
72601575|NCT00136214|144732164|SUPERIORITY|||||||0.9|||||||Wilcoxon (Mann-Whitney)|||Within group comparison of control group for metabolites in Basal ganglia. Comparison on MR spectroscopy of MI/Cr at time points 1 and 2||||0.9
72601576|NCT00136214|144732164|SUPERIORITY|||||||0.6|||||||Wilcoxon (Mann-Whitney)|||Within group comparison of control group for metabolites in Basal ganglia. Comparison on MR spectroscopy of NAA/Cr at time points 1 and 2||||0.6
72601577|NCT00136214|144732164|SUPERIORITY|||||||0.7|||||||Wilcoxon (Mann-Whitney)|||Within group comparison of control group for metabolites in frontal cortex. Comparison on MR spectroscopy of Cho/Cr at time points 1 and 2||||0.7
72601578|NCT00136214|144732164|SUPERIORITY|||||||0.1|||||||Wilcoxon (Mann-Whitney)|||Within group comparison of control group for metabolites in frontal cortex. Comparison on MR spectroscopy of MI/Cr at time points 1 and 2||||0.1
72601579|NCT00136214|144732164|SUPERIORITY|||||||0.6|||||||Wilcoxon (Mann-Whitney)|||Within group comparison of control group for metabolites in frontal cortex. Comparison on MR spectroscopy of NAA/Cr at time points 1 and 2||||0.6
72601580|NCT00136214|144732164|SUPERIORITY|||||||0.5|||||||Wilcoxon (Mann-Whitney)|||Within group comparison of control group for metabolites in DLPFC. Comparison on MR spectroscopy of Cho/Cr at time points 1 and 2||||0.5
72601581|NCT00136214|144732164|SUPERIORITY|||||||0.4|||||||Wilcoxon (Mann-Whitney)|||Within group comparison of control group for metabolites in DLPFC. Comparison on MR spectroscopy of MI/Cr at time points 1 and 2||||0.4
72601582|NCT00136214|144732164|SUPERIORITY|||||||0.9|||||||Wilcoxon (Mann-Whitney)|||Within group comparison of control group for metabolites in DLPFC. Comparison on MR spectroscopy of NAA/Crat time points 1 and 2||||0.9
72601583|NCT00136214|144732165|SUPERIORITY||||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||Comparison between controls and IFN treated at time point 1 on change between scores for HVLT||||>0.05
72601584|NCT00136214|144732165|SUPERIORITY||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||Comparison between controls and IFN treated at time point 1 on change between scores for ROCF||||< 0.05
72601585|NCT00136214|144732165|SUPERIORITY||||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||Comparison between controls and IFN treated at time point 2 on change between scores for HVLT||||>0.05
72601586|NCT00136214|144732165|SUPERIORITY||||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||Comparison between controls and IFN treated at time point 2 on change between scores for ROCF||||>0.05
72601587|NCT04985942|144732166|SUPERIORITY||Least Squares Mean Difference|-4.9|STANDARD_ERROR_OF_MEAN|0.75|<|0.0001|TWO_SIDED|95.0|-6.38|-3.44|||Mixed Effects Model for Repeated Measure|MMRM Analysis Based on Hypothetical Estimand Strategy||||-3.44|-6.38|<0.0001
72601588|NCT04985942|144732167|SUPERIORITY||Least Squares Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001|TWO_SIDED|95.0|-0.85|-0.48|||Mixed Effects Model for Repeated Measure|MMRM Analysis Based on Hypothetical Estimand Strategy||||-0.48|-0.85|<0.0001
72601589|NCT02849704|144732214|SUPERIORITY||||||<|0.001||||||a priori threshold for significance: \<0.05|t-test, 2 sided|||||||<0.001
72601590|NCT02849704|144732215|SUPERIORITY||||||>|0.05||||||a priori threshold for statistical significance \<0.05|t-test, 2 sided|||||||>0.05
72601591|NCT02849704|144732216|SUPERIORITY||||||<|0.01||||||a priori threshold for statistical significance \<0.05|t-test, 2 sided|||||||<0.01
72601592|NCT02849704|144732217|SUPERIORITY||||||>|0.05||||||a priori threshold for statistical significance \<0.05|t-test, 2 sided|||||||>0.05
72601593|NCT02849704|144732218|SUPERIORITY||||||<|0.05||||||a priori threshold for statistical significance \<0.05|t-test, 2 sided|||||||<0.05
72416227|NCT01972841|144343297|SUPERIORITY||Least squares mean difference|-5.8|STANDARD_ERROR_OF_MEAN|1.21|<|0.001|TWO_SIDED|95.0|-8.17|-3.44|||ANCOVA|No adjustment for multiplicity was made for this comparison.||Difference of the adjusted mean calculated by subtracting the adjusted mean of the solifenacin 5 mg monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous overactive bladder medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||-3.44|-8.17|<0.001
72601594|NCT02849704|144732219|SUPERIORITY||||||>|0.05||||||a priori threshold for statistical significance \<0.05|t-test, 2 sided|||||||>0.05
72601595|NCT02576977|144732222|SUPERIORITY||Hazard Ratio (HR)|1.5||||0.99324|TWO_SIDED|95.0|1.08|2.08|||Log Rank|One-sided p-value based on Stratified log-rank test.|Based on Cox regression model with treatment as a covariate stratified by disease status (refractory vs. sensitive to Lenalidomide) and Lines of previous treatments (two vs. three or more).|||2.08|1.08|0.99324
72601596|NCT02576977|144732223|SUPERIORITY||Hazard Ratio (HR)|1.84||||0.99989|TWO_SIDED|95.0|1.32|2.55|||Log Rank|One-sided p-value based on Stratified log-rank test.|||The Hazard Ratio and 95% confidence intervals were based on Cox regression model with treatment as a covariate stratified by disease status (refractory vs. sensitive to Lenalidomide) and Lines of previous treatments (two vs. three or more).|2.55|1.32|0.99989
72601597|NCT02576977|144732224|SUPERIORITY||Difference in % vs. SOC|-5.2||||0.79921|TWO_SIDED|95.0|-17.1|6.9|||Miettinen & Nurminen method||||Based on Miettinen \& Nurminen method stratified by disease status (refractory vs. sensitive to Lenalidomide) and Lines of previous treatments (two vs. three or more); If there were no participants in one of the treatment groups involved in a comparison for a particular stratum, then that stratum was excluded from the treatment comparison.|6.9|-17.1|0.79921
72601598|NCT01128400|144732232|SUPERIORITY_OR_OTHER|||||||0.05|||||||ANOVA|||||||0.05
72601599|NCT01128400|144732233|SUPERIORITY_OR_OTHER|||||||0.05|||||||ANOVA|||||||0.05
72601600|NCT04727528|144732243|SUPERIORITY||Odds Ratio (OR)|56.2||||0.001|TWO_SIDED|95.0|5.6|563.6|||Wald Chi-Squared test||Logistic regression model included response status (response / non-response) as the dependent variable and randomized treatment as an independent factor.|||563.6|5.6|0.001
72601601|NCT04727528|144732244|SUPERIORITY||Least-squares mean|1.64|STANDARD_ERROR_OF_MEAN|0.81||0.05|TWO_SIDED|95.0|0.0|3.29|||t-test, 2 sided|||Difference between groups||3.29|-0.00|0.050
72601602|NCT04727528|144732245|SUPERIORITY||Odds Ratio (OR)|3.2||||0.153|TWO_SIDED|95.0|0.6|15.8|||Wald Chi-Squared test|||Comparison between groups||15.8|0.6|0.153
72601603|NCT04727528|144732246|SUPERIORITY||Odds Ratio (OR)|57008.6||||0.94|TWO_SIDED|95.0|0.0||The upper limit of the 95% confidence interval = 13124060000000000000000000000||Wald Chi-Squared test|||Comparison between groups|||0.0|0.940
72601604|NCT04727528|144732247|SUPERIORITY||Odds Ratio (OR)|2.2||||0.271|TWO_SIDED|95.0|0.5|8.6|||Wald Chi-Squared test|||Comparison between groups||8.6|0.5|0.271
72601605|NCT04727528|144732248|SUPERIORITY||Odds Ratio (OR)|10.8||||0.039|TWO_SIDED|95.0|1.1|102.8|||Wald Chi-Squared test|||Comparison between groups||102.8|1.1|0.039
72601606|NCT04727528|144732249|SUPERIORITY||Odds Ratio (OR)|57008.6||||0.94|TWO_SIDED|95.0|0.0||The upper limit of the 95% confidence interval = 13124060000000000000000000000||Wald Chi-Squared test|||Comparison between groups|||0.0|0.940
72601607|NCT01763827|144732255|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-57.14|STANDARD_ERROR_OF_MEAN|2.03|<|0.001|TWO_SIDED|95.0|-61.14|-53.14||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Placebo is the reference|The null hypothesis was that there was no mean difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.||-53.14|-61.14|<0.001
72601608|NCT01763827|144732255|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-54.78|STANDARD_ERROR_OF_MEAN|1.87|<|0.001|TWO_SIDED|95.0|-58.46|-51.1||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Placebo is the reference|The null hypothesis was that there was no mean difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.||-51.10|-58.46|<0.001
72601609|NCT01763827|144732255|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-39.29|STANDARD_ERROR_OF_MEAN|2.03|<|0.001|TWO_SIDED|95.0|-43.28|-35.31||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Ezetimibe is the reference|The null hypothesis was that there was no mean difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and ezetimibe, and the alternative hypothesis was that a mean difference did exist.||-35.31|-43.28|<0.001
72601610|NCT01763827|144732255|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-37.55|STANDARD_ERROR_OF_MEAN|1.88|<|0.001|TWO_SIDED|95.0|-41.24|-33.86||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Ezetimibe is the reference|The null hypothesis was that there was no mean difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and ezetimibe, and the alternative hypothesis was that a mean difference did exist.||-33.86|-41.24|<0.001
72601611|NCT01763827|144732256|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-56.5|STANDARD_ERROR_OF_MEAN|1.76|<|0.001|TWO_SIDED|95.0|-59.95|-53.04||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Placebo is the reference|The null hypothesis was that there was no mean difference in the percent change from Baseline at the mean of Weeks 10 and 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.||-53.04|-59.95|<0.001
72601612|NCT01763827|144732256|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-57.4|STANDARD_ERROR_OF_MEAN|1.66|<|0.001|TWO_SIDED|95.0|-60.66|-54.14||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Placebo is the reference|The null hypothesis was that there was no mean difference in the percent change from Baseline at the mean of Weeks 10 and 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.||-54.14|-60.66|<0.001
72601613|NCT01763827|144732256|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-39.41|STANDARD_ERROR_OF_MEAN|1.76|<|0.001|TWO_SIDED|95.0|-42.87|-35.94||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Ezetimibe is the reference|The null hypothesis was that there was no mean difference in the percent change from Baseline at the mean of Weeks 10 and 12 in LDL-C between evolocumab and ezetimibe, and the alternative hypothesis was that a mean difference did exist.||-35.94|-42.87|<0.001
72601614|NCT01763827|144732256|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-36.69|STANDARD_ERROR_OF_MEAN|1.66|<|0.001|TWO_SIDED|95.0|-42.97|-36.42||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Ezetimibe is the reference|The null hypothesis was that there was no mean difference in the percent change from Baseline at the mean of Weeks 10 and 12 in LDL-C between evolocumab and ezetimibe, and the alternative hypothesis was that a mean difference did exist.||-36.42|-42.97|<0.001
72601615|NCT01763827|144732257|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-79.6|STANDARD_ERROR_OF_MEAN|2.7|<|0.001|TWO_SIDED|95.0|-85.0|-74.2||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Placebo is the reference|||-74.2|-85.0|<0.001
72601616|NCT01763827|144732257|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-81.9|STANDARD_ERROR_OF_MEAN|2.6|<|0.001|TWO_SIDED|95.0|-87.0|-76.9||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Placebo is the reference|||-76.9|-87.0|<0.001
72601617|NCT01763827|144732257|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-55.3|STANDARD_ERROR_OF_MEAN|2.7|<|0.001|TWO_SIDED|95.0|-60.7|-49.9||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Ezetimibe is the reference|||-49.9|-60.7|<0.001
72601618|NCT01763827|144732257|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-56.1|STANDARD_ERROR_OF_MEAN|2.6|<|0.001|TWO_SIDED|95.0|-61.1|-51.0||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Ezetimibe is the reference|||-51.0|-61.1|<0.001
72601619|NCT01763827|144732258|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-80.4|STANDARD_ERROR_OF_MEAN|3.1|<|0.001|TWO_SIDED|95.0|-86.4|-74.3||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Placebo is the reference|||-74.3|-86.4|<0.001
72601620|NCT01763827|144732258|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-77.8|STANDARD_ERROR_OF_MEAN|2.8|<|0.001|TWO_SIDED|95.0|-83.4|-72.2||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Placebo is the reference|||-72.2|-83.4|<0.001
72601621|NCT01763827|144732258|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-55.0|STANDARD_ERROR_OF_MEAN|3.1|<|0.001|TWO_SIDED|95.0|-61.1|-49.0||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Ezetimibe was the reference|||-49.0|-61.1|<0.001
72601622|NCT01763827|144732258|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-52.9|STANDARD_ERROR_OF_MEAN|2.9|<|0.001|TWO_SIDED|95.0|-58.5|-47.3||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit and the interaction of treatment with scheduled visit.|Ezetimibe was the reference|||-47.3|-58.5|<0.001
72601623|NCT01763827|144732259|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|73.6|||<|0.001|TWO_SIDED|95.0|64.4|80.2||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on CMH test stratified by Baseline LDL-C level. For testing, non-achievement was imputed for participants with a missing value.||||80.2|64.4|<0.001
72601624|NCT01763827|144732259|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|71.3|||<|0.001|TWO_SIDED|95.0|62.2|78.0||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on CMH test stratified by Baseline LDL-C level. For testing, non-achievement was imputed for participants with a missing value.||||78.0|62.2|<0.001
72601625|NCT01763827|144732259|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|72.2|||<|0.001|TWO_SIDED|95.0|62.4|78.9||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on CMH test stratified by Baseline LDL-C level. For testing, non-achievement was imputed for participants with a missing value.||||78.9|62.4|<0.001
72601626|NCT01763827|144732259|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|68.6|||<|0.001|TWO_SIDED|95.0|58.3|75.5||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on CMH test stratified by Baseline LDL-C level. For testing, non-achievement was imputed for participants with a missing value.||||75.5|58.3|<0.001
72601627|NCT01763827|144732260|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|71.5|||<|0.001|TWO_SIDED|95.0|61.2|78.4||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on CMH test stratified by Baseline LDL-C level. For testing, non-achievement was imputed for participants with a missing value.||||78.4|61.2|<0.001
72601628|NCT01763827|144732260|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|65.4|||<|0.001|TWO_SIDED|95.0|55.6|72.9||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on CMH test stratified by Baseline LDL-C level. For testing, non-achievement was imputed for participants with a missing value.||||72.9|55.6|<0.001
72601629|NCT01763827|144732260|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|71.5|||<|0.001|TWO_SIDED|95.0|61.3|78.4||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on CMH test stratified by Baseline LDL-C level. For testing, non-achievement was imputed for participants with a missing value.||||78.4|61.3|<0.001
72601630|NCT01763827|144732260|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|64.0|||<|0.001|TWO_SIDED|95.0|53.5|71.6||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on CMH test stratified by Baseline LDL-C level. For testing, non-achievement was imputed for participants with a missing value.||||71.6|53.5|<0.001
72601631|NCT01763827|144732261|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-48.81|STANDARD_ERROR_OF_MEAN|1.63|<|0.001|TWO_SIDED|95.0|-52.01|-45.61||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Placebo is the reference|||-45.61|-52.01|<0.001
72601632|NCT01763827|144732261|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-53.28|STANDARD_ERROR_OF_MEAN|1.5|<|0.001|TWO_SIDED|95.0|-56.23|-50.33||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Placebo is the reference|||-50.33|-56.23|<0.001
72601633|NCT01763827|144732261|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-35.58|STANDARD_ERROR_OF_MEAN|1.63|<|0.001|TWO_SIDED|95.0|-38.79|-32.38||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Ezetimibe is the reference|||-32.38|-38.79|<0.001
72601634|NCT01763827|144732261|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-35.49|STANDARD_ERROR_OF_MEAN|1.5|<|0.001|TWO_SIDED|95.0|-38.44|-32.53||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Ezetimibe is the reference|||-32.53|-38.44|<0.001
72601635|NCT01763827|144732262|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-49.81|STANDARD_ERROR_OF_MEAN|1.79|<|0.001|TWO_SIDED|95.0|-53.34|-46.27||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Placebo is the reference|||-46.27|-53.34|<0.001
72601636|NCT01763827|144732262|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-51.19|STANDARD_ERROR_OF_MEAN|1.67|<|0.001|TWO_SIDED|95.0|-54.49|-47.9||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Placebo is the reference|||-47.90|-54.49|<0.001
72601637|NCT01763827|144732262|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-35.23|STANDARD_ERROR_OF_MEAN|1.78|<|0.001|TWO_SIDED|95.0|-38.74|-31.71||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Ezetimibe is the reference|||-31.71|-38.74|<0.001
72601638|NCT01763827|144732262|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-33.21|STANDARD_ERROR_OF_MEAN|1.68|<|0.001|TWO_SIDED|95.0|-36.51|-29.9||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Ezetimibe is the reference|||-29.90|-36.51|<0.001
72601639|NCT01763827|144732263|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-47.09|STANDARD_ERROR_OF_MEAN|1.82|<|0.001|TWO_SIDED|95.0|-50.67|-43.51||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Placebo is the reference|||-43.51|-50.67|<0.001
72601640|NCT01763827|144732263|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-50.93|STANDARD_ERROR_OF_MEAN|1.7|<|0.001|TWO_SIDED|95.0|-54.27|-47.59||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Placebo is the reference|||-47.59|-54.27|<0.001
72601641|NCT01763827|144732263|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-33.57|STANDARD_ERROR_OF_MEAN|1.82|<|0.001|TWO_SIDED|95.0|-37.15|-29.99||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Ezetimibe is the reference|||-29.99|-37.15|<0.001
72601642|NCT01763827|144732263|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-34.64|STANDARD_ERROR_OF_MEAN|1.71|<|0.001|TWO_SIDED|95.0|-37.99|-31.28||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Ezetimibe is the reference|||-31.28|-37.99|<0.001
72601643|NCT01763827|144732264|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-47.81|STANDARD_ERROR_OF_MEAN|1.91|<|0.001|TWO_SIDED|95.0|-51.56|-44.05||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Placebo is the reference|||-44.05|-51.56|<0.001
72601644|NCT01763827|144732264|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-48.43|STANDARD_ERROR_OF_MEAN|1.85|<|0.001|TWO_SIDED|95.0|-52.07|-44.79||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Placebo is the reference|||-44.79|-52.07|<0.001
72601645|NCT01763827|144732264|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-34.04|STANDARD_ERROR_OF_MEAN|1.9|<|0.001|TWO_SIDED|95.0|-37.78|-30.3||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Ezetimibe is the reference|||-30.30|-37.78|<0.001
72416228|NCT01972841|144343297|SUPERIORITY||Least squares mean difference|-7.13|STANDARD_ERROR_OF_MEAN|1.21|<|0.001|TWO_SIDED|95.0|-9.5|-4.76|||ANCOVA|No adjustment for multiplicity was made for this comparison.||Difference of the adjusted mean calculated by subtracting the adjusted mean of the mirabegron 25 mg monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous overactive bladder medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||-4.76|-9.50|<0.001
72416229|NCT01972841|144343297|SUPERIORITY||Least squares mean difference|-6.1|STANDARD_ERROR_OF_MEAN|1.2|<|0.001|TWO_SIDED|95.0|-8.46|-3.74|||ANCOVA|No adjustment for multiplicity was made for this comparison.||Difference of the adjusted mean calculated by subtracting the adjusted mean of the mirabegron 50 mg monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous overactive bladder medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||-3.74|-8.46|<0.001
72601646|NCT01763827|144732264|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-32.57|STANDARD_ERROR_OF_MEAN|1.85|<|0.001|TWO_SIDED|95.0|-36.21|-28.92||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Ezetimibe is the reference|||-28.92|-36.21|<0.001
72601647|NCT01763827|144732265|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-38.93|STANDARD_ERROR_OF_MEAN|1.56|<|0.001|TWO_SIDED|95.0|-42.0|-35.86||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Placebo is the reference|||-35.86|-42.00|<0.001
72416230|NCT01972841|144343298|SUPERIORITY||Least squares mean difference|0.25|STANDARD_ERROR_OF_MEAN|0.14||0.077|TWO_SIDED|95.0|-0.03|0.52|||ANCOVA|No adjustment for multiplicity was made for this comparison.||Difference of the adjusted mean calculated by subtracting the adjusted mean of the solifenacin 5 mg monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous overactive bladder medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||0.52|-0.03|0.077
72601648|NCT01763827|144732265|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-45.83|STANDARD_ERROR_OF_MEAN|1.81|<|0.001|TWO_SIDED|95.0|-49.39|-42.27||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Placebo is the reference|||-42.27|-49.39|<0.001
72601649|NCT01763827|144732265|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-29.36|STANDARD_ERROR_OF_MEAN|1.56|<|0.001|TWO_SIDED|95.0|-32.43|-26.28||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Ezetimibe is the reference|||-26.28|-32.43|<0.001
72601650|NCT01763827|144732265|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-27.51|STANDARD_ERROR_OF_MEAN|1.81|<|0.001|TWO_SIDED|95.0|-31.08|-23.94||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Ezetimibe is the reference|||-23.94|-31.08|<0.001
72601651|NCT01763827|144732266|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-39.63|STANDARD_ERROR_OF_MEAN|1.69|<|0.001|TWO_SIDED|95.0|-42.97|-36.3||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Placebo is the reference|||-36.30|-42.97|<0.001
72601652|NCT01763827|144732266|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-44.67|STANDARD_ERROR_OF_MEAN|2.03|<|0.001|TWO_SIDED|95.0|-48.66|-40.68||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Placebo is the reference|||-40.68|-48.66|<0.001
72601653|NCT01763827|144732266|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-28.42|STANDARD_ERROR_OF_MEAN|1.68|<|0.001|TWO_SIDED|95.0|-31.73|-25.1||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Ezetimibe is the reference|||-25.10|-31.73|<0.001
72601654|NCT01763827|144732266|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-25.31|STANDARD_ERROR_OF_MEAN|2.03|<|0.001|TWO_SIDED|95.0|-29.31|-21.31||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Ezetimibe is the reference|||-21.31|-29.31|<0.001
72601655|NCT01763827|144732267|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-49.12|STANDARD_ERROR_OF_MEAN|2.03|<|0.001|TWO_SIDED|95.0|-53.12|-45.12||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Placebo is the reference|||-45.12|-53.12|<0.001
72601656|NCT01763827|144732267|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-54.95|STANDARD_ERROR_OF_MEAN|2.12|<|0.001|TWO_SIDED|95.0|-59.12|-50.78||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Placebo is the reference|||-50.78|-59.12|<0.001
72601657|NCT01763827|144732267|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-34.73|STANDARD_ERROR_OF_MEAN|2.03|<|0.001|TWO_SIDED|95.0|-38.73|-30.73||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Ezetimibe is the reference|||-30.73|-38.73|<0.001
72601658|NCT01763827|144732267|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-36.62|STANDARD_ERROR_OF_MEAN|2.13|<|0.001|TWO_SIDED|95.0|-40.81|-32.42||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Ezetimibe is the reference|||-32.42|-40.81|<0.001
72601659|NCT01763827|144732268|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-49.57|STANDARD_ERROR_OF_MEAN|2.14|<|0.001|TWO_SIDED|95.0|-53.78|-45.36||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Placebo is the reference|||-45.36|-53.78|<0.001
72601660|NCT01763827|144732268|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-52.77|STANDARD_ERROR_OF_MEAN|2.29|<|0.001|TWO_SIDED|95.0|-57.28|-48.26||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Placebo is the reference|||-48.26|-57.28|<0.001
72601661|NCT01763827|144732268|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-35.76|STANDARD_ERROR_OF_MEAN|2.13|<|0.001|TWO_SIDED|95.0|-39.95|-31.57||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Ezetimibe is the reference|||-31.57|-39.95|<0.001
72601662|NCT01763827|144732268|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-33.97|STANDARD_ERROR_OF_MEAN|2.29|<|0.001|TWO_SIDED|95.0|-38.48|-29.45||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Ezetimibe is the reference|||-29.45|-38.48|<0.001
72601663|NCT01763827|144732269|SUPERIORITY_OR_OTHER_LEGACY||Median Treatment Difference|-18.48|||<|0.001|TWO_SIDED|95.0|-25.28|-11.68||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Quade test|Adjusted for Baseline value|Median difference and 95% CI were obtained from McKean-Schrader algorithm.|||-11.68|-25.28|<0.001
72601664|NCT01763827|144732269|SUPERIORITY_OR_OTHER_LEGACY||Median Treatment Difference|-19.24|||<|0.001|TWO_SIDED|95.0|-23.2|-15.28||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Quade test|Adjusted for Baseline value|Median difference and 95% CI were obtained from McKean-Schrader algorithm.|||-15.28|-23.20|<0.001
72601665|NCT01763827|144732269|SUPERIORITY_OR_OTHER_LEGACY||Median Treatment Difference|-18.37|||<|0.001|TWO_SIDED|95.0|-24.39|-12.35||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Quade test|Adjusted for Baseline value|Median difference and 95% CI were obtained from McKean-Schrader algorithm.|||-12.35|-24.39|<0.001
72601666|NCT01763827|144732269|SUPERIORITY_OR_OTHER_LEGACY||Median Treatment Difference|-17.15|||<|0.001|TWO_SIDED|95.0|-23.23|-11.08||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Quade test|Adjusted for Baseline value|Median difference and 95% CI were obtained from McKean-Schrader algorithm.|||-11.08|-23.23|<0.001
72601667|NCT01763827|144732270|SUPERIORITY_OR_OTHER_LEGACY||Median Treatment Difference|-20.41|||<|0.001|TWO_SIDED|95.0|-27.76|-13.06||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Quade test|Adjusted for Baseline value|Median difference and 95% CI were obtained from McKean-Schrader algorithm.|||-13.06|-27.76|<0.001
72601668|NCT01763827|144732270|SUPERIORITY_OR_OTHER_LEGACY||Median Treatment Difference|-17.82|||<|0.001|TWO_SIDED|95.0|-24.51|-11.12||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Quade test|Adjusted for Baseline value|Median difference and 95% CI were obtained from McKean-Schrader algorithm.|||-11.12|-24.51|<0.001
72601669|NCT01763827|144732270|SUPERIORITY_OR_OTHER_LEGACY||Median Treatment Difference|-20.41|||<|0.001|TWO_SIDED|95.0|-28.13|-12.69||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Quade test|Adjusted for Baseline value|Median difference and 95% CI were obtained from McKean-Schrader algorithm.|||-12.69|-28.13|<0.001
72601670|NCT01763827|144732270|SUPERIORITY_OR_OTHER_LEGACY||Median Treatment Difference|-15.77|||<|0.001|TWO_SIDED|95.0|-24.39|-7.14||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Quade test|Adjusted for Baseline value|Median difference and 95% CI were obtained from McKean-Schrader algorithm.|||-7.14|-24.39|<0.001
72601671|NCT01763827|144732271|SUPERIORITY_OR_OTHER_LEGACY||Median Treatment Difference|-5.27||||0.72|TWO_SIDED|95.0|-13.27|2.73||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Quade test|Adjusted for Baseline value|Median difference and 95% CI were obtained from McKean-Schrader algorithm.|||2.73|-13.27|0.72
72601672|NCT01763827|144732271|SUPERIORITY_OR_OTHER_LEGACY||Median Treatment Difference|-20.59|||<|0.001|TWO_SIDED|95.0|-30.98|-10.2||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Quade test|Adjusted for Baseline value|Median difference and 95% CI were obtained from McKean-Schrader algorithm.|||-10.20|-30.98|<0.001
72601673|NCT01763827|144732271|SUPERIORITY_OR_OTHER_LEGACY||Median Treatment Difference|-7.71||||0.027|TWO_SIDED|95.0|-16.86|1.45||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Quade test|Adjusted for Baseline value|Median difference and 95% CI were obtained from McKean-Schrader algorithm.|||1.45|-16.86|0.027
72601674|NCT01763827|144732271|SUPERIORITY_OR_OTHER_LEGACY||Median Treatment Difference|-11.73||||0.044|TWO_SIDED|95.0|-21.19|-2.27||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Quade test|Adjusted for Baseline value|Median difference and 95% CI were obtained from McKean-Schrader algorithm.|||-2.27|-21.19|0.044
72601675|NCT01763827|144732272|SUPERIORITY_OR_OTHER_LEGACY||Median Treatment Difference|-6.23||||0.72|TWO_SIDED|95.0|-16.41|3.95||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Quade test|Adjusted for Baseline value|Median difference and 95% CI were obtained from McKean-Schrader algorithm.|||3.95|-16.41|0.72
72416231|NCT01972841|144343298|SUPERIORITY||Least squares mean difference|0.27|STANDARD_ERROR_OF_MEAN|0.14||0.05|TWO_SIDED|95.0|0.0|0.55|||ANCOVA|No adjustment for multiplicity was made for this comparison.||Difference of the adjusted mean calculated by subtracting the adjusted mean of the solifenacin 5 mg monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous overactive bladder medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||0.55|0.00|0.050
72601676|NCT01763827|144732272|SUPERIORITY_OR_OTHER_LEGACY||Median Treatment Difference|-17.65|||<|0.001|TWO_SIDED|95.0|-26.67|-8.63||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Quade test|Adjusted for Baseline value|Median difference and 95% CI were obtained from McKean-Schrader algorithm|||-8.63|-26.67|<0.001
72601677|NCT01763827|144732272|SUPERIORITY_OR_OTHER_LEGACY||Median Treatment Difference|-8.14||||0.027|TWO_SIDED|95.0|-17.54|1.26||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Quade test|Adjusted for Baseline value|Median difference and 95% CI were obtained from McKean-Schrader algorithm.|||1.26|-17.54|0.027
72601678|NCT01763827|144732272|SUPERIORITY_OR_OTHER_LEGACY||Median Treatment Difference|-13.23||||0.044|TWO_SIDED|95.0|-21.69|-4.77||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Quade test|Adjusted for Baseline value|Median difference and 95% CI were obtained from McKean-Schrader algorithm.|||-4.77|-21.69|0.044
72601679|NCT01763827|144732273|SUPERIORITY_OR_OTHER_LEGACY||Median Treatment Difference|-4.59||||0.072|TWO_SIDED|95.0|-11.3|2.12||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Quade test|Adjusted for Baseline value|Median difference and 95% CI were obtained from McKean-Schrader algorithm.|||2.12|-11.30|0.072
72601680|NCT01763827|144732273|SUPERIORITY_OR_OTHER_LEGACY||Median Treatment Difference|-20.39|||<|0.001|TWO_SIDED|95.0|-30.11|-10.68||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Quade test|Adjusted for Baseline value|Median difference and 95% CI were obtained from McKean-Schrader algorithm.|||-10.68|-30.11|<0.001
72601681|NCT01763827|144732273|SUPERIORITY_OR_OTHER_LEGACY||Median Treatment Difference|-5.71||||0.082|TWO_SIDED|95.0|-14.13|2.71||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Quade test|Adjusted for Baseline value|Median difference and 95% CI were obtained from McKean-Schrader algorithm.|||2.71|-14.13|0.082
72601682|NCT01763827|144732273|SUPERIORITY_OR_OTHER_LEGACY||Median Treatment Difference|-12.84||||0.044|TWO_SIDED|95.0|-22.14|-3.54||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Quade test|Adjusted for Baselie value|Median difference and 95% CI were obtained from McKean-Schrader algorithm.|||-3.54|-22.14|0.044
72601683|NCT01763827|144732274|SUPERIORITY_OR_OTHER_LEGACY||Median Treatment Difference|-7.94||||0.72|TWO_SIDED|95.0|-18.81|2.92||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Quade test|Adjusted for Baseline value|Median difference and 95% CI were obtained from McKean-Schrader algorithm.|||2.92|-18.81|0.72
72601684|NCT01763827|144732274|SUPERIORITY_OR_OTHER_LEGACY||Median Treatment Difference|-16.33|||<|0.001|TWO_SIDED|95.0|-25.64|-7.02||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Quade test|Adjusted for Baseline value|Median difference and 95% CI were obtained from McKean-Schrader algorithm.|||-7.02|-25.64|<0.001
72601685|NCT01763827|144732274|SUPERIORITY_OR_OTHER_LEGACY||Median Treatment Difference|-8.58||||0.082|TWO_SIDED|95.0|-18.1|0.94||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Quade test|Adjusted for Baseline value|Median difference and 95% CI were obtained from McKean-Schrader algorithm.|||0.94|-18.10|0.082
72601686|NCT01763827|144732274|SUPERIORITY_OR_OTHER_LEGACY||Median Treatment Difference|-12.72||||0.044|TWO_SIDED|95.0|-20.89|-4.54||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Quade test|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit as covariates.|Median difference and 95% CI were obtained from McKean-Schrader algorithm.|||-4.54|-20.89|0.044
72601687|NCT01763827|144732275|SUPERIORITY_OR_OTHER_LEGACY||Median Treatment Difference|5.53||||0.007|TWO_SIDED|95.0|2.23|8.84||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Quade test|Adjusted for Baseline value|Median difference and 95% CI were obtained from McKean-Schrader algorithm.|||8.84|2.23|0.007
72601688|NCT01763827|144732275|SUPERIORITY_OR_OTHER_LEGACY||Median Treatment Difference|8.48|||<|0.001|TWO_SIDED|95.0|5.53|11.43||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Quade test|Adjusted for Baseline value|Median difference and 95% CI were obtained from McKean-Schrader algorithm.|||11.43|5.53|<0.001
72601689|NCT01763827|144732275|SUPERIORITY_OR_OTHER_LEGACY||Median Treatment Difference|4.81||||0.013|TWO_SIDED|95.0|0.85|8.78||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Quade test|Adjusted for Baseline value|Median difference and 95% CI were obtained from McKean-Schrader algorithm.|||8.78|0.85|0.013
72601690|NCT01763827|144732275|SUPERIORITY_OR_OTHER_LEGACY||Median Treatment Difference|3.81||||0.044|TWO_SIDED|95.0|-0.77|8.39||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Quade test|Adjusted for Baseline visit|Median difference and 95% CI were obtained from McKean-Schrader algorithm.|||8.39|-0.77|0.044
72601691|NCT01763827|144732276|SUPERIORITY_OR_OTHER_LEGACY||Median Treatment Difference|5.91||||0.007|TWO_SIDED|95.0|1.67|10.16||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Quade test|Adjusted for Baseline value|Median difference and 95% CI were obtained from McKean-Schrader algorithm.|||10.16|1.67|0.007
72601692|NCT01763827|144732276|SUPERIORITY_OR_OTHER_LEGACY||Median Treatment Difference|9.33|||<|0.001|TWO_SIDED|95.0|5.32|13.34||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Quade test|Adjusted for Baseline value|Median difference and 95% CI were obtained from McKean-Schrader algorithm.|||13.34|5.32|<0.001
72601693|NCT01763827|144732276|SUPERIORITY_OR_OTHER_LEGACY||Median Treatment Difference|7.56||||0.013|TWO_SIDED|95.0|3.11|12.0||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Quade test|Adjusted for Baseline value|Median difference and 95% CI were obtained from McKean-Schrader algorithm.|||12.00|3.11|0.013
72416232|NCT01972841|144343298|SUPERIORITY||Least squares mean difference|0.37|STANDARD_ERROR_OF_MEAN|0.14||0.008|TWO_SIDED|95.0|0.1|0.65|||ANCOVA|No adjustment for multiplicity was made for this comparison.||Difference of the adjusted mean calculated by subtracting the adjusted mean of the mirabegron 25 mg monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous overactive bladder medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||0.65|0.10|0.008
72601694|NCT01763827|144732276|SUPERIORITY_OR_OTHER_LEGACY||Median Treatment Difference|5.53||||0.044|TWO_SIDED|95.0|2.22|8.84||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Quade test|Adjusted for Baseline value|Median difference and 95% CI were obtained from McKean-Schrader algorithm.|||8.84|2.22|0.044
72601695|NCT02179047|144732358|SUPERIORITY||Hazard Ratio (HR)|1.02||||0.002|TWO_SIDED||||||ANOVA|||||||0.002
72601696|NCT02179047|144732359|SUPERIORITY||Hazard Ratio (HR)|1.05|STANDARD_DEVIATION|0.005||0.002|TWO_SIDED|95.0|||||ANOVA|||||||0.002
72601697|NCT02179047|144732360|SUPERIORITY||Hazard Ratio (HR)|1.39|STANDARD_DEVIATION|0.005||0.001|TWO_SIDED||||||ANCOVA|||||||0.001
72601698|NCT01393522|144732365|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1|TWO_SIDED||||||ANCOVA|||||||0.1
72601699|NCT01393522|144732365|SUPERIORITY_OR_OTHER_LEGACY|||||||0.88|TWO_SIDED||||||t-test, 2 sided|||||||0.88
72601700|NCT01393522|144732366|SUPERIORITY_OR_OTHER_LEGACY|||||||0.33|TWO_SIDED||||||t-test, 2 sided|||||||0.33
72601701|NCT01393522|144732367|SUPERIORITY_OR_OTHER_LEGACY|||||||0.75|TWO_SIDED||||||ANCOVA|||||||0.75
72601702|NCT01393522|144732367|SUPERIORITY_OR_OTHER_LEGACY|||||||0.24|TWO_SIDED||||||t-test, 2 sided|||||||0.24
72601703|NCT01393522|144732368|SUPERIORITY_OR_OTHER_LEGACY|||||||0.16|TWO_SIDED||||||t-test, 2 sided|||||||0.16
72601704|NCT01393522|144732369|SUPERIORITY_OR_OTHER_LEGACY|||||||0.41|TWO_SIDED||||||t-test, 2 sided|||||||0.41
72601705|NCT01393522|144732370|SUPERIORITY_OR_OTHER_LEGACY|||||||0.09|TWO_SIDED||||||t-test, 2 sided|||||||0.09
72601706|NCT01393522|144732371|SUPERIORITY_OR_OTHER_LEGACY|||||||0.78|TWO_SIDED||||||t-test, 2 sided|||||||0.78
72601707|NCT03746405|144732374|SUPERIORITY||Mean Difference (Final Values)|1.15|||=|0.03|TWO_SIDED|||||Give the limited sample size, this p-value was not adjusted for multiple comparisons. The threshold for statistical significant was p \< 0.05|t-test, 2 sided|||Hypothesis: Active rTMS applied over the node in the medial prefrontal cortex the most strongly negatively connected to the right amygdala will decrease amygdala BOLD activation compared to sham rTMS||||= 0.03
72601708|NCT03479008|144732375|OTHER||||||<|0.0001||||||Statistical significance level was set at p \<0.05 for all tests.|ANOVA|||This presents the p value for the thigh comparison baseline to during stimulation||||<0.0001
72601709|NCT03479008|144732375|SUPERIORITY||||||<|0.0001||||||Statistical significance level was set at p \< 0.05 for all tests.|ANOVA|||This presents the p value for the calf comparisons between baseline and during stimulation.||||<0.0001
72601710|NCT03479008|144732375|OTHER||||||<|0.001||||||Statistical significance level was set at p \< 0.05 for all tests.|ANOVA|||This statistical analysis presents the data for the biceps comparisons between baseline and during stimulation.||||<0.001
72601711|NCT03479008|144732376|SUPERIORITY||||||<|0.0001|||||||post-hoc analysis|with Bonferroni correction||The P value below applies to the VO2||||<0.0001
72601712|NCT03479008|144732376|SUPERIORITY||||||<|0.001|||||||post-hoc analysis|with Bonferroni correction||This p value applies to the VCO2||||<0.001
72601713|NCT03479008|144732377|SUPERIORITY||||||<|0.0001|||||||post-hoc analysis|with Bonferroni correction||||||<0.0001
72601714|NCT03479008|144732378|SUPERIORITY||||||<|0.0001|||||||post-hoc analysis|with Bonferroni correction||||||<0.0001
72601715|NCT03479008|144732379|SUPERIORITY|||||||0.094|||||||post-hoc analysis|with Bonferroni correction||||||0.094
72601716|NCT03479008|144732380|SUPERIORITY|||||||0.011||||||Statistical significance level was set at p \<0.05 for all tests.|ANOVA|||Comparison of Vibration to Baseline for Muscle bellies of Soleus (SO)||||0.011
72601717|NCT03479008|144732380|SUPERIORITY|||||||0.012|||||||ANOVA|Statistical significance level was set at p \< 0.05 for all tests.||Comparison of Vibration to Baseline for tibialis anterior (TA)||||0.012
72601718|NCT03479008|144732380|SUPERIORITY|||||||0.003||||||Statistical significance level was set at p \< 0.05 for all tests.|ANOVA|||Comparison of Vibration to Baseline for gastrocnemius lateralis (GL)||||0.003
72601719|NCT03479008|144732380|SUPERIORITY||||||<|0.001||||||Statistical significance level was set at p \< 0.05 for all tests.|ANOVA|||Comparison of Vibration to Baseline for vastus medialis (VM)||||<0.001
72601720|NCT03479008|144732380|SUPERIORITY||||||<|0.0001||||||Statistical significance level was set at p \< 0.05 for all tests.|ANOVA|||Comparison of Vibration to Baseline for vastus lateralis (VL)||||<0.0001
72601721|NCT03479008|144732380|SUPERIORITY|||||||0.59||||||Statistical significance level was set at p \<0.05 for all tests.|ANOVA|||Comparison of Vibration to Baseline for rectus femoris (RF)||||0.59
72601722|NCT03479008|144732380|SUPERIORITY|||||||0.86||||||Statistical significance level was set at p \< 0.05 for all tests.|ANOVA|||Comparison of Vibration to Baseline for semitendinosus (ST)||||0.86
72601723|NCT03479008|144732380|SUPERIORITY|||||||0.006||||||Statistical significance level was set at p \< 0.05 for all tests.|ANOVA|||Comparison of Vibration to Baseline for deltoideus medius||||0.006
72601724|NCT00412932|144732381|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||No multiplicity adjustments|one-sample t-test|||The sample size of this study was not based on the statistical power consideration and was considered as sufficient for the evaluation of the efficacy and safety of the proposed olmesartan medoxomil-based treatment regimen.||||<0.0001
72601725|NCT00412932|144732382|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||One-sample t-test|||||||<0.0001
72601726|NCT00412932|144732383|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||No multiplicity adjustments. This P-Value applies to both the daytime and nighttime periods.|one-sample t-test|||||||<0.0001
72601727|NCT00412932|144732384|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||No multiplicity adjustments. The P-Value of \<0.0001 applies to both daytime and nighttime periods.|one-sample t-test|||||||<0.0001
72416233|NCT01972841|144343298|SUPERIORITY||Least squares mean difference|0.37|STANDARD_ERROR_OF_MEAN|0.14||0.007|TWO_SIDED|95.0|0.1|0.65|||ANCOVA|No adjustment for multiplicity was made for this comparison.||Difference of the adjusted mean calculated by subtracting the adjusted mean of the mirabegron 50 mg monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous overactive bladder medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||0.65|0.10|0.007
72416234|NCT01972841|144343299|SUPERIORITY||Rate ratio|0.87|STANDARD_ERROR_OF_MEAN|0.09||0.135|TWO_SIDED|95.0|0.72|1.04|||Negative binomial regression|||Rate ratio of number of incontinence episodes during the 7-day diary between the given combination group and the given monotherapy group calculated from a negative binomial regression model incl. treatment group, sex, age group (\<65, ≥65 years), geographic region and previous OAB medication (yes, no) as factors, log(number of incontinence episodes used divided by number of valid diary days) at baseline included as a covariate and number of valid diary days at EoT as the offset variable.||1.04|0.72|0.135
72601728|NCT01490840|144732388|NON_INFERIORITY_OR_EQUIVALENCE|A sample size of 90 in each group would have 80% power to detect a difference in means of 3.8, assuming that the common standard deviation is 9.05, using a two group t-test with a 0.05 2-sided significance level.|Mean Difference (Net)|-1.47||||0.4579|TWO_SIDED|95.0|-5.39|2.44|||ANCOVA|||||2.44|-5.39|0.4579
72601729|NCT01703169|144732397|OTHER||||||||||||||||||The proportion of platelet response in a previous study (PMID:22762314) was 0.36 (9/25). The null hypothesis of no difference between the platelet response rate in this study and that of the previous study was tested using a two-sided exact test of binomial proportions. A p-value of 0.40 was obtained. The threshold for significance was 0.05.|||
72601730|NCT02362191|144732443|OTHER|||||||0.758||||||The threshold for statistical significance is 0.05.|t-test, 2 sided|||||||0.758
72601731|NCT02362191|144732444|OTHER|||||||0.4||||||The threshold for statistical significance is 0.05.|t-test, 2 sided|||||||0.40
72601732|NCT00947310|144732451|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.45||||0.01|TWO_SIDED|95.0|0.24|0.85|||Regression, Cox|||Hazard ratios (HR) were calculated to compare Arm A vs Arm B. Null Hypothesis was that HR = 1||0.85|0.24|0.01
72601733|NCT00947310|144732451|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.56||||0.06|TWO_SIDED|95.0|0.3|1.02|||Regression, Cox|||Hazard ratios (HR) were calculated to compare Arm A vs Arm C. Null Hypothesis was that HR = 1||1.02|0.30|0.06
72601734|NCT00947310|144732452|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.32||||0.39|TWO_SIDED|95.0|0.71|2.47|||Regression, Cox|||Hazard ratios (HR) were calculated to compare Arm A vs Arm B. Null Hypothesis was that HR = 1||2.47|0.71|0.39
72601735|NCT00947310|144732452|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.09||||0.8|TWO_SIDED|95.0|0.58|2.05|||Regression, Cox|||Hazard ratios (HR) were calculated to compare Arm A vs Arm C. Null Hypothesis was that HR = 1||2.05|0.58|0.80
72601736|NCT00947310|144732453|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.21|||<|0.001|TWO_SIDED|95.0|0.13|0.34|||Regression, Cox|||Hazard ratios (HR) were calculated to compare Arm A vs Arm B. Null Hypothesis was that HR = 1||0.34|0.13|<0.001
72601737|NCT00947310|144732453|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.24|||<|0.001|TWO_SIDED|95.0|0.15|0.4|||Regression, Cox|||Hazard ratios (HR) were calculated to compare Arm A vs Arm C. Null Hypothesis was that HR = 1||0.40|0.15|<0.001
72601738|NCT01473940|144732454|OTHER|||||||||||||P-Value not used||||A 3 + 3 enrollment design was adopted to monitor safety and determine the MTD based on DLTs obsesved. The MTD is the highest dose at which 0 of 3 or 1 of 6 DLTs are detected. The MTD is exceeded if 2 of 3 or 2 of 6 DLTs are detected. There will be no dose escalation within a cohort.|The number of DLTs seen at each cohort were used to determine the MTD for the expansion cohort. The MTD was determined to be Gemcitabine - 1,000 mg/m2, Ipilimumab 3 mg/kg|||
72601739|NCT00547248|144732461|NON_INFERIORITY|Non-inferiority was demonstrated if the difference in terms of incidence of post-immunization febrile reactions (rectal temperature \> 39.0°C) in Synflorix™ vaccine minus Prevenar™ did not exceed the pre-defined clinically acceptable threshold of 5% + half the incidence in Prevenar.|Difference in percentage|0.89|||||TWO_SIDED|95.0|-4.82|5.59|||Philips' statistical test|||||5.59|-4.82|
72601740|NCT00534248|144732489|SUPERIORITY_OR_OTHER||point estimate|0.698|||<|0.001|TWO_SIDED|95.0|0.541|0.806|||Conditional Exact Method||The point estimate was for vaccine efficacy with respect to incidence of HZ.|Vaccine efficacy with respect to HZ was defined as the relative reduction in incidence rate of HZ point estimate (95% CI) calculated as 1 minus the ratio of the estimated incidence rates of HZ in the zoster vaccine group and the placebo group.||.806|.541|<.001
72601741|NCT00534248|144732490|SUPERIORITY_OR_OTHER||geometric mean titre ratio|2.3|||<|0.001|TWO_SIDED|95.0|2.2|2.4|||linear mixed longitudinal analysis model|||||2.4|2.2|<.001
72601742|NCT00534248|144732491|SUPERIORITY_OR_OTHER||Relative Risk|1.133|||||TWO_SIDED|95.0|0.805|1.595||||||Analysis of proportion of participants reporting one or more serious adverse experiences reported within 42 days postvaccination.||1.595|.805|
72601743|NCT02259400|144732512|NON_INFERIORITY_OR_EQUIVALENCE|For the calculation of sample size we used the duration of ventilation as the main primary outcome. As no basic data are available for this population, we were able to retrieve from the database of our two NICUs the duration of ventilation on NIV. We assumed a difference of 24-h between the two groups in the duration of NIV as clinically relevant. We used a confidence level α=0.05; the power level desired was 0.80 and consequently we needed 62 patients for each group.|||||<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||< 0.05
72601744|NCT02964338|144732559|OTHER||Least square (LS) mean difference|3.5||||0.2741|TWO_SIDED|95.0|-2.8|9.82||Threshold for significance at 0.05 level.|ANCOVA|||||9.82|-2.80|0.2741
72601745|NCT02964338|144732559|OTHER||LS mean difference|-3.3||||0.3047|TWO_SIDED|95.0|-9.59|3.01||Threshold for significance at 0.05 level.|ANCOVA|||||3.01|-9.59|0.3047
72601746|NCT00112918|144732572|SUPERIORITY_OR_OTHER|||||||0.2024||95.0|||||Closed test procedure|||Adjustments for multiplicity was done using a closed test procedure which tests for differences between all three treatment groups at the 5% alpha level first. Only in case of a significant result, the pair-wise comparison between the control arm and each of the bevacizumab arm will be tested, again at the 5% alpha level.||||0.2024
72601747|NCT05076604|144732588|SUPERIORITY|||||||0.354|||||||t-test, 2 sided|||Intraoperative packed red blood cell transfusion||||0.354
72601748|NCT05076604|144732588|SUPERIORITY|||||||0.314|||||||t-test, 2 sided|||Postoperative red blood cell transfusion||||0.314
72601749|NCT03258645|144732590|OTHER||||||<|0.001|||||||Regression, Linear|||Univariate linear regression with the continuous dependent variable of time-to-initiation for dabigatran in days and independent variable of National Institute of Health Stroke Scale (NIHSS) score at index date was applied.||||< 0.001
72601750|NCT03258645|144732591|OTHER|||||||0.01|||||||Regression, Linear|||Univariate linear regression with the continuous dependent variable of time-to-initiation for dabigatran in days and independent variable of Modified Rankin Scale (mRS) at index date was applied.||||0.01
72601751|NCT03258645|144732592|OTHER|CHA2DS2-VASc is the Congestive heart failure, Hypertension, Age (\> 75), Diabetes mellitus, Stroke/TIA, Vascular disease, Age 65-74, Sex Category score. HAS-BLED is the Hypertension, Abnormal renal and liver function, Stroke (1 point), Bleeding history or predisposition, Labile INR, Elderly (\>65 years), Drugs and Alcohol Score.|Odds Ratio (OR)|1.13||||0.016|TWO_SIDED|95.0|1.02|1.25|||Regression, Linear|Relation between age and dabigatran initiation time was reported.||Multivariate linear regression with the continuous dependent variable of time-to-initiation for dabigatran in days and independent variable of age, Diastolic blood pressure (DBP), CHA2DS2-VASc, HAS-BLED, and History/Predisposition To Bleeding at index date was applied.||1.25|1.02|0.016
72601752|NCT03258645|144732593|OTHER|CHA2DS2-VASc is the Congestive heart failure, Hypertension, Age (\> 75), Diabetes mellitus, Stroke/TIA, Vascular disease, Age 65-74, Sex Category score. HAS-BLED is the Hypertension, Abnormal renal and liver function, Stroke (1 point), Bleeding history or predisposition, Labile INR, Elderly (\>65 years), Drugs and Alcohol Score.|Odds Ratio (OR)|1.12||||0.002|TWO_SIDED|95.0|1.04|1.21|||Regression, Linear|Relation between Diastolic blood pressure (DBP) and dabigatran initiation time was reported.||Multivariate linear regression with the continuous dependent variable of time-to-initiation for dabigatran in days and independent variable of age, Diastolic blood pressure (DBP), CHA2DS2-VASc, HAS-BLED, and History/Predisposition To Bleeding at index date was applied.||1.21|1.04|0.002
72601753|NCT03258645|144732594|OTHER|CHA2DS2-VASc is the Congestive heart failure, Hypertension, Age (\> 75), Diabetes mellitus, Stroke/TIA, Vascular disease, Age 65-74, Sex Category score. HAS-BLED is the Hypertension, Abnormal renal and liver function, Stroke (1 point), Bleeding history or predisposition, Labile INR, Elderly (\>65 years), Drugs and Alcohol Score.|Odds Ratio (OR)|1.1||||0.04|TWO_SIDED|95.0|1.0|1.21|||Regression, Linear|Relation between CHA2DS2-VASc and dabigatran initiation time was reported.||Multivariate linear regression with the continuous dependent variable of time-to-initiation for dabigatran in days and independent variable of age, Diastolic blood pressure (DBP), CHA2DS2-VASc, HAS-BLED, and History/Predisposition To Bleeding at index date was applied.||1.21|1.00|0.04
72601754|NCT03258645|144732595|OTHER|CHA2DS2-VASc is the Congestive heart failure, Hypertension, Age (\> 75), Diabetes mellitus, Stroke/TIA, Vascular disease, Age 65-74, Sex Category score. HAS-BLED is the Hypertension, Abnormal renal and liver function, Stroke (1 point), Bleeding history or predisposition, Labile INR, Elderly (\>65 years), Drugs and Alcohol Score.|Odds Ratio (OR)|0.9||||0.051|TWO_SIDED|95.0|0.45|1.0|||Regression, Linear|Relation between HAS-BLED and dabigatran initiation time was reported.||Multivariate linear regression with the continuous dependent variable of time-to-initiation for dabigatran in days and independent variable of age, Diastolic blood pressure (DBP), CHA2DS2-VASc, HAS-BLED, and History/Predisposition To Bleeding at index date was applied.||1.00|0.45|0.051
72601755|NCT03258645|144732596|OTHER|CHA2DS2-VASc is the Congestive heart failure, Hypertension, Age (\> 75), Diabetes mellitus, Stroke/TIA, Vascular disease, Age 65-74, Sex Category score. HAS-BLED is the Hypertension, Abnormal renal and liver function, Stroke (1 point), Bleeding history or predisposition, Labile INR, Elderly (\>65 years), Drugs and Alcohol Score.|Odds Ratio (OR)|0.91||||0.026|TWO_SIDED|95.0|0.9|0.93|||Regression, Linear|Relation between History/Predisposition To Bleeding and dabigatran initiation time was reported.||Multivariate linear regression with the continuous dependent variable of time-to-initiation for dabigatran in days and independent variable of age, Diastolic blood pressure (DBP), CHA2DS2-VASc, HAS-BLED, and History/Predisposition To Bleeding at index date was applied.||0.93|0.9|0.026
72601756|NCT01704755|144732601|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The noninferiority of the rate of sustained virologic response for the ABT-450/r/ABT-333 plus ribavirin 12-week treatment group as compared with the historical rate for telaprevir plus peginterferon-ribavirin. The lower confidence bound of the 2-sided 97.5% CI for the percentage of participants with sustained virologic response at 12 weeks after treatment must have exceeded 43% to achieve noninferiority.|Percentage of Participants|91.8|||||TWO_SIDED|97.5|87.6|96.1||||||The study planned to enroll 380 subjects to a 12- or 24-week treatment arm. The primary efficacy endpoint (SVR12) was assessed for each arm. With a total sample size of 380 and assuming that 68% of the subjects in each arm would achieve SVR12, the study had greater than 90% power to demonstrate non-inferiority and superiority with a 2-sided 97.5% lower confidence bound greater than 43% and 54%, respectively, based on the normal approximation of a single binomial proportion.||96.1|87.6|
72601757|NCT01704755|144732601|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The superiority of the rate of sustained virologic response for the ABT-450/r/ABT-333 plus ribavirin 12-week treatment group as compared with the historical rate for telaprevir plus peginterferon-ribavirin. The lower confidence bound of the 2-sided 97.5% CI for the percentage of participants with sustained virologic response at 12 weeks after treatment must have exceeded 54% to achieve superiority.|Percentage of Participants|91.8|||||TWO_SIDED|97.5|87.6|96.1||||||The primary efficacy endpoints were the SVR12 rates in each arm. The overall 2-sided significance level of 0.05 was split between the arms using a Bonferroni correction of 0.025. A 2-sided 97.5% CI of the SVR12 rate per arm was computed using the normal approximation to the binomial distribution. A gatekeeping testing procedure was used to control the Type I error rate at 0.05, and the primary endpoints for Arm A were tested separately from Arm B in a pre-specified order.||96.1|87.6|
72416235|NCT01972841|144343299|SUPERIORITY||Rate ratio|0.9|STANDARD_ERROR_OF_MEAN|0.09||0.282|TWO_SIDED|95.0|0.75|1.09|||Negative binomial regression|||Rate ratio of number of incontinence episodes during the 7-day diary between the given combination group and the given monotherapy group calculated from a negative binomial regression model incl. treatment group, sex, age group (\<65, ≥65 years), geographic region and previous OAB medication (yes, no) as factors, log(number of incontinence episodes used divided by number of valid diary days) at baseline included as a covariate and number of valid diary days at EoT as the offset variable.||1.09|0.75|0.282
72416236|NCT01972841|144343299|SUPERIORITY||Rate ratio|0.71|STANDARD_ERROR_OF_MEAN|0.09|<|0.001|TWO_SIDED|95.0|0.59|0.85|||Negative binomial regression|||Rate ratio of number of incontinence episodes during the 7-day diary between the given combination group and the given monotherapy group calculated from a negative binomial regression model incl. treatment group, sex, age group (\<65, ≥65 years), geographic region and previous OAB medication (yes, no) as factors, log(number of incontinence episodes used divided by number of valid diary days) at baseline included as a covariate and number of valid diary days at EoT as the offset variable.||0.85|0.59|<0.001
72421631|NCT03720938|144354390|SUPERIORITY|||||||0.00238||||||The outcome of self-perception for sports competence was tested for any difference between groups by linear mixed-effects model analysis.|Linear mixed-effects model|Adjusted by Satterthwaite's degrees of freedom method for cluster effect, and small sample sizes in addition to baseline value and age.||Null hypothesis was the absence of difference between the two groups for the dependent variable self-perception of global self-worth.||||0.00238
72601758|NCT01704755|144732601|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The noninferiority of the rate of sustained virologic response for the ABT-450/r/ABT-333 plus ribavirin 24-week treatment group as compared with the historical rate for telaprevir plus peginterferon-ribavirin. The lower confidence bound of the 2-sided 97.5% CI for the percentage of participants with sustained virologic response at 12 weeks after treatment must have exceeded 43% to achieve noninferiority.|Percentage of Participants|96.5|||||TWO_SIDED|97.5|93.4|99.7||||||||99.7|93.4|
72601759|NCT01704755|144732601|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The superiority of the rate of sustained virologic response for the ABT-450/r/ABT-333 plus ribavirin 24-week treatment group as compared with the historical rate for telaprevir plus peginterferon-ribavirin. The lower confidence bound of the 2-sided 97.5% CI for the percentage of participants with sustained virologic response at 12 weeks after treatment must have exceeded 54% to achieve superiority.|Percentage of Participants|96.5|||||TWO_SIDED|97.5|93.4|99.7||||||||99.7|93.4|
72601760|NCT01704755|144732602|SUPERIORITY_OR_OTHER_LEGACY|||||||0.051|TWO_SIDED||||||Regression, Logistic|||To test the hypothesis that the percentages of participants who achieved sustained virologic response 12 weeks after treatment was different between the two treatment groups, the percentages were compared using a logistic regression model with treatment group, baseline log(subscript)10(subscript) HCV RNA level, HCV subgenotype (1a, non-1a), IL28B genotype (CC, non CC), and peginterferon-ribavirin treatment history (treatment-naïve or treatment-experienced) as predictors.||||0.051
72601761|NCT01639703|144732658|OTHER||Odds Ratio (OR)|0.76||||0.2476|TWO_SIDED|95.0|0.47|1.21|||Regression, Logistic||Odds-ratio is the risk to move from one immunochemistry category to the below one (among 0%, 1-10%, 10-50% and \>50%) considering an increase of 5 units for Blood Volume|Multinomial logistic regression analyses were performed with each off-site CT perfusion parameters as explicative variables taken alone and each off-site immunohistochemistry categorized parameters as dependent variables.||1.21|0.47|0.2476
72601762|NCT01639703|144732659|OTHER||Odds Ratio (OR)|1.13||||0.5354|TWO_SIDED|95.0|0.77|1.66|||Regression, Logistic||Odds-ratio is the risk to move from one immunochemistry category to the below one (among 0%, 1-10%, 10-50% and \>50%) considering an increase of 5 units for Blood Volume|Multinomial logistic regression analyses were performed with each off-site CT perfusion parameters as explicative variables taken alone and each off-site immunohistochemistry categorized parameters as dependent variables.||1.66|0.77|0.5354
72421632|NCT03720938|144354391|SUPERIORITY|||||||0.194||||||Tested the significance of gender between genders|Wilcoxon (Mann-Whitney)|||"Enjoyment scale of physical activity sports in intervention group between male and female genders"||||0.194
72601763|NCT01639703|144732660|OTHER||Odds Ratio (OR)|0.9||||0.3487|TWO_SIDED|95.0|0.71|1.13|||Regression, Logistic||Odds-ratio is the risk to move from one immunochemistry category to the below one (among 0%, 1-10%, 10-50% and \>50%) considering an increase of 10 units for Blood Flow|Multinomial logistic regression analyses were performed with each off-site CT perfusion parameters as explicative variables taken alone and each off-site immunohistochemistry categorized parameters as dependent variables.||1.13|0.71|0.3487
72601764|NCT01639703|144732661|OTHER||Odds Ratio (OR)|1.08||||0.4195|TWO_SIDED|95.0|0.9|1.29|||Regression, Logistic||Odds-ratio is the risk to move from one immunochemistry category to the below one (among 0%, 1-10%, 10-50% and \>50%) considering an increase of 10 units for Blood Flow|Multinomial logistic regression analyses were performed with each off-site CT perfusion parameters as explicative variables taken alone and each off-site immunohistochemistry categorized parameters as dependent variables.||1.29|0.90|0.4195
72601765|NCT01639703|144732662|OTHER||Odds Ratio (OR)|0.9||||0.7127|TWO_SIDED|95.0|0.53|1.54|||Regression, Logistic||Odds-ratio is the risk to move from one immunochemistry category to the below one (among 0%, 1-10%, 10-50% and \>50%) considering an increase of 10 units for Permeability Surface|Multinomial logistic regression analyses were performed with each off-site CT perfusion parameters as explicative variables taken alone and each off-site immunohistochemistry categorized parameters as dependent variables.||1.54|0.53|0.7127
72601766|NCT01639703|144732663|OTHER||Odds Ratio (OR)|1.41||||0.1753|TWO_SIDED|95.0|0.86|2.31|||Regression, Logistic||Odds-ratio is the risk to move from one immunochemistry category to the below one (among 0%, 1-10%, 10-50% and \>50%) considering an increase of 10 units for Permeability Surface|Multinomial logistic regression analyses were performed with each off-site CT perfusion parameters as explicative variables taken alone and each off-site immunohistochemistry categorized parameters as dependent variables.||2.31|0.86|0.1753
72601767|NCT00551525|144732704|SUPERIORITY_OR_OTHER||||||<|0.001||||||Significance level 0.05, two-sided test|binomial proportion|||||||<0.001
72601768|NCT00551525|144732707|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.984|||||TWO_SIDED|95.0|0.91|1.063||||||Modeling the association of age with the occurrence of any acute radiotherapy-related adverse event, adjusting for clinical T-stage (pT2 vs. pT3 \[reference level\]), baseline PSA, and Gleason score (\<8 vs. 8-10\[reference level\]).||1.063|0.910|
72601769|NCT00551525|144732707|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.02|||||TWO_SIDED|95.0|0.89|1.169||||||Modeling the association of baseline PSA with the occurrence of any acute radiotherapy-related adverse event, adjusting for clinical T-stage (pT2 vs. pT3 \[reference level\]), Gleason score (\<8 vs. 8-10\[reference level\]), and age.||1.169|0.890|
72601770|NCT00551525|144732707|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.307|||||TWO_SIDED|95.0|0.364|4.697||||||Modeling the association of clinical T-stage (pT2 vs. pT3 \[reference level\]) with the occurrence of any acute radiotherapy-related adverse event, adjusting for baseline PSA, Gleason score (\<8 vs. 8-10\[reference level\]), and age.||4.697|0.364|
72601771|NCT00551525|144732707|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.659|||||TWO_SIDED|95.0|0.217|2.006||||||Modeling the association of Gleason score (\<8 vs. 8-10\[reference level\]) with the occurrence of any acute radiotherapy-related adverse event, adjusting for clinical T-stage (pT2 vs. pT3 \[reference level\]), baseline PSA, and age.||2.006|0.217|
72601772|NCT04676724|144732743|OTHER||Difference in SVR Rate|-3.0|||||TWO_SIDED|95.0|-29.0|11.0|||||The point estimate of SVR and its 95% highest posterior density Credible Interval (CI) are estimated from a Bayesian model that incorporates the analysis stratification factors and treatment arm.|||11|-29|
72601773|NCT01150903|144732752|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Chi-squared|||Chi-square test was used to calculate p-value.||||<0.001
72601774|NCT01150903|144732753|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Chi-squared|||Chi-square test was used to calculate p-value.||||<0.001
72601775|NCT04274075|144732781|OTHER||Geometric Mean Ratio|1.03|||||TWO_SIDED|90.0|0.945|1.12|||||The geometric mean ratio was calculated as Treatment B versus Treatment A.|The sample size chosen for this study was based upon precedent set by other PK studies of similar nature and was not based on power calculations.||1.12|0.945|
72601776|NCT04274075|144732781|OTHER||Geometric Mean Ratio|0.79|||||TWO_SIDED|90.0|0.726|0.859|||||The geometric mean ratio was calculated as Treatment C versus Treatment B.|The sample size chosen for this study was based upon precedent set by other PK studies of similar nature and was not based on power calculations.||0.859|0.726|
72601777|NCT04274075|144732782|OTHER||Median Difference (Net)|0.525|||||TWO_SIDED|90.0|-0.225|1.5|||||The Hodges-Lehmann estimate of median difference was calculated as Treatment B versus Treatment A.|The sample size chosen for this study was based upon precedent set by other PK studies of similar nature and was not based on power calculations.||1.50|-0.225|
72601778|NCT04274075|144732782|OTHER||Median Difference (Net)|1.98|||||TWO_SIDED|90.0|1.26|2.45|||||The Hodges-Lehmann estimate of median difference was calculated as Treatment C versus Treatment B.|The sample size chosen for this study was based upon precedent set by other PK studies of similar nature and was not based on power calculations.||2.45|1.26|
72601779|NCT04274075|144732785|OTHER||Geometric Mean Ratio|0.971|||||TWO_SIDED|90.0|0.903|1.04|||||The geometric mean ratio was calculated as Treatment B versus Treatment A.|The sample size chosen for this study was based upon precedent set by other PK studies of similar nature and was not based on power calculations.||1.04|0.903|
72601780|NCT04274075|144732785|OTHER||Geometric Mean Ratio|0.919|||||TWO_SIDED|90.0|0.855|0.988|||||The geometric mean ratio was calculated as Treatment C versus Treatment B.|The sample size chosen for this study was based upon precedent set by other PK studies of similar nature and was not based on power calculations.||0.988|0.855|
72601781|NCT04274075|144732786|OTHER||Geometric Mean Ratio|0.975|||||TWO_SIDED|90.0|0.908|1.05|||||The geometric mean ratio was calculated as Treatment B versus Treatment A.|The sample size chosen for this study was based upon precedent set by other PK studies of similar nature and was not based on power calculations.||1.05|0.908|
72601782|NCT04274075|144732786|OTHER||Geometric Mean Ratio|0.918|||||TWO_SIDED|90.0|0.856|0.985|||||The geometric mean ratio was calculated as Treatment C versus Treatment B.|The sample size chosen for this study was based upon precedent set by other PK studies of similar nature and was not based on power calculations.||0.985|0.856|
72421633|NCT03720938|144354392|SUPERIORITY|||||||0.809|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis was the absence of difference between the two genders in the Active video game group for the variable of enjoyment from sports category.||||0.809
72601783|NCT00099632|144732801|SUPERIORITY_OR_OTHER_LEGACY|||||||0.37||95.0|||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by ARV regimen and the actual receipt of antenatal ZDV||Compare proportion of women with new NNRTI-resistant variants between treatment durations (7-day vs. 21 day), pooled over ARV regimens (3TC/ZDV, FTC/TDF, and LPV/r), stratified by ARV regimen and the actual receipt of antenatal ZDV||||0.37
72421634|NCT03720938|144354393|SUPERIORITY|||||||0.843|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis was the absence of difference between the two genders in the active video game group for the variable of enjoyment from balance category.||||0.843
72601784|NCT00099632|144732801|SUPERIORITY_OR_OTHER_LEGACY|||||||0.091||95.0|||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by treatment duration and the actual receipt of antenatal ZDV||Compare proportion of women with new NNRTI-resistant variants among ARV regimens (3TC/ZDV vs. FTC/TDF vs. LPV/r), pooled over treatment durations 7-day and 21-day, stratified by treatment duration and the actual receipt of antenatal ZDV||||0.091
72601785|NCT03658642|144732806|SUPERIORITY||Odds Ratio (OR)|1.22||||0.58|TWO_SIDED|95.0|0.61|2.43|||GEE|Obtained from a GEE model accounting for clustering by site and multiple covariates.||||2.43|0.61|0.58
72601786|NCT03658642|144732807|SUPERIORITY||Odds Ratio (OR)|1.03||||0.95|TWO_SIDED|95.0|0.43|2.47|||GEE|Obtained from a GEE model accounting for clustering by site.||||2.47|0.43|0.95
72601787|NCT03658642|144732809|SUPERIORITY||Odds Ratio (OR)|1.55||||0.01|TWO_SIDED|95.0|1.11|2.16|||GEE|Obtained from a GEE model accounting for clustering by site.||||2.16|1.11|0.01
72601788|NCT03658642|144732810|SUPERIORITY||Odds Ratio (OR)|1.13||||0.48|TWO_SIDED|95.0|0.91|1.57|||GEE|Obtained from a GEE model accounting for clustering by site.||||1.57|0.91|0.48
72601789|NCT03658642|144732811|SUPERIORITY||Odds Ratio (OR)|1.32||||0.27|TWO_SIDED|95.0|0.81|2.14|||GEE|Obtained from a GEE model accounting for clustering by site.||||2.14|0.81|0.27
72601790|NCT02137226|144732839|NON_INFERIORITY_OR_EQUIVALENCE|The 90% Confidence Interval (CI) for ACR20 at Week 12, rounded to 1 decimal place, had to be entirely contained in the predefined equivalence region \[-12.0%, 15.0%\]|Difference in proportions|5.9|||||TWO_SIDED|90.0|-0.9|12.7|||Regression, Logistic||Results from logistic regression model adjusted for treatment, prior exposure to a biologic agent (yes / no), Baseline DAS28 (ESR). Difference in ACR20 Response Rate (BI695501 - Humira, %) is presented.|The week 12 confidence interval for the estimated difference in proportion is produced using the cumulative distribution function method of Reeve||12.7|-0.9|
72601791|NCT02137226|144732840|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence margin is not applicable|Mean Difference (Final Values)|-0.1|||||TWO_SIDED|90.0|-0.25|0.05|||ANCOVA||Difference in least square means of BI 695501 - Humira is presented.|Results based on DAS28 (ESR) mean changes from Baseline after 12 weeks of treatment = overall mean + treatment group + Baseline DAS28 (ESR) + prior exposure to a biologic agent + random error.||0.05|-0.25|
72601792|NCT02137226|144732840|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence margin is not applicable|Mean Difference (Final Values)|0.0|||||TWO_SIDED|95.0|-0.17|0.23|||ANCOVA||Difference in least square means of BI 695501 - Humira is presented.|Results based on DAS28 (ESR) mean changes from Baseline after 24 weeks of treatment = overall mean + treatment group + Baseline DAS28 (ESR) + prior exposure to a biologic agent + random error.||0.23|-0.17|
72421635|NCT03720938|144354394|SUPERIORITY|||||||0.247|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis was the absence of difference between the two genders in the active video game group for the variable of enjoyment from aerobic category.||||0.247
72601793|NCT02137226|144732842|NON_INFERIORITY_OR_EQUIVALENCE|The 95% Confidence Interval (CI) for ACR20 at Week 24, rounded to 1 decimal place, had to be entirely contained in the predefined equivalence region \[-15.0%;+15.0%\]|Difference in proportions|4.5|||||TWO_SIDED|95.0|-3.4|12.5|||Regression, Logistic||Results from logistic regression model adjusted for treatment, prior exposure to a biologic agent (yes / no), Baseline DAS28 (ESR). Difference in ACR20 Response Rate (BI695501 - Humira, %) is presented.|The week 24 confidence interval for the estimated difference in proportion is produced using the cumulative distribution function method of Reeve||12.5|-3.4|
72601794|NCT02373137|144732854|SUPERIORITY||Coefficient|-1.8|||<|0.001|TWO_SIDED|95.0|-2.8|-1.0|||Regression, Linear|Multiple linear regression model with a covariate for baseline visual acuity.|Coefficient reported in lines, comparing DMEK to UT-DSAEK. Compared to UT-DSAEK, DMEK had 1.8 lines better vision at 6 months.|||-1.0|-2.8|<0.001
72601795|NCT02373137|144732855|SUPERIORITY||Coefficient|-1.5||||0.002|TWO_SIDED|95.0|-2.5|-0.6|||Regression, Linear|Multiple linear regression model with a covariate for baseline visual acuity|Coefficient reported in lines, comparing DMEK to UT-DSAEK. Compared to UT-DSAEK, DMEK had 1.5 lines better vision at 3 months.|Comparison of 3-Month Visual Acuity Between Groups||-0.6|-2.5|0.002
72601796|NCT02373137|144732855|SUPERIORITY||Coefficient|-1.4|||<|0.001|TWO_SIDED|95.0|-2.2|-0.7|||Regression, Linear|Multiple linear regression model with a covariate for baseline visual acuity|Coefficient reported in lines, comparing DMEK to UT-DSAEK. Compared to UT-DSAEK, DMEK had 1.4 lines better vision at 12 months.|Comparison of 12 Month Visual Acuity Between Groups||-0.7|-2.2|<0.001
72601797|NCT02373137|144732857|SUPERIORITY||Coefficient|-77.0||||0.53|TWO_SIDED|95.0|-326.0|172.0|||t-test, 2 sided||Comparing DMEK to UT-DSAEK at 3 months.|||172|-326|0.53
72601798|NCT02373137|144732857|SUPERIORITY||Coefficient|-150.0||||0.17|TWO_SIDED|95.0|-356.0|66.0|||t-test, 2 sided||Comparing DMEK to UT-DSAEK at 6 months.|||66|-356|0.17
72601799|NCT02373137|144732857|SUPERIORITY||Coefficient|-215.0||||0.051|TWO_SIDED|95.0|-430.0|-0.4|||t-test, 2 sided||Comparing DMEK to UT-DSAEK at 12 months.|||-0.4|-430|0.051
72601800|NCT02373137|144732863|SUPERIORITY|||||||0.7|||||||t-test, 2 sided|||||||0.70
72601801|NCT02559570|144732901|SUPERIORITY||Least Squares Mean Difference|-0.042|STANDARD_ERROR_OF_MEAN|0.149||0.7789|TWO_SIDED|95.0|-0.335|0.252|||ANCOVA|ANCOVA model estimates/t-tests comparing specified treatment groups, controlling for age group and baseline value.|ANCOVA model was applied with treatment arm groups (linaclotide doses A, B, and C, and placebo) and age group (6 to 11 years of age and 12 to 17 years of age) as factors and baseline value as covariate.|||0.252|-0.335|0.7789
72601802|NCT02559570|144732901|SUPERIORITY||Least Squares Mean Difference|0.001|STANDARD_ERROR_OF_MEAN|0.143||0.993|TWO_SIDED|95.0|-0.282|0.284|||ANCOVA|ANCOVA model estimates/t-tests comparing specified treatment groups, controlling for age group and baseline value.|ANCOVA model was applied with treatment arm groups (linaclotide doses A, B, and C, and placebo) and age group (6 to 11 years of age and 12 to 17 years of age) as factors and baseline value as covariate.|||0.284|-0.282|0.9930
72601803|NCT02559570|144732901|SUPERIORITY||Least Squares Mean Difference|0.12|STANDARD_ERROR_OF_MEAN|0.146||0.4107|TWO_SIDED|95.0|-0.167|0.408|||ANCOVA|ANCOVA model estimates/t-tests comparing specified treatment groups, controlling for age group and baseline value.|ANCOVA model was applied with treatment arm groups (linaclotide doses A, B, and C, and placebo) and age group (6 to 11 years of age and 12 to 17 years of age) as factors and baseline value as covariate.|||0.408|-0.167|0.4107
72601804|NCT02559570|144732902|SUPERIORITY||Least Squares Mean Difference|-0.588|STANDARD_ERROR_OF_MEAN|0.577||0.3097|TWO_SIDED|95.0|-1.729|0.552|||ANCOVA|ANCOVA model estimates/t-tests comparing specified treatment groups, controlling for age group and baseline value.|ANCOVA model was applied with treatment arm groups (linaclotide doses A, B, and C, and placebo) and age group (6 to 11 years of age and 12 to 17 years of age) as factors and baseline value as covariate.|||0.552|-1.729|0.3097
72601805|NCT02559570|144732902|SUPERIORITY||Least Squares Mean Difference|-0.186|STANDARD_ERROR_OF_MEAN|0.557||0.7384|TWO_SIDED|95.0|-1.286|0.913|||ANCOVA|ANCOVA model estimates/t-tests comparing specified treatment groups, controlling for age group and baseline value.|ANCOVA model was applied with treatment arm groups (linaclotide doses A, B, and C, and placebo) and age group (6 to 11 years of age and 12 to 17 years of age) as factors and baseline value as covariate.|||0.913|-1.286|0.7384
72601806|NCT02559570|144732902|SUPERIORITY||Least Squares Mean Difference|0.364|STANDARD_ERROR_OF_MEAN|0.563||0.5188|TWO_SIDED|95.0|-0.748|1.477|||ANCOVA|ANCOVA model estimates/t-tests comparing specified treatment groups, controlling for age group and baseline value.|ANCOVA model was applied with treatment arm groups (linaclotide doses A, B, and C, and placebo) and age group (6 to 11 years of age and 12 to 17 years of age) as factors and baseline value as covariate.|||1.477|-0.748|0.5188
72601807|NCT02559570|144732903|SUPERIORITY||Least Squares Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.249||0.8426|TWO_SIDED|95.0|-0.543|0.444|||ANCOVA|ANCOVA model estimates/t-tests comparing specified treatment groups, controlling for age group and baseline value.|ANCOVA model was applied with treatment arm groups (linaclotide doses A, B, and C, and placebo) and age group (6 to 11 years of age and 12 to 17 years of age) as factors and baseline value as covariate.|Adult derivation||0.444|-0.543|0.8426
72601808|NCT02559570|144732903|SUPERIORITY||Least Squares Mean Difference|-0.038|STANDARD_ERROR_OF_MEAN|0.246||0.877|TWO_SIDED|95.0|-0.525|0.448|||ANCOVA|ANCOVA model estimates/t-tests comparing specified treatment groups, controlling for age group and baseline value.|ANCOVA model was applied with treatment arm groups (linaclotide doses A, B, and C, and placebo) and age group (6 to 11 years of age and 12 to 17 years of age) as factors and baseline value as covariate.|Adult derivation||0.448|-0.525|0.8770
72601809|NCT02559570|144732903|SUPERIORITY||Least Squares Mean Difference|0.356|STANDARD_ERROR_OF_MEAN|0.246||0.1502|TWO_SIDED|95.0|-0.131|0.842|||ANCOVA|ANCOVA model estimates/t-tests comparing specified treatment groups, controlling for age group and baseline value.|ANCOVA model was applied with treatment arm groups (linaclotide doses A, B, and C, and placebo) and age group (6 to 11 years of age and 12 to 17 years of age) as factors and baseline value as covariate.|Adult derivation||0.842|-0.131|0.1502
72601810|NCT02559570|144732903|SUPERIORITY||Least Squares Mean Difference|-0.062|STANDARD_ERROR_OF_MEAN|0.239||0.7949|TWO_SIDED|95.0|-0.535|0.41|||ANCOVA|ANCOVA model estimates/t-tests comparing specified treatment groups, controlling for age group and baseline value.|ANCOVA model was applied with treatment arm groups (linaclotide doses A, B, and C, and placebo) and age group (6 to 11 years of age and 12 to 17 years of age) as factors and baseline value as covariate.|Weighted average||0.410|-0.535|0.7949
72601811|NCT02559570|144732903|SUPERIORITY||Least Squares Mean Difference|-0.074|STANDARD_ERROR_OF_MEAN|0.235||0.7543|TWO_SIDED|95.0|-0.54|0.392|||ANCOVA|ANCOVA model estimates/t-tests comparing specified treatment groups, controlling for age group and baseline value.|ANCOVA model was applied with treatment arm groups (linaclotide doses A, B, and C, and placebo) and age group (6 to 11 years of age and 12 to 17 years of age) as factors and baseline value as covariate.|Weighted average||0.392|-0.540|0.7543
72601812|NCT02559570|144732903|SUPERIORITY||Least Squares Mean Difference|0.262|STANDARD_ERROR_OF_MEAN|0.235||0.2676|TWO_SIDED|95.0|-0.204|0.728|||ANCOVA|ANCOVA model estimates/t-tests comparing specified treatment groups, controlling for age group and baseline value.|ANCOVA model was applied with treatment arm groups (linaclotide doses A, B, and C, and placebo) and age group (6 to 11 years of age and 12 to 17 years of age) as factors and baseline value as covariate.|Weighted average||0.728|-0.204|0.2676
72601813|NCT02559570|144732904|SUPERIORITY||Least Squares Mean Difference|-0.053|STANDARD_ERROR_OF_MEAN|0.208||0.7997|TWO_SIDED|95.0|-0.465|0.359|||ANCOVA|ANCOVA model estimates/t-tests comparing specified treatment groups, controlling for age group and baseline value.|ANCOVA model was applied with treatment arm groups (linaclotide doses A, B, and C, and placebo) and age group (6 to 11 years of age and 12 to 17 years of age) as factors and baseline value as covariate.|Adult derivation||0.359|-0.465|0.7997
72601814|NCT02559570|144732904|SUPERIORITY||Least Squares Mean Difference|-0.121|STANDARD_ERROR_OF_MEAN|0.207||0.5602|TWO_SIDED|95.0|-0.53|0.288|||ANCOVA|ANCOVA model estimates/t-tests comparing specified treatment groups, controlling for age group and baseline value.|ANCOVA model was applied with treatment arm groups (linaclotide doses A, B, and C, and placebo) and age group (6 to 11 years of age and 12 to 17 years of age) as factors and baseline value as covariate.|Adult derivation||0.288|-0.530|0.5602
72601815|NCT02559570|144732904|SUPERIORITY||Least Squares Mean Difference|-0.236|STANDARD_ERROR_OF_MEAN|0.205||0.2529|TWO_SIDED|95.0|-0.641|0.17|||ANCOVA|ANCOVA model estimates/t-tests comparing specified treatment groups, controlling for age group and baseline value.|ANCOVA model was applied with treatment arm groups (linaclotide doses A, B, and C, and placebo) and age group (6 to 11 years of age and 12 to 17 years of age) as factors and baseline value as covariate.|Adult derivation||0.170|-0.641|0.2529
72601816|NCT02559570|144732904|SUPERIORITY||Least Squares Mean Difference|-0.054|STANDARD_ERROR_OF_MEAN|0.206||0.7923|TWO_SIDED|95.0|-0.461|0.352|||ANCOVA|ANCOVA model estimates/t-tests comparing specified treatment groups, controlling for age group and baseline value.|ANCOVA model was applied with treatment arm groups (linaclotide doses A, B, and C, and placebo) and age group (6 to 11 years of age and 12 to 17 years of age) as factors and baseline value as covariate.|Weighted average||0.352|-0.461|0.7923
72601817|NCT02559570|144732904|SUPERIORITY||Least Squares Mean Difference|-0.113|STANDARD_ERROR_OF_MEAN|0.204||0.5802|TWO_SIDED|95.0|-0.517|0.29|||ANCOVA|ANCOVA model estimates/t-tests comparing specified treatment groups, controlling for age group and baseline value.|ANCOVA model was applied with treatment arm groups (linaclotide doses A, B, and C, and placebo) and age group (6 to 11 years of age and 12 to 17 years of age) as factors and baseline value as covariate.|Weighted average||0.290|-0.517|0.5802
72601818|NCT02559570|144732904|SUPERIORITY||Least Squares Mean Difference|-0.199|STANDARD_ERROR_OF_MEAN|0.202||0.3263|TWO_SIDED|95.0|-0.6|0.201|||ANCOVA|ANCOVA model estimates/t-tests comparing specified treatment groups, controlling for age group and baseline value.|ANCOVA model was applied with treatment arm groups (linaclotide doses A, B, and C, and placebo) and age group (6 to 11 years of age and 12 to 17 years of age) as factors and baseline value as covariate.|Weighted average||0.201|-0.600|0.3263
72601819|NCT02559570|144732905|SUPERIORITY||Least Squares Mean Difference|0.048|STANDARD_ERROR_OF_MEAN|0.152||0.7507|TWO_SIDED|95.0|-0.252|0.349|||ANCOVA|ANCOVA model estimates/t-tests comparing specified treatment groups, controlling for age group and baseline value.|ANCOVA model was applied with treatment arm groups (linaclotide doses A, B, and C, and placebo) and age group (6 to 11 years of age and 12 to 17 years of age) as factors and baseline value as covariate.|||0.349|-0.252|0.7507
72601820|NCT02559570|144732905|SUPERIORITY||Least Squares Mean Difference|0.028|STANDARD_ERROR_OF_MEAN|0.146||0.8505|TWO_SIDED|95.0|-0.262|0.317|||ANCOVA|ANCOVA model estimates/t-tests comparing specified treatment groups, controlling for age group and baseline value.|ANCOVA model was applied with treatment arm groups (linaclotide doses A, B, and C, and placebo) and age group (6 to 11 years of age and 12 to 17 years of age) as factors and baseline value as covariate.|||0.317|-0.262|0.8505
72601821|NCT02559570|144732905|SUPERIORITY||Least Squares Mean Difference|0.039|STANDARD_ERROR_OF_MEAN|0.149||0.7933|TWO_SIDED|95.0|-0.254|0.332|||ANCOVA|ANCOVA model estimates/t-tests comparing specified treatment groups, controlling for age group and baseline value.|ANCOVA model was applied with treatment arm groups (linaclotide doses A, B, and C, and placebo) and age group (6 to 11 years of age and 12 to 17 years of age) as factors and baseline value as covariate.|||0.332|-0.254|0.7933
72601822|NCT02559570|144732906|SUPERIORITY||Least Squares Mean Difference|-0.425|STANDARD_ERROR_OF_MEAN|0.45||0.3461|TWO_SIDED|95.0|-1.313|0.463|||ANCOVA|ANCOVA model estimates/t-tests comparing specified treatment groups, controlling for age group and baseline value.|ANCOVA model was applied with treatment arm groups (linaclotide doses A, B, and C, and placebo) and age group (6 to 11 years of age and 12 to 17 years of age) as factors and baseline value as covariate.|||0.463|-1.313|0.3461
72601823|NCT02559570|144732906|SUPERIORITY||Least Squares Mean Difference|-0.235|STANDARD_ERROR_OF_MEAN|0.435||0.5892|TWO_SIDED|95.0|-1.095|0.624|||ANCOVA|ANCOVA model estimates/t-tests comparing specified treatment groups, controlling for age group and baseline value.|ANCOVA model was applied with treatment arm groups (linaclotide doses A, B, and C, and placebo) and age group (6 to 11 years of age and 12 to 17 years of age) as factors and baseline value as covariate.|||0.624|-1.095|0.5892
72601824|NCT02559570|144732906|SUPERIORITY||Least Squares Mean Difference|0.08|STANDARD_ERROR_OF_MEAN|0.44||0.856|TWO_SIDED|95.0|-0.789|0.949|||ANCOVA|ANCOVA model estimates/t-tests comparing specified treatment groups, controlling for age group and baseline value.|ANCOVA model was applied with treatment arm groups (linaclotide doses A, B, and C, and placebo) and age group (6 to 11 years of age and 12 to 17 years of age) as factors and baseline value as covariate.|||0.949|-0.789|0.8560
72601825|NCT04388176|144732908|EQUIVALENCE|Differences in treatment groups in the primary endpoint (log (AUC)) was to be detected with a power of 90% and alpha=0.1.|Ratio in least square means|1.0146|||=|0.3801|TWO_SIDED|90.0|0.9859|1.0442|||ANCOVA|||||1.0442|0.9859|=0.3801
72601826|NCT04388176|144732909|EQUIVALENCE|Differences between treatment groups was to be detected with a power of 90% and alpha=0.1.|Ratio in least square means|1.0346|||=|0.0356|TWO_SIDED|90.0|1.0086|1.0613|||ANCOVA|||||1.0613|1.0086|=0.0356
72601827|NCT04388176|144732910|EQUIVALENCE|Differences between treatment groups was to be detected with a power of 90% and alpha=0.1.|Difference in least square means|-0.4991|||=|0.0154|TWO_SIDED|90.0|-0.8234|-0.1749|||ANCOVA|||Analysis at the 10 min point||-0.1749|-0.8234|=0.0154
72601828|NCT04388176|144732911|EQUIVALENCE|Differences between treatment groups was to be detected with a power of 90% and alpha=0.1.|Ratio in least square means|0.8301|||=|0.282|TWO_SIDED|90.0|0.6206|1.1102|||ANCOVA|||||1.1102|0.6206|=0.282
72601829|NCT04388176|144732912|EQUIVALENCE|Differences between treatment groups was to be detected with a power of 90% and alpha=0.1|Difference in least square means|-0.3989|||=|0.3722|TWO_SIDED|90.0|-1.1718|0.3739|||ANCOVA|||||0.3739|-1.1718|=0.3722
72601830|NCT04388176|144732913|EQUIVALENCE|Differences between treatment groups was to be detected with a power of 90% and alpha=0.1|Difference in least square means|-0.109|||=|0.4982|TWO_SIDED|90.0|-0.4074|0.1895|||ANCOVA|||Analysis of capillaroscopy before cold||0.1895|-0.4074|=0.4982
72601831|NCT04388176|144732913|EQUIVALENCE|A difference between treatment groups was detected with a power of 90% and alpha=0.1|Difference in least square means|-0.0637|||=|0.6219|TWO_SIDED|90.0|-0.3037|0.1763|||ANCOVA|||Analysis of capillaroscopy post recovery||0.1763|-0.3037|=0.6219
72601832|NCT04560868|144732919|EQUIVALENCE|The point null hypothesis was a difference in expected number of log ins of exactly 0.|Mean Difference (Final Values)|12.73|||<|0.01|TWO_SIDED|95.0|6.41|19.05|||Regression, Linear||mean difference=experimental-control|Based on a priori power calculations we had 80% power to detect an average increase of 3.8 log ins in the experimental relative to the control arm.||19.05|6.41|<0.01
72601833|NCT04560868|144732920|EQUIVALENCE|The null hypothesis was a point null of relative risk equal to exactly 1.|Risk Ratio (RR)|1.01||||0.98|TWO_SIDED|95.0|0.55|1.85|||Regression, Poisson||relative risk=experimental/control|Based on a priori power calculations, we had 80% power to detect a 33% - 35% increase in the proportion of experimental participants who successfully quit smoking for at least 24 hours relative to controls.||1.85|0.55|0.98
72601834|NCT04560868|144732921|EQUIVALENCE|The null hypothesis was a point null of exactly 0 risk difference between arms.|Risk Difference (RD)|0.08||||0.35|TWO_SIDED|95.0|-0.08|0.24|||Regression, Linear||Risk difference = experimental - control.|Based on a priori power calculations, we had 80% power to detect a 28% - 33% increase in 7-day smoking abstinence in the experimental arm relative to the control arm at 3 months.||0.24|-0.08|0.35
72601835|NCT04560868|144732922|EQUIVALENCE|The null hypothesis was a point null of exactly 0 difference in expected score between arms.|Mean Difference (Final Values)|0.26||||0.4|TWO_SIDED|95.0|-0.35|0.87|||Regression, Linear||mean difference=experimental-control|||0.87|-0.35|0.40
72601836|NCT04560868|144732923|EQUIVALENCE|The null hypothesis was a point null of exactly 0 difference in expected score between arms.|Mean Difference (Final Values)|-0.04||||0.9|TWO_SIDED|95.0|-0.68|0.6|||Regression, Linear||mean difference=experimental-control|||0.60|-0.68|0.90
72601837|NCT04560868|144732924|EQUIVALENCE|The tested hypothesis was a point null of 0 difference in expected average helpfulness score between arms.|Mean Difference (Final Values)|0.4||||0.39|TWO_SIDED|95.0|-0.5|1.4|||Regression, Linear||mean difference=experimental-control|||1.4|-0.5|0.39
72601838|NCT04560868|144732925|EQUIVALENCE|The tested hypothesis was for a point null of 0 difference in expected average helpfulness score between arms.|Mean Difference (Final Values)|0.6||||0.11|TWO_SIDED|95.0|-0.1|1.3|||Regression, Linear||mean difference=experimental-control|||1.3|-0.1|0.11
72601839|NCT04560868|144732927|EQUIVALENCE|The null hypothesis was a point null of exactly 0 difference in expected number of badges earned in each arm by 3 months post-baseline.|Mean Difference (Final Values)|4.2|||<|0.01|TWO_SIDED|95.0|1.72|6.65|||Regression, Linear||mean difference=experimental-control|||6.65|1.72|<0.01
72601840|NCT04560868|144732928|EQUIVALENCE|The null hypothesis was a point null of exactly 0 difference in expected score between arms.|Mean Difference (Final Values)|0.08||||0.96|TWO_SIDED|95.0|-1.02|1.18|||Regression, Linear||mean difference=experimental-control|||1.18|-1.02|0.96
72601841|NCT04560868|144732929|EQUIVALENCE|The null hypothesis was a point null hypothesis of exactly 0 difference in expected score between the arms.|Mean Difference (Final Values)|-0.44||||0.31|TWO_SIDED|95.0|-1.55|0.66|||Regression, Linear||mean difference=experimental-control|||0.66|-1.55|0.31
72601842|NCT04560868|144732933|EQUIVALENCE|The point null hypothesis was of the exact same proportion of control and experimental subjects requesting NRT.|Risk Ratio (RR)|3.9||||0.06|TWO_SIDED|95.0|0.9|16.9|||Regression, Poisson||RR=experimental/control|||16.9|0.9|0.06
72601843|NCT04560868|144732934|EQUIVALENCE|The null hypothesis was a point null of exactly 0 difference in probability of the outcome between arms.|Risk Ratio (RR)|1.01||||0.99|TWO_SIDED|95.0|0.38|2.65|||Regression, Poisson||risk ratio=experimental/control|||2.65|0.38|0.99
72601844|NCT04560868|144732935|EQUIVALENCE|The null hypothesis was a point null of exactly 0 difference in expected change from baseline in number of cigarettes smoked per day between arms.|Mean Difference (Net)|1.39||||0.3|TWO_SIDED|95.0|-1.21|3.99|||Regression, Linear||treatment difference=experimental-control, where the outcome for each individual is (one month)-baseline.|||3.99|-1.21|0.30
72601845|NCT04560868|144732936|EQUIVALENCE|The null hypothesis was a point null of exactly 0 difference in expected change in daily cigarette usage between arms.|Mean Difference (Net)|1.5||||0.47|TWO_SIDED|95.0|-2.51|5.5|||Regression, Linear||treatment effect=experimental-control, where the outcome for each individual is (three month)-baseline.|||5.5|-2.51|0.47
72601846|NCT04560868|144732937|EQUIVALENCE|The null hypothesis was risk difference of exactly 0.|Risk Difference (RD)|0.04||||0.3|TWO_SIDED|95.0|-0.03|0.11|||Regression, Linear||risk difference=experimental-control|||0.11|-0.03|0.30
72601847|NCT02488018|144732947|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED|99.0|||||ANOVA|Degree of freedom for the model (treatment) was 8.||Hypothesis Ho: Honey plant origin does not affects the glycemic index of human subjects. Ha: Honey plant origin affects the glycemic index of human subjects.||||<0.01
72601848|NCT05446142|144732960|OTHER||Reference/Test Ratio|95.25|||||TWO_SIDED|90.0|90.82|99.9||||||Natural log transformed encorafenib AUCinf was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences (eMCC relative to CAP) and corresponding 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (eMCC relative to CAP) and 90% CIs for the ratios. The geometric mean ratios are presented as percentages.||99.90|90.82|
72601849|NCT05446142|144732960|OTHER||Reference/Test Ratio|96.3|||||TWO_SIDED|90.0|91.71|101.12||||||Natural log transformed encorafenib AUCinf was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences (eMCCL relative to CAP) and corresponding 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (eMCCL relative to CAP) and 90% CIs for the ratios. The geometric mean ratios are presented as percentages.||101.12|91.71|
72601850|NCT05446142|144732960|OTHER||Reference/Test Ratio|96.57|||||TWO_SIDED|90.0|82.91|112.47||||||Natural log transformed encorafenib AUCinf was analyzed using ANOVA with treatment and sequence as a fixed effect and participant within sequence as a random effect. The adjusted mean differences (eMCC relative to eMCC with rabeprazole) and corresponding 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (eMCC relative to eMCC with rabeprazole) and 90% CIs for the ratios. The geometric mean ratios are presented as percentages.||112.47|82.91|
72601851|NCT05446142|144732960|OTHER||Reference/Test Ratio|88.56|||||TWO_SIDED|90.0|82.59|94.95||||||Natural log transformed encorafenib AUCinf was analyzed using ANOVA with treatment and sequence as a fixed effect and participant within sequence as a random effect. The adjusted mean differences (eMCCL relative to eMCCL with rabeprazole) and corresponding 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (eMCCL relative to eMCCL with rabeprazole) and 90% CIs for the ratios. The geometric mean ratios are presented as percentages.||94.95|82.59|
72601852|NCT05446142|144732961|OTHER||Reference/Test Ratio|104.31|||||TWO_SIDED|90.0|91.4|119.04||||||Natural log transformed encorafenib Cmax was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences (eMCC relative to CAP) and corresponding 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (eMCC relative to CAP) and 90% CIs for the ratios. The geometric mean ratios are presented as percentages.||119.04|91.40|
72601853|NCT05446142|144732961|OTHER||Reference/Test Ratio|90.35|||||TWO_SIDED|90.0|79.17|103.12||||||Natural log transformed encorafenib Cmax was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences (eMCCL relative to CAP) and corresponding 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (eMCCL relative to CAP) and 90% CIs for the ratios. The geometric mean ratios are presented as percentages.||103.12|79.17|
72601854|NCT05446142|144732961|OTHER||Reference/Test Ratio|79.66|||||TWO_SIDED|90.0|58.7|108.08||||||Natural log transformed encorafenib Cmax was analyzed using ANOVA with treatment and sequence as a fixed effect and participant within sequence as a random effect. The adjusted mean differences (eMCC relative to eMCC with rabeprazole) and corresponding 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (eMCC relative to eMCC with rabeprazole) and 90% CIs for the ratios. The geometric mean ratios are presented as percentages.||108.08|58.70|
72601855|NCT05446142|144732961|OTHER||Reference/Test Ratio|80.78|||||TWO_SIDED|90.0|64.82|100.68||||||Natural log transformed encorafenib Cmax was analyzed using ANOVA with treatment and sequence as a fixed effect and participant within sequence as a random effect. The adjusted mean differences (eMCCL relative to eMCCL with rabeprazole) and corresponding 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (eMCCL relative to eMCCL with rabeprazole) and 90% CIs for the ratios. The geometric mean ratios are presented as percentages.||100.68|64.82|
72601856|NCT05446142|144732962|OTHER||Reference/Test Ratio|95.34|||||TWO_SIDED|90.0|90.37|100.59||||||Natural log transformed encorafenib AUClast was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences (eMCC relative to CAP) and corresponding 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (eMCC relative to CAP) and 90% CIs for the ratios. The geometric mean ratios are presented as percentages.||100.59|90.37|
72601857|NCT05446142|144732962|OTHER||Reference/Test Ratio|94.67|||||TWO_SIDED|90.0|89.73|99.88||||||Natural log transformed encorafenib AUClast was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences (eMCCL relative to CAP) and corresponding 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (eMCCL relative to CAP) and 90% CIs for the ratios. The geometric mean ratios are presented as percentages.||99.88|89.73|
72601858|NCT05446142|144732962|OTHER||Reference/Test Ratio|95.76|||||TWO_SIDED|90.0|84.1|109.04||||||Natural log transformed encorafenib AUClast was analyzed using ANOVA with treatment and sequence as a fixed effect and participant within sequence as a random effect. The adjusted mean differences (eMCC relative to eMCC with rabeprazole) and corresponding 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (eMCC relative to eMCC with rabeprazole) and 90% CIs for the ratios. The geometric mean ratios are presented as percentages.||109.04|84.10|
72601859|NCT05446142|144732962|OTHER||Reference/Test Ratio|88.31|||||TWO_SIDED|90.0|82.36|94.7||||||Natural log transformed encorafenib AUClast was analyzed using ANOVA with treatment and sequence as a fixed effect and participant within sequence as a random effect. The adjusted mean differences (eMCCL relative to eMCCL with rabeprazole) and corresponding 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (eMCCL relative to eMCCL with rabeprazole) and 90% CIs for the ratios. The geometric mean ratios are presented as percentages.||94.70|82.36|
72421636|NCT03720938|144354395|SUPERIORITY|||||||0.543|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis was the absence of difference between the two genders in the active video game group for the variable of enjoyment from training category.||||0.543
72601860|NCT02098395|144732971|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.35|||<|0.0001|TWO_SIDED|95.0|-0.5|-0.2|||Mixed Models Analysis|||Superiority of liraglutide 1.8 mg versus placebo was planned to be concluded if and only if the upper limit of the two-sided 95% confidence interval for the estimated difference in HbA1c was less than zero.||-0.2|-0.5|< 0.0001
72601861|NCT02098395|144732971|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.23|||=|0.0021|TWO_SIDED|95.0|-0.38|-0.08|||Mixed Models Analysis|||Superiority of liraglutide 1.2 mg was planned to be evaluated only if superiority for liraglutide 1.8 mg was concluded.||-0.08|-0.38|= 0.0021
72601862|NCT02098395|144732971|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.24|||=|0.0011|TWO_SIDED|95.0|-0.39|-0.1|||Mixed Models Analysis|||Superiority of liraglutide 0.6 mg versus placebo was planned to be evaluated only if superiority of liraglutide 1.2 mg was concluded.||-0.1|-0.39|= 0.0011
72601863|NCT01151345|144733025|SUPERIORITY_OR_OTHER||Adjusted geometric means ratio|88.65|||||TWO_SIDED|90.0|81.23|96.75||||||Natural-log transformed AUC (0-t) was analyzed using a mixed effect model with sequence, period, and treatment as fixed effects and participant within sequence as a random effect.||96.75|81.23|
72601864|NCT01151345|144733026|SUPERIORITY_OR_OTHER||Adjusted geometric means ratio|91.26|||||TWO_SIDED|90.0|83.83|99.34||||||Natural-log transformed AUC (0-∞) was analyzed using a mixed effect model with sequence, period, and treatment as fixed effects and participant within sequence as a random effect.||99.34|83.83|
72421637|NCT03338621|144354414|SUPERIORITY||Cox Proportional Hazard|2.93|||<|0.001|TWO_SIDED|95.0|2.17|3.96|||Log Rank|||||3.96|2.17|<0.001
72601865|NCT01151345|144733027|SUPERIORITY_OR_OTHER||Adjusted geometric means ratio|83.25|||||TWO_SIDED|90.0|67.08|103.31||||||Natural-log transformed Cmax was analyzed using a mixed effect model with sequence, period, and treatment as fixed effects and participant within sequence as a random effect.||103.31|67.08|
72601866|NCT01129804|144733049|SUPERIORITY|Longitudinal Linear mixed modeling|Slope|0.1|||<|0.04|TWO_SIDED|||||Tested the null hypothesis that slopes of PDA over time would not differ between treatment conditions, as indicated by the significance of the Treatment main effect and Treatment X Time interaction effect, at the level of p \< .05.|Mixed Models Analysis||||Multilevel longitudinal modeling (MLM) with random effects and maximum likelihood estimation (Proc MIXED; SAS Institute, 1999) was used to evaluate the effects of treatment over time for each of the continuously scaled outcome variables described above. The MLM approach was used because it employs maximum likelihood estimation of covariance matrices rather than raw data, allowing us to take advantage of all data collected for anyone randomized to treatment. Each repeated dependent variable was analyzed as a unction of treatment condition, time since intake (in months), and the interaction of treatment condition by time.|||<.04
72601867|NCT00305565|144733084|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.34||||0.803|TWO_SIDED|95.0|-2.34|3.02|||Mixed Models Analysis|||The primary analysis consisted of contrasts comparing High Dose vs. Low Dose and Medium Dose vs. Low Dose averaged over the 4 Acute Phase visits using the Hochberg approach to adjust for multiplicity. If both comparisons involving the Low Dose were significant, then a test of High Dose vs. Medium Dose was evaluated at the P≤0.05 level. The pivotal analysis was performed on the ITT population using the last-observation-carried-forward (LOCF) approach to impute missing data.||3.02|-2.34|0.803
72601868|NCT00305565|144733084|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.33||||0.813|TWO_SIDED|95.0|-2.39|3.05|||Mixed Models Analysis|||The primary analysis consisted of contrasts comparing High Dose vs. Low Dose and Medium Dose vs. Low Dose averaged over the 4 Acute Phase visits using the Hochberg approach to adjust for multiplicity. If both comparisons involving the Low Dose were significant, then a test of High Dose vs. Medium Dose was evaluated at the P≤0.05 level. The pivotal analysis was performed on the ITT population using the last-observation-carried-forward (LOCF) approach to impute missing data.||3.05|-2.39|0.813
72601869|NCT03162328|144733177|SUPERIORITY|||||||0.363|||||||Wilcoxon Signed Ranks Test|||||||0.363
72601870|NCT03162328|144733178|SUPERIORITY|||||||0.291|||||||Wilcoxon Signed Ranks Test|||||||0.291
72601871|NCT00282152|144733188|NON_INFERIORITY|Because the purpose of this trial was to provide preliminary safety and tolerability data, the primary hypothesis was that the DBS+ODT group would not worsen more quickly than the ODT group. The primary endpoint was defined as the time to reach a four-point worsening of the UPDRS-III score following a one week treatment washout as assessed by the blinded rater.||||||0.968|||||||Log Rank|||||||0.968
72601872|NCT00282152|144733189|OTHER|||||||0.4|||||||t-test, 2 sided|||Study power was calculated based on the amount of PD medication consumed. We anticipated that the control group (ODT) would have a baseline value of 400 which would increase to 600, and that the treated group (DBS+ODT) would decrease from 400 to 300. A sample size of 12 patients per group (n=15, assuming 20% drop out) would have 80% power to detect a difference in means of 300 assuming that the common standard deviation is 250 using a two group t-test with a 0.05 two-sided significance level.||||0.40
72601873|NCT01124370|144733235|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||The test was conducted using a 0.05 level of significance.|t-test, 2 sided|||The null hypothesis was that there would be no change in AHI from baseline.||||<.001
72601874|NCT02182830|144733242|SUPERIORITY|A hierarchical multiple testing procedure was used to evaluate superiority of the primary endpoint|Adjusted mean difference|-0.78|STANDARD_ERROR_OF_MEAN|0.2||0.0002|TWO_SIDED|95.0|-1.18|-0.38|||Mixed Models Analysis||Empagliflozin minus Placebo|"MMRM model : HbA1c baseline, treatment, renal function, pre-treatment with metformin, visit, visit by treatment interaction, and HbA1c baseline by treatment interaction. Treatment, renal function, pre-treatment with metformin, visit, and visit by treatment interaction were fixed classification effects, and HbA1c baseline was a linear covariate. The interaction visit by HbA1c baseline interaction was based on the linear covariate HbA1c baseline."||-0.38|-1.18|0.0002
72601875|NCT02182830|144733243|SUPERIORITY|A hierarchical multiple testing procedure was used to evaluate superiority of the endpoint|Adjusted mean difference|-5.21|STANDARD_ERROR_OF_MEAN|2.04||0.0117|TWO_SIDED|95.0|-9.24|-1.18|||ANCOVA||Empagliflozin minus Placebo|"change from baseline in mean 24-hour ambulatory SBP at 12 weeks of treatment was evaluated by using an Analysis of Covariance (ANCOVA) model.~The respective model included treatment, renal function, pretreatment with metformin, continuous baseline HbA1c, and continuous baseline of the endpoint."||-1.18|-9.24|0.0117
72601876|NCT02182830|144733244|SUPERIORITY|A hierarchical multiple testing procedure was used to evaluate superiority of the endpoint|Adjusted mean difference|-5.99|STANDARD_ERROR_OF_MEAN|2.62||0.0237|TWO_SIDED|95.0|-11.16|-0.81|||ANCOVA||Empagliflozin minus Placebo|"ANCOVA mode:~The respective model included treatment, renal function, pretreatment with metformin, continuous baseline HbA1c, and continuous baseline of the endpoint."||-0.81|-11.16|0.0237
72601877|NCT02182830|144733245|SUPERIORITY|A hierarchical multiple testing procedure was used to evaluate superiority of the endpoint|Adjusted mean difference|-1.23|STANDARD_ERROR_OF_MEAN|0.59||0.0382|TWO_SIDED|95.0|-2.39|-0.07|||Mixed Models Analysis||Empagliflozin minus Placebo|MMRM models modelling the key secondary endpoint with continuous baseline HbA1c, continuous baseline key secondary endpoint, treatment, renal function, pretreatment with metformin, visit, visit by treatment interaction, visit by continuous baseline HbA1c interaction, visit by continuous baseline key secondary endpoint.||-0.07|-2.39|0.0382
72601878|NCT02182830|144733246|SUPERIORITY|A hierarchical multiple testing procedure was used to evaluate superiority of the endpoint|Adjusted mean difference|-4.04|STANDARD_ERROR_OF_MEAN|2.59||0.1215|TWO_SIDED|95.0|-9.16|1.09|||Mixed Models Analysis||Empagliflozin minus Placebo|MMRM models modelling the key secondary endpoint with continuous baseline HbA1c, continuous baseline key secondary endpoint, treatment, renal function, pretreatment with metformin, visit, visit by treatment interaction, visit by continuous baseline HbA1c interaction, visit by continuous baseline key secondary endpoint.||1.09|-9.16|0.1215
72601879|NCT02182830|144733247|SUPERIORITY||Adjusted mean difference|-8.39|STANDARD_ERROR_OF_MEAN|2.69||0.0025|TWO_SIDED|95.0|-13.74|-3.04|||Mixed Models Analysis||Empagliflozin minus Placebo|MMRM models modelling the secondary endpoint with continuous baseline HbA1c, continuous baseline secondary endpoint, treatment, renal function, pretreatment with metformin, visit, visit by treatment interaction, visit by continuous baseline HbA1c interaction, visit by continuous baseline secondary endpoint.||-3.04|-13.74|0.0025
72601880|NCT02182830|144733248|SUPERIORITY||Adjusted mean difference|-3.43|STANDARD_ERROR_OF_MEAN|1.25||0.0069|TWO_SIDED|95.0|-5.9|-0.96|||ANCOVA||Empagliflozin minus Placebo|The respective ANCOVA model includes treatment, renal function, pretreatment with metformin, continuous baseline HbA1c, and continuous baseline of the respective secondary endpoint.||-0.96|-5.90|0.0069
72601881|NCT02182830|144733249|SUPERIORITY||Adjusted mean difference|-4.91|STANDARD_ERROR_OF_MEAN|1.74||0.0058|TWO_SIDED|95.0|-8.35|-1.46|||Mixed Models Analysis||Empagliflozin minus Placebo|MMRM models modelling the secondary endpoint with continuous baseline HbA1c, continuous baseline secondary endpoint, treatment, renal function, pretreatment with metformin, visit, visit by treatment interaction, visit by continuous baseline HbA1c interaction, visit by continuous baseline secondary endpoint.||-1.46|-8.35|0.0058
72601882|NCT02182830|144733250|SUPERIORITY||Adjusted mean difference|-7.43|STANDARD_ERROR_OF_MEAN|2.5||0.0036|TWO_SIDED|95.0|-12.37|-2.48|||Mixed Models Analysis||Empagliflozin minus Placebo|MMRM models modelling the secondary endpoint with continuous baseline HbA1c, continuous baseline secondary endpoint, treatment, renal function, pretreatment with metformin, visit, visit by treatment interaction, visit by continuous baseline HbA1c interaction, visit by continuous baseline secondary endpoint.||-2.48|-12.37|0.0036
72601883|NCT02182830|144733251|SUPERIORITY||Adjusted mean difference|-1.84|STANDARD_ERROR_OF_MEAN|1.56||0.2402|TWO_SIDED|95.0|-4.93|1.25|||Mixed Models Analysis||Empagliflozin minus Placebo|MMRM models modelling the secondary endpoint with continuous baseline HbA1c, continuous baseline secondary endpoint, treatment, renal function, pretreatment with metformin, visit, visit by treatment interaction, visit by continuous baseline HbA1c interaction, visit by continuous baseline secondary endpoint.||1.25|-4.93|0.2402
72601884|NCT02182830|144733252|SUPERIORITY||Adjusted mean difference|-4.25|STANDARD_ERROR_OF_MEAN|1.49||0.0053|TWO_SIDED|95.0|-7.21|-1.29|||Mixed Models Analysis||Empagliflozin minus Placebo|MMRM models modelling the secondary endpoint with continuous baseline HbA1c, continuous baseline secondary endpoint, treatment, renal function, pretreatment with metformin, visit, visit by treatment interaction, visit by continuous baseline HbA1c interaction, visit by continuous baseline secondary endpoint.||-1.29|-7.21|0.0053
72601885|NCT04672044|144733266|SUPERIORITY|||||||0.896|||||||Wilcoxon (Mann-Whitney)|||||||0.896
72601886|NCT03268005|144733272|NON_INFERIORITY|The upper limit of the 95% confidence interval for the difference between faster aspart and NovoRapid was compared to a non-inferiority margin of 0.4%. If it was below or equal to 0.4% non-inferiority was considered established and effect demonstrated.|Treatment difference|-0.04||||0.31|TWO_SIDED|95.0|-0.11|0.03|||ANOVA||Faster aspart-NovoRapid|Change from baseline in HbA1c was analysed using an analysis of variance model after multiple imputation assuming treatment according to randomisation. The model included treatment, region and metformin use at baseline (Yes/No) as factors, and baseline HbA1c as a covariate.||0.03|-0.11|0.310
72601887|NCT00792116|144733331|NON_INFERIORITY_OR_EQUIVALENCE|||||||0.05||95.0|||||ANCOVA|Repeated Measures||||||.05
72601888|NCT00792116|144733332|NON_INFERIORITY_OR_EQUIVALENCE|||||||0.05||95.0|||||ANCOVA|Repeated Measures||||||.05
72601889|NCT01680653|144733359|SUPERIORITY_OR_OTHER|||||||0.106||||||In analyzing prolonged events on remote monitoring versus control, we used x squared analysis or Fisher's exact test to analyze data on 2 x 2 contingency tables. Significance was defined as P\<0.05.|Wilcoxon (Mann-Whitney)|||The study was a feasibility and preliminary safety study. As such, the sample size was not statistically derived and the protocol was not powered to provide for definitive conclusions. The study was limited to 20 participants at each camp session. A hypoglycemic event was defined as at least two consecutive CGM readings (10 mins) below the hypoglycemic threshold of \<70 mg/dL. Recovery from a hypoglycemic event required readings above threshold for \> or = 25 minutes.||||0.106
72601890|NCT01680653|144733360|SUPERIORITY_OR_OTHER|||||||0.078|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.078
72601891|NCT01680653|144733361|SUPERIORITY_OR_OTHER||Fisher's exact test|||||0.003|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||This is the P value for the number of events \<70 mg/dL longer than one hour||||0.003
72601892|NCT01680653|144733361|SUPERIORITY_OR_OTHER|||||||0.01|TWO_SIDED||||||Fisher's exact test|||This is the p value for the number of events \<70 mg/dL that were greater than 2 hours||||0.010
72601893|NCT01680653|144733361|SUPERIORITY_OR_OTHER|||||||0.021|TWO_SIDED||||||Fisher's exact test|||This is the p value for the number of events that were \<50 mg/dL for \> 30 minutes||||0.021
72601894|NCT01680653|144733361|SUPERIORITY_OR_OTHER|||||||0.077|TWO_SIDED||||||Fisher's exact|||This is the P value for the number of events \<50 mg/dL that were \>1 hr||||0.077
72601895|NCT03020550|144733393|SUPERIORITY|||||||0.034|||||||ANOVA|Adjusted for baseline GERD symptom severity.||The outcome measure was calculated using a general linear model with average daily post GERD symptom severity as the dependent variable with the following independent variables: baseline average GERD symptom severity and change in GSR (galvanic skin response). No term for visit type assignment was included in the model.||||0.034
72601896|NCT03020550|144733394|SUPERIORITY|||||||0.56|||||||ANOVA|Adjusted for baseline GERD symptom severity||The outcome measure was calculated using a general linear model with average daily post GERD symptom severity as the dependent variable with the following independent variables: baseline average GERD symptom severity and change in RMSSD (high frequency HRV). No term for visit type assignment was included in the model.||||0.56
72601897|NCT03020550|144733395|SUPERIORITY|||||||0.8|||||||Pearson's correlation test|||The outcome measure was calculated using a Pearson correlation to compare the session index representing the amount of concordance in GSR between patient and physician and the percent change in patients' GERD symptoms. Visit type assignment was not included in the analysis.||||0.80
72601898|NCT00905567|144733414|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA was performed on ln-transformed AUC0-t, AUC0-72h, and Cmax. All analyses were performed according to FDA's guidleines.|Ratio of the Least Squares Mean|93.01||||||90.0|||||||Bioequivalence is established when Ratio of the Least Squares Mean (test/reference x 100) falls within 80-125.|||||
72601899|NCT00905567|144733415|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA was performed on ln-transformed AUC0-t, AUC0-72h, and Cmax. All analyses were performed according to FDA's guidleines.|Ratio of the Least Squares Mean|96.62||||||90.0|||||||Bioequivalence is established when the Ratio of the Least Squares Mean (test/reference x 100) falls within 80-125.|||||
72601900|NCT00905567|144733416|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA was performed on ln-transformed AUC0-t, AUC0-72h, and Cmax. All analyses were performed according to FDA's guidleines.|Ratio of the Least Squares Mean|96.43||||||90.0|||||||Bioequivalence is established when the Ratio of the Least Squares Mean (test/reference x 100) falls within 80-125.|||||
72601901|NCT02542397|144733417|SUPERIORITY|"It has been reported that, based on the Edmonton Symptom Assessment Scale (ESAS) pain scale, about 30% of cancer patients receiving standard of care pain management experienced \>= 2-point improvement in pain score between visits \[Ref\].~Ref: Scharpf, J., et al., The role of pain in head and neck cancer recurrence and survivorship. Arch Otolaryngol Head Neck Surg, 2009. 135(8): p. 789-94."|Exact binomial proportion|0.5556|||<|0.0001|TWO_SIDED|95.0|0.414|0.6908||The a priori threshold for statistical significance was alpha = 0.10.|Exact binomial test of proportions|||A single-stage design was used to test the hypothesis that the pain improvement rate, assessed by the Edmonton Symptom Assessment Scale, is \<= 0.30. Our study targeted enrollment of 71 evaluable subjects for the final analysis; 54 subjects met the criteria at study closure. Assuming a one-sided alpha=0.10 significance level, 71 evaluable subjects would provide approximately 90% power to reject the null hypothesis (based on an exact binomial test) assuming the true pain improvement rate is 0.45.||.6908|.4140|<0.0001
72552509|NCT01811953|144635831|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMean), test/reference, for the primary endpoints using an acceptance range of 80.00 to 125.00%.|Geometric mean ratio|99.31|STANDARD_ERROR_OF_MEAN|1.04|<|0.0001|TWO_SIDED|90.0|92.14|107.03|||ANOVA||The geometric mean ratio was calculated as the geometric mean of '2 Empagliflozin/Metformin (T)' divided by the geometric mean of '4 Empagliflozin + Metformin (R)'.|||107.03|92.14|<0.0001
72552510|NCT01811953|144635831|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMean), test/reference, for the primary endpoints using an acceptance range of 80.00 to 125.00%.|Geometric mean ratio|100.74|STANDARD_ERROR_OF_MEAN|1.03|<|0.0001|TWO_SIDED|90.0|95.77|105.96|||ANOVA||The geometric mean ratio was calculated as the geometric mean of '5 Empagliflozin/Metformin (T)' divided by the geometric mean of '6 Empagliflozin + Metformin (R)'.|||105.96|95.77|<0.0001
72552511|NCT02262377|144635834|SUPERIORITY|The ITT analysis was done for 21 week average pain.|Risk Ratio (RR)|1.03||||0.68|TWO_SIDED|95.0|0.92|1.15||Statistical significance was set at p\< 0.05.|Regression, Poisson|||Intention to Treat Analysis for average chronic pain.||1.15|0.92|0.68
72601902|NCT04846270|144733477|OTHER|||||||0.0006|||||||Wilcoxon (Mann-Whitney)|A Wilcoxon Signed-Rank test was used to test if the number of manual checks has been reduced.||"POWER is a single arm investigation with cross-over design. Each participating subject will use the study device and act as its own control.~The null hypothesis (H0) is that there is no difference in the mean number of checks performed during the investigation week compared to the baseline week.~The alternate hypothesis (H1) is that there is a reduction in the mean number of checks performed during the investigation week compared to the baseline week."||||0.0006
72601903|NCT04846270|144733479|OTHER|||||||0.0051|||||||Wilcoxon (Mann-Whitney)|A Wilcoxon Signed-Rank test was used to test if the number of leakages had been reduced.||||||0.0051
72601904|NCT04846270|144733482|OTHER|||||||0.76|||||||Wilcoxon (Mann-Whitney)|A Wilcoxon Signed-Rank test was used to test if the number of fecal incidents had been reduced.||||||0.76
72601905|NCT00828061|144733489|SUPERIORITY_OR_OTHER||Geometric Mean Fold Difference|0.25||||0.002||95.0|0.12|0.54||1-sided, alpha = 0.05|ANOVA|Analysis performed on log-transformed fold change from baseline and results were back-transformed for reporting.||||0.54|0.12|0.002
72601906|NCT00828061|144733489|SUPERIORITY_OR_OTHER||Geometric Mean Fold Difference|0.07|||<|0.001||95.0|0.03|0.15||1-sided, alpha = 0.05|ANOVA|Analysis performed on log-transformed fold change from baseline and results were back-transformed for reporting.||||0.15|0.03|<0.001
72601907|NCT00828061|144733490|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.89||||0.537||95.0|-15.48|17.26||1-sided, alpha = 0.05|ANOVA|||||17.26|-15.48|0.537
72601908|NCT01400906|144733491|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.172|||||TWO_SIDED|95.0|-0.037|0.38|||||The estimated value is an adjusted mean difference. Data were adjusted for the following covariates: period, smoking status, treatment, participant-level Baseline, period-level Baseline, and treatment by smoking status interaction.|||0.380|-0.037|
72601909|NCT01400906|144733491|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.161|||||TWO_SIDED|95.0|-0.047|0.37|||||The estimated value is an adjusted mean difference. Data were adjusted for the following covariates: period, smoking status, treatment, participant-level Baseline, period-level Baseline, and treatment by smoking status interaction.|||0.370|-0.047|
72601910|NCT01400906|144733496|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.638|||||TWO_SIDED|95.0|0.44|0.836|||||The estimated value is an adjusted mean difference. Data were adjusted for the following covariates: period, smoking status, treatment, participant-level Baseline, period-level Baseline, and treatment by smoking status interaction.|||0.836|0.440|
72601911|NCT01400906|144733496|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.661|||||TWO_SIDED|95.0|0.463|0.859|||||The estimated value is an adjusted mean difference. Data were adjusted for the following covariates: period, smoking status, treatment, participant-level Baseline, period-level Baseline, and treatment by smoking status interaction.|||0.859|0.463|
72601912|NCT01400906|144733497|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.175|||||TWO_SIDED|95.0|0.018|0.333|||||The estimated value is an adjusted mean difference. Data were adjusted for the following covariates: period, smoking status, treatment, participant-level Baseline, period-level Baseline, and treatment by smoking status interaction.|||0.333|0.018|
72601913|NCT01400906|144733497|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.165|||||TWO_SIDED|95.0|0.008|0.323|||||The estimated value is an adjusted mean difference. Data were adjusted for the following covariates: period, smoking status, treatment, participant-level Baseline, period-level Baseline, and treatment by smoking status interaction.|||0.323|0.008|
72601914|NCT01400906|144733498|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.476|||||TWO_SIDED|95.0|0.326|0.627|||||The estimated value is an adjusted mean difference. Data were adjusted for the following covariates: period, smoking status, treatment, participant-level Baseline, period-level Baseline, and treatment by smoking status interaction.|||0.627|0.326|
72601915|NCT01400906|144733498|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.53|||||TWO_SIDED|95.0|0.38|0.68|||||The estimated value is an adjusted mean difference. Data were adjusted for the following covariates: period, smoking status, treatment, participant-level Baseline, period-level Baseline, and treatment by smoking status interaction.|||0.680|0.380|
72601916|NCT02384538|144733520|OTHER||LS Mean Difference|1.52||||0.386|TWO_SIDED|95.0|-1.944|4.99||P-value for test of difference in change from baseline between ABT-981 dose group and placebo is from an ANCOVA model with treatment group and country as the main factors and baseline as a covariate.|ANCOVA|||||4.990|-1.944|0.386
72601917|NCT02384538|144733522|OTHER||LS Mean Difference|2.55||||0.383|TWO_SIDED|95.0|-3.214|8.308||P-value for test of difference in change from baseline between ABT-981 dose group and placebo is from an ANCOVA model with treatment group and country as the main factors and baseline as a covariate.|ANCOVA|||Week 16||8.308|-3.214|0.383
72601918|NCT02384538|144733523|OTHER||LS Mean Difference|0.15||||0.719|TWO_SIDED|95.0|-0.677|0.979||P-value for test of difference in change from baseline between ABT-981 dose group and placebo is from an ANCOVA model with treatment group and country as the main factors and baseline as a covariate.|ANCOVA|||Week 16||0.979|-0.677|0.719
72601919|NCT02384538|144733524|OTHER||LS Mean Difference|4.25||||0.387|TWO_SIDED|95.0|-5.448|13.945||P-value for test of difference in change from baseline between ABT-981 dose group and placebo is from an ANCOVA model with treatment group and country as the main factors and baseline as a covariate.|ANCOVA|||Week 16||13.945|-5.448|0.387
72601920|NCT02384538|144733525|OTHER||LS Mean Difference|0.45||||0.281|TWO_SIDED|95.0|-0.373|1.272||P-value for test of difference in change from baseline between ABT-981 dose group and placebo is from an ANCOVA model with treatment group and country as the main factors and baseline as a covariate.|ANCOVA|||Week 16||1.272|-0.373|0.281
72601921|NCT02384538|144733526|OTHER||LS Mean Difference|0.52||||0.212|TWO_SIDED|95.0|-0.3|1.336||P-value for test of difference in change from baseline between ABT-981 dose group and placebo is from an ANCOVA model with treatment group and country as the main factors and baseline as a covariate.|ANCOVA|||Week 16||1.336|-0.300|0.212
72601922|NCT02872909|144733527|SUPERIORITY||Mean Difference (Final Values)|1.37|||<|0.05|TWO_SIDED|95.0|0.71|2.54||calculated as \<0.05 for 85% power|t-test, 2 sided|Analysed on log transformed data||Sample size requirement estimation - Preliminary data showed pain scores of 1.25 with ambulatory PDT (n=12) and 5.26 (SD 2.38) for conventional PDT (n=50). Estimated that for 85% power to detect as significant at 5% level a difference in mean pain score in one group of 2cm compared with 4 cm in the other group, assuming two-sided testing, a minimum of 45 subjects needed. We aimed for 50 subjects, with an allocation ratio of 2 (twice as many randomised to ambulatory PDT as conventional PDT)||2.54|0.71|<0.05
72601923|NCT02872909|144733530|SUPERIORITY||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
72601924|NCT03280056|144733561|SUPERIORITY||Odds Ratio (OR)|1.33||||0.453|TWO_SIDED|95.0|0.632|2.798|||Chi-squared|||||2.798|0.632|0.453
72601925|NCT03280056|144733562|SUPERIORITY||Odds Ratio (OR)|0.998||||0.997|TWO_SIDED|95.0|0.416|2.395|||Chi-squared|||||2.395|0.416|0.997
72601926|NCT03280056|144733563|SUPERIORITY||Mean Difference (Final Values)|0.37|STANDARD_ERROR_OF_MEAN|0.926||0.693|TWO_SIDED|95.0|-1.47|2.2|||Mixed Models Analysis|||||2.20|-1.47|0.693
72601927|NCT03280056|144733564|SUPERIORITY||Mean Difference (Final Values)|1.53|STANDARD_ERROR_OF_MEAN|6.176||0.804|TWO_SIDED|95.0|-10.65|13.72|||ANCOVA|||||13.72|-10.65|0.804
72601928|NCT02144077|144733565|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority margin of -15%|Difference in Percentage|1.6|||<|0.0001|ONE_SIDED|97.5|-6.5||||Farrington and Manning Test|Difference of proportions|||||-6.5|<0.0001
72601929|NCT00169104|144733599|SUPERIORITY||Mean Difference (Net)|-0.2|||>|0.05|TWO_SIDED|||||t=-0.29|t-test, 2 sided|df=15||T test||||>0.05
72601930|NCT00141518|144733622|SUPERIORITY_OR_OTHER||mean change from baseline|-9.4|STANDARD_DEVIATION|17.5||0.017|TWO_SIDED||||||Wilcoxon tests|||Total Score, Change From Baseline for the Duodopa Naïve group at Month 12 (n=25)||||0.017
72601931|NCT00141518|144733623|SUPERIORITY_OR_OTHER||mean change from baseline|0.02|STANDARD_DEVIATION|0.29||0.919|TWO_SIDED||||||Wilcoxon tests|||Change from Baseline for the Duodopa Naïve group at Month 12 (n=25)||||0.919
72601932|NCT00141518|144733624|SUPERIORITY_OR_OTHER||mean change from baseline|0.18|STANDARD_DEVIATION|0.24||0.002|TWO_SIDED||||||Wilcoxon tests|||Change from Baseline for the Duodopa Naïve group at Month 12 (n=25)||||0.002
72601933|NCT00141518|144733651|SUPERIORITY_OR_OTHER||mean change from baseline|-6.5|STANDARD_DEVIATION|9.6||0.001|TWO_SIDED||||||Wilcoxon tests|||Change from Baseline for the Duodopa Naïve group at Month 0 (n=27)||||0.001
72601934|NCT00141518|144733651|SUPERIORITY_OR_OTHER||mean change from baseline|-9.2|STANDARD_DEVIATION|9.0|<|0.001|TWO_SIDED||||||Wilcoxon tests|||Change from Baseline for the Duodopa Naïve group at Month 3 (n=23)||||<0.001
72601935|NCT00141518|144733651|SUPERIORITY_OR_OTHER||mean change from baseline|-5.9|STANDARD_DEVIATION|11.2||0.022|TWO_SIDED||||||Wilcoxon tests|||Change from Baseline for the Duodopa Naïve group at Month 6 (n=24)||||0.022
72601936|NCT00141518|144733651|SUPERIORITY_OR_OTHER||mean change from baseline|-7.5|STANDARD_DEVIATION|11.6||0.005|TWO_SIDED||||||Wilcoxon tests|||Change from Baseline for the Duodopa Naïve group at Month 9 (n=23)||||0.005
72601937|NCT00141518|144733651|SUPERIORITY_OR_OTHER||mean change from baseline|-5.3|STANDARD_DEVIATION|13.9||0.126|TWO_SIDED||||||Wilcoxon tests|||Change from Baseline for the Duodopa Naïve group at Month 12 (n=23)||||0.126
72601938|NCT00141518|144733651|SUPERIORITY_OR_OTHER||mean change from baseline|-5.2|STANDARD_DEVIATION|12.3||0.049|TWO_SIDED||||||Wilcoxon tests|||Change from Baseline for the Duodopa Naïve group at Month 18 (n=22)||||0.049
72601939|NCT00141518|144733651|SUPERIORITY_OR_OTHER||mean change from baseline|-3.1|STANDARD_DEVIATION|9.9||0.203|TWO_SIDED||||||Wilcoxon tests|||Change from Baseline for the Duodopa Naïve group at Month 24 (n=21)||||0.203
72601940|NCT00141518|144733651|SUPERIORITY_OR_OTHER||mean change from baseline|0.8|STANDARD_DEVIATION|13.2||0.733|TWO_SIDED||||||Wilcoxon tests|||Change from Baseline for the Duodopa Naïve group at Month 30 (n=21)||||0.733
72601941|NCT00141518|144733651|SUPERIORITY_OR_OTHER||mean change from baseline|4.4|STANDARD_DEVIATION|14.3||0.414|TWO_SIDED||||||Wilcoxon tests|||Change from Baseline for the Duodopa Naïve group at Month 36 (n=20)||||0.414
72601942|NCT00141518|144733651|SUPERIORITY_OR_OTHER||mean change from baseline|2.3|STANDARD_DEVIATION|14.9||0.534|TWO_SIDED||||||Wilcoxon tests|||Change from Baseline for the Duodopa Naïve group at Endpoint (n=27)||||0.534
72601943|NCT00141518|144733660|SUPERIORITY_OR_OTHER|||||||0.016|||||||Wilcoxon tests|||Change from Baseline to Month 12 for morning scores||||0.016
72601944|NCT00141518|144733660|SUPERIORITY_OR_OTHER|||||||0.188|||||||Wilcoxon tests|||Change from Baseline to Month 12 for day scores||||0.188
72601945|NCT00141518|144733661|SUPERIORITY_OR_OTHER|||||||0.008|||||||Wilcoxon tests|||Change from Baseline to Month 12 for morning scores||||0.008
72601946|NCT00141518|144733661|SUPERIORITY_OR_OTHER|||||||0.107|||||||Wilcoxon tests|||Change from Baseline to Month 12 for day scores||||0.107
72601947|NCT00141518|144733662|SUPERIORITY_OR_OTHER|||||||0.002|||||||Wilcoxon tests|||Change from Baseline to Month 12 for morning scores||||0.002
72601948|NCT00141518|144733662|SUPERIORITY_OR_OTHER|||||||0.01|||||||Wilcoxon tests|||Change from Baseline to Month 12 for day scores||||0.010
72601949|NCT00141518|144733663|SUPERIORITY_OR_OTHER|||||||0.048|||||||Wilcoxon tests|||Change from Baseline to Month 12 for morning scores||||0.048
72601950|NCT00141518|144733663|SUPERIORITY_OR_OTHER|||||||0.003|||||||Wilcoxon tests|||Change from Baseline to Month 12 for day scores||||0.003
72601951|NCT00141518|144733664|SUPERIORITY_OR_OTHER|||||||0.001|||||||Wilcoxon tests|||Change from Baseline to Month 12 for morning scores||||0.001
72601952|NCT00141518|144733664|SUPERIORITY_OR_OTHER|||||||0.003|||||||Wilcoxon tests|||Change from Baseline to Month 12 for day scores||||0.003
72601953|NCT00141518|144733665|SUPERIORITY_OR_OTHER|||||||1|||||||Wilcoxon tests|||Change from Baseline to Month 12 for morning scores||||1.000
72601954|NCT00141518|144733665|SUPERIORITY_OR_OTHER|||||||0.002|||||||Wilcoxon tests|||Change from Baseline to Month 12 for day scores||||0.002
72601955|NCT00141518|144733666|SUPERIORITY_OR_OTHER|||||||0.017|||||||Wilcoxon tests|||Change from Baseline to Month 12 for morning scores||||0.017
72601956|NCT00141518|144733666|SUPERIORITY_OR_OTHER|||||||0.191|||||||Wilcoxon tests|||||||0.191
72601957|NCT00141518|144733667|SUPERIORITY_OR_OTHER|||||||0.002|||||||Wilcoxon tests|||Change from Baseline to Month 12 for morning scores||||0.002
72601958|NCT00141518|144733667|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon tests|||Change from Baseline to Month 12 for day scores||||<0.001
72601959|NCT00141518|144733668|SUPERIORITY_OR_OTHER|||||||0.047|||||||Wilcoxon tests|||Change from Baseline to Month 12 for morning scores||||0.047
72601960|NCT00141518|144733668|SUPERIORITY_OR_OTHER|||||||0.847|||||||Wilcoxon tests|||Change from Baseline to Month 12 for day scores||||0.847
72601961|NCT00141518|144733669|SUPERIORITY_OR_OTHER|||||||0.012|||||||Wilcoxon tests|||Change from Baseline to Month 12 for morning scores||||0.012
72601962|NCT00141518|144733669|SUPERIORITY_OR_OTHER|||||||0.035|||||||Wilcoxon tests|||Change from Baseline to Month 12 for day scores||||0.035
72601963|NCT00141518|144733670|SUPERIORITY_OR_OTHER|||||||0.599|||||||Wilcoxon tests|||Change from Baseline to Month 12 for morning scores||||0.599
72601964|NCT00141518|144733670|SUPERIORITY_OR_OTHER|||||||0.048|||||||Wilcoxon tests|||Change from Baseline to Month 12 for day scores||||0.048
72601965|NCT00141518|144733671|SUPERIORITY_OR_OTHER|||||||0.026|||||||Wilcoxon tests|||Change from Baseline to Month 12 for morning scores||||0.026
72601966|NCT00141518|144733671|SUPERIORITY_OR_OTHER|||||||0.208|||||||Wilcoxon tests|||Change from Baseline to Month 12 for day scores||||0.208
72601967|NCT00141518|144733672|SUPERIORITY_OR_OTHER|||||||0.01|||||||Wilcoxon tests|||Change from Baseline to Month 12 for morning scores||||0.010
72601968|NCT00141518|144733672|SUPERIORITY_OR_OTHER|||||||0.073|||||||Wilcoxon tests|||Change from Baseline to Month 12 for day scores||||0.073
72601969|NCT00141518|144733673|SUPERIORITY_OR_OTHER|||||||0.048|||||||Wilcoxon tests|||Change from Baseline to Month 12 for morning scores||||0.048
72601970|NCT00141518|144733673|SUPERIORITY_OR_OTHER|||||||0.03|||||||Wilcoxon tests|||Change from Baseline to Month 12 for day scores||||0.030
72601971|NCT00141518|144733674|SUPERIORITY_OR_OTHER|||||||0.208|||||||Wilcoxon tests|||Change from Baseline to Month 12 for morning scores||||0.208
72601972|NCT00141518|144733674|SUPERIORITY_OR_OTHER|||||||0.048|||||||Wilcoxon tests|||Change from Baseline to Month 12 for day scores||||0.048
72601973|NCT01806168|144733682|OTHER|||||||0.046|||||||Mixed Models Analysis|||||||0.046
72601974|NCT01806168|144733682|EQUIVALENCE|a \< 0.05||||||0.021|||||||t-test, 2 sided|||||||0.021
72601975|NCT01806168|144733682|EQUIVALENCE|a \< 0.05||||||0.65|||||||t-test, 2 sided|||||||0.65
72601976|NCT01806168|144733683|OTHER|||||||0.93|||||||Mixed Models Analysis|||To test primary and secondary outcomes, we utilized intention to treat data and linear mixed models with a group random effect. Significance was set to a \< 0.05.||||0.93
72601977|NCT01806168|144733684|OTHER|||||||0.18|||||||Mixed Models Analysis|||||||0.18
72601978|NCT01806168|144733685|OTHER|||||||0.54|||||||Mixed Models Analysis|||||||0.54
72601979|NCT01806168|144733686|OTHER|||||||0.86|||||||Mixed Models Analysis|||||||0.86
72601980|NCT01806168|144733687|OTHER|||||||0.4|||||||Mixed Models Analysis|||||||0.4
72601981|NCT01029262|144733692|SUPERIORITY||Risk Ratio (RR)|10.616|||<|0.001|TWO_SIDED|95.0|2.639|42.702|||Fisher Exact|p-value is from Fisher's exact test to compare lenalidomide treatment group to placebo group||||42.702|2.639|<0.001
72601982|NCT01029262|144733693|SUPERIORITY|||||||1|||||||Fisher Exact|p-value is from Fisher's exact test to compare lenalidomide treatment group to placebo group.||||||1.000
72601983|NCT01029262|144733694|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.0|||<|0.001|TWO_SIDED|95.0|0.0||NA for risk ratio is due to 0 responder in placebo group.|P-value is from Fisher's exact test to compare the lenalidomide arm to the placebo arm.|Fisher Exact||||||0|< 0.001
72601984|NCT01029262|144733695|SUPERIORITY|||||||0.639|TWO_SIDED||||||Log Rank|p-value from log-rank test to compare lenalidomide and placebo.||||||0.639
72601985|NCT01029262|144733696|SUPERIORITY||Risk Ratio (RR)|1.276||||0.252|TWO_SIDED|95.0|0.867|1.877||p-value is from Fisher's exact test to compare the lenalidomide arm to the placebo arm.|Fisher Exact|||||1.877|0.867|0.252
72601986|NCT01029262|144733698|SUPERIORITY|||||||0.864|TWO_SIDED|||||p-value from log-rank test to compare lenalidomide and placebo.|Log Rank|||||||0.864
72601987|NCT01029262|144733699|SUPERIORITY|||||||0.98||||||p-value from log-rank test to compare lenalidomide and placebo.|Log Rank|||||||0.980
72601988|NCT01029262|144733701|SUPERIORITY|||||||0.823|TWO_SIDED||||||Fisher Exact|The p-values are calculated based on the Fisher exact test||Baseline||||0.823
72601989|NCT01029262|144733701|SUPERIORITY|||||||0.371|TWO_SIDED||||||Fisher Exact|The p-values are calculated based on the Fisher exact test||Week 12 (±3 days)||||0.371
72601990|NCT01029262|144733701|SUPERIORITY|||||||0.391|TWO_SIDED||||||Fisher Exact|The p-values are calculated based on the Fisher exact test||Week 24 (±3 days)||||0.391
72601991|NCT01029262|144733701|SUPERIORITY|||||||1|TWO_SIDED||||||Fisher Exact|The p-values are calculated based on the Fisher exact test||Week 36 (±3 days)||||1.000
72601992|NCT01029262|144733701|SUPERIORITY|||||||0.508|TWO_SIDED||||||Fisher Exact|The p-values are calculated based on the Fisher exact test||Week 48 (±3 days)||||0.508
72601993|NCT01029262|144733702|SUPERIORITY|||||||0.323|TWO_SIDED||||||ANOVA|P-value from ANOVA comparison for change from baseline between lenalidomide and placebo adjusted with baseline score.||Week 12||||0.323
72601994|NCT01029262|144733702|SUPERIORITY|||||||0.071|TWO_SIDED|||||P-value from ANOVA comparison for change from baseline between lenalidomide and placebo adjusted with baseline score.|ANOVA|||Week 24||||0.071
72601995|NCT01029262|144733703|SUPERIORITY|||||||0.76|TWO_SIDED|||||P-value from ANOVA comparison for change from baseline between lenalidomide and placebo adjusted with baseline score|ANOVA|||Week 12||||0.760
72601996|NCT01029262|144733703|SUPERIORITY|||||||0.251|TWO_SIDED|||||P-value from ANOVA comparison for change from baseline between lenalidomide and placebo adjusted with baseline score.|ANOVA|||Week 24||||0.251
72601997|NCT01029262|144733704|SUPERIORITY|||||||0.424|TWO_SIDED|||||P-value from ANOVA comparison for change from baseline between lenalidomide and placebo adjusted with baseline score.|ANOVA|||Week 12||||0.424
72601998|NCT01029262|144733704|SUPERIORITY|||||||0.116|TWO_SIDED|||||P-value from ANOVA comparison for change from baseline between lenalidomide and placebo adjusted with baseline score.|ANOVA|||Week 24||||0.116
72601999|NCT01029262|144733705|SUPERIORITY|||||||0.746|TWO_SIDED|||||P-value from ANOVA comparison for change from baseline between lenalidomide and placebo adjusted with baseline score.|ANOVA|||Week 12||||0.746
72602000|NCT01029262|144733705|SUPERIORITY|||||||0.46|TWO_SIDED|||||P-value from ANOVA comparison for change from baseline between lenalidomide and placebo adjusted with baseline score.|ANOVA|||||||0.460
72602001|NCT01029262|144733706|SUPERIORITY|||||||0.265|TWO_SIDED|||||P-value from ANOVA comparison for change from baseline between lenalidomide and placebo adjusted with baseline score.|ANOVA|||Week 12||||0.265
72602002|NCT01029262|144733706|SUPERIORITY|||||||0.047|TWO_SIDED|||||3\]: P-value from ANOVA comparison for change from baseline between lenalidomide and placebo adjusted with baseline score.|ANOVA|||Week 24||||0.047
72602003|NCT01029262|144733707|SUPERIORITY|||||||0.2909|TWO_SIDED|||||P-value is based on a two-sample t-test comparing the difference between treatments.|t-test, 2 sided|||Week 12||||0.2909
72602004|NCT01029262|144733707|SUPERIORITY|||||||0.0759|TWO_SIDED|||||P-value is based on a two-sample t-test comparing the difference between treatments.|t-test, 2 sided|||Week 24||||0.0759
72602005|NCT01029262|144733708|SUPERIORITY|||||||0.6957|TWO_SIDED|||||P-value is based on a two-sample t-test comparing the difference between treatments|t-test, 2 sided|||Week 12||||0.6957
72602006|NCT01029262|144733708|SUPERIORITY|||||||0.1729|TWO_SIDED|||||P-value is based on a two-sample t-test comparing the difference between treatments|t-test, 2 sided|||Week 24||||0.1729
72602007|NCT01029262|144733709|SUPERIORITY|||||||0.3975|TWO_SIDED||||||t-test, 2 sided|P-value is based on a two-sample t-test comparing the difference between treatments.||Week 12||||0.3975
72602008|NCT01029262|144733709|SUPERIORITY|||||||0.1714|TWO_SIDED|||||P-value is based on a two-sample t-test comparing the difference between treatments.|t-test, 2 sided|||Week 24||||0.1714
72602009|NCT01029262|144733710|SUPERIORITY|||||||0.6408|TWO_SIDED|||||P-value is based on a two-sample t-test comparing the difference between treatments.|t-test, 2 sided|||Week 12||||0.6408
72602010|NCT01029262|144733710|SUPERIORITY|||||||0.575|TWO_SIDED|||||P-value is based on a two-sample t-test comparing the difference between treatments.|t-test, 2 sided|||Week 24||||0.5750
72602011|NCT01029262|144733711|SUPERIORITY|||||||0.2848|TWO_SIDED||||||t-test, 2 sided|P-value is based on a two-sample t-test comparing the difference between treatments||Week 12||||0.2848
72602012|NCT01029262|144733711|SUPERIORITY|||||||0.1053|TWO_SIDED|||||P-value is based on a two-sample t-test comparing the difference between treatments|t-test, 1 sided|||Week 24||||0.1053
72602013|NCT01029262|144733712|SUPERIORITY|||||||0.042|TWO_SIDED|||||The P-values are calculated based on Fisher exact test.|Fisher Exact|||Week 12||||0.042
72602014|NCT01029262|144733712|SUPERIORITY|||||||0.448|TWO_SIDED|||||The P-values are calculated based on Fisher exact test.|Fisher Exact|||Week 24||||0.448
72602015|NCT01029262|144733713|SUPERIORITY|||||||0.825|TWO_SIDED|||||The P-values are calculated based on Fisher exact test.|Fisher Exact|||Week 12||||0.825
72602016|NCT01029262|144733713|SUPERIORITY|||||||0.568|TWO_SIDED|||||The P-values are calculated based on Fisher exact test.|Fisher Exact|||Week 24||||0.568
72602017|NCT01029262|144733714|SUPERIORITY|||||||0.119|TWO_SIDED|||||The P-values are calculated based on Fisher exact test.|Fisher Exact|||Week 12||||0.119
72602018|NCT01029262|144733714|SUPERIORITY|||||||0.172|TWO_SIDED|||||The P-values are calculated based on Fisher exact test.|Fisher Exact|||Week 24||||0.172
72602019|NCT01029262|144733715|SUPERIORITY|||||||0.792|TWO_SIDED|||||The P-values were calculated based on Fisher exact test.|Fisher Exact|||Week 12||||0.792
72602020|NCT01029262|144733715|SUPERIORITY|||||||0.279|TWO_SIDED|||||The P-values are calculated based on Fisher exact test.|Fisher Exact|||Week 24||||0.279
72602021|NCT01029262|144733716|SUPERIORITY|||||||0.476|TWO_SIDED|||||The P-values are calculated based on Fisher exact test.|Fisher Exact|||Week 12||||0.476
72602022|NCT01029262|144733716|SUPERIORITY|||||||0.052|TWO_SIDED|||||The P-values are calculated based on Fisher exact test.|Fisher Exact|||Week 24||||0.052
72602023|NCT01029262|144733717|SUPERIORITY||Risk Ratio (RR)|1.759||||0.017|TWO_SIDED|95.0|1.083|2.856||p-value is from Fisher's exact test to compare lenalidomide treatment group to placebo group.|Fisher Exact|||||2.856|1.083|0.017
72602024|NCT03410992|144733728|SUPERIORITY||Odds Ratio (OR)|496.318|||<|0.001|TWO_SIDED|95.0|82.798|2975.086||P-values for the comparison of treatment groups were based on the CMH test from the general association.|Cochran-Mantel-Haenszel|||Odds ratio: Bimekizumab/Placebo calculated using stratified Cochran-Mantel-Haenszel (CMH) test with region and prior biologic exposure as stratification variables.||2975.086|82.798|<0.001
72602025|NCT03410992|144733729|SUPERIORITY||Odds Ratio (OR)|657.255|||<|0.001|TWO_SIDED|95.0|105.792|4083.333||P-values for the comparison of treatment groups were based on the CMH test from the general association.|Cochran-Mantel-Haenszel|||Odds ratio: Bimekizumab/Placebo calculated using stratified Cochran-Mantel-Haenszel (CMH) test with region and prior biologic exposure as stratification variables.||4083.333|105.792|<0.001
72602026|NCT03410992|144733730|SUPERIORITY||Odds Ratio (OR)|220.038|||<|0.001|TWO_SIDED|95.0|28.757|1683.639||P-values for the comparison of treatment groups were based on the CMH test from the general association.|Cochran-Mantel-Haenszel|||Odds ratio: Bimekizumab/Placebo calculated using stratified Cochran-Mantel-Haenszel (CMH) test with region and prior biologic exposure as stratification variables.||1683.639|28.757|<0.001
72602027|NCT03410992|144733731|SUPERIORITY||Odds Ratio (OR)|224.744|||<|0.001|TWO_SIDED|95.0|30.13|1676.425||P-values for the comparison of treatment groups were based on the CMH test from the general association.|Cochran-Mantel-Haenszel|||Odds ratio: Bimekizumab/Placebo calculated using stratified Cochran-Mantel-Haenszel (CMH) test with region and prior biologic exposure as stratification variables.||1676.425|30.130|<0.001
72602028|NCT03410992|144733732|SUPERIORITY||Odds Ratio (OR)|316.641|||<|0.001|TWO_SIDED|95.0|39.423|2543.254||P-values for the comparison of treatment groups were based on the CMH test from the general association.|Cochran-Mantel-Haenszel|||Odds ratio: Bimekizumab/Placebo calculated using stratified Cochran-Mantel-Haenszel (CMH) test with region and prior biologic exposure as stratification variables.||2543.254|39.423|<0.001
72602029|NCT03410992|144733733|SUPERIORITY||Odds Ratio (OR)|34.325|||<|0.001|TWO_SIDED|95.0|14.22|82.856||P-values for the comparison of treatment groups were based on the CMH test from the general association.|Cochran-Mantel-Haenszel|||Odds ratio: Bimekizumab/Placebo calculated using stratified Cochran-Mantel-Haenszel (CMH) test with region and prior biologic exposure as stratification variables.||82.856|14.220|<0.001
72602030|NCT03410992|144733734|SUPERIORITY||Odds Ratio (OR)|43.497|||<|0.001|TWO_SIDED|95.0|15.728|120.295||P-values for the comparison of treatment groups were based on the CMH test from the general association.|Cochran-Mantel-Haenszel|||Odds ratio: Bimekizumab/Placebo calculated using stratified Cochran-Mantel-Haenszel (CMH) test with region and prior biologic exposure as stratification variables.||120.295|15.728|<0.001
72602031|NCT03410992|144733735|SUPERIORITY||Odds Ratio (OR)|60.946|||<|0.001|TWO_SIDED|95.0|20.56|180.669||P-values for the comparison of treatment groups were based on the CMH test from the general association.|Cochran-Mantel-Haenszel|||Odds ratio: Bimekizumab/Placebo calculated using stratified Cochran-Mantel-Haensze (CMH) test with region and prior biologic exposure as stratification variables.||180.669|20.560|<0.001
72602032|NCT03410992|144733736|SUPERIORITY||Odds Ratio (OR)|158.0|||<|0.001|TWO_SIDED|95.0|49.263|506.745||P-values for the comparison of treatment groups were based on the CMH test from the general association.|Cochran-Mantel-Haenszel|||Odds ratio: Bimekizumab/Placebo calculated using stratified Cochran-Mantel-Haenszel (CMH) test with region and prior biologic exposure as stratification variables.||506.745|49.263|<0.001
72602033|NCT03410992|144733737|SUPERIORITY||Odds Ratio (OR)|45.192|||<|0.001|TWO_SIDED|95.0|18.622|109.672||P-values for the comparison of treatment groups were based on the CMH test from the general association.|Cochran-Mantel-Haenszel|||Odds ratio: Bimekizumab/Placebo calculated using stratified Cochran-Mantel-Haenszel (CMH) test with region and prior biologic exposure as stratification variables. This statistical analysis is not controlled for multiplicity and is only nominal.||109.672|18.622|<0.001
72602034|NCT03410992|144733737|SUPERIORITY||Odds Ratio (OR)|49.297|||<|0.001|TWO_SIDED|95.0|18.887|128.673||P-values for the comparison of treatment groups were based on the CMH test from the general association.|Cochran-Mantel-Haenszel|||Odds ratio: Bimekizumab/Placebo calculated using stratified Cochran-Mantel-Haenszel (CMH) test with region and prior biologic exposure as stratification variables. This statistical analysis is not controlled for multiplicity and is only nominal.||128.673|18.887|<0.001
72602035|NCT03410992|144733737|SUPERIORITY||Odds Ratio (OR)|47.406|||<|0.001|TWO_SIDED|95.0|22.087|101.75||P-values for the comparison of treatment groups were based on the CMH test from the general association.|Cochran-Mantel-Haenszel|||Odds ratio: Bimekizumab/Placebo calculated using stratified Cochran-Mantel-Haenszel (CMH) test with region and prior biologic exposure as stratification variables. This statistical analysis is not controlled for multiplicity and is only nominal.||101.750|22.087|<0.001
72602036|NCT03299101|144733773|SUPERIORITY|||||||0.872|||||||Mixed Models Analysis|||Linear mixed models estimated overall, within-person change in grip strength across all 4 time points.||||0.872
72602037|NCT03299101|144733773|SUPERIORITY||Mean Difference (Net)|0.57|STANDARD_ERROR_OF_MEAN|0.71||0.423|TWO_SIDED|||||The null hypothesis was rejected a priori if p\<.05.|Mixed Models Analysis||The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.|Linear mixed models estimated within-person change in grip strength between baseline and day of surgery.||||0.423
72602038|NCT03299101|144733773|SUPERIORITY||Mean Difference (Net)|-0.39|STANDARD_ERROR_OF_MEAN|2.12||0.853|TWO_SIDED|||||The null hypothesis was rejected a priori if p\<.05.|Mixed Models Analysis||The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.|Linear mixed models estimated within-person change in grip strength between baseline and 90 days postop.||||0.853
72602039|NCT03299101|144733773|SUPERIORITY||Mean Difference (Net)|-1.28|STANDARD_ERROR_OF_MEAN|2.16||0.552|TWO_SIDED|||||The null hypothesis was rejected a priori if p\<.05.|Mixed Models Analysis||The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.|Linear mixed models estimated within-person change in grip strength between day of surgery and 90 days postop.||||0.552
72602040|NCT03299101|144733774|SUPERIORITY|||||||0.256||||||The null hypothesis was rejected a priori if p\<.05.|Mixed Models Analysis|||Linear mixed models estimated overall, within-person change in max MIP across all 4 time points.||||0.256
72602041|NCT03299101|144733774|SUPERIORITY||Mean Difference (Net)|4.69|STANDARD_ERROR_OF_MEAN|2.78||0.091|TWO_SIDED|||||The null hypothesis was rejected a priori if p\<.05.|Mixed Models Analysis||The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.|Linear mixed models estimated within-person change in maximum MIP between baseline and day of surgery.||||0.091
72602042|NCT03299101|144733774|SUPERIORITY||Mean Difference (Net)|6.8|STANDARD_ERROR_OF_MEAN|3.69||0.066|TWO_SIDED|||||The null hypothesis was rejected a priori if p\<.05.|Mixed Models Analysis||The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.|Linear mixed models estimated within-person change in maximum MIP between baseline and 90 days postop.||||0.066
72602043|NCT03299101|144733774|SUPERIORITY||Mean Difference (Net)|1.86|STANDARD_ERROR_OF_MEAN|3.13||0.552|TWO_SIDED|||||The null hypothesis was rejected a priori if p\<.05.|Mixed Models Analysis||The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.|Linear mixed models estimated within-person change in maximum MIP between day of surgery and 90 days postop.||||0.552
72602044|NCT03299101|144733775|SUPERIORITY|||||||0.003||||||The null hypothesis was rejected a priori if p\<.05.|Mixed Models Analysis|||Linear mixed models estimated overall, within-person change in mean MIP across all 4 time points.||||0.003
72602045|NCT03299101|144733775|SUPERIORITY||Mean Difference (Net)|7.48|STANDARD_ERROR_OF_MEAN|2.48||0.003|TWO_SIDED|||||The null hypothesis was rejected a priori if p\<.05.|Mixed Models Analysis||The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.|Linear mixed models estimated within-person change in mean MIP between baseline and day of surgery.||||0.003
72602046|NCT03299101|144733775|SUPERIORITY||Mean Difference (Net)|10.18|STANDARD_ERROR_OF_MEAN|3.61||0.005|TWO_SIDED|||||The null hypothesis was rejected a priori if p\<.05.|Mixed Models Analysis||The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.|Linear mixed models estimated within-person change in mean MIP between baseline and 90 days postop.||||0.005
72602047|NCT03299101|144733775|SUPERIORITY||Mean Difference (Net)|2.31|STANDARD_ERROR_OF_MEAN|2.18||0.29|TWO_SIDED|||||The null hypothesis was rejected a priori if p\<.05.|Mixed Models Analysis||The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.|Linear mixed models estimated within-person change in mean MIP between day of surgery and 90 days postop.||||0.290
72602048|NCT03299101|144733776|SUPERIORITY|||||||0.009||||||The null hypothesis was rejected a priori if p\<.05.|Mixed Models Analysis|||Linear mixed models estimated overall, within-person change in maximal inspiratory pressure across all 4 time points.||||0.009
72602049|NCT03299101|144733776|SUPERIORITY||Mean Difference (Net)|12.61|STANDARD_ERROR_OF_MEAN|4.57||0.006|TWO_SIDED|||||The null hypothesis was rejected a priori if p\<.05.|Mixed Models Analysis||The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.|Linear mixed models estimated within-person change in maximum MEP between baseline and day of surgery.||||0.006
72602050|NCT03299101|144733776|SUPERIORITY||Mean Difference (Net)|12.79|STANDARD_ERROR_OF_MEAN|5.25||0.015|TWO_SIDED|||||The null hypothesis was rejected a priori if p\<.05.|Mixed Models Analysis||The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.|Linear mixed models estimated within-person change in maximum MEP between baseline and 90 days postop.||||0.015
72602051|NCT03299101|144733776|SUPERIORITY||Mean Difference (Net)|-0.86|STANDARD_ERROR_OF_MEAN|3.42||0.802|TWO_SIDED|||||The null hypothesis was rejected a priori if p\<.05.|Mixed Models Analysis||The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.|Linear mixed models estimated within-person change in maximum MEP between day of surgery and 90 days postop.||||0.802
72602052|NCT03299101|144733777|SUPERIORITY|||||||0.01||||||The null hypothesis was rejected a priori if p\<.05.|Mixed Models Analysis|||Linear mixed models estimated overall, within-person change in Mean MEP across all 4 time points.||||0.010
72602053|NCT03299101|144733777|SUPERIORITY||Mean Difference (Net)|12.37|STANDARD_ERROR_OF_MEAN|4.35||0.004|TWO_SIDED|||||The null hypothesis was rejected a priori if p\<.05.|Mixed Models Analysis||The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.|Linear mixed models estimated within-person change in mean MEP between baseline and day of surgery.||||0.004
72602054|NCT03299101|144733777|SUPERIORITY||Mean Difference (Net)|9.95|STANDARD_ERROR_OF_MEAN|4.9||0.042|TWO_SIDED|||||The null hypothesis was rejected a priori if p\<.05.|Mixed Models Analysis||The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.|Linear mixed models estimated within-person change in mean MEP between baseline and 90 days postop.||||0.042
72602055|NCT03299101|144733777|SUPERIORITY||Mean Difference (Net)|-3.77|STANDARD_ERROR_OF_MEAN|3.08||0.221|TWO_SIDED|||||The null hypothesis was rejected a priori if p\<.05.|Mixed Models Analysis||The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.|Linear mixed models estimated within-person change in mean MEP between day of surgery and 90 days postop.||||0.221
72602056|NCT03299101|144733778|SUPERIORITY|||||||0.814|||||||Mixed Models Analysis|||Linear mixed models estimated overall, within-person change in max SMIP across all 4 time points.||||0.814
72602057|NCT03299101|144733778|SUPERIORITY||Mean Difference (Net)|10.5|STANDARD_ERROR_OF_MEAN|30.91||0.734|TWO_SIDED|||||The null hypothesis was rejected a priori if p\<.05.|Mixed Models Analysis||The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.|Linear mixed models estimated within-person change in maximum SMIP between baseline and day of surgery.||||0.734
72602058|NCT03299101|144733778|SUPERIORITY||Mean Difference (Net)|21.07|STANDARD_ERROR_OF_MEAN|22.12||0.341|TWO_SIDED|||||The null hypothesis was rejected a priori if p\<.05.|Mixed Models Analysis||The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.|Linear mixed models estimated within-person change in maximum SMIP between baseline and 90 days postop.||||0.341
72602059|NCT03299101|144733778|SUPERIORITY||Mean Difference (Net)|28.55|STANDARD_ERROR_OF_MEAN|37.61||0.448|TWO_SIDED|||||The null hypothesis was rejected a priori if p\<.05.|Mixed Models Analysis||The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.|Linear mixed models estimated within-person change in maximum SMIP between day of surgery and 90 days postop.||||0.448
72602060|NCT03299101|144733779|SUPERIORITY|||||||0.419|||||||Mixed Models Analysis|||Linear mixed models estimated overall, within-person change in mean SMIP across all 4 time points.||||0.419
72602061|NCT03299101|144733779|SUPERIORITY||Mean Difference (Net)|20.91|STANDARD_ERROR_OF_MEAN|27.03||0.439|TWO_SIDED|||||The null hypothesis was rejected a priori if p\<.05.|Mixed Models Analysis||The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.|Linear mixed models estimated within-person change in mean SMIP between baseline and day of surgery.||||0.439
72602062|NCT03299101|144733779|SUPERIORITY||Mean Difference (Net)|47.67|STANDARD_ERROR_OF_MEAN|26.19||0.069|TWO_SIDED|||||The null hypothesis was rejected a priori if p\<.05.|Mixed Models Analysis||The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.|Linear mixed models estimated within-person change in mean SMIP between baseline and 90 days postop.||||0.069
72602063|NCT03299101|144733779|SUPERIORITY||Mean Difference (Net)|37.11|STANDARD_ERROR_OF_MEAN|37.96||0.328|TWO_SIDED|||||The null hypothesis was rejected a priori if p\<.05.|Mixed Models Analysis||The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.|Linear mixed models estimated within-person change in mean SMIP between day of surgery and 90 days postop.||||0.328
72602064|NCT03299101|144733780|SUPERIORITY|||||||0.196|||||||Mixed Models Analysis|||Linear mixed models estimated overall, within-person change in serum prealbumin across all 4 time points.||||0.196
72602065|NCT03299101|144733780|SUPERIORITY||Mean Difference (Net)|-0.11|STANDARD_ERROR_OF_MEAN|0.19||0.562|TWO_SIDED|||||The null hypothesis was rejected a priori if p\<.05.|Mixed Models Analysis||The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.|Linear mixed models estimated within-person change in serum prealbumin between baseline and day of surgery.||||0.562
72602066|NCT03299101|144733780|SUPERIORITY||Mean Difference (Net)|-0.42|STANDARD_ERROR_OF_MEAN|0.25||0.087|TWO_SIDED|||||The null hypothesis was rejected a priori if p\<.05.|Mixed Models Analysis||The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.|Linear mixed models estimated within-person change in serum prealbumin between baseline and 90 days postop.||||0.087
72602067|NCT03299101|144733780|SUPERIORITY||Mean Difference (Net)|-0.28|STANDARD_ERROR_OF_MEAN|0.23||0.226|TWO_SIDED|||||The null hypothesis was rejected a priori if p\<.05.|Mixed Models Analysis||The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.|Linear mixed models estimated within-person change in serum prealbumin between day of surgery and 90 days postop.||||0.226
72602068|NCT03299101|144733781|SUPERIORITY|||||||0.001|||||||Mixed Models Analysis|||Linear mixed models estimated overall, within-person change in gait speed across all 4 time points.||||0.001
72602069|NCT03299101|144733781|SUPERIORITY||Mean Difference (Net)|0.12|STANDARD_ERROR_OF_MEAN|0.04||0.001|TWO_SIDED|||||The null hypothesis was rejected a priori if p\<.05.|Mixed Models Analysis||The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.|Linear mixed models estimated within-person change in gait speed between baseline and day of surgery.||||0.001
72602070|NCT03299101|144733781|SUPERIORITY||Mean Difference (Net)|0.16|STANDARD_ERROR_OF_MEAN|0.05||0.001|TWO_SIDED|||||The null hypothesis was rejected a priori if p\<.05.|Mixed Models Analysis||The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests|Linear mixed models estimated within-person change in gait speed between baseline and 90 days postop.||||0.001
72602071|NCT03299101|144733781|SUPERIORITY||Mean Difference (Net)|0.01|STANDARD_ERROR_OF_MEAN|0.05||0.874|TWO_SIDED|||||The null hypothesis was rejected a priori if p\<.05.|Mixed Models Analysis||The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.|Linear mixed models estimated within-person change in gait speed between day of surgery and 90 days postop.||||0.874
72602072|NCT03299101|144733782|SUPERIORITY|||||||0.854|||||||Mixed Models Analysis|||Linear mixed models estimated overall, within-person change in SPPB across all 4 time points.||||0.854
72602073|NCT03299101|144733782|SUPERIORITY||Mean Difference (Net)|0.33|STANDARD_ERROR_OF_MEAN|0.32||0.298|TWO_SIDED|||||The null hypothesis was rejected a priori if p\<.05.|Mixed Models Analysis||The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.|Linear mixed models estimated within-person change in SPPB between baseline and day of surgery.||||0.298
72602074|NCT03299101|144733782|SUPERIORITY||Mean Difference (Net)|0.13|STANDARD_ERROR_OF_MEAN|0.31||0.684|TWO_SIDED|||||The null hypothesis was rejected a priori if p\<.05.|Mixed Models Analysis||The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.|Linear mixed models estimated within-person change in SPPB between baseline and 90 days postop.||||0.684
72602075|NCT03299101|144733782|SUPERIORITY||Mean Difference (Net)|-0.23|STANDARD_ERROR_OF_MEAN|0.33||0.485|TWO_SIDED|||||The null hypothesis was rejected a priori if p\<.05.|Mixed Models Analysis||The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.|Linear mixed models estimated within-person change in SPPB between day of surgery and 90 days postop.||||0.485
72602076|NCT03299101|144733783|SUPERIORITY|||||||0.067|||||||Mixed Models Analysis|||Linear mixed models estimated overall, within-person change in RAI across all 4 time points.||||0.067
72602077|NCT03299101|144733783|SUPERIORITY||Mean Difference (Net)|2.07|STANDARD_ERROR_OF_MEAN|1.22||0.089|TWO_SIDED|||||The null hypothesis was rejected a priori if p\<.05.|Mixed Models Analysis||The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.|Linear mixed models estimated within-person change in RAI between baseline and day of surgery.||||0.089
72602078|NCT03299101|144733783|SUPERIORITY||Mean Difference (Net)|4.37|STANDARD_ERROR_OF_MEAN|1.6||0.006|TWO_SIDED|||||The null hypothesis was rejected a priori if p\<.05.|Mixed Models Analysis||The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.|Linear mixed models estimated within-person change in RAI between baseline and 90 days postop.||||0.006
72602079|NCT03299101|144733783|SUPERIORITY||Mean Difference (Net)|1.98|STANDARD_ERROR_OF_MEAN|1.62||0.221|TWO_SIDED|||||The null hypothesis was rejected a priori if p\<.05.|Mixed Models Analysis||The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.|Linear mixed models estimated within-person change in RAI between day of surgery and 90 days postop.||||0.221
72602080|NCT03299101|144733784|SUPERIORITY|||||||0.86|||||||Mixed Models Analysis|||Linear mixed models estimated overall, within-person change in SGA across all 4 time points.||||0.860
72602081|NCT03299101|144733784|SUPERIORITY||Mean Difference (Net)|-0.1|STANDARD_ERROR_OF_MEAN|0.12||0.41|TWO_SIDED|||||The null hypothesis was rejected a priori if p\<.05.|Mixed Models Analysis||The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.|Linear mixed models estimated within-person change in SGA between baseline and day of surgery.||||0.410
72602082|NCT03299101|144733784|SUPERIORITY||Mean Difference (Net)|-0.09|STANDARD_ERROR_OF_MEAN|0.17||0.622|TWO_SIDED|||||The null hypothesis was rejected a priori if p\<.05.|Mixed Models Analysis||The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.|Linear mixed models estimated within-person change in SGA between baseline and 90 days postop.||||0.622
72602083|NCT03299101|144733784|SUPERIORITY||Mean Difference (Net)|-0.05|STANDARD_ERROR_OF_MEAN|0.15||0.757|TWO_SIDED|||||The null hypothesis was rejected a priori if p\<.05.|Mixed Models Analysis||The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.|Linear mixed models estimated within-person change in SGA between day of surgery and 90 days postop.||||0.757
72602084|NCT03299101|144733785|SUPERIORITY|||||||0.362|||||||Mixed Models Analysis|||Linear mixed models estimated overall, within-person change in 6 Minute Walk Test across all 4 time points.||||0.362
72602085|NCT03299101|144733785|SUPERIORITY||Mean Difference (Net)|25.52|STANDARD_ERROR_OF_MEAN|20.06||0.203|TWO_SIDED|||||The null hypothesis was rejected a priori if p\<.05.|Mixed Models Analysis||The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.|Linear mixed models estimated within-person change in 6 Minute Walk Test between baseline and day of surgery.||||.203
72602086|NCT03299101|144733785|SUPERIORITY||Mean Difference (Net)|12.7|STANDARD_ERROR_OF_MEAN|13.77||0.357|TWO_SIDED|||||The null hypothesis was rejected a priori if p\<0.05.|Mixed Models Analysis||The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.|Linear mixed models estimated within-person change in 6 Minute Walk Test between baseline and 90 days postop.||||0.357
72602087|NCT03299101|144733785|SUPERIORITY||Mean Difference (Net)|21.48|STANDARD_ERROR_OF_MEAN|15.4||0.163|TWO_SIDED|||||The null hypothesis was rejected a priori if p\<0.05.|Mixed Models Analysis||The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.|Linear mixed models estimated within-person change in 6 Minute Walk Test between day of surgery and 90 days postop.||||0.163
72602088|NCT03299101|144733786|SUPERIORITY|||||||0.068|||||||Mixed Models Analysis|||Linear mixed models estimated overall, within-person change across all 4 time points.||||0.068
72602089|NCT03299101|144733786|SUPERIORITY||Mean Difference (Net)|0.03|STANDARD_ERROR_OF_MEAN|0.02||0.043|TWO_SIDED|||||The null hypothesis was rejected a priori if p\<.05.|Mixed Models Analysis||The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.|Linear mixed models estimated within-person change between baseline and day of surgery.||||0.043
72602090|NCT03299101|144733786|SUPERIORITY||Mean Difference (Net)|0.04|STANDARD_ERROR_OF_MEAN|0.02||0.092|TWO_SIDED|||||The null hypothesis was rejected a priori if p\<.05.|Mixed Models Analysis||The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.|Linear mixed models estimated within-person change between baseline and 90 days postop.||||0.092
72602091|NCT03299101|144733786|SUPERIORITY||Mean Difference (Net)|0.02|STANDARD_ERROR_OF_MEAN|0.02||0.292|TWO_SIDED||||||Mixed Models Analysis|The null hypothesis was rejected a priori if p\<.05.|The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.|Linear mixed models estimated within-person change in mean MEP between day of surgery and 90 days postop.||||0.292
72602092|NCT03299101|144733787|SUPERIORITY|||||||0.625|||||||Mixed Models Analysis|||Linear mixed models estimated overall, within-person change across both time points.||||0.625
72602093|NCT01100723|144733788|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0|||||McNemar|||Number of subjects meeting targets were compared to the same subjects baseline values using the McNemar test for paired longitudinal data. For the 1 year analysis, the proportion of subjects with PTH values in the target range was calculated at 1 year and that was compared to the proportion of the same subjects who were in target at baseline.||||< 0.05
72602094|NCT01100723|144733789|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0|||||McNemar|||Number of subjects meeting targets were compared to the same subjects baseline values using the McNemar test for paired longitudinal data. For the 1 year analysis, the proportion of subjects with phosphorus values in the target range was calculated at 1 year and that was compared to the proportion of the same subjects who were in target at baseline.||||<0.05
72602095|NCT01100723|144733790|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0|||||McNemar|||Number of subjects meeting targets were compared to the same subjects baseline values using the McNemar test for paired longitudinal data. For the 1 year analysis, the proportion of subjects with PTH values in the target range was calculated at 1 year and that was compared to the proportion of the same subjects who were in target at baseline.||||< 0.05
72602096|NCT01100723|144733791|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0|||||McNemar|||Number of subjects meeting targets were compared to the same subjects baseline values using the McNemar test for paired longitudinal data. For the 1 year analysis, the proportion of subjects with phosphorus values in the target range was calculated at 1 year and that was compared to the proportion of the same subjects who were in target at baseline.||||< 0.05
72602097|NCT01100723|144733792|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0|||||McNemar|||Number of subjects meeting targets were compared to the same subjects baseline values using the McNemar test for paired longitudinal data. For the 1 year analysis, the proportion of subjects with Ca values in the target range was calculated at 1 year and that was compared to the proportion of the same subjects who were in target at baseline.||||< 0.05
72602098|NCT01100723|144733793|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0|||||McNemar|||Proportion of subjects on specified medications were compared to the same subjects baseline values using the McNemar test for paired longitudinal data. For the 1 year analysis, the proportion of subjects on the specified medications was calculated at 1 year and that was compared to the proportion of the same subjects who were in target at baseline.||||< 0.05
72602099|NCT00435461|144733803|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9|STANDARD_ERROR_OF_MEAN|0.14|<|0.001|TWO_SIDED|95.0|-1.2|-0.7|||ANCOVA|||||-0.7|-1.2|<0.001
72602100|NCT00435461|144733803|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0|STANDARD_ERROR_OF_MEAN|0.14|<|0.001|TWO_SIDED|95.0|-1.2|-0.7|||ANCOVA|||||-0.7|-1.2|<0.001
72602101|NCT00435461|144733803|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.14||0.816|TWO_SIDED|95.0|-0.3|0.2|||ANCOVA|||||0.2|-0.3|0.816
72602102|NCT00435461|144733804|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.3|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|95.0|-1.6|-0.9|||ANCOVA|||||-0.9|-1.6|<0.001
72602103|NCT00435461|144733804|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|95.0|-1.4|-0.7|||ANCOVA|||||-0.7|-1.4|<0.001
72602104|NCT00435461|144733804|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.18||0.136|TWO_SIDED|95.0|-0.6|0.1|||ANCOVA|||||0.1|-0.6|0.136
72602105|NCT00435461|144733805|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.1|STANDARD_ERROR_OF_MEAN|0.19|<|0.001|TWO_SIDED|95.0|-1.5|-0.7|||ANCOVA|||||-0.7|-1.5|<0.001
72602106|NCT00435461|144733805|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8|STANDARD_ERROR_OF_MEAN|0.19|<|0.001|TWO_SIDED|95.0|-1.2|-0.4|||ANCOVA|||||-0.4|-1.2|<0.001
72602107|NCT00435461|144733805|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.19||0.136|TWO_SIDED|95.0|-0.7|0.1|||ANCOVA|||||0.1|-0.7|0.136
72602108|NCT00435461|144733806|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.2|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|95.0|-1.6|-0.8|||ANCOVA|||||-0.8|-1.6|<0.001
72602109|NCT00435461|144733806|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|95.0|-1.3|-0.6|||ANCOVA|||||-0.6|-1.3|<0.001
72602110|NCT00435461|144733806|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.18||0.136|TWO_SIDED|95.0|-0.6|0.1|||ANCOVA|||||0.1|-0.6|0.136
72602111|NCT00435461|144733807|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|0.15||0.001|TWO_SIDED|95.0|-0.8|-0.2|||ANCOVA|||||-0.2|-0.8|0.001
72602112|NCT00435461|144733807|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.15||0.106|TWO_SIDED|95.0|-0.6|0.0|||ANCOVA|||||0|-0.6|0.106
72602113|NCT00435461|144733807|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.15||0.286|TWO_SIDED|95.0|-0.5|0.1|||ANCOVA|||||0.1|-0.5|0.286
72602114|NCT00435461|144733808|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.15||0.007|TWO_SIDED|95.0|-0.7|-0.1|||ANCOVA|||||-0.1|-0.7|0.007
72602115|NCT00435461|144733808|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.15||0.286|TWO_SIDED|95.0|-0.5|0.1|||ANCOVA|||||0.1|-0.5|0.286
72602116|NCT00435461|144733808|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.15||0.106|TWO_SIDED|95.0|-0.5|0.1|||ANCOVA|||||0.1|-0.5|0.106
72602117|NCT00435461|144733809|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|0.15||0.003|TWO_SIDED|95.0|-0.7|-0.2|||ANCOVA|||||-0.2|-0.7|0.003
72602118|NCT00435461|144733809|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.15||0.286|TWO_SIDED|95.0|-0.5|0.1|||ANCOVA|||||0.1|-0.5|0.286
72602119|NCT00435461|144733809|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.15||0.106|TWO_SIDED|95.0|-0.6|0.0|||ANCOVA|||||0|-0.6|0.106
72602120|NCT00435461|144733810|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.3|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|95.0|-1.7|-1.0|||ANCOVA|||Pre-dose iTNSS||-1|-1.7|<0.001
72602121|NCT00435461|144733810|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.1|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|95.0|-1.4|-0.7|||ANCOVA|||Pre-dose iTNSS||-0.7|-1.4|<0.001
72602122|NCT00435461|144733810|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.18||0.193|TWO_SIDED|95.0|-0.6|0.1|||ANCOVA|||Pre-dose iTNSS||0.1|-0.6|0.193
72602123|NCT00435461|144733810|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|0.15|<|0.001|TWO_SIDED|95.0|-0.8|-0.2|||ANCOVA|||Pre-dose iTOSS||-0.2|-0.8|<0.001
72602124|NCT00435461|144733810|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.15||0.058|TWO_SIDED|95.0|-0.6|0.0|||ANCOVA|||Pre-dose iTOSS||0|-0.6|0.058
72602125|NCT00435461|144733810|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.15||0.16|TWO_SIDED|95.0|-0.5|0.0|||ANCOVA|||Pre-dose iTOSS||0|-0.5|0.16
72602126|NCT00435461|144733811|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.8|STANDARD_ERROR_OF_MEAN|1.59|<|0.001|TWO_SIDED|95.0|5.7|11.9|||ANCOVA|||Morning assessment||11.9|5.7|<0.001
72602127|NCT00435461|144733811|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.4|STANDARD_ERROR_OF_MEAN|1.59|<|0.001|TWO_SIDED|95.0|5.3|11.5|||ANCOVA|||Morning assessment||11.5|5.3|<0.001
72602128|NCT00435461|144733811|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|1.59||0.779|TWO_SIDED|95.0|-3.6|2.7|||ANCOVA|||Morning assessment||2.7|-3.6|0.779
72602129|NCT00435461|144733811|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.3|STANDARD_ERROR_OF_MEAN|1.65|<|0.001|TWO_SIDED|95.0|3.1|9.6|||ANCOVA|||Evening assessment||9.6|3.1|<0.001
72602130|NCT00435461|144733811|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.0|STANDARD_ERROR_OF_MEAN|1.65|<|0.001|TWO_SIDED|95.0|3.8|10.3|||ANCOVA|||Evening assessment||10.3|3.8|<0.001
72602131|NCT00435461|144733811|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.7|STANDARD_ERROR_OF_MEAN|1.65||0.662|TWO_SIDED|95.0|-2.5|4.0|||ANCOVA|||Evening assessment||4|-2.5|0.662
72602132|NCT00435461|144733812|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|0.11|<|0.001|TWO_SIDED|95.0|-0.7|-0.3|||ANCOVA|||||-0.3|-0.7|<0.001
72602133|NCT00435461|144733812|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.11||0.203|TWO_SIDED|95.0|-0.4|0.1|||ANCOVA|||||0.1|-0.4|0.203
72602134|NCT00435461|144733812|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.11|<|0.001|TWO_SIDED|95.0|-0.8|-0.4|||ANCOVA|||||-0.4|-0.8|<0.001
72602135|NCT01850394|144733820|SUPERIORITY_OR_OTHER||Mean Difference (Net)|180.0|STANDARD_DEVIATION|300.0|<|0.05|TWO_SIDED|95.0|||||ANOVA|||||||<0.05
72602136|NCT01850394|144733820|SUPERIORITY_OR_OTHER||Mean Difference (Net)|150.0|STANDARD_DEVIATION|200.0|<|0.05|TWO_SIDED|95.0|||||ANOVA|||||||<0.05
72602137|NCT01850394|144733821|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|140.0|STANDARD_DEVIATION|15.0|<|0.05|TWO_SIDED|95.0|||||ANOVA|||||||<0.05
72602138|NCT01850394|144733821|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|15.0|STANDARD_DEVIATION|4.0|<|0.05|TWO_SIDED|95.0|||||ANOVA|||||||<0.05
72602139|NCT01850394|144733822|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.25|STANDARD_ERROR_OF_MEAN|0.1|<|0.05|TWO_SIDED|95.0|||||Fisher Exact|||||||<0.05
72602140|NCT01850394|144733823|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.1|STANDARD_ERROR_OF_MEAN|0.02|<|0.05|TWO_SIDED|95.0|||||Fisher Exact|||||||<0.05
72602141|NCT01850394|144733824|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.66|STANDARD_DEVIATION|1.0||0.05|TWO_SIDED|95.0|||||ANOVA|||||||0.05
72602142|NCT00547157|144733829|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.09|||||TWO_SIDED|95.0|-0.26|0.07|||||difference is PRT - CRT|||0.07|-0.26|
72602143|NCT00547157|144733830|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.613||||0.0601|TWO_SIDED|95.0|0.98|2.656|||Regression, Cox||Hazard ratio is presented as panitumumab plus radiotherapy:chemoradiotherapy.|||2.656|0.980|0.0601
72602144|NCT00547157|144733831|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.731||||0.0259|TWO_SIDED|95.0|1.068|2.806|||Regression, Cox||Hazard ratio is presented as panitumumab plus radiotherapy:chemoradiotherapy.|||2.806|1.068|0.0259
72602145|NCT00547157|144733832|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.593||||0.1039|TWO_SIDED|95.0|0.909|2.793|||Regression, Cox||Hazard ratio is presented as panitumumab plus radiotherapy:chemoradiotherapy|||2.793|0.909|0.1039
72602146|NCT00547157|144733833|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.791||||0.5744|TWO_SIDED|95.0|0.342|1.785|||Regression, Logistic||The odd ratio is defined as the odds of having an objective response in the panitumumab plus radiotherapy arm relative to the odds in the chemoradiotherapy arm.|||1.785|0.342|0.5744
72602147|NCT00547157|144733833|SUPERIORITY_OR_OTHER||Difference in objective response rate|-0.044|||||TWO_SIDED|95.0|-0.187|0.112|||||Difference is objective response rate in the panitumumab plus radiotherapy arm minus the rate in the chemoradiotherapy arm.|||0.112|-0.187|
72602148|NCT00547157|144733834|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.278||||0.807|TWO_SIDED|95.0|0.438|4.043|||Regression, Logistic||The odd ratio is defined as the odds of having an objective response in the panitumumab plus radiotherapy arm relative to the odds in the chemoradiotherapy arm.|||4.043|0.438|0.8070
72602149|NCT00547157|144733834|SUPERIORITY_OR_OTHER||Difference in complete response rate|0.029|||||TWO_SIDED|95.0|-0.103|0.141|||||Difference is objective response rate in the panitumumab plus radiotherapy arm minus the rate in the chemoradiotherapy arm.|||0.141|-0.103|
72602150|NCT05415462|144733835|NON_INFERIORITY|The endpoint was tested for noninferiority of mRNA-1010 vs Fluarix for Influenza A H1N1 strain at a 2-sided 0.025 level.|Geometric Mean Ratio (GMR)|1.01|||||TWO_SIDED|97.5|0.952|1.071||||||GMR (mRNA-1010 vs Fluarix) for Influenza A H1N1 Antibody||1.071|0.952|
72602151|NCT05415462|144733835|NON_INFERIORITY|The endpoint was tested for noninferiority of mRNA-1010 vs Fluarix for Influenza A H3N2 strain at a 2-sided 0.025 level.|GMR|1.657|||||TWO_SIDED|97.5|1.562|1.757||||||GMR (mRNA-1010 vs Fluarix) for Influenza A H3N2 Antibody||1.757|1.562|
72602152|NCT05415462|144733835|NON_INFERIORITY|The endpoint was tested for noninferiority of mRNA-1010 vs Fluarix for Influenza B Victoria-lineage strain at a 2-sided 0.025 level.|GMR|0.665|||||TWO_SIDED|97.5|0.63|0.702||||||GMR (mRNA-1010 vs Fluarix) for Influenza B/ Victoria Lineage||0.702|0.630|
72602153|NCT05415462|144733835|NON_INFERIORITY|The endpoint was tested for noninferiority of mRNA-1010 vs Fluarix for Influenza B Yamagata-lineage strain at a 2-sided 0.025 level.|GMR|0.661|||||TWO_SIDED|97.5|0.63|0.693||||||GMR (mRNA-1010 vs Fluarix) for Influenza B/ Yamagata Lineage||0.693|0.630|
72602154|NCT05415462|144733836|NON_INFERIORITY|The endpoint was tested for noninferiority of mRNA-1010 vs Fluarix for Influenza A H1N1 strain at a 2-sided 0.025 level.|Percentage Difference|5.75|||||TWO_SIDED|97.5|3.12|8.38||||||Percentage Difference (mRNA-1010 vs Fluarix) for Influenza A H1N1 Antibody||8.38|3.12|
72602155|NCT05415462|144733836|NON_INFERIORITY|The endpoint was tested for noninferiority of mRNA-1010 vs Fluarix for Influenza A H3N2 strain at a 2-sided 0.025 level.|Percentage Difference|16.91|||||TWO_SIDED|97.5|14.27|19.54||||||Percentage Difference (mRNA-1010 vs Fluarix) for Influenza A H3N2 Antibody||19.54|14.27|
72602156|NCT05415462|144733836|NON_INFERIORITY|The endpoint was tested for noninferiority of mRNA-1010 vs Fluarix for Influenza B Victoria-lineage strain at a 2-sided 0.025 level.|Percentage Difference|-17.34|||||TWO_SIDED|97.5|-20.22|-14.43||||||Percentage Difference (mRNA-1010 vs Fluarix) for Influenza B/Victoria Lineage||-14.43|-20.22|
72602157|NCT05415462|144733836|NON_INFERIORITY|The endpoint was tested for noninferiority of mRNA-1010 vs Fluarix for Influenza B Yamagata-lineage strain at a 2-sided 0.025 level.|Percentage Difference|-15.68|||||TWO_SIDED|97.5|-18.57|-12.76||||||Percentage Difference (mRNA-1010 vs Fluarix) for Influenza B/Yamagata Lineage||-12.76|-18.57|
72602158|NCT02259699|144733847|SUPERIORITY|||||||0.582|||||||t-test, 2 sided|||Difference between arms at T1||||0.582
72602159|NCT02259699|144733847|SUPERIORITY|||||||0.053|||||||t-test, 2 sided|||Difference between arms at T3||||0.053
72602160|NCT02259699|144733847|SUPERIORITY|||||||0.288|||||||t-test, 2 sided|||Difference between arms at T4||||0.288
72602161|NCT02259699|144733848|SUPERIORITY|||||||0.087|||||||t-test, 2 sided|||Difference between arms at T3||||0.087
72602162|NCT02259699|144733848|SUPERIORITY|||||||0.91|||||||t-test, 2 sided|||Difference between arms at T4||||0.910
72602163|NCT02259699|144733849|SUPERIORITY|||||||0.807|||||||t-test, 2 sided|||||||0.807
72602164|NCT02259699|144733850|SUPERIORITY|||||||0.071|||||||t-test, 2 sided|||Difference between arms at T3||||0.071
72602165|NCT02259699|144733850|SUPERIORITY|||||||0.332|||||||t-test, 2 sided|||Difference between arms at T4||||0.332
72602166|NCT02259699|144733851|SUPERIORITY|||||||0.177|||||||t-test, 2 sided|||Difference between arms at T3||||0.177
72602167|NCT02259699|144733851|SUPERIORITY|||||||0.745|||||||t-test, 2 sided|||Difference between arms at T4||||0.745
72602168|NCT02432209|144733883|SUPERIORITY||Risk Ratio (RR)|0.81||||0.404|TWO_SIDED|95.0|0.48|1.34|||Chi-squared|||||1.34|0.48|0.404
72602169|NCT01087203|144733890|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) mean difference|-1.22|STANDARD_ERROR_OF_MEAN|0.53||0.025|TWO_SIDED|95.0|-2.28|-0.16|||ANCOVA|||Analysis of Covariance (ANCOVA) model with treatment as main effect, baseline value as covariate, and study site as a random effect was used.||-0.16|-2.28|0.025
72602170|NCT01087203|144733891|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.31||0.332|TWO_SIDED|95.0|-0.92|0.32|||ANCOVA|||Week 1: ANCOVA model with treatment as main effect, baseline value as covariate, and study site as a random effect was used.||0.32|-0.92|0.332
72602171|NCT01087203|144733891|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.38||0.297|TWO_SIDED|95.0|-1.15|0.36|||ANCOVA|||Week 2: ANCOVA model with treatment as main effect, baseline value as covariate, and study site as a random effect was used.||0.36|-1.15|0.297
72602172|NCT01087203|144733891|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.95|STANDARD_ERROR_OF_MEAN|0.42||0.029|TWO_SIDED|95.0|-1.81|-0.1|||ANCOVA|||Week 4: ANCOVA model with treatment as main effect, baseline value as covariate, and study site as a random effect was used.||-0.10|-1.81|0.029
72602173|NCT01087203|144733891|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.24|STANDARD_ERROR_OF_MEAN|0.46||0.01|TWO_SIDED|95.0|-2.17|-0.3|||ANCOVA|||Week 6: ANCOVA model with treatment as main effect, baseline value as covariate, and study site as a random effect was used.||-0.30|-2.17|0.010
72602174|NCT01087203|144733891|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.32|STANDARD_ERROR_OF_MEAN|0.49||0.009|TWO_SIDED|95.0|-2.3|-0.34|||ANCOVA|||Week 8: ANCOVA model with treatment as main effect, baseline value as covariate, and study site as a random effect was used.||-0.34|-2.30|0.009
72602175|NCT01087203|144733891|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.31|STANDARD_ERROR_OF_MEAN|0.52||0.015|TWO_SIDED|95.0|-2.36|-0.27|||ANCOVA|||Week 12: ANCOVA model with treatment as main effect, baseline value as covariate, and study site as a random effect was used.||-0.27|-2.36|0.015
72602176|NCT03828214|144733917|SUPERIORITY||Mean Difference (Final Values)|2.4|STANDARD_DEVIATION|9.2||0.973|TWO_SIDED|||||a priori threshold for statistical significance was 0.05.|ANOVA|||C2, C3, C4 were compared to C1 the comparison condition.||||0.973
72602177|NCT00502853|144733937|SUPERIORITY_OR_OTHER|||||||0.1776|||||||Student's t-test|||Change from Baseline to Week 4||||0.1776
72602178|NCT00502853|144733937|SUPERIORITY_OR_OTHER|||||||0.1215|||||||Student's t-test|||Change from Baseline to Week 24||||0.1215
72602179|NCT00502853|144733937|SUPERIORITY_OR_OTHER||Slope|-0.1606|STANDARD_ERROR_OF_MEAN|0.1231||0.2246|||||||Random coefficient model|||Trend over time||||0.2246
72602180|NCT00502853|144733938|SUPERIORITY_OR_OTHER|||||||0.8989|||||||Student's t-test|||Change from Baseline to Week 4||||0.8989
72602181|NCT00502853|144733938|SUPERIORITY_OR_OTHER|||||||0.8834|||||||Student's t-test|||Change from Baseline to Week 24||||0.8834
72602182|NCT00502853|144733938|SUPERIORITY_OR_OTHER||Slope|0.1357|STANDARD_ERROR_OF_MEAN|0.9051||0.8841|||||||Random coefficient model|||Trend over time||||0.8841
72602183|NCT00502853|144733939|SUPERIORITY_OR_OTHER|||||||0.5911|||||||Student's t-test|||Change from Baseline to Week 4||||0.5911
72602184|NCT00502853|144733939|SUPERIORITY_OR_OTHER|||||||0.1475|||||||Student's t-test|||Change from Baseline to Week 24||||0.1475
72602185|NCT00502853|144733939|SUPERIORITY_OR_OTHER||Slope|0.1786|STANDARD_ERROR_OF_MEAN|0.1123||0.1463|||||||Random coefficient model|||Trend over time||||0.1463
72602186|NCT00502853|144733940|SUPERIORITY_OR_OTHER|||||||0.1101|||||||Student's t-test|||Change from Baseline at Week 4||||0.1101
72602187|NCT00502853|144733940|SUPERIORITY_OR_OTHER|||||||0.0003|||||||Student's t-test|||Change from Baseline at Week 12||||0.0003
72602188|NCT00502853|144733940|SUPERIORITY_OR_OTHER|||||||0.0018|||||||Student's t-test|||Change from Baseline at Week 24||||0.0018
72602189|NCT00502853|144733940|SUPERIORITY_OR_OTHER||Slope|-2.0857|STANDARD_ERROR_OF_MEAN|0.4965||0.0023|||||||Random coefficient model|||Trend over time||||0.0023
72602190|NCT00502853|144733941|SUPERIORITY_OR_OTHER|||||||0.3358|||||||Student's t-test|||Change from Baseline at Week 4||||0.3358
72602191|NCT00502853|144733941|SUPERIORITY_OR_OTHER|||||||0.9158|||||||Student's t-test|||Change from Baseline at Week 24||||0.9158
72602192|NCT00502853|144733941|SUPERIORITY_OR_OTHER||Slope|0.003418|STANDARD_ERROR_OF_MEAN|0.02345||0.8877|||||||Random coefficient model|||Trend over time||||0.8877
72602193|NCT00502853|144733942|SUPERIORITY_OR_OTHER|||||||0.7624|||||||Student's t-test|||Change from Baseline at Week 4||||0.7624
72602194|NCT00502853|144733942|SUPERIORITY_OR_OTHER|||||||0.0212|||||||Student's t-test|||Change from Baseline at Week 24||||0.0212
72602195|NCT00502853|144733942|SUPERIORITY_OR_OTHER||Slope|-4.2681|STANDARD_ERROR_OF_MEAN|2.0529||0.0712|||||||Random coefficient model|||Trend over time||||0.0712
72602196|NCT00502853|144733943|SUPERIORITY_OR_OTHER|||||||0.024|||||||Student's t-test|||Change from Baseline at Week 4||||0.0240
72602197|NCT00502853|144733943|SUPERIORITY_OR_OTHER|||||||0.0045|||||||Student's t-test|||Change from Baseline at Week 12||||0.0045
72602198|NCT00502853|144733943|SUPERIORITY_OR_OTHER|||||||0.0018|||||||Student's t-test|||Change from Baseline at Week 24||||0.0018
72602199|NCT00502853|144733943|SUPERIORITY_OR_OTHER||Slope|-0.1964|STANDARD_ERROR_OF_MEAN|0.04524||0.0019|||||||Random Coefficient Model|||Trend over time||||0.0019
72602200|NCT00502853|144733944|SUPERIORITY_OR_OTHER||Slope|-6.6294|STANDARD_ERROR_OF_MEAN|1.8623||0.0074|||||||Random Coefficient Model|||Trend over time||||0.0074
72602201|NCT00502853|144733944|SUPERIORITY_OR_OTHER|||||||0.1273|||||||Student's t-test|||Change from Baseline at Week 4||||0.1273
72602202|NCT00502853|144733944|SUPERIORITY_OR_OTHER|||||||0.0132|||||||Student's t-test|||Change from Baseline at Week 12||||0.0132
72602203|NCT00502853|144733944|SUPERIORITY_OR_OTHER|||||||0.1542|||||||Student's t-test|||Change from Baseline at Week 24||||0.1542
72552512|NCT02262377|144635834|SUPERIORITY|The ITT analysis was done for 21 week BPI Interference.|Risk Ratio (RR)|0.98||||0.36|TWO_SIDED|95.0|0.88|1.08||Statistical significance was set at p\< 0.05.|Regression, Poisson|||||1.08|0.88|0.36
72552513|NCT02262377|144635834|SUPERIORITY|The ITT analysis was done for 21 week BPI Severity.|Risk Ratio (RR)|1.0||||0.996|TWO_SIDED|95.0|0.86|1.16||Statistical significance was set at p\< 0.05.|Regression, Poisson|||||1.16|0.86|0.996
72552514|NCT02262377|144635835|SUPERIORITY||Risk Ratio (RR)|1.17||||0.054|TWO_SIDED|95.0|0.99|1.37|||Regression, Poisson|||||1.37|0.99|0.054
72552515|NCT02262377|144635836|SUPERIORITY||Risk Ratio (RR)|1.0||||0.98|TWO_SIDED|95.0|0.89|1.13|||Regression, Poisson|||||1.13|0.89|0.98
72552516|NCT02262377|144635837|SUPERIORITY||Odds Ratio (OR)|0.42|||||TWO_SIDED|95.0|0.18|0.98|||Odds Ratio|||||0.98|0.18|
72552517|NCT02262377|144635838|SUPERIORITY||Odds Ratio (OR)|1.01|||||TWO_SIDED|95.0|0.9|1.14|||Odds Ratio|||||1.14|0.90|
72552518|NCT00723528|144635843|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Fisher's exact test (using Holm's method)|Fisher Exact|||||||<0.0001
72552519|NCT00723528|144635844|SUPERIORITY_OR_OTHER||||||<|0.0001||||||2-sample t-test (using Holm's method)|t-test, 2 sided|||||||<0.0001
72552520|NCT00723528|144635854|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Fisher's exact test (using Holm's method)|Fisher Exact|||||||<0.0001
72552521|NCT01993030|144635856|SUPERIORITY_OR_OTHER|||||||0.49|TWO_SIDED|||||Values of p \< 0.05 were considered to be significantly different.|Fisher Exact|||"Two-sided Fisher's exact test was performed to assess statistically significant differences of the data of the Number of Participants with Growth of Granulation Tissue between the group treated with the HQ® Matrix Medical Wound Dressing and that treated with the Sidaiyi® wound dressing.~This Statistical Analysis applies to the Participants with healthy granulation tissue and the Participants with unhealthy granulation tissue category."||||0.49
72552522|NCT01993030|144635857|SUPERIORITY_OR_OTHER|||||||0.36|TWO_SIDED|||||Values of p \< 0.05 were considered to be significantly different.|Fisher Exact|||"Two-sided Fisher's exact test was performed to assess statistically significant differences of the data of the Number of Participants with Inflammatory Reaction between the group treated with the HQ® Matrix Medical Wound Dressing and that treated with the Sidaiyi® wound dressing.~This Statistical Analysis applies to the Participants with Inflammatory Reaction and the Participants without Inflammatory Reaction category."||||0.36
72552523|NCT01993030|144635858|SUPERIORITY_OR_OTHER|||||||0.11|TWO_SIDED|||||Values of p \< 0.05 were considered to be significantly different.|t-test, 2 sided|||Two-sided t-test was performed to assess statistically significant differences of the data of the VAS score between the group treated with the HQ® Matrix Medical Wound Dressing and that treated with the Sidaiyi® wound dressing.||||0.11
72552524|NCT01993030|144635859|SUPERIORITY_OR_OTHER|||||||0.11|TWO_SIDED|||||Values of p \< 0.05 were considered to be significantly different.|Fisher Exact|||"Two-sided Fisher's exact test was performed to assess statistically significant differences of the data of the Number of Participants with Exudation between the group treated with the HQ® Matrix Medical Wound Dressing and that treated with the Sidaiyi® wound dressing.~This Statistical Analysis applies to No exudation and Little exudation category."||||0.11
72552525|NCT01993030|144635860|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED|||||Values of p \< 0.05 were considered to be significantly different.|t-test, 2 sided|||Two-sided t-test was performed to assess statistically significant differences of the data of the Time to Wound Healing between the group treated with the HQ® Matrix Medical Wound Dressing and that treated with the Sidaiyi® wound dressing.||||0.02
72552526|NCT01710657|144635861|SUPERIORITY_OR_OTHER||% Reduction over Placebo|39.6|||<|0.001|TWO_SIDED|95.0|30.5|47.6||Significant at the 0.05 level. This testing procedure is considered a closed testing procedure and no adjustment of the significance level was necessary.|ANCOVA|||"To avoid inflation of Type I error, hypothesis testing followed predefined hierarchical procedure starting LCM 400 mg/day treatment group versus the placebo group.~If the test was not statistically significant, the procedure stopped and no Groups were declared different from placebo. If the test was statistically significant, the treatment group was considered different from placebo and the procedure continued with the LCM 200 mg/day treatment group."||47.6|30.5|<0.001
72552527|NCT01710657|144635861|SUPERIORITY_OR_OTHER||% Reduction over Placebo|29.4|||<|0.001|TWO_SIDED|95.0|18.7|38.7||Significant at the 0.05 level. This testing procedure is considered a closed testing procedure and no adjustment of the significance level was necessary.|ANCOVA|||"To avoid inflation of Type I error, hypothesis testing followed predefined hierarchical procedure starting LCM 400 mg/day treatment group versus the placebo group.~If the test was not statistically significant, the procedure stopped and no Groups were declared different from placebo. If the test was statistically significant, the treatment group was considered different from placebo and the procedure continued with the LCM 200 mg/day treatment group."||38.7|18.7|< 0.001
72552528|NCT01591785|144635881|SUPERIORITY_OR_OTHER_LEGACY|||||||0.035|TWO_SIDED||||||Chi-squared|||||||0.035
72552529|NCT01591785|144635882|SUPERIORITY_OR_OTHER_LEGACY|||||||0.28|TWO_SIDED||||||Chi-squared|||||||0.28
72552530|NCT01591785|144635883|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0495|TWO_SIDED||||||Chi-squared|||||||0.0495
72602204|NCT00502853|144733945|SUPERIORITY_OR_OTHER|||||||0.1396|||||||Student's t-test|||Change from Baseline at Week 4||||0.1396
72602205|NCT00502853|144733945|SUPERIORITY_OR_OTHER|||||||0.005|||||||Student's t-test|||Change from Baseline at Week 12||||0.0050
72552531|NCT01591785|144635884|SUPERIORITY_OR_OTHER_LEGACY|||||||0.27|TWO_SIDED||||||Chi-squared|||||||0.27
72552532|NCT01049334|144635887|SUPERIORITY_OR_OTHER||least-square means difference|-151.5||||0.0201|TWO_SIDED|95.0|-278.9|-24.0||The a priori threshold for statistical significance is 0.05. No adjustments for statistical multiplicity were required.|ANOVA|Treatment as a fixed effect and baseline STPIS as a covariate.||||-24.0|-278.9|0.0201
72552533|NCT01049334|144635888|SUPERIORITY_OR_OTHER||least-square means difference|-19.6|||<|0.0001|TWO_SIDED|95.0|-29.2|-9.9||The a priori threshold for statistical significance is 0.05. Closed-sequential approach to control type I error: analyses through secondary outcomes #2-13 in the order listed will proceed until a p-value \>0.05 occurs.|ANOVA|Treatment as a fixed effect and baseline of the variable predicted as a covariate||||-9.9|-29.2|<.0001
72602206|NCT00502853|144733945|SUPERIORITY_OR_OTHER|||||||0.005|||||||Student's t-test|||Change from Baseline at Week 24||||0.0050
72602207|NCT00502853|144733945|SUPERIORITY_OR_OTHER||Slope|-0.2902|STANDARD_ERROR_OF_MEAN|0.07966||0.0054|||||||Random coefficient model|||Trend over time||||0.0054
72602208|NCT00502853|144733946|SUPERIORITY_OR_OTHER|||||||0.0254|||||||Student's t-test|||Change from Baseline at Week 4||||0.0254
72602209|NCT00502853|144733946|SUPERIORITY_OR_OTHER|||||||0.0384|||||||Student's t-test|||Change from Baseline at Week 12||||0.0384
72602210|NCT00502853|144733946|SUPERIORITY_OR_OTHER|||||||0.0271|||||||Student's t-test|||Change from Baseline at Week 24||||0.0271
72602211|NCT00502853|144733946|SUPERIORITY_OR_OTHER||Slope|-4.7586|STANDARD_ERROR_OF_MEAN|1.5278||0.0124|||||||Random coefficient model|||Trend over time||||0.0124
72552534|NCT01049334|144635889|SUPERIORITY_OR_OTHER||least-square means difference|-22.3|||<|0.0001|TWO_SIDED|95.0|-31.7|-12.9||The a priori threshold for statistical significance is 0.05. Closed-sequential approach to control type I error: analyses through secondary outcomes #2-13 in the order listed will proceed until a p-value \>0.05 occurs.|ANOVA|Treatment as a fixed effect and baseline of the variable predicted as a covariate||||-12.9|-31.7|<0.0001
72602212|NCT00502853|144733947|SUPERIORITY_OR_OTHER|||||||0.7376|||||||Student's t-test|||Change from Baseline at Week 4||||0.7376
72602213|NCT00502853|144733947|SUPERIORITY_OR_OTHER|||||||0.1631|||||||Student's t-test|||Change from Baseline at Week 12||||0.1631
72602214|NCT00502853|144733947|SUPERIORITY_OR_OTHER|||||||0.8816|||||||Student's t-test|||Change from Baseline at Week 24||||0.8816
72552535|NCT01049334|144635890|SUPERIORITY_OR_OTHER||least-square means difference|-181.7||||0.0071|TWO_SIDED|95.0|-313.7|-50.0||The a priori threshold for statistical significance is 0.05. Closed-sequential approach to control type I error: analyses through secondary outcomes #2-13 in the order listed will proceed until a p-value \>0.05 occurs.|ANOVA|Treatment as a fixed effect and baseline of the variable predicted as a covariate||||-50.0|-313.7|0.0071
72552536|NCT01049334|144635891|SUPERIORITY_OR_OTHER||least-square means difference|-20.8|||<|0.0001|TWO_SIDED|95.0|-30.2|-11.2||The a priori threshold for statistical significance is 0.05. Closed-sequential approach to control type I error: analyses through secondary outcomes #2-13 in the order listed will proceed until a p-value \>0.05 occurs.|ANOVA|Treatment as a fixed effect and baseline of the variable predicted as a covariate||||-11.2|-30.2|<0.0001
72552537|NCT01049334|144635892|SUPERIORITY_OR_OTHER||least-square means difference|-137.6||||0.0393|TWO_SIDED|95.0|-268.5|-6.8||The a priori threshold for statistical significance is 0.05. Closed-sequential approach to control type I error: analyses through secondary outcomes #2-13 in the order listed will proceed until a p-value \>0.05 occurs.|ANOVA|Treatment as a fixed effect and baseline of the variable predicted as a covariate||||-6.8|-268.5|0.0393
72552538|NCT01049334|144635893|SUPERIORITY_OR_OTHER|||||||0.0459||||||The a priori threshold for statistical significance is 0.05. Closed-sequential approach to control type I error: analyses through secondary outcomes #2-13 in the order listed will proceed until a p-value \>0.05 occurs.|Wilcoxon (Mann-Whitney)|||||||0.0459
72552539|NCT01049334|144635894|SUPERIORITY_OR_OTHER|||||||0.8383||||||The a priori threshold for statistical significance is 0.05. Closed-sequential approach to control type I error: analyses through secondary outcomes #2-13 in the order listed will proceed until a p-value \>0.05 occurs.|Wilcoxon (Mann-Whitney)|||||||0.8383
72602215|NCT00502853|144733947|SUPERIORITY_OR_OTHER||Slope|-0.2927|STANDARD_ERROR_OF_MEAN|1.9408||0.8835|||||||Random coefficient model|||Trend over time||||0.8835
72602216|NCT00502853|144733948|SUPERIORITY_OR_OTHER|||||||0.1312|||||||Student's t-test|||Change from Baseline at Week 4||||0.1312
72602217|NCT00502853|144733948|SUPERIORITY_OR_OTHER|||||||0.0662|||||||Student's t-test|||Change from Baseline at Week 12||||0.0662
72602218|NCT00502853|144733948|SUPERIORITY_OR_OTHER|||||||0.4133|||||||Student's t-test|||Change from Baseline at Week 24||||0.4133
72602219|NCT00502853|144733948|SUPERIORITY_OR_OTHER||Slope|8.8196|STANDARD_ERROR_OF_MEAN|16.4534||0.6049|||||||Random coefficient model|||Trend over time||||0.6049
72602220|NCT00502853|144733949|SUPERIORITY_OR_OTHER|||||||0.1725|||||||Student's t-test|||Change from Baseline at Week 4||||0.1725
72602221|NCT00502853|144733949|SUPERIORITY_OR_OTHER|||||||0.0832|||||||Student's t-test|||Change from Baseline at Week 12||||0.0832
72602222|NCT00502853|144733949|SUPERIORITY_OR_OTHER|||||||0.1685|||||||Student's t-test|||Change from Baseline at Week 24||||0.1685
72602223|NCT00502853|144733949|SUPERIORITY_OR_OTHER||Slope|-55.4458|STANDARD_ERROR_OF_MEAN|33.5821||0.1331|||||||Random coefficient model|||Trend over time||||0.1331
72602224|NCT00502853|144733950|SUPERIORITY_OR_OTHER|||||||0.2938|||||||Student's t-test|||Change from Baseline at Week 4||||0.2938
72602225|NCT00502853|144733950|SUPERIORITY_OR_OTHER|||||||0.2216|||||||Student's t-test|||Change from Baseline at Week 12||||0.2216
72602226|NCT00502853|144733950|SUPERIORITY_OR_OTHER|||||||0.567|TWO_SIDED||||||Student's t-test|||Change from Baseline at Week 24||||0.5670
72602227|NCT00502853|144733951|SUPERIORITY_OR_OTHER|||||||0.0934|||||||Student's t-test|||Change from Baseline at Week 4||||0.0934
72602228|NCT00502853|144733951|SUPERIORITY_OR_OTHER|||||||0.4047|||||||Student's t-test|||Change from Baseline at Week 12||||0.4047
72602229|NCT00502853|144733951|SUPERIORITY_OR_OTHER|||||||0.2101|||||||Student's t-test|||Change from Baseline at Week 24||||0.2101
72602230|NCT00502853|144733951|SUPERIORITY_OR_OTHER||Slope|0.3997|STANDARD_ERROR_OF_MEAN|0.2506||0.1451|||||||Random coefficient model|||Trend over time||||0.1451
72602231|NCT00502853|144733952|SUPERIORITY_OR_OTHER|||||||0.4963|||||||Student's t-test|||Change from Baseline at Week 4||||0.4963
72602232|NCT00502853|144733952|SUPERIORITY_OR_OTHER|||||||0.2198|||||||Student's t-test|||Change from Baseline at Week 12||||0.2198
72602233|NCT00502853|144733952|SUPERIORITY_OR_OTHER|||||||0.6773|||||||Student's t-test|||Change from Baseline at Week 24||||0.6773
72602234|NCT00502853|144733952|SUPERIORITY_OR_OTHER||Slope|0.3688|STANDARD_ERROR_OF_MEAN|0.5987||0.5531|||||||Random coefficient model|||Trend over time||||0.5531
72602235|NCT00502853|144733953|SUPERIORITY_OR_OTHER|||||||0.5002|||||||Student's t-test|||Change from Baseline at Week 24||||0.5002
72602236|NCT00502853|144733954|SUPERIORITY_OR_OTHER|||||||1|||||||Student's t-test|||Change from Baseline at Week 24||||1.0000
72602237|NCT00502853|144733955|SUPERIORITY_OR_OTHER|||||||0.7002|||||||Student's t-test|||Change from Baseline at Week 24||||0.7002
72602238|NCT00502853|144733956|SUPERIORITY_OR_OTHER|||||||0.3132|||||||Student's t-test|||Change from Baseline at Week 24||||0.3132
72602239|NCT00502853|144733957|SUPERIORITY_OR_OTHER|||||||0.8597|||||||Student's t-test|||Change from Baseline at Week 24||||0.8597
72602240|NCT00502853|144733958|SUPERIORITY_OR_OTHER|||||||0.3617|||||||Student's t-test|||Change from Baseline at Week 24||||0.3617
72602241|NCT00461097|144734006|SUPERIORITY_OR_OTHER||Risk Difference (RD)|27.5||||0.025|TWO_SIDED|95.0|4.3|43.9||No adjustments were made to the p-value.|Barnard's statistic|The a priori threshold for statistical significance is 0.05.||Number of participants who successfully consumed 10,000 mg of egg white solid was compared using Barnard's statistic with the null hypothesis that there was no difference between treatment groups.||43.9|4.3|0.025
72602242|NCT04378569|144734018|SUPERIORITY||Odds Ratio (OR)|1.11||||0.5788|TWO_SIDED|95.0|0.49|2.53|||Cochran-Mantel-Haenszel|Stratified by pooled site group and baseline IGA score with multiple imputation used to handle missing data|Stratified by pooled site group and baseline IGA score with multiple imputation used to handle missing data|||2.53|0.49|0.5788
72602243|NCT04378569|144734018|SUPERIORITY||Odds Ratio (OR)|0.84||||0.6488|TWO_SIDED|95.0|0.33|2.17|||Cochran-Mantel-Haenszel|Stratified by pooled site group and baseline IGA score with multiple imputation used to handle missing data|Stratified by pooled site group and baseline IGA score with multiple imputation used to handle missing data|||2.17|0.33|0.6488
72602244|NCT04378569|144734018|SUPERIORITY||Odds Ratio (OR)|0.85||||0.5653|TWO_SIDED|95.0|0.32|2.25|||Cochran-Mantel-Haenszel|Stratified by pooled site group and baseline IGA score with multiple imputation used to handle missing data|Stratified by pooled site group and baseline IGA score with multiple imputation used to handle missing data|||2.25|0.32|0.5653
72602245|NCT04378569|144734019|SUPERIORITY||Odds Ratio (OR)|0.84||||0.5033|TWO_SIDED|95.0|0.25|2.78|||Cochran-Mantel-Haenszel|Stratified by pooled site group and baseline IGA score with multiple imputation to handle missing data|Stratified by pooled site group and baseline IGA score with multiple imputation to handle missing data|||2.78|0.25|0.5033
72602246|NCT04378569|144734019|SUPERIORITY||Odds Ratio (OR)|0.83||||0.4975|TWO_SIDED|95.0|0.25|2.79|||Cochran-Mantel-Haenszel|Stratified by pooled site group and baseline IGA score with multiple imputation to handle missing data|Stratified by pooled site group and baseline IGA score with multiple imputation to handle missing data|||2.79|0.25|0.4975
72602247|NCT04378569|144734019|SUPERIORITY||Odds Ratio (OR)|0.33|||||TWO_SIDED|95.0|0.04|2.55||P value was not evaluable|Cochran-Mantel-Haenszel|Stratified by pooled site group and baseline IGA score with multiple imputation to handle missing data|Stratified by pooled site group and baseline IGA score with multiple imputation to handle missing data|||2.55|0.04|
72602248|NCT04378569|144734020|SUPERIORITY||Odds Ratio (OR)|0.75||||0.7237|TWO_SIDED|95.0|0.23|2.44|||Cochran-Mantel-Haenszel|Stratified by pooled site group and baseline IGA score, with multiple imputation of missing data|Stratified by pooled site group and baseline IGA score, with multiple imputation of missing data|||2.44|0.23|0.7237
72602249|NCT04378569|144734020|SUPERIORITY||Odds Ratio (OR)|0.59||||0.838|TWO_SIDED|95.0|0.17|2.1|||Cochran-Mantel-Haenszel|Stratified by pooled site group and baseline IGA score, with multiple imputation of missing data|Stratified by pooled site group and baseline IGA score, with multiple imputation of missing data|||2.10|0.17|0.8380
72602250|NCT04378569|144734020|SUPERIORITY||Odds Ratio (OR)|0.33|||||TWO_SIDED|95.0|0.04|2.55||p-value was unevaluable||Stratified by pooled site group and baseline IGA score, with multiple imputation of missing data|Stratified by pooled site group and baseline IGA score, with multiple imputation of missing data|||2.55|0.04|
72602251|NCT04378569|144734021|SUPERIORITY||Odds Ratio (OR)|0.97||||0.9604|TWO_SIDED|95.0|0.31|3.07|||Cochran-Mantel-Haenszel|Stratified by pooled site group and baseline IGA score, with multiple imputation of missing data|Stratified by pooled site group and baseline IGA score, with multiple imputation of missing data|Week 2||3.07|0.31|0.9604
72602252|NCT04378569|144734021|SUPERIORITY||Odds Ratio (OR)|1.02||||0.9752|TWO_SIDED|95.0|0.32|3.25|||Cochran-Mantel-Haenszel|Stratified by pooled site group and baseline IGA score, with multiple imputation of missing data|Stratified by pooled site group and baseline IGA score, with multiple imputation of missing data|Week 2||3.25|0.32|0.9752
72602253|NCT04378569|144734021|SUPERIORITY||Odds Ratio (OR)|0.57||||0.5077|TWO_SIDED|95.0|0.11|3.03|||Cochran-Mantel-Haenszel|Stratified by pooled site group and baseline IGA score, with multiple imputation of missing data|Stratified by pooled site group and baseline IGA score, with multiple imputation of missing data|Week 2||3.03|0.11|0.5077
72602254|NCT04378569|144734021|SUPERIORITY||Odds Ratio (OR)|0.74||||0.5916|TWO_SIDED|95.0|0.26|2.15|||Cochran-Mantel-Haenszel|Stratified by pooled site group and baseline IGA score, with multiple imputation of missing data|Stratified by pooled site group and baseline IGA score, with multiple imputation of missing data|Week 4||2.15|0.26|0.5916
72602255|NCT04378569|144734021|SUPERIORITY||Odds Ratio (OR)|0.65||||0.332|TWO_SIDED|95.0|0.27|1.57|||Cochran-Mantel-Haenszel|Stratified by pooled site group and baseline IGA score, with multiple imputation of missing data|Stratified by pooled site group and baseline IGA score, with multiple imputation of missing data|Week 4||1.57|0.27|0.3320
72602256|NCT04378569|144734021|SUPERIORITY||Odds Ratio (OR)|0.47||||0.1922|TWO_SIDED|95.0|0.14|1.57|||Cochran-Mantel-Haenszel|Stratified by pooled site group and baseline IGA score, with multiple imputation of missing data|Stratified by pooled site group and baseline IGA score, with multiple imputation of missing data|Week 4||1.57|0.14|0.1922
72602257|NCT04378569|144734021|SUPERIORITY||Odds Ratio (OR)|0.65||||0.4188|TWO_SIDED|95.0|0.23|1.81|||Cochran-Mantel-Haenszel|Stratified by pooled site group and baseline IGA score, with multiple imputation of missing data|Stratified by pooled site group and baseline IGA score, with multiple imputation of missing data|Week 8||1.81|0.23|0.4188
72602258|NCT04378569|144734021|SUPERIORITY||Odds Ratio (OR)|0.74||||0.552|TWO_SIDED|95.0|0.29|1.92|||Cochran-Mantel-Haenszel|Stratified by pooled site group and baseline IGA score, with multiple imputation of missing data|Stratified by pooled site group and baseline IGA score, with multiple imputation of missing data|Week 8||1.92|0.29|0.5520
72602259|NCT04378569|144734021|SUPERIORITY||Odds Ratio (OR)|0.69||||0.69|TWO_SIDED|95.0|0.21|2.2|||Cochran-Mantel-Haenszel|Stratified by pooled site group and baseline IGA score, with multiple imputation of missing data|Stratified by pooled site group and baseline IGA score, with multiple imputation of missing data|Week 8||2.20|0.21|0.69
72602260|NCT04378569|144734022|SUPERIORITY|Week 2|Mean Difference (Net)|-0.06||||0.6464|TWO_SIDED|95.0|-0.33|0.21|||ANCOVA|Treatment group, pooled site group, and baseline IGA were independent variables, with multiple imputation of missing data|Treatment group, pooled site group, and baseline IGA were independent variables, with multiple imputation of missing data|||0.21|-0.33|0.6464
72602261|NCT04378569|144734022|SUPERIORITY||Mean Difference (Final Values)|-0.02||||0.8881|TWO_SIDED|95.0|-0.29|0.25|||ANCOVA|Treatment group, pooled site group, and baseline IGA were independent variables, with multiple imputation of missing data|Treatment group, pooled site group, and baseline IGA were independent variables, with multiple imputation of missing data|Week 2||0.25|-0.29|0.8881
72602262|NCT04378569|144734022|SUPERIORITY||Mean Difference (Final Values)|0.13||||0.436|TWO_SIDED|95.0|-0.2|0.46|||ANCOVA|Treatment group, pooled site group, and baseline IGA were independent variables, with multiple imputation of missing data|Treatment group, pooled site group, and baseline IGA were independent variables, with multiple imputation of missing data|Week 2||0.46|-0.20|0.4360
72602263|NCT04378569|144734022|SUPERIORITY||Mean Difference (Final Values)|0.04||||0.8196|TWO_SIDED|95.0|-0.29|0.36|||ANCOVA|Treatment group, pooled site group, and baseline IGA were independent variables, with multiple imputation of missing data|Treatment group, pooled site group, and baseline IGA were independent variables, with multiple imputation of missing data|Week 4||0.36|-0.29|0.8196
72602264|NCT04378569|144734022|SUPERIORITY||Mean Difference (Final Values)|0.02||||0.9217|TWO_SIDED|95.0|-0.31|0.34|||ANCOVA|Treatment group, pooled site group, and baseline IGA were independent variables, with multiple imputation of missing data|Treatment group, pooled site group, and baseline IGA were independent variables, with multiple imputation of missing data|Week 4||0.34|-0.31|0.9217
72602265|NCT04378569|144734022|SUPERIORITY||Mean Difference (Final Values)|0.14||||0.4783|TWO_SIDED|95.0|-0.25|0.53|||ANCOVA|Treatment group, pooled site group, and baseline IGA were independent variables, with multiple imputation of missing data|Treatment group, pooled site group, and baseline IGA were independent variables, with multiple imputation of missing data|||0.53|-0.25|0.4783
72602266|NCT04378569|144734022|SUPERIORITY||Mean Difference (Final Values)|0.06||||0.7725|TWO_SIDED|95.0|-0.32|0.43|||ANCOVA|Treatment group, pooled site group, and baseline IGA were independent variables, with multiple imputation of missing data|Treatment group, pooled site group, and baseline IGA were independent variables, with multiple imputation of missing data|Week 8||0.43|-0.32|0.7725
72602267|NCT04378569|144734022|SUPERIORITY||Mean Difference (Final Values)|-0.05||||0.7861|TWO_SIDED|95.0|-0.43|0.33|||ANCOVA|Treatment group, pooled site group, and baseline IGA were independent variables, with multiple imputation of missing data|Treatment group, pooled site group, and baseline IGA were independent variables, with multiple imputation of missing data|Week 8||0.33|-0.43|0.7861
72602268|NCT04378569|144734022|SUPERIORITY||Mean Difference (Final Values)|0.22||||0.3521|TWO_SIDED|95.0|-0.24|0.68|||ANCOVA|Treatment group, pooled site group, and baseline IGA were independent variables, with multiple imputation of missing data|Treatment group, pooled site group, and baseline IGA were independent variables, with multiple imputation of missing data|Week 8||0.68|-0.24|0.3521
72602269|NCT04378569|144734022|SUPERIORITY||Mean Difference (Final Values)|-0.24||||0.2166|TWO_SIDED|95.0|-0.62|0.14|||ANCOVA|Treatment group, pooled site group, and baseline IGA were independent variables, with multiple imputation of missing data|Treatment group, pooled site group, and baseline IGA were independent variables, with multiple imputation of missing data|Week 12||0.14|-0.62|0.2166
72602270|NCT04378569|144734022|SUPERIORITY||Mean Difference (Final Values)|-0.13||||0.5262|TWO_SIDED|95.0|-0.52|0.27|||ANCOVA|Treatment group, pooled site group, and baseline IGA were independent variables, with multiple imputation of missing data|Treatment group, pooled site group, and baseline IGA were independent variables, with multiple imputation of missing data|Week 12||0.27|-0.52|0.5262
72602271|NCT04378569|144734022|SUPERIORITY||Mean Difference (Final Values)|0.07||||0.7575|TWO_SIDED|95.0|-0.39|0.54|||ANCOVA|Treatment group, pooled site group, and baseline IGA were independent variables, with multiple imputation of missing data|Treatment group, pooled site group, and baseline IGA were independent variables, with multiple imputation of missing data|Week 12||0.54|-0.39|0.7575
72602272|NCT04378569|144734024|SUPERIORITY||Odds Ratio (OR)|1.73||||0.2662|TWO_SIDED|95.0|0.64|4.7|||Cochran-Mantel-Haenszel|Stratified|Stratified|Week 2||4.70|0.64|0.2662
72602273|NCT04378569|144734024|SUPERIORITY||Odds Ratio (OR)|1.54||||0.3798|TWO_SIDED|95.0|0.59|4.0|||Cochran-Mantel-Haenszel|||Week 2||4.00|0.59|0.3798
72602274|NCT04378569|144734024|SUPERIORITY||Odds Ratio (OR)|3.18||||0.0611|TWO_SIDED|95.0|0.9|11.17|||Cochran-Mantel-Haenszel|||Week 2||11.17|0.90|0.0611
72602275|NCT04378569|144734024|SUPERIORITY||Odds Ratio (OR)|1.58||||0.3129|TWO_SIDED|95.0|0.64|3.93|||Cochran-Mantel-Haenszel|||Week 4||3.93|0.64|0.3129
72602276|NCT04378569|144734024|SUPERIORITY||Odds Ratio (OR)|0.97||||0.9586|TWO_SIDED|95.0|0.35|2.74|||Cochran-Mantel-Haenszel|||Week 4||2.74|0.35|0.9586
72602277|NCT04378569|144734024|SUPERIORITY||Odds Ratio (OR)|3.65||||0.0643|TWO_SIDED|95.0|0.87|15.29|||Cochran-Mantel-Haenszel|||Week 4||15.29|0.87|0.0643
72602278|NCT04378569|144734024|SUPERIORITY||Odds Ratio (OR)|2.41||||0.0932|TWO_SIDED|95.0|0.84|6.88|||Cochran-Mantel-Haenszel|||Week 8||6.88|0.84|0.0932
72602279|NCT04378569|144734024|SUPERIORITY||Odds Ratio (OR)|1.42||||0.573|TWO_SIDED|95.0|0.44|4.59|||Cochran-Mantel-Haenszel|||Week 8||4.59|0.44|0.5730
72602280|NCT04378569|144734024|SUPERIORITY||Odds Ratio (OR)|4.96||||0.0389|TWO_SIDED|95.0|0.96|25.66|||Cochran-Mantel-Haenszel|||Week 8||25.66|0.96|0.0389
72602281|NCT04378569|144734024|SUPERIORITY||Odds Ratio (OR)|1.82||||0.2813|TWO_SIDED|95.0|0.6|5.53|||Cochran-Mantel-Haenszel|||Week 12||5.53|0.60|0.2813
72602282|NCT04378569|144734024|SUPERIORITY||Odds Ratio (OR)|0.72||||0.6841|TWO_SIDED|95.0|0.17|3.03|||Cochran-Mantel-Haenszel|||Week 12||3.03|0.17|0.6841
72602283|NCT04378569|144734024|SUPERIORITY||Odds Ratio (OR)|2.13||||0.3113|TWO_SIDED|95.0|0.49|9.21|||Cochran-Mantel-Haenszel|||Week 12||9.21|0.49|0.3113
72602284|NCT04378569|144734027|SUPERIORITY||Odds Ratio (OR)|2.21||||0.2674|TWO_SIDED|95.0|0.46|10.67|||Cochran-Mantel-Haenszel|Stratified by pooled site group and baseline IGA grade|Stratified by pooled site group and baseline IGA grade|Week 2||10.67|0.46|0.2674
72602285|NCT04378569|144734027|SUPERIORITY||Odds Ratio (OR)|2.78||||0.285|TWO_SIDED|95.0|0.44|17.54|||Cochran-Mantel-Haenszel|Stratified by pooled site group and baseline IGA grade|Stratified by pooled site group and baseline IGA grade|Week 2||17.54|0.44|0.2850
72602286|NCT04378569|144734027|SUPERIORITY||Odds Ratio (OR)|2.63||||0.3086|TWO_SIDED|95.0|0.42|16.52|||Cochran-Mantel-Haenszel|Stratified by pooled site group and baseline IGA grade|Stratified by pooled site group and baseline IGA grade|Week 2||16.52|0.42|0.3086
72602287|NCT04378569|144734027|SUPERIORITY||Odds Ratio (OR)|4.33||||0.1655|TWO_SIDED|95.0|0.46|40.83|||Cochran-Mantel-Haenszel|Stratified by pooled site group and baseline IGA grade|Stratified by pooled site group and baseline IGA grade|Week 4||40.83|0.46|0.1655
72602288|NCT04378569|144734027|SUPERIORITY||Odds Ratio (OR)|1.41||||0.7154|TWO_SIDED|95.0|0.26|7.67|||Cochran-Mantel-Haenszel|Stratified by pooled site group and baseline IGA grade|Stratified by pooled site group and baseline IGA grade|Week 4||7.67|0.26|0.7154
72602289|NCT04378569|144734027|SUPERIORITY||Odds Ratio (OR)|2.0||||0.5371|TWO_SIDED|95.0|0.27|14.64|||Cochran-Mantel-Haenszel|Stratified by pooled site group and baseline IGA grade|Stratified by pooled site group and baseline IGA grade|Week 4||14.64|0.27|0.5371
72602290|NCT04378569|144734027|SUPERIORITY||Odds Ratio (OR)|5.0||||0.217|TWO_SIDED|95.0|0.43|57.83|||Cochran-Mantel-Haenszel|Stratified by pooled site group and baseline IGA grade|Stratified by pooled site group and baseline IGA grade|Week 8||57.83|0.43|0.2170
72602291|NCT04378569|144734027|SUPERIORITY||Odds Ratio (OR)|2.74||||0.3408|TWO_SIDED|95.0|0.41|18.22|||Cochran-Mantel-Haenszel|Stratified by pooled site group and baseline IGA grade|Stratified by pooled site group and baseline IGA grade|Week 8||18.22|0.41|0.3408
72602292|NCT04378569|144734027|SUPERIORITY||Odds Ratio (OR)|2.4||||0.327|TWO_SIDED|95.0|0.41|14.2|||Cochran-Mantel-Haenszel|Stratified by pooled site group and baseline IGA grade|Stratified by pooled site group and baseline IGA grade|Week 8||14.20|0.41|0.3270
72602293|NCT04378569|144734027|SUPERIORITY|||||||0.0719|||||||Cochran-Mantel-Haenszel|Stratified by pooled site group and baseline IGA grade||Week 12||||0.0719
72602294|NCT04378569|144734027|SUPERIORITY||Odds Ratio (OR)|0.78||||0.8527|TWO_SIDED|95.0|0.07|8.43|||Cochran-Mantel-Haenszel|Stratified by pooled site group and baseline IGA grade||Week 12||8.43|0.07|0.8527
72602295|NCT04378569|144734027|SUPERIORITY||Odds Ratio (OR)|2.2||||0.3545|TWO_SIDED|95.0|0.37|13.11|||Cochran-Mantel-Haenszel|Stratified by pooled site group and baseline IGA grade||Week 12||13.11|0.37|0.3545
72602296|NCT04378569|144734028|SUPERIORITY||Mean Difference (Final Values)|-4.4||||0.0725|TWO_SIDED|95.0|-9.2|0.4|||ANCOVA|Treatment group, pooled site group, and baseline IGA were independent variables|Treatment group, pooled site group, and baseline IGA were independent variables|Week 2||0.4|-9.2|0.0725
72602297|NCT04378569|144734028|SUPERIORITY||Mean Difference (Final Values)|-5.8||||0.0183|TWO_SIDED|95.0|-10.7|-1.0|||ANCOVA|Treatment group, pooled site group, and baseline IGA were independent variables|Treatment group, pooled site group, and baseline IGA were independent variables|Week 2||-1.0|-10.7|0.0183
72602298|NCT04378569|144734028|SUPERIORITY||Mean Difference (Final Values)|-1.7||||0.5701|TWO_SIDED|95.0|-7.7|4.3|||ANCOVA|Treatment group, pooled site group, and baseline IGA were independent variables||Week 2||4.3|-7.7|0.5701
72602299|NCT04378569|144734028|SUPERIORITY||Mean Difference (Final Values)|-4.0||||0.2116|TWO_SIDED|95.0|-10.4|2.3|||ANCOVA|Treatment group, pooled site group, and baseline IGA were independent variables|Treatment group, pooled site group, and baseline IGA were independent variables|Week 4||2.3|-10.4|0.2116
72602300|NCT04378569|144734028|SUPERIORITY||Mean Difference (Final Values)|-5.1||||0.1235|TWO_SIDED|95.0|-11.5|1.4|||ANCOVA|Treatment group, pooled site group, and baseline IGA were independent variables|Treatment group, pooled site group, and baseline IGA were independent variables|Week 4||1.4|-11.5|0.1235
72602301|NCT04378569|144734028|SUPERIORITY||Mean Difference (Final Values)|-1.9||||0.6334|TWO_SIDED|95.0|-9.7|5.9|||ANCOVA|Treatment group, pooled site group, and baseline IGA were independent variables|Treatment group, pooled site group, and baseline IGA were independent variables|Week 4||5.9|-9.7|0.6334
72602302|NCT04378569|144734028|SUPERIORITY||Mean Difference (Final Values)|-4.6||||0.1788|TWO_SIDED|95.0|-11.4|2.1|||ANCOVA|Treatment group, pooled site group, and baseline IGA were independent variables|Treatment group, pooled site group, and baseline IGA were independent variables|Week 8||2.1|-11.4|0.1788
72602303|NCT04378569|144734028|SUPERIORITY||Mean Difference (Final Values)|-7.6||||0.0292|TWO_SIDED|95.0|-14.4|-0.8|||ANCOVA|Treatment group, pooled site group, and baseline IGA were independent variables|Treatment group, pooled site group, and baseline IGA were independent variables|Week 8||-0.8|-14.4|0.0292
72602304|NCT04378569|144734028|SUPERIORITY||Mean Difference (Final Values)|-8.8||||0.0371|TWO_SIDED|95.0|-17.1|-0.5|||ANCOVA|Treatment group, pooled site group, and baseline IGA were independent variables|Treatment group, pooled site group, and baseline IGA were independent variables|Week 8||-0.5|-17.1|0.0371
72602305|NCT04378569|144734028|SUPERIORITY||Mean Difference (Final Values)|-3.9||||0.2971|TWO_SIDED|95.0|-11.3|3.5|||ANCOVA|Treatment group, pooled site group, and baseline IGA were independent variables|Treatment group, pooled site group, and baseline IGA were independent variables|Week 12||3.5|-11.3|0.2971
72602306|NCT04378569|144734028|SUPERIORITY||Mean Difference (Final Values)|-9.5||||0.015|TWO_SIDED|95.0|-17.2|-1.9|||ANCOVA|Treatment group, pooled site group, and baseline IGA were independent variables|Treatment group, pooled site group, and baseline IGA were independent variables|Week 12||-1.9|-17.2|0.0150
72602307|NCT04378569|144734028|SUPERIORITY||Mean Difference (Final Values)|-7.0||||0.1245|TWO_SIDED|95.0|-15.8|1.9|||ANCOVA|Treatment group, pooled site group, and baseline IGA were independent variables|Treatment group, pooled site group, and baseline IGA were independent variables|Week 12||1.9|-15.8|0.1245
72602308|NCT04378569|144734028|SUPERIORITY||Mean Difference (Final Values)|-5.3||||0.1591|TWO_SIDED|95.0|-12.7|2.1|||ANCOVA|Treatment group, pooled site group, and baseline IGA were independent variables|Treatment group, pooled site group, and baseline IGA were independent variables|Week 13||2.1|-12.7|0.1591
72602309|NCT04378569|144734028|SUPERIORITY||Mean Difference (Final Values)|-7.3||||0.06|TWO_SIDED|95.0|-14.8|0.3|||ANCOVA|Treatment group, pooled site group, and baseline IGA were independent variables|Treatment group, pooled site group, and baseline IGA were independent variables|Week 13||0.3|-14.8|0.0600
72602310|NCT04378569|144734028|SUPERIORITY||Mean Difference (Final Values)|-3.3||||0.464|TWO_SIDED|95.0|-12.0|5.5|||ANCOVA|Treatment group, pooled site group, and baseline IGA were independent variables|Treatment group, pooled site group, and baseline IGA were independent variables|Week 13||5.5|-12.0|0.4640
72602311|NCT04378569|144734029|SUPERIORITY||Mean Difference (Final Values)|-0.066||||0.3184|TWO_SIDED|95.0|-0.196|0.064|||ANCOVA|Treatment group, pooled site group, baseline IGA grade, and baseline % BSA were independent variables|Treatment group, pooled site group, and baseline IGA were independent variables|Week 2||0.064|-0.196|0.3184
72602312|NCT04378569|144734029|SUPERIORITY||Mean Difference (Final Values)|-0.013||||0.8514|TWO_SIDED|95.0|-0.149|0.123|||ANCOVA|Treatment group, pooled site group, baseline IGA grade, and baseline % BSA were independent variables|Treatment group, pooled site group, baseline IGA grade, and baseline % BSA were independent variables|Week 2||0.123|-0.149|0.8514
72602313|NCT04378569|144734029|SUPERIORITY||Mean Difference (Final Values)|0.091||||0.2603|TWO_SIDED|95.0|-0.068|0.249|||ANCOVA|Treatment group, pooled site group, baseline IGA grade, and baseline % BSA were independent variables|Treatment group, pooled site group, baseline IGA grade, and baseline % BSA were independent variables|Week 2||0.249|-0.068|0.2603
72602314|NCT04378569|144734029|SUPERIORITY||Mean Difference (Final Values)|-0.171||||0.0273|TWO_SIDED|95.0|-0.323|-0.019|||ANCOVA|Treatment group, pooled site group, baseline IGA grade, and baseline % BSA were independent variables|Treatment group, pooled site group, baseline IGA grade, and baseline % BSA were independent variables|Week 4||-0.019|-0.323|0.0273
72602315|NCT04378569|144734029|SUPERIORITY||Mean Difference (Final Values)|-0.18||||0.0266|TWO_SIDED|95.0|-0.339|-0.021|||ANCOVA|Treatment group, pooled site group, baseline IGA grade, and baseline % BSA were independent variables|Treatment group, pooled site group, baseline IGA grade, and baseline % BSA were independent variables|Week 4||-0.021|-0.339|0.0266
72602316|NCT04378569|144734029|SUPERIORITY||Mean Difference (Final Values)|-0.012||||0.9023|TWO_SIDED|95.0|-0.196|0.173|||ANCOVA|Treatment group, pooled site group, baseline IGA grade, and baseline % BSA were independent variables|Treatment group, pooled site group, baseline IGA grade, and baseline % BSA were independent variables|Week 4||0.173|-0.196|0.9023
72602317|NCT04378569|144734029|SUPERIORITY||Mean Difference (Final Values)|-0.096||||0.3298|TWO_SIDED|95.0|-0.291|0.098|||ANCOVA|Treatment group, pooled site group, baseline IGA grade, and baseline % BSA were independent variables|Treatment group, pooled site group, baseline IGA grade, and baseline % BSA were independent variables|Week 8||0.098|-0.291|0.3298
72602318|NCT04378569|144734029|SUPERIORITY||Mean Difference (Final Values)|-0.05||||0.6205|TWO_SIDED|95.0|-0.251|0.15|||ANCOVA|Treatment group, pooled site group, baseline IGA grade, and baseline % BSA were independent variables|Treatment group, pooled site group, baseline IGA grade, and baseline % BSA were independent variables|Week 8||0.150|-0.251|0.6205
72602319|NCT04378569|144734029|SUPERIORITY||Mean Difference (Final Values)|-0.018||||0.8817|TWO_SIDED|95.0|-0.253|0.217|||ANCOVA|Treatment group, pooled site group, baseline IGA grade, and baseline % BSA were independent variables|Treatment group, pooled site group, baseline IGA grade, and baseline % BSA were independent variables|Week 8||0.217|-0.253|0.8817
72602320|NCT04378569|144734029|SUPERIORITY||Mean Difference (Final Values)|-0.122||||0.1837|TWO_SIDED|95.0|-0.302|0.058|||ANCOVA|Treatment group, pooled site group, baseline IGA grade, and baseline % BSA were independent variables|Treatment group, pooled site group, baseline IGA grade, and baseline % BSA were independent variables|Week 12||0.058|-0.302|0.1837
72602321|NCT04378569|144734029|SUPERIORITY||Mean Difference (Final Values)|-0.102||||0.2896|TWO_SIDED|95.0|-0.293|0.088|||ANCOVA|Treatment group, pooled site group, baseline IGA grade, and baseline % BSA were independent variables|Treatment group, pooled site group, baseline IGA grade, and baseline % BSA were independent variables|||0.088|-0.293|0.2896
72602322|NCT04378569|144734029|SUPERIORITY||Mean Difference (Final Values)|0.031||||0.919|TWO_SIDED|95.0|-0.205|0.227|||ANCOVA|Treatment group, pooled site group, baseline IGA grade, and baseline % BSA were independent variables|Treatment group, pooled site group, baseline IGA grade, and baseline % BSA were independent variables|Week 12||0.227|-0.205|0.9190
72602323|NCT03159299|144734046|SUPERIORITY||Mean Difference (Final Values)|0.11|||<|0.15|TWO_SIDED||||||Mixed Models Analysis|||||||<0.15
72602324|NCT02501161|144734070|OTHER||||||<|0.0001|||||||Stratified log-rank test|||Test for no treatment difference was based on using a stratified log-rank test where treatment, baseline HbA1c group and pre-trial OAD treatment group were included as strata in the model.||||<.0001
72602325|NCT02501161|144734071|OTHER||||||<|0.0001|||||||Stratified log-rank test|||Test for no treatment difference was based on using a stratified log-rank test where treatment, baseline HbA1c group and pre-trial OAD treatment group were included as strata in the model.||||<.0001
72602326|NCT01000974|144734158|NON_INFERIORITY|To demonstrate the non-inferiority of Test Hib to Control Hib, each co-administered with DTPa-HBV-IPV, 13Pn and HRV vaccines, following 3 primary vaccine doses in terms of anti-PRP antibody concentration ≥ 1.0 μg/mL.|difference in percentage|-8.59|||||TWO_SIDED|95.0|-12.28|-4.07|||Non-inferiority analysis|||Non-inferiority Anti-PRP concentration ≥ 1.0 μg/mL||-4.07|-12.28|
72602327|NCT01000974|144734158|NON_INFERIORITY|To demonstrate the non-inferiority of Test Hib to Control Hib, each co-administered with DTPa-HBVIPV, 13Pn and HRV vaccines, following 3 primary vaccine doses in terms of anti-PRP antibody concentrations ≥ 0.15 μg/mL.|Difference in percentage|-0.11|||||TWO_SIDED|95.0|-1.98|2.82|||Non-inferiority analysis|||Non-inferiority Anti-PRP concentration≥ 0.15 μg/mL||2.82|-1.98|
72602328|NCT01000974|144734159|NON_INFERIORITY|To demonstrate the non-inferiority of DTPa-HBV-IPV co-administered with Test Hib, 13Pn and HRV to DTPa-HBV-IPV co-administered with Control Hib, 13Pn and HRV, following 3 primary vaccine doses in terms of immune response to diphtheria (Anti-D).|Difference in percentage|0.0|||||TWO_SIDED|95.0|-1.26|1.81|||Non-inferiority analysis|||Non-inferiority Anti-D antibody concentrations||1.81|-1.26|
72602329|NCT01000974|144734159|NON_INFERIORITY|To demonstrate the non-inferiority of DTPa-HBV-IPV co-administered with Test Hib, 13Pn and HRV to DTPa-HBV-IPV co-administered with Control Hib, 13Pn and HRV, following 3 primary vaccine doses in terms of immune response to tetanus (Anti-T).|Difference in percentage|0.0|||||TWO_SIDED|95.0|-1.26|1.8|||Non-inferiority analysis|||Non-inferiority Anti-T antibody concentrations||1.8|-1.26|
72602330|NCT01000974|144734161|NON_INFERIORITY|To demonstrate the non-inferiority of DTPa-HBV-IPV co-administered with Test Hib, 13Pn and HRV to DTPa-HBV-IPV co-administered with Control Hib, 13Pn and HRV, following 3 primary vaccine doses in terms of immune response to pertussis toxoid \[PT\].|GMC ratio|1.017|||||TWO_SIDED|97.5|0.918|1.127|||Non-inferiority analysis|||Non-inferiority GMC ratio anti-PT||1.127|0.918|
72602331|NCT01000974|144734161|NON_INFERIORITY|To demonstrate the non-inferiority of DTPa-HBV-IPV co-administered with Test Hib, 13Pn and HRV to DTPa-HBV-IPV co-administered with Control Hib, 13Pn and HRV, following 3 primary vaccine doses in terms of immune response to filamentous hemagglutinin \[FHA\].|GMC ratio|1.088|||||TWO_SIDED|97.5|0.983|1.204|||Non-inferiority analysis|||Non-inferiority GMC ratio anti-FHA||1.204|0.983|
72602332|NCT01000974|144734161|NON_INFERIORITY|To demonstrate the non-inferiority of DTPa-HBV-IPV co-administered with Test Hib, 13Pn and HRV to DTPa-HBV-IPV co-administered with Control Hib, 13Pn and HRV, following 3 primary vaccine doses in terms of immune response to pertactin \[PRN\]|GMC ratio|1.193|||||TWO_SIDED|97.5|1.03|1.382|||Non-inferiority analysis|||Non-inferiority GMC ratio anti-PRN||1.382|1.03|
72602333|NCT01000974|144734162|NON_INFERIORITY|To demonstrate the non-inferiority of a 3-dose primary vaccination course of 13Pn co-administered with Test Hib, HRV and DTPa-HBV-IPV compared to that of 13Pn co-administered with Control Hib, HRV and DTPa-HBV-IPV in terms of Streptococcus pneumoniae (S.pneumoniae) GMCs|GMC ratio|1.006|||||TWO_SIDED|97.5|0.873|1.159|||Non-inferiority analysis|||Non-inferiority Anti-Pneumoniae 1 concentrations||1.159|0.873|
72602334|NCT01000974|144734162|NON_INFERIORITY|To demonstrate the non-inferiority of a 3-dose primary vaccination course of 13Pn co-administered with Test Hib, HRV and DTPa-HBV-IPV compared to that of 13Pn co-administered with Control Hib, HRV and DTPa-HBV-IPV in terms of Streptococcus pneumoniae (S.pneumoniae) GMCs.|GMC ratio|1.048|||||TWO_SIDED|97.5|0.921|1.192|||Non-inferiority analysis|||Non-inferiority Anti-Pneumoniae 3 concentrations||1.192|0.921|
72602335|NCT01000974|144734162|NON_INFERIORITY|To demonstrate the non-inferiority of a 3-dose primary vaccination course of 13Pn co-administered with Test Hib, HRV and DTPa-HBV-IPV compared to that of 13Pn co-administered with Control Hib, HRV and DTPa-HBV-IPV in terms of Streptococcus pneumoniae (S.pneumoniae) GMCs.|GMC ratio|1.001|||||TWO_SIDED|97.5|0.886|1.13|||Non-inferiority analysis|||Non-inferiority Anti-Pneumoniae 4 concentrations||1.13|0.886|
72602336|NCT01000974|144734162|NON_INFERIORITY|To demonstrate the non-inferiority of a 3-dose primary vaccination course of 13Pn co-administered with Test Hib, HRV and DTPa-HBV-IPV compared to that of 13Pn co-administered with Control Hib, HRV and DTPa-HBV-IPV in terms of Streptococcus pneumoniae (S.pneumoniae) GMCs.|GMC ratio|1.02|||||TWO_SIDED|97.5|0.874|1.19|||Non-inferiority analysis|||Non-inferiority Anti-Pneumoniae 5 concentrations||1.19|0.874|
72602337|NCT01000974|144734162|NON_INFERIORITY|To demonstrate the non-inferiority of a 3-dose primary vaccination course of 13Pn co-administered with Test Hib, HRV and DTPa-HBV-IPV compared to that of 13Pn co-administered with Control Hib, HRV and DTPa-HBV-IPV in terms of Streptococcus pneumoniae (S.pneumoniae) GMCs|GMC ratio|1.031|||||TWO_SIDED|97.5|0.894|1.188|||Non-inferiority analysis|||Non-inferiority Anti-Pneumoniae 6A concentrations||1.188|0.894|
72602338|NCT01000974|144734162|NON_INFERIORITY|To demonstrate the non-inferiority of a 3-dose primary vaccination course of 13Pn co-administered with Test Hib, HRV and DTPa-HBV-IPV compared to that of 13Pn co-administered with Control Hib, HRV and DTPa-HBV-IPV in terms of Streptococcus pneumoniae (S.pneumoniae) GMCs|GMC ratio|1.072|||||TWO_SIDED|97.5|0.871|1.32|||Non-inferiority analysis|||Non-inferiority Anti-Pneumoniae 6B concentrations||1.32|0.871|
72602339|NCT01000974|144734162|NON_INFERIORITY|To demonstrate the non-inferiority of a 3-dose primary vaccination course of 13Pn co-administered with Test Hib, HRV and DTPa-HBV-IPV compared to that of 13Pn co-administered with Control Hib, HRV and DTPa-HBV-IPV in terms of Streptococcus pneumoniae (S.pneumoniae) GMCs.|GMC ratio|1.098|||||TWO_SIDED|97.5|0.964|1.251|||Non-inferiority analysis|||Non-inferiority Anti-Pneumoniae 7F concentrations||1.251|0.964|
72602340|NCT01000974|144734162|NON_INFERIORITY|To demonstrate the non-inferiority of a 3-dose primary vaccination course of 13Pn co-administered with Test Hib, HRV and DTPa-HBV-IPV compared to that of 13Pn co-administered with Control Hib, HRV and DTPa-HBV-IPV in terms of Streptococcus pneumoniae (S.pneumoniae) GMCs.|GMC ratio|1.035|||||TWO_SIDED|97.5|0.89|1.204|||Non-inferiority analysis|||Non-inferiority Anti-Pneumoniae 9V concentrations||1.204|0.89|
72602341|NCT01000974|144734162|NON_INFERIORITY|To demonstrate the non-inferiority of a 3-dose primary vaccination course of 13Pn co-administered with Test Hib, HRV and DTPa-HBV-IPV compared to that of 13Pn co-administered with Control Hib, HRV and DTPa-HBV-IPV in terms of Streptococcus pneumoniae (S.pneumoniae) GMCs.|GMC ratio|1.096|||||TWO_SIDED|97.5|0.929|1.294|||Non-inferiority analysis|||Non-inferiority Anti-Pneumoniae 14 concentrations||1.294|0.929|
72602342|NCT01000974|144734162|NON_INFERIORITY|To demonstrate the non-inferiority of a 3-dose primary vaccination course of 13Pn co-administered with Test Hib, HRV and DTPa-HBV-IPV compared to that of 13Pn co-administered with Control Hib, HRV and DTPa-HBV-IPV in terms of Streptococcus pneumoniae (S.pneumoniae) GMCs.|GMC ratio|1.042|||||TWO_SIDED|97.5|0.9|1.207|||Non-inferiority analysis|||Non-inferiority Anti-Pneumoniae 18C concentrations||1.207|0.9|
72602343|NCT01000974|144734162|NON_INFERIORITY|To demonstrate the non-inferiority of a 3-dose primary vaccination course of 13Pn co-administered with Test Hib, HRV and DTPa-HBV-IPV compared to that of 13Pn co-administered with Control Hib, HRV and DTPa-HBV-IPV in terms of Streptococcus pneumoniae (S.pneumoniae) GMCs.|GMC ratio|1.001|||||TWO_SIDED|97.5|0.859|1.167|||Non-inferiority analysis|||Non-inferiority Anti-Pneumoniae 19A concentrations||1.167|0.859|
72602344|NCT01000974|144734162|NON_INFERIORITY|To demonstrate the non-inferiority of a 3-dose primary vaccination course of 13Pn co-administered with Test Hib, HRV and DTPa-HBV-IPV compared to that of 13Pn co-administered with Control Hib, HRV and DTPa-HBV-IPV in terms of Streptococcus pneumoniae (S.pneumoniae) GMCs.|GMC ratio|0.969|||||TWO_SIDED|97.5|0.855|1.098|||Non-inferiority analysis|||Non-inferiority Anti-Pneumoniae 19F concentrations||1.098|0.855|
72602345|NCT01000974|144734162|NON_INFERIORITY|To demonstrate the non-inferiority of a 3-dose primary vaccination course of 13Pn co-administered with Test Hib, HRV and DTPa-HBV-IPV compared to that of 13Pn co-administered with Control Hib, HRV and DTPa-HBV-IPV in terms of Streptococcus pneumoniae (S.pneumoniae) GMCs.|GMC ratio|1.031|||||TWO_SIDED|97.5|0.862|1.232|||Non-inferiority analysis|||Non-inferiority Anti-Pneumoniae 23F concentrations||1.232|0.862|
72602346|NCT01000974|144734163|OTHER|To rule out 10% decrease in seroresponse to FHA in subjects receiving DTPa-HBV-IPV coadministered with Test Hib,13Pn \& HRV vaccines compared to subjects receiving DTPa-HBV-IPV co-administered with Control Hib, 13Pn \&HRV vaccines,following 3 primary vaccine doses where seroresponse wasdefined as percentage of subjects showing aconcentration above a threshold that led to 95% seroresponse in control|||||<|0.0001|||||||t-test, 1 sided|P-value is computed by integrating on the p-values of one-sided test with alpha=0.025 \& the posterior probability of the cut-off in the control group||Difference in seroresponse Anti-FHA||||<0.0001
72602347|NCT01000974|144734163|OTHER|To rule out 10% decrease in seroresponse to PT in subjects receiving DTPa-HBV-IPV coadministered with Test Hib,13Pn \& HRV vaccines compared to subjects receiving DTPa-HBV-IPV co-administered with Control Hib, 13Pn \&HRV vaccines,following 3 primary vaccine doses where seroresponse wasdefined as percentage of subjects showing aconcentration above a threshold that led to 95% seroresponse in control|||||<|0.0001||||||P-value is computed by integrating on the p-values of one-sided test with alpha=0.025 and the posterior probability of the cut-off in the control group|t-test, 1 sided|||Difference in seroresponse Anti-PT||||<0.0001
72602348|NCT01000974|144734163|OTHER|To rule out 10% decrease in seroresponse to PRN in subjects receiving DTPa-HBV-IPV coadministered with Test Hib,13Pn \& HRV vaccines compared to subjects receiving DTPa-HBV-IPV co-administered with Control Hib, 13Pn \&HRV vaccines,following 3 primary vaccine doses where seroresponse wasdefined as percentage of subjects showing aconcentration above a threshold that led to 95% seroresponse in control|||||<|0.0001||||||P-value is computed by integrating on the p-values of one-sided test with alpha=0.025 and the posterior probability of the cut-off in the control group|t-test, 1 sided|||Difference in seroresponse Anti-PRN||||<0.0001
72602349|NCT01000974|144734164|NON_INFERIORITY|To demonstrate the non-inferiority of DTPa-HBV-IPV co-administered with Test Hib, 13Pn and HRV to DTPa-HBV-IPV co-administered with Control Hib, 13Pn and HRV, following 3 primary vaccine doses in terms of immune response to poliovirus 1.|Difference in percentage|-0.67|||||TWO_SIDED|97.5|-2.24|0.87|||Non-inferiority analysis|||Non-inferiority Anti-Polio 1 concentrations||0.87|-2.24|
72602350|NCT01000974|144734164|NON_INFERIORITY|To demonstrate the non-inferiority of DTPa-HBV-IPV co-administered with Test Hib, 13Pn and HRV to DTPa-HBV-IPV co-administered with Control Hib, 13Pn and HRV, following 3 primary vaccine doses in terms of immune response to poliovirus 2.|Difference in percentage|0.45|||||TWO_SIDED|97.5|-1.45|2.91|||Non-inferiority analysis|||Non-inferiority Anti-Polio 2 concentration||2.91|-1.45|
72602351|NCT01000974|144734164|NON_INFERIORITY|To demonstrate the non-inferiority of DTPa-HBV-IPV co-administered with Test Hib, 13Pn and HRV to DTPa-HBV-IPV co-administered with Control Hib, 13Pn and HRV, following 3 primary vaccine doses in terms of immune response to poliovirus 3.|Difference in percentage|-0.66|||||TWO_SIDED|97.5|-2.2|0.88|||Non-inferiority analysis|||Non-inferiority Anti-Polio 3 concentration||0.88|-2.2|
72602352|NCT02485483|144734204|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.67|||<|0.001|TWO_SIDED|95.0|0.59|0.74||"Convergent Validity Criterion Correlation coefficient (ρ) \> \|0.50\|"|t-test, 2 sided||Convergent correlation between PHQ-9 and MADRS|Number of participants analyzed (N) = 221||0.74|0.59|<0.001
72602353|NCT02485483|144734204|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.69|||<|0.001|TWO_SIDED|95.0|0.62|0.76||"Convergent Validity Criterion ρ \> \|0.50\|"|t-test, 2 sided||Convergent correlation between PHQ-9 and BDI-II|Number of participants analyzed (N) = 222||0.76|0.62|<0.001
72602354|NCT02485483|144734205|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.58||||0.057|TWO_SIDED|95.0|0.48|0.66||"Convergent Validity Criterion ρ \> \|0.50\|"|t-test, 2 sided||Convergent correlation between PHQ-9 and MADRS|Number of participants analyzed (N) = 203||0.66|0.48|0.057
72602355|NCT02485483|144734205|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.74|||<|0.001|TWO_SIDED|95.0|0.67|0.8||"Convergent Validity Criterion ρ \> \|0.50\|"|t-test, 2 sided||Convergent correlation between PHQ-9 and BDI-II|Number of participants analyzed (N) = 200||0.80|0.67|<0.001
72602356|NCT02485483|144734206|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.73|||<|0.001|TWO_SIDED|95.0|0.67|0.79||"Convergent Validity Criterion ρ \> \|0.50\|"|t-test, 2 sided||Convergent correlation between BDI-II and MADRS|Number of participants analyzed (N) = 258||0.79|0.67|<0.001
72602357|NCT02485483|144734207|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.71|||<|0.001|TWO_SIDED|95.0|0.64|0.77||"Convergent Validity Criterion ρ \> \|0.50\|"|t-test, 2 sided||Convergent correlation between BDI-II and MADRS|Number of participants analyzed (N) = 214||0.77|0.64|<0.001
72602358|NCT02485483|144734208|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|-0.59||||0.034|TWO_SIDED|95.0|-0.67|-0.49||"Convergent Validity Criterion ρ \> \|0.50\|"|t-test, 2 sided||Convergent correlation between WHO-5 and MADRS|Number of participants analyzed (N) = 222||-0.49|-0.67|0.034
72602359|NCT02485483|144734208|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|-0.61||||0.01|TWO_SIDED|95.0|-0.68|-0.52||"Convergent Validity Criterion ρ \> \|0.50\|"|t-test, 2 sided||Convergent correlation between WHO-5 and BDI-II|Number of participants analyzed (N) = 223||-0.52|-0.68|0.010
72602360|NCT02485483|144734208|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|-0.73|||<|0.001|TWO_SIDED|95.0|-0.78|-0.66||"Convergent Validity Criterion ρ \> \|0.50\|"|t-test, 2 sided||Convergent correlation between WHO-5 and PHQ-9|Number of participants analyzed (N) = 222||-0.66|-0.78|<0.001
72602361|NCT02485483|144734209|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|-0.54||||0.219|TWO_SIDED|95.0|-0.63|-0.43||"Convergent Validity Criterion ρ \> \|0.50\|"|t-test, 2 sided||Convergent correlation between WHO-5 and MADRS|Number of participants analyzed (N) = 202||-0.43|-0.63|0.219
72602362|NCT02485483|144734209|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|-0.68|||<|0.001|TWO_SIDED|95.0|-0.75|-0.6||"Convergent Validity Criterion ρ \> \|0.50\|"|t-test, 2 sided||Convergent correlation between WHO-5 and BDI-II|Number of participants analyzed (N) = 199||-0.60|-0.75|<0.001
72602363|NCT02485483|144734209|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|-0.77|||<|0.001|TWO_SIDED|95.0|-0.82|-0.7||"Convergent Validity Criterion ρ \> \|0.50\|"|t-test, 2 sided||Convergent correlation between WHO-5 and PHQ-9|Number of participants analyzed (N) = 205||-0.70|-0.82|<0.001
72602364|NCT01724177|144734218|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||"A one sample binomial one sided exact test for the ORR (CR, CRu, or PR) was performed to provide the p-value (significance level: 0.05). The hypotheses of interest:~H0: ORR ≤ 5% versus H1: ORR \> 5%"|Exact Test|||||||<0.0001
72602365|NCT00809094|144734249|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.21||||0.14|TWO_SIDED|95.0|-0.07|0.48|||t-test, 2 sided|||Null hypothesis: there will be no difference in the change in human neutrophil activity measured from baseline to end of the study (24 weeks)||0.48|-0.07|0.14
72602366|NCT00397189|144734256|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.6|STANDARD_DEVIATION|47.0|<|0.05|TWO_SIDED|95.0|-25.3|-6.0|||ANCOVA|||The analysis was a comparison of sleep latency as measured by the sleep diary at Visit 3 in the ITT 65-80 population, using a linear regression model with terms for treatment (Circadin® 2mg vs. Placebo) and baseline sleep latency.||-6|-25.3|<0.05
72602367|NCT01535443|144734258|OTHER|||||||0.374|||||||Traza Pillai|The test was performed with degrees of freedom: 2||||||.374
72602368|NCT02620683|144734270|OTHER||Median Difference (Final Values)|-15.0||||0.006|TWO_SIDED|95.0|-34.6|-5.86|||Wilcoxon (Mann-Whitney)||for a cross over design difference in blood level was calculate buffered lidocaine minus non-buffered lidocaine|The difference between injection type- 95% confidence intervals for the difference between injection types was calculated. For the outcome variable, an assessment of treatment difference by subject, calculated as 1% Buffered minus 2% Non-Buffered, was performed using Wilcoxon signed rank tests (SAS v 9.3). Statistical significance was set as P \< 0.05 for all outcomes.||-5.86|-34.6|0.006
72602369|NCT02620683|144734271|OTHER||Mean Difference (Final Values)|-0.66||||0.096|TWO_SIDED|95.0|-1.46|0.13|||t-test, 2 sided|||The difference between injection type- 95% confidence intervals for the difference between injection types was calculated. For the outcome variable, an assessment of treatment difference by subject, calculated as 1% Buffered minus 2% Non-Buffered, was performed using ProcTTEST (SAS v 9.3). Statistical significance was set as P \< 0.05 for all outcomes.||0.13|-1.46|0.096
72602370|NCT02620683|144734272|OTHER||Median Difference (Final Values)|-1.0||||0.23|TWO_SIDED|95.0|-4.0|1.0|||Wilcoxon (Mann-Whitney)|||The difference between injection type- 95% confidence intervals for the difference between injection types was calculated. For the outcome variable, an assessment of treatment difference by subject, calculated as 1% Buffered minus 2% Non-Buffered, was performed using Wilcoxon signed rank tests (SAS v 9.3). Statistical significance was set as P \< 0.05 for all outcomes.||1|-4|0.23
72602371|NCT01556932|144734306|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.8|STANDARD_DEVIATION|3.2541|||TWO_SIDED|||||||||||||
72602372|NCT01882803|144734307|OTHER||||||<=|0.0001||||||'\<=' represents '≤'|Exact Binomial Test|The p-value was calculated by 1-sided exact binomial test with the null hypothesis that ORR ≤30%.||ORR was tested against the null (≤30%) by 1-sided exact binomial test at 0.025 level.||||<=0.0001
72602373|NCT03066778|144734317|SUPERIORITY||Hazard Ratio (HR)|0.73||||0.00069|TWO_SIDED|95.0|0.6|0.88|||Log Rank|One-sided p-value based on log-rank test stratified by platinum chemotherapy, ECOG, and LDH|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by platinum chemotherapy, ECOG, and LDH|||0.88|0.60|0.00069
72602374|NCT03066778|144734318|SUPERIORITY||Hazard Ratio (HR)|0.8||||0.01643|TWO_SIDED|95.0|0.64|0.98|||Log Rank|One-sided p-value based on log-rank test stratified by platinum chemotherapy, ECOG, and LDH|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by platinum chemotherapy, ECOG, and LDH|||0.98|0.64|0.01643
72602375|NCT03066778|144734319|SUPERIORITY||Percent Difference|8.9||||0.0227|TWO_SIDED|95.0|0.2|17.4|||Miettinen & Nurminen|One-sided p-value for testing. H0: difference in percent = 0 versus H1: difference in percent \> 0.|Based on Miettinen \& Nurminen method stratified by platinum chemotherapy, ECOG, and LDH. Cisplatin, ECOG 0, LDH ≤ULN and Cisplatin, ECOG 0, LDH \>ULN were combined into one stratum because of small sample size|||17.4|0.2|0.02270
72602376|NCT03066778|144734324|OTHER||Difference in Least Square Means|4.43||||0.04|TWO_SIDED|95.0|0.21|8.66|||Log Rank|||||8.66|0.21|0.040
72602377|NCT03066778|144734327|OTHER||Hazard Ratio (HR)|0.8||||0.208|TWO_SIDED|95.0|0.56|1.14|||Log Rank|Two-sided p-value based on stratified log-rank test|Based on Cox regression model with treatment as a covariate stratified by platinum chemotherapy ECOG, and LDH. Cisplatin, ECOG 0, LDH ≤ULN and Cisplatin, ECOG 0, LDH \>ULN were combined into one stratum because of small sample size|||1.14|0.56|0.208
72602378|NCT03665077|144734330|OTHER|Linear mixed-effect model of log-transformed oxylipin level, with time (date) as a continuous variable, adjusted for batch and clustered on participant||||||0.684|||||||Mixed Models Analysis|Linear mixed-effect model of log-transformed oxylipin level: time (date) as a continuous variable, adjusted for batch and clustered on participant||||||0.684
72602379|NCT03665077|144734331|OTHER|Linear mixed-effect model of log-transformed oxylipin level, with time (date) as a continuous variable, adjusted for batch and clustered on participant||||||0.02|||||||Mixed Models Analysis|Linear mixed-effect model of log-transformed oxylipin level: time (date) as a continuous variable, adjusted for batch and clustered on participant||||||0.02
72602380|NCT03665077|144734332|OTHER|Linear mixed-effect model of log-transformed oxylipin level: time (date) as a continuous variable, adjusted for batch and clustered on participant||||||0.058|||||||Mixed Models Analysis|Linear mixed-effect model of log-transformed oxylipin level: time (date) as a continuous variable, adjusted for batch and clustered on participant||||||0.058
72602381|NCT00205660|144734337|SUPERIORITY|||||||0.03||||||The a priori threshold for statistical significance in this planned primary test was p\<0.05.|ANCOVA|||A repeated measures ANCOVA was used to test for a time by treatment condition interaction that would indicate differences between groups in change over time in the primary outcome. The null hypothesis was that there were no differences between groups in the change over time (time x treatment condition).||||0.03
72602382|NCT00205660|144734338|SUPERIORITY|||||||0.01||||||The a priori threshold for statistical significance in this planned primary test was p\<0.05.|ANCOVA|||A repeated measures ANCOVA was used to test for a time by treatment condition interaction that would indicate differences between groups in change over time in the primary outcome. The null hypothesis was that there were no differences between groups in the change over time (time x treatment condition).||||0.01
72602383|NCT00237692|144734343|SUPERIORITY_OR_OTHER||Est. % of Patients with controlled SBP|59.8|||||TWO_SIDED|95.0|55.7|63.9|||||Joint National Committee 7 blood pressure control: \< 140/90 mmHg for non-diabetics; \<130/80 mmHg for diabetics|Estimated % of participants with controlled Systolic BP at Baseline||63.9|55.7|
72602384|NCT00237692|144734343|SUPERIORITY_OR_OTHER||Est. % of patients with controled SBP|59.8|||||TWO_SIDED|95.0|55.7|64.0|||||Joint National Committee 7 blood pressure control: \< 140/90 mmHg for non-diabetics; \<130/80 mmHg for diabetics|Estimated % of participants with controlled Systolic BP at Baseline||64.0|55.7|
72602385|NCT00237692|144734343|SUPERIORITY_OR_OTHER||Est. % of patinets with controlled SBP|59.8|||||TWO_SIDED|95.0|55.6|63.9|||||Joint National Committee 7 blood pressure control: \< 140/90 mmHg for non-diabetics; \<130/80 mmHg for diabetics|Estimated % of participants with controlled BP at Baseline||63.9|55.6|
72602386|NCT00237692|144734343|SUPERIORITY_OR_OTHER||Est. % of Patients with controlled SBP|59.8|||||TWO_SIDED|95.0|55.6|63.9|||||Joint National Committee 7 blood pressure control: \< 140/90 mmHg for non-diabetics; \<130/80 mmHg for diabetics|Estimated % of participants with controlled Systolic BP at Baseline||63.9|55.6|
72602387|NCT00237692|144734344|SUPERIORITY_OR_OTHER||Est. % of Patients with controlled SBP|58.0|||||TWO_SIDED|95.0|49.3|66.7|||||Joint National Committee 7 blood pressure control: \< 140/90 mmHg for non-diabetics; \<130/80 mmHg for diabetics|Estimated % of participants with controlled Systolic BP at 6 months.||66.7|49.3|
72602388|NCT00237692|144734344|SUPERIORITY_OR_OTHER||Est. % of Patients with controlled SBP|60.9|||||TWO_SIDED|95.0|52.5|69.3|||||Joint National Committee 7 blood pressure control: \< 140/90 mmHg for non-diabetics; \<130/80 mmHg for diabetics|Estimated % of participants with controlled systolic BP at 6 months.||69.3|52.5|
72602389|NCT00237692|144734344|SUPERIORITY_OR_OTHER||Est. % of Patients with controlled SBP|65.0|||||TWO_SIDED|95.0|56.9|73.1|||||Joint National Committee 7 blood pressure control: \< 140/90 mmHg for non-diabetics; \<130/80 mmHg for diabetics|Estimated % of participants with controlled systolic BP at 6 months.||73.1|56.9|
72602390|NCT00237692|144734344|SUPERIORITY_OR_OTHER||Est. % of Patients with controlled SBP|63.8|||||TWO_SIDED|95.0|55.6|72.0|||||Joint National Committee 7 blood pressure control: \< 140/90 mmHg for non-diabetics; \<130/80 mmHg for diabetics|Estimated % of participants with controlled systolic BP at 6 months.||72.0|55.6|
72602391|NCT00237692|144734344|SUPERIORITY_OR_OTHER||% diff|2.9|||||TWO_SIDED|95.0|-9.0|14.9|||||Joint National Committee 7 blood pressure control: \< 140/90 mmHg for non-diabetics; \<130/80 mmHg for diabetics|Estimated Difference in Percentage of Patients with Controlled Systolic Blood pressure between Intervention Arm 2 - Nurse Behavioral and Arm 1 - Control at 6months.||14.9|-9.0|
72602392|NCT00237692|144734344|SUPERIORITY_OR_OTHER||% Diff|6.9|||||TWO_SIDED|95.0|-4.7|18.7|||||Joint National Committee 7 blood pressure control: \< 140/90 mmHg for non-diabetics; \<130/80 mmHg for diabetics|Estimated Difference in Percentage of Patients with Controlled Systolic Blood pressure between Intervention Arm 2 - Nurse Med Management and Arm 1 - Control at 6months.||18.7|-4.7|
72602393|NCT00237692|144734344|SUPERIORITY_OR_OTHER||% Diff|5.7|||||TWO_SIDED|95.0|-6.0|17.6||||||Estimated Difference in Percentage of Patients with Controlled Systolic Blood pressure between Intervention Arm 2 - Combined Behavioral \& Med Mgmt and Arm 1 - Control at 6months.||17.6|-6.0|
72602394|NCT00237692|144734345|SUPERIORITY_OR_OTHER||Est. % of Patients with controlled SBP|59.9|||||TWO_SIDED|95.0|51.4|68.3|||||Joint National Committee 7 blood pressure control: \< 140/90 mmHg for non-diabetics; \<130/80 mmHg for diabetics|Estimated % of participants with controlled systolic BP at 12 months.||68.3|51.4|
72602395|NCT00237692|144734345|SUPERIORITY_OR_OTHER||Est. % of Patients with controlled SBP|73.1|||||TWO_SIDED|95.0|65.6|80.7|||||Joint National Committee 7 blood pressure control: \< 140/90 mmHg for non-diabetics; \<130/80 mmHg for diabetics|Estimated % of participants with controlled systolic BP at 12 months||80.7|65.6|
72602396|NCT00237692|144734345|SUPERIORITY_OR_OTHER||Est. % of Patients with controlled SBP|73.4|||||TWO_SIDED|95.0|66.1|80.7|||||Joint National Committee 7 blood pressure control: \< 140/90 mmHg for non-diabetics; \<130/80 mmHg for diabetics|Estimated % of participants with controlled systolic BP at 12 months.||80.7|66.1|
72602397|NCT00237692|144734345|SUPERIORITY_OR_OTHER||Est. % of Patients with controlled SBP|68.6|||||TWO_SIDED|95.0|60.5|76.6|||||Joint National Committee 7 blood pressure control: \< 140/90 mmHg for non-diabetics; \<130/80 mmHg for diabetics|Estimated % of participants with controlled Systolic BP at 12 months.||76.6|60.5|
72602398|NCT00237692|144734345|SUPERIORITY_OR_OTHER||% Diff|13.2|||||TWO_SIDED|95.0|2.0|24.4||||||Estimated Difference in Percentage of Patients with Controlled Systolic Blood pressure between Intervention Arm 2 - Nurse Behavioral and Arm 1 - Control at 12 months.||24.4|2.0|
72602399|NCT00237692|144734345|SUPERIORITY_OR_OTHER||% Diff|13.5|||||TWO_SIDED|95.0|2.4|24.6||||||Estimated Difference in Percentage of Patients with Controlled Systolic Blood pressure between Intervention Arm 3 - Nurse Med Management and Arm 1 - Control at 12 months.||24.6|2.4|
72602400|NCT00237692|144734345|SUPERIORITY_OR_OTHER||% diff|8.6|||||TWO_SIDED|95.0|-2.9|20.2||||||Estimated Difference in Percentage of Patients with Controlled Systolic Blood pressure between Intervention Arm 4 - Combined Behavioral \& Med Mgmt and Arm 1 - Control at 12 months.||20.2|-2.9|
72602401|NCT00237692|144734346|SUPERIORITY_OR_OTHER||Est. % of Patients with controlled SBP|61.8|||||TWO_SIDED|95.0|53.0|70.6|||||Joint National Committee 7 blood pressure control: \< 140/90 mmHg for non-diabetics; \<130/80 mmHg for diabetics|Estimated % of participants with controlled Systolic BP at 18 months||70.6|53.0|
72602402|NCT00237692|144734346|SUPERIORITY_OR_OTHER||Est. % of Patients with controlled SBP|59.4|||||TWO_SIDED|95.0|50.8|67.9|||||Joint National Committee 7 blood pressure control: \< 140/90 mmHg for non-diabetics; \<130/80 mmHg for diabetics|Estimated % of participants with controlled BP at 18 months||67.9|50.8|
72602403|NCT00237692|144734346|SUPERIORITY_OR_OTHER||Est. % of Patients with controlled SBP|63.5|||||TWO_SIDED|95.0|55.1|72.0|||||Joint National Committee 7 blood pressure control: \< 140/90 mmHg for non-diabetics; \<130/80 mmHg for diabetics|Estimated % of participants with controlled systolic BP at 18 months.||72.0|55.1|
72602404|NCT00237692|144734346|SUPERIORITY_OR_OTHER||Est. % of Patients with controlled SBP|71.6|||||TWO_SIDED|95.0|63.7|79.5|||||Joint National Committee 7 blood pressure control: \< 140/90 mmHg for non-diabetics; \<130/80 mmHg for diabetics|Estimated % of participants with controlled systolic BP at 18 months||79.5|63.7|
72602405|NCT00237692|144734346|SUPERIORITY_OR_OTHER||% Diff|-2.4|||||TWO_SIDED|95.0|-14.6|9.7||||||Estimated Difference in Percentage of Patients with Controlled Systolic Blood pressure between Intervention Arm 2 - Nurse Behavioral and Arm 1 - Control at 18 months.||9.7|-14.6|
72602406|NCT00237692|144734346|SUPERIORITY_OR_OTHER||% Diff|1.7|||||TWO_SIDED|95.0|-10.3|13.8||||||Estimated Difference in Percentage of Patients with Controlled Systolic Blood pressure between Intervention Arm 3 - Nurse Med Management and Arm 1 - Control at 18 months.||13.8|-10.3|
72602407|NCT00237692|144734346|SUPERIORITY_OR_OTHER||% Diff|9.8|||||TWO_SIDED|95.0|-1.9|21.4||||||Estimated Difference in Percentage of Patients with Controlled Systolic Blood pressure between Intervention Arm 4 - Combined Behavioral \& Med Mgmt and Arm 1 - Control at 18 months.||21.4|-1.9|
72602408|NCT00237692|144734348|SUPERIORITY_OR_OTHER||Est. % Diff in Patient w/Controlled SBP|2.0|||||TWO_SIDED|95.0|-3.1|7.1|||||Systolic blood pressure estimates are based on the longitudinal data model with an unstructured covariance matrix. Negative differences reflect improvement compared to usual care, and positive differences reflect worsening compared to usual care.|Estimated differences in systolic blood pressure at 12months between Arm 1 - Control and Arm 2 - Nurse Behavioral||7.1|-3.1|
72552540|NCT01049334|144635895|SUPERIORITY_OR_OTHER|||||||0.0005|TWO_SIDED|95.0||||The a priori threshold for statistical significance is 0.05. Closed-sequential approach to control type I error: analyses through secondary outcomes #2-13 in the order listed will proceed until a p-value \>0.05 occurs.|Wilcoxon (Mann-Whitney)|||||||0.0005
72552541|NCT01049334|144635896|SUPERIORITY_OR_OTHER|||||||0.0005||||||The a priori threshold for statistical significance is 0.05. Closed-sequential approach to control type I error: analyses through secondary outcomes #2-13 in the order listed will proceed until a p-value \>0.05 occurs.|Wilcoxon (Mann-Whitney)|||||||0.0005
72552542|NCT01049334|144635897|SUPERIORITY_OR_OTHER|||||||0.0002||||||The a priori threshold for statistical significance is 0.05. Closed-sequential approach to control type I error: analyses through secondary outcomes #2-13 in the order listed will proceed until a p-value \>0.05 occurs.|Wilcoxon (Mann-Whitney)|||||||0.0002
72602409|NCT00237692|144734348|SUPERIORITY_OR_OTHER||Est. Dif in Patient w/Controlled DBP|0.5|||||TWO_SIDED|95.0|-2.7|3.8|||||Diastolic blood pressure estimates are based on the longitudinal data model with an unstructured covariance matrix. Negative differences reflect improvement compared to usual care, and positive differences reflect worsening compared to usual care.|Estimated differences in diastolic blood pressure at 12months between Arm 1 - Control and Arm 2 - Nurse Behavioral||3.8|-2.7|
72602410|NCT00237692|144734348|SUPERIORITY_OR_OTHER||Est. % Diff in Patient w/Controlled SBP|0.4|||||TWO_SIDED|95.0|-4.8|5.5|||||Systolic blood pressure estimates are based on the longitudinal data model with an unstructured covariance matrix. Negative differences reflect improvement compared to usual care, and positive differences reflect worsening compared to usual care.|Estimated differences in systolic blood pressure at 12months between Arm 1 - Control and Arm 3 - Nurse Med Management.||5.5|-4.8|
72602411|NCT00237692|144734348|SUPERIORITY_OR_OTHER||Est. % Diff in Patient w/Controlled DBP|0.7|||||TWO_SIDED|95.0|-2.6|4.0|||||Diastolic blood pressure estimates are based on the longitudinal data model with an unstructured covariance matrix. Negative differences reflect improvement compared to usual care, and positive differences reflect worsening compared to usual care.|Estimated differences in diastolic blood pressure at 12months between Arm 1 - Control and Arm 3 - Nuse Med Management||4.0|-2.6|
72602412|NCT00237692|144734348|SUPERIORITY_OR_OTHER||Est. % Diff in Patient w/Controlled SBP|1.6|||||TWO_SIDED|95.0|-3.3|6.6|||||Systolic blood pressure estimates are based on the longitudinal data model with an unstructured covariance matrix. Negative differences reflect improvement compared to usual care, and positive differences reflect worsening compared to usual care.|Estimated differences in systolic blood pressure at 12months between Arm 1 - Control and Arm 4 - Combined Behaviorial and Med Management||6.6|-3.3|
72602413|NCT00237692|144734348|SUPERIORITY_OR_OTHER||Est. % Diff in Patient w/Controlled DBP|3.4|||||TWO_SIDED|95.0|0.3|6.6|||||Diastolic blood pressure estimates are based on the longitudinal data model with an unstructured covariance matrix. Negative differences reflect improvement compared to usual care, and positive differences reflect worsening compared to usual care.|Estimated differences in diastolic blood pressure at 12months between Arm 1 - Control and Arm 4 - Combined Behaviorial and Med Management||6.6|0.3|
72602414|NCT02420262|144734349|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for IDegLira vs basal-bolus (IGlar + IAsp) was considered confirmed if the upper boundary of the two-sided 95% confidence interval was strictly below 0.30% or equivalent for non-inferiority using one-sided test for null hypothesis (H0): D ≥0.30% against alternative hypothesis (HA): D \<0.30% was less than or equal to 2.5%, where D is the mean treatment difference (IDegLira minus basal-bolus).|Treatment contrast|-0.02|||<|0.0001|TWO_SIDED|95.0|-0.16|0.12|||Mixed Models Analysis|||Change from baseline in HbA1c was analysed using a mixed model for repeated measurements with an unstructured covariance matrix. The model included treatment, visit and region as fixed factors and baseline HbA1c as covariate. Interactions between visit and all factors and the covariate were also included in the model.||0.12|-0.16|<0.0001
72602415|NCT02420262|144734350|SUPERIORITY_OR_OTHER||Treatment ratio|0.11|||<|0.0001|TWO_SIDED|95.0|0.08|0.17|||Negative binomial regression model||Superiority for IDegLira vs basal-bolus was considered confirmed if the 95% confidence interval for the treatment rate ratio was entirely below 1.0.|Hypoglycaemic episodes were analysed using a negative binomial regression. The model included treatment and region as fixed factors and logarithm of the time period in which a hypoglycaemic episode considered treatment emergent as offset. The test for superiority of the confirmatory secondary endpoints was carried out only if non-inferiority of IDegLira vs basal-bolus for primary endpoint was confirmed.||0.17|0.08|<0.0001
72602416|NCT02420262|144734351|SUPERIORITY_OR_OTHER||Treatment difference|-3.57|||<|0.0001|TWO_SIDED|95.0|-4.19|-2.95|||Mixed Models Analysis||Superiority for IDegLira vs basal-bolus was considered confirmed if the 95% confidence interval for the treatment difference was below 0 or equal to zero.|Body weight measurements were analysed using a linear mixed model with an unstructured covariance matrix. The model included treatment, visit and region as fixed factors and baseline bodyweight as covariate. Interactions between visit and all factors and the covariate were also included in the model. The test for superiority of the confirmatory secondary endpoints was carried out only if non-inferiority of IDegLira vs basal-bolus for primary endpoint was confirmed.||-2.95|-4.19|<0.0001
72602417|NCT00685360|144734356|SUPERIORITY||Risk Ratio Mean|1.534|||=|0.0083|TWO_SIDED|95.0|1.107|2.124|||Cochran-Mantel-Haenszel|P-value was derived using Cochran-Mantel-Haenszel (CMH) test stratified by randomization strata (cavitation).||||2.124|1.107|=0.0083
72602418|NCT00685360|144734356|SUPERIORITY||Risk Ratio Mean|1.416|||=|0.0393|TWO_SIDED|95.0|1.012|1.98||P-value was derived using CMH test stratified by randomization strata (cavitation).|Cochran-Mantel-Haenszel|||||1.980|1.012|=0.0393
72602419|NCT00685360|144734368|SUPERIORITY||Risk Ratio Mean|1.599|||=|0.0021|TWO_SIDED|95.0|1.175|2.177|||Cochran-Mantel-Haenszel|P-value was derived using CMH test stratified by randomization strata (cavitation).||||2.177|1.175|=0.0021
72602420|NCT00685360|144734368|SUPERIORITY||Risk Ratio Mean|1.939|||<|0.0001|TWO_SIDED|95.0|1.449|2.595|||Cochran-Mantel-Haenszel|||||2.595|1.449|<.0001
72602421|NCT00685360|144734369|SUPERIORITY||||||=|0.2419|TWO_SIDED||||||ANCOVA|Pairwise comparison was derived from analysis of covariance(ANCOVA)model with factors of treatment, baseline cavitation status and covariate baseline.||||||=0.2419
72602422|NCT00685360|144734369|SUPERIORITY||||||=|0.2239|TWO_SIDED||||||ANCOVA|Pairwise comparison is derived from ANCOVA model with factors of treatment, baseline cavitation status and covariate baseline.||||||=0.2239
72602423|NCT00685360|144734369|SUPERIORITY||||||=|0.9544|TWO_SIDED||||||ANCOVA|Pairwise comparison is derived from ANCOVA model with factors of treatment, baseline cavitation status and covariate baseline.||||||=0.9544
72602424|NCT00685360|144734370|SUPERIORITY||||||=|0.0246|TWO_SIDED||||||ANCOVA|Pairwise comparison was derived from ANCOVA model with factors of treatment, baseline cavitation status and covariate baseline.||||||=0.0246
72602425|NCT00685360|144734370|SUPERIORITY||||||=|0.0529|TWO_SIDED||||||ANCOVA|Pairwise comparison was derived from ANCOVA model with factors of treatment, baseline cavitation status and covariate baseline.||||||=0.0529
72602426|NCT00685360|144734370|SUPERIORITY||||||=|0.7508|TWO_SIDED||||||ANCOVA|Pairwise comparison was derived from ANCOVA model with factors of treatment, baseline cavitation status and covariate baseline.||||||=0.7508
72602427|NCT00685360|144734371|SUPERIORITY||Risk Ratio Mean|1.272|||=|0.0518|TWO_SIDED|95.0|0.995|1.627|||Cochran-Mantel-Haenszel|P-value was derived using CMH test stratified by randomization strata (cavitation).||||1.627|0.995|=0.0518
72602428|NCT00685360|144734371|SUPERIORITY||Risk Ratio Mean|1.203|||=|0.1506|TWO_SIDED|95.0|0.934|1.55|||Cochran-Mantel-Haenszel|P-value was derived using CMH test stratified by randomization strata (cavitation).||||1.550|0.934|=0.1506
72602429|NCT00685360|144734372|SUPERIORITY||Risk Ratio Mean|1.234|||=|0.1201|TWO_SIDED|95.0|0.945|1.612|||Cochran-Mantel-Haenszel|P-value was derived using CMH test stratified by randomization strata (cavitation).||||1.612|0.945|=0.1201
72602430|NCT00685360|144734372|SUPERIORITY||Risk Ratio Mean|1.099|||=|0.5112|TWO_SIDED|95.0|0.829|1.456|||Cochran-Mantel-Haenszel|P-value was derived using CMH test stratified by randomization strata (cavitation).||||1.456|0.829|=0.5112
72602431|NCT00685360|144734373|SUPERIORITY||Risk Ratio Mean|1.323|||=|0.0141|TWO_SIDED|95.0|1.053|1.661|||Cochran-Mantel-Haenszel|P-value was derived using CMH test stratified by randomization strata (cavitation).||||1.661|1.053|=0.0141
72602432|NCT00685360|144734373|SUPERIORITY||Risk Ratio Mean|1.438|||=|0.0008|TWO_SIDED|95.0|1.155|1.791|||Cochran-Mantel-Haenszel|P-value was derived using CMH test stratified by randomization strata (cavitation).||||1.791|1.155|=0.0008
72602433|NCT00685360|144734374|SUPERIORITY||Risk Ratio Mean|1.341|||=|0.0196|TWO_SIDED|95.0|1.044|1.722|||Cochran-Mantel-Haenszel|P-value was derived using CMH test stratified by randomization strata (cavitation).||||1.722|1.044|=0.0196
72602434|NCT00685360|144734374|SUPERIORITY||Risk Ratio Mean|1.503|||=|0.0006|TWO_SIDED|95.0|1.183|1.909|||Cochran-Mantel-Haenszel|P-value was derived using CMH test stratified by randomization strata (cavitation).||||1.909|1.183|=0.0006
72602435|NCT00685360|144734375|SUPERIORITY||||||=|0.0468|||||||Cochran-Armitage Linear Trend Test|Cochran-Armitage test was performed for dose response with the treatment group ordered as placebo, delamanid 100 mg BID, and delamanid 200 mg BID.||||||=0.0468
72602436|NCT00685360|144734376|SUPERIORITY||Hazard Ratio (HR)|1.856|||=|0.0011|TWO_SIDED|95.0|1.255|2.745|||Stratified Log-Rank Test|p-value was derived from log-rank test with SAS Proc lifetest for comparisons with placebo.|Hazard ratio computed with SAS PROC PHREG for comparisons with placebo.|||2.745|1.255|=0.0011
72602437|NCT00685360|144734376|SUPERIORITY||Hazard Ratio (HR)|1.849|||=|0.0013|TWO_SIDED|95.0|1.246|2.743|||Stratified Log-Rank Test|p-value was derived from log-rank test with SAS Proc lifetest for comparisons with placebo.|Hazard ratio computed with SAS PROC PHREG for comparisons with placebo.|||2.743|1.246|=0.0013
72602438|NCT00685360|144734377|SUPERIORITY||Hazard Ratio (HR)|1.926|||=|0.0004|TWO_SIDED|95.0|1.315|2.82|||Stratified Log-Rank Test|P-value was derived from Log-rank test with SAS PROC LIFETEST for comparisons with placebo.|Hazard ratio computed with SAS PROC PHREG for comparisons with placebo.|||2.820|1.315|=0.0004
72602439|NCT00685360|144734377|SUPERIORITY||Hazard Ratio (HR)|2.19|||<|0.0001|TWO_SIDED|95.0|1.504|3.189|||Stratified Log-Rank Test|||||3.189|1.504|<.0001
72602440|NCT00685360|144734378|SUPERIORITY||Hazard Ratio (HR)|1.727|||=|0.0056|TWO_SIDED|95.0|1.152|2.591|||Stratified Log-Rank Test|P-value was derived from Log-rank test with SAS PROC LIFETEST for comparisons with placebo.|Hazard ratio computed with SAS PROC PHREG for comparisons with placebo.|||2.591|1.152|=0.0056
72602441|NCT00685360|144734378|SUPERIORITY||Hazard Ratio (HR)|1.585|||=|0.0232|TWO_SIDED|95.0|1.048|2.399|||Stratified Log-Rank Test|P-value was derived from Log-rank test with SAS PROC LIFETEST for comparisons with placebo.|Hazard ratio computed with SAS PROC PHREG for comparisons with placebo.|||2.399|1.048|=0.0232
72602442|NCT00685360|144734379|SUPERIORITY||Hazard Ratio (HR)|1.846|||=|0.0016|TWO_SIDED|95.0|1.235|2.759|||Stratified Log-Rank Test|P-value was derived from log-rank test with SAS PROC LIFETEST for comparisons with placebo.|Hazard ratio computed with SAS PROC PHREG for comparisons with placebo.|||2.759|1.235|=0.0016
72602443|NCT00685360|144734379|SUPERIORITY||Hazard Ratio (HR)|2.301|||<|0.0001|TWO_SIDED|95.0|1.555|3.405|||Stratified Log-Rank Test|P-value was derived from Log-rank test with SAS PROC LIFETEST for comparisons with placebo.|Hazard ratio computed with SAS PROC PHREG for comparisons with placebo.|||3.405|1.555|<.0001
72602444|NCT04208412|144734405|SUPERIORITY|||||||0.001|||||||Wilcoxon Test (Gehan's Generalized)|||||||0.0010
72602445|NCT04208412|144734406|SUPERIORITY|||||||0.0045|||||||Prescott's Test|||||||0.0045
72602446|NCT04208412|144734407|SUPERIORITY||||||<|0.0001|||||||Wilcoxon Test (Gehan's Generalized)|||"Gehan's Generalized Wilcoxon Test:~600 mg KVD900 vs Placebo"||||<0.0001
72602447|NCT04208412|144734408|SUPERIORITY||||||<|0.0001|||||||Wilcoxon Test (Gehan's Generalized)|||||||<0.0001
72602448|NCT04208412|144734409|SUPERIORITY||||||<|0.0001|||||||Wilcoxon Test (Gehan's Generalized)|||||||<0.0001
72602449|NCT01904032|144734420|SUPERIORITY||Mean Difference (Final Values)|0.7982|STANDARD_ERROR_OF_MEAN|2.0537||0.6982|TWO_SIDED|95.0|-3.2691|4.8656|||t-test, 2 sided|||The null hypothesis is that there is no difference in the CES-D change score between women who received high dose Vitamin D therapy versus low dose Vitamin D therapy.||4.8656|-3.2691|.6982
72602450|NCT01904032|144734421|SUPERIORITY||Mean Difference (Final Values)|-0.0424|STANDARD_ERROR_OF_MEAN|3.6619||0.9908|TWO_SIDED|95.0|-7.2946|7.2097|||t-test, 2 sided|||The null hypothesis is that there is no difference in the PAID change score between women who received high dose Vitamin D therapy versus low dose Vitamin D therapy.||7.2097|-7.2946|.9908
72416237|NCT01972841|144343299|SUPERIORITY||Rate ratio|0.88|STANDARD_ERROR_OF_MEAN|0.1||0.172|TWO_SIDED|95.0|0.73|1.06|||Negative binomial regression|||Rate ratio of number of incontinence episodes during the 7-day diary between the given combination group and the given monotherapy group calculated from a negative binomial regression model incl. treatment group, sex, age group (\<65, ≥65 years), geographic region and previous OAB medication (yes, no) as factors, log(number of incontinence episodes used divided by number of valid diary days) at baseline included as a covariate and number of valid diary days at EoT as the offset variable.||1.06|0.73|0.172
72602451|NCT01904032|144734422|SUPERIORITY||Mean Difference (Final Values)|0.4966|STANDARD_ERROR_OF_MEAN|3.1474||0.8749|TWO_SIDED|95.0|-5.7366|6.7298|||t-test, 2 sided|||The null hypothesis is that there is no difference in the change in systolic blood pressure between women who received high dose Vitamin D therapy versus low dose Vitamin D therapy.||6.7298|-5.7366|.8749
72602452|NCT01904032|144734423|SUPERIORITY||Mean Difference (Final Values)|1.5125|STANDARD_ERROR_OF_MEAN|1.8636||0.4187|TWO_SIDED|95.0|-2.1784|5.2033|||t-test, 2 sided|||The null hypothesis is that there is no difference in the change in diastolic blood pressure between women who received high dose Vitamin D therapy versus low dose Vitamin D therapy.||5.2033|-2.1784|.4187
72602453|NCT01903993|144734479|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.69|||=|0.0106|TWO_SIDED|95.0|0.52|0.92|||Log rank (Stratified)|||Hazard ratios (HR) were estimated by a Cox regression model.||0.92|0.52|= 0.0106
72602454|NCT01903993|144734480|SUPERIORITY_OR_OTHER_LEGACY||Difference in Response Rates|0.59|||=|0.8884|TWO_SIDED|95.0|-7.67|8.85|||Cochran-Mantel-Haenszel|||||8.85|-7.67|= 0.8884
72602455|NCT01903993|144734481|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.92|||=|0.5563|TWO_SIDED|95.0|0.71|1.2|||Log rank (Stratified)|||HR were estimated by a Cox regression model. The two treatment comparison was based on a stratified log-rank test.||1.20|0.71|=0.5563
72602456|NCT01903993|144734482|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.32|||=|0.0028|TWO_SIDED|95.0|0.15|0.7|||Log rank (unstratified)|||HR were estimated by a unstratified Cox regression model.||0.70|0.15|= 0.0028
72602457|NCT01868165|144734498|OTHER||Slope|0.58|||||TWO_SIDED|95.0|-0.6|1.77|||||"Linear regression slope and 95% confidence intervals for the association between calcium channel blocker use and cognitive change was 0.58 (-0.60:1.77).~Multiple adjustments including; age, sex, education."|||1.77|-0.60|
72602458|NCT03373461|144734560|OTHER|||||||0.038|||||||Multiple Comparison Procedure-Modeling|||||||0.038
72602459|NCT03373461|144734560|OTHER||Ratio to placebo (of ratio to baseline)|0.99|||||TWO_SIDED|80.0|0.86|1.0||||||||1.00|0.86|
72602460|NCT03373461|144734560|OTHER||Ratio to placebo (of ratio to baseline)|0.94|||||TWO_SIDED|80.0|0.76|0.98||||||||0.98|0.76|
72602461|NCT03373461|144734560|OTHER||Ratio to placebo (of ratio to baseline)|0.87|||||TWO_SIDED|80.0|0.72|0.96||||||||0.96|0.72|
72602462|NCT03373461|144734560|OTHER||Ratio to placebo (of ratio to baseline)|0.77|||||TWO_SIDED|80.0|0.66|0.92||||||||0.92|0.66|
72602463|NCT03373461|144734561|OTHER||Mean Difference (Final Values)|3.28|||||TWO_SIDED|80.0|0.21|6.344||||||||6.344|0.210|
72602464|NCT03373461|144734561|OTHER||Mean Difference (Final Values)|5.83|||||TWO_SIDED|80.0|2.642|9.01||||||||9.010|2.642|
72602465|NCT03373461|144734561|OTHER||Mean Difference (Final Values)|3.56|||||TWO_SIDED|80.0|0.427|6.7||||||||6.700|0.427|
72602466|NCT03373461|144734561|OTHER||Mean Difference (Final Values)|5.76|||||TWO_SIDED|80.0|2.882|8.638||||||||8.638|2.882|
72602467|NCT03373461|144734562|OTHER||Mean Difference (Final Values)|-9.2|||||TWO_SIDED|80.0|-15.253|-3.145||||||||-3.145|-15.253|
72602468|NCT03373461|144734562|OTHER||Mean Difference (Final Values)|-9.25|||||TWO_SIDED|80.0|-15.499|-3.0||||||||-3.000|-15.499|
72602469|NCT03373461|144734562|OTHER||Mean Difference (Final Values)|-5.89|||||TWO_SIDED|80.0|-12.04|0.26||||||||0.260|-12.040|
72602470|NCT03373461|144734562|OTHER||Mean Difference (Final Values)|-10.12|||||TWO_SIDED|80.0|-15.763|-4.471||||||||-4.471|-15.763|
72602471|NCT03373461|144734564|OTHER||Ratio to placebo (of ratio to baseline)|0.95|||||TWO_SIDED|80.0|0.742|1.222||||||||1.222|0.742|
72602472|NCT03373461|144734564|OTHER||Ratio to placebo (of ratio to baseline)|1.06|||||TWO_SIDED|80.0|0.83|1.356||||||||1.356|0.830|
72602473|NCT03373461|144734564|OTHER||Ratio to placebo (of ratio to baseline)|0.73|||||TWO_SIDED|80.0|0.569|0.928||||||||0.928|0.569|
72602474|NCT03373461|144734564|OTHER||Ratio to placebo (of ratio to baseline)|0.84|||||TWO_SIDED|80.0|0.669|1.05||||||||1.050|0.669|
72602475|NCT03373461|144734565|OTHER||Ratio to placebo (of ratio to baseline)|0.96|||||TWO_SIDED|80.0|0.741|1.25||||||||1.250|0.741|
72602476|NCT03373461|144734565|OTHER||Ratio to placebo (of ratio to baseline)|1.13|||||TWO_SIDED|80.0|0.872|1.458||||||||1.458|0.872|
72602477|NCT03373461|144734565|OTHER||Ratio to placebo (of ratio to baseline)|0.74|||||TWO_SIDED|80.0|0.574|0.957||||||||0.957|0.574|
72602478|NCT03373461|144734565|OTHER||Ratio to placebo (of ratio to baseline)|0.89|||||TWO_SIDED|80.0|0.706|1.132||||||||1.132|0.706|
72602479|NCT03373461|144734566|OTHER||Ratio to placebo (of ratio to baseline)|0.98|||||TWO_SIDED|80.0|0.794|1.214||||||||1.214|0.794|
72602480|NCT03373461|144734566|OTHER||Ratio to placebo (of ratio to baseline)|1.03|||||TWO_SIDED|80.0|0.835|1.269||||||||1.269|0.835|
72602481|NCT03373461|144734566|OTHER||Ratio to placebo (of ratio to baseline)|0.76|||||TWO_SIDED|80.0|0.616|0.942||||||||0.942|0.616|
72602482|NCT03373461|144734566|OTHER||Ratio to placebo (of ratio to baseline)|0.85|||||TWO_SIDED|80.0|0.704|1.027||||||||1.027|0.704|
72602483|NCT03373461|144734567|OTHER||Ratio to placebo (of ratio to baseline)|0.92|||||TWO_SIDED|80.0|0.723|1.172||||||||1.172|0.723|
72602484|NCT03373461|144734567|OTHER||Ratio to placebo (of ratio to baseline)|0.98|||||TWO_SIDED|80.0|0.767|1.249||||||||1.249|0.767|
72602485|NCT03373461|144734567|OTHER||Ratio to placebo (of ratio to baseline)|0.74|||||TWO_SIDED|80.0|0.577|0.937||||||||0.937|0.577|
72602486|NCT03373461|144734567|OTHER||Ratio to placebo (of ratio to baseline)|0.84|||||TWO_SIDED|80.0|0.678|1.052||||||||1.052|0.678|
72602487|NCT03373461|144734576|OTHER||Mean Difference (Final Values)|3.95|||||TWO_SIDED|80.0|0.42|7.472||||||||7.472|0.420|
72602488|NCT03373461|144734576|OTHER||Mean Difference (Final Values)|0.82|||||TWO_SIDED|80.0|-2.747|4.39||||||||4.390|-2.747|
72602489|NCT03373461|144734576|OTHER||Mean Difference (Final Values)|0.26|||||TWO_SIDED|80.0|-2.745|3.262||||||||3.262|-2.745|
72602490|NCT03373461|144734576|OTHER||Mean Difference (Final Values)|1.98|||||TWO_SIDED|80.0|-1.368|5.337||||||||5.337|-1.368|
72602491|NCT03373461|144734577|OTHER||Ratio to placebo (of ratio to baseline)|1.04|||||TWO_SIDED|80.0|0.68|1.579||||||||1.579|0.680|
72602492|NCT03373461|144734577|OTHER||Ratio to placebo (of ratio to baseline)|0.92|||||TWO_SIDED|80.0|0.607|1.39||||||||1.390|0.607|
72602493|NCT03373461|144734577|OTHER||Ratio to placebo (of ratio to baseline)|0.8|||||TWO_SIDED|80.0|0.558|1.153||||||||1.153|0.558|
72602494|NCT03373461|144734577|OTHER||Ratio to placebo (of ratio to baseline)|0.91|||||TWO_SIDED|80.0|0.614|1.362||||||||1.362|0.614|
72602495|NCT03373461|144734579|OTHER||Geometric mean ratio|1.16|||||TWO_SIDED|80.0|0.792|1.692||||||||1.692|0.792|
72602496|NCT03373461|144734579|OTHER||Geometric mean ratio|0.65|||||TWO_SIDED|80.0|0.446|0.945||||||||0.945|0.446|
72602497|NCT03373461|144734579|OTHER||Geometric mean ratio|0.72|||||TWO_SIDED|80.0|0.518|0.997||||||||0.997|0.518|
72602498|NCT03373461|144734579|OTHER||Geometric mean ratio|0.8|||||TWO_SIDED|80.0|0.558|1.146||||||||1.146|0.558|
72602499|NCT03373461|144734580|OTHER||Ratio to placebo (of ratio to baseline)|1.14|||||TWO_SIDED|80.0|0.765|1.699||||||||1.699|0.765|
72602500|NCT03373461|144734580|OTHER||Ratio to placebo (of ratio to baseline)|0.66|||||TWO_SIDED|80.0|0.446|0.984||||||||0.984|0.446|
72602501|NCT03373461|144734580|OTHER||Ratio to placebo (of ratio to baseline)|0.71|||||TWO_SIDED|80.0|0.501|0.995||||||||0.995|0.501|
72602502|NCT03373461|144734580|OTHER||Ratio to placebo (of ratio to baseline)|0.76|||||TWO_SIDED|80.0|0.52|1.107||||||||1.107|0.520|
72602503|NCT01919164|144734611|SUPERIORITY||Mean Difference (Final Values)|0.01|||||TWO_SIDED|95.0|-0.01|0.03||||||Descriptive statistics was provided for primary endpoint.||0.03|-0.01|
72602504|NCT01919164|144734611|SUPERIORITY||Mean Difference (Final Values)|0.02|||||TWO_SIDED|95.0|-0.01|0.04||||||Descriptive statistics was provided for primary endpoint.||0.04|-0.01|
72602505|NCT01919164|144734611|SUPERIORITY||Mean Difference (Final Values)|0.04|||||TWO_SIDED|95.0|0.02|0.06||||||Descriptive statistics was provided for primary endpoint.||0.06|0.02|
72602506|NCT01919164|144734611|SUPERIORITY||Mean Difference (Final Values)|0.05|||||TWO_SIDED|95.0|0.03|0.07||||||Descriptive statistics was provided for primary endpoint.||0.07|0.03|
72602507|NCT03442725|144734625|OTHER||Geometric Mean Ratio|1.297|||||TWO_SIDED|90.0|0.6|2.805||||||Analysis of variance (ANOVA) comparison of Cmax for telotristat ethyl between test group versus the control group.||2.805|0.600|
72602508|NCT03442725|144734625|OTHER||Geometric Mean Ratio|1.423|||||TWO_SIDED|90.0|0.901|2.247||||||ANOVA comparison of Cmax for LP-778902 between test group versus the control group.||2.247|0.901|
72602509|NCT03442725|144734626|OTHER|Estimate of the median difference and 90% confidence intervals (CIs) was determined by Hodges-Lehmann estimation.|Median Difference|0.0||||0.7452|TWO_SIDED|90.0|-1.0|0.95|||Wilcoxon (Mann-Whitney)|||Comparison of tmax for telotristat ethyl between test group versus the control group.||0.950|-1.000|0.7452
72602510|NCT03442725|144734626|OTHER|Estimate of the median difference and 90% CIs was determined by Hodges-Lehmann estimation.|Median Difference|0.0||||0.7039|TWO_SIDED|90.0|-1.0|1.0|||Wilcoxon (Mann-Whitney)|||Comparison of tmax for LP-778902 between test group versus the control group.||1.000|-1.000|0.7039
72602511|NCT03442725|144734628|OTHER||Geometric Mean Ratio|1.506|||||TWO_SIDED|90.0|0.914|2.48||||||ANOVA comparison of AUC0-inf for LP-778902 between test group versus the control group.||2.480|0.914|
72602512|NCT03442725|144734629|OTHER||Geometric Mean Ratio|1.512|||||TWO_SIDED|90.0|0.915|2.498||||||ANOVA comparison of AUC0-tlast for LP-778902 between test group versus the control group.||2.498|0.915|
72602513|NCT03442725|144734633|OTHER||Arithmetic Mean Difference|0.019|||||TWO_SIDED|90.0|-0.03|0.068||||||ANOVA comparison of fu of LP-778902 between test group versus the control group.||0.068|-0.030|
72602514|NCT03442725|144734634|OTHER||Geometric Mean Ratio|1.727|||||TWO_SIDED|90.0|0.866|3.443||||||ANOVA comparison of Cmaxu for LP-778902 between test group versus the control group.||3.443|0.866|
72602515|NCT03442725|144734635|OTHER||Geometric Mean Ratio|1.828|||||TWO_SIDED|90.0|0.903|3.699||||||ANOVA comparison of AUC0-infu for LP-778902 between test group versus the control group.||3.699|0.903|
72602516|NCT03442725|144734636|OTHER||Geometric Mean Ratio|1.835|||||TWO_SIDED|90.0|0.904|3.726||||||ANOVA comparison of AUC0-tlastu for LP-778902 between test group versus the control group.||3.726|0.904|
72602517|NCT01431313|144734654|OTHER|Mixed effects model across all time points.||||||0.002|||||||Mixed Models Analysis|||||||0.002
72602518|NCT01431313|144734654|OTHER|Mixed effects model across all time points.||||||0.003|||||||Mixed Models Analysis|||||||0.003
72602519|NCT01431313|144734654|OTHER|Mixed effects model across all time points.||||||0.66|||||||Mixed Models Analysis|||||||0.66
72602520|NCT01431313|144734656|OTHER|Mixed effects model across all time points.|||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
72602521|NCT01431313|144734656|OTHER|Mixed effects model across all time points.|||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
72602522|NCT01431313|144734656|OTHER|Mixed effects model across all time points.|||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
72602523|NCT01431313|144734657|OTHER|Mixed effects model across all time points.||||||0.8|||||||Mixed Models Analysis|||||||0.8
72602524|NCT01431313|144734657|OTHER|Mixed effects model across all time points.||||||0.01|||||||Mixed Models Analysis|||||||0.01
72602525|NCT01431313|144734657|OTHER|Mixed effects model across all time points.||||||0.01|||||||Mixed Models Analysis|||||||0.01
72602526|NCT01431313|144734658|SUPERIORITY|||||||0.5|||||||Wilcoxon (Mann-Whitney)|||||||0.5
72602527|NCT01431313|144734658|SUPERIORITY|||||||0.04|||||||Wilcoxon (Mann-Whitney)|||||||0.04
72602528|NCT01431313|144734658|SUPERIORITY|||||||0.17|||||||Wilcoxon (Mann-Whitney)|||||||0.17
72602529|NCT01431313|144734659|OTHER|Mixed effects model of concentrations measured at Pre-dose, 15 minutes post 45mg dose and 15 minutes post 90mg dose.|||||<|0.05|||||||Mixed Models Analysis|||||||<0.05
72602530|NCT01431313|144734659|OTHER|Mixed effects model of concentrations measured at Pre-dose, 15 minutes post 45mg dose and 15 minutes post 90mg dose.|||||<|0.05|||||||Mixed Models Analysis|||||||<0.05
72602531|NCT01431313|144734659|OTHER|Mixed effects model of concentrations measured at Pre-dose, 15 minutes post 45mg dose and 15 minutes post 90mg dose.|||||<|0.05|||||||Mixed Models Analysis|||||||<0.05
72602532|NCT01431313|144734660|OTHER|Mixed effects model of concentrations measured at Pre-dose, 15 minutes post 45mg dose and 15 minutes post 90mg dose.|||||<|0.05|||||||Mixed Models Analysis|||||||<0.05
72602533|NCT01431313|144734660|OTHER|Mixed effects model of concentrations measured at Pre-dose, 15 minutes post 45mg dose and 15 minutes post 90mg dose.|||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
72602534|NCT01431313|144734661|OTHER|Mixed effects model across all doses.|||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
72602535|NCT01431313|144734661|OTHER|Mixed effects model across all doses.||||||0.21|||||||Mixed Models Analysis|||||||0.21
72602536|NCT01431313|144734661|OTHER|Mixed effects model across all doses.||||||0.59|||||||Mixed Models Analysis|||||||0.59
72602537|NCT01990573|144734665|OTHER|ANOVA|F statistic|0.002||||0.002|TWO_SIDED||||||ANOVA|||||||.002
72602538|NCT01990573|144734666|OTHER|ANOVA|F statistic|0.962||||0.962|TWO_SIDED||||||ANOVA|||||||.962
72602539|NCT02256917|144734692|OTHER|Confirmative one-sided one-sample Poisson-test.|ABR|4.87|||||TWO_SIDED|95.0|4.06|5.79||A respective confirmative one-sided one-sample Poisson-test was used to demonstrate if the mean ABR in patients with individually tailored prophylaxis is at least 50% below the mean ABR rate in the GENA-01 trial.|one-sided one-sample Poisson-test||A confidence interval of 97.5% for confirmative analysis was also used - the respective upper and lower limit CIs were 3.96-5.93|||5.79|4.06|
72602540|NCT02256917|144734692|OTHER|Reduction of the annualized total bleeding rate (ABR) observed in the GENA-01 study vs. GENA-21B analyzed with a Negative Binomial regression model including a correction for overdispersion.|Rate ratio|11.89|||<|0.0001|TWO_SIDED|95.0|7.5|18.86|||Negative binomial regression model|||||18.86|7.50|<0.0001
72602541|NCT02256917|144734692|OTHER|Reduction of the annualized total bleeding rate (ABR) observed in the GENA-01 study vs. GENA-21B analyzed with a Poisson regression model including a correction for overdispersion.|Rate ratio|10.14|||<|0.0001|TWO_SIDED|95.0|6.12|16.8|||Poisson regression model|||||16.80|6.12|<0.0001
72602542|NCT02256917|144734693|OTHER|A respective confirmative one-sided one-sample Poisson-test was used to demonstrate if the mean spontaneous ABR in patients with individually tailored prophylaxis is at least 50% below the mean ABR rate in the GENA-01 trial.|ABR|3.12|||||TWO_SIDED|95.0|2.48|3.87|||One-sided one-sample Poisso|||||3.87|2.48|
72602543|NCT02256917|144734694|OTHER|A respective confirmative one-sided one-sample Poisson-test was used to demonstrate if the mean ABR in patients with 2x/week prophylaxis or less with individually tailored prophylaxis is at least 50% below the mean ABR rate in the GENA-01 trial.|ABR|5.03|||||TWO_SIDED|95.0|3.9|6.39|||One-sided one-sample Poisson-test||A confidence interval of 97.5% for confirmative analysis was also used - the respective upper and lower limit CIs were 3.76-6.60|||6.39|3.90|
72602544|NCT00872521|144734710|SUPERIORITY_OR_OTHER|||||||0.09|TWO_SIDED||||||Chi-squared|||Null Hypothesis: There is no difference in response rate between 1q21 amplified and 1q21 NOT amplified||||0.09
72602545|NCT00872521|144734711|SUPERIORITY_OR_OTHER|||||||0.23|||||||Chi-squared|||Null Hypothesis: There is no difference in response rate between 1q21 amplified and 1q21 NOT amplified||||0.23
72602546|NCT00872521|144734712|SUPERIORITY_OR_OTHER|||||||0.23|TWO_SIDED||||||Chi-squared|||Null Hypothesis: There is no difference in response rate between 1q21 amplified and 1q21 NOT amplified||||0.23
72602547|NCT00872521|144734713|SUPERIORITY_OR_OTHER|||||||0.56|||||||Chi-squared|||Null Hypothesis: There is no difference in response rate between 1q21 amplified and 1q21 NOT amplified||||0.56
72602548|NCT00872521|144734714|SUPERIORITY_OR_OTHER|||||||0.01|||||||Log Rank|||Null Hypothesis: There is no difference in response rate between 1q21 amplified and 1q21 NOT amplified||||0.01
72602549|NCT00872521|144734715|SUPERIORITY_OR_OTHER|||||||0.28|||||||Log Rank|||Null Hypothesis: There is no difference in response rate between 1q21 amplified and 1q21 NOT amplified||||0.28
72602550|NCT04819438|144734745|EQUIVALENCE|Acceptance criterion for bioequivalence analysis was that the 90% confidence interval for the Test/Reference ratio of Cmax geometric means was within the 80.00-125.00 range.|Geometric Mean Ratio|117.05|||<|0.0001|TWO_SIDED|90.0|110.43|124.06|||ANOVA|||||124.06|110.43|<0.0001
72602551|NCT04819438|144734746|EQUIVALENCE|Acceptance criterion for bioequivalence analysis was that the 90% confidence interval for the Test/Reference ratio of AUC0-t geometric means was within the 80.00-125.00 range.|Geometric Mean Ratio|111.82|||<|0.0001|TWO_SIDED|90.0|108.25|115.5|||ANOVA|||||115.50|108.25|<0.0001
72602552|NCT04819438|144734748|EQUIVALENCE|Acceptance criterion for bioequivalence analysis was that the 90% confidence interval for the Test/Reference ratio of AUC0-∞ geometric means was within the 80.00-125.00 range.|Geometric Mean Ratio|111.83|||<|0.0001|TWO_SIDED|90.0|108.19|115.29|||ANOVA|||||115.29|108.19|<0.0001
72602553|NCT03060291|144734770|SUPERIORITY||Mean Difference (Final Values)|0.07||||0.549|TWO_SIDED||||||t-test, 2 sided||Mean difference in slope with the wait-list control as the reference group.|||||.549
72602554|NCT03060291|144734770|SUPERIORITY||Mean Difference (Final Values)|-0.02||||0.854|TWO_SIDED||||||t-test, 2 sided||Mean difference in slope with the wait-list control as the reference group.|||||.854
72602555|NCT03060291|144734770|SUPERIORITY||Mean Difference (Final Values)|-0.09||||0.469|TWO_SIDED||||||t-test, 2 sided||Mean difference in slope with the web/mobile only as the reference group.|||||.469
72602556|NCT03060291|144734771|SUPERIORITY||Mean Difference (Final Values)|0.03||||0.535|TWO_SIDED||||||t-test, 2 sided||Mean difference in slope with the wait-list control as the reference group.|||||.535
72602557|NCT03060291|144734771|SUPERIORITY||Mean Difference (Final Values)|0.08||||0.081|TWO_SIDED||||||t-test, 2 sided||Mean difference in slope with the wait-list control as the reference group.|||||.081
72602558|NCT03060291|144734771|SUPERIORITY||Mean Difference (Final Values)|0.05||||0.295|TWO_SIDED||||||t-test, 2 sided||Mean difference in slope with the web/mobile only as the reference group.|||||.295
72602559|NCT03060291|144734772|SUPERIORITY||Mean Difference (Final Values)|0.11||||0.149|TWO_SIDED||||||t-test, 2 sided||Mean difference in slope with the wait-list control as the reference group.|||||.149
72602560|NCT03060291|144734772|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.207|TWO_SIDED||||||t-test, 2 sided||Mean difference in slope with the wait-list control as the reference group.|||||.207
72602561|NCT03060291|144734772|SUPERIORITY||Mean Difference (Final Values)|-0.01||||0.871|TWO_SIDED||||||t-test, 2 sided||Mean difference in slope with the web/mobile only as the reference group.|||||.871
72602562|NCT03060291|144734773|SUPERIORITY||Mean Difference (Final Values)|0.06||||0.547|TWO_SIDED||||||t-test, 2 sided||Mean difference in slope with the wait-list control as the reference group.|||||.547
72602563|NCT03060291|144734773|SUPERIORITY||Mean Difference (Final Values)|0.06||||0.575|TWO_SIDED||||||t-test, 2 sided||Mean difference in slope with the wait-list control as the reference group.|||||.575
72602564|NCT03060291|144734773|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.964|TWO_SIDED||||||t-test, 2 sided||Mean difference in slope with the web/mobile only as the reference group.|||||.964
72602565|NCT03060291|144734774|SUPERIORITY||Mean Difference (Final Values)|0.04||||0.236|TWO_SIDED||||||t-test, 2 sided||Mean difference in slope with the wait-list control as the reference group.|||||.236
72602566|NCT03060291|144734774|SUPERIORITY||Mean Difference (Final Values)|0.05||||0.142|TWO_SIDED||||||t-test, 2 sided||Mean difference in slope with the wait-list control as the reference group.|||||.142
72602567|NCT03060291|144734774|SUPERIORITY||Mean Difference (Final Values)|0.01||||0.81|TWO_SIDED||||||t-test, 2 sided||Mean difference in slope with the web/mobile only as the reference group.|||||.810
72602568|NCT03060291|144734775|SUPERIORITY||Mean Difference (Final Values)|-0.17||||0.599|TWO_SIDED||||||t-test, 2 sided||Mean difference in slope with the wait-list control as the reference group.|||||.599
72602569|NCT03060291|144734775|SUPERIORITY||Mean Difference (Final Values)|0.22||||0.523|TWO_SIDED||||||t-test, 2 sided||Mean difference in slope with the wait-list control as the reference group.|||||.523
72602570|NCT03060291|144734775|SUPERIORITY||Mean Difference (Final Values)|0.36||||0.252|TWO_SIDED||||||t-test, 2 sided||Mean difference in slope with the web/mobile only as the reference group.|||||.252
72602571|NCT03060291|144734776|SUPERIORITY||Mean Difference (Final Values)|0.06||||0.867|TWO_SIDED||||||t-test, 2 sided||Mean difference in slope with the wait-list control as the reference group.|||||.867
72602572|NCT03060291|144734776|SUPERIORITY||Mean Difference (Final Values)|-0.47||||0.127|TWO_SIDED||||||t-test, 2 sided||Mean difference in slope with the wait-list control as the reference group.|||||.127
72602573|NCT03060291|144734776|SUPERIORITY||Mean Difference (Final Values)|-0.51||||0.101|TWO_SIDED||||||t-test, 2 sided||||Mean difference in slope with the web/mobile only as the reference group.|||.101
72602574|NCT00996034|144734785|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||ANOVA|||This is a comparison of scan 1 and scan 2||||<0.05
72602575|NCT00158262|144734786|SUPERIORITY||Mean Difference (Final Values)|7.0|||||TWO_SIDED|95.0|-2.7|16.7|||||Placebo-Propranolol|||16.7|-2.7|
72602576|NCT00158262|144734787|SUPERIORITY||Mean Difference (Final Values)|0.0|||||TWO_SIDED|95.0|-15.5|15.3|||||Placebo-Propranolol|CAPS Total Score at Month 1||15.3|-15.5|
72602577|NCT00158262|144734787|SUPERIORITY||Mean Difference (Final Values)|-2.2|||||TWO_SIDED|95.0|-20.3|16.0||||||CAPS Total Score at Month 3||16.0|-20.3|
72602578|NCT00158262|144734788|SUPERIORITY||Mean Difference (Final Values)|2.9|||||TWO_SIDED|95.0|-4.8|10.7|||||Placebo-Propranolol|||10.7|-4.8|
72602579|NCT02585713|144734801|SUPERIORITY|||||||0.1316|||||||Log Rank|||||||0.1316
72602580|NCT03173456|144734803|SUPERIORITY|||||||0.69||||||A priori threshold for statistical significance was 0.05. The plan was to only do individual comparisons between means if the overall test of the analysis of variance (AVOVA) was statistically significant|ANOVA|||The null hypothesis is that all means are equal. The alternate hypothesis is that one or more mean is less than or more than another.||||0.69
72602581|NCT03173456|144734804|SUPERIORITY|||||||0.85||||||Threshold for statistical significance was 0.05. The plan was to only compare means if the overall test of AVOVA was statistically significant.|ANOVA|||||||0.85
72602582|NCT03173456|144734805|SUPERIORITY|||||||0.99||||||Threshold for statistical significance = 0.05|Chi-squared|||||||0.99
72602583|NCT03173456|144734807|SUPERIORITY|||||||0.46|||||||Chi-squared|||||||0.46
72602584|NCT03173456|144734808|SUPERIORITY|||||||0.0501||||||0.05 was the a priori threshold for statistical significance|Chi-squared|||||||0.0501
72602585|NCT01733121|144734809|OTHER||Mean Difference (Final Values)|-3.0|STANDARD_ERROR_OF_MEAN|0.7|<|0.0001|TWO_SIDED|95.0|-4.5|-1.6|||ANCOVA|||||-1.6|-4.5|<.0001
72602586|NCT01733121|144734810|OTHER||Mean Difference (Final Values)|-0.8|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001|TWO_SIDED|95.0|-1.2|-0.4|||ANOVA|||||-0.4|-1.2|<0.0001
72602587|NCT01733121|144734811|OTHER||Mean Difference (Final Values)|-2.4|STANDARD_ERROR_OF_MEAN|0.7||0.0005|TWO_SIDED|95.0|-3.7|-1.1|||ANCOVA|||||-1.1|-3.7|0.0005
72602588|NCT01733121|144734812|OTHER||Mean Difference (Final Values)|-0.8|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001|TWO_SIDED|95.0|-1.2|-0.5|||ANOVA|||||-0.5|-1.2|<.0001
72602589|NCT04501952|144734822|SUPERIORITY||Hazard Ratio (HR)|0.134||||0.0076|TWO_SIDED|95.0|0.031|0.586|||Regression, Cox|P-value was estimated using the Cox regression with baseline stratification factors as covariates.|Hazard ratio and two-sided 95% confidence interval (CI) were estimated using the Cox regression with baseline stratification factors as covariates.|||0.586|0.031|0.0076
72602590|NCT04501952|144734824|SUPERIORITY||Hazard Ratio (HR)|0.191||||0.0024|TWO_SIDED|95.0|0.065|0.555|||Regression, Cox|P-value was estimated using the Cox regression with baseline stratification factors as covariates.|Hazard ratio and two-sided 95% CI were estimated using the Cox regression with baseline stratification factors as covariates.|||0.555|0.065|0.0024
72602591|NCT04501952|144734827|SUPERIORITY||Hazard Ratio (HR)|0.134||||0.0076|TWO_SIDED|95.0|0.031|0.586|||Regression, Cox|P-value were estimated using the Cox regression with baseline stratification factors as covariates.|Hazard ratio and two-sided 95% CI were estimated using the Cox regression with baseline stratification factors as covariates.|||0.586|0.031|0.0076
72602592|NCT04501952|144734828|SUPERIORITY||Hazard Ratio (HR)|0.1||||0.0019|TWO_SIDED|95.0|0.023|0.43|||Regression, Cox|P-value were estimated using the Cox regression with baseline stratification factors as covariates.|Hazard ratio and two-sided 95% CI were estimated using the Cox regression with baseline stratification factors as covariates.|||0.430|0.023|0.0019
72602593|NCT04501952|144734829|SUPERIORITY||Least Squares Mean|0.07|STANDARD_ERROR_OF_MEAN|0.09||0.4318|TWO_SIDED|95.0|-0.1|0.24|||ANCOVA|P-value were from an ANCOVA model with baseline viral load as a covariate.|Least squares Mean (LSM), standard error (SE) and 95% CI were from an ANCOVA model with baseline viral load as a covariate.|||0.24|-0.10|0.4318
72602594|NCT04501952|144734830|SUPERIORITY||Hazard Ratio (HR)|1.405||||0.2987|TWO_SIDED|95.0|0.733|2.693|||Log Rank|p-value was based on stratified log-rank test with baseline stratification factor as strata.|Hazard ratio and two-sided 95% CI were estimated using the Cox regression with baseline stratification factors as covariates.|||2.693|0.733|0.2987
72602595|NCT04501952|144734832|SUPERIORITY|||||||0.2163|||||||Fisher Exact|||||||0.2163
72602596|NCT00436826|144734863|SUPERIORITY||Relative Risk|0.37|||<|0.001|TWO_SIDED|95.0|0.22|0.63|||Wald Chi-square|||||0.63|0.22|<0.001
72602597|NCT00784719|144734883|SUPERIORITY_OR_OTHER||Median|59.0|||||TWO_SIDED|80.0|57.0||Upper limit of 80% CI was not estimable as there were insufficient number of participants, who achieved \>=10 mm Schirmer test score in this reporting group, for the analysis.||||||||57.0|
72602598|NCT00784719|144734883|SUPERIORITY_OR_OTHER||Median|58.0|||||TWO_SIDED|80.0|58.0||Upper limit of 80% CI was not estimable as there were insufficient number of participants, who achieved \>=10 mm Schirmer test score in this reporting group, for the analysis.||||||||58.0|
72602599|NCT00784719|144734883|SUPERIORITY_OR_OTHER||Median|57.0|||||TWO_SIDED|80.0|29.0||Upper limit of 80% CI was not estimable as there were insufficient number of participants, who achieved \>=10 mm Schirmer test score in this reporting group, for the analysis.||||||||29.0|
72602600|NCT00784719|144734885|SUPERIORITY_OR_OTHER||Median|15.0|||||TWO_SIDED|80.0|9.0|28.0||||||||28.0|9.0|
72602601|NCT00784719|144734885|SUPERIORITY_OR_OTHER||Median|8.5|||||TWO_SIDED|80.0|8.0|27.0||||||||27.0|8.0|
72602602|NCT00784719|144734885|SUPERIORITY_OR_OTHER||Median|15.0|||||TWO_SIDED|80.0|15.0|27.0||||||||27.0|15.0|
72602603|NCT00784719|144734885|SUPERIORITY_OR_OTHER||Median|9.5|||||TWO_SIDED|80.0|8.0|15.0||||||||15.0|8.0|
72602604|NCT00784719|144734885|SUPERIORITY_OR_OTHER||Median|9.0|||||TWO_SIDED|80.0|8.0|15.0||||||||15.0|8.0|
72602605|NCT00784719|144734885|SUPERIORITY_OR_OTHER||Median|15.0|||||TWO_SIDED|80.0|8.0|43.0||||||||43.0|8.0|
72602606|NCT00784719|144734885|SUPERIORITY_OR_OTHER||Median|16.0|||||TWO_SIDED|80.0|15.0|30.0||||||||30.0|15.0|
72602607|NCT05464420|144734916|OTHER|Estimated difference in percentage and 95% confidence intervals (CI) were based on the Miettinen \& Nurminen method.|Estimated difference in percentage|6.0|||||TWO_SIDED|95.0|3.0|8.6||||||Injection site erythema: V116 Combined Lots - PPSV23||8.6|3.0|
72602608|NCT05464420|144734916|OTHER|Estimated difference in percentage and 95% CI were based on the Miettinen \& Nurminen method.|Estimated difference in percentage|12.6|||||TWO_SIDED|95.0|8.0|17.3||||||Injection site pain: V116 Combined Lots - PPSV23||17.3|8.0|
72602609|NCT05464420|144734916|OTHER|Estimated difference in percentage and 95% CI were based on the Miettinen \& Nurminen method.|Estimated difference in percentage|5.6|||||TWO_SIDED|95.0|2.6|8.2||||||Injection site swelling: V116 Combined Lots - PPSV23||8.2|2.6|
72602610|NCT05464420|144734918|OTHER|Estimated difference in percentage and 95% CI were based on the Miettinen \& Nurminen method.|Estimated difference in percentage|1.4|||||TWO_SIDED|95.0|-3.2|6.0||||||Fatigue: V116 Combined Lots - PPSV23||6.0|-3.2|
72602611|NCT05464420|144734918|OTHER|Estimated difference in percentage and 95% CI were based on the Miettinen \& Nurminen method.|Estimated difference in percentage|5.8|||||TWO_SIDED|95.0|1.6|9.7||||||Headache: V116 Combined Lots - PPSV23||9.7|1.6|
72602612|NCT05464420|144734918|OTHER|Estimated difference in percentage and 95% CI were based on the Miettinen \& Nurminen method.|Estimated difference in percentage|7.6|||||TWO_SIDED|95.0|4.5|10.5||||||Myalgia: V116 Combined Lots - PPSV23||10.5|4.5|
72602613|NCT05464420|144734918|OTHER|Estimated difference in percentage and 95% CI were based on the Miettinen \& Nurminen method.|Estimated difference in percentage|0.8|||||TWO_SIDED|95.0|-1.0|2.1||||||Pyrexia: V116 Combined Lots - PPSV23||2.1|-1.0|
72602614|NCT05464420|144734920|OTHER|Estimated difference in percentage and 95% CI were based on the Miettinen \& Nurminen method.|Estimated difference in percentage|0.0|||||TWO_SIDED|95.0|-0.7|0.2||||||Vaccine-related SAEs: V116 Combined Lots - PPSV23||0.2|-0.7|
72602615|NCT05464420|144734921|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|1.09|||<|0.001|TWO_SIDED|95.0|0.96|1.24||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 1/V116 Lot 2|Serotype 3: GMT Ratio V116 Lot 1/ V116 Lot 2||1.24|0.96|<0.001
72602616|NCT05464420|144734921|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|1.03|||<|0.001|TWO_SIDED|95.0|0.9|1.17||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 1/ V116 Lot 3|Serotype 3: GMT Ratio V116 Lot 1/ V116 Lot 3||1.17|0.90|<0.001
72602617|NCT05464420|144734921|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|0.94|||<|0.001|TWO_SIDED|95.0|0.83|1.06||Identical p-values for the lower and upper bounds.|cLDA Model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 2/ V116 Lot 3|Serotype 3: GMT Ratio V116 Lot 2/ V116 Lot 3||1.06|0.83|<0.001
72602618|NCT05464420|144734921|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|1.15|||<|0.001|TWO_SIDED|95.0|0.97|1.35||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 1/V116 Lot 2|Serotype 6A: GMT Ratio V116 Lot 1/ V116 Lot 2||1.35|0.97|<0.001
72602619|NCT05464420|144734921|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|1.04|||<|0.001|TWO_SIDED|95.0|0.88|1.22||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 1/V116 Lot 3|Serotype 6A: GMT Ratio V116 Lot 1/ V116 Lot 3||1.22|0.88|<0.001
72602620|NCT05464420|144734921|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|0.91|||<|0.001|TWO_SIDED|95.0|0.77|1.06||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 2/V116 Lot 3|Serotype 6A: GMT Ratio V116 Lot 2/ V116 Lot 3||1.06|0.77|<0.001
72602621|NCT05464420|144734921|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|1.16|||<|0.001|TWO_SIDED|95.0|1.01|1.34||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 1/V116 Lot 2|Serotype 7F: V116 Lot 1/ V116 Lot 2||1.34|1.01|<0.001
72602622|NCT05464420|144734921|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|1.08|||<|0.001|TWO_SIDED|95.0|0.94|1.25||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 1/V116 Lot 3|Serotype 7F: GMT Ratio V116 Lot 1/ V116 Lot 3||1.25|0.94|<0.001
72602623|NCT05464420|144734921|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|0.93|||<|0.001|TWO_SIDED|95.0|0.81|1.07||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 2/V116 Lot 3|Serotype 7F: GMT Ratio V116 Lot 2/ V116 Lot 3||1.07|0.81|<0.001
72602624|NCT05464420|144734921|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|1.03|||<|0.001|TWO_SIDED|95.0|0.92|1.16||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 1/V116 Lot 2|Serotype 8 V116 Lot 1/V116 Lot 2||1.16|0.92|<0.001
72416238|NCT01972841|144343300|SUPERIORITY||least squares mean difference|-1.64|STANDARD_ERROR_OF_MEAN|0.83||0.074|TWO_SIDED|95.0|-3.27|-0.01|||Stratified rank ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the solifenacin 5 mg monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.offset variable.||-0.01|-3.27|0.074
72552543|NCT01049334|144635898|SUPERIORITY_OR_OTHER||least-square means difference|-156.3||||0.0435|TWO_SIDED|95.0|-307.9|-4.6||The a priori threshold for statistical significance is 0.05. Closed-sequential approach to control type I error: analyses through secondary outcomes #2-13 in the order listed will proceed until a p-value \>0.05 occurs.|ANOVA|||||-4.6|-307.9|0.0435
72602625|NCT05464420|144734921|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|1.05|||<|0.001|TWO_SIDED|95.0|0.93|1.18||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 1/ V116 Lot 3|Serotype 8: GMT Ratio V116 Lot 1/ V116 Lot 3||1.18|0.93|<0.001
72602626|NCT05464420|144734921|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|1.01|||<|0.001|TWO_SIDED|95.0|0.9|1.14||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 2/ V116 Lot 3|Serotype 8: GMT Ratio V116 Lot 2/ V116 Lot 3||1.14|0.90|<0.001
72602627|NCT05464420|144734921|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|1.09|||<|0.001|TWO_SIDED|95.0|0.94|1.26||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 1/V116 Lot 2|Serotype 9N: GMT Ratio V116 Lot 1/ V116 Lot 2||1.26|0.94|<0.001
72602628|NCT05464420|144734921|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|1.01|||<|0.001|TWO_SIDED|95.0|0.87|1.17||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 1/V116 Lot 3|Serotype 9N: GMT Ratio V116 Lot 1/ V116 Lot 3||1.17|0.87|<0.001
72602629|NCT05464420|144734921|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|0.93|||<|0.001|TWO_SIDED|95.0|0.8|1.07||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 2/V116 Lot 3|Serotype 9N: GMT Ratio V116 Lot 2/V116 Lot 3||1.07|0.80|<0.001
72602630|NCT05464420|144734921|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|0.97|||<|0.001|TWO_SIDED|95.0|0.85|1.11||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 1/V116 Lot 2|Serotype 10A: GMT Ratio V116 Lot 1/ V116 Lot 2||1.11|0.85|<0.001
72602631|NCT05464420|144734921|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|1.03|||<|0.001|TWO_SIDED|95.0|0.91|1.18||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 1/V116 Lot 3|Serotype 10A: GMT Ratio V116 Lot 1/ V116 Lot 3||1.18|0.91|<0.001
72602632|NCT05464420|144734921|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|1.06|||<|0.001|TWO_SIDED|95.0|0.93|1.21||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 2/V116 Lot 3|Serotype 10A: GMT Ratio V116 Lot 2/V116 Lot 3||1.21|0.93|<0.001
72602633|NCT05464420|144734921|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|0.96|||<|0.001|TWO_SIDED|95.0|0.84|1.11||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 1/V116 Lot 2|Serotype 11A: GMT Ratio V116 Lot 1/ V116 Lot 2||1.11|0.84|<0.001
72602634|NCT05464420|144734921|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|1.0|||<|0.001|TWO_SIDED|95.0|0.87|1.16||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 1/V116 Lot 3|Serotype 11A: GMT Ratio V116 Lot 1/V116 Lot 3||1.16|0.87|<0.001
72602635|NCT05464420|144734921|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|1.04|||<|0.001|TWO_SIDED|95.0|0.9|1.2||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 2/V116 Lot 3|Serotype 11A: GMT Ratio V116 Lot 2/V116 Lot 3||1.20|0.90|<0.001
72602636|NCT05464420|144734921|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|1.1|||<|0.001|TWO_SIDED|95.0|0.96|1.26||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 1/V116 Lot 2|Serotype 12F: GMT Ratio V116 Lot 1/V116 Lot 2||1.26|0.96|<0.001
72602637|NCT05464420|144734921|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|1.02|||<|0.001|TWO_SIDED|95.0|0.89|1.17||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 1/V116 Lot 3|Serotype 12F: GMT Ratio V116 Lot 1/V116 Lot 3||1.17|0.89|<0.001
72602638|NCT05464420|144734921|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|0.93|||<|0.001|TWO_SIDED|95.0|0.81|1.07||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 2/V116 Lot 3|Serotype 12F: GMT Ratio V116 Lot 2/V116 Lot 3||1.07|0.81|<0.001
72602639|NCT05464420|144734921|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|1.04|||<|0.001|TWO_SIDED|95.0|0.89|1.22||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 1/V116 Lot 2|Serotype 15A: GMT Ratio V116 Lot 1/V116 Lot 2||1.22|0.89|<0.001
72602640|NCT05464420|144734921|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|1.0|||<|0.001|TWO_SIDED|95.0|0.86|1.17||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 1/V116 Lot 3|Serotype 15A: GMT Ratio V116 Lot 1/V116 Lot 3||1.17|0.86|<0.001
72602641|NCT05464420|144734921|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|0.96|||<|0.001|TWO_SIDED|95.0|0.82|1.12||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 2/V116 Lot 3|Serotype 15A: GMT Ratio V116 Lot 2/V116 Lot 3||1.12|0.82|<0.001
72602642|NCT05464420|144734921|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|1.15|||<|0.001|TWO_SIDED|95.0|0.95|1.38||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 1/V116 Lot 2|Serotype 15C: GMT Ratio V116 Lot 1/V116 Lot 2||1.38|0.95|<0.001
72602643|NCT05464420|144734921|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|1.18|||<|0.001|TWO_SIDED|95.0|0.97|1.42||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 1/V116 Lot 3|Serotype 15C: GMT Ratio V116 Lot 1/V116 Lot 3||1.42|0.97|<0.001
72602644|NCT05464420|144734921|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|1.02|||<|0.001|TWO_SIDED|95.0|0.85|1.23||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 2/V116 Lot 3|Serotype 15C: GMT Ratio V116 Lot 2/V116 Lot 3||1.23|0.85|<0.001
72416239|NCT01972841|144343300|SUPERIORITY||Least squares mean difference|-1.33|STANDARD_ERROR_OF_MEAN|0.83||0.025|TWO_SIDED|95.0|-2.96|0.3|||Stratified rank ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the solifenacin 5 mg monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||0.30|-2.96|0.025
72552544|NCT01049334|144635899|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|95.0||||The a priori threshold for statistical significance is 0.05. Closed-sequential approach to control type I error: analyses through secondary outcomes #2-13 in the order listed will proceed until a p-value \>0.05 occurs.|Wilcoxon (Mann-Whitney)|||||||<.0001
72552545|NCT01049334|144635900|SUPERIORITY_OR_OTHER||least-square means difference|0.1||||0.1448|TWO_SIDED|95.0|0.0|0.1|||ANOVA|Baseline STPIS fitted as a covariate||Minutes post dose: 2||0.1|-0.0|0.1448
72552546|NCT01049334|144635900|SUPERIORITY_OR_OTHER||least-square means difference|0.1||||0.1538|TWO_SIDED|95.0|0.0|0.3|||ANOVA|Baseline STPIS fitted as a covariate||Minutes post dose: 4||0.3|-0.0|0.1538
72552547|NCT01049334|144635900|SUPERIORITY_OR_OTHER||least-square means difference|0.2||||0.1407|TWO_SIDED|95.0|-0.1|0.5|||ANOVA|Baseline STPIS fitted as a covariate||Minutes post dose: 6||0.5|-0.1|0.1407
72552548|NCT01049334|144635900|SUPERIORITY_OR_OTHER||least-square means difference|0.2||||0.2906|TWO_SIDED|95.0|-0.2|0.7|||ANOVA|Baseline STPIS fitted as a covariate||Minutes post dose: 8||0.7|-0.2|0.2906
72552549|NCT01049334|144635900|SUPERIORITY_OR_OTHER||least-square means difference|0.2||||0.4758|TWO_SIDED|95.0|-0.4|0.8|||ANOVA|Baseline STPIS fitted as a covariate||Minutes post dose: 10||0.8|-0.4|0.4758
72552550|NCT01049334|144635900|SUPERIORITY_OR_OTHER||least-square means difference|0.1||||0.6975|TWO_SIDED|95.0|-0.6|0.9|||ANOVA|Baseline STPIS fitted as a covariate||Minutes post dose: 12||0.9|-0.6|0.6975
72552551|NCT01049334|144635900|SUPERIORITY_OR_OTHER||least-square means difference|0.0||||0.937|TWO_SIDED|95.0|-0.8|0.9|||ANOVA|Baseline STPIS fitted as a covariate||Minutes post dose: 14||0.9|-0.8|0.9370
72552552|NCT01049334|144635900|SUPERIORITY_OR_OTHER||least-square means difference|-0.1||||0.8493|TWO_SIDED|95.0|-1.1|0.9|||ANOVA|Baseline STPIS fitted as a covariate||Minutes post dose: 16||0.9|-1.1|0.8493
72552553|NCT01049334|144635900|SUPERIORITY_OR_OTHER||least-square means difference|-0.3||||0.6732|TWO_SIDED|95.0|-1.4|0.9|||ANOVA|Baseline STPIS fitted as a covariate||Minutes post dose: 18||0.9|-1.4|0.6732
72552554|NCT01049334|144635900|SUPERIORITY_OR_OTHER||least-square means difference|-0.4||||0.5414|TWO_SIDED|95.0|-1.8|0.9|||ANOVA|Baseline STPIS fitted as a covariate||Minutes post dose: 20||0.9|-1.8|0.5414
72552555|NCT01049334|144635900|SUPERIORITY_OR_OTHER||least-square means difference|-0.6||||0.4313|TWO_SIDED|95.0|-2.1|0.9|||ANOVA|Baseline STPIS fitted as a covariate||Minutes post dose: 22||0.9|-2.1|0.4313
72552556|NCT01049334|144635900|SUPERIORITY_OR_OTHER||least-square means difference|-0.8||||0.3501|TWO_SIDED|95.0|-2.4|0.9|||ANOVA|Baseline STPIS fitted as a covariate||Minutes post dose: 24||0.9|-2.4|0.3501
72552557|NCT01049334|144635900|SUPERIORITY_OR_OTHER||least-square means difference|-1.0||||0.2679|TWO_SIDED|95.0|-2.8|0.8|||ANOVA|Baseline STPIS fitted as a covariate||Minutes post dose: 26||0.8|-2.8|0.2679
72552558|NCT01049334|144635900|SUPERIORITY_OR_OTHER||least-square means difference|-1.2||||0.2137|TWO_SIDED|95.0|-3.2|0.7|||ANOVA|Baseline STPIS fitted as a covariate||Minutes post dose: 28||0.7|-3.2|0.2137
72552559|NCT01049334|144635900|SUPERIORITY_OR_OTHER||least-square means difference|-1.5||||0.1715|TWO_SIDED|95.0|-3.6|0.6|||ANOVA|Baseline STPIS fitted as a covariate||Minutes post dose: 30||0.6|-3.6|0.1715
72552560|NCT01049334|144635900|SUPERIORITY_OR_OTHER||least-square means difference|-1.8||||0.134|TWO_SIDED|95.0|-4.1|0.5|||ANOVA|Baseline STPIS fitted as a covariate||Minutes post dose: 32||0.5|-4.1|0.1340
72552561|NCT01049334|144635900|SUPERIORITY_OR_OTHER||least-square means difference|-2.0||||0.103|TWO_SIDED|95.0|-4.5|0.4|||ANOVA|Baseline STPIS fitted as a covariate||Minutes post dose: 34||0.4|-4.5|0.1030
72552562|NCT01049334|144635900|SUPERIORITY_OR_OTHER||least-square means difference|-2.4||||0.0788|TWO_SIDED|95.0|-5.0|0.3|||ANOVA|Baseline STPIS fitted as a covariate||Minutes post dose: 36||0.3|-5.0|0.0788
72552563|NCT01049334|144635900|SUPERIORITY_OR_OTHER||least-square means difference|-2.7||||0.062|TWO_SIDED|95.0|-5.5|0.1|||ANOVA|Baseline STPIS fitted as a covariate||Minutes post dose: 38||0.1|-5.5|0.0620
72552564|NCT01049334|144635900|SUPERIORITY_OR_OTHER||least-square means difference|-3.0||||0.0476|TWO_SIDED|95.0|-6.0|0.0|||ANOVA|Baseline STPIS fitted as a covariate||Minutes post dose: 40||-0.0|-6.0|0.0476
72552565|NCT01049334|144635901|SUPERIORITY_OR_OTHER|||||||0.0273||95.0|||||Log Rank|||||||0.0273
72552566|NCT01049334|144635902|SUPERIORITY_OR_OTHER|||||||0.0098||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0098
72552567|NCT03979079|144635905|OTHER||Hazard Ratio (HR)|0.21|||||TWO_SIDED|95.0|0.14|0.3||Estimation was performed using a Bayesian approach. As such, p-values are not estimated.|Two-stage model.||||Two-stage model within a Bayesian framework to assess the role of the prostate-specific antigens profile on clinical failure while accounting for a secondary treatment prescribed by indication. Prostatespecific antigens modeled using a hierarchical piecewise linear trajectory with a random changepoint. Residual prostate-specific antigens variability was expressed as a function of prostate-specific antigens concentration. Covariates in the survival model included hormone therapy, baseline characteristics, and individual predictions of the prostate-specific antigens nadir and timing and prostate-specific antigens slopes before and after the nadir as provided by the longitudinal process.|0.30|0.14|
72552568|NCT00667095|144635938|SUPERIORITY_OR_OTHER|||||||0.024|||||||t-test, 2 sided|||Change from baseline to 1 month.||||0.024
72552569|NCT00667095|144635938|SUPERIORITY_OR_OTHER|||||||0.036|||||||t-test, 2 sided|||Change from baseline to 3 months.||||0.036
72552570|NCT00667095|144635939|SUPERIORITY_OR_OTHER|||||||0.051|||||||t-test, 2 sided|||Change from baseline to 1 month.||||0.051
72552571|NCT00667095|144635939|SUPERIORITY_OR_OTHER|||||||0.12|||||||t-test, 2 sided|||Change from baseline to 3 months.||||0.12
72552572|NCT00667095|144635940|SUPERIORITY_OR_OTHER|||||||0.42|||||||t-test, 2 sided|||Change from baseline to 1 month.||||0.42
72552573|NCT00667095|144635940|SUPERIORITY_OR_OTHER|||||||0.15|||||||t-test, 2 sided|||Change from baseline to 3 months.||||0.15
72552574|NCT00667095|144635941|SUPERIORITY_OR_OTHER|||||||0.18|||||||t-test, 2 sided|||Change from baseline to 1 month||||0.18
72552575|NCT00667095|144635941|SUPERIORITY_OR_OTHER|||||||0.77|||||||t-test, 2 sided|||Change from baseline to 3 months.||||0.77
72552576|NCT00667095|144635942|SUPERIORITY_OR_OTHER|||||||0.67|||||||t-test, 2 sided|||Change from baseline to one month||||0.67
72552577|NCT00667095|144635942|SUPERIORITY_OR_OTHER|||||||0.2|||||||t-test, 2 sided|||Change from baseline to 3 months.||||0.20
72552578|NCT00667095|144635943|SUPERIORITY_OR_OTHER|||||||0.31|||||||t-test, 2 sided|||Change between baseline and one month||||0.31
72552579|NCT00667095|144635943|SUPERIORITY_OR_OTHER|||||||0.038|||||||t-test, 2 sided|||Change between baseline and 3 months||||0.038
72552580|NCT01832259|144635966|SUPERIORITY|||||||0.345|||||||t-test, 1 sided|||||||0.345
72552581|NCT01832259|144635968|SUPERIORITY|||||||0.46|||||||Log Rank|||||||0.46
72552582|NCT00909610|144635987|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of Variance (ANOVA) will be applied to log-transformed AUC's and Cmax parameters.|Geometric Test/Ref Ratio x 100|101.0||||||90.0|92.3|111.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125|||111|92.3|
72552583|NCT00909610|144635988|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of Variance (ANOVA) will be applied to log-transformed AUC's and Cmax parameters.|Ratio of the Geometric Mean|106.0||||||90.0|101.0|112.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||112|101|
72552584|NCT00909610|144635989|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of Variance (ANOVA) will be applied to log-transformed AUC's and Cmax parameters.|Ratio of the Geometric Mean|101.0||||||90.0|91.9|111.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||111|91.9|
72602645|NCT05464420|144734921|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|0.97|||<|0.001|TWO_SIDED|95.0|0.84|1.11||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 1/V116 Lot 2|Serotype 16F: GMT Ratio V116 Lot 1/V116 Lot 2||1.11|0.84|<0.001
72602646|NCT05464420|144734921|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|0.97|||<|0.001|TWO_SIDED|95.0|0.84|1.11||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 1/V116 Lot 3|Serotype 16F: GMT Ratio V116 Lot 1/V116 Lot 3||1.11|0.84|<0.001
72602647|NCT05464420|144734921|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|1.0|||<|0.001|TWO_SIDED|95.0|0.87|1.15||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 2/V116 Lot 3|Serotype 16F: GMT Ratio V116 Lot 2/V116 Lot 3||1.15|0.87|<0.001
72602648|NCT05464420|144734921|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|0.97|||<|0.001|TWO_SIDED|95.0|0.85|1.11||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 1/V116 Lot 2|Serotype 17F: GMT Ratio V116 Lot 1/V116 Lot 2||1.11|0.85|<0.001
72602649|NCT05464420|144734921|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|1.02|||<|0.001|TWO_SIDED|95.0|0.89|1.17||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 1/V116 Lot 3|Serotype 17F: GMT Ratio V116 Lot 1/V116 Lot 3||1.17|0.89|<0.001
72602650|NCT05464420|144734921|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|1.05|||<|0.001|TWO_SIDED|95.0|0.92|1.2||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 2/V116 Lot 3|Serotype 17F: GMT Ratio V116 Lot 2/V116 Lot 3||1.20|0.92|<0.001
72602651|NCT05464420|144734921|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|1.02|||<|0.001|TWO_SIDED|95.0|0.91|1.15||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 1/V116 Lot 2|Serotype 19A: GMT Ratio V116 Lot 1/V116 Lot 2||1.15|0.91|<0.001
72602652|NCT05464420|144734921|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|0.95|||<|0.001|TWO_SIDED|95.0|0.84|1.07||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 1/V116 Lot 3|Serotype 19A: GMT Ratio V116 Lot 1/V116 Lot 3||1.07|0.84|<0.001
72602653|NCT05464420|144734921|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|0.93|||<|0.001|TWO_SIDED|95.0|0.82|1.04||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 2/V116 Lot 3|Serotype 19A: GMT Ratio V116 Lot 2/V116 Lot 3||1.04|0.82|<0.001
72602654|NCT05464420|144734921|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|0.98|||<|0.001|TWO_SIDED|95.0|0.84|1.14||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 1/V116 Lot 2|Serotype 20A: GMT Ratio V116 Lot 1/V116 Lot 2||1.14|0.84|<0.001
72602655|NCT05464420|144734921|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|1.07|||<|0.001|TWO_SIDED|95.0|0.92|1.24||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 1/V116 Lot 3|Serotype 20A: GMT Ratio V116 Lot 1/V116 Lot 3||1.24|0.92|<0.001
72602656|NCT05464420|144734921|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|1.09|||<|0.001|TWO_SIDED|95.0|0.94|1.27||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 2/V116 Lot 3|Serotype 20A: GMT Ratio V116 Lot 2/V116 Lot 3||1.27|0.94|<0.001
72602657|NCT05464420|144734921|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|1.1|||<|0.001|TWO_SIDED|95.0|0.93|1.29||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 1/V116 Lot 2|Serotype 22F: GMT Ratio V116 Lot 1/V116 Lot 2||1.29|0.93|<0.001
72602658|NCT05464420|144734921|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|1.03|||<|0.001|TWO_SIDED|95.0|0.87|1.21||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 1/V116 Lot 3|Serotype 22F: GMT Ratio V116 Lot 1/V116 Lot 3||1.21|0.87|<0.001
72602659|NCT05464420|144734921|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|0.94|||<|0.001|TWO_SIDED|95.0|0.8|1.1||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 2/V116 Lot 3|Serotype 22F: GMT Ratio V116 Lot 2/V116 Lot 3||1.10|0.80|<0.001
72602660|NCT05464420|144734921|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|1.0|||<|0.001|TWO_SIDED|95.0|0.85|1.17||Identical p-values for the lower and upper bounds.|cDLA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 1/V116 Lot 2|Serotype 23A: GMT Ratio V116 Lot 1/V116 Lot 2||1.17|0.85|<0.001
72602661|NCT05464420|144734921|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|1.01|||<|0.001|TWO_SIDED|95.0|0.86|1.19||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 1/V116 Lot 3|Serotype 23A: GMT Ratio V116 Lot 1/V116 Lot 3||1.19|0.86|<0.001
72602662|NCT05464420|144734921|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|1.02|||<|0.001|TWO_SIDED|95.0|0.87|1.19||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 2/V116 Lot 3|Serotype 23A: GMT Ratio V116 Lot 2/V116 Lot 3||1.19|0.87|<0.001
72602663|NCT05464420|144734921|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|1.22|||<|0.001|TWO_SIDED|95.0|1.0|1.48||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 1/V116 Lot 2|Serotype 23B: GMT Ratio V116 Lot 1/V116 Lot 2||1.48|1.00|<0.001
72602664|NCT05464420|144734921|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|0.98|||<|0.001|TWO_SIDED|95.0|0.8|1.19||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 1/V116 Lot 3|Serotype 23B: GMT Ratio V116 Lot 1/V116 Lot 3||1.19|0.80|<0.001
72602665|NCT05464420|144734921|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|0.8|||<|0.001|TWO_SIDED|95.0|0.66|0.97||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 2/V116 Lot 3|Serotype 23B: GMT Ratio V116 Lot 2/V116 Lot 3||0.97|0.66|<0.001
72602666|NCT05464420|144734921|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|1.02|||<|0.001|TWO_SIDED|95.0|0.88|1.18||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 1/V116 Lot 2|Serotype 24F: GMT Ratio V116 Lot 1/V116 Lot 2||1.18|0.88|<0.001
72602667|NCT05464420|144734921|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|1.02|||<|0.001|TWO_SIDED|95.0|0.88|1.18||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 1/V116 Lot 3|Serotype 24F: GMT Ratio V116 Lot 1/V116 Lot 3||1.18|0.88|<0.001
72602668|NCT05464420|144734921|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|1.01|||<|0.001|TWO_SIDED|95.0|0.87|1.16||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 2/V116 Lot 3|Serotype 24F: GMT Ratio V116 Lot 2/V116 Lot 3||1.16|0.87|<0.001
72602669|NCT05464420|144734921|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|1.02|||<|0.001|TWO_SIDED|95.0|0.87|1.2||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 1/V116 Lot 2|Serotype 31: GMT Ratio V116 Lot 1/V116 Lot 2||1.20|0.87|<0.001
72602670|NCT05464420|144734921|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|1.02|||<|0.001|TWO_SIDED|95.0|0.87|1.2||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 1/V116 Lot 3|Serotype 31: GMT Ratio V116 Lot 1/V116 Lot 3||1.20|0.87|<0.001
72602671|NCT05464420|144734921|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|1.0|||<|0.001|TWO_SIDED|95.0|0.85|1.17||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 2/V116 Lot 3|Serotype 31: GMT Ratio V116 Lot 2/V116 Lot 3||1.17|0.85|<0.001
72602672|NCT05464420|144734921|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|1.11|||<|0.001|TWO_SIDED|95.0|0.93|1.33||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 1/V116 Lot 2|Serotype 33F: GMT Ratio V116 Lot 1/V116 Lot 2||1.33|0.93|<0.001
72602673|NCT05464420|144734921|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|1.08|||<|0.001|TWO_SIDED|95.0|0.9|1.29||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 1/V116 Lot 3|Serotype 33F: GMT Ratio V116 Lot 1/V116 Lot 3||1.29|0.90|<0.001
72602674|NCT05464420|144734921|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|0.97|||<|0.001|TWO_SIDED|95.0|0.81|1.16||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 2/V116 Lot 3|Serotype 33F: GMT Ratio V116 Lot 2/V116 Lot 3||1.16|0.81|<0.001
72602675|NCT05464420|144734921|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|1.03|||<|0.001|TWO_SIDED|95.0|0.91|1.17||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 1/V116 Lot 2|Serotype 35B: GMT Ratio V116 Lot 1/V116 Lot 2||1.17|0.91|<0.001
72602676|NCT05464420|144734921|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|1.04|||<|0.001|TWO_SIDED|95.0|0.91|1.18||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 1/V116 Lot 3|Serotype 35B: GMT Ratio V116 Lot 1/V116 Lot 3||1.18|0.91|<0.001
72602677|NCT05464420|144734921|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|1.01|||<|0.001|TWO_SIDED|95.0|0.89|1.14||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 2/V116 Lot 3|Serotype 35B: GMT Ratio V116 Lot 2/V116 Lot 3||1.14|0.89|<0.001
72602678|NCT05464420|144734922|OTHER||GMT Ratio|0.93|||||TWO_SIDED|95.0|0.84|1.03|||||V116 Combined Lots/PPSV23|Serotype 3: GMT Ratio V116 Combined Lots/ PPSV23|GMT Ratio and 95% CI were estimated from a cLDA model.|1.03|0.84|
72602679|NCT05464420|144734922|OTHER||GMT Ratio|3.48|||||TWO_SIDED|95.0|3.01|4.02|||||V116 Combined Lots/PPSV23|Serotype 6A: GMT Ratio V116 Combined Lots/ PPSV23|GMT Ratio and 95% CI were estimated from a cLDA model.|4.02|3.01|
72602680|NCT05464420|144734922|OTHER||GMT Ratio|1.33|||||TWO_SIDED|95.0|1.18|1.49|||||V116 Combined Lots/PPSV23|Serotype 7F: GMT Ratio V116 Combined Lots / PPSV23|GMT Ratio and 95% CI were estimated from a cLDA model.|1.49|1.18|
72602681|NCT05464420|144734922|OTHER||GMT Ratio|0.85|||||TWO_SIDED|95.0|0.77|0.93|||||V116 Combined Lots/PPSV23|Serotype 8: GMT Ratio V116 Combined Lots / PPSV23|GMT Ratio and 95% CI were estimated from a cLDA model.|0.93|0.77|
72602682|NCT05464420|144734922|OTHER||GMT Ratio|0.95|||||TWO_SIDED|95.0|0.85|1.08|||||V116 Combined Lots/PPSV23|Serotype 9N: GMT Ratio V116 Combined Lots / PPSV23|GMT Ratio and 95% CI were estimated from a cLDA model.|1.08|0.85|
72602683|NCT05464420|144734922|OTHER||GMT Ratio|1.32|||||TWO_SIDED|95.0|1.18|1.48|||||V116 Combined Lots/PPSV23|Serotype 10A: GMT Ratio V116 Combined Lots / PPSV23|GMT Ratio and 95% CI were estimated from a cLDA model.|1.48|1.18|
72602684|NCT05464420|144734922|OTHER||GMT Ratio|1.74|||||TWO_SIDED|95.0|1.56|1.95|||||V116 Combined Lots/PPSV23|Serotype 11A: GMT Ratio V116 Combined Lots / PPSV23|GMT Ratio and 95% CI were estimated from a cLDA model.|1.95|1.56|
72602685|NCT05464420|144734922|OTHER||GMT Ratio|1.38|||||TWO_SIDED|95.0|1.22|1.56|||||V116 Combined Lots/PPSV23|Serotype 12F: GMT Ratio V116 Combined Lots / PPSV23|GMT Ratio and 95% CI were estimated from a cLDA model.|1.56|1.22|
72602686|NCT05464420|144734922|OTHER||GMT Ratio|4.03|||||TWO_SIDED|95.0|3.56|4.56|||||V116 Combined Lots/PPSV23|Serotype 15A: GMT Ratio v116 Combined Lots / PPSV23|GMT Ratio and 95% CI were estimated from a cLDA model.|4.56|3.56|
72602687|NCT05464420|144734922|OTHER||GMT Ratio|2.9|||||TWO_SIDED|95.0|2.49|3.38|||||V116 Combined Lots/PPSV23|Serotype 15C: GMT Ratio V116 Combined Lots / PPSV23|GMT Ratio and 95% CI were estimated from a cLDA model.|3.38|2.49|
72602688|NCT05464420|144734922|OTHER||GMT Ratio|3.72|||||TWO_SIDED|95.0|3.32|4.17||||||Serotype 16F: GMT Ratio V116 Combined Lots / PPSV23|GMT Ratio and 95% CI were estimated from a cLDA model.|4.17|3.32|
72602689|NCT05464420|144734922|OTHER||GMT Ratio|1.71|||||TWO_SIDED|95.0|1.53|1.91|||||V116 Combined Lots/PPSV23|Serotype 17F: GMT Ratio V116 Combined Lots / PPSV23|GMT Ratio and 95% CI were estimated from a cLDA model.|1.91|1.53|
72602690|NCT05464420|144734922|OTHER||GMT Ratio|0.93|||||TWO_SIDED|95.0|0.84|1.03|||||V116 Combined Lots/PPSV23|Serotype 19A: GMT Ratio V116 Combined Lots / PPSV23|GMT Ratio and 95% CI were estimated from a cLDA model.|1.03|0.84|
72602691|NCT05464420|144734922|OTHER||GMT Ratio|1.47|||||TWO_SIDED|95.0|1.3|1.67|||||V116 Combined Lots/PPSV23|Serotype 20A: GMT Ratio V116 Combined Lots / PPSV23|GMT Ratio and 95% CI were estimated from a cLDA model.|1.67|1.30|
72602692|NCT05464420|144734922|OTHER||GMT Ratio|1.34|||||TWO_SIDED|95.0|1.17|1.53|||||V116 Combined Lots/PPSV23|Serotype 22F: GMT Ratio V116 Combined Lots / PPSV23|GMT Ratio and 95% CI were estimated from a cLDA model.|1.53|1.17|
72602693|NCT05464420|144734922|OTHER||GMT Ratio|7.98|||||TWO_SIDED|95.0|6.84|9.31|||||V116 Combined Lots/PPSV23|Serotype 23A: GMT Ratio V116 Combined Lots / PPSV23|GMT Ratio and 95% CI were estimated from a cLDA model.|9.31|6.84|
72602694|NCT05464420|144734922|OTHER||GMT Ratio|23.72|||||TWO_SIDED|95.0|19.71|28.55|||||V116 Combined Lots/PPSV23|Serotype 23B: GMT Ratio V116 Combined Lots / PPSV23|GMT Ratio and 95% CI were estimated from a cLDA model.|28.55|19.71|
72602695|NCT05464420|144734922|OTHER||GMT Ratio|19.55|||||TWO_SIDED|95.0|16.7|22.88|||||V116 Combined Lots/PPSV23|Serotype 24F: GMT Ratio V116 Combined Lots / PPSV23|GMT Ratio and 95% CI were estimated from a cLDA model.|22.88|16.70|
72602696|NCT05464420|144734922|OTHER||GMT Ratio|13.55|||||TWO_SIDED|95.0|11.68|15.71|||||V116 Combined Lots/PPSV23|Serotype 31: GMT Ratio V116 Combined Lots / PPSV23|GMT Ratio and 95% CI were estimated from a cLDA model.|15.71|11.68|
72602697|NCT05464420|144734922|OTHER||GMT Ratio|0.84|||||TWO_SIDED|95.0|0.73|0.97||||||Serotype 33F: GMT Ratio V116 Combined Lots / PPSV23|GMT Ratio and 95% CI were estimated from a cLDA model.|0.97|0.73|
72602698|NCT05464420|144734922|OTHER||GMT Ratio|3.71|||||TWO_SIDED|95.0|3.36|4.09|||||V116 Combined Lots/PPSV23|Serotype 35B: GMT Ratio V116 Combined Lots / PPSV23|GMT Ratio and 95% CI were estimated from a cLDA model.|4.09|3.36|
72602699|NCT05464420|144734923|OTHER||GMC Ratio|0.98|||||TWO_SIDED|95.0|0.88|1.09|||||V116 Lot 1/V116 Lot 2|Serotype 3: GMC Ratio V116 Lot 1/ V116 Lot 2|GMC Ratio and 95% CI were estimated from a cLDA model.|1.09|0.88|
72602700|NCT05464420|144734923|OTHER||GMC Ratio|0.95|||||TWO_SIDED|95.0|0.85|1.05|||||V116 Lot 1/V116 Lot 3|Serotype 3: GMC Ratio V116 Lot 1/ V116 Lot 3|GMC Ratio and 95% CI were estimated from a cLDA model.|1.05|0.85|
72602701|NCT05464420|144734923|OTHER||GMC Ratio|0.97|||||TWO_SIDED|95.0|0.87|1.08|||||V116 Lot 2/V116 Lot 3|Serotype 3: GMC Ratio V116 Lot 2/ V116 Lot 3|GMC Ratio and 95% CI were estimated from a cLDA model.|1.08|0.87|
72602702|NCT05464420|144734923|OTHER||GMC Ratio|1.12|||||TWO_SIDED|95.0|0.95|1.32|||||V116 Lot 1/V116 Lot 2|Serotype 6A: GMC Ratio V116 Lot 1/ V116 Lot 2|GMC Ratio and 95% CI were estimated from a cLDA model.|1.32|0.95|
72602703|NCT05464420|144734923|OTHER||GMC Ratio|1.02|||||TWO_SIDED|95.0|0.86|1.2|||||V116 Lot 1/V116 Lot 3|Serotype 6A: GMC Ratio V116 Lot 1/ V116 Lot 3|GMC Ratio and 95% CI were estimated from a cLDA model.|1.20|0.86|
72602704|NCT05464420|144734923|OTHER||GMC Ratio|0.91|||||TWO_SIDED|95.0|0.77|1.07|||||V116 Lot 2/V116 Lot 3|Serotype 6A: GMC Ratio V116 Lot 2/ V116 Lot 3|GMC Ratio and 95% CI were estimated from a cLDA model.|1.07|0.77|
72602705|NCT05464420|144734923|OTHER||GMC Ratio|0.97|||||TWO_SIDED|95.0|0.85|1.11|||||V116 Lot 1/V116 Lot 2|Serotype 7F: GMC Ratio V116 Lot 1/ V116 Lot 2|GMC Ratio and 95% CI were estimated from a cLDA model.|1.11|0.85|
72602706|NCT05464420|144734923|OTHER||GMC Ratio|1.03|||||TWO_SIDED|95.0|0.9|1.18|||||V116 Lot 1/V116 Lot 3|Serotype 7F: GMC Ratio V116 Lot 1/ V116 Lot 3|GMC Ratio and 95% CI were estimated from a cLDA model.|1.18|0.90|
72602707|NCT05464420|144734923|OTHER||GMC Ratio|1.06|||||TWO_SIDED|95.0|0.93|1.21|||||V116 Lot 2/V116 Lot 3|Serotype 7F: GMC Ratio V116 Lot 2/ V116 Lot 3|GMC Ratio and 95% CI were estimated from a cLDA model.|1.21|0.93|
72602708|NCT05464420|144734923|OTHER||GMC Ratio|0.98|||||TWO_SIDED|95.0|0.86|1.12|||||V116 Lot 1/V116 Lot 2|Serotype 8: GMC Ratio V116 Lot 1/ V116 Lot 2|GMC Ratio and 95% CI were estimated from a cLDA model.|1.12|0.86|
72602709|NCT05464420|144734923|OTHER||GMC Ratio|0.99|||||TWO_SIDED|95.0|0.87|1.13|||||V116 Lot 1/V116 Lot 3|Serotype 8: GMC Ratio V116 Lot 1/ V116 Lot 3|GMC Ratio and 95% CI were estimated from a cLDA model.|1.13|0.87|
72602710|NCT05464420|144734923|OTHER||GMC Ratio|1.01|||||TWO_SIDED|95.0|0.89|1.15|||||V116 Lot 2/V116 Lot 3|Serotype 8: GMC Ratio V116 Lot 2/ V116 Lot 3|GMC Ratio and 95% CI were estimated from a cLDA model.|1.15|0.89|
72602711|NCT05464420|144734923|OTHER||GMC Ratio|1.05|||||TWO_SIDED|95.0|0.91|1.21|||||V116 Lot 1/V116 Lot 2|Serotype 9N: GMC Ratio V116 Lot 1/ V116 Lot 2|GMC Ratio and 95% CI were estimated from a cLDA model.|1.21|0.91|
72602712|NCT05464420|144734923|OTHER||GMC Ratio|0.89|||||TWO_SIDED|95.0|0.77|1.03|||||V116 Lot 1/V116 Lot 3|Serotype 9N: GMC Ratio V116 Lot 1/ V116 Lot 3|GMC Ratio and 95% CI were estimated from a cLDA model.|1.03|0.77|
72602713|NCT05464420|144734923|OTHER||GMC Ratio|0.85|||||TWO_SIDED|95.0|0.74|0.98|||||V116 Lot 2/V116 Lot 3|Serotype 9N: GMC Ratio V116 Lot 2/ V116 Lot 3|GMC Ratio and 95% CI were estimated from a cLDA model.|0.98|0.74|
72602714|NCT05464420|144734923|OTHER||GMC Ratio|1.01|||||TWO_SIDED|95.0|0.87|1.18|||||V116 Lot 1/V116 Lot 2|Serotype 10A: GMC Ratio V116 Lot 1/ V116 Lot 2|GMC Ratio and 95% CI were estimated from a cLDA model.|1.18|0.87|
72602715|NCT05464420|144734923|OTHER||GMC Ratio|0.97|||||TWO_SIDED|95.0|0.83|1.13|||||V116 Lot 1/V116 Lot 3|Serotype 10A: GMC Ratio V116 Lot 1/ V116 Lot 3|GMC Ratio and 95% CI were estimated from a cLDA model.|1.13|0.83|
72602716|NCT05464420|144734923|OTHER||GMC Ratio|0.95|||||TWO_SIDED|95.0|0.82|1.11|||||V116 Lot 2/V116 Lot 3|Serotype 10A: GMC Ratio V116 Lot 2/ V116 Lot 3|GMC Ratio and 95% CI were estimated from a cLDA model.|1.11|0.82|
72602717|NCT05464420|144734923|OTHER||GMC Ratio|1.01|||||TWO_SIDED|95.0|0.9|1.14|||||V116 Lot 1/V116 Lot 2|Serotype 11A: GMC Ratio V116 Lot 1/ V116 Lot 2|GMC Ratio and 95% CI were estimated from a cLDA model.|1.14|0.90|
72602718|NCT05464420|144734923|OTHER||GMC Ratio|1.02|||||TWO_SIDED|95.0|0.91|1.15|||||V116 Lot 1/V116 Lot 3|Serotype 11A: GMC Ratio V116 Lot 1/ V116 Lot 3|GMC Ratio and 95% CI were estimated from a cLDA model.|1.15|0.91|
72602719|NCT05464420|144734923|OTHER||GMC Ratio|1.01|||||TWO_SIDED|95.0|0.9|1.14|||||V116 Lot 2/V116 Lot 3|Serotype 11A: GMC Ratio V116 Lot 2/ V116 Lot 3|GMC Ratio and 95% CI were estimated from a cLDA model.|1.14|0.90|
72602720|NCT05464420|144734923|OTHER||GMC Ratio|0.95|||||TWO_SIDED|95.0|0.8|1.12|||||V116 Lot 1/V116 Lot 2|Serotype 12F: GMC Ratio V116 Lot 1/ V116 Lot 2|GMC Ratio and 95% CI were estimated from a cLDA model.|1.12|0.80|
72602721|NCT05464420|144734923|OTHER||GMC Ratio|1.0|||||TWO_SIDED|95.0|0.84|1.18|||||V116 Lot 1/V116 Lot 3|Serotype 12F: GMC Ratio V116 Lot 1/ V116 Lot 3|GMC Ratio and 95% CI were estimated from a cLDA model.|1.18|0.84|
72602722|NCT05464420|144734923|OTHER||GMC Ratio|1.06|||||TWO_SIDED|95.0|0.89|1.25|||||V116 Lot 2/V116 Lot 3|Serotype 12F: GMC Ratio V116 Lot 2/ V116 Lot 3|GMC Ratio and 95% CI were estimated from a cLDA model.|1.25|0.89|
72602723|NCT05464420|144734923|OTHER||GMC Ratio|1.05|||||TWO_SIDED|95.0|0.91|1.21|||||V116 Lot 1/V116 Lot 2|Serotype 15A: GMC Ratio V116 Lot 1/ V116 Lot 2|GMC Ratio and 95% CI were estimated from a cLDA model.|1.21|0.91|
72602724|NCT05464420|144734923|OTHER||GMC Ratio|0.96|||||TWO_SIDED|95.0|0.83|1.11|||||V116 Lot 1/V116 Lot 3|Serotype 15A: GMC Ratio V116 Lot 1/ V116 Lot 3|GMC Ratio and 95% CI were estimated from a cLDA model.|1.11|0.83|
72602725|NCT05464420|144734923|OTHER||GMC Ratio|0.92|||||TWO_SIDED|95.0|0.8|1.05|||||V116 Lot 2/V116 Lot 3|Serotype 15A: GMC Ratio V116 Lot 2/ V116 Lot 3|GMC Ratio and 95% CI were estimated from a cLDA model.|1.05|0.80|
72602726|NCT05464420|144734923|OTHER||GMC Ratio|1.06|||||TWO_SIDED|95.0|0.91|1.23|||||V116 Lot 1/V116 Lot 2|Serotype 15C: GMC Ratio V116 Lot 1/ V116 Lot 2|GMC Ratio and 95% CI were estimated from a cLDA model.|1.23|0.91|
72602727|NCT05464420|144734923|OTHER||GMC Ratio|1.03|||||TWO_SIDED|95.0|0.89|1.2|||||V116 Lot 1/V116 Lot 3|Serotype 15C: GMC Ratio V116 Lot 1/ V116 Lot 3|GMC Ratio and 95% CI were estimated from a cLDA model.|1.20|0.89|
72602728|NCT05464420|144734923|OTHER||GMC Ratio|0.98|||||TWO_SIDED|95.0|0.84|1.14|||||V116 Lot 2/V116 Lot 3|Serotype 15C: GMC Ratio V116 Lot 2/ V116 Lot 3|GMC Ratio and 95% CI were estimated from a cLDA model.|1.14|0.84|
72602729|NCT05464420|144734923|OTHER||GMC Ratio|0.9|||||TWO_SIDED|95.0|0.78|1.03|||||V116 Lot 1/V116 Lot 2|Serotype 16F: GMC Ratio V116 Lot 1/ V116 Lot 2|GMC Ratio and 95% CI were estimated from a cLDA model.|1.03|0.78|
72602730|NCT05464420|144734923|OTHER||GMC Ratio|0.9|||||TWO_SIDED|95.0|0.78|1.04|||||V116 Lot 1/V116 Lot 3|Serotype 16F: GMC Ratio V116 Lot 1/ V116 Lot 3|GMC Ratio and 95% CI were estimated from a cLDA model.|1.04|0.78|
72602731|NCT05464420|144734923|OTHER||GMC Ratio|1.01|||||TWO_SIDED|95.0|0.88|1.15|||||V116 Lot 2/V116 Lot 3|Serotype 16F: GMC Ratio V116 Lot 2/ V116 Lot 3|GMC Ratio and 95% CI were estimated from a cLDA model.|1.15|0.88|
72602732|NCT05464420|144734923|OTHER||GMC Ratio|1.05|||||TWO_SIDED|95.0|0.91|1.21|||||V116 Lot 1/V116 Lot 2|Serotype 17F: GMC Ratio V116 Lot 1/ V116 Lot 2|GMC Ratio and 95% CI were estimated from a cLDA model.|1.21|0.91|
72552585|NCT00909610|144635990|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of Variance (ANOVA) will be applied to log-transformed AUC's and Cmax parameters.|Ratio of the Geometric Mean|105.0||||||90.0|100.0|111.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||111|100|
72552586|NCT00909610|144635991|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of Variance (ANOVA) will be applied to log-transformed AUC's and Cmax parameters.|Ratio of the Mean|101.0||||||90.0|92.5|111.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||111|92.5|
72552587|NCT00909610|144635992|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of Variance (ANOVA) will be applied to log-transformed AUC's and Cmax parameters.|Ratio of the Mean|110.0||||||90.0|103.0|117.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||117|103|
72552588|NCT00909610|144635993|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of Variance (ANOVA) will be applied to log-transformed AUC's and Cmax parameters.|Ratio of the Mean|101.0||||||90.0|92.2|111.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||111|92.2|
72552589|NCT00909610|144635994|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of Variance (ANOVA) will be applied to log-transformed AUC's and Cmax parameters.|Ratio of the Mean|107.0||||||90.0|100.0|115.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||115|100|
72602733|NCT05464420|144734923|OTHER||GMC Ratio|1.07|||||TWO_SIDED|95.0|0.93|1.23|||||V116 Lot 1/V116 Lot 3|Serotype 17F: GMC Ratio V116 Lot 1/ V116 Lot 3|GMC Ratio and 95% CI were estimated from a cLDA model.|1.23|0.93|
72602734|NCT05464420|144734923|OTHER||GMC Ratio|1.02|||||TWO_SIDED|95.0|0.88|1.17|||||V116 Lot 2/V116 Lot 3|Serotype 17F: GMC Ratio V116 Lot 2/ V116 Lot 3|GMC Ratio and 95% CI were estimated from a cLDA model.|1.17|0.88|
72602735|NCT05464420|144734923|OTHER||GMC Ratio|0.97|||||TWO_SIDED|95.0|0.85|1.11|||||V116 Lot 1/V116 Lot 2|Serotype 19A: GMC Ratio V116 Lot 1/ V116 Lot 2|GMC Ratio and 95% CI were estimated from a cLDA model.|1.11|0.85|
72602736|NCT05464420|144734923|OTHER||GMC Ratio|0.9|||||TWO_SIDED|95.0|0.79|1.04|||||V116 Lot 1/V116 Lot 3|Serotype 19A: GMC Ratio V116 Lot 1/ V116 Lot 3|GMC Ratio and 95% CI were estimated from a cLDA model.|1.04|0.79|
72602737|NCT05464420|144734923|OTHER||GMC Ratio|0.93|||||TWO_SIDED|95.0|0.82|1.07|||||V116 Lot 2/V116 Lot 3|Serotype 19A: GMC Ratio V116 Lot 2/ V116 Lot 3|GMC Ratio and 95% CI were estimated from a cLDA model.|1.07|0.82|
72602738|NCT05464420|144734923|OTHER||GMC Ratio|0.95|||||TWO_SIDED|95.0|0.83|1.1|||||V116 Lot 1/V116 Lot 2|Serotype 20A: GMC Ratio V116 Lot 1/ V116 Lot 2|GMC Ratio and 95% CI were estimated from a cLDA model.|1.10|0.83|
72602739|NCT05464420|144734923|OTHER||GMC Ratio|0.96|||||TWO_SIDED|95.0|0.84|1.1|||||V116 Lot 1/V116 Lot 3|Serotype 20A: GMC Ratio V116 Lot 1/ V116 Lot 3|GMC Ratio and 95% CI were estimated from a cLDA model.|1.10|0.84|
72602740|NCT05464420|144734923|OTHER||GMC Ratio|1.01|||||TWO_SIDED|95.0|0.88|1.16|||||V116 Lot 2/V116 Lot 3|Serotype 20A: GMC Ratio V116 Lot 2/ V116 Lot 3|GMC Ratio and 95% CI were estimated from a cLDA model.|1.16|0.88|
72602741|NCT05464420|144734923|OTHER||GMC Ratio|1.01|||||TWO_SIDED|95.0|0.87|1.16|||||V116 Lot 1/V116 Lot 2|Serotype 22F: GMC Ratio V116 Lot 1/ V116 Lot 2|GMC Ratio and 95% CI were estimated from a cLDA model.|1.16|0.87|
72602742|NCT05464420|144734923|OTHER||GMC Ratio|1.0|||||TWO_SIDED|95.0|0.87|1.16|||||V116 Lot 1/V116 Lot 3|Serotype 22F: GMC Ratio V116 Lot 1/ V116 Lot 3|GMC Ratio and 95% CI were estimated from a cLDA model.|1.16|0.87|
72416240|NCT01972841|144343300|SUPERIORITY||least square mean difference|-2.36|STANDARD_ERROR_OF_MEAN|0.83|<|0.001|TWO_SIDED|95.0|-4.0|-0.73|||Stratified rank ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the mirabegron 25 mg monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||-0.73|-4.00|<0.001
72602743|NCT05464420|144734923|OTHER||GMC Ratio|1.0|||||TWO_SIDED|95.0|0.86|1.15|||||V116 Lot 2/V116 Lot 3|Serotype 22F: GMC Ratio V116 Lot 2/ V116 Lot 3|GMC Ratio and 95% CI were estimated from a cLDA model.|1.15|0.86|
72602744|NCT05464420|144734923|OTHER||GMC Ratio|0.98|||||TWO_SIDED|95.0|0.84|1.16|||||V116 Lot 1/V116 Lot 2|Serotype 23A: GMC Ratio V116 Lot 1/ V116 Lot 2|GMC Ratio and 95% CI were estimated from a cLDA model.|1.16|0.84|
72602745|NCT05464420|144734923|OTHER||GMC Ratio|0.98|||||TWO_SIDED|95.0|0.83|1.15|||||V116 Lot 1/V116 Lot 3|Serotype 23A: GMC Ratio V116 Lot 1/ V116 Lot 3|GMC Ratio and 95% CI were estimated from a cLDA model.|1.15|0.83|
72602746|NCT05464420|144734923|OTHER||GMC Ratio|1.0|||||TWO_SIDED|95.0|0.85|1.17|||||V116 Lot 2/V116 Lot 3|Serotype 23A: GMC Ratio V116 Lot 2/ V116 Lot 3|GMC Ratio and 95% CI were estimated from a cLDA model.|1.17|0.85|
72602747|NCT05464420|144734923|OTHER||GMC Ratio|1.02|||||TWO_SIDED|95.0|0.87|1.18|||||V116 Lot 1/V116 Lot 2|Serotype 23B: GMC Ratio V116 Lot 1/ V116 Lot 2|GMC Ratio and 95% CI were estimated from a cLDA model.|1.18|0.87|
72602748|NCT05464420|144734923|OTHER||GMC Ratio|0.92|||||TWO_SIDED|95.0|0.79|1.07|||||V116 Lot 1/V116 Lot 3|Serotype 23B: GMC Ratio V116 Lot 1/ V116 Lot 3|GMC Ratio and 95% CI were estimated from a cLDA model.|1.07|0.79|
72602749|NCT05464420|144734923|OTHER||GMC Ratio|0.9|||||TWO_SIDED|95.0|0.77|1.05|||||V116 Lot 2/V116 Lot 3|Serotype 23B: GMC Ratio V116 Lot 2/ V116 Lot 3|GMC Ratio and 95% CI were estimated from a cLDA model.|1.05|0.77|
72602750|NCT05464420|144734923|OTHER||GMC Ratio|0.95|||||TWO_SIDED|95.0|0.8|1.13|||||V116 Lot 1/V116 Lot 2|Serotype 24F: GMC Ratio V116 Lot 1/ V116 Lot 2|GMC Ratio and 95% CI were estimated from a cLDA model.|1.13|0.80|
72602751|NCT05464420|144734923|OTHER||GMC Ratio|1.0|||||TWO_SIDED|95.0|0.84|1.19|||||V116 Lot 1/V116 Lot 3|Serotype 24F: GMC Ratio V116 Lot 1/ V116 Lot 3|GMC Ratio and 95% CI were estimated from a cLDA model.|1.19|0.84|
72602752|NCT05464420|144734923|OTHER||GMC Ratio|1.05|||||TWO_SIDED|95.0|0.88|1.25|||||V116 Lot 2/V116 Lot 3|Serotype 24F: GMC Ratio V116 Lot 2/ V116 Lot 3|GMC Ratio and 95% CI were estimated from a cLDA model.|1.25|0.88|
72602753|NCT05464420|144734923|OTHER||GMC Ratio|0.88|||||TWO_SIDED|95.0|0.77|1.0|||||V116 Lot 1/V116 Lot 2|Serotype 31: GMC Ratio V116 Lot 1/ V116 Lot 2|GMC Ratio and 95% CI were estimated from a cLDA model.|1.00|0.77|
72602754|NCT05464420|144734923|OTHER||GMC Ratio|1.0|||||TWO_SIDED|95.0|0.88|1.14|||||V116 Lot 1/V116 Lot 3|Serotype 31: GMC Ratio V116 Lot 1/ V116 Lot 3|GMC Ratio and 95% CI were estimated from a cLDA model.|1.14|0.88|
72602755|NCT05464420|144734923|OTHER||GMC Ratio|1.14|||||TWO_SIDED|95.0|1.0|1.3|||||V116 Lot 2/V116 Lot 3|Serotype 31: GMC Ratio V116 Lot 2/ V116 Lot 3|GMC Ratio and 95% CI were estimated from a cLDA model.|1.30|1.00|
72602756|NCT05464420|144734923|OTHER||GMC Ratio|1.01|||||TWO_SIDED|95.0|0.89|1.16|||||V116 Lot 1/V116 Lot 2|Serotype 33F: GMC Ratio V116 Lot 1/ V116 Lot 2|GMC Ratio and 95% CI were estimated from a cLDA model.|1.16|0.89|
72602757|NCT05464420|144734923|OTHER||GMC Ratio|1.0|||||TWO_SIDED|95.0|0.88|1.15|||||V116 Lot 1/V116 Lot 3|Serotype 33F: GMC Ratio V116 Lot 1/ V116 Lot 3|GMC Ratio and 95% CI were estimated from a cLDA model.|1.15|0.88|
72602758|NCT05464420|144734923|OTHER||GMC Ratio|0.99|||||TWO_SIDED|95.0|0.87|1.13|||||V116 Lot 2/V116 Lot 3|Serotype 33F: GMC Ratio V116 Lot 2/ V116 Lot 3|GMC Ratio and 95% CI were estimated from a cLDA model.|1.13|0.87|
72602759|NCT05464420|144734923|OTHER||GMC Ratio|1.02|||||TWO_SIDED|95.0|0.9|1.17|||||V116 Lot 1/V116 Lot 2|Serotype 35B: GMC Ratio V116 Lot 1/ V116 Lot 3|GMC Ratio and 95% CI were estimated from a cLDA model.|1.17|0.90|
72602760|NCT05464420|144734923|OTHER||GMC Ratio|0.99|||||TWO_SIDED|95.0|0.87|1.13|||||V116 Lot 1/V116 Lot 3|Serotype 35B: GMC Ratio V116 Lot 1/ V116 Lot 3|GMC Ratio and 95% CI were estimated from a cLDA model.|1.13|0.87|
72602761|NCT05464420|144734923|OTHER||GMC Ratio|0.97|||||TWO_SIDED|95.0|0.85|1.1|||||V116 Lot 2/V116 Lot 3|Serotype 35B: GMC Ratio V116 Lot 2/ V116 Lot 3|GMC Ratio and 95% CI were estimated from a cLDA model.|1.10|0.85|
72602762|NCT05464420|144734924|OTHER||GMC Ratio|1.1|||||TWO_SIDED|95.0|1.01|1.21|||||V116 Combined Lots/PPSV23|Serotype 3: GMC Ratio V116 Combined Lots/ PPSV23|GMC Ratio and 95% CI were estimated from a cLDA model.|1.21|1.01|
72602763|NCT05464420|144734924|OTHER||GMC Ratio|3.91|||||TWO_SIDED|95.0|3.43|4.45|||||V116 Combined Lots/PPSV23|Serotype 6A: GMC Ratio V116 Combined Lots/ PPSV23|GMC Ratio and 95% CI were estimated from a cLDA model.|4.45|3.43|
72602764|NCT05464420|144734924|OTHER||GMC Ratio|1.54|||||TWO_SIDED|95.0|1.38|1.72|||||V116 Combined Lots/PPSV23|Serotype 7F: GMC Ratio V116 Combined Lots/ PPSV23|GMC Ratio and 95% CI were estimated from a cLDA model.|1.72|1.38|
72602765|NCT05464420|144734924|OTHER||GMC Ratio|0.81|||||TWO_SIDED|95.0|0.73|0.89|||||V116 Combined Lots/PPSV23|Serotype 8: GMC Ratio V116 Combined Lots/ PPSV23|GMC Ratio and 95% CI were estimated from a cLDA model.|0.89|0.73|
72602766|NCT05464420|144734924|OTHER||GMC Ratio|1.02|||||TWO_SIDED|95.0|0.91|1.14|||||V116 Combined Lots/PPSV23|Serotype 9N: GMC Ratio V116 Combined Lots/ PPSV23|GMC Ratio and 95% CI were estimated from a cLDA model.|1.14|0.91|
72602767|NCT05464420|144734924|OTHER||GMC Ratio|1.47|||||TWO_SIDED|95.0|1.3|1.66|||||V116 Combined Lots/PPSV23|Serotype 10A: GMC Ratio V116 Combined Lots/ PPSV23|GMC Ratio and 95% CI were estimated from a cLDA model.|1.66|1.30|
72602768|NCT05464420|144734924|OTHER||GMC Ratio|1.38|||||TWO_SIDED|95.0|1.26|1.52|||||V116 Combined Lots/PPSV23|Serotype 11A: GMC Ratio V116 Combined Lots/ PPSV23|GMC Ratio and 95% CI were estimated from a cLDA model.|1.52|1.26|
72602769|NCT05464420|144734924|OTHER||GMC Ratio|1.41|||||TWO_SIDED|95.0|1.23|1.62|||||V116 Combined Lots/PPSV23|Serotype 12F: GMC Ratio V116 Combined Lots/ PPSV23|GMC Ratio and 95% CI were estimated from a cLDA model.|1.62|1.23|
72602770|NCT05464420|144734924|OTHER||GMC Ratio|6.82|||||TWO_SIDED|95.0|6.08|7.65|||||V116 Combined Lots/PPSV23|Serotype 15A: GMC Ratio V116 Combined Lots/ PPSV23|GMC Ratio and 95% CI were estimated from a cLDA model.|7.65|6.08|
72602771|NCT05464420|144734924|OTHER||GMC Ratio|3.24|||||TWO_SIDED|95.0|2.86|3.67|||||V116 Combined Lots/PPSV23|Serotype 15C: GMC Ratio V116 Combined Lots/ PPSV23|GMC Ratio and 95% CI were estimated from a cLDA model.|3.67|2.86|
72602772|NCT05464420|144734924|OTHER||GMC Ratio|6.48|||||TWO_SIDED|95.0|5.83|7.19|||||V116 Combined Lots/PPSV23|Serotype 16F: GMC Ratio V116 Combined Lots/ PPSV23|GMC Ratio and 95% CI were estimated from a cLDA model.|7.19|5.83|
72602773|NCT05464420|144734924|OTHER||GMC Ratio|1.85|||||TWO_SIDED|95.0|1.66|2.07|||||V116 Combined Lots/PPSV23|Serotype 17F: GMC Ratio V116 Combined Lots/ PPSV23|GMC Ratio and 95% CI were estimated from a cLDA model.|2.07|1.66|
72602774|NCT05464420|144734924|OTHER||GMC Ratio|1.1|||||TWO_SIDED|95.0|0.98|1.22|||||V116 Combined Lots/PPSV23|Serotype 19A: GMC Ratio V116 Combined Lots/ PPSV23|GMC Ratio and 95% CI were estimated from a cLDA model.|1.22|0.98|
72602775|NCT05464420|144734924|OTHER||GMC Ratio|1.53|||||TWO_SIDED|95.0|1.37|1.71|||||V116 Combined Lots/PPSV23|Serotype 20A: GMC Ratio V116 Combined Lots/ PPSV23|GMC Ratio and 95% CI were estimated from a cLDA model.|1.71|1.37|
72602776|NCT05464420|144734924|OTHER||GMC Ratio|1.32|||||TWO_SIDED|95.0|1.17|1.49|||||V116 Combined Lots/PPSV23|Serotype 22F: GMC Ratio V116 Combined Lots/ PPSV23|GMC Ratio and 95% CI were estimated from a cLDA model.|1.49|1.17|
72602777|NCT05464420|144734924|OTHER||GMC Ratio|8.14|||||TWO_SIDED|95.0|7.19|9.23|||||V116 Combined Lots/PPSV23|Serotype 23A: GMC Ratio V116 Combined Lots/ PPSV23|GMC Ratio and 95% CI were estimated from a cLDA model.|9.23|7.19|
72602778|NCT05464420|144734924|OTHER||GMC Ratio|5.74|||||TWO_SIDED|95.0|5.08|6.48|||||V116 Combined Lots/PPSV23|Serotype 23B: GMC Ratio V116 Combined Lots/ PPSV23|GMC Ratio and 95% CI were estimated from a cLDA model.|6.48|5.08|
72602779|NCT05464420|144734924|OTHER||GMC Ratio|14.47|||||TWO_SIDED|95.0|12.77|16.4|||||V116 Combined Lots/PPSV23|Serotype 24F: GMC Ratio V116 Combined Lots/ PPSV23|GMC Ratio and 95% CI were estimated from a cLDA model.|16.40|12.77|
72602780|NCT05464420|144734924|OTHER||GMC Ratio|9.55|||||TWO_SIDED|95.0|8.61|10.59|||||V116 Combined Lots/PPSV23|Serotype 31: GMC Ratio V116 Combined Lots/ PPSV23|GMC Ratio and 95% CI were estimated from a cLDA model.|10.59|8.61|
72602781|NCT05464420|144734924|OTHER||GMC Ratio|0.81|||||TWO_SIDED|95.0|0.73|0.91|||||V116 Combined Lots/PPSV23|Serotype 33F: GMC Ratio V116 Combined Lots/ PPSV23|GMC Ratio and 95% CI were estimated from a cLDA model.|0.91|0.73|
72602782|NCT05464420|144734924|OTHER||GMC Ratio|7.06|||||TWO_SIDED|95.0|6.41|7.77|||||V116 Combined Lots/PPSV23|Serotype 35B: GMC Ratio V116 Combined Lots/ PPSV23|GMC Ratio and 95% CI were estimated from a cLDA model.|7.77|6.41|
72602783|NCT01603407|144734969|SUPERIORITY|||||||0.3904|||||||Mixed Models Analysis|||||||0.3904
72602784|NCT01603407|144734969|SUPERIORITY|||||||0.569|||||||Mixed Models Analysis|||||||0.5690
72602785|NCT01603407|144734969|SUPERIORITY|||||||0.1518|||||||Mixed Models Analysis|||||||0.1518
72602786|NCT01603407|144734970|SUPERIORITY|||||||0.7365|||||||Mixed Models Analysis|||||||0.7365
72602787|NCT01603407|144734970|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||||||<0.0001
72602788|NCT01603407|144734970|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||||||<0.0001
72602789|NCT01603407|144734971|SUPERIORITY|||||||0.2456|||||||Mixed Models Analysis|||||||0.2456
72602790|NCT01603407|144734971|SUPERIORITY|||||||0.0369|||||||Mixed Models Analysis|||||||0.0369
72602791|NCT01603407|144734971|SUPERIORITY|||||||0.3589|||||||Mixed Models Analysis|||||||0.3589
72602792|NCT01603407|144734972|SUPERIORITY|||||||0.7335|||||||Mixed Models Analysis|||||||0.7335
72602793|NCT01603407|144734972|SUPERIORITY|||||||0.0004|||||||Mixed Models Analysis|||||||0.0004
72602794|NCT01603407|144734972|SUPERIORITY|||||||0.0001|||||||Mixed Models Analysis|||||||0.0001
72602795|NCT01603407|144734973|SUPERIORITY|||||||0.9532|||||||Mixed Models Analysis|||||||0.9532
72602796|NCT01603407|144734973|SUPERIORITY|||||||0.004|||||||Mixed Models Analysis|||||||0.0040
72602797|NCT01603407|144734973|SUPERIORITY|||||||0.0046|||||||Mixed Models Analysis|||||||0.0046
72602798|NCT01603407|144734974|SUPERIORITY|||||||0.332|||||||Mixed Models Analysis|||||||0.3320
72602799|NCT01603407|144734974|SUPERIORITY|||||||0.1248|||||||Mixed Models Analysis|||||||0.1248
72602800|NCT01603407|144734974|SUPERIORITY|||||||0.5854|||||||Mixed Models Analysis|||||||0.5854
72602801|NCT01603407|144734975|SUPERIORITY|||||||0.30814|||||||Mixed Models Analysis|||||||0.30814
72602802|NCT01603407|144734975|SUPERIORITY|||||||0.1405|||||||Mixed Models Analysis|||||||0.1405
72602803|NCT01603407|144734975|SUPERIORITY|||||||0.664|||||||Mixed Models Analysis|||||||0.6640
72602804|NCT01603407|144734977|SUPERIORITY|||||||0.8345|||||||Mixed Models Analysis|||||||0.8345
72602805|NCT01603407|144734977|SUPERIORITY|||||||0.3762|||||||Mixed Models Analysis|||||||0.3762
72602806|NCT01603407|144734977|SUPERIORITY|||||||0.5059|||||||Mixed Models Analysis|||||||0.5059
72602807|NCT01603407|144734978|SUPERIORITY|||||||0.5947|||||||Mixed Models Analysis|||||||0.5947
72602808|NCT01603407|144734978|SUPERIORITY|||||||0.1098|||||||Mixed Models Analysis|||||||0.1098
72602809|NCT01603407|144734978|SUPERIORITY|||||||0.2803|||||||Mixed Models Analysis|||||||0.2803
72602810|NCT01603407|144734979|SUPERIORITY|||||||0.3875|||||||Mixed Models Analysis|||||||0.3875
72602811|NCT01603407|144734979|SUPERIORITY|||||||0.424|||||||Mixed Models Analysis|||||||0.4240
72602812|NCT01603407|144734979|SUPERIORITY|||||||0.9683|||||||Mixed Models Analysis|||||||0.9683
72602813|NCT01603407|144734980|SUPERIORITY|||||||0.6161|||||||Mixed Models Analysis|||||||0.6161
72602814|NCT01603407|144734980|SUPERIORITY|||||||0.7302|||||||Mixed Models Analysis|||||||0.7302
72602815|NCT01603407|144734980|SUPERIORITY|||||||0.9007|||||||Mixed Models Analysis|||||||0.9007
72602816|NCT01603407|144734981|SUPERIORITY|||||||0.8138|||||||Mixed Models Analysis|||||||0.8138
72602817|NCT01603407|144734981|SUPERIORITY|||||||0.5995|||||||Mixed Models Analysis|||||||0.5995
72602818|NCT01603407|144734981|SUPERIORITY|||||||0.7616|||||||Mixed Models Analysis|||||||0.7616
72602819|NCT01603407|144734982|SUPERIORITY|||||||0.68|||||||Mixed Models Analysis|||||||0.6800
72602820|NCT01603407|144734982|SUPERIORITY|||||||0.4365|||||||Mixed Models Analysis|||||||0.4365
72602821|NCT01603407|144734982|SUPERIORITY|||||||0.7281|||||||Mixed Models Analysis|||||||0.7281
72602822|NCT01603407|144734983|SUPERIORITY||Mean Difference (Net)|-1.545||||0.0041|TWO_SIDED|98.3|-2.6611|-0.2479|||Mixed Models Analysis|||||-0.2479|-2.6611|0.0041
72602823|NCT01603407|144734983|SUPERIORITY||Mean Difference (Net)|0.9076||||0.9076|TWO_SIDED|98.3|-1.248|1.1331|||Mixed Models Analysis|||||1.1331|-1.248|0.9076
72602824|NCT01603407|144734983|SUPERIORITY||Mean Difference (Net)|1.3971||||0.0054|TWO_SIDED|98.3|0.2014|2.5927|||Mixed Models Analysis|||||2.5927|0.2014|0.0054
72602825|NCT01603407|144734984|SUPERIORITY||Mean Difference (Net)|-1.48|||<|0.0001|TWO_SIDED|98.3|-2.3242|-0.6358|||Mixed Models Analysis|||||-0.6358|-2.3242|<0.0001
72602826|NCT01603407|144734984|SUPERIORITY||Mean Difference (Net)|3.054|||<|0.0001|TWO_SIDED|98.3|2.2222|3.8857|||Mixed Models Analysis|||||3.8857|2.2222|<0.0001
72602827|NCT01603407|144734984|SUPERIORITY||Mean Difference (Net)|4.534|||<|0.0001|TWO_SIDED|98.3|3.6941|5.3738|||Mixed Models Analysis|||||5.3738|3.6941|<0.0001
72602828|NCT01603407|144734985|SUPERIORITY||Mean Difference (Net)|-0.6205||||0.0853|TWO_SIDED|98.3|-1.4845|0.2434|||Mixed Models Analysis|||||0.2434|-1.4845|0.0853
72602829|NCT01603407|144734985|SUPERIORITY||Mean Difference (Net)|-0.876||||0.0143|TWO_SIDED|98.3|-1.7292|-0.0229|||Mixed Models Analysis|||||-0.0229|-1.7292|0.0143
72602830|NCT01603407|144734985|SUPERIORITY||Mean Difference (Net)|-0.2555||||0.4731|TWO_SIDED|98.3|-1.1117|0.6007|||Mixed Models Analysis|||||0.6007|-1.1117|0.4731
72602831|NCT02500719|144734986|SUPERIORITY||Mean Difference (Net)|0.1319||||0.029|ONE_SIDED||||||t-test, 1 sided|||This test is to determine if the difference between engagement and disengagement of emotional arousal is increased by real-time neurofeedback guidance in PTSD participants.||||.029
72602832|NCT01990768|144734987|SUPERIORITY||Odds Ratio (OR)|0.87||||0.1809|ONE_SIDED|||||Based on an interim futility analysis, a one-sided P-value less than .1028 was required to declare benefit.|Regression, Logistic|Analysis was adjusted for regional site. Missing outcomes were multiply imputed.|Odds ratio for unfavorable GOS-E (\<=4) for the Combined TXA Arms (numerator) vs. Placebo (denominator)|This study was designed with an asymmetric boundary for tests for treatment harm and benefit. The conventional 0.025 level was used to test for harm while a 0.1 level was used to determine benefit for this Phase II trial. Statistical significance for the primary analysis was conducted under a group-sequential design that included a single, interim futility analysis using a Wang-Tsiatis boundary with parameter 0.8 based on outcome data from the first 200 subjects.||||.1809
72602833|NCT03538691|144735006|SUPERIORITY||Hazard Ratio (HR)|1.138||||0.51|TWO_SIDED|95.0|0.776|1.669|||Log Rank||The hazard ratio and 95% confidence interval (CI) were derived from the Cox proportional hazard model with treatment as fixed effect.|||1.669|0.776|0.5100
72602834|NCT03538691|144735007|SUPERIORITY||Least Squares (LS) Mean Difference|0.23||||0.2393|TWO_SIDED|95.0|-0.16|0.62||P-value was derived from an ANCOVA model with treatment, pooled center as factor and Baseline value as covariance.|ANCOVA|||||0.62|-0.16|0.2393
72602835|NCT03538691|144735008|SUPERIORITY||Hazard Ratio (HR)|1.177||||0.3086|TWO_SIDED|95.0|0.857|1.615|||Log Rank||The hazard ratio and 95% CI were derived from the Cox proportional hazard model with treatment as fixed effect.|||1.615|0.857|0.3086
72602836|NCT03538691|144735009|SUPERIORITY|||||||0.603|||||||Chi-squared|||||||0.6030
72602837|NCT03538691|144735010|SUPERIORITY|||||||0.7081|||||||Chi-squared|||Week 21||||0.7081
72602838|NCT03538691|144735010|SUPERIORITY|||||||0.4589|||||||Chi-squared|||Week 23||||0.4589
72602839|NCT03538691|144735010|SUPERIORITY|||||||0.5314|||||||Chi-squared|||Week 25||||0.5314
72602840|NCT03538691|144735010|SUPERIORITY|||||||0.1433|||||||Chi-squared|||Week 29||||0.1433
72602841|NCT03538691|144735010|SUPERIORITY|||||||0.9636|||||||Chi-squared|||Week 33||||0.9636
72602842|NCT03538691|144735010|SUPERIORITY|||||||0.7596|||||||Chi-squared|||Week 37||||0.7596
72602843|NCT03538691|144735010|SUPERIORITY|||||||0.2402|||||||Chi-squared|||Week 41||||0.2402
72602844|NCT03538691|144735010|SUPERIORITY|||||||0.8363|||||||Chi-squared|||Week 45||||0.8363
72602845|NCT03538691|144735010|SUPERIORITY|||||||0.8308|||||||Chi-squared|||Week 46||||0.8308
72602846|NCT03538691|144735011|SUPERIORITY||LS Mean Difference|-0.12||||0.8806|TWO_SIDED|95.0|-1.73|1.49|||ANCOVA|P-value was derived from an ANCOVA model with treatment, pooled center as factor and Baseline value as covariance.||||1.49|-1.73|0.8806
72602847|NCT03538691|144735012|SUPERIORITY||LS Mean Difference|0.03||||0.7956|TWO_SIDED|95.0|-0.18|0.24|||ANCOVA|P-value was derived from an ANCOVA model with treatment, pooled center as factor and Baseline value as covariance.||||0.24|-0.18|0.7956
72602848|NCT03538691|144735013|SUPERIORITY||LS Mean Difference|0.15||||0.5223|TWO_SIDED|95.0|-0.31|0.61||P-value was derived from an ANCOVA model with treatment, pooled center as factor and Baseline value as covariance.|ANCOVA|||SDS Individual Item: Work/School||0.61|-0.31|0.5223
72602849|NCT03538691|144735013|SUPERIORITY||LS Mean Difference|0.36||||0.0904|TWO_SIDED|95.0|-0.06|0.77||P-value was derived from an ANCOVA model with treatment, pooled center as factor and Baseline value as covariance.|ANCOVA|||SDS Individual Item: Social Life||0.77|-0.06|0.0904
72602850|NCT03538691|144735013|SUPERIORITY||LS Mean Difference|0.25||||0.2289|TWO_SIDED|95.0|-0.16|0.67||P-value was derived from an ANCOVA model with treatment, pooled center as factor and Baseline value as covariance.|ANCOVA|||SDS Individual Item: Family Life||0.67|-0.16|0.2289
72602851|NCT06597084|144735018|OTHER||Percentiles of time to first US|92.0||||0.2081|TWO_SIDED|95.0|25.0|95.0|||Log Rank|||||95|25|0.2081
72602852|NCT06597084|144735024|OTHER||Overall Survival|||||0.0542|||||||Log Rank|||||||0.0542
72602853|NCT03479944|144735049|SUPERIORITY||Least Squares Mean Difference|-1.505|||<|0.0001|TWO_SIDED|95.0|-1.72|-1.289|||t-test based on MMRM|MMRM: Mixed Model for Repeated Measures|Least Squares Mean Difference from a Mixed Model for Repeated Measures|||-1.289|-1.720|<0.0001
72602854|NCT03479944|144735050|SUPERIORITY||Least Squares Mean Difference|1.2||||0.2602|TWO_SIDED|95.0|-0.9|3.3|||t-test based on MMRM|MMRM: Mixed Model for Repeated Measures|Least Squares Mean Difference from a Mixed Model for Repeated Measures|||3.3|-0.9|0.2602
72602855|NCT03479944|144735051|SUPERIORITY||Least Squares Mean Difference|-11.52|||||TWO_SIDED|95.0|-15.87|-7.18|||||Least Squares Mean Difference from a Mixed Model for Repeated Measures|||-7.18|-15.87|
72602856|NCT02029274|144735054|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.551|STANDARD_ERROR_OF_MEAN|11.5519||0.9621|TWO_SIDED|95.0|-22.447|23.549|||Repeated measures analysis|||||23.549|-22.447|0.9621
72602857|NCT02029274|144735054|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-15.368|STANDARD_ERROR_OF_MEAN|10.9297||0.1637|TWO_SIDED|95.0|-37.128|6.391|||Repeated measures analysis|||||6.391|-37.128|0.1637
72602858|NCT02029274|144735054|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-13.709|STANDARD_ERROR_OF_MEAN|11.6016||0.2409|TWO_SIDED|95.0|-36.806|9.388|||Repeated measures|||||9.388|-36.806|0.2409
72602859|NCT01243177|144735068|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|"The hypothesis was as follows:~H0: \[S(t)LCM\] - \[S(t)CBZ-CR\] ≤ -12 % versus HA: \[S(t)LCM\] - \[S(t)CBZ-CR\] \> -12 %, where S(t) (t= 182 days) is the cumulative rate of subjects remaining seizure free for 6 months following stabilization at the last evaluated dose (also known as the survivorship function), and -12 % represents the noninferiority margin based on absolute difference."|Mean Difference (Final Values)|-1.3|||||TWO_SIDED|95.0|-5.5|2.8|||Mantel Haenszel|The analysis was stratified based on the number of seizures in the 3 months preceding enrollment (≤ 2 and \>2).|The lower limit of the confidence interval was \>-12 %, noninferiority of LCM to CBZ-CR was demonstrated. Additionally, the lower confidence limit relative to the CBZ-CR seizure freedom rate was \>- 20 %.|This was a noninferiority assessment of Lacosamide versus Carbamazepine-CR for the proportion of subjects remaining seizure free for 6 months at the last evaluated dose.||2.8|-5.5|
72602860|NCT01243177|144735069|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|"The hypothesis was as follows:~H0: \[S(t)LCM\] - \[S(t)CBZ-CR\] ≤ -12 % versus HA: \[S(t)LCM\] - \[S(t)CBZ-CR\] \> -12 %, where S(t) (t= 182 days) is the cumulative rate of subjects remaining seizure free for 6 months following stabilization at the last evaluated dose (also known as the survivorship function), and -12 % represents the noninferiority margin based on absolute difference."|Mean Difference (Final Values)|-1.3|||||TWO_SIDED|95.0|-5.3|2.7|||Mantel Haenszel|The analysis was stratified based on the number of seizures in the 3 months preceding enrollment (≤ 2 and \>2).|The lower limit of the confidence interval was \>-12 %, noninferiority of LCM to CBZ-CR was demonstrated. Additionally, the lower confidence limit relative to the CBZ-CR seizure freedom rate was \>- 20 %.|This was a noninferiority assessment of Lacosamide versus Carbamazepine-CR for the proportion of subjects remaining seizure free for 6 months at the last evaluated dose.||2.7|-5.3|
72602861|NCT03654729|144735076|SUPERIORITY||Risk Ratio (RR)|1.3842||||0.2266|TWO_SIDED|95.0|0.8172|2.3446|||Cochran-Mantel-Haenszel|||Cochran-Mantel-Haenszel estimate of the common relative risk of moderate to severe CIPN.||2.3446|0.8172|0.2266
72602862|NCT03654729|144735076|SUPERIORITY||Risk Ratio (RR)|1.0951||||0.7434|TWO_SIDED|95.0|0.6356|1.887|||Cochran-Mantel-Haenszel|||Cochran-Mantel-Haenszel estimate of the common relative risk of moderate to severe CIPN.||1.8870|0.6356|0.7434
72602863|NCT04530838|144735098|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC (SC) is to the corresponding serotype in 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC SC - 13vPnC SC) was greater than -10%.|Percentage Difference|-1.4|||||TWO_SIDED|95.0|-4.4|1.3||||||Serotype 1: 2-Sided 95% CIs are calculated using the Miettinen and Nurminen method for the difference in proportions, expressed as a percentage.||1.3|-4.4|
72602864|NCT04530838|144735098|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC (SC) is to the corresponding serotype in 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC SC - 13vPnC SC) was greater than -10%.|Percentage Difference|-2.7|||||TWO_SIDED|95.0|-6.2|0.1||||||Serotype 3: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.||0.1|-6.2|
72602865|NCT04530838|144735098|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC (SC) is to the corresponding serotype in 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC SC - 13vPnC SC) was greater than -10%.|Percentage Difference|-2.3|||||TWO_SIDED|95.0|-5.6|0.5||||||Serotype 4: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.||0.5|-5.6|
72602866|NCT04530838|144735098|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC (SC) is to the corresponding serotype in 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC SC - 13vPnC SC) was greater than -10%.|Percentage Difference|-5.0|||||TWO_SIDED|95.0|-9.6|-0.9||||||Serotype 5: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.||-0.9|-9.6|
72602867|NCT04530838|144735098|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC (SC) is to the corresponding serotype in 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC SC - 13vPnC SC) was greater than -10%.|Percentage Difference|-8.1|||||TWO_SIDED|95.0|-13.0|-4.0||||||Serotype 6A: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.||-4.0|-13.0|
72602868|NCT04530838|144735098|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC (SC) is to the corresponding serotype in 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC SC - 13vPnC SC) was greater than -10%.|Percentage Difference|-8.6|||||TWO_SIDED|95.0|-14.0|-3.7||||||Serotype 6B: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.||-3.7|-14.0|
72602869|NCT04530838|144735098|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC (SC) is to the corresponding serotype in 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC SC - 13vPnC SC) was greater than -10%.|Percentage Difference|-3.2|||||TWO_SIDED|95.0|-6.8|-0.3||||||Serotype 7F: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.||-0.3|-6.8|
72602870|NCT04530838|144735098|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC (SC) is to the corresponding serotype in 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC SC - 13vPnC SC) was greater than -10%.|Percentage Difference|-2.7|||||TWO_SIDED|95.0|-6.4|0.4||||||Serotype 9V: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.||0.4|-6.4|
72602871|NCT04530838|144735098|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC (SC) is to the corresponding serotype in 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC SC - 13vPnC SC) was greater than -10%.|Percentage Difference|-0.9|||||TWO_SIDED|95.0|-4.4|2.4||||||Serotype 14: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.||2.4|-4.4|
72602872|NCT04530838|144735098|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC (SC) is to the corresponding serotype in 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC SC - 13vPnC SC) was greater than -10%.|Percentage Difference|-2.3|||||TWO_SIDED|95.0|-5.6|0.5||||||Serotype 18C: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.||0.5|-5.6|
72602873|NCT04530838|144735098|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC (SC) is to the corresponding serotype in 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC SC - 13vPnC SC) was greater than -10%.|Percentage Difference|0.0|||||TWO_SIDED|95.0|-2.1|2.1||||||Serotype 19A: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.||2.1|-2.1|
72602874|NCT04530838|144735098|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC (SC) is to the corresponding serotype in 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC SC - 13vPnC SC) was greater than -10%.|Percentage Difference|0.0|||||TWO_SIDED|95.0|-1.7|1.7||||||Serotype 19F: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.||1.7|-1.7|
72416241|NCT01972841|144343300|SUPERIORITY||Least squares mean difference|-1.59|STANDARD_ERROR_OF_MEAN|0.84||0.024|TWO_SIDED|95.0|-3.23|0.05|||Stratified rank ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the mirabegron 50 mg monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||0.05|-3.23|0.024
72602875|NCT04530838|144735098|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC (SC) is to the corresponding serotype in 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC SC - 13vPnC SC) was greater than -10%.|Percentage Difference|-4.0|||||TWO_SIDED|95.0|-9.5|1.2||||||Serotype 23F: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.||1.2|-9.5|
72602876|NCT04530838|144735098|NON_INFERIORITY|For the additional 7 serotypes, the compared results are from serotype 23F (13vPnC \[SC\] serotype with the lowest percentage, not including serotype 3) in the 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC SC - lowest 13vPnC SC) was greater than -10%.|Percentage Difference|5.9|||||TWO_SIDED|95.0|3.0|10.0||||||Serotype 8: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.||10.0|3.0|
72416242|NCT01972841|144343304|SUPERIORITY||Least squares mean difference|0.19|STANDARD_ERROR_OF_MEAN|0.29||0.52|TWO_SIDED|95.0|-0.39|0.76|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (solifenacin 5 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline mean number of micturitions per 24 hours as a covariate.||0.76|-0.39|0.520
72602877|NCT04530838|144735098|NON_INFERIORITY|For the additional 7 serotypes, the compared results are from serotype 23F (13vPnC \[SC\] serotype with the lowest percentage, not including serotype 3) in the 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC SC - lowest 13vPnC SC) was greater than -10%.|Percentage Difference|-33.5|||||TWO_SIDED|95.0|-40.7|-26.2||||||Serotype 10A: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.||-26.2|-40.7|
72602878|NCT04530838|144735098|NON_INFERIORITY|For the additional 7 serotypes, the compared results are from serotype 23F (13vPnC \[SC\] serotype with the lowest percentage, not including serotype 3) in the 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC SC - lowest 13vPnC SC) was greater than -10%.|Percentage Difference|6.4|||||TWO_SIDED|95.0|3.8|10.4||||||Serotype 11A: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.||10.4|3.8|
72602879|NCT04530838|144735098|NON_INFERIORITY|For the additional 7 serotypes, the compared results are from serotype 23F (13vPnC \[SC\] serotype with the lowest percentage, not including serotype 3) in the 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC SC - lowest 13vPnC SC) was greater than -10%.|Percentage Difference|-19.0|||||TWO_SIDED|95.0|-25.7|-12.5||||||Serotype 12F: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.||-12.5|-25.7|
72602880|NCT04530838|144735098|NON_INFERIORITY|For the additional 7 serotypes, the compared results are from serotype 23F (13vPnC \[SC\] serotype with the lowest percentage, not including serotype 3) in the 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC SC - lowest 13vPnC SC) was greater than -10%.|Percentage Difference|5.5|||||TWO_SIDED|95.0|2.2|9.6||||||Serotype 15B: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.||9.6|2.2|
72602881|NCT04530838|144735098|NON_INFERIORITY|For the additional 7 serotypes, the compared results are from serotype 23F (13vPnC \[SC\] serotype with the lowest percentage, not including serotype 3) in the 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC SC - lowest 13vPnC SC) was greater than -10%.|Percentage Difference|6.4|||||TWO_SIDED|95.0|3.8|10.4||||||Serotype 22F: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.||10.4|3.8|
72602882|NCT04530838|144735098|NON_INFERIORITY|For the additional 7 serotypes, the compared results are from serotype 23F (13vPnC \[SC\] serotype with the lowest percentage, not including serotype 3) in the 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC SC - lowest 13vPnC SC) was greater than -10%.|Percentage Difference|1.3|||||TWO_SIDED|95.0|-3.2|6.0||||||Serotype 33F: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.||6.0|-3.2|
72602883|NCT04530838|144735098|OTHER||Percentage Difference|-5.7|||||TWO_SIDED|95.0|-10.4|-1.7||||||Serotype 1: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.||-1.7|-10.4|
72602884|NCT04530838|144735098|OTHER||Percentage Difference|-1.1|||||TWO_SIDED|95.0|-5.2|2.9||||||Serotype 3: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.||2.9|-5.2|
72602885|NCT04530838|144735098|OTHER||Percentage Difference|-2.0|||||TWO_SIDED|95.0|-6.2|1.9||||||Serotype 4: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.||1.9|-6.2|
72602886|NCT04530838|144735098|OTHER||Percentage Difference|0.7|||||TWO_SIDED|95.0|-4.5|5.8||||||Serotype 5: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.||5.8|-4.5|
72602887|NCT04530838|144735098|OTHER||Percentage Difference|4.8|||||TWO_SIDED|95.0|-0.2|10.0||||||Serotype 6A: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.||10.0|-0.2|
72416243|NCT01972841|144343304|SUPERIORITY||Least squares mean difference|-0.24|STANDARD_ERROR_OF_MEAN|0.29||0.413|TWO_SIDED|95.0|-0.82|0.34|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (solifenacin 5 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline mean number of micturitions per 24 hours as a covariate.||0.34|-0.82|0.413
72602888|NCT04530838|144735098|OTHER||Percentage Difference|-5.6|||||TWO_SIDED|95.0|-12.5|1.1||||||Serotype 6B: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.||1.1|-12.5|
72602889|NCT04530838|144735098|OTHER||Percentage Difference|-1.1|||||TWO_SIDED|95.0|-5.4|3.1||||||Serotype 7F: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.||3.1|-5.4|
72602890|NCT04530838|144735098|OTHER||Percentage Difference|-3.0|||||TWO_SIDED|95.0|-7.7|1.4||||||Serotype 9V: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.||1.4|-7.7|
72602891|NCT04530838|144735098|OTHER||Percentage Difference|-0.6|||||TWO_SIDED|95.0|-4.4|3.2||||||Serotype 14: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.||3.2|-4.4|
72602892|NCT04530838|144735098|OTHER||Percentage Difference|-2.0|||||TWO_SIDED|95.0|-6.2|1.9||||||Serotype 18C: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.||1.9|-6.2|
72602893|NCT04530838|144735098|OTHER||Percentage Difference|-0.5|||||TWO_SIDED|95.0|-3.0|1.7||||||Serotype 19A: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.||1.7|-3.0|
72602894|NCT04530838|144735098|OTHER||Percentage Difference|0.0|||||TWO_SIDED|95.0|-1.8|1.7||||||Serotype 19F: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.||1.7|-1.8|
72602895|NCT04530838|144735098|OTHER||Percentage Difference|-0.9|||||TWO_SIDED|95.0|-6.9|5.1||||||Serotype 23F: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.||5.1|-6.9|
72602896|NCT04530838|144735098|OTHER||Percentage Difference|0.0|||||TWO_SIDED|95.0|-2.2|2.1||||||Serotype 8: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.||2.1|-2.2|
72602897|NCT04530838|144735098|OTHER||Percentage Difference|-0.6|||||TWO_SIDED|95.0|-9.8|8.6||||||Serotype 10A: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.||8.6|-9.8|
72602898|NCT04530838|144735098|OTHER||Percentage Difference|0.0|||||TWO_SIDED|95.0|-1.8|1.7||||||Serotype 11A: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.||1.7|-1.8|
72602899|NCT04530838|144735098|OTHER||Percentage Difference|0.0|||||TWO_SIDED|95.0|-8.2|8.2||||||Serotype 12F: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.||8.2|-8.2|
72602900|NCT04530838|144735098|OTHER||Percentage Difference|-0.5|||||TWO_SIDED|95.0|-3.3|2.0||||||Serotype 15B: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.||2.0|-3.3|
72602901|NCT04530838|144735098|OTHER||Percentage Difference|0.0|||||TWO_SIDED|95.0|-1.8|1.7||||||Serotype 22F: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.||1.7|-1.8|
72602902|NCT04530838|144735098|OTHER||Percentage Difference|-2.5|||||TWO_SIDED|95.0|-7.5|2.2||||||Serotype 33F: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.||2.2|-7.5|
72602903|NCT04530838|144735099|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC (SC) is to the corresponding serotype in 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC \[SC\]/13vPnC \[SC\]) was greater than 0.5 (2-fold criterion).|GMR|0.62|||||TWO_SIDED|95.0|0.54|0.72||||||Serotype 1: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.||0.72|0.54|
72602904|NCT04530838|144735099|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC (SC) is to the corresponding serotype in 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC \[SC\]/13vPnC \[SC\]) was greater than 0.5 (2-fold criterion).|GMR|0.71|||||TWO_SIDED|95.0|0.63|0.81||||||Serotype 3: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.||0.81|0.63|
72602905|NCT04530838|144735099|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC (SC) is to the corresponding serotype in 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC \[SC\]/13vPnC \[SC\]) was greater than 0.5 (2-fold criterion).|GMR|0.6|||||TWO_SIDED|95.0|0.51|0.7||||||Serotype 4: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.||0.70|0.51|
72602906|NCT04530838|144735099|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC (SC) is to the corresponding serotype in 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC \[SC\]/13vPnC \[SC\]) was greater than 0.5 (2-fold criterion).|GMR|0.59|||||TWO_SIDED|95.0|0.49|0.71||||||Serotype 5: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.||0.71|0.49|
72602907|NCT04530838|144735099|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC (SC) is to the corresponding serotype in 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC \[SC\]/13vPnC \[SC\]) was greater than 0.5 (2-fold criterion).|GMR|0.59|||||TWO_SIDED|95.0|0.5|0.7||||||Serotype 6A: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.||0.70|0.50|
72602908|NCT04530838|144735099|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC (SC) is to the corresponding serotype in 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC \[SC\]/13vPnC \[SC\]) was greater than 0.5 (2-fold criterion).|GMR|0.51|||||TWO_SIDED|95.0|0.4|0.64||||||Serotype 6B: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.||0.64|0.40|
72602909|NCT04530838|144735099|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC (SC) is to the corresponding serotype in 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC \[SC\]/13vPnC \[SC\]) was greater than 0.5 (2-fold criterion).|GMR|0.72|||||TWO_SIDED|95.0|0.62|0.84||||||Serotype 7F: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.||0.84|0.62|
72602910|NCT04530838|144735099|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC (SC) is to the corresponding serotype in 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC \[SC\]/13vPnC \[SC\]) was greater than 0.5 (2-fold criterion).|GMR|0.69|||||TWO_SIDED|95.0|0.6|0.8||||||Serotype 9V: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.||0.80|0.60|
72602911|NCT04530838|144735099|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC (SC) is to the corresponding serotype in 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC \[SC\]/13vPnC \[SC\]) was greater than 0.5 (2-fold criterion).|GMR|0.84|||||TWO_SIDED|95.0|0.7|1.01||||||Serotype 14: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.||1.01|0.70|
72602912|NCT04530838|144735099|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC (SC) is to the corresponding serotype in 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC \[SC\]/13vPnC \[SC\]) was greater than 0.5 (2-fold criterion).|GMR|0.66|||||TWO_SIDED|95.0|0.57|0.77||||||Serotype 18C: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.||0.77|0.57|
72602913|NCT04530838|144735099|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC (SC) is to the corresponding serotype in 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC \[SC\]/13vPnC \[SC\]) was greater than 0.5 (2-fold criterion).|GMR|0.76|||||TWO_SIDED|95.0|0.65|0.87||||||Serotype 19A: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.||0.87|0.65|
72602914|NCT04530838|144735099|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC (SC) is to the corresponding serotype in 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC \[SC\]/13vPnC \[SC\]) was greater than 0.5 (2-fold criterion).|GMR|0.75|||||TWO_SIDED|95.0|0.67|0.85||||||Serotype 19F: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.||0.85|0.67|
72602915|NCT04530838|144735099|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC (SC) is to the corresponding serotype in 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC \[SC\]/13vPnC \[SC\]) was greater than 0.5 (2-fold criterion).|GMR|0.64|||||TWO_SIDED|95.0|0.53|0.78||||||Serotype 23F: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.||0.78|0.53|
72602916|NCT04530838|144735099|NON_INFERIORITY|For the additional 7 serotypes, the compared results are from serotype 6B (13vPnC \[SC\] serotype with the lowest GMC, not including serotype 3) in the 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC \[SC\]/lowest 13vPnC \[SC\]) was greater than 0.5 (2-fold criterion).|GMR|4.01|||||TWO_SIDED|95.0|3.36|4.79||||||Serotype 8: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.||4.79|3.36|
72602917|NCT04530838|144735099|NON_INFERIORITY|For the additional 7 serotypes, the compared results are from serotype 6B (13vPnC \[SC\] serotype with the lowest GMC, not including serotype 3) in the 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC \[SC\]/lowest 13vPnC \[SC\]) was greater than 0.5 (2-fold criterion).|GMR|0.6|||||TWO_SIDED|95.0|0.48|0.76||||||Serotype 10A: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.||0.76|0.48|
72602918|NCT04530838|144735099|NON_INFERIORITY|For the additional 7 serotypes, the compared results are from serotype 6B (13vPnC \[SC\] serotype with the lowest GMC, not including serotype 3) in the 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC \[SC\]/lowest 13vPnC \[SC\]) was greater than 0.5 (2-fold criterion).|GMR|6.8|||||TWO_SIDED|95.0|5.69|8.13||||||Serotype 11A: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.||8.13|5.69|
72602919|NCT04530838|144735099|NON_INFERIORITY|For the additional 7 serotypes, the compared results are from serotype 6B (13vPnC \[SC\] serotype with the lowest GMC, not including serotype 3) in the 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC \[SC\]/lowest 13vPnC \[SC\]) was greater than 0.5 (2-fold criterion).|GMR|0.95|||||TWO_SIDED|95.0|0.76|1.2||||||Serotype 12F: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.||1.20|0.76|
72602920|NCT04530838|144735099|NON_INFERIORITY|For the additional 7 serotypes, the compared results are from serotype 6B (13vPnC \[SC\] serotype with the lowest GMC, not including serotype 3) in the 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC \[SC\]/lowest 13vPnC \[SC\]) was greater than 0.5 (2-fold criterion).|GMR|8.18|||||TWO_SIDED|95.0|6.75|9.92||||||Serotype 15B: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.||9.92|6.75|
72602921|NCT04530838|144735099|NON_INFERIORITY|For the additional 7 serotypes, the compared results are from serotype 6B (13vPnC \[SC\] serotype with the lowest GMC, not including serotype 3) in the 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC \[SC\]/lowest 13vPnC \[SC\]) was greater than 0.5 (2-fold criterion).|GMR|5.97|||||TWO_SIDED|95.0|5.0|7.12||||||Serotype 22F: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.||7.12|5.00|
72602922|NCT04530838|144735099|NON_INFERIORITY|For the additional 7 serotypes, the compared results are from serotype 6B (13vPnC \[SC\] serotype with the lowest GMC, not including serotype 3) in the 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC \[SC\]/lowest 13vPnC \[SC\]) was greater than 0.5 (2-fold criterion).|GMR|2.06|||||TWO_SIDED|95.0|1.69|2.51||||||Serotype 33F: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.||2.51|1.69|
72602923|NCT04530838|144735099|OTHER||GMR|0.85|||||TWO_SIDED|95.0|0.73|0.99||||||Serotype 1: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.||0.99|0.73|
72602924|NCT04530838|144735099|OTHER||GMR|0.85|||||TWO_SIDED|95.0|0.74|0.98||||||Serotype 3: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.||0.98|0.74|
72602925|NCT04530838|144735099|OTHER||GMR|0.98|||||TWO_SIDED|95.0|0.83|1.16||||||Serotype 4: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.||1.16|0.83|
72602926|NCT04530838|144735099|OTHER||GMR|0.98|||||TWO_SIDED|95.0|0.81|1.19||||||Serotype 5: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.||1.19|0.81|
72602927|NCT04530838|144735099|OTHER||GMR|1.19|||||TWO_SIDED|95.0|0.98|1.44||||||Serotype 6A: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.||1.44|0.98|
72602928|NCT04530838|144735099|OTHER||GMR|0.93|||||TWO_SIDED|95.0|0.72|1.21||||||Serotype 6B: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.||1.21|0.72|
72602929|NCT04530838|144735099|OTHER||GMR|0.96|||||TWO_SIDED|95.0|0.82|1.12||||||Serotype 7F: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.||1.12|0.82|
72602930|NCT04530838|144735099|OTHER||GMR|0.99|||||TWO_SIDED|95.0|0.85|1.16||||||Serotype 9V: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.||1.16|0.85|
72602931|NCT04530838|144735099|OTHER||GMR|0.87|||||TWO_SIDED|95.0|0.72|1.04||||||Serotype 14: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.||1.04|0.72|
72602932|NCT04530838|144735099|OTHER||GMR|0.92|||||TWO_SIDED|95.0|0.79|1.07||||||Serotype 18C: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.||1.07|0.79|
72602933|NCT04530838|144735099|OTHER||GMR|0.98|||||TWO_SIDED|95.0|0.84|1.13||||||Serotype 19A: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.||1.13|0.84|
72602934|NCT04530838|144735099|OTHER||GMR|0.98|||||TWO_SIDED|95.0|0.87|1.1||||||Serotype 19F: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.||1.10|0.87|
72602935|NCT04530838|144735099|OTHER||GMR|0.98|||||TWO_SIDED|95.0|0.81|1.19||||||Serotype 23F: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.||1.19|0.81|
72602936|NCT04530838|144735099|OTHER||GMR|0.99|||||TWO_SIDED|95.0|0.87|1.13||||||Serotype 8: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.||1.13|0.87|
72602937|NCT04530838|144735099|OTHER||GMR|0.94|||||TWO_SIDED|95.0|0.73|1.2||||||Serotype 10A: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.||1.20|0.73|
72602938|NCT04530838|144735099|OTHER||GMR|0.93|||||TWO_SIDED|95.0|0.81|1.06||||||Serotype 11A: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.||1.06|0.81|
72602939|NCT04530838|144735099|OTHER||GMR|0.91|||||TWO_SIDED|95.0|0.71|1.15||||||Serotype 12F: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.||1.15|0.71|
72602940|NCT04530838|144735099|OTHER||GMR|1.0|||||TWO_SIDED|95.0|0.85|1.18||||||Serotype 15B: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.||1.18|0.85|
72602941|NCT04530838|144735099|OTHER||GMR|0.89|||||TWO_SIDED|95.0|0.78|1.02||||||Serotype 22F: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.||1.02|0.78|
72602942|NCT04530838|144735099|OTHER||GMR|0.95|||||TWO_SIDED|95.0|0.79|1.15||||||Serotype 33F: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.||1.15|0.79|
72602943|NCT00803712|144735106|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||Hypothesis to be tested: the proportion of participants achieving the specified PTH target of ≥ 30% reduction in PTH from baseline will be greater in the cinacalcet plus low dose active vitamin D group than in the control group during the efficacy assessment phase at month 6 (weeks 22 to 26).||||<0.0001
72602944|NCT00803712|144735107|SUPERIORITY_OR_OTHER|||||||0.0002||||||Multiplicity adjusted p-value is presented, adjusted using the Dubey and Armitage-Parmer method|Cochran-Mantel-Haenszel|||||||0.0002
72602945|NCT00803712|144735108|SUPERIORITY_OR_OTHER|||||||0.0139||||||Adjusted p-value is presented. P-value is adjusted using Dubey and Armitage-Parmer method of adjusting for multiple comparisons|Cochran-Mantel-Haenszel|||||||0.0139
72602946|NCT00803712|144735109|SUPERIORITY_OR_OTHER|||||||0.2386||||||Multiplicity adjusted p-value is presented, adjusted using the Dubey and Armitage-Parmer method|Cochran-Mantel-Haenszel|||||||0.2386
72602947|NCT00803712|144735110|SUPERIORITY_OR_OTHER|||||||0.0875|||||||Cochran-Mantel-Haenszel|||||||0.0875
72602948|NCT00803712|144735111|SUPERIORITY_OR_OTHER|||||||0.4304|||||||Cochran-Mantel-Haenszel|||||||0.4304
72602949|NCT00803712|144735112|SUPERIORITY_OR_OTHER|||||||0.091|||||||Cochran-Mantel-Haenszel|||||||0.0910
72602950|NCT00803712|144735113|SUPERIORITY_OR_OTHER|||||||0.952|||||||Cochran-Mantel-Haenszel|||||||0.9520
72602951|NCT00803712|144735114|SUPERIORITY_OR_OTHER|||||||0.0003|||||||Cochran-Mantel-Haenszel|||||||0.0003
72602952|NCT00803712|144735115|SUPERIORITY_OR_OTHER|||||||0.0611|||||||Cochran-Mantel-Haenszel|||||||0.0611
72602953|NCT00803712|144735116|SUPERIORITY_OR_OTHER|||||||0.3298|||||||Cochran-Mantel-Haenszel|||||||0.3298
72602954|NCT00803712|144735117|SUPERIORITY_OR_OTHER|||||||0.4436|||||||Cochran-Mantel-Haenszel|||||||0.4436
72602955|NCT00803712|144735118|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|Analysis was adjusted for randomization strata. Due to distributional properties of the data, analysis was performed on log-transformed data||||||<0.0001
72602956|NCT00803712|144735119|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|Analysis was adjusted for randomization strata.||||||<0.0001
72602957|NCT00803712|144735120|SUPERIORITY_OR_OTHER|||||||0.004|||||||ANCOVA|Analysis was adjusted for randomization strata. Due to distributional properties of the data, analysis was performed on log-transformed data||||||0.0040
72602958|NCT00803712|144735121|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|Analysis was adjusted for randomization strata.||||||<0.0001
72602959|NCT00803712|144735122|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|Analysis was adjusted for randomization strata and baseline corrected serum calcium||||||<0.0001
72602960|NCT00803712|144735123|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|Analysis was adjusted for randomization strata and baseline corrected serum calcium.||||||<0.0001
72602961|NCT00803712|144735124|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|Analysis was adjusted for randomization strata and baseline corrected serum calcium.||||||<0.0001
72602962|NCT00803712|144735125|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|Analysis was adjusted for randomization strata and baseline corrected serum calcium.||||||<0.0001
72602963|NCT00803712|144735126|SUPERIORITY_OR_OTHER|||||||0.0085|||||||ANCOVA|Analysis was adjusted for randomization strata and baseline serum phosphorus.||||||0.0085
72602964|NCT00803712|144735127|SUPERIORITY_OR_OTHER|||||||0.071|||||||ANCOVA|Analysis was adjusted for randomization strata and baseline serum phosphorus.||||||0.0710
72602965|NCT00803712|144735128|SUPERIORITY_OR_OTHER|||||||0.3546|||||||ANCOVA|Analysis was adjusted for randomization strata and baseline serum phosphorus.||||||0.3546
72602966|NCT00803712|144735129|SUPERIORITY_OR_OTHER|||||||0.7518|||||||ANCOVA|Analysis was adjusted for randomization strata and baseline serum phosphorus.||||||0.7518
72602967|NCT02672176|144735137|EQUIVALENCE|Information included in Statistical Analysis||||||0.05|||||||Wilcoxon (Mann-Whitney)|||||||0.05
72602968|NCT02672176|144735138|EQUIVALENCE|See Statistical Analysis||||||0.05|||||||Wilcoxon (Mann-Whitney)|||||||0.05
72602969|NCT02672176|144735139|EQUIVALENCE|See Statistical Analysis||||||0.05|||||||Wilcoxon (Mann-Whitney)|||||||0.05
72602970|NCT02672176|144735140|EQUIVALENCE|See Statistical Analysis||||||0.05|||||||Wilcoxon (Mann-Whitney)|||||||0.05
72602971|NCT02672176|144735141|EQUIVALENCE|See Statistical Analysis||||||0.05|||||||Wilcoxon (Mann-Whitney)|||||||0.05
72602972|NCT02672176|144735142|EQUIVALENCE|See Statistical Analysis||||||0.05|||||||Wilcoxon (Mann-Whitney)|||||||0.05
72602973|NCT02672176|144735143|EQUIVALENCE|See Statistical Analysis||||||0.05|||||||Wilcoxon (Mann-Whitney)|||||||0.05
72602974|NCT02672176|144735144|EQUIVALENCE|Information in Statistical Analysis||||||0.05|||||||Wilcoxon (Mann-Whitney)|||||||0.05
72602975|NCT02672176|144735145|EQUIVALENCE|Information included in Statistical Analysis||||||0.05|||||||Wilcoxon (Mann-Whitney)|||||||0.05
72602976|NCT01677182|144735185|SUPERIORITY_OR_OTHER||Least Squares Mean Differences|0.8|STANDARD_ERROR_OF_MEAN|0.98||0.783|TWO_SIDED|97.5|-1.4|3.0||Mixed Model Repeated Measures (MMRM) model with baseline by week interaction, pooled center, week, treatment, baseline, and week by treatment interaction as factors was used for the analysis.|Mixed Model Repeated Measures|||||3.0|-1.4|0.783
72602977|NCT01677182|144735185|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.97||0.329|TWO_SIDED|97.5|-2.6|1.7||MMRM model with baseline by week interaction, pooled center, week, treatment, baseline, and week by treatment interaction as factors was used for the analysis.|Mixed Model Repeated Measures|||||1.7|-2.6|0.329
72602978|NCT01677182|144735186|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.5|STANDARD_ERROR_OF_MEAN|0.27||0.088|TWO_SIDED|97.5|-0.1|1.1||MMRM model with baseline by week interaction, pooled center, week, treatment, baseline, and week by treatment interaction as factors was used for the analysis.|Mixed Model Repeated Measures|||||1.1|-0.1|0.088
72602979|NCT01677182|144735186|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.27||0.642|TWO_SIDED|97.5|-0.7|0.5||MMRM model with baseline by week interaction, pooled center, week, treatment, baseline, and week by treatment interaction as factors was used for the analysis.|Mixed Model Repeated Measures|||||0.5|-0.7|0.642
72602980|NCT01677182|144735187|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.12||0.792|TWO_SIDED|97.5|-0.2|0.3||MMRM model with baseline by week interaction, pooled center, week, treatment, baseline, and week by treatment interaction as factors was used for the analysis.|Mixed Model Repeated Measures|||||0.3|-0.2|0.792
72416244|NCT01972841|144343304|SUPERIORITY||Least squares mean difference|-0.92|STANDARD_ERROR_OF_MEAN|0.29||0.002|TWO_SIDED|95.0|-1.5|-0.34|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (mirabegron 25 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline mean number of micturitions per 24 hours as a covariate.||-0.34|-1.50|0.002
72602981|NCT01677182|144735187|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.12||0.171|TWO_SIDED|97.5|-0.4|0.1||MMRM model with baseline by week interaction, pooled center, week, treatment, baseline, and week by treatment interaction as factors was used for the analysis.|Mixed Model Repeated Measures|||||0.1|-0.4|0.171
72602982|NCT01677182|144735188|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.12||0.653|TWO_SIDED|97.5|-0.2|0.3||MMRM model with baseline by week interaction, pooled center, week, treatment, baseline, and week by treatment interaction as factors was used for the analysis.|Mixed Model Repeated Measures|||||0.3|-0.2|0.653
72602983|NCT01677182|144735188|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.12||0.673|TWO_SIDED|97.5|-0.3|0.2||MMRM model with baseline by week interaction, pooled center, week, treatment, baseline, and week by treatment interaction as factors was used for the analysis.|Mixed Model Repeated Measures|||||0.2|-0.3|0.673
72602984|NCT01677182|144735189|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.8|STANDARD_ERROR_OF_MEAN|0.51||0.119|TWO_SIDED|97.5|-0.4|2.0||MMRM model with baseline by week interaction, pooled center, week, treatment, baseline, and week by treatment interaction as factors was used for the analysis.|Mixed Model Repeated Measures|||||2.0|-0.4|0.119
72602985|NCT01677182|144735189|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.51||0.791|TWO_SIDED|97.5|-1.3|1.0||MMRM model with baseline by week interaction, pooled center, week, treatment, baseline, and week by treatment interaction as factors was used for the analysis.|Mixed Model Repeated Measures|||||1.0|-1.3|0.791
72602986|NCT01677182|144735190|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.6|STANDARD_ERROR_OF_MEAN|0.7||0.422|TWO_SIDED|97.5|-1.0|2.1||MMRM model with baseline by week interaction, pooled center, week, treatment, baseline, and week by treatment interaction as factors was used for the analysis.|Mixed Model Repeated Measures|||||2.1|-1.0|0.422
72602987|NCT01677182|144735190|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|0.7||0.655|TWO_SIDED|97.5|-1.3|1.9||MMRM model with baseline by week interaction, pooled center, week, treatment, baseline, and week by treatment interaction as factors was used for the analysis.|Mixed Model Repeated Measures|||||1.9|-1.3|0.655
72602988|NCT01677182|144735191|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|1.64||0.696|TWO_SIDED|97.5|-4.5|2.8||MMRM model with baseline by week interaction, pooled center, week, treatment, baseline, and week by treatment interaction as factors was used for the analysis.|Mixed Model Repeated Measures|||||2.8|-4.5|0.696
72602989|NCT01677182|144735191|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|1.63||0.472|TWO_SIDED|97.5|-3.6|3.8||MMRM model with baseline by week interaction, pooled center, week, treatment, baseline, and week by treatment interaction as factors was used for the analysis.|Mixed Model Repeated Measures|||||3.8|-3.6|0.472
72602990|NCT01677182|144735192|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.998||||0.994|TWO_SIDED|95.0|0.651|1.53||Odds ratio, 95% confidence intervals and p-values are analyzed from logistic regression with explanatory variables for treatment and baseline MADRS total score.|Regression, Logistic|||||1.530|0.651|0.994
72602991|NCT01677182|144735192|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.886||||0.575|TWO_SIDED|95.0|0.58|1.352||Odds ratio, 95% confidence intervals and p-values are analyzed from logistic regression with explanatory variables for treatment and baseline MADRS total score.|Regression, Logistic|||||1.352|0.580|0.575
72602992|NCT01677182|144735193|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.978||||0.927|TWO_SIDED|95.0|0.606|1.577||Odds ratio, 95% confidence intervals and p-values are analyzed from logistic regression with explanatory variables for treatment and baseline MADRS total score.|Regression, Logistic|||||1.577|0.606|0.927
72602993|NCT01677182|144735193|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.865||||0.553|TWO_SIDED|95.0|0.536|1.397||Odds ratio, 95% confidence intervals and p-values are analyzed from logistic regression with explanatory variables for treatment and baseline MADRS total score.|Regression, Logistic|||||1.397|0.536|0.553
72602994|NCT00995722|144735195|NON_INFERIORITY_OR_EQUIVALENCE|N=80, (40 per group), 80% power to detect a group difference of 30%-35% and 5% significance level.|Mean Difference (Final Values)|-2.2||||0.37|TWO_SIDED|95.0|-7.2|2.8|||ANCOVA|ANCOVA used to compare mean values adjusting for the baseline value|QMG Score ranges from 0-15, where 0 is normal and a reduction in score represents imrovement.|Mean Ocular QMG Changes from Baseline to Week 16 . 95% CI and p-values obtained from the analysis of covariance model to adjust for the baseline value of the outcome variable.||2.8|-7.20|0.37
72602995|NCT00995722|144735196|NON_INFERIORITY_OR_EQUIVALENCE|Mean Change in quality of life as measured by the NEI-VFQ-25 at the end of Double- Blinded Treatment|Mean Difference (Net)|6.56||||0.13|TWO_SIDED|95.0|-2.59|15.71|||ANCOVA||Scores ranges fro 0-100 , where 100 is normal and an increase in score represents an improvement|Mean Change in quality of life as measured by the NEI-VFQ-25 at the end of Double- Blinded Treatment. 95% CI and p-values obtained from the analysis of covariance model to adjust for the baseline value of the outcome variable.||15.71|-2.59|0.13
72602996|NCT00995722|144735197|NON_INFERIORITY_OR_EQUIVALENCE|Mean Change in quality if life as measured by the MG-QOL-15 score at the end of Double- Blinded Treatment|Mean Difference (Final Values)|-3.81||||0.15|TWO_SIDED|95.0|-9.37|1.75|||ANCOVA||Ranges from 0-60, where 0 is Normal and a reduction in score represents improvement.|Mean Change in quality if life as measured by the MG-QOL-15 score at the end of Double- Blinded Treatment. 95% CI and p-values obtained from the analysis of covariance model to adjust for the baseline value of the outcome variable.||1.75|-9.37|0.15
72602997|NCT00995722|144735198|NON_INFERIORITY_OR_EQUIVALENCE|Mean Change NEI-VFQ-25 10 item neuro-opthtalmological supplement score baseline to week 16.|Mean Difference (Final Values)|16.98||||0.16|TWO_SIDED|95.0|-9.22|43.17|||ANCOVA||Ranges 0-100, where 100 is normal and an increase in score represents an improvement.|Mean Change NEI-VFQ-25 10 item neuro-opthtalmological supplement score baseline to week 16. 95% CI and p-values obtained from the analysis of covariance model to adjust for the baseline value of the outcome variable.||43.17|-9.22|0.16
72602998|NCT00762762|144735203|OTHER|||||||0.05|TWO_SIDED|95.0|||||ANOVA|||Means and standard deviations. 1 factor ANOVA to balance treatment groups to show no difference between groups. The null hypothesis states that there is no difference between groups.||||0.05
72602999|NCT00762762|144735204|OTHER|||||||0.05|TWO_SIDED|95.0|||||ANOVA|||Means and standard deviations. 1 factor ANOVA to balance treatment groups to show no difference between groups. The null hypothesis states that there is no difference between groups.||||0.05
72603000|NCT00762762|144735205|OTHER|||||||0.05|TWO_SIDED|95.0|||||ANOVA|||Means and standard deviations. 1 factor ANOVA to balance treatment groups to show no difference between groups. The null hypothesis states that there is no difference between groups.||||0.05
72603001|NCT00762762|144735206|OTHER|||||||0.05|TWO_SIDED|95.0|||||ANOVA|||Means and standard deviations. 1 factor ANOVA to balance treatment groups to show no difference between groups. The null hypothesis states that there is no difference between groups.||||0.05
72603002|NCT00762762|144735207|OTHER|||||||0.05|TWO_SIDED|95.0|||||ANOVA|||Means and standard deviations. 1 factor ANOVA to balance treatment groups to show no difference between groups. The null hypothesis states that there is no difference between groups.||||0.05
72603003|NCT00762762|144735208|SUPERIORITY_OR_OTHER_LEGACY|||||||0.05||95.0|||||ANOVA|||The null hypothesis states that there is no difference between groups.||||0.05
72603004|NCT00762762|144735209|SUPERIORITY_OR_OTHER_LEGACY|||||||0.05|TWO_SIDED|95.0|||||ANOVA|||The null hypothesis states that there is no difference between groups.||||0.05
72603005|NCT00762762|144735210|SUPERIORITY_OR_OTHER_LEGACY|||||||0.05||95.0|||||ANOVA|||The null hypothesis states that there is no difference between groups.||||0.05
72603006|NCT00762762|144735211|SUPERIORITY_OR_OTHER_LEGACY|||||||0.05||95.0|||||ANOVA|||The null hypothesis states that there is no difference between groups.||||0.05
72603007|NCT00762762|144735212|SUPERIORITY_OR_OTHER_LEGACY|||||||0.05||95.0|||||ANOVA|||The null hypothesis states that there is no difference between groups.||||0.05
72603008|NCT01563198|144735220|SUPERIORITY||||||<|0.0001|||||||Chi-squared|||Change in Non-completion Rate of MRI Scans From Baseline at Average of One Year (All Schedule Patients)||||<0.0001
72603009|NCT01563198|144735221|SUPERIORITY||||||<|0.0001|||||||Chi-squared|||||||<0.0001
72603010|NCT01563198|144735222|SUPERIORITY||||||<|0.0001|||||||Chi-squared|||||||<0.0001
72603011|NCT02781818|144735223|SUPERIORITY|||||||0.77|||||||Mixed Models Analysis|||||||0.77
72603012|NCT02781818|144735223|SUPERIORITY|||||||0.46|||||||Mixed Models Analysis|||||||0.46
72603013|NCT02781818|144735224|SUPERIORITY|||||||0.65|||||||Mixed Models Analysis|||||||.65
72603014|NCT02781818|144735224|SUPERIORITY|||||||0.98|||||||Mixed Models Analysis|||||||0.98
72603015|NCT02781818|144735225|SUPERIORITY|||||||0.5|||||||Mixed Models Analysis|||||||0.50
72603016|NCT02781818|144735225|SUPERIORITY|||||||0.7|||||||Mixed Models Analysis|||||||0.70
72603017|NCT00524771|144735226|NON_INFERIORITY_OR_EQUIVALENCE|Sample size calculations were based on a non-inferiority test of two exponential survival curves . These calculations are based on the following assumptions: 1) one-sided α of 0.025; 2) power (1-β) of 0.80; VTE incidence rate of 9.1 VTE/10.000 WY and 4) non-inferiority limit on hazard ratio of 2.|Hazard Ratio (HR)|0.9|||||TWO_SIDED|95.0|0.5|1.5|||||Hazard ratio was adjusted age, BMI, duration of current use and family history of VTE.|Tested null hypothesis: VTE hazard ratio for NuvaRing vs. COCs is higher or equal to 2. This analysis represents the a priori defined primary statistical analysis.||1.5|0.5|
72603018|NCT00524771|144735226|NON_INFERIORITY_OR_EQUIVALENCE|Sample size calculations were based on the primary statistical analysis (see above).|Hazard Ratio (HR)|0.8|||||TWO_SIDED|95.0|0.4|1.7|||||Hazard ratio was adjusted age, BMI, duration of current use and family history of VTE.|Tested null hypothesis: VTE hazard ratio for NuvaRing vs. COC2 is higher or equal to 2.||1.7|0.4|
72603019|NCT00524771|144735226|NON_INFERIORITY_OR_EQUIVALENCE|Sample size calculations were based on the primary statistical analysis (see above).|Hazard Ratio (HR)|0.8|||||TWO_SIDED|95.0|0.3|2.2|||||Hazard ratio was adjusted age, BMI, duration of current use and family history of VTE.|Like analysis 1 (see above) but restricted to exposure period of less than 6 months.||2.2|0.3|
72603020|NCT00524771|144735226|NON_INFERIORITY_OR_EQUIVALENCE|Sample size calculations were based on the primary statistical analysis (see above).|Hazard Ratio (HR)|0.9|||||TWO_SIDED|95.0|0.3|2.6|||||Hazard ratio was adjusted age, BMI, duration of current use and family history of VTE.|Like analysis 1 (see above) but restricted to exposure period of 6 - 12 months.||2.6|0.3|
72603021|NCT00524771|144735226|NON_INFERIORITY_OR_EQUIVALENCE|Sample size calculations were based on the primary statistical analysis (see above).|Hazard Ratio (HR)|0.8|||||TWO_SIDED|95.0|0.3|2.3|||||Hazard ratio was adjusted age, BMI, duration of current use and family history of VTE.|Like analysis 1 (see above) but restricted to exposure period of \> 12 months.||2.3|0.3|
72603022|NCT00524771|144735227|NON_INFERIORITY_OR_EQUIVALENCE|Sample size calculations were based on the primary statistical analysis (see above).|Hazard Ratio (HR)|0.7|||||TWO_SIDED|95.0|0.2|2.3|||||The hazard ratio was adjusted for age, BMI, Smoking, and treated hypertension.|||2.3|0.2|
72603023|NCT00524771|144735227|NON_INFERIORITY_OR_EQUIVALENCE|Sample size calculations were based on the primary statistical analysis (see above).|Hazard Ratio (HR)|0.8|||||TWO_SIDED|95.0|0.2|2.6|||||Hazard ratio was adjusted for age, BMI, smoking, and treated hypertension.|||2.6|0.2|
72603024|NCT00707057|144735234|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||The null versus alternative hypothesis regarding the analgesic efficacy using the SPID 8-12 was compared between the 2 treatment groups using an analysis of covariance (ANCOVA)model with each subject's outcome being his/her SPID 8-12 as the dependent variable in the ANCOVA model with terms for gender, treatment, and baseline pain score categories (stratified as ≤7 and \>7).||||<0.0001
72603025|NCT00707057|144735235|SUPERIORITY_OR_OTHER||||||<|0.0017||95.0|||||ANCOVA|||The null versus alternative hypothesis regarding the durability of analgesic efficacy using the PID scores at 24, 36, and 48 hours.An individual subject was to achieve the 2-point reduction at all 3 terminal time points in order to be defined as responder.||||<0.0017
72603026|NCT00707057|144735236|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Cochran-Mantel-Haenszel|||Time to confirmed first perceptible relief was defined as the time to first perceptible relief, provided that the subject also stopped the second stopwatch indicating meaningful relief. For those who failed to achieve confirmed first perceptible and/or meaningful relief, a censored time was assigned.||||<0.0001
72603027|NCT00707057|144735237|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Cochran-Mantel-Haenszel|||Time to confirmed first perceptible relief was defined as the time to first perceptible relief, provided that the subject also stopped the second stopwatch indicating meaningful relief. For those who failed to achieve confirmed first perceptible and/or meaningful relief, a censored time was assigned.||||<0.0001
72603028|NCT00707057|144735238|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Cochran-Mantel-Haenszel|||||||<0.0001
72603029|NCT00707057|144735239|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Cochran-Mantel-Haenszel|||||||<0.0001
72603030|NCT00707057|144735239|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Estimated Confidence Interval: 95%Method: Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel|||||||<0.0001
72603031|NCT00707057|144735240|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|With terms for treatment, gender, and baseline pain score categories stratified as ≤7 and \>7.||The PID at each time point prior to dose 2 was derived by substracting the pain intensity from the base line pain intensity, so that a higher value was indicative of a greater improvement. Time weighted SPID for each specified interval was derived by first multiplying each PID score by the time from the previous time point, and adding them together for each scheduled time point within the time interval. Time weighted TOTPAR for ech specified interval was similarly derived.||||<0.0001
72603032|NCT00707057|144735241|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Log Rank|||||||<0.0001
72603033|NCT00707057|144735242|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Cochran-Mantel-Haenszel|||The proportions of subjects who rescued at or prior to hour 8, hour 10, and hour 12 were reported and 95% confidence intervals for the corresponding parameters were calculated.||||<0.0001
72603034|NCT00707057|144735243|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||The pain relief and PID scores at individual time points were summarized by descriptive statistics. The test and reference were compared at each individual time point at 24, 36 and 48 hours.||||<0.0001
72603035|NCT00707057|144735244|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||P-value from ANCOVA with terms for treatment, gender and baseline pain score categories.|ANCOVA|||Global evaluation for dose 1, either at the time of rescue or at dose 2 whichever came first were summarized by descriptive statistics based on non-missing data. The range went from 0 (Very poor) to 10 (Excellent) units on an 11-point Pain Intensity Numerical Rating Scale (PI-NRS).||||<0.0001
72603036|NCT00707057|144735245|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||P- value from ANCOVA with terms for treatment, gender and baseline pain score categories.|ANCOVA|||"Global evaluation scores for dose 2 were summarized by descriptive statistics. Only non-missing values are used for the summary statistics.~The subjects were to provide global evaluation of dose 2 study medication using a range that went from 0 (Very poor) to 10 (Excellent) units on an 11-point Pain Intensity Numerical Rating Scale (PI-NRS)in response to pain relief."||||<0.0001
72603037|NCT00707057|144735245|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||P-value from ANCOVA with terms for treatment, gender and baseline pain scores categories.|ANCOVA|||"Maximum relief scores for dose 2 were summarized by descriptive statistics. Only non-missing values are used for the summary statistics.~The subjects were to provide maximum relief scores for dose 2 study medication on an 11-point pain intensity numerical rating scale (PI-NRS)in response to pain relief."||||<0.0001
72603038|NCT00707057|144735245|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||P-value from ANCOVA with terms for treatment, gender and baseline pain score categories.|ANCOVA|||"Overall relief scores for dose 2 were summarized by descriptive statistics. Only non-missing values are used for the summary statistics.~The subjects were to provide overall relief scores for dose 2 study medication on an 11-point pain intensity numerical rating scale (PI-NRS)in response to pain relief."||||<0.0001
72603039|NCT00707057|144735246|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||P-value from ANCOVA with terms for treatment, gender and baseline pain score categories.|ANCOVA|||Global evaluation scores for dose 3 were summarized by descriptive statistics. Only non-missing values are used for the summary statistics. The subjects were to provide global evaluation of dose 3 study medication using a range that went from 0 (Very poor) to 10 (Excellent) units on an 11-point Pain Intensity Numerical Rating Scale (PI-NRS)in response to pain relief.||||<0.0001
72603040|NCT00707057|144735246|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||P-value from ANCOVA with terms for treatment, gender and basee pain score categories.|ANCOVA|||Maximum relief scores for dose 3 were summarized by descriptive statistics. Only non-missing values are used for the summary statistics. The subjects were to provide maximum relief of dose 3 study medication on an 11-point pain intensity numerical rating scale (PI-NRS)in response to pain relief.||||<0.0001
72603041|NCT00707057|144735246|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||P-value from ANCOVA with terms for treatment, gender and baseline pain score categories.|ANCOVA|||Overall relief scores for dose 3 were summarized by descriptive statistics. Only non-missing values are used for the summary statistics. The subjects were to provide overall relief of dose 3 study medication on an 11-point pain intensity numerical rating scale (PI-NRS)in response to pain relief.||||<0.0001
72603042|NCT00707057|144735247|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||P-value from ANCOVA with terms for treatment, gender and baseline pain score categories.|ANCOVA|||Global evaluation scores for dose 4 were summarized by descriptive statistics. Only non-missing values are used for the summary statistics. The subjects were to provide global evaluation of dose 4 study medication using a range that went from 0 (Very poor) to 10 (Excellent) units on an 11-point Pain Intensity Numerical Rating Scale (PI-NRS)in response to pain relief.||||<0.0001
72416245|NCT01972841|144343304|SUPERIORITY||Least squares mean diffrence|-0.56|STANDARD_ERROR_OF_MEAN|0.3||0.06|TWO_SIDED|95.0|-1.13|0.02|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (mirabegron 50 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline mean number of micturitions per 24 hours as a covariate.||0.02|-1.13|0.060
72603043|NCT00707057|144735247|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||P-value from ANCOVA with terms for treatment, gender and baseline pain score categories.|ANCOVA|||Maximum relief scores for dose 4 were summarized by descriptive statistics. Only non-missing values are used for the summary statistics. The subjects were to provide maximum relief of dose 4 study medication on an 11-point pain intensity numerical rating scale (PI-NRS)in response to pain relief.||||<0.0001
72603044|NCT00707057|144735247|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||P-value from ANCOVA with terms for treatment, gender and baseline pain score categories.|ANCOVA|||Overall relief scores for dose 4 were summarized by descriptive statistics. Only non-missing values are used for the summary statistics. The subjects were to provide overall relief of dose 4 study medication on an 11-point pain intensity numerical rating scale (PI-NRS)in response to pain relief.||||<0.0001
72603045|NCT04611542|144735248|SUPERIORITY||Mean Difference (Final Values)|1.02|||<|0.001|TWO_SIDED||||||t-test, 2 sided|||||||<0.001
72603046|NCT04611542|144735249|SUPERIORITY||Median Difference (Final Values)|1.12|||<|0.001|TWO_SIDED||||||t-test, 2 sided|||||||<.001
72603047|NCT04611542|144735250|SUPERIORITY||Mean Difference (Final Values)|6.32|||<|0.001|TWO_SIDED||||||t-test, 2 sided||Investigators tested whether pretest to posttest change was significantly greater than 0 at P \< 0.05.|||||<0.001
72603048|NCT00320242|144735251|SUPERIORITY||Mean Difference (Final Values)|1.25|STANDARD_ERROR_OF_MEAN|0.48||0.0152|TWO_SIDED|95.0|0.26|2.23|||t-test, 2 sided|two-tailed paired t-test||||2.23|0.26|0.0152
72603049|NCT00320242|144735252|SUPERIORITY||Mean Difference (Final Values)|50.0|STANDARD_ERROR_OF_MEAN|11.7||0.005|TWO_SIDED|95.0|23.9|76.1|||t-test, 2 sided|||||76.1|23.9|0.005
72603050|NCT00320242|144735253|SUPERIORITY||Mean Difference (Net)|1.11|STANDARD_DEVIATION|1.31||0.02|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|two-tailed Wilcoxan signed-rank sum test||two-tailed Wilcoxan signed-rank sum test||||0.02
72603051|NCT00320242|144735254|OTHER|The percentage change in falls was analyzed using a two-tailed one-sample t-test with a hypothesized mean of 0||||||0.002||||||Two-tailed one-sample t-test with a hypothesized mean of 0. This analysis was not adjusted for multiple comparisons.|t-test, 2 sided|||The percentage change in falls was analyzed using a two-tailed one-sample t-test with a hypothesized mean of 0||||0.002
72603052|NCT00472732|144735255|SUPERIORITY_OR_OTHER|||||||0.003|TWO_SIDED|||||The Bonferroni-corrected a priori p-value was 0.007 (a priori alpha=0.05/number of tests=7).|t-test, 2 sided|||The null hypothesis predicted that the concentration of myoinositol in posterior cingulate gray matter will be the same in OTCD patients as in controls.||||0.003
72603053|NCT00472732|144735255|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||The Bonferroni-corrected a priori p-value was 0.007 (a priori alpha=0.05/number of tests=7).|t-test, 2 sided|||The null hypothesis predicted that the concentration of myoinositol in parietal white matter will be the same in OTCD patients as in controls.||||<0.001
72603054|NCT00472732|144735255|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED|||||The Bonferroni-corrected a priori p-value was 0.007 (a priori alpha=0.05/number of tests=7).|t-test, 2 sided|||The null hypothesis predicted that the concentration of glutamine in posterior cingulate gray matter would be the same for OTCD patients as for controls.||||0.001
72603055|NCT00472732|144735255|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||The Bonferroni-corrected a priori p-value was 0.007 (a priori alpha=0.05/number of tests=7).|t-test, 2 sided|||The null hypothesis predicted that the concentration of glutamine in parietal white matter would be the same for OTCD patients as for controls.||||<0.001
72603056|NCT00472732|144735256|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|||||This p-value is adjusted for family wise error rate correction.|t-test, 2 sided|||Two-way between-group t-tests restricted to the prefrontal cortex were performed to compare activation during for the 2-Back\> 1-Back contrast between OTCD patients and controls.||||<0.05
72603057|NCT00472732|144735257|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||t-test, 2 sided|||The null hypothesis predicted that fractional anisotropy, a marker of white matter integrity, would be the same for OTCD patients as for controls.||||<0.001
72603058|NCT02915159|144735258|SUPERIORITY|||||||0.4421|||||||longitudinal repeated measures analysis|||||||0.4421
72603059|NCT02915159|144735259|SUPERIORITY|||||||0.3367|||||||longitudinal repeated measures analysis|||||||0.3367
72603060|NCT02915159|144735260|SUPERIORITY|||||||0.5841|||||||longitudinal repeated measures analysis|||||||.5841
72603061|NCT02821416|144735302|SUPERIORITY||Median Difference (Final Values)|-5.81||||0.0208|TWO_SIDED|95.0|-10.69|-0.94|||Mixed Models Analysis|Model includes covariates of treatment, time post-allergen challenge , treatment\*time post-allergen challenge, allergen induced at screening||||-0.94|-10.69|0.0208
72603062|NCT02821416|144735303|SUPERIORITY||Median Difference (Final Values)|2.535||||0.363|TWO_SIDED|95.0|-3.045|8.116|||Mixed Models Analysis|Model includes covariates of treatment, maximum percent decrease in FEV1 late asthma response||||8.116|-3.045|0.3630
72603063|NCT01065571|144735304|EQUIVALENCE|Non-parametric analysis of interval to relapse||||||0.046||||||result from log rank test|Log Rank|||Kaplan-Meier life table analysis was performed to compare the two groups. The null hypothesis was that there would be no difference in relapses between the two groups during the study.||||0.046
72603064|NCT01065571|144735305|SUPERIORITY|fecal calprotectin (micrograms/gm stool)||||||0.06|||||||t-test, 2 sided|||||||0.06
72603065|NCT01065571|144735306|SUPERIORITY|||||||0.02||||||not adjusted for muliple comparisons, a priori threshold of 0.05|t-test, 2 sided|||paired t-test comparing baseline and value at end of participation||||0.02
72603066|NCT01001520|144735308|SUPERIORITY_OR_OTHER|||||||0.88||||||"Because the five a priori brain regions of interest (ROIs) are highly correlated, the significance threshold was adjusted to p=0.014."|Regression, Linear|BOLD signal change was examined using random effects maximum likelihood regression.||"We hypothesized that tolcapone would increase BOLD signal, meaning there would be an increase in brain activity, in the right dorsolateral prefrontal cortex, a part of the brain known to be involved in working memory.~We analyzed for main effects of treatment (tolcapone vs. placebo), back level (0, 1, 2, and 3), treatment order, and relevant covariates (genotype, race, age, sex, FTND score, Shipley IQ score)."||||0.88
72603067|NCT01001520|144735309|SUPERIORITY_OR_OTHER|||||||0.017||||||The threshold for statistical significance was not adjusted. Significance remained at p=0.05.|Regression, Linear|Accuracy was examined using random effects maximum likelihood regression.||We hypothesized that tolcapone (vs. placebo) would increase subject's accuracy during the N-back working memory task.||||0.017
72603068|NCT01001520|144735310|SUPERIORITY_OR_OTHER|||||||0.88||||||The threshold for statistical significance was not adjusted. Significance remained at p=0.05.|Regression, Linear|Examined using random effects maximum likelihood regression.||We hypothesized that tolcapone (vs. placebo) would reduce subject's reaction time during the N-back working memory task.||||0.88
72603069|NCT01001520|144735311|SUPERIORITY_OR_OTHER|||||||0.85||||||The threshold for statistical significance was not adjusted. Significance remained at p=0.05.|Regression, Linear|Examined using random effects maximum likelihood regression.||We hypothesized that smokers would smoke fewer cigarettes while taking tolcapone (vs. placebo).||||0.85
72603070|NCT01001520|144735312|SUPERIORITY_OR_OTHER|||||||0.4||||||The threshold for statistical significance was not adjusted. Significance remained at p=0.05.|Regression, Linear|Examined using random effects maximum likelihood regression.||We hypothesized that smokers, while taking tolcapone (vs. placebo), would experience less cigarette craving during their 24-hour abstinence period.||||0.40
72603071|NCT01001520|144735313|SUPERIORITY_OR_OTHER|||||||0.43||||||The threshold for statistical significance was not adjusted. Significance remained at p=0.05.|Regression, Linear|Examined using random effects maximum likelihood regression.||We hypothesized that smokers, while taking tolcapone (vs. placebo), would experience fewer withdrawal symptoms during their 24-hour abstinence period.||||0.43
72603072|NCT01001520|144735314|SUPERIORITY_OR_OTHER|||||||0.18||||||"Because the five a priori brain regions of interest (ROIs) are highly correlated, the significance threshold was adjusted to p=0.014."|Regression, Linear|BOLD signal change was examined using random effects maximum likelihood regression.||"We hypothesized that tolcapone would increase BOLD signal, meaning there would be an increase in brain activity, in the left dorsolateral prefrontal cortex, a part of the brain known to be involved in working memory.~We analyzed for main effects of treatment (tolcapone vs. placebo), back level (0, 1, 2, and 3), treatment order, and relevant covariates (genotype, race, age, sex, FTND score, Shipley IQ score)."||||0.18
72603073|NCT01001520|144735315|SUPERIORITY_OR_OTHER|||||||0.67||||||"Because the five a priori brain regions of interest (ROIs) are highly correlated, the significance threshold was adjusted to p=0.014."|Regression, Linear|BOLD signal change was examined using random effects maximum likelihood regression.||"We hypothesized that tolcapone would increase BOLD signal, meaning there would be an increase in brain activity, in the dorsal cingulate/medial prefrontal cortex, a part of the brain known to be involved in working memory.~We analyzed for main effects of treatment (tolcapone vs. placebo), back level (0, 1, 2, and 3), treatment order, and relevant covariates (genotype, race, age, sex, FTND score, Shipley IQ score)."||||0.67
72603074|NCT01001520|144735316|SUPERIORITY_OR_OTHER|||||||0.98||||||"Because the five a priori brain regions of interest (ROIs) are highly correlated, the significance threshold was adjusted to p=0.014."|Regression, Linear|BOLD signal change was examined using random effects maximum likelihood regression.||"We hypothesized that tolcapone would increase suppression of BOLD signal, meaning an increase in suppression of brain activity, in the posterior cingulate cortex, a part of the brain known to be involved in working memory.~We analyzed for main effects of treatment (tolcapone vs. placebo), back level (0, 1, 2, and 3), treatment order, and relevant covariates (genotype, race, age, sex, FTND score, Shipley IQ score)."||||0.98
72603075|NCT01001520|144735317|SUPERIORITY_OR_OTHER|||||||0.002||||||"Because the five a priori brain regions of interest (ROIs) are highly correlated, the significance threshold was adjusted to p=0.014."|Regression, Linear|BOLD signal change was examined using random effects maximum likelihood regression.||"We hypothesized that tolcapone would increase suppression of BOLD signal, meaning an increase in suppression of brain activity, in the ventromedial prefrontal cortex, a part of the brain known to be involved in working memory.~We analyzed for main effects of treatment (tolcapone vs. placebo), back level (0, 1, 2, and 3), treatment order, and relevant covariates (genotype, race, age, sex, FTND score, Shipley IQ score)."||||0.002
72603076|NCT02541422|144735318|SUPERIORITY|||||||0.45||||||p-value calculated for the total hangover scale|Wilcoxon (Mann-Whitney)|||||||0.45
72603077|NCT02541422|144735318|SUPERIORITY|||||||0.93||||||p value calculated for symptom of headache|Wilcoxon (Mann-Whitney)|||||||0.93
72603078|NCT02541422|144735318|SUPERIORITY|||||||0.11||||||p value calculated for symptom of nausea|Wilcoxon (Mann-Whitney)|||||||0.11
72603079|NCT02541422|144735318|SUPERIORITY|||||||0.72||||||p value calculated for symptom of weakness|Wilcoxon (Mann-Whitney)|||||||0.72
72603080|NCT01468454|144735341|OTHER||Specificity|89.5|||||TWO_SIDED|95.0|75.2|97.1||||||||97.1|75.2|
72603081|NCT01468454|144735341|OTHER||Sensitivity|83.9|||||TWO_SIDED|95.0|72.3|92.0||||||||92|72.3|
72603082|NCT00718094|144735385|SUPERIORITY|||||||0.03|||||||Fisher Exact|||||||0.03
72603083|NCT00705341|144735386|SUPERIORITY_OR_OTHER|||||||0.65||95.0|||||Regression, Linear|||Log-linear generalized estimating equation (GEE) models were used to assess the dose effect on PC20.||||0.65
72603084|NCT01720524|144735412|SUPERIORITY||Least square (LS) mean difference|0.0|STANDARD_ERROR_OF_MEAN|1.02||0.985|TWO_SIDED|95.0|-2.08|2.04|||ANCOVA|||||2.04|-2.08|0.9850
72603085|NCT01720524|144735413|SUPERIORITY||Difference in percentage|7.6||||0.4935|TWO_SIDED|95.0|-14.1|29.3|||Chi-squared|||||29.3|-14.1|0.4935
72603086|NCT01720524|144735414|SUPERIORITY|||||||0.9885|||||||Log Rank|||||||0.9885
72603087|NCT01720524|144735415|SUPERIORITY|||||||0.491|||||||Log Rank|||||||0.4910
72603088|NCT01720524|144735416|SUPERIORITY||Difference in Percentage|3.8||||0.7065|TWO_SIDED|95.0|-15.2|22.9|||Fisher Exact|||Additional Treatment||22.9|-15.2|0.7065
72603089|NCT01720524|144735416|SUPERIORITY||Difference in Percentage|0.3|||>|0.999|TWO_SIDED|95.0|-18.5|18.5|||Fisher Exact|||ECMO||18.5|-18.5|>0.999
72603090|NCT01720524|144735416|SUPERIORITY||Difference in Percentage|6.9||||0.2373|TWO_SIDED|95.0|-5.5|22.8|||Fisher Exact|||Death||22.8|-5.5|0.2373
72603091|NCT01720524|144735417|SUPERIORITY||LS Mean Difference|3.9||||0.4984|TWO_SIDED|95.0|-7.5|15.3|||ANCOVA|||Hour 6||15.3|-7.5|0.4984
72603092|NCT01720524|144735417|SUPERIORITY||LS Mean Difference|4.1||||0.3956|TWO_SIDED|95.0|-5.5|13.7|||ANCOVA|||Hour 12||13.7|-5.5|0.3956
72603093|NCT01720524|144735417|SUPERIORITY||LS Mean Difference|-2.2||||0.4249|TWO_SIDED|95.0|-7.6|3.3|||ANCOVA|||Hour 24||3.3|-7.6|0.4249
72603094|NCT01720524|144735418|SUPERIORITY||LS Mean Difference|0.7||||0.7686|TWO_SIDED|95.0|-4.3|5.8|||ANCOVA|||Hour 6||5.8|-4.3|0.7686
72603095|NCT01720524|144735418|SUPERIORITY||LS Mean Difference|-8.0||||0.1112|TWO_SIDED|95.0|-17.8|1.9|||ANCOVA|||Hour 12||1.9|-17.8|0.1112
72603096|NCT01720524|144735418|SUPERIORITY||LS Mean Difference|-8.2||||0.2089|TWO_SIDED|95.0|-21.2|4.8|||ANCOVA|||Hour 24||4.8|-21.2|0.2089
72603097|NCT01720524|144735419|SUPERIORITY||LS Mean Difference|37.2||||0.0829|TWO_SIDED|95.0|-5.0|79.5|||ANCOVA|||Hour 6||79.5|-5.0|0.0829
72603098|NCT01720524|144735419|SUPERIORITY||LS Mean Difference|26.6||||0.1802|TWO_SIDED|95.0|-12.7|65.9|||ANCOVA|||Hour 12||65.9|-12.7|0.1802
72603099|NCT01720524|144735419|SUPERIORITY||LS Mean Difference|79.9||||0.1576|TWO_SIDED|95.0|-32.5|192.2|||ANCOVA|||Hour 24||192.2|-32.5|0.1576
72603100|NCT00527826|144735453|NON_INFERIORITY_OR_EQUIVALENCE|Negative binomial model for the rate of exacerbations (per year) using the treatment duration as offset term and treatment, COPD severity (stratum) and interaction as fixed factors. This model took further into account a strata imbalance of 73% COPD III vs. 27% COPD IV according to the observed rates (SAS code: proc GENMOD).||||||0.73||95.0|||||Negative binomial model|Least square means adjusted for COPD severity (stratum), interaction of stratum with treatment, and strata imbalance of 73% COPD III vs. 27% COPD IV.||||||0.73
72603101|NCT00527826|144735455|NON_INFERIORITY_OR_EQUIVALENCE|Poisson model for the rate of exacerbations (per year) using the treatment duration as offset term and treatment, COPD severity (stratum) and interaction as fixed factors. This model took further into account a strata imbalance of 73% COPD III vs. 27% COPD IV according to the observed rates (SAS code: proc GENMOD).||||||0.66||95.0|||||Poisson model|Least square means adjusted for COPD severity (stratum), interaction of stratum with treatment, and strata imbalance of 73% COPD III vs. 27% COPD IV.||||||0.66
72603102|NCT02609984|144735487|OTHER||Hazard Ratio (HR)|0.8568||||0.49|TWO_SIDED|95.0|0.5507|1.333||P-value based on a 2-sided stratified log-rank test stratified by type of sarcoma: synovial sarcoma versus myxoid/round cell liposarcoma.|Log Rank||Hazard ratio is from Cox proportional hazards model stratified by type of sarcoma: synovial sarcoma versus myxoid/round cell liposarcoma.|||1.3330|0.5507|0.4900
72603103|NCT02609984|144735488|OTHER||Hazard Ratio (HR)|1.2145||||0.4737|TWO_SIDED|95.0|0.7131|2.0684||P-value based on a 2-sided stratified log-rank test stratified by type of sarcoma: synovial sarcoma versus myxoid/round cell liposarcoma.|Log Rank||Hazard ratio is from Cox proportional hazards model stratified by type of sarcoma: synovial sarcoma versus myxoid/round cell liposarcoma.|||2.0684|0.7131|0.4737
72416246|NCT01972841|144343305|SUPERIORITY||Rate ratio|0.85|STANDARD_ERROR_OF_MEAN|0.1||0.11|TWO_SIDED|95.0|0.7|1.04|||Negative binomial regression|||Rate ratio of number of urgency incontinence episodes during the 7-day diary bet. the given combination group \& the given monotherapy group calculated from a negative binomial regression model incl. treatment group, sex, age group (\<65,≥ 65 years), geographic region and previous OAB medication (yes, no) as factors, baseline log(number of urgency incontinence episodes used divided by number of valid diary days) included as a covariate \& postbaseline number of valid diary days as offset variable.||1.04|0.70|0.110
72603104|NCT02609984|144735492|OTHER|||||||0.3645||||||P-value based on a 2-sided stratified log-rank test stratified by type of sarcoma: synovial sarcoma versus myxoid/round cell liposarcoma.|Log Rank|||||||0.3645
72603105|NCT02609984|144735493|OTHER|||||||0.3466||||||P-value based on a 2-sided stratified log-rank test stratified by type of sarcoma: synovial sarcoma versus myxoid/round cell liposarcoma.|Log Rank|||||||0.3466
72603106|NCT02609984|144735494|OTHER||Hazard Ratio (HR)|0.7006||||0.1622|TWO_SIDED|95.0|0.4241|1.1574||P-value based on a 2-sided stratified log-rank test stratified by type of sarcoma: synovial sarcoma versus myxoid/round cell liposarcoma.|Log Rank||Hazard ratio is from Cox proportional hazards model stratified by type of sarcoma: synovial sarcoma versus myxoid/round cell liposarcoma.|||1.1574|0.4241|0.1622
72603107|NCT02609984|144735495|OTHER||Hazard Ratio (HR)|1.1849||||0.6397|TWO_SIDED|95.0|0.5817|2.4134||P-value based on a 2-sided stratified log-rank test stratified by type of sarcoma: synovial sarcoma versus myxoid/round cell liposarcoma.|Log Rank||Hazard ratio is from Cox proportional hazards model stratified by type of sarcoma: synovial sarcoma versus myxoid/round cell liposarcoma.|||2.4134|0.5817|0.6397
72603108|NCT02609984|144735496|OTHER|||||||0.1128|||||||exact Pearson chi-square test|||||||0.1128
72603109|NCT02609984|144735497|OTHER||||||<|0.0001|||||||exact Pearson chi-square test|||||||<0.0001
72603110|NCT02609984|144735498|OTHER|||||||0.405|||||||exact Pearson chi-square test|||||||0.4050
72603111|NCT02609984|144735499|OTHER|||||||0.0127|||||||exact Pearson chi-square test|||||||0.0127
72603112|NCT02504320|144735501|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence of Febuxostat formulation 1, 2, and 3 to Febuxostat formulation 4 was declared if the 90% confidence intervals for the ratios of central values were within the pre-specified interval of 0.80 to 1.25.|Point Estimate|1.0848|||||TWO_SIDED|90.0|0.9528|1.235|||||Point estimate and 90% CI were obtained from the exponentiated results of analysis of the natural log (ln)-transformed parameters was performed with regimen, sequence, period, and participants nested within sequence as fixed effects.|Relative bioavailability of a single dose of Febuxostat XR 80 mg in test (Regimen A) and reference (Regimen D).||1.2350|0.9528|
72603113|NCT02504320|144735501|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence of Febuxostat formulation 1, 2, and 3 to Febuxostat formulation 4 was declared if the 90% confidence intervals for the ratios of central values were within the pre-specified interval of 0.80 to 1.25.|Point Estimate|0.7709|||||TWO_SIDED|90.0|0.6767|0.8782|||||Point estimate and 90% CI were obtained from the exponentiated results of analysis of the natural log (ln)-transformed parameters was performed with regimen, sequence, period, and participants nested within sequence as fixed effects.|Relative bioavailability of a single dose of Febuxostat XR 80 mg in test (Regimen B) and reference (Regimen D).||0.8782|0.6767|
72603114|NCT02504320|144735501|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence of Febuxostat formulation 1, 2, and 3 to Febuxostat formulation 4 was declared if the 90% confidence intervals for the ratios of central values were within the pre-specified interval of 0.80 to 1.25.|Point Estimate|0.9389|||||TWO_SIDED|90.0|0.8246|1.0689|||||Point estimate and 90% CI were obtained from the exponentiated results of analysis of the natural log (ln)-transformed parameters was performed with regimen, sequence, period, and participants nested within sequence as fixed effects.|Relative bioavailability of a single dose of Febuxostat XR 80 mg in test (Regimen C) and reference (Regimen D).||1.0689|0.8246|
72603115|NCT02504320|144735502|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence of Febuxostat formulation 1, 2, and 3 to Febuxostat formulation 4 was declared if the 90% confidence intervals for the ratios of central values were within the pre-specified interval of 0.80 to 1.25.|Point Estimate|1.0435|||||TWO_SIDED|90.0|0.984|1.1066|||||Point estimate and 90% CI were obtained from the exponentiated results of analysis of the natural log (ln)-transformed parameters was performed with regimen, sequence, period, and participants nested within sequence as fixed effects.|Relative bioavailability of a single dose of Febuxostat XR 80 mg in test (Regimen A) and reference (Regimen D).||1.1066|0.9840|
72603116|NCT02504320|144735502|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence of Febuxostat formulation 1, 2, and 3 to Febuxostat formulation 4 was declared if the 90% confidence intervals for the ratios of central values were within the pre-specified interval of 0.80 to 1.25.|Point Estimate|0.8777|||||TWO_SIDED|90.0|0.8274|0.9311|||||Point estimate and 90% CI were obtained from the exponentiated results of analysis of the natural log (ln)-transformed parameters was performed with regimen, sequence, period, and participants nested within sequence as fixed effects.|Relative bioavailability of a single dose of Febuxostat XR 80 mg in test (Regimen B) and reference (Regimen D).||0.9311|0.8274|
72603117|NCT02504320|144735502|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence of Febuxostat formulation 1, 2, and 3 to Febuxostat formulation 4 was declared if the 90% confidence intervals for the ratios of central values were within the pre-specified interval of 0.80 to 1.25.|Point Estimate|0.954|||||TWO_SIDED|90.0|0.8996|1.0117|||||Point estimate and 90% CI were obtained from the exponentiated results of analysis of the natural log (ln)-transformed parameters was performed with regimen, sequence, period, and participants nested within sequence as fixed effects.|Relative bioavailability of a single dose of Febuxostat XR 80 mg in test (Regimen A) and reference (Regimen D).||1.0117|0.8996|
72603118|NCT02504320|144735503|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence of Febuxostat formulation 1, 2, and 3 to Febuxostat formulation 4 was declared if the 90% confidence intervals for the ratios of central values were within the pre-specified interval of 0.80 to 1.25.|Point Estimate|1.0283|||||TWO_SIDED|90.0|0.9691|1.0911|||||Point estimate and 90% CI were obtained from the exponentiated results of analysis of the natural log (ln)-transformed parameters was performed with regimen, sequence, period, and participants nested within sequence as fixed effects.|Relative bioavailability of a single dose of Febuxostat XR 80 mg in test (Regimen A) and reference (Regimen D).||1.0911|0.9691|
72603119|NCT02504320|144735503|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence of Febuxostat formulation 1, 2, and 3 to Febuxostat formulation 4 was declared if the 90% confidence intervals for the ratios of central values were within the pre-specified interval of 0.80 to 1.25.|Point Estimate|0.9056|||||TWO_SIDED|90.0|0.8516|0.963|||||Point estimate and 90% CI were obtained from the exponentiated results of analysis of the natural log (ln)-transformed parameters was performed with regimen, sequence, period, and participants nested within sequence as fixed effects.|Relative bioavailability of a single dose of Febuxostat XR 80 mg in test (Regimen B) and reference (Regimen D).||0.9630|0.8516|
72603120|NCT02504320|144735503|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence of Febuxostat formulation 1, 2, and 3 to Febuxostat formulation 4 was declared if the 90% confidence intervals for the ratios of central values were within the pre-specified interval of 0.80 to 1.25.|Point Estimates|0.9463|||||TWO_SIDED|90.0|0.8909|1.0051|||||Point estimate and 90% CI were obtained from the exponentiated results of analysis of the natural log (ln)-transformed parameters was performed with regimen, sequence, period, and participants nested within sequence as fixed effects.|Relative bioavailability of a single dose of Febuxostat XR 80 mg in test (Regimen C) and reference (Regimen D).||1.0051|0.8909|
72603121|NCT00941304|144735509|SUPERIORITY_OR_OTHER||LS Mean Difference|3.34||||0.4739|TWO_SIDED|95.0|-5.94|12.62|||ANCOVA|||||12.62|-5.94|.4739
72603122|NCT00941304|144735509|SUPERIORITY_OR_OTHER||LS Mean Difference|6.26||||0.2183|TWO_SIDED|95.0|-3.81|16.34|||ANCOVA|||||16.34|-3.81|.2183
72603123|NCT00941304|144735509|SUPERIORITY_OR_OTHER||LS Mean Difference|8.74||||0.0809|TWO_SIDED|95.0|-1.11|18.56|||ANCOVA|||||18.56|-1.11|.0809
72603124|NCT03293394|144735520|SUPERIORITY||||||=|0.001|||||||ANCOVA|||||||=0.001
72603125|NCT03293394|144735521|SUPERIORITY|||||||0.011|||||||ANOVA|||||||0.011
72603126|NCT03293394|144735522|SUPERIORITY|||||||0.19|||||||ANCOVA|||||||0.190
72603127|NCT03293394|144735523|SUPERIORITY|||||||0.652|||||||ANCOVA|||||||0.652
72603128|NCT03293394|144735524|SUPERIORITY|||||||0.19|||||||ANCOVA|||||||0.190
72603129|NCT03293394|144735525|SUPERIORITY|||||||0.011|||||||ANCOVA|||||||0.011
72603130|NCT03293394|144735526|SUPERIORITY|||||||0.003|||||||ANCOVA|||||||0.003
72603131|NCT03293394|144735527|SUPERIORITY|||||||0.001|||||||ANOVA|||||||0.001
72603132|NCT00086450|144735528|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|7.9||||0.005||95.0|3.3|12.5|||Regression, Cox|||||12.5|3.3|0.005
72603133|NCT00086450|144735529|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.74||||0.004||95.0|1.91|3.89|||Regression, Cox|||||3.89|1.91|0.004
72603134|NCT00086450|144735530|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|5.4||||0.049||95.0|||||Log Rank|||||||0.049
72603135|NCT00086450|144735531|SUPERIORITY_OR_OTHER|||||||0.68||95.0|||||Regression, Cox|||||||0.68
72603136|NCT01408901|144735555|SUPERIORITY||Mean Difference (Final Values)|28.7||||0.052|TWO_SIDED|95.0|5.1|52.3||The P value is a Hochberg-adjusted P value.|t-test, 2 sided|||||52.3|5.1|0.052
72603137|NCT01408901|144735555|SUPERIORITY||Mean Difference (Final Values)|-6.3||||0.91|TWO_SIDED|95.0|-30.2|17.6||The P value is a Hochberg-adjusted P value.|t-test, 2 sided|||||17.6|-30.2|0.91
72603138|NCT01408901|144735555|SUPERIORITY||Mean Difference (Final Values)|-1.4||||0.91|TWO_SIDED|95.0|-25.2|22.4||The P value is a Hochberg-adjusted P value.|t-test, 2 sided|||||22.4|-25.2|0.91
72603139|NCT01408901|144735555|SUPERIORITY||Mean Difference (Final Values)|33.6||||0.02|TWO_SIDED|95.0|9.4|57.7||The P value is a Hochberg-adjusted P value.|t-test, 2 sided|||||57.7|9.4|0.02
72603140|NCT01408901|144735556|SUPERIORITY||Hodges-Lehmann estimator|-0.61||||0.49|TWO_SIDED|95.0|-1.67|0.44||The P value is a Hochberg-adjusted P value.|Wilcoxon (Mann-Whitney)|||||0.44|-1.67|0.49
72603141|NCT01408901|144735556|SUPERIORITY||Hodges-Lehmann estimator|-0.67||||0.49|TWO_SIDED|95.0|-1.84|0.51||The P value is a Hochberg-adjusted P value.|Wilcoxon (Mann-Whitney)|||||0.51|-1.84|0.49
72603142|NCT01408901|144735556|SUPERIORITY||Hodges-Lehmann estimator|0.36||||0.49|TWO_SIDED|95.0|-0.66|1.38||The P value is a Hochberg-adjusted P value.|Wilcoxon (Mann-Whitney)|||||1.38|-0.66|0.49
72603143|NCT01408901|144735556|SUPERIORITY||Hodges-Lehmann estimator|0.48||||0.49|TWO_SIDED|95.0|-0.64|1.59||The P value is a Hochberg-adjusted P value.|Wilcoxon (Mann-Whitney)|||||1.59|-0.64|0.49
72603144|NCT01408901|144735557|SUPERIORITY||Mean Difference (Final Values)|3.6|||<|0.01|TWO_SIDED|95.0|2.1|5.0||The P value is a Hochberg-adjusted P value.|t-test, 2 sided|||||5.0|2.1|<0.01
72603145|NCT01408901|144735557|SUPERIORITY||Mean Difference (Final Values)|-0.7||||0.44|TWO_SIDED|95.0|-2.1|0.8||The P value is a Hochberg-adjusted P value.|t-test, 2 sided|||||0.8|-2.1|0.44
72603146|NCT01408901|144735557|SUPERIORITY||Mean Difference (Final Values)|-0.6||||0.44|TWO_SIDED|95.0|-2.1|0.9||The P value is a Hochberg-adjusted P value.|t-test, 2 sided|||||0.9|-2.1|0.44
72603147|NCT01408901|144735557|SUPERIORITY||Mean Difference (Final Values)|3.7|||<|0.01|TWO_SIDED|95.0|2.2|5.2||The P value is a Hochberg-adjusted P value.|t-test, 2 sided|||||5.2|2.2|<0.01
72603148|NCT01408901|144735558|SUPERIORITY||Mean Difference (Final Values)|-0.006||||0.09|TWO_SIDED|95.0|-0.012|0.001|||t-test, 2 sided|||||0.001|-0.012|0.09
72603149|NCT01408901|144735559|SUPERIORITY||Mean Difference (Final Values)|-0.005||||0.03|TWO_SIDED|95.0|-0.01|-0.001|||t-test, 2 sided|||||-0.001|-0.010|0.03
72603150|NCT01408901|144735560|SUPERIORITY||Mean Difference (Final Values)|-0.005||||0.09|TWO_SIDED|95.0|-0.012|0.001|||t-test, 2 sided|||||0.001|-0.012|0.09
72603151|NCT01408901|144735561|SUPERIORITY||Mean Difference (Final Values)|-0.004||||0.17|TWO_SIDED|95.0|-0.009|0.002|||t-test, 2 sided|||||0.002|-0.009|0.17
72603152|NCT04550364|144735565|OTHER|Semi-structured interview, background information, DSM 5 diagnosis and ED symptoms.||||||||||||||||23 of 24 women were used ideal type analysis as the methods. EDE-Q and DSM 5 diagnosis were measured.|Ideal type analysis as main method of analysis|||
72603153|NCT04550364|144735566|OTHER|Interpretative phenomenological analysis (IPA)||||||||||||||||of the 24 mothers there were 7 of them that had undergone In vitro fertilization. These women were interviewed twice and IPA were used in analysis the material.|IPA|||
72603154|NCT04550364|144735567|OTHER|Grounded theory was used analysis method. 5 distinct ED trajectories into motherhood were identified based on the womens experiences from pregnancy to postpartum.||||||||||||||||This study was based on interviews conducted with 24 participants during pregnancy and postpartum. Semi-structured interview with 24 women at two time points: 1. During pregnancy and 2. 4-6 months after birth. DSM 5 diagnosis at both time points were also assessed and symptoms at eating disorders through EDE-Q.|Qualitative methods using Ground theory|||
72603155|NCT01765569|144735588|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.82|||||TWO_SIDED|90.0|1.63|2.02||||||||2.02|1.63|
72603156|NCT01765569|144735592|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.47|||||TWO_SIDED|90.0|1.3|1.65||||||||1.65|1.3|
72603157|NCT05568797|144735618|NON_INFERIORITY|The non-inferiority is demonstrated if the upper limit (UL) of the 2-sided 95% confidence interval (CI) of the group GMT ratio (Control group divided by Co-Ad group) for HI antibody titers for the Flu strain is less than or equal (\<=) 1.5.|GMT Ratio|1.32|||||TWO_SIDED|0.95|1.13|1.53|||||The comparison was done using adjusted group ratio of GMT (ANCOVA model applied to the logarithm- transformed titers). The ANCOVA model included the treatment group and the age category as fixed effects and the pre-dose log-10 titer as covariate.|To demonstrate the non-inferiority of the FLU vaccine when co administered with the RSVPreF3 OA vaccine compared to the FLU vaccine administered alone, in terms of HI GMTs against the Flu A/Darwin/6/2021 H3N2 strain, at 1 month post-FLU vaccine dose administration (Day 31 for both groups).||1.53|1.13|
72603158|NCT05568797|144735618|NON_INFERIORITY|The non-inferiority is demonstrated if the UL of the 2-sided 95% CI of the group GMT ratio (Control group divided by Co-Ad group) for HI antibody titers for the Flu strain is \<=1.5.|GMT Ratio|1.04|||||TWO_SIDED|0.95|0.91|1.18|||||The comparison was done using adjusted group ratio of GMT (ANCOVA model applied to the logarithm- transformed titers). The ANCOVA model included the treatment group and the age category as fixed effects and the pre-dose log-10 titer as covariate.|To demonstrate the non-inferiority of the FLU vaccine when co administered with the RSVPreF3 OA vaccine compared to the FLU vaccine administered alone, in terms of HI GMTs against the Flu A/Victoria/2570/2019 H1N1 influenza strain included in the FLU vaccine, at 1 month post-FLU vaccine dose administration (Day 31 for both groups).||1.18|0.91|
72603159|NCT05568797|144735618|NON_INFERIORITY|The non-inferiority is demonstrated if the UL of the 2-sided 95% CI of the group GMT ratio (Control group divided by Co-Ad group) for HI antibody titers for the Flu strain is \<=1.5.|GMT Ratio|0.97|||||TWO_SIDED|0.95|0.9|1.06|||||The comparison was done using adjusted group ratio of GMT (ANCOVA model applied to the logarithm- transformed titers). The ANCOVA model included the treatment group and the age category as fixed effects and the pre-dose log-10 titer as covariate.|To demonstrate the non-inferiority of the FLU vaccine when co administered with the RSVPreF3 OA vaccine compared to the FLU vaccine administered alone, in terms of HI GMTs against the Flu B/Austria/1359417/2021 influenza strain included in the FLU vaccine, at 1 month post-FLU vaccine dose administration (Day 31 for both groups).||1.06|0.90|
72603160|NCT05568797|144735618|NON_INFERIORITY|The non-inferiority is demonstrated if the UL of the 2-sided 95% CI of the group GMT ratio (Control group divided by Co-Ad group) for HI antibody titers for the Flu strain is \<=1.5.|GMT Ratio|1.04|||||TWO_SIDED|0.95|0.95|1.13|||||The comparison was done using adjusted group ratio of GMT (ANCOVA model applied to the logarithm- transformed titers). The ANCOVA model included the treatment group and the age category as fixed effects and the pre-dose log-10 titer as covariate.|To demonstrate the non-inferiority of the FLU vaccine when co administered with the RSVPreF3 OA vaccine compared to the Flu vaccine administered alone, in terms of HI GMTs against the Flu B/Phuket/3073/2013 Yamagata influenza strain included in the FLU vaccine, at 1 month post-FLU vaccine dose administration (Day 31 for both groups).||1.13|0.95|
72603161|NCT05568797|144735619|NON_INFERIORITY|The non-inferiority is demonstrated if the UL of the 2-sided 95% CI of the GMT ratio (Control group divided by Co-Ad group) for RSV-A neutralizing antibody vaccine is \<=1.5.|GMT Ratio|0.99|||||TWO_SIDED|0.95|0.87|1.12|||||The comparison is done using adjusted group ratio of GMT (ANCOVA model applied to the logarithm- transformed titers). The ANCOVA model included the treatment group and the age category as fixed effects and the pre-dose log-10 titer as covariate.|To demonstrate the non-inferiority of the RSVPreF3 OA vaccine when co-administered with the FLU vaccine compared to the RSVPreF3 OA vaccine administered alone, in terms of RSV-A neutralizing antibody titers, at 1 month after the RSVPreF3 OA vaccine dose (Day 31 for the Co-Ad Group and Day 61 for the Control Group).||1.12|0.87|
72603162|NCT05568797|144735620|NON_INFERIORITY|The non-inferiority is demonstrated if the UL of the 2-sided 95% CI of the GMT ratio (Control group divided by Co-Ad group) for RSV-B neutralizing antibody vaccine is \<=1.5.|GMT Ratio|1.16|||||TWO_SIDED|0.95|1.03|1.3|||||The comparison is done using adjusted group ratio of GMT (ANCOVA model applied to the logarithm- transformed titers). The ANCOVA model included the treatment group, the age category as fixed effects and the pre-dose log-10 titer as covariate.|To demonstrate the non-inferiority of the RSVPreF3 OA vaccine when co-administered with the FLU vaccine compared to the RSVPreF3 OA vaccine administered alone, in terms of RSV-B neutralizing antibody titers, at 1 month after the RSVPreF3 OA vaccine dose (Day 31 for the CoAd Group and Day 61 for the Control Group).||1.30|1.03|
72603163|NCT05568797|144735621|NON_INFERIORITY|The non-inferiority is demonstrated if the UL of the 2-sided 95% CI on the group difference (Control group minus Co-Ad group) in terms of SCR is \<=10% for anti-HI antibodies.|Difference of Percentage|10.25|||||TWO_SIDED|0.95|3.5|16.9||||||To evaluate the non-inferiority of the FLU vaccine when co-administered with the RSVPreF3 OA vaccine compared to the FLU vaccine administered alone as measured by the difference of percentage of participants achieving seroconversion for HI antibody titers against Flu A/Darwin/6/2021 H3N2 strain at 1 month post-FLU vaccine dose administration (Day 31 for both groups).||16.90|3.50|
72603164|NCT05568797|144735621|NON_INFERIORITY|The non-inferiority is demonstrated if the UL of the 2-sided 95% CI on the group difference (Control group minus Co-Ad group) in terms of SCR is \<=10% for anti-HI antibodies.|Difference of Percentage|1.66|||||TWO_SIDED|0.95|-5.16|8.47||||||To evaluate the non-inferiority of the FLU vaccine when co-administered with the RSVPreF3 OA vaccine compared to the FLU vaccine administered alone as measured by the difference of percentage of participants achieving seroconversion for HI antibody titers against Flu A/Victoria/2570/2019 H1N1 strain at 1 month post-FLU vaccine dose administration (Day 31 for both groups).||8.47|-5.16|
72416247|NCT01972841|144343305|SUPERIORITY||Rate ratio|0.9|STANDARD_ERROR_OF_MEAN|0.1||0.288|TWO_SIDED|95.0|0.73|1.1|||Negative binomial regression|||Rate ratio of number of urgency incontinence episodes during the 7-day diary bet. the given combination group \& the given monotherapy group calculated from a negative binomial regression model incl. treatment group, sex, age group (\<65,≥ 65 years), geographic region and previous OAB medication (yes, no) as factors, baseline log(number of urgency incontinence episodes used divided by number of valid diary days) included as a covariate \& postbaseline number of valid diary days as offset variable.||1.10|0.73|0.288
72603165|NCT05568797|144735621|NON_INFERIORITY|The non-inferiority is demonstrated if the UL of the 2-sided 95% CI on the group difference (Control group minus Co-Ad group) in terms of SCR is \<=10% for anti-HI antibodies.|Difference of Percentage|0.25|||||TWO_SIDED|0.95|-4.92|5.46||||||To evaluate the non-inferiority of the FLU vaccine when co-administered with the RSVPreF3 OA vaccine compared to the FLU vaccine administered alone as measured by the difference of percentage of participants achieving seroconversion for HI antibody titers against Flu B/Austria/1359417/2021 Victoria at 1 month post-FLU vaccine dose administration (Day 31 for both groups).||5.46|-4.92|
72603166|NCT05568797|144735621|NON_INFERIORITY|The non-inferiority is demonstrated if the UL of the 2-sided 95% CI on the group difference (Control group minus Co-Ad group) in terms of SCR is \<=10% for anti-HI antibodies.|Difference of Percentage|0.79|||||TWO_SIDED|0.95|-4.54|6.17||||||To evaluate the non-inferiority of the FLU vaccine when co-administered with the RSVPreF3 OA vaccine compared to the FLU vaccine administered alone as measured by the difference of percentage of participants achieving seroconversion for HI antibody titers against Flu B/Phuket/3073/2013 Yamagata strain at 1 month post-FLU vaccine dose administration (Day 31 for both groups).||6.17|-4.54|
72603167|NCT03131687|144735634|OTHER||Posterior Mean Difference|-1.0|STANDARD_DEVIATION|0.17|||TWO_SIDED||||||||Statistics are estimated from a Bayesian hierarchical logistic dose response model along with a titrated integrated two-component prediction model to estimate missing values.|||||
72603168|NCT03131687|144735634|OTHER||Posterior Mean Difference|-1.67|STANDARD_DEVIATION|0.17|||TWO_SIDED||||||||Statistics are estimated from a Bayesian hierarchical logistic dose response model along with a titrated integrated two-component prediction model to estimate missing values.|||||
72603169|NCT03131687|144735634|OTHER||Posterior Mean Difference|-1.83|STANDARD_DEVIATION|0.17|||TWO_SIDED||||||||Statistics are estimated from a Bayesian hierarchical logistic dose response model along with a titrated integrated two-component prediction model to estimate missing values.|||||
72603170|NCT03131687|144735634|OTHER||Posterior Mean Difference|-1.89|STANDARD_DEVIATION|0.17|||TWO_SIDED||||||||Statistics are estimated from a Bayesian hierarchical logistic dose response model along with a titrated integrated two-component prediction model to estimate missing values.|||||
72603171|NCT03131687|144735635|OTHER||Posterior Mean Difference|-0.89|STANDARD_DEVIATION|0.15|||TWO_SIDED||||||||Statistics are estimated from a Bayesian hierarchical logistic dose response model along with a titrated integrated two-component prediction model to estimate missing values.|||||
72603172|NCT03131687|144735635|OTHER||Posterior Mean Difference|-1.49|STANDARD_DEVIATION|0.15|||TWO_SIDED||||||||Statistics are estimated from a Bayesian hierarchical logistic dose response model along with a titrated integrated two-component prediction model to estimate missing values.|||||
72603173|NCT03131687|144735635|OTHER||Posterior Mean Difference|-1.62|STANDARD_DEVIATION|0.15|||TWO_SIDED||||||||Statistics are estimated from a Bayesian hierarchical logistic dose response model along with a titrated integrated two-component prediction model to estimate missing values.|||||
72603174|NCT03131687|144735635|OTHER||Posterior Mean Difference|-1.67|STANDARD_DEVIATION|0.15|||TWO_SIDED||||||||Statistics are estimated from a Bayesian hierarchical logistic dose response model along with a titrated integrated two-component prediction model to estimate missing values.|||||
72603175|NCT03131687|144735636|OTHER||Mean Difference (Final Values)|-0.8|||<|0.001|TWO_SIDED|95.0|-1.2|-0.4|||Mixed Models Analysis|||||-0.4|-1.2|<0.001
72603176|NCT03131687|144735636|OTHER||Median Difference (Final Values)|-1.7|||<|0.001|TWO_SIDED|95.0|-2.2|-1.3|||Mixed Models Analysis|||||-1.3|-2.2|<0.001
72603177|NCT03131687|144735636|OTHER||Median Difference (Final Values)|-2.1|||<|0.001|TWO_SIDED|95.0|-2.5|-1.6|||Mixed Models Analysis|||||-1.6|-2.5|<0.001
72603178|NCT03131687|144735636|OTHER||Median Difference (Final Values)|-2.5|||<|0.001|TWO_SIDED|95.0|-2.9|-2.0|||Mixed Models Analysis|||||-2.0|-2.9|<0.001
72603179|NCT03131687|144735637|OTHER||Mean Difference (Final Values)|-0.8|||<|0.001|TWO_SIDED|95.0|-1.1|-0.4|||Mixed Models Analysis|||||-0.4|-1.1|<0.001
72603180|NCT03131687|144735637|OTHER||Mean Difference (Final Values)|-1.7|||<|0.001|TWO_SIDED|95.0|-2.0|-1.3|||Mixed Models Analysis|||||-1.3|-2.0|<0.001
72603181|NCT03131687|144735637|OTHER||Mean Difference (Final Values)|-1.9|||<|0.001|TWO_SIDED|95.0|-2.3|-1.5|||Mixed Models Analysis|||||-1.5|-2.3|<0.001
72603182|NCT03131687|144735637|OTHER||Mean Difference (Final Values)|-2.1|||<|0.001|TWO_SIDED|95.0|-2.4|-1.7|||Mixed Models Analysis|||||-1.7|-2.4|<0.001
72603183|NCT03131687|144735638|OTHER||Mean Difference (Final Values)|-0.5||||0.655|TWO_SIDED|95.0|-2.7|1.7|||Mixed Models Analysis|||||1.7|-2.7|0.655
72603184|NCT03131687|144735638|OTHER||Mean Difference (Final Values)|-4.4|||<|0.001|TWO_SIDED|95.0|-6.6|-2.3|||Mixed Models Analysis|||||-2.3|-6.6|<0.001
72603185|NCT03131687|144735638|OTHER||Mean Difference (Final Values)|-8.3|||<|0.001|TWO_SIDED|95.0|-10.5|-6.0|||Mixed Models Analysis|||||-6.0|-10.5|<0.001
72603186|NCT03131687|144735638|OTHER||Median Difference (Final Values)|-10.9|||<|0.001|TWO_SIDED|95.0|-13.3|-8.6|||Mixed Models Analysis|||||-8.6|-13.3|<0.001
72603187|NCT03131687|144735639|OTHER|||||||0.053|||||||Regression, Logistic|||||||0.053
72603188|NCT03131687|144735639|OTHER|||||||0.002|||||||Regression, Logistic|||||||0.002
72603189|NCT03131687|144735639|OTHER||||||<|0.001|||||||Regression, Logistic|||||||<0.001
72603190|NCT03131687|144735639|OTHER||||||<|0.001|||||||Regression, Logistic|||||||<0.001
72603191|NCT03131687|144735640|OTHER|||||||0.193|||||||Regression, Logistic|||||||0.193
72603192|NCT03131687|144735640|OTHER|||||||0.036|||||||Regression, Logistic|||||||0.036
72603193|NCT03131687|144735640|OTHER|||||||0.003|||||||Regression, Logistic|||||||0.003
72603194|NCT03131687|144735640|OTHER|||||||0.003|||||||Regression, Logistic|||||||0.003
72603195|NCT03131687|144735641|OTHER|||||||0.03|||||||Regression, Logistic|||||||0.030
72603196|NCT03131687|144735641|OTHER||||||<|0.001|||||||Regression, Logistic|||||||<0.001
72603197|NCT03131687|144735641|OTHER||||||<|0.001|||||||Regression, Logistic|||||||<0.001
72603198|NCT03131687|144735641|OTHER||||||<|0.001|||||||Regression, Logistic|||||||<0.001
72603199|NCT03131687|144735642|OTHER|||||||0.008|||||||Regression, Logistic|||||||0.008
72603200|NCT03131687|144735642|OTHER||||||<|0.001|||||||Regression, Logistic|||||||<0.001
72603201|NCT03131687|144735642|OTHER||||||<|0.001|||||||Regression, Logistic|||||||<0.001
72603202|NCT03131687|144735642|OTHER||||||<|0.001|||||||Regression, Logistic|||||||<0.001
72603203|NCT03131687|144735643|OTHER||Mean Difference (Final Values)|-22.4||||0.01|TWO_SIDED|95.0|-39.4|-5.3|||Mixed Models Analysis|||||-5.3|-39.4|0.010
72603204|NCT03131687|144735643|OTHER||Mean Difference (Final Values)|-56.2|||<|0.001|TWO_SIDED|95.0|-72.9|-39.5|||Mixed Models Analysis|||||-39.5|-72.9|<0.001
72603205|NCT03131687|144735643|OTHER||Odds Ratio (OR)|-76.3|||<|0.001|TWO_SIDED|95.0|-93.3|-59.2|||Mixed Models Analysis|||||-59.2|-93.3|<0.001
72603206|NCT03131687|144735643|OTHER||Mean Difference (Final Values)|-73.0|||<|0.001|TWO_SIDED|95.0|-90.9|-55.2|||Mixed Models Analysis|||||-55.2|-90.9|<0.001
72603207|NCT03131687|144735644|OTHER||Mean Difference (Final Values)|0.0||||0.396|TWO_SIDED|95.0|-0.1|0.0|||Mixed Models Analysis|||||0.0|-0.1|0.396
72603208|NCT03131687|144735644|OTHER||Mean Difference (Final Values)|0.0||||0.903|TWO_SIDED|95.0|-0.1|0.1|||Mixed Models Analysis|||||0.1|-0.1|0.903
72603209|NCT03131687|144735644|OTHER||Mean Difference (Final Values)|0.0||||0.536|TWO_SIDED|95.0|-0.1|0.1|||Mixed Models Analysis|||||0.1|-0.1|0.536
72603210|NCT03131687|144735644|OTHER||Mean Difference (Final Values)|0.0||||0.325|TWO_SIDED|95.0|0.0|0.1|||Mixed Models Analysis|||||0.1|-0.0|0.325
72603211|NCT03131687|144735645|OTHER||Mean Difference (Final Values)|-0.1||||0.565|TWO_SIDED|95.0|-0.4|0.2|||Mixed Models Analysis|||||0.2|-0.4|0.565
72603212|NCT03131687|144735645|OTHER||Mean Difference (Final Values)|-0.4||||0.01|TWO_SIDED|95.0|-0.7|-0.1|||Mixed Models Analysis|||||-0.1|-0.7|0.010
72603213|NCT03131687|144735645|OTHER||Median Difference (Final Values)|-0.5||||0.001|TWO_SIDED|95.0|-0.9|-0.2|||Mixed Models Analysis|||||-0.2|-0.9|0.001
72603214|NCT03131687|144735645|OTHER||Median Difference (Final Values)|-0.6|||<|0.001|TWO_SIDED|95.0|-0.9|-0.3|||Mixed Models Analysis|||||-0.3|-0.9|<0.001
72603215|NCT03131687|144735646|OTHER||Mean Difference (Final Values)|-0.3||||0.164|TWO_SIDED|95.0|-0.7|0.1|||Mixed Models Analysis|||||0.1|-0.7|0.164
72603216|NCT03131687|144735646|OTHER||Mean Difference (Final Values)|-0.8|||<|0.001|TWO_SIDED|95.0|-1.1|-0.4|||Mixed Models Analysis|||||-0.4|-1.1|<0.001
72603217|NCT03131687|144735646|OTHER||Mean Difference (Final Values)|-1.0|||<|0.001|TWO_SIDED|95.0|-1.4|-0.6|||Mixed Models Analysis|||||-0.6|-1.4|<0.001
72603218|NCT03131687|144735646|OTHER||Median Difference (Final Values)|-1.1|||<|0.001|TWO_SIDED|95.0|-1.5|-0.7|||Mixed Models Analysis|||||-0.7|-1.5|<0.001
72603219|NCT03131687|144735647|OTHER||Mean Difference (Final Values)|0.0||||0.919|TWO_SIDED|95.0|-0.3|0.3|||Mixed Models Analysis|||||0.3|-0.3|0.919
72603220|NCT03131687|144735647|OTHER||Mean Difference (Final Values)|-0.2||||0.194|TWO_SIDED|95.0|-0.5|0.1|||Mixed Models Analysis|||||0.1|-0.5|0.194
72603221|NCT03131687|144735647|OTHER||Mean Difference (Final Values)|-0.2||||0.145|TWO_SIDED|95.0|-0.5|0.1|||Mixed Models Analysis|||||0.1|-0.5|0.145
72603222|NCT03131687|144735647|OTHER||Mean Difference (Final Values)|-0.3||||0.067|TWO_SIDED|95.0|-0.6|0.0|||Mixed Models Analysis|||||0.0|-0.6|0.067
72603223|NCT03131687|144735648|OTHER||Mean Difference (Final Values)|-0.7||||0.539|TWO_SIDED|95.0|-3.1|1.6|||Mixed Models Analysis|||||1.6|-3.1|0.539
72603224|NCT03131687|144735648|OTHER||Mean Difference (Final Values)|-3.8||||0.001|TWO_SIDED|95.0|-6.1|-1.5|||Mixed Models Analysis|||||-1.5|-6.1|0.001
72603225|NCT03131687|144735648|OTHER||Mean Difference (Final Values)|-6.0|||<|0.001|TWO_SIDED|95.0|-8.4|-3.7|||Mixed Models Analysis|||||-3.7|-8.4|<0.001
72603226|NCT03131687|144735648|OTHER||Mean Difference (Final Values)|-8.8|||<|0.001|TWO_SIDED|95.0|-11.3|-6.4|||Mixed Models Analysis|||||-6.4|-11.3|<0.001
72603227|NCT02651337|144735651|OTHER|It is a one arm clinical study. No comparison between groups was made.|||||||||||||||||The study tested the hypothesis that the Alivio flusher could increase flow in occluded or sluggish flowing catheters. Analysis was made on the basis of the procedural results related to priming the flusher, connecting the flusher to the shunt, flushing the system by dome compression, the ability to refill the dome, and the ability to evacuate the dome.|||
72603228|NCT00869128|144735652|SUPERIORITY_OR_OTHER|||||||0.04|||||||ANOVA|The effect of Circadin was checked by means of 2 x 2 mixed design analysis of variance for repeated measurement.||ANOVA, The effect of Circadin was checked by means of 2 x 2 mixed design analysis of variance for repeated measurement.||||0.04
72603229|NCT02716584|144735667|SUPERIORITY||Effect size|0.41||||0.02|TWO_SIDED||||||ANCOVA|||Data were analyzed using a 2 (groups) x 2 (time: baseline, endpoint) repeated measures ANCOVA with number of exercise sessions attended as a covariate.||||0.02
72603230|NCT02716584|144735668|SUPERIORITY||Effect size|0.35||||0.06|TWO_SIDED||||||ANCOVA|Data were analyzed using a 2 (groups) x 2 (time: baseline, endpoint) repeated measures ANCOVA with number of sessions attended as a covariate.||||||0.06
72603231|NCT02716584|144735669|SUPERIORITY|||||||0.13|||||||ANCOVA|Data were analyzed using a 2 (groups) x 2 (time: baseline, endpoint) repeated measures ANCOVA with number of sessions attended as a covariate.||||||0.13
72603232|NCT02716584|144735670|SUPERIORITY||Effect size|0.19||||0.73|TWO_SIDED|||||The analyses for cohorts 1 and 2 utilized the a priori endpoint assessment conducted 1-2 weeks after completion of training.|ANCOVA|The data were analyzed using a 2 (groups) x 2 (time: baseline, endpoint) repeated measures ANCOVA with number of sessions attended as a covariate.||||||0.73
72603233|NCT02716584|144735670|SUPERIORITY||Effect size|0.73||||0.33|TWO_SIDED|||||For cohort 3, positive affect was measured at baseline and a midpoint assessment.|ANCOVA|The data were analyzed using a 2 (groups) x 2 (time: baseline, midpoint) repeated measures ANCOVA with number of sessions attended as a covariate.||||||.33
72603234|NCT02716584|144735671|SUPERIORITY||Effect size|-0.21||||0.62|TWO_SIDED|||||The analyses for cohorts 1 and 2 utilized the a priori endpoint assessment conducted 1-2 weeks after completion of training.|ANCOVA|The data were analyzed using a 2 (groups) x 2 (time: baseline, endpoint) repeated measures ANCOVA with number of sessions attended as a covariate.||||||0.62
72603235|NCT02716584|144735671|SUPERIORITY||Effect size|0.77||||0.23|TWO_SIDED|||||For cohort 3, positive affect was measured at a baseline and midpoint assessment.|ANCOVA|The data were analyzed using a 2 (groups) x 2 (time: baseline, midpoint) repeated measures ANCOVA with number of sessions attended as a covariate.||||||.23
72603236|NCT02716584|144735672|SUPERIORITY||Effect size|0.02||||0.57|TWO_SIDED||||||ANCOVA|Data were analyzed using a 2 (groups) x 2 (time: baseline, endpoint) repeated measures ANCOVA with number of sessions attended as a covariate.||||||0.57
72603237|NCT02716584|144735673|SUPERIORITY||Effect size|0.35||||0.12|TWO_SIDED||||||ANCOVA|Data were analyzed using a 2 (groups) x 2 (time: baseline, endpoint) repeated measures ANCOVA with number of sessions attended as a covariate.||||||0.12
72603238|NCT02716584|144735674|SUPERIORITY||Effect size|0.72||||0.07|TWO_SIDED||||||ANCOVA|Data were analyzed using a 2 (groups) x 2 (time: baseline, endpoint) repeated measures ANCOVA with number of sessions attended as a covariate.||||||0.07
72603239|NCT02716584|144735675|SUPERIORITY||Effect size|0.0||||0.88|TWO_SIDED||||||ANCOVA|Data were analyzed using a 2 (groups) x 2 (time: baseline, endpoint) repeated measures ANCOVA with number of sessions attended as a covariate.||||||0.88
72603240|NCT02716584|144735676|SUPERIORITY||Effect size|0.05||||0.86|TWO_SIDED||||||ANCOVA|Data were analyzed using a 2 (groups) x 2 (time: baseline, endpoint) repeated measures ANCOVA with number of sessions attended as a covariate.||||||0.86
72603241|NCT03272347|144735708|OTHER|The 95% confidence intervals (CIs) were calculated using stratum-adjusted Mantel-Haenszel method with the difference weighted by the harmonic mean of sample size per arm for each stratum (screening HIV-1 RNA ≤100,000 or \>100,000 copies/mL).|Treatment Difference|2.9|||||TWO_SIDED|95.0|-12.5|18.3|||||Islatravir minus DOR/3TC/TDF|Treatment difference in percent response||18.3|-12.5|
72603242|NCT03272347|144735708|OTHER|The 95% CIs were calculated using stratum-adjusted Mantel-Haenszel method with the difference weighted by the harmonic mean of sample size per arm for each stratum (screening HIV-1 RNA ≤100,000 or \>100,000 copies/mL).|Treatment Difference|9.6|||||TWO_SIDED|95.0|-3.8|23.0|||||Islatravir minus DOR/3TC/TDF|Treatment difference in percent response||23.0|-3.8|
72603243|NCT03272347|144735708|OTHER|The 95% CIs were calculated using stratum-adjusted Mantel-Haenszel method with the difference weighted by the harmonic mean of sample size per arm for each stratum (screening HIV-1 RNA ≤100,000 or \>100,000 copies/mL).|Treatment Difference|0.2|||||TWO_SIDED|95.0|-16.0|16.3|||||Islatravir minus DOR/3TC/TDF|Treatment difference in percent response||16.3|-16.0|
72603244|NCT03272347|144735709|OTHER|The 95% CIs were calculated using stratum-adjusted Mantel-Haenszel method with the difference weighted by the harmonic mean of sample size per arm for each stratum (screening HIV-1 RNA ≤100,000 or \>100,000 copies/mL).|Treatment Difference|6.1|||||TWO_SIDED|95.0|-12.2|24.4|||||Islatravir minus DOR/3TC/TDF|Treatment difference in percent response||24.4|-12.2|
72603245|NCT03272347|144735709|OTHER|The 95% CIs were calculated using stratum-adjusted Mantel-Haenszel method with the difference weighted by the harmonic mean of sample size per arm for each stratum (screening HIV-1 RNA ≤100,000 or \>100,000 copies/mL).|Treatment Difference|6.2|||||TWO_SIDED|95.0|-12.2|24.6|||||Islatravir minus DOR/3TC/TDF|Treatment difference in percent response||24.6|-12.2|
72603246|NCT03272347|144735709|OTHER|The 95% CIs were calculated using stratum-adjusted Mantel-Haenszel method with the difference weighted by the harmonic mean of sample size per arm for each stratum (screening HIV-1 RNA ≤100,000 or \>100,000 copies/mL).|Treatment Difference|-6.1|||||TWO_SIDED|95.0|-27.1|14.8|||||Islatravir minus DOR/3TC/TDF|Treatment difference in percent response||14.8|-27.1|
72603247|NCT03272347|144735710|OTHER|Based on Miettinen \& Nurminen method.|Difference in %|2.6|||||TWO_SIDED|95.0|-15.7|20.5|||||Islatravir minus DOR/3TC/TDF|Difference in % Islatravir vs DOR/3TC/TDF||20.5|-15.7|
72603248|NCT03272347|144735710|OTHER|Based on Miettinen \& Nurminen method.|Difference in %|2.9|||||TWO_SIDED|95.0|-15.0|20.8|||||Islatravir minus DOR/3TC/TDF|Difference in % Islatravir vs DOR/3TC/TDF||20.8|-15.0|
72603249|NCT03272347|144735710|OTHER|Based on Miettinen \& Nurminen method.|Difference in %|-9.7|||||TWO_SIDED|95.0|-29.4|10.1|||||Islatravir minus DOR/3TC/TDF|Difference in % Islatravir vs DOR/3TC/TDF||10.1|-29.4|
72603250|NCT03272347|144735711|OTHER|Based on Miettinen \& Nurminen method|Difference in %|0.2|||||TWO_SIDED|95.0|-13.4|14.5|||||Islatravir minus DOR/3TC/TDF|Difference in % Islatravir vs DOR/3TC/TDF||14.5|-13.4|
72603251|NCT03272347|144735711|OTHER|Based on Miettinen \& Nurminen method|Difference in %|-3.2|||||TWO_SIDED|95.0|-16.4|8.5|||||Islatravir minus DOR/3TC/TDF|Difference in % Islatravir vs DOR/3TC/TDF||8.5|-16.4|
72603252|NCT03272347|144735711|OTHER|Based on Miettinen \& Nurminen method|Difference in %|3.2|||||TWO_SIDED|95.0|-10.8|18.1|||||Islatravir minus DOR/3TC/TDF|Difference in % Islatravir vs DOR/3TC/TDF||18.1|-10.8|
72603253|NCT03272347|144735712|OTHER|The 95% CIs were calculated using stratum-adjusted Mantel-Haenszel method with the difference weighted by the harmonic mean of sample size per arm for each stratum (screening HIV-1 RNA ≤100,000 or \>100,000 copies/mL).|Treatment Difference|-9.7|||||TWO_SIDED|95.0|-26.1|6.6|||||Islatravir minus DOR/3TC/TDF|Treatment difference in percent response||6.6|-26.1|
72603254|NCT03272347|144735712|OTHER|The 95% CIs were calculated using stratum-adjusted Mantel-Haenszel method with the difference weighted by the harmonic mean of sample size per arm for each stratum (screening HIV-1 RNA ≤100,000 or \>100,000 copies/mL).|Treatment Difference|-6.2|||||TWO_SIDED|95.0|-21.5|9.1|||||Islatravir minus DOR/3TC/TDF|Treatment difference in percent response||9.1|-21.5|
72603255|NCT03272347|144735712|OTHER|The 95% CIs were calculated using stratum-adjusted Mantel-Haenszel method with the difference weighted by the harmonic mean of sample size per arm for each stratum (screening HIV-1 RNA ≤100,000 or \>100,000 copies/mL).|Treatment Difference|-7.5|||||TWO_SIDED|95.0|-23.9|8.8|||||Islatravir minus DOR/3TC/TDF|Treatment difference in percent response||8.8|-23.9|
72603256|NCT03272347|144735713|OTHER|The 95% CIs were calculated using stratum-adjusted Mantel-Haenszel method with the difference weighted by the harmonic mean of sample size per arm for each stratum (screening HIV-1 RNA ≤100,000 or \>100,000 copies/mL).|Treatment Difference|2.2|||||TWO_SIDED|95.0|-23.4|27.7|||||Islatravir minus DOR/3TC/TDF|Treatment difference in percent response||27.7|-23.4|
72603257|NCT03272347|144735713|OTHER|The 95% CIs were calculated using stratum-adjusted Mantel-Haenszel method with the difference weighted by the harmonic mean of sample size per arm for each stratum (screening HIV-1 RNA ≤100,000 or \>100,000 copies/mL).|Treatment Difference|-3.7|||||TWO_SIDED|95.0|-29.6|22.1|||||Islatravir minus DOR/3TC/TDF|Treatment difference in percent response||22.1|-29.6|
72603258|NCT03272347|144735713|OTHER|The 95% CIs were calculated using stratum-adjusted Mantel-Haenszel method with the difference weighted by the harmonic mean of sample size per arm for each stratum (screening HIV-1 RNA ≤100,000 or \>100,000 copies/mL).|Treatment Difference|-1.3|||||TWO_SIDED|95.0|-27.7|25.2|||||Islatravir minus DOR/3TC/TDF|Treatment difference in percent response||25.2|-27.7|
72603259|NCT03272347|144735715|OTHER|The 95% CI for mean difference in CD4 change was based on t-distribution.|Treatment Difference|78.4|||||TWO_SIDED|95.0|18.8|138.1|||||Islatravir minus DOR/3TC/TDF|Treatment difference in T-cell count||138.1|18.8|
72603260|NCT03272347|144735715|OTHER|The 95% CI for mean difference in CD4 change was based on t-distribution.|Treatment Difference|50.7|||||TWO_SIDED|95.0|-31.7|133.1|||||Islatravir minus DOR/3TC/TDF|Treatment difference in T-cell count||133.1|-31.7|
72603261|NCT03272347|144735715|OTHER|The 95% CI for mean difference in CD4 change was based on t-distribution.|Treatment Difference|0.8|||||TWO_SIDED|95.0|-63.0|64.7|||||Islatravir minus DOR/3TC/TDF|Treatment difference in T-cell count||64.7|-63.0|
72603262|NCT03272347|144735716|OTHER|The 95% CI for mean difference in CD4 change was based on t-distribution.|Treatment Difference|0.6|||||TWO_SIDED|95.0|-74.1|75.3|||||Islatravir minus DOR/3TC/TDF|Treatment difference in T-cell count||75.3|-74.1|
72603263|NCT03272347|144735716|OTHER|The 95% CI for mean difference in CD4 change was based on t-distribution.|Treatment Difference|1.5|||||TWO_SIDED|95.0|-70.7|73.8|||||Islatravir minus DOR/3TC/TDF|Treatment difference in T-cell count||73.8|-70.7|
72603264|NCT03272347|144735716|OTHER|The 95% CI for mean difference in CD4 change was based on t-distribution.|Treatment Difference|-80.8|||||TWO_SIDED|95.0|-165.6|4.0|||||Islatravir minus DOR/3TC/TDF|Treatment difference in T-cell count||4.0|-165.6|
72603265|NCT03272347|144735717|OTHER|The 95% CI for mean difference in CD4 change was based on t-distribution.|Treatment Difference|-25.5|||||TWO_SIDED|95.0|-134.8|83.8|||||Islatravir minus DOR/3TC/TDF|Treatment difference in T-cell count||83.8|-134.8|
72603266|NCT03272347|144735717|OTHER|The 95% CI for mean difference in CD4 change was based on t-distribution.|Treatment Difference|-107.6|||||TWO_SIDED|95.0|-212.1|-3.1|||||Islatravir minus DOR/3TC/TDF|Treatment difference in T-cell count||-3.1|-212.1|
72603267|NCT03272347|144735717|OTHER|The 95% CI for mean difference in CD4 change was based on t-distribution.|Treatment Difference|-132.4|||||TWO_SIDED|95.0|-242.9|-21.9|||||Islatravir minus DOR/3TC/TDF|Treatment difference in T-cell count||-21.9|-242.9|
72603268|NCT03272347|144735718|OTHER|The 95% CI for mean difference in CD4 change was based on t-distribution.|Treatment Difference|-65.6|||||TWO_SIDED|95.0|-195.3|64.0|||||Islatravir minus DOR/3TC/TDF|Treatment difference in T-cell count||64.0|-195.3|
72603269|NCT03272347|144735718|OTHER|The 95% CI for mean difference in CD4 change was based on t-distribution.|Treatment Difference|-61.0|||||TWO_SIDED|95.0|-188.7|66.8|||||Islatravir minus DOR/3TC/TDF|Treatment difference in T-cell count||66.8|-188.7|
72603270|NCT03272347|144735718|OTHER|The 95% CI for mean difference in CD4 change was based on t-distribution.|Treatment Difference|-107.1|||||TWO_SIDED|95.0|-231.2|16.9|||||Islatravir minus DOR/3TC/TDF|Treatment difference in T-cell count||16.9|-231.2|
72603271|NCT03272347|144735720|OTHER|Based on Miettinen \& Nurminen method.|Difference in %|4.9|||||TWO_SIDED|95.0|-20.3|29.6|||||Islatravir minus DOR/3TC/TDF|Difference in % Islatravir vs DOR/3TC/TDF||29.6|-20.3|
72603272|NCT03272347|144735720|OTHER|Based on Miettinen \& Nurminen method.|Difference in %|9.5|||||TWO_SIDED|95.0|-15.4|33.5|||||Islatravir minus DOR/3TC/TDF|Difference in % Islatravir vs DOR/3TC/TDF||33.5|-15.4|
72603273|NCT03272347|144735720|OTHER|Based on Miettinen \& Nurminen method.|Difference in %|-5.3|||||TWO_SIDED|95.0|-30.6|20.7|||||Islatravir minus DOR/3TC/TDF|Difference in % Islatravir vs DOR/3TC/TDF||20.7|-30.6|
72603274|NCT03272347|144735721|OTHER|Based on Miettinen \& Nurminen method.|Difference in %|-3.6|||||TWO_SIDED|95.0|-17.9|8.5|||||Islatravir minus DOR/3TC/TDF|Difference in % Islatravir vs DOR/3TC/TDF||8.5|-17.9|
72603275|NCT03272347|144735721|OTHER|Based on Miettinen \& Nurminen method.|Difference in %|-3.6|||||TWO_SIDED|95.0|-17.9|8.2|||||Islatravir minus DOR/3TC/TDF|Difference in % Islatravir vs DOR/3TC/TDF||8.2|-17.9|
72603276|NCT03272347|144735721|OTHER|Based on Miettinen \& Nurminen method.|Difference in %|3.8|||||TWO_SIDED|95.0|-11.5|20.6|||||Islatravir minus DOR/3TC/TDF|Difference in % Islatravir vs DOR/3TC/TDF||20.6|-11.5|
72603277|NCT02861664|144735790|OTHER||Least square (LS) mean difference|-0.6|||<|0.0001||95.0|-0.8|-0.4||From ANCOVA model with change from baseline in Schiff Sensitivity Score as response and treatment and baseline Schiff sensitivity score as covariates.|ANCOVA||Difference is first named dentifrice minus second named dentifrice such that a negative difference favours first named dentifrice.|||-0.4|-0.8|<.0001
72603278|NCT02603211|144735821|OTHER||||||||||||||||||"We will obtain 20 tactile image data sets from the breast tumor patients. The tactile images will be converted to size and deformation index. Then these two parameters will be converted to the risk score. This is a small number of patients for statistically significance study. Therefore, we plan to use the Leave-One-Out-Cross-Validation (LOOCV) technique to validate the human test results to determine the performance of the device.~We obtain the Risk Score. Risk Score is a unit less numerical value, which can be used as a scale to classify the tumor as malignant and benign. Based on the calculated size of the tumor and measured deformation index, the breast tumors are classified as benign and malignant using scoring method. The risk score will range from 0 to 5, where 0 represents the benign and 5 represents the malignant tumor.~Comparing the Risk Score and the Pathology reports we obtain sensitivity, specificity and accuracy of the system."|||
72603279|NCT03397121|144735829|SUPERIORITY||Mean Difference (Final Values)|-49.52|||<|0.0001|TWO_SIDED|95.0|-55.04|-43.99||The a priori threshold for statistical significance was \<0.05|ANCOVA||Represents the least squares mean difference from Placebo|||-43.99|-55.04|<.0001
72603280|NCT03397121|144735830|SUPERIORITY||Mean Difference (Final Values)|-44.3|||<|0.0001|TWO_SIDED|95.0|-48.48|-40.12||The a priori threshold for statistical significance was \<0.05|ANCOVA||Represents the least squares mean difference from Placebo|||-40.12|-48.48|<0.0001
72603281|NCT03397121|144735831|SUPERIORITY||Mean Difference (Final Values)|-68.89|||<|0.0001|TWO_SIDED|95.0|-77.11|-60.67||The a priori threshold for statistical significance was \<0.05|ANCOVA||Represents the least squares mean difference from Placebo|||-60.67|-77.11|<0.0001
72603282|NCT03397121|144735832|SUPERIORITY||Mean Difference (Final Values)|-62.74|||<|0.0001|TWO_SIDED|95.0|-69.01|-56.48||The a priori threshold for statistical significance was \<0.05|ANCOVA||Represents the least squares mean difference from Placebo|||-56.48|-69.01|<0.0001
72603283|NCT03397121|144735833|SUPERIORITY||Mean Difference (Final Values)|-78.34|||<|0.0001|TWO_SIDED|95.0|-83.65|-73.04||The a priori threshold for statistical significance was \<0.05|ANCOVA||Represents the least squares mean difference from Placebo|||-73.04|-83.65|<0.0001
72603284|NCT03397121|144735834|SUPERIORITY|LS Mean Difference (95% CI) from Placebo|Mean Difference (Final Values)|-31.77|||<|0.0001|TWO_SIDED|95.0|-35.59|-27.94||The a priori threshold for statistical significance was \<0.05|ANCOVA||Represents the least squares mean difference from Placebo|||-27.94|-35.59|<0.0001
72603285|NCT03397121|144735835|SUPERIORITY||Mean Difference (Final Values)|-36.06|||<|0.0001|TWO_SIDED|95.0|-39.99|-32.14||The a priori threshold for statistical significance was \<0.05|ANCOVA||Represents the least squares mean difference from Placebo|||-32.14|-39.99|<0.0001
72603286|NCT03397121|144735836|SUPERIORITY||Mean Difference (Final Values)|-42.36|||<|0.0001|TWO_SIDED|95.0|-47.32|-37.4||The a priori threshold for statistical significance was \<0.05|ANCOVA||Represents the least squares mean difference from Placebo|||-37.40|-47.32|<0.0001
72603287|NCT04085601|144735839|SUPERIORITY||Difference|0.7311|||<|0.0001|TWO_SIDED|95.0|0.572|0.8902||Cochran-Mantel-Haenszel test is stratified by number of packed red blood cell (PRBC) within 12 months prior to screening (\<4, ≥ 4) reported in electronic data capture (EDC) data.|Cochran-Mantel-Haenszel|||||0.8902|0.572|<0.0001
72603288|NCT04085601|144735840|SUPERIORITY||LS mean difference|-1470.38|||<|0.0001|TWO_SIDED|95.0|-2113.44|-827.32||p-value for Baseline, strata and treatment is from LS mean of proc mixed and proc mianalyze based on parameter estimates.|ANCOVA|||||-827.32|-2113.44|<0.0001
72603289|NCT04085601|144735841|SUPERIORITY||Difference|0.5411|||<|0.0001|TWO_SIDED|95.0|0.339|0.7431||Cochran-Mantel-Haenszel test is stratified by number of PRBC within 12 months prior to screening (\<4, ≥ 4) reported in EDC data.|Cochran-Mantel-Haenszel|||||0.7431|0.339|<0.0001
72603290|NCT04085601|144735842|SUPERIORITY||LS mean difference|-103.82||||0.0002|TWO_SIDED|95.0|-158.9|-48.74||P-value for Baseline, strata and treatment is from LS mean of proc mixed and proc mianalyze based on parameter estimates.|ANCOVA|||||-48.74|-158.9|0.0002
72603291|NCT04085601|144735843|SUPERIORITY||LS mean difference|2.67||||0.0019|TWO_SIDED|95.0|0.99|4.35||P-value for baseline, strata and treatment is from LS mean of proc mixed and proc mianalyze based on parameter estimates.|ANCOVA|||||4.35|0.99|0.0019
72603292|NCT04085601|144735844|SUPERIORITY||Difference|-0.7505|||<|0.0001|TWO_SIDED|95.0|-0.9041|-0.5969||Cochran-Mantel-Haenszel test is stratified by number of PRBC within 12 months prior to screening (\<4, ≥4) reported in EDC data.|Cochran-Mantel-Haenszel|||||-0.5969|-0.9041|<0.0001
72603293|NCT04085601|144735845|SUPERIORITY||Difference|0.7241|||<|0.0001|TWO_SIDED|95.0|0.5583|0.8899||Cochran-Mantel-Haenszel test is stratified by number of PRBC within 12 months prior to screening (\<4, ≥4) reported in EDC data.|Cochran-Mantel-Haenszel|||||0.8899|0.5583|<0.0001
72603294|NCT04085601|144735846|SUPERIORITY||Median Difference (Net)|3.0|||<|0.0001|TWO_SIDED|95.0|2.0|4.0||Wilcoxon rank-sum test p-value for the comparison between treatments is based on median using stratified non-parametric analysis. The 95% confidence interval (CI) is constructed using Hodges-Lehmann Estimation of Location Shift.|Wilcoxon Rank-Sum Test|||||4|2|<0.0001
72603295|NCT04085601|144735847|SUPERIORITY||LS mean difference|4.51||||0.061|TWO_SIDED|95.0|-0.21|9.24||P-value for baseline, strata and treatment is from LS mean of proc mixed and proc mianalyze based on parameter estimates.|ANCOVA|||||9.24|-0.21|0.061
72603296|NCT04085601|144735848|SUPERIORITY||Difference|0.3645||||0.001|TWO_SIDED|95.0|0.1648|0.5642|||Cochran-Mantel-Haenszel|||||0.5642|0.1648|0.001
72603297|NCT04085601|144735849|SUPERIORITY||Difference|0.5592|||<|0.0001|TWO_SIDED|95.0|0.3682|0.7502|||Cochran-Mantel-Haenszel|||||0.7502|0.3682|<0.0001
72603298|NCT04085601|144735850|SUPERIORITY||LS mean difference|21.75||||0.0006|TWO_SIDED|95.0|9.35|34.16||P-value for baseline, strata and treatment is from LS mean of proc mixed and proc mianalyze based on parameter estimates.|ANCOVA|||||34.16|9.35|0.0006
72603299|NCT04085601|144735851|SUPERIORITY||LS mean difference|55.79||||0.005|TWO_SIDED|95.0|16.83|94.74||P-value for baseline, strata and treatment is from LS mean of proc mixed and proc mianalyze based on parameter estimates.|ANCOVA|||||94.74|16.83|0.005
72603300|NCT04085601|144735852|SUPERIORITY||Difference|0.4639||||0.0002|TWO_SIDED|95.0|0.2529|0.675||Cochran-Mantel-Haenszel test is stratified by number of PRBC within 12 months prior to screening (\<4, ≥ 4) reported in EDC data.|Cochran-Mantel-Haenszel|||||0.675|0.2529|0.0002
72603301|NCT04085601|144735853|SUPERIORITY||Stratified Hazard Ratio|0.02|||<|0.0001|TWO_SIDED|95.0|0.004|0.091||Hazard ratio is based on cox proportional hazards model.|Stratified Wilcoxon|||||0.091|0.004|<0.0001
72603302|NCT04085601|144735854|SUPERIORITY||Stratified Hazard Ratio|0.025|||<|0.0001|TWO_SIDED|95.0|0.005|0.121|||Stratified Wilcoxon|||||0.121|0.005|<0.0001
72603303|NCT03492437|144735855|OTHER||Ratio of Geometric Least square Mean|151.38|||||TWO_SIDED|90.0|127.35|179.93||||||||179.93|127.35|
72603304|NCT03492437|144735856|OTHER||Ratio of Geometric Least square Mean|144.7|||||TWO_SIDED|90.0|122.89|170.39||||||||170.39|122.89|
72603305|NCT03492437|144735857|OTHER||Ratio of Geometric Least square Mean|138.45|||||TWO_SIDED|90.0|121.59|157.65||||||||157.65|121.59|
72603306|NCT03492437|144735858|OTHER||Median Difference (Net)|0.5|||||TWO_SIDED|90.0|-0.3|1.0||||||||1.0|-0.3|
72603307|NCT02418234|144735869|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Chi-squared|||||||<0.05
72603308|NCT02418234|144735870|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
72603309|NCT04534517|144735871|SUPERIORITY|The superiority of the Test lens was concluded if the lower credible limit of the mean was above the pre-defined threshold 32 points|Mean Estimate|58.6|STANDARD_DEVIATION|3.26|||TWO_SIDED|95.0|52.3|64.9|||Bayesian multivariate random-effects||Included Hyperope group only|It was calculated that 60 participants would have \> 99% power to for the mean CLUE vision scores for each sphere stratum to be above the hypothesis threshold at the 2-week follow-up. Sample size was determined using one sample means test for equivalence||64.9|52.3|
72603310|NCT04534517|144735871|SUPERIORITY|The superiority of the Test lens was concluded if the lower credible limit of the mean was above the pre-defined threshold 40 points for Myopes|Mean Estimate|63.8|STANDARD_DEVIATION|2.97|||TWO_SIDED|95.0|57.9|69.6|||Bayesian multivariate random-effects||Included myope group only.|It was calculated that 60 participants would have \> 99% power to for the mean CLUE vision scores for each sphere stratum to be above the hypothesis threshold at the 2-week follow-up. Sample size was determined using one sample means test for equivalence||69.6|57.9|
72603311|NCT04534517|144735872|SUPERIORITY|The superiority of the Test lens was concluded if the upper credible limit of the mean was below the pre-defined threshold +0.10 logMAR for Distance|Mean estimate|-0.09|STANDARD_DEVIATION|0.0172|||TWO_SIDED|95.0|-0.125|-0.057|||Bayesian normal random-effects model|Repeated Measures||It was calculated that 60 participants would have \> 99% power to for the mean visual performance at each distance to be below the hypothesis threshold at the 2-week follow-up. Sample size was determined using one sample means test for equivalence||-0.057|-0.125|
72603312|NCT04534517|144735872|SUPERIORITY|The superiority of the Test lens was concluded if the upper credible limit of the mean was below the pre-defined threshold +0.17 logMAR for Intermediate|Mean Estimate|-0.057|STANDARD_DEVIATION|0.0171|||TWO_SIDED|95.0|-0.091|-0.024|||Bayesian normal random-effects model|Repeated Measures||It was calculated that 60 participants would have \> 99% power to for the mean visual performance at each distance to be below the hypothesis threshold at the 2-week follow-up. Sample size was determined using one sample means test for equivalence||-0.024|-0.091|
72603313|NCT04534517|144735872|SUPERIORITY|The superiority of the Test lens was concluded if the upper credible limit of the mean was below the pre-defined threshold +0.17 logMAR for Near|Mean Estimate|0.066|STANDARD_DEVIATION|0.0171|||TWO_SIDED|95.0|0.031|0.098|||Bayesian normal random-effects model|Repeated Measures||It was calculated that 60 participants would have \> 99% power to for the mean visual performance at each distance to be below the hypothesis threshold at the 2-week follow-up. Sample size was determined using one sample means test for equivalence||0.098|0.031|
72603314|NCT04534517|144735873|SUPERIORITY|A superiority margin of 5% was used. Upper limit of 95% credible interval was compared to 5%.|Mean Proportion|0.001|STANDARD_DEVIATION|0.0012|||TWO_SIDED|95.0|0.0|0.004|||Bayesian beta-binomial model|Correlated Binary Data||||0.004|0.000|
72603315|NCT04534517|144735874|SUPERIORITY|A superiority margin of 5% was used. Upper limit of the 95% credible interval was compared to 5%|Mean Proportion|0.005|STANDARD_DEVIATION|0.0048|||TWO_SIDED|95.0|0.0|0.018|||Bayesian beta-binomial model|Correlated Binary Data||||0.018|0.000|
72603316|NCT04534517|144735875|SUPERIORITY|A superiority margin of 90% was used. Lower limit of the 95% credible interval was compared to 90%|Mean Proportion|0.992|STANDARD_DEVIATION|0.0072|||TWO_SIDED|95.0|0.973|0.999|||Bayesian beta-binomial model|Correlated Binary Data||||0.999|0.973|
72603317|NCT00823264|144735879|SUPERIORITY_OR_OTHER|||||||0.049|||||||Wilcoxon (Mann-Whitney)|||||||0.049
72603318|NCT05133323|144735880|SUPERIORITY||Mean Difference (Final Values)|-2.0|STANDARD_ERROR_OF_MEAN|0.89||0.0106|ONE_SIDED|90.0||-0.6|||ANCOVA|||||-0.6||0.0106
72603319|NCT00113295|144735884|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.3|||<|0.05||||||No adjustment for multiple testing|t-test, 2 sided||This analysis applies to the additional reduction from phase 2 randomization to phase 2 endpoint in HAM-A scores.|In phase 2, comprising randomized double-blind quetiapine augmentation, change scores were examined with two-tailed, two-sample t tests, utilizing scores at phase 2 randomization as baseline. All analyses were intention to treat (ITT) with the last visit carried forward (LVCF) for subjects that did not complete the study.||||<0.05
72603320|NCT00572455|144735896|SUPERIORITY_OR_OTHER_LEGACY||Least squares (LS) mean difference|3.02||||0.028|TWO_SIDED|90.0|0.78|5.25|||ANCOVA|||Analysis was based on analysis of covariance (ANCOVA) model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||5.25|0.78|0.028
72603321|NCT00572455|144735896|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|4.73|||<|0.001|TWO_SIDED|90.0|2.5|6.96|||ANCOVA|||Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||6.96|2.50|<0.001
72603322|NCT00572455|144735896|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|6.56|||<|0.001|TWO_SIDED|90.0|4.33|8.79|||ANCOVA|||Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||8.79|4.33|<0.001
72603323|NCT00572455|144735896|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|5.78|||<|0.001|TWO_SIDED|90.0|3.6|7.95|||ANCOVA|||Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||7.95|3.60|<0.001
72603324|NCT00572455|144735896|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|5.06|||<|0.001|TWO_SIDED|90.0|2.74|7.37|||ANCOVA|||Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||7.37|2.74|<0.001
72603325|NCT00572455|144735896|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|6.02|||<|0.001|TWO_SIDED|90.0|3.79|8.25|||ANCOVA|||Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||8.25|3.79|<0.001
72603326|NCT00572455|144735897|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.06||||0.171|TWO_SIDED|90.0|-0.21|2.32|||ANCOVA|||Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||2.32|-0.21|0.171
72603327|NCT00572455|144735897|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.45||||0.553|TWO_SIDED|90.0|-0.8|1.7|||ANCOVA|||Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||1.70|-0.80|0.553
72603328|NCT00572455|144735897|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.45||||0.555|TWO_SIDED|90.0|-0.8|1.7|||ANCOVA|||Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||1.70|-0.80|0.555
72603329|NCT00572455|144735897|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.48||||0.053|TWO_SIDED|90.0|0.22|2.73|||ANCOVA|||Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||2.73|0.22|0.053
72603330|NCT00572455|144735897|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|2.54|||<|0.001|TWO_SIDED|90.0|1.29|3.8|||ANCOVA|||Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||3.80|1.29|<0.001
72603331|NCT00572455|144735897|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.81||||0.018|TWO_SIDED|90.0|0.56|3.07|||ANCOVA|||Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to Latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||3.07|0.56|0.018
72603332|NCT00572455|144735901|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|3.62||||0.011|TWO_SIDED|90.0|1.34|5.9|||ANCOVA|||Change at Day 1 8 AM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||5.90|1.34|0.011
72603333|NCT00572455|144735901|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|4.19||||0.004|TWO_SIDED|90.0|1.91|6.47|||ANCOVA|||Change at Day 1 8 AM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||6.47|1.91|0.004
72603334|NCT00572455|144735901|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|6.47|||<|0.001|TWO_SIDED|90.0|4.19|8.75|||ANCOVA|||Change at Day 1 8 AM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||8.75|4.19|<0.001
72603335|NCT00572455|144735901|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|5.32|||<|0.001|TWO_SIDED|90.0|3.11|7.54|||ANCOVA|||Change at Day 1 8 AM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||7.54|3.11|<0.001
72603336|NCT00572455|144735901|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|6.0|||<|0.001|TWO_SIDED|90.0|3.66|8.33|||ANCOVA|||Change at Day 1 8 AM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||8.33|3.66|<0.001
72603337|NCT00572455|144735901|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|5.8|||<|0.001|TWO_SIDED|90.0|3.52|8.08|||ANCOVA|||Change at Day 1 8 AM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||8.08|3.52|<0.001
72603338|NCT00572455|144735901|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|2.44||||0.12|TWO_SIDED|90.0|-0.14|5.02|||ANCOVA|||Change at Day 7 8 AM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||5.02|-0.14|0.120
72603339|NCT00572455|144735901|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|4.55||||0.005|TWO_SIDED|90.0|1.97|7.14|||ANCOVA|||Change at Day 7 8 AM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||7.14|1.97|0.005
72603340|NCT00572455|144735901|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|6.17|||<|0.001|TWO_SIDED|90.0|3.58|8.75|||ANCOVA|||Change at Day 7 8 AM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||8.75|3.58|<0.001
72603341|NCT00572455|144735901|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|6.03|||<|0.001|TWO_SIDED|90.0|3.52|8.54|||ANCOVA|||Change at Day 7 8 AM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||8.54|3.52|<0.001
72603342|NCT00572455|144735901|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|7.31|||<|0.001|TWO_SIDED|90.0|4.66|9.95|||ANCOVA|||Change at Day 7 8 AM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||9.95|4.66|<0.001
72603343|NCT00572455|144735901|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|5.5|||<|0.001|TWO_SIDED|90.0|2.91|8.08|||ANCOVA|||Change at Day 7 8 AM: Analysis was based on ANCOVA model for effect of taprenepag compared to its Vehicle with treatment and baseline IOP as covariates.||8.08|2.91|<0.001
72603344|NCT00572455|144735901|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|4.04||||0.009|TWO_SIDED|90.0|1.56|6.53|||ANCOVA|||Change at Day 7 10 AM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||6.53|1.56|0.009
72603345|NCT00572455|144735901|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|7.0|||<|0.001|TWO_SIDED|90.0|4.49|9.5|||ANCOVA|||Change at Day 7 10 AM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||9.50|4.49|<0.001
72603346|NCT00572455|144735901|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|7.61|||<|0.001|TWO_SIDED|90.0|5.11|10.11|||ANCOVA|||Change at Day 7 10 AM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||10.11|5.11|<0.001
72603347|NCT00572455|144735901|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|7.08|||<|0.001|TWO_SIDED|90.0|4.64|9.53|||ANCOVA|||Change at Day 7 10 AM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||9.53|4.64|<0.001
72603348|NCT00572455|144735901|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|6.01|||<|0.001|TWO_SIDED|90.0|3.4|8.62|||ANCOVA|||Change at Day 7 10 AM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||8.62|3.40|<0.001
72603349|NCT00572455|144735901|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|8.7|||<|0.001|TWO_SIDED|90.0|6.11|11.3|||ANCOVA|||Change at Day 7 10 AM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||11.30|6.11|<0.001
72603350|NCT00572455|144735901|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|2.66||||0.066|TWO_SIDED|90.0|0.29|5.02|||ANCOVA|||Change at Day 7 1 PM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||5.02|0.29|0.066
72416248|NCT01972841|144343305|SUPERIORITY||Rate ratio|0.65|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|0.53|0.79|||Negative binomial regression|||Rate ratio of number of urgency incontinence episodes during the 7-day diary bet. the given combination group \& the given monotherapy group calculated from a negative binomial regression model incl. treatment group, sex, age group (\<65,≥ 65 years), geographic region and previous OAB medication (yes, no) as factors, baseline log(number of urgency incontinence episodes used divided by number of valid diary days) included as a covariate \& postbaseline number of valid diary days as offset variable.||0.79|0.53|<0.001
72603351|NCT00572455|144735901|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|4.13||||0.006|TWO_SIDED|90.0|1.76|6.5|||ANCOVA|||Change at Day 7 1 PM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||6.50|1.76|0.006
72603352|NCT00572455|144735901|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|6.13|||<|0.001|TWO_SIDED|90.0|3.76|8.49|||ANCOVA|||Change at Day 7 1 PM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||8.49|3.76|<0.001
72603353|NCT00572455|144735901|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|5.81|||<|0.001|TWO_SIDED|90.0|3.51|8.11|||ANCOVA|||Change at Day 7 1 PM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||8.11|3.51|<0.001
72603354|NCT00572455|144735901|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|4.02||||0.01|TWO_SIDED|90.0|1.53|6.5|||ANCOVA|||Change at Day 7 1 PM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||6.50|1.53|0.010
72603355|NCT00572455|144735901|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|5.48|||<|0.001|TWO_SIDED|90.0|3.03|7.93|||ANCOVA|||Change at Day 7 1 PM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||7.93|3.03|<0.001
72603356|NCT00572455|144735901|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|4.55||||0.006|TWO_SIDED|90.0|1.91|7.19|||ANCOVA|||Change at Day 7 4 PM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||7.19|1.91|0.006
72603357|NCT00572455|144735901|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|5.3||||0.002|TWO_SIDED|90.0|2.66|7.94|||ANCOVA|||Change at Day 7 4 PM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||7.94|2.66|0.002
72603358|NCT00572455|144735901|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|7.51|||<|0.001|TWO_SIDED|90.0|4.87|10.16|||ANCOVA|||Change at Day 7 4 PM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||10.16|4.87|<0.001
72603359|NCT00572455|144735901|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|9.14|||<|0.001|TWO_SIDED|90.0|6.57|11.71|||ANCOVA|||Change at Day 7 4 PM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||11.71|6.57|<0.001
72603360|NCT00572455|144735901|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|5.69||||0.002|TWO_SIDED|90.0|2.94|8.44|||ANCOVA|||Change at Day 7 4 PM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||8.44|2.94|0.002
72603361|NCT00572455|144735901|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|6.89|||<|0.001|TWO_SIDED|90.0|4.16|9.62|||ANCOVA|||Change at Day 7 4 PM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||9.62|4.16|<0.001
72603362|NCT00572455|144735901|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.83||||0.269|TWO_SIDED|90.0|-0.91|4.58|||ANCOVA|||Change at Day 14 8 AM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||4.58|-0.91|0.269
72603363|NCT00572455|144735901|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|4.49||||0.009|TWO_SIDED|90.0|1.75|7.24|||ANCOVA|||Change at Day 14 8 AM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||7.24|1.75|0.009
72603364|NCT00572455|144735901|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|6.83|||<|0.001|TWO_SIDED|90.0|4.08|9.57|||ANCOVA|||Change at Day 14 8 AM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||9.57|4.08|<0.001
72603365|NCT00572455|144735901|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|6.18|||<|0.001|TWO_SIDED|90.0|3.52|8.84|||ANCOVA|||Change at Day 14 8 AM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||8.84|3.52|<0.001
72603366|NCT00572455|144735901|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|5.52||||0.002|TWO_SIDED|90.0|2.71|8.33|||ANCOVA|||Change at Day 14 8 AM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||8.33|2.71|0.002
72603367|NCT00572455|144735901|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|6.76|||<|0.001|TWO_SIDED|90.0|4.01|9.5|||ANCOVA|||Change at Day 14 8 AM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||9.50|4.01|<0.001
72603368|NCT00572455|144735901|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|3.36||||0.024|TWO_SIDED|90.0|0.95|5.76|||ANCOVA|||Change at Day 14 10 AM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||5.76|0.95|0.024
72603369|NCT00572455|144735901|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|5.24|||<|0.001|TWO_SIDED|90.0|2.82|7.66|||ANCOVA|||Change at Day 14 10 AM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||7.66|2.82|<0.001
72603370|NCT00572455|144735901|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|6.64|||<|0.001|TWO_SIDED|90.0|4.23|9.06|||ANCOVA|||Change at Day 14 10 AM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||9.06|4.23|<0.001
72603371|NCT00572455|144735901|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|5.22|||<|0.001|TWO_SIDED|90.0|2.87|7.58|||ANCOVA|||Change at Day 14 10 AM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||7.58|2.87|<0.001
72603372|NCT00572455|144735901|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|3.88||||0.012|TWO_SIDED|90.0|1.39|6.37|||ANCOVA|||Change at Day 14 10 AM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||6.37|1.39|0.012
72603373|NCT00572455|144735901|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|6.98|||<|0.001|TWO_SIDED|90.0|4.48|9.48|||ANCOVA|||Change at Day 14 10 AM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||9.48|4.48|<0.001
72603374|NCT00572455|144735901|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|4.41||||0.003|TWO_SIDED|90.0|2.11|6.72|||ANCOVA|||Change at Day 14 1 PM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||6.72|2.11|0.003
72603375|NCT00572455|144735901|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|5.02|||<|0.001|TWO_SIDED|90.0|2.72|7.33|||ANCOVA|||Change at Day 14 1 PM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||7.33|2.72|<0.001
72603376|NCT00572455|144735901|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|6.58|||<|0.001|TWO_SIDED|90.0|4.27|8.88|||ANCOVA|||Change at Day 14 1 PM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||8.88|4.27|<0.001
72603377|NCT00572455|144735901|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|5.54|||<|0.001|TWO_SIDED|90.0|3.31|7.78|||ANCOVA|||Change at Day 14 1 PM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||7.78|3.31|<0.001
72603378|NCT00572455|144735901|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|4.44||||0.003|TWO_SIDED|90.0|2.06|6.82|||ANCOVA|||Change at Day 14 1 PM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||6.82|2.06|0.003
72603379|NCT00572455|144735901|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|7.08|||<|0.001|TWO_SIDED|90.0|4.7|9.47|||ANCOVA|||Change at Day 14 1 PM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||9.47|4.70|<0.001
72603380|NCT00572455|144735901|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|2.41||||0.103|TWO_SIDED|90.0|-0.02|4.84|||ANCOVA|||Change at Day 14 4 PM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||4.84|-0.02|0.103
72603381|NCT00572455|144735901|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|3.75||||0.013|TWO_SIDED|90.0|1.32|6.18|||ANCOVA|||Change at Day 14 4 PM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||6.18|1.32|0.013
72603382|NCT00572455|144735901|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|5.96|||<|0.001|TWO_SIDED|90.0|3.53|8.39|||ANCOVA|||Change at Day 14 4 PM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||8.39|3.53|<0.001
72603383|NCT00572455|144735901|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|5.87|||<|0.001|TWO_SIDED|90.0|3.5|8.23|||ANCOVA|||Change at Day 14 4 PM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||8.23|3.50|<0.001
72603384|NCT00572455|144735901|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|5.65|||<|0.001|TWO_SIDED|90.0|3.18|8.11|||ANCOVA|||Change at Day 14 4 PM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||8.11|3.18|<0.001
72603385|NCT00572455|144735901|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|5.97|||<|0.001|TWO_SIDED|90.0|3.46|8.48|||ANCOVA|||Change at Day 14 4 PM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||8.48|3.46|<0.001
72603386|NCT00572455|144735903|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.72||||0.377|TWO_SIDED|90.0|-0.63|2.08|||ANCOVA|||Change at Day 1 8 AM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||2.08|-0.63|0.377
72603387|NCT00572455|144735903|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.68||||0.039|TWO_SIDED|90.0|-3.01|-0.35|||ANCOVA|||Change at Day 1 8 AM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||-0.35|-3.01|0.039
72603388|NCT00572455|144735903|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.34||||0.668|TWO_SIDED|90.0|-1.67|0.98|||ANCOVA|||Change at Day 1 8 AM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||0.98|-1.67|0.668
72603389|NCT00572455|144735903|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.26||||0.121|TWO_SIDED|90.0|-0.07|2.59|||ANCOVA|||Change at Day 1 8 AM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||2.59|-0.07|0.121
72603390|NCT00572455|144735903|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.67||||0.039|TWO_SIDED|90.0|0.34|2.99|||ANCOVA|||Change at Day 1 8 AM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||2.99|0.34|0.039
72603391|NCT00572455|144735903|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.99||||0.22|TWO_SIDED|90.0|-0.34|2.31|||ANCOVA|||Change at Day 1 8 AM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||2.31|-0.34|0.220
72603392|NCT00572455|144735903|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.3||||0.098|TWO_SIDED|90.0|0.01|2.59|||ANCOVA|||Change at Day 7 8 AM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||2.59|0.01|0.098
72603393|NCT00572455|144735903|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.5||||0.519|TWO_SIDED|90.0|-0.77|1.77|||ANCOVA|||Change at Day 7 8 AM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||1.77|-0.77|0.519
72603394|NCT00572455|144735903|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.27||||0.724|TWO_SIDED|90.0|-1.0|1.55|||ANCOVA|||Change at Day 7 8 AM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||1.55|-1.00|0.724
72603395|NCT00572455|144735903|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.46||||0.059|TWO_SIDED|90.0|0.19|2.74|||ANCOVA|||Change at Day 7 8 AM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||2.74|0.19|0.059
72603396|NCT00572455|144735903|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|2.71|||<|0.001|TWO_SIDED|90.0|1.43|3.98|||ANCOVA|||Change at Day 7 8 AM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||3.98|1.43|<0.001
72603397|NCT00572455|144735903|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|2.09||||0.008|TWO_SIDED|90.0|0.82|3.37|||ANCOVA|||Change at Day 7 8 AM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||3.37|0.82|0.008
72603398|NCT00572455|144735903|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.32||||0.068|TWO_SIDED|90.0|0.13|2.51|||ANCOVA|||Change at Day 7 10 AM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||2.51|0.13|0.068
72603399|NCT00572455|144735903|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.01||||0.994|TWO_SIDED|90.0|-1.16|1.18|||ANCOVA|||Change at Day 7 10 AM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||1.18|-1.16|0.994
72603400|NCT00572455|144735903|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.5||||0.494|TWO_SIDED|90.0|-0.7|1.69|||ANCOVA|||Change at Day 7 10 AM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||1.69|-0.70|0.494
72603401|NCT00572455|144735903|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.39||||0.063|TWO_SIDED|90.0|0.16|2.62|||ANCOVA|||Change at Day 7 10 AM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||2.62|0.16|0.063
72603402|NCT00572455|144735903|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|2.15||||0.004|TWO_SIDED|90.0|0.95|3.34|||ANCOVA|||Change at Day 7 10 AM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||3.34|0.95|0.004
72603403|NCT00572455|144735903|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|2.17||||0.004|TWO_SIDED|90.0|0.97|3.38|||ANCOVA|||Change at Day 7 10 AM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||3.38|0.97|0.004
72603404|NCT00572455|144735903|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.55||||0.038|TWO_SIDED|90.0|0.32|2.77|||ANCOVA|||Change at Day 7 1 PM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||2.77|0.32|0.038
72603405|NCT00572455|144735903|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.48||||0.512|TWO_SIDED|90.0|-0.72|1.68|||ANCOVA|||Change at Day 7 1 PM : Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||1.68|-0.72|0.512
72603406|NCT00572455|144735903|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.66||||0.373|TWO_SIDED|90.0|-0.56|1.89|||ANCOVA|||Change at Day 7 1 PM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||1.89|-0.56|0.373
72603407|NCT00572455|144735903|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.31||||0.088|TWO_SIDED|90.0|0.05|2.56|||ANCOVA|||Change at Day 7 1 PM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||2.56|0.05|0.088
72603408|NCT00572455|144735903|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|2.21||||0.004|TWO_SIDED|90.0|0.98|3.44|||ANCOVA|||Change at Day 7 1 PM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||3.44|0.98|0.004
72603409|NCT00572455|144735903|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|2.33||||0.003|TWO_SIDED|90.0|1.09|3.57|||ANCOVA|||Change at Day 7 1 PM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||3.57|1.09|0.003
72603410|NCT00572455|144735903|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|1.87||||0.01|TWO_SIDED|90.0|0.69|3.04|||ANCOVA|||Change at Day 7 4 PM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||3.04|0.69|0.010
72603411|NCT00572455|144735903|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.89||||0.205|TWO_SIDED|90.0|-0.27|2.05|||ANCOVA|||Change at Day 7 4 PM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||2.05|-0.27|0.205
72603412|NCT00572455|144735903|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.44||||0.045|TWO_SIDED|90.0|0.26|2.63|||ANCOVA|||Change at Day 7 4 PM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||2.63|0.26|0.045
72603413|NCT00572455|144735903|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|2.09||||0.005|TWO_SIDED|90.0|0.88|3.31|||ANCOVA|||Change at Day 7 4 PM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||3.31|0.88|0.005
72603414|NCT00572455|144735903|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|2.51|||<|0.001|TWO_SIDED|90.0|1.33|3.7|||ANCOVA|||Change at Day 7 4 PM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||3.70|1.33|<0.001
72603415|NCT00572455|144735903|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|2.29||||0.002|TWO_SIDED|90.0|1.1|3.48|||ANCOVA|||Change at Day 7 4 PM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||3.48|1.10|0.002
72603416|NCT00572455|144735903|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.27||||0.757|TWO_SIDED|90.0|-1.15|1.69|||ANCOVA|||Change at Day 14 8 AM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||1.69|-1.15|0.757
72603417|NCT00572455|144735903|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.13||||0.878|TWO_SIDED|90.0|-1.54|1.27|||ANCOVA|||Change at Day 14 8 AM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||1.27|-1.54|0.878
72603418|NCT00572455|144735903|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.24||||0.78|TWO_SIDED|90.0|-1.64|1.17|||ANCOVA|||Change at Day 14 8 AM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||1.17|-1.64|0.780
72603419|NCT00572455|144735903|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.36||||0.67|TWO_SIDED|90.0|-1.04|1.77|||ANCOVA|||Change at Day 14 8 AM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||1.77|-1.04|0.670
72603420|NCT00572455|144735903|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.98||||0.021|TWO_SIDED|90.0|0.58|3.38|||ANCOVA|||Change at Day 14 8 AM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||3.38|0.58|0.021
72603421|NCT00572455|144735903|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.31||||0.126|TWO_SIDED|90.0|-0.1|2.71|||ANCOVA|||Change at Day 14 8 AM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||2.71|-0.10|0.126
72603422|NCT00572455|144735903|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.97||||0.215|TWO_SIDED|90.0|-0.32|2.26|||ANCOVA|||Change at Day 14 10 AM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||2.26|-0.32|0.215
72603423|NCT00572455|144735903|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.37||||0.635|TWO_SIDED|90.0|-1.65|0.91|||ANCOVA|||Change at Day 14 10 AM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||0.91|-1.65|0.635
72603424|NCT00572455|144735903|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.06||||0.934|TWO_SIDED|90.0|-1.35|1.22|||ANCOVA|||Change at Day 14 10 AM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||1.22|-1.35|0.934
72603425|NCT00572455|144735903|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.56||||0.478|TWO_SIDED|90.0|-0.74|1.87|||ANCOVA|||Change at Day 14 10 AM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||1.87|-0.74|0.478
72416249|NCT01972841|144343305|SUPERIORITY||Rate ratio|0.84|STANDARD_ERROR_OF_MEAN|0.1||0.084|TWO_SIDED|95.0|0.68|1.02|||Negative binomial regression|||Rate ratio of number of urgency incontinence episodes during the 7-day diary bet. the given combination group \& the given monotherapy group calculated from a negative binomial regression model incl. treatment group, sex, age group (\<65,≥ 65 years), geographic region and previous OAB medication (yes, no) as factors, baseline log(number of urgency incontinence episodes used divided by number of valid diary days) included as a covariate \& postbaseline number of valid diary days as offset variable.||1.02|0.68|0.084
72603426|NCT00572455|144735903|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|2.57||||0.002|TWO_SIDED|90.0|1.26|3.87|||ANCOVA|||Change at Day 14 10 AM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||3.87|1.26|0.002
72603427|NCT00572455|144735903|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.99||||0.013|TWO_SIDED|90.0|0.68|3.3|||ANCOVA|||Change at Day 14 10 AM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||3.30|0.68|0.013
72603428|NCT00572455|144735903|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.27||||0.736|TWO_SIDED|90.0|-1.04|1.57|||ANCOVA|||Change at Day 14 1 PM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||1.57|-1.04|0.736
72603429|NCT00572455|144735903|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.68||||0.386|TWO_SIDED|90.0|-1.96|0.61|||ANCOVA|||Change at Day 14 1 PM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||0.61|-1.96|0.386
72603430|NCT00572455|144735903|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.05||||0.948|TWO_SIDED|90.0|-1.35|1.24|||ANCOVA|||Change at Day 14 1 PM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||1.24|-1.35|0.948
72603431|NCT00572455|144735903|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.09||||0.908|TWO_SIDED|90.0|-1.41|1.22|||ANCOVA|||Change at Day 14 1 PM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||1.22|-1.41|0.908
72603432|NCT00572455|144735903|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.97||||0.015|TWO_SIDED|90.0|0.65|3.28|||ANCOVA|||Change at Day 14 1 PM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||3.28|0.65|0.015
72603433|NCT00572455|144735903|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.6||||0.046|TWO_SIDED|90.0|0.29|2.92|||ANCOVA|||Change at Day 14 1 PM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||2.92|0.29|0.046
72603434|NCT00572455|144735903|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.6||||0.042|TWO_SIDED|90.0|0.31|2.89|||ANCOVA|||Change at Day 14 4 PM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||2.89|0.31|0.042
72603435|NCT00572455|144735903|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.06||||0.94|TWO_SIDED|90.0|-1.22|1.34|||ANCOVA|||Change at Day 14 4 PM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||1.34|-1.22|0.940
72603436|NCT00572455|144735903|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.24||||0.114|TWO_SIDED|90.0|-0.05|2.53|||ANCOVA|||Change at Day 14 4 PM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||2.53|-0.05|0.114
72603437|NCT00572455|144735903|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.97||||0.228|TWO_SIDED|90.0|-0.35|2.28|||ANCOVA|||Change at Day 14 4 PM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||2.28|-0.35|0.228
72603438|NCT00572455|144735903|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|2.29||||0.005|TWO_SIDED|90.0|0.98|3.6|||ANCOVA|||Change at Day 14 4 PM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||3.60|0.98|0.005
72603439|NCT00572455|144735903|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.48||||0.063|TWO_SIDED|90.0|0.17|2.79|||ANCOVA|||Change at Day 14 4 PM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||2.79|0.17|0.063
72603440|NCT00572455|144735903|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.5||||0.562|TWO_SIDED|90.0|-0.92|1.91|||ANCOVA|||Change at Day 28 8 AM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||1.91|-0.92|0.562
72603441|NCT00572455|144735903|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.67||||0.431|TWO_SIDED|90.0|-0.73|2.07|||ANCOVA|||Change at Day 28 8 AM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||2.07|-0.73|0.431
72603442|NCT00572455|144735903|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.22||||0.795|TWO_SIDED|90.0|-1.18|1.62|||ANCOVA|||Change at Day 28 8 AM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||1.62|-1.18|0.795
72603443|NCT00572455|144735903|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.83||||0.032|TWO_SIDED|90.0|0.43|3.23|||ANCOVA|||Change at Day 28 8 AM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||3.23|0.43|0.032
72603444|NCT00572455|144735903|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|2.73||||0.002|TWO_SIDED|90.0|1.34|4.13|||ANCOVA|||Change at Day 28 8 AM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||4.13|1.34|0.002
72603445|NCT00572455|144735903|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|2.04||||0.017|TWO_SIDED|90.0|0.64|3.44|||ANCOVA|||Change at Day 28 8 AM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||3.44|0.64|0.017
72603446|NCT00572455|144735903|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.26||||0.124|TWO_SIDED|90.0|-0.09|2.6|||ANCOVA|||Change at Day 28 10 AM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||2.60|-0.09|0.124
72603447|NCT00572455|144735903|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.08||||0.92|TWO_SIDED|90.0|-1.25|1.41|||ANCOVA|||Change at Day 28 10 AM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||1.41|-1.25|0.920
72603448|NCT00572455|144735903|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.12||||0.887|TWO_SIDED|90.0|-1.46|1.22|||ANCOVA|||Change at Day 28 10 AM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||1.22|-1.46|0.887
72603449|NCT00572455|144735903|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.42||||0.083|TWO_SIDED|90.0|0.08|2.77|||ANCOVA|||Change at Day 28 10 AM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||2.77|0.08|0.083
72603450|NCT00572455|144735903|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|2.65||||0.002|TWO_SIDED|90.0|1.29|4.01|||ANCOVA|||Change at Day 28 10 AM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||4.01|1.29|0.002
72603451|NCT00572455|144735903|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|2.3||||0.006|TWO_SIDED|90.0|0.94|3.66|||ANCOVA|||Change at Day 28 10 AM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||3.66|0.94|0.006
72603452|NCT00572455|144735903|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.49||||0.533|TWO_SIDED|90.0|-0.8|1.78|||ANCOVA|||Change at Day 28 1 PM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||1.78|-0.80|0.533
72603453|NCT00572455|144735903|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.02||||0.985|TWO_SIDED|90.0|-1.29|1.26|||ANCOVA|||Change at Day 28 1 PM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||1.26|-1.29|0.985
72603454|NCT00572455|144735903|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.34||||0.665|TWO_SIDED|90.0|-0.95|1.62|||ANCOVA|||Change at Day 28 1 PM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||1.62|-0.95|0.665
72603455|NCT00572455|144735903|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.86||||0.276|TWO_SIDED|90.0|-0.44|2.15|||ANCOVA|||Change at Day 28 1 PM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||2.15|-0.44|0.276
72603456|NCT00572455|144735903|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|2.34||||0.004|TWO_SIDED|90.0|1.04|3.65|||ANCOVA|||Change at Day 28 1 PM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||3.65|1.04|0.004
72603457|NCT00572455|144735903|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|2.04||||0.011|TWO_SIDED|90.0|0.74|3.35|||ANCOVA|||Change at Day 28 1 PM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||3.35|0.74|0.011
72603458|NCT00572455|144735903|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.78||||0.033|TWO_SIDED|90.0|0.41|3.14|||ANCOVA|||Change at Day 28 4 PM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||3.14|0.41|0.033
72603459|NCT00572455|144735903|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.84||||0.302|TWO_SIDED|90.0|-0.5|2.19|||ANCOVA|||Change at Day 28 4 PM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||2.19|-0.50|0.302
72603460|NCT00572455|144735903|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.94||||0.255|TWO_SIDED|90.0|-0.42|2.3|||ANCOVA|||Change at Day 28 4 PM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||2.30|-0.42|0.255
72603461|NCT00572455|144735903|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.08||||0.198|TWO_SIDED|90.0|-0.3|2.46|||ANCOVA|||Change at Day 28 4 PM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||2.46|-0.30|0.198
72603462|NCT00572455|144735903|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|2.68||||0.002|TWO_SIDED|90.0|1.3|4.06|||ANCOVA|||Change at Day 28 4 PM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||4.06|1.30|0.002
72603463|NCT00572455|144735903|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.68||||0.046|TWO_SIDED|90.0|0.3|3.06|||ANCOVA|||Change at Day 28 4 PM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||3.06|0.30|0.046
72603464|NCT04152083|144735919|OTHER||Hazard Ratio (HR)|1.54||||0.0006|TWO_SIDED|95.0|1.2|1.98||Threshold for significance at 0.05 level.|Likelihood ratio test|||The median estimate for each treatment group, hazard ratio, and its 95% confidence interval (CI) were based on the stratified Cox model with Efron's method of tie handling. The analysis was censored at the time point of first rescue medication. The stratification factors were concomitant migraine preventive treatment use and region.||1.98|1.20|0.0006
72603465|NCT04152083|144735920|OTHER||Hazard Ratio (HR)|1.75|||<|0.0001|TWO_SIDED|95.0|1.41|2.19||Threshold for significance at 0.05 level.|Likelihood ratio test|||The median estimate for each treatment group, hazard ratio, and its 95% CI were based on the stratified Cox model with Efron's method of tie handling. The analysis was censored at the time point of first rescue medication. The stratification factors were concomitant migraine preventive treatment use and region.||2.19|1.41|<0.0001
72603466|NCT04152083|144735921|OTHER||Odds Ratio (OR)|2.27||||0.0009|TWO_SIDED|95.0|1.39|3.72||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||Odds ratio and 95% CI were based on Cochran-Mantel-Haenszel (CMH) test adjusted for the study's stratification factors of concomitant migraine preventive treatment use and region.||3.72|1.39|0.0009
72603467|NCT04152083|144735922|OTHER||Odds Ratio (OR)|2.25|||<|0.0001|TWO_SIDED|95.0|1.55|3.25||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||Odds ratio and 95% CI were based on CMH test adjusted for the study's stratification factors of concomitant migraine preventive treatment use and region.||3.25|1.55|<0.0001
72603468|NCT00856999|144735926|EQUIVALENCE|Non-parametric test equivalent to the dependent t-test|||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<.001
72603469|NCT00856999|144735927|EQUIVALENCE|Non-parametric test equivalent to the dependent t-test|||||<|0.0004|||||||Wilcoxon (Mann-Whitney)|||||||<.0004
72603470|NCT00411450|144735975|SUPERIORITY_OR_OTHER||Difference|6.0|||||TWO_SIDED|95.0|-11.0|21.0|||||Difference = Wild type - Mutant|Difference at Week 17||21|-11|
72603471|NCT00411450|144735975|SUPERIORITY_OR_OTHER||Difference|8.0|||||TWO_SIDED|95.0|-9.0|23.0||||||Difference at Week 25||23|-9|
72603472|NCT00411450|144735977|SUPERIORITY_OR_OTHER||Difference|7.0|||||TWO_SIDED|95.0|-11.0|23.0|||||Difference = Wild type - Mutant|||23|-11|
72603473|NCT00411450|144735978|SUPERIORITY_OR_OTHER||Difference|12.5|||||TWO_SIDED|95.0|-6.3|31.4|||||Difference = Wild type - Mutant|Difference at Week 17||31.4|-6.3|
72603474|NCT00411450|144735978|SUPERIORITY_OR_OTHER||Difference|10.9|||||TWO_SIDED|95.0|-8.4|30.2||||||Difference at Week 25||30.2|-8.4|
72603475|NCT00411450|144735979|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.8|||||TWO_SIDED|95.0|0.5|1.1|||||Hazard ratio estimated from a Cox Proportional Hazards regression model with only KRAS effect (Wild type vs. Mutant).|||1.1|0.5|
72603476|NCT00411450|144735980|SUPERIORITY_OR_OTHER||Difference|6.0|||||TWO_SIDED|95.0|-14.0|25.0|||||Difference = Wild type - Mutant|Difference at Week 17||25|-14|
72603477|NCT00411450|144735980|SUPERIORITY_OR_OTHER||Difference|6.0|||||TWO_SIDED|95.0|-14.0|25.0||||||Difference at Week 25||25|-14|
72603478|NCT00411450|144735981|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.7|||||TWO_SIDED|95.0|0.2|2.0|||||Hazard ratio estimated from a Cox Proportional Hazards regression model with only KRAS effect (Wild type vs. Mutant).|||2.0|0.2|
72603479|NCT00411450|144735982|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.6|||||TWO_SIDED|95.0|0.4|0.9|||||Hazard ratio estimated from a Cox Proportional Hazards regression model with only KRAS effect (Wild type vs. Mutant).|||0.9|0.4|
72603480|NCT00411450|144735983|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.7|||||TWO_SIDED|95.0|0.5|1.1|||||Hazard ratio estimated from a Cox Proportional Hazards regression model with only KRAS effect (Wild type vs. Mutant).|||1.1|0.5|
72603481|NCT00411450|144735984|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.8|||||TWO_SIDED|95.0|0.5|1.2|||||Hazard ratio estimated from a Cox Proportional Hazards regression model with only KRAS effect (Wild type vs. Mutant).|||1.2|0.5|
72603482|NCT00614874|144735993|SUPERIORITY_OR_OTHER|||||||0.048||95.0||||Comparison is between baseline and week 12|ANOVA|||||||0.048
72603483|NCT00614874|144735994|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.0|STANDARD_DEVIATION|35.0||0.183||95.0||||comparison was at baseline and week 12|Friedman|||||||0.183
72603484|NCT00614874|144735995|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.09|STANDARD_DEVIATION|0.95||0.398||95.0||||Comparison was at baseline and week 12|Friedman|||||||0.398
72603485|NCT02028507|144736010|SUPERIORITY||Hazard Ratio (HR)|0.7||||0.003|TWO_SIDED|95.0|0.55|0.89|||Regression, Cox|||This statistical Analysis corresponds to Global health status/quality of life scale||0.89|0.55|0.003
72603486|NCT02028507|144736010|SUPERIORITY||Hazard Ratio (HR)|0.62|||<|0.001|TWO_SIDED|95.0|0.5|0.76|||Regression, Cox|||This statistical Analysis corresponds to Physical functioning scale||0.76|0.50|<0.001
72603487|NCT02028507|144736010|SUPERIORITY||Hazard Ratio (HR)|0.63|||<|0.001|TWO_SIDED|95.0|0.51|0.79|||Regression, Cox|||This statistical Analysis corresponds to Role functioning scale||0.79|0.51|<0.001
72603488|NCT02028507|144736010|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.818|TWO_SIDED|95.0|0.76|1.25|||Regression, Cox|||This statistical Analysis corresponds to Emotional functioning scale||1.25|0.76|0.818
72603489|NCT02028507|144736010|SUPERIORITY||Hazard Ratio (HR)|0.7||||0.004|TWO_SIDED|95.0|0.54|0.89|||Regression, Cox|||This statistical Analysis corresponds to Cognitive functioning scale||0.89|0.54|0.004
72603490|NCT02028507|144736010|SUPERIORITY||Hazard Ratio (HR)|0.62|||<|0.001|TWO_SIDED|95.0|0.49|0.78|||Regression, Cox|||This Statistical Analysis corresponds to Social functioning scale||0.78|0.49|<0.001
72603491|NCT02028507|144736011|SUPERIORITY||Hazard Ratio (HR)|0.7||||0.001|TWO_SIDED|95.0|0.57|0.86|||Regression, Cox|||This Statistical Analysis corresponds to Fatigue scale||0.86|0.57|0.001
72603492|NCT02028507|144736011|SUPERIORITY||Hazard Ratio (HR)|0.58|||<|0.001|TWO_SIDED|95.0|0.45|0.76|||Regression, Cox|||This Statistical Analysis corresponds to Nausea and vomiting scale||0.76|0.45|<0.001
72603493|NCT02028507|144736011|SUPERIORITY||Hazard Ratio (HR)|0.78||||0.042|TWO_SIDED|95.0|0.62|0.99|||Regression, Cox|||This Statistical Analysis corresponds to Pain scale||0.99|0.62|0.042
72603494|NCT02028507|144736011|SUPERIORITY||Hazard Ratio (HR)|1.08||||0.599|TWO_SIDED|95.0|0.81|1.44|||Regression, Cox|||This Statistical Analysis corresponds to Dyspnea scale||1.44|0.81|0.599
72603495|NCT02028507|144736011|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.196|TWO_SIDED|95.0|0.64|1.1|||Regression, Cox|||This Statistical Analysis corresponds to Insomnia scale||1.10|0.64|0.196
72603496|NCT02028507|144736011|SUPERIORITY||Hazard Ratio (HR)|0.71||||0.011|TWO_SIDED|95.0|0.54|0.92|||Regression, Cox|||This Statistical Analysis corresponds to Appetite loss scale||0.92|0.54|0.011
72603497|NCT02028507|144736011|SUPERIORITY||Hazard Ratio (HR)|1.08||||0.564|TWO_SIDED|95.0|0.83|1.41|||Regression, Cox|||This Statistical Analysis corresponds to Constipation scale||1.41|0.83|0.564
72603498|NCT02028507|144736011|SUPERIORITY||Hazard Ratio (HR)|0.42|||<|0.001|TWO_SIDED|95.0|0.32|0.55|||Regression, Cox|||This Statistical Analysis corresponds to Diarrhea scale||0.55|0.32|<0.001
72603499|NCT02028507|144736011|SUPERIORITY||Hazard Ratio (HR)|0.78||||0.118|TWO_SIDED|95.0|0.56|1.07|||Regression, Cox|||This Statistical Analysis corresponds to Financial difficulties scale||1.07|0.56|0.118
72603500|NCT02028507|144736012|SUPERIORITY||Hazard Ratio (HR)|0.95||||0.659|TWO_SIDED|95.0|0.74|1.21|||Regression, Cox|||This Statistical Analysis corresponds to Body image scale||1.21|0.74|0.659
72603501|NCT02028507|144736012|SUPERIORITY||Hazard Ratio (HR)|1.01||||0.928|TWO_SIDED|95.0|0.74|1.39|||Regression, Cox|||This Statistical Analysis corresponds to Future perspective scale||1.39|0.74|0.928
72603502|NCT02028507|144736013|SUPERIORITY||Hazard Ratio (HR)|0.79||||0.029|TWO_SIDED|95.0|0.64|0.98|||Regression, Cox|||This Statistical Analysis corresponds to Systemic side-effects scale||0.98|0.64|0.029
72603503|NCT02028507|144736013|SUPERIORITY||Hazard Ratio (HR)|0.93||||0.571|TWO_SIDED|95.0|0.71|1.21|||Regression, Cox|||This Statistical Analysis corresponds to Breast symptoms scale||1.21|0.71|0.571
72603504|NCT02028507|144736013|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.187|TWO_SIDED|95.0|0.66|1.09|||Regression, Cox|||This Statistical Analysis corresponds to Arm symptoms scale||1.09|0.66|0.187
72603505|NCT01808261|144736020|OTHER||Mean Difference (Net)|0.0443|STANDARD_ERROR_OF_MEAN|0.0809||0.713||95.0|-0.119|0.2||P-value presented is the posterior probability that the treatment difference (GSK249320 15mg/kg - placebo) is greater than 0 m/s at Month 3/Day 90.|Bayesian method|||Credible intervals are displayed as confidence intervals. Posterior means, standard deviations, and credible intervals are provided in the table.||0.2|-0.119|0.713
72603506|NCT01808261|144736021|OTHER||Mean Difference (Net)|0.0794|STANDARD_ERROR_OF_MEAN|0.0857||0.828|TWO_SIDED|95.0|-0.093|0.247||P-value presented is the posterior probability that the treatment difference (GSK249320 15mg/kg - placebo) is greater than 0 m/s at Month 6/Day 180.|Bayesian method|||Credible intervals are displayed as confidence intervals. Posterior means, standard deviations, and credible intervals are provided in the table.||0.247|-0.093|0.828
72603507|NCT01808261|144736023|OTHER||Mean Difference (Net)|2.408|STANDARD_ERROR_OF_MEAN|2.7495|||TWO_SIDED|95.0|-3.067|7.883||||||Statistical data for Day 30. The point estimate and confidence interval are for the adjusted mean difference based on least square estimates.||7.883|-3.067|
72603508|NCT01808261|144736023|OTHER||Mean Difference (Net)|3.015|STANDARD_ERROR_OF_MEAN|2.8732|||TWO_SIDED|95.0|-2.704|8.735||||||Statistical data for Day 60. The point estimate and confidence interval are for the adjusted mean difference based on least square estimates.||8.735|-2.704|
72603509|NCT01808261|144736023|OTHER||Mean Difference (Net)|2.435|STANDARD_ERROR_OF_MEAN|3.5633|||TWO_SIDED|95.0|-4.668|9.538||||||Statistical data for Day 90. The point estimate and confidence interval are for the adjusted mean difference based on least square estimates.||9.538|-4.668|
72603510|NCT01808261|144736023|OTHER||Mean Difference (Net)|3.944|STANDARD_ERROR_OF_MEAN|3.5635|||TWO_SIDED|95.0|-3.15|11.037||||||Statistical data for Day 180. The point estimate and confidence interval are for the adjusted mean difference based on least square estimates.||11.037|-3.15|
72603511|NCT00656175|144736080|SUPERIORITY_OR_OTHER|||||||0.52||95.0|||||Wilcoxon (Mann-Whitney)|||Wilcoxon sign-rank test used for statistical significance.||||0.52
72603512|NCT03365934|144736196|SUPERIORITY|||||||0.071225|||||||t-test, 2 sided|||||||0.071225
72603513|NCT03365934|144736196|SUPERIORITY|||||||0.092027|||||||t-test, 2 sided|||||||0.092027
72603514|NCT03365934|144736196|SUPERIORITY|||||||0.601716|||||||t-test, 2 sided|||||||0.601716
72603515|NCT03365934|144736196|SUPERIORITY|||||||0.639911|||||||t-test, 2 sided|||||||0.639911
72603516|NCT03365934|144736196|SUPERIORITY|||||||0.842476|||||||t-test, 2 sided|||||||0.842476
72603517|NCT03365934|144736196|SUPERIORITY|||||||0.999941|||||||t-test, 2 sided|||||||0.999941
72603518|NCT03365934|144736196|SUPERIORITY|||||||0.883479|||||||t-test, 2 sided|||||||0.883479
72603519|NCT03365934|144736196|SUPERIORITY|||||||0.782208|||||||t-test, 2 sided|||||||0.782208
72603520|NCT03365934|144736196|SUPERIORITY|||||||0.607134|||||||t-test, 2 sided|||||||0.607134
72603521|NCT03365934|144736196|SUPERIORITY|||||||0.939549|||||||t-test, 2 sided|||||||0.939549
72603522|NCT03365934|144736196|SUPERIORITY|||||||0.86475|||||||t-test, 2 sided|||||||0.86475
72603523|NCT03365934|144736196|SUPERIORITY|||||||0.704759|||||||t-test, 2 sided|||||||0.704759
72603524|NCT03365934|144736196|SUPERIORITY|||||||0.999989|||||||t-test, 2 sided|||||||0.999989
72603525|NCT03365934|144736196|SUPERIORITY|||||||0.997568|||||||t-test, 2 sided|||||||0.997568
72603526|NCT03365934|144736196|SUPERIORITY|||||||0.999518|||||||t-test, 2 sided|||||||0.999518
72603527|NCT03365934|144736197|SUPERIORITY|||||||0.985332|||||||t-test, 2 sided|||||||0.985332
72603528|NCT03365934|144736197|SUPERIORITY|||||||1|||||||t-test, 2 sided|||||||1
72603529|NCT03365934|144736197|SUPERIORITY|||||||0.870459|||||||t-test, 2 sided|||||||0.870459
72603530|NCT03365934|144736197|SUPERIORITY|||||||0.004963|||||||t-test, 2 sided|||||||0.004963
72603531|NCT03365934|144736197|SUPERIORITY|||||||0.071935|||||||t-test, 2 sided|||||||0.071935
72603532|NCT03365934|144736197|SUPERIORITY|||||||0.988995|||||||t-test, 2 sided|||||||0.988995
72603533|NCT03365934|144736197|SUPERIORITY|||||||0.545378|||||||t-test, 2 sided|||||||0.545378
72603534|NCT03365934|144736197|SUPERIORITY|||||||0.000649|||||||t-test, 2 sided|||||||0.000649
72603535|NCT03365934|144736197|SUPERIORITY|||||||0.0146|||||||t-test, 2 sided|||||||0.014600
72603536|NCT03365934|144736197|SUPERIORITY|||||||0.854566|||||||t-test, 2 sided|||||||0.854566
72603537|NCT03365934|144736197|SUPERIORITY|||||||0.004322|||||||t-test, 2 sided|||||||0.004322
72603538|NCT03365934|144736197|SUPERIORITY|||||||0.0651|||||||t-test, 2 sided|||||||0.0651
72603539|NCT03365934|144736197|SUPERIORITY|||||||0.300536|||||||t-test, 2 sided|||||||0.300536
72603540|NCT03365934|144736197|SUPERIORITY|||||||0.753883|||||||t-test, 2 sided|||||||0.753883
72603541|NCT03365934|144736197|SUPERIORITY|||||||0.97621|||||||t-test, 2 sided|||||||0.97621
72603542|NCT03365934|144736198|SUPERIORITY|||||||0.027774|||||||t-test, 2 sided|||||||0.027774
72603543|NCT03365934|144736198|SUPERIORITY|||||||0.08431|||||||t-test, 2 sided|||||||0.08431
72603544|NCT03365934|144736198|SUPERIORITY|||||||0.049247|||||||t-test, 2 sided|||||||0.049247
72603545|NCT03365934|144736198|SUPERIORITY|||||||0.000126|||||||t-test, 2 sided|||||||0.000126
72603546|NCT03365934|144736198|SUPERIORITY|||||||0.010829|||||||t-test, 2 sided|||||||0.010829
72603547|NCT03365934|144736198|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
72603548|NCT03365934|144736198|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
72603549|NCT03365934|144736198|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
72603550|NCT03365934|144736198|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
72603551|NCT03365934|144736198|SUPERIORITY|||||||0.999533|||||||t-test, 2 sided|||||||0.999533
72603552|NCT03365934|144736198|SUPERIORITY|||||||0.4205363|||||||t-test, 2 sided|||||||0.4205363
72603553|NCT03365934|144736198|SUPERIORITY|||||||0.9802252|||||||t-test, 2 sided|||||||0.9802252
72603554|NCT03365934|144736198|SUPERIORITY|||||||0.6845362|||||||t-test, 2 sided|||||||0.6845362
72603555|NCT03365934|144736198|SUPERIORITY|||||||0.9992002|||||||t-test, 2 sided|||||||0.9992002
72603556|NCT03365934|144736198|SUPERIORITY|||||||0.8562779|||||||t-test, 2 sided|||||||0.8562779
72603557|NCT03365934|144736199|SUPERIORITY|||||||0.0403539|||||||t-test, 2 sided|||||||0.0403539
72603558|NCT03365934|144736199|SUPERIORITY|||||||0.2953049|||||||t-test, 2 sided|||||||0.2953049
72603559|NCT03365934|144736199|SUPERIORITY|||||||0.290551|||||||t-test, 2 sided|||||||0.290551
72603560|NCT03365934|144736199|SUPERIORITY|||||||2.47e-05|||||||t-test, 2 sided|||||||0.0000247
72603561|NCT03365934|144736199|SUPERIORITY|||||||0.0133001|||||||t-test, 2 sided|||||||0.0133001
72603562|NCT03365934|144736199|SUPERIORITY|||||||1.67e-05|||||||t-test, 2 sided|||||||0.0000167
72603563|NCT03365934|144736199|SUPERIORITY|||||||2.12e-05|||||||t-test, 2 sided|||||||0.0000212
72603564|NCT03365934|144736199|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
72603565|NCT03365934|144736199|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
72603566|NCT03365934|144736199|SUPERIORITY|||||||0.99999995|||||||t-test, 2 sided|||||||0.99999995
72603567|NCT03365934|144736199|SUPERIORITY|||||||0.0792013|||||||t-test, 2 sided|||||||0.0792013
72603568|NCT03365934|144736199|SUPERIORITY|||||||0.870163|||||||t-test, 2 sided|||||||0.870163
72603569|NCT03365934|144736199|SUPERIORITY|||||||0.103828|||||||t-test, 2 sided|||||||0.103828
72603570|NCT03365934|144736199|SUPERIORITY|||||||0.900265|||||||t-test, 2 sided|||||||0.900265
72603571|NCT03365934|144736199|SUPERIORITY|||||||0.570015|||||||t-test, 2 sided|||||||0.570015
72603572|NCT03365934|144736200|SUPERIORITY|||||||0.882449|||||||t-test, 2 sided|||||||0.882449
72603573|NCT03365934|144736200|SUPERIORITY|||||||0.088558|||||||t-test, 2 sided|||||||0.088558
72603574|NCT03365934|144736200|SUPERIORITY|||||||0.081846|||||||t-test, 2 sided|||||||0.081846
72603575|NCT03365934|144736200|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
72603576|NCT03365934|144736200|SUPERIORITY|||||||3.03e-05|||||||t-test, 2 sided|||||||0.0000303
72603577|NCT03365934|144736200|SUPERIORITY|||||||0.001817|||||||t-test, 2 sided|||||||0.001817
72603578|NCT03365934|144736200|SUPERIORITY|||||||0.001825|||||||t-test, 2 sided|||||||0.001825
72603579|NCT03365934|144736200|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
72603580|NCT03365934|144736200|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
72603581|NCT03365934|144736200|SUPERIORITY|||||||0.999999|||||||t-test, 2 sided|||||||0.999999
72603582|NCT03365934|144736200|SUPERIORITY|||||||0.038836|||||||t-test, 2 sided|||||||0.038836
72603583|NCT03365934|144736200|SUPERIORITY|||||||0.184508|||||||t-test, 2 sided|||||||0.184508
72603584|NCT03365934|144736200|SUPERIORITY|||||||0.062829|||||||t-test, 2 sided|||||||0.062829
72603585|NCT03365934|144736200|SUPERIORITY|||||||0.253458|||||||t-test, 2 sided|||||||0.253458
72603586|NCT03365934|144736200|SUPERIORITY|||||||0.987798|||||||t-test, 2 sided|||||||0.987798
72603587|NCT03365934|144736201|SUPERIORITY|||||||0.516068|||||||t-test, 2 sided|||||||0.516068
72603588|NCT03365934|144736201|SUPERIORITY|||||||0.358412|||||||t-test, 2 sided|||||||0.358412
72603589|NCT03365934|144736201|SUPERIORITY|||||||0.834145|||||||t-test, 2 sided|||||||0.834145
72603590|NCT03365934|144736201|SUPERIORITY|||||||3.5e-05|||||||t-test, 2 sided|||||||0.000035
72603591|NCT03365934|144736201|SUPERIORITY|||||||0.000843|||||||t-test, 2 sided|||||||0.000843
72603592|NCT03365934|144736201|SUPERIORITY|||||||0.002997|||||||t-test, 2 sided|||||||0.002997
72603593|NCT03365934|144736201|SUPERIORITY|||||||0.051717|||||||t-test, 2 sided|||||||0.051717
72603594|NCT03365934|144736201|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
72603595|NCT03365934|144736201|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
72603596|NCT03365934|144736201|SUPERIORITY|||||||0.985602|||||||t-test, 2 sided|||||||0.985602
72603597|NCT03365934|144736201|SUPERIORITY|||||||0.046422|||||||t-test, 2 sided|||||||0.046422
72603598|NCT03365934|144736201|SUPERIORITY|||||||0.28061|||||||t-test, 2 sided|||||||0.28061
72603599|NCT03365934|144736201|SUPERIORITY|||||||0.011015|||||||t-test, 2 sided|||||||0.011015
72603600|NCT03365934|144736201|SUPERIORITY|||||||0.089156|||||||t-test, 2 sided|||||||0.089156
72603601|NCT03365934|144736201|SUPERIORITY|||||||0.963882|||||||t-test, 2 sided|||||||0.963882
72603602|NCT03365934|144736202|SUPERIORITY|||||||0.00526|||||||t-test, 2 sided|||||||0.00526
72603603|NCT03365934|144736202|SUPERIORITY|||||||1|||||||t-test, 2 sided|||||||1
72603604|NCT03365934|144736202|SUPERIORITY|||||||0.914409|||||||t-test, 2 sided|||||||0.914409
72603605|NCT03365934|144736202|SUPERIORITY|||||||0.013004|||||||t-test, 2 sided|||||||0.013004
72603606|NCT03365934|144736202|SUPERIORITY|||||||0.028517|||||||t-test, 2 sided|||||||0.028517
72603607|NCT03365934|144736202|SUPERIORITY|||||||0.001356|||||||t-test, 2 sided|||||||0.001356
72603608|NCT03365934|144736202|SUPERIORITY|||||||5.9e-05|||||||t-test, 2 sided|||||||0.000059
72603609|NCT03365934|144736202|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
72603610|NCT03365934|144736202|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
72603611|NCT03365934|144736202|SUPERIORITY|||||||0.859272|||||||t-test, 2 sided|||||||0.859272
72603612|NCT03365934|144736202|SUPERIORITY|||||||0.002821|||||||t-test, 2 sided|||||||0.002821
72603613|NCT03365934|144736202|SUPERIORITY|||||||0.007492|||||||t-test, 2 sided|||||||0.007492
72603614|NCT03365934|144736202|SUPERIORITY|||||||0.208803|||||||t-test, 2 sided|||||||0.208803
72603615|NCT03365934|144736202|SUPERIORITY|||||||0.341884|||||||t-test, 2 sided|||||||0.341884
72603616|NCT03365934|144736202|SUPERIORITY|||||||0.999531|||||||t-test, 2 sided|||||||0.999531
72603617|NCT03365934|144736203|SUPERIORITY|||||||0.066788|||||||t-test, 2 sided|||||||0.066788
72603618|NCT03365934|144736203|SUPERIORITY|||||||0.942653|||||||t-test, 2 sided|||||||0.942653
72603619|NCT03365934|144736203|SUPERIORITY|||||||0.893545|||||||t-test, 2 sided|||||||0.893545
72603620|NCT03365934|144736203|SUPERIORITY|||||||0.165225|||||||t-test, 2 sided|||||||0.165225
72603621|NCT03365934|144736203|SUPERIORITY|||||||0.140475|||||||t-test, 2 sided|||||||0.140475
72603622|NCT03365934|144736203|SUPERIORITY|||||||0.002026|||||||t-test, 2 sided|||||||0.002026
72603623|NCT03365934|144736203|SUPERIORITY|||||||0.001916|||||||t-test, 2 sided|||||||0.001916
72603624|NCT03365934|144736203|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
72603625|NCT03365934|144736203|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
72603626|NCT03365934|144736203|SUPERIORITY|||||||0.999957|||||||t-test, 2 sided|||||||0.999957
72603627|NCT03365934|144736203|SUPERIORITY|||||||0.672573|||||||t-test, 2 sided|||||||0.672573
72603628|NCT03365934|144736203|SUPERIORITY|||||||0.630145|||||||t-test, 2 sided|||||||0.630145
72603629|NCT03365934|144736203|SUPERIORITY|||||||0.832757|||||||t-test, 2 sided|||||||0.832757
72603630|NCT03365934|144736203|SUPERIORITY|||||||0.803277|||||||t-test, 1 sided|||||||0.803277
72603631|NCT03365934|144736203|SUPERIORITY|||||||1|||||||t-test, 2 sided|||||||1
72603632|NCT03365934|144736204|SUPERIORITY|||||||0.943522|||||||t-test, 2 sided|||||||0.943522
72603633|NCT03365934|144736204|SUPERIORITY|||||||0.002376|||||||t-test, 2 sided|||||||0.002376
72603634|NCT03365934|144736204|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
72603635|NCT03365934|144736204|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
72603636|NCT03365934|144736204|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
72603637|NCT03365934|144736204|SUPERIORITY|||||||0.061015|||||||t-test, 2 sided|||||||0.061015
72603638|NCT03365934|144736204|SUPERIORITY|||||||0.000211|||||||t-test, 2 sided|||||||0.000211
72603639|NCT03365934|144736204|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
72603640|NCT03365934|144736204|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
72603641|NCT03365934|144736204|SUPERIORITY|||||||0.412626|||||||t-test, 2 sided|||||||0.412626
72603642|NCT03365934|144736204|SUPERIORITY|||||||0.104388|||||||t-test, 2 sided|||||||0.104388
72603643|NCT03365934|144736204|SUPERIORITY|||||||0.197791|||||||t-test, 2 sided|||||||0.197791
72603644|NCT03365934|144736204|SUPERIORITY|||||||0.994413|||||||t-test, 2 sided|||||||0.994413
72603645|NCT03365934|144736204|SUPERIORITY|||||||0.999851|||||||t-test, 2 sided|||||||0.999851
72603646|NCT03365934|144736204|SUPERIORITY|||||||0.999621|||||||t-test, 2 sided|||||||0.999621
72603647|NCT03365934|144736205|SUPERIORITY|||||||0.193667|||||||t-test, 2 sided|||||||0.193667
72603648|NCT03365934|144736205|SUPERIORITY|||||||0.526573|||||||t-test, 2 sided|||||||0.526573
72603649|NCT03365934|144736205|SUPERIORITY|||||||0.898749|||||||t-test, 2 sided|||||||0.898749
72603650|NCT03365934|144736205|SUPERIORITY|||||||0.975044|||||||t-test, 2 sided|||||||0.975044
72603651|NCT03365934|144736205|SUPERIORITY|||||||0.760706|||||||t-test, 2 sided|||||||0.760706
72603652|NCT03365934|144736205|SUPERIORITY|||||||0.985237|||||||t-test, 2 sided|||||||0.985237
72603653|NCT03365934|144736205|SUPERIORITY|||||||0.837995|||||||t-test, 2 sided|||||||0.837995
72603654|NCT03365934|144736205|SUPERIORITY|||||||0.592697|||||||t-test, 2 sided|||||||0.592697
72603655|NCT03365934|144736205|SUPERIORITY|||||||0.912495|||||||t-test, 2 sided|||||||0.912495
72603656|NCT03365934|144736205|SUPERIORITY|||||||0.99245|||||||t-test, 2 sided|||||||0.99245
72603657|NCT03365934|144736205|SUPERIORITY|||||||0.925553|||||||t-test, 2 sided|||||||0.925553
72603658|NCT03365934|144736205|SUPERIORITY|||||||0.999171|||||||t-test, 2 sided|||||||0.999171
72603659|NCT03365934|144736205|SUPERIORITY|||||||0.999324|||||||t-test, 2 sided|||||||0.999324
72603660|NCT03365934|144736205|SUPERIORITY|||||||0.999913|||||||t-test, 2 sided|||||||0.999913
72603661|NCT03365934|144736205|SUPERIORITY|||||||0.990516|||||||t-test, 2 sided|||||||0.990516
72603662|NCT03365934|144736206|SUPERIORITY|||||||0.92106|||||||t-test, 2 sided|||||||0.92106
72603663|NCT03365934|144736206|SUPERIORITY|||||||0.976812|||||||t-test, 2 sided|||||||0.976812
72603664|NCT03365934|144736206|SUPERIORITY|||||||0.233992|||||||t-test, 2 sided|||||||0.233992
72603665|NCT03365934|144736206|SUPERIORITY|||||||0.007591|||||||t-test, 2 sided|||||||0.007591
72603666|NCT03365934|144736206|SUPERIORITY|||||||0.038958|||||||t-test, 2 sided|||||||0.038958
72603667|NCT03365934|144736206|SUPERIORITY|||||||0.99809|||||||t-test, 2 sided|||||||0.99809
72603668|NCT03365934|144736206|SUPERIORITY|||||||0.773028|||||||t-test, 2 sided|||||||0.773028
72603669|NCT03365934|144736206|SUPERIORITY|||||||0.135805|||||||t-test, 2 sided|||||||0.135805
72603670|NCT03365934|144736206|SUPERIORITY|||||||0.350556|||||||t-test, 2 sided|||||||0.350556
72603671|NCT03365934|144736206|SUPERIORITY|||||||0.61046|||||||t-test, 2 sided|||||||0.61046
72603672|NCT03365934|144736206|SUPERIORITY|||||||0.062163|||||||t-test, 2 sided|||||||0.062163
72603673|NCT03365934|144736206|SUPERIORITY|||||||0.203418|||||||t-test, 2 sided|||||||0.203418
72603674|NCT03365934|144736206|SUPERIORITY|||||||0.942304|||||||t-test, 2 sided|||||||0.942304
72603675|NCT03365934|144736206|SUPERIORITY|||||||0.995238|||||||t-test, 2 sided|||||||0.995238
72603676|NCT03365934|144736206|SUPERIORITY|||||||0.99858|||||||t-test, 2 sided|||||||0.99858
72603677|NCT03365934|144736207|SUPERIORITY|||||||0.998949|||||||t-test, 2 sided|||||||0.998949
72603678|NCT03365934|144736207|SUPERIORITY|||||||0.111084|||||||t-test, 2 sided|||||||0.111084
72603679|NCT03365934|144736207|SUPERIORITY|||||||0.456846|||||||t-test, 2 sided|||||||0.456846
72603680|NCT03365934|144736207|SUPERIORITY|||||||0.00062|||||||t-test, 2 sided|||||||0.00062
72603681|NCT03365934|144736207|SUPERIORITY|||||||0.006871|||||||t-test, 2 sided|||||||0.006871
72603682|NCT03365934|144736207|SUPERIORITY|||||||0.039407|||||||t-test, 2 sided|||||||0.039407
72603683|NCT03365934|144736207|SUPERIORITY|||||||0.245375|||||||t-test, 2 sided|||||||0.245375
72603684|NCT03365934|144736207|SUPERIORITY|||||||0.000113|||||||t-test, 2 sided|||||||0.000113
72603685|NCT03365934|144736207|SUPERIORITY|||||||0.001612|||||||t-test, 2 sided|||||||0.001612
72603686|NCT03365934|144736207|SUPERIORITY|||||||0.988067|||||||t-test, 2 sided|||||||0.988067
72603687|NCT03365934|144736207|SUPERIORITY|||||||0.599171|||||||t-test, 2 sided|||||||0.599171
72603688|NCT03365934|144736207|SUPERIORITY|||||||0.928722|||||||t-test, 2 sided|||||||0.928722
72603689|NCT03365934|144736207|SUPERIORITY|||||||0.256079|||||||t-test, 2 sided|||||||0.256079
72603690|NCT03365934|144736207|SUPERIORITY|||||||0.626498|||||||t-test, 2 sided|||||||0.626498
72603691|NCT03365934|144736207|SUPERIORITY|||||||0.988693|||||||t-test, 2 sided|||||||0.988693
72603692|NCT03365934|144736208|SUPERIORITY|||||||0.99916|||||||t-test, 2 sided|||||||0.99916
72603693|NCT03365934|144736208|SUPERIORITY|||||||0.016246|||||||t-test, 2 sided|||||||0.016246
72603694|NCT03365934|144736208|SUPERIORITY|||||||0.289112|||||||t-test, 2 sided|||||||0.289112
72603695|NCT03365934|144736208|SUPERIORITY|||||||3.8e-05|||||||t-test, 2 sided|||||||0.000038
72603696|NCT03365934|144736208|SUPERIORITY|||||||0.014558|||||||t-test, 2 sided|||||||0.014558
72603697|NCT03365934|144736208|SUPERIORITY|||||||0.03731|||||||t-test, 2 sided|||||||0.03731
72603698|NCT03365934|144736208|SUPERIORITY|||||||0.465745|||||||t-test, 2 sided|||||||0.465745
72603699|NCT03365934|144736208|SUPERIORITY|||||||0.000112|||||||t-test, 2 sided|||||||0.000112
72603700|NCT03365934|144736208|SUPERIORITY|||||||0.034575|||||||t-test, 2 sided|||||||0.034575
72603701|NCT03365934|144736208|SUPERIORITY|||||||0.889597|||||||t-test, 2 sided|||||||0.889597
72603702|NCT03365934|144736208|SUPERIORITY|||||||0.726932|||||||t-test, 2 sided|||||||0.726932
72603703|NCT03365934|144736208|SUPERIORITY|||||||0.999998|||||||t-test, 2 sided|||||||0.999998
72603704|NCT03365934|144736208|SUPERIORITY|||||||0.130235|||||||t-test, 2 sided|||||||0.130235
72603705|NCT03365934|144736208|SUPERIORITY|||||||0.910989|||||||t-test, 2 sided|||||||0.910989
72603706|NCT03365934|144736208|SUPERIORITY|||||||0.616933|||||||t-test, 2 sided|||||||0.616933
72603707|NCT03365934|144736209|SUPERIORITY|||||||0.999952|||||||t-test, 2 sided|||||||0.999952
72603708|NCT03365934|144736209|SUPERIORITY|||||||0.421347|||||||t-test, 2 sided|||||||0.421347
72603709|NCT03365934|144736209|SUPERIORITY|||||||0.598141|||||||t-test, 2 sided|||||||0.598141
72603710|NCT03365934|144736209|SUPERIORITY|||||||0.000197|||||||t-test, 2 sided|||||||0.000197
72603711|NCT03365934|144736209|SUPERIORITY|||||||0.000115|||||||t-test, 2 sided|||||||0.000115
72603712|NCT03365934|144736209|SUPERIORITY|||||||0.511155|||||||t-test, 2 sided|||||||0.511155
72603713|NCT03365934|144736209|SUPERIORITY|||||||0.693868|||||||t-test, 2 sided|||||||0.693868
72603714|NCT03365934|144736209|SUPERIORITY|||||||0.000232|||||||t-test, 2 sided|||||||0.000232
72603715|NCT03365934|144736209|SUPERIORITY|||||||0.000133|||||||t-test, 2 sided|||||||0.000133
72603716|NCT03365934|144736209|SUPERIORITY|||||||0.999894|||||||t-test, 2 sided|||||||0.999894
72603717|NCT03365934|144736209|SUPERIORITY|||||||0.078046|||||||t-test, 2 sided|||||||0.078046
72603718|NCT03365934|144736209|SUPERIORITY|||||||0.054975|||||||t-test, 2 sided|||||||0.054975
72603719|NCT03365934|144736209|SUPERIORITY|||||||0.050132|||||||t-test, 2 sided|||||||0.050132
72603720|NCT03365934|144736209|SUPERIORITY|||||||0.034793|||||||t-test, 2 sided|||||||0.034793
72603721|NCT03365934|144736209|SUPERIORITY|||||||0.999993|||||||t-test, 2 sided|||||||0.999993
72603722|NCT03365934|144736210|SUPERIORITY|||||||0.997406|||||||t-test, 2 sided|||||||0.997406
72603723|NCT03365934|144736210|SUPERIORITY|||||||0.354187|||||||t-test, 2 sided|||||||0.354187
72603724|NCT03365934|144736210|SUPERIORITY|||||||0.883222|||||||t-test, 2 sided|||||||0.883222
72603725|NCT03365934|144736210|SUPERIORITY|||||||0.000412|||||||t-test, 2 sided|||||||0.000412
72603726|NCT03365934|144736210|SUPERIORITY|||||||0.000332|||||||t-test, 2 sided|||||||0.000332
72603727|NCT03365934|144736210|SUPERIORITY|||||||0.626878|||||||t-test, 2 sided|||||||0.626878
72603728|NCT03365934|144736210|SUPERIORITY|||||||0.984465|||||||t-test, 2 sided|||||||0.984465
72603729|NCT03365934|144736210|SUPERIORITY|||||||0.001845|||||||t-test, 2 sided|||||||0.001845
72603730|NCT03365934|144736210|SUPERIORITY|||||||0.001507|||||||t-test, 2 sided|||||||0.001507
72603731|NCT03365934|144736210|SUPERIORITY|||||||0.970029|||||||t-test, 2 sided|||||||0.970029
72603732|NCT03365934|144736210|SUPERIORITY|||||||0.19886|||||||t-test, 2 sided|||||||0.19886
72603733|NCT03365934|144736210|SUPERIORITY|||||||0.177549|||||||t-test, 2 sided|||||||0.177549
72603734|NCT03365934|144736210|SUPERIORITY|||||||0.041698|||||||t-test, 2 sided|||||||0.041698
72603735|NCT03365934|144736210|SUPERIORITY|||||||0.036131|||||||t-test, 2 sided|||||||0.036131
72603736|NCT03365934|144736210|SUPERIORITY|||||||1|||||||t-test, 2 sided|||||||1
72416250|NCT01972841|144343306|SUPERIORITY||Least squares mean difference|-1.61|STANDARD_ERROR_OF_MEAN|0.76||0.114|TWO_SIDED|95.0|-3.09|-0.13|||Stratified rank ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (solifenacin 5 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||-0.13|-3.09|0.114
72603737|NCT03365934|144736211|SUPERIORITY|||||||1|||||||t-test, 2 sided|||||||1
72603738|NCT03365934|144736211|SUPERIORITY|||||||0.317315|||||||t-test, 2 sided|||||||0.317315
72603739|NCT03365934|144736211|SUPERIORITY|||||||0.829352|||||||t-test, 2 sided|||||||0.829352
72603740|NCT03365934|144736211|SUPERIORITY|||||||0.010561|||||||t-test, 2 sided|||||||0.010561
72603741|NCT03365934|144736211|SUPERIORITY|||||||0.001099|||||||t-test, 2 sided|||||||0.001099
72603742|NCT03365934|144736211|SUPERIORITY|||||||0.175148|||||||t-test, 2 sided|||||||0.175148
72603743|NCT03365934|144736211|SUPERIORITY|||||||0.728796|||||||t-test, 2 sided|||||||0.728796
72603744|NCT03365934|144736211|SUPERIORITY|||||||0.001992|||||||t-test, 2 sided|||||||0.001992
72603745|NCT03365934|144736211|SUPERIORITY|||||||0.000113|||||||t-test, 2 sided|||||||0.000113
72603746|NCT03365934|144736211|SUPERIORITY|||||||0.974567|||||||t-test, 2 sided|||||||0.974567
72603747|NCT03365934|144736211|SUPERIORITY|||||||0.668933|||||||t-test, 2 sided|||||||0.668933
72603748|NCT03365934|144736211|SUPERIORITY|||||||0.239446|||||||t-test, 2 sided|||||||0.239446
72603749|NCT03365934|144736211|SUPERIORITY|||||||0.283848|||||||t-test, 2 sided|||||||0.283848
72603750|NCT03365934|144736211|SUPERIORITY|||||||0.06829|||||||t-test, 2 sided|||||||0.06829
72603751|NCT03365934|144736211|SUPERIORITY|||||||0.979516|||||||t-test, 2 sided|||||||0.979516
72603752|NCT03365934|144736212|SUPERIORITY|||||||0.996522|||||||t-test, 2 sided|||||||0.996522
72603753|NCT03365934|144736212|SUPERIORITY|||||||0.875832|||||||t-test, 2 sided|||||||0.875832
72603754|NCT03365934|144736212|SUPERIORITY|||||||0.938|||||||t-test, 2 sided|||||||0.938
72603755|NCT03365934|144736212|SUPERIORITY|||||||0.038527|||||||t-test, 2 sided|||||||0.038527
72603756|NCT03365934|144736212|SUPERIORITY|||||||0.018334|||||||t-test, 2 sided|||||||0.018334
72603757|NCT03365934|144736212|SUPERIORITY|||||||0.512209|||||||t-test, 2 sided|||||||0.512209
72603758|NCT03365934|144736212|SUPERIORITY|||||||0.665529|||||||t-test, 2 sided|||||||0.665529
72603759|NCT03365934|144736212|SUPERIORITY|||||||0.002257|||||||t-test, 2 sided|||||||0.002257
72603760|NCT03365934|144736212|SUPERIORITY|||||||0.000728|||||||t-test, 2 sided|||||||0.000728
72603761|NCT03365934|144736212|SUPERIORITY|||||||0.999993|||||||t-test, 2 sided|||||||0.999993
72603762|NCT03365934|144736212|SUPERIORITY|||||||0.417914|||||||t-test, 2 sided|||||||0.417914
72603763|NCT03365934|144736212|SUPERIORITY|||||||0.277469|||||||t-test, 2 sided|||||||0.277469
72603764|NCT03365934|144736212|SUPERIORITY|||||||0.385419|||||||t-test, 2 sided|||||||0.385419
72603765|NCT03365934|144736212|SUPERIORITY|||||||0.257647|||||||t-test, 2 sided|||||||0.257647
72603766|NCT03365934|144736212|SUPERIORITY|||||||0.999897|||||||t-test, 2 sided|||||||0.999897
72603767|NCT03365934|144736213|SUPERIORITY|||||||0.862516|||||||t-test, 2 sided|||||||0.862516
72603768|NCT03365934|144736213|SUPERIORITY|||||||0.00473|||||||t-test, 2 sided|||||||0.00473
72603769|NCT03365934|144736213|SUPERIORITY|||||||0.085238|||||||t-test, 2 sided|||||||0.085238
72603770|NCT03365934|144736213|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
72603771|NCT03365934|144736213|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
72603772|NCT03365934|144736213|SUPERIORITY|||||||0.168409|||||||t-test, 2 sided|||||||0.168409
72603773|NCT03365934|144736213|SUPERIORITY|||||||0.652654|||||||t-test, 2 sided|||||||0.652654
72603774|NCT03365934|144736213|SUPERIORITY|||||||0.001436|||||||t-test, 2 sided|||||||0.001436
72603775|NCT03365934|144736213|SUPERIORITY|||||||0.000235|||||||t-test, 2 sided|||||||0.000235
72603776|NCT03365934|144736213|SUPERIORITY|||||||0.974842|||||||t-test, 2 sided|||||||0.974842
72603777|NCT03365934|144736213|SUPERIORITY|||||||0.557877|||||||t-test, 2 sided|||||||0.557877
72603778|NCT03365934|144736213|SUPERIORITY|||||||0.277244|||||||t-test, 2 sided|||||||0.277244
72603779|NCT03365934|144736213|SUPERIORITY|||||||0.195527|||||||t-test, 2 sided|||||||0.195527
72603780|NCT03365934|144736213|SUPERIORITY|||||||0.070843|||||||t-test, 2 sided|||||||0.070843
72603781|NCT03365934|144736213|SUPERIORITY|||||||0.997565|||||||t-test, 2 sided|||||||0.997565
72603782|NCT03365934|144736214|SUPERIORITY|||||||0.016628|||||||t-test, 2 sided|||||||0.016628
72603783|NCT03365934|144736214|SUPERIORITY|||||||0.217862|||||||t-test, 2 sided|||||||0.217862
72603784|NCT03365934|144736214|SUPERIORITY|||||||0.812915|||||||t-test, 2 sided|||||||0.812915
72603785|NCT03365934|144736214|SUPERIORITY|||||||0.999971|||||||t-test, 2 sided|||||||0.999971
72603786|NCT03365934|144736214|SUPERIORITY|||||||0.275557|||||||t-test, 2 sided|||||||0.275557
72603787|NCT03365934|144736214|SUPERIORITY|||||||0.870124|||||||t-test, 2 sided|||||||0.870124
72603788|NCT03365934|144736214|SUPERIORITY|||||||0.380144|||||||t-test, 2 sided|||||||0.380144
72603789|NCT03365934|144736214|SUPERIORITY|||||||0.029518|||||||t-test, 2 sided|||||||0.029518
72603790|NCT03365934|144736214|SUPERIORITY|||||||0.815476|||||||t-test, 2 sided|||||||0.815476
72603791|NCT03365934|144736214|SUPERIORITY|||||||0.944307|||||||t-test, 2 sided|||||||0.944307
72603792|NCT03365934|144736214|SUPERIORITY|||||||0.313389|||||||t-test, 2 sided|||||||0.313389
72603793|NCT03365934|144736214|SUPERIORITY|||||||0.999996|||||||t-test, 2 sided|||||||0.999996
72603794|NCT03365934|144736214|SUPERIORITY|||||||0.894272|||||||t-test, 2 sided|||||||0.894272
72603795|NCT03365934|144736214|SUPERIORITY|||||||0.969093|||||||t-test, 2 sided|||||||0.969093
72603796|NCT03365934|144736214|SUPERIORITY|||||||0.383434|||||||t-test, 2 sided|||||||0.383434
72603797|NCT03365934|144736215|SUPERIORITY|||||||0.393119|||||||t-test, 2 sided|||||||0.393119
72603798|NCT03365934|144736215|SUPERIORITY|||||||0.890335|||||||t-test, 2 sided|||||||0.890335
72603799|NCT03365934|144736215|SUPERIORITY|||||||0.021978|||||||t-test, 2 sided|||||||0.021978
72603800|NCT03365934|144736215|SUPERIORITY|||||||0.000983|||||||t-test, 2 sided|||||||0.000983
72603801|NCT03365934|144736215|SUPERIORITY|||||||0.006615|||||||t-test, 2 sided|||||||0.006615
72603802|NCT03365934|144736215|SUPERIORITY|||||||0.951883|||||||t-test, 2 sided|||||||0.951883
72603803|NCT03365934|144736215|SUPERIORITY|||||||0.692455|||||||t-test, 2 sided|||||||0.692455
72603804|NCT03365934|144736215|SUPERIORITY|||||||0.257254|||||||t-test, 2 sided|||||||0.257254
72603805|NCT03365934|144736215|SUPERIORITY|||||||0.530181|||||||t-test, 2 sided|||||||0.530181
72603806|NCT03365934|144736215|SUPERIORITY|||||||0.219274|||||||t-test, 2 sided|||||||0.219274
72603807|NCT03365934|144736215|SUPERIORITY|||||||0.029675|||||||t-test, 2 sided|||||||0.029675
72603808|NCT03365934|144736215|SUPERIORITY|||||||0.111454|||||||t-test, 2 sided|||||||0.111454
72603809|NCT03365934|144736215|SUPERIORITY|||||||0.995849|||||||t-test, 2 sided|||||||0.995849
72603810|NCT03365934|144736215|SUPERIORITY|||||||0.999994|||||||t-test, 2 sided|||||||0.999994
72603811|NCT03365934|144736215|SUPERIORITY|||||||0.998744|||||||t-test, 2 sided|||||||0.998744
72603812|NCT03365934|144736216|SUPERIORITY|||||||0.999858|||||||t-test, 2 sided|||||||0.999858
72603813|NCT03365934|144736216|SUPERIORITY|||||||0.215132|||||||t-test, 2 sided|||||||0.215132
72603814|NCT03365934|144736216|SUPERIORITY|||||||0.958812|||||||t-test, 2 sided|||||||0.958812
72603815|NCT03365934|144736216|SUPERIORITY|||||||0.00622|||||||t-test, 2 sided|||||||0.00622
72603816|NCT03365934|144736216|SUPERIORITY|||||||0.017733|||||||t-test, 2 sided|||||||0.017733
72603817|NCT03365934|144736216|SUPERIORITY|||||||0.330576|||||||t-test, 2 sided|||||||0.330576
72603818|NCT03365934|144736216|SUPERIORITY|||||||0.990334|||||||t-test, 2 sided|||||||0.990334
72603819|NCT03365934|144736216|SUPERIORITY|||||||0.013025|||||||t-test, 2 sided|||||||0.013025
72603820|NCT03365934|144736216|SUPERIORITY|||||||0.034707|||||||t-test, 2 sided|||||||0.034707
72603821|NCT03365934|144736216|SUPERIORITY|||||||0.771698|||||||t-test, 2 sided|||||||0.771698
72603822|NCT03365934|144736216|SUPERIORITY|||||||0.790117|||||||t-test, 2 sided|||||||0.790117
72603823|NCT03365934|144736216|SUPERIORITY|||||||0.923224|||||||t-test, 2 sided|||||||0.923224
72603824|NCT03365934|144736216|SUPERIORITY|||||||0.112245|||||||t-test, 2 sided|||||||0.112245
72603825|NCT03365934|144736216|SUPERIORITY|||||||0.216229|||||||t-test, 2 sided|||||||0.216229
72603826|NCT03365934|144736216|SUPERIORITY|||||||0.999663|||||||t-test, 2 sided|||||||0.999663
72603827|NCT03365934|144736217|SUPERIORITY|||||||0.91874|||||||t-test, 2 sided|||||||0.91874
72603828|NCT03365934|144736217|SUPERIORITY|||||||0.013582|||||||t-test, 2 sided|||||||0.013582
72603829|NCT03365934|144736217|SUPERIORITY|||||||0.523284|||||||t-test, 2 sided|||||||0.523284
72603830|NCT03365934|144736217|SUPERIORITY|||||||0.000315|||||||t-test, 2 sided|||||||0.000315
72603831|NCT03365934|144736217|SUPERIORITY|||||||0.059485|||||||t-test, 2 sided|||||||0.059485
72603832|NCT03365934|144736217|SUPERIORITY|||||||0.15037|||||||t-test, 2 sided|||||||0.15037
72603833|NCT03365934|144736217|SUPERIORITY|||||||0.967277|||||||t-test, 2 sided|||||||0.967277
72603834|NCT03365934|144736217|SUPERIORITY|||||||0.008729|||||||t-test, 2 sided|||||||0.008729
72603835|NCT03365934|144736217|SUPERIORITY|||||||0.421603|||||||t-test, 2 sided|||||||0.421603
72603836|NCT03365934|144736217|SUPERIORITY|||||||0.647267|||||||t-test, 2 sided|||||||0.647267
72603837|NCT03365934|144736217|SUPERIORITY|||||||0.953645|||||||t-test, 2 sided|||||||0.953645
72603838|NCT03365934|144736217|SUPERIORITY|||||||0.987387|||||||t-test, 2 sided|||||||0.987387
72603839|NCT03365934|144736217|SUPERIORITY|||||||0.147361|||||||t-test, 2 sided|||||||0.147361
72603840|NCT03365934|144736217|SUPERIORITY|||||||0.930371|||||||t-test, 2 sided|||||||0.930371
72603841|NCT03365934|144736217|SUPERIORITY|||||||0.6094|||||||t-test, 2 sided|||||||0.6094
72603842|NCT03365934|144736218|SUPERIORITY|||||||0.99253|||||||t-test, 2 sided|||||||0.99253
72603843|NCT03365934|144736218|SUPERIORITY|||||||0.795279|||||||t-test, 2 sided|||||||0.795279
72603844|NCT03365934|144736218|SUPERIORITY|||||||0.855067|||||||t-test, 2 sided|||||||0.855067
72603845|NCT03365934|144736218|SUPERIORITY|||||||0.003915|||||||t-test, 2 sided|||||||0.003915
72603846|NCT03365934|144736218|SUPERIORITY|||||||0.000221|||||||t-test, 2 sided|||||||0.000221
72603847|NCT03365934|144736218|SUPERIORITY|||||||0.97816|||||||t-test, 2 sided|||||||0.97816
72603848|NCT03365934|144736218|SUPERIORITY|||||||0.98972|||||||t-test, 2 sided|||||||0.98972
72603849|NCT03365934|144736218|SUPERIORITY|||||||0.01764|||||||t-test, 2 sided|||||||0.01764
72603850|NCT03365934|144736218|SUPERIORITY|||||||0.001185|||||||t-test, 2 sided|||||||0.001185
72603851|NCT03365934|144736218|SUPERIORITY|||||||0.999999|||||||t-test, 2 sided|||||||0.999999
72603852|NCT03365934|144736218|SUPERIORITY|||||||0.119961|||||||t-test, 2 sided|||||||0.119961
72603853|NCT03365934|144736218|SUPERIORITY|||||||0.013468|||||||t-test, 2 sided|||||||0.013468
72603854|NCT03365934|144736218|SUPERIORITY|||||||0.112192|||||||t-test, 2 sided|||||||0.112192
72603855|NCT03365934|144736218|SUPERIORITY|||||||0.013135|||||||t-test, 2 sided|||||||0.013135
72603856|NCT03365934|144736218|SUPERIORITY|||||||0.965966|||||||t-test, 2 sided|||||||0.965966
72603857|NCT03365934|144736219|SUPERIORITY|||||||0.968005|||||||t-test, 2 sided|||||||0.968005
72603858|NCT03365934|144736219|SUPERIORITY|||||||0.526293|||||||t-test, 2 sided|||||||0.526293
72603859|NCT03365934|144736219|SUPERIORITY|||||||0.994384|||||||t-test, 2 sided|||||||0.994384
72603860|NCT03365934|144736219|SUPERIORITY|||||||0.004967|||||||t-test, 2 sided|||||||0.004967
72603861|NCT03365934|144736219|SUPERIORITY|||||||0.000948|||||||t-test, 2 sided|||||||0.000948
72603862|NCT03365934|144736219|SUPERIORITY|||||||0.936394|||||||t-test, 2 sided|||||||0.936394
72603863|NCT03365934|144736219|SUPERIORITY|||||||0.999945|||||||t-test, 2 sided|||||||0.999945
72603864|NCT03365934|144736219|SUPERIORITY|||||||0.050032|||||||t-test, 2 sided|||||||0.050032
72603865|NCT03365934|144736219|SUPERIORITY|||||||0.01256|||||||t-test, 2 sided|||||||0.01256
72603866|NCT03365934|144736219|SUPERIORITY|||||||0.886978|||||||t-test, 2 sided|||||||0.886978
72603867|NCT03365934|144736219|SUPERIORITY|||||||0.391295|||||||t-test, 2 sided|||||||0.391295
72603868|NCT03365934|144736219|SUPERIORITY|||||||0.163678|||||||t-test, 2 sided|||||||0.163678
72603869|NCT03365934|144736219|SUPERIORITY|||||||0.047937|||||||t-test, 2 sided|||||||0.047937
72603870|NCT03365934|144736219|SUPERIORITY|||||||0.013231|||||||t-test, 2 sided|||||||0.013231
72603871|NCT03365934|144736219|SUPERIORITY|||||||0.996358|||||||t-test, 2 sided|||||||0.996358
72603872|NCT03365934|144736220|SUPERIORITY|||||||0.995862|||||||t-test, 2 sided|||||||0.995862
72603873|NCT03365934|144736220|SUPERIORITY|||||||0.223341|||||||t-test, 2 sided|||||||0.223341
72603874|NCT03365934|144736220|SUPERIORITY|||||||0.834338|||||||t-test, 2 sided|||||||0.834338
72603875|NCT03365934|144736220|SUPERIORITY|||||||0.030267|||||||t-test, 2 sided|||||||0.030267
72603876|NCT03365934|144736220|SUPERIORITY|||||||0.00104|||||||t-test, 2 sided|||||||0.00104
72603877|NCT03365934|144736220|SUPERIORITY|||||||0.377217|||||||t-test, 2 sided|||||||0.377217
72603878|NCT03365934|144736220|SUPERIORITY|||||||0.965547|||||||t-test, 2 sided|||||||0.965547
72603879|NCT03365934|144736220|SUPERIORITY|||||||0.052284|||||||t-test, 2 sided|||||||0.052284
72603880|NCT03365934|144736220|SUPERIORITY|||||||0.001348|||||||t-test, 2 sided|||||||0.001348
72603881|NCT03365934|144736220|SUPERIORITY|||||||0.927936|||||||t-test, 2 sided|||||||0.927936
72603882|NCT03365934|144736220|SUPERIORITY|||||||0.946487|||||||t-test, 2 sided|||||||0.946487
72603883|NCT03365934|144736220|SUPERIORITY|||||||0.327918|||||||t-test, 2 sided|||||||0.327918
72603884|NCT03365934|144736220|SUPERIORITY|||||||0.475038|||||||t-test, 2 sided|||||||0.475038
72603885|NCT03365934|144736220|SUPERIORITY|||||||0.060057|||||||t-test, 2 sided|||||||0.060057
72603886|NCT03365934|144736220|SUPERIORITY|||||||0.857177|||||||t-test, 2 sided|||||||0.857177
72603887|NCT03365934|144736221|SUPERIORITY|||||||0.999997|||||||t-test, 2 sided|||||||0.999997
72603888|NCT03365934|144736221|SUPERIORITY|||||||0.938793|||||||t-test, 2 sided|||||||0.938793
72603889|NCT03365934|144736221|SUPERIORITY|||||||0.965993|||||||t-test, 2 sided|||||||0.965993
72603890|NCT03365934|144736221|SUPERIORITY|||||||0.057803|||||||t-test, 2 sided|||||||0.057803
72603891|NCT03365934|144736221|SUPERIORITY|||||||0.022816|||||||t-test, 2 sided|||||||0.022816
72603892|NCT03365934|144736221|SUPERIORITY|||||||0.945179|||||||t-test, 2 sided|||||||0.945179
72603893|NCT03365934|144736221|SUPERIORITY|||||||0.972522|||||||t-test, 2 sided|||||||0.972522
72603894|NCT03365934|144736221|SUPERIORITY|||||||0.033704|||||||t-test, 2 sided|||||||0.033704
72603895|NCT03365934|144736221|SUPERIORITY|||||||0.010747|||||||t-test, 2 sided|||||||0.010747
72603896|NCT03365934|144736221|SUPERIORITY|||||||0.999999|||||||t-test, 2 sided|||||||0.999999
72603897|NCT03365934|144736221|SUPERIORITY|||||||0.385474|||||||t-test, 2 sided|||||||0.385474
72603898|NCT03365934|144736221|SUPERIORITY|||||||0.213798|||||||t-test, 2 sided|||||||0.213798
72603899|NCT03365934|144736221|SUPERIORITY|||||||0.388682|||||||t-test, 2 sided|||||||0.388682
72603900|NCT03365934|144736221|SUPERIORITY|||||||0.22386|||||||t-test, 2 sided|||||||0.22386
72603901|NCT03365934|144736221|SUPERIORITY|||||||0.999494|||||||t-test, 2 sided|||||||0.999494
72603902|NCT03365934|144736222|SUPERIORITY|||||||0.891244|||||||t-test, 2 sided|||||||0.891244
72603903|NCT03365934|144736222|SUPERIORITY|||||||0.022659|||||||t-test, 2 sided|||||||0.022659
72603904|NCT03365934|144736222|SUPERIORITY|||||||0.693615|||||||t-test, 2 sided|||||||0.693615
72603905|NCT03365934|144736222|SUPERIORITY|||||||0.000237|||||||t-test, 2 sided|||||||0.000237
72603906|NCT03365934|144736222|SUPERIORITY|||||||5e-06|||||||t-test, 2 sided|||||||0.000005
72603907|NCT03365934|144736222|SUPERIORITY|||||||0.352008|||||||t-test, 2 sided|||||||0.352008
72603908|NCT03365934|144736222|SUPERIORITY|||||||0.998761|||||||t-test, 2 sided|||||||0.998761
72603909|NCT03365934|144736222|SUPERIORITY|||||||0.017832|||||||t-test, 2 sided|||||||0.017832
72603910|NCT03365934|144736222|SUPERIORITY|||||||0.000974|||||||t-test, 2 sided|||||||0.000974
72603911|NCT03365934|144736222|SUPERIORITY|||||||0.638238|||||||t-test, 2 sided|||||||0.638238
72603912|NCT03365934|144736222|SUPERIORITY|||||||0.777423|||||||t-test, 2 sided|||||||0.777423
72603913|NCT03365934|144736222|SUPERIORITY|||||||0.249909|||||||t-test, 2 sided|||||||0.249909
72603914|NCT03365934|144736222|SUPERIORITY|||||||0.068196|||||||t-test, 2 sided|||||||0.068196
72603915|NCT03365934|144736222|SUPERIORITY|||||||0.005786|||||||t-test, 2 sided|||||||0.005786
72603916|NCT03365934|144736222|SUPERIORITY|||||||0.954163|||||||t-test, 2 sided|||||||0.954163
72603917|NCT03365934|144736224|SUPERIORITY||Mean Difference (Net)|-7.5|STANDARD_ERROR_OF_MEAN|2.851||0.009|TWO_SIDED|95.0|-13.1279|-1.8688|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #1 group based on the change from baseline at Day 1||-1.8688|-13.1279|0.009
72603918|NCT03365934|144736224|SUPERIORITY||Mean Difference (Net)|-5.08|STANDARD_ERROR_OF_MEAN|2.851||0.077|TWO_SIDED|95.0|-10.7083|0.5508|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #2 group based on the change from baseline at Day 1||0.5508|-10.7083|0.077
72603919|NCT03365934|144736224|SUPERIORITY||Mean Difference (Net)|-2.41|STANDARD_ERROR_OF_MEAN|2.851||0.399|TWO_SIDED|95.0|-8.0399|3.2192|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #3 group based on the change from baseline at Day 1||3.2192|-8.0399|0.399
72603920|NCT03365934|144736224|SUPERIORITY||Mean Difference (Net)|0.72|STANDARD_ERROR_OF_MEAN|2.851||0.802|TWO_SIDED|95.0|-4.9144|6.3446|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #4 group based on the change from baseline at Day 1||6.3446|-4.9144|0.802
72603921|NCT03365934|144736225|SUPERIORITY||Mean Difference (Net)|-11.37|STANDARD_ERROR_OF_MEAN|3.038|<|0.001|TWO_SIDED|95.0|-17.3738|-5.3723|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #1 group based on the change from baseline at Day 2||-5.3723|-17.3738|<0.001
72603922|NCT03365934|144736225|SUPERIORITY||Mean Difference (Net)|-12.68|STANDARD_ERROR_OF_MEAN|3.038|<|0.001|TWO_SIDED|95.0|-18.6789|-6.6775|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #2 group based on the change from baseline at Day 2||-6.6775|-18.6789|<0.001
72603923|NCT03365934|144736225|SUPERIORITY||Mean Difference (Net)|-1.96|STANDARD_ERROR_OF_MEAN|3.038||0.521|TWO_SIDED|95.0|-7.9571|4.0444|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #3 group based on the change from baseline at Day 2||4.0444|-7.9571|0.521
72603924|NCT03365934|144736225|SUPERIORITY||Mean Difference (Net)|8.39|STANDARD_ERROR_OF_MEAN|3.038||0.006|TWO_SIDED|95.0|2.3925|14.394|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #4 group based on the change from baseline at Day 2||14.3940|2.3925|0.006
72603925|NCT03365934|144736226|SUPERIORITY||Mean Difference (Net)|-31.83|STANDARD_ERROR_OF_MEAN|4.847|<|0.001|TWO_SIDED|95.0|-41.3967|-22.2538|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #1 group based on the change from baseline at Day 3||-22.2538|-41.3967|<0.001
72603926|NCT03365934|144736226|SUPERIORITY||Mean Difference (Net)|-27.3|STANDARD_ERROR_OF_MEAN|4.847|<|0.001|TWO_SIDED|95.0|-36.8727|-17.7298|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #2 group based on the change from baseline at Day 3||-17.7298|-36.8727|<0.001
72603927|NCT03365934|144736226|SUPERIORITY||Mean Difference (Net)|-13.71|STANDARD_ERROR_OF_MEAN|4.847||0.005|TWO_SIDED|95.0|-23.2784|-4.1355|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #3 group based on the change from baseline at Day 3||-4.1355|-23.2784|0.005
72603928|NCT03365934|144736226|SUPERIORITY||Mean Difference (Net)|10.07|STANDARD_ERROR_OF_MEAN|4.847||0.039|TWO_SIDED|95.0|0.4969|19.6398|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #4 group based on the change from baseline at Day 3||19.6398|0.4969|0.039
72603929|NCT03365934|144736227|SUPERIORITY||Mean Difference (Net)|-40.39|STANDARD_ERROR_OF_MEAN|5.39|<|0.001|TWO_SIDED|95.0|-51.0324|-29.7496|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #1 group based on the change from baseline at Day 4||-29.7496|-51.0324|<0.001
72603930|NCT03365934|144736227|SUPERIORITY||Mean Difference (Net)|-37.84|STANDARD_ERROR_OF_MEAN|5.39|<|0.001|TWO_SIDED|95.0|-48.4787|-27.1959|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #2 group based on the change from baseline at Day 4||-27.1959|-48.4787|<0.001
72603931|NCT03365934|144736227|SUPERIORITY||Mean Difference (Net)|-20.99|STANDARD_ERROR_OF_MEAN|5.39|<|0.001|TWO_SIDED|95.0|-31.6336|-10.3508|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #3 group based on the change from baseline at Day 4||-10.3508|-31.6336|<0.001
72603932|NCT03365934|144736227|SUPERIORITY||Mean Difference (Net)|8.75|STANDARD_ERROR_OF_MEAN|5.39||0.106|TWO_SIDED|95.0|-1.8871|19.3957|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #4 group based on the change from baseline at Day 4||19.3957|-1.8871|0.106
72603933|NCT03365934|144736228|SUPERIORITY||Mean Difference (Net)|-32.9|STANDARD_ERROR_OF_MEAN|5.276|<|0.001|TWO_SIDED|95.0|-43.3249|-22.4838|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #1 group based on the change from baseline at Day 5||-22.4838|-43.3249|<0.001
72603934|NCT03365934|144736228|SUPERIORITY||Mean Difference (Net)|-27.31|STANDARD_ERROR_OF_MEAN|5.276|<|0.001|TWO_SIDED|95.0|-37.7279|-16.8868|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #2 group based on the change from baseline at Day 5||-16.8868|-37.7279|<0.001
72603935|NCT03365934|144736228|SUPERIORITY||Mean Difference (Net)|-18.76|STANDARD_ERROR_OF_MEAN|5.276|<|0.001|TWO_SIDED|95.0|-29.1785|-8.3374|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #3 group based on the change from baseline at Day 5||-8.3374|-29.1785|<0.001
72603936|NCT03365934|144736228|SUPERIORITY||Mean Difference (Net)|6.79|STANDARD_ERROR_OF_MEAN|5.276||0.2|TWO_SIDED|95.0|-3.6303|17.2107|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #4 group based on the change from baseline at Day 5||17.2107|-3.6303|0.200
72603937|NCT03365934|144736229|SUPERIORITY||Mean Difference (Net)|-30.9|STANDARD_ERROR_OF_MEAN|4.371|<|0.001|TWO_SIDED|95.0|-39.5325|-22.265|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #1 group based on the change from baseline at Day 6||-22.2650|-39.5325|<0.001
72603938|NCT03365934|144736229|SUPERIORITY||Mean Difference (Net)|-25.33|STANDARD_ERROR_OF_MEAN|4.371|<|0.001|TWO_SIDED|95.0|-33.9669|-16.6993|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #2 group based on the change from baseline at Day 6||-16.6993|-33.9669|<0.001
72603939|NCT03365934|144736229|SUPERIORITY||Mean Difference (Net)|-20.63|STANDARD_ERROR_OF_MEAN|4.371|<|0.001|TWO_SIDED|95.0|-29.2588|-11.9912|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #3 group based on the change from baseline at Day 6||-11.9912|-29.2588|<0.001
72603940|NCT03365934|144736229|SUPERIORITY||Mean Difference (Net)|4.27|STANDARD_ERROR_OF_MEAN|4.371||0.33|TWO_SIDED|95.0|-4.362|12.9055|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #4 group based on the change from baseline at Day 6||12.9055|-4.3620|0.330
72603941|NCT03365934|144736230|SUPERIORITY||Mean Difference (Net)|-13.95|STANDARD_ERROR_OF_MEAN|3.754|<|0.001|TWO_SIDED|95.0|-21.368|-6.5419|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #1 group based on the change from baseline at Day 7||-6.5419|-21.3680|<0.001
72603942|NCT03365934|144736230|SUPERIORITY||Mean Difference (Net)|-11.54|STANDARD_ERROR_OF_MEAN|3.754||0.002|TWO_SIDED|95.0|-18.9563|-4.1302|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #2 group based on the change from baseline at Day 7||-4.1302|-18.9563|0.002
72603943|NCT03365934|144736230|SUPERIORITY||Mean Difference (Net)|-10.07|STANDARD_ERROR_OF_MEAN|3.754||0.008|TWO_SIDED|95.0|-17.4867|-2.6606|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #3 group based on the change from baseline at Day 7||-2.6606|-17.4867|0.008
72603944|NCT03365934|144736230|SUPERIORITY||Mean Difference (Net)|6.87|STANDARD_ERROR_OF_MEAN|3.754||0.069|TWO_SIDED|95.0|-0.5447|14.2814|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #4 group based on the change from baseline at Day 7||14.2814|-0.5447|0.069
72603945|NCT03365934|144736231|SUPERIORITY||Mean Difference (Net)|-2.76|STANDARD_ERROR_OF_MEAN|3.244||0.397|TWO_SIDED|95.0|-9.1631|3.6504|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #1 group based on the change from baseline at Day 14||3.6504|-9.1631|0.397
72603946|NCT03365934|144736231|SUPERIORITY||Mean Difference (Net)|0.81|STANDARD_ERROR_OF_MEAN|3.244||0.804|TWO_SIDED|95.0|-5.6006|7.2129|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #2 group based on the change from baseline at Day 14||7.2129|-5.6006|0.804
72603947|NCT03365934|144736231|SUPERIORITY||Mean Difference (Net)|-9.32|STANDARD_ERROR_OF_MEAN|3.244||0.005|TWO_SIDED|95.0|-15.7231|-2.9096|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #3 group based on the change from baseline at Day 14||-2.9096|-15.7231|0.005
72603948|NCT03365934|144736231|SUPERIORITY||Mean Difference (Net)|0.06|STANDARD_ERROR_OF_MEAN|3.244||0.985|TWO_SIDED|95.0|-6.3452|6.4683|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #4 group based on the change from baseline at Day 14||6.4683|-6.3452|0.985
72603949|NCT03365934|144736233|SUPERIORITY||Mean Difference (Net)|-0.04|STANDARD_ERROR_OF_MEAN|0.044||0.348|TWO_SIDED|95.0|-0.129|0.0458|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #1 group based on the change from baseline at Day 1||0.0458|-0.1290|0.348
72603950|NCT03365934|144736233|SUPERIORITY||Mean Difference (Net)|-0.1|STANDARD_ERROR_OF_MEAN|0.044||0.019|TWO_SIDED|95.0|-0.1904|-0.0178|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #2 group based on the change from baseline at Day 1||-0.0178|-0.1904|0.019
72603951|NCT03365934|144736233|SUPERIORITY||Mean Difference (Net)|-0.06|STANDARD_ERROR_OF_MEAN|0.043||0.183|TWO_SIDED|95.0|-0.1437|0.0278|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #3 group based on the change from baseline at Day 1||0.0278|-0.1437|0.183
72603952|NCT03365934|144736233|SUPERIORITY||Mean Difference (Net)|0.01|STANDARD_ERROR_OF_MEAN|0.044||0.736|TWO_SIDED|95.0|-0.0725|0.1023|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #4 group based on the change from baseline at Day 1||0.1023|-0.0725|0.736
72603953|NCT03365934|144736234|SUPERIORITY||Mean Difference (Net)|-0.03|STANDARD_ERROR_OF_MEAN|0.052||0.516|TWO_SIDED|95.0|-0.136|0.0687|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #1 group based on the change from baseline at Day 2||0.0687|-0.1360|0.516
72603954|NCT03365934|144736234|SUPERIORITY||Mean Difference (Net)|-0.14|STANDARD_ERROR_OF_MEAN|0.052||0.006|TWO_SIDED|95.0|-0.2459|-0.0412|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #2 group based on the change from baseline at Day 2||-0.0412|-0.2459|0.006
72603955|NCT03365934|144736234|SUPERIORITY||Mean Difference (Net)|-0.02|STANDARD_ERROR_OF_MEAN|0.051||0.671|TWO_SIDED|95.0|-0.1235|0.0798|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #3 group based on the change from baseline at Day 2||0.0798|-0.1235|0.671
72603956|NCT03365934|144736234|SUPERIORITY||Mean Difference (Net)|0.15|STANDARD_ERROR_OF_MEAN|0.052||0.004|TWO_SIDED|95.0|0.0504|0.2578|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #4 group based on the change from baseline at Day 2||0.2578|0.0504|0.004
72603957|NCT03365934|144736235|SUPERIORITY||Mean Difference (Net)|-0.07|STANDARD_ERROR_OF_MEAN|0.062||0.292|TWO_SIDED|95.0|-0.1896|0.0579|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #1 group based on the change from baseline at Day 3||0.0579|-0.1896|0.292
72603958|NCT03365934|144736235|SUPERIORITY||Mean Difference (Net)|-0.15|STANDARD_ERROR_OF_MEAN|0.062||0.016|TWO_SIDED|95.0|-0.2773|-0.0297|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #2 group based on the change from baseline at Day 3||-0.0297|-0.2773|0.016
72603959|NCT03365934|144736235|SUPERIORITY||Mean Difference (Net)|-0.04|STANDARD_ERROR_OF_MEAN|0.062||0.538|TWO_SIDED|95.0|-0.1622|0.0853|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #3 group based on the change from baseline at Day 3||0.0853|-0.1622|0.538
72603960|NCT03365934|144736235|SUPERIORITY||Mean Difference (Net)|0.012|STANDARD_ERROR_OF_MEAN|0.065||0.061|TWO_SIDED|95.0|-0.0059|0.2515|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #4 group based on the change from baseline at Day 3||0.2515|-0.0059|0.061
72603961|NCT03365934|144736236|SUPERIORITY||Mean Difference (Net)|-0.21|STANDARD_ERROR_OF_MEAN|0.06||0.001|TWO_SIDED|95.0|-0.3265|-0.0895|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #1 group based on the change from baseline at Day 4||-0.0895|-0.3265|0.001
72603962|NCT03365934|144736236|SUPERIORITY||Mean Difference (Net)|-0.24|STANDARD_ERROR_OF_MEAN|0.06|<|0.001|TWO_SIDED|95.0|-0.3614|-0.1243|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #2 group based on the change from baseline at Day 4||-0.1243|-0.3614|<0.001
72603963|NCT03365934|144736236|SUPERIORITY||Mean Difference (Net)|-0.07|STANDARD_ERROR_OF_MEAN|0.06||0.236|TWO_SIDED|95.0|-0.1899|0.0471|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #3 group based on the change from baseline at Day 4||0.0471|-0.1899|0.236
72603964|NCT03365934|144736236|SUPERIORITY||Mean Difference (Net)|0.03|STANDARD_ERROR_OF_MEAN|0.061||0.627|TWO_SIDED|95.0|-0.0902|0.1492|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #4 group based on the change from baseline at Day 4||0.1492|-0.0902|0.627
72603965|NCT03365934|144736237|SUPERIORITY||Mean Difference (Net)|-0.23|STANDARD_ERROR_OF_MEAN|0.051|<|0.001|TWO_SIDED|95.0|-0.3331|-0.1305|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #1 group based on the change from baseline at Day 5||-0.1305|-0.3331|<0.001
72416251|NCT01972841|144343306|SUPERIORITY||Least squares mean difference|-1.62|STANDARD_ERROR_OF_MEAN|0.76||0.034|TWO_SIDED|95.0|-3.1|-0.13|||Stratified rank ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (solifenacin 5 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||-0.13|-3.10|0.034
72603966|NCT03365934|144736237|SUPERIORITY||Mean Difference (Net)|-0.21|STANDARD_ERROR_OF_MEAN|0.05|<|0.001|TWO_SIDED|95.0|-0.3091|-0.1092|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #2 group based on the change from baseline at Day 5||-0.1092|-0.3091|<0.001
72603967|NCT03365934|144736237|SUPERIORITY||Mean Difference (Net)|-0.14|STANDARD_ERROR_OF_MEAN|0.05||0.005|TWO_SIDED|95.0|-0.2439|-0.0457|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #3 group based on the change from baseline at Day 5||-0.0457|-0.2439|0.005
72603968|NCT03365934|144736237|SUPERIORITY||Mean Difference (Net)|0.12|STANDARD_ERROR_OF_MEAN|0.052||0.02|TWO_SIDED|95.0|0.0197|0.2252|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #4 group based on the change from baseline at Day 5||0.2252|0.0197|0.020
72603969|NCT03365934|144736238|SUPERIORITY||Mean Difference (Net)|-0.3|STANDARD_ERROR_OF_MEAN|0.05|<|0.001|TWO_SIDED|95.0|-0.4019|-0.2044|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #1 group based on the change from baseline at Day 6||-0.2044|-0.4019|<0.001
72603970|NCT03365934|144736238|SUPERIORITY||Mean Difference (Net)|-0.27|STANDARD_ERROR_OF_MEAN|0.05|<|0.001|TWO_SIDED|95.0|-0.3655|-0.1679|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #2 group based on the change from baseline at Day 6||-0.1679|-0.3655|<0.001
72603971|NCT03365934|144736238|SUPERIORITY||Mean Difference (Net)|-0.24|STANDARD_ERROR_OF_MEAN|0.05|<|0.001|TWO_SIDED|95.0|-0.3338|-0.1377|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #3 group based on the change from baseline at Day 6||-0.1377|-0.3338|<0.001
72603972|NCT03365934|144736238|SUPERIORITY||Mean Difference (Net)|0.02|STANDARD_ERROR_OF_MEAN|0.05||0.646|TWO_SIDED|95.0|-0.0767|0.1231|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #4 group based on the change from baseline at Day 6||0.1231|-0.0767|0.646
72603973|NCT03365934|144736239|SUPERIORITY||Mean Difference (Net)|-0.13|STANDARD_ERROR_OF_MEAN|0.047||0.006|TWO_SIDED|95.0|-0.2254|-0.0384|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #1 group based on the change from baseline at Day 7||-0.0384|-0.2254|0.006
72603974|NCT03365934|144736239|SUPERIORITY||Mean Difference (Net)|-0.15|STANDARD_ERROR_OF_MEAN|0.047||0.002|TWO_SIDED|95.0|-0.2444|-0.0574|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #2 group based on the change from baseline at Day 7||-0.0574|-0.2444|0.002
72603975|NCT03365934|144736239|SUPERIORITY||Mean Difference (Net)|-0.16|STANDARD_ERROR_OF_MEAN|0.047||0.001|TWO_SIDED|95.0|-0.2541|-0.0682|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #3 group based on the change from baseline at Day 7||-0.0682|-0.2541|0.001
72603976|NCT03365934|144736239|SUPERIORITY||Mean Difference (Net)|0.01|STANDARD_ERROR_OF_MEAN|0.048||0.911|TWO_SIDED|95.0|-0.0891|0.0998|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #4 group based on the change from baseline at Day 7||0.0998|-0.0891|0.911
72603977|NCT03365934|144736240|SUPERIORITY||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|0.04||0.937|TWO_SIDED|95.0|-0.0818|0.0755|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #1 group based on the change from baseline at Day 14||0.0755|-0.0818|0.937
72603978|NCT03365934|144736240|SUPERIORITY||Mean Difference (Net)|-0.09|STANDARD_ERROR_OF_MEAN|0.039||0.026|TWO_SIDED|95.0|-0.1663|-0.0108|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #2 group based on the change from baseline at Day 14||-0.0108|-0.1663|0.026
72603979|NCT03365934|144736240|SUPERIORITY||Mean Difference (Net)|-0.08|STANDARD_ERROR_OF_MEAN|0.039||0.045|TWO_SIDED|95.0|-0.1562|-0.0017|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #3 group based on the change from baseline at Day 14||-0.0017|-0.1562|0.045
72603980|NCT03365934|144736240|SUPERIORITY||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|0.039||0.956|TWO_SIDED|95.0|-0.0799|0.0755|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #4 group based on the change from baseline at Day 14||0.0755|-0.0799|0.956
72603981|NCT04194489|144736241|OTHER|Effect size calculation|Cohen's d|0.43|||||TWO_SIDED|||||||||Cohen's d effect size was calculated using baseline and follow-up means and standard deviations. An effect size of 0.2 is small, 0.5 is medium and 0.8 is large.||||
72603982|NCT04194489|144736242|OTHER|Effect size|Cohen's d|0.17|||||TWO_SIDED|||||||||Cohen's d effect size was calculated using baseline and follow-up means and standard deviations. An effect size of 0.2 is small, 0.5 is medium and 0.8 is large.||||
72603983|NCT04194489|144736243|OTHER|Effect size calculation|Cohen's d|0.27|||||TWO_SIDED|||||||||Cohen's d effect size was calculated using baseline and follow-up means and standard deviations. An effect size of 0.2 is small, 0.5 is medium and 0.8 is large.||||
72603984|NCT04194489|144736244|OTHER|Effect size calculation|Cohen's d|0.02|||||TWO_SIDED|||||||||Cohen's d effect size was calculated using baseline and follow-up means and standard deviations. An effect size of 0.2 is small, 0.5 is medium and 0.8 is large.||||
72603985|NCT00522548|144736255|SUPERIORITY|||||||0.29||||||A p value of less than 0.05 was considered statistically significant.|Fisher Exact|||Sample size was arbitrarily determined as 40 patients (20 in the CellCept group and 20 in the Myfortic group) in this proof of concept study||||.29
72603986|NCT00522548|144736256|SUPERIORITY_OR_OTHER|||||||0.39|TWO_SIDED|95.0||||A p value of less than 0.05 was considered statistically significant.|Fisher Exact|||Sample size was arbitrarily determined as 40 patients (20 in the CellCept group and 20 in the Myfortic group) in this proof of concept study||||0.39
72603987|NCT00522548|144736257|SUPERIORITY|||||||1||||||A p value of less than 0.05 was considered statistically significant.|Fisher Exact|||Sample size was arbitrarily determined as 40 patients (20 in the CellCept group and 20 in the Myfortic group) in this proof of concept study||||1.0
72603988|NCT00522548|144736258|SUPERIORITY|||||||1||||||A p value of less than 0.05 was considered significant.|Fisher Exact|||Sample size was arbitrarily determined as 40 patients (20 in the CellCept group and 20 in the Myfortic group) in this proof of concept study||||1.00
72603989|NCT00522548|144736259|SUPERIORITY|||||||0.14||||||a p value of less than 0.05 was considered statistically significant|Fisher Exact|||Sample size was arbitrarily determined as 40 patients (20 in the CellCept group and 20 in the Myfortic group) in this proof of concept study||||0.14
72603990|NCT00522548|144736260|SUPERIORITY|||||||0.34||||||A p value of less than 0.05 was considered statistically significant.|Chi-squared|||Sample size was arbitrarily determined as 40 patients (20 in the CellCept group and 20 in the Myfortic group) in this proof of concept study||||0.34
72603991|NCT00522548|144736261|SUPERIORITY_OR_OTHER|||||||0.51||||||A p-value of less than 0.05 was considered statistically significant.|Fisher Exact|||Sample size was arbitrarily determined as 40 patients (20 in the CellCept group and 20 in the Myfortic group) in this proof of concept study||||.51
72603992|NCT00522548|144736262|SUPERIORITY|||||||0.95|TWO_SIDED|95.0||||A p-value of less than 0.05 was considered statistically significant.|t-test, 2 sided|||Sample size was arbitrarily determined as 40 patients (20 in the CellCept group and 20 in the Myfortic group) in this proof of concept study.||||0.95
72603993|NCT00522548|144736263|SUPERIORITY|||||||0.57||||||The p value was not adjusted for multiple comparisons. A p-value of less than 0.05 was considered statistically significant.|t-test, 2 sided|||Sample size was arbitrarily determined as 40 patients (20 in the CellCept group and 20 in the Myfortic group) in this proof of concept study.||||0.57
72603994|NCT00522548|144736264|SUPERIORITY|||||||0.45|TWO_SIDED|95.0||||This represents p value for week 4 data. A p value of less than 0.05 was considered significant.|Kruskal-Wallis|||Sample size was arbitrarily determined as 40 patients (20 in the CellCept group and 20 in the Myfortic group) in this proof of concept study||||0.45
72603995|NCT00522548|144736264|SUPERIORITY|||||||0.58|TWO_SIDED|95.0||||This represents p value for week 24 data. A p value of less than 0.05 was considered significant.|Kruskal-Wallis|||Sample size was arbitrarily determined as 40 patients (20 in CellCept group and 20 in the Myfortic group) in this proof of concept study.||||0.58
72603996|NCT00522548|144736265|SUPERIORITY|||||||0.012||||||This p value is for data at week 4. A p value of less than 0.05 was considered significant.|Kruskal-Wallis|||Sample size was arbitrarily determined as 40 patients (20 in the CellCept group and 20 in the Myfortic group) in this proof of concept study||||0.012
72603997|NCT00522548|144736265|SUPERIORITY|||||||0.046|TWO_SIDED|95.0||||This p value was for data at week 24. A p value of less than 0.05 was considered significant.|Kruskal-Wallis|||sample size was arbitrarily determined as 40 patients (20 in the CellCept group and 20 in the Myfortic Group) in this proof of concept study.||||0.046
72603998|NCT00522548|144736266|SUPERIORITY|||||||0.27||||||p value represents data for week 4. A p value of less than 0.05 was considered significant.|Kruskal-Wallis|||Sample size was arbitrarily determined as 40 patients (20 in the CellCept group and 20 in the Myfortic group) in this proof of concept study||||0.27
72603999|NCT00522548|144736266|SUPERIORITY|||||||0.23|TWO_SIDED|95.0||||p value represents data for week 24. A p value of less than 0.05 was considered significant.|Kruskal-Wallis|||Sample size was arbitrarily determined as 40 patients (20 in the CellCept group and 20 in the Myfortic group) in this proof of concept study||||0.23
72604000|NCT02121795|144736267|NON_INFERIORITY|Noninferiority was assessed using a conventional 95.002% confidence interval (CI) approach, with a noninferiority margin of 10%.|Percentage difference|1.3||||0.5|TWO_SIDED|95.002|-2.5|5.1|||Cochran-Mantel-Haenszel|P-value was from Cochran-Mantel-Haenszel (CMH) test stratified by third agent.|Difference in percentages of virologic success between treatment groups and its 95.002% CI were calculated based on the Mantel-Haenszel (MH) proportions adjusted by the third agent stratum.|||5.1|-2.5|0.5
72604001|NCT02363387|144736284|SUPERIORITY||Odds Ratio (OR)|7.1|||<|0.001|TWO_SIDED|95.0|2.7|18.8|||Regression, Logistic|||||18.8|2.7|<0.001
72604002|NCT02609386|144736291|OTHER||Cox Proportional Hazard|1.102||||0.6176|TWO_SIDED|95.0|0.6|2.1|||Log Rank|||||2.1|0.6|0.6176
72604003|NCT02609386|144736292|OTHER||Cox Proportional Hazard|1.009||||0.3889|TWO_SIDED|95.0|0.5|2.2|||Log Rank|||||2.2|0.5|0.3889
72604004|NCT02609386|144736293|OTHER||Cox Proportional Hazard|1.009||||0.5091|TWO_SIDED|95.0|0.5|2.2|||Log Rank|||||2.2|0.5|0.5091
72604005|NCT04391179|144736309|SUPERIORITY||Slope|-0.033|STANDARD_ERROR_OF_MEAN|0.027||0.24|TWO_SIDED|95.0|-0.089|0.023|||Mixed Models Analysis||Estimation represents log-scale difference between average daily change in D-Dimer for Dipyridamole patients minus placebo average daily change. Negative estimates indicate that D-Dimer levels decline faster in Dipyridamole versus placebo patients.|||.023|-.089|0.24
72604006|NCT04391179|144736310|SUPERIORITY||win ratio|1.0||||0.98|TWO_SIDED|97.8|0.78|1.29|||Mantel Haenszel||win ratio= (the probability of a win for the dipyridamole patient)/(probability of a win for the placebo patient)|A win ratio analysis of the hierarchical composite outcome requiring direct comparison of outcomes between each dipyridamole patient and placebo patient. The patient with the superior outcome is adjudicated the 'winner' and receives a +1 score, while the 'loser' scores -1.||1.29|0.78|.98
72604007|NCT04391179|144736311|SUPERIORITY|||||||0.08|||||||Wilcoxon (Mann-Whitney)|||||||.08
72604008|NCT04391179|144736312|SUPERIORITY|||||||0.09|||||||Log Rank|||||||.09
72604009|NCT04391179|144736313|SUPERIORITY||Mean Difference (Net)|0.29||||0.36|TWO_SIDED|95.0|0.02|3.94|||regression, negative binomial||estimated ratio of days on mechanical ventilation for dipyridamole and placebo|||3.94|0.02|0.36
72604010|NCT04391179|144736314|SUPERIORITY||Odds Ratio (OR)|1.04||||0.94|TWO_SIDED|95.0|0.43|2.51|||Regression, Logistic||Odds of a 50 point drop in the dipyridamole group relative to the placebo group.|||2.51|0.43|.94
72604011|NCT04391179|144736315|SUPERIORITY|||||||0.95|||||||Wilcoxon (Mann-Whitney)|||||||.95
72604012|NCT03442088|144736347|OTHER||Mean Difference (Final Values)|-0.272||||0.0001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.0001
72604013|NCT03442088|144736348|OTHER||Mean Difference (Final Values)|95.98||||0.934|TWO_SIDED|95.0|-2324.0|2516.0|||t-test, 2 sided|||||2516|-2324|0.934
72604014|NCT03442088|144736349|OTHER||Mean Difference (Final Values)|-0.6878||||0.1632|TWO_SIDED|95.0|-1.685|0.3097|||t-test, 2 sided|||||0.3097|-1.685|0.1632
72604015|NCT03442088|144736350|OTHER||Mean Difference (Final Values)|-2.344||||0.1063|TWO_SIDED|95.0|-5.248|0.5992|||t-test, 2 sided|||||0.5992|-5.248|0.1063
72604016|NCT03442088|144736351|OTHER||Mean Difference (Final Values)|3.24||||0.5611|TWO_SIDED|95.0|-8.333|14.81|||t-test, 2 sided|||||14.81|-8.333|0.5611
72604017|NCT00105989|144736356|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||No adjustments were made for multiple comparisons. The primary efficacy analysis compared the time to recurrence during the maintenance phase between all duloxetine and placebo patients using the log-rank test, stratified by country at α=.05.|Log Rank|The log rank method provides a single p-value comparing time to depressive recurrence for placebo and duloxetine.||A total of 257 randomized patients (randomly assigned with equal probability to the two treatment groups) were needed to have 90% power to detect 40% versus 20% recurrence rates over 52 weeks, using a log rank test at a two-sided significance level of .05.||||<0.001
72604018|NCT00105989|144736357|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel|Frequencies are analyzed using Cochran-Mantel-Haenszel controlling for investigator||||||<0.001
72604019|NCT00105989|144736358|SUPERIORITY_OR_OTHER|||||||0.003||95.0|||||Log Rank|The log rank method provides a single p-value comparing time to depressive recurrence for placebo and duloxetine.||||||0.003
72604020|NCT00105989|144736359|SUPERIORITY_OR_OTHER|||||||0.003||95.0|||||Cochran-Mantel-Haenszel|Frequencies were analyzed using Cochran-Mantel-Haenszel controlling for investigator.||||||0.003
72604021|NCT00105989|144736360|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||<0.001
72604022|NCT00105989|144736360|SUPERIORITY_OR_OTHER|||||||0.016||95.0|||||t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.016
72604023|NCT00105989|144736361|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||||||<0.001
72604024|NCT00105989|144736362|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||<0.001
72604025|NCT00105989|144736362|SUPERIORITY_OR_OTHER|||||||0.153||95.0|||||t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.153
72604026|NCT00105989|144736363|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||||||<0.001
72604027|NCT00105989|144736364|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|t-test assesses if within treatment mean value at endpoint is significant from 4.||||||<0.001
72604028|NCT00105989|144736364|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|t-test assesses if within treatment mean value at endpoint is significant from 4.||||||<0.001
72604029|NCT00105989|144736365|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||||||<0.001
72604030|NCT00105989|144736366|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values for Change from Baseline to Endpoint for all Subscales during Acute phase were \<0.001.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||<0.001
72604031|NCT00105989|144736366|SUPERIORITY_OR_OTHER|||||||0.334||95.0||||P-value for Anxiety Change from Baseline to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.334
72604032|NCT00105989|144736366|SUPERIORITY_OR_OTHER|||||||0.019||95.0||||P-value for Core Change from Baseline to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.019
72604033|NCT00105989|144736366|SUPERIORITY_OR_OTHER|||||||0.046||95.0||||P-value for Maier Change from Baseline to Endpoint.|t-test, 2 sided|t-test assessses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.046
72604034|NCT00105989|144736366|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Retardation Change from Baseline to Endpoint.|t-test, 2 sided|t-test assessses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||<0.001
72604035|NCT00105989|144736366|SUPERIORITY_OR_OTHER|||||||0.319||95.0||||P-value for Sleep Change from Baseline to Endpoint.|t-test, 2 sided|t-test assessses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.319
72604036|NCT00105989|144736366|SUPERIORITY_OR_OTHER|||||||0.275||95.0||||P-value for Depressed Mood Change from Baseline to Endpoint.|t-test, 2 sided|t-test assessses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.275
72604037|NCT00105989|144736367|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Pairwise comparison of Least Squares Means for Anxiety Subscale Change from Baseline to Endpoint.|t-test, 2 sided|||||||<0.001
72604038|NCT00105989|144736367|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||P-value for Pairwise comparison of Least Squares Means for Core Subscale Change from Baseline to Endpoint.|t-test, 2 sided|||||||0.002
72604039|NCT00105989|144736367|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||P-value for Pairwise comparison of Least Squares Means for Maier Subscale Change from Baseline to Endpoint.|t-test, 2 sided|||||||0.002
72604040|NCT00105989|144736367|SUPERIORITY_OR_OTHER|||||||0.003||95.0||||P-value for Pairwise comparison of Least Squares Means for Retardation Subscale Change from Baseline to Endpoint.|t-test, 2 sided|||||||0.003
72604041|NCT00105989|144736367|SUPERIORITY_OR_OTHER|||||||0.001||95.0||||P-value for Pairwise comparison of Least Squares Means for Sleep Subscale Change from Baseline to Endpoint.|t-test, 2 sided|||||||0.001
72604042|NCT00105989|144736367|SUPERIORITY_OR_OTHER|||||||0.003||95.0||||P-value for Pairwise comparison of Least Squares Means for Depressed Mood Subscale Change from Baseline to Endpoint.|t-test, 2 sided|||||||0.003
72604043|NCT00105989|144736368|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for all Change from Baseline to Endpoint measures in the Acute Phase were \<0.001.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||<0.001
72604044|NCT00105989|144736368|SUPERIORITY_OR_OTHER|||||||0.273||95.0||||P-value for Overall Pain Change from Baseline to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.273
72604045|NCT00105989|144736368|SUPERIORITY_OR_OTHER|||||||0.968||95.0||||P-value for Headache Change from Baseline to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.968
72604046|NCT00105989|144736368|SUPERIORITY_OR_OTHER|||||||0.998||95.0||||P-value for Back Pain Change from Baseline to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.998
72604047|NCT00105989|144736368|SUPERIORITY_OR_OTHER|||||||0.703||95.0||||P-value for Shoulder Pain Change from Baseline to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.703
72604048|NCT00105989|144736368|SUPERIORITY_OR_OTHER|||||||0.346||95.0||||P-value for Interference with Daily Activities Change from Baseline to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.346
72604049|NCT00105989|144736368|SUPERIORITY_OR_OTHER|||||||0.963||95.0||||P-value for Pain While Awake Change from Baseline to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.963
72604050|NCT00105989|144736369|SUPERIORITY_OR_OTHER|||||||0.792||95.0||||P-value for pairwise comparison of Least Squares Means for Overall Pain Change from Baseline to Endpoint.|t-test, 2 sided|||||||0.792
72604051|NCT00105989|144736369|SUPERIORITY_OR_OTHER|||||||0.407||95.0||||P-value for pairwise comparison of Least Squares Means for Headache Change from Baseline to Endpoint.|t-test, 2 sided|||||||0.407
72604052|NCT00105989|144736369|SUPERIORITY_OR_OTHER|||||||0.475||95.0||||P-value for pairwise comparison of Least Squares Means for Back Pain Change from Baseline to Endpoint.|t-test, 2 sided|||||||0.475
72604053|NCT00105989|144736369|SUPERIORITY_OR_OTHER|||||||0.241||95.0||||P-value for pairwise comparison of Least Squares Means for Shoulder Pain Change from Baseline to Endpoint.|t-test, 2 sided|||||||0.241
72604054|NCT00105989|144736369|SUPERIORITY_OR_OTHER|||||||0.885||95.0||||P-value for pairwise comparison of Least Squares Means for Interference with Daily Activities Change from Baseline to Endpoint.|t-test, 2 sided|||||||0.885
72604055|NCT00105989|144736369|SUPERIORITY_OR_OTHER|||||||0.717||95.0||||P-value for pairwise comparison of Least Squares Means for Pain While Awake Change from Baseline to Endpoint.|t-test, 2 sided|||||||0.717
72604056|NCT00105989|144736370|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Change from Baseline to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||<0.001
72604057|NCT00105989|144736370|SUPERIORITY_OR_OTHER|||||||0.157||95.0||||P-value for Change from Baseline to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.157
72604058|NCT00105989|144736371|SUPERIORITY_OR_OTHER|||||||0.979||95.0|||||t-test, 2 sided|||||||0.979
72604059|NCT00105989|144736372|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Change from Baseline to Endpoint in all SDS items in Acute Phase were \<0.001.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||<0.001
72604060|NCT00105989|144736372|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Change from Baseline to Endpoint in all SDS items in the Continuation Phase were \<0.001.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||<0.001
72604061|NCT00105989|144736373|SUPERIORITY_OR_OTHER|||||||0.029||95.0||||P-value for pairwise comparison of Least Squares Means for Change from Baseline to Endpoint in Global Score|t-test, 2 sided|||||||0.029
72604062|NCT00105989|144736373|SUPERIORITY_OR_OTHER|||||||0.022||95.0||||P-value for pairwise comparison of Least Squares Means for Change from Baseline to Endpoint in Work/School.|t-test, 2 sided|||||||0.022
72604063|NCT00105989|144736373|SUPERIORITY_OR_OTHER|||||||0.11||95.0||||P-value for pairwise comparison of Least Squares Means for Change from Baseline to Endpoint in Social Life.|t-test, 2 sided|||||||0.110
72604064|NCT00105989|144736373|SUPERIORITY_OR_OTHER|||||||0.021||95.0||||P-value for pairwise comparison of Least Squares Means for Change from Baseline to Endpoint in Family Life/Home Responsibilities.|t-test, 2 sided|||||||0.021
72604065|NCT00105989|144736374|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values for Change from Baseline to Endpoint in all SF-36 subscales in the Acute Phase were \<0.001|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||<0.001
72604066|NCT00105989|144736374|SUPERIORITY_OR_OTHER|||||||0.947||95.0||||P-value for Physical Component Summary Change to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.947
72604067|NCT00105989|144736374|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Mental Component Summary Change to Endpoint|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||<0.001
72604068|NCT00105989|144736374|SUPERIORITY_OR_OTHER|||||||0.118||95.0||||P-value for Physical Functioning Change to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.118
72604069|NCT00105989|144736374|SUPERIORITY_OR_OTHER|||||||0.55||95.0||||P-value for Bodily Pain Change from Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.550
72604070|NCT00105989|144736374|SUPERIORITY_OR_OTHER|||||||0.029||95.0||||P-value for Role Limitations Due to Physical Change to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.029
72604071|NCT00105989|144736374|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Role Limitations Due to Emotional Problems Change to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||<0.001
72604072|NCT00105989|144736374|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||P-value for General Health Perceptions Change to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.002
72604073|NCT00105989|144736374|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Mental Health Change from Baseline to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||<0.001
72604074|NCT00105989|144736374|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Social Function Change from Baseline to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||<0.001
72604075|NCT00105989|144736374|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Vitality Change from Baseline to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||<0.001
72604076|NCT00105989|144736374|SUPERIORITY_OR_OTHER|||||||0.815||95.0||||P-value for Rate Current Health Change from Baseline to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.815
72604077|NCT00105989|144736374|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Health Compared to a Year Ago Change to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||<0.001
72604078|NCT00105989|144736375|SUPERIORITY_OR_OTHER|||||||0.415||95.0||||P-value is pairwise comparison of Least Squares Means for Change from Baseline-Physical Component Summary.|t-test, 2 sided|||||||0.415
72604079|NCT00105989|144736375|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||P-value is pairwise comparison of Least Squares Means for Change from Baseline-Mental Component Summary.|t-test, 2 sided|||||||0.002
72604080|NCT00105989|144736375|SUPERIORITY_OR_OTHER|||||||0.731||95.0||||P-value is pairwise comparison of Least Squares Means for Change from Baseline-Physical Functioning.|t-test, 2 sided|||||||0.731
72604081|NCT00105989|144736375|SUPERIORITY_OR_OTHER|||||||0.438||95.0||||P-value is pairwise comparison of Least Squares Means for Change from Baseline-Bodily Pain.|t-test, 2 sided|||||||0.438
72604082|NCT00105989|144736375|SUPERIORITY_OR_OTHER|||||||0.029||95.0||||P-value is pairwise comparison of Least Squares Means for Change from Baseline-Role Limitations Due to Physical.|t-test, 2 sided|||||||0.029
72604083|NCT00105989|144736375|SUPERIORITY_OR_OTHER|||||||0.003||95.0||||P-value is pairwise comparison of Least Squares Means for Change from Baseline-Role Limitations Due to Emotional problems.|t-test, 2 sided|||||||0.003
72604084|NCT00105989|144736375|SUPERIORITY_OR_OTHER|||||||0.391||95.0||||P-value is pairwise comparison of Least Squares Means for Change from Baseline-General Health Perceptions.|t-test, 2 sided|||||||0.391
72604085|NCT00105989|144736375|SUPERIORITY_OR_OTHER|||||||0.001||95.0||||P-value is pairwise comparison of Least Squares Means for Change from Baseline-Mental Health.|t-test, 2 sided|||||||0.001
72604086|NCT00105989|144736375|SUPERIORITY_OR_OTHER|||||||0.142||95.0||||P-value is pairwise comparison of Least Squares Means for Change from Baseline-Social Functioning.|t-test, 2 sided|||||||0.142
72604087|NCT00105989|144736375|SUPERIORITY_OR_OTHER|||||||0.24||95.0||||P-value is pairwise comparison of Least Squares Means for Change from Baseline-Vitality.|t-test, 2 sided|||||||0.240
72604088|NCT00105989|144736375|SUPERIORITY_OR_OTHER|||||||0.615||95.0||||P-value is pairwise comparison of Least Squares Means for Change from Baseline-Rate General Health.|t-test, 2 sided|||||||0.615
72604089|NCT00105989|144736375|SUPERIORITY_OR_OTHER|||||||0.218||95.0||||P-value is pairwise comparison of Least Squares Means for Change from Baseline-Health Compared to a Year Ago.|t-test, 2 sided|||||||0.218
72604090|NCT00105989|144736376|SUPERIORITY_OR_OTHER|||||||0.838||95.0||||P-value for change in number of Primary Health Care Provider Visits in Acute Phase|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.838
72604091|NCT00105989|144736376|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for change in number of Psychiatrist visits in Acute Phase|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||<0.001
72604092|NCT00105989|144736376|SUPERIORITY_OR_OTHER|||||||0.236||95.0||||P-value for change in number of Psychologist/Therapist visits in Acute Phase|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.236
72604093|NCT00105989|144736376|SUPERIORITY_OR_OTHER|||||||0.145||95.0||||P-value for change in number of Other Specialist Physician visits in Acute Phase|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.145
72604094|NCT00105989|144736376|SUPERIORITY_OR_OTHER|||||||0.423||95.0||||P-value for change in number of Other (Specified by Patient) visits in Acute Phase|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.423
72604095|NCT00105989|144736376|SUPERIORITY_OR_OTHER|||||||0.325||95.0||||P-value for change in number of Primary Health Care Provider visits in Continuation Phase|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.325
72604096|NCT00105989|144736376|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for change in number of Psychiatrist visits in Continuation Phase|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||<0.001
72604097|NCT00105989|144736376|SUPERIORITY_OR_OTHER|||||||0.915||95.0||||P-value for change in number of Psychologist/Therapist visits in Continuation Phase|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.915
72604098|NCT00105989|144736376|SUPERIORITY_OR_OTHER|||||||0.223||95.0||||P-value for change in number of Other Specialist Physician visits in Continuation Phase|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.223
72604099|NCT00105989|144736376|SUPERIORITY_OR_OTHER|||||||0.362||95.0||||P-value for change in number of Other (Specified by Patient) visits in Continuation Phase|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.362
72604100|NCT00105989|144736377|SUPERIORITY_OR_OTHER|||||||0.462||95.0||||P-value for pairwise comparison of means for change from baseline to endpoint in Primary Health Care Provider visits.|t-test, 2 sided|||||||0.462
72604101|NCT00105989|144736377|SUPERIORITY_OR_OTHER|||||||0.668||95.0||||P-value for pairwise comparison of means for change from baseline to endpoint in Psychiatrist visits.|t-test, 2 sided|||||||0.668
72604102|NCT00105989|144736377|SUPERIORITY_OR_OTHER|||||||0.746||95.0||||P-value for pairwise comparison of means for change from baseline to endpoint in Psychologist/Therapist visits.|t-test, 2 sided|||||||0.746
72604103|NCT00105989|144736377|SUPERIORITY_OR_OTHER|||||||0.511||95.0||||P-value for pairwise comparison of means for change from baseline to endpoint in Other Specialist Physician visits.|t-test, 2 sided|||||||0.511
72604104|NCT00105989|144736377|SUPERIORITY_OR_OTHER|||||||0.271||95.0||||P-value for pairwise comparison of means for change from baseline to endpoint in Other (Specified by Patient) Provider visits.|t-test, 2 sided|||||||0.271
72604105|NCT00105989|144736378|SUPERIORITY_OR_OTHER|||||||0.506||95.0||||P-value for Change in Average Number of Hours Worked In a Week in Acute Phase|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.506
72604106|NCT00105989|144736378|SUPERIORITY_OR_OTHER|||||||0.057||95.0||||P-value for Change in Average Number of Hours Worked In a Week in Continuation Phase|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.057
72604107|NCT00105989|144736379|SUPERIORITY_OR_OTHER|||||||0.826||95.0|||||t-test, 2 sided|||||||0.826
72604108|NCT00105989|144736380|SUPERIORITY_OR_OTHER|||||||0.105||95.0||||P-value for Change in Number of Missed Paid Work Hours in Acute Phase|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.105
72604109|NCT00105989|144736380|SUPERIORITY_OR_OTHER|||||||0.174||95.0||||P-value for Change in Number of Missed Paid Work Hours in Continuation Phase|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.174
72604110|NCT00105989|144736381|SUPERIORITY_OR_OTHER|||||||0.037||95.0|||||t-test, 2 sided|||||||0.037
72604111|NCT00105989|144736382|SUPERIORITY_OR_OTHER|||||||0.785||95.0||||P-value for Sum Items 1 to 5 Change to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.785
72604112|NCT00105989|144736382|SUPERIORITY_OR_OTHER|||||||0.354||95.0||||P-value for Sum Items 1\&2 Change to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.354
72604113|NCT00105989|144736382|SUPERIORITY_OR_OTHER|||||||0.17||95.0||||P-value for Item 1-Sex Drive Change to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.170
72604114|NCT00105989|144736382|SUPERIORITY_OR_OTHER|||||||0.825||95.0||||P-value for Item 2-Arousal Change to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.825
72604115|NCT00105989|144736382|SUPERIORITY_OR_OTHER|||||||0.877||95.0||||P-value for Item 3-Vaginal Lubrication/Penile Erection Change to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.877
72604116|NCT00105989|144736382|SUPERIORITY_OR_OTHER|||||||0.009||95.0||||P-value for Item 4-Orgasm Change to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.009
72604117|NCT00105989|144736382|SUPERIORITY_OR_OTHER|||||||0.67||95.0||||P-value for Item 5-Satisfaction Change to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.670
72604118|NCT00105989|144736382|SUPERIORITY_OR_OTHER|||||||0.1||95.0||||P-value for Sum Items 1 to 5 Change to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.100
72604119|NCT00105989|144736382|SUPERIORITY_OR_OTHER|||||||0.021||95.0||||P-value for Sum Items 1\&2 Change to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.021
72604120|NCT00105989|144736382|SUPERIORITY_OR_OTHER|||||||0.047||95.0||||P-value for Item 1-Sex Drive Change to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.047
72604121|NCT00105989|144736382|SUPERIORITY_OR_OTHER|||||||0.023||95.0||||P-value for Item 2-Arousal Change to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.023
72604122|NCT00105989|144736382|SUPERIORITY_OR_OTHER|||||||0.668||95.0||||P-value for Item 3-Vaginal Lubrication/Penile Erection Change to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.668
72604123|NCT00105989|144736382|SUPERIORITY_OR_OTHER|||||||0.136||95.0||||P-value for Item 4-Orgasm Change to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.136
72604124|NCT00105989|144736382|SUPERIORITY_OR_OTHER|||||||0.152||95.0||||P-value for Item 5-Satisfaction Change to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.152
72604125|NCT00105989|144736383|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Sum Items 1 to 5 Change to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||<0.001
72604126|NCT00105989|144736383|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Sum Items 1\&2 Change to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||<0.001
72604127|NCT00105989|144736383|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Item 1-Sex Drive Change to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||<0.001
72604128|NCT00105989|144736383|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Item 2-Arousal Change to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||<0.001
72604129|NCT00105989|144736383|SUPERIORITY_OR_OTHER|||||||0.005||95.0||||P-value for Item 3-Vaginal Lubrication/Penile Erection Change to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.005
72604130|NCT00105989|144736383|SUPERIORITY_OR_OTHER|||||||0.05||95.0||||P-value for Item 4-Orgasm Change to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.050
72604131|NCT00105989|144736383|SUPERIORITY_OR_OTHER|||||||0.022||95.0||||P-value for Item 5-Satisfaction Change to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.022
72604132|NCT00105989|144736383|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||P-value for Sum Items 1 to 5 Change to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.002
72604133|NCT00105989|144736383|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Sum Items 1\&2 Change to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||<0.001
72604134|NCT00105989|144736383|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Item 1-Sex Drive Change to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||<0.001
72604135|NCT00105989|144736383|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Item 2-Arousal Change to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||<0.001
72604136|NCT00105989|144736383|SUPERIORITY_OR_OTHER|||||||0.186||95.0||||P-value for Item 3-Vaginal Lubrication/Penile Erection Change to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.186
72604137|NCT00105989|144736383|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Item 4-Orgasm Change to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||<0.001
72604138|NCT00105989|144736383|SUPERIORITY_OR_OTHER|||||||0.308||95.0||||P-value for Item 5-Satisfaction Change to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.308
72604139|NCT00105989|144736384|SUPERIORITY_OR_OTHER|||||||0.773||95.0||||P-value for pairwise comparison Least Squares Mean change from baseline for the Sum of Items 1 to 5.|t-test, 2 sided|||||||0.773
72604140|NCT00105989|144736384|SUPERIORITY_OR_OTHER|||||||0.405||95.0||||P-value for pairwise comparison Least Squares Mean change from baseline for the Sum of Items 1 and 2.|t-test, 2 sided|||||||0.405
72604141|NCT00105989|144736384|SUPERIORITY_OR_OTHER|||||||0.443||95.0||||P-value for pairwise comparison Least Squares Mean change from baseline for Item 1-Sex Drive.|t-test, 2 sided|||||||0.443
72604142|NCT00105989|144736384|SUPERIORITY_OR_OTHER|||||||0.384||95.0||||P-value for pairwise comparison Least Squares Mean change from baseline for Item 2-Arousal.|t-test, 2 sided|||||||0.384
72604143|NCT00105989|144736384|SUPERIORITY_OR_OTHER|||||||0.268||95.0||||P-value for pairwise comparison Least Squares Mean change from baseline for Item 3-Vaginal Lubrication/Penile Erection.|t-test, 2 sided|||||||0.268
72604144|NCT00105989|144736384|SUPERIORITY_OR_OTHER|||||||0.093||95.0||||P-value for pairwise comparison Least Squares Mean change from baseline for Item 4-Orgasm.|t-test, 2 sided|||||||0.093
72604145|NCT00105989|144736384|SUPERIORITY_OR_OTHER|||||||0.566||95.0||||P-value for pairwise comparison Least Squares Mean change from baseline for Item 5-Satisfaction.|t-test, 2 sided|||||||0.566
72604146|NCT00105989|144736385|SUPERIORITY_OR_OTHER|||||||0.979||95.0||||P-value for pairwise comparison Least Squares Mean change from baseline for the Sum of Items 1 to 5.|t-test, 2 sided|||||||0.979
72604147|NCT00105989|144736385|SUPERIORITY_OR_OTHER|||||||0.132||95.0||||P-value for pairwise comparison Least Squares Mean change from baseline for the Sum of Items 1 and 2.|t-test, 2 sided|||||||0.132
72604148|NCT00105989|144736385|SUPERIORITY_OR_OTHER|||||||0.18||95.0||||P-value for pairwise comparison Least Squares Mean change from baseline for Item 1-Sex Drive.|t-test, 2 sided|||||||0.180
72604149|NCT00105989|144736385|SUPERIORITY_OR_OTHER|||||||0.163||95.0||||P-value for pairwise comparison Least Squares Mean change from baseline for Item 2-Arousal.|t-test, 2 sided|||||||0.163
72604150|NCT00105989|144736385|SUPERIORITY_OR_OTHER|||||||0.844||95.0||||P-value for pairwise comparison Least Squares Mean change from baseline for Item 3-Vaginal Lubrication/Penile Erection.|t-test, 2 sided|||||||0.844
72604151|NCT00105989|144736385|SUPERIORITY_OR_OTHER|||||||0.609||95.0||||P-value for pairwise comparison Least Squares Mean change from baseline for Item 4-Orgasm.|t-test, 2 sided|||||||0.609
72604152|NCT00105989|144736385|SUPERIORITY_OR_OTHER|||||||0.071||95.0||||P-value for pairwise comparison Least Squares Mean change from baseline for Item 5-Satisfaction.|t-test, 2 sided|||||||0.071
72604153|NCT00105989|144736386|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Weight Change from Baseline to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||<0.001
72604154|NCT00105989|144736386|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Weight Change from Baseline to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||<0.001
72604155|NCT00105989|144736387|SUPERIORITY_OR_OTHER|||||||0.314||95.0|||||t-test, 2 sided|||||||0.314
72604156|NCT00105989|144736388|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Pulse Change from Baseline to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||<0.001
72604157|NCT00105989|144736388|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Pulse Change from Baseline to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||<0.001
72604158|NCT00105989|144736389|SUPERIORITY_OR_OTHER|||||||0.891||95.0|||||t-test, 2 sided|||||||0.891
72604159|NCT00105989|144736390|SUPERIORITY_OR_OTHER|||||||0.659||95.0||||P-value for systolic blood pressure change to endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.659
72604160|NCT00105989|144736390|SUPERIORITY_OR_OTHER|||||||0.064||95.0||||P-value for diastolic blood pressure change to endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.064
72604161|NCT00105989|144736390|SUPERIORITY_OR_OTHER|||||||0.224||95.0||||P-value for systolic blood pressure change to endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.224
72604162|NCT00105989|144736390|SUPERIORITY_OR_OTHER|||||||0.21||95.0||||P-value for diastolic blood pressure change to endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.210
72604163|NCT00105989|144736391|SUPERIORITY_OR_OTHER|||||||0.134||95.0||||P-value for Change from Baseline: systolic blood pressure.|t-test, 2 sided|||||||0.134
72604164|NCT00105989|144736391|SUPERIORITY_OR_OTHER|||||||0.816||95.0||||P-value for Change from Baseline: diastolic blood pressure.|t-test, 2 sided|||||||0.816
72604165|NCT00105989|144736392|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||<.001
72604166|NCT00105989|144736393|SUPERIORITY_OR_OTHER|||||||0.007||95.0|||||t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||.007
72604167|NCT00105989|144736394|SUPERIORITY_OR_OTHER|||||||0.035||95.0|||||t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||.035
72604168|NCT00105989|144736395|SUPERIORITY_OR_OTHER|||||||0.021||95.0|||||t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||.021
72604169|NCT00105989|144736396|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||<.001
72604170|NCT00105989|144736397|SUPERIORITY_OR_OTHER|||||||0.019||95.0||||The mean change to endpoint of -0.00 indicates that on average, endpoint score decreased from baseline score by less than 0.005 units.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||.019
72604171|NCT00105989|144736398|SUPERIORITY_OR_OTHER|||||||0.005||95.0|||||t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||.005
72604172|NCT00105989|144736399|SUPERIORITY_OR_OTHER|||||||0.031||95.0|||||t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||.031
72604173|NCT00105989|144736400|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||<.001
72604174|NCT00105989|144736401|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||<.001
72604175|NCT00105989|144736402|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||<.001
72604176|NCT00105989|144736403|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||<.001
72604177|NCT00105989|144736404|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||<.001
72604178|NCT00105989|144736405|SUPERIORITY_OR_OTHER|||||||0.004||95.0|||||t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||.004
72604179|NCT00105989|144736406|SUPERIORITY_OR_OTHER|||||||0.01||95.0|||||t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||.010
72604180|NCT00105989|144736407|SUPERIORITY_OR_OTHER|||||||0.003||95.0|||||t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||.003
72604181|NCT00105989|144736408|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||<.001
72604182|NCT00105989|144736409|SUPERIORITY_OR_OTHER|||||||0.015||95.0|||||t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||.015
72604183|NCT00105989|144736410|SUPERIORITY_OR_OTHER|||||||0.021||95.0||||The mean change to endpoint of -0.00 indicates that on average, endpoint score decreased from baseline score by less than 0.005 units.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||.021
72604184|NCT00105989|144736411|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||<.001
72604185|NCT00105989|144736412|SUPERIORITY_OR_OTHER|||||||0.032||95.0|||||t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||.032
72604186|NCT00105989|144736413|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||<.001
72604187|NCT00105989|144736414|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||<.001
72604188|NCT00105989|144736415|SUPERIORITY_OR_OTHER|||||||0.028||95.0|||||t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||.028
72604189|NCT00105989|144736416|SUPERIORITY_OR_OTHER|||||||0.008||95.0|||||t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||.008
72604190|NCT00105989|144736417|SUPERIORITY_OR_OTHER|||||||0.046||95.0|||||t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||.046
72604191|NCT00105989|144736418|SUPERIORITY_OR_OTHER|||||||0.035||95.0||||P-value for Change to Endpoint.|ANOVA|Type II Sums of Squares from an analysis of variance (ANOVA) on the Ranks: Model = Pooled Investigator and Therapy.||||||0.035
72604192|NCT00105989|144736419|SUPERIORITY_OR_OTHER|||||||0.011||95.0||||P-value for Change to Endpoint.|ANOVA|Type II Sums of Squares from an analysis of variance (ANOVA) on the Ranks: Model = Pooled Investigator and Therapy.||||||0.011
72604193|NCT00105989|144736420|SUPERIORITY_OR_OTHER|||||||0.744||95.0||||P-value for fasting glucose change from baseline to endpoint|ANOVA|Type II Sums of Squares from an analysis of variance (ANOVA) on the Ranks: Model = Pooled Investigator and Therapy.||||||0.744
72604194|NCT00105989|144736420|SUPERIORITY_OR_OTHER|||||||0.03||95.0||||P-value for non-fasting glucose change from baseline to endpoint.|ANOVA|Type II Sums of Squares from an analysis of variance (ANOVA) on the Ranks: Model = Pooled Investigator and Therapy.||||||0.030
72604195|NCT00357877|144736423|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.25|STANDARD_ERROR_OF_MEAN|0.44||0.56|TWO_SIDED|95.0|-0.6|1.11||No interim analyses were done and no adjustment made for multiple comparisons. Identical analyses were run on each imputed dataset, with results combined with SAS® PROC MIANALZE to obtain final p-values.|Regression, Linear|The primary outcome analysis included treatment and site as class variables and age and age-squared as continuous covariates.||We hypothesized a lower increment score for the active treatment group but carried out two-tailed hypothesis testing. Sample size was estimated with simulated data with rank normalized scores. We calculated that 832 participants would yield a power of 90% to detect a 20% reduction in caries incidence (from a hypothesized mean increment of 1.5), and adopted a target of 1000 randomized participants to allow for attrition.||1.11|-0.60|0.56
72604196|NCT00357877|144736424|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.35|STANDARD_ERROR_OF_MEAN|0.57||0.54|TWO_SIDED|95.0|-0.77|1.46||No adjustment for multiple comparisons. Identical analyses were run on each imputed dataset, with results combined with SAS® PROC MIANALYZE to obtain final p-values.|Regression, Linear|Model included treatment and site as class variables and age and age-squared as continuous covariates.||hypothesized a reduced caries increment in active arm, though conducted two-tailed hypothesis test.||1.46|-0.77|0.54
72604197|NCT00357877|144736425|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.51|STANDARD_ERROR_OF_MEAN|0.38||0.18|TWO_SIDED|95.0|-1.25|0.23||No adjustment for multiple comparisons. Identical analyses were run on each imputed dataset, with results combined with SAS® PROC MIANALYZE to obtain final p-values.|Regression, Linear|treatment and site included as class variables and age and age-squared as continuous covariates.||Hypothesized lower increment in active arm, though hypothesis testing was two-sided.||0.23|-1.25|0.18
72604198|NCT00357877|144736426|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.68|STANDARD_DEVIATION|0.57||0.24|TWO_SIDED|95.0|-1.8|0.45||No adjustment for multiple comparisons. Identical analyses were run on each imputed dataset, with results combined with SAS® PROC MIANALYZE to obtain final p-values.|Regression, Linear|Model included treatment and site as class variables, and age and age-squared as continuous covariates.||Hypothesized a lower increment for active treatment arm, although hypothesis testing was two-sided.||0.45|-1.80|0.24
72604199|NCT03570047|144736450|OTHER||Hazard Ratio (HR)|0.65|||<|0.0001|TWO_SIDED|95.0|0.558|0.766|||Cox proportional hazards model|||||0.766|0.558|<0.0001
72604200|NCT03570047|144736450|OTHER||Hazard Ratio (HR)|0.79||||0.0291|TWO_SIDED|95.0|0.642|0.977|||Cox proportional hazards model|||||0.977|0.642|0.0291
72604201|NCT03570047|144736450|OTHER||Hazard Ratio (HR)|0.71||||0.0001|TWO_SIDED|95.0|0.592|0.842|||Cox proportional hazards model|||||0.842|0.592|0.0001
72604202|NCT03570047|144736450|OTHER||Hazard Ratio (HR)|0.72||||0.0012|TWO_SIDED|95.0|0.591|0.879|||Cox proportional hazards model|||||0.879|0.591|0.0012
72604203|NCT03570047|144736451|OTHER||Hazard Ratio (HR)|0.72|||<|0.0001|TWO_SIDED|95.0|0.614|0.843|||Cox proportional hazards model|||||0.843|0.614|<0.0001
72604204|NCT03570047|144736451|OTHER||Hazard Ratio (HR)|0.66||||0.0003|TWO_SIDED|95.0|0.529|0.825|||Cox proportional hazards model|||||0.825|0.529|0.0003
72604205|NCT03570047|144736451|OTHER||Hazard Ratio (HR)|0.74||||0.0007|TWO_SIDED|95.0|0.618|0.879|||Cox proportional hazards model|||||0.879|0.618|0.0007
72604206|NCT03570047|144736451|OTHER||Hazard Ratio (HR)|0.71||||0.0011|TWO_SIDED|95.0|0.583|0.874|||Cox proportional hazards model|||||0.874|0.583|0.0011
72604207|NCT03570047|144736452|OTHER||Hazard Ratio (HR)|0.93||||0.0127|TWO_SIDED|95.0|0.872|0.984|||Cox proportional hazards model|||||0.984|0.872|0.0127
72604208|NCT03570047|144736452|OTHER||Hazard Ratio (HR)|0.96||||0.2893||95.0|0.881|1.039|||Cox proportional hazards model|||||1.039|0.881|0.2893
72604209|NCT03570047|144736452|OTHER||Hazard Ratio (HR)|0.94||||0.064|TWO_SIDED|95.0|0.881|1.004|||Cox proportional hazards model|||||1.004|0.881|0.0640
72604210|NCT03570047|144736452|OTHER||Hazard Ratio (HR)|1.03||||0.4404|TWO_SIDED|95.0|0.958|1.103|||Cox proportional hazards model|||||1.103|0.958|0.4404
72604211|NCT02820870|144736489|SUPERIORITY||Odds Ratio (OR)|3.0|||<|0.01|TWO_SIDED|95.0|1.84|4.9|||Regression, Logistic|With clustering by provider and team.||||4.9|1.84|<0.01
72604212|NCT02820870|144736490|SUPERIORITY||Odds Ratio (OR)|1.65||||0.06|TWO_SIDED|95.0|0.99|2.77|||Regression, Logistic|With cluster by provider and team.||||2.77|0.99|0.06
72604213|NCT02754518|144736493|OTHER||||||<|0.001||||||P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05, and conducted using STATA MP version 15 (College Station, TX).|t-test, 2 sided|Paired t-test||Primary outcome was presented at baseline and 1-year as means +/- standard deviations based upon the Shapiro-Wilks test of normality, and then analyzed with paired t-tests.||||<0.001
72604214|NCT02754518|144736494|OTHER||||||<|0.001||||||P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05, and conducted using STATA MP version 15 (College Station, TX).|t-test, 2 sided|paired t-test||Primary outcome was presented at baseline and 1-year as means +/- standard deviations based upon the Shapiro-Wilks test of normality, and then analyzed with paired t-tests.||||<0.001
72604215|NCT02754518|144736495|OTHER||||||<|0.001||||||P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05, and conducted using STATA MP version 15 (College Station, TX).|t-test, 2 sided|paired t-test||Primary outcome was presented at baseline and 1-year as means +/- standard deviations based upon the Shapiro-Wilks test of normality, and then analyzed with paired t-tests.||||<0.001
72604216|NCT02754518|144736496|OTHER||||||<|0.001||||||P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05, and conducted using STATA MP version 15 (College Station, TX).|Sign test|||Primary outcome was presented at baseline and 1-year as medians (interquartile range) based upon the Shapiro-Wilks test of normality, and then analyzed with Wilcoxon signed-rank test.||||<0.001
72604217|NCT02754518|144736497|OTHER||||||<|0.001||||||P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05, and conducted using STATA MP version 15 (College Station, TX).|Sign test|||Primary outcome was presented at baseline and 1-year as medians (interquartile range) based upon the Shapiro-Wilks test of normality, and then analyzed with Wilcoxon signed-rank test.||||<0.001
72604218|NCT02754518|144736498|OTHER||||||<|0.001||||||P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05, and conducted using STATA MP version 15 (College Station, TX).|Sign test|||Primary outcome was presented at baseline and 1-year as medians (interquartile range) based upon the Shapiro-Wilks test of normality, and then analyzed with Wilcoxon signed-rank test.||||<0.001
72604219|NCT02754518|144736499|OTHER||||||<|0.001||||||P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05, and conducted using STATA MP version 15 (College Station, TX).|t-test, 2 sided|Paired t-test||Primary outcome was presented at baseline and 1-year as means +/- standard deviations based upon the Shapiro-Wilks test of normality, and then analyzed with paired t-tests.||||<0.001
72604220|NCT02754518|144736500|OTHER|||||||0.13||||||P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05, and conducted using STATA MP version 15 (College Station, TX).|t-test, 2 sided|||Primary outcome was presented at baseline and 1-year as means +/- standard deviations based upon the Shapiro-Wilks test of normality, and then analyzed with paired t-tests.|paired t-test|||0.13
72604221|NCT02754518|144736501|OTHER|||||||0.95||||||P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05, and conducted using STATA MP version 15 (College Station, TX).|t-test, 2 sided|Paired t-test||Primary outcome was presented at baseline and 1-year as means +/- standard deviations based upon the Shapiro-Wilks test of normality, and then analyzed with paired t-tests.||||0.95
72604222|NCT02754518|144736502|OTHER||||||<|0.001||||||P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05, and conducted using STATA MP version 15 (College Station, TX).|Sign test|||Primary outcome was presented at baseline and 1-year as medians (interquartile range) based upon the Shapiro-Wilks test of normality, and then analyzed with Wilcoxon signed-rank test.||||<0.001
72604223|NCT02754518|144736503|OTHER||||||<|0.001||||||P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05, and conducted using STATA MP version 15 (College Station, TX).|Sign test|||Primary outcome was presented at baseline and 1-year as medians (interquartile range) based upon the Shapiro-Wilks test of normality, and then analyzed with Wilcoxon signed-rank test.||||<0.001
72604224|NCT02754518|144736504|OTHER|||||||0.65||||||P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05, and conducted using STATA MP version 15 (College Station, TX).|t-test, 2 sided|Paired T-test||Primary outcome was presented at baseline and 1-year as means +/- standard deviations based upon the Shapiro-Wilks test of normality, and then analyzed with paired t-tests.||||0.65
72604225|NCT02754518|144736505|OTHER|||||||0.06||||||P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05, and conducted using STATA MP version 15 (College Station, TX).|Sign test|||Primary outcome was presented at baseline and 1-year as means +/- standard deviations based upon the Shapiro-Wilks test of normality, and then analyzed with paired t-tests.||||0.06
72604226|NCT02754518|144736506|OTHER|||||||0.76||||||P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05, and conducted using STATA MP version 15 (College Station, TX).|Sign test|||Primary outcome was presented at baseline and 1-year as medians (interquartile range) based upon the Shapiro-Wilks test of normality, and then analyzed with Wilcoxon signed-rank test.||||0.76
72604227|NCT02754518|144736507|OTHER|||||||0.07||||||P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05, and conducted using STATA MP version 15 (College Station, TX).|Fisher Exact|||Primary outcome was presented at baseline and 1-year as frequency and percentages based upon the Shapiro-Wilks test of normality, and then analyzed with the Fisher exact test.||||0.07
72604228|NCT02754518|144736508|OTHER|||||||0.001||||||P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05, and conducted using STATA MP version 15 (College Station, TX).|Sign test|||Primary outcome was presented at baseline and 1-year as medians (interquartile range) based upon the Shapiro-Wilks test of normality, and then analyzed with Wilcoxon signed-rank test.||||0.001
72604229|NCT02754518|144736511|OTHER|||||||0.03||||||P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05, and conducted using STATA MP version 15 (College Station, TX).|Sign test|||Primary outcome was presented at baseline and 1-year as medians (interquartile range) based upon the Shapiro-Wilks test of normality, and then analyzed with Wilcoxon signed-rank test.||||0.03
72604230|NCT02754518|144736512|OTHER||||||<|0.001||||||P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05, and conducted using STATA MP version 15 (College Station, TX).|t-test, 2 sided|Paired t-test||Primary outcome was presented at baseline and 1-year as means +/- standard deviations based upon the Shapiro-Wilks test of normality, and then analyzed with paired t-tests.||||<0.001
72604231|NCT02754518|144736513|OTHER|||||||0.02||||||P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05, and conducted using STATA MP version 15 (College Station, TX).|Sign test|||Primary outcome was presented at baseline and 1-year as medians (interquartile range) based upon the Shapiro-Wilks test of normality, and then analyzed with Wilcoxon signed-rank test.||||0.02
72604232|NCT02754518|144736514|OTHER||||||<|0.001||||||P-Values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05, and conducted using STATA MP version 15 (College Station, TX).|t-test, 2 sided|Paired t-test||Primary outcome was presented at baseline and 1-year as means +/- standard deviations based upon the Shapiro-Wilks test of normality, and then analyzed with paired t-tests.||||<0.001
72604233|NCT02754518|144736515|OTHER|||||||0.82||||||P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05, and conducted using STATA MP version 15 (College Station, TX).|Sign test|||Primary outcome was presented at baseline and 1-year as medians (interquartile range) based upon the Shapiro-Wilks test of normality, and then analyzed with Wilcoxon signed-rank test.||||0.82
72604234|NCT02754518|144736516|OTHER||||||<|0.001||||||P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05, and conducted using STATA MP version 15 (College Station, TX).|Sign test|||Primary outcome was presented at baseline and 1-year as medians (interquartile range) based upon the Shapiro-Wilks test of normality, and then analyzed with Wilcoxon signed-rank test.||||<0.001
72604235|NCT02754518|144736517|OTHER|||||||0.01||||||P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05, and conducted using STATA MP version 15 (College Station, TX).|Sign test|||Primary outcome was presented at baseline and 1-year as medians (interquartile range) based upon the Shapiro-Wilks test of normality, and then analyzed with Wilcoxon signed-rank test.||||0.01
72604236|NCT02754518|144736518|OTHER|||||||0.11||||||P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05, and conducted using STATA MP version 15 (College Station, TX).|Sign test|||Primary outcome was presented at baseline and 1-year as medians (interquartile range) based upon the Shapiro-Wilks test of normality, and then analyzed with Wilcoxon signed-rank test.||||0.11
72604237|NCT02754518|144736519|OTHER|||||||0.17||||||P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05, and conducted using STATA MP version 15 (College Station, TX).|Sign test|||Primary outcome was presented at baseline and 1-year as medians (interquartile range) based upon the Shapiro-Wilks test of normality, and then analyzed with Wilcoxon signed-rank test.||||0.17
72604238|NCT02754518|144736520|OTHER|||||||0.035||||||P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05, and conducted using STATA MP version 15 (College Station, TX).|Sign test|||Primary outcome was presented at baseline and 1-year as medians (interquartile range) based upon the Shapiro-Wilks test of normality, and then analyzed with Wilcoxon signed-rank test.||||0.035
72604239|NCT02754518|144736521|OTHER|||||||0.059||||||P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05, and conducted using STATA MP version 15 (College Station, TX).|Sign test|||Primary outcome was presented at baseline and 1-year as medians (interquartile range) based upon the Shapiro-Wilks test of normality, and then analyzed with Wilcoxon signed-rank test.||||0.059
72604240|NCT02754518|144736522|OTHER|||||||0.054||||||P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05, and conducted using STATA MP version 15 (College Station, TX).|Sign test|||Primary outcome was presented at baseline and 1-year as medians (interquartile range) based upon the Shapiro-Wilks test of normality, and then analyzed with Wilcoxon signed-rank test.||||0.054
72604241|NCT02754518|144736523|OTHER|||||||0.28||||||P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05, and conducted using STATA MP version 15 (College Station, TX).|Sign test|||Primary outcome was presented at baseline and 1-year as medians (interquartile range) based upon the Shapiro-Wilks test of normality, and then analyzed with Wilcoxon signed-rank test.||||0.28
72604242|NCT02754518|144736524|OTHER|||||||0.002||||||P-Values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05, and conducted using STATA MP version 15 (College Station, TX).|Sign test|||Primary outcome was presented at baseline and 1-year as medians (interquartile range) based upon the Shapiro-Wilks test of normality, and then analyzed with Wilcoxon signed-rank test.||||0.002
72604243|NCT02754518|144736525|OTHER|||||||0.008||||||P-Values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05, and conducted using STATA MP version 15 (College Station, TX).|Sign test|||Primary outcome was presented at baseline and 1-year as medians (interquartile range) based upon the Shapiro-Wilks test of normality, and then analyzed with Wilcoxon signed-rank test.||||0.008
72604244|NCT02754518|144736526|OTHER|||||||0.005||||||P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05, and conducted using STATA MP version 15 (College Station, TX).|Sign test|||Primary outcome was presented at baseline and 1-year as medians (interquartile range) based upon the Shapiro-Wilks test of normality, and then analyzed with Wilcoxon signed-rank test.||||0.005
72604245|NCT02754518|144736527|OTHER|||||||0.056||||||P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05, and conducted using STATA MP version 15 (College Station, TX).|Sign test|||Primary outcome was presented at baseline and 1-year as medians (interquartile range) based upon the Shapiro-Wilks test of normality, and then analyzed with Wilcoxon signed-rank test.||||0.056
72604246|NCT03318003|144736529|SUPERIORITY||Pearson Chi Square|0.76||||0.92|TWO_SIDED|||||no adjustments made|Chi-squared|||||||0.92
72604247|NCT02080364|144736578|SUPERIORITY|||||||0.3386||||||p-value for comparison to Placebo|Mixed Models Analysis|||||||0.3386
72604248|NCT02080364|144736578|SUPERIORITY|||||||0.1992||||||p-value for compairons to Placebo|Mixed Models Analysis|||||||0.1992
72604249|NCT02080364|144736579|SUPERIORITY|||||||0.9394||||||p-value for comparison to Placebo.|Mixed Models Analysis|||||||0.9394
72604250|NCT02080364|144736579|SUPERIORITY||||||||||||||||||MMRM model does not converge. LS Mean and p-value are NA.|||
72604251|NCT02497404|144736588|OTHER|Clopper-Pearson (exact) 95% confidence interval provided for the survival proportion.|Proportion (percent)|46.2|||||TWO_SIDED|95.0|30.1|62.8||||||||62.8|30.1|
72604252|NCT02497404|144736589|OTHER|Clopper-Pearson (exact) 95% confidence interval provided for the survival proportion.|Proportion (percent)|64.1|||||TWO_SIDED|95.0|47.2|78.8||||||||78.8|47.2|
72604253|NCT02497404|144736590|OTHER|Clopper-Pearson (exact) 95% confidence interval provided for the survival proportion.|Proportion (percent)|33.3|||||TWO_SIDED|95.0|19.1|50.2||||||||50.2|19.1|
72604254|NCT02497404|144736591|OTHER|Clopper-Pearson (exact) 95% confidence interval provided for the survival proportion.|Proportion (percent)|89.7|||||TWO_SIDED|95.0|75.8|97.1||||||||97.1|75.8|
72604255|NCT02497404|144736592|OTHER|Clopper-Pearson (exact) 95% confidence interval provided for the survival proportion.|Proportion (percent)|64.1|||||TWO_SIDED|95.0|47.2|78.8||||||||78.8|47.2|
72604256|NCT02497404|144736593|OTHER||Proportion (percent)|38.5|||||TWO_SIDED|95.0|23.4|55.4||||||Clopper-Pearson (exact) 95% confidence interval provided for the survival proportion.||55.4|23.4|
72604257|NCT02497404|144736594|OTHER|Clopper-Pearson (exact) 95% confidence interval provided for the graft failure proportion.|Proportion (percent)|2.6|||||TWO_SIDED|95.0|0.07|13.5||||||||13.5|0.07|
72604258|NCT02497404|144736595|OTHER|Clopper-Pearson (exact) 95% confidence interval provided for the GVHD proportion.|Proportion (percent)|33.3|||||TWO_SIDED|95.0|19.1|50.2||||||||50.2|19.1|
72604259|NCT02497404|144736596|OTHER|Clopper-Pearson (exact) 95% confidence interval provided for the high-risk extensive chronic graft-versus-host-disease proportion.|Proportion (percent)|5.1|||||TWO_SIDED|95.0|0.63|15.3||||||||15.3|0.63|
72604260|NCT02797678|144736622|SUPERIORITY|||||||0.061|||||||paired t-test|||||||0.061
72604261|NCT02797678|144736625|SUPERIORITY|||||||0.301|||||||paired t-test|||||||0.301
72604262|NCT02497937|144736641|OTHER||Mean Difference (Net)|0.793|||||TWO_SIDED|95.0|-0.925|2.512|||||Difference estimate of DLco on Day 7 has been presented for Mayo site|||2.512|-0.925|
72604263|NCT03790865|144736679|SUPERIORITY||Mean Difference (Net)|4.0|||<|0.025|TWO_SIDED||||||Mixed Models Analysis|||||||<0.025
72604264|NCT00511173|144736728|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.0|STANDARD_DEVIATION|4.5|<|0.05|TWO_SIDED|95.0|||||t-test, 2 sided|||Null hypothesis: there is no difference in warfarin dose (mg/wk) between pharmacist dosing and algorithm dosing. In order to gather all SNP groups, the power analysis resulted in \> 100 patients enrolled into each group.||||< 0.05
72604265|NCT03569098|144736732|SUPERIORITY||Difference in LS mean|0.32|STANDARD_ERROR_OF_MEAN|0.441||0.7669|TWO_SIDED|95.0|-0.55|1.19||One-sided P-value. The model includes the fixed categorical effects of treatment group, visit, treatment group-by-visit interaction, and the stratification factor as fixed categorical covariates and the Baseline value as a fixed continuous covariate.|Mixed Model for Repeated Measures (MMRM)|||Dysport 300 U versus Placebo.||1.19|-0.55|0.7669
72604266|NCT03569098|144736732|SUPERIORITY||Difference in LS mean|-0.36|STANDARD_ERROR_OF_MEAN|0.444||0.2085|TWO_SIDED|95.0|-1.24|0.51||One-sided P-value. The model includes the fixed categorical effects of treatment group, visit, treatment group-by-visit interaction, and the stratification factor as fixed categorical covariates and the Baseline value as a fixed continuous covariate.|MMRM|||Dysport 500 U versus Placebo.||0.51|-1.24|0.2085
72604267|NCT00758498|144736746|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.9|||<|0.0001|TWO_SIDED|95.0|2.07|3.71|||ANCOVA|Treatment was a factor and baseline value was a co-variate||||3.71|2.07|<0.0001
72604268|NCT00758498|144736746|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.9|||<|0.0001|TWO_SIDED|95.0|6.06|7.69|||ANCOVA|Treatment was a factor and baseline value was a co-variate||||7.69|6.06|<0.0001
72604269|NCT00758498|144736747|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.8341|TWO_SIDED|95.0|-0.2|0.25|||ANOVA|||||0.25|-0.20|0.8341
72604270|NCT00758498|144736747|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3||||0.0441|TWO_SIDED|95.0|-0.5|-0.05|||ANCOVA|||||-0.05|-0.50|0.0441
72604271|NCT00758498|144736748|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|||||||<0.0001
72604272|NCT00758498|144736748|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|||||||<0.0001
72604273|NCT00758498|144736749|SUPERIORITY_OR_OTHER|||||||0.0012|||||||ANCOVA|Treatment comparisons made use of an analysis of covariance (ANCOVA) analysis with treatment as a factor and baseline value as a covariate||||||0.0012
72604274|NCT00758498|144736749|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|Analysis by ANCOVA with treatment as a factor and the baseline value as a covariate||||||<0.0001
72416252|NCT01972841|144343306|SUPERIORITY||Least squares mean difference|-2.61|STANDARD_ERROR_OF_MEAN|0.76|<|0.001|TWO_SIDED|95.0|-4.09|-1.12|||Stratified rank ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (mirabegron 25 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||-1.12|-4.09|<0.001
72604275|NCT00758498|144736750|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Analysis of treatment comparisons is based on an analysis of variance (ANCOVA) with treatment as a factor and the baseline value as covariate|ANCOVA|||||||<0.0001
72604276|NCT00758498|144736750|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|Analysis of treatment comparisons is based on an ANCOVA with treatment as a factor and baseline value as a covariate||||||<0.0001
72604277|NCT00758498|144736751|SUPERIORITY_OR_OTHER|||||||0.0022|||||||ANCOVA|Analysis of treatment comparisons is based on analysis of covariance (ANCOVA) with treatment as a factor and baseline value as a covariate||||||0.0022
72604278|NCT00758498|144736751|SUPERIORITY_OR_OTHER|||||||0.0033|||||||ANCOVA|Analysis of treatment comparisons was based on ANCOVA with treatment as a factor and the baseline as a covariate||||||0.0033
72604279|NCT00758498|144736757|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|Analysis of treatment comparisons is based on analysis of covariance (ANCOVA) with treatment as factor and baseline value as a covariate.||||||<0.0001
72604280|NCT00758498|144736757|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|Analysis of treatment comparisons is based on ANCOVA with treatment as factor and baseline value as a covariate||||||<0.0001
72604281|NCT00758498|144736758|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|Analysis of treatment comparisons is based on analysis of covariance (ANCOVA) with treatment as a factor and baseline value as a covariate||||||<0.0001
72604282|NCT00758498|144736758|SUPERIORITY_OR_OTHER||Least square mean||||<|0.0001|||||||ANCOVA|Analysis of treatment comparisons is based on ANCOVA with treatment as a factor and the baseline value as a covariate||||||<0.0001
72604283|NCT00758498|144736759|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|Analysis of treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||||<0.0001
72604284|NCT00758498|144736759|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|Analysis of treatment comparisons is from an ANCOVA with treatment as a factor and the baseline value as a covariate||||||<0.0001
72604285|NCT00758498|144736761|SUPERIORITY_OR_OTHER|||||||0.8262|||||||ANOVA|||||||0.8262
72604286|NCT00758498|144736761|SUPERIORITY_OR_OTHER|||||||0.004|||||||ANOVA|||||||0.0040
72604287|NCT00758498|144736762|SUPERIORITY_OR_OTHER|||||||0.9595|||||||ANOVA|||||||0.9595
72604288|NCT00758498|144736762|SUPERIORITY_OR_OTHER||Least square mean|||||0.3539|||||||ANOVA|||||||0.3539
72604289|NCT00758498|144736763|SUPERIORITY_OR_OTHER|||||||0.1038|||||||ANOVA|||||||0.1038
72604290|NCT00758498|144736763|SUPERIORITY_OR_OTHER|||||||0.8112|||||||ANOVA|||||||0.8112
72604291|NCT01516736|144736787|EQUIVALENCE|The testing procedure was set up in a hierarchical structure, where first equivalence between LA-EP2006 and Neulasta® was assessed (margin ±1 day) and only if this was successfully established, non-inferiority between the two products was tested using a tighter margin of -0.6 days.|Mean Difference (Net)|-0.16||||0.05|TWO_SIDED|95.0|-0.4|0.08|||ANCOVA|The primary endpoints was analyzed with analysis of covariance (ANCOVA).||"The primary objective of the study was to compare LA-EP2006 and Neulasta in terms of the DSN in Cycle 1. It was to be shown in a hierarchical way:~1. that LA-EP2006 is equivalent (margin: ±1 day) to Neulasta® with respect to DSN duration in Cycle 1 and, if this was successfully established,~2. that LA-EP2006 is non-inferior (margin: -0.6 days) to Neulasta® with respect to DSN duration in Cycle 1."||0.08|-0.40|0.05
72604292|NCT01516736|144736787|NON_INFERIORITY|The testing procedure was set up in a hierarchical structure, where first equivalence between LA-EP2006 and Neulasta® was assessed (margin ±1 day) and only if this was successfully established, non-inferiority between the two products was tested using a tighter margin of -0.6 days.|Mean Difference (Net)|-0.16||||0.05|TWO_SIDED|95.0|-0.4|0.08|||ANCOVA|The primary endpoints was analyzed with analysis of covariance (ANCOVA).||"The primary objective of the study was to compare LA-EP2006 and Neulasta in terms of the DSN in Cycle 1. It was to be shown in a hierarchical way:~1. that LA-EP2006 is equivalent (margin: ±1 day) to Neulasta® with respect to DSN duration in Cycle 1 and, if this was successfully established,~2. that LA-EP2006 is non-inferior (margin: -0.6 days) to Neulasta® with respect to DSN duration in Cycle 1."||0.08|-0.40|0.05
72604293|NCT01781208|144736816|SUPERIORITY_OR_OTHER||||||<|0.0001||||||r=0.68, unadjusted for age, gender, and histologic inflammation.|Pearson Correlation|||Continuous data were summarized using means and standard deviations. The relationship between ARFI (VTQ) liver shear wave speed and liver histologic fibrosis score were assessed using Pearson correlation. No a priori power analysis was performed.||||<0.0001
72604294|NCT01781208|144736816|SUPERIORITY_OR_OTHER||||||<|0.0001||||||r=0.73, unadjusted for age, gender, and histologic inflammation score|Pearson Correlation|||Continuous data were summarized using means and standard deviations. The relationship between ARFI (VTIQ) liver shear wave speed and liver histologic fibrosis score were assessed using Pearson correlation. No a priori power analysis was performed.||||<0.0001
72604295|NCT02683239|144736842|SUPERIORITY||Least Squares Mean|-0.73|STANDARD_ERROR_OF_MEAN|0.221|=|0.001|TWO_SIDED|95.0|-1.159|-0.293|||Mixed Models Analysis|||||-0.293|-1.159|= 0.0010
72604296|NCT02683239|144736842|SUPERIORITY||Least Squares Mean|-1.22|STANDARD_ERROR_OF_MEAN|0.217|<|0.0001|TWO_SIDED|95.0|-1.646|-0.793|||Mixed Models Analysis|||||-0.793|-1.646|< 0.0001
72604297|NCT02683239|144736842|SUPERIORITY||Least Squares Mean|-1.23|STANDARD_ERROR_OF_MEAN|0.222|<|0.0001|TWO_SIDED|95.0|-1.664|-0.793|||Mixed Models Analysis|||||-0.793|-1.664|< 0.0001
72604298|NCT02683239|144736842|SUPERIORITY||Least Squares Mean|-1.04|STANDARD_ERROR_OF_MEAN|0.222|<|0.0001|TWO_SIDED|95.0|-1.477|-0.606|||Mixed Models Analysis|||||-0.606|-1.477|< 0.0001
72604299|NCT02683239|144736843|SUPERIORITY||Least Squares Mean|-0.74|STANDARD_ERROR_OF_MEAN|0.218|=|0.0007|TWO_SIDED|95.0|-1.163|-0.309|||Mixed Models Analysis|||||-0.309|-1.163|= 0.0007
72604300|NCT02683239|144736843|SUPERIORITY||Least Squares Mean|-1.2|STANDARD_ERROR_OF_MEAN|0.218|<|0.0001|TWO_SIDED|95.0|-1.624|-0.768|||Mixed Models Analysis|||||-0.768|-1.624|< 0.0001
72604301|NCT02683239|144736843|SUPERIORITY||Least Squares Mean|-1.26|STANDARD_ERROR_OF_MEAN|0.223|<|0.0001|TWO_SIDED|95.0|-1.698|-0.822|||Mixed Models Analysis|||||-0.822|-1.698|< 0.0001
72604302|NCT02683239|144736843|SUPERIORITY||Least Squares Mean|-1.13|STANDARD_ERROR_OF_MEAN|0.222|<|0.0001|TWO_SIDED|95.0|-1.564|-0.695|||Mixed Models Analysis|||||-0.695|-1.564|< 0.0001
72604303|NCT02683239|144736844|SUPERIORITY||Least Squares Mean|-0.2|STANDARD_ERROR_OF_MEAN|0.09|=|0.023|TWO_SIDED|95.0|-0.38|-0.028|||Mixed Models Analysis|||||-0.028|-0.380|= 0.0230
72604304|NCT02683239|144736844|SUPERIORITY||Least Squares Mean|-0.27|STANDARD_ERROR_OF_MEAN|0.088|=|0.0025|TWO_SIDED|95.0|-0.437|-0.093|||Mixed Models Analysis|||||-0.093|-0.437|= 0.0025
72604305|NCT02683239|144736844|SUPERIORITY||Least Squares Mean|-0.32|STANDARD_ERROR_OF_MEAN|0.09|=|0.0003|TWO_SIDED|95.0|-0.496|-0.145|||Mixed Models Analysis|||||-0.145|-0.496|= 0.0003
72604306|NCT02683239|144736844|SUPERIORITY||Least Squares Mean|-0.29|STANDARD_ERROR_OF_MEAN|0.089|=|0.001|TWO_SIDED|95.0|-0.466|-0.118|||Mixed Models Analysis|||||-0.118|-0.466|= 0.0010
72604307|NCT00873730|144736855|SUPERIORITY_OR_OTHER|||||||0.6031|||||||Chi-squared|||||||0.6031
72604308|NCT00873730|144736856|SUPERIORITY_OR_OTHER|||||||0.9166|||||||Chi-squared|||||||0.9166
72604309|NCT00873730|144736857|SUPERIORITY_OR_OTHER|||||||0.7564|||||||Chi-squared|||||||0.7564
72604310|NCT00873730|144736858|SUPERIORITY_OR_OTHER|||||||0.3266|||||||Chi-squared|||||||0.3266
72604311|NCT00873730|144736859|SUPERIORITY_OR_OTHER|||||||0.7481|||||||Chi-squared|||||||0.7481
72604312|NCT00873730|144736860|SUPERIORITY_OR_OTHER|||||||0.7721|||||||Chi-squared|||||||0.7721
72604313|NCT00873730|144736861|SUPERIORITY_OR_OTHER|||||||0.666|||||||Wilcoxon (Mann-Whitney)|||Analysis provided for Nocturnal Back Pain.||||0.6660
72604314|NCT00873730|144736861|SUPERIORITY_OR_OTHER|||||||0.5364|||||||Wilcoxon (Mann-Whitney)|||Analysis provided for Overall Spinal Pain.||||0.5364
72604315|NCT00873730|144736862|SUPERIORITY_OR_OTHER|||||||0.9426|||||||Wilcoxon (Mann-Whitney)|||Analysis provided for the Physician Global Assessment.||||0.9426
72604316|NCT00873730|144736862|SUPERIORITY_OR_OTHER|||||||0.4969|||||||Wilcoxon (Mann-Whitney)|||Analysis provided for the Patient Global Assessment.||||0.4969
72604317|NCT00873730|144736863|SUPERIORITY_OR_OTHER|||||||0.6687|||||||Wilcoxon (Mann-Whitney)|||||||0.6687
72604318|NCT00873730|144736864|SUPERIORITY_OR_OTHER|||||||0.6739|||||||Wilcoxon (Mann-Whitney)|||||||0.6739
72604319|NCT00873730|144736865|SUPERIORITY_OR_OTHER|||||||0.2772|||||||Wilcoxon (Mann-Whitney)|||||||0.2772
72604320|NCT00873730|144736866|SUPERIORITY_OR_OTHER|||||||0.156|||||||Wilcoxon (Mann-Whitney)|||||||0.1560
72604321|NCT00873730|144736867|SUPERIORITY_OR_OTHER|||||||0.2099|||||||Chi-squared|||Analysis provided for Mobility.||||0.2099
72604322|NCT00873730|144736867|SUPERIORITY_OR_OTHER|||||||0.8009|||||||Chi-squared|||Analysis provided for Self-care.||||0.8009
72604323|NCT00873730|144736867|SUPERIORITY_OR_OTHER|||||||0.429|||||||Chi-squared|||Analysis provided for Usual activities.||||0.4290
72604324|NCT00873730|144736867|SUPERIORITY_OR_OTHER|||||||0.0461|||||||Chi-squared|||Analysis provided for Pain/Discomfort.||||0.0461
72604325|NCT00873730|144736867|SUPERIORITY_OR_OTHER|||||||0.562|||||||Chi-squared|||Analysis provided for Anxiety/Depression.||||0.5620
72604326|NCT00873730|144736868|SUPERIORITY_OR_OTHER|||||||0.3476|||||||Wilcoxon (Mann-Whitney)|||Analysis provided for Physical functioning.||||0.3476
72604327|NCT00873730|144736868|SUPERIORITY_OR_OTHER|||||||0.9045|||||||Wilcoxon (Mann-Whitney)|||Analysis provided for Physical role limitations.||||0.9045
72604328|NCT00873730|144736868|SUPERIORITY_OR_OTHER|||||||0.8558|||||||Wilcoxon (Mann-Whitney)|||Analysis provided for Bodily pain.||||0.8558
72604329|NCT00873730|144736868|SUPERIORITY_OR_OTHER|||||||0.3123|||||||Wilcoxon (Mann-Whitney)|||Analysis provided for General health.||||0.3123
72604330|NCT00873730|144736868|SUPERIORITY_OR_OTHER|||||||0.3327|||||||Wilcoxon (Mann-Whitney)|||Analysis provided for Vitality.||||0.3327
72604331|NCT00873730|144736868|SUPERIORITY_OR_OTHER|||||||0.8334|||||||Wilcoxon (Mann-Whitney)|||Analysis provided for Social functioning.||||0.8334
72604332|NCT00873730|144736868|SUPERIORITY_OR_OTHER|||||||0.7998|||||||Wilcoxon (Mann-Whitney)|||Analysis provided for Emotional role limitations.||||0.7998
72604333|NCT00873730|144736868|SUPERIORITY_OR_OTHER|||||||0.7125|||||||Wilcoxon (Mann-Whitney)|||Analysis provided for Mental health.||||0.7125
72604334|NCT00873730|144736870|SUPERIORITY_OR_OTHER|||||||0.7404|||||||Wilcoxon (Mann-Whitney)|||||||0.7404
72604335|NCT04878055|144736882|SUPERIORITY||Odds Ratio (OR)|1.626||||0.216|TWO_SIDED|95.0|0.752|3.514|||Two-sided regression, Logistic|||Analysis is based on logistic regression model with Multiple Imputation under missing not at random using retrieve dropouts with proportion of patients alive and free of respiratory failure at Day 28 as dependent variable, treatment, age group, gender and presence of concomitant disease at baseline as qualitative independent variables. Site is considered as random effects that vary randomly among patients.||3.514|0.752|0.216
72604336|NCT04878055|144736883|SUPERIORITY|||||||0.377|||||||Chi-squared|Comparison between treatment arms is performed by means of a Chi-squared test.||||||0.377
72604337|NCT04878055|144736884|SUPERIORITY|Analysis is based on logistic regression model with proportion of patients died up to Date 28 as dependent variable, treatment, age group, gender and presence of concomitant disease at baseline as qualitative independent variables. Site is considered as random effects that vary randomly among patients.|Odds Ratio (OR)|0.468||||0.17|TWO_SIDED|95.0|0.158|1.386|||Two-sided regression, Logistic|||||1.386|0.158|0.17
72604338|NCT04878055|144736885|SUPERIORITY||Odds Ratio (OR)|0.561||||0.168|TWO_SIDED|95.0|0.247|1.277|||Regression, Logistic|||||1.277|0.247|0.168
72604339|NCT04878055|144736886|SUPERIORITY|Estimates are calculated using a nonparametric method for cumulative incidence function with competing risks data. Estimates were calculated taking into account the following competing risks: Death, discontinuation for AEs and patient transferred to another institution.||||||0.167|||||||Gray's Test|||Until Day 28||||0.167
72604340|NCT04878055|144736887|SUPERIORITY|||||||0.55||||||Comparison between treatment arms is performed by means of a Fisher's Exact test.|Fisher Exact|||At Day 3 - please note that the number of subjects is 268 (180+88) and not 270.||||0.55
72604341|NCT04878055|144736887|SUPERIORITY|||||||0.128|||||||Chi-squared|Comparison between treatment arms is performed by means of a Chi-squared mean.||At Day 7 - Please note that the total of subjects in this analysis is not 270 but 266 (n=179 in the Reparixin group and n=87 in the placebo group).||||0.128
72604342|NCT04878055|144736887|SUPERIORITY|||||||0.235|||||||Chi-squared|Comparison between treatment arms is performed by means of a Chi-squared test.||At Day 14 - Please note that the total of subjects in this analysis is not 270 but 256 (n=173 in the Reparixin group and n=83 in the placebo group).||||0.235
72604343|NCT04878055|144736887|SUPERIORITY|||||||0.281|||||||Chi-squared|Comparison between treatment arms is performed by means of a Chi-squared test.||At Day 21 - Please note that the total of subjects in this analysis is not 270 but 255 (n=172 in the Reparixin group and n=83 in the placebo group).||||0.281
72604344|NCT04878055|144736887|SUPERIORITY|||||||0.273|||||||Chi-squared|Comparison between treatment arms is performed by means of a Chi-squared test.||At Day 90 - Please note that the total of subjects in this analysis is not 270 but 50 (n=33 in the Reparixin group and n=17 in the placebo group).||||0.273
72604345|NCT04878055|144736888|SUPERIORITY|||||||0.047||||||Comparison between treatment arms is performed by means of two-sample Mann-Whitney U test.|Wilcoxon (Mann-Whitney)|||At Day 3 - Please note that the number of subjects in this analysis is not 270 but 255||||0.047
72604346|NCT04878055|144736888|SUPERIORITY|||||||0.262|||||||Wilcoxon (Mann-Whitney)|Comparison between treatment arms is performed by means of two-sample Mann-Whitney U test.||||||0.262
72604347|NCT04878055|144736888|SUPERIORITY|||||||0.367|||||||Wilcoxon (Mann-Whitney)|Comparison between treatment arms is performed by means of two-sample Mann-Whitney U test.||At Day 14 - Please note that the number of subjects in this analysis is not 270 but 209||||0.367
72604348|NCT04878055|144736888|SUPERIORITY|||||||0.882||||||Comparison between treatment arms is performed by means of two-sample Mann-Whitney U test.|Wilcoxon (Mann-Whitney)|||At Day 21 - Please note that the number of subjects in this analysis is not 270 but 176||||0.882
72604349|NCT04878055|144736888|SUPERIORITY|||||||0.19|||||||Wilcoxon (Mann-Whitney)|Comparison between treatment arms is performed by means of two-sample Mann-Whitney U test.||At Day 28 - Please note that the number of subjects in this analysis is not 270 but 190||||0.19
72604350|NCT04878055|144736888|SUPERIORITY|||||||0.161||||||Comparison between treatment arms is performed by means of two-sample Mann-Whitney U test.|Mann-Whitney U test|||At Day 60 - Please note that the number of subjects in this analysis is not 270 but 201||||0.161
72604351|NCT04878055|144736888|SUPERIORITY|||||||0.853|||||||Mann-Whitney U test|Comparison between treatment arms is performed by means of two-sample Mann-Whitney U test.||At Day 90 - Please note that the number of subjects in this analysis is not 270 but 18||||0.853
72604352|NCT04878055|144736888|SUPERIORITY|||||||0.068|||||||Wilcoxon (Mann-Whitney)|Comparison between treatment arms is performed by means of two-sample Mann-Whitney U test.||At EOS - Please note that the number of subjects in this analysis is not 270 but 229||||0.068
72604353|NCT04878055|144736888|SUPERIORITY|||||||0.672|||||||Wilcoxon (Mann-Whitney)|Comparison between treatment arms is performed by means of two-sample Mann-Whitney U test.||At hospital discharge (HD) - Please note that the number of subjects in this analysis is not 270 but 195||||0.672
72604354|NCT04878055|144736888|SUPERIORITY|||||||0.153|||||||Wilcoxon (Mann-Whitney)|Comparison between treatment arms is performed by means of two-sample Mann-Whitney U test.||At end of treatment (EoT) - Please note that the number of subjects in this analysis is not 270 but 241||||0.153
72604355|NCT04878055|144736889|SUPERIORITY|Estimates are calculated using a nonparametric method for cumulative incidence function with competing risks data. The null hypothesis is that the cumulative incidence functions are identical across treatment groups and estimates are calculated taking into consideration the following competing risks: Death, reasons for discontinuation for Adverse events and patient transferred to another institution.||||||0.07|||||||Grey's test|||||||0.07
72604356|NCT04878055|144736890|SUPERIORITY|||||||0.07|||||||Gray's test|||number of patients included in the analysis=25||||0.07
72604357|NCT04878055|144736891|SUPERIORITY|Estimates are calculated using a nonparametric method for cumulative incidence function with competing risks data. The null hypothesis is that the cumulative incidence functions are identical across treatment groups and estimates are calculated taking into consideration the following competing risks: Reasons for discontinuation for Adverse events and patient transferred to another institution.||||||0.668|||||||Gray's test|||Comparison at day 28||||0.668
72604358|NCT04878055|144736892|SUPERIORITY|||||||0.668|||||||Gray's test|||Number of patients included in the analysis = 59||||0.668
72604359|NCT04878055|144736893|SUPERIORITY|||||||0.23|||||||Gray's test|||Estimates are calculated using a nonparametric method for cumulative incidence function with competing risks data. The null hypothesis is that the cumulative incidence functions are identical across treatment groups and estimates are calculated taking into consideration the following competing risks: Reasons for discontinuation for Adverse events and patient transferred to another institution.||||0.23
72604360|NCT04878055|144736894|SUPERIORITY|||||||0.444|||||||Wilcoxon (Mann-Whitney)|||day 3 - please note that the number of subjects in this analysis is not 270 but 255||||0.444
72604361|NCT04878055|144736894|SUPERIORITY|||||||0.357|||||||Wilcoxon (Mann-Whitney)|||day 7 - please note that the number of subjects in this analysis is not 270 but 246||||0.357
72604362|NCT04878055|144736894|SUPERIORITY|||||||0.484|||||||Wilcoxon (Mann-Whitney)|||day 14 - please note that the number of subjects in this analysis is not 270 but 209||||0.484
72604363|NCT04878055|144736894|SUPERIORITY|||||||0.753|||||||Wilcoxon (Mann-Whitney)|||day 21 - please note that the number of subjects in this analysis is not 270 but 176||||0.753
72604364|NCT04878055|144736894|SUPERIORITY|||||||0.26|||||||Wilcoxon (Mann-Whitney)|||day 28 - please note that the number of subjects in this analysis is not 270 but 190||||0.26
72604365|NCT04878055|144736894|SUPERIORITY|||||||0.19|||||||Wilcoxon (Mann-Whitney)|||day 60 - please note that the number of subjects in this analysis is not 270 but 201||||0.19
72604366|NCT04878055|144736894|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||day 90 - please note that the number of subjects in this analysis is not 270 but 18||||1.000
72604367|NCT04878055|144736894|SUPERIORITY|||||||0.074|||||||Wilcoxon (Mann-Whitney)|||EOS - please note that the number of subjects in this analysis is not 270 but 229||||0.074
72604368|NCT04878055|144736894|SUPERIORITY|||||||0.193|||||||two-sample Mann-Whitney U test|||EOT - please note that the number of subjects in this analysis is not 270 but 241||||0.193
72604369|NCT04878055|144736894|SUPERIORITY|||||||0.131|||||||two-sample Mann-Whitney U test|||Hospital discharge - please note that the number of subjects in this analysis is not 270 but 195||||0.131
72604370|NCT04878055|144736895|SUPERIORITY|||||||0.997|||||||Wilcoxon (Mann-Whitney)|||at day 3 - Please note that the number of subjects in this analysis is not 270 but 155.||||0.997
72604371|NCT04878055|144736895|SUPERIORITY|||||||0.712|||||||Wilcoxon (Mann-Whitney)|||at day 7 - Please note that the number of subjects in this analysis is not 270 but 143.||||0.712
72604372|NCT04878055|144736895|SUPERIORITY|||||||0.241|||||||Wilcoxon (Mann-Whitney)|||at day 14 - Please note that the number of subjects in this analysis is not 270 but 115.||||0.241
72604373|NCT04878055|144736895|SUPERIORITY|||||||0.528|||||||Wilcoxon (Mann-Whitney)|||at day 21 - Please note that the number of subjects in this analysis is not 270 but 92.||||0.528
72604374|NCT04878055|144736895|SUPERIORITY|||||||0.814|||||||Wilcoxon (Mann-Whitney)|||at day 28 - Please note that the number of subjects in this analysis is not 270 but 106.||||0.814
72604375|NCT04878055|144736895|SUPERIORITY|||||||0.242|||||||Wilcoxon (Mann-Whitney)|||at EOT - Please note that the number of subjects in this analysis is not 270 but 115.||||0.242
72604376|NCT04878055|144736895|SUPERIORITY|||||||0.722|||||||Wilcoxon (Mann-Whitney)|||at hospital discharge (HD) - Please note that the number of subjects in this analysis is not 270 but 65.||||0.722
72604377|NCT04878055|144736896|SUPERIORITY|||||||0.053|||||||two-sample Mann-Whitney U test|||at day 3 - Please note that the number of subjects in this analysis is not 270, but it is 246.||||0.053
72604378|NCT04878055|144736896|SUPERIORITY|||||||0.245|||||||two-sample Mann-Whitney U test|||at day 7 - Please note that the number of subjects in this analysis is not 270, but it is 225.||||0.245
72604379|NCT04878055|144736896|SUPERIORITY|||||||0.067|||||||two-sample Mann-Whitney U test|||at day 14 - Please note that the number of subjects in this analysis is not 270, but it is 118.||||0.067
72604380|NCT04878055|144736896|SUPERIORITY|||||||0.051|||||||two-sample Mann-Whitney U test|||at day 21 - Please note that the number of subjects in this analysis is not 270, but it is 54.||||0.051
72604381|NCT04878055|144736896|SUPERIORITY|||||||0.684|||||||two-sample Mann-Whitney U test|||at day 28 - Please note that the number of subjects in this analysis is not 270, but it is 32.||||0.684
72604382|NCT04878055|144736896|SUPERIORITY|||||||1|||||||two-sample Mann-Whitney U test|||at EOS - Please note that the number of subjects in this analysis is not 246, but it is 14.||||1.00
72604383|NCT04878055|144736896|SUPERIORITY|||||||0.48|||||||two-sample Mann-Whitney U test|||at Day 60 - Please note that the number of subjects in this analysis is not 246, but it is 3.||||0.48
72604384|NCT04878055|144736896|SUPERIORITY|||||||0.638|||||||two-sample Mann-W hitney U test|||at Hospital discharge - Please note that the number of subjects in this analysis is 152.||||0.638
72604385|NCT04878055|144736896|SUPERIORITY|||||||0.137|||||||two-sample Mann-W hitney U test|||at EoT - Please note that the number of subjects in this analysis is 212.||||0.137
72604386|NCT04878055|144736897|SUPERIORITY|||||||0.399|||||||Wilcoxon (Mann-Whitney)|||at day 3 - Please note that the number of subjects in this analysis is not 270, but it is 157||||0.399
72604387|NCT04878055|144736897|SUPERIORITY|||||||0.07|||||||Wilcoxon (Mann-Whitney)|||at day 7 - Please note that the number of subjects in this analysis is not 270, but it is 139||||0.07
72604388|NCT04878055|144736897|SUPERIORITY|||||||0.4|||||||Wilcoxon (Mann-Whitney)|||at day 14 - Please note that the number of subjects in this analysis is not 270, but it is 73||||0.4
72604389|NCT04878055|144736897|SUPERIORITY|||||||0.517|||||||Wilcoxon (Mann-Whitney)|||at day 21 - Please note that the number of subjects in this analysis is not 270, but it is 23||||0.517
72604390|NCT04878055|144736897|SUPERIORITY|||||||0.445|||||||Wilcoxon (Mann-Whitney)|||at day 28 - Please note that the number of subjects in this analysis is not 270, but it is 17||||0.445
72604391|NCT04878055|144736897|SUPERIORITY|||||||0.324|||||||Wilcoxon (Mann-Whitney)|||at EoT - Please note that the number of subjects in this analysis is not 270, but it is 113||||0.324
72604392|NCT04878055|144736897|SUPERIORITY|||||||0.752|||||||Wilcoxon (Mann-Whitney)|||at Hospital discharge - Please note that the number of subjects in this analysis is not 270, but it is 67.||||0.752
72604393|NCT04878055|144736898|SUPERIORITY|||||||0.447|||||||two-sample Mann-Whitney U test|||Please note that the number of patients in this analysis is not 270 but 255, because patients who used supplement oxygen were 174 in the Reparixin group and 81 in the placebo group.||||0.447
72604394|NCT04878055|144736899|SUPERIORITY|||||||0.065||||||Comparison between treatment arms is performed by means of a Chi-squared test|Chi-squared|||At day 28 - Please note that the number of patients in this analysis is not 270 but 245, because patients requiring IMV or ECMO were 163 in the Reparixin group and 82 in the placebo group.||||0.065
72416253|NCT01972841|144343306|SUPERIORITY||Least squares mean difference|-2.21|STANDARD_ERROR_OF_MEAN|0.76||0.012|TWO_SIDED|95.0|-3.7|-0.71|||Stratified rank ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (mirabegron 50 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||-0.71|-3.70|0.012
72604395|NCT04878055|144736899|SUPERIORITY|||||||0.072|||||||Chi-squared|Comparison between treatment arms is performed by means of a Chi-squared test||||||0.072
72604396|NCT04878055|144736900|SUPERIORITY|||||||0.485||||||Number of subjects included in analysis: 98|two-sample Mann-Whitney U test|||||||0.485
72604397|NCT04878055|144736901|SUPERIORITY|||||||0.267|||||||two-sample Mann-Whitney U test|||Number of subjects included in analysis: 17||||0.267
72604398|NCT04878055|144736902|SUPERIORITY|||||||0.137|||||||two-sample Mann-Whitney U test|||||||0.137
72604399|NCT04878055|144736903|SUPERIORITY|||||||0.002|||||||two-sample Mann-Whitney U test|||at day 3 - Please note that the number of subjects in this analysis is 168||||0.002
72604400|NCT04878055|144736903|SUPERIORITY|||||||0.943|||||||two-sample Mann-Whitney U test|||at day 7 - Please note that the number of subjects in this analysis is not 168, but it is 146||||0.943
72604401|NCT04878055|144736903|SUPERIORITY|||||||0.88|||||||two-sample Mann-Whitney U test|||at day 14 - Please note that the number of subjects in this analysis is not 168, but it is 76||||0.88
72604402|NCT04878055|144736903|SUPERIORITY|||||||0.458|||||||Wilcoxon (Mann-Whitney)|||at day 21 - Please note that the number of subjects in this analysis is not 168, but it is 38||||0.458
72604403|NCT04878055|144736903|SUPERIORITY|||||||0.285|||||||two-sample Mann-Whitney U test|||at day 28 - Please note that the number of subjects in this analysis is not 168, but it is 23.||||0.285
72604404|NCT04878055|144736903|SUPERIORITY|||||||0.885|||||||two-sample Mann-Whitney U test|||at EOS - Please note that the number of subjects in this analysis is not 168, but it is 8||||0.885
72604405|NCT04878055|144736903|SUPERIORITY||||||=|0.583|||||||two-sample Mann-Whitney U test|||at HD - Please note that the number of subjects in this analysis is not 270, but it is 74||||= 0.583
72604406|NCT04878055|144736903|SUPERIORITY|||||||0.5|||||||two-sample Mann-Whitney U test|||at End of treatment - Please note that the number of subjects in this analysis is not 270, but it is 131.||||0.5
72604407|NCT04878055|144736904|SUPERIORITY|||||||0.005||||||Comparison between treatment arms is performed by means of two-sample Mann-Whitney U test|Mann-Whitney U test|||at day 3 - Please note that the number of subjects in this analysis is not 270, but it is 245||||0.005
72604408|NCT04878055|144736904|SUPERIORITY|||||||0.283||||||Comparison between treatment arms is performed by means of two-sample Mann-Whitney U test.|Mann-Whitney U test|||at day 7 - Please note that the number of subjects in this analysis is not 270, but it is 221||||0.283
72604409|NCT04878055|144736904|SUPERIORITY|||||||0.512||||||Comparison between treatment arms is performed by means of two-sample Mann-Whitney U test.|Mann-Whitney U test|||at day 14 - Please note that the number of subjects in this analysis is not 270, but it is 117||||0.512
72604410|NCT04878055|144736904|SUPERIORITY|||||||0.174|||||||Mann-Whitney U test|Comparison between treatment arms is performed by means of two-sample Mann-Whitney U test.||at day 21 - Please note that the number of subjects in this analysis is not 270, but it is 51||||0.174
72604411|NCT04878055|144736904|SUPERIORITY|at EOT - Please note that the number of subjects in this analysis is not 270, but it is 206||||||0.133|||||||Mann-Whitney U test|Comparison between treatment arms is performed by means of two-sample Mann-Whitney U test.||||||0.133
72604412|NCT04878055|144736904|SUPERIORITY|||||||0.009|||||||Mann-Whitney U test|Comparison between treatment arms is performed by means of two-sample Mann-Whitney U test.||at day 28 ± 2 - Please note that the number of subjects in this analysis is not 270, but it is 29||||0.009
72604413|NCT04878055|144736904|SUPERIORITY|||||||0.593|||||||Mann-Whitney U test|Comparison between treatment arms is performed by means of two-sample Mann-Whitney U test.||to HD - Please note that the number of subjects in this analysis is not 270, but it is 144||||0.593
72604414|NCT04878055|144736904|SUPERIORITY|||||||0.54|||||||Mann-Whitney U test|Comparison between treatment arms is performed by means of two-sample Mann-Whitney U test.||to day 60 - Please note that the number of subjects in this analysis is not 270, but it is 3||||0.540
72604415|NCT04878055|144736904|SUPERIORITY|||||||0.224|||||||Mann-Whitney U test|Comparison between treatment arms is performed by means of two-sample Mann-Whitney U test.||to EOS - Please note that the number of subjects in this analysis is not 270, but it is 13||||0.224
72604416|NCT04878055|144736905|SUPERIORITY|||||||0.68|||||||Mann-Whitney U test|Comparison between treatment arms is performed by means of two-sample Mann-Whitney U test.||to day 3 - Please note that the number of subjects in this analysis is not 270, but it is 15||||0.68
72604417|NCT04878055|144736905|SUPERIORITY|||||||0.272||||||Comparison between treatment arms is performed by means of two-sample Mann-Whitney U test.|Mann-Whitney U test|||to day 7 - Please note that the number of subjects in this analysis is not 270, but it is 13||||0.272
72604418|NCT04878055|144736905|SUPERIORITY|||||||1||||||Comparison between treatment arms is performed by means of two-sample Mann-Whitney U test.|Mann-Whitney U test|||to day 14 - Please note that the number of subjects in this analysis is not 270, but it is 13||||1.000
72604419|NCT04878055|144736905|SUPERIORITY|||||||0.903||||||Comparison between treatment arms is performed by means of two-sample Mann-Whitney U test.|Mann-Whitney U test|||to day 21 - Please note that the number of subjects in this analysis is not 270, but it is 9||||0.903
72604420|NCT04878055|144736905|SUPERIORITY|||||||0.432||||||Comparison between treatment arms is performed by means of two-sample Mann-Whitney U test.|Mann-Whitney U test|||to EOT - Please note that the number of subjects in this analysis is not 270, but it is 13||||0.432
72604421|NCT04878055|144736905|SUPERIORITY|||||||0.105||||||Comparison between treatment arms is performed by means of two-sample Mann-Whitney U test.|Mann-Whitney U test|||to day 28 - Please note that the number of subjects in this analysis is not 270, but it is 6||||0.105
72604422|NCT04878055|144736905|SUPERIORITY|||||||0.551||||||Comparison between treatment arms is performed by means of two-sample Mann-Whitney U test.|Mann-Whitney U test|||to HD - Please note that the number of subjects in this analysis is not 270, but it is 8||||0.551
72604423|NCT04878055|144736906|SUPERIORITY||Odds Ratio (OR)|0.52||||0.232|TWO_SIDED|95.0|0.178|1.522||Analysis is based on logistic regression model with proportion of patients died up to Day 60 as dependent variable, treatment, age group, gender and presence of concomitant disease at baseline as qualitative independent variables.|Regression, Logistic|||up to day 60||1.522|0.178|0.232
72604424|NCT04878055|144736906|SUPERIORITY|Analysis is based on logistic regression model with proportion of patients died up to Day 90 as dependent variable, treatment, age group, gender and presence of concomitant disease at baseline as qualitative independent variables.|Odds Ratio (OR)|0.246||||0.158|TWO_SIDED|95.0|0.034|1.782|||Regression, Logistic|||Up to Day 90||1.782|0.034|0.158
72604425|NCT04878055|144736907|SUPERIORITY|Freedom from (time to) death or respiratory failure (need of invasive mechanical ventilation or ECMO or admission to ICU linked to worsening of respiratory parameters compared to baseline) up to Day 90 was performed using the same Kaplan-Meier analysis and the one-sided log-rank test that were used to test for differences between groups||||||0.33607|||||||Log Rank|||||||0.33607
72604426|NCT02372344|144736911|SUPERIORITY_OR_OTHER||Geometric least square (LS) mean ratio|0.64|||||TWO_SIDED|95.0|0.54|0.77||||||Total EPA: Ratio of Fasting to After meal. Primary comparisons for total EPA were based on a linear mixed-effect model. This model included log-transformed PK parameter (AUC) as a response variable and treatment, sequence and period as fixed categorical effects, and subject nested within sequence as a random categorical effect.||0.77|0.54|
72604427|NCT02372344|144736911|SUPERIORITY_OR_OTHER||Geometric LS mean ratio|0.71|||||TWO_SIDED|95.0|0.59|0.86||||||Total EPA: Ratio of Before meal to After meal. Primary comparisons for total EPA were based on a linear mixed-effect model. This model included log-transformed PK parameter (AUC) as a response variable and treatment, sequence and period as fixed categorical effects, and subject nested within sequence as a random categorical effect.||0.86|0.59|
72604428|NCT02372344|144736912|SUPERIORITY_OR_OTHER||Geometric LS mean ratio|0.35|||||TWO_SIDED|95.0|0.27|0.47||||||Total EPA: Ratio of Fasting to After meal. Primary comparisons for total EPA were based on a linear mixed-effect model. This model included log-transformed PK parameter (Cmax) as a response variable and treatment, sequence and period as fixed categorical effects, and subject nested within sequence as a random categorical effect.||0.47|0.27|
72604429|NCT02372344|144736912|SUPERIORITY_OR_OTHER||Geometric LS mean ratio|0.44|||||TWO_SIDED|95.0|0.33|0.59||||||Total EPA: Ratio of Before meal to After meal. Primary comparisons for total EPA were based on a linear mixed-effect model. This model included log-transformed PK parameter (Cmax) as a response variable and treatment, sequence and period as fixed categorical effects, and subject nested within sequence as a random categorical effect.||0.59|0.33|
72604430|NCT02372344|144736912|SUPERIORITY_OR_OTHER||Geometric LS mean ratio|0.46|||||TWO_SIDED|95.0|0.36|0.57||||||Total DHA: Ratio of Fasting to After meal. Primary comparisons for total DHA were based on a linear mixed-effect model. This model included log-transformed PK parameter (Cmax) as a response variable and treatment, sequence and period as fixed categorical effects, and subject nested within sequence as a random categorical effect.||0.57|0.36|
72604431|NCT02372344|144736912|SUPERIORITY_OR_OTHER||Geometric LS mean ratio|0.57|||||TWO_SIDED|95.0|0.45|0.71||||||Total DHA: Ratio of Before meal to After meal. Primary comparisons for total DHA were based on a linear mixed-effect model. This model included log-transformed PK parameter (Cmax) as a response variable and treatment, sequence and period as fixed categorical effects, and subject nested within sequence as a random categorical effect.||0.71|0.45|
72604432|NCT02372344|144736913|SUPERIORITY_OR_OTHER||Geometric LS mean ratio|0.56|||||TWO_SIDED|95.0|0.45|0.69||||||Total EPA: Ratio of Fasting to After meal. Primary comparisons for total EPA were based on a linear mixed-effect model. This model included log-transformed PK parameter (AUC0-72) as a response variable and treatment, sequence and period as fixed categorical effects, and subject nested within sequence as a random categorical effect.||0.69|0.45|
72604433|NCT02372344|144736913|SUPERIORITY_OR_OTHER||Geometric LS mean ratio|0.55||||||95.0|0.44|0.69||||||Total EPA: Ratio of Before Meal to After meal. Primary comparisons for total EPA were based on a linear mixed-effect model. This model included log-transformed PK parameter (AUC0-72) as a response variable and treatment, sequence and period as fixed categorical effects, and subject nested within sequence as a random categorical effect.||0.69|0.44|
72604434|NCT02372344|144736913|SUPERIORITY_OR_OTHER||Geometric LS mean ratio|0.87|||||TWO_SIDED|95.0|0.73|1.04||||||Total DHA: Ratio of Fasting to After meal. Primary comparisons for total DHA were based on a linear mixed-effect model. This model included log-transformed PK parameter (AUC0-72) as a response variable and treatment, sequence and period as fixed categorical effects, and subject nested within sequence as a random categorical effect.||1.04|0.73|
72604435|NCT02372344|144736913|SUPERIORITY_OR_OTHER||Geometric LS mean ratio|0.86|||||TWO_SIDED|95.0|0.72|1.02||||||Total DHA: Ratio of Before meal to After meal. Primary comparisons for total DHA were based on a linear mixed-effect model. This model included log-transformed PK parameter (AUC0-72) as a response variable and treatment, sequence and period as fixed categorical effects, and subject nested within sequence as a random categorical effect.||1.02|0.72|
72604436|NCT02427841|144736944|SUPERIORITY|Tested against the standard R0 rate of 37%. Given all evaluable patients are included in the denominator, R0 of 56% was not achieved. Specifically, of the 19 evaluable patients, 11 proceeded to surgery. Of the 11 who underwent surgery, 8 \[42% of those enrolled, but 72.7% of those resected\] achieved R0 resection.|binomial|42.0||||0.404|TWO_SIDED|95.0|20.0|67.0||Study was underpowered.|2-sided exact binomial||Test for superiority over standard R0 resection rate of 37%. Study was closed due to slow enrollment, meaning the primary endpoint was underpowered with only 19 of an expected 44 patients enrolled.|Study closed early due to lack of enrollment. Study expected to enrolled 44 evaluable patients to achieve 83% power using the 2-sided binomial test at 10% significance. Study enrolled only 19 evaluable patients, meaning the study was underpowered at \< 62%||67|20|.404
72604437|NCT00327717|144736968|SUPERIORITY_OR_OTHER|||||||0.028||95.0|||||ANOVA|||||||0.028
72604438|NCT00327717|144736969|SUPERIORITY_OR_OTHER|||||||0.253||95.0|||||ANOVA|||||||0.253
72604439|NCT00327717|144736970|SUPERIORITY_OR_OTHER|||||||0.211||95.0|||||ANOVA|||||||0.211
72604440|NCT00327717|144736971|SUPERIORITY_OR_OTHER|||||||0.516||95.0|||||ANOVA|||||||0.516
72604441|NCT00327717|144736972|SUPERIORITY_OR_OTHER|||||||0.044|||||||X^2 test|||||||0.044
72604442|NCT00327717|144736973|SUPERIORITY_OR_OTHER|||||||0.09||95.0|||||X^2 test|||||||0.090
72604443|NCT00327717|144736974|SUPERIORITY_OR_OTHER|||||||0.09||95.0|||||X^2 test|||||||0.090
72604444|NCT00327717|144736975|SUPERIORITY_OR_OTHER|||||||0.162||95.0|||||X^2 test|||||||0.162
72604445|NCT00327717|144736976|SUPERIORITY_OR_OTHER|||||||0.678||95.0|||||X^2 test|||||||0.678
72604446|NCT01509612|144736989|SUPERIORITY|||||||0.397|||||||t-test, 2 sided|||||||0.397
72604447|NCT01509612|144736990|SUPERIORITY|||||||0.02|||||||Chi-squared|||Only those groups were compared who received an intervention||||0.02
72604448|NCT00627926|144737009|SUPERIORITY_OR_OTHER||Difference in percentage|23.0|||||TWO_SIDED|95.0|15.9|30.0||||||||30.0|15.9|
72604449|NCT00627926|144737009|SUPERIORITY_OR_OTHER||Difference in percentage|29.2|||||TWO_SIDED|95.0|22.4|36.1||||||||36.1|22.4|
72604450|NCT00627926|144737010|SUPERIORITY_OR_OTHER||Difference in percentage|57.1|||||TWO_SIDED|95.0|51.4|62.8||||||||62.8|51.4|
72604451|NCT00627926|144737010|SUPERIORITY_OR_OTHER||Difference in percentage|58.4|||||TWO_SIDED|95.0|52.7|64.0||||||||64.0|52.7|
72604452|NCT00627926|144737011|SUPERIORITY_OR_OTHER||Difference in percentage|48.8|||||TWO_SIDED|95.0|43.0|54.6||||||||54.6|43.0|
72604453|NCT00627926|144737011|SUPERIORITY_OR_OTHER||Difference in percentage|50.4|||||TWO_SIDED|95.0|44.6|56.2||||||||56.2|44.6|
72604454|NCT00627926|144737012|SUPERIORITY_OR_OTHER||Difference in percentage|35.7|||||TWO_SIDED|95.0|29.0|42.4||||||||42.4|29.0|
72604455|NCT00627926|144737012|SUPERIORITY_OR_OTHER||Difference in percentage|37.5|||||TWO_SIDED|95.0|30.9|44.1||||||||44.1|30.9|
72604456|NCT00627926|144737013|SUPERIORITY_OR_OTHER||Difference in percentage|17.6|||||TWO_SIDED|95.0|11.2|24.0||||||||24.0|11.2|
72604457|NCT00627926|144737013|SUPERIORITY_OR_OTHER||Difference in percentage|23.1|||||TWO_SIDED|95.0|17.0|29.2||||||||29.2|17.0|
72604458|NCT00627926|144737014|SUPERIORITY_OR_OTHER||Difference in percentage|25.5|||||TWO_SIDED|95.0|18.5|32.4||||||||32.4|18.5|
72604459|NCT00627926|144737014|SUPERIORITY_OR_OTHER||Difference in percentage|31.2|||||TWO_SIDED|95.0|24.4|37.9||||||||37.9|24.4|
72604460|NCT00627926|144737015|SUPERIORITY_OR_OTHER||Difference in percentage|25.2|||||TWO_SIDED|95.0|18.2|32.2||||||||32.2|18.2|
72604461|NCT00627926|144737015|SUPERIORITY_OR_OTHER||Difference in percentage|31.7|||||TWO_SIDED|95.0|24.9|38.5||||||||38.5|24.9|
72604462|NCT00627926|144737020|SUPERIORITY_OR_OTHER||Difference in percentage|24.9|||||TWO_SIDED|95.0|17.9|31.9||||||SVR Protocol Defined: undetectable HCV RNA at 24 weeks after the last planned dose of study treatment without any confirmed detectable HCV RNA between end of treatment visit (up to Week 48) and 24 weeks after last planned dose (up to Week 72).||31.9|17.9|
72604463|NCT00627926|144737020|SUPERIORITY_OR_OTHER||Difference in percentage|30.9|||||TWO_SIDED|95.0|24.1|37.7||||||SVR Protocol Defined: undetectable HCV RNA at 24 weeks after the last planned dose of study treatment without any confirmed detectable HCV RNA between end of treatment visit (up to Week 48) and 24 weeks after last planned dose (up to Week 72).||37.7|24.1|
72604464|NCT00627926|144737020|SUPERIORITY_OR_OTHER||Difference in percentage|25.7|||||TWO_SIDED|95.0|18.8|32.6||||||SVR FDA Guidance: undetectable HCV RNA at 24 weeks after the last planned dose of study treatment. Analysis was based only on the HCV RNA assessment in visit window (+/-2 weeks); if there were more than 1 assessment in the window, the last measurement was used.||32.6|18.8|
72604465|NCT00627926|144737020|SUPERIORITY_OR_OTHER||Difference in percentage|32.5|||||TWO_SIDED|95.0|25.9|39.2||||||SVR FDA Guidance: undetectable HCV RNA at 24 weeks after the last planned dose of study treatment. Analysis was based only on the HCV RNA assessment in visit window (+/-2 weeks); if there were more than 1 assessment in the window, the last measurement was used.||39.2|25.9|
72604466|NCT01462110|144737036|SUPERIORITY|The null hypothesis was the Week 4 mean is equal between the two cells. The alternative hypothesis was the Week 4 mean is not equal between the two cells.|Mean Difference (Net)|-0.234|STANDARD_ERROR_OF_MEAN|0.0211|<|0.001|TWO_SIDED|95.0|-0.276|-0.192|||ANCOVA|Terms for treatment as a factor \& baseline as a covariate.||||-0.192|-0.276|<0.001
72604467|NCT01462110|144737037|SUPERIORITY|The null hypothesis was the Week 4 mean is equal between the two cells. The alternative hypothesis was the Week 4 mean is not equal between the two cells.|Mean Difference (Net)|-1.232|STANDARD_ERROR_OF_MEAN|0.0806|<|0.001|TWO_SIDED|95.0|-1.392|-1.071|||ANCOVA|Terms for treatment as a factor \& baseline as a covariate.||||-1.071|-1.392|<0.001
72604468|NCT01462110|144737038|SUPERIORITY|The null hypothesis was the Week 2 mean is equal between the two cells. The alternative hypothesis was the Week 2 mean is not equal between the two cells.|Mean Difference (Net)|-0.106|STANDARD_ERROR_OF_MEAN|0.0173|<|0.001|TWO_SIDED|95.0|-0.14|-0.071|||ANCOVA|Terms for treatment as a factor \& baseline as a covariate.||||-0.071|-0.140|<0.001
72604469|NCT01462110|144737039|SUPERIORITY|The null hypothesis was the Week 2 mean is equal between the two cells. The alternative hypothesis was the Week 2 mean is not equal between the two cells.|Mean Difference (Net)|-0.83|STANDARD_ERROR_OF_MEAN|0.0957|<|0.001|TWO_SIDED|95.0|-1.02|-0.639|||ANCOVA|Terms for treatment as a factor \& baseline as a covariate.||||-0.639|-1.020|<0.001
72604470|NCT01462110|144737040|SUPERIORITY|The null hypothesis was the Week 2 mean is equal between the two cells. The alternative hypothesis was the Week 2 mean is not equal between the two cells.|Mean Difference (Net)|-0.044|STANDARD_ERROR_OF_MEAN|0.0076|<|0.001|TWO_SIDED|95.0|-0.059|-0.029|||ANCOVA|Terms for treatment as a factor \& baseline as a covariate.||||-0.029|-0.059|<0.001
72604471|NCT01462110|144737041|SUPERIORITY|The null hypothesis was the Week 4 mean is equal between the two cells. The alternative hypothesis was the Week 4 mean is not equal between the two cells.|Mean Difference (Net)|-0.06|STANDARD_ERROR_OF_MEAN|0.0087|<|0.001|TWO_SIDED|95.0|-0.078|-0.043|||ANCOVA|Terms for treatment as a factor \& baseline as a covariate.||||-0.043|-0.078|<0.001
72604472|NCT02499120|144737072|SUPERIORITY||Hazard Ratio (HR)|0.82||||0.18|TWO_SIDED|95.0|0.536|1.253||1-sided p-value was from the log-rank test stratified by stratification factors ECOG(Eastern Cooperative Oncology Group) per randomization.|Log Rank|||||1.253|0.536|0.1800
72604473|NCT02499120|144737073|SUPERIORITY||Hazard Ratio (HR)|1.0||||0.4953|TWO_SIDED|95.0|0.669|1.495||1-sided p-value was from the log-rank test stratified by stratification factors ECOG per randomization.|Log Rank|||||1.495|0.669|0.4953
72604474|NCT03705286|144737135|SUPERIORITY||Mean Difference (Final Values)|-0.52|STANDARD_ERROR_OF_MEAN|1.87||0.78|TWO_SIDED|95.0|-4.21|3.17|||Regression, Linear|||We evaluated whether there are differences in the Physical Component Score (PCS) for QOL between the PU-EVAC and PVC treatment groups by comparing their respective mean scores (i.e., mean\[PU-EVAC\] - mean\[PVC\] ). We modeled the data using linear regression and used robust standard error estimates to construct our statistical test and 95% confidence interval estimates. We also estimated the treatment groups' mean quality of life scores with standard error estimates and 95% confidence intervals.||3.17|-4.21|0.78
72604475|NCT03705286|144737135|SUPERIORITY||Mean Difference (Final Values)|-2.98|STANDARD_ERROR_OF_MEAN|2.05||0.15|TWO_SIDED|95.0|-7.03|1.07|||Regression, Linear|||We evaluated whether there are differences in the Mental Component Score (MCS) for QOL between the PU-EVAC and PVC treatment groups by comparing their respective mean scores (i.e., mean\[PU-EVAC\] - mean\[PVC\] ). We modeled the data using linear regression and used robust standard error estimates to construct our statistical test and 95% confidence interval estimates. We also estimated the treatment groups' mean quality of life scores with standard error estimates and 95% confidence intervals.||1.07|-7.03|0.15
72604476|NCT03705286|144737136|SUPERIORITY||Risk Difference (RD)|0.05||||0.05|TWO_SIDED|98.0|-0.07|0.17|||Regression, Logistic|||||0.17|-0.07|0.05
72604477|NCT03705286|144737137|SUPERIORITY||Risk Difference (RD)|0.126||||0.05|TWO_SIDED|95.0|-0.01|0.26|||Regression, Logistic|||We evaluated whether there are differences in the risk of laryngeal injury between the PU-EVAC and PVC treatment groups, comparing their respective risk difference (i.e., probability\[PU-EVAC\] - probability \[PVC\]). We fit a logistic regression model and incorporated robust (i.e., Huber-White heteroskedastic consistent) standard error estimates for our hypothesis test and 95% confidence interval estimates.||0.26|-0.01|0.05
72604478|NCT00534638|144737138|SUPERIORITY||Vaccine effectiveness percentage|49.6||||0.004|TWO_SIDED|95.0|20.1|68.2||An objective was reached if the 2-sided p-value associated to the objective was below 5%.|Cochran-Mantel-Haenszel|||Overall efectiveness against HPV-16/18 Cervarix/Engerix-B B Group vs Engerix-B Group: The analysis of the overall effectiveness of GSK's HPV-16/18 vaccine against HPV-16/18 genital infection in Cervarix/Engerix-B B Group versus Engerix-B Group was based on stratified Mantel-Haenszel adjusted for clustering.||68.2|20.1|0.004
72604479|NCT00534638|144737138|SUPERIORITY||Vaccine effectiveness percentage|23.8||||0.232|TWO_SIDED|95.0|-19.0|51.1||An objective was reached if the 2-sided p-value associated to the objective was below 5%.|Cochran-Mantel-Haenszel|||Overall efectiveness against HPV-16/18 Cervarix/Engerix-B A Group vs Engerix-B Group: The analysis of the overall effectiveness of GSK's HPV-16/18 vaccine against HPV-16/18 genital infection in Cervarix/Engerix-B A Group versus Engerix-B Group was based on stratified Mantel-Haenszel adjusted for clustering.||51.1|-19.0|0.232
72604480|NCT00534638|144737139|SUPERIORITY||Vaccine effectiveness percentage|-52.2||||0.069|TWO_SIDED|95.0|-139.4|3.3||An objective was reached if the 2-sided p-value associated to the objective was below 5%.|Cochran-Mantel-Haenszel|||Overall efectiveness against HPV-16/18 Cervarix/Engerix-B A Group vs Cervarix/Engerix-B B Group: The analysis of the overall effectiveness of GSK's HPV-16/18 vaccine against HPV-16/18 genital infection in Cervarix/Engerix-B A Group versus Cervarix/Engerix-B B was based on stratified Mantel-Haenszel adjusted for clustering.||3.3|-139.4|0.069
72416254|NCT01972841|144343307|SUPERIORITY||Least squares mean difference|-0.24|STANDARD_ERROR_OF_MEAN|0.11||0.134|TWO_SIDED|95.0|-0.46|-0.02|||Stratified rank ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (solifenacin 5 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||-0.02|-0.46|0.134
72604481|NCT02106351|144737154|SUPERIORITY||LS mean difference back transformed|-0.4||||0.0118|TWO_SIDED|||||The 2-tailed significance level was 0.05.|ANCOVA|ANCOVA is performed on the ranked values.||The treatment difference between Dysport 8 U/kg and Dysport 2 U/kg was analysed using an analysis of covariance (ANCOVA) on the ranked changes from baseline. The model included treatment group, the baseline value, the 2 stratification factors (age range and BTX status at baseline) and the pooled centre as fixed effects. The derived least squares (LS) means were back transformed to the original scale and the treatment difference determined.||||0.0118
72604482|NCT02106351|144737154|SUPERIORITY||LS mean difference back transformed|-0.7|||<|0.0001|TWO_SIDED|||||The 2-tailed significance level was 0.05.|ANCOVA|ANCOVA is performed on the ranked values.||The treatment difference between Dysport 16 U/kg and Dysport 2 U/kg was analysed using an ANCOVA on the ranked changes from baseline. The model included treatment group, the baseline value, the 2 stratification factors (age range and BTX status at baseline) and the pooled centre as fixed effects. The derived LS means were back transformed to the original scale and the treatment difference determined.||||<0.0001
72604483|NCT02106351|144737155|SUPERIORITY||LS mean difference back transformed|0.2||||0.2043|TWO_SIDED|||||The two-tailed significance level was 0.05.|ANOVA|ANOVA was performed on ranked values.||The treatment difference between Dysport 8 U/kg and Dysport 2 U/kg was analysed using an analysis of variance (ANOVA) on the rank of the PGA score at TC 1, Week 6. The model included treatment group, the 2 stratification factors (age range and BTX status at baseline) and the centre as fixed effects. The derived LS means were back transformed to the original scale and the treatment difference determined.||||0.2043
72604484|NCT02106351|144737155|SUPERIORITY||LS mean difference back transformed|0.2||||0.188|TWO_SIDED|||||The two-tailed significance level was 0.05.|ANOVA|ANOVA was performed on ranked values.||The treatment difference between Dysport 16 U/kg and Dysport 2 U/kg was analysed using an ANOVA on the rank of the PGA score at TC 1, Week 6. The model included treatment group, the 2 stratification factors (age range and BTX status at baseline) and the centre as fixed effects. The derived LS means were back transformed to the original scale and the treatment difference determined.||||0.1880
72604485|NCT02106351|144737156|SUPERIORITY||LS mean difference|0.5||||0.7648|TWO_SIDED|95.0|-2.7|3.7||The two-tailed significance level was 0.05.|ANOVA|||The treatment difference between Dysport 8 U/kg and Dysport 2 U/kg was analysed using ANOVA on the GAS Total score at TC 1, Week 6. The model included treatment group, the 2 stratification factors (age range and BTX status at baseline) and the centre as fixed effects.||3.7|-2.7|0.7648
72604486|NCT02106351|144737156|SUPERIORITY||LS mean difference|0.5||||0.7429|TWO_SIDED|95.0|-2.6|3.7||The two-tailed significance level was 0.05.|ANOVA|||The treatment difference between Dysport 16 U/kg and Dysport 2 U/kg was analysed using ANOVA on the GAS Total score at TC 1, Week 6. The model included treatment group, the 2 stratification factors (age range and BTX status at baseline) and the centre as fixed effects.||3.7|-2.6|0.7429
72604487|NCT00520039|144737164|SUPERIORITY_OR_OTHER||Odds Ratio, log|1.09|STANDARD_ERROR_OF_MEAN|0.94||0.02|TWO_SIDED|95.0|0.15|2.03|||Chi-squared|df = 1|The denominator of the Odds ratio represents the odds of improvement for the Standard Care Only (SCO) group.|Test of the null hypothesis that there is no improvement in MEE at Visit 3 using tympanogram.||2.03|0.15|0.02
72604488|NCT00520039|144737165|SUPERIORITY_OR_OTHER||Odds Ratio, log|0.31|STANDARD_ERROR_OF_MEAN|1.31||0.32|TWO_SIDED|95.0|-1.0|1.62|||Chi-squared|df = 1|The odds of Resolution of MEE before OMT is represented in the denominator of the odds ratio|||1.62|-1.00|0.32
72604489|NCT00520039|144737166|SUPERIORITY_OR_OTHER||Odds Ratio, log|0.25|STANDARD_ERROR_OF_MEAN|1.03||0.31|TWO_SIDED|95.0|-0.78|1.28|||Chi-squared|df = 1||||1.28|-0.78|.31
72604490|NCT01801111|144737172|OTHER|||||||0.0005|||||||Exact Clopper-Pearson CI|||Tests null hypothesis that the objective response rate (ORR) is equal to 35% versus the alternative hypothesis that the objective response rate was not equal to 35%.||||0.0005
72604491|NCT01801111|144737173|OTHER|||||||0.0599|TWO_SIDED||||||Exact Clopper-Pearson CI|||Tests null hypothesis that the ORR is equal to 35% versus the alternative hypothesis that the objective response rate was not equal to 35%.||||0.0599
72604492|NCT01801111|144737175|OTHER|||||||0.0001|||||||Exact Clopper-Pearson CI|||Tests null hypothesis that the ORR is equal to 35% versus the alternative hypothesis that the objective response rate was not equal to 35%.||||0.0001
72604493|NCT01223937|144737206|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.22||||0.028|TWO_SIDED|95.0|-0.42|-0.02||A priori threshold for significance was p\<=0.05.|ANCOVA|Repeated measures ANCOVA with treatment, visit (including a treatment-by-visit interaction term), and age stratification (\<65, ≥65 years) as factors.||"The trial was to be declared positive only if the 25 μg desmopressin group had a statistically significant positive effect as compared to placebo on both co-primary outcomes.~A summary of mean change in nocturnal voids, assessed longitudinally during 3 months of treatment, is presented below for the FAS using LOCF."||-0.02|-0.42|0.0280
72604494|NCT01223937|144737207|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.85||||0.0061|TWO_SIDED|95.0|1.19|2.86||A priori threshold for significance was p\<=0.05.|Generalized Estimating Equation (GEE)|GEE Method with treatment, visit (including a treatment-by-visit interaction term), and age stratification (\<65, ≥65 years) as factors.||The trial was to be declared positive only if the 25 μg desmopressin group had a statistically significant positive effect as compared to placebo on both co-primary outcomes.||2.86|1.19|0.0061
72604495|NCT01223937|144737208|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3||||0.0104|TWO_SIDED|95.0|-0.54|-0.07||A priori threshold for significance was p\<=0.05.|ANCOVA|ANCOVA of change from baseline adjusted for age (\<65, \>=65) and baseline nocturnal voids, using last observation carried forward.||Change from baseline in the adjusted mean number of nocturnal voids in the FAS using LOCF.||-0.07|-0.54|0.0104
72604496|NCT01223937|144737209|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.73||||0.0586|TWO_SIDED|95.0|0.98|3.05||A priori threshold for significance was p\<=0.05.|Regression, Logistic|Logistical regression of 33% responder status adjusted for age (\<65, \>=65) and baseline nocturnal voids using last observation carried forward.||||3.05|0.98|0.0586
72604497|NCT01223937|144737210|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|49.03||||0.0034|TWO_SIDED|95.0|16.35|81.7||A priori threshold for significance was p\<=0.05.|ANCOVA|ANCOVA of change from baseline adjusted for age (\<65, \>=65) and baseline time to first nocturnal void, using last observation carried forward.||||81.70|16.35|0.0034
72604498|NCT01223937|144737211|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-83.56||||0.0031|TWO_SIDED|95.0|-138.74|-28.38||A priori threshold for significance was p\<=0.05.|ANCOVA|ANCOVA of change from baseline adjusted for age (\<65, \>=65) and baseline nocturnal urine volume, using last observation carried forward.||||-28.38|-138.74|0.0031
72604499|NCT01223937|144737212|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-72.91||||0.1829|TWO_SIDED|95.0|-180.42|34.6||A priori threshold for significance was p\<=0.05.|ANCOVA|ANCOVA of change from baseline adjusted for age (\<65, \>=65) and baseline 24-hour urine volume, using last observation carried forward.||||34.60|-180.42|0.1829
72604500|NCT00765817|144737252|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||||||<0.001
72604501|NCT00765817|144737253|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel|||||||<0.001
72604502|NCT00765817|144737254|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel|||||||<0.001
72604503|NCT00765817|144737255|SUPERIORITY_OR_OTHER|||||||0.174||95.0|||||ANCOVA|||||||0.174
72604504|NCT00765817|144737257|SUPERIORITY_OR_OTHER|||||||0.203||95.0|||||ANCOVA|||||||0.203
72604505|NCT00765817|144737258|SUPERIORITY_OR_OTHER|||||||0.063||95.0|||||ANCOVA|||||||0.063
72604506|NCT00765817|144737259|SUPERIORITY_OR_OTHER|||||||0.745||95.0|||||ANCOVA|||||||0.745
72604507|NCT00765817|144737260|SUPERIORITY_OR_OTHER|||||||0.933||95.0|||||ANCOVA|||||||0.933
72604508|NCT00765817|144737261|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||||||<0.001
72604509|NCT00765817|144737262|SUPERIORITY_OR_OTHER|||||||0.226||95.0|||||ANCOVA|||||||0.226
72604510|NCT00765817|144737263|SUPERIORITY_OR_OTHER|||||||0.026||95.0|||||ANCOVA|||||||0.026
72604511|NCT00765817|144737264|SUPERIORITY_OR_OTHER|||||||0.07||95.0|||||ANCOVA|||||||0.070
72604512|NCT00765817|144737265|SUPERIORITY_OR_OTHER|||||||0.011||95.0|||||ANCOVA|||||||0.011
72604513|NCT00765817|144737266|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||||||<0.001
72604514|NCT00765817|144737267|SUPERIORITY_OR_OTHER|||||||0.666||95.0|||||Negative binomial regression model|||||||0.666
72604515|NCT00765817|144737268|SUPERIORITY_OR_OTHER|||||||0.486||95.0|||||Fisher Exact|||||||0.486
72604516|NCT01043133|144737274|SUPERIORITY_OR_OTHER||log-binomial|3.97|STANDARD_ERROR_OF_MEAN|3.97||0.01|TWO_SIDED|95.0|1.34|11.79|||log-binomial regression||Robust Huber-White standard errors account for clustering|||11.79|1.34|.01
72604517|NCT01043133|144737275|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.25|STANDARD_DEVIATION|2.78||0.05|TWO_SIDED|95.0|-2.48|-0.03|||ANCOVA|||||-.03|-2.48|.05
72604518|NCT00255164|144737288|SUPERIORITY_OR_OTHER||||||<|1e-05||||||Hochberg's method was used to ensure that the overall 0.0025 level of significance was maintained for the pairwise comparisons between each dexlansoprazole MR dose and placebo.|Fisher Exact|||||||<0.00001
72604519|NCT00255164|144737288|SUPERIORITY_OR_OTHER||||||<|1e-05||||||Hochberg's method was used to ensure that the overall 0.0025 level of significance was maintained for the pairwise comparisons between each dexlansoprazole MR dose and placebo.|Fisher Exact|||||||<0.00001
72604520|NCT00255164|144737288|SUPERIORITY_OR_OTHER|||||||0.80473||95.0||||Statistical significance was determined at 0.0025 level without adjustment for multiple comparisons.|Fisher Exact|||||||0.80473
72604521|NCT00255164|144737289|SUPERIORITY_OR_OTHER||||||<|1e-05||95.0||||The 0.0025 level of significance for this secondary endpoint was controlled using Hochberg's method for comparisons of each dexlansoprazole MR dose to placebo.|Wilcoxon (Mann-Whitney)|||||||<0.00001
72604522|NCT00255164|144737289|SUPERIORITY_OR_OTHER||||||<|1e-05||95.0||||The 0.0025 level of significance for this secondary endpoint was controlled using Hochberg's method for comparisons of each dexlansoprazole MR dose to placebo.|Wilcoxon (Mann-Whitney)|||||||<0.00001
72604523|NCT00255164|144737289|SUPERIORITY_OR_OTHER|||||||0.76046||95.0||||Statistical significance was determined at 0.0025 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.76046
72604524|NCT00255164|144737291|SUPERIORITY_OR_OTHER||||||<|1e-05||95.0||||Hochberg's method was used to ensure that the overall 0.0025 level of significance was maintained for the pairwise comparisons between each dexlansoprazole MR dose and placebo.|Log Rank|||||||<0.00001
72604525|NCT00255164|144737291|SUPERIORITY_OR_OTHER||||||<|1e-05||95.0||||Hochberg's method was used to ensure that the overall 0.0025 level of significance was maintained for the pairwise comparisons between each dexlansoprazole MR dose and placebo.|Log Rank|||||||<0.00001
72604526|NCT00255164|144737291|SUPERIORITY_OR_OTHER|||||||0.37161||95.0||||Statistical significance was determined at 0.0025 level without adjustment for multiple comparisons.|Log Rank|||||||0.37161
72604527|NCT00255164|144737292|SUPERIORITY_OR_OTHER||||||<|1e-05||95.0||||The 0.0025 level of significance for this secondary endpoint was controlled using Hochberg's method for comparisons of each dose to placebo.|Wilcoxon (Mann-Whitney)|||||||<0.00001
72604528|NCT00255164|144737292|SUPERIORITY_OR_OTHER||||||<|1e-05||95.0||||The 0.0025 level of significance for this secondary endpoint was controlled using Hochberg's method for comparisons of each dose to placebo.|Wilcoxon (Mann-Whitney)|||||||<0.00001
72604529|NCT00255164|144737292|SUPERIORITY_OR_OTHER|||||||0.597||95.0||||Statistical significance was determined at the 0.0025 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.59700
72604530|NCT04776928|144737301|SUPERIORITY|||||||0.01|||||||Two-part regression model|||||||0.010
72604531|NCT00103285|144737304|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|5.17|||||TWO_SIDED|95.0|1.61|16.63|||Mixed Models Analysis||Odds Ratios in this Statistical Analysis corresponds to all four time points.|Physical Functioning: Parents of 160 SR-ALL patients enrolled on Children's Oncology Group (COG) therapeutic trial AALL0331 at 31 sites completed the Pediatric Quality of Life Inventory (PedsQL) 4.0 Generic Core Scales (physical, emotional and social functioning) and Family Assessment Device-General Functioning (FAD-GF) at 1, 6 and 12 months after diagnosis, and 3 months post-therapy.||16.63|1.61|
72604532|NCT00103285|144737304|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.99|||||TWO_SIDED|95.0|1.21|3.27|||Mixed Models Analysis||Odds Ratios in this Statistical Analysis corresponds to all four time points|Social Functioning: Parents of 160 SR-ALL patients enrolled on Children's Oncology Group (COG) therapeutic trial AALL0331 at 31 sites completed the Pediatric Quality of Life Inventory (PedsQL) 4.0 Generic Core Scales (physical, emotional and social functioning) and Family Assessment Device-General Functioning (FAD-GF) at 1, 6 and 12 months after diagnosis, and 3 months post-therapy.||3.27|1.21|
72604533|NCT00103285|144737304|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.85|||||TWO_SIDED|95.0|1.03|3.34|||Mixed Models Analysis||Odds Ratios in this Statistical Analysis corresponds to all four time points|Parents of 160 SR-ALL patients enrolled on Children's Oncology Group (COG) therapeutic trial AALL0331 at 31 sites completed the Pediatric Quality of Life Inventory (PedsQL) 4.0 Generic Core Scales (physical, emotional and social functioning) and Family Assessment Device-General Functioning (FAD-GF) at 1, 6 and 12 months after diagnosis, and 3 months post-therapy.||3.34|1.03|
72604534|NCT00103285|144737305|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|2.542|||||TWO_SIDED|95.0|1.974|3.273|||Regression, Cox|||4981 eligible evaluable patients enrolled on AALL0331 had MRD evaluation at Day 29 of induction. MRD status defined as negative (\<0.1%) or positive (\>=0.1%). MRD status ( positive vs. negative) was correlated with EFS using Cox regression analysis.||3.273|1.974|
72604535|NCT00103285|144737307|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.131|||||TWO_SIDED|95.0|0.101|0.17|||Chi-squared|||MRD status ( positive vs. negative) was correlated with Early Marrow Status (M1 vs M2/M3) using Chi Square test.||0.17|0.101|
72604536|NCT00103285|144737308|OTHER||Odds Ratio (OR)|4.1|||||TWO_SIDED|95.0|1.31|12.73|||Regression, Logistic|||Parents of 159 SR-ALL patients enrolled on Children's Oncology Group (COG) therapeutic trial AALL0331 at 31 sites completed the BASC-2 Anxiety Scale at 1 month after diagnosis, and 3 months post-therapy. Of these 159 had data at 1 month after diagnosis and 96 at 3 months post therapy.||12.73|1.31|
72604537|NCT00913081|144737311|SUPERIORITY_OR_OTHER|||||||0.5|TWO_SIDED||||||Mixed Models Analysis|||The null hypothesis is that quercetin, at any dose, does not attenuate niacin-induced increases in dermal blood flow. Because quercetin has not been used to inhibit flushing from niacin in humans, sample size could not be determined statistically. A sample size of 8 men and 8 women was expected to allow separate estimates of effect size, variability, and shape of distribution for men and women.||||0.5
72604538|NCT00913081|144737311|SUPERIORITY_OR_OTHER|||||||0.8|TWO_SIDED||||||Mixed Models Analysis|||The null hypothesis is that quercetin, at any dose, does not attenuate niacin-induced increases in dermal blood flow.||||0.8
72604539|NCT00913081|144737311|SUPERIORITY_OR_OTHER|||||||0.5|TWO_SIDED||||||Mixed Models Analysis|||The null hypothesis is that quercetin, at any dose, does not attenuate niacin-induced increases in dermal blood flow.||||0.5
72604540|NCT03782987|144737366|OTHER||Geometric mean (gMean) ratio (%) (T/ R)|649.48|STANDARD_ERROR_OF_MEAN|27.7|||TWO_SIDED|90.0|541.29|779.29|||||Confidence intervals were calculated based on the residual error from the ANOVA. Standard error of the mean is actually intra-individual geometric coefficient of variance (gCV).|Statistical model was an analysis of variance (ANOVA) on the logarithmic scale including 'subjects' as random effect and 'treatment' as fixed effect.||779.29|541.29|
72604541|NCT03782987|144737367|OTHER||gMean ratio (%) (T/ R)|166.88|STANDARD_ERROR_OF_MEAN|17.7|||TWO_SIDED|90.0|148.42|187.64|||||Confidence intervals were calculated based on the residual error from the ANOVA. Standard error of the mean is actually intra-individual geometric coefficient of variance (gCV).|Statistical model was an analysis of variance (ANOVA) on the logarithmic scale including 'subjects' as random effect and 'treatment' as fixed effect.||187.64|148.42|
72604542|NCT03782987|144737368|OTHER||gMean ratio (%) (T/ R)|931.41|STANDARD_ERROR_OF_MEAN|25.9|||TWO_SIDED|90.0|785.19|1104.85|||||Confidence intervals were calculated based on the residual error from the ANOVA. Standard error of the mean is actually intra-individual geometric coefficient of variance (gCV).|Statistical model was an analysis of variance (ANOVA) on the logarithmic scale including 'subjects' as random effect and 'treatment' as fixed effect.||1104.85|785.19|
72604543|NCT01877668|144737369|SUPERIORITY_OR_OTHER||Risk Difference (RD)|17.13|STANDARD_ERROR_OF_MEAN|6.67||0.0102|TWO_SIDED|95.0|4.06|30.21|||Large sample approximation|Missing response (MR)=non-response (NR)||||30.21|4.06|0.0102
72604544|NCT01877668|144737369|SUPERIORITY_OR_OTHER||Risk Difference (RD)|27.24|STANDARD_ERROR_OF_MEAN|6.64|<|0.0001|TWO_SIDED|95.0|14.22|40.26|||Large sample approximation|MR=NR||||40.26|14.22|<0.0001
72604545|NCT01877668|144737369|SUPERIORITY_OR_OTHER||Risk Difference (RD)|18.55|STANDARD_ERROR_OF_MEAN|6.69||0.0055|TWO_SIDED|95.0|5.45|31.66|||Large sample approximation|MR=NR||||31.66|5.45|0.0055
72604546|NCT01877668|144737370|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1697|STANDARD_ERROR_OF_MEAN|0.06173||0.0062|TWO_SIDED|95.0|-0.291|-0.0483|||Mixed Models Analysis|No imputation.||||-0.0483|-0.2910|0.0062
72604547|NCT01877668|144737370|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.2196|STANDARD_ERROR_OF_MEAN|0.06184||0.0004|TWO_SIDED|95.0|-0.3411|-0.098|||Mixed Models Analysis|No imputation.||||-0.0980|-0.3411|0.0004
72604548|NCT01877668|144737370|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.2005|STANDARD_ERROR_OF_MEAN|0.06145||0.0012|TWO_SIDED|95.0|-0.3213|-0.0797|||Mixed Models Analysis|No imputation.||||-0.0797|-0.3213|0.0012
72604549|NCT01111565|144737415|SUPERIORITY||Treatment Difference|-5.4|||=|0.079|TWO_SIDED|95.0|-11.5|0.7|||ANCOVA|||||0.7|-11.5|=0.079
72604550|NCT01111565|144737415|SUPERIORITY||Treatment Difference|-5.2|||=|0.085|TWO_SIDED|95.0|-11.2|0.7|||ANCOVA|||||0.7|-11.2|=0.085
72604551|NCT01111565|144737416|SUPERIORITY||Treatment Difference|-0.5|||=|0.148|TWO_SIDED|95.0|-1.1|0.1|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel Row Mean Scores Test was used to determine the p-value.||||0.1|-1.1|=0.148
72604552|NCT01111565|144737416|SUPERIORITY||Treatment Difference|-0.4|||=|0.242|TWO_SIDED|95.0|-1.0|0.3|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel Row Mean Scores Test was used to determine the p-value.||||0.3|-1.0|=0.242
72604553|NCT01111565|144737417|SUPERIORITY||Treatment Difference|0.1|||=|0.91|TWO_SIDED|95.0|-1.8|2.1|||ANCOVA|||||2.1|-1.8|=0.910
72604554|NCT01111565|144737417|SUPERIORITY||Treatment Difference|-1.0|||=|0.291|TWO_SIDED|95.0|-3.0|0.9|||ANCOVA|||||0.9|-3.0|=0.291
72416255|NCT01972841|144343307|SUPERIORITY||Least squares mean difference|-0.23|STANDARD_ERROR_OF_MEAN|0.11||0.043|TWO_SIDED|95.0|-0.45|-0.02|||Stratified rank ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (solifenacin 5 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||-0.02|-0.45|0.043
72604555|NCT02258217|144737427|EQUIVALENCE|"We created a difference in ADL score variable. This was calculated as follows:~ADL score (new relapse) - ADL score (after treatment of current relapse)~This difference score was tested for equivalence to 0 or not."|Mean Difference (Final Values)|-1.8|STANDARD_DEVIATION|3.03||0.003|TWO_SIDED|95.0|-2.9|-0.66|||Paired t-test, 2 sided|||"We compared the two ADL scores measured in the same arm at different timepoints (new \& after treatment).~Null Hypothesis = Difference in means is = 0 Alternate Hypothesis = Difference in means is not = 0~We used the Paired t-test to compare the pre - post ADL scores."||-0.66|-2.9|0.003
72604556|NCT02258217|144737428|EQUIVALENCE|"We created a difference in ADL score variable. This was calculated as follows:~ADL score (new relapse) - ADL score (after treatment of current relapse) This difference score was tested for equivalence to 0 or not."|Mean Difference (Final Values)|0.0|STANDARD_DEVIATION|3.09||0.99|TWO_SIDED|95.0|-1.22|1.22|||Paired t-test, 2 sided|||"We compared the two RSH scores measured in the same arm at different time points (new \& after treatment).~Null Hypothesis = Difference in means is = 0 Alternate Hypothesis = Difference in means is not = 0 We used the Paired t-test to compare the pre - post RSH scores."||1.22|-1.22|0.99
72604557|NCT02258217|144737430|EQUIVALENCE|"We created a difference in PCS score variable. This was calculated as follows:~PCS score (new relapse) - PCS score (after treatment of current relapse). This difference score was tested for equivalence to 0 or not."|Mean Difference (Final Values)|-1.9|STANDARD_DEVIATION|4.42||0.03|TWO_SIDED|95.0|-3.67|-0.18|||Paired t-test, two sided|||"We compared the two PCS scores measured in the same arm at different timepoints (new \& after treatment).~Null Hypothesis = Difference in means is = 0 Alternate Hypothesis = Difference in means is not = 0 We used the Paired t-test to compare the pre - post PCS scores."||-0.18|-3.67|0.03
72604558|NCT02258217|144737431|EQUIVALENCE|"We created a difference in MSIS physical score variable. This was calculated as follows:~MSIS physical score (new relapse) - MSIS physical score (after treatment of current relapse)~This difference score was tested for equivalence to 0 or not."|Median Difference (Final Values)|2.5||||0.19|TWO_SIDED||||||Wilcoxon Signed Rank test|||"We compared the two MSIS physical scores measured in the same arm at different timepoints (new relapse \& after treatment of relapse).~Null Hypothesis = Difference in medians is = 0 Alternate Hypothesis = Difference in medians is not = 0~We used the Wilcoxon Signed rank test to compare the pre - post MSIS physical scores."||||0.19
72604559|NCT02258217|144737432|EQUIVALENCE|"We created a difference in MSIS psychological score variable. This was calculated as follows:~MSIS psychological score (new relapse) - MSIS psychological score (after treatment of current relapse)~This difference score was tested for equivalence to 0 or not."|Mean Difference (Final Values)|3.1|STANDARD_DEVIATION|6.3||0.01|TWO_SIDED|95.0|0.74|5.45|||Paired t-test, 2 sided|||"We compared the two MSIS psychological scores measured in the same arm at different timepoints (new relapse \& after treatment of relapse).~Null Hypothesis = Difference in means is = 0 Alternate Hypothesis = Difference in means is not = 0~We used the Paired t-test to compare the pre - post MSIS psychological scores."||5.45|0.74|0.01
72604560|NCT02258217|144737433|EQUIVALENCE|"We created a difference in EDSS score variable. This was calculated as follows:~EDSS score (new relapse) - EDSS score (after treatment of current relapse)~This difference score was tested for equivalence to 0 or not."|Median Difference (Final Values)|0.0||||0.23|TWO_SIDED||||||Wilcoxon Signed Rank test||The interquartile range for the median difference in EDSS scores is 0.0 to 0.5|"We compared the two EDSS scores measured in the same arm at different timepoints (new relapse \& after treatment of relapse).~Null Hypothesis = Difference in medians is = 0 Alternate Hypothesis = Difference in medians is not = 0~We used the Wilcoxon Signed rank test to compare the pre - post EDSS scores."||||0.23
72604561|NCT02258217|144737434|EQUIVALENCE|"We created a difference in SAGE score variable. This was calculated as follows:~SAGE score (new relapse) - SAGE score (after treatment of current relapse)~This difference score was tested for equivalence to 0 or not."|Median Difference (Final Values)|0.0||||0.44|TWO_SIDED||||||Wilcoxon Signed Rank test||The interquartile range for the difference in medians is -1 to 0.|"We compared the two SAGE scores measured in the same arm at different time points (new relapse \& after treatment of relapse).~Null Hypothesis = Difference in medians is = 0 Alternate Hypothesis = Difference in medians is not = 0~We used the Wilcoxon Signed rank test to compare the pre - post SAGE scores."||||0.44
72604562|NCT00447772|144737450|SUPERIORITY_OR_OTHER_LEGACY||Mean difference|-0.322|||=|0.2552|TWO_SIDED|95.0|-0.877|0.233|||ANCOVA||The comparative analysis is based on adjusted means data.|An analysis of covariance (ANCOVA) model included the baseline total Tsui score (patient in sitting position) as covariate and the main type of CD as between-group factor (due to non-significance the interaction between baseline total Tsui score and the main type of CD was removed from the model).||0.233|-0.877|=0.2552
72604563|NCT00875563|144737471|NON_INFERIORITY_OR_EQUIVALENCE|An exact test method (Sidik K. 2003, Statistics in Medicine 22: 265-278) for matched controls was used, at a type I error rate of 0.05 and a non-inferiority margin of 10%. 38 pairs of patients were determined necessary, and the power was calculated to be 0.92.||||||0.02|TWO_SIDED||||||Exact test for matched pairs|||Patients treated with the Zenith® Fenestrated AAA Endovascular Graft were compared with matched patients treated with the Zenith® AAA Endovascular Graft.||||0.02
72604564|NCT01305811|144737501|SUPERIORITY_OR_OTHER|||||||0.03|TWO_SIDED||||||general estimating equations|||||||0.03
72604565|NCT01305811|144737502|SUPERIORITY_OR_OTHER||||||=|0.22|TWO_SIDED||||||t-test, 2 sided|||In our original proposal to the funder, to protect our main outcome from possibly large attrition, we proposed to initially test mean differences between groups following 2 months of treatment or wait list using Student's t-tests at an alpha=0.05.||||=0.22
72604566|NCT02849743|144737507|OTHER||Least Means Square|-0.5||||0.92|TWO_SIDED||||||Regression, Linear|||||||0.92
72604567|NCT02849743|144737508|OTHER||Regression Coefficient|-15784.0||||0.57|TWO_SIDED||||||Regression, Linear|||||||0.57
72604568|NCT02849743|144737509|OTHER||Regression Coefficient|48.0||||0.21|TWO_SIDED||||||Mixed Models Analysis|||||||0.21
72604569|NCT02849743|144737510|OTHER||Regression Coefficient|-2.8||||0.55|TWO_SIDED||||||Regression, Linear|||||||0.55
72604570|NCT02849743|144737511|OTHER||Regression Coefficient|1.2||||0.86|TWO_SIDED||||||Regression, Linear|||||||0.86
72604571|NCT02849743|144737512|OTHER||Regression Coefficient|2.4||||0.88|TWO_SIDED||||||Regression, Linear|||||||0.88
72604572|NCT02849743|144737513|OTHER||Regression Coefficient|-0.02||||0.5|TWO_SIDED||||||Regression, Linear|||||||0.50
72604573|NCT02849743|144737514|OTHER||Regression Coefficient|-0.02||||0.49|TWO_SIDED||||||Regression, Linear|||||||0.49
72604574|NCT02849743|144737516|OTHER||Regression Coefficient|-0.7||||0.68|TWO_SIDED||||||Regression, Linear|||||||0.68
72604575|NCT02849743|144737517|OTHER||Regression Coefficient|-0.6||||0.52|TWO_SIDED||||||Regression, Linear|||||||0.52
72604576|NCT02849743|144737518|OTHER||Regression Coefficient|-0.2||||0.91|TWO_SIDED||||||Regression, Linear|||Neuro-QoL - Anxiety||||0.91
72604577|NCT02849743|144737518|OTHER||Regression Coefficient|-0.2||||0.91|TWO_SIDED||||||Regression, Linear|||Neuro-QoL - Depression||||0.91
72604578|NCT02849743|144737518|OTHER||Regression Coefficient|4.7||||0.04|TWO_SIDED||||||Regression, Linear|||Neuro-QoL - Cognition||||0.04
72604579|NCT02849743|144737518|OTHER||Regression Coefficient|2.3||||0.36|TWO_SIDED||||||Regression, Linear|||Neuro-QoL - Social Function||||0.36
72604580|NCT02849743|144737519|OTHER||Regression Coefficient|0.05||||0.64|TWO_SIDED||||||Regression, Linear|||||||0.64
72604581|NCT02849743|144737520|OTHER||Regression Coefficient|0.05||||0.83|TWO_SIDED||||||Regression, Linear|||||||0.83
72604582|NCT03064113|144737523|SUPERIORITY||Difference of LS Mean|173.8|||<|0.001|TWO_SIDED|95.0|112.4|235.3|||t-test, 2 sided|||||235.3|112.4|<0.001
72604583|NCT03064113|144737523|SUPERIORITY||Difference of LS Mean|169.3|||<|0.001|TWO_SIDED|95.0|107.8|230.8|||t-test, 2 sided|||||230.8|107.8|<0.001
72604584|NCT03064113|144737523|SUPERIORITY||Difference of LS Mean|175.6|||<|0.001|TWO_SIDED|95.0|114.1|237.2|||t-test, 2 sided|||||237.2|114.1|<0.001
72604585|NCT03064113|144737524|SUPERIORITY||Slope|112.5||||0.001|TWO_SIDED|95.0|44.5|180.5|||t-test, 2 sided|||Tx Difference of LS Mean FEV1 at 12 hr||180.5|44.5|0.001
72604586|NCT03064113|144737524|SUPERIORITY||Difference of LS Mean|123.4|||<|0.001|TWO_SIDED|95.0|54.6|192.3|||t-test, 2 sided|||Tx Difference of LS Mean FEV1 at 12 hr||192.3|54.6|<0.001
72604587|NCT03064113|144737524|SUPERIORITY||Difference of LS Mean|15.3||||0.659|TWO_SIDED|95.0|-53.5|94.1|||t-test, 2 sided|||Tx Difference of LS Mean FEV1 at 12 hr||94.1|-53.5|0.659
72604588|NCT03064113|144737524|SUPERIORITY||Difference of LS Mean|102.8|||<|0.001|TWO_SIDED|95.0|54.1|151.5|||t-test, 2 sided|||Tx Difference of LS Mean FEV1 at 24 hr||151.5|54.1|<0.001
72604589|NCT03064113|144737524|SUPERIORITY||Difference of LS Mean|136.6|||<|0.001|TWO_SIDED|95.0|87.8|185.3|||t-test, 2 sided|||Tx Difference of LS Mean FEV1 at 24 hr||185.3|87.8|<0.001
72604590|NCT03064113|144737524|SUPERIORITY|Tx Difference of LS Mean FEV1 at 24 hr|Difference of LS Mean|-24.2||||0.327|TWO_SIDED|95.0|-72.9|24.6|||t-test, 2 sided|||||24.6|-72.9|0.327
72604591|NCT03064113|144737525|SUPERIORITY||Difference of LS Mean|26.4|||<|0.001|TWO_SIDED|95.0|18.0|34.8|||t-test, 2 sided|||Tx Difference of LS Mean AUC, 0-12 hrs||34.8|18.0|<0.001
72604592|NCT03064113|144737525|SUPERIORITY||Difference of LS Mean|29.1|||<|0.001|TWO_SIDED|95.0|20.8|37.4|||t-test, 2 sided|||Tx Difference of LS Mean AUC, 0-12 hrs||37.4|20.8|<0.001
72604593|NCT03064113|144737525|SUPERIORITY||Difference of LS Mean|25.6|||<|0.001|TWO_SIDED|95.0|17.3|33.9|||t-test, 2 sided|||Tx Difference of LS Mean AUC, 0-12 hrs||33.9|17.3|<0.001
72604594|NCT03064113|144737525|SUPERIORITY||Difference of LS Mean|20.1|||<|0.001|TWO_SIDED|95.0|12.1|28.2|||t-test, 2 sided|||Tx Difference of LS Mean AUC, 0-24 hrs||28.2|12.1|<0.001
72604595|NCT03064113|144737525|SUPERIORITY||Difference of LS Mean|25.4|||<|0.001|TWO_SIDED|95.0|17.4|33.4|||t-test, 2 sided|||Tx Difference of LS Mean AUC, 0-24 hrs||33.4|17.4|<0.001
72604596|NCT03064113|144737525|SUPERIORITY||Difference of LS Mean|10.6||||0.01|TWO_SIDED|95.0|2.5|18.6|||t-test, 2 sided|||Tx Difference of LS Mean AUC, 0-24 hr||18.6|2.5|0.010
72604597|NCT03064113|144737526|SUPERIORITY||Difference of LS Mean|0.1||||0.003|TWO_SIDED|95.0|0.0|0.2|||t-test, 2 sided|||Tx Difference of LS Mean 12 hr||0.2|0.0|0.003
72604598|NCT03064113|144737526|SUPERIORITY||Difference of LS Mean|0.1||||0.046|TWO_SIDED|95.0|0.0|0.2|||t-test, 2 sided|||Tx Difference of LS Mean 12 hr||0.2|0.0|0.046
72604599|NCT03064113|144737526|SUPERIORITY||Difference of LS Mean|0.1||||0.003|TWO_SIDED|95.0|0.0|0.2|||t-test, 2 sided|||Tx Difference of LS Mean 12 hr||0.2|0.0|0.003
72604600|NCT03064113|144737526|SUPERIORITY||Difference of LS Mean|0.1||||0.003|TWO_SIDED|95.0|0.0|0.2|||t-test, 2 sided|||Tx Difference of LS Mean 24 hr||0.2|0.0|0.003
72604601|NCT03064113|144737526|SUPERIORITY||Difference of LS Mean|0.1||||0.048|TWO_SIDED|95.0|0.0|0.2|||t-test, 2 sided|||Tx Difference of LS Mean 24 hr||0.2|0.0|0.048
72604602|NCT03064113|144737526|SUPERIORITY||Difference of LS Mean|0.1||||0.007|TWO_SIDED|95.0|0.0|0.2|||t-test, 2 sided|||Tx Difference of LS Mean 24 hr||0.2|0.0|0.007
72604603|NCT03064113|144737527|SUPERIORITY||Difference of LS Mean|0.1||||0.054|TWO_SIDED|95.0|0.0|0.1|||t-test, 2 sided|||Tx Difference of LS Mean 12 hr||0.1|-0.0|0.054
72604604|NCT03064113|144737527|SUPERIORITY||Difference of LS Mean|0.1||||0.045|TWO_SIDED|95.0|0.0|0.2|||t-test, 2 sided|||Tx Difference of LS Mean 12 hr||0.2|0.0|0.045
72604605|NCT03064113|144737527|SUPERIORITY||Difference of LS Mean|0.0||||0.503|TWO_SIDED|95.0|0.0|0.1|||t-test, 2 sided|||Tx Difference of LS Mean 12 hr||0.1|-0.0|0.503
72604606|NCT03064113|144737527|SUPERIORITY||Difference of LS Mean|0.0||||0.183|TWO_SIDED|95.0|0.0|0.1|||t-test, 2 sided|||Tx Difference of LS Mean 24 hr||0.1|-0.0|0.183
72604607|NCT03064113|144737527|SUPERIORITY||Difference of LS Mean|0.0||||0.422|TWO_SIDED|95.0|0.0|0.1|||t-test, 2 sided|||Tx Difference of LS Mean 24 hr||0.1|-0.0|0.422
72604608|NCT03064113|144737527|SUPERIORITY||Difference of LS Mean|0.0||||0.287|TWO_SIDED|95.0|-0.1|0.0|||t-test, 2 sided|||Tx Difference of LS Mean 24 hr||0.0|-0.1|0.287
72604609|NCT03064113|144737529|SUPERIORITY||Difference of LS Mean|3975.5|||<|0.001|TWO_SIDED|95.0|2007.3|5943.7|||t-test, 2 sided|||||5943.7|2007.3|<0.001
72604610|NCT03064113|144737529|SUPERIORITY||Difference of LS Mean|5888.9|||<|0.001|TWO_SIDED|95.0|3924.4|7853.4|||t-test, 2 sided|||||7853.4|3924.4|<0.001
72604611|NCT03064113|144737529|SUPERIORITY||Difference of LS Mean|2654.7||||0.009|TWO_SIDED|95.0|689.7|4619.6|||t-test, 2 sided|||||4619.6|689.7|0.009
72604612|NCT04607135|144737544|OTHER|||||||0.0003||||||F-statistic = 11.71|Welch's ANOVA|||||||0.0003
72604613|NCT04607135|144737544|OTHER|||||||0.002||||||q-statistic = 6.74|Games-Howell post-hoc test|||||||0.002
72604614|NCT04607135|144737544|OTHER|||||||0.24||||||q-statistic = 2.34|Games-Howell post-hoc test|||||||0.24
72604615|NCT04607135|144737544|OTHER|||||||0.35||||||q-statistic = 2.04|Games-Howell post-hoc test|||||||0.35
72604616|NCT04607135|144737545|OTHER|||||||0.99|||||||Kruskal-Wallis|||||||0.99
72604617|NCT04607135|144737546|OTHER|||||||0.74|||||||Kruskal-Wallis|||||||0.74
72604618|NCT03990051|144737559|SUPERIORITY|Comparison of changes in score from baseline, Active - Placebo.||||||0.0197|||||||Mixed Models Analysis|||||||0.0197
72604619|NCT03990051|144737560|SUPERIORITY|Comparison of changes in score from baseline.||||||0.0039|||||||Mixed Models Analysis|||||||0.0039
72604620|NCT03990051|144737561|SUPERIORITY|Comparison of changes in score from baseline.|||||<|0.0001|||||||Mixed Models Analysis|||||||<0.0001
72604621|NCT03990051|144737562|SUPERIORITY|Comparison of changes in score from baseline.||||||0.0002|||||||ANCOVA|||||||0.0002
72604622|NCT03990051|144737563|SUPERIORITY|Comparison of changes in score from baseline.||||||0.0138|||||||Mixed Models Analysis|||||||0.0138
72604623|NCT03990051|144737564|SUPERIORITY|Comparison of changes in score from baseline.||||||0.0014|||||||Mixed Models Analysis|||||||0.0014
72604624|NCT03990051|144737565|SUPERIORITY|Comparison of changes in score from baseline.||||||0.0849|||||||Mixed Models Analysis|||||||0.0849
72604625|NCT03990051|144737566|SUPERIORITY|Comparison of changes in score from baseline.||||||0.0041|||||||Mixed Models Analysis|||||||0.0041
72604626|NCT03990051|144737567|SUPERIORITY|Comparison of changes in score from baseline.||||||0.0006|||||||Mixed Models Analysis|||||||0.0006
72604627|NCT03990051|144737568|SUPERIORITY|Comparison of changes in score from baseline.||||||0.0143|||||||Mixed Models Analysis|||||||0.0143
72604628|NCT03990051|144737569|SUPERIORITY|Comparison of changes in score from baseline.||||||0.0398|||||||Mixed Models Analysis|||||||0.0398
72604629|NCT03990051|144737570|SUPERIORITY|Comparison of changes in score from baseline.||||||-3.97|||||||Mixed Models Analysis|||||||-3.97
72604630|NCT03990051|144737571|SUPERIORITY|Comparison of changes in score from baseline.||||||0.0005|||||||Mixed Models Analysis|||||||0.0005
72604631|NCT03990051|144737572|SUPERIORITY|Comparison of changes in score from baseline.||||||0.0005|||||||Mixed Models Analysis|||||||0.0005
72604632|NCT03990051|144737573|SUPERIORITY|Comparison of changes in score from baseline.||||||0.0067|||||||Mixed Models Analysis|||||||0.0067
72604633|NCT03990051|144737574|SUPERIORITY|Comparison of changes in score from baseline.||||||0.0636|||||||Mixed Models Analysis|||||||0.0636
72604634|NCT03990051|144737575|SUPERIORITY|Comparison of changes in score from baseline.||||||0.0028|||||||Mixed Models Analysis|||||||0.0028
72604635|NCT03990051|144737576|SUPERIORITY|Comparison of changes in score from baseline.||||||0.0067|||||||Mixed Models Analysis|||||||0.0067
72604636|NCT03990051|144737577|SUPERIORITY|Comparison of changes in score from baseline.||||||0.0105|||||||Mixed Models Analysis|||||||0.0105
72604637|NCT03990051|144737578|SUPERIORITY|Comparison of changes in score from baseline.||||||0.001|||||||Mixed Models Analysis|||||||0.0010
72604638|NCT03990051|144737579|SUPERIORITY|Comparison of changes in score from baseline.||||||0.0155|||||||Mixed Models Analysis|||||||0.0155
72604639|NCT03990051|144737580|SUPERIORITY|Comparison of changes in score from baseline.||||||0.016|||||||Mixed Models Analysis|||||||0.0160
72604640|NCT03990051|144737581|SUPERIORITY|Comparison of changes in score from baseline.||||||0.0117|||||||Mixed Models Analysis|||||||0.0117
72604641|NCT03990051|144737582|SUPERIORITY|Comparison of changes in score from baseline.||||||0.4649|||||||Mixed Models Analysis|||||||0.4649
72604642|NCT03990051|144737583|SUPERIORITY|Comparison of changes in score from baseline.||||||0.0082|||||||Mixed Models Analysis|||||||0.0082
72604643|NCT03990051|144737584|SUPERIORITY|Comparison of changes in score from baseline.||||||0.0225|||||||Mixed Models Analysis|||||||0.0225
72604644|NCT03990051|144737585|SUPERIORITY|Comparison of changes in score from baseline.||||||0.1822|||||||Mixed Models Analysis|||||||0.1822
72604645|NCT03990051|144737586|SUPERIORITY|Comparison of changes in score from baseline.||||||0.0515|||||||Mixed Models Analysis|||||||0.0515
72604646|NCT03990051|144737587|SUPERIORITY|Comparison of changes in score from baseline.||||||0.044|||||||Mixed Models Analysis|||||||0.044
72604647|NCT03990051|144737588|SUPERIORITY|Comparison of changes of score from baseline.||||||0.083|||||||Mixed Models Analysis|||||||0.083
72604648|NCT03990051|144737589|SUPERIORITY|Comparison of changes in score from baseline.||||||0.7147|||||||Mixed Models Analysis|||||||0.7147
72604649|NCT03990051|144737590|SUPERIORITY|Comparison of changes in score from baseline.||||||0.8251|||||||Mixed Models Analysis|||||||0.8251
72604650|NCT03990051|144737591|SUPERIORITY|Comparison of changes in score from baseline.||||||0.0435|||||||Mixed Models Analysis|||||||0.0435
72604651|NCT03990051|144737592|SUPERIORITY|Comparison of changes in score from baseline.||||||0.013|||||||Mixed Models Analysis|||||||0.0130
72604652|NCT03990051|144737593|SUPERIORITY|Comparison of changes in score from baseline.||||||0.3205|||||||Mixed Models Analysis|||||||0.3205
72604653|NCT03990051|144737594|SUPERIORITY|Comparison of changes in score from baseline.||||||0.1401|||||||Mixed Models Analysis|||||||0.1401
72604654|NCT03990051|144737595|SUPERIORITY|Comparison in changes in score from baseline.||||||0.0098|||||||ANCOVA|||||||0.0098
72604655|NCT03990051|144737596|SUPERIORITY|Comparison of changes in score from baseline.||||||0.1032|||||||Mixed Models Analysis|||||||0.1032
72604656|NCT03990051|144737597|SUPERIORITY|Comparison of changes in score from baseline.||||||0.0389|||||||Mixed Models Analysis|||||||0.0389
72604657|NCT03990051|144737598|OTHER||||||<|1e-05|||||||t-test, 2 sided|||Score in 1 year compared to baseline||||<0.00001
72604658|NCT03990051|144737599|OTHER||||||<|1e-05|||||||t-test, 2 sided|||||||<0.00001
72604659|NCT03990051|144737600|OTHER||||||<|1e-05|||||||t-test, 2 sided|||||||<0.00001
72604660|NCT03990051|144737601|OTHER||||||<|1e-05|||||||t-test, 2 sided|||||||<0.00001
72604661|NCT03990051|144737602|OTHER|||||||0.0002|||||||t-test, 2 sided|||||||0.0002
72604662|NCT03990051|144737603|OTHER|||||||0.0001|||||||t-test, 2 sided|||||||0.0001
72604663|NCT03990051|144737604|OTHER||||||<|1e-05|||||||t-test, 2 sided|||||||<0.00001
72604664|NCT03990051|144737605|OTHER||||||<|1e-05|||||||t-test, 2 sided|||||||<0.00001
72604665|NCT03990051|144737606|SUPERIORITY||||||<|1e-05|||||||t-test, 2 sided|||||||<0.00001
72604666|NCT03990051|144737607|OTHER||||||<|1e-05|||||||t-test, 2 sided|||||||<0.00001
72604667|NCT03990051|144737608|OTHER||||||<|1e-05|||||||t-test, 2 sided|||||||<0.00001
72604668|NCT03990051|144737609|OTHER||||||<|1e-05|||||||t-test, 2 sided|||||||<0.00001
72604669|NCT03990051|144737610|OTHER|||||||0.0001|||||||t-test, 2 sided|||||||0.0001
72604670|NCT03990051|144737611|OTHER||||||<|1e-05|||||||t-test, 2 sided|||||||<0.00001
72604671|NCT03990051|144737612|OTHER||||||<|1e-05|||||||t-test, 2 sided|||||||<0.00001
72604672|NCT03990051|144737613|OTHER||||||<|1e-05|||||||t-test, 2 sided|||||||<0.00001
72604673|NCT03990051|144737614|OTHER||||||<|1e-05|||||||t-test, 2 sided|||||||<0.00001
72604674|NCT03990051|144737615|OTHER||||||<|1e-05|||||||t-test, 2 sided|||||||<0.00001
72604675|NCT03126786|144737639|SUPERIORITY|The sample size was determined such that the difference in visual acuity between the ACTIVE treatment group and CONTROL treatment group could be estimated within +/- five ETDRS letters. Week 24 data from the Eylea prescribing information was used to estimate a pooled standard deviation of 9.17 letters. With 28 subjects per arm, a two-sided 90% confidence interval with a distance from the mean difference to the limits (half of interval width) will be less than 5 letters.|Mean Difference (Final Values)|-2.4|STANDARD_ERROR_OF_MEAN|2.28||0.288|TWO_SIDED|90.0|-6.2|1.4||There was a single primary outcome tested at a single primary endpoint, therefore no adjustments for multiple comparisons were performed. The primary endpoint was assess with a 2-sided alpha level of 0.100.|Mixed model for repeat measures|The covariance structure was assumed to be unstructured.|Estimated Value calculated as Active minus Control.|The primary efficacy analysis comparing ACTIVE with CONTROL on the mean change from baseline (Visit 2, Day 0) BCVA at Week 12 was be performed using a Mixed Model for Repeated Measurements (MMRM). This model included treatment (ACTIVE or CONTROL), visit (Visit 3 (Week 4), Visit 4 (Week 8), and Visit 5 (Week 12), Visit 6 (Week 16), Visit 7 (Week 20) and Visit 8 (Week 24), and the 2-way interactions of treatment and visit, and the BCVA baseline included as the covariate.||1.4|-6.2|0.288
72604676|NCT00905424|144737641|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.3||||0.0902|TWO_SIDED|90.0|-4.5|-0.1||The test was performed a priori at the significance level of 0.10|ANCOVA|||||-0.1|-4.5|0.0902
72604677|NCT00905424|144737642|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.9||||0.3091|TWO_SIDED|90.0|-2.4|0.6||The test was performed a priori at the significance level of 0.10|ANCOVA|||||0.6|-2.4|0.3091
72604678|NCT00905424|144737643|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.0||||0.0573|TWO_SIDED|90.0|-3.7|-0.3||The test was performed a priori at the significance level of 0.10|ANCOVA|||||-0.3|-3.7|0.0573
72604679|NCT00905424|144737644|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2368||95.0|||||Cochran-Mantel-Haenszel|||||||0.2368
72604680|NCT00905424|144737647|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.0||||0.0463|TWO_SIDED|90.0|-5.4|-0.5||The test was performed a priori at the significance level of 0.10|ANCOVA|||Global Executive Composite||-0.5|-5.4|0.0463
72604681|NCT00905424|144737647|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.0||||0.1431|TWO_SIDED|90.0|-4.3|0.3||The test was performed a priori at the significance level of 0.10|ANCOVA|||Behavioral Regulation Index||0.3|-4.3|0.1431
72604682|NCT00905424|144737647|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.3||||0.0281|TWO_SIDED|90.0|-5.8|-0.8||The test was performed a priori at the significance level of 0.10|ANCOVA|||Metacognition Index||-0.8|-5.8|0.0281
72604683|NCT00905424|144737648|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.0||||0.092|TWO_SIDED|90.0|-6.0|-0.1||The test was performed a priori at the significance level of 0.10|ANCOVA|||||-0.1|-6.0|0.0920
72604684|NCT00905424|144737649|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.2||||0.0774|TWO_SIDED|90.0|-2.2|-0.1||The test was performed a priori at the significance level of 0.10|ANCOVA|||||-0.1|-2.2|0.0774
72604685|NCT00905424|144737650|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.2||||0.4726|TWO_SIDED|90.0|-1.6|4.0||The test was performed a priori at the significance level of 0.10|ANCOVA|||||4.0|-1.6|0.4726
72604686|NCT00905424|144737651|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.9||||0.5182|TWO_SIDED|90.0|-1.4|3.1||The test was performed a priori at the significance level of 0.10|ANCOVA|||||3.1|-1.4|0.5182
72604687|NCT00905424|144737652|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.9||||0.463|TWO_SIDED|90.0|-3.1|1.2||The test was performed a priori at the significance level of 0.10|ANCOVA|||||1.2|-3.1|0.4630
72604688|NCT00905424|144737653|SUPERIORITY_OR_OTHER_LEGACY|||||||0.523||95.0|||||Cochran-Mantel-Haenszel|||||||0.5230
72604689|NCT00905424|144737656|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.8||||0.2876|TWO_SIDED|90.0|-1.0|4.7||The test was performed a priori at the significance level of 0.10|ANCOVA|||Global Executive Composite||4.7|-1.0|0.2876
72604690|NCT00905424|144737656|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.1||||0.559|TWO_SIDED|90.0|-2.1|4.4||The test was performed a priori at the significance level of 0.10|ANCOVA|||Behavioral Regulation Index||4.4|-2.1|0.5590
72604691|NCT00905424|144737656|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.3||||0.2079|TWO_SIDED|90.0|-0.7|5.2||The test was performed a priori at the significance level of 0.10|ANCOVA|||Metacognition Index||5.2|-0.7|0.2079
72604692|NCT00905424|144737657|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.7||||0.1489|TWO_SIDED|90.0|-8.0|0.5||The test was performed a priori at the significance level of 0.10|ANCOVA|||||0.5|-8.0|0.1489
72604693|NCT00905424|144737658|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.4||||0.0852|TWO_SIDED|90.0|-2.8|-0.1||The test was performed a priori at the significance level of 0.10|ANCOVA|||||-0.1|-2.8|0.0852
72604694|NCT00379899|144737677|SUPERIORITY_OR_OTHER|||||||0.073|||||||Cochran-Mantel-Haenszel|Adjusted for screening total coronary artery calcification score stratification factor (≥ 30 to 399, ≥ 400 to 999, and ≥ 1000)||||||0.073
72604695|NCT00379899|144737678|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.62||||0.094||95.0|0.36|1.08|||Cochran-Mantel-Haenszel||Logit estimates (Cinacalcet:Control)|||1.08|0.36|0.094
72604696|NCT00379899|144737679|SUPERIORITY_OR_OTHER|||||||0.018|||||||Cochran-Mantel-Haenszel|Adjusted for screening total coronary artery calcification score stratification factor||||||0.018
72604697|NCT00379899|144737681|SUPERIORITY_OR_OTHER|||||||0.258|||||||Cochran-Mantel-Haenszel|||||||0.258
72604698|NCT00379899|144737682|SUPERIORITY_OR_OTHER|||||||0.011|||||||Cochran-Mantel-Haenszel|Adjusted for screening total coronary artery calcification score stratification factor||||||0.011
72604699|NCT00379899|144737683|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|Adjusted for screening total coronary artery calcification score stratification factor||||||<0.001
72604700|NCT00379899|144737684|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|Adjusted for screening total coronary artery calcification score stratification factor||||||<0.001
72604701|NCT00379899|144737685|SUPERIORITY_OR_OTHER|||||||0.025|||||||Cochran-Mantel-Haenszel|Adjusted for screening total coronary artery calcification score stratification factor||||||0.025
72604702|NCT00379899|144737686|SUPERIORITY_OR_OTHER|||||||0.021|||||||Cochran-Mantel-Haenszel|Adjusted for screening total coronary artery calcification score stratification factor||||||0.021
72604703|NCT00379899|144737687|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|Adjusted for screening total coronary artery calcification score stratification factor||||||<0.001
72604704|NCT00379899|144737688|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|Adjusted for screening total coronary artery calcification score stratification factor||||||<0.001
72604705|NCT03804268|144737702|SUPERIORITY||Percentage Difference|22.5|||<|0.0001|TWO_SIDED|95.0|14.3|30.8||P-value was adjusted for multiplicity control.|Chi-squared||Analysis was done using Chi-square test. 95% confidence interval for the percentage differences was calculated based on the normal approximation based on pooled variance without continuity correction.|||30.8|14.3|<0.0001
72604706|NCT03804268|144737703|SUPERIORITY||Percentage Difference|9.7||||0.0114|TWO_SIDED|95.0|2.3|17.0||P-value was adjusted for multiplicity control.|Chi-squared||Analysis was done using Chi-square test. 95% confidence interval for the percentage differences was calculated based on the normal approximation based on pooled variance without continuity correction.|||17.0|2.3|0.0114
72604707|NCT03804268|144737704|SUPERIORITY||Percentage Difference|2.1||||1|TWO_SIDED|95.0|-4.4|8.5||P-value was adjusted for multiplicity control.|Chi-squared||Analysis was done using Chi-square test. 95% confidence interval for the percentage differences was calculated based on the normal approximation based on pooled variance without continuity correction.|||8.5|-4.4|1.0000
72604708|NCT03804268|144737705|SUPERIORITY||Least Square (LS) Mean Difference|5.1|STANDARD_ERROR_OF_MEAN|0.72||0.0114|TWO_SIDED|95.0|3.7|6.5||MMRM with fixed effects: study intervention group,visit,visit by study intervention group interaction,age group,Baseline binocular DCNVA severity,iris color,emmetrope/non-emmetrope, Baseline value, and Baseline value by visit interaction was used.|MMRM|P-value was adjusted for multiplicity control.||||6.5|3.7|0.0114
72604709|NCT03804268|144737706|SUPERIORITY||Percentage Difference|18.7||||0.0114|TWO_SIDED|95.0|10.6|26.7||P-value was adjusted for multiplicity control.|Chi-squared||Analysis was done using Chi-square test. 95% confidence interval was calculated based on normal approximation based on pooled variance without continuity correction.|||26.7|10.6|0.0114
72604710|NCT03804268|144737707|SUPERIORITY||LS Mean Difference|0.8|STANDARD_ERROR_OF_MEAN|0.14||0.0114|TWO_SIDED|95.0|0.6|1.1||Analysis of covariance (ANCOVA) was used with study intervention group, age group, Baseline binocular DCNVA severity, iris color (brown/non-brown), emmetrope/non-emmetrope, and Baseline domain score as fixed effects.|ANCOVA|P-value was adjusted for multiplicity control.||||1.1|0.6|0.0114
72604711|NCT03804268|144737708|SUPERIORITY||LS Mean Difference|3.5|STANDARD_ERROR_OF_MEAN|0.55||0.0114|TWO_SIDED|95.0|2.4|4.6||MMRM with fixed effects: study intervention group,visit,visit by study intervention group interaction,age group,Baseline binocular DCNVA severity,iris color,emmetrope/non-emmetrope, Baseline value, and Baseline value by visit interaction was used.|MMRM|P-value was adjusted for multiplicity control.||||4.6|2.4|0.0114
72604712|NCT03804268|144737709|SUPERIORITY||Percentage Difference|-1.1||||1|TWO_SIDED|95.0|-7.1|5.0||P-value was adjusted for multiplicity control.|Chi-squared||Analysis was done using Chi-square test. 95% confidence interval for the percentage differences was calculated based on the normal approximation based on pooled variance without continuity correction.|||5.0|-7.1|1.0000
72604713|NCT03804268|144737710|SUPERIORITY||LS Mean Difference|2.6|STANDARD_ERROR_OF_MEAN|0.66||0.0114|TWO_SIDED|95.0|1.3|3.9||MMRM with fixed effects: study intervention group,visit,visit by study intervention group interaction,age group,Baseline binocular DCNVA severity,iris color,emmetrope/non-emmetrope, Baseline value, and Baseline value by visit interaction was used.|MMRM|P-value was adjusted for multiplicity control.||||3.9|1.3|0.0114
72604714|NCT03804268|144737711|SUPERIORITY||Percentage Difference|12.6||||0.0171|TWO_SIDED|95.0|3.5|21.6||P-value was adjusted for multiplicity control.|Chi-squared||Analysis was done using Chi-square test. 95% confidence interval for the percentage differences was calculated based on the normal approximation based on pooled variance without continuity correction.|||21.6|3.5|0.0171
72604715|NCT03804268|144737712|SUPERIORITY||LS Mean Difference|0.8|STANDARD_ERROR_OF_MEAN|0.13||0.0114|TWO_SIDED|95.0|0.5|1.1||ANCOVA was used with study intervention group, age group, baseline binocular DCNVA severity, iris color (brown/non-brown), emmetrope/non-emmetrope, and baseline domain score as fixed effects.|ANCOVA|P-value was adjusted for multiplicity control.||||1.1|0.5|0.0114
72604716|NCT03804268|144737713|SUPERIORITY||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.09||0.0114|TWO_SIDED|95.0|-0.6|-0.3||ANCOVA was used with study intervention group, age group, Baseline binocular DCNVA severity, iris color (brown/non-brown), emmetrope/non-emmetrope, and Baseline domain score as fixed effects.|ANCOVA|P-value was adjusted for multiplicity control.||||-0.3|-0.6|0.0114
72604717|NCT03804268|144737714|SUPERIORITY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.08||0.0114|TWO_SIDED|95.0|-0.4|-0.1||ANCOVA was used with study intervention group, age group, Baseline binocular DCNVA severity, iris color (brown/non-brown), emmetrope/non-emmetrope, and Baseline domain score as fixed effects.|ANCOVA|P-value was adjusted for multiplicity control.||||-0.1|-0.4|0.0114
72604718|NCT01156805|144737727|SUPERIORITY|||||||0.05|||||||Mixed Models Analysis|Mixed-effects linear regression, adjusted for clustering within schools and children to assess the effect of intervention on changes in BMI over time||||||0.05
72604719|NCT01843803|144737731|SUPERIORITY||Mean Difference (Final Values)|2.7|STANDARD_ERROR_OF_MEAN|1.5||0.029|TWO_SIDED|||||"P-Value = 0.029 after adjusting for clinical and demographic, and accounting for clustering of patients within providers.~Comparison of adjusted CARES score yielded a significant difference."|Mixed Models Analysis|A mixed model was ran with CARES as the dependent variable, adjusted for demographic and clinical measures , and provider as a random effect.||Mixed model adjusted for gender, race, education, marital status, mental health condition, substance disorder, COPD, heart failure, diabetes, coronary artery disease, study site and accounting for clustering of patients within providers.||||0.029
72604720|NCT01843803|144737733|SUPERIORITY||Odds Ratio (OR)|1.69||||0.065|TWO_SIDED|95.0|0.99|2.86||P-Value derived after adjusting model provider clustering and treating it as a random effect.|Mixed Models Analysis|||Assessed whether a person in the intervention group vs the attention control group was more likely to be probed at least once by their provider after adjusting for other measures and accounting for the provider clustering.||2.86|0.99|.065
72604721|NCT01843803|144737734|SUPERIORITY||||||<|0.05|||||||Chi-squared|||chi-square||||<0.05
72604722|NCT03311841|144737735|OTHER||Geometric least squares mean ratio|0.64|||||TWO_SIDED|95.0|0.37|1.11|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of midazolam||1.11|0.37|
72604723|NCT03311841|144737735|OTHER|Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Geometric least squares mean ratio|1.33|||||TWO_SIDED|95.0|0.77|2.31||||||Comparison of midazolam||2.31|0.77|
72604724|NCT03311841|144737735|OTHER|Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Geometric least squares mean ratio|0.95|||||TWO_SIDED|95.0|0.56|1.62||||||Comparison of midazolam||1.62|0.56|
72604725|NCT03311841|144737735|OTHER||Geometric least squares mean ratio|0.4|||||TWO_SIDED|95.0|0.23|0.7|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of midazolam||0.70|0.23|
72604726|NCT03311841|144737735|OTHER||Geometric least squares mean ratio|1.01|||||TWO_SIDED|95.0|0.53|1.93|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of dabigatran||1.93|0.53|
72604727|NCT03311841|144737735|OTHER||Geometric least squares mean ratio|2.87|||||TWO_SIDED|95.0|1.51|5.47|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of dabigatran||5.47|1.51|
72604728|NCT03311841|144737735|OTHER||Geometric least squares mean ratio|4.98|||||TWO_SIDED|95.0|2.62|9.48|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of dabigatran||9.48|2.62|
72604729|NCT03311841|144737735|OTHER||Geometric least squares mean ratio|3.39|||||TWO_SIDED|95.0|1.78|6.44|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of dabigatran||6.44|1.78|
72604730|NCT03311841|144737735|OTHER|Comparison of pitavastatin|Geometric least squares mean ratio|1.32|||||TWO_SIDED|95.0|0.76|2.31|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|||2.31|0.76|
72604731|NCT03311841|144737735|OTHER||Geometric least squares mean ratio|1.96|||||TWO_SIDED|95.0|1.12|3.42|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of pitavastatin||3.42|1.12|
72604732|NCT03311841|144737735|OTHER||Geometric least squares mean ratio|1.25|||||TWO_SIDED|95.0|0.73|2.13|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of pitavastatin||2.13|0.73|
72604733|NCT03311841|144737735|OTHER||Geometric least squares mean ratio|1.3|||||TWO_SIDED|95.0|0.74|2.27|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of pitavastatin||2.27|0.74|
72604734|NCT03311841|144737735|OTHER||Geometric least squares mean ratio|1.05|||||TWO_SIDED|95.0|0.64|1.72|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of pitavastatin lactone||1.72|0.64|
72604735|NCT03311841|144737735|OTHER||Geometric least squares mean ratio|1.45|||||TWO_SIDED|95.0|0.88|2.38|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of pitavastatin lactone||2.38|0.88|
72604736|NCT03311841|144737735|OTHER|Comparison of pitavastatin lactone|Geometric least squares mean ratio|1.09|||||TWO_SIDED|95.0|0.68|1.76|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|||1.76|0.68|
72604737|NCT03311841|144737735|OTHER|Comparison of pitavastatin lactone|Geometric least squares mean ratio|0.71|||||TWO_SIDED|95.0|0.43|1.17|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|||1.17|0.43|
72604738|NCT03311841|144737735|OTHER|Comparison of atorvastatin|Geometric least squares mean ratio|1.13|||||TWO_SIDED|95.0|0.53|2.41|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|||2.41|0.53|
72604739|NCT03311841|144737735|OTHER|Comparison of atorvastatin|Geometric least squares mean ratio|1.75|||||TWO_SIDED|95.0|0.89|3.46|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|||3.46|0.89|
72604740|NCT03311841|144737735|OTHER||Geometric least squares mean ratio|1.63|||||TWO_SIDED|95.0|0.85|3.14|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of atorvastatin||3.14|0.85|
72604741|NCT03311841|144737735|OTHER|Comparison of atorvastatin|Geometric least squares mean ratio|1.13|||||TWO_SIDED|95.0|0.57|2.22|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|||2.22|0.57|
72604742|NCT03311841|144737735|OTHER|Comparison of ortho-hydroxyatorvastatin|Geometric least squares mean ratio|1.38|||||TWO_SIDED|95.0|0.76|2.49|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|||2.49|0.76|
72604743|NCT03311841|144737735|OTHER|Comparison of ortho-hydroxyatorvastatin|Geometric least squares mean ratio|1.31|||||TWO_SIDED|95.0|0.75|2.29|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|||2.29|0.75|
72604744|NCT03311841|144737735|OTHER|Comparison of ortho-hydroxyatorvastatin|Geometric least squares mean ratio|1.09|||||TWO_SIDED|95.0|0.65|1.81|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|||1.81|0.65|
72604745|NCT03311841|144737735|OTHER|Comparison of ortho-hydroxyatorvastatin|Geometric least squares mean ratio|0.79|||||TWO_SIDED|95.0|0.46|1.33|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|||1.33|0.46|
72604746|NCT03311841|144737735|OTHER|Comparison of rosuvastatin|Geometric least squares mean ratio|0.9|||||TWO_SIDED|95.0|0.33|2.45|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|||2.45|0.33|
72604747|NCT03311841|144737735|OTHER|Comparison of rosuvastatin|Geometric least squares mean ratio|1.97|||||TWO_SIDED|95.0|0.75|5.14|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|||5.14|0.75|
72604748|NCT03311841|144737735|OTHER|Comparison of rosuvastatin|Geometric least squares mean ratio|1.25|||||TWO_SIDED|95.0|0.49|3.16|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|||3.16|0.49|
72604749|NCT03311841|144737735|OTHER|Comparison of rosuvastatin|Geometric least squares mean ratio|0.71|||||TWO_SIDED|95.0|0.27|1.86|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|||1.86|0.27|
72604750|NCT03311841|144737737|OTHER||Geometric least squares mean ratio|0.67|||||TWO_SIDED|95.0|0.4|1.11|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of midazolam||1.11|0.40|
72604751|NCT03311841|144737737|OTHER||Geometric least squares mean ratio|1.26|||||TWO_SIDED|95.0|0.76|2.09|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of midazolam||2.09|0.76|
72604752|NCT03311841|144737737|OTHER||Geometric least squares mean ratio|0.93|||||TWO_SIDED|95.0|0.57|1.52|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of midazolam||1.52|0.57|
72604753|NCT03311841|144737737|OTHER||Geometric least squares mean ratio|0.42|||||TWO_SIDED|95.0|0.25|0.7|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of midazolam||0.70|0.25|
72604754|NCT03311841|144737737|OTHER||Geometric least squares mean ratio|0.96|||||TWO_SIDED|95.0|0.53|1.73|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of dabigatran||1.73|0.53|
72604755|NCT03311841|144737737|OTHER||Geometric least squares mean ratio|2.38|||||TWO_SIDED|95.0|1.32|4.32|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of dabigatran||4.32|1.32|
72604756|NCT03311841|144737737|OTHER||Geometric least squares mean ratio|3.09|||||TWO_SIDED|95.0|1.75|5.48|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of dabigatran||5.48|1.75|
72604757|NCT03311841|144737737|OTHER||Geometric least squares mean ratio|1.46|||||TWO_SIDED|95.0|0.8|2.64|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of dabigatran||2.64|0.80|
72604758|NCT03311841|144737737|OTHER||Geometric least squares mean ratio|1.31|||||TWO_SIDED|95.0|0.78|2.2|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of pitavastatin||2.20|0.78|
72604759|NCT03311841|144737737|OTHER||Geometric least squares mean ratio|1.84|||||TWO_SIDED|95.0|1.09|3.09|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of pitavastatin||3.09|1.09|
72604760|NCT03311841|144737737|OTHER||Geometric least squares mean ratio|1.26|||||TWO_SIDED|95.0|0.77|2.09|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of pitavastatin||2.09|0.77|
72604761|NCT03311841|144737737|OTHER||Geometric least squares mean ratio|1.43|||||TWO_SIDED|95.0|0.85|2.4|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of pitavastatin||2.40|0.85|
72604762|NCT03311841|144737737|OTHER||Geometric least squares mean ratio|1.03|||||TWO_SIDED|95.0|0.68|1.56|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of pitavastatin lactone||1.56|0.68|
72604763|NCT03311841|144737737|OTHER||Geometric least squares mean ratio|1.27|||||TWO_SIDED|95.0|0.83|1.92|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of pitavastatin lactone||1.92|0.83|
72369398|NCT02003924|144248727|SUPERIORITY||Hazard Ratio (HR)|0.066|||<|0.0001|TWO_SIDED|95.0|0.054|0.081||P-value was based on a stratified log-rank test by PSA doubling time (\< 6 months, \>= 6 months) and prior or concurrent use of a bone targeting agent (yes, no) as per IXRS. Threshold for significance at 0.02 level.|Log Rank||HR was based on a Cox regression model (with treatment as the only covariate) stratified by factors defined above, and was relative to placebo with \< 1 favoring Enzalutamide.|To maintain the family-wise 2-sided type I error rate at 0.05, a parallel testing strategy between OS (with allocated type I error rate 0.03) and remaining key secondary endpoints (time to PSA progression and time to first use of new antineoplastic therapy with allocated type I error rate 0.02) was performed. Testing was performed only if the primary endpoint was statistically significant.||0.081|0.054|<0.0001
72604764|NCT03311841|144737737|OTHER||Geometric least squares mean ratio|1.09|||||TWO_SIDED|95.0|0.73|1.63|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of pitavastatin lactone||1.63|0.73|
72604765|NCT03311841|144737737|OTHER||Geometric least squares mean ratio|0.85|||||TWO_SIDED|95.0|0.56|1.29|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of pitavastatin lactone||1.29|0.56|
72604766|NCT03311841|144737737|OTHER||Geometric least squares mean ratio|1.11|||||TWO_SIDED|95.0|0.55|2.23|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of atorvastatin||2.23|0.55|
72604767|NCT03311841|144737737|OTHER||Geometric least squares mean ratio|1.66|||||TWO_SIDED|95.0|0.89|3.11|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of atorvastatin||3.11|0.89|
72604768|NCT03311841|144737737|OTHER||Geometric least squares mean ratio|1.52|||||TWO_SIDED|95.0|0.83|2.77|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of atorvastatin||2.77|0.83|
72604769|NCT03311841|144737737|OTHER||Geometric least squares mean ratio|1.45|||||TWO_SIDED|95.0|0.78|2.71|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of atorvastatin||2.71|0.78|
72604770|NCT03311841|144737737|OTHER||Geometric least squares mean ratio|1.28|||||TWO_SIDED|95.0|0.7|2.34|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of ortho-hydroxyatorvastatin||2.34|0.70|
72604771|NCT03311841|144737737|OTHER||Geometric least squares mean ratio|1.33|||||TWO_SIDED|95.0|0.78|2.28|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of ortho-hydroxyatorvastatin||2.28|0.78|
72604772|NCT03311841|144737737|OTHER||Geometric least squares mean ratio|1.03|||||TWO_SIDED|95.0|0.62|1.74|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of ortho-hydroxyatorvastatin||1.74|0.62|
72604773|NCT03311841|144737737|OTHER||Geometric least squares mean ratio|1.06|||||TWO_SIDED|95.0|0.62|1.82|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of ortho-hydroxyatorvastatin||1.82|0.62|
72604774|NCT03311841|144737737|OTHER||Geometric least squares mean ratio|1.25|||||TWO_SIDED|95.0|0.58|2.67|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of rosuvastatin||2.67|0.58|
72604775|NCT03311841|144737737|OTHER||Geometric least squares mean ratio|2.25|||||TWO_SIDED|95.0|1.09|4.63|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of rosuvastatin||4.63|1.09|
72604776|NCT03311841|144737737|OTHER||Geometric least squares mean ratio|1.46|||||TWO_SIDED|95.0|0.72|2.93|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of rosuvastatin||2.93|0.72|
72604777|NCT03311841|144737737|OTHER||Geometric least squares mean ratio|1.06|||||TWO_SIDED|95.0|0.51|2.19|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of rosuvastatin||2.19|0.51|
72604778|NCT03311841|144737738|OTHER||Geometric least squares mean ratio|0.63|||||TWO_SIDED|95.0|0.36|1.11|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of midazolam||1.11|0.36|
72604779|NCT03311841|144737738|OTHER||Geometric least squares mean ratio|1.3|||||TWO_SIDED|95.0|0.75|2.28|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of midazolam||2.28|0.75|
72604780|NCT03311841|144737738|OTHER||Geometric least squares mean ratio|0.94|||||TWO_SIDED|95.0|0.55|1.61|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of midazolam||1.61|0.55|
72604781|NCT03311841|144737738|OTHER||Geometric least squares mean ratio|0.4|||||TWO_SIDED|95.0|0.23|0.69|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of midazolam||0.69|0.23|
72604782|NCT03311841|144737738|OTHER||Geometric least squares mean ratio|1.02|||||TWO_SIDED|95.0|0.53|1.95|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of dabigatran||1.95|0.53|
72604783|NCT03311841|144737738|OTHER||Geometric least squares mean ratio|3.0|||||TWO_SIDED|95.0|1.57|5.74|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of dabigatran||5.74|1.57|
72604784|NCT03311841|144737738|OTHER||Geometric least squares mean ratio|5.28|||||TWO_SIDED|95.0|2.83|9.87|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of dabigatran||9.87|2.83|
72604785|NCT03311841|144737738|OTHER||Geometric least squares mean ratio|2.65|||||TWO_SIDED|95.0|1.39|5.07|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of dabigatran||5.07|1.39|
72604786|NCT03311841|144737738|OTHER||Geometric least squares mean ratio|1.33|||||TWO_SIDED|95.0|0.76|2.34|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of pitavastatin||2.34|0.76|
72604787|NCT03311841|144737738|OTHER||Geometric least squares mean ratio|1.97|||||TWO_SIDED|95.0|1.12|3.46|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of pitavastatin||3.46|1.12|
72604788|NCT03311841|144737738|OTHER||Geometric least squares mean ratio|1.25|||||TWO_SIDED|95.0|0.72|2.15|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of pitavastatin||2.15|0.72|
72604789|NCT03311841|144737738|OTHER||Geometric least squares mean ratio|1.34|||||TWO_SIDED|95.0|0.76|2.36|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of pitavastatin||2.36|0.76|
72604790|NCT03311841|144737738|OTHER||Geometric least squares mean ratio|1.03|||||TWO_SIDED|95.0|0.64|1.65|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of pitavastatin lactone||1.65|0.64|
72604791|NCT03311841|144737738|OTHER||Geometric least squares mean ratio|1.39|||||TWO_SIDED|95.0|0.87|2.24|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of pitavastatin lactone||2.24|0.87|
72604792|NCT03311841|144737738|OTHER||Geometric least squares mean ratio|1.08|||||TWO_SIDED|95.0|0.68|1.71|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of pitavastatin lactone||1.71|0.68|
72604793|NCT03311841|144737738|OTHER||Geometric least squares mean ratio|0.73|||||TWO_SIDED|95.0|0.45|1.17|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of pitavastatin lactone||1.17|0.45|
72604794|NCT03311841|144737738|OTHER||Geometric least squares mean ratio|1.16|||||TWO_SIDED|95.0|0.53|2.52|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of atorvastatin||2.52|0.53|
72604795|NCT03311841|144737738|OTHER||Geometric least squares mean ratio|1.8|||||TWO_SIDED|95.0|0.9|3.62|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of atorvastatin||3.62|0.90|
72604796|NCT03311841|144737738|OTHER||Geometric least squares mean ratio|1.65|||||TWO_SIDED|95.0|0.84|3.23|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of atorvastatin||3.23|0.84|
72604797|NCT03311841|144737738|OTHER||Geometric least squares mean ratio|1.17|||||TWO_SIDED|95.0|0.58|2.35|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of atorvastatin||2.35|0.58|
72604798|NCT03311841|144737738|OTHER||Geometric least squares mean ratio|1.46|||||TWO_SIDED|95.0|0.71|2.97|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of ortho-hydroxyatorvastatin||2.97|0.71|
72604799|NCT03311841|144737738|OTHER||Geometric least squares mean ratio|1.68|||||TWO_SIDED|95.0|0.89|3.19|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of ortho-hydroxyatorvastatin||3.19|0.89|
72604800|NCT03311841|144737738|OTHER||Geometric least squares mean ratio|1.16|||||TWO_SIDED|95.0|0.63|2.14|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of ortho-hydroxyatorvastatin||2.14|0.63|
72604801|NCT03311841|144737738|OTHER||Geometric least squares mean ratio|0.83|||||TWO_SIDED|95.0|0.44|1.57|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of ortho-hydroxyatorvastatin||1.57|0.44|
72604802|NCT03311841|144737738|OTHER||Geometric least squares mean ratio|1.27|||||TWO_SIDED|95.0|0.56|2.91|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of rosuvastatin||2.91|0.56|
72604803|NCT03311841|144737738|OTHER||Geometric least squares mean ratio|2.65|||||TWO_SIDED|95.0|1.21|5.81|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of rosuvastatin||5.81|1.21|
72369399|NCT02003924|144248728|SUPERIORITY||Hazard Ratio (HR)|0.208|||<|0.0001|TWO_SIDED|95.0|0.168|0.258||P-value was based on a stratified log-rank test by PSA doubling time (\< 6 months, \>= 6 months) and prior or concurrent use of a bone targeting agent (yes, no) as per IXRS. Threshold for significance at 0.02 level.|Log Rank||HR was based on a Cox regression model (with treatment as the only covariate) stratified by factors defined above, and was relative to placebo with \< 1 favoring Enzalutamide.|To maintain the family-wise 2-sided type I error rate at 0.05, a parallel testing strategy between OS (with allocated type I error rate 0.03) and remaining key secondary endpoints (time to PSA progression and time to first use of new antineoplastic therapy with allocated type I error rate 0.02) was performed. Testing was performed only if the previous endpoint was statistically significant.||0.258|0.168|<0.0001
72604804|NCT03311841|144737738|OTHER||Geometric least squares mean ratio|1.49|||||TWO_SIDED|95.0|0.7|3.18|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of rosuvastatin||3.18|0.70|
72604805|NCT03311841|144737738|OTHER||Geometric least squares mean ratio|0.95|||||TWO_SIDED|95.0|0.43|2.08|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of rosuvastatin||2.08|0.43|
72604806|NCT03311841|144737739|OTHER||Geometric least squares mean ratio|0.97|||||TWO_SIDED|95.0|0.63|1.48|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of midazolam||1.48|0.63|
72604807|NCT03311841|144737739|OTHER||Geometric least squares mean ratio|1.06|||||TWO_SIDED|95.0|0.69|1.62|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of midazolam||1.62|0.69|
72604808|NCT03311841|144737739|OTHER||Geometric least squares mean ratio|0.94|||||TWO_SIDED|95.0|0.62|1.41|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of midazolam||1.41|0.62|
72604809|NCT03311841|144737739|OTHER||Geometric least squares mean ratio|0.55|||||TWO_SIDED|95.0|0.36|0.83|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of midazolam||0.83|0.36|
72604810|NCT03311841|144737739|OTHER||Geometric least squares mean ratio|0.84|||||TWO_SIDED|95.0|0.44|1.61|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of dabigatran||1.61|0.44|
72604811|NCT03311841|144737739|OTHER||Geometric least squares mean ratio|1.71|||||TWO_SIDED|95.0|0.89|3.27|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of dabigatran||3.27|0.89|
72604812|NCT03311841|144737739|OTHER||Geometric least squares mean ratio|1.75|||||TWO_SIDED|95.0|0.93|3.27|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of dabigatran||3.27|0.93|
72604813|NCT03311841|144737739|OTHER||Geometric least squares mean ratio|0.72|||||TWO_SIDED|95.0|0.38|1.38|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of dabigatran||1.38|0.38|
72604814|NCT03311841|144737739|OTHER||Geometric least squares mean ratio|1.49|||||TWO_SIDED|95.0|0.92|2.4|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of pitavastatin||2.40|0.92|
72604815|NCT03311841|144737739|OTHER||Geometric least squares mean ratio|1.84|||||TWO_SIDED|95.0|1.14|2.98|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of pitavastatin||2.98|1.14|
72604816|NCT03311841|144737739|OTHER||Geometric least squares mean ratio|1.33|||||TWO_SIDED|95.0|0.84|2.11|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of pitavastatin||2.11|0.84|
72604817|NCT03311841|144737739|OTHER||Geometric least squares mean ratio|1.47|||||TWO_SIDED|95.0|0.91|2.38|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of pitavastatin||2.38|0.91|
72604818|NCT03311841|144737739|OTHER||Geometric least squares mean ratio|1.19|||||TWO_SIDED|95.0|0.81|1.75|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of pitavastatin lactone||1.75|0.81|
72604819|NCT03311841|144737739|OTHER||Geometric least squares mean ratio|1.2|||||TWO_SIDED|95.0|0.82|1.76|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of pitavastatin lactone||1.76|0.82|
72604820|NCT03311841|144737739|OTHER||Geometric least squares mean ratio|1.08|||||TWO_SIDED|95.0|0.75|1.57|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of pitavastatin lactone||1.57|0.75|
72604821|NCT03311841|144737739|OTHER||Geometric least squares mean ratio|0.89|||||TWO_SIDED|95.0|0.61|1.31|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of pitavastatin lactone||1.31|0.61|
72604822|NCT03311841|144737739|OTHER||Geometric least squares mean ratio|1.48|||||TWO_SIDED|95.0|0.58|3.75|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of atorvastatin||3.75|0.58|
72604823|NCT03311841|144737739|OTHER||Geometric least squares mean ratio|2.54|||||TWO_SIDED|95.0|1.11|5.85|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of atorvastatin||5.85|1.11|
72604824|NCT03311841|144737739|OTHER||Geometric least squares mean ratio|2.16|||||TWO_SIDED|95.0|0.97|4.81|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of atorvastatin||4.81|0.97|
72604825|NCT03311841|144737739|OTHER||Geometric least squares mean ratio|2.94|||||TWO_SIDED|95.0|1.28|6.77|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of atorvastatin||6.77|1.28|
72604826|NCT03311841|144737739|OTHER||Geometric least squares mean ratio|1.11|||||TWO_SIDED|95.0|0.59|2.07|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of ortho-hydroxyatorvastatin||2.07|0.59|
72604827|NCT03311841|144737739|OTHER||Geometric least squares mean ratio|1.24|||||TWO_SIDED|95.0|0.71|2.17|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of ortho-hydroxyatorvastatin||2.17|0.71|
72604828|NCT03311841|144737739|OTHER||Geometric least squares mean ratio|0.94|||||TWO_SIDED|95.0|0.55|1.62|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of ortho-hydroxyatorvastatin||1.62|0.55|
72604829|NCT03311841|144737739|OTHER||Geometric least squares mean ratio|1.12|||||TWO_SIDED|95.0|0.64|1.96|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of ortho-hydroxyatorvastatin||1.96|0.64|
72604830|NCT03311841|144737739|OTHER||Geometric least squares mean ratio|1.1|||||TWO_SIDED|95.0|0.46|2.64|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of rosuvastatin||2.64|0.46|
72604831|NCT03311841|144737739|OTHER||Geometric least squares mean ratio|1.87|||||TWO_SIDED|95.0|0.81|4.32|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of rosuvastatin||4.32|0.81|
72604832|NCT03311841|144737739|OTHER||Geometric least squares mean ratio|1.13|||||TWO_SIDED|95.0|0.51|2.53|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of rosuvastatin||2.53|0.51|
72604833|NCT03311841|144737739|OTHER||Geometric least squares mean ratio|1.04|||||TWO_SIDED|95.0|0.45|2.41|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of rosuvastatin||2.41|0.45|
72604834|NCT03311841|144737740|OTHER||Geometric least squares mean ratio|1.68|||||TWO_SIDED|95.0|0.78|3.62|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of midazolam||3.62|0.78|
72604835|NCT03311841|144737740|OTHER||Geometric least squares mean ratio|1.3|||||TWO_SIDED|95.0|0.75|2.23|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of pitavastatin||2.23|0.75|
72604836|NCT03311841|144737740|OTHER||Geometric least squares mean ratio|1.98|||||TWO_SIDED|95.0|1.15|3.41|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of pitavastatin||3.41|1.15|
72604837|NCT03311841|144737740|OTHER||Geometric least squares mean ratio|0.98|||||TWO_SIDED|95.0|0.58|1.66|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of pitavastatin||1.66|0.58|
72604838|NCT03311841|144737740|OTHER||Geometric least squares mean ratio|1.03|||||TWO_SIDED|95.0|0.52|2.03|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of pitavastatin lactone||2.03|0.52|
72604839|NCT03311841|144737740|OTHER||Geometric least squares mean ratio|1.51|||||TWO_SIDED|95.0|0.77|2.97|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of pitavastatin lactone||2.97|0.77|
72604840|NCT03311841|144737740|OTHER||Geometric least squares mean ratio|1.07|||||TWO_SIDED|95.0|0.56|2.05|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of pitavastatin lactone||2.05|0.56|
72604841|NCT03311841|144737740|OTHER||Geometric least squares mean ratio|0.6|||||TWO_SIDED|95.0|0.3|1.17|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of pitavastatin lactone||1.17|0.30|
72604842|NCT03311841|144737740|OTHER||Geometric least squares mean ratio|1.57|||||TWO_SIDED|95.0|0.84|2.94|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of atovastatin||2.94|0.84|
72604843|NCT03311841|144737740|OTHER||Geometric least squares mean ratio|1.49|||||TWO_SIDED|95.0|0.81|2.73|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of atovastatin||2.73|0.81|
72604844|NCT03311841|144737740|OTHER||Geometric least squares mean ratio|1.44|||||TWO_SIDED|95.0|0.84|2.47|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of ortho-hydroxyatorvastatin||2.47|0.84|
72604845|NCT03311841|144737740|OTHER||Geometric least squares mean ratio|1.06|||||TWO_SIDED|95.0|0.63|1.78|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of ortho-hydroxyatorvastatin||1.78|0.63|
72604846|NCT03311841|144737740|OTHER||Geometric least squares mean ratio|1.85|||||TWO_SIDED|95.0|0.95|3.61|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of rosuvastatin||3.61|0.95|
72604847|NCT03311841|144737740|OTHER||Geometric least squares mean ratio|3.1|||||TWO_SIDED|95.0|1.64|5.86|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of rosuvastatin||5.86|1.64|
72604848|NCT03311841|144737740|OTHER||Geometric least squares mean ratio|1.75|||||TWO_SIDED|95.0|0.95|3.24|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of rosuvastatin||3.24|0.95|
72604849|NCT03138577|144737753|OTHER||||||||||||||||||Counts and percentages of cases with paralysis were calculated separately for each volume of local anesthetic.|||
72604850|NCT03138577|144737754|OTHER|||||||||||||||Counts and percentages of cases with paralysis were calculated separately for each volume of local anesthetic.|||Counts and percentages of cases with paralysis were calculated separately for each volume of local anesthetic.|||
72604851|NCT03138577|144737755|OTHER||Median Difference (Final Values)|7.5||||0.01|TWO_SIDED||||||Sign test|||||||0.01
72604852|NCT03138577|144737755|OTHER||Median Difference (Final Values)|0.0||||1|TWO_SIDED||||||Sign test|||||||1.00
72604853|NCT03138577|144737756|OTHER||||||||||||||||||Dose response data was fit with a non-parametric smoothing technique for locally weighted regression (lowess) to produce a dose response curve.|||
72604854|NCT03138577|144737757|OTHER||||||||||||||||||Dose response data was fit with a non-parametric smoothing technique for locally weighted regression (lowess) to produce a dose response curve.|||
72604855|NCT03138577|144737758|OTHER||Median Difference (Final Values)|-1.0||||0.01|TWO_SIDED||||||Sign test|||||||0.01
72604856|NCT03138577|144737758|OTHER||Median Difference (Final Values)|0.0||||1|TWO_SIDED||||||Sign test|||||||1.00
72604857|NCT03138577|144737759|OTHER|||||||0.08|||||||Wilcoxon (Mann-Whitney)|||||||0.08
72604858|NCT01852513|144737780|SUPERIORITY|||||||0.391|||||||t-test, 2 sided|||||||0.391
72604859|NCT01852513|144737781|SUPERIORITY|||||||0.789|||||||t-test, 2 sided|||||||0.789
72604860|NCT01852513|144737782|SUPERIORITY|||||||0.778|||||||t-test, 2 sided|||||||0.778
72604861|NCT02686164|144737788|OTHER||Geometric Mean Ratio|0.914|||||TWO_SIDED|90.0|0.85|0.983||||||AUC(0-24) of Midazolam: Cycle 1 Day 1, Lenvatinib (single-dose) + Midazolam Versus (vs.) Cycle 1 Day -3, Midazolam||0.983|0.850|
72604862|NCT02686164|144737788|OTHER||Geometric Mean Ratio|1.148|||||TWO_SIDED|90.0|0.938|1.404||||||AUC(0-24) of Midazolam: Cycle 1 Day 14, Lenvatinib (steady state) + Midazolam vs. Cycle 1 Day -3, Midazolam||1.404|0.938|
72604863|NCT02686164|144737788|OTHER||Geometric Mean Ratio|1.12|||||TWO_SIDED|90.0|0.94|1.335||||||AUC(0-24) of 1'-hydroxy midazolam: Cycle 1 Day 1, Lenvatinib (single-dose) + Midazolam vs. Cycle 1 Day -3, Midazolam||1.335|0.940|
72604864|NCT02686164|144737788|OTHER||Geometric Mean Ratio|1.199|||||TWO_SIDED|90.0|1.057|1.36||||||AUC(0-24) of 1'-hydroxy midazolam: Cycle 1 Day 14, Lenvatinib (steady-state) + Midazolam vs.Cycle 1 Day -3, Midazolam||1.360|1.057|
72604865|NCT02686164|144737789|OTHER||Geometric Mean Ratio|0.862|||||TWO_SIDED|90.0|0.753|0.988||||||Cmax of Midazolam: Cycle 1 Day 1, Lenvatinib (single-dose) + Midazolam vs. Cycle 1 Day -3, Midazolam||0.988|0.753|
72604866|NCT02686164|144737789|OTHER||Geometric Mean Ratio|1.027|||||TWO_SIDED|90.0|0.852|1.238||||||Cmax of Midazolam: Cycle 1 Day 14, Lenvatinib (steady state) + Midazolam vs. Cycle 1 Day -3, Midazolam||1.238|0.852|
72604867|NCT02686164|144737789|OTHER||Geometric Mean Ratio|1.055|||||TWO_SIDED|90.0|0.879|1.268||||||Cmax of 1'-hydroxy midazolam: Cycle 1 Day 1, Lenvatinib (single-dose) + Midazolam vs. Cycle 1 Day -3, Midazolam||1.268|0.879|
72604868|NCT02686164|144737789|OTHER||Geometric Mean Ratio|0.94|||||TWO_SIDED|90.0|0.845|1.046||||||Cmax of 1'-hydroxy midazolam: Cycle 1 Day 14, Lenvatinib (steady state) + Midazolam vs. Cycle 1 Day -3, Midazolam||1.046|0.845|
72604869|NCT00672633|144737804|SUPERIORITY_OR_OTHER||Mean Difference (Net)|20.0||||0.52||95.0|||||ANOVA|Repeated measures||The study was designed with 80% power to detect a net improvement of Triglyceride elevles with a sample size of 60.||||0.52
72604870|NCT00672633|144737805|SUPERIORITY_OR_OTHER||Mean Difference (Net)|16.0||||0.06||95.0|||||ANOVA|Repeated Measures||No power calculations done for this outcomes||||0.06
72604871|NCT00672633|144737806|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.3||||0.27||95.0|||||ANOVA|Repeated Measures||No power calculations were conducted for this outcome||||0.27
72604872|NCT01689441|144737812|SUPERIORITY_OR_OTHER_LEGACY|||||||0.25|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.25
72604873|NCT01689441|144737813|SUPERIORITY_OR_OTHER_LEGACY|||||||0.51|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.51
72604874|NCT01689441|144737814|SUPERIORITY_OR_OTHER_LEGACY|||||||0.54|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.54
72604875|NCT04235504|144737859|SUPERIORITY||Mean Difference (Final Values)|-1.42|||<|0.0001|TWO_SIDED|95.0|-1.74|-1.1|||linear mixed model|||||-1.10|-1.74|<0.0001
72604876|NCT04235504|144737860|SUPERIORITY||Mean Difference (Final Values)|27.59|||<|0.0001|TWO_SIDED|95.0|21.59|33.6|||linear mixed model|||||33.60|21.59|<0.0001
72604877|NCT04235504|144737861|SUPERIORITY||Mean Difference (Final Values)|-27.86|||<|0.0001|TWO_SIDED|95.0|-34.16|-21.55|||linear mixed model|||||-21.55|-34.16|<0.0001
72604878|NCT04235504|144737862|SUPERIORITY||Mean Difference (Final Values)|0.12||||0.6227|TWO_SIDED|95.0|-0.37|0.61|||linear mixed model|||||0.61|-0.37|0.6227
72604879|NCT04235504|144737863|SUPERIORITY||Mean Difference (Final Values)|-1.08|||||TWO_SIDED|95.0|-2.17|0.0||Due to the small sample size, p value will not be meaningful. Therefore, p value is not presented|linear mixed model|||||0.00|-2.17|
72604880|NCT04235504|144737864|SUPERIORITY||Mean Difference (Final Values)|28.81|||||TWO_SIDED|95.0|12.34|45.28||Due to the small sample size, p value will not be meaningful. Therefore, p value is not presented|linear mixed model|||||45.28|12.34|
72604881|NCT04235504|144737865|SUPERIORITY||Mean Difference (Final Values)|-28.45|||||TWO_SIDED|95.0|-45.27|-11.64||Due to the small sample size, p value will not be meaningful. Therefore, p value is not presented|linear mixed model|||||-11.64|-45.27|
72604882|NCT04235504|144737866|SUPERIORITY||Mean Difference (Final Values)|-0.36|||||TWO_SIDED|95.0|-1.32|0.59||Due to the small sample size, p value will not be meaningful. Therefore, p value is not presented|linear mixed model|||||0.59|-1.32|
72604883|NCT00870467|144737873|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.001
72604884|NCT00870467|144737874|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Fisher Exact|||||||<0.001
72604885|NCT00870467|144737875|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Fisher Exact|||||||<0.001
72604886|NCT00870467|144737876|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Fisher Exact|||||||<0.001
72604887|NCT00870467|144737877|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.001
72604888|NCT00870467|144737878|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Fisher Exact|||||||<0.001
72604889|NCT00069823|144737901|SUPERIORITY_OR_OTHER||Incidence-Rate Ratio|1.2||||0.35|TWO_SIDED|95.0|0.8|2.0||P values are for the treatment effect of esomeprazole as compared with placebo.|Negative binomial regression|||Rates were compared with incidence-rate ratios (IRR). The IRR and P values were estimated with the use of negative binomial regression models with robust variance estimates.||2.0|0.8|0.35
72604890|NCT00069823|144737902|SUPERIORITY_OR_OTHER||Incidence-Rate Ratio|0.9||||0.79|TWO_SIDED|95.0|0.6|1.5||P values are for the treatment effect of esomeprazole as compared with placebo.|Negative binomial regression|||Rates were compared with incidence-rate ratios (IRR). The IRR and P values were estimated with the use of negative binomial regression models with robust variance estimates.||1.5|0.6|0.79
72604891|NCT00069823|144737903|SUPERIORITY_OR_OTHER||Incidence-Rate Ratio|1.1||||0.66|TWO_SIDED|95.0|0.8|1.5||P values are for the treatment effect of esomeprazole as compared with placebo.|Negative binomial regression|||The rates of EPACs were compared using incidence-rate ratios (IRR). IRR and P value were estimated with the use of negative binomial regression models with robust variance estimates.||1.5|0.8|0.66
72604892|NCT00069823|144737904|SUPERIORITY_OR_OTHER||Incidence-Rate Ratio|0.9||||0.62|TWO_SIDED|95.0|0.6|1.3||P values are for the treatment effect of esomeprazole as compared with placebo.|Negative binomial regression|||Rates were compared with incidence-rate ratios (IRR). The IRR and P values were estimated with the use of negative binomial regression models with robust variance estimates.||1.3|0.6|0.62
72604893|NCT00069823|144737905|SUPERIORITY_OR_OTHER||Incidence-Rate Ratio|1.0||||0.87|TWO_SIDED|95.0|0.8|1.3||P values are for the treatment effect of esomeprazole as compared with placebo.|Negative binomial regression|||Rates were compared with incidence-rate ratios (IRR). The IRR and P values were estimated with the use of negative binomial regression models with robust variance estimates.||1.3|0.8|0.87
72604894|NCT00069823|144737906|SUPERIORITY_OR_OTHER||Incidence-Rate Ratio|0.9||||0.62||95.0|0.7|1.3||P values are for the treatment effect of esomeprazole as compared with placebo.|Negative binomial regression|||Incidence-rate ratios and P values were estimated with the use of negative binomial regression models with robust variance estimates.||1.3|0.7|0.62
72604895|NCT00069823|144737907|SUPERIORITY_OR_OTHER||Incidence-Rate Ratio|0.9||||0.7|TWO_SIDED|95.0|0.6|1.4||P values are for the treatment effect of esomeprazole as compared with placebo.|Negative binomial regression|||Incidence-rate ratios and P values were estimated with the use of negative binomial regression models with robust variance estimates.||1.4|0.6|0.70
72604896|NCT00069823|144737908|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.03|STANDARD_ERROR_OF_MEAN|0.03||0.36|TWO_SIDED|95.0|-0.03|0.08||P values were calculated with the use of linear regression.|Regression, Linear||Treatment effect is the difference in mean change in the esomeprazole group minus the mean change in the placebo group, e.g. 0.00 - (-0.02) = -0.03 (rounding)|The treatment effect is the mean change in the Esomeprazole group - mean change in placebo group||0.08|-0.03|0.36
72604897|NCT00069823|144737909|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.03|STANDARD_ERROR_OF_MEAN|0.03||0.3|TWO_SIDED|95.0|-0.03|0.09|||Regression, Linear||Treatment effect is the difference in mean change in the esomeprazole group minus the mean change in the placebo group|||0.09|-0.03|0.30
72604898|NCT00069823|144737910|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.0|STANDARD_ERROR_OF_MEAN|5.1||0.24|TWO_SIDED|95.0|-4.0|16.0|||Regression, Linear||Treatment effect is the difference in mean change in the esomeprazole group minus the mean change in the placebo group|||16.0|-4.0|0.24
72604899|NCT00069823|144737911|SUPERIORITY_OR_OTHER||Treatment Effect|-1.8||||0.04||95.0|-3.6|-0.1|||Regression, Linear|||||-0.1|-3.6|0.04
72604900|NCT00069823|144737912|SUPERIORITY_OR_OTHER||Treatment Effect|0.1|STANDARD_ERROR_OF_MEAN|0.1||0.11|TWO_SIDED|95.0|0.0|0.2|||Regression, Linear||Treatment effect is the difference in mean change in the esomeprazole group minus the mean change in the placebo group|||0.2|0.0|0.11
72416256|NCT01972841|144343307|SUPERIORITY||Least squares mean diffeence|-0.37|STANDARD_ERROR_OF_MEAN|0.11|<|0.001|TWO_SIDED|95.0|-0.59|-0.15|||Stratified rank ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (mirabegron 25 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||-0.15|-0.59|<0.001
72604901|NCT00069823|144737913|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.01||0.11|TWO_SIDED|95.0|-0.05|-0.02|||Regression, Linear||Treatment effect is the difference in mean change in the esomeprazole group minus the mean change in the placebo group|||-0.02|-0.05|0.11
72604902|NCT00069823|144737914|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1|STANDARD_ERROR_OF_MEAN|0.1||0.33|TWO_SIDED|95.0|-0.2|0.1|||Regression, Linear||Treatment effect is the difference in mean change in the esomeprazole group minus the mean change in the placebo group|||0.1|-0.2|0.33
72604903|NCT00069823|144737915|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.9|STANDARD_ERROR_OF_MEAN|0.6||0.16|TWO_SIDED|95.0|-2.0|0.4|||Regression, Linear||Treatment effect is the difference in mean change in the esomeprazole group minus the mean change in the placebo group|||0.4|-2.0|0.16
72604904|NCT00069823|144737916|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.5|STANDARD_ERROR_OF_MEAN|0.78||0.56|TWO_SIDED|95.0|-1.1|2.2|||Regression, Linear||Treatment effect is the difference in mean change in the esomeprazole group minus the mean change in the placebo group|||2.2|-1.1|0.56
72604905|NCT00069823|144737917|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.01|STANDARD_ERROR_OF_MEAN|0.03||0.76|TWO_SIDED|95.0|-0.05|0.07|||Regression, Linear||Treatment effect is the difference in mean change in the esomeprazole group minus the mean change in the placebo group|||0.07|-0.05|0.76
72604906|NCT00069823|144737918|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.2|STANDARD_ERROR_OF_MEAN|0.3||0.39|TWO_SIDED|95.0|-0.8|0.3|||Regression, Linear||Treatment effect is the difference in mean change in the esomeprazole group minus the mean change in the placebo group|||0.3|-0.8|0.39
72604907|NCT03284853|144737925|OTHER|The primary analysis was performed on the ITT population with imputation by Markov Chain Monte Carlo method.|||||<|0.05||||||Linear model with IOP at the given visit and time point as the response, baseline IOP as a covariate, and treatment as a main effect factor at each time point (08:00, 10:00, and 16:00 hours at the Week 2, Week 6, and Month 3 Visits).|Regression, Linear|Non-inferiority for PG324 was concluded if the UL of the 95% CI was ≤ l.5 mmHg at all 9 time points and ≤ l.0 mmHg at the majority of time points||Assuming no difference between PG324 and Ganfort, a two-tailed alpha of 0.05 (2-sided 95% CI) at each of 9 time points, a common SD of 3.5 mmHg, and a correlation between time points of ≤ 0.60, 200 ITT subjects per arm were necessary to have 85% power to show clinical non-inferiority of PG324 to Ganfort in the mean change from baseline IOP.||||<0.05
72604908|NCT00377637|144737959|SUPERIORITY_OR_OTHER|||||||0.478||95.0|||||Regression, Logistic|Covariates included Treatment, Race, Geographical Region, and WHO Lupus Nephritis Class V and specified interaction terms.||||||0.478
72604909|NCT00377637|144737960|SUPERIORITY_OR_OTHER|||||||0.003||95.0||||Testing at the alpha=0.05 level was applied with no adjustments made for multiplicity.|Log Rank|||The difference in Kaplan-Meier survival curves between treatment groups (MMF-AZA) was assessed using a log-rank test, which is a non-parametric test to compare the survival distributions of two groups commonly used to analyze time-to-event endpoints.||||0.003
72604910|NCT00814138|144737980|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-488.0||||0.26|TWO_SIDED|95.0|-2443.4|1467.3|||Wilcoxon (Mann-Whitney)|||If a study participant terminated, their last results were pulled forward.||1467.3|-2443.4|0.26
72604911|NCT00814138|144737981|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.9||||0.26|TWO_SIDED|95.0|-9.7|5.8|||Wilcoxon (Mann-Whitney)|||If a study participant terminated, their last results were pulled forward.||5.8|-9.7|0.26
72604912|NCT00814138|144737982|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.7||||0.29|TWO_SIDED|95.0|-4.9|1.5|||t-test, 2 sided|||If a study participant terminated, their last results were pulled forward.||1.5|-4.9|0.29
72604913|NCT00814138|144737983|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.2||||0.28|TWO_SIDED|95.0|-6.3|1.8|||t-test, 2 sided|||If a study participant terminated, their last results were pulled forward.||1.8|-6.3|0.28
72604914|NCT00814138|144737984|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9||||0.82|TWO_SIDED|95.0|-7.2|5.4|||Wilcoxon (Mann-Whitney)|||If a study participant terminated, their last results were pulled forward.||5.4|-7.2|0.82
72604915|NCT00814138|144737985|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.5||||0.21|TWO_SIDED|95.0|-3.7|0.8|||t-test, 2 sided|||If a study participant terminated, their last results were pulled forward.||0.8|-3.7|0.21
72604916|NCT00814138|144737986|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.3||||0.09|TWO_SIDED|95.0|-7.1|0.5|||t-test, 2 sided|||If a study participant terminated, their last results were pulled forward.||0.5|-7.1|0.09
72604917|NCT00583908|144737991|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-27.5|STANDARD_DEVIATION|17.1|<|0.0001||95.0||||Paired t-test|t-test, 1 sided||mean difference was senofilcon A minus balafilcon A|Alternative Hypothesis was senofilcon A toric was superior to balafilcon A toric by having less degrees of rotation||||<0.0001
72604918|NCT00583908|144737991|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.4|STANDARD_DEVIATION|17.8||0.0002||95.0||||paired t-test|t-test, 1 sided||mean difference is senofilcon A minus lotrafilcon B|Hypothesis was senofilcon A toric was superior to lotrafilcon B toric by having less degree of rotation||||0.0002
72604919|NCT00583908|144737991|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-27.0|STANDARD_DEVIATION|12.4|<|0.0001||95.0||||paired t-test|t-test, 1 sided||Mean difference is senofilcon A minus omafilcon A|Hypothesis was senofilcon A toric was superior to omafilcon A toric by having less degree of rotation||||<0.0001
72604920|NCT00583908|144737992|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.13|STANDARD_DEVIATION|0.15||0.0083||95.0|||||t-test, 1 sided||Mean difference was senofilcon A minus balafilcon A|Alternative hypothesis was senofilcon A toric was superior to balafilcon A toric by having a lower logMAR score||||0.0083
72604921|NCT00583908|144737992|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.06|STANDARD_DEVIATION|0.09||0.052||95.0|||||t-test, 1 sided||Mean difference was senofilcon A minus lotrafilcon B|Alternative hypothesis was senofilcon A toric was superior to lotrafilcon B toric by having a lower logMAR score||||0.052
72604922|NCT00583908|144737992|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.13|STANDARD_DEVIATION|0.14||0.015||95.0|||||t-test, 1 sided||Mean difference was senofilcon A minus omafilcon A|Alternative hypothesis was senofilcon A toric was superior to omafilcon A toric by having a lower logMAR score||||0.015
72604923|NCT00583908|144737993|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.7|STANDARD_DEVIATION|6.5||0.16||95.0|||||t-test, 1 sided||Mean difference is senofilcon A minus balafilcon A|||||0.16
72604924|NCT00583908|144737993|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_DEVIATION|3.5||0.73||95.0|||||t-test, 1 sided||Mean difference is senofilcon A minus lotrafilcon B|||||0.73
72604925|NCT00583908|144737993|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.3|STANDARD_DEVIATION|4.4||0.044||95.0|||||t-test, 1 sided||Mean difference was senofilcon A minus omafilcon A|||||0.044
72604926|NCT00583908|144737994|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-3.1|STANDARD_DEVIATION|5.0||0.044||95.0|||||t-test, 1 sided||Mean difference is senofilcon A minus balafilcon A|||||0.044
72604927|NCT00583908|144737994|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.4|STANDARD_DEVIATION|4.7||0.31||95.0|||||t-test, 1 sided||Mean difference is senofilcon A minus lotrafilcon B|||||0.31
72604928|NCT00583908|144737994|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.5|STANDARD_DEVIATION|5.9||0.44||95.0|||||t-test, 1 sided||Mean difference is senofilcon A minus omafilcon A|||||0.44
72604929|NCT00583908|144737995|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.5|STANDARD_DEVIATION|6.5||0.78||95.0|||||t-test, 1 sided||Mean difference is senofilcon A minus balafilcon A|||||0.78
72604930|NCT00583908|144737995|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7|STANDARD_DEVIATION|6.3||0.68||95.0|||||t-test, 1 sided||Mean difference is senofilcon A minus lotrafilcon B|||||0.68
72604931|NCT00583908|144737995|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|STANDARD_DEVIATION|7.6||0.78||95.0|||||t-test, 1 sided||Mean difference is senofilcon A minus omafilcon A|||||0.78
72604932|NCT00583908|144737996|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.1|STANDARD_DEVIATION|6.5||0.11||95.0|||||t-test, 1 sided||Mean difference is senofilcon A minus balafilcon A|||||0.11
72604933|NCT00583908|144737996|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.3|STANDARD_DEVIATION|4.3||0.31||95.0|||||t-test, 1 sided||Mean difference is senofilcon A minus lotrafilcon B|||||0.31
72604934|NCT00583908|144737996|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-3.0|STANDARD_DEVIATION|6.3||0.16||95.0|||||t-test, 1 sided||Mean difference is senofilcon A minus omafilcon A|||||0.16
72604935|NCT00583908|144737997|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.9|STANDARD_DEVIATION|6.8||0.061||95.0|||||t-test, 1 sided||Mean difference is senofilcon A minus balafilcon A|||||0.061
72604936|NCT00583908|144737997|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.8|STANDARD_DEVIATION|3.9||0.47||95.0|||||t-test, 1 sided||Mean difference is senofilcon A minus lotrafilcon B|||||0.47
72604937|NCT00583908|144737997|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0|STANDARD_DEVIATION|3.6||0.38||95.0|||||t-test, 1 sided||Mean difference is senofilcon A minus omafilcon A|||||0.38
72604938|NCT00583908|144737998|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.4|STANDARD_DEVIATION|3.5||0.17||95.0|||||t-test, 1 sided||Mean difference is senofilcon A minus balafilcon A|||||0.17
72604939|NCT00583908|144737998|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2|STANDARD_DEVIATION|5.0||0.89||95.0|||||t-test, 1 sided||Mean difference is senofilcon A minus lotrafilcon B|||||0.89
72604940|NCT00583908|144737998|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.1|STANDARD_DEVIATION|5.8||0.56||95.0|||||t-test, 1 sided||Mean difference is senofilcon A minus omafilcon A|||||0.56
72604941|NCT00583908|144737999|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.0|STANDARD_DEVIATION|6.8||0.008||95.0|||||t-test, 1 sided||Mean difference is senofilcon A minus balafilcon A|||||0.0080
72604942|NCT00583908|144737999|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.9|STANDARD_DEVIATION|3.1||0.0049||95.0|||||t-test, 1 sided||Mean difference is senofilcon A minus lotrafilcon B|||||0.0049
72604943|NCT00583908|144737999|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.4|STANDARD_DEVIATION|5.6||0.0058||95.0|||||t-test, 1 sided||Mean difference is senofilcon A minus omafilcon A|||||0.0058
72604944|NCT00583908|144738000|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.2|STANDARD_DEVIATION|3.7||0.27||95.0|||||t-test, 1 sided||Mean difference is senofilcon A minus balafilcon A|||||0.27
72604945|NCT00583908|144738000|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_DEVIATION|6.0||0.85||95.0|||||t-test, 1 sided||Mean difference is senofilocon A minus lotrafilcon B|||||0.85
72604946|NCT00583908|144738000|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3|STANDARD_DEVIATION|2.6||0.73||95.0|||||t-test, 1 sided||Mean difference is senofilcon A minus omifilcon A|||||0.73
72604947|NCT03286218|144738029|NON_INFERIORITY|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 14 mm.|Least Squares (LS) Mean Difference|32.4|||||TWO_SIDED|90.0|28.4|36.4||||||||36.4|28.4|
72604948|NCT03286218|144738029|NON_INFERIORITY|The non-inferiority (NI) margin for Lasmiditan doses vs Placebo is 14 mm.|LS Mean Difference|15.6|||||TWO_SIDED|90.0|11.7|19.6||||||||19.6|11.7|
72604949|NCT03286218|144738029|NON_INFERIORITY|The non-inferiority (NI) margin for Lasmiditan doses vs Placebo is 14 mm.|LS Mean Difference|20.3|||||TWO_SIDED|90.0|16.3|24.3||||||||24.3|16.3|
72604950|NCT03286218|144738029|NON_INFERIORITY|The non-inferiority (NI) margin for Lasmiditan doses vs Placebo is 14 mm.|LS Mean Difference|23.6|||||TWO_SIDED|90.0|19.6|27.6||||||||27.6|19.6|
72604951|NCT03286218|144738029|NON_INFERIORITY|The non-inferiority (NI) margin for Alprazolam and Lasmiditan 100 mg dose is 5 mm.|LS Mean Difference|16.8|||||TWO_SIDED|90.0|12.8|20.8||||||||20.8|12.8|
72604952|NCT03286218|144738029|NON_INFERIORITY|The non-inferiority (NI) margin for Alprazolam and Lasmiditan 200 mg dose is 5 mm.|LS Mean Difference|12.1|||||TWO_SIDED|90.0|8.1|16.1||||||||16.1|8.10|
72604953|NCT03286218|144738029|NON_INFERIORITY|The non-inferiority (NI) margin for Alprazolam and Lasmiditan 400 mg dose is 5 mm.|LS Mean Difference|8.79|||||TWO_SIDED|90.0|4.8|12.8||||||||12.8|4.8|
72604954|NCT03286218|144738032|OTHER||LS Mean Difference|33.1|||||TWO_SIDED|90.0|28.5|37.7||||||Overall Drug Liking||37.7|28.5|
72604955|NCT03286218|144738032|OTHER||LS Mean Difference|18.6|||||TWO_SIDED|90.0|14.0|23.2||||||Overall Drug Liking||23.2|14.0|
72604956|NCT03286218|144738032|OTHER||LS Mean Difference|19.1|||||TWO_SIDED|90.0|14.5|23.8||||||Overall Drug Liking||23.8|14.5|
72604957|NCT03286218|144738032|OTHER||LS Mean Difference|24.3|||||TWO_SIDED|90.0|19.7|28.9||||||Overall Drug Liking||28.9|19.7|
72604958|NCT03286218|144738032|OTHER||LS Mean Difference|34.0|||||TWO_SIDED|90.0|29.1|38.9||||||Take drug again||38.9|29.1|
72604959|NCT03286218|144738032|OTHER||LS Mean Difference|19.1|||||TWO_SIDED|90.0|14.2|24.0||||||Take drug again||24.0|14.2|
72604960|NCT03286218|144738032|OTHER||LS Mean Difference|20.6|||||TWO_SIDED|90.0|15.7|25.6||||||Take drug again||25.6|15.7|
72604961|NCT03286218|144738032|OTHER||LS Mean Difference|25.3|||||TWO_SIDED|90.0|20.3|30.2||||||Take drug again||30.2|20.3|
72604962|NCT03286218|144738032|OTHER||LS Mean Difference|69.7|||||TWO_SIDED|90.0|62.1|77.4||||||Good effects||77.4|62.1|
72604963|NCT03286218|144738032|OTHER||LS Mean Difference|35.5|||||TWO_SIDED|90.0|27.9|43.2||||||Good effects||43.2|27.9|
72604964|NCT03286218|144738032|OTHER||LS Mean Difference|52.0|||||TWO_SIDED|90.0|44.4|59.7||||||Good effects||59.7|44.4|
72604965|NCT03286218|144738032|OTHER||LS Mean Difference|53.0|||||TWO_SIDED|90.0|45.4|60.6||||||Good effects||60.6|45.4|
72604966|NCT03286218|144738032|OTHER||LS Mean Difference|20.4|||||TWO_SIDED|90.0|13.6|27.2||||||Bad effects||27.2|13.6|
72604967|NCT03286218|144738032|OTHER||LS Mean Difference|5.04|||||TWO_SIDED|90.0|-1.76|11.8||||||Bad effects||11.8|-1.76|
72604968|NCT03286218|144738032|OTHER||LS Mean Difference|7.28|||||TWO_SIDED|90.0|0.487|14.1||||||Bad effects||14.1|0.487|
72604969|NCT03286218|144738032|OTHER||LS Mean Difference|12.5|||||TWO_SIDED|90.0|5.69|19.3||||||Bad effects||19.3|5.69|
72604970|NCT03286218|144738032|OTHER||LS Mean Difference|75.4|||||TWO_SIDED|90.0|67.2|83.5||||||Any effects||83.5|67.2|
72604971|NCT03286218|144738032|OTHER||LS Mean Difference|44.9|||||TWO_SIDED|90.0|36.8|53.0||||||Any effects||53.0|36.8|
72604972|NCT03286218|144738032|OTHER||LS Mean Difference|56.8|||||TWO_SIDED|90.0|48.7|64.9||||||Any effects||64.9|48.7|
72604973|NCT03286218|144738032|OTHER||LS Mean Difference|64.8|||||TWO_SIDED|90.0|56.7|73.0||||||Any effects||73.0|56.7|
72604974|NCT03286218|144738032|OTHER||LS Mean Difference|68.6|||||TWO_SIDED|90.0|60.6|76.6||||||High||76.6|60.6|
72604975|NCT03286218|144738032|OTHER||LS Mean Difference|34.4|||||TWO_SIDED|90.0|26.4|42.4||||||High||42.4|26.4|
72604976|NCT03286218|144738032|OTHER||LS Mean Difference|47.5|||||TWO_SIDED|90.0|39.5|55.5||||||High||55.5|39.5|
72604977|NCT03286218|144738032|OTHER||LS Mean Difference|58.4|||||TWO_SIDED|90.0|50.4|66.3||||||High||66.3|50.4|
72604978|NCT03286218|144738033|SUPERIORITY||Mean Difference (Final Values)|0.0|||<|0.0001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
72604979|NCT03286218|144738033|SUPERIORITY||Median Difference (Final Values)|0.0||||0.0781|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.0781
72604980|NCT03286218|144738033|SUPERIORITY||Median Difference (Final Values)|0.0||||0.0625|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.0625
72604981|NCT03286218|144738033|SUPERIORITY||Median Difference (Final Values)|0.0||||0.0098|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.0098
72604982|NCT03286218|144738034|OTHER||LS Mean Difference|-29.9|||||TWO_SIDED|90.0|-34.0|-25.9||||||Alertness/drowsiness||-25.9|-34.0|
72604983|NCT03286218|144738034|OTHER||LS Mean Difference|-16.9|||||TWO_SIDED|90.0|-20.9|-12.8||||||Alertness/drowsiness||-12.8|-20.9|
72604984|NCT03286218|144738034|OTHER||LS Mean Difference|-19.6|||||TWO_SIDED|90.0|-23.6|-15.5||||||Alertness/drowsiness||-15.5|-23.6|
72604985|NCT03286218|144738034|OTHER||LS Mean Difference|-24.8|||||TWO_SIDED|90.0|-28.8|-20.8||||||Alertness/drowsiness||-20.8|-28.8|
72604986|NCT03286218|144738034|OTHER||LS Mean Difference|-30.8|||||TWO_SIDED|90.0|-35.0|-26.5||||||Agitation/relaxation||-26.5|-35.0|
72604987|NCT03286218|144738034|OTHER||LS Mean Difference|-19.5|||||TWO_SIDED|90.0|-23.7|-15.3||||||Agitation/relaxation||-15.3|-23.7|
72604988|NCT03286218|144738034|OTHER||LS Mean Difference|-21.7|||||TWO_SIDED|90.0|-25.9|-17.5||||||Agitation/relaxation||-17.5|-25.9|
72604989|NCT03286218|144738034|OTHER||LS Mean Difference|-28.8|||||TWO_SIDED|90.0|-33.0|-24.5||||||Agitation/relaxation||-24.5|-33.0|
72604990|NCT02762084|144738041|OTHER|Pairwise comparison||||||0.03|||||||ANCOVA|ANCOVA with treatment group as a factor and Baseline value as a covariate||at Week 26||||0.030
72604991|NCT02762084|144738041|OTHER|Pairwise comparison||||||0.756|||||||ANCOVA|ANCOVA with treatment group as a factor and Baseline value as a covariate||at Week 26||||0.756
72604992|NCT02762084|144738042|OTHER|Pairwise comparison||||||0.5|||||||ANCOVA|ANCOVA with treatment group as a factor and using Baseline value as a covariate||at Week 6||||0.500
72604993|NCT02762084|144738042|OTHER|Pairwise comparison||||||0.681|||||||ANCOVA|ANCOVA with treatment group as a factor and using Baseline value as a covariate||at Week 6||||0.681
72604994|NCT02762084|144738046|OTHER|One-sided comparison||||||0.048|||||||Mann Whitey U|||at Week 26||||0.048
72604995|NCT02762084|144738046|OTHER|Two-sided comparison||||||0.096|||||||Mann Whitey U|||at Week 26||||0.096
72604996|NCT02762084|144738047|OTHER|Two-sided comparison||||||0.008|||||||Mann Whitey U|||at Week 26||||0.008
72604997|NCT03416270|144738068|OTHER|||||||0.36||||||12 weeks|Wilcoxon (Mann-Whitney)|||||||0.36
72604998|NCT03416270|144738068|OTHER|||||||0.56||||||1 week|Wilcoxon (Mann-Whitney)|||||||0.56
72604999|NCT03416270|144738069|OTHER|||||||0.303|||||||Wilcoxon (Mann-Whitney)|||||||0.303
72605000|NCT03416270|144738070|OTHER|||||||0.438|||||||Wilcoxon (Mann-Whitney)|||||||0.438
72605001|NCT03416270|144738071|OTHER|||||||0.599|||||||Wilcoxon (Mann-Whitney)|||||||0.599
72605002|NCT03416270|144738072|OTHER|||||||0.92|||||||Wilcoxon (Mann-Whitney)|||||||0.92
72605003|NCT03416270|144738073|OTHER|||||||0.405|||||||Wilcoxon (Mann-Whitney)|||||||0.405
72605004|NCT03416270|144738074|OTHER|||||||0.536|||||||Wilcoxon (Mann-Whitney)|||||||0.536
72605005|NCT03416270|144738075|OTHER|||||||0.443|||||||Wilcoxon (Mann-Whitney)|||||||0.443
72605006|NCT03416270|144738076|OTHER|||||||0.849|||||||Wilcoxon (Mann-Whitney)|||||||0.849
72605007|NCT03416270|144738077|OTHER|||||||0.013|||||||Wilcoxon (Mann-Whitney)|||||||0.013
72605008|NCT03416270|144738078|OTHER|||||||0.844|||||||Wilcoxon (Mann-Whitney)|||||||0.844
72605009|NCT03416270|144738079|OTHER|||||||0.262|||||||Wilcoxon (Mann-Whitney)|||||||0.262
72605010|NCT03416270|144738080|OTHER|||||||0.802|||||||Wilcoxon (Mann-Whitney)|||||||0.802
72605011|NCT03416270|144738081|OTHER|||||||0.327|||||||Wilcoxon (Mann-Whitney)|||||||0.327
72605012|NCT03416270|144738082|OTHER|||||||0.618|||||||Wilcoxon (Mann-Whitney)|||||||0.618
72605013|NCT03416270|144738083|OTHER|||||||0.946|||||||Wilcoxon (Mann-Whitney)|||||||0.946
72605014|NCT03416270|144738084|OTHER|||||||0.53||||||12 week|Wilcoxon (Mann-Whitney)|||||||0.53
72605015|NCT03416270|144738084|OTHER|||||||0.89||||||1 week|Wilcoxon (Mann-Whitney)|||||||0.89
72605016|NCT03416270|144738085|OTHER|||||||0.26||||||12 weeks|Wilcoxon (Mann-Whitney)|||||||0.26
72605017|NCT03416270|144738085|OTHER|||||||0.56||||||1 week|Wilcoxon (Mann-Whitney)|||||||0.56
72605018|NCT03257436|144738089|OTHER|"A power calculation using a sample size of 61 subjects as the non-responders with the LV MSP on was calculated based on a one-sided exact test for a single binomial proportion, using SAS Version 9.4 with the following assumptions:~* Performance goal = 90%~* Expected LV MSP feature-related CFR rate between 6 and 12 Month Visit = 98%~* Significance level = 5%~* Power = 80%"|Kaplan Meir Methodology|99.0|||||ONE_SIDED|95.0|94.1|||||||"The LV MSP feature-related CFR between the 6 Month Visit and the 12 Month Visit was calculated using Kaplan-Meier methodology.~H0: LV MSP feature-related complication-free rate between 6 Month Visit and 12 Month Visit ≤ 90%.~The sample size of 61 subjects was required to evaluate the Primary Safety Endpoint using an exact test since a power calculation cannot be directly calculated for a one group Kaplan-Meier analysis."|||94.1|
72605019|NCT03257436|144738090|OTHER|Even though fewer subjects (78) were available for the effectiveness endpoint analysis than originally planned (110), the study was still powered at approximately 90%|Proportion|51.3|||||ONE_SIDED|95.0|41.1|||||||"The effectiveness endpoint for SMART MSP PAS is the proportion of the LV MSP Group with an Improved CCS. For this endpoint, those subjects in the LV MSP Group that become responders will be defined as having an Improved CCS.~H0: Proportion of LV MSP Group subjects with Improved CCS from 6 Month Visit through 12 Month Visit ≤ 5%"|||41.1|
72605020|NCT01619852|144738091|SUPERIORITY_OR_OTHER_LEGACY|||||||0.19|||||||Wilcoxon (Mann-Whitney)|||||||.19
72605021|NCT01619852|144738092|SUPERIORITY_OR_OTHER_LEGACY|||||||0.64|||||||Wilcoxon (Mann-Whitney)|||||||0.64
72605022|NCT01619852|144738093|SUPERIORITY_OR_OTHER_LEGACY|||||||0.68|||||||Wilcoxon (Mann-Whitney)|||||||0.68
72605023|NCT01619852|144738093|SUPERIORITY_OR_OTHER_LEGACY|||||||0.69|||||||Wilcoxon (Mann-Whitney)|||McGill Questionnaire-Sensory-discriminative dimension||||0.69
72605024|NCT01619852|144738093|SUPERIORITY_OR_OTHER_LEGACY|||||||0.75|||||||Wilcoxon (Mann-Whitney)|||McGill Questionnaire-affective dimension||||0.75
72605025|NCT01619852|144738093|SUPERIORITY_OR_OTHER_LEGACY|||||||0.81|||||||Wilcoxon (Mann-Whitney)|||Brief Pain Inventory||||0.81
72605026|NCT01619852|144738094|SUPERIORITY_OR_OTHER_LEGACY|||||||0.19|||||||Wilcoxon (Mann-Whitney)|||||||.19
72605027|NCT01619852|144738095|SUPERIORITY_OR_OTHER_LEGACY|||||||0.29|||||||Wilcoxon (Mann-Whitney)|||||||.29
72605028|NCT03428100|144738096|SUPERIORITY||Odds Ratio (OR)|1.78||||0.071|TWO_SIDED|95.0|0.95|3.32|||Regression, Logistic|||||3.32|0.95|0.071
72605029|NCT03428100|144738096|SUPERIORITY||Odds Ratio (OR)|2.15||||0.031|TWO_SIDED|95.0|1.07|4.3|||Regression, Logistic|||||4.30|1.07|0.031
72605030|NCT03428100|144738097|SUPERIORITY||Odds Ratio (OR)|1.34||||0.427|TWO_SIDED|95.0|0.65|2.77|||Regression, Logistic|||||2.77|0.65|0.427
72605031|NCT03428100|144738098|SUPERIORITY||Odds Ratio (OR)|1.35||||0.513|TWO_SIDED|95.0|0.55|3.35|||Regression, Logistic|||||3.35|0.55|0.513
72605032|NCT03428100|144738098|SUPERIORITY||Odds Ratio (OR)|1.6||||0.242|TWO_SIDED|95.0|0.73|3.53|||Regression, Logistic|||||3.53|0.73|0.242
72605033|NCT03428100|144738098|SUPERIORITY||Odds Ratio (OR)|2.54||||0.03|TWO_SIDED|95.0|1.09|5.9|||Regression, Logistic|||||5.90|1.09|0.030
72605034|NCT03428100|144738099|SUPERIORITY||Odds Ratio (OR)|1.32||||0.611|TWO_SIDED|95.0|0.45|3.83|||Regression, Logistic|||||3.83|0.45|0.611
72605035|NCT03428100|144738099|SUPERIORITY||Odds Ratio (OR)|1.59||||0.325|TWO_SIDED|95.0|0.63|3.99|||Regression, Logistic|||||3.99|0.63|0.325
72605036|NCT03428100|144738099|SUPERIORITY||Odds Ratio (OR)|2.29||||0.1|TWO_SIDED|95.0|0.85|6.14|||Regression, Logistic|||||6.14|0.85|0.100
72605037|NCT03428100|144738100|SUPERIORITY||Mean Difference (Final Values)|-17.65|STANDARD_ERROR_OF_MEAN|5.627||0.002|TWO_SIDED|95.0|-28.71|-6.58|||Mixed Models Analysis|||||-6.58|-28.71|0.002
72605038|NCT03428100|144738100|SUPERIORITY||Mean Difference (Final Values)|-13.35|STANDARD_ERROR_OF_MEAN|4.82||0.006|TWO_SIDED|95.0|-22.83|-3.87|||Mixed Models Analysis|||||-3.87|-22.83|0.006
72605039|NCT03428100|144738100|SUPERIORITY||Mean Difference (Final Values)|-20.62|STANDARD_ERROR_OF_MEAN|5.554||0.0002|TWO_SIDED|95.0|-31.54|-9.7|||Mixed Models Analysis|||||-9.70|-31.54|0.0002
72605040|NCT03428100|144738101|SUPERIORITY||Odds Ratio (OR)|4.14||||0.115|TWO_SIDED|95.0|0.71|24.29|||Regression, Logistic|||||24.29|0.71|0.115
72416257|NCT01972841|144343307|SUPERIORITY||Standard Error of the Mean|-0.32|STANDARD_ERROR_OF_MEAN|0.11||0.019|TWO_SIDED|5.0|-0.54|-0.1|||Stratified rank ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (mirabegron 50mg ) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||-0.10|-0.54|0.019
72416258|NCT01972841|144343308|SUPERIORITY||Least squares mean difference|-0.33|STANDARD_ERROR_OF_MEAN|0.18||0.074|TWO_SIDED|95.0|-0.69|0.03|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (solifenacin 5 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||0.03|-0.69|0.074
72605041|NCT03428100|144738101|SUPERIORITY||Odds Ratio (OR)|5.85||||0.037|TWO_SIDED|95.0|1.11|30.88|||Regression, Logistic|||||30.88|1.11|0.037
72605042|NCT03428100|144738101|SUPERIORITY||Odds Ratio (OR)|4.78||||0.083|TWO_SIDED|95.0|0.81|28.08|||Regression, Logistic|||||28.08|0.81|0.083
72605043|NCT03428100|144738102|SUPERIORITY||Odds Ratio (OR)|3.28||||0.012|TWO_SIDED|95.0|1.29|8.32|||Regression, Logistic|||||8.32|1.29|0.012
72605044|NCT03428100|144738102|SUPERIORITY||Odds Ratio (OR)|3.71||||0.002|TWO_SIDED|95.0|1.59|8.66|||Regression, Logistic|||||8.66|1.59|0.002
72605045|NCT03428100|144738102|SUPERIORITY||Odds Ratio (OR)|6.85||||2e-05|TWO_SIDED|95.0|2.79|16.82|||Regression, Logistic|||||16.82|2.79|0.00002
72605046|NCT03428100|144738103|SUPERIORITY||Mean Difference (Final Values)|-0.42|STANDARD_ERROR_OF_MEAN|0.203||0.039|TWO_SIDED|95.0|-0.82|-0.02|||Mixed Models Analysis|||||-0.02|-0.82|0.039
72605047|NCT03428100|144738103|SUPERIORITY||Mean Difference (Final Values)|-0.21|STANDARD_ERROR_OF_MEAN|0.175||0.23|TWO_SIDED|95.0|-0.56|0.13|||Mixed Models Analysis|||||0.13|-0.56|0.23
72605048|NCT03428100|144738103|SUPERIORITY||Mean Difference (Final Values)|-0.79|STANDARD_ERROR_OF_MEAN|0.201||0.0001|TWO_SIDED|95.0|-1.18|-0.39|||Mixed Models Analysis|||||-0.39|-1.18|0.0001
72605049|NCT03428100|144738104|SUPERIORITY||Mean Difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|0.388||0.0714|TWO_SIDED|95.0|-1.47|0.06|||Mixed Models Analysis|||||0.06|-1.47|0.0714
72605050|NCT03428100|144738104|SUPERIORITY||Mean Difference (Final Values)|-0.84|STANDARD_ERROR_OF_MEAN|0.337||0.0134|TWO_SIDED|95.0|-1.5|-0.17|||Mixed Models Analysis|||||-0.17|-1.50|0.0134
72605051|NCT03428100|144738104|SUPERIORITY||Mean Difference (Final Values)|-1.45|STANDARD_ERROR_OF_MEAN|0.386||0.0002|TWO_SIDED|95.0|-2.21|-0.69|||Mixed Models Analysis|||||-0.69|-2.21|0.0002
72605052|NCT03428100|144738105|SUPERIORITY||Odds Ratio (OR)|1.71||||0.183|TWO_SIDED|95.0|0.78|3.75|||Regression, Logistic|||||3.75|0.78|0.183
72605053|NCT03428100|144738105|SUPERIORITY||Odds Ratio (OR)|1.54||||0.235|TWO_SIDED|95.0|0.76|3.11|||Regression, Logistic|||||3.11|0.76|0.235
72605054|NCT03428100|144738105|SUPERIORITY||Odds Ratio (OR)|1.01||||0.991|TWO_SIDED|95.0|0.43|2.36|||Regression, Logistic|||||2.36|0.43|0.991
72605055|NCT03428100|144738106|SUPERIORITY||Odds Ratio (OR)|1.41||||0.263|TWO_SIDED|95.0|0.77|2.57|||Regression, Logistic|||||2.57|0.77|0.263
72605056|NCT03428100|144738106|SUPERIORITY||Odds Ratio (OR)|1.89||||0.016|TWO_SIDED|95.0|1.13|3.19|||Regression, Logistic|||||3.19|1.13|0.016
72605057|NCT03428100|144738106|SUPERIORITY||Odds Ratio (OR)|1.93||||0.031|TWO_SIDED|95.0|1.06|3.52|||Regression, Logistic|||||3.52|1.06|0.031
72605058|NCT03428100|144738107|SUPERIORITY||Odds Ratio (OR)|1.97||||0.058|TWO_SIDED|95.0|0.98|3.96|||Regression, Logistic|||||3.96|0.98|0.058
72605059|NCT03428100|144738107|SUPERIORITY||Odds Ratio (OR)|1.77||||0.072|TWO_SIDED|95.0|0.95|3.32|||Regression, Logistic|||||3.32|0.95|0.072
72605060|NCT03428100|144738107|SUPERIORITY||Odds Ratio (OR)|1.56||||0.224|TWO_SIDED|95.0|0.76|3.18|||Regression, Logistic|||||3.18|0.76|0.224
72605061|NCT03428100|144738108|SUPERIORITY||Odds Ratio (OR)|5.03||||0.265|TWO_SIDED|95.0|0.29|86.08|||Regression, Logistic|||||86.08|0.29|0.265
72605062|NCT03428100|144738108|SUPERIORITY||Odds Ratio (OR)|2.54||||0.52|TWO_SIDED|95.0|0.15|43.09|||Regression, Logistic|||||43.09|0.15|0.520
72605063|NCT03428100|144738108|SUPERIORITY||Odds Ratio (OR)|7.17||||0.164|TWO_SIDED|95.0|0.45|99.99|||Regression, Logistic|||||99.99|0.45|0.164
72605064|NCT03428100|144738109|SUPERIORITY||Mean Difference (Final Values)|-6.08|STANDARD_ERROR_OF_MEAN|2.948||0.04|TWO_SIDED|95.0|-11.88|-0.29|||Mixed Models Analysis|||||-0.29|-11.88|0.040
72605065|NCT03428100|144738109|SUPERIORITY||Mean Difference (Final Values)|-6.56|STANDARD_ERROR_OF_MEAN|2.533||0.01|TWO_SIDED|95.0|-11.54|-1.58|||Mixed Models Analysis|||||-1.58|-11.54|0.010
72605066|NCT03428100|144738109|SUPERIORITY||Mean Difference (Final Values)|-9.77|STANDARD_ERROR_OF_MEAN|2.919|<|0.001|TWO_SIDED|95.0|-15.51|-4.03|||Mixed Models Analysis|||||-4.03|-15.51|<0.001
72605067|NCT03428100|144738110|SUPERIORITY||Odds Ratio (OR)|4.75||||0.265|TWO_SIDED|95.0|0.31|73.93|||Regression, Logistic|||||73.93|0.31|0.265
72605068|NCT03428100|144738110|SUPERIORITY||Odds Ratio (OR)|2.5||||0.511|TWO_SIDED|95.0|0.16|38.4|||Regression, Logistic|||||38.40|0.16|0.511
72605069|NCT03428100|144738110|SUPERIORITY||Odds Ratio (OR)|4.95||||0.253|TWO_SIDED|95.0|0.32|77.11|||Regression, Logistic|||||77.11|0.32|0.253
72605070|NCT03428100|144738111|SUPERIORITY||Mean Difference (Final Values)|-6.21|STANDARD_ERROR_OF_MEAN|3.078||0.044|TWO_SIDED|95.0|-12.26|-0.16|||Mixed Models Analysis|||||-0.16|-12.26|0.044
72605071|NCT03428100|144738111|SUPERIORITY||Mean Difference (Final Values)|-5.5|STANDARD_ERROR_OF_MEAN|2.632||0.037|TWO_SIDED|95.0|-10.67|-0.32|||Mixed Models Analysis|||||-0.32|-10.67|0.037
72605072|NCT03428100|144738111|SUPERIORITY||Mean Difference (Final Values)|-8.41|STANDARD_ERROR_OF_MEAN|3.03||0.006|TWO_SIDED|95.0|-14.37|-2.45|||Mixed Models Analysis|||||-2.45|-14.37|0.006
72605073|NCT03428100|144738112|SUPERIORITY||||||>|0.999|||||||Fisher Exact|||||||>.999
72605074|NCT03428100|144738112|SUPERIORITY|||||||0.797|||||||Fisher Exact|||||||0.797
72605075|NCT03428100|144738112|SUPERIORITY||||||>|0.999|||||||Fisher Exact|||||||>.999
72605076|NCT03428100|144738113|SUPERIORITY||Mean Difference (Final Values)|8.62|STANDARD_ERROR_OF_MEAN|4.49||0.056|TWO_SIDED|95.0|-0.22|17.45|||ANCOVA|||||17.45|-0.22|0.056
72605077|NCT03428100|144738113|SUPERIORITY||Mean Difference (Final Values)|5.48|STANDARD_ERROR_OF_MEAN|3.92||0.164|TWO_SIDED|95.0|-2.24|13.19|||ANCOVA|||||13.19|-2.24|0.164
72605078|NCT03428100|144738113|SUPERIORITY||Mean Difference (Final Values)|7.25|STANDARD_ERROR_OF_MEAN|4.53||0.11|TWO_SIDED|95.0|-1.66|16.15|||ANCOVA|||||16.15|-1.66|0.110
72605079|NCT03428100|144738114|SUPERIORITY||Mean Difference (Final Values)|-48.06|STANDARD_ERROR_OF_MEAN|35.63||0.178|TWO_SIDED|95.0|-118.0|21.88|||ANOVA|||||21.88|-118.00|0.178
72605080|NCT03428100|144738114|SUPERIORITY||Mean Difference (Final Values)|-56.9|STANDARD_ERROR_OF_MEAN|30.9||0.066|TWO_SIDED|95.0|-117.56|3.77|||ANOVA|||||3.77|-117.56|0.066
72605081|NCT03428100|144738114|SUPERIORITY||Mean Difference (Final Values)|-71.42|STANDARD_ERROR_OF_MEAN|35.57||0.045|TWO_SIDED|95.0|-141.24|-1.6|||ANOVA|||||-1.60|-141.24|0.045
72605082|NCT03428100|144738115|SUPERIORITY||Mean Difference (Final Values)|-11.32|STANDARD_ERROR_OF_MEAN|6.62||0.088|TWO_SIDED|95.0|-24.33|1.7|||Mixed Models Analysis|||||1.70|-24.33|0.088
72605083|NCT03428100|144738115|SUPERIORITY||Mean Difference (Final Values)|-15.41|STANDARD_ERROR_OF_MEAN|5.725||0.007|TWO_SIDED|95.0|-26.67|-4.16|||Mixed Models Analysis|||||-4.16|-26.67|0.007
72605084|NCT03428100|144738115|SUPERIORITY||Mean Difference (Final Values)|-19.76|STANDARD_ERROR_OF_MEAN|6.583||0.003|TWO_SIDED|95.0|-32.71|-6.82|||Mixed Models Analysis|||||-6.82|-32.71|0.003
72605085|NCT03428100|144738116|SUPERIORITY||Mean Difference (Final Values)|-14.0|STANDARD_ERROR_OF_MEAN|7.263||0.055|TWO_SIDED|95.0|-28.28|0.28|||Mixed Models Analysis|||||0.28|-28.28|0.055
72605086|NCT03428100|144738116|SUPERIORITY||Mean Difference (Final Values)|-14.76|STANDARD_ERROR_OF_MEAN|6.297||0.02|TWO_SIDED|95.0|-27.15|-2.38|||Mixed Models Analysis|||||-2.38|-27.15|0.020
72605087|NCT03428100|144738116|SUPERIORITY||Mean Difference (Final Values)|-17.82|STANDARD_ERROR_OF_MEAN|7.216||0.014|TWO_SIDED|95.0|-32.01|-3.62|||Mixed Models Analysis|||||-3.62|-32.01|0.014
72605088|NCT03428100|144738117|SUPERIORITY||Mean Difference (Final Values)|-2.06|STANDARD_ERROR_OF_MEAN|1.229||0.095|TWO_SIDED|95.0|-4.47|-0.36|||Mixed Models Analysis|||||-0.36|-4.47|0.095
72605089|NCT03428100|144738117|SUPERIORITY||Mean Difference (Final Values)|-3.09|STANDARD_ERROR_OF_MEAN|1.057||0.004|TWO_SIDED|95.0|-5.16|-1.01|||Mixed Models Analysis|||||-1.01|-5.16|0.004
72605090|NCT03428100|144738117|SUPERIORITY||Mean Difference (Final Values)|-5.09|STANDARD_ERROR_OF_MEAN|1.216|<|0.001|TWO_SIDED|95.0|-7.48|-2.7|||Mixed Models Analysis|||||-2.70|-7.48|<0.001
72605091|NCT03428100|144738118|SUPERIORITY||Mean Difference (Final Values)|-0.24|STANDARD_ERROR_OF_MEAN|0.146||0.097|TWO_SIDED|95.0|-0.53|0.04|||Mixed Models Analysis|||||0.04|-0.53|0.097
72605092|NCT03428100|144738118|SUPERIORITY||Mean Difference (Final Values)|-0.27|STANDARD_ERROR_OF_MEAN|0.126||0.033|TWO_SIDED|95.0|-0.52|-0.02|||Mixed Models Analysis|||||-0.02|-0.52|0.033
72605093|NCT03428100|144738118|SUPERIORITY||Mean Difference (Final Values)|-0.58|STANDARD_ERROR_OF_MEAN|0.145|<|0.001|TWO_SIDED|95.0|-0.86|-0.29|||Mixed Models Analysis|||||-0.29|-0.86|<0.001
72605094|NCT03428100|144738119|SUPERIORITY||Mean Difference (Final Values)|-0.57|STANDARD_ERROR_OF_MEAN|0.516||0.272|TWO_SIDED|95.0|-1.58|0.45|||Mixed Models Analysis|||Anxiety||0.45|-1.58|0.272
72605095|NCT03428100|144738119|SUPERIORITY||Mean Difference (Final Values)|-1.12|STANDARD_ERROR_OF_MEAN|0.446||0.013|TWO_SIDED|95.0|-1.99|-0.24|||Mixed Models Analysis|||Anxiety||-0.24|-1.99|0.013
72605096|NCT03428100|144738119|SUPERIORITY||Mean Difference (Final Values)|-0.85|STANDARD_ERROR_OF_MEAN|0.511||0.099|TWO_SIDED|95.0|-1.85|0.16|||Mixed Models Analysis|||Anxiety||0.16|-1.85|0.099
72605097|NCT03428100|144738119|SUPERIORITY||Mean Difference (Final Values)|-0.28|STANDARD_ERROR_OF_MEAN|0.519||0.584|TWO_SIDED|95.0|-1.3|0.74|||Mixed Models Analysis|||Depression||0.74|-1.30|0.584
72605098|NCT03428100|144738119|SUPERIORITY||Mean Difference (Final Values)|-0.63|STANDARD_ERROR_OF_MEAN|0.448||0.162|TWO_SIDED|95.0|-1.51|0.25|||Mixed Models Analysis|||Depression||0.25|-1.51|0.162
72605099|NCT03428100|144738119|SUPERIORITY||Mean Difference (Final Values)|-1.17|STANDARD_ERROR_OF_MEAN|0.515||0.024|TWO_SIDED|95.0|-2.18|-0.15|||Mixed Models Analysis|||Depression||-0.15|-2.18|0.024
72605100|NCT03428100|144738120|SUPERIORITY||Mean Difference (Final Values)|-1.23|STANDARD_ERROR_OF_MEAN|1.018||0.228|TWO_SIDED|95.0|-3.23|0.77|||Mixed Models Analysis|||||0.77|-3.23|0.228
72605101|NCT03428100|144738120|SUPERIORITY||Mean Difference (Final Values)|-1.62|STANDARD_ERROR_OF_MEAN|0.876||0.065|TWO_SIDED|95.0|-3.35|0.1|||Mixed Models Analysis|||||0.10|-3.35|0.065
72605102|NCT03428100|144738120|SUPERIORITY||Mean Difference (Final Values)|-3.01|STANDARD_ERROR_OF_MEAN|1.007||0.003|TWO_SIDED|95.0|-4.99|-1.02|||Mixed Models Analysis|||||-1.02|-4.99|0.003
72605103|NCT03428100|144738121|SUPERIORITY||Mean Difference (Final Values)|-0.92|STANDARD_ERROR_OF_MEAN|3.339||0.784|TWO_SIDED|95.0|-7.5|5.67|||Mixed Models Analysis|||Change from Baseline (CFB) Absenteeism||5.67|-7.50|0.784
72605104|NCT03428100|144738121|SUPERIORITY||Mean Difference (Final Values)|1.79|STANDARD_ERROR_OF_MEAN|2.813||0.525|TWO_SIDED|95.0|-3.75|7.34|||Mixed Models Analysis|||CFB Absenteeism||7.34|-3.75|0.525
72605105|NCT03428100|144738121|SUPERIORITY||Mean Difference (Final Values)|0.21|STANDARD_ERROR_OF_MEAN|3.204||0.947|TWO_SIDED|95.0|-6.11|6.53|||Mixed Models Analysis|||CFB Absenteeism||6.53|-6.11|0.947
72605106|NCT03428100|144738121|SUPERIORITY||Mean Difference (Final Values)|3.06|STANDARD_ERROR_OF_MEAN|4.409||0.488|TWO_SIDED|95.0|-5.62|11.74|||Mixed Models Analysis|||CFB Presenteeism||11.74|-5.62|0.488
72605107|NCT03428100|144738121|SUPERIORITY||Mean Difference (Final Values)|0.3|STANDARD_ERROR_OF_MEAN|3.72||0.936|TWO_SIDED|95.0|-7.02|7.62|||Mixed Models Analysis|||CFB Presenteeism||7.62|-7.02|0.936
72605108|NCT03428100|144738121|SUPERIORITY||Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|4.267||0.991|TWO_SIDED|95.0|-8.35|8.45|||Mixed Models Analysis|||CFB Presenteeism||8.45|-8.35|0.991
72605109|NCT03428100|144738121|SUPERIORITY||Mean Difference (Final Values)|1.15|STANDARD_ERROR_OF_MEAN|4.938||0.816|TWO_SIDED|95.0|-8.57|10.88|||Mixed Models Analysis|||CFB Work Productivity Loss||10.88|-8.57|0.816
72605110|NCT03428100|144738121|SUPERIORITY||Mean Difference (Final Values)|0.15|STANDARD_ERROR_OF_MEAN|4.178||0.971|TWO_SIDED|95.0|-8.08|8.38|||Mixed Models Analysis|||CFB Work Productivity Loss||8.38|-8.08|0.971
72605111|NCT03428100|144738121|SUPERIORITY||Mean Difference (Final Values)|-0.9|STANDARD_ERROR_OF_MEAN|4.804||0.852|TWO_SIDED|95.0|-10.36|8.56|||Mixed Models Analysis|||CFB Work Productivity Loss||8.56|-10.36|0.852
72605112|NCT03428100|144738121|SUPERIORITY||Mean Difference (Final Values)|-1.99|STANDARD_ERROR_OF_MEAN|3.877||0.607|TWO_SIDED|95.0|-9.61|5.63|||Mixed Models Analysis|||CFB Activity Impairment||5.63|-9.61|0.607
72605113|NCT03428100|144738121|SUPERIORITY||Mean Difference (Final Values)|-4.4|STANDARD_ERROR_OF_MEAN|3.319||0.186|TWO_SIDED|95.0|-10.92|2.12|||Mixed Models Analysis|||CFB Activity Impairment||2.12|-10.92|0.186
72605114|NCT03428100|144738121|SUPERIORITY||Mean Difference (Final Values)|-7.45|STANDARD_ERROR_OF_MEAN|3.82||0.052|TWO_SIDED|95.0|-14.96|0.06|||Mixed Models Analysis|||CFB Activity Impairment||0.06|-14.96|0.052
72605115|NCT03428100|144738122|SUPERIORITY||Mean Difference (Final Values)|0.03|STANDARD_ERROR_OF_MEAN|0.022||0.131|TWO_SIDED|95.0|-0.01|0.08|||Mixed Models Analysis|||CFB US Health State Index||0.08|-0.01|0.131
72605116|NCT03428100|144738122|SUPERIORITY||Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.019||0.017|TWO_SIDED|95.0|0.01|0.08|||Mixed Models Analysis|||CFB US Health State Index||0.08|0.01|0.017
72605117|NCT03428100|144738122|SUPERIORITY||Mean Difference (Final Values)|0.06|STANDARD_ERROR_OF_MEAN|0.022||0.003|TWO_SIDED|95.0|0.02|0.11|||Mixed Models Analysis|||CFB US Health State Index||0.11|0.02|0.003
72605118|NCT03428100|144738122|SUPERIORITY||Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.031||0.102|TWO_SIDED|95.0|-0.01|0.11|||Mixed Models Analysis|||CFB UK Health State Index||0.11|-0.01|0.102
72605119|NCT03428100|144738122|SUPERIORITY||Mean Difference (Final Values)|0.07|STANDARD_ERROR_OF_MEAN|0.027||0.014|TWO_SIDED|95.0|0.01|0.12|||Mixed Models Analysis|||CFB UK Health State Index||0.12|0.01|0.014
72605120|NCT03428100|144738122|SUPERIORITY||Mean Difference (Final Values)|0.09|STANDARD_ERROR_OF_MEAN|0.031||0.003|TWO_SIDED|95.0|0.03|0.15|||Mixed Models Analysis|||CFB UK Health State Index||0.15|0.03|0.003
72605121|NCT03428100|144738123|SUPERIORITY||Mean Difference (Final Values)|3.99|STANDARD_ERROR_OF_MEAN|3.256||0.221|TWO_SIDED|95.0|-2.41|10.39|||Mixed Models Analysis|||||10.39|-2.41|0.221
72605122|NCT03428100|144738123|SUPERIORITY||Mean Difference (Final Values)|1.12|STANDARD_ERROR_OF_MEAN|2.807||0.689|TWO_SIDED|95.0|-4.4|6.65|||Mixed Models Analysis|||||6.65|-4.40|0.689
72605123|NCT03428100|144738123|SUPERIORITY||Mean Difference (Final Values)|3.39|STANDARD_ERROR_OF_MEAN|3.226||0.294|TWO_SIDED|95.0|-2.95|9.74|||Mixed Models Analysis|||||9.74|-2.95|0.294
72605124|NCT03428100|144738124|SUPERIORITY||Odds Ratio (OR)|1.33||||0.382|TWO_SIDED|95.0|0.7|2.54|||Regression, Logistic|||||2.54|0.70|0.382
72605125|NCT03428100|144738124|SUPERIORITY||Odds Ratio (OR)|1.15||||0.638|TWO_SIDED|95.0|0.65|2.02|||Regression, Logistic|||||2.02|0.65|0.638
72605126|NCT03428100|144738124|SUPERIORITY||Odds Ratio (OR)|1.56||||0.169|TWO_SIDED|95.0|0.83|2.96|||Regression, Logistic|||||2.96|0.83|0.169
72605127|NCT03428100|144738125|SUPERIORITY||LS Mean Difference (Final Values)|-7.36|STANDARD_ERROR_OF_MEAN|9.674||0.447|TWO_SIDED|95.0|-26.38|11.66|||Regression, Linear|||||11.66|-26.38|0.447
72605128|NCT03428100|144738125|SUPERIORITY||LS Mean Difference (Final Values)|-3.88|STANDARD_ERROR_OF_MEAN|8.454||0.646|TWO_SIDED|95.0|-20.5|12.74|||Regression, Linear|||||12.74|-20.50|0.646
72605129|NCT03428100|144738125|SUPERIORITY||LS Mean Difference (Final Values)|-17.18|STANDARD_ERROR_OF_MEAN|9.64||0.075|TWO_SIDED|95.0|-36.14|1.77|||Regression, Linear|||||1.77|-36.14|0.075
72605130|NCT04556760|144738143|OTHER||Mean Difference (Final Values)|-132.9528||||0.036|TWO_SIDED|95.0|-256.5082|-9.3973|||Mixed Models Analysis|||Pairwise Comparisons with Prednisolone (AZD9567 72mg vs Prednisolone 40mg)||-9.3973|-256.5082|0.036
72605131|NCT04556760|144738143|OTHER||Mean Difference (Final Values)|-142.033||||0.432|TWO_SIDED|95.0|-554.8722|270.8061|||Mixed Models Analysis|||Pairwise Comparisons with Prednisolone (AZD9567 40mg vs Prednisolone 20mg)||270.8061|-554.8722|0.432
72605132|NCT04556760|144738143|OTHER||Mean Difference (Final Values)|-126.8829||||0.03|TWO_SIDED|95.0|-236.0426|-17.7233|||Mixed Models Analysis|||Pairwise Comparisons with Prednisolone (Placebo vs Prednisolone 5mg)||-17.7233|-236.0426|0.030
72605133|NCT04556760|144738144|OTHER||Mean Difference (Final Values)|-1.5067|||<|0.001|TWO_SIDED|95.0|-2.082|-0.9314|||Mixed Models Analysis|||Pairwise Comparisons with Prednisolone (AZD9567 72mg vs Prednisolone 40mg)||-0.9314|-2.0820|<0.001
72605134|NCT04556760|144738144|OTHER||Mean Difference (Final Values)|-1.1099|||<|0.001|TWO_SIDED|95.0|-1.7257|-0.4941|||Mixed Models Analysis|||Pairwise Comparisons with Prednisolone (AZD9567 40mg vs Prednisolone 20mg)||-0.4941|-1.7257|<0.001
72605135|NCT04556760|144738144|OTHER||Mean Difference (Final Values)|-0.1601||||0.547||95.0|-0.693|0.3729|||Mixed Models Analysis|||Pairwise Comparisons with Prednisolone (Placebo vs Prednisolone 5mg)||0.3729|-0.6930|0.547
72605136|NCT04556760|144738145|OTHER||Mean Difference (Final Values)|-1.5015|||<|0.001|TWO_SIDED|95.0|-2.2258|-0.7773|||Mixed Models Analysis|||Pairwise Comparisons with Prednisolone (AZD9567 72mg vs Prednisolone 40mg \[00 to 24 h\])||-0.7773|-2.2258|<0.001
72605137|NCT04556760|144738145|OTHER||Mean Difference (Final Values)|-1.8643|||<|0.001||95.0|-2.5611|-1.1674|||Mixed Models Analysis|||Pairwise Comparisons with Prednisolone (AZD9567 72mg vs Prednisolone 40mg \[24 to 48 h\])||-1.1674|-2.5611|<0.001
72605138|NCT04556760|144738145|OTHER||Mean Difference (Final Values)|-1.5998|||<|0.001|TWO_SIDED|95.0|-2.3025|-0.8971|||Mixed Models Analysis|||Pairwise Comparisons with Prednisolone (AZD9567 72mg vs Prednisolone 40mg \[48 to 72 h\])||-0.8971|-2.3025|<0.001
72605139|NCT04556760|144738145|OTHER||Mean Difference (Final Values)|-0.8474||||0.013|TWO_SIDED|95.0|-1.4465|-0.2484|||Mixed Models Analysis|||Pairwise Comparisons with Prednisolone (AZD9567 40mg vs Prednisolone 20mg \[00 to 24 h\])||-0.2484|-1.4465|0.013
72605140|NCT04556760|144738145|OTHER||Mean Difference (Final Values)|-0.7778||||0.061|TWO_SIDED|95.0|-1.6022|0.0466|||Mixed Models Analysis|||Pairwise Comparisons with Prednisolone (AZD9567 40mg vs Prednisolone 20mg \[24 to 48 h\])||0.0466|-1.6022|0.061
72605141|NCT04556760|144738145|OTHER||Mean Difference (Final Values)|-1.143||||0.003|TWO_SIDED|95.0|-1.7622|-0.5238|||Mixed Models Analysis|||Pairwise Comparisons with Prednisolone (AZD9567 40mg vs Prednisolone 20mg \[48 to 72 h\])||-0.5238|-1.7622|0.003
72605142|NCT04556760|144738145|OTHER||Mean Difference (Final Values)|-0.36||||0.125|TWO_SIDED|95.0|-0.8338|0.1138|||Mixed Models Analysis|||Pairwise Comparisons with Prednisolone (Placebo vs Prednisolone 5 mg \[00 to 24 h\])||0.1138|-0.8338|0.125
72605143|NCT04556760|144738145|OTHER||Mean Difference (Final Values)|-0.0845||||0.84|TWO_SIDED|95.0|-0.9706|0.8016|||Mixed Models Analysis|||Pairwise Comparisons with Prednisolone (Placebo vs Prednisolone 5 mg \[24 to 48 h\])||0.8016|-0.9706|0.840
72605144|NCT04556760|144738145|OTHER||Mean Difference (Final Values)|-0.1298||||0.571|TWO_SIDED|95.0|-0.646|0.3864|||Mixed Models Analysis|||Pairwise Comparisons with Prednisolone (Placebo vs Prednisolone 5 mg \[48 to 72 h\])||0.3864|-0.6460|0.571
72605145|NCT04556760|144738146|OTHER||Mean Difference (Final Values)|-0.07||||0.753|TWO_SIDED|95.0|-0.55|0.4|||Mixed Models Analysis|||Pairwise Comparisons with Prednisolone (AZD9567 72mg vs Prednisolone 40mg)||0.40|-0.55|0.753
72605146|NCT04556760|144738146|OTHER||Mean Difference (Final Values)|-0.04||||0.802|TWO_SIDED|95.0|-0.46|0.37|||Mixed Models Analysis|||Pairwise Comparisons with Prednisolone (AZD9567 40mg vs Prednisolone 20mg)||0.37|-0.46|0.802
72605147|NCT04556760|144738146|OTHER||Mean Difference (Final Values)|0.0||||0.985|TWO_SIDED|95.0|-0.37|0.37|||Mixed Models Analysis|||Pairwise Comparisons with Prednisolone (Placebo vs Prednisolone 5mg)||0.37|-0.37|0.985
72605148|NCT04556760|144738147|OTHER||Mean Difference (Final Values)|20498.7|||<|0.001|TWO_SIDED|95.0|10819.2|30178.2|||Mixed Models Analysis|||Pairwise Comparisons with Prednisolone (AZD9567 72mg vs Prednisolone 40mg)||30178.2|10819.2|<0.001
72605149|NCT04556760|144738147|OTHER||Mean Difference (Final Values)|3321.4||||0.659|TWO_SIDED|95.0|-12975.8|19618.6|||Mixed Models Analysis|||Pairwise Comparisons with Prednisolone (AZD9567 40mg vs Prednisolone 20mg)||19618.6|-12975.8|0.659
72605150|NCT04556760|144738147|OTHER||Mean Difference (Final Values)|-2698.8||||0.521|TWO_SIDED|95.0|-14849.0|9451.3|||Mixed Models Analysis|||Pairwise Comparisons with Prednisolone (Placebo vs Prednisolone 5mg)||9451.3|-14849.0|0.521
72605151|NCT04556760|144738148|OTHER||Mean Difference (Final Values)|-1002.5864||||0.003|TWO_SIDED|95.0|-1620.215|-384.9577|||Mixed Models Analysis|||Pairwise Comparisons with Prednisolone (AZD9567 72mg vs Prednisolone 40mg)||-384.9577|-1620.2150|0.003
72416259|NCT01972841|144343308|SUPERIORITY||Least squares mean difference|-0.45|STANDARD_ERROR_OF_MEAN|0.18||0.014|TWO_SIDED|95.0|-0.82|-0.09|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (solifenacin 5 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||-0.09|-0.82|0.014
72416260|NCT01972841|144343308|SUPERIORITY||Least squares mean difference|-0.65|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|95.0|-1.01|-0.28|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (mirabegron 25 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||-0.28|-1.01|<0.001
72605152|NCT04556760|144738148|OTHER||Mean Difference (Final Values)|40.9836||||0.865|TWO_SIDED|95.0|-526.6968|608.664|||Mixed Models Analysis|||Pairwise Comparisons with Prednisolone (AZD9567 40mg vs Prednisolone 20mg)||608.6640|-526.6968|0.865
72605153|NCT04556760|144738148|OTHER||Mean Difference (Final Values)|101.4137||||0.754|TWO_SIDED|95.0|-628.8097|831.637|||Mixed Models Analysis|||Pairwise Comparisons with Prednisolone (Placebo vs Prednisolone 5mg)||831.6370|-628.8097|0.754
72605154|NCT04556760|144738149|OTHER||Mean Difference (Final Values)|-1225.905||||0.004|TWO_SIDED|95.0|-2007.2241|-444.5859|||Mixed Models Analysis|||Pairwise Comparisons with Prednisolone (AZD9567 72mg vs Prednisolone 40mg)||-444.5859|-2007.2241|0.004
72605155|NCT04556760|144738149|OTHER||Mean Difference (Final Values)|-466.9802||||0.313|TWO_SIDED|95.0|-1521.5088|587.5485|||Mixed Models Analysis|||Pairwise Comparisons with Prednisolone (AZD9567 40mg vs Prednisolone 20mg)||587.5485|-1521.5088|0.313
72605156|NCT04556760|144738149|OTHER||Mean Difference (Final Values)|-375.3161||||0.404||95.0|-1433.6265|682.9943|||Mixed Models Analysis|||Pairwise Comparisons with Prednisolone (Placebo vs Prednisolone 5mg)||682.9943|-1433.6265|0.404
72605157|NCT04556760|144738150|OTHER||Mean Difference (Final Values)|365.6323||||0.608|TWO_SIDED|95.0|-1097.7973|1829.0618|||Mixed Models Analysis|||Pairwise Comparisons with Prednisolone (AZD9567 72mg vs Prednisolone 40mg)||1829.0618|-1097.7973|0.608
72605158|NCT04556760|144738150|OTHER||Mean Difference (Final Values)|188.236||||0.897|TWO_SIDED|95.0|-3214.3323|3590.8043|||Mixed Models Analysis|||Pairwise Comparisons with Prednisolone (AZD9567 40mg vs Prednisolone 20mg)||3590.8043|-3214.3323|0.897
72605159|NCT04556760|144738150|OTHER||Mean Difference (Final Values)|-1061.4494||||0.381||95.0|-3588.2233|1465.3244|||Mixed Models Analysis|||Pairwise Comparisons with Prednisolone (Placebo vs Prednisolone 5mg)||1465.3244|-3588.2233|0.381
72605160|NCT04556760|144738151|OTHER||Mean Difference (Final Values)|60.4211|||<|0.001||95.0|29.4904|91.3518|||Mixed Models Analysis|||Pairwise Comparisons with Prednisolone (AZD9567 72mg vs Prednisolone 40mg)||91.3518|29.4904|<0.001
72605161|NCT04556760|144738151|OTHER||Mean Difference (Final Values)|26.4529||||0.432||95.0|-44.9414|97.8471|||Mixed Models Analysis|||Pairwise Comparisons with Prednisolone (AZD9567 40mg vs Prednisolone 20mg)||97.8471|-44.9414|0.432
72605162|NCT04556760|144738151|OTHER||Mean Difference (Final Values)|-24.0243||||0.282||95.0|-74.0731|26.0245|||Mixed Models Analysis|||Pairwise Comparisons with Prednisolone (Placebo vs Prednisolone 5mg)||26.0245|-74.0731|0.282
72605163|NCT04556760|144738152|OTHER||Mean Difference (Final Values)|-0.6023||||0.531|TWO_SIDED|95.0|-2.5463|1.3416|||Mixed Models Analysis|||Pairwise Comparisons with Prednisolone (AZD9567 72mg vs Prednisolone 40mg)||1.3416|-2.5463|0.531
72605164|NCT04556760|144738152|OTHER||Mean Difference (Final Values)|0.4621||||0.682|TWO_SIDED|95.0|-2.0933|3.0176|||Mixed Models Analysis|||Pairwise Comparisons with Prednisolone (Placebo vs Prednisolone 5mg)||3.0176|-2.0933|0.682
72605165|NCT04556760|144738153|OTHER||Mean Difference (Final Values)|0.0679||||0.526||95.0|-0.152|0.2866|||Mixed Models Analysis|||Pairwise Comparisons with Prednisolone (AZD9567 72mg vs Prednisolone 40mg)||0.2866|-0.1520|0.526
72605166|NCT04556760|144738153|OTHER||Mean Difference (Final Values)|0.0882||||0.569||95.0|-0.2653|0.4416|||Mixed Models Analysis|||Pairwise Comparisons with Prednisolone (AZD9567 40mg vs Prednisolone 20mg||0.4416|-0.2653|0.569
72605167|NCT04556760|144738153|OTHER||Mean Difference (Final Values)|0.1257||||0.166|TWO_SIDED|95.0|-0.0677|0.3191|||Mixed Models Analysis|||Pairwise Comparisons with Prednisolone (Placebo vs Prednisolone 5mg)||0.3191|-0.0677|0.166
72605168|NCT04556760|144738154|OTHER||Mean Difference (Final Values)|0.01||||0.226|TWO_SIDED|95.0|-0.0072|0.0271|||Mixed Models Analysis|||Pairwise Comparisons with Prednisolone (AZD9567 72mg vs Prednisolone 40mg)||0.0271|-0.0072|0.226
72605169|NCT04556760|144738154|OTHER||Mean Difference (Final Values)|0.0033||||0.619||95.0|-0.0128|0.0195|||Mixed Models Analysis|||Pairwise Comparisons with Prednisolone (AZD9567 40mg vs Prednisolone 20mg)||0.0195|-0.0128|0.619
72605170|NCT04556760|144738154|OTHER||Mean Difference (Final Values)|0.0009||||0.917||95.0|-0.0189|0.0207|||Mixed Models Analysis|||Pairwise Comparisons with Prednisolone (Placebo vs Prednisolone 5mg)||0.0207|-0.0189|0.917
72605171|NCT04556760|144738155|OTHER||Mean Difference (Final Values)|0.0007||||0.357|TWO_SIDED|95.0|-0.0008|0.0022|||Mixed Models Analysis|||Pairwise Comparisons with Prednisolone (AZD9567 72mg vs Prednisolone 40mg)||0.0022|-0.0008|0.357
72605172|NCT04556760|144738155|OTHER||Mean Difference (Final Values)|0.0003||||0.676|TWO_SIDED|95.0|-0.0012|0.0017|||Mixed Models Analysis|||Pairwise Comparisons with Prednisolone (AZD9567 40mg vs Prednisolone 20mg)||0.0017|-0.0012|0.676
72605173|NCT04556760|144738155|OTHER||Mean Difference (Final Values)|0.0012||||0.096||95.0|-0.0002|0.0026|||Mixed Models Analysis|||Pairwise Comparisons with Prednisolone (Placebo vs Prednisolone 5mg)||0.0026|-0.0002|0.096
72605174|NCT04556760|144738156|OTHER||Mean Difference (Final Values)|-1.73||||0.646|TWO_SIDED|95.0|-9.4|5.95|||Mixed Models Analysis|||Pairwise Comparisons with Prednisolone (AZD9567 72mg vs Prednisolone 40mg)||5.95|-9.40|0.646
72605175|NCT04556760|144738156|OTHER||Mean Difference (Final Values)|-10.97||||0.11||95.0|-25.39|3.44|||Mixed Models Analysis|||Pairwise Comparisons with Prednisolone (AZD9567 40mg vs Prednisolone 20mg)||3.44|-25.39|0.110
72605176|NCT04556760|144738156|OTHER||Mean Difference (Final Values)|-0.35||||0.932||95.0|-10.32|9.61|||Mixed Models Analysis|||Pairwise Comparisons with Prednisolone (Placebo vs Prednisolone 5mg)||9.61|-10.32|0.932
72605177|NCT04556760|144738157|OTHER||Mean Difference (Final Values)|7.6||||0.533|TWO_SIDED|95.0|-17.4|32.7|||Mixed Models Analysis|||Pairwise Comparisons with Prednisolone (AZD9567 72mg vs Prednisolone 40mg)||32.7|-17.4|0.533
72605178|NCT04556760|144738157|OTHER||Mean Difference (Final Values)|22.3||||0.311||95.0|-26.7|71.3|||Mixed Models Analysis|||Pairwise Comparisons with Prednisolone (AZD9567 40mg vs Prednisolone 20mg)||71.3|-26.7|0.311
72605179|NCT04556760|144738157|OTHER||Mean Difference (Final Values)|31.0||||0.204||95.0|-21.9|83.9|||Mixed Models Analysis|||Pairwise Comparisons with Prednisolone (Placebo vs Prednisolone 5mg)||83.9|-21.9|0.204
72605180|NCT04556760|144738167|OTHER||Mean Difference (Final Values)|-4.0066||||0.103|TWO_SIDED|95.0|-8.888|0.8748|||Mixed Models Analysis|||Pairwise Comparisons with Prednisolone (AZD9567 72mg vs Prednisolone 40mg)||0.8748|-8.8880|0.103
72605181|NCT04556760|144738167|OTHER||Mean Difference (Final Values)|5.7535||||0.005||95.0|2.6034|8.9036|||Mixed Models Analysis|||Pairwise Comparisons with Prednisolone (AZD9567 40mg vs Prednisolone 20mg)||8.9036|2.6034|0.005
72605182|NCT04556760|144738167|OTHER||Mean Difference (Final Values)|9.0619||||0.023||95.0|1.674|16.4499|||Mixed Models Analysis|||Pairwise Comparisons with Prednisolone (Placebo vs Prednisolone 5mg)||16.4499|1.6740|0.023
72605183|NCT02168491|144738171|SUPERIORITY_OR_OTHER||||||<|0.02|||||||paired t test|||||||<0.02
72605184|NCT02168491|144738172|SUPERIORITY_OR_OTHER|||||||0.24|||||||paired t test|||||||0.24
72605185|NCT02168491|144738173|SUPERIORITY_OR_OTHER|||||||0.28|||||||paired t test|||||||0.28
72605186|NCT01096160|144738184|OTHER|Difference in change from baseline in SBP (TWA\^0-24hrs)|Mean Difference (Final Values)|-7.08||||0.1194|TWO_SIDED|90.0|-17.1|2.92|||Linear mixed effects model|||||2.92|-17.1|0.1194
72605187|NCT01096160|144738184|OTHER|Difference in change from baseline in SBP (TWA\^0-24hrs)|Mean Difference (Final Values)|-13.1||||0.0224|TWO_SIDED|90.0|-23.7|-2.48|||Linear mixed effects model|||||-2.48|-23.7|0.0224
72605188|NCT01096160|144738184|OTHER|Difference in change from baseline in SBP (TWA\^0-24hrs)|Mean Difference (Final Values)|0.33||||0.4791|TWO_SIDED|90.0|-10.3|10.91|||Linear mixed effects model|||||10.91|-10.3|0.4791
72605189|NCT01096160|144738184|OTHER|Difference in change from baseline in SBP (TWA\^0-24hrs)|Mean Difference (Final Values)|-8.21||||0.0705|TWO_SIDED|90.0|-17.4|1.01|||Linear mixed effcts model|||Panel D and Panel E had identical treatments (MK-8266 0.8 mg TID), which were combined for this analysis. Panel D was completed prior to initiation of Panel E.||1.01|-17.4|0.0705
72605190|NCT01096160|144738185|OTHER|Comparison of Day 10 values (TWA\^0-24hrs) for MK-8266 vs placebo|Mean Difference (Final Values)|3.85||||0.1161|TWO_SIDED|90.0|-1.51|9.22|||Linear mixed effects model|||||9.22|-1.51|0.1161
72605191|NCT01096160|144738185|OTHER|Comparison of Day 10 values (TWA\^0-24hrs) for MK-8266 vs placebo|Mean Difference (Final Values)|7.28||||0.0189|TWO_SIDED|90.0|1.6|12.97|||Linear mixed effects model|||||12.97|1.60|0.0189
72605192|NCT01096160|144738185|OTHER|Comparison of Day 10 values (TWA\^0-24hrs) for MK-8266 vs placebo|Mean Difference (Final Values)|0.26||||0.4689|TWO_SIDED|90.0|-5.42|5.95|||Linear mixed effects model|||||5.95|-5.42|0.4689
72605193|NCT01096160|144738185|OTHER|Comparison of Day 10 values (TWA\^0-24hrs) for MK-8266 vs placebo|Mean Difference (Final Values)|4.06||||0.0869|TWO_SIDED|90.0|-0.89|9.01|||Linear mixed effects model|||Panel D and Panel E had identical treatments (MK-8266 0.8 mg TID), which were combined for this analysis. Panel D was completed prior to initiation of Panel E.||9.01|-0.89|0.0869
72605194|NCT01096160|144738186|OTHER|Comparison of Day 10 values (TWA\^0-24hrs) for MK-8266 vs placebo|Mean Difference (Final Values)|-9.87||||0.003|TWO_SIDED|90.0|-15.7|-4.09|||Linear mixed effects model|||||-4.09|-15.7|0.003
72605195|NCT01096160|144738186|OTHER|Comparison of Day 10 values (TWA\^0-24hrs) for MK-8266 vs placebo|Mean Difference (Final Values)|-11.2||||0.002|TWO_SIDED|90.0|-17.3|-5.1|||Linear mixed effects model|||||-5.10|-17.3|0.002
72605196|NCT01096160|144738186|OTHER|Comparison of Day 10 values (TWA\^0-24hrs) for MK-8266 vs placebo|Mean Difference (Final Values)|-5.18||||0.08|TWO_SIDED|90.0|-11.3|0.95|||Linear mixed effcts model|||||0.95|-11.3|0.080
72605197|NCT01096160|144738186|OTHER|Difference in change from baseline in AIx (TWA\^0-24hrs)|Mean Difference (Final Values)|-6.79||||0.019|TWO_SIDED|90.0|-12.1|-1.46|||Linear mixed effcts model|||Panel D and Panel E had identical treatments (MK-8266 0.8 mg TID), which were combined for this analysis. Panel D was completed prior to initiation of Panel E.||-1.46|-12.1|0.019
72605198|NCT01096160|144738187|OTHER|Difference in change from baseline in cGMP|Geometric Mean Ratio|1.28||||0.318|TWO_SIDED|90.0|0.53|3.05|||Linear mixed effects model|||||3.05|0.53|0.318
72605199|NCT01096160|144738187|OTHER|Difference in change from baseline in cGMP|Geometric Mean Ratio|1.66||||0.17|TWO_SIDED|90.0|0.66|4.17|||Linear mixed effects model|||||4.17|0.66|0.17
72605200|NCT01096160|144738187|OTHER|Difference in change from baseline in cGMP|Geometric Mean Ratio|0.41||||0.054|TWO_SIDED|90.0|0.16|1.02|||Linear mixed effcts model|||||1.02|0.16|0.054
72605201|NCT01096160|144738187|OTHER|Difference in change from baseline in cGMP|Geometric Mean Ratio|0.78||||0.297|TWO_SIDED|90.0|0.35|1.73|||Linear mixed effcts model|||Panel D and Panel E had identical treatments (MK-8266 0.8 mg TID), which were combined for this analysis. Panel D was completed prior to initiation of Panel E.||1.73|0.35|0.297
72605202|NCT00705757|144738211|SUPERIORITY_OR_OTHER|||||||0.769|TWO_SIDED||||||ANOVA|||One way ANOVA of Upper Lid||||0.769
72605203|NCT00705757|144738211|SUPERIORITY_OR_OTHER|||||||0.23|TWO_SIDED|95.0|||||ANOVA|||One way ANOVA of Lower Lid||||0.230
72605204|NCT00705757|144738211|SUPERIORITY_OR_OTHER|||||||0.851|TWO_SIDED|95.0|||||ANOVA|||One way ANOVA of cheek/face||||0.851
72605205|NCT01411852|144738213|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.39|||||TWO_SIDED|95.0|0.12|1.25|||||Adjusted for age (linear spline with knot at 45 years), penetrating vs. blunt or no trauma (1 patient had neither blunt nor penetrating trauma), and Injury Severity Score (ISS). ISS multiply imputed for one patient.|||1.25|0.12|
72605206|NCT01411852|144738214|SUPERIORITY_OR_OTHER||percent difference|-16.0|||||TWO_SIDED|95.0|-26.5|-5.5||||||||-5.5|-26.5|
72605207|NCT01411852|144738215|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.18|||||TWO_SIDED|95.0|-2.76|0.4||||||||0.40|-2.76|
72605208|NCT01411852|144738216|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.77|||||TWO_SIDED|95.0|-1.61|0.08||||||||0.08|-1.61|
72605209|NCT01411852|144738217|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2|||||TWO_SIDED|95.0|-1.8|2.2||||||||2.2|-1.8|
72605210|NCT01411852|144738218|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.4|||||TWO_SIDED|95.0|-0.3|1.0||||||||1.0|-0.3|
72605211|NCT01411852|144738219|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-20.4|||||TWO_SIDED|95.0|-42.5|1.6||||||||1.6|-42.5|
72605212|NCT01411852|144738220|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.02|||||TWO_SIDED|95.0|-0.06|0.1||||||||0.10|-0.06|
72605213|NCT01411852|144738221|SUPERIORITY_OR_OTHER||percent difference|-10.2|||||TWO_SIDED|95.0|-22.4|2.0||||||||2.0|-22.4|
72605214|NCT01411852|144738222|SUPERIORITY_OR_OTHER||percent difference|-18.9|||||TWO_SIDED|95.0|-39.2|1.4||||||||1.4|-39.2|
72605215|NCT01411852|144738223|SUPERIORITY_OR_OTHER||percent difference|-10.4|||||TWO_SIDED|95.0|-29.6|8.8||||||||8.8|-29.6|
72605216|NCT01411852|144738224|SUPERIORITY_OR_OTHER||percent difference|-4.4|||||TWO_SIDED|95.0|-16.6|7.8||||||||7.8|-16.6|
72605217|NCT01411852|144738225|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9|||||TWO_SIDED|95.0|-3.8|2.1||||||||2.1|-3.8|
72605218|NCT01411852|144738226|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6|||||TWO_SIDED|95.0|-3.6|2.4||||||||2.4|-3.6|
72605219|NCT01411852|144738227|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1|||||TWO_SIDED|95.0|-2.9|3.1||||||||3.1|-2.9|
72605220|NCT01411852|144738228|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.17|||||TWO_SIDED|95.0|0.03|0.92|||||Adjusted for age (linear spline with knot at 45 years) and Injury Severity Score (ISS). ISS multiply imputed for one patient.|||0.92|0.03|
72605221|NCT01411852|144738229|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.92|||||TWO_SIDED|95.0|0.19|19.11|||||Adjusted for age (linear spline with knot at 45 years) and Injury Severity Score (ISS).|||19.11|0.19|
72605222|NCT01411852|144738230|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.62|||||TWO_SIDED|95.0|0.22|1.77|||||Adjusted for age (linear spline with knot at 45 years), penetrating mechanism (yes/no), and ISS (linear).|||1.77|0.22|
72605223|NCT03193047|144738231|SUPERIORITY||Least squares mean difference|-30.261|STANDARD_ERROR_OF_MEAN|5.502|<|0.001|TWO_SIDED|95.0|-41.324|-19.199|||ANCOVA||(Bempedoic acid plus evolocumab) minus (placebo plus evolocumab)|||-19.199|-41.324|<0.001
72605224|NCT03193047|144738232|SUPERIORITY||Lease squares mean difference|-35.884|STANDARD_ERROR_OF_MEAN|5.159|<|0.001|TWO_SIDED|95.0|-46.303|-25.466|||ANCOVA||(Bempedoic acid plus evolocumab) minus (placebo plus evolocumab)|||-25.466|-46.303|<0.001
72605225|NCT03193047|144738233|SUPERIORITY||Least squares mean difference|-38.25|STANDARD_ERROR_OF_MEAN|5.602|<|0.001|TWO_SIDED|95.0|-49.558|-26.944|||ANCOVA||(Bempedoic acid plus evolocumab) minus (placebo plus evolocumab)|Month 1||-26.944|-49.558|<0.001
72605226|NCT03193047|144738233|SUPERIORITY||Least squares mean difference|-29.9|STANDARD_ERROR_OF_MEAN|5.606|<|0.001|TWO_SIDED|95.0|-41.176|-18.626|||ANCOVA||(Bempedoic acid plus evolocumab) minus (placebo plus evolocumab)|Month 2||-18.626|-41.176|<0.001
72416261|NCT01972841|144343308|SUPERIORITY||Least squares mean difference|-0.87|STANDARD_ERROR_OF_MEAN|0.19|<|0.001|TWO_SIDED|95.0|-1.24|0.51|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (mirabegron 50 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||0.51|-1.24|<0.001
72605227|NCT03193047|144738234|SUPERIORITY||Least squares mean difference|-27.031|STANDARD_ERROR_OF_MEAN|5.15|<|0.001|TWO_SIDED|95.0|-37.509|-16.553|||ANCOVA||(Bempedoic acid plus evolocumab) minus (placebo plus evolocumab)|Apo B at Month 1||-16.553|-37.509|<0.001
72605228|NCT03193047|144738234|SUPERIORITY||Least squares mean difference|-24.469|STANDARD_ERROR_OF_MEAN|4.33|<|0.001|TWO_SIDED|95.0|-33.225|-15.713|||ANCOVA||(Bempedoic acid plus evolocumab) minus (placebo plus evolocumab)|Apo B at Month 2||-15.713|-33.225|<0.001
72605229|NCT03193047|144738234|SUPERIORITY||Least squares mean difference|-31.64|STANDARD_ERROR_OF_MEAN|4.689|<|0.001|TWO_SIDED|95.0|-41.116|-22.163|||ANCOVA||(Bempedoic acid plus evolocumab) minus (placebo plus evolocumab)|non-HDL-C at Month 1||-22.163|-41.116|<0.001
72605230|NCT03193047|144738234|SUPERIORITY||Least squares mean difference|-24.246|STANDARD_ERROR_OF_MEAN|4.838|<|0.001|TWO_SIDED|95.0|-33.987|-14.505|||ANCOVA||(Bempedoic acid plus evolocumab) minus (placebo plus evolocumab)|non-HDL-C at Month 2||-14.505|-33.987|<0.001
72605231|NCT03193047|144738234|SUPERIORITY||Least squares mean difference|-21.941|STANDARD_ERROR_OF_MEAN|3.572|<|0.001|TWO_SIDED|95.0|-29.153|-14.729|||ANCOVA||(Bempedoic acid plus evolocumab) minus (placebo plus evolocumab)|TC at Month 1||-14.729|-29.153|<0.001
72605232|NCT03193047|144738234|SUPERIORITY||Least squares mean difference|-17.52|STANDARD_ERROR_OF_MEAN|3.809|<|0.001|TWO_SIDED|95.0|-25.201|-9.839|||ANCOVA||(Bempedoic acid plus evolocumab) minus (placebo plus evolocumab)|TC at Month 2||-9.839|-25.201|<0.001
72605233|NCT03193047|144738235|SUPERIORITY||Median treatment difference|-32.479|STANDARD_ERROR_OF_MEAN|17.395||0.046|TWO_SIDED|95.0|-70.524|-2.339|||Wilcoxon rank sum test||The median treatment difference (location shift) and the 95% confidence limits are from Hodges-Lehmann estimates.|hs-CRP at Month 1||-2.339|-70.524|0.046
72605234|NCT03193047|144738235|SUPERIORITY||Median treatment difference|-28.512|STANDARD_ERROR_OF_MEAN|12.124||0.029|TWO_SIDED|95.0|-51.455|-3.93|||Wilcoxon rank sum test||The median treatment difference (location shift) and the 95% confidence limits are from Hodges-Lehmann estimates.|hs-CRP at Month 2||-3.930|-51.455|0.029
72605235|NCT00186485|144738276|SUPERIORITY_OR_OTHER||||||<|0.001||||||Repeated Measures ANOVAs over the course of the TMS treatments, by severity of depression on the HAM-D rating scale: total scores (F (4,96) = 19.88, p \< .001) over the 4 week treatment period.|ANOVA|Repeated Measures Anova||ANOVA with partial eta accounts for multiple repeated measures over the course of treatment.||||<0.001
72605236|NCT00186485|144738277|SUPERIORITY_OR_OTHER||||||<|0.01||||||Repeated Measures ANOVAs over the course of the TMS treatments, by severity of depression on the BDI total scores (F (4,96) = 19.35, p \< .001) over the 4 week treatment period.,|ANOVA|||Repeated measures ANOVA with partial eta; accounts for multiple repeated measures over the course of treatment.||||<0.01
72605237|NCT00186485|144738278|SUPERIORITY_OR_OTHER||||||<|0.01||||||Repeated Measures ANOVAs over the course of the TMS treatments, by severity of depression on the CGI scores (F (4,88) = 5.31, p \< .01) over the 4 week treatment period.|ANOVA|||Repeated Measures ANOVA with partial eta; p value was adjusted for multiple comparisons over the course of treatment||||<0.01
72605238|NCT02256839|144738289|EQUIVALENCE|A 2x2 contingency table with 95% CI.|2 x 2 contingency table|98.1|||||TWO_SIDED|95.0|95.3|99.3||||||||99.3|95.3|
72605239|NCT02256839|144738289|EQUIVALENCE|A 2x2 contingency table with 95% CI|2 x 2 contingency table|96.1|||||TWO_SIDED|95.0|85.4|99.3||||||||99.3|85.4|
72605240|NCT00121719|144738306|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0146|||||||Wilcoxon signed-rank test|||This was a pilot study and a statistical sample size calculation was not performed.||||0.0146
72605241|NCT02465164|144738333|OTHER|Wilcoxon rank-sum tests||||||0.208|||||||Wilcoxon (Mann-Whitney)|||||||0.208
72605242|NCT01481558|144738338|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.1|STANDARD_DEVIATION|0.01||0.55|TWO_SIDED|95.0|||||ANCOVA|||||||0.55
72605243|NCT01401543|144738352|NON_INFERIORITY_OR_EQUIVALENCE|AUC(0-∞) was log-transformed and analyzed using a linear mixed effects model with fixed factor for formulation, sequence, and period, and random factor for participant.|Geometric Least Squares (LS) Mean Ratio|0.96|||||TWO_SIDED|90.0|0.91|1.01|||||Formulation, sequence, and period were included in the model as fixed effects, and participant as a random factor.|||1.01|0.91|
72605244|NCT01401543|144738352|NON_INFERIORITY_OR_EQUIVALENCE|AUC(0-∞) was log-transformed and analyzed using a linear mixed effects model with fixed factor for formulation, sequence, and period, and random factor for participant.|Geometric LS Mean Ratio|0.89|||||TWO_SIDED|90.0|0.85|0.93|||||Formulation, sequence, and period were included in the model as fixed effects, and participant as a random factor.|||0.93|0.85|
72605245|NCT01401543|144738352|NON_INFERIORITY_OR_EQUIVALENCE|AUC(0-∞) was log-transformed and analyzed using a linear mixed effects model with fixed factor for formulation, sequence, and period, and random factor for participant.|Geometric LS Mean Ratio|0.93|||||TWO_SIDED|90.0|0.88|0.97|||||Formulation, sequence, and period were included in the model as fixed effects, and participant as a random factor.|||0.97|0.88|
72605246|NCT01401543|144738352|NON_INFERIORITY_OR_EQUIVALENCE|AUC(0-∞) was log-transformed and analyzed using a linear mixed effects model with fixed factor for formulation, sequence, and period, and random factor for participant.|Geometric LS Mean Ratio|0.9|||||TWO_SIDED|90.0|0.86|0.95|||||Formulation, sequence, and period were included in the model as fixed effects, and participant as a random factor.|||0.95|0.86|
72605247|NCT01401543|144738352|NON_INFERIORITY_OR_EQUIVALENCE|AUC(0-∞) was log-transformed and analyzed using a linear mixed effects model with fixed factor for formulation, sequence, and period, and random factor for participant.|Geometric LS Mean Ratio|0.94|||||TWO_SIDED|90.0|0.9|0.99|||||Formulation, sequence, and period were included in the model as fixed effects, and participant as a random factor.|||0.99|0.90|
72605248|NCT01401543|144738352|NON_INFERIORITY_OR_EQUIVALENCE|AUC(0-∞) was log-transformed and analyzed using a linear mixed effects model with fixed factor for formulation, sequence, and period, and random factor for participant.|Geometric LS Mean Ratio|1.02|||||TWO_SIDED|90.0|0.97|1.07|||||Formulation, sequence, and period were included in the model as fixed effects, and participant as a random factor.|||1.07|0.97|
72605249|NCT01401543|144738353|NON_INFERIORITY_OR_EQUIVALENCE|Cmax was log-transformed and analyzed using a linear mixed effects model with fixed factor for formulation, sequence, and period, and random factor for participant.|Geometric LS Mean Ratio|0.84|||||TWO_SIDED|90.0|0.77|0.91|||||Formulation, sequence, and period were included in the model as fixed effects, and participant as a random factor.|||0.91|0.77|
72605250|NCT01401543|144738353|NON_INFERIORITY_OR_EQUIVALENCE|Cmax was log-transformed and analyzed using a linear mixed effects model with fixed factor for formulation, sequence, and period, and random factor for participant.|Geometric LS Mean Ratio|0.78|||||TWO_SIDED|90.0|0.71|0.85|||||Formulation, sequence, and period were included in the model as fixed effects, and participant as a random factor.|||0.85|0.71|
72605251|NCT01401543|144738353|NON_INFERIORITY_OR_EQUIVALENCE|Cmax was log-transformed and analyzed using a linear mixed effects model with fixed factor for formulation, sequence, and period, and random factor for participant.|Geometric LS Mean Ratio|0.93|||||TWO_SIDED|90.0|0.85|1.01|||||Formulation, sequence, and period were included in the model as fixed effects, and participant as a random factor.|||1.01|0.85|
72605252|NCT01401543|144738353|NON_INFERIORITY_OR_EQUIVALENCE|Cmax was log-transformed and analyzed using a linear mixed effects model with fixed factor for formulation, sequence, and period, and random factor for participant.|Geometric LS Mean Ratio|0.77|||||TWO_SIDED|90.0|0.7|0.84|||||Formulation, sequence, and period were included in the model as fixed effects, and participant as a random factor.|||0.84|0.70|
72605253|NCT01401543|144738353|NON_INFERIORITY_OR_EQUIVALENCE|Cmax was log-transformed and analyzed using a linear mixed effects model with fixed factor for formulation, sequence, and period, and random factor for participant.|Geometric LS Mean Ratio|0.91|||||TWO_SIDED|90.0|0.84|1.0|||||Formulation, sequence, and period were included in the model as fixed effects, and participant as a random factor.|||1.00|0.84|
72605254|NCT01401543|144738353|NON_INFERIORITY_OR_EQUIVALENCE|Cmax was log-transformed and analyzed using a linear mixed effects model with fixed factor for formulation, sequence, and period, and random factor for participant.|Geometric LS Mean Ratio|0.99|||||TWO_SIDED|90.0|0.91|1.08|||||Formulation, sequence, and period were included in the model as fixed effects, and participant as a random factor.|||1.08|0.91|
72605255|NCT01401543|144738354|SUPERIORITY_OR_OTHER||Geometric LS Mean Ratio|0.99|||||TWO_SIDED|90.0|0.93|1.05||||||||1.05|0.93|
72605256|NCT01401543|144738354|SUPERIORITY_OR_OTHER||Geometric LS Mean Ratio|0.94|||||TWO_SIDED|90.0|0.89|1.0||||||||1.00|0.89|
72605257|NCT01401543|144738354|SUPERIORITY_OR_OTHER||Geometric LS Mean Ratio|0.96|||||TWO_SIDED|90.0|0.9|1.02||||||||1.02|0.90|
72605258|NCT01401543|144738354|SUPERIORITY_OR_OTHER||Geometric LS Mean Ratio|0.96|||||TWO_SIDED|90.0|0.9|1.02||||||||1.02|0.90|
72605259|NCT01401543|144738354|SUPERIORITY_OR_OTHER||Geometric LS Mean Ratio|0.97|||||TWO_SIDED|90.0|0.91|1.03||||||||1.03|0.91|
72605260|NCT01401543|144738354|SUPERIORITY_OR_OTHER||Geometric LS Mean Ratio|1.01|||||TWO_SIDED|90.0|0.95|1.08||||||||1.08|0.95|
72605261|NCT01401543|144738355|SUPERIORITY_OR_OTHER||Geometric LS Mean Ratio|0.72|||||TWO_SIDED|90.0|0.68|0.77|||||Formulation, sequence, and period were included in the model as fixed effects, and participant as a random factor.|||0.77|0.68|
72605262|NCT01401543|144738355|SUPERIORITY_OR_OTHER||Geometric LS Mean Ratio|0.71|||||TWO_SIDED|90.0|0.66|0.76|||||Formulation, sequence, and period were included in the model as fixed effects, and participant as a random factor.|||0.76|0.66|
72605263|NCT01401543|144738355|SUPERIORITY_OR_OTHER||Geometric LS Mean Ratio|0.98|||||TWO_SIDED|90.0|0.92|1.05|||||Formulation, sequence, and period were included in the model as fixed effects, and participant as a random factor.|||1.05|0.92|
72605264|NCT01401543|144738355|SUPERIORITY_OR_OTHER||Geometric LS Mean Ratio|0.69|||||TWO_SIDED|90.0|0.65|0.74|||||Formulation, sequence, and period were included in the model as fixed effects, and participant as a random factor.|||0.74|0.65|
72605265|NCT01401543|144738355|SUPERIORITY_OR_OTHER||Geometric LS Mean Ratio|0.96|||||TWO_SIDED|90.0|0.9|1.02|||||Formulation, sequence, and period were included in the model as fixed effects, and participant as a random factor.|||1.02|0.90|
72605266|NCT01401543|144738355|SUPERIORITY_OR_OTHER||Geometric LS Mean Ratio|0.98|||||TWO_SIDED|90.0|0.91|1.04|||||Formulation, sequence, and period were included in the model as fixed effects, and participant as a random factor.|||1.04|0.91|
72605267|NCT02359110|144738422|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.89|TWO_SIDED|95.0|-1.2|1.3|||Mixed Models Analysis|||Hour 2 Analysis||1.3|-1.2|0.89
72605268|NCT02359110|144738422|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.94|TWO_SIDED|95.0|-1.6|1.5|||Mixed Models Analysis|||Hour 4 Analysis||1.5|-1.6|0.94
72605269|NCT02359110|144738422|SUPERIORITY||Mean Difference (Final Values)|-0.4||||0.64|TWO_SIDED|95.0|-2.2|1.3|||Mixed Models Analysis|||Hour 6 Analysis||1.3|-2.2|0.64
72605270|NCT02359110|144738422|SUPERIORITY||Mean Difference (Final Values)|0.6||||0.59|TWO_SIDED|95.0|-1.6|2.8|||Mixed Models Analysis|||Hour 8 Analysis||2.8|-1.6|0.59
72605271|NCT02359110|144738423|SUPERIORITY||Mean Difference (Final Values)|3.8||||0.52|TWO_SIDED|95.0|-8.1|15.8|||Mixed Models Analysis|||Hour 2 Analysis||15.8|-8.1|0.52
72605272|NCT02359110|144738423|SUPERIORITY||Mean Difference (Final Values)|1.7||||0.8|TWO_SIDED|95.0|-11.9|15.3|||Mixed Models Analysis|||Hour 6 Analysis||15.3|-11.9|0.80
72605273|NCT02359110|144738424|SUPERIORITY|||||||0.88|||||||t-test, 2 sided|||||||0.88
72605274|NCT00823134|144738429|OTHER||Mean Difference (Final Values)|2.8|STANDARD_DEVIATION|4.7||0.021|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.021
72605275|NCT00823134|144738430|OTHER|The number of events found per category (PSG and ApneaLink Plus recording) will be compared. Events are Apneas and Hypopneas per hour of sleep, measured as Apnea-Hypopnea-Index (AHI), Apnea-Index (AI), Obstructive AI, Central AI, Hypopnea-Index (HI) and Oxygen Desaturation Index (ODI).|Correlation coefficient (Bland-Altman)|0.75|||||TWO_SIDED|||||||||Per recording, the number of events found per category with PSG and ApneaLink Plus will be compared. As a summary, all PSG values and all ApneaLink Plus values per category will be collected in one graph (Bland-Altmann Plot). The correlation coefficient will be calculated per category. A correlation of \>75% will be seen as threshold for validity.||||
72605276|NCT01519817|144738453|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.5221||||||The reported p-value is representative of the changes in levels of all CD4 cells at dose levels 1, 3, and 4. We could not do dose level 2 as we only had data on 2 patients and need an n\>2 to do paired analyses.|Wilcoxon test|||||||0.5221
72605277|NCT01519817|144738453|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.25||||||The reported p-value is representative of the changes in levels of CD4 cells at dose level 1.|Wilcoxon test|||||||0.25
72605278|NCT01519817|144738453|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.5||||||The reported p-value is representative of the changes in levels of CD4 cells at dose level 3.|Wilcoxon test|||||||0.50
72605279|NCT01519817|144738453|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.16||||||The reported p-value is representative of the changes in levels of CD4 cells at dose level 4.|Wilcoxon test|||||||0.16
72605280|NCT01519817|144738453|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.8665||||||The reported p-value is representative of the changes in levels of all CD8 cells at dose levels 1, 3, and 4. We could not do dose level 2 as we only had data on 2 patients and need an n\>2 to do paired analyses.|Wilcoxon test|||||||0.8665
72605281|NCT01519817|144738453|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.88||||||The reported p-value is representative of the changes in levels of all CD8 cells at dose levels 1, 3, and 4. We could not do dose level 2 as we only had data on 2 patients and need an n\>2 to do paired analyses.|Wilcoxon test|||||||0.88
72605282|NCT01519817|144738453|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.84||||||The reported p-value is representative of the changes in levels of CD8 cells at dose level 3.|Wilcoxon test|||||||0.84
72605283|NCT01519817|144738453|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.57||||||The reported p-value is representative of the changes in levels of CD8 cells at dose level 4.|Wilcoxon test|||||||0.57
72605284|NCT01519817|144738453|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.3052||||||The reported p-value is representative of the changes in levels of all B cells at dose levels 1, 3, and 4. We could not do dose level 2 as we only had data on 2 patients and need an n\>2 to do paired analyses.|Wilcoxon test|||||||0.3052
72605285|NCT01519817|144738453|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.|||||>|0.9999||||||The reported p-value is representative of the changes in levels of B cells at dose level 1.|Wilcoxon test|The reported p-value is representative of the changes in levels of B cells at dose level 1.||||||>0.9999
72416262|NCT01972841|144343309|SUPERIORITY||Rate ratio|0.88|STANDARD_ERROR_OF_MEAN|0.05||0.006|TWO_SIDED|95.0|0.81|0.96|||Negative binomial regression|||Rate ratio of number of incontinence episodes during the 7-day diary between the given combination group and the given monotherapy group calculated from a negative binomial regression model incl. treatment group, sex, age group (\<65, \>=65 years), geographic region and previous OAB medication (yes, no) as factors, baseline log(number of nocturia episodes used divided by number of valid diary days) included as a covariate and postbaseline number of valid diary days as offset variable.||0.96|0.81|0.006
72605286|NCT01519817|144738453|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.13||||||The reported p-value is representative of the changes in levels of B cells at dose level 3.|Wilcoxon test|||||||0.13
72605287|NCT01519817|144738453|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.65||||||The reported p-value is representative of the changes in levels of B cells at dose level 4.|Wilcoxon test|||||||0.65
72605288|NCT01519817|144738453|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.0698||||||The reported p-value is representative of the changes in levels of all NK cells at dose levels 1, 3, and 4. We could not do dose level 2 as we only had data on 2 patients and need an n\>2 to do paired analyses.|Wilcoxon test|||||||0.0698
72605289|NCT01519817|144738453|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.63||||||The reported p-value is representative of the changes in levels of NK cells at dose level 1.|Wilcoxon test|||||||0.63
72605290|NCT01519817|144738453|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.74||||||The reported p-value is representative of the changes in levels of NK cells at dose level 3.|Wilcoxon test|||||||0.74
72416263|NCT01972841|144343309|SUPERIORITY||Rate ratio|0.81|STANDARD_ERROR_OF_MEAN|0.05|<|0.001|TWO_SIDED|95.0|0.74|0.88|||Negative binomial regression|||Rate ratio of number of incontinence episodes during the 7-day diary between the given combination group and the given monotherapy group calculated from a negative binomial regression model incl. treatment group, sex, age group (\<65, \>=65 years), geographic region and previous OAB medication (yes, no) as factors, baseline log(number of nocturia episodes used divided by number of valid diary days) included as a covariate and postbaseline number of valid diary days as offset variable.||0.88|0.74|<0.001
72605291|NCT01519817|144738453|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.13||||||The reported p-value is representative of the changes in levels of NK cells at dose level 4.|Wilcoxon test|||||||0.13
72605292|NCT01519817|144738453|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.0127||||||The reported p-value is representative of the changes in levels of all NKT cells at dose levels 1, 3, and 4. We could not do dose level 2 as we only had data on 2 patients and need an n\>2 to do paired analyses.|Wilcoxon test|||||||0.0127
72605293|NCT01519817|144738453|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.63||||||The reported p-value is representative of the changes in levels of NKT cells at dose level 1.|Wilcoxon test|||||||0.63
72605294|NCT01519817|144738453|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.41||||||The reported p-value is representative of the changes in levels of NKT cells at dose level 3.|Wilcoxon test|||||||0.41
72605295|NCT01519817|144738453|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.07||||||The reported p-value is representative of the changes in levels of NKT cells at dose level 4.|Wilcoxon test|||||||0.07
72605296|NCT01519817|144738453|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.0654||||||The reported p-value is representative of the changes in levels of all cDC cells at dose levels 1, 3, and 4. We could not do dose level 2 as we only had data on 2 patients and need an n\>2 to do paired analyses.|Wilcoxon test|||||||0.0654
72605297|NCT01519817|144738453|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.38||||||The reported p-value is representative of the changes in levels of cDC cells at dose level 1.|Wilcoxon test|||||||0.38
72605298|NCT01519817|144738453|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.21||||||The reported p-value is representative of the changes in levels of cDC cells at dose level 3.|Wilcoxon test|||||||0.21
72605299|NCT01519817|144738453|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.16||||||The reported p-value is representative of the changes in levels of cDC cells at dose level 4.|Wilcoxon test|||||||0.16
72605300|NCT01519817|144738453|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.0457||||||The reported p-value is representative of the changes in levels of all pDC cells at dose levels 1, 3, and 4. We could not do dose level 2 as we only had data on 2 patients and need an n\>2 to do paired analyses.|Wilcoxon test|||||||0.0457
72605301|NCT01519817|144738453|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.63||||||The reported p-value is representative of the changes in levels of pDC cells at dose level 1.|Wilcoxon test|||||||0.63
72605302|NCT01519817|144738453|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.55||||||The reported p-value is representative of the changes in levels of pDC cells at dose level 3.|Wilcoxon test|||||||0.55
72605303|NCT01519817|144738453|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.13||||||The reported p-value is representative of the changes in levels of pDC cells at dose level 4.|Wilcoxon test|||||||0.13
72605304|NCT01519817|144738453|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.7114||||||The reported p-value is representative of the changes in levels of all MDSC cells at dose levels 1, 3, and 4. We could not do dose level 2 as we only had data on 2 patients and need an n\>2 to do paired analyses.|Wilcoxon test|||||||0.7114
72605305|NCT01519817|144738453|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.|||||>|0.9999||||||The reported p-value is representative of the changes in levels of MDSC cells at dose level 1.|Wilcoxon test|||||||>0.9999
72605306|NCT01519817|144738453|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.38||||||The reported p-value is representative of the changes in levels of MDSC cells at dose level 3.|Wilcoxon test|||||||0.38
72605307|NCT01519817|144738453|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.91||||||The reported p-value is representative of the changes in levels of MDSC cells at dose level 4.|Wilcoxon test|||||||0.91
72605308|NCT01519817|144738453|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.2666||||||The reported p-value is representative of the changes in levels of all Treg cells at dose levels 1, 3, and 4. We could not do dose level 2 as we only had data on 2 patients and need an n\>2 to do paired analyses.|Wilcoxon test|||||||0.2666
72605309|NCT01519817|144738453|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.88||||||The reported p-value is representative of the changes in levels of Treg cells at dose level 1.|Wilcoxon test|||||||0.88
72605310|NCT01519817|144738453|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.45||||||The reported p-value is representative of the changes in levels of Treg cells at dose level 1.|Wilcoxon test|||||||0.45
72605311|NCT01519817|144738453|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.36||||||The reported p-value is representative of the changes in levels of Treg cells at dose level 4.|Wilcoxon test|||||||0.36
72605312|NCT01519817|144738453|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.0076||||||The reported p-value is representative of the changes in levels of all CD4 EM cells at dose levels 1, 3, and 4. We could not do dose level 2 as we only had data on 2 patients and need an n\>2 to do paired analyses.|Wilcoxon test|||||||0.0076
72605313|NCT01519817|144738453|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.38||||||The reported p-value is representative of the changes in levels of CD4 EM cells at dose level 1.|Wilcoxon test|||||||0.38
72605314|NCT01519817|144738453|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.22||||||The reported p-value is representative of the changes in levels of CD4 EM cells at dose level 3.|Wilcoxon test|||||||0.22
72605315|NCT01519817|144738453|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.1||||||The reported p-value is representative of the changes in levels of CD4 EM cells at dose level 4.|Wilcoxon test|||||||0.10
72605316|NCT01519817|144738453|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.7144||||||The reported p-value is representative of the changes in levels of all CD4 CM cells at dose levels 1, 3, and 4. We could not do dose level 2 as we only had data on 2 patients and need an n\>2 to do paired analyses.|Wilcoxon test|||||||0.7144
72605317|NCT01519817|144738453|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.13||||||The reported p-value is representative of the changes in levels of CD4 CM cells at dose level 1.|Wilcoxon test|||||||0.13
72605318|NCT01519817|144738453|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.06||||||The reported p-value is representative of the changes in levels of CD4 CM cells at dose level 3.|Wilcoxon test|||||||0.06
72605319|NCT01519817|144738453|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.13||||||The reported p-value is representative of the changes in levels of CD4 CM cells at dose level 4.|Wilcoxon test|||||||0.13
72605320|NCT01519817|144738453|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.3741||||||The reported p-value is representative of the changes in levels of all CD4 EMRA cells at dose levels 1, 3, and 4. We could not do dose level 2 as we only had data on 2 patients and need an n\>2 to do paired analyses.|Wilcoxon test|||||||0.3741
72605321|NCT01519817|144738453|NON_INFERIORITY|The reported p-value is representative of the changes in levels of CD4 EMRA cells at dose level 1.||||||0.63|||||||Wilcoxon test|||||||0.63
72605322|NCT01519817|144738453|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.13||||||The reported p-value is representative of the changes in levels of CD4 EMRA cells at dose level 3.|Wilcoxon test|||||||0.13
72605323|NCT01519817|144738453|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.|||||>|0.9999||||||The reported p-value is representative of the changes in levels of CD4 EMRA cells at dose level 4.|Wilcoxon test|||||||>0.9999
72416264|NCT01972841|144343309|SUPERIORITY||Rate ratio|0.91|STANDARD_ERROR_OF_MEAN|0.05||0.049|TWO_SIDED|95.0|0.84|1.0|||Negative binomial regression|||Rate ratio of number of incontinence episodes during the 7-day diary between the given combination group and the given monotherapy group calculated from a negative binomial regression model incl. treatment group, sex, age group (\<65, \>=65 years), geographic region and previous OAB medication (yes, no) as factors, baseline log(number of nocturia episodes used divided by number of valid diary days) included as a covariate and postbaseline number of valid diary days as offset variable.||1.00|0.84|0.049
72605324|NCT01519817|144738453|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.3386||||||The reported p-value is representative of the changes in levels of all CD4 naive cells at dose levels 1, 3, and 4. We could not do dose level 2 as we only had data on 2 patients and need an n\>2 to do paired analyses.|Wilcoxon test|||||||0.3386
72605325|NCT01519817|144738453|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.88||||||The reported p-value is representative of the changes in levels of CD4 naive cells at dose level 1.|Wilcoxon test|||||||0.88
72605326|NCT01519817|144738453|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.0215||||||The reported p-value is representative of the changes in levels of CD4 naive cells at dose level 3.|Wilcoxon test|||||||0.0215
72605327|NCT01519817|144738453|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.65||||||The reported p-value is representative of the changes in levels of CD4 naive cells at dose level 4.|Wilcoxon test|||||||0.65
72605328|NCT01519817|144738453|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.5076||||||The reported p-value is representative of the changes in levels of all CD8 EM cells at dose levels 1, 3, and 4. We could not do dose level 2 as we only had data on 2 patients and need an n\>2 to do paired analyses.|Wilcoxon test|||||||0.5076
72605329|NCT01519817|144738453|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.63||||||The reported p-value is representative of the changes in levels of CD8 EM cells at dose level 1.|Wilcoxon test|||||||0.63
72605330|NCT01519817|144738453|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.68||||||The reported p-value is representative of the changes in levels of CD8 EM cells at dose level 3.|Wilcoxon test|||||||0.68
72605331|NCT01519817|144738453|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.73||||||The reported p-value is representative of the changes in levels of CD8 EM cells at dose level 4.|Wilcoxon test|||||||0.73
72605332|NCT01519817|144738453|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.6577||||||The reported p-value is representative of the changes in levels of all CD8 CM cells at dose levels 1, 3, and 4. We could not do dose level 2 as we only had data on 2 patients and need an n\>2 to do paired analyses.|Wilcoxon test|||||||0.6577
72605333|NCT01519817|144738453|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.88||||||The reported p-value is representative of the changes in levels of CD8 CM cells at dose level 1.|Wilcoxon test|||||||0.88
72605334|NCT01519817|144738453|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.74||||||The reported p-value is representative of the changes in levels of CD8 CM cells at dose level 3.|Wilcoxon test|||||||0.74
72605335|NCT01519817|144738453|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.2||||||The reported p-value is representative of the changes in levels of CD8 CM cells at dose level 4.|Wilcoxon test|||||||0.20
72605336|NCT01519817|144738453|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.6295||||||The reported p-value is representative of the changes in levels of all CD8 EMRA cells at dose levels 1, 3, and 4. We could not do dose level 2 as we only had data on 2 patients and need an n\>2 to do paired analyses.|Wilcoxon test|||||||0.6295
72605337|NCT01519817|144738453|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.63||||||The reported p-value is representative of the changes in levels of CD8 EMRA cells at dose level 1.|Wilcoxon test|||||||0.63
72605338|NCT01519817|144738453|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.|||||>|0.999||||||The reported p-value is representative of the changes in levels of CD8 EMRA cells at dose level 3.|Wilcoxon test|||||||>0.999
72605339|NCT01519817|144738453|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.36||||||The reported p-value is representative of the changes in levels of CD8 EMRA cells at dose level 4.|Wilcoxon test|||||||0.36
72605340|NCT01519817|144738453|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.8314||||||The reported p-value is representative of the changes in levels of all CD8 naive cells at dose levels 1, 3, and 4. We could not do dose level 2 as we only had data on 2 patients and need an n\>2 to do paired analyses.|Wilcoxon test|||||||0.8314
72605341|NCT01519817|144738453|NON_INFERIORITY|The reported p-value is representative of the changes in levels of CD8 naive cells at dose level 1.||||||0.63|||||||Wilcoxon test|||||||0.63
72605342|NCT01519817|144738453|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.64||||||The reported p-value is representative of the changes in levels of CD8 naive cells at dose level 3.|Wilcoxon test|||||||0.64
72605343|NCT01519817|144738453|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.3||||||The reported p-value is representative of the changes in levels of CD8 naive cells at dose level 4.|Wilcoxon test|||||||0.30
72605344|NCT01519817|144738454|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.375||||||The reported p-value is representative of the changes in levels of IFNg cytokines at dose level 1.|Wilcoxon test|||||||0.375
72605345|NCT01519817|144738454|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.4808||||||The reported p-value is representative of the changes in levels of all IFNg cytokines at dose levels 1, 3, and 4. We could not do dose level 2 as we only had data on 2 patients and need an n\>2 to do paired analyses.|Wilcoxon test|||||||0.4808
72605346|NCT01519817|144738454|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.7334||||||The reported p-value is representative of the changes in levels of IFNg cytokines at dose level 3.|Wilcoxon test|||||||0.7334
72605347|NCT01519817|144738454|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.7109||||||The reported p-value is representative of the changes in levels of IFNg cytokines at dose level 4.|Wilcoxon|||||||0.7109
72605348|NCT01519817|144738454|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.4347||||||The reported p-value is representative of the changes in levels of all IL10 cytokines at dose levels 1, 3, and 4. We could not do dose level 2 as we only had data on 2 patients and need an n\>2 to do paired analyses.|Wilcoxon test|||||||0.4347
72605349|NCT01519817|144738454|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.|||||>|0.9999||||||The reported p-value is representative of the changes in levels of IL10 cytokines at dose level 1.|Wilcoxon|||||||>0.9999
72605350|NCT01519817|144738454|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.748||||||The reported p-value is representative of the changes in levels of IL10 cytokines at dose level 3.|Wilcoxon test|||||||0.748
72605351|NCT01519817|144738454|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.8203|||||||Wilcoxon test|The reported p-value is representative of the changes in levels of IL10 cytokines at dose level 4.||||||0.8203
72605352|NCT01519817|144738454|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.5625||||||The reported p-value is representative of the changes in levels of all IL12p70 cytokines at dose levels 1, 3, and 4. We could not do dose level 2 as we only had data on 2 patients and need an n\>2 to do paired analyses.|Wilcoxon test|||||||0.5625
72605353|NCT01519817|144738454|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.|||||>|0.9999||||||The reported p-value is representative of the changes in levels of IL12p70 cytokines at dose level 1.|Wilcoxon test|||||||>0.9999
72605354|NCT01519817|144738454|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.|||||>|0.9999||||||The reported p-value is representative of the changes in levels of IL12p70 cytokines at dose level 3.|Wilcoxon test|||||||>0.9999
72605355|NCT01519817|144738454|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.5||||||The reported p-value is representative of the changes in levels of IL12p70 cytokines at dose level 14|Wilcoxon test|||||||0.5
72605356|NCT01519817|144738454|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.6846||||||The reported p-value is representative of the changes in levels of all IL1b cytokines at dose levels 1, 3, and 4. We could not do dose level 2 as we only had data on 2 patients and need an n\>2 to do paired analyses.|Wilcoxon test|||||||0.6846
72605357|NCT01519817|144738454|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.|||||>|0.9999||||||The reported p-value is representative of the changes in levels of IL1b cytokines at dose level 1.|Wilcoxon test|||||||>0.9999
72605358|NCT01519817|144738454|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.5||||||The reported p-value is representative of the changes in levels of IL1b cytokines at dose level 3.|Wilcoxon test|||||||0.5
72605359|NCT01519817|144738454|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.|||||>|0.9999||||||The reported p-value is representative of the changes in levels of IL1b cytokines at dose level 4.|Wilcoxon test|||||||>0.9999
72605360|NCT01519817|144738454|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.4375||||||The reported p-value is representative of the changes in levels of all IL-2 cytokines at dose levels 1, 3, and 4. We could not do dose level 2 as we only had data on 2 patients and need an n\>2 to do paired analyses.|Wilcoxon test|||||||0.4375
72605361|NCT01519817|144738454|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.|||||>|0.9999||||||The reported p-value is representative of the changes in levels of IL-2 cytokines at dose level 1.|Wilcoxon test|||||||>0.9999
72605362|NCT01519817|144738454|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.|||||>|0.9999||||||The reported p-value is representative of the changes in levels of IL-2 cytokines at dose level 3.|Wilcoxon test|||||||>0.9999
72605363|NCT01519817|144738454|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.75||||||The reported p-value is representative of the changes in levels of IL-2 cytokines at dose level 4.|Wilcoxon test|||||||0.75
72605364|NCT01519817|144738454|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.4525||||||The reported p-value is representative of the changes in levels of all IL-6 cytokines at dose levels 1, 3, and 4. We could not do dose level 2 as we only had data on 2 patients and need an n\>2 to do paired analyses.|Wilcoxon test|The reported p-value is representative of the changes in levels of IL-6 cytokines at dose level 1.||||||0.4525
72605365|NCT01519817|144738454|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.875||||||The reported p-value is representative of the changes in levels of IL-6 cytokines at dose level 1.|Wilcoxon test|||||||0.875
72605366|NCT01519817|144738454|NON_INFERIORITY|The reported p-value is representative of the changes in levels of IL-6 cytokines at dose level 3.||||||0.4316|||||||Wilcoxon test|||Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||0.4316
72605367|NCT01519817|144738454|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.|||||>|0.9999||||||The reported p-value is representative of the changes in levels of IL-6 cytokines at dose level 4.|Wilcoxon test|||||||>0.9999
72605368|NCT01519817|144738454|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.9906||||||The reported p-value is representative of the changes in levels of all IL-8 cytokines at dose levels 1, 3, and 4. We could not do dose level 2 as we only had data on 2 patients and need an n\>2 to do paired analyses.|Wilcoxon test|||||||0.9906
72605369|NCT01519817|144738454|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.625|||||||Wilcoxon test|The reported p-value is representative of the changes in levels of IL-8 cytokines at dose level 1.||||||0.625
72605370|NCT01519817|144738454|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.791||||||The reported p-value is representative of the changes in levels of IL-8 cytokines at dose level 3.|Wilcoxon test|||||||0.791
72605371|NCT01519817|144738454|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.8203||||||The reported p-value is representative of the changes in levels of IL-8 cytokines at dose level 4.|Wilcoxon test|||||||0.8203
72605372|NCT01519817|144738454|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.|||||>|0.9999||||||The reported p-value is representative of the changes in levels of all TNF cytokines at dose levels 1, 3, and 4. We could not do dose level 2 as we only had data on 2 patients and need an n\>2 to do paired analyses.|Wilcoxon test|||||||>0.9999
72605373|NCT01519817|144738454|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.875||||||The reported p-value is representative of the changes in levels of TNF cytokines at dose level 1.|Wilcoxon test|||||||0.875
72605374|NCT01519817|144738454|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.9658||||||The reported p-value is representative of the changes in levels of TNF cytokines at dose level 3.|Wilcoxon test|||||||0.9658
72605375|NCT01519817|144738454|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.6523||||||The reported p-value is representative of the changes in levels of TNF cytokines at dose level 4.|Wilcoxon test|||||||0.6523
72605376|NCT01519817|144738455|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.2901||||||The reported p-value is representative of the changes in levels of all sCD27 cytokines at dose levels 1, 3, and 4. We could not do dose level 2 as we only had data on 2 patients and need an n\>2 to do paired analyses.|Wilcoxon test|||||||0.2901
72605377|NCT01519817|144738455|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.375||||||The reported p-value is representative of the changes in levels of sCD27 cytokines at dose level 1.|Wilcoxon test|||||||0.375
72605378|NCT01519817|144738455|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.2036||||||The reported p-value is representative of the changes in levels of sCD27 cytokines at dose level 3.|Wilcoxon test|||||||0.2036
72605379|NCT01519817|144738455|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.0742||||||The reported p-value is representative of the changes in levels of sCD27 cytokines at dose level 4.|Wilcoxon test|||||||0.0742
72605380|NCT01519817|144738456|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.1004||||||The reported p-value is representative of the changes in levels of all ratio sCD27:sCD40AL cytokines at dose levels 1, 3, and 4. We could not do dose level 2 as we only had data on 2 patients and need an n\>2 to do paired analyses.|Wilcoxon test|||||||0.1004
72605381|NCT01519817|144738456|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.625||||||The reported p-value is representative of the changes in levels of ratio sCD27:sCD40L cytokines at dose level 1.|Wilcoxon test|||||||0.625
72605382|NCT01519817|144738456|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.6772||||||The reported p-value is representative of the changes in levels of ratio sCD27:sCD40L cytokines at dose level 3.|Wilcoxon test|||||||0.6772
72605383|NCT01519817|144738456|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.3008||||||The reported p-value is representative of the changes in levels of ratio sCD27:sCD40L cytokines at dose level 4.|Wilcoxon test|||||||0.3008
72605384|NCT01519817|144738457|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.0621||||||The reported p-value is representative of the changes in levels of all sCD40L cytokines at dose levels 1, 3, and 4. We could not do dose level 2 as we only had data on 2 patients and need an n\>2 to do paired analyses.|Wilcoxon test|||||||0.0621
72605385|NCT01519817|144738457|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.875||||||The reported p-value is representative of the changes in levels of sCD40L cytokines at dose level 1.|Wilcoxon test|||||||0.875
72605386|NCT01519817|144738457|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.2402||||||The reported p-value is representative of the changes in levels of sCD40L cytokines at dose level 3.|Wilcoxon test|||||||0.2402
72605387|NCT01519817|144738457|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.3008||||||The reported p-value is representative of the changes in levels of sCD40L cytokines at dose level 4.|Wilcoxon test|||||||0.3008
72605388|NCT04547140|144738527|SUPERIORITY||Difference in percentages|3.3|||||TWO_SIDED|||||||||Percentage of Participants Dying||||
72605389|NCT04547140|144738527|SUPERIORITY||Difference in percentages|6.4|||||TWO_SIDED|||||||||Percentage of Participants Requiring ICU Admission||||
72605390|NCT04547140|144738528|SUPERIORITY||Difference in percentages|6.9|||||TWO_SIDED|||||||||Percentage of Participants Who are Dependent on High Flow Oxygen Devices||||
72605391|NCT04547140|144738528|SUPERIORITY||Difference in percentages|3.4|||||TWO_SIDED|||||||||Percentage of Participants Who are Dependent on Invasive Mechanical Ventilation||||
72605392|NCT04547140|144738529|SUPERIORITY||Least Squares (LS) Mean Difference|1.22||||0.1453|TWO_SIDED|95.0|-0.43|2.87||P-value was calculated using restricted maximum likelihood with the Kenward-Roger method for calculating the denominator degrees of freedom.|Kenward-Roger|||Day 15||2.87|-0.43|0.1453
72605393|NCT04547140|144738529|SUPERIORITY||LS Mean Difference|0.21||||0.8015|TWO_SIDED|95.0|-1.44|1.86||P-value was calculated using restricted maximum likelihood with the Kenward-Roger method for calculating the denominator degrees of freedom.|Kenward-Roger|||Day 29||1.86|-1.44|0.8015
72605394|NCT04547140|144738531|SUPERIORITY||LS Mean Difference of Duration|1.48||||0.5135|TWO_SIDED|95.0|-3.04|6.0||P-value was calculated using an analysis of variance (ANOVA) model, including the length of hospital stay (days) as a dependent variable and treatment group as a fixed effect.|ANOVA|||||6.00|-3.04|0.5135
72605395|NCT04547140|144738532|SUPERIORITY||LS Mean Difference of Duration|3.41||||0.1221|TWO_SIDED|95.0|-0.94|7.76||P-value was calculated using an ANOVA model, including the number of days in the ICU as a dependent variable and treatment group as a fixed effect.|ANOVA|||||7.76|-0.94|0.1221
72605396|NCT04547140|144738533|SUPERIORITY||LS Mean Difference of Duration|2.78||||0.3329|TWO_SIDED|95.0|-2.92|8.48||P-value was calculated using an ANOVA model, including the number of days on oxygen as a dependent variable and treatment group as a fixed effect.|ANOVA|||||8.48|-2.92|0.3329
72605397|NCT04547140|144738534|SUPERIORITY||LS Mean Difference of Duration|3.48||||0.1092|TWO_SIDED|95.0|-0.81|7.77||P-value was calculated using an ANOVA model, including the number of days on mechanical ventilation as a dependent variable and treatment group as a fixed effect.|ANOVA|||||7.77|-0.81|0.1092
72605398|NCT04547140|144738535|SUPERIORITY||LS Mean Difference|-0.63||||0.1189|TWO_SIDED|95.0|-1.43|0.17||P-value was calculated using restricted maximum likelihood with the Kenward-Roger method for calculating the denominator degrees of freedom.|Kenward-Roger|||Day 15||0.17|-1.43|0.1189
72605399|NCT04547140|144738535|SUPERIORITY||LS Mean Difference|-0.85||||0.0341|TWO_SIDED|95.0|-1.64|-0.07||P-value was calculated using restricted maximum likelihood with the Kenward-Roger method for calculating the denominator degrees of freedom.|Kenward-Roger|||Day 29||-0.07|-1.64|0.0341
72605400|NCT04547140|144738539|SUPERIORITY||Difference in percentages|1.9||||0.8809|TWO_SIDED|95.0|-24.1|28.3||P-value was calculated using Chi-square test with 5% level of significance to test the null hypothesis of no difference in the percentages of participants experiencing sustained normalization of fever.|Chi-squared|||||28.3|-24.1|0.8809
72605401|NCT00737100|144738558|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.94||||0.001||95.0|1.19|4.7||Comment for p-value: Hierarchical testing was applied. Comparison of 2.5 dose to be performed only if superiority of tiotropium 5.0 dose compared to placebo was shown for both primary endpoints.|Mixed Models Analysis|Adjusted for baseline, center, visit and age group||Comparison of Tiotropium 2.5 microgram dose versus placebo||4.70|1.19|0.001
72605402|NCT00737100|144738558|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.39||||0.0001||95.0|1.67|5.12||Comment for p-value: Hierarchical testing was applied. Comparison of 2.5 dose to be performed only if superiority of tiotropium 5.0 dose compared to placebo was shown for both primary endpoints.|Mixed Models Analysis|Adjusted for baseline, center, visit and age group||Comparison of Tiotropium 5.0 microgram dose versus placebo||5.12|1.67|0.0001
72605403|NCT00737100|144738559|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.24||||0.0184||95.0|0.38|4.11||Comment for p-value: Hierarchical testing was applied. Comparison of 2.5 dose to be performed only if superiority of tiotropium 5.0 dose compared to placebo was shown for both primary endpoints.|Mixed Models Analysis|Adjusted for baseline, center, visit and age group||Comparison of Tiotropium 2.5 microgram dose versus placebo||4.11|0.38|0.0184
72605404|NCT00737100|144738559|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.22||||0.0179||95.0|0.38|4.06||Comment for p-value: Hierarchical testing was applied. Comparison of 2.5 dose to be performed only if superiority of tiotropium 5.0 dose compared to placebo was shown for both primary endpoints.|Mixed Models Analysis|Adjusted for baseline, center, visit and age group||Comparison of Tiotropium 5.0 microgram dose versus placebo||4.06|0.38|0.0179
72605405|NCT00737100|144738560|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.83||||0.0756||95.0|-0.19|3.86|||Mixed Models Analysis|Adjusted for baseline, center, visit and age group||Comparison of Tiotropium 2.5 microgram dose versus placebo||3.86|-0.19|0.0756
72605406|NCT00737100|144738560|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.12||||0.0023||95.0|1.12|5.12|||Mixed Models Analysis|Adjusted for baseline, center, visit and age group||Comparison of Tiotropium 5.0 microgram dose versus placebo||5.12|1.12|0.0023
72605407|NCT00737100|144738561|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.85||||0.3857||95.0|-1.08|2.79|||Mixed Models Analysis|Adjusted for baseline, center, visit and age group||Comparison of Tiotropium 2.5 microgram dose versus placebo||2.79|-1.08|0.3857
72605408|NCT00737100|144738561|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.19||||0.2199||95.0|-0.72|3.11|||Mixed Models Analysis|Adjusted for baseline, center, visit and age group||Comparison of Tiotropium 5.0 microgram dose versus placebo||3.11|-0.72|0.2199
72605409|NCT00737100|144738562|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.19||||0.0363||95.0|0.27|8.11|||Mixed Models Analysis|Adjusted for baseline, center, visit and age group||Comparison of Tiotropium 2.5 microgram dose versus placebo||8.11|0.27|0.0363
72605410|NCT00737100|144738562|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.34||||0.0073||95.0|1.45|9.23|||Mixed Models Analysis|Adjusted for baseline, center, visit and age group||Comparison of Tiotropium 5.0 microgram dose versus placebo||9.23|1.45|0.0073
72605411|NCT00737100|144738563|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01||||0.7414||95.0|-0.06|0.08|||Mixed Models Analysis|Adjusted for baseline, center, visit and age group||Comparison of Tiotropium 2.5 microgram dose versus placebo||0.08|-0.06|0.7414
72416265|NCT01972841|144343309|SUPERIORITY||Rate ratio|0.86|STANDARD_ERROR_OF_MEAN|0.05||0.001|TWO_SIDED|95.0|0.79|0.94|||Negative binomial regression|||Rate ratio of number of incontinence episodes during the 7-day diary between the given combination group and the given monotherapy group calculated from a negative binomial regression model incl. treatment group, sex, age group (\<65, \>=65 years), geographic region and previous OAB medication (yes, no) as factors, baseline log(number of nocturia episodes used divided by number of valid diary days) included as a covariate and postbaseline number of valid diary days as offset variable.||0.94|0.79|0.001
72605412|NCT00737100|144738563|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.05||||0.1418||95.0|-0.02|0.12|||Mixed Models Analysis|Adjusted for baseline, center, visit and age group||Comparison of Tiotropium 5.0 microgram dose versus placebo||0.12|-0.02|0.1418
72605413|NCT00737100|144738564|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.79||||0.8515||95.0|0.37|1.72|||Regression, Logistic|Covariates of treatment and age group||Comparison of Tiotropium 2.5 microgram dose versus placebo||1.72|0.37|0.8515
72605414|NCT00737100|144738564|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.72||||0.5565||95.0|0.33|1.59|||Regression, Logistic|Adjusted for baseline, center, visit and age group||Comparison of Tiotropium 5.0 microgram dose versus placebo||1.59|0.33|0.5565
72416266|NCT01972841|144343310|SUPERIORITY||Least squares mean difference|-0.61|STANDARD_ERROR_OF_MEAN|0.34||0.073|TWO_SIDED|95.0|-1.28|0.06|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (solifenacin 5 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||0.06|-1.28|0.073
72605415|NCT04033146|144738589|OTHER||||||<|0.001||||||Threshold was 0.05|ANOVA|||"H1. Bilateral ankle exoskeletons that provide 'motor-like' assistance will result in lower net metabolic power than those providing 'spring-like' assistance for young adults.~H2. Bilateral ankle exoskeletons that provide 'motor-like' assistance will result in lower net metabolic power than those providing 'spring-like' assistance for older adults."||||<0.001
72605416|NCT01064414|144738618|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.117||0.012|TWO_SIDED|95.0|-0.529|-0.066|||ANCOVA|||||-0.066|-0.529|0.012
72605417|NCT01064414|144738618|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.117|<|0.001|TWO_SIDED|95.0|-0.635|-0.174|||ANCOVA|||||-0.174|-0.635|<0.001
72605418|NCT01064414|144738619|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.66||||0.227|TWO_SIDED|95.0|0.73|3.77|||Regression, Logistic|||||3.77|0.73|0.227
72416267|NCT01972841|144343310|SUPERIORITY||Least squares mean difference|-1.16|STANDARD_ERROR_OF_MEAN|0.34||0.001|TWO_SIDED|95.0|-1.83|-0.48|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (solifenacin 5 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||-0.48|-1.83|0.001
72416268|NCT01972841|144343310|SUPERIORITY||Least squares mean difference|-0.51|STANDARD_ERROR_OF_MEAN|0.34||0.14|TWO_SIDED|95.0|-1.18|0.17|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (mirabegron 25 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||0.17|-1.18|0.140
72605419|NCT01064414|144738619|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.69||||0.017|TWO_SIDED|95.0|1.19|6.04|||Regression, Logistic|||||6.04|1.19|0.017
72605420|NCT01064414|144738620|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-15.4|STANDARD_ERROR_OF_MEAN|6.638||0.021|TWO_SIDED|95.0|-28.45|-2.307|||ANCOVA|||||-2.307|-28.45|0.021
72605421|NCT01064414|144738620|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-12.2|STANDARD_ERROR_OF_MEAN|6.683||0.069|TWO_SIDED|95.0|-25.36|0.962|||ANCOVA|||||0.962|-25.36|0.069
72605422|NCT00249873|144738621|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.89||||0.0133||95.0|0.81|0.98||Cumulative incidence functions in each treatment group were calculated using non-parametric Kaplan-Meier estimates. Median time-to-event was not reached in any group. The primary comparison was performed at the 5% level using a 2-sided Log rank test.|Log Rank||The hazard ratio was estimated by a Cox's proportional hazard model with treatment arm factor. It represents the relative hazard of any component of the primary event for the clopidogrel group compared with the Placebo group.|||0.98|0.81|0.0133
72605423|NCT00249873|144738622|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.72|||<|0.001||95.0|0.62|0.83||Cumulative incidence functions in each treatment group were calculated using non-parametric Kaplan-Meier estimates. Median time-to-event was not reached in any group. The primary comparison was performed at the 5% level using a 2-sided Log rank test.|Log Rank||The hazard ratio was estimated by a Cox's proportional hazard model with treatment arm factor. It represents the relative hazard of stroke for the clopidogrel group compared with the Placebo group.|||0.83|0.62|<0.001
72605424|NCT00249873|144738623|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.98||||0.696||95.0|0.89|1.08||Cumulative incidence functions in each treatment group were calculated using non-parametric Kaplan-Meier estimates. Median time-to-event was not reached in any group. The primary comparison was performed at the 5% level using a 2-sided Log rank test.|Log Rank||The hazard ratio was estimated by a Cox's proportional hazard model with treatment arm factor. It represents the relative hazard of death from any cause for the clopidogrel group compared with the Placebo group.|||1.08|0.89|0.696
72605425|NCT00249873|144738624|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Chi-squared|||||||<0.001
72605426|NCT00643201|144738628|NON_INFERIORITY_OR_EQUIVALENCE|Statistical Testing: non-inferiority tested at 1-sided α=0.025 with margin of 1.8. Demonstration of non-inferiority using both relative risk (RR) (margin = 1.8) and risk difference (RD) (margin = 0.035) were required to achieve the primary objective.|Risk Ratio (RR)|0.839|||<|0.0001|TWO_SIDED|95.0|0.5965|1.1802||This is the first test in a sequential testing sequence. p-value calculated based on the Yanagawa-Tango-Hiejima test stratified by index event strata for non-inferiority. Tested at 1-sided α=0.025|Yanagawa-Tango-Hiejima|For a successful trial; rejection of the null hypotheses for both RR and RD was required.||Hypothesis that apixaban was non-inferior to enoxaparin/warfarin therapy in preventing the recurrence of VTE (nonfatal DVT or nonfatal PE)/VTE-related death.||1.1802|0.5965|<0.0001
72605427|NCT00643201|144738628|NON_INFERIORITY_OR_EQUIVALENCE|Statistical Testing; non-inferiority tested at 1-sided α=0.025. If non-inferiority demonstrated for both RR and RD, the primary objective was achieved.|Risk Difference (RD)|-0.0044|||<|0.0001|TWO_SIDED|95.0|-0.0128|0.004||Yanagawa-Tango-Hiejima test statistic for risk difference (RD).|Yanagawa-Tango-Hiejima|||Hypothesis that apixaban was non-inferior to enoxaparin/warfarin therapy in preventing the recurrence of VTE (nonfatal DVT or nonfatalPE)/VTE-related death as measured by risk difference.||0.0040|-0.0128|<0.0001
72605428|NCT00643201|144738628|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.839||||0.3128|TWO_SIDED|95.0|0.5965|1.1802||Tested at 2-sided α=0.05 significance. Further inferential statistical testing halted due to failure to reject the null hypothesis of equivalence for VTE/VTE-related death.|Cochran-Mantel-Haenszel|Relative risk, CI, and p-value were calculated based on CMH test stratified by index event strata.||Hypothesis of apixaban therapy being superior to enoxaparin/warfarin therapy for the adjudicated endpoint. Inferential testing required demonstration of non-inferiority using both RR and RD plus demonstration of superiority for major bleeding.||1.1802|0.5965|0.3128
72605429|NCT00643201|144738629|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.8151||||0.1554|TWO_SIDED|95.0|0.6146|1.0812||The test was stratified by index event strata using alpha=0.05 level of significance. Analysis was performed on the secondary efficacy dataset; there was no imputation of missing data.|Cochran-Mantel-Haenszel|Nominal p-value is reported.||Exploratory hypothesis of apixaban therapy being superior to enoxaparin/warfarin therapy for the adjudicated endpoint.||1.0812|0.6146|0.1554
72605430|NCT00643201|144738630|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.7994||||0.1848|TWO_SIDED|95.0|0.5737|1.1137||The test was stratified by index event strata using alpha=0.05 level of significance. . Nominal p-value is reported.|Cochran-Mantel-Haenszel|Analysis was performed on the secondary efficacy dataset; there was no imputation of missing data.||Exploratory hypothesis of apixaban therapy being superior to enoxaparin/warfarin therapy for the adjudicated endpoint.||1.1137|0.5737|0.1848
72605431|NCT00643201|144738631|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.6236||||0.0011|TWO_SIDED|95.0|0.4682|0.8306||The test was stratified by index event strata using alpha=0.05 level of significance. Nominal p-value is reported.|Cochran-Mantel-Haenszel|||Exploratory hypothesis of apixaban therapy being superior to enoxaparin/warfarin therapy for the adjudicated endpoint.||0.8306|0.4682|0.0011
72605432|NCT00643201|144738632|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.5532|||<|0.0001|TWO_SIDED|95.0|0.4658|0.6569||The test was stratified by index event strata using alpha=0.05 level of significance. Nominal p-value is reported.|Cochran-Mantel-Haenszel|||Exploratory hypothesis of apixaban therapy being superior to enoxaparin/warfarin therapy for the adjudicated endpoint.||0.6569|0.4658|<0.0001
72605433|NCT00643201|144738633|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.6347|||||TWO_SIDED|95.0|0.3735|1.0787|||Cochran-Mantel-Haenszel||Relative Risk and CI was calculated based on CMH test stratified by index event strata.|Exploratory hypothesis of apixaban therapy being superior to enoxaparin/warfarin therapy for the adjudicated endpoint.||1.0787|0.3735|
72605434|NCT00643201|144738634|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.0935|||||TWO_SIDED|95.0|0.6363|1.8793|||Cochran-Mantel-Haenszel||Relative Risk and CI was calculated based on CMH test stratified by index event strata.|Exploratory hypothesis of apixaban therapy being superior to enoxaparin/warfarin therapy for the adjudicated endpoint.||1.8793|0.6363|
72605435|NCT00643201|144738635|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.7521|||||TWO_SIDED|95.0|0.356|1.5889|||Cochran-Mantel-Haenszel||Relative Risk and CI was calculated based on CMH test stratified by index event strata.|Exploratory hypothesis of apixaban therapy being superior to enoxaparin/warfarin therapy for the adjudicated endpoint.||1.5889|0.3560|
72605436|NCT00643201|144738636|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.6539|||||TWO_SIDED|95.0|0.3419|1.2508|||Cochran-Mantel-Haenszel||Relative Risk and CI was calculated based on CMH test stratified by index event strata.|Exploratory hypothesis of apixaban therapy being superior to enoxaparin/warfarin therapy for the adjudicated endpoint.||1.2508|0.3419|
72605437|NCT00643201|144738637|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.7934|||||TWO_SIDED|95.0|0.5287|1.1906|||Cochran-Mantel-Haenszel||Relative Risk and CI was calculated based on CMH test stratified by index event strata.|Exploratory hypothesis of apixaban therapy being superior to enoxaparin/warfarin therapy for the adjudicated endpoint.||1.1906|0.5287|
72605438|NCT00643201|144738638|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.307|||<|0.0001|TWO_SIDED|95.0|0.1728|0.5452||p-value calculated on the CMH test stratified by index event strata.|Cochran-Mantel-Haenszel||Relative risk and CI were calculated based on CMH test stratified by index event strata.|Hypothesis: apixaban therapy being superior to enoxaparin/warfarin therapy for the adjudicated endpoint. As per the hierarchical statistical testing cascade, inferential testing for adjudicated major bleeding occurred because non-inferiority for VTE/VTE-related death (Primary efficacy endpoint) was demonstrated earlier. Rejection of the null hypothesis for equivalence for major bleeding allowed inferential testing for superiority of VTE/VTE-related death.||0.5452|0.1728|<0.0001
72605439|NCT00643201|144738639|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.441|||<|0.0001|TWO_SIDED|95.0|0.3566|0.5453||Tested at 2-sided alpha=0.05 significance.|Cochran-Mantel-Haenszel|Nominal p-value is reported.|Relative Risk and CI was calculated based on CMH test stratified by index event strata.|Exploratory hypothesis of apixaban therapy being superior to enoxaparin/warfarin therapy for the adjudicated endpoint. Inferential testing was not conducted because the null hypothesis pertaining to superiority for VTE/VTE-related death was not rejected.||0.5453|0.3566|<0.0001
72605440|NCT00643201|144738640|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.4793|||<|0.0001|TWO_SIDED|95.0|0.3815|0.6022||Tested at 2-sided alpha=0.05 significance.|Cochran-Mantel-Haenszel|Nominal p-value is reported.|Relative Risk and CI was calculated based on CMH test stratified by index event strata.|Exploratory hypothesis of apixaban therapy being superior to enoxaparin/warfarin therapy for the adjudicated endpoint.||0.6022|0.3815|<0.0001
72605441|NCT00643201|144738641|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.6182|||<|0.0001|TWO_SIDED|95.0|0.5432|0.7034||Tested at 2-sided alpha=0.05 significance.|Cochran-Mantel-Haenszel|Nominal p-value is reported.|Relative Risk and CI was calculated based on CMH test stratified by index event strata.|Exploratory hypothesis of apixaban therapy being superior to enoxaparin/warfarin therapy for the adjudicated endpoint.||0.7034|0.5432|<0.0001
72605442|NCT00643201|144738642|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.5937|||<|0.0001|TWO_SIDED|95.0|0.5318|0.6629||Tested at 2-sided alpha=0.05 significance.|Cochran-Mantel-Haenszel|Nominal p-value is reported.|Relative Risk and CI was calculated based on CMH test stratified by index event strata.|Exploratory hypothesis of apixaban therapy being superior to enoxaparin/warfarin therapy for the adjudicated endpoint.||0.6629|0.5318|<0.0001
72605443|NCT02976519|144738650|OTHER||Slope|1.2705|STANDARD_ERROR_OF_MEAN|0.0801|||TWO_SIDED|95.0|1.1067|1.4343|||||Based on the estimate for slope parameter (β), a 2-sided 95% confidence interval (CI) for the slope was computed. Standard error of the mean is actually standard error of slope.|Cmax. The basic model used for the investigation of dose proportionality was a power model (regression model applied to log-transformed data) that described the functional relationship between the dose and PK endpoints.||1.4343|1.1067|
72605444|NCT02976519|144738650|OTHER||Slope|1.1361|STANDARD_ERROR_OF_MEAN|0.0859|||TWO_SIDED|95.0|0.9598|1.3123|||||Based on the estimate for slope parameter (β), a 2-sided 95% CI for the slope was computed. Standard error of the mean is actually standard error of slope.|Cmax,13. The basic model used for the investigation of dose proportionality was a power model (regression model applied to log-transformed data) that described the functional relationship between the dose and PK endpoints.||1.3123|0.9598|
72605445|NCT02976519|144738651|OTHER||Slope|1.2743|STANDARD_ERROR_OF_MEAN|0.0739|||TWO_SIDED|95.0|1.1231|1.4255|||||Based on the estimate for slope parameter (β), a 2-sided 95% CI for the slope was computed. Standard error of the mean is actually standard error of slope.|AUC0-12. The basic model used for the investigation of dose proportionality was a power model (regression model applied to log-transformed data) that described the functional relationship between the dose and PK endpoints.||1.4255|1.1231|
72416269|NCT01972841|144343310|SUPERIORITY||Least squares mean difference|-1.21|STANDARD_ERROR_OF_MEAN|0.34|<|0.001|TWO_SIDED|95.0|-1.88|-0.54|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (mirabegron 50 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||-0.54|-1.88|<0.001
72416270|NCT01972841|144343311|SUPERIORITY||Least squares mean difference|-0.09|STANDARD_ERROR_OF_MEAN|0.05||0.065|TWO_SIDED|95.0|-0.19|0.01|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (solifenacin 5 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||0.01|-0.19|0.065
72605446|NCT02976519|144738651|OTHER||Slope|1.0924|STANDARD_ERROR_OF_MEAN|0.0793|||TWO_SIDED|95.0|0.9296|1.2551|||||Based on the estimate for slope parameter (β), a 2-sided 95% CI for the slope was computed. Standard error of the mean is actually standard error of slope.|AUC0-12,13. The basic model used for the investigation of dose proportionality was a power model (regression model applied to log-transformed data) that described the functional relationship between the dose and PK endpoints.||1.2551|0.9296|
72605447|NCT02346708|144738653|SUPERIORITY||Mean Difference (Final Values)|-2.07||||0.1|TWO_SIDED|95.0|-4.56|0.42||We determined whether there was a significant group difference between the real and sham treated PD-MCI patients on the DRS-2 change following rTMS using mixed model regression (MMR) to fit longitudinal models.|Mixed Models Analysis|degrees of freedom: 46||We estimated a sample size of 20 per group would provide at least 80% power at a significance level of 0.05 to detect a between-group difference of 10 on the Matthis Dementia Rating Scale-2, an effect size similar to prior studies of rivastigmine.||0.42|-4.56|0.1
72605448|NCT00928434|144738654|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was defined as a lower bound (LCL) of the 95% confidence interval for the difference between the intermittent and pooled continuous treatments, CADT, (intermittent - continuous) of greater than -12.5%.|Percentage difference|1.57|||||TWO_SIDED|95.0|-0.19|3.33||||||||3.33|-0.19|
72605449|NCT00313846|144738714|SUPERIORITY_OR_OTHER|||||||0.0026|||||||Kaplan-Meier estimate mean|||||||.0026
72605450|NCT01765296|144738723|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|"The SD for the primary efficacy outcome measure (WOMAC-Pain Subscale in the index joint) has been assumed to be 11 units. A 10% between-group difference was chosen as the non-inferiority margin for this study. The following parameters were used to calculate the sample size needed for this non-inferiority study.~* Level of significance, α = 0.025(one-sided)~* Statistical power, 1-β = 0.95~* Difference between test group and comparison group, Δ=0, δ (\>0) = non-inferiority margin"||||||0.011|||||||ANCOVA|||The primary efficacy outcome measure is the change in the WOMAC-Pain Subscale in the index joint at Week 6 vs. pre-dose Baseline and was analyzed using a mixed effect ANCOVA. Statistical tests to determine superiority between two treatment arms, CG100649 2 mg and placebo, are two-sided, and Non-inferiority between two treatment arms, CG100649 2 mg and celecoxib 200 mg is based on a one-sided 97.5% confidence interval of the difference.||||0.011
72605451|NCT01765296|144738723|NON_INFERIORITY|"The SD for the primary efficacy outcome measure (WOMAC-Pain Subscale in the index joint) has been assumed to be 11 units. A 10% between-group difference was chosen as the non-inferiority margin for this study. The following parameters were used to calculate the sample size needed for this non-inferiority study.~* Level of significance, α = 0.025(one-sided)~* Statistical power, 1-β = 0.95~* Difference between test group and comparison group, Δ=0, δ (\>0) = non-inferiority margin"||||||0.425|||||||ANCOVA|||||||0.425
72605452|NCT03933449|144738725|SUPERIORITY||Hazard Ratio (HR)|0.55||||0.0015|TWO_SIDED|95.0|0.36|0.82||One-sided p-value based on log-rank test|Log Rank||Based on Cox regression model with treatment as a covariate|||0.82|0.36|0.0015
72605453|NCT03933449|144738726|SUPERIORITY||Hazard Ratio (HR)|0.34||||0.0008|TWO_SIDED|95.0|0.17|0.69||One-sided p-value based on log-rank test|Log Rank||Based on Cox regression model with treatment as a covariate|||0.69|0.17|0.0008
72605454|NCT03933449|144738727|SUPERIORITY||Hazard Ratio (HR)|0.55||||0.0021|TWO_SIDED|95.0|0.37|0.83||One-sided p-value based on log-rank test|Log Rank||Based on Cox regression model with treatment as a covariate|||0.83|0.37|0.0021
72605455|NCT03933449|144738728|SUPERIORITY||Difference in Percentages|12.9||||0.0084|TWO_SIDED|95.0|2.7|24.5||One-sided p-value for testing. H0: difference in %=0 versus H1: difference in %\>0.|Miettinen & Nurminen method|||||24.5|2.7|0.0084
72605456|NCT03933449|144738729|SUPERIORITY||Difference in Percentages|17.1||||0.0403|TWO_SIDED|95.0|-2.3|38.0||One-sided p-value for testing. H0: difference in %=0 versus H1: difference in %\>0.|Miettinen & Nurminen method|||||38.0|-2.3|0.0403
72605457|NCT03933449|144738730|SUPERIORITY||Difference in Percentages|13.3||||0.0083|TWO_SIDED|95.0|2.8|25.2||One-sided p-value for testing. H0: difference in %=0 versus H1: difference in %\>0.|Miettinen & Nurminen method|||||25.2|2.8|0.0083
72605458|NCT03933449|144738731|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.177|TWO_SIDED|95.0|0.58|1.23||One-sided p-value based on log-rank test|Log Rank||Based on Cox regression model with treatment as a covariate|||1.23|0.58|0.177
72605459|NCT03933449|144738732|SUPERIORITY||Hazard Ratio (HR)|0.81||||0.238|TWO_SIDED|95.0|0.44|1.46||One-sided p-value based on log-rank test|Log Rank||Based on Cox regression model with treatment as a covariate|||1.46|0.44|0.238
72605460|NCT03933449|144738733|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.171|TWO_SIDED|95.0|0.57|1.23||One-sided p-value based on log-rank test|Log Rank||Based on Cox regression model with treatment as a covariate|||1.23|0.57|0.171
72605461|NCT02038179|144738766|SUPERIORITY|||||||0.83||||||Intent-to-Treat Analysis using multiple imputation. Imputed Means and Imputed Standard Errors of the Mean.|paired t-test|||||||0.83
72605462|NCT02038179|144738767|SUPERIORITY||||||<|0.001|||||||paired t-test|||||||<0.001
72605463|NCT02038179|144738768|SUPERIORITY|||||||0.84|||||||paired t-test|||||||0.84
72605464|NCT02221648|144738769|SUPERIORITY_OR_OTHER|||||||0.447|||||||Fisher Exact|||||||0.4470
72605465|NCT02221648|144738770|SUPERIORITY_OR_OTHER|||||||0.0293|||||||Fisher Exact|||||||0.0293
72605466|NCT02221648|144738771|SUPERIORITY_OR_OTHER|||||||0.0448|||||||Fisher Exact|||||||0.0448
72605467|NCT02937623|144738774|OTHER||Least square mean difference|-0.44|||<|0.0001||95.0|-0.591|-0.297|||ANCOVA|ANCOVA model: change from baseline in Schiff sensitivity score as response and treatment as factors and baseline Schiff sensitivity score as covariate|Difference is first named dentifrice minus second named dentifrice such that a negative difference favours first named dentifrice.|||-0.297|-0.591|<.0001
72605468|NCT02533934|144738780|EQUIVALENCE|Equivalence margin is defined by the a priori threshold for statistical significance.|||||<|0.01|||||||Kruskal-Wallis|||APRI change from baseline to last follow-up||||<.01
72416271|NCT01972841|144343311|SUPERIORITY||Least squares mean difference|-0.17|STANDARD_ERROR_OF_MEAN|0.05||0.001|TWO_SIDED|95.0|-0.26|-0.07|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (solifenacin 5 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||-0.07|-0.26|0.001
72416272|NCT01972841|144343311|SUPERIORITY||Least squares mean difference|-0.08|STANDARD_ERROR_OF_MEAN|0.05||0.1|TWO_SIDED|95.0|-0.18|0.02|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (mirabegron 25 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||0.02|-0.18|0.100
72416273|NCT01972841|144343311|SUPERIORITY||Least squares mean difference|-0.17|STANDARD_ERROR_OF_MEAN|0.05||0.001|TWO_SIDED|95.0|-0.26|-0.07|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (mirabegron 50 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||-0.07|-0.26|0.001
72605469|NCT02533934|144738780|EQUIVALENCE|Equivalence margin is defined by the a priori threshold for statistical significance.|||||<|0.01|||||||Kruskal-Wallis|||APRI change from baseline to last follow-up||||<.01
72605470|NCT02533934|144738780|EQUIVALENCE|Equivalence margin is defined by the a priori threshold for statistical significance|||||<|0.01|||||||Kruskal-Wallis|||FIB4 change from baseline to last follow-up||||<.01
72605471|NCT02533934|144738780|EQUIVALENCE|Equivalence margin is defined by the a priori threshold for statistical significance|||||<|0.01|||||||Kruskal-Wallis|||FIB4 change from baseline to last follow-up||||<.01
72605472|NCT02533934|144738782|EQUIVALENCE|Equivalence margin is defined by the a priori threshold for statistical significance.|||||<|0.001|||||||Wilcoxon (Signed Rank Test)|||||||<0.001
72605473|NCT01922258|144738783|SUPERIORITY||Treatment Difference|-2.34|||=|0.1454|TWO_SIDED|95.0|-5.49|0.82|||Mixed-effect model repeated measure|||||0.82|-5.49|=0.1454
72605474|NCT04552132|144738785|SUPERIORITY|||||||0.63|||||||Fisher Exact|||||||0.63
72416274|NCT01972841|144343312|SUPERIORITY||Rate ratio|1.01|STANDARD_ERROR_OF_MEAN|0.12||0.938|TWO_SIDED|95.0|0.8|1.27|||Negative binomial regression|||Rate ratio of number of incontinence episodes during the 7-day diary between the given combination group and the given monotherapy group calculated from a negative binomial regression model incl. treatment group, sex, age group (\<65, \>=65 years), geographic region and previous OAB medication (yes, no) as factors, baseline log(number of pads used divided by number of valid diary days) included as a covariate and postbaseline number of valid diary days as offset variable.||1.27|0.80|0.938
72416275|NCT01972841|144343312|SUPERIORITY||Rate ratio|1.0|STANDARD_ERROR_OF_MEAN|0.12||0.967|TWO_SIDED|95.0|0.79|1.25|||Negative binomial regression|||Rate ratio of number of incontinence episodes during the 7-day diary between the given combination group and the given monotherapy group calculated from a negative binomial regression model incl. treatment group, sex, age group (\<65, \>=65 years), geographic region and previous OAB medication (yes, no) as factors, baseline log(number of pads used divided by number of valid diary days) included as a covariate and postbaseline number of valid diary days as offset variable.||1.25|0.79|0.967
72605475|NCT04552132|144738786|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.00
72605476|NCT04552132|144738787|SUPERIORITY|||||||0.63|||||||Fisher Exact|||||||0.63
72605477|NCT04552132|144738788|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.00
72605478|NCT04552132|144738789|SUPERIORITY|||||||0.57|||||||Fisher Exact|||||||0.57
72605479|NCT04552132|144738790|SUPERIORITY|||||||0.6|||||||Fisher Exact|||||||0.60
72605480|NCT04552132|144738791|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.00
72605481|NCT04552132|144738792|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.00
72605482|NCT04552132|144738793|SUPERIORITY|||||||0.18|||||||Chi-squared|||||||0.18
72605483|NCT04552132|144738794|SUPERIORITY|||||||0.4993|||||||Chi-squared|||||||.4993
72605484|NCT04552132|144738795|SUPERIORITY|||||||0.52|||||||t-test, 2 sided|||||||0.52
72605485|NCT04552132|144738796|SUPERIORITY|||||||0.7|||||||t-test, 2 sided|||||||.70
72605486|NCT00382785|144738814|SUPERIORITY_OR_OTHER|||||||0.315|TWO_SIDED|95.0|||||univariate analysis|||Power calculation indicated that 60 subjects would be needed. Null Hypothesis: There will be no difference in perceived social support based on type of online support group (moderated or peer-led).||||.315
72605487|NCT00382785|144738815|SUPERIORITY_OR_OTHER|||||||0.23||95.0|||||univariate analysis|Null Hypothesis: There will be no difference between the moderated and peer-led groups based on type of online support (moderated; peer-led)||Power analysis indicated that 60 subjects were needed. Null hypothesis: There will be no difference in depressive symptoms based on type of online support group (moderated or peer-led).||||.23
72605488|NCT00382785|144738816|SUPERIORITY_OR_OTHER|||||||0.32|TWO_SIDED|95.0|||||Univariate Analysis|||Power analysis indicated that 60 subjects were needed. Null hypothesis: There will be no difference in quality of life (QOL) based on type of online support group (moderated or peer-led).||||.32
72605489|NCT01705977|144738823|OTHER||Difference in percentage versus placebo|0.1|||||TWO_SIDED|95.0|-0.31|0.51|||||95% Confidence Interval was calculated using simple asymptotic Chi-Square (Pearson) method.|||0.51|-0.31|
72605490|NCT01705977|144738824|OTHER||Difference in percentage versus placebo|-0.35|||||TWO_SIDED|95.0|-1.55|0.85|||||95% CI for serious infections was calculated using simple asymptotic Chi-Square (Pearson) method.|||0.85|-1.55|
72605491|NCT01705977|144738824|OTHER||Difference in percentage versus placebo|-0.7|||||TWO_SIDED|95.0|-1.6|0.2|||||95% CI for opportunistic infections and other infections of interest (serious and non-serious) was calculated using simple asymptotic Chi-Square (Pearson) method.|||0.20|-1.60|
72605492|NCT01705977|144738824|OTHER||Difference in percentage versus placebo|0.0|||||TWO_SIDED|95.0|-0.31|0.31|||||95% CI for malignancies (excluding NMSC) was calculated using simple asymptotic Chi-Square (Pearson) method.|||0.31|-0.31|
72605493|NCT01705977|144738824|OTHER||Difference in percentage versus placebo|0.05|||||TWO_SIDED|95.0|-0.21|0.31|||||95% CI for NMSC was calculated using simple asymptotic Chi-Square (Pearson) method.|||0.31|-0.21|
72605494|NCT01705977|144738824|OTHER||Difference in percentage versus placebo|0.3|||||TWO_SIDED|95.0|0.02|0.58|||||95% CI for psychiatric events suggesting serious mood disorders and anxiety (serious depression) was calculated using simple asymptotic Chi-Square (Pearson) method.|||0.58|0.02|
72605495|NCT01705977|144738824|OTHER||Difference in percentage versus placebo|0.26|||||TWO_SIDED|95.0|-0.44|0.96|||||95% CI for suicidality (C-SSRS) was calculated using simple asymptotic Chi-Square (Pearson) method.|||0.96|-0.44|
72605496|NCT01705977|144738824|OTHER||Difference in percentage versus placebo|0.3|||||TWO_SIDED|95.0|-0.01|0.61|||||95% CI for SIHR was calculated using simple asymptotic Chi-Square (Pearson) method.|||0.61|-0.01|
72605497|NCT01705977|144738826|OTHER||Difference in percentage versus placebo|-0.45|||||TWO_SIDED|95.0|-1.03|0.13|||||95% CI was calculated using simple asymptotic Chi-Square (Pearson) method.|||0.13|-1.03|
72605498|NCT01705977|144738827|OTHER||Difference in percentage versus placebo|-0.75|||||TWO_SIDED|95.0|-2.02|0.51|||||95% CI for serious infections was calculated using simple asymptotic Chi-Square (Pearson) method.|||0.51|-2.02|
72605499|NCT01705977|144738827|OTHER||Difference in percentage versus placebo|-1.0|||||TWO_SIDED|95.0|-1.96|-0.04|||||95% CI for opportunistic infections and other infections of interest (serious and non-serious) was calculated using simple asymptotic Chi-Square (Pearson) method.|||-0.04|-1.96|
72605500|NCT01705977|144738827|OTHER||Difference in percentage versus placebo|-0.1|||||TWO_SIDED|95.0|-0.44|0.24|||||95% CI for malignancies (excluding NMSC) was calculated using simple asymptotic Chi-Square (Pearson) method.|||0.24|-0.44|
72605501|NCT01705977|144738827|OTHER||Difference in percentage versus placebo|0.05|||||TWO_SIDED|95.0|-0.21|0.31|||||95% CI for NMSC was calculated using simple asymptotic Chi-Square (Pearson) method.|||0.31|-0.21|
72605502|NCT01705977|144738827|OTHER||Difference in percentage versus placebo|0.3|||||TWO_SIDED|95.0|0.02|0.58|||||95% CI for psychiatric events suggesting serious mood disorders and anxiety (serious depression) was calculated using simple asymptotic Chi-Square (Pearson) method.|||0.58|0.02|
72605503|NCT01705977|144738827|OTHER||Difference in percentage versus placebo|0.31|||||TWO_SIDED|95.0|-0.42|1.05|||||95% CI for suicidality (C-SSRS) was calculated using simple asymptotic Chi-Square (Pearson) method.|||1.05|-0.42|
72605504|NCT01705977|144738827|OTHER||Difference in percentage versus placebo|0.3|||||TWO_SIDED|95.0|-0.01|0.61|||||95% CI for SIHR was calculated using simple asymptotic Chi-Square (Pearson) method.|||0.61|-0.01|
72605505|NCT01705977|144738829|OTHER||Odds ratio versus placebo|1.3||||0.0284|TWO_SIDED|95.0|1.03|1.65|||Regression, Logistic||95% CI and P-value was calculated from a logistic regression model for the comparison between belimumab and placebo including treatment group, Baseline prednisone dose, screening SELENA SLEDAI score (\<=9 versus \>=10) and region|||1.65|1.03|0.0284
72605506|NCT03066830|144738832|SUPERIORITY||Difference in Least Square (LS) Mean|-0.76|STANDARD_ERROR_OF_MEAN|0.095|<|0.0001|TWO_SIDED|95.0|-0.946|-0.574|||ANCOVA|||The change from baseline to Week 26 is analyzed using ANCOVA model with treatment groups randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of Metformin use at screening, randomization strata of mean SBP (\<130, ≥130 mmHg) at screening, and country as fixed effects, and baseline HbA1c as a covariate.||-0.574|-0.946|< 0.0001
72605507|NCT03066830|144738833|SUPERIORITY||Difference in LS Means|-1.608|STANDARD_ERROR_OF_MEAN|0.286|<|0.0001|TWO_SIDED|95.0|-2.1685|-1.0471|||ANCOVA|||The change from baseline to Week 26 is analyzed using ANCOVA model with treatment groups randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of Metformin use at screening, randomization strata of mean SBP (\<130, ≥130 mmHg) at screening, and country as fixed effects, and baseline fasting plasma glucose as a covariate.||-1.0471|-2.1685|< 0.0001
72605508|NCT03066830|144738834|SUPERIORITY||Difference in LS Means|-0.82|STANDARD_ERROR_OF_MEAN|1.272||0.5172|TWO_SIDED|95.0|-3.316|1.669|||ANCOVA|||The change from baseline to Week 12 is analyzed using ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of Metformin use at screening and country as fixed effects, and baseline SBP as a covariate.||1.669|-3.316|0.5172
72605509|NCT03066830|144738835|SUPERIORITY||Difference in LS Means|-1.02|STANDARD_ERROR_OF_MEAN|0.983||0.2994|TWO_SIDED|95.0|-2.946|0.907|||ANCOVA|||The change from baseline to Week 12 is analyzed using ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of Metformin use at screening, randomization strata of mean SBP (\<130, ≥ 30 mmHg) at screening, and country as fixed effects, and baseline SBP as a covariate.||0.907|-2.946|0.2994
72605510|NCT03066830|144738836|SUPERIORITY||Difference in LS Means|-1.41|STANDARD_ERROR_OF_MEAN|0.267|<|0.0001|TWO_SIDED|95.0|-1.932|-0.884|||ANCOVA|||The change from baseline to Week 26 is analyzed using ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of Metformin use at screening, randomization strata of mean SBP (\<130, ≥130 mmHg) at screening, and country as fixed effects, and baseline weight as a covariate.||-0.884|-1.932|< 0.0001
72605511|NCT03066830|144738837|SUPERIORITY||Percentage difference|6.7||||0.0004|TWO_SIDED|95.0|3.03|10.47|||Cochran-Mantel-Haenszel|||Percentage difference between treatment groups using the Cochran-Mantel-Haenszel test stratified by the randomization strata of HbA1c (≤ 8.5, \>8.5%) at screening, randomization strata of mean SBP (\<130,≥130 mmHg) at screening, randomization strata of metformin use at the screening. Missing data at Week 26 were assigned a status of non-responder in the analysis.||10.47|3.03|0.0004
72605512|NCT03066830|144738838|SUPERIORITY||Percentage difference|17.4|||<|0.0001|TWO_SIDED|95.0|11.16|23.73|||Cochran-Mantel-Haenszel|||Percentage difference between treatment groups using the Cochran-Mantel-Haenszel test stratified by the randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of mean SBP (\<130, ≥130 mmHg) at screening, randomization strata of Metformin use at screening. Missing data at Week 26 were assigned a status of non-responder in the analysis.||23.73|11.16|< 0.0001
72605513|NCT00808067|144738871|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.77||||0.0055|TWO_SIDED|95.0|0.64|0.93|||Regression, Cox|||||0.93|0.64|0.0055
72605514|NCT00808067|144738878|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.09||||0.5119|TWO_SIDED|95.0|0.84|1.42|||Regression, Cox|||||1.42|0.84|0.5119
72605515|NCT00808067|144738879|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.1||||0.2371|TWO_SIDED|95.0|0.94|1.29|||Regression, Cox|||||1.29|0.94|0.2371
72605516|NCT00808067|144738880|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.06||||0.5052|TWO_SIDED|95.0|0.89|1.27|||Regression, Cox|||||1.27|0.89|0.5052
72605517|NCT00808067|144738881|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.93||||0.2241||95.0|0.82|1.05|||Regression, Cox|||||1.05|0.82|0.2241
72416276|NCT01972841|144343312|SUPERIORITY||Standard Error of the Mean|0.73|STANDARD_ERROR_OF_MEAN|0.12||0.008|TWO_SIDED|95.0|0.58|0.92|||Negative binomial regression|||Rate ratio of number of incontinence episodes during the 7-day diary between the given combination group and the given monotherapy group calculated from a negative binomial regression model incl. treatment group, sex, age group (\<65, \>=65 years), geographic region and previous OAB medication (yes, no) as factors, baseline log(number of pads used divided by number of valid diary days) included as a covariate and postbaseline number of valid diary days as offset variable.||0.92|0.58|0.008
72605518|NCT00418028|144738904|NON_INFERIORITY_OR_EQUIVALENCE|"If we assume that the non-inferiority level is up to 15% lower (equivalent to a median progression-free time of 3 months), for a one-sided error α=0.05, and 80% power, are necessary 88 patients per group.~Considering an dropout rate of around 10%, the number of patients would be 98 per group."|Hazard Ratio (HR)|1.3||||0.1224|TWO_SIDED|95.0|0.9|1.7|||Log Rank|||||1.7|0.9|0.1224
72605519|NCT00418028|144738905|SUPERIORITY|||||||0.8269|||||||Chi-squared|||||||0.8269
72605520|NCT00418028|144738906|SUPERIORITY||Hazard Ratio (HR)|1.18||||0.5703|TWO_SIDED|95.0|0.67|2.07|||Log Rank|||||2.07|0.67|0.5703
72605521|NCT00418028|144738907|SUPERIORITY||Hazard Ratio (HR)|1.12||||0.4676|TWO_SIDED|95.0|0.83|1.5|||Log Rank|||||1.50|0.83|0.4676
72605522|NCT00418028|144738908|SUPERIORITY||Hazard Ratio (HR)|0.91||||0.5688|TWO_SIDED|95.0|0.66|1.25|||Log Rank|||||1.25|0.66|0.5688
72605523|NCT00418028|144738909|SUPERIORITY|||||||0.4984|||||||Chi-squared|||||||0.4984
72605524|NCT00418028|144738910|SUPERIORITY||Hazard Ratio (HR)|1.2||||0.2556|TWO_SIDED|95.0|0.88|1.63|||Log Rank|||||1.63|0.88|0.2556
72605525|NCT00490971|144738913|SUPERIORITY_OR_OTHER|||||||0.017||95.0||||The two treatment groups were compared using a weighted z-statistic based on rho-family of alpha spending function at information fraction of 85.0% at interim analysis analysis (rho=2.5) at 0.025 (1-sided) level. One-sided alpha at final was 0.0195.|Weighted Z- test|||Null hypothesis: there is no difference between Pali/Pali and Pali/Placebo in the time to recurrence of any mood symptoms related to bipolar I disorder. An interim analysis was performed when approximately 85% of the required number of recurrences were reported in Pali/Pali and Pali/Placebo treatment groups. A flexible group-sequential approach was adopted. The general family of alpha spending function based on the rho-family with rho=2.5 at overall type I error of 0.025 (1-sided) was employed.||||0.017
72605526|NCT00490971|144738914|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The two treatment groups were compared using a weighted z-statistic based on rho-family of alpha spending function at information fraction of 81.9% at interim analysis analysis (rho=2.5) at 0.025 (1-sided) level. One-sided alpha at final was 0.0198.|Weighted z-test|||At the time of interim analysis of the primary efficacy endpoint, the proportion of recurrence of manic symptoms was 81.9% of the number of recurrence of manic symptoms at final analysis. A flexible group-sequential approach was adopted. The general family of alpha spending function based on the rho-family with rho=2.5 at overall type I error of 0.025 (1-sided) was employed.||||<0.001
72605527|NCT00490971|144738915|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.88|||||TWO_SIDED|95.0|0.53|1.46||Cox proportional hazards regression was performed with treatment (Pali/Placebo, Pali/Pali) as a factor. The 2 treatment groups were compared by means of a hazard ratio (Pali/Placebo: Pali/Pali)|Regression, Cox|The percent of participants who reported recurrence of depressive symptoms was: 18% Pali/Placebo, 24% Pali/Pali.|Hazard ratio was estimated with Pali/Placebo in the numerator and Pali/Pali in the denominator|||1.46|0.53|
72605528|NCT00490971|144738916|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.5|||<|0.001|TWO_SIDED|95.0|-6.92|-1.98|||ANCOVA|ANCOVA model with treatment group (Pali/Pali, Pali/Placebo) and country as factors with baseline value as covariate||Change from Baseline (Maintenance Phase) to Endpoint (Maintenance Phase)||-1.98|-6.92|<0.001
72605529|NCT00490971|144738917|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3||||0.763|TWO_SIDED|95.0|-1.87|2.55|||ANCOVA|ANCOVA Model with treatment (Pali/Pali, Pali/Placebo) and country as factors with baseline value as covariate||Change from Baseline (Maintenance Phase) to Endpoint (Maintenance Phase)||2.55|-1.87|0.763
72605530|NCT00490971|144738918|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.7||||0.01|TWO_SIDED|95.0|1.4|10.09|||ANCOVA|ANCOVA Model with treatment (Pali/Pali, Pali/Placebo) and country as factors with baseline value as covariate||Change from Baseline (Maintenance Phase) to Endpoint (Maintenance Phase)||10.09|1.40|0.010
72605531|NCT00490971|144738919|SUPERIORITY_OR_OTHER|||||||0.007||95.0|||||ANCOVA|ANCOVA Model on ranks with treatment (Pali/Pali, Pali/Placebo) and country as factors with baseline value as covariate||Change from Baseline (Maintenance Phase) to Endpoint (Maintenance Phase)||||0.007
72605532|NCT00078403|144738968|SUPERIORITY_OR_OTHER_LEGACY|||||||0.58||||||P-value is pre-specified 1-sided test that PEG slows liver fibrosis progression. Accrual and follow-up on Arms A and B were halted at interim review for lack of fibrosis progression in Arm B (control arm). P-value is unadjusted for interim analysis.|Exact Wilcoxon rank sum test|||Accrual and follow-up on Arms A and B were halted for futility at the first independent interim review of the primary endpoint conducted on May 2, 2007.||||0.58
72605533|NCT02291029|144738986|SUPERIORITY||Mean Difference (Net)|-0.41||||0.397|TWO_SIDED|95.0|-3.7|2.89||One-sided p-value|Repeated measures model|with time (as nominal study week), the interaction between time and treatment (all as fixed effects) and with baseline as a covariate||||2.89|-3.70|0.397
72605534|NCT02291029|144738986|SUPERIORITY||Mean Difference (Net)|-5.21||||0.009|TWO_SIDED|95.0|-9.46|-0.96||One-sided p-value|Repeated measures model|with time (as nominal study week), the interaction between time and treatment (all as fixed effects) and with baseline as a covariate.||||-0.96|-9.46|0.009
72605535|NCT02291029|144738986|SUPERIORITY||Mean Difference (Net)|2.34||||0.344|TWO_SIDED|95.0|-2.78|7.45||two-sided p-value|Repeated measures model|with time (as nominal study week), the interaction between time and treatment (all as fixed effects) and with baseline as a covariate.||||7.45|-2.78|0.344
72605536|NCT02291029|144738987|SUPERIORITY||Mean Difference (Net)|-1.09||||0.205|TWO_SIDED|95.0|-2.97|0.8|||Repeated measures model|with time (as nominal study week), the interaction between time and treatment (all as fixed effects) and with baseline as a covariate||||0.80|-2.97|0.205
72605537|NCT02291029|144738987|SUPERIORITY||Mean Difference (Net)|-0.95||||0.188|TWO_SIDED|95.0|-2.41|0.5|||Repeated measures model|with time (as nominal study week), the interaction between time and treatment (all as fixed effects) and with baseline as a covariate||||0.50|-2.41|0.188
72605538|NCT02291029|144738987|SUPERIORITY||Mean Difference (Net)|-0.37||||0.663|TWO_SIDED|95.0|-2.08|1.35|||Repeated measures model|with time (as nominal study week), the interaction between time and treatment (all as fixed effects) and with baseline as a covariate||||1.35|-2.08|0.663
72605539|NCT02291029|144738988|SUPERIORITY||Mean Difference (Net)|-15.26||||0.161|TWO_SIDED|95.0|-37.9|7.38|||Repeated measures model|with time (as nominal study week), the interaction between time and treatment (all as fixed effects) and with baseline as a covariate||||7.38|-37.90|0.161
72605540|NCT02291029|144738988|SUPERIORITY||Mean Difference (Net)|-12.16||||0.017|TWO_SIDED|95.0|-21.94|-2.38|||Repeated measures model|with time (as nominal study week), the interaction between time and treatment (all as fixed effects) and with baseline as a covariate||||-2.38|-21.94|0.017
72605541|NCT02291029|144738989|SUPERIORITY||Mean Difference (Net)|-9.45||||0.456|TWO_SIDED|95.0|-36.2|17.3|||Repeated measures model|with time (as nominal study week), the interaction between time and treatment (all as fixed effects) and with baseline as a covariate||||17.30|-36.20|0.456
72605542|NCT02291029|144738989|SUPERIORITY||Mean Difference (Net)|-8.14||||0.376|TWO_SIDED|95.0|-26.67|10.39|||Repeated measures model|with time (as nominal study week), the interaction between time and treatment (all as fixed effects) and with baseline as a covariate||||10.39|-26.67|0.376
72605543|NCT02291029|144738990|SUPERIORITY||Mean Difference (Net)|-5.5||||0.172|TWO_SIDED|95.0|-13.91|2.91|||Repeated measures model|with time (as nominal study week), the interaction between time and treatment (all as fixed effects) and with baseline as a covariate||||2.91|-13.91|0.172
72605544|NCT02291029|144738990|SUPERIORITY||Mean Difference (Net)|3.83||||0.175|TWO_SIDED|95.0|-1.81|9.48|||Repeated measures model|with time (as nominal study week), the interaction between time and treatment (all as fixed effects) and with baseline as a covariate||||9.48|-1.81|0.175
72605545|NCT02291029|144738991|SUPERIORITY||Mean Difference (Net)|-0.07||||0.986|TWO_SIDED|95.0|-8.49|8.35|||Repeated measures model|with time (as nominal study week), the interaction between time and treatment (all as fixed effects) and with baseline as a covariate||||8.35|-8.49|0.986
72605546|NCT02291029|144738991|SUPERIORITY||Mean Difference (Net)|3.83||||0.175|TWO_SIDED|95.0|-1.81|9.48|||Repeated measures model|with time (as nominal study week), the interaction between time and treatment (all as fixed effects) and with baseline as a covariate||||9.48|-1.81|0.175
72605547|NCT02291029|144738992|SUPERIORITY||Mean Difference (Net)|1.34||||0.807|TWO_SIDED|95.0|-10.48|13.15|||Repeated measures model|with time (as nominal study week), the interaction between time and treatment (all as fixed effects) and with baseline as a covariate||||13.15|-10.48|0.807
72605548|NCT02291029|144738992|SUPERIORITY||Mean Difference (Net)|-9.83||||0.074|TWO_SIDED|95.0|-20.66|1.01|||Repeated measures model|with time (as nominal study week), the interaction between time and treatment (all as fixed effects) and with baseline as a covariate||||1.01|-20.66|0.074
72605549|NCT02922153|144738993|SUPERIORITY|||||||0.0223|TWO_SIDED|95.0|||||t-test, 1 sided|One-sided, two-sample t-test.||||||0.0223
72605550|NCT02922153|144738994|SUPERIORITY|||||||0.6259|TWO_SIDED|95.0|||||t-test, 1 sided|One-sided two-sample t-test.||||||0.6259
72605551|NCT02922153|144738994|SUPERIORITY|||||||0.518|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|Wilcoxon two-sample test.||||||0.518
72605552|NCT02922153|144738995|SUPERIORITY|||||||0.0201||||||FEV1 one-sided, two-sample t-test|t-test, 1 sided|||||||0.0201
72605553|NCT02922153|144738995|SUPERIORITY|||||||0.06||||||FVC one-sided, two-sample t-test|t-test, 1 sided|||||||0.06
72605554|NCT02922153|144738995|SUPERIORITY|||||||0.09||||||SVC one-sided, two-sample t-test|t-test, 1 sided|||||||0.09
72605555|NCT02922153|144738996|SUPERIORITY|||||||0.3085||||||72 Hours Post-Op|Wilcoxon (Mann-Whitney)|Wilcoxon rank-sum test||||||0.3085
72605556|NCT02922153|144738996|SUPERIORITY|||||||0.8196||||||96 Hours Post-Op|Wilcoxon (Mann-Whitney)|Wilcoxon rank-sum test.||||||0.8196
72605557|NCT02922153|144738996|SUPERIORITY|||||||0.7269||||||120 Hours Post-Op|Wilcoxon (Mann-Whitney)|Wilcoxon rank-sum test.||||||0.7269
72605558|NCT02922153|144738998|SUPERIORITY|||||||0.4421|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank-sum test||Analysis is the time from end of procedure to oral endotracheal extubation||||0.4421
72605559|NCT02922153|144738999|SUPERIORITY|||||||0.4352||||||Total Post-Procedure for Hospital Stay|Wilcoxon (Mann-Whitney)|Wilcoxon Rank-Sum Test||||||0.4352
72605560|NCT02922153|144739000|SUPERIORITY|||||||0.2939||||||ICU Length of Stay|Wilcoxon (Mann-Whitney)|Wilcoxon rank-sum test||||||0.2939
72605561|NCT02922153|144739000|SUPERIORITY|||||||0.0998||||||Hospital Length of Stay|Wilcoxon (Mann-Whitney)|Wilcoxon rank-sum test||||||0.0998
72605562|NCT02922153|144739001|SUPERIORITY|||||||0.2877|||||||Chi-squared|||48 Hours Post-Op: Patient able to sit up in bed||||0.2877
72605563|NCT02922153|144739001|SUPERIORITY|||||||0.5311|||||||Fisher Exact|||48 Hours Post-Op: Patient able to stand up||||0.5311
72605564|NCT02922153|144739001|SUPERIORITY|||||||0.4908|||||||Fisher Exact|||48 Hours Post-Op: Patient able to walk||||0.4908
72416277|NCT01972841|144343312|SUPERIORITY||Rate ratio|0.8|STANDARD_ERROR_OF_MEAN|0.12||0.069|TWO_SIDED|95.0|0.64|1.02|||Negative binomial regression|||Rate ratio of number of incontinence episodes during the 7-day diary between the given combination group and the given monotherapy group calculated from a negative binomial regression model incl. treatment group, sex, age group (\<65, \>=65 years), geographic region and previous OAB medication (yes, no) as factors, baseline log(number of pads used divided by number of valid diary days) included as a covariate and postbaseline number of valid diary days as offset variable.||1.02|0.64|0.069
72416278|NCT01972841|144343313|SUPERIORITY||Least squares mean difference|-0.04|STANDARD_ERROR_OF_MEAN|0.86||0.958|TWO_SIDED|95.0|-1.73|1.64|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (solifenacin 5 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||1.64|-1.73|0.958
72605565|NCT02922153|144739001|SUPERIORITY|||||||0.8621|||||||Fisher Exact|||48 Hours Post-Op: Right Shoulder Flexion Movement||||0.8621
72605566|NCT02922153|144739001|SUPERIORITY|||||||1|||||||Fisher Exact|||48 Hours Post-Op: Left Shoulder Flexion Movement||||1
72605567|NCT02922153|144739001|SUPERIORITY|||||||0.0133|||||||Fisher Exact|||72 Hours Post-Op: Patient able to sit up in bed||||0.0133
72605568|NCT02922153|144739001|SUPERIORITY|||||||0.0037|||||||Fisher Exact|||72 Hours Post-Op: Patient able to stand up||||0.0037
72605569|NCT02922153|144739001|SUPERIORITY|||||||0.1671|||||||Fisher Exact|||72 Hours Post-Op: Patient able to walk||||0.1671
72605570|NCT02922153|144739001|SUPERIORITY|||||||1|||||||Fisher Exact|||72 Hours Post-Op: Right Shoulder Flexion Movement||||1.000
72605571|NCT02922153|144739001|SUPERIORITY|||||||1|||||||Fisher Exact|||72 Hours Post-Op: Left Shoulder Flexion Movement||||1
72605572|NCT02922153|144739001|SUPERIORITY|||||||1|||||||Fisher Exact|||96 Hours Post-Op: Patient able to sit up in bed||||1
72605573|NCT02922153|144739001|SUPERIORITY|||||||0.2757|||||||Fisher Exact|||96 Hours Post-Op: Patient able to stand up||||0.2757
72605574|NCT02922153|144739001|SUPERIORITY|||||||0.9025|||||||Fisher Exact|||96 Hours Post-Op: Patient able to walk||||0.9025
72605575|NCT02922153|144739001|SUPERIORITY|||||||0.7942|||||||Fisher Exact|||96 Hours Post-Op: Right Shoulder Flexion Movement||||0.7942
72605576|NCT02922153|144739001|SUPERIORITY|||||||1|||||||Fisher Exact|||96 Hours Post-Op: Left Shoulder Flexion Movement||||1
72605577|NCT02922153|144739001|SUPERIORITY|||||||0.3492|||||||Fisher Exact|||120 Hours Post-Op: Patient able to sit up in bed||||0.3492
72605578|NCT02922153|144739001|SUPERIORITY|||||||0.2644|||||||Fisher Exact|||120 Hours Post-Op: Patient able to stand up||||0.2644
72605579|NCT02922153|144739001|SUPERIORITY|||||||0.8258|||||||Fisher Exact|||120 Hours Post-Op: Patient able to walk||||0.8258
72605580|NCT02922153|144739001|SUPERIORITY|||||||0.67|||||||Fisher Exact|||120 Hours Post-Op: Right Shoulder Flexion Movement||||0.67
72605581|NCT02922153|144739001|SUPERIORITY|||||||0.5693|||||||Fisher Exact|||120 Hours Post-Op: Left Shoulder Flexion Movement||||0.5693
72605582|NCT02922153|144739001|SUPERIORITY|||||||0.1189|||||||Chi-squared|||Discharge: Patient able to sit up in bed||||0.1189
72605583|NCT02922153|144739001|SUPERIORITY|||||||1|||||||Fisher Exact|||Discharge: Patient able to stand up||||1
72605584|NCT02922153|144739001|SUPERIORITY|||||||0.6992|||||||Fisher Exact|||Discharge: Patient able to walk||||0.6992
72605585|NCT02922153|144739001|SUPERIORITY|||||||0.4429|||||||Fisher Exact|||Discharge: Right Shoulder Flexion Movement||||0.4429
72605586|NCT02922153|144739001|SUPERIORITY|||||||0.4563|||||||Fisher Exact|||Discharge: Left Shoulder Flexion Movement||||0.4563
72605587|NCT03429348|144739002|SUPERIORITY||Mean Difference (Final Values)|1.18||||9e-07|TWO_SIDED||||||t-test, 2 sided|We are comparing the log transformed values.||||||0.0000009
72605588|NCT03429348|144739002|SUPERIORITY||Mean Difference (Final Values)|1.35||||1.8e-05|TWO_SIDED||||||t-test, 2 sided|We are comparing the log transformed values||||||0.000018
72605589|NCT02692586|144739003|SUPERIORITY|To detect an RV/LV ratio change \> 0.12 with a power of 80% at one-sided alpha = 0.025, the necessary sample size was calculated to be ≥ 52, 31, or 21 patients (to detect RV/LV ratio changes of 0.20, 0.225, or 0.25, respectively).|||||<|0.0001|||||||t-test, 1 sided|||||||< 0.0001
72605590|NCT02692586|144739004|SUPERIORITY|The hypothesized composite MAE rate was expected to be about 13%. The necessary sample size to detect a difference from an expected MAE rate of 13% with 80% power was calculated to be 103 patients (with a one-sided p value = 0.05).|||||<|0.0001|||||||t-test, 1 sided|||||||< 0.0001
72605591|NCT04110314|144739011|SUPERIORITY||Risk Ratio (RR)|1.01|||||TWO_SIDED|95.0|1.0|1.03|||||These results compare the arm receiving a pre-commitment prompt to the arm receiving no pre-commitment prompt.|||1.03|1.00|
72605592|NCT04110314|144739011|SUPERIORITY||Risk Ratio (RR)|1.0|||||TWO_SIDED|95.0|0.99|1.01|||||These results compare the arm receiving a pre-commitment prompt to the arm receiving no pre-commitment prompt.|||1.01|0.99|
72605593|NCT04110314|144739011|SUPERIORITY||Risk Ratio (RR)|1.01|||||TWO_SIDED|95.0|0.99|1.03|||||These results compare the arm receiving a pre-commitment prompt to the arm receiving no pre-commitment prompt.|||1.03|0.99|
72605594|NCT04110314|144739011|SUPERIORITY||Risk Ratio (RR)|1.02|||||TWO_SIDED|95.0|1.0|1.04|||||These results compare the arm receiving a pre-commitment prompt to the arm receiving no pre-commitment prompt.|||1.04|1.00|
72605595|NCT04110314|144739011|SUPERIORITY||Risk Ratio (RR)|0.99|||||TWO_SIDED|95.0|0.98|1.01|||||These results compare the arm receiving gain-framed reminders to the arm receiving no reminders.|||1.01|0.98|
72605596|NCT04110314|144739011|SUPERIORITY||Risk Ratio (RR)|0.99|||||TWO_SIDED|0.95|0.97|1.02|||||These results compare the arm receiving gain-framed reminders to the arm receiving no reminders.|||1.02|0.97|
72605597|NCT04110314|144739011|SUPERIORITY||Risk Ratio (RR)|0.99|||||TWO_SIDED|95.0|0.97|1.01|||||These results compare the arm receiving gain-framed reminders to the arm receiving no reminders.|||1.01|0.97|
72605598|NCT04110314|144739011|SUPERIORITY||Risk Ratio (RR)|1.01|||||TWO_SIDED|95.0|0.98|1.05|||||These results compare the arm receiving gain-framed reminders to the arm receiving no reminders.|||1.05|0.98|
72605599|NCT04110314|144739011|SUPERIORITY||Risk Ratio (RR)|1.01|||||TWO_SIDED|95.0|0.99|1.02|||||These results compare the arm receiving loss-framed reminders to the arm receiving no reminders.|||1.02|0.99|
72605600|NCT04110314|144739011|SUPERIORITY||Risk Ratio (RR)|1.0|||||TWO_SIDED|95.0|0.98|1.02|||||These results compare the arm receiving loss-framed reminders to the arm receiving no reminders.|||1.02|0.98|
72605601|NCT04110314|144739011|SUPERIORITY||Risk Ratio (RR)|0.99|||||TWO_SIDED|95.0|0.97|1.02|||||These results compare the arm receiving loss-framed reminders to the arm receiving no reminders.|||1.02|0.97|
72605602|NCT04110314|144739011|SUPERIORITY||Risk Ratio (RR)|1.02|||||TWO_SIDED|95.0|1.0|1.04|||||These results compare the arm receiving loss-framed reminders to the arm receiving no reminders.|||1.04|1.00|
72605603|NCT01004978|144739088|SUPERIORITY|||||||0.4||||||one-sided p-value|Cochran-Mantel-Haenszel|||||||0.4
72605604|NCT01004978|144739089|SUPERIORITY|||||||0.76|||||||Log Rank|||||||0.76
72605605|NCT01711983|144739098|NON_INFERIORITY|Non-inferiority margin based on 1) the lower 95% confidence bound (= 0.82) for estimated 6-month composite Clinical Success for the historical device (219/253=0.866), and 2) a worst-case analysis of 6-month composite Clinical Success for the historical device (0.81, assuming the 18 subjects with missing echo evaluations were failures).|Risk Difference (RD)|-0.0366|||<|0.0001|ONE_SIDED|95.0||0.007||A priori 1-sided alpha = 0.05.|2-sample binomial proportions test||Difference is control - test. Confidence interval is the upper one-sided 95% Wald confidence interval.|"Test null hypothesis of inferiority of test device (test) compared to historical device (control).~H0: Pc - Pt ≥ Δ vs H1: Pc - Pt \< Δ, where Pt and Pc are true proportions of 6-month clinical success for test and control, respectively, and Δ is the non-inferiority margin.~Given Nc = 253, then Nt = 135 test subjects provides 86% power to reject H0 with 95% confidence if Δ = 0.10 and Pc = Pt = 0.866 under H0."||0.007||<0.0001
72605606|NCT00871234|144739168|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.03||||0.36||95.0|||||Wilcoxon signed-rank|||||||0.36
72605607|NCT01261390|144739249|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.677|STANDARD_ERROR_OF_MEAN|1.652|||TWO_SIDED|95.0|-5.915|0.561|||||Presented average of the treatment effects on 24hr SBP at 6months and 12months: (6mo + 12mo)/ 2; Comparison: ActivePAP Control. Adjusted for randomization factors (CVD; site; sleepstudy type) with subjectspecific slopes and intercepts.|"We conducted a linear mixed effects regression (LMER) to estimate the treatment effect of CPAP on mean 24hour Systolic Blood Pressure (SBP). Timepoint, treatment, and the timepoint\* treatment interaction were included as fixed effects, as were randomization stratification factors. Subject was included as a random effect. Let: y = observed SBP; β = fixed effects; u = random effects; X = known design matrix; Z = vector of subjects~Then our model is:~y = Xβ + Zu + ε"||0.561|-5.915|
72605608|NCT01261390|144739250|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|99.0||||0.003|TWO_SIDED||||||Mixed Models Analysis|Adjusted for intervention and study duration (number of nights), and randomization (CVD; site; diagnostic sleep study type; PAP device type).|Estimated value is minutes of use per night.|We performed a mixed effects analysis of the effect of Motivational Enhancement (ME) on nightly CPAP adherence. Our model included every night of data and adjusted for intervention and study duration (number of nights), as well as randomization stratification factors (CVD; site; diagnostic sleepstudy type; PAP device type).||||0.003
72605609|NCT04346199|144739316|OTHER|No formal hypothesis testing for this endpoint.|Hazard Ratio (HR)|0.758|||||TWO_SIDED|95.0|0.323|1.722||P-value not generated.|Regression, Cox|Adjusting for age (\<65 vs \>=65 years) and comorbidities (present vs absent). Ties handled by Efron approach. HR CI using profile likelihood approach.||||1.722|0.323|
72605610|NCT04346199|144739324|OTHER|No formal hypothesis testing for this endpoint.|Hazard Ratio (HR)|0.967||||||95.0|0.69|1.353|||Regression, Cox|Adjusting for age (\<65 vs \>=65 years) and comorbidities (present vs absent). Ties handled by Efron approach. HR CI using profile likelihood approach.||||1.353|0.690|
72605611|NCT05404711|144739385|OTHER||AUC|0.56|||||TWO_SIDED|95.0|0.18|0.94|||||Area under the receiver operating characteristic curve (AUC) was 0.56 (95% CI 0.18-0.94) for 2-hour postprandial glucose.|||0.94|0.18|
72605612|NCT05404711|144739386|OTHER||AUC|0.56|||||TWO_SIDED|95.0|0.18|0.94|||||Area under the receiver operating characteristic curve (AUC) was 0.56 (95% CI 0.18-0.94) for 2-hour postprandial glucose.|||0.94|0.18|
72605613|NCT05404711|144739387|OTHER||AUC|0.56|||||TWO_SIDED|95.0|0.18|0.94|||||Area under the receiver operating characteristic curve (AUC) was 0.56 (95% CI 0.18-0.94) for 2-hour postprandial glucose.|||0.94|0.18|
72605614|NCT05404711|144739388|OTHER||AUC|0.56|||||TWO_SIDED|95.0|0.18|0.94|||||Area under the receiver operating characteristic curve (AUC) was 0.56 (95% CI 0.18-0.94) for 2-hour postprandial glucose.|||0.94|0.18|
72605615|NCT05404711|144739389|OTHER||AUC|1.0|||||TWO_SIDED||||||||Area under the receiver operating characteristic curve (AUC) was 1.00 (based on 100% sensitivity) for elevated fasting glucose.|||||
72605616|NCT05404711|144739390|OTHER||AUC|1.0|||||TWO_SIDED||||||||Area under the receiver operating characteristic curve (AUC) was 1.00 (based on 100% sensitivity) for elevated fasting glucose.|||||
72605617|NCT05404711|144739391|OTHER||AUC|1.0|||||TWO_SIDED||||||||Area under the receiver operating characteristic curve (AUC) was 1.00 (based on 100% sensitivity) for elevated fasting glucose.|||||
72605618|NCT05404711|144739392|OTHER||AUC|1.0|||||TWO_SIDED||||||||Area under the receiver operating characteristic curve (AUC) was 1.00 (based on 100% sensitivity) for elevated fasting glucose.|||||
72605619|NCT05404711|144739393|OTHER|Spearman correlation analysis|Spearman correlation rho|0.18||||0.3|TWO_SIDED||||||Spearman correlation|||Correlation analyses were performed to assess the relationship between home-OGTT fasting glucose and HbA1c.||||0.3
72605620|NCT05404711|144739393|OTHER|Spearman correlation analysis|Spearman correlation rho|0.5||||0.005|TWO_SIDED||||||Spearman correlation|||Correlation analyses were performed to assess the relationship between home-OGTT 2-hour glucose and HbA1c.||||0.005
72416279|NCT01972841|144343313|SUPERIORITY||Least squares mean difference|-0.58|STANDARD_ERROR_OF_MEAN|0.86||0.5|TWO_SIDED|95.0|-2.27|1.11|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (solifenacin 5 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||1.11|-2.27|0.500
72416280|NCT01972841|144343313|SUPERIORITY||Least squares mean difference|-1.91|STANDARD_ERROR_OF_MEAN|0.87||0.028|TWO_SIDED|95.0|-3.62|-0.2|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (mirabegron 25 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||-0.20|-3.62|0.028
72605621|NCT05404711|144739393|OTHER|Spearman correlation analysis|Spearman correlation rho|0.46||||0.01|TWO_SIDED||||||Spearman correlation|||Correlation analyses were performed to assess the relationship between delta (difference between fasting and postprandial) home-OGTT glucose and HbA1c.||||0.01
72605622|NCT05404711|144739393|OTHER|Spearman correlation analysis|Spearman correlation rho|0.23||||0.2|TWO_SIDED||||||Spearman correlation|||Correlation analyses were performed to assess the relationship between home-OGTT peak glucose and HbA1c.||||0.2
72605623|NCT05404711|144739393|OTHER|Spearman correlation analysis|Spearman correlation rho|0.14||||0.5|TWO_SIDED||||||Spearman correlation|||Correlation analyses were performed to assess the relationship between time of home-OGTT peak glucose and HbA1c.||||0.5
72416281|NCT01972841|144343313|SUPERIORITY||Least squares mean difference|-1.41|STANDARD_ERROR_OF_MEAN|0.88||0.108|TWO_SIDED|95.0|-3.13|0.31|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (mirabegron 50 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||0.31|-3.13|0.108
72605624|NCT05404711|144739393|OTHER|Spearman correlation analysis|Spearman correlation rho|0.29||||0.1|TWO_SIDED||||||Spearman correlation|||Correlation analyses were performed to assess the relationship between CGM mean glucose (mg/dL) and HbA1c.||||0.1
72605625|NCT05404711|144739393|OTHER|Spearman correlation analysis|Spearman correlation rho|-0.15||||0.4|TWO_SIDED||||||Spearman correlation|||Correlation analyses were performed to assess the relationship between CGM correlation of variability (CV) and HbA1c.||||0.4
72605626|NCT05404711|144739393|OTHER|Spearman correlation analysis|Spearman correlation rho|-0.06||||0.7|TWO_SIDED||||||Spearman correlation|||Correlation analyses were performed to assess the relationship between CGM standard deviation and HbA1c.||||0.7
72605627|NCT05404711|144739394|OTHER|Spearman correlation analysis|Spearman correlation rho|0.25||||0.2|TWO_SIDED||||||Spearman correlation|||Correlation analyses were performed to assess the relationship between home-OGTT fasting glucose and laboratory-OGTT fasting glucose.||||0.2
72605628|NCT05404711|144739394|OTHER|Spearman correlation analysis|Spearman correlation rho|0.19||||0.3|TWO_SIDED||||||Spearman correlation|||Correlation analyses were performed to assess the relationship between home-OGTT 2-hour glucose and lab-OGTT fasting glucose.||||0.3
72605629|NCT05404711|144739394|OTHER|Spearman correlation analysis|Spearman correlation rho|-0.1||||0.6|TWO_SIDED||||||Spearman correlation|||Correlation analyses were performed to assess the relationship between delta (difference between fasting and postprandial) home-OGTT and lab-OGTT fasting glucose.||||0.6
72605630|NCT05404711|144739394|OTHER|Spearman correlation analysis|Spearman correlation rho|0.19||||0.3|TWO_SIDED||||||Spearman correlation|||Correlation analyses were performed to assess the relationship between home-OGTT peak glucose and lab-OGTT fasting glucose.||||0.3
72605631|NCT05404711|144739394|OTHER|Spearman correlation analysis|Spearman correlation rho|0.09||||0.6|TWO_SIDED||||||Spearman correlation|||Correlation analyses were performed to assess the relationship between time of home-OGTT peak glucose and lab-OGTT fasting glucose.||||0.6
72605632|NCT05404711|144739394|OTHER|Spearman correlation analysis|Spearman correlation rho|0.35||||0.05|TWO_SIDED||||||Spearman correlation|||Correlation analyses were performed to assess the relationship between CGM mean glucose and lab-OGTT fasting glucose.||||0.05
72605633|NCT05404711|144739394|OTHER|Spearman correlation analysis|Spearman correlation rho|-0.18||||0.3|TWO_SIDED||||||Spearman correlation|||Correlation analyses were performed to assess the relationship between CGM coefficient of variability (CV) and lab-OGTT fasting glucose.||||0.3
72605634|NCT05404711|144739394|OTHER|Spearman correlation analysis|Spearman correlation rho|-0.07||||0.7|TWO_SIDED||||||Spearman correlation|||Correlation analyses were performed to assess the relationship between CGM standard deviation (SD) and lab-OGTT fasting glucose.||||0.7
72605635|NCT05404711|144739395|OTHER|Spearman correlation analysis|Spearman correlation rho|0.1||||0.6|TWO_SIDED||||||Spearman correlation|||Correlation analyses were performed to assess the relationship between home-OGTT fasting glucose and lab-OGTT 2-hour glucose.||||0.6
72605636|NCT05404711|144739395|OTHER|Spearman correlation analysis|Spearman correlation rho|0.31||||0.1|TWO_SIDED||||||Spearman correlation|||Correlation analyses were performed to assess the relationship between home-OGTT 2-hour glucose and lab-OGTT 2-hour glucose.||||0.1
72605637|NCT05404711|144739395|OTHER|Spearman correlation analysis|Spearman correlation rho|0.25||||0.2|TWO_SIDED||||||Spearman correlation|||Correlation analyses were performed to assess the relationship between delta (difference between fasting and postprandial) home-OGTT glucose and lab-OGTT 2-hour glucose.||||0.2
72605638|NCT05404711|144739395|OTHER|Spearman correlation analysis|Spearman correlation rho|0.26||||0.2|TWO_SIDED||||||Spearman correlation|||Correlation analyses were performed to assess the relationship between home-OGTT peak glucose and lab-OGTT 2-hour glucose.||||0.2
72605639|NCT05404711|144739395|OTHER|Spearman correlation analysis|Spearman correlation rho|0.27||||0.2|TWO_SIDED||||||Spearman correlation|||Correlation analyses were performed to assess the relationship between time of home-OGTT peak glucose and lab-OGTT 2-hour glucose.||||0.2
72605640|NCT05404711|144739395|OTHER|Spearman correlation analysis|Spearman correlation rho|0.31||||0.08|TWO_SIDED||||||Spearman correlation|||Correlation analyses were performed to assess the relationship between CGM mean glucose and lab-OGTT 2-hour glucose.||||0.08
72605641|NCT05404711|144739395|OTHER|Spearman correlation analysis|Spearman correlation rho|0.15||||0.4|TWO_SIDED||||||Spearman correlation|||Correlation analyses were performed to assess the relationship between CGM coefficient of variability (CV) and lab-OGTT 2-hour glucose.||||0.4
72605642|NCT05404711|144739395|OTHER|Spearman correlation analysis|Spearman correlation rho|0.28||||0.1|TWO_SIDED||||||Spearman correlation|||Correlation analyses were performed to assess the relationship between CGM standard deviation (SD) and lab-OGTT 2-hour glucose.||||0.1
72605643|NCT03430856|144739446|NON_INFERIORITY|Change from baseline in HbA1c at 24 weeks of treatment, was analyzed using mixed model for repeated measures (MMRM) where all available post-baseline HbA1c measurements obtained up to Week 24 was entered as the dependent variables; visit and treatment were included as fixed factors, with Baseline HbA1c and stratification factor variables as covariates. Furthermore, the interaction terms of visit by treatment, visit by stratification factors and visit by Baseline HbA1c were included in the model.|Mean Difference (Net)|0.99|||||TWO_SIDED|95.0|0.502|1.47|||||Insulin Tregopil 45 mg - Insulin Aspart|||1.470|0.502|
72605644|NCT03430856|144739446|NON_INFERIORITY|Non inferiority margin is 0.4%|Mean Difference (Net)|0.89|||||TWO_SIDED|95.0|0.414|1.37|||||Insulin Tregopil 30mg - Insulin Aspart|||1.370|0.414|
72605645|NCT02002871|144739465|SUPERIORITY_OR_OTHER|||||||0.0152|TWO_SIDED||||||t-test, 2 sided|||The statistical analysis was performed on the difference of the change from baseline of the Blue light treated plaque versus the Control plaque.||||0.0152
72605646|NCT04265261|144739498|SUPERIORITY||Risk Difference (RD)|1.19||||0.8586|TWO_SIDED|95.0|-11.86|14.23|||Cochran-Mantel-Haenszel|||||14.23|-11.86|0.8586
72605647|NCT04265261|144739498|SUPERIORITY||Risk Difference (RD)|-2.93||||0.6388|TWO_SIDED|95.0|-15.18|9.31|||Cochran-Mantel-Haenszel|||||9.31|-15.18|0.6388
72605648|NCT03877224|144739503|SUPERIORITY||Hodges-Lehmann median diff. vs placebo|3.16||||0.07905|TWO_SIDED|95.0|0.36|6.01||To account for multiplicity, a pre-specified testing strategy was followed to control the overall type I error rate.|Rank ANCOVA|The model includes rank-based baseline, weeks impacted by COVID-19 and treatment group as covariates and is stratified by T2DM status at randomization||For the primary efficacy endpoint KCCQ-TSS, the following hypothesis was tested using the significance level 0.04990 • H0: m(r(A)) = m(r(C)) versus • H1: m(r(A)) ≠ m(r(C)) Where H0 and H1 are the null and alternative hypotheses, respectively, and m(r(A)) and m(r(C)) represent the median of the ranked changes in the primary efficacy endpoint, KCCQ-TSS, from baseline to week 16, among patients receiving dapagliflozin (Active) and placebo (Control) treatment, respectively.||6.01|0.36|0.07905
72605649|NCT03877224|144739504|SUPERIORITY||Hodges-Lehmann median diff. vs placebo|3.12||||0.23215|TWO_SIDED|95.0|-0.09|5.37||To account for multiplicity, a pre-specified testing strategy was followed to control the overall type I error rate.|Rank ANCOVA|The model includes rank-based baseline, weeks impacted by COVID-19 and treatment group as covariates and is stratified by T2DM status at randomization||For the primary efficacy endpoint KCCQ-PLS, the following hypothesis was tested at significant level of 0.00005 • H0: m(r(A)) = m(r(C)) versus • H1: m(r(A)) ≠ m(r(C)) Where H0 and H1 are the null and alternative hypotheses, respectively, and m(r(A)) and m(r(C)) represent the median of the ranked changes in the primary efficacy endpoint, KCCQ-PLS, from baseline to week 16, among patients receiving dapagliflozin (Active) and placebo (Control) treatment, respectively.||5.37|-0.09|0.23215
72605650|NCT03877224|144739505|SUPERIORITY||Hodges-Lehmann median diff. vs placebo|1.6||||0.66801|TWO_SIDED|95.0|-5.9|9.0||To account for multiplicity, a pre-specified testing strategy was followed to control the overall type I error rate.|Rank ANCOVA|The model includes rank-based baseline, treatment group as covariates and is stratified by T2DM status at randomization||For the primary efficacy endpoint 6MWD, the following hypothesis was tested using the significance level 0.00005: H0: m(r(A)) = m(r(C)) versus H1: m(r(A)) ≠ m(r(C)) Where H0 and H1 are the null and alternative hypotheses, respectively, and m(r(A)) and m(r(C)) represent the median of the ranked changes in the primary efficacy endpoint, 6MWD, from baseline to week 16, among patients receiving dapagliflozin (Active) and placebo (Control) treatment, respectively.||9.0|-5.9|0.66801
72605651|NCT03877224|144739506|SUPERIORITY|Total time spent in LVPA was not tested for statistical significance and the p-value is considered nominal because the test for 6MWD was not statistically significant.|Hodges-Lehmann median diff. vs placebo|0.19||||0.12523|TWO_SIDED|95.0|-0.06|0.48|||Rank ANCOVA|Model includes baseline rank of outcome variable as a covariate, treatment group as a factor, and is stratified by T2DM status at randomization.||For the secondary efficacy endpoint, total time spent in LVPA, the testing hypothesis is • H0: m(r(A)) = m(r(C)) versus • H1: m(r(A)) ≠ m(r(C)) Where H0 and H1 are the null and alternative hypotheses, respectively, and m(r(A)) and m(r(C)) represent the median of the ranked changes in secondary efficacy endpoint, total time spent in LVPA, from baseline to End of study among patients receiving dapagliflozin (Active) and placebo (Control) treatment, respectively.||0.48|-0.06|0.12523
72605652|NCT04754542|144739507|NON_INFERIORITY|We performed a non-inferiority test for the proportions of the drug continuation and drug discontinuation arms experiencing a new MS relapse and/or MRI Brain Lesion over the course of the study duration. The non-inferiority margin used was 8%.|Difference in proportion|0.0121||||0.124|TWO_SIDED|95.0|-0.1321|0.1287|||Exact binomial test|Exact binomial test fr difference in two proportions||We tested the null hypothesis of inferiority with the proportion of disease events (i.e., new MS relapse and/or MRI brain lesion) for the drug discontinuation group being 8% greater than the proportion for the drug continuation group under the alternative that the two rates are equal.||0.1287|-0.1321|0.124
72605653|NCT04754542|144739508|SUPERIORITY|||||||0.639|||||||t-test, 2 sided|||||||0.639
72605654|NCT04754542|144739509|SUPERIORITY|||||||0.964|||||||t-test, 2 sided|||||||0.964
72605655|NCT04754542|144739510|SUPERIORITY|||||||0.819|||||||t-test, 2 sided|||||||0.819
72605656|NCT04754542|144739511|SUPERIORITY|||||||0.515|||||||t-test, 2 sided|||||||0.515
72605657|NCT04754542|144739512|SUPERIORITY|||||||0.388|||||||t-test, 2 sided|||||||0.388
72605658|NCT04754542|144739513|SUPERIORITY|||||||0.183|||||||t-test, 2 sided|||||||0.183
72605659|NCT04754542|144739514|SUPERIORITY|||||||0.414|||||||t-test, 2 sided|||||||0.414
72605660|NCT04754542|144739515|SUPERIORITY|||||||0.998|||||||t-test, 2 sided|||||||0.998
72605661|NCT04754542|144739516|SUPERIORITY|||||||0.32|||||||t-test, 2 sided|||||||0.320
72605662|NCT04754542|144739517|SUPERIORITY|||||||0.061|||||||t-test, 2 sided|||||||0.061
72605663|NCT04754542|144739518|SUPERIORITY|||||||0.032|||||||t-test, 2 sided|||||||0.032
72605664|NCT04754542|144739519|SUPERIORITY|||||||0.514|||||||t-test, 2 sided|||||||0.514
72605665|NCT04754542|144739520|SUPERIORITY|||||||0.017|||||||t-test, 2 sided|||||||0.017
72605666|NCT04754542|144739521|SUPERIORITY|||||||0.155|||||||t-test, 2 sided|||||||0.155
72605667|NCT04754542|144739522|SUPERIORITY|||||||0.358|||||||t-test, 2 sided|||||||0.358
72605668|NCT04754542|144739523|SUPERIORITY|||||||0.151|||||||t-test, 2 sided|||||||0.151
72605669|NCT04754542|144739524|SUPERIORITY|||||||0.123|||||||t-test, 2 sided|||||||0.123
72605670|NCT04754542|144739525|SUPERIORITY|||||||0.656|||||||Chi-squared|||||||0.656
72605671|NCT04754542|144739526|SUPERIORITY|||||||0.892|||||||Chi-squared|||||||0.892
72605672|NCT04754542|144739527|SUPERIORITY|||||||0.063|||||||Mantel Haenszel|Cochran-Mantel-Haenszel chi-square test for ordinal-nominal association was used||||||0.063
72605673|NCT01116921|144739559|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.3||||0.006|TWO_SIDED|95.0|0.13|0.7|||Regression, Logistic|||||0.70|0.13|0.006
72605674|NCT00735709|144739588|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.93|||<|0.001|TWO_SIDED|95.0|-6.99|-2.86||Pre-specified sequential statistical testing procedure indicates that when p-value \<0.05, hierarchical testing continues.|Mixed model for repeated measurements|P-values are from an MMRM model with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.||All statistical tests were 2-sided with the estimated P-values at the 5% level of significance. To control for multiplicity, a pre-specified sequential testing procedure was applied to compare 10 mg and 5 mg vortioxetine to placebo; as soon as an endpoint was non-significant at 0.05, the testing procedure stopped for all subsequent endpoints.||-2.86|-6.99|<0.001
72605675|NCT00735709|144739588|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.12|||<|0.001|TWO_SIDED|95.0|-6.17|-2.08||Hierarchical testing stopped at SDS total score at Week 8 in the testing sequence, a nominal p-value is provided.|Mixed model for repeated measurements|P-values are from an MMRM model with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.||||-2.08|-6.17|<0.001
72605676|NCT00735709|144739588|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.52|||<|0.001|TWO_SIDED|95.0|-5.57|-1.47||This treatment arm is not in the testing sequence, a nominal p-value is provided.|Mixed model for repeated measurements|P-values are from an MMRM model with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.||||-1.47|-5.57|<0.001
72605677|NCT00735709|144739589|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.54||||0.135|TWO_SIDED|95.0|-3.56|0.48||Pre-specified sequential statistical testing procedure indicates that when p-value \>0.05, hierarchical testing stops and for subsequent endpoints in the sequence a nominal p-value is provided.|Mixed model repeated measurements|P-values are from an MMRM model with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.||||0.48|-3.56|0.135
72605678|NCT00735709|144739589|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.11||||0.263|TWO_SIDED|95.0|-3.07|0.84|||Mixed model repeated measurements|P-values are from an MMRM model with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.||||0.84|-3.07|0.263
72605679|NCT00735709|144739589|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.05||||0.963|TWO_SIDED|95.0|-2.03|1.94|||Mixed model repeated measurements|P-values are from an MMRM model with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.||||1.94|-2.03|0.963
72605680|NCT00735709|144739590|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.55|||<|0.001|TWO_SIDED|95.0|-0.8|-0.3|||Mixed model repeated measurements|P-values are from an MMRM model with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.||||-0.30|-0.80|<0.001
72605681|NCT00735709|144739590|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.47|||<|0.001|TWO_SIDED|95.0|-0.71|-0.22|||Mixed model repeated measurements|P-values are from an MMRM model with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.||||-0.22|-0.71|<0.001
72605682|NCT00735709|144739590|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.47|||<|0.001|TWO_SIDED|95.0|-0.72|-0.23|||Mixed model repeated measurements|P-values are from an MMRM model with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.||||-0.23|-0.72|<0.001
72605683|NCT00735709|144739591|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.348|||<|0.001|TWO_SIDED|95.0|1.995|5.618|||Regression, Logistic|Regression with explanatory variables for treatment and Baseline HAM-D24 score.|Odds ratio versus placebo.|||5.618|1.995|<0.001
72605684|NCT00735709|144739591|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.739|||<|0.001|TWO_SIDED|95.0|1.631|4.598|||Regression, Logistic|Regression with explanatory variables for treatment and Baseline HAM-D24 score.|Odds ratio versus placebo|||4.598|1.631|<0.001
72605685|NCT00735709|144739591|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.018|||<|0.001|TWO_SIDED|95.0|1.799|5.063|||Regression, Logistic|Regression with explanatory variables for treatment and Baseline HAM-D24 score.|Odds ratio versus placebo|||5.063|1.799|<0.001
72605686|NCT00735709|144739592|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.59||||0.001|TWO_SIDED|95.0|-7.34|-1.84|||Mixed model for repeated measurements|P-values are from an MMRM model with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.||||-1.84|-7.34|0.001
72605687|NCT00735709|144739592|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.47||||0.002|TWO_SIDED|95.0|-7.32|-1.62|||Mixed model for repeated measurements|P-values are from an MMRM model with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.||||-1.62|-7.32|0.002
72605688|NCT00735709|144739592|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.13||||0.004|TWO_SIDED|95.0|-6.9|-1.37|||Mixed model for repeated measurements|P-values are from an MMRM model with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.||||-1.37|-6.90|0.004
72605689|NCT00735709|144739593|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.951||||0.026|TWO_SIDED|95.0|1.082|3.517|||Regression, Logistic|Logistic regression with explanatory variables for treatment and Baseline MADRS score.||||3.517|1.082|0.026
72605690|NCT00735709|144739593|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.056||||0.015|TWO_SIDED|95.0|1.15|3.673|||Regression, Logistic|Logistic regression with explanatory variables for treatment and Baseline MADRS score.||||3.673|1.150|0.015
72605691|NCT00735709|144739593|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.753||||0.062|TWO_SIDED|95.0|0.973|3.158|||Regression, Logistic|Logistic regression with explanatory variables for treatment and Baseline MADRS score.||||3.158|0.973|0.062
72605692|NCT02492802|144739614|OTHER|||||||0.77|||||||The Wald Type III test|||||||0.77
72605693|NCT01165307|144739615|SUPERIORITY_OR_OTHER|||||||0.003|||||||Wilcoxon (Mann-Whitney)|||||||0.003
72605694|NCT01165307|144739616|SUPERIORITY_OR_OTHER|||||||0.82|||||||t-test, 2 sided|||Comparison between the groups for the SF-12 Physical Scale.||||0.82
72605695|NCT01165307|144739616|SUPERIORITY_OR_OTHER|||||||0.11|||||||t-test, 2 sided|||Comparison between the groups for the SF-12 mental scale.||||0.11
72605696|NCT01165307|144739617|SUPERIORITY_OR_OTHER|||||||0.12|||||||Wilcoxon (Mann-Whitney)|||||||0.12
72605697|NCT01165307|144739618|SUPERIORITY_OR_OTHER|||||||0.38|||||||Wilcoxon (Mann-Whitney)|||||||0.38
72605698|NCT01165307|144739619|SUPERIORITY_OR_OTHER|||||||0.12|||||||Wilcoxon (Mann-Whitney)|||||||0.12
72605699|NCT01165307|144739620|SUPERIORITY_OR_OTHER|||||||0.6|||||||Wilcoxon (Mann-Whitney)|||||||0.60
72605700|NCT01165307|144739621|SUPERIORITY_OR_OTHER|||||||0.42|||||||Wilcoxon (Mann-Whitney)|||||||0.42
72605701|NCT01165307|144739625|SUPERIORITY_OR_OTHER|||||||0.08|||||||Wilcoxon (Mann-Whitney)|||||||0.08
72605702|NCT03150082|144739655|EQUIVALENCE|Bio-equivalence analysis comparing ciprofloxacin test and reference product has been presented.|Percent ratio|96.88|||||TWO_SIDED|90.0|91.13|103.0|||||Percent ratio (GR37547 500 mg/ciprofloxacin 500 mg reference) has been presented.|||103.00|91.13|
72605703|NCT03150082|144739656|EQUIVALENCE|Bio-equivalence analysis comparing ciprofloxacin test and reference product has been presented.|Percent ratio|93.16|||||TWO_SIDED|90.0|86.09|100.82|||||Percent ratio (GR37547 500 mg/ciprofloxacin 500 mg reference) has been presented.|||100.82|86.09|
72605704|NCT03150082|144739657|EQUIVALENCE|Bio-equivalence analysis comparing ciprofloxacin test and reference product has been presented.|Percent ratio|96.96|||||TWO_SIDED|90.0|91.17|103.11|||||Percent ratio (GR37547 500 mg/ciprofloxacin 500 mg reference) has been presented.|||103.11|91.17|
72416282|NCT01972841|144343314|SUPERIORITY||Least squares mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.13||0.993|TWO_SIDED|95.0|-0.25|0.25|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (solifenacin 5 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||0.25|-0.25|0.993
72605705|NCT03150082|144739658|EQUIVALENCE|Bio-equivalence analysis comparing ciprofloxacin test and reference product has been presented.||||||0.3499||||||"P value was analyzed using a nonparametric Wilcoxon signed-rank test."|Wilcoxon signed-rank test|||||||0.3499
72605706|NCT00458003|144739690|SUPERIORITY|||||||0.38|||||||Wilcoxon (Mann-Whitney)|||||||.38
72605707|NCT00458003|144739691|SUPERIORITY|||||||0.1|||||||Wilcoxon (Mann-Whitney)|||||||.10
72605708|NCT00809445|144739692|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|4.52|||<|0.001|TWO_SIDED|97.5|3.57|5.72||a-prior threshold for statistical significance is .025|Cochran-Mantel-Haenszel||The numerator is the two HIV rapid testing arms The denominator is the HIV testing referral arm|Hypothesis: The HIV rapid testing arms would have a higher rate of HIV testing than the HIV testing referral arm. Thus there is one comparison: HIV rapid test \& counseling+HIV rapid test and info versus HIV testing referral.||5.72|3.57|<0.001
72605709|NCT00809445|144739693|SUPERIORITY_OR_OTHER||incidence rate raios (IRR)|1.04||||0.39|TWO_SIDED|97.5|0.95|1.14||a-priori threshold for statistical significance is .025|generalized estimating equations (GEE)||Numerator includes the two HIV rapid testing groups Denominator is the HIV testing referral group|Hypothesis: The HIV rapid testing arms would have a lower rate of unprotected sexual episodes than the HIV testing referral arm. Thus there is one comparison: HIV rapid test \& counseling+HIV rapid test and info versus HIV testing referral.||1.14|0.95|0.39
72605710|NCT00809445|144739693|SUPERIORITY_OR_OTHER||Incidence rate ratio (IRR)|1.03||||0.81|TWO_SIDED|97.5|0.84|1.26||a-priori threshold for statistical significance is .025|Generalized estimating equations (GEE)||Numerator is the HIV rapid test and counseling arm Denominator is the HIV rapid test and info arm|"The data analysis information presented is for the comparison of the 2 on-site testing groups.~Hypothesis: HIV rapid test and counseling group will have fewer unprotected sexual acts than will HIV rapid test and info group"||1.26|0.84|0.81
72605711|NCT00809445|144739694|SUPERIORITY_OR_OTHER|||||||0.044||||||a priori threshold for significance was .05|Chi-squared|Note that this is a 3 by 3 chi-square: the 3 conditions by discontinued sharing needles /no change in sharing needles/initiated sharing needles||||||0.044
72605712|NCT00809445|144739695|SUPERIORITY_OR_OTHER||||||<|0.0001||||||a-priori threshold for statistical significance is .05|Chi-squared|chi-square = 428.2466, Df=2||||||<0.0001
72416283|NCT01972841|144343314|SUPERIORITY||Least squares mean difference|-0.06|STANDARD_ERROR_OF_MEAN|0.13||0.65|TWO_SIDED|95.0|-0.3|0.19|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (solifenacin 5 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||0.19|-0.30|0.650
72416284|NCT01972841|144343314|SUPERIORITY||Least squares mean difference|-0.27|STANDARD_ERROR_OF_MEAN|0.13||0.035|TWO_SIDED|95.0|-0.52|-0.02|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (mirabegron 25 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||-0.02|-0.52|0.035
72605713|NCT01272908|144739709|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.293||||0.253|||||||Regression, Logistic|||ACR20: Week 12 versus (vs) Week 4||||0.253
72605714|NCT01272908|144739709|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.019||||0.005|||||||Regression, Logistic|||ACR20: Week 24 vs Week 4||||0.005
72605715|NCT01272908|144739709|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.552||||0.023|||||||Regression, Logistic|||ACR50: Week 12 vs Week 4||||0.023
72605716|NCT01272908|144739709|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.861||||0.001|||||||Regression, Logistic|||ACR50: Week 24 vs. Week 4||||0.001
72605717|NCT01272908|144739713|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.099||||0.667|||||||Regression, Logistic|||Good vs Moderate vs None: Week 12 vs Week 4||||0.667
72605718|NCT01272908|144739713|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.589|||<|0.001|||||||Regression, Logistic|||Good vs Moderate vs None: Week 24 vs Week 4||||<0.001
72605719|NCT01272908|144739713|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.138||||0.44|||||||Regression, Logistic|||Good/Moderate vs None: Week 12 vs Week 4||||0.440
72416285|NCT01972841|144343314|SUPERIORITY||Least squares mean difference|-0.18|STANDARD_ERROR_OF_MEAN|0.13||0.169|TWO_SIDED|95.0|-0.43|0.08|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (mirabegron 50 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate||0.08|-0.43|0.169
72416286|NCT01972841|144343315|SUPERIORITY||Odds Ratio (OR)|1.37||||0.003|TWO_SIDED|95.0|1.11|1.68|||Overdispersed binomial regression|||Odds ratio from a overdispersed binomial regression model (Williams' method) including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline logarithm of mean number of incontinence episodes per 24 hours as a covariate.||1.68|1.11|0.003
72605720|NCT01272908|144739713|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.009||||0.012|||||||Regression, Logistic|||Good/Moderate vs None: Week 24 vs Week 4||||0.012
72605721|NCT01272908|144739715|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 1 sided|||Week 4||||<0.001
72605722|NCT01272908|144739715|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 1 sided|||Week 12||||<0.001
72605723|NCT01272908|144739715|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 1 sided|||Week 24||||<0.001
72605724|NCT01272908|144739715|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 1 sided|||Week 36||||<0.001
72605725|NCT01272908|144739715|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 1 sided|||Week 48||||<0.001
72605726|NCT01272908|144739717|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon Signed-Rank test|||Baseline vs Week 24||||<0.001
72605727|NCT01272908|144739719|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 1 sided|||Baseline vs Week 24||||<0.001
72605728|NCT01272908|144739721|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 1 sided|||Baseline vs Week 24||||<0.001
72605729|NCT01272908|144739723|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon Signed Rank test|||Baseline vs Week 24||||<0.001
72605730|NCT01272908|144739725|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 1 sided|||Baseline vs Week 24||||<0.001
72605731|NCT01272908|144739727|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon Signed Rank test|||Baseline vs Week 24||||<0.001
72416287|NCT01972841|144343315|SUPERIORITY||Odds Ratio (OR)|1.36||||0.004|TWO_SIDED|95.0|1.11|1.68|||Overdispersed binomial regression|||Odds ratio from a overdispersed binomial regression model (Williams' method) including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline logarithm of mean number of incontinence episodes per 24 hours as a covariate.||1.68|1.11|0.004
72416288|NCT01972841|144343315|SUPERIORITY||Odds Ratio (OR)|1.59|||<|0.001|TWO_SIDED|95.0|1.29|1.95|||Overdispersed binomial regression|||Odds ratio from a overdispersed binomial regression model (Williams' method) including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline logarithm of mean number of incontinence episodes per 24 hours as a covariate.||1.95|1.29|<0.001
72416289|NCT01972841|144343315|SUPERIORITY||Odds Ratio (OR)|1.36||||0.004|TWO_SIDED|95.0|1.1|1.68|||Overdispersed binomial regression|||Odds ratio from a overdispersed binomial regression model (Williams' method) including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline logarithm of mean number of incontinence episodes per 24 hours as a covariate.||1.68|1.10|0.004
72416290|NCT01972841|144343316|SUPERIORITY||Odds Ratio (OR)|1.23||||0.039|TWO_SIDED|95.0|1.01|1.5|||Overdispersed binomial regression|||Odds ratio from a overdispersed binomial regression model (Williams' method) including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline mean number of micturitions per 24 hours as a covariate.||1.50|1.01|0.039
72605732|NCT01272908|144739729|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon Signed Rank test|||Baseline vs Week 24||||<0.001
72605733|NCT01272908|144739731|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon Signed Rank test|||Baseline vs Week 24||||<0.001
72605734|NCT01272908|144739735|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 1 sided|||Baseline vs Week 12||||<0.001
72605735|NCT01272908|144739735|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon Signed Rank test|||Baseline vs Week 24||||<0.001
72605736|NCT03143101|144739750|SUPERIORITY||Mean Difference (Net)|18.1||||0.006|TWO_SIDED|95.0|4.8|30.9||p-value is calculated from the Cochran-Mantel-Haenszel (CMH) test adjusting for the prior influenza vaccination status.|Cochran-Mantel-Haenszel|||||30.9|4.8|0.006
72605737|NCT03143101|144739754|SUPERIORITY||Mean Difference (Net)|32.7|||<|0.001|TWO_SIDED|95.0|14.4|47.8||p-value is calculated from the CMH test adjusting for the prior influenza vaccination status.|Cochran-Mantel-Haenszel|||||47.8|14.4|<0.001
72605738|NCT01630135|144739767|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-1.089|||<|0.001|TWO_SIDED|95.0|-1.41|-0.76|||ANCOVA||The analysis was based on an analysis of covariance (ANCOVA) with a model adjusting for Treatment, Baseline, Age, and Sex.|||-0.76|-1.41|<0.001
72605739|NCT02554760|144739783|OTHER||success proportion|84.2|||||TWO_SIDED|95.0|60.4|92.3|||Catagorical tabulation|||||92.3|60.4|
72605740|NCT02554760|144739783|OTHER||success proportion|78.9|||||TWO_SIDED|95.0|54.4|93.9||||||||93.9|54.4|
72605741|NCT03243305|144739810|OTHER||Seven-cycle Pregnancy Percentage|13.65|||||TWO_SIDED|95.0|9.91|17.39|||Kaplan-Meier|||The primary hypothesis to be tested is whether subjects using Amphora vaginal gel have a 7-cycle cumulative pregnancy percentage less than or equal to 21%||17.39|9.91|
72605742|NCT02689804|144739812|SUPERIORITY||||||<|0.01|||||||t-test, 2 sided|||||||<0.01
72605743|NCT02689804|144739813|SUPERIORITY|||||||0.15|||||||t-test, 2 sided|||||||0.15
72605744|NCT01569126|144739836|SUPERIORITY_OR_OTHER||Slope|0.026||||||95.0|||||||The correlation of time-matched change from baseline QTcF interval (dependent variable) to the time-matched plasma concentration of total fluoxetine and norfluoxetine (covariate) and participant (random effect).|||||
72605745|NCT01585246|144739842|OTHER||Maximum Tolerated Dose (MTD)|960.0|||||TWO_SIDED|||||||||The time-to-event continual reassessment method (TITE-CRM) was used The TITE-CRM incorporated a decision rule for the allocation of next participant to a dose of SP based on the current estimate of toxicity. The first men were allocated to lowest dose (320 mg); when no adverse event was reported during 12 weeks, the dose was increased to 640 mg for next men, and then to 960 mg in the absence of advert event.||||
72605746|NCT03113968|144739871|NON_INFERIORITY|The Farrington-Manning score test was used to assess the noninferiority of KET.|||||<|0.001|||||||The Farrington-Manning score test|||||||<.001
72605747|NCT03113968|144739872|SUPERIORITY||Mean Difference (Net)|9.3|||||TWO_SIDED||||||||||P-values not reported|||
72605748|NCT01387178|144739873|SUPERIORITY_OR_OTHER||Adjusted Mean|7451.0|||||TWO_SIDED|95.0|5857.0|9045.0|||||The mean predicted cost for inpatient services for participants treated with FSC. A generalized linear model with a log link function and gamma distribution for the error term to resolve the issue of skewed cost distribution was used.|||9045|5857|
72605749|NCT01387178|144739873|SUPERIORITY_OR_OTHER||Adjusted Mean|11545.0|||||TWO_SIDED|95.0|8827.0|14263.0|||||The mean predicted cost for inpatient services for participants treated with TIO. A generalized linear model with a log link function and gamma distribution for the error term to resolve the issue of skewed cost distribution was used.|||14263|8827|
72605750|NCT01387178|144739873|SUPERIORITY_OR_OTHER||Adjusted Mean|61.0|||||TWO_SIDED|95.0|58.0|63.0|||||The mean predicted cost for emergency department visits for participants treated with FSC. A generalized linear model with a log link function and gamma distribution for the error term to resolve the issue of skewed cost distribution was used.|||63|58|
72605751|NCT01387178|144739873|SUPERIORITY_OR_OTHER||Adjusted Mean|51.0|||||TWO_SIDED|95.0|49.0|53.0|||||The mean predicted cost for emergency department visits for participants treated with TIO. A generalized linear model with a log link function and gamma distribution for the error term to resolve the issue of skewed cost distribution was used.|||53|49|
72605752|NCT01387178|144739873|SUPERIORITY_OR_OTHER||Adjusted Mean|231.0|||||TWO_SIDED|95.0|227.0|234.0|||||The mean predicted cost for office visits for participants treated with FSC. A generalized linear model with a log link function and gamma distribution for the error term to resolve the issue of skewed cost distribution was used.|||234|227|
72605753|NCT01387178|144739873|SUPERIORITY_OR_OTHER||Adjusted Mean|295.0|||||TWO_SIDED|95.0|290.0|299.0|||||The mean predicted cost for office visits for participants treated with TIO. A generalized linear model with a log link function and gamma distribution for the error term to resolve the issue of skewed cost distribution was used.|||299|290|
72605754|NCT01387178|144739873|SUPERIORITY_OR_OTHER||Adjusted Mean|873.0|||||TWO_SIDED|95.0|827.0|919.0|||||The mean predicted cost for other outpatient and ancillary services for FSC participants. A generalized linear model with a log link function and gamma distribution for the error term to resolve the issue of skewed cost distribution was used.|||919|827|
72605755|NCT01387178|144739873|SUPERIORITY_OR_OTHER||Adjusted Mean|1080.0|||||TWO_SIDED|95.0|1022.0|1138.0|||||The mean predicted cost for other outpatient and ancillary services for TIO participants. A generalized linear model with a log link function and gamma distribution for the error term to resolve the issue of skewed cost distribution was used.|||1138|1022|
72605756|NCT01387178|144739873|SUPERIORITY_OR_OTHER||Adjusted Mean|1267.0|||||TWO_SIDED|95.0|1251.0|1283.0|||||The mean predicted cost for pharmacy services for participants treated with FSC. A generalized linear model with a log link function and gamma distribution for the error term to resolve the issue of skewed cost distribution was used.|||1283|1251|
72605757|NCT01387178|144739873|SUPERIORITY_OR_OTHER||Adjusted Mean|1250.0|||||TWO_SIDED|95.0|1234.0|1266.0|||||The mean predicted cost for pharmacy services for participants treated with TIO. A generalized linear model with a log link function and gamma distribution for the error term to resolve the issue of skewed cost distribution was used.|||1266|1234|
72605758|NCT01387178|144739873|SUPERIORITY_OR_OTHER||Adjusted Mean|1175.0|||||TWO_SIDED|95.0|1083.0|1267.0|||||The mean predicted cost for inpatient and emergency department services for FSC participants. A generalized linear model with a log link function and gamma distribution for the error term to resolve the issue of skewed cost distribution was used.|||1267|1083|
72605759|NCT01387178|144739873|SUPERIORITY_OR_OTHER||Adjusted Mean|1566.0|||||TWO_SIDED|95.0|1438.0|1695.0|||||The mean predicted cost for inpatient and emergency department services for TIO participants. A generalized linear model with a log link function and gamma distribution for the error term to resolve the issue of skewed cost distribution was used.|||1695|1438|
72605760|NCT01387178|144739873|SUPERIORITY_OR_OTHER||Adjusted Mean|2991.0|||||TWO_SIDED|95.0|2922.0|3059.0|||||The mean predicted cost for total healthcare services for participants treated with FSC. A generalized linear model with a log link function and gamma distribution for the error term to resolve the issue of skewed cost distribution was used.|||3059|2922|
72605761|NCT01387178|144739873|SUPERIORITY_OR_OTHER||Adjusted Mean|3304.0|||||TWO_SIDED|95.0|3221.0|3386.0|||||The mean predicted cost for total healthcare services for participants treated with TIO. A generalized linear model with a log link function and gamma distribution for the error term to resolve the issue of skewed cost distribution was used.|||3386|3221|
72605762|NCT01387178|144739874|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.964||||0.2198||95.0|0.909|1.022||Risk of Moderate COPD Exacerbations|Regression, Cox|||||1.022|0.909|0.2198
72605763|NCT01387178|144739874|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.864||||0.0406||95.0|0.752|0.994||Risk of Severe COPD Exacerbations|Regression, Cox|||||0.994|0.752|0.0406
72605764|NCT01387178|144739874|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.953||||0.0962||95.0|0.901|1.009||Risk of Any COPD Exacerbation|Regression, Cox|||||1.009|0.901|0.0962
72605765|NCT04805671|144739876|SUPERIORITY||Risk Difference (RD)|-8.7||||0.0047|TWO_SIDED|95.0|-14.71|-2.67|||Regression, Logistic|||ADG20 vs Placebo|A statistical method described in Ge et al. (2011) was used to compute a population-level estimate for the treatment difference (in terms of difference in proportion) with adjustment for the pre-defined prognostic factors. The variance of the estimated treatment difference or relative risk reduction was estimated using the delta method.|-2.67|-14.71|0.0047
72605766|NCT04805671|144739881|SUPERIORITY||Risk Difference (RD)|-11.3||||0.0007|TWO_SIDED|95.0|-17.86|-4.81|||Regression, Logistic|||ADG20 vs Placebo|A statistical method described in Ge et al. (2011) was used to compute a population-level estimate for the treatment difference (in terms of difference in proportion) with adjustment for the pre-defined prognostic factors. The variance of the estimated treatment difference or relative risk reduction was estimated using the delta method.|-4.81|-17.86|0.0007
72605767|NCT04805671|144739882|SUPERIORITY||Risk Difference (RD)|-8.7||||0.0047|TWO_SIDED|95.0|-14.71|-2.67|||Regression, Logistic|||ADG20 vs Placebo|A statistical method described in Ge et al. (2011) was used to compute a population-level estimate for the treatment difference (in terms of difference in proportion) with adjustment for the pre-defined prognostic factors. The variance of the estimated treatment difference or relative risk reduction was estimated using the delta method.|-2.67|-14.71|0.0047
72605768|NCT04805671|144739883|SUPERIORITY||Risk Difference (RD)|-11.3||||0.0007|TWO_SIDED|95.0|-17.86|-4.81|||Regression, Logistic|||ADG20 vs Placebo|A statistical method described in Ge et al. (2011) was used to compute a population-level estimate for the treatment difference (in terms of difference in proportion) with adjustment for the pre-defined prognostic factors. The variance of the estimated treatment difference or relative risk reduction was estimated using the delta method.|-4.81|-17.86|0.0007
72605769|NCT04805671|144739884|SUPERIORITY||Hazard Ratio (HR)|1.237||||0.0938|TWO_SIDED|95.0|0.964|1.586|||Regression, Cox|||ADG20 vs. Placebo||1.586|0.964|0.0938
72605770|NCT04805671|144739885|SUPERIORITY||Hazard Ratio (HR)|0.137||||0.0361|TWO_SIDED|95.0|0.016|1.162|||Regression, Cox|||ADG20 vs Placebo||1.162|0.016|0.0361
72605771|NCT04805671|144739886|SUPERIORITY||Hazard Ratio (HR)|1.255||||0.0781|TWO_SIDED|95.0|0.974|1.617|||Regression, Cox|||ADG20 vs Placebo||1.617|0.974|0.0781
72605772|NCT04805671|144739887|SUPERIORITY||Mean Difference (Final Values)|-0.17||||0.4976|TWO_SIDED|95.0|-0.66|0.32|||ANCOVA|||ADG20 vs. Placebo||0.32|-0.66|0.4976
72605773|NCT04805671|144739888|SUPERIORITY||Hazard Ratio (HR)|1.048||||0.7239|TWO_SIDED|95.0|0.806|1.364|||Regression, Cox|||||1.364|0.806|0.7239
72605774|NCT04805671|144739889|SUPERIORITY||Risk Difference (RD)|-11.1||||0.0364|TWO_SIDED|95.0|-21.42|-0.7|||Regression, Logistic|||||-0.70|-21.42|0.0364
72416291|NCT01972841|144343316|SUPERIORITY||Odds Ratio (OR)|1.3||||0.009|TWO_SIDED|95.0|1.07|1.59|||Overdispersed binomial regression|||Odds ratio from a overdispersed binomial regression model (Williams' method) including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline mean number of micturitions per 24 hours as a covariate.||1.59|1.07|0.009
72605775|NCT04805671|144739890|SUPERIORITY||Risk Difference (RD)|8.2||||0.0227|TWO_SIDED|95.0|1.15|15.31||The p-value and risk difference reported was calculated based on the Day 5 timepoint.|Regression, Logistic|||||15.31|1.15|0.0227
72605776|NCT04805671|144739891|SUPERIORITY||Mean Difference (Final Values)|-6.93||||0.1124|TWO_SIDED|95.0|-15.49|1.64|||ANCOVA|||||1.64|-15.49|0.1124
72605777|NCT01246895|144739922|SUPERIORITY_OR_OTHER|||||||0.017|TWO_SIDED|||||P-values were obtained using general estimating equations (GEE) for longitudinal analysis of repeated correlated measures.|general estimating equations (GEE)|P-values were obtained using general estimating equations (GEE) for longitudinal analysis of repeated correlated measures.||||||0.017
72605778|NCT01246895|144739923|SUPERIORITY_OR_OTHER|||||||0.026|TWO_SIDED|||||P-values were obtained using general estimating equations (GEE) for longitudinal analysis of repeated correlated measures.|general estimating equations (GEE)|P-values were obtained using general estimating equations (GEE) for longitudinal analysis of repeated correlated measures.||||||0.026
72605779|NCT01246895|144739924|SUPERIORITY_OR_OTHER|||||||0.474|TWO_SIDED|||||P-values were obtained using general estimating equations (GEE) for longitudinal analysis of repeated correlated measures.|general estimating equations (GEE)|P-values were obtained using general estimating equations (GEE) for longitudinal analysis of repeated correlated measures.||WOMAC subscale - Pain||||0.474
72416292|NCT01972841|144343316|SUPERIORITY||Odds Ratio (OR)|1.45|||<|0.001|TWO_SIDED|95.0|1.19|1.77|||overdispersed binomial regression|||Odds ratio from a overdispersed binomial regression model (Williams' method) including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline mean number of micturitions per 24 hours as a covariate.||1.77|1.19|<0.001
72605780|NCT01246895|144739924|SUPERIORITY_OR_OTHER|||||||0.236|TWO_SIDED|||||P-values were obtained using general estimating equations (GEE) for longitudinal analysis of repeated correlated measures.|general estimating equations (GEE)|P-values were obtained using general estimating equations (GEE) for longitudinal analysis of repeated correlated measures.||WOMAC subscale - Stiffness||||0.236
72605781|NCT01246895|144739924|SUPERIORITY_OR_OTHER|||||||0.326|TWO_SIDED|||||P-values were obtained using general estimating equations (GEE) for longitudinal analysis of repeated correlated measures.|general estimating equations (GEE)|P-values were obtained using general estimating equations (GEE) for longitudinal analysis of repeated correlated measures.||WOMAC subscale - Physical function||||0.326
72605782|NCT01246895|144739925|SUPERIORITY_OR_OTHER|||||||0.01|||||||Physical count|||||||0.01
72605783|NCT01246895|144739926|SUPERIORITY_OR_OTHER|||||||0.478|TWO_SIDED|||||P-values were obtained using general estimating equations (GEE) for longitudinal analysis of repeated correlated measures.|general estimating equations (GEE)|P-values were obtained using general estimating equations (GEE) for longitudinal analysis of repeated correlated measures.||SF-36 v2 Physical component||||0.478
72605784|NCT01246895|144739926|SUPERIORITY_OR_OTHER|||||||0.125|TWO_SIDED|||||P-values were obtained using general estimating equations (GEE) for longitudinal analysis of repeated correlated measures.|general estimating equations (GEE)|P-values were obtained using general estimating equations (GEE) for longitudinal analysis of repeated correlated measures.||SF-36 v2 Mental component||||0.125
72605785|NCT01871077|144739938|OTHER|||||||0.89|||||||Friedman test|||||||0.890
72605786|NCT01871077|144739939|OTHER|||||||0.078|||||||Wilcoxon (Mann-Whitney)|||||||0.078
72605787|NCT01871077|144739940|OTHER|||||||1|||||||Friedman test|||||||1.000
72416293|NCT01972841|144343316|SUPERIORITY||Odds Ratio (OR)|1.5|||<|0.001|TWO_SIDED|95.0|1.23|1.84|||Overdispersed binomial regression|||Odds ratio from a overdispersed binomial regression model (Williams' method) including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline mean number of micturitions per 24 hours as a covariate||1.84|1.23|<0.001
72605788|NCT01871077|144739941|OTHER|||||||0.497|||||||Wilcoxon (Mann-Whitney)|||||||.497
72416294|NCT01972841|144343317|SUPERIORITY||Odds Ratio (OR)|1.32||||0.011|TWO_SIDED|95.0|1.07|1.64|||Overdispersed binomial regression|||Odds ratio from a overdispersed binomial regression model (Williams' method) including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline mean number of micturitions per 24 hours as a covariate.||1.64|1.07|0.011
72605789|NCT04878120|144739942|SUPERIORITY|||||||0.733||||||For interaction between study group and intervention|ANOVA|||"The study followed a randomized crossover design, with two study groups and two intervention types; the two groups differed in the order they received the two intervention types. To test the hypothesis that HCL Control with Smart Bolus Calculator reduces exposure to hypoglycemia with respect to Standard HCL Control, a mixed ANOVA was performed with LBGI as outcome measure, study group as between-subject factor, and intervention type as within-subject factor."||||0.733
72605790|NCT04878120|144739943|SUPERIORITY|||||||0.824||||||For interaction between study group and intervention|ANOVA|||The study followed a randomized crossover design, with two study groups and two intervention types; the two groups differed in the order they received the two intervention types. A mixed ANOVA was performed with percentage of time spent below 70 mg/dL as outcome measure, study group as between-subject factor, and intervention type as within-subject factor.||||0.824
72605791|NCT04878120|144739944|SUPERIORITY|||||||0.402||||||For interaction between study group and intervention|ANOVA|||The study followed a randomized crossover design, with two study groups and two intervention types; the two groups differed in the order they received the two intervention types. A mixed ANOVA was performed with percentage of time spent in 70-180 mg/dL as outcome measure, study group as between-subject factor, and intervention type as within-subject factor.||||0.402
72605792|NCT04878120|144739945|SUPERIORITY|||||||0.3||||||For interaction between study group and intervention|ANOVA|||The study followed a randomized crossover design, with two study groups and two intervention types; the two groups differed in the order they received the two intervention types. A mixed ANOVA was performed with percentage of time spent above 180 mg/dL as outcome measure, study group as between-subject factor, and intervention type as within-subject factor.||||0.300
72605793|NCT04878120|144739946|SUPERIORITY|||||||0.168||||||For interaction between study arm and intervention|ANOVA|||The study followed a randomized crossover design, with two study groups and two intervention types; the two groups differed in the order they received the two intervention types. A mixed ANOVA was performed with HBGI as outcome measure, study group as between-subject factor, and intervention type as within-subject factor.||||0.168
72416295|NCT01972841|144343317|SUPERIORITY||Odds Ratio (OR)|1.41||||0.002|TWO_SIDED|95.0|1.14|1.75|||Overdispersed binomial regression|||Odds ratio from a overdispersed binomial regression model (Williams' method) including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline mean number of micturitions per 24 hours as a covariate.||1.75|1.14|0.002
72416296|NCT01972841|144343317|SUPERIORITY||Odds Ratio (OR)|1.65|||<|0.001|TWO_SIDED|95.0|1.32|2.06|||Overdispersed binomial regression|||Odds ratio from a overdispersed binomial regression model (Williams' method) including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline mean number of micturitions per 24 hours as a covariate.||2.06|1.32|<0.001
72605794|NCT04878120|144739947|SUPERIORITY|||||||0.476||||||For interaction between study group and intervention|ANOVA|||The study followed a randomized crossover design, with two study groups and two intervention types; the two groups differed in the order they received the two intervention types. A mixed ANOVA was performed with CGM coefficient of variation as outcome measure, study group as between-subject factor, and intervention type as within-subject factor.||||0.476
72605795|NCT04878120|144739948|SUPERIORITY|||||||0.914||||||For interaction between study group and intervention|ANOVA|||The study followed a randomized crossover design, with two study groups and two intervention types; the two groups differed in the order they received the two intervention types. A mixed ANOVA was performed with total amount of carbohydrate administered as rescue treatments as outcome measure, study group as between-subject factor, and intervention type as within-subject factor.||||0.914
72605796|NCT01691378|144739962|SUPERIORITY||Mean Difference (Final Values)|4.4||||0.03|TWO_SIDED|95.0|0.52|8.3|||ANCOVA|||"Analyses 2-sided test w/ sig level .05. N=35 analyzed w/ α .05 provided 80% power to detect effect size d=1. T1 variables compared using Wilcoxon rank sum \& Fisher exact tests. Per protocol analysis, all participants required T2 BHS.~T2 BHS compared bet arms controlling for T1 BHS. No confounders significant at .10, not included in model. Analysis of covariance modeled T2 BHS as function of arm \& T1 BHS. Estimated mean difference in T2 scores calculated, no adjustment for multiple comparisons."||8.3|.52|.03
72605797|NCT01691378|144739962|SUPERIORITY||Mean Difference (Final Values)|-4.6||||0.01|TWO_SIDED|95.0|-7.9|-1.3|||Regression, Linear|||"Analysis contrasted T1 to T2 change with T2 to T3 change in Waitlist arm only. Waitlist participants serve as their own control \& only variable controlled for was change in Waitlist period (if participants improved greatly during Waitlist period, they would no longer have enough room to change in Intervention period). Linear regression used with difference in change as dependent variable \& Waitlist period change as only predictor. Estimated mean difference in change calculated from this model."||-1.3|-7.9|.01
72605798|NCT01691378|144739962|SUPERIORITY||Mean Difference (Final Values)|-6.3||||0.0007|TWO_SIDED|95.0|-9.3|-3.2|||one-sample t-test|||Analysis investigated change from T1 to T3 within the WtoH Intervention first arm only. This difference was calculated and a 1-sample t test was used to determine whether the estimate was different from zero. As this change was not compared with a control group change, baseline values were not accounted for.||-3.2|-9.3|.0007
72605799|NCT01691378|144739963|SUPERIORITY||Mean Difference (Final Values)|3.8||||0.07|TWO_SIDED|95.0|-0.29|8.0|||ANCOVA|||"Analyses 2-sided test w/ sig level .05. N=35 analyzed w/ α .05 provided 80% power to detect effect size d=1. T1 variables compared using Wilcoxon rank sum \& Fisher exact tests. Per protocol analysis, all participants required T2 BHS.~T2 BSS compared bet arms controlling for T1 BSS. No confounders significant at .10, not included in model. Analysis of covariance modeled T2 BSS as function of arm \& T1 BSS. Estimated mean difference in T2 scores calculated, no adjustment for multiple comparisons."||8.0|-.29|.07
72605800|NCT01691378|144739963|SUPERIORITY||Mean Difference (Final Values)|-0.01||||0.94|TWO_SIDED|95.0|-3.3|3.1|||Regression, Linear|||"Analysis contrasted T1 to T2 change with T2 to T3 change in Waitlist arm only. Waitlist participants serve as their own control \& only variable controlled for was change in Waitlist period (if participants improved greatly during Waitlist period, they would no longer have enough room to change in Intervention period). Linear regression used with difference in change as dependent variable \& Waitlist period change as only predictor. Estimated mean difference in change calculated from this model."||3.1|-3.3|.94
72605801|NCT01691378|144739963|SUPERIORITY||Mean Difference (Final Values)|-3.5||||0.06|TWO_SIDED|95.0|-7.0|0.12|||one-sample t-test|||Analysis investigated change from T1 to T3 within the WtoH Intervention first arm only. This difference was calculated and a 1-sample t test was used to determine whether the estimate was different from zero. As this change was not compared with a control group change, baseline values were not accounted for.||.12|-7.0|.06
72605802|NCT01691378|144739964|SUPERIORITY||Mean Difference (Final Values)|5.6||||0.13|TWO_SIDED|95.0|-1.7|12.9|||ANCOVA|||"Analyses 2-sided test w/ sig level .05. N=35 analyzed w/ α .05 provided 80% power to detect effect size d=1. T1 variables compared using Wilcoxon rank sum \& Fisher exact tests. Per protocol analysis, all participants required T2 BHS.~T2 BDI compared bet arms controlling for T1 BDI. No confounders significant at .10, not included in model. Analysis of covariance modeled T2 BDI as function of arm \& T1 BDI. Estimated mean difference in T2 scores calculated, no adjustment for multiple comparisons."||12.9|-1.7|.13
72605803|NCT01691378|144739964|SUPERIORITY||Mean Difference (Final Values)|-8.7||||0.003|TWO_SIDED|95.0|-13.8|-3.6|||Regression, Linear|||"Analysis contrasted T1 to T2 change with T2 to T3 change in Waitlist arm only. Waitlist participants serve as their own control \& only variable controlled for was change in Waitlist period (if participants improved greatly during Waitlist period, they would no longer have enough room to change in Intervention period). Linear regression used with difference in change as dependent variable \& Waitlist period change as only predictor. Estimated mean difference in change calculated from this model."||-3.6|-13.8|.003
72416297|NCT01972841|144343317|SUPERIORITY||Odds Ratio (OR)|1.66|||<|0.001|TWO_SIDED|95.0|1.33|2.07|||Overdispersed binomial regression|||Odds ratio from a overdispersed binomial regression model (Williams' method) including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline mean number of micturitions per 24 hours as a covariate.||2.07|1.33|<0.001
72605804|NCT01691378|144739964|SUPERIORITY||Mean Difference (Final Values)|-11.6||||0.002|TWO_SIDED|95.0|-18.0|-5.3|||one-sample t-test|||Analysis investigated change from T1 to T3 within the WtoH Intervention first arm only. This difference was calculated and a 1-sample t test was used to determine whether the estimate was different from zero. As this change was not compared with a control group change, baseline values were not accounted for.||-5.3|-18.0|.002
72605805|NCT02493517|144740069|NON_INFERIORITY|The non-inferiority margin is defined as 0.6 SDS for the upper limit of 95% CI of the LS mean difference of the log-transformed IGF-1 SDS without back-transformation.|Treatment difference|-0.32|||||TWO_SIDED|95.0|-0.74|0.11||||||"The Least Square (LS) Means and 95% Confidence Intervals (CIs) were based on the generalised linear model (GLM) with IGF-1 SDS change from baseline values as dependent variable, with treatment group and previous pituitary surgery as independent factors, and the baseline value of IGF-1 SDS as independent covariate. A log-transformation with base e was applied to the IGF-1 SDS data before analysing.~The treatment difference (lanreotide Autogel - lanreotide PR) is presented."||0.11|-0.74|
72605806|NCT02493517|144740069|NON_INFERIORITY|The non-inferiority margin for the back-transformed LS Mean ratio of IGF-1 SDS of lanreotide Autogel versus lanreotide PR is exp (0.6) = 1.822.|LS Mean ratio|0.73|||||TWO_SIDED|95.0|0.48|1.11||||||"The LS Means and 95% CIs were based on the GLM with IGF-1 SDS change from baseline values as dependent variable, with treatment group and previous pituitary surgery as independent factors, and the baseline value of IGF-1 SDS as independent covariate. A log-transformation with base e was applied to the IGF-1 SDS data before analysing.~The LS Mean ratio (lanreotide Autogel versus lanreotide PR) is presented."||1.11|0.48|
72605807|NCT02493517|144740070|OTHER||Risk Difference (RD)|6.3|||||TWO_SIDED|95.0|-5.2|17.7||||||The risk difference (lanreotide Autogel - lanreotide PR) in the percentage of normal IGF-1 SDS values at EOST/EW Visit is presented.||17.7|-5.2|
72605808|NCT02493517|144740071|OTHER||Risk Difference (RD)|-1.6|||||TWO_SIDED|95.0|-17.5|14.4||||||The risk difference (lanreotide Autogel - lanreotide PR) in the percentage of GH levels ≤2.5 mcg/L at EOST/EW Visit is presented.||14.4|-17.5|
72605809|NCT02493517|144740072|OTHER||Risk Difference (RD)|1.6|||||TWO_SIDED|95.0|-8.9|12.0||||||The risk difference (lanreotide Autogel - lanreotide PR) in the percentage of GH levels ≤1 mcg/L at EOST/EW Visit is presented.||12.0|-8.9|
72605810|NCT02493517|144740073|OTHER||Risk Difference (RD)|4.7|||||TWO_SIDED|95.0|-3.1|12.5||||||The risk difference (lanreotide Autogel - lanreotide PR) in the percentage subjects with normal IGF-1 levels and who have GH levels \>1 mcg/L and ≤2.5 mcg/L at EOST/EW Visit is presented.||12.5|-3.1|
72605811|NCT02493517|144740074|OTHER||Treatment difference|3.63|STANDARD_DEVIATION|21.6|||TWO_SIDED|95.0|-3.98|11.25||||||Treatment difference (lanreotide Autogel - lanreotide PR) is presented.||11.25|-3.98|
72605812|NCT02493517|144740075|OTHER||Risk Difference (RD)|-5.5|||||TWO_SIDED|95.0|-24.3|13.3||||||Risk difference (lanreotide Autogel - lanreotide PR) in the percentage of subjects with at least 20% reduction in the solid component of tumour volume compared to Baseline is presented.||13.3|-24.3|
72605813|NCT03718429|144740084|SUPERIORITY|In line with recommendations for pilot investigations, since there were no preliminary data exploring the pharmacodynamic effects of vascular dose rivaroxaban in addition to antiplatelet therapy, we arbitrarily chose a sample size of 20 patients per treatment cohort.||||||0.275|||||||Wilcoxon (Mann-Whitney)|||||||0.275
72605814|NCT03718429|144740085|SUPERIORITY|||||||0.488|||||||Wilcoxon (Mann-Whitney)|||||||0.488
72605815|NCT03718429|144740086|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
72605816|NCT00325819|144740093|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.66||||0.053|TWO_SIDED|95.0|0.41|1.01|||unadjusted Poisson regression|||The study sample size of 1000 children was selected to have 80% power to detect a 30% reduction in risk of the primary outcome of rectal temperature \>=38 following vaccination. In 2009, during the enrollment period of our trial, another paper reported the results of a randomized trial of acetaminophen prophylaxis in infants which found significantly lower immune responses to various vaccines in the acetaminophen group. In light of thse findings we elected to stop enrollment in our trial.||1.01|0.41|0.053
72605817|NCT00325819|144740094|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.0||||0.08||95.0|||||Fisher Exact|||||||0.08
72605818|NCT00325819|144740095|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.31||||0.02|TWO_SIDED|95.0|0.12|0.84|||unadjusted Poisson regression|||||0.84|0.12|0.02
72605819|NCT00325819|144740096|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.45||||0.14|TWO_SIDED|95.0|0.16|1.28|||unadjusted Poisson regression|||||1.28|0.16|0.14
72605820|NCT00325819|144740097|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.4||||0.001|TWO_SIDED|95.0|0.25|0.7|||unadjusted Poisson regression|||||0.70|0.25|0.001
72605821|NCT00325819|144740098|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.62||||0.4|TWO_SIDED|95.0|0.21|1.88|||unadjusted Poisson regression|||||1.88|0.21|0.40
72605822|NCT00325819|144740099|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.0||||1|TWO_SIDED|95.0|0.25|3.94|||unadjusted Poisson regression|||||3.94|0.25|1.00
72605823|NCT00325819|144740100|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|2.94||||0.18|TWO_SIDED|95.0|0.6|14.34|||unadjusted Poisson regression|||||14.34|0.60|0.18
72605824|NCT01466361|144740146|SUPERIORITY_OR_OTHER||Least square mean difference|-7.23||||0.0643|TWO_SIDED|95.0|-14.89|0.44|||ANCOVA||Treatment comparisons were made between nicotine 1.5mg lozenge and placebo lozenge at 5% significance level.|Null hypothesis considered population means for treatments in comparison, to be equal with respect to provoked nicotine cravings at 1 minute post dosing.||0.44|-14.89|0.0643
72605825|NCT01466361|144740146|SUPERIORITY_OR_OTHER||Least square mean difference|-7.16||||0.1489|TWO_SIDED|95.0|-16.93|2.61|||ANCOVA||Treatment comparisons were made between nicotine 1.5mg lozenge and placebo lozenge at 5% significance level.|Null hypothesis considered population means for treatments in comparison, to be equal with respect to provoked nicotine cravings at 3 minute post dosing.||2.61|-16.93|0.1489
72605826|NCT01466361|144740146|SUPERIORITY_OR_OTHER||Least square mean difference|-6.33||||0.2225|TWO_SIDED|95.0|-16.56|3.9|||ANCOVA||Treatment comparisons were made between 1.5mg nicotine lozenge and placebo lozenge at 5% significance level.|Null hypothesis considered population means for treatments in comparison, to be equal with respect to provoked nicotine cravings at 5 minute post dosing.||3.90|-16.56|0.2225
72605827|NCT01466361|144740146|SUPERIORITY_OR_OTHER||Least square mean difference|-5.11||||0.3491|TWO_SIDED|95.0|-15.87|5.66|||ANCOVA||Treatment comparisons were made between 1.5mg nicotine lozenge and placebo lozenge at 5% significance level.|Null hypothesis considered population means for treatments in comparison, to be equal with respect to provoked nicotine cravings, 10 minutes post dosing.||5.66|-15.87|0.3491
72605828|NCT01466361|144740146|SUPERIORITY_OR_OTHER||Least square mean difference|-5.0||||0.3936|TWO_SIDED|95.0|-16.6|6.59|||ANCOVA||Treatment comparisons were made between 1.5mg nicotine lozenge and placebo lozenge at 5% significance level.|Null hypothesis considered population means for treatments in comparison, to be equal with respect to provoked nicotine cravings, 15 minutes post dosing.||6.59|-16.60|0.3936
72605829|NCT01466361|144740147|SUPERIORITY_OR_OTHER||Least square mean difference|-3.58||||0.3922|TWO_SIDED|95.0|-11.85|4.7|||ANCOVA||Treatment comparisons were made between 4mg nicotine lozenge and placebo lozenge at 5% significance level.|Null hypothesis considered population means for treatments in comparison, to be equal with respect to provoked nicotine cravings, at 1 minute post dosing.||4.70|-11.85|0.3922
72605830|NCT01466361|144740147|SUPERIORITY_OR_OTHER||Least square mean difference|-9.7||||0.0547|TWO_SIDED|95.0|-19.59|0.2|||ANCOVA||Treatment comparisons were made between 4mg nicotine lozenge and placebo lozenge at 5% significance level.|Null hypothesis considered population means for treatments in comparison, to be equal with respect to provoked nicotine cravings, 3 minutes post dosing.||0.20|-19.59|0.0547
72605831|NCT03506438|144740178|SUPERIORITY||Mean Difference (Net)|-6.7||||0.018|TWO_SIDED|95.0|-12.2|-1.2|||Mixed Models Analysis|||||-1.2|-12.2|0.018
72605832|NCT03506438|144740179|SUPERIORITY||Mean Difference (Net)|0.3||||0.48|TWO_SIDED|95.0|-0.5|1.1|||Mixed Models Analysis|||||1.1|-0.5|0.48
72605833|NCT03506438|144740180|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.73|TWO_SIDED|95.0|-1.4|1.0|||Mixed Models Analysis|||||1.0|-1.4|0.73
72605834|NCT03506438|144740181|SUPERIORITY||estimated mean difference|0.6||||0.47|TWO_SIDED|95.0|-1.0|2.1|||Mixed Models Analysis|||||2.1|-1.0|0.47
72605835|NCT03506438|144740182|SUPERIORITY||Odds Ratio (OR)|1.8||||0.29|TWO_SIDED|95.0|0.6|5.2|||Regression, Logistic|||||5.2|0.6|0.29
72605836|NCT03506438|144740183|SUPERIORITY|||||||0.47|||||||Wilcoxon (Mann-Whitney)|||||||0.47
72605837|NCT03506438|144740184|SUPERIORITY|||||||0.39|||||||Wilcoxon (Mann-Whitney)|||||||0.39
72605838|NCT03506438|144740185|SUPERIORITY|||||||0.08|||||||Regression, Logistic|||||||0.08
72605839|NCT03527277|144740186|SUPERIORITY||Mean Difference (Net)|-1.5||||0.46|TWO_SIDED|95.0|-5.7|2.6|||ANCOVA|Effect of group on change in outcome with adjustment for BMI, Outcome at baseline and gender||||2.6|-5.7|0.46
72605840|NCT03527277|144740187|SUPERIORITY||Mean Difference (Net)|-0.1||||0.97|TWO_SIDED|95.0|-3.1|3.0|||ANCOVA|Effect of group on change with adjustment for gender and outcome and BMI at baseline.||||3.0|-3.1|0.97
72605841|NCT03527277|144740188|SUPERIORITY||Mean Difference (Net)|-0.7||||0.73|TWO_SIDED|95.0|-4.8|3.4|||ANCOVA|Effect of group with adjustment for gender and outcome and BMI at baseline.||||3.4|-4.8|0.73
72605842|NCT03527277|144740189|SUPERIORITY||Mean Difference (Net)|1.0||||0.54|TWO_SIDED|95.0|-2.2|4.2|||ANCOVA|Effect of group change with adjustment for gender and BMI and outcome at baseline.||||4.2|-2.2|0.54
72605843|NCT03527277|144740190|SUPERIORITY||Mean Difference (Net)|-0.92|||<|0.0001|TWO_SIDED|95.0|-1.34|-0.49|||ANCOVA|Effect of group with adjustment for gender and BMI and outcome at baseline.||||-0.49|-1.34|<0.0001
72605844|NCT03527277|144740191|SUPERIORITY||Mean Difference (Net)|-0.86|||<|0.0001|TWO_SIDED|95.0|-1.19|-0.53|||ANCOVA|Effect of group on change with adjustment for gender and BMI and outcome at baseline.||||-0.53|-1.19|<0.0001
72605845|NCT03527277|144740192|SUPERIORITY||Mean Difference (Net)|-0.38||||0.18|TWO_SIDED|95.0|-0.94|0.18|||ANCOVA|Effect of group on change with adjustment for gender and BMI and outcome at baseline.||||0.18|-0.94|0.18
72605846|NCT03527277|144740193|SUPERIORITY||Mean Difference (Net)|0.2||||0.49|TWO_SIDED|95.0|-0.38|0.77|||ANCOVA|Effect of group on change with adjustment for gender and BMI and outcome at baseline.||||0.77|-0.38|0.49
72605847|NCT03527277|144740194|SUPERIORITY||Mean Difference (Net)|-1.8||||0.66|TWO_SIDED|95.0|-10.1|6.5|||ANCOVA|Effect of group on change with adjustment of gender and BMI and outcome at baseline.||||6.5|-10.1|0.66
72605848|NCT03527277|144740195|SUPERIORITY||Mean Difference (Net)|-0.06||||0.78|TWO_SIDED|95.0|-0.06|0.35|||ANCOVA|Effect of group on change with adjustment for gender and outcome and BMI at baseline.||||0.35|-0.06|0.78
72605849|NCT03527277|144740196|SUPERIORITY||Mean Difference (Net)|0.03||||0.91|TWO_SIDED|95.0|-0.58|0.64|||ANCOVA|Effect of group on change with adjustment for gender and outcome and BMI at baseline.||||0.64|-0.58|0.91
72605850|NCT03527277|144740199|SUPERIORITY||Mean Difference (Net)|-7.9||||0.11|TWO_SIDED|95.0|-17.6|1.8|||ANCOVA|Effect of group on change with adjustment for gender and BMI and outcome at baseline.||||1.8|-17.6|0.11
72605851|NCT03527277|144740200|SUPERIORITY||Mean Difference (Net)|23340.0||||0.0032|TWO_SIDED|95.0|8284.0|38396.0|||ANCOVA|Effect of group on change with adjustment for gender and BMI and outcome at baseline.||||38396|8284|0.0032
72605852|NCT03527277|144740201|SUPERIORITY||Mean Difference (Net)|5558.0||||0.0003|TWO_SIDED|95.0|2680.0|8437.0|||ANCOVA|Effect of group on change with adjustment for gender and BMI and outcome at baseline.||||8437|2680|0.0003
72605853|NCT03527277|144740202|SUPERIORITY||Mean Difference (Net)|3824.0||||0.0012|TWO_SIDED|95.0|1611.0|6036.0|||ANCOVA|Effect of group on change with adjustment for gender and BMI and outcome at baseline||||6036|1611|0.0012
72605854|NCT03527277|144740203|SUPERIORITY||Mean Difference (Net)|19522.0||||0.0023|TWO_SIDED|95.0|7353.0|31691.0|||ANCOVA|Effect of group on change with adjustment for gender and BMI and outcome at baseline.||||31691|7353|0.0023
72605855|NCT03527277|144740204|SUPERIORITY||Mean Difference (Net)|21881.0||||0.0001|TWO_SIDED|95.0|11307.0|32455.0|||ANCOVA|Effect of group on change with adjustment for gender and BMI and outcome at baseline.||||32455|11307|0.0001
72605856|NCT03527277|144740205|SUPERIORITY||Mean Difference (Net)|9666.0||||0.0002|TWO_SIDED|95.0|4808.0|14524.0|||ANCOVA|Effect of group on change with adjustment for gender and BMI and outcome at baseline.||||14524|4808|0.0002
72605857|NCT03527277|144740206|SUPERIORITY||Mean Difference (Net)|3413.0||||0.0011|TWO_SIDED|95.0|1456.0|5370.0|||ANCOVA|Effect of group on change with adjustment for gender and BMI and outcome at baseline.||||5370|1456|0.0011
72605858|NCT03527277|144740207|SUPERIORITY||Mean Difference (Net)|11.6||||0.59|TWO_SIDED|95.0|-32.0|55.1|||ANCOVA|Effect of group on change with adjustment for gender and BMI and outcome at baseline.||||55.1|-32.0|0.59
72416298|NCT01972841|144343318|SUPERIORITY||Least squares mean difference|-0.26|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|95.0|-0.41|-0.11|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (solifenacin 5 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||-0.11|-0.41|<0.001
72416299|NCT01972841|144343318|SUPERIORITY||Least squares mean difference|-0.39|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|95.0|-0.54|-0.25|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (solifenacin 5 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||-0.25|-0.54|<0.001
72416300|NCT01972841|144343318|SUPERIORITY||Least squares mean difference|-0.35|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|95.0|-0.5|-0.2|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (mirabegron 25 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||-0.20|-0.50|<0.001
72416301|NCT01972841|144343318|SUPERIORITY||Least squares mean difference|-0.35|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|95.0|-0.5|-0.2|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (mirabegron 50 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||-0.20|-0.50|<0.001
72416302|NCT01972841|144343320|SUPERIORITY||Least squares mean difference|3.81|STANDARD_ERROR_OF_MEAN|1.08|<|0.001|TWO_SIDED|95.0|1.69|5.94|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (solifenacin 5 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||5.94|1.69|<0.001
72416303|NCT01972841|144343320|SUPERIORITY||Least squares mean difference|4.16|STANDARD_ERROR_OF_MEAN|1.09|<|0.001|TWO_SIDED|95.0|2.03|6.29|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (solifenacin 5 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||6.29|2.03|<0.001
72416304|NCT01972841|144343320|SUPERIORITY||Least squares mean difference|5.02|STANDARD_ERROR_OF_MEAN|1.09|<|0.001|TWO_SIDED|95.0|2.88|7.15|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (mirabegron 25 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||7.15|2.88|<0.001
72416305|NCT01972841|144343320|SUPERIORITY||Least squares mean difference|3.3|STANDARD_ERROR_OF_MEAN|1.09||0.002|TWO_SIDED|95.0|1.17|5.43|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (mirabegron 50 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||5.43|1.17|0.002
72605859|NCT03527277|144740208|SUPERIORITY||Mean Difference (Net)|79.0||||0.028|TWO_SIDED|95.0|9.8|148.6|||ANCOVA|Effect of group on change with adjustment for gender and BMI and outcome at baseline.||||148.6|9.8|0.028
72605860|NCT03527277|144740210|SUPERIORITY||Mean Difference (Net)|-0.8||||0.17|TWO_SIDED|95.0|-1.94|0.35|||ANCOVA|Effect of group on change with adjustment for gender and BMI and outcome at baseline.||||0.35|-1.94|0.17
72416306|NCT01972841|144343321|SUPERIORITY||Least squares mean difference|4.12|STANDARD_ERROR_OF_MEAN|1.29||0.001|TWO_SIDED|95.0|1.6|6.65|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (solifenacin 5 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||6.65|1.60|0.001
72605861|NCT03527277|144740211|SUPERIORITY||Mean Difference (Net)|0.54||||0.65|TWO_SIDED|95.0|-1.9|3.0|||ANCOVA|Effect of group on change with adjustment for gender and BMI and outcome at baseline.||||3.0|-1.9|0.65
72605862|NCT03527277|144740212|SUPERIORITY||Mean Difference (Net)|0.04||||0.88|TWO_SIDED|95.0|-0.5|0.6|||ANCOVA|Effect of group on change with adjustment for gender and outcome at baseline.||||0.6|-0.5|0.88
72605863|NCT03527277|144740213|SUPERIORITY||Mean Difference (Net)|0.6||||0.81|TWO_SIDED|95.0|-4.4|5.7|||ANCOVA|Effect of group on change with adjustment for gender and BMI and outcome at baseline.||||5.7|-4.4|0.81
72605864|NCT03527277|144740214|SUPERIORITY||Mean Difference (Net)|-0.7||||0.69|TWO_SIDED|95.0|-4.4|2.9|||ANCOVA|Effect of group on change with adjustment for gender and BMI and outcome at baseline.||||2.9|-4.4|0.69
72605865|NCT03527277|144740215|SUPERIORITY||Mean Difference (Net)|-0.4||||0.1|TWO_SIDED|95.0|-1.0|0.1|||ANCOVA|Effect of group on change with adjustment for gender and outcome at baseline.||||0.1|-1.0|0.10
72605866|NCT04155463|144740226|OTHER||Median Percent Change|-18.4||||0.17|TWO_SIDED||||||Wilcoxon signed rank test|Two-tailed test for paired data|This calculation shows the median percent change in urinary glyphosate concentrations going from the conventional diet to organic diet for all participants. Interquartile range for this was -37.4 to 29.8.|Based on previous pesticide research, we calculated a sample size of 40 participants to provide a power of 0.80 at a 0.05 significance level in a two-sided test. We assumed a standard deviation of 0.5 µg/L.||||0.17
72605867|NCT04155463|144740226|OTHER||Median Percent Change|-24.2||||0.06|TWO_SIDED||||||Wilcoxon signed rank test|Two-tailed test for paired data|This calculation shows the median percent change in urinary glyphosate concentrations going from the conventional diet to organic diet for far-field participants. Interquartile range for this was -37.4 to -8.8.|||||0.06
72605868|NCT04155463|144740226|OTHER||Median Percent Change|1.4||||0.83|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|Two-tailed test for paired data|This calculation shows the median percent change in urinary glyphosate concentrations going from the conventional diet to organic diet for near-field participants. Interquartile range for this was -41.9 to 43.0.|||||0.83
72605869|NCT01718483|144740256|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-1.35|||<|0.001|TWO_SIDED|95.0|-1.7|-1.01|||Mixed Models Repeated Measures Analysis|||||-1.01|-1.70|<0.001
72605870|NCT01718483|144740257|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Chi-squared|||||||<0.001
72605871|NCT01718483|144740258|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Chi-squared|||||||<0.001
72605872|NCT01718483|144740259|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-6.35|||<|0.001|TWO_SIDED|95.0|-7.17|-5.54|||Mixed Models Repeated Measures Analysis|||||-5.54|-7.17|<0.001
72605873|NCT01718483|144740260|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-7.4|||<|0.001|TWO_SIDED|95.0|-8.93|-5.88|||Mixed Models Repeated Measures Analysis|||||-5.88|-8.93|<0.001
72605874|NCT01718483|144740261|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.199|||<|0.001|TWO_SIDED|95.0|-0.31|-0.088|||ANCOVA|||||-0.088|-0.310|<0.001
72605875|NCT01718483|144740262|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.211|||<|0.001|TWO_SIDED|95.0|-0.33|-0.092|||ANCOVA|||||-0.092|-0.330|<0.001
72605876|NCT01718483|144740263|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.02||||0.308|TWO_SIDED|95.0|-0.07|0.02|||ANCOVA|||||0.02|-0.07|0.308
72605877|NCT01718483|144740264|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||Multiplicity is not adjusted for this secondary efficacy endpoint in this study.|Cochran-Mantel-Haenszel|||||||<0.001
72605878|NCT01718483|144740265|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-1.77|||<|0.001|TWO_SIDED|95.0|-2.24|-1.3||Multiplicity is not adjusted for this secondary efficacy endpoint in this study.|Mixed Models Repeated Measures Analysis|||||-1.30|-2.24|<0.001
72605879|NCT01718483|144740266|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|1.65|||<|0.001|TWO_SIDED|95.0|0.72|2.57||Multiplicity is not adjusted for this secondary efficacy endpoint in this study.|Mixed Models Repeated Measures Analysis|||Cognitive Restraint of Eating||2.57|0.72|<0.001
72605880|NCT01718483|144740266|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-4.19|||<|0.001|TWO_SIDED|95.0|-4.98|-3.39||Multiplicity is not adjusted for this secondary efficacy endpoint in this study.|Mixed Models Repeated Measures Analysis|||Disinhibition of Eating||-3.39|-4.98|<0.001
72605881|NCT01718483|144740266|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-4.7|||<|0.001|TWO_SIDED|95.0|-5.49|-3.91||Multiplicity is not adjusted for this secondary efficacy endpoint in this study.|Mixed Models Repeated Measures Analysis|||Perceived Hunger||-3.91|-5.49|<0.001
72605882|NCT01718483|144740267|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-10.32|||<|0.001|TWO_SIDED|95.0|-12.43|-8.21||Multiplicity is not adjusted for this secondary efficacy endpoint in this study.|Mixed Models Repeated Measures Analysis|||||-8.21|-12.43|<0.001
72605883|NCT01718483|144740268|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.31||||0.706|TWO_SIDED|95.0|-1.93|1.31||Multiplicity is not adjusted for this secondary efficacy endpoint in this study.|ANCOVA|||||1.31|-1.93|0.706
72605884|NCT00536510|144740291|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.7|STANDARD_ERROR_OF_MEAN|1.96|<|0.001||95.0|-18.6|-10.9||The significance test was 2-tailed with α=0.05|ANOVA|The efficacy analysis was performed using an ANOVA model with factors for treatment, country, gender, and stratum defined by concomitant statin use.||The primary hypothesis of superiority of MK0524A 2 g to placebo in lowering Low Density Lipoprotein Cholesterol (LDL-C) was assessed using the comparison between these 2 groups from the ANOVA model.||-10.9|-18.6|<0.001
72605885|NCT00536510|144740292|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|15.9|STANDARD_ERROR_OF_MEAN|1.68|<|0.001||95.0|12.6|19.2||The significance test was 2-tailed with α=0.05|ANOVA|The efficacy analysis was performed using an ANOVA model with factors for treatment, country, gender, and stratum defined by concomitant statin use.||The secondary hypothesis of superiority of MK0524A 2 g to placebo in lowering High Density Lipoprotein Cholesterol (HDL-C) was assessed using the comparison between these 2 groups from the ANOVA model.||19.2|12.6|<0.001
72605886|NCT00048035|144740301|SUPERIORITY_OR_OTHER||Estimated Conversion Factor 90% CI|0.38|||||TWO_SIDED|90.0|0.32|0.42|||||To analyze the appropriateness of the chosen dose conversion factors, a second regression analysis was carried out. This was a regression on the three different conversion factor dose groups, using the regression slope estimates of Hb.|All cohorts with dosing frequency 1 X / Week||0.42|0.32|
72605887|NCT00048035|144740301|SUPERIORITY_OR_OTHER||Estimated Conversion Factor 90% CI|0.61|||||TWO_SIDED|90.0|0.53|0.76|||||To analyze the appropriateness of the chosen dose conversion factors, a second regression analysis was carried out. This was a regression on the three different conversion factor dose groups, using the regression slope estimates of Hb change.|All cohorts with dosing frequency 1 X /2 Week||0.76|0.53|
72605888|NCT02035553|144740307|SUPERIORITY||Diff in MMRM LSM|-1.84||||0.0451|TWO_SIDED|95.0|-3.64|-0.04|||Mixed Models Analysis|||||-0.04|-3.64|0.0451
72416307|NCT01972841|144343321|SUPERIORITY||Lest squares mean difference|4.87|STANDARD_ERROR_OF_MEAN|1.29|<|0.001|TWO_SIDED|95.0|2.34|7.4|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (solifenacin 5 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||7.40|2.34|<0.001
72605889|NCT02326272|144740343|SUPERIORITY||Odds Ratio (OR)|33.405|||<|0.0001|TWO_SIDED|97.5|9.965|111.983||The p-value for the primary analysis was evaluated at a 2-sided significance level of 0.025 for each CZP dose versus (vs) placebo (PBO).|Regression, Logistic|Estimated responder rate, odds ratios, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.||The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||111.983|9.965|<0.0001
72605890|NCT02326272|144740343|SUPERIORITY||Estimated difference in responder rate|69.7|||||TWO_SIDED|95.0|57.12|82.36|||Regression, Logistic|Estimated responder rate, odds ratios, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.||The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||82.36|57.12|
72605891|NCT02326272|144740343|SUPERIORITY||Odds Ratio (OR)|36.212|||<|0.0001|TWO_SIDED|97.5|10.686|122.713||The p-value for the primary analysis was evaluated at a 2-sided significance level of 0.025 for each CZP dose vs PBO.|Regression, Logistic|Estimated responder rate, odds ratios, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.||The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||122.713|10.686|<0.0001
72605892|NCT02326272|144740343|SUPERIORITY||Estimated difference in responder rate|71.0|||||TWO_SIDED|95.0|58.47|83.43|||Regression, Logistic|Estimated responder rate, odds ratios, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.||The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||83.43|58.47|
72605893|NCT02326272|144740344|SUPERIORITY||Odds Ratio (OR)|106.225|||<|0.0001|TWO_SIDED|97.5|9.572|1178.843||The p-value for the primary analysis was evaluated at a 2-sided significance level of 0.025 for each CZP dose vs PBO.|Regression, Logistic|Estimated responder rate, odds ratios, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.||The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||1178.843|9.572|<0.0001
72605894|NCT02326272|144740344|SUPERIORITY||Estimated difference in responder rate|64.8|||||TWO_SIDED|95.0|52.16|77.46|||Regression, Logistic|Estimated responder rate, odds ratios, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.||The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||77.46|52.16|
72605895|NCT02326272|144740344|SUPERIORITY||Odds Ratio (OR)|133.163|||<|0.0001|TWO_SIDED|97.5|11.904|1489.578||The p-value for the primary analysis was evaluated at a 2-sided significance level of 0.025 for each CZP dose vs PBO.|Regression, Logistic|Estimated responder rate, odds ratios, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.||The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||1489.578|11.904|<0.0001
72605896|NCT02326272|144740344|SUPERIORITY||Estimated difference in responder rate|69.6|||||TWO_SIDED|95.0|57.48|81.77|||Regression, Logistic|Estimated responder rate, odds ratios, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.||The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||81.77|57.48|
72605897|NCT02326272|144740345|SUPERIORITY||Odds Ratio (OR)|24.283|||<|0.0001|TWO_SIDED|97.5|4.386|134.432||The p-value for this analysis as used in the fixed sequence testing procedure was evaluated at a 2-sided significance level of 0.025 for each CZP dose vs PBO.|Regression, Logistic|Estimated responder rate, odds ratios, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.||The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||134.432|4.386|<0.0001
72605898|NCT02326272|144740345|SUPERIORITY||Estimated difference in responder rate|48.1|||||TWO_SIDED|95.0|35.04|61.26|||Regression, Logistic|Estimated responder rate, odds ratios, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.||The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||61.26|35.04|
72605899|NCT02326272|144740345|SUPERIORITY||Odds Ratio (OR)|27.204|||<|0.0001|TWO_SIDED|97.5|4.895|151.198||The p-value for this analysis as used in the fixed sequence testing procedure was evaluated at a 2-sided significance level of 0.025 for each CZP dose vs PBO.|Regression, Logistic|Estimated responder rate, odds ratios, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.||The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||151.198|4.895|<0.0001
72605900|NCT02326272|144740345|SUPERIORITY||Estimated difference in responder rate|51.0|||||TWO_SIDED|95.0|37.75|64.19|||Regression, Logistic|Estimated responder rate, odds ratios, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.||The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||64.19|37.75|
72605901|NCT02326272|144740348|SUPERIORITY||Adjusted Mean Treatment Differences|-6.62|||<|0.0001|TWO_SIDED|97.5|-8.88|-4.36||The P-value was obtained for each treatment group comparison tested at a significance level of 0.025 in the fixed sequence testing procedure.|ANCOVA|ANCOVA model of change from Baseline DLQI score with treatment group, region, prior biologic exposure as factors; Baseline DLQI score as a covariate.||The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||-4.36|-8.88|<0.0001
72416308|NCT01972841|144343321|SUPERIORITY||Least squares mean difference|6.09|STANDARD_ERROR_OF_MEAN|1.3|<|0.001|TWO_SIDED|95.0|3.55|8.63|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (mirabegron 25 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||8.63|3.55|<0.001
72605902|NCT02326272|144740348|SUPERIORITY||Adjusted Mean Treatment Differences|-6.19|||<|0.0001|TWO_SIDED|97.5|-8.46|-3.93||The P-value was obtained for each treatment group comparison tested at a significance level of 0.025 in the fixed sequence testing procedure.|ANCOVA|ANCOVA model of change from Baseline DLQI score with treatment group, region, prior biologic exposure as factors; Baseline DLQI score as a covariate.||The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||-3.93|-8.46|<0.0001
72605903|NCT02185417|144740356|SUPERIORITY||Hazard Ratio (HR)|1.04||||0.45|TWO_SIDED|95.0|0.94|1.16|||Log Rank|||Primary analyses were performed with the use of unadjusted log-rank tests that were stratified according to VA health care system.||1.16|0.94|0.45
72605904|NCT00974311|144740363|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.63|||<|0.0001|TWO_SIDED|95.0|0.53|0.75|||Log Rank|Stratified by baseline Eastern Cooperative Oncology Group (ECOG) performance status and mean Brief Pain Inventory - Short Form score (Question #3).|Hazard Ratio and 95% confidence interval are from Cox regression model.|||0.75|0.53|<0.0001
72605905|NCT00974311|144740364|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.4|||<|0.0001|TWO_SIDED|95.0|0.35|0.47|||Log Rank|Stratified by baseline ECOG performance status and mean Brief Pain Inventory - Short Form score (Question #3).|Hazard Ratio and 95% confidence interval are from Cox regression model.|||0.47|0.35|<0.0001
72605906|NCT00974311|144740365|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.69||||0.0001|TWO_SIDED|95.0|0.566|0.835|||Log Rank|Stratified by baseline ECOG performance status and mean Brief Pain Inventory - Short Form score (Question #3).|Hazard Ratio and 95% confidence interval are from Cox regression model.|||0.835|0.566|0.0001
72605907|NCT00974311|144740366|SUPERIORITY_OR_OTHER||Difference in Percentage of Participants|24.9|||<|0.0001|TWO_SIDED|95.0|18.8|30.9|||Cochran-Mantel-Haenszel|Stratified by baseline ECOG performance status and mean Brief Pain Inventory - Short Form score (Question #3).|Confidence Interval based on standard normal approximation.|||30.9|18.8|<0.0001
72605908|NCT00974311|144740367|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.248|||<|0.0001|TWO_SIDED|95.0|0.204|0.303||Stratified by baseline ECOG performance status and mean Brief Pain Inventory - Short Form score (Question #3).|Log Rank||Hazard Ratio and 95% confidence interval are from Cox regression model.|||0.303|0.204|<0.0001
72605909|NCT00974311|144740368|SUPERIORITY_OR_OTHER||Difference in Rate of Pain Palliation|38.2||||0.0079|TWO_SIDED|95.0|19.4|57.0|||Cochran-Mantel-Haenszel|Stratified by baseline Eastern Cooperative Oncology Group performance status (0-1 vs. 2).|Confidence Interval based on standard normal approximation.|||57.0|19.4|0.0079
72605910|NCT05556148|144740378|OTHER||Mean Difference (Final Values)|-1.54||||0.2968|TWO_SIDED|95.0|-4.44|1.37|||Student's paired t-test|||Change from Baseline at Day 1||1.37|-4.44|0.2968
72605911|NCT05556148|144740378|OTHER||Mean Difference (Final Values)|-15.36|||<|0.0001|TWO_SIDED|95.0|-19.77|-10.95|||Student's paired t-test|||Change from Baseline at Day 2||-10.95|-19.77|<.0001
72605912|NCT05556148|144740378|OTHER||Mean Difference (Final Values)|-27.27|||<|0.0001|TWO_SIDED|95.0|-33.06|-21.49|||Student's paired t-test|||Change from Baseline at Day 3||-21.49|-33.06|<.0001
72605913|NCT05556148|144740378|OTHER||Mean Difference (Final Values)|-35.05|||<|0.0001|TWO_SIDED|95.0|-41.69|-28.41|||Student's paired t-test|||Change from Baseline at Day 4||-28.41|-41.69|<.0001
72605914|NCT05556148|144740378|OTHER||Mean Difference (Final Values)|-38.49|||<|0.0001|TWO_SIDED|95.0|-45.87|-31.11|||Student's paired t-test|||Change from Baseline at Day 5||-31.11|-45.87|<.0001
72605915|NCT05556148|144740378|OTHER||Mean Difference (Final Values)|-39.67|||<|0.0001|TWO_SIDED|95.0|-48.46|-30.88|||Student's paired t-test|||Change from Baseline at Day 6||-30.88|-48.46|<.0001
72605916|NCT05556148|144740378|OTHER||Mean Difference (Final Values)|-52.6|||<|0.0001|TWO_SIDED|95.0|-63.69|-41.51|||Student's paired t-test|||Change from Baseline at Day 7||-41.51|-63.69|<.0001
72605917|NCT05556148|144740379|OTHER||Mean Difference (Final Values)|0.29||||0.7112|TWO_SIDED|95.0|-1.27|1.86|||Student's paired t-test|||Change from Baseline at Day 1||1.86|-1.27|0.7112
72605918|NCT05556148|144740379|OTHER||Mean Difference (Final Values)|-6.21|||<|0.0001|TWO_SIDED|95.0|-8.51|-3.92|||Student's paired t-test|||Change from Baseline at Day 2||-3.92|-8.51|<.0001
72605919|NCT05556148|144740379|OTHER||Mean Difference (Final Values)|-12.11|||<|0.0001|TWO_SIDED|95.0|-15.0|-9.22|||Student's paired t-test|||Change from Baseline at Day 3||-9.22|-15.00|<.0001
72605920|NCT05556148|144740379|OTHER||Mean Difference (Final Values)|-15.98|||<|0.0001|TWO_SIDED|95.0|-19.24|-12.71|||Student's paired t-test|||Change from Baseline at Day 4||-12.71|-19.24|<.0001
72605921|NCT05556148|144740379|OTHER||Mean Difference (Final Values)|-19.44|||<|0.0001|TWO_SIDED|95.0|-23.29|-15.59|||Student's paired t-test|||Change from Baseline at Day 5||-15.59|-23.29|<.0001
72605922|NCT05556148|144740379|OTHER||Mean Difference (Final Values)|-19.36|||<|0.0001|TWO_SIDED|95.0|-24.03|-14.69|||Student's paired t-test|||Change from Baseline at Day 6||-14.69|-24.03|<.0001
72605923|NCT05556148|144740379|OTHER||Mean Difference (Final Values)|-25.4|||<|0.0001|TWO_SIDED|95.0|-31.87|-18.93|||Student's paired t-test|||Change from Baseline at Day 7||-18.93|-31.87|<.0001
72605924|NCT05556148|144740380|OTHER||Mean Difference (Final Values)|-1.83||||0.0481|TWO_SIDED|95.0|-3.64|-0.02|||Student's paired t-test|||Change from Baseline at Day 1||-0.02|-3.64|0.0481
72605925|NCT05556148|144740380|OTHER||Mean Difference (Final Values)|-9.14|||<|0.0001|TWO_SIDED|95.0|-11.74|-6.55|||Student's paired t-test|||Change from Baseline at Day 2||-6.55|-11.74|<.0001
72605926|NCT05556148|144740380|OTHER||Mean Difference (Final Values)|-15.16|||<|0.0001|TWO_SIDED|95.0|-18.44|-11.88|||Student's paired t-test|||Change from Baseline at Day 3||-11.88|-18.44|<.0001
72605927|NCT05556148|144740380|OTHER||Mean Difference (Final Values)|-19.07|||<|0.0001|TWO_SIDED|95.0|-22.84|-15.3|||Student's paired t-test|||Change from Baseline at Day 4||-15.30|-22.84|<.0001
72605928|NCT05556148|144740380|OTHER||Mean Difference (Final Values)|-19.05|||<|0.0001|TWO_SIDED|95.0|-23.35|-14.75|||Student's paired t-test|||Change from Baseline at Day 5||-14.75|-23.35|<.0001
72605929|NCT05556148|144740380|OTHER||Mean Difference (Final Values)|-20.31|||<|0.0001|TWO_SIDED|95.0|-25.7|-14.92|||Student's paired t-test|||Change from Baseline at Day 6||-14.92|-25.70|<.0001
72605930|NCT05556148|144740380|OTHER||Mean Difference (Final Values)|-27.2|||<|0.0001|TWO_SIDED|95.0|-32.48|-21.92|||Student's paired t-test|||Change from Baseline at Day 7||-21.92|-32.48|<.0001
72605931|NCT05556148|144740381|OTHER||Mean Difference (Final Values)|0.0||||1|TWO_SIDED|95.0|-0.31|0.31|||Student's paired t-test|||Change from Baseline at Day 1||0.31|-0.31|1.0000
72605932|NCT05556148|144740381|OTHER||Mean Difference (Final Values)|-0.63||||0.0003|TWO_SIDED|95.0|-0.97|-0.3|||Student's paired t-test|||Change from Baseline at Day 2||-0.30|-0.97|0.0003
72605933|NCT05556148|144740381|OTHER||Mean Difference (Final Values)|-1.1|||<|0.0001|TWO_SIDED|95.0|-1.5|-0.7|||Student's paired t-test|||Change from Baseline at Day 3||-0.70|-1.50|<.0001
72605934|NCT05556148|144740381|OTHER||Mean Difference (Final Values)|-1.72|||<|0.0001|TWO_SIDED|95.0|-2.2|-1.24|||Student's paired t-test|||Change from Baseline at Day 4||-1.24|-2.20|<.0001
72605935|NCT05556148|144740381|OTHER||Mean Difference (Final Values)|-1.75|||<|0.0001|TWO_SIDED|95.0|-2.33|-1.16|||Student's paired t-test|||Change from Baseline at Day 5||-1.16|-2.33|<.0001
72605936|NCT05556148|144740381|OTHER||Mean Difference (Final Values)|-1.9|||<|0.0001|TWO_SIDED|95.0|-2.51|-1.28|||Student's paired t-test|||Change from Baseline at Day 6||-1.28|-2.51|<.0001
72605937|NCT05556148|144740381|OTHER||Mean Difference (Final Values)|-2.47|||<|0.0001|TWO_SIDED|95.0|-3.29|-1.64|||Student's paired t-test|||Change from Baseline at Day 7||-1.64|-3.29|<.0001
72605938|NCT05556148|144740382|OTHER||Mean Difference (Final Values)|-0.39||||0.0023|TWO_SIDED|95.0|-0.64|-0.14|||Student's paired t-test|||Change from Baseline at Day 1||-0.14|-0.64|0.0023
72605939|NCT05556148|144740382|OTHER||Mean Difference (Final Values)|-1.47|||<|0.0001|TWO_SIDED|95.0|-1.82|-1.12|||Student's paired t-test|||Change from Baseline at Day 2||-1.12|-1.82|<.0001
72605940|NCT05556148|144740382|OTHER||Mean Difference (Final Values)|-1.99|||<|0.0001|TWO_SIDED|95.0|-2.4|-1.58|||Student's paired t-test|||Change from Baseline at Day 3||-1.58|-2.40|<.0001
72605941|NCT05556148|144740382|OTHER||Mean Difference (Final Values)|-2.43|||<|0.0001|TWO_SIDED|95.0|-2.86|-2.0|||Student's paired t-test|||Change from Baseline at Day 4||-2.00|-2.86|<.0001
72605942|NCT05556148|144740382|OTHER||Mean Difference (Final Values)|-3.0|||<|0.0001|TWO_SIDED|95.0|-3.51|-2.49|||Student's paired t-test|||Change from Baseline at Day 5||-2.49|-3.51|<.0001
72605943|NCT05556148|144740382|OTHER||Mean Difference (Final Values)|-2.77|||<|0.0001|TWO_SIDED|95.0|-3.36|-2.18|||Student's paired t-test|||Change from Baseline at Day 6||-2.18|-3.36|<.0001
72605944|NCT05556148|144740382|OTHER||Mean Difference (Final Values)|-3.33|||<|0.0001|TWO_SIDED|95.0|-4.1|-2.57|||Student's paired t-test|||Change from Baseline at Day 7||-2.57|-4.10|<.0001
72605945|NCT05556148|144740383|OTHER||Mean Difference (Final Values)|-0.11||||0.4495|TWO_SIDED|95.0|-0.4|0.18|||Student's paired t-test|||Change from Baseline at Day 1||0.18|-0.40|0.4495
72605946|NCT05556148|144740383|OTHER||Mean Difference (Final Values)|-0.87|||<|0.0001|TWO_SIDED|95.0|-1.19|-0.54|||Student's paired t-test|||Change from Baseline at Day 2||-0.54|-1.19|<.0001
72605947|NCT05556148|144740383|OTHER||Mean Difference (Final Values)|-1.21|||<|0.0001|TWO_SIDED|95.0|-1.59|-0.82|||Student's paired t-test|||Change from Baseline at Day 3||-0.82|-1.59|<.0001
72605948|NCT05556148|144740383|OTHER||Mean Difference (Final Values)|-1.59|||<|0.0001|TWO_SIDED|95.0|-2.05|-1.12|||Student's paired t-test|||Change from Baseline at Day 4||-1.12|-2.05|<.0001
72605949|NCT05556148|144740383|OTHER||Mean Difference (Final Values)|-1.86|||<|0.0001|TWO_SIDED|95.0|-2.4|-1.33|||Student's paired t-test|||Change from Baseline at Day 5||-1.33|-2.40|<.0001
72605950|NCT05556148|144740383|OTHER||Mean Difference (Final Values)|-1.85|||<|0.0001|TWO_SIDED|95.0|-2.45|-1.24|||Student's paired t-test|||Change from Baseline at Day 6||-1.24|-2.45|<.0001
72605951|NCT05556148|144740383|OTHER||Mean Difference (Final Values)|-2.47|||<|0.0001|TWO_SIDED|95.0|-3.19|-1.75|||Student's paired t-test|||Change from Baseline at Day 7||-1.75|-3.19|<.0001
72605952|NCT05556148|144740384|OTHER||Mean Difference (Final Values)|0.11||||0.4758|TWO_SIDED|95.0|-0.2|0.42|||Student's paired t-test|||Change from Baseline at Day 1||0.42|-0.20|0.4758
72605953|NCT05556148|144740384|OTHER||Mean Difference (Final Values)|-0.61||||0.0016|TWO_SIDED|95.0|-0.99|-0.24|||Student's paired t-test|||Change from Baseline at Day 2||-0.24|-0.99|0.0016
72605954|NCT05556148|144740384|OTHER||Mean Difference (Final Values)|-1.23|||<|0.0001|TWO_SIDED|95.0|-1.67|-0.79|||Student's paired t-test|||Change from Baseline at Day 3||-0.79|-1.67|<.0001
72605955|NCT05556148|144740384|OTHER||Mean Difference (Final Values)|-1.67|||<|0.0001|TWO_SIDED|95.0|-2.18|-1.16|||Student's paired t-test|||Change from Baseline at Day 4||-1.16|-2.18|<.0001
72416309|NCT01972841|144343321|SUPERIORITY||Least squares mean difference|3.8|STANDARD_ERROR_OF_MEAN|1.29||0.003|TWO_SIDED|95.0|1.27|6.33|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (mirabegron 50 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||6.33|1.27|0.003
72416310|NCT01972841|144343322|SUPERIORITY||Least squares mean difference|4.24|STANDARD_ERROR_OF_MEAN|1.22||0.001|TWO_SIDED|95.0|1.84|6.63|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (solifenacin 5 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||6.63|1.84|0.001
72416311|NCT01972841|144343322|SUPERIORITY||Least squares mean difference|4.82|STANDARD_ERROR_OF_MEAN|1.22|<|0.001|TWO_SIDED|95.0|2.42|7.22|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (solifenacin 5 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||7.22|2.42|<0.001
72416312|NCT01972841|144343322|SUPERIORITY||Least squares mean difference|5.34|STANDARD_ERROR_OF_MEAN|1.23|<|0.001|TWO_SIDED|95.0|2.93|7.75|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (mirabegron 25 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||7.75|2.93|<0.001
72416313|NCT01972841|144343322|SUPERIORITY||Least squares mean difference|4.41|STANDARD_ERROR_OF_MEAN|1.22|<|0.001|TWO_SIDED|95.0|2.01|6.81|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (mirabegron 50 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||6.81|2.01|<0.001
72416314|NCT01972841|144343323|SUPERIORITY||Least squares mean difference|4.42|STANDARD_ERROR_OF_MEAN|1.24|<|0.001|TWO_SIDED|95.0|1.98|6.85|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (solifenacin 5 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||6.85|1.98|<0.001
72605956|NCT05556148|144740384|OTHER||Mean Difference (Final Values)|-1.98|||<|0.0001|TWO_SIDED|95.0|-2.46|-1.51|||Student's paired t-test|||Change from Baseline at Day 5||-1.51|-2.46|<.0001
72605957|NCT05556148|144740384|OTHER||Mean Difference (Final Values)|-2.08|||<|0.0001|TWO_SIDED|95.0|-2.77|-1.39|||Student's paired t-test|||Change from Baseline at Day 6||-1.39|-2.77|<.0001
72605958|NCT05556148|144740384|OTHER||Mean Difference (Final Values)|-2.87|||<|0.0001|TWO_SIDED|95.0|-3.65|-2.08|||Student's paired t-test|||Change from Baseline at Day 7||-2.08|-3.65|<.0001
72605959|NCT05556148|144740385|OTHER||Mean Difference (Final Values)|-0.04||||0.8017|TWO_SIDED|95.0|-0.36|0.28|||Student's paired t-test|||Change from Baseline at Day 1||0.28|-0.36|0.8017
72605960|NCT05556148|144740385|OTHER||Mean Difference (Final Values)|-0.67||||0.0005|TWO_SIDED|95.0|-1.05|-0.3|||Student's paired t-test|||Change from Baseline at Day 2||-0.30|-1.05|0.0005
72605961|NCT05556148|144740385|OTHER||Mean Difference (Final Values)|-1.29|||<|0.0001|TWO_SIDED|95.0|-1.69|-0.89|||Student's paired t-test|||Change from Baseline at Day 3||-0.89|-1.69|<.0001
72605962|NCT05556148|144740385|OTHER||Mean Difference (Final Values)|-1.41|||<|0.0001|TWO_SIDED|95.0|-1.86|-0.97|||Student's paired t-test|||Change from Baseline at Day 4||-0.97|-1.86|<.0001
72605963|NCT05556148|144740385|OTHER||Mean Difference (Final Values)|-1.98|||<|0.0001|TWO_SIDED|95.0|-2.5|-1.47|||Student's paired t-test|||Change from Baseline at Day 5||-1.47|-2.50|<.0001
72605964|NCT05556148|144740385|OTHER||Mean Difference (Final Values)|-1.95|||<|0.0001|TWO_SIDED|95.0|-2.61|-1.29|||Student's paired t-test|||Change from Baseline at Day 6||-1.29|-2.61|<.0001
72605965|NCT05556148|144740385|OTHER||Mean Difference (Final Values)|-2.4|||<|0.0001|TWO_SIDED|95.0|-3.26|-1.54|||Student's paired t-test|||Change from Baseline at Day 7||-1.54|-3.26|<.0001
72605966|NCT05556148|144740386|OTHER||Mean Difference (Final Values)|0.03||||0.8311|TWO_SIDED|95.0|-0.25|0.31|||Student's paired t-test|||Change from Baseline at Day 1||0.31|-0.25|0.8311
72605967|NCT05556148|144740386|OTHER||Mean Difference (Final Values)|-0.41||||0.0313|TWO_SIDED|95.0|-0.78|-0.04|||Student's paired t-test|||Change from Baseline at Day 2||-0.04|-0.78|0.0313
72605968|NCT05556148|144740386|OTHER||Mean Difference (Final Values)|-0.84||||0.0003|TWO_SIDED|95.0|-1.28|-0.39|||Student's paired t-test|||Change from Baseline at Day 3||-0.39|-1.28|0.0003
72605969|NCT05556148|144740386|OTHER||Mean Difference (Final Values)|-1.05|||<|0.0001|TWO_SIDED|95.0|-1.51|-0.59|||Student's paired t-test|||Change from Baseline at Day 4||-0.59|-1.51|<.0001
72605970|NCT05556148|144740386|OTHER||Mean Difference (Final Values)|-1.2|||<|0.0001|TWO_SIDED|95.0|-1.74|-0.66|||Student's paired t-test|||Change from Baseline at Day 5||-0.66|-1.74|<.0001
72605971|NCT05556148|144740386|OTHER||Mean Difference (Final Values)|-1.05||||0.0018|TWO_SIDED|95.0|-1.69|-0.42|||Student's paired t-test|||Change from Baseline at Day 6||-0.42|-1.69|0.0018
72605972|NCT05556148|144740386|OTHER||Mean Difference (Final Values)|-1.27||||0.0041|TWO_SIDED|95.0|-2.1|-0.43|||Student's paired t-test|||Change from Baseline at Day 7||-0.43|-2.10|0.0041
72605973|NCT05556148|144740387|OTHER||Mean Difference (Final Values)|0.01||||0.938|TWO_SIDED|95.0|-0.25|0.27|||Student's paired t-test|||Change from Baseline at Day 1||0.27|-0.25|0.9380
72605974|NCT05556148|144740387|OTHER||Mean Difference (Final Values)|-0.37||||0.0416|TWO_SIDED|95.0|-0.72|-0.01|||Student's paired t-test|||Change from Baseline at Day 2||-0.01|-0.72|0.0416
72416315|NCT01972841|144343323|SUPERIORITY||Least squares mean difference|4.42|STANDARD_ERROR_OF_MEAN|1.24|<|0.001|TWO_SIDED|95.0|1.98|6.86|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (solifenacin 5 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||6.86|1.98|<0.001
72605975|NCT05556148|144740387|OTHER||Mean Difference (Final Values)|-0.96|||<|0.0001|TWO_SIDED|95.0|-1.29|-0.62|||Student's paired t-test|||Change from Baseline at Day 3||-0.62|-1.29|<.0001
72605976|NCT05556148|144740387|OTHER||Mean Difference (Final Values)|-1.18|||<|0.0001|TWO_SIDED|95.0|-1.6|-0.76|||Student's paired t-test|||Change from Baseline at Day 4||-0.76|-1.60|<.0001
72605977|NCT05556148|144740387|OTHER||Mean Difference (Final Values)|-1.76|||<|0.0001|TWO_SIDED|95.0|-2.25|-1.27|||Student's paired t-test|||Change from Baseline at Day 5||-1.27|-2.25|<.0001
72605978|NCT05556148|144740387|OTHER||Mean Difference (Final Values)|-1.69|||<|0.0001|TWO_SIDED|95.0|-2.33|-1.05|||Student's paired t-test|||Change from Baseline at Day 6||-1.05|-2.33|<.0001
72605979|NCT05556148|144740387|OTHER||Mean Difference (Final Values)|-2.3|||<|0.0001|TWO_SIDED|95.0|-3.08|-1.52|||Student's paired t-test|||Change from Baseline at Day 7||-1.52|-3.08|<.0001
72605980|NCT05556148|144740388|OTHER||Mean Difference (Final Values)|0.04||||0.7821|TWO_SIDED|95.0|-0.25|0.33|||Student's paired t-test|||Change from Baseline at Day 1||0.33|-0.25|0.7821
72605981|NCT05556148|144740388|OTHER||Mean Difference (Final Values)|-0.77|||<|0.0001|TWO_SIDED|95.0|-1.14|-0.39|||Student's paired t-test|||Change from Baseline at Day 2||-0.39|-1.14|<.0001
72605982|NCT05556148|144740388|OTHER||Mean Difference (Final Values)|-1.62|||<|0.0001|TWO_SIDED|95.0|-2.05|-1.19|||Student's paired t-test|||Change from Baseline at Day 3||-1.19|-2.05|<.0001
72605983|NCT05556148|144740388|OTHER||Mean Difference (Final Values)|-2.29|||<|0.0001|TWO_SIDED|95.0|-2.73|-1.86|||Student's paired t-test|||Change from Baseline at Day 4||-1.86|-2.73|<.0001
72605984|NCT05556148|144740388|OTHER||Mean Difference (Final Values)|-2.46|||<|0.0001|TWO_SIDED|95.0|-2.98|-1.94|||Student's paired t-test|||Change from Baseline at Day 5||-1.94|-2.98|<.0001
72605985|NCT05556148|144740388|OTHER||Mean Difference (Final Values)|-2.64|||<|0.0001|TWO_SIDED|95.0|-3.36|-1.92|||Student's paired t-test|||Change from Baseline at Day 6||-1.92|-3.36|<.0001
72605986|NCT05556148|144740388|OTHER||Mean Difference (Final Values)|-3.2|||<|0.0001|TWO_SIDED|95.0|-4.19|-2.21|||Student's paired t-test|||Change from Baseline at Day 7||-2.21|-4.19|<.0001
72605987|NCT05556148|144740389|OTHER||Mean Difference (Final Values)|0.44||||0.0003|TWO_SIDED|95.0|0.21|0.68|||Student's paired t-test|||Change from Baseline at Day 1||0.68|0.21|0.0003
72605988|NCT05556148|144740389|OTHER||Mean Difference (Final Values)|-0.07||||0.646|TWO_SIDED|95.0|-0.38|0.24|||Student's paired t-test|||Change from Baseline at Day 2||0.24|-0.38|0.6460
72605989|NCT05556148|144740389|OTHER||Mean Difference (Final Values)|-0.59||||0.0021|TWO_SIDED|95.0|-0.95|-0.22|||Student's paired t-test|||Change from Baseline at Day 3||-0.22|-0.95|0.0021
72605990|NCT05556148|144740389|OTHER||Mean Difference (Final Values)|-0.83||||0.0002|TWO_SIDED|95.0|-1.25|-0.41|||Student's paired t-test|||Change from Baseline at Day 4||-0.41|-1.25|0.0002
72605991|NCT05556148|144740389|OTHER||Mean Difference (Final Values)|-1.2|||<|0.0001|TWO_SIDED|95.0|-1.68|-0.73|||Student's paired t-test|||Change from Baseline at Day 5||-0.73|-1.68|<.0001
72605992|NCT05556148|144740389|OTHER||Mean Difference (Final Values)|-1.36||||0.0003|TWO_SIDED|95.0|-2.04|-0.68|||Student's paired t-test|||Change from Baseline at Day 6||-0.68|-2.04|0.0003
72605993|NCT05556148|144740389|OTHER||Mean Difference (Final Values)|-2.13|||<|0.0001|TWO_SIDED|95.0|-2.95|-1.32|||Student's paired t-test|||Change from Baseline at Day 7||-1.32|-2.95|<.0001
72605994|NCT05556148|144740390|OTHER||Mean Difference (Final Values)|0.2||||0.1074|TWO_SIDED|95.0|-0.04|0.45|||Student's paired t-test|||Change from Baseline at Day 1||0.45|-0.04|0.1074
72605995|NCT05556148|144740390|OTHER||Mean Difference (Final Values)|-0.35||||0.0364|TWO_SIDED|95.0|-0.67|-0.02|||Student's paired t-test|||Change from Baseline at Day 2||-0.02|-0.67|0.0364
72605996|NCT05556148|144740390|OTHER||Mean Difference (Final Values)|-1.29|||<|0.0001|TWO_SIDED|95.0|-1.68|-0.91|||Student's paired t-test|||Change from Baseline at Day 3||-0.91|-1.68|<.0001
72605997|NCT05556148|144740390|OTHER||Mean Difference (Final Values)|-1.8|||<|0.0001|TWO_SIDED|95.0|-2.25|-1.36|||Student's paired t-test|||Change from Baseline at Day 4||-1.36|-2.25|<.0001
72605998|NCT05556148|144740390|OTHER||Mean Difference (Final Values)|-2.24|||<|0.0001|TWO_SIDED|95.0|-2.78|-1.69|||Student's paired t-test|||Change from Baseline at Day 5||-1.69|-2.78|<.0001
72605999|NCT05556148|144740390|OTHER||Mean Difference (Final Values)|-2.08|||<|0.0001|TWO_SIDED|95.0|-2.7|-1.45|||Student's paired t-test|||Change from Baseline at Day 6||-1.45|-2.70|<.0001
72606000|NCT05556148|144740390|OTHER||Mean Difference (Final Values)|-2.97|||<|0.0001|TWO_SIDED|95.0|-3.84|-2.1|||Student's paired t-test|||Change from Baseline at Day 7||-2.10|-3.84|<.0001
72606001|NCT05556148|144740391|OTHER||Mean Difference (Final Values)|-1.88|||<|0.0001|TWO_SIDED|95.0|-2.33|-1.43|||Student's paired t-test|||Day 1||-1.43|-2.33|<.0001
72606002|NCT05556148|144740391|OTHER||Mean Difference (Final Values)|-2.45|||<|0.0001|TWO_SIDED|95.0|-2.9|-2.01|||Student's paired t-test|||Day 2||-2.01|-2.90|<.0001
72606003|NCT05556148|144740391|OTHER||Mean Difference (Final Values)|-2.9|||<|0.0001|TWO_SIDED|95.0|-3.41|-2.39|||Student's paired t-test|||Day 3||-2.39|-3.41|<.0001
72606004|NCT05556148|144740391|OTHER||Mean Difference (Final Values)|-3.3|||<|0.0001|TWO_SIDED|95.0|-3.82|-2.77|||Student's paired t-test|||Day 4||-2.77|-3.82|<.0001
72606005|NCT05556148|144740391|OTHER||Mean Difference (Final Values)|-2.95|||<|0.0001|TWO_SIDED|95.0|-3.53|-2.37|||Student's paired t-test|||Day 5||-2.37|-3.53|<.0001
72606006|NCT05556148|144740391|OTHER||Mean Difference (Final Values)|-3.26|||<|0.0001|TWO_SIDED|95.0|-3.98|-2.53|||Student's paired t-test|||Day 6||-2.53|-3.98|<.0001
72606007|NCT05556148|144740391|OTHER||Mean Difference (Final Values)|-3.12|||<|0.0001|TWO_SIDED|95.0|-4.08|-2.16|||Student's paired t-test|||Day 7||-2.16|-4.08|<.0001
72416316|NCT01972841|144343323|SUPERIORITY||Least squares mean difference|4.87|STANDARD_ERROR_OF_MEAN|1.25|<|0.001|TWO_SIDED|95.0|2.42|7.32|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (mirabegron 25 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||7.32|2.42|<0.001
72416317|NCT01972841|144343323|SUPERIORITY||Least squares mean difference|3.28|STANDARD_ERROR_OF_MEAN|1.24||0.008|TWO_SIDED|95.0|0.84|5.72|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (mirabegron 50 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||5.72|0.84|0.008
72416318|NCT01972841|144343324|SUPERIORITY||Least squares mean difference|2.27|STANDARD_ERROR_OF_MEAN|0.99||0.022|TWO_SIDED|95.0|0.33|4.21|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (solifenacin 5 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||4.21|0.33|0.022
72606008|NCT05556148|144740392|OTHER||Mean Difference (Final Values)|-1.72|||<|0.0001|TWO_SIDED|95.0|-2.14|-1.31|||Student's paired t-test|||Day 1||-1.31|-2.14|<.0001
72416319|NCT01972841|144343324|SUPERIORITY||Least squares mean difference|2.25|STANDARD_ERROR_OF_MEAN|0.99||0.023|TWO_SIDED|95.0|0.31|4.19|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (solifenacin 5 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||4.19|0.31|0.023
72416320|NCT01972841|144343324|SUPERIORITY||Least squares mean difference|2.8|STANDARD_ERROR_OF_MEAN|0.99||0.005|TWO_SIDED|95.0|0.85|4.74|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (mirabegron 25 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||4.74|0.85|0.005
72606009|NCT05556148|144740392|OTHER||Mean Difference (Final Values)|-2.12|||<|0.0001|TWO_SIDED|95.0|-2.55|-1.7|||Student's paired t-test|||Day 2||-1.70|-2.55|<.0001
72606010|NCT05556148|144740392|OTHER||Mean Difference (Final Values)|-2.3|||<|0.0001|TWO_SIDED|95.0|-2.71|-1.9|||Student's paired t-test|||Day 3||-1.90|-2.71|<.0001
72606011|NCT05556148|144740392|OTHER||Mean Difference (Final Values)|-2.76|||<|0.0001|TWO_SIDED|95.0|-3.23|-2.29|||Student's paired t-test|||Day 4||-2.29|-3.23|<.0001
72606012|NCT05556148|144740392|OTHER||Mean Difference (Final Values)|-2.85|||<|0.0001|TWO_SIDED|95.0|-3.31|-2.39|||Student's paired t-test|||Day 5||-2.39|-3.31|<.0001
72606013|NCT05556148|144740392|OTHER||Mean Difference (Final Values)|-3.18|||<|0.0001|TWO_SIDED|95.0|-3.72|-2.64|||Student's paired t-test|||Day 6||-2.64|-3.72|<.0001
72416321|NCT01972841|144343324|SUPERIORITY||Least squares mean difference|0.95|STANDARD_ERROR_OF_MEAN|0.99||0.337|TWO_SIDED|95.0|-0.99|2.89|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (mirabegron 50 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||2.89|-0.99|0.337
72606014|NCT05556148|144740392|OTHER||Mean Difference (Final Values)|-3.17|||<|0.0001|TWO_SIDED|95.0|-3.9|-2.43|||Student's paired t-test|||Day 7||-2.43|-3.90|<.0001
72606015|NCT05556148|144740393|OTHER||Mean Difference (Final Values)|-1.98|||<|0.0001|TWO_SIDED|95.0|-2.39|-1.57|||Student's paired t-test|||Day 1||-1.57|-2.39|<.0001
72606016|NCT05556148|144740393|OTHER||Mean Difference (Final Values)|-2.24|||<|0.0001|TWO_SIDED|95.0|-2.66|-1.81|||Student's paired t-test|||Day 2||-1.81|-2.66|<.0001
72606017|NCT05556148|144740393|OTHER||Mean Difference (Final Values)|-2.73|||<|0.0001|TWO_SIDED|95.0|-3.14|-2.32|||Student's paired t-test|||Day 3||-2.32|-3.14|<.0001
72606018|NCT05556148|144740393|OTHER||Mean Difference (Final Values)|-2.91|||<|0.0001|TWO_SIDED|95.0|-3.4|-2.43|||Student's paired t-test|||Day 4||-2.43|-3.40|<.0001
72606019|NCT05556148|144740393|OTHER||Mean Difference (Final Values)|-3.17|||<|0.0001|TWO_SIDED|95.0|-3.68|-2.66|||Student's paired t-test|||Day 5||-2.66|-3.68|<.0001
72416322|NCT01972841|144343337|SUPERIORITY||Odds Ratio (OR)|1.31||||0.035|TWO_SIDED|95.0|1.02|1.69|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline mean number of incontinence episodes per 24 hours during the last 3 days as a covariate.||1.69|1.02|0.035
72606020|NCT05556148|144740393|OTHER||Mean Difference (Final Values)|-3.28|||<|0.0001|TWO_SIDED|95.0|-4.02|-2.54|||Student's paired t-test|||Day 6||-2.54|-4.02|<.0001
72606021|NCT05556148|144740393|OTHER||Mean Difference (Final Values)|-3.47|||<|0.0001|TWO_SIDED|95.0|-4.24|-2.7|||Student's paired t-test|||Day 7||-2.70|-4.24|<.0001
72606022|NCT05556148|144740394|OTHER||Mean Difference (Final Values)|-1.96|||<|0.0001|TWO_SIDED|95.0|-2.37|-1.55|||Student's paired t-test|||Day 1||-1.55|-2.37|<.0001
72606023|NCT05556148|144740394|OTHER||Mean Difference (Final Values)|-2.42|||<|0.0001|TWO_SIDED|95.0|-2.83|-2.01|||Student's paired t-test|||Day 2||-2.01|-2.83|<.0001
72606024|NCT05556148|144740394|OTHER||Mean Difference (Final Values)|-2.97|||<|0.0001|TWO_SIDED|95.0|-3.41|-2.53|||Student's paired t-test|||Day 3||-2.53|-3.41|<.0001
72606025|NCT05556148|144740394|OTHER||Mean Difference (Final Values)|-3.34|||<|0.0001|TWO_SIDED|95.0|-3.81|-2.87|||Student's paired t-test|||Day 4||-2.87|-3.81|<.0001
72606026|NCT05556148|144740394|OTHER||Mean Difference (Final Values)|-3.36|||<|0.0001|TWO_SIDED|95.0|-3.84|-2.87|||Student's paired t-test|||Day 5||-2.87|-3.84|<.0001
72606027|NCT05556148|144740394|OTHER||Mean Difference (Final Values)|-3.23|||<|0.0001|TWO_SIDED|95.0|-3.91|-2.56|||Student's paired t-test|||Change from Baseline at Day 6||-2.56|-3.91|<.0001
72606028|NCT05556148|144740394|OTHER||Mean Difference (Final Values)|-3.7|||<|0.0001|TWO_SIDED|95.0|-4.48|-2.92|||Student's paired t-test|||Day 7||-2.92|-4.48|<.0001
72606029|NCT05556148|144740395|OTHER||Mean Difference (Final Values)|-1.76|||<|0.0001|TWO_SIDED|95.0|-2.17|-1.34|||Student's paired t-test|||Day 1||-1.34|-2.17|<.0001
72416323|NCT01972841|144343337|SUPERIORITY||Odds Ratio (OR)|1.4||||0.009|TWO_SIDED|95.0|1.09|1.81|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline mean number of incontinence episodes per 24 hours during the last 3 days as a covariate.||1.81|1.09|0.009
72606030|NCT05556148|144740395|OTHER||Mean Difference (Final Values)|-2.09|||<|0.0001|TWO_SIDED|95.0|-2.51|-1.67|||Student's paired t-test|||Day 2||-1.67|-2.51|<.0001
72606031|NCT05556148|144740395|OTHER||Mean Difference (Final Values)|-2.41|||<|0.0001|TWO_SIDED|95.0|-2.86|-1.97|||Student's paired t-test|||Day 3||-1.97|-2.86|<.0001
72606032|NCT05556148|144740395|OTHER||Mean Difference (Final Values)|-2.74|||<|0.0001|TWO_SIDED|95.0|-3.22|-2.27|||Student's paired t-test|||Day 4||-2.27|-3.22|<.0001
72606033|NCT05556148|144740395|OTHER||Mean Difference (Final Values)|-2.73|||<|0.0001|TWO_SIDED|95.0|-3.3|-2.16|||Student's paired t-test|||Day 5||-2.16|-3.30|<.0001
72606034|NCT05556148|144740395|OTHER||Mean Difference (Final Values)|-2.87|||<|0.0001|TWO_SIDED|95.0|-3.56|-2.19|||Student's paired t-test|||Day 6||-2.19|-3.56|<.0001
72606035|NCT05556148|144740395|OTHER||Mean Difference (Final Values)|-3.2|||<|0.0001|TWO_SIDED|95.0|-4.01|-2.39|||Student's paired t-test|||Day 7||-2.39|-4.01|<.0001
72606036|NCT05556148|144740396|OTHER||Mean Difference (Final Values)|-1.93|||<|0.0001|TWO_SIDED|95.0|-2.35|-1.51|||Student's paired t-test|||Day 1||-1.51|-2.35|<.0001
72606037|NCT05556148|144740396|OTHER||Mean Difference (Final Values)|-2.6|||<|0.0001|TWO_SIDED|95.0|-3.0|-2.2|||Student's paired t-test|||Day 2||-2.20|-3.00|<.0001
72606038|NCT05556148|144740396|OTHER||Mean Difference (Final Values)|-2.65|||<|0.0001|TWO_SIDED|95.0|-3.09|-2.22|||Student's paired t-test|||Day 3||-2.22|-3.09|<.0001
72606039|NCT05556148|144740396|OTHER||Mean Difference (Final Values)|-3.07|||<|0.0001|TWO_SIDED|95.0|-3.53|-2.62|||Student's paired t-test|||Day 4||-2.62|-3.53|<.0001
72606040|NCT05556148|144740396|OTHER||Mean Difference (Final Values)|-3.25|||<|0.0001|TWO_SIDED|95.0|-3.76|-2.75|||Student's paired t-test|||Day 5||-2.75|-3.76|<.0001
72606041|NCT05556148|144740396|OTHER||Mean Difference (Final Values)|-3.41|||<|0.0001|TWO_SIDED|95.0|-4.04|-2.78|||Student's paired t-test|||Day 6||-2.78|-4.04|<.0001
72606042|NCT05556148|144740396|OTHER||Mean Difference (Final Values)|-3.47|||<|0.0001|TWO_SIDED|95.0|-4.3|-2.64|||Student's paired t-test|||Day 7||-2.64|-4.30|<.0001
72606043|NCT05556148|144740397|OTHER||Mean Difference (Final Values)|-2.07|||<|0.0001|TWO_SIDED|95.0|-2.49|-1.66|||Student's paired t-test|||Day 1||-1.66|-2.49|<.0001
72606044|NCT05556148|144740397|OTHER||Mean Difference (Final Values)|-2.76|||<|0.0001|TWO_SIDED|95.0|-3.2|-2.33|||Student's paired t-test|||Day 2||-2.33|-3.20|<.0001
72606045|NCT05556148|144740397|OTHER||Mean Difference (Final Values)|-3.21|||<|0.0001|TWO_SIDED|95.0|-3.63|-2.78|||Student's paired t-test|||Day 3||-2.78|-3.63|<.0001
72606046|NCT05556148|144740397|OTHER||Mean Difference (Final Values)|-3.49|||<|0.0001|TWO_SIDED|95.0|-3.98|-3.0|||Student's paired t-test|||Day 4||-3.00|-3.98|<.0001
72606047|NCT05556148|144740397|OTHER||Mean Difference (Final Values)|-3.83|||<|0.0001|TWO_SIDED|95.0|-4.33|-3.33|||Student's paired t-test|||Day 5||-3.33|-4.33|<.0001
72606048|NCT05556148|144740397|OTHER||Mean Difference (Final Values)|-4.05|||<|0.0001|TWO_SIDED|95.0|-4.65|-3.46|||Student's paired t-test|||Day 6||-3.46|-4.65|<.0001
72606049|NCT05556148|144740397|OTHER||Mean Difference (Final Values)|-4.13|||<|0.0001|TWO_SIDED|95.0|-4.81|-3.46|||Student's paired t-test|||Day 7||-3.46|-4.81|<.0001
72606050|NCT05556148|144740398|OTHER||Mean Difference (Final Values)|-2.21|||<|0.0001|TWO_SIDED|95.0|-2.66|-1.77|||Student's paired t-test|||Day 1||-1.77|-2.66|<.0001
72606051|NCT05556148|144740398|OTHER||Mean Difference (Final Values)|-2.73|||<|0.0001|TWO_SIDED|95.0|-3.15|-2.31|||Student's paired t-test|||Day 2||-2.31|-3.15|<.0001
72606052|NCT05556148|144740398|OTHER||Mean Difference (Final Values)|-3.16|||<|0.0001|TWO_SIDED|95.0|-3.6|-2.73|||Student's paired t-test|||Day 3||-2.73|-3.60|<.0001
72606053|NCT05556148|144740398|OTHER||Mean Difference (Final Values)|-3.52|||<|0.0001|TWO_SIDED|95.0|-4.0|-3.05|||Student's paired t-test|||Day 4||-3.05|-4.00|<.0001
72606054|NCT05556148|144740398|OTHER||Mean Difference (Final Values)|-3.73|||<|0.0001|TWO_SIDED|95.0|-4.19|-3.27|||Student's paired t-test|||Day 5||-3.27|-4.19|<.0001
72606055|NCT05556148|144740398|OTHER||Mean Difference (Final Values)|-4.0|||<|0.0001|TWO_SIDED|95.0|-4.55|-3.45|||Student's paired t-test|||Day 6||-3.45|-4.55|<.0001
72606056|NCT05556148|144740398|OTHER||Mean Difference (Final Values)|-4.07|||<|0.0001|TWO_SIDED|95.0|-4.74|-3.39|||Student's paired t-test|||Day 7||-3.39|-4.74|<.0001
72606057|NCT00676403|144740410|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|37.3||||||95.0|0.1|157.7|||ED-50: Bootstrap Method||Non-convergence for the non-liner model occurred in some bootstrap samples which were not included in summarizing the ED50 distribution or confidence interval.|Dose response analysis ED 50: dose providing 50% of the maximal effect. Statistics were obtained from three parameter model Y = D + G\*exp(B\*dose) by bootstrapping 2000 data sets, where D = expected response of saturation (maximal effect), B = related to slope of the dose response mechanism (change in response relative to the change in dose), and D+G = expected response at zero dose.||157.7|0.1|
72606058|NCT00676403|144740410|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|123.9||||||95.0|0.4|523.9|||ED 90: Bootstrap Method||Non-convergence for the non-liner model occurred in some bootstrap samples which were not included in summarizing the ED90 distribution or confidence interval.|Dose response analysis ED 90: dose providing 90% of the maximal effect. Statistics were obtained from three parameter model Y = D + G\*exp(B\*dose) by bootstrapping 2000 data sets, where D = expected response of saturation (maximal effect), B = related to slope of the dose response mechanism (change in response relative to the change in dose), and D+G = expected response at zero dose.||523.9|0.4|
72606059|NCT00676403|144740410|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.1|STANDARD_ERROR_OF_MEAN|2.472||0.0983||95.0|-8.97|0.77|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. The repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.77|-8.97|0.0983
72606060|NCT00676403|144740410|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.03|STANDARD_ERROR_OF_MEAN|2.415||0.0966||95.0|-8.78|0.73|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. The repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.73|-8.78|0.0966
72606061|NCT00676403|144740410|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-8.29|STANDARD_ERROR_OF_MEAN|2.548||0.0013||95.0|-13.31|-3.28|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. The repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||-3.28|-13.31|0.0013
72606062|NCT00676403|144740410|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.16|STANDARD_ERROR_OF_MEAN|2.437||0.0353||95.0|-9.96|-0.36|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. The repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||-0.36|-9.96|0.0353
72606063|NCT00676403|144740410|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-8.53|STANDARD_ERROR_OF_MEAN|2.469||0.0006||95.0|-13.4|-3.67|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. The repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||-3.67|-13.40|0.0006
72606064|NCT00676403|144740411|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8784||95.0|||||Cochran-Mantel-Haenszel|||Week 6: Cochran-Mantel-Haenszel test for difference; p-value was adjusted for geographic region at each visit.||||0.8784
72606065|NCT00676403|144740411|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6767||95.0|||||Cochran-Mantel-Haenszel|||Week 6: Cochran-Mantel-Haenszel test for difference; p-value was adjusted for geographic region at each visit.||||0.6767
72606066|NCT00676403|144740411|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8955||95.0|||||Cochran-Mantel-Haenszel|||Week 6: Cochran-Mantel-Haenszel test for difference; p-value was adjusted for geographic region at each visit.||||0.8955
72606067|NCT00676403|144740411|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9505||95.0|||||Cochran-Mantel-Haenszel|||Week 6: Cochran-Mantel-Haenszel test for difference; p-value was adjusted for geographic region at each visit.||||0.9505
72606068|NCT00676403|144740411|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0466||95.0|||||Cochran-Mantel-Haenszel|||Week 6: Cochran-Mantel-Haenszel test for difference; p-value was adjusted for geographic region at each visit.||||0.0466
72606069|NCT00676403|144740412|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3876||95.0|||||Cochran-Mantel-Haenszel|||Week 1: Cochran-Mantel-Haenszel test for difference; p-value was adjusted for geographic region at each visit.||||0.3876
72606070|NCT00676403|144740412|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7959||95.0|||||Cochran-Mantel-Haenszel|||Week 1: Cochran-Mantel-Haenszel test for difference; p-value was adjusted for geographic region at each visit.||||0.7959
72606071|NCT00676403|144740412|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2032||95.0|||||Cochran-Mantel-Haenszel|||Week 1: Cochran-Mantel-Haenszel test for difference; p-value was adjusted for geographic region at each visit.||||0.2032
72606072|NCT00676403|144740412|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7032||95.0|||||Cochran-Mantel-Haenszel|||Week 1: Cochran-Mantel-Haenszel test for difference; p-value was adjusted for geographic region at each visit.||||0.7032
72606073|NCT00676403|144740412|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0551||95.0|||||Cochran-Mantel-Haenszel|||Week 1: Cochran-Mantel-Haenszel test for difference; p-value was adjusted for geographic region at each visit.||||0.0551
72606074|NCT00676403|144740412|SUPERIORITY_OR_OTHER_LEGACY|||||||0.41||95.0|||||Cochran-Mantel-Haenszel|||Week 2: Cochran-Mantel-Haenszel test for difference; p-value was adjusted for geographic region at each visit.||||0.4100
72606075|NCT00676403|144740412|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6524||95.0|||||Cochran-Mantel-Haenszel|||Week 2: Cochran-Mantel-Haenszel test for difference; p-value was adjusted for geographic region at each visit.||||0.6524
72606076|NCT00676403|144740412|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3219||95.0|||||Cochran-Mantel-Haenszel|||Week 2: Cochran-Mantel-Haenszel test for difference; p-value was adjusted for geographic region at each visit.||||0.3219
72606077|NCT00676403|144740412|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3509||95.0|||||Cochran-Mantel-Haenszel|||Week 2: Cochran-Mantel-Haenszel test for difference; p-value was adjusted for geographic region at each visit.||||0.3509
72416324|NCT01972841|144343337|SUPERIORITY||Odds Ratio (OR)|1.5||||0.002|TWO_SIDED|95.0|1.16|1.93|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline mean number of incontinence episodes per 24 hours during the last 3 days as a covariate.||1.93|1.16|0.002
72606078|NCT00676403|144740412|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0053||95.0|||||Cochran-Mantel-Haenszel|||Week 2: Cochran-Mantel-Haenszel test for difference; p-value was adjusted for geographic region at each visit.||||0.0053
72606079|NCT00676403|144740412|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9835||95.0|||||Cochran-Mantel-Haenszel|||Week 4: Cochran-Mantel-Haenszel test for difference; p-value was adjusted for geographic region at each visit.||||0.9835
72606080|NCT00676403|144740412|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6668||95.0|||||Cochran-Mantel-Haenszel|||Week 4: Cochran-Mantel-Haenszel test for difference; p-value was adjusted for geographic region at each visit.||||0.6668
72606081|NCT00676403|144740412|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2823||95.0|||||Cochran-Mantel-Haenszel|||Week 4: Cochran-Mantel-Haenszel test for difference; p-value was adjusted for geographic region at each visit.||||0.2823
72416325|NCT01972841|144343337|SUPERIORITY||Odds Ratio (OR)|1.34||||0.023|TWO_SIDED|95.0|1.04|1.73|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline mean number of incontinence episodes per 24 hours during the last 3 days as a covariate.||1.73|1.04|0.023
72416326|NCT01972841|144343338|SUPERIORITY||Odds Ratio (OR)|1.22||||0.224|TWO_SIDED|95.0|0.88|1.69|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline OAB-q subscale as a covariate.||1.69|0.88|0.224
72416327|NCT01972841|144343338|SUPERIORITY||Odds Ratio (OR)|1.42||||0.037|TWO_SIDED|95.0|1.02|1.96|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline OAB-q subscale as a covariate.||1.96|1.02|0.037
72416328|NCT01972841|144343338|SUPERIORITY||Odds Ratio (OR)|1.98|||<|0.001|TWO_SIDED|95.0|1.47|2.67|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline OAB-q subscale as a covariate.||2.67|1.47|<0.001
72416329|NCT01972841|144343338|SUPERIORITY||Odds Ratio (OR)|1.65||||0.002|TWO_SIDED|95.0|1.21|2.26|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline OAB-q subscale as a covariate.||2.26|1.21|0.002
72416330|NCT01972841|144343339|SUPERIORITY||Odds Ratio (OR)|1.29||||0.077|TWO_SIDED|95.0|0.97|1.72|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline OAB-q subscale as a covariate.||1.72|0.97|0.077
72606082|NCT00676403|144740412|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5687||95.0|||||Cochran-Mantel-Haenszel|||Week 4: Cochran-Mantel-Haenszel test for difference; p-value was adjusted for geographic region at each visit.||||0.5687
72606083|NCT00676403|144740412|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0043||95.0|||||Cochran-Mantel-Haenszel|||Week 4: Cochran-Mantel-Haenszel test for difference; p-value was adjusted for geographic region at each visit.||||0.0043
72606084|NCT00676403|144740412|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8662||95.0|||||Cochran-Mantel-Haenszel|||Week 6: Cochran-Mantel-Haenszel test for difference; p-value was adjusted for geographic region at each visit.||||0.8662
72606085|NCT00676403|144740412|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3656||95.0|||||Cochran-Mantel-Haenszel|||Week 6: Cochran-Mantel-Haenszel test for difference; p-value was adjusted for geographic region at each visit.||||0.3656
72606086|NCT00676403|144740412|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0806||95.0|||||Cochran-Mantel-Haenszel|||Week 6: Cochran-Mantel-Haenszel test for difference; p-value was adjusted for geographic region at each visit.||||0.0806
72606087|NCT00676403|144740412|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5381||95.0|||||Cochran-Mantel-Haenszel|||Week 6: Cochran-Mantel-Haenszel test for difference; p-value was adjusted for geographic region at each visit.||||0.5381
72606088|NCT00676403|144740412|SUPERIORITY_OR_OTHER_LEGACY|||||||0.009||95.0|||||Cochran-Mantel-Haenszel|||Week 6: Cochran-Mantel-Haenszel test for difference; p-value was adjusted for geographic region at each visit.||||0.0090
72606089|NCT00676403|144740412|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9748||95.0|||||Cochran-Mantel-Haenszel|||Last Observation Carried Forward: Cochran-Mantel-Haenszel test for difference; p-value was adjusted for geographic region at each visit.||||0.9748
72416331|NCT01972841|144343339|SUPERIORITY||Odds Ratio (OR)|1.15||||0.321|TWO_SIDED|95.0|0.87|1.53|||Logistic regression|||Odds ratio from a logistic regression model treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline OAB-q subscale as a covariate.||1.53|0.87|0.321
72606090|NCT00676403|144740412|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3936||95.0|||||Cochran-Mantel-Haenszel|||Last Observation Carried Forward: Cochran-Mantel-Haenszel test for difference; p-value was adjusted for geographic region at each visit.||||0.3936
72606091|NCT00676403|144740412|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1563||95.0|||||Cochran-Mantel-Haenszel|||Last Observation Carried Forward: Cochran-Mantel-Haenszel test for difference; p-value was adjusted for geographic region at each visit.||||0.1563
72606092|NCT00676403|144740412|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6357||95.0|||||Cochran-Mantel-Haenszel|||Last Observation Carried Forward: Cochran-Mantel-Haenszel test for difference; p-value was adjusted for geographic region at each visit.||||0.6357
72606093|NCT00676403|144740412|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0133||95.0|||||Cochran-Mantel-Haenszel|||Last Observation Carried Forward: Cochran-Mantel-Haenszel test for difference; p-value was adjusted for geographic region at each visit.||||0.0133
72606094|NCT00676403|144740413|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.6|STANDARD_ERROR_OF_MEAN|8.05||0.4133||95.0|-22.4|9.3|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||9.3|-22.4|0.4133
72606095|NCT00676403|144740413|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.4|STANDARD_ERROR_OF_MEAN|7.92||0.6676||95.0|-19.0|12.2|||Mixed Models Analysis|||Week 1: Conrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||12.2|-19.0|0.6676
72606096|NCT00676403|144740413|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|8.04||0.9355||95.0|-16.5|15.2|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||15.2|-16.5|0.9355
72606097|NCT00676403|144740413|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.6|STANDARD_ERROR_OF_MEAN|7.97||0.9355||95.0|-15.1|16.4|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||16.4|-15.1|0.9355
72606098|NCT00676403|144740413|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-10.5|STANDARD_ERROR_OF_MEAN|7.94||0.1895||95.0|-26.1|5.2|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||5.2|-26.1|0.1895
72606099|NCT00676403|144740413|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-11.9|STANDARD_ERROR_OF_MEAN|8.1||0.1443||95.0|-27.8|4.1|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||4.1|-27.8|0.1443
72606100|NCT00676403|144740413|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-8.4|STANDARD_ERROR_OF_MEAN|7.96||0.2946||95.0|-24.0|7.3|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||7.3|-24.0|0.2946
72606101|NCT00676403|144740413|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-7.4|STANDARD_ERROR_OF_MEAN|8.22||0.3686||95.0|-23.6|8.8|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||8.8|-23.6|0.3686
72606102|NCT00676403|144740413|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.1|STANDARD_ERROR_OF_MEAN|8.02||0.6079||95.0|-19.9|11.7|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||11.7|-19.9|0.6079
72606103|NCT00676403|144740413|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-25.5|STANDARD_ERROR_OF_MEAN|7.99||0.0016||95.0|-41.2|-9.7|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||-9.7|-41.2|0.0016
72606104|NCT00676403|144740413|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.3|STANDARD_ERROR_OF_MEAN|8.22||0.5976||95.0|-20.5|11.8|||Mixed Models Analysis|||Week 3: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||11.8|-20.5|0.5976
72606105|NCT00676403|144740413|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.5|STANDARD_ERROR_OF_MEAN|8.0||0.8527||95.0|-14.3|17.3|||Mixed Models Analysis|||Week 3: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||17.3|-14.3|0.8527
72606106|NCT00676403|144740413|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.2|STANDARD_ERROR_OF_MEAN|8.29||0.6973||95.0|-19.6|13.1|||Mixed Models Analysis|||Week 3: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||13.1|-19.6|0.6973
72606107|NCT00676403|144740413|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.2|STANDARD_ERROR_OF_MEAN|8.09||0.6895||95.0|-19.2|12.7|||Mixed Models Analysis|||Week 3: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||12.7|-19.2|0.6895
72416332|NCT01972841|144343339|SUPERIORITY||Odds Ratio (OR)|1.92|||<|0.001|TWO_SIDED|95.0|1.46|2.53|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline OAB-q subscale as a covariate.||2.53|1.46|<0.001
72606108|NCT00676403|144740413|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-19.1|STANDARD_ERROR_OF_MEAN|8.21||0.0209||95.0|-35.2|-2.9|||Mixed Models Analysis|||Week 3: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||-2.9|-35.2|0.0209
72606109|NCT00676403|144740413|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.8|STANDARD_ERROR_OF_MEAN|8.18||0.4084||95.0|-22.9|9.3|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||9.3|-22.9|0.4084
72606110|NCT00676403|144740413|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.8|STANDARD_ERROR_OF_MEAN|7.96||0.3958||95.0|-22.5|8.9|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||8.9|-22.5|0.3958
72606111|NCT00676403|144740413|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.6|STANDARD_ERROR_OF_MEAN|8.25||0.5776||95.0|-20.9|11.7|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||11.7|-20.9|0.5776
72416333|NCT01972841|144343339|SUPERIORITY||Odds Ratio (OR)|1.16||||0.294|TWO_SIDED|95.0|0.88|1.53|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline OAB-q subscale as a covariate.||1.53|0.88|0.294
72416334|NCT01972841|144343340|SUPERIORITY||Odds Ratio (OR)|1.17||||0.251|TWO_SIDED|95.0|0.89|1.53|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline mean number of incontinence episodes per 24 hours during the last 3 days as a covariate.||1.53|0.89|0.251
72416335|NCT01972841|144343340|SUPERIORITY||Odds Ratio (OR)|1.25||||0.107|TWO_SIDED|95.0|0.95|1.64|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline mean number of incontinence episodes per 24 hours during the last 3 days as a covariate.||1.64|0.95|0.107
72416336|NCT01972841|144343340|SUPERIORITY||Odds Ratio (OR)|1.59|||<|0.001|TWO_SIDED|95.0|1.23|2.07|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline mean number of incontinence episodes per 24 hours during the last 3 days as a covariate.||2.07|1.23|<0.001
72416337|NCT01972841|144343340|SUPERIORITY||Odds Ratio (OR)|1.41||||0.012|TWO_SIDED|95.0|1.08|1.85|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline mean number of incontinence episodes per 24 hours during the last 3 days as a covariate.||1.85|1.08|0.012
72416338|NCT01972841|144343341|SUPERIORITY||Odds Ratio (OR)|1.3||||0.044|TWO_SIDED|95.0|1.01|1.67|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline mean number of micturitions per 24 hours as a covariate.||1.67|1.01|0.044
72416339|NCT01972841|144343341|SUPERIORITY||Odds Ratio (OR)|1.43||||0.006|TWO_SIDED|95.0|1.11|1.84|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline mean number of micturitions per 24 hours as a covariate.||1.84|1.11|0.006
72416340|NCT01972841|144343341|SUPERIORITY||Odds Ratio (OR)|1.47||||0.004|TWO_SIDED|95.0|1.13|1.9|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline mean number of micturitions per 24 hours as a covariate.||1.90|1.13|0.004
72416341|NCT01972841|144343341|SUPERIORITY||Odds Ratio (OR)|1.6|||<|0.001|TWO_SIDED|95.0|1.23|2.08|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline mean number of micturitions per 24 hours as a covariate.||2.08|1.23|<0.001
72416342|NCT01972841|144343342|SUPERIORITY||Odds Ratio (OR)|1.47||||0.004|TWO_SIDED|95.0|1.13|1.92|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline mean number of incontinence episodes per 24 hours as a covariate.||1.92|1.13|0.004
72606112|NCT00676403|144740413|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.6|STANDARD_ERROR_OF_MEAN|8.06||0.5665||95.0|-20.5|11.3|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||11.3|-20.5|0.5665
72416343|NCT01972841|144343342|SUPERIORITY||Odds Ratio (OR)|1.62|||<|0.001|TWO_SIDED|95.0|1.24|2.11|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline mean number of incontinence episodes per 24 hours as a covariate.||2.11|1.24|<0.001
72416344|NCT01972841|144343342|SUPERIORITY||Odds Ratio (OR)|1.59||||0.001|TWO_SIDED|95.0|1.22|2.07|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline mean number of incontinence episodes per 24 hours as a covariate.||2.07|1.22|0.001
72416345|NCT01972841|144343342|SUPERIORITY||Odds Ratio (OR)|1.57||||0.001|TWO_SIDED|95.0|1.21|2.04|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline mean number of incontinence episodes per 24 hours as a covariate.||2.04|1.21|0.001
72416346|NCT01972841|144343343|SUPERIORITY||Odds Ratio (OR)|1.32||||0.065|TWO_SIDED|95.0|0.98|1.78|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline PPBC as a covariate.||1.78|0.98|0.065
72606113|NCT00676403|144740413|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-23.5|STANDARD_ERROR_OF_MEAN|8.13||0.0041||95.0|-39.6|-7.5|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||-7.5|-39.6|0.0041
72606114|NCT00676403|144740413|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-10.9|STANDARD_ERROR_OF_MEAN|8.22||0.1842||95.0|-27.1|5.2|||Mixed Models Analysis|||Week 5: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||5.2|-27.1|0.1842
72606115|NCT00676403|144740413|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.8|STANDARD_ERROR_OF_MEAN|8.0||0.8269||95.0|-17.5|14.0|||Mixed Models Analysis|||Week 5: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||14.0|-17.5|0.8269
72606116|NCT00676403|144740413|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-8.1|STANDARD_ERROR_OF_MEAN|8.34||0.3319||95.0|-24.5|8.3|||Mixed Models Analysis|||Week 5: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||8.3|-24.5|0.3319
72606117|NCT00676403|144740413|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.5|STANDARD_ERROR_OF_MEAN|8.09||0.7552||95.0|-13.4|18.5|||Mixed Models Analysis|||Week 5: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||18.5|-13.4|0.7552
72606118|NCT00676403|144740413|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-20.3|STANDARD_ERROR_OF_MEAN|8.16||0.0137||95.0|-36.3|-4.2|||Mixed Models Analysis|||Week 5: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||-4.2|-36.3|0.0137
72606119|NCT00676403|144740413|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-13.0|STANDARD_ERROR_OF_MEAN|8.22||0.1157||95.0|-29.2|3.2|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||3.2|-29.2|0.1157
72606120|NCT00676403|144740413|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-7.1|STANDARD_ERROR_OF_MEAN|8.04||0.3791||95.0|-22.9|8.7|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||8.7|-22.9|0.3791
72606121|NCT00676403|144740413|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-12.7|STANDARD_ERROR_OF_MEAN|8.39||0.1329||95.0|-29.2|3.9|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||3.9|-29.2|0.1329
72606122|NCT00676403|144740413|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.3|STANDARD_ERROR_OF_MEAN|8.09||0.7723||95.0|-13.6|18.3|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||18.3|-13.6|0.7723
72416347|NCT01972841|144343343|SUPERIORITY||Odds Ratio (OR)|1.68||||0.001|TWO_SIDED|95.0|1.24|2.27|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline PPBC as a covariate.||2.27|1.24|0.001
72416348|NCT01972841|144343343|SUPERIORITY||Odds Ratio (OR)|1.76|||<|0.001|TWO_SIDED|95.0|1.32|2.36|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline PPBC as a covariate.||2.36|1.32|<0.001
72606123|NCT00676403|144740413|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-22.5|STANDARD_ERROR_OF_MEAN|8.16||0.0063||95.0|-38.6|-6.4|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||-6.4|-38.6|0.0063
72416349|NCT01972841|144343343|SUPERIORITY||Odds Ratio (OR)|1.51||||0.007|TWO_SIDED|95.0|1.12|2.04|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline PPBC as a covariate.||2.04|1.12|0.007
72416350|NCT01972841|144343344|SUPERIORITY||Odds Ratio (OR)|1.44||||0.007|TWO_SIDED|95.0|1.11|1.87|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline PPBC as a covariate.||1.87|1.11|0.007
72416351|NCT01972841|144343344|SUPERIORITY||Odds Ratio (OR)|1.67|||<|0.001|TWO_SIDED|95.0|1.28|2.17|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline PPBC as a covariate.||2.17|1.28|<0.001
72416352|NCT01972841|144343344|SUPERIORITY||Odds Ratio (OR)|1.76|||<|0.001|TWO_SIDED|95.0|1.34|2.3|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline PPBC as a covariate.||2.30|1.34|<0.001
72416353|NCT01972841|144343344|SUPERIORITY||Odds Ratio (OR)|1.68|||<|0.001|TWO_SIDED|95.0|1.29|2.19|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline PPBC as a covariate.||2.19|1.29|<0.001
72606124|NCT00676403|144740414|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.35|STANDARD_ERROR_OF_MEAN|0.254||0.1715||95.0|-0.15|0.85|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.85|-0.15|0.1715
72606125|NCT00676403|144740414|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.07|STANDARD_ERROR_OF_MEAN|0.251||0.7944||95.0|-0.43|0.56|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.56|-0.43|0.7944
72606126|NCT00676403|144740414|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.33|STANDARD_ERROR_OF_MEAN|0.255||0.1994||95.0|-0.17|0.83|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.83|-0.17|0.1994
72606127|NCT00676403|144740414|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.23|STANDARD_ERROR_OF_MEAN|0.251||0.3652||95.0|-0.27|0.72|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.72|-0.27|0.3652
72606128|NCT00676403|144740414|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.5|STANDARD_ERROR_OF_MEAN|0.251||0.0481||95.0|0.0|0.99|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.99|0.00|0.0481
72606129|NCT00676403|144740414|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.3|STANDARD_ERROR_OF_MEAN|0.256||0.2501||95.0|-0.21|0.8|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.80|-0.21|0.2501
72606130|NCT00676403|144740414|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.16|STANDARD_ERROR_OF_MEAN|0.252||0.5191||95.0|-0.33|0.66|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.66|-0.33|0.5191
72606131|NCT00676403|144740414|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.46|STANDARD_ERROR_OF_MEAN|0.262||0.0817||95.0|-0.06|0.97|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.97|-0.06|0.0817
72416354|NCT01972841|144343345|SUPERIORITY||Odds Ratio (OR)|1.12||||0.381|TWO_SIDED|95.0|0.87|1.45|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors, and baseline mean number of incontinence episodes per 24 hours and baseline OAB-q symptom bother scale as covariates.||1.45|0.87|0.381
72416355|NCT01972841|144343345|SUPERIORITY||Odds Ratio (OR)|1.31||||0.04|TWO_SIDED|95.0|1.01|1.7|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors, and baseline mean number of incontinence episodes per 24 hours and baseline OAB-q symptom bother scale as covariates.||1.70|1.01|0.040
72416356|NCT01972841|144343345|SUPERIORITY||Odds Ratio (OR)|1.56||||0.001|TWO_SIDED|95.0|1.21|2.0|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors, and baseline mean number of incontinence episodes per 24 hours and baseline OAB-q symptom bother scale as covariates.||2.00|1.21|0.001
72416357|NCT01972841|144343345|SUPERIORITY||Odds Ratio (OR)|1.57||||0.001|TWO_SIDED|95.0|1.21|2.03|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors, and baseline mean number of incontinence episodes per 24 hours and baseline OAB-q symptom bother scale as covariates.||2.03|1.21|0.001
72416358|NCT01972841|144343346|SUPERIORITY||Odds Ratio (OR)|1.24||||0.095|TWO_SIDED|95.0|0.96|1.59|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors, and baseline mean number of incontinence episodes per 24 hours and baseline OAB-q HRQL total score as covariates.||1.59|0.96|0.095
72416359|NCT01972841|144343346|SUPERIORITY||Odds Ratio (OR)|1.26||||0.073|TWO_SIDED|95.0|0.98|1.62|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors, and baseline mean number of incontinence episodes per 24 hours and baseline OAB-q HRQL total score as covariates.||1.62|0.98|0.073
72606132|NCT00676403|144740414|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.4|STANDARD_ERROR_OF_MEAN|0.253||0.1146||95.0|-0.1|0.9|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.90|-0.10|0.1146
72416360|NCT01972841|144343346|SUPERIORITY||Odds Ratio (OR)|1.66|||<|0.001|TWO_SIDED|95.0|1.29|2.13|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors, and baseline mean number of incontinence episodes per 24 hours and baseline OAB-q HRQL total score as covariates.||2.13|1.29|<0.001
72416361|NCT01972841|144343346|SUPERIORITY||Odds Ratio (OR)|1.27||||0.067|TWO_SIDED|95.0|0.98|1.63|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors, and baseline mean number of incontinence episodes per 24 hours and baseline OAB-q HRQL total score as covariates.||1.63|0.98|0.067
72416362|NCT01972841|144343347|SUPERIORITY||Odds Ratio (OR)|1.18||||0.21|TWO_SIDED|95.0|0.91|1.52|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors, and baseline mean number of lncontinence episodes per 24 hours and baseline PPBC as covariates.||1.52|0.91|0.210
72416363|NCT01972841|144343347|SUPERIORITY||Odds Ratio (OR)|1.46||||0.004|TWO_SIDED|95.0|1.13|1.89|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors, and baseline mean number of lncontinence episodes per 24 hours and baseline PPBC as covariates.||1.89|1.13|0.004
72606133|NCT00676403|144740414|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.71|STANDARD_ERROR_OF_MEAN|0.253||0.0054||95.0|0.21|1.21|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||1.21|0.21|0.0054
72416364|NCT01972841|144343347|SUPERIORITY||Odds Ratio (OR)|1.59|||<|0.001|TWO_SIDED|95.0|1.23|2.06|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors, and baseline mean number of lncontinence episodes per 24 hours and baseline PPBC as covariates.||2.06|1.23|<0.001
72416365|NCT01972841|144343347|SUPERIORITY||Odds Ratio (OR)|1.59|||<|0.001|TWO_SIDED|95.0|1.23|2.05|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors, and baseline mean number of lncontinence episodes per 24 hours and baseline PPBC as covariates.||2.05|1.23|<0.001
72416366|NCT01972841|144343348|SUPERIORITY||Odds Ratio (OR)|1.13||||0.335|TWO_SIDED|95.0|0.88|1.46|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors, and baseline mean number of incontinence episodes per 24 hours, baseline OAB-q symptom bother scale and baseline PPBC as covariates.||1.46|0.88|0.335
72606134|NCT00676403|144740414|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.25|STANDARD_ERROR_OF_MEAN|0.261||0.3389||95.0|-0.26|0.76|||Mixed Models Analysis|||Week 3: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.76|-0.26|0.3389
72416367|NCT01972841|144343348|SUPERIORITY||Odds Ratio (OR)|1.4||||0.009|TWO_SIDED|95.0|1.09|1.81|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors, and baseline mean number of incontinence episodes per 24 hours, baseline OAB-q symptom bother scale and baseline PPBC as covariates.||1.81|1.09|0.009
72416368|NCT01972841|144343348|SUPERIORITY||Odds Ratio (OR)|1.56||||0.001|TWO_SIDED|95.0|1.21|2.02|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors, and baseline mean number of incontinence episodes per 24 hours, baseline OAB-q symptom bother scale and baseline PPBC as covariates.||2.02|1.21|0.001
72416369|NCT01972841|144343348|SUPERIORITY||Odds Ratio (OR)|1.71|||<|0.001|TWO_SIDED|95.0|1.33|2.21|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors, and baseline mean number of incontinence episodes per 24 hours, baseline OAB-q symptom bother scale and baseline PPBC as covariates.||2.21|1.33|<0.001
72416370|NCT01972841|144343349|SUPERIORITY||Odds Ratio (OR)|1.11||||0.416|TWO_SIDED|95.0|0.86|1.43|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors, and baseline mean number of incontinence episodes per 24 hours, baseline OAB-q HRQL total score and baseline PPBC as covariates.||1.43|0.86|0.416
72416371|NCT01972841|144343349|SUPERIORITY||Odds Ratio (OR)|1.23||||0.105|TWO_SIDED|95.0|0.96|1.59|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors, and baseline mean number of incontinence episodes per 24 hours, baseline OAB-q HRQL total score and baseline PPBC as covariates.||1.59|0.96|0.105
72416372|NCT01972841|144343349|SUPERIORITY||Odds Ratio (OR)|1.66|||<|0.001|TWO_SIDED|95.0|1.28|2.16|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors, and baseline mean number of incontinence episodes per 24 hours, baseline OAB-q HRQL total score and baseline PPBC as covariates.||2.16|1.28|<0.001
72606135|NCT00676403|144740414|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.17|STANDARD_ERROR_OF_MEAN|0.254||0.5079||95.0|-0.33|0.67|||Mixed Models Analysis|||Week 3: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.67|-0.33|0.5079
72606136|NCT00676403|144740414|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.53|STANDARD_ERROR_OF_MEAN|0.265||0.0453||95.0|0.01|1.05|||Mixed Models Analysis|||Week 3: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||1.05|0.01|0.0453
72416373|NCT01972841|144343349|SUPERIORITY||Odds Ratio (OR)|1.45||||0.005|TWO_SIDED|95.0|1.12|1.87|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors, and baseline mean number of incontinence episodes per 24 hours, baseline OAB-q HRQL total score and baseline PPBC as covariates.||1.87|1.12|0.005
72606137|NCT00676403|144740414|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.36|STANDARD_ERROR_OF_MEAN|0.256||0.1622||95.0|-0.15|0.86|||Mixed Models Analysis|||Week 3: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.86|-0.15|0.1622
72606138|NCT00676403|144740414|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.96|STANDARD_ERROR_OF_MEAN|0.262||0.0003||95.0|0.45|1.48|||Mixed Models Analysis|||Week 3: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||1.48|0.45|0.0003
72606139|NCT00676403|144740414|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.54|STANDARD_ERROR_OF_MEAN|0.26||0.0383||95.0|0.03|1.05|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||1.05|0.03|0.0383
72606140|NCT00676403|144740414|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.19|STANDARD_ERROR_OF_MEAN|0.253||0.4495||95.0|-0.31|0.69|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.69|-0.31|0.4495
72606141|NCT00676403|144740414|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.65|STANDARD_ERROR_OF_MEAN|0.263||0.0135||95.0|0.14|1.17|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||1.17|0.14|0.0135
72606142|NCT00676403|144740414|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.37|STANDARD_ERROR_OF_MEAN|0.254||0.1423||95.0|-0.13|0.87|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.87|-0.13|0.1423
72416374|NCT03712891|144343364|OTHER|t-test||||||0.12|||||||t-test, 2 sided|||||||0.12
72416375|NCT02308748|144343415|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.8||||0.025|TWO_SIDED|95.0|-25.2|-14.3||Adjustment for multiple comparisons was performed according to the Bonferroni method.|Mixed Models Analysis|||Change in QTc interval on the ECG measured in milliseconds when dofetilide is administered with mexiletine compared to when dofetilide is administered alone at evening dose on treatment day.||-14.3|-25.2|0.025
72416376|NCT02308748|144343415|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.7||||0.025|TWO_SIDED|95.0|-25.2|-14.1||Adjustment for multiple comparisons was performed according to the Bonferroni method.|Mixed Models Analysis|||Change in QTc interval on the ECG measured in milliseconds when dofetilide is administered with lidocaine compared to when dofetilide is administered alone at evening dose on treatment day.||-14.1|-25.2|0.025
72416377|NCT02308748|144343415|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-23.2||||0.025|TWO_SIDED|95.0|-28.0|-18.3||Adjustment for multiple comparisons was performed according to the Bonferroni method.|Mixed Models Analysis|||Change in J-Tpeakc interval on the ECG measured in milliseconds when dofetilide is administered with mexiletine compared to when dofetilide is administered alone at evening dose on treatment day.||-18.3|-28.0|0.025
72416378|NCT02308748|144343415|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-20.5||||0.025|TWO_SIDED|95.0|-25.5|-15.5||Adjustment for multiple comparisons was performed according to the Bonferroni method.|Mixed Models Analysis|||Change in J-Tpeakc interval on the ECG measured in milliseconds when dofetilide is administered with lidocaine compared to when dofetilide is administered alone at evening dose on treatment day.||-15.5|-25.5|0.025
72416379|NCT02308748|144343416|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.9||||0.025|TWO_SIDED|95.0|-1.0|6.7||Adjustment for multiple comparisons was performed according to the Bonferroni method.|Mixed Models Analysis|||||6.7|-1|0.025
72416380|NCT01565707|144343429|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Mean Difference|12.1|STANDARD_ERROR_OF_MEAN|6.0||0.046|TWO_SIDED|95.0|0.2|24.0|||ANCOVA|From an ANCOVA (analysis of covariance) model including treatment, geographic region \& gender as fixed effects \& the baseline value as a covariate.||"The following hypotheses were tested at the 2-sided significance level 0.05:~* H0: Change from baseline to EoT in mean MVV per micturition is the same for placebo and solifenacin succinate oral suspension~* H1: Change from baseline to EoT in mean MVV per micturition is not the same for placebo and solifenacin succinate oral suspension"||24.0|0.2|0.046
72416381|NCT01565707|144343429|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Mean Difference|-4.7|STANDARD_ERROR_OF_MEAN|15.7|||TWO_SIDED|95.0|-36.7|27.4|||||From an ANCOVA model including treatment, geographic region \& gender as fixed effects \& the baseline value as a covariate.|||27.4|-36.7|
72416382|NCT01565707|144343430|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Mean Difference|31.9|STANDARD_ERROR_OF_MEAN|13.9||0.024|TWO_SIDED|95.0|4.3|59.5|||ANCOVA|From an ANCOVA model including treatment, geographic region \& gender as fixed effects \& the baseline value as a covariate.||||59.5|4.3|0.024
72416383|NCT01565707|144343430|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Mean Difference|-17.3|STANDARD_ERROR_OF_MEAN|29.1|||TWO_SIDED|95.0|-76.5|41.9|||||From an ANCOVA model including treatment, geographic region \& gender as fixed effects \& the baseline value as a covariate.|||41.9|-76.5|
72416384|NCT01565707|144343431|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.2||0.763|TWO_SIDED|95.0|-0.3|0.4||P-value is from a rank ANCOVA analysis stratified by geographic region.|ANCOVA|From an ANCOVA model including treatment, geographic region \& gender as fixed effects \& the baseline value as a covariate.||||0.4|-0.3|0.763
72606143|NCT00676403|144740414|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.76|STANDARD_ERROR_OF_MEAN|0.259||0.0035||95.0|0.25|1.27|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||1.27|0.25|0.0035
72606144|NCT00676403|144740414|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.66|STANDARD_ERROR_OF_MEAN|0.261||0.0125||95.0|0.14|1.17|||Mixed Models Analysis|||Week 5: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||1.17|0.14|0.0125
72606145|NCT00676403|144740414|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.06|STANDARD_ERROR_OF_MEAN|0.254||0.8021||95.0|-0.44|0.56|||Mixed Models Analysis|||Week 5: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.56|-0.44|0.8021
72606146|NCT00676403|144740414|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.6|STANDARD_ERROR_OF_MEAN|0.267||0.0249||95.0|0.08|1.13|||Mixed Models Analysis|||Week 5: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||1.13|0.08|0.0249
72416385|NCT01565707|144343431|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.4|||TWO_SIDED|95.0|-0.8|1.0|||||From an ANCOVA model including treatment, geographic region \& gender as fixed effects \& the baseline value as a covariate.|||1.0|-0.8|
72606147|NCT00676403|144740414|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.25|STANDARD_ERROR_OF_MEAN|0.256||0.3383||95.0|-0.26|0.75|||Mixed Models Analysis|||Week 5: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.75|-0.26|0.3383
72416386|NCT01565707|144343432|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.2||0.402|TWO_SIDED|95.0|-0.5|0.3||P-value is from a rank ANCOVA analysis stratified by geographic region.|ANCOVA|From an ANCOVA model including treatment, geographic region \& gender as fixed effects \& the baseline value as a covariate.||||0.3|-0.5|0.402
72416387|NCT01565707|144343432|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.5|||TWO_SIDED|95.0|-1.5|0.4|||||From an ANCOVA model including treatment, geographic region \& gender as fixed effects \& the baseline value as a covariate.|||0.4|-1.5|
72416388|NCT01565707|144343433|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.1||0.63|TWO_SIDED|95.0|0.0|0.2||P-value is from a rank ANCOVA analysis stratified by geographic region.|ANCOVA|From an ANCOVA model including treatment, geographic region \& gender as fixed effects \& the baseline value as a covariate.||||0.2|0.0|0.630
72416389|NCT01565707|144343433|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.1|||TWO_SIDED|95.0|-0.2|0.2|||||From an ANCOVA model including treatment, geographic region \& gender as fixed effects \& the baseline value as a covariate..|||0.2|-0.2|
72416390|NCT01565707|144343434|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.3||0.563|TWO_SIDED|95.0|-1.0|0.3||P-value is from a rank ANCOVA analysis stratified by geographic region.|ANCOVA|From an ANCOVA model including treatment, geographic region \& gender as fixed effects \& the baseline value as a covariate.||||0.3|-1.0|0.563
72416391|NCT01565707|144343434|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.8|||TWO_SIDED|95.0|-1.6|1.9|||||From an ANCOVA model including treatment, geographic region \& gender as fixed effects \& the baseline value as a covariate.|||1.9|-1.6|
72416392|NCT01565707|144343435|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.3||0.77|TWO_SIDED|95.0|-0.9|0.3||P-value is from a rank ANCOVA analysis stratified by geographic region.|ANCOVA|From an ANCOVA model including treatment, geographic region \& gender as fixed effects \& the baseline value as a covariate.||||0.3|-0.9|0.770
72416393|NCT01565707|144343435|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Mean Difference|0.5|STANDARD_ERROR_OF_MEAN|0.4|||TWO_SIDED|95.0|-0.4|1.3|||||From an ANCOVA model including treatment, geographic region \& gender as fixed effects \& the baseline value as a covariate.|||1.3|-0.4|
72416394|NCT01565707|144343436|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.2||0.303|TWO_SIDED|95.0|-0.8|0.2||From an ANCOVA model including treatment, geographic region \& gender as fixed effects \& the baseline value as a covariate.|ANCOVA|||||0.2|-0.8|0.303
72416395|NCT01565707|144343436|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.5|||TWO_SIDED|95.0|-0.9|1.1|||||From an ANCOVA model including treatment, geographic region \& gender as fixed effects \& the baseline value as a covariate.|||1.1|-0.9|
72416396|NCT01565707|144343437|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.3||0.64|TWO_SIDED|95.0|-0.8|0.5|||ANCOVA|From an ANCOVA model including treatment, geographic region \& gender as fixed effects \& the baseline value as a covariate.||||0.5|-0.8|0.640
72416397|NCT01565707|144343437|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|0.6|||TWO_SIDED|95.0|-0.9|1.4|||||From an ANCOVA model including treatment, geographic region \& gender as fixed effects \& the baseline value as a covariate.|||1.4|-0.9|
72416398|NCT01565707|144343438|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.1||0.846|TWO_SIDED|95.0|-0.3|0.1||P-value is from a rank ANCOVA analysis stratified by geographic region.|ANCOVA|From an ANCOVA model including treatment, geographic region \& gender as fixed effects \& the baseline value as a covariate.||||0.1|-0.3|0.846
72606148|NCT00676403|144740414|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.06|STANDARD_ERROR_OF_MEAN|0.26||0.0001||95.0|0.55|1.57|||Mixed Models Analysis|||Week 5: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||1.57|0.55|0.0001
72606149|NCT00676403|144740414|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.65|STANDARD_ERROR_OF_MEAN|0.261||0.0133||95.0|0.14|1.17|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||1.17|0.14|0.0133
72416399|NCT01565707|144343438|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.4|||TWO_SIDED|95.0|-1.0|0.5|||||From an ANCOVA model including treatment, geographic region \& gender as fixed effects \& the baseline value as a covariate.|||0.5|-1.0|
72416400|NCT01565707|144343439|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.5|||TWO_SIDED|95.0|-1.4|0.8|||||From an ANCOVA model including treatment, geographic region \& gender as fixed effects \& the baseline value as a covariate.|||0.8|-1.4|
72416401|NCT00866840|144343470|OTHER|||||||||||||||||No objective responses were seen in the first phase and accrual was stopped.|No objective responses were seen in the first phase and accrual was stopped.|||
72416402|NCT02625623|144343473|SUPERIORITY||Hazard Ratio (HR)|1.11||||0.8078|TWO_SIDED|95.0|0.88|1.41|||Log Rank|The treatment arms were compared using a stratified, 1-sided, log rank Test. The stratification factor was region (Asia versus non Asia).||||1.41|0.88|0.8078
72416403|NCT02625623|144343474|SUPERIORITY||Hazard Ratio (HR)|1.73||||1|TWO_SIDED|95.0|1.36|2.21|||Log Rank|The treatment arms were compared using a stratified, 1-sided, log rank Test. The stratification factor was region (Asia versus non Asia).||||2.21|1.36|1.0000
72416404|NCT02625623|144343476|SUPERIORITY||Odds Ratio (OR)|0.709||||0.8764|||||||Cochran-Mantel-Haenszel|The treatment arms were compared by 1-sided CMH test. The stratification factor was region (Asia versus non Asia).||||||0.8764
72416405|NCT02352948|144343481|OTHER|Sub-study A was not powered and thus no formal statistical comparisons were performed.|Hazard Ratio (HR)|0.63|||||TWO_SIDED|95.0|0.42|0.93|||||Hazard ratio and CI are estimated from a stratified Cox proportional hazards model with Breslow method to control for ties, stratification factors SoC therapy, and histology in strata statement, and CI is calculated using profile likelihood approach.|For sub-study A: durvalumab monotherapy treatment arm was compared with SoC.||0.93|0.42|
72416406|NCT02352948|144343481|SUPERIORITY||Hazard Ratio (HR)|0.8||||0.109|TWO_SIDED|95.0|0.61|1.05|||Log Rank|The P-value arises from a stratified log-rank test adjusting for SoC therapy and histology, with ties handled by the Breslow approach.|Hazard ratio and CI are estimated from a stratified Cox proportional hazards model with Breslow method to control for ties, stratification factors SoC therapy, and histology in strata statement, and CI is calculated using profile likelihood approach.|For sub-study B: durvalumab plus tremelimumab treatment arm was compared with SoC.||1.05|0.61|0.109
72606150|NCT00676403|144740414|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.22|STANDARD_ERROR_OF_MEAN|0.256||0.382||95.0|-0.28|0.73|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.73|-0.28|0.3820
72606151|NCT00676403|144740414|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.75|STANDARD_ERROR_OF_MEAN|0.269||0.0053||95.0|0.23|1.28|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||1.28|0.23|0.0053
72606152|NCT00676403|144740414|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.25|STANDARD_ERROR_OF_MEAN|0.256||0.3258||95.0|-0.25|0.76|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.76|-0.25|0.3258
72606153|NCT00676403|144740414|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.92|STANDARD_ERROR_OF_MEAN|0.26||0.0005||95.0|0.41|1.43|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||1.43|0.41|0.0005
72606154|NCT00676403|144740415|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.3||0.1429||95.0|-1.0|0.1|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.1|-1.0|0.1429
72606155|NCT00676403|144740415|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.3||0.0547||95.0|-1.2|0.0|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.0|-1.2|0.0547
72606156|NCT00676403|144740415|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.8|STANDARD_ERROR_OF_MEAN|0.3||0.0095||95.0|-1.4|-0.2|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||-0.2|-1.4|0.0095
72606157|NCT00676403|144740415|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.3||0.3676||95.0|-0.9|0.3|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.3|-0.9|0.3676
72606158|NCT00676403|144740415|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.3||0.2959||95.0|-0.9|0.3|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.3|-0.9|0.2959
72606159|NCT00676403|144740415|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.3||0.3435||95.0|-0.9|0.3|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.3|-0.9|0.3435
72606160|NCT00676403|144740415|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|0.3||0.0895||95.0|-1.1|0.1|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.1|-1.1|0.0895
72606161|NCT00676403|144740415|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|0.31||0.0844||95.0|-1.1|0.1|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.1|-1.1|0.0844
72416407|NCT02352948|144343482|OTHER|Sub-study A was not powered and thus no formal statistical comparisons were performed.|Hazard Ratio (HR)|0.71|||||TWO_SIDED|95.0|0.49|1.04|||||Hazard ratio and CI are estimated from a stratified Cox proportional hazards model with Breslow method to control for ties, stratification factors SoC therapy, and histology in strata statement, and CI is calculated using profile likelihood approach.|For sub-study A: durvalumab monotherapy treatment arm was compared with SoC.||1.04|0.49|
72416408|NCT02352948|144343482|SUPERIORITY||Hazard Ratio (HR)|0.77||||0.056|TWO_SIDED|95.0|0.59|1.01|||Log Rank|The P-value arises from a stratified log-rank test adjusting for SoC therapy and histology, with ties handled by the Breslow approach.|Hazard ratio and CI are estimated from a stratified Cox proportional hazards model with Breslow method to control for ties, stratification factors SoC therapy, and histology in strata statement, and CI is calculated using profile likelihood approach.|For sub-study B: durvalumab plus tremelimumab treatment arm was compared with SoC.||1.01|0.59|0.056
72416409|NCT02352948|144343483|SUPERIORITY||Hazard Ratio (HR)|0.98||||0.885|TWO_SIDED|95.0|0.74|1.3|||Log Rank|The P-value arises from a stratified log-rank test adjusting for SoC therapy and histology, with ties handled by the Breslow approach.|Hazard ratio and CI are estimated from a stratified Cox proportional hazards model with Breslow method to control for ties, stratification factors SoC therapy, and histology in strata statement, and CI is calculated using profile likelihood approach.|As part of the contribution of components analysis for sub-study B, durvalumab plus tremelimumab treatment arm was compared with durvalumab monotherapy.||1.30|0.74|0.885
72416410|NCT02352948|144343483|SUPERIORITY||Hazard Ratio (HR)|0.78||||0.153|TWO_SIDED|95.0|0.56|1.11|||Log Rank|The P-value arises from a stratified log-rank test adjusting for SoC therapy and histology, with ties handled by the Breslow approach.|Hazard ratio and CI are estimated from a stratified Cox proportional hazards model with Breslow method to control for ties, stratification factors SoC therapy, and histology in strata statement, and CI is calculated using profile likelihood approach.|As part of the contribution of components analysis for sub-study B, durvalumab plus tremelimumab treatment arm was compared with tremelimumab monotherapy.||1.11|0.56|0.153
72416411|NCT02352948|144343484|SUPERIORITY|||||||0.063||||||The z-test statistic is the ratio of log-transformed ratio of the cumulative hazards in the 2 treatment arms divided by square root of the variance.|z-test|The variance is estimated using the delta method and Greenwood's formula.||For sub-study B: durvalumab plus tremelimumab treatment arm was compared with SoC.||||0.063
72416412|NCT02352948|144343485|SUPERIORITY||Hazard Ratio (HR)|0.87||||0.282|TWO_SIDED|95.0|0.68|1.12|||Log Rank|The P-value arises from a stratified log-rank test adjusting for SoC therapy and histology, with ties handled by the Breslow approach.|Hazard ratio and CI are estimated from a stratified Cox proportional hazards model with Breslow method to control for ties, stratification factors SoC therapy, and histology in strata statement, and CI is calculated using profile likelihood approach.|As part of the contribution of components analysis for sub-study B, durvalumab plus tremelimumab treatment arm was compared with durvalumab monotherapy.||1.12|0.68|0.282
72416413|NCT02352948|144343485|SUPERIORITY||Hazard Ratio (HR)|0.67||||0.011|TWO_SIDED|95.0|0.49|0.92|||Log Rank|The P-value arises from a stratified log-rank test adjusting for SoC therapy and histology, with ties handled by the Breslow approach.|Hazard ratio and CI are estimated from a stratified Cox proportional hazards model with Breslow method to control for ties, stratification factors SoC therapy, and histology in strata statement, and CI is calculated using profile likelihood approach.|As part of the contribution of components analysis for sub-study B, durvalumab plus tremelimumab treatment arm was compared with tremelimumab monotherapy.||0.92|0.49|0.011
72416414|NCT02352948|144343486|OTHER|Sub-study A was not powered and thus no formal statistical comparisons were performed.|Odds Ratio (OR)|3.87|||||TWO_SIDED|95.0|1.61|10.1|||||The analysis was performed using logistic regression adjusting for SoC therapy (gemcitabine/vinorelbine versus erlotinib) and histology (squamous versus all other histology types), with 95% CI calculated by profile likelihood.|For sub-study A: durvalumab monotherapy treatment arm was compared with SoC.||10.10|1.61|
72416415|NCT02352948|144343486|SUPERIORITY||Odds Ratio (OR)|2.43||||0.037|TWO_SIDED|95.0|1.1|5.94|||Regression, Logistic||The analysis was performed using logistic regression adjusting for SoC therapy (gemcitabine/vinorelbine versus erlotinib) and histology (squamous versus all other histology types), with 95% CI calculated by profile likelihood.|For sub-study B: durvalumab plus tremelimumab treatment arm was compared with SoC.||5.94|1.10|0.037
72416416|NCT02352948|144343486|SUPERIORITY||Odds Ratio (OR)|0.97||||0.923|TWO_SIDED|95.0|0.51|1.89|||Regression, Logistic||The analysis was performed using logistic regression adjusting for SoC therapy (gemcitabine/vinorelbine versus erlotinib) and histology (squamous versus all other histology types), with 95% CI calculated by profile likelihood.|For sub-study B: durvalumab plus tremelimumab treatment arm was compared with durvalumab monotherapy.||1.89|0.51|0.923
72606162|NCT00676403|144740415|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|0.3||0.0675||95.0|-1.1|0.0|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.0|-1.1|0.0675
72606163|NCT00676403|144740415|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.3||0.225||95.0|-1.0|0.2|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.2|-1.0|0.2250
72606164|NCT00676403|144740415|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.31||0.3728||95.0|-0.9|0.3|||Mixed Models Analysis|||Week 3: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.3|-0.9|0.3728
72416417|NCT02352948|144343486|SUPERIORITY||Odds Ratio (OR)|2.46||||0.109|TWO_SIDED|95.0|0.91|8.61|||Regression, Logistic||The analysis was performed using logistic regression adjusting for SoC therapy (gemcitabine/vinorelbine versus erlotinib) and histology (squamous versus all other histology types), with 95% CI calculated by profile likelihood.|For sub-study B: durvalumab plus tremelimumab treatment arm was compared with tremelimumab monotherapy.||8.61|0.91|0.109
72416418|NCT02352948|144343490|SUPERIORITY||Hazard Ratio (HR)|0.65||||0.002|TWO_SIDED|95.0|0.49|0.85|||Log Rank|The P-value arises from a stratified log-rank test adjusting for SoC therapy and histology, with ties handled by the Breslow approach.|Hazard ratio and CI are estimated from a stratified Cox proportional hazards model with Breslow method to control for ties, stratification factors SoC therapy, and histology in strata statement, and CI is calculated using profile likelihood approach.|For sub-study B: durvalumab plus tremelimumab treatment arm was compared with SoC.||0.85|0.49|0.002
72416419|NCT00234065|144343501|NON_INFERIORITY_OR_EQUIVALENCE|If the upper 95% CI limit for the HR of cilostazol to aspirin was 1.33 (4/3) or lower , cilostazol would be non-inferior to aspirin.|Hazard Ratio, log|0.743||||0.0357|TWO_SIDED|95.0|0.564|0.981||The log-rank test was used to verify the superiority of CLZ to ASA only if non-inferiority was verified. The adjusted significance level for the superiority test of the endpoint was set at 0.0471 (two-tailed) according to the O'Brien-Fleming method.|Log Rank|||Statistical Analysis 1 for Number of Patients With First Occurrence of Stroke||0.981|0.564|0.0357
72416420|NCT00234065|144343502|SUPERIORITY_OR_OTHER||Hazard Ratio, log|0.88||||0.4189|TWO_SIDED|95.0|0.645|1.2|||Log Rank|||Analyses were done using the full analysis set (FAS) of patients, as predetermined in the protocol. The full analysis set excluded patients who failed to satisfy inclusion criteria and those who violated exclusion criteria.||1.200|0.645|0.4189
72416421|NCT00234065|144343503|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.898||||0.4582|TWO_SIDED|95.0|0.675|1.194|||Log Rank|||Analyses were done using the full analysis set (FAS) of patients, as predetermined in the protocol. The full analysis set excluded patients who failed to satisfy inclusion criteria and those who violated exclusion criteria.||1.194|0.675|0.4582
72416422|NCT00234065|144343504|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.072||||0.86|TWO_SIDED|95.0|0.497|2.313|||Log Rank|||Analyses were done using the full analysis set (FAS) of patients, as predetermined in the protocol. The full analysis set excluded patients who failed to satisfy inclusion criteria and those who violated exclusion criteria.||2.313|0.497|0.8600
72416423|NCT00234065|144343505|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.799||||0.0437|TWO_SIDED|95.0|0.643|0.994|||Log Rank|||Analyses were done using the full analysis set (FAS) of patients, as predetermined in the protocol. The full analysis set excluded patients who failed to satisfy inclusion criteria and those who violated exclusion criteria.||0.994|0.643|0.0437
72606165|NCT00676403|144740415|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.3||0.2686||95.0|-0.9|0.3|||Mixed Models Analysis|||Week 3: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.3|-0.9|0.2686
72606166|NCT00676403|144740415|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.31||0.0753||95.0|-1.2|0.1|||Mixed Models Analysis|||Week 3: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.1|-1.2|0.0753
72606167|NCT00676403|144740415|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|0.3||0.1335||95.0|-1.0|0.1|||Mixed Models Analysis|||Week 3: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.1|-1.0|0.1335
72416424|NCT00234065|144343506|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.458||||0.0004|TWO_SIDED|95.0|0.296|0.711|||Log Rank|||Analyses were done using the full analysis set (FAS) of patients, as predetermined in the protocol. The full analysis set excluded patients who failed to satisfy inclusion criteria and those who violated exclusion criteria.||0.711|0.296|0.0004
72416425|NCT00126438|144343507|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.36||||0.001|TWO_SIDED|95.0|0.18|0.73||At 0.025 level of significance.|Cox Proportional Hazards Model|||"Analysis based on Reader A readings. Data analysis to assess the relative hazard of an adverse cardiac event was performed using a Cox proportional hazards model. Hazard (risk) of an event for a participant with low H/M at time t was expressed as Hl (t)/ Hh (t) = Ψ, where Hl (t) and Hh (t) denote the hazard of an event at time t for participants with low H/M and high H/M respectively."||0.73|0.18|0.001
72416426|NCT00126438|144343507|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.36||||0.001|TWO_SIDED|95.0|0.18|0.72||At 0.025 level of significance.|Cox Proportional Hazards Model|||"Analysis based on Reader B readings. Data analysis to assess the relative hazard of an adverse cardiac event was performed using a Cox proportional hazards model. Hazard (risk) of an event for a participant with low H/M at time t was expressed as Hl (t)/ Hh (t) = Ψ, where Hl (t) and Hh (t) denote the hazard of an event at time t for participants with low H/M and high H/M respectively."||0.72|0.18|0.001
72606168|NCT00676403|144740415|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|0.31||0.022||95.0|-1.3|-0.1|||Mixed Models Analysis|||Week 3: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||-0.1|-1.3|0.0220
72606169|NCT00676403|144740415|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.31||0.5754||95.0|-0.8|0.4|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.4|-0.8|0.5754
72416427|NCT00126438|144343507|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.35||||0.001|TWO_SIDED|95.0|0.17|0.72||At 0.025 level of significance.|Cox Proportional Hazards Model|||"Analysis based on Reader C readings. Data analysis to assess the relative hazard of an adverse cardiac event was performed using a Cox proportional hazards model. Hazard (risk) of an event for a participant with low H/M at time t was expressed as Hl (t)/ Hh (t) = Ψ, where Hl (t) and Hh (t) denote the hazard of an event at time t for participants with low H/M and high H/M respectively."||0.72|0.17|0.001
72416428|NCT05520138|144343510|SUPERIORITY|With a 2-sided Type I of 0.05 significance.|Hazard Ratio (HR)|1.1|||||TWO_SIDED|95.0|1.04|1.16|||||A weighted Cox proportional hazard model with an independent variable for treatment group were fitted, using a robust variance estimator.|||1.16|1.04|
72416429|NCT05520138|144343511|SUPERIORITY|With a 2-sided Type I of 0.05 significance.|Hazard Ratio (HR)|1.16|||||TWO_SIDED|95.0|1.06|1.27|||||A weighted Cox proportional hazard model with an independent variable for treatment group were fitted, using a robust variance estimator.|||1.27|1.06|
72606170|NCT00676403|144740415|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.3||0.348||95.0|-0.9|0.3|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.3|-0.9|0.3480
72606171|NCT00676403|144740415|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.31||0.0554||95.0|-1.2|0.0|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.0|-1.2|0.0554
72606172|NCT00676403|144740415|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.3||0.4362||95.0|-0.8|0.4|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.4|-0.8|0.4362
72606173|NCT00676403|144740415|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.3||0.3631||95.0|-0.9|0.3|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.3|-0.9|0.3631
72606174|NCT00676403|144740415|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|0.31||0.1152||95.0|-1.1|0.1|||Mixed Models Analysis|||Week 5: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.1|-1.1|0.1152
72606175|NCT00676403|144740415|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.3||0.4741||95.0|-0.8|0.4|||Mixed Models Analysis|||Week 5: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.4|-0.8|0.4741
72606176|NCT00676403|144740415|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.8|STANDARD_ERROR_OF_MEAN|0.31||0.0091||95.0|-1.4|-0.2|||Mixed Models Analysis|||Week 5: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||-0.2|-1.4|0.0091
72606177|NCT00676403|144740415|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.3||0.1721||95.0|-1.0|0.2|||Mixed Models Analysis|||Week 5: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.2|-1.0|0.1721
72606178|NCT00676403|144740415|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|0.31||0.0262||95.0|-1.3|-0.1|||Mixed Models Analysis|||Week 5: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||-0.1|-1.3|0.0262
72606179|NCT00676403|144740415|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.31||0.9505||95.0|-0.6|0.6|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.6|-0.6|0.9505
72416430|NCT05520138|144343512|OTHER||Hazard Ratio (HR)|1.04|||||TWO_SIDED|95.0|0.99|1.1|||||A weighted Cox proportional hazard model with an independent variable for treatment group were fitted, using a robust variance estimator.|||1.10|0.99|
72416431|NCT05520138|144343513|OTHER||Hazard Ratio (HR)|1.14|||||TWO_SIDED|95.0|1.06|1.22|||||A weighted Cox proportional hazard model with an independent variable for treatment group were fitted, using a robust variance estimator.|||1.22|1.06|
72416432|NCT00240487|144343522|NON_INFERIORITY_OR_EQUIVALENCE|The primary outcome variable is the mean PaO2/FiO2 in each group after 8 hours of study participation to determine whether timing of treatment with nitric oxide impacts outcome (immediate treatment versus delayed treatment).|||||>|0.05|TWO_SIDED||||||t-test, 2 sided|||Differences in mean PaO2/FiO2 ratios between the two groups will help to determine whether order of therapy (immediate treatment with nitric oxide versus delayed treatment with nitric oxide) impacts outcomes.||||>0.05
72416433|NCT01106833|144343527|SUPERIORITY|||||||0.63||||||Two-sided testing was performed using a significance level of 0.05|Fisher Exact|||The null hypothesis is that the proportion of participants with treatment success at 6 months is equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.||||0.63
72416434|NCT01106833|144343527|SUPERIORITY|||||||0.44||||||Two-sided testing was performed using a significance level of 0.05|Fisher Exact|||The null hypothesis is that the proportion of participants with treatment success at 24 months is equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.||||0.44
72416435|NCT01106833|144343528|SUPERIORITY|||||||0.205||||||Two-sided testing was performed using a significance level of 0.05|Log Rank|||The null hypothesis is that the rate of overall survival during the first two years post-randomization is equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.||||0.205
72606180|NCT00676403|144740415|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.3||0.6877||95.0|-0.7|0.5|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.5|-0.7|0.6877
72606181|NCT00676403|144740415|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|0.31||0.1271||95.0|-1.1|0.1|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.1|-1.1|0.1271
72606182|NCT00676403|144740415|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.3||0.9136||95.0|-0.6|0.6|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.6|-0.6|0.9136
72606183|NCT00676403|144740415|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.31||0.4072||95.0|-0.9|0.3|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.3|-0.9|0.4072
72606184|NCT00676403|144740416|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-14.2|STANDARD_ERROR_OF_MEAN|10.68||0.186||95.0|-35.2|6.9|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||6.9|-35.2|0.1860
72606185|NCT00676403|144740416|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.7|STANDARD_ERROR_OF_MEAN|10.54||0.653||95.0|-25.5|16.0|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||16.0|-25.5|0.6530
72606186|NCT00676403|144740416|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.3|STANDARD_ERROR_OF_MEAN|10.79||0.6263||95.0|-26.5|16.0|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||16.0|-26.5|0.6263
72606187|NCT00676403|144740416|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-8.5|STANDARD_ERROR_OF_MEAN|10.63||0.4266||95.0|-29.4|12.5|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||12.5|-29.4|0.4266
72606188|NCT00676403|144740416|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-8.8|STANDARD_ERROR_OF_MEAN|10.54||0.4023||95.0|-29.6|11.9|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||11.9|-29.6|0.4023
72416436|NCT01106833|144343529|SUPERIORITY|||||||0.141||||||Two-sided testing was performed using a significance level of 0.05|Log Rank|||The null hypothesis is that the rate of progression-free survival during the first two years post-randomization is equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.||||0.141
72416437|NCT01106833|144343530|SUPERIORITY|||||||0.775||||||Two-sided testing was performed using a significance level of 0.05|Log Rank|||The null hypothesis is that the rate of failure-free survival during the first two years post-randomization is equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.||||0.775
72416438|NCT01106833|144343531|SUPERIORITY|||||||0.396||||||Two-sided testing was performed using a significance level of 0.05|Gray's test|Death without relapse was treated as a competing risk||The null hypothesis is that the rate of relapse during the first two years post-randomization is equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.||||0.396
72416439|NCT01106833|144343532|SUPERIORITY|||||||0.219||||||Two-sided testing was performed using a significance level of 0.05|Gray's test|Death without initiation of secondary therapy is considered a competing risk for this endpoint||The null hypothesis is that the rate of initiation of secondary immunosuppressive therapy for chronic GVHD during the first two years post-randomization is equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.||||0.219
72416440|NCT01106833|144343533|SUPERIORITY|||||||0.706||||||Two-sided testing was performed using a significance level of 0.05|Gray's test|Death without discontinuation of systemic immunosuppressive therapy is considered a competing risk for this endpoint||The null hypothesis is that the rate of discontinuation of systemic immunosuppressive therapy during the first two years post-randomization is equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.||||0.706
72416441|NCT01106833|144343534|SUPERIORITY|||||||0.127||||||Two-sided testing was performed using a significance level of 0.05|Kruskal-Wallis|||The null hypothesis is that the median prednisone dose at baseline is equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.||||0.127
72416442|NCT01106833|144343534|SUPERIORITY|||||||0.562||||||Two-sided testing was performed using a significance level of 0.05|Kruskal-Wallis|||The null hypothesis is that the median prednisone dose at 6 months post-randomization is equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.||||0.562
72416443|NCT01106833|144343534|SUPERIORITY|||||||0.129||||||Two-sided testing was performed using a significance level of 0.05|Kruskal-Wallis|||The null hypothesis is that the median prednisone dose at 1 year post-randomization is equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.||||0.129
72416444|NCT01106833|144343535|SUPERIORITY|||||||0.586||||||Two-sided testing was performed using a significance level of 0.05|Kruskal-Wallis|||The null hypothesis is that the median change in prednisone dose from baseline to 6 months post-randomization is equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.||||0.586
72606189|NCT00676403|144740416|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-17.6|STANDARD_ERROR_OF_MEAN|10.77||0.1041||95.0|-38.8|3.6|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||3.6|-38.8|0.1041
72606190|NCT00676403|144740416|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-7.0|STANDARD_ERROR_OF_MEAN|10.6||0.5084||95.0|-27.9|13.8|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||13.8|-27.9|0.5084
72606191|NCT00676403|144740416|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-12.5|STANDARD_ERROR_OF_MEAN|11.1||0.262||95.0|-34.3|9.4|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||9.4|-34.3|0.2620
72606192|NCT00676403|144740416|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-10.3|STANDARD_ERROR_OF_MEAN|10.7||0.3347||95.0|-31.4|10.7|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||10.7|-31.4|0.3347
72606193|NCT00676403|144740416|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-16.8|STANDARD_ERROR_OF_MEAN|10.61||0.1142||95.0|-37.7|4.1|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||4.1|-37.7|0.1142
72606194|NCT00676403|144740416|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-17.1|STANDARD_ERROR_OF_MEAN|11.06||0.1237||95.0|-38.8|4.7|||Mixed Models Analysis|||Week 3: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||4.7|-38.8|0.1237
72416445|NCT01106833|144343535|SUPERIORITY|||||||0.14||||||Two-sided testing was performed using a significance level of 0.05|Kruskal-Wallis|||The null hypothesis is that the median change in prednisone dose from baseline to 1 year post-randomization is equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.||||0.140
72416446|NCT01106833|144343536|SUPERIORITY|||||||0.582||||||Two-sided testing was performed using a significance level of 0.05|Kruskal-Wallis|||The null hypothesis is that the median serum creatinine level at baseline is equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.||||0.582
72416447|NCT01106833|144343536|SUPERIORITY|||||||0.208||||||Two-sided testing was performed using a significance level of 0.05|Kruskal-Wallis|||The null hypothesis is that the median serum creatinine level at 6 months post-randomization is equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.||||0.208
72416448|NCT01106833|144343536|SUPERIORITY|||||||0.431||||||Two-sided testing was performed using a significance level of 0.05|Kruskal-Wallis|||The null hypothesis is that the median serum creatinine level at 1 year post-randomization is equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.||||0.431
72416449|NCT01106833|144343537|SUPERIORITY|||||||0.147||||||Two-sided testing was performed using a significance level of 0.05|Kruskal-Wallis|||The null hypothesis is that the median change in serum creatinine level from baseline to 6 months post-randomization is equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.||||0.147
72606195|NCT00676403|144740416|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.3|STANDARD_ERROR_OF_MEAN|10.67||0.8302||95.0|-18.7|23.3|||Mixed Models Analysis|||Week 3: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||23.3|-18.7|0.8302
72606196|NCT00676403|144740416|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-11.6|STANDARD_ERROR_OF_MEAN|11.22||0.3039||95.0|-33.6|10.5|||Mixed Models Analysis|||Week 3: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||10.5|-33.6|0.3039
72606197|NCT00676403|144740416|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-8.0|STANDARD_ERROR_OF_MEAN|10.77||0.4595||95.0|-29.2|13.2|||Mixed Models Analysis|||Week 3: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||13.2|-29.2|0.4595
72606198|NCT00676403|144740416|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-8.6|STANDARD_ERROR_OF_MEAN|10.97||0.4338||95.0|-30.2|13.0|||Mixed Models Analysis|||Week 3: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||13.0|-30.2|0.4338
72606199|NCT00676403|144740416|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-20.4|STANDARD_ERROR_OF_MEAN|10.99||0.0647||95.0|-42.0|1.2|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||1.2|-42.0|0.0647
72606200|NCT00676403|144740416|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.1|STANDARD_ERROR_OF_MEAN|10.61||0.5651||95.0|-27.0|14.8|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||14.8|-27.0|0.5651
72606201|NCT00676403|144740416|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-15.6|STANDARD_ERROR_OF_MEAN|11.16||0.1634||95.0|-37.6|6.4|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||6.4|-37.6|0.1634
72606202|NCT00676403|144740416|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-13.2|STANDARD_ERROR_OF_MEAN|10.77||0.2209||95.0|-34.4|8.0|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||8.0|-34.4|0.2209
72416450|NCT01106833|144343537|SUPERIORITY|||||||0.863||||||Two-sided testing was performed using a significance level of 0.05|Kruskal-Wallis|||The null hypothesis is that the median change in serum creatinine level from baseline to 1 year post-randomization is equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.||||0.863
72606203|NCT00676403|144740416|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-16.5|STANDARD_ERROR_OF_MEAN|10.84||0.1293||95.0|-37.8|4.8|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||4.8|-37.8|0.1293
72606204|NCT00676403|144740416|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-26.8|STANDARD_ERROR_OF_MEAN|11.06||0.0161||95.0|-48.5|-5.0|||Mixed Models Analysis|||Week 5: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||-5.0|-48.5|0.0161
72606205|NCT00676403|144740416|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.0|STANDARD_ERROR_OF_MEAN|10.67||0.8506||95.0|-23.0|19.0|||Mixed Models Analysis|||Week 5: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||19.0|-23.0|0.8506
72416451|NCT01106833|144343538|SUPERIORITY|||||||0.62||||||Two-sided testing was performed using a significance level of 0.05|Fisher Exact|||The null hypothesis is that the proportions of patients in the patient-reported severity and vital status categories considered at baseline are equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.||||0.620
72416452|NCT01106833|144343538|SUPERIORITY|||||||0.258||||||Two-sided testing was performed using a significance level of 0.05|Fisher Exact|||The null hypothesis is that the proportions of patients in the patient-reported severity and vital status categories considered at 6 months post-randomization are equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.||||0.258
72416453|NCT01106833|144343538|SUPERIORITY|||||||0.036||||||Two-sided testing was performed using a significance level of 0.05|Fisher Exact|||The null hypothesis is that the proportions of patients in the patient-reported severity and vital status categories considered at 1 year post-randomization are equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.||||0.036
72416454|NCT01106833|144343538|SUPERIORITY|||||||0.369||||||Two-sided testing was performed using a significance level of 0.05|Fisher Exact|||The null hypothesis is that the proportions of patients in the patient-reported severity and vital status categories considered at 2 years post-randomization are equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.||||0.369
72416455|NCT01106833|144343539|SUPERIORITY|||||||0.45||||||Two-sided testing was performed using a significance level of 0.05|Fisher Exact|||The null hypothesis is that the proportions of patients in the provider-reported severity and vital status categories considered at baseline are equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.||||0.450
72416456|NCT01106833|144343539|SUPERIORITY|||||||0.301||||||Two-sided testing was performed using a significance level of 0.05|Fisher Exact|||The null hypothesis is that the proportions of patients in the provider-reported severity and vital status categories considered at 6 months post-randomization are equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.||||0.301
72416457|NCT01106833|144343539|SUPERIORITY|||||||0.75||||||Two-sided testing was performed using a significance level of 0.05|Fisher Exact|||The null hypothesis is that the proportions of patients in the provider-reported severity and vital status categories considered at 1 year post-randomization are equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.||||0.750
72416458|NCT01106833|144343539|SUPERIORITY|||||||0.444||||||Two-sided testing was performed using a significance level of 0.05|Fisher Exact|||The null hypothesis is that the proportions of patients in the provider-reported severity and vital status categories considered at 2 years post-randomization are equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.||||0.444
72416459|NCT01106833|144343540|SUPERIORITY|||||||0.238||||||Two-sided testing was performed using a significance level of 0.05|Fisher Exact|||The null hypothesis is that the proportions of patients in the NIH Consensus Criteria severity and vital status categories considered at baseline are equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.||||0.238
72606206|NCT00676403|144740416|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-30.9|STANDARD_ERROR_OF_MEAN|11.31||0.0067||95.0|-53.2|-8.6|||Mixed Models Analysis|||Week 5: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||-8.6|-53.2|0.0067
72416460|NCT01106833|144343540|SUPERIORITY|||||||0.546||||||Two-sided testing was performed using a significance level of 0.05|Fisher Exact|||The null hypothesis is that the proportions of patients in the NIH Consensus Criteria severity and vital status categories considered at 6 months post-randomization are equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.||||0.546
72606207|NCT00676403|144740416|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-13.8|STANDARD_ERROR_OF_MEAN|10.76||0.1997||95.0|-35.0|7.4|||Mixed Models Analysis|||Week 5: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||7.4|-35.0|0.1997
72416461|NCT01106833|144343540|SUPERIORITY|||||||0.756||||||Two-sided testing was performed using a significance level of 0.05|Fisher Exact|||The null hypothesis is that the proportions of patients in the NIH Consensus Criteria severity and vital status categories considered at 1 year post-randomization are equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.||||0.756
72416462|NCT01106833|144343540|SUPERIORITY|||||||0.554||||||Two-sided testing was performed using a significance level of 0.05|Fisher Exact|||The null hypothesis is that the proportions of patients in the NIH Consensus Criteria severity and vital status categories considered at 2 years post-randomization are equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.||||0.554
72416463|NCT01106833|144343541|SUPERIORITY|||||||0.685||||||Two-sided testing was performed using a significance level of 0.05|t-test, 2 sided|Independent samples t-test||The null hypothesis is that the mean PCS scores at baseline are equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.||||0.685
72416464|NCT01106833|144343541|SUPERIORITY|||||||0.105||||||Two-sided testing was performed using a significance level of 0.05|t-test, 2 sided|Independent samples t-test||The null hypothesis is that the mean PCS scores at 2 months are equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.||||0.105
72606208|NCT00676403|144740416|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-26.4|STANDARD_ERROR_OF_MEAN|10.9||0.0159||95.0|-47.9|-5.0|||Mixed Models Analysis|||Week 5: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||-5.0|-47.9|0.0159
72606209|NCT00676403|144740416|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-22.8|STANDARD_ERROR_OF_MEAN|10.98||0.0388||95.0|-44.4|-1.2|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||-1.2|-44.4|0.0388
72606210|NCT00676403|144740416|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|10.73||0.9962||95.0|-21.2|21.1|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||21.1|-21.2|0.9962
72416465|NCT01106833|144343541|SUPERIORITY|||||||0.039||||||Two-sided testing was performed using a significance level of 0.05|t-test, 2 sided|Independent samples t-test||The null hypothesis is that the mean PCS scores at 6 months are equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.||||0.039
72606211|NCT00676403|144740416|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-19.8|STANDARD_ERROR_OF_MEAN|11.41||0.0839||95.0|-42.3|2.7|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||2.7|-42.3|0.0839
72606212|NCT00676403|144740416|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.9|STANDARD_ERROR_OF_MEAN|10.83||0.5216||95.0|-28.3|14.4|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||14.4|-28.3|0.5216
72606213|NCT00676403|144740416|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-21.3|STANDARD_ERROR_OF_MEAN|10.98||0.0534||95.0|-42.9|0.3|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.3|-42.9|0.0534
72606214|NCT00676403|144740417|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|13.8|STANDARD_ERROR_OF_MEAN|5.89||0.0199||95.0|2.2|25.4|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||25.4|2.2|0.0199
72606215|NCT00676403|144740417|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|10.3|STANDARD_ERROR_OF_MEAN|5.78||0.0768||95.0|-1.1|21.7|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||21.7|-1.1|0.0768
72606216|NCT00676403|144740417|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|11.0|STANDARD_ERROR_OF_MEAN|5.91||0.0642||95.0|-0.7|22.6|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||22.6|-0.7|0.0642
72606217|NCT00676403|144740417|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|6.6|STANDARD_ERROR_OF_MEAN|5.88||0.2643||95.0|-5.0|18.2|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||18.2|-5.0|0.2643
72606218|NCT00676403|144740417|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|12.2|STANDARD_ERROR_OF_MEAN|5.8||0.0358||95.0|0.8|23.7|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||23.7|0.8|0.0358
72606219|NCT00676403|144740417|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|12.1|STANDARD_ERROR_OF_MEAN|5.93||0.0428||95.0|0.4|23.8|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||23.8|0.4|0.0428
72606220|NCT00676403|144740417|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|7.5|STANDARD_ERROR_OF_MEAN|5.81||0.1993||95.0|-4.0|18.9|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||18.9|-4.0|0.1993
72606221|NCT00676403|144740417|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|12.9|STANDARD_ERROR_OF_MEAN|6.04||0.0331||95.0|1.1|24.8|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||24.8|1.1|0.0331
72416466|NCT01106833|144343541|SUPERIORITY|||||||0.278||||||Two-sided testing was performed using a significance level of 0.05|t-test, 2 sided|Independent samples t-test||The null hypothesis is that the mean PCS scores at 1 year are equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.||||0.278
72416467|NCT01106833|144343541|SUPERIORITY|||||||0.804||||||Two-sided testing was performed using a significance level of 0.05|t-test, 2 sided|Independent samples t-test||The null hypothesis is that the mean PCS scores at 2 years are equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.||||0.804
72416468|NCT01106833|144343542|SUPERIORITY|||||||0.631||||||Two-sided testing was performed using a significance level of 0.05|t-test, 2 sided|Independent samples t-test||The null hypothesis is that the mean MCS scores at baseline are equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.||||0.631
72416469|NCT01106833|144343542|SUPERIORITY|||||||0.759||||||Two-sided testing was performed using a significance level of 0.05|t-test, 2 sided|Independent samples t-test||The null hypothesis is that the mean MCS scores at 2 months are equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.||||0.759
72606222|NCT00676403|144740417|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|12.1|STANDARD_ERROR_OF_MEAN|5.91||0.0415||95.0|0.5|23.8|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||23.8|0.5|0.0415
72416470|NCT01106833|144343542|SUPERIORITY|||||||0.391||||||Two-sided testing was performed using a significance level of 0.05|t-test, 2 sided|Independent samples t-test||The null hypothesis is that the mean MCS scores at 6 months are equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.||||0.391
72606223|NCT00676403|144740417|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|12.8|STANDARD_ERROR_OF_MEAN|5.83||0.0295||95.0|1.3|24.3|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||24.3|1.3|0.0295
72606224|NCT00676403|144740417|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|9.2|STANDARD_ERROR_OF_MEAN|6.01||0.1267||95.0|-2.6|21.1|||Mixed Models Analysis|||Week 3: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||21.1|-2.6|0.1267
72606225|NCT00676403|144740417|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.7|STANDARD_ERROR_OF_MEAN|5.84||0.4175||95.0|-6.8|16.2|||Mixed Models Analysis|||Week 3: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||16.2|-6.8|0.4175
72606226|NCT00676403|144740417|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|13.0|STANDARD_ERROR_OF_MEAN|6.09||0.0342||95.0|1.0|25.0|||Mixed Models Analysis|||Week 3: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||25.0|1.0|0.0342
72416471|NCT01106833|144343542|SUPERIORITY|||||||0.222||||||Two-sided testing was performed using a significance level of 0.05|t-test, 2 sided|Independent samples t-test||The null hypothesis is that the mean MCS scores at 1 year are equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.||||0.222
72416472|NCT01106833|144343542|SUPERIORITY|||||||0.527||||||Two-sided testing was performed using a significance level of 0.05|t-test, 2 sided|Independent samples t-test||The null hypothesis is that the mean MCS scores at 2 years are equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.||||0.527
72606227|NCT00676403|144740417|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|9.7|STANDARD_ERROR_OF_MEAN|5.96||0.1038||95.0|-2.0|21.5|||Mixed Models Analysis|||Week 3: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||21.5|-2.0|0.1038
72606228|NCT00676403|144740417|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|11.6|STANDARD_ERROR_OF_MEAN|5.98||0.0537||95.0|-0.2|23.4|||Mixed Models Analysis|||Week 3: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||23.4|-0.2|0.0537
72606229|NCT00676403|144740417|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|10.6|STANDARD_ERROR_OF_MEAN|5.99||0.0772||95.0|-1.2|22.4|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||22.4|-1.2|0.0772
72416473|NCT01106833|144343543|SUPERIORITY|||||||0.763||||||Two-sided testing was performed using a significance level of 0.05|t-test, 2 sided|Independent samples t-test||The null hypothesis is that the mean FACT-BMT scores at baseline are equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.||||0.763
72416474|NCT01106833|144343543|SUPERIORITY|||||||0.133||||||Two-sided testing was performed using a significance level of 0.05|t-test, 2 sided|Independent samples t-test||The null hypothesis is that the mean FACT-BMT scores at 2 months are equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.||||0.133
72416475|NCT01106833|144343543|SUPERIORITY|||||||0.953||||||Two-sided testing was performed using a significance level of 0.05|t-test, 2 sided|Independent samples t-test||The null hypothesis is that the mean FACT-BMT scores at 6 months are equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.||||0.953
72416476|NCT01106833|144343543|SUPERIORITY|||||||0.398||||||Two-sided testing was performed using a significance level of 0.05|t-test, 2 sided|Independent samples t-test||The null hypothesis is that the mean FACT-BMT scores at 1 year are equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.||||0.398
72416477|NCT01106833|144343543|SUPERIORITY|||||||0.309||||||Two-sided testing was performed using a significance level of 0.05|t-test, 2 sided|Independent samples t-test||The null hypothesis is that the mean FACT-BMT scores at 2 years are equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.||||0.309
72416478|NCT00886340|144343545|SUPERIORITY_OR_OTHER|||||||0.08||95.0||||controlled for site, income, race/ethnicity|Mixed Models Analysis|||pilot test, used 20% of sample required for a full test of the hypothesis||||0.08
72416479|NCT02120027|144343602|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.986||||0.949|TWO_SIDED|95.0|0.64|1.53|||Cochran-Mantel-Haenszel|||||1.53|0.64|0.949
72416480|NCT02120027|144343603|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.28||||0.193|TWO_SIDED|95.0|0.88|1.86|||Cochran-Mantel-Haenszel|||||1.86|0.88|0.193
72416481|NCT02120027|144343604|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.032||||0.872|TWO_SIDED|95.0|0.7|1.53|||Cochran-Mantel-Haenszel|||||1.53|0.70|0.872
72416482|NCT02120027|144343605|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.339||||0.272|TWO_SIDED|95.0|0.79|2.26|||Cochran-Mantel-Haenszel|||||2.26|0.79|0.272
72416483|NCT02120027|144343606|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.153||||0.567|TWO_SIDED|95.0|0.73|1.81|||Cochran-Mantel-Haenszel|||||1.81|0.73|0.567
72416484|NCT01002872|144343607|SUPERIORITY|||||||0.037|||||||t-test, 2 sided|||||||0.037
72416485|NCT01002872|144343608|SUPERIORITY|||||||0.721|||||||t-test, 2 sided|||||||0.721
72416486|NCT01002872|144343609|SUPERIORITY|||||||0.897|||||||t-test, 2 sided|||||||0.897
72416487|NCT01002872|144343610|SUPERIORITY|||||||0.743|||||||t-test, 2 sided|||||||0.743
72416488|NCT01002872|144343611|SUPERIORITY|||||||0.416|||||||t-test, 2 sided|||||||0.416
72416489|NCT01002872|144343612|SUPERIORITY|||||||0.672|||||||t-test, 2 sided|||||||0.672
72416490|NCT01002872|144343613|SUPERIORITY|||||||0.955|||||||t-test, 2 sided|||||||0.955
72416491|NCT01002872|144343614|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
72416492|NCT01002872|144343615|SUPERIORITY|||||||0.0066|||||||t-test, 2 sided|||||||0.0066
72416493|NCT00414817|144343616|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.018||||0.002|TWO_SIDED|95.0|0.006|0.03|||Regression, Linear|2-tailed p-value based on linear regression adjusted for site, age, sex, co-morbid COPD, baseline use of short acting beta agonists, and baseline mMPR|Estimated adherence was approximately 2 percentage points higher for intervention group than for usual care group.|In all of our analyses we used duration of follow-up as a weighting variable to reflect the fact that our adherence measure becomes more accurate and reliable with longer follow-up. This weighting is reflected both in the formal statistical analyses and in the presentation of means and standard deviations given above. Also, sensitivity analyses that included daily oral steroid users and those with fewer than 3 months of follow-up yielded similar results to those presented here.||.030|.006|.002
72416494|NCT00414817|144343617|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.175|TWO_SIDED|95.0|-0.23|0.04|||Regression, Linear|2-tailed p-value adjusted for site, age, sex, co-morbid COPD, baseline use of short acting beta agonists, and baseline adherence.||In all of our analyses we used duration of follow-up as a weighting variable. This weighting is reflected both in the formal statistical analyses and in the presentation of means and standard deviations given above.||0.04|-0.23|0.175
72416495|NCT00414817|144343618|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.0||||0.852|TWO_SIDED|95.0|0.96|1.06||2-tailed p-value based on overdispersed Poisson regression adjusted for site, age, sex, co-morbid COPD, baseline use of short acting beta agonists, and baseline mMPR|overdispersed Poisson regression|||In all of our analyses we used duration of follow-up as a weighting variable. This weighting is reflected both in the formal statistical analyses and in the presentation of means and standard deviations given above.||1.06|0.96|0.852
72416496|NCT00447057|144343619|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.63||||0.0047|TWO_SIDED|95.0|0.438|0.897|||Log Rank|Log-rank test with 1-sided alpha of 0.20||||0.897|0.438|0.0047
72416497|NCT00447057|144343620|SUPERIORITY_OR_OTHER|||||||0.3909|||||||Fisher Exact|||||||0.3909
72416498|NCT00447057|144343621|SUPERIORITY_OR_OTHER|||||||0.1808|||||||Fisher Exact|||||||0.1808
72416499|NCT00447057|144343622|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.64||||0.0034|TWO_SIDED|95.0|0.457|0.887||1-sided significance level of 0.20|Log Rank|||||0.887|0.457|0.0034
72416500|NCT00447057|144343623|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.68||||0.019|TWO_SIDED|95.0|0.465|0.981||1-sided significance level of 0.20|Log Rank|||||0.981|0.465|0.0190
72416501|NCT04493216|144343640|OTHER||Differences in percentage of participant|-9.2|||||TWO_SIDED|95.0|-24.0|5.7|||||Differences in percentage of participant = Percentage of participant in GSK3640254 100 mg+ Placebo+ ABC/3TC or FTC/TAF - Percentage of participant in DTG+ABC/3TC or FTC/TAF|||5.7|-24.0|
72416502|NCT04493216|144343640|OTHER||Differences in percentage of participant|-1.0|||||TWO_SIDED|95.0|-13.5|11.6|||||Differences in percentage of participant = Percentage of participant in GSK3640254 150 mg+ ABC/3TC or FTC/TAF - Percentage of participant in DTG+ ABC/3TC or FTC/TAF|||11.6|-13.5|
72416503|NCT04493216|144343640|OTHER||Differences in percentage of participant|-15.5|||||TWO_SIDED|95.0|-31.2|0.3|||||Differences in percentage of participant = Percentage of participant in GSK3640254 200 mg+ Placebo+ ABC/3TC or FTC/TAF - Percentage of participant in DTG+ ABC/3TC or FTC/TAF|||0.3|-31.2|
72416504|NCT02314624|144343696|SUPERIORITY|||||||0.734||||||Analyses were performed on each subscale individually. This is the p-value for the Depression subscale.|Chi-squared|GEE Type III chi squared distribution with 3 degrees of freedom was used to examine between-condition change over time from baseline.||We used the Generalized Linear Model to examine the between-condition change over time on study outcomes. We computed the design effects due to this nested design to determine the extent to which the intraclass correlation due to clustering and size of the cluster affected the analyses. Design effects ranged up to 1.8. Because all were under 2.0, we did not adjust analyses to account for clustering effects.||||.734
72416505|NCT02314624|144343696|SUPERIORITY|||||||0.27||||||Analyses were performed on each subscale individually. This is the p-value for the Anxiety subscale.|Chi-squared|GEE Type III chi squared distribution with 3 degrees of freedom was used to examine between-condition change over time from baseline||We used a Generalized Linear Model to examine the between-condition change over time on study outcomes. We computed the design effects due to this nested design to determine the extent to which the intraclass correlation due to clustering and size of the cluster affected the analyses. Design effects ranged up to 1.8. Because all were under 2.0, we did not adjust analyses to account for clustering effects.||||.27
72606230|NCT00676403|144740417|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|8.8|STANDARD_ERROR_OF_MEAN|5.81||0.1296||95.0|-2.6|20.3|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||20.3|-2.6|0.1296
72416506|NCT02314624|144343696|SUPERIORITY|||||||0.75||||||Analyses were performed on each subscale individually. This is the p-value for the Stress subscale.|Chi-squared|GEE Type III chi squared distribution with 3 degrees of freedom was used to examine between-condition change over time from baseline||We used a Generalized Linear Model to examine the between-condition change over time on study outcomes. We computed the design effects due to this nested design to determine the extent to which the intraclass correlation due to clustering and size of the cluster affected the analyses. Design effects ranged up to 1.8. Because all were under 2.0, we did not adjust analyses to account for clustering effects.||||.75
72416507|NCT02314624|144343696|SUPERIORITY|||||||0.812||||||Analyses were performed on each subscale individually. This is the p-value for the Suicide subscale.|Chi-squared|GEE Type III chi squared distribution with 3 degrees of freedom was used to examine between-condition change over time from baseline.||We used the Generalized Linear Model to examine the between-condition change over time on study outcomes. We computed the design effects due to this nested design to determine the extent to which the intraclass correlation due to clustering and size of the cluster affected the analyses. Design effects ranged up to 1.8. Because all were under 2.0, we did not adjust analyses to account for clustering effects.||||.812
72416508|NCT02314624|144343697|SUPERIORITY|||||||0.036|||||||Chi-squared|GEE Type III chi squared distribution with 3 degrees of freedom was used to examine between-condition change over time from baseline.||We used the Generalized Linear Model to examine the between-condition change over time. We computed the design effects due to this nested design to determine the extent to which the intraclass correlation due to clustering and size of the cluster affected the analyses. Design effects ranged up to 1.8. Because all were under 2.0, we did not adjust analyses to account for clustering effects.||||.036
72416509|NCT02314624|144343698|SUPERIORITY|||||||0.664|||||||Chi-squared|GEE Type III chi squared distribution with 3 degrees of freedom was used to examine between-condition change over time from baseline||We used the Generalized Linear Model to examine the between-condition change over time on study outcomes. We computed the design effects due to this nested design to determine the extent to which the intraclass correlation due to clustering and size of the cluster affected the analyses. Design effects ranged up to 1.8. Because all were under 2.0, we did not adjust analyses to account for clustering effects.||||.664
72416510|NCT02314624|144343699|SUPERIORITY|||||||0.764|||||||Chi-squared|GEE Type III chi squared distribution with 3 degrees of freedom was used to examine between-condition change over time from baseline.||We used the Generalized Linear Model to examine the between-condition change over time on study outcomes. We computed the design effects due to this nested design to determine the extent to which the intraclass correlation due to clustering and size of the cluster affected the analyses. Design effects ranged up to 1.8. Because all were under 2.0, we did not adjust analyses to account for clustering effects.||||.764
72606231|NCT00676403|144740417|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|15.0|STANDARD_ERROR_OF_MEAN|6.06||0.014||95.0|3.1|27.0|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||27.0|3.1|0.0140
72606232|NCT00676403|144740417|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|11.0|STANDARD_ERROR_OF_MEAN|5.93||0.0642||95.0|-0.7|22.7|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||22.7|-0.7|0.0642
72606233|NCT00676403|144740417|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|10.7|STANDARD_ERROR_OF_MEAN|5.92||0.073||95.0|-1.0|22.3|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||22.3|-1.0|0.0730
72606234|NCT00676403|144740417|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|13.9|STANDARD_ERROR_OF_MEAN|6.01||0.0215||95.0|2.1|25.8|||Mixed Models Analysis|||Week 5: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||25.8|2.1|0.0215
72606235|NCT00676403|144740417|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.2|STANDARD_ERROR_OF_MEAN|5.84||0.3785||95.0|-6.4|16.7|||Mixed Models Analysis|||Week 5: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||16.7|-6.4|0.3785
72606236|NCT00676403|144740417|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|16.1|STANDARD_ERROR_OF_MEAN|6.12||0.0089||95.0|4.1|28.2|||Mixed Models Analysis|||Week 5: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||28.2|4.1|0.0089
72606237|NCT00676403|144740417|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|11.2|STANDARD_ERROR_OF_MEAN|5.96||0.0609||95.0|-0.5|23.0|||Mixed Models Analysis|||Week 5: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||23.0|-0.5|0.0609
72606238|NCT00676403|144740417|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|16.4|STANDARD_ERROR_OF_MEAN|5.95||0.0064||95.0|4.7|28.1|||Mixed Models Analysis|||Week 5: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||28.1|4.7|0.0064
72606239|NCT00676403|144740417|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|13.7|STANDARD_ERROR_OF_MEAN|6.01||0.0241||95.0|1.8|25.5|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||25.5|1.8|0.0241
72606240|NCT00676403|144740417|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|9.6|STANDARD_ERROR_OF_MEAN|5.86||0.1032||95.0|-2.0|21.1|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||21.1|-2.0|0.1032
72606241|NCT00676403|144740417|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|16.6|STANDARD_ERROR_OF_MEAN|6.16||0.0076||95.0|4.4|28.7|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||28.7|4.4|0.0076
72416511|NCT02314624|144343700|SUPERIORITY|||||||0.44|||||||Chi-squared|GEE Type III chi squared distribution with 3 degrees of freedom was used to examine between-condition change over time from baseline.||We used the Generalized Linear Model to examine the between-condition change over time on study outcomes. We computed the design effects due to this nested design to determine the extent to which the intraclass correlation due to clustering and size of the cluster affected the analyses. Design effects ranged up to 1.8. Because all were under 2.0, we did not adjust analyses to account for clustering effects.||||.440
72416512|NCT02314624|144343701|SUPERIORITY|||||||0.09|||||||Chi-squared|GEE Type III chi squared distribution with 2 degrees of freedom was used to examine between-condition change over time.||We used the Generalized Linear Model to examine the between-condition change over time on study outcomes. We computed the design effects due to this nested design to determine the extent to which the intraclass correlation due to clustering and size of the cluster affected the analyses. Design effects ranged up to 1.8. Because all were under 2.0, we did not adjust analyses to account for clustering effects.||||.09
72416513|NCT02314624|144343702|SUPERIORITY|||||||0.19|||||||Chi-squared|GEE Type III chi squared distribution with 2 degrees of freedom was used to examine between-condition change over time from baseline.||We used the Generalized Linear Model to examine the between-condition change over time on study outcomes. We computed the design effects due to this nested design to determine the extent to which the intraclass correlation due to clustering and size of the cluster affected the analyses. Design effects ranged up to 1.8. Because all were under 2.0, we did not adjust analyses to account for clustering effects.||||.19
72606242|NCT00676403|144740417|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|9.2|STANDARD_ERROR_OF_MEAN|5.96||0.1257||95.0|-2.6|20.9|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||20.9|-2.6|0.1257
72606243|NCT00676403|144740417|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|14.9|STANDARD_ERROR_OF_MEAN|5.95||0.0131||95.0|3.2|26.6|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||26.6|3.2|0.0131
72606244|NCT00676403|144740418|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-9.3|STANDARD_ERROR_OF_MEAN|6.94||0.1824||95.0|-23.0|4.4|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||4.4|-23.0|0.1824
72606245|NCT00676403|144740418|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-12.1|STANDARD_ERROR_OF_MEAN|6.8||0.0767||95.0|-25.5|1.3|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||1.3|-25.5|0.0767
72606246|NCT00676403|144740418|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-14.1|STANDARD_ERROR_OF_MEAN|7.11||0.0492||95.0|-28.1|-0.1|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||-0.1|-28.1|0.0492
72606247|NCT00676403|144740418|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-8.7|STANDARD_ERROR_OF_MEAN|6.84||0.2023||95.0|-22.2|4.7|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||4.7|-22.2|0.2023
72606248|NCT00676403|144740418|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-17.4|STANDARD_ERROR_OF_MEAN|6.83||0.0116||95.0|-30.9|-3.9|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||-3.9|-30.9|0.0116
72606249|NCT00676403|144740418|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-9.4|STANDARD_ERROR_OF_MEAN|7.01||0.1819||95.0|-23.2|4.4|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||4.4|-23.2|0.1819
72606250|NCT00676403|144740418|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-7.3|STANDARD_ERROR_OF_MEAN|6.76||0.2806||95.0|-20.6|6.0|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||6.0|-20.6|0.2806
72606251|NCT00676403|144740418|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-10.4|STANDARD_ERROR_OF_MEAN|7.13||0.1465||95.0|-24.4|3.7|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||3.7|-24.4|0.1465
72606252|NCT00676403|144740418|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-19.6|STANDARD_ERROR_OF_MEAN|6.85||0.0046||95.0|-33.1|-6.1|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||-6.1|-33.1|0.0046
72606253|NCT00676403|144740418|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-16.4|STANDARD_ERROR_OF_MEAN|6.92||0.0187||95.0|-30.0|-2.8|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||-2.8|-30.0|0.0187
72606254|NCT00676403|144740418|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.5|STANDARD_ERROR_OF_MEAN|7.0||0.6128||95.0|-10.2|17.3|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||17.3|-10.2|0.6128
72606255|NCT00676403|144740418|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.4|STANDARD_ERROR_OF_MEAN|6.76||0.3488||95.0|-19.7|7.0|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||7.0|-19.7|0.3488
72606256|NCT00676403|144740418|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-10.4|STANDARD_ERROR_OF_MEAN|7.17||0.1472||95.0|-24.5|3.7|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||3.7|-24.5|0.1472
72606257|NCT00676403|144740418|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-12.2|STANDARD_ERROR_OF_MEAN|6.89||0.0791||95.0|-25.7|1.4|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||1.4|-25.7|0.0791
72606258|NCT00676403|144740418|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-15.4|STANDARD_ERROR_OF_MEAN|6.97||0.0282||95.0|-29.1|-1.7|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||-1.7|-29.1|0.0282
72606259|NCT00676403|144740418|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-9.9|STANDARD_ERROR_OF_MEAN|7.08||0.1623||95.0|-23.9|4.0|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||4.0|-23.9|0.1623
72606260|NCT00676403|144740418|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.1|STANDARD_ERROR_OF_MEAN|6.84||0.3739||95.0|-19.6|7.4|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||7.4|-19.6|0.3739
72606261|NCT00676403|144740418|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-14.2|STANDARD_ERROR_OF_MEAN|7.26||0.0517||95.0|-28.5|0.1|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.1|-28.5|0.0517
72606262|NCT00676403|144740418|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-12.1|STANDARD_ERROR_OF_MEAN|6.92||0.0815||95.0|-25.8|1.5|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||1.5|-25.8|0.0815
72606263|NCT00676403|144740418|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-20.9|STANDARD_ERROR_OF_MEAN|7.0||0.0031||95.0|-34.7|-7.1|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||-7.1|-34.7|0.0031
72606264|NCT00676403|144740419|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|7.6|STANDARD_ERROR_OF_MEAN|7.88||0.3368||95.0|-8.0|23.1|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||23.1|-8.0|0.3368
72606265|NCT00676403|144740419|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.2|STANDARD_ERROR_OF_MEAN|7.75||0.4232||95.0|-21.5|9.1|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||9.1|-21.5|0.4232
72606266|NCT00676403|144740419|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.0|STANDARD_ERROR_OF_MEAN|8.09||0.7082||95.0|-12.9|19.0|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||19.0|-12.9|0.7082
72606267|NCT00676403|144740419|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|7.7||0.9466||95.0|-15.7|14.7|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||14.7|-15.7|0.9466
72606268|NCT00676403|144740419|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.9|STANDARD_ERROR_OF_MEAN|7.72||0.3746||95.0|-22.1|8.4|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||8.4|-22.1|0.3746
72606269|NCT00676403|144740419|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.7|STANDARD_ERROR_OF_MEAN|7.95||0.9336||95.0|-15.0|16.3|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||16.3|-15.0|0.9336
72606270|NCT00676403|144740419|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-9.8|STANDARD_ERROR_OF_MEAN|7.71||0.2029||95.0|-25.0|5.4|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||5.4|-25.0|0.2029
72606271|NCT00676403|144740419|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-7.1|STANDARD_ERROR_OF_MEAN|8.18||0.3833||95.0|-23.3|9.0|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||9.0|-23.3|0.3833
72606272|NCT00676403|144740419|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.8|STANDARD_ERROR_OF_MEAN|7.72||0.8152||95.0|-17.0|13.4|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||13.4|-17.0|0.8152
72416514|NCT02314624|144343703|SUPERIORITY|||||||0.15|||||||Chi-squared|GEE Type III chi squared distribution with 1 degrees of freedom was used to examine between-condition change over time from baseline.||We used the Generalized Linear Model to examine the between-condition change over time on study outcomes. We computed the design effects due to this nested design to determine the extent to which the intraclass correlation due to clustering and size of the cluster affected the analyses. Design effects ranged up to 1.8. Because all were under 2.0, we did not adjust analyses to account for clustering effects.||||.15
72416515|NCT02314624|144343704|SUPERIORITY||||||<|0.001|||||||Chi-squared|GEE Type III chi squared distribution with 1 degrees of freedom was used to examine between-condition change over time from baseline.||We used the Generalized Linear Model to examine the between-condition change over time on study outcomes. We computed the design effects due to this nested design to determine the extent to which the intraclass correlation due to clustering and size of the cluster affected the analyses. Design effects ranged up to 1.8. Because all were under 2.0, we did not adjust analyses to account for clustering effects.||||<.001
72416516|NCT02314624|144343705|SUPERIORITY|||||||0.14|||||||Chi-squared|GEE Type III chi squared distribution with 3 degrees of freedom was used to examine between-condition change over time from baseline.||We used the Generalized Linear Model to examine the between-condition change over time on study outcomes. We computed the design effects due to this nested design to determine the extent to which the intraclass correlation due to clustering and size of the cluster affected the analyses. Design effects ranged up to 1.8. Because all were under 2.0, we did not adjust analyses to account for clustering effects.||||.14
72416517|NCT02314624|144343706|SUPERIORITY|||||||0.22|||||||Chi-squared|GEE Type III chi squared distribution with 3 degrees of freedom was used to examine between-condition change over time from baseline.||We used the Generalized Linear Model to examine the between-condition change over time on study outcomes. We computed the design effects due to this nested design to determine the extent to which the intraclass correlation due to clustering and size of the cluster affected the analyses. Design effects ranged up to 1.8. Because all were under 2.0, we did not adjust analyses to account for clustering effects.||||.22
72606273|NCT00676403|144740419|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-10.7|STANDARD_ERROR_OF_MEAN|7.81||0.1739||95.0|-26.1|4.7|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||4.7|-26.1|0.1739
72606274|NCT00676403|144740419|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|7.6|STANDARD_ERROR_OF_MEAN|7.94||0.3392||95.0|-8.0|23.3|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||23.3|-8.0|0.3392
72606275|NCT00676403|144740419|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.8|STANDARD_ERROR_OF_MEAN|7.71||0.913||95.0|-16.0|14.4|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||14.4|-16.0|0.9130
72606276|NCT00676403|144740419|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.3|STANDARD_ERROR_OF_MEAN|8.22||0.6||95.0|-20.5|11.9|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||11.9|-20.5|0.6000
72606277|NCT00676403|144740419|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.9|STANDARD_ERROR_OF_MEAN|7.75||0.4445||95.0|-9.3|21.2|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||21.2|-9.3|0.4445
72606278|NCT00676403|144740419|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|7.85||0.9656||95.0|-15.8|15.1|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||15.1|-15.8|0.9656
72606279|NCT00676403|144740419|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.6|STANDARD_ERROR_OF_MEAN|8.02||0.5679||95.0|-11.2|20.4|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||20.4|-11.2|0.5679
72606280|NCT00676403|144740419|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.5|STANDARD_ERROR_OF_MEAN|7.79||0.5619||95.0|-19.9|10.8|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||10.8|-19.9|0.5619
72606281|NCT00676403|144740419|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|8.31||0.993||95.0|-16.3|16.4|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||16.4|-16.3|0.9930
72606282|NCT00676403|144740419|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.1|STANDARD_ERROR_OF_MEAN|7.79||0.6892||95.0|-12.2|18.5|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||18.5|-12.2|0.6892
72606283|NCT00676403|144740419|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.4|STANDARD_ERROR_OF_MEAN|7.89||0.4928||95.0|-21.0|10.1|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||10.1|-21.0|0.4928
72606284|NCT00676403|144740420|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.6|STANDARD_ERROR_OF_MEAN|5.1||0.2719||95.0|-4.4|15.6|||Mixed Models Analysis|||Week 1: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||15.6|-4.4|0.2719
72416518|NCT02314624|144343707|SUPERIORITY||||||<|0.001|||||||Chi-squared|GEE Type III chi squared distribution with 3 degrees of freedom was used to examine between-condition change over time from baseline.||We used the Generalized Linear Model to examine the between-condition change over time on study outcomes. We computed the design effects due to this nested design to determine the extent to which the intraclass correlation due to clustering and size of the cluster affected the analyses. Design effects ranged up to 1.8. Because all were under 2.0, we did not adjust analyses to account for clustering effects.||||<.001
72416519|NCT02314624|144343708|SUPERIORITY|||||||0.001|||||||Chi-squared|GEE Type III chi squared distribution with 3 degrees of freedom was used to examine between-condition change over time from baseline.||We used the Generalized Linear Model to examine the between-condition change over time on study outcomes. We computed the design effects due to this nested design to determine the extent to which the intraclass correlation due to clustering and size of the cluster affected the analyses. Design effects ranged up to 1.8. Because all were under 2.0, we did not adjust analyses to account for clustering effects.||||.001
72416520|NCT02314624|144343709|SUPERIORITY|||||||0.99|||||||Chi-squared|GEE Type III chi squared distribution with 2 degrees of freedom was used to examine between-condition change over time from baseline.||We used the Generalized Linear Model to examine the between-condition change over time on study outcomes. We computed the design effects due to this nested design to determine the extent to which the intraclass correlation due to clustering and size of the cluster affected the analyses. Design effects ranged up to 1.8. Because all were under 2.0, we did not adjust analyses to account for clustering effects.||||.99
72416521|NCT05090709|144343714|SUPERIORITY||||||>|0.05||||||A priori threshold for statistical significance is 0.05.|ANOVA|Repeated measures ANOVA including all 5 time points in the analysis.||Stiffness values were analysed as a percentage change from baseline measurements to normalise group variances.||||> 0.05
72416522|NCT05090709|144343714|SUPERIORITY||||||>|0.05||||||A priori threshold for statistical significance is 0.05.|ANOVA|Repeated measures ANOVA including all 5 time points in the analysis.||Stiffness values were analysed as a percentage change from baseline measurements to normalise group variances.||||> 0.05
72416523|NCT05090709|144343719|SUPERIORITY||||||<|0.05||||||Including partial eta squared large effect size.|ANOVA|Repeated measures ANOVA including all 5 time points in the analysis.||||||< 0.05
72416524|NCT05090709|144343719|SUPERIORITY||||||<|0.05||||||Including partial eta squared large effect size.|ANOVA|Repeated measures ANOVA including all 5 time points in the analysis.||||||< 0.05
72416525|NCT05090709|144343724|SUPERIORITY||||||>|0.05||||||A priori threshold for statistical significance is 0.05.|ANOVA|Repeated measures ANOVA including all 5 time points in the analysis.||Sit-to-stand velocity values were analysed as a percentage change from baseline measurements to normalise group variances.||||> 0.05
72416526|NCT05090709|144343724|SUPERIORITY||||||>|0.05||||||A priori threshold for statistical significance is 0.05.|ANOVA|Repeated measures ANOVA including all 5 time points in the analysis.||Sit-to-stand velocity values were analysed as a percentage change from baseline measurements to normalise group variances.||||> 0.05
72416527|NCT05090709|144343729|SUPERIORITY||||||>|0.05||||||A priori threshold for statistical significance is 0.05.|ANOVA|Repeated measures ANOVA including all 5 time points in the analysis.||||||> 0.05
72416528|NCT05090709|144343729|SUPERIORITY||||||>|0.05||||||A priori threshold for statistical significance is 0.05.|ANOVA|Repeated measures ANOVA including all 5 time points in the analysis.||||||> 0.05
72416529|NCT05090709|144343731|SUPERIORITY||||||<|0.05||||||Including partial eta squared large effect size.|ANOVA|Repeated measures ANOVA including both time points in the analysis.||||||< 0.05
72416530|NCT05090709|144343731|SUPERIORITY||||||>|0.05||||||A priori threshold for statistical significance is 0.05.|ANOVA|Repeated measures ANOVA including both time points in the analysis.||||||> 0.05
72416531|NCT05090709|144343736|SUPERIORITY||||||>|0.05||||||A priori threshold for statistical significance is 0.05.|ANOVA|Repeated measures ANOVA including all 5 time points in the analysis.||Muscle tone values were analysed as a percentage change from baseline measurements to normalise group variances.||||> 0.05
72416532|NCT05090709|144343736|SUPERIORITY||||||>|0.05||||||A priori threshold for statistical significance is 0.05.|ANOVA|Repeated measures ANOVA including all 5 time points in the analysis.||Muscle tone values were analysed as a percentage change from baseline measurements to normalise group variances.||||> 0.05
72416533|NCT05090709|144343741|SUPERIORITY||||||>|0.05||||||A priori threshold for statistical significance is 0.05.|ANOVA|Repeated measures ANOVA including all 5 time points in the analysis.||||||> 0.05
72416534|NCT05090709|144343741|SUPERIORITY||||||>|0.05||||||A priori threshold for statistical significance is 0.05.|ANOVA|Repeated measures ANOVA including all 5 time points in the analysis.||||||> 0.05
72416535|NCT05090709|144343746|SUPERIORITY||||||>|0.05||||||A priori threshold for statistical significance is 0.05.|ANOVA|Repeated measures ANOVA including all 5 time points in the analysis.||||||> 0.05
72416536|NCT05090709|144343746|SUPERIORITY||||||>|0.05||||||A priori threshold for statistical significance is 0.05.|ANOVA|Repeated measures ANOVA including all 5 time points in the analysis.||||||> 0.05
72416537|NCT05090709|144343751|SUPERIORITY||||||<|0.05||||||Including partial eta squared large effect size.|ANOVA|Repeated measures ANOVA including all 5 time points in the analysis.||||||< 0.05
72416538|NCT05090709|144343751|SUPERIORITY||||||>|0.05||||||A priori threshold for statistical significance is 0.05.|ANOVA|Repeated measures ANOVA including all 5 time points in the analysis.||||||> 0.05
72416539|NCT05090709|144343756|SUPERIORITY||||||>|0.05||||||A priori threshold for statistical significance is 0.05.|ANOVA|Repeated measures ANOVA including all 5 time points in the analysis.||||||> 0.05
72416540|NCT05090709|144343756|SUPERIORITY||||||<|0.05||||||Including partial eta squared large effect size.|ANOVA|Repeated measures ANOVA including all 5 time points in the analysis.||||||< 0.05
72416541|NCT05090709|144343761|SUPERIORITY||||||>|0.05||||||A priori threshold for statistical significance is 0.05.|ANOVA|Repeated measures ANOVA including all 5 time points in the analysis.||||||> 0.05
72416542|NCT05090709|144343761|SUPERIORITY||||||>|0.05||||||A priori threshold for statistical significance is 0.05.|ANOVA|Repeated measures ANOVA including all 5 time points in the analysis.||||||> 0.05
72416543|NCT05090709|144343766|SUPERIORITY||||||<|0.05||||||Including partial eta squared large effect size.|ANOVA|Repeated measures ANOVA including all 5 time points in the analysis.||||||< 0.05
72416544|NCT05090709|144343766|SUPERIORITY||||||<|0.05||||||Including partial eta squared large effect size.|ANOVA|Repeated measures ANOVA including all 5 time points in the analysis.||||||< 0.05
72606285|NCT00676403|144740420|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.0|STANDARD_ERROR_OF_MEAN|5.02||0.693||95.0|-7.9|11.8|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||11.8|-7.9|0.6930
72606286|NCT00676403|144740420|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.9|STANDARD_ERROR_OF_MEAN|5.24||0.7178||95.0|-12.2|8.4|||Mixed Models Analysis|||Week 1: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||8.4|-12.2|0.7178
72606287|NCT00676403|144740420|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.2|STANDARD_ERROR_OF_MEAN|4.96||0.8037||95.0|-11.0|8.5|||Mixed Models Analysis|||Week 1: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||8.5|-11.0|0.8037
72606288|NCT00676403|144740420|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|8.7|STANDARD_ERROR_OF_MEAN|5.02||0.0832||95.0|-1.2|18.6|||Mixed Models Analysis|||Week 1: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||18.6|-1.2|0.0832
72606289|NCT00676403|144740420|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.8|STANDARD_ERROR_OF_MEAN|5.17||0.3554||95.0|-5.4|14.9|||Mixed Models Analysis|||Week 2: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||14.9|-5.4|0.3554
72606290|NCT00676403|144740420|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.3|STANDARD_ERROR_OF_MEAN|4.96||0.9538||95.0|-9.5|10.0|||Mixed Models Analysis|||Week 2: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||10.0|-9.5|0.9538
72606291|NCT00676403|144740420|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.1|STANDARD_ERROR_OF_MEAN|5.26||0.5593||95.0|-13.4|7.3|||Mixed Models Analysis|||Week 2: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||7.3|-13.4|0.5593
72606292|NCT00676403|144740420|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.8|STANDARD_ERROR_OF_MEAN|4.97||0.8663||95.0|-8.9|10.6|||Mixed Models Analysis|||Week 2: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||10.6|-8.9|0.8663
72606293|NCT00676403|144740420|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|8.0|STANDARD_ERROR_OF_MEAN|5.12||0.119||95.0|-2.1|18.1|||Mixed Models Analysis|||Week 2: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||18.1|-2.1|0.1190
72606294|NCT00676403|144740420|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|7.4|STANDARD_ERROR_OF_MEAN|5.15||0.1544||95.0|-2.8|17.5|||Mixed Models Analysis|||Week 4: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||17.5|-2.8|0.1544
72606295|NCT00676403|144740420|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.0|STANDARD_ERROR_OF_MEAN|4.97||0.8439||95.0|-8.8|10.7|||Mixed Models Analysis|||Week 4: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||10.7|-8.8|0.8439
72606296|NCT00676403|144740420|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|5.3||0.9925||95.0|-10.5|10.4|||Mixed Models Analysis|||Week 4: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||10.4|-10.5|0.9925
72606297|NCT00676403|144740420|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.8|STANDARD_ERROR_OF_MEAN|5.02||0.8784||95.0|-9.1|10.6|||Mixed Models Analysis|||Week 4: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||10.6|-9.1|0.8784
72606298|NCT00676403|144740420|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.7|STANDARD_ERROR_OF_MEAN|5.17||0.8948||95.0|-9.5|10.8|||Mixed Models Analysis|||Week 4: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||10.8|-9.5|0.8948
72606299|NCT00676403|144740420|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|6.5|STANDARD_ERROR_OF_MEAN|5.26||0.2197||95.0|-3.9|16.8|||Mixed Models Analysis|||Week 6: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||16.8|-3.9|0.2197
72606300|NCT00676403|144740420|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.5|STANDARD_ERROR_OF_MEAN|5.07||0.6183||95.0|-7.4|12.5|||Mixed Models Analysis|||Week 6: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||12.5|-7.4|0.6183
72606301|NCT00676403|144740420|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.1|STANDARD_ERROR_OF_MEAN|5.42||0.4484||95.0|-14.8|6.5|||Mixed Models Analysis|||Week 6: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||6.5|-14.8|0.4484
72606302|NCT00676403|144740420|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.4|STANDARD_ERROR_OF_MEAN|5.07||0.3857||95.0|-5.6|14.4|||Mixed Models Analysis|||Week 6: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||14.4|-5.6|0.3857
72606303|NCT00676403|144740420|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.8|STANDARD_ERROR_OF_MEAN|5.22||0.8824||95.0|-11.0|9.5|||Mixed Models Analysis|||Week 6: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||9.5|-11.0|0.8824
72416545|NCT00713648|144343768|SUPERIORITY_OR_OTHER||Mean (Lambda)|0.048||||||95.0|0.0094|0.2501|||Poisson model (log-link)|The estimated rate was adjusted for age and overdispersion which was estimated by Pearson's chi-square statistic divided by its degrees of freedom.|Mean (Lambda) refer to the estimate of the annualised bleeding rate|||0.2501|0.0094|
72416546|NCT04386096|144343797|SUPERIORITY|||||||0.08|||||||Wilcoxon (Mann-Whitney)|||||||0.08
72416547|NCT04386096|144343799|SUPERIORITY|||||||0.3|||||||t-test, 2 sided|||Change in Adolescent Pre-Intention Factors||||0.30
72416548|NCT04386096|144343799|SUPERIORITY|||||||0.71|||||||t-test, 2 sided|||Change in Parent Pre-Intention Factors||||0.71
72606304|NCT00676403|144740421|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|10.9|STANDARD_ERROR_OF_MEAN|7.87||0.1673||95.0|-4.6|26.4|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||26.4|-4.6|0.1673
72416549|NCT04386096|144343800|SUPERIORITY|||||||0.29|||||||t-test, 2 sided|||Change in Adolescent Intention to take/give ADHD medicine regularly||||0.29
72606305|NCT00676403|144740421|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|7.71||0.9839||95.0|-15.0|15.3|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||15.3|-15.0|0.9839
72606306|NCT00676403|144740421|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|8.5|STANDARD_ERROR_OF_MEAN|8.06||0.2905||95.0|-7.3|24.4|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||24.4|-7.3|0.2905
72606307|NCT00676403|144740421|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.6|STANDARD_ERROR_OF_MEAN|7.69||0.5513||95.0|-10.6|19.7|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||19.7|-10.6|0.5513
72606308|NCT00676403|144740421|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|11.0|STANDARD_ERROR_OF_MEAN|7.77||0.1589||95.0|-4.3|26.3|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||26.3|-4.3|0.1589
72606309|NCT00676403|144740421|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|15.4|STANDARD_ERROR_OF_MEAN|7.95||0.0541||95.0|-0.3|31.0|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||31.0|-0.3|0.0541
72606310|NCT00676403|144740421|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.0|STANDARD_ERROR_OF_MEAN|7.66||0.5987||95.0|-11.0|19.1|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||19.1|-11.0|0.5987
72416550|NCT04386096|144343800|SUPERIORITY|||||||0.19|||||||t-test, 2 sided|||Change in Parent Intention to take/give ADHD medicine regularly||||0.19
72416551|NCT04386096|144343801|SUPERIORITY|||||||0.64|||||||t-test, 2 sided|||||||0.64
72416552|NCT04386096|144343802|SUPERIORITY|||||||0.81|||||||t-test, 2 sided|||||||0.81
72416553|NCT04386096|144343804|SUPERIORITY|||||||0.1|||||||t-test, 2 sided|||Change in Adolescent: Child Seek||||0.10
72416554|NCT04386096|144343804|SUPERIORITY|||||||0.51|||||||t-test, 2 sided|||Change in Adolescent: Child Express||||0.51
72416555|NCT04386096|144343804|SUPERIORITY|||||||0.84|||||||t-test, 2 sided|||Change in Adolescent: Parent Seek||||0.84
72416556|NCT04386096|144343804|SUPERIORITY|||||||0.93|||||||t-test, 2 sided|||Change in Adolescent: Parent Express||||0.93
72416557|NCT04386096|144343804|SUPERIORITY|||||||0.43|||||||t-test, 2 sided|||Change in Adolescent: Joint/Options||||0.43
72416558|NCT04386096|144343804|SUPERIORITY|||||||0.94|||||||t-test, 2 sided|||Change in Parent: Child Seek||||0.94
72416559|NCT04386096|144343804|SUPERIORITY|||||||0.79|||||||t-test, 2 sided|||Change in Parent: Child Express||||0.79
72416560|NCT04386096|144343804|SUPERIORITY|||||||0.61|||||||t-test, 2 sided|||Change in Parent: Parent Seek||||0.61
72416561|NCT04386096|144343804|SUPERIORITY|||||||0.1|||||||t-test, 2 sided|||Change in Parent: Parent Express||||0.10
72416562|NCT04386096|144343804|SUPERIORITY|||||||0.98|||||||t-test, 2 sided|||Change in Parent: Joint/Options||||0.98
72416563|NCT01992380|144343822|OTHER||ICC|0.971|||||TWO_SIDED|95.0|0.935|0.988|||||Assessed the agreement between the test and retest imaging of the combination VOI SUVr|Intraclass correlation coefficient \[ICC(2,1)\] analysis from Shrout and Fleiss||0.988|0.935|
72416564|NCT01992380|144343823|OTHER||ICC|0.968|||||TWO_SIDED|95.0|0.926|0.986|||||Assessed the agreement between the test and retest imaging of the combination VOI SUVr|Intraclass correlation coefficient \[ICC(2,1)\] analysis from Shrout and Fleiss||0.986|0.926|
72416565|NCT01814371|144343824|NON_INFERIORITY|testing non-inferiority of individualized approach compared to household approach.||||||0.757|||||||Fisher Exact|||||||0.757
72416566|NCT01814371|144343825|NON_INFERIORITY|testing non-inferiority of individualized approach compared to household approach.||||||1|||||||Fisher Exact|||||||1.00
72416567|NCT01814371|144343826|NON_INFERIORITY|testing non-inferiority of individualized approach compared to household approach.||||||0.687|||||||Fisher Exact|||||||0.687
72606311|NCT00676403|144740421|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|6.3|STANDARD_ERROR_OF_MEAN|8.1||0.4372||95.0|-9.6|22.2|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||22.2|-9.6|0.4372
72606312|NCT00676403|144740421|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.6|STANDARD_ERROR_OF_MEAN|7.71||0.8336||95.0|-16.8|13.6|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||13.6|-16.8|0.8336
72606313|NCT00676403|144740421|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|13.9|STANDARD_ERROR_OF_MEAN|7.9||0.0804||95.0|-1.7|29.4|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||29.4|-1.7|0.0804
72606314|NCT00676403|144740421|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|8.3|STANDARD_ERROR_OF_MEAN|7.94||0.2985||95.0|-7.4|23.9|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||23.9|-7.4|0.2985
72606315|NCT00676403|144740421|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.2|STANDARD_ERROR_OF_MEAN|7.66||0.4991||95.0|-9.9|20.3|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||20.3|-9.9|0.4991
72606316|NCT00676403|144740421|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|9.1|STANDARD_ERROR_OF_MEAN|8.15||0.2675||95.0|-7.0|25.1|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||25.1|-7.0|0.2675
72606317|NCT00676403|144740421|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|11.0|STANDARD_ERROR_OF_MEAN|7.77||0.1593||95.0|-4.3|26.3|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||26.3|-4.3|0.1593
72606318|NCT00676403|144740421|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|18.9|STANDARD_ERROR_OF_MEAN|7.96||0.0179||95.0|3.3|34.6|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||34.6|3.3|0.0179
72606319|NCT00676403|144740421|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|17.8|STANDARD_ERROR_OF_MEAN|8.06||0.0281||95.0|1.9|33.7|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||33.7|1.9|0.0281
72606320|NCT00676403|144740421|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|10.3|STANDARD_ERROR_OF_MEAN|7.77||0.1883||95.0|-5.0|25.5|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||25.5|-5.0|0.1883
72606321|NCT00676403|144740421|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|10.0|STANDARD_ERROR_OF_MEAN|8.28||0.23||95.0|-6.3|26.3|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||26.3|-6.3|0.2300
72416568|NCT01814371|144343827|NON_INFERIORITY|testing non-inferiority of individualized approach compared to household approach.||||||1|||||||Fisher Exact|||||||1.00
72416569|NCT01814371|144343828|NON_INFERIORITY|testing non-inferiority of individualized approach compared to household approach.||||||0.811|||||||Fisher Exact|||||||0.811
72416570|NCT01814371|144343829|NON_INFERIORITY|testing non-inferiority of individualized approach compared to household approach.||||||0.004|||||||Fisher Exact|||||||0.004
72416571|NCT01814371|144343830|NON_INFERIORITY|testing non-inferiority of individualized approach compared to household approach.||||||0.006|||||||Fisher Exact|||||||0.006
72416572|NCT01814371|144343831|NON_INFERIORITY|testing non-inferiority of individualized approach compared to household approach.||||||0.05|||||||Fisher Exact|||||||0.050
72416573|NCT01814371|144343832|NON_INFERIORITY|testing non-inferiority of individualized approach compared to household approach.||||||0.007|||||||Fisher Exact|||||||0.007
72416574|NCT01814371|144343833|NON_INFERIORITY|testing non-inferiority of individualized approach compared to household approach.||||||0.005|||||||Fisher Exact|||||||0.005
72416575|NCT01814371|144343834|EQUIVALENCE|testing equivalence of individualized approach compared to household approach.||||||1|||||||Fisher Exact|||||||1.00
72416576|NCT01814371|144343835|EQUIVALENCE|testing equivalence of before and after decolonization protocol.||||||0.84|||||||Chi-squared|||||||0.84
72416577|NCT01814371|144343837|NON_INFERIORITY|testing non-inferiority of individualized approach compared to household approach.||||||0.381|||||||Fisher Exact|||||||0.381
72416578|NCT01814371|144343838|EQUIVALENCE|testing equivalence of individualized approach compared to household approach.||||||0.143|||||||Fisher Exact|||||||0.143
72416579|NCT03252587|144343841|SUPERIORITY||Odds Ratio (OR)|2.8||||0.0006|TWO_SIDED|95.0|1.5|5.1|||Regression, Logistic|1-sided||BMS-986165 3 mg vs Placebo||5.1|1.5|0.0006
72416580|NCT03252587|144343841|SUPERIORITY||Odds Ratio (OR)|1.9||||0.021|TWO_SIDED|95.0|1.0|3.4|||Regression, Logistic|1-sided||BMS-986165 6 mg vs Placebo||3.4|1.0|0.0210
72416581|NCT03252587|144343841|SUPERIORITY||Odds Ratio (OR)|1.6||||0.0781|TWO_SIDED|95.0|0.8|2.9|||Regression, Logistic|1-sided||BMS-986165 12 mg vs Placebo||2.9|0.8|0.0781
72416582|NCT03252587|144343842|SUPERIORITY||Odds Ratio (OR)|2.6||||0.0011|TWO_SIDED|95.0|1.4|4.8|||Regression, Logistic|1-sided||BMS-986165 3 mg vs Placebo||4.8|1.4|0.0011
72416583|NCT03252587|144343842|SUPERIORITY||Odds Ratio (OR)|1.7||||0.0434|TWO_SIDED|95.0|0.9|3.1|||Regression, Logistic|1-sided||BMS-986165 6 mg vs Placebo||3.1|0.9|0.0434
72416584|NCT03252587|144343842|SUPERIORITY||Odds Ratio (OR)|1.7||||0.0439|TWO_SIDED|95.0|0.9|3.1|||Regression, Logistic|1-sided||BMS-986165 12 mg vs Placebo||3.1|0.9|0.0439
72416585|NCT03252587|144343843|SUPERIORITY||Odds Ratio (OR)|2.7||||0.0012|TWO_SIDED|95.0|1.4|5.1|||Regression, Logistic|1-sided||BMS-986165 3 mg vs Placebo||5.1|1.4|0.0012
72416586|NCT03252587|144343843|SUPERIORITY||Odds Ratio (OR)|1.6||||0.0795|TWO_SIDED|95.0|0.8|3.0|||Regression, Logistic|1-sided||BMS-986165 6 mg vs Placebo||3.0|0.8|0.0795
72416587|NCT03252587|144343843|SUPERIORITY||Odds Ratio (OR)|1.6||||0.0673|TWO_SIDED|95.0|0.9|3.2|||Regression, Logistic|1-sided||BMS-986165 12 mg vs Placebo||3.2|0.9|0.0673
72416588|NCT03252587|144343844|SUPERIORITY||Odds Ratio (OR)|4.0||||0.0002|TWO_SIDED|95.0|1.9|8.5|||Regression, Logistic|1-sided||BMS-986165 3 mg vs Placebo||8.5|1.9|0.0002
72416589|NCT03252587|144343844|SUPERIORITY||Odds Ratio (OR)|2.0||||0.0371|TWO_SIDED|95.0|0.9|4.5|||Regression, Logistic|1-sided||BMS-986165 6 mg vs Placebo||4.5|0.9|0.0371
72416590|NCT03252587|144343844|SUPERIORITY||Odds Ratio (OR)|2.3||||0.0168|TWO_SIDED|95.0|1.1|5.1|||Regression, Logistic|1-sided||BMS-986165 12 mg vs Placebo||5.1|1.1|0.0168
72416591|NCT03252587|144343845|SUPERIORITY||Odds Ratio (OR)|10.5||||0.0006|TWO_SIDED|95.0|2.5|43.0|||Regression, Logistic|1-sided||BMS-986165 3 mg vs Placebo||43.0|2.5|0.0006
72416592|NCT03252587|144343845|SUPERIORITY||Odds Ratio (OR)|5.7||||0.0058|TWO_SIDED|95.0|1.5|22.0|||Regression, Logistic|1-sided||BMS-986165 6 mg vs Placebo||22.0|1.5|0.0058
72416593|NCT03252587|144343845|SUPERIORITY||Odds Ratio (OR)|8.2||||0.0009|TWO_SIDED|95.0|2.2|31.0|||Regression, Logistic|1-sided||BMS-986165 12 mg vs Placebo||31.0|2.2|0.0009
72416594|NCT03252587|144343846|SUPERIORITY||Adjusted Mean Difference|-2.3|STANDARD_ERROR_OF_MEAN|1.04||0.0131|TWO_SIDED|95.0|-4.4|-0.3|||Longitudinal Repeated Measures|||Tender BMS-986165 3 mg vs Placebo||-0.3|-4.4|0.0131
72416595|NCT03252587|144343846|SUPERIORITY||Adjusted Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|1.04||0.4156|TWO_SIDED|95.0|-2.3|1.8|||Longitudinal Repeated Measures|||Tender BMS-986165 6 mg vs Placebo||1.8|-2.3|0.4156
72416596|NCT03252587|144343846|SUPERIORITY||Adjusted Mean Difference|-2.4|STANDARD_ERROR_OF_MEAN|1.09||0.0151|TWO_SIDED|95.0|-4.5|-0.2|||Longitudinal Repeated Measures|||Tender BMS-986165 12 mg vs Placebo||-0.2|-4.5|0.0151
72416597|NCT03252587|144343846|SUPERIORITY||Adjusted Mean Difference|-1.3|STANDARD_ERROR_OF_MEAN|0.45||0.0029|TWO_SIDED|95.0|-2.2|-0.4|||Longitudinal Repeated Measures|||Swollen BMS-986165 3 mg vs Placebo||-0.4|-2.2|0.0029
72416598|NCT03252587|144343846|SUPERIORITY||Adjusted Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.46||0.0516|TWO_SIDED|95.0|-1.6|0.2|||Longitudinal Repeated Measures|||Swollen BMS-986165 6 mg vs Placebo||0.2|-1.6|0.0516
72416599|NCT03252587|144343846|SUPERIORITY||Adjusted Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|0.48||0.0298|TWO_SIDED|95.0|-1.8|0.0|||Longitudinal Repeated Measures|||Swollen BMS-986165 12 mg vs Placebo||0.0|-1.8|0.0298
72416600|NCT03252587|144343846|SUPERIORITY||Adjusted Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|0.4||0.001|TWO_SIDED|95.0|-2.0|-0.5|||Longitudinal Repeated Measures|||Tender + Swollen BMS-986165 3 mg vs Placebo||-0.5|-2.0|0.0010
72416601|NCT03252587|144343846|SUPERIORITY||Adjusted Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.4||0.0343|TWO_SIDED|95.0|-1.5|0.1|||Longitudinal Repeated Measures|||Tender + Swollen BMS-986165 6 mg vs Placebo||0.1|-1.5|0.0343
72416602|NCT03252587|144343846|SUPERIORITY||Adjusted Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|0.42||0.005|TWO_SIDED|95.0|-1.9|-0.3|||Longitudinal Repeated Measures|||Tender + Swollen BMS-986165 12 mg vs Placebo||-0.3|-1.9|0.0050
72416603|NCT01515410|144343872|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-6.86||||0.0471||95.0|-13.62|-0.09||This p-value indicates statistical significance at the 0.05 level.|ANCOVA|No subjects early-terminated from the study.||"Percent OFF Time (%)"||-0.09|-13.62|0.0471
72416604|NCT02395042|144343889|SUPERIORITY||Least Squares Mean Difference|-1.15||||0.142|||||||ANCOVA|ANCOVA model with baseline value as a covariate and treatment group and stratification (baseline bladder pain NRS: ≤ 5 or \> 5) as factors.||||||0.142
72416605|NCT02395042|144343889|SUPERIORITY||Least Squares Mean Difference|-0.92||||0.319|||||||ANCOVA|ANCOVA model with baseline value as a covariate and treatment group and stratification (baseline bladder pain NRS: ≤ 5 or \> 5) as factors.||||||0.319
72416606|NCT02395042|144343890|SUPERIORITY||Least Squares Mean Difference|-1.46||||0.024|||||||ANCOVA|ANCOVA model with baseline value as a covariate and treatment group and stratification (baseline bladder pain NRS: ≤ 5 or \> 5) as factors.||||||0.024
72416607|NCT02395042|144343890|SUPERIORITY||Least Squares Mean Difference|-1.02||||0.137|||||||ANCOVA|ANCOVA model with baseline value as a covariate and treatment group and stratification (baseline bladder pain NRS: ≤ 5 or \> 5) as factors.||||||0.137
72606322|NCT00676403|144740421|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.4|STANDARD_ERROR_OF_MEAN|7.82||0.7575||95.0|-13.0|17.8|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||17.8|-13.0|0.7575
72416608|NCT00989768|144343892|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.16|STANDARD_DEVIATION|0.36|<|0.0001||95.0|||||t-test, 2 sided|||In this study the null hypothesis was that BoNT-A1 had the same effect (halus)than the BoNT-A2.||||<0.0001
72606323|NCT00676403|144740421|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|14.3|STANDARD_ERROR_OF_MEAN|8.02||0.0757||95.0|-1.5|30.1|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||30.1|-1.5|0.0757
72416609|NCT00989768|144343893|SUPERIORITY_OR_OTHER|||||||0.003||95.0|||||t-test, 2 sided|||||||0.003
72606324|NCT00676403|144740422|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.4|STANDARD_ERROR_OF_MEAN|5.89||0.2817||95.0|-18.0|5.2|||Mixed Models Analysis|||Week 1: contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||5.2|-18.0|0.2817
72606325|NCT00676403|144740422|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.4|STANDARD_ERROR_OF_MEAN|5.76||0.6796||95.0|-13.7|9.0|||Mixed Models Analysis|||Week 1: contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||9.0|-13.7|0.6796
72606326|NCT00676403|144740422|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.9|STANDARD_ERROR_OF_MEAN|6.01||0.2505||95.0|-18.8|4.9|||Mixed Models Analysis|||Week 1: contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||4.9|-18.8|0.2505
72606327|NCT00676403|144740422|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.8|STANDARD_ERROR_OF_MEAN|5.73||0.5102||95.0|-15.1|7.5|||Mixed Models Analysis|||Week 1: contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||7.5|-15.1|0.5102
72606328|NCT00676403|144740422|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.3|STANDARD_ERROR_OF_MEAN|5.78||0.5706||95.0|-14.7|8.1|||Mixed Models Analysis|||Week 1: contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||8.1|-14.7|0.5706
72606329|NCT00676403|144740422|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.3|STANDARD_ERROR_OF_MEAN|5.95||0.4708||95.0|-16.0|7.4|||Mixed Models Analysis|||Week 2: contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||7.4|-16.0|0.4708
72606330|NCT00676403|144740422|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.8|STANDARD_ERROR_OF_MEAN|5.72||0.6202||95.0|-8.4|14.1|||Mixed Models Analysis|||Week 2: contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||14.1|-8.4|0.6202
72606331|NCT00676403|144740422|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.9|STANDARD_ERROR_OF_MEAN|6.04||0.4177||95.0|-16.8|7.0|||Mixed Models Analysis|||Week 2: contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||7.0|-16.8|0.4177
72416610|NCT00989768|144343894|SUPERIORITY_OR_OTHER|||||||0.61||95.0|||||t-test, 2 sided|||||||0.61
72416611|NCT00989768|144343895|SUPERIORITY_OR_OTHER|||||||0.36||95.0|||||t-test, 2 sided|||||||0.36
72416612|NCT02192502|144343896|NON_INFERIORITY|The non-inferiority delta of a ratio of geometric means is 1.15.|Geometric mean ratio|0.91||||0.15|TWO_SIDED|95.0|0.57|1.44|||generalized linear model|This analysis used linear mixed model with repeated measurements with an unstructured correlation structure.||Assuming that NGAL values follow a log normal distribution as in previous studies with a coefficient of variation of 25%, we need 52 patients per group to have 90% power at the 0.025 significance level to be able to claim non-inferiority of HES to albumin using a non-inferiority delta of a ratio of geometric means of 1.15. After Adjusting for the interim monitoring and five potential dropouts and five pilot patients (which were not included in the analyses), we planned to enroll 140 patients||1.44|0.57|0.15
72416613|NCT02192502|144343897|NON_INFERIORITY|the delta for non-inferiority is 1.15|Risk Ratio (RR)|2.78||||0.92|TWO_SIDED|95.0|0.64|12.1|||Chi-squared|||||12.1|0.64|0.92
72416614|NCT02192502|144343898|NON_INFERIORITY|the non-inferiority delta was 1.15|geometric mean ratio|0.45||||0.002|TWO_SIDED|5.0|0.21|0.95|||Regression, Linear|IL-18 was log-transformed||||0.95|0.21|0.002
72606332|NCT00676403|144740422|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.6|STANDARD_ERROR_OF_MEAN|5.75||0.6509||95.0|-8.7|13.9|||Mixed Models Analysis|||Week 2: contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||13.9|-8.7|0.6509
72416615|NCT02192502|144343899|NON_INFERIORITY|the delta for non-inferiority is 1.15|geometric mean ratio|0.98||||0.31|TWO_SIDED|95.0|0.45|2.1|||Regression, Linear|IL-18 was log-transformed||||2.10|0.45|0.31
72416616|NCT02192502|144343900|NON_INFERIORITY|The non-inferiority delta was 1.15|Risk Ratio (RR)|0.8|||<|0.001|TWO_SIDED|95.0|0.61|1.03|||Chi-squared|||||1.03|0.61|<0.001
72606333|NCT00676403|144740422|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.3|STANDARD_ERROR_OF_MEAN|5.86||0.8273||95.0|-10.3|12.8|||Mixed Models Analysis|||Week 2: contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||12.8|-10.3|0.8273
72606334|NCT00676403|144740422|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.4|STANDARD_ERROR_OF_MEAN|5.94||0.2842||95.0|-18.1|5.3|||Mixed Models Analysis|||Week 4: contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||5.3|-18.1|0.2842
72606335|NCT00676403|144740422|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.2|STANDARD_ERROR_OF_MEAN|5.72||0.7041||95.0|-9.1|13.5|||Mixed Models Analysis|||Week 4: contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||13.5|-9.1|0.7041
72606336|NCT00676403|144740422|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.2|STANDARD_ERROR_OF_MEAN|6.07||0.7216||95.0|-14.1|9.8|||Mixed Models Analysis|||Week 4: contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||9.8|-14.1|0.7216
72606337|NCT00676403|144740422|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.9|STANDARD_ERROR_OF_MEAN|5.78||0.6188||95.0|-14.3|8.5|||Mixed Models Analysis|||Week 4: contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||8.5|-14.3|0.6188
72416617|NCT00584727|144343917|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Chi-squared|||Alternative hypothesis was senofilcon A toric was superior to etafilcon A sphere by having more eyes see 20/20||||<0.0001
72606338|NCT00676403|144740422|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.4|STANDARD_ERROR_OF_MEAN|5.9||0.8096||95.0|-10.2|13.0|||Mixed Models Analysis|||Week 4: contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||13.0|-10.2|0.8096
72606339|NCT00676403|144740422|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-14.6|STANDARD_ERROR_OF_MEAN|6.01||0.0157||95.0|-26.5|-2.8|||Mixed Models Analysis|||Week 6: contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||-2.8|-26.5|0.0157
72606340|NCT00676403|144740422|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.0|STANDARD_ERROR_OF_MEAN|5.79||0.6007||95.0|-14.4|8.4|||Mixed Models Analysis|||Week 6: contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||8.4|-14.4|0.6007
72606341|NCT00676403|144740422|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-10.0|STANDARD_ERROR_OF_MEAN|6.15||0.1057||95.0|-22.1|2.1|||Mixed Models Analysis|||Week 6: contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||2.1|-22.1|0.1057
72606342|NCT00676403|144740422|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.7|STANDARD_ERROR_OF_MEAN|5.81||0.7764||95.0|-13.1|9.8|||Mixed Models Analysis|||Week 6: contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||9.8|-13.1|0.7764
72606343|NCT00676403|144740422|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.2|STANDARD_ERROR_OF_MEAN|5.93||0.7146||95.0|-13.9|9.5|||Mixed Models Analysis|||Week 6: contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||9.5|-13.9|0.7146
72606344|NCT00676403|144740423|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.3|STANDARD_ERROR_OF_MEAN|0.31||0.2978||95.0|-0.3|0.9|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.9|-0.3|0.2978
72606345|NCT00676403|144740423|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.3||0.7242||95.0|-0.5|0.7|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.7|-0.5|0.7242
72606346|NCT00676403|144740423|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.6|STANDARD_ERROR_OF_MEAN|0.32||0.0773||95.0|-0.1|1.2|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||1.2|-0.1|0.0773
72606347|NCT00676403|144740423|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.3||0.7831||95.0|-0.5|0.7|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.7|-0.5|0.7831
72416618|NCT00584727|144343918|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.7155|STANDARD_ERROR_OF_MEAN|0.1334||||95.0|0.3625|0.7155|||Mixed Models Analysis||Mean difference was senofilcon A toric minus etafilcon A sphere.|Alternative hypothesis was senofilcon A toric was superior to etafilcon A sphere.||0.7155|0.3625|
72416619|NCT00584727|144343919|SUPERIORITY_OR_OTHER|||||||0.2161||95.0|||||Chi-squared|||Aletrnative hypothesis was senofilcon A toric was superior to alphafilcon A toric by having more eyes within 5 degrees.||||0.2161
72416620|NCT00584727|144343920|SUPERIORITY_OR_OTHER|||||||0.1328||95.0|||||Chi-squared|||Alternative hypothesis was senofilcon A toric was superior to alphafilcon A toric by having more eyes within 5 degrees||||0.1328
72606348|NCT00676403|144740423|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.3|STANDARD_ERROR_OF_MEAN|0.3||0.3291||95.0|-0.3|0.9|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.9|-0.3|0.3291
72606349|NCT00676403|144740423|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.3|STANDARD_ERROR_OF_MEAN|0.31||0.3692||95.0|-0.3|0.9|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.9|-0.3|0.3692
72606350|NCT00676403|144740423|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.3||0.7614||95.0|-0.5|0.7|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.7|-0.5|0.7614
72606351|NCT00676403|144740423|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.7|STANDARD_ERROR_OF_MEAN|0.32||0.0355||95.0|0.0|1.3|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||1.3|0.0|0.0355
72606352|NCT00676403|144740423|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|0.3||0.5068||95.0|-0.4|0.8|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.8|-0.4|0.5068
72416621|NCT00584727|144343921|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.489|STANDARD_ERROR_OF_MEAN|0.1393||||95.0|0.1529|0.489|||Mixed Models Analysis||Mean difference was senofilcon A toric minus alphafilcon A toric|Alternative hypothesis was senofilcon A toric was superior to alphafilcon A toric.||0.4890|0.1529|
72606353|NCT00676403|144740423|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.6|STANDARD_ERROR_OF_MEAN|0.31||0.0561||95.0|0.0|1.2|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||1.2|-0.0|0.0561
72606354|NCT00676403|144740423|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.4|STANDARD_ERROR_OF_MEAN|0.31||0.2223||95.0|-0.2|1.0|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||1.0|-0.2|0.2223
72606355|NCT00676403|144740423|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.3||0.6791||95.0|-0.5|0.7|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.7|-0.5|0.6791
72416622|NCT00584727|144343922|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Chi-squared|||Alternative hypothesis was senofilcon A toric was superior to etafilcon A sphere.||||<0.0001
72416623|NCT01181050|144343932|SUPERIORITY_OR_OTHER||Treatment difference|-0.02||||0.9334||95.0|-0.54|0.5|||Mixed effect model repeated measures|||||0.50|-0.54|0.9334
72416624|NCT01181050|144343933|SUPERIORITY_OR_OTHER||Treatment difference|0.06||||0.8293||95.0|-0.46|0.58|||Mixed effect model repeated measures|||||0.58|-0.46|0.8293
72606356|NCT00676403|144740423|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.8|STANDARD_ERROR_OF_MEAN|0.32||0.0188||95.0|0.1|1.4|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||1.4|0.1|0.0188
72606357|NCT00676403|144740423|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.5|STANDARD_ERROR_OF_MEAN|0.3||0.1314||95.0|-0.1|1.1|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||1.1|-0.1|0.1314
72416625|NCT01181050|144343934|SUPERIORITY_OR_OTHER||Treatment difference|-0.04||||0.8867||95.0|-0.65|0.56|||Mixed effect model repeated measures|||||0.56|-0.65|0.8867
72416626|NCT01018394|144343935|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.9||||0.108|TWO_SIDED|95.0|0.7|5.1||A one tailed P of less than 0.2 was considered sufficient evidence to warrant a larger study.|Fisher Exact|1 tailed||The percentage of participants who reduced tobacco use by greater or equal to 50% from baseline was compared between groups using Fisher's exact test. A one tailed P of less than 0.2 was considered sufficient evidence to warrant a larger study.||5.1|0.7|0.108
72606358|NCT00676403|144740423|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.5|STANDARD_ERROR_OF_MEAN|0.31||0.09||95.0|-0.1|1.1|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||1.1|-0.1|0.0900
72416627|NCT00683644|144343937|OTHER|The observed power in THQ for zinc is 0.16, and that for placebo is 0.06.|||||>|0.05||||||Threshold for significance is 0.05|Chi-squared|||||||>0.05
72416628|NCT00683644|144343938|OTHER|||||||0.89||||||Threshold for significance is 0.05|paired t test|||||||0.89
72606359|NCT00676403|144740423|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.3|STANDARD_ERROR_OF_MEAN|0.31||0.4144||95.0|-0.4|0.9|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.9|-0.4|0.4144
72606360|NCT00676403|144740423|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.3||0.7699||95.0|-0.5|0.7|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.7|-0.5|0.7699
72606361|NCT00676403|144740423|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.7|STANDARD_ERROR_OF_MEAN|0.32||0.0406||95.0|0.0|1.3|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||1.3|0.0|0.0406
72606362|NCT00676403|144740423|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.3||0.7574||95.0|-0.5|0.7|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.7|-0.5|0.7574
72606363|NCT00676403|144740423|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.6|STANDARD_ERROR_OF_MEAN|0.31||0.0554||95.0|0.0|1.2|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||1.2|-0.0|0.0554
72606364|NCT00676403|144740424|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.3|STANDARD_ERROR_OF_MEAN|5.36||0.5409||95.0|-13.8|7.3|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||7.3|-13.8|0.5409
72416629|NCT00683644|144343938|OTHER|||||||0.36||||||Threshold for significance is 0.05|paired t test|||||||0.36
72416630|NCT00683644|144343939|OTHER|||||||0.64||||||Threshold for significance is 0.05|paired t test|||||||0.64
72416631|NCT00683644|144343939|OTHER|||||||0.93||||||Threshold for significance is 0.05|paired t test|||||||0.93
72416632|NCT01669122|144343940|NON_INFERIORITY_OR_EQUIVALENCE|Testing Bioequivalence|Treatment Ratio|0.96|||||TWO_SIDED|90.0|0.93|0.99||||||Null hypothesis considered no difference in the treatments being compared.||0.99|0.93|
72416633|NCT01669122|144343940|NON_INFERIORITY_OR_EQUIVALENCE|Testing Bioequivalence|Treatment Ratio|0.96|||||TWO_SIDED|90.0|0.93|0.99||||||Null hypothesis considered no difference in the treatments being compared.||0.99|0.93|
72416634|NCT01669122|144343940|NON_INFERIORITY_OR_EQUIVALENCE|Testing Bioequivalence|Treatment Ratio|0.94|||||TWO_SIDED|90.0|0.91|0.97||||||Null hypothesis considered no difference in the treatments being compared.||0.97|0.91|
72606365|NCT00676403|144740424|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.2|STANDARD_ERROR_OF_MEAN|5.25||0.823||95.0|-11.5|9.2|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||9.2|-11.5|0.8230
72416635|NCT01669122|144343941|NON_INFERIORITY_OR_EQUIVALENCE|Testing bioequivalence|Treatment Ratio|0.97|||||TWO_SIDED|90.0|0.93|1.02||||||Null hypothesis considered no difference in the treatments being compared.||1.02|0.93|
72416636|NCT01669122|144343941|NON_INFERIORITY_OR_EQUIVALENCE|Testing Bioequivalence|Treatment Ratio|0.99|||||TWO_SIDED|90.0|0.94|1.03||||||Null hypothesis considered no difference in the treatments being compared.||1.03|0.94|
72416637|NCT01669122|144343941|NON_INFERIORITY_OR_EQUIVALENCE|Testing Bioequivalence|Treatment Ratio|0.92|||||TWO_SIDED|90.0|0.88|0.96||||||Null hypothesis considered no difference in the treatments being compared.||0.96|0.88|
72416638|NCT01669122|144343942|NON_INFERIORITY_OR_EQUIVALENCE|Testing bioequivalence|Treatment Ratio|0.96|||||TWO_SIDED|90.0|0.93|0.99||||||Null hypothesis considered no difference in the treatments being compared.||0.99|0.93|
72416639|NCT01669122|144343942|NON_INFERIORITY_OR_EQUIVALENCE|Testing bioequivalence|Treatment Ratio|0.96|||||TWO_SIDED|90.0|0.93|0.99||||||Null hypothesis considered no difference in the treatments being compared.||0.99|0.93|
72416640|NCT01669122|144343942|NON_INFERIORITY_OR_EQUIVALENCE|Testing bioequivalence|Treatment Ratio|0.93|||||TWO_SIDED|90.0|0.9|0.96||||||Null hypothesis considered no difference in the treatments being compared.||0.96|0.90|
72416641|NCT01669122|144343943|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.2208|TWO_SIDED|95.0|0.0|0.5|||Wilcoxon (Mann-Whitney)||Based on Hodges Lehmann estimate|Null hypothesis considered no difference in the treatments being compared.||0.50|0.00|0.2208
72416642|NCT01669122|144343943|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.5695|TWO_SIDED|95.0|-0.25|0.25|||Wilcoxon (Mann-Whitney)||Based on Hodges Lehmann estimate|Null hypothesis considered no difference in the treatments being compared.||0.25|-0.25|0.5695
72606366|NCT00676403|144740424|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.7|STANDARD_ERROR_OF_MEAN|5.48||0.2958||95.0|-16.5|5.1|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||5.1|-16.5|0.2958
72606367|NCT00676403|144740424|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.7|STANDARD_ERROR_OF_MEAN|5.27||0.3708||95.0|-15.1|5.7|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||5.7|-15.1|0.3708
72416643|NCT01669122|144343943|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.0063|TWO_SIDED|95.0|0.0|0.5|||Wilcoxon (Mann-Whitney)||Based on Hodges Lehmann estimate|Null hypothesis considered no difference in the treatments being compared.||0.50|0.00|0.0063
72416644|NCT00844857|144344001|SUPERIORITY_OR_OTHER|||||||0.003||||||The a priori threshold for statistical significance was 0.05. Mixed Model Repeated Measures Analysis (MMRM) terms included baseline, country, treatment, visit, and treatment \* visit interaction.|Mixed Models Analysis|||"Tested was the null hypothesis that there was no difference in mean changes from baseline to Week 8 between OFC and placebo.~A conservative estimate of effect size of 0.4 was used in the sample size estimation for this study. A randomized ratio of 2:1 provided a 90% power with an effect size of 0.4."||||0.003
72416645|NCT00844857|144344002|SUPERIORITY_OR_OTHER|||||||0.035||||||The a priori threshold for statistical significance was 0.05.|Fisher Exact|||Tested was the null hypothesis that there was no difference in proportions between OFC and placebo.||||0.035
72416646|NCT00844857|144344003|SUPERIORITY_OR_OTHER|||||||0.003||||||The a priori threshold for statistical significance was 0.05.|Fisher Exact|||Tested was the null hypothesis that there was no difference in proportions between OFC and placebo.||||0.003
72416647|NCT00844857|144344004|SUPERIORITY_OR_OTHER|||||||0.007||||||The a priori threshold for statistical significance was 0.05. Ordinal Logistic Regression Model terms include baseline CDRS-R, baseline YMRS, and treatment.|Ordinal Logistic Regression|||Tested was the null hypothesis that there was no difference in proportions between OFC and placebo.||||0.007
72416648|NCT00844857|144344005|SUPERIORITY_OR_OTHER|||||||0.527||||||The a priori threshold for statistical significance was 0.05. MMRM terms included baseline, country, treatment, visit, and treatment\*visit interaction.|Mixed Models Analysis|||Tested was the null hypothesis that there was no difference in mean changes from baseline to Week 8 between OFC and placebo.||||0.527
72416649|NCT00844857|144344006|SUPERIORITY_OR_OTHER|||||||0.03||||||The a priori threshold for statistical significance was 0.05. MMRM terms included baseline, country, treatment, visit, and treatment\*visit interaction|Mixed Models Analysis|||Tested was the null hypothesis that there was no difference in mean changes from baseline to Week 8 between OFC and placebo.||||0.030
72416650|NCT00844857|144344007|SUPERIORITY_OR_OTHER|||||||0.002||||||The a priori threshold for statistical significance was 0.05. ANCOVA (analysis of covariance) Model terms included baseline, country, and treatment.|ANCOVA|||Tested was the null hypothesis that there was no difference in mean changes from baseline to up to Week 8 between OFC and placebo.||||0.002
72416651|NCT00844857|144344008|SUPERIORITY_OR_OTHER|||||||1||||||The a priori threshold for statistical significance was 0.05.|Fisher Exact|||Tested was the null hypothesis that there was no difference in proportions between OFC and placebo.||||1.00
72416652|NCT00844857|144344009|SUPERIORITY_OR_OTHER|||||||0.309||||||P-value for Suicidal Ideation. The a priori threshold for statistical significance was 0.05.|Fisher Exact|||Tested was the null hypothesis that there was no difference in proportions between OFC and placebo.||||0.309
72606368|NCT00676403|144740424|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-7.0|STANDARD_ERROR_OF_MEAN|5.27||0.1853||95.0|-17.4|3.4|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||3.4|-17.4|0.1853
72606369|NCT00676403|144740424|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-7.2|STANDARD_ERROR_OF_MEAN|5.41||0.1834||95.0|-17.9|3.4|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||3.4|-17.9|0.1834
72416653|NCT00844857|144344009|SUPERIORITY_OR_OTHER|||||||0.667||||||P-value for Suicidal Behavior. The a priori threshold for statistical significance was 0.05.|Fisher Exact|||Tested was the null hypothesis that there was no difference in proportions between OFC and placebo.||||0.667
72416654|NCT00844857|144344009|SUPERIORITY_OR_OTHER|||||||0.309||||||P-value for Suicidal Ideation or Behavior. The a priori threshold for statistical significance was 0.05.|Fisher Exact|||Tested was the null hypothesis that there was no difference in proportions between OFC and placebo.||||0.309
72416655|NCT00844857|144344010|SUPERIORITY_OR_OTHER|||||||1||||||The a priori threshold for statistical significance was 0.05.|Fisher Exact|||Tested was the null hypothesis that there was no difference in proportions between OFC and placebo.||||1.00
72416656|NCT00844857|144344011|SUPERIORITY_OR_OTHER|||||||0.545||||||P-value for ADHDRS-IV-PI Total Score. The a priori threshold for statistical significance was 0.05. ANCOVA Model terms included baseline, country and treatment.|ANCOVA|||Tested was the null hypothesis that there was no difference in mean changes from baseline to up to Week 8 between OFC and placebo.||||0.545
72416657|NCT00844857|144344012|SUPERIORITY_OR_OTHER|||||||0.066||||||The a priori threshold for statistical significance was 0.05. ANCOVA Model terms included baseline, country and treatment.|ANCOVA|||Tested was the null hypothesis that there was no difference in mean changes from baseline to up to Week 8 between OFC and placebo.||||0.066
72416658|NCT00844857|144344013|SUPERIORITY_OR_OTHER|||||||1||||||The a priori threshold for statistical significance was 0.05.|Fisher Exact|||Tested was the null hypothesis that there was no difference in proportions between OFC and placebo.||||1.00
72416659|NCT00844857|144344014|SUPERIORITY_OR_OTHER|||||||1||||||The a priori threshold for statistical significance was 0.05.|Fisher Exact|||Tested was the null hypothesis that there was no difference in proportions between OFC and placebo.||||1.00
72416660|NCT00844857|144344015|SUPERIORITY_OR_OTHER|||||||0.05||||||The a priori threshold for statistical significance was 0.05. ANCOVA Model terms included baseline, country and treatment.|ANCOVA|||Tested was the null hypothesis that there was no difference in mean changes from baseline to up to Week 8 between OFC and placebo.||||0.050
72416661|NCT00844857|144344016|SUPERIORITY_OR_OTHER||||||<|0.001||||||The a priori threshold for statistical significance was 0.05. ANCOVA Model terms included baseline and treatment.|ANCOVA|||Tested was the null hypothesis that there was no difference in mean changes from baseline to up to Week 8 between OFC and placebo.||||<0.001
72416662|NCT00844857|144344017|SUPERIORITY_OR_OTHER|||||||0.98||||||P-value for Fasting Glucose. The a priori threshold for statistical significance was 0.05. ANCOVA Model terms included baseline and treatment.|ANCOVA|||Tested was the null hypothesis that there was no difference in mean changes from baseline to up to Week 8 between OFC and placebo.||||0.980
72606370|NCT00676403|144740424|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.8|STANDARD_ERROR_OF_MEAN|5.22||0.8711||95.0|-11.1|9.4|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||9.4|-11.1|0.8711
72606371|NCT00676403|144740424|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.4|STANDARD_ERROR_OF_MEAN|5.5||0.3252||95.0|-16.3|5.4|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||5.4|-16.3|0.3252
72606372|NCT00676403|144740424|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.3|STANDARD_ERROR_OF_MEAN|5.28||0.3205||95.0|-15.7|5.1|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||5.1|-15.7|0.3205
72606373|NCT00676403|144740424|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-9.3|STANDARD_ERROR_OF_MEAN|5.34||0.0837||95.0|-19.8|1.2|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||1.2|-19.8|0.0837
72606374|NCT00676403|144740424|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.8|STANDARD_ERROR_OF_MEAN|5.4||0.8895||95.0|-11.4|9.9|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||9.9|-11.4|0.8895
72606375|NCT00676403|144740424|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.4|STANDARD_ERROR_OF_MEAN|5.22||0.6469||95.0|-12.7|7.9|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||7.9|-12.7|0.6469
72606376|NCT00676403|144740424|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.1|STANDARD_ERROR_OF_MEAN|5.53||0.2687||95.0|-17.0|4.8|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||4.8|-17.0|0.2687
72606377|NCT00676403|144740424|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-7.2|STANDARD_ERROR_OF_MEAN|5.31||0.1757||95.0|-17.7|3.3|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||3.3|-17.7|0.1757
72606378|NCT00676403|144740424|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-11.7|STANDARD_ERROR_OF_MEAN|5.38||0.0306||95.0|-22.3|-1.1|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||-1.1|-22.3|0.0306
72606379|NCT00676403|144740424|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-9.4|STANDARD_ERROR_OF_MEAN|5.47||0.0857||95.0|-20.2|1.3|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||1.3|-20.2|0.0857
72606380|NCT00676403|144740424|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.6|STANDARD_ERROR_OF_MEAN|5.28||0.2932||95.0|-16.0|4.8|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||4.8|-16.0|0.2932
72606381|NCT00676403|144740424|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-10.5|STANDARD_ERROR_OF_MEAN|5.6||0.0613||95.0|-21.6|0.5|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.5|-21.6|0.0613
72606382|NCT00676403|144740424|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.3|STANDARD_ERROR_OF_MEAN|5.34||0.5431||95.0|-13.8|7.3|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||7.3|-13.8|0.5431
72606383|NCT00676403|144740424|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-12.1|STANDARD_ERROR_OF_MEAN|5.41||0.0262||95.0|-22.7|-1.4|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||-1.4|-22.7|0.0262
72606384|NCT00676403|144740425|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-7.8|STANDARD_ERROR_OF_MEAN|5.44||0.1547||95.0|-18.5|3.0|||Mixed Models Analysis|||Week 1: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||3.0|-18.5|0.1547
72606385|NCT00676403|144740425|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.1|STANDARD_ERROR_OF_MEAN|5.33||0.2532||95.0|-16.6|4.4|||Mixed Models Analysis|||Week 1: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||4.4|-16.6|0.2532
72606386|NCT00676403|144740425|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-9.6|STANDARD_ERROR_OF_MEAN|5.56||0.0848||95.0|-20.6|1.3|||Mixed Models Analysis|||Week 1: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||1.3|-20.6|0.0848
72606387|NCT00676403|144740425|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.3|STANDARD_ERROR_OF_MEAN|5.36||0.2424||95.0|-16.8|4.3|||Mixed Models Analysis|||Week 1: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||4.3|-16.8|0.2424
72606388|NCT00676403|144740425|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-10.7|STANDARD_ERROR_OF_MEAN|5.35||0.047||95.0|-21.2|-0.1|||Mixed Models Analysis|||Week 1: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||-0.1|-21.2|0.0470
72606389|NCT00676403|144740425|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-7.9|STANDARD_ERROR_OF_MEAN|5.49||0.1494||95.0|-18.8|2.9|||Mixed Models Analysis|||Week 2: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||2.9|-18.8|0.1494
72606390|NCT00676403|144740425|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.5|STANDARD_ERROR_OF_MEAN|5.3||0.5081||95.0|-13.9|6.9|||Mixed Models Analysis|||Week 2: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||6.9|-13.9|0.5081
72606391|NCT00676403|144740425|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-7.0|STANDARD_ERROR_OF_MEAN|5.58||0.2141||95.0|-17.9|4.0|||Mixed Models Analysis|||Week 2: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||4.0|-17.9|0.2141
72606392|NCT00676403|144740425|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-7.8|STANDARD_ERROR_OF_MEAN|5.37||0.1484||95.0|-18.4|2.8|||Mixed Models Analysis|||Week 2: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||2.8|-18.4|0.1484
72606393|NCT00676403|144740425|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-9.0|STANDARD_ERROR_OF_MEAN|5.42||0.0963||95.0|-19.7|1.6|||Mixed Models Analysis|||Week 2: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||1.6|-19.7|0.0963
72416663|NCT00844857|144344017|SUPERIORITY_OR_OTHER||||||<|0.001||||||P-value for Fasting Cholesterol. The a priori threshold for statistical significance was 0.05. ANCOVA Model terms included baseline and treatment|ANCOVA|||Tested was the null hypothesis that there was no difference in mean changes from baseline to up to Week 8 between OFC and placebo.||||<0.001
72606394|NCT00676403|144740425|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.0|STANDARD_ERROR_OF_MEAN|5.48||0.8519||95.0|-11.8|9.8|||Mixed Models Analysis|||Week 4: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||9.8|-11.8|0.8519
72606395|NCT00676403|144740425|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.8|STANDARD_ERROR_OF_MEAN|5.3||0.477||95.0|-14.2|6.7|||Mixed Models Analysis|||Week 4: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||6.7|-14.2|0.4770
72606396|NCT00676403|144740425|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.9|STANDARD_ERROR_OF_MEAN|5.61||0.2166||95.0|-18.0|4.1|||Mixed Models Analysis|||Week 4: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||4.1|-18.0|0.2166
72606397|NCT00676403|144740425|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-8.8|STANDARD_ERROR_OF_MEAN|5.4||0.1062||95.0|-19.4|1.9|||Mixed Models Analysis|||Week 4: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||1.9|-19.4|0.1062
72606398|NCT00676403|144740425|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-10.9|STANDARD_ERROR_OF_MEAN|5.45||0.0475||95.0|-21.6|-0.1|||Mixed Models Analysis|||Week 4: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||-0.1|-21.6|0.0475
72606399|NCT00676403|144740425|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-10.7|STANDARD_ERROR_OF_MEAN|5.54||0.0537||95.0|-21.7|0.2|||Mixed Models Analysis|||Week 6: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.2|-21.7|0.0537
72606400|NCT00676403|144740425|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.4|STANDARD_ERROR_OF_MEAN|5.35||0.3153||95.0|-15.9|5.2|||Mixed Models Analysis|||Week 6: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||5.2|-15.9|0.3153
72606401|NCT00676403|144740425|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-11.6|STANDARD_ERROR_OF_MEAN|5.68||0.0424||95.0|-22.8|-0.4|||Mixed Models Analysis|||Week 6: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||-0.4|-22.8|0.0424
72606402|NCT00676403|144740425|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.5|STANDARD_ERROR_OF_MEAN|5.42||0.3077||95.0|-16.2|5.1|||Mixed Models Analysis|||Week 6: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||5.1|-16.2|0.3077
72606403|NCT00676403|144740425|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-12.6|STANDARD_ERROR_OF_MEAN|5.48||0.0224||95.0|-23.4|-1.8|||Mixed Models Analysis|||Week 6: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||-1.8|-23.4|0.0224
72606404|NCT00676403|144740426|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|3.7|STANDARD_ERROR_OF_MEAN|2.65||0.0646||95.0|0.9|15.0|||Regression, Logistic|||Week 1: Contrast of treatment vs. placebo. Differences in proportions were obtained using LS means. Repeated measures logistic regression model used fixed effects including treatment, geographic region, week, and the treatment by week interaction. The within-subject covariance structure was modeled as compound sysmetric.||15.0|0.9|0.0646
72606405|NCT00676403|144740426|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.2|STANDARD_ERROR_OF_MEAN|1.58||0.2947||95.0|0.5|9.1|||Regression, Logistic|||Week 1: Contrast of treatment vs. placebo. Differences in proportions were obtained using LS means. Repeated measures logistic regression model used fixed effects including treatment, geographic region, week, and the treatment by week interaction. The within-subject covariance structure was modeled as compound sysmetric.||9.1|0.5|0.2947
72606406|NCT00676403|144740426|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|4.6|STANDARD_ERROR_OF_MEAN|3.1||0.0249||95.0|1.2|17.2|||Regression, Logistic|||Week 1: Contrast of treatment vs. placebo. Differences in proportions were obtained using LS means. Repeated measures logistic regression model used fixed effects including treatment, geographic region, week, and the treatment by week interaction. The within-subject covariance structure was modeled as compound sysmetric.||17.2|1.2|0.0249
72606407|NCT00676403|144740426|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.3|STANDARD_ERROR_OF_MEAN|0.99||0.7671||95.0|0.3|5.9|||Regression, Logistic|||Week 1: Contrast of treatment vs. placebo. Differences in proportions were obtained using LS means. Repeated measures logistic regression model used fixed effects including treatment, geographic region, week, and the treatment by week interaction. The within-subject covariance structure was modeled as compound sysmetric.||5.9|0.3|0.7671
72606408|NCT00676403|144740426|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|4.6|STANDARD_ERROR_OF_MEAN|2.9||0.0169||95.0|1.3|15.9|||Regression, Logistic|||Week 1: Contrast of treatment vs. placebo. Differences in proportions were obtained using LS means. Repeated measures logistic regression model used fixed effects including treatment, geographic region, week, and the treatment by week interaction. The within-subject covariance structure was modeled as compound sysmetric.||15.9|1.3|0.0169
72606409|NCT00676403|144740426|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.0|STANDARD_ERROR_OF_MEAN|0.74||0.9569||95.0|0.2|4.3|||Regression, Logistic|||Week 2: Contrast of treatment vs. placebo. Differences in proportions were obtained using LS means. Repeated measures logistic regression model used fixed effects including treatment, geographic region, week, and the treatment by week interaction. The within-subject covariance structure was modeled as compound sysmetric.||4.3|0.2|0.9569
72606410|NCT00676403|144740426|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|3.2|STANDARD_ERROR_OF_MEAN|2.07||0.0711||95.0|0.9|11.4|||Regression, Logistic|||Week 2: Contrast of treatment vs. placebo. Differences in proportions were obtained using LS means.Repeated measures logistic regression model used fixed effects including treatment, geographic region, week, and the treatment by week interaction. The within-subject covariance structure was modeled as compound sysmetric.||11.4|0.9|0.0711
72606411|NCT00676403|144740426|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.8|STANDARD_ERROR_OF_MEAN|1.85||0.1073||95.0|0.8|10.2|||Regression, Logistic|||Week 2: Contrast of treatment vs. placebo. Differences in proportions were obtained using LS means. Repeated measures logistic regression model used fixed effects including treatment, geographic region, week, and the treatment by week interaction. The within-subject covariance structure was modeled as compound sysmetric.||10.2|0.8|0.1073
72416664|NCT00844857|144344017|SUPERIORITY_OR_OTHER||||||<|0.001||||||P-value for Fasting Triglycerides. The a priori threshold for statistical significance was 0.05. ANCOVA Model terms included baseline and treatment.|ANCOVA|||Tested was the null hypothesis that there was no difference in mean changes from baseline to up to Week 8 between OFC and placebo.||||<0.001
72416665|NCT00844857|144344018|SUPERIORITY_OR_OTHER|||||||0.005||||||The a priori threshold for statistical significance was 0.05. ANCOVA Model terms included baseline and treatment.|ANCOVA|||Tested was the null hypothesis that there was no difference in mean changes from baseline to up to Week 8 between OFC and placebo.||||0.005
72416666|NCT00844857|144344019|SUPERIORITY_OR_OTHER||||||<|0.001||||||The a priori threshold for statistical significance was 0.05. ANCOVA Model terms included baseline and treatment.|ANCOVA|||Tested was the null hypothesis that there was no difference in mean changes from baseline to up to Week 8 between OFC and placebo.||||<0.001
72606412|NCT00676403|144740426|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.4|STANDARD_ERROR_OF_MEAN|1.48||0.1583||95.0|0.7|8.1|||Regression, Logistic|||Week 2: Contrast of treatment vs. placebo. Differences in proportions were obtained using LS means. Repeated measures logistic regression model used fixed effects including treatment, geographic region, week, and the treatment by week interaction. The within-subject covariance structure was modeled as compound sysmetric.||8.1|0.7|0.1583
72606413|NCT00676403|144740426|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|4.1|STANDARD_ERROR_OF_MEAN|2.8||0.0385||95.0|1.1|15.6|||Regression, Logistic|||Week 2: Contrast of treatment vs. placebo. Differences in proportions were obtained using LS means. Repeated measures logistic regression model used fixed effects including treatment, geographic region, week, and the treatment by week interaction. The within-subject covariance structure was modeled as compound sysmetric.||15.6|1.1|0.0385
72606414|NCT00676403|144740426|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.6|STANDARD_ERROR_OF_MEAN|1.09||0.4923||95.0|0.4|6.1|||Regression, Logistic|||Week 4: Contrast of treatment vs. placebo. Differences in proportions were obtained using LS means. Repeated measures logistic regression model used fixed effects including treatment, geographic region, week, and the treatment by week interaction. The within-subject covariance structure was modeled as compound sysmetric.||6.1|0.4|0.4923
72606415|NCT00676403|144740426|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.3|STANDARD_ERROR_OF_MEAN|0.8||0.7169||95.0|0.4|4.4|||Regression, Logistic|||Week 4: Contrast of treatment vs. placebo. Differences in proportions were obtained using LS means. Repeated measures logistic regression model used fixed effects including treatment, geographic region, week, and the treatment by week interaction. The within-subject covariance structure was modeled as compound sysmetric.||4.4|0.4|0.7169
72606416|NCT00676403|144740426|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.7|STANDARD_ERROR_OF_MEAN|1.12||0.4156||95.0|0.5|6.2|||Regression, Logistic|||Week 4: Contrast of treatment vs. placebo. Differences in proportions were obtained using LS means. Repeated measures logistic regression model used fixed effects including treatment, geographic region, week, and the treatment by week interaction. The within-subject covariance structure was modeled as compound sysmetric.||6.2|0.5|0.4156
72606417|NCT00676403|144740426|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.7|STANDARD_ERROR_OF_MEAN|1.04||0.4165||95.0|0.5|5.6|||Regression, Logistic|||Week 4: Contrast of treatment vs. placebo. Differences in proportions were obtained using LS means. Repeated measures logistic regression model used fixed effects including treatment, geographic region, week, and the treatment by week interaction. The within-subject covariance structure was modeled as compound sysmetric.||5.6|0.5|0.4165
72606418|NCT00676403|144740426|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.6|STANDARD_ERROR_OF_MEAN|1.08||0.4673||95.0|0.4|6.0|||Regression, Logistic|||Week 4: Contrast of treatment vs. placebo. Differences in proportions were obtained using LS means. Repeated measures logistic regression model used fixed effects including treatment, geographic region, week, and the treatment by week interaction. The within-subject covariance structure was modeled as compound sysmetric.||6.0|0.4|0.4673
72606419|NCT00676403|144740426|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.0|STANDARD_ERROR_OF_MEAN|0.72||0.9855||95.0|0.2|4.1|||Regression, Logistic|||Week 6: Contrast of treatment vs. placebo. Differences in proportions were obtained using LS means. Repeated measures logistic regression model used fixed effects including treatment, geographic region, week, and the treatment by week interaction. The within-subject covariance structure was modeled as compound sysmetric.||4.1|0.2|0.9855
72606420|NCT00676403|144740426|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.0|STANDARD_ERROR_OF_MEAN|0.61||0.9566||95.0|0.3|3.3|||Regression, Logistic|||Week 6: Contrast of treatment vs. placebo. Differences in proportions were obtained using LS means. Repeated measures logistic regression model used fixed effects including treatment, geographic region, week, and the treatment by week interaction. The within-subject covariance structure was modeled as compound sysmetric.||3.3|0.3|0.9566
72416667|NCT00844857|144344020|SUPERIORITY_OR_OTHER||||||<|0.001||||||The a priori threshold for statistical significance was 0.05. ANCOVA Model terms included baseline and treatment.|ANCOVA|||Tested was the null hypothesis that there was no difference in mean changes from baseline to up to Week 8 between OFC and placebo.||||<0.001
72606421|NCT00676403|144740426|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.7|STANDARD_ERROR_OF_MEAN|1.17||0.4632||95.0|0.4|6.6|||Regression, Logistic|||Week 6: Contrast of treatment vs. placebo. Differences in proportions were obtained using LS means. Repeated measures logistic regression model used fixed effects including treatment, geographic region, week, and the treatment by week interaction. The within-subject covariance structure was modeled as compound sysmetric.||6.6|0.4|0.4632
72606422|NCT00676403|144740426|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.4|STANDARD_ERROR_OF_MEAN|0.29||0.2042||95.0|0.1|1.6|||Regression, Logistic|||Week 6: Contrast of treatment vs. placebo. Differences in proportions were obtained using LS means. Repeated measures logistic regression model used fixed effects including treatment, geographic region, week, and the treatment by week interaction. The within-subject covariance structure was modeled as compound sysmetric.||1.6|0.1|0.2042
72606423|NCT00676403|144740426|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.9|STANDARD_ERROR_OF_MEAN|1.34||0.3382||95.0|0.5|7.5|||Regression, Logistic|||Week 6: Contrast of treatment vs. placebo. Differences in proportions were obtained using LS means. Repeated measures logistic regression model used fixed effects including treatment, geographic region, week, and the treatment by week interaction. The within-subject covariance structure was modeled as compound sysmetric.||7.5|0.5|0.3382
72606424|NCT00676403|144740427|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.6||||0.3932||95.0|-6.0|15.2|||ANCOVA|||Analysis of covariance of change from baseline; LS Mean, standard error, 95% CI and P-value are from an analysis of covariance (ANCOVA), with treatment and geographic region as main effects and baseline value as covariate in the model.||15.2|-6.0|0.3932
72606425|NCT00676403|144740427|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|7.3||||0.1585||95.0|-2.9|17.5|||ANCOVA|||Analysis of covariance of change from baseline; LS Mean, standard error, 95% CI and P-value are from an analysis of covariance (ANCOVA), with treatment and geographic region as main effects and baseline value as covariate in the model.||17.5|-2.9|0.1585
72606426|NCT00676403|144740427|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.8||||0.285||95.0|-4.9|16.5|||ANCOVA|||Analysis of covariance of change from baseline; LS Mean, standard error, 95% CI and P-value are from an analysis of covariance (ANCOVA), with treatment and geographic region as main effects and baseline value as covariate in the model.||16.5|-4.9|0.2850
72606427|NCT00676403|144740427|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.9||||0.8645||95.0|-9.4|11.1|||ANCOVA|||Analysis of covariance of change from baseline; LS Mean, standard error, 95% CI and P-value are from an analysis of covariance (ANCOVA), with treatment and geographic region as main effects and baseline value as covariate in the model.||11.1|-9.4|0.8645
72606428|NCT00676403|144740427|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.4||||0.3031||95.0|-5.0|15.8|||ANCOVA|||Analysis of covariance of change from baseline; LS Mean, standard error, 95% CI and P-value are from an analysis of covariance (ANCOVA), with treatment and geographic region as main effects and baseline value as covariate in the model.||15.8|-5.0|0.3031
72606429|NCT00676403|144740428|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.1||||0.5384||95.0|-13.2|7.0|||ANCOVA|||Physical Functioning: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.||7.0|-13.2|0.5384
72606430|NCT00676403|144740428|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.2||||0.8015||95.0|-10.9|8.5|||ANCOVA|||Physical Functioning: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.||8.5|-10.9|0.8015
72606431|NCT00676403|144740428|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.1||||0.4429||95.0|-14.5|6.4|||ANCOVA|||Physical Functioning: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.||6.4|-14.5|0.4429
72606432|NCT00676403|144740428|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.7||||0.886||95.0|-10.5|9.1|||ANCOVA|||Physical Functioning: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.||9.1|-10.5|0.8860
72606433|NCT00676403|144740428|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0||||0.9963||95.0|-10.0|9.9|||ANCOVA|||Physical Functioning: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.||9.9|-10.0|0.9963
72606434|NCT00676403|144740428|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.9||||0.3421||95.0|-6.3|18.1|||ANCOVA|||Role-Physical: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.||18.1|-6.3|0.3421
72606435|NCT00676403|144740428|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|6.4||||0.2849||95.0|-5.4|18.1|||ANCOVA|||Role-Physical: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.||18.1|-5.4|0.2849
72606436|NCT00676403|144740428|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|6.6||||0.3058||95.0|-6.1|19.2|||ANCOVA|||Role-Physical: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.||19.2|-6.1|0.3058
72416668|NCT03901326|144344102|OTHER|||||||0.05|||||||Chi-squared|||Rate of ICA without obstructive CAD or intervention within 90 days||||0.05
72416669|NCT03901326|144344102|OTHER||||||<|0.001|||||||Chi-squared|||Rate of patients underwent revascularization||||<0.001
72416670|NCT03901326|144344103|OTHER||Hazard Ratio (HR)|0.88||||0.8|TWO_SIDED|95.0|0.59|1.3|||Regression, Cox|||||1.30|0.59|0.80
72416671|NCT03901326|144344104|OTHER|||||||0.07|||||||Wilcoxon (Mann-Whitney)|||||||0.07
72606437|NCT00676403|144740428|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.3||||0.9604||95.0|-12.1|11.5|||ANCOVA|||Role-Physical: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.||11.5|-12.1|0.9604
72416672|NCT03901326|144344105|OTHER|||||||0.15|||||||t-test, 2 sided|||||||0.15
72416673|NCT01692782|144344107|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.7|||||TWO_SIDED||||||Mixed Models Analysis|||The 4 mg and 8 mg SEP 225289 groups were compared to placebo using a MMRM analysis. The MMRM model included treatment, visit (as a categorical variable), pooled center, baseline ADHD RS-IV with adult prompts score, and treatment-by-visit interaction. An unstructured covariance matrix was used for the within subject correlation.||||
72416674|NCT01692782|144344107|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.38||||0.076|TWO_SIDED||||||Mixed Models Analysis|P-values of SEP 225289 4 mg versus placebo at Week 4 was adjusted for multiple comparisons using the Hochberg procedure.||The 4 mg SEP 225289 group was compared to placebo using a MMRM analysis. The MMRM model included treatment, visit (as a categorical variable), pooled center, baseline ADHD RS-IV with adult prompts score, and treatment-by-visit interaction. An unstructured covariance matrix was used for the within subject correlation.||||0.076
72416675|NCT01692782|144344107|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.88||||0.019|TWO_SIDED|||||p-value of SEP 225289 8 mg versus placebo at Week 4 was adjusted for multiple comparisons using the Hochberg procedure.|Mixed Models Analysis|||The 8 mg SEP 225289 group was compared to placebo using a MMRM analysis. The MMRM model included treatment, visit (as a categorical variable), pooled center, baseline ADHD RS-IV with adult prompts score, and treatment-by-visit interaction. An unstructured covariance matrix was used for the within subject correlation.||||0.019
72606438|NCT00676403|144740428|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|8.5||||0.1661||95.0|-3.6|20.6|||ANCOVA|||Role-Physical: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.||20.6|-3.6|0.1661
72606439|NCT00676403|144740428|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|8.9||||0.1441||95.0|-3.1|20.9|||ANCOVA|||Bodily Pain: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.||20.9|-3.1|0.1441
72606440|NCT00676403|144740428|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|6.0||||0.3076||95.0|-5.6|17.5|||ANCOVA|||Bodily Pain: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.||17.5|-5.6|0.3076
72606441|NCT00676403|144740428|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|10.0||||0.1209||95.0|-2.7|22.7|||ANCOVA|||Bodily Pain: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.||22.7|-2.7|0.1209
72606442|NCT00676403|144740428|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|6.4||||0.2791||95.0|-5.3|18.0|||ANCOVA|||Bodily Pain: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.||18.0|-5.3|0.2791
72606443|NCT00676403|144740428|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|11.2||||0.0644||95.0|-0.7|23.0|||ANCOVA|||Bodily Pain: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.||23.0|-0.7|0.0644
72606444|NCT00676403|144740428|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.3||||0.7544||95.0|-9.5|6.9|||ANCOVA|||General Health: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.||6.9|-9.5|0.7544
72606445|NCT00676403|144740428|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.6||||0.5142||95.0|-10.3|5.2|||ANCOVA|||General Health: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.||5.2|-10.3|0.5142
72606446|NCT00676403|144740428|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.0||||0.8158||95.0|-7.4|9.4|||ANCOVA|||General Health: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.||9.4|-7.4|0.8158
72606447|NCT00676403|144740428|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.9||||0.4599||95.0|-10.8|4.9|||ANCOVA|||General Health: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.||4.9|-10.8|0.4599
72606448|NCT00676403|144740428|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.7||||0.8636||95.0|-8.7|7.3|||ANCOVA|||General Health: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.||7.3|-8.7|0.8636
72606449|NCT00676403|144740428|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.7||||0.5281||95.0|-7.8|15.1|||ANCOVA|||Vitality: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.||15.1|-7.8|0.5281
72606450|NCT00676403|144740428|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.5||||0.6566||95.0|-8.5|13.5|||ANCOVA|||Vitality: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.||13.5|-8.5|0.6566
72606451|NCT00676403|144740428|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|11.1||||0.0677||95.0|-0.8|23.0|||ANCOVA|||Vitality: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.||23.0|-0.8|0.0677
72606452|NCT00676403|144740428|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.3||||0.4443||95.0|-6.8|15.4|||ANCOVA|||Vitality: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.||15.4|-6.8|0.4443
72606453|NCT00676403|144740428|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|6.5||||0.2543||95.0|-4.7|17.7|||ANCOVA|||Vitality: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.||17.7|-4.7|0.2543
72606454|NCT00676403|144740428|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.4||||0.9416||95.0|-11.0|11.9|||ANCOVA|||Social Functioning: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.||11.9|-11.0|0.9416
72606455|NCT00676403|144740428|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.1||||0.5824||95.0|-14.1|7.9|||ANCOVA|||Social Functioning: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.||7.9|-14.1|0.5824
72416676|NCT02161133|144344113|SUPERIORITY||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|1.62||0.712|TWO_SIDED||||||Mixed Models Analysis|||||||0.712
72324736|NCT00269113|144172806|SUPERIORITY_OR_OTHER||Difference in percentage of participants|17.4||||0.0009|TWO_SIDED|95.0|6.4|28.4|||Fisher Exact|||||28.4|6.4|0.0009
72324737|NCT00269113|144172807|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Log Rank|||||||<0.0001
72324738|NCT00269113|144172808|SUPERIORITY_OR_OTHER|||||||0.0127|||||||Log Rank|||||||0.0127
72324739|NCT00269113|144172809|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Log Rank|||||||<0.0001
72324740|NCT00269113|144172810|SUPERIORITY_OR_OTHER|||||||0.0186|||||||Log Rank|||||||0.0186
72324741|NCT00269113|144172811|SUPERIORITY_OR_OTHER|||||||0.0002|||||||Log Rank|||||||0.0002
72324742|NCT00269113|144172812|SUPERIORITY_OR_OTHER|||||||0.0017|||||||Log Rank|||||||0.0017
72324743|NCT00755807|144172820|SUPERIORITY_OR_OTHER|||||||0.001||95.0||||The a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|Mixed model repeated measures (MMRM):Change from Baseline=Baseline+Treatment+Investigator+Week+Treatment\*Week+Baseline\*Week,participant random effect.||Null hypothesis: no difference between duloxetine and placebo on pain severity reduction as measured by weekly mean of the daily 24-hour average pain scores in participants assessed at 6 weeks. Sample size is determined using 2-sided t-test with significance level of 0.05, and 5% of randomized participants without post-baseline data due to very early discontinuation. With 119 participants per arm, study has approximately 80% power to detect an effect size of 0.375 on treatment group difference.||||0.001
72324744|NCT00755807|144172821|SUPERIORITY_OR_OTHER|||||||0.027||95.0||||P-value is for the 30% Reduction (LOCF). P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|Fisher Exact|||||||0.027
72324745|NCT00755807|144172821|SUPERIORITY_OR_OTHER|||||||0.246||95.0||||P-value is for 50% Reduction (LOCF). P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|Fisher Exact|||||||0.246
72324746|NCT00755807|144172821|SUPERIORITY_OR_OTHER|||||||0.024||95.0||||P-value is for the 30% Reduction (BOCF). P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|Fisher Exact|||||||0.024
72606456|NCT00676403|144740428|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.4||||0.5668||95.0|-15.3|8.4|||ANCOVA|||Social Functioning: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.||8.4|-15.3|0.5668
72606457|NCT00676403|144740428|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.6||||0.7769||95.0|-9.6|12.8|||ANCOVA|||Social Functioning: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.||12.8|-9.6|0.7769
72606458|NCT00676403|144740428|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|7.8||||0.1753||95.0|-3.5|19.1|||ANCOVA|||Social Functioning: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.||19.1|-3.5|0.1753
72606459|NCT00676403|144740428|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|8.7||||0.1508||95.0|-3.2|20.7|||ANCOVA|||Role-Emotional: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.||20.7|-3.2|0.1508
72606460|NCT00676403|144740428|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|9.9||||0.0916||95.0|-1.6|21.4|||ANCOVA|||Role-Emotional: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.||21.4|-1.6|0.0916
72606461|NCT00676403|144740428|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.1||||0.6222||95.0|-9.2|15.4|||ANCOVA|||Role-Emotional: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.||15.4|-9.2|0.6222
72606462|NCT00676403|144740428|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|10.2||||0.085||95.0|-1.4|21.8|||ANCOVA|||Role-Emotional: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.||21.8|-1.4|0.0850
72606463|NCT00676403|144740428|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|14.8||||0.0154||95.0|2.9|26.7|||ANCOVA|||Role-Emotional: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.||26.7|2.9|0.0154
72606464|NCT00676403|144740428|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.8||||0.7201||95.0|-11.9|8.2|||ANCOVA|||Mental Health: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.||8.2|-11.9|0.7201
72606465|NCT00676403|144740428|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.7||||0.8875||95.0|-9.1|10.5|||ANCOVA|||Mental Health: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.||10.5|-9.1|0.8875
72606466|NCT00676403|144740428|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.7||||0.3735||95.0|-5.7|15.1|||ANCOVA|||Mental Health: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.||15.1|-5.7|0.3735
72606467|NCT00676403|144740428|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.9||||0.8621||95.0|-8.9|10.6|||ANCOVA|||Mental Health: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.||10.6|-8.9|0.8621
72416677|NCT02161133|144344114|SUPERIORITY||Mean Difference (Final Values)|-6.18|STANDARD_ERROR_OF_MEAN|2.48||0.013|TWO_SIDED||||||Mixed Models Analysis|||||||0.013
72606468|NCT00676403|144740428|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|7.9||||0.1203||95.0|-2.1|17.8|||ANCOVA|||Mental Health: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.||17.8|-2.1|0.1203
72606469|NCT00676403|144740428|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.8||||0.4966||95.0|-5.4|11.0|||ANCOVA|||Summary Physical Score: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.||11.0|-5.4|0.4966
72606470|NCT00676403|144740428|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.2||||0.5776||95.0|-5.6|10.1|||ANCOVA|||Summary Physical Score: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.||10.1|-5.6|0.5776
72606471|NCT00676403|144740428|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.7||||0.3955||95.0|-4.9|12.3|||ANCOVA|||Summary Physical Score: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.||12.3|-4.9|0.3955
72606472|NCT00676403|144740428|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.0||||0.7994||95.0|-6.9|9.0|||ANCOVA|||Summary Physical Score: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.||9.0|-6.9|0.7994
72606473|NCT00676403|144740428|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.2||||0.2073||95.0|-2.9|13.2|||ANCOVA|||Summary Physical Score: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.||13.2|-2.9|0.2073
72606474|NCT00676403|144740428|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.2||||0.5148||95.0|-6.4|12.8|||ANCOVA|||Summary Emotional Score: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.||12.8|-6.4|0.5148
72606475|NCT00676403|144740428|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.0||||0.5255||95.0|-6.3|12.2|||ANCOVA|||Summary Emotional Score: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.||12.2|-6.3|0.5255
72606476|NCT00676403|144740428|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.4||||0.3793||95.0|-5.5|14.4|||ANCOVA|||Summary Emotional Score: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.||14.4|-5.5|0.3793
72606477|NCT00676403|144740428|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.8||||0.312||95.0|-4.5|14.1|||ANCOVA|||Summary Emotional Score: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.||14.1|-4.5|0.3120
72606478|NCT00676403|144740428|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|9.7||||0.0442||95.0|0.3|19.2|||ANCOVA|||Summary Emotional Score: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.||19.2|0.3|0.0442
72606479|NCT00676403|144740429|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4452||95.0|||||Cochran-Mantel-Haenszel|||CHM test for difference; p-value was adjusted for geographic region at each visit.||||0.4452
72606480|NCT00676403|144740429|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4342||95.0|||||Cochran-Mantel-Haenszel|||CHM test for difference; p-value was adjusted for geographic region at each visit.||||0.4342
72606481|NCT00676403|144740429|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0942||95.0|||||Cochran-Mantel-Haenszel|||CHM test for difference; p-value was adjusted for geographic region at each visit.||||0.0942
72606482|NCT00676403|144740429|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1873||95.0|||||Cochran-Mantel-Haenszel|||CHM test for difference; p-value was adjusted for geographic region at each visit.||||0.1873
72606483|NCT00676403|144740429|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4709||95.0|||||Cochran-Mantel-Haenszel|||CHM test for difference; p-value was adjusted for geographic region at each visit.||||0.4709
72606484|NCT01746862|144740430|SUPERIORITY_OR_OTHER||Least Squares (LS) Mean Difference|3.47|||<|0.0001|TWO_SIDED|95.0|2.17|4.78|||ANCOVA|Analysis was performed using analysis of covariance (ANCOVA) with baseline age and baseline height as the covariates.||||4.78|2.17|<0.0001
72606485|NCT06058390|144740470|OTHER||Geometric mean ratio|1.02|||||TWO_SIDED|90.0|0.91|1.14|||||Geometric mean is adjusted for covariates: randomized groups (Arms 1 and 2 of this endpoint), injection site (arm, thigh and abdomen) as categorical covariates and log transformed Baseline weight as continuous covariate.|Analysis was performed on the natural logarithms using a fixed-effects model.||1.14|0.91|
72606486|NCT06058390|144740471|OTHER||Geometric mean ratio|1.05|||||TWO_SIDED|90.0|0.96|1.15|||||Geometric mean is adjusted for covariates: randomized groups (Arms 1 and 2 of this endpoint), injection site (arm, thigh and abdomen) as categorical covariates and log transformed Baseline weight as continuous covariate.|Analysis was performed on the natural logarithms using a fixed-effects model.||1.15|0.96|
72606487|NCT06058390|144740472|OTHER||Geometric mean ratio|1.02|||||TWO_SIDED|90.0|0.88|1.18|||||Geometric mean is adjusted for covariates: randomized groups (Arms 1 and 2 of this endpoint), injection site (arm, thigh and abdomen) as categorical covariates and log transformed baseline weight as continuous covariate.|Analysis was performed on the natural logarithms using a fixed-effects model.||1.18|0.88|
72606488|NCT06058390|144740473|OTHER||Geometric mean ratio|0.98|||||TWO_SIDED|90.0|0.88|1.09|||||Geometric mean is adjusted for covariates: randomized groups (Arms 1 and 2 of this endpoint), injection site (arm, thigh and abdomen) as categorical covariates and log transformed Baseline weight as continuous covariate.|Analysis was performed on the natural logarithms using a fixed-effects model.||1.09|0.88|
72606489|NCT06058390|144740474|OTHER||Geometric mean ratio|0.99|||||TWO_SIDED|90.0|0.87|1.13|||||Geometric mean is adjusted for covariates: randomized groups (Arms 1 and 2 of this endpoint), injection site (arm, thigh and abdomen) as categorical covariates and log transformed Baseline weight as continuous covariate.|Analysis was performed on the natural logarithms using a fixed-effects model.||1.13|0.87|
72606490|NCT06058390|144740475|OTHER||Geometric mean ratio|0.97|||||TWO_SIDED|90.0|0.87|1.08|||||Geometric mean is adjusted for covariates: randomized groups (Arms 1 and 2 of this endpoint), injection site (arm, thigh and abdomen) as categorical covariates and log transformed Baseline weight as continuous covariate.|Analysis was performed on the natural logarithms using a fixed-effects model.||1.08|0.87|
72606491|NCT03361306|144740476|SUPERIORITY|Assuming the true VGPR+ rate is 40% under the null hypothesis, then this design will provide 90% power to detect a difference of 20% under the alternative hypothesis, assuming a one-sided alpha=0.10 significance level. For the originally planned enrollment of 40 subjects, if at least 21 subjects achieved VGPR or better to induction, the null hypothesis would be rejected.|Response Rate|0.467||||0.39|TWO_SIDED|95.0|0.213|0.734||This p-value is only based on partial enrollment on the study. As enrollment was halted early, this p-value is descriptive in nature and cannot determine the success/failure of the trial.|Fisher Exact||Confidence interval estimated using the Clopper Pearson method.|||0.734|0.213|0.390
72324747|NCT00755807|144172821|SUPERIORITY_OR_OTHER|||||||0.165||95.0||||P-value is for 50% Reduction (BOCF). P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|Fisher Exact|||||||0.165
72324748|NCT00755807|144172822|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.21||||0.121|TWO_SIDED|95.0|-0.06|0.49||P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|ANOVA|Analysis of Variance (ANOVA) Model: PGI improvement at Endpoint = Treatment + Investigator.|The mean difference is for placebo - duloxetine.|||0.49|-0.06|0.121
72324749|NCT00755807|144172823|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.66||||0.016|TWO_SIDED|95.0|0.12|1.2||P-value is for BPI Severity for Worst Pain score. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|ANCOVA|Model: Change from Baseline = Treatment + Investigator + Baseline Value.|The mean difference is for placebo - duloxetine.|||1.20|0.12|0.016
72324750|NCT00755807|144172823|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.48||||0.043|TWO_SIDED|95.0|0.02|0.95||P-value is for BPI Severity for Least Pain score. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|ANCOVA|Model: Change from Baseline = Treatment + Investigator + Baseline Value.|The mean difference is for placebo - duloxetine.|||0.95|0.02|0.043
72324751|NCT00755807|144172823|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.52||||0.03|TWO_SIDED|95.0|0.05|0.99||P-value is for BPI Severity for Average Pain score. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|ANCOVA|Model: Change from Baseline = Treatment + Investigator + Baseline Value.|The mean difference is for placebo - duloxetine.|||0.99|0.05|0.030
72416678|NCT02161133|144344115|SUPERIORITY||Mean Difference (Final Values)|12.23|STANDARD_ERROR_OF_MEAN|10.45||0.244|TWO_SIDED||||||Mixed Models Analysis|||||||0.244
72606492|NCT04073303|144740483|SUPERIORITY||Rate-Difference|49.0|||<|0.0001|TWO_SIDED|95.0|40.1|54.1|||Cochran-Mantel-Haenszel|||||54.1|40.1|<0.0001
72606493|NCT04073303|144740484|SUPERIORITY||Rate-Difference|71.2|||<|0.0001|TWO_SIDED|95.0|60.7|76.3|||Cochran-Mantel-Haenszel|||||76.3|60.7|<0.0001
72606494|NCT04073303|144740485|SUPERIORITY||Rate-Difference|56.7|||<|0.0001|TWO_SIDED|95.0|45.6|64.5|||Cochran-Mantel-Haenszel|||||64.5|45.6|<0.0001
72606495|NCT04073303|144740486|SUPERIORITY||Rate-Difference|49.7|||<|0.0001|TWO_SIDED|95.0|40.6|57.4|||Cochran-Mantel-Haenszel|||||57.4|40.6|<0.0001
72606496|NCT04073303|144740487|SUPERIORITY||Rate-Difference|70.5|||<|0.0001|TWO_SIDED|95.0|59.6|77.5|||Cochran-Mantel-Haenszel|||||77.5|59.6|<0.0001
72606497|NCT04073303|144740488|SUPERIORITY||LS Mean of Difference|-5.19|||<|0.0001|TWO_SIDED|95.0|-5.64|-4.75|||ANCOVA|||||-4.75|-5.64|<0.0001
72606498|NCT02131064|144740491|SUPERIORITY||Difference in tpCR rate|-11.71||||0.0126|TWO_SIDED|95.0|-20.95|-2.48||Threshold for significance at 5%|Cochran-Mantel-Haenszel Chi-Square|The Cochran-Mantel-Haenszel Chi-square test was used and stratified by local hormone receptor status and clinical stage at presentation.||95% CI for the difference in tPCR rates between treatment arms was calculated using normal approximation.||-2.48|-20.95|0.0126
72606499|NCT02131064|144740492|SUPERIORITY||Hazard Ratio (HR)|1.21||||0.7557|TWO_SIDED|95.0|0.37|3.96|||Cochran-Mantel-Haenszel Chi-Square Test|The Cochran-Mantel-Haenszel Chi-square test was used and stratified by local hormone receptor status and clinical stage at presentation.||||3.96|0.37|0.7557
72606500|NCT02131064|144740493|SUPERIORITY||Difference in BCS rate|-10.84||||0.0228|TWO_SIDED|95.0|-20.21|-1.47|||Cochran-Mantel-Haenszel Chi-Square|The Cochran-Mantel-Haenszel Chi-square test was used and stratified by local hormone receptor status and clinical stage at presentation.||95% CI for the difference in BCS rate between treatment arms was calculated using normal approximation.||-1.47|-20.21|0.0228
72606501|NCT02131064|144740494|SUPERIORITY||Hazard Ratio (HR)|2.61||||0.0027|TWO_SIDED|95.0|1.36|4.98|||Log Rank|The Log Rank was used and stratified by local hormone receptor status and clinical stage at presentation.||||4.98|1.36|0.0027
72606502|NCT02131064|144740495|SUPERIORITY||Hazard Ratio (HR)|1.11|||||TWO_SIDED|95.0|0.52|2.4||||||||2.40|0.52|
72606503|NCT02131064|144740498|SUPERIORITY||Difference in Deterioration|-24.58|||||TWO_SIDED|95.0|-33.98|-15.19||||||95% CI for the difference in clinically meaningful deterioration in GHS/QoL score between treatment arms was calculated using normal approximation.||-15.19|-33.98|
72606504|NCT02131064|144740499|SUPERIORITY||Hazard Ratio (HR)|0.6||||0.0001|TWO_SIDED|95.0|0.46|0.78|||Log Rank|Log Rank was used and stratified by local hormone receptor status and clinical stage at presentation.||Stratified cox proportional hazards regression model was used to estimate Hazard Ratio and CI. Stratification by hormonal receptor status and clinical stage at presentation (stratification factors).||0.78|0.46|0.0001
72606505|NCT02131064|144740510|SUPERIORITY||Difference in Deterioration|-16.63|||||TWO_SIDED|95.0|-26.32|-6.94||||||This is the statistical analysis for cognitive functioning. 95% CI for the difference in clinically meaningful deterioration in function subscales between treatment arms was calculated using normal approximation.||-6.94|-26.32|
72606506|NCT02131064|144740510|SUPERIORITY||Difference in Deterioration|-32.54|||||TWO_SIDED|95.0|-41.74|-23.34||||||This is the statistical analysis for physical functioning. 95% CI for the difference in clinically meaningful deterioration in function subscales between treatment arms was calculated using normal approximation.||-23.34|-41.74|
72606507|NCT02131064|144740510|SUPERIORITY||Difference in Deterioration|-28.88|||||TWO_SIDED|95.0|-37.95|-19.8||||||This is the statistical analysis for role functioning. 95% CI for the difference in clinically meaningful deterioration in function subscales between treatment arms was calculated using normal approximation.||-19.80|-37.95|
72324752|NCT00755807|144172823|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.89||||0.001|TWO_SIDED|95.0|0.36|1.43||P-value is for BPI Severity for Pain Right Now score. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|ANCOVA|Model: Change from Baseline = Treatment + Investigator + Baseline Value.|The mean difference is for placebo - duloxetine.|||1.43|0.36|0.001
72606508|NCT00810069|144740524|SUPERIORITY_OR_OTHER|||||||0.213|TWO_SIDED|95.0||||P-value is for early intervention strategy versus delayed intervention strategy.|Kaplan-Meier Analysis|Kaplan-Meier analysis with Wilcoxon test to compare strategies.||Kaplan-Meier Estimates (weeks): analysis of early intervention versus delayed intervention strategies||||0.213
72606509|NCT00810069|144740525|SUPERIORITY_OR_OTHER||survival rate difference|0.02||||0.653|TWO_SIDED|95.0|-0.06|0.1||P-value is for comparison of early intervention versus delayed intervention as a function of survival rate over a 12 week period (Week 4 through Week 16).|Kaplan Meier analysis|P-value for comparison of rates is based on normal approximation using Greenwood's estimation for standard error.||Survival function estimated over a 12 week period (Week 4 through Week 16): analysis of early intervention versus delayed intervention strategies||0.10|-0.06|0.653
72606510|NCT00810069|144740526|SUPERIORITY_OR_OTHER|||||||0.947||95.0||||P-value is for early intervention strategy versus delayed intervention strategy.|Kaplan Meier analysis|Kaplan-Meier analysis with Wilcoxon test to compare strategies.||Analysis of early intervention strategy versus delayed intervention strategy||||0.947
72606511|NCT00810069|144740527|SUPERIORITY_OR_OTHER|||||||0.597||95.0||||P-value is for early intervention versus delayed intervention strategies.|Kaplan-Meier analysis|Kaplan-Meier analysis with Wilcoxon test to compare strategies||Analysis of early intervention strategy versus delayed intervention strategy||||0.597
72416679|NCT02161133|144344116|SUPERIORITY||Mean Difference (Final Values)|-3.71|STANDARD_ERROR_OF_MEAN|1.95||0.057|TWO_SIDED||||||Mixed Models Analysis|||||||0.057
72606512|NCT00810069|144740528|SUPERIORITY_OR_OTHER||LS Mean|-0.04|STANDARD_ERROR_OF_MEAN|0.09||0.624|TWO_SIDED|95.0|-0.22|0.13||P-value for Week 6: Analysis of early versus delayed intervention strategies LS Mean/Estimate|Mixed Models Analysis|Mixed models repeated measures with fixed effects for strategy, country, visit, strategy-by-visit interaction, baseline score and baseline-by visit||Repeated Measurements Analysis: Early Intervention versus Delayed Intervention Strategy at Week 6||0.13|-0.22|0.624
72606513|NCT00810069|144740528|SUPERIORITY_OR_OTHER||LS Mean|-0.11|STANDARD_ERROR_OF_MEAN|0.09||0.208|TWO_SIDED|95.0|-0.29|0.06||P-value for Week 8: Analysis of early versus delayed intervention strategies LS Mean/Estimate|Mixed Models Analysis|Mixed Models repeated measures with fixed effects for strategy, country, visit, strategy-by-visit interaction, baseline score and baseline-by-visit||Repeated Measurements Analysis: Early Intervention versus Delayed Intervention Strategy at Week 8||0.06|-0.29|0.208
72606514|NCT00810069|144740528|SUPERIORITY_OR_OTHER||LS Mean|-0.19|STANDARD_ERROR_OF_MEAN|0.09||0.044|TWO_SIDED|95.0|-0.37|0.0||P-value for Week 10: Analysis of early versus delayed intervention strategies LS Mean/Estimate|Mixed Models Analysis|Mixed models repeated measures with fixed effects for strategy, country, visit, strategy-by-visit interaction, baseline score and baseline-by-visit||Repeated Measurements Analysis: Early Intervention versus Delayed Intervention Strategy at Week 10||-0.00|-0.37|0.044
72606515|NCT00810069|144740528|SUPERIORITY_OR_OTHER||LS Mean|-0.16|STANDARD_ERROR_OF_MEAN|0.1||0.086|TWO_SIDED|95.0|-0.35|0.02||P-value for Week 12: Analysis of early versus delayed intervention strategies LS Mean/Estimate|Mixed Models Analysis|Mixed models repeated measures with fixed effects for strategy, country, visit, strategy-by-visit interactions, baseline score and baseline-by-visit||Repeated Measurements Analysis: Early Intervention versus Delayed Intervention Strategy at Week 12||0.02|-0.35|0.086
72606516|NCT00810069|144740528|SUPERIORITY_OR_OTHER||LS Mean|-0.13|STANDARD_ERROR_OF_MEAN|0.1||0.181|TWO_SIDED|95.0|-0.33|0.06||P-value for Week 14: Analysis of early versus delayed intervention strategies LS Mean/Estimate|Mixed Models Analysis|Mixed models repeated measures with fixed effects for strategy, country, visit, strategy-by-visit interaction, baseline score and baseline-by-visit||Repeated Measurements Analysis: Early Intervention versus Delayed Intervention Strategy at Week 14||0.06|-0.33|0.181
72606517|NCT00810069|144740528|SUPERIORITY_OR_OTHER||LS Mean|0.0|STANDARD_ERROR_OF_MEAN|0.1||0.994|TWO_SIDED|95.0|-0.2|0.2||P-value for Week 16: Analysis of early versus delayed intervention strategies LS Mean/Estimate|Mixed Models Analysis|Mixed models repeated measures with fixed effects for strategy, country, visit, strategy-by-visit interaction, baseline score and baseline-by-visit||Repeated Measurements Analysis: Early Intervention versus Delayed Intervention Strategy at Week 16||0.20|-0.20|0.994
72324753|NCT00755807|144172823|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.52||||0.083|TWO_SIDED|95.0|-0.07|1.11||P-value is for BPI Interference for General Activity score. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|ANCOVA|Model: Change from Baseline = Treatment + Investigator + Baseline Value.|The mean difference is for placebo - duloxetine.|||1.11|-0.07|0.083
72324754|NCT00755807|144172823|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.66||||0.034|TWO_SIDED|95.0|0.05|1.27||P-value is for BPI Interference for Mood score. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|ANCOVA|Model: Change from Baseline = Treatment + Investigator + Baseline Value.|The mean difference is for placebo - duloxetine.|||1.27|0.05|0.034
72324755|NCT00755807|144172823|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.55||||0.089|TWO_SIDED|95.0|-0.08|1.19||P-value is for BPI Interference for Walking Ability score. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|ANCOVA|Model: Change from Baseline = Treatment + Investigator + Baseline Value.|The mean difference is for placebo - duloxetine.|||1.19|-0.08|0.089
72416680|NCT02161133|144344117|SUPERIORITY||Mean Difference (Final Values)|-1.37|STANDARD_ERROR_OF_MEAN|1.57||0.382|TWO_SIDED||||||Mixed Models Analysis|||||||0.382
72416681|NCT02161133|144344118|SUPERIORITY||Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.14||0.703|TWO_SIDED||||||Mixed Models Analysis|||||||0.703
72416682|NCT02161133|144344119|SUPERIORITY||Mean Difference (Final Values)|-1.88|STANDARD_ERROR_OF_MEAN|1.36||0.168|TWO_SIDED||||||Mixed Models Analysis|||||||0.168
72416683|NCT02161133|144344120|SUPERIORITY||Mean Difference (Final Values)|-7.28|STANDARD_ERROR_OF_MEAN|2.93||0.013|TWO_SIDED||||||Mixed Models Analysis|||||||0.013
72416684|NCT03945188|144344128|SUPERIORITY||Risk Difference (RD)|19.75|||<|0.001|TWO_SIDED|95.0|12.88|26.63|||Cochran-Mantel-Haenszel|||||26.63|12.88|<0.001
72606518|NCT00810069|144740529|SUPERIORITY_OR_OTHER||LS Mean|-0.62|STANDARD_ERROR_OF_MEAN|0.19||0.001|TWO_SIDED|95.0|-0.98|-0.25||P-value for Week 6: Analysis of early versus delayed intervention strategies LS Mean/Estimate|Mixed Models Analysis|Mixed models repeated measures with fixed effects for strategy, country, visit, strategy-by-visit interaction, baseline score and baseline-by visit||Repeated Measurements Analysis: Early Intervention versus Delayed Intervention Strategy at Week 6||-0.25|-0.98|0.001
72606519|NCT00810069|144740529|SUPERIORITY_OR_OTHER||LS Mean|-0.5|STANDARD_ERROR_OF_MEAN|0.19||0.01|TWO_SIDED|95.0|-0.87|-0.12||P-value for Week 8: Analysis of early versus delayed intervention strategies LS Mean/Estimate|Mixed Models Analysis|Mixed models repeated measures with fixed effects for strategy, country, visit, strategy-by-visit interaction, baseline score and baseline-by-visit||Repeated Measurements Analysis: Early Intervention versus Delayed Intervention Strategy at Week 8||-0.12|-0.87|0.010
72606520|NCT00810069|144740529|SUPERIORITY_OR_OTHER||LS Mean|-0.15|STANDARD_ERROR_OF_MEAN|0.2||0.445|TWO_SIDED|95.0|-0.55|0.24||P-value for Week 10: analysis of early versus delayed intervention strategies LS Mean/Estimate|Mixed Models Analysis|Mixed models repeated measures with fixed effects for strategy, country, visit, strategy-by-visit interaction, baseline score and baseline-by-visit||Repeated Measurements Analysis: Early Intervention versus Delayed Intervention Strategy at Week 10||0.24|-0.55|0.445
72606521|NCT00810069|144740529|SUPERIORITY_OR_OTHER||LS Mean|-0.29|STANDARD_ERROR_OF_MEAN|0.21||0.169|TWO_SIDED|95.0|-0.71|0.12||P-value for Week 12: Analysis of early versus delayed intervention strategies LS Mean/Estimate|Mixed Models Analysis|Mixed models repeated measures with fixed effects for strategy, country, visit, strategy-by-visit interaction, baseline score and baseline-by-visit||Repeated Measurements Analysis: Early Intervention versus Delayed Intervention Strategy at Week 12||0.12|-0.71|0.169
72606522|NCT00810069|144740529|SUPERIORITY_OR_OTHER||LS Mean|-0.19|STANDARD_ERROR_OF_MEAN|0.23||0.393|TWO_SIDED|95.0|-0.63|0.25||P-value for Week 14: Analysis of early versus delayed intervention strategies LS Mean/Estimate|Mixed Models Analysis|Mixed models repeated measures with fixed effects for strategy, country, visit, strategy-by-visit interaction, baseline score and baseline-by-visit||Repeated Measurements Analysis: Early Intervention versus Delayed Intervention Strategy at Week 14||0.25|-0.63|0.393
72606523|NCT00810069|144740529|SUPERIORITY_OR_OTHER||LS Mean|-0.15|STANDARD_ERROR_OF_MEAN|0.23||0.51|TWO_SIDED|95.0|-0.61|0.3||P-value for Week 16: Analysis of early versus delayed intervention strategies LS Mean/Estimate|Mixed Models Analysis|Mixed models repeated measures with fixed effects for strategy, country, visit, strategy-by-visit interaction, baseline scores and baseline-by-visit||Repeated Measurements Analysis: Early Intervention versus Delayed Intervention Strategy at Week 16||0.30|-0.61|0.510
72606524|NCT00810069|144740530|SUPERIORITY_OR_OTHER||LS Mean|0.14|STANDARD_ERROR_OF_MEAN|0.17||0.401|TWO_SIDED|95.0|-0.19|0.47||P-value for Week 8: Analysis of early intervention versus delayed intervention strategies LS Mean/Estimate|Mixed Models Analysis|Mixed models repeated measures with fixed effects for strategy, country, visit, strategy-by-visit interaction, baseline score and baseline-by-visit||Repeated Measurements Analysis: Early Intervention versus Delayed Intervention Strategy at Week 8||0.47|-0.19|0.401
72606525|NCT00810069|144740530|SUPERIORITY_OR_OTHER||LS Mean|0.09|STANDARD_ERROR_OF_MEAN|0.19||0.618|TWO_SIDED|95.0|-0.27|0.46||P-value for Week 12: Analysis of early intervention versus delayed intervention strategies LS Mean/Estimate|Mixed Models Analysis|Mixed models repeated measures with fixed effects for strategy, country, visit, strategy-by-visit interaction, baseline score and baseline-by-visit||Repeated Measurements Analysis: Early Intervention versus Delayed Intervention Strategy at Week 12||0.46|-0.27|0.618
72606526|NCT00810069|144740530|SUPERIORITY_OR_OTHER||LS Mean|-0.04|STANDARD_ERROR_OF_MEAN|0.2||0.856|TWO_SIDED|95.0|-0.43|0.36||P-value for Week 16: Analysis of early intervention versus delayed intervention strategies LS Mean/Estimate|Mixed Models Analysis|Mixed models repeated measures with fixed effects for strategy, country, visit, strategy-by-visit interaction, baseline score and baseline-by-visit||Repeated Measurements Analysis: Early Intervention versus Delayed Intervention Strategy at Week 16||0.36|-0.43|0.856
72606527|NCT00810069|144740531|SUPERIORITY_OR_OTHER||LS Mean|-0.05|STANDARD_ERROR_OF_MEAN|0.02||0.021|TWO_SIDED|95.0|-0.1|-0.01||P-value for Week 8: Analysis of early versus delayed intervention LS Mean/Estimate|Mixed Models Analysis|Mixed models repeated measures with fixed effects for strategy, country, visit, strategy-by-visit interaction, baseline score and baseline-by-visit||Repeated Measurements Analysis: Early Intervention versus Delayed Intervention Strategy at Week 8||-0.01|-0.10|0.021
72606528|NCT00810069|144740531|SUPERIORITY_OR_OTHER||LS Mean|-0.04|STANDARD_ERROR_OF_MEAN|0.02||0.071|TWO_SIDED|95.0|-0.09|0.0||P-value for Week 12: Analysis of early versus delayed intervention strategies LS Mean/Estimate|Mixed Models Analysis|Mixed models repeated measures with fixed effects for strategy, country, visit, strategy-by-visit interaction, baseline score and baseline-by-visit||Repeated Measurements Analysis: Early Intervention versus Delayed Intervention Strategy at Week 12||0.00|-0.09|0.071
72324756|NCT00755807|144172823|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.33||||0.291|TWO_SIDED|95.0|-0.28|0.93||P-value is for BPI Interference for Normal Work score. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|ANCOVA|Model: Change from Baseline = Treatment + Investigator + Baseline Value.|The mean difference is for placebo - duloxetine.|||0.93|-0.28|0.291
72416685|NCT03945188|144344129|SUPERIORITY||Risk Difference (RD)|25.39|||<|0.001|TWO_SIDED|95.0|18.42|32.36|||Cochran-Mantel-Haenszel|||||32.36|18.42|<0.001
72416686|NCT03945188|144344130|SUPERIORITY||Risk Difference (RD)|21.18|||<|0.001|TWO_SIDED|95.0|13.03|29.32|||Cochran-Mantel-Haenszel|||||29.32|13.03|<0.001
72416687|NCT03945188|144344131|SUPERIORITY||Risk Difference (RD)|26.69|||<|0.001|TWO_SIDED|95.0|18.99|34.39|||Cochran-Mantel-Haenszel|||||34.39|18.99|<0.001
72416688|NCT03945188|144344132|SUPERIORITY||Risk Difference (RD)|24.55|||<|0.001|TWO_SIDED|95.0|15.46|33.63|||Cochran-Mantel-Haenszel|||||33.63|15.46|<0.001
72416689|NCT03945188|144344133|SUPERIORITY||Risk Difference (RD)|24.89|||<|0.001|TWO_SIDED|95.0|16.17|33.6|||Cochran-Mantel-Haenszel|||||33.60|16.17|<0.001
72416690|NCT03945188|144344134|SUPERIORITY||Risk Difference (RD)|16.88|||<|0.001|TWO_SIDED|95.0|10.78|22.98|||Cochran-Mantel-Haenszel|||||22.98|10.78|<0.001
72324757|NCT00755807|144172823|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.5||||0.077|TWO_SIDED|95.0|-0.06|1.05||P-value is for BPI Interference for Relations With Others score. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|ANCOVA|Model: Change from Baseline = Treatment + Investigator + Baseline Value.|The mean difference is for placebo - duloxetine.|||1.05|-0.06|0.077
72324758|NCT00755807|144172823|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.41||||0.148|TWO_SIDED|95.0|-0.15|0.97||P-value is for BPI Interference for Sleep score. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|ANCOVA|Model: Change from Baseline = Treatment + Investigator + Baseline Value.|The mean difference is for placebo - duloxetine.|||0.97|-0.15|0.148
72324759|NCT00755807|144172823|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.17||||0.582|TWO_SIDED|95.0|-0.45|0.79||P-value is for BPI Interference for Enjoyment Of Life score. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|ANCOVA|Model: Change from Baseline = Treatment + Investigator + Baseline Value.|The mean difference is for placebo - duloxetine.|||0.79|-0.45|0.582
72324760|NCT00755807|144172823|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.45||||0.067|TWO_SIDED|95.0|-0.03|0.94||P-value is for BPI Mean Interference score. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|ANCOVA|Model: Change from Baseline = Treatment + Investigator + Baseline Value.|The mean difference is for placebo - duloxetine.|||0.94|-0.03|0.067
72324761|NCT00755807|144172824|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.23||||0.041|TWO_SIDED|95.0|0.01|0.45||P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|ANCOVA|Model: Change from Baseline = Treatment + Investigator + Baseline Value.|The mean difference is for placebo - duloxetine.|||0.45|0.01|0.041
72324762|NCT00755807|144172825|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0||||0.5|TWO_SIDED|95.0|-3.9|1.91||P-value is for treatment comparison of change from baseline on MSQOL Physical Health Composite Section score. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|ANCOVA|Model: Change from Baseline = Treatment + Investigator + Baseline Value.|The mean difference is for placebo - duloxetine.|||1.91|-3.90|0.500
72324763|NCT00755807|144172825|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.22||||0.512|TWO_SIDED|95.0|-4.87|2.44||P-value is for treatment comparison of change from baseline on MSQOL Mental Health Composite Section score. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|ANCOVA|Model: Change from Baseline = Treatment + Investigator + Baseline Value.|The mean difference is for placebo - duloxetine.|||2.44|-4.87|0.512
72324764|NCT00755807|144172825|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.69||||0.72|TWO_SIDED|95.0|-4.51|3.12||P-value is for treatment comparison of change from baseline on MSQOL Physical Health Subsection score. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|ANCOVA|Model: Change from Baseline = Treatment + Investigator + Baseline Value.|The mean difference is for placebo - duloxetine.|||3.12|-4.51|0.720
72324765|NCT00755807|144172825|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.06||||0.973|TWO_SIDED|95.0|-3.58|3.46||P-value is for treatment comparison of change from baseline on MSQOL Health Perceptions Subsection score. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|ANCOVA|Model: Change from Baseline = Treatment + Investigator + Baseline Value.|The mean difference is for placebo - duloxetine.|||3.46|-3.58|0.973
72324766|NCT00755807|144172825|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02||||0.991|TWO_SIDED|95.0|-4.07|4.02||P-value is for treatment comparison of change from baseline on MSQOL Energy Subsection score. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|ANCOVA|Model: Change from Baseline = Treatment + Investigator + Baseline Value.|The mean difference is for placebo - duloxetine.|||4.02|-4.07|0.991
72606529|NCT00810069|144740531|SUPERIORITY_OR_OTHER||LS Mean|0.01|STANDARD_ERROR_OF_MEAN|0.03||0.792|TWO_SIDED|95.0|-0.05|0.06||P-value for Week 16: Analysis of early versus delayed intervention strategies LS Mean/Estimate|Mixed Models Analysis|Mixed models repeated measures with fixed effects for strategy, country, visit, strategy-by-visit interaction, baseline score and baseline-by-visit||Repeated Measurements Analysis: Early Intervention versus Delayed Intervention Strategy at Week 16||0.06|-0.05|0.792
72606530|NCT00810069|144740532|SUPERIORITY_OR_OTHER||LS Mean|-0.37|STANDARD_ERROR_OF_MEAN|0.7||0.597|TWO_SIDED|95.0|-1.74|1.0||P-value for Week 8: Analysis of early versus delayed intervention strategies LS Mean/Estimate|Mixed Models Analysis|Mixed models repeated measures with fixed effects for strategy, country, visit, strategy-by-visit interaction, baseline score and baseline-by-visit||Repeated Measurements Analysis: Early Intervention versus Delayed Intervention Strategy at Week 8||1.00|-1.74|0.597
72324767|NCT00755807|144172825|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.14||||0.441|TWO_SIDED|95.0|-11.14|4.87||P-value is for treatment comparison of change from baseline on MSQOL Role Limitation Due to Physical Problems Subsection score. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|ANCOVA|Model: Change from Baseline = Treatment + Investigator + Baseline Value.|The mean difference is for placebo - duloxetine.|||4.87|-11.14|0.441
72606531|NCT00810069|144740532|SUPERIORITY_OR_OTHER||LS Mean|-0.68|STANDARD_ERROR_OF_MEAN|0.74||0.36|TWO_SIDED|95.0|-2.13|0.78||P-value for Week 12: Analysis for early versus delayed intervention strategies LS Mean/Estimate|Mixed Models Analysis|Mixed models repeated measures with fixed effects for strategy, country, visit, strategy-by-visit interaction, baseline score and baseline-by-visit||Repeated Measurements Analysis: Early Intervention versus Delayed Intervention Strategy at Week 12||0.78|-2.13|0.360
72606532|NCT00810069|144740532|SUPERIORITY_OR_OTHER||LS Mean|0.06|STANDARD_ERROR_OF_MEAN|0.81||0.937|TWO_SIDED|95.0|-1.52|1.65||P-value for Week 16: Analysis for early versus delayed intervention strategies LS Mean/Estimate|Mixed Models Analysis|Mixed models repeated measures with fixed effects for strategy, country, visit, strategy-by-visit interaction, baseline score and baseline-by-visit||Repeated Measurements Analysis: Early Intervention versus Delayed Intervention Strategy at Week 16||1.65|-1.52|0.937
72606533|NCT00810069|144740533|SUPERIORITY_OR_OTHER|||||||0.075||95.0||||P-value is for early intervention strategy versus delayed intervention strategy.|Kaplan-Meier analysis|Kaplan-Meier analysis with Wilcoxon test to compare strategies||Kaplan-Meier estimates (weeks): analysis of early intervention versus delayed intervention strategies||||0.075
72606534|NCT00810069|144740534|SUPERIORITY_OR_OTHER||Survival rate difference|-0.07||||0.116|TWO_SIDED|95.0|-0.16|0.02||P-value is for comparison of early intervention versus delayed intervention as a function of survival rate over a 12 week period (Week 4 through Week 16).|Kaplan-Meier analysis|P-value for comparison of rates is based on normal approximation using Greenwood's estimation for standard error.||Survival function estimated over a 12 week period (Week 4 through Week 16): analysis of early intervention versus delayed intervention strategies||0.02|-0.16|0.116
72606535|NCT03675360|144740542|SUPERIORITY||Mean Difference (Net)|-0.23|||<|0.05|TWO_SIDED|95.0|-0.32|-0.14|||linear mixed effects model|||||-0.14|-0.32|<0.05
72606536|NCT03675360|144740543|SUPERIORITY||Mean Difference (Net)|-10.3|||<|0.05|TWO_SIDED|95.0|-15.6|-4.9|||linear mixed effects model|||||-4.9|-15.6|<0.05
72606537|NCT03675360|144740544|SUPERIORITY||Mean Difference (Net)|-3.2|||<|0.05|TWO_SIDED|95.0|-7.3|0.9|||linear mixed effects model|||||0.9|-7.3|<0.05
72606538|NCT03675360|144740545|SUPERIORITY||Median Difference (Final Values)|-0.13|||<|0.05|TWO_SIDED|95.0|-0.31|0.05|||linear mixed effects model|||||0.05|-0.31|<0.05
72606539|NCT03675360|144740546|SUPERIORITY||Mean Difference (Net)|-5.9|||<|0.05|TWO_SIDED|95.0|-7.4|-4.4|||linear mixed effects model|||||-4.4|-7.4|<0.05
72606540|NCT03675360|144740547|SUPERIORITY||Mean Difference (Net)|-6.2|||<|0.05|TWO_SIDED|95.0|-10.5|-2.0|||linear mixed effects model|||||-2.0|-10.5|<0.05
72606541|NCT03675360|144740548|SUPERIORITY||Mean Difference (Net)|-2.4|||<|0.05|TWO_SIDED|95.0|-3.7|-1.1|||linear mixed effects model|||||-1.1|-3.7|<0.05
72606542|NCT03675360|144740549|SUPERIORITY||Mean Difference (Net)|-2.6|||<|0.05|TWO_SIDED|95.0|-5.2|0.0|||linear mixed effects model|||||0|-5.2|<0.05
72606543|NCT03675360|144740550|SUPERIORITY||Mean Difference (Net)|-4.7|||<|0.05|TWO_SIDED|95.0|-6.7|-2.6|||linear mixed effects model|||||-2.6|-6.7|<0.05
72606544|NCT03675360|144740551|SUPERIORITY||Mean Difference (Net)|-0.8|||<|0.05|TWO_SIDED|95.0|-1.8|0.3|||linear mixed effects model|||||0.3|-1.8|<0.05
72606545|NCT04767373|144740569|OTHER||Efficacy estimate|60.4|||<|0.001|TWO_SIDED|95.0|44.1|71.9|||Exact method|One-sided p-value was estimated using an exact method.|A modified Poisson regression with robust variance method was used to generate efficacy estimate (1- Relative Risk \[RR\]) \& 95% confidence interval (CI). The model included region, gestational age, and age at randomization as covariates.|||71.9|44.1|<0.001
72606546|NCT04767373|144740570|OTHER||Estimated Percentage Difference|-0.5|||||TWO_SIDED|95.0|-2.6|1.5|||||Estimated percentage difference beteween Clesrovimab 105 mg arm and placebo arm and associated 95% CI were calculated based on the Miettinen \& Nurminen method.|||1.5|-2.6|
72606547|NCT04767373|144740571|OTHER||Estimated Percentage Difference|-0.6|||||TWO_SIDED|95.0|-1.4|0.0|||||Estimated percentage difference between Clesrovimab 105 mg arm and placebo arm and associated 95% CI were calculated based on the Miettinen \& Nurminen method.|||-0.0|-1.4|
72606548|NCT04767373|144740572|OTHER||Estimated Percentage Difference|-1.8|||||TWO_SIDED|95.0|-5.0|1.2|||||Estimated percentage difference between Clesrovimab 105 mg arm and placebo arm and associated 95% CI were calculated based on the Miettinen \& Nurminen method.|||1.2|-5.0|
72606549|NCT04767373|144740573|OTHER||Estimated Percentage Difference|0.0|||||TWO_SIDED|95.0|-0.3|0.2|||||Estimated percentage difference between Clesrovimab 105 mg arm and placebo arm and associated 95% CI were calculated based on the Miettinen \& Nurminen method.|||0.2|-0.3|
72606550|NCT04767373|144740574|OTHER||Estimated Percentage Difference|0.1|||||TWO_SIDED|95.0|-0.4|0.5|||||Estimated percentage difference between Clesrovimab 105 mg arm and placebo arm and associated 95% CI were calculated based on the Miettinen \& Nurminen method.|||0.5|-0.4|
72606551|NCT04767373|144740577|OTHER||Efficacy estimate|84.2|||<|0.001|TWO_SIDED|95.0|66.6|92.6||One-sided p-value was estimated using an exact method.|Exact method||A modified Poisson regression with robust variance method was used to generate efficacy estimate (1- RR) \& 95% CI. The model included region, gestational age, and age at randomization as covariates.|||92.6|66.6|<0.001
72324768|NCT00755807|144172825|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.58||||0.108|TWO_SIDED|95.0|-7.94|0.79||P-value is for treatment comparison of change from baseline on MSQOL Pain Subsection score. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|ANCOVA|Model: Change from Baseline = Treatment + Investigator + Baseline Value.|The mean difference is for placebo - duloxetine.|||0.79|-7.94|0.108
72324769|NCT00755807|144172825|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.19||||0.948|TWO_SIDED|95.0|-5.77|5.39||P-value is for treatment comparison of change from baseline on MSQOL Sexual Function Subsection score. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|ANCOVA|Model: Change from Baseline = Treatment + Investigator + Baseline Value.|The mean difference is for placebo - duloxetine.|||5.39|-5.77|0.948
72324770|NCT00755807|144172825|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.96||||0.374|TWO_SIDED|95.0|-2.37|6.28||P-value is for treatment comparison of change from baseline on MSQOL Social Function Subsection score. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|ANCOVA|Model: Change from Baseline = Treatment + Investigator + Baseline Value.|The mean difference is for placebo - duloxetine.|||6.28|-2.37|0.374
72324771|NCT00755807|144172825|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.38||||0.867|TWO_SIDED|95.0|-4.1|4.87||P-value is for treatment comparison of change from baseline on MSQOL Health Distress Subsection score. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|ANCOVA|Model: Change from Baseline = Treatment + Investigator + Baseline Value.|The mean difference is for placebo - duloxetine.|||4.87|-4.10|0.867
72324772|NCT00755807|144172825|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.77||||0.306|TWO_SIDED|95.0|-1.63|5.17||P-value is for treatment comparison of change from baseline on MSQOL Overall Quality Of Life Subsection score. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|ANCOVA|Model: Change from Baseline = Treatment + Investigator + Baseline Value.|The mean difference is for placebo - duloxetine.|||5.17|-1.63|0.306
72416691|NCT03945188|144344135|SUPERIORITY||Risk Difference (RD)|18.39|||<|0.001|TWO_SIDED|95.0|11.39|25.39|||Cochran-Mantel-Haenszel|||||25.39|11.39|<0.001
72416692|NCT03945188|144344136|SUPERIORITY||Risk Difference (RD)|25.39|||<|0.001|TWO_SIDED|95.0|18.42|32.36|||Cochran-Mantel-Haenszel|||||32.36|18.42|<0.001
72416693|NCT03945188|144344137|SUPERIORITY||Risk Difference (RD)|15.84|||<|0.001|TWO_SIDED|95.0|10.66|21.03|||Cochran-Mantel-Haenszel|||||21.03|10.66|<0.001
72416694|NCT03945188|144344138|SUPERIORITY||Risk Difference (RD)|28.27|||<|0.001|TWO_SIDED|95.0|18.51|38.02|||Cochran-Mantel-Haenszel|||||38.02|18.51|<0.001
72606552|NCT04767373|144740578|OTHER||Efficacy estimate|59.5|||||TWO_SIDED|95.0|43.3|71.1|||||A modified Poisson regression with robust variance method was used to generate efficacy estimate (1- RR) \& 95% CI. The model included region, gestational age, and age at randomization as covariates.|||71.1|43.3|
72606553|NCT00593918|144740583|SUPERIORITY_OR_OTHER|||||||0.04||95.0|||||Mixed Models Analysis|A mixed random effects model was used both unadjusted and adjustment for relevant co-variates obtained from the literature.||||||0.04
72606554|NCT00593918|144740584|SUPERIORITY_OR_OTHER|||||||0.14||95.0||||Analysis was per protocol based on the number of children enrolled by genotype and completed nasal washes at first visit.|Mixed Models Analysis|A mixed random effects model was used both unadjusted and adjustment for relevant co-variates obtained from the literature.||||||0.14
72606555|NCT03421379|144740598|NON_INFERIORITY|The pre-defined non-inferiority margin is (10%)|Treatment Difference Wald's Method|0.0|||||TWO_SIDED|95.0|-1.47|1.47||||||||1.47|-1.47|
72606556|NCT02782741|144740604|NON_INFERIORITY|NI was demonstrated if the lower bound of the 2-sided 95% confidence interval (CI) for the difference of avalglucosidase alfa minus alglucosidase alfa was greater than (\>) -1.1.|LS mean difference|2.43|STANDARD_ERROR_OF_MEAN|1.29||0.0074|TWO_SIDED|95.0|-0.13|4.99|||mixed model for repeated measures|||Analysis performed using MMRM model with baseline FVC (% predicted, as continuous), sex, age (in years at baseline), treatment group, visit, interaction term between treatment group and visit as fixed effects.||4.99|-0.13|0.0074
72606557|NCT02782741|144740604|SUPERIORITY|A test for superiority of avalglucosidase alfa versus alglucosidase alfa was performed with an overall 5% level of significance.||||||0.0626||||||Threshold for significance at \<0.05 level.|mixed model for repeated measures|||Analysis performed using MMRM model with baseline FVC (% predicted, as continuous), sex, age (in years at baseline), treatment group, visit, interaction term between treatment group and visit as fixed effects.||||0.0626
72606558|NCT02782741|144740605|SUPERIORITY|Per the protocol-defined statistical test strategy for multiplicity adjustment, and since superiority was narrowly missed for FVC % predicted, superiority testing for the secondary outcome measure couldn't be performed.|LS mean difference|30.01|STANDARD_ERROR_OF_MEAN|14.43||0.0405|TWO_SIDED|95.0|1.33|58.69|||mixed model for repeated measures|||LS mean difference was derived from MMRM model with baseline FVC (% predicted) and baseline 6MWT (distance walked in meter), age (in years, at baseline), gender, treatment group, visit, and treatment-by-visit interaction as fixed effects.||58.69|1.33|0.0405
72606559|NCT02782741|144740606|OTHER|Per the protocol-defined statistical test strategy for multiplicity adjustment, and since superiority was narrowly missed for FVC % predicted, superiority testing for the secondary outcome measure couldn't be performed.|LS mean difference|3.13|STANDARD_ERROR_OF_MEAN|5.24||0.5522|TWO_SIDED|95.0|-7.31|13.57|||mixed model for repeated measures|||LS mean difference was derived from MMRM model for MIP % predicted adjusted for MIP % predicted at baseline, age (in years, at baseline), gender, treatment group, visit, and treatment-by-visit interaction as fixed effects.||13.57|-7.31|0.5522
72606560|NCT02782741|144740607|OTHER|Per the protocol-defined statistical test strategy for multiplicity adjustment, and since superiority was narrowly missed for FVC % predicted, superiority testing for the secondary outcome measure couldn't be performed.|LS mean difference|-1.94|STANDARD_ERROR_OF_MEAN|5.64||0.7321|TWO_SIDED|95.0|-13.17|9.29|||mixed model for repeated measures|||LS mean difference was derived from MMRM model for MEP % predicted adjusted for MEP % predicted at baseline, age (in years, at baseline), gender, treatment group, visit, and treatment-by-visit interaction as fixed effects.||9.29|-13.17|0.7321
72606561|NCT02782741|144740608|OTHER|Per the protocol-defined statistical test strategy for multiplicity adjustment, and since superiority was narrowly missed for FVC % predicted, superiority testing for the secondary outcome measure couldn't be performed.|LS mean difference|106.97|STANDARD_ERROR_OF_MEAN|67.17||0.115|TWO_SIDED|95.0|-26.56|240.5|||mixed model for repeated measures|||LS mean difference was derived from MMRM model for HHD lower extremity muscle strength composite score adjusted for summary HHD lower extremity score at baseline, baseline FVC (% predicted), age (in years, at baseline), gender, treatment group, visit, and treatment-by-visit interaction as fixed effects.||240.50|-26.56|0.1150
72606562|NCT02782741|144740609|OTHER|No formal testing of additional secondary endpoint of QMFT.|LS mean difference|2.08|STANDARD_ERROR_OF_MEAN|0.94||0.0288|TWO_SIDED|95.0|0.22|3.95||Nominal p-value.|mixed model for repeated measures|||LS mean difference was derived from MMRM models adjust for total QMFT score at baseline, baseline FVC (% predicted), age (in years, at baseline), gender, treatment group, visit, and treatment-by-visit interaction as fixed effects.||3.95|0.22|0.0288
72606563|NCT02782741|144740610|OTHER|No formal testing of additional secondary endpoint of SF-12.|Score difference|0.77|STANDARD_ERROR_OF_MEAN|1.46||0.5996|TWO_SIDED|95.0|-2.13|3.67|||mixed model for repeated measures|||The MMRM models adjust for baseline score (PCS), baseline FVC (% predicted), age (in years, at baseline), gender, treatment group, visit, and treatment-by-visit interaction as fixed effects.||3.67|-2.13|0.5996
72606564|NCT02782741|144740610|OTHER|No formal testing of additional secondary endpoint of SF-12.|Score difference|2.12|STANDARD_ERROR_OF_MEAN|1.8||0.2427|TWO_SIDED|95.0|-1.46|5.69|||mixed model for repeated measures|||The MMRM models adjust for baseline score (MCS), baseline FVC (% predicted), age (in years, at baseline), gender, treatment group, visit, and treatment-by-visit interaction as fixed effects.||5.69|-1.46|0.2427
72606565|NCT02155985|144740667|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.4||||0.7|TWO_SIDED|95.0|-5.5|8.8||While there are co-primary comparisons, due to the pilot nature of the study, no adjustment to the 0.05 type I error was made.|t-test, 2 sided||Mean difference is the percent difference in mean fold changes = ((300 mg mean fold change / placebo mean fold change) - 1) \* 100.|Paired differences between the two aspirin arms and placebo were estimated in a single linear regression model using linear combinations of the estimated means.||8.8|-5.5|0.70
72606566|NCT02155985|144740667|SUPERIORITY_OR_OTHER||Mean Difference (Net)|5.5||||0.14|TWO_SIDED|95.0|-1.7|13.3||While there are co-primary comparisons, due to the pilot nature of the study, no adjustment to the 0.05 type I error was made.|t-test, 2 sided||Mean difference is the percent difference in mean fold changes = ((100 mg mean fold change / placebo mean fold change) - 1) \* 100.|Paired differences between the two aspirin arms and placebo were estimated in a single linear regression model using linear combinations of the estimated means.||13.3|-1.7|0.14
72606567|NCT03110133|144740687|SUPERIORITY|||||||0.0488|||||||Chi-squared|||||||0.0488
72324773|NCT00755807|144172825|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6||||0.733|TWO_SIDED|95.0|-4.08|2.88||P-value is for treatment comparison of change from baseline on MSQOL Emotional Well-being Subsection score. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|ANCOVA|Model: Change from Baseline = Treatment + Investigator + Baseline Value.|The mean difference is for placebo - duloxetine.|||2.88|-4.08|0.733
72324774|NCT00755807|144172825|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.9||||0.283|TWO_SIDED|95.0|-13.88|4.08||P-value is for treatment comparison of change from baseline on MSQOL Role Limitation Due to Emotional Problems score. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|ANCOVA|Model: Change from Baseline = Treatment + Investigator + Baseline Value.|The mean difference is for placebo - duloxetine.|||4.08|-13.88|0.283
72416695|NCT03945188|144344139|SUPERIORITY||Risk Difference (RD)|24.93|||<|0.001|TWO_SIDED|95.0|15.79|34.07|||Cochran-Mantel-Haenszel|||||34.07|15.79|<0.001
72606568|NCT03110133|144740690|SUPERIORITY|||||||0.0347|||||||Chi-squared|||||||0.0347
72606569|NCT03574974|144740756|SUPERIORITY|||||||0.047|||||||t-test, 2 sided|||||||0.047
72606570|NCT03934216|144740765|SUPERIORITY||Odds Ratio (OR)|0.9||||0.5935|TWO_SIDED|95.0|0.3|2.4|||Stratified Cochran-Mantel-Haenszel|||||2.4|0.3|0.5935
72606571|NCT03934216|144740766|SUPERIORITY||Odds Ratio (OR)|1.2||||0.3051|TWO_SIDED|95.0|0.6|2.7|||Stratified Cochran-Mantel-Haenszel|||||2.7|0.6|0.3051
72606572|NCT03934216|144740767|SUPERIORITY||Odds Ratio (OR)|0.6||||0.8764|TWO_SIDED|95.0|0.3|1.4|||Stratified Cochran-Mantel-Haenszel|||||1.4|0.3|0.8764
72606573|NCT03934216|144740768|SUPERIORITY||Odds Ratio (OR)|1.4||||0.2235|TWO_SIDED|95.0|0.5|3.8|||Stratified Cochran-Mantel-Haenszel|||||3.8|0.5|0.2235
72606574|NCT00619827|144740769|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.97||||0.0003|TWO_SIDED|95.0|-2.99|-0.94|||ANCOVA|||||-0.94|-2.99|0.0003
72606575|NCT01063855|144740770|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|1.69|STANDARD_ERROR_OF_MEAN|0.43|<|0.001|TWO_SIDED|95.0|0.837|2.542||To properly adjust for multiplicity, a hierarchical (step-down) testing procedure with a priori ordered hypothesis was used to control the family-wise type I error was rate.|ANCOVA|ANCOVA model included treatment, PDE5I stratum, baseline Average IELT stratum, and region, as cofactors and baseline Average IELT as a covariate.|Estimates are based on two-stage sequential analysis using information fraction based weighted test statistics for PDE5I + Dapoxetine arm minus PDE5I + Placebo arm difference.|Null Hypothesis: No difference at Week 12 last postbaseline observations carried forward (LPOCF) Alternative Hypothesis:- Difference at Week 12 LPOCF \>0.||2.542|0.837|<0.001
72606576|NCT01063855|144740771|SUPERIORITY_OR_OTHER||Risk Difference (RD)|13.6||||0.001|TWO_SIDED|95.0|4.9|22.3||A hierarchical (step-down) testing procedure with a priori ordered hypothesis was used to control the family-wise type 1 error rate.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test, controlling for type of PDE5I stratum, baseline average IELT stratum, and region.|Risk Difference (RD) = PDE5I + Dapoxetine arm - PDE5I + placebo arm.|Null hypothesis: No difference at Week 12 last postbaseline observation carried forward (LPOCF). Alternative hypothesis: Difference at Week 12 LPOCF \> 0.||22.3|4.9|0.001
72606577|NCT01063855|144740772|SUPERIORITY_OR_OTHER||Risk Difference (RD)|9.2||||0.013|TWO_SIDED|95.0|1.1|17.2||A hierarchical (step-down) testing procedure with a priori ordered hypothesis was used to control the family-wise type 1 error rate.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel (CMH) test, controlling for type of PDE5I stratum, baseline average IELT stratum, and region.|Risk Difference (RD) = PDE5I + Dapoxetine arm - PDE5I + Placebo arm.|Null Hypothesis: No difference at Week 12 last postbaseline observation carried forward (LPOCF).||17.2|1.1|0.013
72606578|NCT01063855|144740773|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.78||||0.002|TWO_SIDED|95.0|1.204|2.619||To properly adjust for multiplicity, a hierarchical (step-down) testing procedure with a priori ordered hypothesis was used to control the family-wise type I error.|Regression, Logistic|Logistic Regression model included treatment, type of PDE5i stratum, baseline Average IELT stratum, and region, as factors.|Estimates are based on two-stage sequential analysis using information fraction based weighted test statistics for PDE5I + Dapoxetine arm over PDE5I + Placebo arm ratio.|Null Hypothesis: No difference at Week 12 last postbaseline observation carried forward (LPOCF) Alternative Hypothesis: PDE5I + Dapoxetine is superior to PDE5I + Placebo with respect to the outcome measure at Week 12 LPOCF.||2.619|1.204|0.002
72606579|NCT01063855|144740774|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.63||||0.007|TWO_SIDED|95.0|1.108|2.394||To properly adjust for multiplicity, a hierarchical (step-down) testing procedure with a priori ordered hypothesis was used to control the family-wise type I error was rate.|Regression, Logistic|Logistic Regression model included treatment, type of PDE5i stratum, baseline Average IELT stratum, and region, as factors.|Estimates are based on two-stage sequential analysis using information fraction based weighted test statistics for PDE5I + Dapoxetine arm over PDE5I + Placebo arm ratio.|Null Hypothesis: No difference at Week 12 last postbaseline observation carrried forward (LPOCF) Alternative Hypothesis:- PDE5I + Dapoxetine is superior to PDE5I + Placebo with respect to the outcome measure at Week 12 LPOCF.||2.394|1.108|0.007
72606580|NCT01063855|144740775|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.42|||<|0.001|TWO_SIDED|95.0|1.642|3.568||To properly adjust for multiplicity, a hierarchical (step-down) testing procedure with a priori ordered hypothesis was used to control the family-wise type I error was rate|Regression, Logistic|Logistic Regression model included treatment, type of PDE5i stratum, baseline Average IELT stratum, and region, as factors.|Estimates are based on two-stage sequential analysis using information fraction based weighted test statistics for PDE5I + Dapoxetine arm over PDE5I + Placebo arm ratio.|Null Hypothesis: No difference at Week 12 last postbaseline observation carried forward (LPOCF) Alternative Hypothesis:- PDE5I + Dapoxetine is superior to PDE5I + Placebo with respect to the outcome measure at Week 12.||3.568|1.642|<0.001
72416696|NCT03945188|144344140|SUPERIORITY||Risk Difference (RD)|26.16|||<|0.001|TWO_SIDED|95.0|17.48|34.84|||Cochran-Mantel-Haenszel|||||34.84|17.48|<0.001
72416697|NCT03945188|144344141|SUPERIORITY||Risk Difference (RD)|11.32|||<|0.001|TWO_SIDED|95.0|6.49|16.14|||Cochran-Mantel-Haenszel|||||16.14|6.49|<0.001
72416698|NCT03945188|144344142|SUPERIORITY||Risk Difference (RD)|10.23|||<|0.001|TWO_SIDED|95.0|4.73|15.73|||Cochran-Mantel-Haenszel|||||15.73|4.73|<0.001
72324775|NCT00755807|144172825|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.81||||0.664|TWO_SIDED|95.0|-4.49|2.86||P-value is for treatment comparison of change from baseline on MSQOL Cognitive Function Subsection score. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|ANCOVA|Model: Change from Baseline = Treatment + Investigator + Baseline Value.|The mean difference is for placebo - duloxetine.|||2.86|-4.49|0.664
72606581|NCT01063855|144740776|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.33|||>|0.05|TWO_SIDED|95.0|0.897|1.965||To properly adjust for multiplicity, a hierarchical (step-down) testing procedure with a priori ordered hypothesis was used to control the family-wise type I error was rate.|Regression, Logistic|Logistic Regression model included treatment, type of PDE5i stratum, baseline Average IELT stratum, and region, as factors.|Estimates are based on two-stage sequential analysis using information fraction based weighted test statistics for PDE5I + Dapoxetine arm over PDE5I + Placebo arm ratio.|Null Hypothesis: No difference at Week 12 last postbaseline observation carried forward (LPOCF) Alternative Hypothesis:- PDE5I + Dapoxetine is superior to PDE5I + Placebo with respect to the outcome measure at Week 12 LPOCF.||1.965|0.897|>0.05
72606582|NCT01063855|144740777|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.21|||<|0.001|TWO_SIDED|95.0|1.425|3.423||To properly adjust for multiplicity, a hierarchical (step-down) testing procedure with a priori ordered hypothesis was used to control the family-wise type I error was rate.|Regression, Logistic|Logistic Regression model included treatment, type of PDE5i stratum, baseline Average IELT stratum, and region, as factors.|Estimates are based on two-stage sequential analysis using information fraction based weighted test statistics for PDE5I + Dapoxetine arm over PDE5I + Placebo arm ratio.|Null Hypothesis: No difference at Week 12 last postbaseline observation carried forward (LPOCF) Alternative Hypothesis:- PDE5I + Dapoxetine is superior to PDE5I + Placebo with respect to the outcome measure at Week 12.||3.423|1.425|<0.001
72606583|NCT01854697|144740801|NON_INFERIORITY_OR_EQUIVALENCE|The primary endpoint assessment comparison was made within each of the 2 HCV genotypes (GT1a and GT1b). Within HCV GT1a, the 3-DAA + RBV and TPV/PR arms were compared. Within HCV GT1b, the 3-DAA and TPV/PR arms were compared. The test treatment arm was considered noninferior to the TPV/PR arm in the respective HCV subtype if the lower bound of the 2-sided 95% CI for the treatment arm difference was above the noninferiority margin of -10.5%.|Difference|14.7|||||TWO_SIDED|95.0|1.3|28.2|||||Difference (95% CI) from TPV/PR within GT1a. Calculated using the normal approximation to the binomial distribution.|||28.2|1.3|
72606584|NCT01854697|144740801|NON_INFERIORITY_OR_EQUIVALENCE|The primary endpoint assessment comparison was made within each of the 2 HCV genotypes (GT1a and GT1b). Within HCV GT1a, the 3-DAA + RBV and TPV/PR arms were compared. Within HCV GT1b, the 3-DAA and TPV/PR arms were compared. The test treatment arm was considered noninferior to the TPV/PR arm in the respective HCV subtype if the lower bound of the 2-sided 95% CI for the treatment arm difference was above the noninferiority margin of -10.5%.|Difference|19.5|||||TWO_SIDED|95.0|6.4|32.6|||||Difference (95% CI) from TPV/PR within GT1b. Calculated using the normal approximation to the binomial distribution.|||32.6|6.4|
72606585|NCT01854697|144740802|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|2.13|STANDARD_ERROR_OF_MEAN|2.28||0.351|TWO_SIDED|95.0|-2.39|6.65|||ANCOVA|ANCOVA model included baseline score and region as covariates and treatment arm as a factor.||||6.65|-2.39|0.351
72606586|NCT01854697|144740802|SUPERIORITY_OR_OTHER||Least Squares Mean of Difference|5.83|STANDARD_ERROR_OF_MEAN|1.84||0.002|TWO_SIDED|95.0|2.19|9.47|||ANCOVA|ANCOVA model included baseline score and region as covariates and treatment arm as a factor.||||9.47|2.19|0.002
72606587|NCT01854697|144740802|SUPERIORITY_OR_OTHER||Least Squares Mean of Difference|5.28|STANDARD_ERROR_OF_MEAN|1.65||0.002|TWO_SIDED|95.0|2.01|8.54|||ANCOVA|ANCOVA model included baseline score and region as covariates and treatment arm as a factor.||||8.54|2.01|0.002
72606588|NCT01854697|144740803|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|6.08|STANDARD_ERROR_OF_MEAN|1.69|<|0.001|TWO_SIDED|95.0|2.72|9.44|||ANCOVA|ANCOVA model included baseline score and region as covariates and treatment arm as a factor.||||9.44|2.72|<0.001
72606589|NCT01854697|144740803|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|6.2|STANDARD_ERROR_OF_MEAN|1.34|<|0.001|TWO_SIDED|95.0|3.55|8.85|||ANCOVA|ANCOVA model included baseline score and region as covariates and treatment arm as a factor.||||8.85|3.55|<0.001
72606590|NCT01854697|144740803|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|6.86|STANDARD_ERROR_OF_MEAN|1.27|<|0.001|TWO_SIDED|95.0|4.36|9.37|||ANCOVA|ANCOVA model included baseline score and region as covariates and treatment arm as a factor.||||9.37|4.36|<0.001
72606591|NCT01854697|144740804|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|7.2||||0.021|TWO_SIDED|95.0|1.4|38.0|||Regression, Logistic|Logistic regression model with treatment arm, baseline log10 HCV RNA level, and interleukin 28B (IL28B) genotype (CC versus non-CC) as predictors.||||38.0|1.4|0.021
72606592|NCT01854697|144740804|NON_INFERIORITY_OR_EQUIVALENCE|The test treatment arm was considered noninferior to the TPV/PR arm in the GT1b HCV subtype if the lower bound of the 2-sided 95% CI for the treatment arm difference was above the noninferiority margin of -10.5%.|Difference|20.8|||||TWO_SIDED|95.0|7.9|33.6|||||Difference (95% CI) from TPV/PR within GT1b. Calculated using the normal approximation to the binomial distribution.|||33.6|7.9|
72606593|NCT01854697|144740804|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|28.2||||0.002|TWO_SIDED|95.0|3.3|241.1|||Regression, Logistic|Calculated using logistic regression model with treatment arm, baseline log10 HCV RNA level, and IL28B genotype (CC versus non-CC) as predictors.||||241.1|3.3|0.002
72606594|NCT01854697|144740804|SUPERIORITY_OR_OTHER|||||||0.005|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratum-adjusted Cochran-Mantel-Haenszel after adjusting for IL28B genotype (CC or non-CC).||||||0.005
72324776|NCT00755807|144172825|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.98||||0.504|TWO_SIDED|95.0|-7.81|3.85||P-value is for treatment comparison of change from baseline on MSQOL Change in Health Subsection score. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|ANCOVA|Model: Change from Baseline = Treatment + Investigator + Baseline Value.|The mean difference is for placebo - duloxetine|||3.85|-7.81|0.504
72416699|NCT03945188|144344143|SUPERIORITY||Risk Difference (RD)|20.39|||<|0.001|TWO_SIDED|95.0|13.79|26.98|||Cochran-Mantel-Haenszel|||||26.98|13.79|<0.001
72416700|NCT03945188|144344144|SUPERIORITY||Risk Difference (RD)|9.16|||<|0.001|TWO_SIDED|95.0|4.93|13.38|||Cochran-Mantel-Haenszel|||||13.38|4.93|<0.001
72324777|NCT00755807|144172825|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.02||||0.27|TWO_SIDED|95.0|-11.18|3.14||P-value is for treatment comparison of change from baseline on MSQOL Satisfaction with Sexual Function Subsection score. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|ANCOVA|Model: Change from Baseline = Treatment + Investigator + Baseline Value.|The mean difference is for placebo - duloxetine|||3.14|-11.18|0.270
72324778|NCT00755807|144172826|SUPERIORITY_OR_OTHER|||||||0.119||95.0||||P-value is for treatment comparison in number of participants with CSSR-S Suicidal Ideation during first 6 weeks of acute treatment. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|Fisher Exact|||||||0.119
72324779|NCT00755807|144172826|SUPERIORITY_OR_OTHER|||||||0.494||95.0||||P-value is for treatment comparison in number of participants with CSSR-S Suicidal Behavior during first 6 weeks of acute treatment. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|Fisher Exact|||||||0.494
72324780|NCT00755807|144172826|SUPERIORITY_OR_OTHER|||||||0.494||95.0||||P-value is for treatment comparison in number of participants with CSSR-S Suicidal Acts during first 6 weeks of acute treatment. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|Fisher Exact|||||||0.494
72324781|NCT00755807|144172827|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|Mixed model repeated measures model:Change from Baseline=Baseline+Treatment+Investigator+Week+Treatment\*Week+Baseline\*Week; participant=random effect.||||||0.002
72606595|NCT01854697|144740807|NON_INFERIORITY_OR_EQUIVALENCE|The test treatment arm was considered noninferior to the TPV/PR arm in the GT1a HCV subtype if the lower bound of the 2-sided 95% CI for the treatment arm difference was above the noninferiority margin of -10.5%.|Difference|13.3|||||TWO_SIDED|95.0|-0.4|27.0|||||Difference (95% CI) from TPV/PR within GT1a. Calculated using the normal approximation to the binomial distribution.|||27.0|-0.4|
72324782|NCT00755807|144172828|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01||||0.662|TWO_SIDED|95.0|-0.06|0.04||P-value is for treatment comparison of change from baseline on BDI-II Question #9 score. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|ANCOVA|Model: Change from Baseline = Treatment + Investigator + Baseline Value.|The mean difference is for placebo - duloxetine.|||0.04|-0.06|0.662
72324783|NCT00755807|144172829|SUPERIORITY_OR_OTHER|||||||0.244||95.0||||This is the P-value for Discontinuation Due to Any Reason.|Fisher Exact|||||||0.244
72324784|NCT00755807|144172829|SUPERIORITY_OR_OTHER|||||||0.012||95.0||||This is the P-value for Adverse Event (AE).|Fisher Exact|||||||0.012
72324785|NCT00755807|144172829|SUPERIORITY_OR_OTHER|||||||0.622||95.0||||This is the P-value for Protocol Violation.|Fisher Exact|||||||0.622
72324786|NCT00755807|144172829|SUPERIORITY_OR_OTHER|||||||1||95.0||||This is the P-value for Subject Decision.|Fisher Exact|||||||1.00
72324787|NCT00755807|144172829|SUPERIORITY_OR_OTHER|||||||1||95.0||||This is the P-value for Lack of Efficacy.|Fisher Exact|||||||1.00
72324788|NCT00755807|144172829|SUPERIORITY_OR_OTHER|||||||1||95.0||||This is the P-value for Physician Decision.|Fisher Exact|||||||1.00
72416701|NCT03945188|144344145|SUPERIORITY||Risk Difference (RD)|6.49|||=|0.049|TWO_SIDED|95.0|0.02|12.95|||Cochran-Mantel-Haenszel|||Week 2||12.95|0.02|=0.049
72324789|NCT00755807|144172832|SUPERIORITY_OR_OTHER|||||||0.047||95.0||||P-value is for treatment comparison of change from baseline on Bicarbonate, HCO3. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|ANOVA|Model: Rank-transformed change from Baseline = Treatment + Investigator.||||||0.047
72324790|NCT00755807|144172833|SUPERIORITY_OR_OTHER|||||||0.033||95.0||||P-value is for treatment comparison of change from baseline on creatinine. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|ANOVA|Model: Rank-transformed change from Baseline = Treatment + Investigator.||||||0.033
72324791|NCT00755807|144172834|SUPERIORITY_OR_OTHER|||||||0.034||95.0||||P-value is for treatment comparison of change from baseline on platelet count. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|ANOVA|Model: Rank-transformed change from baseline = Treatment + Investigator.||||||0.034
72324792|NCT00755807|144172835|SUPERIORITY_OR_OTHER|||||||0.007||95.0||||P-value is for treatment comparison of change from baseline on inorganic phosphorus. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|ANOVA|Model: Rank-transformed change from Baseline = Treatment + Investigator.||||||0.007
72324793|NCT00755807|144172836|SUPERIORITY_OR_OTHER|||||||0.025||95.0||||P-value is for treatment comparison of change from baseline on uric acid. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|ANOVA|Model: Rank-transformed change from Baseline = Treatment + Investigator.||||||0.025
72324794|NCT00755807|144172837|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.86||||0.322|TWO_SIDED|95.0|-2.55|0.84||P-value is for treatment comparison of change from baseline on diastolic blood pressure. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|ANCOVA|Model: Change from Baseline = Treatment + Investigator + Baseline Value.|The mean difference is for placebo - duloxetine.|||0.84|-2.55|0.322
72324795|NCT00755807|144172837|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4||||0.787|TWO_SIDED|95.0|-3.32|2.52||P-value is for treatment comparison of change from baseline on systolic blood pressure. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|ANCOVA|Model: Change from Baseline = Treatment + Investigator + Baseline Value.|The mean difference is for placebo - duloxetine.|||2.52|-3.32|0.787
72324796|NCT00755807|144172838|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.55||||0.16|TWO_SIDED|95.0|-3.7|0.61||P-value is for treatment comparison of change from baseline on pulse rate. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|ANCOVA|Model: Change from Baseline = Treatment + Investigator + Baseline Value.|The mean difference is for placebo - duloxetine.|||0.61|-3.70|0.160
72416702|NCT03945188|144344145|SUPERIORITY||Risk Difference (RD)|15.03|||<|0.001|TWO_SIDED|95.0|7.32|22.74|||Cochran-Mantel-Haenszel|||Week 4||22.74|7.32|<0.001
72416703|NCT03945188|144344145|SUPERIORITY||Risk Difference (RD)|16.85|||<|0.001|TWO_SIDED|95.0|8.06|25.63|||Cochran-Mantel-Haenszel|||Week 8||25.63|8.06|<0.001
72324797|NCT00755807|144172839|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.77||||0.003|TWO_SIDED|95.0|0.27|1.26||P-value is for treatment comparison of change from baseline on weight. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|ANCOVA|Model: Change from Baseline = Treatment + Investigator + Baseline Value.|The mean difference is for placebo - duloxetine.|||1.26|0.27|0.003
72324798|NCT00755807|144172840|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|One-sample t-test of mean PGI-I score at 18 weeks for all participants who entered extension phase.||||||<0.001
72416704|NCT03945188|144344145|SUPERIORITY||Risk Difference (RD)|21.66|||<|0.001|TWO_SIDED|95.0|12.71|30.61|||Cochran-Mantel-Haenszel|||Week 16||30.61|12.71|<0.001
72324799|NCT00755807|144172841|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The P-value is for BPI-S for Worst Pain. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|One-sample t-test of mean change from extension phase baseline to endpoint on BPI-S for Worst Pain.||||||<0.001
72324800|NCT00755807|144172841|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The P-value is for BPI-S for Least Pain. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|One-sample t-test of mean change from extension phase baseline to endpoint on BPI-S for Least Pain score.||||||<0.001
72324801|NCT00755807|144172841|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The P-value is for BPI-S for Average Pain. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|One-sample t-test of mean change from extension phase baseline to endpoint on BPI-S for Average Pain score.||||||<0.001
72324802|NCT00755807|144172841|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|One-sample t-test of mean change from extension phase baseline to endpoint on BPI-S for Pain Right Now score.||||||<0.001
72324803|NCT00755807|144172841|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The P-value is for BPI-I for General Activity. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|One-sample t-test of mean change from extension phase baseline to endpoint on BPI-I for General Activity score.||||||<0.001
72324804|NCT00755807|144172841|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The P-value is for the BPI-I for Mood. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|One-sample t-test of mean change from extension phase baseline to endpoint on BPI-I for Mood score.||||||<0.001
72324805|NCT00755807|144172841|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The P-value is for the BPI-I for Walking Ability. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|One-sample t-test of mean change from extension phase baseline to endpoint on BPI-I for Walking Ability score.||||||<0.001
72416705|NCT03945188|144344145|SUPERIORITY||Risk Difference (RD)|23.74|||<|0.001|TWO_SIDED|95.0|14.98|32.51|||Cochran-Mantel-Haenszel|||Week 20||32.51|14.98|<0.001
72416706|NCT03945188|144344145|SUPERIORITY||Risk Difference (RD)|21.04|||<|0.001|TWO_SIDED|95.0|11.83|30.24|||Cochran-Mantel-Haenszel|||Week 24||30.24|11.83|<0.001
72416707|NCT03945188|144344145|SUPERIORITY||Risk Difference (RD)|25.82|||<|0.001|TWO_SIDED|95.0|17.08|34.56|||Cochran-Mantel-Haenszel|||Week 32||34.56|17.08|<0.001
72324806|NCT00755807|144172841|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The P-value is for the BPI-I for Normal Work. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|One-sample t-test of mean change from extension phase baseline to endpoint on BPI-I for Normal Work score.||||||<0.001
72324807|NCT00755807|144172841|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The P-value is for the BPI-I for Relations With Others. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|One-sample t-test of mean change from baseline to endpoint on BPI-I for Relations With Others score.||||||<0.001
72324808|NCT00755807|144172841|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The P-value is for the BPI-I for Sleep. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|One-sample t-test of mean change from extension phase baseline to endpoint on BPI-I for Sleep score.||||||<0.001
72324809|NCT00755807|144172841|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The P-value is for the BPI-I for Enjoyment of Life. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|One-sample t-test of mean change from extension phase baseline to endpoint on BPI-I for Enjoyment Of Life score.||||||<0.001
72324810|NCT00755807|144172841|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The P-value is for the BPI for Mean Interference Score. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|One-sample t-test of mean change from extension phase baseline to endpoint on BPI for Mean Interference score.||||||<0.001
72324811|NCT00755807|144172842|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|One-sample t-test of mean change from extension phase baseline to endpoint on CGI-S score for all participants who entered extension phase.||||||<0.001
72324812|NCT00755807|144172843|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|One-sample t-test of mean change from extension phase baseline to endpoint on MSQOL Physical Health Composite Section score.||||||0.002
72416708|NCT03945188|144344145|SUPERIORITY||Risk Difference (RD)|23.47|||<|0.001|TWO_SIDED|95.0|14.8|32.14|||Cochran-Mantel-Haenszel|||Week 40||32.14|14.80|<0.001
72416709|NCT03945188|144344145|SUPERIORITY||Risk Difference (RD)|26.37|||<|0.001|TWO_SIDED|95.0|17.92|34.82|||Cochran-Mantel-Haenszel|||Week 48||34.82|17.92|<0.001
72416710|NCT03945188|144344146|SUPERIORITY||Risk Difference (RD)|3.59|||=|0.057|TWO_SIDED|95.0|-0.11|7.3|||Cochran-Mantel-Haenszel|||Week 2||7.30|-0.11|=0.057
72416711|NCT03945188|144344146|SUPERIORITY||Risk Difference (RD)|6.88|||=|0.007|TWO_SIDED|95.0|1.86|11.9|||Cochran-Mantel-Haenszel|||Week 4||11.90|1.86|=0.007
72416712|NCT03945188|144344146|SUPERIORITY||Risk Difference (RD)|10.14|||=|0.001|TWO_SIDED|95.0|4.09|16.2|||Cochran-Mantel-Haenszel|||Week 8||16.20|4.09|=0.001
72416713|NCT03945188|144344146|SUPERIORITY||Risk Difference (RD)|16.36|||<|0.001|TWO_SIDED|95.0|9.89|22.83|||Cochran-Mantel-Haenszel|||Week 12||22.83|9.89|<0.001
72416714|NCT03945188|144344146|SUPERIORITY||Risk Difference (RD)|15.37|||<|0.001|TWO_SIDED|95.0|9.23|21.52|||Cochran-Mantel-Haenszel|||Week 16||21.52|9.23|<0.001
72416715|NCT03945188|144344146|SUPERIORITY||Risk Difference (RD)|17.8|||<|0.001|TWO_SIDED|95.0|11.85|23.75|||Cochran-Mantel-Haenszel|||Week 20||23.75|11.85|<0.001
72416716|NCT03945188|144344146|SUPERIORITY||Risk Difference (RD)|14.24|||<|0.001|TWO_SIDED|95.0|7.45|21.04|||Cochran-Mantel-Haenszel|||Week 24||21.04|7.45|<0.001
72416717|NCT03945188|144344146|SUPERIORITY||Risk Difference (RD)|20.03|||<|0.001|TWO_SIDED|95.0|14.25|25.81|||Cochran-Mantel-Haenszel|||Week 32||25.81|14.25|<0.001
72416718|NCT03945188|144344146|SUPERIORITY||Risk Difference (RD)|15.13|||<|0.001|TWO_SIDED|95.0|8.91|21.35|||Cochran-Mantel-Haenszel|||Week 40||21.35|8.91|<0.001
72324813|NCT00755807|144172843|SUPERIORITY_OR_OTHER|||||||0.054||95.0||||P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|One-sample t-test of mean change from extension phase baseline to endpoint on MSQOL Mental Health Composite Section score.||||||0.054
72324814|NCT00755807|144172843|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|One-sample t-test of mean change from extension phase baseline to endpoint on MSQOL Physical Health Subsection score.||||||0.002
72324815|NCT00755807|144172843|SUPERIORITY_OR_OTHER|||||||0.025||95.0||||P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|One-sample t-test of mean change from extension phase baseline to endpoint on MSQOL Health Perceptions Subsection score.||||||0.025
72324816|NCT00755807|144172843|SUPERIORITY_OR_OTHER|||||||0.008||95.0||||P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|One-sample t-test of mean change from extension phase baseline to endpoint on MSQOL Energy Subsection score.||||||0.008
72324817|NCT00755807|144172843|SUPERIORITY_OR_OTHER|||||||0.858||95.0||||P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|One-sample t-test of mean change from extension phase baseline to endpoint on MSQOL Role Limitation Due to Physical Problems Subsection score.||||||0.858
72324818|NCT00755807|144172843|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|One-sample t-test of mean change from extension phase baseline to endpoint on MSQOL Pain Subsection score.||||||<0.001
72324819|NCT00755807|144172843|SUPERIORITY_OR_OTHER|||||||0.637||95.0||||P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|One-sample t-test of mean change from extension phase baseline to endpoint on MSQOL Sexual Function Subsection score.||||||0.637
72324820|NCT00755807|144172843|SUPERIORITY_OR_OTHER|||||||0.051||95.0||||P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|One-sample t-test of mean change from extension phase baseline to endpoint on MSQOL Social Function Subsection score.||||||0.051
72324821|NCT00755807|144172843|SUPERIORITY_OR_OTHER|||||||0.27||95.0||||P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|One-sample t-test of mean change from extension phase baseline to endpoint on MSQOL Health Distress Subsection score.||||||0.270
72324822|NCT00755807|144172843|SUPERIORITY_OR_OTHER|||||||0.061||95.0||||P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|One-sample t-test of mean change from extension phase baseline to endpoint on MSQOL Overall Quality Of Life Subsection score.||||||0.061
72324823|NCT00755807|144172843|SUPERIORITY_OR_OTHER|||||||0.007||95.0||||P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|One-sample t-test of mean change from extension phase baseline to endpoint on MSQOL Emotional Well-being Subsection score.||||||0.007
72324824|NCT00755807|144172843|SUPERIORITY_OR_OTHER|||||||0.253||95.0||||P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|One-sample t-test of mean change from extension phase baseline to endpoint on MSQOL Role Limitation Due to Emotional Problems score.||||||0.253
72324825|NCT00755807|144172843|SUPERIORITY_OR_OTHER|||||||0.942||95.0||||P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|One-sample t-test of mean change from extension phase baseline to endpoint on MSQOL Cognitive Function Subsection score.||||||0.942
72324826|NCT00755807|144172843|SUPERIORITY_OR_OTHER|||||||0.016||95.0||||P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|One-sample t-test of mean change from extension phase baseline to endpoint on MSQOL Change in Health Subsection score.||||||0.016
72324827|NCT00755807|144172843|SUPERIORITY_OR_OTHER|||||||0.381||95.0||||P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|One-sample t-test of mean change from extension phase baseline to endpoint on MSQOL Satisfaction with Sexual Function Subsection score.||||||0.381
72324828|NCT00755807|144172845|SUPERIORITY_OR_OTHER|||||||0.524||95.0||||P-value is for test of mean change from extension phase baseline to endpoint (Week 7). P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|Mixed model repeated measures (MMRM) Model: Change from Baseline=Baseline+Investigator+Week+Baseline\*Week; participant was treated as random effect.||||||0.524
72324829|NCT00755807|144172845|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for test of mean change from extension phase baseline to endpoint (Week 8). P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|MMRM Model: Change from Baseline = Baseline + Investigator + Week + Baseline\* Week, where participant was treated as a random effect.||||||<0.001
72324830|NCT00755807|144172845|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for test of mean change from extension phase baseline to endpoint (Week 9). P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|MMRM Model: Change from Baseline = Baseline + Investigator + Week + Baseline\* Week, where participant was treated as a random effect.||||||<0.001
72324831|NCT00755807|144172845|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for test of mean change from extension phase baseline to endpoint (Week 10). P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|MMRM Model: Change from Baseline = Baseline + Investigator + Week + Baseline\* Week, where participant was treated as a random effect.||||||<0.001
72324832|NCT00755807|144172845|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for test of mean change from extension phase baseline to endpoint (Week 11). P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|MMRM Model: Change from Baseline = Baseline + Investigator + Week + Baseline\* Week, where participant was treated as a random effect.||||||<0.001
72606596|NCT01854697|144740807|NON_INFERIORITY_OR_EQUIVALENCE|The test treatment arm was considered noninferior to the TPV/PR arm in the GT1b HCV subtype if the lower bound of the 2-sided 95% CI for the treatment arm difference was above the noninferiority margin of -10.5%.|Difference|19.6|||||TWO_SIDED|95.0|6.5|32.7|||||Difference (95% CI) from TPV/PR within GT1b. Calculated using the normal approximation to the binomial distribution.|||32.7|6.5|
72606597|NCT01854697|144740807|NON_INFERIORITY_OR_EQUIVALENCE|The test treatment arm was considered noninferior to the TPV/PR arm in the GT1b HCV subtype if the lower bound of the 2-sided 95% CI for the treatment arm difference was above the noninferiority margin of -10.5%.|Difference|19.5|||||TWO_SIDED|95.0|6.4|32.6|||||Difference (95% CI) from TPV/PR within GT1b. Calculated using the normal approximation to the binomial distribution.|||32.6|6.4|
72606598|NCT04428385|144740821|SUPERIORITY||Risk Ratio (RR)|0.85|||||TWO_SIDED|95.0|0.34|2.16||||||||2.16|0.34|
72606599|NCT04428385|144740822|SUPERIORITY||Risk Ratio (RR)|0.92|||||TWO_SIDED|95.0|0.47|1.78||||||||1.78|0.47|
72606600|NCT04428385|144740823|SUPERIORITY||Risk Ratio (RR)|0.76|||||TWO_SIDED|95.0|0.36|1.62||||||||1.62|0.36|
72606601|NCT04428385|144740824|SUPERIORITY||Risk Ratio (RR)|0.67|||||TWO_SIDED|95.0|0.33|1.33||||||||1.33|0.33|
72606602|NCT04428385|144740825|SUPERIORITY||Risk Ratio (RR)|1.09|||||TWO_SIDED|95.0|0.62|1.9||||||||1.90|0.62|
72606603|NCT03677635|144740845|OTHER||Standardised Effect Size|0.32|||||TWO_SIDED|95.0|0.21|0.86|||Standardised Effect Size|||||.86|.21|
72606604|NCT03677635|144740846|OTHER|Cohen's d was reported.|Mean Difference (Final Values)|-0.05|||||TWO_SIDED|95.0|-0.59|0.48|||Standardised Effect Size|||||.48|-.59|
72606605|NCT02157519|144740861|SUPERIORITY||Odds Ratio (OR)|0.56||||0.186|TWO_SIDED|95.0|0.23|1.33||threshold p \<0.05|Regression, Logistic|Adjusted for baseline MMAS-4 scores (dichotomous) and change in perceived social support (MSPSS) from baseline to post-assessment||Analysis comparing the number of participants who self-reported adherence problems (i.e., dichotomous MMAS-4 scores) at post-assessment between groups adjusting for baseline self-reported adherence (i.e., dichotomous MMAS-4 scores) and change in perceived social support (MSPSS) from baseline to post-assessment.||1.33|0.23|0.186
72606606|NCT02157519|144740862|SUPERIORITY||Mean Difference (Final Values)|-2.34|STANDARD_ERROR_OF_MEAN|4.06||0.57|TWO_SIDED|95.0|-10.35|5.68||threshold p \< 0.05|Regression, Linear|Adjusted for change in perceived social support (MSPSS) from baseline to post-assessment||Analysis comparing the percentage of medication taken (as recorded by MEMS) from baseline to post-assessment between groups adjusting for change in perceived social support (MSPSS) from baseline to post-assessment.||5.68|-10.35|0.57
72324833|NCT00755807|144172845|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for test of mean change from extension phase baseline to endpoint (Week 12). P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|MMRM Model: Change from Baseline = Baseline + Investigator + Week + Baseline\* Week, where participant was treated as a random effect.||||||<0.001
72416719|NCT03945188|144344146|SUPERIORITY||Risk Difference (RD)|17.52|||<|0.001|TWO_SIDED|95.0|12.16|22.87|||Cochran-Mantel-Haenszel|||Week 48||22.87|12.16|<0.001
72606607|NCT02157519|144740863|SUPERIORITY||Mean Difference (Final Values)|0.11|STANDARD_ERROR_OF_MEAN|0.21||0.603|TWO_SIDED|95.0|-0.31|0.53||threshold p \<0.05|Regression, Linear|Adjusted for change in perceived social support (MSPSS) from baseline to post-assessment||Analysis comparing the change in symptom severity (MDASI-severity) from baseline to post-assessment between groups adjusting for change in perceived social support (MSPSS) from baseline to post-assessment.||0.53|-0.31|0.603
72606608|NCT02157519|144740863|SUPERIORITY||Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.33||0.982|TWO_SIDED|95.0|-0.64|0.65||threshold p \<0.05|Regression, Linear|Adjusted for change in perceived social support (MSPSS) from baseline to post-assessment||Analysis comparing the change in symptom interference (MDASI-interference) from baseline to post-assessment between groups adjusting for change in perceived social support (MSPSS) from baseline to post assessment.||0.65|-0.64|0.982
72324834|NCT00755807|144172845|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for test of mean change from extension phase baseline to endpoint (Week 13). P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|MMRM Model: Change from Baseline = Baseline + Investigator + Week + Baseline\* Week, where participant was treated as a random effect.||||||<0.001
72606609|NCT02157519|144740864|SUPERIORITY||Mean Difference (Final Values)|-2.42|STANDARD_ERROR_OF_MEAN|1.65||0.144|TWO_SIDED|95.0|-5.66|0.83||threshold p \< 0.05|Regression, Linear|Adjusted for change in perceived social support (MSPSS) from baseline to post-assessment||Analysis comparing the change in overall QOL (FACT-G) from baseline to post-assessment between groups adjusting for change in perceived social support (MSPSS) from baseline to post-assessment.||0.83|-5.66|0.144
72606610|NCT02157519|144740864|SUPERIORITY||Mean Difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|0.66||0.294|TWO_SIDED|95.0|-2.0|0.61||threshold p \<0.05|Regression, Linear|Adjusted for change in perceived social support (MSPSS) from baseline to post-assessment||Analysis comparing the change in physical QOL (FACT-Physical Well-Being) from baseline to post-assessment between groups adjusting for change in perceived social support (MSPSS) baseline from baseline to post-assessment.||0.61|-2.00|0.294
72324835|NCT00755807|144172845|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for test of mean change from extension phase baseline to endpoint (Week 14). P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|MMRM Model: Change from Baseline = Baseline + Investigator + Week + Baseline\* Week, where participant was treated as a random effect.||||||<0.001
72606611|NCT02157519|144740864|SUPERIORITY||Mean Difference (Final Values)|-1.67|STANDARD_ERROR_OF_MEAN|0.74||0.025|TWO_SIDED|95.0|-3.12|-0.21||threshold p \<0.05|Regression, Linear|Adjusted for change in perceived social support (MSPSS) from baseline to post-assessment||Analysis comparing the change in social QOL (FACT-Social Well-Being) from baseline to post-assessment between groups adjusting for change in perceived social support (MSPSS) from baseline to post-assessment.||-0.21|-3.12|0.025
72606612|NCT02157519|144740864|SUPERIORITY||Mean Difference (Final Values)|0.49|STANDARD_ERROR_OF_MEAN|0.58||0.392|TWO_SIDED|95.0|-0.64|1.63||threshold p \<0.05|Regression, Linear|Adjusted for change in perceived social support (MSPSS) from baseline to post-assessment||Analysis comparing the change in emotional QOL (FACT-Emotional Well-Being) from baseline to post-assessment between groups adjusting for change in perceived social support (MSPSS) from baseline to post-assessment.||1.63|-0.64|0.392
72416720|NCT03945188|144344146|SUPERIORITY||Risk Difference (RD)|19.86|||<|0.001|TWO_SIDED|95.0|13.75|25.98|||Cochran-Mantel-Haenszel|||Week 52||25.98|13.75|<0.001
72606613|NCT02157519|144740864|SUPERIORITY||Mean Difference (Final Values)|-0.75|STANDARD_ERROR_OF_MEAN|0.6||0.216|TWO_SIDED|95.0|-1.94|0.44||threshold p \<0.05|Regression, Linear|Adjusted for change in perceived social support (MSPSS) from baseline to post-assessment||Analysis comparing the change in functional QOL (FACT-Functional Well-Being) from baseline to post-assessment between groups adjusting for change in perceived social support (MSPSS) from baseline to post-assessment.||0.44|-1.94|0.216
72606614|NCT02157519|144740865|SUPERIORITY||Mean Difference (Final Values)|-0.38|STANDARD_ERROR_OF_MEAN|0.28||0.17|TWO_SIDED|95.0|-0.93|0.17||threshold p \< 0.05|Regression, Linear|Adjusted for change in perceived social support (MSPSS) from baseline to post assessment||Analysis comparing change in treatment satisfaction with clinician explanations (FACIT-TS-PS-Clinician Explanations) from baseline to post-assessment between groups adjusting for change in perceived social support (MSPSS) from baseline to post-assessment.||0.17|-0.93|0.170
72606615|NCT02157519|144740865|SUPERIORITY||Mean Difference (Final Values)|-0.35|STANDARD_ERROR_OF_MEAN|0.18||0.057|TWO_SIDED|95.0|-0.72|0.01||threshold p \< 0.05|Regression, Linear|Adjusted for change in perceived social support (MSPSS) from baseline to post assessment||Analysis comparing change in satisfaction with interpersonal treatment (FACIT-TS-PS Interpersonal Treatment) from baseline to post-assessment between groups adjusting for change in perceived social support (MSPSS) from baseline to post-assessment.||0.01|-0.72|0.057
72606616|NCT02157519|144740865|SUPERIORITY||Mean Difference (Final Values)|-0.97|STANDARD_ERROR_OF_MEAN|0.72||0.178|TWO_SIDED|95.0|-2.39|0.45||threshold p \< 0.05|Regression, Linear|Adjusted for change in perceived social support (MSPSS) from baseline to post-assessment||Analysis comparing change in treatment satisfaction with comprehensive care (FACIT-TS-PS Comprehensive Care) from baseline to post-assessment between groups adjusting for change in perceived social support (MSPSS) from baseline to post-assessment.||0.45|-2.39|0.178
72606617|NCT02157519|144740865|SUPERIORITY||Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|0.28||0.481|TWO_SIDED|95.0|-0.35|0.75||threshold p \< 0.05|Regression, Linear|Adjusted for change in perceived social support (MSPSS) from baseline to post-assessment||Analysis comparing change in treatment satisfaction with nursing care (FACIT-TS-PS Nursing Care) from baseline to post-assessment between groups adjusting for change in perceived social support (MSPSS) from baseline to post-assessment.||0.75|-0.35|0.481
72606618|NCT02157519|144740865|SUPERIORITY||Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.17||0.97|TWO_SIDED|95.0|-0.34|0.35||threshold p \< 0.05|Regression, Linear|Adjusted for change in perceived social support (MSPSS) from baseline to post-assessment||Analysis comparing change in treatment satisfaction with trust in clinicians (FACIT-TS-PS Trust in Clinicians) from baseline to post-assessment between groups adjusting for change in perceived social support (MSPSS) from baseline to post-assessment.||0.35|-0.34|0.970
72606619|NCT02157519|144740866|SUPERIORITY||Mean Difference (Final Values)|-0.03|STANDARD_ERROR_OF_MEAN|0.06||0.682|TWO_SIDED|95.0|-0.15|0.1||threshold p \< 0.05|Regression, Linear|Adjusted for change in perceived social support (MSPSS) from baseline to post-assessment||Analysis comparing the number of emergency department (ED) visits over the study period between groups adjusting for change in perceived social support (MSPSS) from baseline to post-assessment.||0.10|-0.15|0.682
72606620|NCT02157519|144740867|SUPERIORITY||Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.1||0.64|TWO_SIDED|95.0|-0.24|0.15||threshold p \< 0.05|Regression, Linear|Adjusted for change in perceived social support (MSPSS) from baseline to post-assessment||Analysis comparing the number of hospitalizations over they study period between groups adjusting for change in perceived social support (MSPSS) from baseline to post-assessment||0.15|-0.24|0.640
72606621|NCT01656395|144740868|SUPERIORITY||Mean Difference (Final Values)|0.022||||0.685|TWO_SIDED|95.0|-0.084|0.127|||cLDA model|||Difference in least squares (LS) means for average change from Baseline over Week 6 to Week 12 in FEV1: MK-1029 10 mg vs. Placebo. Constrained longitudinal data analysis (cLDA) model includes terms for visit as categorical variable, prior inhaled corticosteroid (ICS) use (Yes/No) and treatment by visit. Positive differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).||0.127|-0.084|0.685
72606622|NCT01656395|144740868|SUPERIORITY||Mean Difference (Final Values)|-0.04||||0.477|TWO_SIDED|95.0|-0.149|0.07|||cLDA model|||Difference in LS means for average change from Baseline over Week 6 to Week 12 in FEV1: MK-1029 30 mg vs. Placebo. cLDA model includes terms for visit as categorical variable, prior ICS use (Yes/No) and treatment by visit. Positive differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).||0.07|-0.149|0.477
72606623|NCT01656395|144740868|SUPERIORITY||Mean Difference (Final Values)|0.019||||0.733|TWO_SIDED|95.0|-0.092|0.13|||cLDA model|||Difference in LS means for average change from Baseline over Week 6 to Week 12 in FEV1: MK-1029 60 mg vs. Placebo. cLDA model includes terms for visit as categorical variable, prior ICS use (Yes/No) and treatment by visit. Positive differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).||0.13|-0.092|0.733
72606624|NCT01656395|144740868|SUPERIORITY||Mean Difference (Final Values)|-0.008||||0.89|TWO_SIDED|95.0|-0.115|0.1|||cLDA model|||Difference in LS means for average change from Baseline over Week 6 to Week 12 in FEV1: MK-1029 150 mg vs. Placebo. cLDA model includes terms for visit as categorical variable, prior ICS use (Yes/No) and treatment by visit. Positive differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).||0.1|-0.115|0.89
72416721|NCT03945188|144344147|SUPERIORITY||Risk Difference (RD)|4.83|||=|0.336|TWO_SIDED|95.0|-5.01|14.68|||Cochran-Mantel-Haenszel|||Week 2||14.68|-5.01|=0.336
72416722|NCT03945188|144344147|SUPERIORITY||Risk Difference (RD)|17.11|||<|0.001|TWO_SIDED|95.0|7.06|27.15|||Cochran-Mantel-Haenszel|||Week 4||27.15|7.06|<0.001
72324836|NCT00755807|144172845|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for test of mean change from extension phase baseline to endpoint (Week 15). P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|MMRM Model: Change from Baseline = Baseline + Investigator + Week + Baseline\* Week, where participant was treated as a random effect.||||||<0.001
72324837|NCT00755807|144172845|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for test of mean change from extension phase baseline to endpoint (Week 16). P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|MMRM Model: Change from Baseline = Baseline + Investigator + Week + Baseline\* Week, where participant was treated as a random effect.||||||<0.001
72324838|NCT00755807|144172845|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for test of mean change from extension phase baseline to endpoint (Week 17). P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|MMRM Model: Change from Baseline = Baseline + Investigator + Week + Baseline\* Week, where participant was treated as a random effect.||||||<0.001
72324839|NCT00755807|144172845|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for test of mean change from extension phase baseline to endpoint (Week 18). P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|MMRM Model: Change from Baseline = Baseline + Investigator + Week + Baseline\* Week, where participant was treated as a random effect.||||||<0.001
72324840|NCT00755807|144172846|SUPERIORITY_OR_OTHER|||||||0.706||95.0||||P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|1-sample t-test of mean change from extension phase baseline to endpoint on BDI-II Question #9 score for all participants who entered extension phase.||||||0.706
72324841|NCT00755807|144172850|SUPERIORITY_OR_OTHER|||||||0.035||95.0||||P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|Wilcoxon (Mann-Whitney)|Wilcoxon signed rank test of mean change from extension phase baseline to endpoint on monocytes.||||||0.035
72416723|NCT03945188|144344147|SUPERIORITY||Risk Difference (RD)|20.17|||<|0.001|TWO_SIDED|95.0|10.15|30.19|||Cochran-Mantel-Haenszel|||Week 8||30.19|10.15|<0.001
72416724|NCT03945188|144344147|SUPERIORITY||Risk Difference (RD)|23.44|||<|0.001|TWO_SIDED|95.0|13.45|33.43|||Cochran-Mantel-Haenszel|||Week 12||33.43|13.45|<0.001
72416725|NCT03945188|144344147|SUPERIORITY||Risk Difference (RD)|25.25|||<|0.001|TWO_SIDED|95.0|15.67|34.83|||Cochran-Mantel-Haenszel|||Week 16||34.83|15.67|<0.001
72324842|NCT00755807|144172851|SUPERIORITY_OR_OTHER|||||||0.042||95.0||||P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|Wilcoxon (Mann-Whitney)|Wilcoxon signed rank test of mean change from extension phase baseline to endpoint on sodium.||||||0.042
72324843|NCT00755807|144172852|SUPERIORITY_OR_OTHER|||||||0.036||95.0||||P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|Wilcoxon (Mann-Whitney)|Wilcoxon signed rank test of mean change from extension phase baseline to endpoint on total protein.||||||0.036
72324844|NCT00755807|144172853|SUPERIORITY_OR_OTHER|||||||0.32||95.0||||P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|One-sample t-test of mean change from extension phase baseline to endpoint on diastolic blood pressure.||||||0.320
72324845|NCT00755807|144172853|SUPERIORITY_OR_OTHER|||||||0.182||95.0||||P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|One-sample t-test of mean change from extension phase baseline to endpoint on systolic blood pressure.||||||0.182
72324846|NCT00755807|144172854|SUPERIORITY_OR_OTHER|||||||0.032||95.0||||P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|One-sample t-test of mean change from extension phase baseline to endpoint on pulse rate.||||||0.032
72416726|NCT03945188|144344147|SUPERIORITY||Risk Difference (RD)|29.2|||<|0.001|TWO_SIDED|95.0|19.77|38.64|||Cochran-Mantel-Haenszel|||Week 20||38.64|19.77|<0.001
72416727|NCT03945188|144344147|SUPERIORITY||Risk Difference (RD)|26.08|||<|0.001|TWO_SIDED|95.0|16.47|35.69|||Cochran-Mantel-Haenszel|||Week 24||35.69|16.47|<0.001
72416728|NCT03945188|144344147|SUPERIORITY||Risk Difference (RD)|28.68|||<|0.001|TWO_SIDED|95.0|19.35|38.02|||Cochran-Mantel-Haenszel|||Week 32||38.02|19.35|<0.001
72416729|NCT03945188|144344147|SUPERIORITY||Risk Difference (RD)|28.43|||<|0.001|TWO_SIDED|95.0|19.3|37.55|||Cochran-Mantel-Haenszel|||Week 40||37.55|19.30|<0.001
72416730|NCT03945188|144344147|SUPERIORITY||Risk Difference (RD)|29.59|||<|0.001|TWO_SIDED|95.0|20.55|38.64|||Cochran-Mantel-Haenszel|||Week 48||38.64|20.55|<0.001
72416731|NCT03945188|144344147|SUPERIORITY||Risk Difference (RD)|26.43|||<|0.001|TWO_SIDED|95.0|17.18|35.68|||Cochran-Mantel-Haenszel|||Week 52||35.68|17.18|<0.001
72416732|NCT03945188|144344148|SUPERIORITY||Risk Difference (RD)|5.93|||=|0.24|TWO_SIDED|95.0|-3.96|15.81|||Cochran-Mantel-Haenszel|||Week 2||15.81|-3.96|=0.240
72416733|NCT03945188|144344148|SUPERIORITY||Risk Difference (RD)|17.5|||<|0.001|TWO_SIDED|95.0|7.48|27.53|||Cochran-Mantel-Haenszel|||Week 4||27.53|7.48|<0.001
72416734|NCT03945188|144344148|SUPERIORITY||Risk Difference (RD)|20.93|||<|0.001|TWO_SIDED|95.0|10.92|30.94|||Cochran-Mantel-Haenszel|||Week 8||30.94|10.92|<0.001
72416735|NCT03945188|144344148|SUPERIORITY||Risk Difference (RD)|24.13|||<|0.001|TWO_SIDED|95.0|14.15|34.1|||Cochran-Mantel-Haenszel|||Week 12||34.10|14.15|<0.001
72416736|NCT03945188|144344148|SUPERIORITY||Risk Difference (RD)|24.51|||<|0.001|TWO_SIDED|95.0|14.89|34.13|||Cochran-Mantel-Haenszel|||Week 16||34.13|14.89|<0.001
72416737|NCT03945188|144344148|SUPERIORITY||Risk Difference (RD)|29.57|||<|0.001|TWO_SIDED|95.0|20.13|39.01|||Cochran-Mantel-Haenszel|||Week 20||39.01|20.13|<0.001
72416738|NCT03945188|144344148|SUPERIORITY||Risk Difference (RD)|26.45|||<|0.001|TWO_SIDED|95.0|16.88|36.02|||Cochran-Mantel-Haenszel|||Week 24||36.02|16.88|<0.001
72416739|NCT03945188|144344148|SUPERIORITY||Risk Difference (RD)|29.35|||<|0.001|TWO_SIDED|95.0|20.01|38.68|||Cochran-Mantel-Haenszel|||Week 32||38.68|20.01|<0.001
72416740|NCT03945188|144344148|SUPERIORITY||Risk Difference (RD)|28.83|||<|0.001|TWO_SIDED|95.0|19.71|37.95|||Cochran-Mantel-Haenszel|||Week 40||37.95|19.71|<0.001
72324847|NCT00755807|144172855|SUPERIORITY_OR_OTHER|||||||0.151||95.0||||P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|One-sample t-test of mean change from extension phase baseline to endpoint on weight.||||||0.151
72324848|NCT01714323|144172856|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.07|||>|0.05|TWO_SIDED|95.0|0.84|1.37|||Chi-squared|||Data from all three sites were combined after determining that outcomes did not vary by hospital using Breslow-Day tests. The proportion abstinent by treatment arm was assessed using chi-square test.||1.37|0.84|>0.05
72324849|NCT01714323|144172857|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Chi-squared|||||||>0.05
72324850|NCT01714323|144172858|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Chi-squared|||This compares at Month 1||||<0.001
72324851|NCT01714323|144172858|SUPERIORITY||||||<|0.01|||||||Chi-squared|||This is analysis for Month 3||||<0.01
72324852|NCT01714323|144172858|SUPERIORITY||||||<|0.09|||||||Chi-squared|||This is for Month 6||||<0.09
72324853|NCT01714323|144172860|SUPERIORITY_OR_OTHER||||||<|0.001||||||This is the p value for the comparison at each follow up point: 1 mo, 3 mo, and 6 mo.|Chi-squared|||||||<0.001
72324854|NCT01714323|144172861|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Chi-squared|||||||>0.05
72324855|NCT01714323|144172862|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Chi-squared|||||||>0.05
72324856|NCT03531814|144172866|OTHER|||||||0.006||||||The Greenhouse-Geisser correction was used because Mauchly's test of sphericity was significant. The reported p-value represents the probability of the differences in the averages of adherence assessment methods for cycles 1-4.|ANOVA|||||||0.006
72324857|NCT03531814|144172866|OTHER|||||||0.021||||||The Greenhouse-Geisser correction was used because Mauchly's test of sphericity was significant. The reported p-value represents the probability of the differences in the averages of adherence assessment methods for cycles 5-8.|ANOVA|||||||0.021
72324858|NCT03531814|144172866|OTHER|||||||0.034||||||The Greenhouse-Geisser correction was used because Mauchly's test of sphericity was significant. The reported p-value represents the probability of the differences in the averages of adherence assessment methods for cycles 9-12.|ANOVA|||||||.034
72324859|NCT03531814|144172866|OTHER|||||||0.04||||||The Greenhouse-Geisser correction was used because Mauchly's test of sphericity was significant. The reported p-value represents the probability of the differences in the averages of adherence assessment methods for cycles 13-18.|ANOVA|||||||.040
72324860|NCT03531814|144172867|OTHER||Spearman's correlation|-0.21||||0.536|TWO_SIDED|95.0|-0.729|0.463||The reported p-value represents the probability that the strength of the relationship is due to chance at cycles 1-4.|Spearman correlation (non-parametric)|||||0.463|-0.729|0.536
72324861|NCT03531814|144172867|OTHER||Spearman's correlation|0.134||||0.713|TWO_SIDED|95.0|-0.557|0.715||The reported p-value represents the probability that the strength of the relationship is due to chance at cycles 5-8.|Spearman correlation (non-parametric)|||||0.715|-0.557|.713
72324862|NCT03531814|144172867|OTHER||Spearman's correlation|0.095||||0.823|TWO_SIDED|95.0|-0.668|0.761||The reported p-value represents the probability that the strength of the relationship is due to chance at cycles 9-12.|Spearman correlation (non-parametric)|||||0.761|-0.668|.823
72324863|NCT03531814|144172867|OTHER||Spearman's correlation|0.333||||0.42|TWO_SIDED|95.0|-0.505|0.848||The reported p-value represents the probability that the strength of the relationship is due to chance at cycles 13-18.|Spearman correlation (non-parametric)|||||0.848|-0.505|.420
72324864|NCT03531814|144172868|OTHER||Spearman's correlation|-0.333||||0.317|TWO_SIDED|95.0|-0.785|0.352||The reported p-value represents the probability that the strength of the relationship is due to chance at cycles 1-4.|Spearman correlation (non-parametric)|||||0.352|-0.785|0.317
72324865|NCT03531814|144172868|OTHER||Spearman's correlation|-0.309||||0.385|TWO_SIDED|95.0|-0.794|0.416||The reported p-value represents the probability that the strength of the relationship is due to chance at cycles 5-8.|Spearman correlation (non-parametric)|||||0.416|-0.794|.385
72324866|NCT03531814|144172868|OTHER||Spearman's correlation|-0.259||||0.535|TWO_SIDED|95.0|-0.824|0.563||The reported p-value represents the probability that the strength of the relationship is due to chance at cycles 9-12.|Spearman correlation (non-parametric)|||||0.563|-0.824|.535
72324867|NCT03531814|144172868|OTHER||Spearman's correlation|-0.222||||0.597|TWO_SIDED|95.0|-0.811|0.589||The reported p-value represents the probability that the strength of the relationship is due to chance at cycles 13-18.|Spearman correlation (non-parametric)|||||0.589|-0.811|.597
72324868|NCT03531814|144172869|OTHER||Spearman's correlation|-0.215||||0.526|TWO_SIDED|95.0|-0.731|0.459||The reported p-value represents the probability that the strength of the relationship is due to chance at cycles 1-4.|Spearman correlation (non-parametric)|||||0.459|-0.731|0.526
72324869|NCT03531814|144172869|OTHER||Spearman's correlation|0.049||||0.894|TWO_SIDED|95.0|-0.613|0.67||The reported p-value represents the probability that the strength of the relationship is due to chance at cycles 5-8.|Spearman correlation (non-parametric)|||||0.670|-0.613|.894
72324870|NCT03531814|144172869|OTHER||Spearman's correlation|-0.048||||0.911|TWO_SIDED|95.0|-0.74|0.694||The reported p-value represents the probability that the strength of the relationship is due to chance at cycles 9-12|Spearman correlation (non-parametric)|||||0.694|-0.740|.911
72324871|NCT03531814|144172869|OTHER||Spearman's correlation|-0.167||||0.693|TWO_SIDED|95.0|-0.79|0.626||The reported p-value represents the probability that the strength of the relationship is due to chance at cycles 13-18|Spearman correlation (non-parametric)|||||0.626|-0.790|.693
72324872|NCT03531814|144172870|OTHER||Spearman's correlation|-0.607||||0.048|TWO_SIDED|95.0|-0.889|0.009||The reported p-value represents the probability that the strength of the relationship is due to chance at cycles 1-4.|Spearman correlation (non-parametric)|||||0.009|-0.889|0.048
72324873|NCT03531814|144172870|OTHER||Spearman's correlation|-0.658||||0.038|TWO_SIDED|95.0|-0.914|-0.027||The reported p-value represents the probability that the strength of the relationship is due to chance at cycles 5-8.|Spearman correlation (non-parametric)|||||-0.027|-0.914|0.038
72324874|NCT03531814|144172870|OTHER||Spearman's correlation|-0.708||||0.5|TWO_SIDED|95.0|-0.945|0.02||The reported p-value represents the probability that the strength of the relationship is due to chance at cycles 9-12.|Spearman correlation (non-parametric)|||||0.020|-0.945|0.50
72416741|NCT03945188|144344148|SUPERIORITY||Risk Difference (RD)|30.0|||<|0.001|TWO_SIDED|95.0|20.97|39.03|||Cochran-Mantel-Haenszel|||Week 48||39.03|20.97|<0.001
72416742|NCT03945188|144344148|SUPERIORITY||Risk Difference (RD)|26.84|||<|0.001|TWO_SIDED|95.0|17.6|36.07|||Cochran-Mantel-Haenszel|||Week 52||36.07|17.60|<0.001
72416743|NCT03945188|144344149|SUPERIORITY||Risk Difference (RD)|23.05|||<|0.001|TWO_SIDED|95.0|10.2|35.9|||Cochran-Mantel-Haenszel|||||35.90|10.20|<0.001
72324875|NCT03531814|144172870|OTHER||Spearman's correlation|-0.878||||0.004|TWO_SIDED|95.0|-0.979|-0.435||The reported p-value represents the probability that the strength of the relationship is due to chance at cycles 13-18.|Spearman correlation (non-parametric)|||||-0.435|-0.979|0.004
72324876|NCT03531814|144172871|OTHER||Spearman's correlation|0.293||||0.382|TWO_SIDED|95.0|-0.39|0.768||The reported p-value represents the probability that the strength of the relationship is due to chance at cycles 1-4.|Spearman correlation (non-parametric)|||||0.768|-0.390|0.382
72324877|NCT03531814|144172871|OTHER||Spearman's correlation|0.278||||0.436|TWO_SIDED|95.0|-0.444|0.781||The reported p-value represents the probability that the strength of the relationship is due to chance at cycles 5-8.|Spearman correlation (non-parametric)|||||0.781|-0.444|0.436
72324878|NCT03531814|144172871|OTHER||Spearman's correlation|0.229||||0.586|TWO_SIDED|95.0|-0.585|0.813||The reported p-value represents the probability that the strength of the relationship is due to chance at cycles 9-12.|Spearman correlation (non-parametric)|||||0.813|-0.585|0.586
72324879|NCT03531814|144172871|OTHER||Spearman's correlation|0.53||||0.177|TWO_SIDED|95.0|-0.302|0.904||The reported p-value represents the probability that the strength of the relationship is due to chance at cycles 13-18.|Spearman correlation (non-parametric)|||||0.904|-0.302|0.177
72324880|NCT03531814|144172873|OTHER||Spearman's correlation|-0.576||||0.063|TWO_SIDED|95.0|-0.879|0.056||The reported p-value represents the probability that the strength of the relationship is due to chance at cycles 1-4.|Spearman correlation (non-parametric)|||||0.056|-0.879|0.063
72324881|NCT03531814|144172873|OTHER||Spearman's correlation|-0.68||||0.031|TWO_SIDED|95.0|-0.92|-0.066||The reported p-value represents the probability that the strength of the relationship is due to chance at cycles 5-8.|Wilcoxon (Mann-Whitney)|||||-0.066|-0.920|0.031
72324882|NCT03531814|144172873|OTHER||Spearman's correlation|-0.835||||0.01|TWO_SIDED|95.0|-0.971|-0.292||The reported p-value represents the strength of the relationship between the variables at cycles 9-12.|Spearman correlation (non-parametric)|||||-0.292|-0.971|0.010
72324883|NCT03531814|144172873|OTHER||Spearman's correlation|-0.933|||<|0.001|TWO_SIDED|95.0|-0.989|-0.652||The reported p-value represents the probability that the strength of the relationship is due to chance at cycles 13-18.|Spearman correlation (non-parametric)|||||-0.652|-0.989|<0.001
72324884|NCT03531814|144172874|OTHER||Spearman's correlation|-0.035||||0.919|TWO_SIDED|95.0|-0.634|0.591||The reported p-value represents the strength of the relationship between the variables for cycles 1-4.|Spearman correlation|||||0.591|-0.634|0.919
72324885|NCT03531814|144172874|OTHER||Spearman's correlation|0.227||||0.528|TWO_SIDED|95.0|-0.487|0.759||The reported p-value represents the strength of the relationship between the variables for cycles 5-8.|Spearman correlation|||||0.759|-0.487|0.528
72324886|NCT03531814|144172874|OTHER||Spearman's correlation|0.179||||0.672|TWO_SIDED|95.0|-0.618|0.794||The reported p-value represents the strength of the relationship between the variables for cycles 9-12.|Spearman correlation|||||0.794|-0.618|0.672
72324887|NCT03531814|144172874|OTHER||Spearman's correlation|0.041||||0.923|TWO_SIDED|95.0|-0.697|0.737||The reported p-value represents the strength of the relationship between the variables for cycles 13-18.|Spearman correlation|||||0.737|-0.697|0.923
72324888|NCT03531814|144172875|OTHER||Spearman's correlation|-0.638||||0.035|TWO_SIDED|95.0|-0.899|-0.041||The reported p-value represents the strength of the relationship between the variables for cycles 1-4.|Spearman correlation|||||-0.041|-0.899|0.035
72324889|NCT03531814|144172875|OTHER||Spearman's correlation|-0.361||||0.306|TWO_SIDED|95.0|-0.815|0.367||The reported p-value represents the strength of the relationship between the variables for cycles 5-8.|Spearman correlation|||||0.367|-0.815|0.306
72324890|NCT03531814|144172875|OTHER||Spearman's correlation|-0.407||||0.317|TWO_SIDED|95.0|-0.87|0.438||The reported p-value represents the strength of the relationship between the variables for cycles 9-12.|Spearman correlation|||||0.438|-0.870|0.317
72606625|NCT01656395|144740868|SUPERIORITY||Mean Difference (Final Values)|-0.004||||0.935|TWO_SIDED|95.0|-0.109|0.1|||cLDA model|||Difference in LS means for average change from Baseline over Week 6 to Week 12 in FEV1: Montelukast vs. Placebo. cLDA model includes terms for visit as categorical variable, prior ICS use (Yes/No) and treatment by visit. Positive differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).||0.1|-0.109|0.935
72606626|NCT01656395|144740871|SUPERIORITY||Mean Difference (Final Values)|-7.2||||0.169|TWO_SIDED|95.0|-17.48|3.08|||ANOVA|||Difference in LS means for percent of asthma exacerbation day over Week 6 through Week 12: MK- 1029 10 mg vs. Placebo. Analysis of variance (ANOVA) model includes the terms for treatment groups and prior ICS use (Yes/No). Negative differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).||3.08|-17.48|0.169
72606627|NCT01656395|144740871|SUPERIORITY||Mean Difference (Final Values)|-9.092||||0.092|TWO_SIDED|95.0|-19.67|1.485|||ANOVA|||Difference in LS means for percent of asthma exacerbation day over Week 6 through Week 12: MK- 1029 30 mg vs. Placebo. ANOVA model includes the terms for treatment groups and prior ICS use (Yes/No). Negative differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).||1.485|-19.67|0.092
72606628|NCT01656395|144740871|SUPERIORITY||Mean Difference (Final Values)|-9.469||||0.083|TWO_SIDED|95.0|-20.19|1.25|||ANOVA|||Difference in LS means for percent of asthma exacerbation day over Week 6 through Week 12: MK- 1029 60 mg vs. Placebo. ANOVA model includes the terms for treatment groups and prior ICS use (Yes/No). Negative differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).||1.25|-20.19|0.083
72606629|NCT01656395|144740871|SUPERIORITY||Mean Difference (Final Values)|-4.666||||0.367|TWO_SIDED|95.0|-14.83|5.501|||ANOVA|||Difference in LS means for percent of asthma exacerbation day over Week 6 through Week 12: MK- 1029 150 mg vs. Placebo. ANOVA model includes the terms for treatment groups and prior ICS use (Yes/No). Negative differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).||5.501|-14.83|0.367
72606630|NCT01656395|144740871|SUPERIORITY||Mean Difference (Final Values)|-5.247||||0.308|TWO_SIDED|95.0|-15.36|4.871|||ANOVA|||Difference in LS means for percent of asthma exacerbation day over Week 6 through Week 12: Montelukast vs. Placebo. ANOVA model includes the terms for treatment groups and prior ICS use (Yes/No). Negative differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).||4.871|-15.36|0.308
72606631|NCT01656395|144740872|SUPERIORITY||Mean Difference (Final Values)|-0.122||||0.429|TWO_SIDED|95.0|-0.427|0.182|||cLDA model|||Difference in LS means for average change from Baseline to Week 12 in DSS: MK-1029 10 mg vs. Placebo. cLDA model includes terms for visit as categorical variable, prior ICS use (Yes/No) and treatment by visit. Negative differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).||0.182|-0.427|0.429
72606632|NCT01656395|144740872|SUPERIORITY||Mean Difference (Final Values)|0.142||||0.37|TWO_SIDED|95.0|-0.169|0.454|||cLDA model|||Difference in LS means for average change from Baseline to Week 12 in DSS: MK-1029 30 mg vs. Placebo. cLDA model includes terms for visit as categorical variable, prior ICS use (Yes/No) and treatment by visit. Negative differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).||0.454|-0.169|0.370
72606633|NCT01656395|144740872|SUPERIORITY||Mean Difference (Final Values)|-0.089||||0.579|TWO_SIDED|95.0|-0.402|0.225|||cLDA model|||Difference in LS means for average change from Baseline to Week 12 in DSS: MK-1029 60 mg vs. Placebo. cLDA model includes terms for visit as categorical variable, prior ICS use (Yes/No) and treatment by visit. Negative differences are in favor of the first treatment group in the comparison (MK- 1029 or Montelukast).||0.225|-0.402|0.579
72606634|NCT01656395|144740872|SUPERIORITY||Mean Difference (Final Values)|0.156||||0.305|TWO_SIDED|95.0|-0.142|0.454|||cLDA model|||Difference in LS means for average change from Baseline to Week 12 in DSS: MK-1029 150 mg vs. Placebo. cLDA model includes terms for visit as categorical variable, prior ICS use (Yes/No) and treatment by visit. Negative differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).||0.454|-0.142|0.305
72606635|NCT01656395|144740872|SUPERIORITY||Mean Difference (Final Values)|-0.136||||0.372|TWO_SIDED|95.0|-0.434|0.163|||cLDA model|||Difference in LS means for average change from Baseline to Week 12 in DSS: Montelukast vs. Placebo. cLDA model includes terms for visit as categorical variable, prior ICS use (Yes/No) and treatment by visit. Negative differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).||0.163|-0.434|0.372
72606636|NCT01656395|144740873|SUPERIORITY||Mean Difference (Final Values)|-0.528||||0.114|TWO_SIDED|95.0|-1.184|0.128|||cLDA model|||Difference in LS means for average change from Baseline over Week 6 to Week 12 in SABA use: MK-1029 10 mg vs. Placebo. cLDA model includes terms for visit as categorical variable, prior ICS use(Yes/No) and treatment by visit. Negative differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).||0.128|-1.184|0.114
72606637|NCT01656395|144740873|SUPERIORITY||Mean Difference (Final Values)|-0.075||||0.827|TWO_SIDED|95.0|-0.75|0.6|||cLDA model|||Difference in LS means for average change from Baseline over Week 6 to Week 12 in SABA use: MK-1029 30 mg vs. Placebo. cLDA model includes terms for visit as categorical variable, prior ICS use (Yes/No) and treatment by visit. Negative differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).||0.6|-0.75|0.827
72324891|NCT03531814|144172875|OTHER||Spearman's correlation|-0.18||||0.67|TWO_SIDED|95.0|-0.795|0.0617||The reported p-value represents the strength of the relationship between the variables for cycles 13-18.|Spearman correlation|||||0.0617|-0.795|0.670
72324892|NCT00952705|144172911|NON_INFERIORITY_OR_EQUIVALENCE|The immune response of Q/LAIV-BFS was declared noninferior to that of trivalent FluMist if the upper bound of the 95% CI for the post dose A/H1N1 GMT ratio was ≤ 1.5. This corresponded to the statistical hypothesis of: Ho: Rj \> 1.5 for any j and Ha: Rj ≤ 1.5 for all j, where Rj was the A/H1N1 post-dose GMT ratio: (FluMist B/Yamagata A/H1N1 + FluMist B/Victoria A/H1N1) divided by Q/LAIV-BFS A/H1N1.|Ratio of geometric mean titers|0.95|||||TWO_SIDED|95.0|0.87|1.03|||Bootstrapping method|Confidence intervals calculated based on bootstrapping method.||Noninferior immune response was assessed by evaluating the upper bound of the 2-sided 95% CIs for the ratio of A/H1N1 GMTs for the specified comparison. Geometric mean titers for the A/H1N1 influenza antigen measurements were calculated as: GMT = antilog\^y (mean \[log\^y x\]) where x was the assay result and y was the natural logarithm.||1.03|0.87|
72324893|NCT00952705|144172911|NON_INFERIORITY_OR_EQUIVALENCE|The immune response of Q/LAIV-BFS was declared noninferior to that of trivalent FluMist if the upper bound of the 95% CI for the post dose A/H3N2 GMT ratio was ≤ 1.5. This corresponded to the statistical hypothesis of: Ho: Rj \> 1.5 for any j and Ha: Rj ≤ 1.5 for all j, where Rj was the A/H3N2 post-dose GMT ratio: (FluMist B/Yamagata A/H3N2 + FluMist B/Victoria A/H3N2) divided by Q/LAIV-BFS A/H3N2.|Ratio of geometric mean titers|0.93|||||TWO_SIDED|95.0|0.85|1.0|||Bootstrapping method|Confidence intervals calculated based on bootstrapping method.||Noninferior immune response was assessed by evaluating the upper bound of the 2-sided 95% CIs for the ratio of A/H3N2 GMTs for the specified comparison. Geometric mean titers for the A/H3N2 influenza antigen measurements were calculated as: GMT = antilog\^y (mean \[log\^y x\]) where x was the assay result and y was the natural logarithm.||1.00|0.85|
72324894|NCT00952705|144172911|NON_INFERIORITY_OR_EQUIVALENCE|The immune response of Q/LAIV-BFS was declared noninferior to that of trivalent FluMist if the upper bound of the 95% CI for the post dose B/Yamagata GMT ratio was ≤ 1.5. This corresponded to the statistical hypothesis of: Ho: Rj \> 1.5 for any j and Ha: Rj ≤ 1.5 for all j, where Rj was the B/Yamagata post-dose GMT ratio: FluMist B/Yamagata divided by Q/LAIV-BFS B/Yamagata.|Ratio of geometric mean titers|0.9|||||TWO_SIDED|95.0|0.79|1.02|||Bootstrapping method|Confidence intervals calculated based on bootstrapping method.||Noninferior immune response was assessed by evaluating the upper bound of the 2-sided 95% CIs for the ratio of B/Yamagata GMTs for the specified comparison. Geometric mean titers for the B/Yamagata influenza antigen measurements were calculated as: GMT = antilog\^y (mean \[log\^y x\]) where x was the assay result and y was the natural logarithm.||1.02|0.79|
72324895|NCT00952705|144172911|NON_INFERIORITY_OR_EQUIVALENCE|The immune response of Q/LAIV-BFS was declared noninferior to that of trivalent FluMist if the upper bound of the 95% CI for the post dose B/Victoria GMT ratio was ≤ 1.5. This corresponded to the statistical hypothesis of: Ho: Rj \> 1.5 for any j and Ha: Rj ≤ 1.5 for all j, where Rj was the B/Victoria post-dose GMT ratio: FluMist B/Victoria divided by Q/LAIV-BFS B/Victoria.|Ratio of geometric mean titers|0.97|||||TWO_SIDED|95.0|0.87|1.1|||Bootstrapping method|Confidence intervals calculated based on bootstrapping method.||Noninferior immune response was assessed by evaluating the upper bound of the 2-sided 95% CIs for the ratio of B/Victoria GMTs for the specified comparison. Geometric mean titers for the B/Victoria influenza antigen measurements were calculated as: GMT = antilog\^y (mean \[log\^y x\]) where x was the assay result and y was the natural logarithm.||1.10|0.87|
72324896|NCT05173974|144172950|SUPERIORITY||Mean Difference (Final Values)|0.15||||0.037|TWO_SIDED|95.0|0.01|0.29||P-value included Bonferroni adjustment.|ANCOVA||ANCOVA with treatment and period as fixed effects; covariates for participant level baseline (natural logged) and period level baseline (natural logged) minus participant level baseline (natural logged). Participants included as a random effect.|||0.29|0.01|0.037
72324897|NCT05173974|144172950|SUPERIORITY||Mean Difference (Final Values)|0.14||||0.044|TWO_SIDED|95.0|0.0|0.28||P-value included Bonferroni adjustment.|ANCOVA||ANCOVA with treatment and period as fixed effects; covariates for participant level baseline (natural logged) and period level baseline (natural logged) minus participant level baseline (natural logged). Participant included as a random effect.|||0.28|0.00|0.044
72324898|NCT05173974|144172950|SUPERIORITY||Mean Difference (Final Values)|0.18||||0.005|TWO_SIDED|95.0|0.06|0.3||unadjusted P-value was presented.|ANCOVA||||ANCOVA with treatment and period as fixed effects; covariates for participant level baseline (natural logged) and period level baseline (natural logged) minus participant level baseline (natural logged). Participants included as a random effect.|0.30|0.06|0.005
72324899|NCT05173974|144172951|SUPERIORITY||Mean Difference (Final Values)|0.06||||0.218|TWO_SIDED|95.0|-0.04|0.17|||ANCOVA||Statistical comparison for AOB 0-0.5|||0.17|-0.04|0.218
72324900|NCT05173974|144172951|SUPERIORITY||Mean Difference (Final Values)|0.11||||0.034|TWO_SIDED|95.0|0.01|0.21|||ANCOVA||Statistical comparison for AOB 0-0.5|||0.21|0.01|0.034
72324901|NCT05173974|144172951|SUPERIORITY||Mean Difference (Final Values)|0.15||||0.004|TWO_SIDED|95.0|0.05|0.25|||ANCOVA||Statistical comparison for AOB 0-0.5|||0.25|0.05|0.004
72324902|NCT05173974|144172951|SUPERIORITY||Mean Difference (Final Values)|0.12||||0.058|TWO_SIDED|95.0|0.0|0.24|||ANCOVA||Statistical comparison for AOB 0-1|||0.24|-0.00|0.058
72324903|NCT05173974|144172951|SUPERIORITY||Mean Difference (Final Values)|0.15||||0.017|TWO_SIDED|95.0|0.03|0.27|||ANCOVA||Statistical comparison for AOB 0-1|||0.27|0.03|0.017
72324904|NCT05173974|144172951|SUPERIORITY||Mean Difference (Final Values)|0.21||||0.001|TWO_SIDED|95.0|0.09|0.33|||ANCOVA||Statistical comparison for AOB 0-1|||0.33|0.09|0.001
72416744|NCT03945188|144344150|SUPERIORITY||Risk Difference (RD)|31.86|||<|0.001|TWO_SIDED|95.0|18.45|45.28|||Cochran-Mantel-Haenszel|||||45.28|18.45|<0.001
72324905|NCT05173974|144172951|SUPERIORITY||Mean Difference (Final Values)|0.18||||0.004|TWO_SIDED|95.0|0.06|0.3|||ANCOVA||Statistical comparison for AOB 0-3|||0.30|0.06|0.004
72324906|NCT05173974|144172951|SUPERIORITY||Mean Difference (Final Values)|0.15||||0.01|TWO_SIDED|95.0|0.04|0.27|||ANCOVA||Statistical comparison for AOB0-3|||0.27|0.04|0.010
72324907|NCT05173974|144172951|SUPERIORITY||Mean Difference (Final Values)|0.19||||0.002|TWO_SIDED|95.0|0.07|0.31|||ANCOVA||Statistical comparison for AOB0-3|||0.31|0.07|0.002
72324908|NCT05173974|144172951|SUPERIORITY||Mean Difference (Final Values)|0.16||||0.022|TWO_SIDED|95.0|0.02|0.29|||ANCOVA||Statistical comparison for AOB 0-6|||0.29|0.02|0.022
72416745|NCT04341116|144344156|SUPERIORITY||Median Difference (Final Values)|9.0|STANDARD_ERROR_OF_MEAN|8.5||0.28|TWO_SIDED|95.0|-6.5|27.0|||Fisher Exact|||||27|-6.5|.28
72324909|NCT05173974|144172951|SUPERIORITY||Mean Difference (Final Values)|0.17||||0.011|TWO_SIDED|95.0|0.04|0.3|||ANCOVA||Statistical comparison for AOB 0-6|||0.30|0.04|0.011
72416746|NCT02219048|144344164|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.0719|STANDARD_ERROR_OF_MEAN|0.0909|||TWO_SIDED|90.0|-0.2243|0.0805|||Longitudinal Analysis of Covariance|LANCOVA model contained fixed factors of treatment, week, treatment/baseline by week interaction, baseline value, and unstructured covariance matrix.||Change From Baseline at Week 1||0.0805|-0.2243|
72416747|NCT02219048|144344164|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.092|STANDARD_ERROR_OF_MEAN|0.086|||TWO_SIDED|90.0|-0.2362|0.0523|||Longitudinal Analysis of Covariance|LANCOVA model contained fixed factors of treatment, week, treatment/baseline by week interaction, baseline value, and unstructured covariance matrix.||Change From Baseline at Week 2||0.0523|-0.2362|
72416748|NCT02219048|144344164|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1131|STANDARD_ERROR_OF_MEAN|0.0837|||TWO_SIDED|90.0|-0.2536|0.0274|||Longitudinal Analysis of Covariance|LANCOVA model contained fixed factors of treatment, week, treatment/baseline by week interaction, baseline value, and unstructured covariance matrix.||Change From Baseline at Week 3||0.0274|-0.2536|
72324910|NCT05173974|144172951|SUPERIORITY||Mean Difference (Final Values)|0.19||||0.005|TWO_SIDED|95.0|0.06|0.33|||ANCOVA||Statistical comparison for AOB 0-6|||0.33|0.06|0.005
72416749|NCT02219048|144344164|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.058|STANDARD_ERROR_OF_MEAN|0.0829|||TWO_SIDED|90.0|-0.1971|0.0812|||Longitudinal Analysis of Covariance|LANCOVA model contained fixed factors of treatment, week, treatment/baseline by week interaction, baseline value, and unstructured covariance matrix.||Change From Baseline at Week 4||0.0812|-0.1971|
72416750|NCT02219048|144344164|SUPERIORITY_OR_OTHER||Median Difference (Net)|-0.0837|STANDARD_ERROR_OF_MEAN|0.0742|||TWO_SIDED|90.0|-0.2081|0.0406|||Longitudinal Analysis of Covariance|LANCOVA model contained fixed factors of treatment, week, treatment/baseline by week interaction, baseline value, and unstructured covariance matrix.||Change From Baseline Over Week 1 to 4||0.0406|-0.2081|
72416751|NCT02219048|144344167|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.09|STANDARD_ERROR_OF_MEAN|0.116|||TWO_SIDED|90.0|-0.285|0.106|||Longitudinal Analysis of Covariance|LANCOVA model contained fixed factors of treatment, week, treatment/baseline by week interaction, baseline value, and unstructured covariance matrix.||Change From Baseline Averaged Over Week 1 to 4||0.106|-0.285|
72324911|NCT05173974|144172951|SUPERIORITY||Mean Difference (Final Values)|0.14||||0.037|TWO_SIDED|95.0|0.01|0.27|||ANCOVA||Statistical comparison for AOB 0-9|||0.27|0.01|0.037
72324912|NCT05173974|144172951|SUPERIORITY||Mean Difference (Final Values)|0.17||||0.013|TWO_SIDED|95.0|0.04|0.3|||ANCOVA||Statistical comparison for AOB 0-9|||0.30|0.04|0.013
72324913|NCT05173974|144172951|SUPERIORITY||Mean Difference (Final Values)|0.19||||0.005|TWO_SIDED|95.0|0.06|0.32|||ANCOVA||Statistical comparison for AOB 0-9|||0.32|0.06|0.005
72416752|NCT02219048|144344169|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.017|STANDARD_ERROR_OF_MEAN|10.003|||TWO_SIDED|90.0|-10.76|22.794|||Longitudinal Analysis of Covariance|LANCOVA model contained fixed factors of treatment, week, treatment/baseline by week interaction, baseline value, and unstructured covariance matrix.||Morning PEF: CFB at Week 1||22.794|-10.760|
72324914|NCT02098304|144172952|SUPERIORITY_OR_OTHER||Percentage agreement|72.3|||<|0.001|TWO_SIDED|95.0|59.8|82.7|||Exact binomial test|An exact binomial test was used and an exact 95% Confidence Interval using the Clopper-Pearson method was calculated.||The null hypothesis was of chance agreement (50%) and was tested against a two-sided alternative at the 5% level of significance.||82.7|59.8|<0.001
72324915|NCT02098304|144172952|SUPERIORITY_OR_OTHER||Cohen's kappa|0.45||||0.001|TWO_SIDED|95.0|0.24|0.66|||Cohen's Kappa||Cohen's kappa is a chance-adjusted measure of agreement. A value of 0 indicates agreement by chance and 1 perfect agreement.|The null hypothesis was of chance agreement (Cohen's kappa of 0) and was tested against a two-sided alternative at the 5% level of significance. The study was powered such that 58 teeth (29 subjects), there would be 95% power to reject the null hypothesis of chance agreement (Cohen's kappa of 0) at the 5% level of significance, given that it was expected to be at least 0.4.||0.66|0.24|0.001
72324916|NCT03289143|144172956|SUPERIORITY|||||||0.6147||||||Unadjusted|Mixed-effect Model Repeated Measures|||||||0.6147
72324917|NCT03289143|144172956|SUPERIORITY|||||||0.5778||||||Unadjusted|Mixed-effect Model Repeated Measures|||||||0.5778
72324918|NCT03289143|144172956|SUPERIORITY|||||||0.5136||||||Unadjusted|Mixed-effect Model Repeated Measures|||||||0.5136
72324919|NCT03289143|144172958|SUPERIORITY|||||||0.8198||||||Unadjusted|Mixed-effect Model Repeated Measures|||||||0.8198
72324920|NCT03289143|144172958|SUPERIORITY|||||||0.3961||||||Unadjusted|Mixed-effect Model Repeated Measures|||||||0.3961
72324921|NCT03289143|144172958|SUPERIORITY|||||||0.6043||||||Unadjusted|Mixed-effect Model Repeated Measures|||||||0.6043
72324922|NCT03289143|144172959|SUPERIORITY|||||||0.0783||||||Unadjusted|Mixed-effect Model Repeated Measures|||||||0.0783
72324923|NCT03289143|144172959|SUPERIORITY|||||||0.601||||||Unadjusted|Mixed-effect Model Repeated Measures|||||||0.6010
72324924|NCT03289143|144172959|SUPERIORITY|||||||0.3961||||||Unadjusted|Mixed-effect Model Repeated Measures|||||||0.3961
72324925|NCT03289143|144172960|SUPERIORITY|||||||0.9749||||||Unadjusted|Mixed-effect Model Repeated Measures|||||||0.9749
72324926|NCT03289143|144172960|SUPERIORITY|||||||0.7718||||||Unadjusted|Mixed-effect Model Repeated Measures|||||||0.7718
72324927|NCT03289143|144172960|SUPERIORITY|||||||0.5789||||||Unadjusted|Mixed-effect Model Repeated Measures|||||||0.5789
72324928|NCT03289143|144172961|SUPERIORITY|||||||0.5235||||||Unadjusted|Mixed-effect Model Repeated Measures|||||||0.5235
72324929|NCT03289143|144172961|SUPERIORITY|||||||0.5612||||||Unadjusted|Mixed-effect Model Repeated Measures|||||||0.5612
72324930|NCT03289143|144172961|SUPERIORITY|||||||0.713||||||Unadjusted|Mixed-effect Model Repeated Measures|||||||0.7130
72324931|NCT00730756|144172966|SUPERIORITY_OR_OTHER|||||||0.845||95.0|||||ANCOVA|Center, baseline eosinophils, baseline symptom score, age, and gender were included as covariates in all efficacy analyses.||||||0.845
72324932|NCT01152307|144172978|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.42|STANDARD_DEVIATION|1.6||0.01|TWO_SIDED|95.0|0.76|6.09|||t-test, 2 sided|||We tested for a difference in the mean total knowledge score between the decision aid and control groups using independent t-test (2 sided). With 100 patients in each arm, the study had more than 90% power to detect a 10% difference in knowledge assuming a common standard deviation of 18%.||6.09|0.76|0.01
72606638|NCT01656395|144740873|SUPERIORITY||Mean Difference (Final Values)|-0.11||||0.75|TWO_SIDED|95.0|-0.789|0.569|||cLDA model|||Difference in LS means for average change from Baseline over Week 6 to Week 12 in SABA use: MK-1029 60 mg vs. Placebo. cLDA model includes terms for visit as categorical variable, prior ICS use (Yes/No) and treatment by visit. Negative differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).||0.569|-0.789|0.75
72606639|NCT01656395|144740873|SUPERIORITY||Mean Difference (Final Values)|0.275||||0.403|TWO_SIDED|95.0|-0.371|0.921|||cLDA model|||Difference in LS means for average change from Baseline over Week 6 to Week 12 in SABA use: MK-1029 150 mg vs. Placebo. cLDA model includes terms for visit as categorical variable, prior ICS use (Yes/No) and treatment by visit. Negative differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).||0.921|-0.371|0.403
72606640|NCT01656395|144740873|SUPERIORITY||Mean Difference (Final Values)|-0.389||||0.237|TWO_SIDED|95.0|-1.035|0.257|||cLDA model|||Difference in LS means for average change from Baseline over Week 6 to Week 12 in SABA use: Montelukast vs. Placebo. cLDA model includes terms for visit as categorical variable, prior ICS use (Yes/No) and treatment by visit. Negative differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).||0.257|-1.035|0.237
72606641|NCT01656395|144740874|SUPERIORITY||Mean Difference (Final Values)|-0.241||||0.565|TWO_SIDED|95.0|-1.066|0.583|||cLDA model|||Difference in LS means for average change from Baseline over Week 6 to Week 12 in nocturnal awakenings: MK-1029 10 mg vs. Placebo. cLDA model includes terms for visit as categorical variable, prior ICS use (Yes/No) and treatment by visit. Negative differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).||0.583|-1.066|0.565
72606642|NCT01656395|144740874|SUPERIORITY||Mean Difference (Final Values)|0.135||||0.754|TWO_SIDED|95.0|-0.713|0.983|||cLDA model|||Difference in LS means for average change from Baseline over Week 6 to Week 12 in nocturnal awakenings: MK-1029 30 mg vs. Placebo. cLDA model includes terms for visit as categorical variable, prior ICS use (Yes/No) and treatment by visit. Negative differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).||0.983|-0.713|0.754
72606643|NCT01656395|144740874|SUPERIORITY||cLDA model|-0.251||||0.563|TWO_SIDED|95.0|-1.104|0.603|||cLDA model|||Difference in LS means for average change from Baseline over Week 6 to Week 12 in nocturnal awakenings: MK-1029 60 mg vs. Placebo. cLDA model includes terms for visit as categorical variable, prior ICS use (Yes/No) and treatment by visit. Negative differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).||0.603|-1.104|0.563
72416753|NCT02219048|144344169|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.591|STANDARD_ERROR_OF_MEAN|12.228|||TWO_SIDED|90.0|-13.926|27.108|||Longitudinal Analysis of Covariance|LANCOVA model contained fixed factors of treatment, week, treatment/baseline by week interaction, baseline value, and unstructured covariance matrix.||Morning PEF: CFB at Week 2||27.108|-13.926|
72416754|NCT02219048|144344169|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.954|STANDARD_ERROR_OF_MEAN|11.673|||TWO_SIDED|90.0|-18.644|20.552|||Longitudinal Analysis of Covariance|LANCOVA model contained fixed factors of treatment, week, treatment/baseline by week interaction, baseline value, and unstructured covariance matrix.||Morning PEF: CFB at Week 3||20.552|-18.644|
72606644|NCT01656395|144740874|SUPERIORITY||Mean Difference (Final Values)|-0.241||||0.559|TWO_SIDED|95.0|-1.053|0.571|||cLDA model|||Difference in LS means for average change from Baseline over Week 6 to Week 12 in nocturnal awakenings: MK-1029 150 mg vs. Placebo. cLDA model includes terms for visit as categorical variable, prior ICS use (Yes/No) and treatment by visit. Negative differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).||0.571|-1.053|0.559
72324933|NCT01126190|144172980|NON_INFERIORITY|Non-inferiority was demonstrated if the upper endpoint of the CI for the difference in mean DSN was less than or equal to 0.62 days|Mean Difference (Final Values)|0.1|||||TWO_SIDED|95.0|-0.13|0.37||||||For the primary non-inferiority endpoint of cycle 1 DSN, the 95% confidence interval (CI) for difference in DSN was calculated by stratified bootstrap resampling.||0.37|-0.13|
72324934|NCT00524121|144172987|SUPERIORITY_OR_OTHER|||||||0.011|||||||Wilcoxon signed rank test|||||||0.011
72324935|NCT00524121|144172988|SUPERIORITY_OR_OTHER|||||||0.115||95.0|||||Log Rank|||||||0.115
72324936|NCT00524121|144172989|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||||||1.000
72324937|NCT00524121|144172990|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||||||1.000
72416755|NCT02219048|144344169|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.368|STANDARD_ERROR_OF_MEAN|12.92|||TWO_SIDED|90.0|-26.069|17.333|||Longitudinal Analysis of Covariance|LANCOVA model contained fixed factors of treatment, week, treatment/baseline by week interaction, baseline value, and unstructured covariance matrix.||Morning PEF: CFB at Week 4||17.333|-26.069|
72416756|NCT02219048|144344169|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.299|STANDARD_ERROR_OF_MEAN|10.503|||TWO_SIDED|90.0|-15.323|19.92|||Longitudinal Analysis of Covariance|LANCOVA model contained fixed factors of treatment, week, treatment/baseline by week interaction, baseline value, and unstructured covariance matrix.||Morning PEF: CFB Averaged Over 4 Weeks||19.920|-15.323|
72416757|NCT02219048|144344169|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.135|STANDARD_ERROR_OF_MEAN|10.961|||TWO_SIDED|90.0|-17.248|19.519|||Longitudinal Analysis of Covariance|LANCOVA model contained fixed factors of treatment, week, treatment/baseline by week interaction, baseline value, and unstructured covariance matrix.||Evening PEF: CFB at Week 1||19.519|-17.248|
72416758|NCT02219048|144344169|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.834|STANDARD_ERROR_OF_MEAN|9.956|||TWO_SIDED|90.0|-13.871|19.54|||Longitudinal Analysis of Covariance|LANCOVA model contained fixed factors of treatment, week, treatment/baseline by week interaction, baseline value, and unstructured covariance matrix.||Evening PEF: CFB at Week 2||19.540|-13.871|
72606645|NCT01656395|144740874|SUPERIORITY||Mean Difference (Final Values)|-0.071||||0.863|TWO_SIDED|95.0|-0.883|0.741|||cLDA model|||Difference in LS means for average change from Baseline over Week 6 to Week 12 in nocturnal awakenings: Montelukast vs. Placebo. cLDA model includes terms for visit as categorical variable, prior ICS use (Yes/No) and treatment by visit. Negative differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).||0.741|-0.883|0.863
72606646|NCT01656395|144740875|SUPERIORITY||Mean Difference (Final Values)|0.544||||0.958|TWO_SIDED|95.0|-19.92|21.007|||cLDA model|||Difference in LS means for average change from Baseline over Week 6 to Week 12 in AM/PM PEF: MK-1029 10 mg vs. Placebo. cLDA model includes terms for visit as categorical variable, prior ICS use (Yes/No) and treatment by visit. Negative differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).||21.007|-19.92|0.958
72324938|NCT00524121|144172991|SUPERIORITY_OR_OTHER|||||||0.5467|||||||Fisher Exact|||||||0.5467
72324939|NCT01114737|144172992|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.2|STANDARD_ERROR_OF_MEAN|2.3||0.085|TWO_SIDED|95.0|-8.9|0.6|||ANCOVA|Adjusted for baseline ADHD-RS/ASRS total score, age group, and ADHD medication.||||0.6|-8.9|0.085
72324940|NCT01114737|144172993|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.4|STANDARD_ERROR_OF_MEAN|0.9||0.669|TWO_SIDED|95.0|-1.5|2.3|||ANCOVA|Adjusted for baseline HAMA Anxiety Scale Total Score, age group, ADHD symptom, and ADHD medication.||||2.3|-1.5|0.669
72324941|NCT01114737|144172994|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.4|STANDARD_ERROR_OF_MEAN|0.8||0.588|TWO_SIDED|95.0|-1.1|1.9|||ANCOVA|Adjusted for Baseline HAM-D Rating Scale Total Score, age group, ADHD symptom, and ADHD medication.||||1.9|-1.1|0.588
72324942|NCT01114737|144172995|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.2||0.531|TWO_SIDED|95.0|-0.4|0.2|||ANCOVA|Adjusted for baseline CGI-Severity Response, age group, ADHD symptom, and ADHD medication.||||0.2|-0.4|0.531
72324943|NCT01114737|144172996|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0|STANDARD_ERROR_OF_MEAN|2.2||0.661|TWO_SIDED|95.0|-5.5|3.6|||ANCOVA|Adjusted for Baseline BRIEF Adult-GEC T Score, ADHD symptom, and ADHD medication.||||3.6|-5.5|0.661
72324944|NCT01114737|144172997|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.1|STANDARD_ERROR_OF_MEAN|1.9||0.034|TWO_SIDED|95.0|-7.9|-0.3|||ANCOVA|Adjusted for Baseline BRIEF Parent-GEC T Score, ADHD symptom, and ADHD medication.||||-0.3|-7.9|0.034
72324945|NCT01114737|144172998|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.6|STANDARD_ERROR_OF_MEAN|2.6||0.312|TWO_SIDED|95.0|-2.6|7.8|||ANCOVA|Adjusted for Week 13 ADHD RS/ASRS Total Score, age group, and ADHD medication.||||7.8|-2.6|0.312
72324946|NCT01114737|144172999|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|1.0||0.59|TWO_SIDED|95.0|-2.4|1.4|||ANCOVA|Adjusted for Week 13 HAMA Anxiety Rating Scale Total Score, age group, ADHD symptom, and ADHD medication.||||1.4|-2.4|0.590
72324947|NCT01114737|144173000|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.4|STANDARD_ERROR_OF_MEAN|0.8||0.636|TWO_SIDED|95.0|-1.2|1.9|||ANCOVA|Adjusted for Week 13 HAMD Rating Scale Total Score, age group, ADHD symptom, and ADHD||||1.9|-1.2|0.636
72324948|NCT01114737|144173001|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.2||0.51|TWO_SIDED|95.0|-0.2|0.5|||ANCOVA|Adjusted for Week 13 Global Impression-Severity Score, ADHD symptom, and ADHD medication.||||0.5|-0.2|0.510
72416759|NCT02219048|144344169|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.374|STANDARD_ERROR_OF_MEAN|11.652|||TWO_SIDED|90.0|-27.933|11.185|||Longitudinal Analysis of Covariance|LANCOVA model contained fixed factors of treatment, week, treatment/baseline by week interaction, baseline value, and unstructured covariance matrix.||Evening PEF: CFB at Week 3||11.185|-27.933|
72324949|NCT01114737|144173002|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.6|STANDARD_ERROR_OF_MEAN|1.8||0.395|TWO_SIDED|95.0|-2.1|5.2|||ANCOVA|Adjusted for Week 13 BRIEF Adult-GEC T Score, ADHD symptom, and ADHD medication.||||5.2|-2.1|0.395
72324950|NCT01114737|144173003|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.3|STANDARD_ERROR_OF_MEAN|1.7||0.443|TWO_SIDED|95.0|-2.1|4.7|||ANCOVA|Adjusted for Week 13 BRIEF Parent-GEC T Score, ADHD symptom, and ADHD medication.||||4.7|-2.1|0.443
72324951|NCT01114737|144173004|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|2.8||0.953|TWO_SIDED|95.0|-5.5|5.8|||ANCOVA|Adjusted for Baseline ADHD-RS/ASRS Total Score, ADHD symptom, and ADHD medication.||||5.8|-5.5|0.953
72324952|NCT01114737|144173005|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|1.0||0.733|TWO_SIDED|95.0|-2.4|1.7|||ANCOVA|Adjusted for Baseline Hamilton Anxiety Rating Scale (HAM-A) Score, ADHD symptom, and ADHD medication.||||1.7|-2.4|0.733
72324953|NCT01114737|144173006|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.5|STANDARD_ERROR_OF_MEAN|0.8||0.522|TWO_SIDED|95.0|-1.1|2.2|||ANCOVA|Adjusted for Baseline Hamilton Rating Scale For Depression (HAM-D) Score, ADHD symptom, and ADHD medication.||||2.2|-1.1|0.522
72324954|NCT01114737|144173007|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.2||0.564|TWO_SIDED|95.0|-0.2|0.4|||ANCOVA|Adjusted for Baseline Clinical Global Impression-Severity (CGI-S), ADHD symptom, and ADHD medication.||||0.4|-0.2|0.564
72324955|NCT01114737|144173008|SUPERIORITY_OR_OTHER||Relative Risk|0.87||||0.67|TWO_SIDED|95.0|0.46|1.64|||Cochran-Mantel-Haenszel|Adjusted for age group, ADHD symptom, and ADHD medication||||1.64|0.46|0.67
72324956|NCT01114737|144173009|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|2.8||0.833|TWO_SIDED|95.0|-6.2|5.0|||ANCOVA|Adjusted for Baseline BRIEF Adult-GEC T Score, ADHD symptom, and ADHD medication.||||5.0|-6.2|0.833
72416760|NCT02219048|144344169|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.445|STANDARD_ERROR_OF_MEAN|13.573|||TWO_SIDED|90.0|-23.245|22.356|||Longitudinal Analysis of Covariance|LANCOVA model contained fixed factors of treatment, week, treatment/baseline by week interaction, baseline value, and unstructured covariance matrix.||Evening PEF: CFB at Week 4||22.356|-23.245|
72416761|NCT02219048|144344169|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.212|STANDARD_ERROR_OF_MEAN|10.317|||TWO_SIDED|90.0|-18.52|16.096|||Longitudinal Analysis of Covariance|LANCOVA model contained fixed factors of treatment, week, treatment/baseline by week interaction, baseline value, and unstructured covariance matrix.||Evening PEF: CFB Averaged Over 4 Weeks||16.096|-18.520|
72324957|NCT01114737|144173010|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.2|STANDARD_ERROR_OF_MEAN|2.0||0.279|TWO_SIDED|95.0|-6.3|1.8|||ANCOVA|Adjusted for Baseline BRIEF Parent-GEC T Score, ADHD symptom, and ADHD medication.||||1.8|-6.3|0.279
72324958|NCT00457392|144173018|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.942||||0.1933|TWO_SIDED|95.0|0.822|1.079||p-value was not adjusted for multiple comparisons.|Log Rank|||Differences in OS between treatment arms was analyzed by the 1-sided log rank test, stratified for smoking status (ever versus never), prior bevacizumab therapy (yes versus no) and epidermal growth factor receptor (EGFR) status (positive, versus negative, versus unknown).||1.079|0.822|0.1933
72324959|NCT00457392|144173019|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.807||||0.0023|TWO_SIDED|95.0|0.695|0.937||No p-value is adjusted for multiple comparisons for PFS.|Log Rank|One-sided log-rank test with alpha=0.025 was used.||Differences in PFS between treatment arms was analyzed by the 1-sided log rank test, stratified for smoking status (ever versus never), prior bevacizumab therapy (yes versus no) and EGFR status (positive, versus negative, versus unknown).||0.937|0.695|0.0023
72324960|NCT00457392|144173020|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.514||||0.0471|TWO_SIDED|95.0|1.002|2.289|||Cochran-Mantel-Haenszel|||The Cochran-Mantel-Haenszel (CMH) test stratified for smoking status (ever versus never), prior bevacizumab therapy (yes versus no) and EGFR status (positive, versus negative, versus unknown) was used to compare ORR between the 2 treatment arms. The relative risk ratio estimator was used to contrast the treatment effects on response rates. A point estimate of relative risk ratio and 2-sided 95% CI was calculated.||2.289|1.002|0.0471
72324961|NCT00448448|144173041|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.93|||<|0.0267|TWO_SIDED|95.0|1.08|3.46|||Regression, Logistic|The success rate was adjusted for the propensity score (probability of receiving a brace) and the duration of follow-up.||||3.46|1.08|<0.0267
72324962|NCT04436744|144173126|SUPERIORITY|||||||0.0433|||||||t-test, 2 sided|||||||0.0433
72324963|NCT04436744|144173127|SUPERIORITY||Difference in Overall Response Rates|-0.93||||0.8272|TWO_SIDED|95.0|-14.66|12.81|||Cochran-Mantel-Haenszel|||ORR was calculated using the stratified Cochran-Mantel-Haenszel test.||12.81|-14.66|0.8272
72324964|NCT04436744|144173128|SUPERIORITY||Difference in Rate|6.86|||||TWO_SIDED|95.0|-4.25|17.97||||||||17.97|-4.25|
72324965|NCT01374425|144173179|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.79||||0.0555|TWO_SIDED|95.0|0.61|1.01||P-value (relative to Bevacizumab + mFOLFOX6) based on two-sided stratified log rank test and not adjusted for multiple comparisons.|Log Rank||Hazard ratio (HR) (relative to Bevacizumab + mFOLFOX6) was estimated by Cox regression.|Analysis stratified by high/low excision repair cross-complementing (ERCC)-1 level and region of enrollment.||1.01|0.61|0.0555
72324966|NCT01374425|144173180|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.84||||0.3944|TWO_SIDED|95.0|0.56|1.26||P-value (relative to Bevacizumab + mFOLFOX6) based on two-sided stratified log rank test and not adjusted for multiple comparisons.|Log Rank||HR (relative to Bevacizumab + mFOLFOX6) was estimated by Cox regression.|Analysis stratified by region of enrollment.||1.26|0.56|0.3944
72324967|NCT01374425|144173181|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.76||||0.0786|TWO_SIDED|95.0|0.55|1.03||P-value (relative to Bevacizumab + mFOLFOX6) based on two-sided stratified log rank test and not adjusted for multiple comparisons.|Log Rank||HR (relative to Bevacizumab + mFOLFOX6) was estimated by Cox regression.|Analysis stratified by region of enrollment.||1.03|0.55|0.0786
72416762|NCT01618162|144344210|SUPERIORITY_OR_OTHER||Estimated treatment difference|-1.02|||<|0.001|TWO_SIDED|95.0|-1.18|-0.87|||ANCOVA|||Superiority of IDegLira versus placebo therapy would be concluded if the 95% CI for the treatment differences for change in HbA1c lied entirely below 0%; implying that the two-sided p-value calculated by the ANCOVA model for testing the hypothesis of no difference between treatments was less than 5%.||-0.87|-1.18|< 0.001
72324968|NCT01374425|144173182|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.99||||0.9576|TWO_SIDED|95.0|0.77|1.28||P-value (relative to ERCC-1 Low subgroup) based on two-sided stratified log rank test and not adjusted for multiple comparisons.|Log Rank||HR (relative to ERCC-1 Low subgroup) was estimated by Cox regression.|Analysis stratified by region of enrollment.||1.28|0.77|0.9576
72324969|NCT01374425|144173183|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.19||||0.1658|TWO_SIDED|95.0|0.93|1.53||P-value (relative to VEGF-A Low subgroup) based on two-sided stratified log rank test and not adjusted for multiple comparisons.|Log Rank||HR (relative to VEGF-A Low subgroup) was estimated by Cox regression.|Analysis stratified by high/low ERCC-1 level and region of enrollment.||1.53|0.93|0.1658
72324970|NCT01374425|144173184|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.73||||0.3019|TWO_SIDED|95.0|0.41|1.32||P-value (relative to Bevacizumab + mFOLFOX6) based on two-sided stratified log rank test and not adjusted for multiple comparisons.|Log Rank||HR (relative to Bevacizumab + mFOLFOX6) was estimated by Cox regression.|Analysis stratified by region of enrollment.||1.32|0.41|0.3019
72324971|NCT01374425|144173185|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.86||||0.6035|TWO_SIDED|95.0|0.48|1.53||P-value (relative to Bevacizumab + mFOLFOX6) based on two-sided stratified log rank test and not adjusted for multiple comparisons.|Log Rank||HR (relative to Bevacizumab + mFOLFOX6) was estimated by Cox regression.|Analysis stratified by region of enrollment.||1.53|0.48|0.6035
72324972|NCT01374425|144173186|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.83||||0.4032|TWO_SIDED|95.0|0.54|1.28||P-value (relative to Bevacizumab + mFOLFOX6) based on two-sided stratified log rank test and not adjusted for multiple comparisons.|Log Rank||HR (relative to Bevacizumab + mFOLFOX6) was estimated by Cox regression.|Analysis stratified by region of enrollment.||1.28|0.54|0.4032
72324973|NCT01374425|144173187|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.65||||0.0647|TWO_SIDED|95.0|0.41|1.03||P-value (relative to Bevacizumab + mFOLFOX6) based on two-sided stratified log rank test and not adjusted for multiple comparisons.|Log Rank||HR (relative to Bevacizumab + mFOLFOX6) was estimated by Cox regression.|Analysis stratified by region of enrollment.||1.03|0.41|0.0647
72416763|NCT04124926|144344217|NON_INFERIORITY|The noninferiority of vonoprazan to lansoprazole was evaluated with a Farrington and Manning test with a noninferiority margin of 10 percentage points for the difference in EE rates between treatments (vonoprazan minus lansoprazole).|difference in percentage|8.3|||<|0.0001|TWO_SIDED|95.0|4.49|12.23||2-sided p-value.|Farrington and Manning test||The 2-sided 95% confidence interval (CI) of the difference in EE healing rates between vonoprazan 20 mg and lansoprazole 30 mg was calculated via the Miettinen and Nurminen method.|||12.23|4.49|<0.0001
72416764|NCT04124926|144344218|NON_INFERIORITY|The noninferiority of each dose group of vonoprazan to lansoprazole was evaluated with a Farrington and Manning test with a noninferiority margin of 10 percentage points for the difference in maintenance of healing rates between treatments (vonoprazan minus lansoprazole).|difference in percentage|8.7|||<|0.0001|TWO_SIDED|95.0|1.8|15.53||2-sided p-value.|Farrington and Manning test||The 2-sided 95% CI of the difference in EE maintenance rates between each vonoprazan group and lansoprazole group was calculated via the Miettinen and Nurminen method.|||15.53|1.80|<0.0001
72606647|NCT01656395|144740875|SUPERIORITY||Mean Difference (Final Values)|6.251||||0.559|TWO_SIDED|95.0|-14.81|27.307|||cLDA model|||Difference in LS means for average change from Baseline over Week 6 to Week 12 in AM/PM PEF: MK- 1029 30 mg vs. Placebo. cLDA model includes terms for visit as categorical variable, prior ICS use (Yes/No) and treatment by visit. Negative differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).||27.307|-14.81|0.559
72324974|NCT01374425|144173188|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.76||||0.0861|TWO_SIDED|95.0|0.56|1.04||P-value (relative to Bevacizumab + mFOLFOX6) based on two-sided stratified log rank test and not adjusted for multiple comparisons.|Log Rank||HR (relative to Bevacizumab + mFOLFOX6) was estimated by Cox regression.|Analysis stratified by high/low ERCC-1 level and region of enrollment.||1.04|0.56|0.0861
72324975|NCT01374425|144173189|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.8||||0.3295|TWO_SIDED|95.0|0.51|1.26||P-value (relative to Bevacizumab + mFOLFOX6) based on two-sided stratified log rank test and not adjusted for multiple comparisons.|Log Rank||HR (relative to Bevacizumab + mFOLFOX6) was estimated by Cox regression.|Analysis stratified by region of enrollment.||1.26|0.51|0.3295
72324976|NCT01374425|144173190|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.74||||0.1519|TWO_SIDED|95.0|0.49|1.12||P-value (relative to Bevacizumab + mFOLFOX6) based on two-sided stratified log rank test and not adjusted for multiple comparisons.|Log Rank||HR (relative to Bevacizumab + mFOLFOX6) was estimated by Cox regression.|Analysis stratified by region of enrollment.||1.12|0.49|0.1519
72324977|NCT01374425|144173191|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.19||||0.2774|TWO_SIDED|95.0|0.87|1.62||P-value (relative to ERCC-1 Low subgroup) based on two-sided stratified log rank test and not adjusted for multiple comparisons.|Log Rank||HR (relative to ERCC-1 Low subgroup) was estimated by Cox regression.|Analysis stratified by region of enrollment.||1.62|0.87|0.2774
72324978|NCT01374425|144173192|SUPERIORITY_OR_OTHER||Difference in Objective Response Rates|4.3|||||TWO_SIDED|95.0|-5.5|14.0|||||The difference was calculated as the percentage of participants with objective response in the Bevacizumab + FOLFIRI arm minus the Bevacizumab + mFOLFOX6 arm. The 95% CI was computed using normal approximation to the binomial distribution.|||14.0|-5.5|
72606648|NCT01656395|144740875|SUPERIORITY||Median Difference (Final Values)|9.575||||0.374|TWO_SIDED|95.0|-11.62|30.766|||cLDA model|||Difference in LS means for average change from Baseline over Week 6 to Week 12 in AM/PM PEF: MK-1029 60 mg vs. Placebo. cLDA model includes terms for visit as categorical variable, prior ICS use (Yes/No) and treatment by visit. Negative differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).||30.766|-11.62|0.374
72606649|NCT01656395|144740875|SUPERIORITY||Mean Difference (Final Values)|5.114||||0.618|TWO_SIDED|95.0|-15.04|25.272|||cLDA model|||Difference in LS means for average change from Baseline over Week 6 to Week 12 in AM/PM PEF: MK-1029 150 mg vs. Placebo. cLDA model includes terms for visit as categorical variable, prior ICS use (Yes/No) and treatment by visit. Negative differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).||25.272|-15.04|0.618
72606650|NCT01656395|144740875|SUPERIORITY||Mean Difference (Final Values)|-1.604||||0.876|TWO_SIDED|95.0|-21.76|18.554|||cLDA model|||Difference in LS means for average change from Baseline over Week 6 to Week 12 in AM/PM PEF: Montelukast vs. Placebo. cLDA model includes terms for visit as categorical variable, prior ICS use (Yes/No) and treatment by visit. Negative differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).||18.554|-21.76|0.876
72606651|NCT01656395|144740876|SUPERIORITY||Mean Difference (Final Values)|0.076||||0.682|TWO_SIDED|95.0|-0.288|0.44|||cLDA model|||Difference in LS means for change from Baseline to Week 12 in AQLQ(S) Overall Score: MK-1029 10 mg vs. Placebo. cLDA model includes terms for visit as categorical variable, prior ICS use (Yes/No) and treatment by visit. Positive differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).||0.440|-0.288|0.682
72606652|NCT01656395|144740876|SUPERIORITY||Mean Difference (Final Values)|-0.047||||0.807|TWO_SIDED|95.0|-0.422|0.329|||cLDA model|||Difference in LS means for change from Baseline to Week 12 in AQLQ(S) Overall Score: MK-1029 30 mg vs. Placebo. cLDA model includes terms for visit as categorical variable, prior ICS use (Yes/No) and treatment by visit. Positive differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).||0.329|-0.422|0.807
72606653|NCT01656395|144740876|SUPERIORITY||Mean Difference (Final Values)|0.165||||0.403|TWO_SIDED|95.0|-0.222|0.552|||cLDA model|||Difference in LS means for change from Baseline to Week 12 in AQLQ(S) Overall Score: MK-1029 60 mg vs. Placebo. cLDA model includes terms for visit as categorical variable, prior ICS use (Yes/No) and treatment by visit. Positive differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).||0.552|-0.222|0.403
72606654|NCT01656395|144740876|SUPERIORITY||Mean Difference (Final Values)|0.375||||0.051|TWO_SIDED|95.0|-0.001|0.751|||cLDA model|||Difference in LS means for change from Baseline to Week 12 in AQLQ(S) Overall Score: MK-1029 150 mg vs. Placebo. cLDA model includes terms for visit as categorical variable, prior ICS use (Yes/No) and treatment by visit. Positive differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).||0.751|-0.001|0.051
72606655|NCT01656395|144740876|SUPERIORITY||Mean Difference (Final Values)|0.319||||0.086|TWO_SIDED|95.0|-0.045|0.683|||cLDA model|||Difference in LS means for change from Baseline to Week 12 in AQLQ(S) Overall Score: Montelukast vs. Placebo. cLDA model includes terms for visit as categorical variable, prior ICS use (Yes/No) and treatment by visit. Positive differences are in favor of the first treatment group in the comparison (MK- 1029 or Montelukast).||0.683|-0.045|0.086
72606656|NCT01656395|144740877|SUPERIORITY||Mean Difference (Final Values)|2.8||||0.7687|TWO_SIDED|95.0|-16.0|21.3|||MN method|||Difference for AQLQ(S) Response Rate: MK-1029 10 mg vs. Placebo. P-values, estimates and 95% confidence intervals (CIs) are based on the Miettinen and Nurminen (MN) method stratified by prior ICS use (Yes/No).||21.3|-16.0|0.7687
72606657|NCT01656395|144740877|SUPERIORITY||Mean Difference (Final Values)|-6.6||||0.4943|TWO_SIDED|95.0|-24.9|12.2|||MN Method|||Difference for AQLQ(S) Response Rate: MK-1029 30 mg vs. Placebo. P-values, estimates and 95% CIs are based on the MN method stratified by prior ICS use (Yes/No).||12.2|-24.9|0.4943
72606658|NCT01656395|144740877|SUPERIORITY||Mean Difference (Final Values)|10.5||||0.3003|TWO_SIDED|95.0|-9.4|29.6|||MN method|||Difference for AQLQ(S) Response Rate: MK-1029 60 mg vs. Placebo. P-values, estimates and 95% CIs are based on the MN method stratified by prior ICS use (Yes/No).||29.6|-9.4|0.3003
72606659|NCT01656395|144740877|SUPERIORITY||Mean Difference (Final Values)|17.5||||0.0774|TWO_SIDED|95.0|-1.9|35.7|||MN method|||Difference for AQLQ(S) Response Rate: MK-1029 150 mg vs. Placebo. P-values, estimates and 95% CIs are based on the MN method stratified by prior ICS use (Yes/No).||35.7|-1.9|0.0774
72606660|NCT01656395|144740877|SUPERIORITY||Mean Difference (Final Values)|18.2||||0.0555|TWO_SIDED|95.0|-0.4|35.5|||MN method|||Difference for AQLQ(S) Response Rate: Montelukast vs. Placebo. P-values, estimates and 95% CIs are based on the MN method stratified by prior ICS use (Yes/No).||35.5|-0.4|0.0555
72606661|NCT01656395|144740878|SUPERIORITY||Mean Difference (Final Values)|-0.104||||0.603|TWO_SIDED|95.0|-0.495|0.288|||cLDA model|||Difference in LS means for change from Baseline to Week 12 in ACQ Score: MK-1029 10 mg vs. Placebo. cLDA model includes terms for visit as categorical variable, prior ICS use (Yes/No) and treatment by visit. Negative differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).||0.288|-0.495|0.603
72606662|NCT01656395|144740878|SUPERIORITY||Mean Difference (Final Values)|-0.032||||0.875|TWO_SIDED|95.0|-0.436|0.372|||cLDA model|||Difference in LS means for change from Baseline to Week 12 in ACQ Score: MK-1029 30 mg vs. Placebo. cLDA model includes terms for visit as categorical variable, prior ICS use (Yes/No) and treatment by visit. Negative differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).||0.372|-0.436|0.875
72606663|NCT01656395|144740878|SUPERIORITY||Mean Difference (Final Values)|-0.151||||0.476|TWO_SIDED|95.0|-0.568|0.265|||cLDA model|||Difference in LS means for change from Baseline to Week 12 in ACQ Score: MK-1029 60 mg vs. Placebo. cLDA model includes terms for visit as categorical variable, prior ICS use (Yes/No) and treatment by visit. Negative differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).||0.265|-0.568|0.476
72606664|NCT01656395|144740878|SUPERIORITY||Mean Difference (Final Values)|-0.362||||0.079|TWO_SIDED|95.0|-0.767|0.042|||cLDA model|||Difference in LS means for change from Baseline to Week 12 in ACQ Score: MK-1029 150 mg vs. Placebo. cLDA model includes terms for visit as categorical variable, prior ICS use (Yes/No) and treatment by visit. Negative differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).||0.042|-0.767|0.079
72606665|NCT01656395|144740878|SUPERIORITY||Mean Difference (Final Values)|-0.227||||0.257|TWO_SIDED|95.0|-0.621|0.166|||cLDA model|||"Difference in LS means for change from Baseline to Week 12 in ACQ Score: Montelukast vs. Placebo.~cLDA model includes terms for visit as categorical variable, prior ICS use (Yes/No) and treatment by visit. Negative differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast)."||0.166|-0.621|0.257
72606666|NCT01656395|144740879|SUPERIORITY||Mean Difference (Final Values)|3.1||||0.742|TWO_SIDED|95.0|-15.1|21.1|||MN method|||Difference for change from Baseline to Week 12 in ACQ response rate: MK-1029 10 mg vs. Placebo. P-values, estimates and 95% CIs are based on the MN method stratified by prior ICS use (Yes/No).||21.1|-15.1|0.742
72606667|NCT01656395|144740879|SUPERIORITY||Mean Difference (Final Values)|-3.4||||0.7248|TWO_SIDED|95.0|-22.1|15.4|||MN method|||Difference for change from Baseline to Week 12 in ACQ response rate: MK-1029 30 mg vs. Placebo. P-values, estimates and 95% CIs are based on the MN method stratified by prior ICS use (Yes/No).||15.4|-22.1|0.7248
72606668|NCT01656395|144740879|SUPERIORITY||Mean Difference (Final Values)|3.8||||0.6991|TWO_SIDED|95.0|-15.6|22.6|||MN method|||Difference for change from Baseline to Week 12 in ACQ response rate: MK-1029 60 mg vs. Placebo. P-values, estimates and 95% CIs are based on the MN method stratified by prior ICS use (Yes/No).||22.6|-15.6|0.6991
72606669|NCT01656395|144740879|SUPERIORITY||Mean Difference (Final Values)|8.1||||0.3934|TWO_SIDED|95.0|-10.6|26.2|||MN method|||Difference for change from Baseline to Week 12 in ACQ response rate: MK-1029 150 mg vs. Placebo. P-values, estimates and 95% CIs are based on the MN method stratified by prior ICS use (Yes/No).||26.2|-10.6|0.3934
72606670|NCT01656395|144740879|SUPERIORITY||Mean Difference (Final Values)|2.3||||0.8032|TWO_SIDED|95.0|-16.0|20.5|||MN method|||Difference for change from Baseline to Week 12 in ACQ response rate: Montelukast vs. Placebo. P-values, estimates and 95% CIs are based on the MN method stratified by prior ICS use (Yes/No).||20.5|-16.0|0.8032
72606671|NCT01656395|144740880|SUPERIORITY||Mean Difference (Final Values)|-0.075||||0.873|TWO_SIDED|95.0|-1.004|0.853|||ANOVA|||Difference in LS means for percent of asthma attack days over Week 6 to Week 12 of a 12-week treatment period: MK-1209 10 mg vs. Placebo. ANOVA model includes terms for prior ICS use (Yes/No) and treatment. Negative differences are in favor of the first treatment group in the comparison (MK- 1029 or Montelukast).||0.853|-1.004|0.873
72606672|NCT01656395|144740880|SUPERIORITY||Mean Difference (Final Values)|-0.376||||0.437|TWO_SIDED|95.0|-1.326|0.575|||ANOVA|||Difference in LS means for percent of asthma attack days over Week 6 to Week 12 of a 12-week treatment period: MK-1209 30 mg vs. Placebo. ANOVA model includes terms for prior ICS use (Yes/No) and treatment. Negative differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).||0.575|-1.326|0.437
72606673|NCT01656395|144740880|SUPERIORITY||Mean Difference (Final Values)|-0.54||||0.27|TWO_SIDED|95.0|-1.504|0.423|||ANOVA|||Difference in LS means for percent of asthma attack days over Week 6 to Week 12 of a 12-week treatment period: MK-1209 60 mg vs. Placebo. ANOVA model includes terms for prior ICS use (Yes/No) and treatment. Negative differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).||0.423|-1.504|0.270
72606674|NCT01656395|144740880|SUPERIORITY||Mean Difference (Final Values)|0.079||||0.865|TWO_SIDED|95.0|-0.839|0.997|||ANOVA|||Difference in LS means for percent of asthma attack days over Week 6 to Week 12 of a 12-week treatment period: MK-1209 150 mg vs. Placebo. ANOVA model includes terms for prior ICS use (Yes/No) and treatment. Negative differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).||0.997|-0.839|0.865
72606675|NCT01656395|144740880|SUPERIORITY||Mean Difference (Final Values)|-0.309||||0.503|TWO_SIDED|95.0|-1.219|0.6|||ANOVA|||Difference in LS means for percent of asthma attack days over Week 6 to Week 12 of a 12-week treatment period: Montelukast vs. Placebo. ANOVA model includes terms for prior ICS use (Yes/No) and treatment. Negative differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).||0.600|-1.219|0.503
72606676|NCT01039467|144740936|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.0001
72606677|NCT01039467|144740937|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.0001
72606678|NCT01039467|144740938|SUPERIORITY_OR_OTHER_LEGACY|||||||0.833||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.833
72606679|NCT01039467|144740939|SUPERIORITY_OR_OTHER_LEGACY|||||||0.265||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.265
72606680|NCT01039467|144740940|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||Chi-squared|||||||<0.0001
72606681|NCT01039467|144740941|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.0001
72606682|NCT01039467|144740942|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0008||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0008
72606683|NCT01039467|144740943|SUPERIORITY_OR_OTHER_LEGACY|||||||0.053||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.053
72606684|NCT01039467|144740944|SUPERIORITY_OR_OTHER_LEGACY|||||||0.493||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.493
72606685|NCT00490035|144740999|SUPERIORITY_OR_OTHER_LEGACY||Percentage Reduction over Placebo|6.5|||=|0.261|TWO_SIDED|95.0|-5.2|16.9|||ANCOVA|||In order to control the Type I error testing was performed in sequence starting with 50 mg, then 100 mg and finally 20 mg Brivaracetam per day versus Placebo, only moving to the next test if the previous one was significant at the 5 % level.||16.9|-5.2|=0.261
72606686|NCT03519009|144741022|SUPERIORITY||Odds Ratio (OR)|3.4|||<|0.001|TWO_SIDED|95.0|1.8|6.3|||longitudinal logistic regression|||||6.3|1.8|<0.001
72606687|NCT03519009|144741023|SUPERIORITY||Odds Ratio (OR)|2.6|||<|0.001|TWO_SIDED|95.0|1.5|4.4|||longitudinal logistic regression|||||4.4|1.5|<0.001
72324979|NCT01374425|144173193|SUPERIORITY_OR_OTHER||Difference in Objective Response Rates|9.4|||||TWO_SIDED|95.0|7.2|26.1|||||The difference was calculated as the percentage of participants with objective response in the Bevacizumab + FOLFIRI arm minus the Bevacizumab + mFOLFOX6 arm. The 95% CI was computed using normal approximation to the binomial distribution.|||26.1|7.2|
72416765|NCT04124926|144344218|NON_INFERIORITY|The noninferiority of each dose group of vonoprazan to lansoprazole was evaluated with a Farrington and Manning test with a noninferiority margin of 10 percentage points for the difference in maintenance of healing rates between treatments (vonoprazan minus lansoprazole).|difference in percentage|7.2|||<|0.0001|TWO_SIDED|95.0|0.21|14.09||2-sided p-value.|Farrington and Manning test||The 2-sided 95% CI of the difference in EE maintenance rates between each vonoprazan group and lansoprazole group was calculated via the Miettinen and Nurminen method.|||14.09|0.21|<0.0001
72416766|NCT04124926|144344218|SUPERIORITY|The superiority of the vonoprazan 20 mg group to lansoprazole group p-value was evaluated with a Farrington and Manning test with the null hypothesis difference ≤0 versus the alternative hypothesis difference \>0.||||||0.0136||||||2-sided p-value.|Farrington and Manning test|||||||0.0136
72324980|NCT01374425|144173194|SUPERIORITY_OR_OTHER||Difference in Objective Response Rates|2.1|||||TWO_SIDED|95.0|-9.9|14.1|||||The difference was calculated as the percentage of participants with objective response in the Bevacizumab + FOLFIRI arm minus the Bevacizumab + mFOLFOX6 arm. The 95% CI was computed using normal approximation to the binomial distribution.|||14.1|-9.9|
72324981|NCT01374425|144173195|SUPERIORITY_OR_OTHER||Difference in Objective Response Rates|-3.7|||||TWO_SIDED|95.0|-14.0|6.6|||||The difference was calculated as the percentage of participants with objective response in the ERCC-1 High subgroup minus the ERCC-1 Low subgroup. The 95% CI was computed using normal approximation to the binomial distribution.|||6.6|-14.0|
72416767|NCT04124926|144344218|SUPERIORITY|The superiority of the vonoprazan 10 mg group to lansoprazole group p-value was evaluated with a Farrington and Manning test with the null hypothesis difference ≤0 versus the alternative hypothesis difference \>0.||||||0.0436||||||2-sided p-value.|Farrington and Manning test|||||||0.0436
72416768|NCT04124926|144344219|NON_INFERIORITY|If the lower bound of the CI was greater than -15%, noninferiority would be concluded.|difference in mean percentage|2.7|||||TWO_SIDED|95.0|-1.6|7.03|||||The 2-sided 95% CI of the difference in mean percentage of 24-hour heartburn-free days between vonoprazan 20 mg and lansoprazole 30 mg was calculated from Welch's t-test.|||7.03|-1.60|
72324982|NCT01374425|144173196|SUPERIORITY_OR_OTHER||Difference in Disease Control Rates|2.1|||||TWO_SIDED|95.0|-7.6|3.3|||||The difference was calculated as the percentage of participants with disease control in the Bevacizumab + FOLFIRI arm minus the Bevacizumab + mFOLFOX6 arm. The 95% CI was computed using normal approximation to the binomial distribution.|||3.3|-7.6|
72324983|NCT01374425|144173197|SUPERIORITY_OR_OTHER||Difference in Disease Control Rates|-8.7|||||TWO_SIDED|95.0|-19.1|1.7|||||The difference was calculated as the percentage of participants with disease control in the Bevacizumab + FOLFIRI arm minus the Bevacizumab + mFOLFOX6 arm. The 95% CI was computed using normal approximation to the binomial distribution.|||1.7|-19.1|
72324984|NCT01374425|144173198|SUPERIORITY_OR_OTHER||Difference in Disease Control Rates|2.3|||||TWO_SIDED|95.0|-3.7|8.3|||||The difference was calculated as the percentage of participants with disease control in the Bevacizumab + FOLFIRI arm minus the Bevacizumab + mFOLFOX6 arm. The 95% CI was computed using normal approximation to the binomial distribution.|||8.3|-3.7|
72324985|NCT01374425|144173199|SUPERIORITY_OR_OTHER||Difference in Disease Control Rates|-4.5|||||TWO_SIDED|95.0|-10.6|1.5|||||The difference was calculated as the percentage of participants with disease control in the ERCC-1 High subgroup minus the ERCC-1 Low subgroup. The 95% CI was computed using normal approximation to the binomial distribution.|||1.5|-10.6|
72606688|NCT03877744|144741024|NON_INFERIORITY|Non-inferiority margin of 2.5 was set prior to study initiation with a Type I error of 0.025.|Mean Difference (Final Values)|1.6873|STANDARD_ERROR_OF_MEAN|0.2558||0.0008|ONE_SIDED|97.5||2.1894|||Mixed Models Analysis|Controls technician,site,seat type;Techn. nested in site modeled as random effect;Model allowed heterogeneous variances across arms w Kenward-Roger df|Mixed model allowed the arms to have unequal variance estimates. Degrees of freedom estimated using Kenward-Rogers.|||2.1894||0.0008
72606689|NCT05209880|144741025|SUPERIORITY|||||||0.5835|||||||Wilcoxon (Mann-Whitney)|||||||0.5835
72606690|NCT04817332|144741041|SUPERIORITY||Odds Ratio (OR)|0.72||||0.008|TWO_SIDED|95.0|0.57|0.92|||Odds ratio Ordinal Logistic Regression|adjusted for the stratifying factors of age as a fixed effect and site using robust standard errors to account for clustering||||0.92|0.57|0.008
72606691|NCT04817332|144741042|SUPERIORITY||Hazard Ratio (HR)|0.87||||0.058|TWO_SIDED|95.0|0.76|1.0|||Regression, Cox|||||1.00|0.76|0.058
72606692|NCT04817332|144741045|SUPERIORITY||Hazard Ratio (HR)|0.98|||||TWO_SIDED|95.0|0.84|1.13||||||||1.13|0.84|
72606693|NCT04817332|144741047|SUPERIORITY||Rate ratio|0.93|||||TWO_SIDED|95.0|0.87|0.99||||||||0.99|0.87|
72606694|NCT04817332|144741048|SUPERIORITY||Rate ratio|1.13|||||TWO_SIDED|95.0|0.73|1.74||||||||1.74|0.73|
72606695|NCT04817332|144741049|SUPERIORITY||Rate ratio|0.84|||||TWO_SIDED|95.0|0.69|1.04||||||||1.04|0.69|
72606696|NCT04817332|144741050|SUPERIORITY||Rate ratio|1.68|||||TWO_SIDED|95.0|1.09|2.58||||||||2.58|1.09|
72606697|NCT04817332|144741051|SUPERIORITY||Rate ratio|1.03|||||TWO_SIDED|95.0|0.92|1.15||||||||1.15|0.92|
72606698|NCT04817332|144741052|SUPERIORITY||Hazard Ratio (HR)|1.41|||||TWO_SIDED|95.0|1.06|1.88||||||||1.88|1.06|
72606699|NCT04817332|144741066|SUPERIORITY||Mean Difference (Final Values)|-67.0|||||TWO_SIDED|95.0|-102.0|-31.0||||||||-31|-102|
72324986|NCT01374425|144173200|SUPERIORITY_OR_OTHER||Difference in Resection Rates|-4.0|||||TWO_SIDED|95.0|-15.9|7.8|||||The difference was calculated as the percentage of participants with resection in the Bevacizumab + FOLFIRI arm minus the Bevacizumab + mFOLFOX6 arm. The 95% CI was computed using normal approximation to the binomial distribution.|||7.8|-15.9|
72606700|NCT04817332|144741070|SUPERIORITY||Mean Difference (Final Values)|0.003|||||TWO_SIDED|95.0|-0.06|0.066||||||||0.066|-0.06|
72606701|NCT04795466|144741077|SUPERIORITY||Least square mean difference|0.069|STANDARD_ERROR_OF_MEAN|0.1442||0.6386|TWO_SIDED|90.0|-0.178|0.316|||Mixed Models Analysis|||NTB Total z-score - day 171||0.316|-0.178|0.6386
72606702|NCT04795466|144741078|SUPERIORITY||Least squares mean difference|-0.002|STANDARD_ERROR_OF_MEAN|0.1739||0.9917|TWO_SIDED|90.0|-0.3|0.296|||Mixed Models Analysis|||Memory function - day 171||0.296|-0.300|0.9917
72606703|NCT04795466|144741079|SUPERIORITY||least squares mean difference|0.186|STANDARD_ERROR_OF_MEAN|0.1958||0.351|TWO_SIDED|90.0|-0.148|0.52|||Mixed Models Analysis|||Executive function- day 171||0.520|-0.148|0.3510
72606704|NCT04795466|144741080|SUPERIORITY||Repeated measures analysis|-0.49|STANDARD_ERROR_OF_MEAN|1.8||0.787|TWO_SIDED|90.0|-3.56|2.58|||Mixed Models Analysis|||DSST - day 171||2.58|-3.56|0.7870
72606705|NCT04195061|144741126|SUPERIORITY|||||||0.303|||||||t-test, 2 sided|||||||0.303
72606706|NCT04195061|144741127|SUPERIORITY|||||||0.035|||||||t-test, 2 sided|||||||0.035
72606707|NCT04195061|144741128|SUPERIORITY|||||||0.007|||||||t-test, 2 sided|||||||0.007
72606708|NCT00196105|144741134|SUPERIORITY_OR_OTHER|||||||0.057||95.0|||||Log Rank|||||||.057
72606709|NCT00196105|144741135|SUPERIORITY_OR_OTHER|||||||0.04||95.0|||||Chi-squared|||||||.04
72606710|NCT00196105|144741135|SUPERIORITY_OR_OTHER|||||||0.007||95.0||||Death is censored for Kaplan-Meier analysis.|Log Rank|||||||.007
72606711|NCT00196105|144741135|SUPERIORITY_OR_OTHER|||||||0.69||95.0|||||Chi-squared|||||||.69
72606712|NCT00196105|144741135|SUPERIORITY_OR_OTHER|||||||0.02||95.0||||P-value is adjusted for multiple comparisons.|Chi-squared|||6 mm Zilver vs. 10 mm Zilver and 10 mm Wallstent combined||||.02
72606713|NCT00196105|144741136|SUPERIORITY_OR_OTHER|||||||0.16||95.0|||||ANOVA|||||||.16
72606714|NCT00196105|144741138|SUPERIORITY_OR_OTHER|||||||0.32||95.0|||||Log Rank|||||||.32
72606715|NCT00196105|144741138|SUPERIORITY_OR_OTHER|||||||0.69||95.0|||||Kruskal-Wallis|||||||.69
72606716|NCT04863872|144741139|OTHER|Difference|Risk Ratio (RR)|0.72||||0.27|TWO_SIDED|95.0|0.39|1.3|||Poisson regression|Poisson regression with binary primary outcome, estimated using Generalized Estimating Equations (GEE) and robust variance estimation.||||1.30|0.39|0.27
72606717|NCT02864407|144741208|OTHER||||||<|0.0001||||||p-value for difference of Follow-up Week 24 (±2weeks) versus Baseline.|Paired t-test|||||||<0.0001
72606718|NCT02864407|144741209|OTHER||||||<|0.0001||||||p-value for difference of Week 52 (±2 weeks) versus Baseline.|Paired t-test|||||||<0.0001
72606719|NCT02864407|144741210|OTHER||||||<|0.0001||||||p-value for difference of Follow-up Week 24 (±2weeks) versus Baseline.|Paired t-test|||||||<0.0001
72606720|NCT02864407|144741211|OTHER||||||<|0.0001||||||p-value for difference of Follow-up Week 52 (±2weeks) versus Baseline.|Paired t-test|||||||<0.0001
72606721|NCT02864407|144741212|OTHER||||||<|0.0001|||||||Paired t-test|p-value for difference of Follow-up Week 24 (±2weeks) versus Baseline.||||||<0.0001
72606722|NCT02864407|144741213|OTHER||||||<|0.0001|||||||Paired t-test|p-value for difference of Follow-up Week 52 (±2weeks) versus Baseline.||||||<0.0001
72606723|NCT02864407|144741214|OTHER||||||<|0.0001|||||||Paired t-test|p-value for difference of Follow-up Week 24 (±2weeks) versus Baseline.||||||<0.0001
72606724|NCT02864407|144741215|OTHER||||||<|0.0001|||||||Paired t-test|p-value for difference of Follow-up Week 52 (±2weeks) versus Baseline.||||||<0.0001
72606725|NCT02864407|144741216|OTHER||||||<|0.0001||||||p-value for difference of Week 24 (±2 weeks) versus Baseline.|Paired t-test|||||||<0.0001
72606726|NCT02864407|144741217|OTHER||||||<|0.0001||||||p-value for difference of 52±2 weeks versus Baseline.|Paired t-test|||||||<0.0001
72606727|NCT02864407|144741218|OTHER||||||<|0.0001||||||p-value for difference of Week 24 (±2 weeks) versus Baseline.|Paired t-test|||||||<0.0001
72606728|NCT02864407|144741219|OTHER||||||<|0.0001||||||p-value for difference of Week 52 (±2 weeks) versus Baseline.|Paired t-test|||||||<0.0001
72606729|NCT04577794|144741224|SUPERIORITY||Least square (LS) mean difference|0.0|STANDARD_ERROR_OF_MEAN|1.02||0.981|TWO_SIDED|90.0|-1.7|1.7|||ANCOVA|||An analysis of covariance (ANCOVA) was used with a multiple imputation method to handle missing values, with treatment as fixed effect and baseline score as covariate.||1.7|-1.7|0.981
72606730|NCT02849080|144741227|SUPERIORITY|This hypothesis was controlled for multiplicity. Results are based on the data from the in-trial observation period. The estimated treatment effect includes the effect of any rescue medication and any effect after premature trial product discontinuation (treatment policy estimand).|Odds Ratio (OR)|4.4|||<|0.0001|TWO_SIDED|95.0|2.89|6.7||Unadjusted two-sided p-value for test of no difference from 1.|Pattern mixture model||Oral Semaglutide flex / Sitagliptin 100 mg.|The analysis was based on a pattern mixture model using multiple imputation to handle missing week 52 data, assuming that data were missing at random within the groups used for imputation. The imputed data sets were analysed using a logistic regression model with treatment, strata, and region as categorical fixed effects and baseline HbA1c value as covariate for each of the 1000 imputed complete datasets, and pooled by Rubin's rule to draw inference.||6.70|2.89|<0.0001
72606731|NCT02849080|144741227|SUPERIORITY|This hypothesis was not controlled for multiplicity. Results are based on the data from the on-treatment without rescue medication observation period. The estimated treatment effect excludes the effect of any rescue medication and any effect after premature trial product discontinuation (hypothetical estimand).|Odds Ratio (OR)|5.54|||<|0.0001|TWO_SIDED|95.0|3.54|8.68||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Logistic||Oral Semaglutide flex / Sitagliptin 100 mg|The analysis was based on multiple imputation, imputing sequentially using post-baseline measurements up to and including week 52. The imputed data sets were analysed using a logistic regression model with treatment, strata, and region as categorical fixed effects and baseline HbA1c value as covariate for each of the 1000 imputed complete datasets, and pooled by Rubin's rule to draw inference.||8.68|3.54|<0.0001
72324987|NCT01374425|144173201|SUPERIORITY_OR_OTHER||Difference in Complete Resection Rates|-6.5|||||TWO_SIDED|95.0|-16.3|3.3|||||The difference was calculated as the percentage of participants with complete resection in the Bevacizumab + FOLFIRI arm minus the Bevacizumab + mFOLFOX6 arm. The 95% CI was computed using normal approximation to the binomial distribution.|||3.3|-16.3|
72606732|NCT02849080|144741228|SUPERIORITY|This hypothesis was controlled for multiplicity. Results are based on the data from the in-trial observation period. The estimated treatment effect includes the effect of any rescue medication and any effect after premature trial product discontinuation (treatment policy estimand).|Treatment difference|-1.9|||<|0.0001|TWO_SIDED|95.0|-2.6|-1.2||Unadjusted two-sided p-value for test of no difference from 0.|Pattern mixture model||Oral semaglutide flex - Sitagliptin 100 mg|The analysis was based on a pattern mixture model using multiple imputation to handle missing week 52 data, assuming that data were missing at random within the groups used for imputation. The imputed data sets were analysed using a logistic regression model with treatment, strata, and region as categorical fixed effects and baseline HbA1c value as covariate for each of the 1000 imputed complete datasets, and pooled by Rubin's rule to draw inference.||-1.2|-2.6|<0.0001
72606733|NCT02849080|144741228|SUPERIORITY|This hypothesis was not controlled for multiplicity. Results are based on the data from the on-treatment without rescue medication observation period. The estimated treatment effect excludes the effect of any rescue medication and any effect after premature trial product discontinuation (hypothetical estimand).|Treatment difference|-2.2|||<|0.0001|TWO_SIDED|95.0|-2.9|-1.5||Unadjusted two-sided p-value for test of no difference from 0.|Mixed model for repeated measurements||Oral semaglutide flex - Sitagliptin 100 mg|The analysis was based on a Mixed model for repeated measurements (MMRM) that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 52. The independent effects were treatment, strata and region as categorical fixed effects and the baseline HbA1c value as a covariate, all nested within visit, and an unstructured residual covariance matrix.||-1.5|-2.9|<0.0001
72606734|NCT02849080|144741245|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|0.18|||<|0.0001|TWO_SIDED|95.0|0.09|0.39||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox||Oral semaglutide flex / Sitagliptin 100 mg|Time to initiation of rescue medication was analysed using a Cox proportional hazards model with treatment, strata, and region as categorical fixed effects and baseline HbA1c as covariate. Censoring time was one day before last day on trial product.||0.39|0.09|<0.0001
72606735|NCT02849080|144741246|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|0.58||||0.0175|TWO_SIDED|95.0|0.37|0.91||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox||Oral Semaglutide flex / Sitagliptin 100 mg|Time to initiation of additional anti-diabetic medication was analysed using a Cox proportional hazards model with treatment, strata, and region as categorical fixed effects and baseline HbA1c as covariate. Censoring time was one day before planned end of treatment.||0.91|0.37|0.0175
72606736|NCT02849080|144741265|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|0.77||||0.4381|TWO_SIDED|95.0|0.39|1.5||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox||Oral Semaglutide flex- Switch / Sitagliptin 100 mg- Switch|Time to initiation of additional anti-diabetic medication was analysed using a Cox proportional hazards model with treatment, strata, and region as categorical fixed effects and baseline HbA1c as covariate. Censoring time was one day before planned end of treatment.||1.50|0.39|0.4381
72606737|NCT02849080|144741266|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|0.47||||0.079|TWO_SIDED|95.0|0.2|1.09||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox||Oral semaglutide flex- Switch / Sitagliptin 100 mg- Switch|Time to initiation of rescue medication was analysed using a Cox proportional hazards model with treatment, strata, and region as categorical fixed effects and baseline HbA1c as covariate. Censoring time was one day before last day on trial product.||1.09|0.20|0.0790
72606738|NCT03839394|144741309|OTHER|||||||0.012|||||||t-test, 2 sided|||This was a pilot study positioned to determine the effect size of a clinic-based intervention that has not been evaluated previously. Therefore, sample size was determined to be adequate to discern an effect size, but not powered to determine definitive statistical significance.||||0.012
72606739|NCT03839394|144741310|OTHER|||||||0.05|||||||Z-test of Proportions|||This was a pilot study positioned to determine the effect size of a clinic-based intervention that has not been evaluated previously. Therefore, sample size was determined to be adequate to discern an effect size, but not powered to determine definitive statistical significance.||||0.05
72606740|NCT03839394|144741311|OTHER|||||||0.75|||||||t-test, 2 sided|||This was a pilot study positioned to determine the effect size of a clinic-based intervention that has not been evaluated previously. Therefore, sample size was determined to be adequate to discern an effect size, but not powered to determine definitive statistical significance.||||0.750
72324988|NCT01374425|144173202|SUPERIORITY_OR_OTHER||Difference in Resection Rates|-11.0|||||TWO_SIDED|95.0|-33.1|11.1|||||The difference was calculated as the percentage of participants with resection in the Bevacizumab + FOLFIRI arm minus the Bevacizumab + mFOLFOX6 arm. The 95% CI was computed using normal approximation to the binomial distribution.|||11.1|-33.1|
72606741|NCT03839394|144741312|OTHER|||||||0.86|||||||t-test, 2 sided|||This was a pilot study positioned to determine the effect size of a clinic-based intervention that has not been evaluated previously. Therefore, sample size was determined to be adequate to discern an effect size, but not powered to determine definitive statistical significance.||||0.860
72606742|NCT03839394|144741313|OTHER|||||||0.76|||||||t-test, 2 sided|||This was a pilot study positioned to determine the effect size of a clinic-based intervention that has not been evaluated previously. Therefore, sample size was determined to be adequate to discern an effect size, but not powered to determine definitive statistical significance.||||0.760
72324989|NCT01374425|144173203|SUPERIORITY_OR_OTHER||Difference in Complete Resection Rates|-11.0|||||TWO_SIDED|95.0|-33.1|11.1|||||The difference was calculated as the percentage of participants with complete resection in the Bevacizumab + FOLFIRI arm minus the Bevacizumab + mFOLFOX6 arm. The 95% CI was computed using normal approximation to the binomial distribution.|||11.1|-33.1|
72324990|NCT01374425|144173204|SUPERIORITY_OR_OTHER||Difference in Resection Rates|-3.0|||||TWO_SIDED|95.0|-10.1|4.2|||||The difference was calculated as the percentage of participants with resection in the Bevacizumab + FOLFIRI arm minus the Bevacizumab + mFOLFOX6 arm. The 95% CI was computed using normal approximation to the binomial distribution.|||4.2|-10.1|
72324991|NCT01374425|144173205|SUPERIORITY_OR_OTHER||Difference in Complete Resection Rates|-5.5|||||TWO_SIDED|95.0|-11.5|0.4|||||The difference was calculated as the percentage of participants with complete resection in the Bevacizumab + FOLFIRI arm minus the Bevacizumab + mFOLFOX6 arm. The 95% CI was computed using normal approximation to the binomial distribution.|||0.4|-11.5|
72324992|NCT01374425|144173206|SUPERIORITY_OR_OTHER||Difference in Resection Rates|-4.4|||||TWO_SIDED|95.0|-9.5|0.6|||||The difference was calculated as the percentage of participants with resection in the ERCC-1 High subgroup minus the ERCC-1 Low subgroup. The 95% CI was computed using normal approximation to the binomial distribution.|||0.6|-9.5|
72324993|NCT01374425|144173207|SUPERIORITY_OR_OTHER||Difference in Complete Resection Rates|-1.6|||||TWO_SIDED|95.0|-6.2|3.1|||||The difference was calculated as the percentage of participants with complete resection in the ERCC-1 High subgroup minus the ERCC-1 Low subgroup. The 95% CI was computed using normal approximation to the binomial distribution.|||3.1|-6.2|
72324994|NCT01374425|144173208|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.29||||0.0593|TWO_SIDED|95.0|0.99|1.69||P-value (relative to KRAS Wild-Type subgroup) based on two-sided stratified log rank test and not adjusted for multiple comparisons.|Log Rank||HR (relative to KRAS Wild-Type subgroup) was estimated by Cox regression.|Analysis stratified by high/low ERCC-1 level and region of enrollment.||1.69|0.99|0.0593
72324995|NCT01374425|144173209|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.64||||0.002|TWO_SIDED|95.0|1.2|2.24||P-value (relative to VEGF-A Low subgroup) based on two-sided stratified log rank test and not adjusted for multiple comparisons.|Log Rank||HR (relative to VEGF-A Low subgroup) was estimated by Cox regression.|Analysis stratified by high/low ERCC-1 level and region of enrollment.||2.24|1.20|0.0020
72324996|NCT01374425|144173210|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.34||||0.0955|TWO_SIDED|95.0|0.95|1.88||P-value (relative to KRAS Wild-Type subgroup) based on two-sided stratified log rank test and not adjusted for multiple comparisons.|Log Rank||HR (relative to KRAS Wild-Type subgroup) was estimated by Cox regression.|Analysis stratified by high/low ERCC-1 level and region of enrollment.||1.88|0.95|0.0955
72324997|NCT01374425|144173211|SUPERIORITY_OR_OTHER||Difference in Objective Response Rates|-5.9|||||TWO_SIDED|95.0|-15.7|3.8|||||The difference was calculated as the percentage of participants with objective response in the VEGF-A High subgroup minus the VEGF-A Low subgroup. The 95% CI was computed using normal approximation to the binomial distribution.|||3.8|-15.7|
72324998|NCT01374425|144173212|SUPERIORITY_OR_OTHER||Difference in Objective Response Rates|-5.4|||||TWO_SIDED|95.0|-16.0|5.2|||||The difference was calculated as the percentage of participants with objective response in the KRAS Mutant subgroup minus the KRAS Wild-Type subgroup. The 95% CI was computed using normal approximation to the binomial distribution.|||5.2|-16.0|
72324999|NCT01374425|144173213|SUPERIORITY_OR_OTHER||Difference in Disease Control Rates|-1.1|||||TWO_SIDED|95.0|-6.5|4.3|||||The difference was calculated as the percentage of participants with disease control in the VEGF-A High subgroup minus the VEGF-A Low subgroup. The 95% CI was computed using normal approximation to the binomial distribution.|||4.3|-6.5|
72416769|NCT04124926|144344220|SUPERIORITY|The superiority of the vonoprazan 20 mg group to lansoprazole group p-value was evaluated with a Farrington and Manning test with the null hypothesis difference ≤0 versus the alternative hypothesis difference \>0.|difference in percentage|17.6||||0.0008|TWO_SIDED|95.0|7.44|27.43||2-sided p-value.|Farrington and Manning test||The 2-sided 95% CI of the difference in EE healing rates between vonoprazan 20 mg and lansoprazole 30 mg was calculated via the Miettinen and Nurminen method.|||27.43|7.44|0.0008
72325000|NCT01374425|144173214|SUPERIORITY_OR_OTHER||Difference in Resection Rates|-3.2|||||TWO_SIDED|95.0|-8.6|2.1|||||The difference was calculated as the percentage of participants with resection in the VEGF-A High subgroup minus the VEGF-A Low subgroup. The 95% CI was computed using normal approximation to the binomial distribution.|||2.1|-8.6|
72325001|NCT01374425|144173215|SUPERIORITY_OR_OTHER||Difference in Complete Resection Rates|-4.9|||||TWO_SIDED|95.0|-9.6|-0.2|||||The difference was calculated as the percentage of participants with complete resection in the VEGF-A High subgroup minus the VEGF-A Low subgroup. The 95% CI was computed using normal approximation to the binomial distribution.|||-0.2|-9.6|
72325002|NCT01227057|144173216|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were based on the SI-R using effect size estimates from a previous trial comparing individual CBT with a Wait List (WL) control (Steketee2010). In this study, the effect size of Cognitive Behavioral Therapy (CBT) relative to WL was d = 2.21 on the SI-R. Accounting for a smaller effect size due to having an active control condition, we expected to have 80% power to detect a large (d = .80) effect size. The sample assessed for eligibility (n = 67) was 99% of this target.||||||0.029||||||P value is for the group x time interaction.|Mixed Models Analysis|Adjusted for age, years of education, and presence of co-morbid obsessive-compulsive disorder due to group differences at baseline.||Linear mixed models with random intercepts were used to evaluate the change in primary and secondary outcome variables over time, the effect of group, the effect of treatment, and the treatment group by time interaction, both for the treatment phase (0-6 months) and follow up phase (6-12 months). All analyses (0-6 months) were conducted first using observed data only (i.e., completer analysis) and then using an intent to treat (ITT) sample.||||.029
72325003|NCT01227057|144173217|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were based on the SI-R using effect size estimates from a previous trial comparing individual CBT with a Wait List (WL) control (Steketee2010). In this study, the effect size of Cognitive Behavioral Therapy (CBT) relative to WL was d = 2.21 on the SI-R. Accounting for a smaller effect size due to having an active control condition, we expected to have 80% power to detect a large (d = .80) effect size. The sample assessed for eligibility (n = 67) was 99% of this target.||||||0.04||||||P value is for the group x time interaction.|Mixed Models Analysis|Adjusted for age, years of education, and presence of co-morbid obsessive-compulsive disorder due to group differences at baseline.||Linear mixed models with random intercepts were used to evaluate the change in primary and secondary outcome variables over time, the effect of group, the effect of treatment, and the treatment group by time interaction, both for the treatment phase (0-6 months) and follow up phase (6-12 months). All analyses (0-6 months) were conducted first using observed data only (i.e., completer analysis) and then using an intent to treat (ITT) sample.||||.04
72606743|NCT00593450|144741322|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority limit for the difference between study groups in the mean change in visual acuity at 1 year was 5 letters (i.e., one line on the Early Treatment Diabetic Retinopathy Study \[ETDRS\] visual-acuity chart)|Mean Difference (Net)|-0.5|STANDARD_ERROR_OF_MEAN|1.7||0.16|TWO_SIDED|99.2|-3.9|2.9||This p-value is for the test of overall difference among 4 treatment groups. The p-value for pairwise comparison was not performed, because this is a non-inferiority trial.|ANOVA|We calcularted of two-sided 99.2% confidence intervals. We used Bonferroni approach to accommodate six pairwise treatment comparisons.|Estimate = Mean VA Change in Avastin Monthly Group - Mean VA Change in Lucentis Monthly Group|The study was designed as a non-inferiority trial among four study groups, with the ability to test for superiority if a treatment was found to be non-inferior. Assuming a standard deviation for changes in visual acuity for 15 letters, we determined that a sample of 277 patients per group (which was increased to 300 to allow for a rate of death or dropout of 8%) would provide a power of 90%.||2.9|-3.9|0.16
72606744|NCT00593450|144741322|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority limit for the difference between study groups in the mean change in visual acuity at 1 year was 5 letters (i.e., one line on the Early Treatment Diabetic Retinopathy Study \[ETDRS\] visual-acuity chart)|Mean Difference (Net)|-0.8|STANDARD_ERROR_OF_MEAN|1.6||0.16|TWO_SIDED|99.2|-4.1|2.4||This p-value is for the test of overall difference among 4 treatment groups. The p-value for pairwise comparison was not performed, because this is a non-inferiority trial.|ANOVA|We calcularted of two-sided 99.2% confidence intervals. We used Bonferroni approach to accommodate six pairwise treatment comparisons.|Estimate = Mean VA Change in Avastin as Needed Group - Mean VA Change in Lucentis as Needed Group|The study was designed as a non-inferiority trial among four study groups, with the ability to test for superiority if a treatment was found to be non-inferior. Assuming a standard deviation for changes in visual acuity for 15 letters, we determined that a sample of 277 patients per group (which was increased to 300 to allow for a rate of death or dropout of 8%) would provide a power of 90%.||2.4|-4.1|0.16
72606745|NCT00593450|144741322|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority limit for the difference between study groups in the mean change in visual acuity at 1 year was 5 letters (i.e., one line on the Early Treatment Diabetic Retinopathy Study \[ETDRS\] visual-acuity chart)|Mean Difference (Net)|-1.7|STANDARD_ERROR_OF_MEAN|1.5||0.16|TWO_SIDED|99.2|-4.7|1.3||This p-value is for the test of overall difference among 4 treatment groups. The p-value for pairwise comparison was not performed, because this is a non-inferiority trial.|ANOVA|We calcularted of two-sided 99.2% confidence intervals. We used Bonferroni approach to accommodate six pairwise treatment comparisons.|Estimate = Mean VA Change in Lucentis as Needed Group - Mean VA Change in Lucentis Monthly Group|The study was designed as a non-inferiority trial among four study groups, with the ability to test for superiority if a treatment was found to be non-inferior. Assuming a standard deviation for changes in visual acuity for 15 letters, we determined that a sample of 277 patients per group (which was increased to 300 to allow for a rate of death or dropout of 8%) would provide a power of 90%.||1.3|-4.7|0.16
72606746|NCT00593450|144741322|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority limit for the difference between study groups in the mean change in visual acuity at 1 year was 5 letters (i.e., one line on the Early Treatment Diabetic Retinopathy Study \[ETDRS\] visual-acuity chart)|Mean Difference (Net)|-2.1|STANDARD_ERROR_OF_MEAN|1.9||0.16|TWO_SIDED|99.2|-5.7|1.6||This p-value is for the test of overall difference among 4 treatment groups. The p-value for pairwise comparison was not performed, because this is a non-inferiority trial.|ANOVA|We calcularted of two-sided 99.2% confidence intervals. We used Bonferroni approach to accommodate six pairwise treatment comparisons.|Estimate = Mean VA Change in Avastin as Needed Group - Mean VA Change in Avastin Monthly Group|The study was designed as a non-inferiority trial among four study groups, with the ability to test for superiority if a treatment was found to be non-inferior. Assuming a standard deviation for changes in visual acuity for 15 letters, we determined that a sample of 277 patients per group (which was increased to 300 to allow for a rate of death or dropout of 8%) would provide a power of 90%.||1.6|-5.7|0.16
72325004|NCT01227057|144173218|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were based on the SI-R using effect size estimates from a previous trial comparing individual CBT with a Wait List (WL) control (Steketee2010). In this study, the effect size of Cognitive Behavioral Therapy (CBT) relative to WL was d = 2.21 on the SI-R. Accounting for a smaller effect size due to having an active control condition, we expected to have 80% power to detect a large (d = .80) effect size. The sample assessed for eligibility (n = 67) was 99% of this target.|||||>|0.1||||||P value is for the group x time interaction.|ANOVA|||||||>.1
72416770|NCT04124926|144344221|SUPERIORITY|The superiority of the vonoprazan 20 mg group to lansoprazole group p-value was evaluated with a Farrington and Manning test with the null hypothesis difference ≤0 versus the alternative hypothesis difference \>0.|difference in percentage|2.3||||0.4392|TWO_SIDED|95.0|-3.5|8.04||2-sided p-value.|Farrington and Manning test||The 2-sided 95% CI of the difference in sustained resolution rates between vonoprazan 20 mg and lansoprazole 30 mg was calculated via the Miettinen and Nurminen method.|||8.04|-3.50|0.4392
72416771|NCT04124926|144344222|SUPERIORITY|Observed p-value and not a formal test per the preplanned fixed-sequence testing procedure. The superiority of the vonoprazan 20 mg group to lansoprazole group p-value was evaluated with a Farrington and Manning test with the null hypothesis difference ≤0 versus the alternative hypothesis difference \>0.|difference in percentage|19.6|||<|0.0001|TWO_SIDED|95.0|11.84|27.58||2-sided p-value.|Farrington and Manning test||The 2-sided 95% CI of the difference in EE healing rates between vonoprazan 20 mg and lansoprazole 30 mg was calculated via the Miettinen and Nurminen method.|||27.58|11.84|<0.0001
72325005|NCT02271529|144173219|NON_INFERIORITY_OR_EQUIVALENCE|Under the assumption that the mean percent change in stent length upon deployment being 0.2% with a standard deviation of 4%, type I error of 0.05, and two one-sided t-tests, a sample size of at least 30 stents provides power \> 0.90 to determine that the mean length change of stents deployed with the thumbwheel delivery system is within +/-10%.|Mean percent change|-1.0|||<|0.01|TWO_SIDED|95.0|-1.5|-0.4|||two one-sided t-tests|||||-0.4|-1.5|<0.01
72325006|NCT01240863|144173220|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.35||||0.134|TWO_SIDED|95.0|-0.11|0.82||statistical significance level of 0.05.|ANCOVA|Treatment and stratification (opioid naïve/opioid experienced) factors as the fixed effects; screening and baseline APIs as covariates.|placebo - hydrocodone|||0.82|-0.11|0.134
72325007|NCT01419119|144173246|SUPERIORITY|||||||0.001|||||||t-test, 2 sided|||||||0.001
72325008|NCT01419119|144173247|SUPERIORITY|||||||0.001|||||||t-test, 2 sided|||||||0.001
72606747|NCT00593450|144741322|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority limit for the difference between study groups in the mean change in visual acuity at 1 year was 5 letters (i.e., one line on the Early Treatment Diabetic Retinopathy Study \[ETDRS\] visual-acuity chart)|Mean Difference (Net)|-1.2|STANDARD_ERROR_OF_MEAN|1.7||0.16|TWO_SIDED|99.2|-4.5|2.1||This p-value is for the test of overall difference among 4 treatment groups. The p-value for pairwise comparison was not performed, because this is a non-inferiority trial.|ANOVA|We calcularted of two-sided 99.2% confidence intervals. We used Bonferroni approach to accommodate six pairwise treatment comparisons.|Estimate = Mean VA Change in Lucentis as Needed Group - Mean VA Change in Avastin Monthly Group|The study was designed as a non-inferiority trial among four study groups, with the ability to test for superiority if a treatment was found to be non-inferior. Assuming a standard deviation for changes in visual acuity for 15 letters, we determined that a sample of 277 patients per group (which was increased to 300 to allow for a rate of death or dropout of 8%) would provide a power of 90%.||2.1|-4.5|0.16
72606748|NCT00593450|144741322|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority limit for the difference between study groups in the mean change in visual acuity at 1 year was 5 letters (i.e., one line on the Early Treatment Diabetic Retinopathy Study \[ETDRS\] visual-acuity chart)|Mean Difference (Net)|-2.6|STANDARD_ERROR_OF_MEAN|1.7||0.16|TWO_SIDED|99.2|-5.9|0.8||This p-value is for the test of overall difference among 4 treatment groups. The p-value for pairwise comparison was not performed, because this is a non-inferiority trial.|ANOVA|We calcularted of two-sided 99.2% confidence intervals. We used Bonferroni approach to accommodate six pairwise treatment comparisons.|Estimate = Mean VA Change in Avastin as Needed Group - Mean VA Change in Lucentis Monthly Group|The study was designed as a non-inferiority trial among four study groups, with the ability to test for superiority if a treatment was found to be non-inferior. Assuming a standard deviation for changes in visual acuity for 15 letters, we determined that a sample of 277 patients per group (which was increased to 300 to allow for a rate of death or dropout of 8%) would provide a power of 90%.||0.8|-5.9|0.16
72606749|NCT02358031|144741337|SUPERIORITY||Hazard Ratio (HR)|0.93||||0.21211|TWO_SIDED|95.0|0.78|1.11||One-sided p-value based on log-rank test stratified by ECOG, HPV status and PD-L1 status.|Regression, Cox|||PFS in all participants of the pembro combo arm was compared to PFS in all participants of the control arm to address the sixth primary hypothesis. The comparison was based on a Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG, HPV status and PD-L1 status.||1.11|0.78|0.21211
72606750|NCT02358031|144741338|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.03697|TWO_SIDED|95.0|0.69|1.02||One-sided p-value based on log-rank test stratified by ECOG, HPV status and PD-L1 status.|Regression, Cox|||PFS in CPS ≥1 participants of the pembro combo arm was compared to PFS in CPS ≥1 participants of the control arm to address the fifth primary hypothesis. The comparison was based on a Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG, HPV status and PD-L1 status.||1.02|0.69|0.03697
72606751|NCT02358031|144741339|SUPERIORITY||Hazard Ratio (HR)|0.76||||0.02951|TWO_SIDED|95.0|0.58|1.01||One-sided p-value based on log-rank test stratified by ECOG and HPV status.|Regression, Cox|||PFS in CPS ≥20 participants of the pembro combo arm was compared to PFS in CPS ≥20 participants of the control arm to address the fourth primary hypothesis. The comparison was based on a Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG and HPV status.||1.01|0.58|0.02951
72606752|NCT02358031|144741340|SUPERIORITY||Hazard Ratio (HR)|0.72||||0.00025|TWO_SIDED|95.0|0.6|0.87||One-sided p-value based on log-rank test stratified by ECOG, HPV status and PD-L1 status.|Regression, Cox|||OS in all participants of the pembro combo arm was compared to OS in all participants of the control arm to address the fourteenth primary hypothesis. The comparison was based on a Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG, HPV status and PD-L1 status.||0.87|0.60|0.00025
72606753|NCT02358031|144741341|SUPERIORITY||Hazard Ratio (HR)|0.65||||2e-05|TWO_SIDED|95.0|0.53|0.8||One-sided p-value based on log-rank test stratified by ECOG, HPV status and PD-L1 status.|Regression, Cox|||OS in CPS ≥1 participants of the pembro combo arm was compared to OS in CPS ≥1 participants of the control arm to address the twelfth primary hypothesis. The comparison was based on a Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG, HPV status and PD-L1 status.||0.80|0.53|0.00002
72606754|NCT02358031|144741342|SUPERIORITY||Hazard Ratio (HR)|0.6||||0.00044|TWO_SIDED|95.0|0.45|0.82||One-sided p-value based on log-rank test stratified by ECOG and HPV status.|Regression, Cox|||OS in CPS ≥20 participants of the pembro combo arm was compared to OS in CPS ≥20 participants of the control arm to address the eleventh primary hypothesis. The comparison was based on a Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG and HPV status.||0.82|0.45|0.00044
72606755|NCT02358031|144741343|SUPERIORITY||Hazard Ratio (HR)|1.29||||0.9983|TWO_SIDED|95.0|1.09|1.53||One-sided p-value based on log-rank test stratified by ECOG, HPV status and PD-L1 status.|Regression, Cox|||PFS in all participants of the pembro mono arm was compared to PFS in all participants of the control arm to address the third primary hypothesis. The comparison was based on a Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG, HPV status and PD-L1 status.||1.53|1.09|0.99830
72606756|NCT02358031|144741344|SUPERIORITY||Hazard Ratio (HR)|1.13||||0.8958|TWO_SIDED|95.0|0.94|1.36||One-sided p-value based on log-rank test stratified by ECOG, HPV status and PD-L1 status.|Regression, Cox|||PFS in CPS ≥1 participants of the pembro mono arm was compared to PFS in CPS ≥1 participants of the control arm to address the second primary hypothesis. The comparison was based on a Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG, HPV status and PD-L1 status.||1.36|0.94|0.89580
72606757|NCT02358031|144741345|SUPERIORITY||Hazard Ratio (HR)|0.99||||0.46791|TWO_SIDED|95.0|0.76|1.29||One-sided p-value based on log-rank test stratified by ECOG and HPV status.|Regression, Cox|||PFS in CPS ≥20 participants of the pembro mono arm was compared to PFS in CPS ≥20 participants of the control arm to address the first primary hypothesis. The comparison was based on a Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG and HPV status.||1.29|0.76|0.46791
72606758|NCT02358031|144741346|SUPERIORITY||Hazard Ratio (HR)|0.83||||0.01985|TWO_SIDED|95.0|0.7|0.99||One-sided p-value based on log-rank test stratified by ECOG, HPV status and PD-L1 status.|Regression, Cox|||OS in all participants of the pembro mono arm was compared to OS in all participants of the control arm to address the tenth primary hypothesis. The comparison was based on a Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG, HPV status and PD-L1 status.||0.99|0.70|0.01985
72606759|NCT02358031|144741347|SUPERIORITY||Hazard Ratio (HR)|0.74||||0.00133|TWO_SIDED|95.0|0.61|0.9||One-sided p-value based on log-rank test stratified by ECOG, HPV status and PD-L1 status.|Regression, Cox|||OS in CPS ≥1 participants of the pembro mono arm was compared to OS in CPS ≥1 participants of the control arm to address the eighth primary hypothesis. The comparison was based on a Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG, HPV status and PD-L1 status.||0.90|0.61|0.00133
72606760|NCT02358031|144741348|SUPERIORITY||Hazard Ratio (HR)|0.58||||0.0001|TWO_SIDED|95.0|0.44|0.78||One-sided p-value based on log-rank test stratified by ECOG and HPV status.|Regression, Cox|||OS in CPS ≥20 participants of the pembro mono arm was compared to OS in CPS ≥20 participants of the control arm to address the seventh primary hypothesis. The comparison was based on a Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG and HPV status.||0.78|0.44|0.00010
72606761|NCT02358031|144741355|OTHER||Difference in ORR Percentage|-0.8||||0.574|TWO_SIDED|95.0|-8.7|7.2||No formal hypothesis testing performed; nominal p-value provided for treatment comparison.|Miettinen & Nurminen method|||ORR in all participants of the pembro combo arm was compared to ORR in all participants of the control arm. The comparison was based on Miettinen \& Nurminen method stratified by ECOG (0 vs. 1), HPV status (Positive vs. Negative) and PD-L1 TPS status (Strongly Positive, Not Strongly Positive).||7.2|-8.7|0.5740
72606762|NCT02358031|144741356|OTHER||Difference in ORR Percentage|0.5||||0.4586|TWO_SIDED|95.0|-8.2|9.1||No formal hypothesis testing performed; nominal p-value provided for treatment comparison.|Miettinen & Nurminen method|||ORR in CPS ≥1 participants of the pembro combo arm was compared to ORR in CPS ≥1 participants of the control arm. The comparison was based on Miettinen \& Nurminen method stratified by ECOG (0 vs. 1), HPV status (Positive vs. Negative) and PD-L1 TPS status (Strongly Positive, Not Strongly Positive).||9.1|-8.2|0.4586
72606763|NCT02358031|144741357|OTHER||Difference in ORR Percentage|5.0||||0.2161|TWO_SIDED|95.0|-7.5|17.4||No formal hypothesis testing performed; nominal p-value provided for treatment comparison.|Miettinen & Nurminen method|||ORR in CPS ≥20 participants of the pembro combo arm was compared to ORR in CPS ≥20 participants of the control arm. The comparison was based on Miettinen \& Nurminen method stratified by ECOG (0 vs. 1) and HPV status (Positive vs. Negative).||17.4|-7.5|0.2161
72606764|NCT02358031|144741358|OTHER||Difference in LS Means|0.4||||0.839|TWO_SIDED|95.0|-3.46|4.26||No formal hypothesis testing performed; nominal p-value provided for treatment comparison.|constrained Longitudinal Data Analysis|||Change from baseline to Week 15 in EORTC-QLQ-C30 GHS/QoL combined score was compared between all participants of the pembro combo arm and the control arm. Comparison based on constrained longitudinal data analysis (cLDA) model with GHS/QoL score as response variable and treatment by visit interaction, stratification factors (ECOG \[0 vs. 1\], HPV status \[Positive vs. Negative\] and PD-L1 TPS status \[Strongly Positive, Not Strongly Positive\]) as covariates.||4.26|-3.46|0.839
72606765|NCT02358031|144741359|OTHER||Hazard Ratio (HR)|1.37||||0.9497|TWO_SIDED|95.0|0.94|2.0||No formal hypothesis testing performed; nominal p-value provided for treatment comparison.|Regression, Cox|||TTD in GHS/QoL combined score was compared between all participants of the pembro combo arm and the control arm. Comparison based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG (0 vs. 1), HPV status (Positive vs. Negative) and PD-L1 TPS status (Strongly Positive, Not Strongly Positive).||2.00|0.94|0.9497
72606766|NCT02358031|144741360|OTHER||Hazard Ratio (HR)|1.37||||0.9476|TWO_SIDED|95.0|0.93|2.02||No formal hypothesis testing performed; nominal p-value provided for treatment comparison.|Regression, Cox|||TTD in EORTC QLQ-H\&N35 Pain Score was compared between all participants of the pembro combo arm and the control arm. Comparison based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG (0 vs. 1), HPV status (Positive vs. Negative) and PD-L1 TPS status (Strongly Positive, Not Strongly Positive).||2.02|0.93|0.9476
72606767|NCT02358031|144741361|OTHER||Hazard Ratio (HR)|1.05||||0.5836|TWO_SIDED|95.0|0.69|1.59||No formal hypothesis testing performed; nominal p-value provided for treatment comparison.|Regression, Cox|||TTD in EORTC QLQ-H\&N35 Swallowing Score was compared between all participants of the pembro combo arm and the control arm. Comparison based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG (0 vs. 1), HPV status (Positive vs. Negative) and PD-L1 TPS status (Strongly Positive, Not Strongly Positive).||1.59|0.69|0.5836
72606768|NCT02358031|144741368|OTHER||Difference in ORR Percentage|-19.0||||1|TWO_SIDED|95.0|-25.8|-12.1||No formal hypothesis testing performed; nominal p-value provided for treatment comparison.|Miettinen & Nurminen method|||ORR in all participants of the pembro mono arm was compared to ORR in all participants of the control arm. The comparison was based on Miettinen \& Nurminen method stratified by ECOG (0 vs. 1), HPV status (Positive vs. Negative) and PD-L1 TPS status (Strongly Positive , Not Strongly Positive).||-12.1|-25.8|1.0000
72606769|NCT02358031|144741369|OTHER||Difference in ORR Percentage|-15.9||||1|TWO_SIDED|95.0|-23.4|-8.3||No formal hypothesis testing performed; nominal p-value provided for treatment comparison.|Miettinen & Nurminen method|||ORR in CPS ≥1 participants of the pembro mono arm was compared to ORR in CPS ≥1 participants of the control arm. The comparison was based on Miettinen \& Nurminen method stratified by ECOG (0 vs. 1), HPV status (Positive vs. Negative) and PD-L1 TPS status (Strongly Positive, Not Strongly Positive).||-8.3|-23.4|1.0000
72606770|NCT02358031|144741370|OTHER||Difference in ORR Percentage|-12.8||||0.9869|TWO_SIDED|95.0|-23.8|-1.5||No formal hypothesis testing performed; nominal p-value provided for treatment comparison.|Miettinen & Nurminen method|||ORR in CPS ≥20 participants of the pembro mono arm was compared to ORR in CPS ≥20 participants of the control arm. The comparison was based on Miettinen \& Nurminen method stratified by ECOG (0 vs. 1) and HPV status (Positive vs. Negative).||-1.5|-23.8|0.9869
72606771|NCT02358031|144741371|OTHER||Difference in LS Means|0.24||||0.893|TWO_SIDED|95.0|-3.34|3.82||No formal hypothesis testing performed; nominal p-value provided for treatment comparison.|constrained Longitudinal Data Analysis|||Change from baseline to Week 15 in EORTC-QLQ-C30 GHS/QoL combined score was compared between all participants of the pembro mono arm and the control arm. Comparison based on cLDA model with GHS/QoL score as response variable and treatment by visit interaction, stratification factors (ECOG \[0 vs. 1\], HPV status \[Positive vs. Negative\] and PD-L1 TPS status \[Strongly Positive, Not Strongly Positive\]) as covariates.||3.82|-3.34|0.893
72606772|NCT02358031|144741372|OTHER||Hazard Ratio (HR)|1.38||||0.953|TWO_SIDED|95.0|0.95|2.0||No formal hypothesis testing performed; nominal p-value provided for treatment comparison.|Regression, Cox|||TTD in GHS/QoL combined score was compared between all participants of the pembro mono arm and the control arm. Comparison based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG (0 vs. 1), HPV status (Positive vs. Negative) and PD-L1 TPS status (Strongly Positive, Not Strongly Positive).||2.00|0.95|0.9530
72606773|NCT02358031|144741373|OTHER||Hazard Ratio (HR)|0.8||||0.1501|TWO_SIDED|95.0|0.53|1.21||No formal hypothesis testing performed; nominal p-value provided for treatment comparison.|Regression, Cox|||TTD in EORTC QLQ-H\&N35 Pain Score was compared between all participants of the pembro mono arm and the control arm. Comparison based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG (0 vs. 1), HPV status (Positive vs. Negative) and PD-L1 TPS status (Strongly Positive, Not Strongly Positive).||1.21|0.53|0.1501
72606774|NCT02358031|144741374|OTHER||Hazard Ratio (HR)|1.26||||0.8751|TWO_SIDED|95.0|0.85|1.88||No formal hypothesis testing performed; nominal p-value provided for treatment comparison.|Regression, Cox|||TTD in EORTC QLQ-H\&N35 Swallowing Score was compared between all participants of the pembro mono arm and the control arm. Comparison based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG (0 vs. 1), HPV status (Positive vs. Negative) and PD-L1 TPS status (Strongly Positive, Not Strongly Positive).||1.88|0.85|0.8751
72606775|NCT03101150|144741381|OTHER|A sample size of minimum 152 was calculated to be able to determine incidence of preeclampsia that is in the range of 8-17% with 80% power assuming an alpha of 5%.|Risk Ratio (RR)|0.163|||<|0.05|TWO_SIDED|95.0|0.02|1.32|||Chi-squared|||Eligible and consented study subjects were randomized according to permuted block design scheme to be allocated in 400 IU arm and 4000 IU arm.||1.32|0.02|<0.05
72606776|NCT03101150|144741382|OTHER||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
72606777|NCT03101150|144741383|OTHER||Risk Ratio (RR)|0.43|||<|0.02|TWO_SIDED|95.0|0.19|0.94|||Chi-squared|||||0.94|0.19|<0.02
72606778|NCT03163446|144741385|OTHER|Statistics considered descriptive as study designed to provide proof of concept and initial assessment of efficacy; not considered confirmatory.|Risk Difference (RD)|10.4||||0.3137|TWO_SIDED|90.0|-6.35|27.19|||Fisher Exact|||||27.19|-6.35|0.3137
72606779|NCT03163446|144741395|OTHER|P-value was ad hoc. Statistics considered descriptive as study designed to provide proof of concept and initial assessment of efficacy; not considered confirmatory.|Risk Difference (RD)|42.8||||0.0101|TWO_SIDED|90.0|14.3|71.4|||Fisher Exact|||||71.4|14.3|0.0101
72606780|NCT03163446|144741396|OTHER|P value was ad hoc. Descriptive statistics were performed.||||||0.0646|||||||Fisher Exact||||Descriptive statistics were performed.|||0.0646
72606781|NCT03163446|144741398|OTHER|P-value was ad hoc. Statistics considered descriptive as study designed to provide proof of concept and initial assessment of efficacy; not considered confirmatory.|Risk Difference (RD)|-21.3||||0.0556|TWO_SIDED|90.0|-45.1|2.5|||Fisher Exact|||||2.5|-45.1|0.0556
72606782|NCT01228591|144741422|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is assessed with a margin of -0.05logMAR.|Mean Difference (Final Values)|0.007|STANDARD_ERROR_OF_MEAN|0.0059|||TWO_SIDED|95.0|-0.0044|0.0187|||Mixed Models Analysis||The mean difference is defined by: Test lens (Acuvue Advance Plus) - control lens (Acuvue Advance)|"For Low Luminance/ High Contrast grouping (Monocular):~Ho: The test lens (Acuvue Advance Plus) will be non-inferior to the control lens (Acuvue Advance).~Ha: The test lens (Acuvue Advance Plus) will be \<= to the control lens (Acuvue Advance)."||0.0187|-0.0044|
72606783|NCT01228591|144741422|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is assessed with a margin of -0.05 logMAR.|Mean Difference (Final Values)|0.003|STANDARD_ERROR_OF_MEAN|0.0059|||TWO_SIDED|95.0|-0.0086|0.0146|||Mixed Models Analysis||The mean difference is defined by: Test lens (Acuvue Advance Plus) - control lens (Acuvue Advance)|"High Luminance/ Low Contrast grouping (Binocular):~Ho: The test lens (Acuvue Advance Plus) will be non-inferior to the control lens (Acuvue Advance).~Ha: The test lens (Acuvue Advance Plus) will be \<= to the control lens (Acuvue Advance)."||0.0146|-0.0086|
72606784|NCT01228591|144741423|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is assessed with a margin of -0.05 logMAR.|Mean Difference (Final Values)|0.016|STANDARD_ERROR_OF_MEAN|0.0061|||TWO_SIDED|95.0|0.0041|0.0282|||Mixed Models Analysis||Mean difference represents: Test lens (Advance Plus) - Control lens (Advance).|"For Low Luminance/ High Contrast Grouping (Monocular):~Ho: The test lens (Advance Plus) will be non-inferior to the control lens (Advance).~Ha: The test lens (Advance Plus) will be \<= to the control lens (Advance)."||0.0282|0.0041|
72606785|NCT01228591|144741423|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is assessed with a margin of -0.05 logMAR.|Mean Difference (Final Values)|0.021|STANDARD_ERROR_OF_MEAN|0.006|||TWO_SIDED|95.0|0.009|0.3305|||Mixed Models Analysis||Mean Difference is defined to be: test lens (Advance Plus) - control lens (Advance).|"For High Luminance/ Low Contrast Grouping (Binocular):~Ho: The test lens (Advance Plus) will be non-inferior from the control lens (Advance).~Ha: The test lens (Advance Plus) will be \<= to the control lens (Advance)."||0.3305|0.0090|
72606786|NCT01921517|144741428|SUPERIORITY|||||||0.0481|||||||t-test, 2 sided|||||||0.0481
72606787|NCT01298700|144741476|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.7||||0.148|TWO_SIDED|95.0|-11.0|1.9||P-value was stratified by baseline prostaglandin analogue (PGA) treatment(yes/no) and by baseline active ocular surface finding (present/absent).|Cochran-Mantel-Haenszel||bimatoprost 0.01% ophthalmic solution - bimatoprost 0.03% ophthalmic solution|||1.9|-11|0.148
72606788|NCT00129441|144741478|SUPERIORITY_OR_OTHER|||||||0.16||95.0|||||ANOVA|||||||0.16
72606789|NCT00129441|144741479|SUPERIORITY_OR_OTHER|||||||0.162||95.0|||||ANOVA|||||||0.162
72606790|NCT00129441|144741480|SUPERIORITY_OR_OTHER|||||||0.12||95.0|||||ANOVA|||||||0.12
72606791|NCT00129441|144741481|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANOVA|||||||0.05
72606792|NCT00129441|144741482|SUPERIORITY_OR_OTHER|||||||0.249||95.0|||||ANOVA|||||||0.249
72606793|NCT00129441|144741483|SUPERIORITY_OR_OTHER|||||||0.01|||||||ANOVA|||At week 4, mean BPRS total scores were nearly the same for the placebo group and L-830982 group as a result of a significant reduction in positive symptoms reported for the placebo group (F=9.12, df=1,13, p=0.01). For the L-830982-treated group, neither total BPRS scores nor any of the factor scores changed over the course of the trial.||||0.01
72606794|NCT00129441|144741484|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
72606795|NCT00129441|144741485|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
72606796|NCT01001429|144741486|SUPERIORITY_OR_OTHER|||||||0.04|TWO_SIDED||||||Regression, Logistic|||||||0.04
72606797|NCT01001429|144741486|SUPERIORITY_OR_OTHER|||||||0.68|TWO_SIDED||||||Regression, Linear|||UMSS scores with subjects propofol vs. Dexmetomidine group||||0.68
72606798|NCT00643760|144741500|SUPERIORITY_OR_OTHER||Adjusted mean difference versus placebo|-0.35||||0.295||95.0|-1.02|0.31||This p-value has been adjusted for multiplicity using a combination of a sequential method and the Hochberg procedure in order to maintain the overall experiment-wise alpha level of 0.05.|ANCOVA|Analysis of covariance (ANCOVA) model with body mass index (BMI), baseline 24-hour average pain intensity, and grouped center as covariates was used.||||0.31|-1.02|0.295
72606799|NCT00643760|144741500|SUPERIORITY_OR_OTHER||Adjusted mean difference versus placebo|-0.02||||0.946||95.0|-0.71|0.66||This p-value has been adjusted for multiplicity using a combination of a sequential method and the Hochberg procedure in order to maintain the overall experiment-wise alpha level of 0.05.|ANCOVA|An ANCOVA model with BMI, baseline 24-hour average pain intensity, and grouped center as covariates was used.||||0.66|-0.71|0.946
72606800|NCT00643760|144741500|SUPERIORITY_OR_OTHER||Adjusted mean difference versus placebo|-0.55||||0.105||95.0|-1.1|0.01||This p-value has been adjusted for multiplicity using a combination of a sequential method and the Hochberg procedure in order to maintain the overall experiment-wise alpha level of 0.05.|ANCOVA|An ANCOVA model with BMI, baseline 24-hour average pain intensity, and grouped center as covariates was used.||||0.01|-1.10|0.105
72606801|NCT00643760|144741500|SUPERIORITY_OR_OTHER||Adjusted mean difference versus placebo|0.43||||||95.0|-0.22|1.08||||||||1.08|-0.22|
72606802|NCT01053741|144741539|OTHER||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis is that there is no difference in epithelial surface disruption when comparing the two interventions. Power calculation was based on identifying a median difference in histology grade of 0.83, using a two-sided alpha of 0.05 with 90% power in 10 subjects.||||<0.05
72606803|NCT03143257|144741541|SUPERIORITY||Mean Difference (Net)|38.0|STANDARD_DEVIATION|16.1|<|0.0001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
72606804|NCT03143257|144741541|SUPERIORITY||Mean Difference (Net)|43.5|STANDARD_DEVIATION|20.0|<|0.0001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
72606805|NCT03143257|144741541|SUPERIORITY||Mean Difference (Net)|3.7|STANDARD_DEVIATION|5.0|<|0.0001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||< 0.0001
72606806|NCT03143257|144741544|SUPERIORITY||Overall Benefit Score|-15.0|STANDARD_DEVIATION|18.5|||TWO_SIDED||||||||The overall benefit can be determined by subtracting the aided and unaided scores of Ease of Communication, Reverberation, Background Noise \& Aversiveness. A negative score in overall benefit indicates a positive benefit to the subject.|||||
72606807|NCT00104052|144741545|SUPERIORITY_OR_OTHER||Normal approximation to the binomial|0.654||||||95.0|0.564|0.744||||||||0.744|0.564|
72606808|NCT02619617|144741557|OTHER|1.5mg SOM230 s.c. vs. Placebo s.c.|Odds Ratio (OR)|1.308||||0.698|TWO_SIDED|90.0|0.419|4.082|||Regression, Logistic|||||4.082|0.419|0.698
72606809|NCT02619617|144741558|OTHER|1.5mg SOM230 s.c. vs. Placebo s.c.|Odds Ratio (OR)|2.033||||0.385|TWO_SIDED|90.0|0.53|7.79|||Regression, Logistic|||||7.790|0.530|0.385
72606810|NCT00731822|144741644|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.6|||||TWO_SIDED|95.0|-3.9|5.1||||||||5.1|-3.9|
72606811|NCT04585919|144741648|SUPERIORITY|||||||0.005|||||||Mixed Models Analysis|Generalized linear mixed effect model controlling for secular trend, patient sociodemographic and health characteristics||||||0.005
72606812|NCT04585919|144741649|SUPERIORITY|||||||0.19|||||||Mixed Models Analysis|Generalized linear mixed effect model controlling for secular trend, patient sociodemographic and health characteristics||||||0.19
72606813|NCT01431339|144741722|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority hypothesis test is a one-sided hypothesis test performed at the 2.5% level of significance. If the lower limit of the 95% CI for the difference in response rates in the ITT population is greater than -10% the NI of dalbavancin to vancomycin/linezolid will be concluded.|Difference in Proportions|-1.5||||||95.0|-7.4|4.6|||||Confidence intervals were adjusted for fever at baseline|||4.6|-7.4|
72606814|NCT04536701|144741756|SUPERIORITY|||||||0.444|||||||t-test, 2 sided|||Total DASS score reported.||||0.444
72606815|NCT04536701|144741756|SUPERIORITY|||||||0.8378|||||||t-test, 2 sided|||Depressive Mood DASS score reported||||0.8378
72606816|NCT04536701|144741756|SUPERIORITY|||||||0.4087|||||||t-test, 2 sided|||Anxiety DASS score reported||||0.4087
72606817|NCT04536701|144741756|SUPERIORITY|||||||0.4124|||||||t-test, 2 sided|||Stress DASS score reported||||0.4124
72606818|NCT04536701|144741757|SUPERIORITY|||||||0.0508|||||||t-test, 2 sided|||Total RMBPC frequency reported||||0.0508
72606819|NCT04536701|144741757|SUPERIORITY|||||||0.026|||||||t-test, 2 sided|||Frequency of disruptive symptoms on RMBP reported||||0.026
72606820|NCT04536701|144741757|SUPERIORITY|||||||0.1861|||||||t-test, 2 sided|||Frequency of depressive symptoms on RMBPC reported||||0.1861
72606821|NCT04536701|144741757|SUPERIORITY|||||||0.9535|||||||t-test, 2 sided|||Frequency of memory symptoms on RMBPC reported||||0.9535
72606822|NCT04536701|144741757|SUPERIORITY|||||||0.0411|||||||t-test, 2 sided|||RMBPC reaction total is reported||||0.0411
72606823|NCT04536701|144741757|SUPERIORITY|||||||0.0058|||||||t-test, 2 sided|||RMBPC reaction disruptive symptoms is reported||||0.0058
72606824|NCT04536701|144741757|SUPERIORITY|||||||0.2527|||||||t-test, 2 sided|||RMBPC reaction depressive symptoms is reported||||0.2527
72606825|NCT04536701|144741757|SUPERIORITY|||||||0.3542|||||||t-test, 2 sided|||RMBPC reaction memory symptoms||||0.3542
72606826|NCT04536701|144741758|SUPERIORITY|||||||0.3857|||||||t-test, 2 sided|||||||0.3857
72606827|NCT04536701|144741759|SUPERIORITY|||||||0.7213|||||||t-test, 2 sided|||Five Facet Mindfulness Questionnaire (FFMQ) total reported||||0.7213
72606828|NCT04536701|144741759|SUPERIORITY|||||||0.6075|||||||t-test, 2 sided|||FFMQ Observing reported||||0.6075
72325009|NCT03768427|144173250|OTHER|Difference in least squares mean|Mean Difference (Final Values)|-19.5|||<|0.001|TWO_SIDED|95.0|-26.7|-12.3|||Constrained longitudinal model|||"This statistical analysis was performed by fitting a constrained longitudinal model adjusting for time and the interaction of time by treatment, and time by baseline disease risk category, including all participants with baseline data (88 participants in arm Atorvastatin 10 mg - ezetimibe 10 mg/Ator 10 mg and 89 participants in arm Atorvastatin 10mg - Atorvastatin 20 mg)."|Difference in least squares mean is Atorvastatin 10 mg - EZ 10 mg/Ator 10 mg minus Atorvastatin 10mg - Atorvastatin 20 mg.|-12.3|-26.7|<0.001
72325010|NCT03768427|144173250|OTHER|Difference in least squares mean|Mean Difference (Final Values)|-15.9|||<|0.001|TWO_SIDED|95.0|-21.0|-10.7|||Constrained longitudinal model|||"This statistical analysis was performed by fitting a constrained longitudinal model adjusting for time and the interaction of time by treatment, and time by baseline disease risk category, including all participants with baseline data (137 participants in arm Atorvastatin 20 mg - EZ 10 mg/Ator 20 mg and 140 participants in arm Atorvastatin 20 mg - Atorvastatin 40 mg)."|Atorvastatin 20 mg - EZ 10 mg/Ator 20 mg minus Atorvastatin 20 mg - Atorvastatin 40 mg.|-10.7|-21.0|<0.001
72325011|NCT02742129|144173253|SUPERIORITY|The statistical analysis compared the patient level data collected during the AIR001 period to the data collected during the placebo period. The Outcome Measure data is displaying the data as collected during each study phase and is combined together based upon expected treatment assignment for analysis.|Mean Difference (Final Values)|-0.2||||0.265|TWO_SIDED|95.0|-0.56|0.16|||Mixed Models Analysis|||The mixed models used to generate the p-values included all patients, including those with incomplete data.||0.16|-0.56|0.2650
72325012|NCT02742129|144173254|SUPERIORITY|The statistical analysis compared the patient level data collected during the AIR001 period to the data collected during the placebo period. The Outcome Measure data is displaying the data as collected during each study phase and is combined together based upon expected treatment assignment for analysis|Mean Difference (Final Values)|-14.68||||0.9069|TWO_SIDED|95.0|-263.65|234.29|||Mixed Models Analysis|||The mixed models used to generate the p-values included all patients, including those with incomplete data||234.29|-263.65|0.9069
72325013|NCT02742129|144173255|SUPERIORITY|The statistical analysis compared the patient level data collected during the AIR001 period to the data collected during the placebo period. The Outcome Measure data is displaying the data as collected during each study phase and is combined together based upon expected treatment assignment for analysis.|Mean Difference (Final Values)|0.05||||0.9338|TWO_SIDED|95.0|-1.16|1.27|||Mixed Models Analysis|||The mixed models used to generate the p-values included all patients, including those with incomplete data.||1.27|-1.16|0.9338
72325014|NCT02742129|144173256|SUPERIORITY|The statistical analysis compared the patient level data collected during the AIR001 period to the data collected during the placebo period. The Outcome Measure data is displaying the data as collected during each study phase and is combined together based upon expected treatment assignment for analysis.|Mean Difference (Final Values)|-0.29||||0.8151|TWO_SIDED|95.0|-2.79|2.2|||Mixed Models Analysis|||The mixed models used to generate the p-values included all patients, including those with incomplete data.||2.20|-2.79|0.8151
72325015|NCT02742129|144173257|SUPERIORITY|The statistical analysis compared the patient level data collected during the AIR001 period to the data collected during the placebo period. The Outcome Measure data is displaying the data as collected during each study phase and is combined together based upon expected treatment assignment for analysis.|Mean Difference (Final Values)|0.82||||0.4658|TWO_SIDED|95.0|-1.41|3.05|||Mixed Models Analysis|||The mixed models used to generate the p-values included all patients, including those with incomplete data.||3.05|-1.41|0.4658
72325016|NCT02742129|144173258|SUPERIORITY|The statistical analysis compared the patient level data collected during the AIR001 period to the data collected during the placebo period. The Outcome Measure data is displaying the data as collected during each study phase and is combined together based upon expected treatment assignment for analysis.|Mean Difference (Final Values)|1.06||||0.3902|TWO_SIDED|95.0|-1.37|3.49|||Mixed Models Analysis|||The mixed models used to generate the p-values included all patients, including those with incomplete data.||3.49|-1.37|0.3902
72606829|NCT04536701|144741759|SUPERIORITY|||||||0.4136|||||||t-test, 2 sided|||FFMQ Describing reported||||0.4136
72606830|NCT04536701|144741759|SUPERIORITY|||||||0.8378|||||||t-test, 2 sided|||FFMQ Acting with Awareness reported||||0.8378
72606831|NCT04536701|144741759|SUPERIORITY|||||||0.7193|||||||t-test, 2 sided|||FFMQ Nonjudging reported||||0.7193
72606832|NCT04536701|144741759|SUPERIORITY|||||||0.4145|||||||t-test, 2 sided|||FFMQ Nonreactivity reported||||0.4145
72325017|NCT02742129|144173259|SUPERIORITY|The statistical analysis compared the patient level data collected during the AIR001 period to the data collected during the placebo period. The Outcome Measure data is displaying the data as collected during each study phase and is combined together based upon expected treatment assignment for analysis.|Mean Difference (Final Values)|10.69||||0.7404|TWO_SIDED|95.0|-53.21|74.6|||Mixed Models Analysis|||The mixed models used to generate the p-values included all patients, including those with incomplete data.||74.6|-53.21|0.7404
72325018|NCT02742129|144173260|SUPERIORITY|The statistical analysis compared the patient level data collected during the AIR001 period to the data collected during the placebo period. The Outcome Measure data is displaying the data as collected during each study phase and is combined together based upon expected treatment assignment for analysis.|Median Difference (Final Values)|0.05||||0.4282|TWO_SIDED|95.0|-0.08|0.18|||Mixed Models Analysis|||The mixed models used to generate the p-values included all patients, including those with incomplete data.||0.18|-0.08|0.4282
72325019|NCT02742129|144173262|SUPERIORITY|The statistical analysis compared the patient level data collected during the AIR001 period to the data collected during the placebo period. The Outcome Measure data is displaying the data as collected during each study phase and is combined together based upon expected treatment assignment for analysis.|Mean Difference (Final Values)|-0.49||||0.1067|TWO_SIDED|95.0|-1.08|0.11|||Mixed Models Analysis|||The mixed models used to generate the p-values included all patients, including those with incomplete data.||0.11|-1.08|0.1067
72606833|NCT04536701|144741760|SUPERIORITY|||||||0.5368|||||||t-test, 2 sided|||||||0.5368
72606834|NCT04536701|144741761|SUPERIORITY|||||||0.2845|||||||t-test, 2 sided|||FAD Total reported||||0.2845
72606835|NCT04536701|144741761|SUPERIORITY|||||||0.1386|||||||t-test, 2 sided|||FAD Problem Solving is reported||||0.1386
72606836|NCT04536701|144741761|SUPERIORITY|||||||0.7551|||||||t-test, 2 sided|||FAD Communication is reported||||0.7551
72606837|NCT04536701|144741761|SUPERIORITY|||||||0.7213|||||||t-test, 2 sided|||FAD Roles is reported||||0.7213
72606838|NCT04536701|144741761|SUPERIORITY|||||||0.3233|||||||t-test, 2 sided|||FAD Affective Responsiveness is reported||||0.3233
72606839|NCT04536701|144741761|SUPERIORITY|||||||0.2832|||||||t-test, 2 sided|||FAD Affective Involvement is reported||||0.2832
72606840|NCT04536701|144741761|SUPERIORITY|||||||0.6831|||||||t-test, 2 sided|||FAD Behavior Control is reported||||0.6831
72606841|NCT04536701|144741761|SUPERIORITY|||||||0.6075|||||||t-test, 2 sided|||FAD General Functioning is reported||||0.6075
72606842|NCT00791219|144741764|NON_INFERIORITY|To demonstrate non-inferiority an upper bound 95% confidence interval approach comparing the difference between the cure rate in the Test and the Reference groups was used. If the lower bound 95% confidence interval of the difference between the proportion of patients in the Test group compared to the Reference group considered a Therapeutic Cure, Clinical Cure and Mycological Cure as appropriate, at Week 24 was greater than -20 then non-inferiority was considered to have been demonstrated|-20|6.47|||||ONE_SIDED|95.0|-1.77||||||||||-1.77|
72606843|NCT00791219|144741764|SUPERIORITY||||||<|0.05|||||||one-sided continuity corrected Z-test|||The ITT was used for all superiority testing. For the three primary endpoints and all four secondary endpoints, if the difference between the proportion of patients considered a cure was statistically greater (p\<0.05) than the proportion of patients considered a cure in the Placebo group, then superiority was considered to have been demonstrated. A one-sided continuity corrected Z-test was used for superiority testing||||<0.05
72606844|NCT00791219|144741765|NON_INFERIORITY|To demonstrate non-inferiority an upper bound 95% confidence interval approach comparing the difference between the cure rate in the Test and the Reference groups was used. If the lower bound 95% confidence interval of the difference between the proportion of patients in the Test group compared to the Reference group considered a Therapeutic Cure, Clinical Cure and Mycological Cure as appropriate, at Week 24 was greater than -20 then non-inferiority was considered to have been demonstrated|-20|10.38|||||ONE_SIDED|95.0|0.92|||||||To demonstrate non-inferiority an upper bound 95% confidence interval approach comparing the difference between the cure rate in the Test and the Reference groups was used. If the lower bound 95% confidence interval of the difference between the proportion of patients in the Test group compared to the Reference group considered a Therapeutic Cure, Clinical Cure and Mycological Cure as appropriate, at Week 24 was greater than -20 then non-inferiority was considered to have been demonstrated|||0.92|
72606845|NCT00791219|144741765|SUPERIORITY||||||<|0.05|||||||one-sided continuity corrected Z-test|||The ITT was used for all superiority testing. For the three primary endpoints and all four secondary endpoints, if the difference between the proportion of patients considered a cure was statistically greater (p\<0.05) than the proportion of patients considered a cure in the Placebo group, then superiority was considered to have been demonstrated. A one-sided continuity corrected Z-test was used for superiority testing||||<0.05
72606846|NCT00791219|144741766|NON_INFERIORITY|To demonstrate non-inferiority an upper bound 95% confidence interval approach comparing the difference between the cure rate in the Test and the Reference groups was used. If the lower bound 95% confidence interval of the difference between the proportion of patients in the Test group compared to the Reference group considered a Therapeutic Cure, Clinical Cure and Mycological Cure as appropriate, at Week 24 was greater than -20 then non-inferiority was considered to have been demonstrated|-20|3.17|||||ONE_SIDED|95.0|-10.62||||||||||-10.62|
72606847|NCT00791219|144741766|SUPERIORITY||||||<|0.05|||||||one-sided continuity corrected Z-test|||The ITT was used for all superiority testing. For the three primary endpoints and all four secondary endpoints, if the difference between the proportion of patients considered a cure was statistically greater (p\<0.05) than the proportion of patients considered a cure in the Placebo group, then superiority was considered to have been demonstrated. A one-sided continuity corrected Z-test was used for superiority testing||||<0.05
72606848|NCT00791219|144741769|NON_INFERIORITY|If the lower bound 95% confidence interval of the difference between the proportion of patients in the Test group compared to the Reference group considered a Therapeutic Cure, Clinical Cure or Mycological Cure as appropriate at Visit 7 was greater than -20 then non-inferiority was considered to have been demonstrated|-20|-0.57|||||ONE_SIDED|95.0|-12.91|||||||If the lower bound 95% confidence interval of the difference between the proportion of patients in the Test group compared to the Reference group considered a Therapeutic Cure, Clinical Cure or Mycological Cure as appropriate at Visit 7 was greater than -20 then non-inferiority was considered to have been demonstrated|||-12.91|
72606849|NCT00791219|144741770|SUPERIORITY||Mean Difference (Final Values)|0.0018|||<|0.05|TWO_SIDED|||||It the difference between the proportion of patients considered a cure was statistically greater (p\<0.05) than the proportion of patients considered a cure in the Placebo group, then superiority was considered to have been demonstrated.|A one-sided continuity corrected Z-test|||For the three primary endpoints and all four dichotomous secondary endpoints, if the difference between the proportion of patients considered a cure in the Test or Reference group was statistically greater (p \< 0.05) than the proportion of patients considered a cure in the Placebo group, then superiority of that treatment over placebo was considered to have been demonstrated. A one-sided continuity corrected Z-test was used for superiority testing.||||<0.05
72606850|NCT00791219|144741770|SUPERIORITY||Median Difference (Final Values)|0.0853|||<|0.05|TWO_SIDED||||||A one-sided continuity corrected Z-test|||For the three primary endpoints and all four dichotomous secondary endpoints, if the difference between the proportion of patients considered a cure in the Test or Reference group was statistically greater (p \< 0.05) than the proportion of patients considered a cure in the Placebo group, then superiority of that treatment over placebo was considered to have been demonstrated. A one-sided continuity corrected Z-test was used for superiority testing.||||<0.05
72325020|NCT02742129|144173263|SUPERIORITY|The statistical analysis compared the patient level data collected during the AIR001 period to the data collected during the placebo period. The Outcome Measure data is displaying the data as collected during each study phase and is combined together based upon expected treatment assignment for analysis.|Mean Difference (Final Values)|-0.1||||0.4411|TWO_SIDED|95.0|-0.37|0.16|||Mixed Models Analysis|||The mixed models used to generate the p-values included all patients, including those with incomplete data.||0.16|-0.37|0.4411
72606851|NCT03311945|144741791|OTHER||||||||||||||||||This was a single-arm study without a comparator group; therefore, no formal hypothesis testing was conducted. The primary endpoint-therapeutic failure at 48 weeks-was analyzed descriptively. The proportion of participants experiencing therapeutic failure was calculated for both the intention-to-treat (ITT) and on-treatment (OT) populations. Exact binomial (Clopper-Pearson) 95% confidence intervals were used to estimate the failure rates.|||
72606852|NCT01107925|144741811|NON_INFERIORITY_OR_EQUIVALENCE|Difference in median MPA in response to 20 μM ADP in LBW participants who received 5 mg prasugrel to the 75th percentile of MPA response to 20 μM ADP in HBW participants who received10 mg prasugrel at the end of Study Period 1 (Baseline through Day 12) was estimated from the observed data.|Estimate of the difference|-10.1||||0.526|TWO_SIDED|95.0|-23.4|0.2|||bootstrap (to determine 95% CI)||Estimate of the difference = \[median (low body weight) - Q3 (higher body weight)\]|||0.20|-23.40|0.526
72606853|NCT00490919|144741867|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.58|STANDARD_ERROR_OF_MEAN|0.225||0.0104|TWO_SIDED|95.0|-1.02|-0.14|||Mixed Models Analysis|Mixed effects general linear model with repeated measures.|Double-blind analysis (comparison between BTDS and placebo TDS) at week 12 of the double-blind phase.|Missing average pain over the last 24 hours scores after treatment discontinuation were imputed using BOCF for adverse event-related withdrawals and LOCF for withdrawals due to other reasons.||-0.14|-1.02|.0104
72606854|NCT00490919|144741868|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.124|STANDARD_ERROR_OF_MEAN|0.0874||0.1586|TWO_SIDED|95.0|-0.296|0.048||To address the issue of multiplicity and control the family-wise error rate, a gate-keeping strategy and a stepwise approach (Holms methodology) were used to evaluate the statistical significance of the secondary efficacy analyses.|ANCOVA||Mean comparison from weeks 2-12 of the double-blind phase.|||0.048|-0.296|.1586
72606855|NCT00490919|144741869|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.4|STANDARD_ERROR_OF_MEAN|1.605||0.0062|TWO_SIDED|95.0|-7.55|-1.25||To address the issue of multiplicity and control the family-wise error rate, a gate-keeping strategy and a stepwise approach (Holms methodology) were used to evaluate the statistical significance of the secondary efficacy analyses.|Mixed Models Analysis|Mixed effects general linear model with repeated measures.|Treatment comparison over Weeks 4, 8, and 12.|The primary comparison between groups was based on estimates and contrasts for the weeks 4, 8, and 12 mean values.||-1.25|-7.55|.0062
72606856|NCT04006145|144741916|SUPERIORITY||LS-Means Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.184||0.029|TWO_SIDED|95.0|-0.76|-0.04|||ANCOVA|||Change from baseline in serum LDL-C at Week 16 was analyzed using ANCOVA after the missing data imputation, with treatment group as a factor, baseline serum LDL-C, baseline LDL-C-by-treatment interaction values, and baseline lipid-lowering medications (Yes or No) as covariates. Missing data for serum LDL-C was imputed through multiple imputation method as described in the statistical analysis plan (SAP).||-0.04|-0.76|0.029
72606857|NCT01249417|144741954|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS means|-0.38||||0.0029|TWO_SIDED|95.0|-0.64|-0.13|||ANCOVA|||LS means for each treatment group and treatment comparisons, as well as the p-values were obtained from an ANCOVA on the change from baseline with treatment, baseline MAS score, age range at baseline, BTX status at baseline and centre as covariates.||-0.13|-0.64|0.0029
72606858|NCT01249417|144741954|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS means|-0.49||||0.0002|TWO_SIDED|95.0|-0.75|-0.23|||ANCOVA|||LS means for each treatment group and treatment comparisons, as well as the p-values were obtained from an ANCOVA on the change from baseline with treatment, baseline MAS score, age range at baseline, BTX status at baseline and centre as covariates.||-0.23|-0.75|0.0002
72606859|NCT01249417|144741955|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS means|0.82|||<|0.0001|TWO_SIDED|95.0|0.5|1.14|||ANOVA|||LS means for each treatment group and treatment comparisons, as well as the p-values were obtained from an ANOVA on the visit value with treatment, age range at baseline, BTX status at baseline and centre as covariates.||1.14|0.50|<0.0001
72606860|NCT01249417|144741955|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS means|0.77|||<|0.0001|TWO_SIDED|95.0|0.45|1.1|||ANOVA|||LS means for each treatment group and treatment comparisons, as well as the p-values were obtained from an ANOVA on the visit value with treatment, age range at baseline, BTX status at baseline and centre as covariates.||1.10|0.45|<0.0001
72325021|NCT02629861|144173271|SUPERIORITY||||||<|0.0001||||||0.05 level of significance|Wilcoxon (Mann-Whitney)|||Due to the deviation from the normal distribution assumption of the data, the primary analysis was conducted using the Wilcoxon rank-sum test as outlined in the SAP.||||<0.0001
72606861|NCT01249417|144741956|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS means|5.32||||0.0006|TWO_SIDED|95.0|2.31|8.32|||ANOVA|||LS means for each treatment group and treatment comparisons, as well as the p-values were obtained from an ANOVA on the visit value with treatment, age range at baseline, BTX status at baseline and centre as covariates.||8.32|2.31|0.0006
72606862|NCT01249417|144741956|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|4.65||||0.0031|TWO_SIDED|95.0|1.59|7.71|||ANOVA|||LS means for each treatment group and treatment comparisons, as well as the p-values were obtained from an ANOVA on the visit value with treatment, age range at baseline, BTX status at baseline and centre as covariates.||7.71|1.59|0.0031
72606863|NCT00917124|144741957|SUPERIORITY_OR_OTHER|||||||0.002|||||||Chi-squared, Corrected|||"Hypothesis: intraoperative monitoring of cerebral oxigenation with INVOS system will improve cognitive outcome of patients undergoing CABG procedure.~Sample size was determined assuming 50% incidence of cognitive impairment after cardiac surgery and possibility of decreasing that incidence to 30% using cerebral oximetry. Based on 0.8 power to detect a significant difference (p=0.05), 90 patients were required for each study group."||||0.002
72325022|NCT02629861|144173271|SUPERIORITY||||||<|0.0001||||||0.05 level of significance|Wilcoxon (Mann-Whitney)|||Due to the deviation from the normal distribution assumption of the data, the primary analysis was conducted using the Wilcoxon rank-sum test as outlined in the SAP.||||<0.0001
72325023|NCT02629861|144173273|SUPERIORITY||||||<|0.0001||||||0.05 level of significance|Cochran-Mantel-Haenszel|||Month 1 P-value based on Cochran-Mantel-Haenszel test stratified by baseline preventive medication use.||||<0.0001
72416772|NCT04124926|144344223|SUPERIORITY|Observed p-value and not a formal test per the preplanned fixed-sequence testing procedure. The superiority of the vonoprazan 20 mg group to lansoprazole group p-value was evaluated with a Farrington and Manning test with the null hypothesis difference ≤0 versus the alternative hypothesis difference \>0.|difference in percentage|6.1||||0.0348|TWO_SIDED|95.0|0.53|11.6||2-sided p-value.|Farrington and Manning test||The 2-sided 95% CI of the difference in EE healing rates between vonoprazan 20 mg and lansoprazole 30 mg was calculated via the Miettinen and Nurminen method.|||11.60|0.53|0.0348
72416773|NCT04124926|144344224|SUPERIORITY|The superiority of the vonoprazan 20 mg group to lansoprazole group p-value was evaluated with a Farrington and Manning test with the null hypothesis difference ≤0 versus the alternative hypothesis difference \>0.|difference in percentage|15.7||||0.0196|TWO_SIDED|95.0|2.5|28.44||2-sided p-value.|Farrington and Manning test||The 2-sided 95% CI of the difference in maintenance rates between each vonoprazan group and lansoprazole 15 mg group was calculated via the Miettinen and Nurminen method.|||28.44|2.50|0.0196
72416774|NCT04124926|144344224|SUPERIORITY|The superiority of the vonoprazan 10 mg group to lansoprazole group p-value was evaluated with a Farrington and Manning test with the null hypothesis difference ≤0 versus the alternative hypothesis difference \>0.|difference in percentage|13.3||||0.049|TWO_SIDED|95.0|0.02|26.14||2-sided p-value.|Farrington and Manning test||The 2-sided 95% CI of the difference in maintenance rates between each vonoprazan group and lansoprazole 15 mg group was calculated via the Miettinen and Nurminen method.|||26.14|0.02|0.0490
72416775|NCT04124926|144344225|NON_INFERIORITY|If the lower bound of the CI was greater than -15%, noninferiority would be concluded.|difference in mean percentage|2.0|||||TWO_SIDED|95.0|-2.63|6.72|||||The 2-sided 95% CI of the difference in mean percentage of 24-hour heartburn-free days between each vonoprazan group and the lansoprazole group was calculated from Welch's t-test.|||6.72|-2.63|
72416776|NCT04124926|144344225|NON_INFERIORITY|If the lower bound of the CI was greater than -15%, noninferiority would be concluded.|difference in mean percentage|2.3|||||TWO_SIDED|95.0|-2.27|6.84|||||The 2-sided 95% CI of the difference in mean percentage of 24-hour heartburn-free days between each vonoprazan group and the lansoprazole group was calculated from Welch's t-test.|||6.84|-2.27|
72416777|NCT00423176|144344226|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.44||||||95.0|-1.14|0.25|||||For days 1-29|||0.25|-1.14|
72416778|NCT00423176|144344226|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.82||||||95.0|-1.65|0.0|||||For follow-up days 30-43|||0.00|-1.65|
72416779|NCT00423176|144344227|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|8.8||||||95.0|-0.5|18.2|||||Change from baseline to endpoint|||18.2|-0.5|
72606864|NCT01421498|144741988|SUPERIORITY_OR_OTHER_LEGACY||Treatment difference|0.24||||0.0007|TWO_SIDED|95.0|0.1|0.38|||t-test, 2 sided|||||0.38|0.10|0.0007
72606865|NCT01421498|144741989|SUPERIORITY_OR_OTHER_LEGACY||Treatment difference|-0.02||||0.786|TWO_SIDED|95.0|-0.15|0.11|||t-test, 2 sided|||||0.11|-0.15|0.7860
72606866|NCT00243919|144742003|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.831||||0.481|TWO_SIDED|95.0|0.497|1.391||The trial tested the superiority of LTP delivered early or late, compared to HEP, using a two-sided significance level of 0.05. The study-wide error rate was controlled by applying the Hochberg step-up procedure to the two primary comparisons.|Regression, Logistic|||Logistic regression was used to compare the proportion of participants who improved functional level of walking between Early-LTP and HEP adjusting for pre-specified covariates (severity of impairment, clinical site, age, stroke type, side of hemiparesis and depression). Assuming that 30% of HEP participants would improve functional level of walking, we derived a sample size of 400 to detect a clinically relevant 20% effect size with 85% power, adjusting for an loss-to-follow-up rate of 15%.||1.391|0.497|0.481
72606867|NCT00243919|144742003|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.192||||0.501|TWO_SIDED|95.0|0.715|1.985|||Regression, Logistic|||Logistic regression was used to compare the proportion of participants who improved functional level of walking between Late-LTP and HEP adjusting for pre-specified covariates (severity of impairment, clinical site, age, stroke type, side of hemiparesis and depression).||1.985|0.715|0.501
72606868|NCT00243919|144742004|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01||||0.242||95.0||||We did not formally conduct statistical inference on the timing effect because the first primary null hypotheses is accepted. The p-value provided is the smallest alpha level that one would claim significant difference between early- and late-LTP.|Regression, Linear||Even though there was no formal inference of timing effect, we still provided descriptive statistics for the 6-month and 12-month changes. In addition, paired t-tests were used to compare within-group improvements.|The second primary analysis assessed the timing effect and its interaction with initial severity of gait impairment on walking speed change from baseline to 1 year after stroke.||||0.242
72416780|NCT03871595|144344228|OTHER|Relative bioavailability|Adjusted Geometric Mean Ratio T/R [%]|99.51|STANDARD_DEVIATION|6.3|||TWO_SIDED|90.0|95.36|103.83|||||The Adjusted Geometric Mean is adjusted by treatment. The standard deviation is actually the intraindividual geometric Coefficient of Variation \[%\].|Exploratory trial, no formal hypotheses were tested. Analysis of Variance (ANOVA) model on the logarithmic scale was used which included effects accounting for sources of variation: 'sequence' (fixed effect), 'subjects within sequences' (random effect), 'period' (fixed effect) and 'treatment' (fixed effect).||103.83|95.36|
72416781|NCT03871595|144344229|OTHER|Relative bioavailability|Adjusted Geometric Mean Ratio T/R [%]|70.11|STANDARD_DEVIATION|16.8|||TWO_SIDED|90.0|62.67|78.44|||||The Adjusted Geometric Mean is adjusted by treatment. The standard deviation is actually the intraindividual geometric Coefficient of Variation \[%\].|Exploratory trial, no formal hypotheses were tested. Analysis of Variance (ANOVA) model on the logarithmic scale was used which included effects accounting for sources of variation: 'sequence' (fixed effect), 'subjects within sequences' (random effect), 'period' (fixed effect) and 'treatment' (fixed effect).||78.44|62.67|
72416782|NCT03871595|144344230|OTHER|Relative bioavailability|Adjusted Geometric Mean Ratio T/R [%]|99.78|STANDARD_DEVIATION|6.3|||TWO_SIDED|90.0|95.64|104.11|||||The Adjusted Geometric Mean is adjusted by treatment. The standard deviation is actually the intraindividual geometric Coefficient of Variation \[%\].|Exploratory trial, no formal hypotheses were tested. Analysis of Variance (ANOVA) model on the logarithmic scale was used which included effects accounting for sources of variation: 'sequence' (fixed effect), 'subjects within sequences' (random effect), 'period' (fixed effect) and 'treatment' (fixed effect).||104.11|95.64|
72416783|NCT05554237|144344240|OTHER||Ratio of adjusted geometric means|83.46|||||TWO_SIDED|90.0|74.67|93.29|||||Analysis was performed using mixed effect model with treatment as a fixed effect and participant as a random effect (for CTB 800 mg + AVP 1350 mg versus CTB 800mg only)|||93.29|74.67|
72416784|NCT05554237|144344242|OTHER||Ratio of adjusted geometric means|89.7|||||TWO_SIDED|90.0|87.24|92.23|||||Analysis was performed using mixed effect model with treatment as a fixed effect and participant as a random effect (for CTB 800 mg + AVP 1350 mg versus CTB 800mg only|||92.23|87.24|
72606869|NCT00243919|144742005|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.94||||0.01|TWO_SIDED|95.0|1.18|3.21|||Regression, Logistic|Pairwise comparisons were conducted: Early-LTP versus Late-LTP, which had received only usual care in the 2- to 6-month post-stroke period.||Logistic regression was used to compare the proportion of participants who improved functional level of walking between early-LTP and Late-LTP (Usual Care) adjusting for pre-specified covariates (severity of impairment, clinical site, age, stroke type, side of hemiparesis and depression).||3.21|1.18|0.010
72606870|NCT00243919|144742005|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.04||||0.007|TWO_SIDED|95.0|1.22|3.42|||Regression, Logistic|Pairwise comparisons were conducted: HEP versus Late-LTP, which had received only usual care in the 2- to 6-month post-stroke period.||Logistic regression was used to compare the proportion of participants who improved functional level of walking between HEP and Late-LTP (Usual Care) adjusting for pre-specified covariates (severity of impairment, clinical site, age, stroke type, side of hemiparesis and depression).||3.42|1.22|0.007
72606871|NCT00243919|144742006|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.12|||<|0.0001|TWO_SIDED|95.0|0.08|0.16||Bonferroni adjustment for multiple testing was used in the pair-wise comparisons of the secondary outcomes. A difference is claimed to be statistically significant when p\<0.0014.|t-test, 2 sided|||6 month secondary analysis. Following the overall ANOVA test, pairwise comparison was conducted to assess differences in walking speed changes between early-LTP and late-LTP.||0.16|0.08|<0.0001
72606872|NCT00243919|144742006|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1|||<|0.0001|TWO_SIDED|95.0|0.05|0.14||Bonferroni adjustment for multiple testing was used in the pair-wise comparisons of the secondary outcomes. A difference is claimed to be statistically significant when p\<0.0014.|t-test, 2 sided|||6 month secondary analysis. Following the overall ANOVA test, pairwise comparison was conducted to assess differences in walking speed changes between HEP and late-LTP.||0.14|0.05|<.0001
72606873|NCT00243919|144742007|SUPERIORITY_OR_OTHER|||||||0.45||95.0||||Test differences across the three groups in change of 6 minute walking distance from baseline to 12-month post stroke.|ANOVA|||Primary 12 month analysis. Paired t-tests were used to compare within-group improvements and ANOVA to assess differences across the three groups followed with pairwise comparisons.||||0.45
72606874|NCT00243919|144742007|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA|Test differences across the three groups in change of 6 minute walking distance from baseline to 6-month post stroke.||6 month secondary analysis. Paired t-tests were used to compare within-group improvements and ANOVA to assess differences across the three groups followed with pairwise comparisons.||||<0.001
72606875|NCT00243919|144742008|SUPERIORITY_OR_OTHER|||||||0.1||95.0|||||Kruskal-Wallis|Test differences across the three groups in change of number of steps from baseline to 12-month post stroke.||12 month primary outcome. The Kruskal-Wallis procedure was used to assess differences across the three groups in number of steps taken in the community. Wilcoxon signed rank tests were used to compare within-group improvements.||||0.10
72606876|NCT00243919|144742008|SUPERIORITY_OR_OTHER|||||||0.04||95.0|||||Kruskal-Wallis|Test differences across the three groups in change of number of steps from baseline to 6-month post stroke.||6 month secondary analysis. The Kruskal-Wallis procedure was used to assess differences across the three groups in number of steps taken in the community. Wilcoxon signed rank tests were used to compare within-group improvements.||||0.04
72606877|NCT00243919|144742009|SUPERIORITY_OR_OTHER|||||||0.48||95.0|||||ANOVA|Test differences across the three groups in change of SIS Participation from baseline to 12-month post stroke.||12 month primary outcome. Paired t-tests were used to compare within-group improvements and ANOVA to assess differences across the three groups followed with pairwise comparisons.||||0.48
72416785|NCT05554237|144344245|OTHER||Ratio of adjusted geometric means|89.91|||||TWO_SIDED|90.0|87.47|92.41|||||Analysis was performed using mixed effect model with treatment as a fixed effect and participant as a random effect (for CTB 800 mg + AVP 1350 mg versus CTB 800mg only|||92.41|87.47|
72416786|NCT05554237|144344265|OTHER||Ratio of adjusted geometric mean|104.47|||||TWO_SIDED|90.0|84.94|128.5|||||Analysis was performed using mixed effect model with treatment as a fixed effect and participant as a random effect (fed vs fasted)|Cis-CTB Day 6 versus Day 7||128.50|84.94|
72416787|NCT05554237|144344265|OTHER||Ratio of adjusted geometric mean|129.54|||||TWO_SIDED|90.0|119.37|140.58|||||Analysis was performed using mixed effect model with treatment as a fixed effect and participant as a random effect (fed vs fasted)|Cis-CTB Day 6 versus Day 7||140.58|119.37|
72416788|NCT05554237|144344265|OTHER||Ratio of adjusted geometric mean|101.46|||||TWO_SIDED|90.0|88.68|116.08|||||Analysis was performed using mixed effect model with treatment as a fixed effect and participant as a random effect (fed vs fasted)|Cis-CTB Day 6 versus Day 7||116.08|88.68|
72606878|NCT00243919|144742009|SUPERIORITY_OR_OTHER|||||||0.06||95.0|||||ANOVA|Test differences across the three groups in change of SIS Participation from baseline to 6-month post stroke.||6 month secondary outcome. Paired t-tests were used to compare within-group improvements and ANOVA to assess differences across the three groups followed with pairwise comparisons.||||0.06
72606879|NCT00243919|144742010|SUPERIORITY_OR_OTHER|||||||0.07||95.0|||||ANOVA|Test differences across the three groups in change of SIS ADL/iADL from baseline to 12-month post stroke.||12 month primary outcome. Paired t-tests were used to compare within-group improvements and ANOVA to assess differences across the three groups followed with pairwise comparisons.||||0.07
72606880|NCT00243919|144742010|SUPERIORITY_OR_OTHER|||||||0.03||95.0|||||ANOVA|Test differences across the three groups in change of SIS ADL/iADL from baseline to 6-month post stroke.||6 month secondary outcome. Paired t-tests were used to compare within-group improvements and ANOVA to assess differences across the three groups followed with pairwise comparisons.||||0.03
72606881|NCT00243919|144742011|SUPERIORITY_OR_OTHER|||||||0.69||95.0|||||ANOVA|Test differences across the three groups in change of SIS Mobility from baseline to 12-month post stroke.||12 month primary outcome. Paired t-tests were used to compare within-group improvements and ANOVA to assess differences across the three groups followed with pairwise comparisons.||||0.69
72606882|NCT00243919|144742011|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANOVA|Test differences across the three groups in change of SIS Mobility from baseline to 6-month post stroke.||6 month secondary outcome. Paired t-tests were used to compare within-group improvements and ANOVA to assess differences across the three groups followed with pairwise comparisons.||||<.0001
72606883|NCT00243919|144742012|SUPERIORITY_OR_OTHER|||||||0.13||95.0|||||ANOVA|Test differences across the three groups in change of FM-LE from baseline to 12-month post stroke.||12 month primary analysis. Paired t-tests were used to compare within-group improvements and ANOVA to assess differences across the three groups followed with pairwise comparisons.||||0.13
72606884|NCT00243919|144742012|SUPERIORITY_OR_OTHER|||||||0.04||95.0|||||ANOVA|Test differences across the three groups in change of FM-LE from baseline to 6-month post stroke.||6 month secondary analysis. Paired t-tests were used to compare within-group improvements and ANOVA to assess differences across the three groups followed with pairwise comparisons.||||0.04
72606885|NCT00243919|144742013|SUPERIORITY_OR_OTHER|||||||0.06||95.0|||||ANOVA|Test differences across the three groups in change of Berg Balance Score from baseline to 12-month post stroke.||12 month primary outcome. Paired t-tests were used to compare within-group improvements and ANOVA to assess differences across the three groups followed with pairwise comparisons.||||0.06
72606886|NCT00243919|144742013|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||ANOVA|Test differences across the three groups in change of Berg Balance Score from baseline to 6-month post stroke.||6 month secondary outcome. Paired t-tests were used to compare within-group improvements and ANOVA to assess differences across the three groups followed with pairwise comparisons.||||0.001
72606887|NCT00243919|144742014|SUPERIORITY_OR_OTHER|||||||0.62||95.0|||||ANOVA|Test differences across the three groups in change of ABC score from baseline to 12-month post stroke.||12 month primary outcome. Paired t-tests were used to compare within-group improvements and ANOVA to assess differences across the three groups followed with pairwise comparisons.||||0.62
72606888|NCT00243919|144742014|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA|Test differences across the three groups in change of ABC score from baseline to 6-month post stroke.||6 month secondary outcome. Paired t-tests were used to compare within-group improvements and ANOVA to assess differences across the three groups followed with pairwise comparisons.||||<0.001
72606889|NCT02318849|144742081|SUPERIORITY||Change in percentage|0.09||||0.009|TWO_SIDED||||||Mixed Models Analysis|The anaylsis was adjusted for student characteristics.||The null hypothesis was that the of number students who report being a donor (or talking to parents about organ donation) both before and after exposure to the intervention would be equivalent. A secondary null hypothesis would be that longer expsosures to the intervention over time would not increase the number who report becoming a donor at the final assessment.||||0.009
72606890|NCT02318849|144742082|SUPERIORITY||Change in percentage|0.0|||>|0.1|TWO_SIDED|||||Calculated|Mixed Models Analysis|||||||>0.10
72606891|NCT02389959|144742115|OTHER|Linear regression model with repeated measures, controlling for patient's demographic factors, smoking status, and baseline level of ESS. The analysis is weighted by inverse probability treatment weight (IPTW).|Mean Difference (Net)|-1.11||||0.111|TWO_SIDED|95.0|-2.47|0.26|||Regression, Linear|||Analysis between groups at month 1.||0.26|-2.47|0.111
72606892|NCT02389959|144742115|OTHER|Linear regression model with repeated measures, controlling for patient's demographic factors, smoking status, and baseline level of ESS. The analysis is weighted by inverse probability treatment weight (IPTW).|Mean Difference (Net)|-1.26||||0.131|TWO_SIDED|95.0|-2.9|0.38|||Regression, Linear|||Analysis between groups at month 2.||0.38|-2.9|0.131
72606893|NCT02389959|144742115|OTHER|Linear regression model with repeated measures, controlling for patient's demographic factors, smoking status, and baseline level of ESS. The analysis is weighted by inverse probability treatment weight (IPTW).|Mean Difference (Net)|-0.85||||0.332|TWO_SIDED|95.0|-2.57|0.88|||Regression, Linear|||Analysis between groups at month 4.||0.88|-2.57|0.332
72606894|NCT02389959|144742115|OTHER|Linear regression model with repeated measures, controlling for patient's demographic factors, smoking status, and baseline level of ESS. The analysis is weighted by inverse probability treatment weight (IPTW).|Mean Difference (Net)|-0.48||||0.597|TWO_SIDED|95.0|-2.25|1.3|||Regression, Linear|||Analysis between groups at month 6.||1.3|-2.25|0.597
72606895|NCT02389959|144742116|OTHER|Linear regression model with repeated measures, controlling for patient's demographic factors, smoking status, and baseline level of PCS. The analysis is weighted by inverse probability treatment weight (IPTW).|Mean Difference (Net)|2.85||||0.191|TWO_SIDED|95.0|-1.44|7.13|||Regression, Linear|||Analysis between groups at month 1.||7.13|-1.44|0.191
72606896|NCT02389959|144742116|OTHER|Linear regression model with repeated measures, controlling for patient's demographic factors, smoking status, and baseline level of PCS. The analysis is weighted by inverse probability treatment weight (IPTW).|Mean Difference (Net)|0.29||||0.914|TWO_SIDED|95.0|-5.02|5.61|||Regression, Linear|||Analysis between groups at month 2||5.61|-5.02|0.914
72606897|NCT02389959|144742116|OTHER|Linear regression model with repeated measures, controlling for patient's demographic factors, smoking status, and baseline level of PCS. The analysis is weighted by inverse probability treatment weight (IPTW).|Mean Difference (Net)|1.55||||0.592|TWO_SIDED|95.0|-4.17|7.28|||Regression, Linear|||Analysis between groups at month 4.||7.28|-4.17|0.592
72606898|NCT02389959|144742116|OTHER|Linear regression model with repeated measures, controlling for patient's demographic factors, smoking status, and baseline level of PCS. The analysis is weighted by inverse probability treatment weight (IPTW).|Mean Difference (Net)|3.1||||0.31|TWO_SIDED|95.0|-2.92|9.12|||Regression, Linear|||Analysis between groups at month 6||9.12|-2.92|0.31
72416789|NCT05554237|144344265|OTHER||Ratio of adjusted geometric means|86.99|||||TWO_SIDED|90.0|74.48|101.59|||||Analysis was performed using mixed effect model with treatment as a fixed effect and participant as a random effect (fed vs fasted) for CTB 400 mg + AVP 1350 mg only|Trans-CTB Day 6 versus Day 7||101.59|74.48|
72606899|NCT02389959|144742117|OTHER|Linear regression model with repeated measures, controlling for patient's demographic factors, smoking status, and baseline level of MCS. The analysis is weighted by inverse probability treatment weight (IPTW).|Mean Difference (Net)|-2.63||||0.366|TWO_SIDED|95.0|-8.38|3.11|||Regression, Linear|||Analysis between groups at month 1.||3.11|-8.38|0.366
72416790|NCT05554237|144344267|OTHER||Ratio of adjusted geometric mean|102.21|||||TWO_SIDED|90.0|88.67|117.8|||||Analysis was performed using mixed effect model with treatment as a fixed effect and participant as a random effect (fed vs fasted)|Cis-CTB Day 6 versus Day 7||117.80|88.67|
72416791|NCT05554237|144344267|OTHER||Ratio of adjusted geometric mean|133.79|||||TWO_SIDED|90.0|119.84|149.36|||||Analysis was performed using mixed effect model with treatment as a fixed effect and participant as a random effect (fed vs fasted)|Cis-CTB Day 6 versus Day 7||149.36|119.84|
72606900|NCT02389959|144742117|OTHER|Linear regression model with repeated measures, controlling for patient's demographic factors, smoking status, and baseline level of MCS. The analysis is weighted by inverse probability treatment weight (IPTW).|Mean Difference (Net)|0.82||||0.816|TWO_SIDED|95.0|-6.12|7.76|||Regression, Linear|||Analysis between groups at month 2||7.76|-6.12|0.816
72606901|NCT02389959|144742117|OTHER|Linear regression model with repeated measures, controlling for patient's demographic factors, smoking status, and baseline level of MCS. The analysis is weighted by inverse probability treatment weight (IPTW).|Mean Difference (Net)|-4.3||||0.247|TWO_SIDED|95.0|-11.61|3.02|||Regression, Linear|||Analysis between groups at month 4.||3.02|-11.61|0.247
72325024|NCT02629861|144173273|SUPERIORITY||||||<|0.0001||||||0.05 level of significance|Cochran-Mantel-Haenszel|||Month 1 P-value based on Cochran-Mantel-Haenszel test stratified by baseline preventive medication use.||||<0.0001
72606902|NCT02389959|144742117|OTHER|Linear regression model with repeated measures, controlling for patient's demographic factors, smoking status, and baseline level of MCS. The analysis is weighted by inverse probability treatment weight (IPTW).|Mean Difference (Net)|-8.18||||0.035|TWO_SIDED|95.0|-15.76|-0.6|||Regression, Linear|||Analysis between groups at month 6||-0.6|-15.76|0.035
72606903|NCT02389959|144742118|OTHER|||||||0.03|||||||Wilcoxon rank sum test, 2-sided|||Analysis of intergroup difference at baseline.||||0.030
72606904|NCT02389959|144742118|OTHER|||||||0.719|||||||Wilcoxon rank sum test, 2-sided|||Analysis of intergroup difference at month 2.||||0.719
72606905|NCT02389959|144742118|OTHER|||||||0.467|||||||Wilcoxon rank sum test, 2-sided|||Analysis of intergroup difference at month 6.||||0.467
72606906|NCT02634073|144742119|SUPERIORITY_OR_OTHER||Ratio|0.855|||||TWO_SIDED|90.0|0.799|0.914|||ANCOVA||AUC (0-inf) comparison|||0.914|0.799|
72606907|NCT02634073|144742119|SUPERIORITY_OR_OTHER||Ratio|0.677|||||TWO_SIDED|90.0|0.635|0.721|||ANCOVA||AUC (0-inf) comparision|||0.721|0.635|
72606908|NCT02634073|144742119|SUPERIORITY_OR_OTHER||Ratio|0.637|||||TWO_SIDED|90.0|0.594|0.682|||ANCOVA||AUC (0-inf) comparision|||0.682|0.594|
72606909|NCT02634073|144742119|SUPERIORITY_OR_OTHER||Ratio|0.803|||||TWO_SIDED|90.0|0.747|0.864|||ANCOVA||AUC (0-24) comparision|||0.864|0.747|
72606910|NCT02634073|144742119|SUPERIORITY_OR_OTHER||Ratio|0.608|||||TWO_SIDED|90.0|0.566|0.655|||ANOVA||AUC (0-24) comparision|||0.655|0.566|
72606911|NCT02634073|144742119|SUPERIORITY_OR_OTHER||Ratio|0.557|||||TWO_SIDED|90.0|0.518|0.599|||ANCOVA||AUC (0-24) comparision|||0.599|0.518|
72325025|NCT02629861|144173273|SUPERIORITY|||||||0.0032||||||0.05 level of significance|Cochran-Mantel-Haenszel|||Month 2 P-value based on Cochran-Mantel-Haenszel test stratified by baseline preventive medication use.||||0.0032
72416792|NCT05554237|144344267|OTHER||Ratio of adjusted geometric mean|99.93|||||TWO_SIDED|90.0|90.7|110.1|||||Analysis was performed using mixed effect model with treatment as a fixed effect and participant as a random effect (fed vs fasted)|Cis-CTB Day 6 versus Day 7||110.10|90.70|
72325026|NCT02629861|144173273|SUPERIORITY|||||||0.001||||||0.05 level of significance|Cochran-Mantel-Haenszel|||Month 2 P-value based on Cochran-Mantel-Haenszel test stratified by baseline preventive medication use.||||0.0010
72416793|NCT05554237|144344267|OTHER||Ratio of adjusted geometric mean|89.17|||||TWO_SIDED|90.0|75.27|105.63|||||Analysis was performed using mixed effect model with treatment as a fixed effect and participant as a random effect (fed vs fasted) for CTB 400 mg + AVP 1350 mg only|Trans-CTB Day 6 versus Day 7||105.63|75.27|
72606912|NCT02634073|144742119|SUPERIORITY_OR_OTHER||Ratio|0.819|||||TWO_SIDED|90.0|0.766|0.876|||ANCOVA||AUC (0-t) comparision|||0.876|0.766|
72606913|NCT02634073|144742119|SUPERIORITY_OR_OTHER||Ratio|0.636|||||TWO_SIDED|90.0|0.595|0.68|||ANCOVA||AUC (0-t) comparision|||0.680|0.595|
72606914|NCT02634073|144742119|SUPERIORITY_OR_OTHER||Ratio|0.585|||||TWO_SIDED|90.0|0.548|0.626|||ANCOVA||AUC (0-t) comparision|||0.626|0.548|
72606915|NCT02634073|144742120|SUPERIORITY_OR_OTHER||Ratio|0.993|||||TWO_SIDED|90.0|0.916|1.08|||ANCOVA||C24 comparison|||1.08|0.916|
72606916|NCT02634073|144742120|SUPERIORITY_OR_OTHER||Ratio|1.12|||||TWO_SIDED|90.0|1.03|1.21|||ANCOVA||C24 comparision|||1.21|1.03|
72606917|NCT02634073|144742120|SUPERIORITY_OR_OTHER||Ratio|1.09|||||TWO_SIDED|90.0|1.0|1.18|||ANCOVA||C24 comparision|||1.18|1.000|
72606918|NCT02634073|144742120|SUPERIORITY_OR_OTHER||Ratio|1.33|||||TWO_SIDED|90.0|1.13|1.56|||ANCOVA||Ct comparision|||1.56|1.13|
72606919|NCT02634073|144742120|SUPERIORITY_OR_OTHER||Ratio|1.46|||||TWO_SIDED|90.0|1.25|1.71|||ANCOVA||Ct comparision|||1.71|1.25|
72606920|NCT02634073|144742120|SUPERIORITY_OR_OTHER||Ratio|1.39|||||TWO_SIDED|90.0|1.18|1.63|||ANCOVA||Ct comparision|||1.63|1.18|
72606921|NCT02634073|144742120|SUPERIORITY_OR_OTHER||Ratio|0.724|||||TWO_SIDED|90.0|0.657|0.798|||ANCOVA||Cmax comparision|||0.798|0.657|
72606922|NCT02634073|144742120|SUPERIORITY_OR_OTHER||Ratio|0.479|||||TWO_SIDED|90.0|0.434|0.527|||ANCOVA||Cmax comparision|||0.527|0.434|
72606923|NCT02634073|144742120|SUPERIORITY_OR_OTHER||Ratio|0.454|||||TWO_SIDED|90.0|0.412|0.5|||ANCOVA||Cmax comparision|||0.500|0.412|
72606924|NCT02634073|144742121|SUPERIORITY_OR_OTHER||Ratio|1.37|||||TWO_SIDED|90.0|1.11|1.69|||ANCOVA|||||1.69|1.11|
72606925|NCT02634073|144742121|SUPERIORITY_OR_OTHER||Ratio|1.53|||||TWO_SIDED|90.0|1.25|1.88|||ANCOVA|||||1.88|1.25|
72606926|NCT02634073|144742121|SUPERIORITY_OR_OTHER||Ratio|1.29|||||TWO_SIDED|90.0|1.04|1.61|||ANCOVA|||||1.61|1.04|
72606927|NCT02634073|144742122|SUPERIORITY_OR_OTHER||Ratio|1.17|||||TWO_SIDED|90.0|1.094|1.251|||ANCOVA|||||1.251|1.094|
72606928|NCT02634073|144742122|SUPERIORITY_OR_OTHER||Ratio|1.478|||||TWO_SIDED|90.0|1.386|1.576|||ANCOVA|||||1.576|1.386|
72606929|NCT02634073|144742122|SUPERIORITY_OR_OTHER||Ratio|1.571|||||TWO_SIDED|90.0|1.466|1.684|||ANCOVA|||||1.684|1.466|
72606930|NCT02256696|144742139|SUPERIORITY||Hazard Ratio (HR)|1.41||||0.1|TWO_SIDED|95.0|0.93|2.12|||Regression, Cox|adjusted for age and sex at birth.||modified intention to treat (mITT) analysis||2.12|0.93|0.10
72606931|NCT02256696|144742139|SUPERIORITY||Hazard Ratio (HR)|1.89||||0.003|TWO_SIDED|95.0|1.24|2.87|||Regression, Cox|adjusted for age and sex at birth.||mITT analysis||2.87|1.24|0.003
72606932|NCT02256696|144742139|SUPERIORITY||Hazard Ratio (HR)|1.43||||0.09|TWO_SIDED|95.0|0.95|2.15|||Regression, Cox|adjusted for age and sex at birth||per protocol||2.15|0.95|0.09
72606933|NCT02256696|144742139|SUPERIORITY||Hazard Ratio (HR)|1.87||||0.005|TWO_SIDED|95.0|1.21|2.89|||Regression, Cox|adjusted for age and sex at birth||per protocol||2.89|1.21|0.005
72606934|NCT02256696|144742142|SUPERIORITY||Hazard Ratio (HR)|1.61||||0.02|TWO_SIDED|95.0|1.07|2.44|||Regression, Cox|adjusted for age and sex at birth.||mITT analysis||2.44|1.07|0.02
72606935|NCT02256696|144742142|SUPERIORITY||Hazard Ratio (HR)|1.8||||0.006|TWO_SIDED|95.0|1.18|2.75|||Regression, Cox|adjusted for age and sex at birth||mITT analysis||2.75|1.18|0.006
72606936|NCT02256696|144742142|SUPERIORITY||Hazard Ratio (HR)|1.6||||0.03|TWO_SIDED|95.0|1.05|2.42|||Regression, Cox|adjusted for age and sex at birth||per protocol analysis||2.42|1.05|0.03
72606937|NCT02256696|144742142|SUPERIORITY||Hazard Ratio (HR)|1.84||||0.007|TWO_SIDED|95.0|1.18|2.85|||Regression, Cox|adjusted for age and sex at birth||per protocol analysis||2.85|1.18|0.007
72606938|NCT02849587|144742169|SUPERIORITY||||||<|0.001|||||||Generalized least squares model|||||||<0.001
72606939|NCT02849587|144742170|SUPERIORITY|||||||0.022|||||||Generalized least squares model|Raw data converted to z-score based on pre-smoking performance of entire sample.||||||0.022
72606940|NCT02849587|144742171|SUPERIORITY|||||||0.283|||||||Generalized least squares model|||||||0.283
72606941|NCT02849587|144742172|SUPERIORITY|||||||0.0503|||||||Generalized estimating equations model|||||||0.0503
72606942|NCT02849587|144742173|SUPERIORITY|||||||0.024|||||||Generalized least squares model|||||||0.024
72606943|NCT02849587|144742174|SUPERIORITY|||||||0.716|||||||Generalized least squares model|The outcome was standardized prior to analyses.||||||0.716
72606944|NCT02849587|144742175|SUPERIORITY|||||||0.005|||||||Generalized least squares model|The outcome was standardized prior to analysis.||||||0.005
72606945|NCT02849587|144742176|SUPERIORITY|||||||0.366|||||||Generalized Estimating Equations model|||||||.366
72606946|NCT02849587|144742177|SUPERIORITY|||||||0.225|||||||Generalized least squares model|Outcome was log10 transformed prior to analyses.||||||.225
72606947|NCT02849587|144742178|SUPERIORITY|||||||0.592|||||||Generalized least squares model|The outcome was transformed using logit function prior to analyses. Model included treatment (3 groups), time (5 times), and their interaction.||||||.592
72606948|NCT02849587|144742179|SUPERIORITY|||||||0.294|||||||Generalized least squares model|||||||.294
72606949|NCT02849587|144742180|SUPERIORITY|||||||0.144|||||||Generalized least squares model|||||||.144
72606950|NCT02849587|144742181|OTHER|Spearman's correlation||||||0.09|||||||Spearman's correlation|||||||0.090
72606951|NCT02849587|144742181|OTHER|Spearman's correlation||||||0.0006|||||||Spearman's correlation|||||||.0006
72606952|NCT02849587|144742181|OTHER|Spearman's correlation||||||0.053|||||||Spearman's correlation|||||||0.053
72606953|NCT02849587|144742182|OTHER|Spearman's correlation||||||0.3|||||||Spearman's correlation|||||||0.300
72606954|NCT02849587|144742182|OTHER|Spearman's correlation||||||0.038|||||||Spearman's correlation|||||||0.038
72606955|NCT02849587|144742182|OTHER|Spearman's correlation||||||0.175|||||||Spearman's correlation|||||||0.175
72606956|NCT00549549|144742205|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-0.46|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|-0.74|-0.18|||ANCOVA|||This was the primary analysis. The analysis was conducted using analysis of covariance (ANCOVA) with randomization stratum (2 levels: monoarticular or oligoarticular) and treatment group and region as factors, and the Patient's Assessment of Pain Intensity (for the prior 24 hours) at Baseline as a covariate.||-0.18|-0.74|
72606957|NCT00549549|144742205|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-0.24|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|-0.52|0.04|||ANCOVA|||||0.04|-0.52|
72606958|NCT00549549|144742205|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.57|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|0.29|0.84|||ANCOVA|||||0.84|0.29|
72606959|NCT00549549|144742205|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.33|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|0.05|0.6|||ANCOVA|||||0.60|0.05|
72606960|NCT00549549|144742205|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.11|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|-0.17|0.39|||ANCOVA|||||0.39|-0.17|
72606961|NCT00549549|144742206|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.08|STANDARD_ERROR_OF_MEAN|0.11|||TWO_SIDED|95.0|-0.29|0.14|||ANCOVA|||Day 5 analysis. The analysis was conducted using analysis of covariance (ANCOVA) with randomization stratum (2 levels: monoarticular or oligoarticular) and treatment group as factors, and the Patient's Assessment of Pain Intensity (for the prior 24 hours) at Baseline as a covariate.||0.14|-0.29|
72606962|NCT00549549|144742206|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.11|||TWO_SIDED|95.0|-0.42|0.02|||ANCOVA|||Day 5 analysis||0.02|-0.42|
72606963|NCT00549549|144742206|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.26|STANDARD_ERROR_OF_MEAN|0.11|||TWO_SIDED|95.0|0.04|0.47|||ANCOVA|||Day 5 analysis||0.47|0.04|
72606964|NCT00549549|144742206|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.18|STANDARD_ERROR_OF_MEAN|0.11|||TWO_SIDED|95.0|-0.04|0.39|||ANCOVA|||Day 5 analysis||0.39|-0.04|
72606965|NCT00549549|144742206|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.06|STANDARD_ERROR_OF_MEAN|0.11|||TWO_SIDED|95.0|-0.16|0.27|||ANCOVA|||Day 5 analysis||0.27|-0.16|
72606966|NCT00549549|144742206|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.11|||TWO_SIDED|95.0|-0.26|0.16|||ANCOVA|||Day 9 analysis||0.16|-0.26|
72606967|NCT00549549|144742206|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.19|STANDARD_ERROR_OF_MEAN|0.11|||TWO_SIDED|95.0|-0.4|0.03|||ANCOVA|||Day 9 analysis||0.03|-0.40|
72606968|NCT00549549|144742206|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.11|||TWO_SIDED|95.0|-0.11|0.32|||ANCOVA|||Day 9 analysis||0.32|-0.11|
72606969|NCT00549549|144742206|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.11|||TWO_SIDED|95.0|-0.16|0.27|||ANCOVA|||Day 9 analysis||0.27|-0.16|
72606970|NCT00549549|144742206|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.08|STANDARD_ERROR_OF_MEAN|0.11|||TWO_SIDED|95.0|-0.3|0.13|||ANCOVA|||Day 9 analysis||0.13|-0.30|
72606971|NCT00549549|144742206|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.12|STANDARD_ERROR_OF_MEAN|0.11|||TWO_SIDED|95.0|-0.33|0.1|||ANCOVA|||Day 14/early termination analysis||0.10|-0.33|
72606972|NCT00549549|144742206|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.32|STANDARD_ERROR_OF_MEAN|0.11|||TWO_SIDED|95.0|-0.53|-0.11|||ANCOVA|||Day 14/early termination analysis||-0.11|-0.53|
72606973|NCT00549549|144742206|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.16|STANDARD_ERROR_OF_MEAN|0.11|||TWO_SIDED|95.0|-0.05|0.37|||ANCOVA|||Day /early termination analysis||0.37|-0.05|
72606974|NCT00549549|144742206|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.04|STANDARD_ERROR_OF_MEAN|0.11|||TWO_SIDED|95.0|-0.17|0.25|||ANCOVA|||Day 14/early termination analysis||0.25|-0.17|
72325027|NCT02629861|144173273|SUPERIORITY|||||||0.0048||||||0.05 level of significance|Cochran-Mantel-Haenszel|||Month 3 P-value based on Cochran-Mantel-Haenszel test stratified by baseline preventive medication use.||||0.0048
72325028|NCT02629861|144173273|SUPERIORITY|||||||0.0003||||||0.05 level of significance|Cochran-Mantel-Haenszel|||Month 3 P-value based on Cochran-Mantel-Haenszel test stratified by baseline preventive medication use.||||0.0003
72325029|NCT02629861|144173273|SUPERIORITY||||||<|0.0001||||||0.05 level of significance|Cochran-Mantel-Haenszel|||Overall P-value based on Cochran-Mantel-Haenszel test stratified by baseline preventive medication use.||||<0.0001
72325030|NCT02629861|144173273|SUPERIORITY||||||<|0.0001||||||0.05 level of significance|Cochran-Mantel-Haenszel|||Overall P-value based on Cochran-Mantel-Haenszel test stratified by baseline preventive medication use.||||<0.0001
72325031|NCT02629861|144173274|SUPERIORITY||||||<|0.0001||||||0.05 level of significance|Wilcoxon (Mann-Whitney)|||Due to the deviation from the normal distribution assumption of the data, the Wilcoxon rank-sum test was conducted as the primary analysis for each active treatment group and placebo treatment group for this endpoint||||<0.0001
72325032|NCT02629861|144173274|SUPERIORITY||||||<|0.0001||||||0.05 level of significance|Wilcoxon (Mann-Whitney)|||Due to the deviation from the normal distribution assumption of the data, the Wilcoxon rank-sum test was conducted as the primary analysis for each active treatment group and placebo treatment group for this endpoint||||<0.0001
72325033|NCT02629861|144173275|SUPERIORITY||||||<|0.0001||||||0.05 level of significance|Wilcoxon (Mann-Whitney)|||Due to the deviation from the normal distribution assumption of the data, the Wilcoxon rank-sum test was conducted as the primary analysis for each active treatment group and placebo treatment group for this endpoint||||<0.0001
72325034|NCT02629861|144173275|SUPERIORITY||||||<|0.0001||||||0.05 level of significance|Wilcoxon (Mann-Whitney)|||Due to the deviation from the normal distribution assumption of the data, the Wilcoxon rank-sum test was conducted as the primary analysis for each active treatment group and placebo treatment group for this endpoint||||<0.0001
72606975|NCT00549549|144742206|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.16|STANDARD_ERROR_OF_MEAN|0.11|||TWO_SIDED|95.0|-0.38|0.05|||ANCOVA|||Day 14/early termination analysis||0.05|-0.38|
72606976|NCT00549549|144742207|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.04|STANDARD_ERROR_OF_MEAN|0.13|||TWO_SIDED|95.0|-0.29|0.22|||ANCOVA|||Day 5 analysis. The analysis was conducted using analysis of covariance (ANCOVA) with randomization stratum (2 levels: monoarticular or oligoarticular) and treatment group as factors, and the Patient's Assessment of Pain Intensity (for the prior 24 hours) at Baseline as a covariate.||0.22|-0.29|
72606977|NCT00549549|144742207|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.09|STANDARD_ERROR_OF_MEAN|0.13|||TWO_SIDED|95.0|-0.35|0.16|||ANCOVA|||Day 5 analysis.||0.16|-0.35|
72606978|NCT00549549|144742207|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.08|STANDARD_ERROR_OF_MEAN|0.13|||TWO_SIDED|95.0|-0.17|0.34|||ANCOVA|||Day 5 analysis.||0.34|-0.17|
72325035|NCT02629861|144173276|SUPERIORITY||||||<|0.0001||||||0.05 level of significance|Wilcoxon (Mann-Whitney)|||Due to the deviation from the normal distribution assumption of the data, the Wilcoxon rank-sum test was conducted as the primary analysis for each active treatment group and placebo treatment group for this endpoint.||||<0.0001
72325036|NCT02629861|144173276|SUPERIORITY||||||<|0.0001||||||0.05 level of significance|Wilcoxon (Mann-Whitney)|||Due to the deviation from the normal distribution assumption of the data, the Wilcoxon rank-sum test was conducted as the primary analysis for each active treatment group and placebo treatment group for this endpoint.||||<0.0001
72325037|NCT02629861|144173277|SUPERIORITY|||||||0.0023||||||0.05 level of significance|Wilcoxon (Mann-Whitney)|||Due to the deviation from the normal distribution assumption of the data, the Wilcoxon rank-sum test was conducted as the primary analysis for each active treatment group and placebo treatment group for this endpoint.||||0.0023
72325038|NCT02629861|144173277|SUPERIORITY|||||||0.0021||||||0.05 level of significance|Wilcoxon (Mann-Whitney)|||Due to the deviation from the normal distribution assumption of the data, the Wilcoxon rank-sum test was conducted as the primary analysis for each active treatment group and placebo treatment group for this endpoint.||||0.0021
72325039|NCT01685684|144173285|SUPERIORITY_OR_OTHER_LEGACY||Marginal Mean Difference (Net)|-1.56|STANDARD_ERROR_OF_MEAN|0.267|<|0.0001|TWO_SIDED||||||z-test|||||||<0.0001
72325040|NCT00902330|144173299|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||t-test, 2 sided|||Spearman correlation coefficients were computed for the biomarkers. P-Values shown are not adjusted for multiple comparisons. The a priori threshold for statistical significance was P less than 0.05. This information applies to all rows listed in the table.||||<0.05
72325041|NCT00656370|144173341|SUPERIORITY|||||||0.93|||||||Wilcoxon signed rank test|||||||0.93
72325042|NCT00656370|144173342|SUPERIORITY|||||||0.67|||||||Wilcoxon signed rank test|||||||0.67
72325043|NCT01342094|144173353|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.5|||<|0.001|TWO_SIDED|95.0|-2.2|-0.9|||ANCOVA|||||-0.9|-2.2|< 0.001
72325044|NCT01147302|144173355|SUPERIORITY_OR_OTHER_LEGACY||Mean treatment difference|8.89||||0.6498|TWO_SIDED|95.0|-24.65|42.42||The p-value for testing the mean for the treatment difference comparison assessed from ANOVA model analysis for CINRYZE versus placebo.|ANOVA|||Analysis of C4d score||42.42|-24.65|0.6498
72325045|NCT01147302|144173355|SUPERIORITY_OR_OTHER_LEGACY||Mean treatment difference|18.56||||0.0768|TWO_SIDED|95.0|1.43|35.68||The p-value for testing the mean for the treatment difference comparison assessed from ANOVA model analysis for CINRYZE versus placebo.|ANOVA|||Analysis of margination score||35.68|1.43|0.0768
72325046|NCT01147302|144173355|SUPERIORITY_OR_OTHER_LEGACY||Mean treatment difference|-4.0||||0.6928|TWO_SIDED|95.0|-21.36|13.36||The p-value for testing the mean for the treatment difference comparison assessed from ANOVA model analysis for CINRYZE versus placebo.|ANOVA|||Analysis of glomerulitis score||13.36|-21.36|0.6928
72325047|NCT01147302|144173355|SUPERIORITY_OR_OTHER_LEGACY||Mean treatment difference|7.11||||0.0508|TWO_SIDED|95.0|1.23|12.99||The p-value for testing the mean for the treatment difference comparison assessed from ANOVA model analysis for CINRYZE versus placebo.|ANOVA|||Analysis of vasculitis score||12.99|1.23|0.0508
72325048|NCT01147302|144173355|SUPERIORITY_OR_OTHER_LEGACY||Mean treatment difference|-4.89||||0.2042|TWO_SIDED|95.0|-11.34|1.56||The p-value for testing the mean for the treatment difference comparison assessed from ANOVA model analysis for CINRYZE versus placebo.|ANOVA|||Analysis of glomerulosclerosis score||1.56|-11.34|0.2042
72606979|NCT00549549|144742207|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.13|||TWO_SIDED|95.0|-0.2|0.3|||ANCOVA|||Day 5 analysis.||0.30|-0.20|
72606980|NCT00549549|144742207|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.13|||TWO_SIDED|95.0|-0.26|0.25|||ANCOVA|||Day 5 analysis.||0.25|-0.26|
72606981|NCT00549549|144742207|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.12|STANDARD_ERROR_OF_MEAN|0.12|||TWO_SIDED|95.0|-0.36|0.11|||ANCOVA|||Day 9 analysis.||0.11|-0.36|
72606982|NCT00549549|144742207|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.12|||TWO_SIDED|95.0|-0.44|0.04|||ANCOVA|||Day 9 analysis.||0.04|-0.44|
72606983|NCT00549549|144742207|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.22|STANDARD_ERROR_OF_MEAN|0.12|||TWO_SIDED|95.0|-0.01|0.46|||ANCOVA|||Day 9 analysis.||0.46|-0.01|
72606984|NCT00549549|144742207|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.12|||TWO_SIDED|95.0|-0.14|0.33|||ANCOVA|||Day 9 analysis.||0.33|-0.14|
72606985|NCT00549549|144742207|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.12|||TWO_SIDED|95.0|-0.22|0.26|||ANCOVA|||Day 9 analysis.||0.26|-0.22|
72606986|NCT00549549|144742207|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.14|STANDARD_ERROR_OF_MEAN|0.12|||TWO_SIDED|95.0|-0.38|0.1|||ANCOVA|||Day 14/early termination analysis||0.10|-0.38|
72606987|NCT00549549|144742207|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.28|STANDARD_ERROR_OF_MEAN|0.12|||TWO_SIDED|95.0|-0.52|-0.04|||ANCOVA|||Day 14/early termination analysis||-0.04|-0.52|
72606988|NCT00549549|144742207|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.16|STANDARD_ERROR_OF_MEAN|0.12|||TWO_SIDED|95.0|-0.08|0.39|||ANCOVA|||Day 14/early termination analysis||0.39|-0.08|
72606989|NCT00549549|144742207|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.12|||TWO_SIDED|95.0|-0.22|0.26|||ANCOVA|||Day 14/early termination analysis||0.26|-0.22|
72606990|NCT00549549|144742207|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.12|STANDARD_ERROR_OF_MEAN|0.12|||TWO_SIDED|95.0|-0.36|0.12|||ANCOVA|||Day 14/early termination analysis||0.12|-0.36|
72606991|NCT00549549|144742208|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6402|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Day 5 analyses. Pairwise p-values are presented, calculated using Cochran-Mantel-Haenszel statistics, stratified by number of affected joints \[1 or \>1\]) and region.||||0.6402
72606992|NCT00549549|144742208|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9739|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Day 5 analyses||||0.9739
72606993|NCT00549549|144742208|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4581|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Day 5 analyses||||0.4581
72606994|NCT00549549|144742208|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2962|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Day 5 analyses||||0.2962
72606995|NCT00549549|144742208|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4951|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Day 5 analyses||||0.4951
72606996|NCT00549549|144742208|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4957|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Day 9 analyses||||0.4957
72606997|NCT00549549|144742208|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8364|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Day 9 analyses||||0.8364
72606998|NCT00549549|144742208|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6892|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Day 9 analyses||||0.6892
72606999|NCT00549549|144742208|SUPERIORITY_OR_OTHER_LEGACY|||||||0.411|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Day 9 analyses||||0.4110
72607000|NCT00549549|144742208|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5981|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Day 9 analyses||||0.5981
72607001|NCT00549549|144742208|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9317|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Day 14/Early Termination analyses||||0.9317
72607002|NCT00549549|144742208|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0831|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Day 14/Early Termination analyses||||0.0831
72607003|NCT00549549|144742208|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5747|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Day 14/Early Termination analyses||||0.5747
72607004|NCT00549549|144742208|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6204|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Day 14/Early Termination analyses||||0.6204
72607005|NCT00549549|144742208|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2556|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Day 14/Early Termination analysis||||0.2556
72607006|NCT00549549|144742209|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1444|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Day 5 analyses. Pairwise p-values are presented, calculated using Cochran-Mantel-Haenszel statistics, stratified by number of affected joints \[1 or \>1\]) and region.||||0.1444
72607007|NCT00549549|144742209|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7532|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Day 5 analyses||||0.7532
72607008|NCT00549549|144742209|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4722|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Day 5 analyses||||0.4722
72607009|NCT00549549|144742209|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3878|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Day 5 analyses||||0.3878
72607010|NCT00549549|144742209|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6717|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Day 5 analyses||||0.6717
72607011|NCT00549549|144742209|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3098|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Day 9 analyses||||0.3098
72607012|NCT00549549|144742209|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4356|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Day 9 analyses||||0.4356
72607013|NCT00549549|144742209|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5703|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Day 9 analyses||||0.5703
72607014|NCT00549549|144742209|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4986|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Day 9 analyses||||0.4986
72607015|NCT00549549|144742209|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7855|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Day 9 analyses||||0.7855
72607016|NCT00549549|144742209|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0169|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Day 14/Early Termination analyses||||0.0169
72607017|NCT00549549|144742209|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1353|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Day 14/Early Termination analyses||||0.1353
72607018|NCT00549549|144742209|SUPERIORITY_OR_OTHER_LEGACY|||||||0.369|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Day 14/Early Termination analyses||||0.3690
72607019|NCT00549549|144742209|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0787|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Day 14/Early Termination analyses||||0.0787
72607020|NCT00549549|144742209|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5687|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Day 14/Early Termination analyses||||0.5687
72607021|NCT00549549|144742210|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.35|STANDARD_ERROR_OF_MEAN|0.13|||TWO_SIDED|95.0|-0.6|-0.1|||ANCOVA|||The analysis was conducted using analysis of covariance (ANCOVA) with randomization stratum (2 levels: monoarticular or oligoarticular), region and treatment group as factors, and the Patient's Assessment of Pain Intensity at Baseline as a covariate.||-0.10|-0.60|
72325049|NCT01147302|144173355|SUPERIORITY_OR_OTHER_LEGACY||Mean treatment difference|-0.22||||0.3322|TWO_SIDED|95.0|-0.61|0.17||The p-value for testing the mean for the treatment difference comparison assessed from ANOVA model analysis for CINRYZE versus placebo.|ANOVA|||Analysis of chronic glomerulopathy score||0.17|-0.61|0.3322
72325050|NCT01147302|144173355|SUPERIORITY_OR_OTHER_LEGACY||Mean treatment difference|5.67||||0.4723|TWO_SIDED|95.0|-7.77|9.11||The p-value for testing the mean for the treatment difference comparison assessed from ANOVA model analysis for CINRYZE versus placebo.|ANOVA|||Analysis of interstitial fibrosis score||9.11|-7.77|0.4723
72325051|NCT01147302|144173355|SUPERIORITY_OR_OTHER_LEGACY||Mean treatment difference|4.56||||0.5103|TWO_SIDED|95.0|-7.25|16.37||The p-value for testing the mean for the treatment difference comparison assessed from ANOVA model analysis for CINRYZE versus placebo.|ANOVA|||Analysis of chronic vasculitis score||16.37|-7.25|0.5103
72325052|NCT01147302|144173356|SUPERIORITY_OR_OTHER_LEGACY||Mean treatment difference|0.08||||0.7591|TWO_SIDED|95.0|-0.35|0.51||The p-value for testing the mean for the treatment difference comparison assessed from ANOVA model analysis for CINRYZE versus placebo.|ANOVA|||Analysis of Day 20||0.51|-0.35|0.7591
72325053|NCT01147302|144173356|SUPERIORITY_OR_OTHER_LEGACY||Mean treatment difference|-0.01||||0.9533|TWO_SIDED|95.0|-0.44|0.41||The p-value for testing the mean for the treatment difference comparison assessed from ANOVA model analysis for CINRYZE versus placebo.|ANOVA|||Analysis of Day 90||0.41|-0.44|0.9533
72325054|NCT01147302|144173357|SUPERIORITY_OR_OTHER_LEGACY||Mean treatment difference|1.45||||0.9046|TWO_SIDED|95.0|-19.34|22.24||The p-value for testing the mean for the treatment difference comparison assessed from ANOVA model analysis for CINRYZE versus placebo.|ANOVA|||Analysis of Day 20||22.24|-19.34|0.9046
72325055|NCT01147302|144173357|SUPERIORITY_OR_OTHER_LEGACY||Mean treatment difference|4.68||||0.5895|TWO_SIDED|95.0|-10.19|19.55||The p-value for testing the mean for the treatment difference comparison assessed from ANOVA model analysis for CINRYZE versus placebo.|ANOVA|||Analysis of Day 90||19.55|-10.19|0.5895
72325056|NCT01147302|144173358|SUPERIORITY_OR_OTHER_LEGACY||Mean treatment difference|1.56||||0.4558|TWO_SIDED|90.0|-2.0|5.11||The p-value for testing the mean for the treatment difference comparison assessed from ANOVA model analysis for CINRYZE versus placebo.|ANOVA|||Analysis of Day 1 through Day 20||5.11|-2.00|0.4558
72325057|NCT01147302|144173358|SUPERIORITY_OR_OTHER_LEGACY||Mean treatment difference|0.24||||0.947|TWO_SIDED|90.0|-6.05|6.52||The p-value for testing the mean for the treatment difference comparison assessed from ANOVA model analysis for CINRYZE versus placebo.|ANOVA|||Analysis of Day 1 through Day 90||6.52|-6.05|0.9470
72416794|NCT05554237|144344273|OTHER||Ratio of adjusted geometric mean|93.69|||||TWO_SIDED|90.0|78.37|112.02|||||Analysis was performed using mixed effect model with treatment as a fixed effect and participant as a random effect (fed vs fasted)|AVI- Day 6 versus Day 7||112.02|78.37|
72325058|NCT02121509|144173368|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratios of the geometric means (FDC/free combination) using an acceptance range of 80.00 to 125.00%.|Adjusted Geometric Means ratio|102.79|STANDARD_ERROR_OF_MEAN|1.023|<|0.0001|TWO_SIDED|90.0|98.938|106.789|||ANOVA|ANOVA on the logarithmic scale including effects for 'sequence', 'subjects within sequences', 'period', and 'treatment'|Ratio of (FDC 1500 fasted/ L+M 1500 fasted)|||106.789|98.938|<0.0001
72325059|NCT02121509|144173368|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratios of the geometric means (FDC/free combination) using an acceptance range of 80.00 to 125.00%.|Adjusted Geometric Means ratio|101.45|STANDARD_ERROR_OF_MEAN|1.026|<|0.0001|TWO_SIDED|90.0|96.99|106.121|||ANOVA|ANOVA on the logarithmic scale including effects for 'sequence', 'subjects within sequences', 'period', and 'treatment'.|Ratio of (FDC 1500 fed/ L+M 1500 fed)|||106.121|96.990|<0.0001
72325060|NCT02121509|144173369|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratios of the geometric means (FDC/free combination) using an acceptance range of 80.00 to 125.00%.|Adjusted Geometric Mean ratio|106.22|STANDARD_ERROR_OF_MEAN|1.046||0.0004|TWO_SIDED|90.0|98.449|114.614|||ANOVA|ANOVA on the logarithmic scale including effects for 'sequence', 'subjects within sequences', 'period', and 'treatment'.|Ratio of (FDC 1500 fasted/ L+M 1500 fasted)|||114.614|98.449|0.0004
72325061|NCT02121509|144173369|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratios of the geometric means (FDC/free combination) using an acceptance range of 80.00 to 125.00%.|Adjusted Geometric Mean ratio|106.71|STANDARD_ERROR_OF_MEAN|1.051||0.004|TWO_SIDED|90.0|97.614|116.658|||ANOVA|ANOVA on the logarithmic scale including effects for 'sequence', 'subjects within sequences', 'period', and 'treatment'.|Ratio of (FDC 1500 fed/ L+M 1500 fed)|||116.658|97.614|0.0040
72325062|NCT02121509|144173370|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratios of the geometric means (FDC/free combination) using an acceptance range of 80.00 to 125.00%.|Adjusted Geometric Mean ratio|102.03|STANDARD_ERROR_OF_MEAN|1.05||0.0001|TWO_SIDED|90.0|94.03|110.72|||ANOVA|ANOVA on the logarithmic scale including effects for 'sequence', 'subjects within sequences', 'period', and 'treatment'.|Ratio of (FDC 1500 fasted/ L+M 1500 fasted)|||110.72|94.03|0.0001
72325063|NCT02121509|144173370|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratios of the geometric means (FDC/free combination) using an acceptance range of 80.00 to 125.00%.|Adjusted Geometric Mean ratio|96.36|STANDARD_ERROR_OF_MEAN|1.04||0.0002|TWO_SIDED|90.0|89.96|103.22|||ANOVA|ANOVA on the logarithmic scale including effects for 'sequence', 'subjects within sequences', 'period', and 'treatment'.|Ratio of (FDC 1500 fed/ L+M 1500 fed)|||103.22|89.96|0.0002
72325064|NCT02121509|144173371|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratios of the geometric means (FDC/free combination) using an acceptance range of 80.00 to 125.00%.|Adjusted Geometric Means ratio|105.1|STANDARD_ERROR_OF_MEAN|1.057||0.0013|TWO_SIDED|90.0|95.829|115.269|||ANOVA|ANOVA on the logarithmic scale including effects for 'sequence', 'subjects within sequences', 'period', and 'treatment'.|Ratio of (FDC 1500 fasted/ L+M 1500 fasted)|||115.269|95.829|0.0013
72416795|NCT05554237|144344273|OTHER||Ratio of adjusted geometric mean|113.07|||||TWO_SIDED|90.0|88.31|144.76|||||Analysis was performed using mixed effect model with treatment as a fixed effect and participant as a random effect (fed vs fasted)|AVI-CTB Day 6 versus Day 7||144.76|88.31|
72607022|NCT00549549|144742210|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|0.13|||TWO_SIDED|95.0|-0.75|-0.25|||ANCOVA|||Day 1 analyses||-0.25|-0.75|
72325065|NCT02121509|144173371|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratios of the geometric means (FDC/free combination) using an acceptance range of 80.00 to 125.00%.|Adjusted Geometric Means ratio|113.91|STANDARD_ERROR_OF_MEAN|1.027||0.0018|TWO_SIDED|90.0|108.749|119.318|||ANOVA|ANOVA on the logarithmic scale including effects for 'sequence', 'subjects within sequences', 'period', and 'treatment'.|Ratio of (FDC 1500 fed/ L+M 1500 fed)|||119.318|108.749|0.0018
72325066|NCT02121509|144173372|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratios of the geometric means (FDC/free combination) using an acceptance range of 80.00 to 125.00%.|Adjusted Geometric Means ratio|101.45|STANDARD_ERROR_OF_MEAN|1.035|<|0.0001|TWO_SIDED|90.0|95.748|107.487|||ANOVA|ANOVA on the logarithmic scale including effects for 'sequence', 'subjects within sequences', 'period', and 'treatment'.|Ratio of (FDC 1500 fasted/ L+M 1500 fasted)|||107.487|95.748|<0.0001
72325067|NCT02121509|144173372|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratios of the geometric means (FDC/free combination) using an acceptance range of 80.00 to 125.00%.|Adjusted Geometric Means ratio|106.33|STANDARD_ERROR_OF_MEAN|1.034||0.0002|TWO_SIDED|90.0|100.268|112.763|||ANOVA|ANOVA on the logarithmic scale including effects for 'sequence', 'subjects within sequences', 'period', and 'treatment'.|Ratio of (FDC 1500 fed/ L+M 1500 fed)|||112.763|100.268|0.0002
72325068|NCT02121509|144173373|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratios of the geometric means (FDC/free combination) using an acceptance range of 80.00 to 125.00%.|Adjusted Geometric Means ratio|102.07|STANDARD_ERROR_OF_MEAN|1.05|<|0.0001|TWO_SIDED|90.0|94.2|110.59|||ANOVA|ANOVA on the logarithmic scale including effects for 'sequence', 'subjects within sequences', 'period', and 'treatment'.|Ratio of (FDC 1500 fasted/ L+M 1500 fasted)|||110.59|94.20|<0.0001
72325069|NCT02121509|144173373|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratios of the geometric means (FDC/free combination) using an acceptance range of 80.00 to 125.00%.|Adjusted Geometric Means ratio|96.79|STANDARD_ERROR_OF_MEAN|1.04||0.0001|TWO_SIDED|90.0|90.33|103.7|||ANOVA|ANOVA on the logarithmic scale including effects for 'sequence', 'subjects within sequences', 'period', and 'treatment'.|Ratio of (FDC 1500 fed/ L+M 1500 fed)|||103.70|90.33|0.0001
72325070|NCT04021290|144173408|NON_INFERIORITY|Non-inferiority was be concluded if the upper bound of the two-sided 95% confidence interval (CI) for the CMH adjusted difference in the proportion of patients with plasma HIV-1 RNA ≥ 50 c/mL between each treatment group (DTG/3TC - CAR) is less than 5%.|Adjusted Difference in Percent (ADP)|-0.8|||||TWO_SIDED|95.0|-2.4|0.8|||||ADP was based on Cochran-Mantel Haenszel stratified analysis adjusting for Baseline stratification factor:Baseline third agent (protease inhibitor \[PI\], non-nucleoside reverse transcriptase inhibitor \[NNRTI\], and integrase inhibitor \[INI\]).|||0.8|-2.4|
72325071|NCT04021290|144173409|NON_INFERIORITY|Non-inferiority will be concluded if the lower bound of a 2-sided 95% confidence interval for the difference in success rates between the two treatment arms (DTG/3TC-CAR) is greater than -12%.|Adjusted Difference in Percent|1.6|||||TWO_SIDED|95.0|-2.8|5.9|||||ADP was based on Cochran-Mantel Haenszel stratified analysis adjusting for Baseline stratification factor:Baseline third agent (PI, NNRTI, and INI).|||5.9|-2.8|
72325072|NCT04021290|144173430|OTHER||Adjusted Mean|1.4|||<|0.001|TWO_SIDED|95.0|0.7|2.2|||Mixed Model Repeated Measures||MMRM adjusted for following: Treatment, Visit, Baseline Third Agent Class, Age (continuous), Sex, Race, Baseline Value (continuous), Treatment by Visit interaction, Baseline Value by Visit interaction, with Visit as the repeated factor.|||2.2|0.7|<0.001
72416796|NCT05554237|144344273|OTHER||Ratio of adjusted geometric mean|107.06||||||90.0|92.77|123.54|||||Analysis was performed using mixed effect model with treatment as a fixed effect and participant as a random effect (fed vs fasted)|AVI- Day 6 versus Day 7||123.54|92.77|
72607023|NCT00549549|144742210|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.54|STANDARD_ERROR_OF_MEAN|0.13|||TWO_SIDED|95.0|0.29|0.78|||ANCOVA|||Day 1 analyses||0.78|0.29|
72607024|NCT00549549|144742210|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.19|STANDARD_ERROR_OF_MEAN|0.13|||TWO_SIDED|95.0|-0.06|0.44|||ANCOVA|||Day 1 analyses||0.44|-0.06|
72607025|NCT00549549|144742210|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.03|STANDARD_ERROR_OF_MEAN|0.13|||TWO_SIDED|95.0|-0.21|0.28|||ANCOVA|||Day 1 analyses||0.28|-0.21|
72607026|NCT00549549|144742210|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.24|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|-0.52|0.04|||ANCOVA|||Day 2 analyses||0.04|-0.52|
72325073|NCT04021290|144173431|OTHER||Adjusted Mean|1.4|||<|0.001|TWO_SIDED|95.0|0.7|2.2|||Mixed Model Repeated Measures||MMRM adjusted for following: Treatment, Visit, Baseline Third Agent Class, Age (continuous), Sex, Race, Baseline Value (continuous), Treatment by Visit interaction, Baseline Value by Visit interaction, with Visit as the repeated factor.|||2.2|0.7|<0.001
72325074|NCT04021290|144173432|OTHER||Adjusted Mean|-1.6||||0.021|TWO_SIDED|95.0|-2.9|-0.2|||Mixed Model Repeated Measures||MMRM adjusted for following: Treatment, Visit, Baseline Third Agent Class, Age (continuous), Sex, Race, Baseline Value (continuous), Treatment by Visit interaction, Baseline Value by Visit interaction, with Visit as the repeated factor.|||-0.2|-2.9|0.021
72325075|NCT04021290|144173433|OTHER||Adjusted Mean|-0.5||||0.398|TWO_SIDED|95.0|-1.8|0.7|||Mixed Model Repeated Measures||MMRM adjusted for following: Treatment, Visit, Baseline Third Agent Class, Age (continuous), Sex, Race, Baseline Value (continuous), Treatment by Visit interaction, Baseline Value by Visit interaction, with Visit as the repeated factor.|||0.7|-1.8|0.398
72325076|NCT00636181|144173435|SUPERIORITY|||||||0.3||||||PSG outcomes employed analysis of variance for approximately normally distributed outcomes (or outcomes that could be transformed to an approximately normal distribution), and the Kruskal-Wallis test for non-normal outcomes.|Kruskal-Wallis|Pairwise differences were determined using Tukey-Kramer test- ANOVA applied or by Mann-Whitney-Wilcoxon summed rank tests and Bonferroni adjustment.||||||0.3
72416797|NCT05554237|144344273|OTHER||Ratio of adjusted geometric mean|80.68|||||TWO_SIDED|90.0|68.32|95.27|||||Analysis was performed using mixed effect model with treatment as a fixed effect and participant as a random effect (fed vs fasted)|HPA- Day 6 versus Day 7||95.27|68.32|
72416798|NCT05554237|144344273|OTHER||Ratio of adjusted geometric mean|89.92|||||TWO_SIDED|90.0|69.7|116.02|||||Analysis was performed using mixed effect model with treatment as a fixed effect and participant as a random effect (fed vs fasted)|HPA- Day 6 versus Day 7||116.02|69.70|
72325077|NCT05076045|144173482|SUPERIORITY|||||||0.03||||||This p-value has been adjusted using the Bonferroni correction. The threshold for statistical significance was p = 0.05 (two-sided).|Mixed Models Analysis|Results of the pairwise comparisons for the SNR by Session interaction in the linear mixed model analysis.||Null hypothesis is that there was no difference in percentage of correct answers between PSAPs and Control. Data were analyzed using a linear mixed-effects (LME) model. The model included session (PSAPs, Control) and signal-to-noise ratio (SNR) as within-subject factors. Participants were included as a random factor.||||0.03
72325078|NCT05076045|144173483|SUPERIORITY|||||||0.28||||||The threshold for statistical significance was p = 0.05 (two-sided).|Mixed Models Analysis|||Null hypothesis is that there was no difference in reaction time between PSAPs and Control. Data were analyzed using a linear mixed-effects (LME) model. The model included session (PSAPs, Control) and signal-to-noise ratio as within-subject factors. Participants were included as a random factor.||||0.28
72325079|NCT05076045|144173484|SUPERIORITY|||||||0.005||||||The threshold for statistical significance was p = 0.05 (two-sided).|Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in Quick Speech In Noise score between PSAPs and Control. The performance of the QuickSIN for the two sessions (PSAPs, Control) was compared using the Wilcoxon signed rank test on paired samples.||||0.005
72325080|NCT05076045|144173485|SUPERIORITY|||||||1||||||This p-value has been adjusted using the Bonferroni correction. The threshold for statistical significance was p = 0.05 (two-sided).|Mixed Models Analysis|Result of the pairwise comparisons for the SNR by Session interaction in the linear mixed model analysis.||Null hypothesis is that there was no difference in alpha power between PSAPs and Control. Data were analyzed using a linear mixed-effects (LME) model. The model included session (PSAPs, Control) and signal-to-noise ratio (SNR) as within-subject factors. Participants were included as a random factor.||||1.00
72325081|NCT05076045|144173486|SUPERIORITY|This p-value has been adjusted using the Bonferroni correction. The threshold for statistical significance was p = 0.05 (two-sided).||||||1|||||||Mixed Models Analysis|Result of the pairwise comparisons for the SNR by Session interaction in the linear mixed model analysis.||Null hypothesis is that there was no difference in alpha power between PSAPs and Control. Data were analyzed using a linear mixed-effects (LME) model. The model included session (PSAPs, Control) and signal-to-noise ratio (SNR) as within-subject factors. Participants were included as a random factor.||||1.00
72325082|NCT05076045|144173487|SUPERIORITY|||||||0.36||||||This p-value has been adjusted using the Bonferroni correction. The threshold for statistical significance was p = 0.05 (two-sided).|Mixed Models Analysis|Result of the pairwise comparisons for the SNR by Session interaction in the linear mixed model analysis.||Null hypothesis is that there was no difference in alpha power between PSAPs and Control. Data were analyzed using a linear mixed-effects (LME) model. The model included session (PSAPs, Control) and signal-to-noise ratio (SNR) as within-subject factors. Participants were included as a random factor.||||0.36
72325083|NCT05076045|144173488|SUPERIORITY||||||<|0.001||||||The threshold for statistical significance was p = 0.05 (two-sided).|Cumulative link mixed model|||Null hypothesis is that there was no difference in listening effort between PSAPs and Control. The listening effort score was analyzed using a cumulative link mixed model. A logit link function with flexible thresholds was used. The model included Session (PSAPs, Control) and Block (1, 2, 3) as within-subject factors. Participants were included as a random factor.||||<0.001
72325084|NCT03391882|144173489|SUPERIORITY||Mean Difference (Final Values)|0.23|STANDARD_ERROR_OF_MEAN|1.722||0.8944|TWO_SIDED|95.0|-3.16|3.62|||Mixed Models Analysis|||||3.62|-3.16|0.8944
72325085|NCT03391882|144173490|SUPERIORITY||Odds Ratio (OR)|1.129||||0.7777|TWO_SIDED|95.0|0.484|2.637|||generalized linear random effects model|||||2.637|0.484|0.7777
72416799|NCT05554237|144344273|OTHER||Ratio of adjusted geometric mean|97.65|||||TWO_SIDED|90.0|84.08|113.41|||||Analysis was performed using mixed effect model with treatment as a fixed effect and participant as a random effect (fed vs fasted)|HPA- Day 6 versus Day 7||113.41|84.08|
72325086|NCT03391882|144173491|SUPERIORITY|||||||0.0002|TWO_SIDED|||||The p-value is from a 1-sample, 2-sided test of the null hypothesis that the true proportion preferring APL is 50% to evaluate if a significantly higher proportion of the subjects prefer APL-130277 or not.|binomial distribution with normal approx|||||||0.0002
72325087|NCT03391882|144173492|SUPERIORITY||Odds Ratio (OR)|1.835||||0.1769|TWO_SIDED|95.0|0.759|4.438|||generalized linear random effects model|||||4.438|0.759|0.1769
72325088|NCT03391882|144173493|SUPERIORITY||Odds Ratio (OR)|1.47||||0.3922|TWO_SIDED|95.0|0.61|3.53|||generalized linear random effects model|||||3.53|0.61|0.3922
72325089|NCT02878382|144173508|SUPERIORITY||||||<|0.001||||||significance level of 5%|Chi-squared|also, Fisher's exact test and Mann-Whtiney were used for comparing the other variables in the study||||||<0.001
72325090|NCT02878382|144173510|SUPERIORITY||||||=|0.001||||||significance level of 5%|Fisher Exact|||||||=0.001
72325091|NCT02878382|144173511|SUPERIORITY||||||=|0.048|||||||Wilcoxon (Mann-Whitney)|||Student's t-test or the Mann-Whitney test was used according to the assumption of normality of data for PpIX fluorescence intensity||||=0.048
72325092|NCT01482715|144173519|OTHER||RP2D|600.0|||||TWO_SIDED||||||||||A MTD was not established based on observation of DLTs in Cycle 1 of treatment. The 600 mg BID dose was considered to be the maximum dose with an acceptable toxicity profile that could be continuously administered to patients and was selected as the recommended Phase 2 dose (RP2D).|||
72325093|NCT01634152|144173530|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.035|STANDARD_ERROR_OF_MEAN|0.032||0.2724|TWO_SIDED|95.0|-0.028|0.099|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Stepwise testing of the null hypothesis was used to test the efficacy of Tio R5 and then Tio R2.5, each over placebo. The analysis was performed in a stepwise manner, firstly for this endpoint, then Trough FEV1. Each step was only considered confirmatory if all previous steps were successful.||0.099|-0.028|0.2724
72325094|NCT01634152|144173530|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.139|STANDARD_ERROR_OF_MEAN|0.033|<|0.0001|TWO_SIDED|95.0|0.075|0.203|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Stepwise testing of the null hypothesis was used to test the efficacy of Tio R5 and then Tio R2.5, each over placebo. The analysis was performed in a stepwise manner, firstly for this endpoint, then Trough FEV1. Each step was only considered confirmatory if all previous steps were successful.||0.203|0.075|<0.0001
72416800|NCT05554237|144344274|OTHER||Ratio of adjusted geometric mean|102.33|||||TWO_SIDED|90.0|90.37|115.87|||||Analysis was performed using mixed effect model with treatment as a fixed effect and participant as a random effect (fed vs fasted)|AVI- Day 6 versus Day 7||115.87|90.37|
72416801|NCT05554237|144344274|OTHER||Ratio of adjusted geometric mean|117.83|||||TWO_SIDED|90.0|100.61|138.0|||||Analysis was performed using mixed effect model with treatment as a fixed effect and participant as a random effect (fed vs fasted)|AVI- Day 6 versus Day 7||138.00|100.61|
72607027|NCT00549549|144742210|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.46|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|-0.74|-0.18|||ANCOVA|||Day 2 analyses||-0.18|-0.74|
72607028|NCT00549549|144742210|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.57|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|0.29|0.84|||ANCOVA|||Day 2 analyses||0.84|0.29|
72607029|NCT00549549|144742210|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.33|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|0.05|0.6|||ANCOVA|||Day 2 analyses||0.60|0.05|
72607030|NCT00549549|144742210|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.11|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|-0.17|0.39|||ANCOVA|||Day 2 analyses||0.39|-0.17|
72607031|NCT00549549|144742210|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.25|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|-0.53|0.03|||ANCOVA|||Day 3 analyses||0.03|-0.53|
72607032|NCT00549549|144742210|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.55|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|-0.83|-0.26|||ANCOVA|||Day 3 analyses||-0.26|-0.83|
72607033|NCT00549549|144742210|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.6|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|0.32|0.88|||ANCOVA|||Day 3 analyses||0.88|0.32|
72607034|NCT00549549|144742210|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.36|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|0.08|0.64|||ANCOVA|||Day 3 analyses||0.64|0.08|
72607035|NCT00549549|144742210|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.06|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|-0.22|0.34|||ANCOVA|||Day 3 analyses||0.34|-0.22|
72607036|NCT00549549|144742210|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.28|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|-0.56|0.0|||ANCOVA|||Day 4 analyses||-0.00|-0.56|
72607037|NCT00549549|144742210|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.56|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|-0.84|-0.28|||ANCOVA|||Day 4 analyses||-0.28|-0.84|
72607038|NCT00549549|144742210|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.62|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|0.35|0.9|||ANCOVA|||Day 4 analyses||0.90|0.35|
72607039|NCT00549549|144742210|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.34|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|0.07|0.62|||ANCOVA|||Day 4 analyses||0.62|0.07|
72607040|NCT00549549|144742210|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.07|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|-0.21|0.34|||ANCOVA|||Day 4 analyses||0.34|-0.21|
72607041|NCT00549549|144742210|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.35|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|-0.64|-0.07|||ANCOVA|||Day 5 analyses||-0.07|-0.64|
72607042|NCT00549549|144742210|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.66|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|-0.94|-0.38|||ANCOVA|||Day 5 analyses||-0.38|-0.94|
72607043|NCT00549549|144742210|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.65|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|0.37|0.93|||ANCOVA|||Day 5 analyses||0.93|0.37|
72607044|NCT00549549|144742210|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.29|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|0.02|0.57|||ANCOVA|||Day 5 analyses||0.57|0.02|
72607045|NCT00549549|144742210|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|-0.29|0.27|||ANCOVA|||Day 5 analyses||0.27|-0.29|
72607046|NCT00549549|144742210|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.37|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|-0.65|-0.1|||ANCOVA|||Day 6 analyses||-0.10|-0.65|
72607047|NCT00549549|144742210|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.57|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|-0.84|-0.29|||ANCOVA|||Day 6 analyses||-0.29|-0.84|
72607048|NCT00549549|144742210|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.56|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|0.29|0.83|||ANCOVA|||Day 6 analyses||0.83|0.29|
72607049|NCT00549549|144742210|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.19|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|-0.08|0.46|||ANCOVA|||Day 6 analyses||0.46|-0.08|
72607050|NCT00549549|144742210|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|-0.28|0.26|||ANCOVA|||Day 6 analyses||0.26|-0.28|
72607051|NCT00549549|144742210|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.32|STANDARD_ERROR_OF_MEAN|0.15|||TWO_SIDED|95.0|-0.61|-0.04|||ANCOVA|||Day 7 analyses||-0.04|-0.61|
72607052|NCT00549549|144742210|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.63|STANDARD_ERROR_OF_MEAN|0.15|||TWO_SIDED|95.0|-0.92|-0.34|||ANCOVA|||Day 7 analyses||-0.34|-0.92|
72607053|NCT00549549|144742210|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.49|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|0.21|0.78|||ANCOVA|||Day 7 analyses||0.78|0.21|
72607054|NCT00549549|144742210|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.17|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|-0.11|0.45|||ANCOVA|||Day 7 analyses||0.45|-0.11|
72607055|NCT00549549|144742210|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.14|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|-0.42|0.15|||ANCOVA|||Day 7 analyses||0.15|-0.42|
72607056|NCT00549549|144742210|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.29|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|-0.57|0.0|||ANCOVA|||Day 8 analyses||-0.00|-0.57|
72607057|NCT00549549|144742210|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.55|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|-0.84|-0.27|||ANCOVA|||Day 8 analyses||-0.27|-0.84|
72416802|NCT05554237|144344274|OTHER||Ratio of adjusted geometric mean|115.88|||||TWO_SIDED|90.0|104.12|128.98|||||Analysis was performed using mixed effect model with treatment as a fixed effect and participant as a random effect (fed vs fasted)|AVI- Day 6 versus Day 7||128.98|104.12|
72607058|NCT00549549|144742210|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.42|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|0.14|0.7|||ANCOVA|||Day 8 analyses||0.70|0.14|
72607059|NCT00549549|144742210|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.13|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|-0.15|0.41|||ANCOVA|||Day 8 analyses||0.41|-0.15|
72607060|NCT00549549|144742210|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.14|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|-0.42|0.14|||ANCOVA|||Day 8 analyses||0.14|-0.42|
72607061|NCT00549549|144742210|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.32|STANDARD_ERROR_OF_MEAN|0.15|||TWO_SIDED|95.0|-0.61|-0.02|||ANCOVA|||Day 9 analyses||-0.02|-0.61|
72325095|NCT01634152|144173531|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.018|STANDARD_ERROR_OF_MEAN|0.034||0.5898|TWO_SIDED|95.0|-0.048|0.085|||Mixed Models Analysis|Repeated measures restricted maximum likelihood|Difference calculated as Tio R2.5 minus placebo|Stepwise testing of the null hypothesis was used to test the efficacy of Tio R5 and then Tio R2.5, each over placebo. The analysis for this endpoint was performed in a stepwise manner after the analysis of the primary endpoint was performed. Each step was only considered confirmatory if all previous steps were successful.||0.085|-0.048|0.5898
72325096|NCT01634152|144173531|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.087|STANDARD_ERROR_OF_MEAN|0.034||0.0117|TWO_SIDED|95.0|0.019|0.154|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Stepwise testing of the null hypothesis was used to test the efficacy of Tio R5 and then Tio R2.5, each over placebo. The analysis for this endpoint was performed in a stepwise manner after the analysis of the primary endpoint was performed. Each step was only considered confirmatory if all previous steps were successful.||0.154|0.019|0.0117
72325097|NCT01634152|144173532|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.043|STANDARD_ERROR_OF_MEAN|0.036||0.2277|TWO_SIDED|95.0|-0.113|0.027|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|||0.027|-0.113|0.2277
72325098|NCT01634152|144173532|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.03|STANDARD_ERROR_OF_MEAN|0.036||0.3998|TWO_SIDED|95.0|-0.04|0.101|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|||0.101|-0.040|0.3998
72325099|NCT01634152|144173533|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.048|STANDARD_ERROR_OF_MEAN|0.037||0.203|TWO_SIDED|95.0|-0.121|0.026|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|||0.026|-0.121|0.2030
72325100|NCT01634152|144173533|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.009|STANDARD_ERROR_OF_MEAN|0.038||0.8194|TWO_SIDED|95.0|-0.066|0.083|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|||0.083|-0.066|0.8194
72325101|NCT01634152|144173534|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.031|STANDARD_ERROR_OF_MEAN|0.029||0.2907|TWO_SIDED|95.0|-0.026|0.088|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|||0.088|-0.026|0.2907
72325102|NCT01634152|144173534|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.126|STANDARD_ERROR_OF_MEAN|0.03|<|0.0001|TWO_SIDED|95.0|0.068|0.184|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|||0.184|0.068|<0.0001
72325103|NCT01634152|144173535|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.041|STANDARD_ERROR_OF_MEAN|0.032||0.2008|TWO_SIDED|95.0|-0.103|0.022|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|||0.022|-0.103|0.2008
72416803|NCT05554237|144344274|OTHER||Ratio of adjusted geometric mean|85.27|||||TWO_SIDED|90.0|70.37|103.32|||||Analysis was performed using mixed effect model with treatment as a fixed effect and participant as a random effect (fed vs fasted)|HPA- Day 6 versus Day 7||103.32|70.37|
72325104|NCT01634152|144173535|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.037|STANDARD_ERROR_OF_MEAN|0.032||0.2545|TWO_SIDED|95.0|-0.026|0.1|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|||0.100|-0.026|0.2545
72325105|NCT01634152|144173538|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.02|STANDARD_ERROR_OF_MEAN|0.078||0.798|TWO_SIDED|95.0|-0.133|0.173|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|||0.173|-0.133|0.7980
72325106|NCT01634152|144173538|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.079|STANDARD_ERROR_OF_MEAN|0.079||0.3166|TWO_SIDED|95.0|-0.233|0.076|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|||0.076|-0.233|0.3166
72325107|NCT01634152|144173540|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.017|STANDARD_ERROR_OF_MEAN|0.124||0.8916|TWO_SIDED|95.0|-0.227|0.261|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|||0.261|-0.227|0.8916
72325108|NCT01634152|144173540|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.089|STANDARD_ERROR_OF_MEAN|0.126||0.4789|TWO_SIDED|95.0|-0.336|0.158|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|||0.158|-0.336|0.4789
72325109|NCT01634152|144173541|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.015|STANDARD_ERROR_OF_MEAN|0.074||0.8361|TWO_SIDED|95.0|-0.16|0.129|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|||0.129|-0.160|0.8361
72325110|NCT01634152|144173541|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.087|STANDARD_ERROR_OF_MEAN|0.075||0.2461|TWO_SIDED|95.0|-0.233|0.06|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|||0.060|-0.233|0.2461
72325111|NCT01634152|144173542|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.035|STANDARD_ERROR_OF_MEAN|0.067||0.6029|TWO_SIDED|95.0|-0.096|0.165|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|||0.165|-0.096|0.6029
72325112|NCT01634152|144173542|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.026|STANDARD_ERROR_OF_MEAN|0.067||0.7034|TWO_SIDED|95.0|-0.158|0.107|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|||0.107|-0.158|0.7034
72325113|NCT01634152|144173543|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.776|STANDARD_ERROR_OF_MEAN|4.686||0.3083|TWO_SIDED|95.0|-4.419|13.97|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|||13.970|-4.419|0.3083
72325114|NCT01634152|144173543|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.743|STANDARD_ERROR_OF_MEAN|4.747||0.3179|TWO_SIDED|95.0|-4.571|14.057|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|||14.057|-4.571|0.3179
72325115|NCT01634152|144173544|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.567|STANDARD_ERROR_OF_MEAN|4.807||0.9061|TWO_SIDED|95.0|-8.866|10.001|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|||10.001|-8.866|0.9061
72416804|NCT05554237|144344274|OTHER||Ratio of adjusted geometric mean|97.69|||||TWO_SIDED|90.0|78.83|121.06|||||Analysis was performed using mixed effect model with treatment as a fixed effect and participant as a random effect (fed vs fasted)|HPA- Day 6 versus Day 7||121.06|78.83|
72325116|NCT01634152|144173544|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.107|STANDARD_ERROR_OF_MEAN|4.867||0.399|TWO_SIDED|95.0|-13.658|5.444|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|||5.444|-13.658|0.3990
72325117|NCT01634152|144173545|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.95|STANDARD_ERROR_OF_MEAN|1.025||0.3542|TWO_SIDED|95.0|-2.959|1.06|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|||1.060|-2.959|0.3542
72325118|NCT01634152|144173545|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.502|STANDARD_ERROR_OF_MEAN|1.042||0.6298|TWO_SIDED|95.0|-2.545|1.541|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|||1.541|-2.545|0.6298
72325119|NCT01634152|144173546|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.032|STANDARD_ERROR_OF_MEAN|0.038||0.4066|TWO_SIDED|95.0|-0.107|0.043|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|||0.043|-0.107|0.4066
72325120|NCT01634152|144173546|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.049|STANDARD_ERROR_OF_MEAN|0.039||0.2032|TWO_SIDED|95.0|-0.125|0.027|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|||0.027|-0.125|0.2032
72325121|NCT01634152|144173547|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.051|STANDARD_ERROR_OF_MEAN|0.041||0.2064|TWO_SIDED|95.0|-0.131|0.028|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|||0.028|-0.131|0.2064
72325122|NCT01634152|144173547|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.061|STANDARD_ERROR_OF_MEAN|0.041||0.141|TWO_SIDED|95.0|-0.142|0.02|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|||0.020|-0.142|0.1410
72325123|NCT01634152|144173548|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.001|STANDARD_ERROR_OF_MEAN|0.042||0.9869|TWO_SIDED|95.0|-0.083|0.082|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|||0.082|-0.083|0.9869
72607062|NCT00549549|144742210|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.53|STANDARD_ERROR_OF_MEAN|0.15|||TWO_SIDED|95.0|-0.82|-0.23|||ANCOVA|||Day 9 analyses||-0.23|-0.82|
72607063|NCT00549549|144742210|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.47|STANDARD_ERROR_OF_MEAN|0.15|||TWO_SIDED|95.0|0.18|0.76|||ANCOVA|||Day 9 analyses||0.76|0.18|
72607064|NCT00549549|144742210|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.16|STANDARD_ERROR_OF_MEAN|0.15|||TWO_SIDED|95.0|-0.13|0.44|||ANCOVA|||Day 9 analyses||0.44|-0.13|
72607065|NCT00549549|144742210|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.06|STANDARD_ERROR_OF_MEAN|0.15|||TWO_SIDED|95.0|-0.35|0.23|||ANCOVA|||Day 9 analyses||0.23|-0.35|
72325124|NCT01634152|144173548|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.007|STANDARD_ERROR_OF_MEAN|0.043||0.873|TWO_SIDED|95.0|-0.077|0.09|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|||0.090|-0.077|0.8730
72325125|NCT01634152|144173549|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.006|STANDARD_ERROR_OF_MEAN|0.049||0.9043|TWO_SIDED|95.0|-0.103|0.091|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|||0.091|-0.103|0.9043
72325126|NCT01634152|144173549|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.015|STANDARD_ERROR_OF_MEAN|0.05||0.7708|TWO_SIDED|95.0|-0.112|0.083|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|||0.083|-0.112|0.7708
72325127|NCT01634152|144173550|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.036|STANDARD_ERROR_OF_MEAN|0.052||0.4864|TWO_SIDED|95.0|-0.139|0.066|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|||0.066|-0.139|0.4864
72325128|NCT01634152|144173550|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.013|STANDARD_ERROR_OF_MEAN|0.053||0.7991|TWO_SIDED|95.0|-0.117|0.09|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|||0.090|-0.117|0.7991
72325129|NCT01634152|144173551|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.007|STANDARD_ERROR_OF_MEAN|0.05||0.8884|TWO_SIDED|95.0|-0.092|0.106|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|||0.106|-0.092|0.8884
72325130|NCT01634152|144173551|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.012|STANDARD_ERROR_OF_MEAN|0.051||0.8115|TWO_SIDED|95.0|-0.112|0.088|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|||0.088|-0.112|0.8115
72325131|NCT01634152|144173552|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.016|STANDARD_ERROR_OF_MEAN|0.051||0.7498|TWO_SIDED|95.0|-0.084|0.117|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|||0.117|-0.084|0.7498
72325132|NCT01634152|144173552|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.083|STANDARD_ERROR_OF_MEAN|0.052||0.1108|TWO_SIDED|95.0|-0.185|0.019|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|||0.019|-0.185|0.1108
72325133|NCT01634152|144173553|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.015|STANDARD_ERROR_OF_MEAN|0.059||0.8055|TWO_SIDED|95.0|-0.131|0.102|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|||0.102|-0.131|0.8055
72325134|NCT01634152|144173553|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.071|STANDARD_ERROR_OF_MEAN|0.06||0.236|TWO_SIDED|95.0|-0.189|0.047|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|||0.047|-0.189|0.2360
72325135|NCT01634152|144173554|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.017|STANDARD_ERROR_OF_MEAN|0.041||0.6748|TWO_SIDED|95.0|-0.097|0.063|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|||0.063|-0.097|0.6748
72325136|NCT01634152|144173554|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.025|STANDARD_ERROR_OF_MEAN|0.041||0.5497|TWO_SIDED|95.0|-0.056|0.105|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|||0.105|-0.056|0.5497
72607066|NCT00549549|144742210|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.29|STANDARD_ERROR_OF_MEAN|0.15|||TWO_SIDED|95.0|-0.59|0.01|||ANCOVA|||Day 10 analyses||0.01|-0.59|
72607067|NCT00549549|144742210|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.46|STANDARD_ERROR_OF_MEAN|0.15|||TWO_SIDED|95.0|-0.76|-0.16|||ANCOVA|||Day 10 analyses||-0.16|-0.76|
72325137|NCT01152437|144173562|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.122||||0.0735|TWO_SIDED|90.0|0.018|0.844||The statistical analysis is descriptive and exploratory in nature and performed only to provide a statistical framework from which to view the results and plan further studies.|Regression, Logistic|Wald Chi-square test and Confidence Interval from logistic regression stratified by number of lines of palliative chemotherapy.||Null hypothesis is that the objective response rate (ORR) in KRAS wild-type patients treated with afatinib is less than or equal to the ORR in KRAS wild-type patients treated with cetuximab. Sample size is based on a 'pick the winner' approach assuming ORR for cetuximab of 12%, undesirable ORR for afatinib of 11% and desirable ORR for afatinib of 16%. As per 'pick the winner' approach, afatinib would be considered 'the winner' if the ORR for afatinib was greater than the ORR for cetuximab.||0.844|0.018|0.0735
72607068|NCT00549549|144742210|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.4|STANDARD_ERROR_OF_MEAN|0.15|||TWO_SIDED|95.0|0.1|0.69|||ANCOVA|||Day 10 analyses||0.69|0.10|
72607069|NCT00549549|144742210|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.11|STANDARD_ERROR_OF_MEAN|0.15|||TWO_SIDED|95.0|-0.18|0.41|||ANCOVA|||Day 10 analyses||0.41|-0.18|
72607070|NCT00549549|144742210|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.07|STANDARD_ERROR_OF_MEAN|0.15|||TWO_SIDED|95.0|-0.36|0.23|||ANCOVA|||Day 10 analyses||0.23|-0.36|
72607071|NCT00549549|144742210|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.26|STANDARD_ERROR_OF_MEAN|0.15|||TWO_SIDED|95.0|-0.56|0.05|||ANCOVA|||Day 11 analyses||0.05|-0.56|
72607072|NCT00549549|144742210|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.47|STANDARD_ERROR_OF_MEAN|0.15|||TWO_SIDED|95.0|-0.77|-0.17|||ANCOVA|||Day 11 analyses||-0.17|-0.77|
72607073|NCT00549549|144742210|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.4|STANDARD_ERROR_OF_MEAN|0.15|||TWO_SIDED|95.0|0.1|0.69|||ANCOVA|||Day 11 analyses||0.69|0.10|
72607074|NCT00549549|144742210|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.14|STANDARD_ERROR_OF_MEAN|0.15|||TWO_SIDED|95.0|-0.16|0.44|||ANCOVA|||Day 11 analyses||0.44|-0.16|
72607075|NCT00549549|144742210|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.07|STANDARD_ERROR_OF_MEAN|0.15|||TWO_SIDED|95.0|-0.37|0.23|||ANCOVA|||Day 11 analyses||0.23|-0.37|
72607076|NCT00549549|144742210|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.22|STANDARD_ERROR_OF_MEAN|0.16|||TWO_SIDED|95.0|-0.53|0.09|||ANCOVA|||Day 12 analyses||0.09|-0.53|
72607077|NCT00549549|144742210|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.46|STANDARD_ERROR_OF_MEAN|0.16|||TWO_SIDED|95.0|-0.77|-0.15|||ANCOVA|||Day 12 analyses||-0.15|-0.77|
72607078|NCT00549549|144742210|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.27|STANDARD_ERROR_OF_MEAN|0.15|||TWO_SIDED|95.0|-0.04|0.57|||ANCOVA|||Day 12 analyses||0.57|-0.04|
72607079|NCT00549549|144742210|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.15|||TWO_SIDED|95.0|-0.25|0.36|||ANCOVA|||Day 12 analyses||0.36|-0.25|
72325138|NCT01152437|144173563|SUPERIORITY_OR_OTHER||Percentage of participants|12.0||||0.6394|TWO_SIDED|90.0|4.9|23.9||The statistical analysis is descriptive and exploratory in nature and performed only to provide a statistical framework from which to view the results and plan further studies.|Exact binomial test|||Null hypothesis is that the disease control rate is 10% in patients with KRAS mutation. Sample size calculation based on a 2-sided exact binomial test at 10% significance level to distinguish between the historical disease control rate of 10% and a desirable disease control rate for afatinib of 25%.||23.9|4.9|0.6394
72607080|NCT00549549|144742210|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.19|STANDARD_ERROR_OF_MEAN|0.16|||TWO_SIDED|95.0|-0.5|0.11|||ANCOVA|||Day 12 analyses||0.11|-0.50|
72607081|NCT00549549|144742210|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.24|STANDARD_ERROR_OF_MEAN|0.16|||TWO_SIDED|95.0|-0.56|0.07|||ANCOVA|||Day 13/Early Termination analyses||0.07|-0.56|
72607082|NCT00549549|144742210|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|0.16|||TWO_SIDED|95.0|-0.81|-0.19|||ANCOVA|||Day 13/Early Termination analyses||-0.19|-0.81|
72607083|NCT00549549|144742210|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|0.16|||TWO_SIDED|95.0|-0.1|0.51|||ANCOVA|||Day 13/Early Termination analyses||0.51|-0.10|
72325139|NCT00279214|144173572|SUPERIORITY_OR_OTHER|||||||0.238||95.0|||||Repeated Measures - propensity adjusted|||24-Hour p-value||||0.238
72607084|NCT00549549|144742210|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.04|STANDARD_ERROR_OF_MEAN|0.16|||TWO_SIDED|95.0|-0.35|0.26|||ANCOVA|||Day 13/Early Termination analyses||0.26|-0.35|
72607085|NCT00549549|144742210|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.16|||TWO_SIDED|95.0|-0.6|0.01|||ANCOVA|||Day 13/Early Termination analyses||0.01|-0.60|
72607086|NCT00549549|144742211|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.07|STANDARD_ERROR_OF_MEAN|0.11|||TWO_SIDED|95.0|-0.28|0.14|||ANCOVA|||The analysis was conducted using analysis of covariance (ANCOVA) with randomization stratum (2 levels: monoarticular or oligoarticular) and treatment group as factors, and the Patient's Assessment of Pain Intensity at Baseline as a covariate.||0.14|-0.28|
72607087|NCT00549549|144742211|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.18|STANDARD_ERROR_OF_MEAN|0.11|||TWO_SIDED|95.0|-0.39|0.03|||ANCOVA|||Day 1, 2 hours postdose||0.03|-0.39|
72607088|NCT00549549|144742211|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.31|STANDARD_ERROR_OF_MEAN|0.1|||TWO_SIDED|95.0|0.11|0.52|||ANCOVA|||Day 1, 2 hours postdose||0.52|0.11|
72607089|NCT00549549|144742211|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.24|STANDARD_ERROR_OF_MEAN|0.1|||TWO_SIDED|95.0|0.04|0.45|||ANCOVA|||Day 1, 2 hours postdose||0.45|0.04|
72607090|NCT00549549|144742211|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.13|STANDARD_ERROR_OF_MEAN|0.11|||TWO_SIDED|95.0|-0.08|0.34|||ANCOVA|||Day 1, 2 hours postdose||0.34|-0.08|
72607091|NCT00549549|144742211|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.14|STANDARD_ERROR_OF_MEAN|0.11|||TWO_SIDED|95.0|-0.37|0.08|||ANCOVA|||Day 1, 4 hours postdose||0.08|-0.37|
72607092|NCT00549549|144742211|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.25|STANDARD_ERROR_OF_MEAN|0.11|||TWO_SIDED|95.0|-0.48|-0.03|||ANCOVA|||Day 1, 4 hours postdose||-0.03|-0.48|
72607093|NCT00549549|144742211|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.36|STANDARD_ERROR_OF_MEAN|0.11|||TWO_SIDED|95.0|0.14|0.58|||ANCOVA|||Day 1, 4 hours postdose||0.58|0.14|
72607094|NCT00549549|144742211|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.22|STANDARD_ERROR_OF_MEAN|0.11|||TWO_SIDED|95.0|0.0|0.44|||ANCOVA|||Day 1, 4 hours postdose||0.44|0.00|
72607095|NCT00549549|144742211|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.11|STANDARD_ERROR_OF_MEAN|0.11|||TWO_SIDED|95.0|-0.11|0.34|||ANCOVA|||Day 1, 4 hours postdose||0.34|-0.11|
72607096|NCT00549549|144742211|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.07|STANDARD_ERROR_OF_MEAN|0.12|||TWO_SIDED|95.0|-0.32|0.17|||ANCOVA|||Day 1, 8 hours postdose||0.17|-0.32|
72416805|NCT05554237|144344274|OTHER||Ratio of adjusted geometric mean|102.85|||||TWO_SIDED|90.0|94.8|111.58|||||Analysis was performed using mixed effect model with treatment as a fixed effect and participant as a random effect (fed vs fasted)|HPA- Day 6 versus Day 7||111.58|94.80|
72607097|NCT00549549|144742211|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.31|STANDARD_ERROR_OF_MEAN|0.13|||TWO_SIDED|95.0|-0.56|-0.06|||ANCOVA|||Day 1, 8 hours postdose||-0.06|-0.56|
72607098|NCT00549549|144742211|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.42|STANDARD_ERROR_OF_MEAN|0.12|||TWO_SIDED|95.0|0.18|0.67|||ANCOVA|||Day 1, 8 hours postdose||0.67|0.18|
72607099|NCT00549549|144742211|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.35|STANDARD_ERROR_OF_MEAN|0.12|||TWO_SIDED|95.0|0.11|0.59|||ANCOVA|||Day 1, 8 hours postdose||0.59|0.11|
72607100|NCT00549549|144742211|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.11|STANDARD_ERROR_OF_MEAN|0.12|||TWO_SIDED|95.0|-0.13|0.36|||ANCOVA|||Day 1, 8 hours postdose||0.36|-0.13|
72607101|NCT00549549|144742211|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.16|STANDARD_ERROR_OF_MEAN|0.13|||TWO_SIDED|95.0|-0.42|0.1|||ANCOVA|||Day 1, 12 hours postdose||0.10|-0.42|
72607102|NCT00549549|144742211|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.37|STANDARD_ERROR_OF_MEAN|0.13|||TWO_SIDED|95.0|-0.63|-0.11|||ANCOVA|||Day 1, 12 hours postdose||-0.11|-0.63|
72607103|NCT00549549|144742211|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.45|STANDARD_ERROR_OF_MEAN|0.13|||TWO_SIDED|95.0|0.19|0.7|||ANCOVA|||Day 1, 12 hours postdose||0.70|0.19|
72607104|NCT00549549|144742211|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.29|STANDARD_ERROR_OF_MEAN|0.13|||TWO_SIDED|95.0|0.03|0.55|||ANCOVA|||Day 1, 12 hours postdose||0.55|0.03|
72607105|NCT00549549|144742211|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.08|STANDARD_ERROR_OF_MEAN|0.13|||TWO_SIDED|95.0|-0.18|0.34|||ANCOVA|||Day 1, 12 hours postdose||0.34|-0.18|
72607106|NCT00549549|144742211|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.19|STANDARD_ERROR_OF_MEAN|0.13|||TWO_SIDED|95.0|-0.46|0.07|||ANCOVA|||Day 2, 0 hours postdose||0.07|-0.46|
72607107|NCT00549549|144742211|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.31|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|-0.57|-0.04|||ANCOVA|||Day 2, 0 hours postdose||-0.04|-0.57|
72607108|NCT00549549|144742211|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.42|STANDARD_ERROR_OF_MEAN|0.13|||TWO_SIDED|95.0|0.16|0.68|||ANCOVA|||Day 2, 0 hours postdose||0.68|0.16|
72607109|NCT00549549|144742211|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.23|STANDARD_ERROR_OF_MEAN|0.13|||TWO_SIDED|95.0|-0.04|0.49|||ANCOVA|||Day 2, 0 hours postdose||0.49|-0.04|
72607110|NCT00549549|144742211|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.11|STANDARD_ERROR_OF_MEAN|0.13|||TWO_SIDED|95.0|-0.15|0.38|||ANCOVA|||Day 2, 0 hours postdose||0.38|-0.15|
72607111|NCT00549549|144742211|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.13|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|-0.4|0.14|||ANCOVA|||Day 2, 8 hours postdose||0.14|-0.40|
72607112|NCT00549549|144742211|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.32|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|-0.59|-0.05|||ANCOVA|||Day 2, 8 hours postdose||-0.05|-0.59|
72607113|NCT00549549|144742211|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.47|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|0.2|0.74|||ANCOVA|||Day 2, 8 hours postdose||0.74|0.20|
72607114|NCT00549549|144742211|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.34|STANDARD_ERROR_OF_MEAN|0.13|||TWO_SIDED|95.0|0.08|0.61|||ANCOVA|||Day 2, 8 hours postdose||0.61|0.08|
72607115|NCT00549549|144742211|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.15|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|-0.11|0.42|||ANCOVA|||Day 2, 8 hours postdose||0.42|-0.11|
72607116|NCT00549549|144742212|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|0.09|STANDARD_ERROR_OF_MEAN|0.09|||TWO_SIDED|95.0|-0.09|0.27|||ANCOVA|||8 hour postdose analysis. The analysis was conducted using analysis of covariance (ANCOVA) with randomization stratum (2 levels: monoarticular or oligoarticular) and treatment group as factors, and the Patient's Assessment of Pain Intensity at Baseline as a covariate.||0.27|-0.09|
72607117|NCT00549549|144742212|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.22|STANDARD_ERROR_OF_MEAN|0.09|||TWO_SIDED|95.0|0.04|0.4|||ANCOVA|||8 hour postdose analysis||0.40|0.04|
72607118|NCT00549549|144742212|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.32|STANDARD_ERROR_OF_MEAN|0.09|||TWO_SIDED|95.0|-0.5|-0.14|||ANCOVA|||8 hour postdose analysis||-0.14|-0.50|
72607119|NCT00549549|144742212|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.23|STANDARD_ERROR_OF_MEAN|0.09|||TWO_SIDED|95.0|-0.41|-0.05|||ANCOVA|||8 hour postdose analysis||-0.05|-0.41|
72607120|NCT00549549|144742212|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.09|||TWO_SIDED|95.0|-0.28|0.08|||ANCOVA|||8 hour postdose analysis||0.08|-0.28|
72607121|NCT00549549|144742212|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.1|||TWO_SIDED|95.0|-0.1|0.29|||ANCOVA|||12 hour postdose analysis||0.29|-0.10|
72607122|NCT00549549|144742212|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.26|STANDARD_ERROR_OF_MEAN|0.1|||TWO_SIDED|95.0|0.06|0.45|||ANCOVA|||12 hour postdose analysis||0.45|0.06|
72607123|NCT00549549|144742212|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.36|STANDARD_ERROR_OF_MEAN|0.1|||TWO_SIDED|95.0|-0.55|-0.16|||ANCOVA|||12 hour postdose analysis||-0.16|-0.55|
72607124|NCT00549549|144742212|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.26|STANDARD_ERROR_OF_MEAN|0.1|||TWO_SIDED|95.0|-0.45|-0.07|||ANCOVA|||12 hour postdose analysis||-0.07|-0.45|
72607125|NCT00549549|144742212|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.1|||TWO_SIDED|95.0|-0.29|0.09|||ANCOVA|||12 hour postdose analysis||0.09|-0.29|
72607126|NCT00549549|144742212|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.14|STANDARD_ERROR_OF_MEAN|0.11|||TWO_SIDED|95.0|-0.08|0.35|||ANCOVA|||24 hour postdose analysis||0.35|-0.08|
72607127|NCT00549549|144742212|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.29|STANDARD_ERROR_OF_MEAN|0.11|||TWO_SIDED|95.0|0.08|0.51|||ANCOVA|||24 hour postdose analysis||0.51|0.08|
72607128|NCT00549549|144742212|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.11|||TWO_SIDED|95.0|-0.61|-0.18|||ANCOVA|||24 hour postdose analysis||-0.18|-0.61|
72607129|NCT00549549|144742212|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.26|STANDARD_ERROR_OF_MEAN|0.11|||TWO_SIDED|95.0|-0.47|-0.05|||ANCOVA|||24 hour postdose analysis||-0.05|-0.47|
72607130|NCT00549549|144742212|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.11|||TWO_SIDED|95.0|-0.32|0.11|||ANCOVA|||24 hour postdose analysis||0.11|-0.32|
72325140|NCT00279214|144173572|SUPERIORITY_OR_OTHER|||||||0.281||95.0||||24-Hour Change from Baseline p-value|Repeated Measures - propensity adjusted|||||||0.281
72607131|NCT00549549|144742213|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0459|TWO_SIDED||||||Cochran-Mantel-Haenszel|||\>=30% reduction analyses. The analysis was conducted using analysis of covariance (ANCOVA) with randomization stratum (2 levels: monoarticular or oligoarticular) and treatment group as factors, and the Patient's Assessment of Pain Intensity at Baseline as a covariate.||||0.0459
72607132|NCT00549549|144742213|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0017|TWO_SIDED||||||Cochran-Mantel-Haenszel|||\>=30% reduction analyses||||0.0017
72607133|NCT00549549|144742213|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||\>=30% reduction analyses||||0.0001
72607134|NCT00549549|144742213|SUPERIORITY_OR_OTHER_LEGACY|||||||0.041|TWO_SIDED||||||Cochran-Mantel-Haenszel|||\>=30% reduction analyses||||0.0410
72607135|NCT00549549|144742213|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5592|TWO_SIDED||||||Cochran-Mantel-Haenszel|||\>=30% reduction analyses||||0.5592
72607136|NCT00549549|144742213|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0277|TWO_SIDED||||||Cochran-Mantel-Haenszel|||\>=50% reduction analyses||||0.0277
72607137|NCT00549549|144742213|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0018|TWO_SIDED||||||Cochran-Mantel-Haenszel|||\>=50% reduction analyses||||0.0018
72607138|NCT00549549|144742213|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||\>=50% reduction analyses||||<.0001
72607139|NCT00549549|144742213|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0394|TWO_SIDED||||||Cochran-Mantel-Haenszel|||\>=50% reduction analyses||||0.0394
72607140|NCT00549549|144742213|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4603|TWO_SIDED||||||Cochran-Mantel-Haenszel|||\>=50% reduction analyses||||0.4603
72607141|NCT00549549|144742216|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5528|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Withdrawal on Day 1. Pairwise p-values are presented, calculated using Cochran-Mantel-Haenszel statistics, stratified by number of affected joints \[1 or \>1\]) and region.||||0.5528
72607142|NCT00549549|144742216|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1779|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Withdrawal on Day 1. Pairwise p-values are presented, calculated using Cochran-Mantel-Haenszel statistics, stratified by number of affected joints \[1 or \>1\]) and region.||||0.1779
72607143|NCT00549549|144742216|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1754|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Withdrawal on Day 1. Pairwise p-values are presented, calculated using Cochran-Mantel-Haenszel statistics, stratified by number of affected joints \[1 or \>1\]) and region.||||0.1754
72607144|NCT00549549|144742216|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3384|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Withdrawal on Day 1. Pairwise p-values are presented, calculated using Cochran-Mantel-Haenszel statistics, stratified by number of affected joints \[1 or \>1\]) and region.||||0.3384
72607145|NCT00549549|144742216|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5005|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Withdrawal on any time during treatment. Pairwise p-values are presented, calculated using Cochran-Mantel-Haenszel statistics, stratified by number of affected joints \[1 or \>1\]) and region.||||0.5005
72607146|NCT00549549|144742216|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0845|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Withdrawal on any time during treatment. Pairwise p-values are presented, calculated using Cochran-Mantel-Haenszel statistics, stratified by number of affected joints \[1 or \>1\]) and region.||||0.0845
72607147|NCT00549549|144742216|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0213|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Withdrawal on any time during treatment. Pairwise p-values are presented, calculated using Cochran-Mantel-Haenszel statistics, stratified by number of affected joints \[1 or \>1\]) and region.||||0.0213
72607148|NCT00549549|144742216|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1231|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Withdrawal on any time during treatment. Pairwise p-values are presented, calculated using Cochran-Mantel-Haenszel statistics, stratified by number of affected joints \[1 or \>1\]) and region.||||0.1231
72416806|NCT05554237|144344289|OTHER||Ratio of adjusted geometric mean|105.47|||||TWO_SIDED|90.0|86.64|128.39|||||Analysis was performed using mixed effect model with treatment as a fixed effect and participant as a random effect (Japanese participants fed vs fasted and Chinese participants fed vs fasted)|AVI- Day 6 versus Day 7||128.39|86.64|
72607149|NCT00549549|144742216|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6636|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Withdrawal on any time during treatment. Pairwise p-values are presented, calculated using Cochran-Mantel-Haenszel statistics, stratified by number of affected joints \[1 or \>1\]) and region.||||0.6636
72607150|NCT00549549|144742216|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5378|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Withdrawal on any time during study. Pairwise p-values are presented, calculated using Cochran-Mantel-Haenszel statistics, stratified by number of affected joints \[1 or \>1\]) and region.||||0.5378
72607151|NCT00549549|144742216|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0818|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Withdrawal on any time during study. Pairwise p-values are presented, calculated using Cochran-Mantel-Haenszel statistics, stratified by number of affected joints \[1 or \>1\]) and region.||||0.0818
72607152|NCT00549549|144742216|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0317|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Withdrawal on any time during study. Pairwise p-values are presented, calculated using Cochran-Mantel-Haenszel statistics, stratified by number of affected joints \[1 or \>1\]) and region.||||0.0317
72607153|NCT00549549|144742216|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1592|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Withdrawal on any time during study. Pairwise p-values are presented, calculated using Cochran-Mantel-Haenszel statistics, stratified by number of affected joints \[1 or \>1\]) and region.||||0.1592
72607154|NCT00549549|144742216|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7956|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Withdrawal on any time during study. Pairwise p-values are presented, calculated using Cochran-Mantel-Haenszel statistics, stratified by number of affected joints \[1 or \>1\]) and region.||||0.7956
72607155|NCT00549549|144742217|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.07|STANDARD_ERROR_OF_MEAN|0.12|||TWO_SIDED|95.0|-0.17|0.31|||ANCOVA|||The analysis was conducted using analysis of covariance (ANCOVA) with randomization stratum (2 levels: monoarticular or oligoarticular) and treatment group as factors, and the Patient's Assessment of Pain Intensity at Baseline as a covariate.||0.31|-0.17|
72325141|NCT00279214|144173573|SUPERIORITY_OR_OTHER|||||||0.478||95.0||||P-value for 96 Hour Change from Baseline.|Mixed Models Analysis|Model: Outcome=Therapy + Sedative Indicator + Time + Therapy\*Time + Propensity Score||||||0.478
72416807|NCT05554237|144344289|OTHER||Ratio of adjusted geometric mean|134.24||||||90.0|51.81|347.81|||||Analysis was performed using mixed effect model with treatment as a fixed effect and participant as a random effect (Japanese participants fed vs fasted and Chinese participants fed vs fasted)|AVI- Day 6 versus Day 7||347.81|51.81|
72325142|NCT00279214|144173574|SUPERIORITY_OR_OTHER|||||||0.442||95.0||||24-Hour p-value|Repeated Measures - propensity adjusted|||||||0.442
72607156|NCT00549549|144742217|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.22|STANDARD_ERROR_OF_MEAN|0.12|||TWO_SIDED|95.0|-0.02|0.46|||ANCOVA|||||0.46|-0.02|
72607157|NCT00549549|144742217|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.26|STANDARD_ERROR_OF_MEAN|0.12|||TWO_SIDED|95.0|-0.5|-0.02|||ANCOVA|||||-0.02|-0.50|
72607158|NCT00549549|144742217|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.19|STANDARD_ERROR_OF_MEAN|0.12|||TWO_SIDED|95.0|-0.43|0.05|||ANCOVA|||||0.05|-0.43|
72607159|NCT00549549|144742217|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.04|STANDARD_ERROR_OF_MEAN|0.12|||TWO_SIDED|95.0|-0.28|0.19|||ANCOVA|||||0.19|-0.28|
72607160|NCT00549549|144742218|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3173|TWO_SIDED||||||Cochran-Mantel-Haenszel|||p-value calculated using Cochran-Mantel-Haenszel statistics, stratified by number of affected joints \[1; \>1\], and region.||||0.3173
72607161|NCT00549549|144742219|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4724|TWO_SIDED||||||Cochran-Mantel-Haenszel|||p-value calculated using Cochran-Mantel-Haenszel statistics, stratified by number of affected joints \[1; \>1\], and region.||||0.4724
72607162|NCT00549549|144742219|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7316|TWO_SIDED||||||Cochran-Mantel-Haenszel|||p-value calculated using Cochran-Mantel-Haenszel statistics, stratified by number of affected joints \[1; \>1\], and region.||||0.7316
72607163|NCT00549549|144742219|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7316|TWO_SIDED||||||Cochran-Mantel-Haenszel|||p-value calculated using Cochran-Mantel-Haenszel statistics, stratified by number of affected joints \[1; \>1\], and region.||||0.7316
72607164|NCT02227784|144742224|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-33.48|||<|0.001|TWO_SIDED|95.0|-44.4|-23.3|||ANCOVA|||||-23.3|-44.4|<0.001
72607165|NCT02227784|144742224|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-27.24|||<|0.001|TWO_SIDED|95.0|-36.6|-18.5|||ANCOVA|||||-18.5|-36.6|<0.001
72607166|NCT02227784|144742224|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-6.14||||0.045|TWO_SIDED|95.0|-12.2|-0.22|||ANCOVA|||||-0.22|-12.2|0.045
72607167|NCT02227784|144742225|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|125.28|||<|0.001|TWO_SIDED|95.0|117.1|133.6|||Mixed Models Analysis|||||133.6|117.1|<0.001
72607168|NCT02227784|144742225|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|131.48|||<|0.001|TWO_SIDED|95.0|123.5|139.5|||Mixed Models Analysis|||||139.5|123.5|<0.001
72607169|NCT02227784|144742225|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|127.57|||<|0.001|TWO_SIDED|95.0|120.1|135.0|||Mixed Models Analysis|||||135.0|120.1|<0.001
72607170|NCT02227784|144742226|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|46.35|||<|0.001|TWO_SIDED|95.0|40.79|51.98|||ANCOVA|||||51.98|40.79|<0.001
72416808|NCT05554237|144344289|OTHER||Ratio of adjusted geometric mean|91.17||||||90.0|79.54|104.51|||||Analysis was performed using mixed effect model with treatment as a fixed effect and participant as a random effect (Japanese participants fed vs fasted and Chinese participants fed vs fasted)|HPA- Day 6 versus Day 7||104.51|79.54|
72416809|NCT05554237|144344289|OTHER||Ratio of adjusted geometric mean|115.26|||||TWO_SIDED|90.0|71.46|185.9|||||Analysis was performed using mixed effect model with treatment as a fixed effect and participant as a random effect (Japanese participants fed vs fasted and Chinese participants fed vs fasted)|HPA- Day 6 versus Day 7||185.90|71.46|
72416810|NCT05554237|144344291|OTHER||Ratio of adjusted geometric mean|114.83|||||TWO_SIDED|90.0|101.1|130.43|||||Analysis was performed using mixed effect model with treatment as a fixed effect and participant as a random effect (Japanese participants fed vs fasted and Chinese participants fed vs fasted)|AVI- Day 6 versus Day 7||130.43|101.10|
72607171|NCT02227784|144742226|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|52.22|||<|0.001|TWO_SIDED|95.0|47.12|57.33|||ANCOVA|||||57.33|47.12|<0.001
72607172|NCT02227784|144742226|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|48.44|||<|0.001|TWO_SIDED|95.0|43.82|52.86|||ANCOVA|||||52.86|43.82|<0.001
72416811|NCT05554237|144344291|OTHER||Ratio of adjusted geometric mean|140.44|||||TWO_SIDED|90.0|104.17|189.34|||||Analysis was performed using mixed effect model with treatment as a fixed effect and participant as a random effect (Japanese participants fed vs fasted and Chinese participants fed vs fasted)|AVI- Day 6 versus Day 7||189.34|104.17|
72416812|NCT05554237|144344291|OTHER||Ratio of adjusted geometric mean|101.46||||||90.0|90.79|113.39|||||Analysis was performed using mixed effect model with treatment as a fixed effect and participant as a random effect (Japanese participants fed vs fasted and Chinese participants fed vs fasted)|HPA- Day 6 versus Day 7||113.39|90.79|
72416813|NCT05554237|144344291|OTHER||Ratio of adjusted geometric means|123.2|||||TWO_SIDED|90.0|110.25|137.67|||||Model is a mixed effect model with treatment as a fixed effect and participant as a random effect (Japanese participants fed vs fasted and Chinese participants fed vs fasted)|HPA- Day 6 versus Day 7||137.67|110.25|
72607173|NCT02227784|144742227|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-26.47|||<|0.001|TWO_SIDED|95.0|-33.4|-20.0|||Mixed Models Analysis|||||-20.0|-33.4|<0.001
72607174|NCT02227784|144742227|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-22.02|||<|0.001|TWO_SIDED|95.0|-28.4|-15.9|||Mixed Models Analysis|||||-15.9|-28.4|<0.001
72607175|NCT02227784|144742227|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-7.05|||<|0.001|TWO_SIDED|95.0|-11.5|-2.68|||Mixed Models Analysis|||||-2.68|-11.5|<0.001
72607176|NCT02227784|144742228|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-23.16|||<|0.001|TWO_SIDED|95.0|-30.0|-16.5|||ANCOVA|||||-16.5|-30.00|<0.001
72416814|NCT04435366|144344309|SUPERIORITY||Least Squares Mean Difference|0.056|STANDARD_ERROR_OF_MEAN|0.02||0.0064|TWO_SIDED|95.0|0.016|0.096||Nominal p-value was used for the comparison between avacincaptad pegol versus sham.|MMRM|||Difference in least squares mean between groups calculated as (sham) minus (avacincaptad pegol). Mixed Model for repeated measures (MMRM) was used to compare the treatment groups.||0.096|0.016|0.0064
72416815|NCT04435366|144344310|SUPERIORITY||Least Squares Mean Difference|0.362|STANDARD_ERROR_OF_MEAN|0.15||0.0165|TWO_SIDED|95.0|0.066|0.657||Nominal p-value was used for the comparison between avacincaptad pegol versus sham.|MMRM|||Difference in least squares mean between groups calculated as (sham) minus (avacincaptad pegol).||0.657|0.066|0.0165
72607177|NCT02227784|144742228|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-16.42|||<|0.001|TWO_SIDED|95.0|-22.3|-10.6|||ANCOVA|||||-10.6|-22.3|<0.001
72607178|NCT02227784|144742228|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-4.11||||0.062|TWO_SIDED|95.0|-8.47|0.15|||ANCOVA|||||0.15|-8.47|0.062
72607179|NCT02227784|144742229|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|38.05|||<|0.001|TWO_SIDED|95.0|30.17|45.88|||ANCOVA|||||45.88|30.17|<0.001
72607180|NCT02227784|144742229|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|42.12|||<|0.001|TWO_SIDED|95.0|34.29|49.76|||ANCOVA|||||49.76|34.29|<0.001
72607181|NCT02227784|144742229|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|39.64|||<|0.001|TWO_SIDED|95.0|33.2|46.08|||ANCOVA|||||46.08|33.20|<0.001
72607182|NCT02227784|144742230|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-33.18|||<|0.001|TWO_SIDED|95.0|-44.9|-22.3|||ANCOVA|||||-22.3|-44.9|<0.001
72607183|NCT02227784|144742230|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-32.63|||<|0.001|TWO_SIDED|95.0|-44.0|-21.8|||ANCOVA|||||-21.8|-44.0|<0.001
72607184|NCT02227784|144742230|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-42.15|||<|0.001|TWO_SIDED|95.0|-50.9|-33.4|||ANCOVA|||||-33.4|-50.9|<0.001
72607185|NCT00248651|144742242|SUPERIORITY_OR_OTHER|||||||0.05|||||||ANCOVA|||Overall treatment effect from logistic regression model incorporating balancing factors. A p-value of \<0.05 was considered statistically significant.||||0.05
72607186|NCT00248651|144742245|SUPERIORITY_OR_OTHER|||||||0.02|||||||ANCOVA|||Comparison between antidepressant arms and placebo for overall quality of life. A p-value of \<0.05 was considered statistically significant.||||0.02
72607187|NCT00248651|144742245|SUPERIORITY_OR_OTHER|||||||0.06|||||||ANCOVA|||Comparison between antidepressant arms and placebo for Eat/Drink subscale. A p-value of \<0.05 was considered statistically significant.||||0.06
72607188|NCT00248651|144742245|SUPERIORITY_OR_OTHER|||||||0.06|||||||ANCOVA|||Comparison between antidepressant arms and placebo for Interference subscale. A p-value of \<0.05 was considered statistically significant.||||0.06
72607189|NCT00248651|144742245|SUPERIORITY_OR_OTHER|||||||0.01|||||||ANCOVA|||Comparison between antidepressant arms and placebo for Sleep Disturbance subscale. A p-value of \<0.05 was considered statistically significant.||||0.01
72607190|NCT00248651|144742245|SUPERIORITY_OR_OTHER|||||||0.04|||||||ANCOVA|||Comparison between antidepressant arms and placebo for Work/Study subscale. A p-value of \<0.05 was considered statistically significant.||||0.04
72607191|NCT02688933|144742251|SUPERIORITY||Least Square mean difference|0.22|STANDARD_ERROR_OF_MEAN|1.15||0.8494|TWO_SIDED|||||Threshold for significance at 0.05 level.|Generalized linear model|Generalized linear model with identity link||Analysis was performed using generalized linear model with identity link, had percentage of time glucose concentration within target range 70-180 mg/dL as dependent variable, treatment group as an independent variable, adjusting variables including baseline characteristics: duration of diabetes, baseline BMI, age, and randomization strata (HbA1c at screening \[\<8.0% vs ≥8.0%\], frequency of Lantus injection at screening, current CGM use \[yes/no\], and mealtime insulin titration algorithm).||||0.8494
72607192|NCT01275144|144742259|SUPERIORITY_OR_OTHER||Ratio of geometric least square mean|0.897|||||TWO_SIDED|90.0|0.86|0.94|||||Ratio of LY2216684 to Placebo|||0.94|0.86|
72607193|NCT01275144|144742260|SUPERIORITY_OR_OTHER||median of paired differences|0.5||||0.0021|TWO_SIDED|90.0|0.5|1.0|||Wilcoxon signed rank test||Ratio of LY2216684 to Placebo|||1.00|0.50|0.0021
72607194|NCT01275144|144742261|SUPERIORITY_OR_OTHER||Ratio of geometric least square mean|1.04|||||TWO_SIDED|90.0|1.01|1.08|||||Ratio of LY2216684 to Placebo|||1.08|1.01|
72607195|NCT05607576|144742289|OTHER|Clarke error grid analyses (EGA) were performed to compare CGM values to glucometer glucose values blood glucose readings (mg/dL) were grouped based on radiation exposure (\>0-500 µGy and \>500 µGy). A p-value \<0.05 was considered statistically significant.|||||<|0.05|||||||Mixed Models Analysis|Generalized linear mixed models with random effects were used to assess absolute differences in BG mg/dL by cumulative scatter||||||<0.05
72607196|NCT05607576|144742290|OTHER|Clarke error grid analyses (EGA) were performed to compare CGM values to glucometer glucose values. A p-value \<0.05 was considered statistically significant.|||||<|0.05|||||||Mixed Models Analysis|Generalized linear mixed models with random effects over time were used to assess absolute differences in BG mg/dL by time||||||<0.05
72607197|NCT00810199|144742291|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.26||||0.2055|TWO_SIDED|95.0|0.882|1.799||Cochran-Mantel-Haenszel test stratified by region and baseline DAS28 (≤5.5 and \>5.5).|Cochran-Mantel-Haenszel|||||1.799|0.882|0.2055
72607198|NCT00810199|144742291|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.27||||0.1894|TWO_SIDED|95.0|0.889|1.814||Logistic regression including treatment , region and baseline DAS28.|Regression, Logistic|Odds ratio is for Tocilizumab + Methotrexate relative to Tocilizumab + Placebo.||||1.814|0.889|0.1894
72607199|NCT00810199|144742292|SUPERIORITY_OR_OTHER|||||||0.8742||95.0|||||Cochran-Mantel-Haenszel|Region and baseline DAS28 (≤5.5 and \>5.5) included as stratification variables.||Week 24||||0.8742
72607200|NCT00810199|144742292|SUPERIORITY_OR_OTHER|||||||0.6212||95.0|||||Cochran-Mantel-Haenszel|Region and baseline DAS28 (≤5.5 and \>5.5) included as stratification variables.||Week 52||||0.6212
72607201|NCT00810199|144742292|SUPERIORITY_OR_OTHER|||||||0.0963||95.0|||||Cochran-Mantel-Haenszel|Region and baseline DAS28 (≤5.5 and \>5.5) included as stratification variables.||Week 104||||0.0963
72607202|NCT00810199|144742293|SUPERIORITY_OR_OTHER|||||||0.2969||95.0|||||Cochran-Mantel-Haenszel|Region and baseline DAS28 (≤5.5 and \>5.5) included as stratification variables.||Week 24||||0.2969
72416816|NCT04435366|144344310|SUPERIORITY||Least Squares Mean Difference|0.488|STANDARD_ERROR_OF_MEAN|0.152||0.0015|TWO_SIDED|95.0|0.189|0.788||Nominal p-value was used for the comparison between avacincaptad pegol and sham versus sham.|MMRM|||Difference in least squares mean between groups calculated as (sham) minus (avacincaptad pegol and sham).||0.788|0.189|0.0015
72607203|NCT00810199|144742293|SUPERIORITY_OR_OTHER|||||||0.2215||95.0|||||Cochran-Mantel-Haenszel|Region and baseline DAS28 (≤5.5 and \>5.5) included as stratification variables.||Week 52||||0.2215
72607204|NCT00810199|144742293|SUPERIORITY_OR_OTHER|||||||0.1243||95.0|||||Cochran-Mantel-Haenszel|Region and baseline DAS28 (≤5.5 and \>5.5) included as stratification variables.||Week 104||||0.1243
72607205|NCT00810199|144742294|SUPERIORITY_OR_OTHER|||||||0.6775||95.0|||||Cochran-Mantel-Haenszel|Region and baseline DAS28 (≤5.5 and \>5.5) included as stratification variables.||Week 24||||0.6775
72607206|NCT00810199|144742294|SUPERIORITY_OR_OTHER|||||||0.9976||95.0|||||Cochran-Mantel-Haenszel|Region and baseline DAS28 (≤5.5 and \>5.5) included as stratification variables.||Week 52||||0.9976
72607207|NCT00810199|144742294|SUPERIORITY_OR_OTHER|||||||0.2168||95.0|||||Cochran-Mantel-Haenszel|Region and baseline DAS28 (≤5.5 and \>5.5) included as stratification variables.||Week 104||||0.2168
72607208|NCT00810199|144742295|SUPERIORITY_OR_OTHER|||||||0.8369||95.0|||||Cochran-Mantel-Haenszel|Region and baseline DAS28 (≤5.5 and \>5.5) included as stratification variables.||Week 24||||0.8369
72607209|NCT00810199|144742295|SUPERIORITY_OR_OTHER|||||||0.6528||95.0|||||Cochran-Mantel-Haenszel|Region and baseline DAS28 (≤5.5 and \>5.5) included as stratification variables.||Week 52||||0.6528
72607210|NCT00810199|144742295|SUPERIORITY_OR_OTHER|||||||0.2546||95.0|||||Cochran-Mantel-Haenszel|Region and baseline DAS28 (≤5.5 and \>5.5) included as stratification variables.||Week 104||||0.2546
72607211|NCT00810199|144742296|SUPERIORITY_OR_OTHER|||||||0.1018|||||||Log Rank|||||||0.1018
72607212|NCT00810199|144742297|SUPERIORITY_OR_OTHER|||||||0.7176|||||||Log Rank|||||||0.7176
72607213|NCT00810199|144742298|SUPERIORITY_OR_OTHER|||||||0.8526|||||||Log Rank|||||||0.8526
72607214|NCT00810199|144742299|SUPERIORITY_OR_OTHER|||||||0.2217|||||||Log Rank|||||||0.2217
72607215|NCT00810199|144742300|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.26||||0.0008|TWO_SIDED|95.0|-0.41|-0.11|||ANCOVA|Baseline DAS28 as a covariate.||||-0.11|-0.41|0.0008
72607216|NCT00810199|144742301|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.49||||0.0245|TWO_SIDED|95.0|1.053|2.109|||Regression, Logistic|Logistic regression including treatment, region and baseline DAS28.|Odds ratio is for Tocilizumab + Methotrexate relative to Tocilizumab + Placebo.|||2.109|1.053|0.0245
72607217|NCT00810199|144742301|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.482||||0.0258||95.0|1.048|2.095||Stratified by region and baseline DAS28 (≤ 5.5 and \> 5.5).|Cochran-Mantel-Haenszel|||||2.095|1.048|0.0258
72607218|NCT00810199|144742302|SUPERIORITY_OR_OTHER|||||||0.0287||95.0|||||Wald Chi-square|Asymptotic test; parameter estimate is zero.||Week 24||||0.0287
72607219|NCT00810199|144742302|SUPERIORITY_OR_OTHER|||||||0.224|||||||Wald Chi-square|Asymptotic test; parameter estimate is zero.||Week 52||||0.2240
72607220|NCT00810199|144742303|SUPERIORITY_OR_OTHER|||||||0.0497||95.0|||||Wilcoxon (Mann-Whitney)|||Week 24||||0.0497
72607221|NCT00810199|144742303|SUPERIORITY_OR_OTHER|||||||0.3918|||||||Wilcoxon (Mann-Whitney)|||Week 52||||0.3918
72607222|NCT00810199|144742304|SUPERIORITY_OR_OTHER|||||||0.0019||95.0|||||Cochran-Mantel-Haenszel|Region and baseline DAS28 (≤5.5 and \>5.5) included as stratification variables.||Week 24||||0.0019
72607223|NCT00810199|144742304|SUPERIORITY_OR_OTHER|||||||0.1181|||||||Cochran-Mantel-Haenszel|Region and baseline DAS28 (≤5.5 and \>5.5) included as stratification variables.||Week 52||||0.1181
72607224|NCT00810199|144742305|SUPERIORITY_OR_OTHER|||||||0.7776||||||P-value is from a 2-sided, Wilcoxon rank-sum test of no difference between the 2 treatment groups in change from baseline.|Wilcoxon (Mann-Whitney)|||Week 24||||0.7776
72607225|NCT00810199|144742305|SUPERIORITY_OR_OTHER|||||||0.8843|||||||Wilcoxon (Mann-Whitney)|||Week 52||||0.8843
72607226|NCT00810199|144742306|SUPERIORITY_OR_OTHER|||||||0.9095||95.0|||||Wilcoxon (Mann-Whitney)|||Week 24||||0.9095
72607227|NCT00810199|144742306|SUPERIORITY_OR_OTHER|||||||0.7179|||||||Wilcoxon (Mann-Whitney)|||Week 52||||0.7179
72607228|NCT00810199|144742307|SUPERIORITY_OR_OTHER|||||||0.3113||95.0|||||Wilcoxon (Mann-Whitney)|||Week 24||||0.3113
72607229|NCT00810199|144742307|SUPERIORITY_OR_OTHER|||||||0.2931||95.0|||||Wilcoxon (Mann-Whitney)|||Week 52||||0.2931
72607230|NCT00810199|144742308|SUPERIORITY_OR_OTHER|||||||0.2451||95.0||||P-value is from a 2-sided, Wilcoxon rank-sum test of no difference between the 2 treatment groups in change from baseline.|Wilcoxon (Mann-Whitney)|||Week 24||||0.2451
72607231|NCT00810199|144742308|SUPERIORITY_OR_OTHER|||||||0.8841||95.0|||||Wilcoxon (Mann-Whitney)|||Week 52||||0.8841
72416817|NCT04435366|144344311|SUPERIORITY||Least Squares Mean Difference|-0.83|STANDARD_ERROR_OF_MEAN|1.5||0.58|TWO_SIDED|95.0|-3.79|2.12||Nominal p-value was used for the comparison between avacincaptad pegol versus sham.|MMRM|||Difference in least squares mean between groups calculated as (sham) minus (avacincaptad pegol).||2.12|-3.79|0.58
72607232|NCT00810199|144742309|SUPERIORITY_OR_OTHER|||||||0.9655||95.0|||||Wilcoxon (Mann-Whitney)|||Week 24||||0.9655
72607233|NCT00810199|144742309|SUPERIORITY_OR_OTHER|||||||0.0308||95.0|||||Wilcoxon (Mann-Whitney)|||Week 52||||0.0308
72607234|NCT00810199|144742310|SUPERIORITY_OR_OTHER|||||||0.5186||95.0|||||Wilcoxon (Mann-Whitney)|||Week 24||||0.5186
72607235|NCT00810199|144742310|SUPERIORITY_OR_OTHER|||||||0.7706||95.0|||||Wilcoxon (Mann-Whitney)|||Week 52||||0.7706
72607236|NCT00810199|144742311|SUPERIORITY_OR_OTHER|||||||0.6067||95.0|||||Wilcoxon (Mann-Whitney)|||Week 24||||0.6067
72607237|NCT00810199|144742311|SUPERIORITY_OR_OTHER|||||||0.681||95.0|||||Wilcoxon (Mann-Whitney)|||Week 52||||0.6810
72607238|NCT00810199|144742312|SUPERIORITY_OR_OTHER|||||||0.9323||95.0|||||Wilcoxon (Mann-Whitney)|||Week 24||||0.9323
72607239|NCT00810199|144742312|SUPERIORITY_OR_OTHER|||||||0.1448||95.0|||||Wilcoxon (Mann-Whitney)|||Week 52||||0.1448
72607240|NCT00810199|144742313|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.17||||0.2034|TWO_SIDED|95.0|-0.43|0.09||Baseline x-ray and DAS28 as covariates and treatment group and region as fixed effects.|ANCOVA|||Week 24||0.09|-0.43|0.2034
72607241|NCT00810199|144742313|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.28||||0.3611|TWO_SIDED|95.0|-0.88|0.32||Baseline x-ray and DAS28 as covariates and treatment group and region as fixed effects.|ANCOVA|||Week 52||0.32|-0.88|0.3611
72607242|NCT00810199|144742313|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6||||0.0342|TWO_SIDED|95.0|-1.16|-0.05||Baseline x-ray and DAS28 as covariates and treatment group and region as fixed effects.|ANCOVA|||Week 104||-0.05|-1.16|0.0342
72607243|NCT00810199|144742314|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.04||||0.7095|TWO_SIDED|95.0|-0.23|0.16||Baseline x-ray and DAS28 as covariates and treatment group and region as fixed effects.|ANCOVA|||Week 24||0.16|-0.23|0.7095
72607244|NCT00810199|144742314|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.06||||0.8147|TWO_SIDED|95.0|-0.45|0.57||Baseline x-ray and DAS28 as covariates and treatment group and region as fixed effects.|ANCOVA|||Week 52||0.57|-0.45|0.8147
72607245|NCT00810199|144742314|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.32||||0.0778|TWO_SIDED|95.0|-0.67|0.04||Baseline x-ray and DAS28 as covariates and treatment group and region as fixed effects.|ANCOVA|||Week 104||0.04|-0.67|0.0778
72607246|NCT00810199|144742315|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.13||||0.0441|TWO_SIDED|95.0|-0.25|0.0||Baseline x-ray and DAS28 as covariates and treatment group and region as fixed effects.|ANCOVA|||Week 24||-0.00|-0.25|0.0441
72607247|NCT00810199|144742315|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.33||||0.0012|TWO_SIDED|95.0|-0.54|-0.13||Baseline x-ray and DAS28 as covariates and treatment group and region as fixed effects.|ANCOVA|||Week 52||-0.13|-0.54|0.0012
72607248|NCT00810199|144742315|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.29||||0.0372|TWO_SIDED|95.0|-0.56|-0.02||Baseline x-ray and DAS28 as covariates and treatment group and region as fixed effects.|ANCOVA|||Week 104||-0.02|-0.56|0.0372
72607249|NCT00810199|144742316|SUPERIORITY_OR_OTHER||Difference|6.75||||0.0694|TWO_SIDED|95.0|-1.02|14.52|||Cochran-Mantel-Haenszel|Stratified by region and categorical baseline DAS28 (≤ 5.5 and \> 5.5).||Week 52||14.52|-1.02|0.0694
72607250|NCT00810199|144742316|SUPERIORITY_OR_OTHER|||||||0.1695|TWO_SIDED||||||Log Rank|||Week 104||||0.1695
72607251|NCT00810199|144742317|SUPERIORITY_OR_OTHER||Difference|-2.91||||0.0496||95.0|-5.86|0.05|||Cochran-Mantel-Haenszel|Stratified by region and categorical baseline DAS28 (≤ 5.5 and \> 5.5).||||0.05|-5.86|0.0496
72607252|NCT00810199|144742318|SUPERIORITY_OR_OTHER||Difference|-1.48||||0.5188|TWO_SIDED|95.0|-6.59|3.62|||Cochran-Mantel-Haenszel|Stratified by region and categorical baseline DAS28 (≤ 5.5 and \> 5.5).||||3.62|-6.59|0.5188
72607253|NCT00810199|144742319|SUPERIORITY_OR_OTHER|||||||0.2652|||||||Wilcoxon (Mann-Whitney)|||Week 24||||0.2652
72607254|NCT00810199|144742319|SUPERIORITY_OR_OTHER|||||||0.197|||||||Wilcoxon (Mann-Whitney)|||Week 52||||0.1970
72607255|NCT00810199|144742319|SUPERIORITY_OR_OTHER|||||||0.1671|||||||Wilcoxon (Mann-Whitney)|||||||0.1671
72607256|NCT00810199|144742321|SUPERIORITY_OR_OTHER||Adjusted Mean Difference (Wald CI)|5.22||||0.111|TWO_SIDED|95.0|-1.2|11.64|||ANCOVA|The analysis of covariance model included treatment group, region and baseline DAS28 (≤ 5.5 and \> 5.5) as fixed factors.||||11.64|-1.20|0.1110
72607257|NCT00810199|144742322|SUPERIORITY_OR_OTHER||Adjusted Mean Difference (Wald CI)|-2.11||||0.6027|TWO_SIDED|95.0|-10.07|5.85|||ANCOVA|The analysis of covariance model included treatment group, region and baseline DAS28 (≤ 5.5 and \> 5.5) as fixed factors.||||5.85|-10.07|0.6027
72325143|NCT00279214|144173574|SUPERIORITY_OR_OTHER|||||||0.871||95.0||||24-Hour Change from Baseline p-value|Repeated Measures - propensity adjusted|||||||0.871
72325144|NCT00279214|144173575|SUPERIORITY_OR_OTHER|||||||0.704||95.0||||24-Hour p-value|Repeated Measures - propensity adjusted|||||||0.704
72325145|NCT00279214|144173575|SUPERIORITY_OR_OTHER|||||||0.702||95.0||||24-Hour Change from Baseline p-value|Repeated Measures - propensity adjusted|||||||0.702
72325146|NCT00279214|144173576|SUPERIORITY_OR_OTHER|||||||0.061||95.0||||6-Hour p-value|Repeated Measures - propensity adjusted|||||||0.061
72325147|NCT00279214|144173576|SUPERIORITY_OR_OTHER|||||||0.027||95.0||||6-Hour Change from Baseline p-value|Repeated Measures - propensity adjusted|||||||0.027
72325148|NCT00279214|144173577|SUPERIORITY_OR_OTHER|||||||0.242||95.0||||Baseline p-value|Repeated Measures - propensity adjusted|||||||0.242
72607258|NCT00810199|144742323|SUPERIORITY_OR_OTHER|||||||0.1695|||||||Log Rank|||||||0.1695
72607259|NCT00810199|144742324|SUPERIORITY_OR_OTHER|||||||0.0096|||||||Log Rank|||||||0.0096
72607260|NCT00810199|144742325|SUPERIORITY_OR_OTHER|||||||0.0734|||||||Log Rank|||||||0.0734
72607261|NCT01091246|144742327|NON_INFERIORITY_OR_EQUIVALENCE|The noninferior immune response was assessed by evaluating the upper bound of the two-sided 95% confidence intervals for the strain specific HAI antibody GMT ratios (FluMist divided by Q/LAIV) to the noninferiority margin of 1.5.|Ratio of geometric mean|1.07|||||TWO_SIDED|95.0|0.98|1.16|||Bootstrapping|||A/H1N1: The statistical hypothesis testing for the primary endpoint for Q/LAIV was: H0: Rj \> 1.5, for any j HA: Rj ≤ 1.5, for all j Where Rj was any of the 4 strain-specific post immunogenicity dose GMT ratios: (FluMist/B/Yamagata + FluMist/B/Victoria) / (Q/LAIV) for A/H1N1 strain||1.16|0.98|
72607262|NCT01091246|144742327|NON_INFERIORITY_OR_EQUIVALENCE|The noninferior immune response was assessed by evaluating the upper bound of the two-sided 95% confidence intervals for the strain specific HAI antibody GMT ratios (FluMist divided by Q/LAIV) to the noninferiority margin of 1.5. If the upper bounds of 95% CIs were ≤ 1.5 for all 4 strains, the immunologic noninferiority of Q/LAIV compared to FluMist was declared.|Ratio of geometric means|1.04|||||TWO_SIDED|95.0|0.94|1.14|||Bootstrapping|||A/H3N2: The statistical hypothesis testing for the primary endpoint for Q/LAIV was: H0: Rj \> 1.5, for any j HA: Rj ≤ 1.5, for all j Where Rj was any of the 4 strain-specific post immunogenicity dose GMT ratios: (FluMist/B/Yamagata + FluMist/B/Victoria) / (Q/LAIV) for A/H3N2 strain||1.14|0.94|
72607263|NCT01091246|144742327|NON_INFERIORITY_OR_EQUIVALENCE|The noninferior immune response was assessed by evaluating the upper bound of the two-sided 95% confidence intervals for the strain specific HAI antibody GMT ratios (FluMist divided by Q/LAIV) to the noninferiority margin of 1.5. If the upper bounds of 95% CIs were ≤ 1.5 for all 4 strains, the immunologic noninferiority of Q/LAIV compared to FluMist was declared.|Ratio of geometric mean|1.21|||||TWO_SIDED|95.0|1.07|1.37||||||B/Yamagata: The statistical hypothesis testing for the primary endpoint for Q/LAIV was: H0: Rj \> 1.5, for any j HA: Rj ≤ 1.5, for all j Where Rj was any of the 4 strain-specific post immunogenicity dose GMT ratios: (FluMist/B/Yamagata) / (Q/LAIV) for B/Yamagata strain||1.37|1.07|
72607264|NCT01091246|144742327|NON_INFERIORITY_OR_EQUIVALENCE|The noninferior immune response was assessed by evaluating the upper bound of the two-sided 95% confidence intervals for the strain specific HAI antibody GMT ratios (FluMist divided by Q/LAIV) to the noninferiority margin of 1.5. If the upper bounds of 95% confidence intervals were ≤ 1.5 for all 4 strains, the immunologic noninferiority of Q/LAIV compared to FluMist was declared.|Ratio of geometric mean|1.05|||||TWO_SIDED|95.0|0.93|1.18||||||B/Victoria: The statistical hypothesis testing for the primary endpoint for Q/LAIV was: H0: Rj \> 1.5, for any j HA: Rj ≤ 1.5, for all j Where Rj was any of the 4 strain-specific post immunogenicity dose GMT ratios: (FluMist/B/Victoria) / (Q/LAIV) for B/Victoria strain||1.18|0.93|
72607265|NCT02713178|144742363|SUPERIORITY||LSMD|-20.249||||0.4463|TWO_SIDED|95.0|-72.361|31.864|||ANOVA|||||31.864|-72.361|0.4463
72607266|NCT02713178|144742363|SUPERIORITY||LSMD|-28.796||||0.2749|TWO_SIDED|95.0|-80.483|22.892|||ANOVA|||||22.892|-80.483|0.2749
72607267|NCT02713178|144742364|SUPERIORITY||LSM treatment ratio|0.853||||0.0716|TWO_SIDED|95.0|0.717|1.014|||ANOVA|||||1.014|0.717|0.0716
72607268|NCT02713178|144742364|SUPERIORITY||LSM treatment ratio|0.913||||0.3004|TWO_SIDED|95.0|0.769|1.084|||ANOVA|||||1.084|0.769|0.3004
72607269|NCT02713178|144742366|SUPERIORITY|||||||0.1896|||||||Log Rank|||The overall distribution as estimated by the Kaplan-Meier analysis was compared between the EXPAREL arm and the placebo arm.||||0.1896
72607270|NCT02713178|144742366|SUPERIORITY|||||||0.2549|||||||Log Rank|||The overall distribution as estimated by the Kaplan-Meier analysis was compared between the EXPAREL arm and the placebo arm.||||0.2549
72607271|NCT02175225|144742468|OTHER|The alternative hypothesis, reflecting futility, is that the absolute treatment effect is less than 12% in favor of deferoxamine. In accordance with the futility design, futility was evaluated via the one-sided 90% upper confidence bound (90% UCB) of the treatment effect (absolute adjusted risk difference \[AARD\]); if the upper bound on the risk difference was less than 12% in favour of deferoxamine mesylate, this would be considered evidence of futility.|Risk Difference (RD)|0.006|||||ONE_SIDED|90.0||0.068|||||Futility was evaluated via the one-sided 90% upper confidence bound (90% UCB) of the treatment effect (absolute adjusted risk difference \[AARD\]); if UCB was less than 12% in favour of deferoxamine mesylate, this is considered evidence of futility.|||0.068||
72607272|NCT02175225|144742469|OTHER||Risk Ratio (RR)|0.81|||||TWO_SIDED|95.0|0.57|1.16||||||||1.16|0.57|
72607273|NCT02175225|144742470|OTHER||Risk Ratio (RR)|0.94|||||TWO_SIDED|95.0|0.57|1.56||||||||1.56|0.57|
72607274|NCT02175225|144742471|OTHER|The alternative hypothesis, reflecting futility, is that the absolute treatment effect is less than 13% in favor of deferoxamine. In accordance with the futility design, futility was evaluated via the one-sided 90% upper confidence bound (90% UCB) of the treatment effect (absolute adjusted risk difference \[AARD\]); if the upper bound on the risk difference was less than13% in favor of deferoxamine mesylate, this would be considered evidence of futility.|Risk Difference (RD)|0.062|||||ONE_SIDED|90.0||0.121|||||Futility was evaluated via the one-sided 90% upper confidence bound (90% UCB) of the treatment effect (absolute adjusted risk difference\[AARD\]); if UCB was less than 12% in favour of deferoxamine mesylate, this is considered evidence of futility.|||0.121||
72325149|NCT00279214|144173577|SUPERIORITY_OR_OTHER|||||||0.083||95.0||||12-Hour p-value|Repeated Measures - propensity adjusted|||||||0.083
72325150|NCT00279214|144173577|SUPERIORITY_OR_OTHER|||||||0.81||95.0||||24-Hour p-value|Repeated Measures - propensity adjusted|||||||0.810
72325151|NCT00279214|144173577|SUPERIORITY_OR_OTHER|||||||0.623||95.0||||24-Hour Change from Baseline p-value|Repeated Measures - propensity adjusted|||||||0.623
72325152|NCT00279214|144173578|SUPERIORITY_OR_OTHER|||||||0.686||95.0||||Baseline p-value|Repeated Measures - propensity adjusted|||||||0.686
72325153|NCT00279214|144173578|SUPERIORITY_OR_OTHER|||||||0.575||95.0||||24-Hour p-value|Repeated Measures - propensity adjusted|||||||0.575
72325154|NCT00279214|144173579|SUPERIORITY_OR_OTHER|||||||0.165||95.0|||||Repeated Measures - propensity adjusted|||||||0.165
72325155|NCT00279214|144173581|SUPERIORITY_OR_OTHER|||||||0.552||95.0||||Baseline p-value|Repeated Measures - propensity adjusted|||||||0.552
72607275|NCT02175225|144742472|OTHER|The alternative hypothesis, reflecting futility, is that the absolute treatment effect is less than 12% in favor of deferoxamine. In accordance with the futility design, futility was evaluated via the one-sided 90% upper confidence bound (90% UCB) of the treatment effect (absolute adjusted risk difference \[AARD\]); if the upper bound on the risk difference was less than 12% in favour of deferoxamine mesylate, this would be considered evidence of futility.|Risk Difference (RD)|0.086|||||ONE_SIDED|90.0||0.156|||||Futility was evaluated via the one-sided 90% upper confidence bound (90% UCB) of the treatment effect (absolute adjusted risk difference \[AARD\]); if UCB was less than 12% in favour of deferoxamine mesylate, this is considered evidence of futility.|||0.156||
72607276|NCT02175225|144742473|OTHER|The alternative hypothesis, reflecting futility, is that the absolute treatment effect is less than 13% in favor of deferoxamine. In accordance with the futility design, futility was evaluated via the one-sided 90% upper confidence bound (90% UCB) of the treatment effect (absolute adjusted risk difference \[AARD\]); if the upper bound on the risk difference was less than 13% in favour of deferoxamine mesylate, this would be considered evidence of futility.|Risk Difference (RD)|-0.018|||||ONE_SIDED|90.0||0.029|||||Futility was evaluated via the one-sided 90% upper confidence bound (90% UCB) of the treatment effect (absolute adjusted risk difference \[AARD\]); if UCB was less than 13% in favour of deferoxamine mesylate, this is considered evidence of futility.|||0.029||
72607277|NCT02175225|144742474|OTHER|||||||0.83||||||The p value reflects the significance of the interaction term between treatment and onset to treatment time.|Regression, Logistic|||||||0.83
72607278|NCT02175225|144742475|OTHER||Odds Ratio (OR)|1.1|||||TWO_SIDED|95.0|0.72|1.67|||||The estimation parameter is the adjusted common odds ratio.|||1.67|0.72|
72325156|NCT00279214|144173581|SUPERIORITY_OR_OTHER|||||||0.129||95.0||||12-Hour p-value|Repeated Measures - propensity adjusted|||||||0.129
72325157|NCT00279214|144173581|SUPERIORITY_OR_OTHER|||||||0.03||95.0||||24-Hour p-value|Repeated Measures - propensity adjusted|||||||0.030
72325158|NCT00279214|144173581|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||24-Hour Change from Baseline p-value|Repeated Measures - propensity adjusted|||||||0.002
72325159|NCT00279214|144173583|SUPERIORITY_OR_OTHER|||||||0.128||95.0||||24-Hour p-value|Repeated Measures - propensity adjusted|||||||0.128
72325160|NCT00279214|144173583|SUPERIORITY_OR_OTHER|||||||0.234||95.0||||24-Hour Change from Baseline p-value|Repeated Measures - propensity adjusted|||||||0.234
72325161|NCT01214837|144173585|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI for the difference in percentage of subjects with hSBA titers ≥ 1:8 against N. meningitidis serogroups C, W and Y between the 3-dose series and (minus) the 4-dose series, is greater than -10%.|Vaccine group difference|-7.0|||||TWO_SIDED|95.0|-14.0|-1.0|||Miettinen and Nurminen method|||Non-inferiority of Men ACWY 3-dose series (doses at 2, 4 and 12 months) to 4-dose series (doses at 2, 4, 6 and 12 months of age) against serogroup A at 13 months of age.||-1|-14|
72325162|NCT01214837|144173585|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI for the difference in percentage of subjects with hSBA titers ≥ 1:8 against N. meningitidis serogroups C, W and Y between the 3-dose series and (minus) the 4-dose series, is greater than -10%.|Vaccine group difference|-4.0|||||TWO_SIDED|95.0|-8.0|0.0|||Miettinen and Nurminen method|||Non-inferiority of Men ACWY 3-dose series (doses at 2, 4 and 12 months) to 4-dose series (doses at 2, 4, 6 and 12 months of age) against serogroup C at 13 months of age.||0|-8|
72325163|NCT01214837|144173585|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI for the difference in percentage of subjects with hSBA titers ≥ 1:8 against N. meningitidis serogroups C, W and Y between the 3-dose series and (minus) the 4-dose series, is greater than -10%.|Vaccine group difference|0.0|||||TWO_SIDED|95.0|-3.0|3.0|||Miettinen and Nurminen method|||Non-inferiority of Men ACWY 3-dose series (doses at 2, 4 and 12 months) to 4-dose series (doses at 2, 4, 6 and 12 months of age) against serogroup W at 13 months of age.||3|-3|
72325164|NCT01214837|144173585|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI for the difference in percentage of subjects with hSBA titers ≥ 1:8 against N. meningitidis serogroups C, W and Y between the 3-dose series and (minus) the 4-dose series, is greater than -10%.|Vaccine group difference|1.0|||||TWO_SIDED|95.0|-2.0|4.0|||Miettinen and Nurminen method|||Non-inferiority of Men ACWY 3-dose series (doses at 2, 4 and 12 months) to 4-dose series (doses at 2, 4, 6 and 12 months of age) against serogroup Y at 13 months of age.||4|-2|
72325165|NCT01214837|144173592|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI for the between group difference (MenACWY3 minus Routine) in percentage of subjects with IgG concentration ≥ 0.35 μg/mL against each pneumococcal anti-capsular polysaccharide is greater than -10%.|Vaccine group difference|-0.5|||||TWO_SIDED|95.0|-6.1|5.0|||Miettinen and Nurminen method|||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 2 doses of MenACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 7 months of age for Serotype 1.||5|-6.1|
72325166|NCT01214837|144173592|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI for the between group difference (MenACWY4 minus Routine) in percentage of subjects with IgG concentration ≥ 0.35 μg/mL against each pneumococcal anti-capsular polysaccharide is greater than -10%.|Vaccine group difference|5.8|||||TWO_SIDED|95.0|3.0|10.5|||Miettinen and Nurminen method|||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 3 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 7 months of age for Serotype 1.||10.5|3|
72607279|NCT02175225|144742476|OTHER||Odds Ratio, log|1.26|||||TWO_SIDED|95.0|0.82|1.93||||||||1.93|0.82|
72607280|NCT02175225|144742479|OTHER||Risk Ratio (RR)|0.77|||||TWO_SIDED|95.0|0.0|14.97|||||Confidence interval is exact (rather than asymptotic) due to small number of events.|||14.97|0.0|
72607281|NCT02175225|144742480|OTHER||Risk Ratio (RR)|0.89|||||TWO_SIDED|95.0|0.51|1.54|||||Confidence interval constructed only for all cause owing to small number of events caused by acute respiratory distress syndrome.|||1.54|0.51|
72607282|NCT02175225|144742481|OTHER||Risk Ratio (RR)|1.84|||||TWO_SIDED|95.0|0.63|5.35||||||||5.35|0.63|
72607283|NCT00078286|144742482|NON_INFERIORITY_OR_EQUIVALENCE|\*Power analysis already provided.|Difference in mean change score|-0.3||||0.89||95.0|||||Mixed Models Analysis|Significance was tested at p=.05.||A hierarchical mixed model was used, analyzing the fixed effects of treatment, the natural log of time, natural log of time squared, the interactions of time and time squared with treatment and site, as well as the random effects of patient, patient-by-time, and square of patient-by-time.||||0.89
72607284|NCT00078286|144742483|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.08||||0.78||95.0|||||Cochran-Mantel-Haenszel|||Tests for differences of proportions were used to examine the composite cardiovascular status outcome at the end of acute treatment. Chi-square tests were used to test for overall treatment differences, with a Mantel Haenszel test performed to examine treatment differences when controlling for clinical site. The primary analyses were conducted on the tri-level cardiovascular status outcome.||||.78
72607285|NCT01409239|144742496|SUPERIORITY_OR_OTHER|||||||0.05||||||Wilcoxon rank-sum was used to determine differences between groups.|Wilcoxon (Mann-Whitney)|||Since this was a pilot study no formal power analysis was possible. It was hypothesized that IV insulin would be associated with lower LF/HF HRV.||||0.05
72607286|NCT01121263|144742500|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.063||||0.8||95.0|0.666|1.697|||Regression, Cox|The Cox proportional hazards regression model was weighted by propensity score to adjust for differences in baseline risk between the two groups.|The Cox model was weighted by propensity score to adjust for differences in baseline risk between the two groups.|This applies to any MACCE||1.697|0.666|0.80
72607287|NCT01121263|144742501|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.868||||0.53||95.0|0.556|1.355|||Regression, Cox||The Cox proportional hazards regression model was weighted by the propensity score to account for the difference in baseline risk between groups.|This applies to any MACCE||1.355|0.556|0.53
72607288|NCT01386606|144742522|SUPERIORITY_OR_OTHER|||||||0.056|TWO_SIDED|||||P-value of treatment group.|Regression, Linear|||"Regression of 24 Hours Average Total Testosterone, Treatment Group and Morning Testosterone at Week 6.~Modeling 24 hour average total testosterone by morning testosterone and treatment group."||||0.056
72607289|NCT01386606|144742522|SUPERIORITY_OR_OTHER||Regression Coefficient|-45.77||||0.436|TWO_SIDED|95.0|-143.5|51.98||P-value for Androxal 25 mg treatment group.|Regression, Linear|||"Regression of 24 Hours Average Total Testosterone, Treatment Group and Morning Testosterone at Week 6.~Modeling 24 hour average total testosterone by morning testosterone and treatment group."||51.98|-143.5|0.436
72607290|NCT01386606|144742522|SUPERIORITY_OR_OTHER||Regression Coefficient|-110.9||||0.068|TWO_SIDED|95.0|-210.6|-11.23||P-value for Androxal 12.5 mg group.|Regression, Linear|||"Regression of 24 Hours Average Total Testosterone, Treatment Group and Morning Testosterone at Week 6.~Modeling 24 hour average total testosterone by morning testosterone and treatment group."||-11.23|-210.6|0.068
72607291|NCT01386606|144742522|SUPERIORITY_OR_OTHER||Regression Coefficient|-148.5||||0.011|TWO_SIDED|95.0|-242.9|-54.05||P-value for Androxal 6.25 mg group.|Regression, Linear|||"Regression of 24 Hours Average Total Testosterone, Treatment Group and Morning Testosterone at Week 6.~Modeling 24 hour average total testosterone by morning testosterone and treatment group."||-54.05|-242.9|0.011
72607292|NCT01386606|144742522|SUPERIORITY_OR_OTHER||Regression Coefficient|0.58|||<|0.001|TWO_SIDED|95.0|0.37|0.79||P-value for morning total testosterone (adjusted for treatment effect if treatment group is significant).|Regression, Linear|||"Regression of 24 Hours Average Total Testosterone, Treatment Group and Morning Testosterone at Week 6.~Modeling 24 hour average total testosterone by morning testosterone and treatment group."||0.79|0.37|<0.001
72607293|NCT01386606|144742523|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||P-value for treatment group effect.|ANOVA|||ANOVA results - change from baseline in morning LH at Week 2. Modeling change from baseline by treatment group.||||<0.001
72607294|NCT01386606|144742523|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||P-value for treatment group effect.|ANOVA|||ANOVA results - change from baseline in morning LH at Week 4. Modeling change from baseline by treatment group.||||<0.001
72607295|NCT01386606|144742523|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||P-value for treatment group effect.|ANOVA|||ANOVA results - change from baseline in morning LH at Week 6. Modeling change from baseline by treatment group.||||<0.001
72607296|NCT01386606|144742524|SUPERIORITY_OR_OTHER||Pearson Correlation|0.90993|||<|0.0001|TWO_SIDED||||||t-test, 2 sided|||Pearson correlation between 9 am morning testosterone and serial testosterone Cavg at Week 6.||||<0.0001
72607297|NCT01386606|144742524|SUPERIORITY_OR_OTHER||Pearson Correlation|0.86541|||<|0.0001|TWO_SIDED||||||t-test, 2 sided|||Pearson correlation between 9 am morning testosterone and serial testosterone Cmin at Week 6.||||<0.0001
72607298|NCT01386606|144742524|SUPERIORITY_OR_OTHER||Pearson Correlation|0.89643|||<|0.0001|TWO_SIDED||||||t-test, 2 sided|||Pearson correlation between 9 am morning testosterone and serial testosterone Cmax at Week 6.||||<0.0001
72607299|NCT01386606|144742526|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||P-value for treatment group effect.|ANOVA|||ANOVA results - change from baseline in morning FSH at Week 2. Modeling change from baseline by treatment group.||||<0.001
72607300|NCT01386606|144742526|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||P-value for treatment group effect.|ANOVA|||ANOVA results - change from baseline in morning FSH at Week 4. Modeling change from baseline by treatment group.||||<0.001
72607301|NCT01386606|144742526|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||P-value for treatment group effect.|ANOVA|||ANOVA results - change from baseline in morning FSH at Week 6. Modeling change from baseline by treatment group.||||<0.001
72607302|NCT01022203|144742531|SUPERIORITY_OR_OTHER||Slope|0.0001|||<|0.0001|TWO_SIDED||||||Mixed Models Analysis|||Used Intent to Treat Analysis. General linear mixed models (GLMMs) with main effects of treatment (SAT and PFE), time (baseline, end of treatment, and 12 week follow-up), and treatment by time interactions to model the longitudinal trajectories of the outcomes, for veterans and their partners. Time was flexibly modeled. All available observations from each subject were utilized in the GLMM modeling.||||<0.0001
72607303|NCT01022203|144742532|SUPERIORITY_OR_OTHER||Slope|0.004|||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||Used Intent to Treat Analysis. General linear mixed models (GLMMs) with main effects of treatment (SAT and PFE), time (baseline, end of treatment, and 12 week follow-up), and treatment by time interactions to model the longitudinal trajectories of the outcomes for veterans. Time was flexibly modeled. All available observations from each subject were utilized in the GLMM modeling.||||<0.001
72607304|NCT01022203|144742533|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Mixed Models Analysis|||General linear mixed models with main effects of treatment, time (baseline, end of treatment, and 12 week follow-up), and treatment by time interactions as described for previous analyses.||||<0.0001
72607305|NCT04152200|144742557|OTHER|Not applied|Least Squares (LS) Mean|-33.33|STANDARD_ERROR_OF_MEAN|17.63|||TWO_SIDED|95.0|-81.82|15.16|||Mixed model repeated measures (MMRM)|||Restricted maximum likelihood (REML) based Mixed Model Repeated Measures (MMRM) was used to test against the null hypothesis of mean change from baseline outcome being equal to 0. The model includes scheduled visits and baseline plasma oxalate (μmol/L) as fixed effects and patient as a random factor. Autoregressive (1) was used to model the within-patient variability.||15.16|-81.82|
72607306|NCT04152200|144742558|OTHER|Not applied|Least Squares (LS) Mean|-42.43|STANDARD_ERROR_OF_MEAN|3.95|||TWO_SIDED|95.0|-50.71|-34.15|||MMRM|||REML based Mixed Model Repeated Measures MMRM was used to test against the null hypothesis of mean change from baseline outcome being equal to 0. The model includes scheduled visits and baseline plasma oxalate (μmol/L) as fixed effects and patient as a random factor. Autoregressive (1) was used to model the within-patient variability.||-34.15|-50.71|
72607307|NCT00593814|144742605|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||||||<0.001
72607308|NCT02699996|144742610|SUPERIORITY||Mean Difference (Final Values)|0.52|||<|0.01|TWO_SIDED|95.0|0.17|0.86|||t-test, 2 sided|df = 14||RTQ-Survivor Adolescent Responsibility Score||0.86|0.17|<.01
72607309|NCT02699996|144742610|SUPERIORITY||Mean Difference (Final Values)|0.67|||<|0.01|TWO_SIDED|95.0|0.27|1.07|||t-test, 2 sided|df=14||RTQ-Overall Readiness Score||1.07|0.27|<.01
72607310|NCT02699996|144742611|SUPERIORITY||Mean Difference (Final Values)|0.23||||0.02|TWO_SIDED|95.0|0.05|0.42|||t-test, 2 sided|df=14||TRI-total Score||0.42|0.05|0.02
72607311|NCT02699996|144742611|SUPERIORITY||Mean Difference (Final Values)|0.49|||<|0.01|TWO_SIDED|95.0|0.26|0.73|||t-test, 2 sided|df=14||TRI Knowledge score||0.73|0.26|<.01
72607312|NCT02699996|144742611|SUPERIORITY||Mean Difference (Final Values)|0.3||||0.053|TWO_SIDED|95.0|-0.0044|0.6|||t-test, 2 sided|df=14||TRI Skills/Self-Efficacy Score||0.60|-0.0044|0.053
72607313|NCT02699996|144742611|SUPERIORITY||Mean Difference (Final Values)|0.13||||0.03|TWO_SIDED|95.0|0.02|0.24|||t-test, 2 sided|df=14||TRI Beliefs/Expectations score||0.24|0.02|0.03
72607314|NCT02699996|144742611|SUPERIORITY||Mean Difference (Final Values)|0.4|||<|0.01|TWO_SIDED|95.0|0.11|0.69|||t-test, 2 sided|df=14||TRI Goals/Motivation score||0.69|0.11|<.01
72607315|NCT02699996|144742611|SUPERIORITY||Mean Difference (Final Values)|0.05||||0.61|TWO_SIDED|95.0|-0.16|0.26|||t-test, 2 sided|df=14||Relationship/Communication Score||0.26|-0.16|0.61
72607316|NCT02699996|144742611|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.65|TWO_SIDED|95.0|-0.37|0.57|||t-test, 2 sided|df=14||TRI Psychosocial/Emotional Score||0.57|-0.37|0.65
72607317|NCT02699996|144742612|SUPERIORITY||Median Difference (Final Values)|-1.64||||0.56|TWO_SIDED|95.0|-7.62|4.34|||t-test, 2 sided|df = 13||||4.34|-7.62|.56
72607318|NCT02699996|144742613|SUPERIORITY||Mean Difference (Final Values)|-1.74||||0.42|TWO_SIDED|95.0|-6.23|2.75|||t-test, 2 sided|df = 14||||2.75|-6.23|.42
72607319|NCT02699996|144742614|SUPERIORITY||Mean Difference (Final Values)|-0.28||||0.26|TWO_SIDED|95.0|-0.8|0.23|||t-test, 2 sided|df = 14||||0.23|-0.80|.26
72607320|NCT02699996|144742615|SUPERIORITY||Mean Difference (Final Values)|0.28||||0.03|TWO_SIDED|95.0|0.03|0.52|||t-test, 2 sided|df = 14||||0.52|0.03|.03
72607321|NCT02699996|144742616|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.2|TWO_SIDED|95.0|-0.12|0.52|||t-test, 2 sided|df = 14||Body Health Subscale||0.52|-0.12|.20
72607322|NCT02699996|144742616|SUPERIORITY||Mean Difference (Final Values)|-0.13||||0.4|TWO_SIDED|95.0|-0.46|0.2|||t-test, 2 sided|df = 14||Personal Growth Subscale||0.20|-0.46|.40
72607323|NCT02699996|144742616|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.29|TWO_SIDED|95.0|-0.09|0.29|||t-test, 2 sided|df = 14||Memory Subscale||0.29|-0.09|.29
72607324|NCT02699996|144742617|SUPERIORITY||Mean Difference (Final Values)|-0.19||||0.08|TWO_SIDED|95.0|-0.4|0.03|||t-test, 2 sided|df = 14||||0.03|-0.40|.08
72607325|NCT01095835|144742632|SUPERIORITY_OR_OTHER|||||||0.08|||||||Chi-squared|||||||0.08
72607326|NCT00729521|144742675|SUPERIORITY_OR_OTHER||Incidence Rate Ratio|0.92|STANDARD_DEVIATION|1.0|<|0.05|TWO_SIDED|95.0|0.88|0.95|||Mixed Models Analysis|Mixed Effects Poisson Regression|Comparison group is the control arm.|||0.95|0.88|<0.05
72607327|NCT00729521|144742675|SUPERIORITY_OR_OTHER||Incident Rate Ratio|0.91|STANDARD_DEVIATION|1.0|<|0.05|TWO_SIDED|95.0|0.88|0.94|||Mixed Models Analysis|Mixed Effected Poisson Model Regression|Comparison group is the control arm.|||0.94|0.88|<.05
72416818|NCT04435366|144344312|SUPERIORITY||Least Squares Mean Difference|-1.49|STANDARD_ERROR_OF_MEAN|1.68||0.38|TWO_SIDED|95.0|-4.79|1.81||Nominal p-value was used for the comparison between avacincaptad pegol versus sham.|MMRM|||Difference in least squares mean between groups calculated as (sham) minus (avacincaptad pegol).||1.81|-4.79|0.38
72416819|NCT04435366|144344314|SUPERIORITY||Least square mean difference|-0.712|STANDARD_ERROR_OF_MEAN|1.33||0.5929|TWO_SIDED|95.0|-3.326|1.903|||MMRM|||||1.903|-3.326|0.5929
72416820|NCT04435366|144344316|SUPERIORITY||Hazard Ratio (HR)|0.9||||0.6424|TWO_SIDED|95.0|0.57|1.42|||Log Rank|||||1.42|0.57|0.6424
72607328|NCT03652818|144742683|SUPERIORITY||Least Square (LS) Mean Difference|-25.2868|STANDARD_ERROR_OF_MEAN|16.1594|||ONE_SIDED|90.0||-4.421|||||Statistics are from ANCOVA including treatment and sex as fixed effects with baseline PI score prior to Dose 2 as a covariate. The lower limit of one-sided 90% CI was -∞|Group D vs. Group B||-4.4210||
72607329|NCT03652818|144742683|SUPERIORITY||LS Mean Difference|-0.2756|STANDARD_ERROR_OF_MEAN|16.3283|||ONE_SIDED|90.0||20.8083|||||Statistics are from ANCOVA including treatment and sex as fixed effects with baseline PI score prior to Dose 2 as a covariate. The lower limit of one-sided 90% CI was -∞|Group C vs. Group B||20.8083||
72607330|NCT03652818|144742683|SUPERIORITY||LS Mean Difference|-65.9241|STANDARD_ERROR_OF_MEAN|17.2146|||ONE_SIDED|90.0||-43.6959|||||Statistics are from ANCOVA including treatment and sex as fixed effects with baseline PI score prior to Dose 2 as a covariate. The lower limit of one-sided 90% CI was -∞|Group C vs. Group A||-43.6959||
72607331|NCT03652818|144742683|SUPERIORITY||LS Mean Difference|-65.6486|STANDARD_ERROR_OF_MEAN|16.8753|||ONE_SIDED|90.0||-43.8584|||||Statistics are from ANCOVA including treatment and sex as fixed effects with baseline PI score prior to Dose 2 as a covariate. The lower limit of one-sided 90% CI was -∞|Group B vs. Group A||-43.8584||
72607332|NCT03652818|144742683|SUPERIORITY||LS Mean Difference|-90.9353|STANDARD_ERROR_OF_MEAN|17.1044|||ONE_SIDED|90.0||-68.8494|||||Statistics are from ANCOVA including treatment and sex as fixed effects with baseline PI score prior to Dose 2 as a covariate. The lower limit of one-sided 90% CI was -∞|Group D vs. Group A||-68.8494||
72607333|NCT03652818|144742683|SUPERIORITY||LS Mean Difference|-25.0112|STANDARD_ERROR_OF_MEAN|16.5376|||ONE_SIDED|90.0||-3.6571|||||Statistics are from ANCOVA including treatment and sex as fixed effects with baseline PI score prior to Dose 2 as a covariate. The lower limit of one-sided 90% CI was -∞|Group D vs. Group C||-3.6571||
72607334|NCT03652818|144742683|SUPERIORITY||LS Mean Difference|10.9546|STANDARD_ERROR_OF_MEAN|21.0237|||ONE_SIDED|90.0||38.1014|||||Statistics are from ANCOVA including treatment and sex as fixed effects with baseline PI score prior to Dose 2 as a covariate. The lower limit of one-sided 90% CI was -∞|Group E vs. Group D||38.1014||
72607335|NCT03652818|144742684|SUPERIORITY||LS Mean Difference|33.6821|STANDARD_ERROR_OF_MEAN|20.1209|||ONE_SIDED|90.0|7.7011||||||Statistics are from ANCOVA including treatment and sex as fixed effects with baseline PI score prior to Dose 2 as a covariate. The upper limit was ∞|Group D vs. Group B|||7.7011|
72607336|NCT03652818|144742684|SUPERIORITY||LS Mean Difference|6.1658|STANDARD_ERROR_OF_MEAN|20.3312|||ONE_SIDED|90.0|-20.0868||||||Statistics are from ANCOVA including treatment and sex as fixed effects with baseline PI score prior to Dose 2 as a covariate. The upper limit was ∞|Group C vs. Group B|||-20.0868|
72416821|NCT03492281|144344342|SUPERIORITY||Least Squares Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.15|<|0.001|TWO_SIDED|95.0|-0.8|-0.2||Hypothesis testing was performed for vibegron minus placebo.|Mixed Model for Repeated Measures (MMRM)|||||-0.2|-0.8|<0.001
72416822|NCT03492281|144344342|SUPERIORITY||Least Squares Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.16|=|0.0988|TWO_SIDED|95.0|-0.6|0.1||Comparisons between tolterodine ER and placebo are considered descriptive.|MMRM|||||0.1|-0.6|=0.0988
72607337|NCT03652818|144742684|SUPERIORITY||LS Mean Difference|77.3395|STANDARD_ERROR_OF_MEAN|21.4347|||ONE_SIDED|90.0|49.662||||||Statistics are from ANCOVA including treatment and sex as fixed effects with baseline PI score prior to Dose 2 as a covariate. The upper limit was ∞|Group C vs. Group A|||49.6620|
72607338|NCT03652818|144742684|SUPERIORITY||LS Mean Difference|71.1737|STANDARD_ERROR_OF_MEAN|21.0123|||ONE_SIDED|90.0|44.0417||||||Statistics are from ANCOVA including treatment and sex as fixed effects with baseline PI score prior to Dose 2 as a covariate. The upper limit was ∞|Group B vs. Group A|||44.0417|
72607339|NCT03652818|144742684|SUPERIORITY||LS Mean Difference|104.8558|STANDARD_ERROR_OF_MEAN|21.2975|||ONE_SIDED|90.0|77.3555||||||Statistics are from ANCOVA including treatment and sex as fixed effects with baseline PI score prior to Dose 2 as a covariate. The upper limit was ∞|Group D vs. Group A|||77.3555|
72607340|NCT03652818|144742684|SUPERIORITY||LS Mean Difference|27.5163|STANDARD_ERROR_OF_MEAN|20.5918|||ONE_SIDED|90.0|0.9272||||||Statistics are from ANCOVA including treatment and sex as fixed effects with baseline PI score prior to Dose 2 as a covariate. The upper limit was ∞|Group D vs. Group C|||0.9272|
72416823|NCT03492281|144344343|SUPERIORITY||Least Squares Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-0.9|-0.3||Hypothesis testing was performed for vibegron minus placebo.|MMRM|||||-0.3|-0.9|<0.0001
72416824|NCT03492281|144344343|SUPERIORITY||Least Squares Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.15|=|0.0123|TWO_SIDED|95.0|-0.7|-0.1||Comparisons between tolterodine ER and placebo are considered descriptive.|MMRM|||||-0.1|-0.7|=0.0123
72416825|NCT03492281|144344344|SUPERIORITY||Least Squares Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.22|=|0.002|TWO_SIDED|95.0|-1.1|-0.2||Hypothesis testing was performed for vibegron minus placebo.|MMRM|||||-0.2|-1.1|=0.0020
72607341|NCT03652818|144742684|SUPERIORITY||LS Mean Difference|-30.1223|STANDARD_ERROR_OF_MEAN|26.1776|||ONE_SIDED|90.0|-63.924||||||Statistics are from ANCOVA including treatment and sex as fixed effects with baseline PI score prior to Dose 2 as a covariate. The upper limit was ∞|Group E vs. Group D|||-63.9240|
72416826|NCT03492281|144344344|SUPERIORITY||Least Squares Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.23|=|0.0648|TWO_SIDED|95.0|-0.9|0.0||Comparisons between tolterodine ER and placebo are considered descriptive.|MMRM|||||0.0|-0.9|=0.0648
72607342|NCT03964207|144742688|SUPERIORITY||Difference of LSmeans|-5.28||||0.007|TWO_SIDED|95.0|-9.07|-1.48|||Mixed-effects Model||The Least squares means (LSmeans) were adjusted with treatment and visit. And the Difference of LSmeans was calculated as: value from the test treatment group - value from the comparator treatment group.|The hypothesis test was held to investigate the superiority of the test treatment. Mixed-effects Model for Repeated Measures (MMRM) was used to analyze the performance domain of PASAPQ score, with treatment and period as fixed effects, and patient as a random effect.||-1.48|-9.07|0.007
72607343|NCT03964207|144742689|SUPERIORITY||Difference of LSmeans|-4.14||||0.024|TWO_SIDED|95.0|-7.72|-0.56|||Mixed Models Analysis||The Least squares means (LSmeans) were adjusted with treatment and visit. And the Difference of LSmeans was calculated as: value from the test treatment group - value from the comparator treatment group.|The hypothesis test was held to investigate the superiority of the test treatment. Mixed-effects Model for Repeated Measures (MMRM) was used to analyze the performance domain of PASAPQ score, with treatment and period as fixed effects, and patient as a random effect||-0.56|-7.72|0.024
72607344|NCT03964207|144742690|SUPERIORITY||Difference rate (%)|13.0||||0.249|||||||Chi-square test||The Difference rate was calculated as: value from the test treatment group - value from the comparator treatment group.|Chi-squared test was used to analyze proportion of patients indicating preference in the Patient satisfaction and preference questionnaire (PASAPQ) at week 8. All participants have used both treatments at this point: Handihaler (4 weeks) and Respimat (4 weeks).||||0.249
72607345|NCT03964207|144742691|SUPERIORITY||Difference of LSmeans|-4.72||||0.057|TWO_SIDED|95.0|-9.59|0.15|||The mixed model for repeated measures||The Least squares means (LSmeans) were adjusted with treatment and visit. And the Difference of LSmeans was calculated as: value from the test treatment group - value from the comparator treatment group.|The hypothesis test was held to investigate the superiority of the test treatment. Mixed-effects Model for Repeated Measures (MMRM) was used to analyze the performance domain of PASAPQ score, with treatment and period as fixed effects, and patient as a random effect.||0.15|-9.59|0.057
72607346|NCT03964207|144742692|SUPERIORITY||Difference of LSmeans|-4.38||||0.347|TWO_SIDED|95.0|-13.63|4.86|||Mixed Models Analysis||The Least squares means (LSmeans) were adjusted with treatment and visit. And the Difference of LSmeans was calculated as: value from the test treatment group - value from the comparator treatment group.|The hypothesis test was held to investigate the superiority of the test treatment. Mixed-effects Model for Repeated Measures (MMRM) was used to analyze the performance domain of PASAPQ score, with treatment and period as fixed effects, and patient as a random effect.||4.86|-13.63|0.347
72607347|NCT01811732|144742715|NON_INFERIORITY|A 2-sided 95% confidence interval (CI) for noninferiority testing was computed based on the difference in sample rates for vancomycin + aztreonam and delafloxacin at the primary endpoint. If the upper limit (UL) of the CI was less than 0.10, delafloxacin would be considered noninferior to vancomycin + aztreonam.|Difference in Responder Rates|-2.6|||||TWO_SIDED|95.0|-8.8|3.6||||||||3.6|-8.8|
72607348|NCT02452047|144742730|OTHER|Difference in percentages|Difference in FOR %|-7.3|||||TWO_SIDED|90.0|-27.5|21.4|||||Stratified Miettinen \& Nurminen method by infection type|||21.4|-27.5|
72607349|NCT02452047|144742731|OTHER|Difference in percentages|Difference in AE %|-10.3|||||TWO_SIDED|95.0|-33.1|18.0|||||Miettinen \& Nurminen method|||18.0|-33.1|
72607350|NCT02452047|144742732|OTHER|Difference in percentages|Difference in SAE %|-21.6|||||TWO_SIDED|95.0|-47.8|1.3|||||Miettinen \& Nurminen method|||1.3|-47.8|
72607351|NCT02452047|144742733|OTHER|Difference in percentages|Difference in drug-related AE %|-15.1|||||TWO_SIDED|95.0|-42.3|9.2|||||Miettinen \& Nurminen method|||9.2|-42.3|
72607352|NCT02452047|144742734|OTHER|Difference in percentages|Difference in drug-related SAE %|0.0|||||TWO_SIDED|95.0|-19.7|11.2|||||Miettinen \& Nurminen method|||11.2|-19.7|
72607353|NCT02452047|144742735|OTHER|Difference in percentages|Difference in discontinuation %|-18.8|||||TWO_SIDED|95.0|-43.3|-6.2|||||Miettinen \& Nurminen method|||-6.2|-43.3|
72607354|NCT02452047|144742736|OTHER|Difference in percentages|Difference in drug-related discon %|-12.5|||||TWO_SIDED|95.0|-36.3|-0.3|||||Miettinen \& Nurminen method|||-0.3|-36.3|
72607355|NCT02452047|144742737|OTHER|Difference in percentages|Difference in pyrexia %|0.4|||||TWO_SIDED|95.0|-25.2|19.7|||||Miettinen \& Nurminen method|||19.7|-25.2|
72607356|NCT02452047|144742737|OTHER|Difference in percentages|Difference blood creatinine inc %|-25.0|||||TWO_SIDED|95.0|-49.8|-10.1|||||Miettinen \& Nurminen method|||-10.1|-49.8|
72607357|NCT02452047|144742738|OTHER|Difference in Category 1 ECI %|Difference in Category 1 ECI %|-12.5||||0.047|TWO_SIDED|95.0|-36.3|-0.3|||Miettinen and Nurminen method|||||-0.3|-36.3|0.047
72416827|NCT03492281|144344345|SUPERIORITY||Difference in percentage|16.5|||<|0.0001|TWO_SIDED|95.0|9.7|23.4|||Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel risk difference estimate was stratified by sex (female/male), with weights proposed by Greenland and Robins.||||23.4|9.7|<0.0001
72607358|NCT02452047|144742738|OTHER|Difference in Category 2 ECI %|Difference in Category 2 ECI %|-12.5||||0.047||95.0|-36.3|-0.3|||Miettinen and Nurminen method|||||-0.3|-36.3|0.047
72607359|NCT02452047|144742739|OTHER|Difference in percentages|Difference in nephrotoxicity %|-45.9||||0.002||95.0|-69.1|-18.4|||Fisher Exact||Miettinen \& Nurminen method|||-18.4|-69.1|0.002
72607360|NCT02452047|144742740|OTHER|Difference in Day 28 FCR %|Difference in Day 28 FCR %|26.3|||||TWO_SIDED|90.0|1.3|51.5|||||Miettinen and Nurminen method stratified by infection-site stratum|||51.5|1.3|
72607361|NCT02452047|144742741|OTHER|Difference in mortality %|Difference in mortality %|-17.3|||||TWO_SIDED|90.0|-46.4|6.7|||||Miettinen and Nurminen method stratified by infection-site stratum|||6.7|-46.4|
72607362|NCT02452047|144742742|OTHER|Adjusted difference in OTX FCR %|Adjusted difference in OTX FCR %|33.9|||||TWO_SIDED|90.0|7.4|61.1|||||Miettinen and Nurminen method stratified by infection-site stratum|||61.1|7.4|
72607363|NCT02452047|144742743|OTHER|Adjusted difference in EOT FCR %|Adjusted difference in EOT FCR %|25.4|||||TWO_SIDED|90.0|3.1|53.6|||||Miettinen and Nurminen method stratified by infection-site stratum|||53.6|3.1|
72416828|NCT03492281|144344345|SUPERIORITY||Difference in percentage|9.4|||=|0.012|TWO_SIDED|95.0|2.1|16.7|||Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel risk difference estimate was stratified by sex (female/male), with weights proposed by Greenland and Robins.||||16.7|2.1|=0.0120
72416829|NCT03492281|144344346|SUPERIORITY||Difference in percentage|6.3|||=|0.036|TWO_SIDED|95.0|0.4|12.1|||Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel risk difference estimate was stratified by sex (female/male), with weights proposed by Greenland and Robins.||||12.1|0.4|=0.0360
72416830|NCT03492281|144344346|SUPERIORITY||Difference in percentage|1.9|||=|0.5447|TWO_SIDED|95.0|-4.1|7.8|||Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel risk difference estimate was stratified by sex (female/male), with weights proposed by Greenland and Robins.||||7.8|-4.1|=0.5447
72607364|NCT02452047|144742744|OTHER|Adjusted difference in EFU FCR %|Difference in EFU FCR %|24.7|||||TWO_SIDED|90.0|3.8|51.4|||||Miettinen and Nurminen method stratified by infection-site stratum|||51.4|3.8|
72607365|NCT02452047|144742745|OTHER|Difference in percentages|Difference in FMR %|0.0|||||TWO_SIDED|90.0|-20.8|36.6|||||Miettinen \& Nurminen method|||36.6|-20.8|
72607366|NCT02452047|144742746|OTHER|Difference in percentages|Difference in FMR %|0.0|||||TWO_SIDED|90.0|-20.8|36.6|||||Miettinen \& Nurminen method|||36.6|-20.8|
72607367|NCT02452047|144742747|OTHER|Difference in percentages|Difference in FMR %|-27.3|||||TWO_SIDED|90.0|-52.8|12.8|||||Miettinen \& Nurminen method|||12.8|-52.8|
72607368|NCT00288912|144742748|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6||||0.007|TWO_SIDED|95.0|-1.0|0.2|||Mixed Models Analysis||The mean difference (final values) is based on differences in the outcome between study groups at 12-month follow-up, in the context of the mixed models.|Primary hypothesis: OA self-management intervention results in greater improvement in AIMS2 pain score than usual care or health education control. Sample size estimate based on detecting 0.57 point (14%) difference between groups. Analyses were linear mixed models, intent-to-treat basis.||0.2|-1.0|0.007
72607369|NCT00288912|144742748|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4||||0.105|TWO_SIDED|95.0|-0.8|0.1|||Mixed Models Analysis||The mean difference (final values) is based on differences in the outcome between study groups at 12-month follow-up, in the context of the mixed models.|Primary hypothesis: OA self-management intervention results in greater improvement in AIMS2 pain score than usual care or health education control. Sample size estimate based on detecting 0.57 point (14%) difference between groups. Analyses were linear mixed models, intent-to-treat basis.||0.1|-0.8|0.105
72325167|NCT01214837|144173592|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI for the between group difference (MenACWY3 minus Routine) in percentage of subjects with IgG concentration ≥ 0.35 μg/mL against each pneumococcal anti-capsular polysaccharide is greater than -10%.|Vaccine group difference|-3.0|||||TWO_SIDED|95.0|-11.9|6.0|||Miettinen and Nurminen method|||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 2 doses of MenACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 7 months of age for Serotype 3.||6|-11.9|
72325168|NCT01214837|144173592|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI for the between group difference (MenACWY4 minus Routine) in percentage of subjects with IgG concentration ≥ 0.35 μg/mL against each pneumococcal anti-capsular polysaccharide is greater than -10%.|Vaccine group difference|5.3|||||TWO_SIDED|95.0|-3.3|13.7|||Miettinen and Nurminen method|||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 3 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 7 months of age for Serotype 3.||13.7|-3.3|
72416831|NCT03492281|144344347|SUPERIORITY||Difference in percentage|6.8|||=|0.0235|TWO_SIDED|95.0|0.9|12.7|||Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel risk difference estimate was stratified by sex and OAB type (wet/dry), with weights proposed by Greenland and Robins.||||12.7|0.9|=0.0235
72416832|NCT03492281|144344347|SUPERIORITY||Difference in percentage|3.7|||=|0.24|TWO_SIDED|95.0|-2.5|10.0|||Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel risk difference estimate was stratified by sex and OAB type (wet/dry), with weights proposed by Greenland and Robins.||||10.0|-2.5|=0.2400
72416833|NCT03492281|144344348|SUPERIORITY||Least Squares Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.16|<|0.0001|TWO_SIDED|95.0|-1.0|-0.4||Hypothesis testing was performed for vibegron minus placebo.|MMRM|||||-0.4|-1.0|<0.0001
72607370|NCT00288912|144742749|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2||||0.093|TWO_SIDED|95.0|-0.5|0.0|||Mixed Models Analysis||The mean difference (final values) is based on differences in the outcome between study groups at 12-month follow-up, in the context of the mixed models.|Secondary hypothesis: OA self-management intervention results in greater improvement in AIMS2 function score than usual care or health education control. Analyses were linear mixed models, intent-to-treat basis.||0.0|-0.5|0.093
72607371|NCT00288912|144742749|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.43|TWO_SIDED|95.0|-0.2|0.2|||Mixed Models Analysis||The mean difference (final values) is based on differences in the outcome between study groups at 12-month follow-up, in the context of the mixed models.|Secondary hypothesis: OA self-management intervention results in greater improvement in AIMS2 function score than usual care or health education control. Analyses were linear mixed models, intent-to-treat basis.||0.2|-0.2|0.43
72607372|NCT00288912|144742750|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||0.78|TWO_SIDED|95.0|-0.3|0.4|||Mixed Models Analysis||The mean difference (final values) is based on differences in the outcome between study groups at 12-month follow-up, in the context of the mixed models.|Secondary hypothesis: OA self-management intervention results in greater improvement in AIMS2 affect score than usual care or health education control. Analyses were linear mixed models, intent-to-treat basis.||0.4|-0.3|0.78
72607373|NCT00288912|144742750|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.79|TWO_SIDED|95.0|-0.3|0.4|||Mixed Models Analysis||The mean difference (final values) is based on differences in the outcome between study groups at 12-month follow-up, in the context of the mixed models.|Secondary hypothesis: OA self-management intervention results in greater improvement in AIMS2 affect score than usual care or health education control. Analyses were linear mixed models, intent-to-treat basis.||0.4|-0.3|0.79
72607374|NCT00288912|144742751|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.4||||0.043|TWO_SIDED|95.0|0.0|0.8|||Mixed Models Analysis||The mean difference (final values) is based on differences in the outcome between study groups at 12-month follow-up, in the context of the mixed models.|Secondary hypothesis: OA self-management intervention results in greater improvement in arthritis self-efficacy score than usual care or health education control. Analyses were linear mixed models, intent-to-treat basis.||0.8|0.0|0.043
72607375|NCT00288912|144742751|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.4||||0.066|TWO_SIDED|95.0|0.0|0.7|||Mixed Models Analysis||The mean difference (final values) is based on differences in the outcome between study groups at 12-month follow-up, in the context of the mixed models.|Secondary hypothesis: OA self-management intervention results in greater improvement in arthritis self-efficacy score than usual care or health education control. Analyses were linear mixed models, intent-to-treat basis.||0.7|0.0|0.066
72607376|NCT02059239|144742786|OTHER|Simple proportion in autologous group with exact (Clopper-Pearson) 95% confidence interval.|Proportion (percent)|88.9|||||TWO_SIDED|95.0|65.3|98.6||||||||98.6|65.3|
72607377|NCT02059239|144742786|OTHER|Simple proportion in allogeneic group with exact (Clopper-Pearson) 95% confidence interval.|Proportion (percent)|81.3|||||TWO_SIDED|95.0|54.4|95.9||||||||95.9|54.4|
72607378|NCT02059239|144742787|OTHER|Simple proportion in autologous group with exact (Clopper-Pearson) 95% confidence interval.|Proportion (percent)|100.0|||||TWO_SIDED|95.0|79.4|100.0||||||||100.0|79.4|
72607379|NCT02059239|144742787|OTHER|Simple proportion in allogeneic group with exact (Clopper-Pearson) 95% confidence interval.|Proportion (percent)|100.0|||||TWO_SIDED|95.0|75.3|100.0||||||||100.0|75.3|
72607380|NCT02059239|144742788|OTHER|Simple proportion in autologous group with exact (Clopper-Pearson) 95% confidence interval.|Proportion (percent)|100.0|||||TWO_SIDED|95.0|79.4|100.0||||||||100.0|79.4|
72607381|NCT02059239|144742788|OTHER|Simple proportion in allogeneic group with exact (Clopper-Pearson) 95% confidence interval.|Proportion (percent)|92.3|||||TWO_SIDED|95.0|64.0|99.8||||||||99.8|64.0|
72607382|NCT02059239|144742789|OTHER|Simple proportion in autologous group with exact (Clopper-Pearson) 95% confidence interval.|Proportion (percent)|100.0|||||TWO_SIDED|95.0|79.4|100.0||||||||100.0|79.4|
72607383|NCT02059239|144742789|OTHER|Simple proportion in allogeneic group with exact (Clopper-Pearson) 95% confidence interval.|Proportion (percent)|84.6|||||TWO_SIDED|95.0|54.6|98.1||||||||98.1|54.6|
72607384|NCT02059239|144742790|OTHER|Simple proportion in autologous group with exact (Clopper-Pearson) 95% confidence interval.|Proportion (percent)|100.0|||||TWO_SIDED|95.0|79.4|100.0||||||||100.0|79.4|
72607385|NCT02059239|144742790|OTHER|Simple proportion in allogeneic group with exact (Clopper-Pearson) 95% confidence interval.|Proportion (percent)|46.2|||||TWO_SIDED|95.0|19.2|74.9||||||||74.9|19.2|
72607386|NCT02059239|144742791|OTHER|Simple proportion in autologous group with exact (Clopper-Pearson) 95% confidence interval.|Proportion (percent)|0.0|||||TWO_SIDED|95.0|0.0|20.6||||||||20.6|0.0|
72607387|NCT02059239|144742791|OTHER|Simple proportion in allogeneic group with exact (Clopper-Pearson) 95% confidence interval.|Proportion (percent)|15.4|||||TWO_SIDED|95.0|1.9|45.4||||||||45.4|1.9|
72607388|NCT02059239|144742792|OTHER|Simple proportion (objective response: CR+PR) in autologous group with exact (Clopper-Pearson) 95% confidence interval.|Proportion (percent)|66.7|||||TWO_SIDED|95.0|41.0|86.7||||||||86.7|41.0|
72607389|NCT02059239|144742792|OTHER|Simple proportion (objective response: CR+PR) in allogeneic group with exact (Clopper-Pearson) 95% confidence interval.|Proportion (percent)|43.8|||||TWO_SIDED|95.0|19.8|70.1||||||||70.1|19.8|
72607390|NCT02059239|144742793|OTHER|Simple proportion (objective response: CR+PR) in autologous group with exact (Clopper-Pearson) 95% confidence interval.|Proportion (percent)|87.5|||||TWO_SIDED|95.0|61.7|98.4||||||||98.4|61.7|
72607391|NCT02059239|144742793|OTHER|Simple proportion (objective response: CR+PR) in allogeneic group with exact (Clopper-Pearson) 95% confidence interval.|Proportion (percent)|76.9|||||TWO_SIDED|95.0|46.2|95.0||||||||95.0|46.2|
72607392|NCT02059239|144742794|OTHER|Simple proportion (objective response: CR+PR) in autologous group with exact (Clopper-Pearson) 95% confidence interval.|Proportion (percent)|81.3|||||TWO_SIDED|95.0|54.4|96.0||||||||96.0|54.4|
72607393|NCT02059239|144742794|OTHER|Simple proportion (objective response: CR+PR) in allogeneic group with exact (Clopper-Pearson) 95% confidence interval.|Proportion (percent)|30.8|||||TWO_SIDED|95.0|9.1|61.4||||||||61.4|9.1|
72607394|NCT02059239|144742795|OTHER|Median PFS in allogeneic group with exact (Clopper-Pearson) 95% confidence interval.|Median (95% CI)|8.0|||||TWO_SIDED|95.0|5.0|25.0||||||||25|5|
72607395|NCT02219685|144742796|SUPERIORITY_OR_OTHER|||||||0.58||||||This p-value for treatment effect on basal ganglia was based on a two sample t-test assuming equal variances.|t-test, 2 sided|||||||0.58
72607396|NCT02219685|144742796|SUPERIORITY_OR_OTHER|||||||0.48||||||This p-value for treatment effect on frontal cortex was based on a two sample t-test assuming equal variances.|t-test, 2 sided|||||||0.48
72607397|NCT02219685|144742796|SUPERIORITY_OR_OTHER|||||||0.96||||||This p-value for treatment effect on dorsolateral prefrontal cortex was based on a two sample t-test assuming equal variances.|t-test, 2 sided|||||||0.96
72607398|NCT02219685|144742797|SUPERIORITY_OR_OTHER|||||||0.54||||||This p-value for treatment effect on basal ganglia was based on a two sample t-test assuming equal variances.|t-test, 2 sided|||||||0.54
72607399|NCT02219685|144742797|SUPERIORITY_OR_OTHER|||||||0.57||||||This p-value for treatment effect on frontal cortex was based on a two sample t-test assuming equal variances.|t-test, 2 sided|||||||0.57
72607400|NCT02219685|144742797|SUPERIORITY_OR_OTHER|||||||0.63||||||This p-value for treatment effect on dorsolateral prefrontal cortex was based on a two sample t-test assuming equal variances.|t-test, 2 sided|||||||0.63
72607401|NCT02219685|144742798|SUPERIORITY_OR_OTHER|||||||0.7||||||This p-value for treatment effect on basal ganglia was based on a two sample t-test assuming equal variances.|t-test, 2 sided|||||||0.70
72325169|NCT01214837|144173592|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI for the between group difference (MenACWY3 minus Routine) in percentage of subjects with IgG concentration ≥ 0.35 μg/mL against each pneumococcal anti-capsular polysaccharide is greater than -10%.|Vaccine group difference|-2.4|||||TWO_SIDED|95.0|-7.5|2.3|||Miettinen and Nurminen method|||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 2 doses of MenACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 7 months of age for Serotype 4.||2.3|-7.5|
72325170|NCT01214837|144173592|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI for the between group difference (MenACWY4 minus Routine) in percentage of subjects with IgG concentration ≥ 0.35 μg/mL against each pneumococcal anti-capsular polysaccharide is greater than -10%.|Vaccine group difference|0.3|||||TWO_SIDED|95.0|-4.4|4.7|||Miettinen and Nurminen method|||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 3 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 7 months of age for Serotype 4.||4.7|-4.4|
72325171|NCT01214837|144173592|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI for the between group difference (MenACWY3 minus Routine) in percentage of subjects with IgG concentration ≥ 0.35 μg/mL against each pneumococcal anti-capsular polysaccharide is greater than -10%.|Vaccine group difference|-4.3|||||TWO_SIDED|95.0|-12.1|3.4|||Miettinen and Nurminen method|||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 2 doses of MenACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 7 months of age for Serotype 5.||3.4|-12.1|
72325172|NCT01214837|144173592|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI for the between group difference (MenACWY4 minus Routine) in percentage of subjects with IgG concentration ≥ 0.35 μg/mL against each pneumococcal anti-capsular polysaccharide is greater than -10%.|Vaccine group difference|4.9|||||TWO_SIDED|95.0|-1.9|11.8|||Miettinen and Nurminen method|||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 3 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 7 months of age for Serotype 5.||11.8|-1.9|
72325173|NCT01214837|144173592|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI for the between group difference (MenACWY3 minus Routine) in percentage of subjects with IgG concentration ≥ 0.35 μg/mL against each pneumococcal anti-capsular polysaccharide is greater than -10%.|Vaccine group difference|0.04|||||TWO_SIDED|95.0|-3.7|3.8|||Miettinen and Nurminen method|||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 2 doses of MenACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 7 months of age for Serotype 6A.||3.8|-3.7|
72325174|NCT01214837|144173592|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI for the between group difference (MenACWY4 minus Routine) in percentage of subjects with IgG concentration ≥ 0.35 μg/mL against each pneumococcal anti-capsular polysaccharide is greater than -10%.|Vaccine group difference|1.2|||||TWO_SIDED|95.0|-2.2|4.8|||Miettinen and Nurminen method|||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 3 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 7 months of age for Serotype 6A.||4.8|-2.2|
72416834|NCT03492281|144344348|SUPERIORITY||Least Squares Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.17|=|0.0074|TWO_SIDED|95.0|-0.8|-0.1||Comparisons between tolterodine ER and placebo are considered descriptive.|MMRM|||||-0.1|-0.8|=0.0074
72607402|NCT02219685|144742798|SUPERIORITY_OR_OTHER|||||||0.21||||||This p-value for treatment effect on frontal cortex was based on a two sample t-test assuming equal variances.|t-test, 2 sided|||||||0.21
72607403|NCT02219685|144742798|SUPERIORITY_OR_OTHER|||||||0.59||||||This p-value for treatment effect on dorsolateral prefrontal cortex was based on a two sample t-test assuming equal variances.|t-test, 2 sided|||||||0.59
72416835|NCT03492281|144344349|SUPERIORITY||Least Squares Mean Difference|3.6|STANDARD_ERROR_OF_MEAN|1.24|=|0.0039|TWO_SIDED|95.0|1.2|6.0||Hypothesis testing was performed for vibegron minus placebo.|MMRM|||||6.0|1.2|=0.0039
72416836|NCT03492281|144344349|SUPERIORITY||Least Squares Mean Difference|3.1|STANDARD_ERROR_OF_MEAN|1.32|=|0.021|TWO_SIDED|95.0|0.5|5.7||Comparisons between tolterodine ER and placebo are considered descriptive.|MMRM|||||5.7|0.5|=0.0210
72607404|NCT02219685|144742799|SUPERIORITY_OR_OTHER|||||||0.0795||||||The p-value was from ANCOVA model for change from baseline with treatment group and baseline as covariates.|ANCOVA|||||||0.0795
72607405|NCT02219685|144742800|SUPERIORITY_OR_OTHER|||||||0.7007||||||The p-value was from ANCOVA model for change from baseline with treatment group and baseline as covariates.|ANCOVA|||||||0.7007
72607406|NCT02219685|144742801|SUPERIORITY_OR_OTHER|||||||0.2677||||||The p-value was ANCOVA model for change from baseline with treatment group and baseline as covariates.|ANCOVA|||||||0.2677
72607407|NCT02219685|144742802|SUPERIORITY_OR_OTHER|||||||0.987||||||The p-value was from ANCOVA model for change from baseline with treatment group and baseline as covariates.|ANCOVA|||||||0.9870
72325175|NCT01214837|144173592|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI for the between group difference (MenACWY3 minus Routine) in percentage of subjects with IgG concentration ≥ 0.35 μg/mL against each pneumococcal anti-capsular polysaccharide is greater than -10%.|Vaccine group difference|-0.3|||||TWO_SIDED|95.0|-8.4|7.7|||Miettinen and Nurminen method|||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 2 doses of MenACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 7 months of age for Serotype 6B.||7.7|-8.4|
72416837|NCT03492281|144344350|SUPERIORITY||Least Squares Mean Difference|21.2|STANDARD_ERROR_OF_MEAN|3.52|<|0.0001|TWO_SIDED|95.0|14.3|28.1||Hypothesis testing was performed for vibegron minus placebo.|MMRM|||||28.1|14.3|<0.0001
72416838|NCT03492281|144344350|SUPERIORITY||Least Squares Mean Difference|13.3|STANDARD_ERROR_OF_MEAN|3.76|<|0.001|TWO_SIDED|95.0|5.9|20.7||Comparisons between tolterodine ER and placebo are considered descriptive.|MMRM|||||20.7|5.9|<0.001
72607408|NCT02219685|144742803|SUPERIORITY_OR_OTHER|||||||0.3388||||||The p-value was from ANCOVA model for change from baseline with treatment group and baseline as covariates.|ANCOVA|||||||0.3388
72325176|NCT01214837|144173592|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI for the between group difference (MenACWY4 minus Routine) in percentage of subjects with IgG concentration ≥ 0.35 μg/mL against each pneumococcal anti-capsular polysaccharide is greater than -10%.|Vaccine group difference|10.2|||||TWO_SIDED|95.0|3.4|17.2|||Miettinen and Nurminen method|||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 3 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 7 months of age for Serotype 6B.||17.2|3.4|
72325177|NCT01214837|144173592|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI for the between group difference (MenACWY3 minus Routine) in percentage of subjects with IgG concentration ≥ 0.35 μg/mL against each pneumococcal anti-capsular polysaccharide is greater than -10%.|Vaccine group difference|0.6|||||TWO_SIDED|95.0|-1.7|3.5|||Miettinen and Nurminen method|||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 2 doses of MenACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 7 months of age for Serotype 7F.||3.5|-1.7|
72325178|NCT01214837|144173592|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI for the between group difference (MenACWY4 minus Routine) in percentage of subjects with IgG concentration ≥ 0.35 μg/mL against each pneumococcal anti-capsular polysaccharide is greater than -10%.|Vaccine group difference|0.6|||||TWO_SIDED|95.0|-2.1|3.5|||Miettinen and Nurminen method|||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 3 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 7 months of age for Serotype 7F.||3.5|-2.1|
72325179|NCT01214837|144173592|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI for the between group difference (MenACWY3 minus Routine) in percentage of subjects with IgG concentration ≥ 0.35 μg/mL against each pneumococcal anti-capsular polysaccharide is greater than -10%.|Vaccine group difference|-3.1|||||TWO_SIDED|95.0|-9.7|3.4|||Miettinen and Nurminen method|||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 2 doses of MenACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 7 months of age for Serotype 9V.||3.4|-9.7|
72325180|NCT01214837|144173592|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI for the between group difference (MenACWY4 minus Routine) in percentage of subjects with IgG concentration ≥ 0.35 μg/mL against each pneumococcal anti-capsular polysaccharide is greater than -10%.|Vaccine group difference|4.0|||||TWO_SIDED|95.0|-1.5|9.7|||Miettinen and Nurminen method|||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 3 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 7 months of age for Serotype 9V.||9.7|-1.5|
72325181|NCT01214837|144173592|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI for the between group difference (MenACWY3 minus Routine) in percentage of subjects with IgG concentration ≥ 0.35 μg/mL against each pneumococcal anti-capsular polysaccharide is greater than -10%.|vaccine group difference|1.9|||||TWO_SIDED|95.0|-1.2|5.7|||Miettinen and Nurminen method|||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 2 doses of MenACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 7 months of age for Serotype 14.||5.7|-1.2|
72607409|NCT01435759|144742848|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean|3.16|STANDARD_ERROR_OF_MEAN|1.01||0.004|TWO_SIDED||||||MCP-Mod Analysis|The systolic blood pressure p-value was based on a critical value of 1.99 from a multivariate-t distribution with 341 degrees of freedom.|The t-statistic used for this analysis, 3.14, was based on MCP-Mod Analysis for the candidate model EMax.|||||0.004
72607410|NCT01435759|144742848|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Means|2.5|STANDARD_ERROR_OF_MEAN|1.01||0.032|TWO_SIDED||||||MCP-Mod Analysis|The systolic blood pressure p-value was based on a critical value of 1.99 from a multivariate-t distribution with 341 degrees of freedom.|The t-statistic used for this analysis, 2.48, was based on MCP-Mod Analysis for the candidate model Exponential.|||||0.032
72607411|NCT01435759|144742848|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean|3.28|STANDARD_ERROR_OF_MEAN|1.01||0.003|TWO_SIDED||||||MCP-Mod Analysis|The systolic blood pressure p-value was based on a critical value of 1.99 from a multivariate-t distribution with 341 degrees of freedom.|The t-statistic used for this analysis, 3.26 was based on MCP-Mod Analysis for the candidate model Linear.|||||0.003
72607412|NCT01435759|144742848|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Means|2.91|STANDARD_ERROR_OF_MEAN|1.01||0.01|TWO_SIDED||||||MCP-Mod Analysis Method|The systolic blood pressure p-value was based on a critical value of 1.99 from a multivariate-t distribution with 341 degrees of freedom.|The t-statistic used for this analysis, 2.88, was based on MCP-Mod Analysis for the candidate model Logistic1.|||||0.010
72325182|NCT01214837|144173592|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI for the between group difference (MenACWY3 minus Routine) in percentage of subjects with IgG concentration ≥ 0.35 μg/mL against each pneumococcal anti-capsular polysaccharide is greater than -10%.|Vaccine group difference|2.5|||||TWO_SIDED|95.0|-0.2|6.3|||Miettinen and Nurminen method|||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 3 doses of MenACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 7 months of age for Serotype 14.||6.3|-0.2|
72416839|NCT03492281|144344351|SUPERIORITY||Least Squares Mean Difference|3.8|STANDARD_ERROR_OF_MEAN|1.06|<|0.001|TWO_SIDED|95.0|1.7|5.8||Hypothesis testing was performed for vibegron minus placebo.|MMRM|||||5.8|1.7|<0.001
72325183|NCT01214837|144173592|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI for the between group difference (MenACWY3 minus Routine) in percentage of subjects with IgG concentration ≥ 0.35 μg/mL against each pneumococcal anti-capsular polysaccharide is greater than -10%.|Vaccine group difference|-2.5|||||TWO_SIDED|95.0|-6.3|-0.2|||Miettinen and Nurminen method|||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 2 doses of MenACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 7 months of age for Serotype 18C.||-0.2|-6.3|
72416840|NCT03492281|144344351|SUPERIORITY||Least Squares Mean Difference|2.9|STANDARD_ERROR_OF_MEAN|1.13|=|0.0114|TWO_SIDED|95.0|0.6|5.1|||MMRM|||||5.1|0.6|=0.0114
72416841|NCT03492281|144344352|SUPERIORITY||Least Squares Mean Difference|-6.9|STANDARD_ERROR_OF_MEAN|1.17|<|0.0001|TWO_SIDED|95.0|-9.2|-4.6||Hypothesis testing was performed for vibegron minus placebo.|MMRM|||||-4.6|-9.2|<0.0001
72607413|NCT01435759|144742848|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Means|3.15|STANDARD_ERROR_OF_MEAN|1.01||0.005|TWO_SIDED||||||MCP-Mod Analysis|The systolic blood pressure p-value was based on a critical value of 1.99 from a multivariate-t distribution with 341 degrees of freedom.|The t-statistic used for this analysis, 3.12, was based on MCP-Mod Analysis for the candidate model Logistic2.|||||0.005
72416842|NCT03492281|144344352|SUPERIORITY||Least Squares Mean Difference|-4.6|STANDARD_ERROR_OF_MEAN|1.25|<|0.001|TWO_SIDED|95.0|-7.1|-2.2||Comparisons between tolterodine ER and placebo are considered descriptive.|MMRM|||||-2.2|-7.1|<0.001
72607414|NCT01435759|144742849|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Means|2.16|STANDARD_ERROR_OF_MEAN|0.75||0.011|TWO_SIDED||||||MCP-Mod Analysis|The diastolic blood pressure p-value was based on a critical value of 1.99 from a multivariate-t distribution with 341 degrees of freedom.|The t-statistic used for this analysis, 2.86 was based on MCP-Mod Analysis for the candidate model Emax.|||||0.011
72607415|NCT01435759|144742849|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Means|1.95|STANDARD_ERROR_OF_MEAN|0.75||0.023|TWO_SIDED||||||MCP-Mod Analysis|The diastolic blood pressure p-value was based on a critical value of 1.99 from a multivariate-t distribution with 341 degrees of freedom.|The t-statistic used for this analysis, 2.59, was based on MCP-Mod Analysis for the candidate model Exponential.|||||0.023
72607416|NCT01435759|144742849|SUPERIORITY_OR_OTHER_LEGACY||MCP-Mod Analysis|2.47|STANDARD_ERROR_OF_MEAN|0.75||0.003|TWO_SIDED||||||Least Squares Means|The diastolic blood pressure p-value was based on a critical value of 1.99 from a multivariate-t distribution with 341 degrees of freedom.|The t-statistic used for this analysis, 3.28, was based on MCP-Mod Analysis for the candidate model Linear.|||||0.003
72607417|NCT01435759|144742849|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Means|2.22|STANDARD_ERROR_OF_MEAN|0.76||0.009|TWO_SIDED||||||MCP-Mod Analysis|The diastolic blood pressure p-value was based on a critical value of 1.99 from a multivariate-t distribution with 341 degrees of freedom.|The t-statistic used for this analysis, 2.93, was based on MCP-Mod Analysis for the candidate model Logistic1.|||||0.009
72607418|NCT01435759|144742849|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Means|2.37|STANDARD_ERROR_OF_MEAN|0.76||0.005|TWO_SIDED||||||MCP-Mod Analysis|The diastolic blood pressure p-value was based on a critical value of 1.99 from a multivariate-t distribution with 341 degrees of freedom.|The t-statistic used for this analysis, 3.13, was based on MCP-Mod Analysis for the candidate model Logistic2.|||||0.005
72607419|NCT01435759|144742850|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Means|4.45|STANDARD_ERROR_OF_MEAN|1.05|<|0.001|TWO_SIDED||||||MCP-Mod Analysis|The pulse p-value was based on a critical value of 1.99 from a multivariate-t distribution with 341 degrees of freedom.|The t-statistic used for this analysis, 4.24, was based on MCP-Mod Analysis for the candidate model Emax|||||<0.001
72607420|NCT01435759|144742850|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Means|3.52|STANDARD_ERROR_OF_MEAN|1.05||0.002|TWO_SIDED||||||MCP-Mod Analysis|The pulse p-value was based on a critical value of 1.99 from a multivariate-t distribution with 341 degrees of freedom.|The t-statistic used for this analysis, 3.36, was based on MCP-Mod Analysis for the candidate model Expontential.|||||0.002
72607421|NCT01435759|144742850|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Means|4.3|STANDARD_ERROR_OF_MEAN|1.05|<|0.001|TWO_SIDED||||||MCP-Mod Analysis|The pulse p-value was based on a critical value of 1.99 from a multivariate-t distribution with 341 degrees of freedom.|The t-statistic used for this analysis, 4.10, was based on MCP-Mod Analysis for the candidate model Linear.|||||<0.001
72607422|NCT01435759|144742850|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Means|4.63|STANDARD_ERROR_OF_MEAN|1.05|<|0.001|TWO_SIDED||||||MCP-Mod Analysis|The pulse p-value was based on a critical value of 1.99 from a multivariate-t distribution with 341 degrees of freedom.|The t-statistic used for this analysis, 4.39, was based on MCP-Mod Analysis for the candidate model Logistic1.|||||<0.001
72607423|NCT01435759|144742850|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Means|4.63|STANDARD_ERROR_OF_MEAN|1.05|<|0.001|TWO_SIDED||||||MCP-Mod Analysis|The pulse p-value was based on a critical value of 1.99 from a multivariate-t distribution with 341 degrees of freedom.|The t-statistic used for this analysis, 4.39 was based on MCP-Mod Analysis for the candidate model Logistic2.|||||<0.001
72607424|NCT01435759|144742851|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Means|-0.11|STANDARD_ERROR_OF_MEAN|1.07||1|ONE_SIDED|||||Any p-value \<=0.10 indicates successful establishment of dose-response relationship.|MCP-Mod Analysis Method|The adjusted p-value was based on a critical value of 2.02 from a multivariate-t distribution with 341 degrees of freedom.|The t-statistic used for this analysis, 0.10, was based on MCP-Mod Analysis from the linear contrast using optimal coefficients for the pre-specified candidate model Betamod.|Analysis of Dose-Response Using the MCP-Mod Analysis Method||||1.000
72416843|NCT03492281|144344353|SUPERIORITY||Difference in percentage|12.4|||<|0.0001|TWO_SIDED|95.0|6.7|18.1||CMH=Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel|The CMH risk difference estimate was stratified by OAB type (wet/dry) and sex (female/male), with weights proposed by Greenland and Robins.||||18.1|6.7|<0.0001
72607425|NCT01435759|144742851|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Means|0.43|STANDARD_ERROR_OF_MEAN|1.06||0.942|ONE_SIDED|||||Any p-value \<=0.10 indicates successful establishment of dose-response relationship.|MCP-Mod Analysis|The adjusted p-value was based on a critical value of 2.02 from a multivariate-t distribution with 341 degrees of freedom.|The t-statistic used for this analysis, 0.41, was based on MCP-Mod Analysis from the linear contrast using optimal coefficients for the pre-specified candidate model Emax.|Analysis of Dose-Response Using the MCP-Mod Analysis Method.||||0.942
72607426|NCT01435759|144742851|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Means|0.21|STANDARD_ERROR_OF_MEAN|1.06||0.995|ONE_SIDED|||||Any p-value \<=0.10 indicates successful establishment of dose-response relationship.|MCP-Mod Analysis|The adjusted p-value was based on a critical value of 2.02 from a multivariate-t distribution with 341 degrees of freedom.|The t-statistic used for this analysis, 0.20, was based on MCP-Mod Analysis from the linear contrast using optimal coefficients for the pre-specified candidate model Linear.|Analysis of Dose-Response Using the MCP-Mod Analysis Method.||||0.995
72607427|NCT01435759|144742851|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Means|-0.32|STANDARD_ERROR_OF_MEAN|1.07||0.978|ONE_SIDED|||||Any p-value \<=0.10 indicates successful establishment of dose-response relationship.|MCP-Mod Analysis|The adjusted p-value was based on a critical value of 2.02 from a multivariate-t distribution with 341 degrees of freedom.|The t-statistic used for this analysis, 0.30, was based on MCP-Mod Analysis from the linear contrast using optimal coefficients for the pre-specified candidate model Logistic.|Analysis of Dose-Response Using the MCP-Mod Analysis Method||||0.978
72607428|NCT01211145|144742852|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.37||||0.312|TWO_SIDED|95.0|0.75|2.5||Unadjusted|Regression, Logistic||ZOMIG 0.5 mg/Placebo|||2.50|0.75|.312
72607429|NCT01211145|144742852|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.76||||0.071|TWO_SIDED|95.0|0.95|3.26||Unadjusted|Regression, Logistic||ZOMIG 2.5 mg/Placebo|||3.26|0.95|.071
72607430|NCT01211145|144742852|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.18|||<|0.001|TWO_SIDED|95.0|1.4|3.39||Unadjusted|Regression, Logistic||ZOMIG 5.0 mg/Placebo|||3.39|1.40|<.001
72607431|NCT01211145|144742853|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.15||||0.575|TWO_SIDED|95.0|0.7|1.91||Unadjusted|Regression, Logistic||ZOMIG 0.5 mg/Placebo|||1.91|0.70|.575
72607432|NCT01211145|144742853|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.87||||0.032|TWO_SIDED|95.0|1.06|3.31||Unadjusted|Regression, Logistic||ZOMIG 2.5 mg/Placebo|||3.31|1.06|.032
72607433|NCT01211145|144742853|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.33||||0.137|TWO_SIDED|95.0|0.91|1.95||Unadjusted|Regression, Logistic||ZOMIG 5.0 mg/Placebo|||1.95|0.91|.137
72607434|NCT01211145|144742854|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.2||||0.458|TWO_SIDED|95.0|0.74|1.96||Unadjusted|Regression, Logistic||ZOMIG 0.5 mg/Placebo|||1.96|0.74|.458
72607435|NCT01211145|144742854|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.82||||0.021|TWO_SIDED|95.0|1.09|3.03||Unadjusted|Regression, Logistic||ZOMIG 2.5 mg/Placebo|||3.03|1.09|.021
72607436|NCT01211145|144742854|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.61||||0.01|TWO_SIDED|95.0|1.12|2.32||Unadjusted|Regression, Logistic||ZOMIG 5.0 mg/Placebo|||2.32|1.12|.010
72607437|NCT01211145|144742855|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.09||||0.753|TWO_SIDED|95.0|0.64|1.84||Unadjusted|Regression, Logistic||ZOMIG 0.5 mg/Placebo|||1.84|0.64|.753
72607438|NCT01211145|144742855|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.55||||0.145|TWO_SIDED|95.0|0.86|2.79||Unadjusted|Regression, Logistic||ZOMIG 2.5 mg/Placebo|||2.79|0.86|.145
72607439|NCT01211145|144742855|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.37||||0.127|TWO_SIDED|95.0|0.91|2.04||Unadjusted|Regression, Logistic||ZOMIG 5.0 mg/Placebo|||2.04|0.91|.127
72607440|NCT01211145|144742856|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.35||||0.274|TWO_SIDED|95.0|0.79|2.32||Unadjusted|Regression, Logistic||ZOMIG 0.5 mg/Placebo|||2.32|0.79|.274
72607441|NCT01211145|144742856|SUPERIORITY_OR_OTHER||Odds Ratio, log|1.67||||0.067|TWO_SIDED|95.0|0.96|2.91||Unadjusted|Regression, Logistic||ZOMIG 2.5 mg/Placebo|||2.91|0.96|.067
72607442|NCT01211145|144742856|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.38||||0.127|TWO_SIDED|95.0|0.91|2.08||Unadjusted|Regression, Logistic||ZOMIG 5.0 mg/Placebo|||2.08|0.91|.127
72607443|NCT01211145|144742857|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.67||||0.153|TWO_SIDED|95.0|0.38|1.16||Unadjusted|Regression, Logistic||ZOMIG 0.5 mg/Placebo|||1.16|0.38|.153
72607444|NCT01211145|144742857|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.59||||0.087|TWO_SIDED|95.0|0.33|1.08||Unadjusted|Regression, Logistic||ZOMIG 2.5 mg/Placebo|||1.08|0.33|.087
72607445|NCT01211145|144742857|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.54||||0.004|TWO_SIDED|95.0|0.36|0.83||Unadjusted|Regression, Logistic||ZOMIG 5.0 mg/Placebo|||0.83|0.36|.004
72607446|NCT04622969|144742899|SUPERIORITY||Mean Difference (Net)|-21.6|STANDARD_ERROR_OF_MEAN|5.157|<|0.001|TWO_SIDED||||||ANCOVA|||||||<.001
72607447|NCT04622969|144742901|SUPERIORITY||Mean Difference (Net)|7.12|STANDARD_ERROR_OF_MEAN|12.05|=|0.56|TWO_SIDED||||||Mixed Models Analysis|||||||=0.56
72607448|NCT04622969|144742905|SUPERIORITY||Mean Difference (Net)|0.0015|STANDARD_ERROR_OF_MEAN|0.145|=|0.99|TWO_SIDED||||||Mixed Models Analysis|||||||=0.99
72607449|NCT04622969|144742907|SUPERIORITY||Mean Difference (Net)|-0.264|STANDARD_ERROR_OF_MEAN|0.121|<|0.05|TWO_SIDED||||||ANCOVA|||||||<.05
72607450|NCT04622969|144742909|SUPERIORITY||Mean Difference (Net)|-5.573|STANDARD_ERROR_OF_MEAN|1.802|<|0.01|TWO_SIDED||||||ANCOVA|||||||<.01
72607451|NCT04622969|144742911|SUPERIORITY||Mean Difference (Net)|3.509|STANDARD_ERROR_OF_MEAN|1.842|=|0.062|TWO_SIDED||||||ANCOVA|||||||=.062
72607452|NCT04622969|144742911|SUPERIORITY||Mean Difference (Net)|0.047|STANDARD_ERROR_OF_MEAN|0.17|=|0.78|TWO_SIDED||||||Mixed Models Analysis|||||||=0.78
72607453|NCT05616013|144742927|SUPERIORITY||LS Mean Change difference|-14.5|||<|0.001|TWO_SIDED|95.0|-18.0|-11.0|||ANCOVA|||Bima 30mg/kg + Sema 2.4mg vs Placebo||-11.0|-18.0|<0.001
72607454|NCT05616013|144742927|SUPERIORITY||LS Mean Change difference|-10.5|||<|0.001|TWO_SIDED|95.0|-14.0|-7.09|||ANCOVA|||Bima 30mg/kg + Sema 1.0mg vs Placebo||-7.09|-14.0|<0.001
72607455|NCT05616013|144742927|SUPERIORITY||LS Mean Change difference|-11.0|||<|0.001|TWO_SIDED|95.0|-14.4|-7.55|||ANCOVA|||Bima 10mg/kg + Sema 2.4mg vs Placebo||-7.55|-14.4|<0.001
72607456|NCT05616013|144742927|SUPERIORITY||LS Mean Change difference|-9.41|||<|0.001|TWO_SIDED|95.0|-12.9|-5.93|||ANCOVA|||Bima 10mg/kg + Sema 1.0mg vs Placebo||-5.93|-12.9|<.001
72416844|NCT03492281|144344353|SUPERIORITY||Difference in percentage|6.9|||=|0.0236|TWO_SIDED|95.0|0.9|12.8|||Cochran-Mantel-Haenszel|The CMH risk difference estimate was stratified by OAB type (wet/dry) and sex (female/male), with weights proposed by Greenland and Robins.||||12.8|0.9|=0.0236
72416845|NCT03492281|144344354|SUPERIORITY||Difference in percentage|11.7|||<|0.001|TWO_SIDED|95.0|4.7|18.6|||Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel risk difference estimate was stratified by sex (female/male), with weights proposed by Greenland and Robins.||||18.6|4.7|<0.001
72607457|NCT05616013|144742927|SUPERIORITY||LS Mean Change difference|-10.9|||<|0.001|TWO_SIDED|95.0|-14.4|-7.46|||ANCOVA|||Sema 2.4mg vs Placebo||-7.46|-14.4|<0.001
72607458|NCT05616013|144742927|SUPERIORITY||LS Mean Change difference|-6.45|||<|0.001|TWO_SIDED|95.0|-9.96|-2.94|||ANCOVA|||Sema 1.0mg vs Placebo||-2.94|-9.96|<0.001
72607459|NCT05616013|144742927|SUPERIORITY||LS Mean Change difference|-5.94|||<|0.001|TWO_SIDED|95.0|-9.47|-2.41|||ANCOVA|||Bima 30mg/kg vs Placebo||-2.41|-9.47|<0.001
72607460|NCT05616013|144742927|SUPERIORITY||LS Mean Change difference|-2.68||||0.133|TWO_SIDED|95.0|-6.18|0.82|||ANCOVA|||Bima 10mg/kg vs Placebo||0.82|-6.18|0.133
72607461|NCT05116202|144742968|SUPERIORITY||Difference in pRR|2.73|||||TWO_SIDED|95.0|-22.25|27.7||||||||27.70|-22.25|
72607462|NCT05116202|144742968|SUPERIORITY||Difference in pRR|-32.27|||||TWO_SIDED|95.0|-65.01|0.46||||||||0.46|-65.01|
72416846|NCT03492281|144344354|SUPERIORITY||Difference in percentage|11.5|||=|0.0022|TWO_SIDED|95.0|4.2|18.9|||Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel risk difference estimate was stratified by sex (female/male), with weights proposed by Greenland and Robins.||||18.9|4.2|=0.0022
72607463|NCT05116202|144742968|SUPERIORITY||Difference in pRR|-17.27|||||TWO_SIDED|95.0|-49.75|15.21||||||||15.21|-49.75|
72607464|NCT05116202|144742970|SUPERIORITY||Difference in pRR|-6.82|||||TWO_SIDED|95.0|-31.31|17.68||||||||17.68|-31.31|
72607465|NCT05116202|144742970|SUPERIORITY||Difference in pRR|-31.82|||||TWO_SIDED|95.0|-63.79|0.16||||||||0.16|-63.79|
72607466|NCT05116202|144742970|SUPERIORITY||Difference in pRR|-21.82|||||TWO_SIDED|95.0|-53.44|9.8||||||||9.80|-53.44|
72607467|NCT05116202|144742971|SUPERIORITY||Hazard Ratio (HR)|2.09|||||TWO_SIDED|95.0|0.42|10.42||||||||10.42|0.42|
72607468|NCT05116202|144742971|SUPERIORITY||Hazard Ratio (HR)|3.95|||||TWO_SIDED|95.0|0.79|19.7||||||||19.70|0.79|
72607469|NCT05116202|144742971|SUPERIORITY||Hazard Ratio (HR)|6.27|||||TWO_SIDED|95.0|0.73|53.7||||||||53.70|0.73|
72607470|NCT05116202|144742972|SUPERIORITY||Hazard Ratio (HR)|1.41|||||TWO_SIDED|95.0|0.25|7.75||||||||7.75|0.25|
72607471|NCT05116202|144742972|SUPERIORITY||Hazard Ratio (HR)|2.09|||||TWO_SIDED|95.0|0.35|12.62||||||||12.62|0.35|
72607472|NCT05116202|144742972|SUPERIORITY||Hazard Ratio (HR)|2.39|||||TWO_SIDED|95.0|0.22|26.32||||||||26.32|0.22|
72607473|NCT05116202|144742973|SUPERIORITY||Hazard Ratio (HR)|0.78|||||TWO_SIDED|95.0|0.05|12.39||||||||12.39|0.05|
72607474|NCT05116202|144742973|SUPERIORITY||Hazard Ratio (HR)|2.59|||||TWO_SIDED|95.0|0.23|28.65||||||||28.65|0.23|
72607475|NCT05116202|144742973|SUPERIORITY||Hazard Ratio (HR)|1.16|||||TWO_SIDED|95.0|0.07|18.58||||||||18.58|0.07|
72607476|NCT05116202|144742974|SUPERIORITY||Difference in ORR|-21.59|||||TWO_SIDED|95.0|-50.55|7.37||||||||7.37|-50.55|
72607477|NCT05116202|144742974|SUPERIORITY||Difference in ORR|-24.09|||||TWO_SIDED|95.0|-58.17|9.99||||||||9.99|-58.17|
72607478|NCT05116202|144742974|SUPERIORITY||Difference in ORR|0.91|||||TWO_SIDED|95.0|-33.58|35.4||||||||35.40|-33.58|
72325184|NCT01214837|144173592|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI for the between group difference (MenACWY4 minus Routine) in percentage of subjects with IgG concentration ≥ 0.35 μg/mL against each pneumococcal anti-capsular polysaccharide is greater than -10%.|Vaccine group difference|-2.2|||||TWO_SIDED|95.0|-6.2|0.2|||Miettinen and Nurminen method|||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 3 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 7 months of age for Serotype 18C.||0.2|-6.2|
72416847|NCT03492281|144344355|SUPERIORITY||Least Squares Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.04|<|0.0001|TWO_SIDED|95.0|-0.3|-0.1||Hypothesis testing was performed for vibegron minus placebo.|MMRM|||||-0.1|-0.3|<0.0001
72416848|NCT03492281|144344355|SUPERIORITY||Least Squares Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.05|=|0.0055|TWO_SIDED|95.0|-0.2|0.0||Hypothesis testing was performed for vibegron minus placebo.|MMRM|||||0.0|-0.2|=0.0055
72607479|NCT03834506|144742986|SUPERIORITY||Hazard Ratio (HR)|0.92||||0.1677|TWO_SIDED|95.0|0.78|1.09||One-sided p-value based on log-rank test stratified by prior treatment with a NHA (abiraterone acetate) and type of metastases at baseline.|Log Rank||HR based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by prior treatment with a NHA (abiraterone acetate) and type of metastases at baseline.|||1.09|0.78|0.1677
72607480|NCT03834506|144742987|SUPERIORITY||Hazard Ratio (HR)|0.85||||0.0335|TWO_SIDED|95.0|0.71|1.01||One-sided p-value based on log-rank test stratified by prior treatment with NHA (abiraterone acetate) and type of metastases at baseline.|Log Rank||HR based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by prior treatment with NHA (abiraterone acetate) and type of metastases at baseline.|||1.01|0.71|0.0335
72607481|NCT03834506|144742988|SUPERIORITY||Hazard Ratio (HR)|0.86||||0.0331|TWO_SIDED|95.0|0.74|1.01||One-sided p-value based on log-rank test stratified by prior treatment with NHA (abiraterone acetate) and type of metastases at baseline.|Log Rank||HR based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by prior treatment with NHA (abiraterone acetate) and type of metastases at baseline.|||1.01|0.74|0.0331
72607482|NCT03834506|144742990|OTHER||Percent Difference|-1.8||||0.6545|TWO_SIDED|95.0|-10.7|7.1||Based on Miettinen \& Nurminen method stratified by prior treatment with a NHA (abiraterone acetate) and type of metastases at baseline.|Miettinen & Nurminen method||Based on Miettinen \& Nurminen method stratified by prior treatment with a NHA (abiraterone acetate) and type of metastases at baseline.|||7.1|-10.7|0.6545
72607483|NCT03834506|144742992|OTHER||Hazard Ratio (HR)|1.05||||0.6178|TWO_SIDED|95.0|0.77|1.43|||Log Rank|One-sided p-value based on log-rank test stratified by prior treatment with NHA (abiraterone acetate) and type of metastases at baseline.|HR based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by prior treatment with NHA (abiraterone acetate) and type of metastases at baseline.|||1.43|0.77|0.6178
72607484|NCT03834506|144742993|OTHER||Hazard Ratio (HR)|1.54||||0.9788|TWO_SIDED|95.0|1.01|2.33|||Log Rank|One-sided p-value based on log-rank test stratified by prior treatment with NHA (abiraterone acetate) and type of metastases at baseline.|HR based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by prior treatment with NHA (abiraterone acetate) and type of metastases at baseline.|||2.33|1.01|0.9788
72607485|NCT03834506|144742994|OTHER||Hazard Ratio (HR)|0.96||||0.297|TWO_SIDED|95.0|0.82|1.12|||Log Rank|One-sided p-value based on log-rank test stratified by prior treatment with NHA (abiraterone acetate) and type of metastases at baseline.|HR based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by prior treatment with NHA (abiraterone acetate) and type of metastases at baseline.|||1.12|0.82|0.2970
72607486|NCT03834506|144742995|OTHER||Hazard Ratio (HR)|0.95||||0.2876|TWO_SIDED|95.0|0.78|1.15|||Log Rank|One-sided p-value based on log-rank test stratified by prior treatment with NHA (abiraterone acetate) and type of metastases at baseline.|HR based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by prior treatment with NHA (abiraterone acetate) and type of metastases at baseline.|||1.15|0.78|0.2876
72607487|NCT04391842|144743006|OTHER||||||<|0.001|||||||ANOVA|||||||<0.001
72607488|NCT04391842|144743007|OTHER||||||<|0.001|||||||t-test, 1 sided|||||||<0.001
72607489|NCT02731300|144743008|SUPERIORITY_OR_OTHER||||||<|0.05||||||the final Week 4 values compared between active tDCS and sham tDCS groups|ANOVA|||the final Week 4 values compared between active tDCS and sham tDCS groups||||<0.05
72416849|NCT03492281|144344356|SUPERIORITY||Least Squares Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.05|<|0.0001|TWO_SIDED|95.0|-0.4|-0.2||Hypothesis testing was performed for vibegron minus placebo.|MMRM|||||-0.2|-0.4|<0.0001
72416850|NCT03492281|144344356|SUPERIORITY||Least Squares Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.06|<|0.001|TWO_SIDED|95.0|-0.3|-0.1||Comparisons between tolterodine ER and placebo are considered descriptive.|MMRM|||||-0.1|-0.3|<0.001
72607490|NCT02731300|144743009|SUPERIORITY_OR_OTHER||||||<|0.05||||||the final Week 4 values compared between active tDCS and sham tDCS groups|ANOVA|||the final Week 4 values compared between active tDCS and sham tDCS groups||||<0.05
72607491|NCT00596271|144743012|NON_INFERIORITY_OR_EQUIVALENCE|"Non-inferiority of the combined administration is postulated, if the lower bounds of both twosided 95% confidence intervals for the GMT ratios (of combined vaccination over single vaccination) are \> 1/2.~This procedure is equivalent to the approach based on a 1-sided test with a significance level of 2.5% for each comparison with the null hypothesis H0 : ratio ≤ 0.5 versus the alternative hypotheses H1 : ratio \> 0.5."|||||<|0.0001||95.0|||||ANOVA|||The primary efficacy analysis will compare the IC51+HAVRIX vs. IC51+Placebo group in terms of the GMT for anti- JEV neutralizing antibody at day 56. An observed cases approach will be applied for the primary analysis||||<0.0001
72607492|NCT00596271|144743016|NON_INFERIORITY_OR_EQUIVALENCE|"Non-inferiority of the combined administration is postulated, if the lower bounds of both twosided 95% confidence intervals for the GMT ratios (of combined vaccination over single vaccination) are \> 1/2.~This procedure is equivalent to the approach based on a 1-sided test with a significance level of 2.5% for each comparison with the null hypothesis H0 : ratio ≤ 0.5 versus the alternative hypotheses H1 : ratio \> 0.5."|||||<|0.0001||95.0|||||ANOVA|||The primary efficacy analysis will compare the IC51+HAVRIX vs. HAVRIX+Placebo group in terms of the GMT for HAV antibody at day 28. An observed cases approach will be applied for the primary analysis.||||<0.0001
72607493|NCT00689338|144743053|SUPERIORITY_OR_OTHER||estimate of survival|53.8|||||TWO_SIDED|95.0|45.9|60.9|||Kaplan-Meier|||Kaplan-Meier estimate of survival at Day 90 (survivor function).||60.9|45.9|
72607494|NCT02668640|144743077|OTHER||||||=|0.0002|||||||Wilcoxon signed-rank test|||||||=0.0002
72607495|NCT02668640|144743078|OTHER||||||=|0.0006|||||||Wilcoxon signed-rank test|||||||=0.0006
72607496|NCT02668640|144743079|OTHER||||||<|0.0001|||||||Wilcoxon signed-rank test|||Median change from baseline in PCS T-score at Week 12||||<0.0001
72607497|NCT02668640|144743079|OTHER||||||=|0.1233|||||||Wilcoxon signed-rank test|||Median change from baseline in MCS T-score at Week 12||||=0.1233
72416851|NCT01506193|144344357|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority with respect to seroconversion rates for measles was concluded if the lower limit of the 95% CI around the difference in seroconversion rates between groups would be \[-10%\] or higher.|Difference in percentage|-0.04|||||TWO_SIDED|95.0|-1.82|2.78||||||"Immune response for anti-measles antibodies~Non-inferiority of Priorix-Tetra™ vaccine co-administered with Meningitec® conjugate vaccine compared to the first dose of Priorix-Tetra™ vaccine alone with respect to anti-measles seroconversion rates (SCRs) at Day 42 after dose 1."||2.78|-1.82|
72416852|NCT01506193|144344357|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority with respect to seroconversion rates for mumps was concluded if the lower limit of the 95% CI around the difference in seroconversion rates between groups would be \[-10%\] or higher.|Difference in percentage|1.29|||||TWO_SIDED|95.0|-3.04|6.67||||||"Immune response for anti-mumps antibodies~Non-inferiority of Priorix-Tetra™ vaccine co-administered with Meningitec® conjugate vaccine compared to the first dose of Priorix-Tetra™ vaccine alone with respect to anti-mumps seroconversion rates (SCRs) at Day 42 after dose 1."||6.67|-3.04|
72607498|NCT02668640|144743079|OTHER||||||<|0.001|||||||Wilcoxon signed-rank test|||Median change from baseline in PCS T-score at Week 24||||<0.001
72607499|NCT02668640|144743079|OTHER||||||=|0.001|||||||Wilcoxon signed-rank test|||Median change from baseline in MCS T-score at Week 24||||=0.001
72607500|NCT02668640|144743080|OTHER||||||<|0.0001|||||||Wilcoxon signed-rank test|||Median Change From Baseline in EQ-5D-3L Index Score at Week 12||||<0.0001
72607501|NCT02668640|144743080|OTHER||||||<|0.0001|||||||Wilcoxon signed-rank test|||Median Change From Baseline in EQ-5D-3L Index Score at Week 24||||<0.0001
72607502|NCT02668640|144743081|OTHER||||||=|0.0137|||||||Wilcoxon signed-rank test|||Median Change from Baseline in WPAI Overall Work Impairment Score at Week 12||||=0.0137
72607503|NCT02668640|144743081|OTHER||||||=|0.0607|||||||Wilcoxon signed-rank test|||Median Change from Baseline in Overall Work Impairment Score at Week 24||||=0.0607
72607504|NCT02668640|144743082|OTHER||||||=|0.0026|||||||Wilcoxon signed-rank test|||Median Change from Baseline in WPAI Activity Impairment Score at Week 12||||=0.0026
72607505|NCT02668640|144743082|OTHER||||||=|0.0001|||||||Wilcoxon signed-rank test|||Median Change from Baseline in WPAI Activity Impairment Score at Week 24||||=0.0001
72607506|NCT03246347|144743092|SUPERIORITY||Proportion|0.6111|||<|0.001|TWO_SIDED|95.0|0.4346|0.7686|||One-sided test for binomial proportions|||The 12-month PSA CR rate with ADT + docetaxel is 27.7% (Sweeney 2015); we estimated that the lower limit of the 95% CI was 23.4%. We sought to test the null hypothesis that the 52-week PSA CR rate for subjects treated with study therapy was \<=25%. We anticipated enrolling 39 subjects and this design would provide 90% power with a 1-sided alpha =0.10 significance level, assuming the true 52-week PSA CR rate was 45%. An improvement from 25% to 45% in 52-week PSA CR rate was considered important.||.7686|.4346|<0.001
72607507|NCT02674503|144743110|SUPERIORITY|||||||0.02||||||Linear fixed effect models adjusted for time in months|Regression, Linear|||||||0.02
72607508|NCT02674503|144743114|SUPERIORITY|||||||0.13|||||||Regression, Linear|Linear effects model adjusted for time (in months)||||||0.13
72607509|NCT02674503|144743116|SUPERIORITY|||||||0.02|||||||Regression, Linear|Linear mixed effects models adjusted for time (in months)||||||0.02
72607510|NCT03205150|144743175|SUPERIORITY||Mean Difference (Net)|-13.29|STANDARD_ERROR_OF_MEAN|7.35||0.075|TWO_SIDED|80.0|-22.8|-3.78|||ANCOVA|||||-3.78|-22.80|0.075
72607511|NCT03205150|144743175|SUPERIORITY||Mean Difference (Net)|-21.64|STANDARD_ERROR_OF_MEAN|7.49||0.005|TWO_SIDED|80.0|-31.33|-11.94|||ANCOVA|||||-11.94|-31.33|0.005
72607512|NCT03205150|144743175|SUPERIORITY||Mean Difference (Net)|8.35|STANDARD_ERROR_OF_MEAN|6.14||0.178|TWO_SIDED|80.0|0.41|16.29|||ANCOVA|||||16.29|0.41|0.178
72416853|NCT01506193|144344357|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority with respect to seroconversion rates for rubella was concluded if the lower limit of the 95% CI around the difference in seroconversion rates between groups would be \[-10%\] or higher.|Difference in percentage|0.0|||||TWO_SIDED|95.0|-1.23|2.29||||||"Immune response for anti-rubella antibodies~Non-inferiority of Priorix-Tetra™ vaccine co-administered with Meningitec® conjugate vaccine compared to the first dose of Priorix-Tetra™ vaccine alone with respect to anti-rubella seroconversion rates (SCRs) at Day 42 after dose 1."||2.29|-1.23|
72416854|NCT01506193|144344357|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority with respect to seroconversion rates for varicella was concluded if the lower limit of the 95% CI around the difference in seroconversion rates between groups would be \[-10%\] or higher.|Difference in percentage|-0.33|||||TWO_SIDED|95.0|-1.87|2.03||||||"Immune response for anti-varicella antibodies~Non-inferiority of Priorix-Tetra™ vaccine co-administered with Meningitec® conjugate vaccine compared to the first dose of Priorix-Tetra™ vaccine alone with respect to anti-varicella seroconversion rates (SCRs) at Day 42 after dose 1."||2.03|-1.87|
72416855|NCT01506193|144344358|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority with respect to seroresponse for rSBA-MenC was concluded if the lower limit of the 95% CI around the difference in seroprotection rates between groups would be \[-10%\] or higher.|Difference in percentage|-1.02|||||TWO_SIDED|95.0|-3.39|2.24||||||"Immune response for rSBA-MenC antibodies~Non-inferiority of Meningitec® conjugate vaccine co-administered with Priorix-Tetra™ compared to Meningitec® conjugate vaccine alone with respect to rabbit complement serum bactericidal assay (rSBA-MenC) antibody seroprotection rates (SPRs) at Day 42 after vaccination."||2.24|-3.39|
72416856|NCT02046980|144344367|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.39||||0.02839|TWO_SIDED|95.0|1.58|7.31|||Regression, Logistic|||||7.31|1.58|0.02839
72416857|NCT02046980|144344367|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.67||||0.0366|TWO_SIDED|95.0|1.25|5.67|||Regression, Logistic|||||5.67|1.25|0.0366
72607513|NCT03205150|144743176|SUPERIORITY||Mean Difference (Net)|-1.73|STANDARD_ERROR_OF_MEAN|1.45||0.235|TWO_SIDED|80.0|-3.6|0.14|||ANCOVA|||||0.14|-3.60|0.235
72607514|NCT03205150|144743176|SUPERIORITY||Mean Difference (Net)|-4.26|STANDARD_ERROR_OF_MEAN|1.46||0.004|TWO_SIDED|80.0|-6.14|-2.37|||ANCOVA|||||-2.37|-6.14|0.004
72607515|NCT03205150|144743176|SUPERIORITY||Mean Difference (Net)|2.52|STANDARD_ERROR_OF_MEAN|1.19||0.037|TWO_SIDED|80.0|0.98|4.07|||ANCOVA|||||4.07|0.98|0.037
72607516|NCT03205150|144743177|SUPERIORITY||Mean Difference (Net)|-3.15|STANDARD_ERROR_OF_MEAN|0.83|<|0.001|TWO_SIDED|80.0|-4.22|-2.08|||ANCOVA|||||-2.08|-4.22|<.001
72325185|NCT01214837|144173592|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI for the between group difference (MenACWY3 minus Routine) in percentage of subjects with IgG concentration ≥ 0.35 μg/mL against each pneumococcal anti-capsular polysaccharide is greater than -10%.|Vaccine group difference|-2.5|||||TWO_SIDED|95.0|-7.1|1.6|||Miettinen and Nurminen method|||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 2 doses of MenACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 7 months of age for Serotype 19A.||1.6|-7.1|
72325186|NCT01214837|144173592|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI for the between group difference (MenACWY4 minus Routine) in percentage of subjects with IgG concentration ≥ 0.35 μg/mL against each pneumococcal anti-capsular polysaccharide is greater than -10%.|Vaccine group difference|-5.5|||||TWO_SIDED|95.0|-11.3|-0.9|||Miettinen and Nurminen method|||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 3 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 7 months of age for Serotype 19A.||-0.9|-11.3|
72416858|NCT04575467|144344374|SUPERIORITY||Mean absolute fat thickness difference|-4.77|STANDARD_DEVIATION|2.29|<|0.01|TWO_SIDED|95.0|-7.17|-2.37|||Paired t-test|||||-2.37|-7.17|<0.01
72416859|NCT04575467|144344374|SUPERIORITY||Mean absolute fat thickness difference|-4.85|STANDARD_DEVIATION|2.02|<|0.01|TWO_SIDED|95.0|-6.97|-2.73|||Paired t-test|||||-2.73|-6.97|<0.01
72416860|NCT04575467|144344374|SUPERIORITY||Mean absolute fat thickness difference|-2.98|STANDARD_DEVIATION|2.83|<|0.05|TWO_SIDED|95.0|-5.95|-0.01|||Paired t-test|||||-0.01|-5.95|<0.05
72416861|NCT04575467|144344375|SUPERIORITY||Mean absolute fat volume difference|-114.4|STANDARD_DEVIATION|54.88|<|0.01|TWO_SIDED|95.0|-171.99|-56.81|||Paired t-test|||||-56.81|-171.99|<0.01
72607517|NCT03205150|144743177|SUPERIORITY||Mean Difference (Net)|-4.18|STANDARD_ERROR_OF_MEAN|0.85|<|0.001|TWO_SIDED|80.0|-5.28|-3.08|||ANCOVA|||||-3.08|-5.28|<.001
72607518|NCT03205150|144743177|SUPERIORITY||Mean Difference (Net)|1.03|STANDARD_ERROR_OF_MEAN|0.71||0.148|TWO_SIDED|80.0|0.12|1.94|||ANCOVA|||||1.94|0.12|0.148
72416862|NCT04575467|144344375|SUPERIORITY||Mean absolute fat volume difference|-155.2|STANDARD_DEVIATION|64.7|<|0.01|TWO_SIDED|95.0|-223.1|-87.3|||Paired t-test|||||-87.30|-223.10|<0.01
72416863|NCT04575467|144344375|SUPERIORITY||Mean absolute fat volume difference|-119.17|STANDARD_DEVIATION|113.11|<|0.05|TWO_SIDED|95.0|-237.86|-0.47|||Paired t-test|||||-0.47|-237.86|<0.05
72416864|NCT01483924|144344386|SUPERIORITY_OR_OTHER|||||||0.9048|TWO_SIDED||||||ANOVA|||The difference in change in PASI score from baseline to Week 12 was compared all active treatment groups and the placebo group||||0.9048
72416865|NCT01483924|144344387|SUPERIORITY_OR_OTHER|||||||0.1975|TWO_SIDED||||||Cochran-Armitage trend test|||||||0.1975
72416866|NCT01483924|144344388|SUPERIORITY_OR_OTHER|||||||0.6349|TWO_SIDED||||||Kruskal-Wallis|||||||0.6349
72416867|NCT01483924|144344389|SUPERIORITY_OR_OTHER|||||||0.6212|TWO_SIDED||||||Kruskal-Wallis|||||||0.6212
72421638|NCT03815019|144354429|SUPERIORITY||Odds Ratio, log|7.2218|STANDARD_ERROR_OF_MEAN|13083.0|||TWO_SIDED||||||||Participants in the megestrol group who successfully transitioned to oral feeding.|Analysis conducted using Generalized Linear Mixed Models with a logit link within SAS Proc GLIMMIX to model the binary outcome of transitioned to oral feeding (y/n) defined as at least 90 percent of calories consumed orally. Fixed effects (dummy variables) will be entered for each site as described by McNeish and Stapleton (2016) to account for the clustering of the participants within sites. This will result in essentially, a logistic regression model with appropriate standard errors.||||
72607519|NCT03205150|144743185|SUPERIORITY||Mean Difference (Net)|-11.15|STANDARD_ERROR_OF_MEAN|4.36||0.013|TWO_SIDED|80.0|-16.79|-5.5|||ANCOVA|||||-5.50|-16.79|0.013
72607520|NCT03205150|144743185|SUPERIORITY||Mean Difference (Net)|-14.71|STANDARD_ERROR_OF_MEAN|4.43||0.001|TWO_SIDED|80.0|-20.43|-8.98|||ANCOVA|||||-8.98|-20.43|0.001
72416868|NCT03565887|144344409|SUPERIORITY|The primary efficacy endpoints were tested sequentially. The Day 1 Hour 6 time point was tested first and if P\<0.05, the Day 14 Hour 2 time point was tested at a significance level of 0.05. If the Day 1 Hour 6 endpoint is statistically significant (at the 0.05 level) but Day 14 Hour 2 was not statistically significant (at the 0.05 level), the study will still be considered positive.|||||<|0.0001||||||If both primary endpoints (LPFT) are significant at 0.05 significance level, then the secondary efficacy endpoints (MRD) were also tested sequentially. Testing stopped if a P≥ 0.05 for a comparison.|ANCOVA|2 sided t-test with treatment as fixed factor and baseline as covariate.||A two group t-test with a 0.05 two-sided significance level had 90% power to detect a difference in LPFT means of 3.50 assuming that the common standard deviation was 6.0, when the sample sizes in the 2 groups were 94 and 47, respectively (a total sample size of 141).||||<0.0001
72416869|NCT03565887|144344410|SUPERIORITY|If both primary endpoints (LPFT) are significant at 0.05 significance level, then the secondary efficacy endpoints (MRD) were also tested sequentially. Testing stopped if a P≥ 0.05 for a comparison.|||||<|0.0151|||||||ANCOVA|||A two group t-test with a 0.05 two-sided significance level had 90% power to detect a difference in LPFT means of 3.50 assuming that the common standard deviation was 6.0, when the sample sizes in the 2 groups were 94 and 47, respectively (a total sample size of 141).||||<0.0151
72416870|NCT01994954|144344411|SUPERIORITY||||||<|0.03||||||A two-sided P-value of 0.05 or less was interpreted as a statistically significant result.|t-test, 2 sided|||The trial was designed to have 97% power at a type I error rate of 5% to detect a 25% intervention effect with respect to the primary outcome. this was done using an independent sample t-test. P-value was calculated, and a p-value of 0.05 or less was interpreted as statistically significant result.||||<0.03
72416871|NCT01994954|144344412|SUPERIORITY|||||||0.38|||||||Wilcoxon (Mann-Whitney)|||Power calculations were based on the primary analysis (t-test comparing changes). A sample size of 130 would have given 80% power, with 0.05 two sided type 1 error rate, to detect a 20% absolute difference in emotional role limitation on the PedsQL v2.0, which we considered to be statistically significant.||||0.38
72607521|NCT03205150|144743185|SUPERIORITY||Mean Difference (Net)|3.56|STANDARD_ERROR_OF_MEAN|3.65||0.332|TWO_SIDED|80.0|-1.15|8.28|||ANCOVA|||||8.28|-1.15|0.332
72607522|NCT00871624|144743186|NON_INFERIORITY_OR_EQUIVALENCE|A difference in the mean four-point NIV intolerance score of 1 over the course of the study or between groups was considered through investigator consensus to be clinically meaningful. Assuming that the SD of NIV intolerance scores was 1 and that an alpha of 0.05 would be used for testing, it was determined that 18 subjects were needed in each group to achieve an 80% power.|Odds Ratio (OR)|1.44||||0.54|TWO_SIDED|95.0|0.44|4.7|||Chi-squared|||||4.7|0.44|0.54
72607523|NCT00871624|144743187|OTHER|||||||0.3|||||||Chi-squared|||||||0.3
72607524|NCT00789321|144743197|SUPERIORITY_OR_OTHER||Least Squares Mean|-11.7||||0.001||90.0|-18.1|-5.4|||ANCOVA|Change from baseline in systolic blood pressure included as covariate||||-5.4|-18.1|0.001
72607525|NCT00789321|144743198|SUPERIORITY_OR_OTHER||Least Squares Mean|39.0||||0.001||95.0|17.9|60.1|||ANCOVA|Change from baseline in systolic blood pressure included as covariate||||60.1|17.9|0.001
72607526|NCT00830219|144743199|NON_INFERIORITY_OR_EQUIVALENCE|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|103.53||||||90.0|99.16|108.09|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||108.09|99.16|
72607527|NCT00830219|144743200|NON_INFERIORITY_OR_EQUIVALENCE|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|102.3||||||90.0|97.56|107.27|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||107.27|97.56|
72607528|NCT00830219|144743201|NON_INFERIORITY_OR_EQUIVALENCE|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|102.54||||||90.0|97.53|107.8|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||107.8|97.53|
72607529|NCT01294423|144743202|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.35|STANDARD_ERROR_OF_MEAN|0.0853|<|0.0001|TWO_SIDED|95.0|-0.52|-0.18||significant at alpha=0.027 (2-sided) applying Dunnett's adjustment. A hierarchical closed testing procedure was used to control the Type I error rate across the primary and key secondary endpoints.|ANCOVA|with treatment group (all treatment groups included) and gender as effect and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0 (with alpha = 0.027 applying Dunnett's adjustment, two-sided)||-0.18|-0.52|<0.0001
72416872|NCT00449176|144344416|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8|STANDARD_ERROR_OF_MEAN|0.19|<|0.001||95.0|-1.22|-0.47|||ANCOVA|||The primary null hypothesis to be tested for the study was that the tapentadol ER group was not different from the placebo group for the primary endpoint. Assuming the mean treatment group difference of 0.7 with an SD of 2.7, 314 subjects per treatment group were estimated to provide 90% power to show that the tapentadol ER group was statistically different from placebo at an alpha level of 0.05. The total number of subjects to be randomly assigned to a treatment group for the study was 942.||-0.47|-1.22|<0.001
72416873|NCT02363946|144344533|OTHER||alpha estimate|9.557|STANDARD_ERROR_OF_MEAN|0.037|||TWO_SIDED||||||||Estimation of model: Parameter = alpha \* Dose\^beta. Determined from linear regression model: Log(Parameter) = log(Dose)|Dose-Proportionality of Pharmacokinetic Parameter Cmax for Analyte AD00370||||
72416874|NCT02363946|144344533|OTHER||beta estimate|1.173|STANDARD_ERROR_OF_MEAN|0.027|||TWO_SIDED|95.0|1.128|1.218|||||Estimation of model: Parameter = alpha \* Dose\^beta. Determined from linear regression model: Log(Parameter) = log(Dose)|Dose-Proportionality of Pharmacokinetic Parameter Cmax for Analyte AD00370|R-square (r\^2)=0.98|1.218|1.128|
72416875|NCT02363946|144344533|OTHER||alpha estimate|9.824|STANDARD_ERROR_OF_MEAN|0.03|||TWO_SIDED||||||||Estimation of model: Parameter = alpha \* Dose\^beta. Determined from linear regression model: Log(Parameter) = log(Dose)|Dose-Proportionality of Pharmacokinetic Parameter Cmax for Analyte ARC-MLP||||
72325187|NCT01214837|144173592|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI for the between group difference (MenACWY3 minus Routine) in percentage of subjects with IgG concentration ≥ 0.35 μg/mL against each pneumococcal anti-capsular polysaccharide is greater than -10%.|Vaccine group difference|0.6|||||TWO_SIDED|95.0|-1.7|3.4|||Miettinen and Nurminen method|||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 2 doses of MenACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 7 months of age for Serotype 19F.||3.4|-1.7|
72325188|NCT01214837|144173592|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI for the between group difference (MenACWY4 minus Routine) in percentage of subjects with IgG concentration ≥ 0.35 μg/mL against each pneumococcal anti-capsular polysaccharide is greater than -10%.|Vaccine group difference|0.6|||||TWO_SIDED|95.0|-2.1|3.4|||Miettinen and Nurminen method|||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 3 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 7 months of age for Serotype 19F.||3.4|-2.1|
72325189|NCT01214837|144173592|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI for the between group difference (MenACWY3 minus Routine) in percentage of subjects with IgG concentration ≥ 0.35 μg/mL against each pneumococcal anti-capsular polysaccharide is greater than -10%.|Vaccine group difference|1.9|||||TWO_SIDED|95.0|-4.2|8.2|||Miettinen and Nurminen method|||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 2 doses of MenACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 7 months of age for Serotype 23F.||8.2|-4.2|
72325190|NCT01214837|144173592|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI for the between group difference (MenACWY4 minus Routine) in percentage of subjects with IgG concentration ≥ 0.35 μg/mL against each pneumococcal anti-capsular polysaccharide is greater than -10%.|Vaccine group difference|4.5|||||TWO_SIDED|95.0|-1.4|10.5|||Miettinen and Nurminen method|||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 3 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 7 months of age for Serotype 23F.||10.5|-1.4|
72325191|NCT01214837|144173593|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI around the ratio of GMCs between groups (MenACWY3 to routine vaccines) is greater than 0.5.|GMC ratio|0.94|||||TWO_SIDED|95.0|0.77|1.13|||ANOVA|||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 3 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 13 months of age for Serotype 1.||1.13|0.77|
72325192|NCT01214837|144173593|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI around the ratio of GMCs between the groups (MenACWY4 to routine vaccines) is greater than 0.5.|GMC ratio|1.02|||||TWO_SIDED|95.0|0.83|1.25|||ANOVA|||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 4 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 13 months of age for Serotype 1.||1.25|0.83|
72325193|NCT01214837|144173593|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI around the ratio of GMCs between groups (MenACWY3 to routine vaccines) is greater than 0.5.|GMC ratio|1.14|||||TWO_SIDED|95.0|0.93|1.4|||ANOVA|||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 3 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 13 months of age for Serotype 3.||1.4|0.93|
72325194|NCT01214837|144173593|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI around the ratio of GMCs between the groups (MenACWY4 to routine vaccines) is greater than 0.5.|GMC ratio|1.25|||||TWO_SIDED|95.0|1.01|1.55|||ANOVA|||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 4 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 13 months of age for Serotype 3.||1.55|1.01|
72325195|NCT01214837|144173593|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI around the ratio of GMCs between groups (MenACWY3 to routine vaccines) is greater than 0.5.|GMC ratio|0.77|||||TWO_SIDED|95.0|0.62|0.96|||ANOVA|||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 3 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 13 months of age for Serotype 4.||0.96|0.62|
72416876|NCT02363946|144344533|OTHER||beta estimate|1.103|STANDARD_ERROR_OF_MEAN|0.029|||TWO_SIDED|95.0|1.054|1.153|||||Estimation of model: Parameter = alpha \* Dose\^beta. Determined from linear regression model: Log(Parameter) = log(Dose)|Dose-Proportionality of Pharmacokinetic Parameter Cmax for Analyte ARC-MLP|R-square (r\^2)=0.98|1.153|1.054|
72325196|NCT01214837|144173593|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI around the ratio of GMCs between the groups (MenACWY4 to routine vaccines) is greater than 0.5.|GMC ratio|0.94|||||TWO_SIDED|95.0|0.75|1.18|||ANOVA|||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 4 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 13 months of age for Serotype 4.||1.18|0.75|
72325197|NCT01214837|144173593|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI around the ratio of GMCs between groups (MenACWY3 to routine vaccines) is greater than 0.5.|GMC ratio|1.02|||||TWO_SIDED|95.0|0.86|1.21|||ANOVA|||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 3 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 13 months of age for Serotype 5.||1.21|0.86|
72325198|NCT01214837|144173593|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI around the ratio of GMCs between the groups (MenACWY4 to routine vaccines) is greater than 0.5|GMC ratio|1.07|||||TWO_SIDED|95.0|0.89|1.29|||ANOVA|||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 4 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 13 months of age for Serotype 5.||1.29|0.89|
72416877|NCT02363946|144344535|OTHER||alpha estimate|11.274|STANDARD_ERROR_OF_MEAN|0.057|||TWO_SIDED||||||||Estimation of model: Parameter = alpha \* Dose\^beta. Determined from linear regression model: Log(Parameter) = log(Dose)|Dose-Proportionality of Pharmacokinetic Parameter AUC0-24 for Analyte AD00370||||
72416878|NCT02363946|144344535|OTHER||beta estimate|1.181|STANDARD_ERROR_OF_MEAN|0.04|||TWO_SIDED|95.0|1.112|1.249|||||Estimation of model: Parameter = alpha \* Dose\^beta. Determined from linear regression model: Log(Parameter) = log(Dose)|Dose-Proportionality of Pharmacokinetic Parameter AUC0-24 for Analyte AD00370|R-square (r\^2)=0.96|1.249|1.112|
72416879|NCT02363946|144344535|OTHER||alpha estimate|12.133|STANDARD_ERROR_OF_MEAN|0.04|||TWO_SIDED||||||||Estimation of model: Parameter = alpha \* Dose\^beta. Determined from linear regression model: Log(Parameter) = log(Dose)|Dose-Proportionality of Pharmacokinetic Parameter AUC0-24 for Analyte ARC-MLP||||
72416880|NCT02363946|144344535|OTHER||beta estimate|1.147|STANDARD_ERROR_OF_MEAN|0.04|||TWO_SIDED|95.0|1.08|1.215|||||Estimation of model: Parameter = alpha \* Dose\^beta. Determined from linear regression model: Log(Parameter) = log(Dose)|Dose-Proportionality of Pharmacokinetic Parameter AUC0-24 for Analyte ARC-MLP|R-square (r\^2)=0.96|1.215|1.080|
72416881|NCT02363946|144344536|OTHER||alpha estimate|11.286|STANDARD_ERROR_OF_MEAN|0.058|||TWO_SIDED||||||||Estimation of model: Parameter = alpha \* Dose\^beta. Determined from linear regression model: Log(Parameter) = log(Dose)|Dose-Proportionality of Pharmacokinetic Parameter AUCinf for Analyte AD00370||||
72607530|NCT01294423|144743202|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.39|STANDARD_ERROR_OF_MEAN|0.0851|<|0.0001|TWO_SIDED|95.0|-0.56|-0.23||significant at alpha=0.027 (2-sided) applying Dunnett's adjustment. A hierarchical closed testing procedure was used to control the Type I error rate across the primary and key secondary endpoints.|ANCOVA|with treatment group (all treatment groups included) and gender as effect and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0 (with alpha = 0.027 applying Dunnett's adjustment, two-sided)||-0.23|-0.56|<0.0001
72607531|NCT01294423|144743203|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.4|STANDARD_ERROR_OF_MEAN|2.902|<|0.0001|TWO_SIDED|95.0|-20.1|-8.7||significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure within treatment group.|ANCOVA|with treatment group (all treatment groups included) and stratum (HbA1c at randomization by gender) as effect and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0||-8.7|-20.1|<0.0001
72607532|NCT01294423|144743203|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.5|STANDARD_ERROR_OF_MEAN|2.892|<|0.0001|TWO_SIDED|95.0|-25.2|-13.8||significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure within treatment group.|ANCOVA|with treatment group (all treatment groups included) and stratum (HbA1c at randomization by gender) as effect and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0||-13.8|-25.2|<0.0001
72325199|NCT01214837|144173593|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI around the ratio of GMCs between groups (MenACWY3 to routine vaccines) is greater than 0.5.|GMC ratio|0.85|||||TWO_SIDED|95.0|0.69|1.04|||ANOVA|||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 3 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 13 months of age for Serotype 6A.||1.04|0.69|
72416882|NCT02363946|144344536|OTHER||beta estimate|1.179|STANDARD_ERROR_OF_MEAN|0.041|||TWO_SIDED|95.0|1.11|1.249|||||Estimation of model: Parameter = alpha \* Dose\^beta. Determined from linear regression model: Log(Parameter) = log(Dose)|Dose-Proportionality of Pharmacokinetic Parameter AUCinf for Analyte AD00370|R-square (r\^2)=0.96|1.249|1.110|
72416883|NCT02363946|144344536|OTHER||alpha estimate|12.347|STANDARD_ERROR_OF_MEAN|0.049|||TWO_SIDED||||||||Estimation of model: Parameter = alpha \* Dose\^beta. Determined from linear regression model: Log(Parameter) = log(Dose)|Dose-Proportionality of Pharmacokinetic Parameter AUCinf for Analyte ARC-MLP||||
72416884|NCT02363946|144344536|OTHER||beta estimate|1.163|STANDARD_ERROR_OF_MEAN|0.049|||TWO_SIDED|95.0|1.081|1.245|||||Estimation of model: Parameter = alpha \* Dose\^beta. Determined from linear regression model: Log(Parameter) = log(Dose)|Dose-Proportionality of Pharmacokinetic Parameter AUCinf for Analyte ARC-MLP|R-square (r\^2)=0.95|1.245|1.081|
72416885|NCT01967732|144344545|SUPERIORITY_OR_OTHER_LEGACY||Geometric LS Mean Ratio|77.43|||||TWO_SIDED|95.0|62.69|95.63|||ANOVA|The model included terms for sequence, subject nested within sequence, period, and product as fixed effect factors.|LS mean ratio (THS 2.2 - Group 1:CC - Group 1)|The objective of this study was to determine the point estimate and precision of the nicotine bioavailability (ratio of THS 2.2:CC) for Cmax, therefore, there was no statistical hypothesis to be tested for this objective.||95.63|62.69|
72416886|NCT01967732|144344546|SUPERIORITY_OR_OTHER_LEGACY||Geometric LS Mean Ratio|74.47|||||TWO_SIDED|95.0|61.52|90.14|||ANOVA|The model included terms for sequence, subject nested within sequence, period, and product as fixed effect factors.|LS mean ratio (THS 2.2 - Group 1:CC - Group 1)|The objective of this study was to determine the point estimate and precision of the nicotine bioavailability (ratio of THS 2.2:CC) for AUC(0-last), therefore, there was no statistical hypothesis to be tested for this objective.||90.14|61.52|
72416887|NCT01292239|144344570|SUPERIORITY_OR_OTHER||(see comment)|27.5|||<|0.0001|TWO_SIDED|95.0|14.38|40.56||The p-value was based on the asymptomatic distribution of the generalized Cochran-Mantel-Haenszel (CMH) statistic controlling for stratification factors.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was adjusted for stratification factors (age and IL28B genotype).|The parameter estimated was the difference of stratum adjusted proportion between groups.|||40.56|14.38|<0.0001
72416888|NCT01292239|144344571|SUPERIORITY_OR_OTHER||(see comment)|32.6|||<|0.0001|TWO_SIDED|95.0|19.75|45.4||The p-value was based on the asymptomatic distribution of the generalized Cochran-Mantel-Haenszel (CMH) statistic controlling for stratification factors.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was adjusted for stratification factors (age and IL28B genotype).|The parameter estimated was the difference of stratum adjusted proportion between groups.|||45.40|19.75|<0.0001
72416889|NCT01988779|144344585|NON_INFERIORITY|Assuming that the non-inferiority limit of topical therapy is 20% of that for oral therapy.||||||0.505|||||||ANOVA|||||||0.505
72416890|NCT01988779|144344587|NON_INFERIORITY|Assuming that the non-inferiority limit of topical therapy is 20% of that for oral therapy.||||||0.39|||||||ANOVA|||||||0.390
72416891|NCT01988779|144344588|NON_INFERIORITY|Assuming that the non-inferiority limit of topical therapy is 20% of that for oral therapy.||||||0.036|||||||ANOVA|||||||0.036
72416892|NCT00377403|144344592|SUPERIORITY_OR_OTHER|||||||0.83||95.0||||The a priori threshold for statistical significnace was p less than or equal to 0.05|ANOVA|Adjusted for disease severity at baseline||We used analysis of variance, controlling for disease severity at baseline to test the null hypothesis that there was no difference between study groups at this point in time.||||0.83
72607533|NCT01294423|144743204|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.29|STANDARD_ERROR_OF_MEAN|0.3533||0.0003|TWO_SIDED|95.0|-1.98|-0.59||significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure within treatment group.|ANCOVA|with treatment group (all treatment groups included) and stratum (HbA1c at randomization by gender) as effect and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0||-0.59|-1.98|0.0003
72607534|NCT01294423|144743204|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.38|STANDARD_ERROR_OF_MEAN|0.354||0.0001|TWO_SIDED|95.0|-2.08|-0.69||significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure within treatment group.|ANCOVA|with treatment group (all treatment groups included) and stratum (HbA1c at randomization by gender) as effect and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0||-0.69|-2.08|0.0001
72416893|NCT00736645|144344593|OTHER|||||||0.5137|||||||Wilcoxon (Mann-Whitney)|||||||0.5137
72416894|NCT00736645|144344593|OTHER|||||||0.8994|||||||Wilcoxon (Mann-Whitney)|||||||0.8994
72416895|NCT00736645|144344593|OTHER|||||||0.3463|||||||Wilcoxon (Mann-Whitney)|||||||0.3463
72416896|NCT00736645|144344594|OTHER|||||||0.2609|||||||Wilcoxon (Mann-Whitney)|||||||0.2609
72416897|NCT00736645|144344594|OTHER|||||||0.7504|||||||Wilcoxon (Mann-Whitney)|||||||0.7504
72416898|NCT00736645|144344594|OTHER|||||||0.9727|||||||Wilcoxon (Mann-Whitney)|||||||0.9727
72416899|NCT00295022|144344605|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.12|||<|0.001|TWO_SIDED|95.0|-4.35|-1.88|||ANCOVA|||||-1.88|-4.35|<0.001
72416900|NCT00295022|144344605|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.93|||=|0.001|TWO_SIDED|95.0|-2.04|0.18|||ANCOVA|||||0.18|-2.04|=0.001
72416901|NCT00295022|144344605|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-2.19|||<|0.001|TWO_SIDED|95.0|-3.43|-0.95|||ANCOVA|||||-0.95|-3.43|<0.001
72416902|NCT02238379|144344638|SUPERIORITY_OR_OTHER|||||||0.003||||||Main Effect of Emotion|ANOVA|Spray (Oxytocin, Placebo) by Face Type (Infant, Adult) by Emotion (Distress, Neutral) by Hemisphere (Left, Right) ANOVA||N170 Analysis||||.003
72416903|NCT02238379|144344638|SUPERIORITY_OR_OTHER|||||||0.034||||||Main Effect of Face Type|ANOVA|Spray (Oxytocin, Placebo) by Face Type (Infant, Adult) by Emotion (Distress, Neutral) by Hemisphere (Left, Right) ANOVA||N170 Analysis||||.034
72416904|NCT02238379|144344638|SUPERIORITY_OR_OTHER|||||||0.03||||||Main Effect of Face Type|ANOVA|Spray Type (Oxytocin, Placebo) by Face Type (Infant, Adult) by Emotion (Distress, Neutral) ANOVA||P300 Analysis||||.03
72416905|NCT02238379|144344638|SUPERIORITY_OR_OTHER|||||||0.03||||||Spray Type by Face Type Interaction|ANOVA|Spray Type (Oxytocin, Placebo) by Face Type (Infant, Adult) by Emotion (Distress, Neutral) ANOVA||P300 Analysis||||.03
72416906|NCT02238379|144344638|SUPERIORITY_OR_OTHER||||||>|0.22||||||No Main Effects or Interactions|ANOVA|Spray Type (Oxytocin, Placebo) by Face Type (Infant, Adult) by Emotion (Distress, Neutral) ANOVA||LPP Analysis||||>.22
72416907|NCT02238379|144344639|SUPERIORITY_OR_OTHER||||||>|0.14||||||No Main Effects or Interactions|ANOVA|Spray Type (Oxytocin, Placebo) and Hemisphere (left, right) ANOVA||N170 Analysis||||>.14
72416908|NCT02238379|144344639|SUPERIORITY_OR_OTHER||||||>|0.17||||||No difference between Spray Types|t-test, 2 sided|Paired samples t-test comparing Spray Type (Oxytocin vs Placebo)||P300 Analysis||||>.17
72416909|NCT02238379|144344639|SUPERIORITY_OR_OTHER||||||>|0.27||||||No difference between Spray Types|t-test, 2 sided|Paired samples t-test comparing Spray Type (Oxytocin vs Placebo)||LPP Analysis||||>.27
72416910|NCT02238379|144344640|SUPERIORITY_OR_OTHER|||||||0.006||||||Main Effect of Emotion|ANOVA|Spray Type (Oxytocin, Placebo), Face Type (Infant, Adult), Emotion (Neutral, Distressed), and Hemisphere (left, right) ANOVA||Only relevant for N170||||.006
72416911|NCT02238379|144344640|SUPERIORITY_OR_OTHER|||||||0.01||||||Main Effect of Hemisphere|ANOVA|Spray Type (Oxytocin, Placebo), Face Type (Infant, Adult), Emotion (Neutral, Distressed), and Hemisphere (left, right) ANOVA||Only relevant for N170||||.01
72607535|NCT02026141|144743228|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||ANCOVA|||||||<0.05
72325200|NCT01214837|144173593|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI around the ratio of GMCs between the groups (MenACWY4 to routine vaccines) is greater than 0.5.|GMC ratio|1.1|||||TWO_SIDED|95.0|0.88|1.37|||ANOVA|||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 4 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 13 months of age for Serotype 6A.||1.37|0.88|
72607536|NCT01240382|144743307|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority in mean change in fluorescein staining score from baseline was assessed on the non-inferiority margin (0.34) with the upper limit of the confidence interval of the difference between the 2 treatment groups.|Median Difference (Final Values)|-0.03||||||95.0|-0.405|0.338|||l|||||0.338|-0.405|
72607537|NCT01240382|144743308|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.67||||0.01||95.0|-1.18|-0.67|||t-test, 2 sided|||||-0.67|-1.18|0.010
72607538|NCT02456727|144743312|SUPERIORITY||Mean Difference (Net)|-0.3714|STANDARD_ERROR_OF_MEAN|0.2039||0.0691|TWO_SIDED|95.0|-0.772|0.0291|||ANCOVA|The outcome is the change of score from baseline to 12 weeks, adjusting for the baseline score.|The estimated value is the difference of score change from baseline to 12 weeks between two treatment arms (Individual-Group).|||0.0291|-0.7720|0.0691
72607539|NCT02456727|144743313|SUPERIORITY||Mean Difference (Net)|-0.1631|STANDARD_ERROR_OF_MEAN|0.246||0.5077|TWO_SIDED|95.0|-0.6452|0.319|||ANCOVA|The outcome is the change of score from baseline to 12 weeks, adjusting for the baseline score.|The estimated value is the difference of score change from baseline to 12 weeks between two treatment arms (Individual-Group).|||0.319|-0.6452|0.5077
72607540|NCT02456727|144743314|NON_INFERIORITY|The null hypothesis is that the group treatment is inferior to the individual treatment. 10% is set as the non-inferiority margin. If the upper limit of 90% confidence interval of the estimated value does not exceed 10%, non-inferiority is demonstrated.|Risk Difference (RD)|0.0724|STANDARD_ERROR_OF_MEAN|0.0399||0.24|TWO_SIDED|95.0|-0.0058|0.1506|||Chi-squared||The estimated value is the difference of proportion of respondents (\>=30% improvement) at 12 weeks between two treatment arms (Individual-Group)|||0.1506|-0.0058|0.24
72607541|NCT02456727|144743315|NON_INFERIORITY|The null hypothesis is that the group treatment is inferior to the individual treatment. 10% is set as the non-inferiority margin. If the upper limit of 90% confidence interval of the estimated value does not exceed 10%, non-inferiority is demonstrated.|Risk Difference (RD)|0.0531|STANDARD_ERROR_OF_MEAN|0.0487||0.17|TWO_SIDED|95.0|-0.0422|0.1485|||Chi-squared||The estimated value is the difference of proportion of respondents (\>=30% improvement) at 12 weeks between two treatment arms (Individual-Group)|||0.1485|-0.0422|0.17
72607542|NCT02456727|144743316|NON_INFERIORITY|The null hypothesis is that the group treatment is inferior to the individual treatment. 10% is set as the non-inferiority margin. If the upper limit of 90% confidence interval of the estimated value does not exceed 10%, non-inferiority is demonstrated.|Risk Difference (RD)|0.0625|STANDARD_ERROR_OF_MEAN|0.0396||0.17|TWO_SIDED|95.0|-0.0151|0.1401|||Chi-squared||The estimated value is the difference of proportion of respondents (\>=30% improvement) at 24 weeks between two treatment arms (Individual-Group)|||0.1401|-0.0151|0.17
72607543|NCT02456727|144743317|NON_INFERIORITY|The null hypothesis is that the group treatment is inferior to the individual treatment. 10% is set as the non-inferiority margin. If the upper limit of 90% confidence interval of the estimated value does not exceed 10%, non-inferiority is demonstrated.|Risk Difference (RD)|0.0882|STANDARD_ERROR_OF_MEAN|0.0488||0.4|TWO_SIDED|95.0|-0.0075|0.184|||Chi-squared||The estimated value is the difference of proportion of respondents (\>=30% improvement) at 24 weeks between two treatment arms (Individual-Group)|||0.184|-0.0075|0.40
72607544|NCT02456727|144743318|SUPERIORITY||Mean Difference (Net)|-0.2643|STANDARD_ERROR_OF_MEAN|0.1782||0.1387|TWO_SIDED|95.0|-0.6136|0.0851|||ANCOVA|The outcome is the change in score from baseline to 12 weeks, adjusting for the baseline score.|The estimated value is the difference of score change from baseline to 12 weeks between the two treatment arms (Individual-Group).|||0.0851|-0.6136|0.1387
72607545|NCT02456727|144743319|SUPERIORITY||Mean Difference (Net)|-0.2334|STANDARD_ERROR_OF_MEAN|0.2124||0.2725|TWO_SIDED|95.0|-0.6497|0.1829|||ANCOVA|The outcome is the change in score from baseline to 12 weeks, adjusting for the baseline score.|The estimated value is the difference of score change from baseline to 12 weeks between the two treatment arms (Individual-Group).|||0.1829|-0.6497|0.2725
72416912|NCT02238379|144344641|SUPERIORITY_OR_OTHER|||||||0.03||||||Main Effect of Spray|ANOVA|Spray (oxytocin, placebo) by Hemisphere (left, right) ANOVA||Only relevant for N170||||.03
72416913|NCT02238379|144344641|SUPERIORITY_OR_OTHER|||||||0.008||||||Main Effect of Hemisphere|ANOVA|Spray (oxytocin, placebo) by Hemisphere (left, right) ANOVA||Only relevant for N170||||.008
72416914|NCT02238379|144344642|SUPERIORITY_OR_OTHER|||||||0.05|||||||correlation|||||||.05
72416915|NCT02238379|144344644|SUPERIORITY_OR_OTHER|||||||0.05|||||||correlation|||||||.05
72416916|NCT02238379|144344645|SUPERIORITY_OR_OTHER|||||||0.05|||||||correlation|||||||.05
72416917|NCT02238379|144344646|SUPERIORITY_OR_OTHER|||||||0.05|||||||correlation|||||||.05
72416918|NCT00518115|144344674|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2||||0.2968|TWO_SIDED|95.0|-0.18|0.59|||ANCOVA|||||0.59|-0.18|0.2968
72607546|NCT02456727|144743320|NON_INFERIORITY|The null hypothesis is that the group treatment is inferior to the individual treatment. 10% is set as the non-inferiority margin. If the upper limit of 90% confidence interval of the estimated value does not exceed 10%, non-inferiority is demonstrated.|Risk Difference (RD)|0.0426|STANDARD_ERROR_OF_MEAN|0.0388||0.07|TWO_SIDED|95.0|-0.0334|0.1185|||Chi-squared||The estimated value is the difference of proportion of respondents (\>=30% improvement) at 12 weeks between two treatment arms (Individual-Group)|||0.1185|-0.0334|0.07
72607547|NCT02456727|144743321|NON_INFERIORITY|The null hypothesis is that the group treatment is inferior to the individual treatment. 10% is set as the non-inferiority margin. If the upper limit of 90% confidence interval of the estimated value does not exceed 10%, non-inferiority is demonstrated.|Risk Difference (RD)|0.0283|STANDARD_ERROR_OF_MEAN|0.0477||0.07|TWO_SIDED|95.0|-0.0651|0.1218|||Chi-squared||The estimated value is the difference of proportion of respondents (\>=30% improvement) at 12 weeks between two treatment arms (Individual-Group)|||0.1218|-0.0651|0.07
72607548|NCT02456727|144743322|NON_INFERIORITY|The null hypothesis is that the group treatment is inferior to the individual treatment. 10% is set as the non-inferiority margin. If the upper limit of 90% confidence interval of the estimated value does not exceed 10%, non-inferiority is demonstrated.|Risk Difference (RD)|0.0262|STANDARD_ERROR_OF_MEAN|0.0356||0.02|TWO_SIDED|95.0|-0.0436|0.0961|||Chi-squared||The estimated value is the difference of proportion of respondents (\>=30% improvement) at 24 weeks between two treatment arms (Individual-Group)|||0.0961|-0.0436|0.02
72607549|NCT02456727|144743323|NON_INFERIORITY|The null hypothesis is that the group treatment is inferior to the individual treatment. 10% is set as the non-inferiority margin. If the upper limit of 90% confidence interval of the estimated value does not exceed 10%, non-inferiority is demonstrated.|Risk Difference (RD)|0.0323|STANDARD_ERROR_OF_MEAN|0.044||0.06|TWO_SIDED|95.0|-0.0539|0.1186|||Chi-squared||The estimated value is the difference of proportion of respondents (\>=30% improvement) at 24 weeks between two treatment arms (Individual-Group)|||0.1186|-0.0539|0.06
72607550|NCT02456727|144743324|SUPERIORITY||Mean Difference (Net)|-0.22|STANDARD_ERROR_OF_MEAN|0.15||0.1475|TWO_SIDED|95.0|-0.5288|0.0795|||t-test, 2 sided|The outcome is the change of PGIC from baseline to 12 weeks.|The estimated value is the difference of PGIC change from baseline to 12 weeks between two treatment arms (Individual-Group).|||0.0795|-0.5288|0.1475
72607551|NCT02456727|144743325|SUPERIORITY||Mean Difference (Net)|-0.19|STANDARD_ERROR_OF_MEAN|0.18||0.3038|TWO_SIDED|95.0|-0.546|0.1706|||t-test, 2 sided|The outcome is the change of PGIC from baseline to 12 weeks.|The estimated value is the difference of PGIC change from baseline to 12 weeks between two treatment arms (Individual-Group).|||0.1706|-0.546|0.3038
72607552|NCT02456727|144743326|NON_INFERIORITY|The null hypothesis is that the group treatment is inferior to the individual treatment. 10% is set as the non-inferiority margin. If the upper limit of 90% confidence interval of the estimated value does not exceed 10%, non-inferiority is demonstrated.|Risk Difference (RD)|0.0251|STANDARD_ERROR_OF_MEAN|0.0392||0.03|TWO_SIDED|95.0|-0.0517|0.1018|||Chi-squared||The estimated value is the difference of proportion of respondents (change post treatment\>=6) at 12 weeks between two treatment arms (Individual-Group)|||0.1018|-0.0517|0.03
72607553|NCT02456727|144743327|NON_INFERIORITY|The null hypothesis is that the group treatment is inferior to the individual treatment. 10% is set as the non-inferiority margin. If the upper limit of 90% confidence interval of the estimated value does not exceed 10%, non-inferiority is demonstrated.|Risk Difference (RD)|0.0018|STANDARD_ERROR_OF_MEAN|0.0481||0.02|TWO_SIDED|95.0|-0.0925|0.096|||Chi-squared||The estimated value is the difference of proportion of respondents (change post treatment\>=6) at 12 weeks between two treatment arms (Individual-Group)|||0.096|-0.0925|0.02
72607554|NCT02456727|144743328|NON_INFERIORITY|The null hypothesis is that the group treatment is inferior to the individual treatment. 10% is set as the non-inferiority margin. If the upper limit of 90% confidence interval of the estimated value does not exceed 10%, non-inferiority is demonstrated.|Risk Difference (RD)|-0.0104|STANDARD_ERROR_OF_MEAN|0.036||0|TWO_SIDED|95.0|-0.081|0.0602|||Chi-squared||The estimated value is the difference of proportion of respondents (change post treatment\>=6) at 24 weeks between two treatment arms (Individual-Group)|||0.0602|-0.081|0.00
72607555|NCT02456727|144743329|NON_INFERIORITY|The null hypothesis is that the group treatment is inferior to the individual treatment. 10% is set as the non-inferiority margin. If the upper limit of 90% confidence interval of the estimated value does not exceed 10%, non-inferiority is demonstrated.|Risk Difference (RD)|0.0154|STANDARD_ERROR_OF_MEAN|0.0464||0.03|TWO_SIDED|95.0|-0.0755|0.1063|||Chi-squared||The estimated value is the difference of proportion of respondents (change post treatment\>=6) at 24 weeks between two treatment arms (Individual-Group)|||0.1063|-0.0755|0.03
72607556|NCT02456727|144743330|SUPERIORITY||Mean Difference (Net)|0.082|STANDARD_ERROR_OF_MEAN|0.5336||0.8778|TWO_SIDED|95.0|-0.9659|1.13|||ANCOVA|The outcome is the change of score from baseline to 12 weeks, adjusting for the baseline score.|The estimated value is the difference of score change from baseline to 12 weeks between two treatment arms (Individual-Group).|||1.13|-0.9659|0.8778
72607557|NCT02456727|144743331|SUPERIORITY||Mean Difference (Net)|0.3623|STANDARD_ERROR_OF_MEAN|0.6252||0.5626|TWO_SIDED|95.0|-0.8667|1.5912|||ANCOVA|The outcome is the change of score from baseline to 12 weeks, adjusting for the baseline score.|The estimated value is the difference of score change from baseline to 12 weeks between two treatment arms (Individual-Group).|||1.5912|-0.8667|0.5626
72607558|NCT02456727|144743332|NON_INFERIORITY|The null hypothesis is that the group treatment is inferior to the individual treatment. 10% is set as the non-inferiority margin. If the upper limit of 90% confidence interval of the estimated value does not exceed 10%, non-inferiority is demonstrated.|Risk Difference (RD)|0.0362|STANDARD_ERROR_OF_MEAN|0.0399||0.05|TWO_SIDED|95.0|-0.0419|0.1144|||Chi-squared||The estimated value is the difference of proportion of respondents (score change\>=2) at 12 weeks between two treatment arms (Individual-Group)|||0.1144|-0.0419|0.05
72607559|NCT02456727|144743333|NON_INFERIORITY|The null hypothesis is that the group treatment is inferior to the individual treatment. 10% is set as the non-inferiority margin. If the upper limit of 90% confidence interval of the estimated value does not exceed 10%, non-inferiority is demonstrated.|Risk Difference (RD)|0.0647|STANDARD_ERROR_OF_MEAN|0.0466||0.22|TWO_SIDED|95.0|-0.0266|0.156|||Chi-squared||The estimated value is the difference of proportion of respondents (score change\>=2) at 12 weeks between two treatment arms (Individual-Group)|||0.156|-0.0266|0.22
72607560|NCT02456727|144743334|NON_INFERIORITY|The null hypothesis is that the group treatment is inferior to the individual treatment. 10% is set as the non-inferiority margin. If the upper limit of 90% confidence interval of the estimated value does not exceed 10%, non-inferiority is demonstrated.|Risk Difference (RD)|0.0523|STANDARD_ERROR_OF_MEAN|0.0415||0.12|TWO_SIDED|95.0|-0.029|0.1335|||Chi-squared||The estimated value is the difference of proportion of respondents (score change\>=2) at 24 weeks between two treatment arms (Individual-Group)|||0.1335|-0.029|0.12
72607561|NCT02456727|144743335|NON_INFERIORITY|The null hypothesis is that the group treatment is inferior to the individual treatment. 10% is set as the non-inferiority margin. If the upper limit of 90% confidence interval of the estimated value does not exceed 10%, non-inferiority is demonstrated.|Risk Difference (RD)|0.0928|STANDARD_ERROR_OF_MEAN|0.0498||0.44|TWO_SIDED|95.0|-0.0047|0.1903|||Chi-squared||The estimated value is the difference of proportion of respondents (score change\>=2) at 24 weeks between two treatment arms (Individual-Group)|||0.1903|-0.0047|0.44
72325201|NCT01214837|144173593|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI around the ratio of GMCs between groups (MenACWY3 to routine vaccines) is greater than 0.5.|GMC ratio|0.85|||||TWO_SIDED|95.0|0.69|1.05|||ANOVA|||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 3 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 13 months of age for Serotype 6B.||1.05|0.69|
72325202|NCT01214837|144173593|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI around the ratio of GMCs between the groups (MenACWY4 to routine vaccines) is greater than 0.5.|GMC ratio|1.04|||||TWO_SIDED|95.0|0.83|1.3|||ANOVA|||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 4 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 13 months of age for Serotype 6B.||1.3|0.83|
72325203|NCT01214837|144173593|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI around the ratio of GMCs between groups (MenACWY3 to routine vaccines) is greater than 0.5.|GMC ratio|0.8|||||TWO_SIDED|95.0|0.67|0.95|||ANOVA|||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 3 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 13 months of age for Serotype 7F.||0.95|0.67|
72325204|NCT01214837|144173593|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI around the ratio of GMCs between the groups (MenACWY4 to routine vaccines) is greater than 0.5.|GMC ratio|1.04|||||TWO_SIDED|95.0|0.87|1.25|||ANOVA|||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 4 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 13 months of age for Serotype 7F.||1.25|0.87|
72325205|NCT01214837|144173593|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI around the ratio of GMCs between groups (MenACWY3 to routine vaccines) is greater than 0.5.|GMC ratio|0.79|||||TWO_SIDED|95.0|0.66|0.96|||ANOVA|||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 3 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 13 months of age for Serotype 9V.||0.96|0.66|
72607562|NCT02456727|144743336|SUPERIORITY||Mean Difference (Net)|0.4831|STANDARD_ERROR_OF_MEAN|0.5753||0.4014|TWO_SIDED|95.0|-0.6468|1.6129|||ANCOVA|The outcome is the change of score from baseline to 12 weeks, adjusting for the baseline score.|The estimated value is the difference of score change from baseline to 12 weeks between two treatment arms (Individual-Group).|||1.6129|-0.6468|0.4014
72607563|NCT02456727|144743337|SUPERIORITY||Mean Difference (Net)|0.6617|STANDARD_ERROR_OF_MEAN|0.647||0.307|TWO_SIDED|95.0|-0.61|1.9334|||ANCOVA|The outcome is the change of score from baseline to 12 weeks, adjusting for the baseline score.|The estimated value is the difference of score change from baseline to 12 weeks between two treatment arms (Individual-Group).|||1.9334|-0.61|0.307
72416919|NCT00518115|144344674|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.26||||0.186|TWO_SIDED|95.0|-0.64|0.12|||ANCOVA|||||0.12|-0.64|0.1860
72325206|NCT01214837|144173593|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI around the ratio of GMCs between the groups (MenACWY4 to routine vaccines) is greater than 0.5.|GMC ratio|1.07|||||TWO_SIDED|95.0|0.87|1.31|||ANOVA|||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 4 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 13 months of age for Serotype 9V.||1.31|0.87|
72416920|NCT00518115|144344674|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.62||||0.0027|TWO_SIDED|95.0|-1.03|-0.22|||ANCOVA|||||-0.22|-1.03|0.0027
72607564|NCT02456727|144743338|NON_INFERIORITY|The null hypothesis is that the group treatment is inferior to the individual treatment. 10% is set as the non-inferiority margin. If the upper limit of 90% confidence interval of the estimated value does not exceed 10%, non-inferiority is demonstrated.|Risk Difference (RD)|0.0159|STANDARD_ERROR_OF_MEAN|0.0364||0.01|TWO_SIDED|95.0|-0.0555|0.0873|||Chi-squared||The estimated value is the difference of proportion of respondents (score change\>=5) at 12 weeks between two treatment arms (Individual-Group)|||0.0873|-0.0555|0.01
72607565|NCT02456727|144743339|NON_INFERIORITY|The null hypothesis is that the group treatment is inferior to the individual treatment. 10% is set as the non-inferiority margin. If the upper limit of 90% confidence interval of the estimated value does not exceed 10%, non-inferiority is demonstrated.|Risk Difference (RD)|0.0287|STANDARD_ERROR_OF_MEAN|0.0424||0.05|TWO_SIDED|95.0|-0.0544|0.1117|||Chi-squared||The estimated value is the difference of proportion of respondents (score change\>=5) at 12 weeks between two treatment arms (Individual-Group)|||0.1117|-0.0544|0.05
72607566|NCT02456727|144743340|NON_INFERIORITY|The null hypothesis is that the group treatment is inferior to the individual treatment. 10% is set as the non-inferiority margin. If the upper limit of 90% confidence interval of the estimated value does not exceed 10%, non-inferiority is demonstrated.|Risk Difference (RD)|0.0389|STANDARD_ERROR_OF_MEAN|0.0369||0.05|TWO_SIDED|95.0|-0.0335|0.1112|||Chi-squared||The estimated value is the difference of proportion of respondents (score change\>=5) at 24 weeks between two treatment arms (Individual-Group)|||0.1112|-0.0335|0.05
72607567|NCT02456727|144743341|NON_INFERIORITY|The null hypothesis is that the group treatment is inferior to the individual treatment. 10% is set as the non-inferiority margin. If the upper limit of 90% confidence interval of the estimated value does not exceed 10%, non-inferiority is demonstrated.|Risk Difference (RD)|0.0608|STANDARD_ERROR_OF_MEAN|0.0436||0.18|TWO_SIDED|95.0|-0.0247|0.1463|||Chi-squared||The estimated value is the difference of proportion of respondents (score change\>=5) at 24 weeks between two treatment arms (Individual-Group)|||0.1463|-0.0247|0.18
72607568|NCT02456727|144743342|OTHER|The null hypothesis is that there is no change in the proportion of participants with self-reported opioid prescription comparing 12 weeks vs baseline.||||||0.1658|||||||McNemar|||Two treatment arms are combined as one group to compare the outcome of interest pre- and post-randomization.||||0.1658
72416921|NCT00518115|144344674|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.22||||0.2766|TWO_SIDED|95.0|-0.62|0.18|||ANCOVA|||||0.18|-0.62|0.2766
72416922|NCT00518115|144344674|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.55||||0.0057|TWO_SIDED|95.0|-0.94|-0.16|||ANCOVA|||||-0.16|-0.94|0.0057
72416923|NCT00518115|144344674|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.57||||0.0032|TWO_SIDED|95.0|-0.96|-0.19|||ANCOVA|||||-0.19|-0.96|0.0032
72416924|NCT00518115|144344674|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.34||||0.0786|TWO_SIDED|95.0|-0.72|0.04|||ANCOVA|||||0.04|-0.72|0.0786
72416925|NCT00518115|144344674|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6||||0.0022|TWO_SIDED|95.0|-0.99|-0.22|||ANCOVA|||||-0.22|-0.99|0.0022
72607569|NCT02456727|144743343|OTHER|The null hypothesis is that there is no change in the proportion of participants with self-reported opioid prescription comparing 12 weeks vs baseline.||||||0.1172|||||||McNemar|||Two treatment arms are combined as one group to compare the outcome of interest pre- and post-randomization.||||0.1172
72607570|NCT02456727|144743344|OTHER|The null hypothesis is that there is no change in the days of self-reported opioid medication use comparing 12 weeks vs baseline.||||||0.0326|||||||Wilcoxon signed rank test|||Two treatment arms are combined as one group to compare the outcome of interest prior- and post-randomization.||||0.0326
72607571|NCT02456727|144743345|OTHER|The null hypothesis is that there is no change in the days of self-reported opioid medication use comparing 12 weeks vs baseline.||||||0.0026|||||||Wilcoxon signed rank test|||Two treatment arms are combined as one group to compare the outcome of interest prior- and post-randomization.||||0.0026
72607572|NCT02456727|144743346|SUPERIORITY|||||||0.129||||||The change in MME was not normally distributed, thus we report median and IQR rather than mean/standard deviation. We employed Mann-Whitney to assess whether the change in MME between pre- and post-treatment periods differed across intervention arms.|Wilcoxon (Mann-Whitney)|||||||0.129
72607573|NCT02456727|144743347|SUPERIORITY|||||||0.031||||||The change in MME was not normally distributed, thus we report median and IQR rather than mean/standard deviation. We employed Mann-Whitney to assess whether the change in MME between pre- and post-treatment periods differed across intervention arms.|Wilcoxon (Mann-Whitney)|||||||0.031
72607574|NCT02456727|144743348|SUPERIORITY|Difference in change in proportion pre and post-treatment differs by treatment arm.||||||0.0059|||||||Mixed Models Analysis|||||||0.0059
72607575|NCT02456727|144743349|SUPERIORITY|||||||0.0385|||||||Mixed Models Analysis|||||||0.0385
72607576|NCT02974868|144743353|SUPERIORITY||Mean of Difference from Placebo|31.14|STANDARD_ERROR_OF_MEAN|6.25|<|0.0001|TWO_SIDED|95.0|18.78|43.5||Hochberg P-value (one-sided)|Mixed Model Repeated Measure (MMRM)|MMRM contains fixed factors of treatment, week, baseline, treatment by week and treatment by baseline interaction and a random effect for subject.||||43.50|18.78|<.0001
72607577|NCT02974868|144743353|SUPERIORITY||Mean of Difference from Placebo|49.18|STANDARD_ERROR_OF_MEAN|6.35|<|0.0001|TWO_SIDED|95.0|36.62|61.74||Hochberg P-value (one-sided)|Mixed Model Repeated Measure (MMRM)|MMRM contains fixed factors of treatment, week, baseline, treatment by week and treatment by baseline interaction and a random effect for subject.||||61.74|36.62|<.0001
72607578|NCT02974868|144743354|OTHER||Mean of Difference from Placebo|25.78|STANDARD_ERROR_OF_MEAN|10.64||0.0094|TWO_SIDED|90.0|7.98|43.58|||Mixed Model Repeated Measure (MMRM)|MMRM contains fixed factors of treatment, week, baseline, treatment by week and treatment by baseline interaction and a random effect for subject.||||43.58|7.98|0.0094
72607579|NCT02974868|144743354|OTHER||Mean of Difference from Placebo|46.61|STANDARD_ERROR_OF_MEAN|10.51|<|0.0001|TWO_SIDED|90.0|29.02|64.2|||Mixed Model Repeated Measure|MMRM contains fixed factors of treatment, week, baseline, treatment by week and treatment by baseline interaction and a random effect for subject.||||64.20|29.02|<.0001
72607580|NCT02974868|144743359|OTHER||Difference in Percentage from Placebo|47.9|||<|0.0001|TWO_SIDED|90.0|34.2|60.7|||Chan and Zhang method|||||60.7|34.2|<.0001
72607581|NCT02974868|144743359|OTHER||Difference in Percentage from Placebo|61.7|||<|0.0001|TWO_SIDED|90.0|48.2|73.6|||Chan and Zhang method|||||73.6|48.2|<.0001
72607582|NCT03575702|144743385|NON_INFERIORITY|The non-inferiority margin is considered as change in mean daily urination episodes of 0,8 episodes per day|Mean Difference (Final Values)|0.17|STANDARD_ERROR_OF_MEAN|0.34|=|0.5595|ONE_SIDED|95.0||0.38|||ANCOVA|The number of urination episodes at the initiation of therapy is used as covariate, and the therapy group is used as a factor.||"The null hypothesis is that effect of Urotol according to the assessment of mean daily urination episodes exceeds effect of Uritos.~A sample containing of 222 patients (111 per study group) is considered sufficient to prove the alternative hypothesis at the significance level 0.025% and study power 80%. Given the expected drop out rate during the treatment period, the total number of patients to be randomized is 300 (150 in each group)."||0.38||=0.5595
72607583|NCT03575702|144743386|OTHER||||||=|0.0008|||||||ANCOVA|||||||=0.0008
72607584|NCT03575702|144743387|OTHER||||||=|0.0099|||||||ANCOVA|||||||=0.0099
72607585|NCT03575702|144743388|OTHER||||||<|0.0001|||||||ANCOVA|||||||<0.0001
72607586|NCT03575702|144743389|OTHER||||||<|0.0001|||||||ANCOVA|Changes in number of daily incontinence episodes - week 2||||||<0.0001
72607587|NCT03575702|144743389|OTHER||||||=|0.0236|||||||ANCOVA|Changes in number of daily incontinence episodes - week 4||||||=0.0236
72607588|NCT03575702|144743389|OTHER||||||<|0.0001|||||||ANCOVA|Changes in number of daily incontinence episodes - week 8||||||<0.0001
72607589|NCT03575702|144743389|OTHER||||||=|0.0018|||||||ANCOVA|Changes in daytime number of daily incontinence episodes - week 2||||||=0.0018
72607590|NCT03575702|144743389|OTHER||||||=|0.3835|||||||ANCOVA|Changes in daytime number of daily incontinence episodes - week 4||||||=0.3835
72607591|NCT03575702|144743389|OTHER||||||=|0.0088|||||||ANCOVA|Changes in daytime number of daily incontinence episodes - week 8||||||=0.0088
72607592|NCT03575702|144743389|OTHER||||||=|0.0004|||||||ANCOVA|Changes in nighttime number of daily incontinence episodes - week 2||||||=0.0004
72607593|NCT03575702|144743389|OTHER||||||<|0.0001|||||||ANCOVA|Changes in nighttime number of daily incontinence episodes - week 4||||||<0.0001
72607594|NCT03575702|144743389|OTHER||||||<|0.0001|||||||ANCOVA|Changes in nighttime number of daily incontinence episodes - week 8||||||<0.0001
72607595|NCT03575702|144743390|OTHER|||||||0.0008|||||||ANCOVA|||||||0.0008
72607596|NCT03575702|144743391|OTHER||||||=|0.1348|||||||ANCOVA|Week 2 changes||||||=0.1348
72607597|NCT03575702|144743391|OTHER||||||=|0.3199|||||||ANCOVA|Week 4 changes||||||=0.3199
72607598|NCT03575702|144743391|OTHER||||||=|0.9537|||||||ANCOVA|Week 8 changes||||||=0.9537
72607599|NCT03575702|144743392|OTHER||||||=|0.5321|||||||t-test, 1 sided|Change week 12||||||=0.5321
72607600|NCT03575702|144743393|OTHER||||||=|0.4839|||||||t-test, 1 sided|Change week 12||||||=0.4839
72607601|NCT03575702|144743394|OTHER||||||=|0.86|||||||Chi-squared|||||||=0.86
72607602|NCT03903172|144743400|SUPERIORITY||||||=|0.25|||||||t-test, 2 sided|||Day 0||||=0.25
72607603|NCT03903172|144743400|SUPERIORITY||||||=|0.93|||||||t-test, 2 sided|||Day 1||||=.93
72607604|NCT03903172|144743401|SUPERIORITY||||||=|1|||||||Fisher Exact|||Used acetominophen||||=1.0
72607605|NCT03903172|144743401|SUPERIORITY||||||=|1|||||||Fisher Exact|||Used ibuprofen||||=1.0
72607606|NCT03903172|144743401|SUPERIORITY||||||=|1|||||||Fisher Exact|||Used Cyclobenzaprine||||=1.0
72607607|NCT03903172|144743401|SUPERIORITY||||||=|0.11|||||||Fisher Exact|||Used Methocarbamol||||=.11
72416926|NCT04891419|144344693|SUPERIORITY||Rate Difference|91.1|||<|0.0001|TWO_SIDED|95.0|83.7|95.9||P-value is based on the Fisher's Exact Test.|Fisher Exact||95% exact unconditional confidence interval for between-group difference in responder rate.|||95.9|83.7|<.0001
72607608|NCT03903172|144743401|SUPERIORITY||||||=|0.49|||||||Fisher Exact|||Used Hydroxyzine||||=.49
72607609|NCT03903172|144743401|SUPERIORITY||||||=|1|||||||Fisher Exact|||Used an 'Other' non-pharmacologic medication||||=1.0
72607610|NCT03903172|144743402|SUPERIORITY||||||=|1|||||||Fisher Exact|||Any narcotic medication used||||=1.0
72607611|NCT01545388|144743403|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.678|||<|0.001|TWO_SIDED|95.0|-0.868|-0.489|||cLDA|Based on a cLDA model with the terms listed above and a constraint that the mean baseline is the same for all treatment groups.||||-0.489|-0.868|<0.001
72607612|NCT01545388|144743403|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.525|||<|0.001|TWO_SIDED|95.0|-0.713|-0.337|||cLDA|Based on a cLDA model with the terms listed above and a constraint that the mean baseline is the same for all treatment groups.||||-0.337|-0.713|<0.001
72607613|NCT01545388|144743403|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin (Δ) is set as 0.3% to show the non-inferiority of metformin 500 mg q.d. to metformin 250 mg b.i.d.|Difference in least squares means|0.153|||||TWO_SIDED|95.0|0.0|0.306||||||||0.306|0.000|
72607614|NCT01545388|144743404|SUPERIORITY_OR_OTHER||Difference in least squares means|-18.59|||<|0.001|TWO_SIDED|95.0|-25.94|-11.24|||cLDA|Based on a cLDA model with the terms listed above and a constraint that the mean baseline is the same for all treatment groups.||||-11.24|-25.94|<0.001
72607615|NCT01545388|144743404|SUPERIORITY_OR_OTHER||Difference in least squares means|-16.34|||<|0.001|TWO_SIDED|95.0|-23.62|-9.06|||cLDA|Based on a cLDA model with the terms listed above and a constraint that the mean baseline is the same for all treatment groups.||||-9.06|-23.62|<0.001
72607616|NCT01545388|144743404|SUPERIORITY_OR_OTHER||Difference in least squares mean|2.25|||||TWO_SIDED|95.0|-3.63|8.14||||||||8.14|-3.63|
72607617|NCT01255163|144743407|OTHER|||||||0.016||||||threshold for significance (p \< 0.05)|Fisher Exact|||||||0.016
72416927|NCT04891419|144344694|SUPERIORITY||Control Difference|54.5|STANDARD_ERROR_OF_MEAN|2.69|<|0.0001|TWO_SIDED|95.0|49.2|59.9||P-value estimated using mixed effects model.|Mixed Models Analysis||95% CI estimated using mixed effects model.|||59.9|49.2|<.0001
72416928|NCT04891419|144344695|SUPERIORITY||Control Difference|42.8|STANDARD_ERROR_OF_MEAN|2.63|<|0.0001|TWO_SIDED|95.0|37.6|48.0||95% CI and p-value estimated using mixed effects model.|Mixed Models Analysis|||||48.0|37.6|<.0001
72607618|NCT01255163|144743408|OTHER|||||||0.098||||||"Threshold for statistical significance p \< 0.05.~Type III Tests of Fixed Effects Group \* VisitLong F (6, 52.008) = 1.902, p = 0.098"|Mixed Models Analysis|Repeated measures mixed model with Repeated Factor (Visit Long: baseline, 6, 12, 18 months), Fixed Factors (Group,VisitLong, Sex) and Covariate (Age)|||"MIXED MMSE.tot BY Group Sex VisitLong WITH Age~* CRITERIA=CIN(95) MXITER(100) MXSTEP(10) SCORING(1) SINGULAR(0.000000000001) HCONVERGE(0, ABSOLUTE) LCONVERGE(0, ABSOLUTE) PCONVERGE(0.000001, ABSOLUTE)~* FIXED=Group Sex Age Group\*VisitLong \| SSTYPE(3)~* METHOD=REML~* PRINT=SOLUTION~* REPEATED=VisitLong \| SUBJECT(SubjectID) COVTYPE(AR1)~* EMMEANS=TABLES(Group) COMPARE ADJ(BONFERRONI)~* EMMEANS=TABLES(Sex) COMPARE ADJ(BONFERRONI)~* EMMEANS=TABLES(Group\*VisitLong) COMPARE(Group) ADJ(BONFERRONI)~* EMMEANS=TABLES(Group\*VisitLong) COMPARE(VisitLong) ADJ(BONFERRONI) ."|||0.098
72607619|NCT01255163|144743409|OTHER|||||||0.295||||||"Threshold for statistical significance p \< 0.05.~Type III Tests of Fixed Effects for Group\*VisitLong F (6, 52.281) = 1.254, p = 0.295"|Mixed Models Analysis|Repeated measures mixed model with Repeated Factor (Visit Long: baseline, 6, 12, 18 months), Fixed Factors (Group,VisitLong, Sex) and Covariate (Age)|||"MIXED ADAS70 BY Group Sex VisitLong WITH Age~* CRITERIA=CIN(95) MXITER(100) MXSTEP(10) SCORING(1) SINGULAR(0.000000000001) HCONVERGE(0, ABSOLUTE) LCONVERGE(0, ABSOLUTE) PCONVERGE(0.000001, ABSOLUTE)~* FIXED=Group Sex Age Group\*VisitLong \| SSTYPE(3)~* METHOD=REML~* PRINT=SOLUTION~* REPEATED=VisitLong \| SUBJECT(SubjectID) COVTYPE(AR1)~* EMMEANS=TABLES(Group) COMPARE ADJ(BONFERRONI)~* EMMEANS=TABLES(Sex) COMPARE ADJ(BONFERRONI)~* EMMEANS=TABLES(Group\*VisitLong) COMPARE(Group) ADJ(BONFERRONI)~* EMMEANS=TABLES(Group\*VisitLong) COMPARE(VisitLong) ADJ(BONFERRONI) ."|||0.295
72607620|NCT01255163|144743410|OTHER|||||||0.141||||||Threshold for statistical significance p \< 0.05. Type III Tests of Fixed Effects Group \* VisitLong F (6, 47.485) = 1.704, p = 0.141|Mixed Models Analysis|Repeated measures mixed model with Repeated Factor (Visit Long: baseline, 6, 12, 18 months), Fixed Factors (Group,VisitLong, Sex) and Covariate (Age)|||"MIXED CDR BY Group Sex VisitLong WITH Age~CRITERIA=CIN(95) MXITER(100) MXSTEP(10) SCORING(1) SINGULAR(0.000000000001) HCONVERGE(0, ABSOLUTE) LCONVERGE(0, ABSOLUTE) PCONVERGE(0.000001, ABSOLUTE) FIXED=Group Sex Age Group\*VisitLong \| SSTYPE(3) METHOD=REML PRINT=SOLUTION REPEATED=VisitLong \| SUBJECT(SubjectID) COVTYPE(AR1) EMMEANS=TABLES(Group) COMPARE ADJ(BONFERRONI) EMMEANS=TABLES(Sex) COMPARE ADJ(BONFERRONI) EMMEANS=TABLES(Group\*VisitLong) COMPARE(Group) ADJ(BONFERRONI) EMMEANS=TABLES(Group\*VisitLong) COMPARE(VisitLong) ADJ(BONFERRONI) ."|||0.141
72607621|NCT01255163|144743411|OTHER|||||||0.031||||||Threshold for statistical significance p \< 0.05. Type III Tests of Fixed Effects: Group \* VisitLong F (6, 51.955) = 2.553, p = 0.031. Univarate Exendin-4 F(3, 51.386) = 2.734, p = 0.053. Pairwise for Exendin-4, baseline vs. 18 months (p = 0.035).|Mixed Models Analysis|Repeated measures mixed model with Repeated Factor (Visit Long: baseline, 6, 12, 18 months), Fixed Factors (Group,VisitLong, Sex) and Covariate (Age)|||"MIXED CDR.sob BY Group Sex VisitLong WITH Age CRITERIA=CIN(95) MXITER(100) MXSTEP(10) SCORING(1) SINGULAR(0.000000000001) HCONVERGE(0, ABSOLUTE) LCONVERGE(0, ABSOLUTE) PCONVERGE(0.000001, ABSOLUTE) FIXED=Group Sex Age Group\*VisitLong \| SSTYPE(3) METHOD=REML PRINT=SOLUTION REPEATED=VisitLong \| SUBJECT(SubjectID) COVTYPE(AR1) EMMEANS=TABLES(Group) COMPARE ADJ(BONFERRONI) EMMEANS=TABLES(Sex) COMPARE ADJ(BONFERRONI) EMMEANS=TABLES(Group\*VisitLong) COMPARE(Group) ADJ(BONFERRONI) EMMEANS=TABLES(Group\*VisitLong) COMPARE(VisitLong) ADJ(BONFERRONI) ."|||0.031
72607622|NCT01255163|144743412|OTHER|||||||0.703||||||Threshold for statistical significance p \< 0.05. Type III Tests of Fixed Effects Group \* VisitLong F (2, 15.251) = 0.360, p = 0.703.|Mixed Models Analysis|Repeated measures mixed model with Repeated Factor (Visit Long: baseline,18 months), Fixed Factors (Group,VisitLong, Sex) and Covariate (Age)|||"MIXED TAU BY Group Sex VisitLong WITH Age CRITERIA=CIN(95) MXITER(100) MXSTEP(10) SCORING(1) SINGULAR(0.000000000001) HCONVERGE(0, ABSOLUTE) LCONVERGE(0, ABSOLUTE) PCONVERGE(0.000001, ABSOLUTE) FIXED=Group Sex Age Group\*VisitLong \| SSTYPE(3) METHOD=REML PRINT=SOLUTION REPEATED=VisitLong \| SUBJECT(SubjectID) COVTYPE(AR1) EMMEANS=TABLES(Group) COMPARE ADJ(BONFERRONI) EMMEANS=TABLES(Sex) COMPARE ADJ(BONFERRONI) EMMEANS=TABLES(Group\*VisitLong) COMPARE(Group) ADJ(BONFERRONI) EMMEANS=TABLES(Group\*VisitLong) COMPARE(VisitLong) ADJ(BONFERRONI) ."|||0.703
72416929|NCT04891419|144344696|SUPERIORITY||Rate Difference|93.1|||<|0.0001|TWO_SIDED|95.0|86.1|97.2||P-value is based on Fisher's Exact Test.|Fisher Exact||95% exact unconditional confidence interval for between-group difference in responder rate.|||97.2|86.1|<.0001
72416930|NCT04891419|144344697|SUPERIORITY||Rate Difference|92.1|||<|0.0001|TWO_SIDED|95.0|84.9|96.5||P-value is based on Fisher's Exact Test.|Fisher Exact||95% exact unconditional confidence interval for between-group difference in responder rate.|||96.5|84.9|<.0001
72416931|NCT00827918|144344698|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6||||0.859|TWO_SIDED|95.0|-7.0|5.8|||Difference in the Least Squares Mean|||||5.8|-7.0|0.8590
72416932|NCT00827918|144344698|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.3||||0.2534|TWO_SIDED|95.0|-11.7|3.1|||Difference in the Least Squares Mean|||||3.1|-11.7|0.2534
72416933|NCT00827918|144344701|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.28||||0.4976|TWO_SIDED|95.0|0.62|2.64|||Generalized linear mixed analysis model|||||2.64|0.62|0.4976
72607623|NCT01255163|144743413|OTHER|||||||0.845||||||Threshold for statistical significance p \< 0.05. Type III Tests of Fixed Effects Group \* VisitLong F (2, 15.828) = 0.170, p = 0.845.|Mixed Models Analysis|Repeated measures mixed model with Repeated Factor (Visit Long: baseline,18 months), Fixed Factors (Group,VisitLong, Sex) and Covariate (Age)|||"MIXED pTAU BY Group Sex VisitLong WITH Age CRITERIA=CIN(95) MXITER(100) MXSTEP(10) SCORING(1) SINGULAR(0.000000000001) HCONVERGE(0, ABSOLUTE) LCONVERGE(0, ABSOLUTE) PCONVERGE(0.000001, ABSOLUTE) FIXED=Group Sex Age Group\*VisitLong \| SSTYPE(3) METHOD=REML PRINT=SOLUTION REPEATED=VisitLong \| SUBJECT(SubjectID) COVTYPE(AR1) EMMEANS=TABLES(Group) COMPARE ADJ(BONFERRONI) EMMEANS=TABLES(Sex) COMPARE ADJ(BONFERRONI) EMMEANS=TABLES(Group\*VisitLong) COMPARE(Group) ADJ(BONFERRONI) EMMEANS=TABLES(Group\*VisitLong) COMPARE(VisitLong) ADJ(BONFERRONI) ."|||0.845
72325207|NCT01214837|144173593|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI around the ratio of GMCs between groups (MenACWY3 to routine vaccines) is greater than 0.5.|GMC ratio|1.03|||||TWO_SIDED|95.0|0.84|1.27|||ANOVA|||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 3 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 13 months of age for Serotype 14.||1.27|0.84|
72607624|NCT01255163|144743414|OTHER|||||||0.018||||||Type III Tests of Fixed Effects: Group \* VisitLong F (2, 16.614) = 5.142, p = 0.018. Univariate tests: Placebo F(1, 16.595) = 4.138, p = 0.058; Exendin-4 F(1, 16.595) = 6.262, p = 0.022. Pairwise for Exendin-4, baseline vs. 18 months (p = 0.022).|Mixed Models Analysis|Repeated measures mixed model with Repeated Factor (Visit Long: baseline,18 months), Fixed Factors (Group,VisitLong, Sex) and Covariate (Age)|||"MIXED Ab42 BY Group Sex VisitLong WITH Age CRITERIA=CIN(95) MXITER(100) MXSTEP(10) SCORING(1) SINGULAR(0.000000000001) HCONVERGE(0, ABSOLUTE) LCONVERGE(0, ABSOLUTE) PCONVERGE(0.000001, ABSOLUTE) FIXED=Group Sex Age Group\*VisitLong \| SSTYPE(3) METHOD=REML PRINT=SOLUTION REPEATED=VisitLong \| SUBJECT(SubjectID) COVTYPE(AR1) EMMEANS=TABLES(Group) COMPARE ADJ(BONFERRONI) EMMEANS=TABLES(Sex) COMPARE ADJ(BONFERRONI) EMMEANS=TABLES(Group\*VisitLong) COMPARE(Group) ADJ(BONFERRONI) EMMEANS=TABLES(Group\*VisitLong) COMPARE(VisitLong) ADJ(BONFERRONI) ."|||0.018
72607625|NCT01255163|144743415|OTHER|||||||0.009||||||Type III Tests of Fixed Effects: Group \* VisitLong F (8, 72.603) = 2.816, p = 0.009. Univarate Exendin-4 F(4, 72.944) = 4.834, p = 0.002. Pairwise comparisons for Exendin-4 showed a decrease in BMI baseline vs. 6 months (p = 0.029).|Mixed Models Analysis|Repeated measures mixed model with Repeated Factor (Visit Long: baseline, 6, 12, 18 months), Fixed Factors (Group,VisitLong, Sex) and Covariate (Age)|||"MIXED BMI BY Group Sex VisitLong WITH Age CRITERIA=CIN(95) MXITER(100) MXSTEP(10) SCORING(1) SINGULAR(0.000000000001) HCONVERGE(0, ABSOLUTE) LCONVERGE(0, ABSOLUTE) PCONVERGE(0.000001, ABSOLUTE) FIXED=Group Sex Age Group\*VisitLong \| SSTYPE(3) METHOD=REML PRINT=SOLUTION REPEATED=VisitLong \| SUBJECT(SubjectID) COVTYPE(AR1) EMMEANS=TABLES(Group) COMPARE ADJ(BONFERRONI) EMMEANS=TABLES(Sex) COMPARE ADJ(BONFERRONI) EMMEANS=TABLES(Group\*VisitLong) COMPARE(Group) ADJ(BONFERRONI) EMMEANS=TABLES(Group\*VisitLong) COMPARE(VisitLong) ADJ(BONFERRONI) ."|||0.009
72607626|NCT02495389|144743417|SUPERIORITY||Mean Difference (Final Values)|23.96|STANDARD_ERROR_OF_MEAN|2.7741|<|0.0001|TWO_SIDED|95.0|18.35|29.57|||t-test, 2 sided|A two-sided paired t-test was used for this analysis.||The null hypothesis is that there is no change in patients' baseline Overactive Bladder Questionnaire (OAB-q) Health Related Quality of Life (HRQL) score after 12 weeks of therapy.||29.57|18.35|<.0001
72607627|NCT02495389|144743418|SUPERIORITY||Mean Difference (Final Values)|-51.62|STANDARD_ERROR_OF_MEAN|6.1584|<|0.0001|TWO_SIDED|95.0|-64.04|-39.2|||t-test, 2 sided|A two-sided paired t-test was used for this analysis.||The null hypothesis is that there is no change in patients' baseline Urinary Distress Inventory score after 12 weeks of therapy.||-39.20|-64.04|<.0001
72607628|NCT02495389|144743419|SUPERIORITY||Mean Difference (Final Values)|-29.3|STANDARD_ERROR_OF_MEAN|5.4701|<|0.0001|TWO_SIDED|95.0|-40.33|-18.27|||t-test, 2 sided|A two-sided paired t-test was used for this analysis.||The null hypothesis is that there is no change in patients' baseline Pelvic Organ Prolapse Distress Inventory score after 12 weeks of therapy.||-18.27|-40.33|<.0001
72607629|NCT02495389|144743420|SUPERIORITY||Mean Difference (Final Values)|-32.0|STANDARD_ERROR_OF_MEAN|6.1226|<|0.0001|TWO_SIDED|95.0|-44.35|-19.65|||t-test, 2 sided|A two-sided paired t-test was used for this analysis.||The null hypothesis is that there is no change in patients' baseline Colo-Rectal-Anal Distress Inventory score after 12 weeks of therapy.||-19.65|-44.35|<.0001
72607630|NCT05559905|144743443|SUPERIORITY||Difference in Least Squares Mean|-0.29||||0.578|TWO_SIDED|90.0|-1.16|0.58|||ANOVA|||Per protocol, only Panel A (prophylaxis) and Panel C (placebo) were included in the model. The mean PVL in each group and the differences in mean PVL between MK-4482 and placebo and the corresponding 2- sided 95% CI were computed based on the linear model.||0.58|-1.16|0.578
72607631|NCT05559905|144743444|SUPERIORITY||Difference in Least Squares Mean|-2.69||||0.201|TWO_SIDED|90.0|-6.17|-0.79|||ANOVA|||Per protocol, only Panel B (treatment) and Panel C (placebo) were included in the model. For both panels, only the participants with RSV infection were included in the analysis. The mean VL-AUC in each group and the differences in mean VL-AUC between MK-4482 and placebo and the corresponding 2-sided 95% CI were computed based on the linear model.||-0.79|-6.17|0.201
72607632|NCT05559905|144743450|SUPERIORITY||Difference in Least Squares Mean|-0.62||||0.736|TWO_SIDED|90.0|-3.65|2.42|||ANOVA|||Per protocol, only Panel A (prophylaxis) and Panel C (placebo) were included in the model. The mean VL-AUC in each group and the differences in mean VL-AUC between MK-4482 and placebo and the corresponding 2-sided 95% CI were computed based on the linear model.||2.42|-3.65|0.736
72607633|NCT05559905|144743451|SUPERIORITY||Difference in Least Squares Mean|-1.93||||0.646|TWO_SIDED|90.0|-8.88|5.02|||ANOVA|||Per protocol, only Panel A (prophylaxis) and Panel C (placebo) were included in the model. The mean VL-AUC in each group and the differences in mean VL-AUC between MK-4482 and placebo and the corresponding 2-sided 95% CI were computed based on the linear model.||5.02|-8.88|0.646
72607634|NCT05559905|144743452|SUPERIORITY||Difference in Least Squares Mean|-0.14||||0.849|TWO_SIDED|90.0|-1.31|1.04|||ANOVA|||Per protocol, only Panel A (prophylaxis) and Panel C (placebo) were included in the model. The mean PVL in each group and the differences in mean PVL between MK-4482 and placebo and the corresponding 2- sided 95% CI were computed based on the linear model.||1.04|-1.31|0.849
72416934|NCT00827918|144344701|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.2||||0.0653|TWO_SIDED|95.0|0.95|5.09|||Generalized linear mixed analysis model|||||5.09|0.95|0.0653
72325208|NCT01214837|144173593|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI around the ratio of GMCs between the groups (MenACWY4 to routine vaccines) is greater than 0.5.|GMC ratio|1.04|||||TWO_SIDED|95.0|0.83|1.3|||ANOVA|||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 4 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 13 months of age for Serotype 14.||1.3|0.83|
72325209|NCT01214837|144173593|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI around the ratio of GMCs between groups (MenACWY3 to routine vaccines) is greater than 0.5.|GMC ratio|0.72|||||TWO_SIDED|95.0|0.59|0.87|||ANOVA|||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 3 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 13 months of age for Serotype 18C.||0.87|0.59|
72325210|NCT01214837|144173593|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI around the ratio of GMCs between the groups (MenACWY4 to routine vaccines) is greater than 0.5.|GMC ratio|1.1|||||TWO_SIDED|95.0|0.89|1.36|||ANOVA|||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 4 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 13 months of age for Serotype 18C.||1.36|0.89|
72325211|NCT01214837|144173593|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI around the ratio of GMCs between groups (MenACWY3 to routine vaccines) is greater than 0.5.|GMC ratio|1.02|||||TWO_SIDED|95.0|0.83|1.27|||ANOVA|||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 3 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 13 months of age for Serotype 19A.||1.27|0.83|
72325212|NCT01214837|144173593|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI around the ratio of GMCs between the groups (MenACWY4 to routine vaccines) is greater than 0.5.|GMC ratio|0.97|||||TWO_SIDED|95.0|0.77|1.21|||ANOVA|||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 4 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 13 months of age for Serotype 19A.||1.21|0.77|
72416935|NCT00827918|144344702|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.8199|TWO_SIDED|95.0|-0.4|0.3|||Constrained longitudinal data analysis|||||0.3|-0.4|0.8199
72607635|NCT05559905|144743453|SUPERIORITY||Difference in Least Squares Mean|-2.09||||0.371|TWO_SIDED|90.0|-5.97|1.78|||ANOVA|||Per protocol, only Panel A (prophylaxis) and Panel C (placebo) were included in the model. The TSS-AUC in each group and the differences in mean TSS-AUC between MK-4482 and placebo and the corresponding 2- sided 95% CI were computed based on the linear model.||1.78|-5.97|0.371
72325213|NCT01214837|144173593|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI around the ratio of GMCs between groups (MenACWY3 to routine vaccines) is greater than 0.5.|GMC ratio|1.0|||||TWO_SIDED|95.0|0.82|1.22|||ANOVA|||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 3 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 13 months of age for Serotype 19F.||1.22|0.82|
72607636|NCT05559905|144743454|SUPERIORITY||Difference in Least Squares Mean|-1.82||||0.36|TWO_SIDED|90.0|-5.11|1.47|||ANOVA|||Per protocol, only Panel A (prophylaxis) and Panel C (placebo) were included in the model. The TSS-AUC-CFB in each group and the differences in mean TSS-AUC-CFB between MK-4482 and placebo and the corresponding 2- sided 95% CI were computed based on the linear model.||1.47|-5.11|0.360
72325214|NCT01214837|144173593|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI around the ratio of GMCs between the groups (MenACWY4 to routine vaccines) is greater than 0.5.|GMC ratio|1.07|||||TWO_SIDED|95.0|0.86|1.32|||ANOVA|||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 4 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 13 months of age for Serotype 19F.||1.32|0.86|
72416936|NCT00827918|144344702|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.9486|TWO_SIDED|95.0|-0.4|0.4|||Constrained longitudinal data analysis|||||0.4|-0.4|0.9486
72607637|NCT05559905|144743455|SUPERIORITY||Difference in Least Squares Mean|-0.46||||0.459|TWO_SIDED|90.0|-1.5|0.57|||ANOVA|||Per protocol, only Panel A (prophylaxis) and Panel C (placebo) were included in the model. The mean peak TSS in each group and the differences in mean peak TSS between MK-4482 and placebo and the corresponding 2- sided 95% CI was computed based on the linear model.||0.57|-1.50|0.459
72325215|NCT01214837|144173593|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI around the ratio of GMCs between groups (MenACWY3 to routine vaccines) is greater than 0.5.|GMC ratio|0.77|||||TWO_SIDED|95.0|0.62|0.97|||ANOVA|||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 3 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 13 months of age for Serotype 23F.||0.97|0.62|
72325216|NCT01214837|144173593|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI around the ratio of GMCs between the groups (MenACWY4 to routine vaccines) is greater than 0.5.|GMC ratio|0.89|||||TWO_SIDED|95.0|0.7|1.13|||ANOVA|||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 4 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 13 months of age for Serotype 23F.||1.13|0.7|
72325217|NCT03257358|144173614|OTHER|Estimation|least squares mean|-413.4|STANDARD_ERROR_OF_MEAN|4.7|||TWO_SIDED|95.0|-422.7||||ANCOVA|||||-404.|-422.7|
72325218|NCT03257358|144173614|OTHER|Estimation|least squares mean|-0.2|STANDARD_ERROR_OF_MEAN|1.91|||TWO_SIDED|95.0|-3.9|3.6|||ANCOVA|||||3.6|-3.9|
72325219|NCT03257358|144173615|OTHER|Estimation|least squares mean|-368.7|STANDARD_ERROR_OF_MEAN|7.08|||TWO_SIDED|95.0|-382.8|354.7|||ANCOVA|||||354.7|-382.8|
72325220|NCT03257358|144173615|OTHER|Estimation|least squares mean|-0.1|STANDARD_ERROR_OF_MEAN|3.54|||TWO_SIDED|95.0|-7.1|6.9|||ANCOVA|||||6.9|-7.1|
72416937|NCT00827918|144344703|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.9937|TWO_SIDED|95.0|-2.0|2.0|||Constrained longitudinal data analysis|||||2.0|-2.0|0.9937
72416938|NCT00827918|144344703|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.3||||0.2406|TWO_SIDED|95.0|-3.6|0.9|||Constrained longitudinal data analysis|||||0.9|-3.6|0.2406
72325221|NCT03257358|144173616|OTHER|Estimation|least squares mean|-52.1|STANDARD_ERROR_OF_MEAN|2.58|||TWO_SIDED|95.0|-57.2|-46.9|||ANCOVA|||||-46.9|-57.2|
72325222|NCT03257358|144173616|OTHER|Estimation|least squares mean|-3.1|STANDARD_ERROR_OF_MEAN|2.27|||TWO_SIDED|95.0|-7.6|1.4|||ANCOVA|||||1.4|-7.6|
72325223|NCT03257358|144173617|OTHER|Estimation|least squares mean|-43.6|STANDARD_ERROR_OF_MEAN|1.67|||TWO_SIDED|95.0|-46.9|-40.3|||ANCOVA|||||-40.3|-46.9|
72325224|NCT03257358|144173617|OTHER|Estimation|least squares mean|-0.7|STANDARD_ERROR_OF_MEAN|1.18|||TWO_SIDED|95.0|-3.0|1.7|||ANCOVA|||||1.7|-3.0|
72325225|NCT03257358|144173618|OTHER|Estimation|least squares mean|-36.3|STANDARD_ERROR_OF_MEAN|0.48|||TWO_SIDED|95.0|-37.2|-35.3|||ANCOVA|||||-35.3|-37.2|
72325226|NCT03257358|144173618|OTHER|Estimation|least squares mean|0.4|STANDARD_ERROR_OF_MEAN|0.42|||TWO_SIDED|95.0|-0.4|1.2|||ANCOVA|||||1.2|-0.4|
72325227|NCT03257358|144173619|OTHER|Estimation|least squares mean|-53.2|STANDARD_ERROR_OF_MEAN|0.97|||TWO_SIDED|95.0|-55.1|-51.3|||ANCOVA|||||-51.3|-55.1|
72325228|NCT03257358|144173619|OTHER|Estimation|least squares mean|0.4|STANDARD_ERROR_OF_MEAN|0.51|||TWO_SIDED|95.0|-0.7|1.4|||ANCOVA|||||1.4|-0.7|
72325229|NCT03257358|144173620|OTHER|Estimation|least squares mean|-140.4|STANDARD_ERROR_OF_MEAN|2.71|||TWO_SIDED|95.0|-145.8|-135.0|||ANCOVA|||||-135.0|-145.8|
72607638|NCT05559905|144743457|SUPERIORITY||Difference in Percent (%)|3.42|||||TWO_SIDED|95.0|-18.28|24.5||||||||24.50|-18.28|
72325230|NCT03257358|144173620|OTHER|Estimation|least squares mean|0.7|STANDARD_ERROR_OF_MEAN|1.3|||TWO_SIDED|95.0|-1.9|3.3|||ANCOVA|||||3.3|-1.9|
72325231|NCT03257358|144173621|OTHER|Estimation|least squares mean|-85.2|STANDARD_ERROR_OF_MEAN|1.92|||TWO_SIDED|95.0|-89.0|-81.4|||ANCOVA|||||-81.4|-89.0|
72325232|NCT03257358|144173621|OTHER|Estimation|least squares mean|0.2|STANDARD_ERROR_OF_MEAN|1.06|||TWO_SIDED|95.0|-2.3|1.9|||ANCOVA|||||1.9|-2.3|
72325233|NCT03257358|144173622|OTHER|Estimation|least squares mean|-27.9|STANDARD_ERROR_OF_MEAN|11.65|||TWO_SIDED|95.0|-51.1|-4.8|||ANCOVA|||||-4.8|-51.1|
72325234|NCT03257358|144173622|OTHER|Estimation|least squares mean|-9.4|STANDARD_ERROR_OF_MEAN|3.47|||TWO_SIDED|95.0|-16.3|-2.6|||ANCOVA|||||-2.6|-16.3|
72325235|NCT03257358|144173623|OTHER|Estimation|least squares mean|-181.2|STANDARD_ERROR_OF_MEAN|1.07|||TWO_SIDED|95.0|-183.3|-179.0|||ANCOVA|||||-179.0|-183.3|
72325236|NCT03257358|144173623|OTHER|Estimation|least squares mean|-0.8|STANDARD_ERROR_OF_MEAN|1.66|||TWO_SIDED|95.0|-4.1|2.5|||ANCOVA|||||2.5|-4.1|
72325237|NCT03257358|144173624|OTHER|Estimation|least squares mean|-55.2|STANDARD_ERROR_OF_MEAN|0.66|||TWO_SIDED|95.0|-56.5|-53.9|||ANCOVA|||||-53.9|-56.5|
72416939|NCT00827918|144344704|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4||||0.5953|TWO_SIDED|95.0|-2.0|1.2|||Constrained longitudinal data analysis|||||1.2|-2.0|0.5953
72607639|NCT05559905|144743458|SUPERIORITY||Difference in Percent (%)|2.89|||||TWO_SIDED|95.0|-19.37|25.69||||||||25.69|-19.37|
72325238|NCT03257358|144173624|OTHER|Estimation|least squares mean|0.3|STANDARD_ERROR_OF_MEAN|0.42|||TWO_SIDED|95.0|-0.5|1.1|||ANCOVA|||||1.1|-0.5|
72325239|NCT03257358|144173625|OTHER|Estimation|least squares mean|-7.2|STANDARD_ERROR_OF_MEAN|0.4|||TWO_SIDED|95.0|-8.0|-6.4|||ANCOVA|||||-6.4|-8.0|
72325240|NCT03257358|144173625|OTHER|Estimation|least squares mean|1.1|STANDARD_ERROR_OF_MEAN|0.43|||TWO_SIDED|95.0|0.3|2.0|||ANCOVA|||||2.0|0.3|
72325241|NCT03257358|144173626|OTHER|Estimation|least squares mean|69.4|STANDARD_ERROR_OF_MEAN|13.78|||TWO_SIDED|95.0|42.1|96.7|||ANCOVA|||||96.7|42.1|
72325242|NCT03257358|144173626|OTHER|Estimation|least squares mean|117.0|STANDARD_ERROR_OF_MEAN|10.07|||TWO_SIDED|95.0|97.1|136.9|||ANCOVA|||||136.9|97.1|
72325243|NCT03257358|144173627|OTHER|Estimation|least squares mean|-782.6|STANDARD_ERROR_OF_MEAN|138.9|||TWO_SIDED|95.0|-1058.2|-507.1|||ANCOVA|||||-507.1|-1058.2|
72325244|NCT03257358|144173627|OTHER|Estimation|least squares mean|-485.9|STANDARD_ERROR_OF_MEAN|91.88|||TWO_SIDED|95.0|-667.3|-304.4|||ANCOVA|||||-304.4|-667.3|
72325245|NCT03257358|144173628|OTHER|Estimation|least squares mean|-33.3|STANDARD_ERROR_OF_MEAN|7.47|||TWO_SIDED|95.0|-48.2|-18.5|||ANCOVA|||||-18.5|-48.2|
72325246|NCT03257358|144173628|OTHER|Estimation|least squares mean|-25.8|STANDARD_ERROR_OF_MEAN|5.52|||TWO_SIDED|95.0|-36.7|-14.9|||ANCOVA|||||-14.9|-36.7|
72325247|NCT03257358|144173629|OTHER|Estimation|least squares mean|-888.7|STANDARD_ERROR_OF_MEAN|13.1|||TWO_SIDED|95.0|-914.6|-862.7|||ANCOVA|||||-862.7|-914.6|
72325248|NCT03257358|144173629|OTHER|Estimation|least squares mean|-3.3|STANDARD_ERROR_OF_MEAN|7.24|||TWO_SIDED|95.0|-17.6|11.0|||ANCOVA|||||11.0|-17.6|
72325249|NCT03257358|144173630|OTHER|Estimation|least squares mean|-39.5|STANDARD_ERROR_OF_MEAN|1.053|||TWO_SIDED|95.0|-41.59|-37.42|||ANCOVA|||||-37.42|-41.59|
72325250|NCT03257358|144173630|OTHER|Estimation|least squares mean|0.14|STANDARD_ERROR_OF_MEAN|0.51|||TWO_SIDED|95.0|-0.87|1.14|||ANCOVA|||||1.14|-0.87|
72325251|NCT03257358|144173631|OTHER|Estimation|least squares mean|-248.9|STANDARD_ERROR_OF_MEAN|15.0|||TWO_SIDED|95.0|-278.7|-219.2|||ANCOVA|||||-219.2|-278.7|
72325252|NCT03257358|144173631|OTHER|Estimation|least squares mean|-9.9|STANDARD_ERROR_OF_MEAN|7.71|||TWO_SIDED|95.0|-25.1|5.4|||ANCOVA|||||5.4|-25.1|
72325253|NCT03257358|144173632|OTHER|Estimation|least squares mean|5.6|STANDARD_ERROR_OF_MEAN|1.249|||TWO_SIDED|95.0|3.13|8.08|||ANCOVA|||||8.08|3.13|
72325254|NCT03257358|144173632|OTHER|Estimation|least squares mean|0.04|STANDARD_ERROR_OF_MEAN|0.364|||TWO_SIDED|95.0|-0.68|0.76|||ANCOVA|||||0.76|-0.68|
72325255|NCT03257358|144173633|OTHER|Estimation|least squares mean|-231.0|STANDARD_ERROR_OF_MEAN|1.75|||TWO_SIDED|95.0|-234.5|-227.6|||ANCOVA|||||-227.6|-234.5|
72325256|NCT03257358|144173633|OTHER|Estimation|least squares mean|-0.3|STANDARD_ERROR_OF_MEAN|2.45|||TWO_SIDED|95.0|-5.2|4.5|||ANCOVA|||||4.5|-5.2|
72325257|NCT03257358|144173634|OTHER|Estimation|least squares mean|-8.3|STANDARD_ERROR_OF_MEAN|0.455|||TWO_SIDED|95.0|-9.21|-7.4|||ANCOVA|||||-7.40|-9.21|
72325258|NCT03257358|144173634|OTHER|Estimation|least squares mean|0.32|STANDARD_ERROR_OF_MEAN|0.251|||TWO_SIDED|95.0|-0.17|0.82|||ANCOVA|||||0.82|-0.17|
72416940|NCT00827918|144344704|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2||||0.8567|TWO_SIDED|95.0|-2.0|1.6|||Constrained longitudinal data analysis|||||1.6|-2.0|0.8567
72416941|NCT01751126|144344752|SUPERIORITY||LS Mean|0.76||||0.007|TWO_SIDED|95.0|0.26|1.27||ANCOVA with treatment as well as the baseline CFS and the exposure to Vernal keratoconjunctivitis (VKC) seasons (Hochberg procedure).|t-test, 2 sided|||||1.27|0.26|0.007
72607640|NCT05559905|144743459|SUPERIORITY||Difference in Percent (%)|-2.63|||||TWO_SIDED|95.0|-25.07|19.91||||||||19.91|-25.07|
72607641|NCT05559905|144743460|SUPERIORITY||Difference in Percent (%)|-16.18|||||TWO_SIDED|95.0|-36.77|5.64||||||||5.64|-36.77|
72325259|NCT01977898|144173668|SUPERIORITY|||||||0.877|||||||Fisher Exact|||A sample size of 65 patients in each group would be required to achieve 80% power to detect this difference between intrathecal morphine and saline administration . Sample size of 64 per group achieve 80% power to detect a difference between the group proportions of 0.25. The proportion in the treatment group is assumed to be 0.5 under the null hypothesis and 0.25 under the alternative hypothesis. The proportion in the control group is .05.The significance level of the test was targeted at .05.||||.877
72325260|NCT01977898|144173669|SUPERIORITY|||||||0.499|||||||Wilcoxon (Mann-Whitney)|||||||.499
72607642|NCT05559905|144743461|SUPERIORITY||Difference in Percent (%)|-2.89|||||TWO_SIDED|95.0|-25.69|19.37||||||||19.37|-25.69|
72607643|NCT05559905|144743462|SUPERIORITY||Difference in Least Squares Mean|-0.69||||0.253|TWO_SIDED|90.0|-1.68|0.31|||ANOVA|||Per protocol, only Panel B (treatment) and Panel C (placebo) are included in the model. For both panels, only the participants with RSV infection were included. The mean PVL in each group and the differences in mean PVL between MK-4482 and placebo and the corresponding 2- sided 95% CI were computed based on the linear model.||0.31|-1.68|0.253
72607644|NCT05559905|144743463|SUPERIORITY||Hazard Ratio (HR)|1.72||||0.1708||95.0|0.83|3.57|||Log Rank||Based on Cox regression model with Efron's method of tie handling with treatment as a covariate.|||3.57|0.83|0.1708
72607645|NCT05559905|144743464|SUPERIORITY||Difference in Least Squares Mean|-5.93||||0.257|TWO_SIDED|90.0|-14.61|2.75|||ANOVA|||Per protocol, only Panel B (treatment) and Panel C (placebo) are included in the model. For both panels, only the participants with RSV infection were included in the analysis. The mean VL-AUC in each group and the differences in mean VL-AUC between MK-4482 and placebo and the corresponding 2-sided 95% CI were computed based on the linear model.||2.75|-14.61|0.257
72607646|NCT05559905|144743465|SUPERIORITY||Difference in Least Squares Mean|-0.58||||0.453|TWO_SIDED|90.0|-1.88|0.71|||ANOVA|||Per protocol, only Panel B (treatment) and Panel C (placebo) are included in the model. For both panels, only the participants with RSV infection were included in the analysis. The mean PVL in each group and the differences in mean PVL between MK-4482 and placebo and the corresponding 2- sided 95% CI were computed based on the linear model.||0.71|-1.88|0.453
72607647|NCT05559905|144743466|SUPERIORITY||Hazard Ratio (HR)|1.06||||0.9121|TWO_SIDED|95.0|0.44|2.51|||Log Rank||Based on Cox regression model with Efron's method of tie handling with treatment as a covariate.|||2.51|0.44|0.9121
72607648|NCT05559905|144743467|SUPERIORITY||Difference in Least Squares Mean|-1.83||||0.377|TWO_SIDED|90.0|-5.25|1.6|||ANOVA|||Per protocol, only Panel B (treatment) and Panel C (placebo) were included in the model. The TSS-AUC in each group and the differences in mean TSS-AUC between MK-4482 and placebo and the corresponding 2- sided 95% CI were computed based on the linear model.||1.60|-5.25|0.377
72607649|NCT05559905|144743468|SUPERIORITY||Difference in Least Squares Mean|-0.13||||0.958|TWO_SIDED|90.0|-4.28|4.02|||ANOVA|||Per protocol, only Panel B (treatment) and Panel C (placebo) were included in the model. The TSS-AUC-CFB in each group and the differences in mean TSS-AUC-CFB between MK-4482 and placebo and the corresponding 2- sided 95% CI were computed based on the linear model.||4.02|-4.28|0.958
72607650|NCT05559905|144743469|SUPERIORITY||Difference in Least Squares Mean|-0.62||||0.52|TWO_SIDED|90.0|-2.21|0.98|||ANOVA|||Per protocol, only Panel B (treatment) and Panel C (placebo) are included in the model. For both panels, only the participants with RSV infection were included in the analysis. The mean peak TSS in each group and the differences in mean peak TSS between MK-4482 and placebo and the corresponding 2- sided 95% CI was computed based on the linear model.||0.98|-2.21|0.520
72607651|NCT05559905|144743471|SUPERIORITY||Hazard Ratio (HR)|2.24||||0.0459|TWO_SIDED|95.0|0.99|5.07|||Log Rank|Two-sided p-value based on log-rank test.|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate.|||5.07|0.99|0.0459
72607652|NCT03669588|144743496|SUPERIORITY||Odds Ratio (OR)|4.951|||<|0.0001|TWO_SIDED|95.0|2.213|11.528|||Regression, Logistic|||"Analysis with a 2-sided exact test (using logistic regression) at the 2-sided 5% significance level in the AChR-Ab seropositive population, stratified by Japanese versus (vs) non-Japanese and NSID vs no NSID as concomitant gMG treatment, with cycle baseline MG-ADL total score as covariate.~The treatment effect was presented as the odds ratio. An odds ratio of more than 1 represents a higher response rate for ARGX-113 compared to placebo."||11.528|2.213|<0.0001
72607653|NCT03669588|144743497|SUPERIORITY||Odds Ratio (OR)|10.842|||<|0.0001|TWO_SIDED|95.0|4.179|31.2|||Regression, Logistic|||"Analysis with a 2-sided exact test (using logistic regression) at the 2-sided 5% significance level in the AChR-Ab seropositive population, stratified by Japanese vs non-Japanese and NSID vs no NSID as concomitant gMG treatment, with cycle baseline QMG total score as covariate.~The treatment effect was presented as the odds ratio. An odds ratio of more than 1 represents a higher response rate for ARGX-113 compared to placebo."||31.200|4.179|<0.0001
72607654|NCT03669588|144743498|SUPERIORITY||Odds Ratio (OR)|3.699|||<|0.0001|TWO_SIDED|95.0|1.854|7.578|||Regression, Logistic|||"Analysis with a 2-sided exact test (using logistic regression) at the 2-sided 5% significance level in the overall population, stratified by AChR-Ab status (seropositive vs seronegative), Japanese vs non-Japanese and NSID vs no NSID as concomitant gMG treatment, with cycle baseline MG-ADL total score as covariate.~The treatment effect was presented as the odds ratio. An odds ratio of more than 1 represents a higher response rate for ARGX-113 compared to placebo."||7.578|1.854|<0.0001
72607655|NCT03669588|144743499|SUPERIORITY||Least square means difference|22.065|STANDARD_ERROR_OF_MEAN|5.616||0.0001|TWO_SIDED|95.0|10.949|33.181|||ANCOVA|||Analysis of covariance (ANCOVA) in the AChR-Ab seropositive population with treatment, baseline MG-ADL total score, Japanese vs non-Japanese, and NSID vs no NSID as concomitant gMG treatment as the covariates.||33.181|10.949|0.0001
72325261|NCT01977898|144173670|SUPERIORITY|||||||0.463|||||||Chi-squared|||||||.463
72325262|NCT01977898|144173671|SUPERIORITY|||||||0.0463|||||||Chi-squared|||||||.0463
72325263|NCT01977898|144173672|SUPERIORITY|||||||0.525|||||||Chi-squared|||||||.525
72325264|NCT01977898|144173673|SUPERIORITY|||||||0.691|||||||Wilcoxon (Mann-Whitney)|||||||0.691
72325265|NCT01977898|144173674|SUPERIORITY|||||||0.61|||||||Wilcoxon (Mann-Whitney)|||||||0.610
72325266|NCT01977898|144173675|SUPERIORITY|||||||0.499|||||||Wilcoxon (Mann-Whitney)|||||||.499
72325267|NCT01977898|144173676|SUPERIORITY|||||||0.06|||||||Wilcoxon (Mann-Whitney)|||||||.06
72325268|NCT01977898|144173677|SUPERIORITY|||||||0.31|||||||Wilcoxon (Mann-Whitney)|||||||.31
72325269|NCT02727322|144173683|SUPERIORITY||Risk Ratio (RR)|1.1||||0.97|TWO_SIDED|95.0|0.5|2.04|||Chi-squared|||||2.04|0.50|0.97
72416942|NCT01751126|144344752|SUPERIORITY||LS Mean|0.67||||0.01|TWO_SIDED|95.0|0.16|1.18|||ANCOVA|ANCOVA with treatment as well as the baseline CFS and the exposure to Vernal keratoconjunctivitis (VKC) seasons (Hochberg procedure).||||1.18|0.16|0.010
72325270|NCT02727322|144173684|SUPERIORITY||Risk Ratio (RR)|1.12||||0.665|TWO_SIDED|95.0|0.885|1.43|||Chi-squared|||||1.43|0.885|0.665
72607656|NCT03669588|144743500|SUPERIORITY|||||||0.2604|||||||Log Rank|||Analysis was performed in the AChR-Ab seropositive population and the p-value was calculated using the log-rank test, stratified by Japanese vs non-Japanese and NSID vs no NSID as concomitant gMG treatment.||||0.2604
72325271|NCT02727322|144173685|SUPERIORITY||Risk Ratio (RR)|1.32||||1|TWO_SIDED|95.0|0.31|5.68|||Fisher Exact|||||5.68|0.31|1.0
72325272|NCT01049373|144173701|SUPERIORITY_OR_OTHER|||||||0.0426|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0426
72607657|NCT01721447|144743502|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||< 0.001
72325273|NCT01049373|144173702|SUPERIORITY_OR_OTHER|||||||0.0757|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0757
72325274|NCT01049373|144173703|SUPERIORITY_OR_OTHER|||||||0.0465|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0465
72325275|NCT01049373|144173704|SUPERIORITY_OR_OTHER|||||||0.04443|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||0.04443
72325276|NCT00339040|144173717|SUPERIORITY_OR_OTHER_LEGACY|||||||1||95.0|||||Fisher Exact|||||||1.00
72607658|NCT01721447|144743503|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||< 0.001
72607659|NCT00369343|144743504|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.32|||<|0.001||95.0|2.53|6.11|||Mixed Models Analysis|Mixed Models Repeated Measures (MMRM) used baseline as a covariate and factors for center, week and treatment.|DVS SR adjusted mean change minus placebo adjusted mean change.|||6.11|2.53|<0.001
72607660|NCT00369343|144743505|SUPERIORITY_OR_OTHER||||||<|0.001||||||DVS SR compared to Placebo for CGI-I scores of either 1 (very much improved) or 2 (much improved).|Cochran-Mantel-Haenszel|||||||<0.001
72607661|NCT00369343|144743506|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.132||||0.008||95.0|1.22|3.74||DVS SR compared with Placebo.|Chi-squared|Logistic regression model with treatment and site as factors and baseline score as a covariate.|Adjusted odds ratio of DVS SR to Placebo. Odds ratio adjusted for baseline, treatment and site.|||3.74|1.22|0.008
72325277|NCT00988156|144173724|SUPERIORITY_OR_OTHER|||||||0.249|||||||ANCOVA|||||||0.2490
72325278|NCT00988156|144173725|SUPERIORITY_OR_OTHER|||||||0.9017|||||||Cochran-Mantel-Haenszel|||||||0.9017
72416943|NCT00785291|144344763|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.2||||0.054|TWO_SIDED|95.0|1.0|1.45||Tests were stratified by prior taxane therapy (yes/no) and hormone receptor status (positive/negative). P-values are for a test of inferiority 2-sided and are unadjusted for multiple comparisons.|Log Rank|||Stratified log-rank tests are used for the two primary comparisons of PFS within an experimental arm relative to PFS within the control arm. The family-wise error rate will be controlled at a one-sided 0.025 level. This is achieved in a 3-arm trial with a common control group by conducting the marginal log-rank tests with a one-sided α = 0.0135. Sample size calculations are based on having high power to detect a hazard ratio of 1.36, in the control arm as compared to the experimental arms.||1.45|1.00|0.054
72325279|NCT01815424|144173735|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|14.52|||<|0.0001|TWO_SIDED|95.0|6.03|32.77||Cochran-Mantel-Haenszel statistics adjusted for pooled investigator sites was used for the analysis. Each hypothesis was tested at a significance level of 0.05 (2-sided).|Cochran-Mantel-Haenszel|||For primary endpoint, step-down procedure used to preserve Type I error, sequential order of testing: PGA response for tofacitinib 10 mg vs placebo at Week 16; PASI75 response for tofacitinib 10 mg vs placebo at Week 16; PGA response for tofacitinib 5 mg vs placebo at Week 16; PASI75 response for tofacitinib 5 mg vs placebo at Week 16. If comparison at preceding step was significant, only then subsequent comparison was tested at the below specified significance level.||32.77|6.03|<0.0001
72607662|NCT00369343|144743507|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.125|||<|0.001||95.0|1.85|5.27||DVS SR compared with Placebo.|Chi-squared|Logistic regression model with treatment and site as factors and baseline score as a covariate.|Adjusted odds ratio of DVS SR to Placebo. Odd ratio adjusted for baseline, treatment and site.|||5.27|1.85|<0.001
72607663|NCT00369343|144743508|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.74|||<|0.001||95.0|1.24|4.23||Mixed model Repeated Measures (MMRM) analysis adjusted mean score for baseline score, time and center.|Mixed Models Analysis||Adjusted mean difference = Placebo adjusted mean score minus DVS SR adjusted mean score.|||4.23|1.24|<0.001
72607664|NCT00369343|144743509|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.12|||<|0.001||95.0|-0.18|-0.06||Mixed Model Repeated Measures (MMRM) with treatment and site as factors and baseline as covariate.|Mixed Models Analysis||Adjusted mean difference = Placebo adjusted mean score minus DVS SR adjusted mean score.|||-0.06|-0.18|<0.001
72607665|NCT00369343|144743516|SUPERIORITY_OR_OTHER|||||||0.553||||||t-test adjusted by multiple comparison|t-test, 2 sided|||100mg vs. Placebo (0mg) post taper||||0.553
72607666|NCT00369343|144743516|SUPERIORITY_OR_OTHER|||||||0.034||||||t-test adjusted by multiple comparison|t-test, 2 sided|||200mg vs. Placebo (0mg) post taper||||0.034
72607667|NCT01100502|144743517|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.57||||0.001|TWO_SIDED|95.0|0.4|0.81|||Log Rank|||||0.81|0.40|0.001
72607668|NCT02322749|144743521|NON_INFERIORITY_OR_EQUIVALENCE|If the 90% confidence intervals for both AUC and Cmax were entirely contained within the limits 80.00% to 125.00% then bioequivalence was concluded.|Geometric Least Squares (LS) Mean Ratio|9.32|||||TWO_SIDED|90.0|8.25|10.53|||||Selumetinib: Ratio of Treatment B to Treatment A based on a linear mixed-effects model with sequence, period, and treatment as fixed effects and volunteer nested within sequence as a random effect.|||10.53|8.25|
72607669|NCT02322749|144743522|NON_INFERIORITY_OR_EQUIVALENCE|If the 90% confidence intervals for both AUC and Cmax were entirely contained within the limits 80.00% to 125.00% then bioequivalence was concluded.|Geometric LS Mean Ratio|24.26|||||TWO_SIDED|90.0|22.62|26.03|||||Selumetinib: Ratio of Treatment B to Treatment A based on a linear mixed-effects model with sequence, period, and treatment as fixed effects and volunteer nested within sequence as a random effect.|||26.03|22.62|
72607670|NCT02322749|144743523|NON_INFERIORITY_OR_EQUIVALENCE|If the 90% confidence intervals for both AUC and Cmax were entirely contained within the limits 80.00% to 125.00% then bioequivalence was concluded.|Geometric LS mean ratio|22.12|||||TWO_SIDED|90.0|20.65|23.69|||||Selumetinib: Ratio of Treatment B to Treatment A based on a linear mixed-effects model with sequence, period, and treatment as fixed effects and volunteer nested within sequence as a random effect.|||23.69|20.65|
72607671|NCT02322749|144743524|SUPERIORITY_OR_OTHER||Geometric LS Mean Ratio|12.93|||||TWO_SIDED|90.0|11.42|14.65|||||Selumetinib: Ratio of Treatment C to Treatment A based on a linear mixed-effects model with sequence, period, and treatment as fixed effects and volunteer nested within sequence as a random effect.|||14.65|11.42|
72607672|NCT02322749|144743525|SUPERIORITY_OR_OTHER||Geometric LS Mean Ratio|26.2|||||TWO_SIDED|90.0|24.44|28.09|||||Selumetinib: Ratio of Treatment C to Treatment A based on a linear mixed-effects model with sequence, period, and treatment as fixed effects and volunteer nested within sequence as a random effect.|||28.09|24.44|
72607673|NCT02322749|144743526|SUPERIORITY_OR_OTHER||Geometric LS Mean Ratio|23.6|||||TWO_SIDED|90.0|22.02|25.3|||||Selumetinib: Ratio of Treatment C to Treatment A based on a linear mixed-effects model with sequence, period, and treatment as fixed effects and volunteer nested within sequence as a random effect.|||25.30|22.02|
72607674|NCT02322749|144743527|SUPERIORITY_OR_OTHER||Geometric LS Mean Ratio|9.66|||||TWO_SIDED|90.0|8.5|10.97|||||N-desmethyl selumetinib: Ratio of Treatment B to Treatment A based on a linear mixed-effects model with sequence, period, and treatment as fixed effects and volunteer nested within sequence as a random effect|||10.97|8.5|
72607675|NCT02322749|144743527|SUPERIORITY_OR_OTHER||Geometric LS Mean Ratio|13.04|||||TWO_SIDED|90.0|11.45|14.86|||||N-desmethyl selumetinib: Ratio of Treatment C to Treatment A based on a linear mixed-effects model with sequence, period, and treatment as fixed effects and volunteer nested within sequence as a random effect.|||14.86|11.45|
72607676|NCT02322749|144743528|SUPERIORITY_OR_OTHER||Geometric LS Mean Ratio|11.31|||||TWO_SIDED|90.0|9.8|13.05|||||N-desmethyl selumetinib: Ratio of Treatment B to Treatment A based on a linear mixed-effects model with sequence, period, and treatment as fixed effects and volunteer nested within sequence as a random effect.|||13.05|9.80|
72607677|NCT02322749|144743528|SUPERIORITY_OR_OTHER||Geometric LS Mean Ratio|12.8|||||TWO_SIDED|90.0|11.07|14.8|||||N-desmethyl selumetinib: Ratio of Treatment C to Treatment A based on a linear mixed-effects model with sequence, period, and treatment as fixed effects and volunteer nested within sequence as a random effect.|||14.80|11.07|
72607678|NCT01190813|144743534|SUPERIORITY_OR_OTHER||Percent Difference|11.0||||0.06|TWO_SIDED|95.0|-7.0|28.0|||Fisher Exact|It was not possible to adjust for baseline VA in these secondary analyses due to the small number of subjects meeting secondary outcome criteria.|Treatment group difference calculated as Levodopa - Placebo|A sample size of 129 participants provided 80% power with 1-sided type I error rate of 5% to reject the hypothesis of no difference between groups if the proportion improved was 30% in the levodopa group compared with 10% in the placebo group.||28|-7|0.06
72607679|NCT01190813|144743537|SUPERIORITY_OR_OTHER||Percent Difference|0.0|||||TWO_SIDED|95.0|-17.0|18.0|||||Levodopa - Placebo|||18|-17|
72607680|NCT01190813|144743538|SUPERIORITY_OR_OTHER||Percent Difference|-7.0|||||TWO_SIDED|95.0|-25.0|10.0||||||||10|-25|
72607681|NCT01190813|144743539|SUPERIORITY_OR_OTHER||Percent Difference|-5.0|||||TWO_SIDED|95.0|-22.0|13.0|||||Levodopa - Placebo|||13|-22|
72607682|NCT01190813|144743547|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.3||||0.65|TWO_SIDED|95.0|-1.9|1.3|||ANCOVA||Mean difference calculated as Levodopa - Placebo|||1.3|-1.9|0.65
72607683|NCT01190813|144743549|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.1||||0.44|TWO_SIDED|95.0|-1.6|1.8|||ANCOVA|||||1.8|-1.6|0.44
72607684|NCT01190813|144743551|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.9||||0.2|TWO_SIDED|95.0|-1.2|2.9|||ANCOVA|||||2.9|-1.2|0.20
72607685|NCT01190813|144743553|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.9||||0.17|TWO_SIDED||||||ANCOVA|||||||0.17
72607686|NCT01190813|144743557|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.4||||0.06|TWO_SIDED|95.0|-0.4|3.3||The alpha level was set to 0.0485 for the primary analysis to adjust for alpha spending of 0.015 for one interim analysis for efficacy conducted when outcome data were available for 50% of participants.|ANCOVA||Mean difference calculated as Levodopa - Placebo|With 129 participants, assuming a 1-sided type I error rate of 4.85%, there was 96% power to detect a difference in mean visual acuity between treatment groups at 18 weeks adjusted for baseline and for 1 interim analysis for futility if the true difference was 5 letters with SD of 7 letters and 82% power if the true difference was 3.75 letters||3.3|-0.4|0.06
72607687|NCT04414787|144743604|SUPERIORITY||Mean Difference (Final Values)|0.0||||1|TWO_SIDED|95.0|-6.21|6.21|||Mixed Models Analysis|||Difference between Time 1 (baseline) and Time 3 (\~1 week post-randomization)||6.21|-6.21|1.00
72607688|NCT04414787|144743605|SUPERIORITY||Mean Difference (Final Values)|-0.06||||0.95|TWO_SIDED|95.0|-1.83|1.72|||Mixed Models Analysis|||Difference between Time 1 (baseline) and Time 4 (3 months post-randomization)||1.72|-1.83|0.95
72607689|NCT04414787|144743606|SUPERIORITY||Mean Difference (Final Values)|0.29||||0.72|TWO_SIDED|95.0|-1.28|1.86|||Mixed Models Analysis|||Difference between Time 1 (baseline) and Time 4 (3 months post-randomization)||1.86|-1.28|0.72
72607690|NCT04414787|144743607|SUPERIORITY||Mean Difference (Final Values)|1.35||||0.48|TWO_SIDED|95.0|-2.44|5.14|||Mixed Models Analysis|||Difference between Time 1 (baseline) and Time 4 (3 months post-randomization)||5.14|-2.44|0.48
72607691|NCT04414787|144743608|SUPERIORITY||Odds Ratio (OR)|0.49||||0.12|TWO_SIDED|95.0|0.2|1.2|||Mixed Models Analysis|||Difference between Time 1 (baseline) and Time 3 (target \~1 week post-randomization)||1.2|0.20|0.12
72607692|NCT04414787|144743609|SUPERIORITY|||||||0.58|||||||Wilcoxon (Mann-Whitney)|||||||0.58
72607693|NCT04414787|144743610|SUPERIORITY|||||||0.29|||||||Wilcoxon (Mann-Whitney)|||||||0.29
72607694|NCT04414787|144743611|SUPERIORITY|||||||0.79|||||||Wilcoxon (Mann-Whitney)|||||||0.79
72607695|NCT02371616|144743674|NON_INFERIORITY|Inferences: upper end of the 2-sided 95% CI for the treatment difference for the estimated effect of Test relative to Comparator, for success, should be \<=6mm. (i.e., Test is no more than 6mm inferior to Comparator).|Least square (LS) mean difference|2.67||||0.2678|TWO_SIDED|95.0|-2.06|7.4||From ANCOVA model: change from baseline as the response variable, treatment group, baseline Schiff stratum and study site as fixed effects, with baseline VAS score as covariate.|ANCOVA||Difference is first named treatment minus second named dentifrice such that a negative difference favors the first named treatment.|Statistical analysis applies to change from baseline at week 8 for test and comparator dentifrice.||7.40|-2.06|0.2678
72607696|NCT00754741|144743678|SUPERIORITY_OR_OTHER|||||||0.763|TWO_SIDED||||||ANOVA|||||||0.763
72607697|NCT00754741|144743678|SUPERIORITY_OR_OTHER|||||||0.285|TWO_SIDED||||||ANOVA|||||||0.285
72607698|NCT00754741|144743679|SUPERIORITY_OR_OTHER|||||||0.38|TWO_SIDED||||||ANOVA|||||||0.380
72607699|NCT00754741|144743679|SUPERIORITY_OR_OTHER|||||||0.084|TWO_SIDED||||||ANOVA|||||||0.084
72607700|NCT00754741|144743680|SUPERIORITY_OR_OTHER|||||||0.667|TWO_SIDED||||||ANOVA|||||||0.667
72607701|NCT00754741|144743680|SUPERIORITY_OR_OTHER|||||||0.53|TWO_SIDED||||||ANOVA|||||||0.530
72607702|NCT00754741|144743681|SUPERIORITY_OR_OTHER|||||||0.881|TWO_SIDED||||||ANOVA|||||||0.881
72607703|NCT00754741|144743681|SUPERIORITY_OR_OTHER|||||||0.849|TWO_SIDED||||||ANOVA|||||||0.849
72607704|NCT00754741|144743682|SUPERIORITY_OR_OTHER|||||||0.134|TWO_SIDED||||||Chi-squared|||||||0.134
72607705|NCT00754741|144743682|SUPERIORITY_OR_OTHER|||||||0.714|TWO_SIDED||||||Chi-squared|||||||0.714
72607706|NCT00754741|144743683|SUPERIORITY_OR_OTHER|||||||0.291|TWO_SIDED||||||ANOVA|||||||0.291
72607707|NCT00754741|144743683|SUPERIORITY_OR_OTHER|||||||0.968|TWO_SIDED||||||ANOVA|||||||0.968
72607708|NCT00754741|144743684|SUPERIORITY_OR_OTHER|||||||0.671|TWO_SIDED||||||ANOVA|||||||0.671
72607709|NCT00754741|144743684|SUPERIORITY_OR_OTHER|||||||0.399|TWO_SIDED||||||ANOVA|||||||0.399
72607710|NCT00754741|144743685|SUPERIORITY_OR_OTHER|||||||0.829|TWO_SIDED||||||ANOVA|||||||0.829
72607711|NCT00754741|144743685|SUPERIORITY_OR_OTHER|||||||0.283|TWO_SIDED||||||ANOVA|||||||0.283
72607712|NCT00754741|144743686|SUPERIORITY_OR_OTHER|||||||0.971|TWO_SIDED||||||ANOVA|||||||0.971
72607713|NCT00754741|144743686|SUPERIORITY_OR_OTHER|||||||0.115|TWO_SIDED||||||ANOVA|||||||0.115
72607714|NCT00754741|144743687|SUPERIORITY_OR_OTHER|||||||0.573|TWO_SIDED||||||ANOVA|||||||0.573
72607715|NCT00754741|144743687|SUPERIORITY_OR_OTHER|||||||0.443|TWO_SIDED||||||ANOVA|||||||0.443
72607716|NCT00754741|144743688|SUPERIORITY_OR_OTHER|||||||0.469|TWO_SIDED||||||ANOVA|||||||0.469
72607717|NCT00754741|144743688|SUPERIORITY_OR_OTHER|||||||0.369|TWO_SIDED||||||ANOVA|||||||0.369
72607718|NCT00754741|144743689|SUPERIORITY_OR_OTHER|||||||0.779|TWO_SIDED||||||ANOVA|||||||0.779
72607719|NCT00754741|144743689|SUPERIORITY_OR_OTHER|||||||0.733|TWO_SIDED||||||ANOVA|||||||0.733
72607720|NCT00754741|144743690|SUPERIORITY_OR_OTHER|||||||0.952|TWO_SIDED||||||ANOVA|||||||0.952
72607721|NCT00754741|144743690|SUPERIORITY_OR_OTHER|||||||0.856|TWO_SIDED||||||ANOVA|||||||0.856
72607722|NCT00754741|144743691|SUPERIORITY_OR_OTHER|||||||0.419|TWO_SIDED||||||Chi-squared|||||||0.419
72607723|NCT00754741|144743691|SUPERIORITY_OR_OTHER|||||||0.998|TWO_SIDED||||||Chi-squared|||||||0.998
72607724|NCT03028142|144743692|OTHER||LS Means ratio|1.05||||0.0022|TWO_SIDED|95.0|1.02|1.09|||ANCOVA|||||1.09|1.02|0.0022
72607725|NCT03028142|144743692|OTHER||LS Means ratio|1.09|||<|0.0001|TWO_SIDED|95.0|1.05|1.12|||ANCOVA|||||1.12|1.05|<0.0001
72607726|NCT03028142|144743693|OTHER||LS Means ratio|1.03||||0.0988|TWO_SIDED|95.0|0.99|1.06|||ANCOVA|||||1.06|0.99|0.0988
72607727|NCT03028142|144743693|OTHER||LS Means ratio|1.06||||0.0009|TWO_SIDED|95.0|1.02|1.09|||ANCOVA|||||1.09|1.02|0.0009
72607728|NCT03028142|144743694|OTHER||LS Means ratio|1.02||||0.2496|TWO_SIDED|95.0|0.98|1.06|||ANCOVA|||||1.06|0.98|0.2496
72607729|NCT03028142|144743694|OTHER||LS Means ratio|1.06||||0.0039|TWO_SIDED|95.0|1.02|1.1|||ANCOVA|||||1.1|1.02|0.0039
72607730|NCT03028142|144743695|OTHER||LS Means ratio|1.03||||0.1404|TWO_SIDED|95.0|0.99|1.06|||ANCOVA|||||1.06|0.99|0.1404
72607731|NCT03028142|144743695|OTHER||LS Means ratio|1.04||||0.0228|TWO_SIDED|95.0|1.01|1.08|||ANCOVA|||||1.08|1.01|0.0228
72416944|NCT00785291|144344763|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.55|||<|0.0001|TWO_SIDED|95.0|1.28|1.87||Tests were stratified by prior taxane therapy (yes/no) and hormone receptor status (positive/negative). P-values are for a test of inferiority 2-sided and are unadjusted for multiple comparisons.|Log Rank|||Stratified log-rank tests are used for the two primary comparisons of PFS within an experimental arm relative to PFS within the control arm. The family-wise error rate will be controlled at a one-sided 0.025 level. This is achieved in a 3-arm trial with a common control group by conducting the marginal log-rank tests with a one-sided α = 0.0135. Sample size calculations are based on having high power to detect a hazard ratio of 1.36, in the control arm as compared to the experimental arms.||1.87|1.28|<0.0001
72416945|NCT00785291|144344767|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.17||||0.2|TWO_SIDED|95.0|0.92|1.47||Tests were stratified by prior taxane therapy (yes/no) and hormone receptor status (positive/negative).|Log Rank|||||1.47|0.92|0.20
72416946|NCT00785291|144344767|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.28||||0.038|TWO_SIDED|95.0|1.01|1.61||Tests were stratified by prior taxane therapy (yes/no) and hormone receptor status (positive/negative).|Log Rank|||||1.61|1.01|0.038
72607732|NCT01965327|144743741|SUPERIORITY_OR_OTHER_LEGACY|||||||0.027|TWO_SIDED||||||t-test, 2 sided|Missing data were imputed by last observation carried forward.||||||0.027
72607733|NCT01965327|144743742|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0078|TWO_SIDED||||||t-test, 2 sided|||||||0.0078
72607734|NCT01669434|144743745|SUPERIORITY||Risk Ratio (RR)|0.81||||0.03|TWO_SIDED|95.0|0.67|0.97|||Fisher Exact|||||0.97|0.67|0.03
72607735|NCT01669434|144743746|SUPERIORITY||Risk Ratio (RR)|0.6||||0.44|TWO_SIDED|95.0|0.23|1.6|||Fisher Exact|||||1.60|0.23|0.44
72607736|NCT01669434|144743747|SUPERIORITY||Risk Ratio (RR)|1.2||||1|TWO_SIDED|95.0|0.48|2.99|||Fisher Exact|||||2.99|0.48|1.0
72607737|NCT01669434|144743748|SUPERIORITY||Risk Ratio (RR)|1.01||||1|TWO_SIDED|95.0|0.81|1.26|||Fisher Exact|||||1.26|0.81|1.0
72607738|NCT01669434|144743749|SUPERIORITY||Risk Ratio (RR)|1.95||||0.01|TWO_SIDED|95.0|1.14|3.34|||Fisher Exact|||||3.34|1.14|0.01
72416947|NCT00570674|144344774|OTHER||||||<|0.01|||||||Sign test|||||||<0.01
72607739|NCT01669434|144743750|SUPERIORITY||Risk Ratio (RR)|0.49||||0.02|TWO_SIDED|95.0|0.28|0.86|||Fisher Exact|||||0.86|0.28|0.02
72607740|NCT02860988|144743761|OTHER|Two-sided tests versus a margin|Mean Difference (Net)|0.6||||0.29|TWO_SIDED|||||A priori threshold for statistical significance was set at 0.05.|Regression, Linear|||||||0.29
72607741|NCT02860988|144743762|OTHER|Two-sided tests versus a margin|Risk Difference (RD)|0.9||||0.88|TWO_SIDED|||||A priori threshold for statistical significance was set at 0.05.|Regression, Logistic|||||||0.88
72607742|NCT02860988|144743763|OTHER|Two-sided tests versus a margin.|Risk Difference (RD)|0.96||||0.89|TWO_SIDED|||||A priori threshold for statistical significance was set at 0.05.|Regression, Logistic|||||||0.89
72607743|NCT02860988|144743764|OTHER|Two-sided tests versus a margin.|Risk Difference (RD)|-4.26||||0.61|TWO_SIDED|||||A priori threshold for statistical significance was set at 0.05.|Regression, Logistic|||||||0.61
72607744|NCT02860988|144743765|OTHER|Two-sided tests versus a margin.|Risk Difference (RD)|3.61||||0.67|TWO_SIDED|||||A priori threshold for statistical significance was set at 0.05.|Regression, Logistic|||||||0.67
72607745|NCT02860988|144743766|OTHER|Two-sided tests versus a margin.|Risk Difference (RD)|5.23||||0.14|TWO_SIDED|||||A priori threshold for statistical significance was set at 0.05.|Regression, Logistic|||||||0.14
72607746|NCT02860988|144743767|OTHER|Two-sided tests versus a margin.|Mean Difference (Net)|0.03||||0.81|TWO_SIDED|||||A priori threshold for statistical significance was set at 0.05.|Regression, Linear|||||||0.81
72416948|NCT00570674|144344775|OTHER||||||<|0.01|||||||Sign test|||||||<0.01
72416949|NCT00570674|144344776|OTHER|||||||0.52|||||||Sign test|||||||0.52
72416950|NCT00570674|144344777|OTHER|||||||0.39|||||||Sign test|||||||0.39
72416951|NCT01466985|144344811|SUPERIORITY|Doravirine was declared superior to placebo when the upper bound of the 90% CI was \<-1.|Least squares (LS) mean difference|-1.37|||<|0.001||90.0|-1.6|-1.02|||ANCOVA|||||-1.02|-1.60|<0.001
72416952|NCT01466985|144344811|SUPERIORITY|Doravirine was declared superior to placebo when the upper bound of the 90% CI was \<-1.|LS mean difference|-1.26|||<|0.001|TWO_SIDED|90.0|-1.51|-1.02|||ANCOVA|||||-1.02|-1.51|<0.001
72416953|NCT05616962|144344816|SUPERIORITY|||||||0.473|||||||ANCOVA|Repeated measures ANCOVA with baseline value as covariate including the changes from Baseline to months 1, 2, and 3||||||0.473
72416954|NCT05616962|144344817|SUPERIORITY|||||||0.03199|||||||paired t-test|||||||0.03199
72416955|NCT05616962|144344818|SUPERIORITY|||||||0.408|||||||ANCOVA|ANCOVA with baseline value as covariate||||||0.408
72416956|NCT05616962|144344819|SUPERIORITY||||||<|0.001||||||"Reported p-value was calculated, did not attempt to indicate threshold for statistical significance. Significance was evaluated at \<0.05. P-values were reported to the thousandths place and those less than 0.001 were reported as \<0.001."|ANCOVA|Repeated measures ANCOVA with baseline value as covariate including the changes from Baseline to months 1, 2, and 3||||||<0.001
72607747|NCT02860988|144743768|OTHER|Two-sided tests versus a margin.|Mean Difference (Net)|0.31||||0.74|TWO_SIDED|||||A priori threshold for statistical significance was set at 0.05.|Regression, Linear|||||||0.74
72607748|NCT01868646|144743804|SUPERIORITY|||||||0.0002||||||"The p-value associated with treatment factor of changes from baseline to Week 12, 24 and 36 endpoint between Subetta and Placebo treatment groups. Model includes treatment, visit and treatment\*visit interaction."|Mixed Models Analysis|||||||0.0002
72607749|NCT01868646|144743805|SUPERIORITY|||||||0.0426||||||"The p-value associated with treatment factor of changes from baseline to Week 4, 12, 24 and 36 endpoint between Subetta and Placebo treatment groups. Model includes treatment, visit and treatment\*visit interaction."|Mixed Models Analysis|||||||0.0426
72607750|NCT01868646|144743806|SUPERIORITY|||||||0.599||||||"The p-value associated with treatment factor of changes from baseline to Week 4, 8, 12, 18, 24, 30 and 36 endpoint between Subetta and Placebo treatment groups. Model includes treatment, visit and treatment\*visit interaction."|Mixed Models Analysis|||||||0.5990
72607751|NCT01868646|144743807|SUPERIORITY|||||||0.6215||||||"The p-value associated with treatment factor of mean value at baseline to Week 12, 24 and 36 endpoint between Subetta and Placebo treatment groups. Model includes treatment, visit and treatment\*visit interaction."|Mixed Models Analysis|||||||0.6215
72607752|NCT01868646|144743808|SUPERIORITY|||||||0.6155||||||"The p-value associated with treatment factor of changes from baseline to Week 12, 24 and 36 endpoint between Subetta and Placebo treatment groups. Model includes treatment, visit and treatment\*visit interaction."|Mixed Models Analysis|||Analysis of Total cholesterol changes from baseline to Week 12, 24 and 36 endpoint between Subetta and Placebo treatment groups.||||0.6155
72607753|NCT01868646|144743808|SUPERIORITY|||||||0.7507||||||"The p-value associated with treatment factor of changes from baseline to Week 12, 24 and 36 endpoint between Subetta and Placebo treatment groups. Model includes treatment, visit and treatment\*visit interaction."|Mixed Models Analysis|||Analysis of HDL cholesterol changes from baseline to Week 12, 24 and 36 endpoint between Subetta and Placebo treatment groups.||||0.7507
72607754|NCT01868646|144743808|SUPERIORITY|||||||0.4195||||||"The p-value associated with treatment factor of changes from baseline to Week 12, 24 and 36 endpoint between Subetta and Placebo treatment groups. Model includes treatment, visit and treatment\*visit interaction."|Mixed Models Analysis|||Analysis of LDL cholesterol changes from baseline to Week 12, 24 and 36 endpoint between Subetta and Placebo treatment groups.||||0.4195
72607755|NCT01868646|144743808|SUPERIORITY|||||||0.3609||||||"The p-value associated with treatment factor of changes from baseline to Week 12, 24 and 36 endpoint between Subetta and Placebo treatment groups. Model includes treatment, visit and treatment\*visit interaction."|Mixed Models Analysis|||Analysis of Triglycerides changes from baseline to Week 12, 24 and 36 endpoint between Subetta and Placebo treatment groups.||||0.3609
72607756|NCT01868646|144743809|SUPERIORITY|||||||0.0605|||||||t-test, 2 sided|||||||0.0605
72607757|NCT01868646|144743810|SUPERIORITY|||||||0.0726|||||||t-test, 2 sided|||||||0.0726
72607758|NCT01868646|144743811|SUPERIORITY|||||||0.3108|||||||Fisher Exact|||||||0.3108
72607759|NCT01868646|144743812|SUPERIORITY|||||||0.2934|||||||t-test, 2 sided|||||||0.2934
72607760|NCT01868646|144743813|SUPERIORITY|||||||0.341|||||||t-test, 2 sided|||||||0.3410
72607761|NCT01868646|144743814|SUPERIORITY|||||||0.1577|||||||t-test, 2 sided|||Satisfaction||||0.1577
72607762|NCT01868646|144743814|SUPERIORITY|||||||0.5262|||||||t-test, 2 sided|||Hyperglycemia||||0.5262
72607763|NCT01868646|144743814|SUPERIORITY|||||||0.7417|||||||t-test, 2 sided|||Hypoglycemia||||0.7417
72607764|NCT03191799|144743846|SUPERIORITY||||||<|0.0001|||||||Paired t-test|||Month 3 vs. Baseline||||<0.0001
72607765|NCT03191799|144743846|SUPERIORITY||||||<|0.0001|||||||Paired t-test|||Month 6 vs. Baseline||||<0.0001
72607766|NCT03191799|144743846|SUPERIORITY||||||<|0.0001|||||||Paired t-test|||Month 12 vs. Baseline||||<0.0001
72607767|NCT03191799|144743846|SUPERIORITY||||||<|0.0001|||||||Paired t-test|||Month 18 vs. Baseline||||<0.0001
72607768|NCT03191799|144743846|SUPERIORITY||||||<|0.0001|||||||Paired t-test|||Early Terminatinon/Study Completion vs. Baseline||||<0.0001
72607769|NCT03191799|144743848|SUPERIORITY||||||<|0.0001|||||||Paired t-test|||Month 3 vs. Baseline||||<0.0001
72607770|NCT03191799|144743848|SUPERIORITY||||||<|0.0001|||||||Paired t-test|||Month 6 vs. Baseline||||<0.0001
72607771|NCT03191799|144743848|SUPERIORITY||||||<|0.0001|||||||Paired t-test|||Month 12 vs. Baseline||||<0.0001
72607772|NCT03191799|144743848|SUPERIORITY||||||<|0.0001|||||||Paired t-test|||Month 18 vs. Baseline||||<0.0001
72607773|NCT03191799|144743848|SUPERIORITY||||||<|0.0001|||||||Paired t-test|||Early Terminatinon/Study Completion vs. Baseline||||<0.0001
72607774|NCT03191799|144743859|SUPERIORITY|||||||0.0001|||||||Paired t-test|||Month 3 vs. Baseline||||0.0001
72607775|NCT03191799|144743859|SUPERIORITY||||||<|0.0001|||||||Paired t-test|||Month 6 vs. Baseline||||<0.0001
72607776|NCT03191799|144743859|SUPERIORITY||||||<|0.0001|||||||Paired t-test|||Month 12 vs. Baseline||||<0.0001
72607777|NCT03191799|144743859|SUPERIORITY||||||<|0.0001|||||||Paired t-test|||Month 18 vs. Baseline||||<0.0001
72607778|NCT03191799|144743859|SUPERIORITY|||||||0.0004|||||||Paired t-test|||Early Terminatinon/Study Completion vs. Baseline||||0.0004
72607779|NCT03191799|144743861|SUPERIORITY||||||<|0.0001|||||||Paired t-test|||Month 3 vs. Baseline||||<0.0001
72607780|NCT03191799|144743861|SUPERIORITY||||||<|0.0001|||||||Paired t-test|||Month 6 vs. Baseline||||<0.0001
72607781|NCT03191799|144743861|SUPERIORITY||||||<|0.0001|||||||Paired t-test|||Month 12 vs. Baseline||||<0.0001
72607782|NCT03191799|144743861|SUPERIORITY||||||<|0.0001|||||||Paired t-test|||Month 18 vs. Baseline||||<0.0001
72607783|NCT03191799|144743861|SUPERIORITY||||||<|0.0001|||||||Paired t-test|||Early Terminatinon/Study Completion vs. Baseline||||<0.0001
72607784|NCT03191799|144743871|SUPERIORITY||||||<|0.0001|||||||Paired t-test|||Month 3 vs. Baseline||||<0.0001
72607785|NCT03191799|144743871|SUPERIORITY||||||<|0.0001|||||||Paired t-test|||Month 6 vs. Baseline||||<0.0001
72607786|NCT03191799|144743871|SUPERIORITY||||||<|0.0001|||||||Paired t-test|||Month 12 vs. Baseline||||<0.0001
72607787|NCT03191799|144743871|SUPERIORITY||||||<|0.0001|||||||Paired t-test|||Month 18 vs. Baseline||||<0.0001
72607788|NCT03191799|144743871|SUPERIORITY||||||<|0.0001|||||||Paired t-test|||Early Terminatinon/Study Completion vs. Baseline||||<0.0001
72607789|NCT03191799|144743872|SUPERIORITY||||||<|0.0001|||||||Paired t-test|||Month 3 vs. Baseline||||<0.0001
72607790|NCT03191799|144743872|SUPERIORITY||||||<|0.0001|||||||Paired t-test|||Month 6 vs. Baseline||||<0.0001
72607791|NCT03191799|144743872|SUPERIORITY||||||<|0.0001|||||||Paired t-test|||Month 12 vs. Baseline||||<0.0001
72607792|NCT03191799|144743872|SUPERIORITY||||||<|0.0001|||||||Paired t-test|||Month 18 vs. Baseline||||<0.0001
72607793|NCT03191799|144743872|SUPERIORITY||||||<|0.0001|||||||Paired t-test|||Early Terminatinon/Study Completion vs. Baseline||||<0.0001
72607794|NCT01663402|144743951|SUPERIORITY||Hazard Ratio (HR)|0.85||||0.0003|TWO_SIDED|95.0|0.78|0.93||Threshold for statistical significance at 0.0498 level.|Log Rank|||Analysis was performed using Cox proportional hazard model and log rank test stratified on geographical region (North America, South America, Western Europe, Eastern Europe, Asia, Rest of the world).||0.93|0.78|0.0003
72416957|NCT05616962|144344820|SUPERIORITY||||||<|0.001||||||"Reported p-value was calculated, did not attempt to indicate threshold for statistical significance. Significance was evaluated at \<0.05. P-values were reported to the thousandths place and those less than 0.001 were reported as \<0.001."|ANCOVA|Repeated measures ANCOVA with baseline value as covariate including the changes from Baseline to months 1, 2, and 3||||||<0.001
72607795|NCT01663402|144743952|SUPERIORITY||Hazard Ratio (HR)|0.88||||0.0013|TWO_SIDED|95.0|0.81|0.95||Threshold for statistical significance at 0.0498 level.|Log Rank|||Analysis was performed using Cox proportional hazard model and log rank test stratified on geographical region(North America,South America,Western Europe,Eastern Europe,Asia, Rest of the world).A hierarchical testing approach was used to control the overall type-I error at 0.0249 one-sided alpha level(0.0498 two-sided).Testing was then performed sequentially in the order endpoints were reported.Hierarchical testing sequence continued only if the previous endpoint was statistically significant.||0.95|0.81|0.0013
72607796|NCT01663402|144743953|SUPERIORITY||Hazard Ratio (HR)|0.88||||0.006|TWO_SIDED|95.0|0.8|0.96||Threshold for statistical significance at 0.0498 level.|Log Rank|||Analysis was performed using Cox proportional hazard model and log rank test stratified on geographical region (North America, South America, Western Europe, Eastern Europe, Asia, Rest of the world). Testing was performed according to the hierarchical testing procedure (continued only if the previous endpoint was statistically significant).||0.96|0.80|0.0060
72607797|NCT01663402|144743954|SUPERIORITY||Hazard Ratio (HR)|0.87||||0.0003|TWO_SIDED|95.0|0.81|0.94||Threshold for statistical significance at 0.0498 level.|Log Rank|||Analysis was performed using Cox proportional hazard model and log rank test stratified on geographical region (North America, South America, Western Europe, Eastern Europe, Asia, Rest of the world). Testing according to the hierarchical testing procedure (continued only if the previous endpoint was statistically significant).||0.94|0.81|0.0003
72607798|NCT01663402|144743955|SUPERIORITY||Hazard Ratio (HR)|0.86||||0.0003|TWO_SIDED|95.0|0.79|0.93||Threshold for statistical significance at 0.0498 level.|Log Rank|||Analysis was performed using Cox proportional hazard model and log rank test stratified on geographical region (North America, South America, Western Europe, Eastern Europe, Asia, Rest of the world). Testing according to the hierarchical testing procedure (continued only if the previous endpoint was statistically significant).||0.93|0.79|0.0003
72607799|NCT01663402|144743956|SUPERIORITY||Hazard Ratio (HR)|0.92||||0.3824|TWO_SIDED|95.0|0.76|1.11||Threshold for statistical significance at 0.0498 level.|Log Rank|||Analysis was performed using Cox proportional hazard model and log rank test stratified on geographical region (North America, South America, Western Europe, Eastern Europe, Asia, Rest of the world). Testing according to the hierarchical testing procedure (continued only if the previous endpoint was statistically significant).||1.11|0.76|0.3824
72607800|NCT02240667|144744070|OTHER|||||||0.8496|||||||stratified log-rank test|||Persistence in both treatment groups was compared by means of the stratified Log-rank test||||0.8496
72416958|NCT05616962|144344821|SUPERIORITY||||||<|0.001||||||"Reported p-value was calculated, did not attempt to indicate threshold for statistical significance. Significance was evaluated at \<0.05. P-values were reported to the thousandths place and those less than 0.001 were reported as \<0.001."|ANCOVA|Repeated measures ANCOVA with baseline value as covariate including the changes from Baseline to months 1, 2, and 3||||||<0.001
72607801|NCT04613518|144744112|SUPERIORITY||Mean Difference (Final Values)|3.8|||||TWO_SIDED|95.0|-35.7|43.4||||||||43.4|-35.7|
72607802|NCT00791999|144744129|SUPERIORITY_OR_OTHER||||||<|0.025||95.0||||Wald p-values(vs. placebo) for the comparison of the treatment groups have been calculated using logistic regression with factors for treatment.|Regression, Logistic|||For ACR20 responder rate at Week 12, treatment comparisons versus placebo for the two CDP870 dose groups, the CDP870 200 mg group the CDP870 400 mg, were performed. The ACR20 responder rate in the CDP870 100 mg group was used for the secondary analysis.||||<0.025
72607803|NCT00791999|144744130|SUPERIORITY_OR_OTHER||||||<|0.05||95.0||||Wald p-values(vs. placebo) for the comparison of the treatment groups have been calculated using logistic regression with factors for treatment.|Regression, Logistic|||||||<0.05
72607804|NCT01077323|144744131|SUPERIORITY_OR_OTHER||Adjusted Rate Ratio (ARR)|0.87|||||TWO_SIDED|95.0|0.59|1.28|||||"ARR equals adjusted incidence rate of acute pancreatitis in exenatide cohort divided by adjusted incidence of acute pancreatitis in OAD cohort.~Adjusted incidence rates were calculated using a Poisson regression model adjusted for propensity score."|||1.28|0.59|
72607805|NCT01077323|144744132|SUPERIORITY_OR_OTHER||Adjusted Rate Ratio (ARR)|1.1|||||TWO_SIDED|95.0|0.8|1.5|||||ARR equals adjusted incidence rate of acute pancreatitis in exenatide cohort divided by adjusted incidence of acute pancreatitis in OAD cohort.Rate ratios adjusted for propensity score of exenatide initiation using Cox Proportional Hazards Regression|||1.5|0.8|
72607806|NCT01077323|144744133|SUPERIORITY_OR_OTHER||Adjusted Rate Ratio (ARR)|0.87|||||TWO_SIDED|95.0|0.36|2.09|||||"ARR equals adjusted incidence rate of acute pancreatitis in exenatide cohort divided by adjusted incidence of acute pancreatitis in OAD cohort.~Adjusted incidence rates were calculated using a Poisson regression model adjusted for propensity score."|||2.09|0.36|
72607807|NCT01077323|144744134|SUPERIORITY_OR_OTHER||Adjusted Rate Ratio (ARR)|1.39|||||TWO_SIDED|95.0|0.86|2.25|||||"ARR equals adjusted incidence rate of acute pancreatitis in exenatide cohort divided by adjusted incidence of acute pancreatitis in OAD cohort.~Adjusted incidence rates were calculated using a Poisson regression model adjusted for propensity score."|||2.25|0.86|
72416959|NCT05616962|144344822|SUPERIORITY||||||<|0.001||||||"Reported p-value was calculated, did not attempt to indicate threshold for statistical significance. Significance was evaluated at \<0.05. P-values were reported to the thousandths place and those less than 0.001 were reported as \<0.001."|ANCOVA|Repeated measures ANCOVA with baseline value as covariate including the changes from Baseline to months 1, 2, and 3||||||<0.001
72416960|NCT05616962|144344823|SUPERIORITY||||||<|0.001||||||"Reported p-value was calculated, did not attempt to indicate threshold for statistical significance. Significance was evaluated at \<0.05. P-values were reported to the thousandths place and those less than 0.001 were reported as \<0.001."|ANCOVA|Repeated measures ANCOVA with baseline value as covariate including the changes from Baseline to months 1, 2, and 3||||||<0.001
72607808|NCT00427908|144744135|NON_INFERIORITY|Criterion indicative of non-inferiority: lower limit of the standardized asymptotic 95% confidence interval (CI) for the group difference (Nimenrix minus Mencevax) in the percentage of subjects with bactericidal vaccine response to be greater than or equal to -15% for rSBA-MenA.|Difference in percentage|6.44|||||TWO_SIDED|95.0|1.15|16.04||||||To evaluate the non-inferiority of Nimenrix™ conjugate vaccine compared to Mencevax™ plain polysaccharide vaccine in terms of the vaccine response (VRR) to MenA. Response to a vaccine antigen component was defined as: For initially seronegative subject, post-vaccination serum bactericidal assay using rabbit complement (rSBA) titer ≥ 1:32. For initially seropositive subject, at least 4-fold increase in rSBA-MenA titer from pre to post vaccination.||16.04|1.15|
72416961|NCT05616962|144344824|SUPERIORITY||||||<|0.001||||||"Reported p-value was calculated, did not attempt to indicate threshold for statistical significance. Significance was evaluated at \<0.05. P-values were reported to the thousandths place and those less than 0.001 were reported as \<0.001."|ANCOVA|Repeated measures ANCOVA with baseline value as covariate including the changes from Baseline to months 1, 2, and 3||||||<0.001
72416962|NCT05616962|144344825|SUPERIORITY||||||<|0.001||||||"Reported p-value was calculated, did not attempt to indicate threshold for statistical significance. Significance was evaluated at \<0.05. P-values were reported to the thousandths place and those less than 0.001 were reported as \<0.001."|ANCOVA|Repeated measures ANCOVA with baseline value as covariate including the changes from Baseline to months 1, 2, and 3||||||<0.001
72416963|NCT05616962|144344826|SUPERIORITY||||||<|0.001||||||"Reported p-value was calculated, did not attempt to indicate threshold for statistical significance. Significance was evaluated at \<0.05. P-values were reported to the thousandths place and those less than 0.001 were reported as \<0.001."|ANCOVA|Repeated measures ANCOVA with baseline value as covariate including the changes from Baseline to months 1, 2, and 3||||||<0.001
72416964|NCT05616962|144344827|SUPERIORITY||||||<|0.001||||||"Reported p-value was calculated, did not attempt to indicate threshold for statistical significance. Significance was evaluated at \<0.05. P-values were reported to the thousandths place and those less than 0.001 were reported as \<0.001."|ANCOVA|Repeated measures ANCOVA with baseline value as covariate including the changes from Baseline to months 1, 2, and 3||||||<0.001
72416965|NCT05616962|144344828|SUPERIORITY||||||<|0.001||||||"Reported p-value was calculated, did not attempt to indicate threshold for statistical significance. Significance was evaluated at \<0.05. P-values were reported to the thousandths place and those less than 0.001 were reported as \<0.001."|ANCOVA|Repeated measures ANCOVA with baseline value as covariate including the changes from Baseline to months 1, 2, and 3||||||<0.001
72416966|NCT05616962|144344829|SUPERIORITY||||||<|0.001||||||"Reported p-value was calculated, did not attempt to indicate threshold for statistical significance. Significance was evaluated at \<0.05. P-values were reported to the thousandths place and those less than 0.001 were reported as \<0.001."|ANCOVA|Repeated measures ANCOVA with baseline value as covariate including the changes from Baseline to months 1, 2, and 3||||||<0.001
72416967|NCT05616962|144344830|SUPERIORITY||||||<|0.001||||||"Reported p-value was calculated, did not attempt to indicate threshold for statistical significance. Significance was evaluated at \<0.05. P-values were reported to the thousandths place and those less than 0.001 were reported as \<0.001."|ANCOVA|Repeated measures ANCOVA with baseline value as covariate including the changes from Baseline to months 1, 2, and 3||||||<0.001
72416968|NCT05616962|144344831|SUPERIORITY||||||<|0.001||||||"Reported p-value was calculated, did not attempt to indicate threshold for statistical significance. Significance was evaluated at \<0.05. P-values were reported to the thousandths place and those less than 0.001 were reported as \<0.001."|ANCOVA|Repeated measures ANCOVA with baseline value as covariate including the changes from Baseline to months 1, 2, and 3||||||<0.001
72416969|NCT05616962|144344832|SUPERIORITY||||||<|0.001||||||"Reported p-value was calculated, did not attempt to indicate threshold for statistical significance. Significance was evaluated at \<0.05. P-values were reported to the thousandths place and those less than 0.001 were reported as \<0.001."|ANCOVA|Repeated measures ANCOVA with baseline value as covariate including the changes from Baseline to months 1, 2, and 3||||||<0.001
72416970|NCT05616962|144344834|SUPERIORITY|||||||0.00463|||||||paired t-test|||||||0.00463
72416971|NCT05616962|144344835|SUPERIORITY|||||||0.23077|||||||paired t-test|||||||0.23077
72607809|NCT00427908|144744135|NON_INFERIORITY|Criterion indicative of non-inferiority: lower limit of the standardized asymptotic 95% confidence interval (CI) for the group difference (Nimenrix minus Mencevax) in the percentage of subjects with bactericidal vaccine response is greater than or equal to -15% for rSBA-MenC.|Difference in percentage|13.18|||||TWO_SIDED|95.0|4.79|24.32||||||To evaluate the non-inferiority of Nimenrix™ conjugate vaccine compared to Mencevax™ plain polysaccharide vaccine in terms of the vaccine response (VRR) to MenC. Response to a vaccine antigen component was defined as: For initially seronegative subject, post-vaccination serum bactericidal assay using rabbit complement (rSBA) titer ≥ 1:32. For initially seropositive subject, at least 4-fold increase in rSBA-MenC titer from pre to post vaccination.||24.32|4.79|
72416972|NCT05616962|144344836|SUPERIORITY|||||||0.00849|||||||paired t-test|||||||0.00849
72416973|NCT00483184|144344858|SUPERIORITY_OR_OTHER|||||||0.404||95.0|||||ANOVA|||Results were expressed as mean or number. Normal distributed data among the treatment groups were compared by One-way ANOVA test, non-normal distributed data were compared by Kruskal Wallis test, and then Bonferroni post-hoc test was used for multiple comparisons. Differences from baseline within treatment groups were evaluated by repeated measures ANOVA test for normal distributed data, Freidman test for non-normal distributed data.||||0.404
72416974|NCT00558428|144344860|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-3.64|STANDARD_ERROR_OF_MEAN|0.64|<|0.0001||95.0|-4.9|-2.38|||ANCOVA|Adjusted for baseline and country effect||||-2.38|-4.90|<0.0001
72416975|NCT00558428|144344860|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-4.92|STANDARD_ERROR_OF_MEAN|0.64|<|0.0001||95.0|-6.18|-3.66|||ANCOVA|Adjusted for baseline and country effect||||-3.66|-6.18|<0.0001
72416976|NCT00558428|144344860|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-1.4|STANDARD_ERROR_OF_MEAN|0.64||||95.0|-2.66|-0.14|||ANCOVA|Adjusted for baseline and country effect||||-0.14|-2.66|
72416977|NCT00558428|144344860|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-2.68|STANDARD_ERROR_OF_MEAN|0.64||||95.0|-3.93|-1.43|||ANCOVA|Adjusted for baseline and country effect||||-1.43|-3.93|
72416978|NCT05224050|144344884|OTHER|A paired-samples t-test was conducted to examine differences in the DASS-21 total score from baseline to 2-weeks post-quit.|Mean Difference (Final Values)|-2.04|STANDARD_DEVIATION|10.54||0.4|TWO_SIDED|95.0|-6.98|2.89||The threshold for statistical significance was p\<0.05|t-test, 2 sided||Mean difference represents the difference of the mean for the DASS-21 total scores at Baseline and at 2-weeks post-quit. The reported estimated value is based on data from the n=20 who attended their 2-weeks post-quit session|||2.89|-6.98|0.40
72416979|NCT05224050|144344884|OTHER|A paired-samples t-test was conducted to examine the difference in the DASS-21 total scores from 2-weeks post-quit to 1-month post-quit.|Mean Difference (Final Values)|-2.43|STANDARD_DEVIATION|9.15||0.26|TWO_SIDED|95.0|-6.84|1.98||The threshold for statistical significance was p \< 0.05.|t-test, 2 sided||Mean difference represents the difference of mean DASS-21 total scores at 2-weeks post-quit and 1-month post-quit. The reported estimated value is based on data from the n=19 participants who attended their 1-month post-quit session.|||1.98|-6.84|0.26
72416980|NCT05224050|144344884|OTHER|A paired-samples t-test was conducted to examine the difference in the DASS-21 total scores from 1-month post-quit to 3-month follow up.|Mean Difference (Final Values)|-2.75|STANDARD_DEVIATION|6.49||0.11|TWO_SIDED|95.0|-6.21|0.71||The threshold for statistical significance was p \< 0.05.|t-test, 2 sided||Mean difference represents the difference of mean DASS-21 total scores at 1-month post-quit and 3-month follow up. The reported estimated value is based on data from the n=16 participants who attended their 3-month follow up session.|||0.71|-6.21|0.11
72416981|NCT05224050|144344887|OTHER|A paired-samples t-test was conducted to compare changes in cigarettes smoked per day from Baseline to Quit Day.|Mean Difference (Final Values)|13.7|STANDARD_DEVIATION|8.63|<|0.001|TWO_SIDED|95.0|9.88|17.53||The threshold for statistical significance was p \< 0.05.|t-test, 2 sided||Mean difference represents the average difference in cigarettes smoked per day from Baseline to Quit Date. The reported estimated value is based on data from the n=22 participants who attended their Quit Date session.|||17.53|9.88|<0.001
72416982|NCT05224050|144344887|OTHER|A paired-samples t-test was used to evaluate smoking reduction in participants from Quit Date to 2-weeks Post-Quit.|Mean Difference (Final Values)|0.11|STANDARD_DEVIATION|2.02||0.8|TWO_SIDED|95.0|-0.83|1.06||The threshold for statistical significance was p \< 0.05.|t-test, 2 sided||Mean difference represents the average difference in cigarettes smoked per day from Quit Date to 2-weeks Post-Quit. The reported estimated value is based on data from the n=20 participants who attended their 2-weeks post-quit session.|||1.06|-0.83|0.80
72416983|NCT05224050|144344887|OTHER|A paired-samples t-test was used to evaluate smoking reduction in participants from 2-weeks post-quit to 1=month post-quit.|Mean Difference (Final Values)|0.02|STANDARD_DEVIATION|2.97||0.97|TWO_SIDED|95.0|-1.41|1.45||The threshold for statistical significance was p \< 0.05.|t-test, 2 sided||Mean difference represents the average difference in cigarettes smoked per day from 2-weeks post-quit to 1-month post-quit. The reported estimated value is based on data from the n=19 participants who attended their 1-month post-quit session.|||1.45|-1.41|0.97
72416984|NCT05224050|144344887|OTHER|A paired-samples t-test was used to evaluate smoking reduction in participants from 1-month post-quit to 3-month follow-up.|Mean Difference (Final Values)|-2.17|STANDARD_DEVIATION|3.75||0.04|TWO_SIDED|95.0|-4.17|-0.17||The threshold for statistical significance was p \< 0.05.|t-test, 2 sided||Mean difference represents the average difference in cigarettes smoked per day from 1-month post-quit to 3-month follow-up. The reported estimated value is based on data from the n=16 participants who attended their 3-month follow-up session.|||-0.17|-4.17|0.04
72416985|NCT01627327|144344890|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.022||||0.201|TWO_SIDED|95.0|-0.012|0.055|||ANCOVA|||||0.055|-0.012|0.201
72416986|NCT01175850|144344894|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Z-test|Z-test of two proportions was used to compare treatment groups for all randomized subjects.||||||<0.001
72416987|NCT01175850|144344895|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Chi-squared|||||||<0.001
72416988|NCT01175850|144344896|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Chi-squared|||||||<0.001
72607810|NCT00427908|144744135|NON_INFERIORITY|Criterion indicative of non-inferiority: lower limit of the standardized asymptotic 95% confidence interval (CI) for the group difference (Nimenrix minus Mencevax) in the percentage of subjects with bactericidal vaccine response is greater than or equal to -15% for rSBA-MenW-135.|Difference in percentage|4.41|||||TWO_SIDED|95.0|1.51|12.21||||||To evaluate the non-inferiority of Nimenrix™ conjugate vaccine compared to Mencevax™ plain polysaccharide vaccine in terms of the vaccine response (VRR) to MenW-135. Response to a vaccine antigen component was defined as: For initially seronegative subject, post-vaccination serum bactericidal assay using rabbit complement (rSBA) titer ≥ 1:32. For initially seropositive subject, at least 4-fold increase in rSBA-MenW-135 titer from pre to post vaccination.||12.21|1.51|
72416989|NCT01175850|144344897|SUPERIORITY_OR_OTHER|||||||0.926|TWO_SIDED||||||Chi-squared|||||||0.926
72416990|NCT01175850|144344898|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Chi-squared|||||||<0.001
72416991|NCT01175850|144344899|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Chi-squared|||||||<0.001
72416992|NCT01175850|144344900|SUPERIORITY_OR_OTHER|||||||0.859|TWO_SIDED||||||Chi-squared|||||||0.859
72416993|NCT01175850|144344901|SUPERIORITY_OR_OTHER||||||>|0.999|TWO_SIDED||||||Chi-squared|||||||>0.999
72416994|NCT01175850|144344902|SUPERIORITY_OR_OTHER|||||||0.096|TWO_SIDED||||||Chi-squared|||||||0.096
72416995|NCT01175850|144344903|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Chi-squared|||||||<0.001
72416996|NCT01175850|144344904|SUPERIORITY_OR_OTHER|||||||0.121|TWO_SIDED||||||Chi-squared|||||||0.121
72416997|NCT01175850|144344905|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED||||||Chi-squared|||||||0.001
72416998|NCT01175850|144344906|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Chi-squared|||||||<0.001
72416999|NCT01175850|144344907|SUPERIORITY_OR_OTHER|||||||0.095|TWO_SIDED||||||Chi-squared|||||||0.095
72417000|NCT01175850|144344908|SUPERIORITY_OR_OTHER|||||||0.59|TWO_SIDED||||||Chi-squared|||||||0.590
72417001|NCT01175850|144344909|SUPERIORITY_OR_OTHER|||||||0.302|TWO_SIDED||||||Chi-squared|||||||0.302
72417002|NCT01175850|144344910|SUPERIORITY_OR_OTHER|||||||0.111|TWO_SIDED||||||Chi-squared|||||||0.111
72417003|NCT01175850|144344911|SUPERIORITY_OR_OTHER|||||||0.103|TWO_SIDED||||||Chi-squared|||||||0.103
72417004|NCT01175850|144344912|SUPERIORITY_OR_OTHER|||||||0.049|TWO_SIDED||||||Chi-squared|||||||0.049
72417005|NCT01137474|144344913|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.05|STANDARD_ERROR_OF_MEAN|0.9251||0.001|TWO_SIDED|95.0|-4.87|-1.24||Endpoint tested following a sequential testing procedure at two-sided alpha=0.05 to control the family-wise Type I error rate related to primary and secondary efficacy endpoints. Test performed since previous tests were significant.|Longitudinal repeated measures analysis|Only Week 12 data are presented; data from all weeks in double-blind period were included in the longitudinal repeated measures model.||Change from baseline to week 12 calculated using a longitudinal repeated measures analysis using direct likelihood with fixed categorical effects of treatment, week, treatment-by-week interaction, and randomization strata and continuous fixed covariates of baseline value and baseline value by week interaction. Data after rescue were not included in the analysis. With 253 patients per group, there is \>80% power to detect a difference of 3.5 mm Hg at alpha=0.05, assuming a common SD of 14 mm Hg.||-1.24|-4.87|0.0010
72417006|NCT01137474|144344914|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.46|STANDARD_ERROR_OF_MEAN|0.0673|<|0.0001|TWO_SIDED|95.0|-0.59|-0.33||Endpoint tested following a sequential testing procedure at two-sided alpha=0.05 to control the family-wise Type I error rate related to primary and secondary efficacy endpoints. Test performed since previous tests were significant.|Longitudinal repeated measures analysis|Only Week 12 data are presented; data from all weeks in the double-blind treatment period were included in the longitudinal repeated measures model||Change from baseline to week 12 was calculated using a longitudinal repeated measures analysis using direct likelihood with fixed categorical effects of treatment, week, treatment-by-week interaction, and randomization strata and continuous fixed covariates of baseline value and baseline value by week interaction. With 253 subjects per group, there is \>98% power to detect a difference of 0.4% at a=0.05, assuming a common SD of 1.1%.||-0.33|-0.59|<0.0001
72325280|NCT01815424|144173735|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.27|||<|0.0001|TWO_SIDED|95.0|2.46|11.86||Cochran-Mantel-Haenszel statistics adjusted for pooled investigator sites was used for the analysis. Each hypothesis was tested at a significance level of 0.05 (2-sided).|Cochran-Mantel-Haenszel|||For primary endpoint, step-down procedure used to preserve Type I error, sequential order of testing: PGA response for tofacitinib 10 mg vs placebo at Week 16; PASI75 response for tofacitinib 10 mg vs placebo at Week 16; PGA response for tofacitinib 5 mg vs placebo at Week 16; PASI75 response for tofacitinib 5 mg vs placebo at Week 16. If comparison at preceding step was significant, only then subsequent comparison was tested at the below specified significance level.||11.86|2.46|<0.0001
72325281|NCT01815424|144173736|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|41.71|||<|0.0001|TWO_SIDED|95.0|14.84|151.11||Cochran-Mantel-Haenszel statistics adjusted for pooled investigator sites was used for the analysis. Each hypothesis was tested at a significance level of 0.05 (2-sided).|Cochran-Mantel-Haenszel|||For primary endpoint, step-down procedure used to preserve Type I error, sequential order of testing: PGA response for tofacitinib 10 mg vs placebo at Week 16; PASI75 response for tofacitinib 10 mg vs placebo at Week 16; PGA response for tofacitinib 5 mg vs placebo at Week 16; PASI75 response for tofacitinib 5 mg vs placebo at Week 16. If comparison at preceding step was significant, only then subsequent comparison was tested at the below specified significance level.||151.11|14.84|<0.0001
72325282|NCT01815424|144173736|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|9.97|||<|0.0001|TWO_SIDED|95.0|4.06|25.17||Cochran-Mantel-Haenszel statistics adjusted for pooled investigator sites was used for the analysis. Each hypothesis was tested at a significance level of 0.05 (2-sided).|Cochran-Mantel-Haenszel|||For primary endpoint, step-down procedure used to preserve Type I error, sequential order of testing: PGA response for tofacitinib 10 mg vs placebo at Week 16; PASI75 response for tofacitinib 10 mg vs placebo at Week 16; PGA response for tofacitinib 5 mg vs placebo at Week 16; PASI75 response for tofacitinib 5 mg vs placebo at Week 16. If comparison at preceding step was significant, only then subsequent comparison was tested at the below specified significance level.||25.17|4.06|<0.0001
72325283|NCT01815424|144173737|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-71.54|STANDARD_ERROR_OF_MEAN|8.461|<|0.0001|TWO_SIDED|95.0|-88.2|-54.87||Mixed model with fixed effects for treatment, visit, treatment-by-visit interaction, baseline value, and a random effect of subject; unstructured covariance matrix was used. Each hypothesis was tested at a significance of 0.025 (2-sided).|Mixed Models Analysis|||This is a key secondary endpoint; family-wise step-down procedure was used to control Type I error. Sequential order of testing: percent change in BSA at Week 16, PASI90 response at Week 16, change in DLQI total score at Week 16, PGA response at Week 4, PASI75 at Week 4, change in DLQI total score at Week 4, percent change in NAPSI score at Week 16. If comparison at preceding step was significant, only then subsequent comparison was tested at the below specified significance level.||-54.87|-88.20|<0.0001
72325284|NCT01815424|144173737|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-52.12|STANDARD_ERROR_OF_MEAN|8.416|<|0.0001|TWO_SIDED|95.0|-68.7|-35.55||Mixed model with fixed effects for treatment, visit, treatment-by-visit interaction, baseline value, and a random effect of subject; unstructured covariance matrix was used. Each hypothesis was tested at a significance level of 0.025 (2-sided).|Mixed Models Analysis|||This is a key secondary endpoint; family-wise step-down procedure was used to control Type I error. Sequential order of testing: percent change in BSA at Week 16, PASI90 response at Week 16, change in DLQI total score at Week 16, PGA response at Week 4, PASI75 at Week 4, change in DLQI total score at Week 4, percent change in NAPSI score at Week 16. If comparison at preceding step was significant, only then subsequent comparison was tested at the below specified significance level.||-35.55|-68.70|<0.0001
72325285|NCT01815424|144173738|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|70.31|||<|0.0001|TWO_SIDED|95.0|13.38|267.15||Cochran-Mantel-Haenszel statistics adjusted for pooled investigator sites was used for the analysis. Each hypothesis was tested at significance level of 0.025 (2-sided).|Cochran-Mantel-Haenszel|||This is a key secondary endpoint; family-wise step-down procedure was used to control Type I error. Sequential order of testing: percent change in BSA at Week 16, PASI90 response at Week 16, change in DLQI total score at Week 16, PGA response at Week 4, PASI75 at Week 4, change in DLQI total score at Week 4, percent change in NAPSI score at Week 16. If comparison at preceding step was significant, only then subsequent comparison was tested at the below specified significance level.||267.15|13.38|<0.0001
72325286|NCT01815424|144173738|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|16.44|||<|0.0001|TWO_SIDED|95.0|4.31|79.62||Cochran-Mantel-Haenszel statistics adjusted for pooled investigator sites was used for the analysis. Each hypothesis was tested at significance level of 0.025 (2-sided).|Cochran-Mantel-Haenszel|||This is a key secondary endpoint; family-wise step-down procedure was used to control Type I error. Sequential order of testing: percent change in BSA at Week 16, PASI90 response at Week 16, change in DLQI total score at Week 16, PGA response at Week 4, PASI75 at Week 4, change in DLQI total score at Week 4, percent change in NAPSI score at Week 16. If comparison at preceding step was significant, only then subsequent comparison was tested at the below specified significance level.||79.62|4.31|<0.0001
72325287|NCT01815424|144173739|SUPERIORITY_OR_OTHER||Least square mean difference|-7.52|STANDARD_ERROR_OF_MEAN|0.913|<|0.0001|TWO_SIDED|95.0|-9.32|5.72||Mixed model with fixed effects for treatment, visit, treatment-by-visit interaction, baseline value, and a random effect of subject; unstructured covariance matrix was used. Each hypothesis was tested at a significance of 0.025 (2-sided).|Mixed Models Analysis|||Week 16. This is a key secondary endpoint; family-wise step-down procedure was used to control Type I error. Sequential order of testing: percent change in BSA at Week 16, PASI90 response at Week 16, change in DLQI total score at Week 16, PGA response at Week 4, PASI75 at Week 4, change in DLQI total score at Week 4, percent change in NAPSI score at Week 16. If comparison at preceding step was significant, only then subsequent comparison was tested at the below specified significance level.||5.72|-9.32|<0.0001
72417007|NCT01137474|144344915|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.89|STANDARD_ERROR_OF_MEAN|1.0091||0.0043|TWO_SIDED|95.0|-4.88|-0.91||Endpoint tested following a sequential testing procedure at 2-sided alpha=0.05 to control the family-wise Type I error rate related to primary and secondary efficacy endpoints. Test performed since previous tests were significant.|ANCOVA|Only Week 12 data are presented; data from all weeks in double-blind period were included in the longitudinal repeated measures model.||Change from baseline to week 12 LOCF was calculated using an ANCOVA model with treatment group as an effect and baseline value and randomization strata as covariate. Data after rescue are excluded from blood pressure analyses.||-0.91|-4.88|0.0043
72325288|NCT01815424|144173739|SUPERIORITY_OR_OTHER||Least square mean difference|-5.45|STANDARD_ERROR_OF_MEAN|0.907|<|0.0001|TWO_SIDED|95.0|-7.24|-3.67||Mixed model with fixed effects for treatment, visit, treatment-by-visit interaction, baseline value, and a random effect of subject; unstructured covariance matrix was used. Each hypothesis was tested at a significance of 0.025 (2-sided).|Mixed Models Analysis|||Week 16. This is a key secondary endpoint; family-wise step-down procedure was used to control Type I error. Sequential order of testing: percent change in BSA at Week 16, PASI90 response at Week 16, change in DLQI total score at Week 16, PGA response at Week 4, PASI75 at Week 4, change in DLQI total score at Week 4, percent change in NAPSI score at Week 16. If comparison at preceding step was significant, only then subsequent comparison was tested at the below specified significance level.||-3.67|-7.24|<0.0001
72325289|NCT01815424|144173740|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|114.4|||<|0.0001|TWO_SIDED|95.0|8.95|2657.62||Cochran-Mantel-Haenszel statistics adjusted for pooled investigator sites was used for the analysis. Each hypothesis was tested at a significance level of 0.025 (2-sided).|Cochran-Mantel-Haenszel|||This is a key secondary endpoint; family-wise step-down procedure was used to control Type I error. Sequential order of testing: percent change in BSA at Week 16, PASI90 response at Week 16, change in DLQI total score at Week 16, PGA response at Week 4, PASI75 at Week 4, change in DLQI total score at Week 4, percent change in NAPSI score at Week 16. If comparison at preceding step was significant,only then subsequent comparison was tested at the below specified significance level.||2657.62|8.95|<0.0001
72325290|NCT01815424|144173740|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|35.37|||<|0.0001|TWO_SIDED|95.0|3.47|1084.02||Cochran-Mantel-Haenszel statistics adjusted for pooled investigator sites was used for the analysis. Each hypothesis was tested at a significance level of 0.025 (2-sided).|Cochran-Mantel-Haenszel|||This is a key secondary endpoint; family-wise step-down procedure was used to control Type I error. Sequential order of testing: percent change in BSA at Week 16, PASI90 response at Week 16, change in DLQI total score at Week 16, PGA response at Week 4, PASI75 at Week 4, change in DLQI total score at Week 4, percent change in NAPSI score at Week 16. If comparison at preceding step was significant, only then subsequent comparison was tested at the below specified significance level.||1084.02|3.47|<0.0001
72325291|NCT01815424|144173741|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Cochran-Mantel-Haenszel statistics adjusted for pooled investigator sites was used for the analysis. Each hypothesis was tested at a significance level of 0.025 (2-sided).|Cochran-Mantel-Haenszel|OR and 95% CI not available due to 0% frequency in placebo group.||This is a key secondary endpoint; family-wise step-down procedure was used to control Type I error. Sequential order of testing: percent change in BSA at Week 16, PASI90 response at Week 16, change in DLQI total score at Week 16, PGA response at Week 4, PASI75 at Week 4, change in DLQI total score at Week 4, percent change in NAPSI score at Week 16. If comparison at preceding step was significant, only then subsequent comparison was tested at the below specified significance level.||||<0.0001
72417008|NCT01137474|144344916|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0|STANDARD_ERROR_OF_MEAN|0.5811||0.0843|TWO_SIDED|95.0|-2.15|0.14||Endpoint tested following a sequential testing procedure at two-sided alpha=0.05 to control the family-wise Type I error rate related to primary and secondary efficacy endpoints. Test performed since previous tests were significant.|Longitudinal repeated measures analysis|Only Week 12 data are presented; data from all weeks in double-blind period were included in the longitudinal repeated measures model.||Change from baseline to week 12 was calculated using a longitudinal repeated measures analysis using direct likelihood with fixed categorical effects of treatment, week, treatment-by-week interaction, and randomization strata and continuous fixed covariates of baseline value and baseline value by week interaction. Data after rescue were not included in the analysis.||0.14|-2.15|0.0843
72417009|NCT01137474|144344917|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.62|STANDARD_ERROR_OF_MEAN|0.6866|||TWO_SIDED|95.0|-1.96|0.73||Endpoint tested following a sequential testing procedure at 2-sided alpha=0.05 to control the family-wise Type I error rate related to primary and secondary efficacy endpoints. Test not performed since previous tests were not significant.|ANCOVA|||Change from baseline to week 12 LOCF was calculated using an ANCOVA model with treatment group as an effect and baseline value and randomization strata as covariate. Data after rescue are excluded from blood pressure analyses.||0.73|-1.96|
72417010|NCT01137474|144344918|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.32|STANDARD_ERROR_OF_MEAN|0.0717|||TWO_SIDED|95.0|-0.46|-0.18||Endpoint tested following a sequential testing procedure at two-sided alpha=0.05 to control the family-wise Type I error rate related to primary and secondary efficacy endpoints. Test not performed since previous tests were not significant.|Longitudinal repeated measures analysis|Only Week 12 data are presented; data from all weeks in double-blind period were included in the longitudinal repeated measures model.||Change from baseline to week 12 was calculated using a longitudinal repeated measures analysis using direct likelihood with fixed categorical effects of treatment, week, treatment-by-week interaction, and randomization strata and continuous fixed covariates of baseline value and baseline value by week interaction.||-0.18|-0.46|
72417011|NCT04794803|144344919|SUPERIORITY||||||=|0.02164|||||||Log Rank|||||||= 0.02164
72325292|NCT01815424|144173741|SUPERIORITY_OR_OTHER|||||||0.0386||||||Cochran-Mantel-Haenszel statistics adjusted for pooled investigator sites was used for the analysis. Each hypothesis was tested at a significance level of 0.025 (2-sided).|Cochran-Mantel-Haenszel|OR and 95% CI not available due to 0% frequency in placebo group.||This is a key secondary endpoint; family-wise step-down procedure was used to control Type I error. Sequential order of testing: percent change in BSA at Week 16, PASI90 response at Week 16, change in DLQI total score at Week 16, PGA response at Week 4, PASI75 at Week 4, change in DLQI total score at Week 4, percent change in NAPSI score at Week 16. If comparison at preceding step was significant, only then subsequent comparison was tested at the below specified significance level.||||0.0386
72325293|NCT01815424|144173742|SUPERIORITY_OR_OTHER||Least square mean difference|-5.09|STANDARD_ERROR_OF_MEAN|0.709|<|0.0001|TWO_SIDED|95.0|-6.49|-3.7||Mixed model with fixed effects for treatment, visit, treatment-by-visit interaction, baseline value, and a random effect of subject; unstructured covariance matrix was used. Each hypothesis was tested at a significance of 0.025 (2-sided).|Mixed Models Analysis|||Week 4. This is a key secondary endpoint; family-wise step-down procedure was used to control Type I error. Sequential order of testing: percent change in BSA at Week 16, PASI90 response at Week 16, change in DLQI total score at Week 16, PGA response at Week 4, PASI75 at Week 4, change in DLQI total score at Week 4, percent change in NAPSI score at Week 16. If comparison at preceding step was significant, only then subsequent comparison was tested at the below specified significance level.||-3.70|-6.49|<0.0001
72325294|NCT01815424|144173742|SUPERIORITY_OR_OTHER||Least square mean difference|-4.2|STANDARD_ERROR_OF_MEAN|0.706|<|0.0001|TWO_SIDED|95.0|-5.59|-2.81||Mixed model with fixed effects for treatment, visit, treatment-by-visit interaction, baseline value, and a random effect of subject; unstructured covariance matrix was used. Each hypothesis was tested at a significance of 0.025 (2-sided).|Mixed Models Analysis|||Week 4. This is a key secondary endpoint; family-wise step-down procedure was used to control Type I error. Sequential order of testing: percent change in BSA at Week 16, PASI90 response at Week 16, change in DLQI total score at Week 16, PGA response at Week 4, PASI75 at Week 4, change in DLQI total score at Week 4, percent change in NAPSI score at Week 16. If comparison at preceding step was significant, only then subsequent comparison was tested at the below specified significance level.||-2.81|-5.59|<0.0001
72325295|NCT01815424|144173743|SUPERIORITY_OR_OTHER||Least square mean of difference|-41.23|STANDARD_ERROR_OF_MEAN|15.977||0.0113|TWO_SIDED|95.0|-72.91|-9.54||Mixed model with fixed effects for treatment, visit, treatment-by-visit interaction, baseline value, and a random effect of subject; unstructured covariance matrix was used. Each hypothesis was tested at a significance level of 0.025 (2-sided).|Mixed Models Analysis|||This is a key secondary endpoint; family-wise step-down procedure was used to control Type I error. Sequential order of testing: percent change in BSA at Week 16, PASI90 response at Week 16, change in DLQI total score at Week 16, PGA response at Week 4, PASI75 at Week 4, change in DLQI total score at Week 4, percent change in NAPSI score at Week 16. If comparison at preceding step was significant, only then subsequent comparison was tested at the below specified significance level.||-9.54|-72.91|0.0113
72325296|NCT01815424|144173743|SUPERIORITY_OR_OTHER||Least square mean of difference|-22.89|STANDARD_ERROR_OF_MEAN|16.01||0.1558|TWO_SIDED|95.0|-54.64|8.86||Mixed model with fixed effects for treatment, visit, treatment-by-visit interaction, baseline value, and a random effect of subject; unstructured covariance matrix was used. Each hypothesis was tested at a significance level of 0.025 (2-sided).|Mixed Models Analysis|||This is a key secondary endpoint; family-wise step-down procedure was used to control Type I error. Sequential order of testing: percent change in BSA at Week 16, PASI90 response at Week 16, change in DLQI total score at Week 16, PGA response at Week 4, PASI75 at Week 4, change in DLQI total score at Week 4, percent change in NAPSI score at Week 16. If comparison at preceding step was significant, only then subsequent comparison was tested at the below specified significance level.||8.86|-54.64|0.1558
72325297|NCT00328172|144173858|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.14||||0.3271||95.0|-0.41|0.14|||ANCOVA|ANCOVA model includes treatment as a fixed classification effect and baseline HbA1c as a linear covariate.||Linagliptin 0.5 mg versus placebo||0.14|-0.41|0.3271
72325298|NCT00328172|144173858|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.42||||0.0032||95.0|-0.69|-0.14|||ANCOVA|ANCOVA model includes treatment as a fixed classification effect and baseline HbA1c as a linear covariate.||Linagliptin 2.5 mg versus placebo||-0.14|-0.69|0.0032
72607811|NCT00427908|144744135|NON_INFERIORITY|Criterion indicative of non-inferiority: lower limit of the standardized asymptotic 95% confidence interval (CI) for the group difference (Nimenrux minus Mencevax) in the percentage of subjects with bactericidal vaccine response is greater than or equal to -15% for rSBA-MenY.|Difference in percentage|16.23|||||TWO_SIDED|95.0|8.99|26.78||||||To evaluate the non-inferiority of Nimenrix™ conjugate vaccine compared to Mencevax™ plain polysaccharide vaccine in terms of the vaccine response (VRR) to MenY. Response to a vaccine antigen component was defined as: For initially seronegative subject, post-vaccination serum bactericidal assay using rabbit complement (rSBA) titer ≥ 1:32. For initially seropositive subject, at least 4-fold increase in rSBA-MenY titer from pre to post vaccination.||26.78|8.99|
72325299|NCT00328172|144173858|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.46||||0.0012||95.0|-0.74|-0.18|||ANCOVA|ANCOVA model includes treatment as a fixed classification effect and baseline HbA1c as a linear covariate.||Linagliptin 5.0 mg versus placebo||-0.18|-0.74|0.0012
72325300|NCT00328172|144173858|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.85|||<|0.0001||95.0|-1.1|-0.59|||ANCOVA|ANCOVA model includes treatment as a fixed classification effect and baseline HbA1c as a linear covariate.||Metformin versus placebo||-0.59|-1.1|<0.0001
72325301|NCT00328172|144173859|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.45||||0.7027||95.0|-10.0|15.1|||ANCOVA|ANCOVA model includes treatment as a fixed classification effect and baseline FPG as a linear covariate.||Linagliptin 0.5 mg versus placebo||15.1|-10|0.7027
72325302|NCT00328172|144173859|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.4||||0.003||95.0|-32.0|-6.6|||ANCOVA|ANCOVA model includes treatment as a fixed classification effect and baseline FPG as a linear covariate.||Linagliptin 2.5 mg versus placebo||-6.6|-32|0.003
72325303|NCT00328172|144173859|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.3||||0.0418||95.0|-26.0|-0.5|||ANCOVA|ANCOVA model includes treatment as a fixed classification effect and baseline FPG as a linear covariate.||Linagliptin 5.0 mg versus placebo||-0.5|-26|0.0418
72325304|NCT00328172|144173859|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-34.3|||<|0.0001||95.0|-47.0|-22.0|||ANCOVA|ANCOVA model includes treatment as a fixed classification effect and baseline FPG as a linear covariate.||||-22|-47|< 0.0001
72325305|NCT00328172|144173860|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.735||||0.413||95.0|0.464|6.492|||Regression, Logistic|||Linagliptin 0.5 mg versus placebo||6.492|0.464|0.413
72325306|NCT00328172|144173860|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.157||||0.842||95.0|0.275|4.861|||Regression, Logistic|||Linagliptin 2.5 mg versus placebo||4.861|0.275|0.842
72325307|NCT00328172|144173860|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.844||||0.364||95.0|0.492|6.91|||Regression, Logistic|||Linagliptin 5.0 mg versus placebo||6.910|0.492|0.364
72325308|NCT00328172|144173860|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.224||||0.005||95.0|1.648|16.562|||Regression, Logistic|||Metformin versus placebo||16.562|1.648|0.005
72325309|NCT01990742|144173870|OTHER||||||>|0.05|||||||MOnte carlo simulation|||||||>0.05
72325310|NCT01990742|144173871|OTHER||||||>|0.05|||||||Monte carlo simulation|||||||>0.05
72325311|NCT01990742|144173872|OTHER||||||>|0.05|||||||Monte carlo simulation|||||||>0.05
72325312|NCT02261961|144173885|SUPERIORITY||Slope|-0.24275|||>|0.05|TWO_SIDED||||||ANCOVA|||||||>0.05
72325313|NCT02261961|144173886|SUPERIORITY||Slope|1.3707|||>|0.05|TWO_SIDED||||||ANCOVA|||||||>0.05
72325314|NCT02261961|144173889|SUPERIORITY||Slope|-0.35579|||>|0.05|TWO_SIDED||||||ANCOVA|||||||>0.05
72325315|NCT02261961|144173890|SUPERIORITY||Slope|0.004493|||>|0.05|TWO_SIDED||||||ANCOVA|||||||>0.05
72325316|NCT02261961|144173891|SUPERIORITY||Slope|0.870653|||>|0.05|TWO_SIDED||||||ANCOVA|||||||>0.05
72325317|NCT02261961|144173892|SUPERIORITY||Slope|-0.38664|||>|0.05|TWO_SIDED||||||ANCOVA|||||||>0.05
72325318|NCT02261961|144173893|SUPERIORITY||Slope|0.335124|||>|0.05|TWO_SIDED||||||ANCOVA|||Outcomes were compared as percent change from the baseline measure using multiple methods by a blinded statistician. Differences between groups were assessed using ANCOVA, Welch's t-test, and Wilcoxon. No significant differences were found between groups for any outcome regardless of method used.||||>0.05
72325319|NCT02261961|144173895|SUPERIORITY||Slope|0.03145|||>|0.05|TWO_SIDED||||||ANCOVA|||||||>0.05
72325320|NCT02261961|144173896|SUPERIORITY||Slope|-0.43902|||>|0.05|TWO_SIDED||||||ANCOVA|||||||>0.05
72325321|NCT02261961|144173906|SUPERIORITY||Slope|-0.07603|||>|0.05|TWO_SIDED||||||ANCOVA|||||||>0.05
72325322|NCT02261961|144173925|SUPERIORITY||Slope|-0.4745|||>|0.05|TWO_SIDED||||||ANCOVA|||||||>0.05
72325323|NCT01365793|144173963|SUPERIORITY|Each statistical test uses stratification to adjust for enrolling hospital, and the arm not being tested (e.g., the test for rapid vs slower rehydration is stratified by 0.45% and 0.9% Saline, and vice versa).||||||0.34||||||The a priori threshold for statistical significance for each of the 2 p-values is 0.025, for an overall significance of 0.50.|Cochran-Mantel-Haenszel|||The study uses a factorial experimental design, and tests two null hypotheses. The first of these hypotheses - the frequency of GCS score declines to \<14 is equal between the Rapid Rehydration and Slower Rehydration groups - is reported here. The analysis of the second hypothesis is reported below.||||0.34
72325324|NCT01365793|144173963|SUPERIORITY|Each statistical test uses stratification to adjust for enrolling hospital, and the arm not being tested (e.g., the test for rapid vs slower rehydration is stratified by 0.45% and 0.9% Saline, and vice versa).||||||0.43||||||The a priori threshold for statistical significance for each of the 2 p-values is 0.025, for an overall significance of 0.50.|Cochran-Mantel-Haenszel|||The study uses a factorial experimental design, and tests the two null hypotheses. The second of these hypotheses - the frequency of GCS score declines to \<14 is equal between the 0.45% Saline group and the 0.90% Saline group - is reported here. The analysis of the first hypothesis is reported above.||||0.43
72325325|NCT01469039|144173981|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||||||<0.001
72325326|NCT01469039|144173981|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||||||<0.001
72325327|NCT01469039|144173982|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||significant p-value, active vs placebo|Wilcoxon rank sum test based on LOCF|||||||<0.001
72325328|NCT01469039|144173982|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||significant p-value, active vs placebo|Wilcoxon rank sum test based on LOCF|||||||<0.001
72325329|NCT03623698|144173984|OTHER||Median Difference (Final Values)|-2.5|||<|0.001|TWO_SIDED|95.0|-4.0|-1.5|||Wilcoxon (Mann-Whitney)|||"Statistical analysis was performed using IBM SPSS Statistics software, version 25.~This analysis applies to the category of Total courses of antibiotics."||-1.500|-4.000|<0.001
72325330|NCT03623698|144173984|OTHER|Linear mixed-effects model|Restricted Maximum Likelihood (REML)|-2.88||||0.001|TWO_SIDED|95.0|-4.46|-1.29||95% confidence interval, significance level p-values \<0.05. Random effects pre-defined from theory and published data, and AIC was were used to define the best model. Outcome measures: Courses of antibiotics; Fixed effect: nebulised saline treatment.|Mixed Models Analysis|Random effects: age, gender, mechanical ventilation, tracheostomy, gastrostomy, non-ambulant.||"Statistical analysis was performed using IBM SPSS Statistics software, version 25.~This analysis applies to the category of Total courses of antibiotics."||-1.29|-4.46|0.001
72325331|NCT03623698|144173985|OTHER||Median Difference (Final Values)|-1.0||||0.001|TWO_SIDED|95.0|-1.5|-0.5|||Wilcoxon (Mann-Whitney)|||Statistical analysis was performed using IBM SPSS Statistics software, version 25.||-0.50|-1.50|0.001
72325332|NCT03623698|144173985|OTHER||Restricted Maximum Likelihood (REML)|-1.02|||<|0.001|TWO_SIDED|95.0|-1.53|-0.52||95% confidence interval, significance level p-values \<0.05. Random effects pre-defined from theory and published data, and AIC was were used to define the best model. Outcome measures: Courses of antibiotics; Fixed effect: nebulised saline treatment.|Mixed Models Analysis|Random effects: age, gender, prolonged mechanical ventilation (nasal or tracheostomy), and antibiotic prophylaxis||Statistical analysis was performed using IBM SPSS Statistics software, version 25.||-0.52|-1.53|<0.001
72325333|NCT03623698|144173988|OTHER||Median Difference (Final Values)|-4.5||||0.003|TWO_SIDED|95.0|-5.5|-3.0|||Wilcoxon (Mann-Whitney)|||||-3.00|-5.50|0.003
72325334|NCT03623698|144173989|OTHER||Mean Difference (Final Values)|-2.0|||<|0.001|TWO_SIDED|95.0|-2.5|-2.0|||Wilcoxon (Mann-Whitney)|||||-2.0|-2.5|<0.001
72325335|NCT03623698|144173992|OTHER||Mean Difference (Final Values)|0.17||||0.97|TWO_SIDED|95.0|-0.69|0.76|||Wilcoxon (Mann-Whitney)|||||0.76|-0.69|0.97
72607812|NCT00427908|144744138|NON_INFERIORITY|Criterion indicative of non-inferiority (serogroup C only): one month after vaccination, the lower limit of the 2-sided standardized asymptotic 95% CI for the group difference (Nimenrix Group minus Meningitec Group) in the percentage of subjects with rSBA titer ≥ 1:8 is greater than or equal to the predefined clinical limit of -15%.|Difference in vaccine response rate|1.47|||||TWO_SIDED|95.0|-0.27|7.89||||||To evaluate the non-inferiority of the vaccine response induced by Nimenrix™ conjugate vaccine when compared to the licensed Meningitec™ vaccine for MenC as measured by rSBA.||7.89|-0.27|
72607813|NCT02984982|144744229|SUPERIORITY||LS mean difference|-1.64|STANDARD_ERROR_OF_MEAN|1.36||0.2279|TWO_SIDED|95.0|-4.32|1.04||Threshold for significance at 0.05 level.|ANCOVA||Standard of Care vs Alirocumab|Analysis was performed using ANCOVA model which included fixed categorical effects of treatment arm and randomization strata, as well as the continuous fixed covariate of baseline normalized TAV.||1.04|-4.32|0.2279
72607814|NCT02616783|144744259|SUPERIORITY||Difference in Percentages|2.427|||<|0.001|TWO_SIDED|95.0|1.337|3.517|||ANOVA|P-value was calculated using the ANOVA model with baseline spine BMD score, sex, and treatment as fixed effects.|The 95% confidence intervals (CI) were calculated using the ANOVA model with baseline spine BMD score, sex, and treatment as fixed effects.|||3.517|1.337|<0.001
72607815|NCT02616783|144744260|SUPERIORITY||Difference in percentages|2.036|||<|0.001|TWO_SIDED|95.0|1.168|2.904|||ANOVA|P-value was calculated using the ANOVA model with baseline hip BMD score, sex, and treatment as fixed effects.|The 95% CIs were calculated using the ANOVA model with baseline hip BMD score, sex, and treatment as fixed effects.|||2.904|1.168|<0.001
72607816|NCT02616783|144744261|SUPERIORITY||Difference in percentages|1.749|||<|0.001|TWO_SIDED|95.0|0.726|2.771|||ANOVA|P-value was calculated using the ANOVA model with baseline spine BMD score, sex, and treatment as fixed effects.|The 95% CIs were calculated using the ANOVA model with baseline spine BMD score, sex, and treatment as fixed effects.|||2.771|0.726|<0.001
72607817|NCT02616783|144744262|SUPERIORITY||Difference in percentages|1.351|||<|0.001|TWO_SIDED|95.0|0.602|2.099|||ANOVA|P-value was calculated using the ANOVA model with baseline hip BMD score, sex, and treatment as fixed effects.|The 95% CIs were calculated using the ANOVA model with baseline hip BMD score, sex, and treatment as fixed effects.|||2.099|0.602|<0.001
72607818|NCT02616783|144744263|SUPERIORITY||Difference in percentages|-5.5||||0.18|TWO_SIDED|95.0|-11.8|1.6||P-values for the superiority test comparing the percentages of participants with HIV-1 RNA \< 50 copies/mL were from the Fisher exact test.|Fisher Exact||Differences in percentages and 95% CI were generated based on exact method.|||1.6|-11.8|0.18
72607819|NCT02616783|144744264|SUPERIORITY||Difference in percentages|-1.0||||1|TWO_SIDED|95.0|-8.5|9.3|||Fisher Exact|P-values for the superiority test comparing the percentages of participants with HIV-1 RNA \< 50 copies/mL were from the Fisher exact test.|Differences in percentages and 95% CI were generated based on exact method.|||9.3|-8.5|1.00
72607820|NCT02616783|144744265|SUPERIORITY||Difference in LSM|52.0||||0.053|TWO_SIDED|95.0|-1.0|106.0|||ANOVA|The p-value, difference in least square means (LSM), and its 95% CI were from ANOVA model with treatment as a fixed effect.||||106|-1|0.053
72607821|NCT02616783|144744266|SUPERIORITY||Difference in LSM|57.0||||0.051|TWO_SIDED|95.0|0.0|115.0|||ANOVA|The p-value, difference in LSM, and its 95% CI were from ANOVA model with treatment as a fixed effect.||||115|0|0.051
72607822|NCT04010461|144744303|SUPERIORITY||Mean Difference (Final Values)|0.159|STANDARD_ERROR_OF_MEAN|0.097|=|0.11|TWO_SIDED|95.0|-0.037|0.355|||t-test, 2 sided|df = 35 Note: 1 subject was excluded from analysis as extraction of FPN eigenvalues failed due to technical deficiencies with image data||Analysis used standard, open-source methods for pre-processing . First-level analysis used the general framework of the modified General Linear Model, implemented in SPM12 with temporal convolution. For the n-back activation task, the first-level design matrix included regressors for 2-back and 1-back conditions, as well as 24 movement parameters. Statistical testing was done to establish whether more or less BOLD (neural activity) change occurred between two conditions.||0.355|-0.037|=0.11
72325336|NCT03623698|144173993|OTHER||Mean Difference (Final Values)|-1.47||||0.09|TWO_SIDED|95.0|-3.26|0.34|||Wilcoxon (Mann-Whitney)|||||0.34|-3.26|0.09
72607823|NCT04010461|144744303|SUPERIORITY||Mean Difference (Final Values)|-0.009|STANDARD_ERROR_OF_MEAN|0.116||0.94|TWO_SIDED|95.0|-0.245|0.227|||t-test, 2 sided|df = 35 Note: 1 subject excluded from analysis as FPN extraction of eigenvalues failed due to technical issues with image data||Analysis used standard, open-source routes for slice timing correction, field map correction, realignment, smoothing (6 mm Gaussian kernel) and spatial normalization (MNI-152). First-level analysis used the general framework of the modified General Linear Model, implemented in SPM12 with temporal convolution. For the n-back activation task, the first-level design matrix included regressors for 2-back and 1-back conditions, as well as 24 movement parameters.||0.227|-0.245|0.94
72607824|NCT04010461|144744304|OTHER|Group-level analyses were performed using a General Linear Model (GLM). For each individual voxel, a separate GLM was estimated, with first-level connectivity measures at this voxel as dependent variables, and groups or other subject-level identifiers as independent variables. Voxel-level hypotheses were evaluated using multivariate parametric statistics with random effects across subjects and sample covariance estimation across multiple measurements.|random field theory|0.0||||1|TWO_SIDED|||||Inferences were performed at the level of individual clusters (groups of contiguous voxels). Cluster-level inferences were based on parametric statistics from Gaussian Random Field theory.|random field theory|Results were thresholded using a combination of a cluster-forming p \< 0.001 voxel-level threshold, and cluster-size threshold of 25 voxels|Number indicates the number of clusters above the threshold of significance for the contrast between two arms (passive vs active)|The contrast reflects the difference in connectivity between the conditions/sessions, at the level of each subject, then spatially averaged across all subjects. Functional connectivity strength for the dlPFC seed was represented by Fisher-transformed bivariate correlation coefficients from a weighted general linear model (weighted-GLM), defined separately for each pair of seed and target areas, modeling the association between their BOLD signal time series.||||1
72607825|NCT04010461|144744304|OTHER|The applied test with random field theory uses a metric of spatial dispersion, testing against the null hypothesis that spatial clusters of difference across the analyzed region are no different from chance clustering.|random field theory|0.0||||1|TWO_SIDED||||||random field theory||Number indicates the number of clusters above the threshold of significance for the contrast between two arms (passive vs control)|Results were thresholded using a combination of a cluster-forming p \< 0.001 voxel-level threshold, and a corrected false discovery rate (FDR) p \< 0.05 cluster-size threshold.||||1
72607826|NCT04010461|144744305|SUPERIORITY||F-ratio|0.1||||0.91|TWO_SIDED||||||ANOVA|||||||0.91
72607827|NCT04010461|144744306|SUPERIORITY|||||||0.55|||||||ANOVA|||||||0.55
72607828|NCT04010461|144744306|SUPERIORITY|||||||0.65|||||||ANOVA|||||||.65
72607829|NCT04010461|144744307|OTHER||cluster size|42.0||||0.54|TWO_SIDED|||||P-value above represents the lowest (most significant) value of the largest cluster, for the contrast of Passive \> Active, testing whether the cluster size is greater than chance.|random field theory||The estimated parameter is the size, in voxels, of the largest cluster. The applied test with random field theory tests whether the size of cluster difference across are no different from chance clustering.|Statistical thresholding using a random field model adjusted for multiple comparisons, with initial voxel magnitude/height threshold set at p \< 0.001 and peak and cluster-corrected significance levels obtained (false discovery rate \[FDR\]corrected), across the entire brain.||||0.54
72607830|NCT04010461|144744307|SUPERIORITY||cluster size|16.0||||0.93|TWO_SIDED|||||P-value above represents the lowest (most significant) value of the largest cluster, for the contrast of Passive \> Control, testing whether the size of this cluster is greater than one would expect by chance alone.|random field theory||The estimated parameter is the size, in voxels, of the largest cluster. The applied test with random field theory tests whether the size of cluster difference across are no different from chance clustering.|Statistical thresholding using a random field model adjusted for multiple comparisons, with initial voxel magnitude/height threshold set at p \< 0.001 and peak and cluster-corrected significance levels obtained (false discovery rate \[FDR\]corrected), across the entire brain..||||0.93
72607831|NCT04010461|144744308|SUPERIORITY||F-ratio|0.22||||0.8|TWO_SIDED||||||ANOVA|||Repeated measures ANOVA to test for differences in cerebral blood flow (perfusion) in the frontoparietal network||||0.8
72607832|NCT04010461|144744309|SUPERIORITY||F-ratio|3.96||||0.06|TWO_SIDED||||||ANOVA|||||||0.06
72607833|NCT04010461|144744309|SUPERIORITY||F-ratio|0.17||||0.68|TWO_SIDED||||||ANOVA|||||||0.68
72607834|NCT04010461|144744310|SUPERIORITY|Repeated measures ANOVA for 1- and 2-back conditions|F-ratio|0.72||||0.41|TWO_SIDED||||||ANOVA|||||||0.41
72607835|NCT04010461|144744310|SUPERIORITY|||||||0.5|||||||ANOVA|||||||0.50
72607836|NCT02027025|144744345|SUPERIORITY||LS mean difference|-0.48|STANDARD_ERROR_OF_MEAN|0.64||0.4532|TWO_SIDED|95.0|-1.73|0.78|||ANCOVA|||||0.78|-1.73|0.4532
72607837|NCT02027025|144744345|SUPERIORITY||LS mean difference|-0.47|STANDARD_ERROR_OF_MEAN|0.65||0.4704|TWO_SIDED|95.0|-1.76|0.82|||ANCOVA|||||0.82|-1.76|0.4704
72607838|NCT02027025|144744346|SUPERIORITY||LS mean difference|-0.19|STANDARD_ERROR_OF_MEAN|0.18||0.3013|TWO_SIDED|95.0|-0.56|0.17|||ANCOVA|||||0.17|-0.56|0.3013
72607839|NCT02027025|144744346|SUPERIORITY||LS mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.19||0.2994|TWO_SIDED|95.0|-0.58|0.18|||ANCOVA|||||0.18|-0.58|0.2994
72607840|NCT02027025|144744347|SUPERIORITY|||||||0.3815|||||||Chi-squared|||||||0.3815
72607841|NCT02027025|144744347|SUPERIORITY|||||||0.7491|||||||Chi-squared|||||||0.7491
72607842|NCT02027025|144744348|SUPERIORITY|||||||0.8991|||||||Chi-squared|||||||0.8991
72607843|NCT02027025|144744348|SUPERIORITY|||||||0.8829|||||||Chi-squared|||||||0.8829
72607844|NCT02360488|144744349|NON_INFERIORITY|The trial aimed to establish comparable efficacy based upon a non-inferiority margin of 30% of the change in Fugl-Meyer score in the In-Clinic group. Under these assumptions at alpha=0.05 and assuming SD=3.8 points, 124 subjects would need to be enrolled to provide 85% power; this sample was pursued independent of subject dropouts.|Mean Difference (Net)|0.06||||0.96|TWO_SIDED|95.0|-2.14|2.26|||Regression, Linear|The model was adjusted for study site, age, time post-stroke, stroke subtype, and baseline Fugl-Meyer score.||||2.26|-2.14|.96
72607845|NCT04350827|144744359|SUPERIORITY|||||||0.433|||||||ANOVA|||||||0.433
72607846|NCT03256578|144744374|SUPERIORITY|||||||0.896|||||||Wilcoxon (Mann-Whitney)|||||||0.896
72607847|NCT03256578|144744375|SUPERIORITY|||||||0.107|||||||Wilcoxon (Mann-Whitney)|||||||0.107
72607848|NCT03256578|144744376|SUPERIORITY|||||||0.847|||||||Wilcoxon (Mann-Whitney)|||||||0.847
72607849|NCT03256578|144744377|SUPERIORITY|||||||0.126|||||||Wilcoxon (Mann-Whitney)|||||||0.126
72607850|NCT03256578|144744378|SUPERIORITY|||||||0.346|||||||Wilcoxon (Mann-Whitney)|||||||0.346
72607851|NCT03256578|144744379|SUPERIORITY|||||||0.094|||||||Wilcoxon (Mann-Whitney)|||||||0.094
72607852|NCT03256578|144744380|SUPERIORITY|||||||0.656|||||||Wilcoxon (Mann-Whitney)|||||||0.656
72607853|NCT03256578|144744381|SUPERIORITY|||||||0.434|||||||Wilcoxon (Mann-Whitney)|||||||0.434
72607854|NCT03256578|144744382|SUPERIORITY|||||||0.903|||||||Wilcoxon (Mann-Whitney)|||||||0.903
72607855|NCT03256578|144744383|SUPERIORITY|||||||0.699|||||||Chi-squared|||||||0.699
72607856|NCT03256578|144744384|SUPERIORITY|||||||0.231|||||||Chi-squared|||||||0.231
72607857|NCT03256578|144744385|SUPERIORITY||Risk Ratio (RR)|0.593||||0.283|TWO_SIDED|95.0|0.225|1.561|||Chi-squared|||||1.561|0.225|0.283
72607858|NCT03256578|144744386|SUPERIORITY||Risk Ratio (RR)|1.864||||0.168|TWO_SIDED|95.0|0.756|4.599|||Chi-squared|||||4.599|0.756|0.168
72607859|NCT03256578|144744387|SUPERIORITY||Risk Ratio (RR)|0.67||||0.024|TWO_SIDED|95.0|0.474|0.947|||Chi-squared|||||0.947|0.474|0.024
72607860|NCT03256578|144744388|SUPERIORITY|||||||0.585|||||||Wilcoxon (Mann-Whitney)|||||||0.585
72325337|NCT03623698|144173994|OTHER||Mean Difference (Final Values)|-0.08||||0.65|TWO_SIDED|95.0|-0.38|0.38|||Wilcoxon (Mann-Whitney)|||||0.38|-0.38|0.65
72607861|NCT03256578|144744389|SUPERIORITY|||||||0.342|||||||Wilcoxon (Mann-Whitney)|||||||0.342
72607862|NCT03256578|144744390|SUPERIORITY|||||||0.431|||||||Wilcoxon (Mann-Whitney)|||||||0.431
72607863|NCT03256578|144744392|SUPERIORITY||Risk Ratio (RR)|1.059||||0.518|TWO_SIDED|95.0|0.854|1.313|||Chi-squared|||||1.313|0.854|0.518
72607864|NCT03256578|144744393|SUPERIORITY||Risk Ratio (RR)|0.951||||0.855|TWO_SIDED|95.0|0.555|1.629|||Chi-squared|||||1.629|0.555|0.855
72607865|NCT03256578|144744394|SUPERIORITY||Risk Ratio (RR)|0.994||||0.524|TWO_SIDED|95.0|0.834|1.186|||Chi-squared|||||1.186|0.834|0.524
72607866|NCT03256578|144744395|SUPERIORITY||Risk Ratio (RR)|0.649||||0.28|TWO_SIDED|95.0|0.294|1.434|||Chi-squared|||||1.434|0.294|0.280
72607867|NCT03256578|144744396|SUPERIORITY||Risk Ratio (RR)|1.393||||0.339|TWO_SIDED|95.0|0.703|2.76|||Chi-squared|||||2.760|0.703|0.339
72607868|NCT03256578|144744397|SUPERIORITY|||||||0.486|||||||Chi-squared|||||||0.486
72607869|NCT03256578|144744398|SUPERIORITY|||||||0.655|||||||Chi-squared|||||||0.655
72607870|NCT03256578|144744399|SUPERIORITY||Risk Ratio (RR)|1.0||||1|TWO_SIDED|95.0|0.99|1.02|||Chi-squared|||||1.02|0.99|1.00
72607871|NCT00922636|144744404|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.74||||0.008||95.0||||Statistical significance was assessed at an alpha level of 0.027 with a Dunnett adjustment for multiple comparisons.|Mixed Models Analysis|The Least Squares (LS) Mean Change is from a restricted maximum likelihood-based, mixed model repeated measure (MMRM) analysis.|The LS Mean difference was computed as treatment minus placebo.|||||0.008
72607872|NCT00922636|144744404|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.04||||0.006||95.0||||Statistical significance was assessed at an alpha level of 0.027 with a Dunnett adjustment for multiple comparisons.|Mixed Models Analysis|The Least Squares (LS) Mean Value is from a restricted maximum likelihood-based, mixed model repeated measure (MMRM) analysis.|The LS Mean difference was computed as treatment minus placebo.|||||0.006
72607873|NCT00922636|144744407|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.16||||0.938||95.0||||Statistical significance was assessed at an alpha level of 0.027 with a Dunnett adjustment for multiple comparisons.|Mixed Models Analysis|Least squares (LS) mean is from a restricted maximum likelihood-based, mixed model repeated measure (MMRM) analysis.||Gated secondary analysis for total score. If both LY2216684 groups (0.2 mg/kg/day and 0.3 mg/kg/day) were statistically significantly superior than placebo for the primary endpoint, then gated secondary analysis was assessed at an alpha level of 0.027. If only 0.2 mg/kg/day or 0.3 mg/kg/day LY2216684 was statistically significantly superior than placebo for the primary endpoint, then gated secondary analysis was assessed at an alpha level of 0.023 for the corresponding group.||||0.938
72607874|NCT00922636|144744407|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.44||||0.002||95.0||||Statistical significance was assessed at an alpha level of 0.027 with a Dunnett adjustment for multiple comparisons.|Mixed Models Analysis|Least squares (LS) mean is from a restricted maximum likelihood-based, mixed model repeated measure (MMRM) analysis.||Gated secondary analysis for total score. If both LY2216684 groups (0.2 mg/kg/day and 0.3 mg/kg/day) were statistically significantly superior than placebo for the primary endpoint, then gated secondary analysis was assessed at an alpha level of 0.027. If only 0.2 mg/kg/day or 0.3 mg/kg/day LY2216684 was statistically significantly superior than placebo for the primary endpoint, then gated secondary analysis was assessed at an alpha level of 0.023 for the corresponding group.||||0.002
72417012|NCT04794803|144344919|SUPERIORITY||||||=|0.20043|||||||Log Rank|||Sensitivity analysis of time to event for each single component of the primary endpoint: Supplemental oxygen requirement based on PaO2/FiO2||||= 0.20043
72607875|NCT03268343|144744479|SUPERIORITY||Geometric LS Mean Ratio (%)|74.71|||||TWO_SIDED|90.0|66.39|84.08|||||fed / fasted; results obtained using an ANOVA with fixed effects of treatment, period, sequence and participant (sequence).|||84.08|66.39|
72607876|NCT03268343|144744480|SUPERIORITY||Geometric LS Mean Ratio (%)|97.04|||||TWO_SIDED|90.0|94.2|99.98|||||fed / fasted; results obtained using an ANOVA with fixed effects of treatment, period, sequence and participant (sequence).|||99.98|94.20|
72607877|NCT03268343|144744481|SUPERIORITY||Median Difference (Final Values)|1.38|||<|0.0001|TWO_SIDED|95.0|0.5|2.25|||Wilcoxon Signed-Rank test||Hodges-Lehmann method|||2.25|0.50|< 0.0001
72607878|NCT03268343|144744482|SUPERIORITY||Geometric LS Mean Ratio (%)|96.52|||||TWO_SIDED|90.0|93.3|99.85|||||fed / fasted; results obtained using an ANOVA with fixed effects of treatment, period, sequence and participant (sequence).|||99.85|93.30|
72607879|NCT03268343|144744486|SUPERIORITY||Geometric LS Mean Ratio (%)|104.75|||||TWO_SIDED|95.0|98.97|110.87|||||fed / fasted; results obtained using an ANOVA with fixed effects of treatment, period, sequence and participant (sequence).|||110.87|98.97|
72417013|NCT04794803|144344919|SUPERIORITY||||||=|0.30215|||||||Log Rank|||Sensitivity analysis of time to event for each single component of the primary endpoint: time to first invasive mechanical ventilation||||= 0.30215
72417014|NCT04794803|144344919|SUPERIORITY|||||||0.5637|||||||Log Rank|||Sensitivity analysis of time to event for each single component of the primary endpoint: time to first admission to ICU||||0.56370
72417015|NCT04794803|144344919|SUPERIORITY||||||=|0.00132|||||||Log Rank|||Sensitivity analysis of time to event for each single component of the primary endpoint: time to first use of a rescue medication for any reason||||= 0.00132
72417016|NCT04794803|144344920|SUPERIORITY|||||||0.731|||||||Fisher Exact|||comparison at week 1||||0.731
72607880|NCT01307787|144744501|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002|||||||Wilcoxon (Mann-Whitney)|||Mann-Whitney U tests were used to assess between group changes on delta scores at times T0( at the start of the study in week 1) and T1( post-intervention in week 9). Significance level for all statistical tests was set at p\< 0.05.||||0.002
72607881|NCT01307787|144744502|SUPERIORITY_OR_OTHER_LEGACY|||||||0.47|||||||Wilcoxon (Mann-Whitney)|||Mann-Whitney U tests were used to assess between group changes on delta scores at times T0( at the start of the study in week 1) and T1( post-intervention in week 9). Significance level for all statistical tests was set at p\< 0.05.||||0.47
72607882|NCT01307787|144744503|SUPERIORITY_OR_OTHER_LEGACY|||||||0.24|||||||Wilcoxon (Mann-Whitney)|||Mann-Whitney U tests were used to assess between group changes on delta scores at times T0( at the start of the study in week 1) and T1( post-intervention in week 9). Significance level for all statistical tests was set at p\< 0.05.||||0.24
72607883|NCT01307787|144744504|SUPERIORITY_OR_OTHER_LEGACY|||||||0.16|||||||Wilcoxon (Mann-Whitney)|||Mann-Whitney U tests were used to assess between group changes on delta scores at times T0( at the start of the study in week 1) and T1( post-intervention in week 9). Significance level for all statistical tests was set at p\< 0.05.||||0.16
72607884|NCT01307787|144744505|SUPERIORITY_OR_OTHER_LEGACY|||||||0.21|||||||Wilcoxon (Mann-Whitney)|||Mann-Whitney U tests were used to assess between group changes on delta scores at times T0( at the start of the study in week 1) and T1( post-intervention in week 9). Significance level for all statistical tests was set at p\< 0.05.||||0.21
72607885|NCT01307787|144744506|SUPERIORITY_OR_OTHER_LEGACY|||||||0.07|||||||Wilcoxon (Mann-Whitney)|||Mann-Whitney U tests were used to assess between group changes on delta scores at times T0( at the start of the study in week 1) and T1( post-intervention in week 9). Significance level for all statistical tests was set at p\< 0.05.||||0.07
72607886|NCT01307787|144744507|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4|||||||Wilcoxon (Mann-Whitney)|||Mann-Whitney U tests were used to assess between group changes on delta scores at times T0( at the start of the study in week 1) and T1( post-intervention in week 9). Significance level for all statistical tests was set at p\< 0.05.||||0.4
72607887|NCT01307787|144744508|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6|||||||Wilcoxon (Mann-Whitney)|||Mann-Whitney U tests were used to assess between group changes on delta scores at times T0( at the start of the study in week 1) and T1( post-intervention in week 9). Significance level for all statistical tests was set at p\< 0.05.||||0.6
72417017|NCT04794803|144344920|SUPERIORITY|||||||1|||||||Fisher Exact|||at EOT||||1.000
72417018|NCT04794803|144344920|SUPERIORITY|||||||1|||||||Fisher Exact|||at EOS||||1.000
72607888|NCT01507181|144744528|SUPERIORITY_OR_OTHER|||||||0.32|TWO_SIDED||||||t-test, 2 sided|||||||0.32
72417019|NCT04794803|144344921|SUPERIORITY|||||||0.353|||||||Fisher Exact|||at baseline||||0.353
72417020|NCT04794803|144344921|SUPERIORITY|||||||0.401|||||||Fisher Exact|||At Day 1||||0.401
72607889|NCT01507181|144744529|SUPERIORITY_OR_OTHER|||||||0.047|TWO_SIDED||||||t-test, 2 sided|||||||0.047
72607890|NCT01507181|144744530|SUPERIORITY_OR_OTHER|||||||0.17||||||Statistics are calculated by comparing 24-h scores using separate ANCOVAs and controlling for baseline severity.|ANCOVA|||||||0.17
72325338|NCT00811954|144173999|NON_INFERIORITY_OR_EQUIVALENCE|Confidence interval estimation was stratified by HIV-1 RNA level at screening using Greenwood's variance with the inverse of this variance used for the stratum weights. The pre-specified confidence bounds for equivalence were +/-10 percentage points.|Cumulative probability difference|3.4|||||TWO_SIDED|97.5|-0.7|7.4||||||Treatment comparison was made using the difference (arm A - arm B) in the stratified Kaplan-Meier estimate for the week 96 cumulative probability of virologic failure with 97.5% confidence interval.||7.4|-0.7|
72325339|NCT00811954|144173999|NON_INFERIORITY_OR_EQUIVALENCE|Confidence interval estimation was stratified by HIV-1 RNA level at screening using Greenwood's variance with the inverse of this variance used for the stratum weights. The pre-specified confidence bounds for equivalence were +/-10 percentage points.|Cumulative probability difference|5.6|||||TWO_SIDED|97.5|1.3|9.9||||||Treatment comparison was made using the difference (arm C - arm B) in the stratified Kaplan-Meier estimate for the week 96 cumulative probability of virologic failure with 97.5% confidence interval.||9.9|1.3|
72325340|NCT00811954|144173999|NON_INFERIORITY_OR_EQUIVALENCE|Confidence interval estimation was stratified by HIV-1 RNA level at screening using Greenwood's variance with the inverse of this variance used for the stratum weights. The pre-specified confidence bounds for equivalence were +/-10 percentage points.|Cumulative probability difference|-2.2|||||TWO_SIDED|97.5|-6.7|2.3||||||Treatment comparison was made using the difference (arm A - arm C) in the stratified Kaplan-Meier estimate for the week 96 cumulative probability of virologic failure with 97.5% confidence interval.||2.3|-6.7|
72325341|NCT00811954|144174000|NON_INFERIORITY_OR_EQUIVALENCE|Although the study was not specifically powered to be able to detect equivalence, equivalence was declared if the 97.5% confidence interval difference in the cumulative probability of the tolerability endpoint by 96 weeks was entirely contained within +/-10 percentage points.|Cumulative incidence difference|12.8|||||TWO_SIDED|97.5|9.4|16.1||||||Treatment comparison was made using the methods of Gray. Inference regarding comparisons of the treatment groups (arm A and arm B) with respect to equivalence was made based on the two-sided 97.5% confidence intervals of differences (arm A - arm B) in 96 week probability of tolerability failure with 97.5% confidence interval.||16.1|9.4|
72325342|NCT00811954|144174000|NON_INFERIORITY_OR_EQUIVALENCE|Although the study was not specifically powered to be able to detect equivalence, equivalence was declared if the 97.5% confidence interval difference in the cumulative probability of the tolerability endpoint by 96 weeks was entirely contained within +/-10 percentage points.|Cumulative incidence difference|3.6|||||TWO_SIDED|97.5|1.4|5.8||||||Treatment comparison was made using the methods of Gray. Inference regarding comparisons of the treatment groups (arm C and arm B) with respect to equivalence was made based on the two-sided 97.5% confidence intervals of differences (arm C - arm B) in 96 week probability of tolerability failure with 97.5% confidence interval.||5.8|1.4|
72325343|NCT00811954|144174000|NON_INFERIORITY_OR_EQUIVALENCE|Although the study was not specifically powered to be able to detect equivalence, equivalence was declared if the 97.5% confidence interval difference in the cumulative probability of the tolerability endpoint by 96 weeks was entirely contained within +/-10 percentage points.|Cumulative incidence difference|9.2|||||TWO_SIDED|97.5|5.5|12.9||||||Treatment comparison was made using the methods of Gray. Inference regarding comparisons of the treatment groups (arm A and arm C) with respect to equivalence was made based on the two-sided 97.5% confidence intervals of differences (arm A - arm C) in 96 week probability of tolerability failure with 97.5% confidence interval.||12.9|5.5|
72417021|NCT04794803|144344921|SUPERIORITY|||||||0.066|||||||Fisher Exact|||At Day 2||||0.066
72325344|NCT05525910|144174055|OTHER|Analysis done using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Ratio and 90% CI are expressed as percentages.|Ratio (%) of Adjusted Geometric Means|105.03|||||TWO_SIDED|90.0|94.54|116.68||||||Reference: Nirmatrelvir/ritonavir 300(2\*150)/100 mg Test: Nirmatrelvir/ritonavir 2\*(150/50 mg) Low Disintegrant||116.68|94.54|
72325345|NCT05525910|144174055|OTHER|Analysis done using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Ratio and 90% CI are expressed as percentages.|Ratio (%) of Adjusted Geometric Means|109.15|||||TWO_SIDED|90.0|98.08|121.47||||||Reference: Nirmatrelvir/ritonavir 300(2\*150)/100 mg Test: Nirmatrelvir/ritonavir 2\*(150/50 mg) High Disintegrant||121.47|98.08|
72417022|NCT04794803|144344921|SUPERIORITY|||||||0.102|||||||Fisher Exact|||At week 1||||0.102
72417023|NCT04794803|144344921|SUPERIORITY|||||||0.314|||||||Fisher Exact|||at EOT||||0.314
72417024|NCT04794803|144344921|SUPERIORITY|||||||1|||||||Fisher Exact|||at EOS||||1.000
72417025|NCT04794803|144344922|SUPERIORITY||||||>|0.999||||||p-values are referred to a two-sided Wilcoxon test for differences in the change of VAS scale.|Wilcoxon (Mann-Whitney)|||Day 1 vs baseline||||>0.999
72417026|NCT04794803|144344922|SUPERIORITY||||||>|0.999||||||p-values are referred to a two-sided Wilcoxon test for differences in the change of VAS scale.|Wilcoxon (Mann-Whitney)|||Day 2 vs baseline||||>0.999
72417027|NCT04794803|144344922|SUPERIORITY|||||||0.05||||||p-values are referred to a two-sided Wilcoxon test for differences in the change of VAS scale.|Wilcoxon (Mann-Whitney)|||week 1 vs baseline||||0.050
72607891|NCT02351934|144744552|SUPERIORITY|||||||0.564|||||||Wilcoxon (Mann-Whitney)|||Significance level of 0.05 was used.||||0.564
72607892|NCT02351934|144744553|SUPERIORITY|||||||0.675|||||||Wilcoxon (Mann-Whitney)|||Significance level of 0.05 was used.||||0.675
72607893|NCT02351934|144744554|SUPERIORITY|||||||0.125|||||||Wilcoxon (Mann-Whitney)|||Significance level of 0.05 was used.||||0.125
72607894|NCT02351934|144744556|SUPERIORITY|||||||0.595|||||||Wilcoxon (Mann-Whitney)|||Significance level of 0.05 was used.||||0.595
72607895|NCT02351934|144744557|SUPERIORITY|||||||0.985|||||||Wilcoxon (Mann-Whitney)|||Significance level of 0.05 was used.||||0.985
72607896|NCT01115452|144744567|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.32||||0.9347|TWO_SIDED|95.0|-8.14|7.5||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.|Difference was calculated as adjusted mean change from baseline in 5% potassium nitrate solution minus 2.5% potassium nitrate solution. Negative difference favored 5% potassium nitrate solution.|Null hypothesis was no difference between treatments.||7.50|-8.14|0.9347
72607897|NCT01115452|144744568|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.02||||0.9963|TWO_SIDED|95.0|-8.2|8.24||Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.|ANCOVA|No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|Difference was calculated as adjusted mean change from baseline in 5% potassium nitrate solution minus 2.5% potassium nitrate solution. Negative difference favored 5% potassium nitrate solution.|Null hypothesis is no difference between treatments.||8.24|-8.20|0.9963
72607898|NCT01115452|144744568|SUPERIORITY_OR_OTHER||Adjusted mean difference|3.9||||0.3582|TWO_SIDED|95.0|-4.45|12.25||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.|Difference was calculated as adjusted mean change from baseline in 5% potassium nitrate solution minus water. Negative difference favored 5% potassium nitrate solution.|Null hypothesis is no difference between treatments.||12.25|-4.45|0.3582
72607899|NCT01115452|144744568|SUPERIORITY_OR_OTHER||Adjusted mean difference|3.88||||0.36|TWO_SIDED|95.0|-4.46|12.22||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.|Difference was calculated as adjusted mean change from baseline in 2.5% potassium nitrate solution minus water. Negative difference favored 2.5% potassium nitrate solution.|Null hypothesis is no difference between treatments.||12.22|-4.46|0.3600
72607900|NCT01115452|144744569|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.91||||0.8265|TWO_SIDED|95.0|-9.13|7.3||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.|Difference was calculated as adjusted mean change from baseline in 5% potassium nitrate solution minus 2.5% potassium nitrate solution. Negative difference favored 5% potassium nitrate solution.|Null hypothesis is no difference between treatments.||7.30|-9.13|0.8265
72607901|NCT01115452|144744569|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.9||||0.8314|TWO_SIDED|95.0|-9.25|7.45||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.|Difference was calculated as adjusted mean change from baseline in 5% potassium nitrate solution minus water. Negative difference favored 5% potassium nitrate solution.|Null hypothesis is no difference between treatments.||7.45|-9.25|0.8314
72607902|NCT01115452|144744569|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.01||||0.9978|TWO_SIDED|95.0|-8.33|8.35||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.|Difference was calculated as adjusted mean change from baseline in 2.5% potassium nitrate solution minus water. Negative difference favored 2.5% potassium nitrate solution.|Null hypothesis is no difference between treatments.||8.35|-8.33|0.9978
72607903|NCT01115452|144744570|SUPERIORITY_OR_OTHER||Adjusted mean difference|4.22||||0.3122|TWO_SIDED|95.0|-4.0|12.44|||ANCOVA|Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.|Difference was calculated as adjusted mean change from baseline in 5% potassium nitrate solution minus 2.5% potassium nitrate solution. Negative difference favored 5% potassium nitrate solution.|Null hypothesis is no difference between treatments.||12.44|-4.00|0.3122
72607904|NCT01115452|144744570|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.27||||0.7646|TWO_SIDED|95.0|-9.62|7.08||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.|Difference was calculated as adjusted mean change from baseline in 5% potassium nitrate solution minus 2.5% potassium nitrate solution. Negative difference favored 5% potassium nitrate solution.|Null hypothesis is no difference between treatments.||7.08|-9.62|0.7646
72607905|NCT01115452|144744570|SUPERIORITY_OR_OTHER||Adjusted mean difference|-5.49||||0.1957||95.0|-13.83|2.85||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.|Difference was calculated as adjusted mean change from baseline in 2.5% potassium nitrate solution minus water. Negative difference favored 2.5% potassium nitrate solution.|Null hypothesis is no difference between treatments.||2.85|-13.83|0.1957
72607906|NCT01115452|144744571|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.35||||0.7472|TWO_SIDED|95.0|-9.62|6.92||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.|Difference was calculated as adjusted mean change from baseline in 5% potassium nitrate solution minus 2.5% potassium nitrate solution. Negative difference favored 5% potassium nitrate solution.|Null hypothesis is no difference between treatments.||6.92|-9.62|0.7472
72607907|NCT01115452|144744571|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.66||||0.8767||95.0|-7.75|9.08||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.|Difference was calculated as adjusted mean change from baseline in 5% potassium nitrate solution minus water. Negative difference favored 5% potassium nitrate solution|Null hypothesis is no difference between treatments.||9.08|-7.75|0.8767
72325346|NCT05525910|144174055|OTHER|Analysis done using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Ratio and 90% CI are expressed as percentages.|Ratio of Adjusted Geometric Means|100.72|||||TWO_SIDED|90.0|90.79|111.74||||||Reference: Nirmatrelvir/ritonavir 300(2\*150)/100 mg Test: Nirmatrelvir/ritonavir 2\*(150/50 mg) HDL||111.74|90.79|
72325347|NCT05525910|144174055|OTHER|Analysis done using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Ratio and 90% CI are expressed as percentages.|Ratio of Adjusted Geometric Means|110.45|||||TWO_SIDED|90.0|99.58|122.52||||||Reference: Nirmatrelvir/ritonavir 300(2\*150)/100 mg Test: Nirmatrelvir/ritonavir 3\*(100/33.3 mg)||122.52|99.58|
72325348|NCT05525910|144174056|OTHER|Analysis done using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Ratio and 90% CI are expressed as percentages.|Ratio (%) of Adjusted Geometric Means|104.86|||||TWO_SIDED|90.0|93.78|117.24||||||Reference: Nirmatrelvir/ritonavir 300(2\*150)/100 mg Test: Nirmatrelvir/ritonavir 2\*(150/50 mg) Low Disintegrant||117.24|93.78|
72325349|NCT05525910|144174056|OTHER|Analysis done using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Ratio and 90% CI are expressed as percentages.|Ratio (%) of Adjusted Geometric Means|109.7|||||TWO_SIDED|90.0|97.93|122.89||||||Reference: Nirmatrelvir/ritonavir 300(2\*150)/100 mg Test: Nirmatrelvir/ritonavir 2\*(150/50 mg) High Disintegrant||122.89|97.93|
72325350|NCT05525910|144174056|OTHER|Analysis done using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Ratio and 90% CI are expressed as percentages.|Ratio of Adjusted Geometric Means|100.14|||||TWO_SIDED|90.0|89.69|111.8||||||Reference: Nirmatrelvir/ritonavir 300(2\*150)/100 mg Test: Nirmatrelvir/ritonavir 2\*(150/50 mg) HDL||111.80|89.69|
72325351|NCT05525910|144174056|OTHER|Analysis done using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Ratio and 90% CI are expressed as percentages.|Ratio of Adjusted Geometric Means|109.8|||||TWO_SIDED|90.0|98.36|122.57||||||Reference: Nirmatrelvir/ritonavir 300(2\*150)/100 mg Test: Nirmatrelvir/ritonavir 3\*(100/33.3 mg)||122.57|98.36|
72325352|NCT05525910|144174057|OTHER|Analysis done using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Ratio and 90% CI are expressed as percentages.|Ratio (%) of Adjusted Geometric Means|109.85|||||TWO_SIDED|90.0|94.97|127.06||||||Reference: Nirmatrelvir/ritonavir 300(2\*150)/100 mg Test: Nirmatrelvir/ritonavir 2\*(150/50 mg) Low Disintegrant||127.06|94.97|
72325353|NCT05525910|144174057|OTHER|Analysis done using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Ratio and 90% CI are expressed as percentages.|Ratio (%) of Adjusted Geometric Means|114.69|||||TWO_SIDED|90.0|98.92|132.98||||||Reference: Nirmatrelvir/ritonavir 300(2\*150)/100 mg Test: Nirmatrelvir/ritonavir 2\*(150/50 mg) High Disintegrant||132.98|98.92|
72325354|NCT05525910|144174057|OTHER|Analysis done using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Ratio and 90% CI are expressed as percentages.|Ratio of Adjusted Geometric Means|109.26|||||TWO_SIDED|90.0|94.64|126.14||||||Reference: Nirmatrelvir/ritonavir 300(2\*150)/100 mg Test: Nirmatrelvir/ritonavir 2\*(150/50 mg) HDL||126.14|94.64|
72325355|NCT05525910|144174057|OTHER|Analysis done using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Ratio and 90% CI are expressed as percentages.|Ratio of Adjusted Geometric Means|115.98|||||TWO_SIDED|90.0|100.48|133.87||||||Reference: Nirmatrelvir/ritonavir 300(2\*150)/100 mg Test: Nirmatrelvir/ritonavir 3\*(100/33.3 mg)||133.87|100.48|
72325356|NCT05525910|144174058|OTHER|Analysis done using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Ratio and 90% CI are expressed as percentages.|Ratio (%) of Adjusted Geometric Means|88.85|||||TWO_SIDED|90.0|76.24|103.53||||||Reference: Nirmatrelvir/ritonavir 300(2\*150)/100 mg Test: Nirmatrelvir/ritonavir 2\*(150/50 mg) Low Disintegrant||103.53|76.24|
72325357|NCT05525910|144174058|OTHER|Analysis done using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Ratio and 90% CI are expressed as percentages.|Ratio (%) of Adjusted Geometric Means|95.11|||||TWO_SIDED|90.0|81.41|111.11||||||Reference: Nirmatrelvir/ritonavir 300(2\*150)/100 mg Test: Nirmatrelvir/ritonavir 2\*(150/50 mg) High Disintegrant||111.11|81.41|
72325358|NCT05525910|144174058|OTHER|Analysis done using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Ratio and 90% CI are expressed as percentages.|Ratio of Adjusted Geometric Means|85.74|||||TWO_SIDED|90.0|73.73|99.7||||||Reference: Nirmatrelvir/ritonavir 300(2\*150)/100 mg Test: Nirmatrelvir/ritonavir 2\*(150/50 mg) HDL||99.70|73.73|
72325359|NCT05525910|144174058|OTHER|Analysis done using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Ratio and 90% CI are expressed as percentages.|Ratio of Adjusted Geometric Means|93.12|||||TWO_SIDED|90.0|80.09|108.26||||||Reference: Nirmatrelvir/ritonavir 300(2\*150)/100 mg Test: Nirmatrelvir/ritonavir 3\*(100/33.3 mg)||108.26|80.09|
72325360|NCT05525910|144174059|OTHER|Analysis done using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Ratio and 90% CI are expressed as percentages.|Ratio (%) of Adjusted Geometric Means|88.43|||||TWO_SIDED|90.0|74.64|104.78||||||Reference: Nirmatrelvir/ritonavir 300(2\*150)/100 mg Test: Nirmatrelvir/ritonavir 2\*(150/50 mg) Low Disintegrant||104.78|74.64|
72325361|NCT05525910|144174059|OTHER|Analysis done using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Ratio and 90% CI are expressed as percentages.|Ratio (%) of Adjusted Geometric Means|96.0|||||TWO_SIDED|90.0|80.8|114.06||||||Reference: Nirmatrelvir/ritonavir 300(2\*150)/100 mg Test: Nirmatrelvir/ritonavir 2\*(150/50 mg) High Disintegrant||114.06|80.80|
72417028|NCT04794803|144344922|SUPERIORITY|||||||0.0227||||||p-values are referred to a two-sided Wilcoxon test for differences in the change of VAS scale.|Wilcoxon (Mann-Whitney)|||EOT vs baseline||||0.0227
72607908|NCT01115452|144744571|SUPERIORITY_OR_OTHER||Adjusted mean difference|2.01||||0.6367||95.0|-6.39|10.42||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.|Difference was calculated as adjusted mean change from baseline in 2.5% potassium nitrate solution minus water. Negative difference favored 2.5% potassium nitrate solution.|Null hypothesis is no difference between treatments.||10.42|-6.39|0.6367
72607909|NCT01115452|144744572|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.95||||0.6417|TWO_SIDED|95.0|-10.22|6.32||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.|Difference was calculated as adjusted mean change from baseline in 5% potassium nitrate solution minus 2.5% potassium nitrate solution. Negative difference favored 5% potassium nitrate solution.|Null hypothesis is no difference between treatments.||6.32|-10.22|0.6417
72607910|NCT01115452|144744572|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.43||||0.92|TWO_SIDED|95.0|-7.99|8.85||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.|Difference was calculated as adjusted mean change from baseline in 5% potassium nitrate solution minus water. Negative difference favored 5% potassium nitrate solution.|Null hypothesis is no difference between treatments.||8.85|-7.99|0.9200
72607911|NCT01115452|144744572|SUPERIORITY_OR_OTHER||Adjusted mean difference|2.38||||0.5766||95.0|-6.02|10.78||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.|Difference was calculated as adjusted mean change from baseline in 2.5% potassium nitrate solution minus water. Negative difference favored 2.5% potassium nitrate solution.|Null hypothesis is no difference between treatments.||10.78|-6.02|0.5766
72607912|NCT01115452|144744573|SUPERIORITY_OR_OTHER||Adjusted mean difference|-3.58||||0.393|TWO_SIDED|95.0|-11.65|4.68||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.|Difference was calculated as adjusted mean change from baseline in 5% potassium nitrate solution minus 2.5% potassium nitrate solution. Negative difference favored 5% potassium nitrate solution.|Null hypothesis is no difference between treatments.||4.68|-11.65|0.3930
72607913|NCT01115452|144744573|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.7||||0.6896|TWO_SIDED|95.0|-10.12|6.71||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.|Difference was calculated as adjusted mean change from baseline in 5% potassium nitrate solution minus water. Negative difference favored 5% potassium nitrate solution.|Null hypothesis is no difference between treatments.||6.71|-10.12|0.6896
72607914|NCT01115452|144744573|SUPERIORITY_OR_OTHER||Adjustes mean difference|1.88||||0.6591|TWO_SIDED|95.0|-6.52|10.28||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.|Difference was calculated as adjusted mean change from baseline in 2.5% potassium nitrate solution minus water. Negative difference favored 2.5% potassium nitrate solution.|Null hypothesis is no difference between treatments.||10.28|-6.52|0.6591
72607915|NCT01115452|144744574|SUPERIORITY_OR_OTHER||Adjusted mean difference|-2.08||||0.6301||95.0|-10.6|6.45||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.|Difference was calculated as adjusted mean change from baseline in 5% potassium nitrate solution minus 2.5% potassium nitrate solution. Negative difference favored 5% potassium nitrate solution.|Null hypothesis is no difference between treatments.||6.45|-10.60|0.6301
72417029|NCT04794803|144344923|SUPERIORITY|||||||0.122|||||||Wilcoxon (Mann-Whitney)|||At Day 1||||0.122
72417030|NCT04794803|144344923|SUPERIORITY|||||||0.985|||||||Wilcoxon (Mann-Whitney)|||At Day 2||||0.985
72607916|NCT01115452|144744574|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.76||||0.6888|TWO_SIDED|95.0|-10.46|6.93||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.|Difference was calculated as adjusted mean change from baseline in 5% potassium nitrate solution minus water. Negative difference favored 5% potassium nitrate solution.|Null hypothesis is no difference between treatments.||6.93|-10.46|0.6888
72607917|NCT01115452|144744574|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.32||||0.9428|TWO_SIDED|95.0|-8.37|9.0||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.|Difference was calculated as adjusted mean change from baseline in 2.5% potassium nitrate solution minus water. Negative difference favored 2.5% potassium nitrate solution.|Null hypothesis is no difference between treatments.||9.00|-8.37|0.9428
72417031|NCT04794803|144344923|SUPERIORITY|||||||0.857|||||||Wilcoxon (Mann-Whitney)|||at week 1||||0.857
72417032|NCT04794803|144344923|SUPERIORITY|||||||0.436|||||||Wilcoxon (Mann-Whitney)|||at EOT||||0.436
72417033|NCT04794803|144344923|SUPERIORITY|||||||0.35|||||||Wilcoxon (Mann-Whitney)|||At EOS||||0.350
72417034|NCT04794803|144344924|SUPERIORITY|p-values are referred to a two-sided Fisher's Exact test for worsening||||||0.596|||||||Fisher Exact|||Day 1||||0.596
72417035|NCT04794803|144344924|SUPERIORITY|p-values are referred to a two-sided Fisher's Exact test for worsening||||||0.667|||||||Fisher Exact|||Day 2||||0.667
72417036|NCT04794803|144344924|SUPERIORITY|p-values are referred to a two-sided Fisher's Exact test for worsening||||||0.037|||||||Fisher Exact|||Week 1||||0.037
72607918|NCT01115452|144744575|SUPERIORITY_OR_OTHER||Adjusted mean difference|-2.58||||0.5504|TWO_SIDED|95.0|-11.1|5.95||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.|Difference was calculated as adjusted mean change from baseline in 5% potassium nitrate solution minus 2.5% potassium nitrate solution. Negative difference favored 5% potassium nitrate solution.|Null hypothesis is no difference between treatments.||5.95|-11.10|0.5504
72607919|NCT01115452|144744575|SUPERIORITY_OR_OTHER||Adjusted mean difference|-2.1||||0.634|TWO_SIDED|95.0|-10.8|6.6||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.|Difference was calculated as adjusted mean change from baseline in 5% potassium nitrate solution minus water. Negative difference favored 5% potassium nitrate solution.|Null hypothesis is no difference between treatments.||6.60|-10.80|0.6340
72607920|NCT01115452|144744575|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.48||||0.9127|TWO_SIDED|95.0|-8.2|9.16|||ANCOVA|No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|Difference was calculated as adjusted mean change from baseline in 2.5% potassium nitrate solution minus water. Negative difference favored 2.5% potassium nitrate solution.|Null hypothesis is no difference between treatments.||9.16|-8.20|0.9127
72607921|NCT01115452|144744576|SUPERIORITY_OR_OTHER||Adjusted mean difference|-2.15||||0.6192|TWO_SIDED|95.0|-10.67|6.38||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.|Difference was calculated as adjusted mean change from baseline in 5% potassium nitrate solution minus 2.5% potassium nitrate solution. Negative difference favored 5% potassium nitrate solution.|Null hypothesis is no difference between treatments.||6.38|-10.67|0.6192
72607922|NCT01115452|144744576|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.6||||0.8912|TWO_SIDED|95.0|-8.1|9.3||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.|Difference was calculated as adjusted mean change from baseline in 5% potassium nitrate solution minus water. Negative difference favored 5% potassium nitrate solution.|Null hypothesis is no difference between treatments.||9.30|-8.10|0.8912
72607923|NCT01115452|144744576|SUPERIORITY_OR_OTHER||Adjusted mean difference|2.75||||0.5321|TWO_SIDED|95.0|-5.93|11.43||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.|Difference was calculated as adjusted mean change from baseline in 2.5% potassium nitrate solution minus water. Negative difference favored 2.5% potassium nitrate solution|Null hypothesis is no difference between treatments.||11.43|-5.93|0.5321
72607924|NCT01115452|144744577|SUPERIORITY_OR_OTHER||Adjusted mean difference|-3.37||||0.4055|TWO_SIDED|95.0|-11.37|4.63||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.|Difference was calculated as adjusted mean change from baseline in 5% potassium nitrate solution minus 2.5% potassium nitrate solution. Negative difference favored 5% potassium nitrate solution.|Null hypothesis is no difference between treatments.||4.63|-11.37|0.4055
72607925|NCT01115452|144744577|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.74||||0.8573|TWO_SIDED|95.0|-7.42|8.91||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.|Difference was calculated as adjusted mean change from baseline in 5% potassium nitrate solution minus water. Negative difference favored 5% potassium nitrate solution.|Null hypothesis is no difference between treatments.||8.91|-7.42|0.8573
72607926|NCT01115452|144744577|SUPERIORITY_OR_OTHER||Adjusted mean difference|4.12||||0.3193|TWO_SIDED|95.0|-4.03|12.27||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.|Difference was calculated as adjusted mean change from baseline in 2.5% potassium nitrate solution minus water. Negative difference favored 2.5% potassium nitrate solution.|Null hypothesis is no difference between treatments.||12.27|-4.03|0.3193
72607927|NCT01115452|144744578|SUPERIORITY_OR_OTHER||Adjusted mean difference|3.23||||0.4264||95.0|-4.77|11.23||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.|Difference was calculated as adjusted mean change from baseline in 5% potassium nitrate solution minus 2.5% potassium nitrate solution. Negative difference favored 5% potassium nitrate solution.|Null hypothesis is no difference between treatments.||11.23|-4.77|0.4264
72607928|NCT01115452|144744578|SUPERIORITY_OR_OTHER||Adjusted mean difference|1.04||||0.8008|TWO_SIDED|95.0|-7.42|9.21||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.|Difference was calculated as adjusted mean change from baseline in 5% potassium nitrate solution minus water. Negative difference favored 5% potassium nitrate solution|Null hypothesis is no difference between treatments.||9.21|-7.42|0.8008
72607929|NCT01115452|144744578|SUPERIORITY_OR_OTHER||Adjusted mean difference|-2.18||||0.5969|TWO_SIDED|95.0|-10.33|5.97||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.|Difference was calculated as adjusted mean change from baseline in 2.5% potassium nitrate solution minus water. Negative difference favored 2.5% potassium nitrate solution.|Null hypothesis is no difference between treatments.||5.97|-10.33|0.5969
72607930|NCT01115452|144744579|SUPERIORITY_OR_OTHER||Adjusted mean difference|-5.14||||0.2059|TWO_SIDED|95.0|-13.14|2.86||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.|Difference was calculated as adjusted mean change from baseline in 5% potassium nitrate solution minus 2.5% potassium nitrate solution. Negative difference favored 5% potassium nitrate solution.|Null hypothesis is no difference between treatments.||2.86|-13.14|0.2059
72325362|NCT05525910|144174059|OTHER|Analysis done using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Ratio and 90% CI are expressed as percentages.|Ratio of Adjusted Geometric Means|84.11|||||TWO_SIDED|90.0|71.15|99.43||||||Reference: Nirmatrelvir/ritonavir 300(2\*150)/100 mg Test: Nirmatrelvir/ritonavir 2\*(150/50 mg) HDL||99.43|71.15|
72325363|NCT05525910|144174059|OTHER|Analysis done using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Ratio and 90% CI are expressed as percentages.|Ratio of Adjusted Geometric Means|90.99|||||TWO_SIDED|90.0|76.99|107.54||||||Reference: Nirmatrelvir/ritonavir 300(2\*150)/100 mg Test: Nirmatrelvir/ritonavir 3\*(100/33.3 mg)||107.54|76.99|
72325364|NCT05525910|144174060|OTHER|Analysis done using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Ratio and 90% CI are expressed as percentages.|Ratio (%) of Adjusted Geometric Means|82.65|||||TWO_SIDED|90.0|65.85|103.74||||||Reference: Nirmatrelvir/ritonavir 300(2\*150)/100 mg Test: Nirmatrelvir/ritonavir 2\*(150/50 mg) Low Disintegrant||103.74|65.85|
72607931|NCT01115452|144744579|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.39||||0.9248|TWO_SIDED|95.0|-8.56|7.77||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.|Difference was calculated as adjusted mean change from baseline in 5% potassium nitrate solution minus water. Negative difference favored 5% potassium nitrate solution.|Null hypothesis is no difference between treatments.||7.77|-8.56|0.9248
72607932|NCT01115452|144744579|SUPERIORITY_OR_OTHER||Adjusted mean difference|4.75||||0.2508|TWO_SIDED|95.0|-3.4|12.9||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.|Difference was calculated as adjusted mean change from baseline in 2.5% potassium nitrate solution minus water. Negative difference favored 2.5% potassium nitrate solution.|Null hypothesis is no difference between treatments.||12.90|-3.40|0.2508
72607933|NCT01115452|144744580|SUPERIORITY_OR_OTHER||Adjusted mean difference|1.12||||0.7822|TWO_SIDED|95.0|-6.86|9.1||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.|Difference was calculated as adjusted mean change from baseline in 5% potassium nitrate solution minus water. Negative difference favored 5% potassium nitrate solution.|Null hypothesis is no difference between treatments.||9.10|-6.86|0.7822
72607934|NCT01115452|144744580|SUPERIORITY_OR_OTHER||Adjusted mean difference|1.44||||0.7208|TWO_SIDED|95.0|-6.52|9.41||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.|Difference was calculated as adjusted mean change from baseline in 2.5% potassium nitrate solution minus water. Negative difference favored 2.5% potassium nitrate solution.|Null hypothesis is no difference between treatments.||9.41|-6.52|0.7208
72607935|NCT01115452|144744581|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.36||||0.7318|TWO_SIDED|95.0|-9.18|6.46||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.|Difference was calculated as adjusted mean change from baseline in 5% potassium nitrate solution minus 2.5% potassium nitrate solution. Negative difference favored 5% potassium nitrate solution.|Null hypothesis is no difference between treatments.||6.46|-9.18|0.7318
72607936|NCT01115452|144744581|SUPERIORITY_OR_OTHER||Adjusted mean difference|1.05||||0.7949|TWO_SIDED|95.0|-6.93|9.03||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.|Difference was calculated as adjusted mean change from baseline in 5% potassium nitrate solution minus water. Negative difference favored 5% potassium nitrate solution.|Null hypothesis is no difference between treatments.||9.03|-6.93|0.7949
72607937|NCT01115452|144744581|SUPERIORITY_OR_OTHER||Adjusted mean difference|2.41||||0.5507|TWO_SIDED|95.0|-5.56|10.37||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.|Difference was calculated as adjusted mean change from baseline in 2.5% potassium nitrate solution minus water. Negative difference favored 2.5% potassium nitrate solution.|Null hypothesis is no difference between treatments.||10.37|-5.56|0.5507
72607938|NCT01115452|144744582|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.72||||0.8549|TWO_SIDED|95.0|-8.54|7.1||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.|Investigator applied the participants with 5% potassium nitrate solution on each of the three individual sensitive tooth for two minutes (mins), in each of the five day treatment period|Null hypothesis is no difference between treatments.||7.10|-8.54|0.8549
72607939|NCT01115452|144744582|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.15||||0.9705|TWO_SIDED|95.0|-8.13|7.83||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.|Difference was calculated as adjusted mean change from baseline in 5% potassium nitrate solution minus water. Negative difference favored 5% potassium nitrate solution.|Null hypothesis is no difference between treatments.||7.83|-8.13|0.9705
72607940|NCT01115452|144744582|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.57||||0.8867|TWO_SIDED|95.0|-7.39|8.54||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.|Difference was calculated as adjusted mean change from baseline in 2.5% potassium nitrate solution minus water. Negative difference favored 2.5% potassium nitrate solution.|Null hypothesis is no difference between treatments.||8.54|-7.39|0.8867
72607941|NCT01674725|144744646|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The noninferiority of the rate of sustained virologic response at 12 weeks after treatment for the ABT-450/r/ABT-267 and ABT-333 treatment group as compared with the historical rate for telaprevir plus pegIFN-RBV was analyzed; the lower confidence bound of the 2-sided 95% confidence interval for the percentage of participants with sustained virologic response at 12 weeks after treatment must exceed 64% to achieve noninferiority.|Percentage of Participants|100.0|||||TWO_SIDED|95.0|95.9|100.0|||||95% CI was calculated using the Wilson score method for the single proportion because the point estimate was 100%.|Planned enrollment is 210 to allow ≥200 GT1b-infected participants to be treated with combination formulation of ABT-450/r/ABT-267 and ABT-333 with and without RBV. Enrollment terminated after 187 participants were randomized. Assuming a rate of 82% in each arm, a sample size of 90 participants per arm will have \>90% power to demonstrate noninferiority of each arm to the historical rate based on the normal approximation of a single binomial proportion in a one-sample test for superiority.||100.0|95.9|
72607942|NCT01674725|144744646|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The noninferiority of the rate of sustained virologic response at 12 weeks after treatment for the ABT-450/r/ABT-267 and ABT-333, plus RBV treatment group as compared with the historical rate for telaprevir plus pegIFN-RBV was analyzed; the lower confidence bound of the 2-sided 95% confidence interval for the percentage of participants with sustained virologic response at 12 weeks after treatment must exceed 64% to achieve noninferiority.|Percentage of Participants|97.7|||||TWO_SIDED|95.0|94.6|100.0|||||95% CI was calculated using the normal approximation to the binomial distribution.|Assuming a rate of 82% in each arm, a sample size of 90 participants per arm will have \>90% power to demonstrate noninferiority of each arm to the historical rate based on the normal approximation of a single binomial proportion in a one-sample test for superiority.||100.0|94.6|
72607943|NCT01674725|144744647|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Fisher Exact|||||||<0.001
72607944|NCT01674725|144744648|SUPERIORITY_OR_OTHER_LEGACY||Percentage of Participants|97.7|||||TWO_SIDED|95.0|94.6|100.0|||||95% CI was calculated using the normal approximation to the binomial distribution; the lower confidence bound for the percentage of participants with sustained virologic response at 12 weeks after treatment must exceed 75% to achieve superiority.|||100.0|94.6|
72607945|NCT01674725|144744648|SUPERIORITY_OR_OTHER_LEGACY||Percentage of Participants|100.0|||||TWO_SIDED|95.0|95.9|100.0|||||95% CI was calculated using the Wilson score method for the single proportion; the lower confidence bound for the percentage of participants with sustained virologic response at 12 weeks after treatment must exceed 75% to achieve superiority|||100|95.9|
72607946|NCT01674725|144744648|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The noninferiority of the rate of sustained virologic response at 12 weeks after treatment for the ABT-450/r/ABT-267 and ABT-333 treatment group as compared with the ABT-450/r/ABT-267 and ABT-333, plus RBV treatment group was analyzed using a noninferiority margin of -10.5%; the lower confidence bound of the 2-sided 95% confidence interval for the difference in percentage of participants with sustained virologic response at 12 weeks after treatment must exceed -10.5% to achieve noninferiority.|Percentage of Participants|2.3|||||TWO_SIDED|95.0|-0.8|5.4|||||95% CI was calculated using the normal approximation to the binomial distribution.|||5.4|-0.8|
72607947|NCT02900352|144744651|SUPERIORITY|||||||0.013|||||||Mixed Models Analysis|||||||0.0130
72607948|NCT02900352|144744652|SUPERIORITY|||||||0.148|||||||Chi-squared|||||||0.148
72607949|NCT02900352|144744653|SUPERIORITY|||||||0.054|||||||ANOVA|||||||.054
72607950|NCT02900352|144744654|SUPERIORITY|||||||0.035|||||||Mixed Models Analysis|||||||0.035
72607951|NCT02900352|144744655|SUPERIORITY|||||||0.889|||||||ANOVA|||||||0.889
72417037|NCT04794803|144344924|SUPERIORITY|p-values are referred to a two-sided Fisher's Exact test for worsening||||||0.293||||||p-values are referred to a two-sided Fisher's Exact test for worsening|Fisher Exact|||EOT||||0.293
72417038|NCT04794803|144344925|SUPERIORITY|||||||0.539||||||p-values are referred to a two-sided Fisher's Exact test for worsening and|Fisher Exact|||Day 1||||0.539
72607952|NCT02900352|144744656|SUPERIORITY|||||||0.482|||||||ANOVA|||||||0.482
72607953|NCT02900352|144744657|SUPERIORITY|||||||0.04|||||||ANOVA|||||||0.04
72607954|NCT03074695|144744658|OTHER||Risk Difference (RD)|3.03||||0.766|TWO_SIDED|95.0|-14.02|20.08|||Regression, Logistic|Adjusted for baseline characteristics (parturient race, ethnicity, height, and induction status).||||20.08|-14.02|0.766
72607955|NCT02337062|144744668|SUPERIORITY||||||<|0.001||||||The threshold for determining statistical significance in the comparison of incidence of success between the active and placebo groups (the primary efficacy analysis) was a p-value of 2.5% one-sided.|Chi-squared|||The primary efficacy analysis was a comparison of the incidence of the primary efficacy variable between the two groups that received APD421 and the group that received placebo, using Pearson's χ2 test.||||<0.001
72607956|NCT02337062|144744669|SUPERIORITY|||||||0.003|||||||Chi-squared|||||||0.003
72607957|NCT02337062|144744670|SUPERIORITY|||||||0.002|||||||Chi-squared|||||||0.002
72607958|NCT02337062|144744671|SUPERIORITY|||||||0.002|||||||Chi-squared|||||||0.002
72607959|NCT02337062|144744672|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
72607960|NCT02337062|144744673|SUPERIORITY||||||<|0.001|||||||Log Rank|||||||<0.001
72607961|NCT01239797|144744698|SUPERIORITY||Hazard Ratio (HR)|0.73||||0.0014|TWO_SIDED|95.0|0.6|0.89|||Log Rank|2-sided p-value for stratified log rank test||Hazard Ratio of Lenalidomide + Dexamethasone + Elotuzumab to Lenalidomide + Dexamethasone||0.89|0.60|0.0014
72607962|NCT01239797|144744699|SUPERIORITY||Hazard Ratio (HR)|0.72||||0.0005|TWO_SIDED|95.0|0.6|0.87|||Log Rank|2-sided p-value for stratified log rank test||Hazard Ratio of Lenalidomide + Dexamethasone + Elotuzumab to Lenalidomide + Dexamethasone||0.87|0.60|0.0005
72607963|NCT01239797|144744700|SUPERIORITY||Odds Ratio (OR)|1.95||||0.0002|TWO_SIDED|95.0|1.36|2.78|||Cochran-Mantel-Haenszel|Stratified by B2 microglobulin (\<3.5 mg/L vs \>=3.5 mg/L), number of prior lines of therapy (1 vs \>=2), and immunomodulatory drug use at randomization||Ratio of Lenalidomide + Dexamethasone + Elotuzumab to Lenalidomide + Dexamethasone||2.78|1.36|0.0002
72607964|NCT01239797|144744700|SUPERIORITY||Difference in ORR|12.7|||||TWO_SIDED|95.0|6.2|19.3||||||Difference of Lenalidomide + Dexamethasone + Elotuzumab minus Lenalidomide + Dexamethasone computed using the method of DerSimonian and Laird (weighted average over the strata)||19.3|6.2|
72607965|NCT02631941|144744707|EQUIVALENCE|For budesonide AUC0-last, the 90% Cls for Z7200 compared with Symbicort without and with charcoal lie entirely within the standard bioequivalence acceptance limits of (80% - 125.00%).|Adjusted geometric means ratio|100.64|||<|0.001|TWO_SIDED|90.0|95.82|105.69|||Mixed Models Analysis|||||105.69|95.82|<0.001
72607966|NCT02631941|144744707|EQUIVALENCE|For budesonide AUC0-last, the 90% Cls for Z7200 compared with Symbicort without and with charcoal lie entirely within the standard bioequivalence acceptance limits of (80% - 125.00%).|Adjusted geometric means ratio|102.11|||<|0.001|TWO_SIDED|90.0|95.55|109.13|||Mixed Models Analysis|||||109.13|95.55|<0.001
72417039|NCT04794803|144344925|SUPERIORITY|||||||1||||||p-values are referred to a two-sided Fisher's Exact test for worsening|Fisher Exact|||Day 2||||1.000
72607967|NCT02631941|144744708|EQUIVALENCE|For Formoterol AUC0-last, the 90% Cls for Z7200 compared to Symbicort without and with charcoal lie entirely within the standard bioequivalence acceptance limits of (80.00%, 125.00%).|Adjusted geometric means ratio|87.96||||0.002|TWO_SIDED|90.0|83.31|92.86|||Mixed Models Analysis|||||92.86|83.31|0.002
72607968|NCT02631941|144744708|EQUIVALENCE|For Formoterol AUC0-last, the 90% Cls for Z7200 compared to Symbicort without and with charcoal lie entirely within the standard bioequivalence acceptance limits of (80.00%, 125.00%).|Adjusted geometric means ratio|91.17||||0.005|TWO_SIDED|90.0|83.94|99.04|||Mixed Models Analysis|||||99.04|83.94|0.005
72607969|NCT02631941|144744709|EQUIVALENCE|For Budesonide Cmax, the 90% Cls for Z7200 compared with Symbicort without and with charcoal do not lie entirely within the wider bioequivalence acceptance limits of ( 73.74%, 135.62%) and standard bioequivalence acceptance limits of (80.00%, 125.00%), respectively.|Adjusted geometric means ratio|157.86||||1|TWO_SIDED|90.0|144.12|172.91|||Mixed Models Analysis|||||172.91|144.12|1.00
72607970|NCT02631941|144744709|EQUIVALENCE|For Budesonide Cmax, the 90% Cls for Z7200 compared with Symbicort without and with charcoal do not lie entirely within the wider bioequivalence acceptance limits of ( 73.74%, 135.62%) and standard bioequivalence acceptance limits of (80.00%, 125.00%), respectively.|Adjusted geometric means ratio|166.81||||1|TWO_SIDED|90.0|148.35|187.57|||Mixed Models Analysis|||||187.57|148.35|1.00
72417040|NCT04794803|144344925|SUPERIORITY|||||||0.102||||||p-values are referred to a two-sided Fisher's Exact test for worsening|Fisher Exact|||Week 1||||0.102
72417041|NCT04794803|144344925|SUPERIORITY|||||||0.119||||||p-values are referred to a two-sided Fisher's Exact test for worsening|Fisher Exact|||EOT||||0.119
72417042|NCT04794803|144344925|SUPERIORITY|||||||0.515||||||p-values are referred to a two-sided Fisher's Exact test for worsening|Fisher Exact|||EOS||||0.515
72417043|NCT04794803|144344926|SUPERIORITY|||||||0.366||||||p-values are referred to a two-sided Wilcoxon test for cumulative duration.|Wilcoxon (Mann-Whitney)|||Week 1||||0.366
72607971|NCT02631941|144744710|EQUIVALENCE|For Formoterol Cmax, the 90% Cl for Z7200 compared to Symbicort without and with charcoal lie entirely within the wider bioequivalence acceptance limits of (77.65%, 128.79%) and standard bioequivalence acceptance limits of (80.00%, 125.00%), respectively.|Adjusted geometric means ratio|85.22||||0.012|TWO_SIDED|90.0|79.66|91.17|||Mixed Models Analysis|||||91.17|79.66|0.012
72607972|NCT02631941|144744710|EQUIVALENCE|For Formoterol Cmax, the 90% Cl for Z7200 compared to Symbicort without and with charcoal lie entirely within the wider bioequivalence acceptance limits of (77.65%, 128.79%) and standard bioequivalence acceptance limits of (80.00%, 125.00%), respectively.|Adjusted geometric means ratio|87.74||||0.02|TWO_SIDED|90.0|81.48|94.47|||Mixed Models Analysis|||||94.47|81.48|0.020
72607973|NCT02858401|144744738|OTHER|||||||0.1498|||||||Wilcoxon rank sum test|||||||0.1498
72607974|NCT02858401|144744738|OTHER|||||||0.064|||||||Wilcoxon rank sum test|||||||0.0640
72417044|NCT04794803|144344926|SUPERIORITY|||||||0.489||||||p-values are referred to a two-sided Wilcoxon test for cumulative duration.|Wilcoxon (Mann-Whitney)|||EOT||||0.489
72607975|NCT02858401|144744738|OTHER|||||||0.2807|||||||Wilcoxon rank sum test|||||||0.2807
72607976|NCT02858401|144744738|OTHER|||||||0.1228|||||||Wilcoxon rank sum test|||||||0.1228
72607977|NCT02858401|144744738|OTHER|||||||0.0289|||||||Wilcoxon rank sum test|||||||0.0289
72607978|NCT02858401|144744738|OTHER|||||||0.5895|||||||Wilcoxon rank sum test|||||||0.5895
72607979|NCT02858401|144744739|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
72607980|NCT02858401|144744739|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
72607981|NCT02858401|144744739|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
72607982|NCT02858401|144744740|OTHER|||||||0.5557|||||||Wilcoxon rank sum test|||||||0.5557
72607983|NCT02858401|144744740|OTHER|||||||0.5557|||||||Wilcoxon rank sum test|||||||0.5557
72607984|NCT02858401|144744740|OTHER|||||||0.8288|||||||Wilcoxon rank sum test|||||||0.8288
72607985|NCT02858401|144744740|OTHER|||||||0.5557|||||||Wilcoxon rank sum test|||||||0.5557
72607986|NCT02858401|144744740|OTHER|||||||0.6056|||||||Wilcoxon rank sum test|||||||0.6056
72607987|NCT02858401|144744740|OTHER|||||||0.5557|||||||Wilcoxon rank sum test|||||||0.5557
72607988|NCT02858401|144744741|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
72607989|NCT02858401|144744741|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
72607990|NCT02858401|144744741|OTHER|||||||0.4047|||||||Wilcoxon rank sum test|||||||0.4047
72607991|NCT02858401|144744742|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
72607992|NCT02858401|144744742|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
72607993|NCT02858401|144744742|OTHER|||||||0.1556|||||||Wilcoxon rank sum test|||||||0.1556
72607994|NCT02858401|144744742|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
72607995|NCT02858401|144744742|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
72607996|NCT02858401|144744742|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
72607997|NCT02858401|144744743|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
72417045|NCT04794803|144344926|SUPERIORITY|||||||0.486||||||p-values are referred to a two-sided Wilcoxon test for cumulative duration.|Wilcoxon (Mann-Whitney)|||EOS||||0.486
72417046|NCT04794803|144344927|SUPERIORITY|||||||0.79||||||p-values are referred to a two-sided Wilcoxon test for cumulative quantity|Wilcoxon (Mann-Whitney)|||Week 1||||0.790
72417047|NCT04794803|144344927|SUPERIORITY|||||||0.961||||||p-values are referred to a two-sided Wilcoxon test for cumulative quantity|Wilcoxon (Mann-Whitney)|||EOT||||0.961
72417048|NCT04794803|144344927|SUPERIORITY|||||||0.619||||||p-values are referred to a two-sided Wilcoxon test for cumulative quantity|Wilcoxon (Mann-Whitney)|||EOS||||0.619
72607998|NCT02858401|144744743|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
72607999|NCT02858401|144744743|OTHER|||||||0.3613|||||||Wilcoxon rank sum test|||||||0.3613
72608000|NCT02858401|144744744|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
72608001|NCT02858401|144744744|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
72608002|NCT02858401|144744744|OTHER|||||||0.1949|||||||Wilcoxon rank sum test|||||||0.1949
72608003|NCT02858401|144744744|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
72608004|NCT02858401|144744744|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
72608005|NCT02858401|144744744|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
72608006|NCT02858401|144744745|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
72608007|NCT02858401|144744745|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
72608008|NCT02858401|144744745|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
72608009|NCT02858401|144744746|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
72608010|NCT02858401|144744746|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
72608011|NCT02858401|144744746|OTHER|||||||0.4047|||||||Wilcoxon rank sum test|||||||0.4047
72608012|NCT02858401|144744747|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
72608013|NCT02858401|144744747|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
72608014|NCT02858401|144744747|OTHER|||||||0.1556|||||||Wilcoxon rank sum test|||||||0.1556
72608015|NCT02858401|144744747|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
72608016|NCT02858401|144744747|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
72608017|NCT02858401|144744747|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
72608018|NCT02858401|144744748|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
72608019|NCT02858401|144744748|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
72608020|NCT02858401|144744748|OTHER|||||||0.4047|||||||Wilcoxon rank sum test|||||||0.4047
72608021|NCT02858401|144744749|OTHER|||||||0.1949|||||||Wilcoxon rank sum test|||||||0.1949
72608022|NCT02858401|144744749|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
72608023|NCT02858401|144744749|OTHER|||||||0.4278|||||||Wilcoxon rank sum test|||||||0.4278
72608024|NCT02858401|144744749|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
72608025|NCT02858401|144744749|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
72608026|NCT02858401|144744749|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
72608027|NCT02858401|144744750|OTHER|||||||0.5186|||||||Wilcoxon rank sum test|||||||0.5186
72608028|NCT02858401|144744750|OTHER|||||||0.5716|||||||Wilcoxon rank sum test|||||||0.5716
72608029|NCT02858401|144744750|OTHER|||||||0.1869|||||||Wilcoxon rank sum test|||||||0.1869
72608030|NCT02858401|144744750|OTHER|||||||0.5186|||||||Wilcoxon rank sum test|||||||0.5186
72608031|NCT02858401|144744750|OTHER|||||||0.5186|||||||Wilcoxon rank sum test|||||||0.5186
72608032|NCT02858401|144744751|OTHER|||||||0.3613|||||||Wilcoxon rank sum test|||||||0.3613
72608033|NCT02858401|144744751|OTHER|||||||0.4237|||||||Wilcoxon rank sum test|||||||0.4237
72608034|NCT02858401|144744751|OTHER|||||||0.223|||||||Wilcoxon rank sum test|||||||0.2230
72608035|NCT02858401|144744752|OTHER|||||||0.3456|||||||Wilcoxon rank sum test|||||||0.3456
72608036|NCT02858401|144744752|OTHER|||||||0.3971|||||||Wilcoxon rank sum test|||||||0.3971
72608037|NCT02858401|144744752|OTHER|||||||0.1301|||||||Wilcoxon rank sum test|||||||0.1301
72608038|NCT02858401|144744752|OTHER|||||||0.3456|||||||Wilcoxon rank sum test|||||||0.3456
72608039|NCT02858401|144744752|OTHER|||||||0.3456|||||||Wilcoxon rank sum test|||||||0.3456
72608040|NCT02858401|144744752|OTHER|||||||0.3456|||||||Wilcoxon rank sum test|||||||0.3456
72417049|NCT04794803|144344928|SUPERIORITY|||||||1||||||p-values are referred to a two-sided Fisher's Exact test for proportion|Fisher Exact|||Baseline||||1.000
72608041|NCT02858401|144744753|OTHER|||||||0.4047|||||||Wilcoxon rank sum test|||||||0.4047
72608042|NCT02858401|144744753|OTHER|||||||0.4652|||||||Wilcoxon rank sum test|||||||0.4652
72608043|NCT02858401|144744753|OTHER|||||||0.5993|||||||Wilcoxon rank sum test|||||||0.5993
72608044|NCT02858401|144744754|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
72608045|NCT02858401|144744754|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
72608046|NCT02858401|144744754|OTHER|||||||0.1949|||||||Wilcoxon rank sum test|||||||0.1949
72608047|NCT02858401|144744754|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
72608048|NCT02858401|144744754|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
72608049|NCT02858401|144744754|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
72608050|NCT02858401|144744755|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
72608051|NCT02858401|144744755|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
72608052|NCT02858401|144744755|OTHER|||||||0.2763|||||||Wilcoxon rank sum test|||||||0.2763
72608053|NCT02858401|144744755|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
72608054|NCT02858401|144744755|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
72608055|NCT02858401|144744756|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
72417050|NCT04794803|144344928|SUPERIORITY|||||||1||||||p-values are referred to a two-sided Fisher's Exact test for proportion|Fisher Exact|||Day 1||||1.000
72417051|NCT04794803|144344928|SUPERIORITY|||||||0.678||||||p-values are referred to a two-sided Fisher's Exact test for proportion|Fisher Exact|||Day 2||||0.678
72417052|NCT04794803|144344928|SUPERIORITY|||||||1||||||p-values are referred to a two-sided Fisher's Exact test for proportion|Fisher Exact|||Week 1||||1.000
72417053|NCT04794803|144344928|SUPERIORITY|||||||1||||||p-values are referred to a two-sided Fisher's Exact test for proportion|Fisher Exact|||EOT||||1.000
72608056|NCT02858401|144744756|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
72608057|NCT02858401|144744756|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
72608058|NCT02858401|144744757|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
72608059|NCT02858401|144744757|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
72608060|NCT02858401|144744757|OTHER|||||||0.1949|||||||Wilcoxon rank sum test|||||||0.1949
72608061|NCT02858401|144744757|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
72608062|NCT02858401|144744757|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
72608063|NCT02858401|144744757|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
72608064|NCT02858401|144744758|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
72608065|NCT02858401|144744758|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
72608066|NCT02858401|144744758|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
72608067|NCT02858401|144744759|OTHER|||||||0.5383|||||||Wilcoxon rank sum test|||||||0.5383
72608068|NCT02858401|144744759|OTHER|||||||0.5896|||||||Wilcoxon rank sum test|||||||0.5896
72608069|NCT02858401|144744759|OTHER|||||||0.8207|||||||Wilcoxon rank sum test|||||||0.8207
72608070|NCT02858401|144744759|OTHER|||||||0.5383|||||||Wilcoxon rank sum test|||||||0.5383
72608071|NCT02858401|144744759|OTHER|||||||0.5383|||||||Wilcoxon rank sum test|||||||0.5383
72608072|NCT02858401|144744759|OTHER|||||||0.5383|||||||Wilcoxon rank sum test|||||||0.5383
72608073|NCT02858401|144744760|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
72608074|NCT02858401|144744760|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
72608075|NCT02858401|144744760|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
72608076|NCT02858401|144744761|OTHER|||||||0.3237|||||||Wilcoxon rank sum test|||||||0.3237
72608077|NCT02858401|144744761|OTHER|||||||0.3755|||||||Wilcoxon rank sum test|||||||0.3755
72608078|NCT02858401|144744761|OTHER|||||||0.4577|||||||Wilcoxon rank sum test|||||||0.4577
72608079|NCT02858401|144744761|OTHER|||||||0.3237|||||||Wilcoxon rank sum test|||||||0.3237
72608080|NCT02858401|144744761|OTHER|||||||0.3237|||||||Wilcoxon rank sum test|||||||0.3237
72608081|NCT02858401|144744761|OTHER|||||||0.3237|||||||Wilcoxon rank sum test|||||||0.3237
72608082|NCT02858401|144744762|OTHER|||||||0.4047|||||||Wilcoxon rank sum test|||||||0.4047
72608083|NCT02858401|144744762|OTHER|||||||0.4652|||||||Wilcoxon rank sum test|||||||0.4652
72608084|NCT02858401|144744762|OTHER|||||||0.7526|||||||Wilcoxon rank sum test|||||||0.7526
72608085|NCT02858401|144744763|OTHER|||||||0.5546|||||||Wilcoxon rank sum test|||||||0.5546
72608086|NCT02858401|144744763|OTHER|||||||0.6937|||||||Wilcoxon rank sum test|||||||0.6937
72608087|NCT02858401|144744763|OTHER|||||||0.8207|||||||Wilcoxon rank sum test|||||||0.8207
72608088|NCT02858401|144744763|OTHER|||||||0.5383|||||||Wilcoxon rank sum test|||||||0.5383
72608089|NCT02858401|144744763|OTHER|||||||0.5383|||||||Wilcoxon rank sum test|||||||0.5383
72608090|NCT02858401|144744763|OTHER|||||||0.7878|||||||Wilcoxon rank sum test|||||||0.7878
72608091|NCT02858401|144744764|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
72608092|NCT02858401|144744764|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
72608093|NCT02858401|144744764|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
72608094|NCT02858401|144744765|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
72608095|NCT02858401|144744765|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
72608096|NCT02858401|144744765|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
72608097|NCT02858401|144744765|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
72608098|NCT02858401|144744765|OTHER|||||||1|||||||Wilcoxon (Mann-Whitney)|||||||1.0000
72608099|NCT02858401|144744765|OTHER|||||||0.1949|||||||Wilcoxon rank sum test|||||||0.1949
72608100|NCT02858401|144744766|OTHER|||||||0.5186|||||||Wilcoxon rank sum test|||||||0.5186
72608101|NCT02858401|144744766|OTHER|||||||0.5716|||||||Wilcoxon rank sum test|||||||0.5716
72608102|NCT02858401|144744766|OTHER|||||||0.6908|||||||Wilcoxon rank sum test|||||||0.6908
72608103|NCT02858401|144744766|OTHER|||||||0.5186|||||||Wilcoxon rank sum test|||||||0.5186
72608104|NCT02858401|144744766|OTHER|||||||0.5186|||||||Wilcoxon rank sum test|||||||0.5186
72608105|NCT02858401|144744767|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
72608106|NCT02858401|144744767|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
72608107|NCT02858401|144744767|OTHER|||||||0.4047|||||||Wilcoxon rank sum test|||||||0.4047
72608108|NCT02858401|144744768|OTHER|||||||0.5383|||||||Wilcoxon rank sum test|||||||0.5383
72608109|NCT02858401|144744768|OTHER|||||||0.5896|||||||Wilcoxon rank sum test|||||||0.5896
72608110|NCT02858401|144744768|OTHER|||||||0.1784|||||||Wilcoxon rank sum test|||||||0.1784
72608111|NCT02858401|144744768|OTHER|||||||0.5383|||||||Wilcoxon rank sum test|||||||0.5383
72608112|NCT02858401|144744768|OTHER|||||||0.5383|||||||Wilcoxon rank sum test|||||||0.5383
72608113|NCT02858401|144744768|OTHER|||||||0.5383|||||||Wilcoxon rank sum test|||||||0.5383
72608114|NCT02858401|144744769|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
72608115|NCT02858401|144744769|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
72608116|NCT02858401|144744769|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
72608117|NCT02858401|144744770|OTHER|||||||0.4047|||||||Wilcoxon rank sum test|||||||0.4047
72608118|NCT02858401|144744770|OTHER|||||||0.4047|||||||Wilcoxon rank sum test|||||||0.4047
72608119|NCT02858401|144744770|OTHER|||||||0.4047|||||||Wilcoxon rank sum test|||||||0.4047
72608120|NCT02858401|144744771|OTHER|||||||0.3074|||||||Wilcoxon rank sum test|||||||0.3074
72608121|NCT02858401|144744771|OTHER|||||||0.3074|||||||Wilcoxon rank sum test|||||||0.3074
72608122|NCT02858401|144744772|OTHER|||||||0.4047|||||||Wilcoxon rank sum test|||||||0.4047
72608123|NCT02858401|144744772|OTHER|||||||0.4047|||||||Wilcoxon rank sum test|||||||0.4047
72608124|NCT02858401|144744772|OTHER|||||||0.4047|||||||Wilcoxon rank sum test|||||||0.4047
72608125|NCT02858401|144744773|OTHER|||||||0.1757|||||||Wilcoxon rank sum test|||||||0.1757
72608126|NCT02858401|144744773|OTHER|||||||0.1757|||||||Wilcoxon rank sum test|||||||0.1757
72608127|NCT02858401|144744773|OTHER|||||||0.5993|||||||Wilcoxon rank sum test|||||||0.5993
72608128|NCT02858401|144744774|OTHER|||||||0.8504|||||||Wilcoxon rank sum test|||||||0.8504
72608129|NCT02858401|144744774|OTHER|||||||0.5716|||||||Wilcoxon rank sum test|||||||0.5716
72608130|NCT02858401|144744774|OTHER|||||||0.6908|||||||Wilcoxon rank sum test|||||||0.6908
72608131|NCT02858401|144744774|OTHER|||||||0.5186|||||||Wilcoxon rank sum test|||||||0.5186
72608132|NCT02858401|144744774|OTHER|||||||0.5186|||||||Wilcoxon rank sum test|||||||0.5186
72608133|NCT02858401|144744775|OTHER|||||||0.4047|||||||Wilcoxon rank sum test|||||||0.4047
72608134|NCT02858401|144744775|OTHER|||||||0.4047|||||||Wilcoxon rank sum test|||||||0.4047
72608135|NCT02858401|144744775|OTHER|||||||0.4047|||||||Wilcoxon rank sum test|||||||0.4047
72608136|NCT02858401|144744776|OTHER|||||||0.4047|||||||Wilcoxon rank sum test|||||||0.4047
72608137|NCT02858401|144744776|OTHER|||||||0.4047|||||||Wilcoxon rank sum test|||||||0.4047
72608138|NCT02858401|144744776|OTHER|||||||0.4047|||||||Wilcoxon rank sum test|||||||0.4047
72608139|NCT02858401|144744777|OTHER|||||||0.3074|||||||Wilcoxon rank sum test|||||||0.3074
72608140|NCT02858401|144744777|OTHER|||||||0.3074|||||||Wilcoxon rank sum test|||||||0.3074
72608141|NCT02858401|144744778|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
72608142|NCT02858401|144744778|OTHER|||||||0.4047|||||||Wilcoxon rank sum test|||||||0.4047
72608143|NCT02858401|144744778|OTHER|||||||0.4047|||||||Wilcoxon rank sum test|||||||0.4047
72608144|NCT02858401|144744779|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
72608145|NCT02858401|144744779|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
72608146|NCT02858401|144744779|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
72608147|NCT02858401|144744780|OTHER|||||||0.1757|||||||Wilcoxon rank sum test|||||||0.1757
72608148|NCT02858401|144744780|OTHER|||||||0.1757|||||||Wilcoxon rank sum test|||||||0.1757
72608149|NCT02858401|144744780|OTHER|||||||0.223|||||||Wilcoxon rank sum test|||||||0.2230
72608150|NCT02858401|144744781|OTHER|||||||0.4047|||||||Wilcoxon rank sum test|||||||0.4047
72608151|NCT02858401|144744781|OTHER|||||||0.4047|||||||Wilcoxon rank sum test|||||||0.4047
72608152|NCT02858401|144744781|OTHER|||||||0.4652|||||||Wilcoxon rank sum test|||||||0.4652
72608153|NCT02858401|144744782|OTHER|||||||0.4047|||||||Wilcoxon rank sum test|||||||0.4047
72608154|NCT02858401|144744782|OTHER|||||||0.4047|||||||Wilcoxon rank sum test|||||||0.4047
72608155|NCT02858401|144744782|OTHER|||||||0.4652|||||||Wilcoxon rank sum test|||||||0.4652
72608156|NCT02858401|144744783|OTHER|||||||0.1757|||||||Wilcoxon rank sum test|||||||0.1757
72608157|NCT02858401|144744783|OTHER|||||||0.1757|||||||Wilcoxon rank sum test|||||||0.1757
72608158|NCT02858401|144744783|OTHER|||||||0.223|||||||Wilcoxon rank sum test|||||||0.2230
72608159|NCT02858401|144744786|OTHER|||||||1|||||||Fisher Exact|||||||1.0000
72608160|NCT02858401|144744786|OTHER|||||||1|||||||Fisher Exact|||||||1.0000
72608161|NCT02858401|144744786|OTHER|||||||1|||||||Fisher Exact|||||||1.0000
72608162|NCT02858401|144744786|OTHER|||||||1|||||||Fisher Exact|||||||1.0000
72608163|NCT02858401|144744786|OTHER|||||||1|||||||Fisher Exact|||||||1.0000
72608164|NCT02858401|144744786|OTHER|||||||1|||||||Fisher Exact|||||||1.0000
72608165|NCT02858401|144744787|OTHER|||||||0.3333|||||||Fisher Exact|||||||0.3333
72608166|NCT02858401|144744788|OTHER|||||||1|||||||Fisher Exact|||||||1.0000
72608167|NCT02858401|144744788|OTHER|||||||1|||||||Fisher Exact|||||||1.0000
72608168|NCT02858401|144744788|OTHER|||||||1|||||||Fisher Exact|||||||1.0000
72608169|NCT02858401|144744788|OTHER|||||||1|||||||Fisher Exact|||||||1.0000
72608170|NCT02858401|144744788|OTHER|||||||1|||||||Fisher Exact|||||||1.0000
72608171|NCT02858401|144744788|OTHER|||||||1|||||||Fisher Exact|||||||1.0000
72608172|NCT02858401|144744789|OTHER|||||||1|||||||Fisher Exact|||||||1.0000
72608173|NCT02858401|144744789|OTHER|||||||1|||||||Fisher Exact|||||||1.0000
72608174|NCT02858401|144744789|OTHER|||||||1|||||||Fisher Exact|||||||1.0000
72608175|NCT02858401|144744789|OTHER|||||||1|||||||Fisher Exact|||||||1.0000
72608176|NCT02858401|144744789|OTHER|||||||1|||||||Fisher Exact|||||||1.0000
72608177|NCT02858401|144744789|OTHER|||||||1|||||||Fisher Exact|||||||1.0000
72608178|NCT02858401|144744790|OTHER|||||||1|||||||Fisher Exact|||||||1.0000
72608179|NCT02858401|144744790|OTHER|||||||1|||||||Fisher Exact|||||||1.0000
72608180|NCT02858401|144744790|OTHER|||||||1|||||||Fisher Exact|||||||1.0000
72608181|NCT02858401|144744791|OTHER|||||||1|||||||Fisher Exact|||||||1.0000
72608182|NCT02858401|144744791|OTHER|||||||1|||||||Fisher Exact|||||||1.0000
72608183|NCT02858401|144744791|OTHER|||||||1|||||||Fisher Exact|||||||1.0000
72608184|NCT02858401|144744793|OTHER|||||||1|||||||Fisher Exact|||||||1.0000
72608185|NCT02858401|144744793|OTHER|||||||1|||||||Fisher Exact|||||||1.0000
72608186|NCT02858401|144744793|OTHER|||||||1|||||||Fisher Exact|||||||1.0000
72608187|NCT02513550|144744794|SUPERIORITY||Risk Difference (RD)|7.9|||=|0.005|TWO_SIDED||||||Regression, Logistic|||||||=0.005
72608188|NCT02513550|144744794|SUPERIORITY||Risk Difference (RD)|1.9|||=|0.522|TWO_SIDED||||||Regression, Logistic|||||||=0.522
72608189|NCT02513550|144744795|SUPERIORITY||Risk Difference (RD)|6.9|||=|0.006|TWO_SIDED||||||Regression, Logistic|||||||=0.006
72608190|NCT02513550|144744795|SUPERIORITY||Risk Difference (RD)|4.6|||=|0.118|TWO_SIDED||||||Regression, Logistic|||||||=0.118
72608191|NCT00678418|144744829|SUPERIORITY_OR_OTHER|||||||0.0002||95.0|||||Van der Waerden|||Null hypothesis = the distribution function of opioid-free weeks is the same for both treatment groups.||||0.0002
72608192|NCT00678418|144744830|SUPERIORITY_OR_OTHER|||||||0.0042||95.0||||A total of 114 subjects continued on-study beyond the 168-day endpoint for Part A; these subjects were censored as of the first dosing day in Part B.|Kaplan Meier|||P-value was calculated using the log-rank test for the null hypothesis: the distribution of days to discontinuation does not differ by treatment.||||0.0042
72608193|NCT00678418|144744831|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|95.0|||||Chi-squared|||"P-value was calculated using the Chi-square test for the null hypothesis: mean treatment difference = 0.~Calculations were based on the Generalized Estimating Equation (GEE) model (normal distribution, identity link and AR(1) correlation structure) for repeated data on change from baseline with treatment and visit as main effects, and baseline as a covariate. Missing data were imputed using the Last Observation Carried Forward (LOCF) method."||||<0.0001
72608194|NCT00678418|144744832|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.75||||0.0154||95.0|0.6|0.95|||Chi-squared|||"Chi-square test was used to calculate the p-value for treatment. Null hypothesis = no association between relapse to dependence and study treatment.~Subjects who discontinued prematurely from the study were imputed as having a positive naloxone challenge test result."||0.95|0.60|0.0154
72608195|NCT00678418|144744833|SUPERIORITY_OR_OTHER|||||||0.0031||95.0|||||van der Waerden|||Null hypothesis: Treatment difference=0. Missing data from subjects due to early discontinuation during Part A were imputed using the baseline rate; thus data for subjects who discontinued early were imputed as having no change from baseline.||||0.0031
72608196|NCT03924323|144744834|SUPERIORITY||least squares mean difference|-1.42||||0.0281|TWO_SIDED|95.0|-2.69|-0.15|||mixed-effects model for repeated measure|||||-0.15|-2.69|0.0281
72608197|NCT03924323|144744835|SUPERIORITY||Odds Ratio (OR)|1.253||||0.4521|TWO_SIDED|95.0|0.695|2.258|||generalized linear mixed model (GLMMIX)|||||2.258|0.695|0.4521
72608198|NCT03924323|144744836|SUPERIORITY||Odds Ratio (OR)|1.157||||0.6928|TWO_SIDED|95.0|0.56|2.387|||generalized linear mixed model (GLMMIX)|||||2.387|0.560|0.6928
72325365|NCT05525910|144174060|OTHER|Analysis done using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Ratio and 90% CI are expressed as percentages.|Ratio (%) of Adjusted Geometric Means|94.85|||||TWO_SIDED|90.0|75.28|119.49||||||Reference: Nirmatrelvir/ritonavir 300(2\*150)/100 mg Test: Nirmatrelvir/ritonavir 2\*(150/50 mg) High Disintegrant||119.49|75.28|
72608199|NCT03834493|144744839|SUPERIORITY||Hazard Ratio (HR)|1.04||||0.6621|TWO_SIDED|95.0|0.88|1.22|||Log Rank||Stratified Cox model with Efron's tie handling method|||1.22|0.88|0.6621
72608200|NCT03834493|144744840|SUPERIORITY||Hazard Ratio (HR)|0.98||||0.4073|TWO_SIDED|95.0|0.84|1.14|||Log Rank||Stratified Cox model with Efron's tie handling method|||1.14|0.84|0.4073
72608201|NCT03834493|144744841|OTHER||Hazard Ratio (HR)|0.95|||||TWO_SIDED|95.0|0.83|1.09|||||Stratified Cox model with Efron's tie handling method|||1.09|0.83|
72325366|NCT05525910|144174060|OTHER|Analysis done using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Ratio and 90% CI are expressed as percentages.|Ratio of Adjusted Geometric Means|81.56|||||TWO_SIDED|90.0|65.18|102.07||||||Reference: Nirmatrelvir/ritonavir 300(2\*150)/100 mg Test: Nirmatrelvir/ritonavir 2\*(150/50 mg) HDL||102.07|65.18|
72608202|NCT03834493|144744842|OTHER||Difference in Percentage|3.4|||||TWO_SIDED|95.0|-1.5|8.3|||||Stratified Miettinen and Nurminen method|||8.3|-1.5|
72608203|NCT03834493|144744843|OTHER||Difference in Percentage|0.3|||||TWO_SIDED|95.0|-3.4|4.1|||||Stratified Miettinen and Nurminen method|||4.1|-3.4|
72608204|NCT03834493|144744844|OTHER||Difference in Percentage|2.9|||||TWO_SIDED|95.0|-0.2|6.1|||||Stratified Miettinen and Nurminen method|||6.1|-0.2|
72608205|NCT03834493|144744846|OTHER||Hazard Ratio (HR)|0.99|||||TWO_SIDED|95.0|0.86|1.15|||||Stratified Cox model with Efron's tie handling method|||1.15|0.86|
72608206|NCT03834493|144744847|OTHER||Hazard Ratio (HR)|0.9|||||TWO_SIDED|95.0|0.74|1.09|||||Stratified Cox model with Efron's tie handling method|||1.09|0.74|
72608207|NCT03834493|144744848|OTHER||Hazard Ratio (HR)|1.05|||||TWO_SIDED|95.0|0.82|1.35|||||Stratified Cox model with Efron's tie handling method|||1.35|0.82|
72608208|NCT03834493|144744849|OTHER||Hazard Ratio (HR)|1.13|||||TWO_SIDED|95.0|0.85|1.51|||||Stratified Cox model with Efron's tie handling method|||1.51|0.85|
72608209|NCT02756910|144744852|OTHER||percentile method|0.5|STANDARD_DEVIATION|1.96|<|0.05|TWO_SIDED|95.0|||||bootstrapping|||||||<0.05
72608210|NCT03829462|144744867|SUPERIORITY||Hazard Ratio (HR)|1.18||||0.5334|TWO_SIDED|95.0|0.7|1.98||The threshold for statistical significance was p=0.05|Log Rank|||To show an increase of median overall survival from 7 to 15 months (30% to 57% rates, respectively), with a HR=0.47 and a power of 80% and alpha=5%, 55 events are required for the 78 patients to be randomized considering 15% additional patients for lost to follow-up.||1.98|0.7|0.5334
72608211|NCT03829462|144744867|SUPERIORITY||Hazard Ratio (HR)|1.04||||0.8894|TWO_SIDED|95.0|0.59|1.82|||Chi-squared|||||1.82|0.59|0.8894
72608212|NCT03829462|144744868|SUPERIORITY||Hazard Ratio (HR)|0.67||||0.1104|TWO_SIDED|95.0|0.4|1.11|||Log Rank|The threshold for statistical significance was p=0.05||||1.11|0.4|0.1104
72608213|NCT03829462|144744868|SUPERIORITY||Hazard Ratio (HR)|0.67||||0.1165|TWO_SIDED|95.0|0.4|1.11|||Chi-squared|||||1.11|0.4|0.1165
72325367|NCT05525910|144174060|OTHER|Analysis done using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Ratio and 90% CI are expressed as percentages.|Ratio of Adjusted Geometric Means|88.38|||||TWO_SIDED|90.0|70.65|110.57||||||Reference: Nirmatrelvir/ritonavir 300(2\*150)/100 mg Test: Nirmatrelvir/ritonavir 3\*(100/33.3 mg)||110.57|70.65|
72325368|NCT01247064|144174077|SUPERIORITY_OR_OTHER|||||||0.01|||||||t-test, 2 sided|||||||0.01
72608214|NCT03829462|144744869|SUPERIORITY||Hazard Ratio (HR)|0.61||||0.2425|TWO_SIDED|95.0|0.26|1.42||The threshold for statistical significance was p=0.05|Log Rank|||||1.42|0.26|0.2425
72325369|NCT01247064|144174078|SUPERIORITY_OR_OTHER|||||||0.86|||||||Chi-squared|||||||0.86
72325370|NCT01247064|144174079|SUPERIORITY_OR_OTHER|||||||0.02|||||||t-test, 2 sided|||||||0.02
72608215|NCT03829462|144744869|SUPERIORITY||Hazard Ratio (HR)|0.61||||0.2519|TWO_SIDED|95.0|0.26|1.42|||Chi-squared|||||1.42|0.26|0.2519
72608216|NCT03829462|144744870|SUPERIORITY||Percent difference|46.5||||0.001|TWO_SIDED||||||Fisher Exact|||||||0.001
72608217|NCT03829462|144744871|SUPERIORITY||Percent difference|7.4||||0.001|TWO_SIDED||||||Fisher Exact|||||||0.001
72608218|NCT00359203|144744891|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.43||||0.04|TWO_SIDED|95.0|0.19|0.96|||Log Rank|The risk of syncope recurrence was based on HR obtained by means of the univarate Cox model, with the use of the Breslow method for ties.|numerator=pacemaker ON denominator=pacemaker OFF|The analysis was designed to have 80% power to detect a 1-year absolute reduction of 25% in the risk of recurrence of first syncope in the Pm ON arm applying a log-rank test with a 2-sided significance level of 0.05. This analysis was planned as a comparison of the cumulative risk of syncope between the 2 groups with the use of a log-rank test.||0.96|0.19|0.04
72608219|NCT00359203|144744891|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The analysis was designed to have 80% power to detect a 1-year absolute reduction of 25% in the risk of recurrence of first syncope in the treatment arm applying a log-rank test with a 2-sided significance level of 0.05.|Hazard Ratio (HR)|0.43||||0.039|TWO_SIDED|95.0|0.19|0.96||For the final analysis the threshold of statistical significance was set at 0.04.|Log Rank||Numerator=pacemaker ON denominator=pacemaker OFF|||0.96|0.19|0.039
72608220|NCT01764841|144744918|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.7331||||0.065|TWO_SIDED|97.5|0.5027|1.069|||Wald-type test|||The hazard ratio for time to first exacerbation event within 48 weeks and 97.5% Confidence Interval (CI) was calculated by using Cox proportional hazards model by comparison of Cipro 28/Pooled Placebo reporting groups. P-value was analysed using Wald-type test.||1.0690|0.5027|0.0650
72608221|NCT01764841|144744918|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.5333||||0.0005|TWO_SIDED|97.5|0.3568|0.7971|||Wald-type test|||The hazard ratio for time to first exacerbation event within 48 weeks and 97.5% CI was calculated by using Cox proportional hazards model by comparison of Cipro 14/Pooled Placebo reporting groups. P-value was analysed using Wald-type test.||0.7971|0.3568|0.0005
72608222|NCT01764841|144744919|SUPERIORITY_OR_OTHER||Incidence Rate Ratio|0.8615||||0.2944|TWO_SIDED|97.5|0.6264|1.1848|||Poisson regression|||A Poisson regression with adjustment for over-/under dispersion was used to analyze the number of exacerbation events over 48 weeks and to test the difference in the frequency of exacerbation between Ciprofloxacin DPI 28 and Pooled placebo group. P-value was analyzed using Wald-type test along with the incidence rate ratio of the comparison.||1.1848|0.6264|0.2944
72608223|NCT01764841|144744919|SUPERIORITY_OR_OTHER||Incidence Rate Ratio|0.7329||||0.0382|TWO_SIDED|97.5|0.5237|1.0256|||Poisson regression|||A Poisson regression with adjustment for over-/under dispersion was used to analyze the number of exacerbation events over 48 weeks and to test the difference in the frequency of exacerbation between Ciprofloxacin DPI 14 and Pooled placebo group. P-value was analyzed using Wald-type test along with the incidence rate ratio of the comparison.||1.0256|0.5237|0.0382
72608224|NCT01103323|144744930|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.774||||0.005178||95.0|0.636|0.942||According to protocol specified O'Brien-Fleming type alpha spending function and 432 death events at 2nd IA, the pre-specified alpha (false positive rate) for this analysis was 0.009279 (1-sided).|Log Rank||Two treatment groups compared using a stratified log-rank test, stratified by same stratification factors as randomization. Hazard ratio (Regorafenib / Placebo) and its 95% confidence interval calculated using Cox model, stratified by same factors.|Sample size based on primary efficacy endpoint of OS. The study was designed to have 90% power to detect 33.3% increase in median OS (i.e. hazard ratio of 0.75, Regorafenib / Placebo). Assuming 1-sided overall alpha of 0.025, randomization ratio of 2:1 for Regorafenib and Placebo, and 2 formal interim analyses of OS using an O'Brien-Fleming-type error spending function, a total of 582 death events were required for primary completion. Results based on 2nd planned formal IA with 432 total events.||0.942|0.636|0.005178
72608225|NCT01103323|144744931|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.494|||<|1e-06||95.0|0.419|0.582||Comparison based on pre-specified alpha level of 0.025 (1-sided).|Log Rank||Hazard ratio (Regorafenib / Placebo)|Two treatment groups compared using a stratified log-rank test, stratified by same stratification factors as randomization. Hazard ratio (Regorafenib / Placebo) and its 95% confidence interval calculated using Cox model, stratified by same factors.||0.582|0.419|<0.000001
72608226|NCT01103323|144744932|SUPERIORITY_OR_OTHER||Difference|-0.6||||0.188432||95.0|-1.74|0.53||Comparison based on pre-specified alpha level of 0.025 (1-sided).|Cochran-Mantel-Haenszel||Difference = Placebo - Regorafenib 160 mg|Two treatment groups compared using Cochran-Mantel-Haenszel (CMH) test adjusting for same stratification factors as at randomization.||0.53|-1.74|0.188432
72608227|NCT01103323|144744933|SUPERIORITY_OR_OTHER||Difference|-25.94|||<|1e-06||95.0|-32.06|-19.82||Comparison based on pre-specified alpha level of 0.025 (1-sided).|Cochran-Mantel-Haenszel||Difference = Placebo - Regorafenib 160 mg|Two treatment groups compared using Cochran-Mantel-Haenszel (CMH) test adjusting for same stratification factors as at randomization.||-19.82|-32.06|<0.000001
72325371|NCT01247064|144174080|SUPERIORITY_OR_OTHER|||||||0.36|||||||t-test, 2 sided|||||||0.36
72325372|NCT01247064|144174081|SUPERIORITY_OR_OTHER|||||||0.62|||||||Chi-squared|||||||0.62
72325373|NCT04828707|144174082|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|||"The Intent-To-Treat (ITT) dataset was used for primary outcome. To overcome impact of missing data, statistical analysis was conducted using the Last Observation Carried Forward (LOCF) as an imputation method.~The data of each variable collected from the daily diary was normalized to 28 days for every period (weeks 1-4, weeks 5-8, and weeks 9-12).~Participants' data who entered the treatment phase but dropped out during weeks 5-8 were carried forward and analyzed as their data at weeks 9-12."||||<0.05
72325374|NCT00523978|144174108|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Fisher Exact|||The null hypothesis is the success rate in experimental group is less than and equal to the one in control group. This comparison of the rates was performed using a 2-sided Fisher's Exact. A sample size of 240(160 experimental and 80 control) is required to provide 80% power to detect the treatment difference using a 2-sided (alpha = 0.05)Fisher's Exact Test of binomial proportions assuming the success rate was 40% for control and 60% for treatment.||||<0.0001
72417054|NCT04794803|144344928|SUPERIORITY|||||||1||||||p-values are referred to a two-sided Fisher's Exact test for proportion|Fisher Exact|||EOS||||1.000
72417055|NCT04794803|144344929|SUPERIORITY|||||||0.696||||||p-values are referred to a two-sided Wilcoxon test for cumulative duration|Wilcoxon (Mann-Whitney)|||Week 1||||0.696
72417056|NCT04794803|144344929|SUPERIORITY||||||>|0.999||||||p-values are referred to a-sided Wilcoxon test for cumulative duration|Wilcoxon (Mann-Whitney)|||EOT||||>0.999
72417057|NCT04794803|144344929|SUPERIORITY|||||||0.596||||||p-values are referred to a-sided Wilcoxon test for cumulative duration|Wilcoxon (Mann-Whitney)|||EOS||||0.596
72417058|NCT04794803|144344930|SUPERIORITY|||||||1||||||p-values are referred to a two-sided Fisher's Exact test for proportion|Fisher Exact|||Baseline||||1.000
72417059|NCT04794803|144344930|SUPERIORITY|||||||1|||||||Fisher Exact|p-values are referred to a two-sided Fisher's Exact test for proportion||Day 1||||1.000
72417060|NCT04794803|144344930|SUPERIORITY|||||||1|||||||Fisher Exact|p-values are referred to a two-sided Fisher's Exact test for proportion||Day 2||||1.000
72417061|NCT04794803|144344930|SUPERIORITY|||||||1|||||||Fisher Exact|p-values are referred to a two-sided Fisher's Exact test for proportion||week 1||||1.000
72417062|NCT04794803|144344930|SUPERIORITY|||||||1||||||p-values are referred to a two-sided Fisher's Exact test for proportion|Fisher Exact|||EOT||||1.000
72417063|NCT04794803|144344932|SUPERIORITY|||||||0.76||||||p-values are referred to a two-sided Wilcoxon test|Wilcoxon (Mann-Whitney)|||baseline||||0.760
72417064|NCT04794803|144344932|SUPERIORITY|||||||0.394||||||p-values are referred to a two-sided Wilcoxon test|Wilcoxon (Mann-Whitney)|||Week 1||||0.394
72417065|NCT04794803|144344932|SUPERIORITY|||||||0.141||||||p-values are referred to a two-sided Wilcoxon test|Wilcoxon (Mann-Whitney)|||EOT||||0.141
72417066|NCT04794803|144344932|SUPERIORITY||||||>|0.999||||||p-values are referred to a two-sided Wilcoxon test|Wilcoxon (Mann-Whitney)|||EOS||||>0.999
72417067|NCT04794803|144344933|SUPERIORITY|||||||0.5||||||p-values are referred to a two-sided Wilcoxon test.|Wilcoxon (Mann-Whitney)|||baseline||||0.500
72417068|NCT04794803|144344933|SUPERIORITY|||||||0.112||||||p-values are referred to a two-sided Wilcoxon test.|Wilcoxon (Mann-Whitney)|||week 1||||0.112
72417069|NCT04794803|144344933|SUPERIORITY|||||||0.277||||||p-values are referred to a two-sided Wilcoxon test.|Wilcoxon (Mann-Whitney)|||EOT||||0.277
72417070|NCT04794803|144344933|SUPERIORITY||||||>|0.999||||||p-values are referred to a two-sided Wilcoxon test.|Wilcoxon (Mann-Whitney)|||EOS||||>0.999
72417071|NCT04794803|144344934|SUPERIORITY|||||||0.2027||||||p-values are referred to a two-sided Wilcoxon test for differences in the change|Wilcoxon (Mann-Whitney)|||Day 1 vs baseline||||0.2027
72417072|NCT04794803|144344934|SUPERIORITY|||||||1||||||p-values are referred to a two-sided Wilcoxon test for differences in the change|Wilcoxon (Mann-Whitney)|||Day 2 vs baseline||||1.0000
72417073|NCT04794803|144344934|SUPERIORITY|||||||0.4469||||||p-values are referred to a two-sided Wilcoxon test for differences in the change|Wilcoxon (Mann-Whitney)|||Week 1 vs baseline||||0.4469
72417074|NCT04794803|144344934|SUPERIORITY|||||||0.2466||||||p-values are referred to a two-sided Wilcoxon test for differences in the change|Wilcoxon (Mann-Whitney)|||EOT vs baseline||||0.2466
72417075|NCT04794803|144344934|SUPERIORITY|||||||0.1752||||||p-values are referred to a two-sided Wilcoxon test for differences in the change|Wilcoxon (Mann-Whitney)|||EOS vs baseline||||0.1752
72417076|NCT04794803|144344935|SUPERIORITY|||||||0.6441||||||p-values are referred to a two-sided Wilcoxon test for differences in the change.|Wilcoxon (Mann-Whitney)|||Day 1 vs baseline||||0.6441
72417077|NCT04794803|144344935|SUPERIORITY|||||||0.3529||||||p-values are referred to a two-sided Wilcoxon test for differences in the change.|Wilcoxon (Mann-Whitney)|||Day 2 vs baseline||||0.3529
72417078|NCT04794803|144344935|SUPERIORITY|||||||0.3581||||||p-values are referred to a two-sided Wilcoxon test for differences in the change.|Wilcoxon (Mann-Whitney)|||week 1 vs baseline||||0.3581
72417079|NCT04794803|144344935|SUPERIORITY|||||||0.1666||||||p-values are referred to a two-sided Wilcoxon test for differences in the change.|Wilcoxon (Mann-Whitney)|||EOT vs baseline||||0.1666
72417080|NCT04794803|144344935|SUPERIORITY|||||||0.0851||||||p-values are referred to a two-sided Wilcoxon test for differences in the change.|Wilcoxon (Mann-Whitney)|||EOS vs baseline||||0.0851
72417081|NCT04794803|144344936|SUPERIORITY|||||||0.3359||||||p-values are referred to a two-sided Wilcoxon test for differences in the change|Wilcoxon (Mann-Whitney)|||Day 1 vs baseline||||0.3359
72417082|NCT04794803|144344936|SUPERIORITY|||||||0.3136||||||p-values are referred to a two-sided Wilcoxon test for differences in the change|Wilcoxon (Mann-Whitney)|||Day 2 vs baseline||||0.3136
72417083|NCT04794803|144344936|SUPERIORITY|||||||0.0441||||||p-values are referred to a two-sided Wilcoxon test for differences in the change|Wilcoxon (Mann-Whitney)|||week 1 vs baseline||||0.0441
72417084|NCT04794803|144344936|SUPERIORITY|||||||0.0965||||||p-values are referred to a two-sided Wilcoxon test for differences in the change|Wilcoxon (Mann-Whitney)|||EOT vs baseline||||0.0965
72417085|NCT04794803|144344936|SUPERIORITY|||||||0.0519||||||p-values are referred to a two-sided Wilcoxon test for differences in the change|Wilcoxon (Mann-Whitney)|||EOS vs baseline||||0.0519
72417086|NCT04794803|144344937|SUPERIORITY|||||||0.47||||||p-values are referred to a two-sided Wilcoxon test for differences in the change.|Wilcoxon (Mann-Whitney)|||Day 1 vs baseline||||0.470
72417087|NCT04794803|144344937|SUPERIORITY|||||||0.425||||||p-values are referred to a two-sided Wilcoxon test for differences in the change.|Wilcoxon (Mann-Whitney)|||Day 2 vs baseline||||0.425
72417088|NCT04794803|144344937|SUPERIORITY|||||||0.086||||||p-values are referred to a two-sided Wilcoxon test for differences in the change.|Wilcoxon (Mann-Whitney)|||week 1 vs baseline||||0.086
72417089|NCT04794803|144344937|SUPERIORITY|||||||0.6||||||p-values are referred to a two-sided Wilcoxon test for differences in the change.|Wilcoxon (Mann-Whitney)|||EOT vs baseline||||0.600
72417090|NCT04794803|144344937|SUPERIORITY|||||||0.717||||||p-values are referred to a two-sided Wilcoxon test for differences in the change.|Wilcoxon (Mann-Whitney)|||EOS vs baseline||||0.717
72417091|NCT01570829|144344990|SUPERIORITY|||||||0.0352|||||||Fisher Exact|||||||0.0352
72417092|NCT01570829|144344991|SUPERIORITY|||||||0.0001|||||||Wilcoxon (Mann-Whitney)|||||||0.0001
72417093|NCT01570829|144344992|SUPERIORITY|||||||0.0001|||||||Wilcoxon (Mann-Whitney)|||||||0.0001
72417094|NCT01570829|144344993|SUPERIORITY|||||||0.0001|||||||Cochran-Mantel-Haenszel|Breslow-Day test p-value is 0.98||||||0.0001
72417095|NCT01570829|144344994|SUPERIORITY|||||||0.0004||||||"The p-value associated with treatment\*visit interaction of changes from baseline to Week 4, 8, 12, 16 and 20 endpoint between Dietressa and Placebo treatment groups. Model includes treatment, visit and treatment\*visit interaction."|ANOVA|||||||0.0004
72417096|NCT01570829|144344995|SUPERIORITY|||||||0.0004||||||"The p-value associated with treatment\*visit interaction of changes from baseline to Week 4, 8, 12, 16 and 20 endpoint between Dietressa and Placebo treatment groups. Model includes treatment, visit and treatment\*visit interaction."|ANOVA|||||||0.0004
72417097|NCT01570829|144344996|SUPERIORITY|||||||0.67||||||"The p-value associated with treatment\*visit interaction of changes from baseline to Week 4, 12, and 24 endpoint between Dietressa and Placebo treatment groups. Model includes treatment, visit and treatment\*visit interaction."|ANOVA|||This analysis applies to rows with waist circumference data.||||0.67
72417098|NCT01570829|144344996|SUPERIORITY|||||||0.26||||||"The p-value associated with treatment\*visit interaction of changes from baseline to Week 4, 12, and 24 endpoint between Dietressa and Placebo treatment groups. Model includes treatment, visit and treatment\*visit interaction."|ANOVA|||This analysis applies to rows with hip circumference data.||||0.26
72608228|NCT04794751|144744960|NON_INFERIORITY|Non-Inferiority was declared if the upper limit of the 95% confidence interval of the LSM difference between the Test and Control was below 0.05 logMAR.|least-square mean difference|-0.018|STANDARD_ERROR_OF_MEAN|0.0106|||TWO_SIDED|95.0|-0.039|0.002|||Linear Mixed Model|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.|LS Mean difference was calculated as Test minus Control|Distance (4m)||0.002|-0.039|
72608229|NCT04794751|144744960|NON_INFERIORITY|Non-inferiority was declared if the upper limit of the 95% confidence interval of the LSM difference between the Test and Control was below 0.05 logMAR.|least-square mean difference|-0.007|STANDARD_ERROR_OF_MEAN|0.0127|||TWO_SIDED|95.0|-0.032|0.018|||Linear Mixed Model|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.|LS Mean difference was calculated as Test minus Control|Intermediate (64cm)||0.018|-0.032|
72608230|NCT04794751|144744960|NON_INFERIORITY|Non-inferiority was declared if the upper limit of the 95% confidence interval of the LSM difference between the Test and Control was below 0.05 logMAR.|least-square mean difference|-0.01|STANDARD_ERROR_OF_MEAN|0.0124|||TWO_SIDED|95.0|-0.034|0.015|||Linear Mixed Model|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.|LS Mean difference was calculated as Test minus Control|Near (40cm)||0.015|-0.034|
72608231|NCT04794751|144744961|NON_INFERIORITY|Non-inferiority was declared if the lower limit of the 95% confidence interval for the least-square mean difference was greater than -5.|least-square mean difference|0.1|STANDARD_ERROR_OF_MEAN|2.34|||TWO_SIDED|95.0|-4.6|4.8|||Linear Mixed Model|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.|LS Mean difference was calculated as Test minus Control|||4.8|-4.6|
72608232|NCT01939314|144744988|SUPERIORITY_OR_OTHER||Risk Difference (RD)|7.5|||||TWO_SIDED|95.0|-13.0|27.1||||||||27.1|-13.0|
72608233|NCT01939314|144744990|SUPERIORITY_OR_OTHER||Risk Difference (RD)|24.7|||||TWO_SIDED|95.0|2.6|43.6||||||||43.6|2.6|
72608234|NCT02563899|144745024|SUPERIORITY_OR_OTHER||Percent difference in treatment|-1.0|||||TWO_SIDED|95.0|-42.2|39.9||||||Umeclidinium, 2 mg/cm\^2 of 1.85%, OD Vs Vehicle: \<=-30%||39.9|-42.2|
72608235|NCT02563899|144745024|SUPERIORITY_OR_OTHER||Percent difference in treatment|1.0|||||TWO_SIDED|95.0|-39.9|42.2||||||Umeclidinium, 2 mg/cm\^2 of 1.85%, OD vs Vehicle: \<=-50%||42.2|-39.9|
72417099|NCT01570829|144344997|SUPERIORITY|||||||0.4||||||"The p-value associated with treatment\*visit interaction of changes from baseline to Week 4, 12, and 24 endpoint between Dietressa and Placebo treatment groups. Model includes treatment, visit and treatment\*visit interaction."|ANOVA|||This analysis applies to rows with Physical Health domain data.||||0.40
72417100|NCT01570829|144344997|SUPERIORITY|||||||0.34||||||"The p-value associated with treatment\*visit interaction of changes from baseline to Week 4, 12, and 24 endpoint between Dietressa and Placebo treatment groups. Model includes treatment, visit and treatment\*visit interaction."|ANOVA|||This analysis applies to rows with Mental Health domain data.||||0.34
72417101|NCT03364751|144344998|OTHER||LS Mean Difference|0.068||||0.297|TWO_SIDED|95.0|-0.06|0.196|||Mixed Models Analysis|||Month 6: Difference between Cigarette and IQOS||0.196|-0.060|0.297
72417102|NCT03364751|144344998|OTHER||LS Mean Difference|-0.064||||0.55|TWO_SIDED|95.0|-0.273|0.146|||Mixed Models Analysis|||Month 6: Difference between Cigarette and Dual Use||0.146|-0.273|0.550
72417103|NCT03364751|144344999|OTHER||LS Mean Difference|0.043||||0.502|TWO_SIDED|95.0|-0.084|0.171|||Mixed Models Analysis|||Month 3: Difference between Cigarette and IQOS||0.171|-0.084|0.502
72417104|NCT03364751|144344999|OTHER||LS Mean Difference|-0.02||||0.851|TWO_SIDED|95.0|-0.229|0.189|||Mixed Models Analysis|||Month 3: Difference between Cigarette and Dual Use||0.189|-0.229|0.851
72417105|NCT03364751|144345000|OTHER||LS Mean Difference|0.07||||0.376|TWO_SIDED|95.0|-0.085|0.224|||Mixed Models Analysis|||Month 3: Difference between Cigarette and IQOS||0.224|-0.085|0.376
72417106|NCT03364751|144345000|OTHER||LS Mean Difference|0.025||||0.848|TWO_SIDED|95.0|-0.229|0.279|||Mixed Models Analysis|||Month 3: Difference between Cigarette and DualUse||0.279|-0.229|0.848
72608236|NCT02563899|144745024|SUPERIORITY_OR_OTHER||Percent difference in treatment|9.0|||||TWO_SIDED|95.0|-25.2|44.0||||||Umeclidinium, 2 mg/cm\^2 of 1.85%, OD Vs Vehicle: \<=-70%||44.0|-25.2|
72608237|NCT02563899|144745026|SUPERIORITY_OR_OTHER||Percent difference in treatment|27.0|||||TWO_SIDED|95.0|-8.5|62.6||||||||62.6|-8.5|
72608238|NCT00794664|144745027|SUPERIORITY_OR_OTHER||||||<|0.001||||||Statistical significance was concluded if p≤0.05|t-test, 2 sided|||Based upon prior clinical study experience with mipomersen, it was estimated that the standard deviation of the percent change in LDL-C was approximately 22%. With 15 patients in the control group and 30 patients in the mipomersen-treated group, this study would have at least 80% power to detect a 20 percentage point difference between the 2 treatment groups. Enrollment was to be conducted such that at least 51 patients were randomized to allow for potential exclusions from an analysis set.||||<0.001
72608239|NCT00794664|144745029|SUPERIORITY_OR_OTHER||||||<|0.001||||||Inflation of type 1 error was controlled by specifying a small number of secondary parameters and a sequential inferential approach in which inferential conclusions about each successive parameter required statistical significance of the prior one.|t-test, 2 sided|||||||<0.001
72608240|NCT00794664|144745031|SUPERIORITY_OR_OTHER||||||<|0.001||||||Inferential conclusions about this parameter require statistical significance of the previous secondary outcome measure (i.e., percent change from baseline in Apo B at PET).|t-test, 2 sided|||||||<0.001
72608241|NCT00794664|144745033|SUPERIORITY_OR_OTHER||||||<|0.001||||||Inferential conclusions about this parameter require statistical significance of the previous secondary outcome measure (i.e., percent change from baseline in total cholesterol at PET).|t-test, 2 sided|||||||<0.001
72608242|NCT00794664|144745035|SUPERIORITY_OR_OTHER|||||||0.034||||||Statistical significance was concluded if p ≤0.05|t-test, 2 sided|||||||0.034
72608243|NCT00794664|144745037|SUPERIORITY_OR_OTHER||||||<|0.001||||||Statistical significance was concluded if p ≤0.05|t-test, 2 sided|||||||<0.001
72608244|NCT00794664|144745039|SUPERIORITY_OR_OTHER||||||<|0.032||||||Statistical significance was concluded if p ≤0.05|t-test, 2 sided|||||||<0.032
72608245|NCT00794664|144745041|SUPERIORITY_OR_OTHER||||||<|0.001||||||Statistical significance was concluded if p ≤0.05|Wilcoxon rank sum test|||||||<0.001
72608246|NCT00794664|144745043|SUPERIORITY_OR_OTHER|||||||0.278||||||Statistical significance was concluded if p ≤0.05|t-test, 2 sided|||||||0.278
72608247|NCT00794664|144745045|SUPERIORITY_OR_OTHER|||||||0.647||||||Statistical significance was concluded if p ≤0.05|t-test, 2 sided|||||||0.647
72608248|NCT01062308|144745047|SUPERIORITY_OR_OTHER||Mean difference from baseline to day 30|-11.8||||0.03|TWO_SIDED|95.0|-22.6|-1.1|||Mixed Models Analysis|||||-1.1|-22.6|0.03
72608249|NCT01062308|144745048|SUPERIORITY_OR_OTHER||Mean difference from baseline to day 30|6.6||||0.16|TWO_SIDED|95.0|-2.7|15.9|||Mixed Models Analysis|||||15.9|-2.7|0.16
72608250|NCT00457730|144745061|SUPERIORITY_OR_OTHER|||||||0.016|TWO_SIDED||||||t-test, 2 sided|||||||0.016
72608251|NCT00457730|144745062|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED||||||t-test, 2 sided|||||||0.002
72608252|NCT00457730|144745063|SUPERIORITY_OR_OTHER|||||||0.074|TWO_SIDED||||||t-test, 2 sided|||||||0.074
72608253|NCT00496769|144745065|SUPERIORITY||Hazard Ratio (HR)|0.45|||<|1e-05|TWO_SIDED|95.0|0.32|0.62|||Log Rank|||||0.62|0.32|<0.00001
72608254|NCT00496769|144745066|SUPERIORITY||Hazard Ratio (HR)|0.66||||0.00026|TWO_SIDED|95.0|0.53|0.83|||Log Rank||Vascular death|||0.83|0.53|0.00026
72608255|NCT00496769|144745067|SUPERIORITY||Hazard Ratio (HR)|0.79||||0.06782|TWO_SIDED|95.0|0.62|1.02|||Log Rank||All-cause death|||1.02|0.62|0.06782
72608256|NCT00496769|144745067|SUPERIORITY||Hazard Ratio (HR)|0.73||||0.0028|TWO_SIDED|95.0|0.6|0.9|||Log Rank||Composite endpoint of major vascular events and major bleeding-net clinical benefit|||0.90|0.60|0.00280
72608257|NCT00496769|144745067|SUPERIORITY||Hazard Ratio (HR)|0.87||||0.36586|TWO_SIDED|95.0|0.65|1.17|||Log Rank||Vascular death|||1.17|0.65|0.36586
72608258|NCT00496769|144745068|OTHER||Hazard Ratio (HR)|1.54||||0.0716|TWO_SIDED|95.0|0.96|2.45|||Log Rank||Major bleeding|||2.45|0.96|0.0716
72608259|NCT00496769|144745068|OTHER||Hazard Ratio (HR)|1.3||||0.0017|TWO_SIDED|95.0|1.1|1.53|||Log Rank||All bleeding|||1.53|1.10|0.0017
72608260|NCT00496769|144745068|OTHER||Hazard Ratio (HR)|1.38||||0.0144|TWO_SIDED|95.0|1.07|1.78|||Log Rank||Major or CNRM bleeding|||1.78|1.07|0.0144
72608261|NCT00496769|144745069|OTHER||Hazard Ratio (HR)|1.3||||0.0017|TWO_SIDED|95.0|1.1|1.53|||Log Rank|||||1.53|1.10|0.0017
72608262|NCT02812186|144745074|SUPERIORITY|||||||0.01|||||||Wilcoxon (Mann-Whitney)|||||||0.01
72608263|NCT02812186|144745075|SUPERIORITY|||||||0.28|||||||Wilcoxon (Mann-Whitney)|||||||0.28
72417107|NCT03364751|144345000|OTHER||LS Mean Difference|0.092||||0.246|TWO_SIDED|95.0|-0.064|0.247|||Mixed Models Analysis|||Month 6: Difference between Cigarette and IQOS||0.247|-0.064|0.246
72325375|NCT00523978|144174109|NON_INFERIORITY_OR_EQUIVALENCE|A non-inferiority margin was selected based on literature review.|||||<|0.001|||||||t-test, 1 sided|||The null hypothesis is the proportion of subjects free from MAFE in the experimental group is inferior to that in the control group using 10% non-inferiority margin.A sample size of 160 evaluable cryoablation and 80 control subjects (one-sided α = 0.05, 2:1 randomization) was required to provide 80% power assuming the rate of free from MAFE at 12 months 80.5 and 77% in experimental and control groups respectively .||||<0.001
72608264|NCT02812186|144745076|SUPERIORITY|||||||0.63|||||||Wilcoxon (Mann-Whitney)|||||||0.63
72608265|NCT01573000|144745086|SUPERIORITY_OR_OTHER||percentage of participants|50.0|||||TWO_SIDED|95.0|35.0|65.0|||||The estimated value represents the percentage of participants with confirmed response (CR, CCR, PR). The number of participants evaluable for overall response (confirmed and unconfirmed; n=42) is used as the denominator.|||65|35|
72325376|NCT00523978|144174110|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Fisher Exact|||The test hypothesis is UCBExperimental\_CPE ≥ 14.8% vs UCBExperimental\_CPE \< 14.8%.The performance goal 14.8% was chosen based on a review of SSEDs for similar types of ablation trials.The expected rate for CPEs in a well-monitored trial of left atrial RF ablation for AF was estimated to be 10% (corresponding to a CPE-free rate of 90%).In a trial with 160 subject, the resulting one-sided 95% upper confidence bound would be 14.8%.||||<0.001
72417108|NCT03364751|144345000|OTHER||LS Mean Difference|-0.105||||0.417|TWO_SIDED|95.0|-0.359|0.15|||Mixed Models Analysis|||Month 6: Difference between Cigarette and Dual Use||0.150|-0.359|0.417
72608266|NCT01573000|144745086|SUPERIORITY_OR_OTHER||percentage of participants|22.0|||||TWO_SIDED|95.0|9.0|36.0|||||The estimated value represents the percentage of participants with confirmed response (CR, CCR, PR). The number of participants evaluable for overall response (confirmed and unconfirmed; n=36) is used as the denominator.|||36|9|
72608267|NCT01573000|144745087|SUPERIORITY_OR_OTHER||percentage of participants|16.0|||||TWO_SIDED|95.0|0.0|32.0|||||The estimated value represents the percentage of participants with confirmed response (CR, CCR, PR) before Crossover.|||32|0|
72608268|NCT01573000|144745087|SUPERIORITY_OR_OTHER||percentage of participants|79.0|||||TWO_SIDED|95.0|61.0|97.0|||||The estimated value represents the percentage of participants with confirmed response (CR, CCR, PR) after Crossover.|||97|61|
72608269|NCT01573000|144745088|SUPERIORITY_OR_OTHER||percentage of participants|26.0|||||TWO_SIDED|95.0|13.0|39.0|||||The estimated value represents the percentage of participants with complete response. The number of participants evaluable for overall response (confirmed and unconfirmed; n=42) is used as the denominator.|||39|13|
72608270|NCT01573000|144745088|SUPERIORITY_OR_OTHER||percentage of participants|8.0|||||TWO_SIDED|95.0|0.0|17.0|||||The estimated value represents the percentage of participants with complete response. The number of participants evaluable for overall response (confirmed and unconfirmed; n=36) is used as the denominator.|||17|0|
72608271|NCT01573000|144745089|SUPERIORITY_OR_OTHER|||||||0.012||95.0|||||Fisher Exact|||||||0.012
72608272|NCT01573000|144745090|SUPERIORITY_OR_OTHER||percentage of participants|0.0|||||TWO_SIDED|95.0|0.0|0.0|||||The estimated value represents the percentage of participants with confirmed complete response before Crossover.|||0|0|
72608273|NCT01573000|144745090|SUPERIORITY_OR_OTHER||percentage of participants|42.0|||||TWO_SIDED|95.0|20.0|64.0|||||The estimated value represents the percentage of participants with confirmed complete response after Crossover.|||64|20|
72608274|NCT01573000|144745091|SUPERIORITY_OR_OTHER||percentage of participants|2.0|||||TWO_SIDED|95.0|0.0|7.0|||||The estimated value represents the percentage of participants with confirmed CCR. The number of participants evaluable for overall response (confirmed and unconfirmed; n=42) is used as the denominator.|||7|0|
72417109|NCT00675766|144345016|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED||||||Repeated Measures ANOVA|Range of z-scores at baseline: -1.69 to 1.38. Range of z-scores at Year 1 follow-up: -1.28 to 1.36.||Repeated Measures ANOVA with overall neurocognitive performance at baseline and follow-up, computed as z-scored derived composite score of 14 individual neuropsychological measures assessing attention, processing speed, visuospatial skills, language, memory, executive function and motor skills, across time as the within-group factor and HIV serostatus and age group as between-group factors.||||0.001
72417110|NCT00675766|144345016|SUPERIORITY_OR_OTHER||||||<|0.005|TWO_SIDED||||||Repeated Measures ANOVA|Range of z-scores at baseline: -2.96 to 1.89. Range of z-scores at Year 1 follow-up: -1.89 to 1.77.||Repeated Measures ANOVA with processing speed at baseline and follow-up, computed as z-scored derived composite score of multiple neuropsychological measures assessing speed of cognitive information processing, across time as the within-group factor and HIV serostatus and age group as between-group factors.||||<0.005
72608275|NCT01573000|144745091|SUPERIORITY_OR_OTHER||percentage of participants|3.0|||||TWO_SIDED|95.0|0.0|8.0|||||The estimated value represents the percentage of participants with confirmed CCR. The number of participants evaluable for overall response (confirmed and unconfirmed; n=36) is used as the denominator.|||8|0|
72608276|NCT01573000|144745092|SUPERIORITY_OR_OTHER||percentage of participants|0.0|||||TWO_SIDED|95.0|0.0|0.0|||||The estimated value represents the percentage of participants with confirmed CCR before Crossover.|||0|0|
72417111|NCT00675766|144345016|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||Repeated Measures ANOVA|Range of z-scores at baseline: -2.30 to 2.44. Range of z-scores at Year 1 follow-up: -1.82 to 2.00.||Repeated Measures ANOVA with attention at baseline and follow-up, computed as z-scored derived composite score of multiple neuropsychological measures assessing attentional abilities, across time as the within-group factor and HIV serostatus and age group as between-group factors.||||< 0.01
72417112|NCT00675766|144345016|SUPERIORITY_OR_OTHER||||||<|0.07|TWO_SIDED||||||Repeated Measures ANOVA|Range of z-scores at baseline: -1.76 to 0.95. Range of z-scores at Year 1 follow-up: -1.18 to 0.84.||Repeated Measures ANOVA with executive function at baseline and follow-up, computed as z-scored derived composite score of multiple neuropsychological measures assessing working memory, set shifting, mental flexibility and problem solving, across time as the within-group factor and HIV serostatus and age group as between-group factors.||||<0.07
72608277|NCT01573000|144745092|SUPERIORITY_OR_OTHER||percentage of participants|5.0|||||TWO_SIDED|95.0|0.0|15.0|||||The estimated value represents the percentage of participants with confirmed CCR after Crossover.|||15|0|
72608278|NCT01573000|144745093|SUPERIORITY_OR_OTHER||percentage of participants|31.0|||||TWO_SIDED|95.0|17.0|45.0|||||The estimated value represents the percentage of participants with confirmed CR and CCR. The number of participants evaluable for overall response (confirmed and unconfirmed; n=42) is used as the denominator.|||45|17|
72608279|NCT01573000|144745093|SUPERIORITY_OR_OTHER||percentage of participants|11.0|||||TWO_SIDED|95.0|1.0|21.0|||||The estimated value represents the percentage of participants with confirmed CR and CCR. The number of participants evaluable for overall response (confirmed and unconfirmed; n=36) is used as the denominator.|||21|1|
72608280|NCT01573000|144745094|SUPERIORITY_OR_OTHER||percentage of participants|0.0|||||TWO_SIDED|95.0|0.0|0.0|||||The estimated value represents the percentage of participants with confirmed CR and CCR before Crossover.|||0|0|
72608281|NCT01573000|144745094|SUPERIORITY_OR_OTHER||percentage of participants|47.0|||||TWO_SIDED|95.0|25.0|70.0|||||The estimated value represents the percentage of participants with confirmed CR and CCR after Crossover.|||70|25|
72608282|NCT01573000|144745095|SUPERIORITY_OR_OTHER||percentage of participants|17.0|||||TWO_SIDED|95.0|5.0|28.0|||||The estimated value represents the percentage of participants with confirmed PR. The number of participants evaluable for overall response (confirmed and unconfirmed; n=42) is used as the denominator.|||28|5|
72608283|NCT01573000|144745095|SUPERIORITY_OR_OTHER||percentage of participants|11.0|||||TWO_SIDED|95.0|1.0|21.0|||||The estimated value represents the percentage of participants with confirmed PR. The number of participants evaluable for overall response (confirmed and unconfirmed; n=36) is used as the denominator.|||21|1|
72608284|NCT01573000|144745096|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||Fisher Exact|||||||0.001
72608285|NCT01573000|144745098|SUPERIORITY_OR_OTHER|||||||0.495||95.0|||||Log Rank|||||||0.495
72608286|NCT01573000|144745099|SUPERIORITY_OR_OTHER|||||||0.677||95.0|||||Log Rank|||||||0.677
72608287|NCT01573000|144745102|SUPERIORITY_OR_OTHER|||||||0.119||95.0|||||Log Rank|||||||0.119
72608288|NCT01573000|144745103|SUPERIORITY_OR_OTHER|||||||0.016||95.0|||||Log Rank|||||||0.016
72608289|NCT01573000|144745116|SUPERIORITY_OR_OTHER||percentage of participants|16.0|||||TWO_SIDED|95.0|0.0|32.0|||||The estimated value represents the percentage of participants with confirmed PR before Crossover.|||32|0|
72608290|NCT01573000|144745116|SUPERIORITY_OR_OTHER||percentage of participants|32.0|||||TWO_SIDED|95.0|11.0|52.0|||||The estimated value represents the percentage of participants with confirmed PR after Crossover.|||52|11|
72608291|NCT01926028|144745161|EQUIVALENCE|The proportion of patients in each group was summarized with point estimates and their 95% confidence interval|Cox Proportional Hazard|0.39||||0.03|TWO_SIDED|95.0|0.17|0.91|||Wilcoxon (Mann-Whitney)|||||0.91|0.17|0.03
72608292|NCT01926028|144745162|EQUIVALENCE|The proportion of patients in each group was summarized with point estimates and their 95% confidence interval|Cox Proportional Hazard|0.55||||0.1|TWO_SIDED|95.0|0.27|1.13|||Wilcoxon (Mann-Whitney)|||||1.13|0.27|0.10
72608293|NCT01130272|144745171|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.457||||0.052|TWO_SIDED|95.0|0.994|6.077|||ANCOVA|||||6.077|0.994|0.052
72608294|NCT01130272|144745171|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.383||||0.041|TWO_SIDED|95.0|1.036|5.478|||ANCOVA|||||5.478|1.036|0.041
72608295|NCT01130272|144745171|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.079||||0.09|TWO_SIDED|95.0|0.893|4.842|||ANCOVA|||||4.842|0.893|0.090
72608296|NCT01130272|144745171|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.797||||0.015|TWO_SIDED|95.0|1.227|6.376|||ANCOVA|||||6.376|1.227|0.015
72608297|NCT01130272|144745172|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.719||||0.449|TWO_SIDED|95.0|0.306|1.689|||ANCOVA|||||1.689|0.306|0.449
72608298|NCT01130272|144745172|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.208||||0.583|TWO_SIDED|95.0|0.615|2.373|||ANCOVA|||||2.373|0.615|0.583
72608299|NCT01130272|144745172|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.014||||0.03|TWO_SIDED|95.0|1.069|3.795|||ANCOVA|||||3.795|1.069|0.030
72608300|NCT01130272|144745172|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.395||||0.326|TWO_SIDED|95.0|0.717|2.716|||ANCOVA|||||2.716|0.717|0.326
72608301|NCT00641056|144745186|NON_INFERIORITY_OR_EQUIVALENCE|Power: 205 patients per treatment group would provide approximately 92% power to detect a true difference between treatments of 0.4% in change in HbA1c from baseline with a 2-sided t test at a significance level of 0.05, assuming a common standard deviation of 1.2%.|Least Squares Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.07||0.017|TWO_SIDED|95.0|-0.29|-0.03||No adjustments for multiplicity were performed|Mixed Models Analysis|||Mixed-model Repeated Measures (MMRM) Analysis of Covariance (ANCOVA) model includes treatment, baseline HbA1c, country, background OAD stratum, week of visit, and treatment-by-week interaction as fixed effects; patient and error as random effects. Superiority of exenatide once weekly to insulin glargine is concluded if the upper limit of the 95% confidence interval for the treatment difference \[exenatide once weekly-insulin glargine\]\<0; noninferiority is concluded if this upper limit\<0.3%.||-0.03|-0.29|0.017
72608302|NCT00641056|144745187|SUPERIORITY_OR_OTHER|||||||0.097|TWO_SIDED|95.0||||No adjustments for multiplicity were performed|Cochran-Mantel-Haenszel|||Percentage of patients achieving HbA1c \<=7.0% at Week 26 were compared between treatments using a Cochran-Mantel-Haenszel (CMH) test, in which background OAD and country served as the stratification factors.||||0.097
72608303|NCT00641056|144745188|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED|95.0||||No adjustments for multiplicity were performed|Cochran-Mantel-Haenszel|||Percentage of patients achieving HbA1c \<=6.5% at Week 26 were compared between treatments using a CMH test, in which background OAD and country served as the stratification factors.||||0.002
72608304|NCT00641056|144745189|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.63|STANDARD_ERROR_OF_MEAN|0.19||0.001|TWO_SIDED|95.0|0.25|1.0||No adjustments for multiplicity were performed|Mixed Models Analysis|||MMRM ANCOVA with change in FSG as the dependent variable; treatment, baseline FSG, country, background OAD stratum, week of visit, and treatment-by-week interaction as fixed effects; patient and error as random effects.||1.00|0.25|0.001
72417113|NCT00675766|144345016|SUPERIORITY_OR_OTHER|||||||0.09|TWO_SIDED||||||Repeated Measures ANOVA|Range of z-scores at baseline: -2.30 to 1.94. Range of z-scores at Year 1 follow-up: -1.83 to 2.11.||Repeated Measures ANOVA with language at baseline and follow-up, computed as z-scored derived composite score of multiple neuropsychological measures assessing verbal fluency and naming skills, across time as the within-group factor and HIV serostatus and age group as between-group factors.||||0.09
72608305|NCT00641056|144745190|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-4.05|STANDARD_ERROR_OF_MEAN|0.27|<|0.001|TWO_SIDED|95.0|-4.57|-3.52||No adjustments for multiplicity were performed|Mixed Models Analysis|||MMRM ANCOVA with change in BW as the dependent variable; treatment, baseline BW, country, background OAD stratum, week of visit, and treatment-by-week interaction as fixed effects; patient and error as random effects.||-3.52|-4.57|<.001
72325377|NCT00696878|144174122|SUPERIORITY_OR_OTHER_LEGACY||Percentage with immunogenicity|0.0|||||ONE_SIDED|95.0||0.4|||||Provided limit is upper 1-sided 95% confidence limit for study population for percentage of participants with clinically relevant immunogenicity, after Cycle 1|During sample size determination, the upper limit of the one-sided 95% confidence interval for the population incidence of immunogenicity, if no immunogenicity is observed, was calculated. If no immunogenicity is observed in the projected 150 participants who receive corifollitropin alfa during 3 COS cycles, then the upper limit for the population is 2%. For the projected 300 participants who receive corifollitropin alfa during 2 COS cycles, the upper limit for the population is 1%.||0.4||
72325378|NCT00696878|144174122|SUPERIORITY_OR_OTHER_LEGACY||Percentage with immunogenicity|0.0|||||ONE_SIDED|95.0||0.8|||||Provided limit is upper 1-sided 95% confidence limit for study population for percentage of participants with clinically relevant immunogenicity, after Cycle 2|During sample size determination, the upper limit of the one-sided 95% confidence interval for the population incidence of immunogenicity, if no immunogenicity is observed, was calculated. If no immunogenicity is observed in the projected 150 participants who receive corifollitropin alfa during 3 COS cycles, then the upper limit for the population is 2%. For the projected 300 participants who receive corifollitropin alfa during 2 COS cycles, the upper limit for the population is 1%.||0.8||
72608306|NCT00641056|144745191|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.07||0.292|TWO_SIDED|95.0|-0.21|0.06||No adjustments for multiplicity were performed|Mixed Models Analysis|||MMRM ANCOVA with change in total cholesterol as the dependent variable; treatment, baseline total cholesterol, country, background OAD stratum, week of visit, and treatment-by-week interaction as fixed effects; patient and error as random effects.||0.06|-0.21|0.292
72608307|NCT00641056|144745192|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.02||0.377|TWO_SIDED|95.0|-0.05|0.02||No adjustments for multiplicity were performed|Mixed Models Analysis|||MMRM ANCOVA with change in HDL as the dependent variable; treatment, baseline HDL, country, background OAD stratum, week of visit, and treatment-by-week interaction as fixed effects; patient and error as random effects.||0.02|-0.05|0.377
72608308|NCT00641056|144745193|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean Ratio|1.07|STANDARD_ERROR_OF_MEAN|0.04||0.077|TWO_SIDED|95.0|0.99|1.15||No adjustments for multiplicity were performed|Mixed Models Analysis|||Triglycerides data were logarithm-transformed and the change at Week 26 to baseline, expressed as the ratio, was analyzed by MMRM ANCOVA with change in triglycerides as the dependent variable; treatment, baseline triglycerides, country, background OAD stratum, week of visit, and treatment-by-week interaction as fixed effects; patient and error as random effects.||1.15|0.99|0.077
72608309|NCT00737048|144745196|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.3|STANDARD_DEVIATION|8.06|<|0.0001|||||||Fisher Least Signiﬁcant Diﬀerence Method|||Statistical Analysis 1 for Total pain relief based on numerical rating scale score||||<0.0001
72608310|NCT00737048|144745196|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.3|STANDARD_DEVIATION|7.99|<|0.0001|||||||Fisher Least Signiﬁcant Diﬀerence Method|||Statistical Analysis 2 for Total pain relief based on numerical rating scale score||||<0.0001
72608311|NCT01774981|144745225|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0449|||||||t-test, 1 sided|||||||0.0449
72608312|NCT01774981|144745225|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0808|||||||t-test, 1 sided|||||||0.0808
72608313|NCT01774981|144745225|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2219|||||||t-test, 1 sided|||||||0.2219
72608314|NCT01324102|144745232|SUPERIORITY_OR_OTHER|||||||0.004|TWO_SIDED|95.0||||The a priori threshold for statistical significance is .05. The .004 value exceeds this value. There was only one comparison, so there was no adjustment for multiple comparison. This analysis refers to the row and category of anxiety.|ANOVA|F=10.25||Repeated measure Analysis of Variance (ANOVA) with null hypothesis of no group differences, comparing anxiety scores pre-Yoga versus post-Yoga, between the two groups for changes in anxiety.||||.004
72608315|NCT01324102|144745232|SUPERIORITY_OR_OTHER|||||||0.056|TWO_SIDED|||||F=4.07. The a priori threshold for statistical significance is .05. The .056 value does not exceed it. There was only one comparison, so there was no adjustment for multiple comparison. This analysis refers to the row/category of insomnia.|ANOVA|||Repeated measure Analysis of Variance (ANOVA) with null hypothesis of no group differences, comparing insomnia scores pre-Yoga versus post-Yoga, between the two groups. This measures changes in insomnia.||||.056
72608316|NCT00386334|144745241|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Multiple comparisons not applied due to only two treatments in the study.|ANCOVA|ANCOVA with treatment and site type as fixed effects and the baseline as a covariate||||||<0.0001
72608317|NCT00386334|144745244|SUPERIORITY_OR_OTHER|||||||0.0014||||||Multiple comparisons not applied due to only two treatments in the study.|ANCOVA|ANCOVA with treatment and site type as fixed effects and the baseline as a covariate||||||0.0014
72608318|NCT00386334|144745247|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Multiple comparisons not applied due to only two treatments in the study.|ANCOVA|ANCOVA with treatment and site type as fixed effects and the baseline as a covariate||||||<0.0001
72608319|NCT00386334|144745250|SUPERIORITY_OR_OTHER|||||||0.0005||||||Multiple comparisons not applied due to only two treatments in study.|ANCOVA|ANCOVA with treatment and site type as fixed effects and the baseline as a covariate||||||0.0005
72608320|NCT00386334|144745253|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Multiple comparisons not applied due to only two treatments in the study.|ANCOVA|ANCOVA with treatment and site type as fixed effects and the baseline as a covariate||||||<0.0001
72608321|NCT00386334|144745256|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Multiple comparisons not applied due to only two treatments in the study.|ANCOVA|ANCOVA with treatment and site type as fixed effects and the baseline as a covariate||||||<0.0001
72608322|NCT00386334|144745259|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Multiple comparisons not applied due to only two treatments in the study.|ANCOVA|ANCOVA with treatment and site type as fixed effects and the baseline as a covariate||||||<0.0001
72608323|NCT00386334|144745262|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Multiple comparisons not applied due to only two treatments in the study.|ANCOVA|ANCOVA with treatment and site type as fixed effects and the baseline as a covariate||||||<0.0001
72608324|NCT00386334|144745265|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Multiple comparisons not applied due to only two treatments in the study.|ANCOVA|ANCOVA with treatment and site type as fixed effects and the baseline as a covariate||||||<0.0001
72608325|NCT00386334|144745268|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Multiple comparisons not applied due to only two treatments in the study.|ANCOVA|ANCOVA with treatment and site type as fixed effects and the baseline as a covariate||||||<0.0001
72608326|NCT00386334|144745271|SUPERIORITY_OR_OTHER|||||||0.1175||||||Multiple comparisons not applied due to only two treatments in the study.|ANCOVA|ANCOVA with treatment and site type as fixed effects and the baseline as a covariate||||||0.1175
72608327|NCT00386334|144745274|SUPERIORITY_OR_OTHER|||||||0.0717||||||Multiple comparisons not applied due to only two treatments in the study.|ANCOVA|ANCOVA with treatment and site type as fixed effects and the baseline as a covariate||||||0.0717
72608328|NCT00386334|144745277|SUPERIORITY_OR_OTHER|||||||0.1182||||||Multiple comparisons not applied due to only two treatments in the study.|ANCOVA|||||||0.1182
72608329|NCT00386334|144745280|SUPERIORITY_OR_OTHER|||||||0.301||||||Multiple comparisons not applied due to only two treatments in the study.|ANCOVA|ANCOVA with treatment and site type as fixed effects and the baseline as a covariate||||||0.3010
72608330|NCT00386334|144745283|SUPERIORITY_OR_OTHER|||||||0.78||||||Multiple comparisons not applied due to only two treatments in the study.|ANCOVA|ANCOVA with treatment and site type as fixed effects and the baseline as a covariate||||||0.7800
72608331|NCT00386334|144745286|SUPERIORITY_OR_OTHER|||||||0.0803||||||Multiple comparisons not applied due to only two treatments in the study.|ANCOVA|ANCOVA with treatment and site type as fixed effects and the baseline as a covariate||||||0.0803
72608332|NCT00386334|144745289|SUPERIORITY_OR_OTHER|||||||0.2643||||||Multiple comparisons not applied due to only two treatments in the study.|ANCOVA|ANCOVA with treatment and site type as fixed effects and the baseline as a covariate||||||0.2643
72608333|NCT00386334|144745292|SUPERIORITY_OR_OTHER|||||||0.0765||||||Multiple comparisons not applied due to only two treatments in the study.|ANCOVA|ANCOVA with treatment and site type as fixed effects and the baseline as a covariate||||||0.0765
72608334|NCT00386334|144745295|SUPERIORITY_OR_OTHER|||||||0.2967||||||Multiple comparisons not applied due to only two treatments in the study.|ANCOVA|ANCOVA with treatment and site type as fixed effects and the baseline as a covariate||||||0.2967
72608335|NCT00386334|144745298|SUPERIORITY_OR_OTHER|||||||0.0634||||||Multiple comparisons not applied due to only two treatments in the study.|ANCOVA|ANCOVA with treatment and site type as fixed effects and the baseline as a covariate||||||0.0634
72608336|NCT00386334|144745301|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Multiple comparisons not applied due to only two treatments in the study.|ANCOVA|ANCOVA with treatment and site type as fixed effects and the baseline as a covariate||||||<0.0001
72608337|NCT03843372|144745310|SUPERIORITY||||||<|0.001|||||||Wilcoxon rank sum test|||The AHI was not a normal distribution. In the event that no carry over effect was detected between interventions, a Wilcoxon rank sum test was to be used to compare AHI between CPAP and HFNC||||<0.001
72608338|NCT03843372|144745311|SUPERIORITY||||||<|0.001|||||||Wilcoxon rank sum test|||The oxygen desaturation index was not a normal distribution. In the event that no carry over effect was detected between interventions, a Wilcoxon rank sum test was to be used to compare oxygen desaturation index between CPAP and HFNC||||<0.001
72608339|NCT03843372|144745312|SUPERIORITY||||||<|0.001|||||||Wilcoxon rank sum test|||The total sleep time was not a normal distribution. In the event that no carry over effect was detected between interventions, a Wilcoxon rank sum test was to be used to compare total sleep time between CPAP and HFNC||||<0.001
72417114|NCT00675766|144345016|SUPERIORITY_OR_OTHER|||||||0.72|TWO_SIDED||||||Repeated Measures ANOVA|Range of z-scores at baseline: -2.00 to 1.68. Range of z-scores at Year 1 follow-up: -2.33 to 1.90.||Repeated Measures ANOVA with memory at baseline and follow-up, computed as z-scored derived composite score of multiple neuropsychological measures assessing verbal and nonverbal learning and memory, across time as the within-group factor and HIV serostatus and age group as between-group factors.||||.72
72608340|NCT03843372|144745313|SUPERIORITY|||||||0.008|||||||Wilcoxon rank sum test|||The sleep efficiency was not a normal distribution. In the event that no carry over effect was detected between interventions, a Wilcoxon rank sum test was to be used to compare sleep efficiency between CPAP and HFNC||||0.008
72608341|NCT00902577|144745314|OTHER||Hazard Ratio (HR)|1.54||||0.048|TWO_SIDED|95.0|1.0|2.36|||Regression, Cox|||"FMISO selectively binds to hypoxic tissues so that SUVpeak within a region provides a measure of tumor hypoxia.:~This marker was modeled with a univariate Cox regression model for overall survival (OS) time. The hazard ratio, along with its 95% confidence interval and the p-value based on Wald's statistic are reported."||2.36|1.0|0.048
72608342|NCT00902577|144745314|OTHER||Hazard Ratio (HR)|1.16||||0.5|TWO_SIDED|95.0|0.75|1.81|||Regression, Cox|||T/Bmax is the pixel in the tumor region with the maximum tumor:blood ratio (T/Bmax) and T/Bmax depicts the magnitude of the hypoxia TBmax was modeled with a univariate Cox regression model for OS time. The hazard ratio, along with its 95% confidence interval and the p-value based on Wald's statistic are reported. The study was designed to enroll 46 evaluable participants to detect a log hazard ratio of 1.279 for TBmax with HV as a covariate with a 50% event rate||1.81|.75|0.50
72608343|NCT00902577|144745314|OTHER||Hazard Ratio (HR)|1.0||||0.9|TWO_SIDED|0.97|0.97|1.03|||Regression, Cox|||"Hypoxia Volume (HV) depicts the volume of tumor that has crossed the threshold for hypoxia.~Hypoxic Volume (HV) was modeled with a univariate Cox regression model for overall survival (OS) time. The hazard ratio, along with its 95% confidence interval and the p-value based on Wald's statistic are reported."||1.03|0.97|0.90
72608344|NCT00902577|144745314|OTHER||Hazard Ratio (HR)|1.17||||0.024|TWO_SIDED|95.0|1.02|1.34|||Regression, Cox||HR reported per 0.01 increase|"ktrans reflects the rate of gadolinium moves from plasma to extravascular extracellular space (predominantly though blood flow and capillary leakage).~Mean ktrans were computed using a matrix-based linearization method to fit tissue ∆R1(t) to the extended Tofts model Mean ktrans was modeled with a univariate Cox regression model for overall survival (OS) time. The hazard ratio, along with its 95% confidence interval and the p-value based on Wald's statistic are reported."||1.34|1.02|0.024
72417115|NCT00675766|144345016|SUPERIORITY_OR_OTHER|||||||0.65|TWO_SIDED||||||Repeated Measures ANOVA|Range of z-scores at baseline: -2.04 to 2.51. Range of z-scores at Year 1 follow-up: -2.21 to 2.24.||Repeated Measures ANOVA with visuospatial skills at baseline and follow-up, computed as z-scored derived composite score of multiple neuropsychological measures assessing visuospatial and visuoconstructional abilities, across time as the within-group factor and HIV serostatus and age group as between-group factors.||||0.65
72608345|NCT00902577|144745314|OTHER||Hazard Ratio (HR)|1.32||||0.045|TWO_SIDED|95.0|1.01|1.72|||Regression, Cox||HR reported per 0.01 increase|"ktrans reflects the rate of gadolinium moves from plasma to extravascular extracellular space (predominantly though blood flow and capillary leakage).~Median ktrans were computed using a matrix-based linearization method to fit tissue ∆R1(t) to the extended Tofts model.~Median ktrans was modeled with a univariate Cox regression model for overall survival (OS) time. The hazard ratio, along with its 95% confidence interval and the p-value based on Wald's statistic are reported."||1.72|1.01|0.045
72608346|NCT00902577|144745314|OTHER||Hazard Ratio (HR)|1.11||||0.31|TWO_SIDED|95.0|0.9|1.37|||Regression, Cox|||Relative cerebral blood volume (RCBV) maps, computed from the integral of ∆R2\*(t), were corrected for leakage effects and normalized to normal appearing white matter (nRCBV); nRCBV provides a measure of tumor vasculature and was modeled with a univariate Cox regression model for overall survival (OS) time. The hazard ratio, along with its 95% confidence interval and the p-value based on Wald's statistic are reported.||1.37|0.90|0.31
72608347|NCT00902577|144745314|OTHER||Hazard Ratio (HR)|1.07||||0.51|TWO_SIDED|95.0|0.88|1.29|||Regression, Cox|||cerebral blood flow (CBF) maps were was normalized to the mean of the region of interest (ROI) in normal appearing white matter to produce the nCBF and provide another measure of vascular permeability and perfusion nCBF was modeled with a univariate Cox regression model for overall survival (OS) time. The hazard ratio, along with its 95% confidence interval and the p-value based on Wald's statistic are reported.||1.29|0.88|0.51
72325379|NCT00696878|144174122|SUPERIORITY_OR_OTHER_LEGACY||Percentage with immunogenicity|0.0|||||ONE_SIDED|95.0||1.5|||||Provided limit is upper 1-sided 95% confidence limit for study population for percentage of participants with clinically relevant immunogenicity, after Cycle 3|During sample size determination, the upper limit of the one-sided 95% confidence interval for the population incidence of immunogenicity, if no immunogenicity is observed, was calculated. If no immunogenicity is observed in the projected 150 participants who receive corifollitropin alfa during 3 COS cycles, then the upper limit for the population is 2%. For the projected 300 participants who receive corifollitropin alfa during 2 COS cycles, the upper limit for the population is 1%.||1.5||
72325380|NCT00940602|144174193|OTHER|The study was not designed for confirmatory analyses. Statistical tests were performed in an exploratory sense only.|Hazard Ratio (HR)|0.636||||0.015|TWO_SIDED|95.0|0.42|0.96||Exploratory p-value is one tailed and is based on the stratified log-rank test.|Regression, Cox||95% CI was based on a Wald test from Cox model|||0.96|0.42|0.015
72325381|NCT00940602|144174194|OTHER|100 (1-α)% confidence intervals with α of 0.05 are provided|Wilson score test|12.0|||||TWO_SIDED|95.0|-1.8|25.7||||||||25.7|-1.8|
72608348|NCT00902577|144745314|OTHER||Hazard Ratio (HR)|1.0||||0.97|TWO_SIDED|95.0|0.79|1.26|||Regression, Cox|||Apparent Diffusion Coefficient (ADC) measures water diffusion through tissue. Cerebral infarction leads to diffusion restriction resulting in a low ADC signal in the infarcted area. A double Gaussian mixed model was fit to the ADC histogram and the mean of the lower ADC curve, was modeled with a univariate Cox regression model for overall survival (OS) time. The hazard ratio, along with its 95% confidence interval and the p-value based on Wald's statistic are reported.||1.26|0.79|0.9700
72608349|NCT00902577|144745314|OTHER||Hazard Ratio (HR)|0.99||||0.9007|TWO_SIDED|95.0|0.91|1.09|||Regression, Cox|||Apparent Diffusion Coefficient (ADC) measures water diffusion through tissue. Cerebral infarction leads to diffusion restriction resulting in a low ADC signal in the infarcted area. A double Gaussian mixed model was fit to the ADC histogram and the mean of the higher ADC curve, was modeled with a univariate Cox regression model for overall survival (OS) time. The hazard ratio, along with its 95% confidence interval and the p-value based on Wald's statistic are reported.||1.09|0.91|0.9007
72608350|NCT00902577|144745315|OTHER||Hazard Ratio (HR)|1.24||||0.33|TWO_SIDED|95.0|0.8|1.91|||Regression, Cox|||"FMISO selectively binds to hypoxic tissues so that SUVpeak within a region provides a measure of tumor hypoxia.~This marker was modeled with a univariate Cox regression model for Progression Free Survival time. The hazard ratio, along with its 95% confidence interval and the p-value based on Wald's statistic are reported."||1.91|.80|0.33
72417116|NCT00675766|144345016|SUPERIORITY_OR_OTHER|||||||0.79|TWO_SIDED||||||Repeated Measures ANOVA|Range of z-scores at baseline: -4.04 to 1.33. Range of z-scores at Year 1 follow-up: -1.24 to 2.37.||Repeated Measures ANOVA with motor skills at baseline and follow-up, computed as z-scored derived composite score of multiple neuropsychological measures assessing fine motor speed and dexterity, across time as the within-group factor and HIV serostatus and age group as between-group factors.||||0.79
72417117|NCT00675766|144345016|SUPERIORITY_OR_OTHER|||||||0.044|ONE_SIDED||||||Fisher Exact|One-sided Fisher's exact test with 1 degree of freedom.||Fisher's exact test compared the frequency of older and younger HIV+ adults who converted from neurocognitively intact to neurocognitively impaired on memory over a one year time period. We hypothesized that the older group would exhibit a greater proportion of individuals who declined during this interim.||||.044
72417118|NCT02275065|144345019|OTHER||||||<|0.001||||||Comparison was made using the t-test at a 2-sided 0.05 significance level.|t-test, 2 sided|||||||<0.001
72417119|NCT02275065|144345019|OTHER||||||<|0.001||||||Comparison was made using the t-test at a 2-sided 0.05 significance level.|t-test, 2 sided|||||||<0.001
72417120|NCT02275065|144345019|OTHER||||||<|0.001||||||Comparison was made using the t-test at a 2-sided 0.05 significance level.|t-test, 2 sided|||||||<0.001
72417121|NCT02275065|144345019|OTHER||||||<|0.001||||||Comparison was made using the t-test at a 2-sided 0.05 significance level.|t-test, 2 sided|||||||<0.001
72417122|NCT02275065|144345022|OTHER||||||<|0.001||||||Comparison was made using the t-test at a 2-sided 0.05 significance level.|t-test, 2 sided|||||||<0.001
72417123|NCT02275065|144345022|OTHER||||||<|0.001||||||Comparison was made using the t-test at a 2-sided 0.05 significance level.|t-test, 2 sided|||||||<0.001
72325382|NCT00940602|144174195|OTHER|The study was not designed for confirmatory analyses. Statistical tests were performed in an exploratory sense only.|Hazard Ratio (HR)|0.832||||0.2|TWO_SIDED|95.0|0.54|1.28|||Regression, Cox||95% CI was based on a Wald test from Cox model.|||1.28|0.54|0.200
72417124|NCT02275065|144345022|OTHER||||||<|0.001||||||Comparison was made using the t-test at a 2-sided 0.05 significance level.|t-test, 2 sided|||||||<0.001
72417125|NCT02275065|144345022|OTHER||||||<|0.001||||||Comparison was made using the t-test at a 2-sided 0.05 significance level.|t-test, 2 sided|||||||<0.001
72417126|NCT02275065|144345023|OTHER||||||<|0.001||||||Comparison was made using the t-test at a 2-sided 0.05 significance level.|t-test, 2 sided|||||||<0.001
72417127|NCT02275065|144345023|OTHER||||||<|0.001||||||Comparison was made using the t-test at a 2-sided 0.05 significance level.|t-test, 2 sided|||||||<0.001
72417128|NCT02275065|144345023|OTHER||||||<|0.001||||||Comparison was made using the t-test at a 2-sided 0.05 significance level.|t-test, 2 sided|||||||<0.001
72417129|NCT02275065|144345023|OTHER||||||<|0.001||||||Comparison was made using the t-test at a 2-sided 0.05 significance level.|t-test, 2 sided|||||||<0.001
72417130|NCT03015402|144345036|SUPERIORITY|Pre-randomization characteristics of 2 groups will be presented using the median (IQR) or frequency tables at each study sequence. The difference of mPAP during submax exercise compared between placebo and nitrite at 10 weeks (i.e. week 10 RHC of placebo vs week 10 RHC of nitrite) using parametric PK-cross analysis (i.e. ANOVA to determine the sequence, period, carryover, \& treatment effects). Post-exercise values before \& after crossover will be compared between 2 groups using similar approach.||||||0.2|||||||ANOVA|||||||0.20
72417131|NCT01995461|144345058|SUPERIORITY_OR_OTHER|||||||0.0252|TWO_SIDED||||||t-test, 2 sided|paired t-test||||||0.0252
72417132|NCT01995461|144345059|SUPERIORITY_OR_OTHER|||||||0.0154|TWO_SIDED||||||t-test, 2 sided|paired t-test||||||0.0154
72417133|NCT01995461|144345060|SUPERIORITY_OR_OTHER|||||||0.1349|TWO_SIDED||||||t-test, 2 sided|paired t-test||||||0.1349
72417134|NCT01201057|144345062|SUPERIORITY|||||||0.006|||||||Cochran-Mantel-Haenszel|||||||0.006
72417135|NCT01201057|144345063|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
72417136|NCT01201057|144345064|SUPERIORITY|||||||0.025|||||||Cochran-Mantel-Haenszel|||||||0.025
72417137|NCT03240692|144345085|OTHER|||||||0.036||||||False Discovery Corrected (FDR) p value. A p-value of ≤ 0.05 was considered to be statistically significant.|t-test, 2 sided|||Analysis of subgenual Anterior Cingulate Cortex (sgACC) and frontal Default Mode Network (fDMN) functional connectivity||||0.036
72417138|NCT03240692|144345085|OTHER|||||||0.008||||||False Discovery Corrected (FDR) p value. A p-value of ≤ 0.05 was considered to be statistically significant.|t-test, 2 sided|||Analysis of subgenual Anterior Cingulate Cortex (sgACC) and medial Default Mode Network (mDMN) functional connectivity||||0.008
72417139|NCT03240692|144345085|OTHER|||||||0.06||||||False Discovery Corrected (FDR) p value. A p-value of ≤ 0.05 was considered to be statistically significant.|t-test, 2 sided|||Analysis of subgenual Anterior Cingulate Cortex (sgACC) and left Default Mode Network (lDMN) functional connectivity.||||0.06
72417140|NCT03240692|144345085|OTHER|||||||0.017||||||False Discovery Corrected (FDR) p value. A p-value of ≤ 0.05 was considered to be statistically significant.|t-test, 2 sided|||Analysis of subgenual Anterior Cingulate Cortex (sgACC) and right Default Mode Network (rDMN) functional connectivity.||||0.017
72417141|NCT02300220|144345087|SUPERIORITY||Cox Proportional Hazard|1.071||||0.764|TWO_SIDED|95.0|0.684|1.676|||Regression, Cox|||The primary endpoint was assessed using a Cox's proportional hazard model with pre-specified adjustment for patient's self-reported history of exacerbations over the previous year and with stratification for study centre. The onset of exacerbation will be monitored up to 90 days or at patient withdrawal.||1.676|0.684|0.764
72417142|NCT02300220|144345088|SUPERIORITY|||||||0.703|||||||Wilcoxon (Mann-Whitney)|||||||0.703
72417143|NCT02300220|144345090|SUPERIORITY|||||||0.239|||||||t-test, 2 sided|||||||0.239
72417144|NCT04322682|144345093|SUPERIORITY||Odds Ratio (OR)|0.79||||0.081|TWO_SIDED|95.1|0.61|1.03|||Chi-squared|||||1.03|0.61|0.081
72417145|NCT04322682|144345094|SUPERIORITY||Odds Ratio (OR)|0.56||||0.291|TWO_SIDED|95.0|0.19|1.67|||Chi-squared|||||1.67|0.19|0.291
72417146|NCT04322682|144345095|SUPERIORITY||Odds Ratio (OR)|0.79||||0.077|TWO_SIDED|95.0|0.6|1.03|||Chi-squared|||||1.03|0.60|0.077
72417147|NCT04322682|144345096|SUPERIORITY||Odds Ratio (OR)|0.53||||0.08|TWO_SIDED|95.0|0.25|1.09|||Chi-squared|||||1.09|0.25|0.080
72417148|NCT04322682|144345097|SUPERIORITY||Odds Ratio (OR)|0.75||||0.042|TWO_SIDED|95.0|0.57|0.99||P-Value is for the comparison of the treatment group within patients with Covid-19 confirmed by PCR.|Regression, Logistic|Logistic-regression model including the treatment group, the PCR-confirmed Covid-19 subgroup factor (yes/no) and their interaction was performed.||||0.99|0.57|0.042
72417149|NCT00605280|144345126|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.38||||0.0047|TWO_SIDED|95.0|1.32|4.3||Adjusted for glycolated hemoglobin (HbA1c), systolic blood pressure (BP), diastolic BP, and baseline VA. Baseline values not carried forward for missing post-baseline data.|Cochran-Mantel-Haenszel|||||4.30|1.32|0.0047
72417150|NCT00605280|144345127|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.46||||0.1904|TWO_SIDED|95.0|0.85|2.53|||Cochran-Mantel-Haenszel|Adjusted for HbA1c, systolic BP, diastolic BP, and baseline VA. Baseline values were not carried forward for any missing post-baseline data.||||2.53|0.85|0.1904
72608351|NCT00902577|144745315|OTHER||Hazard Ratio (HR)|0.93||||0.72|TWO_SIDED|95.0|0.61|1.4|||Regression, Cox|||T/Bmax is the pixel in the tumor region with the maximum tumor:blood ratio (T/Bmax) and T/Bmax depicts the magnitude of the hypoxia TBmax was modeled with a univariate Cox regression model for PFS time. The hazard ratio, along with its 95% confidence interval and the p-value based on Wald's statistic are reported.||1.4|.61|0.72
72608352|NCT00902577|144745315|OTHER||Hazard Ratio (HR)|1.01||||0.355|TWO_SIDED|95.0|0.98|1.04|||Regression, Cox|||"Hypoxia Volume (HV) depicts the volume of tumor that has crossed the threshold for hypoxia.~Hypoxic Volume (HV) was modeled with a univariate Cox regression model for PFS time. The hazard ratio, along with its 95% confidence interval and the p-value based on Wald's statistic are reported."||1.04|.98|0.355
72417151|NCT00605280|144345128|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.57||||0.2466|TWO_SIDED|95.0|0.74|3.34|||Cochran-Mantel-Haenszel|Adjusted for HbA1c, systolic BP, diastolic BP, and baseline VA. Baseline values were not carried forward for any missing post-baseline data.||||3.34|0.74|0.2466
72417152|NCT00605280|144345129|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.67||||0.1388|TWO_SIDED|95.0|0.86|3.26|||Cochran-Mantel-Haenszel|Adjusted for HbA1c, systolic BP, diastolic BP, and baseline VA. Baseline values were not carried forward for any missing post-baseline data.||||3.26|0.86|0.1388
72417153|NCT00605280|144345130|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.27||||0.0468|TWO_SIDED|95.0|0.07|0.99|||Cochran-Mantel-Haenszel|Adjusted for HbA1c, systolic BP, diastolic BP, and baseline VA. Baseline values were not carried forward for any missing post-baseline data.||||0.99|0.07|0.0468
72417154|NCT00605280|144345131|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.9||||0.1124|TWO_SIDED|95.0|0.73|11.55|||Cochran-Mantel-Haenszel|Adjusted for HbA1c, systolic BP, diastolic BP, and baseline VA. Baseline values were not carried forward for any missing post-baseline data.||||11.55|0.73|0.1124
72417155|NCT00605280|144345132|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.48||||0.1788|TWO_SIDED|95.0|0.16|1.42|||Cochran-Mantel-Haenszel|Adjusted for HbA1c, systolic BP, diastolic BP, and baseline VA. Baseline values were not carried forward for any missing post-baseline data.||||1.42|0.16|0.1788
72417156|NCT00605280|144345133|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.12||||0.0048|TWO_SIDED|95.0|1.45|18.06|||Cochran-Mantel-Haenszel|Adjusted for HbA1c, systolic BP, diastolic BP, and baseline VA. Baseline values were not carried forward for any missing post-baseline data.||||18.06|1.45|0.0048
72417157|NCT00605280|144345134|SUPERIORITY_OR_OTHER||Least Squares (LS) Mean|3.9||||0.004|TWO_SIDED|95.0|1.25|6.54|||ANCOVA|Adjusted for HbA1c, systolic BP, diastolic BP, and baseline VA. Baseline values were not carried forward for any missing post-baseline data.||||6.54|1.25|0.0040
72417158|NCT00605280|144345135|SUPERIORITY_OR_OTHER||LS Mean|4.57||||0.0011|TWO_SIDED|95.0|1.85|7.29|||ANCOVA|Adjusted for HbA1c, systolic BP, diastolic BP, and baseline VA. Baseline values were not carried forward for any missing post baseline data.||||7.29|1.85|0.0011
72417159|NCT00605280|144345136|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.42||||0.0023|TWO_SIDED|95.0|0.24|0.74|||Cochran-Mantel-Haenszel|Adjusted for HbA1c, systolic BP, diastolic BP, and baseline VA. Baseline values were not carried forward for any missing post-baseline data.||||0.74|0.24|0.0023
72417160|NCT00605280|144345137|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.4||||0.0008|TWO_SIDED|95.0|0.23|0.69|||Cochran-Mantel-Haenszel|Adjusted for HbA1c, systolic BP, diastolic BP, and baseline VA. Baseline values were not carried forward for any missing post-baseline data.||||0.69|0.23|0.0008
72325383|NCT00940602|144174196|OTHER|100 (1-α)% confidence intervals with α of 0.05 are provided|Wilson score test|1.4|||||TWO_SIDED|95.0|-5.3|8.1||||||||8.1|-5.3|
72417161|NCT01662882|144345138|SUPERIORITY_OR_OTHER|||||||0.0253||95.0|||||Fisher Exact|||Fisher exact test comparing the proportion of amyloid positive subjects between clinical diagnosis groups.||||0.0253
72417162|NCT01662882|144345138|SUPERIORITY_OR_OTHER|||||||0.0004||95.0|||||Fisher Exact|||Fisher exact test comparing the proportion of amyloid positive subjects between clinical diagnosis groups.||||0.0004
72417163|NCT01662882|144345138|SUPERIORITY_OR_OTHER|||||||0.4184||95.0|||||Fisher Exact|||Fisher exact test comparing the proportion of amyloid positive subjects between clinical diagnosis groups.||||0.4184
72417164|NCT01662882|144345138|SUPERIORITY_OR_OTHER|||||||0.0008||95.0|||||Fisher Exact|||Fisher exact test comparing the proportion of amyloid positive subjects between clinical diagnosis groups.||||0.0008
72417165|NCT01662882|144345139|SUPERIORITY_OR_OTHER|||||||0.0039||95.0|||||ANOVA|||Analysis of variance P value testing for an overall difference in the mean cortical SUVR between the clinical diagnostic groups.||||0.0039
72417166|NCT01662882|144345139|SUPERIORITY_OR_OTHER|||||||0.0357||95.0|||||ANOVA|||Analysis of variance contrast P value testing for difference in the mean cortical SUVR||||0.0357
72417167|NCT01662882|144345139|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||ANOVA|||Analysis of variance contrast P value testing for difference in the mean cortical SUVR||||0.0010
72417168|NCT01662882|144345139|SUPERIORITY_OR_OTHER|||||||0.2118||95.0|||||ANOVA|||Analysis of variance contrast P value testing for difference in the mean cortical SUVR||||0.2118
72417169|NCT00205348|144345189|SUPERIORITY_OR_OTHER|||||||0.0007|||||||Wilcoxon (Mann-Whitney)|||The statistical significance of the difference between pre-and post-operative scores for Burden was tested with the Wilcoxon signed-rank test.||||0.0007
72417170|NCT00205348|144345189|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||The statistical significance of the difference between pre-and post-operative scores for Physical was tested with the Wilcoxon signed-rank test.||||<0.0001
72417171|NCT00205348|144345189|SUPERIORITY_OR_OTHER|||||||0.0002|||||||Wilcoxon (Mann-Whitney)|||The statistical significance of the difference between pre-and post-operative scores for Mental was tested with the Wilcoxon signed-rank test.||||0.0002
72417172|NCT00205348|144345189|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||The statistical significance of the difference between pre-and post-operative scores for Fear was tested with the Wilcoxon signed-rank test.||||<0.0001
72325384|NCT00940602|144174197|OTHER|100 (1-α)% confidence intervals with α of 0.05 are provided|Wilson score test|-0.3|||||TWO_SIDED|95.0|-12.0|11.4||||||||11.4|-12.0|
72417173|NCT00205348|144345189|SUPERIORITY_OR_OTHER|||||||0.0973|||||||Wilcoxon (Mann-Whitney)|||The statistical significance of the difference between pre-and post-operative scores for Eating Desire was tested with the Wilcoxon signed-rank test.||||0.0973
72417174|NCT00205348|144345189|SUPERIORITY_OR_OTHER|||||||0.1772|||||||Wilcoxon (Mann-Whitney)|||The statistical significance of the difference between pre-and post-operative scores for Eating Duration was tested with the Wilcoxon signed-rank test.||||0.1772
72417175|NCT00205348|144345189|SUPERIORITY_OR_OTHER|||||||0.0062|||||||Wilcoxon (Mann-Whitney)|||The statistical significance of the difference between pre-and post-operative scores for Food Selection was tested with the Wilcoxon signed-rank test.||||0.0062
72417176|NCT00205348|144345189|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||The statistical significance of the difference between pre-and post-operative scores for Sleep was tested with the Wilcoxon signed-rank test.||||<0.0001
72417177|NCT00205348|144345189|SUPERIORITY_OR_OTHER|||||||0.0002|||||||Wilcoxon (Mann-Whitney)|||The statistical significance of the difference between pre-and post-operative scores for Fatigue was tested with the Wilcoxon signed-rank test.||||0.0002
72417178|NCT00205348|144345189|SUPERIORITY_OR_OTHER|||||||0.2125|||||||Wilcoxon (Mann-Whitney)|||The statistical significance of the difference between pre-and post-operative scores for Social was tested with the Wilcoxon signed-rank test.||||0.2125
72417179|NCT00205348|144345189|SUPERIORITY_OR_OTHER|||||||0.0332|||||||Wilcoxon (Mann-Whitney)|||The statistical significance of the difference between pre-and post-operative scores for Communication was tested with the Wilcoxon signed-rank test.||||0.0332
72417180|NCT01311674|144345195|SUPERIORITY|||||||0.96|||||||t-test, 2 sided|||||||0.96
72417181|NCT01311674|144345196|SUPERIORITY|||||||0.36|||||||t-test, 2 sided|||||||0.36
72417182|NCT01311674|144345197|SUPERIORITY|||||||0.84|||||||Log Rank|||||||0.84
72417183|NCT01311674|144345198|SUPERIORITY|||||||0.24|||||||Log Rank|||||||0.24
72608353|NCT00902577|144745315|OTHER||Hazard Ratio (HR)|1.1||||0.074|TWO_SIDED|95.0|0.99|1.23|||Regression, Cox|||"ktrans reflects the rate of gadolinium moves from plasma to extravascular extracellular space (predominantly though blood flow and capillary leakage).~Mean ktrans were computed using a matrix-based linearization method to fit tissue ∆R1(t) to the extended Tofts model.~Mean ktrans was modeled with a univariate Cox regression model for PFS time. The hazard ratio, along with its 95% confidence interval and the p-value based on Wald's statistic are reported."||1.23|0.99|0.074
72608354|NCT00902577|144745315|OTHER||Hazard Ratio (HR)|1.3||||0.021|TWO_SIDED|95.0|1.04|1.63|||Regression, Cox|||"ktrans reflects the rate of gadolinium moves from plasma to extravascular extracellular space (predominantly though blood flow and capillary leakage).~Median ktrans were computed using a matrix-based linearization method to fit tissue ∆R1(t) to the extended Tofts model.~Median ktrans was modeled with a univariate Cox regression model for PFS time. The hazard ratio, along with its 95% confidence interval and the p-value based on Wald's statistic are reported."||1.63|1.04|0.021
72417184|NCT01311674|144345199|SUPERIORITY|||||||0.27|||||||Log Rank|||||||0.27
72417185|NCT00374322|144345200|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.91||||0.286|TWO_SIDED|95.0|0.77|1.08||The p-value was calculated from a stratified log-rank test, stratifying for hormone receptor status, time since initial diagnosis, and lymph node involvement.|Log Rank||Estimate of the treatment hazard ratio (HR) was calcuated using the pike estimator.|||1.08|0.77|0.286
72417186|NCT00450411|144345222|OTHER|||||||||||||||||It was projected that ≤10% of patients would experience late treatment-related GI/GU AEs under the protocol treatment (alternative hypothesis). A rate of ≥20% was considered unacceptable (null hypothesis). With a one-sided significance level of 0.05, it was estimated that 87 analyzable patients were required to detect the above-mentioned effect size with an 85% statistical power using Fleming's multiple testing procedure with two interim analyses and one final analysis.|Stopping Rules for a Late GI/GU Adverse Event: For 44 patients, if ≤2 then reject H0, if ≥8 then reject HA; for 73 patients, if ≤7 then reject H0, if ≥10 then reject HA; for 87 patients, if ≤10 then reject H0, if ≥11 then reject HA.|||
72417187|NCT03969719|144345234|EQUIVALENCE|The comparisons of PF-06835919 to placebo was performed at a Type I error rate of 10%.|Mean Difference (Final Values)|-12.44||||0.0696|TWO_SIDED|90.0|-22.37|-1.25|||ANCOVA|||||-1.25|-22.37|0.0696
72417188|NCT03969719|144345234|EQUIVALENCE|The comparisons of PF-06835919 to placebo was performed at a Type I error rate of 10%.|Mean Difference (Final Values)|-14.64||||0.0288|TWO_SIDED|90.0|-24.18|-3.89|||ANCOVA|||||-3.89|-24.18|0.0288
72417189|NCT03969719|144345235|EQUIVALENCE|The comparisons of PF-06835919 to placebo was performed at a Type I error rate of 10%.|Mean Difference (Final Values)|-0.08||||0.6336|TWO_SIDED|90.0|-0.36|0.2|||Mixed Models Analysis|||||0.20|-0.36|0.6336
72417190|NCT03969719|144345235|EQUIVALENCE|The comparisons of PF-06835919 to placebo was performed at a Type I error rate of 10%.|Mean Difference (Final Values)|-0.25||||0.1266|TWO_SIDED|90.0|-0.52|0.02|||Mixed Models Analysis|||||0.02|-0.52|0.1266
72417191|NCT04184791|144345247|OTHER|A linear mixed-effects analysis of variance (LM-ANOVA) model was used to determine the effect of L-Dopa, frequency, the interaction of levodopa and frequency, and the interaction of frequency and contact pairs on gait parameters. The fixed effects were L-Dopa condition (ON vs. OFF), stimulation frequency (LFS;60 Hz vs. HFS;180 Hz), contact pairs \[1-(R)/1-(L); 2-(R)/2-(L); 3-(R)/3-(L); 4-(R)/4-(L)\], and assistive device (presence vs. absence) and the patient effect was considered random.|||||<|0.05|||||||Mixed Models Analysis|||||||<0.05
72417192|NCT02130193|144345271|SUPERIORITY_OR_OTHER||Posterior mean difference|0.06|STANDARD_DEVIATION|0.06||0.87|TWO_SIDED|95.0|-0.05|0.18||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FEV1, Day 28. Data presented are for 95% equal-tailed credible intervals|||0.18|-0.05|0.87
72417193|NCT02130193|144345271|SUPERIORITY_OR_OTHER||Posterior mean difference|0.06|STANDARD_DEVIATION|0.06||0.78|TWO_SIDED|95.0|-0.05|0.18||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.02 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FEV1, Day 28. Data presented are for 95% equal-tailed credible intervals|||0.18|-0.05|0.78
72417194|NCT02130193|144345271|SUPERIORITY_OR_OTHER||Posterior mean difference|0.06|STANDARD_DEVIATION|0.06||0.67|TWO_SIDED|95.0|-0.05|0.18||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.04 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FEV1, Day 28. Data presented are for 95% equal-tailed credible intervals|||0.18|-0.05|0.67
72417195|NCT02130193|144345271|SUPERIORITY_OR_OTHER||Posterior mean difference|0.06|STANDARD_DEVIATION|0.06||0.52|TWO_SIDED|95.0|-0.05|0.18||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.06 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FEV1, Day 28. Data presented are for 95% equal-tailed credible intervals|||0.18|-0.05|0.52
72417196|NCT02130193|144345271|SUPERIORITY_OR_OTHER||Posterior mean difference|0.06|STANDARD_DEVIATION|0.06||0.39|TWO_SIDED|95.0|-0.05|0.18||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.08 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FEV1, Day 28. Data presented are for 95% equal-tailed credible intervals|||0.18|-0.05|0.39
72608355|NCT00902577|144745315|OTHER||Hazard Ratio (HR)|1.28||||0.0096|TWO_SIDED|95.0|1.06|1.54|||Regression, Cox|||"Relative cerebral blood volume (RCBV) maps, computed from the integral of ∆R2\*(t), were corrected for leakage effects and normalized to normal appearing white matter (nRCBV); nRCBV provides a measure of tumor vasculature and was modeled with a univariate Cox regression model for PFS time.~The hazard ratio, along with its 95% confidence interval and the p-value based on Wald's statistic are reported."||1.54|1.06|0.0096
72608356|NCT00902577|144745315|OTHER||Hazard Ratio (HR)|1.18||||0.038|TWO_SIDED|95.0|1.01|1.38|||Regression, Cox|||"cerebral blood flow (CBF) maps were was normalized to the mean of the region of interest (ROI) in normal appearing white matter to produce the nCBF and provide another measure of vascular permeability and perfusion.~nCBF was modeled with a univariate Cox regression model for PFS time. The hazard ratio, along with its 95% confidence interval and the p-value based on Wald's statistic are reported."||1.38|1.01|0.038
72608357|NCT00902577|144745315|OTHER||Odds Ratio (OR)|0.682||||0.3253|TWO_SIDED|95.0|0.318|1.463|||Regression, Logistic|||Logistic regression for SUVpeak to predict PFS6||1.463|0.318|0.3253
72608358|NCT00902577|144745315|OTHER||Odds Ratio (OR)|0.991||||0.9836|TWO_SIDED|95.0|0.403|2.434|||Regression, Logistic|||TBmax was modeled with a univariate logistic regression model for PFS6.||2.434|0.403|0.9836
72608359|NCT00902577|144745315|OTHER||Odds Ratio (OR)|0.957||||0.1566|TWO_SIDED|95.0|0.9|1.017|||Regression, Logistic|||Hypoxic Volume (HV) was modeled with a logistic regression model for 6month progression free survival (PFS6) .||1.017|0.900|0.1566
72608360|NCT00902577|144745315|OTHER||Odds Ratio (OR)|0.993||||0.9554|TWO_SIDED|95.0|0.775|1.273|||Regression, Logistic|||"Mean ktrans were computed using a matrix-based linearization method to fit tissue ∆R1(t) to the extended Tofts model.~Mean ktrans was modeled with a univariate logistic regression model for PFS6."||1.273|0.775|0.9554
72608361|NCT00902577|144745315|OTHER||Odds Ratio (OR)|0.919||||0.6941|TWO_SIDED|95.0|0.602|1.402|||Regression, Logistic|||"Median ktrans were computed using a matrix-based linearization method to fit tissue ∆R1(t) to the extended Tofts model.~Median ktrans was modeled with a univariate logistic regression model for PFS6"||1.402|0.602|0.6941
72608362|NCT00902577|144745315|OTHER||Odds Ratio (OR)|0.744||||0.134|TWO_SIDED|95.0|0.506|1.095|||Regression, Logistic|||"Relative cerebral blood volume (RCBV) maps were corrected for leakage effects and normalized to normal appearing white matter (nRCBV).~nRCBV was modeled with a univariate logistic regression model for PFS6."||1.095|0.506|0.1340
72608363|NCT00902577|144745315|OTHER||Odds Ratio (OR)|0.821||||0.2642|TWO_SIDED|95.0|0.58|1.161|||Regression, Logistic|||"cerebral blood flow (CBF) maps were was normalized to the mean of the region of interest (ROI) in normal appearing white matter to produce the nCBF.~nCBF was modeled with a univariate logistic regression model for PFS6."||1.161|0.580|0.2642
72608364|NCT00902577|144745315|OTHER||Odds Ratio (OR)|0.855||||0.5069|TWO_SIDED|95.0|0.539|1.357|||Regression, Logistic|||Apparent Diffusion Coefficient (ADC) low values were modeled with a univariate logistic regression model for PFS6||1.357|0.539|0.5069
72608365|NCT00902577|144745315|OTHER||Odds Ratio (OR)|0.884||||0.1921|TWO_SIDED|95.0|0.735|1.064|||Regression, Logistic|||Apparent Diffusion Coefficient (ADC) high values were modeled with a univariate Logistic regression model for PFS6||1.064|0.735|0.1921
72608366|NCT00902577|144745315|OTHER|An Area Under the Curve (AUC) with a lower bound of at least 0.5 is considered statistically significant.|Area Under the Curve (AUC)|0.61|||||TWO_SIDED|95.0|0.42|0.79||||||"FMISO selectively binds to hypoxic tissues so that SUVpeak within a region provides a measure of tumor hypoxia.~Receiver Operating Characteristic(ROC) analysis was perform to determine the accuracy of this marker to predict PFS9."||0.79|0.42|
72608367|NCT00902577|144745315|OTHER|An Area Under the Curve (AUC) with a lower bound of at least 0.5 is considered statistically significant.|Area Under the Curve (AUC)|0.59|||||TWO_SIDED|95.0|0.39|0.78||||||"T/Bmax is the pixel in the tumor region with the maximum tumor:blood ratio (T/Bmax) and T/Bmax depicts the magnitude of the hypoxia.~Receiver Operating Characteristic(ROC) analysis was perform to determine the accuracy of this marker to predict PFS9."||0.78|0.39|
72608368|NCT00902577|144745315|OTHER|An Area Under the Curve (AUC) with a lower bound of at least 0.5 is considered statistically significant.|Area Under the Curve (AUC)|0.64|||||TWO_SIDED|95.0|0.46|0.83||||||"Hypoxia Volume (HV) depicts the volume of tumor that has crossed the threshold for hypoxia.~Receiver Operating Characteristic(ROC) analysis was perform to determine the accuracy of this marker to predict PFS9."||0.83|0.46|
72608369|NCT00902577|144745315|OTHER|An Area Under the Curve (AUC) with a lower bound of at least 0.5 is considered statistically significant.|Area Under the Curve (AUC)|0.62|||||TWO_SIDED|95.0|0.42|0.83||||||"mean ktrans reflects the rate of gadolinium moves from plasma to extravascular extracellular space (predominantly though blood flow and capillary leakage).~Receiver Operating Characteristic(ROC) analysis was perform to determine the accuracy of mean ktrans to predict PFS9."||0.83|0.42|
72608370|NCT00902577|144745315|OTHER|An Area Under the Curve (AUC) with a lower bound of at least 0.5 is considered statistically significant.|Area Under the Curve (AUC)|0.64|||||TWO_SIDED|95.0|0.44|0.84||||||"Median ktrans reflects the rate of gadolinium moves from plasma to extravascular extracellular space (predominantly though blood flow and capillary leakage).~Receiver Operating Characteristic(ROC) analysis was perform to determine the accuracy of Median ktrans to predict PFS9."||0.84|0.44|
72608371|NCT00902577|144745315|OTHER|An Area Under the Curve (AUC) with a lower bound of at least 0.5 is considered statistically significant.|Area Under the Curve (AUC)|0.72|||||TWO_SIDED|95.0|0.54|0.89||||||nRCBV provides a measure of tumor vasculature Receiver Operating Characteristic(ROC) analysis was perform to determine the accuracy of this marker to predict PFS9.||0.89|0.54|
72608372|NCT00902577|144745315|OTHER|An Area Under the Curve (AUC) with a lower bound of at least 0.5 is considered statistically significant.|Area Under the Curve (AUC)|0.72|||||TWO_SIDED|95.0|0.55|0.89||||||nCBF provides a measure of vascular permeability and perfusion. Receiver Operating Characteristic(ROC) analysis was perform to determine the accuracy of this marker to predict PFS9.||0.89|0.55|
72325385|NCT00940602|144174198|OTHER|The study was not designed for confirmatory analyses. Statistical tests were performed in an exploratory sense only.|Hazard Ratio (HR)|0.725||||0.184|TWO_SIDED|95.0|0.36|1.46|||Regression, Cox||95% CI was based on a Wald test from Cox model.|||1.46|0.36|0.184
72417197|NCT02130193|144345271|SUPERIORITY_OR_OTHER||Posterior mean difference|0.06|STANDARD_DEVIATION|0.06||0.26|TWO_SIDED|95.0|-0.05|0.18||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.10 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FEV1, Day 28. Data presented are for 95% equal-tailed credible intervals|||0.18|-0.05|0.26
72417198|NCT02130193|144345271|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.04|STANDARD_DEVIATION|0.07||0.31|TWO_SIDED|95.0|-0.2|0.09||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FEV1, Day 56. Data presented are for 95% equal-tailed credible intervals|||0.09|-0.20|0.31
72417199|NCT02130193|144345271|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.04|STANDARD_DEVIATION|0.07||0.22|TWO_SIDED|95.0|-0.2|0.09||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.02 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FEV1, Day 56. Data presented are for 95% equal-tailed credible intervals|||0.09|-0.20|0.22
72417200|NCT02130193|144345271|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.04|STANDARD_DEVIATION|0.07||0.14|TWO_SIDED|95.0|-0.2|0.09||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.04 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FEV1, Day 56. Data presented are for 95% equal-tailed credible intervals|||0.09|-0.20|0.14
72417201|NCT02130193|144345271|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.04|STANDARD_DEVIATION|0.07||0.09|TWO_SIDED|95.0|-0.2|0.09||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.06 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FEV1, Day 56. Data presented are for 95% equal-tailed credible intervals|||0.09|-0.20|0.09
72417202|NCT02130193|144345271|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.04|STANDARD_DEVIATION|0.07||0.05|TWO_SIDED|95.0|-0.2|0.09||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.08 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FEV1, Day 56. Data presented are for 95% equal-tailed credible intervals|||0.09|-0.20|0.05
72417203|NCT02130193|144345271|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.04|STANDARD_DEVIATION|0.07||0.03|TWO_SIDED|95.0|-0.2|0.09||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.10 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FEV1, Day 56. Data presented are for 95% equal-tailed credible intervals|||0.09|-0.20|0.03
72417204|NCT02130193|144345271|SUPERIORITY_OR_OTHER||Posterior mean difference|0.08|STANDARD_DEVIATION|0.08||0.85|TWO_SIDED|95.0|-0.06|0.23||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FEV1, Day 112. Data presented are for 95% equal-tailed credible intervals|||0.23|-0.06|0.85
72417205|NCT02130193|144345271|SUPERIORITY_OR_OTHER||Posterior mean difference|0.08|STANDARD_DEVIATION|0.08||0.79|TWO_SIDED|95.0|-0.06|0.23||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.02 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FEV1, Day 112. Data presented are for 95% equal-tailed credible intervals|||0.23|-0.06|0.79
72417206|NCT02130193|144345271|SUPERIORITY_OR_OTHER||Posterior mean difference|0.08|STANDARD_DEVIATION|0.08||0.71|TWO_SIDED|95.0|-0.06|0.23||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.04 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FEV1, Day 112. Data presented are for 95% equal-tailed credible intervals|||0.23|-0.06|0.71
72417207|NCT02130193|144345271|SUPERIORITY_OR_OTHER||Posterior mean difference|0.08|STANDARD_DEVIATION|0.08||0.61|TWO_SIDED|95.0|-0.06|0.23||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.06 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FEV1, Day 112. Data presented are for 95% equal-tailed credible intervals|||0.23|-0.06|0.61
72417208|NCT02130193|144345271|SUPERIORITY_OR_OTHER||Posterior mean difference|0.08|STANDARD_DEVIATION|0.08||0.51|TWO_SIDED|95.0|-0.06|0.23||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.08 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FEV1, Day 112. Data presented are for 95% equal-tailed credible intervals|||0.23|-0.06|0.51
72417209|NCT02130193|144345271|SUPERIORITY_OR_OTHER||Posterior mean difference|0.08|STANDARD_DEVIATION|0.08||0.41|TWO_SIDED|95.0|-0.06|0.23||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.10 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FEV1, Day 112. Data presented are for 95% equal-tailed credible intervals|||0.23|-0.06|0.41
72417210|NCT02130193|144345271|SUPERIORITY_OR_OTHER||Posterior mean difference|0.0|STANDARD_DEVIATION|0.07||0.47|TWO_SIDED|95.0|-0.16|0.14||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FEV1, Day 168. Data presented are for 95% equal-tailed credible intervals|||0.14|-0.16|0.47
72417211|NCT02130193|144345271|SUPERIORITY_OR_OTHER||Posterior mean difference|0.0|STANDARD_DEVIATION|0.07||0.36|TWO_SIDED|95.0|-0.16|0.14||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.02 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FEV1, Day 168. Data presented are for 95% equal-tailed credible intervals|||0.14|-0.16|0.36
72417212|NCT02130193|144345271|SUPERIORITY_OR_OTHER||Posterior mean difference|0.0|STANDARD_DEVIATION|0.07||0.26|TWO_SIDED|95.0|-0.16|0.14||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.04 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FEV1, Day 168. Data presented are for 95% equal-tailed credible intervals|||0.14|-0.16|0.26
72417213|NCT02130193|144345271|SUPERIORITY_OR_OTHER||Posterior mean difference|0.0|STANDARD_DEVIATION|0.07||0.19|TWO_SIDED|95.0|-0.16|0.14||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.06 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FEV1, Day 168. Data presented are for 95% equal-tailed credible intervals|||0.14|-0.16|0.19
72417214|NCT02130193|144345271|SUPERIORITY_OR_OTHER||Posterior mean difference|0.0|STANDARD_DEVIATION|0.07||0.13|TWO_SIDED|95.0|-0.16|0.14||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.08 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FEV1, Day 168. Data presented are for 95% equal-tailed credible intervals|||0.14|-0.16|0.13
72608373|NCT03238417|144745330|NON_INFERIORITY|Analysis of Variance comparing change in outcome between EBQI and control from baseline to 12 month.|Mean Difference (Net)|-0.65|STANDARD_ERROR_OF_MEAN|1.32||0.623|TWO_SIDED|95.0|-3.3|2.0||P-value is from the interaction term between EBQI and time.|ANOVA|||||2.0|-3.3|0.623
72325386|NCT00940602|144174199|OTHER|The study was not designed for confirmatory analyses. Statistical tests were performed in an exploratory sense only.|Hazard Ratio (HR)|0.195|||<|0.001|TWO_SIDED|95.0|0.11|0.36|||Regression, Cox||95% CI was based on a Wald test from Cox model.|||0.36|0.11|<.001
72417215|NCT02130193|144345271|SUPERIORITY_OR_OTHER||Posterior mean difference|0.0|STANDARD_DEVIATION|0.07||0.09|TWO_SIDED|95.0|-0.16|0.14||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.10 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FEV1, Day 168. Data presented are for 95% equal-tailed credible intervals|||0.14|-0.16|0.09
72608374|NCT03238417|144745331|NON_INFERIORITY|Analysis of Variance testing for change in outcome between EBQI and control from baseline to 24 months.|Mean Difference (Net)|-0.48|STANDARD_ERROR_OF_MEAN|1.1||0.678|TWO_SIDED|95.0|-2.8|1.8||P-value is from the interaction term of EBQI and time.|ANOVA|||||1.8|-2.8|0.678
72608375|NCT03238417|144745332|SUPERIORITY|Difference-in-differences analysis using linear regression, adjusted for age, how often they saw women patients in the past year, location of practice in primary care or women's health clinic, and having had any type of quality improvement training. We adjusted our analysis with non-response weights.|Mean Difference (Final Values)|0.09|STANDARD_ERROR_OF_MEAN|0.13||0.364|TWO_SIDED|95.0|-0.17|0.35||P-value is from the interaction term between EBQI and time, adjusted for non-response weights and characteristics described in the statistical analysis overview.|Regression, Linear||The estimated value reported here is the predicted mean change from baseline to 12-month, adjusting for characteristics described in the statistical analysis overview.|Change in gender awareness score between EBQI and control from baseline to 12-month||0.35|-0.17|0.364
72608376|NCT03238417|144745333|SUPERIORITY|Difference-in-differences analysis using linear regression, adjusted for age, how often they saw women patients in the past year, location of practice in primary care or women's health clinic, and having had any type of quality improvement training. We adjusted our analysis with non-response weights.|Mean Difference (Final Values)|-0.11|STANDARD_ERROR_OF_MEAN|0.1||0.29|TWO_SIDED|95.0|-0.33|0.1||P-value reflects the interaction term between EBQI and time, adjusted for non-response weights and characteristics described in the statistical analysis overview.|Regression, Linear||The estimated value reported here is the predicted mean change from baseline to 24-month, adjusting for characteristics described in the statistical analysis overview.|Change in gender awareness score between EBQI and control from baseline to 24-month||0.10|-0.33|0.29
72608377|NCT03238417|144745334|SUPERIORITY|Difference-in-differences analysis using logistic regression. The number of activities were recoded into 0 vs 1+ activities. The model was adjusted for age, how often they saw women patients in the past year, location of practice in primary care or women's health clinic, and having had any type of quality improvement training. We also adjusted for non-response weights.|Odds Ratio (OR)|-0.69|STANDARD_ERROR_OF_MEAN|0.42||0.1|TWO_SIDED|95.0|-1.52|0.13||P-value is from the interaction term between EBQI and time, adjusted for non-response weights and characteristics described in the statistical analysis overview.|Difference-in-Differences analysis||The estimated value is predicted change in the odds of involving in one or more quality improvement activities, adjusting for characteristics described in the statistical analysis overview.|||0.13|-1.52|0.10
72608378|NCT03238417|144745335|SUPERIORITY|Difference-in-differences analysis using logistic regression. The number of activities were recoded into 0 vs 1+ activities. The model was adjusted for age, how often they saw women patients in the past year, location of practice in primary care or women's health clinic, and having had any type of quality improvement training. We also adjusted for non-response weights.|Odds Ratio (OR)|-0.48|STANDARD_ERROR_OF_MEAN|0.39||0.22|TWO_SIDED|95.0|-1.25|0.29||P-value is from the interaction term between EBQI and time, adjusted for non-response weights and characteristics described in the statistical analysis overview.|Regression, Logistic||The estimated value is predicted change in the odds of involving in one or more quality improvement activities, adjusting for characteristics described in the statistical analysis overview.|||0.29|-1.25|0.22
72608379|NCT03238417|144745336|NON_INFERIORITY|Analysis of Variance testing the differences in outcome between EBQI and control groups over 12 month period.|Mean Difference (Net)|-0.08|STANDARD_ERROR_OF_MEAN|3.1||0.788|TWO_SIDED|95.0|-7.1|5.4||The p-value reflects the interaction term between EBQI and time|ANOVA|||||5.4|-7.1|0.788
72608380|NCT03238417|144745337|NON_INFERIORITY|Analysis of Variance testing for differences in outcomes between EBQI and control arms from baseline to 24 months.|Mean Difference (Net)|-1.5|STANDARD_ERROR_OF_MEAN|2.89||0.61|TWO_SIDED|95.0|-7.35|4.35||The p-value reflects the interaction terms between EBQI and control arms.|ANOVA|||||4.35|-7.35|0.61
72608381|NCT03238417|144745338|NON_INFERIORITY|ANOVA comparing changes in outcome over time between EBQI and control arms|Mean Difference (Net)|-0.17|STANDARD_ERROR_OF_MEAN|10.5||0.987|TWO_SIDED|95.0|-21.45|21.11||The p-value reflects the interaction term between EBQI and time|ANOVA|||||21.11|-21.45|0.987
72608382|NCT03238417|144745339|NON_INFERIORITY|ANOVA comparing changes in outcome over time between EBQI and control groups|Mean Difference (Net)|-3.91|STANDARD_ERROR_OF_MEAN|10.35||0.708|TWO_SIDED|95.0|-24.89|17.08||The p-value reflects the interaction terms between EBQI and time|ANOVA|||||17.08|-24.89|0.708
72608383|NCT03238417|144745340|NON_INFERIORITY|ANOVA comparing changes in outcome over time between EBQI and control groups|Mean Difference (Net)|-4.51|STANDARD_ERROR_OF_MEAN|8.85||0.613|TWO_SIDED|95.0|-22.43|13.4||The p-value reflects the interaction term between EBQI and time|ANOVA|||||13.40|-22.43|0.613
72608384|NCT03238417|144745341|NON_INFERIORITY|ANOVA comparing changes in outcome over time between EBQI and control groups|Mean Difference (Net)|0.94|STANDARD_ERROR_OF_MEAN|9.48||0.922|TWO_SIDED|95.0|-18.26|20.13||The p-value reflects the interaction term between EBQI and time.|ANOVA|||||20.13|-18.26|0.922
72325387|NCT00940602|144174200|OTHER|The study was not designed for confirmatory analyses. Statistical tests were performed in an exploratory sense only.|Hazard Ratio (HR)|0.871||||0.303|TWO_SIDED|95.0|0.52|1.46|||Regression, Cox||95% CI was based on a Wald test from Cox model.|||1.46|0.52|0.303
72325388|NCT00940602|144174201|OTHER|The study was not designed for confirmatory analyses. Statistical tests were performed in an exploratory sense only.|Hazard Ratio (HR)|1.072||||0.389|TWO_SIDED|95.0|0.66|1.75|||Regression, Cox||95% CI was based on a Wald test from Cox model.|||1.75|0.66|0.389
72608385|NCT03238417|144745342|NON_INFERIORITY|two-way ANOVA testing change in a composite score of gender-neutral preventive care between EBQI and control arms over time|Mean Difference (Net)|0.58|STANDARD_ERROR_OF_MEAN|2.13||0.789|TWO_SIDED|95.0|-3.74|4.89||The p-value represents the interaction term between EBQI and control.|ANOVA|||||4.89|-3.74|0.789
72417216|NCT02130193|144345271|SUPERIORITY_OR_OTHER||Posterior mean difference|0.06|STANDARD_DEVIATION|0.08||0.78|TWO_SIDED|95.0|-0.11|0.2||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FEV1, Day 280. Data presented are for 95% equal-tailed credible intervals|||0.20|-0.11|0.78
72417217|NCT02130193|144345271|SUPERIORITY_OR_OTHER||Posterior mean difference|0.06|STANDARD_DEVIATION|0.08||0.69|TWO_SIDED|95.0|-0.11|0.2||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.02 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FEV1, Day 280. Data presented are for 95% equal-tailed credible intervals|||0.20|-0.11|0.69
72417218|NCT02130193|144345271|SUPERIORITY_OR_OTHER||Posterior mean difference|0.06|STANDARD_DEVIATION|0.08||0.59|TWO_SIDED|95.0|-0.11|0.2||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.04 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FEV1, Day 280. Data presented are for 95% equal-tailed credible intervals|||0.20|-0.11|0.59
72417219|NCT02130193|144345271|SUPERIORITY_OR_OTHER||Posterior mean difference|0.06|STANDARD_DEVIATION|0.08||0.5|TWO_SIDED|95.0|-0.11|0.2||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.06 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FEV1, Day 280. Data presented are for 95% equal-tailed credible intervals|||0.20|-0.11|0.50
72417220|NCT02130193|144345271|SUPERIORITY_OR_OTHER||Posterior mean difference|0.06|STANDARD_DEVIATION|0.08||0.39|TWO_SIDED|95.0|-0.11|0.2||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.08 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FEV1, Day 280. Data presented are for 95% equal-tailed credible intervals|||0.20|-0.11|0.39
72417221|NCT02130193|144345271|SUPERIORITY_OR_OTHER||Posterior mean difference|0.06|STANDARD_DEVIATION|0.08||0.3|TWO_SIDED|95.0|-0.11|0.2||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.10 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FEV1, Day 280. Data presented are for 95% equal-tailed credible intervals|||0.20|-0.11|0.30
72608386|NCT03238417|144745343|NON_INFERIORITY|ANOVA comparing changes in outcomes over time between EBQI and control groups|Mean Difference (Net)|-1.63|STANDARD_ERROR_OF_MEAN|2.45||0.51|TWO_SIDED|95.0|-6.6|3.33||The p-value reflects the interaction between EBQI and time.|ANOVA|The analysis is adjusted for EBQI and time.||||3.33|-6.60|0.51
72608387|NCT03238417|144745344|NON_INFERIORITY|ANOVA testing for change in outcome over time between EBQI and control arms|Mean Difference (Net)|3.11|STANDARD_ERROR_OF_MEAN|8.3||0.711|TWO_SIDED|95.0|-13.7|19.9||The p-value reflects the interaction between EBQI and time|ANOVA|||||19.9|-13.7|0.711
72608388|NCT03238417|144745345|NON_INFERIORITY|ANOVA comparing changes in outcome over time between EBQI and control arms|Mean Difference (Net)|8.49|STANDARD_ERROR_OF_MEAN|8.7||0.335|TWO_SIDED|95.0|-9.1|26.1||The p-value reflects the interaction term between EBQI and time.|ANOVA|||||26.1|-9.1|0.335
72325389|NCT00940602|144174203|OTHER|100 (1-α)% confidence intervals with α of 0.05 are provided|Wilson score test|1.5|||||TWO_SIDED|95.0|-5.2|8.1||||||||8.1|-5.2|
72417222|NCT02130193|144345271|SUPERIORITY_OR_OTHER||Posterior mean difference|0.04|STANDARD_DEVIATION|0.08||0.68|TWO_SIDED|95.0|-0.14|0.2||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FEV1, Day 364. Data presented are for 95% equal-tailed credible intervals|||0.20|-0.14|0.68
72417223|NCT02130193|144345271|SUPERIORITY_OR_OTHER||Posterior mean difference|0.04|STANDARD_DEVIATION|0.08||0.59|TWO_SIDED|95.0|-0.14|0.2||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.02 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FEV1, Day 364. Data presented are for 95% equal-tailed credible intervals|||0.20|-0.14|0.59
72417224|NCT02130193|144345271|SUPERIORITY_OR_OTHER||Posterior mean difference|0.04|STANDARD_DEVIATION|0.08||0.5|TWO_SIDED|95.0|-0.14|0.2||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.04 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FEV1, Day 364. Data presented are for 95% equal-tailed credible intervals|||0.20|-0.14|0.50
72417225|NCT02130193|144345271|SUPERIORITY_OR_OTHER||Posterior mean difference|0.04|STANDARD_DEVIATION|0.08||0.4|TWO_SIDED|95.0|-0.14|0.2||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.06 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FEV1, Day 364. Data presented are for 95% equal-tailed credible intervals|||0.20|-0.14|0.40
72325390|NCT00940602|144174204|OTHER|100 (1-α)% confidence intervals with α of 0.05 are provided|Wilson score test|0.7|||||TWO_SIDED|95.0|-1.6|3.0||||||||3.0|-1.6|
72417226|NCT02130193|144345271|SUPERIORITY_OR_OTHER||Posterior mean difference|0.04|STANDARD_DEVIATION|0.08||0.3|TWO_SIDED|95.0|-0.14|0.2||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.08 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FEV1, Day 364. Data presented are for 95% equal-tailed credible intervals|||0.20|-0.14|0.30
72608389|NCT03238417|144745346|NON_INFERIORITY|Analysis of Variance testing for change in outcome between EBQI and control groups from baseline to 12 months.|Mean Difference (Net)|-13.8|STANDARD_ERROR_OF_MEAN|12.3||0.268|TWO_SIDED|95.0|-38.7|11.1||P-value is from the interaction term between EBQI and time.|ANOVA|||||11.1|-38.7|0.268
72608390|NCT03238417|144745347|NON_INFERIORITY|Analysis of Variance testing the differences between EBQI and control from baseline and 24 months|Mean Difference (Net)|-0.14|STANDARD_ERROR_OF_MEAN|12.6||0.991|TWO_SIDED|95.0|-25.6|25.3||P-value is from the interaction between EBQI and time.|ANOVA|||||25.3|-25.6|0.991
72608391|NCT00501631|144745377|SUPERIORITY_OR_OTHER|||||||0.336||95.0|||||Van der Waerden test|||The null hypothesis that there is no difference between two treatment groups (i.e. Placebo and Vivitrol) was tested using a two-sided Van der Waerden test. Response profiles were tabulated as a cumulative percent of subjects at each decile of percent heavy drinking days.||||0.336
72608392|NCT04456686|144745382|SUPERIORITY||Posterior Mean Difference|-0.03|||||TWO_SIDED|95.0|-0.77|0.7|||Bayesian Mixed Model Analysis|||||0.70|-0.77|
72608393|NCT04456686|144745383|SUPERIORITY||Posterior Mean Difference|0.58|||||TWO_SIDED|95.0|-0.82|1.96|||Bayesian Mixed Model Analysis|||||1.96|-0.82|
72608394|NCT04456686|144745384|SUPERIORITY||Posterior Mean Difference|0.1|||||TWO_SIDED|95.0|-0.45|0.63|||Bayesian Mixed Model Analysis|||||0.63|-0.45|
72608395|NCT04456686|144745385|SUPERIORITY||Posterior Mean Difference|0.9|||||TWO_SIDED|95.0|-3.31|5.06|||Bayesian Mixed Model Analysis|||||5.06|-3.31|
72608396|NCT04456686|144745386|SUPERIORITY||Posterior Mean Difference|0.03|||||TWO_SIDED|95.0|-0.46|0.5|||Bayesian Mixed Model Analysis|||||0.50|-0.46|
72608397|NCT04456686|144745387|SUPERIORITY||Posterior Mean Difference|0.11|||||TWO_SIDED|95.0|-0.72|0.91|||Bayesian Mixed Model Analysis|||||0.91|-0.72|
72608398|NCT04456686|144745388|SUPERIORITY||Posterior Mean Difference|2.45|||||TWO_SIDED|95.0|-7.27|12.2|||Bayesian Mixed Model Analysis|||||12.20|-7.27|
72608399|NCT04456686|144745389|SUPERIORITY||Posterior Mean Difference|0.4|||||TWO_SIDED|95.0|-0.04|0.85|||Bayesian Mixed Model Analysis|||||0.85|-0.04|
72608400|NCT04456686|144745390|SUPERIORITY||Posterior Mean Difference|168.61|||||TWO_SIDED|95.0|-38.22|379.2|||Bayesian Mixed Model Analysis|||||379.20|-38.22|
72608401|NCT04456686|144745391|SUPERIORITY||Posterior Mean Difference|-0.01|||||TWO_SIDED|95.0|-0.07|0.06|||Bayesian Mixed Model Analysis|||||0.06|-0.07|
72608402|NCT01329198|144745397|SUPERIORITY||Mean Difference (Final Values)|-17.8|STANDARD_DEVIATION|9.4||0.013|TWO_SIDED||||||ANOVA||Mean change in YGTSS scores from Baseline to 6 Months across all study participants presented.|||||0.013
72608403|NCT00473083|144745399|SUPERIORITY_OR_OTHER|||||||0.8769||||||P for arm 1 v arms 2 and 3 combined|Chi-squared|||||||0.8769
72608404|NCT00473083|144745399|SUPERIORITY_OR_OTHER|||||||0.147||||||P for arm 1 v arms 2 and 3 combined|Wilcoxon (Mann-Whitney)|||||||0.147
72608405|NCT00473083|144745400|SUPERIORITY_OR_OTHER|||||||0.1503||||||P(arm 1 v arm 2) in patients with maximum severity of rash grade 1, 2a, or 2b|Wilcoxon (Mann-Whitney)|||||||0.1503
72608406|NCT00473083|144745400|SUPERIORITY_OR_OTHER|||||||0.4681||||||P(arm2 v arm3) in patients with maximum severity of rash grade 1, 2a, or 2b|Wilcoxon (Mann-Whitney)|||||||0.4681
72325391|NCT00940602|144174205|OTHER|100 (1-α)% confidence intervals with α of 0.05 are provided|Wilson score test|1.4|||||TWO_SIDED|95.0|-11.9|14.6||||||||14.6|-11.9|
72608407|NCT00473083|144745400|SUPERIORITY_OR_OTHER|||||||0.0196||||||P(arm 1 v arm 3) in patients with maximum severity of rash grade 1, 2a, or 2b|Wilcoxon (Mann-Whitney)|||||||0.0196
72608408|NCT00473083|144745400|SUPERIORITY_OR_OTHER|||||||0.1658||||||P(arm 1 v arm 2) in patients with maximum severity of rash grade 3|Wilcoxon (Mann-Whitney)|||||||0.1658
72608409|NCT00473083|144745400|SUPERIORITY_OR_OTHER||||||>|0.9999||||||"P(arm 2 v arm 3) in patients with maximum severity of rash grade 3.~P-value was calculated to be \>0.9999 using the Wilcoxon Rank Sumtest by comparing between the two treatment arms."|Wilcoxon (Mann-Whitney)|||||||>0.9999
72608410|NCT00473083|144745400|SUPERIORITY_OR_OTHER|||||||0.285||||||P(arm 1 v arm 3) in patients with maximum severity of rash grade 3|Wilcoxon (Mann-Whitney)|||||||0.285
72608411|NCT00473083|144745401|SUPERIORITY_OR_OTHER|||||||0.5097|||||||Chi-squared|||Maximal Rash Grade 1||||0.5097
72608412|NCT00473083|144745401|SUPERIORITY_OR_OTHER|||||||0.474|||||||Chi-squared|||Maximal Rash Grade 2a||||0.4740
72608413|NCT00473083|144745401|SUPERIORITY_OR_OTHER|||||||0.2123|||||||Chi-squared|||Maximal Severity Grade 2b||||0.2123
72608414|NCT00473083|144745401|SUPERIORITY_OR_OTHER|||||||0.5004|||||||Chi-squared|||Maximal Severity Grade 3||||0.5004
72608415|NCT00473083|144745401|SUPERIORITY_OR_OTHER|||||||0.9072|||||||Chi-squared|||Maximal Severity Grade 1||||0.9072
72608416|NCT00473083|144745401|SUPERIORITY_OR_OTHER|||||||0.0464|||||||Chi-squared|||Maximal Severity Grade 2a||||0.0464
72608417|NCT00473083|144745401|SUPERIORITY_OR_OTHER|||||||0.6759|||||||Chi-squared|||Maximal Severity Grade 2b||||0.6759
72608418|NCT00473083|144745401|SUPERIORITY_OR_OTHER|||||||0.0065|||||||Chi-squared|||Maximal Severity Grade 3||||0.0065
72608419|NCT00473083|144745401|SUPERIORITY_OR_OTHER|||||||0.5898|||||||Chi-squared|||Maximal Severity Grade 1||||0.5898
72608420|NCT00473083|144745401|SUPERIORITY_OR_OTHER|||||||0.1921|||||||Chi-squared|||Maximal Severity Grade 2a||||0.1921
72608421|NCT00473083|144745401|SUPERIORITY_OR_OTHER|||||||0.0882|||||||Chi-squared|||Maximal Severity Grade 2b||||0.0882
72608422|NCT00473083|144745401|SUPERIORITY_OR_OTHER|||||||0.0344|||||||Chi-squared|||Maximal Severity Grade 3||||0.0344
72608423|NCT00473083|144745402|SUPERIORITY_OR_OTHER|||||||0.3834|||||||Log Rank|||||||0.3834
72608424|NCT00473083|144745404|SUPERIORITY_OR_OTHER|||||||0.0147|||||||Wilcoxon (Mann-Whitney)|||||||0.0147
72608425|NCT02915835|144745406|SUPERIORITY|||||||0.7|||||||ANCOVA|||||||0.70
72608426|NCT02915835|144745407|SUPERIORITY|||||||0.61|||||||Fisher Exact|||||||0.61
72608427|NCT02915835|144745408|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.00
72608428|NCT02915835|144745409|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.00
72608429|NCT02915835|144745410|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.00
72608430|NCT02915835|144745411|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.00
72608431|NCT02915835|144745412|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.00
72608432|NCT02915835|144745413|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.00
72608433|NCT02915835|144745414|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.00
72608434|NCT02915835|144745415|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.00
72608435|NCT02915835|144745416|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.00
72608436|NCT02915835|144745417|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.00
72608437|NCT02915835|144745418|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.00
72608438|NCT02915835|144745419|SUPERIORITY|||||||0.56|||||||Log Rank|||||||.56
72608439|NCT02915835|144745420|SUPERIORITY|||||||0.35|||||||Log Rank|||||||.35
72608440|NCT02915835|144745422|SUPERIORITY|||||||0.76|||||||ANCOVA|||||||.76
72608441|NCT02915835|144745423|SUPERIORITY|||||||0.57|||||||ANCOVA|||||||.57
72608442|NCT02915835|144745424|SUPERIORITY|||||||0.4|||||||ANCOVA|||||||.40
72608443|NCT02915835|144745425|SUPERIORITY|||||||0.49|||||||ANCOVA|||||||.49
72417227|NCT02130193|144345271|SUPERIORITY_OR_OTHER||Posterior mean difference|0.04|STANDARD_DEVIATION|0.08||0.22|TWO_SIDED|95.0|-0.14|0.2||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.10 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FEV1, Day 364. Data presented are for 95% equal-tailed credible intervals|||0.20|-0.14|0.22
72325392|NCT00940602|144174206|OTHER|100 (1-α)% confidence intervals with α of 0.05 are provided|Wilson score test|-9.6|||||TWO_SIDED|95.0|-20.8|1.6||||||||1.6|-20.8|
72325393|NCT00940602|144174207|OTHER|The study was not designed for confirmatory analyses. Statistical tests were performed in an exploratory sense only.|Hazard Ratio (HR)|0.797||||0.232|TWO_SIDED|95.0|0.43|1.46|||Regression, Cox||95% CI was based on a Wald test from Cox model.|||1.46|0.43|0.232
72325394|NCT01120405|144174214|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority of xenon over sevoflurane is accepted if the upper bound of the two-sided 95% CI around the estimated difference is below the prespecified non-inferiority margin of 10%.|Difference of proportion|0.19||||0.0052|TWO_SIDED|95.0|-6.7|7.07|||Difference of proportion|||"The percentage of patients with MN during the 3 postoperative days in the sevoflurane group and in the xenon group was expected to be 20%. The margin of non-inferiority was 10%. Thus the sample size to prove non-inferiority was 252 patients per group with α = 0.025, a power of 0.80 and the following hypotheses: H0: Px-Pc ≥ 10%; H1: Px-Pc \< 10%.~As it was expected that approximately 15% of patients would be non-evaluable, a total of 600 patients were included."||7.07|-6.70|0.0052
72417228|NCT02130193|144345271|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.02|STANDARD_DEVIATION|0.08||0.41|TWO_SIDED|95.0|-0.19|0.13||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FVC, Day 28. Data presented are for 95% equal-tailed credible intervals|||0.13|-0.19|0.41
72325395|NCT01120405|144174215|SUPERIORITY_OR_OTHER||Difference of proportion|0.68||||0.7715|TWO_SIDED|95.0|-3.9|5.25|||Difference of proportion|||||5.25|-3.90|0.7715
72417229|NCT02130193|144345271|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.02|STANDARD_DEVIATION|0.08||0.32|TWO_SIDED|95.0|-0.19|0.13||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.02 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FVC, Day 28. Data presented are for 95% equal-tailed credible intervals|||0.13|-0.19|0.32
72608444|NCT02915835|144745426|SUPERIORITY|||||||0.75|||||||ANCOVA|||||||.75
72608445|NCT02915835|144745427|SUPERIORITY|||||||0.41|||||||ANCOVA|||||||.41
72608446|NCT02915835|144745428|SUPERIORITY|||||||0.31|||||||ANCOVA|||||||0.31
72608447|NCT02915835|144745429|SUPERIORITY|||||||0.84|||||||ANCOVA|||||||0.84
72608448|NCT02915835|144745430|SUPERIORITY|||||||0.11|||||||ANCOVA|||||||0.11
72608449|NCT02915835|144745431|SUPERIORITY|||||||0.66|||||||ANCOVA|||||||0.66
72608450|NCT02915835|144745432|SUPERIORITY|||||||0.27|||||||ANCOVA|||||||0.27
72608451|NCT02915835|144745433|SUPERIORITY|||||||0.54|||||||ANCOVA|||||||0.54
72608452|NCT02915835|144745434|SUPERIORITY|||||||0.9|||||||ANCOVA|||||||.90
72608453|NCT02915835|144745435|SUPERIORITY|||||||0.68|||||||ANCOVA|||||||.68
72325396|NCT01120405|144174216|SUPERIORITY_OR_OTHER||Difference of proportion|0.68||||0.4763|TWO_SIDED|95.0|-1.19|2.54|||Difference of proportion|||||2.54|-1.19|0.4763
72325397|NCT01120405|144174217|SUPERIORITY_OR_OTHER||Difference of proportion|-0.34||||0.6533|TWO_SIDED|95.0|-1.82|1.14|||Difference of proportion|||||1.14|-1.82|0.6533
72417230|NCT02130193|144345271|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.02|STANDARD_DEVIATION|0.08||0.24|TWO_SIDED|95.0|-0.19|0.13||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.04 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FVC, Day 28. Data presented are for 95% equal-tailed credible intervals|||0.13|-0.19|0.24
72325398|NCT01120405|144174218|SUPERIORITY_OR_OTHER||Difference of proportion|0.68||||0.1559|TWO_SIDED|95.0|-0.26|1.61|||Difference of proportion|||||1.61|-0.26|0.1559
72325399|NCT01120405|144174220|SUPERIORITY_OR_OTHER||Difference of proportion|1.69||||0.6056|TWO_SIDED|95.0|-4.74|8.13|||Difference of proportion|||||8.13|-4.74|0.6056
72325400|NCT00508482|144174243|SUPERIORITY_OR_OTHER|||||||0.238|||||||Kruskal-Wallis|||Comparison among three groups over 4 weeks of treatment||||0.238
72325401|NCT00508482|144174243|SUPERIORITY_OR_OTHER|||||||0.004|||||||Kruskal-Wallis|||Comparison among three groups at the 4th week of follow-up||||0.004
72325402|NCT00508482|144174243|SUPERIORITY_OR_OTHER|||||||0.277|||||||Least-Significant Difference|We translated the data of three groups through rank cases, so that we can use Least-Significant Difference for the comparison of any two groups.||at the 4th week of follow-up||||0.277
72325403|NCT00508482|144174243|SUPERIORITY_OR_OTHER|||||||0.001|||||||Least-Significant Difference|We translated the data of three groups through rank cases, so that we can use Least-Significant Difference for the comparison of any two groups.||at the 4th week of follow-up||||0.001
72608454|NCT02915835|144745436|SUPERIORITY|||||||0.25|||||||ANCOVA|||||||.25
72608455|NCT02915835|144745437|SUPERIORITY|||||||0.95|||||||ANCOVA|||||||.95
72608456|NCT02915835|144745438|SUPERIORITY|||||||0.38|||||||ANCOVA|||||||0.38
72608457|NCT02915835|144745439|SUPERIORITY|||||||0.82|||||||ANCOVA|||||||.82
72608458|NCT02915835|144745440|SUPERIORITY|||||||0.47|||||||ANCOVA|||||||.47
72608459|NCT02915835|144745441|SUPERIORITY|||||||0.35|||||||ANCOVA|||||||0.35
72608460|NCT02915835|144745442|SUPERIORITY|||||||0.84|||||||ANCOVA|||||||0.84
72608461|NCT02915835|144745443|SUPERIORITY|||||||0.55|||||||ANCOVA|||||||0.55
72608462|NCT02915835|144745445|SUPERIORITY|||||||0.34|||||||ANCOVA|||||||0.34
72608463|NCT02915835|144745446|SUPERIORITY|||||||0.36|||||||ANCOVA|||||||0.36
72608464|NCT02915835|144745447|SUPERIORITY|||||||0.04|||||||ANCOVA|||||||0.04
72608465|NCT02915835|144745448|SUPERIORITY|||||||0.32|||||||ANCOVA|||||||0.32
72608466|NCT02915835|144745449|SUPERIORITY|||||||0.14|||||||ANCOVA|||||||0.14
72608467|NCT02915835|144745450|SUPERIORITY|||||||0.41|||||||ANCOVA|||||||0.41
72608468|NCT02915835|144745451|SUPERIORITY|||||||0.85|||||||ANCOVA|||||||0.85
72608469|NCT02915835|144745452|SUPERIORITY|||||||0.85|||||||ANCOVA|||||||0.85
72608470|NCT02915835|144745453|SUPERIORITY|||||||0.75|||||||ANCOVA|||||||0.75
72608471|NCT02915835|144745454|SUPERIORITY|||||||0.95|||||||ANCOVA|||||||0.95
72608472|NCT02915835|144745455|SUPERIORITY|||||||0.31|||||||ANCOVA|||||||0.31
72608473|NCT02915835|144745456|SUPERIORITY|||||||0.14|||||||ANCOVA|||||||0.14
72608474|NCT02915835|144745457|SUPERIORITY|||||||0.32|||||||ANCOVA|||||||0.32
72325404|NCT00508482|144174243|SUPERIORITY_OR_OTHER|||||||0.055|||||||Least-Significant Difference|We translated the data of three groups through rank cases, so that we can use Least-Significant Difference for the comparison of any two groups.||at the 4th week of follow-up||||0.055
72608475|NCT02915835|144745458|SUPERIORITY|||||||0.47|||||||Fisher Exact|||||||0.47
72608476|NCT02915835|144745459|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.00
72608477|NCT02915835|144745460|SUPERIORITY|||||||0.73|||||||ANCOVA|||||||0.73
72608478|NCT02915835|144745461|SUPERIORITY|||||||0.32|||||||ANCOVA|||||||0.32
72325405|NCT00508482|144174243|SUPERIORITY_OR_OTHER|||||||0.001|||||||Kruskal-Wallis|||Comparison among three groups at the 12th week of follow-up||||0.001
72608479|NCT02915835|144745462|SUPERIORITY|||||||0.45|||||||ANCOVA|||||||0.45
72608480|NCT02915835|144745463|SUPERIORITY|||||||0.58|||||||ANCOVA|||||||0.58
72608481|NCT02915835|144745464|SUPERIORITY|||||||0.39|||||||ANCOVA|||||||0.39
72608482|NCT02915835|144745465|SUPERIORITY|||||||0.14|||||||ANCOVA|||||||0.14
72608483|NCT00113607|144745488|SUPERIORITY_OR_OTHER||Hazard Ratio, log|0.79||||0.019|TWO_SIDED|95.0|0.65|0.96|||Log Rank|||||0.96|0.65|0.0190
72608484|NCT00113607|144745489|SUPERIORITY_OR_OTHER||Hazard Ratio, log|0.86||||0.0835|TWO_SIDED|95.0|0.72|1.02|||Log Rank|||||1.02|0.72|0.0835
72608485|NCT00113607|144745490|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.646||||0.008|TWO_SIDED|95.0|1.144|2.367|||Fisher Exact|||||2.367|1.144|0.0080
72608486|NCT00113607|144745491|SUPERIORITY_OR_OTHER||Hazard Ratio, log|0.95||||0.8203|TWO_SIDED|95.0|0.62|1.46|||Log Rank|||||1.46|0.62|0.8203
72608487|NCT01418339|144745505|SUPERIORITY||Treatment Difference|-4.63|||=|0.0028|TWO_SIDED|95.0|-7.62|-1.63||P-value was derived from a repeated measures linear model with treatment, week, and treatment by week interaction as fixed categorical effects, the baseline value as a fixed covariate, and week as the time variable for repeated measures.|MMRM|||The statistical comparison was performed using MMRM model at a significance level of 0.05 (2-sided).||-1.63|-7.62|=0.0028
72608488|NCT01418339|144745506|SUPERIORITY||Treatment Difference|-0.52|||=|0.0124|TWO_SIDED|95.0|-0.93|-0.12||P-value was derived from a repeated measures linear model with treatment, week, and treatment by week interaction as fixed categorical effects, the baseline value as a fixed covariate, and week as the time variable for repeated measures.|MMRM|||The statistical comparison was performed using MMRM model at a significance level of 0.05 (2-sided).||-0.12|-0.93|=0.0124
72608489|NCT01418339|144745507|SUPERIORITY||Treatment Difference|-2.0|||=|0.5317|TWO_SIDED|95.0|-8.31|4.32||P-value was derived from a repeated measures linear model with treatment, week, and treatment by week interaction as fixed categorical effects, the baseline value as a fixed covariate, and week as the time variable for repeated measures.|MMRM|||The statistical comparison was performed using MMRM model at a significance level of 0.05 (2-sided).||4.32|-8.31|=0.5317
72608490|NCT03093181|144745592|SUPERIORITY||Least square (LS) mean difference|3.12||||0.0128|TWO_SIDED|95.0|0.68|5.56||From Analysis of covariance (ANCOVA) with treatment main effect, age stratum and baseline as covariates|ANCOVA||Difference is first named treatment (test product) minus second named treatment (negative control) such that a positive value favors the first named treatment (test product).|||5.56|0.68|0.0128
72325406|NCT00508482|144174243|SUPERIORITY_OR_OTHER|||||||0.33|||||||Least-Significant Difference|We translated the data of three groups through rank cases, so that we can use Least-Significant Difference for the comparison of any two groups.||at the 12th week of follow-up||||0.330
72325407|NCT00508482|144174243|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Least-Significant Difference|We translated the data of three groups through rank cases, so that we can use Least-Significant Difference for the comparison of any two groups.||at the 12th week of follow-up||||<0.001
72608491|NCT03093181|144745592|SUPERIORITY||LS mean difference|1.51||||0.2262|TWO_SIDED|95.0|-0.95|3.96||From ANCOVA with treatment main effect, age stratum and baseline as covariates.|ANCOVA||Difference is first named treatment (test product) minus second named treatment (negative control) such that a positive value favors the first named treatment (test product).|||3.96|-0.95|0.2262
72608492|NCT03093181|144745594|SUPERIORITY||Odds Ratio (OR)|1.85||||0.0243|TWO_SIDED|95.0|1.08|3.15|||Odds Ratio|||Analysis of Lay Person Assessment Polarised Image.||3.15|1.08|0.0243
72608493|NCT03093181|144745594|SUPERIORITY||Odds Ratio (OR)|1.04||||0.8931|TWO_SIDED|95.0|0.61|1.78|||Odds Ratio|||Analysis of Lay Person Assessment Polarised Image.||1.78|0.61|0.8931
72608494|NCT03093181|144745594|SUPERIORITY||Odds Ratio (OR)|1.9||||0.0181|TWO_SIDED|95.0|1.12|3.25|||Odds Ratio|||Analysis of Lay Person Assessment Non-Polarised Image.||3.25|1.12|0.0181
72608495|NCT03093181|144745594|SUPERIORITY||Odds Ratio (OR)|0.94||||0.8319|TWO_SIDED|95.0|0.55|1.63|||Odds Ratio|||Analysis of Lay Person Assessment Non-Polarised Image.||1.63|0.55|0.8319
72608496|NCT03093181|144745595|SUPERIORITY||Mean Difference (Final Values)|0.15||||0.0279|TWO_SIDED|95.0|0.02|0.28|||ANOVA|ANOVA= average rate over all raters including effects of treatment and age stratum.||Analysis of Lay Person Assessment Polarised Image.||0.28|0.02|0.0279
72608497|NCT03093181|144745595|SUPERIORITY||Mean Difference (Final Values)|0.01||||0.8887|TWO_SIDED|95.0|-0.12|0.14|||ANOVA|ANOVA= average rate over all raters including effects of treatment and age stratum.||Analysis of Lay Person Assessment Polarised Image.||0.14|-0.12|0.8887
72608498|NCT03093181|144745595|SUPERIORITY||Mean Difference (Final Values)|0.15||||0.0224|TWO_SIDED|95.0|0.02|0.28|||ANOVA|ANOVA= average rate over all raters including effects of treatment and age stratum.||Analysis of Lay Person Assessment Non-Polarised Image.||0.28|0.02|0.0224
72608499|NCT03093181|144745595|SUPERIORITY||Mean Difference (Final Values)|-0.01||||0.8253|TWO_SIDED|95.0|-0.15|0.12|||ANOVA|ANOVA= average rate over all raters including effects of treatment and age stratum.||Analysis of Lay Person Assessment Non-Polarised Image.||0.12|-0.15|0.8253
72608500|NCT04210986|144745599|SUPERIORITY||Odds Ratio (OR)|0.99|||>|0.9|TWO_SIDED|95.0|0.25|4.02||No adjustment made for multiple comparisons.|Fisher Exact||Odds ratio is for fisetin group, relative to the placebo group.|Null hypothesis: no difference in proportion of participants experiencing any TEAE between Fisetin and Placebo groups.||4.02|0.25|>0.9
72417231|NCT02130193|144345271|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.02|STANDARD_DEVIATION|0.08||0.16|TWO_SIDED|95.0|-0.19|0.13||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.06 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FVC, Day 28. Data presented are for 95% equal-tailed credible intervals|||0.13|-0.19|0.16
72608501|NCT04210986|144745600|SUPERIORITY||Contrast of LS Means|-3.5||||0.9728|TWO_SIDED|95.0|-10.6|3.6||A priori threshold for statistical significance = 0.05. P-values adjusted for the number of post-intervention assessments via Holm-Bonferroni method.|Mixed Models Analysis|Mixed model for repeated measures (mmrm). Baseline measurement included as covariate. Random intercept and slope. Kenward-Roger DF.|Direction of Estimation Parameter: Placebo - Fisetin|DAY 14 ASSESSMENT Null hypothesis: no difference in baseline-adjusted least squares means between Fisetin and Placebo groups at each post-intervention assessment.||3.6|-10.6|0.9728
72608502|NCT04210986|144745600|SUPERIORITY||Contrast of LS Means|-2.5||||0.9728|TWO_SIDED|95.0|-7.8|2.8||A priori threshold for statistical significance = 0.05. P-values adjusted for the number of post-intervention assessments via Holm-Bonferroni method.|Mixed Models Analysis|Mixed model for repeated measures (mmrm). Baseline measurement included as covariate. Random intercept and slope. Kenward-Roger DF.|Direction of Estimation Parameter: Placebo - Fisetin|DAY 45 ASSESSMENT. Null hypothesis: no difference in baseline-adjusted least squares means between Fisetin and Placebo groups at each post-intervention assessment.||2.8|-7.8|0.9728
72608503|NCT04210986|144745600|SUPERIORITY||Contrast of LS Means|-20.5||||0.0829|TWO_SIDED|95.0|-37.7|-3.3||A priori threshold for statistical significance = 0.05. P-values adjusted for the number of post-intervention assessments via Holm-Bonferroni method.|Mixed Models Analysis|Mixed model for repeated measures (mmrm). Baseline measurement included as covariate. Random intercept and slope. Kenward-Roger DF.|Direction of Estimation Parameter: Placebo - Fisetin|MONTH 6 ASSESSMENT. Null hypothesis: no difference in baseline-adjusted least squares means between Fisetin and Placebo groups at each post-intervention assessment.||-3.3|-37.7|0.0829
72608504|NCT04210986|144745600|SUPERIORITY||Contrast of LS Means|-0.5||||0.9728|TWO_SIDED|95.0||||A priori threshold for statistical significance = 0.05. P-values adjusted for the number of post-intervention assessments via Holm-Bonferroni method.|Contrast of LS Means|Mixed model for repeated measures (mmrm). Baseline measurement included as covariate. Random intercept and slope. Kenward-Roger DF.|Direction of Estimation Parameter: Placebo - Fisetin|MONTH 12 ASSESSMENT. Null hypothesis: no difference in baseline-adjusted least squares means between Fisetin and Placebo groups at each post-intervention assessment.||||0.9728
72608505|NCT04210986|144745601|SUPERIORITY||Contrast of LS Means|2.52|||>|0.99|TWO_SIDED|95.0|-49.4|54.5||A priori threshold for statistical significance = 0.05. P-values adjusted for the number of post-intervention assessments via Holm-Bonferroni method.|Mixed Models Analysis|Mixed model for repeated measures (mmrm). Baseline measurement included as covariate. Random intercept and slope. Kenward-Roger DF.|Direction of Estimation Parameter: Placebo - Fisetin|DAY 14 ASSESSMENT. Null hypothesis: no difference in baseline-adjusted least squares means between Fisetin and Placebo groups at each post-intervention assessment.||54.5|-49.4|>0.99
72608506|NCT04210986|144745601|SUPERIORITY||Contrast of LS Means|11.0|||>|0.99|TWO_SIDED|95.0|-36.8|58.8||A priori threshold for statistical significance = 0.05. P-values adjusted for the number of post-intervention assessments via Holm-Bonferroni method.|Mixed Models Analysis|Mixed model for repeated measures (mmrm). Baseline measurement included as covariate. Random intercept and slope. Kenward-Roger DF.|Direction of Estimation Parameter: Placebo - Fisetin|DAY 45 ASSESSMENT. Null hypothesis: no difference in baseline-adjusted least squares means between Fisetin and Placebo groups at each post-intervention assessment.||58.8|-36.8|>0.99
72608507|NCT04210986|144745601|SUPERIORITY||Contrast of LS Means|-40.3||||0.6594|TWO_SIDED|95.0|-97.6|17.1||A priori threshold for statistical significance = 0.05. P-values adjusted for the number of post-intervention assessments via Holm-Bonferroni method.|Mixed Models Analysis|Mixed model for repeated measures (mmrm). Baseline measurement included as covariate. Random intercept and slope. Kenward-Roger DF.|Direction of Estimation Parameter: Placebo - Fisetin|MONTH 6 ASSESSMENT. Null hypothesis: no difference in baseline-adjusted least squares means between Fisetin and Placebo groups at each post-intervention assessment.||17.1|-97.6|0.6594
72608508|NCT04210986|144745601|SUPERIORITY||Contrast of LS Means|-6.9|||>|0.99|TWO_SIDED|95.0|-45.5|31.7||A priori threshold for statistical significance = 0.05. P-values adjusted for the number of post-intervention assessments via Holm-Bonferroni method.|Mixed Models Analysis|Mixed model for repeated measures (mmrm). Baseline measurement included as covariate. Random intercept and slope. Kenward-Roger DF.|Direction of Estimation Parameter: Placebo - Fisetin|MONTH 12 ASSESSMENT. Null hypothesis: no difference in baseline-adjusted least squares means between Fisetin and Placebo groups at each post-intervention assessment.||31.7|-45.5|>0.99
72608509|NCT04210986|144745602|SUPERIORITY||Contrast of LS Means|10.5||||0.748|TWO_SIDED|95.0|-12.9|33.9||A priori threshold for statistical significance = 0.05. P-values adjusted for the number of post-intervention assessments via Holm-Bonferroni method.|Mixed Models Analysis|Mixed model for repeated measures (mmrm). Baseline measurement included as covariate. Random intercept and slope. Kenward-Roger DF.|Direction of Estimation Parameter: Placebo - Fisetin|MONTH 6 ASSESSMENT. Null hypothesis: no difference in baseline-adjusted least squares means between Fisetin and Placebo groups at each post-intervention assessment.||33.9|-12.9|0.7480
72417232|NCT02130193|144345271|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.02|STANDARD_DEVIATION|0.08||0.11|TWO_SIDED|95.0|-0.19|0.13||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.08 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FVC, Day 28. Data presented are for 95% equal-tailed credible intervals|||0.13|-0.19|0.11
72608510|NCT04210986|144745602|SUPERIORITY||Contrast of LS Means|-0.6||||0.9572|TWO_SIDED|95.0|-22.2|21.1||A priori threshold for statistical significance = 0.05. P-values adjusted for the number of post-intervention assessments via Holm-Bonferroni method.|Mixed Models Analysis|Mixed model for repeated measures (mmrm). Baseline measurement included as covariate. Random intercept and slope. Kenward-Roger DF.|Direction of Estimation Parameter: Placebo - Fisetin|MONTH 12 ASSESSMENT. Null hypothesis: no difference in baseline-adjusted least squares means between Fisetin and Placebo groups at each post-intervention assessment.||21.1|-22.2|0.9572
72608511|NCT04210986|144745603|SUPERIORITY||Contrast of LS Means|0.01|||>|0.99|TWO_SIDED|95.0|-0.47|0.49||A priori threshold for statistical significance = 0.05. P-values adjusted for the number of post-intervention assessments via Holm-Bonferroni method.|Mixed Models Analysis|Mixed model for repeated measures (mmrm). Baseline measurement included as covariate. Random intercept and slope. Kenward-Roger DF.|Direction of Estimation Parameter: Placebo - Fisetin|MONTH 6 ASSESSMENT. Null hypothesis: no difference in baseline-adjusted least squares means between Fisetin and Placebo groups at each post-intervention assessment.||0.49|-0.47|>0.99
72608512|NCT04210986|144745603|SUPERIORITY||Contrast of LS Means|0.07|||>|0.99|TWO_SIDED|95.0|-0.33|0.47||A priori threshold for statistical significance = 0.05. P-values adjusted for the number of post-intervention assessments via Holm-Bonferroni method.|Mixed Models Analysis|Mixed model for repeated measures (mmrm). Baseline measurement included as covariate. Random intercept and slope. Kenward-Roger DF.|Direction of Estimation Parameter: Placebo - Fisetin|MONTH 12 ASSESSMENT. Null hypothesis: no difference in baseline-adjusted least squares means between Fisetin and Placebo groups at each post-intervention assessment.||0.47|-0.33|>0.99
72608513|NCT04210986|144745604|SUPERIORITY||Contrast of LS Means|-0.37|||>|0.99|TWO_SIDED|95.0|-1.61|0.87||A priori threshold for statistical significance = 0.05. P-values adjusted for the number of post-intervention assessments via Holm-Bonferroni method.|Mixed Models Analysis|Mixed model for repeated measures (mmrm). Baseline measurement included as covariate. Random intercept and slope. Kenward-Roger DF.|Direction of Estimation Parameter: Placebo - Fisetin|MONTH 6 ASSESSMENT. Null hypothesis: no difference in baseline-adjusted least squares means between Fisetin and Placebo groups at each post-intervention assessment.||0.87|-1.61|>0.99
72608514|NCT04210986|144745604|SUPERIORITY||Contrast of LS Means|0.16|||>|0.99|TWO_SIDED|95.0|-0.8|1.13||A priori threshold for statistical significance = 0.05. P-values adjusted for the number of post-intervention assessments via Holm-Bonferroni method.|Mixed Models Analysis|Mixed model for repeated measures (mmrm). Baseline measurement included as covariate. Random intercept and slope. Kenward-Roger DF.|Direction of Estimation Parameter: Placebo - Fisetin|MONTH 12 ASSESSMENT. Null hypothesis: no difference in baseline-adjusted least squares means between Fisetin and Placebo groups at each post-intervention assessment.||1.13|-0.80|>0.99
72608515|NCT04210986|144745605|SUPERIORITY||Contrast of LS Means|-0.022||||0.13|TWO_SIDED|95.0|-0.045|0.002||A priori threshold for statistical significance = 0.05. P-values adjusted for the number of post-intervention assessments via Holm-Bonferroni method.|Mixed Models Analysis|Mixed model for repeated measures (mmrm). Baseline measurement included as covariate. Random intercept and slope. Kenward-Roger DF.|Direction of Estimation Parameter: Placebo - Fisetin|MONTH 6 ASSESSMENT. Null hypothesis: no difference in baseline-adjusted least squares means between Fisetin and Placebo groups at each post-intervention assessment.||0.002|-0.045|0.130
72608516|NCT04210986|144745605|SUPERIORITY||Contrast of LS Means|-0.024||||0.13|TWO_SIDED|95.0|-0.049|0.002||A priori threshold for statistical significance = 0.05. P-values adjusted for the number of post-intervention assessments via Holm-Bonferroni method.|Mixed Models Analysis|Mixed model for repeated measures (mmrm). Baseline measurement included as covariate. Random intercept and slope. Kenward-Roger DF.|Direction of Estimation Parameter: Placebo - Fisetin|MONTH 12 ASSESSMENT. Null hypothesis: no difference in baseline-adjusted least squares means between Fisetin and Placebo groups at each post-intervention assessment.||0.002|-0.049|0.130
72608517|NCT04210986|144745606|SUPERIORITY||Contrast of LS Means|-0.22||||0.9584|TWO_SIDED|95.0|-0.84|0.4||A priori threshold for statistical significance = 0.05. P-values adjusted for the number of post-intervention assessments via Holm-Bonferroni method.|Mixed Models Analysis|Mixed model for repeated measures (mmrm). Baseline measurement included as covariate. Random intercept and slope. Kenward-Roger DF.|Direction of Estimation Parameter: Placebo - Fisetin|MONTH 6 ASSESSMENT. Null hypothesis: no difference in baseline-adjusted least squares means between Fisetin and Placebo groups at each post-intervention assessment.||0.40|-0.84|0.9584
72608518|NCT04210986|144745606|SUPERIORITY||Contrast of LS Means|0.12||||0.9584|TWO_SIDED|95.0|-0.69|0.92||A priori threshold for statistical significance = 0.05. P-values adjusted for the number of post-intervention assessments via Holm-Bonferroni method.|Mixed Models Analysis|Mixed model for repeated measures (mmrm). Baseline measurement included as covariate. Random intercept and slope. Kenward-Roger DF.|Direction of Estimation Parameter: Placebo - Fisetin|MONTH 12 ASSESSMENT. Null hypothesis: no difference in baseline-adjusted least squares means between Fisetin and Placebo groups at each post-intervention assessment.||0.92|-0.69|0.9584
72417233|NCT02130193|144345271|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.02|STANDARD_DEVIATION|0.08||0.07|TWO_SIDED|95.0|-0.19|0.13||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.10 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FVC, Day 28. Data presented are for 95% equal-tailed credible intervals|||0.13|-0.19|0.07
72417234|NCT02130193|144345271|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.02|STANDARD_DEVIATION|0.09||0.41|TWO_SIDED|95.0|-0.2|0.15||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FVC, Day 56. Data presented are for 95% equal-tailed credible intervals|||0.15|-0.20|0.41
72417235|NCT02130193|144345271|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.02|STANDARD_DEVIATION|0.09||0.32|TWO_SIDED|95.0|-0.2|0.15||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.02 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FVC, Day 56. Data presented are for 95% equal-tailed credible intervals|||0.15|-0.20|0.32
72417236|NCT02130193|144345271|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.02|STANDARD_DEVIATION|0.09||0.25|TWO_SIDED|95.0|-0.2|0.15||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.04 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FVC, Day 56. Data presented are for 95% equal-tailed credible intervals|||0.15|-0.20|0.25
72417237|NCT02130193|144345271|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.02|STANDARD_DEVIATION|0.09||0.18|TWO_SIDED|95.0|-0.2|0.15||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.06 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FVC, Day 56. Data presented are for 95% equal-tailed credible intervals|||0.15|-0.20|0.18
72417238|NCT02130193|144345271|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.02|STANDARD_DEVIATION|0.09||0.12|TWO_SIDED|95.0|-0.2|0.15||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.08 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FVC, Day 56. Data presented are for 95% equal-tailed credible intervals|||0.15|-0.20|0.12
72417239|NCT02130193|144345271|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.02|STANDARD_DEVIATION|0.09||0.07|TWO_SIDED|95.0|-0.2|0.15||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.10 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FVC, Day 56. Data presented are for 95% equal-tailed credible intervals|||0.15|-0.20|0.07
72417240|NCT02130193|144345271|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.01|STANDARD_DEVIATION|0.1||0.45|TWO_SIDED|95.0|-0.2|0.17||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FVC, Day 112. Data presented are for 95% equal-tailed credible intervals|||0.17|-0.20|0.45
72417241|NCT02130193|144345271|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.01|STANDARD_DEVIATION|0.1||0.37|TWO_SIDED|95.0|-0.2|0.17||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.02 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FVC, Day 112. Data presented are for 95% equal-tailed credible intervals|||0.17|-0.20|0.37
72417242|NCT02130193|144345271|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.01|STANDARD_DEVIATION|0.1||0.3|TWO_SIDED|95.0|-0.2|0.17||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.04 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FVC, Day 112. Data presented are for 95% equal-tailed credible intervals|||0.17|-0.20|0.30
72608519|NCT04210986|144745607|SUPERIORITY||Contrast of LS Means|1.88||||0.5905|TWO_SIDED|95.0|-5.07|8.84||A priori threshold for statistical significance = 0.05. P-values adjusted for the number of post-intervention assessments via Holm-Bonferroni method.|Mixed Models Analysis|Mixed model for repeated measures (mmrm). Baseline measurement included as covariate. Random intercept and slope. Kenward-Roger DF.|Direction of Estimation Parameter: Placebo - Fisetin|MONTH 6 ASSESSMENT. Null hypothesis: no difference in baseline-adjusted least squares means between Fisetin and Placebo groups at each post-intervention assessment.||8.84|-5.07|0.5905
72325408|NCT00508482|144174243|SUPERIORITY_OR_OTHER|||||||0.018|||||||Least-Significant Difference|We translated the data of three groups through rank cases, so that we can use Least-Significant Difference for the comparison of any two groups.||at the 12th week of follow-up||||0.018
72417243|NCT02130193|144345271|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.01|STANDARD_DEVIATION|0.1||0.22|TWO_SIDED|95.0|-0.2|0.17||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.06 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FVC, Day 112. Data presented are for 95% equal-tailed credible intervals|||0.17|-0.20|0.22
72417244|NCT02130193|144345271|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.01|STANDARD_DEVIATION|0.1||0.17|TWO_SIDED|95.0|-0.2|0.17||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.08 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FVC, Day 112. Data presented are for 95% equal-tailed credible intervals|||0.17|-0.20|0.17
72417245|NCT02130193|144345271|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.01|STANDARD_DEVIATION|0.1||0.12|TWO_SIDED|95.0|-0.2|0.17||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.10 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FVC, Day 112. Data presented are for 95% equal-tailed credible intervals|||0.17|-0.20|0.12
72417246|NCT02130193|144345271|SUPERIORITY_OR_OTHER||Posterior mean difference|0.05|STANDARD_DEVIATION|0.09||0.72|TWO_SIDED|95.0|-0.13|0.24||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FVC, Day 168. Data presented are for 95% equal-tailed credible intervals|||0.24|-0.13|0.72
72417247|NCT02130193|144345271|SUPERIORITY_OR_OTHER||Posterior mean difference|0.05|STANDARD_DEVIATION|0.09||0.65|TWO_SIDED|95.0|-0.13|0.24||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.02 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FVC, Day 168. Data presented are for 95% equal-tailed credible intervals|||0.24|-0.13|0.65
72417248|NCT02130193|144345271|SUPERIORITY_OR_OTHER||Posterior mean difference|0.05|STANDARD_DEVIATION|0.09||0.57|TWO_SIDED|95.0|-0.13|0.24||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.04 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FVC, Day 168. Data presented are for 95% equal-tailed credible intervals|||0.24|-0.13|0.57
72417249|NCT02130193|144345271|SUPERIORITY_OR_OTHER||Posterior mean difference|0.05|STANDARD_DEVIATION|0.09||0.48|TWO_SIDED|95.0|-0.13|0.24||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.06 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FVC, Day 168. Data presented are for 95% equal-tailed credible intervals|||0.24|-0.13|0.48
72325409|NCT00508482|144174244|SUPERIORITY_OR_OTHER|||||||0.573|||||||ANOVA|||||||0.573
72325410|NCT00508482|144174245|SUPERIORITY_OR_OTHER|||||||0.271|||||||Kruskal-Wallis|||||||0.271
72325411|NCT00508482|144174246|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA|||||||<0.001
72325412|NCT00508482|144174246|SUPERIORITY_OR_OTHER|||||||0.58|||||||Least-Significant Difference|||||||0.580
72417250|NCT02130193|144345271|SUPERIORITY_OR_OTHER||Posterior mean difference|0.05|STANDARD_DEVIATION|0.09||0.39|TWO_SIDED|95.0|-0.13|0.24||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.08 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FVC, Day 168. Data presented are for 95% equal-tailed credible intervals|||0.24|-0.13|0.39
72417251|NCT02130193|144345271|SUPERIORITY_OR_OTHER||Posterior mean difference|0.05|STANDARD_DEVIATION|0.09||0.3|TWO_SIDED|95.0|-0.13|0.24||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.10 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FVC, Day 168. Data presented are for 95% equal-tailed credible intervals|||0.24|-0.13|0.30
72608520|NCT04210986|144745607|SUPERIORITY||Contrast of LS Means|3.86||||0.5414|TWO_SIDED|95.0|-3.08|10.79||A priori threshold for statistical significance = 0.05. P-values adjusted for the number of post-intervention assessments via Holm-Bonferroni method.|Mixed Models Analysis|Mixed model for repeated measures (mmrm). Baseline measurement included as covariate. Random intercept and slope. Kenward-Roger DF.|Direction of Estimation Parameter: Placebo - Fisetin|MONTH 12 ASSESSMENT. Null hypothesis: no difference in baseline-adjusted least squares means between Fisetin and Placebo groups at each post-intervention assessment.||10.79|-3.08|0.5414
72608521|NCT04210986|144745608|SUPERIORITY||Contrast of LS Means|0.05|||>|0.99|TWO_SIDED|95.0|-0.75|0.85||A priori threshold for statistical significance = 0.05. P-values adjusted for the number of post-intervention assessments via Holm-Bonferroni method.|Mixed Models Analysis|Mixed model for repeated measures (mmrm). Baseline measurement included as covariate. Random intercept and slope. Kenward-Roger DF.|Direction of Estimation Parameter: Placebo - Fisetin|DAY 3 ASSESSMENT. Null hypothesis: no difference in baseline-adjusted least squares means between Fisetin and Placebo groups at each post-intervention assessment.||0.85|-0.75|>0.99
72608522|NCT04210986|144745608|SUPERIORITY||Contrast of LS Means|0.44|||>|0.99|TWO_SIDED|95.0|-0.45|1.34||A priori threshold for statistical significance = 0.05. P-values adjusted for the number of post-intervention assessments via Holm-Bonferroni method.|Mixed Models Analysis|Mixed model for repeated measures (mmrm). Baseline measurement included as covariate. Random intercept and slope. Kenward-Roger DF.|Direction of Estimation Parameter: Placebo - Fisetin|DAY 6 ASSESSMENT. Null hypothesis: no difference in baseline-adjusted least squares means between Fisetin and Placebo groups at each post-intervention assessment.||1.34|-0.45|>0.99
72608523|NCT04210986|144745608|SUPERIORITY||Contrast of LS Means|0.42|||>|0.99|TWO_SIDED|95.0|-0.7|1.54||A priori threshold for statistical significance = 0.05. P-values adjusted for the number of post-intervention assessments via Holm-Bonferroni method.|Mixed Models Analysis|Mixed model for repeated measures (mmrm). Baseline measurement included as covariate. Random intercept and slope. Kenward-Roger DF.|Direction of Estimation Parameter: Placebo - Fisetin|DAY 9 ASSESSMENT. Null hypothesis: no difference in baseline-adjusted least squares means between Fisetin and Placebo groups at each post-intervention assessment.||1.54|-0.70|>0.99
72608524|NCT04210986|144745608|SUPERIORITY||Contrast of LS Means|-0.06|||>|0.99|TWO_SIDED|95.0|-0.91|0.78||A priori threshold for statistical significance = 0.05. P-values adjusted for the number of post-intervention assessments via Holm-Bonferroni method.|Mixed Models Analysis|Mixed model for repeated measures (mmrm). Baseline measurement included as covariate. Random intercept and slope. Kenward-Roger DF.|Direction of Estimation Parameter: Placebo - Fisetin|DAY 12 ASSESSMENT. Null hypothesis: no difference in baseline-adjusted least squares means between Fisetin and Placebo groups at each post-intervention assessment.||0.78|-0.91|>0.99
72608525|NCT04210986|144745608|SUPERIORITY||Contrast of LS Means|-0.47|||>|0.99|TWO_SIDED|95.0|-1.5|0.56||A priori threshold for statistical significance = 0.05. P-values adjusted for the number of post-intervention assessments via Holm-Bonferroni method.|Mixed Models Analysis|Mixed model for repeated measures (mmrm). Baseline measurement included as covariate. Random intercept and slope. Kenward-Roger DF.|Direction of Estimation Parameter: Placebo - Fisetin|DAY 15 ASSESSMENT. Null hypothesis: no difference in baseline-adjusted least squares means between Fisetin and Placebo groups at each post-intervention assessment.||0.56|-1.50|>0.99
72608526|NCT04210986|144745608|SUPERIORITY||Contrast of LS Means|-0.19|||>|0.99|TWO_SIDED|95.0|-1.16|0.77||A priori threshold for statistical significance = 0.05. P-values adjusted for the number of post-intervention assessments via Holm-Bonferroni method.|Mixed Models Analysis|Mixed model for repeated measures (mmrm). Baseline measurement included as covariate. Random intercept and slope. Kenward-Roger DF.|Direction of Estimation Parameter: Placebo - Fisetin|DAY 18 ASSESSMENT. Null hypothesis: no difference in baseline-adjusted least squares means between Fisetin and Placebo groups at each post-intervention assessment.||0.77|-1.16|>0.99
72608527|NCT04210986|144745608|SUPERIORITY||Contrast of LS Means|0.19|||>|0.99|TWO_SIDED|95.0|-0.58|0.96||A priori threshold for statistical significance = 0.05. P-values adjusted for the number of post-intervention assessments via Holm-Bonferroni method.|Mixed Models Analysis|Mixed model for repeated measures (mmrm). Baseline measurement included as covariate. Random intercept and slope. Kenward-Roger DF.|Direction of Estimation Parameter: Placebo - Fisetin|DAY 21 ASSESSMENT. Null hypothesis: no difference in baseline-adjusted least squares means between Fisetin and Placebo groups at each post-intervention assessment.||0.96|-0.58|>0.99
72608528|NCT04210986|144745608|SUPERIORITY||Contrast of LS Means|0.1|||>|0.99|TWO_SIDED|95.0|-0.76|0.97||A priori threshold for statistical significance = 0.05. P-values adjusted for the number of post-intervention assessments via Holm-Bonferroni method.|Mixed Models Analysis|Mixed model for repeated measures (mmrm). Baseline measurement included as covariate. Random intercept and slope. Kenward-Roger DF.|Direction of Estimation Parameter: Placebo - Fisetin|DAY 24 ASSESSMENT. Null hypothesis: no difference in baseline-adjusted least squares means between Fisetin and Placebo groups at each post-intervention assessment.||0.97|-0.76|>0.99
72608529|NCT04210986|144745608|SUPERIORITY||Contrast of LS Means|0.01|||>|0.99|TWO_SIDED|95.0|-0.74|0.76||A priori threshold for statistical significance = 0.05. P-values adjusted for the number of post-intervention assessments via Holm-Bonferroni method.|Mixed Models Analysis|Mixed model for repeated measures (mmrm). Baseline measurement included as covariate. Random intercept and slope. Kenward-Roger DF.|Direction of Estimation Parameter: Placebo - Fisetin|DAY 27 ASSESSMENT. Null hypothesis: no difference in baseline-adjusted least squares means between Fisetin and Placebo groups at each post-intervention assessment.||0.76|-0.74|>0.99
72608530|NCT04210986|144745608|SUPERIORITY||Contrast of LS Means|-0.38|||>|0.99|TWO_SIDED|95.0|-1.2|0.44||A priori threshold for statistical significance = 0.05. P-values adjusted for the number of post-intervention assessments via Holm-Bonferroni method.|Mixed Models Analysis|Mixed model for repeated measures (mmrm). Baseline measurement included as covariate. Random intercept and slope. Kenward-Roger DF.|Direction of Estimation Parameter: Placebo - Fisetin|DAY 30 ASSESSMENT. Null hypothesis: no difference in baseline-adjusted least squares means between Fisetin and Placebo groups at each post-intervention assessment.||0.44|-1.20|>0.99
72608531|NCT04210986|144745608|SUPERIORITY||Contrast of LS Means|0.1|||>|0.99|TWO_SIDED|95.0|-0.69|0.89||A priori threshold for statistical significance = 0.05. P-values adjusted for the number of post-intervention assessments via Holm-Bonferroni method.|Mixed Models Analysis|Mixed model for repeated measures (mmrm). Baseline measurement included as covariate. Random intercept and slope. Kenward-Roger DF.|Direction of Estimation Parameter: Placebo - Fisetin|DAY 33 ASSESSMENT. Null hypothesis: no difference in baseline-adjusted least squares means between Fisetin and Placebo groups at each post-intervention assessment.||0.89|-0.69|>0.99
72608532|NCT04210986|144745608|SUPERIORITY||Contrast of LS Means|-0.2|||>|0.99|TWO_SIDED|95.0|-1.02|0.61||A priori threshold for statistical significance = 0.05. P-values adjusted for the number of post-intervention assessments via Holm-Bonferroni method.|Mixed Models Analysis|Mixed model for repeated measures (mmrm). Baseline measurement included as covariate. Random intercept and slope. Kenward-Roger DF.|Direction of Estimation Parameter: Placebo - Fisetin|DAY 36 ASSESSMENT. Null hypothesis: no difference in baseline-adjusted least squares means between Fisetin and Placebo groups at each post-intervention assessment.||0.61|-1.02|>0.99
72608533|NCT04210986|144745608|SUPERIORITY||Contrast of LS Means|0.11|||>|0.99|TWO_SIDED|95.0|-0.7|0.92||A priori threshold for statistical significance = 0.05. P-values adjusted for the number of post-intervention assessments via Holm-Bonferroni method.|Mixed Models Analysis|Mixed model for repeated measures (mmrm). Baseline measurement included as covariate. Random intercept and slope. Kenward-Roger DF.|Direction of Estimation Parameter: Placebo - Fisetin|DAY 39 ASSESSMENT. Null hypothesis: no difference in baseline-adjusted least squares means between Fisetin and Placebo groups at each post-intervention assessment.||0.92|-0.70|>0.99
72608534|NCT04210986|144745608|SUPERIORITY||Contrast of LS Means|-0.62|||>|0.99|TWO_SIDED|95.0|-1.36|0.13||A priori threshold for statistical significance = 0.05. P-values adjusted for the number of post-intervention assessments via Holm-Bonferroni method.|Mixed Models Analysis|Mixed model for repeated measures (mmrm). Baseline measurement included as covariate. Random intercept and slope. Kenward-Roger DF.|Direction of Estimation Parameter: Placebo - Fisetin|DAY 42 ASSESSMENT. Null hypothesis: no difference in baseline-adjusted least squares means between Fisetin and Placebo groups at each post-intervention assessment.||0.13|-1.36|>0.99
72608535|NCT04210986|144745608|SUPERIORITY||Contrast of LS Means|-0.23|||>|0.99|TWO_SIDED|95.0|-1.01|0.55||A priori threshold for statistical significance = 0.05. P-values adjusted for the number of post-intervention assessments via Holm-Bonferroni method.|Mixed Models Analysis|Mixed model for repeated measures (mmrm). Baseline measurement included as covariate. Random intercept and slope. Kenward-Roger DF.|Direction of Estimation Parameter: Placebo - Fisetin|WEEK 7 ASSESSMENT. Null hypothesis: no difference in baseline-adjusted least squares means between Fisetin and Placebo groups at each post-intervention assessment.||0.55|-1.01|>0.99
72608536|NCT04210986|144745608|SUPERIORITY||Contrast of LS Means|-0.2|||>|0.99|TWO_SIDED|95.0|-0.89|0.49||A priori threshold for statistical significance = 0.05. P-values adjusted for the number of post-intervention assessments via Holm-Bonferroni method.|Mixed Models Analysis|Mixed model for repeated measures (mmrm). Baseline measurement included as covariate. Random intercept and slope. Kenward-Roger DF.|Direction of Estimation Parameter: Placebo - Fisetin|WEEK 8 ASSESSMENT. Null hypothesis: no difference in baseline-adjusted least squares means between Fisetin and Placebo groups at each post-intervention assessment.||0.49|-0.89|>0.99
72325413|NCT00508482|144174246|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Least-Significant Difference|||||||<0.001
72325414|NCT00508482|144174246|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Least-Significant Difference|||||||<0.001
72325415|NCT00508482|144174247|SUPERIORITY_OR_OTHER|||||||0.167|||||||ANOVA|||||||0.167
72325416|NCT00508482|144174248|SUPERIORITY_OR_OTHER|||||||0.066|||||||Kruskal-Wallis|||||||0.066
72417252|NCT02130193|144345271|SUPERIORITY_OR_OTHER||Posterior mean difference|0.09|STANDARD_DEVIATION|0.12||0.76|TWO_SIDED|95.0|-0.15|0.32||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FVC, Day 280. Data presented are for 95% equal-tailed credible intervals|||0.32|-0.15|0.76
72417253|NCT02130193|144345271|SUPERIORITY_OR_OTHER||Posterior mean difference|0.09|STANDARD_DEVIATION|0.12||0.71|TWO_SIDED|95.0|-0.15|0.32||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.02 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FVC, Day 280. Data presented are for 95% equal-tailed credible intervals|||0.32|-0.15|0.71
72417254|NCT02130193|144345271|SUPERIORITY_OR_OTHER||Posterior mean difference|0.09|STANDARD_DEVIATION|0.12||0.65|TWO_SIDED|95.0|-0.15|0.32||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.04 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FVC, Day 280. Data presented are for 95% equal-tailed credible intervals|||0.32|-0.15|0.65
72417255|NCT02130193|144345271|SUPERIORITY_OR_OTHER||Posterior mean difference|0.09|STANDARD_DEVIATION|0.12||0.59|TWO_SIDED|95.0|-0.15|0.32||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.06 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FVC, Day 280. Data presented are for 95% equal-tailed credible intervals|||0.32|-0.15|0.59
72417256|NCT02130193|144345271|SUPERIORITY_OR_OTHER||Posterior mean difference|0.09|STANDARD_DEVIATION|0.12||0.53|TWO_SIDED|95.0|-0.15|0.32||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.08 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FVC, Day 280. Data presented are for 95% equal-tailed credible intervals|||0.32|-0.15|0.53
72608537|NCT04210986|144745608|SUPERIORITY||Contrast of LS Means|0.02|||>|0.99|TWO_SIDED|95.0|-0.63|0.67||A priori threshold for statistical significance = 0.05. P-values adjusted for the number of post-intervention assessments via Holm-Bonferroni method.|Mixed Models Analysis|Mixed model for repeated measures (mmrm). Baseline measurement included as covariate. Random intercept and slope. Kenward-Roger DF.|Direction of Estimation Parameter: Placebo - Fisetin|WEEK 9 ASSESSMENT. Null hypothesis: no difference in baseline-adjusted least squares means between Fisetin and Placebo groups at each post-intervention assessment.||0.67|-0.63|>0.99
72608538|NCT04210986|144745608|SUPERIORITY||Contrast of LS Means|-0.17|||>|0.99|TWO_SIDED|95.0|-0.95|0.61||A priori threshold for statistical significance = 0.05. P-values adjusted for the number of post-intervention assessments via Holm-Bonferroni method.|Mixed Models Analysis|Mixed model for repeated measures (mmrm). Baseline measurement included as covariate. Random intercept and slope. Kenward-Roger DF.|Direction of Estimation Parameter: Placebo - Fisetin|WEEK 10 ASSESSMENT. Null hypothesis: no difference in baseline-adjusted least squares means between Fisetin and Placebo groups at each post-intervention assessment.||0.61|-0.95|>0.99
72608539|NCT04210986|144745608|SUPERIORITY||Contrast of LS Means|-0.42|||>|0.99|TWO_SIDED|95.0|-1.18|0.34||A priori threshold for statistical significance = 0.05. P-values adjusted for the number of post-intervention assessments via Holm-Bonferroni method.|Mixed Models Analysis|Mixed model for repeated measures (mmrm). Baseline measurement included as covariate. Random intercept and slope. Kenward-Roger DF.|Direction of Estimation Parameter: Placebo - Fisetin|WEEK 11 ASSESSMENT. Null hypothesis: no difference in baseline-adjusted least squares means between Fisetin and Placebo groups at each post-intervention assessment.||0.34|-1.18|>0.99
72608540|NCT04210986|144745608|SUPERIORITY||Contrast of LS Means|-0.35|||>|0.99|TWO_SIDED|95.0|-1.41|0.71||A priori threshold for statistical significance = 0.05. P-values adjusted for the number of post-intervention assessments via Holm-Bonferroni method.|Mixed Models Analysis|Mixed model for repeated measures (mmrm). Baseline measurement included as covariate. Random intercept and slope. Kenward-Roger DF.|Direction of Estimation Parameter: Placebo - Fisetin|WEEK 12 ASSESSMENT. Null hypothesis: no difference in baseline-adjusted least squares means between Fisetin and Placebo groups at each post-intervention assessment.||0.71|-1.41|>0.99
72608541|NCT04210986|144745609|SUPERIORITY||Contrast of LS Means|1.86||||0.9106|TWO_SIDED|95.0|-3.09|6.82||A priori threshold for statistical significance = 0.05. P-values adjusted for the number of post-intervention assessments via Holm-Bonferroni method.|Mixed Models Analysis|Mixed model for repeated measures (mmrm). Baseline measurement included as covariate. Random intercept and slope. Kenward-Roger DF.|Direction of Estimation Parameter: Placebo - Fisetin|MONTH 6 ASSESSMENT. Null hypothesis: no difference in baseline-adjusted least squares means between Fisetin and Placebo groups at each post-intervention assessment.||6.82|-3.09|0.9106
72417257|NCT02130193|144345271|SUPERIORITY_OR_OTHER||Posterior mean difference|0.09|STANDARD_DEVIATION|0.12||0.46|TWO_SIDED|95.0|-0.15|0.32||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.10 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FVC, Day 280. Data presented are for 95% equal-tailed credible intervals|||0.32|-0.15|0.46
72417258|NCT02130193|144345271|SUPERIORITY_OR_OTHER||Posterior mean difference|0.05|STANDARD_DEVIATION|0.11||0.68|TWO_SIDED|95.0|-0.15|0.28||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FVC, Day 364. Data presented are for 95% equal-tailed credible intervals|||0.28|-0.15|0.68
72417259|NCT02130193|144345271|SUPERIORITY_OR_OTHER||Posterior mean difference|0.05|STANDARD_DEVIATION|0.11||0.61|TWO_SIDED|95.0|-0.15|0.28||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.02 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FVC, Day 364. Data presented are for 95% equal-tailed credible intervals|||0.28|-0.15|0.61
72417260|NCT02130193|144345271|SUPERIORITY_OR_OTHER||Posterior mean difference|0.05|STANDARD_DEVIATION|0.11||0.55|TWO_SIDED|95.0|-0.15|0.28||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.04 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FVC, Day 364. Data presented are for 95% equal-tailed credible intervals|||0.28|-0.15|0.55
72325417|NCT00508482|144174249|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA|||||||<0.001
72608542|NCT04210986|144745609|SUPERIORITY||Contrast of LS Means|-4.2||||0.4424|TWO_SIDED|95.0|-9.93|1.53||A priori threshold for statistical significance = 0.05. P-values adjusted for the number of post-intervention assessments via Holm-Bonferroni method.|Mixed Models Analysis|Mixed model for repeated measures (mmrm). Baseline measurement included as covariate. Random intercept and slope. Kenward-Roger DF.|Direction of Estimation Parameter: Placebo - Fisetin|MONTH 12 ASSESSMENT. Null hypothesis: no difference in baseline-adjusted least squares means between Fisetin and Placebo groups at each post-intervention assessment.||1.53|-9.93|0.4424
72608543|NCT04210986|144745609|SUPERIORITY||Contrast of LS Means|-0.03||||0.9901|TWO_SIDED|95.0|-5.55|5.48||A priori threshold for statistical significance = 0.05. P-values adjusted for the number of post-intervention assessments via Holm-Bonferroni method.|Mixed Models Analysis|Mixed model for repeated measures (mmrm). Baseline measurement included as covariate. Random intercept and slope. Kenward-Roger DF.|Direction of Estimation Parameter: Placebo - Fisetin|MONTH 18 ASSESSMENT. Null hypothesis: no difference in baseline-adjusted least squares means between Fisetin and Placebo groups at each post-intervention assessment.||5.48|-5.55|0.9901
72608544|NCT04210986|144745610|SUPERIORITY||Contrast of LS Means|0.69|||>|0.99|TWO_SIDED|95.0|-30.95|32.3||A priori threshold for statistical significance = 0.05. P-values adjusted for the number of post-intervention assessments via Holm-Bonferroni method.|Mixed Models Analysis|Mixed model for repeated measures (mmrm). Baseline measurement included as covariate. Random intercept and slope. Kenward-Roger DF.|Direction of Estimation Parameter: Placebo - Fisetin|"MONTH 6 ASSESSMENT. Null hypothesis: no difference in baseline-adjusted least squares means between Fisetin and Placebo groups at each post-intervention assessment.~A priori power calculation was based a standardized mean difference effect size of SMD=0.73 (Mackay, et al, 2018, Osteoarthritis and Cartilage)."||32.3|-30.95|>0.99
72608545|NCT04210986|144745610|SUPERIORITY||Contrast of LS Means|-11.3|||>|0.99|TWO_SIDED|95.0|-46.9|24.2||A priori threshold for statistical significance = 0.05. P-values adjusted for the number of post-intervention assessments via Holm-Bonferroni method.|Mixed Models Analysis|Mixed model for repeated measures (mmrm). Baseline measurement included as covariate. Random intercept and slope. Kenward-Roger DF.|Direction of Estimation Parameter: Placebo - Fisetin|"MONTH 12 ASSESSMENT. Null hypothesis: no difference in baseline-adjusted least squares means between Fisetin and Placebo groups at each post-intervention assessment.~A priori power calculation was based a standardized mean difference effect size of SMD=0.73 (Mackay, et al, 2018, Osteoarthritis and Cartilage)."||24.2|-46.9|>0.99
72608546|NCT04210986|144745611|SUPERIORITY||Hazard Ratio (HR)|0.44||||0.474|TWO_SIDED|95.0|0.05|4.21||A priori threshold for statistical significance = 0.05.|Log Rank|Cox proportional hazards model constructed. Score (log rank) test to assess between group difference in hazard rate.|Hazard ratio expresses the hazard rate of the Fisetin group in the numerator and the hazard rate of the Placebo group in the denominator|With only 4 participants that converted to an alternative treatment modality, this analysis is underpowered.||4.21|0.05|0.474
72608547|NCT02965924|144745620|SUPERIORITY||||||<|0.01|||||||t-test, 2 sided|||||||<0.01
72608548|NCT01474486|144745630|OTHER|||||||0.64|||||||Mixed Models Analysis|||||||0.64
72608549|NCT04233879|144745669|NON_INFERIORITY|Non-inferiority was concluded if the upper bound of the 2-sided multiplicity-adjusted 95% confidence interval (95%CI) was less than 10 percentage points.|Treatment Difference|0.6|||||TWO_SIDED|95.0|-4.5|5.8|||||Unstratified Miettinen and Nurminen method was used to generate the treatment difference and the associated 95%CI.|||5.8|-4.5|
72608550|NCT04233879|144745670|OTHER|Difference between treatment groups (Group 1: DOR/ISL and Group 2: BIC/FTC/TAF)|Percentage Difference|4.3|||||TWO_SIDED|95.0|-0.8|9.6|||||Miettinen \& Nurminen method was used to generate percentage difference and the associated 95%CI.|||9.6|-0.8|
72608551|NCT04233879|144745671|OTHER|Difference between treatment groups (Group 1: DOR/ISL and Group 2: BIC/FTC/TAF)|Percentage Difference|4.0|||||TWO_SIDED|95.0|0.4|7.9|||||Miettinen \& Nurminen method was used to generate percentage difference and the associated 95%CI.|||7.9|0.4|
72608552|NCT04233879|144745674|NON_INFERIORITY|Non-inferiority was concluded if the upper bound of the 2-sided multiplicity-adjusted 95% CI was less than 10 percentage points.|Treatment Difference|2.3|||||TWO_SIDED|95.0|-3.1|7.7|||||Miettinen and Nurminen method was used to generate treatment difference and the associated 95%CI.|||7.7|-3.1|
72608553|NCT04233879|144745675|NON_INFERIORITY|Non-inferiority was concluded if the upper bound of the 2-sided multiplicity-adjusted 95% CI was less than 10 percentage points.|Treatment Difference|1.0|||||TWO_SIDED|95.0|-4.1|6.1|||||Miettinen and Nurminen method was used to generate treatment difference and the associated 95%CI.|||6.1|-4.1|
72608554|NCT04233879|144745686|SUPERIORITY|Superiority will be concluded if the upper bound of the 2-sided multiplicity-adjusted 95% CI was less than 0.|Treatment Difference|0.15||||0.73|TWO_SIDED|95.0|-0.71|1.02|||ANCOVA|A 2-sided p-value was calculated using the Analysis of covariance (ANCOVA) model.|ANCOVA model was used to generate treatment difference and the associated 95%CI.|||1.02|-0.71|0.73
72608555|NCT03585270|144745697|SUPERIORITY||Relative Risk Reduction|0.072||||0.7338|TWO_SIDED|95.0|-0.426|0.396|||Cochran-Mantel-Haenszel||Homogeneity of the treatment effect across strata was investigated using the Breslow-Day test (p-value = 0.2785).|||0.396|-0.426|0.7338
72325418|NCT00508482|144174249|SUPERIORITY_OR_OTHER|||||||0.024|||||||Least-Significant Difference|||||||0.024
72325419|NCT00508482|144174249|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Least-Significant Difference|||||||<0.001
72325420|NCT00508482|144174249|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Least-Significant Difference|||||||<0.001
72608556|NCT03585270|144745698|SUPERIORITY||Relative Risk Reduction|0.341||||0.177|TWO_SIDED|95.0|-0.213|0.642|||Cochran-Mantel-Haenszel||Homogeneity of the treatment effect across strata was investigated using the Breslow-Day test (p-value = 0.8644).|||0.642|-0.213|0.177
72608557|NCT03585270|144745699|SUPERIORITY||Relative Risk Reduction|-0.254||||0.1983|TWO_SIDED|95.0|-0.76|0.107|||Cochran-Mantel-Haenszel||Homogeneity of the treatment effect across strata was investigated using the Breslow-Day test (p-value = 0.8844).|||0.107|-0.760|0.1983
72608558|NCT03585270|144745700|SUPERIORITY||Relative Risk Reduction|-0.254||||0.1983|TWO_SIDED|95.0|-0.76|0.107|||Cochran-Mantel-Haenszel||Homogeneity of the treatment effect across strata was investigated using the Breslow-Day test (p-value = 0.8844).|||0.107|-0.760|0.1983
72608559|NCT03585270|144745701|SUPERIORITY||Relative Risk Reduction|0.119||||0.5591|TWO_SIDED|95.0|-0.349|0.425|||Cochran-Mantel-Haenszel||Homogeneity of the treatment effect across strata was investigated using the Breslow-Day test (p-value = 0.1706).|||0.425|-0.349|0.5591
72608560|NCT03585270|144745702|SUPERIORITY||Relative Risk Reduction|0.267||||0.1179|TWO_SIDED|95.0|-0.085|0.505|||Cochran-Mantel-Haenszel||Homogeneity of the treatment effect across strata was investigated using the Breslow-Day test (p-value = 0.4580)|||0.505|-0.085|0.1179
72608561|NCT03585270|144745703|SUPERIORITY||Relative Risk Reduction|0.139||||0.5217|TWO_SIDED|95.0|-0.365|0.457|||Cochran-Mantel-Haenszel||Homogeneity of the treatment effect across strata was investigated using the Breslow-Day test (p-value = 0.1685)|||0.457|-0.365|0.5217
72325421|NCT00508482|144174250|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Chi-squared|||||||<0.001
72608562|NCT03292016|144745704|OTHER||Geometric Mean ratio (APL-130277/APOKYN)|12.3|||||TWO_SIDED|90.0|7.5|20.3|||Mixed Models Analysis|With fixed effects-treatment and period, random effect-subject nested within sequence to analyze natural-log transformed dose normalized parameter.||Sample size of 12 subjects, a two-sided 90% CI for the difference in paired PK parameter means on the log scale will have an interval that extends no more than 0.221 units from the observed difference with 90% coverage probability. Assumes CV of 35% for the difference on the original scale.||20.3|7.5|
72325422|NCT00508482|144174250|SUPERIORITY_OR_OTHER|||||||0.627||||||α was corrected by the method of Bonferroni as 0.0167 (α=0.05/3=0.0167).|Chi-squared|||||||0.627
72325423|NCT00508482|144174250|SUPERIORITY_OR_OTHER||||||<|0.001||||||α was corrected by the method of Bonferroni as 0.0167 (α=0.05/3=0.0167).|Chi-squared|||||||<0.001
72325424|NCT00508482|144174250|SUPERIORITY_OR_OTHER||||||<|0.001||||||α was corrected by the method of Bonferroni as 0.0167 (α=0.05/3=0.0167).|Chi-squared|||||||<0.001
72325425|NCT00508482|144174251|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Chi-squared|||||||<0.001
72325426|NCT00508482|144174251|SUPERIORITY_OR_OTHER|||||||0.587||||||α was corrected by the method of Bonferroni as 0.0167 (α=0.05/3=0.0167).|Chi-squared|||||||0.587
72608563|NCT03292016|144745704|OTHER||Geometric Mean ratio (APL-130277/APO-go)|10.3|||||TWO_SIDED|90.0|6.5|16.3||||||||16.3|6.5|
72608564|NCT03292016|144745704|OTHER|relative bioavailibilty|Geometric Mean ratio (APOKYN/APO-go)|83.4|||||TWO_SIDED|90.0|50.5|137.6||||||||137.6|50.5|
72608565|NCT03292016|144745704|OTHER||Ratio|0.21|||||||||||||The comparative bioavailability calculated as the ratio of the Test/Reference between APL 20 mg and APO-Go 3 mg|||||
72608566|NCT03292016|144745704|OTHER||Ratio|0.13|||||||||||||The comparative bioavailability calculated as the ratio of the Test/Reference between APL 20 mg and APOKYN 3 mg|||||
72325427|NCT00508482|144174251|SUPERIORITY_OR_OTHER|||||||0.001||||||α was corrected by the method of Bonferroni as 0.0167 (α=0.05/3=0.0167).|Chi-squared|||||||0.001
72325428|NCT00508482|144174251|SUPERIORITY_OR_OTHER||||||<|0.001||||||α was corrected by the method of Bonferroni as 0.0167 (α=0.05/3=0.0167).|Chi-squared|||||||<0.001
72325429|NCT00508482|144174252|SUPERIORITY_OR_OTHER|||||||0.006|||||||Chi-squared|||||||0.006
72325430|NCT00508482|144174252|SUPERIORITY_OR_OTHER|||||||0.507||||||α was corrected by the method of Bonferroni as 0.0167 (α=0.05/3=0.0167).|Chi-squared|||||||0.507
72325431|NCT00508482|144174252|SUPERIORITY_OR_OTHER|||||||0.005||||||α was corrected by the method of Bonferroni as 0.0167 (α=0.05/3=0.0167).|Chi-squared|||||||0.005
72325432|NCT00508482|144174252|SUPERIORITY_OR_OTHER|||||||0.008||||||α was corrected by the method of Bonferroni as 0.0167 (α=0.05/3=0.0167).|Chi-squared|||||||0.008
72417261|NCT02130193|144345271|SUPERIORITY_OR_OTHER||Posterior mean difference|0.05|STANDARD_DEVIATION|0.11||0.46|TWO_SIDED|95.0|-0.15|0.28||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.06 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FVC, Day 364. Data presented are for 95% equal-tailed credible intervals|||0.28|-0.15|0.46
72417262|NCT02130193|144345271|SUPERIORITY_OR_OTHER||Posterior mean difference|0.05|STANDARD_DEVIATION|0.11||0.4|TWO_SIDED|95.0|-0.15|0.28||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.08 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FVC, Day 364. Data presented are for 95% equal-tailed credible intervals|||0.28|-0.15|0.40
72608567|NCT03292016|144745704|OTHER||Ratio|1.16|||||||||||||The comparative bioavailability calculated as the ratio of the Test/Reference between APO-Go 3 mg and APOKYN 3 mg|||||
72325433|NCT02289469|144174276|SUPERIORITY||Mean Difference (Final Values)|23.8|||<|0.0001|TWO_SIDED|95.0|16.0|31.6|||Chi-squared|||A chi-square test was used to test for differences in proportions between intervention and control groups.||31.6|16.0|<0.0001
72325434|NCT02289469|144174277|OTHER||||||<|0.01|||||||Other|||Descriptive statistics (counts, frequencies) were used to summarize responses.||||<0.01
72325435|NCT00587041|144174286|SUPERIORITY_OR_OTHER|||||||0.3|||||||Kruskal-Wallis|||80% power for 0.66 DG difference from placebo. The reported value is the overall p-value for CaOx supersaturation by Kruskal-Wallis test of equal change across all three groups, no pair-wise comparison.||||0.3
72325436|NCT00587041|144174286|SUPERIORITY_OR_OTHER|||||||0.045||95.0|||||t-test, 1 sided|||Ranked sum T-test for placebo group CaOx SS comparison between 0 and 6 weeks||||0.045
72325437|NCT00587041|144174286|SUPERIORITY_OR_OTHER|||||||0.67||95.0|||||t-test, 1 sided|||Ranked sum T-test for AKSB group CaOX SS comparison between 0 and 6 weeks||||0.67
72325438|NCT00587041|144174286|SUPERIORITY_OR_OTHER|||||||0.3||95.0|||||t-test, 1 sided|||Ranked-sum T-Test for Oxadrop group CaOX SS comparison between 0 and 6 weeks||||0.30
72325439|NCT00776789|144174305|SUPERIORITY_OR_OTHER|||||||0.4||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.4
72325440|NCT00776789|144174306|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.5||||0||95.0|1.4|4.3|||Wilcoxon (Mann-Whitney)|||Exclusive breast feeding at 48 hours was 95% (19 out of 20 partcipants were exclusively breast feeding)in the skin-to-skin contact group vs. 38.1% in the control group||4.3|1.4|0.00
72325441|NCT00776789|144174307|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.5||||0.001||95.0|1.6|6.3|||Wilcoxon (Mann-Whitney)|||||6.3|1.6|0.001
72325442|NCT01628523|144174312|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.08|||<|0.05|TWO_SIDED||||||Regression, Logistic|||||||<0.05
72325443|NCT04290624|144174320|SUPERIORITY||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.05|<|0.0001|TWO_SIDED|95.0|-0.4|-0.2|||ANCOVA|||||-0.20|-0.40|<0.0001
72325444|NCT04290624|144174321|SUPERIORITY||Mean Difference (Final Values)|-28.6|STANDARD_ERROR_OF_MEAN|4.73|<|0.0001|TWO_SIDED|95.0|-38.1|-19.1|||ANCOVA|||At Week 6||-19.1|-38.1|<0.0001
72325445|NCT04290624|144174321|SUPERIORITY||Mean Difference (Final Values)|-27.9|STANDARD_ERROR_OF_MEAN|5.08|<|0.0001|TWO_SIDED|95.0|-38.2|-17.7|||ANCOVA|||At Week 12||-17.7|-38.2|<0.0001
72417263|NCT02130193|144345271|SUPERIORITY_OR_OTHER||Posterior mean difference|0.05|STANDARD_DEVIATION|0.11||0.33|TWO_SIDED|95.0|-0.15|0.28||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.10 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FVC, Day 364. Data presented are for 95% equal-tailed credible intervals|||0.28|-0.15|0.33
72417264|NCT02130193|144345275|SUPERIORITY_OR_OTHER||Posterior mean difference|2.48|STANDARD_DEVIATION|0.977||0.013|TWO_SIDED|95.0|0.92|4.43||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 1.0 is presented.|Bayesian Cox analysis|P-value is actually a posterior probability.|Data presented are for 95% equal-tailed credible intervals|||4.43|0.92|0.013
72608568|NCT03292016|144745704|OTHER||Ratio|0.16|||||||||||||The comparative bioavailability calculated as the ratio of the Test/Reference between APL 25 mg and APO-Go 4 mg|||||
72608569|NCT03292016|144745704|OTHER||Ratio|0.17|||||||||||||The comparative bioavailability calculated as the ratio of the Test/Reference between APL 25 mg and APOKYN 4 mg|||||
72608570|NCT03292016|144745704|OTHER||Ratio|1.12|||||||||||||The comparative bioavailability calculated as the ratio of the Test/Reference between APO-Go 4 mg and APOKYN 4 mg|||||
72325446|NCT04290624|144174322|SUPERIORITY||Mean Difference (Final Values)|-0.39|STANDARD_ERROR_OF_MEAN|0.062|<|0.0001|TWO_SIDED|95.0|-0.52|-0.27|||ANCOVA|||At Week 6||-0.27|-0.52|<0.0001
72325447|NCT04290624|144174322|SUPERIORITY||Mean Difference (Final Values)|-0.36|STANDARD_ERROR_OF_MEAN|0.054|<|0.0001|TWO_SIDED|95.0|-0.47|-0.25|||ANCOVA|||At Week 12||-0.25|-0.47|<0.0001
72325448|NCT04290624|144174323|SUPERIORITY||Mean Difference (Final Values)|-0.85|STANDARD_ERROR_OF_MEAN|0.142|<|0.0001|TWO_SIDED|95.0|-1.14|-0.56|||ANCOVA|||At Week 6||-0.56|-1.14|<0.0001
72325449|NCT04290624|144174323|SUPERIORITY||Mean Difference (Final Values)|-0.95|STANDARD_ERROR_OF_MEAN|0.139|<|0.0001|TWO_SIDED|95.0|-1.23|-0.67|||ANCOVA|||At Week 12||-0.67|-1.23|<0.0001
72325450|NCT04290624|144174324|SUPERIORITY||Mean Difference (Final Values)|-0.91|STANDARD_ERROR_OF_MEAN|0.151|<|0.0001|TWO_SIDED|95.0|-1.22|-0.61|||ANCOVA|||At Week 6||-0.61|-1.22|<0.0001
72325451|NCT04290624|144174324|SUPERIORITY||Mean Difference (Final Values)|-1.05|STANDARD_ERROR_OF_MEAN|0.154|<|0.0001|TWO_SIDED|95.0|-1.36|-0.74|||ANCOVA|||At Week 12||-0.74|-1.36|<0.0001
72325452|NCT04290624|144174325|SUPERIORITY||Mean Difference (Final Values)|-0.32|STANDARD_ERROR_OF_MEAN|0.045|<|0.0001|TWO_SIDED|95.0|-0.41|-0.23|||ANCOVA|||||-0.23|-0.41|<0.0001
72608571|NCT03292016|144745704|OTHER||Ratio|0.08|||||||||||||The comparative bioavailability calculated as the ratio of the Test/Reference between APL 30 mg and APO-Go 5 mg|||||
72417265|NCT02130193|144345275|SUPERIORITY_OR_OTHER||Posterior mean difference|2.48|STANDARD_DEVIATION|0.977||0.006|TWO_SIDED|95.0|0.92|4.43||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0.9 is presented.|Bayesian Cox analysis|P-value is actually a posterior probability.|Data presented are for 95% equal-tailed credible intervals|||4.43|0.92|0.006
72417266|NCT02130193|144345275|SUPERIORITY_OR_OTHER||Posterior mean difference|2.48|STANDARD_DEVIATION|0.977||0.003|TWO_SIDED|95.0|0.92|4.43||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0.8 is presented.|Bayesian Cox analysis|P-value is actually a posterior probability.|Data presented are for 95% equal-tailed credible intervals|||4.43|0.92|0.003
72417267|NCT02130193|144345275|SUPERIORITY_OR_OTHER||Posterior mean difference|2.48|STANDARD_DEVIATION|0.977||0.001|TWO_SIDED|95.0|0.92|4.43||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0.7 is presented.|Bayesian Cox analysis|P-value is actually a posterior probability.|Data presented are for 95% equal-tailed credible intervals|||4.43|0.92|0.001
72608572|NCT03292016|144745704|OTHER||Ratio|0.09|||||||||||||The comparative bioavailability calculated as the ratio of the Test/Reference between APL 30 mg and APOKYN 5 mg|||||
72608573|NCT03292016|144745704|OTHER||Ratio|1.04|||||||||||||The comparative bioavailability calculated as the ratio of the Test/Reference between APO-Go 5 mg and APOKYN 5 mg|||||
72608574|NCT03292016|144745705|OTHER|||||||0.0625|||||||Sign test|||||||0.0625
72325453|NCT04290624|144174326|SUPERIORITY||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|0.17||0.0039|TWO_SIDED|95.0|-0.9|-0.2|||ANCOVA|||At Week 6||-0.2|-0.9|0.0039
72325454|NCT04290624|144174326|SUPERIORITY||Mean Difference (Final Values)|-0.8|STANDARD_ERROR_OF_MEAN|0.15|<|0.0001|TWO_SIDED|95.0|-1.1|-0.5|||ANCOVA|||At Week 12||-0.5|-1.1|<0.0001
72325455|NCT04290624|144174327|SUPERIORITY||Mean Difference (Final Values)|-0.11|STANDARD_ERROR_OF_MEAN|0.05||0.0367|TWO_SIDED|95.0|-0.21|-0.01|||ANCOVA|||At Week 6||-0.01|-0.21|0.0367
72608575|NCT03292016|144745705|OTHER|||||||0.0313|||||||Sign test|||||||0.0313
72325456|NCT04290624|144174327|SUPERIORITY||Mean Difference (Final Values)|-0.08|STANDARD_ERROR_OF_MEAN|0.033||0.0725|TWO_SIDED|95.0|-0.14|-0.01|||Van-Elteren test|||At Week 12||-0.01|-0.14|0.0725
72325457|NCT04290624|144174328|SUPERIORITY||Mean Difference (Final Values)|-0.28|STANDARD_ERROR_OF_MEAN|0.075||0.0006|TWO_SIDED|95.0|-0.43|-0.13|||ANCOVA|||At Week 6||-0.13|-0.43|0.0006
72325458|NCT04290624|144174328|SUPERIORITY||Mean Difference (Final Values)|-0.26|STANDARD_ERROR_OF_MEAN|0.073||0.0009|TWO_SIDED|95.0|-0.41|-0.11|||ANCOVA|||At Week 12||-0.11|-0.41|0.0009
72325459|NCT04290624|144174329|SUPERIORITY||Mean Difference (Final Values)|-0.39|STANDARD_ERROR_OF_MEAN|0.117||0.002|TWO_SIDED|95.0|-0.62|-0.15|||ANCOVA|||At Week 6||-0.15|-0.62|0.0020
72417268|NCT02130193|144345275|SUPERIORITY_OR_OTHER||Posterior mean difference|2.48|STANDARD_DEVIATION|0.977|<|0.001|TWO_SIDED|95.0|0.92|4.43||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0.6 is presented.|Bayesian Cox analysis|P-value is actually a posterior probability.|Data presented are for 95% equal-tailed credible intervals|||4.43|0.92|<0.001
72608576|NCT03292016|144745705|OTHER||||||>|0.9999|||||||Sign test|||||||>0.9999
72608577|NCT03292016|144745706|OTHER||Geometric Mean Ratio (APL-130277/APOKYN)|17.2|||||TWO_SIDED|90.0|13.1|22.5|||Mixed Models Analysis|With fixed effects-treatment and period, random effect-subject nested within sequence to analyze natural-log transformed dose normalized parameter.||||22.5|13.1|
72608578|NCT03292016|144745706|OTHER||Geometric Mean Ratio (APL-130277/APOKYN)|16.7|||||TWO_SIDED|90.0|13.0|21.3|||Mixed Models Analysis|||||21.3|13.0|
72325460|NCT04290624|144174329|SUPERIORITY||Mean Difference (Final Values)|-0.34|STANDARD_ERROR_OF_MEAN|0.09||0.0005|TWO_SIDED|95.0|-0.52|-0.16|||ANCOVA|||At Week 12||-0.16|-0.52|0.0005
72608579|NCT03292016|144745706|OTHER||Geometric Mean Ratio (APOKYN/APO-go)|96.9|||||TWO_SIDED|90.0|74.2|126.4||||||||126.4|74.2|
72608580|NCT03292016|144745706|OTHER||Ratio|0.32|||||||||||||The comparative bioavailability calculated as the ratio of the Test/Reference between APL 20 mg and APO-Go 3 mg|||||
72608581|NCT03292016|144745706|OTHER||Ratio|0.16|||||||||||||The comparative bioavailability calculated as the ratio of the Test/Reference between APL 20 mg and APOKYN 3 mg|||||
72608582|NCT03292016|144745706|OTHER||Ratio|1.09|||||||||||||The comparative bioavailability calculated as the ratio of the Test/Reference between APO-Go 3 mg and APOKYN 3 mg|||||
72608583|NCT03292016|144745706|OTHER||Ratio|0.23|||||||||||||The comparative bioavailability calculated as the ratio of the Test/Reference between APL 25 mg and APO-Go 4 mg|||||
72608584|NCT03292016|144745706|OTHER||Ratio|0.23|||||||||||||The comparative bioavailability calculated as the ratio of the Test/Reference between APL 25 mg and APOKYN 4 mg|||||
72608585|NCT03292016|144745706|OTHER||Ratio|1.0|||||||||||||The comparative bioavailability calculated as the ratio of the Test/Reference between APO-Go 4 mg and APOKYN 4 mg|||||
72325461|NCT00956384|144174334|SUPERIORITY|A minimally clinically important difference of 4 as statistically significant at the 0.05 level (two-sided), with a power equal to 0.85.|Mean Difference (Final Values)|-2.69||||0.05|TWO_SIDED|95.0|-10.57|5.19||Threshold for statistical significance was p= 0.05|t-test, 2 sided|||For the comparison of mean BREAST-Q subdomain score at each timepoint, Mann-Whitney U test was used for skewed data, while independent t-test was used for not skewed data. We investigated the possibly variable effects of the treatment group differences across multiple time-points, namely 2 weeks after mastectomy, at 6 months and at 12 months following the reconstruction procedure. A linear regression model was used to account for the correlation between the three time-points within each patient||5.19|-10.57|0.05
72325462|NCT00956384|144174335|SUPERIORITY||||||<|0.05|TWO_SIDED|95.0|||||Regression, Logistic|||We assessed the effect of the surgical method on the occurrences of any complications versus none via logistic regression, and results were expressed as odds ratios with 95% CIs.||||<0.05
72417269|NCT02130193|144345276|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.36|STANDARD_DEVIATION|1.29||0.6|TWO_SIDED|95.0|-2.81|2.17||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS, 1 month. Data presented are for 95% equal-tailed credible intervals|||2.17|-2.81|0.60
72417270|NCT02130193|144345276|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.58|STANDARD_DEVIATION|1.42||0.65|TWO_SIDED|95.0|-3.11|2.37||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS, 2 month. Data presented are for 95% equal-tailed credible intervals|||2.37|-3.11|0.65
72417271|NCT02130193|144345276|SUPERIORITY_OR_OTHER||Posterior mean difference|-1.46|STANDARD_DEVIATION|1.52||0.83|TWO_SIDED|95.0|-4.43|1.45||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS, 3 month. Data presented are for 95% equal-tailed credible intervals|||1.45|-4.43|0.83
72417272|NCT02130193|144345276|SUPERIORITY_OR_OTHER||Posterior mean difference|-1.2|STANDARD_DEVIATION|1.53||0.78|TWO_SIDED|95.0|-4.07|1.9||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS, 4 month. Data presented are for 95% equal-tailed credible intervals|||1.90|-4.07|0.78
72417273|NCT02130193|144345276|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.96|STANDARD_DEVIATION|1.56||0.73|TWO_SIDED|95.0|-3.82|2.28||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS, 5 month. Data presented are for 95% equal-tailed credible intervals|||2.28|-3.82|0.73
72417274|NCT02130193|144345276|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.93|STANDARD_DEVIATION|1.58||0.72|TWO_SIDED|95.0|-4.01|2.26||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS, 6 month. Data presented are for 95% equal-tailed credible intervals|||2.26|-4.01|0.72
72608586|NCT03292016|144745706|OTHER||Ratio|0.15|||||||||||||The comparative bioavailability calculated as the ratio of the Test/Reference between APL 30 mg and APO-Go 5 mg|||||
72325463|NCT01088906|144174337|SUPERIORITY||Odds Ratio (OR)|34.0||||0.05|TWO_SIDED||||||Regression, Logistic|||||||0.05
72325464|NCT01847092|144174372|SUPERIORITY|||||||0.279|||||||Mixed Models Analysis|||||||0.279
72325465|NCT01847092|144174373|SUPERIORITY|||||||0.94|||||||ANCOVA|||||||0.94
72325466|NCT00461708|144174397|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Chi-squared|||||||<0.05
72325467|NCT00461708|144174398|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Chi-squared|||||||<0.05
72417275|NCT02130193|144345276|SUPERIORITY_OR_OTHER||Posterior mean difference|-1.0|STANDARD_DEVIATION|1.58||0.73|TWO_SIDED|95.0|-4.15|2.09||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS, 7 month. Data presented are for 95% equal-tailed credible intervals|||2.09|-4.15|0.73
72417276|NCT02130193|144345276|SUPERIORITY_OR_OTHER||Posterior mean difference|-1.48|STANDARD_DEVIATION|1.69||0.81|TWO_SIDED|95.0|-4.71|1.76||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS, 8 month. Data presented are for 95% equal-tailed credible intervals|||1.76|-4.71|0.81
72417277|NCT02130193|144345276|SUPERIORITY_OR_OTHER||Posterior mean difference|-1.23|STANDARD_DEVIATION|1.75||0.76|TWO_SIDED|95.0|-4.66|2.22||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS, 9 month. Data presented are for 95% equal-tailed credible intervals|||2.22|-4.66|0.76
72417278|NCT02130193|144345276|SUPERIORITY_OR_OTHER||Posterior mean difference|-2.26|STANDARD_DEVIATION|1.74||0.91|TWO_SIDED|95.0|-5.66|0.99||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS, 10 month. Data presented are for 95% equal-tailed credible intervals|||0.99|-5.66|0.91
72417279|NCT02130193|144345276|SUPERIORITY_OR_OTHER||Posterior mean difference|-1.05|STANDARD_DEVIATION|1.73||0.71|TWO_SIDED|95.0|-4.73|2.13||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS, 11 month. Data presented are for 95% equal-tailed credible intervals|||2.13|-4.73|0.71
72417280|NCT02130193|144345276|SUPERIORITY_OR_OTHER||Posterior mean difference|-1.35|STANDARD_DEVIATION|1.74||0.78|TWO_SIDED|95.0|-4.77|2.04||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS, 12 month. Data presented are for 95% equal-tailed credible intervals|||2.04|-4.77|0.78
72417281|NCT02130193|144345280|SUPERIORITY_OR_OTHER||Posterior mean difference|1.15|STANDARD_DEVIATION|0.242||0.278|TWO_SIDED|95.0|0.71|1.63||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 1.0 is presented.|Bayesian Cox analysis|P-value is actually a posterior probability.|Data presented are for 95% equal-tailed credible intervals|||1.63|0.71|0.278
72608587|NCT03292016|144745706|OTHER||Ratio|0.14|||||||||||||The comparative bioavailability calculated as the ratio of the Test/Reference between APL 30 mg and APOKYN 5 mg|||||
72608588|NCT03292016|144745706|OTHER||Ratio|0.96|||||||||||||The comparative bioavailability calculated as the ratio of the Test/Reference between APO-Go 5 mg and APOKYN 5 mg|||||
72608589|NCT03292016|144745707|OTHER||Geometric Mean Ratio (APL-130277/APOKYN)|17.6|||||TWO_SIDED|90.0|13.7|22.5|||Mixed Models Analysis|With fixed effects-treatment and period, random effect-subject nested within sequence to analyze natural-log transformed dose normalized parameter.||||22.5|13.7|
72608590|NCT03292016|144745707|OTHER||Geometric Mean Ratio (APL-130277/APO-go)|17.2|||||TWO_SIDED|90.0|13.7|21.6|||Mixed Models Analysis|||||21.6|13.7|
72325468|NCT02394561|144174399|NON_INFERIORITY|The difference in percentage of patients achieving PASI 90 response between the Cw6-positive cohort and the Cw6-negative cohort was H0 = Cw6-positive minus Cw6-negative ≥0.12 and HA = Cw6-positive minus Cw6-negative was \< 0.12. The percentage of PASI 90 response by cohort as well as the difference between cohort together with 97.5% upper CI was provided using Clopper Pearson CI method.|difference|-1.3|||||TWO_SIDED|95.0|-8.8|6.2||||||||6.2|-8.8|
72325469|NCT02394561|144174402|OTHER|difference between cohorts for PASI 90 using Kaplan-Meier estimate||||||0.1295|||||||Log Rank|||||||0.1295
72325470|NCT02394561|144174402|OTHER|||||||0.447||||||difference between cohorts for PASI 75 using Kaplan-Meier estimate|Log Rank|||||||0.4470
72325471|NCT02394561|144174403|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|At all time points||||||<.0001
72325472|NCT02394561|144174404|SUPERIORITY||||||<|0.0001||||||All time points|Wilcoxon (Mann-Whitney)|||||||<.0001
72325473|NCT02553629|144174419|SUPERIORITY_OR_OTHER|||||||0.001|||||||Mixed Models Analysis|||||||0.001
72325474|NCT02553629|144174420|SUPERIORITY_OR_OTHER||||||>|0.05|||||||t-test, 2 sided|||||||>0.05
72325475|NCT02553629|144174421|SUPERIORITY_OR_OTHER|||||||0.04|||||||t-test, 2 sided|||||||0.04
72608591|NCT03292016|144745707|OTHER||Geometric Mean Ratio (APOKYN/APO-go)|97.8|||||TWO_SIDED|90.0|76.6|124.8|||Mixed Models Analysis|||||124.8|76.6|
72325476|NCT02553629|144174422|SUPERIORITY_OR_OTHER||||||>|0.05|||||||t-test, 2 sided|||||||>0.05
72325477|NCT02553629|144174423|SUPERIORITY_OR_OTHER||||||>|0.05|||||||t-test, 2 sided|||||||>0.05
72325478|NCT01812057|144174424|SUPERIORITY|||||||0.74|||||||Wilcoxon (Mann-Whitney)|||||||0.740
72325479|NCT01812057|144174425|SUPERIORITY|Pain Score at rest at 2 hours||||||0.171|||||||t-test, 2 sided|||||||0.171
72325480|NCT01812057|144174425|SUPERIORITY|Pain Score with movement at 2 hours||||||0.204|||||||t-test, 2 sided|||||||0.204
72325481|NCT01812057|144174426|SUPERIORITY|||||||0.1965|||||||Log Rank|||||||0.1965
72325482|NCT01812057|144174427|SUPERIORITY|||||||0.709|||||||Wilcoxon (Mann-Whitney)|||||||0.709
72325483|NCT01812057|144174428|SUPERIORITY|Pain Score at rest at 24 hours||||||0.267|||||||Wilcoxon (Mann-Whitney)|||||||0.267
72325484|NCT01812057|144174428|SUPERIORITY|Pain Score with movement at 24 hours||||||0.518|||||||t-test, 2 sided|||||||0.518
72325485|NCT01812057|144174429|SUPERIORITY|Pain Score at rest at 48 hours||||||0.491|||||||Wilcoxon (Mann-Whitney)|||||||0.491
72325486|NCT01812057|144174429|SUPERIORITY|Pain Scores with movement at 48 hours||||||0.525|||||||Wilcoxon (Mann-Whitney)|||||||0.525
72325487|NCT01812057|144174430|SUPERIORITY|||||||0.355|||||||Wilcoxon (Mann-Whitney)|Total opioid consumption at 24 hours|||We also performed a multivariable regression analysis to determine factors associated with 24h opioid consumption accounting for MTS category, demographic factors, study group allocation (dexamethasone vs placebo) and a preoperative questions to assess patients anxiety, anticipated pain scores after surgery and anticipated analgesic need after surgery. At each step of backward variable selection, we eliminate the factor with the largest p-value over 0.05.In the final model MTS was not associated with 24h opioid consumption parameter estimate (standard error) = 9.15 (5.27), p=0.09.|||0.355
72325488|NCT01812057|144174431|SUPERIORITY|||||||0.42|||||||Fisher Exact|Chronic pain at 8 weeks||||||0.420
72325489|NCT01812057|144174432|SUPERIORITY|||||||0.322|||||||Fisher Exact|||||||0.322
72325490|NCT01812057|144174433|SUPERIORITY|||||||0.805|||||||Wilcoxon (Mann-Whitney)|||24 hour pain scores at rest between MTS groups|We also performed a multivariable regression analysis to determine factors associated with Pain scores at rest at 24 hours accounting for MTS category, demographic factors, study group allocation (dexamethasone vs placebo) and a preoperative questions to assess patients anxiety, anticipated pain scores after surgery and anticipated analgesic need after surgery. At each step of backward variable selection, we eliminate the factors with the largest p-value over 0.05. MTS category was not included in the final model for 24 h pain scores at rest.|||0.805
72325491|NCT01812057|144174433|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Pain scores on movement at 24h|We also performed a multivariable regression analysis to determine factors associated with Pain scores at rest at 24 hours accounting for MTS category, demographic factors, study group allocation (dexamethasone vs placebo) and a preoperative questions to assess patients anxiety, anticipated pain scores after surgery and anticipated analgesic need after surgery. At each step of backward variable selection, we eliminated the factors with the largest p-value over 0.05. MTS category was not included in the final model for 24 h pain scores on movement.|||1.000
72325492|NCT01812057|144174434|SUPERIORITY|Intraoperative nausea and vomiting||||||0.245|||||||Fisher Exact|||||||0.245
72325493|NCT01812057|144174434|SUPERIORITY|||||||0.676|||||||Chi-squared|Need for intraoperative antiemetics||||||0.676
72325494|NCT01812057|144174434|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.000
72325495|NCT01812057|144174436|SUPERIORITY|||||||0.924|||||||Chi-squared|Incidence of postoperative pruritus||||||0.924
72325496|NCT01812057|144174437|SUPERIORITY|||||||0.7|||||||Fisher Exact|||||||0.700
72325497|NCT01812057|144174438|SUPERIORITY|||||||0.302|||||||Chi-squared|Incidence of PONV at 24 h||||||0.302
72325498|NCT01812057|144174438|SUPERIORITY|||||||0.028|||||||Chi-squared|Postoperative need for rescue antiemetic||||||0.028
72325499|NCT01812057|144174438|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.000
72325500|NCT01812057|144174438|SUPERIORITY|||||||0.188|||||||Chi-squared|||||||0.188
72608592|NCT03292016|144745712|OTHER|||||||0.0313|||||||Wilcoxon (Mann-Whitney)|||||||0.0313
72608593|NCT03292016|144745712|OTHER|||||||0.0625|||||||Wilcoxon (Mann-Whitney)|||||||0.0625
72608594|NCT03292016|144745712|OTHER||||||>|0.9999|||||||Wilcoxon (Mann-Whitney)|||||||>0.9999
72608595|NCT01076543|144745722|OTHER||Maximum tolerated dose in mg|20.0|||||TWO_SIDED||||||||"The maximum tolerated dose (MTD) was determined using the traditional 3+3 design and was the maximum dose level such that less than 33% of the patients (i.e, \<1 of 3 or \<2 of 6) experience dose-limiting toxicity."|||||
72608596|NCT01076543|144745724|SUPERIORITY||||||>|0.1|||||||Binomial exact test|The number of responders required to reject the null hypothesis was 16 or more.||Two-stage, minimax design was used to test the null hypothesis that the overall response rate was 30% vs. a 50% alternative.||||>0.10
72417282|NCT02130193|144345280|SUPERIORITY_OR_OTHER||Posterior mean difference|1.15|STANDARD_DEVIATION|0.242||0.138|TWO_SIDED|95.0|0.71|1.63||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0.9 is presented.|Bayesian Cox analysis|P-value is actually a posterior probability.|Data presented are for 95% equal-tailed credible intervals|||1.63|0.71|0.138
72417283|NCT02130193|144345280|SUPERIORITY_OR_OTHER||Posterior mean difference|1.15|STANDARD_DEVIATION|0.242||0.05|TWO_SIDED|95.0|0.71|1.63||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0.8 is presented.|Bayesian Cox analysis|P-value is actually a posterior probability.|Data presented are for 95% equal-tailed credible intervals|||1.63|0.71|0.05
72417284|NCT02130193|144345280|SUPERIORITY_OR_OTHER||Posterior mean difference|1.15|STANDARD_DEVIATION|0.242||0.011|TWO_SIDED|95.0|0.71|1.63||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0.7 is presented.|Bayesian Cox analysis|P-value is actually a posterior probability.|Data presented are for 95% equal-tailed credible intervals|||1.63|0.71|0.011
72417285|NCT02130193|144345280|SUPERIORITY_OR_OTHER||Posterior mean difference|1.15|STANDARD_DEVIATION|0.242||0.002|TWO_SIDED|95.0|0.71|1.63||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0.6 is presented.|Bayesian Cox analysis|P-value is actually a posterior probability.|Data presented are for 95% equal-tailed credible intervals|||1.63|0.71|0.002
72417286|NCT02130193|144345281|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.57|STANDARD_DEVIATION|2.04||0.62|TWO_SIDED|95.0|-4.55|3.23||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 1 month. Data presented are for 95% equal-tailed credible intervals|||3.23|-4.55|0.62
72417287|NCT02130193|144345281|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.72|STANDARD_DEVIATION|2.21||0.64|TWO_SIDED|95.0|-5.03|3.6||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 2 month. Data presented are for 95% equal-tailed credible intervals|||3.60|-5.03|0.64
72417288|NCT02130193|144345281|SUPERIORITY_OR_OTHER||Posterior mean difference|-1.99|STANDARD_DEVIATION|2.29||0.81|TWO_SIDED|95.0|-6.6|2.27||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 3 month. Data presented are for 95% equal-tailed credible intervals|||2.27|-6.60|0.81
72608597|NCT01076543|144745724|SUPERIORITY|||||||||||||||||Two-stage, minimax design was used to test the null hypothesis that the overall response rate was 50% vs. 70% alternative.|The follicular subgroup did not reach its accrual goal and was closed.|||
72608598|NCT01076543|144745724|SUPERIORITY||||||<|0.1|||||||Binomial exact test.|The number of responders required to reject the null hypothesis was 16 or more.||Two-stage, minimax design was used to test the null hypothesis that the overall response rate was 30% vs. a 50% alternative.||||<0.10
72608599|NCT01791985|144745730|OTHER||Mean|0.08|STANDARD_DEVIATION|0.32|||TWO_SIDED|||||||||Proportion of change in tumour size at 12 weeks (or progression if prior to week 12), when used in combination with either anastrozole or letrozole in ER positive breast cancer patients who have progressed on treatment with either anastrozole or letrozole in any setting||||
72417289|NCT02130193|144345281|SUPERIORITY_OR_OTHER||Posterior mean difference|-1.64|STANDARD_DEVIATION|2.31||0.77|TWO_SIDED|95.0|-5.92|3.07||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 4 month. Data presented are for 95% equal-tailed credible intervals|||3.07|-5.92|0.77
72417290|NCT02130193|144345281|SUPERIORITY_OR_OTHER||Posterior mean difference|-1.3|STANDARD_DEVIATION|2.4||0.71|TWO_SIDED|95.0|-5.7|3.55||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 5 month. Data presented are for 95% equal-tailed credible intervals|||3.55|-5.70|0.71
72417291|NCT02130193|144345281|SUPERIORITY_OR_OTHER||Posterior mean difference|-1.31|STANDARD_DEVIATION|2.42||0.7|TWO_SIDED|95.0|-6.46|3.05||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 6 month. Data presented are for 95% equal-tailed credible intervals|||3.05|-6.46|0.70
72417292|NCT02130193|144345281|SUPERIORITY_OR_OTHER||Posterior mean difference|-1.6|STANDARD_DEVIATION|2.45||0.74|TWO_SIDED|95.0|-6.75|2.9||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 7 month. Data presented are for 95% equal-tailed credible intervals|||2.90|-6.75|0.74
72417293|NCT02130193|144345281|SUPERIORITY_OR_OTHER||Posterior mean difference|-2.1|STANDARD_DEVIATION|2.63||0.79|TWO_SIDED|95.0|-6.93|3.3||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 8 month. Data presented are for 95% equal-tailed credible intervals|||3.30|-6.93|0.79
72417294|NCT02130193|144345281|SUPERIORITY_OR_OTHER||Posterior mean difference|-1.92|STANDARD_DEVIATION|2.63||0.77|TWO_SIDED|95.0|-7.04|3.18||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 9 month. Data presented are for 95% equal-tailed credible intervals|||3.18|-7.04|0.77
72608600|NCT00767572|144745746|SUPERIORITY_OR_OTHER||||||>|0.05||95.0||||Significance threshold p\<0.05|t-test, 2 sided|||Null hypothesis: pre-post brachial artery diameter changes do not differ between placebo and atorvastatin||||>0.05
72608601|NCT02357459|144745800|SUPERIORITY|The analysis included all study weeks of data, and was not confined to only that at Baseline and Week 12. Descriptive statistics included number of observations, unadjusted mean, standard deviation, median, minimum and maximum, and baseline adjusted means from the mixed model. Treatment differences from control was presented, and estimated via least squares means from the analysis model along with 95% confidence intervals and associated 2-sided p-values.|Mean Difference (Final Values)|-0.98|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001|TWO_SIDED|95.0|-1.47|-0.49||The threshold for significance was \<0.05.|longitudinal mixed repeated measures|||||-0.49|-1.47|<0.0001
72417295|NCT02130193|144345281|SUPERIORITY_OR_OTHER||Posterior mean difference|-3.44|STANDARD_DEVIATION|2.72||0.9|TWO_SIDED|95.0|-8.74|1.87||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 10 month. Data presented are for 95% equal-tailed credible intervals|||1.87|-8.74|0.90
72417296|NCT02130193|144345281|SUPERIORITY_OR_OTHER||Posterior mean difference|-1.16|STANDARD_DEVIATION|2.72||0.66|TWO_SIDED|95.0|-6.2|4.2||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 11 month. Data presented are for 95% equal-tailed credible intervals|||4.20|-6.20|0.66
72417297|NCT02130193|144345281|SUPERIORITY_OR_OTHER||Posterior mean difference|-1.73|STANDARD_DEVIATION|2.7||0.74|TWO_SIDED|95.0|-6.91|3.45||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 12 month. Data presented are for 95% equal-tailed credible intervals|||3.45|-6.91|0.74
72417298|NCT02130193|144345281|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.57|STANDARD_DEVIATION|2.04||0.43|TWO_SIDED|95.0|-4.55|3.23||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -1 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 1 month. Data presented are for 95% equal-tailed credible intervals|||3.23|-4.55|0.43
72417299|NCT02130193|144345281|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.72|STANDARD_DEVIATION|2.21||0.45|TWO_SIDED|95.0|-5.03|3.6||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -1 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 2 month. Data presented are for 95% equal-tailed credible intervals|||3.60|-5.03|0.45
72417300|NCT02130193|144345281|SUPERIORITY_OR_OTHER||Posterior mean difference|-1.99|STANDARD_DEVIATION|2.29||0.67|TWO_SIDED|95.0|-6.6|2.27||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -1 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 3 month. Data presented are for 95% equal-tailed credible intervals|||2.27|-6.60|0.67
72417301|NCT02130193|144345281|SUPERIORITY_OR_OTHER||Posterior mean difference|-1.64|STANDARD_DEVIATION|2.31||0.62|TWO_SIDED|95.0|-5.92|3.07||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -1 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 4 month. Data presented are for 95% equal-tailed credible intervals|||3.07|-5.92|0.62
72608602|NCT01548599|144745814|SUPERIORITY||Odds Ratio, log|2.028||||0.002|TWO_SIDED|95.0|0.766|3.289|||Mixed Models Analysis|||||3.289|0.766|0.002
72417302|NCT02130193|144345281|SUPERIORITY_OR_OTHER||Posterior mean difference|-1.3|STANDARD_DEVIATION|2.4||0.55|TWO_SIDED|95.0|-5.7|3.55||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -1 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 5 month. Data presented are for 95% equal-tailed credible intervals|||3.55|-5.70|0.55
72417303|NCT02130193|144345281|SUPERIORITY_OR_OTHER||Posterior mean difference|-1.31|STANDARD_DEVIATION|2.42||0.55|TWO_SIDED|95.0|-6.46|3.05||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -1 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 6 month. Data presented are for 95% equal-tailed credible intervals|||3.05|-6.46|0.55
72417304|NCT02130193|144345281|SUPERIORITY_OR_OTHER||Posterior mean difference|-1.6|STANDARD_DEVIATION|2.45||0.59|TWO_SIDED|95.0|-6.75|2.9||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -1 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 7 month. Data presented are for 95% equal-tailed credible intervals|||2.90|-6.75|0.59
72417305|NCT02130193|144345281|SUPERIORITY_OR_OTHER||Posterior mean difference|-2.1|STANDARD_DEVIATION|2.63||0.65|TWO_SIDED|95.0|-6.93|3.3||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -1 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 8 month. Data presented are for 95% equal-tailed credible intervals|||3.30|-6.93|0.65
72417306|NCT02130193|144345281|SUPERIORITY_OR_OTHER||Posterior mean difference|-1.92|STANDARD_DEVIATION|2.63||0.63|TWO_SIDED|95.0|-7.04|3.18||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -1 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 9 month. Data presented are for 95% equal-tailed credible intervals|||3.18|-7.04|0.63
72417307|NCT02130193|144345281|SUPERIORITY_OR_OTHER||Posterior mean difference|-3.44|STANDARD_DEVIATION|2.72||0.81|TWO_SIDED|95.0|-8.74|1.87||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -1 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 10 month. Data presented are for 95% equal-tailed credible intervals|||1.87|-8.74|0.81
72417308|NCT02130193|144345281|SUPERIORITY_OR_OTHER||Posterior mean difference|-1.16|STANDARD_DEVIATION|2.72||0.52|TWO_SIDED|95.0|-6.2|4.2||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -1 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 11 month. Data presented are for 95% equal-tailed credible intervals|||4.20|-6.20|0.52
72608603|NCT01548599|144745815|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
72608604|NCT01548599|144745816|SUPERIORITY|||||||0.013|||||||Mixed Models Analysis|||||||0.013
72608605|NCT01548599|144745817|SUPERIORITY||Odds Ratio (OR)|0.261|STANDARD_ERROR_OF_MEAN|0.398||0.378|TWO_SIDED|95.0|0.013|5.165|||Mixed Models Analysis|||||5.165|0.013|0.378
72608606|NCT01548599|144745818|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
72608607|NCT01548599|144745819|SUPERIORITY|||||||0.398|||||||Mixed Models Analysis|||||||0.398
72608608|NCT05630196|144745820|SUPERIORITY||Posterior Mean Difference|0.39|||||TWO_SIDED|95.0|-0.22|1.0|||||Posterior mean difference with 95% credible interval is reported.|||1.00|-0.22|
72608609|NCT05630196|144745821|SUPERIORITY||Posterior Mean Difference|1.16|||||TWO_SIDED|95.0|-0.44|2.77|||||Posterior mean difference with 95% credible interval is reported.|||2.77|-0.44|
72608610|NCT05630196|144745822|SUPERIORITY||Posterior Mean Difference|0.22|||||TWO_SIDED|95.0|-0.23|0.67|||||Posterior mean difference with 95% credible interval is reported.|||0.67|-0.23|
72608611|NCT05630196|144745823|SUPERIORITY||Posterior Mean Difference|0.52|||||TWO_SIDED|95.0|-0.13|1.18|||||Posterior mean difference with 95% credible interval is reported.|||1.18|-0.13|
72608612|NCT05630196|144745824|SUPERIORITY||Posterior Mean Difference|4.2|||||TWO_SIDED|95.0|-3.51|11.87|||||Posterior mean difference with 95% credible interval is reported.|||11.87|-3.51|
72417309|NCT02130193|144345281|SUPERIORITY_OR_OTHER||Posterior mean difference|-1.73|STANDARD_DEVIATION|2.7||0.6|TWO_SIDED|95.0|-6.91|3.45||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -1 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 12 month. Data presented are for 95% equal-tailed credible intervals|||3.45|-6.91|0.60
72417310|NCT02130193|144345281|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.57|STANDARD_DEVIATION|2.04||0.24|TWO_SIDED|95.0|-4.55|3.23||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -2 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 1 month. Data presented are for 95% equal-tailed credible intervals|||3.23|-4.55|0.24
72417311|NCT02130193|144345281|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.72|STANDARD_DEVIATION|2.21||0.28|TWO_SIDED|95.0|-5.03|3.6||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -2 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 2 month. Data presented are for 95% equal-tailed credible intervals|||3.60|-5.03|0.28
72417312|NCT02130193|144345281|SUPERIORITY_OR_OTHER||Posterior mean difference|-1.99|STANDARD_DEVIATION|2.29||0.5|TWO_SIDED|95.0|-6.6|2.27||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -2 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 3 month. Data presented are for 95% equal-tailed credible intervals|||2.27|-6.60|0.50
72417313|NCT02130193|144345281|SUPERIORITY_OR_OTHER||Posterior mean difference|-1.64|STANDARD_DEVIATION|2.31||0.43|TWO_SIDED|95.0|-5.92|3.07||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -2 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 4 month. Data presented are for 95% equal-tailed credible intervals|||3.07|-5.92|0.43
72417314|NCT02130193|144345281|SUPERIORITY_OR_OTHER||Posterior mean difference|-1.3|STANDARD_DEVIATION|2.4||0.37|TWO_SIDED|95.0|-5.7|3.55||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -2 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 5 month. Data presented are for 95% equal-tailed credible intervals|||3.55|-5.70|0.37
72608613|NCT05630196|144745825|SUPERIORITY||Posterior Mean Difference|-0.34|||||TWO_SIDED|95.0|-0.74|0.05|||||Posterior mean difference with 95% credible interval is reported.|||0.05|-0.74|
72608614|NCT05630196|144745826|SUPERIORITY||Posterior Mean Difference|-11.11|||||TWO_SIDED|95.0|-159.85|136.77|||||Posterior mean difference with 95% credible interval is reported.|||136.77|-159.85|
72608615|NCT05630196|144745827|SUPERIORITY||Posterior Mean Difference|-0.01|||||TWO_SIDED|95.0|-0.11|0.08|||||Posterior mean difference with 95% credible interval is reported.|||0.08|-0.11|
72417315|NCT02130193|144345281|SUPERIORITY_OR_OTHER||Posterior mean difference|-1.31|STANDARD_DEVIATION|2.42||0.38|TWO_SIDED|95.0|-6.46|3.05||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -2 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 6 month. Data presented are for 95% equal-tailed credible intervals|||3.05|-6.46|0.38
72417316|NCT02130193|144345281|SUPERIORITY_OR_OTHER||Posterior mean difference|-1.6|STANDARD_DEVIATION|2.45||0.43|TWO_SIDED|95.0|-6.75|2.9||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -2 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 7 month. Data presented are for 95% equal-tailed credible intervals|||2.90|-6.75|0.43
72417317|NCT02130193|144345281|SUPERIORITY_OR_OTHER||Posterior mean difference|-2.1|STANDARD_DEVIATION|2.63||0.51|TWO_SIDED|95.0|-6.93|3.3||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -2 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 8 month. Data presented are for 95% equal-tailed credible intervals|||3.30|-6.93|0.51
72417318|NCT02130193|144345281|SUPERIORITY_OR_OTHER||Posterior mean difference|-1.92|STANDARD_DEVIATION|2.63||0.5|TWO_SIDED|95.0|-7.04|3.18||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -2 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 9 month. Data presented are for 95% equal-tailed credible intervals|||3.18|-7.04|0.50
72417319|NCT02130193|144345281|SUPERIORITY_OR_OTHER||Posterior mean difference|-3.44|STANDARD_DEVIATION|2.72||0.7|TWO_SIDED|95.0|-8.74|1.87||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -2 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 10 month. Data presented are for 95% equal-tailed credible intervals|||1.87|-8.74|0.70
72417320|NCT02130193|144345281|SUPERIORITY_OR_OTHER||Posterior mean difference|-1.16|STANDARD_DEVIATION|2.72||0.38|TWO_SIDED|95.0|-6.2|4.2||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -2 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 11 month. Data presented are for 95% equal-tailed credible intervals|||4.20|-6.20|0.38
72417321|NCT02130193|144345281|SUPERIORITY_OR_OTHER||Posterior mean difference|-1.73|STANDARD_DEVIATION|2.7||0.45|TWO_SIDED|95.0|-6.91|3.45||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -2 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 12 month. Data presented are for 95% equal-tailed credible intervals|||3.45|-6.91|0.45
72608616|NCT03438266|144745828|NON_INFERIORITY|If the upper limit of the confidence interval at Month 1 was less than 0.5, then treatment with cannula was considered non-inferior to treatment with needle.|Mean Difference (Final Values)|0.1|||||TWO_SIDED|95.0|-0.05|0.25|||||The 95% CI is based on the paired t-test.|Change from Baseline at Month 1||0.25|-0.05|
72608617|NCT03438266|144745829|OTHER||Percentage Difference|-1.7|||||TWO_SIDED|95.0|-7.31|3.98||||||||3.98|-7.31|
72417322|NCT02130193|144345281|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.57|STANDARD_DEVIATION|2.04||0.11|TWO_SIDED|95.0|-4.55|3.23||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -3 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 1 month. Data presented are for 95% equal-tailed credible intervals|||3.23|-4.55|0.11
72417323|NCT02130193|144345281|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.72|STANDARD_DEVIATION|2.21||0.15|TWO_SIDED|95.0|-5.03|3.6||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -3 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 2 month. Data presented are for 95% equal-tailed credible intervals|||3.60|-5.03|0.15
72417324|NCT02130193|144345281|SUPERIORITY_OR_OTHER||Posterior mean difference|-1.99|STANDARD_DEVIATION|2.29||0.32|TWO_SIDED|95.0|-6.6|2.27||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -3 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 3 month. Data presented are for 95% equal-tailed credible intervals|||2.27|-6.60|0.32
72417325|NCT02130193|144345281|SUPERIORITY_OR_OTHER||Posterior mean difference|-1.64|STANDARD_DEVIATION|2.31||0.28|TWO_SIDED|95.0|-5.92|3.07||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -3 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 4 month. Data presented are for 95% equal-tailed credible intervals|||3.07|-5.92|0.28
72417326|NCT02130193|144345281|SUPERIORITY_OR_OTHER||Posterior mean difference|-1.3|STANDARD_DEVIATION|2.4||0.23|TWO_SIDED|95.0|-5.7|3.55||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -3 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 5 month. Data presented are for 95% equal-tailed credible intervals|||3.55|-5.70|0.23
72608618|NCT02990000|144745839|SUPERIORITY|We used the Optimal Design program to determine the minimum numbers of therapists and patients needed to detect a moderate effect of condition (standardized difference between change rates = .50). Based on this a priori power analysis, we will need a total of 44 therapists and 211 patients to achieve a power of .80 to detect moderate condition effects. Factoring in a 25% dropout rate, enrolling 281 patients should provide sufficient statistical power.|condition effect on weekly change rate|-0.04|STANDARD_ERROR_OF_MEAN|0.01||0.02|TWO_SIDED|95.0|-0.05|-0.03|||3-level hierarchical linear model|||To account for the nested nature of the data (time points nested within patients nested within therapists), a 3-level hierarchical linear model was used to test the effect of condition (Scientific Match = 1; Pragmatic Match = 0) on weekly during-treatment change on the TOP-CS average z-scores. Given that higher TOP-CS z-scores indicate greater impairment, negative slopes indicate a weekly decrease in impairment during treatment (i.e., a better outcome or more improvement).||-0.03|-0.05|.02
72608619|NCT02990000|144745840|SUPERIORITY||condition effect on weekly change rate|-0.16|STANDARD_ERROR_OF_MEAN|0.07||0.03|TWO_SIDED|95.0|-0.3|-0.02|||3-level hierarchical linear model|||To account for the nested nature of the data (time points nested within patients nested within therapists), a 3-level hierarchical linear model was used to test the effect of condition (Scientific Match = 1; Pragmatic Match = 0) on weekly during-treatment change on the SCL-10 total score. Given that higher SCL-10 scores indicate greater psychological distress, negative slopes indicate a weekly decrease in impairment during treatment (i.e., a better outcome or more improvement).||-0.02|-0.30|.03
72608620|NCT02990000|144745841|SUPERIORITY||condition effect on weekly change rate|-0.07|STANDARD_ERROR_OF_MEAN|0.15||0.65|TWO_SIDED|95.0|-0.33|0.21|||3-level hierarchical linear model|||To account for the nested nature of the data (time points nested within patients nested within therapists), a 3-level hierarchical linear model was used to test the effect of condition (Scientific Match = 1; Pragmatic Match = 0) on weekly during-treatment change on the patient-rated WAI. Given that higher WAI scores indicate better quality therapeutic alliances, positive slopes indicate a weekly increase in alliance during treatment (i.e., a better outcome or more improvement).||0.21|-0.33|.65
72608621|NCT02990000|144745842|SUPERIORITY||condition effect on weekly change rate|-0.06|STANDARD_ERROR_OF_MEAN|0.07||0.41|TWO_SIDED|95.0|-0.17|0.07|||3-level hierarchical linear model|||To account for the nested nature of the data (time points nested within patients nested within therapists), a 3-level hierarchical linear model was used to test the effect of condition (Scientific Match = 1; Pragmatic Match = 0) on weekly during-treatment change on the OE subscale of the CEQ. Given that higher OE scores indicate more optimistic expectations, positive slopes indicate a weekly increase in OE during treatment (i.e., a better outcome or more improvement).||0.07|-0.17|.41
72608622|NCT02990000|144745843|SUPERIORITY||condition effect on weekly change rate|-0.01|STANDARD_ERROR_OF_MEAN|0.002||0.01|TWO_SIDED|95.0|-0.01|-0.006|||3-level hierarchical linear model|||To account for the nested nature of the data (time points nested within patients nested within therapists), a 3-level hierarchical linear model was used to test the effect of condition (Scientific Match = 1; Pragmatic Match = 0) on weekly during-treatment change on the log-transformed TOP-CS domain-specific z-scores. Given that higher z-scores indicate greater impairment, negative slopes indicate a weekly decrease in impairment during treatment (i.e., a better outcome or more improvement).||-0.006|-0.01|.01
72608623|NCT02990000|144745844|SUPERIORITY||Odds Ratio (OR)|1.3|STANDARD_ERROR_OF_MEAN|0.48||0.48|TWO_SIDED||||||Multilevel logistic regression|||Multilevel logistic regression analysis with patients nested within therapists (Scientific Match = 1; Pragmatic Match = 0). Statistically significant odds ratios that are greater than 1 would indicate that patients in the Scientific Match Condition were more likely to discontinue treatment early, whereas odds ratios that are less than 1 would indicate the opposite.||||.48
72608624|NCT02990000|144745845|SUPERIORITY||condition effect on satisfaction|0.37|STANDARD_ERROR_OF_MEAN|0.48||0.44|TWO_SIDED|95.0|-0.57|1.31|||2-level hierarchical linear model|||Due to the nested nature of the data (patients nested within therapists), we used a two-level hierarchical linear model to test the effect of condition on provider satisfaction at posttreatment. Because higher values indicate more satisfaction, a positive condition effect would indicate that Scientific Match patients were more satisfied than Pragmatic Match patients, whereas a negative condition effect would indicate the opposite.||1.31|-0.57|.44
72608625|NCT02308046|144745846|SUPERIORITY|||||||0.002|||||||Chi-squared, Corrected|||||||0.002
72608626|NCT02308046|144745847|SUPERIORITY||||||<|0.001|||||||Chi-squared, Corrected|||||||<0.001
72608627|NCT02308046|144745848|SUPERIORITY||||||<|0.001|||||||Chi-squared, Corrected|||Comparison of culture cure at 7-14 days||||<0.001
72608628|NCT02308046|144745848|SUPERIORITY||||||<|0.001|||||||Chi-squared, Corrected|||Comparison of culture cure at 21-30 days||||<0.001
72608629|NCT02308046|144745849|SUPERIORITY|||||||0.088|||||||Chi-squared, Corrected|||Comparison of the number of subjects whose reported their symptoms completely resolved||||0.088
72608630|NCT00526474|144745896|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.88||||0.001|TWO_SIDED|95.0|0.82|0.95|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio \<1 would indicate a lower hazard associated with vorapaxar relative to placebo.|||0.95|0.82|0.001
72417327|NCT02130193|144345281|SUPERIORITY_OR_OTHER||Posterior mean difference|-1.31|STANDARD_DEVIATION|2.42||0.24|TWO_SIDED|95.0|-6.46|3.05||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -3 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 6 month. Data presented are for 95% equal-tailed credible intervals|||3.05|-6.46|0.24
72417328|NCT02130193|144345281|SUPERIORITY_OR_OTHER||Posterior mean difference|-1.6|STANDARD_DEVIATION|2.45||0.29|TWO_SIDED|95.0|-6.75|2.9||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -3 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 7 month. Data presented are for 95% equal-tailed credible intervals|||2.90|-6.75|0.29
72417329|NCT02130193|144345281|SUPERIORITY_OR_OTHER||Posterior mean difference|-2.1|STANDARD_DEVIATION|2.63||0.36|TWO_SIDED|95.0|-6.93|3.3||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -3 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 8 month. Data presented are for 95% equal-tailed credible intervals|||3.30|-6.93|0.36
72608631|NCT00526474|144745897|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.87|||<|0.001|TWO_SIDED|95.0|0.8|0.94|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio \<1 would indicate a lower hazard associated with vorapaxar relative to placebo.|||0.94|0.80|<0.001
72608632|NCT00526474|144745898|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.51|||<|0.001|TWO_SIDED|95.0|1.31|1.74|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio \<1 would indicate a lower hazard associated with vorapaxar relative to placebo.|||1.74|1.31|<0.001
72608633|NCT00526474|144745899|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.41|||<|0.001|TWO_SIDED|95.0|1.31|1.51|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio \<1 would indicate a lower hazard associated with vorapaxar relative to placebo.|||1.51|1.31|<0.001
72608634|NCT00526474|144745900|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.91||||0.009|TWO_SIDED|95.0|0.85|0.98|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio \<1 would indicate a lower hazard associated with vorapaxar relative to placebo.|||0.98|0.85|0.009
72608635|NCT00526474|144745901|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.86||||0.002|TWO_SIDED|95.0|0.78|0.94|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio \<1 would indicate a lower hazard associated with vorapaxar relative to placebo.|||0.94|0.78|0.002
72608636|NCT00526474|144745902|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.87|||<|0.001|TWO_SIDED|95.0|0.81|0.93|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio \<1 would indicate a lower hazard associated with vorapaxar relative to placebo.|||0.93|0.81|<0.001
72608637|NCT00526474|144745903|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.91||||0.001|TWO_SIDED|95.0|0.86|0.96|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio \<1 would indicate a lower hazard associated with vorapaxar relative to placebo.|||0.96|0.86|0.001
72417330|NCT02130193|144345281|SUPERIORITY_OR_OTHER||Posterior mean difference|-1.92|STANDARD_DEVIATION|2.63||0.35|TWO_SIDED|95.0|-7.04|3.18||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -3 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 9 month. Data presented are for 95% equal-tailed credible intervals|||3.18|-7.04|0.35
72417331|NCT02130193|144345281|SUPERIORITY_OR_OTHER||Posterior mean difference|-3.44|STANDARD_DEVIATION|2.72||0.57|TWO_SIDED|95.0|-8.74|1.87||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -3 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 10 month. Data presented are for 95% equal-tailed credible intervals|||1.87|-8.74|0.57
72417332|NCT02130193|144345281|SUPERIORITY_OR_OTHER||Posterior mean difference|-1.16|STANDARD_DEVIATION|2.72||0.25|TWO_SIDED|95.0|-6.2|4.2||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -3 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 11 month. Data presented are for 95% equal-tailed credible intervals|||4.20|-6.20|0.25
72417333|NCT02130193|144345281|SUPERIORITY_OR_OTHER||Posterior mean difference|-1.73|STANDARD_DEVIATION|2.7||0.32|TWO_SIDED|95.0|-6.91|3.45||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -3 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 12 month. Data presented are for 95% equal-tailed credible intervals|||3.45|-6.91|0.32
72417334|NCT02130193|144345282|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.07||||0.477|TWO_SIDED|95.0|0.55|1.82||Posterior probability that the treatment ratio (DNX 75 mg/ placebo) is less than 1.0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|Data presented are for 95% equal-tailed credible intervals|||1.82|0.55|0.477
72417335|NCT02130193|144345282|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.07||||0.343|TWO_SIDED|95.0|0.55|1.82||Posterior probability that the treatment ratio (DNX 75 mg/ placebo) is less than 0.9 is presented.|Bayesian analysis|P-value is actually a posterior probability.|Data presented are for 95% equal-tailed credible intervals|||1.82|0.55|0.343
72417336|NCT02130193|144345282|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.07||||0.221|TWO_SIDED|95.0|0.55|1.82||Posterior probability that the treatment ratio (DNX 75 mg/ placebo) is less than 0.8 is presented.|Bayesian analysis|P-value is actually a posterior probability.|Data presented are for 95% equal-tailed credible intervals|||1.82|0.55|0.221
72417337|NCT02130193|144345282|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.07||||0.116|TWO_SIDED|95.0|0.55|1.82||Posterior probability that the treatment ratio (DNX 75 mg/ placebo) is less than 0.7 is presented.|Bayesian analysis|P-value is actually a posterior probability.|Data presented are for 95% equal-tailed credible intervals|||1.82|0.55|0.116
72417338|NCT02130193|144345282|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.07||||0.052|TWO_SIDED|95.0|0.55|1.82||Posterior probability that the treatment ratio (DNX 75 mg/ placebo) is less than 0.6 is presented.|Bayesian analysis|P-value is actually a posterior probability.|Data presented are for 95% equal-tailed credible intervals|||1.82|0.55|0.052
72417339|NCT02130193|144345283|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.32||||0.212|TWO_SIDED|95.0|0.73|2.11||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 1.0 is presented.|Bayesian Cox analysis|P-value is actually a posterior probability.|Data presented are for 95% equal-tailed credible intervals|||2.11|0.73|0.212
72417340|NCT02130193|144345283|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.32||||0.111|TWO_SIDED|95.0|0.73|2.11||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0.9 is presented.|Bayesian Cox analysis|P-value is actually a posterior probability.|Data presented are for 95% equal-tailed credible intervals|||2.11|0.73|0.111
72417341|NCT02130193|144345283|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.32||||0.049|TWO_SIDED|95.0|0.73|2.11||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0.8 is presented.|Bayesian Cox analysis|P-value is actually a posterior probability.|Data presented are for 95% equal-tailed credible intervals|||2.11|0.73|0.049
72417342|NCT02130193|144345283|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.32||||0.012|TWO_SIDED|95.0|0.73|2.11||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0.7 is presented.|Bayesian Cox analysis|P-value is actually a posterior probability.|Data presented are for 95% equal-tailed credible intervals|||2.11|0.73|0.012
72608638|NCT00526474|144745904|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.9|||<|0.001|TWO_SIDED|95.0|0.85|0.95|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio \<1 would indicate a lower hazard associated with vorapaxar relative to placebo.|||0.95|0.85|<0.001
72417343|NCT02130193|144345283|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.32||||0.001|TWO_SIDED|95.0|0.73|2.11||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0.6 is presented.|Bayesian Cox analysis|P-value is actually a posterior probability.|Data presented are for 95% equal-tailed credible intervals|||2.11|0.73|0.001
72417344|NCT02130193|144345286|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.23|STANDARD_DEVIATION|0.72||0.64|TWO_SIDED|95.0|-1.53|1.25||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-breath, 1 month. Data presented are for 95% equal-tailed credible intervals|||1.25|-1.53|0.64
72417345|NCT02130193|144345286|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.53|STANDARD_DEVIATION|0.78||0.75|TWO_SIDED|95.0|-1.91|1.1||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-breath, 2 month. Data presented are for 95% equal-tailed credible intervals|||1.10|-1.91|0.75
72417346|NCT02130193|144345286|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.6|STANDARD_DEVIATION|0.8||0.77|TWO_SIDED|95.0|-2.09|0.98||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-breath, 3 month. Data presented are for 95% equal-tailed credible intervals|||0.98|-2.09|0.77
72417347|NCT02130193|144345286|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.55|STANDARD_DEVIATION|0.81||0.74|TWO_SIDED|95.0|-2.23|0.87||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-breath, 4 month. Data presented are for 95% equal-tailed credible intervals|||0.87|-2.23|0.74
72417348|NCT02130193|144345286|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.36|STANDARD_DEVIATION|0.83||0.67|TWO_SIDED|95.0|-1.88|1.27||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-breath, 5 month. Data presented are for 95% equal-tailed credible intervals|||1.27|-1.88|0.67
72417349|NCT02130193|144345286|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.43|STANDARD_DEVIATION|0.86||0.69|TWO_SIDED|95.0|-1.99|1.26||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-breath, 6 month. Data presented are for 95% equal-tailed credible intervals|||1.26|-1.99|0.69
72417350|NCT02130193|144345286|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.5|STANDARD_DEVIATION|0.85||0.72|TWO_SIDED|95.0|-2.1|1.08||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-breath, 7 month. Data presented are for 95% equal-tailed credible intervals|||1.08|-2.10|0.72
72417351|NCT02130193|144345286|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.5|STANDARD_DEVIATION|0.87||0.71|TWO_SIDED|95.0|-2.11|1.14||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-breath, 8 month. Data presented are for 95% equal-tailed credible intervals|||1.14|-2.11|0.71
72417352|NCT02130193|144345286|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.34|STANDARD_DEVIATION|0.88||0.66|TWO_SIDED|95.0|-2.14|1.23||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-breath, 9 month. Data presented are for 95% equal-tailed credible intervals|||1.23|-2.14|0.66
72608639|NCT00526474|144745905|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.89||||0.151|TWO_SIDED|95.0|0.76|1.04|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio \<1 would indicate a lower hazard associated with vorapaxar relative to placebo.|||1.04|0.76|0.151
72608640|NCT00526474|144745906|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.83||||0.001|TWO_SIDED|95.0|0.74|0.93|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio \<1 would indicate a lower hazard associated with vorapaxar relative to placebo.|||0.93|0.74|0.001
72608641|NCT00526474|144745907|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.88||||0.108|TWO_SIDED|95.0|0.75|1.03|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio \<1 would indicate a lower hazard associated with vorapaxar relative to placebo.|||1.03|0.75|0.108
72608642|NCT00526474|144745908|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.97||||0.733|TWO_SIDED|95.0|0.83|1.14|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio \<1 would indicate a lower hazard associated with vorapaxar relative to placebo.|||1.14|0.83|0.733
72608643|NCT00526474|144745909|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.95||||0.411|TWO_SIDED|95.0|0.85|1.07|||Cox Proportional Hazards Regression||Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio \<1 would indicate a lower hazard associated with vorapaxar relative to placebo.|||1.07|0.85|0.411
72608644|NCT00526474|144745910|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.83||||0.001|TWO_SIDED|95.0|0.74|0.93|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio \<1 would indicate a lower hazard associated with vorapaxar relative to placebo.|||0.93|0.74|0.001
72608645|NCT00526474|144745911|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.89|||<|0.001|TWO_SIDED|95.0|0.83|0.95|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio \<1 would indicate a lower hazard associated with vorapaxar relative to placebo.|||0.95|0.83|<0.001
72608646|NCT00526474|144745912|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.83|||<|0.001|TWO_SIDED|95.0|0.76|0.9|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio \<1 would indicate a lower hazard associated with vorapaxar relative to placebo.|||0.90|0.76|<0.001
72608647|NCT00526474|144745913|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.8|||<|0.001|TWO_SIDED|95.0|0.73|0.89|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio \<1 would indicate a lower hazard associated with vorapaxar relative to placebo.|||0.89|0.73|<0.001
72608648|NCT00526474|144745914|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.45|||<|0.001|TWO_SIDED|95.0|1.23|1.71|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio \<1 would indicate a lower hazard associated with vorapaxar relative to placebo.|||1.71|1.23|<0.001
72608649|NCT00526474|144745915|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.42|||<|0.001|TWO_SIDED|95.0|1.31|1.54|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio \<1 would indicate a lower hazard associated with vorapaxar relative to placebo.|||1.54|1.31|<0.001
72608650|NCT00526474|144745916|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.86|||<|0.001|TWO_SIDED|95.0|0.79|0.93|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio \<1 would indicate a lower hazard associated with vorapaxar relative to placebo.|||0.93|0.79|<0.001
72608651|NCT00526474|144745917|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.83|||<|0.001|TWO_SIDED|95.0|0.75|0.93|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio \<1 would indicate a lower hazard associated with vorapaxar relative to placebo.|||0.93|0.75|<0.001
72608652|NCT00526474|144745918|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.83|||<|0.001|TWO_SIDED|95.0|0.77|0.9|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio \<1 would indicate a lower hazard associated with vorapaxar relative to placebo.|||0.90|0.77|<0.001
72608653|NCT00526474|144745919|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.89|||<|0.001|TWO_SIDED|95.0|0.83|0.95|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio \<1 would indicate a lower hazard associated with vorapaxar relative to placebo.|||0.95|0.83|<0.001
72608654|NCT00526474|144745920|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.88|||<|0.001|TWO_SIDED|95.0|0.83|0.94|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio \<1 would indicate a lower hazard associated with vorapaxar relative to placebo.|||0.94|0.83|<0.001
72608655|NCT00526474|144745921|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.86||||0.108|TWO_SIDED|95.0|0.71|1.03|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio \<1 would indicate a lower hazard associated with vorapaxar relative to placebo.|||1.03|0.71|0.108
72608656|NCT00526474|144745922|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.82||||0.002|TWO_SIDED|95.0|0.73|0.93|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio \<1 would indicate a lower hazard associated with vorapaxar relative to placebo.|||0.93|0.73|0.002
72608657|NCT00526474|144745923|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.88||||0.127|TWO_SIDED|95.0|0.74|1.04|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio \<1 would indicate a lower hazard associated with vorapaxar relative to placebo.|||1.04|0.74|0.127
72608658|NCT00526474|144745924|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.67||||0.002|TWO_SIDED|95.0|0.52|0.87|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio \<1 would indicate a lower hazard associated with vorapaxar relative to placebo.|||0.87|0.52|0.002
72608659|NCT00526474|144745925|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.92||||0.249|TWO_SIDED|95.0|0.8|1.06|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio \<1 would indicate a lower hazard associated with vorapaxar relative to placebo.|||1.06|0.80|0.249
72608660|NCT00526474|144745926|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.86||||0.019|TWO_SIDED|95.0|0.76|0.98|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio \<1 would indicate a lower hazard associated with vorapaxar relative to placebo.|||0.98|0.76|0.019
72608661|NCT00526474|144745927|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.89||||0.003|TWO_SIDED|95.0|0.83|0.96|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio \<1 would indicate a lower hazard associated with vorapaxar relative to placebo.|||0.96|0.83|0.003
72608662|NCT01587885|144745928|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.548|||<|0.048|||||||Regression, Cox|||||||<0.0480
72608663|NCT00752089|144745937|SUPERIORITY_OR_OTHER||Adjusted mean difference|1.146||||0.7756|TWO_SIDED|95.0|-6.904|9.196||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANOVA|The model included treatment and period as fixed and participant as random factors.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments. Tests were 2-sided.||9.196|-6.904|0.7756
72608664|NCT00752089|144745937|SUPERIORITY_OR_OTHER||Adjusted mean difference|3.291||||0.4194|TWO_SIDED|95.0|-4.84|11.421||No adjustments for multiple comparisons were made as the primary comparison was pre-defined.|ANOVA|The model included treatment and period as fixed and participant as random factors.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments. Tests were 2-sided.||11.421|-4.840|0.4194
72608665|NCT00752089|144745937|SUPERIORITY_OR_OTHER||Adjusted mean difference|22.2|||<|0.0001|TWO_SIDED|95.0|14.28|30.12||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANOVA|The model included treatment and period as fixed and participant as random factors.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments. Tests were 2-sided.||30.120|14.280|<0.0001
72608666|NCT00752089|144745937|SUPERIORITY_OR_OTHER||Adjusted mean difference|2.145||||0.5927|TWO_SIDED|95.0|-5.874|10.164||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANOVA|The model included treatment and period as fixed and participant as random factors.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments. Tests were 2-sided.||10.164|-5.874|0.5927
72608667|NCT00752089|144745937|SUPERIORITY_OR_OTHER||Adjusted mean difference|21.054|||<|0.0001|TWO_SIDED|95.0|13.189|28.919||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANOVA|The model included treatment and period as fixed and participant as random factors.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments. Tests were 2-sided.||28.919|13.189|<0.0001
72608668|NCT00752089|144745937|SUPERIORITY_OR_OTHER||Adjusted mean difference|18.909|||<|0.0001|TWO_SIDED|95.0|11.036|26.783||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANOVA|The model included treatment and period as fixed and participant as random factors.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments. Tests were 2-sided.||26.783|11.036|<0.0001
72608669|NCT00752089|144745938|SUPERIORITY_OR_OTHER||Adjusted mean difference|-321.438||||0.199|TWO_SIDED|95.0|-818.118|175.242||No adjustments for multiple comparisons were made as the primary comparison was pre-defined.|ANOVA|The model included treatment and period as fixed and participant as random factors.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments. Tests were 2-sided.||175.242|-818.118|0.1990
72608670|NCT00752089|144745938|SUPERIORITY_OR_OTHER||Adjusted mean difference|-72.68||||0.7718||95.0|-574.398|429.039||No adjustments for multiple comparisons were made as the primary comparison was pre-defined.|ANOVA|The model included treatment and period as fixed and participant as random factors.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments. Tests were 2-sided.||429.039|-574.398|0.7718
72608671|NCT00752089|144745938|SUPERIORITY_OR_OTHER||Adjusted mean difference|1784.675|||<|0.0001||95.0|1296.044|2273.306||No adjustments for multiple comparisons were made as the primary comparison was pre-defined.|ANOVA|The model included treatment and period as fixed and participant as random factors.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments. Tests were 2-sided.||2273.306|1296.044|<0.0001
72608672|NCT00752089|144745938|SUPERIORITY_OR_OTHER||Adjusted mean difference|248.758||||0.3164||95.0|-245.962|743.478||No adjustments for multiple comparisons were made as the primary comparison was pre-defined.|ANOVA|The model included tratment and period as fixed and participant as random factors.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments. Tests were 2-sided.||743.478|-245.962|0.3164
72417353|NCT02130193|144345286|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.89|STANDARD_DEVIATION|0.89||0.84|TWO_SIDED|95.0|-2.71|0.69||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-breath, 10 month. Data presented are for 95% equal-tailed credible intervals|||0.69|-2.71|0.84
72417354|NCT02130193|144345286|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.36|STANDARD_DEVIATION|0.91||0.65|TWO_SIDED|95.0|-2.15|1.41||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-breath, 11 month. Data presented are for 95% equal-tailed credible intervals|||1.41|-2.15|0.65
72417355|NCT02130193|144345286|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.49|STANDARD_DEVIATION|0.9||0.71|TWO_SIDED|95.0|-2.36|1.13||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-breath, 12 month. Data presented are for 95% equal-tailed credible intervals|||1.13|-2.36|0.71
72417356|NCT02130193|144345286|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.23|STANDARD_DEVIATION|0.72||0.13|TWO_SIDED|95.0|-1.53|1.25||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -1 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-breath, 1 month. Data presented are for 95% equal-tailed credible intervals|||1.25|-1.53|0.13
72417357|NCT02130193|144345286|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.53|STANDARD_DEVIATION|0.78||0.27|TWO_SIDED|95.0|-1.91|1.1||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -1 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-breath, 2 month. Data presented are for 95% equal-tailed credible intervals|||1.10|-1.91|0.27
72417358|NCT02130193|144345286|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.6|STANDARD_DEVIATION|0.8||0.31|TWO_SIDED|95.0|-2.09|0.98||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -1 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-breath, 3 month. Data presented are for 95% equal-tailed credible intervals|||0.98|-2.09|0.31
72417359|NCT02130193|144345286|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.55|STANDARD_DEVIATION|0.81||0.29|TWO_SIDED|95.0|-2.23|0.87||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -1 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-breath, 4 month. Data presented are for 95% equal-tailed credible intervals|||0.87|-2.23|0.29
72417360|NCT02130193|144345286|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.36|STANDARD_DEVIATION|0.83||0.23|TWO_SIDED|95.0|-1.88|1.27||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -1 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-breath, 5 month. Data presented are for 95% equal-tailed credible intervals|||1.27|-1.88|0.23
72417361|NCT02130193|144345286|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.43|STANDARD_DEVIATION|0.86||0.26|TWO_SIDED|95.0|-1.99|1.26||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -1 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-breath, 6 month. Data presented are for 95% equal-tailed credible intervals|||1.26|-1.99|0.26
72417362|NCT02130193|144345286|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.5|STANDARD_DEVIATION|0.85||0.28|TWO_SIDED|95.0|-2.1|1.08||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -1 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-breath, 7 month. Data presented are for 95% equal-tailed credible intervals|||1.08|-2.10|0.28
72417363|NCT02130193|144345286|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.5|STANDARD_DEVIATION|0.87||0.29|TWO_SIDED|95.0|-2.11|1.14||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -1 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-breath, 8 month. Data presented are for 95% equal-tailed credible intervals|||1.14|-2.11|0.29
72417364|NCT02130193|144345286|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.34|STANDARD_DEVIATION|0.88||0.23|TWO_SIDED|95.0|-2.14|1.23||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -1 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-breath, 9 month. Data presented are for 95% equal-tailed credible intervals|||1.23|-2.14|0.23
72417365|NCT02130193|144345286|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.89|STANDARD_DEVIATION|0.89||0.45|TWO_SIDED|95.0|-2.71|0.69||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -1 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-breath, 10 month. Data presented are for 95% equal-tailed credible intervals|||0.69|-2.71|0.45
72417366|NCT02130193|144345286|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.36|STANDARD_DEVIATION|0.91||0.24|TWO_SIDED|95.0|-2.15|1.41||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -1 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-breath, 11 month. Data presented are for 95% equal-tailed credible intervals|||1.41|-2.15|0.24
72608673|NCT00752089|144745938|SUPERIORITY_OR_OTHER||Adjusted mean difference|2106.113|||<|0.0001|TWO_SIDED|95.0|1620.906|2591.32||No adjustments for multiple comparisons were made as the primary comparison was pre-defined.|ANOVA|The model included treatment and period as fixed and participant as random factors.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments. Tests were 2-sided.||2591.320|1620.906|<0.0001
72417367|NCT02130193|144345286|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.49|STANDARD_DEVIATION|0.9||0.28|TWO_SIDED|95.0|-2.36|1.13||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -1 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-breath, 12 month. Data presented are for 95% equal-tailed credible intervals|||1.13|-2.36|0.28
72417368|NCT02130193|144345286|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.23|STANDARD_DEVIATION|0.72||0.26|TWO_SIDED|95.0|-1.53|1.25||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -0.7 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-breath, 1 month. Data presented are for 95% equal-tailed credible intervals|||1.25|-1.53|0.26
72608674|NCT00752089|144745938|SUPERIORITY_OR_OTHER||Adjusted mean difference|1857.355|||<|0.0001|TWO_SIDED|95.0|1371.637|2343.072||No adjustments for multiple comparisons were made as the primary comparison was pre-defined.|ANOVA|The model included treatment and period and fixed and participant as random factors.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments. Tests were 2-sided.||2343.072|1371.637|<0.0001
72417369|NCT02130193|144345286|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.53|STANDARD_DEVIATION|0.78||0.41|TWO_SIDED|95.0|-1.91|1.1||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -0.7 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-breath, 2 month. Data presented are for 95% equal-tailed credible intervals|||1.10|-1.91|0.41
72417370|NCT02130193|144345286|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.6|STANDARD_DEVIATION|0.8||0.46|TWO_SIDED|95.0|-2.09|0.98||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -0.7 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-breath, 3 month. Data presented are for 95% equal-tailed credible intervals|||0.98|-2.09|0.46
72417371|NCT02130193|144345286|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.55|STANDARD_DEVIATION|0.81||0.43|TWO_SIDED|95.0|-2.23|0.87||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -0.7 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-breath, 4 month. Data presented are for 95% equal-tailed credible intervals|||0.87|-2.23|0.43
72417372|NCT02130193|144345286|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.36|STANDARD_DEVIATION|0.83||0.36|TWO_SIDED|95.0|-1.88|1.27||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -0.7 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-breath, 5 month. Data presented are for 95% equal-tailed credible intervals|||1.27|-1.88|0.36
72417373|NCT02130193|144345286|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.43|STANDARD_DEVIATION|0.86||0.39|TWO_SIDED|95.0|-1.99|1.26||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -0.7 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-breath, 6 month. Data presented are for 95% equal-tailed credible intervals|||1.26|-1.99|0.39
72325501|NCT03937479|144174466|SUPERIORITY||LS mean difference|0.1242|STANDARD_ERROR_OF_MEAN|0.03691||0.0008|TWO_SIDED|95.0|0.0517|0.1968||The mixed model for repeated measures (MMRM) model was used to model the change from baseline FEV1 to peak FEV1 using treatment, visit and treatment by visit interaction as fixed effect, patient as random effect and baseline FEV1 as the covariate.|MMRM||Estimates refer to the Week 4 from treatment by visit interaction.|Comparison was done using a closed testing procedure; testing began at the highest dose of RPL554 compared with placebo. If found statistically significant then the next highest dose was compared with placebo. This continued until a result was found to be non-significant or all RPL554 doses were compared with placebo.||0.1968|0.0517|0.0008
72608675|NCT00975416|144745956|SUPERIORITY_OR_OTHER|||||||0.927|TWO_SIDED||||||ANOVA|||Repeated measures ANOVA to deterimine whether oxytocin increased compared to placebo measures of therapeutic alliance (as measured by the Helping alliance questionnaire) pre compared to post 12 sessions of CBT.||||0.927
72325502|NCT03937479|144174466|SUPERIORITY||LS mean difference|0.1072|STANDARD_ERROR_OF_MEAN|0.03703||0.004|TWO_SIDED|95.0|0.0344|0.18||The MMRM model was used to model the change from baseline FEV1 to peak FEV1 using treatment, visit and treatment by visit interaction as fixed effect, patient as random effect and baseline FEV1 as the covariate.|MMRM||Estimates refer to the Week 4 from treatment by visit interaction.|Comparison was done using a closed testing procedure; testing began at the highest dose of RPL554 compared with placebo. If found statistically significant then the next highest dose was compared with placebo. This continued until a result was found to be non-significant or all RPL554 doses were compared with placebo.||0.1800|0.0344|0.0040
72417374|NCT02130193|144345286|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.5|STANDARD_DEVIATION|0.85||0.42|TWO_SIDED|95.0|-2.1|1.08||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -0.7 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-breath, 7 month. Data presented are for 95% equal-tailed credible intervals|||1.08|-2.10|0.42
72608676|NCT00975416|144745956|SUPERIORITY_OR_OTHER|||||||0.6|TWO_SIDED||||||ANOVA|||Repeated measures anova to determine if oxytocin compared to placebo increased therpeutic alliance as measured by the working alliance inventory after 12 sessions of CBT.||||0.60
72608677|NCT01249131|144745972|SUPERIORITY_OR_OTHER||Ratio of Least Squares (LS) Means (in %)|94.7|||||TWO_SIDED|90.0|83.9|107.0|||||LS mean was calculated from analysis of variance (ANOVA). Data for dose-normalized AUCinf were natural log-transformed prior to analysis. Ratio of AUCinf LS means for log-transformed parameter (expressed as a percent).|||107|83.9|
72608678|NCT01249131|144745972|SUPERIORITY_OR_OTHER||Ratio of LS Means (in %)|110.0|||||TWO_SIDED|90.0|98.2|124.0|||||LS mean was calculated from ANOVA. Data for dose-normalized AUCinf were natural log-transformed prior to analysis. Ratio of AUCinf LS means for log-transformed parameter (expressed as a percent).|||124|98.2|
72608679|NCT01249131|144745973|SUPERIORITY_OR_OTHER||Ratio of LS Means (in %)|96.9|||||TWO_SIDED|90.0|84.2|111.0|||||LS mean was calculated from ANOVA. Data for dose-normalized Cmax were natural log-transformed prior to analysis. Ratio of Cmax LS means for log-transformed parameter (expressed as a percent).|||111|84.2|
72608680|NCT01249131|144745973|SUPERIORITY_OR_OTHER||Ratio of LS Means (in %)|107.0|||||TWO_SIDED|90.0|93.8|123.0|||||LS mean was calculated from ANOVA. Data for dose-normalized Cmax were natural log-transformed prior to analysis. Ratio of Cmax LS means for log-transformed parameter (expressed as a percent).|||123|93.8|
72608681|NCT03555149|144745982|OTHER||Difference in Overall Response Rate|6.67|||||TWO_SIDED|95.0|-11.92|25.25|||||The difference in ORR was calculated as the experimental arm (Atezolizumab + Regorafenib) subtracted from the control arm (Regorafenib).|||25.25|-11.92|
72608682|NCT03555149|144745982|OTHER||Difference in Overall Response Rate|6.67|||||TWO_SIDED|95.0|-11.92|25.25|||||The difference in ORR was calculated as the experimental arm (Atezolizumab + Regorafenib + AB928) subtracted from the control arm (Regorafenib).|||25.25|-11.92|
72608683|NCT03555149|144745983|OTHER||Hazard Ratio (HR)|1.35|||||TWO_SIDED|95.0|0.67|2.73||||||||2.73|0.67|
72608684|NCT03555149|144745983|OTHER||Hazard Ratio (HR)|2.3|||||TWO_SIDED|95.0|1.08|4.88||||||||4.88|1.08|
72608685|NCT03555149|144745983|OTHER||Hazard Ratio (HR)|0.79|||||TWO_SIDED|95.0|0.29|2.18||||||||2.18|0.29|
72608686|NCT03555149|144745983|OTHER||Hazard Ratio (HR)|2.0|||||TWO_SIDED|95.0|0.64|6.24||||||||6.24|0.64|
72608687|NCT03555149|144745983|OTHER||Hazard Ratio (HR)|1.74|||||TWO_SIDED|95.0|0.83|3.63||||||||3.63|0.83|
72608688|NCT03555149|144745983|OTHER||Hazard Ratio (HR)|0.8|||||TWO_SIDED|95.0|0.39|1.63||||||||1.63|0.39|
72608689|NCT03555149|144745983|OTHER||Hazard Ratio (HR)|5.64|||||TWO_SIDED|95.0|0.94|33.82||||||||33.82|0.94|
72608690|NCT03555149|144745984|OTHER|Kaplan-Meier|Hazard Ratio (HR)|1.44|||||TWO_SIDED|95.0|0.71|2.93||||||Atezolizumab + Imprime PGG + Bevacizumab vs. Regorafenib (Control) Hazard Ratio for OS||2.93|0.71|
72608691|NCT03555149|144745984|OTHER|Kaplan-Meier|Hazard Ratio (HR)|1.38|||||TWO_SIDED|95.0|0.68|2.81||||||Atezolizumab + Isatuximab vs. Regorafenib (Control) Hazard Ratio for OS||2.81|0.68|
72608692|NCT03555149|144745984|OTHER|Kaplan-Meier|Hazard Ratio (HR)|0.9|||||TWO_SIDED|95.0|0.3|2.72||||||Atezolizumab + Selicrelumab + Bevacizumab vs. Regorafenib (Control) Hazard Ratio for OS||2.72|0.30|
72608693|NCT03555149|144745984|OTHER|Kaplan-Meier|Hazard Ratio (HR)|1.27|||||TWO_SIDED|95.0|0.42|3.84||||||Atezolizumab + Idasanutlin vs. Regorafenib (Control) Hazard Ratio for OS||3.84|0.42|
72608694|NCT03555149|144745984|OTHER|Kaplan-Meier|Hazard Ratio (HR)|0.86|||||TWO_SIDED|95.0|0.39|1.88||||||Atezolizumab + Regorafenib vs. Regorafenib (Control) Hazard Ratio for OS||1.88|0.39|
72608695|NCT03555149|144745984|OTHER|Kaplan-Meier|Hazard Ratio (HR)|0.92|||||TWO_SIDED|95.0|0.43|1.96||||||Atezolizumab + Regorafenib + AB928 vs. Regorafenib (Control) Hazard Ratio for OS||1.96|0.43|
72608696|NCT03555149|144745984|OTHER|Kaplan-Meier|Hazard Ratio (HR)|2.88|||||TWO_SIDED|95.0|0.33|24.85||||||Atezolizumab + LOAd703 vs. Regorafenib (Control) Hazard Ratio for OS||24.85|0.33|
72608697|NCT03555149|144745985|OTHER||Difference in OS Event-Free Rate|15.79|||||TWO_SIDED|95.0|-0.61|32.19||||||Difference in OS event-free rate at 3 months for the Atezolizumab + Imprime PGG + Bevacizumab vs. Regorafenib (Control) arms||32.19|-0.61|
72608698|NCT03555149|144745985|OTHER||Difference in OS Event-Free Rate|-16.49|||||TWO_SIDED|95.0|-49.78|16.79||||||Difference in OS event-free rate at 6 months for the Atezolizumab + Imprime PGG + Bevacizumab vs. Regorafenib (Control) arms||16.79|-49.78|
72608699|NCT03555149|144745985|OTHER||Difference in OS Event-Free Rate|-14.45|||||TWO_SIDED|95.0|-44.37|15.47||||||Difference in OS event-free rate at 12 months for the Atezolizumab + Imprime PGG + Bevacizumab vs. Regorafenib (Control) arms||15.47|-44.37|
72608700|NCT03555149|144745985|OTHER||Difference in OS Event-Free Rate|-10.56|||||TWO_SIDED|95.0|-32.25|11.14||||||Difference in OS event-free rate at 18 months for the Atezolizumab + Imprime PGG + Bevacizumab vs. Regorafenib (Control) arms||11.14|-32.25|
72608701|NCT03555149|144745985|OTHER||Difference in OS Event-Free Rate|-10.88|||||TWO_SIDED|95.0|-38.62|16.87||||||Difference in OS event-free rate at 3 months for the Atezolizumab + Isatuximab vs. Regorafenib (Control) arms||16.87|-38.62|
72608702|NCT03555149|144745985|OTHER||Difference in OS Event-Free Rate|-23.16|||||TWO_SIDED|95.0|-56.1|9.78||||||Difference in OS event-free rate at 6 months for the Atezolizumab + Isatuximab vs. Regorafenib (Control) arms||9.78|-56.10|
72608703|NCT03555149|144745985|OTHER||Difference in OS Event-Free Rate|-7.78|||||TWO_SIDED|95.0|-39.19|23.62||||||Difference in OS event-free rate at 12 months for the Atezolizumab + Isatuximab vs. Regorafenib (Control) arms||23.62|-39.19|
72608704|NCT03555149|144745985|OTHER||Difference in OS Event-Free Rate|2.78|||||TWO_SIDED|95.0|-24.08|29.63||||||Difference in OS event-free rate at 18 months for the Atezolizumab + Isatuximab vs. Regorafenib (Control) arms||29.63|-24.08|
72608705|NCT03555149|144745985|OTHER||Difference in OS Event-Free Rate|15.79|||||TWO_SIDED|95.0|-0.61|32.19||||||Difference in OS event-free rate at 3 months for the Atezolizumab + Selicrelumab + Bevacizumab vs. Regorafenib (Control) arms||32.19|-0.61|
72608706|NCT03555149|144745985|OTHER||Difference in OS Event-Free Rate|16.84|||||TWO_SIDED|95.0|-24.39|58.07||||||Difference in OS event-free rate at 6 months for the Atezolizumab + Selicrelumab + Bevacizumab vs. Regorafenib (Control) arms||58.07|-24.39|
72608707|NCT03555149|144745985|OTHER||Difference in OS Event-Free Rate|18.88|||||TWO_SIDED|95.0|-34.53|72.3||||||Difference in OS event-free rate at 12 months for the Atezolizumab + Selicrelumab + Bevacizumab vs. Regorafenib (Control) arms||72.30|-34.53|
72608708|NCT03555149|144745985|OTHER||Difference in OS Event-Free Rate|9.44|||||TWO_SIDED|95.0|-38.19|57.08||||||Difference in OS event-free rate at 18 months for the Atezolizumab + Selicrelumab + Bevacizumab vs. Regorafenib (Control) arms||57.08|-38.19|
72608709|NCT03555149|144745985|OTHER||Difference in OS Event-Free Rate|-9.21|||||TWO_SIDED|95.0|-54.7|36.28||||||Difference in OS event-free rate at 3 months for the Atezolizumab + Idasanutlin vs. Regorafenib (Control) arms||36.28|-54.70|
72608710|NCT03555149|144745985|OTHER||Difference in OS Event-Free Rate|-13.16|||||TWO_SIDED|95.0|-66.74|40.43||||||Difference in OS event-free rate at 6 months for the Atezolizumab + Idasanutlin vs. Regorafenib (Control) arms||40.43|-66.74|
72608711|NCT03555149|144745985|OTHER||Difference in OS Event-Free Rate|-9.45|||||TWO_SIDED|95.0|-57.26|38.36||||||Difference in OS event-free rate at 12 months for the Atezolizumab + Idasanutlin vs. Regorafenib (Control) arms||38.36|-57.26|
72608712|NCT03555149|144745985|OTHER||Difference in OS Event-Free Rate|7.78|||||TWO_SIDED|95.0|-38.18|53.73||||||Difference in OS event-free rate at 18 months for the Atezolizumab + Idasanutlin vs. Regorafenib (Control) arms||53.73|-38.18|
72608713|NCT03555149|144745985|OTHER||Difference in OS Event-Free Rate|-5.24|||||TWO_SIDED|95.0|-32.03|21.56||||||Difference in OS event-free rate at 3 months for the Atezolizumab + Regorafenib vs. Regorafenib (Control) arms||21.56|-32.03|
72608714|NCT03555149|144745985|OTHER||Difference in OS Event-Free Rate|8.64|||||TWO_SIDED|95.0|-23.33|40.6||||||Difference in OS event-free rate at 6 months for the Atezolizumab + Regorafenib vs. Regorafenib (Control) arms||40.60|-23.33|
72608715|NCT03555149|144745985|OTHER||Difference in OS Event-Free Rate|5.44|||||TWO_SIDED|95.0|-29.19|40.06||||||Difference in OS event-free rate at 12 months for the Atezolizumab + Regorafenib vs. Regorafenib (Control) arms||40.06|-29.19|
72608716|NCT03555149|144745985|OTHER||Difference in OS Event-Free Rate|6.71|||||TWO_SIDED|95.0|-22.64|36.06||||||Difference in OS event-free rate at 18 months for the Atezolizumab + Regorafenib vs. Regorafenib (Control) arms||36.06|-22.64|
72608717|NCT03555149|144745985|OTHER||Difference in OS Event-Free Rate|2.46|||||TWO_SIDED|95.0|-21.31|26.22||||||Difference in OS event-free rate at 3 months for the Atezolizumab + Regorafenib + AB928 vs. Regorafenib (Control) arms||26.22|-21.31|
72608718|NCT03555149|144745985|OTHER||Difference in OS Event-Free Rate|10.18|||||TWO_SIDED|95.0|-20.99|41.34||||||Difference in OS event-free rate at 6 months for the Atezolizumab + Regorafenib + AB928 vs. Regorafenib (Control) arms||41.34|-20.99|
72608719|NCT03555149|144745985|OTHER||Difference in OS Event-Free Rate|-1.12|||||TWO_SIDED|95.0|-33.59|31.36||||||Difference in OS event-free rate at 12 months for the Atezolizumab + Regorafenib + AB928 vs. Regorafenib (Control) arms||31.36|-33.59|
72608720|NCT03555149|144745985|OTHER||Difference in OS Event-Free Rate|9.44|||||TWO_SIDED|95.0|-19.06|37.94||||||Difference in OS event-free rate at 18 months for the Atezolizumab + Regorafenib + AB928 vs. Regorafenib (Control) arms||37.94|-19.06|
72608721|NCT03555149|144745985|OTHER||Difference in OS Event-Free Rate|15.79|||||TWO_SIDED|95.0|-0.61|32.19||||||Difference in OS event-free rate at 3 months for the Atezolizumab +LOAd703 vs. Regorafenib (Control) arms||32.19|-0.61|
72608722|NCT01038687|144746013|SUPERIORITY|||||||0.059|||||||ANCOVA|||||||0.059
72608723|NCT01038687|144746013|SUPERIORITY|||||||0.18|||||||Dunnett's test|||15mg dose vs placebo||||0.18
72608724|NCT01038687|144746013|SUPERIORITY|||||||0.04|||||||Dunnett's test|||20mg dose vs placebo||||0.04
72608725|NCT01038687|144746014|SUPERIORITY|||||||0.81|||||||ANCOVA|||||||0.81
72608726|NCT01038687|144746014|SUPERIORITY|||||||0.89|||||||Dunnett's test|||15mg dose vs placebo||||0.89
72608727|NCT01038687|144746014|SUPERIORITY|||||||0.76|||||||Dunnett's test|||20mg dose vs placebo||||0.76
72608728|NCT01038687|144746015|SUPERIORITY|||||||0.075|||||||ANCOVA|||||||0.075
72608729|NCT01038687|144746015|SUPERIORITY|||||||0.058|||||||Dunnett's test|||15mg dose vs placebo||||0.058
72608730|NCT01038687|144746015|SUPERIORITY|||||||0.164|||||||Dunnett's test|||20mg dose vs placebo||||0.164
72608731|NCT01038687|144746016|SUPERIORITY|||||||0.084|||||||ANCOVA|||||||0.084
72608732|NCT01038687|144746016|SUPERIORITY|||||||0.98|||||||Dunnett's test|||15mg vs placebo||||0.98
72608733|NCT01038687|144746016|SUPERIORITY|||||||0.079|||||||Dunnett's test|||20mg vs placebo||||0.079
72608734|NCT01038687|144746017|SUPERIORITY|||||||0.058|||||||ANCOVA|||||||0.058
72608735|NCT01038687|144746017|SUPERIORITY|||||||0.32|||||||Dunnett's test|||15mg dose vs placebo||||0.32
72608736|NCT01038687|144746017|SUPERIORITY|||||||0.034|||||||Dunnett's test|||20mg dose vs placebo||||0.034
72608737|NCT01038687|144746018|SUPERIORITY|||||||0.001|||||||ANCOVA|||||||0.001
72608738|NCT01038687|144746018|SUPERIORITY|||||||0.002|||||||Dunnett's test|||15mg dose vs placebo||||0.002
72608739|NCT01038687|144746018|SUPERIORITY|||||||0.001|||||||Dunnett's test|||20mg vs placebo||||0.001
72608740|NCT01038687|144746019|SUPERIORITY|||||||0.091|||||||ANCOVA|||||||0.091
72608741|NCT01038687|144746019|SUPERIORITY|||||||0.99|||||||Dunnett's test|||15mg dose vs placebo||||0.99
72608742|NCT01038687|144746019|SUPERIORITY|||||||0.103|||||||Dunnett's test|||20mg vs placebo||||0.103
72608743|NCT01038687|144746020|SUPERIORITY|||||||0.001|||||||ANCOVA|||||||0.001
72608744|NCT01038687|144746020|SUPERIORITY|||||||0.002|||||||Dunnett's test|||15mg dose vs placebo||||0.002
72608745|NCT01038687|144746020|SUPERIORITY|||||||0.001|||||||Dunnett's test|||20mg dose vs placebo||||0.001
72608746|NCT01038687|144746021|SUPERIORITY|||||||0.002|||||||ANCOVA|||||||0.002
72608747|NCT01038687|144746021|SUPERIORITY|||||||0.053|||||||Dunnett's test|||15mg dose vs placebo||||0.053
72608748|NCT01038687|144746021|SUPERIORITY|||||||0.002|||||||Dunnett's test|||20mg dose vs placebo||||0.002
72608749|NCT05222880|144746036|SUPERIORITY|A superiority Margin of 0.00 logMAR was used for distance.|Mean Population Estimate|-0.1|STANDARD_ERROR_OF_MEAN|0.007|||TWO_SIDED|99.0|-0.12|-0.08||||||It was calculated using a 2-sided one sample mean t-test with a family wise type I error rate of 5% (1% Individually) with at least 99% statistical power, that 17 subjects were required to test the primary hypothesis for Distance.||-0.08|-0.12|
72608750|NCT05222880|144746036|SUPERIORITY|A superiority Margin of 0.17 logMAR was used for Intermediate.|Mean Population Estimate|-0.04|STANDARD_ERROR_OF_MEAN|0.007|||TWO_SIDED|99.0|-0.06|-0.02||||||It was calculated using a 2-sided one sample mean t-test with a family wise type I error rate of 5% (1% Individually) with at least 99% statistical power, that 11 subjects were required to test the primary hypothesis for Intermediate.||-0.02|-0.06|
72608751|NCT05222880|144746036|SUPERIORITY|A superiority Margin of 0.17 logMAR was used for near.|Mean Population Estimate|0.07|STANDARD_ERROR_OF_MEAN|0.009|||TWO_SIDED|99.0|0.05|0.09||||||It was calculated using a 2-sided one sample mean t-test with a family wise type I error rate of 5% (1% Individually) with at least 99% statistical power, that 48 subjects were required to test the primary hypothesis for Near.||0.09|0.05|
72608752|NCT05222880|144746037|SUPERIORITY|A superiority Margin of 36 CLUE Points was used for Hyperopes.|Mean Population Estimate|52.3|STANDARD_ERROR_OF_MEAN|2.75|||TWO_SIDED|99.0|45.2|59.4||||||It was calculated using a 2-sided one sample mean t-test with a family wise type I error rate of 5% (1% individually) with at least 99% statistical power, that 14 subjects were required to test for superiority for CLUE vision scores for Hyperopes.||59.4|45.2|
72608753|NCT05222880|144746037|SUPERIORITY|A superiority Margin of 41 CLUE Points was used for Myopes.|Mean Population Estimate|63.3|STANDARD_ERROR_OF_MEAN|2.054|||TWO_SIDED|99.0|58.0|68.6||||||It was calculated using a 2-sided one sample mean t-test with a family wise type I error rate of 5% (1% individually) with at least 99% statistical power, that 18 subjects were required to test for superiority for CLUE vision scores for Myopes.||68.6|58.0|
72608754|NCT05222880|144746038|SUPERIORITY|A superiority margin of 0.05 was used.|Mean Proportion|0.0019|STANDARD_DEVIATION|0.00209|||TWO_SIDED|95.0|0.0|0.0076|||Bayesian beta- binomial model|Bayesian beta-binomial model for correlated binary data||It was calculated using a Bayesian beta-binomial model for correlated data with a reference rate of 0.02 and an intraclass correlation of 0.70 with 2000 replicating trials, that 100 subjects were required to test for superiority to achieve a minimum statistical power of 90% with 95% central posterior credible.||0.0076|0.0000|
72608755|NCT05222880|144746039|SUPERIORITY|A superiority margin of 0.05 was used.|Mean Proportion|0.0018|STANDARD_DEVIATION|0.0021|||TWO_SIDED|95.0|0.0|0.0078|||Bayesian beta-binomial model|Bayesian beta-binomial model for correlated binary data||It was calculated using a Bayesian beta-binomial model for correlated data with a reference rate of 0.02 and an intraclass correlation of 0.70 with 2000 replicating trials, that 100 subjects were required to test for superiority to achieve a minimum statistical power of 90% with 95% central posterior credible.||0.0078|0.0000|
72608756|NCT05222880|144746040|SUPERIORITY|A superiority Margin of 41 CLUE Points was used for Hyperopes.|Mean Population Estimate|52.3|STANDARD_ERROR_OF_MEAN|2.75|||TWO_SIDED|99.0|45.2|59.4||||||It was calculated using a 2-sided one sample mean t-test with a family wise type I error rate of 5% (1% individually) with at least 80% statistical power, that 16 subjects were required to test for superiority for CLUE vision scores for Hyperopes.||59.4|45.2|
72608757|NCT05222880|144746040|SUPERIORITY|A superiority Margin of 46 CLUE Points was used for Myopes.|Mean Population Estimate|63.3|STANDARD_ERROR_OF_MEAN|2.054|||TWO_SIDED|99.0|58.0|68.6||||||It was calculated using a 2-sided one sample mean t-test with a family wise type I error rate of 5% (1% individually) with at least 80% statistical power, that 15 subjects were required to test for superiority for CLUE vision scores for Myopes.||68.6|58.0|
72608758|NCT05222880|144746041|SUPERIORITY|A Superiority margin of 52 CLUE points was used|Mean Population Estimate|72.6|STANDARD_ERROR_OF_MEAN|1.763|||TWO_SIDED|99.0|68.1|77.1||||||It was calculated using a 2-sided one sample mean t-test with a family wise type I error rate of 5% (1% individually) with at least 80% statistical power, that 11 subjects were required to test for superiority for CLUE comfort scores.||77.1|68.1|
72417375|NCT02130193|144345286|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.5|STANDARD_DEVIATION|0.87||0.42|TWO_SIDED|95.0|-2.11|1.14||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -1 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-breath, 8 month. Data presented are for 95% equal-tailed credible intervals|||1.14|-2.11|0.42
72608759|NCT05222880|144746042|SUPERIORITY|A Superiority margin of 53 CLUE points was used|Mean Population Estimate|67.6|STANDARD_ERROR_OF_MEAN|1.77|||TWO_SIDED|99.0|63.0|72.1||||||It was calculated using a 2-sided one sample mean t-test with a family wise type I error rate of 5% (1% individually) with at least 80% statistical power, that 17 subjects were required to test for superiority for CLUE handling scores.||72.1|63.0|
72608760|NCT05222880|144746043|SUPERIORITY|A superiority margin of 0.90 was used.|Mean Posterior Proportion|0.985|STANDARD_DEVIATION|0.0071|||TWO_SIDED|99.0|0.959|0.997|||Bayesian beta-binomial model|Bayesian beta-binomial model for correlated binary data||It was calculated using a Bayesian beta-binomial model for correlated data with a reference rate of 0.98 and an intraclass correlation of 0.70 with 2000 replicating trials, that 92 subjects were required to test for superiority to achieve a minimum statistical power of 80% with 99% central posterior credible.||0.997|0.959|
72608761|NCT02368132|144746050|SUPERIORITY||Least squares mean difference|-8.73|STANDARD_ERROR_OF_MEAN|2.57|<|0.001|TWO_SIDED||||||Mixed Models Analysis||Estimated difference in least square means between Usual Care (reference) and Group Delivered TEP arm at 3 months.|||||<0.001
72608762|NCT02368132|144746050|SUPERIORITY||Least squares mean difference|-5.15|STANDARD_ERROR_OF_MEAN|2.42||0.04|TWO_SIDED||||||Mixed Models Analysis||Estimated difference in least square means between Usual Care (reference) and Individual Delivered TEP arm at 3 months.|||||0.04
72608763|NCT02314728|144746053|SUPERIORITY|||||||0.99|||||||Fisher Exact|||||||0.99
72608764|NCT02314728|144746054|SUPERIORITY|||||||0.6|||||||Fisher Exact|||NICU admission||||0.60
72608765|NCT02314728|144746054|SUPERIORITY|||||||0.13|||||||Fisher Exact|||histologic chorioamnionitis||||0.13
72608766|NCT03118934|144746068|NON_INFERIORITY|The pre-specified non-inferiority margin is 0.5. With a sample size of 80/group, there was approximately 83% power to reject the null hypothesis of inferiority in fit with assumed standard deviation of 0.6 and expected difference of 0.25 (one-sided alpha=0.05).|LSM Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.06|||ONE_SIDED|95.0||-0.1||||||||-0.1||
72608767|NCT01614470|144746069|SUPERIORITY_OR_OTHER||Least squares (LS) mean difference|10.678|||<|0.0001|TWO_SIDED|95.0|7.2559|14.1|||Mixed Models Analysis|||||14.1000|7.2559|<0.0001
72608768|NCT01614470|144746070|SUPERIORITY_OR_OTHER||LS mean difference|0.6624|||<|0.0001|TWO_SIDED|95.0|0.3366|0.9881|||Mixed Models Analysis|||||0.9881|0.3366|<0.0001
72608769|NCT01614470|144746072|SUPERIORITY_OR_OTHER||LS mean difference|-49.1667|||<|0.0001|TWO_SIDED|95.0|-56.9527|-41.3807|||Mixed Models Analysis|||||-41.3807|-56.9527|<0.0001
72608770|NCT01614470|144746075|SUPERIORITY_OR_OTHER||LS mean difference|9.6105||||0.0004|TWO_SIDED|95.0|4.4874|14.7336|||Mixed Models Analysis|||||14.7336|4.4874|0.0004
72608771|NCT03217591|144746080|SUPERIORITY||Geometric mean change (%)|-16.0|||=|0.2142|TWO_SIDED|90.0|-33.3|5.8|||Mixed Models Analysis|||Treatment comparison between placebo and praliciguat 20 mg. Geometric mean change (%) and the associated confidence intervals (CIs) were derived as 100×\[exp(Least Squares Mean Change)-1\].||5.8|-33.3|=0.2142
72608772|NCT03217591|144746080|SUPERIORITY||Geometric mean change (%)|-14.6|||=|0.2718|TWO_SIDED|90.0|-32.7|8.3|||Mixed Models Analysis|||Treatment comparison between placebo and praliciguat 40 mg. Geometric mean change (%) and the associated CIs were derived as 100×\[exp(Least Squares Mean Change)-1\].||8.3|-32.7|=0.2718
72417376|NCT02130193|144345286|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.34|STANDARD_DEVIATION|0.88||0.35|TWO_SIDED|95.0|-2.14|1.23||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -0.7 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-breath, 9 month. Data presented are for 95% equal-tailed credible intervals|||1.23|-2.14|0.35
72608773|NCT03217591|144746080|SUPERIORITY||Geometric mean change (%)|-15.3|||=|0.1736|TWO_SIDED|90.0|-30.7|3.6|||Mixed Models Analysis|||Treatment comparison between placebo and praliciguat overall. Geometric mean change (%) and the associated CIs were derived as 100×\[exp(Least Squares Mean Change)-1\].||3.6|-30.7|=0.1736
72608774|NCT04232839|144746081|OTHER||Adjusted geometric mean (gMean) ratio(%)|85.9|||||TWO_SIDED|90.0|80.3|91.7|||||Test/reference, intra-individual geometric coefficient of variance (gCV) =13.9.|Analysis of variance (ANOVA) model on the logarithmic scale, including effects accounting for 'sequence', 'subjects nested within sequences', 'period', and 'treatment' (formulation). The effect 'subjects within sequences' was to be considered as random, while the other effects were to be considered as fixed.||91.7|80.3|
72608775|NCT04232839|144746081|OTHER||Adjusted geometric mean (gMean) ratio(%)|72.6|||||TWO_SIDED|90.0|68.0|77.6|||||Test/reference, intra-individual geometric coefficient of variance (gCV) =13.9.|Analysis of variance (ANOVA) model on the logarithmic scale, including effects accounting for 'sequence', 'subjects nested within sequences', 'period', and 'treatment' (formulation). The effect 'subjects within sequences' was to be considered as random, while the other effects were to be considered as fixed.||77.6|68.0|
72608776|NCT04232839|144746081|OTHER||Adjusted geometric mean (gMean) ratio(%)|92.4|||||TWO_SIDED|90.0|86.5|98.8|||||Test/reference, intra-individual geometric coefficient of variance (gCV) =13.9.|Analysis of variance (ANOVA) model on the logarithmic scale, including effects accounting for 'sequence', 'subjects nested within sequences', 'period', and 'treatment' (formulation). The effect 'subjects within sequences' was to be considered as random, while the other effects were to be considered as fixed.||98.8|86.5|
72608777|NCT04232839|144746081|OTHER||Adjusted geometric mean (gMean) ratio(%)|76.6|||||TWO_SIDED|90.0|71.6|81.8|||||Test/reference, intra-individual geometric coefficient of variance (gCV) =13.9.|Analysis of variance (ANOVA) model on the logarithmic scale, including effects accounting for 'sequence', 'subjects nested within sequences', 'period', and 'treatment' (formulation). The effect 'subjects within sequences' was to be considered as random, while the other effects were to be considered as fixed.||81.8|71.6|
72608778|NCT04232839|144746081|OTHER||Adjusted geometric mean (gMean) ratio(%)|133.4|||||TWO_SIDED|90.0|117.2|151.9|||||Test/reference, intra-individual geometric coefficient of variance (gCV) =17.6.|Analysis of variance (ANOVA) model on the logarithmic scale, including effects accounting for 'subjects' and 'treatment'. The effect 'subjects' were to be considered as random, while the effect 'treatment' was to be considered as fixed.||151.9|117.2|
72608779|NCT04232839|144746081|OTHER||Adjusted geometric mean (gMean) ratio(%)|114.2|||||TWO_SIDED|90.0|102.3|127.6|||||Test/reference, intra-individual geometric coefficient of variance (gCV) =16.2.|Analysis of variance (ANOVA) model on the logarithmic scale, including effects accounting for 'subjects' and 'treatment'. The effect 'subjects' were to be considered as random, while the effect 'treatment' was to be considered as fixed.||127.6|102.3|
72608780|NCT04232839|144746082|OTHER||Adjusted geometric mean (gMean) ratio(%)|85.5|||||TWO_SIDED|90.0|80.0|91.4|||||Test/reference, intra-individual geometric coefficient of variance (gCV) =14.0.|Analysis of variance (ANOVA) model on the logarithmic scale, including effects accounting for 'sequence', 'subjects nested within sequences', 'period', and 'treatment' (formulation). The effect 'subjects within sequences' was to be considered as random, while the other effects were to be considered as fixed.||91.4|80.0|
72608781|NCT04232839|144746082|OTHER||Adjusted geometric mean (gMean) ratio(%)|72.1|||||TWO_SIDED|90.0|67.4|77.1|||||Test/reference, intra-individual geometric coefficient of variance (gCV) =14.0.|Analysis of variance (ANOVA) model on the logarithmic scale, including effects accounting for 'sequence', 'subjects nested within sequences', 'period', and 'treatment' (formulation). The effect 'subjects within sequences' was to be considered as random, while the other effects were to be considered as fixed.||77.1|67.4|
72608782|NCT04232839|144746082|OTHER||Adjusted geometric mean (gMean) ratio(%)|92.2|||||TWO_SIDED|90.0|86.3|98.6|||||Test/reference, intra-individual geometric coefficient of variance (gCV) =14.0.|Analysis of variance (ANOVA) model on the logarithmic scale, including effects accounting for 'sequence', 'subjects nested within sequences', 'period', and 'treatment' (formulation). The effect 'subjects within sequences' was to be considered as random, while the other effects were to be considered as fixed.||98.6|86.3|
72417377|NCT02130193|144345286|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.89|STANDARD_DEVIATION|0.89||0.58|TWO_SIDED|95.0|-2.71|0.69||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -0.7 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-breath, 10 month. Data presented are for 95% equal-tailed credible intervals|||0.69|-2.71|0.58
72417378|NCT02130193|144345286|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.36|STANDARD_DEVIATION|0.91||0.36|TWO_SIDED|95.0|-2.15|1.41||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -0.7 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-breath, 11 month. Data presented are for 95% equal-tailed credible intervals|||1.41|-2.15|0.36
72608783|NCT04232839|144746082|OTHER||Adjusted geometric mean (gMean) ratio(%)|75.5|||||TWO_SIDED|90.0|70.6|80.7|||||Test/reference, intra-individual geometric coefficient of variance (gCV) =14.0.|Analysis of variance (ANOVA) model on the logarithmic scale, including effects accounting for 'sequence', 'subjects nested within sequences', 'period', and 'treatment' (formulation). The effect 'subjects within sequences' was to be considered as random, while the other effects were to be considered as fixed.||80.7|70.6|
72608784|NCT04232839|144746082|OTHER||Adjusted geometric mean (gMean) ratio(%)|134.2|||||TWO_SIDED|90.0|117.6|153.0|||||Test/reference, intra-individual geometric coefficient of variance (gCV) =17.9.|Analysis of variance (ANOVA) model on the logarithmic scale, including effects accounting for 'subjects' and 'treatment'. The effect 'subjects' were to be considered as random, while the effect 'treatment' was to be considered as fixed.||153.0|117.6|
72608785|NCT04232839|144746082|OTHER||Adjusted geometric mean (gMean) ratio(%)|114.8|||||TWO_SIDED|90.0|102.9|128.1|||||Test/reference, intra-individual geometric coefficient of variance (gCV) =16.1.|Analysis of variance (ANOVA) model on the logarithmic scale, including effects accounting for 'subjects' and 'treatment'. The effect 'subjects' were to be considered as random, while the effect 'treatment' was to be considered as fixed.||128.1|102.9|
72608786|NCT01419314|144746201|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|45.19|STANDARD_DEVIATION|20.25||0.001|TWO_SIDED|95.0|38.33|52.05|||ANOVA|Sphericity was not tenable for the factor pain scores, degrees of freedom were corrected using Huynh-Feldt estimates, df (1.71,56.46).||A repeated measure ANOVA was performed to evaluate the contrasts of interest.||52.05|38.33|0.001
72608787|NCT01419314|144746201|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.09|STANDARD_ERROR_OF_MEAN|3.6|<|0.0005|TWO_SIDED|95.0|8.8|23.39||Bonferroni adjustment for significance\<0.013.|t-test, 2 sided||Paired t-test contrasting pain scores from baseline to week six of the trial-Splint group. The statistical power for the within splint intervention contrast was calculated to be 0.99.|Null hypothesis: Is there a difference in baseline pain scores compared to those at week 6 in the splinting group?||23.39|8.80|<0.0005
72608788|NCT01419314|144746201|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.23|STANDARD_ERROR_OF_MEAN|5.27||0.155|TWO_SIDED|95.0|-13.93|7.47||Bonferroni adjustment for significance\<0.013.|t-test, 2 sided|df(35)|The statistical power for the between intervention contrast was calculated to be 0.26|Null Hypothesis: There is not difference in pain scores between the liner and splint applications at week three.||7.47|-13.93|0.155
72608789|NCT01419314|144746201|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.67|STANDARD_ERROR_OF_MEAN|6.66||0.155|TWO_SIDED|95.0|-23.2|3.85|||t-test, 2 sided|df(35)||Null Hypothesis: There is no difference in pain scores between the liner and splint applications at week six.||3.85|-23.20|0.155
72608790|NCT02084511|144746210|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|27.39|||||TWO_SIDED|95.0|-76.3|131.1|||||Mean difference (final values) is actually the Least square mean|ANCOVA model was used with 'treatment' as fixed effect, 'patient baseline pain intensity (BPI)' as continuous covariate and the residual error term.||131.1|-76.3|
72417379|NCT02130193|144345286|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.49|STANDARD_DEVIATION|0.9||0.41|TWO_SIDED|95.0|-2.36|1.13||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -0.7 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-breath, 12 month. Data presented are for 95% equal-tailed credible intervals|||1.13|-2.36|0.41
72417380|NCT02130193|144345286|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.14|STANDARD_DEVIATION|0.35||0.66|TWO_SIDED|95.0|-0.84|0.52||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-chest, 1 month. Data presented are for 95% equal-tailed credible intervals|||0.52|-0.84|0.66
72608791|NCT02084511|144746210|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|53.48|||||TWO_SIDED|95.0|-50.2|157.1|||||Mean difference (final values) is actually the Least square mean|ANCOVA model was used with 'treatment' as fixed effect, 'patient baseline pain intensity (BPI)' as continuous covariate and the residual error term.||157.1|-50.2|
72608792|NCT02084511|144746210|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-174.61|||||TWO_SIDED|95.0|-278.3|-70.9|||||Mean difference (final values) is actually the Least square mean|ANCOVA model was used with 'treatment' as fixed effect, 'patient baseline pain intensity (BPI)' as continuous covariate and the residual error term.||-70.9|-278.3|
72608793|NCT02084511|144746210|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-148.53|||||TWO_SIDED|95.0|-252.4|-44.7|||||Mean difference (final values) is actually the Least square mean|ANCOVA model was used with 'treatment' as fixed effect, 'patient baseline pain intensity (BPI)' as continuous covariate and the residual error term.||-44.7|-252.4|
72608794|NCT02084511|144746211|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.7|||||TWO_SIDED|95.0|-2.3|5.7|||||Mean difference (final values) is actually the Least square mean|ANCOVA model was used with 'treatment' as fixed effect, 'patient baseline pain intensity (BPI)' as continuous covariate and the residual error term.||5.7|-2.3|
72608795|NCT02084511|144746211|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.98|||||TWO_SIDED|95.0|-3.0|5.0|||||Mean difference (final values) is actually the Least square mean|ANCOVA model was used with 'treatment' as fixed effect, 'patient baseline pain intensity (BPI)' as continuous covariate and the residual error term.||5.0|-3.0|
72608796|NCT02084511|144746211|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.27|||||TWO_SIDED|95.0|-10.3|-2.2|||||Mean difference (final values) is actually the Least square mean|ANCOVA model was used with 'treatment' as fixed effect, 'patient baseline pain intensity (BPI)' as continuous covariate and the residual error term.||-2.2|-10.3|
72608797|NCT02084511|144746211|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.98|||||TWO_SIDED|95.0|-11.0|-2.9|||||Mean difference (final values) is actually the Least square mean|ANCOVA model was used with 'treatment' as fixed effect, 'patient baseline pain intensity (BPI)' as continuous covariate and the residual error term.||-2.9|-11.0|
72608798|NCT02084511|144746212|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.93|||||TWO_SIDED|95.0|-16.0|27.8|||||Mean difference (final values) is actually the Least square mean|ANCOVA model was used with 'treatment' as fixed effect, 'patient baseline pain intensity (BPI)' as continuous covariate and the residual error term.||27.8|-16.0|
72608799|NCT02084511|144746212|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|20.58|||||TWO_SIDED|95.0|-1.3|42.5|||||Mean difference (final values) is actually the Least square mean|ANCOVA model was used with 'treatment' as fixed effect, 'patient baseline pain intensity (BPI)' as continuous covariate and the residual error term.||42.5|-1.3|
72608800|NCT02084511|144746212|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.29|||||TWO_SIDED|95.0|-35.2|8.6|||||Mean difference (final values) is actually the Least square mean|ANCOVA model was used with 'treatment' as fixed effect, 'patient baseline pain intensity (BPI)' as continuous covariate and the residual error term.||8.6|-35.2|
72608801|NCT02084511|144746212|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.37|||||TWO_SIDED|95.0|-20.6|23.3|||||Mean difference (final values) is actually the Least square mean|ANCOVA model was used with 'treatment' as fixed effect, 'patient baseline pain intensity (BPI)' as continuous covariate and the residual error term.||23.3|-20.6|
72608802|NCT02084511|144746213|SUPERIORITY_OR_OTHER|||||||0.2503|||||||Log Rank|||Log rank test used to evaluate the difference between each active treatment and placebo.||||0.2503
72608803|NCT02084511|144746213|SUPERIORITY_OR_OTHER|||||||0.1851|||||||Log Rank|||Log rank test used to evaluate the difference between each active treatment and placebo.||||0.1851
72608804|NCT02084511|144746213|SUPERIORITY_OR_OTHER|||||||0.0167|||||||Log Rank|||Log rank test used to evaluate the difference between each active treatment and placebo.||||0.0167
72608805|NCT02084511|144746214|SUPERIORITY_OR_OTHER|||||||0.415|||||||Log Rank|||Log rank test used to evaluate the difference between each active treatment and placebo.||||0.4150
72608806|NCT02084511|144746214|SUPERIORITY_OR_OTHER|||||||0.3093|||||||Log Rank|||Log rank test used to evaluate the difference between each active treatment and placebo.||||0.3093
72608807|NCT02084511|144746214|SUPERIORITY_OR_OTHER|||||||0.0074|||||||Log Rank|||Log rank test used to evaluate the difference between each active treatment and placebo.||||0.0074
72608808|NCT01328964|144746216|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.71|||<|0.0001|TWO_SIDED|95.0|0.51|0.974||The p-value is a comparison of the combined hospitalization/emergency department visit endpoint|Regression, Cox|||||0.974|0.51|<0.0001
72608809|NCT01328964|144746217|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-14.0|||<|0.001|TWO_SIDED|95.0|-19.0|-9.0||P-value is based on the differences in the total monthly asthma costs|Regression, Linear|||||-9|-19|<0.001
72608810|NCT01328964|144746218|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.751||||0.0495|TWO_SIDED|95.0|0.565|0.999||P-value is based on the comparison of combined endpoint of hospitalization/emergency department visits|Regression, Cox|||||0.999|0.565|0.0495
72608811|NCT01328964|144746219|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-28.0|||<|0.0001|TWO_SIDED|95.0|-28.0|-27.0||P-value is based on difference in total monthly asthma costs|Regression, Linear|||||-27|-28|<0.0001
72608812|NCT03044314|144746273|SUPERIORITY|||||||0.148|||||||t-test, 2 sided|||Null hypothesis: inhalation with iNO (the gold standard) would provide greater response than the comparator (iloprost).||||0.148
72608813|NCT03044314|144746275|SUPERIORITY|||||||0.346|||||||Fisher Exact|||Null hypothesis was that fewer patients receiving iloprost (new agent) would respond compared to iNO (the gold standard).||||0.346
72608814|NCT02008526|144746309|SUPERIORITY||F|1.16||||0.3137|TWO_SIDED||||||ANOVA|2 Degrees of Freedom||||||0.3137
72608815|NCT02008526|144746310|SUPERIORITY||F|0.16||||0.8494|TWO_SIDED||||||ANOVA|2 Degrees of Freedom||||||0.8494
72608816|NCT00492726|144746322|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin was set to 10% in the protocol, in agreement with FDA recommendations. Sample size was estimated using the method as described in Farrington-Manning. Estimation was performed to achieve 85% power, based on the equivalence delta of 10%, and a clinical success rate of 80% in the per protocol population.|Difference of cure rates (in percent)|-3.8||||||95.0|-7.9|0.4|||||A positive value indicates an advantage for the treatment group of moxifloxacin, a negative value an advantage for the comparator group.|Calculated were 95% confidence intervals for the difference in success rates between treatment groups (moxifloxacin minus comparator).||0.4|-7.9|
72608817|NCT00492726|144746323|NON_INFERIORITY_OR_EQUIVALENCE|Sample size estimation was based on the primary efficacy variable.|Difference in improvement rates (in %)|1.1||||||95.0|-0.4|2.7|||||A positive value indicates an advantage for the treatment group of moxifloxacin, a negative value an advantage for the comparator group.|Calculated were 95% confidence intervals for the difference in success rates between treatment groups (moxifloxacin minus comparator).||2.7|-0.4|
72608818|NCT00492726|144746324|NON_INFERIORITY_OR_EQUIVALENCE|Sample size estimation was based on the primary efficacy variable.|Difference in bact. success rates (in %)|-3.9||||||95.0|-8.8|1.0|||||A positive value indicates an advantage for the treatment group of moxifloxacin, a negative value an advantage for the comparator group. Presumed eradications and eradications without superinfection were considered bacteriological successes.|Calculated were 95% confidence intervals for the difference in success rates between treatment groups (moxifloxacin minus comparator).||1.0|-8.8|
72608819|NCT00492726|144746325|NON_INFERIORITY_OR_EQUIVALENCE|Sample size estimation was based on the primary efficacy variable.|Difference of cure rates (in percent)|-1.5||||||95.0|-5.0|1.9|||||A positive value indicates an advantage for the treatment group of moxifloxacin, a negative value an advantage for the comparator group.|Calculated were 95% confidence intervals for the difference in success rates between treatment groups (moxifloxacin minus comparator).||1.9|-5.0|
72608820|NCT00492726|144746326|NON_INFERIORITY_OR_EQUIVALENCE|Sample size estimation was based on the primary efficacy variable.|Difference in bact. success rates (in %)|-3.9||||||95.0|-8.8|1.0|||||A positive value indicates an advantage for the treatment group of moxifloxacin, a negative value an advantage for the comparator group. Presumed eradications and eradications without superinfection were considered bacteriological successes.|Calculated were 95% confidence intervals for the difference in success rates between treatment groups (moxifloxacin minus comparator).||1.0|-8.8|
72608821|NCT00492726|144746327|NON_INFERIORITY_OR_EQUIVALENCE|Sample size estimation was based on the primary efficacy variable.|Difference in bact. success rates (in %)|-3.8||||||95.0|-9.0|1.5|||||A positive value indicates an advantage for the treatment group of moxifloxacin, a negative value an advantage for the comparator group. Presumed eradications and eradications without super- or reinfection were considered bacteriological successes.|Calculated were 95% confidence intervals for the difference in success rates between treatment groups (moxifloxacin minus comparator).||1.5|-9.0|
72608822|NCT00492726|144746328|NON_INFERIORITY_OR_EQUIVALENCE|Sample size estimation was based on the primary efficacy variable.|Difference of cure rates (in percent)|-2.9||||||95.0|-7.6|1.9|||||A positive value indicates an advantage for the treatment group of moxifloxacin, a negative value an advantage for the comparator group.|Calculated were 95% confidence intervals for the difference in success rates between treatment groups (moxifloxacin minus comparator).||1.9|-7.6|
72608823|NCT00828711|144746336|SUPERIORITY_OR_OTHER||Difference in Proportions|12.2||||0.057|TWO_SIDED|95.0|||||Cochran-Mantel-Haenszel|Adjusted for site effect|MVI 200 - MVI 100|The primary objective of this study is to compare the efficacy of MVI 100 and MVI 200 based on the proportion of vaginal deliveries within 24 hours. A minimum sample size of approximately 120 subjects per arm would provide 84 subjects per arm with vaginal delivery, which would ensure \>80% power (with two-sided alpha of 5%) to detect a 20% improvement in the proportion of women delivering vaginally within 24 hours||||0.057
72608824|NCT00828711|144746337|SUPERIORITY_OR_OTHER||Median Difference (Net)|-563.0||||0.018|TWO_SIDED|95.0|||||Log Rank||MVI 200 - MVI 100|Subjects who underwent a cesarean delivery during the first hospitalization were censored using the longest time interval from study drug administration to cesarean delivery during the first hospitalization, independent of treatment group. Subjects who, in their first hospitalization, were discharged prior to delivery or withdrew consent prior to delivery were censored using the longest time interval from study drug administration to labor and delivery discharge, independent of treatment group.||||0.018
72608825|NCT00828711|144746339|SUPERIORITY_OR_OTHER||Difference in Proportions|-8.46||||0.153|TWO_SIDED|95.0|||||Fisher Exact||MVI 200 - MVI 100|||||0.153
72608826|NCT00828711|144746340|SUPERIORITY_OR_OTHER||Difference in Proportions|2.37||||0.65|TWO_SIDED|95.0|||||Cochran-Mantel-Haenszel|Adjusted for site effect|MVI 200 - MVI 100|||||0.65
72608827|NCT00828711|144746341|SUPERIORITY_OR_OTHER||Difference in Proportions|-22.09|||<|0.001|TWO_SIDED|95.0|||||Cochran-Mantel-Haenszel|Adjusted for site effect|MVI 200 - MVI 100|||||<.001
72608828|NCT00828711|144746343|SUPERIORITY_OR_OTHER||Median Difference (Net)|-368.0||||0.007|TWO_SIDED|95.0|||||Log Rank||MVI 200 - MVI 100|Subjects who never went into active labor during the first hospitalization were censored using the longest time interval from study drug administration to delivery during the first hospitalization, independent of treatment group. Subjects who, in their first hospitalization, were discharged prior to delivery or withdraw consent prior to delivery will be censored using the longest time interval from study drug administration to labor and delivery discharge, independent of treatment group.||||0.007
72608829|NCT02100124|144746356|SUPERIORITY||Odds Ratio (OR)|0.87||||1|TWO_SIDED|95.0|0.56|1.36|||Regression, Logistic|||||1.36|0.56|1.0
72608830|NCT02100124|144746356|SUPERIORITY||Odds Ratio (OR)|1.13||||1|TWO_SIDED|95.0|0.7|1.83|||Regression, Logistic|||||1.83|0.70|1.0
72608831|NCT02100124|144746356|SUPERIORITY||Odds Ratio (OR)|1.3||||0.53|TWO_SIDED|95.0|0.82|2.08|||Regression, Logistic|||||2.08|0.82|0.53
72417381|NCT02130193|144345286|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.17|STANDARD_DEVIATION|0.39||0.66|TWO_SIDED|95.0|-0.94|0.55||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-chest, 2 month. Data presented are for 95% equal-tailed credible intervals|||0.55|-0.94|0.66
72417382|NCT02130193|144345286|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.56|STANDARD_DEVIATION|0.43||0.91|TWO_SIDED|95.0|-1.46|0.2||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-chest, 3 month. Data presented are for 95% equal-tailed credible intervals|||0.20|-1.46|0.91
72417383|NCT02130193|144345286|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.32|STANDARD_DEVIATION|0.41||0.79|TWO_SIDED|95.0|-1.16|0.44||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-chest, 4 month. Data presented are for 95% equal-tailed credible intervals|||0.44|-1.16|0.79
72417384|NCT02130193|144345286|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.4|STANDARD_DEVIATION|0.42||0.84|TWO_SIDED|95.0|-1.24|0.41||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-chest, 5 month. Data presented are for 95% equal-tailed credible intervals|||0.41|-1.24|0.84
72417385|NCT02130193|144345286|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.39|STANDARD_DEVIATION|0.44||0.81|TWO_SIDED|95.0|-1.23|0.47||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-chest, 6 month. Data presented are for 95% equal-tailed credible intervals|||0.47|-1.23|0.81
72417386|NCT02130193|144345286|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.32|STANDARD_DEVIATION|0.44||0.76|TWO_SIDED|95.0|-1.14|0.56||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-chest, 7 month. Data presented are for 95% equal-tailed credible intervals|||0.56|-1.14|0.76
72417387|NCT02130193|144345286|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.48|STANDARD_DEVIATION|0.48||0.84|TWO_SIDED|95.0|-1.43|0.43||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-chest, 8 month. Data presented are for 95% equal-tailed credible intervals|||0.43|-1.43|0.84
72417388|NCT02130193|144345286|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.46|STANDARD_DEVIATION|0.49||0.83|TWO_SIDED|95.0|-1.49|0.38||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-chest, 9 month. Data presented are for 95% equal-tailed credible intervals|||0.38|-1.49|0.83
72417389|NCT02130193|144345286|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.73|STANDARD_DEVIATION|0.49||0.94|TWO_SIDED|95.0|-1.68|0.2||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-chest, 10 month. Data presented are for 95% equal-tailed credible intervals|||0.20|-1.68|0.94
72417390|NCT02130193|144345286|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.49|STANDARD_DEVIATION|0.5||0.84|TWO_SIDED|95.0|-1.45|0.48||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-chest, 11 month. Data presented are for 95% equal-tailed credible intervals|||0.48|-1.45|0.84
72608832|NCT02100124|144746357|SUPERIORITY||Odds Ratio (OR)|0.88||||0.48|TWO_SIDED|95.0|0.71|1.09|||Regression, Logistic|||||1.09|0.71|0.48
72417391|NCT02130193|144345286|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.43|STANDARD_DEVIATION|0.5||0.81|TWO_SIDED|95.0|-1.36|0.55||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-chest, 12 month. Data presented are for 95% equal-tailed credible intervals|||0.55|-1.36|0.81
72417392|NCT02130193|144345286|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.14|STANDARD_DEVIATION|0.35||0.01|TWO_SIDED|95.0|-0.84|0.52||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -1 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-chest, 1 month. Data presented are for 95% equal-tailed credible intervals|||0.52|-0.84|0.01
72417393|NCT02130193|144345286|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.17|STANDARD_DEVIATION|0.39||0.02|TWO_SIDED|95.0|-0.94|0.55||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -1 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-chest, 2 month. Data presented are for 95% equal-tailed credible intervals|||0.55|-0.94|0.02
72608833|NCT02100124|144746357|SUPERIORITY||Odds Ratio (OR)|1.08||||1|TWO_SIDED|95.0|0.87|1.35|||Regression, Logistic|||||1.35|0.87|1.0
72608834|NCT02100124|144746357|SUPERIORITY||Odds Ratio (OR)|1.23||||0.07|TWO_SIDED|95.0|0.99|1.53|||Regression, Logistic|||||1.53|0.99|0.07
72417394|NCT02130193|144345286|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.56|STANDARD_DEVIATION|0.43||0.15|TWO_SIDED|95.0|-1.46|0.2||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -1 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-chest, 3 month. Data presented are for 95% equal-tailed credible intervals|||0.20|-1.46|0.15
72608835|NCT02100124|144746358|SUPERIORITY||Odds Ratio (OR)|1.04||||1|TWO_SIDED|95.0|0.84|1.29|||Regression, Logistic|||||1.29|0.84|1.0
72608836|NCT02100124|144746358|SUPERIORITY||Odds Ratio (OR)|1.02||||1|TWO_SIDED|95.0|0.82|1.26|||Regression, Logistic|||||1.26|0.82|1.0
72608837|NCT02100124|144746358|SUPERIORITY||Odds Ratio (OR)|0.98||||1|TWO_SIDED|95.0|0.79|1.22|||Regression, Logistic|||||1.22|0.79|1.0
72608838|NCT02100124|144746359|SUPERIORITY||Odds Ratio (OR)|1.07||||1|TWO_SIDED|95.0|0.83|1.37|||Regression, Logistic|||||1.37|0.83|1.0
72608839|NCT02100124|144746359|SUPERIORITY||Odds Ratio (OR)|1.04||||1|TWO_SIDED|95.0|0.81|1.33|||Regression, Logistic|||||1.33|0.81|1.0
72608840|NCT02100124|144746359|SUPERIORITY||Odds Ratio (OR)|0.97||||1|TWO_SIDED|95.0|0.75|1.25|||Regression, Logistic|||||1.25|0.75|1.0
72417395|NCT02130193|144345286|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.32|STANDARD_DEVIATION|0.41||0.05|TWO_SIDED|95.0|-1.16|0.44||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -1 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-chest, 4 month. Data presented are for 95% equal-tailed credible intervals|||0.44|-1.16|0.05
72417396|NCT02130193|144345286|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.4|STANDARD_DEVIATION|0.42||0.08|TWO_SIDED|95.0|-1.24|0.41||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -1 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-chest, 5 month. Data presented are for 95% equal-tailed credible intervals|||0.41|-1.24|0.08
72608841|NCT01181167|144746373|NON_INFERIORITY_OR_EQUIVALENCE|"Difference in incidence of thromboembolic events between DU-176b and enoxaparin groups and 95% confidence interval (CI) were calculated.~Incidence of thromboembolic events and 95% CI also calculated by treatment group.~Only when null hypothesis H01 was rejected, upper limit of 95% CI for difference between DU-176b and enoxaparin groups was confirmed. When upper limit of 95% CI was below 0%, DU-176b was considered to be superior to enoxaparin in terms of the prevention of VTE."|Cox Proportional Hazard|-4.5|||<|0.001|ONE_SIDED|95.0||||Farrington Manning Method|ANCOVA|||Hypothesis testing of proportion of subjects who experienced at least one thromboembolic events, defined as primary endpoint, carried out using Farrington-Manning method. Null hypothesis H˅01: Incidence of thromboembolic events in DU-176b group (P˅DU) = Incidence of thromboembolic events in enoxaparin group (P˅E) + Δ (8%). Alternative hypothesis H˅11: P˅DU \< P˅E + Δ (significance level: One-sided, 0.025)||||<0.001
72608842|NCT00408499|144746400|OTHER|Maximum tolerated dose was derived from toxicity data obtained from dose level 1-4.|Maximum tolerated dose|4.0|||||TWO_SIDED||||||||Maximum tolerated dose was determined to be dose level 4: 150 mg Erlotinib, 250 mg/m2 Cetuximab|||||
72608843|NCT02683109|144746421|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority of the Tio+Olo FDC versus the Tio/Olo free combination was tested at the one-sided α-level of 0.025 using a non-inferiority margin of 0.1 L.|Adjusted mean|0.024|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001|TWO_SIDED|95.0|-0.02|0.067|||ANCOVA|||The primary analysis was conducted using an Analysis of Covariance \[ANCOVA\] model including treatment as fixed categorical effect and baseline as continuous covariate.||0.067|-0.020|<0.0001
72608844|NCT02683109|144746422|SUPERIORITY_OR_OTHER||Adjusted mean|0.006|STANDARD_ERROR_OF_MEAN|0.034||0.8648|TWO_SIDED|95.0|-0.061|0.073|||ANCOVA|||The secondary analysis was conducted using an ANCOVA model including treatment as fixed categorical effect and baseline as continuous covariate.||0.073|-0.061|0.8648
72608845|NCT02683109|144746423|SUPERIORITY_OR_OTHER||Adjusted mean|-0.327|STANDARD_ERROR_OF_MEAN|0.536||0.542|TWO_SIDED|95.0|-1.384|0.729|||ANCOVA|||The secondary analysis was conducted using an ANCOVA model including treatment as fixed categorical effect and baseline as continuous covariate.||0.729|-1.384|0.5420
72608846|NCT03845894|144746428|NON_INFERIORITY|There have been no studies to evaluate pain scores ISB w/ plain bupi+adjuvants. Power to detect difference at least 0.4 on the VAS scale. Threshold for inferiority is difference \>=2 points on the VAS scale. Will use two-sample t test with α= 0.05 and β= 0.1. Postop opioid consumption, total post-op opioid @ 1st 48 hours in oxycodone equivalents. Mean opioid consumption per cohort is calculated, \& the cohorts compared for statistical difference with two-sample t test, with α= 0.05 and β= 0.1.||||||0.14|||||||Wilcoxon (Mann-Whitney)|||||||0.14
72608847|NCT02709746|144746452|SUPERIORITY||Mean Difference (Final Values)|1.13||||0.4702|TWO_SIDED|95.0|-1.94|4.2|||Mixed Model Repeated Analysis|||||4.2|-1.94|0.4702
72608848|NCT02709746|144746452|SUPERIORITY||Mean Difference (Final Values)|-0.72||||0.6373|TWO_SIDED|95.0|-3.71|2.27|||Mixed Model Repeated Analysis|||||2.27|-3.71|0.6373
72608849|NCT02709746|144746452|SUPERIORITY||Mean Difference (Final Values)|-3.73||||0.0152|TWO_SIDED|95.0|-6.74|-0.72|||Mixed Model Repeated Analysis|||||-0.72|-6.74|0.0152
72608850|NCT02709746|144746452|SUPERIORITY||Mean Difference (Final Values)|0.21||||0.8778|TWO_SIDED|95.0|-2.41|2.82|||Mixed Model Repeated Analysis|||||2.82|-2.41|0.8778
72608851|NCT02497469|144746514|SUPERIORITY||Adjusted Difference|8.8||||0.0061|TWO_SIDED|95.0|2.5|15.0|||Cochran-Mantel-Haenszel||||P-value of the adjusted difference was based on the Cochran-Mantel-Haenszel method, stratified by concomitant use of oral corticosteroids (Yes/No) and prior use of TNF-alpha antagonist (Yes/No) or the Fisher's exact method if the numerator was \<=5.|15.0|2.5|0.0061
72608852|NCT02497469|144746515|SUPERIORITY||Adjusted Difference|11.9||||0.0005|TWO_SIDED|95.0|5.3|18.5|||Cochran-Mantel-Haenszel||||P-value of the adjusted difference was based on the Cochran-Mantel-Haenszel method, stratified by concomitant use of oral corticosteroids (Yes/No) and prior use of TNF-alpha antagonist (Yes/No) or the Fisher's exact method if the numerator was \<=5.|18.5|5.3|0.0005
72417397|NCT02130193|144345286|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.39|STANDARD_DEVIATION|0.44||0.08|TWO_SIDED|95.0|-1.23|0.47||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -1 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-chest, 6 month. Data presented are for 95% equal-tailed credible intervals|||0.47|-1.23|0.08
72417398|NCT02130193|144345286|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.32|STANDARD_DEVIATION|0.44||0.06|TWO_SIDED|95.0|-1.14|0.56||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -1 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-chest, 7 month. Data presented are for 95% equal-tailed credible intervals|||0.56|-1.14|0.06
72608853|NCT02497469|144746516|SUPERIORITY||Adjusted Difference|-9.3||||0.0641|TWO_SIDED|95.0|-18.9|0.4|||Cochran-Mantel-Haenszel||||P-value of the adjusted difference was based on the Cochran-Mantel-Haenszel method, stratified by prior use of TNF-alpha antagonist (Yes/No) or the Fisher's exact method if the numerator was \<=5.|0.4|-18.9|0.0641
72417399|NCT02130193|144345286|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.48|STANDARD_DEVIATION|0.48||0.14|TWO_SIDED|95.0|-1.43|0.43||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -1 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-chest, 8 month. Data presented are for 95% equal-tailed credible intervals|||0.43|-1.43|0.14
72417400|NCT02130193|144345286|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.46|STANDARD_DEVIATION|0.49||0.14|TWO_SIDED|95.0|-1.49|0.38||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -1 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-chest, 9 month. Data presented are for 95% equal-tailed credible intervals|||0.38|-1.49|0.14
72417401|NCT02130193|144345286|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.73|STANDARD_DEVIATION|0.49||0.29|TWO_SIDED|95.0|-1.68|0.2||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -1 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-chest, 10 month. Data presented are for 95% equal-tailed credible intervals|||0.20|-1.68|0.29
72417402|NCT02130193|144345286|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.49|STANDARD_DEVIATION|0.5||0.15|TWO_SIDED|95.0|-1.45|0.48||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -1 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-chest, 11 month. Data presented are for 95% equal-tailed credible intervals|||0.48|-1.45|0.15
72417403|NCT02130193|144345286|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.43|STANDARD_DEVIATION|0.5||0.13|TWO_SIDED|95.0|-1.36|0.55||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -1 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-chest, 12 month. Data presented are for 95% equal-tailed credible intervals|||0.55|-1.36|0.13
72417404|NCT02130193|144345286|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.14|STANDARD_DEVIATION|0.35||0.06|TWO_SIDED|95.0|-0.84|0.52||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -0.7 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-chest, 1 month. Data presented are for 95% equal-tailed credible intervals|||0.52|-0.84|0.06
72608854|NCT00289211|144746518|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|2.048||||0.048||95.0|1.008|4.164|||Regression, Cox|||Subjects who did not experience beginning of substantial relief of the defining symptom within 4 hours after initial treatment were included in the analysis as censored observations. Entries of 4.0 (hours) for median time to event or 95% CI indicate that data were NE (see Population Description). As non-numeric data are not supported by the median and 95% CI fields, entry of the actual results (ie, NE or \>4.0) was not possible.||4.164|1.008|0.048
72608855|NCT00289211|144746519|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|1.41||||0.062||95.0|0.87|2.29|||Cochran-Mantel-Haenszel|||||2.29|0.87|0.062
72417405|NCT02130193|144345286|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.17|STANDARD_DEVIATION|0.39||0.09|TWO_SIDED|95.0|-0.94|0.55||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -0.7 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-chest, 2 month. Data presented are for 95% equal-tailed credible intervals|||0.55|-0.94|0.09
72417406|NCT02130193|144345286|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.56|STANDARD_DEVIATION|0.43||0.37|TWO_SIDED|95.0|-1.46|0.2||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -0.7 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-chest, 3 month. Data presented are for 95% equal-tailed credible intervals|||0.20|-1.46|0.37
72417407|NCT02130193|144345286|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.32|STANDARD_DEVIATION|0.41||0.18|TWO_SIDED|95.0|-1.16|0.44||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -0.7 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-chest, 4 month. Data presented are for 95% equal-tailed credible intervals|||0.44|-1.16|0.18
72417408|NCT02130193|144345286|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.4|STANDARD_DEVIATION|0.42||0.24|TWO_SIDED|95.0|-1.24|0.41||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -0.7 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-chest, 5 month. Data presented are for 95% equal-tailed credible intervals|||0.41|-1.24|0.24
72417409|NCT02130193|144345286|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.39|STANDARD_DEVIATION|0.44||0.24|TWO_SIDED|95.0|-1.23|0.47||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -0.7 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-chest, 6 month. Data presented are for 95% equal-tailed credible intervals|||0.47|-1.23|0.24
72417410|NCT02130193|144345286|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.32|STANDARD_DEVIATION|0.44||0.19|TWO_SIDED|95.0|-1.14|0.56||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -0.7 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-chest, 7 month. Data presented are for 95% equal-tailed credible intervals|||0.56|-1.14|0.19
72608856|NCT00289211|144746520|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|2.717||||0.001||95.0|1.471|5.02|||Regression, Cox|||Subjects who had not experienced complete resolution of the HAE attack at the time of the follow-up telephone call, or who were lost to follow-up, were censored at 72 hours.||5.020|1.471|0.001
72608857|NCT00289211|144746521|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0||||Change at 1 hour post-infusion.|Wilcoxon (Mann-Whitney)|||||||<0.0001
72608858|NCT00289211|144746521|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0||||Change at 2 hours post-infusion.|Wilcoxon (Mann-Whitney)|||||||<0.0001
72608859|NCT00289211|144746521|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0||||Change at 4 hours post-infusion.|Wilcoxon (Mann-Whitney)|||||||<0.0001
72608860|NCT00289211|144746521|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0007||95.0||||Change at 12 hours post-infusion.|Wilcoxon (Mann-Whitney)|||||||0.0007
72608861|NCT00289211|144746522|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0||||Percent change 1 hour post-infusion.|Wilcoxon (Mann-Whitney)|||||||<0.0001
72608862|NCT00289211|144746522|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0||||Percent change 2 hours post-infusion.|Wilcoxon (Mann-Whitney)|||||||<0.0001
72608863|NCT00289211|144746522|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0||||Percent change 4 hours post-infusion.|Wilcoxon (Mann-Whitney)|||||||<0.0001
72608864|NCT00289211|144746522|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0022||95.0||||Percent change 12 hours post-infusion.|Wilcoxon (Mann-Whitney)|||||||0.0022
72608865|NCT00289211|144746523|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1321||95.0||||Change at 1 hour post-infusion.|Wilcoxon (Mann-Whitney)|||||||0.1321
72417411|NCT02130193|144345286|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.48|STANDARD_DEVIATION|0.48||0.32|TWO_SIDED|95.0|-1.43|0.43||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -0.7 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-chest, 8 month. Data presented are for 95% equal-tailed credible intervals|||0.43|-1.43|0.32
72417412|NCT02130193|144345286|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.46|STANDARD_DEVIATION|0.49||0.32|TWO_SIDED|95.0|-1.49|0.38||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -0.7 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-chest, 9 month. Data presented are for 95% equal-tailed credible intervals|||0.38|-1.49|0.32
72417413|NCT02130193|144345286|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.73|STANDARD_DEVIATION|0.49||0.52|TWO_SIDED|95.0|-1.68|0.2||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -0.7 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-chest, 10 month. Data presented are for 95% equal-tailed credible intervals|||0.20|-1.68|0.52
72608866|NCT00289211|144746523|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5218||95.0||||Change at 2 hours post-infusion.|Wilcoxon (Mann-Whitney)|||||||0.5218
72417414|NCT02130193|144345286|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.49|STANDARD_DEVIATION|0.5||0.33|TWO_SIDED|95.0|-1.45|0.48||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -0.7 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-chest, 11 month. Data presented are for 95% equal-tailed credible intervals|||0.48|-1.45|0.33
72417415|NCT02130193|144345286|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.43|STANDARD_DEVIATION|0.5||0.29|TWO_SIDED|95.0|-1.36|0.55||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -0.7 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-chest, 12 month. Data presented are for 95% equal-tailed credible intervals|||0.55|-1.36|0.29
72417416|NCT02130193|144345286|SUPERIORITY_OR_OTHER||Posterior mean difference|0.06|STANDARD_DEVIATION|0.31||0.43|TWO_SIDED|95.0|-0.59|0.62||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-cough, 1 month. Data presented are for 95% equal-tailed credible intervals|||0.62|-0.59|0.43
72608867|NCT00289211|144746523|SUPERIORITY_OR_OTHER_LEGACY|||||||0.121||95.0||||Change at 4 hours post-infusion.|Wilcoxon (Mann-Whitney)|||||||0.1210
72608868|NCT00289211|144746523|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0017||95.0||||Change at 12 hours post-infusion.|Wilcoxon (Mann-Whitney)|||||||0.0017
72608869|NCT03863353|144746536|SUPERIORITY||Rebression coefficient|2.13||||0.001|TWO_SIDED|95.0|0.86|3.4||Adjusted for repeated measures and effects of covariates|Regression, Linear|||Hypothesis was tested using multivariable regression models (generalized estimating equation)||3.40|0.86|.001
72608870|NCT03863353|144746537|SUPERIORITY||Odds Ratio (OR)|1.17||||0.534|TWO_SIDED|95.0|0.72|1.9||adjusted for covariates|Regression, Logistic|||Logistic regression model examined the effect of the intervention on the outcome (collapsed intentions/behaviors)||1.90|0.72|0.534
72608871|NCT00323063|144746551|OTHER|||||||0.3|||||||Log Rank|||||||0.3
72608872|NCT00269152|144746610|SUPERIORITY_OR_OTHER||Feasibility Response Rate (percentage)|59.4|||||TWO_SIDED|95.0|46.4|71.5||||||||71.5|46.4|
72608873|NCT00269152|144746610|SUPERIORITY_OR_OTHER||Feasibility Response Rate (percentage)|50.0||||||95.0|36.1|63.9||||||||63.9|36.1|
72608874|NCT04249427|144746615|EQUIVALENCE|Test if the change in mean number of days with significant mid-facial pain in Erenuman group differs from that in Placebo group.||||||0.96|||||||ANOVA|||||||0.96
72608875|NCT04249427|144746616|EQUIVALENCE|Test if the change in SNOT-22 score in Erenuman group differs from that in Placebo group.||||||0.19|||||||ANOVA|||||||0.19
72608876|NCT04249427|144746617|EQUIVALENCE|Test if the change in Physical Function as Measured by Migraine Function Impact in Erenuman group differs from that in Placebo group.||||||0.06|||||||ANOVA|||||||0.06
72608877|NCT04249427|144746618|EQUIVALENCE|Test if the change in Usual Activities as Measured by Migraine Function Impact in Erenuman group differs from that in Placebo group.||||||0.08|||||||Wilcoxon (Mann-Whitney)|||||||0.08
72608878|NCT04249427|144746619|EQUIVALENCE|Test if the change in Social Function as Measured by Migraine Function Impact in Erenuman group differs from that in Placebo group.||||||0.058|||||||ANOVA|||||||0.058
72608879|NCT04249427|144746620|EQUIVALENCE|Test if the change in Emotional Function as Measured by Migraine Function Impact in Erenuman group differs from that in Placebo group.||||||0.02|||||||ANOVA|||||||0.02
72608880|NCT04249427|144746621|EQUIVALENCE|Test if the change in Overall Impact (global) as Measured by Migraine Function Impact in Erenuman group differs from that in Placebo group.||||||0.0036|||||||ANOVA|||||||0.0036
72608881|NCT04249427|144746622|EQUIVALENCE|Test if the change of average number of days per month with significant nasal congestion in Erenuman group differs from that in Placebo group.||||||0.83|||||||ANOVA|||||||0.83
72608882|NCT04249427|144746623|EQUIVALENCE|Test if the change of average number of days per month with significant significant rhinorrhea in Erenuman group differs from that in Placebo group||||||0.83|||||||ANOVA|||||||0.83
72608883|NCT04249427|144746624|EQUIVALENCE|Test if the change in doses of rescue pain medications in Erenuman group differs from that in Placebo group.||||||0.35|||||||Wilcoxon (Mann-Whitney)|||||||0.35
72608884|NCT04249427|144746625|EQUIVALENCE|Test if the change from baseline in mean daily pain score in Erenuman group differs from that in Placebo group.||||||0.85|||||||Wilcoxon (Mann-Whitney)|||||||0.85
72417417|NCT02130193|144345286|SUPERIORITY_OR_OTHER||Posterior mean difference|0.19|STANDARD_DEVIATION|0.35||0.29|TWO_SIDED|95.0|-0.53|0.85||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-cough, 2 month. Data presented are for 95% equal-tailed credible intervals|||0.85|-0.53|0.29
72417418|NCT02130193|144345286|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.2|STANDARD_DEVIATION|0.38||0.7|TWO_SIDED|95.0|-0.94|0.52||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-cough, 3 month. Data presented are for 95% equal-tailed credible intervals|||0.52|-0.94|0.70
72417419|NCT02130193|144345286|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.21|STANDARD_DEVIATION|0.37||0.71|TWO_SIDED|95.0|-0.92|0.5||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-cough, 4 month. Data presented are for 95% equal-tailed credible intervals|||0.50|-0.92|0.71
72417420|NCT02130193|144345286|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.11|STANDARD_DEVIATION|0.37||0.61|TWO_SIDED|95.0|-0.82|0.61||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-cough, 5 month. Data presented are for 95% equal-tailed credible intervals|||0.61|-0.82|0.61
72417421|NCT02130193|144345286|SUPERIORITY_OR_OTHER||Posterior mean difference|0.02|STANDARD_DEVIATION|0.36||0.48|TWO_SIDED|95.0|-0.69|0.69||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-cough, 6 month. Data presented are for 95% equal-tailed credible intervals|||0.69|-0.69|0.48
72417422|NCT02130193|144345286|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.08|STANDARD_DEVIATION|0.36||0.58|TWO_SIDED|95.0|-0.79|0.62||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-cough, 7 month. Data presented are for 95% equal-tailed credible intervals|||0.62|-0.79|0.58
72417423|NCT02130193|144345286|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.39|STANDARD_DEVIATION|0.4||0.83|TWO_SIDED|95.0|-1.12|0.43||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-cough, 8 month. Data presented are for 95% equal-tailed credible intervals|||0.43|-1.12|0.83
72417424|NCT02130193|144345286|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.26|STANDARD_DEVIATION|0.41||0.74|TWO_SIDED|95.0|-1.07|0.52||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-cough, 9 month. Data presented are for 95% equal-tailed credible intervals|||0.52|-1.07|0.74
72417425|NCT02130193|144345286|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.53|STANDARD_DEVIATION|0.43||0.89|TWO_SIDED|95.0|-1.4|0.29||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-cough, 10 month. Data presented are for 95% equal-tailed credible intervals|||0.29|-1.40|0.89
72417426|NCT02130193|144345286|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.1|STANDARD_DEVIATION|0.41||0.59|TWO_SIDED|95.0|-0.89|0.69||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-cough, 11 month. Data presented are for 95% equal-tailed credible intervals|||0.69|-0.89|0.59
72417427|NCT02130193|144345286|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.3|STANDARD_DEVIATION|0.42||0.77|TWO_SIDED|95.0|-1.12|0.54||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-cough, 12 month. Data presented are for 95% equal-tailed credible intervals|||0.54|-1.12|0.77
72417428|NCT02130193|144345286|SUPERIORITY_OR_OTHER||Posterior mean difference|0.06|STANDARD_DEVIATION|0.31||0.01|TWO_SIDED|95.0|-0.59|0.62||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -0.7 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-cough, 1 month. Data presented are for 95% equal-tailed credible intervals|||0.62|-0.59|0.01
72417429|NCT02130193|144345286|SUPERIORITY_OR_OTHER||Posterior mean difference|0.19|STANDARD_DEVIATION|0.35||0.01|TWO_SIDED|95.0|-0.53|0.85||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -0.7 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-cough, 2 month. Data presented are for 95% equal-tailed credible intervals|||0.85|-0.53|0.01
72417430|NCT02130193|144345286|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.2|STANDARD_DEVIATION|0.38||0.09|TWO_SIDED|95.0|-0.94|0.52||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -0.7 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-cough, 3 month. Data presented are for 95% equal-tailed credible intervals|||0.52|-0.94|0.09
72417431|NCT02130193|144345286|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.21|STANDARD_DEVIATION|0.37||0.09|TWO_SIDED|95.0|-0.92|0.5||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -0.7 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-cough, 4 month. Data presented are for 95% equal-tailed credible intervals|||0.50|-0.92|0.09
72417432|NCT02130193|144345286|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.11|STANDARD_DEVIATION|0.37||0.05|TWO_SIDED|95.0|-0.82|0.61||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -0.7 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-cough, 5 month. Data presented are for 95% equal-tailed credible intervals|||0.61|-0.82|0.05
72608885|NCT02557399|144746626|SUPERIORITY_OR_OTHER||difference in percent|-6.83||||0.008|TWO_SIDED|95.0|-11.88|-1.78||The analysis method was mixed model repeated measures analysis with treatment, center, visit, treatment-by-visit interaction, Baseline TLs counts, Baseline-by-visit interaction as fixed effects.|mixed model repeated measures analysis||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 2. A negative treatment difference indicates a benefit of Duac relative to ADA+CLDM.|||-1.78|-11.88|0.008
72608886|NCT02557399|144746627|SUPERIORITY_OR_OTHER||difference in percent|-0.25||||0.916|TWO_SIDED|95.0|-4.85|4.35||The analysis method was mixed-model for repeated measures with treatment, center, visit, treatment-by-visit interaction, Baseline TLs counts, Baseline-by-visit interaction as fixed effects.|mixed model repeated measures analysis||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 1|||4.35|-4.85|0.916
72608887|NCT02557399|144746627|SUPERIORITY_OR_OTHER||difference in percent|-5.85||||0.01|TWO_SIDED|95.0|-10.29|-1.42||The analysis method was mixed-model for repeated measures with treatment, center, visit, treatment-by-visit interaction, Baseline TLs counts, Baseline-by-visit interaction as fixed effects.|mixed model repeated measures analysis||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 4|||-1.42|-10.29|0.010
72608888|NCT02557399|144746627|SUPERIORITY_OR_OTHER||difference in percent|-2.35||||0.257|TWO_SIDED|95.0|-6.42|1.72||The analysis method was mixed-model for repeated measures with treatment, center, visit, treatment-by-visit interaction, Baseline TLs counts, Baseline-by-visit interaction as fixed effects.|mixed model repeated measures analysis||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 8|||1.72|-6.42|0.257
72608889|NCT02557399|144746627|SUPERIORITY_OR_OTHER||difference in percent|-3.24||||0.062|TWO_SIDED|95.0|-6.64|0.16||The analysis method was mixed-model for repeated measures with treatment, center, visit, treatment-by-visit interaction, Baseline TLs counts, Baseline-by-visit interaction as fixed effects.|mixed model repeated measures analysis||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 12|||0.16|-6.64|0.062
72608890|NCT02557399|144746628|SUPERIORITY_OR_OTHER||difference in percent|-5.08||||0.115|TWO_SIDED|95.0|-11.41|1.25||The analysis method was mixed-model for repeated measures with treatment, center, visit, treatment-by-visit interaction, Baseline ILs counts, Baseline-by-visit interaction as fixed effects.|mixed model repeated measures analysis||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 1 for ILs. A negative treatment difference indicates a benefit of Duac relative to ADA+CLDM.|||1.25|-11.41|0.115
72608891|NCT02557399|144746628|SUPERIORITY_OR_OTHER||difference in percent|-8.43||||0.005|TWO_SIDED|95.0|-14.35|-2.51||The analysis method was mixed-model for repeated measures with treatment, center, visit, treatment-by-visit interaction, Baseline ILs counts, Baseline-by-visit interaction as fixed effects.|mixed model repeated measures analysis||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 2 for ILs. A negative treatment difference indicates a benefit of Duac relative to ADA+CLDM.|||-2.51|-14.35|0.005
72608892|NCT02557399|144746628|SUPERIORITY_OR_OTHER||difference in percent|-9.37|||<|0.001|TWO_SIDED|95.0|-14.42|-4.33||The analysis method was mixed-model for repeated measures with treatment, center, visit, treatment-by-visit interaction, Baseline ILs counts, Baseline-by-visit interaction as fixed effects.|mixed model repeated measures analysis||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 4 for ILs. A negative treatment difference indicates a benefit of Duac relative to ADA+CLDM.|||-4.33|-14.42|<0.001
72608893|NCT02557399|144746628|SUPERIORITY_OR_OTHER||difference in percent|-6.69||||0.004|TWO_SIDED|95.0|-11.21|-2.16||The analysis method was mixed-model for repeated measures with treatment, center, visit, treatment-by-visit interaction, Baseline ILs counts, Baseline-by-visit interaction as fixed effects.|mixed model repeated measures analysis||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 8 for ILs. A negative treatment difference indicates a benefit of Duac relative to ADA+CLDM.|||-2.16|-11.21|0.004
72608894|NCT02557399|144746628|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.5||||0.015|TWO_SIDED|95.0|-8.1|-0.89||The analysis method was mixed-model for repeated measures with treatment, center, visit, treatment-by-visit interaction, Baseline ILs counts, Baseline-by-visit interaction as fixed effects.|mixed model repeated measures analysis||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 12 for ILs|||-0.89|-8.10|0.015
72608895|NCT02557399|144746628|SUPERIORITY_OR_OTHER||difference in percent|2.71||||0.382|TWO_SIDED|95.0|-3.38|8.8||The analysis method was mixed-model for repeated measures with treatment, center, visit, treatment-by-visit interaction, Baseline non-ILs counts, Baseline-by-visit interaction as fixed effects.|mixed model repeated measures analysis||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 1 for non-ILs. A negative treatment difference indicates a benefit of Duac relative to ADA+CLDM.|||8.80|-3.38|0.382
72608896|NCT02557399|144746628|SUPERIORITY_OR_OTHER||difference in percent|-5.69||||0.085|TWO_SIDED|95.0|-12.17|0.78||The analysis method was mixed-model for repeated measures with treatment, center, visit, treatment-by-visit interaction, Baseline non-ILs counts, Baseline-by-visit interaction as fixed effects.|mixed model repeated measures analysis||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 2 for non-ILs. A negative treatment difference indicates a benefit of Duac relative to ADA+CLDM.|||0.78|-12.17|0.085
72608897|NCT02557399|144746628|SUPERIORITY_OR_OTHER||difference in percent|-3.89||||0.186|TWO_SIDED|95.0|-9.67|1.88||The analysis method was mixed-model for repeated measures with treatment, center, visit, treatment-by-visit interaction, Baseline non-ILs counts, Baseline-by-visit interaction as fixed effects.|mixed model repeated measures analysis||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 4 for non-ILs. A negative treatment difference indicates a benefit of Duac relative to ADA+CLDM.|||1.88|-9.67|0.186
72608898|NCT02557399|144746628|SUPERIORITY_OR_OTHER||difference in percent|-0.59||||0.818|TWO_SIDED|95.0|-5.61|4.44||The analysis method was mixed-model for repeated measures with treatment, center, visit, treatment-by-visit interaction, Baseline non-ILs counts, Baseline-by-visit interaction as fixed effects.|mixed model repeated measures analysis||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 8 for non-ILs. A negative treatment difference indicates a benefit of Duac relative to ADA+CLDM.|||4.44|-5.61|0.818
72417433|NCT02130193|144345286|SUPERIORITY_OR_OTHER||Posterior mean difference|0.02|STANDARD_DEVIATION|0.36||0.02|TWO_SIDED|95.0|-0.69|0.69||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -0.7 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-cough, 6 month. Data presented are for 95% equal-tailed credible intervals|||0.69|-0.69|0.02
72417434|NCT02130193|144345286|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.08|STANDARD_DEVIATION|0.36||0.04|TWO_SIDED|95.0|-0.79|0.62||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -0.7 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-cough, 7 month. Data presented are for 95% equal-tailed credible intervals|||0.62|-0.79|0.04
72608899|NCT02557399|144746628|SUPERIORITY_OR_OTHER||difference in percent|-3.78||||0.073|TWO_SIDED|95.0|-7.92|0.35||The analysis method was mixed-model for repeated measures with treatment, center, visit, treatment-by-visit interaction, Baseline non-ILs counts, Baseline-by-visit interaction as fixed effects.|mixed model repeated measures analysis||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 12 for non-ILs. A negative treatment difference indicates a benefit of Duac relative to ADA+CLDM.|||0.35|-7.92|0.073
72608900|NCT02557399|144746629|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1||||0.961|TWO_SIDED|95.0|-4.6|4.4||The analysis method was mixed-model for repeated measures with treatment, center, visit, treatment-by-visit interaction, Baseline TLs counts, Baseline-by-visit interaction as fixed effects.|mixed model repeated measures analysis||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 1 for TLs. negative treatment difference indicates a benefit of Duac relative to ADA+CLDM.|||4.4|-4.6|0.961
72608901|NCT02557399|144746629|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-6.2||||0.015|TWO_SIDED|95.0|-11.2|-1.2||The analysis method was mixed-model for repeated measures with treatment, center, visit, treatment-by-visit interaction, Baseline TLs counts, Baseline-by-visit interaction as fixed effects.|mixed model repeated measures analysis||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 2 for TLs. negative treatment difference indicates a benefit of Duac relative to ADA+CLDM.|||-1.2|-11.2|0.015
72608902|NCT02557399|144746629|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.7||||0.044|TWO_SIDED|95.0|-9.2|-0.1||The analysis method was mixed-model for repeated measures with treatment, center, visit, treatment-by-visit interaction, Baseline TLs counts, Baseline-by-visit interaction as fixed effects.|mixed model repeated measures analysis||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 4 for TLs. A negative treatment difference indicates a benefit of Duac relative to ADA+CLDM.|||-0.1|-9.2|0.044
72608903|NCT02557399|144746629|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.7||||0.747|TWO_SIDED|95.0|-4.9|3.5||The analysis method was mixed-model for repeated measures with treatment, center, visit, treatment-by-visit interaction, Baseline TLs counts, Baseline-by-visit interaction as fixed effects.|mixed model repeated measures analysis||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 8 for TLs. A negative treatment difference indicates a benefit of Duac relative to ADA+CLDM.|||3.5|-4.9|0.747
72608904|NCT02557399|144746629|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.7||||0.338|TWO_SIDED|95.0|-5.3|1.8||The analysis method was mixed-model for repeated measures with treatment, center, visit, treatment-by-visit interaction, Baseline TLs counts, Baseline-by-visit interaction as fixed effects.|mixed model repeated measures analysis||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 12 for TLs. A negative treatment difference indicates a benefit of Duac relative to ADA+CLDM.|||1.8|-5.3|0.338
72608905|NCT02557399|144746629|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.8||||0.068|TWO_SIDED|95.0|-3.8|0.1||The analysis method was mixed-model for repeated measures with treatment, center, visit, treatment-by-visit interaction, Baseline ILs counts, Baseline-by-visit interaction as fixed effects.|mixed model repeated measures analysis||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 1 for ILs. A negative treatment difference indicates a benefit of Duac relative to ADA+CLDM.|||0.1|-3.8|0.068
72608906|NCT02557399|144746629|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.0||||0.002|TWO_SIDED|95.0|-4.8|-1.1||The analysis method was mixed-model for repeated measures with treatment, center, visit, treatment-by-visit interaction, Baseline ILs counts, Baseline-by-visit interaction as fixed effects.|mixed model repeated measures analysis||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 2 for ILs. A negative treatment difference indicates a benefit of Duac relative to ADA+CLDM.|||-1.1|-4.8|0.002
72608907|NCT02557399|144746629|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.6||||0.002|TWO_SIDED|95.0|-4.3|-1.0||The analysis method was mixed-model for repeated measures with treatment, center, visit, treatment-by-visit interaction, Baseline ILs counts, Baseline-by-visit interaction as fixed effects.|mixed model repeated measures analysis||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 4 for ILs. A negative treatment difference indicates a benefit of Duac relative to ADA+CLDM.|||-1.0|-4.3|0.002
72608908|NCT02557399|144746629|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.9||||0.012|TWO_SIDED|95.0|-3.4|-0.4||The analysis method was mixed-model for repeated measures with treatment, center, visit, treatment-by-visit interaction, Baseline ILs counts, Baseline-by-visit interaction as fixed effects.|mixed model repeated measures analysis||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 8 for ILs. A negative treatment difference indicates a benefit of Duac relative to ADA+CLDM.|||-0.4|-3.4|0.012
72608909|NCT02557399|144746629|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.1||||0.078|TWO_SIDED|95.0|-2.4|0.1||The analysis method was mixed-model for repeated measures with treatment, center, visit, treatment-by-visit interaction, Baseline ILs counts, Baseline-by-visit interaction as fixed effects.|mixed model repeated measures analysis||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 12 for ILs. A negative treatment difference indicates a benefit of Duac relative to ADA+CLDM.|||0.1|-2.4|0.078
72608910|NCT02557399|144746629|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.8||||0.367|TWO_SIDED|95.0|-2.1|5.7||The analysis method was mixed-model for repeated measures with treatment, center, visit, treatment-by-visit interaction, Baseline non-ILs counts, Baseline-by-visit interaction as fixed effects.|mixed model repeated measures analysis||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 1 for non-ILs. A negative treatment difference indicates a benefit of Duac relative to ADA+CLDM.|||5.7|-2.1|0.367
72417435|NCT02130193|144345286|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.39|STANDARD_DEVIATION|0.4||0.22|TWO_SIDED|95.0|-1.12|0.43||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -0.7 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-cough, 8 month. Data presented are for 95% equal-tailed credible intervals|||0.43|-1.12|0.22
72325503|NCT03937479|144174466|SUPERIORITY||LS mean difference|0.0912|STANDARD_ERROR_OF_MEAN|0.03723||0.0148|TWO_SIDED|95.0|0.018|0.1643||The MMRM model was used to model the change from baseline FEV1 to peak FEV1 using treatment, visit and treatment by visit interaction as fixed effect, patient as random effect and baseline FEV1 as the covariate.|MMRM||Estimates refer to the Week 4 from treatment by visit interaction.|Comparison was done using a closed testing procedure; testing began at the highest dose of RPL554 compared with placebo. If found statistically significant then the next highest dose was compared with placebo. This continued until a result was found to be non-significant or all RPL554 doses were compared with placebo.||0.1643|0.0180|0.0148
72325504|NCT03937479|144174466|SUPERIORITY||LS mean difference|0.0775|STANDARD_ERROR_OF_MEAN|0.03697||0.0368|TWO_SIDED|95.0|0.0048|0.1501||The MMRM model was used to model the change from baseline FEV1 to peak FEV1 using treatment, visit and treatment by visit interaction as fixed effect, patient as random effect and baseline FEV1 as the covariate.|MMRM||Estimates refer to the Week 4 from treatment by visit interaction.|Comparison was done using a closed testing procedure; testing began at the highest dose of RPL554 compared with placebo. If found statistically significant then the next highest dose was compared with placebo. This continued until a result was found to be non-significant or all RPL554 doses were compared with placebo.||0.1501|0.0048|0.0368
72325505|NCT01854528|144174496|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|34.26|||<|0.001|TWO_SIDED|95.0|21.09|47.42|||Stratum adjusted Mantel-Haenszel|||P-value for the difference in sustained virologic response rates 12 weeks after the last dose between treatment groups with HCV subgenotype (1a, non-1a) from stratum adjusted Mantel-Haenszel with previous type of response to pegIFN/RBV treatment (relapser, partial or null responder) as strata.||47.42|21.09|<0.001
72325506|NCT01854528|144174497|SUPERIORITY_OR_OTHER||LS mean difference|8.64|||<|0.001|TWO_SIDED|95.0|5.43|11.85|||ANCOVA|||P-value from ANCOVA model including baseline score and region as covariates and treatment arm as a factor.||11.85|5.43|<0.001
72325507|NCT01854528|144174498|SUPERIORITY_OR_OTHER||LS mean difference|7.55|||<|0.001|TWO_SIDED|95.0|5.11|9.98|||ANCOVA|||P-value from ANCOVA model including baseline score and region as covariates and treatment arm as a factor.||9.98|5.11|<0.001
72325508|NCT01854528|144174499|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|54.7|||<|0.001|TWO_SIDED|95.0|6.9|435.1|||Regression, Logistic|||P-value from logistic regression model including treatment arm, baseline log10 HCV RNA level, HCV subgenotype, and previous response to pegIFN/RBV treatment as predictors.||435.1|6.9|<0.001
72325509|NCT01957865|144174519|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Linear and Poisson regressions|||In an intention-to-treat analysis, percentage doses taken each month were compared by linear generalized estimating equations (GEEs); more than 48-h and more than 96-h lapses in dosingwere compared by Poisson GEE regression.||||<0.05
72325510|NCT01957865|144174520|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Fisher's exact test|||HIV RNA suppression (\<100 copies/ml) was compared among study arms by Fisher's exact test.||||<0.05
72325511|NCT00811720|144174528|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.33|STANDARD_ERROR_OF_MEAN|0.75||0.002|TWO_SIDED|95.0|-3.81|-0.85|||Adjusted change from Baseline to Month 6||The Number of Participants Analyzed is participants with efficacy measurement available at this endpoint, that is, 213 participants in the placebo group and 152 participants in the nalmefene group.|"The primary hypothesis concerned the treatment effect at Month 6. The null hypothesis of no difference in treatment effect was tested against the alternative hypothesis that there was a difference in treatment effect.~MMRM model with the Baseline score as a covariate; site, sex, time in months (Month 1-6); and treatment as fixed effects. The Baseline score-by-time and treatment-by-time interactions were also included in the model. An unstructured covariance matrix was used."||-0.85|-3.81|0.002
72325512|NCT00811720|144174529|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.96|STANDARD_ERROR_OF_MEAN|2.98|<|0.001|TWO_SIDED|95.0|-16.81|-5.11|||Adjusted change from Baseline to Month 6||The Number of Participants Analyzed is participants with efficacy measurement available at this endpoint, that is, 213 participants in the placebo group and 152 participants in the nalmefene group.|"The primary hypothesis concerned the treatment effect at Month 6. The null hypothesis of no difference in treatment effect was tested against the alternative hypothesis that there was a difference in treatment effect.~MMRM model with the Baseline score as a covariate; site, sex, time in months (Month 1-6); and treatment as fixed effects. The Baseline score-by-time and treatment-by-time interactions were also included in the model. An unstructured covariance matrix was used."||-5.11|-16.81|<0.001
72325513|NCT00811720|144174530|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.7||||0.039|TWO_SIDED|95.0|0.5|0.98|||Adjusted Odds Ratio (OR) response|||The analysis of RSDRL used a logistic regression (LREG) model, with country, sex, Baseline DRL, and treatment as fixed effects, and missing values imputed as non-response.||0.98|0.50|0.039
72325514|NCT00811720|144174531|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.37|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.57|-0.16|||Adjusted change from Baseline to Week 24||The Number of Participants Analyzed is participants with efficacy measurement available at this endpoint, that is, 210 participants in the placebo group and 152 participants in the nalmefene group.|MMRM model with the Baseline score as a covariate, and site, sex, time in weeks, and treatment as fixed effects. The Baseline score-by-time and treatment-by-time interactions were also included in the model; an unstructured covariance matrix was used.||-0.16|-0.57|<0.001
72417436|NCT02130193|144345286|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.26|STANDARD_DEVIATION|0.41||0.14|TWO_SIDED|95.0|-1.07|0.52||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -0.7 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-cough, 9 month. Data presented are for 95% equal-tailed credible intervals|||0.52|-1.07|0.14
72417437|NCT02130193|144345286|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.53|STANDARD_DEVIATION|0.43||0.36|TWO_SIDED|95.0|-1.4|0.29||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -0.7 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-cough, 10 month. Data presented are for 95% equal-tailed credible intervals|||0.29|-1.40|0.36
72417438|NCT02130193|144345286|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.1|STANDARD_DEVIATION|0.41||0.07|TWO_SIDED|95.0|-0.89|0.69||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -0.7 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-cough, 11 month. Data presented are for 95% equal-tailed credible intervals|||0.69|-0.89|0.07
72417439|NCT02130193|144345286|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.3|STANDARD_DEVIATION|0.42||0.17|TWO_SIDED|95.0|-1.12|0.54||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -0.7 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-cough, 12 month. Data presented are for 95% equal-tailed credible intervals|||0.54|-1.12|0.17
72417440|NCT01297959|144345291|SUPERIORITY|||||||0.39|||||||Regression, Logistic|p-value was based on a logistic regression (Chi-square test) model with treatment group as a factor, adjusting for the stratification factors.||||||0.39
72417441|NCT01297959|144345292|SUPERIORITY|||||||0.34|||||||Regression, Logistic|p-value was based on a logistic regression (Chi-square test) model with treatment group as a factor, adjusting for the stratification factors.||||||0.34
72417442|NCT00707031|144345332|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was demonstrated if the upper limit of the 2-sided 95% confidence interval of the difference between lixisenatide and exenatide on mITT population was \<=0.4%.|Least squares (LS) mean difference|0.17|STANDARD_ERROR_OF_MEAN|0.067|||TWO_SIDED|95.0|0.033|0.297||Statistical testing: 2-sided at significance level=0.05. Analysis of co-variance (ANCOVA) included treatment arms, randomization strata of screening HbA1c (\<8.0, \>=8.0%), BMI (\<30, \>=30 kg/m\^2), country as fixed effects, baseline HbA1c as covariate.||||To detect that upper confidence limit of 2-sided 95% confidence interval for least square (LS) mean difference between the 2 arms do not exceed 0.4% HbA1c, 300 patients per group would provide 96% power assuming a standard deviation of 1.3 and true difference in HbA1c between the 2 arms as 0.||0.297|0.033|
72417443|NCT04154787|144345368|SUPERIORITY|Comparison of adjusted geometric mean ratios on Day 169|Adjusted geometric mean ratio|1.37||||0.267|TWO_SIDED|95.0|0.9|2.08||Calculated at one-sided 10% level from a lower-tailed test|Mixed Models Analysis|||||2.08|0.90|0.2670
72417444|NCT04154787|144345371|SUPERIORITY||Adjusted geometric mean ratios|0.81||||0.4598|TWO_SIDED|95.0|0.47|1.42||Calculated from a two-sided test at the 0.05 significance level|Mixed Model for Repeated Measures||Comparison of adjusted geometric mean ratios: Test vs Ref.|Day 15||1.42|0.47|0.4598
72417445|NCT04154787|144345371|SUPERIORITY||Geometric mean ratios|1.3||||0.4528|TWO_SIDED|95.0|0.65|2.61||Calculated from a two-sided test at the 0.05 significance level|Mixed Model for Repeated Measures||Comparison of adjusted geometric mean ratios: Test vs Ref.|Day 169||2.61|0.65|0.4528
72417446|NCT04171102|144345379|OTHER|||||||0.028||||||\<0.05|t-test, 2 sided|||||||0.028
72417447|NCT01712009|144345388|SUPERIORITY_OR_OTHER||Difference|-6.3|||||TWO_SIDED|95.0|-16.7|4.1|||||Naproxen minus No Prophylaxis|||4.1|-16.7|
72417448|NCT01712009|144345388|SUPERIORITY_OR_OTHER||Difference|-4.1|||||TWO_SIDED|95.0|-14.5|6.3|||||Loratadine minus No Prophylaxis|||6.3|-14.5|
72417449|NCT01712009|144345388|SUPERIORITY_OR_OTHER||Difference|2.2|||||TWO_SIDED|95.0|-8.0|12.4|||||Loratadine minus Naproxen|||12.4|-8.0|
72417450|NCT01712009|144345389|SUPERIORITY_OR_OTHER||Difference|-4.2|||||TWO_SIDED|95.0|-14.4|6.0|||||Naproxen minus No Prophylaxis|Difference across all treatment cycles||6.0|-14.4|
72417451|NCT01712009|144345389|SUPERIORITY_OR_OTHER||Difference|-2.4|||||TWO_SIDED|95.0|-12.5|7.8|||||Loratadine minus No Prophylaxis|Difference across all treatment cyces||7.8|-12.5|
72417452|NCT01712009|144345389|SUPERIORITY_OR_OTHER||Difference|1.8|||||TWO_SIDED|95.0|-8.3|12.0|||||Loratadine minus Naproxen|Dfference across all treatment cycles||12.0|-8.3|
72417453|NCT01712009|144345390|SUPERIORITY_OR_OTHER||Difference|-1.7|||||TWO_SIDED|95.0|-6.5|3.2|||||Naproxen minus No Prophylaxis|Difference across all treatment cycles||3.2|-6.5|
72417454|NCT01712009|144345390|SUPERIORITY_OR_OTHER||Difference|-1.3|||||TWO_SIDED|95.0|-6.1|3.6|||||Loratadine minus No Prophylaxis|Difference across all cycles||3.6|-6.1|
72417455|NCT01712009|144345390|SUPERIORITY_OR_OTHER||Difference|0.4|||||TWO_SIDED|95.0|-4.1|4.9|||||Loratadine minus Naproxen|Difference across all cycles||4.9|-4.1|
72417456|NCT01712009|144345391|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.2||0.0881|TWO_SIDED|95.0|-0.7|0.0|||ANOVA||Naproxen minus No Prophylaxis|Difference across all treatment cycles||0.0|-0.7|0.0881
72417457|NCT01712009|144345391|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4|STANDARD_DEVIATION|0.2||0.0443|TWO_SIDED|95.0|-0.7|0.0|||ANOVA||Loratadine minus No Prophylaxis|Difference across all treatment cycles||-0.0|-0.7|0.0443
72417458|NCT01712009|144345391|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.2||0.8007|TWO_SIDED|95.0|-0.4|0.3|||ANOVA||Loratadine minus Naproxen|Difference across all treatment cycles||0.3|-0.4|0.8007
72417459|NCT01712009|144345392|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.3||0.1466|TWO_SIDED|95.0|-1.1|0.2|||ANOVA||Naproxen minus No Prophylaxis|Difference across all treatment cycles||0.2|-1.1|0.1466
72608911|NCT02557399|144746629|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.1||||0.148|TWO_SIDED|95.0|-7.4|1.1||The analysis method was mixed-model for repeated measures with treatment, center, visit, treatment-by-visit interaction, Baseline non-ILs counts, Baseline-by-visit interaction as fixed effects.|mixed model repeated measures analysis||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 2 for non-ILs. A negative treatment difference indicates a benefit of Duac relative to ADA+CLDM.|||1.1|-7.4|0.148
72608912|NCT02557399|144746629|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.0||||0.314|TWO_SIDED|95.0|-5.9|1.9||The analysis method was mixed-model for repeated measures with treatment, center, visit, treatment-by-visit interaction, Baseline non-ILs counts, Baseline-by-visit interaction as fixed effects.|mixed model repeated measures analysis||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 4 for non-ILs. A negative treatment difference indicates a benefit of Duac relative to ADA+CLDM.|||1.9|-5.9|0.314
72608913|NCT02557399|144746629|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.2||||0.494|TWO_SIDED|95.0|-2.3|4.7||The analysis method was mixed-model for repeated measures with treatment, center, visit, treatment-by-visit interaction, Baseline non-ILs counts, Baseline-by-visit interaction as fixed effects.|mixed model repeated measures analysis||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 8 for non-ILs. A negative treatment difference indicates a benefit of Duac relative to ADA+CLDM.|||4.7|-2.3|0.494
72608914|NCT02557399|144746629|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.6||||0.684|TWO_SIDED|95.0|-3.5|2.3||The analysis method was mixed-model for repeated measures with treatment, center, visit, treatment-by-visit interaction, Baseline non-ILs counts, Baseline-by-visit interaction as fixed effects.|mixed model repeated measures analysis||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 12 for non-ILs. A negative treatment difference indicates a benefit of Duac relative to ADA+CLDM.|||2.3|-3.5|0.684
72608915|NCT02557399|144746630|SUPERIORITY_OR_OTHER||Difference in percentage|2.3||||0.047|TWO_SIDED|95.0|0.1|4.6||The P-value was based on the Cochran-Mantel-Haenszel test stratified by center.|Cochran-Mantel-Haenszel||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 1.The participants with missing data at a visit were included in the denominator (n) at the visit. That is, those participants were treated as non-responder at the visit.|||4.6|0.1|0.047
72608916|NCT02557399|144746630|SUPERIORITY_OR_OTHER||Difference in percentage|3.0||||0.185|TWO_SIDED|95.0|-1.3|7.3||The P-value was based on the Cochran-Mantel-Haenszel test stratified by center.|Cochran-Mantel-Haenszel||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 2. The participants with missing data at a visit were included in the denominator (n) at the visit. That is, those participants were treated as non-responder at the visit.|||7.3|-1.3|0.185
72608917|NCT02557399|144746630|SUPERIORITY_OR_OTHER||Difference in percentage|3.7||||0.251|TWO_SIDED|95.0|-2.5|9.9||The P-value was based on the Cochran-Mantel-Haenszel test stratified by center.|Cochran-Mantel-Haenszel||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 4. The participants with missing data at a visit were included in the denominator (n) at the visit. That is, those participants were treated as non-responder at the visit.|||9.9|-2.5|0.251
72608918|NCT02557399|144746630|SUPERIORITY_OR_OTHER||Difference in percentage|10.2||||0.006|TWO_SIDED|95.0|2.4|18.0||The P-value was based on the Cochran-Mantel-Haenszel test stratified by center.|Cochran-Mantel-Haenszel||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 8. The participants with missing data at a visit were included in the denominator (n) at the visit. That is, those participants were treated as non-responder at the visit.|||18.0|2.4|0.006
72608919|NCT02557399|144746630|SUPERIORITY_OR_OTHER||Difference in percentage|10.7||||0.022|TWO_SIDED|95.0|0.9|20.4||The P-value was based on the Cochran-Mantel-Haenszel test stratified by center.|Cochran-Mantel-Haenszel||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 12. The participants with missing data at a visit were included in the denominator (n) at the visit. That is, those participants were treated as non-responder at the visit.|||20.4|0.9|0.022
72608920|NCT02557399|144746631|SUPERIORITY_OR_OTHER||Difference in percentage|1.8||||0.129|TWO_SIDED|95.0|-0.7|4.3||The P-value was based on the Cochran-Mantel-Haenszel test stratified by center.|Cochran-Mantel-Haenszel||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 1. The participants with missing data at a visit were included in the denominator (n) at the visit. That is, those participants were treated as non-responder at the visit.|||4.3|-0.7|0.129
72608921|NCT02557399|144746631|SUPERIORITY_OR_OTHER||Difference in percentage|1.3||||0.612|TWO_SIDED|95.0|-3.4|5.9||The P-value was based on the Cochran-Mantel-Haenszel test stratified by center.|Cochran-Mantel-Haenszel||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 2. The participants with missing data at a visit were included in the denominator (n) at the visit. That is, those participants were treated as non-responder at the visit.|||5.9|-3.4|0.612
72608922|NCT02557399|144746631|SUPERIORITY_OR_OTHER||Difference in percentage|7.1||||0.016|TWO_SIDED|95.0|1.1|13.2||The P-value was based on the Cochran-Mantel-Haenszel test stratified by center.|Cochran-Mantel-Haenszel||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 4. The participants with missing data at a visit were included in the denominator (n) at the visit. That is, those participants were treated as non-responder at the visit.|||13.2|1.1|0.016
72608923|NCT02557399|144746631|SUPERIORITY_OR_OTHER||Difference in percentage|7.9||||0.034|TWO_SIDED|95.0|0.3|15.5||The P-value was based on the Cochran-Mantel-Haenszel test stratified by center.|Cochran-Mantel-Haenszel||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 8. The participants with missing data at a visit were included in the denominator (n) at the visit. That is, those participants were treated as non-responder at the visit.|||15.5|0.3|0.034
72417460|NCT01712009|144345392|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.3||0.0411|TWO_SIDED|95.0|-1.3|0.0|||ANOVA||Loratadine minus No Prophylaxis|Difference across all treatment cycles||-0.0|-1.3|0.0411
72417461|NCT01712009|144345392|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.3||0.5689|TWO_SIDED|95.0|-0.8|0.5|||ANOVA||Loratadine minus Naproxen|Difference across all treatment cycles||0.5|-0.8|0.5689
72417462|NCT01712009|144345393|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.4|STANDARD_ERROR_OF_MEAN|0.8||0.0775||95.0|-3.0|0.2|||ANOVA||Naproxen minus No Prophylaxis|Difference across all treatment cycles||0.2|-3.0|0.0775
72417463|NCT01712009|144345393|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.6|STANDARD_ERROR_OF_MEAN|0.8||0.0329|TWO_SIDED|95.0|-3.1|-0.1|||ANCOVA||Loratadine minus No Prophylaxis|Difference across all treatment cycles||-0.1|-3.1|0.0329
72417464|NCT01712009|144345393|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.7||0.7572|TWO_SIDED|95.0|-1.7|1.2|||ANOVA||Loratadine minus Naproxen|Difference across all treatment groups||1.2|-1.7|0.7572
72417465|NCT01986881|144345435|NON_INFERIORITY|1-sided p-value and the non-inferiority margin is a hazard ratio of 1.3.|Hazard Ratio (HR)|0.97|||<|0.001|TWO_SIDED|95.6|0.848|1.114||Model included treatment as an explanatory factor and cohort category as a stratification factor.|Cox Proportional Hazards Model|||||1.114|0.848|<0.001
72417466|NCT01986881|144345435|NON_INFERIORITY|1-sided p-value and the non-inferiority margin is a hazard ratio of 1.3.|Hazard Ratio (HR)|1.04||||0.002|TWO_SIDED|95.6|0.887|1.211|||Cox Proportional Hazards Model|Model included treatment as an explanatory factor and cohort category as a stratification factor.||||1.211|0.887|0.002
72417467|NCT01986881|144345435|NON_INFERIORITY|1-sided p-value and the non-inferiority margin is a hazard ratio of 1.3.|Hazard Ratio (HR)|0.91|||<|0.001|TWO_SIDED|95.6|0.773|1.065|||Cox Proportional Hazards Model|Model included treatment as an explanatory factor and cohort category as a stratification factor.||||1.065|0.773|<0.001
72417468|NCT01986881|144345437|SUPERIORITY||Difference in the Least Squares Means|-0.65|||<|0.001|TWO_SIDED|95.0|-0.78|-0.51||"Constrained longitudinal data analysis (cLDA) model with fixed effects for treatment, time, baseline eGFR, stratum, and the interaction of time by treatment. The stratum was (insulin alone or insulin+metformin) and Time was a categorical variable."|cLDA Model|||||-0.51|-0.78|<0.001
72417469|NCT01986881|144345437|SUPERIORITY||Difference in the Least Squares Means|-0.58|||<|0.001|TWO_SIDED|95.0|-0.71|-0.44||"Constrained longitudinal data analysis (cLDA) model with fixed effects for treatment, time, baseline eGFR, stratum, and the interaction of time by treatment. The stratum was (insulin alone or insulin+metformin) and Time was a categorical variable."|Constrained longitudinal data analysis|||||-0.44|-0.71|<0.001
72417470|NCT01986881|144345439|SUPERIORITY||Difference in the Least Squares Means|-0.22||||0.247|TWO_SIDED|95.0|-0.6|0.16||Constrained longitudinal data analysis (cLDA) model with fixed effects for treatment, time, baseline eGFR, and the interaction of time by treatment.|cLDA Model|||||0.16|-0.60|0.247
72417471|NCT01986881|144345439|SUPERIORITY||Difference in the Least Squares Means|-0.35||||0.063|TWO_SIDED|95.0|-0.72|0.02||Constrained longitudinal data analysis (cLDA) model with fixed effects for treatment, time, baseline eGFR, and the interaction of time by treatment.|cLDA model|||||0.02|-0.72|0.063
72608924|NCT02557399|144746631|SUPERIORITY_OR_OTHER||Difference in percentage|11.3||||0.018|TWO_SIDED|95.0|1.4|21.3||The P-value was based on the Cochran-Mantel-Haenszel test stratified by center.|Cochran-Mantel-Haenszel||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 12. The participants with missing data at a visit were included in the denominator (n) at the visit. That is, those participants were treated as non-responder at the visit.|||21.3|1.4|0.018
72417472|NCT01986881|144345441|SUPERIORITY||Difference in the Least Squares Means|-0.75|||<|0.001|TWO_SIDED|95.0|-0.98|-0.53||Constrained longitudinal data analysis (cLDA) model with fixed effects for treatment, time, baseline eGFR, and the interaction of time by treatment.|cLDA Model|||||-0.53|-0.98|<0.001
72417473|NCT01986881|144345441|SUPERIORITY||Difference in the Least Squares Means|-0.66|||<|0.001|TWO_SIDED|95.0|-0.89|-0.43||Constrained longitudinal data analysis (cLDA) model with fixed effects for treatment, time, baseline eGFR, and the interaction of time by treatment.|cLDA model|||||-0.43|-0.89|<0.001
72417474|NCT01986881|144345442|SUPERIORITY||Hazard Ratio (HR)|0.88||||0.108|TWO_SIDED|95.8|0.75|1.034|||Cox Proportional Hazards Model|Model included treatment as an explanatory factor and cohort category as a stratification factor.||||1.034|0.750|0.108
72417475|NCT01986881|144345442|SUPERIORITY||Hazard Ratio (HR)|0.88||||0.15|TWO_SIDED|95.8|0.725|1.057|||Cox Proportional Hazards Model|Model included treatment as an explanatory factor and cohort category as a stratification factor.||||1.057|0.725|0.150
72417476|NCT01986881|144345442|SUPERIORITY||Hazard Ratio (HR)|0.89||||0.188|TWO_SIDED|95.8|0.735|1.068|||Cox Proportional Hazards Model|Model included treatment as an explanatory factor and cohort category as a stratification factor.||||1.068|0.735|0.188
72417477|NCT01986881|144345443|SUPERIORITY||Hazard Ratio (HR)|0.92||||0.385|TWO_SIDED|95.8|0.767|1.113|||Cox Proportional Hazards Model|Model included treatment as an explanatory factor and cohort category as a stratification factor.||||1.113|0.767|0.385
72417478|NCT01986881|144345443|SUPERIORITY||Hazard Ratio (HR)|0.92||||0.417|TWO_SIDED|95.8|0.739|1.139|||Cox Proportional Hazards Model|Model included treatment as an explanatory factor and cohort category as a stratification factor.||||1.139|0.739|0.417
72417479|NCT01986881|144345443|SUPERIORITY||Hazard Ratio (HR)|0.93||||0.494|TWO_SIDED|95.8|0.75|1.154|||Cox Proportional Hazards Model|Model included treatment as an explanatory factor and cohort category as a stratification factor.||||1.154|0.750|0.494
72417480|NCT01986881|144345444|SUPERIORITY||Hazard Ratio (HR)|0.81||||0.081|TWO_SIDED|95.8|0.63|1.036|||Cox Proportional Hazards Model|Model included treatment as an explanatory factor and cohort category as a stratification factor.||||1.036|0.630|0.081
72417481|NCT01986881|144345444|SUPERIORITY||Hazard Ratio (HR)|0.85||||0.258|TWO_SIDED|95.8|0.638|1.137|||Cox Proportional Hazard Model|"Model included treatment as an explanatory factor and cohort category as a stratification factor.~Renal"||||1.137|0.638|0.258
72608925|NCT02557399|144746632|SUPERIORITY_OR_OTHER||Difference in percentage|3.9||||0.379|TWO_SIDED|95.0|-4.5|12.3||The P-value was based on the Cochran-Mantel-Haenszel test stratified by center.|Cochran-Mantel-Haenszel||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 1 for TLs. The participants with missing data at a visit were included in the denominator (n) at the visit. That is, those participants were treated as non-responder at the visit.|||12.3|-4.5|0.379
72325515|NCT00811720|144174532|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.34|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.53|-0.15|||Adjusted change from Baseline to Week 24||The Number of Participants Analyzed is participants with efficacy measurement available at this endpoint, that is, 210 participants in the placebo group and 152 participants in the nalmefene group.|MMRM model with the Baseline CGI-S score as a covariate, and site, sex, time in weeks, and treatment as fixed effects. The Baseline CGI-S score-by-time and treatment-by-time interactions were also included in the model. An unstructured covariance matrix was used.||-0.15|-0.53|<0.001
72325516|NCT00811720|144174533|SUPERIORITY_OR_OTHER||Ratio to placebo|0.88||||0.009|TWO_SIDED|95.0|0.8|0.97|||Adjusted values||The Number of Participants Analyzed is participants with efficacy measurement available at this endpoint, that is, 211 participants in the placebo group and 158 participants in the nalmefene group.|Log-transformed GGT values were analysed using an MMRM model with the log-transformed Baseline value as a covariate, and site, sex, time in weeks, and treatment as fixed effects. Log-transformed Baseline value-by-time interaction and treatment-by-time interaction were included in the model. An unstructured covariance matrix was used.||0.97|0.80|0.009
72325517|NCT00811720|144174534|SUPERIORITY_OR_OTHER||Ratio to placebo|0.9||||0.011|TWO_SIDED|95.0|0.84|0.98|||Adjusted values||The Number of Participants Analyzed is participants with efficacy measurement available at this endpoint, that is, 209 participants in the placebo group and 158 participants in the nalmefene group.|Log-transformed ALAT values were analysed using an MMRM model with the log-transformed Baseline value as a covariate, and site, sex, time in weeks, and treatment as fixed effects. Log-transformed Baseline value-by-time and treatment-by-time interactions were included in the model. An unstructured covariance matrix was used.||0.98|0.84|0.011
72325518|NCT01044030|144174583|SUPERIORITY_OR_OTHER|||||||0.6|TWO_SIDED||||||Chi-squared|||||||0.6
72325519|NCT02099084|144174647|SUPERIORITY_OR_OTHER|||||||0.74|TWO_SIDED||||||t-test, 2 sided|||Level of significance = .05||||0.74
72325520|NCT02099084|144174648|SUPERIORITY_OR_OTHER|||||||0.2|TWO_SIDED||||||t-test, 2 sided|||Comparison between the groups for change between 0- and 2-hours. Level of significance = .05||||0.20
72325521|NCT02099084|144174648|SUPERIORITY_OR_OTHER|||||||0.17|TWO_SIDED||||||t-test, 2 sided|||Comparison between the groups for change between 0- and 8-hours. Level of significance = .05||||0.17
72325522|NCT02099084|144174649|SUPERIORITY_OR_OTHER|||||||0.075|TWO_SIDED||||||t-test, 2 sided|||Level of significance = .05||||0.075
72417482|NCT01986881|144345444|SUPERIORITY||Hazard Ratio (HR)|0.76||||0.065|TWO_SIDED|95.8|0.568|1.028|||Cox Proportional Hazards Model|Model included treatment as an explanatory factor and cohort category as a stratification factor.||||1.028|0.568|0.065
72417483|NCT01986881|144345445|SUPERIORITY||Hazard Ratio (HR)|0.92||||0.183|TWO_SIDED|95.0|0.823|1.038||Hazard ratio, CI, and 2-sided p-value comparing All Ertugliflozin versus Placebo, based on the stratified Cox proportional hazards model that included treatment as an explanatory factor and cohort category as a stratification factor.|Cox proportional hazards model|||||1.038|0.823|0.183
72325523|NCT02099084|144174652|SUPERIORITY_OR_OTHER|||||||0.42|TWO_SIDED||||||t-test, 2 sided|||Level of significance = .05||||0.42
72417484|NCT01986881|144345445|SUPERIORITY||Hazard Ratio (HR)|0.95||||0.45|TWO_SIDED|95.0|0.831|1.086|||Cox Proportional Hazards Model|Model included treatment as an explanatory factor and cohort category as a stratification factor.||||1.086|0.831|0.450
72417485|NCT01986881|144345445|SUPERIORITY||Hazard Ratio (HR)|0.9||||0.123|TWO_SIDED|95.0|0.785|1.029|||Cox Proportional Hazards Model|Model included treatment as an explanatory factor and cohort category as a stratification factor.||||1.029|0.785|0.123
72417486|NCT01986881|144345446|SUPERIORITY||Hazard Ratio (HR)|1.04||||0.676|TWO_SIDED|95.0|0.861|1.259|||Cox Proportional Hazards Model|Model included treatment as an explanatory factor and cohort category as a stratification factor.||||1.259|0.861|0.676
72417487|NCT01986881|144345446|SUPERIORITY||Hazard Ratio (HR)|1.17||||0.139|TWO_SIDED|95.0|0.949|1.451|||Cox Proportional Hazards Model|Model included treatment as an explanatory factor and cohort category as a stratification factor.||||1.451|0.949|0.139
72417488|NCT01986881|144345446|SUPERIORITY||Hazard Ratio (HR)|0.91||||0.416|TWO_SIDED|95.0|0.727|1.141|||Cox Proportional Hazards Model|Model included treatment as an explanatory factor and cohort category as a stratification factor.||||1.141|0.727|0.416
72417489|NCT01986881|144345447|SUPERIORITY||Hazard Ratio (HR)|1.06||||0.663|TWO_SIDED|95.0|0.82|1.365||Hazard ratio, CI, and 2-sided p-value comparing All Ertugliflozin versus Placebo, based on the stratified Cox proportional hazards model that included treatment as an explanatory factor and cohort category as a stratification factor.|Cox proportional hazards model||Hazard ratio, CI, and 2-sided p-value comparing All Ertugliflozin versus Placebo, based on the stratified Cox proportional hazards model that included treatment as an explanatory factor and cohort category as a stratification factor.|||1.365|0.820|0.663
72325524|NCT02099084|144174653|SUPERIORITY_OR_OTHER|||||||0.34|TWO_SIDED||||||t-test, 2 sided|||Level of significance = .05||||0.34
72325525|NCT01205503|144174654|SUPERIORITY_OR_OTHER|||||||0.014|TWO_SIDED|||||This is for the interaction between baseline tnf-alpha levels and treatment received (mesna vs saline).|Mixed Models Analysis|Model was adjusted for baseline biochemical measures, time of measurement, treatment (mesna or saline), chemo type, and first-order interactions.||||||0.014
72325526|NCT01953211|144174663|SUPERIORITY_OR_OTHER||Slope|0.02|STANDARD_DEVIATION|0.57||0.88|TWO_SIDED||||||t-test, 2 sided|||||||0.88
72325527|NCT01953211|144174663|SUPERIORITY_OR_OTHER||Slope|0.63|STANDARD_DEVIATION|0.9|<|0.01|TWO_SIDED||||||t-test, 2 sided|||||||<0.01
72325528|NCT01953211|144174663|SUPERIORITY_OR_OTHER||Slope|0.83|STANDARD_DEVIATION|0.78|<|0.01|TWO_SIDED||||||t-test, 2 sided|||||||<0.01
72325529|NCT03188263|144174664|OTHER|The primary planned analysis was in bright light group only and compared pre-post measurements.||||||0.046||||||A threshold of .05 was selected a priori.|Sign test|A Wilcoxon matched-pairs signed-ranks test was estimated to determine if pre-post measures of glucose levels differed significantly.||The primary planned analyses was to examine effect in bright light group. A significance level of .05 was selected a priori.||||.046
72325530|NCT03188263|144174665|OTHER|The primary planned analysis was in bright light group only and compared pre-post measurements.||||||0.35||||||A threshold of .05 was selected a priori.|Sign test|A Wilcoxon matched-pairs signed-ranks test was estimated to determine if pre-post measures of glucose levels differed significantly.||The primary planned analyses was to examine effect in bright light group. A significance level of .05 was selected a priori.||||.35
72417490|NCT01986881|144345447|SUPERIORITY||Hazard Ratio (HR)|1.13||||0.415|TWO_SIDED|95.0|0.845|1.505||A two-sided p-value compared Ertugliflozin vs Placebo, based on the stratified Cox proportional hazards model that included treatment as an explanatory factor and cohort category as a stratification factor.|Cox proportional hazards model|||Hazard ratio, confidence interval, and two-sided p-value comparing Ertugliflozin vs Placebo, based on the stratified Cox proportional hazards model that includes treatment as an explanatory factor and cohort category as a stratification factor.||1.505|0.845|0.415
72417491|NCT01986881|144345447|SUPERIORITY||Hazard Ratio (HR)|0.99||||0.953|TWO_SIDED|95.0|0.736|1.334||A two-sided p-value compared Ertugliflozin vs Placebo, based on the stratified Cox proportional hazards model that included treatment as an explanatory factor and cohort category as a stratification factor.|Cox proportional hazards model|||Hazard ratio, confidence interval, and two-sided p-value comparing Ertugliflozin vs Placebo, based on the stratified Cox proportional hazards model that includes treatment as an explanatory factor and cohort category as a stratification factor.||1.334|0.736|0.953
72417492|NCT01986881|144345448|SUPERIORITY||Hazard Ratio (HR)|0.7||||0.006|TWO_SIDED|95.0|0.539|0.902||Hazard ratio, CI, and 2-sided p-value comparing All Ertugliflozin versus Placebo, based on the stratified Cox proportional hazards model that included treatment as an explanatory factor and cohort category as a stratification factor.|Cox proportional hazards model|||||0.902|0.539|0.006
72417493|NCT01986881|144345448|SUPERIORITY||Hazard Ratio (HR)|0.68||||0.016|TWO_SIDED|95.0|0.502|0.932|||Cox Proportional Hazards Model|Hazards model that included treatment as an explanatory factor and cohort category as a stratification factor.||||0.932|0.502|0.016
72417494|NCT01986881|144345448|SUPERIORITY||Hazard Ratio (HR)|0.71||||0.028|TWO_SIDED|95.0|0.524|0.964|||Cox Proportional Hazards Model|Hazards model that included treatment as an explanatory factor and cohort category as a stratification factor.||||0.964|0.524|0.028
72417495|NCT01986881|144345449|SUPERIORITY|Hazard ratio, CI, and 2-sided p-value comparing Ertugliflozin vs Placebo, based on the stratified Cox proportional hazards model that included treatment as an explanatory factor and cohort category as a stratification factor. The on-study approach included confirmed events that occurred between the randomization date and the on-study censor date.|Hazard Ratio (HR)|0.93||||0.34|TWO_SIDED|95.0|0.797|1.081||Hazard ratio, CI, and 2-sided p-value comparing Ertugliflozin vs Placebo, based on the stratified Cox proportional hazards model that included treatment as an explanatory factor and cohort category as a stratification factor.|Cox proportional hazards model|||||1.081|0.797|0.340
72417496|NCT01986881|144345449|SUPERIORITY||Hazard Ratio (HR)|0.94||||0.463|TWO_SIDED|95.0|0.784|1.117|||Cox Proportional Hazards Model|Model included treatment as an explanatory factor and cohort category as a stratification factor.||||1.117|0.784|0.463
72417497|NCT01986881|144345449|SUPERIORITY||Hazard Ratio (HR)|0.92||||0.363|TWO_SIDED|95.0|0.771|1.1|||Cox Proportional Hazards Model|Model included treatment as an explanatory factor and cohort category as a stratification factor.||||1.100|0.771|0.363
72608926|NCT02557399|144746632|SUPERIORITY_OR_OTHER||Difference in percentage|4.7||||0.409|TWO_SIDED|95.0|-5.7|15.1||The P-value was based on the Cochran-Mantel-Haenszel test stratified by center.|Cochran-Mantel-Haenszel||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 2 for TLs. The participants with missing data at a visit were included in the denominator (n) at the visit. That is, those participants were treated as non-responder at the visit.|||15.1|-5.7|0.409
72417498|NCT01986881|144345450|SUPERIORITY|Ertugliflozin vs Placebo, based on the Andersen-Gill model for the recurrent events at the end of study. The on-study approach includes confirmed events that occurred between the randomization date and the on-study censor date.|Hazard Ratio (HR)|1.01|||||TWO_SIDED|95.0|0.898|1.131||||||||1.131|0.898|
72417499|NCT01986881|144345450|SUPERIORITY||Hazard Ratio (HR)|1.07|||||TWO_SIDED|95.0|0.937|1.219||||||||1.219|0.937|
72417500|NCT01986881|144345450|SUPERIORITY||Hazard Ratio (HR)|0.95|||||TWO_SIDED|95.0|0.828|1.085||||||||1.085|0.828|
72417501|NCT01986881|144345451|SUPERIORITY||Hazard Ratio (HR)|0.82|||||TWO_SIDED|95.0|0.716|0.945||||||Ertugliflozin vs Placebo, based on the Andersen-Gill model for the recurrent events at the end of study. The on-study approach included confirmed events that occurred between randomization date and the on-study censor date.||0.945|0.716|
72417502|NCT01986881|144345451|SUPERIORITY||Hazard Ratio (HR)|0.79|||||TWO_SIDED|95.0|0.673|0.935|||||Ertugliflozin vs Placebo, based on the Andersen-Gill model for the recurrent events at the end of study.|||0.935|0.673|
72417503|NCT01986881|144345451|SUPERIORITY||Hazard Ratio (HR)|0.85|||||TWO_SIDED|95.0|0.725|1.001|||||Ertugliflozin vs Placebo, based on the Andersen-Gill model for the recurrent events at the end of study.|||1.001|0.725|
72417504|NCT01986881|144345452|SUPERIORITY||Difference in the Least Squares Means|-0.5|||<|0.001|TWO_SIDED|95.0|-0.55|-0.46|||cLDA Model|cLDA model with fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment.||||-0.46|-0.55|<0.001
72417505|NCT01986881|144345452|SUPERIORITY||Difference in the Least Squares Means|-0.48|||<|0.001|TWO_SIDED|95.0|-0.53|-0.44|||cLDA model|cLDA model with fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment.||||-0.44|-0.53|<0.001
72417506|NCT01986881|144345453|SUPERIORITY||Difference in the Least Squares Means|-0.48|||<|0.001|TWO_SIDED|95.0|-0.54|-0.43|||Constrained Longitudinal Data Analysis|Model included fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment.||||-0.43|-0.54|<0.001
72417507|NCT01986881|144345453|SUPERIORITY||Difference in the Least Squares Means|-0.5|||<|0.001|TWO_SIDED|95.0|-0.55|-0.45|||Constrained Longitudinal Data Analysis|Model included fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment.||||-0.45|-0.55|<0.001
72608927|NCT02557399|144746632|SUPERIORITY_OR_OTHER||Difference in percentage|7.0||||0.18|TWO_SIDED|95.0|-3.1|17.0||The P-value was based on the Cochran-Mantel-Haenszel test stratified by center.|Cochran-Mantel-Haenszel||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 4 for TLs. The participants with missing data at a visit were included in the denominator (n) at the visit. That is, those participants were treated as non-responder at the visit.|||17.0|-3.1|0.180
72325531|NCT00539240|144174685|SUPERIORITY_OR_OTHER|||||||0.04||||||P\<0.05 considered statistically significant. No adjustment for multiple comparisons|Regression, Linear|adjusted for age, sex, BMI and ethnicity||||||0.04
72325532|NCT00539240|144174685|SUPERIORITY_OR_OTHER|||||||0.5||||||P\<0.05 considered statistically significant, No adjustment for multiple comparisons|Regression, Linear|adjusted for age, sex, BMI and ethnicity||||||0.50
72325533|NCT00539240|144174686|SUPERIORITY_OR_OTHER|||||||0.19||||||P\<0.05 considered statistically significant. No adjustment for multiple comparisons (no post-hoc contrasts performed)|ANCOVA|Adjusted for baseline score and personality traits (SCL-90)||||||0.19
72325534|NCT00539240|144174687|SUPERIORITY_OR_OTHER|||||||0.04||||||P\<0.05 considered statistically significant, No adjustment for multiple comparisons|Regression, Linear|adjusted for age, sex, BMI and ethnicity.||||||0.04
72325535|NCT00539240|144174687|SUPERIORITY_OR_OTHER|||||||0.5||||||P\<0.05 considered statistically significant, no adjustment for multiple comparisons|Regression, Linear|adjusted for age, sex, BMI and ethnicity||||||0.50
72325536|NCT00539240|144174688|SUPERIORITY_OR_OTHER|||||||0.04||||||P\<0.05 considered statistically significant. No adjustment for multiple comparisons.|Regression, Linear|adjusted for age, sex, BMI and ethnicity||||||0.04
72417508|NCT01986881|144345454|SUPERIORITY||Difference in the least squares means|-0.37|||<|0.001|TWO_SIDED|95.0|-0.45|-0.3||Constrained longitudinal data analysis (cLDA) model with fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.|Constrained longitudinal data analysis||Ertugliflozin vs. Placebo|||-0.30|-0.45|<0.001
72325537|NCT00539240|144174688|SUPERIORITY_OR_OTHER|||||||0.2||||||P\<0.05 considered statistically significant. No adjustment for multiple comparisons.|Regression, Linear|adjusted for age, sex, BMI and ethnicity.||||||0.20
72325538|NCT02765399|144174691|OTHER|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||||||0.001
72325539|NCT02765399|144174691|OTHER|||||||0.028|||||||Wilcoxon (Mann-Whitney)|||||||0.028
72325540|NCT02765399|144174692|OTHER|||||||0.011|||||||Wilcoxon (Mann-Whitney)|||||||0.011
72325541|NCT02765399|144174692|OTHER|||||||0.612|||||||Wilcoxon (Mann-Whitney)|||||||0.612
72325542|NCT02765399|144174693|OTHER|||||||0.002|||||||Wilcoxon (Mann-Whitney)|||||||0.002
72325543|NCT02765399|144174693|OTHER|||||||0.128|||||||Wilcoxon (Mann-Whitney)|||||||0.128
72325544|NCT02765399|144174694|OTHER|||||||0.005|||||||Wilcoxon (Mann-Whitney)|||||||0.005
72325545|NCT02765399|144174694|OTHER|||||||0.343|||||||Wilcoxon (Mann-Whitney)|||||||0.343
72325546|NCT02765399|144174695|OTHER|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||||||0.001
72325547|NCT02765399|144174695|OTHER|||||||0.865|||||||Wilcoxon (Mann-Whitney)|||||||0.865
72325548|NCT02765399|144174696|OTHER|||||||0.532|||||||Wilcoxon (Mann-Whitney)|||||||0.532
72325549|NCT02765399|144174696|OTHER|||||||0.735|||||||Wilcoxon (Mann-Whitney)|||||||0.735
72325550|NCT02765399|144174697|OTHER|||||||0.017|||||||Wilcoxon (Mann-Whitney)|||||||0.017
72325551|NCT02765399|144174697|OTHER|||||||0.753|||||||Wilcoxon (Mann-Whitney)|||||||0.753
72325552|NCT02765399|144174698|OTHER|||||||0.047|||||||Wilcoxon (Mann-Whitney)|||||||0.047
72325553|NCT02765399|144174698|OTHER|||||||0.499|||||||Wilcoxon (Mann-Whitney)|||||||0.499
72325554|NCT02765399|144174699|OTHER|||||||0.004|||||||Wilcoxon (Mann-Whitney)|||||||0.004
72325555|NCT02765399|144174699|OTHER|||||||0.128|||||||Wilcoxon (Mann-Whitney)|||||||0.128
72325556|NCT02765399|144174700|OTHER|||||||0.018|||||||Wilcoxon (Mann-Whitney)|||||||0.018
72325557|NCT02765399|144174700|OTHER|||||||0.578|||||||Wilcoxon (Mann-Whitney)|||||||0.578
72325558|NCT02765399|144174701|OTHER|||||||0.152|||||||Wilcoxon (Mann-Whitney)|||||||0.152
72325559|NCT02765399|144174701|OTHER|||||||0.866|||||||Wilcoxon (Mann-Whitney)|||||||0.866
72325560|NCT02765399|144174702|OTHER|||||||0.173|||||||Wilcoxon (Mann-Whitney)|||||||0.173
72325561|NCT02765399|144174702|OTHER|||||||0.018|||||||Wilcoxon (Mann-Whitney)|||||||0.018
72325562|NCT02765399|144174703|OTHER|||||||0.002|||||||Wilcoxon (Mann-Whitney)|||||||0.002
72325563|NCT02765399|144174703|OTHER|||||||1|||||||Wilcoxon (Mann-Whitney)|||||||1
72325564|NCT02765399|144174704|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
72325565|NCT02765399|144174704|OTHER|||||||0.79|||||||Wilcoxon (Mann-Whitney)|||||||0.79
72325566|NCT02765399|144174705|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
72325567|NCT02765399|144174705|OTHER|||||||0.13|||||||Wilcoxon (Mann-Whitney)|||||||0.13
72325568|NCT02765399|144174706|OTHER|||||||0.011|||||||Wilcoxon (Mann-Whitney)|||||||0.011
72325569|NCT02765399|144174706|OTHER|||||||0.13|||||||Wilcoxon (Mann-Whitney)|||||||0.13
72325570|NCT02765399|144174707|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
72325571|NCT02765399|144174707|OTHER|||||||0.13|||||||Wilcoxon (Mann-Whitney)|||||||0.13
72325572|NCT02765399|144174708|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
72325573|NCT02765399|144174708|OTHER|||||||0.79|||||||Wilcoxon (Mann-Whitney)|||||||0.79
72325574|NCT02765399|144174709|OTHER|||||||0.017|||||||Wilcoxon (Mann-Whitney)|||||||0.017
72325575|NCT02765399|144174709|OTHER|||||||0.79|||||||Wilcoxon (Mann-Whitney)|||||||0.79
72325576|NCT02765399|144174710|OTHER|||||||0.017|||||||Wilcoxon (Mann-Whitney)|||||||0.017
72325577|NCT02765399|144174710|OTHER|||||||0.18|||||||Wilcoxon (Mann-Whitney)|||||||0.18
72325578|NCT02765399|144174711|OTHER|||||||0.068|||||||Wilcoxon (Mann-Whitney)|||||||0.068
72325579|NCT02765399|144174711|OTHER|||||||0.63|||||||Wilcoxon (Mann-Whitney)|||||||0.63
72325580|NCT00768261|144174713|OTHER|||||||0.095|TWO_SIDED|95.0|||||ANOVA|df= 3,92||||||0.095
72325581|NCT00768261|144174714|OTHER|||||||0.066|TWO_SIDED|95.0|||||ANOVA|||"There would be a treatment effect on the changes of hippocampal measures over time.~Repeated measures ANOVA on hippocampal volume slopes with hemisphere as a within-subject repeated factor, and treatment group as the main effect."||||0.066
72325582|NCT00768261|144174714|OTHER|||||||0.009|TWO_SIDED|95.0|||||ANOVA|||"There would be a treatment effect on the changes of hippocampal measures over time.~Repeated measures ANOVA on hippocampal volume slopes with hemisphere as a within-subject repeated factor, and treatment group as the main effect."||||0.009
72325583|NCT00768261|144174714|OTHER|||||||0.3|TWO_SIDED|95.0|||||ANOVA|||"There would be a treatment effect on the changes of hippocampal measures over time.~Repeated measures ANOVA on hippocampal volume slopes with hemisphere as a within-subject repeated factor, and treatment group as the main effect."||||0.30
72325584|NCT00768261|144174714|OTHER|||||||0.0288|TWO_SIDED|95.0|||||Repeated Measures ANOVA|||RM-ANOVA on hippocampal volume slope||||0.0288
72417509|NCT01986881|144345454|SUPERIORITY||Difference in Least Squares Means|-0.39|||<|0.001|TWO_SIDED|95.0|-0.46|-0.32||Constrained longitudinal data analysis (cLDA) model with fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.|cLDA|Ertugliflozin vs. Placebo.||||-0.32|-0.46|<0.001
72417510|NCT01986881|144345456|SUPERIORITY||Difference in the least squares means|-0.31||||0.001|TWO_SIDED|95.0|-0.41|-0.21||Constrained longitudinal data analysis (cLDA) model with fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.|cLDA|||||-0.21|-0.41|0.001
72417511|NCT01986881|144345456|SUPERIORITY||Difference in the least squares means|-0.36|||<|0.001|TWO_SIDED|95.0|-0.46|-0.26||Constrained longitudinal data analysis (cLDA) model with fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.|cLDA model|||||-0.26|-0.46|<0.001
72417512|NCT01986881|144345471|SUPERIORITY||Difference in the Least Squares Means|-17.56|||<|0.001|TWO_SIDED|95.0|-19.49|-15.63|||CLDA|cLDA model with fixed effects for treatment, time, baseline eGFR (continuous), and the interaction of time by treatment.||||-15.63|-19.49|<0.001
72417513|NCT01986881|144345471|SUPERIORITY||Difference in the Least Squares Means|-15.1|||<|0.001|TWO_SIDED|95.0|-17.03|-13.17|||cLDA|cLDA model with fixed effects for treatment, time, baseline eGFR (continuous), and the interaction of time by treatment.||||-13.17|-17.03|<0.001
72417514|NCT01986881|144345478|SUPERIORITY||||||<|0.001|||||||Log Rank|Log-Rank Test for the comparison to Placebo was based on all data (including for those participants who never had the event).||||||<0.001
72417515|NCT01986881|144345478|SUPERIORITY||||||<|0.001|||||||Log Rank|Log-Rank Test for the comparison to Placebo was based on all data (including for those participants who never had the event).||||||<0.001
72417516|NCT01986881|144345479|SUPERIORITY||||||<|0.001|||||||Log Rank|Log-Rank Test for the comparison to Placebo was based on all data (including for those participants who never had the event).||||||<0.001
72417517|NCT01986881|144345479|SUPERIORITY||||||<|0.001|||||||Log Rank|Log-Rank Test for the comparison to Placebo was based on all data (including for those participants who never had the event).||||||<0.001
72417518|NCT01986881|144345487|SUPERIORITY||Difference in the Least Squares Means|-2.78|||<|0.001|TWO_SIDED|95.0|-3.45|-2.1|||cLDA|The model had fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment.||||-2.10|-3.45|<0.001
72417519|NCT01986881|144345487|SUPERIORITY||Difference in the Least Squares Means|-2.53|||<|0.001|TWO_SIDED|95.0|-3.21|-1.86|||cLDA|The model had fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment.||||-1.86|-3.21|<0.001
72417520|NCT01986881|144345488|SUPERIORITY||Difference in the Least Squares Mean|-3.15|||<|0.001|TWO_SIDED|95.0|-3.85|-2.45|||cLDA|The model had fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment.||||-2.45|-3.85|<0.001
72417521|NCT01986881|144345488|SUPERIORITY||Difference in the Least Squares Means|-2.58|||<|0.001|TWO_SIDED|95.0|-3.28|-1.89|||cLDA|The model had fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment.||||-1.89|-3.28|<0.001
72417522|NCT01986881|144345489|SUPERIORITY||Difference in the Least Squares Means|-2.72|||<|0.001|TWO_SIDED|95.0|-3.57|-1.86|||cLDA|The model had fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment.||||-1.86|-3.57|<0.001
72417523|NCT01986881|144345489|SUPERIORITY||Difference in the Least Squares Means|-2.7|||<|0.001|TWO_SIDED|95.0|-3.56|-1.85|||cLDA|The model had fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment.||||-1.85|-3.56|<0.001
72417524|NCT01986881|144345491|SUPERIORITY||Difference in the Least Squares Means|-2.6|||<|0.001|TWO_SIDED|95.0|-3.68|-1.52|||cLDA|The model had fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment.||||-1.52|-3.68|<0.001
72417525|NCT01986881|144345491|SUPERIORITY||Difference in the Least Squares Means|-2.79|||<|0.001|TWO_SIDED|95.0|-3.87|-1.71|||cLDA|The model had fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment.||||-1.71|-3.87|<0.001
72417526|NCT01986881|144345494|SUPERIORITY||Difference in the Least Squares Means|-0.96|||<|0.001|TWO_SIDED|95.0|-1.37|-0.56|||cLDA|cLDA model with fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment.||||-0.56|-1.37|<0.001
72417527|NCT01986881|144345494|SUPERIORITY||Difference in the Least Means Squares|-0.87|||<|0.001|TWO_SIDED|95.0|-1.28|-0.47|||cLDA|cLDA model with fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment.||||-0.47|-1.28|<0.001
72417528|NCT01986881|144345495|SUPERIORITY||Difference in the Least Squares Means|-0.81|||<|0.001|TWO_SIDED|95.0|-1.22|-0.39|||cLDA|The model had fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment.||||-0.39|-1.22|<0.001
72417529|NCT01986881|144345495|SUPERIORITY||Difference in the Least Squares Means|-0.83|||<|0.001|TWO_SIDED|95.0|-1.24|-0.41|||cLDA|The model had fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment.||||-0.41|-1.24|<0.001
72417530|NCT01986881|144345496|SUPERIORITY||Difference in the Least Squares Means|-0.67||||0.01|TWO_SIDED|95.0|-1.19|-0.16|||cLDA|The model had fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment.||||-0.16|-1.19|0.010
72417531|NCT01986881|144345496|SUPERIORITY||Difference in the Least Squares Means|-0.71||||0.006|TWO_SIDED|95.0|-1.22|-0.2|||cLDA|The model had fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment.||||-0.20|-1.22|0.006
72417532|NCT01986881|144345498|SUPERIORITY||Difference in the least squares means|-0.78||||0.024|TWO_SIDED|95.0|-1.46|-0.1||cLDA model with fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.|Constrained longitudinal data analysis|||||-0.10|-1.46|0.024
72417533|NCT01986881|144345498|SUPERIORITY||Difference in the least squares means|-0.81||||0.02|TWO_SIDED|95.0|-1.48|-0.13||cLDA model with fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.|Constrained longitudinal data analysis|||||-0.13|-1.48|0.020
72417534|NCT01986881|144345501|SUPERIORITY||Difference in the Least Squares Means|-1.92|||<|0.001|TWO_SIDED|95.0|-2.07|-1.77|||cLDA|cLDA model with fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment.||||-1.77|-2.07|<0.001
72417535|NCT01986881|144345501|SUPERIORITY||Difference in the Least Squares Means|-1.63|||<|0.001|TWO_SIDED|95.0|-1.78|-1.47|||cLDA|cLDA model with fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment.||||-1.47|-1.78|<0.001
72417536|NCT01986881|144345502|SUPERIORITY||Difference in the Least Squares Means|-2.45|||<|0.001|TWO_SIDED|95.0|-2.67|-2.24|||cLDA|cLDA model with fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment.||||-2.24|-2.67|<0.001
72417537|NCT01986881|144345502|SUPERIORITY||Difference in the Least Squares Means|-2.07|||<|0.001|TWO_SIDED|95.0|-2.28|-1.86|||cLDA|cLDA model with fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment.||||-1.86|-2.28|<0.001
72417538|NCT01986881|144345503|SUPERIORITY||Difference in the Least Squares Means|-2.53|||<|0.001|TWO_SIDED|95.0|-2.83|-2.22|||cLDA|cLDA model with fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment.||||-2.22|-2.83|<0.001
72417539|NCT01986881|144345503|SUPERIORITY||Difference in the Least Squares Means|-2.11|||<|0.001|TWO_SIDED|95.0|-2.39|-1.83|||cLDA|cLDA model with fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment.||||-1.83|-2.39|<0.001
72417540|NCT01986881|144345505|SUPERIORITY||Difference in the Least Squares Means|-2.53|||<|0.001|TWO_SIDED|95.0|-2.97|-2.1|||cLDA|cLDA model with fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment.||||-2.10|-2.97|<0.001
72417541|NCT01986881|144345505|SUPERIORITY||Difference in the Least Squares Means|-2.1|||<|0.001|TWO_SIDED|95.0|-2.52|-1.68|||cLDA|cLDA model with fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment.||||-1.68|-2.52|<0.001
72417542|NCT01986881|144345508|SUPERIORITY||Difference in the Lease Squares Means|-1.78|||||TWO_SIDED|95.0|-2.41|-1.15|||||||Based on cLDA model with fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.|-1.15|-2.41|
72417543|NCT01986881|144345508|SUPERIORITY||Difference in the Least Squares Means|-1.19|||||TWO_SIDED|95.0|-1.82|-0.56|||||||Based on cLDA model with fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.|-0.56|-1.82|
72417544|NCT01986881|144345509|SUPERIORITY||Difference in the Lease Squares Means|-0.88|||||TWO_SIDED|95.0|-1.58|-0.18|||||||Based on cLDA model with fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.|-0.18|-1.58|
72417545|NCT01986881|144345509|SUPERIORITY||Difference in the Least Squares Means|-0.21|||||TWO_SIDED|95.0|-0.91|0.49|||||||Based on cLDA model with fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.|0.49|-0.91|
72417546|NCT01986881|144345510|SUPERIORITY||Difference in the least squares means|0.25|||||TWO_SIDED|95.0|-0.59|1.08|||||Constrained longitudinal data analysis (cLDA) model with fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.|||1.08|-0.59|
72417547|NCT01986881|144345510|SUPERIORITY||Difference in the least squares means|1.12|||||TWO_SIDED|95.0|0.28|1.95|||||Constrained longitudinal data analysis (cLDA) model with fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.|||1.95|0.28|
72417548|NCT01986881|144345512|SUPERIORITY||Difference in the Lease Squares Means|1.48|||||TWO_SIDED|95.0|0.31|2.66|||||||Based on cLDA model with fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.|2.66|0.31|
72417549|NCT01986881|144345512|SUPERIORITY||Difference in the Least Squares Means|1.66|||||TWO_SIDED|95.0|0.49|2.84|||||||Based on cLDA model with fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.|2.84|0.49|
72417550|NCT01986881|144345536|SUPERIORITY||Difference in % vs Placebo|-0.9|||||TWO_SIDED|95.0|-2.8|0.9|||||||Miettinen \& Nurminen method|0.9|-2.8|
72417551|NCT01986881|144345536|SUPERIORITY||Difference in % vs Placebo|0.3|||||TWO_SIDED|95.0|-1.6|2.1|||||||Miettinen \& Nurminen method|2.1|-1.6|
72417552|NCT01986881|144345537|SUPERIORITY||Difference in % vs Placebo|1.3|||||TWO_SIDED|95.0|-5.8|8.4|||||||Miettinen \& Nurminen method|8.4|-5.8|
72417553|NCT01986881|144345537|SUPERIORITY||Difference in % vs Placebo|-1.9|||||TWO_SIDED|95.0|-9.2|5.4|||||||Miettinen \& Nurminen method|5.4|-9.2|
72417554|NCT01986881|144345538|SUPERIORITY||Difference in % vs Placebo|1.4|||||TWO_SIDED|95.0|-17.7|20.4|||||||Miettinen and Nurminen method|20.4|-17.7|
72608928|NCT02557399|144746632|SUPERIORITY_OR_OTHER||Difference in percentage|-0.5||||0.81|TWO_SIDED|95.0|-8.8|7.7||The P-value was based on the Cochran-Mantel-Haenszel test stratified by center.|Cochran-Mantel-Haenszel||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 8 for TLs. The participants with missing data at a visit were included in the denominator (n) at the visit. That is, those participants were treated as non-responder at the visit.|||7.7|-8.8|0.810
72608929|NCT02557399|144746632|SUPERIORITY_OR_OTHER||Difference in percentage|1.9||||0.648|TWO_SIDED|95.0|-5.2|9.0||The P-value was based on the Cochran-Mantel-Haenszel test stratified by center.|Cochran-Mantel-Haenszel||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 12 for TLs. The participants with missing data at a visit were included in the denominator (n) at the visit. That is, those participants were treated as non-responder at the visit.|||9.0|-5.2|0.648
72608930|NCT02557399|144746632|SUPERIORITY_OR_OTHER||Difference in percentage|9.1||||0.048|TWO_SIDED|95.0|-1.3|19.6||The P-value was based on the Cochran-Mantel-Haenszel test stratified by center.|Cochran-Mantel-Haenszel||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 1 for ILs. The participants with missing data at a visit were included in the denominator (n) at the visit. That is, those participants were treated as non-responder at the visit.|||19.6|-1.3|0.048
72608931|NCT02557399|144746632|SUPERIORITY_OR_OTHER||Difference in percentage|11.2||||0.016|TWO_SIDED|95.0|1.8|20.6||The P-value was based on the Cochran-Mantel-Haenszel test stratified by center.|Cochran-Mantel-Haenszel||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 2 for ILs. The participants with missing data at a visit were included in the denominator (n) at the visit. That is, those participants were treated as non-responder at the visit.|||20.6|1.8|0.016
72608932|NCT02557399|144746632|SUPERIORITY_OR_OTHER||Difference in percentage|8.6||||0.044|TWO_SIDED|95.0|0.4|16.9||The P-value was based on the Cochran-Mantel-Haenszel test stratified by center.|Cochran-Mantel-Haenszel||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 4 for ILs. The participants with missing data at a visit were included in the denominator (n) at the visit. That is, those participants were treated as non-responder at the visit.|||16.9|0.4|0.044
72608933|NCT02557399|144746632|SUPERIORITY_OR_OTHER||Difference in percentage|3.6||||0.345|TWO_SIDED|95.0|-3.8|11.0||The P-value was based on the Cochran-Mantel-Haenszel test stratified by center.|Cochran-Mantel-Haenszel||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 8 for ILs. The participants with missing data at a visit were included in the denominator (n) at the visit. That is, those participants were treated as non-responder at the visit.|||11.0|-3.8|0.345
72608934|NCT02557399|144746632|SUPERIORITY_OR_OTHER||Difference in percentage|2.6||||0.424|TWO_SIDED|95.0|-3.5|8.7||The P-value was based on the Cochran-Mantel-Haenszel test stratified by center.|Cochran-Mantel-Haenszel||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 12 for ILs. The participants with missing data at a visit were included in the denominator (n) at the visit. That is, those participants were treated as non-responder at the visit.|||8.7|-3.5|0.424
72608935|NCT02557399|144746632|SUPERIORITY_OR_OTHER||Difference in percentage|-2.0||||0.527|TWO_SIDED|95.0|-9.4|5.5||The P-value was based on the Cochran-Mantel-Haenszel test stratified by center.|Cochran-Mantel-Haenszel||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 1 for non-ILs. The participants with missing data at a visit were included in the denominator (n) at the visit. That is, those participants were treated as non-responder at the visit.|||5.5|-9.4|0.527
72608936|NCT02557399|144746632|SUPERIORITY_OR_OTHER||Difference in percentage|3.3||||0.584|TWO_SIDED|95.0|-6.7|13.4||The P-value was based on the Cochran-Mantel-Haenszel test stratified by center.|Cochran-Mantel-Haenszel||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 2 for non-ILs. The participants with missing data at a visit were included in the denominator (n) at the visit. That is, those participants were treated as non-responder at the visit.|||13.4|-6.7|0.584
72608937|NCT02557399|144746632|SUPERIORITY_OR_OTHER||Difference in percentage|3.9||||0.519|TWO_SIDED|95.0|-6.5|14.3||The P-value was based on the Cochran-Mantel-Haenszel test stratified by center.|Cochran-Mantel-Haenszel||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 4 for non-ILs. The participants with missing data at a visit were included in the denominator (n) at the visit. That is, those participants were treated as non-responder at the visit.|||14.3|-6.5|0.519
72608938|NCT02557399|144746632|SUPERIORITY_OR_OTHER||Difference in percentage|-0.8||||0.766|TWO_SIDED|95.0|-10.1|8.5||The P-values are based on the Cochran-Mantel-Haenszel test stratified by center.|Cochran-Mantel-Haenszel||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 8 for non-ILs. The participants with missing data at a visit were included in the denominator (n) at the visit. That is, those participants were treated as non-responder at the visit.|||8.5|-10.1|0.766
72608939|NCT02557399|144746632|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.3||||0.666|TWO_SIDED|95.0|-5.8|10.5||The P-value was based on the Cochran-Mantel-Haenszel test stratified by center.|Cochran-Mantel-Haenszel||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 12 for non-ILs. The participants with missing data at a visit were included in the denominator (n) at the visit. That is, those participants were treated as non-responder at the visit.|||10.5|-5.8|0.666
72608940|NCT02557399|144746636|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.22||||0.017|TWO_SIDED|95.0|-0.4|-0.04|||mixed model repeated measures analysis||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 2. A negative treatment difference indicates a benefit of Duac relative to ADA+CLDM.|||-0.04|-0.40|0.017
72608941|NCT02557399|144746636|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.22||||0.017|TWO_SIDED|95.0|-0.4|-0.04|||mixed model repeated measures analysis||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 4. A negative treatment difference indicates a benefit of Duac relative to ADA+CLDM.|||-0.04|-0.40|0.017
72417555|NCT01986881|144345538|SUPERIORITY||Difference in % vs Placebo|-19.9|||||TWO_SIDED|95.0|-37.5|-1.2|||||||Miettinen and Nurminen method|-1.2|-37.5|
72417556|NCT01986881|144345539|SUPERIORITY||Difference in % vs Placebo|7.9|||||TWO_SIDED|95.0|-5.1|20.5|||||||Based on Miettinen and Nurminen method|20.5|-5.1|
72417557|NCT01986881|144345539|SUPERIORITY||Difference in % vs Placebo|1.0|||||TWO_SIDED|95.0|-12.3|14.2|||||||Miettinen and Nurminen method|14.2|-12.3|
72417558|NCT01986881|144345541|SUPERIORITY||Difference in % vs Placebo|0.0|||||TWO_SIDED|95.0|-2.9|3.0|||||||Miettinen \& Nurminen method|3.0|-2.9|
72417559|NCT01986881|144345541|SUPERIORITY||Difference in % vs Placebo|-1.2|||||TWO_SIDED|95.0|-4.0|1.6|||||||Miettinen \& Nurminen method|1.6|-4.0|
72417560|NCT01986881|144345544|SUPERIORITY||Difference in the Least Squares Means|-25.4|||<|0.001|TWO_SIDED|95.0|-32.84|-17.96|||CLDA|Model with fixed effects for treatment, time, baseline eGFR, stratum (insulin alone or insulin + metformin) and the interaction of time by treatment.||||-17.96|-32.84|<0.001
72417561|NCT01986881|144345544|SUPERIORITY||Difference in the Least Squares Means|-19.24|||<|0.001|TWO_SIDED|95.0|-26.8|-11.68|||cLDA|Model with fixed effects for treatment, time, baseline eGFR, stratum (insulin alone or insulin + metformin) and the interaction of time by treatment.||||-11.68|-26.80|<0.001
72417562|NCT01986881|144345545|SUPERIORITY||Difference in the Least Squares Means|-1.88|||<|0.001|TWO_SIDED|95.0|-2.37|-1.13|||cLDA|Model with fixed effects for treatment, time, baseline eGFR, stratum (insulin alone or insulin + metformin) and the interaction of time by treatment.||||-1.13|-2.37|<0.001
72417563|NCT01986881|144345545|SUPERIORITY||Difference in the Least Squares Means|-1.62|||<|0.001|TWO_SIDED|95.0|-2.12|-1.13|||cLDA model|Model with fixed effects for treatment, time, baseline eGFR, stratum (insulin alone or insulin + metformin) and the interaction of time by treatment.||||-1.13|-2.12|<0.001
72417564|NCT01986881|144345546|SUPERIORITY||Adjusted Odds Ratio Relative to Placebo|2.49|||<|0.001|TWO_SIDED|95.0|1.61|3.83|||Regression, Logistic|Model fitted with fixed effects for treatment, stratum for insulin sub-study, covariates for baseline A1C and baseline eGFR (continuous).||Missing data imputed using the Constrained Longitudinal Data Analysis (cLDA) model fitted with fixed effects as in the primary analysis.||3.83|1.61|<0.001
72417565|NCT01986881|144345546|SUPERIORITY||Adjusted Odds Ratio Relative to Placebo|2.6|||<|0.001|TWO_SIDED|95.0|1.64|4.12|||Regression, Logistic|Model fitted with fixed effects for treatment, stratum for insulin sub-study, covariates for baseline A1C and baseline eGFR (continuous).||Missing data imputed using the Constrained Longitudinal Data Analysis (cLDA) model fitted with fixed effects as in the primary analysis.||4.12|1.64|<0.001
72417566|NCT01986881|144345547|SUPERIORITY||Difference in the Least Squares Means|-2.32||||0.025|TWO_SIDED|95.0|-4.35|-0.3|||cLDA|Model with fixed effects for treatment, time, baseline eGFR, stratum (insulin alone or insulin + metformin), and the interaction of time by treatment.||||-0.30|-4.35|0.025
72325585|NCT02525679|144174725|SUPERIORITY_OR_OTHER_LEGACY||Slope|1.5968|STANDARD_ERROR_OF_MEAN|0.1047|||TWO_SIDED|95.0|1.3784|1.8151|||||Based on the estimate for the slope parameter, a two sided 95% confidence interval for the slope was computed. Perfect dose proportionality would correspond to a slope of 1. Standard error (SE) of the mean is actually SE of the slope.|Dose proportionality in plasma for Cmax (log-transformed scale) was explored based on the linear regression model.||1.8151|1.3784|
72417567|NCT01986881|144345547|SUPERIORITY||Difference in the Least Squares Means|-2.88||||0.006|TWO_SIDED|95.0|-4.94|-0.82|||cLDA|Model with fixed effects for treatment, time, baseline eGFR, stratum (insulin alone or insulin + metformin), and the interaction of time by treatment.||||-0.82|-4.94|0.006
72417568|NCT01986881|144345548|SUPERIORITY||Difference in the Least Squares Means|-0.38||||0.533|TWO_SIDED|95.0|-1.56|0.81|||cLDA model|Model with fixed effects for treatment, time, baseline eGFR, stratum (insulin alone or insulin + metformin), and the interaction of time by treatment.||||0.81|-1.56|0.533
72417569|NCT01986881|144345548|SUPERIORITY||Difference in the Least Squares Means|-0.6||||0.326|TWO_SIDED|95.0|-1.81|0.6|||cLDA model|Model with fixed effects for treatment, time, baseline eGFR, stratum (insulin alone or insulin + metformin), and the interaction of time by treatment.||||0.60|-1.81|0.326
72417570|NCT01986881|144345551|SUPERIORITY||Difference in the Least Squares Means|-12.22||||0.105|TWO_SIDED|95.0|-27.03|2.06|||cLDA|cLDA model with fixed effects for treatment, time, baseline eGFR (continuous), and the interaction of time by treatment.||||2.06|-27.03|0.105
72417571|NCT01986881|144345551|SUPERIORITY||Difference in the Least Squares Means|-13.53||||0.068|TWO_SIDED|95.0|-28.06|1.0|||cLDA|cLDA model with fixed effects for treatment, time, baseline eGFR (continuous), and the interaction of time by treatment.||||1.00|-28.06|0.068
72608942|NCT02557399|144746636|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.22||||0.024|TWO_SIDED|95.0|-0.41|-0.03|||mixed model repeated measures analysis||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 8. A negative treatment difference indicates a benefit of Duac relative to ADA+CLDM.|||-0.03|-0.41|0.024
72608943|NCT02557399|144746636|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.17||||0.08|TWO_SIDED|95.0|-0.36|0.02|||mixed model repeated measures analysis||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 12. A negative treatment difference indicates a benefit of Duac relative to ADA+CLDM.|||0.02|-0.36|0.080
72608944|NCT02848664|144746640|OTHER|Same DOSS score before and after device use for 3 months or improved DOSS score after device use for 3 months|||||<|0.025||||||p values adjusted for multiple comparisons (two outcome measures)|Wilcoxon (Mann-Whitney)|||Examined change in DOSS for each participant from before to after three months of device use. Examined numbers of participants who showed either worsening of DOSS, no improvement in DOSS or improvement of DOSS.||||<0.025
72608945|NCT02848664|144746641|EQUIVALENCE|Examination of whether the level of swallowing handicap is changed following device use|Mean Difference (Net)|22.571||||0.016|TWO_SIDED|95.0|6.003|39.14|||t-test, 2 sided|||||39.140|6.003|0.016
72608946|NCT02848664|144746642|EQUIVALENCE|whether the degree of laryngeal elevation relative to hyoid elevation became greater or less after device use for 3 months||||||0.046|||||||t-test, 2 sided|||||||0.046
72608947|NCT02848664|144746643|EQUIVALENCE|pairwise comparison within subject comparing baseline with 3 months post device use|Mean Difference (Final Values)|-52.78||||0.037|TWO_SIDED|95.0|-100.751|-4.809|||ANOVA|||||-4.809|-100.751|0.037
72608948|NCT00402727|144746644|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin was set to 10% in the protocol, in agreeance with FDA recommendations. Sample size was estimated using the method as described in Farrington-Manning. Estimation was performed to achieve 85% power, based on the equivalence delta of 10%, and a clinical success rate of 80% in the per protocol population|Difference of cure rates (in percent)|-1.0||||||95.0|-5.3|3.9|||||A positive value indicates an advantage for the treatment group of moxifloxacin, a negative value an advantage for the comparator group.|Calculated were 95% confidence intervals for the difference in success rates between treatment groups (moxifloxacin minus comparator). Method as described in Koch et al.||3.9|-5.3|
72608949|NCT00402727|144746645|NON_INFERIORITY_OR_EQUIVALENCE|Sample size estimation was based on the primary efficacy variable.|Difference of cure rates (in percent)|1.3||||||95.0|-3.8|6.3|||||A positive value indicates an advantage for the treatment group of moxifloxacin, a negative value an advantage for the comparator group|Calculated were 95% confidence intervals for the difference in success rates between treatment groups (moxifloxacin minus comparator). Method as described in Koch et al.||6.3|-3.8|
72608950|NCT00402727|144746646|NON_INFERIORITY_OR_EQUIVALENCE|Sample size estimation was based on the primary efficacy variable.|Difference of improvement rates (in %)|-0.7||||||95.0|-1.6|0.6|||||A positive value indicates an advantage for the treatment group of moxifloxacin, a negative value an advantage for the comparator group|Calculated were 95% confidence intervals for the difference in success rates between treatment groups (moxifloxacin minus comparator). Method as described in Koch et al.||0.6|-1.6|
72608951|NCT00402727|144746647|NON_INFERIORITY_OR_EQUIVALENCE|Sample size estimation was based on the primary efficacy variable.|Difference of improvement rates (in %)|1.4||||||95.0|-1.3|3.9|||||A positive value indicates an advantage for the treatment group of moxifloxacin, a negative value an advantage for the comparator group|Calculated were 95% confidence intervals for the difference in success rates between treatment groups (moxifloxacin minus comparator). Method as described in Koch et al.||3.9|-1.3|
72608952|NCT00402727|144746648|NON_INFERIORITY_OR_EQUIVALENCE|Sample size estimation was based on the primary efficacy variable.|Difference of resolution rates (in %)|0.2||||||95.0|-3.1|2.4|||||A positive value indicates an advantage for the treatment group of moxifloxacin, a negative value an advantage for the comparator group|Calculated were 95% confidence intervals for the difference in success rates between treatment groups (moxifloxacin minus comparator). Method as described in Koch et al.||2.4|-3.1|
72608953|NCT00402727|144746649|NON_INFERIORITY_OR_EQUIVALENCE|Sample size estimation was based on the primary efficacy variable.|Difference of resolution rates (in %)|1.6||||||95.0|-2.4|5.3|||||A positive value indicates an advantage for the treatment group of moxifloxacin, a negative value an advantage for the comparator group|Calculated were 95% confidence intervals for the difference in success rates between treatment groups (moxifloxacin minus comparator). Method as described in Koch et al.||5.3|-2.4|
72608954|NCT00402727|144746650|NON_INFERIORITY_OR_EQUIVALENCE|Sample size estimation was based on the primary efficacy variable.|Difference of eradication rates (in %)|-8.5||||||95.0|-17.0|-1.4|||||A positive value indicates an advantage for the treatment group of moxifloxacin, a negative value an advantage for the comparator group|Calculated were 95% confidence intervals for the difference in success rates between treatment groups (moxifloxacin minus comparator). Method as described in Koch et al.||-1.4|-17.0|
72608955|NCT00402727|144746651|NON_INFERIORITY_OR_EQUIVALENCE|Sample size estimation was based on the primary efficacy variable.|Difference of eradication rates (in %)|-8.6||||||95.0|-17.6|-0.4|||||A positive value indicates an advantage for the treatment group of moxifloxacin, a negative value an advantage for the comparator group|Calculated were 95% confidence intervals for the difference in success rates between treatment groups (moxifloxacin minus comparator). Method as described in Koch et al.||-0.4|-17.6|
72417572|NCT01986881|144345552|SUPERIORITY||Difference in the Least Squares Means|-0.52||||0.418|TWO_SIDED|95.0|-1.79|0.75|||cLDA|Model with fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment.||||0.75|-1.79|0.418
72417573|NCT01986881|144345552|SUPERIORITY||Difference in the Least Squares Means|-1.07||||0.092|TWO_SIDED|95.0|-2.32|0.18|||cLDA model|Model with fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment.||||0.18|-2.32|0.092
72417574|NCT01986881|144345553|SUPERIORITY||Odds ratio relative to placebo|1.48||||0.46|TWO_SIDED|95.0|0.52|4.17|||Regression, Logistic|Model fitted with fixed effects for treatment, covariates for baseline A1C and baseline eGFR (continuous).||Missing data imputed using the Constrained Longitudinal Data Analysis (cLDA) model fitted with fixed effects as in the primary analysis.||4.17|0.52|0.460
72417575|NCT01986881|144345553|SUPERIORITY||Odds ratio relative to placebo|1.62||||0.335|TWO_SIDED|95.0|0.61|4.35|||Regression, Logistic|Model fitted with fixed effects for treatment, covariates for baseline A1C and baseline eGFR (continuous).||Missing data imputed using the Constrained Longitudinal Data Analysis (cLDA) model fitted with fixed effects as in the primary analysis.||4.35|0.61|0.335
72417576|NCT01986881|144345554|SUPERIORITY||Difference in the Least Squares Means|2.73||||0.255|TWO_SIDED|95.0|-2.0|7.45|||cLDA|The model had fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment.||||7.45|-2.00|0.255
72417577|NCT01986881|144345554|SUPERIORITY||Difference in the Least Squares Means|2.81||||0.235|TWO_SIDED|95.0|-1.85|7.48|||cLDA|The model had fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment.||||7.48|-1.85|0.235
72417578|NCT01986881|144345555|SUPERIORITY||Difference in the Least Squares Means|1.98||||0.178|TWO_SIDED|95.0|-0.91|4.86|||cLDA model|Model with fixed effects for treatment, time, baseline eGFR, stratum (insulin alone or insulin + metformin), and the interaction of time by treatment.||||4.86|-0.91|0.178
72417579|NCT01986881|144345555|SUPERIORITY||Difference in the Least Squares Means|1.73||||0.23|TWO_SIDED|95.0|-1.11|4.58|||cLDA|Model with fixed effects for treatment, time, baseline eGFR, stratum (insulin alone or insulin + metformin), and the interaction of time by treatment.||||4.58|-1.11|0.230
72417580|NCT01986881|144345556|SUPERIORITY||Difference in the Least Squares Means|-31.37|||<|0.001|TWO_SIDED|95.0|-40.68|-22.07|||CLDA|cLDA model with fixed effects for treatment, time, baseline eGFR (continuous), and the interaction of time by treatment.||||-22.07|-40.68|<0.001
72608956|NCT00402727|144746652|NON_INFERIORITY_OR_EQUIVALENCE|Sample size estimation was based on the primary efficacy variable.|Difference of eradication rates (in %)|-3.9||||||95.0|-9.5|1.4|||||A positive value indicates an advantage for the treatment group of moxifloxacin, a negative value an advantage for the comparator group|Calculated were 95% confidence intervals for the difference in success rates between treatment groups (moxifloxacin minus comparator). Method as described in Koch et al.||1.4|-9.5|
72417581|NCT01986881|144345556|SUPERIORITY||Difference in the Least Squares Means|-30.47|||<|0.001|TWO_SIDED|95.0|-40.23|-20.72|||cLDA|cLDA model with fixed effects for treatment, time, baseline eGFR (continuous), and the interaction of time by treatment.||||-20.72|-40.23|<0.001
72417582|NCT01986881|144345557|SUPERIORITY||Difference in the Least Squares Means|-1.94|||<|0.001|TWO_SIDED|95.0|-2.65|-1.24|||cLDA|Model with fixed effects for treatment, time, baseline eGFR (continuous), and the interaction of time by treatment.||||-1.24|-2.65|<0.001
72417583|NCT01986881|144345557|SUPERIORITY||Difference in the Least Squares Means|-1.57|||<|0.001|TWO_SIDED|95.0|-2.3|-0.84|||cLDA|Model with fixed effects for treatment, time, baseline eGFR (continuous), and the interaction of time by treatment.||||-0.84|-2.30|<0.001
72417584|NCT01986881|144345558|SUPERIORITY||Adjusted odds ratio relative to placebo|4.1|||<|0.001|TWO_SIDED|95.0|2.0|8.42|||Regression, Logistic|Model fitted with fixed effects for treatment, covariates for baseline A1C and baseline eGFR (continuous).||Missing data imputed using the cLDA model fitted with fixed effects as in the primary analysis.||8.42|2.00|<0.001
72417585|NCT01986881|144345558|SUPERIORITY||Adjusted odds ratio relative to placebo|5.97|||<|0.001|TWO_SIDED|95.0|2.86|12.49|||Regression, Logistic|Model fitted with fixed effects for treatment, covariates for baseline A1C and baseline eGFR (continuous).||Missing data imputed using the cLDA model fitted with fixed effects as in the primary analysis.||12.49|2.86|<0.001
72417586|NCT01986881|144345559|SUPERIORITY||Difference in the Least Squares Means|-0.85||||0.597|TWO_SIDED|95.0|-4.0|2.3|||cLDA|The model had fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment.||||2.30|-4.00|0.597
72417587|NCT01986881|144345559|SUPERIORITY||Difference in the Least Squares Means|-1.57||||0.351|TWO_SIDED|95.0|-4.87|1.73|||cLDA|The model had fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment.||||1.73|-4.87|0.351
72417588|NCT01986881|144345560|SUPERIORITY||Difference in the Least Squares Means|-0.68||||0.49|TWO_SIDED|95.0|-2.6|1.25|||cLDA|Model with fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment.||||1.25|-2.60|0.490
72417589|NCT01986881|144345560|SUPERIORITY||Difference in the Least Squares Means|-0.05||||0.958|TWO_SIDED|95.0|-2.07|1.96|||cLDA|Model with fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment.||||1.96|-2.07|0.958
72417590|NCT05183022|144345561|SUPERIORITY|||||||0.07|||||||ANOVA|||||||0.07
72417591|NCT04149925|144345595|SUPERIORITY|||||||0.01||||||Significant when p\<0.05|t-test, 2 sided|||||||0.01
72417592|NCT02586025|144345601|SUPERIORITY||Difference in response rates|17.45||||0.0014|TWO_SIDED|95.0|6.89|28.01||Two-sided significance level of 5%|Cochran-Mantel-Haenszel|Stratified by disease category (early-stage and locally advanced) and hormone-receptor status (positive for ER and/or PgR or negative for both)|Pertuzumab, Trastuzumab, Docetaxel arm minus Placebo, Trastuzumab, Docetaxel arm. Approximate 95% CI for difference of two rates using Hauck-Anderson method.|||28.01|6.89|0.0014
72417593|NCT02586025|144345602|SUPERIORITY||Difference in response rates|18.36||||0.0008|TWO_SIDED|95.0|7.89|28.83||Two-sided significance level of 5%|Cochran-Mantel-Haenszel|Stratified by disease category (early-stage and locally advanced) and hormone-receptor status (positive for ER and/or PgR or negative for both)|Pertuzumab, Trastuzumab, Docetaxel arm minus Placebo, Trastuzumab, Docetaxel arm. Approximate 95% CI for difference of two rates using Hauck-Anderson method.|||28.83|7.89|0.0008
72417594|NCT02586025|144345603|SUPERIORITY||Difference in response rates|18.37||||0.001|TWO_SIDED|95.0|7.6|29.15||Two-sided significance level of 5%|Cochran-Mantel-Haenszel|Stratified by disease category (early-stage and locally advanced) and hormone-receptor status (positive for ER and/or PgR or negative for both)|Pertuzumab, Trastuzumab, Docetaxel arm minus Placebo, Trastuzumab, Docetaxel arm. Approximate 95% CI for difference of two rates using Hauck-Anderson method.|||29.15|7.60|0.0010
72417595|NCT02586025|144345604|SUPERIORITY||Difference in response rates|18.83||||0.0006|TWO_SIDED|95.0|8.14|29.51||Two-sided significance level of 5%|Cochran-Mantel-Haenszel|Stratified by disease category (early-stage and locally advanced) and hormone-receptor status (positive for ER and/or PgR or negative for both)|Pertuzumab, Trastuzumab, Docetaxel arm minus Placebo, Trastuzumab, Docetaxel arm. Approximate 95% CI for difference of two rates using Hauck-Anderson method.|||29.51|8.14|0.0006
72417596|NCT02586025|144345606|SUPERIORITY||Difference in response rates|10.4||||0.0125|TWO_SIDED|95.0|1.12|19.69||Two-sided significance level of 5%|Cochran-Mantel-Haenszel|Stratified by disease category (early-stage and locally advanced) and hormone-receptor status (positive for ER and/or PgR or negative for both)|Pertuzumab, Trastuzumab, Docetaxel arm minus Placebo, Trastuzumab, Docetaxel arm|||19.69|1.12|0.0125
72417597|NCT02586025|144345607|SUPERIORITY||Hazard Ratio (HR)|0.53||||0.014|TWO_SIDED|95.0|0.32|0.89|||Stratified log-rank|Two-sided log-rank test used, stratified by disease category (early-stage/locally advanced) \& hormone-receptor status (ER+ \&/or PgR+ or ER- \& PgR-)|The hazard ratio was calculated by stratified Cox proportional hazards model.|Hazard Ratio for EFS Event in the Pertuzumab arm vs. Placebo arm||0.89|0.32|0.0140
72417598|NCT02586025|144345607|SUPERIORITY||Difference in EFS Event-Free Rates|-8.16||||0.0062|TWO_SIDED|95.0|-14.0|-2.32|||Z-test||The difference in EFS event-free rates was calculated as the Placebo arm minus the Pertuzumab arm.|Difference in EFS Event-Free Rates at 1 year||-2.32|-14.00|0.0062
72417599|NCT02586025|144345607|SUPERIORITY||Difference in EFS Event-Free Rates|-9.17||||0.0429|TWO_SIDED|95.0|-18.05|-0.29|||Z-test||The difference in EFS event-free rates was calculated as the Placebo arm minus the Pertuzumab arm.|Difference in EFS Event-Free Rates at 3 years||-0.29|-18.05|0.0429
72417600|NCT02586025|144345607|SUPERIORITY||Difference in EFS Event-Free Rates|-11.1||||0.0274|TWO_SIDED|95.0|-20.95|-1.24|||Z-test||The difference in EFS event-free rates was calculated as the Placebo arm minus the Pertuzumab arm.|Difference in EFS Event-Free Rates at 5 Years||-1.24|-20.95|0.0274
72417601|NCT02586025|144345608|SUPERIORITY||Hazard Ratio (HR)|0.52||||0.014|TWO_SIDED|95.0|0.3|0.88|||Stratified log-rank|Two-sided log-rank test used, stratified by disease category (early-stage/locally advanced) \& hormone-receptor status (ER+ \&/or PgR+ or ER- \& PgR-)|The hazard ratio was calculated by stratified Cox proportional hazards model.|Hazard Ratio for DFS Event in the Pertuzumab arm vs. Placebo arm||0.88|0.30|0.0140
72417602|NCT02586025|144345608|SUPERIORITY||Difference in DFS Event-Free Rates|-5.47||||0.0592|TWO_SIDED|95.0|-11.15|0.21|||Z-test||The difference in DFS event-free rates was calculated as the Placebo arm minus the Pertuzumab arm.|Difference in DFS Event-Free Rates at 1 year||0.21|-11.15|0.0592
72417603|NCT02586025|144345608|SUPERIORITY||Difference in DFS Event-Free Rates|-9.0||||0.0426|TWO_SIDED|95.0|-17.69|-0.3|||Z-test||The difference in DFS event-free rates was calculated as the Placebo arm minus the Pertuzumab arm.|Difference in DFS Event-Free Rates at 3 years||-0.30|-17.69|0.0426
72417604|NCT02586025|144345608|SUPERIORITY||Difference in DFS Event-Free Rates|-10.97||||0.0276|TWO_SIDED|95.0|-20.73|-1.21|||Z-test||The difference in DFS event-free rates was calculated as the Placebo arm minus the Pertuzumab arm.|Difference in DFS Event-Free Rates at 5 years||-1.21|-20.73|0.0276
72417605|NCT02586025|144345609|SUPERIORITY||Hazard Ratio (HR)|0.53||||0.1181|TWO_SIDED|95.0|0.23|1.19|||Stratified log-rank|Two-sided log-rank test used, stratified by disease category (early-stage/locally advanced) \& hormone-receptor status (ER+ \&/or PgR+ or ER- \& PgR-)|The hazard ratio was calculated by stratified Cox proportional hazards model.|Hazard Ratio for OS Event in the Pertuzumab arm vs. Placebo arm||1.19|0.23|0.1181
72417606|NCT02586025|144345609|SUPERIORITY||Difference in OS Event-Free Rates|0.46||||0.3162|TWO_SIDED|95.0|-0.44|1.36|||Z-test||The difference in OS event-free rates was calculated as the Placebo arm minus the Pertuzumab arm.|Difference in OS Event-Free Rates at 1 year||1.36|-0.44|0.3162
72417607|NCT02586025|144345609|SUPERIORITY||Difference in OS Event-Free Rates|-6.02||||0.0529|TWO_SIDED|95.0|-12.11|0.08|||Z-test||The difference in OS event-free rates was calculated as the Placebo arm minus the Pertuzumab arm.|Difference in OS Event-Free Rates at 3 years||0.08|-12.11|0.0529
72417608|NCT02586025|144345609|SUPERIORITY||Difference in OS Event-Free Rates|-3.89||||0.2616|TWO_SIDED|95.0|-10.69|2.9|||Z-test||The difference in OS event-free rates was calculated as the Placebo arm minus the Pertuzumab arm.|Difference in OS Event-Free Rates at 5 years||2.90|-10.69|0.2616
72417609|NCT02586025|144345615|OTHER||Mean Difference (Final Values)|-0.35|||||TWO_SIDED|95.0|-1.62|0.93|||||Pertuzumab, Trastuzumab, Docetaxel arm minus Placebo, Trastuzumab, Docetaxel arm|||0.93|-1.62|
72417610|NCT00175825|144345627|SUPERIORITY_OR_OTHER||Percent reduction over Placebo|9.8|||=|0.24|TWO_SIDED|95.0|-7.2|24.0|||ANCOVA|||ANCOVA with baseline seizure frequency per week and each of the stratification factors as independent variables.||24.0|-7.2|=0.240
72417611|NCT00175825|144345627|SUPERIORITY_OR_OTHER||Percent reduction over Placebo|14.9|||=|0.062|TWO_SIDED|95.0|-0.8|28.2|||ANCOVA|||ANCOVA with baseline seizure frequency per week and each of the stratification factors as independent variables.||28.2|-0.8|=0.062
72417612|NCT00175825|144345627|SUPERIORITY_OR_OTHER||Percent reduction over Placebo|22.1|||=|0.004|TWO_SIDED|95.0|7.6|34.3|||ANCOVA|||ANCOVA with baseline seizure frequency per week and each of the stratification factors as independent variables.||34.3|7.6|=0.004
72417613|NCT00608582|144345635|SUPERIORITY_OR_OTHER||||||<|0.028||||||p\<0.05 considered significant|ANOVA|Post-hoc paired t-tests were performed.||A repeated measures ANOVA is performed with a significance level of p\<0.05 (two-sided). Factors: Time (Baseline vs. 2 Mo. Post rTMS treatment) and Group (Real vs. Sham).||||<0.028
72417614|NCT00608582|144345635|SUPERIORITY_OR_OTHER||||||<|0.05||||||p\<.05 considered significant; Pairwise comparisons not adjusted for multiple comparisons|t-test, 2 sided|||Paired, t-tests were performed if the ANOVA yields a significant interaction (p\<0.05, two-sided) for Baseline vs. 2 months after last rTMS treatment.||||<0.05
72417615|NCT00608582|144345635|SUPERIORITY_OR_OTHER||||||<|0.237||||||p\<0.05 considered significant. Pairwise comparisons were not corrected for multiple comparisons.|t-test, 2 sided|||Paired, t-tests were performed if the ANOVA yields a significant interaction (p\<0.05, two-sided) for Baseline vs. 2 Mo. after last Sham rTMS treatment.||||<0.237
72417616|NCT00608582|144345636|SUPERIORITY_OR_OTHER|||||||0.414||||||p\<0.05 considered significant|ANOVA|||A repeated measures ANOVA is performed with a significance level of p\<0.05 (two-sided). Factors: Time (Baseline vs. 2 months after last rTMS treatment) and Group (Real vs. Sham).||||0.414
72417617|NCT00608582|144345636|SUPERIORITY_OR_OTHER||||||<|0.822||||||p\<0.05 considered significant|ANOVA|||A repeated measures ANOVA is performed with a significance level of p\<0.05 (two-sided). Factors: Time (Baseline vs. 2 months after last rTMS treatment) and Group (Real vs. Sham).||||<0.822
72417618|NCT00608582|144345636|SUPERIORITY_OR_OTHER||||||<|0.835||||||p\<0.05 considered significant|ANOVA|||A repeated measures ANOVA is performed with a significance level of p\<0.05 (two-sided). Factors: Time (Baseline vs. 2 months after last rTMS treatment) and Group (Real vs. Sham).||||<0.835
72417619|NCT04250727|144345641|SUPERIORITY|||||||0.601|||||||Wilcoxon (Mann-Whitney)|||||||0.601
72417620|NCT00160680|144345670|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.27|||=|0.667|TWO_SIDED|95.0|-0.96|1.5|||ANCOVA|||||1.50|-0.96|=0.667
72417621|NCT03595579|144345689|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<.001
72417622|NCT03595579|144345690|SUPERIORITY|||||||0.013|||||||Mixed Models Analysis|||||||0.013
72417623|NCT02450331|144345691|SUPERIORITY||Hazard Ratio (HR)|0.892||||0.2446|TWO_SIDED|95.0|0.735|1.081|||Log Rank|||||1.081|0.735|0.2446
72417624|NCT02450331|144345692|SUPERIORITY||Hazard Ratio (HR)|0.897||||0.3172|TWO_SIDED|95.0|0.726|1.109|||Log Rank|||Stratified analysis based on PDL1 status, tumor stage after resection, and nodal status.||1.109|0.726|0.3172
72417625|NCT02450331|144345693|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.836||||0.2235|TWO_SIDED|95.0|0.626|1.116|||Log Rank|||||1.116|0.626|0.2235
72608957|NCT00402727|144746653|NON_INFERIORITY_OR_EQUIVALENCE|Sample size estimation was based on the primary efficacy variable.|Difference of eradication rates (in %)|-5.6||||||95.0|-11.4|-0.8|||||A positive value indicates an advantage for the treatment group of moxifloxacin, a negative value an advantage for the comparator group|Calculated were 95% confidence intervals for the difference in success rates between treatment groups (moxifloxacin minus comparator). Method as described in Koch et al.||-0.8|-11.4|
72417626|NCT02450331|144345694|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.918||||0.4291|TWO_SIDED|95.0|0.743|1.134|||Log Rank|||||1.134|0.743|0.4291
72417627|NCT02450331|144345695|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.879||||0.1994|TWO_SIDED|95.0|0.722|1.07|||Log Rank|||||1.070|0.722|0.1994
72417628|NCT03148470|144345705|OTHER|||||||0.932||||||This p-value refers to the effect of stimulation (cTBS vs iTBS).|Mixed Models Analysis|||||||0.932
72417629|NCT03148470|144345706|OTHER|||||||0.642|||||||Mixed Models Analysis|||||||0.642
72417630|NCT03232983|144345707|SUPERIORITY||Ratio of Geometric Least Squares Means|1.03|||||TWO_SIDED|90.0|0.992|1.07|||Mixed Models Analysis|||Geometric Least Squares Means (LSMeans) were controlled for injection site, study period, and sequence as fixed effects, and subject within sequence as a random effect.||1.07|0.992|
72417631|NCT03232983|144345707|SUPERIORITY||Ratio of Geometric Least Squares Means|1.0|||||TWO_SIDED|90.0|0.962|1.04|||Mixed Models Analysis|||Geometric LSMeans were controlled for injection site, study period, and sequence as fixed effects, and subject within sequence as a random effect.||1.04|0.962|
72608958|NCT00402727|144746654|NON_INFERIORITY_OR_EQUIVALENCE|Sample size estimation was based on the primary efficacy variable.|Difference of eradication rates (in %)|-0.1||||||95.0|-6.9|5.4|||||A positive value indicates an advantage for the treatment group of moxifloxacin, a negative value an advantage for the comparator group|Calculated were 95% confidence intervals for the difference in success rates between treatment groups (moxifloxacin minus comparator). Method as described in Koch et al.||5.4|-6.9|
72608959|NCT00402727|144746655|NON_INFERIORITY_OR_EQUIVALENCE|Sample size estimation was based on the primary efficacy variable.|Difference of eradication rates (in %)|-2.9||||||95.0|-9.3|2.2|||||A positive value indicates an advantage for the treatment group of moxifloxacin, a negative value an advantage for the comparator group|Calculated were 95% confidence intervals for the difference in success rates between treatment groups (moxifloxacin minus comparator). Method as described in Koch et al.||2.2|-9.3|
72417632|NCT03232983|144345708|SUPERIORITY||Ratio of Geometric LSMeans|1.09|||||TWO_SIDED|90.0|1.0|1.2|||Mixed Models Analysis|||Geometric LSMeans were controlled for injection site, study period, and sequence as fixed effects, and subject within sequence as a random effect.||1.20|1.00|
72417633|NCT03232983|144345708|SUPERIORITY||Ratio of Geometric LSMeans|1.14|||||TWO_SIDED|90.0|1.04|1.25|||Mixed Models Analysis|||Geometric LSMeans were controlled for injection site, study period, and sequence as fixed effects, and subject within sequence as a random effect.||1.25|1.04|
72417634|NCT02606903|144345709|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means (%)|110.19|STANDARD_DEVIATION|33.603|||TWO_SIDED|90.0|96.8|125.44|||ANOVA||Relative bioavailability was estimated by the ratio (AI/PFS) of the adjusted geometric means (gMean). Standard deviation is actually inter-individual geometric coefficient of variation (%).|Analysis of variance (ANOVA) model on the log scale was used including treatment and body mass index (BMI) group as fixed effects||125.44|96.80|
72417635|NCT02606903|144345710|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means (%)|100.14|STANDARD_DEVIATION|42.354|||TWO_SIDED|90.0|85.15|117.76|||ANOVA||Relative bioavailability was estimated by the ratio (AI/PFS) of the adjusted geometric means (gMean). Standard deviation is actually inter-individual geometric coefficient of variation (%).|Analysis of variance (ANOVA) model on the log scale was used including treatment and BMI group as fixed effects||117.76|85.15|
72417636|NCT02606903|144345711|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means (%)|100.22|STANDARD_DEVIATION|53.137|||TWO_SIDED|90.0|82.13|122.29|||ANOVA||Relative bioavailability was estimated by the ratio (AI/PFS) of the adjusted geometric means (gMean). Standard deviation is actually inter-individual geometric coefficient of variation (%).|Analysis of variance (ANOVA) model on the log scale was used including treatment and BMI group as fixed effects||122.29|82.13|
72417637|NCT02548455|144345713|EQUIVALENCE|Freedom from left ventricular lead-related complications through 3 months was estimated to be 96.0% with a 95% lower confidence bound of 92.6% based on the Promote Q IDE study (NCT00990665), and 98.3% with a 95% lower confidence bound of 97.7% based on data from the Quadripolar Post-Approval study (NCT01555619).|Kaplan-Meier Estimate|85.0||||0.05|TWO_SIDED||||||Log Rank|||"The hypothesis for the endpoint is:~H0: Freedom from LV lead-related complications through 3 months (91 days) ≤ 85% H1: Freedom from LV lead-related complications through 3 months (91 days) \> 85%~A total of 85 subjects were required to have at least 80% power to reject the null hypothesis at the 5% significance level at three months (91 days) post-implant or attempted implant. After accounting for 9% attrition, the required sample size was 94 subjects."||||0.05
72417638|NCT02436330|144345732|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.0615||||0.0967|TWO_SIDED|95.0|-0.1344|0.0115||We checked the distribution of bmiz changes between baseline and 6 months, and there is one subject from control group had bigger changes than others. After excluding this subject, the results are still similar with previous.|t-test, 2 sided|||||0.0115|-0.1344|0.0967
72417639|NCT02436330|144345733|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.0775||||0.0335|TWO_SIDED|95.0|-0.1485|-0.00652|||t-test, 2 sided|||||-0.00652|-0.1485|0.0335
72417640|NCT02436330|144345734|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0||||0.991|TWO_SIDED|95.0|-5.2|5.1|||t-test, 2 sided|||||5.1|-5.2|0.991
72417641|NCT02436330|144345735|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.0||||0.851|TWO_SIDED|95.0|-9.0|11.0|||t-test, 2 sided|||||11|-9|0.851
72417642|NCT02436330|144345736|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.9||||0.501|TWO_SIDED|95.0|-11.7|5.8|||t-test, 2 sided|||||5.8|-11.7|0.501
72417643|NCT02436330|144345737|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.2971||||0.035|TWO_SIDED|95.0|0.0224|0.5718|||t-test, 2 sided|||||0.5718|0.0224|0.035
72417644|NCT02436330|144345738|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.9464||||0.2207|TWO_SIDED|95.0|-2.4954|0.6025|||t-test, 2 sided|||||0.6025|-2.4954|0.2207
72417645|NCT02436330|144345739|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.0491||||0.4164|TWO_SIDED|95.0|-3.6407|1.5425|||t-test, 2 sided|||||1.5425|-3.6407|0.4164
72608960|NCT03188055|144746656|SUPERIORITY|||||||0.006|||||||t-test, 2 sided|||||||0.006
72608961|NCT03188055|144746657|SUPERIORITY|||||||0.709|||||||t-test, 2 sided|||||||0.709
72325586|NCT02525679|144174725|SUPERIORITY_OR_OTHER_LEGACY||Slope|1.0207|STANDARD_ERROR_OF_MEAN|0.0261|||TWO_SIDED|95.0|0.9668|1.0747|||||Based on the estimate for the slope parameter, a two sided 95% confidence interval for the slope was computed. Perfect dose proportionality would correspond to a slope of 1. Standard error (SE) of the mean is actually SE of the slope.|Dose proportionality in plasma for Cmax (log-transformed scale) was explored based on the linear regression model.||1.0747|0.9668|
72608962|NCT03188055|144746658|SUPERIORITY|||||||0.03|||||||t-test, 2 sided|||||||0.03
72608963|NCT03188055|144746659|SUPERIORITY|||||||0.063|||||||t-test, 2 sided|||||||0.063
72608964|NCT03188055|144746660|SUPERIORITY|||||||0.892|||||||t-test, 2 sided|||||||0.892
72608965|NCT03188055|144746661|SUPERIORITY||||||>|0.99||||||Using an a priori statistical significance of 0.05.|Fisher Exact|||Comparison of concordance status by intervention status (outcome by predictor).||||> . 99
72608966|NCT03188055|144746662|SUPERIORITY|||||||0.188|||||||t-test, 2 sided|||||||0.188
72608967|NCT03188055|144746663|SUPERIORITY|||||||0.042|||||||t-test, 2 sided|||||||0.042
72608968|NCT03188055|144746665|SUPERIORITY|||||||0.698|||||||t-test, 2 sided|||||||0.698
72608969|NCT03188055|144746666|SUPERIORITY|||||||0.15|||||||t-test, 2 sided|||||||0.15
72417646|NCT02436330|144345740|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2433.7||||0.812|TWO_SIDED|95.0|-18579.7|23447.2|||t-test, 2 sided|||||23447.2|-18579.7|0.812
72417647|NCT02436330|144345741|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.2837||||0.3326|TWO_SIDED|95.0|-0.3037|0.8711|||t-test, 2 sided|||||0.8711|-0.3037|0.3326
72417648|NCT02436330|144345742|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.2995||||0.1856|TWO_SIDED|95.0|-0.2051|0.8041|||t-test, 2 sided|||||0.8041|-0.2051|0.1856
72417649|NCT02436330|144345743|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-247.9||||0.0849|TWO_SIDED|95.0|-531.7|35.8686|||t-test, 2 sided|||||35.8686|-531.7|0.0849
72417650|NCT02436330|144345744|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.2048||||0.176|TWO_SIDED|95.0|-10.3835|1.974|||t-test, 2 sided|||||1.9740|-10.3835|0.176
72417651|NCT02436330|144345745|SUPERIORITY_OR_OTHER||Mean Difference (Net)|7.2151||||0.0247|TWO_SIDED|95.0|0.973|13.457|||t-test, 2 sided|||||13.457|0.973|0.0247
72417652|NCT02436330|144345746|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.8169||||0.2764|TWO_SIDED|95.0|-2.4147|0.7808|||t-test, 2 sided|||||0.7808|-2.4147|0.2764
72417653|NCT02436330|144345747|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.7958||||0.0008|TWO_SIDED|95.0|-1.235|-0.3566|||t-test, 2 sided|||||-0.3566|-1.2350|0.0008
72417654|NCT02436330|144345748|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.7024||||0.6974|TWO_SIDED|95.0|-2.9377|4.3425|||t-test, 2 sided|||||4.3425|-2.9377|0.6974
72417655|NCT02436330|144345750|SUPERIORITY_OR_OTHER|||||||0.2122|TWO_SIDED||||||t-test, 2 sided|||||||0.2122
72417656|NCT02436330|144345751|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.61||||0.1265|TWO_SIDED|95.0|-1.15|8.33|||t-test, 2 sided|||||8.33|-1.15|0.1265
72417657|NCT02436330|144345752|SUPERIORITY_OR_OTHER|||||||0.3671|TWO_SIDED||||||t-test, 2 sided|||||||0.3671
72417658|NCT02436330|144345753|SUPERIORITY_OR_OTHER|||||||0.4892|TWO_SIDED||||||t-test, 2 sided|||||||0.4892
72417659|NCT00162370|144345767|SUPERIORITY_OR_OTHER_LEGACY|||||||0.014|||||||Regression, Cox|||The null hypothesis evaluated is that the scores are not associated with outcome. Of the two measures, wall motion index is considered to be the primary endpoint measure. The cardiac event rate will be summarized by categorical levels of wall motion index score and the difference in wall motion index score.||||0.014
72417660|NCT00162370|144345768|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||Regression, Cox|||||||<0.0001
72417661|NCT04575051|144345779|SUPERIORITY||Mean Difference (Final Values)|0.43||||0.58|TWO_SIDED|95.0|-1.1|1.96|||Mixed Models Analysis||Difference in the adjusted means for the Consult model and HearCARE model.|The null hypothesis is that the HearCARE intervention does not improve satisfaction with social participation.||1.96|-1.10|0.58
72417662|NCT04575051|144345780|SUPERIORITY||Mean Difference (Final Values)|-0.03||||0.95|TWO_SIDED|95.0|-1.13|1.1|||Mixed Models Analysis||The estimated parameter represents the difference between the adjusted means for the Consult and HearCARE models.|The null hypothesis is that the HearCARE intervention does not improve hearing related quality of life.||1.10|-1.13|0.95
72608970|NCT00944710|144746676|SUPERIORITY_OR_OTHER||Risk Difference (RD)|1.0||||0.33|TWO_SIDED|95.0|-10.0|30.0|||Binomial regression|adjusted for visual acuity at randomization||||30|-10|0.33
72608971|NCT00944710|144746681|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.05||||0.12|TWO_SIDED|95.0|-0.01|0.12|||ANCOVA|The ANCOVA model included amblyopic eye visual acuity at randomization as an adjustment covariate.|Positive values favor the Intensified Treatment group|The primary analysis was a treatment group comparison of the masked 10-week amblyopic eye visual acuity using an analysis of covariance (ANCOVA) model, adjusting for visual acuity at randomization. The analysis was a 2-sided test for efficacy to test the null hypothesis of no treatment difference, assuming 90% power and a type I error rate of 5%.||0.12|-0.01|0.12
72417663|NCT04575051|144345781|SUPERIORITY||Mean Difference (Final Values)|-0.03||||0.96|TWO_SIDED|95.0|-1.2|1.14|||Mixed Models Analysis||Estimated Value represents the difference in the means for the Consult and HearCARE models.|||1.14|-1.20|0.96
72417664|NCT04575051|144345782|SUPERIORITY||Mean Difference (Final Values)|0.21||||0.13|TWO_SIDED|95.0|-0.07|0.48|||Mixed Models Analysis||The Estimated Value is the difference between the means of the Consult and HearCARE models.|||0.48|-0.07|0.13
72608972|NCT00944710|144746689|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.1||||0.55|TWO_SIDED|95.0|-0.23|0.43|||ANCOVA|||A treatment group difference in fellow-eye visual acuity change at the 12-week exam was evaluated using an ANCOVA model, adjusting for the fellow-eye visual acuity at randomization.||0.43|-0.23|0.55
72608973|NCT00944710|144746698|SUPERIORITY_OR_OTHER|||||||0.23|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||The distribution of 12-week Randot Preschool Stereoacuity scores was compared between treatment groups using a Wilcoxon rank sum test.||||0.23
72608974|NCT00944710|144746699|SUPERIORITY_OR_OTHER|||||||0.66|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||The distribution of 12-week Randot Preschool Stereoacuity scores was compared between treatment groups using a Wilcoxon rank sum test.||||0.66
72608975|NCT00264147|144746700|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||Overall alpha=0.05 for multiple comparisons with a step-down procedure (p-values subsequent to the first non-significant p-value were not reported).|Cochran-Armitage trend test|A step-down procedure and Abelson-Tukey scaling were used for the trend test.||||||<0.001
72608976|NCT00264147|144746700|SUPERIORITY_OR_OTHER_LEGACY|||||||0.057||95.0||||Overall alpha=0.05 for multiple comparisons with a step-down procedure (p-values subsequent to the first non-significant p-value were not reported).|Cochran-Armitage trend test|A step-down procedure and Abelson-Tukey scaling were used for the trend test.||||||0.057
72608977|NCT00264147|144746700|SUPERIORITY_OR_OTHER_LEGACY||difference in percentage of patients|18.53||||||95.0|7.84|28.65|||||CI based on the Wilson's score method.|||28.65|7.84|
72608978|NCT00264147|144746700|SUPERIORITY_OR_OTHER_LEGACY||difference in percentage of patients|10.0||||||95.0|-0.66|20.46|||||CI based on the Wilson's score method.|||20.46|-0.66|
72608979|NCT00264147|144746700|SUPERIORITY_OR_OTHER_LEGACY||difference in percentage of patients|9.18||||||95.0|-1.25|19.39|||||CI based on the Wilson's score method.|||19.39|-1.25|
72608980|NCT00264147|144746700|SUPERIORITY_OR_OTHER_LEGACY||difference in percentage of patients|6.49||||||95.0|-3.76|16.61|||||CI based on the Wilson's score method.|||16.61|-3.76|
72608981|NCT00264147|144746701|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002||95.0||||Overall alpha=0.05 for multiple comparisons with a step-down procedure (p-values subsequent to the first non-significant p-value were not reported).|ANCOVA|Based on a trend test with a step-down procedure and Abelson-Tukey scaling.||||||0.002
72608982|NCT00264147|144746701|SUPERIORITY_OR_OTHER_LEGACY|||||||0.221||95.0||||Overall alpha=0.05 for multiple comparisons with a step-down procedure (p-values subsequent to the first non-significant p-value were not reported).|ANCOVA|Based on a trend test with a step-down procedure and Abelson-Tukey scaling.||||||0.221
72608983|NCT00264147|144746701|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.06||||||95.0|-6.44|-1.68||||||||-1.68|-6.44|
72608984|NCT00264147|144746701|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.49||||||95.0|-3.91|0.93||||||||0.93|-3.91|
72608985|NCT00264147|144746701|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.74||||||95.0|-5.13|-0.35||||||||-0.35|-5.13|
72608986|NCT00264147|144746701|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.5||||||95.0|-4.88|-0.12||||||||-0.12|-4.88|
72608987|NCT00264147|144746702|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001||95.0||||Overall alpha=0.05 for multiple comparisons with a step-down procedure (p-values subsequent to the first non-significant p-value were not reported).|ANCOVA|Based on a trend test with a step-down procedure and Abelson-Tukey scaling.||||||0.001
72608988|NCT00264147|144746702|SUPERIORITY_OR_OTHER_LEGACY|||||||0.125||95.0||||Overall alpha=0.05 for multiple comparisons with a step-down procedure (p-values subsequent to the first non-significant p-value were not reported).|ANCOVA|Based on a trend test with a step-down procedure and Abelson-Tukey scaling.||||||0.125
72608989|NCT00264147|144746702|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.24||||||95.0|-3.64|-0.84||||||||-0.84|-3.64|
72608990|NCT00264147|144746702|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.02||||||95.0|-2.44|0.41||||||||0.41|-2.44|
72608991|NCT00264147|144746702|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.22||||||95.0|-2.63|0.18||||||||0.18|-2.63|
72608992|NCT00264147|144746702|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.49||||||95.0|-1.89|0.91||||||||0.91|-1.89|
72608993|NCT00264147|144746703|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||Overall alpha=0.05 for multiple comparisons with a step-down procedure (p-values subsequent to the first non-significant p-value were not reported).|ANCOVA|Based on a trend test with a step-down procedure and Abelson-Tukey scaling.||||||<0.001
72608994|NCT00264147|144746703|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||Overall alpha=0.05 for multiple comparisons with a step-down procedure (p-values subsequent to the first non-significant p-value were not reported).|ANCOVA|Based on a trend test with a step-down procedure and Abelson-Tukey scaling.||||||<0.001
72608995|NCT00264147|144746703|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||Overall alpha=0.05 for multiple comparisons with a step-down procedure (p-values subsequent to the first non-significant p-value were not reported).|ANCOVA|Based on a trend test with a step-down procedure and Abelson-Tukey scaling.||||||<0.001
72608996|NCT00264147|144746703|SUPERIORITY_OR_OTHER_LEGACY|||||||0.023||95.0||||Overall alpha=0.05 for multiple comparisons with a step-down procedure (p-values subsequent to the first non-significant p-value were not reported).|ANCOVA|Based on a trend test with a step-down procedure and Abelson-Tukey scaling.||||||0.023
72608997|NCT00264147|144746703|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-14.16||||||95.0|-19.38|-8.95||||||||-8.95|-19.38|
72608998|NCT00264147|144746703|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-9.21||||||95.0|-14.52|-3.9||||||||-3.90|-14.52|
72608999|NCT00264147|144746703|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-8.87||||||95.0|-14.11|-3.63||||||||-3.63|-14.11|
72609000|NCT00264147|144746703|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.05||||||95.0|-11.27|-0.83||||||||-0.83|-11.27|
72609001|NCT00264147|144746704|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||Overall alpha=0.05 for multiple comparisons with a step-down procedure (p-values subsequent to the first non-significant p-value were not reported).|ANCOVA|Based on a trend test with a step-down procedure and Abelson-Tukey scaling.||||||<0.001
72417665|NCT03624504|144345783|OTHER|Assume expected performance to be 94%. The Objective Performance Criterion (OPC) is set at 83% (same performance threshold in FDA approved global study). Assumes 0.05 significance level, 2-sided, 80% power and 10% study attrition.|Kaplan-Meier survival probability (%)|97.6||||0.0021|TWO_SIDED|95.0|90.6|99.4||The threshold for significance was 0.05.|z test, 1-sided||The major complication free rate (i.e. survival probability) was estimated using the Kaplan-Meier method.|"Null hypothesis: Major complication free rate at 6 months post-implant is less than or equal to 83%~Alternative hypothesis: Major complication free rate at 6 months post-implant is greater than 83%."||99.4|90.6|0.0021
72417666|NCT04496219|144345806|SUPERIORITY|||||||0.97|||||||t-test, 2 sided|||This p value relates to instillation adherence||||0.97
72417667|NCT04496219|144345806|SUPERIORITY|||||||0.17|||||||t-test, 2 sided|||This p value relates to missed visits.||||0.17
72417668|NCT04496219|144345807|SUPERIORITY|||||||0.5638|||||||Chi-squared|||For the patient survey, the two arms will be compared using chi-squared. This analysis is for Constipation Symptoms.||||0.5638
72417669|NCT04496219|144345807|SUPERIORITY|||||||0.1753|||||||Chi-squared|||For the patient survey, the two arms will be compared using chi-squared. This analysis is for Diarrhea Symptoms.||||0.1753
72417670|NCT04496219|144345807|SUPERIORITY|||||||0.2062|||||||Chi-squared|||For the patient survey, the two arms will be compared using chi-squared. This analysis is for Urinary Symptoms.||||0.2062
72417671|NCT04496219|144345808|SUPERIORITY|||||||0.8092|||||||Chi-squared|||For the patient survey, the two arms will be compared using chi-squared. This analysis is for Global Health.||||0.8092
72417672|NCT04496219|144345808|SUPERIORITY|||||||0.5492|||||||Chi-squared|||For the patient survey, the two arms will be compared using chi-squared. This analysis is for Physical Function.||||0.5492
72417673|NCT04496219|144345808|SUPERIORITY|||||||0.6464|||||||Chi-squared|||For the patient survey, the two arms will be compared using chi-squared. This analysis is for Emotional Function.||||0.6464
72417674|NCT04496219|144345808|SUPERIORITY|||||||0.586|||||||Chi-squared|||For the patient survey, the two arms will be compared using chi-squared. This analysis is for Social Function.||||0.586
72417675|NCT04496219|144345808|SUPERIORITY|||||||0.8999|||||||Chi-squared|||For the patient survey, the two arms will be compared using chi-squared. This analysis is for Fatigue Symptoms.||||0.8999
72417676|NCT04496219|144345808|SUPERIORITY|||||||0.2007|||||||Chi-squared|||For the patient survey, the two arms will be compared using chi-squared. This analysis is for Pain Symptoms.||||0.2007
72417677|NCT04496219|144345808|SUPERIORITY|||||||0.9921|||||||Chi-squared|||For the patient survey, the two arms will be compared using chi-squared. This analysis is for Malaise Symptoms.||||0.9921
72609002|NCT00264147|144746704|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||Overall alpha=0.05 for multiple comparisons with a step-down procedure (p-values subsequent to the first non-significant p-value were not reported).|ANCOVA|Based on a trend test with a step-down procedure and Abelson-Tukey scaling.||||||<0.001
72609003|NCT00264147|144746704|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||Overall alpha=0.05 for multiple comparisons with a step-down procedure (p-values subsequent to the first non-significant p-value were not reported).|ANCOVA|Based on a trend test with a step-down procedure and Abelson-Tukey scaling.||||||<0.001
72417678|NCT04496219|144345808|SUPERIORITY|||||||0.5723|||||||Chi-squared|||For the patient survey, the two arms will be compared using chi-squared. This analysis is for Role Function.||||0.5723
72417679|NCT04496219|144345808|SUPERIORITY|||||||0.812|||||||Chi-squared|||For the patient survey, the two arms will be compared using chi-squared. This analysis is for Cognitive Function.||||0.812
72417680|NCT04496219|144345808|SUPERIORITY|||||||0.96|||||||Chi-squared|||For the patient survey, the two arms will be compared using chi-squared. This analysis is for Nausea Symptoms.||||0.96
72417681|NCT04496219|144345808|SUPERIORITY|||||||0.1062|||||||Chi-squared|||For the patient survey, the two arms will be compared using chi-squared. This analysis is for Dyspnoea Symptoms.||||0.1062
72417682|NCT04496219|144345808|SUPERIORITY|||||||0.3259|||||||Chi-squared|||For the patient survey, the two arms will be compared using chi-squared. This analysis is for Insomnia Symptoms.||||0.3259
72417683|NCT04496219|144345808|SUPERIORITY|||||||0.9664|||||||Chi-squared|||For the patient survey, the two arms will be compared using chi-squared. This analysis is for Appetite Loss Symptoms.||||0.9664
72417684|NCT04496219|144345808|SUPERIORITY|||||||0.4564|||||||Chi-squared|||For the patient survey, the two arms will be compared using chi-squared. This analysis is for Finances.||||0.4564
72417685|NCT04496219|144345808|SUPERIORITY|||||||0.1036|||||||Chi-squared|||For the patient survey, the two arms will be compared using chi-squared. This analysis is for Intravesical Symptoms.||||0.1036
72417686|NCT04496219|144345808|SUPERIORITY|||||||0.1789|||||||Chi-squared|||For the patient survey, the two arms will be compared using chi-squared. This analysis is for Worries.||||0.1789
72417687|NCT04496219|144345808|SUPERIORITY|||||||0.5186|||||||Chi-squared|||For the patient survey, the two arms will be compared using chi-squared. This analysis is for Bloating Symptoms.||||0.5186
72417688|NCT04496219|144345808|SUPERIORITY|||||||0.0757|||||||Chi-squared|||For the patient survey, the two arms will be compared using chi-squared. This analysis is for Sexual Function.||||0.0757
72417689|NCT04496219|144345808|SUPERIORITY|||||||0.1174|||||||Chi-squared|||For the patient survey, the two arms will be compared using chi-squared. This analysis is for Male Sex Problems.||||0.1174
72417690|NCT04496219|144345808|SUPERIORITY|||||||0.3129|||||||Chi-squared|||For the patient survey, the two arms will be compared using chi-squared. This analysis is for Intimacy.||||0.3129
72417691|NCT01239030|144345855|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0046|||||||ANCOVA|||||||0.0046
72417692|NCT00829387|144345856|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.39||||0.47|TWO_SIDED|95.0|-1.47|0.69|||Linear mixed model|||||0.69|-1.47|0.47
72417693|NCT00829387|144345857|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.34||||0.4|TWO_SIDED|95.0|-1.15|0.47|||linear mixed model|||baseline to 36 weeks post-baseline||0.47|-1.15|0.40
72417694|NCT00829387|144345858|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.35||||0.31|TWO_SIDED|95.0|-7.02|2.32|||Linear mixed model|||baseline to 12 weeks post-baseline||2.32|-7.02|0.31
72417695|NCT00829387|144345859|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01||||0.98|TWO_SIDED|95.0|-1.03|1.06|||linear mixed model|||baseline to 12 weeks comparison||1.06|-1.03|0.98
72417696|NCT00829387|144345860|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.92||||0.03|TWO_SIDED|95.0|-1.76|-0.07|||linear mixed model|||baseline to 36 weeks post-baseline||-0.07|-1.76|0.03
72417697|NCT00829387|144345861|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.16||||0.15|TWO_SIDED|95.0|-9.86|1.55|||linear mixed model|||baseline to 36 weeks post-baseline||1.55|-9.86|0.15
72417698|NCT01112579|144345862|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.4||||0.3|TWO_SIDED|95.0|-2.0|14.9|||ANCOVA|||||14.9|-2.0|0.3
72417699|NCT01112579|144345863|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-106.1||||0.79|TWO_SIDED|95.0|-845.8|633.6|||ANCOVA|||||633.6|-845.8|0.79
72417700|NCT01112579|144345864|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.8||||0.93|TWO_SIDED|95.0|-1.6|3.2|||ANCOVA|||||3.2|-1.6|0.93
72417701|NCT00818753|144345865|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.0||||||95.0|0.08|12.76||p-values were not presented as the study was exploratory and not powered to to detect a difference in the treatments|Cochran-Mantel-Haenszel|||Dabigatran 110mg BID vs Heparin||12.76|0.08|
72417702|NCT00818753|144345865|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.5||||||95.0|0.13|16.82||p-values were not presented as the study was exploratory and not powered to to detect a difference in the treatments|Cochran-Mantel-Haenszel|||Dabigatran 150mg BID vs Heparin||16.82|0.13|
72609004|NCT00264147|144746704|SUPERIORITY_OR_OTHER_LEGACY|||||||0.018||95.0||||Overall alpha=0.05 for multiple comparisons with a step-down procedure (p-values subsequent to the first non-significant p-value were not reported).|ANCOVA|Based on a trend test with a step-down procedure and Abelson-Tukey scaling.||||||0.018
72417703|NCT01951625|144345886|OTHER||Log-Scale mean difference|-0.122|||=|0.1506|TWO_SIDED|90.0|-0.32|0.07|||t-test, 1 sided|||For the primary analysis, the three highest active treatment groups (BAY1021189 2.5mg, BAY1021189 2.5 to 5mg, BAY1021189 2.5 to 10mg) were pooled and compared to the assigned placebo treatment group with a one-sided two-sample t-test at the significance level of 5 percent (%). Results are reported including 90% confidence intervals (CI) for the difference of means. The difference between the pooled treatment group and the placebo group is difference of means on the log scale.||0.07|-0.32|= 0.1506
72417704|NCT01951625|144345886|OTHER||Log-Scale mean difference|-0.2494|||=|0.0483|TWO_SIDED|90.0|-0.5|0.0|||t-test, 1 sided|||In case of a significant result in the primary analysis of the primary endpoint, pairwise comparisons to Placebo were performed in a hierarchical manner (from BAY1021189 from 2.5 to 10mg dose arm to BAY1021189 1.25mg dose arm). In case of non-significance of the primary analyses, these secondary analyses were specified as exploratory only, since the primary analyses were not significant.||0|-0.5|= 0.0483
72417705|NCT01951625|144345886|OTHER||Log-Scale mean difference|-0.0731|||=|0.3042|TWO_SIDED|90.0|-0.31|0.16|||t-test, 1 sided|||In case of a significant result in the primary analysis of the primary endpoint, pairwise comparisons to Placebo were performed in a hierarchical manner (from BAY1021189 from 2.5 to 10mg dose arm to BAY1021189 1.25mg dose arm). In case of non-significance of the primary analyses, these secondary analyses were specified as exploratory only, since the primary analyses were not significant.||0.16|-0.31|= 0.3042
72417706|NCT01951625|144345886|OTHER||Log-Scale mean difference|-0.0396|||=|0.3841|TWO_SIDED|90.0|-0.26|0.18|||t-test, 1 sided|||In case of a significant result in the primary analysis of the primary endpoint, pairwise comparisons to Placebo were performed in a hierarchical manner (from BAY1021189 from 2.5 to 10mg dose arm to BAY1021189 1.25mg dose arm). In case of non-significance of the primary analyses, these secondary analyses were specified as exploratory only, since the primary analyses were not significant.||0.18|-0.26|= 0.3841
72417707|NCT01951625|144345886|OTHER||Log-Scale mean difference|0.0151|||=|0.5444|TWO_SIDED|90.0|-0.21|0.24|||t-test, 1 sided|||In case of a significant result in the primary analysis of the primary endpoint, pairwise comparisons to Placebo were performed in a hierarchical manner (from BAY1021189 from 2.5 to 10mg dose arm to BAY1021189 1.25mg dose arm). In case of non-significance of the primary analyses, these secondary analyses were specified as exploratory only.||0.24|-0.21|= 0.5444
72417708|NCT02459574|144345902|SUPERIORITY||Hazard Ratio (HR)|0.156|||<|0.0001|TWO_SIDED|95.0|0.097|0.25||Bonferonni corrected alpha of 0.05/2 = 0.025|Log Rank||95% Wald Confidence Limits Point estimate relates to AVATAR-AF in relation to Anti-Arrhythmic Therapy|Primary Analysis - AVATAR-AF vs Anti-Arrhythmic Therapy||0.250|0.097|<0.0001
72417709|NCT02459574|144345902|SUPERIORITY||Hazard Ratio (HR)|1.173||||0.6061|TWO_SIDED|95.0|0.639|2.154||Bonferonni corrected alpha 0.05/2 = 0.025|Log Rank||95% Wald Confidence Limits Point estimate relates to AVATAR-AF in relation to Conventional Ablation|Secondary analysis of Primary Outcome measure - AVATAR-AF vs Conventional Ablation||2.154|0.639|0.6061
72417710|NCT00251745|144345906|SUPERIORITY_OR_OTHER||||||<|1e-05||||||The overall 0.0025 level of significance for the multiple comparisons of each dexlansoprazole MR dose to placebo was controlled using Hochberg's method.|Wilcoxon (Mann-Whitney)|||The comparison between the two treatment groups was made using Wilcoxon rank-sum test.||||<0.00001
72417711|NCT00251745|144345906|SUPERIORITY_OR_OTHER||||||<|1e-05||||||The overall 0.0025 level of significance for the multiple comparisons of each dexlansoprazole MR dose to placebo was controlled using Hochberg's method.|Wilcoxon (Mann-Whitney)|||The comparison between the two treatment groups was made using Wilcoxon rank-sum test.||||<0.00001
72417712|NCT00251745|144345906|SUPERIORITY_OR_OTHER|||||||0.15505||||||Statistical significance was determined at 0.0025 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||The comparison between the two treatment groups was made using Wilcoxon rank-sum test.||||0.15505
72417713|NCT00251745|144345908|SUPERIORITY_OR_OTHER|||||||1e-05||||||The overall 0.0025 level of significance for the multiple comparisons of each dexlansoprazole MR dose to placebo was controlled using Hochberg's method.|Wilcoxon (Mann-Whitney)|||The comparison between the two treatment groups was made using Wilcoxon rank-sum test.||||0.00001
72609005|NCT00264147|144746704|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.56||||||95.0|-0.77|-0.35||||||||-0.35|-0.77|
72609006|NCT00264147|144746704|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.34||||||95.0|-0.55|-0.13||||||||-0.13|-0.55|
72609007|NCT00264147|144746704|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.4||||||95.0|-0.61|-0.19||||||||-0.19|-0.61|
72609008|NCT00264147|144746704|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.25||||||95.0|-0.46|-0.04||||||||-0.04|-0.46|
72609009|NCT00264147|144746705|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||Overall alpha=0.05 for multiple comparisons with a step-down procedure (p-values subsequent to the first non-significant p-value were not reported).|ANCOVA|Based on a trend test with a step-down procedure and Abelson-Tukey scaling.||||||<0.001
72609010|NCT00264147|144746705|SUPERIORITY_OR_OTHER_LEGACY|||||||0.018||95.0||||Overall alpha=0.05 for multiple comparisons with a step-down procedure (p-values subsequent to the first non-significant p-value were not reported).|ANCOVA|Based on a trend test with a step-down procedure and Abelson-Tukey scaling.||||||0.018
72417714|NCT00251745|144345908|SUPERIORITY_OR_OTHER||||||<|1e-05||||||The overall 0.0025 level of significance for the multiple comparisons of each dexlansoprazole MR dose to placebo was controlled using Hochberg's method.|Wilcoxon (Mann-Whitney)|||The comparison between the two treatment groups was made using Wilcoxon rank-sum test.||||<0.00001
72417715|NCT00251745|144345908|SUPERIORITY_OR_OTHER|||||||0.3874||||||Statistical significance was determined at 0.0025 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||The comparison between the two treatment groups was made using Wilcoxon rank-sum test.||||0.38740
72417716|NCT00636649|144345912|SUPERIORITY_OR_OTHER|||||||0.993|||||||ANCOVA|||CISS-TASK||||0.993
72417717|NCT00636649|144345912|SUPERIORITY_OR_OTHER|||||||0.185|||||||ANCOVA|||CISS-EMOT||||0.185
72417718|NCT00636649|144345912|SUPERIORITY_OR_OTHER|||||||0.196|||||||ANCOVA|||CISS-DIS||||0.196
72417719|NCT00636649|144345912|SUPERIORITY_OR_OTHER|||||||0.759|||||||ANCOVA|||CISS-AVD||||0.759
72417720|NCT00636649|144345912|SUPERIORITY_OR_OTHER|||||||0.396|||||||ANCOVA|||CISS-SOC||||0.396
72609011|NCT00264147|144746705|SUPERIORITY_OR_OTHER_LEGACY|||||||0.017||95.0||||Overall alpha=0.05 for multiple comparisons with a step-down procedure (p-values subsequent to the first non-significant p-value were not reported).|ANCOVA|Based on a trend test with a step-down procedure and Abelson-Tukey scaling.||||||0.017
72609012|NCT00264147|144746705|SUPERIORITY_OR_OTHER_LEGACY|||||||0.08||95.0||||Overall alpha=0.05 for multiple comparisons with a step-down procedure (p-values subsequent to the first non-significant p-value were not reported).|ANCOVA|Based on a trend test with a step-down procedure and Abelson-Tukey scaling.||||||0.080
72417721|NCT00636649|144345913|SUPERIORITY_OR_OTHER|||||||0.579|||||||ANCOVA|||||||0.579
72417722|NCT00636649|144345914|SUPERIORITY_OR_OTHER|||||||0.225|||||||ANCOVA|||TFEQ-RES||||0.225
72609013|NCT00264147|144746705|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-14.44||||||95.0|-19.62|-9.26||||||||-9.26|-19.62|
72609014|NCT00264147|144746705|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.22||||||95.0|-11.52|-0.92||||||||-0.92|-11.52|
72325587|NCT02525679|144174727|SUPERIORITY_OR_OTHER_LEGACY||Slope|2.7123|STANDARD_ERROR_OF_MEAN|0.2525|||TWO_SIDED|95.0|2.1856|3.2389|||||Based on the estimate for the slope parameter, a two sided 95% confidence interval for the slope was computed. Perfect dose proportionality would correspond to a slope of 1. Standard error (SE) of the mean is actually SE of the slope.|Dose proportionality in plasma for AUC(0-tz) (log-transformed scale) was explored based on the linear regression model.||3.2389|2.1856|
72417723|NCT00636649|144345914|SUPERIORITY_OR_OTHER|||||||0.498|||||||ANCOVA|||TFEQ-DIS||||0.498
72417724|NCT00636649|144345914|SUPERIORITY_OR_OTHER|||||||0.724|||||||ANCOVA|||TFEQ-HUN||||0.724
72417725|NCT03355326|144345941|SUPERIORITY|||||||0.971|||||||Wilcoxon (Mann-Whitney)|||||||0.971
72417726|NCT03355326|144345942|SUPERIORITY|||||||0.9|||||||Wilcoxon (Mann-Whitney)|||||||0.900
72417727|NCT03355326|144345943|SUPERIORITY|||||||0.648|||||||Wilcoxon (Mann-Whitney)|||||||0.648
72417728|NCT03355326|144345944|SUPERIORITY|||||||0.967|||||||Wilcoxon (Mann-Whitney)|||||||0.967
72417729|NCT03355326|144345945|SUPERIORITY||||||>|0.999|||||||Fisher Exact|||||||>0.999
72417730|NCT03355326|144345946|SUPERIORITY||||||>|0.999|||||||Fisher Exact|||||||>0.999
72417731|NCT03355326|144345947|SUPERIORITY||||||>|0.999|||||||Fisher Exact|||||||>0.999
72417732|NCT04333420|144345948|SUPERIORITY||LS means difference|-16.4||||0.3677|TWO_SIDED|95.0|-53.2|20.3|||Linear repeated measures model|||||20.3|-53.2|0.3677
72417733|NCT04333420|144345949|SUPERIORITY||Hazard Ratio (HR)|0.728||||0.0941|TWO_SIDED|95.0|0.502|1.056|||Regression, Cox|including stratification by site||Cox proportional hazards regression model with outcome 28-day all-cause mortality (censored time to event variable with event = Death) including stratification by site; 61 patients from sites with no events (no death) or from single patient sites with death factually make no contribution to the analysis outcome.||1.056|0.502|0.0941
72417734|NCT04333420|144345949|SUPERIORITY||Hazard Ratio (HR)|0.674||||0.0266|TWO_SIDED|95.0|0.476|0.955|||Regression, Cox|Without stratification by site||Cox proportional hazards regression model with outcome 28-day all-cause mortality (censored time to event variable with event = Death) without stratification by site; Post-hoc analysis||0.955|0.476|0.0266
72417735|NCT04333420|144345949|SUPERIORITY||Hazard Ratio (HR)|0.648||||0.0181|TWO_SIDED|95.0|0.453|0.929|||Regression, Cox|Including random effect for site (frailty model)||Cox proportional hazards regression model with outcome 28-day all-cause mortality (censored time to event variable with event = Death) including random effect for site (frailty model); Post-hoc analysis||0.929|0.453|0.0181
72417736|NCT04333420|144345949|SUPERIORITY||Hazard Ratio (HR)|0.613||||0.0067|TWO_SIDED|95.0|0.43|0.873|||Regression, Cox|Including stratification by country||Cox proportional hazards regression model with outcome 28-day all-cause mortality (censored time to event variable with event = Death) including stratification by country; Post-hoc analysis||0.873|0.430|0.0067
72609015|NCT00264147|144746705|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.32||||||95.0|-11.53|-1.12||||||||-1.12|-11.53|
72609016|NCT00264147|144746705|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.63||||||95.0|-9.81|0.55||||||||0.55|-9.81|
72609017|NCT05994963|144746725|OTHER||Ratio of adjusted geometric means|58.84|||||TWO_SIDED|90.0|40.45|85.6|||||The ratio (test/reference) and 90% CIs are expressed as percentages. Treatment A = reference; treatment B = test.|Analysis was performed using mixed effect model with sequence, period and treatment as fixed effects and participant within the sequence as a random effect.||85.60|40.45|
72417737|NCT04333420|144345949|SUPERIORITY||Risk Difference (RD)|-11.0||||0.0293|TWO_SIDED|95.0|-20.8|-1.2|||Regression, Logistic|Multiple imputation of missing values|Risk difference and lower/upper limit of the Confidence Interval are given in percent|Sensitivity analysis; 369 patients were included in this analysis including the patient that was randomized in error and not treated. Missing values were imputed by multiple imputation.||-1.2|-20.8|0.0293
72609018|NCT05994963|144746726|OTHER||Ratio of adjusted geometric means|56.93|||||TWO_SIDED|90.0|38.71|83.73|||||The ratio (test/reference) and 90% CIs are expressed as percentages. Treatment A = reference; treatment B = test.|Analysis was performed using mixed effect model with sequence, period and treatment as fixed effects and participant within the sequence as a random effect.||83.73|38.71|
72609019|NCT05994963|144746727|OTHER||Ratio of adjusted geometric means|50.13|||||TWO_SIDED|90.0|33.01|76.13|||||The ratio (test/reference) and 90% CIs are expressed as percentages. Treatment A = reference; treatment B = test.|Analysis was performed using mixed effect model with sequence, period and treatment as fixed effects and participant within the sequence as a random effect.||76.13|33.01|
72609020|NCT05994963|144746728|OTHER||Ratio of adjusted geometric means|202.52|||||TWO_SIDED|90.0|138.43|296.27|||||The ratio (test/reference) and 90% CIs are expressed as percentages. Treatment B = reference; treatment C = test.|Analysis was performed using mixed effect model with sequence, period and treatment as fixed effects and participant within the sequence as a random effect.||296.27|138.43|
72609021|NCT05994963|144746729|OTHER||Ratio of adjusted geometric means|196.11|||||TWO_SIDED|90.0|131.01|293.55|||||The ratio (test/reference) and 90% CIs are expressed as percentages. Treatment B = reference; treatment C = test.|Analysis was performed using mixed effect model with sequence, period and treatment as fixed effects and participant within the sequence as a random effect.||293.55|131.01|
72609022|NCT05994963|144746730|OTHER||Ratio of adjusted geometric means|230.22|||||TWO_SIDED|90.0|145.53|364.2|||||The ratio (test/reference) and 90% CIs are expressed as percentages. Treatment B = reference; treatment C = test.|Analysis was performed using mixed effect model with sequence, period and treatment as fixed effects and participant within the sequence as a random effect.||364.20|145.53|
72325588|NCT02525679|144174727|SUPERIORITY_OR_OTHER_LEGACY||Slope|1.0003|STANDARD_ERROR_OF_MEAN|0.0253|||TWO_SIDED|95.0|0.9482|1.0525|||||Based on the estimate for the slope parameter, a two sided 95% confidence interval for the slope was computed. Perfect dose proportionality would correspond to a slope of 1. Standard error (SE) of the mean is actually SE of the slope.|Dose proportionality in plasma for AUC(0-tz) (log-transformed scale) was explored based on the linear regression model.||1.0525|0.9482|
72609023|NCT05994963|144746731|OTHER||Ratio of adjusted geometric means|122.84|||||TWO_SIDED|90.0|93.61|161.19|||||The ratio (test/reference) and 90% CIs are expressed as percentages. Treatment B = reference; treatment D= test.|Analysis was performed using mixed effect model with sequence, period and treatment as fixed effects and participant within the sequence as a random effect.||161.19|93.61|
72609024|NCT05994963|144746732|OTHER||Ratio of adjusted geometric means|104.69|||||TWO_SIDED|90.0|94.54|115.94|||||The ratio (test/reference) and 90% CIs are expressed as percentages. Treatment B = reference; treatment D= test.|Analysis was performed using mixed effect model with sequence, period and treatment as fixed effects and participant within the sequence as a random effect.||115.94|94.54|
72609025|NCT05994963|144746733|OTHER||Ratio of adjusted geometric means|124.59|||||TWO_SIDED|90.0|93.46|166.09|||||The ratio (test/reference) and 90% CIs are expressed as percentages. Treatment B = reference; treatment D= test.|Analysis was performed using mixed effect model with sequence, period and treatment as fixed effects and participant within the sequence as a random effect.||166.09|93.46|
72609026|NCT01419535|144746744|SUPERIORITY|||||||0.6|||||||ANOVA|Repeated measures were analyzed by repeated-measures ANOVA including treatment group, time, and treatment\*time interaction as factors.||||||0.60
72325589|NCT04422431|144174733|OTHER|||||||0.1002|||||||t-test, 2 sided|||||||0.1002
72325590|NCT02317627|144174766|OTHER|No control group was used. Paired t-testing was used to determine the statistical significance of the mean change in Cohort 400 mg QD PASI from baseline to Week 12.||||||0.0282||||||Statistical significance was set at p ≤ 0.05. No adjustments for multiplicity were made. Missing data were not imputed.|t-test, 2 sided|||||||0.0282
72609027|NCT01419535|144746745|SUPERIORITY||||||<|0.001|||||||ANOVA|Repeated measures were analyzed by repeated-measures ANOVA including treatment group, time, and treatment\*time interaction as factors.||||||<0.001
72609028|NCT01419535|144746746|SUPERIORITY||||||<|0.001|||||||ANOVA|Repeated measures were analyzed by repeated-measures ANOVA including treatment group, time, and treatment\*time interaction as factors.||||||<0.001
72609029|NCT01419535|144746747|SUPERIORITY||||||<|0.001|||||||ANOVA|Repeated measures were analyzed by repeated-measures ANOVA including treatment group, time, and treatment\*time interaction as factors.||||||<0.001
72609030|NCT01419535|144746748|SUPERIORITY|||||||0.004|||||||ANOVA|Repeated measures were analyzed by repeated-measures ANOVA including treatment group, time, and treatment\*time interaction as factors.||||||0.004
72609031|NCT01419535|144746749|SUPERIORITY|||||||0.002|||||||ANOVA|Repeated measures were analyzed by repeated-measures ANOVA including treatment group, time, and treatment\*time interaction as factors.||||||0.002
72609032|NCT00720278|144746771|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.06|STANDARD_DEVIATION|0.47|<|0.001||95.0|-2.98|-1.14|||ANCOVA|ANCOVA is being used due to a covariate being included in the model. The covariate is baseline TNSS score.||Change in baseline to Day 14||-1.14|-2.98|<0.001
72609033|NCT00720278|144746771|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.0|STANDARD_DEVIATION|0.465|<|0.001||95.0|-3.91|-2.09|||ANCOVA|ANCOVA is being used due to a covariate being included in the model. The covariate is baseline TNSS score.||Change in baseline to Day 14||-2.09|-3.91|<0.001
72609034|NCT00720278|144746772|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.78|STANDARD_DEVIATION|0.479|<|0.001||95.0|-2.72|-0.84|||ANCOVA|ANCOVA is being used due to a covariate being included in the model. The covariate is baseline TNSS score.||Change in baseline to Day 14||-0.84|-2.72|<0.001
72609035|NCT00720278|144746772|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.668|STANDARD_DEVIATION|0.4735|<|0.001||95.0|-3.6|-1.74|||ANCOVA|ANCOVA is being used due to a covariate being included in the model. The covariate is baseline TNSS score.||Change in baseline to Day 14||-1.74|-3.60|<0.001
72609036|NCT00720278|144746773|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.376|STANDARD_DEVIATION|0.418||0.001||95.0|-2.2|-0.56|||ANCOVA|ANCOVA is being used due to a covariate being included in the model. The covariate is baseline TNSS score.||Change in baseline to Day 14||-0.56|-2.20|0.001
72609037|NCT00720278|144746773|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.432|STANDARD_DEVIATION|0.4145|<|0.001||95.0|-3.24|-1.62|||ANCOVA|ANCOVA is being used due to a covariate being included in the model. The covariate is baseline TNSS score.||Change in baseline to Day 14||-1.62|-3.24|<0.001
72609038|NCT00879190|144746788|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||||||1.0
72609039|NCT00879190|144746789|SUPERIORITY_OR_OTHER|||||||0.03|||||||Fisher Exact|||||||0.03
72609040|NCT00879190|144746790|SUPERIORITY_OR_OTHER|||||||0.6|||||||Fisher Exact|||||||0.6
72609041|NCT01248455|144746791|SUPERIORITY_OR_OTHER_LEGACY|||||||0.56|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||No patients obtained a 50% reduction in M-protein concentration and the study did not continue to the second stage of enrollment due to the lack of efficacy as defined by out criteria. This statistical analysis includes all participants (i.e., stable disease (SD), minimal response (MR), biochemical progression (BP), and progressive disease (PD)).||||0.56
72609042|NCT01178294|144746815|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||one-sided binomial exact test|||Summary statistics for the percentage of participants with serious bleeding episodes responsive at 24 hours after the initiation of treatment are presented, along with the 95% confidence interval (two-sided 95% Clopper-Pearson confidence interval).||||<0.001
72417738|NCT04333420|144345949|SUPERIORITY|||||||0.0407|||||||Log Rank|||Post-hoc analysis||||0.0407
72417739|NCT04333420|144345950|SUPERIORITY||Hazard Ratio (HR)|0.651||||0.6494|TWO_SIDED|95.0|0.103|4.135|||Regression, Cox|Covariate: Treatment (IFX-1 + BSC)||Cox proportional hazards regression model with outcome 28-day all-cause mortality (censored time to event variable with event = Death)||4.135|0.103|0.6494
72609043|NCT02089347|144746833|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is supported by a data if the lower bound of the two-sided 95% confidence interval (CI) is greater than -10%|Wilson score method|1.42|||||TWO_SIDED|95.0|-0.31|4.61||||||Non-inferiority comparison of post-booster response for Diphtheria.||4.61|-0.31|
72417740|NCT04333420|144345954|SUPERIORITY||Hazard Ratio (HR)|0.735||||0.0815|TWO_SIDED|95.0|0.519|1.039|||Regression, Cox|||Cox proportional hazards regression model with outcome 60-day all-cause mortality (censored time to event variable with event = Death); Covariate: Treatment (IFX-1 + SOC)||1.039|0.519|0.0815
72609044|NCT02089347|144746833|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is supported by the data if lower bound ot the two-sided 95% is greater than -10%|Wilson score method|6.25|||||TWO_SIDED|95.0|3.32|10.84||||||Non-inferiority comparison of post-vaccination booster response for tetanus||10.84|3.32|
72609045|NCT02089347|144746834|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is supported by a data if the lower bound of the two-sided 95% confidence interval (CI) is greater than -10%|Wilson score method|0.57|||||TWO_SIDED|95.0|-0.61|3.15||||||Non-inferiority comparison of Diphtheria post-vaccination seroprotection rates at ≥ 0.1 IU/mL||3.15|-0.61|
72609046|NCT02089347|144746834|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is supported by a data if the lower bound of the two-sided 95% confidence interval (CI) is greater than -10%.|Wilson score method|0.0|||||TWO_SIDED|95.0|-1.09|2.14||||||Non-inferiority comparison of Tetanus post-vaccination seroprotection rates at ≥ 0.1 IU/mL||2.14|-1.09|
72609047|NCT03176771|144746867|SUPERIORITY||Mean Difference (Final Values)|-3.6|STANDARD_ERROR_OF_MEAN|0.5|<|0.001|TWO_SIDED|95.0|-4.5|-2.6|||Mixed-effect Model Repeated Measures|||"Control for multiplicity was accomplished through the a fixed-sequence testing procedure for Week 6 outcomes:~* AIMS dyskinesia total score mean change from baseline (CFB): MT-5199 80 mg vs. placebo.~* AIMS: MT-5199 40 mg vs. PBO. For a test result in the above list to be considered statistically significant, all of the test results higher in the list must have been significant at the 0.05 level of significance."||-2.6|-4.5|<0.001
72417741|NCT04333420|144345955|SUPERIORITY||Risk Difference (RD)|7.352||||0.1553|TWO_SIDED|95.0|-2.762|17.465|||Regression, Logistic||Risk difference (IFX-1 - Placebo) of percentage of patients with an improvement in the 8-point ordinal scale; Risk difference and lower/upper limit of the CI are given in percent|At Day 15||17.465|-2.762|0.1553
72609048|NCT03176771|144746867|SUPERIORITY||Median Difference (Final Values)|-2.2|STANDARD_ERROR_OF_MEAN|0.4|<|0.001|TWO_SIDED|95.0|-3.0|-1.3|||Mixed-effect Model Repeated Measures|||||-1.3|-3.0|<0.001
72325591|NCT02317627|144174766|OTHER|No control group was used. Paired t-testing was used to determine the statistical significance of the mean change in Cohort 200 mg BID PASI from baseline to Week 12.||||||0.0035||||||Statistical significance was set at p ≤ 0.05. No adjustments for multiplicity were made. Missing data were not imputed.|t-test, 2 sided|||||||0.0035
72325592|NCT02317627|144174766|OTHER|No control group was used. Paired t-testing was used to determine the statistical significance of the mean change in Cohort 400 mg BID PASI from baseline to Week 12.||||||0.0261||||||Statistical significance was set at p ≤ 0.05. No adjustments for multiplicity were made. Missing data were not imputed.|t-test, 2 sided|||||||0.0261
72325593|NCT02317627|144174766|OTHER|No control group was used. Paired t-testing was used to determine the statistical significance of the mean change for all subjects' PASI from baseline to Week 12.|||||<|0.0001||||||Statistical significance was set at p ≤ 0.05. No adjustments for multiplicity were made. Missing data were not imputed.|t-test, 2 sided|||||||< 0.0001
72325594|NCT02317627|144174767|OTHER|No control group was used. Paired t-testing was used to determine the statistical significance of the mean change in Cohort 400 mg QD PASI from baseline to Week 12.||||||0.0282||||||Statistical significance was set at p ≤ 0.05. No adjustments for multiplicity were made. Missing data were not imputed.|t-test, 2 sided|||||||0.0282
72609049|NCT03176771|144746868|SUPERIORITY||Risk Difference (RD)|13.6||||0.027|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.027
72609050|NCT03176771|144746868|SUPERIORITY||Risk Difference (RD)|36.9|||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
72609051|NCT03176771|144746869|SUPERIORITY||Mean Difference (Final Values)|-1.5|STANDARD_ERROR_OF_MEAN|0.6||0.013|TWO_SIDED|95.0|-2.7|-0.3|||Mixed-effect Model Repeated Measures|||||-0.3|-2.7|0.013
72609052|NCT03176771|144746869|SUPERIORITY||Mean Difference (Final Values)|-2.3|STANDARD_ERROR_OF_MEAN|0.6|<|0.001|TWO_SIDED|95.0|-3.5|-1.1|||Mixed-effect Model Repeated Measures|||||-1.1|-3.5|<0.001
72609053|NCT03176771|144746870|SUPERIORITY||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.2||0.021|TWO_SIDED|95.0|-0.7|-0.1|||ANOVA|||||-0.1|-0.7|0.021
72609054|NCT03176771|144746870|SUPERIORITY||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|-1.0|-0.3|||ANOVA|||||-0.3|-1.0|<0.001
72609055|NCT00644059|144746886|SUPERIORITY_OR_OTHER||Vaccine Efficacy|81.36|||||TWO_SIDED|97.66|49.24|93.16|||Poisson Regression Model|||"Absolute vaccine efficacy (VE) was calculated as (1- the relative risk)100%. Relative Risk for virus-confirmed symptomatic influenza illness in the TIV-adj group vs. the non-flu control group. VE denotes the vaccine efficacy, i.e. 1-Itest/Inon-flu ctrl, where I stands for the population average incidence of influenza.~Absolute efficacy of TIV-adj is at most 40% (i.e. the probability of an influenza in the test group relative to that in the non-flu vaccine group is at least 0.6)"||93.16|49.24|
72609056|NCT00644059|144746889|SUPERIORITY_OR_OTHER||Vaccine Efficacy|81.36|||||TWO_SIDED|95.0|49.24|93.16|||Poisson Regression Model|||"Absolute vaccine efficacy (VE) was calculated as (1- the relative risk)100%. Relative Risk for virus-confirmed symptomatic influenza illness in the TIV-adj group vs. the non-flu control group. VE denotes the vaccine efficacy, i.e. 1-Itest/Inon-flu ctrl, where I stands for the incidence of influenza.~Absolute efficacy of TIV-adj is at most 40% (i.e. the probability of an influenza in the test group relative to that in the non-flu vaccine group is at least 0.6)"||93.16|49.24|
72609057|NCT00644059|144746889|SUPERIORITY_OR_OTHER||Vaccine Efficacy|95.5|||||TWO_SIDED|95.0|80.92|98.94|||Poisson Regression Model|||"Absolute vaccine efficacy (VE) was calculated as (1- the relative risk)100%. Relative Risk for virus-confirmed symptomatic influenza illness in the TIV-adj group vs. the non-flu control group. VE denotes the vaccine efficacy, i.e. 1-Itest/Inon-flu ctrl, where I stands for the incidence of influenza.~Absolute efficacy of TIV-adj is at most 40% (i.e. the probability of an influenza in the test group relative to that in the non-flu vaccine group is at least 0.6)"||98.94|80.92|
72609058|NCT00644059|144746889|SUPERIORITY_OR_OTHER||Vaccine Efficacy|0.32|||||TWO_SIDED|95.0|0.13|0.73|||Mantel Haenszel|||Relative efficacy for TIV-adj was to be calculated as VE = (1-Itest/Ictrl)100%, where I is the incidence of influenza, i.e. percentage of subjects with virus-confirmed symptomatic influenza A or B illness, in the investigational agent (TIV-adj) group or in the flu vaccine control group.||0.73|0.13|
72609059|NCT00644059|144746889|SUPERIORITY_OR_OTHER||Vaccine Efficacy|0.09|||||TWO_SIDED|95.0|0.02|0.38|||Mantel Haenszel|||Relative efficacy for TIV-adj was to be calculated as VE = (1-Itest/Ictrl)100%, where I is the incidence of influenza, i.e. percentage of subjects with virus-confirmed symptomatic influenza A or B illness, in the investigational agent (TIV-adj) group or in the flu vaccine control group.||0.38|0.02|
72609060|NCT00644059|144746890|SUPERIORITY_OR_OTHER||vaccine Efficacy|79.18|||||TWO_SIDED|95.0|54.78|90.42|||Poisson Regression Model|||"Absolute vaccine efficacy (VE) was calculated as (1- the relative risk)100%. Relative Risk for virus-confirmed symptomatic influenza illness in the TIV-adj group vs. the non-flu control group. VE denotes the vaccine efficacy, i.e. 1-Itest/Inon-flu ctrl, where I stands for the population average incidence of influenza.~Absolute efficacy of TIV-adj is at most 40% (i.e. the probability of an influenza in the test group relative to that in the non-flu vaccine group is at least 0.6)"||90.42|54.78|
72609061|NCT00644059|144746890|SUPERIORITY_OR_OTHER||Vaccine Efficacy|92.1|||||TWO_SIDED|95.0|77.35|97.24|||Poisson Regression Model|||Absolute vaccine efficacy (VE) was calculated as (1- the relative risk)100%. Relative Risk for virus-confirmed symptomatic influenza illness in the TIV-adj group vs. the non-flu control group. VE denotes the vaccine efficacy, i.e. 1-Itest/Inon-flu ctrl, where I stands for the incidence of influenza. Absolute efficacy of TIV-adj is at most 40% (i.e. the probability of an influenza in the test group relative to that in the non-flu vaccine group is at least 0.6)||97.24|77.35|
72609062|NCT00644059|144746890|SUPERIORITY_OR_OTHER||Vaccine Efficacy|64.16|||||TWO_SIDED|95.0|23.21|83.28|||Poisson Regression Model|||Relative efficacy for TIV-adj was to be calculated as VE = (1-Itest/Ictrl)100%, where I is the incidence of influenza, i.e. percentage of subjects with virus-confirmed symptomatic influenza A or B illness, in the investigational agent (TIV-adj) group or in the flu vaccine control group.||83.28|23.21|
72609063|NCT00644059|144746890|SUPERIORITY_OR_OTHER||Vaccine Efficacy|85.66|||||TWO_SIDED|95.0|58.95|94.99|||Poisson Regression Model|||Relative efficacy for TIV-adj was to be calculated as VE = (1-Itest/Ictrl)100%, where I is the incidence of influenza, i.e. percentage of subjects with virus-confirmed symptomatic influenza A or B illness, in the investigational agent (TIV-adj) group or in the flu vaccine control group.||94.99|58.95|
72609064|NCT00644059|144746896|SUPERIORITY_OR_OTHER||GMT[A/Brisbane/2007 (A/H1N1)]|0.83|||||TWO_SIDED|95.0|0.67|1.02|||ANOVA|||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 1 for strain A/Brisbane/2007 (A/H1N1) in terms of GMTs in subjects aged 6 to \<36 months by HI assay.||1.02|0.67|
72325595|NCT02317627|144174767|OTHER|No control group was used. Paired t-testing was used to determine the statistical significance of the mean change in Cohort 200 mg BID PASI from baseline to Week 12.||||||0.0029||||||Statistical significance was set at p ≤ 0.05. No adjustments for multiplicity were made. Missing data were not imputed.|t-test, 2 sided|||||||0.0029
72609065|NCT00644059|144746896|SUPERIORITY_OR_OTHER||GMT[A/Brisbane/2007 (A/H1N1)]|7.63|||||TWO_SIDED|95.0|5.42|11.0|||ANOVA|||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 29 for strain A/Brisbane/2007 (A/H1N1) in terms of GMTs in subjects aged 6 to \<36 months by HI assay.||11|5.42|
72325596|NCT02317627|144174767|OTHER|No control group was used. Paired t-testing was used to determine the statistical significance of the mean change in Cohort 400 mg BID PASI from baseline to Week 12.||||||0.0703||||||Statistical significance was set at p ≤ 0.05. No adjustments for multiplicity were made. Missing data were not imputed.|t-test, 2 sided|||||||0.0703
72325597|NCT02317627|144174767|OTHER|No control group was used. Paired t-testing was used to determine the statistical significance of the mean change of all subjects' PASI from baseline to Week 12.||||||0.0002||||||Statistical significance was set at p ≤ 0.05. No adjustments for multiplicity were made. Missing data were not imputed.|t-test, 2 sided|||||||0.0002
72609066|NCT00644059|144746896|SUPERIORITY_OR_OTHER||GMT[A/Brisbane/2007 (A/H1N1)]|15.0|||||TWO_SIDED|95.0|11.0|21.0|||ANOVA|||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 50 for strain A/Brisbane/2007 (A/H1N1) in terms of GMTs in subjects aged 6 to \<36 months by HI assay||21|11|
72325598|NCT02317627|144174772|OTHER|No control group was used. Paired t-testing was used to determine the statistical significance of the mean change in Cohort 400 mg QD from baseline to Week 4.||||||0.0064||||||Statistical significance was set at p ≤ 0.05. No adjustments for multiplicity were made. Missing data were not imputed.|t-test, 2 sided|||||||0.0064
72417742|NCT04333420|144345955|SUPERIORITY||Risk Difference (RD)|8.078||||0.1181|TWO_SIDED|95.0|-1.968|18.125|||Regression, Logistic||Risk difference (IFX-1 - Placebo) of percentage of patients with an improvement in the 8-point ordinal scale; Risk difference and lower/upper limit of the CI are given in percent|At Day 28||18.125|-1.968|0.1181
72417743|NCT04333420|144345956|SUPERIORITY||Risk Difference (RD)|-2.081||||0.4105|TWO_SIDED|95.0|-6.949|2.787|||Regression, Logistic||Risk difference (IFX-1 - Placebo) of percentage of patients developing acute kidney failure; Risk difference and lower/upper limit of the CI are given in percent|||2.787|-6.949|0.4105
72417744|NCT04333420|144345957|SUPERIORITY||Hazard Ratio (HR)|0.539||||0.0422|TWO_SIDED|95.0|0.297|0.978||p-value refers to hazard ratio from cause-specific Cox proportional hazards model for first renal replacement therapy.|Regression, Cox|Covariate: Treatment (IFX-1 + SOC)||||0.978|0.297|0.0422
72417745|NCT04179175|144345958|OTHER||Hazard Ratio (HR)|0.87||||0.25|TWO_SIDED|95.0|0.59|1.29|||Log Rank|one-sided stratified log-rank test, with region and body weight (\<90 kg, ≥ 90 kg) as strata||||1.29|0.59|0.250
72417746|NCT04179175|144345958|OTHER||Hazard Ratio (HR)|0.7||||0.044|TWO_SIDED|95.0|0.47|1.05|||Log Rank|one-sided stratified log-rank test, with region and body weight (\<90 kg, ≥ 90 kg) as strata||||1.05|0.47|0.044
72417747|NCT03014674|144345967|EQUIVALENCE|Interpretation of the comparability of the autoinjector and safety syringe with the reconstituted lyophilized drug product was guided by a two-sided 90% confidence interval (CI) for the ratio of the geometric mean of test treatment to reference treatment in the range (0.80, 1.25) for Cmax.|Ratio|1.04|||||TWO_SIDED|90.0|0.98|1.11|||||Ratio (autoinjector/lyophilized drug) for Cmax has been presented|||1.11|0.98|
72417748|NCT03014674|144345967|EQUIVALENCE|Interpretation of the comparability of the autoinjector and safety syringe with the reconstituted lyophilized drug product was guided by a two-sided 90% CI for the ratio of the geometric mean of test treatment to reference treatment in the range (0.80, 1.25) for Cmax.|Ratio|1.06|||||TWO_SIDED|90.0|0.99|1.12|||||Ratio (safety syringe/lyophilized drug) for Cmax has been presented|||1.12|0.99|
72417749|NCT03014674|144345968|EQUIVALENCE|Interpretation of the comparability of the autoinjector and safety syringe with the reconstituted lyophilized drug product was guided by a two-sided 90% CI for the ratio of the geometric mean of test treatment to reference treatment in the range (0.80, 1.25) for AUC (0-t)|Ratio|1.08|||||TWO_SIDED|90.0|1.01|1.15|||||Ratio (autoinjector/lyophilized drug) for AUC(0-t) has been presented|||1.15|1.01|
72417750|NCT03014674|144345968|EQUIVALENCE|Interpretation of the comparability of the autoinjector and safety syringe with the reconstituted lyophilized drug product was guided by a two-sided 90% CI for the ratio of the geometric mean of test treatment to reference treatment in the range (0.80, 1.25) for AUC (0-t).|Ratio|1.04|||||TWO_SIDED|90.0|0.97|1.12|||||Ratio (safety syringe/lyophilized drug) for AUC(0-t) has been presented|||1.12|0.97|
72417751|NCT03014674|144345968|EQUIVALENCE|Interpretation of the comparability of the autoinjector and safety syringe with the reconstituted lyophilized drug product was guided by a two-sided 90% CI for the ratio of the geometric mean of test treatment to reference treatment in the range (0.80, 1.25) for AUC (0-inf).|Ratio|1.07|||||TWO_SIDED|90.0|1.0|1.13|||||Ratio (autoinjector/lyophilized drug) for AUC(0-inf) has been presented|||1.13|1.00|
72417752|NCT03014674|144345968|EQUIVALENCE|Interpretation of the comparability of the autoinjector and safety syringe with the reconstituted lyophilized drug product was guided by a two-sided 90% CI for the ratio of the geometric mean of test treatment to reference treatment in the range (0.80, 1.25) for AUC (0-inf).|Ratio|1.02|||||TWO_SIDED|90.0|0.95|1.09|||||Ratio (safety syringe/lyophilized drug) for AUC(0-inf) has been presented|||1.09|0.95|
72609067|NCT00644059|144746896|SUPERIORITY_OR_OTHER||GMT[A/Brisbane/2007 (A/H1N1)]|6.48|||||TWO_SIDED|95.0|4.83|8.68|||ANOVA|||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 181 for strain A/Brisbane/2007 (A/H1N1) in terms of GMTs in subjects aged 6 to \<36 months by HI assay||8.68|4.83|
72609068|NCT00644059|144746896|SUPERIORITY_OR_OTHER||GMT[A/Brisbane/2007 (A/H3N2)]|1.01|||||TWO_SIDED|95.0|0.85|1.21|||ANOVA|||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 1 for strain A/Brisbane/2007 (A/H3N2) in terms of GMTs in subjects aged 6 to \<36 months by HI assay.||1.21|0.85|
72609069|NCT00644059|144746896|SUPERIORITY_OR_OTHER||GMT[A/Brisbane/2007 (A/H3N2)]|9.82|||||TWO_SIDED|95.0|7.76|12.0|||ANOVA|||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 29 for strain A/Brisbane/2007 (A/H3N2) in terms of GMTs in subjects aged 6 to \<36 months by HI assay.||12|7.76|
72609070|NCT00644059|144746896|SUPERIORITY_OR_OTHER||GMT[A/Brisbane/2007 (A/H3N2)]|16.0|||||TWO_SIDED|95.0|12.0|20.0|||ANOVA|||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 50 for strain A/Brisbane/2007 (A/H3N2) in terms of GMTs in subjects aged 6 to \<36 months by HI assay.||20|12|
72609071|NCT00644059|144746896|SUPERIORITY_OR_OTHER||GMT[A/Brisbane/2007 (A/H3N2)]|4.92|||||TWO_SIDED|95.0|3.64|6.65|||ANOVA|||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 181 for strain A/Brisbane/2007 (A/H3N2) in terms of GMTs in subjects aged 6 to \<36 months by HI assay.||6.65|3.64|
72325599|NCT02317627|144174772|OTHER|No control group was used. Paired t-testing was used to determine the statistical significance of the mean change in Cohort 200 mg BID from baseline to Week 4.||||||0.0479||||||Statistical significance was set at p ≤ 0.05. No adjustments for multiplicity were made. Missing data were not imputed.|t-test, 2 sided|||||||0.0479
72417753|NCT00833560|144346035|SUPERIORITY_OR_OTHER||Percentage of participants with response|85.4|||<|0.0001|TWO_SIDED|95.0|81.5|88.8|||Two - sided binomial test|||||88.8|81.5|<0.0001
72417754|NCT00833560|144346036|SUPERIORITY_OR_OTHER||Percentage of participants with response|87.7|||<|0.0001|TWO_SIDED|95.0|83.6|91.0|||Two-sided binomial test|||||91.0|83.6|<0.0001
72417755|NCT00184548|144346054|SUPERIORITY_OR_OTHER|||||||0.934||||||Two-sided significance level 5%|Regression, Logistic|||Test for Odds ratio=1, corresponding to a null hypothesis of no difference in mortality for patients who died between groups for Blunt Trauma. Odds-ratio is adjusted for baseline covariates: Age, Injury Severity Score (ISS), Glasgow Coma -Scale Score (GCS), International Normalized Ratio (INR) and acute lung injury (P/F \> 200). Missing covariates are imputed by the mean value.||||0.934
72325600|NCT02317627|144174772|OTHER|No control group was used. Paired t-testing was used to determine the statistical significance of the mean change in Cohort 400 mg BID from baseline to Week 4.||||||0.1513||||||Statistical significance was set at p ≤ 0.05. No adjustments for multiplicity were made. Missing data were not imputed.|t-test, 2 sided|||||||0.1513
72417756|NCT00184548|144346054|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.18||||0.589||95.0|0.64|2.17||Two-sided significance level 5%|Cox Proportional Hazards Model|||Treatment groups are compared using a Cox Proportional Hazards model with treatment as factor and adjusting for age, Injury Severity Score (ISS), Glasgow Coma -Scale Score(GCS), International Normalized Ratio (INR) and acute lung injury.||2.17|0.64|0.589
72417757|NCT00184548|144346056|SUPERIORITY_OR_OTHER||LS means|0.9||||0.308||95.0|-0.83|2.63|||ANCOVA|||Baseline covariates: Age, Injury Severity Score (ISS), Glasgow Coma -Scale Score (GCS), International Normalized Ratio (INR) and acute lung injury.||2.63|-0.83|0.308
72325601|NCT02317627|144174772|OTHER|No control group was used. Paired t-testing was used to determine the statistical significance of the mean change Overall from baseline to Week 4.||||||0.0002||||||Statistical significance was set at p ≤ 0.05. No adjustments for multiplicity were made. Missing data were not imputed.|t-test, 2 sided|||||||0.0002
72417758|NCT00184548|144346058|SUPERIORITY_OR_OTHER||Hodges-Lehmann shift estimate|1.0||||0.038||95.0|0.0|2.0|||Wilcoxon (Mann-Whitney)|||||2|0|0.038
72325602|NCT02317627|144174773|OTHER|No control group was used. Paired t-testing was used to determine the statistical significance of the mean change in Cohort 400 mg QD from baseline to Week 8.||||||0.0137||||||Statistical significance was set at p ≤ 0.05. No adjustments for multiplicity were made. Missing data were not imputed.|t-test, 2 sided|||||||0.0137
72417759|NCT00184548|144346059|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.175||||0.384||95.0|0.817|1.69|||Regression, Logistic|||||1.690|0.817|0.384
72417760|NCT00184548|144346060|SUPERIORITY_OR_OTHER||Hodges-Lehmann shift estimate|2.0||||0.03||95.0|0.0|4.0|||Wilcoxon (Mann-Whitney)|||||4|0|0.030
72417761|NCT02184611|144346065|OTHER||Least square mean difference|0.154|||<|0.001|TWO_SIDED|95.0|0.113|0.194||Analysis was performed using a MMRM model with covariates of treatment, Baseline, smoking status, country, Day, Day by Baseline and Day by treatment interactions.|Mixed Models Repeated Measures (MMRM)|||UMEC versus Placebo.||0.194|0.113|<0.001
72325603|NCT02317627|144174773|OTHER|No control group was used. Paired t-testing was used to determine the statistical significance of the mean change in Cohort 200 mg BID from baseline to Week 8.||||||0.0017||||||Statistical significance was set at p ≤ 0.05. No adjustments for multiplicity were made. Missing data were not imputed.|t-test, 2 sided|||||||0.0017
72417762|NCT02184611|144346066|OTHER||Least square Mean difference|0.9||||0.004|TWO_SIDED|95.0|0.3|1.5||Analysis performed using a MMRM model with covariates of treatment, BDI focal score, smoking status, country, Day, Day by BDI focal score and Day by treatment interactions.|MMRM|||UMEC versus Placebo.||1.5|0.3|0.004
72417763|NCT02184611|144346067|OTHER||Least square Mean difference|0.125|||<|0.001|TWO_SIDED|95.0|0.103|0.147||Analysis performed using an analysis of covariance (ANCOVA) model with covariates of treatment, baseline (mean of the two assessments made 30 min and 5 min pre-dose on Day 1), smoking status and country.|ANCOVA|||UMEC versus Placebo.||0.147|0.103|<0.001
72325604|NCT02317627|144174773|OTHER|No control group was used. Paired t-testing was used to determine the statistical significance of the mean change in Cohort 400 mg BID from baseline to Week 8.||||||0.0743||||||Statistical significance was set at p ≤ 0.05. No adjustments for multiplicity were made. Missing data were not imputed.|t-test, 2 sided|||||||0.0743
72417764|NCT02184611|144346076|OTHER||Least sqaure mean difference|-4.39||||0.002|TWO_SIDED|95.0|-7.21|-1.58||Analysis performed using a repeated measures model with covariates of treatment, Baseline (score prior to dosing on Day 1), smoking status, country, Day, Day by Baseline and Day by treatment interactions.|MMRM|||Day 28, UMEC Vs Placebo.||-1.58|-7.21|0.002
72325605|NCT02317627|144174773|OTHER|No control group was used. Paired t-testing was used to determine the statistical significance of the mean change Overall from baseline to Week 8.|||||<|0.0001||||||Statistical significance was set at p ≤ 0.05. No adjustments for multiplicity were made. Missing data were not imputed.|t-test, 2 sided|||||||< 0.0001
72325606|NCT02317627|144174774|OTHER|No control group was used. Paired t-testing was used to determine the statistical significance of the mean change in Cohort 400 mg QD from baseline to 4 weeks.||||||0.014||||||Statistical significance was set at p ≤ 0.05. No adjustments for multiplicity were made. Missing data were not imputed.|t-test, 2 sided|||||||0.0140
72325607|NCT02317627|144174774|OTHER|No control group was used. Paired t-testing was used to determine the statistical significance of the mean change in Cohort 200 mg BID from baseline to 4 weeks.||||||0.062||||||Statistical significance was set at p ≤ 0.05. No adjustments for multiplicity were made. Missing data were not imputed.|t-test, 2 sided|||||||0.0620
72325608|NCT02317627|144174774|OTHER|No control group was used. Paired t-testing was used to determine the statistical significance of the mean change in 400 mg BID from baseline to 4 weeks.||||||0.262||||||Statistical significance was set at p ≤ 0.05. No adjustments for multiplicity were made. Missing data were not imputed.|t-test, 2 sided|||||||0.2620
72325609|NCT02317627|144174774|OTHER|No control group was used. Paired t-testing was used to determine the statistical significance of the mean change of all subjects from baseline to 4 weeks.||||||0.0008||||||Statistical significance was set at p ≤ 0.05. No adjustments for multiplicity were made. Missing data were not imputed.|t-test, 2 sided|||||||0.0008
72325610|NCT02317627|144174774|OTHER|No control group was used. Paired t-testing was used to determine the statistical significance of the mean change in Cohort 400 mg QD from baseline to 8 weeks.||||||0.0137||||||Statistical significance was set at p ≤ 0.05. No adjustments for multiplicity were made. Missing data were not imputed.|t-test, 2 sided|||||||0.0137
72325611|NCT02317627|144174774|OTHER|No control group was used. Paired t-testing was used to determine the statistical significance of the mean change in Cohort 200 mg BID from baseline to 8 weeks.||||||0.0064||||||Statistical significance was set at p ≤ 0.05. No adjustments for multiplicity were made. Missing data were not imputed.|t-test, 2 sided|||||||0.0064
72417765|NCT02184611|144346076|OTHER||Least square mean difference|-4.59||||0.003|TWO_SIDED|95.0|-7.61|-1.57||Analysis performed using a repeated measures model with covariates of treatment, Baseline (score prior to dosing on Day 1), smoking status, country, Day, Day by Baseline and Day by treatment interactions.|MMRM|||Day 84, UMEC Vs Placebo.||-1.57|-7.61|0.003
72417766|NCT02184611|144346076|OTHER||Least sqaure mean difference|-3.03||||0.058|TWO_SIDED|95.0|-6.15|0.1||Analysis performed using a repeated measures model with covariates of treatment, Baseline (score prior to dosing on Day 1), smoking status, country, Day, Day by Baseline and Day by treatment interactions.|MMRM|||Day 168, UMEC Vs Placebo.||0.10|-6.15|0.058
72417767|NCT02184611|144346077|OTHER||Least sqaure mean difference|-1.49||||0.027|TWO_SIDED|95.0|-2.81|-0.17||Analysis performed using a repeated measures model with covariates of treatment, Baseline (score prior to dosing on Day 1), smoking status, country, Day, Day by Baseline and Day by treatment interactions.|MMRM|||Day 28, UMEC Vs Placebo.||-0.17|-2.81|0.027
72417768|NCT02184611|144346077|OTHER||Least square mean difference|-2.1||||0.004|TWO_SIDED|95.0|-3.51|-0.68||Analysis performed using a repeated measures model with covariates of treatment, Baseline (score prior to dosing on Day 1), smoking status, country, Day, Day by Baseline and Day by treatment interactions.|MMRM|||Day 84, UMEC Vs Placebo.||-0.68|-3.51|0.004
72417769|NCT02184611|144346077|OTHER||Least square mean difference|-0.68||||0.386|TWO_SIDED|95.0|-2.22|0.86||Analysis performed using a repeated measures model with covariates of treatment, Baseline (score prior to dosing on Day 1), smoking status, country, Day, Day by Baseline and Day by treatment interactions.|MMRM|||Day 128, UMEC Vs Placebo.||0.86|-2.22|0.386
72417770|NCT00985725|144346084|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-8.0||||0.0009|TWO_SIDED|95.0|-12.7|-3.3|||ANCOVA|||||-3.3|-12.7|0.0009
72417771|NCT00985725|144346085|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.9||||0.0465|TWO_SIDED|95.0|-3.7|0.0|||ANCOVA|||||0.0|-3.7|0.0465
72417772|NCT00985725|144346086|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.1||||0.0181|TWO_SIDED|95.0|-9.4|-0.9|||ANCOVA|||Behavioral recognition index||-0.9|-9.4|0.0181
72325612|NCT02317627|144174774|OTHER|No control group was used. Paired t-testing was used to determine the statistical significance of the mean change in Cohort 400 mg BID from baseline to 8 weeks.||||||0.0743||||||Statistical significance was set at p ≤ 0.05. No adjustments for multiplicity were made. Missing data were not imputed.|t-test, 2 sided|||||||0.0743
72325613|NCT02317627|144174774|OTHER|No control group was used. Paired t-testing was used to determine the statistical significance of the mean change of all subjects from baseline to 8 weeks.|||||<|0.0001||||||Statistical significance was set at p ≤ 0.05. No adjustments for multiplicity were made. Missing data were not imputed.|t-test, 2 sided|||||||< 0.0001
72325614|NCT02317627|144174779|OTHER|No control group was used. Paired t-testing was used to determine the statistical significance of the mean change in Cohort 400 mg QD from baseline to 12 weeks.||||||0.004||||||Statistical significance was set at p ≤ 0.05. No adjustments for multiplicity were made. Missing data were not imputed.|t-test, 2 sided|||||||0.004
72325615|NCT02317627|144174779|OTHER|No control group was used. Paired t-testing was used to determine the statistical significance of the mean change in Cohort 200 mg BID from baseline to 12 weeks.||||||0.007||||||Statistical significance was set at p ≤ 0.05. No adjustments for multiplicity were made. Missing data were not imputed.|t-test, 2 sided|||||||0.007
72325616|NCT02317627|144174779|OTHER|No control group was used. Paired t-testing was used to determine the statistical significance of the mean change in Cohort 400 mg BID from baseline to 12 weeks.||||||0.09||||||Statistical significance was set at p ≤ 0.05. No adjustments for multiplicity were made. Missing data were not imputed.|t-test, 2 sided|||||||0.090
72325617|NCT02317627|144174779|OTHER|No control group was used. Paired t-testing was used to determine the statistical significance of the mean change Overall from baseline to 12 weeks.|||||<|0.001||||||Statistical significance was set at p ≤ 0.05. No adjustments for multiplicity were made. Missing data were not imputed.|t-test, 2 sided|||||||< 0.001
72325618|NCT02317627|144174780|SUPERIORITY|||||||0.004||||||Statistical significance was set at p ≤ 0.05. No adjustments for multiplicity were made. Missing data were not imputed.|t-test, 2 sided|||||||0.004
72417773|NCT00985725|144346086|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.2||||0.0204|TWO_SIDED|95.0|-7.7|-0.7|||ANCOVA|||Inhibit subscale||-0.7|-7.7|0.0204
72609072|NCT00644059|144746896|SUPERIORITY_OR_OTHER||GMT[B/Florida/2006]|1.0|||||TWO_SIDED|95.0|0.91|1.1|||ANOVA|||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 1 for strain B/Florida/2006 in terms of GMTs in subjects aged 6 to \<36 months by HI assay.||1.1|0.91|
72609073|NCT00644059|144746896|SUPERIORITY_OR_OTHER||GMT[B/Florida/2006]|1.5|||||TWO_SIDED|95.0|1.19|1.9|||ANOVA|||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 29 for strain B/Florida/2006 in terms of GMTs in subjects aged 6 to \<36 months by HI assay.||1.9|1.19|
72609074|NCT00644059|144746896|SUPERIORITY_OR_OTHER||GMT[B/Florida/2006]|6.99|||||TWO_SIDED|95.0|5.72|8.53|||ANOVA|||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 50 for strain B/Florida/2006 in terms of GMTs in subjects aged 6 to \<36 months by HI assay.||8.53|5.72|
72609075|NCT00644059|144746896|SUPERIORITY_OR_OTHER||GMT[B/Florida/2006]|2.92|||||TWO_SIDED|95.0|2.44|3.5|||ANOVA|||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 181 for strain B/Florida/2006 in terms of GMTs in subjects aged 6 to \<36 months by HI assay.||3.5|2.44|
72609076|NCT00644059|144746896|SUPERIORITY_OR_OTHER||GMT [A/Solomon Islands/2006 (A/H1N1)]|0.81|||||TWO_SIDED|95.0|0.64|1.04|||ANOVA|||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 1 for strain A/Solomon Islands/2006 (A/H1N1) in terms of GMTs in subjects aged 6 to \<36 months by HI assay.||1.04|0.64|
72609077|NCT00644059|144746896|SUPERIORITY_OR_OTHER||GMT[A/Solomon Islands/2006 (A/H1N1)]|1.21|||||TWO_SIDED|95.0|0.83|1.78|||ANOVA|||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 29 for strain A/Solomon Islands/2006 (A/H1N1) in terms of GMTs in subjects aged 6 to \<36 months by HI assay.||1.78|0.83|
72609078|NCT00644059|144746896|SUPERIORITY_OR_OTHER||GMT [A/Solomon Islands/2006 (A/H1N1]|7.54|||||TWO_SIDED|95.0|5.33|11.0|||ANOVA|||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 50 for strain A/Solomon Islands/2006 (A/H1N1) in terms of GMTs in subjects aged 6 to \<36 months by HI assay.||11|5.33|
72609079|NCT00644059|144746896|SUPERIORITY_OR_OTHER||GMT[A/Solomon Islands/2006 (A/H1N1)]|3.31|||||TWO_SIDED|95.0|2.4|4.55|||ANOVA|||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 181 for strain A/Solomon Islands/2006 (A/H1N1) in terms of GMTs in subjects aged 6 to \<36 months by HI assay.||4.55|2.4|
72609080|NCT00644059|144746896|SUPERIORITY_OR_OTHER||GMT [A/Wisconsin/2009 (A/H3N2)]|0.9|||||TWO_SIDED|95.0|0.74|1.1|||ANOVA|||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 1 for strain A/Wisconsin/2009 (A/H3N2) in terms of GMTs in subjects aged 6 to \<36 months by HI assay.||1.1|0.74|
72609081|NCT00644059|144746896|SUPERIORITY_OR_OTHER||GMT[A/Wisconsin/2009 (A/H3N2)]|3.54|||||TWO_SIDED|95.0|2.78|4.51|||GMT|||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 29 for strain A/Wisconsin/2009 (A/H3N2) in terms of GMTs in subjects aged 6 to \<36 months by HI assay.||4.51|2.78|
72609082|NCT00644059|144746896|SUPERIORITY_OR_OTHER||GMT [A/Wisconsin/2009 (A/H3N2)]|13.0|||||TWO_SIDED|95.0|10.0|16.0|||ANOVA|||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 50 for strain A/Wisconsin/2009 (A/H3N2) in terms of GMTs in subjects aged 6 to \<36 months by HI assay.||16|10|
72609083|NCT00644059|144746896|SUPERIORITY_OR_OTHER||GMT [A/Wisconsin/2009 (A/H3N2)]|3.6|||||TWO_SIDED|95.0|2.61|4.95|||ANOVA|||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 181 for strain A/Wisconsin/2009 (A/H3N2) in terms of GMTs in subjects aged 6 to \<36 months by HI assay.||4.95|2.61|
72609084|NCT00644059|144746896|SUPERIORITY_OR_OTHER||GMT [B/Brisbane/2008]|1.0|||||TWO_SIDED|95.0|1.0|1.0|||ANOVA|||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 1 for strain B/Brisbane/2008 in terms of GMTs in subjects aged 6 to \<36 months by HI assay.||1|1|
72325619|NCT02317627|144174780|SUPERIORITY|||||||0.029||||||Statistical significance was set at p ≤ 0.05. No adjustments for multiplicity were made. Missing data were not imputed.|t-test, 2 sided|||||||0.029
72609085|NCT00644059|144746896|SUPERIORITY_OR_OTHER||GMT [B/Brisbane/2008]|1.06|||||TWO_SIDED|95.0|1.02|1.11|||ANOVA|||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 29 for strain B/Brisbane/2008 in terms of GMTs in subjects aged 6 to \<36 months by HI assay.||1.11|1.02|
72609086|NCT00644059|144746896|SUPERIORITY_OR_OTHER||GMT [B/Brisbane/2008]|1.74|||||TWO_SIDED|95.0|1.57|1.92|||ANOVA|||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 50 for strain B/Brisbane/2008 in terms of GMTs in subjects aged 6 to \<36 months by HI assay.||1.92|1.57|
72609087|NCT00644059|144746896|SUPERIORITY_OR_OTHER||GMT [B/Brisbane/2008]|1.0|||||TWO_SIDED|95.0|0.92|1.08|||ANOVA|||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 181 for strain B/Brisbane/2008 in terms of GMTs in subjects aged 6 to \<36 months by HI assay.||1.08|0.92|
72609088|NCT00644059|144746899|SUPERIORITY_OR_OTHER||GMT [A/Brisbane/2007 (A/H1N1)]|0.96|||||TWO_SIDED|95.0|0.78|1.19|||ANOVA|||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 1 for strain A/Brisbane/2007 (A/H1N1) in terms of GMTs in subjects aged 6 to \<72 months by HI assay.||1.19|0.78|
72609089|NCT00644059|144746899|SUPERIORITY_OR_OTHER||GMT [A/Brisbane/2007 (A/H1N1)]|6.41|||||TWO_SIDED|95.0|4.69|8.76|||ANOVA|||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 29 for strain A/Brisbane/2007 (A/H1N1) in terms of GMTs in subjects aged 6 to \<72 months by HI assay.||8.76|4.69|
72609090|NCT00644059|144746899|SUPERIORITY_OR_OTHER||GMT [A/Brisbane/2007 (A/H1N1)]|8.26|||||TWO_SIDED|95.0|6.36|11.0|||ANOVA|||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 50 for strain A/Brisbane/2007 (A/H1N1) in terms of GMTs in subjects aged 6 to \<72 months by HI assay.||11|6.36|
72609091|NCT00644059|144746899|SUPERIORITY_OR_OTHER||GMT [A/Brisbane/2007 (A/H1N1)]|4.37|||||TWO_SIDED|95.0|3.38|5.65|||ANOVA|||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 181 for strain A/Brisbane/2007 (A/H1N1) in terms of GMTs in subjects aged 6 to \<72 months by HI assay.||5.65|3.38|
72325620|NCT02317627|144174780|SUPERIORITY|||||||0.084||||||Statistical significance was set at p ≤ 0.05. No adjustments for multiplicity were made. Missing data were not imputed.|t-test, 2 sided|||||||0.084
72325621|NCT02317627|144174780|SUPERIORITY||||||<|0.001||||||Statistical significance was set at p ≤ 0.05. No adjustments for multiplicity were made. Missing data were not imputed.|t-test, 2 sided|||||||< 0.001
72325622|NCT03384875|144174802|SUPERIORITY||Risk Difference (RD)|0.0||||0.517|TWO_SIDED||||||Chi-squared|||||||0.517
72325623|NCT00896012|144174809|OTHER|||||||0.222||||||Significance was considered to be P \< .05|t-test, 2 sided|||Statistical analysis was performed by analysis of variance and Student t test for estimated glomerular filtration rate (eGFR) at 12 months. Chi-square analysis was used for demographics data.||||0.222
72325624|NCT02735421|144174811|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
72325625|NCT00939107|144174823|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.5|||>|0.05||95.0|0.2|2.8|||t-test, 2 sided|||||2.8|0.2|>0.05
72609092|NCT00644059|144746899|SUPERIORITY_OR_OTHER||GMT [A/Brisbane/2007 (A/H3N2)]|1.05|||||TWO_SIDED|95.0|0.82|1.35|||ANOVA|||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 1 for strain A/Brisbane/2007 (A/H3N2) in terms of Geometric Mean Titers GMTs in subjects aged 6 to \<72 months by HI assay.||1.35|0.82|
72609093|NCT00644059|144746899|SUPERIORITY_OR_OTHER||GMT [A/Brisbane/2007 (A/H3N2)]|6.42|||||TWO_SIDED|95.0|4.72|8.73|||ANOVA|||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 29 for strain A/Brisbane/2007 (A/H3N2) in terms of GMTs in subjects aged 6 to \<72 months by HI assay.||8.73|4.72|
72609094|NCT00644059|144746899|SUPERIORITY_OR_OTHER||GMT [A/Brisbane/2007 (A/H3N2)]|7.98|||||TWO_SIDED|95.0|6.2|10.0|||ANOVA|||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 50 for strain A/Brisbane/2007 (A/H3N2) in terms of GMTs in subjects aged 6 to \<72 months by HI assay.||10|6.2|
72609095|NCT00644059|144746899|SUPERIORITY_OR_OTHER||GMT [A/Brisbane/2007 (A/H3N2)]|3.13|||||TWO_SIDED|95.0|2.42|4.05|||ANOVA|||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 181 for strain A/Brisbane/2007 (A/H3N2) in terms of GMTs in subjects aged 6 to \<72 months by HI assay.||4.05|2.42|
72609096|NCT00644059|144746899|SUPERIORITY_OR_OTHER||GMT [B/Florida/2006]|0.97|||||TWO_SIDED|95.0|0.9|1.05|||ANOVA|||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 1 for strain B/Florida/2006 in terms of GMTs in subjects aged 6 to \<72 months by HI assay.||1.05|0.9|
72609097|NCT00644059|144746899|SUPERIORITY_OR_OTHER||GMT [B/Florida/2006]|1.56|||||TWO_SIDED|95.0|1.26|1.93|||ANOVA|||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 29 for strain B/Florida/2006 in terms of GMTs in subjects aged 6 to \<72 months by HI assay.||1.93|1.26|
72609098|NCT00644059|144746899|SUPERIORITY_OR_OTHER||GMT [B/Florida/2006]|5.0|||||TWO_SIDED|95.0|4.25|5.88|||ANOVA|||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 50 for strain B/Florida/2006 in terms of GMTs in subjects aged 6 to \<72 months by HI assay.||5.88|4.25|
72609099|NCT00644059|144746899|SUPERIORITY_OR_OTHER||GMT [B/Florida/2006]|2.55|||||TWO_SIDED|95.0|2.22|2.93|||ANOVA|||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 181 for strain B/Florida/2006 in terms of GMTs in subjects aged 6 to \<72 months by HI assay.||2.93|2.22|
72609100|NCT00644059|144746899|SUPERIORITY_OR_OTHER||GMT [A/Solomon Islands/2006 (A/H1N1)]|0.96|||||TWO_SIDED|95.0|0.75|1.22|||ANOVA|||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day1 for strain A/Solomon Islands/2006 (A/H1N1) in terms of GMTs in subjects aged 6 to \<72 months by HI assay.||1.22|0.75|
72609101|NCT00644059|144746899|SUPERIORITY_OR_OTHER||GMT [A/Solomon Islands/2006 (A/H1N1)]|1.72|||||TWO_SIDED|95.0|1.17|2.51|||ANOVA|||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 29 for strain A/Solomon Islands/2006 (A/H1N1) in terms of GMTs in subjects aged 6 to \<72 months by HI assay.||2.51|1.17|
72609102|NCT00644059|144746899|SUPERIORITY_OR_OTHER||GMT [A/Solomon Islands/2006 (A/H1N1)]|5.58|||||TWO_SIDED|95.0|4.08|7.63|||ANOVA|||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 50 for strain A/Solomon Islands/2006 (A/H1N1) in terms of GMTs in subjects aged 6 to \<72 months by HI assay.||7.63|4.08|
72325626|NCT03247829|144174830|OTHER|||||||0.001|||||||t-test, 2 sided|Comparative p-values were calculated by two-sided t-tests (paired analysis).||||||0.001
72325627|NCT03247829|144174831|OTHER|||||||0.0931|||||||t-test, 2 sided|||||||0.0931
72325628|NCT01783444|144174839|NON_INFERIORITY|Hazard ratio obtained from stratified Cox model (stratified by presence/absence of visceral metastasis as per IWRS)|Hazard Ratio (HR)|0.74|||||TWO_SIDED|90.0|0.57|0.97||||||||0.97|0.57|
72325629|NCT01783444|144174840|NON_INFERIORITY|Hazard ratio obtained from stratified Cox model (stratified by presence/absence of visceral metastasis as per IWRS)|Hazard Ratio (HR)|1.26|||||TWO_SIDED|90.0|0.96|1.66||||||||1.66|0.96|
72325630|NCT01783444|144174841|NON_INFERIORITY|Hazard ratio obtained from stratified Cox model (stratified by presence/absence of visceral metastasis as per IWRS)|Hazard Ratio (HR)|1.27|||||TWO_SIDED|90.0|0.95|1.7||||||||1.70|0.95|
72325631|NCT01783444|144174841|NON_INFERIORITY|Hazard ratio obtained from stratified Cox model (stratified by presence/absence of visceral metastasis as per IWRS)|Hazard Ratio (HR)|1.33|||||TWO_SIDED|90.0|0.99|1.79||||||||1.79|0.99|
72325632|NCT01783444|144174844|NON_INFERIORITY|Hazard ratio obtained from stratified Cox model (stratified by presence/absence of visceral metastasis as per IWRS)|Hazard Ratio (HR)|1.09|||||TWO_SIDED|90.0|0.72|1.66||||||||1.66|0.72|
72325633|NCT01783444|144174844|NON_INFERIORITY|Hazard ratio obtained from stratified Cox model (stratified by presence/absence of visceral metastasis as per IWRS)|Hazard Ratio (HR)|1.18|||||TWO_SIDED|90.0|0.78|1.77||||||||1.77|0.78|
72325634|NCT01783444|144174845|NON_INFERIORITY|Hazard ratio obtained from stratified Cox model (stratified by presence/absence of visceral metastasis as per IWRS)|Hazard Ratio (HR)|0.64|||||TWO_SIDED|90.0|0.46|0.88||||||||0.88|0.46|
72325635|NCT01783444|144174845|NON_INFERIORITY|Hazard ratio obtained from stratified Cox model (stratified by presence/absence of visceral metastasis as per IWRS)|Hazard Ratio (HR)|1.33|||||TWO_SIDED|90.0|0.93|1.91||||||||1.91|0.93|
72325636|NCT01783444|144174846|OTHER||Mean Difference (Net)|4.3|||||TWO_SIDED|90.0|-3.3|11.9||||||Side-effects||11.9|-3.3|
72325637|NCT01783444|144174846|OTHER||Mean Difference (Net)|-2.2|||||TWO_SIDED|90.0|-9.9|5.5||||||Side-effects||5.5|-9.9|
72325638|NCT01783444|144174846|OTHER||Mean Difference (Net)|-3.3|||||TWO_SIDED|90.0|-10.4|3.8||||||Effectiveness||3.8|-10.4|
72325639|NCT01783444|144174846|OTHER||Mean Difference (Net)|-3.3|||||TWO_SIDED|90.0|-9.7|3.0||||||Effectiveness||3.0|-9.7|
72417774|NCT00985725|144346086|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.6||||0.009|TWO_SIDED|95.0|-9.8|-1.4|||ANCOVA|||Shift subscale||-1.4|-9.8|0.0090
72609103|NCT00644059|144746899|SUPERIORITY_OR_OTHER||GMT [A/Solomon Islands/2006 (A/H1N1)]|3.11|||||TWO_SIDED|95.0|2.3|4.2|||ANOVA|||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 181 for strain A/Solomon Islands/2006 (A/H1N1) in terms of GMTs in subjects aged 6 to \<72 months by HI assay.||4.2|2.3|
72609104|NCT00644059|144746899|SUPERIORITY_OR_OTHER||GMT [A/Wisconsin/2009 (A/H3N2)]|0.98|||||TWO_SIDED|95.0|0.74|1.3|||ANOVA|||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 1 for strain A/Wisconsin/2009 (A/H3N2) in terms of GMTs in subjects aged 6 to \<72 months by HI assay.||1.3|0.74|
72609105|NCT00644059|144746899|SUPERIORITY_OR_OTHER||GMT [A/Wisconsin/2009 (A/H3N2)]|3.14|||||TWO_SIDED|95.0|2.19|4.49|||ANOVA|||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 29 for strain A/Wisconsin/2009 (A/H3N2) in terms of GMTs in subjects aged 6 to \<72 months by HI assay.||4.49|2.19|
72609106|NCT00644059|144746899|SUPERIORITY_OR_OTHER||GMT [A/Wisconsin/2009 (A/H3N2)]|7.36|||||TWO_SIDED|95.0|5.51|9.82|||ANOVA|||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 50 for strain A/Wisconsin/2009 (A/H3N2) in terms of GMTs in subjects aged 6 to \<72 months by HI assay.||9.82|5.51|
72609107|NCT00644059|144746899|SUPERIORITY_OR_OTHER||GMT [A/Wisconsin/2009 (A/H3N2)]|2.66|||||TWO_SIDED|95.0|2.0|3.55|||ANOVA|||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 181 for strain A/Wisconsin/2009 (A/H3N2) in terms of GMTs in subjects aged 6 to \<72 months by HI assay.||3.55|2|
72609108|NCT00644059|144746899|SUPERIORITY_OR_OTHER||GMT [B/Brisbane/2008]|1.0|||||TWO_SIDED|95.0|0.98|1.01|||ANOVA|||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 1 for strain B/Brisbane/2008 in terms of GMTs in subjects aged 6 to \<72 months by HI assay.||1.01|0.98|
72609109|NCT00644059|144746899|SUPERIORITY_OR_OTHER||GMT [B/Brisbane/2008]|1.13|||||TWO_SIDED|95.0|1.05|1.22|||ANOVA|||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 29 for strain B/Brisbane/2008 in terms of GMTs in subjects aged 6 to \<72 months by HI assay.||1.22|1.05|
72609110|NCT00644059|144746899|SUPERIORITY_OR_OTHER||GMT [B/Brisbane/2008]|1.79|||||TWO_SIDED|95.0|1.63|1.97|||ANOVA|||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 50 for strain B/Brisbane/2008 in terms of GMTs in subjects aged 6 to \<72 months by HI assay.||1.97|1.63|
72609111|NCT00644059|144746899|SUPERIORITY_OR_OTHER||GMT [B/Brisbane/2008]|1.08|||||TWO_SIDED|95.0|1.0|1.17|||ANOVA|||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 181 for strain B/Brisbane/2008 in terms of GMTs in subjects aged 6 to \<72 months by HI assay.||1.17|1|
72609112|NCT02662569|144746925|SUPERIORITY||LS Mean Treatment Difference|-70.29|STANDARD_ERROR_OF_MEAN|2.61|<|0.0001|TWO_SIDED|95.0|-75.43|-65.16||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit|Treatment difference = Evolocumab Q2W - Placebo Q2W|||-65.16|-75.43|<0.0001
72609113|NCT02662569|144746925|SUPERIORITY||LS Mean Treatment Difference|-70.04|STANDARD_ERROR_OF_MEAN|2.35|<|0.0001|TWO_SIDED|95.0|-74.67|-65.41||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit|Treatment difference = Evolocumab QM - Placebo QM|||-65.41|-74.67|<0.0001
72609114|NCT02662569|144746926|SUPERIORITY||LS Mean Treatment Difference|-71.77|STANDARD_ERROR_OF_MEAN|2.97|<|0.0001|TWO_SIDED|95.0|-77.61|-65.93||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit|Treatment difference = Evolocumab Q2W - Placebo Q2W|||-65.93|-77.61|<0.0001
72609115|NCT02662569|144746926|SUPERIORITY||LS Mean Treatment Difference|-64.93|STANDARD_ERROR_OF_MEAN|2.56|<|0.0001|TWO_SIDED|95.0|-69.97|-59.89||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit|Treatment difference = Evolocumab QM - Placebo QM|||-59.89|-69.97|<0.0001
72609116|NCT02662569|144746927|SUPERIORITY||LS Mean Treatment Difference|-62.5|STANDARD_ERROR_OF_MEAN|2.9|<|0.0001|TWO_SIDED|95.0|-68.2|-56.9||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit|Treatment difference = Evolocumab Q2W - Placebo Q2W|||-56.9|-68.2|<0.0001
72325640|NCT01783444|144174846|OTHER||Mean Difference (Net)|-1.6|||||TWO_SIDED|90.0|-5.8|2.5||||||Convenience||2.5|-5.8|
72609117|NCT02662569|144746927|SUPERIORITY||LS Mean Treatment Difference|-63.1|STANDARD_ERROR_OF_MEAN|2.7|<|0.0001|TWO_SIDED|95.0|-68.4|-57.8||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit|Treatment difference = Evolocumab QM - Placebo QM|||-57.8|-68.4|<0.0001
72417775|NCT00985725|144346086|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.7||||0.0793|TWO_SIDED|95.0|-7.9|0.4|||ANCOVA|||Emotional control subscale||0.4|-7.9|0.0793
72609118|NCT02662569|144746928|SUPERIORITY||LS Mean Treatment Difference|-63.6|STANDARD_ERROR_OF_MEAN|3.1|<|0.0001|TWO_SIDED|95.0|-69.7|-57.6||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit|Treatment difference = Evolocumab Q2W - Placebo Q2W|||-57.6|-69.7|<0.0001
72609119|NCT02662569|144746928|SUPERIORITY||LS Mean Treatment Difference|-58.8|STANDARD_ERROR_OF_MEAN|2.8|<|0.0001|TWO_SIDED|95.0|-64.3|-53.3||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit|Treatment difference = Evolocumab QM - Placebo QM|||-53.3|-64.3|<0.0001
72609120|NCT02662569|144746929|SUPERIORITY||LS Mean Treatment Difference|-60.9|STANDARD_ERROR_OF_MEAN|2.35|<|0.0001|TWO_SIDED|95.0|-65.51|-56.29||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit|Treatment difference = Evolocumab Q2W - Placebo Q2W|||-56.29|-65.51|<0.0001
72609121|NCT02662569|144746929|SUPERIORITY||LS Mean Treatment Difference|-59.4|STANDARD_ERROR_OF_MEAN|2.09|<|0.0001|TWO_SIDED|95.0|-63.52|-55.29||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit|Treatment difference = Evolocumab QM - Placebo QM|||-55.29|-63.52|<0.0001
72609122|NCT02662569|144746930|SUPERIORITY||LS Mean Treatment Difference|-61.64|STANDARD_ERROR_OF_MEAN|2.64|<|0.0001|TWO_SIDED|95.0|-66.82|-56.45||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit|Treatment difference = Evolocumab Q2W - Placebo Q2W|||-56.45|-66.82|<0.0001
72609123|NCT02662569|144746930|SUPERIORITY||LS Mean Treatment Difference|-54.22|STANDARD_ERROR_OF_MEAN|2.28|<|0.0001|TWO_SIDED|95.0|-58.7|-49.74||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit|Treatment difference = Evolocumab QM - Placebo QM|||-49.74|-58.70|<0.0001
72609124|NCT02662569|144746931|SUPERIORITY||LS Mean Treatment Difference|-56.93|STANDARD_ERROR_OF_MEAN|2.03|<|0.0001|TWO_SIDED|95.0|-60.93|-52.93||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit|Treatment difference = Evolocumab Q2W - Placebo Q2W|||-52.93|-60.93|<0.0001
72609125|NCT02662569|144746931|SUPERIORITY||LS Mean Treatment Difference|-54.85|STANDARD_ERROR_OF_MEAN|1.87|<|0.0001|TWO_SIDED|95.0|-58.52|-51.18||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit|Treatment difference = Evolocumab QM - Placebo QM|||-51.18|-58.52|<0.0001
72609126|NCT02662569|144746932|SUPERIORITY||LS Mean Treatment Difference|-57.06|STANDARD_ERROR_OF_MEAN|2.3|<|0.0001|TWO_SIDED|95.0|-61.59|-52.54||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit|Treatment difference = Evolocumab Q2W - Placebo Q2W|||-52.54|-61.59|<0.0001
72609127|NCT02662569|144746932|SUPERIORITY||LS Mean Treatment Difference|-49.42|STANDARD_ERROR_OF_MEAN|1.98|<|0.0001|TWO_SIDED|95.0|-53.31|-45.53||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit|Treatment difference = Evolocumab QM - Placebo QM|||-45.53|-53.31|<0.0001
72609128|NCT02662569|144746933|SUPERIORITY||LS Mean Treatment Difference|-41.53|STANDARD_ERROR_OF_MEAN|1.74|<|0.0001|TWO_SIDED|95.0|-44.95|-38.1||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit|Treatment difference = Evolocumab Q2W - Placebo Q2W|||-38.10|-44.95|<0.0001
72609129|NCT02662569|144746933|SUPERIORITY||LS Mean Treatment Difference|-39.5|STANDARD_ERROR_OF_MEAN|1.51|<|0.0001|TWO_SIDED|95.0|-42.47|-36.53||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit|Treatment difference = Evolocumab QM - Placebo QM|||-36.53|-42.47|<0.0001
72325641|NCT01783444|144174846|OTHER||Mean Difference (Net)|-1.1|||||TWO_SIDED|90.0|-5.5|3.3||||||Convenience||3.3|-5.5|
72325642|NCT01783444|144174846|OTHER||Mean Difference (Net)|-2.7|||||TWO_SIDED|90.0|-8.3|2.9||||||Global Satisfaction||2.9|-8.3|
72325643|NCT01783444|144174846|OTHER||Mean Difference (Net)|-3.3|||||TWO_SIDED|90.0|-8.4|1.9||||||Global Satisfaction||1.9|-8.4|
72325644|NCT01334554|144174871|SUPERIORITY_OR_OTHER||Beta coefficient (linear regression)|0.12||||0.55|TWO_SIDED|95.0|-0.33|0.58||p- value was unadjusted. Primary outcome underwent logarithmic transformation|Regression, Linear|||H0= 4-week treatment with sildenafil citrate does not improve insulin sensitivity in obese African American women.||0.58|-0.33|0.55
72325645|NCT01334554|144174872|SUPERIORITY_OR_OTHER||Beta coefficient|0.46||||0.649|TWO_SIDED|95.0|-1.58|2.49||Adjusted for baseline values only|Regression, Linear|||||2.49|-1.58|0.649
72325646|NCT02393859|144174873|SUPERIORITY||Normal score|-11.54|||<|0.001||||||Stratification factors were: age (1 to 9 years vs other \[\< 1 year and \> 9 years\]), and marrow/MRD status (M1 with MRD level \< 10\^-3 vs M1 with MRD level ≥ 10\^-3 vs M2).|Stratified log-rank test||A normal score \< 0 indicates fewer than expected events for blinatumomab relative to HC3 and therefore a longer event-free survival time.|||||< 0.001
72325647|NCT02393859|144174873|SUPERIORITY||Normal score|-11.16||||0.001|||||||Unstratified log-rank test||A normal score \< 0 indicates fewer than expected events for blinatumomab relative to HC3 and therefore a longer event-free survival time.|||||0.001
72325648|NCT02393859|144174873|SUPERIORITY||Stratified hazard ratio (HR)|0.36|||||TWO_SIDED|95.0|0.19|0.66|||||Cox proportional hazard model. Stratification factors were: age and marrow/MRD status. (HR \< 1.0 indicates a lower average event rate and a longer EFS for blinatumomab relative to HC3.)|||0.66|0.19|
72325649|NCT02393859|144174873|SUPERIORITY||Unstratified HR|0.39|||||TWO_SIDED|95.0|0.22|0.7|||||Cox proportional hazard model. (HR \< 1.0 indicates a lower average event rate and a longer EFS for blinatumomab relative to HC3.)|||0.70|0.22|
72417776|NCT00985725|144346086|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.2||||0.1014|TWO_SIDED|95.0|-7.0|0.6|||ANCOVA|||Self-monitor subscale||0.6|-7.0|0.1014
72417777|NCT00985725|144346086|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-9.0||||0.0002|TWO_SIDED|95.0|-13.7|-4.3|||ANCOVA|||Metacognition index||-4.3|-13.7|0.0002
72417778|NCT00985725|144346086|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-8.6||||0.0002|TWO_SIDED|95.0|-12.9|-4.2|||ANCOVA|||Initiate subscale||-4.2|-12.9|0.0002
72417779|NCT00985725|144346086|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-9.1||||0.0001|TWO_SIDED|95.0|-13.7|-4.5|||ANCOVA|||Working memory subscale||-4.5|-13.7|0.0001
72417780|NCT00985725|144346086|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-7.5||||0.001|TWO_SIDED|95.0|-11.9|-3.1|||ANCOVA|||Plan/Organize subscale||-3.1|-11.9|0.0010
72325650|NCT02393859|144174873|SUPERIORITY||Stratified HR w/time-dependent covariate|0.36|||||TWO_SIDED|95.0|0.2|0.64|||||Cox proportional hazard model including time from randomization to allogeneic hematopoietic stem cell transplant. Stratification factors: age and marrow/MRD status. (HR \<1.0=lower average event rate and longer EFS for blinatumomab relative to HC3.)|||0.64|0.20|
72325651|NCT02393859|144174874|SUPERIORITY||Normal score|-13.9|||<|0.001||||||Stratification factors were: age (1 to 9 years vs other \[\< 1 year and \> 9 years\]), and marrow/MRD status (M1 with MRD level \< 10\^-3 vs M1 with MRD level ≥ 10\^-3 vs M2).|Stratified log-rank test||A normal score \< 0 indicates fewer than expected events for blinatumomab relative to HC3 and therefore a longer event-free survival time.|||||< 0.001
72325652|NCT02393859|144174874|SUPERIORITY||Normal score|-13.61|||<|0.001|||||||Unstratified log-rank test||A normal score \< 0 indicates fewer than expected events for Blinatumomab relative to HC3 and therefore a longer event free survival time.|||||< 0.001
72325653|NCT02393859|144174874|SUPERIORITY||Stratified HR|0.35|||||TWO_SIDED|95.0|0.2|0.61|||||Cox proportional hazard model. Stratification factors were: age and marrow/MRD status. (HR \< 1.0 indicates a lower average event rate and a longer EFS for blinatumomab relative to HC3.)|||0.61|0.20|
72325654|NCT02393859|144174874|SUPERIORITY||Unstratified HR|0.38|||||TWO_SIDED|95.0|0.22|0.65|||||Cox proportional hazard model. (HR \< 1.0 indicates a lower average event rate and a longer EFS for blinatumomab relative to HC3.)|||0.65|0.22|
72325655|NCT02393859|144174874|SUPERIORITY||Stratified HR w/time-dependent covariate|0.34|||||TWO_SIDED|95.0|0.2|0.59|||||Cox proportional hazard model including time from randomization to allogeneic hematopoietic stem cell transplant. Stratification factors: age and marrow/MRD status. (HR \<1.0=lower average event rate and longer EFS for blinatumomab relative to HC3.)|||0.59|0.20|
72325656|NCT02393859|144174875|SUPERIORITY||Normal score|-10.14||||0.001||||||Stratification factors were: age (1 to 9 years vs other \[\< 1 year and \> 9 years\]), and marrow/MRD status (M1 with MRD level \< 10\^-3 vs M1 with MRD level ≥ 10\^-3 vs M2).|Stratified log-rank test||A normal score \< 0 indicates fewer than expected events for blinatumomab relative to HC3 and therefore a longer event-free survival time.|||||0.001
72325657|NCT02393859|144174875|SUPERIORITY||Normal score|-10.32|||<|0.001|||||||Unstratified log-rank test||A normal score \< 0 indicates fewer than expected events for blinatumomab relative to HC3 and therefore a longer event-free survival time.|||||< 0.001
72325658|NCT02393859|144174875|SUPERIORITY||Stratified HR|0.33|||||TWO_SIDED|95.0|0.16|0.66|||||Cox proportional hazard model. Stratification factors were: age and marrow/MRD status. (HR \< 1.0 indicates a lower average event rate and a longer survival for blinatumomab relative to HC3.)|||0.66|0.16|
72325659|NCT02393859|144174875|SUPERIORITY||Unstratified HR|0.32|||||TWO_SIDED|95.0|0.16|0.65|||||Cox proportional hazard model. (HR \< 1.0 indicates a lower average event rate and a longer survival for blinatumomab relative to HC3.)|||0.65|0.16|
72325660|NCT02393859|144174876|SUPERIORITY||||||<|0.001||||||Cochran-Mantel-Haenszel test adjusting for the stratification factors: age (1 to 9 years vs other \[\< 1 year and \> 9 years\]), and marrow/MRD status (M1 with MRD level \< 10\^-3 vs M1 with MRD level ≥ 10\^-3 vs M2).|Cochran-Mantel-Haenszel|||MRD response by PCR||||< 0.001
72325661|NCT02393859|144174876|SUPERIORITY||||||<|0.001||||||Cochran-Mantel-Haenszel test adjusting for the stratification factors: age (1 to 9 years vs other \[\< 1 year and \> 9 years\]), and marrow/MRD status (M1 with MRD level \< 10-3 vs M1 with MRD level ≥ 10-3 vs M2).|Cochran-Mantel-Haenszel|||MRD response by flow cytometry||||< 0.001
72325662|NCT02393859|144174877|SUPERIORITY||Hazard Ratio (HR)|0.29|||||TWO_SIDED|95.0|0.16|0.52|||||The subdistribution HR estimates are obtained from the subdistribution Cox model. (HR \< 1.0 indicates a lower average event rate and a longer relapse-free time for blinatumomab relative to HC3.)|||0.52|0.16|
72325663|NCT02393859|144174877|SUPERIORITY||Stratified hazard ratio (HR)|0.27|||||TWO_SIDED|95.0|0.15|0.48|||||The subdistribution HR estimates are obtained from the subdistribution Cox model. (HR \< 1.0 indicates a lower average event rate and a longer relapse-free time for blinatumomab relative to HC3.) Stratification factors are age and marrow/MRD status.|||0.48|0.15|
72325664|NCT00954447|144174885|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.65|STANDARD_ERROR_OF_MEAN|0.05|<|0.0001||95.0|-0.74|-0.55|||ANCOVA||Linagliptin 5mg - Placebo|||-0.55|-0.74|<0.0001
72325665|NCT00954447|144174886|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.935|||<|0.0001||95.0|1.949|4.419|||Regression, Logistic|Logistic regression of HbA1c \< 7.0 percent at week 52|Linagliptin 5mg vs. Placebo OR adjusted for baseline HbA1c, categorical renal function impairment, concomitant OADs and treatment|FAS with baseline HbA1c \>= 7.0 percent (NCF); there are 593 available values for Placebo and 595 for Linagliptin 5mg||4.419|1.949|<0.0001
72325666|NCT00954447|144174888|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.45|STANDARD_ERROR_OF_MEAN|0.03|<|0.0001||95.0|-0.51|-0.39|||ANCOVA||Linagliptin 5mg - Placebo|||-0.39|-0.51|<0.0001
72325667|NCT00954447|144174889|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.61|STANDARD_ERROR_OF_MEAN|0.04|<|0.0001||95.0|-0.69|-0.52|||ANCOVA||Linagliptin 5mg - Placebo|||-0.52|-0.69|<0.0001
72325668|NCT00954447|144174890|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.67|STANDARD_ERROR_OF_MEAN|0.05|<|0.0001||95.0|-0.76|-0.57|||ANCOVA||Linagliptin 5mg - Placebo|||-0.57|-0.76|<0.0001
72325669|NCT00954447|144174891|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.57|STANDARD_ERROR_OF_MEAN|0.05|<|0.0001||95.0|-0.67|-0.47|||ANCOVA||Linagliptin 5mg - Placebo|||-0.47|-0.67|<0.0001
72417781|NCT00985725|144346086|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.9||||0.0357|TWO_SIDED|95.0|-9.4|-0.3|||ANCOVA|||Task monitor subscale||-0.3|-9.4|0.0357
72417782|NCT00985725|144346086|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-7.0||||0.0012|TWO_SIDED|95.0|-11.1|-2.8|||ANCOVA|||Organization of materials subscale||-2.8|-11.1|0.0012
72325670|NCT00954447|144174892|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.55|STANDARD_ERROR_OF_MEAN|0.05|<|0.0001||95.0|-0.65|-0.45|||ANCOVA||Linagliptin 5mg - Placebo|||-0.45|-0.65|<0.0001
72417783|NCT00985725|144346091|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.4||||0.1731|TWO_SIDED|95.0|-10.9|2.0|||ANCOVA|||||2.0|-10.9|0.1731
72417784|NCT03563716|144346099|SUPERIORITY||Odds Ratio (OR)|2.57|||||TWO_SIDED|95.0|1.07|6.14|||||95% CI for odds ratio was constructed using the Wald method.|Stratified analysis based on PD-L1 immunohistochemistry (IHC) 22C3 pharmDx, tumor histology status, and tobacco history.||6.14|1.07|
72417785|NCT03563716|144346100|SUPERIORITY||Hazard Ratio (HR)|0.57|||||TWO_SIDED|95.0|0.37|0.9|||||Hazard ratios were estimated by Cox regression.|Stratified analysis based on PD-L1 IHC 22C3 pharmDx, tumor histology status, and tobacco history.||0.90|0.37|
72417786|NCT00338884|144346123|SUPERIORITY_OR_OTHER||Objective Response Rate (ORR) (percent)|35.3|||||TWO_SIDED|95.0|26.7|44.8|||||ORR=proportion of subjects with confirmed CR or PR, relative to total subjects who received at least 1 dose of study medication, had a baseline disease assessment, and had the correct histological cancer type.|||44.8|26.7|
72325671|NCT00954447|144174893|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.53|STANDARD_ERROR_OF_MEAN|0.05|<|0.0001||95.0|-0.64|-0.43|||ANCOVA||Linagliptin 5mg - Placebo|||-0.43|-0.64|<0.0001
72325672|NCT00954447|144174894|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.6|STANDARD_ERROR_OF_MEAN|2.49|<|0.0001||95.0|-16.49|-6.71|||ANCOVA||Linagliptin 5mg - Placebo|||-6.71|-16.49|<0.0001
72417787|NCT00338884|144346129|SUPERIORITY_OR_OTHER|||||||0.5581|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 1 (CR or PR Versus PD)||||0.5581
72417788|NCT00338884|144346129|SUPERIORITY_OR_OTHER|||||||0.7635|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 3 (CR or PR Versus PD)||||0.7635
72417789|NCT00338884|144346129|SUPERIORITY_OR_OTHER|||||||0.8366|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 5 (CR or PR Versus PD)||||0.8366
72609130|NCT02662569|144746934|SUPERIORITY||LS Mean Treatment Difference|-42.22|STANDARD_ERROR_OF_MEAN|1.93|<|0.0001|TWO_SIDED|95.0|-46.02|-38.42||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit|Treatment difference = Evolocumab Q2W - Placebo Q2W|||-38.42|-46.02|<0.0001
72609131|NCT02662569|144746934|SUPERIORITY||LS Mean Treatment Difference|-35.89|STANDARD_ERROR_OF_MEAN|1.64|<|0.0001|TWO_SIDED|95.0|-39.12|-32.67||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit|Treatment difference = Evolocumab QM - Placebo QM|||-32.67|-39.12|<0.0001
72609132|NCT02662569|144746935|SUPERIORITY||LS Mean Treatment Difference|-44.09|STANDARD_ERROR_OF_MEAN|1.81|<|0.0001|TWO_SIDED|95.0|-47.64|-40.54||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit|Treatment difference = Evolocumab Q2W - Placebo Q2W|||-40.54|-47.64|<0.0001
72609133|NCT02662569|144746935|SUPERIORITY||LS Mean Treatment Difference|-43.67|STANDARD_ERROR_OF_MEAN|1.64|<|0.0001|TWO_SIDED|95.0|-46.9|-40.44||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit|Treatment difference = Evolocumab QM - Placebo QM|||-40.44|-46.90|<0.0001
72609134|NCT02662569|144746936|SUPERIORITY||LS Mean Treatment Difference|-43.94|STANDARD_ERROR_OF_MEAN|2.02|<|0.0001|TWO_SIDED|95.0|-47.9|-39.97||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit|Treatment difference = Evolocumab Q2W - Placebo Q2W|||-39.97|-47.90|<0.0001
72609135|NCT02662569|144746936|SUPERIORITY||LS Mean Treatment Difference|-40.56|STANDARD_ERROR_OF_MEAN|1.79|<|0.0001|TWO_SIDED|95.0|-44.08|-37.04||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit|Treatment difference = Evolocumab QM - Placebo QM|||-37.04|-44.08|<0.0001
72609136|NCT02662569|144746937|SUPERIORITY||LS Mean Treatment Difference|-58.2|STANDARD_ERROR_OF_MEAN|2.01|<|0.0001|TWO_SIDED|95.0|-62.15|-54.25||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit|Treatment difference = Evolocumab Q2W - Placebo Q2W|||-54.25|-62.15|<0.0001
72325673|NCT00954447|144174897|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.58|STANDARD_ERROR_OF_MEAN|0.53||0.0029||95.0|-2.61|-0.54|||ANCOVA||Linagliptin 5mg - Placebo|||-0.54|-2.61|0.0029
72417790|NCT00338884|144346129|SUPERIORITY_OR_OTHER|||||||0.0278|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 7 (CR or PR Versus PD)||||0.0278
72417791|NCT00338884|144346129|SUPERIORITY_OR_OTHER|||||||0.1988|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 9 (CR or PR Versus PD)||||0.1988
72417792|NCT00338884|144346129|SUPERIORITY_OR_OTHER|||||||0.2898|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 13 (CR or PR Versus PD)||||0.2898
72417793|NCT00338884|144346129|SUPERIORITY_OR_OTHER|||||||0.3567|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 17 (CR or PR Versus PD)||||0.3567
72417794|NCT00338884|144346129|SUPERIORITY_OR_OTHER|||||||0.4547|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 21 (CR or PR Versus PD)||||0.4547
72609137|NCT02662569|144746937|SUPERIORITY||LS Mean Treatment Difference|-56.73|STANDARD_ERROR_OF_MEAN|1.93|<|0.0001|TWO_SIDED|95.0|-60.53|-52.93||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit|Treatment difference = Evolocumab QM - Placebo QM|||-52.93|-60.53|<0.0001
72609138|NCT02662569|144746938|SUPERIORITY||LS Mean Treatment Difference|-58.21|STANDARD_ERROR_OF_MEAN|2.23|<|0.0001|TWO_SIDED|95.0|-62.59|-53.84||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit|Treatment difference = Evolocumab Q2W - Placebo Q2W|||-53.84|-62.59|<0.0001
72609139|NCT02662569|144746938|SUPERIORITY||LS Mean Treatment Difference|-51.7|STANDARD_ERROR_OF_MEAN|2.09|<|0.0001|TWO_SIDED|95.0|-55.81|-47.59||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit|Treatment difference = Evolocumab QM - Placebo QM|||-47.59|-55.81|<0.0001
72417795|NCT00338884|144346129|SUPERIORITY_OR_OTHER|||||||0.2809|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 25 (CR or PR Versus PD)||||0.2809
72417796|NCT00338884|144346129|SUPERIORITY_OR_OTHER|||||||0.3259|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 29 (CR or PR Versus PD)||||0.3259
72417797|NCT00338884|144346129|SUPERIORITY_OR_OTHER|||||||0.2702|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 33 (CR or PR Versus PD)||||0.2702
72417798|NCT00338884|144346130|SUPERIORITY_OR_OTHER|||||||0.7154|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 1 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)||||0.7154
72325674|NCT00954447|144174900|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.327|||<|0.0001||95.0|2.221|8.43|||Regression, Logistic|Logistic regression of HbA1c \< 6.5 percent at week 52|Linagliptin 5mg vs. Placebo OR adjusted for baseline HbA1c, categorical renal function impairment, concomitant OADs and treatment|FAS with baseline HbA1c \>= 6.5 percent (NCF); there are 615 available values for Placebo and 616 for Linagliptin 5mg||8.430|2.221|<0.0001
72417799|NCT00338884|144346130|SUPERIORITY_OR_OTHER|||||||0.6263|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 3 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)||||0.6263
72417800|NCT00338884|144346130|SUPERIORITY_OR_OTHER|||||||0.9608|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 5 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)||||0.9608
72417801|NCT00338884|144346130|SUPERIORITY_OR_OTHER|||||||0.03|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 7 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)||||0.0300
72417802|NCT00338884|144346130|SUPERIORITY_OR_OTHER|||||||0.0927|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 9 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)||||0.0927
72417803|NCT00338884|144346130|SUPERIORITY_OR_OTHER|||||||0.2873|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 13 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)||||0.2873
72417804|NCT00338884|144346130|SUPERIORITY_OR_OTHER|||||||0.3018|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 17 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)||||0.3018
72417805|NCT00338884|144346130|SUPERIORITY_OR_OTHER|||||||0.4161|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 21 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)||||0.4161
72417806|NCT00338884|144346130|SUPERIORITY_OR_OTHER|||||||0.3069|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 25 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)||||0.3069
72325675|NCT01747915|144174946|SUPERIORITY||Least Square (LS) Mean Difference|0.02|STANDARD_ERROR_OF_MEAN|0.088||0.8121|TWO_SIDED|95.0|-0.15|0.19|||ANCOVA|||Estimates and p-values from an ANCOVA model including fixed effects for log transformed baseline value, region, age strata, and treatment group.||0.19|-0.15|0.8121
72417807|NCT00338884|144346130|SUPERIORITY_OR_OTHER|||||||0.292|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 29 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)||||0.2920
72417808|NCT00338884|144346130|SUPERIORITY_OR_OTHER|||||||0.2409|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 33 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)||||0.2409
72417809|NCT00338884|144346132|SUPERIORITY_OR_OTHER|||||||0.5784|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 1 (CR or PR Versus PD)||||0.5784
72609140|NCT02662569|144746939|SUPERIORITY||Treatment Difference|68.4|||<|0.0001|TWO_SIDED|95.0|60.4|74.8||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Cochran-Mantel Haenszel test stratified by entry statin therapy and geographic region.|Treatment difference = Evolocumab Q2W - Placebo Q2W|||74.8|60.4|<0.0001
72609141|NCT02662569|144746939|SUPERIORITY||Treatment Difference|71.9|||<|0.0001|TWO_SIDED|95.0|64.1|77.9||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Cochran-Mantel Haenszel test stratified by entry statin therapy and geographic region.|Treatment difference = Evolocumab QM - Placebo QM|||77.9|64.1|<0.0001
72609142|NCT02662569|144746940|SUPERIORITY||Treatment Difference|67.2|||<|0.0001|TWO_SIDED|95.0|58.9|73.9||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Cochran-Mantel Haenszel test stratified by entry statin therapy and geographic region.|Treatment difference = Evolocumab Q2W - Placebo Q2W|||73.9|58.9|<0.0001
72609143|NCT02662569|144746940|SUPERIORITY||Treatment Difference|68.8|||<|0.0001|TWO_SIDED|95.0|60.6|75.3||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Cochran-Mantel Haenszel test stratified by entry statin therapy and geographic region.|Treatment difference = Evolocumab QM - Placebo QM|||75.3|60.6|<0.0001
72609144|NCT02662569|144746941|SUPERIORITY||LS Mean Treatment Difference|-55.52|STANDARD_ERROR_OF_MEAN|18.85|<|0.0001|TWO_SIDED|95.0|-92.64|-18.4||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit|Treatment difference = Evolocumab Q2W - Placebo Q2W|||-18.40|-92.64|<0.0001
72609145|NCT02662569|144746941|SUPERIORITY||LS Mean Treatment Difference|-50.77|STANDARD_ERROR_OF_MEAN|6.63|<|0.0001|TWO_SIDED|95.0|-63.82|-37.72||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit|Treatment difference = Evolocumab QM - Placebo QM|||-37.72|-63.82|<0.0001
72609146|NCT02662569|144746942|SUPERIORITY||LS Mean Treatment Difference|-62.46|STANDARD_ERROR_OF_MEAN|24.64|<|0.0001|TWO_SIDED|95.0|-110.89|-14.03||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit|Treatment difference = Evolocumab Q2W - Placebo Q2W|||-14.03|-110.89|<0.0001
72609147|NCT02662569|144746942|SUPERIORITY||LS Mean Treatment Difference|-45.32|STANDARD_ERROR_OF_MEAN|8.42|<|0.0001|TWO_SIDED|95.0|-61.87|-28.77||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit|Treatment difference = Evolocumab QM - Placebo QM|||-28.77|-61.87|<0.0001
72417810|NCT00338884|144346132|SUPERIORITY_OR_OTHER|||||||0.6251|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 3 (CR or PR Versus PD)||||0.6251
72417811|NCT00338884|144346132|SUPERIORITY_OR_OTHER|||||||0.1639|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 5 (CR or PR Versus PD)||||0.1639
72417812|NCT00338884|144346132|SUPERIORITY_OR_OTHER|||||||0.2782|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 7 (CR or PR Versus PD)||||0.2782
72417813|NCT00338884|144346132|SUPERIORITY_OR_OTHER|||||||0.8627|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 9 (CR or PR Versus PD)||||0.8627
72417814|NCT00338884|144346132|SUPERIORITY_OR_OTHER|||||||0.462|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 13 (CR or PR Versus PD)||||0.4620
72417815|NCT00338884|144346132|SUPERIORITY_OR_OTHER|||||||0.7575|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 17 (CR or PR Versus PD)||||0.7575
72417816|NCT00338884|144346132|SUPERIORITY_OR_OTHER|||||||0.3566|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 21 (CR or PR Versus PD)||||0.3566
72417817|NCT00338884|144346132|SUPERIORITY_OR_OTHER|||||||0.2809|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 25 (CR or PR Versus PD)||||0.2809
72417818|NCT00338884|144346132|SUPERIORITY_OR_OTHER|||||||0.8758|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 29 (CR or PR Versus PD)||||0.8758
72417819|NCT00338884|144346132|SUPERIORITY_OR_OTHER|||||||0.2702|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 33 (CR or PR Versus PD)||||0.2702
72417820|NCT00338884|144346133|SUPERIORITY_OR_OTHER|||||||0.7267|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 1 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)||||0.7267
72417821|NCT00338884|144346133|SUPERIORITY_OR_OTHER|||||||0.8555|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 3 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)||||0.8555
72609148|NCT02662569|144746943|SUPERIORITY||LS Mean Treatment Difference|-18.02|STANDARD_ERROR_OF_MEAN|4.01||0.0002|TWO_SIDED|95.0|-25.89|-10.14||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit|Treatment difference = Evolocumab Q2W - Placebo Q2W|||-10.14|-25.89|0.0002
72609149|NCT02662569|144746943|SUPERIORITY||LS Mean Treatment Difference|-15.63|STANDARD_ERROR_OF_MEAN|3.08|<|0.0001|TWO_SIDED|95.0|-21.69|-9.58||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit|Treatment difference = Evolocumab QM - Placebo QM|||-9.58|-21.69|<0.0001
72609150|NCT02662569|144746944|SUPERIORITY||LS Mean Treatment Difference|-16.41|STANDARD_ERROR_OF_MEAN|14.18||0.0002|TWO_SIDED|95.0|-24.63|-8.19||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit|Treatment difference = Evolocumab Q2W - Placebo Q2W|||-8.19|-24.63|0.0002
72609151|NCT02662569|144746944|SUPERIORITY||LS Mean Treatment Difference|-12.31|STANDARD_ERROR_OF_MEAN|3.28|<|0.0001|TWO_SIDED|95.0|-18.76|-5.86||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit|Treatment difference = Evolocumab QM - Placebo QM|||-5.86|-18.76|<0.0001
72417822|NCT00338884|144346133|SUPERIORITY_OR_OTHER|||||||0.2259|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 5 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)||||0.2259
72417823|NCT00338884|144346133|SUPERIORITY_OR_OTHER|||||||0.2074|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 7 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)||||0.2074
72417824|NCT00338884|144346133|SUPERIORITY_OR_OTHER|||||||0.4779|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 9 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)||||0.4779
72417825|NCT00338884|144346133|SUPERIORITY_OR_OTHER|||||||0.3628|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 13 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)||||0.3628
72609152|NCT02662569|144746945|SUPERIORITY||LS Mean Treatment Difference|6.34|STANDARD_ERROR_OF_MEAN|1.52||0.0003|TWO_SIDED|95.0|3.36|9.33||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit|Treatment difference = Evolocumab Q2W - Placebo Q2W|||9.33|3.36|0.0003
72609153|NCT02662569|144746945|SUPERIORITY||LS Mean Treatment Difference|7.87|STANDARD_ERROR_OF_MEAN|1.41|<|0.0001|TWO_SIDED|95.0|5.1|10.65||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit|Treatment difference = Evolocumab QM - Placebo QM|||10.65|5.10|<0.0001
72417826|NCT00338884|144346133|SUPERIORITY_OR_OTHER|||||||0.546|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 17 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)||||0.5460
72417827|NCT00338884|144346133|SUPERIORITY_OR_OTHER|||||||0.3637|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 21 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)||||0.3637
72609154|NCT02662569|144746946|SUPERIORITY||LS Mean Treatment Difference|5.88|STANDARD_ERROR_OF_MEAN|1.72||0.0003|TWO_SIDED|95.0|2.49|9.27||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit|Treatment difference = Evolocumab Q2W - Placebo Q2W|||9.27|2.49|0.0003
72417828|NCT00338884|144346133|SUPERIORITY_OR_OTHER|||||||0.2229|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 25 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)||||0.2229
72417829|NCT00338884|144346133|SUPERIORITY_OR_OTHER|||||||0.9759|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 29 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)||||0.9759
72417830|NCT00338884|144346133|SUPERIORITY_OR_OTHER|||||||0.2179|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 33 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)||||0.2179
72417831|NCT00338884|144346135|SUPERIORITY_OR_OTHER|||||||0.5784|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 1 (CR or PR Versus PD)||||0.5784
72417832|NCT00338884|144346135|SUPERIORITY_OR_OTHER|||||||0.9625|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 3 (CR or PR Versus PD)||||0.9625
72417833|NCT00338884|144346135|SUPERIORITY_OR_OTHER|||||||0.8519|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 5 (CR or PR Versus PD)||||0.8519
72417834|NCT00338884|144346135|SUPERIORITY_OR_OTHER||Wilcoxon Rank Sum Test|||||0.0513|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 7 (CR or PR Versus PD)||||0.0513
72417835|NCT00338884|144346135|SUPERIORITY_OR_OTHER|||||||0.4051|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 9 (CR or PR Versus PD)||||0.4051
72609155|NCT02662569|144746946|SUPERIORITY||LS Mean Treatment Difference|8.14|STANDARD_ERROR_OF_MEAN|1.58|<|0.0001|TWO_SIDED|95.0|5.03|11.25||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit|Treatment difference = Evolocumab QM - Placebo QM|||11.25|5.03|<0.0001
72609156|NCT02662569|144746947|SUPERIORITY||LS Mean Treatment Difference|-27.18|STANDARD_ERROR_OF_MEAN|3.57|<|0.0001|TWO_SIDED|95.0|-34.2|-20.17||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit|Treatment difference = Evolocumab Q2W - Placebo Q2W|||-20.17|-34.20|<0.0001
72609157|NCT02662569|144746947|SUPERIORITY||LS Mean Treatment Difference|-24.01|STANDARD_ERROR_OF_MEAN|2.99|<|0.0001|TWO_SIDED|95.0|-29.88|-18.14||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit|Treatment difference = Evolocumab QM - Placebo QM|||-18.14|-29.88|<0.0001
72325676|NCT01747915|144174946|SUPERIORITY||LS Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.088||0.8889|TWO_SIDED|95.0|-0.19|0.16|||ANCOVA|||Estimates and p-values from an ANCOVA model including fixed effects for log transformed baseline value, region, age strata, and treatment group.||0.16|-0.19|0.8889
72609158|NCT02295644|144746985|SUPERIORITY_OR_OTHER|||||||0.17||||||Interaction test of duty cycle and intensity for self reported pain score|ANOVA|||||||0.17
72609159|NCT02295644|144746985|SUPERIORITY_OR_OTHER|||||||0.14||||||Main effect of duty cycle on self reported pain score.|ANOVA|||||||0.14
72609160|NCT02295644|144746985|SUPERIORITY_OR_OTHER|||||||1||||||Main effect of intensity on self reported pain score.|ANOVA|||||||1.0
72609161|NCT02295644|144746986|SUPERIORITY_OR_OTHER|||||||0.24||||||Main effect for duty cycle.|ANOVA|||||||.24
72325677|NCT01747915|144174947|SUPERIORITY||Odds Ratio (OR)|1.095||||0.7973|TWO_SIDED|95.0|0.548|2.186||P-values were from a Logistic Regression Model including fixed effects for region, age strata and treatment.|Regression, Logistic|||||2.186|0.548|0.7973
72417836|NCT00338884|144346135|SUPERIORITY_OR_OTHER|||||||0.2548|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 13 (CR or PR Versus PD)||||0.2548
72417837|NCT00338884|144346135|SUPERIORITY_OR_OTHER|||||||0.5091|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 17 (CR or PR Versus PD)||||0.5091
72417838|NCT00338884|144346135|SUPERIORITY_OR_OTHER|||||||0.3133|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 21 (CR or PR Versus PD)||||0.3133
72609162|NCT02295644|144746986|SUPERIORITY_OR_OTHER|||||||0.019||||||Main effect for intensity.|ANOVA|||||||0.019
72609163|NCT02295644|144746986|SUPERIORITY_OR_OTHER|||||||0.17|||||||ANOVA|||Interaction of intensity and duty cycle.||||0.17
72609164|NCT02295644|144746987|SUPERIORITY_OR_OTHER|||||||0.034||||||Main effect for duty cycle.|ANOVA|||||||0.034
72609165|NCT02295644|144746987|SUPERIORITY_OR_OTHER|||||||0.475|||||||ANOVA|||Main effect for intensity.||||0.475
72609166|NCT02295644|144746987|SUPERIORITY_OR_OTHER|||||||0.178|||||||ANOVA|||Interaction of intensity and duty cycle.||||.178
72609167|NCT00324155|144747085|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.179||||0.4067|TWO_SIDED|95.0|0.799|1.74|||Cochran-Mantel-Haenszel|Stratified for metastasis stage (M0 vs M1a vs M1b vs M1c) and ECOG performance status (0 vs 1) recorded at randomization.||Analysis stratified for metastasis stage (M0 vs M1a vs M1b vs M1c) and Eastern Cooperative Oncology Group (ECOG) performance status (0 vs 1) recorded at randomization.||1.740|0.799|0.4067
72609168|NCT00324155|144747093|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.716||||0.0009|TWO_SIDED|95.0|0.588|0.872||p-value was via stratified log-rank test|Log Rank||Hazard ratio via stratified Cox proportional hazards model.|Analysis stratified for metastasis stage (M0 vs M1a vs M1b vs M1c) and Eastern Cooperative Oncology Group performance status (0 vs 1) recorded at randomization.||0.872|0.588|0.0009
72609169|NCT01924533|144747116|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.79||||0.0262|TWO_SIDED|97.5|0.63|1.0|||Cox proportional hazards model|||||1.00|0.63|0.0262
72609170|NCT01924533|144747117|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.73||||0.2458|TWO_SIDED|97.5|0.4|1.34|||Cox proportional hazards model|||||1.34|0.40|0.2458
72609171|NCT01924533|144747118|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.84||||0.0645|TWO_SIDED|97.5|0.67|1.04|||Cox proportional hazards model|||||1.04|0.67|0.0645
72609172|NCT01924533|144747119|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.74||||0.2199|TWO_SIDED|97.5|0.42|1.29|||Cox proportional hazards model|||||1.29|0.42|0.2199
72609173|NCT01924533|144747120|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.69||||0.0548|TWO_SIDED|97.5|0.92|3.17|||Regression, Logistic|||||3.17|0.92|0.0548
72609174|NCT01924533|144747121|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|4.24||||0.0309|TWO_SIDED|97.5|0.95|23.23|||Regression, Logistic|||||23.23|0.95|0.0309
72609175|NCT01924533|144747122|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.82||||0.0716|TWO_SIDED|97.5|0.64|1.05|||Cox proportional hazards model|||||1.05|0.64|0.0716
72609176|NCT01924533|144747123|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.63||||0.0927|TWO_SIDED|97.5|0.34|1.16|||Cox proportional hazards model|||||1.16|0.34|0.0927
72325678|NCT01747915|144174947|SUPERIORITY||Odds Ratio (OR)|0.934||||0.8474|TWO_SIDED|95.0|0.465|1.877||P-values were from a Logistic Regression Model including fixed effects for region, age strata and treatment.|Regression, Logistic|||||1.877|0.465|0.8474
72417839|NCT00338884|144346135|SUPERIORITY_OR_OTHER|||||||0.9278|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 25 (CR or PR Versus PD)||||0.9278
72417840|NCT00338884|144346135|SUPERIORITY_OR_OTHER|||||||0.407|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 29 (CR or PR Versus PD)||||0.4070
72325679|NCT00887159|144174958|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.98||||0.45|TWO_SIDED|95.0|0.65|1.47||P-value is one-sided.|Regression, Cox||The hazard ratio was derived comparing Arm B to Arm A.|There are 2 primary comparisons and each involves comparing the experimental arms (B, C) to the control arm (A). Accrual goal was 54 patients per arm. With a 1-sided 0.1 level logrank test for each test, we have 90% power to detect a 42% reduction in the PFS hazard rate of 0.139 to 0.082 (corresponding to an improvement in median PFS of 5 months to 8.5 months) with 18-month accrual and 12-month follow-up; assuming exponential survival. For each test, 94 events are needed to achieve this power.||1.47|0.65|0.45
72325680|NCT00887159|144174958|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.99||||0.48|TWO_SIDED|95.0|0.66|1.48||P-value is one-sided.|Regression, Cox||Hazard ratio was derived comparing Arm C to Arm A.|There are 2 primary comparisons and each involves comparing the experimental arms (B, C) to the control arm (A). Accrual goal was 54 patients per arm. With a 1-sided 0.1 level logrank test for each test, we have 90% power to detect a 42% reduction in the PFS hazard rate of 0.139 to 0.082 (corresponding to an improvement in median PFS of 5 months to 8.5 months) with 18-month accrual and 12-month follow-up; assuming exponential survival. For each test, 94 events are needed to achieve this power.||1.48|0.66|0.48
72325681|NCT00887159|144174961|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.69||||0.01|TWO_SIDED|95.0|1.13|2.52|||Regression, Cox||Hazard ratio was derived comparing the high CTCs group to the low CTCs group.|||2.52|1.13|0.01
72325682|NCT03181971|144174962|SUPERIORITY||Odds Ratio (OR)|0.7||||0.68|TWO_SIDED|95.0|0.2|2.9|||Mixed Models Analysis|||Analysis of between group change from baseline to 7 months.||2.9|0.2|0.68
72325683|NCT03181971|144174962|SUPERIORITY||Odds Ratio (OR)|0.1||||0.017|TWO_SIDED|95.0|0.03|0.7|||Mixed Models Analysis|||Analysis of between group change from baseline to 15 months||0.7|0.03|0.017
72325684|NCT03181971|144174963|SUPERIORITY||Odds Ratio (OR)|0.4||||0.24|TWO_SIDED|95.0|0.07|2.0|||Mixed Models Analysis|||Analysis of between group change from baseline to 7 months.||2.0|0.07|.24
72417841|NCT00338884|144346135|SUPERIORITY_OR_OTHER|||||||0.2703|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 33 (CR or PR Versus PD)||||0.2703
72417842|NCT00338884|144346136|SUPERIORITY_OR_OTHER|||||||0.7267|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 1 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)||||0.7267
72417843|NCT00338884|144346136|SUPERIORITY_OR_OTHER|||||||0.8286|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 3 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)||||0.8286
72417844|NCT00338884|144346136|SUPERIORITY_OR_OTHER|||||||0.6867|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 5 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)||||0.6867
72417845|NCT00338884|144346136|SUPERIORITY_OR_OTHER|||||||0.045|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 7 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)||||0.0450
72417846|NCT00338884|144346136|SUPERIORITY_OR_OTHER|||||||0.174|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 9 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)||||0.1740
72417847|NCT00338884|144346136|SUPERIORITY_OR_OTHER|||||||0.2703|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 13 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)||||0.2703
72417848|NCT00338884|144346136|SUPERIORITY_OR_OTHER|||||||0.3659|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 17 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)||||0.3659
72417849|NCT00338884|144346136|SUPERIORITY_OR_OTHER|||||||0.3391|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 21 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)||||0.3391
72417850|NCT00338884|144346136|SUPERIORITY_OR_OTHER|||||||0.98|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 25 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)||||0.9800
72417851|NCT00338884|144346136|SUPERIORITY_OR_OTHER|||||||0.335|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 29 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)||||0.3350
72417852|NCT00338884|144346136|SUPERIORITY_OR_OTHER|||||||0.2179|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 33 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)||||0.2179
72417853|NCT00338884|144346139|SUPERIORITY_OR_OTHER|||||||0.068|TWO_SIDED||||||Wilcoxon Rank Sum Test|||CR or PR Versus PD||||0.0680
72417854|NCT00338884|144346140|SUPERIORITY_OR_OTHER|||||||0.1159|TWO_SIDED||||||Wilcoxon Rank Sum Test|||CR or PR or (SD \> = 12 Weeks) Versus PD||||0.1159
72417855|NCT00338884|144346142|SUPERIORITY_OR_OTHER|||||||0.8519|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 3 (CR or PR Versus PD)||||0.8519
72417856|NCT00338884|144346142|SUPERIORITY_OR_OTHER|||||||0.5879|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 5 (CR or PR Versus PD)||||0.5879
72417857|NCT00338884|144346142|SUPERIORITY_OR_OTHER|||||||0.4757|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 7 (CR or PR Versus PD)||||0.4757
72417858|NCT00338884|144346142|SUPERIORITY_OR_OTHER|||||||0.1933|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 9 (CR or PR Versus PD)||||0.1933
72417859|NCT00338884|144346142|SUPERIORITY_OR_OTHER|||||||0.4187|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 13 (CR or PR Versus PD)||||0.4187
72325685|NCT03181971|144174963|SUPERIORITY||Odds Ratio (OR)|1.0||||0.98|TWO_SIDED|95.0|0.1|7.0|||Mixed Models Analysis|||Analysis of between group change from baseline to 15 months.||7.0|0.1|.98
72417860|NCT00338884|144346142|SUPERIORITY_OR_OTHER|||||||0.3795|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 17 (CR or PR Versus PD)||||0.3795
72417861|NCT00338884|144346142|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 21 (CR or PR Versus PD)||||1.0000
72417862|NCT00338884|144346142|SUPERIORITY_OR_OTHER|||||||0.6333|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 25 (CR or PR Versus PD)||||0.6333
72417863|NCT00338884|144346142|SUPERIORITY_OR_OTHER|||||||0.8679|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 29 (CR or PR Versus PD)||||0.8679
72417864|NCT00338884|144346142|SUPERIORITY_OR_OTHER|||||||0.592|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 33 (CR or PR Versus PD)||||0.5920
72417865|NCT00338884|144346143|SUPERIORITY_OR_OTHER|||||||0.6939|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 3 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)||||0.6939
72417866|NCT00338884|144346143|SUPERIORITY_OR_OTHER|||||||0.5871|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 5 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)||||0.5871
72417867|NCT00338884|144346143|SUPERIORITY_OR_OTHER|||||||0.4572|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 7 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)||||0.4572
72417868|NCT00338884|144346143|SUPERIORITY_OR_OTHER|||||||0.112|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 9 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)||||0.1120
72417869|NCT00338884|144346143|SUPERIORITY_OR_OTHER|||||||0.4896|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 13 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)||||0.4896
72417870|NCT00338884|144346143|SUPERIORITY_OR_OTHER|||||||0.2369|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 17 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)||||0.2369
72417871|NCT00338884|144346143|SUPERIORITY_OR_OTHER|||||||0.6709|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 21 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)||||0.6709
72417872|NCT00338884|144346143|SUPERIORITY_OR_OTHER|||||||0.6382|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 25 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)||||0.6382
72417873|NCT00338884|144346143|SUPERIORITY_OR_OTHER|||||||0.8481|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 29 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)||||0.8481
72417874|NCT00338884|144346143|SUPERIORITY_OR_OTHER|||||||0.3731|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 33 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)||||0.3731
72417875|NCT00338884|144346145|SUPERIORITY_OR_OTHER|||||||0.0292|TWO_SIDED||||||Wilcoxon Rank Sum Test|||CR or PR Versus PD||||0.0292
72417876|NCT00338884|144346146|SUPERIORITY_OR_OTHER|||||||0.1087|TWO_SIDED||||||Wilcoxon Rank Sum Test|||CR or PR or (SD \> = 12 Weeks) Versus PD||||0.1087
72417877|NCT00338884|144346148|SUPERIORITY_OR_OTHER|||||||0.3386|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 3 (CR or PR Versus PD)||||0.3386
72417878|NCT00338884|144346148|SUPERIORITY_OR_OTHER|||||||0.1949|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 5 (CR or PR Versus PD)||||0.1949
72417879|NCT00338884|144346148|SUPERIORITY_OR_OTHER|||||||0.7037|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 7 (CR or PR Versus PD)||||0.7037
72417880|NCT00338884|144346148|SUPERIORITY_OR_OTHER|||||||0.5748|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 9 (CR or PR Versus PD)||||0.5748
72417881|NCT00338884|144346148|SUPERIORITY_OR_OTHER|||||||0.747|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 13 (CR or PR Versus PD)||||0.7470
72417882|NCT00338884|144346148|SUPERIORITY_OR_OTHER|||||||0.4703|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 17 (CR or PR Versus PD)||||0.4703
72417883|NCT00338884|144346148|SUPERIORITY_OR_OTHER|||||||0.8162|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 21 (CR or PR Versus PD)||||0.8162
72417884|NCT00338884|144346148|SUPERIORITY_OR_OTHER|||||||0.5465|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 25 (CR or PR Versus PD)||||0.5465
72417885|NCT00338884|144346148|SUPERIORITY_OR_OTHER|||||||0.3495|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 29 (CR or PR Versus PD)||||0.3495
72417886|NCT00338884|144346148|SUPERIORITY_OR_OTHER|||||||0.6397|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 33 (CR or PR Versus PD)||||0.6397
72417887|NCT00338884|144346149|SUPERIORITY_OR_OTHER|||||||0.4632|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 3 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)||||0.4632
72325686|NCT03181971|144174964|SUPERIORITY||Adjusted mean difference|0.2||||0.57|TWO_SIDED|95.0|-0.6|1.0|||Mixed Models Analysis|||Analysis of between group change from baseline to 7 months.||1.0|-0.6|0.57
72325687|NCT03181971|144174964|SUPERIORITY||Adjusted mean difference|-0.5||||0.4|TWO_SIDED|95.0|-1.5|0.6|||Mixed Models Analysis|||Analysis of between group change from baseline to 15 months.||0.6|-1.5|.40
72325688|NCT03181971|144174965|SUPERIORITY||Adjusted mean difference|0.04||||0.46|TWO_SIDED|95.0|-0.06|0.1|||Mixed Models Analysis|||Analysis of between group change from baseline to 7 months.||0.1|-0.06|.46
72325689|NCT03181971|144174965|SUPERIORITY||Adjusted mean difference|-0.02||||0.8|TWO_SIDED|95.0|-0.2|0.1|||Mixed Models Analysis|||Analysis of between group change from baseline to 15 months.||0.1|-0.2|.80
72325690|NCT03181971|144174966|SUPERIORITY||Adjusted mean difference|0.001||||0.93|TWO_SIDED|95.0|-0.03|0.03|||Mixed Models Analysis|||Analysis of between group change from baseline to 7 months.||0.03|-0.03|.93
72325691|NCT03181971|144174966|SUPERIORITY||Adjusted mean difference|-0.02||||0.36|TWO_SIDED|95.0|-0.06|0.02|||Mixed Models Analysis|||Analysis of between group change from baseline to 15 months.||0.02|-0.06|.36
72417888|NCT00338884|144346149|SUPERIORITY_OR_OTHER|||||||0.1701|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 5 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)||||0.1701
72325692|NCT03181971|144174967|SUPERIORITY||Percent difference in change|1.4||||0.7|TWO_SIDED|95.0|-5.3|8.5||Because of skewed distributions, dietary outcomes were log-transformed and regression coefficients were exponentiated to derive the percent change in outcomes by intervention status over time.|Mixed Models Analysis|||Analysis of between group change in total kcal intake from baseline to 7 months.||8.5|-5.3|0.70
72325693|NCT03181971|144174967|SUPERIORITY||Percent difference in change|3.7||||0.35|TWO_SIDED|95.0|-3.9|12.0||Because of skewed distributions, dietary outcomes were log-transformed and regression coefficients were exponentiated to derive the percent change in outcomes by intervention status over time.|Mixed Models Analysis|||Analysis of between group change in intake of food kcal from baseline to 7 months.||12.0|-3.9|.35
72325694|NCT03181971|144174967|SUPERIORITY||Percent difference in change|-10.6||||0.35|TWO_SIDED|95.0|-29.2|8.8|||Mixed Models Analysis|||Analysis of between group change in intake of beverage kcal from baseline to 7 months.||8.8|-29.2|.35
72325695|NCT03181971|144174967|SUPERIORITY||Percent difference in change|-17.5||||0.18|TWO_SIDED|95.0|-37.8|9.6|||Mixed Models Analysis|||Analysis of between group change in SSB kcal from baseline to 7 months.||9.6|-37.8|.18
72325696|NCT03181971|144174968|SUPERIORITY||Percent difference in change|9.1||||0.59|TWO_SIDED|95.0|-20.6|49.9||Because of skewed distributions, dietary outcomes were log-transformed and regression coefficients were exponentiated to derive the percent change in outcomes by intervention status over time.|Mixed Models Analysis|||Analysis of between group change from baseline to 7 months.||49.9|-20.6|.59
72325697|NCT03181971|144174969|SUPERIORITY||Percent difference in change|23.2|||<|0.001|TWO_SIDED|95.0|13.1|34.2|||Mixed Models Analysis|||Analysis of between group change in water intake from baseline to 7 months.||34.2|13.1|<.001
72417889|NCT00338884|144346149|SUPERIORITY_OR_OTHER|||||||0.8204|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 7 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)||||0.8204
72325698|NCT03181971|144174969|SUPERIORITY||Percent difference in change|14.7||||0.004|TWO_SIDED|95.0|4.5|25.9|||Mixed Models Analysis|||Analysis of between group change in water intake from baseline to 15 months.||25.9|4.5|.004
72325699|NCT03181971|144174969|SUPERIORITY||Percent difference in change|-8.0||||0.063|TWO_SIDED|95.0|-15.7|0.4|||Mixed Models Analysis|||Analysis of between group change in SSB intake from baseline to 7 months.||0.4|-15.7|0.063
72325700|NCT03181971|144174969|SUPERIORITY||Percent difference in change|-2.8||||0.56|TWO_SIDED|95.0|-11.7|6.9|||Mixed Models Analysis|||Analysis of between group change in SSB intake from baseline to 15 months.||6.9|-11.7|.56
72325701|NCT03181971|144174969|SUPERIORITY||Percent difference in change|1.2||||0.68|TWO_SIDED|95.0|-4.3|7.0|||Mixed Models Analysis|||Analysis of between group change in juice intake from baseline to 7 months.||7|-4.3|.68
72325702|NCT03181971|144174969|SUPERIORITY||Percent difference in change|-1.4||||0.66|TWO_SIDED|95.0|-7.4|5.0|||Mixed Models Analysis|||Analysis of between group change in juice intake from baseline to 15 months.||5|-7.4|.66
72325703|NCT03181971|144174969|SUPERIORITY||Percent difference in change|-4.0||||0.079|TWO_SIDED|95.0|-8.3|0.5|||Mixed Models Analysis|||Analysis of between group change in flavored milk intake from baseline to 7 months.||0.5|-8.3|0.079
72325704|NCT03181971|144174969|SUPERIORITY||Percent difference in change|-3.0||||0.26|TWO_SIDED|95.0|-8.0|2.3|||Mixed Models Analysis|||Analysis of between group change in flavored milk intake from baseline to 15 months.||2.3|-8.0|.26
72325705|NCT03181971|144174969|SUPERIORITY||Percent difference in change|4.4||||0.2|TWO_SIDED|95.0|-2.2|11.5|||Mixed Models Analysis|||Analysis of between group change in plain milk intake from baseline to 7 months.||11.5|-2.2|.20
72325706|NCT03181971|144174969|SUPERIORITY||Percent difference in change|2.3||||0.51|TWO_SIDED|95.0|-4.4|9.6|||Mixed Models Analysis|||Analysis of between group change in plain milk intake from baseline to 15 months.||9.6|-4.4|.51
72325707|NCT03181971|144174970|SUPERIORITY||Percent difference in change|31.3|||<|0.001|TWO_SIDED|95.0|21.2|42.2|||Mixed Models Analysis|||Analysis of between group change in water intake from water source at lunch from baseline to 7 months.||42.2|21.2|<.001
72325708|NCT03181971|144174970|SUPERIORITY||Percent difference in change|4.9||||0.22|TWO_SIDED|95.0|-3.0|13.5|||Mixed Models Analysis|||Analysis of between group change in water intake from water source during lunch from baseline to 15 months.||13.5|-3.0|.22
72325709|NCT03181971|144174970|SUPERIORITY||Percent difference in change|17.0||||0.02|TWO_SIDED|95.0|2.6|33.3|||Mixed Models Analysis|||Analysis of between group change in water intake from water source at recess from baseline to 7 months.||33.3|2.6|.02
72325710|NCT03181971|144174970|SUPERIORITY||Percent difference in change|4.7||||0.48|TWO_SIDED|95.0|-8.0|19.2|||Mixed Models Analysis|||Analysis of between group change in water intake from water source at recess from baseline to 15 months.||19.2|-8.0|.48
72417890|NCT00338884|144346149|SUPERIORITY_OR_OTHER|||||||0.5162|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 9 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)||||0.5162
72417891|NCT00338884|144346149|SUPERIORITY_OR_OTHER|||||||0.9437|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 13 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)||||0.9437
72417892|NCT00338884|144346149|SUPERIORITY_OR_OTHER|||||||0.4013|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 17 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)||||0.4013
72417893|NCT00338884|144346149|SUPERIORITY_OR_OTHER|||||||0.9595|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 21 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)||||0.9595
72417894|NCT00338884|144346149|SUPERIORITY_OR_OTHER|||||||0.6249|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 25 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)||||0.6249
72417895|NCT00338884|144346149|SUPERIORITY_OR_OTHER|||||||0.3731|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 29 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)||||0.3731
72417896|NCT00338884|144346149|SUPERIORITY_OR_OTHER|||||||0.8263|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 33 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)||||0.8263
72609177|NCT02747927|144747128|OTHER||Vaccine Efficacy (VE)|80.2|||<|0.001|TWO_SIDED|95.0|73.3|85.3||Statistical significance was concluded if the lower bound of the 95% CI for the VE was above 25%. Since the hypotheses was tested in a confirmatory manner at a 2-sided significance level of 5%, the calculated p-value was compared with 0.025.|Cox Proportional Hazard Model|VE and 95% CIs was estimated from Cox proportional hazard model with investigational product as a factor, adjusted for age, and stratified by region.||Assuming true VE of 60% and, virologically confirmed cases of dengue fever induced by any dengue serotype occurring from 30 days post 2nd vaccination (Day 120) until end of Part 1 would provide at least 90% power to rule out vaccine effect of ≤25%.||85.3|73.3|<0.001
72609178|NCT05412134|144747144|OTHER|||||||0.333|||||||Chi-squared|||Repetition adherence||||0.333
72609179|NCT05412134|144747144|OTHER|||||||0.626|||||||Chi-squared|||Session adherence||||0.626
72609180|NCT05412134|144747145|SUPERIORITY|||||||0.416|||||||Wilcoxon (Mann-Whitney)|||||||0.416
72609181|NCT05412134|144747146|SUPERIORITY|||||||0.581|||||||t-test, 2 sided|||||||0.581
72609182|NCT05412134|144747147|SUPERIORITY|||||||0.071|||||||t-test, 2 sided|||||||0.071
72417897|NCT01970982|144346159|SUPERIORITY_OR_OTHER_LEGACY||Geometric LS Mean Ratio|23.09|||<|0.001|TWO_SIDED|95.0|18.41|28.95||The primary endpoints were tested using a multiple testing procedure to preserve the overall alpha level by simultaneously testing the endpoints using a closed procedure with each test performed at an alpha level of 2.5% one sided.|ANCOVA|ANCOVA model on MHBMA levels with product, sex, cigarette consumption, and baseline value as covariates.|LS mean ratio THS 2.2:CC|"The hypothesis to be tested is that the geometric mean level on Day 5 of the biomarker of exposure for THS 2.2 is lower relative to CC.~Analysis of the BoExp was conducted on the natural log scale in order to test the following hypothesis (one sided test with 2.5% type I error probability):~* Null hypothesis (H0): m1≥m2~* Alternative hypothesis (H1): m1\<m2 Where m1 and m2 are the geometric means of the BoExp levels on Day 5 for THS 2.2 and CC respectively."||28.95|18.41|<0.001
72609183|NCT05412134|144747148|SUPERIORITY|||||||0.356|||||||t-test, 2 sided|||||||0.356
72609184|NCT05412134|144747150|SUPERIORITY|||||||0.079|||||||t-test, 2 sided|||||||0.079
72609185|NCT04275336|144747153|OTHER||H value|1.344||||0.511|TWO_SIDED|95.0||||\<0.05|Kruskal-Wallis|||||||0.511
72609186|NCT04275336|144747154|OTHER||H value|5.272||||0.072|TWO_SIDED|95.0||||\<0.05|Kruskal-Wallis|||||||0.072
72609187|NCT04275336|144747155|OTHER||H value|0.198||||0.906|ONE_SIDED|95.0||||\<0.05|Kruskal-Wallis|||||||0.906
72609188|NCT04275336|144747156|OTHER||H value|6.679||||0.035|TWO_SIDED|95.0||||\<0.05|Kruskal-Wallis|||||||0.035
72609189|NCT04275336|144747157|OTHER||Mean Difference (Final Values)|0.17||||0.844|TWO_SIDED|95.0||||\<0.05|ANOVA|||||||0.844
72609190|NCT04275336|144747158|OTHER||H value|1.651||||0.438|TWO_SIDED|95.0||||\<0.05|Kruskal-Wallis|||||||0.438
72609191|NCT04275336|144747159|OTHER||H value|0.341||||0.843|TWO_SIDED|95.0||||\<0.05|Kruskal-Wallis|||||||0.843
72609192|NCT04275336|144747160|OTHER||Median Difference (Final Values)|1.642||||0.44|TWO_SIDED|95.0||||\<0.05|Kruskal-Wallis|||||||0.440
72609193|NCT04664205|144747164|SUPERIORITY|||||||0.01|||||||t-test, 2 sided|||||||0.010
72609194|NCT04664205|144747165|SUPERIORITY|||||||0.069|||||||ANCOVA|||||||0.069
72609195|NCT04664205|144747166|SUPERIORITY|||||||0.478|||||||ANOVA|||||||0.478
72609196|NCT01578772|144747172|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.0|||<|0.05|TWO_SIDED|95.0|-0.1|0.1|||Wilcoxon (Mann-Whitney)|Pairwise comparisons were performed using Wilcoxon signed rank test. All statistical tests are two-sided with nominal alpha level of 0.05.||||0.1|-0.1|<0.05
72609197|NCT01578772|144747173|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.7|||<|0.05|TWO_SIDED|95.0|-1.3|1.9|||Wilcoxon (Mann-Whitney)|Pairwise comparisons were performed using Wilcoxon signed rank test. All statistical tests are two-sided with nominal alpha level of 0.05.||||1.9|-1.3|<0.05
72609198|NCT00808340|144747239|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin = -0.5.|Mean Difference (Final Values)|-0.1249|STANDARD_ERROR_OF_MEAN|0.1464|||TWO_SIDED|97.5|-0.4143|0.1644|||Mixed Models Analysis||Mean difference is calculated as senofilcon A multifocal prod minus senofilcon A multifocal test.|Alternative hypothesis is that senofilcon A multifocal prod is non-inferior to senofilcon A multifocal test.||0.1644|-0.4143|
72609199|NCT00808340|144747239|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin = -0.5|Mean Difference (Final Values)|-0.3693|STANDARD_ERROR_OF_MEAN|0.1464|||TWO_SIDED|97.5|-0.6587|-0.07996|||Mixed Models Analysis||The mean difference was calculated as balafilcon A multifocal minus senofilcon A multifocal prod.|Alternative hypothesis is that senofilcon A multifocal prod is non-inferior to balafilcon A multifocal.||-0.07996|-0.6587|
72609200|NCT00808340|144747240|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin = -0.5|Mean Difference (Final Values)|-0.04083|STANDARD_ERROR_OF_MEAN|0.1464|||TWO_SIDED|97.5|-0.2485|0.3302|||Mixed Models Analysis||The mean difference is calculated as senofilcon A multifocal prod minus senofilcon A multifocal test.|Alternative hypothesis is that senofilcon A multifocal prod is non-inferior to senofilcon A multifocal test.||0.3302|-0.2485|
72421639|NCT03815019|144354429|SUPERIORITY||Odds Ratio, log|9.1544|STANDARD_ERROR_OF_MEAN|13083.0|||TWO_SIDED||||||||Participants in the placebo group who successfully transitioned to oral feeding.|Analysis conducted using Generalized Linear Mixed Models with a logit link within SAS Proc GLIMMIX to model the binary outcome of transitioned to oral feeding (y/n) defined as at least 90 percent of calories consumed orally. Fixed effects (dummy variables) will be entered for each site as described by McNeish and Stapleton (2016) to account for the clustering of the participants within sites. This will result in essentially, a logistic regression model with appropriate standard errors.||||
72609201|NCT00808340|144747240|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin = -0.5|Mean Difference (Final Values)|-0.4608|STANDARD_ERROR_OF_MEAN|0.1464|||TWO_SIDED|97.5|-0.7502|-0.1714|||Mixed Models Analysis||The mean difference was calculated as senofilcon A multifocal prod minus balafilcon A multifocal.|Alternative hypothesis is that senofilcon A multifocal prod is non-inferior to balafilcon A multifocal.||-0.1714|-0.7502|
72609202|NCT00808340|144747241|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin = 0.5|Mean Difference (Final Values)|-0.02941|STANDARD_ERROR_OF_MEAN|0.02656|||TWO_SIDED|97.5|-0.08153|0.02271|||Mixed Models Analysis||The mean difference is calculated as senofilcon A multifocal prod minus senofilcon A multifocal test.|Alternative hypothesis is senofilcon A multifocal prod is non-inferior to senofilcon A multifocal test.||0.02271|-0.08153|
72609203|NCT00808340|144747241|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin = 0.5|Mean Difference (Final Values)|-0.06765|STANDARD_ERROR_OF_MEAN|0.02656|||TWO_SIDED|97.5|-0.1198|-0.01553|||Mixed Models Analysis||The mean difference is calculated as senfilcon A multifocal prod minus balafilcon A multifocal.|Alternative hypothesis is senofilcon A multifocal prod is non-inferior to balafilcon A multifocal.||-0.01553|-0.1198|
72609204|NCT00808340|144747242|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin = -0.5|Mean Difference (Final Values)|-0.3304|STANDARD_ERROR_OF_MEAN|0.2243|||TWO_SIDED|97.5|-0.779|0.1183|||Mixed Models Analysis||The mean difference is calculated as senofilcon A multifocal prod minus senofilcon A multifocal test.|Alternative hyposthesis is that senofilcon A multifocal prod is non-inferior to senofilcon A multifocal test.||0.1183|-0.779|
72609205|NCT00808340|144747242|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin = -0.5|Mean Difference (Final Values)|-0.2281|STANDARD_ERROR_OF_MEAN|0.2243|||TWO_SIDED|97.5|-0.6767|0.2206|||Mixed Models Analysis||The mean difference is calculated as senofilcon A multifocal prod minus balafilcon A multifocal.|Alternativie hypothesis is that senofilcon A multifocal prod is non-inferior to balafilcon A multifocal.||0.2206|-0.6767|
72609206|NCT02175121|144747253|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-40.33|STANDARD_ERROR_OF_MEAN|6.75|<|0.0001|TWO_SIDED|90.0|-51.49|-29.16||Two-sided p-values are from analysis of Covariance (ANCOVA) model with baseline value and treatment group as fixed effects.|ANCOVA|LS mean difference from placebo adjusted for baseline values is derived from the ANCOVA model.||Placebo was the Reference and each of the active doses was the Test.||-29.16|-51.49|<0.0001
72609207|NCT02175121|144747253|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-45.53|STANDARD_ERROR_OF_MEAN|6.98|<|0.0001|TWO_SIDED|90.0|-57.08|-33.99||Two-sided p-values are from analysis of Covariance (ANCOVA) model with baseline value and treatment group as fixed effects.|ANCOVA|LS mean difference from placebo adjusted for baseline values is derived from the ANCOVA model.||Placebo was the Reference and each of the active doses was the Test.||-33.99|-57.08|<0.0001
72609208|NCT02175121|144747253|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-68.79|STANDARD_ERROR_OF_MEAN|6.73|<|0.0001|TWO_SIDED|90.0|-79.92|-57.65||Two-sided p-values are from analysis of Covariance (ANCOVA) model with baseline value and treatment group as fixed effects.|ANCOVA|LS mean difference from placebo adjusted for baseline values is derived from the ANCOVA model.||Placebo was the Reference and each of the active doses was the Test.||-57.65|-79.92|<0.0001
72609209|NCT02175121|144747253|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-68.12|STANDARD_ERROR_OF_MEAN|6.86|<|0.0001|TWO_SIDED|90.0|-79.46|-56.78||Two-sided p-values are from analysis of Covariance (ANCOVA) model with baseline value and treatment group as fixed effects.|ANCOVA|LS mean difference from placebo adjusted for baseline values is derived from the ANCOVA model.||Placebo was the Reference and each of the active doses was the Test.||-56.78|-79.46|<0.0001
72609210|NCT02175121|144747254|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-16.25|STANDARD_ERROR_OF_MEAN|5.83||0.006|TWO_SIDED|90.0|-25.9|-6.6||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 14.||-6.60|-25.90|0.0060
72609211|NCT02175121|144747254|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-26.98|STANDARD_ERROR_OF_MEAN|5.94|<|0.0001|TWO_SIDED|90.0|-36.81|-17.15||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 14.||-17.15|-36.81|<0.0001
72609212|NCT02175121|144747254|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-39.6|STANDARD_ERROR_OF_MEAN|5.8|<|0.0001|TWO_SIDED|90.0|-49.2|-30.0||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 14.||-30.00|-49.20|<0.0001
72609213|NCT02175121|144747254|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-46.72|STANDARD_ERROR_OF_MEAN|5.89|<|0.0001|TWO_SIDED|90.0|-56.46|-36.98||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 14.||-36.98|-56.46|<0.0001
72325711|NCT03181971|144174970|SUPERIORITY||Percent difference in change|34.6||||0.14|TWO_SIDED|95.0|-9.4|99.8|||Mixed Models Analysis|||Analysis of between group change in water intake from water source at PE from baseline to 7 months.||99.8|-9.4|.14
72325712|NCT03181971|144174970|SUPERIORITY||Percent difference in change|32.1||||0.16|TWO_SIDED|95.0|-11.0|96.2|||Mixed Models Analysis|||Analysis of between group change in water intake from water source at PE from baseline to 15 months.||96.2|-11.0|.16
72421640|NCT03815019|144354431|SUPERIORITY||Mean Difference (Final Values)|0.08|||||TWO_SIDED||||||||Pr(\>F) = 0.7846, Nested model using site as a predictor|||||
72325713|NCT01772550|144174972|NON_INFERIORITY_OR_EQUIVALENCE|A 95% upper confidence bound for the observed difference in percentages of images with acceptable quality between the control catheter and evaluation catheter was calculated using the Score method. The 20 G BD Nexiva™ Diffusics™ can be considered non-inferior for acceptable image quality if this 95% upper confidence bound is smaller than 15% (i.e. C - D \< 15% with 95% confidence). The non-inferiority margin was 15%.|Risk Difference (RD)|0.0|||||ONE_SIDED|95.0||2.6|||||The difference in percent of acceptable image quality is used as an estimate. The Score method was used to estimate the upper 95% confidence limit.|Only the percent of acceptable image quality from the randomized test and reference catheter groups were considered for this statistical analysis. If C is the percentage of acceptable quality images with the control catheter, and D is the percentage of images of acceptable quality with the evaluation catheter, and the non-inferiority criteria is 15%, the hypotheses to be tested are as follows: H0: C - D \> or = 15%; H1: C - D \< 15%.||2.6||
72325714|NCT01127633|144175014|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The noninferiority margin for this hypothesis was specified as 50% of the treatment difference observed at the end of the feeder study. If the lower limit of the confidence interval (CI) was greater than 0, the noninferiority criterion was met, indicating that at least 50% of the treatment difference observed at the end of the feeder studies was maintained at specified time points in the delayed-start period.|Median Difference (Net)|-0.02||||0.974|TWO_SIDED|95.0|-1.14|1.11|||Mixed Models Analysis|||||1.11|-1.14|0.974
72325715|NCT00688467|144175026|SUPERIORITY_OR_OTHER||100 * (placebo - navarixin) / placebo|26.0|STANDARD_DEVIATION|27.377||0.411|||||||ANOVA|||||||0.411
72325716|NCT00688467|144175027|SUPERIORITY_OR_OTHER||100 * (placebo - navarixin) / placebo|23.3|STANDARD_DEVIATION|0.306||0.292|||||||ANOVA|||||||0.292
72325717|NCT00688467|144175029|SUPERIORITY_OR_OTHER||100 * (placebo - navarixin) / placebo|-1.7|STANDARD_DEVIATION|16.261||0.927|||||||ANOVA|||||||0.927
72325718|NCT00688467|144175030|SUPERIORITY_OR_OTHER||100 * (placebo - navarixin) / placebo|4.3|STANDARD_DEVIATION|7.398||0.645|||||||ANOVA|||||||0.645
72609214|NCT02175121|144747254|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-27.07|STANDARD_ERROR_OF_MEAN|5.33|<|0.0001|TWO_SIDED|90.0|-35.89|-18.25||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 28.||-18.25|-35.89|<0.0001
72609215|NCT02175121|144747254|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-36.18|STANDARD_ERROR_OF_MEAN|5.46|<|0.0001|TWO_SIDED|90.0|-45.21|-27.14||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 28.||-27.14|-45.21|<0.0001
72325719|NCT02163577|144175042|SUPERIORITY||||||<|0.0001||||||Per generalized estimating equations (GEE) model, which included visit, regimen, visit by regimen as factors, and RSS total score at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 40||||< 0.0001
72325720|NCT02163577|144175042|SUPERIORITY||||||<|0.0001||||||Per GEE model, which included visit, regimen, visit by regimen as factors, and RSS total score at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 40||||< 0.0001
72325721|NCT02163577|144175042|SUPERIORITY||Difference in LS Means|-0.33|||||TWO_SIDED|95.0|-0.63|-0.04||||||Difference in change to Week 40||-0.04|-0.63|
72325722|NCT02163577|144175042|SUPERIORITY||||||<|0.0001||||||Per GEE model, which included visit, regimen, visit by regimen as factors, and RSS total score at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 64||||< 0.0001
72609216|NCT02175121|144747254|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-51.47|STANDARD_ERROR_OF_MEAN|5.33|<|0.0001|TWO_SIDED|90.0|-60.29|-42.65||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 28.||-42.65|-60.29|<0.0001
72609217|NCT02175121|144747254|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-57.17|STANDARD_ERROR_OF_MEAN|5.41|<|0.0001|TWO_SIDED|90.0|-66.12|-48.22||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 28.||-48.22|-66.12|<0.0001
72325723|NCT02163577|144175042|SUPERIORITY||||||<|0.0001||||||Per GEE model, which included visit, regimen, visit by regimen as factors, and RSS total score at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 64||||< 0.0001
72325724|NCT02163577|144175042|SUPERIORITY||Difference in LS Means|-0.16|||||TWO_SIDED|95.0|-0.45|0.13||||||Difference in change to Week 64||0.13|-0.45|
72325725|NCT02163577|144175042|SUPERIORITY||||||<|0.0001||||||Per GEE model, which included visit, regimen, visit by regimen as factors, and RSS total score at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 160||||< 0.0001
72325726|NCT02163577|144175042|SUPERIORITY||||||<|0.0001||||||Per GEE model, which included visit, regimen, visit by regimen as factors, and RSS total score at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 160||||< 0.0001
72325727|NCT02163577|144175043|SUPERIORITY||||||<|0.0001|||||||one sample t test|||Week 40||||< 0.0001
72325728|NCT02163577|144175043|SUPERIORITY||||||<|0.0001|||||||one sample t test|||Week 40||||< 0.0001
72325729|NCT02163577|144175043|SUPERIORITY||||||<|0.0001|||||||one sample t test|||Week 64||||< 0.0001
72325730|NCT02163577|144175043|SUPERIORITY||||||<|0.0001|||||||one sample t test|||Week 64||||< 0.0001
72325731|NCT02163577|144175043|SUPERIORITY||||||<|0.0001|||||||one sample t test|||Week 160||||< 0.0001
72325732|NCT02163577|144175043|SUPERIORITY||||||<|0.0001|||||||one sample t test|||Week 160||||< 0.0001
72325733|NCT02163577|144175044|SUPERIORITY||||||<|0.0001|||||||one sample t test|||Week 40||||< 0.0001
72325734|NCT02163577|144175044|SUPERIORITY||||||<|0.0001|||||||one sample t test|||Week 40||||< 0.0001
72325735|NCT02163577|144175044|SUPERIORITY||||||<|0.0001|||||||one sample t test|||Week 64||||< 0.0001
72325736|NCT02163577|144175044|SUPERIORITY|||||||0.0024|||||||one sample t test|||Week 64||||0.0024
72609218|NCT02175121|144747255|SUPERIORITY_OR_OTHER||Mean Difference (Net)|12.86|STANDARD_ERROR_OF_MEAN|10.13||0.2063|TWO_SIDED|90.0|-3.91|29.62||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day, statin use and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 14.||29.62|-3.91|0.2063
72609219|NCT02175121|144747255|SUPERIORITY_OR_OTHER||Mean Difference (Net)|13.03|STANDARD_ERROR_OF_MEAN|10.33||0.2087|TWO_SIDED|90.0|-4.05|30.11||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day, statin use and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 14.||30.11|-4.05|0.2087
72609220|NCT02175121|144747255|SUPERIORITY_OR_OTHER||Mean Difference (Net)|5.6|STANDARD_ERROR_OF_MEAN|10.1||0.5802|TWO_SIDED|90.0|-11.11|22.3||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day, statin use and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 14.||22.30|-11.11|0.5802
72609221|NCT02175121|144747255|SUPERIORITY_OR_OTHER||Mean Difference (Net)|14.64|STANDARD_ERROR_OF_MEAN|10.25||0.1553|TWO_SIDED|90.0|-2.32|31.59||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day, statin use and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 14.||31.59|-2.32|0.1553
72609222|NCT02175121|144747255|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.2|STANDARD_ERROR_OF_MEAN|7.66||0.7741|TWO_SIDED|90.0|-14.87|10.47||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day, statin use and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 28.||10.47|-14.87|0.7741
72609223|NCT02175121|144747255|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.4|STANDARD_ERROR_OF_MEAN|7.78||0.9588|TWO_SIDED|90.0|-13.28|12.47||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day, statin use and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 28.||12.47|-13.28|0.9588
72609224|NCT02175121|144747255|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.42|STANDARD_ERROR_OF_MEAN|7.61||0.8523|TWO_SIDED|90.0|-11.17|14.01||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day, statin use and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 28.||14.01|-11.17|0.8523
72609225|NCT02175121|144747255|SUPERIORITY_OR_OTHER||Mean Difference (Net)|6.3|STANDARD_ERROR_OF_MEAN|7.73||0.4166|TWO_SIDED|90.0|-6.49|19.08||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day, statin use and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 28.||19.08|-6.49|0.4166
72609226|NCT02175121|144747256|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.6|STANDARD_ERROR_OF_MEAN|3.22||0.8516|TWO_SIDED|90.0|-4.73|5.93||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day, statin use and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 14.||5.93|-4.73|0.8516
72609227|NCT02175121|144747256|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.97|STANDARD_ERROR_OF_MEAN|3.29||0.2303|TWO_SIDED|90.0|-1.48|9.42||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day, statin use and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 14.||9.42|-1.48|0.2303
72609228|NCT02175121|144747256|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.19|STANDARD_ERROR_OF_MEAN|3.22||0.7132|TWO_SIDED|90.0|-4.15|6.52||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day, statin use and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 14.||6.52|-4.15|0.7132
72609229|NCT02175121|144747256|SUPERIORITY_OR_OTHER||Mean Difference (Net)|9.74|STANDARD_ERROR_OF_MEAN|3.28||0.0034|TWO_SIDED|90.0|4.32|15.16||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day, statin use and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 14.||15.16|4.32|0.0034
72609230|NCT02175121|144747256|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.99|STANDARD_ERROR_OF_MEAN|2.96||0.7394|TWO_SIDED|90.0|-5.89|3.92||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day, statin use and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 28.||3.92|-5.89|0.7394
72609231|NCT02175121|144747256|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.52|STANDARD_ERROR_OF_MEAN|3.03||0.8652|TWO_SIDED|90.0|-4.5|5.53||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day, statin use and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 28.||5.53|-4.50|0.8652
72421641|NCT03815019|144354432|SUPERIORITY||Mean Difference (Final Values)|0.15|||||TWO_SIDED||||||||Pr(\>F) = 0.7025, Nested model using site as a predictor|||||
72421642|NCT03815019|144354433|SUPERIORITY||Mean Difference (Final Values)|0.18|||||TWO_SIDED||||||||Pr(\>F) = 0.6764, Nested model using site as a predictor|||||
72609232|NCT02175121|144747256|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.61|STANDARD_ERROR_OF_MEAN|2.97||0.837|TWO_SIDED|90.0|-4.3|5.52||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day, statin use and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 28.||5.52|-4.30|0.8370
72609233|NCT02175121|144747256|SUPERIORITY_OR_OTHER||Mean Difference (Net)|9.59|STANDARD_ERROR_OF_MEAN|3.01||0.0018|TWO_SIDED|90.0|4.6|14.58||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day, statin use and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 28.||14.58|4.60|0.0018
72609234|NCT02175121|144747257|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.12|STANDARD_ERROR_OF_MEAN|4.25||0.6182|TWO_SIDED|90.0|-9.15|4.91||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day, statin use and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 14.||4.91|-9.15|0.6182
72609235|NCT02175121|144747257|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.66|STANDARD_ERROR_OF_MEAN|4.34||0.7028|TWO_SIDED|90.0|-5.52|8.84||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day, statin use and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 14.||8.84|-5.52|0.7028
72325737|NCT02163577|144175044|SUPERIORITY|||||||0.0018|||||||one sample t test|||Week 160||||0.0018
72325738|NCT02163577|144175044|SUPERIORITY|||||||0.0002|||||||one sample t test|||Week 160||||0.0002
72421643|NCT03815019|144354434|SUPERIORITY||Mean Difference (Final Values)|0.09|||||TWO_SIDED||||||||Pr(\>F) = 0.7649, Nested model using site as a predictor|||||
72421644|NCT03815019|144354435|SUPERIORITY||Mean Difference (Final Values)|0.0|||||TWO_SIDED||||||||Pr(\>F) = 0.9487, Nested model using site as a predictor|||||
72421645|NCT03815019|144354436|SUPERIORITY||Mean Difference (Final Values)|0.09|||||TWO_SIDED||||||||Pr(\>F) = 0.7669, Nested model using site as a predictor|||||
72609236|NCT02175121|144747257|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.3|STANDARD_ERROR_OF_MEAN|4.25||0.9445|TWO_SIDED|90.0|-7.33|6.73||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day, statin use and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 14.||6.73|-7.33|0.9445
72417898|NCT01970982|144346160|SUPERIORITY_OR_OTHER_LEGACY||Geometric LS Mean Ratio|52.86|||<|0.001|TWO_SIDED|95.0|45.67|61.17||The primary endpoints were tested using a multiple testing procedure to preserve the overall alpha level by simultaneously testing the endpoints using a closed procedure with each test performed at an alpha level of 2.5% one sided.|ANCOVA|ANCOVA model on 3-HPMA levels with product, sex, cigarette consumption, and baseline value as covariates.|LS mean ratio THS 2.2:CC|"The hypothesis to be tested is that the geometric mean level on Day 5 of the biomarker of exposure for THS 2.2 is lower relative to CC.~Analysis of the BoExp was conducted on the natural log scale in order to test the following hypothesis (one sided test with 2.5% type I error probability):~* Null hypothesis (H0): m1≥m2~* Alternative hypothesis (H1): m1\<m2 Where m1 and m2 are the geometric means of the BoExp levels on Day 5 for THS 2.2 and CC respectively."||61.17|45.67|<0.001
72417899|NCT01970982|144346161|SUPERIORITY_OR_OTHER_LEGACY||Geometric LS Mean Ratio|15.68|||<|0.001|TWO_SIDED|95.0|13.09|18.78||The primary endpoints were tested using a multiple testing procedure to preserve the overall alpha level by simultaneously testing the endpoints using a closed procedure with each test performed at an alpha level of 2.5% one sided.|ANCOVA|ANCOVA model on S-PMA levels with product, sex, cigarette consumption, and baseline value as covariates.|LS mean ratio THS 2.2:CC|"The hypothesis to be tested is that the geometric mean level on Day 5 of the biomarker of exposure for THS 2.2 is lower relative to CC.~Analysis of the BoExp was conducted on the natural log scale in order to test the following hypothesis (one sided test with 2.5% type I error probability):~* Null hypothesis (H0): m1≥m2~* Alternative hypothesis (H1): m1\<m2 Where m1 and m2 are the geometric means of the BoExp levels on Day 5 for THS 2.2 and CC respectively."||18.78|13.09|<0.001
72421646|NCT03815019|144354437|SUPERIORITY||Mean Difference (Final Values)|0.3|||||TWO_SIDED||||||||Pr(\>F) = 0.5883, Nested model using site as a predictor|||||
72421647|NCT03815019|144354438|SUPERIORITY||Mean Difference (Final Values)|0.52|||||TWO_SIDED||||||||Pr(\>F) = 0.4749, Nested model using site as a predictor|||||
72325739|NCT02163577|144175045|SUPERIORITY||||||<|0.0001|||||||one sample t test|||Week 40||||< 0.0001
72421648|NCT03815019|144354439|SUPERIORITY||Mean Difference (Final Values)|0.02|||||TWO_SIDED||||||||Pr(\>F) = 0.8781, Nested model using site as a predictor|||||
72609237|NCT02175121|144747257|SUPERIORITY_OR_OTHER||Mean Difference (Net)|9.07|STANDARD_ERROR_OF_MEAN|4.32||0.0373|TWO_SIDED|90.0|1.93|16.21||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day, statin use and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 14.||16.21|1.93|0.0373
72609238|NCT02175121|144747257|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.29|STANDARD_ERROR_OF_MEAN|4.21||0.9448|TWO_SIDED|90.0|-7.25|6.67||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day, statin use and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 28.||6.67|-7.25|0.9448
72609239|NCT02175121|144747257|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.37|STANDARD_ERROR_OF_MEAN|4.3||0.9312|TWO_SIDED|90.0|-6.74|7.49||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day, statin use and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 28.||7.49|-6.74|0.9312
72609240|NCT02175121|144747257|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.11|STANDARD_ERROR_OF_MEAN|4.21||0.9791|TWO_SIDED|90.0|-7.07|6.85||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day, statin use and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 28.||6.85|-7.07|0.9791
72609241|NCT02175121|144747257|SUPERIORITY_OR_OTHER||Mean Difference (Net)|12.34|STANDARD_ERROR_OF_MEAN|4.28||0.0044|TWO_SIDED|90.0|5.26|19.41||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day, statin use and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 28.||19.41|5.26|0.0044
72609242|NCT02175121|144747258|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.77|STANDARD_ERROR_OF_MEAN|3.96||0.6553|TWO_SIDED|90.0|-4.78|8.33||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day, statin use and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 14.||8.33|-4.78|0.6553
72609243|NCT02175121|144747258|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.61|STANDARD_ERROR_OF_MEAN|4.05||0.2569|TWO_SIDED|90.0|-2.09|11.3||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day, statin use and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 14.||11.30|-2.09|0.2569
72609244|NCT02175121|144747258|SUPERIORITY_OR_OTHER||Mean Difference (Net)|7.64|STANDARD_ERROR_OF_MEAN|3.96||0.0553|TWO_SIDED|90.0|1.09|14.18||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day, statin use and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 14.||14.18|1.09|0.0553
72609245|NCT02175121|144747258|SUPERIORITY_OR_OTHER||Mean Difference (Net)|12.89|STANDARD_ERROR_OF_MEAN|4.01||0.0016|TWO_SIDED|90.0|6.26|19.53||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day, statin use and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 14.||19.53|6.26|0.0016
72609246|NCT02175121|144747258|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.58|STANDARD_ERROR_OF_MEAN|3.58||0.8717|TWO_SIDED|90.0|-5.35|6.51||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day, statin use and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 28.||6.51|-5.35|0.8717
72609247|NCT02175121|144747258|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.2|STANDARD_ERROR_OF_MEAN|3.66||0.743|TWO_SIDED|90.0|-4.86|7.26||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day, statin use and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 28.||7.26|-4.86|0.7430
72609248|NCT02175121|144747258|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.56|STANDARD_ERROR_OF_MEAN|3.58||0.2041|TWO_SIDED|90.0|-1.36|10.48||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day, statin use and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 28.||10.48|-1.36|0.2041
72609249|NCT02175121|144747258|SUPERIORITY_OR_OTHER||Mean Difference (Net)|14.92|STANDARD_ERROR_OF_MEAN|3.63|<|0.0001|TWO_SIDED|90.0|8.92|20.92||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day, statin use and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 28.||20.92|8.92|<0.0001
72325740|NCT02163577|144175045|SUPERIORITY||||||<|0.0001|||||||one sample t test|||Week 40||||< 0.0001
72325741|NCT02163577|144175045|SUPERIORITY||||||<|0.0001|||||||one sample t test|||Week 64||||< 0.0001
72325742|NCT02163577|144175045|SUPERIORITY||||||<|0.0001|||||||one sample t test|||Week 64||||< 0.0001
72325743|NCT02163577|144175045|SUPERIORITY||||||<|0.0001|||||||one sample t test|||Week 160||||< 0.0001
72325744|NCT02163577|144175045|SUPERIORITY||||||<|0.0001|||||||one sample t test|||Week 160||||< 0.0001
72421649|NCT00532155|144354440|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.01||||0.8985|TWO_SIDED|95.0|0.868|1.174|||Stratified log-rank test|Stratified on ECOG Performance Status (0 vs 1 vs 2) and Prior Bevacizumab (yes vs no) according to IVRS.||||1.174|0.868|0.8985
72609250|NCT02175121|144747259|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.13|STANDARD_ERROR_OF_MEAN|4.08||0.975|TWO_SIDED|90.0|-6.62|6.87||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day, statin use and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 14.||6.87|-6.62|0.9750
72325745|NCT02163577|144175046|SUPERIORITY||||||<|0.0001||||||ANCOVA model includes the change from baseline in RSS as the dependent variable, regimen group as factor, and RSS at baseline as covariate.|ANCOVA|||Week 40||||< 0.0001
72325746|NCT02163577|144175046|SUPERIORITY||||||<|0.0001||||||ANCOVA model includes the change from baseline in RSS as the dependent variable, regimen group as factor, and RSS at baseline as covariate.|ANCOVA|||Week 40||||< 0.0001
72325747|NCT02163577|144175046|SUPERIORITY||||||<|0.0001||||||GEE model includes the change from baseline in RSS as the dependent variable, visit, regimen, visit by regimen as factors, and RSS at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 64||||< 0.0001
72325748|NCT02163577|144175046|SUPERIORITY||||||<|0.0001||||||GEE model includes the change from baseline in RSS as the dependent variable, visit, regimen, visit by regimen as factors, and RSS at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 64||||< 0.0001
72325749|NCT02163577|144175046|SUPERIORITY||||||<|0.0001||||||GEE model includes the change from baseline in RSS as the dependent variable, visit, regimen, visit by regimen as factors, and RSS at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 160||||< 0.0001
72325750|NCT02163577|144175046|SUPERIORITY||||||<|0.0001||||||GEE model includes the change from baseline in RSS as the dependent variable, visit, regimen, visit by regimen as factors, and RSS at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 160||||< 0.0001
72325751|NCT02163577|144175047|SUPERIORITY||||||<|0.0001||||||ANCOVA model includes the change from baseline in RSS as the dependent variable, regimen group as factor, and RSS at baseline as covariate.|ANCOVA|||Week 40||||< 0.0001
72325752|NCT02163577|144175047|SUPERIORITY|||||||0.0015||||||ANCOVA model includes the change from baseline in RSS as the dependent variable, regimen group as factor, and RSS at baseline as covariate.|ANCOVA|||Week 40||||0.0015
72325753|NCT02163577|144175047|SUPERIORITY||||||<|0.0001||||||GEE model includes the change from baseline in RSS as the dependent variable, visit, regimen, visit by regimen as factors, and RSS at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 64||||< 0.0001
72325754|NCT02163577|144175047|SUPERIORITY||||||<|0.0001||||||GEE model includes the change from baseline in RSS as the dependent variable, visit, regimen, visit by regimen as factors, and RSS at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 64||||< 0.0001
72325755|NCT02163577|144175047|SUPERIORITY||||||<|0.0001||||||GEE model includes the change from baseline in RSS as the dependent variable, visit, regimen, visit by regimen as factors, and RSS at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 160||||< 0.0001
72325756|NCT02163577|144175047|SUPERIORITY||||||<|0.0001||||||GEE model includes the change from baseline in RSS as the dependent variable, visit, regimen, visit by regimen as factors, and RSS at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 160||||< 0.0001
72609251|NCT02175121|144747259|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.99|STANDARD_ERROR_OF_MEAN|4.16||0.3396|TWO_SIDED|90.0|-2.9|10.87||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day, statin use and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 14.||10.87|-2.90|0.3396
72325757|NCT02163577|144175048|SUPERIORITY||||||<|0.0001||||||ANCOVA model includes RGI-C as the dependent variable, regimen group as factor, and RSS at baseline as covariate.|ANCOVA|||Week 40||||< 0.0001
72325758|NCT02163577|144175048|SUPERIORITY||||||<|0.0001||||||ANCOVA model includes RGI-C as the dependent variable, regimen group as factor, and RSS at baseline as covariate.|ANCOVA|||Week 40||||< 0.0001
72325759|NCT02163577|144175048|SUPERIORITY||Difference in LS Means|0.21|||||TWO_SIDED|95.0|-0.12|0.54||||||Difference in change to Week 40||0.54|-0.12|
72325760|NCT02163577|144175048|SUPERIORITY||||||<|0.0001||||||Per GEE model, which included visit, regimen, visit by regimen as factors, and RSS total score at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 64||||< 0.0001
72609252|NCT02175121|144747259|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.49|STANDARD_ERROR_OF_MEAN|4.07||0.7142|TWO_SIDED|90.0|-8.23|5.24||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day, statin use and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 14.||5.24|-8.23|0.7142
72609253|NCT02175121|144747259|SUPERIORITY_OR_OTHER||Mean Difference (Net)|9.78|STANDARD_ERROR_OF_MEAN|4.14||0.0192|TWO_SIDED|90.0|2.94|16.63||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day, statin use and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 14.||16.63|2.94|0.0192
72609254|NCT02175121|144747259|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.84|STANDARD_ERROR_OF_MEAN|3.85||0.8277|TWO_SIDED|90.0|-7.2|5.52||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day, statin use and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 28.||5.52|-7.20|0.8277
72609255|NCT02175121|144747259|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.57|STANDARD_ERROR_OF_MEAN|3.93||0.8857|TWO_SIDED|90.0|-5.93|7.06||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day, statin use and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 28.||7.06|-5.93|0.8857
72609256|NCT02175121|144747259|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.57|STANDARD_ERROR_OF_MEAN|3.84||0.8824|TWO_SIDED|90.0|-6.93|5.79||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day, statin use and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 28.||5.79|-6.93|0.8824
72609257|NCT02175121|144747259|SUPERIORITY_OR_OTHER||Mean Difference (Net)|9.23|STANDARD_ERROR_OF_MEAN|3.9||0.0192|TWO_SIDED|90.0|2.77|15.69||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day, statin use and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 28.||15.69|2.77|0.0192
72609258|NCT01251042|144747313|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Information about the size of the standard deviation (SD) for the change was obtained from an earlier study. The SD for the change from pre-operation until 24 hours after start of transfusion was 0.2305. Due to the imprecise measuring device (if values below 0.3 g/l) and the large SD, a non-inferiority margin (∆) of 0.2 g/l was decided to be used in this study, resulting in a total number of 42 evaluable subjects, i.e. 21 subjects per group.||||||0.6294||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.6294
72609259|NCT03886272|144747322|OTHER||Adjusted Geometric Mean Ratio (T1/R1)[%]|112.96||||0.0413|TWO_SIDED|90.0|102.7|124.26||P-value for ratio outside 80% -125%.|ANOVA|The model includes fixed effects for 'sequence', 'period', and 'treatment'. 'Subjects within sequences' is included as random effect.|The Adjusted Geometric Mean is geometric mean adjusted by treatment. Ratio is calculated as: T1/R1. Intra-individual geometric coefficient of variation (gCV) = 14.2|Relative bioavailability||124.26|102.70|0.0413
72609260|NCT03886272|144747322|OTHER||Adjusted Geometric Mean Ratio (T2/R2)[%]|115.49||||0.0776|TWO_SIDED|90.0|105.23|126.74||P-value for ratio outside 80% - 125%|ANOVA|The model includes fixed effects for 'sequence', 'period', and 'treatment'. 'Subjects within sequences' is included as random effect.|The Adjusted Geometric Mean is geometric mean adjusted by treatment. Ratio is calculated as T2/R2. Intra-individual geometric coefficient of variation (gCV) = 13.9.|Relative bioavailability||126.74|105.23|0.0776
72325761|NCT02163577|144175048|SUPERIORITY||||||<|0.0001||||||Per GEE model, which included visit, regimen, visit by regimen as factors, and RSS total score at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 64||||< 0.0001
72325762|NCT02163577|144175048|SUPERIORITY||Difference in LS Means|-0.02|||||TWO_SIDED|95.0|-0.34|0.29||||||Difference in change to Week 64||0.29|-0.34|
72421650|NCT00532155|144354441|SUPERIORITY_OR_OTHER_LEGACY||Stratified Hazard ratio|0.819||||0.0035|TWO_SIDED|95.0|0.716|0.937|||Stratified Log-Rank test|Stratified on ECOG Performance Status (0 vs 1 vs 2) and Prior Bevacizumab (yes vs no) according to IVRS.|Stratified on ECOG Performance Status (0 vs 1 vs 2) and Prior Bevacizumab (yes vs no) according to IVRS.|||0.937|0.716|0.0035
72421651|NCT02134925|144354445|SUPERIORITY|||||||0.0004|||||||Wilcoxon (Mann-Whitney)|||||||0.0004
72421652|NCT02134925|144354450|SUPERIORITY|||||||0.0001|||||||Fisher Exact|||||||0.0001
72417900|NCT01970982|144346162|SUPERIORITY_OR_OTHER_LEGACY||Geometric LS Mean Ratio|47.1|||<|0.001|TWO_SIDED|95.0|44.3|50.08||The primary endpoints were tested using a multiple testing procedure to preserve the overall alpha level by simultaneously testing the endpoints using a closed procedure with each test performed at an alpha level of 2.5% one sided.|ANCOVA|ANCOVA model on COHb levels with product, sex, cigarette consumption, and baseline value as covariates.|LS mean ratio THS 2.2:CC|"The hypothesis to be tested is that the geometric mean level on Day 5 of the biomarker of exposure for THS 2.2 is lower relative to CC.~Analysis of the BoExp was conducted on the natural log scale in order to test the following hypothesis (one sided test with 2.5% type I error probability):~* Null hypothesis (H0): m1≥m2~* Alternative hypothesis (H1): m1\<m2 Where m1 and m2 are the geometric means of the BoExp levels on Day 5 for THS 2.2 and CC respectively."||50.08|44.30|<0.001
72421653|NCT02332590|144354473|SUPERIORITY||LS Mean Difference|-1.077|||<|0.0001|TWO_SIDED|95.0|-1.361|-0.793||Threshold for significance at 0.05 level.|Mixed Models Analysis||Sarilumab 200 mg vs. Adalimumab 40 mg|Analysis was performed using MMRM approach with treatment, region, visits, and treatment-by-visit interaction as fixed effects and baseline DAS28-ESR score as a continuous covariate. Hierarchical testing procedure was used to control overall alpha error rate at 0.05 level and handle multiple endpoint analyses. Testing was then performed sequentially in order endpoints are reported. Hierarchical testing sequence continued only when previous endpoint was statistically significant at 0.05 level.||-0.793|-1.361|<0.0001
72325763|NCT02163577|144175048|SUPERIORITY||||||<|0.0001||||||Per GEE model, which included visit, regimen, visit by regimen as factors, and RSS total score at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 160||||< 0.0001
72325764|NCT02163577|144175048|SUPERIORITY||||||<|0.0001||||||Per GEE model, which included visit, regimen, visit by regimen as factors, and RSS total score at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 160||||< 0.0001
72325765|NCT02163577|144175049|SUPERIORITY||||||<|0.0001||||||ANCOVA model includes RGI-C as the dependent variable, regimen group as factor, and RSS at baseline as covariate.|ANCOVA|||Week 40||||< 0.0001
72609261|NCT03886272|144747322|OTHER||Adj. Geometric Mean Ratio (T3c/R3) [%]|78.05||||0.6443|TWO_SIDED|90.0|69.71|87.38||P-value for ratio outside 80% - 125%|ANOVA|The model includes fixed effects for 'sequence', 'period', and 'treatment'. 'Subjects within sequences' is included as random effect.|The Adjusted Geometric Mean is geometric mean adjusted by treatment. Ratio is calculated as Tc3/R3. Intra-individual geometric coefficient of variation (gCV) = 17.6.|Relative bioavailability||87.38|69.71|0.6443
72325766|NCT02163577|144175049|SUPERIORITY||||||<|0.0001||||||ANCOVA model includes RGI-C as the dependent variable, regimen group as factor, and RSS at baseline as covariate.|ANCOVA|||Week 40||||< 0.0001
72325767|NCT02163577|144175049|SUPERIORITY||||||<|0.0001||||||GEE model includes RGI-C as the dependent variable, visit, regimen, visit by regimen as factors, and RSS total score at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 64||||< 0.0001
72609262|NCT03886272|144747322|OTHER||Adj. Geometric Mean Ratio (T3u/R3) [%]|45.97||||1|TWO_SIDED|90.0|41.05|51.48||P-value for ratio outside 80% - 125%|ANOVA|The model includes fixed effects for 'sequence', 'period', and 'treatment'. 'Subjects within sequences' is included as random effect.|The Adjusted Geometric Mean is geometric mean adjusted by treatment. Ratio is calculated as T3u/R3. Intra-individual geometric coefficient of variation (gCV) = 17.6.|Relative bioavailability||51.48|41.05|1.00
72609263|NCT03886272|144747323|OTHER||Adjusted Geometric Mean Ratio (T1/R1)[%]|144.62||||0.9485|TWO_SIDED|90.0|124.82|167.57||P-value for ratio outside 80% - 125%|ANOVA|The model includes fixed effects for 'sequence', 'period', and 'treatment'. 'Subjects within sequences' is included as random effect.|The Adjusted Geometric Mean is geometric mean adjusted by treatment. Ratio is calculated as T1/R1. Intra-individual geometric coefficient of variation (gCV) = 22.1|Relative bioavailability||167.57|124.82|0.9485
72609264|NCT03886272|144747323|OTHER||Adjusted Geometric Mean Ratio (T2/R2)[%]|129.69||||0.7813|TWO_SIDED|90.0|119.51|140.73||P-value for ratio outside 80% - 125%|ANOVA|The model includes fixed effects for 'sequence', 'period', and 'treatment'. 'Subjects within sequences' is included as random effect.|The adjusted geometric mean is geometric mean adjusted by treatment. Ratio is calculated as T2/R2. Intra-individual geometric coefficient of variation (gCV) = 12.2.|Relative Bioavailability||140.73|119.51|0.7813
72609265|NCT03886272|144747323|OTHER||Adj. Geometric Mean Ratio (T3c/R3) [%]|75.09||||0.7616|TWO_SIDED|90.0|64.58|87.32||P-value for ratio outside 80% - 125%|ANOVA|The model includes fixed effects for 'sequence', 'period', and 'treatment'. 'Subjects within sequences' is included as random effect.|The Adjusted Geometric Mean is geometric mean adjusted by treatment. Ratio is calculated as = T3c/3. Intra-individual geometric coefficient of variation (gCV) = 23.5.|Relative Bioavailability||87.32|64.58|0.7616
72325768|NCT02163577|144175049|SUPERIORITY||||||<|0.0001||||||GEE model includes RGI-C as the dependent variable, visit, regimen, visit by regimen as factors, and RSS total score at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 64||||< 0.0001
72609266|NCT03886272|144747323|OTHER||Adj. Geometric Mean Ratio (T3u/R3) [%]|41.45||||1|TWO_SIDED|90.0|35.61|48.25||P-value for ratio outside 80% - 125%|ANOVA|The model includes fixed effects for 'sequence', 'period', and 'treatment'. 'Subjects within sequences' is included as random effect.|The adjusted Geometric Mean is geometric mean adjusted by treatment. Ratio is calculated as = T3u/R3. Intra-individual geometric coefficient of variation = 23.5.|Relative Bioavailability||48.25|35.61|1.00
72609267|NCT03886272|144747324|OTHER||Adjusted Geometric Mean Ratio (T1/R1)[%]|111.11|STANDARD_DEVIATION|11.5||0.0092|TWO_SIDED|90.0|102.87|120.01||P-value for ratio outside 80% - 125%.|ANOVA|The model included fixed effects for 'sequence', 'period', and 'treatment'. 'Subjects within sequences' is included as random effect.|The Adjusted Geometric Mean is geometric mean adjusted by treatment. Ratio is calculated as T1/R1. Intra-individual geometric coefficient of variation (gCV) = 17.6.|Relative Bioavailability||120.01|102.87|0.0092
72609268|NCT03886272|144747324|OTHER||Adjusted Geometric Mean Ratio (T2/R2)[%]|114.13||||0.0442|TWO_SIDED|90.0|104.58|124.56||P-value for ratio outside 80% - 125%.|ANOVA|The model included fixed effects for 'sequence', 'period', and 'treatment'. 'Subjects within sequences' is included as random effect.|The Adjusted Geometric Mean is geometric mean adjusted by treatment. Ratio is calculated as = T2/R2. Intra-individual geometric coefficient of variation (gCV) = 13.0.|Relative Bioavailability||124.56|104.58|0.0442
72609269|NCT03886272|144747324|OTHER||Adj. Geometric Mean Ratio (T3c/R3) [%]|80.1||||0.4928|TWO_SIDED|90.0|71.54|89.68||P-value for ratio outside 80% - 125%|ANOVA|The model included fixed effects for 'sequence', 'period', and 'treatment'. 'Subjects within sequences' is included as random effect.|The Adjusted Geometric Mean is geometric mean adjusted by treatment. Ratio is calculated as = T3c/R3. Intra-individual geometric coefficient of variation (gCV) = 17.6.|Relative Bioavailability||89.68|71.54|0.4928
72325769|NCT02163577|144175049|SUPERIORITY||||||<|0.0001||||||GEE model includes RGI-C as the dependent variable, visit, regimen, visit by regimen as factors, and RSS total score at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 160||||< 0.0001
72609270|NCT03886272|144747324|OTHER||Adj. Geometric Mean Ratio (T3u/R3) [%]|48.83||||1|TWO_SIDED|90.0|43.6|54.69||P-value for ratio outside 80% - 125%.|ANOVA|The model included fixed effects for 'sequence', 'period', and 'treatment'. 'Subjects within sequences' is included as random effect.|The Adjusted Geometric Mean is geometric mean adjusted by treatment. Ratio is calculated as T3u/R3. Intra-individual geometric coefficient of variation (gCV) = 17.6.|Relative Bioavailability||54.69|43.60|1.00
72325770|NCT02163577|144175049|SUPERIORITY||||||<|0.0001||||||GEE model includes RGI-C as the dependent variable, visit, regimen, visit by regimen as factors, and RSS total score at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 160||||< 0.0001
72609271|NCT00931632|144747325|SUPERIORITY_OR_OTHER|||||||0.427|TWO_SIDED||||||Mantel Haenszel|||||||0.427
72325771|NCT02163577|144175050|SUPERIORITY||||||<|0.0001||||||ANCOVA model includes RGI-C as the dependent variable, regimen group as factor, and RSS at baseline as covariate.|ANCOVA|||Week 40||||< 0.0001
72325772|NCT02163577|144175050|SUPERIORITY||||||<|0.0001||||||ANCOVA model includes RGI-C as the dependent variable, regimen group as factor, and RSS at baseline as covariate.|ANCOVA|||Week 40||||< 0.0001
72609272|NCT01687218|144747336|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|1.03||||0.88|TWO_SIDED|95.0|0.73|1.44|||Generalized Estimating Equation (GEE)||It shows the rate ratio (RR) based on a GEE model comparing the Daily Rectal regimen with the Oral regimen and controlling for period in the model.|Since some participants have more than one safety event per period of treatment regimen, a Generalized Estimating Equation (GEE) model with a Poisson (log) link, exchangeable correlation structure, and robust standard errors were used.||1.44|0.73|0.88
72609273|NCT01687218|144747336|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.88||||0.43|TWO_SIDED|95.0|0.64|1.21|||Generalized Estimating Equation (GEE)||It shows the rate ratio (RR) based on a GEE model comparing the RAI Rectal regimen with the Oral regimen and controlling for period in the model.|Since some participants have more than one safety event per period of treatment regimen, a Generalized Estimating Equation (GEE) model with a Poisson (log) link, exchangeable correlation structure, and robust standard errors were used.||1.21|0.64|0.43
72609274|NCT01687218|144747337|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.28|||<|0.0001|TWO_SIDED|95.0|0.15|0.5|||Generalized Estimating Equation (GEE)||Oral regimen is the reference group.|Generalized Estimating Equation (GEE) models with a binomial (logit) link, an exchangeable correlation structure and robust errors and with treatment regimen and period as independent variables were used to compare the three treatment regimens for the acceptability endpoints. The oral arm and period 1 were used as the reference group in each of the models.||0.50|0.15|<0.0001
72609275|NCT01687218|144747337|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.37||||0.002|TWO_SIDED|95.0|0.2|0.7|||Generalized Estimating Equation (GEE)||Oral regimen is the reference group.|Generalized Estimating Equation (GEE) models with a binomial (logit) link, an exchangeable correlation structure and robust errors and with treatment regimen and period as independent variables were used to compare the three treatment regimens for the acceptability endpoints. The oral arm and period 1 were used as the reference group in each of the models.||0.70|0.20|0.002
72609276|NCT01687218|144747338|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.56||||0.08|TWO_SIDED|95.0|0.29|1.08|||Generalized Estimating Equation (GEE)||Oral regimen is the reference group.|Generalized Estimating Equation (GEE) models with a binomial (logit) link, an exchangeable correlation structure and robust errors and with treatment regimen and period as independent variables were used to compare the three treatment regimens for the acceptability endpoints. The oral arm and period 1 were used as the reference group in each of the models.||1.08|0.29|0.08
72609277|NCT01687218|144747338|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.76||||0.46|TWO_SIDED|95.0|0.37|1.56|||Generalized Estimating Equation (GEE)||Oral regimen is the reference group.|Generalized Estimating Equation (GEE) models with a binomial (logit) link, an exchangeable correlation structure and robust errors and with treatment regimen and period as independent variables were used to compare the three treatment regimens for the acceptability endpoints. The oral arm and period 1 were used as the reference group in each of the models.||1.56|0.37|0.46
72609278|NCT01687218|144747339|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.38||||0.0004|TWO_SIDED|95.0|0.22|0.65|||Generalized Estimating Equation (GEE)||Oral regimen is the reference group.|Generalized Estimating Equation (GEE) models with a binomial (logit) link, an exchangeable correlation structure and robust errors and with treatment regimen and period as independent variables were used to compare the three treatment regimens for the acceptability endpoints. The oral arm and period 1 were used as the reference group in each of the models.||0.65|0.22|0.0004
72609279|NCT01687218|144747339|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.7||||0.23|TWO_SIDED|95.0|0.39|1.25|||Generalized Estimating Equation (GEE)||Oral regimen is the reference group.|Generalized Estimating Equation (GEE) models with a binomial (logit) link, an exchangeable correlation structure and robust errors and with treatment regimen and period as independent variables were used to compare the three treatment regimens for the acceptability endpoints. The oral arm and period 1 were used as the reference group in each of the models.||1.25|0.39|0.23
72609280|NCT01687218|144747340|OTHER||Slope|-1.41|||<|0.001|TWO_SIDED|95.0|-1.53|-1.3|||Mixed Models Analysis||This comparison is between the daily rectal and oral (reference) groups for tenofovir levels in blood plasma, log10 ng/mL.|Mixed effects models were used to compare the three treatment regimens within participants over time using the oral regimen as the reference group. The models included fixed effects for treatment regimen and period and random effects for participant within sequence. The log 10 transformation was used in the mixed effects models for all PK results to achieve normality.||-1.30|-1.53|<0.001
72609281|NCT01687218|144747340|OTHER||Slope|-1.82|||<|0.001|TWO_SIDED|95.0|-1.95|-1.7|||Mixed Models Analysis||This comparison is between the RAI rectal and oral (reference) groups for tenofovir levels in blood plasma, log10 ng/mL.|Mixed effects models were used to compare the three treatment regimens within participants over time using the oral regimen as the reference group. The models included fixed effects for treatment regimen and period and random effects for participant within sequence. The log 10 transformation was used in the mixed effects models for all PK results to achieve normality.||-1.70|-1.95|<0.001
72609282|NCT01687218|144747341|SUPERIORITY||Slope|0.66|||<|0.001|TWO_SIDED|95.0|0.49|0.83|||Mixed Models Analysis||Oral regimen is the reference group.|Mixed effects models were used to compare the three treatment regimens within participants over time using the oral regimen as the reference group. The models included fixed effects for treatment regimen and period and random effects for participant within sequence. The log 10 transformation was used in the mixed effects models for all PK results to achieve normality.||0.83|0.49|<0.001
72609283|NCT01687218|144747341|SUPERIORITY||Slope|-0.16||||0.31|TWO_SIDED|95.0|-0.46|0.15|||Mixed Models Analysis||Oral regimen is the reference group.|Mixed effects models were used to compare the three treatment regimens within participants over time using the oral regimen as the reference group. The models included fixed effects for treatment regimen and period and random effects for participant within sequence. The log 10 transformation was used in the mixed effects models for all PK results to achieve normality.||0.15|-0.46|0.31
72421654|NCT02332590|144354474|SUPERIORITY||Odds Ratio (OR)|4.879|||<|0.0001|TWO_SIDED|95.0|2.536|9.389||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel||Sarilumab 200 mg vs. Adalimumab 40 mg|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using Cochran-Mantel-Haenszel method stratified by region.||9.389|2.536|<0.0001
72421655|NCT02332590|144354475|SUPERIORITY||Odds Ratio (OR)|1.976||||0.0017|TWO_SIDED|95.0|1.289|3.028||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel||Sarilumab 200 mg vs. Adalimumab 40 mg|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using Cochran-Mantel-Haenszel method stratified by region.||3.028|1.289|0.0017
72325773|NCT02163577|144175050|SUPERIORITY||||||<|0.0001||||||GEE model includes RGI-C as the dependent variable, visit, regimen, visit by regimen as factors, and RSS total score at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 64||||< 0.0001
72325774|NCT02163577|144175050|SUPERIORITY||||||<|0.0001||||||GEE model includes RGI-C as the dependent variable, visit, regimen, visit by regimen as factors, and RSS total score at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 64||||< 0.0001
72325775|NCT02163577|144175050|SUPERIORITY||||||<|0.0001||||||GEE model includes RGI-C as the dependent variable, visit, regimen, visit by regimen as factors, and RSS total score at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 160||||< 0.0001
72325776|NCT02163577|144175050|SUPERIORITY||||||<|0.0001||||||GEE model includes RGI-C as the dependent variable, visit, regimen, visit by regimen as factors, and RSS total score at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 160||||< 0.0001
72325777|NCT02163577|144175051|SUPERIORITY|||||||0.0088|||||||one sample t-test|||Week 0 to Week 40||||0.0088
72325778|NCT02163577|144175051|SUPERIORITY|||||||0.465|||||||one sample t-test|||Week 0 to Week 40||||0.4650
72609284|NCT01687218|144747342|SUPERIORITY||Slope|0.3||||0.004|TWO_SIDED|95.0|0.1|0.5|||Mixed Models Analysis|||Mixed effects models were used to compare the three treatment regimens within participants over time using the oral regimen as the reference group. The models included fixed effects for treatment regimen and period and random effects for participant within sequence. The log 10 transformation was used in the mixed effects models for all PK results to achieve normality. Mid period and end period visits only were used in this analysis.||0.50|0.10|0.004
72609285|NCT01687218|144747342|SUPERIORITY||Slope|-0.7|||<|0.001|TWO_SIDED|95.0|-0.92|-0.47|||Mixed Models Analysis|||Mixed effects models were used to compare the three treatment regimens within participants over time using the oral regimen as the reference group. The models included fixed effects for treatment regimen and period and random effects for participant within sequence. The log 10 transformation was used in the mixed effects models for all PK results to achieve normality.||-0.47|-0.92|<0.001
72609286|NCT01687218|144747343|SUPERIORITY||Slope|-2.66|||<|0.001|TWO_SIDED|95.0|-2.82|-2.5|||Mixed Models Analysis|||Mixed effects models were used to compare the three treatment regimens within participants over time using the oral regimen as the reference group. The models included fixed effects for treatment regimen and period and random effects for participant within sequence. The log 10 transformation was used in the mixed effects models for all PK results to achieve normality for the following analysis.||-2.50|-2.82|<0.001
72609287|NCT01687218|144747343|SUPERIORITY||Slope|-2.65|||<|0.001|TWO_SIDED|95.0|-2.81|-2.49|||Mixed Models Analysis|||Mixed effects models were used to compare the three treatment regimens within participants over time using the oral regimen as the reference group. The models included fixed effects for treatment regimen and period and random effects for participant within sequence. The log 10 transformation was used in the mixed effects models for all PK results to achieve normality for the following analysis.||-2.49|-2.81|<0.001
72609288|NCT01687218|144747344|SUPERIORITY||Slope|-0.91|||<|0.001|TWO_SIDED|95.0|-1.01|-0.8|||Mixed Models Analysis|||Mixed effects models were used to compare the three treatment regimens within participants over time using the oral regimen as the reference group. The models included fixed effects for treatment regimen and period and random effects for participant within sequence. The log 10 transformation was used in the mixed effects models for all PK results to achieve normality. End period visits only are used in this analysis.||-0.80|-1.01|<0.001
72609289|NCT01687218|144747344|SUPERIORITY||Slope|-0.91|||<|0.001|TWO_SIDED|95.0|-1.01|-0.8|||Mixed Models Analysis|||Mixed effects models were used to compare the three treatment regimens within participants over time using the oral regimen as the reference group. The models included fixed effects for treatment regimen and period and random effects for participant within sequence. The log 10 transformation was used in the mixed effects models for all PK results to achieve normality. End period visits only are used in this analysis.||-0.80|-1.01|<0.001
72609290|NCT01687218|144747345|SUPERIORITY||Slope|-2.0|||<|0.001|TWO_SIDED|95.0|-2.16|-1.84|||Mixed Models Analysis|||Mixed effects models were used to compare the three treatment regimens within participants over time using the oral regimen as the reference group. The models included fixed effects for treatment regimen and period and random effects for participant within sequence. The log 10 transformation was used in the mixed effects models for all PK results to achieve normality. Mid period and end period visits only are used in this analysis.||-1.84|-2.16|<0.001
72609291|NCT01687218|144747345|SUPERIORITY||Slope|-1.9|||<|0.001|TWO_SIDED|95.0|-2.07|-1.74|||Mixed Models Analysis|||Mixed effects models were used to compare the three treatment regimens within participants over time using the oral regimen as the reference group. The models included fixed effects for treatment regimen and period and random effects for participant within sequence. The log 10 transformation was used in the mixed effects models for all PK results to achieve normality. Mid period and end period visits only are used in this analysis.||-1.74|-2.07|<0.001
72609292|NCT01687218|144747346|SUPERIORITY||Slope|0.54|||<|0.001|TWO_SIDED|95.0|0.35|0.72|||Mixed Models Analysis|||Mixed effects models were used to compare the three treatment regimens within participants over time using the oral regimen as the reference group. The models included fixed effects for treatment regimen and period and random effects for participant within sequence. The log 10 transformation was used in the mixed effects models for all PK results to achieve normality.||0.72|0.35|<0.001
72609293|NCT01687218|144747346|SUPERIORITY||Slope|0.01||||0.92|TWO_SIDED|95.0|-0.28|0.31|||Mixed Models Analysis|||Mixed effects models were used to compare the three treatment regimens within participants over time using the oral regimen as the reference group. The models included fixed effects for treatment regimen and period and random effects for participant within sequence. The log 10 transformation was used in the mixed effects models for all PK results to achieve normality.||0.31|-0.28|0.92
72609294|NCT01687218|144747347|SUPERIORITY||Odds Ratio (OR)|0.35||||0.0005|TWO_SIDED|95.0|0.19|0.63|||Generalized Estimating Equations (GEE)||Oral regimen is the reference group.|Generalized Estimating Equation (GEE) models with a binomial (logit) link, an exchangeable correlation structure and robust errors and with treatment regimen and period as independent variables was used to compare the three treatment regimens for the acceptability endpoints. Because the distribution of the adherence percentages were skewed, we did not use a linear mixed effects model as originally planned. Instead, we dichotomized the adherence percentage into\<80% adherence versus\>80% adherence.||0.63|0.19|0.0005
72609295|NCT01687218|144747347|SUPERIORITY||Odds Ratio (OR)|0.89||||0.74|TWO_SIDED|95.0|0.43|1.81|||Generalized Estimating Equations (GEE)||Oral regimen is the reference group.|Generalized Estimating Equation (GEE) models with a binomial (logit) link, an exchangeable correlation structure and robust errors and with treatment regimen and period as independent variables was used to compare the three treatment regimens for the acceptability endpoints. Because the distribution of the adherence percentages were skewed, we did not use a linear mixed effects model as originally planned. Instead, we dichotomized the adherence percentage into\<80% adherence versus\>80% adherence.||1.81|0.43|0.74
72609296|NCT01257347|144747380|SUPERIORITY_OR_OTHER||||||<=|0.001||||||We included a stopping rule in which recruitment would be stopped at the midpoint for futility if the z-score was negative or for efficacy if the z-score was positive and the p-value ≤ 0.001.|GEE model|GEE models (logit link) with clinician as the cluster variable, appropriateness of management as outcome, intervention group as explanatory variable.||The sample size was calculated to have sufficient power to detect meaningful differences in appropriateness of clinician management between intervention and control groups. Each patient-clinician encounter was treated as independent and the sample size was inflated to account for the design effect (DE) of clustering of patients within clinician. GEE stands for generalized estimating equation.||||<=0.001
72609297|NCT03204643|144747384|SUPERIORITY||Odds Ratio (OR)|0.74||||0.06|TWO_SIDED|95.0|0.54|1.02|||Regression, Logistic|||||1.02|0.54|0.06
72609298|NCT03204643|144747385|SUPERIORITY||Odds Ratio (OR)|1.07||||0.76|TWO_SIDED|95.0|0.7|1.64|||Mixed Models Analysis|||||1.64|0.70|0.76
72609299|NCT03204643|144747386|SUPERIORITY||Odds Ratio (OR)|1.16||||0.62|TWO_SIDED|95.0|0.65|2.08|||Mixed Models Analysis|||||2.08|0.65|0.62
72609300|NCT03204643|144747387|SUPERIORITY||Odds Ratio (OR)|1.35||||0.08|TWO_SIDED|0.96|0.96|1.9|||Mixed Models Analysis|||||1.90|0.96|0.08
72609301|NCT01618968|144747417|NON_INFERIORITY_OR_EQUIVALENCE|Bioavailability comparisons were performed at each dose level.|Test / Reference Ratio|127.99|||||TWO_SIDED|90.0|121.61|134.7||||||To compare the relative bioavailability of methotrexate (MTX) following oral administration to that obtained after subcutaneous (SC) injection into the abdomen using the VIBEX MTX device by measuring the area under the curve from time zero to the last measurable concentration AUC(0-inf).||134.70|121.61|
72609302|NCT01618968|144747417|NON_INFERIORITY_OR_EQUIVALENCE|Bioavailability comparisons were performed at each dose level.|Test / Reference Ratio|125.48|||||TWO_SIDED|90.0|119.43|131.84||||||To compare the relative bioavailability of MTX following oral administration to that obtained after SC injection into the thigh using the VIBEX MTX device by measuring the AUC(0-Inf).||131.84|119.43|
72325779|NCT02163577|144175051|SUPERIORITY|||||||0.016|||||||one sample t test|||Week 0 to Week 64||||0.0160
72609303|NCT01618968|144747417|NON_INFERIORITY_OR_EQUIVALENCE|Test of bioequivalence was performed at each dose level.|Test / Reference ratio|101.85|||||TWO_SIDED|90.0|99.41|104.36||||||To compare the relative bioavailability of MTX following SC injection into the abdomen to that obtained after SC injection into the thigh using the VIBEX MTX device by measuring the AUC(0-inf)||104.36|99.41|
72609304|NCT01618968|144747418|NON_INFERIORITY_OR_EQUIVALENCE|Bioavailability comparisons were performed at each dose level.|Test / Reference Ratio|127.65|||||TWO_SIDED|90.0|121.28|134.36||||||To compare the relative bioavailability of methotrexate (MTX) following oral administration to that obtained after subcutaneous (SC) injection into the abdomen using the VIBEX MTX device by measuring the area under the curve from time zero to the 24 hour concentration AUC(0-24)||134.36|121.28|
72325780|NCT02163577|144175051|SUPERIORITY|||||||0.4114|||||||one sample t test|||Week 0 to Week 64||||0.4114
72325781|NCT02163577|144175051|SUPERIORITY|||||||0.5335|||||||one sample t test|||Week 64 to Week 112||||0.5335
72325782|NCT02163577|144175051|SUPERIORITY|||||||0.8606|||||||one sample t test|||Week 64 to Week 112||||0.8606
72325783|NCT02163577|144175051|SUPERIORITY|||||||0.1627|||||||one sample t test|||Week 112 to Week 160||||0.1627
72325784|NCT02163577|144175051|SUPERIORITY|||||||0.4096|||||||one sample t test|||Week 112 to Week 160||||0.4096
72325785|NCT02163577|144175052|SUPERIORITY||||||<|0.0001||||||GEE model included change from baseline for standing height Z score as dependent variable; visit, regimen, visit by regimen, and gender as factors; and age and standing height Z score at baseline as covariates, with exchangeable covariance structure.|GEE model|||Week 40||||< 0.0001
72325786|NCT02163577|144175052|SUPERIORITY|||||||0.0569||||||GEE model included change from baseline for standing height Z score as dependent variable; visit, regimen, visit by regimen, and gender as factors; and age and standing height Z score at baseline as covariates, with exchangeable covariance structure.|GEE model|||Week 40||||0.0569
72417901|NCT05711641|144346165|OTHER|VAS was described with the use of summary measures, and the variations between the applied substances were compared with the use of Generalized Estimating Equations (GEE) with normal marginal distribution and identity binding function, assuming an interchangeable correlation matrix between the substances (McCullagh; Nelder, 1989).|Generalized Estimating Equations|||||||||||||||"The alternative hypothesis of this study is that 10% lidocaine, applied topically to the external auditory canal (EAC), acts on tinnitus intensity differently than placebo, while the null hypothesis is that there is no difference between the action of lidocaine and placebo on tinnitus intensity.~The analyses were performed using the IBM-SPSS for Windows software version 22.0 and tabulated using the Microsoft-Excel 2010 software, and the tests were performed with a significance level of 5%."|VAS was described with the use of summary measures, and the variations between the applied substances were compared with the use of Generalized Estimating Equations (GEE) with normal marginal distribution and identity binding function, assuming an interchangeable correlation matrix between the substances (McCullagh; Nelder, 1989).|||
72417902|NCT05711641|144346166|OTHER|Tinnitus loudness was described with the use of summary measures, and the variations between the applied substances were compared with the use of Generalized Estimating Equations (GEE) with normal marginal distribution and identity binding function, assuming an interchangeable correlation matrix between the substances (McCullagh; Nelder, 1989).||||||||||||||||"The alternative hypothesis of this study is that 10% lidocaine, applied topically to the external auditory canal (EAC), acts on tinnitus intensity differently than placebo, while the null hypothesis is that there is no difference between the action of lidocaine and placebo on tinnitus intensity.~The analyses were performed using the IBM-SPSS for Windows software version 22.0 and tabulated using the Microsoft-Excel 2010 software, and the tests were performed with a significance level of 5%."|Tinnitus loudness was described with the use of summary measures, and the variations between the applied substances were compared with the use of Generalized Estimating Equations (GEE) with normal marginal distribution and identity binding function, assuming an interchangeable correlation matrix between the substances (McCullagh; Nelder, 1989).|||
72609305|NCT01618968|144747418|NON_INFERIORITY_OR_EQUIVALENCE|Bioavailability comparisons were performed at each dose level.|Test / Reference ratio|125.2|||||TWO_SIDED|90.0|119.16|131.55||||||To compare the relative bioavailability of methotrexate (MTX) following oral administration to that obtained after subcutaneous (SC) injection into the thigh using the VIBEX MTX device by measuring the area under the curve from time zero to the 24 hour concentration AUC(0-24)||131.55|119.16|
72609306|NCT01618968|144747418|NON_INFERIORITY_OR_EQUIVALENCE|Test of bioequivalence was performed at each dose level.|Test / Reference Ratio|101.82|||||TWO_SIDED|90.0|99.39|104.31||||||To compare the relative bioavailability of MTX following SC injection into the abdomen to that obtained after SC injection into the thigh using the VIBEX MTX device by measuring the area under the curve from time zero to the 24 hour concentration AUC(0-24)||104.31|99.39|
72609307|NCT01618968|144747419|NON_INFERIORITY_OR_EQUIVALENCE|Bioavailability comparisons were performed at each dose level.|Test / Reference ratio|94.83|||||TWO_SIDED|90.0|86.42|104.06||||||To compare the relative bioavailability of methotrexate (MTX) following oral administration to that obtained after subcutaneous (SC) injection into the abdomen using the VIBEX MTX device by measuring the maximum observed concentration (Cmax)||104.06|86.42|
72609308|NCT01618968|144747419|NON_INFERIORITY_OR_EQUIVALENCE|Bioavailability comparisons were performed at each dose level.|Test / Reference Ratio|82.12|||||TWO_SIDED|90.0|76.16|88.55||||||To compare the relative bioavailability of methotrexate (MTX) following oral administration to that obtained after subcutaneous (SC) injection into the thigh using the VIBEX MTX device by measuring the maximum observed concentration (Cmax)||88.55|76.16|
72609309|NCT01618968|144747419|NON_INFERIORITY_OR_EQUIVALENCE|Test of bioequivalence was performed at each dose level.|Test / Reference Ratio|115.63|||||TWO_SIDED|90.0|108.83|122.86||||||To compare the relative bioavailability of MTX following SC injection into the abdomen to that obtained after SC injection into the thigh using the VIBEX MTX device by measuring the maximum observed concentration (Cmax)||122.86|108.83|
72609310|NCT04356937|144747451|SUPERIORITY||Hazard Ratio (HR)|0.83||||0.64|TWO_SIDED|95.0|0.38|1.81|||Log Rank|||||1.81|0.38|0.64
72609311|NCT04356937|144747452|SUPERIORITY||Hazard Ratio (HR)|1.11||||0.73|TWO_SIDED|95.0|0.59|2.1|||Log Rank|||||2.10|0.59|0.73
72609312|NCT04356937|144747453|SUPERIORITY||Hazard Ratio (HR)|0.94||||0.69|TWO_SIDED|95.0|0.67|1.3|||Log Rank|||||1.30|0.67|0.69
72609313|NCT03533751|144747460|SUPERIORITY||Least Squares (LS) Mean Difference|7.75|STANDARD_ERROR_OF_MEAN|10.235||0.4498|TWO_SIDED|95.0|-12.4066|27.8983|||ANCOVA|The p-value was obtained using a mixed effect analysis of covariance (ANCOVA) model with treatment as fixed effect and Baseline EASI as covariate.|Difference = Etokimab - Placebo|||27.8983|-12.4066|0.4498
72609314|NCT03533751|144747460|SUPERIORITY||LS Mean Difference|-6.32|STANDARD_ERROR_OF_MEAN|9.39||0.501|TWO_SIDED|95.0|-24.774|12.1262|||ANCOVA|The p-value was obtained using a mixed effect ANCOVA model with treatment as fixed effect and Baseline EASI as covariate.|Difference = Etokimab - Placebo|||12.1262|-24.7740|0.5010
72609315|NCT03533751|144747460|SUPERIORITY||LS Mean Difference|1.97|STANDARD_ERROR_OF_MEAN|9.454||0.8349|TWO_SIDED|95.0|-16.6037|20.5476|||ANCOVA|The p-value was obtained using a mixed effect ANCOVA model with treatment as fixed effect and Baseline EASI as covariate.|Difference = Etokimab - Placebo|||20.5476|-16.6037|0.8349
72609316|NCT03533751|144747460|SUPERIORITY||LS Mean Difference|4.82|STANDARD_ERROR_OF_MEAN|11.154||0.6662|TWO_SIDED|95.0|-17.1892|26.8275|||ANCOVA|The p-value was obtained using a mixed effect ANCOVA model with treatment as fixed effect and Baseline EASI as covariate.|Difference = Etokimab - Placebo|||26.8275|-17.1892|0.6662
72609317|NCT03533751|144747461|SUPERIORITY||Odds Ratio (OR)|0.91||||0.7992|TWO_SIDED|95.0|0.42|1.9509|||Regression, Logistic|Logistic regression model with treatment as fixed effect and Baseline EASI as a covariate.||||1.9509|0.4200|0.7992
72609318|NCT03533751|144747461|SUPERIORITY||Odds Ratio (OR)|1.59||||0.2197|TWO_SIDED|95.0|0.757|3.3572|||Regression, Logistic|Logistic regression model with treatment as fixed effect and Baseline EASI as a covariate.||||3.3572|0.7570|0.2197
72609319|NCT03533751|144747461|SUPERIORITY||Odds Ratio (OR)|1.15||||0.7197|TWO_SIDED|95.0|0.5345|2.4774|||Regression, Logistic|Logistic regression model with treatment as fixed effect and Baseline EASI as a covariate.||||2.4774|0.5345|0.7197
72609320|NCT03533751|144747461|SUPERIORITY||Odds Ratio (OR)|0.85||||0.6772|TWO_SIDED|95.0|0.391|1.8404|||Regression, Logistic|Logistic regression model with treatment as fixed effect and Baseline EASI as a covariate.||||1.8404|0.3910|0.6772
72325787|NCT02163577|144175052|SUPERIORITY|||||||0.0002||||||GEE model included change from baseline for standing height Z score as dependent variable; visit, regimen, visit by regimen, and gender as factors; and age and standing height Z score at baseline as covariates, with exchangeable covariance structure.|GEE model|||Week 64||||0.0002
72325788|NCT02163577|144175052|SUPERIORITY|||||||0.0456||||||GEE model included change from baseline for standing height Z score as dependent variable; visit, regimen, visit by regimen, and gender as factors; and age and standing height Z score at baseline as covariates, with exchangeable covariance structure.|GEE model|||Week 64||||0.0456
72325789|NCT02163577|144175052|SUPERIORITY||||||<|0.0001||||||GEE model included change from baseline for standing height Z score as dependent variable; visit, regimen, visit by regimen, and gender as factors; and age and standing height Z score at baseline as covariates, with exchangeable covariance structure.|GEE model|||Week 160||||< 0.0001
72325790|NCT02163577|144175052|SUPERIORITY|||||||0.0343||||||GEE model included change from baseline for standing height Z score as dependent variable; visit, regimen, visit by regimen, and gender as factors; and age and standing height Z score at baseline as covariates, with exchangeable covariance structure.|GEE model|||Week 160||||0.0343
72421656|NCT02332590|144354476|SUPERIORITY||Odds Ratio (OR)|2.286||||0.0036|TWO_SIDED|95.0|1.3|4.02||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel||Sarilumab 200 mg vs. Adalimumab 40 mg|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using Cochran-Mantel-Haenszel method stratified by region.||4.020|1.300|0.0036
72325791|NCT02163577|144175057|SUPERIORITY|||||||0.0771||||||GEE model included change in 6MWT score as the dependent variable; visit, regimen, visit by regimen as factors; and 6MWT at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 40||||0.0771
72325792|NCT02163577|144175057|SUPERIORITY|||||||0.9098||||||GEE model included change in 6MWT score as the dependent variable; visit, regimen, visit by regimen as factors; and 6MWT at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 40||||0.9098
72325793|NCT02163577|144175057|SUPERIORITY|||||||0.0007||||||GEE model included change in percent of predicted 6MWT score as the dependent variable; visit, regimen, visit by regimen as factors; and 6MWT at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 64||||0.0007
72325794|NCT02163577|144175057|SUPERIORITY|||||||0.0327||||||GEE model included change in percent of predicted 6MWT score as the dependent variable; visit, regimen, visit by regimen as factors; and 6MWT at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 64||||0.0327
72325795|NCT02163577|144175057|SUPERIORITY|||||||0.1865||||||GEE model included change in percent of predicted 6MWT score as the dependent variable; visit, regimen, visit by regimen as factors; and 6MWT at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 160||||0.1865
72325796|NCT02163577|144175057|SUPERIORITY|||||||0.2654||||||GEE model included change in percent of predicted 6MWT score as the dependent variable; visit, regimen, visit by regimen as factors; and 6MWT at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 160||||0.2654
72325797|NCT02163577|144175058|SUPERIORITY||||||<|0.0001||||||GEE model includes change in POSNA-PODCI score as the dependent variable, visit, regimen, visit by regimen as factors, and POSNA-PODCI at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 40||||< 0.0001
72325798|NCT02163577|144175058|SUPERIORITY|||||||0.0144||||||GEE model includes change in POSNA-PODCI score as the dependent variable, visit, regimen, visit by regimen as factors, and POSNA-PODCI at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 40||||0.0144
72609321|NCT03533751|144747462|SUPERIORITY||Odds Ratio (OR)|1.03||||0.9537|TWO_SIDED|95.0|0.3922|2.6994|||Regression, Logistic|Logistic regression model with treatment as fixed effect and Baseline EASI as a covariate.||||2.6994|0.3922|0.9537
72609322|NCT03533751|144747462|SUPERIORITY||Odds Ratio (OR)|1.57||||0.3316|TWO_SIDED|95.0|0.6323|3.8895|||Regression, Logistic|Logistic regression model with treatment as fixed effect and Baseline EASI as a covariate.||||3.8895|0.6323|0.3316
72609323|NCT03533751|144747462|SUPERIORITY||Odds Ratio (OR)|1.36||||0.5166|TWO_SIDED|95.0|0.5331|3.4944|||Regression, Logistic|Logistic regression model with treatment as fixed effect and Baseline EASI as a covariate.||||3.4944|0.5331|0.5166
72609324|NCT03533751|144747462|SUPERIORITY||Odds Ratio (OR)|1.17||||0.7426|TWO_SIDED|95.0|0.4545|3.0223|||Regression, Logistic|Logistic regression model with treatment as fixed effect and Baseline EASI as a covariate.||||3.0223|0.4545|0.7426
72609325|NCT03533751|144747463|SUPERIORITY||Odds Ratio (OR)|1.76||||0.4543|TWO_SIDED|95.0|0.3998|7.7615|||Regression, Logistic|Logistic regression model with treatment as fixed effect and Baseline EASI as a covariate.||||7.7615|0.3998|0.4543
72609326|NCT03533751|144747463|SUPERIORITY||Odds Ratio (OR)|2.57||||0.1874|TWO_SIDED|95.0|0.6314|10.4827|||Regression, Logistic|Logistic regression model with treatment as fixed effect and Baseline EASI as a covariate.||||10.4827|0.6314|0.1874
72609327|NCT03533751|144747463|SUPERIORITY||Odds Ratio (OR)|2.69||||0.1721|TWO_SIDED|95.0|0.6506|11.0814|||Regression, Logistic|Logistic regression model with treatment as fixed effect and Baseline EASI as a covariate.||||11.0814|0.6506|0.1721
72609328|NCT03533751|144747463|SUPERIORITY||Odds Ratio (OR)|0.68||||0.6755|TWO_SIDED|95.0|0.1086|4.2141|||Regression, Logistic|Logistic regression model with treatment as fixed effect and Baseline EASI as a covariate.||||4.2141|0.1086|0.6755
72609329|NCT03533751|144747464|SUPERIORITY||Odds Ratio (OR)|0.75||||0.6058|TWO_SIDED|95.0|0.2481|2.2543|||Regression, Logistic|Logistic regression model with treatment as fixed effect and baseline vIGA-AD score as covariate.||||2.2543|0.2481|0.6058
72609330|NCT03533751|144747464|SUPERIORITY||Odds Ratio (OR)|0.97||||0.9521|TWO_SIDED|95.0|0.3356|2.7923|||Regression, Logistic|Logistic regression model with treatment as fixed effect and Baseline vIGA-AD score as a covariate.||||2.7923|0.3356|0.9521
72609331|NCT03533751|144747464|SUPERIORITY||Odds Ratio (OR)|1.23||||0.6905|TWO_SIDED|95.0|0.4457|3.3878|||Regression, Logistic|Logistic regression model with treatment as fixed effect and Baseline vIGA-AD score as a covariate.||||3.3878|0.4457|0.6905
72609332|NCT03533751|144747464|SUPERIORITY||Odds Ratio (OR)|1.04||||0.9399|TWO_SIDED|95.0|0.3671|2.9518|||Regression, Logistic|Logistic regression model with treatment as fixed effect and Baseline vIGA-AD score as a covariate.||||2.9518|0.3671|0.9399
72609333|NCT03533751|144747465|SUPERIORITY||Odds Ratio (OR)|1.22||||0.7659|TWO_SIDED|95.0|0.329|4.5268|||Regression, Logistic|Logistic regression model with treatment as fixed effect and Baseline vIGA-AD score as covariate.||||4.5268|0.3290|0.7659
72609334|NCT03533751|144747465|SUPERIORITY||Odds Ratio (OR)|1.36||||0.6273|TWO_SIDED|95.0|0.3895|4.776|||Regression, Logistic|Logistic regression model with treatment as fixed effect and baseline vIGA-AD score as covariate.||||4.7760|0.3895|0.6273
72609335|NCT03533751|144747465|SUPERIORITY||Odds Ratio (OR)|1.88||||0.2967|TWO_SIDED|95.0|0.5734|6.1879|||Regression, Logistic|Logistic regression model with treatment as fixed effect and baseline vIGA-AD score as covariate.||||6.1879|0.5734|0.2967
72609336|NCT03533751|144747465|SUPERIORITY||Odds Ratio (OR)|1.46||||0.5544|TWO_SIDED|95.0|0.4152|5.1476|||Regression, Logistic|Logistic regression model with treatment as fixed effect and baseline vIGA-AD score as covariate.||||5.1476|0.4152|0.5544
72609337|NCT03533751|144747466|SUPERIORITY||Odds Ratio (OR)|1.12||||0.86|TWO_SIDED|95.0|0.3175|3.9513|||Regression, Logistic|Logistic regression model with treatment as fixed effect and Baseline peak weekly averaged NRS as covariate.||||3.9513|0.3175|0.8600
72609338|NCT03533751|144747466|SUPERIORITY||Odds Ratio (OR)|1.84||||0.3222|TWO_SIDED|95.0|0.5511|6.1214|||Regression, Logistic|Logistic regression model with treatment as fixed effect and Baseline peak weekly averaged NRS as covariate.||||6.1214|0.5511|0.3222
72609339|NCT03533751|144747466|SUPERIORITY||Odds Ratio (OR)|1.98||||0.2564|TWO_SIDED|95.0|0.6089|6.431|||Regression, Logistic|Logistic regression model with treatment as fixed effect and Baseline peak weekly averaged NRS as covariate.||||6.4310|0.6089|0.2564
72609340|NCT03533751|144747466|SUPERIORITY||Odds Ratio (OR)|1.89||||0.2912|TWO_SIDED|95.0|0.5806|6.1275|||Regression, Logistic|Logistic regression model with treatment as fixed effect and Baseline peak weekly averaged NRS as covariate.||||6.1275|0.5806|0.2912
72609341|NCT03533751|144747467|SUPERIORITY||LS Mean Difference|-1.17|STANDARD_ERROR_OF_MEAN|8.679||0.8927|TWO_SIDED|95.0|-18.2117|15.8686|||ANCOVA|Mixed effect ANCOVA model with treatment as fixed effect and Baseline weekly averaged peak NRS as covariate.|Difference = Etokimab - Placebo|||15.8686|-18.2117|0.8927
72609342|NCT03533751|144747467|SUPERIORITY||LS Mean Difference|3.43|STANDARD_ERROR_OF_MEAN|9.019||0.7035|TWO_SIDED|95.0|-14.2767|21.1463|||ANCOVA|Mixed effect ANCOVA model with treatment as fixed effect and Baseline weekly averaged peak NRS as covariate.|Difference = Etokimab - Placebo|||21.1463|-14.2767|0.7035
72421657|NCT02332590|144354477|SUPERIORITY||Odds Ratio (OR)|1.8||||0.0074|TWO_SIDED|95.0|1.168|2.773||Threshold for significance 0.05 level.|Cochran-Mantel-Haenszel||Sarilumab 200 mg vs. Adalimumab 40 mg|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using Cochran-Mantel-Haenszel method stratified by region.||2.773|1.168|0.0074
72421658|NCT02332590|144354478|SUPERIORITY||LS Mean Difference|-0.182||||0.0037|TWO_SIDED|95.0|-0.305|-0.059||Threshold for significance at 0.05 level.|Mixed Models Analysis||Sarilumab 200 mg vs. Adalimumab 40 mg|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using MMRM approach with treatment, region, visits, and treatment-by-visit interaction as fixed effects and baseline HAQ-DI score as a continuous covariate.||-0.059|-0.305|0.0037
72325799|NCT02163577|144175058|SUPERIORITY|||||||0.0384||||||GEE model includes change in POSNA-PODCI score as the dependent variable, visit, regimen, visit by regimen as factors, and POSNA-PODCI at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 64||||0.0384
72325800|NCT02163577|144175058|SUPERIORITY|||||||0.0004||||||GEE model includes change in POSNA-PODCI score as the dependent variable, visit, regimen, visit by regimen as factors, and POSNA-PODCI at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 64||||0.0004
72421659|NCT02332590|144354479|SUPERIORITY||LS Mean Difference|2.65||||0.0006|TWO_SIDED|95.0|1.147|4.153||Threshold for significance at 0.05 level.|Mixed Models Analysis||Sarilumab 200 mg vs. Adalimumab 40 mg|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using MMRM approach with treatment, region, visits, and treatment-by-visit interaction as fixed effects and baseline SF-36 PCS score as a continuous covariate.||4.153|1.147|0.0006
72609343|NCT03533751|144747467|SUPERIORITY||LS Mean Difference|-9.27|STANDARD_ERROR_OF_MEAN|8.608||0.2819|TWO_SIDED|95.0|-26.159|7.6237|||ANCOVA|Mixed effect ANCOVA model with treatment as fixed effect and Baseline weekly averaged peak NRS as covariate.|Difference = Etokimab - Placebo|||7.6237|-26.1590|0.2819
72609344|NCT03533751|144747467|SUPERIORITY||LS Mean Difference|-6.06|STANDARD_ERROR_OF_MEAN|8.557||0.4793|TWO_SIDED|95.0|-22.8452|10.7333|||ANCOVA|Mixed effect ANCOVA model with treatment as fixed effect and Baseline weekly averaged peak NRS as covariate.|Difference = Etokimab - Placebo|||10.7333|-22.8452|0.4793
72609345|NCT03533751|144747468|SUPERIORITY||LS Mean Difference|6.57|STANDARD_ERROR_OF_MEAN|6.677||0.3262|TWO_SIDED|95.0|-6.5723|19.7054|||ANCOVA|Mixed effect ANCOVA model with treatment as fixed effect and Baseline SCORAD as covariate.|Difference = Etokimab - Placebo|||19.7054|-6.5723|0.3262
72609346|NCT03533751|144747468|SUPERIORITY||LS Mean Difference|-1.23|STANDARD_ERROR_OF_MEAN|6.366||0.8465|TWO_SIDED|95.0|-13.7439|11.2782|||ANCOVA|Mixed effect ANCOVA model with treatment as fixed effect and Baseline SCORAD as covariate.|Difference = Etokimab - Placebo|||11.2782|-13.7439|0.8465
72609347|NCT03533751|144747468|SUPERIORITY||LS Mean Difference|2.51|STANDARD_ERROR_OF_MEAN|6.396||0.6947|TWO_SIDED|95.0|-10.0587|15.082|||ANCOVA|Mixed effect ANCOVA model with treatment as fixed effect and Baseline SCORAD as covariate.||||15.0820|-10.0587|0.6947
72609348|NCT03533751|144747468|SUPERIORITY||LS Mean Difference|6.76|STANDARD_ERROR_OF_MEAN|6.909||0.3288|TWO_SIDED|95.0|-6.8451|20.3626|||ANCOVA|Mixed effect ANCOVA model with treatment as fixed effect and Baseline SCORAD as covariate.|Difference = Etokimab - Placebo|||20.3626|-6.8451|0.3288
72609349|NCT03533751|144747469|SUPERIORITY||LS Mean Difference|0.26|STANDARD_ERROR_OF_MEAN|1.355||0.8497|TWO_SIDED|95.0|-2.4081|2.9218|||ANCOVA|Mixed effect ANCOVA model with treatment as fixed effect and Baseline DLQI score as covariate.|Difference = Etokimab - Placebo|||2.9218|-2.4081|0.8497
72609350|NCT03533751|144747469|SUPERIORITY||LS Mean Difference|-0.91|STANDARD_ERROR_OF_MEAN|1.35||0.5016|TWO_SIDED|95.0|-3.5636|1.7473|||ANCOVA|Mixed effect ANCOVA model with treatment as fixed effect and Baseline DLQI score as covariate.|Difference = Etokimab - Placebo|||1.7473|-3.5636|0.5016
72609351|NCT03533751|144747469|SUPERIORITY||LS Mean Difference|-0.44|STANDARD_ERROR_OF_MEAN|1.386||0.7511|TWO_SIDED|95.0|-3.167|2.287|||ANCOVA|Mixed effect ANCOVA model with treatment as fixed effect and Baseline DLQI score as covariate.|Difference = Etokimab - Placebo|||2.2870|-3.1670|0.7511
72609352|NCT03533751|144747469|SUPERIORITY||LS Mean Difference|0.43|STANDARD_ERROR_OF_MEAN|1.396||0.7558|TWO_SIDED|95.0|-2.3133|3.1824|||ANCOVA|Mixed effect ANCOVA model with treatment as fixed effect and Baseline DLQI score as covariate.|Difference = Etokimab - Placebo|||3.1824|-2.3133|0.7558
72609353|NCT03141359|144747473|SUPERIORITY||Rate|0.627||||0.388|TWO_SIDED|95.0|0.492|0.75|||Fisher Exact||Confidence interval estimated using the Clopper Pearson method.|We used a single-stage design to test null hypothesis (H0) that 1-yr PFS is \<= 0.60. Assuming one-sided α= 0.10, 60 patients provided 98% power to reject H0, assuming the true 1-yr PFS is 0.80. Since not all enrolled subjects received durva, study power was affected. For patients who did not receive durva, H0 was assumed to be 0.40 versus an alternative of 0.60. Including these subjects reduced power from 98%. The conditional power given that 13 evaluable subjects didn't receive durva was 88%.||0.750|0.492|.388
72609354|NCT03141359|144747476|OTHER|Estimation only|Rate|0.571|||||TWO_SIDED|95.0|0.422|0.712|||||Confidence interval estimated using the Clopper Pearson method.|||0.712|0.422|
72609355|NCT03141359|144747477|OTHER|Estimation only|Rate|0.75|||||TWO_SIDED|95.0|0.621|0.853|||||Confidence interval estimated using the Clopper Pearson method.|||0.853|0.621|
72609356|NCT03141359|144747485|OTHER|Estimation only|Rate|0.164|||||TWO_SIDED|95.0|0.082|0.281|||||Confidence interval estimated using the Clopper Pearson method.|||0.281|0.082|
72609357|NCT03141359|144747486|OTHER|Estimation only|Rate|0.246|||||TWO_SIDED|95.0|0.145|0.373|||||Confidence interval estimated using the Clopper Pearson method.|||0.373|0.145|
72609358|NCT01081626|144747492|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0135||||0.956|TWO_SIDED|95.0|-0.1325|0.1637|||Chi-squared, Corrected|||||0.1637|-0.1325|0.9560
72609359|NCT01081626|144747493|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.088||||0.7924|TWO_SIDED|95.0|0.7642|1.549|||Chi-squared|||||1.5490|0.7642|0.7924
72609360|NCT01081626|144747497|SUPERIORITY_OR_OTHER|||||||0.5331||95.0|||||Chi-squared|||||||0.5331
72609361|NCT01081626|144747498|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.015||||0.9351|TWO_SIDED|95.0|0.7175|1.435|||Chi-squared|||||1.4350|0.7175|0.9351
72609362|NCT00368251|144747513|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehmann-estimator of difference|0.15|||=|0.942|TWO_SIDED|95.0|-26.12|24.96||All hypotheses are tested at the 5 % level. The multiplicity scheme (hierarchical testing procedure) assures strong control of the type I error at the 5 % level.|stratified Wilcoxon Test|Estimates and confidence intervals from Hodges-Lehmann (unstratified).|Difference versus Placebo was calculated.|"The first hypothesis for the primary efficacy variable compares placebo versus Brivaracetam (BRV) 150 mg/day.~The second hypothesis for the primary efficacy variable compares placebo versus BRV 5 mg/day. However, this second hypothesis will only be tested when all the hypotheses for placebo versus BRV 150 mg/day are significant for the primary three UMRS related secondary endpoints.~The hypotheses will be tested using nonparametric analysis. The study was designed to have 80 % power."||24.96|-26.12|=0.942
72609363|NCT00368251|144747513|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehmann-estimator of difference|-18.05|||=|0.105|TWO_SIDED|95.0|-39.31|4.86||Tested at the 5 % level - given the primary endpoint and the three UMRS related secondary endpoints comparing placebo versus Brivaracetam (BRV) 150 mg/day are significant at the 5 % level (hierarchical testing procedure).|stratified Wilcoxon Test|Estimates and confidence intervals from Hodges-Lehmann (unstratified).|Difference versus Placebo.|||4.86|-39.31|=0.105
72417903|NCT05711641|144346167|OTHER|MML was described with the use of summary measures, and the variations between the applied substances were compared with the use of Generalized Estimating Equations (GEE) with normal marginal distribution and identity binding function, assuming an interchangeable correlation matrix between the substances (McCullagh; Nelder, 1989).||||||||||||||||"The alternative hypothesis of this study is that 10% lidocaine, applied topically to the external auditory canal (EAC), acts on tinnitus intensity differently than placebo, while the null hypothesis is that there is no difference between the action of lidocaine and placebo on tinnitus intensity.~The analyses were performed using the IBM-SPSS for Windows software version 22.0 and tabulated using the Microsoft-Excel 2010 software, and the tests were performed with a significance level of 5%."|MML was described with the use of summary measures, and the variations between the applied substances were compared with the use of Generalized Estimating Equations (GEE) with normal marginal distribution and identity binding function, assuming an interchangeable correlation matrix between the substances (McCullagh; Nelder, 1989).|||
72417904|NCT00951483|144346168|SUPERIORITY_OR_OTHER||Standardized test statistic (z-score)|-2.65||||0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||The null hypothesis is that C-reactive protein (CRP) is no different between the experimental and healthy control cohorts at 12 weeks.||||.001
72325801|NCT02163577|144175058|SUPERIORITY|||||||0.9795||||||GEE model includes change in POSNA-PODCI score as the dependent variable, visit, regimen, visit by regimen as factors, and POSNA-PODCI at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 160||||0.9795
72325802|NCT02163577|144175058|SUPERIORITY|||||||0.2082||||||GEE model includes change in POSNA-PODCI score as the dependent variable, visit, regimen, visit by regimen as factors, and POSNA-PODCI at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 160||||0.2082
72325803|NCT02163577|144175059|SUPERIORITY||||||<|0.0001||||||GEE model includes change in POSNA-PODCI score as the dependent variable, visit, regimen, visit by regimen as factors, and POSNA-PODCI at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 40||||< 0.0001
72609364|NCT00368251|144747514|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehmann-estimator of difference|1.24|||=|0.672|TWO_SIDED|95.0|-21.9|31.06||Tested at the 5 % level - given the Primary Outcome testing Placebo versus BRV 150 mg/day is significant at the 5 % level (hierarchical testing procedure).|stratified Wilcoxon Test|Estimates and confidence intervals are obtained from Hodges-Lehmann(unstratified).|Difference versus Placebo.|If primary efficacy is proven for Brivaracetam (BRV) 150 mg/day, the following secondary endpoints will be tested for Placebo versus BRV 150 mg/day. The testing scheme will be hierarchical, thus statistical significance at 5 % on BRV 150 mg/day on a secondary endpoint is needed to continue testing BRV 150 mg/day at 5 % significance level for the next secondary endpoint.||31.06|-21.90|=0.672
72325804|NCT02163577|144175059|SUPERIORITY|||||||0.0251||||||GEE model includes change in POSNA-PODCI score as the dependent variable, visit, regimen, visit by regimen as factors, and POSNA-PODCI at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 40||||0.0251
72325805|NCT02163577|144175059|SUPERIORITY|||||||0.9124||||||GEE model includes change in POSNA-PODCI score as the dependent variable, visit, regimen, visit by regimen as factors, and POSNA-PODCI at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 64||||0.9124
72609365|NCT00368251|144747514|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehmann-estimator of difference|0.0|||=|0.806|TWO_SIDED|95.0|-33.33|18.75||Tested at the 5 % level - given the primary endpoint testing Placebo versus Brivaracetam (BRV) 5 mg/day is significant at the 5 % level (hierarchical testing procedure).|stratified Wilcoxon Test|Estimates and confidence intevals are obtained from Hodges-Lehmann (unstratified).|Difference versus Placebo.|"In case the three endpoints are significant for placebo versus Brivaracetam (BRV) 150 mg/day, the primary endpoint will be tested for Placebo versus BRV 5 mg/day. In case of significance, the three UMRS related secondary endpoints will be tested for Placebo versus BRV 5 mg/day, provided the previous is significant at 5 %. Secondary endpoints are tested in the following order:~* Functional Disability~* Stimulus Sensitivity~* Myoclonus Patient Questionnaire"||18.75|-33.33|=0.806
72609366|NCT00368251|144747515|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehmann-estimator of difference|0.0|||=|0.549|TWO_SIDED|95.0|-25.0|100.0||Tested at the 5 % level - given the Functional Disability Score comparing Placebo versus Brivaracetam (BRV) 150 mg/day is significant at the 5 % level (hierarchical testing procedure).|stratified Willcoxon Test|Estimates and confidence intervals are obtained from Hodges-Lehmann (unstratified).|Difference versus Placebo.|||100.00|-25.00|=0.549
72609367|NCT00368251|144747515|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehmann-estimator of difference|0.0|||=|0.654|TWO_SIDED|95.0|-50.0|66.67||Tested at the 5 % level - given the Functional Disability Score comparing Placebo versus Brivaracetam (BRV) 5 mg/day is significant at the 5 % level (hierarchical testing procedure).|stratified Wilcoxon Test|Estimates and confidence intervals are obtained from Hodges-Lehmann (unstratified).|Difference versus Placebo.|||66.67|-50.00|=0.654
72609368|NCT00368251|144747516|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehmann-estimator of difference|14.29|||=|0.037|TWO_SIDED|95.0|-1.76|39.39||Tested at the 5 % level - given the Functional Disability Score comparing Placebo versus Brivaracetam (BRV) 150 mg/day is significant at the 5 % level (hierarchical testing procedure).|stratified Wilcoxon Test|Estimates and confidence intervals are obtained from Hodges-Lehmann (unstratified).|Difference versus Placebo.|||39.39|-1.76|=0.037
72609369|NCT00368251|144747516|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehmann-estimator of difference|10.0|||=|0.111|TWO_SIDED|95.0|-5.56|30.0||Tested at the 5 % level - given the Functional Disability Score comparing Placebo versus Brivaracetam (BRV) 5 mg/day is significant at the 5 % level (hierarchical testing procedure).|stratified Wilcoxon Test|Estimates and confidence intervals are obtained from Hodges-Lehmann (unstratified).|Difference versus Placebo.|||30.00|-5.56|=0.111
72609370|NCT00368251|144747517|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.931||||||The Global Evaluation Scale by Investigator (I-GES) was compared between placebo and each dose at 5 % significance level independently from the previous secondary endpoints.|Stratified Wilcoxon test|||||||=0.931
72609371|NCT00368251|144747517|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.253||||||The Global Evaluation Scale by Investigator (I-GES) was compared between placebo and each dose at 5 % significance level independently from the previous secondary endpoints.|Stratified Wilcoxon test|||P-value for pairwise comparison of each Brivaracetam dose versus Placebo.||||=0.253
72609372|NCT03312738|144747522|OTHER||Hazard Ratio (HR)|0.53|||||TWO_SIDED|90.0|0.4|0.71||||||||0.71|0.40|
72609373|NCT03312738|144747523|OTHER||Hazard Ratio (HR)|0.46|||||TWO_SIDED|90.0|0.32|0.67||||||||0.67|0.32|
72609374|NCT03312738|144747524|OTHER||Hazard Ratio (HR)|1.14|||||TWO_SIDED|90.0|0.69|1.89||||||||1.89|0.69|
72609375|NCT00607893|144747564|OTHER||Mean Difference (Final Values)|0.071||||0.38|TWO_SIDED|95.0|-0.09|0.23|||Regression, Linear||F2-isoprostanes/Cr was log-transformed before analysis. The estimation parameter shows the log-transformed mean difference of the absolute change between groups, while the least square means of two groups are transformed back for presentation.|||0.23|-0.090|0.38
72609376|NCT00607893|144747565|OTHER||Mean Difference (Final Values)|1.83||||0.85|TWO_SIDED|95.0|-17.42|21.07|||Regression, Linear|||||21.07|-17.42|0.85
72325806|NCT02163577|144175059|SUPERIORITY|||||||0.0016||||||GEE model includes change in POSNA-PODCI score as the dependent variable, visit, regimen, visit by regimen as factors, and POSNA-PODCI at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 64||||0.0016
72325807|NCT02163577|144175059|SUPERIORITY|||||||0.5677||||||GEE model includes change in POSNA-PODCI score as the dependent variable, visit, regimen, visit by regimen as factors, and POSNA-PODCI at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 160||||0.5677
72325808|NCT02163577|144175059|SUPERIORITY||||||<|0.0001||||||GEE model includes change in POSNA-PODCI score as the dependent variable, visit, regimen, visit by regimen as factors, and POSNA-PODCI at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 160||||< 0.0001
72325809|NCT02163577|144175060|SUPERIORITY||||||<|0.0001||||||GEE model includes change in POSNA-PODCI score as the dependent variable, visit, regimen, visit by regimen as factors, and POSNA-PODCI at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 40||||< 0.0001
72325810|NCT02163577|144175060|SUPERIORITY||||||<|0.0001||||||GEE model includes change in POSNA-PODCI score as the dependent variable, visit, regimen, visit by regimen as factors, and POSNA-PODCI at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 40||||< 0.0001
72325811|NCT02163577|144175060|SUPERIORITY|||||||0.0033||||||GEE model includes change in POSNA-PODCI score as the dependent variable, visit, regimen, visit by regimen as factors, and POSNA-PODCI at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 64||||0.0033
72325812|NCT02163577|144175060|SUPERIORITY|||||||0.0001||||||GEE model includes change in POSNA-PODCI score as the dependent variable, visit, regimen, visit by regimen as factors, and POSNA-PODCI at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 64||||0.0001
72325813|NCT02163577|144175060|SUPERIORITY||||||<|0.0001||||||GEE model includes change in POSNA-PODCI score as the dependent variable, visit, regimen, visit by regimen as factors, and POSNA-PODCI at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 160||||< 0.0001
72325814|NCT02163577|144175060|SUPERIORITY||||||<|0.0001||||||GEE model includes change in POSNA-PODCI score as the dependent variable, visit, regimen, visit by regimen as factors, and POSNA-PODCI at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 160||||< 0.0001
72325815|NCT02163577|144175061|SUPERIORITY|||||||0.0014||||||GEE model includes change in POSNA-PODCI score as the dependent variable, visit, regimen, visit by regimen as factors, and POSNA-PODCI at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 40||||0.0014
72325816|NCT02163577|144175061|SUPERIORITY|||||||0.0028||||||GEE model includes change in POSNA-PODCI score as the dependent variable, visit, regimen, visit by regimen as factors, and POSNA-PODCI at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 40||||0.0028
72325817|NCT02163577|144175061|SUPERIORITY|||||||0.0536||||||GEE model includes change in POSNA-PODCI score as the dependent variable, visit, regimen, visit by regimen as factors, and POSNA-PODCI at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 64||||0.0536
72325818|NCT02163577|144175061|SUPERIORITY|||||||0.0002||||||GEE model includes change in POSNA-PODCI score as the dependent variable, visit, regimen, visit by regimen as factors, and POSNA-PODCI at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 64||||0.0002
72325819|NCT02163577|144175061|SUPERIORITY||||||<|0.0001||||||GEE model includes change in POSNA-PODCI score as the dependent variable, visit, regimen, visit by regimen as factors, and POSNA-PODCI at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 160||||< 0.0001
72325820|NCT02163577|144175061|SUPERIORITY||||||<|0.0001||||||GEE model includes change in POSNA-PODCI score as the dependent variable, visit, regimen, visit by regimen as factors, and POSNA-PODCI at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 160||||< 0.0001
72325821|NCT02163577|144175062|SUPERIORITY|||||||0.223||||||GEE model includes change in POSNA-PODCI score as the dependent variable, visit, regimen, visit by regimen as factors, and POSNA-PODCI at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 40||||0.2230
72325822|NCT02163577|144175062|SUPERIORITY|||||||0.1132||||||GEE model includes change in POSNA-PODCI score as the dependent variable, visit, regimen, visit by regimen as factors, and POSNA-PODCI at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 40||||0.1132
72325823|NCT02163577|144175062|SUPERIORITY|||||||0.2558||||||GEE model includes change in POSNA-PODCI score as the dependent variable, visit, regimen, visit by regimen as factors, and POSNA-PODCI at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 64||||0.2558
72325824|NCT02163577|144175062|SUPERIORITY|||||||0.0814||||||GEE model includes change in POSNA-PODCI score as the dependent variable, visit, regimen, visit by regimen as factors, and POSNA-PODCI at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 64||||0.0814
72325825|NCT02163577|144175062|SUPERIORITY|||||||0.0093||||||GEE model includes change in POSNA-PODCI score as the dependent variable, visit, regimen, visit by regimen as factors, and POSNA-PODCI at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 160||||0.0093
72325826|NCT02163577|144175062|SUPERIORITY||||||<|0.0001||||||GEE model includes change in POSNA-PODCI score as the dependent variable, visit, regimen, visit by regimen as factors, and POSNA-PODCI at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 160||||< 0.0001
72325827|NCT02163577|144175063|SUPERIORITY||||||<|0.0001||||||GEE model includes change in POSNA-PODCI score as the dependent variable, visit, regimen, visit by regimen as factors, and POSNA-PODCI at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 40||||< 0.0001
72325828|NCT02163577|144175063|SUPERIORITY|||||||0.0006||||||GEE model includes change in POSNA-PODCI score as the dependent variable, visit, regimen, visit by regimen as factors, and POSNA-PODCI at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 40||||0.0006
72325829|NCT02163577|144175063|SUPERIORITY|||||||0.026||||||GEE model includes change in POSNA-PODCI score as the dependent variable, visit, regimen, visit by regimen as factors, and POSNA-PODCI at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 64||||0.0260
72325830|NCT02163577|144175063|SUPERIORITY||||||<|0.0001||||||GEE model includes change in POSNA-PODCI score as the dependent variable, visit, regimen, visit by regimen as factors, and POSNA-PODCI at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 64||||< 0.0001
72325831|NCT02163577|144175063|SUPERIORITY||||||<|0.0001||||||GEE model includes change in POSNA-PODCI score as the dependent variable, visit, regimen, visit by regimen as factors, and POSNA-PODCI at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 160||||< 0.0001
72325832|NCT02163577|144175063|SUPERIORITY||||||<|0.0001||||||GEE model includes change in POSNA-PODCI score as the dependent variable, visit, regimen, visit by regimen as factors, and POSNA-PODCI at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 160||||< 0.0001
72325833|NCT02163577|144175067|SUPERIORITY|||||||0.0003|||||||one sample t test|||Week 40||||0.0003
72325834|NCT02163577|144175067|SUPERIORITY|||||||0.0021|||||||one sample t test|||Week 40||||0.0021
72325835|NCT02163577|144175067|SUPERIORITY||||||<|0.0001|||||||one sample t test|||Week 64||||< 0.0001
72325836|NCT02163577|144175067|SUPERIORITY||||||<|0.0001|||||||one sample t test|||Week 64||||< 0.0001
72325837|NCT02163577|144175067|SUPERIORITY||||||<|0.0001|||||||one sample t test|||Week 160||||< 0.0001
72325838|NCT02163577|144175067|SUPERIORITY||||||<|0.0001|||||||one sample t test|||Week 160||||< 0.0001
72325839|NCT01343888|144175076|SUPERIORITY_OR_OTHER||Koch's method|27.5|||<|0.0001|TWO_SIDED|95.0|17.9|37.0||adjusted for genotype and race|Cochran-Mantel-Haenszel||adjusted for genotype and race using Koch's method, with continuity correction|||37.0|17.9|<0.0001
72325840|NCT01343888|144175076|SUPERIORITY_OR_OTHER||Koch's methond|28.6|||<|0.0001|TWO_SIDED|95.0|19.0|38.2||adjusted for genotype and race|Cochran-Mantel-Haenszel||adjusted for genotype and race using Koch's method, with continuity correction|||38.2|19.0|<0.0001
72325841|NCT01343888|144175076|SUPERIORITY_OR_OTHER||Koch's method|-1.0|||||TWO_SIDED|95.0|-7.9|5.8|||||adjusted for genotype and race using Koch's method, with continuity correction|||5.8|-7.9|
72325842|NCT01343888|144175077|SUPERIORITY_OR_OTHER||Koch's method|27.1|||<|0.0001|TWO_SIDED|95.0|17.5|36.7||adjusted for genotype and race|Cochran-Mantel-Haenszel||adjusted for genotype and race using Koch's method, with continuity correction|||36.7|17.5|<0.0001
72325843|NCT01343888|144175077|SUPERIORITY_OR_OTHER||Koch's method|27.8|||<|0.0001|TWO_SIDED|95.0|18.2|37.4||adjusted for genotype and race|Cochran-Mantel-Haenszel||adjusted for genotype and race using Koch's method, with continuity correction|||37.4|18.2|<0.0001
72325844|NCT01343888|144175077|SUPERIORITY_OR_OTHER||Koch's method|-0.6|||||TWO_SIDED|95.0|-7.6|6.3|||||adjusted for genotype and race using Koch's method, with continuity correction|||6.3|-7.6|
72325845|NCT01331681|144175091|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|9.3|||<|0.0001|TWO_SIDED|97.5|6.5|12.0||Significance level alpha=0.025 for two sided test to adjust for multiplicity. Since this p-value was below the significance level of 0.025, the fixed sequence testing did continue with the first secondary endpoint.|ANCOVA|Treatment group and geographic region (Japan vs. Non-Japan) as factors and baseline value as covariate.|Least square (LS) mean difference from ANCOVA. The estimate is calculated as EYLEA minus Laser. A positive value indicates a result in favor of EYLEA.|Hypothesis: Mean change identical in both groups||12.0|6.5|<0.0001
72609377|NCT00607893|144747566|OTHER||Mean Difference (Final Values)|0.14||||0.92|TWO_SIDED|95.0|-2.6|2.87|||Regression, Linear|||||2.87|-2.60|0.92
72325846|NCT01331681|144175091|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|9.1|||<|0.0001|TWO_SIDED|97.5|6.3|11.8||Significance level alpha=0.025 for two sided test to adjust for multiplicity. Since this p-value was below the significance level of 0.025, the fixed sequence testing did continue with the first secondary endpoint.|ANCOVA|Treatment group and geographic region (Japan vs. Non-Japan) as factors and baseline value as covariate.|LS mean difference from ANCOVA. The estimate is calculated as EYLEA minus Laser. A positive value indicates a result in favor of EYLEA.|Hypothesis: Mean change identical in both groups||11.8|6.3|<0.0001
72325847|NCT01331681|144175092|SUPERIORITY_OR_OTHER_LEGACY||CMH adjusted difference|28.7|||<|0.0001|TWO_SIDED|97.5|15.8|41.6||Significance level alpha=0.025 for two sided test to adjust for multiplicity. Since this p-value and the preceding ones were below the significance level of 0.025, the fixed sequence testing did continue with the second secondary endpoint.|Cochran-Mantel-Haenszel|Stratifying by geographic region (Japan vs non-Japan).|The estimate is calculated as EYLEA minus Laser. A positive value indicates a result in favor of EYLEA.|Hypothesis: Probability to gain \>= 10 letters identical in both groups||41.6|15.8|<0.0001
72325848|NCT01331681|144175092|SUPERIORITY_OR_OTHER_LEGACY||CMH adjusted difference|27.5|||<|0.0001|TWO_SIDED|97.5|14.6|40.5||Significance level alpha=0.025 for two sided test to adjust for multiplicity. Since this p-value and the preceding ones were below the significance level of 0.025, the fixed sequence testing did continue with the second secondary endpoint.|Cochran-Mantel-Haenszel|Stratifying by geographic region (Japan vs non-Japan).|The estimate is calculated as EYLEA minus Laser. A positive value indicates a result in favor of EYLEA.|Hypothesis: Probability to gain \>= 10 letters identical in both groups||40.5|14.6|<0.0001
72325849|NCT01331681|144175093|SUPERIORITY_OR_OTHER_LEGACY||CMH adjusted difference|23.3|||<|0.0001|TWO_SIDED|97.5|12.6|33.9||Significance level alpha=0.025 for two sided test to adjust for multiplicity. Since this p-value and the preceding ones were below the significance level of 0.025, the fixed sequence testing did continue with the third secondary endpoint.|Cochran-Mantel-Haenszel|Stratifying by geographic region (Japan vs non-Japan).|The estimate is calculated as EYLEA minus Laser. A positive value indicates a result in favor of EYLEA.|Hypothesis: Probability to gain \>= 15 letters identical in both groups||33.9|12.6|<0.0001
72325850|NCT01331681|144175093|SUPERIORITY_OR_OTHER_LEGACY||CMH adjusted difference|24.2|||<|0.0001|TWO_SIDED|97.5|13.5|34.9||Significance level alpha=0.025 for two sided test to adjust for multiplicity. Since this p-value and the preceding ones were below the significance level of 0.025, the fixed sequence testing did continue with the third secondary endpoint.|Cochran-Mantel-Haenszel|Stratifying by geographic region (Japan vs non-Japan).|The estimate is calculated as EYLEA minus Laser. A positive value indicates a result in favor of EYLEA.|Hypothesis: Probability to gain \>= 15 letters identical in both groups||34.9|13.5|<0.0001
72325851|NCT01331681|144175094|SUPERIORITY_OR_OTHER_LEGACY||CMH adjusted difference|25.8|||<|0.0001|TWO_SIDED|97.5|12.2|39.4||Significance level alpha=0.025 for two sided test to adjust for multiplicity. Since this p-value and the preceding ones were below the significance level of 0.025, the fixed sequence testing did continue with the fourth secondary endpoint.|Cochran-Mantel-Haenszel|Stratifying by geographic region (Japan vs non-Japan).|The estimate is calculated as EYLEA minus Laser. A positive value indicates a result in favor of EYLEA.|Hypothesis: Probability to improve by \>= 2 steps identical in both groups||39.4|12.2|<0.0001
72325852|NCT01331681|144175094|SUPERIORITY_OR_OTHER_LEGACY||CMH adjusted difference|19.3||||0.0006|TWO_SIDED|97.5|6.6|32.1||Significance level alpha=0.025 for two sided test to adjust for multiplicity. Since this p-value and the preceding ones were below the significance level of 0.025, the fixed sequence testing did continue with the fourth secondary endpoint.|Cochran-Mantel-Haenszel|Stratifying by geographic region (Japan vs non-Japan).|The estimate is calculated as EYLEA minus Laser. A positive value indicates a result in favor of EYLEA.|Hypothesis: Probability to improve by \>= 2 steps identical in both groups||32.1|6.6|0.0006
72325853|NCT01331681|144175095|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-157.0|||<|0.0001|TWO_SIDED|97.5|-190.9|-123.1||Significance level alpha=0.025 for two sided test to adjust for multiplicity. Since this p-value and the preceding ones were below the significance level of 0.025, the fixed sequence testing did continue with the fifth secondary endpoint.|ANCOVA|Treatment group and geographic region (Japan vs. Non-Japan) as factors and baseline value as covariate.|LS mean difference from ANCOVA. The estimate is calculated as EYLEA minus Laser. A positive value indicates a result in favor of EYLEA.|Hypothesis: Mean change identical in both groups||-123.1|-190.9|<0.0001
72325854|NCT01331681|144175095|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-142.8|||<|0.0001|TWO_SIDED|97.5|-179.3|-106.3||Significance level alpha=0.025 for two sided test to adjust for multiplicity. Since this p-value and the preceding ones were below the significance level of 0.025, the fixed sequence testing did continue with the fifth secondary endpoint.|ANCOVA|Treatment group and geographic region (Japan vs. Non-Japan) as factors and baseline value as covariate|LS mean difference from ANCOVA. The estimate is calculated as EYLEA minus Laser. A negative value indicates a result in favor of EYLEA.|Hypothesis: Mean change identical in both groups||-106.3|-179.3|<0.0001
72417905|NCT00951483|144346169|SUPERIORITY_OR_OTHER||z-score|-4.544|||<|0.001|TWO_SIDED||||||Wilcoxon signed rank test|||The null hypothesis is that there is no difference between the intervention cohort's baseline HAM-D-7 score and end of treatment (i.e., 12 week) HAM-D-7 score.||||<.001
72609378|NCT00607893|144747567|OTHER||Mean Difference (Final Values)|0.21||||0.55|TWO_SIDED|95.0|-0.48|0.91|||Regression, Linear|||||0.91|-0.48|0.55
72609379|NCT00607893|144747568|OTHER||Mean Difference (Final Values)|0.38||||0.17|TWO_SIDED|95.0|-0.16|0.92|||Regression, Linear|||||0.92|-0.16|0.17
72609380|NCT00607893|144747569|OTHER||Mean Difference (Final Values)|2.4||||0.076|TWO_SIDED|95.0|-0.26|5.07|||Regression, Linear|||||5.07|-0.26|0.076
72609381|NCT00607893|144747570|OTHER||Mean Difference (Final Values)|0.062||||0.019|TWO_SIDED|95.0|0.01|0.11|||Regression, Linear||sIL-6R was log-transformed before analysis. The estimation parameter shows the log-transformed mean difference of the absolute change between groups, while the least square means of two groups are transformed back for presentation.|||0.11|0.010|0.019
72609382|NCT00607893|144747571|OTHER||Mean Difference (Final Values)|0.17||||0.68|TWO_SIDED|95.0|-0.64|0.99|||Regression, Linear|||||0.99|-0.64|0.68
72609383|NCT00607893|144747572|OTHER||Mean Difference (Final Values)|1.35||||0.59|TWO_SIDED|95.0|-3.6|6.31|||Regression, Linear|||||6.31|-3.60|0.59
72609384|NCT00607893|144747573|OTHER||Mean Difference (Final Values)|6.93|||<|0.001|TWO_SIDED|95.0|3.04|10.81|||Regression, Linear|||||10.81|3.04|<0.001
72417906|NCT00951483|144346170|SUPERIORITY_OR_OTHER||z-score|-4.627|||<|0.001|TWO_SIDED||||||Wilcoxon signed rank test|||The null hypothesis is that there is no difference between the intervention cohort's baseline HAMD-17 score and end of treatment (i.e., 12 week) HAMD-17 score.||||<.001
72417907|NCT00951483|144346171|SUPERIORITY_OR_OTHER||z-score|-4.624|||<|0.001|TWO_SIDED||||||Wilcoxon signed rank test|||The null hypothesis is that there is no difference between the intervention cohort's baseline HAMD-21 score and end of treatment (i.e., 12 week) HAMD-21 score.||||<.001
72417908|NCT00951483|144346172|SUPERIORITY_OR_OTHER||z-score|-4.51|||<|0.001|TWO_SIDED||||||Wilcoxon signed rank test|||The null hypothesis is that there is no difference between the intervention cohort's baseline HAM-A score and end of treatment (i.e., 12 week) HAM-A score.||||<.001
72417909|NCT00951483|144346173|SUPERIORITY_OR_OTHER||z-score|-4.435|||<|0.001|TWO_SIDED||||||Wilcoxon signed rank test|||The null hypothesis is that there is no difference between the intervention cohort's baseline BDI score and end of treatment (i.e., 12 week) BDI score.||||<.001
72609385|NCT02669849|144747574|SUPERIORITY||Least Squares (LS) Mean Difference|-0.69||||0.7519|TWO_SIDED|95.0|-5.08|3.69|||Mixed-effects model for repeated measure|||||3.69|-5.08|0.7519
72609386|NCT02543840|144747583|SUPERIORITY||Mean Difference (Final Values)|0.2|||<|0.01|TWO_SIDED|95.0|-1.26|1.5||Adjusted for multiple comparisons (Bonferroni four comparisons).|Mixed Models Analysis|||||1.5|-1.26|<0.01
72609387|NCT02543840|144747583|SUPERIORITY||Mean Difference (Final Values)|5.03|||<|0.001|TWO_SIDED|95.0|2.24|7.82||Adjusted for comparisons (Bonferroni for 4 comparisons.)|Regression, Linear|||Among Veteran participants,we used a linear contrast comparing a) those with complex clinical presentations, defined as receiving treatment for three or more mental health diagnoses in the prior year to b) those with two or fewer diagnoses during the facilitation year from T0 to T12..||7.82|2.24|<0.001
72609388|NCT02543840|144747584|SUPERIORITY||Mean Difference (Final Values)|1.2|||<|0.04|TWO_SIDED|95.0|0.04|2.3||Adjusted for comparison (Bonferroni for four comparisons.)|Mixed Models Analysis|||||2.3|0.04|<0.04
72609389|NCT02543840|144747585|SUPERIORITY||Mean Difference (Final Values)|0.6|||>|0.05|TWO_SIDED|95.0|-0.2|0.9|||Mixed Models Analysis|||||0.9|-0.2|>0.05
72609390|NCT02543840|144747586|SUPERIORITY||Mean Difference (Final Values)|0.5|||>|0.05|TWO_SIDED|95.0|-1.3|2.3|||Mixed Models Analysis|||||2.3|-1.3|>0.05
72609391|NCT02543840|144747587|SUPERIORITY||Mean Difference (Final Values)|0.0|||>|0.05|TWO_SIDED|95.0|-0.6|0.8|||Mixed Models Analysis|||||0.8|-0.6|>0.05
72609392|NCT02543840|144747588|SUPERIORITY||Mean Difference (Final Values)|0.005|||>|0.05|TWO_SIDED|95.0|-0.074|0.084|||t-test, 2 sided|Paired.||||0.084|-0.074|>0.05
72609393|NCT02543840|144747589|SUPERIORITY||Mean Difference (Final Values)|0.011|STANDARD_DEVIATION|0.206|>|0.05|TWO_SIDED|95.0|-0.056|0.077|||t-test, 2 sided|Paired.||||0.077|-0.056|>0.05
72325855|NCT01331681|144175096|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.41||||0.2208|TWO_SIDED|97.5|-2.01|6.82||Significance level alpha=0.025 for two sided test to adjust for multiplicity. Since this p-value is not below of 0.025, the fixed sequence testing stops here. The sixth secondary endpoint cannot be tested confirmatory.|ANCOVA|Treatment group and geographic region (Japan vs. Non-Japan) as factors and baseline value as covariate.|LS mean difference from ANCOVA. The estimate is calculated as EYLEA minus Laser. A positive value indicates a result in favor of EYLEA.|Hypothesis: Mean change identical in both groups||6.82|-2.01|0.2208
72325856|NCT01331681|144175096|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.21||||0.5537|TWO_SIDED|97.5|-5.79|3.37||Significance level alpha=0.025 for two sided test to adjust for multiplicity. Since this p-value is not below of 0.025, the fixed sequence testing stops here. The sixth secondary endpoint cannot be tested confirmatory.|ANCOVA|Treatment group and geographic region (Japan vs. Non-Japan) as factors and baseline value as covariate.|LS mean difference from ANCOVA. The estimate is calculated as EYLEA minus Laser. A positive value indicates a result in favor of EYLEA.|Hypothesis: Mean change identical in both groups||3.37|-5.79|0.5537
72325857|NCT01331681|144175097|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.19||||0.5138|TWO_SIDED|97.5|-5.29|2.91|||ANCOVA||LS mean difference from ANCOVA. The estimate is calculated as EYLEA minus Laser. A positive value indicates a result in favor of EYLEA.|Hypothesis: Mean change identical in both groups||2.91|-5.29|0.5138
72325858|NCT01331681|144175097|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.37||||0.8498|TWO_SIDED|97.5|-4.79|4.05|||ANCOVA||LS mean difference from ANCOVA. The estimate is calculated as EYLEA minus Laser. A positive value indicates a result in favor of EYLEA.|Hypothesis: Mean change identical in both groups||4.05|-4.79|0.8498
72325859|NCT04577781|144175116|SUPERIORITY||Least Squares (LS) Mean difference|-0.05|STANDARD_ERROR_OF_MEAN|0.353||0.885|TWO_SIDED|90.0|-0.66|0.55||Mixed model repeated measure (MMRM) with treatment-by-visit interaction and baseline-by-visit interaction as fixed effects (with an unstructured variance-covariance matrix).|MMRM|||||0.55|-0.66|0.885
72325860|NCT00114127|144175119|SUPERIORITY_OR_OTHER||||||<|0.132||95.0|||||t-test, 2 sided|||||||<0.132
72325861|NCT00114127|144175120|SUPERIORITY_OR_OTHER||||||<|0.292||95.0|||||t-test, 2 sided|||||||<.292
72325862|NCT00881894|144175121|NON_INFERIORITY_OR_EQUIVALENCE|If the 90% Confidence Interval for the ratio of geometric LS- Means is included within 0.8- 1.25, the patches are considered bioequivalent.|ratio of geometric LS- Means|0.9864||||||90.0|0.9103|1.0688|||ANOVA|ANOVA for log- transformed values has been used as the basis for calculation of point estimates (LS- Means) and Confidence Intervals (CIs).|Bioequivalence is concluded if the 90% CIs for the ratio Treatment A/ Treatment B are fully included in the acceptance range from 0.8- 1.25 for AUC(0-tz) and Cmax.|Bioequivalence testing by using the 90% Confidence Interval (CI).||1.0688|0.9103|
72325863|NCT00881894|144175122|NON_INFERIORITY_OR_EQUIVALENCE|If the 90% Confidence Interval for the ratio of geometric LS- Means is included within 0.8- 1.25, the patches are considered bioequivalent.|ratio of geometric LS- Means|0.9584||||||90.0|0.8861|1.0367|||ANOVA|ANOVA for log- transformed values has been used as the basis for calculation of point estimates (LS- Means) and Confidence Intervals (CIs).|Bioequivalence is concluded if the 90% CIs for the ratio Treatment A/ Treatment B are fully included in the acceptance range from 0.8- 1.25 for AUC(0-tz) and Cmax.|Bioequivalence testing by using the 90% Confidence Interval (CI).||1.0367|0.8861|
72417910|NCT00951483|144346174|SUPERIORITY_OR_OTHER||z-score|-3.911|||<|0.001|TWO_SIDED||||||Wilcoxon signed rank test|||The null hypothesis is that there is no difference between the intervention cohort's baseline PSS-14 score and end of treatment (i.e., 12 week) PSS-14 score.||||<.001
72325864|NCT00881894|144175123|NON_INFERIORITY_OR_EQUIVALENCE|If the 90% Confidence Interval for the ratio of geometric LS- Means is included within 0.8- 1.25, the patches are considered bioequivalent.|ratio of geometric LS- Means|0.9896||||||90.0|0.9179|1.0671|||ANOVA|ANOVA for log- transformed values has been used as the basis for calculation of point estimates (LS- Means) and Confidence Intervals (CIs).||Bioequivalence testing by using the 90% Confidence Interval (CI).||1.0671|0.9179|
72609394|NCT02543840|144747590|SUPERIORITY||Mean Difference (Final Values)|0.153|||<|0.001|TWO_SIDED|95.0|0.044|0.262|||t-test, 2 sided|Paired||||0.262|0.044|<0.001
72325865|NCT01822665|144175147|SUPERIORITY_OR_OTHER||Least squares mean difference|-1.11|||<|0.0001|TWO_SIDED|95.0|-1.63|-0.59||No multiple comparisons were carried out.|t-test, 2 sided|Period and treatment were included in the model as fixed effects, while subjects were a random effect.|Difference was first named treatment minus second named treatment, such that a positive difference favors the first named treatment.|Null hypothesis considered no significant difference in mean endoscopy score of gastric mucosal damage between two treatments.||-0.59|-1.63|<0.0001
72325866|NCT01822665|144175148|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.7||||0.0095|TWO_SIDED|95.0|-1.23|-0.18|||t-test, 2 sided|Period and treatment were included in the model as fixed effects, while subjects were a random effect.|Difference was first named treatment minus second named treatment, such that a positive difference favors the first named treatment.|Null hypothesis considered no significant difference in mean endoscopy score of gastric mucosal damage between two treatments.||-0.18|-1.23|0.0095
72417911|NCT02342886|144346184|NON_INFERIORITY|Non-inferiority was assessed using the upper bound of the two-sided 95% confidence interval (CI) for the difference between the percentage of patients who are classified as having an unfavourable status on the intervention (6 months moxifloxacin + 200 mg PA-824 + pyrazinamide) and the control regimen (2 months HRZE/ 4 months HR). The intervention was considered to be non-inferior to the control arm if the upper bound 95% CI was \< 12%.|Treatment difference: unfavourable rate|9.88|||||TWO_SIDED|95.0|-4.13|23.89|||||(DS-TB: 6 Months Moxifloxacin + PA-824 (200 mg) + Pyrazinamide) - (DS-TB: 2 Months HRZE/ 4 Months HR).|||23.89|-4.13|
72609395|NCT02543840|144747591|SUPERIORITY||Mean Difference (Final Values)|0.186|||<|0.01|TWO_SIDED|95.0|0.083|0.289|||t-test, 2 sided|Paired.||||0.289|0.083|<0.01
72609396|NCT02543840|144747592|SUPERIORITY||Mean Difference (Final Values)|-0.12|||<|0.001|TWO_SIDED|95.0|-0.16|-0.07||Repeated patient binary outcome models for hospitalized (0/1) across 8 quarters.|Mixed Models Analysis|Adjusted (Bonferroni four comparisons).||||-0.07|-0.16|<0.001
72609397|NCT01248416|144747593|SUPERIORITY||||||<|0.006|||||||ANCOVA|||||||<0.006
72609398|NCT01248416|144747595|SUPERIORITY|||||||0.906|||||||ANOVA|||||||0.906
72609399|NCT01248416|144747596|SUPERIORITY|||||||0.015|||||||ANOVA|||||||0.015
72609400|NCT01248416|144747598|SUPERIORITY||||||<|0.0001|||||||ANOVA|||||||<0.0001
72609401|NCT01248416|144747599|SUPERIORITY||||||<|0.0001|||||||ANOVA|||||||<0.0001
72609402|NCT01248416|144747600|SUPERIORITY|||||||0.0003|||||||ANCOVA|||||||0.0003
72417912|NCT02342886|144346185|NON_INFERIORITY|Non-inferiority was assessed using the upper bound of the two-sided 95% CI for the difference between the percentage of patients who are classified as having an unfavourable status on the intervention (6 months moxifloxacin + 200 mg PA-824 + pyrazinamide) and the control regimen (2 months HRZE/ 4 months HR). The intervention was considered to be non-inferior to the control arm if the upper bound 95% CI was \< 12%.|Treatment difference: unfavourable rate|6.62|||||TWO_SIDED|95.0|-2.15|15.4|||||(DS-TB: 6 Months Moxifloxacin + PA-824 (200 mg) + Pyrazinamide) - (DS-TB: 2 Months HRZE/ 4 Months HR).|||15.40|-2.15|
72417913|NCT00540124|144346187|SUPERIORITY_OR_OTHER|||||||0.073||95.0||||P-value for 12 Week Change. Change=Endpoint minus baseline. P-values are from an ANCOVA with effects for treatment, prior alpha blocker use (yes/no), and baseline value, and were not adjusted for multiple comparisons.|ANCOVA|||||||0.073
72417914|NCT00540124|144346187|SUPERIORITY_OR_OTHER|||||||0.186||95.0||||P-value for 12 Week Change. Change=Endpoint minus baseline. P-values are from an ANCOVA with effects for treatment, prior alpha blocker use (yes/no), and baseline value, and were not adjusted for multiple comparisons.|ANCOVA|||||||0.186
72417915|NCT00540124|144346188|SUPERIORITY_OR_OTHER|||||||0.155||95.0||||P-value for 4 Week Change. Change=Endpoint minus baseline. P-values are from an ANCOVA with effects for treatment, prior alpha blocker use (yes/no), and baseline value, and were not adjusted for multiple comparisons.|ANCOVA|||||||0.155
72417916|NCT00540124|144346188|SUPERIORITY_OR_OTHER|||||||0.155||95.0||||P-value for 4 Week Change. Change=Endpoint minus baseline. P-values are from an ANCOVA with effects for treatment, prior alpha blocker use (yes/no), and baseline value, and were not adjusted for multiple comparisons.|ANCOVA|||||||0.155
72417917|NCT00540124|144346188|SUPERIORITY_OR_OTHER|||||||0.108||95.0||||P-value for 8 Week Change. Change=Endpoint minus baseline. P-values are from an ANCOVA with effects for treatment, prior alpha blocker use (yes/no), and baseline value, and were not adjusted for multiple comparisons.|ANCOVA|||||||0.108
72417918|NCT00540124|144346188|SUPERIORITY_OR_OTHER|||||||0.112||95.0||||P-value for 8 Week Change. Change=Endpoint minus baseline. P-values are from an ANCOVA with effects for treatment, prior alpha blocker use (yes/no), and baseline value, and were not adjusted for multiple comparisons.|ANCOVA|||||||0.112
72417919|NCT00540124|144346189|SUPERIORITY_OR_OTHER|||||||0.137||95.0||||P-value for 4 Week Change. Change=Endpoint minus baseline. P-values are from ANCOVA with effects for treatment, prior alpha blocker use (yes/no), time (visit), baseline value, and time\*treatment interaction. Model used an unstructured covariance.|ANCOVA|||||||0.137
72417920|NCT00540124|144346189|SUPERIORITY_OR_OTHER|||||||0.009||95.0||||P-value for 4 Week Change. Change=Endpoint minus baseline. P-values are from ANCOVA with effects for treatment, prior alpha blocker use (yes/no), time (visit), baseline value, and time\*treatment interaction. Model used an unstructured covariance.|ANCOVA|||||||0.009
72609403|NCT04745351|144747602|SUPERIORITY||Hazard Ratio (HR)|0.816||||0.6132|TWO_SIDED|95.0|0.504|1.321||P-value was calculated from stratified log-rank test, stratified by the baseline stratification factors.|Log Rank|||||1.321|0.504|0.6132
72417921|NCT00540124|144346189|SUPERIORITY_OR_OTHER|||||||0.118||95.0||||P-value for 8 Week Change. Change=Endpoint minus baseline. P-values are from ANCOVA with effects for treatment, prior alpha blocker use (yes/no), time (visit), baseline value, and time\*treatment interaction. Model used an unstructured covariance.|ANCOVA|||||||0.118
72417922|NCT00540124|144346189|SUPERIORITY_OR_OTHER|||||||0.018||95.0||||P-value for 8 Week Change. Change=Endpoint minus baseline. P-values are from ANCOVA with effects for treatment, prior alpha blocker use (yes/no), time (visit), baseline value, and time\*treatment interaction. Model used an unstructured covariance.|ANCOVA|||||||0.018
72609404|NCT04745351|144747603|SUPERIORITY||Hazard Ratio (HR)|0.83||||0.3881|TWO_SIDED|95.0|0.497|1.388||P-value was calculated from stratified log-rank test stratified by the baseline stratification factors.|Log Rank|||||1.388|0.497|0.3881
72417923|NCT00540124|144346189|SUPERIORITY_OR_OTHER|||||||0.207||95.0||||P-value for 12 Week Change. Change=Endpoint minus baseline. P-values are from ANCOVA with effects for treatment, prior alpha blocker use (yes/no), time (visit), baseline value, and time\*treatment interaction. Model used an unstructured covariance.|ANCOVA|||||||0.207
72417924|NCT00540124|144346189|SUPERIORITY_OR_OTHER|||||||0.581||95.0||||P-value for 12 Week Change. Change=Endpoint minus baseline. P-values are from ANCOVA with effects for treatment, prior alpha blocker use (yes/no), time (visit), baseline value, and time\*treatment interaction. Model used an unstructured covariance.|ANCOVA|||||||0.581
72417925|NCT00540124|144346190|SUPERIORITY_OR_OTHER|||||||0.306||95.0||||P-value for 4 Week Change. Change=Endpoint minus baseline. P-values are from ANCOVA with effects for treatment, prior alpha blocker use (yes/no), time (visit), baseline value, and time\*treatment interaction. Model used an unstructured covariance.|ANCOVA|||||||0.306
72609405|NCT04745351|144747604|SUPERIORITY||Hazard Ratio (HR)|1.043||||0.9116|TWO_SIDED|95.0|0.493|2.207||The treatment effect p-value was calculated using Cox model with death as the competing risk and baseline stratification factors as covariates.|Regression, Cox|||||2.207|0.493|0.9116
72609406|NCT04745351|144747607|SUPERIORITY|||||||0.8541||||||P-value was analysed from proportional odds model including treatment as the independent variable.|Proportional odds model|||||||0.8541
72609407|NCT04745351|144747608|SUPERIORITY|||||||0.4974||||||P-value was analysed from proportional odds model including treatment as the independent variable.|Proportional odds model|||||||0.4974
72417926|NCT00540124|144346190|SUPERIORITY_OR_OTHER|||||||0.762||95.0||||P-value for 4 Week Change. Change=Endpoint minus baseline. P-values are from ANCOVA with effects for treatment, prior alpha blocker use (yes/no), time (visit), baseline value, and time\*treatment interaction. Model used an unstructured covariance.|ANCOVA|||||||0.762
72609408|NCT04745351|144747609|SUPERIORITY|||||||0.4283||||||P-value was calculated based on Wilcoxon rank sum test.|Wilcoxon (Mann-Whitney)|||||||0.4283
72609409|NCT04745351|144747610|SUPERIORITY||Relative risk|0.89||||0.2773|TWO_SIDED|95.0|0.731|1.091||The treatment effect p-value was calculated using Cochran-Mantel-Haenszel (CMH) analysis including baseline stratification factors.|Cochran-Mantel-Haenszel|||||1.091|0.731|0.2773
72609410|NCT04745351|144747611|SUPERIORITY||Relative risk|0.97||||0.7538|TWO_SIDED|95.0|0.819|1.155||The treatment effect p-value was calculated using CMH analysis including baseline stratification factors.|Cochran-Mantel-Haenszel|||||1.155|0.819|0.7538
72609411|NCT02014272|144747621|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|95.45|||||TWO_SIDED|90.0|92.07|98.94||||||Natural log transformed AUClast of rifampicin was analyzed using mixed effects model with sequence,period and treatment as fixed effects and participant within sequence as random effect.The adjusted mean differences and 90% confidence intervals(CIs) for the differences were exponentiated to provide estimates of ratio of adjusted geometric means(Test/Reference) and 90% CIs for the ratios,where FDC tablet were test and single drugs were reference.Values were back-transformed from the log scale.||98.94|92.07|
72609412|NCT02014272|144747621|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|103.45|||||TWO_SIDED|90.0|99.33|107.75||||||Natural log transformed AUClast of isoniazid was analyzed using mixed effects model with sequence,period and treatment as fixed effects and participant within sequence as random effect.The adjusted mean differences and 90% confidence intervals(CIs) for the differences were exponentiated to provide estimates of ratio of adjusted geometric means(Test/Reference) and 90% CIs for the ratios,where FDC tablet were test and single drugs were reference.Values were back-transformed from the log scale.||107.75|99.33|
72609413|NCT02014272|144747622|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|91.63|||||TWO_SIDED|90.0|83.13|101.01||||||Natural log transformed Cmax of rifampicin was analyzed using mixed effects model with sequence,period and treatment as fixed effects and participant within sequence as random effect.The adjusted mean differences and 90% confidence intervals(CIs) for the differences were exponentiated to provide estimates of ratio of adjusted geometric means(Test/Reference) and 90% CIs for the ratios,where FDC tablet were test and single drugs were reference.Values were back-transformed from the log scale.||101.01|83.13|
72609414|NCT02014272|144747622|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|107.58|||||TWO_SIDED|90.0|96.07|120.47||||||Natural log transformed Cmax of isoniazid was analyzed using mixed effects model with sequence,period and treatment as fixed effects and participant within sequence as random effect.The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of ratio of adjusted geometric means(Test/Reference) and 90% CIs for the ratios,where FDC tablet were test and single drugs were reference.Values were back-transformed from the log scale.||120.47|96.07|
72609415|NCT02014272|144747623|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|95.92|||||TWO_SIDED|90.0|92.54|99.43||||||Natural log transformed AUC(0 - ∞) of rifampicin was analyzed using mixed effects model with sequence,period and treatment as fixed effects and participant within sequence as random effect.The adjusted mean differences and 90% confidence intervals(CIs) for the differences were exponentiated to provide estimates of ratio of adjusted geometric means(Test/Reference) and 90% CIs for the ratios,where FDC tablet were test and single drugs were reference.Values were back-transformed from the log scale.||99.43|92.54|
72609416|NCT02014272|144747623|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|102.41|||||TWO_SIDED|90.0|98.76|106.19||||||Natural log transformed AUC(0 - ∞) of isoniazid was analyzed using mixed effects model with sequence,period and treatment as fixed effects and participant within sequence as random effect.The adjusted mean differences and 90% confidence intervals(CIs) for the differences were exponentiated to provide estimates of ratio of adjusted geometric means(Test/Reference) and 90% CIs for the ratios,where FDC tablet were test and single drugs were reference.Values were back-transformed from the log scale.||106.19|98.76|
72609417|NCT03499795|144747628|SUPERIORITY|||||||0.8633|||||||Clopper-Pearson|P-value was calculated based on the exact method of Clopper-Pearson and superiority was concluded if the one-sided p-value is \<0.05.||||||0.8633
72609418|NCT02741284|144747643|NON_INFERIORITY|A noninferiority margin of 30% (mean difference \<1.0 mmol/l) was pre-specified as it corresponds to an upper umbilical artery lactate cut-off value of 4.5 mmol/L, above which there is an increased risk of neonatal morbidity|Mean Difference (Final Values)|0.1||||0.69|TWO_SIDED|95.0|-0.5|0.7|||Wilcoxon (Mann-Whitney)|||||0.7|-0.5|0.69
72609419|NCT02741284|144747644|NON_INFERIORITY|Noninferiority margin 30%|Mean Difference (Final Values)|0.01|||<|0.05|TWO_SIDED|95.0|-0.01|0.03|||t-test, 2 sided|||pH||0.03|-0.01|<0.05
72417927|NCT00540124|144346190|SUPERIORITY_OR_OTHER|||||||0.203||95.0||||P-value for 8 Week Change. Change=Endpoint minus baseline. P-values are from ANCOVA with effects for treatment, prior alpha blocker use (yes/no), time (visit), baseline value, and time\*treatment interaction. Model used an unstructured covariance.|ANCOVA|||||||0.203
72609420|NCT02741284|144747645|SUPERIORITY||Risk Ratio (RR)|0.32|||<|0.05|TWO_SIDED|95.0|0.07|1.48|||Chi-squared|||Cesarean delivery||1.48|0.07|<0.05
72417928|NCT00540124|144346190|SUPERIORITY_OR_OTHER|||||||0.464||95.0||||P-value for 8 Week Change. Change=Endpoint minus baseline. P-values are from ANCOVA with effects for treatment, prior alpha blocker use (yes/no), time (visit), baseline value, and time\*treatment interaction. Model used an unstructured covariance.|ANCOVA|||||||0.464
72417929|NCT00540124|144346190|SUPERIORITY_OR_OTHER|||||||0.169||95.0||||P-value for 12 Week Change. Change=Endpoint minus baseline. P-values are from ANCOVA with effects for treatment, prior alpha blocker use (yes/no), time (visit), baseline value, and time\*treatment interaction. Model used an unstructured covariance.|ANCOVA|||||||0.169
72417930|NCT00540124|144346190|SUPERIORITY_OR_OTHER|||||||0.243||95.0||||P-value for 12 Week Change. Change=Endpoint minus baseline. P-values are from ANCOVA with effects for treatment, prior alpha blocker use (yes/no), time (visit), baseline value, and time\*treatment interaction. Model used an unstructured covariance.|ANCOVA|||||||0.243
72417931|NCT00540124|144346191|SUPERIORITY_OR_OTHER|||||||0.206||95.0||||P-value for 4 Week Change. Change=Endpoint minus baseline. P-values are from ANCOVA with effects for treatment, prior alpha blocker use (yes/no), time (visit), baseline value, and time\*treatment interaction. Model used an unstructured covariance.|ANCOVA|||||||0.206
72417932|NCT00540124|144346191|SUPERIORITY_OR_OTHER|||||||0.457||95.0||||P-value for 4 Week Change. Change=Endpoint minus baseline. P-values are from ANCOVA with effects for treatment, prior alpha blocker use (yes/no), time (visit), baseline value, and time\*treatment interaction. Model used an unstructured covariance.|ANCOVA|||||||0.457
72417933|NCT00540124|144346191|SUPERIORITY_OR_OTHER|||||||0.892||95.0||||P-value for 8 Week Change. Change=Endpoint minus baseline. P-values are from ANCOVA with effects for treatment, prior alpha blocker use (yes/no), time (visit), baseline value, and time\*treatment interaction. Model used an unstructured covariance.|ANCOVA|||||||0.892
72417934|NCT00540124|144346191|SUPERIORITY_OR_OTHER|||||||0.593||95.0||||P-value for 8 Week Change. Change=Endpoint minus baseline. P-values are from ANCOVA with effects for treatment, prior alpha blocker use (yes/no), time (visit), baseline value, and time\*treatment interaction. Model used an unstructured covariance.|ANCOVA|||||||0.593
72417935|NCT00540124|144346191|SUPERIORITY_OR_OTHER|||||||0.887||95.0||||P-value for 12 Week Change. Change=Endpoint minus baseline. P-values are from ANCOVA with effects for treatment, prior alpha blocker use (yes/no), time (visit), baseline value, and time\*treatment interaction. Model used an unstructured covariance.|ANCOVA|||||||0.887
72417936|NCT00540124|144346191|SUPERIORITY_OR_OTHER|||||||0.762||95.0||||P-value for 12 Week Change. Change=Endpoint minus baseline. P-values are from ANCOVA with effects for treatment, prior alpha blocker use (yes/no), time (visit), baseline value, and time\*treatment interaction. Model used an unstructured covariance.|ANCOVA|||||||0.762
72417937|NCT00540124|144346192|SUPERIORITY_OR_OTHER|||||||0.691||95.0||||P-value for 12 Week Change. Change=Endpoint minus baseline. P-values are from an ANCOVA with effects for treatment, prior alpha blocker use (yes/no), and baseline value, and were not adjusted for multiple comparisons.|ANCOVA|||||||0.691
72417938|NCT00540124|144346192|SUPERIORITY_OR_OTHER|||||||0.415||95.0||||P-value for 12 Week Change. Change=Endpoint minus baseline. P-values are from an ANCOVA with effects for treatment, prior alpha blocker use (yes/no), and baseline value, and were not adjusted for multiple comparisons.|ANCOVA|||||||0.415
72417939|NCT00540124|144346193|SUPERIORITY_OR_OTHER|||||||0.176||95.0||||P-value based on Cochran-Mantel-Haenszel Test with modified ridit scores controlling for alpha block use (yes/no) and lower urinary tract symptom severity as stratification factors.|Cochran-Mantel-Haenszel|||||||0.176
72417940|NCT00540124|144346193|SUPERIORITY_OR_OTHER|||||||0.921||95.0||||P-value based on Cochran-Mantel-Haenszel Test with modified ridit scores controlling for alpha block use (yes/no) and lower urinary tract symptom severity as stratification factors.|Cochran-Mantel-Haenszel|||||||0.921
72417941|NCT00540124|144346194|SUPERIORITY_OR_OTHER|||||||0.429||95.0||||P-value based on Cochran-Mantel-Haenszel Test with modified ridit scores controlling for alpha block use (yes/no) and lower urinary tract symptom severity as stratification factors.|Cochran-Mantel-Haenszel|||||||0.429
72417942|NCT00540124|144346194|SUPERIORITY_OR_OTHER|||||||0.304||95.0||||P-value based on Cochran-Mantel-Haenszel Test with modified ridit scores controlling for alpha block use (yes/no) and lower urinary tract symptom severity as stratification factors.|Cochran-Mantel-Haenszel|||||||0.304
72417943|NCT00540124|144346195|SUPERIORITY_OR_OTHER|||||||0.254||95.0||||P-value for 12 Week Change Waking Voids. Change=Endpoint minus baseline. P-values for pairwise comparison of change difference based on Wilcoxon Rank Sum test.|Wilcoxon Rank Sum|||||||0.254
72417944|NCT00540124|144346195|SUPERIORITY_OR_OTHER|||||||0.359||95.0||||P-value for 12 Week Change Waking Voids. Change=Endpoint minus baseline. P-values for pairwise comparison of change difference based on Wilcoxon Rank Sum test.|Wilcoxon Rank Sum|||||||0.359
72417945|NCT00540124|144346195|SUPERIORITY_OR_OTHER|||||||0.098||95.0||||P-value for 12 Week Change Sleeping Voids. Change=Endpoint minus baseline. P-values for pairwise comparison of change difference based on Wilcoxon Rank Sum test.|Wilcoxon Rank Sum|||||||0.098
72417946|NCT00540124|144346195|SUPERIORITY_OR_OTHER|||||||0.632||95.0||||P-value for 12 Week Change Sleeping Voids. Change=Endpoint minus baseline. P-values for pairwise comparison of change difference based on Wilcoxon Rank Sum test.|Wilcoxon Rank Sum|||||||0.632
72417947|NCT00540124|144346195|SUPERIORITY_OR_OTHER|||||||0.102||95.0||||P-value for 12 Week Change Total Voids. Change=Endpoint minus baseline. P-values for pairwise comparison of change difference based on Wilcoxon Rank Sum test.|Wilcoxon Rank Sum|||||||0.102
72417948|NCT00540124|144346195|SUPERIORITY_OR_OTHER|||||||0.348||95.0||||P-value for 12 Week Change Total Voids. Change=Endpoint minus baseline. P-values for pairwise comparison of change difference based on Wilcoxon Rank Sum test.|Wilcoxon Rank Sum|||||||0.348
72417949|NCT00540124|144346196|SUPERIORITY_OR_OTHER|||||||0.208||95.0||||P-value for 12 Week Change. Change=Endpoint minus baseline. P-values for pairwise comparison of change difference based on Wilcoxon Rank Sum test.|Wilcoxon Rank Sum|||||||0.208
72417950|NCT00540124|144346196|SUPERIORITY_OR_OTHER|||||||0.985||95.0||||P-value for 12 Week Change. Change=Endpoint minus baseline. P-values for pairwise comparison of change difference based on Wilcoxon Rank Sum test.|Wilcoxon Rank Sum|||||||0.985
72417951|NCT00540124|144346197|SUPERIORITY_OR_OTHER|||||||0.385||95.0||||P-value for 12 Week Change Terminal Micturation Dribble. Change=Endpoint minus baseline. P-values for pairwise comparison of change difference based on Wilcoxon Rank Sum test.|Wilcoxon Rank Sum|||||||0.385
72609421|NCT02741284|144747645|SUPERIORITY||Risk Ratio (RR)|0.0|||<|0.05|TWO_SIDED|95.0|0.0|0.0|||Chi-squared|||Cesarean delivery for non reassuring fetal status||0|0|<0.05
72609422|NCT02741284|144747645|SUPERIORITY||Risk Ratio (RR)|5.65|||<|0.05|TWO_SIDED|95.0|0.71|45.2|||Chi-squared|||Operative vaginal delivery||45.20|0.71|<0.05
72325867|NCT01822665|144175148|SUPERIORITY_OR_OTHER||LS mean difference|0.19||||0.4794|TWO_SIDED|95.0|-0.34|0.72||No multiple comparisons were carried out.|t-test, 2 sided|Period and treatment were included in the model as fixed effects, while subjects were a random effect.|Difference was first named treatment minus second named treatment, such that a positive difference favors the first named treatment.|Null hypothesis considered no significant difference in mean endoscopy score of gastric mucosal damage between two treatments.||0.72|-0.34|0.4794
72325868|NCT01822665|144175148|SUPERIORITY_OR_OTHER||LS mean difference|0.4||||0.1429|TWO_SIDED|95.0|-0.14|0.95||No multiple comparisons were carried out.|t-test, 2 sided|Period and treatment were included in the model as fixed effects, while subjects were a random effect.|Difference was first named treatment minus second named treatment, such that a positive difference favors the first named treatment.|Null hypothesis considered no significant difference in mean endoscopy score of gastric mucosal damage between two treatments.||0.95|-0.14|0.1429
72325869|NCT01822665|144175148|SUPERIORITY_OR_OTHER||LS mean difference|1.3|||<|0.0001|TWO_SIDED|95.0|0.75|1.84||No multiple comparisons were carried out.|t-test, 2 sided|Period and treatment were included in the model as fixed effects, while subjects were a random effect.|Difference was first named treatment minus second named treatment, such that a positive difference favors the first named treatment.|Null hypothesis considered no significant difference in mean endoscopy score of gastric mucosal damage between two treatments.||1.84|0.75|<0.0001
72325870|NCT01822665|144175148|SUPERIORITY_OR_OTHER||LS mean difference|0.89||||0.002|TWO_SIDED|95.0|0.34|1.45||No multiple comparisons were carried out.|t-test, 2 sided|Period and treatment were included in the model as fixed effects, while subjects were a random effect.|Difference was first named treatment minus second named treatment, such that a positive difference favors the first named treatment.|Null hypothesis considered no significant difference in mean endoscopy score of gastric mucosal damage between two treatments.||1.45|0.34|0.0020
72325871|NCT01822665|144175149|SUPERIORITY_OR_OTHER||LS mean difference|-0.09||||0.6497|TWO_SIDED|95.0|-0.49|0.31||No multiple comparisons were carried out.|t-test, 2 sided|Period and treatment were included in the model as fixed effects, while subjects were a random effect.|Difference was first named treatment minus second named treatment, such that a positive difference favors the first named treatment.|Null hypothesis considered no significant difference in mean endoscopy score of duodenal mucosal damage between two treatments.||0.31|-0.49|0.6497
72325872|NCT01822665|144175149|SUPERIORITY_OR_OTHER||LS mean difference|-0.06||||0.7591|TWO_SIDED|95.0|-0.46|0.34||No multiple comparisons were carried out.|t-test, 2 sided|Period and treatment were included in the model as fixed effects, while subjects were a random effect.|Difference was first named treatment minus second named treatment, such that a positive difference favors the first named treatment.|Null hypothesis considered no significant difference in mean endoscopy score of duodenal mucosal damage between two treatments||0.34|-0.46|0.7591
72325873|NCT01822665|144175149|SUPERIORITY_OR_OTHER||LS mean difference|0.17||||0.4126|TWO_SIDED|95.0|-0.24|0.57||No multiple comparisons were carried out.|t-test, 2 sided|Period and treatment were included in the model as fixed effects, while subjects were a random effect.|Difference was first named treatment minus second named treatment, such that a positive difference favors the first named treatment.|Null hypothesis considered no significant difference in mean endoscopy score of duodenal mucosal damage between two treatments.||0.57|-0.24|0.4126
72325874|NCT01822665|144175149|SUPERIORITY_OR_OTHER||LS mean difference|0.03||||0.8903|TWO_SIDED|95.0|-0.39|0.45||No multiple comparisons were carried out.|t-test, 2 sided|Period and treatment were included in the model as fixed effects, while subjects were a random effect.|Difference was first named treatment minus second named treatment, such that a positive difference favors the first named treatment.|Null hypothesis considered no significant difference in mean endoscopy score of duodenal mucosal damage between two treatments||0.45|-0.39|0.8903
72609423|NCT02741284|144747646|SUPERIORITY||Mean Difference (Net)|-1.5||||0.44|TWO_SIDED|95.0|-5.4|2.4|||t-test, 2 sided|||||2.4|-5.4|0.44
72325875|NCT01822665|144175149|SUPERIORITY_OR_OTHER||LS mean difference|0.26||||0.2227|TWO_SIDED|95.0|-0.16|0.67||No multiple comparisons were carried out.|t-test, 2 sided|Period and treatment were included in the model as fixed effects, while subjects were a random effect.|Difference was first named treatment minus second named treatment, such that a positive difference favors the first named treatment.|Null hypothesis considered no significant difference in mean endoscopy score of duodenal mucosal damage between two treatments||0.67|-0.16|0.2227
72609424|NCT02741284|144747647|SUPERIORITY||Mean Difference (Net)|-4.7||||0.06|TWO_SIDED|95.0|-9.6|0.1|||t-test, 2 sided|||||0.1|-9.6|0.06
72609425|NCT02741284|144747648|SUPERIORITY||Mean Difference (Net)|0.0||||0.99|TWO_SIDED|95.0|-1.0|1.0|||t-test, 2 sided|||||1.0|-1.0|0.99
72609426|NCT01516216|144747684|SUPERIORITY|||||||0.07|||||||Log Rank|||||||0.07
72609427|NCT01516216|144747685|SUPERIORITY|||||||0.43|||||||Log Rank|||||||0.43
72609428|NCT01516216|144747686|SUPERIORITY|||||||0.27|||||||Chi-squared|||||||0.27
72609429|NCT01516216|144747688|SUPERIORITY|||||||0.68|||||||Chi-squared|||||||0.68
72609430|NCT01516216|144747691|SUPERIORITY|||||||0.9801|||||||Chi-squared|||||||0.9801
72609431|NCT01516216|144747692|SUPERIORITY|||||||0.7444|||||||Chi-squared|||||||0.7444
72609432|NCT01603602|144747693|SUPERIORITY||Least Squares (LS) Mean Difference|-0.66|||<|0.001|TWO_SIDED|95.0|-0.938|-0.379||MMRM model with baseline MAS-B score as covariate; factors of age, principal muscle group, treatment, visit, treatment-by-visit interaction, study center and previous botulinum toxin exposure, stratified by age and principal muscle group categories.|Mixed Model Repeated Measures (MMRM)|||||-0.379|-0.938|<0.001
72609433|NCT01603602|144747693|SUPERIORITY||LS Mean Difference|-0.71|||<|0.001|TWO_SIDED|95.0|-0.992|-0.426||MMRM model with baseline MAS-B score as covariate; factors of age, principal muscle group, treatment, visit, treatment-by-visit interaction, study center and previous botulinum toxin exposure, stratified by age and principal muscle group categories.|MMRM|||||-0.426|-0.992|<0.001
72609434|NCT01603602|144747694|SUPERIORITY||LS Mean Difference|0.21||||0.155|TWO_SIDED|95.0|-0.082|0.511||MMRM model with baseline MAS-B score as covariate; factors of age, principal muscle group, treatment, visit, treatment-by-visit interaction, study center and previous botulinum toxin exposure, stratified by age and principal muscle group categories.|MMRM|||||0.511|-0.082|0.155
72417952|NCT00540124|144346197|SUPERIORITY_OR_OTHER|||||||0.595||95.0||||P-value for 12 Week Change Terminal Micturation Dribble. Change=Endpoint minus baseline. P-values for pairwise comparison of change difference based on Wilcoxon Rank Sum test.|Wilcoxon Rank Sum|||||||0.595
72417953|NCT00540124|144346197|SUPERIORITY_OR_OTHER|||||||0.704||95.0||||P-value for 12 Week Change Post Micturation Dribble. Change=Endpoint minus baseline. P-values for pairwise comparison of change difference based on Wilcoxon Rank Sum test.|Wilcoxon Rank Sum|||||||0.704
72417954|NCT00540124|144346197|SUPERIORITY_OR_OTHER|||||||0.439||95.0||||P-value for 12 Week Change Post Micturation Dribble. Change=Endpoint minus baseline. P-values for pairwise comparison of change difference based on Wilcoxon Rank Sum test.|Wilcoxon Rank Sum|||||||0.439
72417955|NCT00540124|144346198|SUPERIORITY_OR_OTHER|||||||0.838||95.0||||P-value for 12 Week Change Qmax. Change=Endpoint minus baseline. P-values are from an ANCOVA with effects for treatment, prior alpha blocker use (yes/no), and baseline value, and were not adjusted for multiple comparisons.|ANCOVA|||||||0.838
72417956|NCT00540124|144346198|SUPERIORITY_OR_OTHER|||||||0.831||95.0||||P-value for 12 Week Change Qmax. Change=Endpoint minus baseline. P-values are from an ANCOVA with effects for treatment, prior alpha blocker use (yes/no), and baseline value, and were not adjusted for multiple comparisons.|ANCOVA|||||||0.831
72417957|NCT00540124|144346198|SUPERIORITY_OR_OTHER|||||||0.696||95.0||||P-value for 12 Week Change Qmean. Change=Endpoint minus baseline. P-values are from an ANCOVA with effects for treatment, prior alpha blocker use (yes/no), and baseline value, and were not adjusted for multiple comparisons.|ANCOVA|||||||0.696
72417958|NCT00540124|144346198|SUPERIORITY_OR_OTHER|||||||0.257||95.0||||P-value for 12 Week Change Qmean. Change=Endpoint minus baseline. P-values are from an ANCOVA with effects for treatment, prior alpha blocker use (yes/no), and baseline value, and were not adjusted for multiple comparisons.|ANCOVA|||||||0.257
72417959|NCT00540124|144346199|SUPERIORITY_OR_OTHER|||||||0.709||95.0||||P-value for 12 Week Change. Change=Endpoint minus baseline. P-values are from an ANCOVA with effects for treatment, prior alpha blocker use (yes/no), and baseline value, and were not adjusted for multiple comparisons.|ANCOVA|||||||0.709
72417960|NCT00540124|144346199|SUPERIORITY_OR_OTHER|||||||0.494||95.0||||P-value for 12 Week Change. Change=Endpoint minus baseline. P-values are from an ANCOVA with effects for treatment, prior alpha blocker use (yes/no), and baseline value, and were not adjusted for multiple comparisons.|ANCOVA|||||||0.494
72417961|NCT01163097|144346205|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence of the treatments was assessed using the 90% confidence interval (CI) of the geometric mean ratio for Ki67. The lower bound of the CI needed to be greater than 0.70 and the upper bound needed to be below 1.43 for the treatments to be considered equivalent.|Geometric mean ratio|0.863|||||TWO_SIDED|90.0|0.759|0.982|||ANCOVA|ANCOVA was used to estimate the treatment effect and the Schuirmann's two one-sided test was used to test for statistical equivalence.||H0: mean ratio\<0.7 or mean ratio\>1.43; H1: 0.7\< mean ratio \<1.43 Sample size calculation assumed change in Ki67 expression following palifermin administration would not be affected by co-administration of heparin. With n=26 (13 + 13), an approx. 80% probability that the 90% CI of the ratio of geometric means of Ki67 for palifermin when co-administered with heparin compared to palifermin alone would fall in the interval (0.7, 1.43). This assumed a Coefficient of Variation (CV) for Ki67 of 31%.||0.982|0.759|
72417962|NCT01163097|144346207|SUPERIORITY_OR_OTHER||Geometric mean|0.737|||||TWO_SIDED|95.0|0.614|0.885|||ANCOVA|ANCOVA (with dependent variable:natural log of the ratio to baseline, independent variable:treatment, covariate:natural log of the baseline value)||80% power achieved for detecting a 20% increase (or 17% reduction) when Treatment A was compared to Treatment B; assuming that the coefficient of variation of amylase would be 14% (as observed in other study)||0.885|0.614|
72417963|NCT01163097|144346208|SUPERIORITY_OR_OTHER||Geometric mean|0.373|||||TWO_SIDED|95.0|0.216|0.645|||ANCOVA|ANCOVA (with dependent variable:natural log of the ratio to baseline, independent variable:treatment, covariate:natural log of the baseline value)||80% power achieved for detecting a 70% increase (or 41% reduction) when Treatment A was compared to Treatment B; assuming that the coefficient of variation of lipase would be 49% (as observed in other study)||0.645|0.216|
72609435|NCT01603602|144747694|SUPERIORITY||LS Mean Difference|0.22||||0.147|TWO_SIDED|95.0|-0.079|0.523||MMRM model with baseline MAS-B score as covariate; factors of age, principal muscle group, treatment, visit, treatment-by-visit interaction, study center and previous botulinum toxin exposure, stratified by age and principal muscle group categories.|MMRM|||||0.523|-0.079|0.147
72609436|NCT01603602|144747695|SUPERIORITY||LS Mean Difference|-0.39||||0.111|TWO_SIDED|95.0|-0.861|0.091||ANCOVA model including baseline MAS-B score of finger flexor muscle group as a covariate and factors of age group, treatment group, study center, and previous botulinum toxin exposure where age group is represented by stratification categories.|ANCOVA|||||0.091|-0.861|0.111
72417964|NCT01163097|144346209|SUPERIORITY_OR_OTHER||Geometric mean|0.972|||||TWO_SIDED|95.0|0.768|1.231|||ANCOVA|ANCOVA (with dependent variable:natural log of the ratio to baseline, independent variable:treatment, covariate:natural log of the baseline value)||80% power achieved for detecting a 140% increase with 13 and 6 subjects (respectively) when Treatment B was compared to Treatment C; assuming that the coefficient of variation of the protein/creatinine ratio would be 67% (Ginsberg et al 1983)||1.231|0.768|
72417965|NCT01163097|144346210|SUPERIORITY_OR_OTHER||||||<|0.0001||90.0|||||ANOVA|||||||<0.0001
72417966|NCT01163097|144346211|SUPERIORITY_OR_OTHER||||||<|0.0001||90.0|||||ANOVA|||||||<0.0001
72417967|NCT01163097|144346212|SUPERIORITY_OR_OTHER||||||<|0.0001||90.0|||||ANOVA|||||||<0.0001
72417968|NCT01163097|144346213|SUPERIORITY_OR_OTHER||||||<|0.0001||90.0|||||ANOVA|||||||<0.0001
72417969|NCT01163097|144346214|SUPERIORITY_OR_OTHER|||||||0.4123||90.0|||||ANOVA|||||||0.4123
72417970|NCT01163097|144346215|SUPERIORITY_OR_OTHER|||||||0.9944||90.0|||||ANOVA|||||||0.9944
72417971|NCT01163097|144346216|SUPERIORITY_OR_OTHER||||||<|0.0001||90.0|||||ANOVA|||||||<0.0001
72417972|NCT01163097|144346217|SUPERIORITY_OR_OTHER||||||<|0.0001||90.0|||||ANOVA|||||||<0.0001
72417973|NCT01569438|144346232|OTHER||Mean Difference|-0.7||||0.0734|TWO_SIDED|90.0|-1.6|0.2||one-sided|Mixed Model with Repeated Measures|||MMRM approach was used to model the change from baseline as a function of treatment, week, treatment by week interaction, baseline score, and baseline score by week interaction.||0.2|-1.6|0.0734
72609437|NCT01603602|144747695|SUPERIORITY||LS Mean Difference|-0.44||||0.078|TWO_SIDED|95.0|-0.933|0.051||ANCOVA model including baseline MAS-B score of finger flexor muscle group as a covariate and factors of age group, treatment group, study center, and previous botulinum toxin exposure where age group is represented by stratification categories.|ANCOVA|||||0.051|-0.933|0.078
72609438|NCT01603602|144747696|SUPERIORITY||LS Mean Difference|-0.1||||0.636|TWO_SIDED|95.0|-0.498|0.305||ANCOVA model including baseline MAS-B score as a covariate; factors of age, principal muscle group, treatment, study center and previous botulinum toxin exposure where age and principal muscle group were represented by stratification categories.|ANCOVA|||Week 8, Active Goal||0.305|-0.498|0.636
72609439|NCT01603602|144747696|SUPERIORITY||LS Mean Difference|-0.09||||0.658|TWO_SIDED|95.0|-0.502|0.318||ANCOVA model including baseline MAS-B score as a covariate; factors of age, principal muscle group, treatment, study center and previous botulinum toxin exposure where age and principal muscle group were represented by stratification categories.|ANCOVA|||Week 8, Active Goal||0.318|-0.502|0.658
72609440|NCT01603602|144747696|SUPERIORITY||LS Mean Difference|0.24||||0.243|TWO_SIDED|95.0|-0.162|0.635||ANCOVA model including baseline MAS-B score as a covariate; factors of age, principal muscle group, treatment, study center and previous botulinum toxin exposure where age and principal muscle group were represented by stratification categories.|ANCOVA|||Week 8, Passive Goal||0.635|-0.162|0.243
72609441|NCT01603602|144747696|SUPERIORITY||LS Mean Difference|0.17||||0.412|TWO_SIDED|95.0|-0.237|0.576||ANCOVA model including baseline MAS-B score as a covariate; factors of age, principal muscle group, treatment, study center and previous botulinum toxin exposure where age and principal muscle group were represented by stratification categories.|ANCOVA|||Week 8, Passive Goal||0.576|-0.237|0.412
72609442|NCT01603602|144747696|SUPERIORITY||LS Mean Difference|-0.02||||0.904|TWO_SIDED|95.0|-0.408|0.361||ANCOVA model including baseline MAS-B score as a covariate; factors of age, principal muscle group, treatment, study center and previous botulinum toxin exposure where age and principal muscle group were represented by stratification categories.|ANCOVA|||Week 12, Active Goal||0.361|-0.408|0.904
72609443|NCT01603602|144747696|SUPERIORITY||LS Mean Difference|-0.25||||0.2|TWO_SIDED|95.0|-0.641|0.135||ANCOVA model including baseline MAS-B score as a covariate; factors of age, principal muscle group, treatment, study center and previous botulinum toxin exposure where age and principal muscle group were represented by stratification categories.|ANCOVA|||Week 12, Active Goal||0.135|-0.641|0.200
72609444|NCT01603602|144747696|SUPERIORITY||LS Mean Difference|0.59||||0.003|TWO_SIDED|95.0|0.21|0.978||ANCOVA model including baseline MAS-B score as a covariate; factors of age, principal muscle group, treatment, study center and previous botulinum toxin exposure where age and principal muscle group were represented by stratification categories.|ANCOVA|||Week 12, Passive Goal||0.978|0.210|0.003
72609445|NCT01603602|144747696|SUPERIORITY||LS Mean Difference|0.19||||0.327|TWO_SIDED|95.0|-0.194|0.58||ANCOVA model including baseline MAS-B score as a covariate; factors of age, principal muscle group, treatment, study center and previous botulinum toxin exposure where age and principal muscle group were represented by stratification categories.|ANCOVA|||Week 12, Passive Goal||0.580|-0.194|0.327
72609446|NCT01603602|144747697|SUPERIORITY||LS Mean Difference|12.1||||0.117|TWO_SIDED|95.0|-3.089|27.293||ANCOVA model including baseline MTS as a covariate and factors of age group, treatment group, study center and botulinum toxin exposure where age group is represented by stratification categories.|ANCOVA|||Change from Baseline to Week 2, Elbow||27.293|-3.089|0.117
72609447|NCT01603602|144747697|SUPERIORITY||LS Mean Difference|8.41||||0.273|TWO_SIDED|95.0|-6.717|23.527||ANCOVA model including baseline MTS as a covariate and factors of age group, treatment group, study center and botulinum toxin exposure where age group is represented by stratification categories.|ANCOVA|||Change from Baseline to Week 2, Elbow||23.527|-6.717|0.273
72609448|NCT01603602|144747697|SUPERIORITY||LS Mean Difference|14.71||||0.015|TWO_SIDED|95.0|2.958|26.458||ANCOVA model including baseline MTS as a covariate and factors of age group, treatment group, study center and botulinum toxin exposure where age group is represented by stratification categories.|ANCOVA|||Change from Baseline to Week 4, Elbow||26.458|2.958|0.015
72609449|NCT01603602|144747697|SUPERIORITY||LS Mean Difference|11.85||||0.046|TWO_SIDED|95.0|0.203|23.504||ANCOVA model including baseline MTS as a covariate and factors of age group, treatment group, study center and botulinum toxin exposure where age group is represented by stratification categories.|ANCOVA|||Change from Baseline to Week 4, Elbow||23.504|0.203|0.046
72417974|NCT01569438|144346233|OTHER||Mean Difference|-1.0||||0.2726|TWO_SIDED|90.0|-3.9|1.8||one-sided|Mixed Model With Repeated Measures|||MMRM approach was used to model the change from baseline as a function of treatment, week, treatment by week interaction, baseline score, and baseline score by week interaction.||1.8|-3.9|0.2726
72609450|NCT01603602|144747697|SUPERIORITY||LS Mean Difference|20.97|||<|0.001|TWO_SIDED|95.0|8.801|33.137||ANCOVA model including baseline MTS as a covariate and factors of age group, treatment group, study center and botulinum toxin exposure where age group is represented by stratification categories.|ANCOVA|||Change from Baseline to Week 6, Elbow||33.137|8.801|<0.001
72609451|NCT01603602|144747697|SUPERIORITY||LS Mean Difference|11.35||||0.064|TWO_SIDED|95.0|-0.662|23.362||ANCOVA model including baseline MTS as a covariate and factors of age group, treatment group, study center and botulinum toxin exposure where age group is represented by stratification categories.|ANCOVA|||Change from Baseline to Week 6, Elbow||23.362|-0.662|0.064
72609452|NCT01603602|144747697|SUPERIORITY||LS Mean Difference|15.25||||0.013|TWO_SIDED|95.0|3.317|27.178||ANCOVA model including baseline MTS as a covariate and factors of age group, treatment group, study center and botulinum toxin exposure where age group is represented by stratification categories.|ANCOVA|||Change from Baseline to Week 8, Elbow||27.178|3.317|0.013
72609453|NCT01603602|144747697|SUPERIORITY||LS Mean Difference|7.22||||0.225|TWO_SIDED|95.0|-4.488|18.934||ANCOVA model including baseline MTS as a covariate and factors of age group, treatment group, study center and botulinum toxin exposure where age group is represented by stratification categories.|ANCOVA|||Change from Baseline to Week 8, Elbow||18.934|-4.488|0.225
72609454|NCT01603602|144747697|SUPERIORITY||LS Mean Difference|4.5||||0.409|TWO_SIDED|95.0|-6.239|15.236||ANCOVA model including baseline MTS as a covariate and factors of age group, treatment group, study center and botulinum toxin exposure where age group is represented by stratification categories.|ANCOVA|||Change from Baseline to Week 12, Elbow||15.236|-6.239|0.409
72609455|NCT01603602|144747697|SUPERIORITY||LS Mean Difference|3.86||||0.47|TWO_SIDED|95.0|-6.69|14.419||ANCOVA model including baseline MTS as a covariate and factors of age group, treatment group, study center and botulinum toxin exposure where age group is represented by stratification categories.|ANCOVA|||Change from Baseline to Week 12, Elbow||14.419|-6.690|0.470
72609456|NCT01603602|144747697|SUPERIORITY||LS Mean Difference|-6.13||||0.263|TWO_SIDED|95.0|-16.962|4.706||ANCOVA model including baseline MTS as a covariate and factors of age group, treatment group, study center and botulinum toxin exposure where age group is represented by stratification categories.|ANCOVA|||Change from Baseline to Week 2, Wrist||4.706|-16.962|0.263
72609457|NCT01603602|144747697|SUPERIORITY||LS Mean Difference|-14.6||||0.012|TWO_SIDED|95.0|-25.846|-3.36||ANCOVA model including baseline MTS as a covariate and factors of age group, treatment group, study center and botulinum toxin exposure where age group is represented by stratification categories.|ANCOVA|||Change from Baseline to Week 2, Wrist||-3.360|-25.846|0.012
72609458|NCT01603602|144747697|SUPERIORITY||LS Mean Difference|-10.64||||0.098|TWO_SIDED|95.0|-23.277|1.996||ANCOVA model including baseline MTS as a covariate and factors of age group, treatment group, study center and botulinum toxin exposure where age group is represented by stratification categories.|ANCOVA|||Change from Baseline to Week 4, Wrist||1.996|-23.277|0.098
72609459|NCT01603602|144747697|SUPERIORITY||LS Mean Difference|-13.1||||0.051|TWO_SIDED|95.0|-26.26|0.068||ANCOVA model including baseline MTS as a covariate and factors of age group, treatment group, study center and botulinum toxin exposure where age group is represented by stratification categories.|ANCOVA|||Change from Baseline to Week 4, Wrist||0.068|-26.260|0.051
72609460|NCT01603602|144747697|SUPERIORITY||LS Mean Difference|-17.11||||0.01|TWO_SIDED|95.0|-30.031|-4.189||ANCOVA model including baseline MTS as a covariate and factors of age group, treatment group, study center and botulinum toxin exposure where age group is represented by stratification categories.|ANCOVA|||Change from Baseline to Week 6, Wrist||-4.189|-30.031|0.010
72609461|NCT01603602|144747697|SUPERIORITY||LS Mean Difference|-11.25||||0.098|TWO_SIDED|95.0|-24.622|2.131||ANCOVA model including baseline MTS as a covariate and factors of age group, treatment group, study center and botulinum toxin exposure where age group is represented by stratification categories.|ANCOVA|||Change from Baseline to Week 6, Wrist||2.131|-24.622|0.098
72609462|NCT01603602|144747697|SUPERIORITY||LS Mean Difference|-17.71||||0.005|TWO_SIDED|95.0|-29.888|-5.537||ANCOVA model including baseline MTS as a covariate and factors of age group, treatment group, study center and botulinum toxin exposure where age group is represented by stratification categories.|ANCOVA|||Change from Baseline to Week 8, Wrist||-5.537|-29.888|0.005
72609463|NCT01603602|144747697|SUPERIORITY||LS Mean Difference|-15.74||||0.015|TWO_SIDED|95.0|-28.293|-3.194||ANCOVA model including baseline MTS as a covariate and factors of age group, treatment group, study center and botulinum toxin exposure where age group is represented by stratification categories.|ANCOVA|||Change from Baseline to Week 8, Wrist||-3.194|-28.293|0.015
72609464|NCT01603602|144747697|SUPERIORITY||LS Mean Difference|-15.25||||0.02|TWO_SIDED|95.0|-28.01|-2.492||ANCOVA model including baseline MTS as a covariate and factors of age group, treatment group, study center and botulinum toxin exposure where age group is represented by stratification categories.|ANCOVA|||Change from Baseline to Week 12, Wrist||-2.492|-28.010|0.020
72609465|NCT01603602|144747697|SUPERIORITY||LS Mean Difference|-13.52||||0.046|TWO_SIDED|95.0|-26.797|-0.243||ANCOVA model including baseline MTS as a covariate and factors of age group, treatment group, study center and botulinum toxin exposure where age group is represented by stratification categories.|ANCOVA|||Change from Baseline to Week 12, Wrist||-0.243|-26.797|0.046
72609466|NCT01450813|144747702|NON_INFERIORITY_OR_EQUIVALENCE|Sample size needed for a one-way ANOVA test with an alpha of 0.05 and power of 0.8 to rule out the null hypothesis that neuromuscular blocking drugs have no effect on CVI with 95% confidence was a total of 64 or 16 per Group.|||||<|0.05||||||Comparisons of the means were accomplished via student's t-test with Bonferroni correction for multiple comparisons.|ANOVA|||Null hypothesis that neuromuscular blocking drugs have no effect on CVI with 95% confidence.||||< 0.05
72609467|NCT01935089|144747704|OTHER|"Hypothesis: 20 weeks of treatment (baseline week 3 to endpoint week 24) will result in a change in the levels of integrated HIV-1 DNA (copies/CD4 T cell Variable name: intDNA).~Test if the mean difference (IntDNA wk24 - IntDNAwk3) is significantly different from zero (i.e. no change) Null hypothesis: Mean (IntDNA wk24 - IntDNAwk3) = 0; reject if p\<0.05"||||||0.0797||||||significant if \<0.05|signed rank test|||||||0.0797
72609468|NCT00723229|144747744|SUPERIORITY_OR_OTHER||Incidence Risk Ratio|0.2|||<|0.001|TWO_SIDED|95.0|0.17|0.25|||Regression, poisson|Adjusted for period effects.||The trial had 80% power to detect a 35% reduction in genital shedding rates for acyclovir 400 mg twice daily.||0.25|0.17|<0.001
72609469|NCT00723229|144747744|SUPERIORITY|Adjusted for period effects.|Risk Ratio (RR)|0.05|||<|0.001|TWO_SIDED|95.0|0.03|0.08|||Regression, Poisson|||Among HIV seronegative individuals.||0.08|0.03|<0.001
72609470|NCT00723229|144747744|SUPERIORITY|Adjusted for period effects.|Risk Ratio (RR)|0.5|||<|0.001|TWO_SIDED|95.0|0.4|0.6|||Regression, Poisson|||Among HIV seropositive individuals.||0.6|0.4|<0.001
72609471|NCT03073486|144747758|OTHER|||||||0.2301|||||||ANCOVA|Ranked ANCOVA, Markov Chain Monte Carlo (MCMC) Multiple Imputation||||||0.2301
72609472|NCT03073486|144747759|OTHER|||||||0.6888|||||||ANCOVA|Ranked ANCOVA, Markov Chain Monte Carlo (MCMC) Multiple Imputation||||||0.6888
72609473|NCT03073486|144747760|OTHER|||||||0.1361|||||||Regression, Logistic|Logistic Regression (Firth's Penalized Likelihood), MCMC Multiple Imputation||||||0.1361
72609474|NCT01079780|144747767|SUPERIORITY||Hazard Ratio (HR)|0.75|||||TWO_SIDED|||||||||||||
72609475|NCT01079780|144747768|SUPERIORITY|||||||0.27|||||||Chi-squared|||||||0.27
72609476|NCT01079780|144747770|SUPERIORITY||Hazard Ratio (HR)|0.86||||0.55|TWO_SIDED||||||Log Rank|||||||0.55
72609477|NCT03435055|144747771|SUPERIORITY|||||||0.001|||||||t-test, 2 sided|||Paired t-test were conducted on subject specific beta maps to identify changes in connectivity associated with nitrous oxide in SPM12. Hypothesis was that the results would be deemed significant at false discovery rate (FDR) cluster level corrected p \< 0.05 derived from a voxel-wise uncorrected p-value \< 0.001.||||0.001
72609478|NCT03435055|144747772|SUPERIORITY|||||||0.006|||||||t-test, 2 sided|||Paired t-test were conducted on subject specific beta maps to identify changes in connectivity associated with nitrous oxide in SPM12. Hypothesis was that results would be deemed significant at false discovery rate (FDR) cluster level corrected p \< 0.05 derived from a voxel-wise uncorrected p-value \< 0.001.||||0.006
72609479|NCT03435055|144747773|SUPERIORITY||||||<|0.01|||||||t-test, 2 sided|||Paired-t tests were conducted to determine whether changes in stimulus intensity: post stimulus at baseline and under subanesthetic dose of nitrous oxide. Statistical tests were completed in SPSS 26 and determined by p \< 0.05.||||<0.01
72609480|NCT03435055|144747774|OTHER|Paired T-test comparing baseline to nitrous||||||0.0622|||||||Paired t-test|||Delta||||0.0622
72609481|NCT03435055|144747774|OTHER|Paired T-test comparing baseline to nitrous||||||0.0292|||||||Paired t-test|||Theta||||0.0292
72609482|NCT03435055|144747774|OTHER|Paired T-test comparing baseline to nitrous||||||0.5905|||||||Paired t-test|||Alpha comparison||||0.5905
72609483|NCT01668797|144747804|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Log Rank|The log-rank test was based on time to exacerbation of psychotic symptoms/impending relapse.||The total number of exacerbation of psychotic symptoms/impending relapse was estimated using a 1:1 (brexpiprazole:placebo) randomization ratio.||||<0.0001
72609484|NCT01668797|144747805|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Chi-squared|||The percentage of participants with impending relapse in treatment groups (Brexpiprazole and placebo) in final analysis for participants meeting at least one of the criteria.||||<0.0001
72609485|NCT01668797|144747806|SUPERIORITY_OR_OTHER|||||||0.2296|||||||Chi-squared|||Statistical analysis at Week 6.||||0.2296
72609486|NCT01668797|144747806|SUPERIORITY_OR_OTHER|||||||0.2051|||||||Chi-squared|||Statistical analysis at Week 12.||||0.2051
72609487|NCT01668797|144747806|SUPERIORITY_OR_OTHER|||||||0.7354|||||||Chi-squared|||Statistical analysis at Week 24.||||0.7354
72609488|NCT01668797|144747806|SUPERIORITY_OR_OTHER|||||||0.1977|||||||Chi-squared|||Statistical analysis at Week 36.||||0.1977
72609489|NCT01668797|144747806|SUPERIORITY_OR_OTHER|||||||0.8734|||||||Chi-squared|||Statistical analysis at Week 52.||||0.8734
72609490|NCT01668797|144747806|SUPERIORITY_OR_OTHER|||||||0.0007|||||||Chi-squared|||Statistical analysis at Last Visit.||||0.0007
72609491|NCT01668797|144747807|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.3||||0.0664|TWO_SIDED|95.0|-6.82|0.23|||Mixed Models Analysis|||Statistical analysis of treatment comparisons at Week 6.||0.23|-6.82|0.0664
72609492|NCT01668797|144747807|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.31||||0.0301|TWO_SIDED|95.0|-10.1|-0.52|||Mixed Models Analysis|||Statistical analysis of treatment comparisons at Week 12.||-0.52|-10.1|0.0301
72609493|NCT01668797|144747807|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.77||||0.0226|TWO_SIDED|95.0|-8.86|-0.68|||Mixed Models Analysis|||Statistical analysis of treatment comparisons at Week 24.||-0.68|-8.86|0.0226
72609494|NCT01668797|144747807|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.03||||0.0086|TWO_SIDED|95.0|-10.5|-1.59|||Mixed Models Analysis|||Statistical analysis of treatment comparisons at Week 36.||-1.59|-10.5|0.0086
72609495|NCT01668797|144747807|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.31||||0.28|TWO_SIDED|95.0|-18.1|5.46|||Mixed Models Analysis|||Statistical analysis of treatment comparisons at Week 52.||5.46|-18.1|0.2800
72609496|NCT01668797|144747807|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.42||||0.0011|TWO_SIDED|95.0|-7.01|-1.82|||Mixed Models Analysis|||Statistical analysis at across visits||-1.82|-7.01|0.0011
72609497|NCT01668797|144747808|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.04||||0.0683|TWO_SIDED|95.0|-6.31|0.23|||ANCOVA|||Statistical analysis at Week 6.||0.23|-6.31|0.0683
72609498|NCT01668797|144747808|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.05||||0.0174|TWO_SIDED|95.0|-9.2|-0.9|||ANCOVA|||Statistical analysis at Week 12.||-0.90|-9.20|0.0174
72609499|NCT01668797|144747808|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.59||||0.0008|TWO_SIDED|95.0|-12.0|-3.18|||ANCOVA|||Statistical analysis at Week 24.||-3.18|-12.0|0.0008
72609500|NCT01668797|144747808|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.02||||0.0005|TWO_SIDED|95.0|-12.4|-3.59|||ANCOVA|||Statistical analysis at Week 36.||-3.59|-12.4|0.0005
72609501|NCT01668797|144747808|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.95||||0.0007|TWO_SIDED|95.0|-12.5|-3.41|||ANCOVA|||Statistical analysis at Week 52.||-3.41|-12.5|0.0007
72609502|NCT01668797|144747809|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.11||||0.0507|TWO_SIDED|95.0|-2.23|0.0|||Mixed Models Analysis|||Statistical analysis at Week 6.||0.00|-2.23|0.0507
72609503|NCT01668797|144747809|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.87||||0.008|TWO_SIDED|95.0|-3.24|-0.5|||Mixed Models Analysis|||Statistical analysis at Week 12.||-0.50|-3.24|0.0080
72609504|NCT01668797|144747809|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.56||||0.0215|TWO_SIDED|95.0|-2.89|-0.24|||Mixed Models Analysis|||Statistical analysis at Week 24.||-0.24|-2.89|0.0215
72609505|NCT01668797|144747809|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.88||||0.0053|TWO_SIDED|95.0|-3.19|-0.58|||Mixed Models Analysis|||Statistical analysis at Week 36.||-0.58|-3.19|0.0053
72609506|NCT01668797|144747809|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.71||||0.339|TWO_SIDED|95.0|-5.2|-0.22|||Mixed Models Analysis|||Statistical analysis at Week 52.||-0.22|-5.20|0.339
72417975|NCT01569438|144346234|OTHER||Mean Difference|-0.3||||0.3603|TWO_SIDED|90.0|-1.7|1.1||one-sided|ANCOVA|||The one-way ANCOVA model was used to calculate change from baseline as a function of treatment and baseline score.||1.1|-1.7|0.3603
72417976|NCT01569438|144346235|OTHER||Mean Difference|-1.5||||0.1183|TWO_SIDED|90.0|-3.5|0.6||one-sided|ANCOVA|||The one-way ANCOVA model was used to calculate change from baseline as a function of treatment and baseline score.||0.6|-3.5|0.1183
72417977|NCT00452387|144346242|SUPERIORITY_OR_OTHER|||||||0.55||95.0|||||Fisher Exact|||The test of association of PSA and imaging response tests the null hypothesis that the proportion of cases exhibiting PSA response is the same for patients with and without a favorable imaging response. A 2x2 table was constructed based on the number of the patients in imaging response (favorable and unfavorable) and PSA response (\>50% reduction and \<=50% reduction). The Fisher's exact test was used to test this hypothesis.||||0.55
72417978|NCT00579280|144346253|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<.05
72417979|NCT00579280|144346254|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<0.05
72417980|NCT00579280|144346255|SUPERIORITY||||||<|0.05|||||||ANCOVA|||||||<0.05
72417981|NCT00579280|144346256|SUPERIORITY||||||<|0.05|||||||ANCOVA|||||||<.05
72609507|NCT01668797|144747809|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.6|||<|0.0001|TWO_SIDED|95.0|-2.32|-0.88|||Mixed Models Analysis|||Statistical analysis at across visits.||-0.88|-2.32|< 0.0001
72417982|NCT00579280|144346257|SUPERIORITY||||||<|0.05|||||||ANCOVA|||||||<0.05
72609508|NCT01668797|144747810|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.94||||0.1093|TWO_SIDED|95.0|-2.1|0.21|||ANCOVA|||Statistical analysis at Week 6.||0.21|-2.10|0.1093
72417983|NCT00579280|144346258|SUPERIORITY||||||<|0.05|||||||ANCOVA|||||||<0.05
72417984|NCT00579280|144346259|SUPERIORITY||||||<|0.05|||||||Chi-squared|Differences in response (70% or greater improvement) and remission (50% or greater improvement) rates between the groups.||||||<0.05
72417985|NCT00579280|144346260|SUPERIORITY||||||<|0.05|||||||ANCOVA|||||||<0.05
72609509|NCT01668797|144747810|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.86||||0.0089|TWO_SIDED|95.0|-3.25|-0.47|||ANOVA|||Statistical analysis at Week 12.||-0.47|-3.25|0.0089
72609510|NCT01668797|144747810|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.74||||0.0005|TWO_SIDED|95.0|-4.26|-1.22|||ANCOVA|||Statistical analysis at Week 24.||-1.22|-4.26|0.0005
72609511|NCT01668797|144747810|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.94||||0.0001|TWO_SIDED|95.0|-4.43|-1.44|||ANCOVA|||Statistical analysis at Week 36.||-1.44|-4.43|0.0001
72417986|NCT00579280|144346261|SUPERIORITY||||||<|0.05|||||||ANCOVA|||||||<0.05
72417987|NCT00579280|144346262|SUPERIORITY||||||<|0.05|||||||ANCOVA|||||||<0.05
72417988|NCT00579280|144346263|SUPERIORITY||||||<|0.05|||||||ANCOVA|||||||<0.05
72417989|NCT01693068|144346264|OTHER|A log-rank test stratified by baseline Eastern Cooperative Oncology Group performance status (ECOG PS) (using the interactive voice response system \[IVRS\] value) will tested the null hypothesis of no difference between the Pimasertib (first line) and the Dacarbazine treatment groups at the 5% level.|Hazard Ratio (HR)|0.59||||0.0022|TWO_SIDED|95.0|0.42|0.83|||Stratified Log Rank Test||The Hazard Ratio is obtained from the Cox Proportional Hazards model based on dacarbazine and pimasertib only stratified by baseline ECOG Performance Status.|||0.83|0.42|0.0022
72417990|NCT02510144|144346275|SUPERIORITY|||||||0.68|||||||t-test, 2 sided|||Negative cultures were compared on the treated side vs the non-treated side||||0.68
72417991|NCT02510144|144346275|SUPERIORITY||||||<|0.01|||||||t-test, 2 sided|||Negative cultures were compared on the treated side versus the non-treated side||||<0.01
72417992|NCT00977665|144346285|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.603||||0.6984|TWO_SIDED|95.0|-3.677|2.47||A priori threshold for statistical significance is 0.05.|repeated measures model|Fixed effects: categorical week in trial by treatment interaction, center, and baseline UMSARS score.||||2.470|-3.677|0.6984
72417993|NCT00977665|144346294|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.189|||||TWO_SIDED|95.0|0.646|2.186||||||||2.186|0.646|
72421660|NCT02332590|144354480|SUPERIORITY||LS Mean Difference|1.768||||0.0689|TWO_SIDED|95.0|-0.137|3.674||Threshold for significance at 0.05 level.|Mixed Models Analysis||Sarilumab 200 mg vs. Adalimumab 40 mg|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using MMRM approach with treatment, region, visits, and treatment-by-visit interaction as fixed effects and baseline FACIT-F score as a continuous covariate.||3.674|-0.137|0.0689
72421661|NCT05690776|144354551|SUPERIORITY||Mean Difference (Final Values)|12.1|STANDARD_DEVIATION|10.0|<|0.0001|TWO_SIDED|95.0|9.2|15.0|||paired t-test|||||15.0|9.2|<0.0001
72417994|NCT01212770|144346322|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|22.3|||<|0.0001|TWO_SIDED|95.0|13.0|31.6|||Cochran-Mantel-Haenszel|Adjusted for baseline disease modifying antirheumatic drug (DMARD) use and and ≥ 3% body surface area (BSA) psoriasis involvement at baseline.|Adjusted difference is the weighted average of the treatment differences across 4 strata of baseline DMARD use by ≥ 3% BSA psoriasis involvement at baseline with the CMH weights. The 95% CI is based on a normal approximation to the weighted average.|The percentage of participants with an ACR20 response was compared using a Cochran-Mantel- Haenszel (CMH) test. The Hochberg procedure was used to maintain the Type 1 error at the 0.05 significance level. The results were considered statistically significant if both the 30 mg apremilast dose versus placebo comparison and the 20 mg versus placebo comparison were statistically significant at the 0.05 significance level, or one of the comparisons was statistically significant at the 0.025 level.||31.6|13.0|<0.0001
72417995|NCT01212770|144346322|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|9.8||||0.0295|TWO_SIDED|95.0|1.1|18.6|||Cochran-Mantel-Haenszel|2-sided p-value based on the Cochran-Mantel-Haenszel test adjusting for baseline DMARD use and ≥ 3% BSA psoriasis involvement at baseline.|Adjusted difference is the weighted average of the treatment differences across 4 strata of baseline DMARD use by ≥ 3% BSA psoriasis involvement at baseline with the CMH weights. The 95% CI is based on a normal approximation to the weighted average.|In order to maintain the Type 1 error at the 0.05 significance level, the Hochberg procedure was to be used. The results of the endpoint were to be considered statistically significant if both the 30 mg apremilast dose versus placebo comparison and the 20 mg versus placebo comparison were statistically significant at the 0.05 significance level, or one of the comparisons was statistically significant at the 0.025 level.||18.6|1.1|0.0295
72417996|NCT01212770|144346323|SUPERIORITY||LS Mean Difference|-0.127||||0.0073|TWO_SIDED|95.0|-0.22|-0.034|||ANCOVA|Based on an ANCOVA model with treatment group, baseline DMARD use and ≥ 3% BSA psoriasis involvement as factors and the baseline value as a covariate.||Pairwise comparisons (30 mg vs placebo and 20 mg vs placebo) were conducted conditional on the primary endpoint results. If the primary endpoint was statistically significant for both apremilast dose groups, pairwise comparisons for the HAQ-DI were to be evaluated at the 0.05 level using the Hochberg procedure. If only one apremilast dose was statistically significant, then only the comparison between that apremilast dose and placebo was conducted for the HAQ-DI score, at the 0.025 level.||-0.034|-0.220|0.0073
72417997|NCT01212770|144346323|SUPERIORITY||LS Mean Difference|-0.066||||0.1619|TWO_SIDED|95.0|-0.158|0.027|||ANCOVA|Based on an ANCOVA model with treatment group, baseline DMARD use and ≥ 3% BSA psoriasis involvement as factors and the baseline value as a covariate.||Pairwise comparisons (30 mg vs placebo and 20 mg vs placebo) were conducted conditional on the primary endpoint results. If the primary endpoint was statistically significant for both apremilast dose groups, pairwise comparisons for the HAQ-DI were to be evaluated at the 0.05 level using the Hochberg procedure. If only one apremilast dose was statistically significant, then only the comparison between that apremilast dose and placebo was conducted for the HAQ-DI score, at the 0.025 level.||0.027|-0.158|0.1619
72417998|NCT01212770|144346324|SUPERIORITY||Adjusted Difference|15.5||||0.0007|TWO_SIDED|95.0|6.7|24.3||Secondary endpoints from the placebo-controlled period (Weeks 16 and 24) were analyzed in a hierarchical fashion to control the Type I error rate as described above.|Cochran-Mantel-Haenszel|Two-sided p-value based on the Cochran-Mantel-Haenszel (CMH) test adjusting for baseline DMARD use and ≥ 3% BSA psoriasis involvement at baseline.|Adjusted difference is the weighted average of the treatment differences across 4 strata of baseline DMARD use by ≥ 3% BSA psoriasis involvement at baseline with the CMH weights. The 95% CI is based on a normal approximation to the weighted average.|||24.3|6.7|0.0007
72417999|NCT01212770|144346324|SUPERIORITY||Adjusted Difference|11.1||||0.011|TWO_SIDED|95.0|2.7|19.5||Secondary endpoints from the placebo-controlled period (Weeks 16 and 24) were analyzed in a hierarchical fashion to control the Type I error rate as described above.|Cochran-Mantel-Haenszel|Two-sided p-value based on the Cochran-Mantel-Haenszel (CMH) test adjusting for baseline DMARD use and ≥ 3% BSA psoriasis involvement at baseline.|Adjusted difference is the weighted average of the treatment differences across 4 strata of baseline DMARD use by ≥ 3% BSA psoriasis involvement at baseline with the CMH weights. The 95% CI is based on a normal approximation to the weighted average.|||19.5|2.7|0.0110
72418000|NCT01212770|144346325|SUPERIORITY||LS Mean Difference|-0.139||||0.005|TWO_SIDED|95.0|-0.236|-0.042|||ANCOVA|Based on an ANCOVA model with treatment group, baseline DMARD use and ≥ 3% BSA psoriasis involvement as factors and the baseline value as a covariate.||Secondary endpoints from the placebo-controlled period (Weeks 16 and 24) were analyzed in a hierarchical fashion to control the Type I error rate as described above.||-0.042|-0.236|0.0050
72418001|NCT01212770|144346325|SUPERIORITY||LS Mean Difference|-0.084||||0.086|TWO_SIDED|95.0|-0.181|0.012|||ANCOVA|Based on an ANCOVA model with treatment group, baseline DMARD use and ≥ 3% BSA psoriasis involvement as factors and the baseline value as a covariate.||Secondary endpoints from the placebo-controlled period (Weeks 16 and 24) were analyzed in a hierarchical fashion to control the Type I error rate as described above.||0.012|-0.181|0.0860
72418002|NCT01212770|144346326|SUPERIORITY||LS Mean Difference|2.32||||0.0053|TWO_SIDED|95.0|0.69|3.95|||ANCOVA|Based on an ANCOVA model with treatment group, baseline DMARD use and ≥ 3% BSA psoriasis involvement as factors and the baseline value as a covariate.||Secondary endpoints from the placebo-controlled period (Weeks 16 and 24) were analyzed in a hierarchical fashion to control the Type I error rate as described above.||3.95|0.69|0.0053
72418003|NCT01212770|144346326|SUPERIORITY||LS mean Difference|1.15||||0.1658|TWO_SIDED|95.0|-0.48|2.77|||ANCOVA|Based on an ANCOVA model with treatment group, baseline DMARD use and ≥ 3% BSA psoriasis involvement as factors and the baseline value as a covariate.||Secondary endpoints from the placebo-controlled period (Weeks 16 and 24) were analyzed in a hierarchical fashion to control the Type I error rate as described above.||2.77|-0.48|0.1658
72418004|NCT01212770|144346327|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|25.4|||<|0.0001|TWO_SIDED|95.0|15.5|35.3|||Cochran-Mantel-Haenszel|Two-sided p-value based on the Cochran-Mantel-Haenszel (CMH) test adjusting for baseline DMARD use and ≥ 3% BSA psoriasis involvement at baseline.|Adjusted difference is the weighted average of the treatment differences across 4 strata of baseline DMARD use by ≥ 3% BSA psoriasis involvement at baseline with the CMH weights. The 95% CI is based on a normal approximation to the weighted average.|Secondary endpoints from the placebo-controlled period (Weeks 16 and 24) were analyzed in a hierarchical fashion to control the Type I error rate as described above.||35.3|15.5|<0.0001
72421662|NCT05690776|144354552|SUPERIORITY||Mean Difference (Final Values)|0.09|STANDARD_DEVIATION|0.133|<|0.0001|TWO_SIDED|95.0|0.053|0.128|||paired t-test|||||0.128|0.053|<0.0001
72421663|NCT05690776|144354554|SUPERIORITY||Mean Difference (Final Values)|20.7|STANDARD_DEVIATION|13.2|<|0.0001|TWO_SIDED|95.0|16.9|24.5|||paired t-test|||||24.5|16.9|<0.0001
72609512|NCT01668797|144747810|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.18|||<|0.0001|TWO_SIDED|95.0|-4.7|-1.66|||ANCOVA|||Statistical analysis at Week 52||-1.66|-4.70|<0.0001
72609513|NCT01668797|144747811|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.69||||0.165|TWO_SIDED|95.0|-1.66|0.29|||Mixed Models Analysis|||Statistical analysis at Week 6.||0.29|-1.66|0.1650
72609514|NCT01668797|144747811|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.78||||0.2001|TWO_SIDED|95.0|-1.97|0.42|||Mixed Models Analysis|||Statistical analysis at Week 12.||0.42|-1.97|0.2001
72609515|NCT01668797|144747811|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.95||||0.0939|TWO_SIDED|95.0|-2.07|0.16|||Mixed Models Analysis|||Statistical analysis at Week 24.||0.16|-2.07|0.0939
72609516|NCT01668797|144747811|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.05||||0.1396|TWO_SIDED|95.0|-2.44|0.35|||Mixed Models Analysis|||Statistical analysis at Week 36.||0.35|-2.44|0.1396
72609517|NCT01668797|144747811|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.43||||0.847|TWO_SIDED|95.0|-4.14|5.0|||Mixed Models Analysis|||Statistical analysis at Week 52.||5.00|-4.14|0.8470
72609518|NCT01668797|144747811|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.47||||0.2258|TWO_SIDED|95.0|-1.24|0.3|||Mixed Models Analysis|||Statistical analysis at across visits.||0.3|-1.24|0.2258
72609519|NCT01668797|144747812|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.76||||0.0981|TWO_SIDED|95.0|-1.65|0.14|||ANCOVA|||Statistical analysis at Week 6.||0.14|-1.65|0.0981
72609520|NCT01668797|144747812|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.22||||0.0264|TWO_SIDED|95.0|-2.3|-0.15|||ANCOVA|||Statistical analysis at Week 12.||-0.15|-2.30|0.0264
72609521|NCT01668797|144747812|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.55||||0.0078|TWO_SIDED|95.0|-2.69|-0.42|||ANCOVA|||Statistical analysis at Week 24.||-0.42|-2.69|0.0078
72609522|NCT01668797|144747812|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.57||||0.0101|TWO_SIDED|95.0|-2.77|-0.38|||ANCOVA|||Statistical analysis at Week 36.||-0.38|-2.77|0.0101
72609523|NCT01668797|144747812|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.24||||0.0516|TWO_SIDED|95.0|-2.5|0.01|||ANCOVA|||Statistical analysis at Week 52||0.01|-2.50|0.0516
72609524|NCT01668797|144747813|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.28||||0.0279|TWO_SIDED|95.0|-0.53|-0.03|||Mixed Models Analysis|||Statistical analysis at Week 6.||-0.03|-0.53|0.0279
72609525|NCT01668797|144747813|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.39||||0.0117|TWO_SIDED|95.0|-0.68|-0.09|||Mixed Models Analysis|||Statistical analysis at Week 12.||-0.09|-0.68|0.0117
72609526|NCT01668797|144747813|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.37||||0.0105|TWO_SIDED|95.0|-0.64|-0.09|||Mixed Models Analysis|||Statistical analysis at Week 24.||-0.09|-0.64|0.0105
72609527|NCT01668797|144747813|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.56||||0.0007|TWO_SIDED|95.0|-0.87|-0.25|||Mixed Models Analysis|||Statistical analysis at Week 36.||-0.25|-0.87|0.0007
72609528|NCT01668797|144747813|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.51||||0.078|TWO_SIDED|95.0|-1.09|0.06|||Mixed Models Analysis|||Statistical analysis at Week 52.||0.06|-1.09|0.0780
72609529|NCT01668797|144747813|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.35||||0.0006|TWO_SIDED|95.0|-0.54|-0.15|||Mixed Models Analysis|||Statistical analysis at across visits.||-0.15|-0.54|0.0006
72609530|NCT01668797|144747814|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.25||||0.0284|TWO_SIDED|95.0|-0.47|-0.03|||ANCOVA|||Statistical analysis at Week 6.||-0.03|-0.47|0.0284
72609531|NCT01668797|144747814|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.36||||0.0056|TWO_SIDED|95.0|-0.62|-0.11|||ANCOVA|||Statistical analysis at Week 12.||-0.11|-0.62|0.0056
72609532|NCT01668797|144747814|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5||||0.0002|TWO_SIDED|95.0|-0.76|-0.24|||ANCOVA|||Statistical analysis at Week 24.||-0.24|-0.76|0.0002
72609533|NCT01668797|144747814|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.56|||<|0.0001|TWO_SIDED|95.0|-0.82|-0.3|||ANCOVA|||Statistical analysis at Week 36.||-0.30|-0.82|<.0001
72609534|NCT01668797|144747814|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.53||||0.0002|TWO_SIDED|95.0|-0.79|-0.26|||ANCOVA|||Statistical analysis at Week 52||-0.26|-0.79|0.0002
72609535|NCT01668797|144747815|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.31||||0.0387|TWO_SIDED|95.0|-0.6|-0.2|||Cochran-Mantel-Haenszel|||Statistical analysis at Week 6.||-0.20|-0.60|0.0387
72609536|NCT01668797|144747815|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.41||||0.0185|TWO_SIDED|95.0|-0.75|-0.07|||Cochran-Mantel-Haenszel|||Statistical analysis at Week 12.||-0.07|-0.75|0.0185
72609537|NCT01668797|144747815|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.61||||0.001|TWO_SIDED|95.0|-0.97|-0.24|||Cochran-Mantel-Haenszel|||Statistical analysis at Week 24.||-0.24|-0.97|0.0010
72609538|NCT01668797|144747815|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.66||||0.0004|TWO_SIDED|95.0|-1.02|-0.3|||Cochran-Mantel-Haenszel|||Statistical analysis at Week 36.||-0.30|-1.02|0.0004
72609539|NCT01668797|144747815|SUPERIORITY_OR_OTHER||Treatment difference|-0.61||||0.0009|TWO_SIDED|95.0|-0.96|-0.25|||Cochran-Mantel-Haenszel|||Statistical analysis at Week 52.||-0.25|-0.96|0.0009
72609540|NCT01668797|144747816|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.01||||0.6525|TWO_SIDED|95.0|-3.47|5.49|||Mixed Models Analysis|||Statistical analysis at Week 24.||5.49|-3.47|0.6525
72609541|NCT01668797|144747816|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.08||||0.1677|TWO_SIDED|95.0|-2.71|14.87|||Mixed Models Analysis|||Statistical analysis at Week 52.||14.87|-2.71|0.1677
72609542|NCT01668797|144747816|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.55||||0.2347|TWO_SIDED|95.0|-2.41|9.5|||Mixed Models Analysis|||Statistical analysis at across visits.||9.5|-2.41|0.2347
72609543|NCT01668797|144747817|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.79||||0.0285|TWO_SIDED|95.0|0.4|7.17|||ANCOVA|||Statistical analysis at Week 24.||7.17|0.40|0.0285
72609544|NCT01668797|144747817|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.75||||0.0071|TWO_SIDED|95.0|1.31|8.18|||ANCOVA|||Statistical analysis at Week 52.||8.18|1.31|0.0071
72609545|NCT01668797|144747818|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.61||||0.329|TWO_SIDED|95.0|-1.65|4.88|||Mixed Models Analysis|||Statistical analysis at Week 12.||4.88|-1.65|0.3290
72325876|NCT01822665|144175149|SUPERIORITY_OR_OTHER||LS mean difference|0.23||||0.2855|TWO_SIDED|95.0|-0.2|0.65||No multiple comparisons were carried out.|t-test, 2 sided|Period and treatment were included in the model as fixed effects, while subjects were a random effect.|Difference was first named treatment minus second named treatment, such that a positive difference favors the first named treatment.|Null hypothesis considered no significant difference in mean endoscopy score of duodenal mucosal damage between two treatments.||0.65|-0.20|0.2855
72325877|NCT01822665|144175150|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.19||||0.0084|TWO_SIDED|95.0|1.6|23.97||P-value associated with chi-square testing odds ratio.|Chi-squared||Odds Ratio from logistic regression model with treatment as factor and period as covariate.|||23.97|1.60|0.0084
72325878|NCT01822665|144175150|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.19||||0.0999|TWO_SIDED|95.0|0.8|12.74||P-value associated with chi-square testing odds ratio.|Chi-squared||Odds Ratio from logistic regression model with treatment as factor and period as covariate.|||12.74|0.80|0.0999
72325879|NCT01822665|144175150|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.94||||0.2845|TWO_SIDED|95.0|0.58|6.5|||Chi-squared||Odds Ratio from logistic regression model with treatment as factor and period as covariate.|||6.50|0.58|0.2845
72325880|NCT00959907|144175209|SUPERIORITY_OR_OTHER|||||||0.832||95.0|||||t-test, 2 sided|||||||0.832
72325881|NCT00959907|144175210|SUPERIORITY_OR_OTHER|||||||0.658||95.0|||||t-test, 2 sided|||||||0.658
72325882|NCT00959907|144175210|SUPERIORITY_OR_OTHER|||||||0.739||95.0|||||t-test, 2 sided|||||||0.739
72325883|NCT00959907|144175211|SUPERIORITY_OR_OTHER|||||||0.184||95.0|||||t-test, 2 sided|||||||0.184
72325884|NCT03958331|144175212|SUPERIORITY||Mean Difference (Final Values)|10.62|STANDARD_ERROR_OF_MEAN|3.38||0.002|TWO_SIDED|95.0|4.0|17.25|||ANCOVA|Model controlled for baseline adherence, resistance to peer influence, dose, active seizures, COVID timing, COVID Impact (3 items), and sex|||We also conducted a longitudinal mixed effects model for adherence over time, estimating a groupXtime interaction with the same covariates listed above and allowing for a non-linear effect.|17.25|4|0.002
72325885|NCT01722929|144175218|OTHER||||||<|0.0001||||||p-value is for the main effect for the Treatment, Time, and Treatment\*Time interaction.|Mixed Models Analysis|||A mixed ANOVA was performed with the arms as a between factor and the three times as the within factor.||||<0.0001
72325886|NCT01847443|144175233|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was to be established between the test and reference treatment if the 90% CI of ratio of geometric means (Test/Reference) was included within the bioequivalence limits of (0.80, 1.25)|Ratio of Geometric means|1.107|||||TWO_SIDED|90.0|1.07|1.147|||ANOVA|||Null hypothesis stated that there was no difference between the test and reference gums in AUC(0-t)||1.147|1.070|
72325887|NCT01847443|144175238|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was to be established between the test and reference treatment if the 90% CI of ratio of geometric means (Test/Reference) was included within the bioequivalence limits of (0.80, 1.25)|Ratio of Geometric means|1.098|||||TWO_SIDED|90.0|1.061|1.137|||ANOVA|||Null hypothesis stated that there was no difference between the test and reference gums in AUC(0-t)||1.137|1.061|
72325888|NCT01847443|144175239|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was to be established between the test and reference treatment if the 90% CI of ratio of geometric means (Test/Reference) was included within the bioequivalence limits of (0.80, 1.25)|Ratio of Geometric means|1.044|||||TWO_SIDED|90.0|1.002|1.089|||ANOVA|||Null hypothesis stated that there was no difference between the test and reference gums in Cmax||1.089|1.002|
72325889|NCT01847443|144175240|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was to be established between the test and reference treatment if the 90% CI of ratio of geometric means (Test/Reference) was included within the bioequivalence limits of (0.80, 1.25)|Ratio of Geometric means|1.071|||||TWO_SIDED|90.0|1.028|1.116|||ANOVA|||Null hypothesis stated that there was no difference between the test and reference gums in Cmax||1.116|1.028|
72325890|NCT03571971|144175241|SUPERIORITY|Based on published data, we conservatively estimated that the standard exercise (SE) group and load modification (LM) group would have a 20% and 50% treatment success rate, respectively. We defined treatment success as either: 1) at least 'moderately better' on the Global Rating of Change scale or 2) ≥2 point decrease on the Numeric Pain Rating Scale. With one-side type I error=0.1, power=80%, and allocation ratio is 1:1, we estimated the need for 22 participants in each group (total N=44).|Odds Ratio (OR)|1.09||||0.879|TWO_SIDED|95.0|0.36|3.35||The a priori threshold for statistical significance was set at 0.05.|Chi-squared|||||3.35|0.36|0.879
72325891|NCT01911351|144175257|SUPERIORITY_OR_OTHER||kappa statistic|0.88|||<|0.001|TWO_SIDED|||||A priori threshold for statistical significance: p\< or = 0.05|Chi-squared|||A kappa statistic was performed for 75% of the group to assess inter-rater agreement of the perception of the success of the procedure.||||<0.001
72609546|NCT01668797|144747818|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.66||||0.1765|TWO_SIDED|95.0|-1.22|6.54|||Mixed Models Analysis|||Statistical analysis at Week 24.||6.54|-1.22|0.1765
72609547|NCT01668797|144747818|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.5||||0.0331|TWO_SIDED|95.0|0.38|8.63|||Mixed Models Analysis|||Statistical analysis at Week 36.||8.63|0.38|0.0331
72609548|NCT01668797|144747818|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.88||||0.0522|TWO_SIDED|95.0|-0.06|11.82|||Mixed Models Analysis|||Statistical analysis at Week 52.||11.82|-0.06|0.0522
72609549|NCT01668797|144747818|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.66||||0.0281|TWO_SIDED|95.0|0.41|6.92|||Mixed Models Analysis|||Statistical analysis at across visits.||6.92|0.41|0.0281
72609550|NCT01668797|144747819|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.88||||0.0111|TWO_SIDED|95.0|0.9|6.86|||ANCOVA|||Statistical analysis at Week 12.||6.86|0.90|0.0111
72609551|NCT01668797|144747819|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.36||||0.0014|TWO_SIDED|95.0|2.1|8.62|||ANCOVA|||Statistical analysis at Week 24.||8.62|2.10|0.0014
72609552|NCT01668797|144747819|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.81|||<|0.0001|TWO_SIDED|95.0|3.61|10.0|||ANCOVA|||Statistical analysis at Week 36.||10.00|3.61|<.0001
72609553|NCT01668797|144747819|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.55||||0.0001|TWO_SIDED|95.0|3.28|9.83|||ANCOVA|||Statistical analysis at Week 52.||9.83|3.28|0.0001
72609554|NCT01668797|144747820|SUPERIORITY_OR_OTHER|||||||0.0014|TWO_SIDED||||||Log Rank|||||||0.0014
72609555|NCT01668797|144747821|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.43||||0.1577|TWO_SIDED|95.0|-1.02|0.17|||Mixed Models Analysis|||Statistical analysis at Week 6.||0.17|-1.02|0.1577
72609556|NCT01668797|144747821|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.66||||0.1685|TWO_SIDED|95.0|-1.61|0.28|||Mixed Models Analysis|||Statistical analysis at Week 12.||0.28|-1.61|0.1685
72609557|NCT01668797|144747821|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5||||0.2815|TWO_SIDED|95.0|-1.43|0.42|||Mixed Models Analysis|||Statistical analysis at Week 24.||0.42|-1.43|0.2815
72609558|NCT01668797|144747821|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.14||||0.0286|TWO_SIDED|95.0|-2.16|-0.12|||Mixed Models Analysis|||Statistical analysis at Week 36.||-0.12|-2.16|0.0286
72609559|NCT01668797|144747821|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.03||||0.1803|TWO_SIDED|95.0|-2.58|0.51|||Mixed Models Analysis|||Statistical analysis at Week 52.||0.51|-2.58|0.1803
72609560|NCT01668797|144747821|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.65||||0.0077|TWO_SIDED|95.0|-1.12|-0.17|||Mixed Models Analysis|||Statistical analysis at across visits.||-0.17|-1.12|0.0077
72609561|NCT01668797|144747822|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.42||||0.1852|TWO_SIDED|95.0|-1.06|0.21|||ANCOVA|||Statistical analysis at Week 6.||0.21|-1.06|0.1852
72609562|NCT01668797|144747822|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.63||||0.143|TWO_SIDED|95.0|-1.47|0.21|||ANCOVA|||Statistical analysis at Week 12.||0.21|-1.47|0.1430
72609563|NCT01668797|144747822|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.08||||0.0323|TWO_SIDED|95.0|-2.06|-0.09|||ANCOVA|||Statistical analysis at Week 24.||-0.09|-2.06|0.0323
72609564|NCT01668797|144747822|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.34||||0.0071|TWO_SIDED|95.0|-2.31|-0.37|||ANCOVA|||Statistical analysis at Week 36.||-0.37|-2.31|0.0071
72609565|NCT01668797|144747822|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.54||||0.0023|TWO_SIDED|95.0|-2.52|-0.56|||ANCOVA|||Statistical analysis at Week 52.||-0.56|-2.52|0.0023
72609566|NCT01668797|144747823|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.34||||0.0288|TWO_SIDED|95.0|-2.54|-0.14|||Mixed Models Analysis|||Statistical analysis at Week 6.||-0.14|-2.54|0.0288
72609567|NCT01668797|144747823|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.02||||0.0128|TWO_SIDED|95.0|-3.6|-0.44|||Mixed Models Analysis|||Statistical analysis at Week 12.||-0.44|-3.60|0.0128
72609568|NCT01668797|144747823|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.59||||0.0462|TWO_SIDED|95.0|-3.15|0.03|||Mixed Models Analysis|||Statistical analysis at Week 24.||0.03|-3.15|0.0462
72609569|NCT01668797|144747823|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.29||||0.0074|TWO_SIDED|95.0|-3.94|-0.64|||Mixed Models Analysis|||Statistical analysis at Week 36.||-0.64|-3.94|0.0074
72609570|NCT01668797|144747823|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.4||||0.0136|TWO_SIDED|95.0|-6.05|-0.75|||Mixed Models Analysis|||Statistical analysis at Week 52||-0.75|-6.05|0.0136
72609571|NCT01668797|144747823|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.91||||0.0001|TWO_SIDED|95.0|-2.84|-0.97|||Mixed Models Analysis|||Statistical analysis at across visits.||-0.97|-2.84|0.0001
72609572|NCT01668797|144747824|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.08||||0.0695|TWO_SIDED|95.0|-2.26|0.09|||ANCOVA|||Statistical analysis at Week 6.||0.09|-2.26|0.0695
72609573|NCT01668797|144747824|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.93||||0.0089|TWO_SIDED|95.0|-3.38|-0.49|||ANCOVA|||Statistical analysis at Week 12.||-0.49|-3.38|0.0089
72609574|NCT01668797|144747824|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.83||||0.0004|TWO_SIDED|95.0|-4.39|-1.27|||ANCOVA|||Statistical analysis at Week 24.||-1.27|-4.39|0.0004
72609575|NCT01668797|144747824|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.09||||0.0001|TWO_SIDED|95.0|-4.63|-1.54|||ANCOVA|||Statistical analysis at Week 36.||-1.54|-4.63|0.0001
72609576|NCT01668797|144747824|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.44|||<|0.0001|TWO_SIDED|95.0|-4.99|-1.89|||ANCOVA|||Statistical analysis at Week 52.||-1.89|-4.99|<0.0001
72609577|NCT01668797|144747825|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.66||||0.1969|TWO_SIDED|95.0|-1.66|0.35|||Mixed Models Analysis|||Statistical analysis at Week 6.||0.35|-1.66|0.1969
72609578|NCT01668797|144747825|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8||||0.2007|TWO_SIDED|95.0|-2.04|0.43|||Mixed Models Analysis|||Statistical analysis at Week 12.||0.43|-2.04|0.2007
72609579|NCT01668797|144747825|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.17||||0.0436|TWO_SIDED|95.0|-2.3|-0.03|||Mixed Models Analysis|||Statistical analysis at Week 24.||-0.03|-2.30|0.0436
72609580|NCT01668797|144747825|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.51||||0.0444|TWO_SIDED|95.0|-2.97|-0.04|||Mixed Models Analysis|||Statistical analysis at Week 36.||-0.04|-2.97|0.0444
72609581|NCT01668797|144747825|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.31||||0.8927|TWO_SIDED|95.0|-4.4|5.02|||Mixed Models Analysis|||Statistical analysis at Week 52.||5.02|-4.40|0.8927
72609582|NCT01668797|144747825|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.52||||0.2154|TWO_SIDED|95.0|-1.34|0.31|||Mixed Models Analysis|||Statistical analysis at across visits.||0.31|-1.34|0.2154
72609583|NCT01668797|144747826|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.85||||0.0707|TWO_SIDED|95.0|-1.78|0.07|||ANCOVA|||Statistical analysis at Week 6.||0.07|-1.78|0.0707
72609584|NCT01668797|144747826|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.24||||0.0276|TWO_SIDED|95.0|-2.35|-0.14|||ANCOVA|||Statistical analysis at Week 12.||-0.14|-2.35|0.0276
72609585|NCT01668797|144747826|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.59||||0.0065|TWO_SIDED|95.0|-2.72|-0.45|||ANCOVA|||Statistical analysis at Week 24.||-0.45|-2.72|0.0065
72609586|NCT01668797|144747826|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.63||||0.0085|TWO_SIDED|95.0|-2.84|-0.42|||ANCOVA|||Statistical analysis at Week 36.||-0.42|-2.84|0.0085
72325892|NCT03848455|144175258|OTHER||||||<|0.001|||||||Kruskal-Wallis|||we use the method of RT-PCR to detect the relative expression level of PPP2CA gene in Parkinson's disease group(90 participants), healthy controls group(125 participants) and Parkinson-plus syndrome group(23 participants).This gene expression is relative to a house keeping gene GAPDH.The data were processed using 2-△△Ct. ΔCT(test) = CT(target, test) - CT(ref, test), ΔCT(calibrator) = CT(target, calibrator) - CT(ref, calibrator),ΔΔCT = ΔCT(test) - ΔCT(calibrator).||||<0.001
72325893|NCT03848455|144175258|OTHER||||||<|0.001|||||||Kruskal-Wallis|||we use the method of RT-PCR to detect the relative expression level of SYNJ1 gene in Parkinson's disease group(90 participants), healthy controls group(125 participants) and Parkinson-plus syndrome group(23 participants).This gene expression is relative to a house keeping gene GAPDH.The data were processed using 2-△△Ct. ΔCT(test) = CT(target, test) - CT(ref, test), ΔCT(calibrator) = CT(target, calibrator) - CT(ref, calibrator),ΔΔCT = ΔCT(test) - ΔCT(calibrator).||||<0.001
72325894|NCT03848455|144175258|OTHER|||||||0.149|||||||Kruskal-Wallis|||we use the method of RT-PCR to detect the relative expression level of PPP3CB gene in Parkinson's disease group(90 participants), healthy controls group(125 participants) and Parkinson-plus syndrome group(23 participants).This gene expression is relative to a house keeping gene GAPDH.The data were processed using 2-△△Ct. ΔCT(test) = CT(target, test) - CT(ref, test), ΔCT(calibrator) = CT(target, calibrator) - CT(ref, calibrator),ΔΔCT = ΔCT(test) - ΔCT(calibrator).||||0.149
72325895|NCT03848455|144175258|OTHER||||||<|0.001|||||||Kruskal-Wallis|||we use the method of RT-PCR to detect the relative expression level of NSF gene in Parkinson's disease group(90 participants), healthy controls group(125 participants) and Parkinson-plus syndrome group(23 participants).This gene expression is relative to a house keeping gene GAPDH.The data were processed using 2-△△Ct. ΔCT(test) = CT(target, test) - CT(ref, test), ΔCT(calibrator) = CT(target, calibrator) - CT(ref, calibrator),ΔΔCT = ΔCT(test) - ΔCT(calibrator).||||<0.001
72325896|NCT04046939|144175261|SUPERIORITY||Ratio to PBO of the ratios to baseline|0.2283|||<|0.0001|TWO_SIDED|95.0|0.121|0.431||A closed hierarchical procedure testing dexpramipexole against placebo at Week 12 was used. (1) 150 mg BID for AEC (2) 75 mg BID for AEC (3) pooled 75 mg and 150 mg BID group for pre-bronchodilator FEV1; and (4) 37.5 mg BID for AEC.|Mixed Models Analysis||0.2283 represents the ratio of the 150 mg BID week 12 ratio to baseline (0.2051), compared to the PBO week 12 ratio to baseline (0.8980). This ratio of 0.2283 is equivalent to a -77.17% change compared to placebo at week 12.|The 150 mg BID dexpramipexole group was compared to placebo using a mixed effects model repeated-measures (MMRM).||0.431|0.121|<.0001
72325897|NCT04046939|144175261|SUPERIORITY||Ratio to PBO of the ratios to baseline|0.3403||||0.0014|TWO_SIDED|95.0|0.177|0.653||A closed hierarchical procedure testing dexpramipexole against placebo at Week 12 was used. (1) 150 mg BID for AEC (2) 75 mg BID for AEC (3) pooled 75 mg and 150 mg BID group for pre-bronchodilator FEV1; and (4) 37.5 mg BID for AEC.|Mixed Models Analysis||0.3403 represents the ratio of the 75 mg BID week 12 ratio to baseline (0.3056), compared to the PBO week 12 ratio to baseline (0.8980). This ratio of 0.3403 is equivalent to a -65.97% change compared to placebo at week 12.|The 75 mg BID dexpramipexole group was compared to placebo using a mixed effects model repeated-measures (MMRM).||0.653|0.177|0.0014
72325898|NCT04046939|144175261|SUPERIORITY||Ratio to PBO of the ratios to baseline|0.4489||||0.019|TWO_SIDED|95.0|0.231|0.874||A closed hierarchical statistical testing was used. The previous endpoint in the hierarchy was not statistically significant. Therefore, this endpoint was not formally tested and is not considered statistically significant, despite a p-value \<0.05.|Mixed Models Analysis||0.4489 represents the ratio of the 37.5 mg BID week 12 ratio to baseline (0.4031) compared to the PBO week 12 ratio to baseline (0.8980). This ratio of 0.4489 is equivalent to a -55.11% change compared to placebo at week 12.|The 37.5 mg BID dexpramipexole group was compared to placebo using a mixed effects model repeated-measures (MMRM).||0.874|0.231|0.0190
72325899|NCT04046939|144175262|SUPERIORITY||Mean Difference (Final Values)|0.0814||||0.4154|TWO_SIDED|95.0|-0.116|0.279||A closed hierarchical procedure testing dexpramipexole against placebo at Week 12 was used. (1) 150 mg BID for AEC (2) 75 mg BID for AEC (3) pooled 75 mg and 150 mg BID group for pre-bronchodilator FEV1; and (4) 37.5 mg BID for AEC.|Mixed Models Analysis||Estimate is the difference of the pooled 75 mg and 150 mg BID group from placebo in change in pre-bronchodilator FEV1 in liters from Baseline to Week 12 (end of primary treatment period). A positive value indicates improvement in lung function.|The combined 75 mg and 150 mg BID dexpramipexole group was compared to placebo using a mixed effects model repeated-measures (MMRM).||0.279|-0.116|0.4154
72325900|NCT04046939|144175262|SUPERIORITY||Mean Difference (Final Values)|0.177||||0.1174|TWO_SIDED|95.0|-0.0456|0.4||For secondary endpoints which were not key secondary endpoints, no adjustment for multiple testing was used and p \<0.05 was used for statistical significance.|Mixed Models Analysis||Estimate is the difference of the 150 mg BID group from the placebo group in the change in pre-bronchodilator FEV1 in liters from Baseline to Week 12 (end of primary treatment period). A positive value indicates improvement in lung function.|The 150 mg BID dexpramipexole group was compared to placebo using a mixed effects model repeated-measures (MMRM).||0.400|-0.0456|0.1174
72609587|NCT01668797|144747826|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.23||||0.063|TWO_SIDED|95.0|-2.52|0.07|||ANCOVA|||Statistical analysis at Week 52.||0.07|-2.52|0.0630
72609588|NCT01668797|144747827|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.51||||0.2251|TWO_SIDED|95.0|-1.33|0.31|||Mixed Models Analysis|||Statistical analysis at Week 6.||0.31|-1.33|0.2251
72609589|NCT01668797|144747827|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.13||||0.0368|TWO_SIDED|95.0|-2.19|-0.07|||Mixed Models Analysis|||Statistical analysis at Week 12.||-0.07|-2.19|0.0368
72609590|NCT01668797|144747827|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.53||||0.0024|TWO_SIDED|95.0|-2.51|-0.56|||Mixed Models Analysis|||Statistical analysis at Week 24.||-0.56|-2.51|0.0024
72609591|NCT01668797|144747827|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.48||||0.0293|TWO_SIDED|95.0|-2.8|-0.15|||Mixed Models Analysis|||Statistical analysis at Week 36.||-0.15|-2.80|0.0293
72609592|NCT01668797|144747827|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.07||||0.9632|TWO_SIDED|95.0|-3.32|3.17|||Mixed Models Analysis|||Statistical analysis at Week 52.||3.17|-3.32|0.9632
72609593|NCT01668797|144747827|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.99||||0.0029|TWO_SIDED|95.0|-1.63|-0.34|||Mixed Models Analysis|||Statistical analysis at across visits.||-0.34|-1.63|0.0029
72609594|NCT01668797|144747828|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.65||||0.1062|TWO_SIDED|95.0|-1.44|0.14|||ANCOVA|||Statistical analysis at Week 6.||0.14|-1.44|0.1062
72609595|NCT01668797|144747828|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.37||||0.0051|TWO_SIDED|95.0|-2.33|-0.42|||ANCOVA|||Statistical analysis at Week 12.||-0.42|-2.33|0.0051
72609596|NCT01668797|144747828|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.05||||0.0001|TWO_SIDED|95.0|-3.08|-1.01|||ANCOVA|||Statistical analysis at Week 24.||-1.01|-3.08|0.0001
72609597|NCT01668797|144747828|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.94||||0.0004|TWO_SIDED|95.0|-3.0|-0.89|||ANCOVA|||Statistical analysis at Week 36.||-0.89|-3.00|0.0004
72609598|NCT01668797|144747828|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.69||||0.0035|TWO_SIDED|95.0|-2.81|-0.56|||ANCOVA|||Statistical analysis at Week 52.||-0.56|-2.81|0.0035
72609599|NCT01668797|144747829|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.36||||0.1465|TWO_SIDED|95.0|-0.85|0.13|||Mixed Models Analysis|||Statistical analysis at Week 6.||0.13|-0.85|0.1465
72609600|NCT01668797|144747829|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.49||||0.2154|TWO_SIDED|95.0|-1.27|0.29|||Mixed Models Analysis|||Statistical analysis at Week 12.||0.29|-1.27|0.2154
72609601|NCT01668797|144747829|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.44||||0.2696|TWO_SIDED|95.0|-1.23|0.35|||Mixed Models Analysis|||Statistical analysis at Week 24.||0.35|-1.23|0.2696
72609602|NCT01668797|144747829|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.07||||0.0179|TWO_SIDED|95.0|-1.95|-0.19|||Mixed Models Analysis|||Statistical analysis at Week 36.||-0.19|-1.95|0.0179
72609603|NCT01668797|144747829|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.14||||0.0875|TWO_SIDED|95.0|-2.46|0.18|||Mixed Models Analysis|||Statistical analysis at Week 52.||0.18|-2.46|0.0875
72609604|NCT01668797|144747829|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.66||||0.0021|TWO_SIDED|95.0|-1.08|-0.24|||Mixed Models Analysis|||Statistical analysis at across visits.||-0.24|-1.08|0.0021
72609605|NCT01668797|144747830|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.33||||0.2135|TWO_SIDED|95.0|-0.86|0.19|||ANCOVA|||Statistical analysis at Week 6.||0.19|-0.86|0.2135
72609606|NCT01668797|144747830|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.42||||0.2437|TWO_SIDED|95.0|-1.13|0.29|||ANCOVA|||Statistical analysis at Week 12.||0.29|-1.13|0.2437
72609607|NCT01668797|144747830|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.81||||0.0635|TWO_SIDED|95.0|-1.66|0.05|||ANCOVA|||Statistical analysis at Week 24.||0.05|-1.66|0.0635
72609608|NCT01668797|144747830|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.07||||0.0144|TWO_SIDED|95.0|-1.92|-0.22|||ANCOVA|||Statistical analysis at Week 36.||-0.22|-1.92|0.0144
72609609|NCT01668797|144747830|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.26||||0.0046|TWO_SIDED|95.0|-2.12|-0.39|||ANCOVA|||Statistical analysis at Week 52.||-0.39|-2.12|0.0046
72609610|NCT01668797|144747831|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.47||||0.164|TWO_SIDED|95.0|-1.14|0.19|||Mixed Models Analysis|||Statistical analysis at Week 6.||0.19|-1.14|0.1640
72609611|NCT01668797|144747831|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.24||||0.5466|TWO_SIDED|95.0|-1.04|0.55|||Mixed Models Analysis|||Statistical analysis at Week 12.||0.55|-1.04|0.5466
72609612|NCT01668797|144747831|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.03||||0.9417|TWO_SIDED|95.0|-0.81|0.87|||Mixed Models Analysis|||Statistical analysis at Week 24.||0.87|-0.81|0.9417
72609613|NCT01668797|144747831|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.25||||0.6257|TWO_SIDED|95.0|-1.25|0.76|||Mixed Models Analysis|||Statistical analysis at Week 36.||0.76|-1.25|0.6257
72609614|NCT01668797|144747831|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.23||||0.7437|TWO_SIDED|95.0|-1.68|1.21|||Mixed Models Analysis|||Statistical analysis at Week 52.||1.21|-1.68|0.7437
72609615|NCT01668797|144747831|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.17||||0.4506|TWO_SIDED|95.0|-0.62|0.28|||Mixed Models Analysis|||Statistical analysis at across visits.||0.28|-0.62|0.4506
72609616|NCT01668797|144747832|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.67||||0.0467|TWO_SIDED|95.0|-1.32|-0.06|||ANCOVA|||Statistical analysis at Week 6.||-0.06|-1.32|0.0467
72609617|NCT01668797|144747832|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.55||||0.1599|TWO_SIDED|95.0|-1.33|0.22|||ANCOVA|||Statistical analysis at Week 12.||0.22|-1.33|0.1599
72609618|NCT01668797|144747832|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.58||||0.1417|TWO_SIDED|95.0|-1.35|0.19|||ANCOVA|||Statistical analysis at Week 24.||0.19|-1.35|0.1417
72609619|NCT01668797|144747832|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7||||0.0724|TWO_SIDED|95.0|-1.47|0.06|||ANCOVA|||Statistical analysis at Week 36.||0.06|-1.47|0.0724
72609620|NCT01668797|144747832|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.72||||0.0608|TWO_SIDED|95.0|-1.47|0.03|||ANCOVA|||Statistical analysis at Week 52.||0.03|-1.47|0.0608
72609621|NCT02530385|144747833|SUPERIORITY|||||||0.16|||||||Wilcoxon (Mann-Whitney)|||||||0.16
72609622|NCT02530385|144747834|SUPERIORITY|||||||0.7|||||||Mixed Models Analysis|||||||0.70
72609623|NCT02530385|144747835|SUPERIORITY|||||||0.93|||||||Mixed Models Analysis|||||||0.93
72609624|NCT02530385|144747836|SUPERIORITY|||||||0.9|||||||Mixed Models Analysis|||||||0.90
72609625|NCT02530385|144747837|SUPERIORITY|||||||0.32|||||||Mixed Models Analysis|||||||0.32
72609626|NCT01569022|144747839|EQUIVALENCE|The primary endpoint of the study was tested by comparing difference in residual AHI using the paired t test|||||<|0.001|||||||t-test, 2 sided|||||||<0.001
72609627|NCT01569022|144747840|EQUIVALENCE|t test assuming unequal variance||||||0.97|||||||t-test, 2 sided|||ESS||||0.97
72609628|NCT01569022|144747840|EQUIVALENCE|t test assuming unequal variance||||||0.98|||||||t-test, 2 sided|||PCL||||0.98
72609629|NCT01569022|144747840|EQUIVALENCE|t-test assuming non unequal variance||||||0.31|||||||t-test, 2 sided|||PSQI||||0.31
72609630|NCT01569022|144747841|EQUIVALENCE|t test assuming unequal variance||||||0.54|||||||t-test, 2 sided|||||||0.54
72609631|NCT01569022|144747842|EQUIVALENCE|t test assuming unequal variance|||||<|0.001|||||||t-test, 2 sided|||||||<0.001
72609632|NCT02111083|144747844|SUPERIORITY_OR_OTHER||Ratio of geometric least square means|0.986|||||TWO_SIDED|90.0|0.965|1.01||||||||1.01|0.965|
72418005|NCT01212770|144346327|SUPERIORITY||Adjusted Difference|10.4||||0.0372|TWO_SIDED|95.0|0.8|20.0|||Cochran-Mantel-Haenszel|Two-sided p-value based on the Cochran-Mantel-Haenszel (CMH) test adjusting for baseline DMARD use and ≥ 3% BSA psoriasis involvement at baseline.|Adjusted difference is the weighted average of the treatment differences across 4 strata of baseline DMARD use by ≥ 3% BSA psoriasis involvement at baseline with the CMH weights. The 95% CI is based on a normal approximation to the weighted average.|Secondary endpoints from the placebo-controlled period (Weeks 16 and 24) were analyzed in a hierarchical fashion to control the Type I error rate as described above.||20.0|0.8|0.0372
72418006|NCT01212770|144346328|SUPERIORITY||Adjusted Difference|14.6||||0.0062|TWO_SIDED|95.0|4.5|24.8|||Cochran-Mantel-Haenszel|Two-sided p-value based on the Cochran-Mantel-Haenszel (CMH) test adjusting for baseline DMARD use.|Adjusted difference is the weighted average of the treatment differences across 2 strata of baseline DMARD use with the CMH weights. The 95% CI is based on a normal approximation to the weighted average.|Secondary endpoints from the placebo-controlled period (Weeks 16 and 24) were analyzed in a hierarchical fashion to control the Type I error rate as described above.||24.8|4.5|0.0062
72418007|NCT01212770|144346328|SUPERIORITY||Adjusted Difference|13.0||||0.0134|TWO_SIDED|95.0|3.0|23.1|||Cochran-Mantel-Haenszel|Two-sided p-value based on the Cochran-Mantel-Haenszel (CMH) test adjusting for baseline DMARD use.|Adjusted difference is the weighted average of the treatment differences across 2 strata of baseline DMARD use with the CMH weights. The 95% CI is based on a normal approximation to the weighted average.|Secondary endpoints from the placebo-controlled period (Weeks 16 and 24) were analyzed in a hierarchical fashion to control the Type I error rate as described above.||23.1|3.0|0.0134
72418008|NCT01212770|144346329|SUPERIORITY||LS Mean Difference|-7.8||||0.0021|TWO_SIDED|95.0|-12.8|-2.9|||ANCOVA|Based on an ANCOVA model with treatment group, baseline DMARD use and ≥ 3% BSA psoriasis involvement as factors and the baseline value as a covariate.||Secondary endpoints from the placebo-controlled period (Weeks 16 and 24) were analyzed in a hierarchical fashion to control the Type I error rate as described above.||-2.9|-12.8|0.0021
72418009|NCT01212770|144346329|SUPERIORITY||LS Mean Difference|-3.6||||0.1482|TWO_SIDED|95.0|-8.6|1.3|||ANCOVA|Based on an ANCOVA model with treatment group, baseline DMARD use and ≥ 3% BSA psoriasis involvement as factors and the baseline value as a covariate.||Secondary endpoints from the placebo-controlled period (Weeks 16 and 24) were analyzed in a hierarchical fashion to control the Type I error rate as described above.||1.3|-8.6|0.1482
72418010|NCT01212770|144346330|SUPERIORITY||LS Mean Difference|-0.2||||0.5349|TWO_SIDED|95.0|-1.0|0.5|||ANCOVA|Based on an ANCOVA model with treatment group, baseline DMARD use and ≥ 3% BSA psoriasis involvement as factors and the baseline value as a covariate.||||0.5|-1.0|0.5349
72418011|NCT01212770|144346330|SUPERIORITY||LS Mean Difference|0.1||||0.8231|TWO_SIDED|95.0|-0.7|0.9|||ANCOVA|Based on an ANCOVA model with treatment group, baseline DMARD use and ≥ 3% BSA psoriasis involvement as factors and the baseline value as a covariate.||||0.9|-0.7|0.8231
72418012|NCT01212770|144346331|SUPERIORITY||LS Mean Difference|-0.8||||0.072|TWO_SIDED|95.0|-1.7|0.1|||ANCOVA|Based on an ANCOVA model with treatment group, baseline DMARD use and ≥ 3% BSA psoriasis involvement as factors and the baseline value as a covariate.||||0.1|-1.7|0.0720
72418013|NCT01212770|144346331|SUPERIORITY||LS Mean Difference|-0.4||||0.3641|TWO_SIDED|95.0|-1.3|0.5|||ANCOVA|Based on an ANCOVA model with treatment group, baseline DMARD use and ≥ 3% BSA psoriasis involvement as factors and the baseline value as a covariate.||||0.5|-1.3|0.3641
72325901|NCT04046939|144175262|SUPERIORITY||Mean Difference (Final Values)|-0.0143||||0.8998|TWO_SIDED|95.0|-0.24|0.211||For secondary endpoints which were not key secondary endpoints, no adjustment for multiple testing was used and p \<0.05 was used for statistical significance.|Mixed Models Analysis||Estimate is the difference of the 75 mg BID group from the placebo group in the change in pre-bronchodilator FEV1 in liters from Baseline to Week 12 (end of primary treatment period). A positive value indicates improvement in lung function.|The 75 mg BID dexpramipexole group was compared to placebo using a mixed effects model repeated-measures (MMRM).||0.211|-0.240|0.8998
72325902|NCT04046939|144175262|SUPERIORITY||Mean Difference (Final Values)|0.138||||0.2425|TWO_SIDED|95.0|-0.095|0.37||For secondary endpoints which were not key secondary endpoints, no adjustment for multiple testing was used and p \<0.05 was used for statistical significance.|Mixed Models Analysis||Estimate is the difference of the 37.5 mg BID group from the placebo group in the change in pre-bronchodilator FEV1 in liters from Baseline to Week 12 (end of primary treatment period). A positive value indicates improvement in lung function.|The 37.5 mg BID dexpramipexole group was compared to placebo using a mixed effects model repeated-measures (MMRM).||0.370|-0.0950|0.2425
72418014|NCT01212770|144346332|SUPERIORITY||LS Mean Difference|-4.94||||0.0001|TWO_SIDED|95.0|-7.34|-2.53|||ANCOVA|Based on an ANCOVA model with treatment group, baseline DMARD use and ≥ 3% BSA psoriasis involvement as factors and the baseline value as a covariate.||||-2.53|-7.34|0.0001
72418015|NCT01212770|144346332|SUPERIORITY||LS Mean Difference|-1.85||||0.1325|TWO_SIDED|95.0|-4.27|0.56|||ANCOVA|Based on an ANCOVA model with treatment group, baseline DMARD use and ≥ 3% BSA psoriasis involvement as factors and the baseline value as a covariate.||||0.56|-4.27|0.1325
72418016|NCT01212770|144346333|SUPERIORITY||LS Mean Difference|-0.47||||0.0001|TWO_SIDED|95.0|-0.7|-0.24|||ANCOVA|Based on an ANCOVA model with treatment group, baseline DMARD use and ≥ 3% BSA psoriasis involvement as factors and the baseline value as a covariate.||||-0.24|-0.70|0.0001
72418017|NCT01212770|144346333|SUPERIORITY||LS Mean Difference|-0.27||||0.0237|TWO_SIDED|95.0|-0.5|-0.04|||ANCOVA|Based on an ANCOVA model with treatment group, baseline DMARD use and ≥ 3% BSA psoriasis involvement as factors and the baseline value as a covariate.||||-0.04|-0.50|0.0237
72418018|NCT01212770|144346334|SUPERIORITY||LS Mean Difference|2.54||||0.0049|TWO_SIDED|95.0|0.77|4.3|||ANCOVA|Based on an ANCOVA model with treatment group, baseline DMARD use and ≥ 3% BSA psoriasis involvement as factors and the baseline value as a covariate.||||4.30|0.77|0.0049
72418019|NCT01212770|144346334|SUPERIORITY||LS Mean Difference|0.68||||0.4505|TWO_SIDED|95.0|-1.09|2.44|||ANCOVA|Based on an ANCOVA model with treatment group, baseline DMARD use and ≥ 3% BSA psoriasis involvement as factors and the baseline value as a covariate.||||2.44|-1.09|0.4505
72418020|NCT01212770|144346335|SUPERIORITY||LS Mean Difference|2.34||||0.0043|TWO_SIDED|95.0|0.74|3.94|||ANCOVA|Based on an ANCOVA model with treatment group, baseline DMARD use and ≥ 3% BSA psoriasis involvement as factors and the baseline value as a covariate.||||3.94|0.74|0.0043
72418021|NCT01212770|144346335|SUPERIORITY||LS Mean Difference|1.67||||0.0404|TWO_SIDED|95.0|0.07|3.27|||ANCOVA|Based on an ANCOVA model with treatment group, baseline DMARD use and ≥ 3% BSA psoriasis involvement as factors and the baseline value as a covariate.||||3.27|0.07|0.0404
72418022|NCT01212770|144346336|SUPERIORITY||Adjusted Difference|21.2|||<|0.0001|TWO_SIDED|95.0|11.5|30.9|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use and and involvement of \>= 3% BSA with psoriasis at baseline.|Adjusted difference is the weighted average of the treatment differences across 4 strata of baseline DMARD use by ≥ 3% BSA psoriasis involvement at baseline with the CMH weights. The 95% CI is based on a normal approximation to the weighted average.|||30.9|11.5|< 0.0001
72418023|NCT01212770|144346336|SUPERIORITY||Adjusted Difference|8.7||||0.0661|TWO_SIDED|95.0|-0.5|18.0|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use involvement of \>= 3% BSA with psoriasis at baseline.|Adjusted difference is the weighted average of the treatment differences across 4 strata of baseline DMARD use by ≥ 3% BSA psoriasis involvement at baseline with the CMH weights. The 95% CI is based on a normal approximation to the weighted average.|||18.0|-0.5|0.0661
72418024|NCT01212770|144346337|SUPERIORITY||Adjusted Difference|14.8||||0.0099|TWO_SIDED|95.0|3.8|25.7|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use|Adjusted difference is the weighted average of the treatment differences across 2 strata of baseline DMARD use with the CMH weights. The 95% CI is based on a normal approximation to the weighted average.|||25.7|3.8|0.0099
72418025|NCT01212770|144346337|SUPERIORITY||Adjusted Difference|10.8||||0.0515|TWO_SIDED|95.0|0.1|21.4|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use|Adjusted difference is the weighted average of the treatment differences across 2 strata of baseline DMARD use with the CMH weights. The 95% CI is based on a normal approximation to the weighted average.|||21.4|0.1|0.0515
72418026|NCT01212770|144346338|SUPERIORITY||LS mean Difference|-6.6||||0.008|TWO_SIDED|95.0|-11.4|-1.7|||ANCOVA|Based on an ANCOVA model with treatment group, baseline DMARD use and ≥ 3% BSA psoriasis involvement as factors and the baseline value as a covariate.||||-1.7|-11.4|0.0080
72418027|NCT01212770|144346338|SUPERIORITY||LS Mean Difference|-3.8||||0.1218|TWO_SIDED|95.0|-8.6|1.0|||ANCOVA|Based on an ANCOVA model with treatment group, baseline DMARD use and ≥ 3% BSA psoriasis involvement as factors and the baseline value as a covariate.||||1.0|-8.6|0.1218
72418028|NCT01212770|144346339|SUPERIORITY||LS Mean Difference|-0.4||||0.2761|TWO_SIDED|95.0|-1.3|0.4|||ANCOVA|Based on an ANCOVA model with treatment group, baseline DMARD use and ≥ 3% BSA psoriasis involvement as factors and the baseline value as a covariate.||||0.4|-1.3|0.2761
72418029|NCT01212770|144346339|SUPERIORITY||LS Mean Difference|-0.3||||0.5012|TWO_SIDED|95.0|-1.1|0.6|||ANCOVA|Based on an ANCOVA model with treatment group, baseline DMARD use and ≥ 3% BSA psoriasis involvement as factors and the baseline value as a covariate.||||0.6|-1.1|0.5012
72609633|NCT02111083|144747845|SUPERIORITY_OR_OTHER||Ratio of geometric least square means|0.872|||||TWO_SIDED|90.0|0.828|0.919||||||||0.919|0.828|
72609634|NCT02111083|144747846|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.25|||||TWO_SIDED|90.0|0.0|0.375||||||||0.375|0|
72609635|NCT02111083|144747847|SUPERIORITY_OR_OTHER||Ratio of geometric least square means|0.986|||||TWO_SIDED|90.0|0.954|1.02||||||||1.02|0.954|
72609636|NCT02111083|144747848|SUPERIORITY_OR_OTHER||Ratio of geometric least square means|0.95|||||TWO_SIDED|90.0|0.901|1.0||||||||1.00|0.901|
72609637|NCT02111083|144747849|SUPERIORITY_OR_OTHER||Difference of least squares means|0.424|||||TWO_SIDED|90.0|0.164|0.685||||||||0.685|0.164|
72609638|NCT02111083|144747850|SUPERIORITY_OR_OTHER||Ratio of geometric least square means|0.992|||||TWO_SIDED|90.0|0.975|1.01||||||||1.01|0.975|
72609639|NCT00433836|144747851|NON_INFERIORITY_OR_EQUIVALENCE|non-inferiority delta of 3.5 mm Hg|Mean Difference (Final Values)|-1.3|||||TWO_SIDED|95.0|-3.8|1.17|||ANOVA|||||1.17|-3.80|
72609640|NCT01026493|144747879|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.99||||0.95|TWO_SIDED|95.0|0.66|1.48|||Log Rank|Two-sided test|Reference level = Arm 1/BEV-NAIVE|||1.48|0.66|0.95
72609641|NCT01026493|144747879|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.93||||0.93|TWO_SIDED|95.0|0.57|1.53|||Log Rank|Two-sided test|Reference level = Arm 1/BEV-FAILURE|||1.53|0.57|0.93
72609642|NCT03307174|144747887|SUPERIORITY|||||||0.74|||||||Wilcoxon (Mann-Whitney)|||||||0.74
72609643|NCT00721799|144747911|OTHER||Hazard Ratio (HR)|0.47||||0.08|TWO_SIDED||||||Regression, Cox|||||||0.08
72609644|NCT00721799|144747911|OTHER||C-statistic|0.73||||0.04|TWO_SIDED||||||Regression, Cox|||||||0.04
72609645|NCT00721799|144747912|OTHER||Hazard Ratio (HR)|0.42||||0.05|TWO_SIDED||||||Regression, Cox|||||||0.05
72418030|NCT01212770|144346340|SUPERIORITY||LS Mean Difference|-1.0||||0.0399|TWO_SIDED|95.0|-1.9|0.0|||ANCOVA|Based on an ANCOVA model with treatment group, baseline DMARD use and ≥ 3% BSA psoriasis involvement as factors and the baseline value as a covariate.||||-0.0|-1.9|0.0399
72418031|NCT01212770|144346340|SUPERIORITY||LS Mean Difference|-0.4||||0.4413|TWO_SIDED|95.0|-1.3|0.6|||ANCOVA|Based on an ANCOVA model with treatment group, baseline DMARD use and ≥ 3% BSA psoriasis involvement as factors and the baseline value as a covariate.||||0.6|-1.3|0.4413
72418032|NCT01212770|144346341|SUPERIORITY||LS Mean Difference|-5.27|||<|0.0001|TWO_SIDED|95.0|-7.73|-2.82|||ANCOVA|Based on an ANCOVA model with treatment group, baseline DMARD use and ≥ 3% BSA psoriasis involvement as factors and the baseline value as a covariate.||||-2.82|-7.73|< 0.0001
72418033|NCT01212770|144346341|SUPERIORITY||LS Mean Difference|-2.65||||0.0349|TWO_SIDED|95.0|-5.11|-0.19|||ANCOVA|Based on an ANCOVA model with treatment group, baseline DMARD use and ≥ 3% BSA psoriasis involvement as factors and the baseline value as a covariate.||||-0.19|-5.11|0.0349
72609646|NCT00721799|144747912|OTHER||C-statistic|0.75||||0.02|TWO_SIDED||||||Regression, Cox|||||||0.02
72609647|NCT00721799|144747913|OTHER||Hazard Ratio (HR)|2.44|||<|0.01|TWO_SIDED||||||Regression, Cox|||||||<0.01
72609648|NCT00721799|144747913|OTHER||C-statistic|0.74||||0.02|TWO_SIDED||||||Regression, Cox|||||||0.02
72609649|NCT00721799|144747914|OTHER||Hazard Ratio (HR)|1.12||||0.73|TWO_SIDED||||||Regression, Cox|||||||0.73
72418034|NCT01212770|144346342|SUPERIORITY||LS Mean Difference|-0.48||||0.0001|TWO_SIDED|95.0|-0.72|-0.24|||ANCOVA|Based on an ANCOVA model with treatment group, baseline DMARD use and ≥ 3% BSA psoriasis involvement as factors and the baseline value as a covariate.||||-0.24|-0.72|0.0001
72418035|NCT01212770|144346342|SUPERIORITY||LS Mean Difference|-0.3||||0.0147|TWO_SIDED|95.0|-0.54|-0.06|||ANCOVA|Based on an ANCOVA model with treatment group, baseline DMARD use and ≥ 3% BSA psoriasis involvement as factors and the baseline value as a covariate.||||-0.06|-0.54|0.0147
72418036|NCT01212770|144346343|SUPERIORITY||LS Mean Difference|2.44||||0.0078|TWO_SIDED|95.0|0.64|4.24|||ANCOVA|Based on an ANCOVA model with treatment group, baseline DMARD use and ≥ 3% BSA psoriasis involvement as factors and the baseline value as a covariate.||||4.24|0.64|0.0078
72418037|NCT01212770|144346343|SUPERIORITY||LS Mean Difference|1.19||||0.1936|TWO_SIDED|95.0|-0.61|2.98|||ANCOVA|Based on an ANCOVA model with treatment group, baseline DMARD use and ≥ 3% BSA psoriasis involvement as factors and the baseline value as a covariate.||||2.98|-0.61|0.1936
72609650|NCT00721799|144747914|OTHER||C-statistic|0.52||||0.88|TWO_SIDED||||||Regression, Cox|||||||0.88
72609651|NCT00721799|144747915|OTHER||Hazard Ratio (HR)|1.11||||0.78|TWO_SIDED||||||Regression, Cox|||||||0.78
72418038|NCT01212770|144346344|SUPERIORITY||Adjusted Difference|2.1||||0.7585|TWO_SIDED|95.0|-10.9|15.0|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use and involvement of \>= 3% BSA with psoriasis at baseline.|Adjusted difference is the weighted average of the treatment differences across 4 strata of baseline DMARD use by ≥ 3% BSA psoriasis involvement at baseline with the CMH weights. The 95% CI is based on a normal approximation to the weighted average.|||15.0|-10.9|0.7585
72418039|NCT01212770|144346344|SUPERIORITY||Adjusted Difference|-3.9||||0.5808|TWO_SIDED|95.0|-17.4|9.7|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use involvement of \>= 3% BSA with psoriasis at baseline.|Adjusted difference is the weighted average of the treatment differences across 4 strata of baseline DMARD use by ≥ 3% BSA psoriasis involvement at baseline with the CMH weights. The 95% CI is based on a normal approximation to the weighted average.|||9.7|-17.4|0.5808
72609652|NCT00721799|144747915|OTHER||C-statistic|0.45||||0.66|TWO_SIDED||||||Regression, Cox|||||||0.66
72609653|NCT00721799|144747916|OTHER||Hazard Ratio (HR)|2.25||||0.01|TWO_SIDED||||||Regression, Cox|||||||0.01
72609654|NCT00721799|144747916|OTHER||C-statistic|0.7||||0.05|TWO_SIDED||||||Regression, Cox|||||||0.05
72609655|NCT00721799|144747917|OTHER||Hazard Ratio (HR)|0.83||||0.63|TWO_SIDED||||||Regression, Cox|||||||0.63
72609656|NCT00721799|144747917|OTHER||C-statistic|0.58||||0.46|TWO_SIDED||||||Regression, Cox|||||||0.46
72609657|NCT00721799|144747918|OTHER||Hazard Ratio (HR)|0.81||||0.58|TWO_SIDED||||||Regression, Cox|||||||0.58
72609658|NCT00721799|144747918|OTHER||C-statistic|0.6||||0.36|TWO_SIDED||||||Regression, Cox|||||||0.36
72609659|NCT00721799|144747919|OTHER||Hazard Ratio (HR)|0.94||||0.89|TWO_SIDED||||||Regression, Cox|||||||0.89
72609660|NCT00721799|144747919|OTHER||C-statistic|0.59||||0.42|TWO_SIDED||||||Regression, Cox|||||||0.42
72609661|NCT00721799|144747920|OTHER||Hazard Ratio (HR)|1.29||||0.43|TWO_SIDED||||||Regression, Cox|||||||0.43
72609662|NCT00721799|144747920|OTHER||C-statistic|0.47||||0.8|TWO_SIDED||||||Regression, Cox|||||||0.80
72609663|NCT00721799|144747921|OTHER||Hazard Ratio (HR)|2.01||||0.01|TWO_SIDED||||||Regression, Cox|||||||0.01
72609664|NCT00721799|144747921|OTHER||C-statistic|0.69||||0.07|TWO_SIDED||||||Regression, Cox|||||||0.07
72609665|NCT00721799|144747922|OTHER||Hazard Ratio (HR)|1.58||||0.18|TWO_SIDED||||||Regression, Cox|||||||0.18
72609666|NCT00721799|144747922|OTHER||C-statistic|0.63||||0.25|TWO_SIDED||||||Regression, Cox|||||||0.25
72609667|NCT00721799|144747923|OTHER||Hazard Ratio (HR)|1.49||||0.24|TWO_SIDED||||||Regression, Cox|||||||0.24
72609668|NCT00721799|144747923|OTHER||C-statistic|0.62||||0.27|TWO_SIDED||||||Regression, Cox|||||||0.27
72609669|NCT00721799|144747924|OTHER||Hazard Ratio (HR)|1.0||||0.99|TWO_SIDED||||||Regression, Cox|||||||0.99
72609670|NCT00721799|144747924|OTHER||C-statistic|0.48||||0.84|TWO_SIDED||||||Regression, Cox|||||||0.84
72609671|NCT00721799|144747925|OTHER||Hazard Ratio (HR)|1.3||||0.41|TWO_SIDED||||||Regression, Cox|||||||0.41
72609672|NCT00721799|144747925|OTHER||C-statistic|0.54||||0.69|TWO_SIDED||||||Regression, Cox|||||||0.69
72609673|NCT00721799|144747926|OTHER||Hazard Ratio (HR)|1.56||||0.17|TWO_SIDED||||||Regression, Cox|||||||0.17
72609674|NCT00721799|144747926|OTHER||C-statistic|0.64||||0.18|TWO_SIDED||||||Regression, Cox|||||||0.18
72609675|NCT00721799|144747927|OTHER||Hazard Ratio (HR)|0.42||||0.09|TWO_SIDED||||||Regression, Cox|||||||0.09
72609676|NCT00721799|144747927|OTHER||Hazard Ratio (HR)|0.72||||0.06|TWO_SIDED||||||Regression, Cox|||||||0.06
72609677|NCT00721799|144747928|OTHER||Hazard Ratio (HR)|0.36||||0.06|TWO_SIDED||||||Regression, Cox|||||||0.06
72609678|NCT00721799|144747928|OTHER||C-statistic|0.74||||0.04|TWO_SIDED||||||Regression, Cox|||||||0.04
72609679|NCT00721799|144747929|OTHER||Hazard Ratio (HR)|3.01|||<|0.01|TWO_SIDED||||||Regression, Cox|||||||<0.01
72609680|NCT00721799|144747929|OTHER||C-statistic|0.82|||<|0.01|TWO_SIDED||||||Regression, Cox|||||||<0.01
72609681|NCT00721799|144747930|OTHER||Hazard Ratio (HR)|1.03||||0.92|TWO_SIDED||||||Regression, Cox|||||||0.92
72609682|NCT00721799|144747930|OTHER||C-statistic|0.48||||0.84|TWO_SIDED||||||Regression, Cox|||||||0.84
72609683|NCT00721799|144747931|OTHER||Hazard Ratio (HR)|1.11||||0.76|TWO_SIDED||||||Regression, Cox|||||||0.76
72609684|NCT00721799|144747931|OTHER||C-statistic|0.45||||0.68|TWO_SIDED||||||Regression, Cox|||||||0.68
72609685|NCT00721799|144747932|OTHER||Hazard Ratio (HR)|2.99|||<|0.01|TWO_SIDED||||||Regression, Cox|||||||<0.01
72609686|NCT00721799|144747932|OTHER||C-statistic|0.74||||0.03|TWO_SIDED||||||Regression, Cox|||||||0.03
72609687|NCT00721799|144747933|OTHER||Hazard Ratio (HR)|0.78||||0.55|TWO_SIDED||||||Regression, Cox|||||||0.55
72609688|NCT00721799|144747933|OTHER||C-statistic|0.61||||0.35|TWO_SIDED||||||Regression, Cox|||||||0.35
72609689|NCT00721799|144747934|OTHER||Hazard Ratio (HR)|0.74||||0.48|TWO_SIDED||||||Regression, Cox|||||||0.48
72609690|NCT00721799|144747934|OTHER||C-statistic|0.63||||0.28|TWO_SIDED||||||Regression, Cox|||||||0.28
72609691|NCT00721799|144747935|OTHER||Hazard Ratio (HR)|0.81||||0.67|TWO_SIDED||||||Regression, Cox|||||||0.67
72609692|NCT00721799|144747935|OTHER||C-statistic|0.71||||0.11|TWO_SIDED||||||Regression, Cox|||||||0.11
72609693|NCT00721799|144747936|OTHER||Hazard Ratio (HR)|1.32||||0.4|TWO_SIDED||||||Regression, Cox|||||||0.40
72609694|NCT00721799|144747936|OTHER||C-statistic|0.48||||0.88|TWO_SIDED||||||Regression, Cox|||||||0.88
72609695|NCT00721799|144747937|OTHER||Hazard Ratio (HR)|2.39|||<|0.01|TWO_SIDED||||||Regression, Cox|||||||<0.01
72609696|NCT00721799|144747937|OTHER||C-statistic|0.74||||0.03|TWO_SIDED||||||Regression, Cox|||||||0.03
72609697|NCT00721799|144747938|OTHER||Hazard Ratio (HR)|1.51||||0.26|TWO_SIDED||||||Regression, Cox|||||||0.26
72609698|NCT00721799|144747938|OTHER||C-statistic|0.59||||0.46|TWO_SIDED||||||Regression, Cox|||||||0.46
72609699|NCT00721799|144747939|OTHER||Hazard Ratio (HR)|1.38||||0.37|TWO_SIDED||||||Regression, Cox|||||||0.37
72609700|NCT00721799|144747939|OTHER||C-statistic|0.59||||0.46|TWO_SIDED||||||Regression, Cox|||||||0.46
72609701|NCT00721799|144747940|OTHER||Hazard Ratio (HR)|1.05||||0.9|TWO_SIDED||||||Regression, Cox|||||||0.90
72609702|NCT00721799|144747940|OTHER||C-statistic|0.52||||0.87|TWO_SIDED||||||Regression, Cox|||||||0.87
72609703|NCT00721799|144747941|OTHER||Hazard Ratio (HR)|1.35||||0.36|TWO_SIDED||||||Regression, Cox|||||||0.36
72609704|NCT00721799|144747941|OTHER||C-statistic|0.56||||0.63|TWO_SIDED||||||Regression, Cox|||||||0.63
72609705|NCT00721799|144747942|OTHER||Hazard Ratio (HR)|1.56||||0.2|TWO_SIDED||||||Regression, Cox|||||||0.20
72609706|NCT00721799|144747942|OTHER||C-statistic|0.63||||0.24|TWO_SIDED||||||Regression, Cox|||||||0.24
72609707|NCT02873689|144747944|SUPERIORITY|||||||0.057|||||||Wilcoxon rank-sum test|||||||0.057
72609708|NCT02873689|144747945|SUPERIORITY|||||||0.268|||||||Wilcoxon rank-sum test|||||||0.268
72609709|NCT02997163|144747969|SUPERIORITY||Percent Ratio of Geometric Means|112.2|||||TWO_SIDED|90.0|80.06|157.26||||||||157.26|80.06|
72609710|NCT02997163|144747969|SUPERIORITY||Percent Ratio of Geometric Means|142.98|||||TWO_SIDED|90.0|103.03|198.42||||||||198.42|103.03|
72609711|NCT02997163|144747969|SUPERIORITY||Percent Ratio of Geometric Means|263.32|||||TWO_SIDED|90.0|187.88|369.06||||||||369.06|187.88|
72609712|NCT02997163|144747970|SUPERIORITY||Percent Ratio of Geometric Means|111.13|||||TWO_SIDED|90.0|74.4|166.01||||||||166.01|74.40|
72609713|NCT02997163|144747970|SUPERIORITY||Percent Ratio of Geometric Means|131.57|||||TWO_SIDED|90.0|89.12|194.25||||||||194.25|89.12|
72609714|NCT02997163|144747970|SUPERIORITY||Percent Ratio of Geometric Means|189.32|||||TWO_SIDED|90.0|126.74|282.8||||||||282.80|126.74|
72609715|NCT02997163|144747971|SUPERIORITY||Percent Ratio of Geometric Means|118.58|||||TWO_SIDED|90.0|83.85|167.7||||||||167.70|83.85|
72609716|NCT02997163|144747971|SUPERIORITY||Percent Ratio of Geometric Means|139.34|||||TWO_SIDED|90.0|99.53|195.06||||||||195.06|99.53|
72609717|NCT02997163|144747971|SUPERIORITY||Percent Ratio of Geometric Means|286.61|||||TWO_SIDED|90.0|202.66|405.33||||||||405.33|202.66|
72609718|NCT02997163|144747972|SUPERIORITY||Percent Ratio of Geometric Means|117.45|||||TWO_SIDED|90.0|79.74|172.99||||||||172.99|79.74|
72609719|NCT02997163|144747972|SUPERIORITY||Percent Ratio of Geometric Means|128.22|||||TWO_SIDED|90.0|88.05|186.72||||||||186.72|88.05|
72609720|NCT02997163|144747972|SUPERIORITY||Percent Ratio of Geometric Means|206.07|||||TWO_SIDED|90.0|139.91|303.51||||||||303.51|139.91|
72609721|NCT02470741|144748008|SUPERIORITY||Mean Difference (Net)|-11.85||||0.24|TWO_SIDED|95.0|-32.92|9.23|||Mixed Models Analysis|Repeated measures mixed models, with unstructured co-variance matrix.|Model generated LS Mean Differences|Null hypotheses: Letrozole is not associated with an improvement in the UFSQOL Overall Score.||9.23|-32.92|0.24
72609722|NCT01677286|144748031|OTHER|P-values and confidence intervals are not adjusted for multiple testing|Mean outcome change|171.0||||0.035|TWO_SIDED|95.0|14.1|328.0|||Mixed Models Analysis|degrees of freedom = 12||BNP pg/mL, baseline versus end study values||328|14.1|0.035
72609723|NCT01677286|144748032|OTHER|P-values and confidence intervals are not adjusted for multiple testing|Mean outcome change|0.0072||||0.34|TWO_SIDED|95.0|-0.009|0.0234|||Mixed Models Analysis|degrees of freedom = 12||Troponin I ng/mL, baseline versus end study levels.||0.0234|-0.009|0.340
72325903|NCT04046939|144175263|SUPERIORITY||Mean Difference (Final Values)|-0.264||||0.3059|TWO_SIDED|95.0|-0.772|0.245||For secondary endpoints which were not key secondary endpoints, no adjustment for multiple testing was used and p \<0.05 was used for statistical significance.|Mixed Models Analysis||Estimate is the difference of the 150 mg BID dexpramipexole group compared to the placebo group in change in ACQ-6 score from Baseline to Week 12 (end of primary treatment period). A negative value indicates improvement of asthma symptoms.|The 150 mg BID dexpramipexole group was compared to placebo using a mixed effects model repeated-measures (MMRM).||0.245|-0.772|0.3059
72325904|NCT04046939|144175263|SUPERIORITY||Mean Difference (Final Values)|-0.0457||||0.8642|TWO_SIDED|95.0|-0.575|0.484||For secondary endpoints which were not key secondary endpoints, no adjustment for multiple testing was used and p \<0.05 was used for statistical significance.|Mixed Models Analysis||Estimate is the difference of the 75 mg BID dexpramipexole group compared to the placebo group in change in ACQ-6 score from Baseline to Week 12 (end of primary treatment period). A negative value indicates improvement of asthma symptoms.|The 75 mg BID dexpramipexole group was compared to placebo using a mixed effects model repeated-measures (MMRM).||0.484|-0.575|0.8642
72325905|NCT04046939|144175263|SUPERIORITY||Mean Difference (Final Values)|-0.0276||||0.9182|TWO_SIDED|95.0|-0.56|0.505||For secondary endpoints which were not key secondary endpoints, no adjustment for multiple testing was used and p \<0.05 was used for statistical significance.|Mixed Models Analysis||Estimate is the difference of the 37.5 mg BID dexpramipexole group compared to the placebo group in change in ACQ-6 score from Baseline to Week 12 (end of primary treatment period). A negative value indicates improvement of asthma symptoms.|The 37.5 mg BID dexpramipexole group was compared to placebo using a mixed effects model repeated-measures (MMRM).||0.505|-0.560|0.9182
72325906|NCT04046939|144175264|SUPERIORITY||Mean Difference (Final Values)|0.181||||0.0716|TWO_SIDED|95.0|-0.0163|0.378||For secondary endpoints which were not key secondary endpoints, no adjustment for multiple testing was used and p \<0.05 was used for statistical significance.|ANCOVA||Estimate the difference of the 150 mg BID Dexpramipexole group from placebo in change in post-bronchodilator FEV1 from Baseline to Week 12 (end of primary treatment period) in liters. A positive value indicates improvement in lung function.|An ANCOVA analysis was performed comparing the 150 mg BID dexpramipexole group to placebo.||0.378|-0.0163|0.0716
72325907|NCT04046939|144175264|SUPERIORITY||Mean Difference (Final Values)|0.00474||||0.9619|TWO_SIDED|95.0|-0.192|0.202||For secondary endpoints which were not key secondary endpoints, no adjustment for multiple testing was used and p \<0.05 was used for statistical significance.|ANCOVA||Estimate the difference of the 75 mg BID Dexpramipexole group from placebo in change in post-bronchodilator FEV1 from Baseline to Week 12 (end of primary treatment period) in liters. A positive value indicates improvement in lung function.|An ANCOVA analysis was performed comparing the 75 mg BID dexpramipexole group to placebo.||0.202|-0.192|0.9619
72325908|NCT04046939|144175264|SUPERIORITY||Median Difference (Final Values)|0.0987||||0.3368|TWO_SIDED|95.0|-0.105|0.302||For secondary endpoints which were not key secondary endpoints, no adjustment for multiple testing was used and p \<0.05 was used for statistical significance.|ANCOVA||Estimate the difference of the 37.5 mg BID Dexpramipexole group from placebo in change in post-bronchodilator FEV1 from Baseline to Week 12 (end of primary treatment period) in liters. A positive value indicates improvement in lung function.|An ANCOVA analysis was performed comparing the 37.5 mg BID dexpramipexole group to placebo.||0.302|-0.105|0.3368
72325909|NCT04046939|144175265|SUPERIORITY||Mean Difference (Final Values)|0.208||||0.4512|TWO_SIDED|95.0|-0.338|0.755||For secondary endpoints which were not key secondary endpoints, no adjustment for multiple testing was used and p \<0.05 was used for statistical significance.|ANCOVA||Estimate the difference in the 150 mg BID dexpramipexole group from the placebo group in the change in AQLQ score from Baseline to Week 12 (end of primary treatment period). A positive value indicates improvement of asthma symptoms.|An ANCOVA analysis was performed comparing the 150 mg BID dexpramipexole group to placebo.||0.755|-0.338|0.4512
72325910|NCT04046939|144175265|SUPERIORITY||Mean Difference (Final Values)|-0.0642||||0.8214|TWO_SIDED|95.0|-0.627|0.499||For secondary endpoints which were not key secondary endpoints, no adjustment for multiple testing was used and p \<0.05 was used for statistical significance.|ANCOVA||Estimate the difference in the 75 mg BID dexpramipexole group from the placebo group in the change in AQLQ score from Baseline to Week 12 (end of primary treatment period). A positive value indicates improvement of asthma symptoms.|An ANCOVA analysis was performed comparing the 75 mg BID dexpramipexole group to placebo.||0.499|-0.627|0.8214
72325911|NCT04046939|144175265|SUPERIORITY||Mean Difference (Final Values)|0.154||||0.5894|TWO_SIDED|95.0|-0.411|0.72||For secondary endpoints which were not key secondary endpoints, no adjustment for multiple testing was used and p \<0.05 was used for statistical significance.|ANCOVA||Estimate the difference in the 37.5 mg BID dexpramipexole group from the placebo group in the change in AQLQ score from Baseline to Week 12 (end of primary treatment period). A positive value indicates improvement of asthma symptoms.|An ANCOVA analysis was performed comparing the 37.5 mg BID dexpramipexole group to placebo.||0.720|-0.411|0.5894
72325912|NCT04046939|144175271|SUPERIORITY|||||||0.0196||||||No adjustment for multiple testing of exploratory endpoints was used.|Wilcoxon (Mann-Whitney)|||The 150 mg BID dexpramipexole group was compared to placebo at Week 12 using a Wilcoxon rank sum test.||||0.0196
72325913|NCT04046939|144175271|SUPERIORITY|||||||0.0207||||||No adjustment for multiple testing of exploratory endpoints was used.|Wilcoxon (Mann-Whitney)|||The 75mg BID dexpramipexole group was compared to placebo at Week 12 using a Wilcoxon rank sum test.||||0.0207
72325914|NCT04046939|144175271|SUPERIORITY|||||||0.5399||||||No adjustment for multiple testing of exploratory endpoints was used.|Wilcoxon (Mann-Whitney)|||The 37.5 mg BID dexpramipexole group was compared to placebo at Week 12 using a Wilcoxon rank sum test.||||0.5399
72418040|NCT01212770|144346345|SUPERIORITY||Adjusted Difference|12.0||||0.1303|TWO_SIDED|95.0|-3.1|27.0|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD useinvolvement of \>= 3% BSA with psoriasis at baseline..|Adjusted difference is the weighted average of the treatment differences across 4 strata of baseline DMARD use by ≥ 3% BSA psoriasis involvement at baseline with the CMH weights. The 95% CI is based on a normal approximation to the weighted average.|||27.0|-3.1|0.1303
72609724|NCT01677286|144748033|OTHER|P-values and confidence intervals are not adjusted for multiple testing|Change in outcome measure|-7.39||||0.017|TWO_SIDED|95.0|-13.12|-1.67|||Mixed Models Analysis|degrees of freedom = 10||Creatinine clearance, baseline versus end study levels.||-1.67|-13.12|0.017
72325915|NCT04046939|144175272|SUPERIORITY||Mean Difference (Final Values)|-0.0233||||0.0084|TWO_SIDED|95.0|-0.0405|-0.00613||No adjustment for multiple testing of exploratory endpoints was used.|Mixed Models Analysis||Estimate is the difference of the 150 mg BID group from the placebo group in the change absolute basophil count (automated differential) from Baseline to Week 12 (end of primary treatment period). A negative value represents fewer basophils.|The 150 mg BID dexpramipexole group was compared to placebo using a mixed effects model repeated-measures (MMRM) with terms for baseline, GINA treatment step, treatment, visit, treatment by visit interaction, and baseline by visit interaction as fixed effects, and subject as a random effect. An unstructured covariance matrix was used. The response variable was the post-baseline value minus the baseline value.||-0.00613|-0.0405|0.0084
72325916|NCT04046939|144175272|SUPERIORITY||Mean Difference (Final Values)|-0.0206||||0.0237|TWO_SIDED|95.0|-0.0384|-0.00281||No adjustment for multiple testing of exploratory endpoints was used.|Mixed Models Analysis||Estimate is the difference of the 75 mg BID group from the placebo group in the change absolute basophil count (automated differential) from Baseline to Week 12 (end of primary treatment period). A negative value represents fewer basophils.|The 75 mg BID dexpramipexole group was compared to placebo using a mixed effects model repeated-measures (MMRM) with terms for baseline, GINA treatment step, treatment, visit, treatment by visit interaction, and baseline by visit interaction as fixed effects, and subject as a random effect. An unstructured covariance matrix was used. The response variable was the post-baseline value minus the baseline value.||-0.00281|-0.0384|0.0237
72325917|NCT04046939|144175272|SUPERIORITY||Mean Difference (Final Values)|-0.00215||||0.814|TWO_SIDED|95.0|-0.0203|0.016||No adjustment for multiple testing of exploratory endpoints was used.|Mixed Models Analysis||Estimate is the difference of the 37.5 mg BID group from the placebo group in the change absolute basophil count (automated differential) from Baseline to Week 12 (end of primary treatment period). A negative value represents fewer basophils.|The 37.5 mg BID dexpramipexole group was compared to placebo using a mixed effects model repeated-measures (MMRM) with terms for baseline, GINA treatment step, treatment, visit, treatment by visit interaction, and baseline by visit interaction as fixed effects, and subject as a random effect. An unstructured covariance matrix was used. The response variable was the post-baseline value minus the baseline value.||0.0160|-0.0203|0.8140
72325918|NCT04046939|144175273|SUPERIORITY||Mean Difference (Final Values)|-8.24||||0.1886|TWO_SIDED|95.0|-20.6|4.13||No adjustment for multiple testing of exploratory endpoints was used.|Mixed Models Analysis||Estimate is the difference of the 150 mg BID group from the placebo group in the change in FeNO from Baseline to Week 12 in liters. In eosinophilic asthma, a lower FeNO indicates less eosinophilic inflammation of the airway than a higher value.|The 150 mg BID dexpramipexole group was compared to placebo using a mixed effects model repeated-measures (MMRM) with terms for baseline, GINA treatment step, treatment, visit, treatment by visit interaction, and baseline by visit interaction as fixed effects, and subject as a random effect. An unstructured covariance matrix was used. The response variable was the post-baseline value minus the baseline value.||4.13|-20.6|0.1886
72325919|NCT04046939|144175273|SUPERIORITY||Mean Difference (Final Values)|-6.53||||0.3061|TWO_SIDED|95.0|-19.1|6.08||No adjustment for multiple testing of exploratory endpoints was used.|Mixed Models Analysis||Estimate is the difference of the 75 mg BID group from the placebo group in the change in FeNO from Baseline to Week 12 in liters. In eosinophilic asthma, a lower FeNO indicates less eosinophilic inflammation of the airway than a higher value.|The 75mg BID dexpramipexole group was compared to placebo using a mixed effects model repeated-measures (MMRM) with terms for baseline, GINA treatment step, treatment, visit, treatment by visit interaction, and baseline by visit interaction as fixed effects, and subject as a random effect. An unstructured covariance matrix was used. The response variable was the post-baseline value minus the baseline value.||6.08|-19.1|0.3061
72325920|NCT04046939|144175273|SUPERIORITY||Mean Difference (Final Values)|-10.2||||0.1294|TWO_SIDED|95.0|-23.4|3.04||No adjustment for multiple testing of exploratory endpoints was used.|Mixed Models Analysis||Estimate is the difference of the 37.5 mg BID group from the placebo group in the change in FeNO from Baseline to Week 12 in liters. In eosinophilic asthma, a lower FeNO indicates less eosinophilic inflammation of the airway than a higher value.|The 37.5 mg BID dexpramipexole group was compared to placebo using a mixed effects model repeated-measures (MMRM) with terms for baseline, GINA treatment step, treatment, visit, treatment by visit interaction, and baseline by visit interaction as fixed effects, and subject as a random effect. An unstructured covariance matrix was used. The response variable was the post-baseline value minus the baseline value.||3.04|-23.4|0.1294
72325921|NCT00806260|144175278|NON_INFERIORITY_OR_EQUIVALENCE|step down test|Mean Difference (Final Values)|0.33|STANDARD_ERROR_OF_MEAN|0.07|||ONE_SIDED|90.0|0.21||||ANCOVA|||at alcohol level 0.10%|||0.21|
72325922|NCT00806260|144175278|NON_INFERIORITY_OR_EQUIVALENCE|step down test|Mean Difference (Final Values)|0.21|STANDARD_ERROR_OF_MEAN|0.05|||ONE_SIDED|90.0|0.12||||ANCOVA|||at alcohol level 0.07%|||0.12|
72325923|NCT00806260|144175278|NON_INFERIORITY_OR_EQUIVALENCE|step-down test|Mean Difference (Final Values)|0.06|STANDARD_ERROR_OF_MEAN|0.06|||ONE_SIDED|90.0|-0.03||||ANCOVA|||at alcohol level 0.04%|||-0.03|
72325924|NCT00806260|144175279|NON_INFERIORITY_OR_EQUIVALENCE|non-inferiority|Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.06|||TWO_SIDED|95.0|-0.17|0.07|||ANCOVA|||at 2 hr timepoint||0.07|-0.17|
72325925|NCT00806260|144175279|NON_INFERIORITY_OR_EQUIVALENCE|non inferiority test|Mean Difference (Final Values)|-0.07|STANDARD_ERROR_OF_MEAN|0.05|||TWO_SIDED|95.0|-0.18|0.04|||ANCOVA|||at 6 hr timepoint||0.04|-0.18|
72325926|NCT00806260|144175279|NON_INFERIORITY_OR_EQUIVALENCE|non inferiority|Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.03|||TWO_SIDED|95.0|-0.08|0.06|||ANCOVA|||at 2 hr timepoint||0.06|-0.08|
72325927|NCT00806260|144175279|NON_INFERIORITY_OR_EQUIVALENCE|non inferiority|Mean Difference (Final Values)|-0.04|STANDARD_ERROR_OF_MEAN|0.04|||TWO_SIDED|95.0|-0.13|0.05|||ANCOVA|||at 6 hr timepoint||0.05|-0.13|
72609725|NCT01677286|144748034|OTHER|P-values and confidence intervals are not adjusted for multiple testing|Change in outcome measure|0.091||||0.603|TWO_SIDED|95.0|-0.285|0.466|||Mixed Models Analysis|degrees of freedom = 10||Proteinuria (g/24 hours), baseline versus end study levels.||0.466|-0.285|0.603
72609726|NCT04539275|144748041|SUPERIORITY||Risk Difference (RD)|-0.01||||1|TWO_SIDED|95.0|-0.15|0.14|||Fisher Exact|||||0.14|-0.15|1.00
72609727|NCT04539275|144748042|SUPERIORITY||Improvement Rate Ratio|1.08||||0.749|TWO_SIDED|95.0|0.65|1.78|||Log Rank|||||1.78|0.65|0.749
72609728|NCT04539275|144748043|SUPERIORITY||Hazard Ratio (HR)|0.95||||0.943|TWO_SIDED|95.0|0.21|4.23|||Log Rank|||||4.23|0.21|0.943
72609729|NCT04539275|144748044|SUPERIORITY||Risk Difference (RD)|-0.08||||0.4014|TWO_SIDED|95.0|-0.25|0.1|||Chi-squared|||||0.10|-0.25|0.4014
72418041|NCT01212770|144346345|SUPERIORITY||Adjusted Difference|7.5||||0.361|TWO_SIDED|95.0|-8.3|23.2|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use involvement of \>= 3% BSA with psoriasis at baseline.|Adjusted difference is the weighted average of the treatment differences across 4 strata of baseline DMARD use by ≥ 3% BSA psoriasis involvement at baseline with the CMH weights. The 95% CI is based on a normal approximation to the weighted average.|||23.2|-8.3|0.3610
72418042|NCT01212770|144346346|SUPERIORITY||Adjusted Difference|22.5|||<|0.0001|TWO_SIDED|95.0|12.4|32.6|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use involvement of \>= 3% BSA with psoriasis at baseline.|Adjusted difference is the weighted average of the treatment differences across 4 strata of baseline DMARD use by ≥ 3% BSA psoriasis involvement at baseline with the CMH weights. The 95% CI is based on a normal approximation to the weighted average.|||32.6|12.4|< 0.0001
72609730|NCT04539275|144748045|SUPERIORITY||Hazard Ratio (HR)|0.59||||0.3762|TWO_SIDED|95.0|0.18|1.96|||Log Rank|||||1.96|0.18|0.3762
72609731|NCT04539275|144748046|SUPERIORITY||Risk Difference (RD)|-0.04||||0.6867|TWO_SIDED|95.0|-0.17|0.09|||Fisher Exact|||||0.09|-0.17|0.6867
72609732|NCT04539275|144748047|SUPERIORITY||Improvement Rate Ratio|1.11||||0.6494|TWO_SIDED|95.0|0.68|1.83|||Log Rank|||||1.83|0.68|0.6494
72609733|NCT04539275|144748048|SUPERIORITY||Improvement Rate Ratio|0.98||||0.9338|TWO_SIDED|95.0|0.59|1.63|||Log Rank|||||1.63|0.59|0.9338
72609734|NCT04539275|144748052|SUPERIORITY||Improvement Rate Ratio|1.14||||0.5682|TWO_SIDED|95.0|0.7|1.86|||Log Rank|||||1.86|0.70|0.5682
72609735|NCT04539275|144748054|SUPERIORITY||Median Difference (Final Values)|0.0||||0.8642|TWO_SIDED|95.0|-2.3|2.3|||Wilcoxon (Mann-Whitney)|||||2.3|-2.3|0.8642
72609736|NCT02419807|144748082|EQUIVALENCE|Equivalence is defined as the difference in the proportions of nodes flagged between the Tc and ICG methods falling within an interval (-δ, +δ), where δ is taken to be 5%.|Mean Difference (Final Values)|0.09|||||TWO_SIDED|95.0|0.036|0.151||||||||0.151|0.036|
72609737|NCT02932943|144748123|SUPERIORITY||Least Squares Mean Difference|0.3||||0.6482|TWO_SIDED|95.0|-1.07|1.72|||Mixed Model Repeated Measures (MMRM)|||||1.72|-1.07|0.6482
72609738|NCT02932943|144748124|SUPERIORITY||Least Squares Mean Difference|-0.4||||0.559|TWO_SIDED|95.0|-1.61|0.87|||Mixed Model Repeated Measures (MMRM)|||||0.87|-1.61|0.5590
72609739|NCT02932943|144748125|SUPERIORITY||Least Squares Mean Difference|0.2||||0.8131|TWO_SIDED|95.0|-1.53|1.95|||Mixed Model Repeated Measures (MMRM)|||||1.95|-1.53|0.8131
72609740|NCT02932943|144748126|SUPERIORITY||Least Squares Mean Difference|-0.4||||0.6108|TWO_SIDED|95.0|-2.05|1.21|||Mixed Model Repeated Measures (MMRM)|||||1.21|-2.05|0.6108
72609741|NCT01663623|144748132|OTHER||Hazard Ratio (HR)|1.07||||0.884|TWO_SIDED|95.0|0.44|2.59||Cox proportional Hazards (Wald Chi Square)|Cox Proportional Hazards model|Analysis was adjusted for ANCA type, disease stage at induction and induction regimen|Analysis performed using a Cox Proportional Hazards model with covariates treatment group, Actual ANCA type, Actual disease stage at induction and Actual induction regimen.|||2.59|0.44|0.884
72609742|NCT02265510|144748143|OTHER|Descriptive Statistics|||||||||||||||||The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.|||
72609743|NCT02265510|144748144|OTHER||||||||||||||||||Confidence Intervals for ORR were calculated based on the exact method for binomial distributions. There were no comparison between treatment groups.|||
72609744|NCT02265510|144748145|OTHER||||||||||||||||||Confidence Intervals for response were calculated based on the exact method for binomial distributions. There were no comparison between treatment groups.|||
72609745|NCT02265510|144748146|OTHER||||||||||||||||||The analysis of the endpoint was descriptive i.e. no statistical hypothesis test was performed.|||
72609746|NCT02265510|144748147|OTHER||||||||||||||||||The analysis of the endpoint was descriptive i.e. no statistical hypothesis test was performed.|||
72609747|NCT02265510|144748148|OTHER||||||||||||||||||The analysis of the endpoint was descriptive i.e. no statistical hypothesis test was performed.|||
72609748|NCT02265510|144748149|OTHER||||||||||||||||||The analysis of the endpoint was descriptive i.e. no statistical hypothesis test was performed.|||
72609749|NCT02265510|144748150|OTHER||||||||||||||||||The analysis of the endpoint was descriptive i.e. no statistical hypothesis test was performed.|||
72609750|NCT02265510|144748151|OTHER||||||||||||||||||The analysis of the endpoint was descriptive i.e. no statistical hypothesis test was performed.|||
72609751|NCT02265510|144748152|OTHER||||||||||||||||||The analysis of the endpoint was descriptive i.e. no statistical hypothesis test was performed.|||
72609752|NCT02265510|144748153|OTHER||||||||||||||||||The analysis of the endpoint was descriptive i.e. no statistical hypothesis test was performed.|||
72609753|NCT01004614|144748166|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the two formulations was concluded if the 90% confidence intervals for the ratio of adjusted geometric means for both AUCt and Cmax fell wholly within (80%, 125%).|ratios of adjusted geometric mean|98.61|||||TWO_SIDED|90.0|93.09|104.46|||||Parameter estimate = ratio (%) (test/reference) of adjusted geometric means.|Natural log transformed AUCt was analyzed using a mixed effects model with sequence, period and formulation as fixed effects and subject within sequence as a random effect. Adjusted mean difference (test - reference) and 90% CI was obtained from the model and exponentiated to provide estimates of the ratio of adjusted geometric mean and 90% CI for the ratio. Alternative hypothesis of bioequivalence: (H1: θL \<=µT - µR \<=θU); null hypothesis of inequivalence: (Ho: µT - µR \<θL or µT - µR \>θU).||104.46|93.09|
72609754|NCT01004614|144748166|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the two formulations was concluded if the 90% confidence intervals for the ratio of adjusted geometric means for both AUCt and Cmax fell wholly within (80%, 125%).|ratios of adjusted geometric mean|101.29|||||TWO_SIDED|90.0|97.28|105.45|||||Parameter estimate = ratio (%) (test/reference) of adjusted geometric means.|Natural log transformed AUCt was analyzed using a mixed effects model with sequence, period and formulation as fixed effects and subject within sequence as a random effect. Adjusted mean difference (test - reference) and 90% CI was obtained from the model and exponentiated to provide estimates of the ratio of adjusted geometric mean and 90% CI for the ratio. Alternative hypothesis of bioequivalence: (H1: θL \<=µT - µR \<=θU); null hypothesis of inequivalence: (Ho: µT - µR \<θL or µT - µR \>θU).||105.45|97.28|
72418043|NCT01212770|144346346|SUPERIORITY||Adjusted Difference|11.0||||0.0309|TWO_SIDED|95.0|1.2|20.9|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use involvement of \>= 3% BSA with psoriasis at baseline.|Adjusted difference is the weighted average of the treatment differences across 4 strata of baseline DMARD use by ≥ 3% BSA psoriasis involvement at baseline with the CMH weights. The 95% CI is based on a normal approximation to the weighted average.|||20.9|1.2|0.0309
72418044|NCT01212770|144346347|SUPERIORITY||Adjusted Difference|3.8||||0.5731|TWO_SIDED|95.0|-9.1|16.7|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use involvement of \>= 3% BSA with psoriasis at baseline.|Adjusted difference is the weighted average of the treatment differences across 4 strata of baseline DMARD use by ≥ 3% BSA psoriasis involvement at baseline with the CMH weights. The 95% CI is based on a normal approximation to the weighted average.|||16.7|-9.1|0.5731
72418045|NCT01212770|144346347|SUPERIORITY||Adjusted Difference|1.0||||0.8876|TWO_SIDED|95.0|-12.6|14.6|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use involvement of \>= 3% BSA with psoriasis at baseline.|Adjusted difference is the weighted average of the treatment differences across 4 strata of baseline DMARD use by ≥ 3% BSA psoriasis involvement at baseline with the CMH weights. The 95% CI is based on a normal approximation to the weighted average.|||14.6|-12.6|0.8876
72418046|NCT01212770|144346348|SUPERIORITY||Adjusted Difference|12.2||||0.1172|TWO_SIDED|95.0|-2.5|26.9|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use involvement of \>= 3% BSA with psoriasis at baseline.|Adjusted difference is the weighted average of the treatment differences across 4 strata of baseline DMARD use by ≥ 3% BSA psoriasis involvement at baseline with the CMH weights. The 95% CI is based on a normal approximation to the weighted average.|||26.9|-2.5|0.1172
72418047|NCT01212770|144346348|SUPERIORITY||Adjusted Difference|7.2||||0.3695|TWO_SIDED|95.0|-8.2|22.6|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use involvement of \>= 3% BSA with psoriasis at baseline.|Adjusted difference is the weighted average of the treatment differences across 4 strata of baseline DMARD use by ≥ 3% BSA psoriasis involvement at baseline with the CMH weights. The 95% CI is based on a normal approximation to the weighted average.|||22.6|-8.2|0.3695
72418048|NCT01212770|144346349|SUPERIORITY||Adjusted Difference|22.5|||<|0.0001|TWO_SIDED|95.0|13.0|32.1|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use involvement of \>= 3% BSA with psoriasis at baseline.|Adjusted difference is the weighted average of the treatment differences across 4 strata of baseline DMARD use by ≥ 3% BSA psoriasis involvement at baseline with the CMH weights. The 95% CI is based on a normal approximation to the weighted average.|||32.1|13.0|< 0.0001
72418049|NCT01212770|144346349|SUPERIORITY||Adjusted Difference|11.7||||0.0123|TWO_SIDED|95.0|2.7|20.7|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use involvement of \>= 3% BSA with psoriasis at baseline.|Adjusted difference is the weighted average of the treatment differences across 4 strata of baseline DMARD use by ≥ 3% BSA psoriasis involvement at baseline with the CMH weights. The 95% CI is based on a normal approximation to the weighted average.|||20.7|2.7|0.0123
72418050|NCT01212770|144346350|SUPERIORITY||Adjusted Difference|6.8||||0.052|TWO_SIDED|95.0|0.0|13.5|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use involvement of \>= 3% BSA with psoriasis at baseline.|Adjusted difference is the weighted average of the treatment differences across 4 strata of baseline DMARD use by ≥ 3% BSA psoriasis involvement at baseline with the CMH weights. The 95% CI is based on a normal approximation to the weighted average.|||13.5|0.0|0.0520
72418051|NCT01212770|144346350|SUPERIORITY||Adjusted Difference|4.2||||0.2052|TWO_SIDED|95.0|-2.2|10.6|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use involvement of \>= 3% BSA with psoriasis at baseline.|Adjusted difference is the weighted average of the treatment differences across 4 strata of baseline DMARD use by ≥ 3% BSA psoriasis involvement at baseline with the CMH weights. The 95% CI is based on a normal approximation to the weighted average.|||10.6|-2.2|0.2052
72418052|NCT01212770|144346351|SUPERIORITY||Adjusted Difference|1.2||||0.5154|TWO_SIDED|95.0|-2.4|4.8|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use involvement of \>= 3% BSA with psoriasis at baseline.|Adjusted difference is the weighted average of the treatment differences across 4 strata of baseline DMARD use by ≥ 3% BSA psoriasis involvement at baseline with the CMH weights. The 95% CI is based on a normal approximation to the weighted average.|||4.8|-2.4|0.5154
72418053|NCT01212770|144346351|SUPERIORITY||Adjusted Difference|2.3||||0.2527|TWO_SIDED|95.0|-1.5|6.2|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use involvement of \>= 3% BSA with psoriasis at baseline.|Adjusted difference is the weighted average of the treatment differences across 4 strata of baseline DMARD use by ≥ 3% BSA psoriasis involvement at baseline with the CMH weights. The 95% CI is based on a normal approximation to the weighted average.|||6.2|-1.5|0.2527
72418054|NCT01212770|144346352|SUPERIORITY||Adjusted Difference|8.3||||0.018|TWO_SIDED|95.0|1.6|15.1|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use involvement of \>= 3% BSA with psoriasis at baseline.|Adjusted difference is the weighted average of the treatment differences across 4 strata of baseline DMARD use by ≥ 3% BSA psoriasis involvement at baseline with the CMH weights. The 95% CI is based on a normal approximation to the weighted average.|||15.1|1.6|0.0180
72418055|NCT01212770|144346352|SUPERIORITY||Adjusted Difference|5.8||||0.0807|TWO_SIDED|95.0|-0.6|12.3|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use involvement of \>= 3% BSA with psoriasis at baseline.|Adjusted difference is the weighted average of the treatment differences across 4 strata of baseline DMARD use by ≥ 3% BSA psoriasis involvement at baseline with the CMH weights. The 95% CI is based on a normal approximation to the weighted average.|||12.3|-0.6|0.0807
72418056|NCT01212770|144346353|SUPERIORITY||Adjusted Difference|1.8||||0.423|TWO_SIDED|95.0|-2.6|6.2|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use involvement of \>= 3% BSA with psoriasis at baseline.|Adjusted difference is the weighted average of the treatment differences across 4 strata of baseline DMARD use by ≥ 3% BSA psoriasis involvement at baseline with the CMH weights. The 95% CI is based on a normal approximation to the weighted average.|||6.2|-2.6|0.4230
72418057|NCT01212770|144346353|SUPERIORITY||Adjusted Difference|0.6||||0.787|TWO_SIDED|95.0|-3.5|4.6|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use involvement of \>= 3% BSA with psoriasis at baseline.|Adjusted difference is the weighted average of the treatment differences across 4 strata of baseline DMARD use by ≥ 3% BSA psoriasis involvement at baseline with the CMH weights. The 95% CI is based on a normal approximation to the weighted average.|||4.6|-3.5|0.7870
72418058|NCT01212770|144346354|SUPERIORITY||Adjusted Difference|-4.1||||0.4707|TWO_SIDED|95.0|-14.8|6.5|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use involvement of \>= 3% BSA with psoriasis at baseline.|Adjusted difference is the weighted average of the treatment differences across 4 strata of baseline DMARD use by ≥ 3% BSA psoriasis involvement at baseline with the CMH weights. The 95% CI is based on a normal approximation to the weighted average.|||6.5|-14.8|0.4707
72418059|NCT01212770|144346354|SUPERIORITY||Adjusted Difference|-5.4||||0.3547|TWO_SIDED|95.0|-16.6|5.7|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use involvement of \>= 3% BSA with psoriasis at baseline.|Adjusted difference is the weighted average of the treatment differences across 4 strata of baseline DMARD use by ≥ 3% BSA psoriasis involvement at baseline with the CMH weights. The 95% CI is based on a normal approximation to the weighted average.|||5.7|-16.6|0.3547
72418060|NCT01212770|144346355|SUPERIORITY||Adjusted Difference|6.6||||0.4175|TWO_SIDED|95.0|-8.6|21.8|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use involvement of \>= 3% BSA with psoriasis at baseline.|Adjusted difference is the weighted average of the treatment differences across 4 strata of baseline DMARD use by ≥ 3% BSA psoriasis involvement at baseline with the CMH weights. The 95% CI is based on a normal approximation to the weighted average.|||21.8|-8.6|0.4175
72418061|NCT01212770|144346355|SUPERIORITY||Adjusted Difference|6.4||||0.437|TWO_SIDED|95.0|-9.1|21.8|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use involvement of \>= 3% BSA with psoriasis at baseline.|Adjusted difference is the weighted average of the treatment differences across 4 strata of baseline DMARD use by ≥ 3% BSA psoriasis involvement at baseline with the CMH weights. The 95% CI is based on a normal approximation to the weighted average.|||21.8|-9.1|0.4370
72418062|NCT01212770|144346356|SUPERIORITY||Adjusted Difference|-0.4||||0.9463|TWO_SIDED|195.0|-12.1|11.3|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use involvement of \>= 3% BSA with psoriasis at baseline.|Adjusted difference is the weighted average of the treatment differences across 4 strata of baseline DMARD use by ≥ 3% BSA psoriasis involvement at baseline with the CMH weights. The 95% CI is based on a normal approximation to the weighted average.|||11.3|-12.1|0.9463
72418063|NCT01212770|144346356|SUPERIORITY||Adjusted Difference|-7.7||||0.2032|TWO_SIDED|95.0|-19.3|3.8|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use involvement of \>= 3% BSA with psoriasis at baseline.|Adjusted difference is the weighted average of the treatment differences across 4 strata of baseline DMARD use by ≥ 3% BSA psoriasis involvement at baseline with the CMH weights. The 95% CI is based on a normal approximation to the weighted average.|||3.8|-19.3|0.2032
72418064|NCT01212770|144346357|SUPERIORITY||Adjusted Difference|9.8||||0.2321|TWO_SIDED|95.0|-5.8|25.4|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use involvement of \>= 3% BSA with psoriasis at baseline.|Adjusted difference is the weighted average of the treatment differences across 4 strata of baseline DMARD use by ≥ 3% BSA psoriasis involvement at baseline with the CMH weights. The 95% CI is based on a normal approximation to the weighted average.|||25.4|-5.8|0.2321
72418065|NCT01212770|144346357|SUPERIORITY||Adjusted Difference|9.6||||0.252|TWO_SIDED|95.0|-6.2|25.3|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use involvement of \>= 3% BSA with psoriasis at baseline.|Adjusted difference is the weighted average of the treatment differences across 4 strata of baseline DMARD use by ≥ 3% BSA psoriasis involvement at baseline with the CMH weights. The 95% CI is based on a normal approximation to the weighted average.|||25.3|-6.2|0.2520
72418066|NCT00182754|144346414|SUPERIORITY|||||||0.17|||||||Log Rank|||||||0.17
72418067|NCT02085252|144346425|SUPERIORITY_OR_OTHER|||||||0.0318||||||A 2-sided significance level of 5% was used. There was no adjustment for multiple comparisons.|Chi-squared|||The null hypothesis was that there was no difference between the two treatment strategies.||||0.0318
72418068|NCT01420848|144346463|SUPERIORITY_OR_OTHER|||||||0.006||95.0||||It was used the Post Hoc and the statistical significance was p\<0.05.|ANOVA|||It was carried out the analysis of variance (ANOVA) among the groups at the 3rd (12 sessions) Hypothesis: there is at least one difference among the groups.||||0.006
72418069|NCT01420848|144346463|SUPERIORITY_OR_OTHER|||||||0.023||95.0||||The statistical significance was p\<0.05.|ANOVA|||"It was verified the normality of data distribution and the homogeneity of variance.~It was carried out the analysis of variance (ANOVA) among the groups at the follow-up (after 15 days)."||||0.023
72418070|NCT01420848|144346464|SUPERIORITY_OR_OTHER|||||||0.012||95.0||||After ANOVA it was performed Post Hoc Test and the statistical significance was p\<0.05.|ANOVA|||It was carried out the analysis of variance (ANOVA)of the medium difference among the groups in the 3rd (12 sessions) Hypothesis: there is at least one difference among the groups (State Anxiety)||||0.012
72418071|NCT01420848|144346464|SUPERIORITY_OR_OTHER|||||||0.005||95.0||||After ANOVA, the Post Hoc Test was done and the statistical significance was p\<0.05.|ANOVA|||"It was carried out the analysis of variance (ANOVA) of the medium difference among the groups at the follow-up (after 15 days).~Hypothesis: there is at least one difference among the groups (State Anxiety)."||||0.005
72418072|NCT03053050|144346465|SUPERIORITY||Percentage Difference|-2.1||||0.4941|TWO_SIDED|95.0|-8.3|4.0||Difference between SEL 18 mg and Placebo, 95% confidence interval (CI) and p-value were obtained by stratum-adjusted Mantel-Haenszel method with baseline diabetes mellitus status and Enhanced Liver Fibrosis (ELF) test score as stratification factors.|Mantel Haenszel|||||4.0|-8.3|0.4941
72609755|NCT01004614|144748167|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the two formulations was concluded if the 90% confidence intervals for the ratio of adjusted geometric means for both AUCt and Cmax fell wholly within (80%, 125%).|ratios of adjusted geometric mean|99.3|||||TWO_SIDED|90.0|92.28|106.28||||Parameter estimate = ratio (%) (test/reference) of adjusted geometric means.||Natural log transformed Cmax was analyzed using a mixed effects model with sequence, period and formulation as fixed effects and subject within sequence as a random effect. Adjusted mean difference (test - reference) and 90% CI was obtained from the model and exponentiated to provide estimates of the ratio of adjusted geometric mean and 90% CI for the ratio. Alternative hypothesis of bioequivalence: (H1: θL \<=µT - µR \<=θU); null hypothesis of inequivalence: (Ho: µT - µR \<θL or µT - µR \>θU).||106.28|92.28|
72609756|NCT01004614|144748167|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the two formulations was concluded if the 90% confidence intervals for the ratio of adjusted geometric means for both AUCt and Cmax fell wholly within (80%, 125%).|ratios of adjusted geometric mean|100.84|||||TWO_SIDED|90.0|95.93|106.0||||Parameter estimate = ratio (%) (test/reference) of adjusted geometric means.||Natural log transformed Cmax was analyzed using a mixed effects model with sequence, period and formulation as fixed effects and subject within sequence as a random effect. Adjusted mean difference (test - reference) and 90% CI was obtained from the model and exponentiated to provide estimates of the ratio of adjusted geometric mean and 90% CI for the ratio. Alternative hypothesis of bioequivalence: (H1: θL \<=µT - µR \<=θU); null hypothesis of inequivalence: (Ho: µT - µR \<θL or µT - µR \>θU).||106.00|95.93|
72609757|NCT00486044|144748176|SUPERIORITY_OR_OTHER|||||||0.966||95.0|||||Kruskal-Wallis|||||||0.966
72609758|NCT00486044|144748177|SUPERIORITY_OR_OTHER|||||||0.015||95.0|||||ANCOVA|||||||0.015
72609759|NCT00486044|144748178|SUPERIORITY_OR_OTHER|||||||0.113||95.0|||||Kruskal-Wallis|||||||0.113
72609760|NCT00486044|144748179|SUPERIORITY_OR_OTHER|||||||0.21||95.0|||||Kruskal-Wallis|||||||0.210
72609761|NCT02449434|144748181|OTHER|Using the presence or absence of severe erosive wear as the dependent variable, the unadjusted, sex-and-age- adjusted and fully adjusted associations of the included variables with erosive tooth wear were estimated using unconditional binary logistic regression and reported using odds ratios (OR).|Odds Ratio (OR)|2.25|||<|0.05|TWO_SIDED|95.0||||Only results from fully adjusted regression models will be deemed as significant|Regression, Logistic|Unconditional binary logistic regression and reported using odds ratios and 95% confidence intervals||A minimum sample size of 490 participants (245 in each group) was needed. This calculation assumed the proportion of adults with high dietary acid intake (3+ times/day) was 55% among cases and 40% among controls (expected odds ratio of 2.25), case- control ratio of 1-to-1, 90% statistical power and 95% significance level.||||<0.05
72609762|NCT00966433|144748208|OTHER||Mean Difference (Final Values)|-8.2||||0.0051|TWO_SIDED|95.0|-13.61|-2.79|||t-test, 2 sided|||||-2.79|-13.61|.0051
72609763|NCT00966433|144748209|OTHER||Mean Difference (Final Values)|3.6||||0.0001|TWO_SIDED|95.0|2.97|4.23|||t-test, 2 sided|||||4.23|2.97|.0001
72609764|NCT00966433|144748214|OTHER||Mean Difference (Final Values)|-13.9||||0.0001|TWO_SIDED|95.0|-18.88|-8.92|||t-test, 2 sided|||||-8.92|-18.88|.0001
72609765|NCT00111761|144748240|SUPERIORITY_OR_OTHER||Percentage of participants|25.0||||||95.0|9.8|46.7||||||||46.7|9.8|
72609766|NCT00111761|144748241|SUPERIORITY_OR_OTHER||Percentage of participants|58.0||||||95.0|34.0|80.0||||||||80|34|
72609767|NCT00111761|144748242|SUPERIORITY_OR_OTHER||Percentage|33.3||||||95.0|15.6|55.3||||||||55.3|15.6|
72609768|NCT00111761|144748247|SUPERIORITY_OR_OTHER||Percentage of participants|47.4||||||95.0|24.4|71.1||||||||71.1|24.4|
72609769|NCT00461734|144748260|SUPERIORITY_OR_OTHER|||||||0.4347|||||||two-sided z-test|||||||0.4347
72609770|NCT00461734|144748261|SUPERIORITY_OR_OTHER|||||||0.338|||||||two-sided z-test|||||||0.338
72609771|NCT00461734|144748262|SUPERIORITY_OR_OTHER|||||||0.2257|||||||Wilcoxon (Mann-Whitney)|||||||0.2257
72609772|NCT00461734|144748263|SUPERIORITY_OR_OTHER|||||||0.548|||||||Wilcoxon (Mann-Whitney)|||||||0.5480
72609773|NCT00461734|144748264|SUPERIORITY_OR_OTHER|||||||0.8868|||||||Wilcoxon (Mann-Whitney)|||||||0.8868
72609774|NCT00461734|144748265|SUPERIORITY_OR_OTHER|||||||0.6151|||||||Wilcoxon (Mann-Whitney)|||||||0.6151
72609775|NCT00461734|144748269|SUPERIORITY_OR_OTHER|||||||0.0525|||||||t-test, 2 sided|||||||0.0525
72609776|NCT00461734|144748270|SUPERIORITY_OR_OTHER|||||||0.1852|||||||t-test, 2 sided|||||||0.1852
72609777|NCT00461734|144748272|SUPERIORITY_OR_OTHER|||||||0.9719|||||||Wilcoxon (Mann-Whitney)|||||||0.9719
72609778|NCT00461734|144748273|SUPERIORITY_OR_OTHER|||||||0.8779|||||||Wilcoxon (Mann-Whitney)|||||||0.8779
72609779|NCT00843492|144748288|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.3|||<|0.001|TWO_SIDED|95.0|0.15|0.54|||Fisher Exact|||||0.54|0.15|<0.001
72609780|NCT00720499|144748320|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.002|STANDARD_ERROR_OF_MEAN|0.017||0.8937|TWO_SIDED|95.0|-0.035|0.031|||ANCOVA||Difference calculated as Olo 5 µg + Tio 5 µg minus Olo 2 µg + Tio 5 µg|Based on a ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed).||0.031|-0.035|0.8937
72609781|NCT00720499|144748321|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.023|STANDARD_ERROR_OF_MEAN|0.019||0.2425|TWO_SIDED|95.0|-0.015|0.061|||ANCOVA||Difference calculated as Olo 5 µg + Tio 5 µg minus Olo 2 µg + Tio 5 µg|Based on a ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed).||0.061|-0.015|0.2425
72609782|NCT00720499|144748323|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.005|STANDARD_ERROR_OF_MEAN|0.008||0.5198|TWO_SIDED|95.0|-0.01|0.021|||ANCOVA||Difference calculated as Olo 5 µg + Tio 5 µg minus Olo 2 µg + Tio 5 µg|Test Day 1. Based on a ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed).||0.021|-0.010|0.5198
72609783|NCT00720499|144748323|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.016||0.211|TWO_SIDED|95.0|-0.011|0.051|||ANCOVA||Difference calculated as Olo 5 µg + Tio 5 µg minus Olo 2 µg + Tio 5 µg|Test Day 15. Based on a ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed)||0.051|-0.011|0.2110
72609784|NCT00720499|144748323|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.001|STANDARD_ERROR_OF_MEAN|0.014||0.9368|TWO_SIDED|95.0|-0.029|0.027|||ANCOVA||Difference calculated as Olo 5 µg + Tio 5 µg minus Olo 2 µg + Tio 5 µg|Test day 29. Based on a ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed)||0.027|-0.029|0.9368
72609785|NCT00720499|144748324|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.007|STANDARD_ERROR_OF_MEAN|0.01||0.5339|TWO_SIDED|95.0|-0.027|0.014|||ANCOVA||Difference calculated as Olo 5 µg + Tio 5 µg minus Olo 2 µg + Tio 5 µg|Test Day 1. Based on a ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed)||0.014|-0.027|0.5339
72609786|NCT00720499|144748324|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.022|STANDARD_ERROR_OF_MEAN|0.019||0.2408|TWO_SIDED|95.0|-0.015|0.058|||ANCOVA||Difference calculated as Olo 5 µg + Tio 5 µg minus Olo 2 µg + Tio 5 µg|Test day 15. Based on a ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed)||0.058|-0.015|0.2408
72609787|NCT00720499|144748324|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.007|STANDARD_ERROR_OF_MEAN|0.018||0.7139|TWO_SIDED|95.0|-0.029|0.042|||ANCOVA||Difference calculated as Olo 5 µg + Tio 5 µg minus Olo 2 µg + Tio 5 µg|Test day 29. Based on a ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed)||0.042|-0.029|0.7139
72609788|NCT00720499|144748325|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.004|STANDARD_ERROR_OF_MEAN|0.015||0.7906|TWO_SIDED|95.0|-0.026|0.034|||ANCOVA||Difference calculated as Olo 5 µg + Tio 5 µg minus Olo 2 µg + Tio 5 µg|Based on a ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed).||0.034|-0.026|0.7906
72418073|NCT03053050|144346465|SUPERIORITY||Percentage Difference|-0.3||||0.9321|TWO_SIDED|95.0|-6.6|6.0||Difference between SEL 6 mg and Placebo, 95% CI and p-value were obtained by stratum-adjusted Mantel-Haenszel method with baseline diabetes mellitus status and ELF test score as stratification factors.|Mantel Haenszel|||||6.0|-6.6|0.9321
72609789|NCT00720499|144748326|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.007|STANDARD_ERROR_OF_MEAN|0.038||0.8473|TWO_SIDED|95.0|-0.067|0.082|||ANCOVA||Difference calculated as Olo 5 µg + Tio 5 µg minus Olo 2 µg + Tio 5 µg|Based on a ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed).||0.082|-0.067|0.8473
72609790|NCT00720499|144748327|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.032|STANDARD_ERROR_OF_MEAN|0.031||0.2944|TWO_SIDED|95.0|-0.029|0.094|||ANCOVA||Difference calculated as Olo 5 µg + Tio 5 µg minus Olo 2 µg + Tio 5 µg|Test Day 15. Based on a ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed).||0.094|-0.029|0.2944
72609791|NCT00720499|144748327|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.028||0.718|TWO_SIDED|95.0|-0.046|0.066|||ANCOVA||Difference calculated as Olo 5 µg + Tio 5 µg minus Olo 2 µg + Tio 5 µg|Test day 29. Based on a ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed).||0.066|-0.046|0.7180
72609792|NCT00720499|144748329|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.001|STANDARD_ERROR_OF_MEAN|0.015||0.9384|TWO_SIDED|95.0|-0.029|0.032|||ANCOVA||Difference calculated as Olo 5 µg + Tio 5 µg minus Olo 2 µg + Tio 5 µg|Test day 1. Based on a ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed)||0.032|-0.029|0.9384
72609793|NCT00720499|144748329|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.037|STANDARD_ERROR_OF_MEAN|0.026||0.1583|TWO_SIDED|95.0|-0.014|0.088|||ANCOVA||Difference calculated as Olo 5 µg + Tio 5 µg minus Olo 2 µg + Tio 5 µg|Test day 15. Based on a ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed).||0.088|-0.014|0.1583
72609794|NCT00720499|144748329|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.029|STANDARD_ERROR_OF_MEAN|0.027||0.2914|TWO_SIDED|95.0|-0.025|0.082|||ANCOVA||Difference calculated as Olo 5 µg + Tio 5 µg minus Olo 2 µg + Tio 5 µg|Test day 29. Based on a ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed).||0.082|-0.025|0.2914
72609795|NCT00720499|144748330|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.035|STANDARD_ERROR_OF_MEAN|0.03||0.2485|TWO_SIDED|95.0|-0.024|0.094|||ANCOVA||Difference calculated as Olo 5 µg + Tio 5 µg minus Olo 2 µg + Tio 5 µg|Based on a ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed).||0.094|-0.024|0.2485
72325928|NCT00980148|144175321|NON_INFERIORITY_OR_EQUIVALENCE|This noninferiority study tested the null hypothesis that the failure rate of azithromycin is 5% higher than that of doxycycline against the alternative hypothesis that there is no difference between the two treatments. The treatment failure rate was assumed to be 3% for both treatments. To test this hypothesis at the one-sided 0.10 significance level with power of 0.90 required 153 study subjects per arm in the per-protocol population.|Risk Difference (RD)|3.2|||||ONE_SIDED|90.0||5.9|||||The risk difference is the percentage in the azithromycin arm with treatment failure minus the percentage in the doxycycline arm with treatment failure. Noninferiority of azithromycin would be supported if the upper 90% confidence limit is below 5%.|This noninferiority study tested the null hypothesis that the failure rate of azithromycin is 5% higher than that of doxycycline against the alternative hypothesis that there is no difference between the two treatments. The one-sided 90% exact confidence interval was used to estimate the difference between the two failures rates.||5.9||
72325929|NCT03420742|144175336|OTHER||Geometric least squares mean ratio|0.741|||||TWO_SIDED|90.0|0.6|0.915|||||The ratios of geometric mean were calculated on the basis of the within-participant variance. Participant was treated as a random effect in the model.|||0.915|0.600|
72325930|NCT03420742|144175337|OTHER||Geometric least squares mean ratio|0.836|||||TWO_SIDED|90.0|0.662|1.06|||||The ratios of geometric mean were calculated on the basis of the within-participant variance. Participant was treated as a random effect in the model.|||1.06|0.662|
72325931|NCT01119443|144175360|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence between pramipexole ER 1.5 mg x 1 tablet q.d. and pramipexole ER 0.375 mg x 4 tablets q.d. in fed condition|Test/Reference Ratio of the mean x 100|104.2|||||TWO_SIDED|90.0|98.3|110.3|||ANOVA||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||110.3|98.3|
72325932|NCT01119443|144175361|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence between pramipexole ER 1.5 mg x 1 tablet q.d. and pramipexole ER 0.375 mg x 4 tablets q.d. in fed condition|Test/Reference Ratio of the mean x 100|104.8||||||90.0|100.1|109.8|||ANOVA||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||109.8|100.1|
72325933|NCT01119443|144175362|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence between pramipexole ER 1.5 mg x 1 tablet q.d. and pramipexole ER 0.375 mg x 4 tablets q.d. in fed condition|Test/Reference Ratio of the mean x 100|108.31|||||TWO_SIDED|90.0|95.634|122.676|||ANOVA||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||122.676|95.634|
72325934|NCT01119443|144175363|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence between pramipexole ER 1.5 mg x 1 tablet q.d. and pramipexole ER 0.375 mg x 4 tablets q.d. in fed condition|Test/Reference Ratio of the mean x 100|106.85|||||TWO_SIDED|90.0|93.189|122.251|||ANOVA||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||122.251|93.189|
72325935|NCT01119443|144175364|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence between pramipexole ER 1.5 mg x 1 tablet q.d. and pramipexole ER 0.375 mg x 4 tablets q.d. in fed condition|Test/Reference Ratio of the mean x 100|98.426|||||TWO_SIDED|90.0|84.276|112.58|||ANOVA||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||112.58|84.276|
72418074|NCT03053050|144346467|SUPERIORITY||Percentage Difference|-4.0||||0.2593|TWO_SIDED|95.0|-10.8|2.9||Difference between SEL 18 mg and Placebo, 95% CI and p-value were obtained by stratum-adjusted Mantel-Haenszel method with baseline diabetes mellitus status and ELF test score as stratification factors.|Mantel Haenszel|||||2.9|-10.8|0.2593
72418075|NCT03053050|144346467|SUPERIORITY||Percentage Difference|-0.9||||0.808|TWO_SIDED|95.0|-7.9|6.1||Difference between SEL 6 mg vs Placebo, 95% CI and p-value were obtained by stratum-adjusted Mantel-Haenszel method with baseline diabetes mellitus status and ELF test score as stratification factors.|Mantel Haenszel|||||6.1|-7.9|0.8080
72418076|NCT03053050|144346469|SUPERIORITY||Percentage Difference|-2.0||||0.5636|TWO_SIDED|95.0|-8.7|4.8||Difference between SEL 18 mg and Placebo, 95% CI and p-value were obtained by stratum-adjusted Mantel-Haenszel method with baseline diabetes mellitus status and ELF test score as stratification factors.|Mantel Haenszel|||||4.8|-8.7|0.5636
72418077|NCT03053050|144346469|SUPERIORITY||Percentage Difference|-1.9||||0.5915|TWO_SIDED|95.0|-8.6|4.9||Difference between SEL 6 mg and Placebo, 95% CI and p-value were obtained by stratum-adjusted Mantel-Haenszel method with baseline diabetes mellitus status and ELF test score as stratification factors.|Mantel Haenszel|||||4.9|-8.6|0.5915
72418078|NCT03053050|144346471|SUPERIORITY||Percentage Difference|-3.2||||0.2455|TWO_SIDED|95.0|-8.5|2.2||Difference between SEL 18 mg and Placebo, 95% CI and p-value were obtained by stratum-adjusted Mantel-Haenszel method with baseline diabetes mellitus status and ELF test score as stratification factors.|Mantel Haenszel|||||2.2|-8.5|0.2455
72418079|NCT03053050|144346471|SUPERIORITY||Percentage Difference|-4.0||||0.1371|TWO_SIDED|95.0|-9.3|1.3||Difference between SEL 6 mg and Placebo, 95% CI and p-value were obtained by stratum-adjusted Mantel-Haenszel method with baseline diabetes mellitus status and ELF test score as stratification factors.|Mantel Haenszel|||||1.3|-9.3|0.1371
72325936|NCT01119443|144175365|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence between pramipexole ER 1.5 mg x 1 tablet q.d. and pramipexole ER 0.375 mg x 4 tablets q.d. in fed condition|Test/Reference Ratio of the mean x 100|95.11|||||TWO_SIDED|90.0|82.461|109.698|||ANOVA||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||109.698|82.461|
72325937|NCT01119443|144175367|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence between pramipexole ER 1.5 mg x 1 tablet q.d. and pramipexole ER 0.375 mg x 4 tablets q.d. in fed condition|Test/Reference Ratio of the mean x 100|104.07|||||TWO_SIDED|90.0|91.585|118.263|||ANOVA||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||118.263|91.585|
72325938|NCT01119443|144175368|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence between pramipexole ER 1.5 mg x 1 tablet q.d. and pramipexole ER 0.375 mg x 4 tablets q.d. in fasted condition|Test/Reference Ratio of the mean x 100|93.6||||||90.0|86.9|100.8|||ANOVA||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||100.8|86.9|
72325939|NCT01119443|144175369|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence between pramipexole ER 1.5 mg x 1 tablet q.d. and pramipexole ER 0.375 mg x 4 tablets q.d. in fasted condition|Test/Reference Ratio of the mean x 100|100.2|||||TWO_SIDED|90.0|94.0|106.7|||ANOVA||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||106.7|94.0|
72609796|NCT00720499|144748331|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.046|STANDARD_ERROR_OF_MEAN|0.043||0.2875|TWO_SIDED|95.0|-0.039|0.13|||ANCOVA||Difference calculated as Olo 5 µg + Tio 5 µg minus Olo 2 µg + Tio 5 µg|Based on a ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed).||0.130|-0.039|0.2875
72609797|NCT00720499|144748332|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.984|STANDARD_ERROR_OF_MEAN|2.038||0.6299|TWO_SIDED|95.0|-3.046|5.015|||ANCOVA||Difference calculated as Olo 5 µg + Tio 5 µg minus Olo 2 µg + Tio 5 µg|Test day 1. Based on a ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed).||5.015|-3.046|0.6299
72325940|NCT01119443|144175370|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence between pramipexole ER 1.5 mg x 1 tablet q.d. and pramipexole ER 0.375 mg x 4 tablets q.d. in fasted condition|Test/Reference Ratio of the mean x 100|86.57|||||TWO_SIDED|90.0|73.583|101.854|||ANOVA||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||101.854|73.583|
72325941|NCT01119443|144175371|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence between pramipexole ER 1.5 mg x 1 tablet q.d. and pramipexole ER 0.375 mg x 4 tablets q.d. in fasted condition|Test/Reference Ratio of the mean x 100|86.57|||||TWO_SIDED|90.0|73.583|101.854|||ANOVA||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||101.854|73.583|
72325942|NCT01119443|144175372|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence between pramipexole ER 1.5 mg x 1 tablet q.d. and pramipexole ER 0.375 mg x 4 tablets q.d. in fasted condition|Test/Reference Ratio of the mean x 100|99.069|||||TWO_SIDED|90.0|80.688|117.45|||ANOVA||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||117.45|80.688|
72325943|NCT01119443|144175373|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence between pramipexole ER 1.5 mg x 1 tablet q.d. and pramipexole ER 0.375 mg x 4 tablets q.d. in fasted condition|Test/Reference Ratio of the mean x 100|109.48|||||TWO_SIDED|90.0|89.571|133.811|||ANOVA||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||133.811|89.571|
72325944|NCT01119443|144175375|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence between pramipexole ER 1.5 mg x 1 tablet q.d. and pramipexole ER 0.375 mg x 4 tablets q.d. in fasted condition|Test/Reference Ratio of the mean x 100|92.63|||||TWO_SIDED|90.0|77.871|110.185|||ANOVA||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||110.185|77.871|
72325945|NCT00775268|144175412|SUPERIORITY||||||<|0.001|||||||Wilcoxon signed-rank test|||||||<0.001
72325946|NCT00775268|144175413|SUPERIORITY|||||||0.0313|||||||Wilcoxon matched-pairs signed rank test|||||||0.0313
72325947|NCT01194245|144175429|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority would be supported if the upper limit of the two-sided 95% confidence interval for the difference between Analog-PH20 and the comparator (insulin lispro) did not exceed 0.40.|LS Means Difference|0.05||||0.2878|TWO_SIDED|95.0|-0.05|0.15|||Mixed Models Analysis|||Approximately 110 participants were to be enrolled, allowing approximately 88 participants to complete both treatment periods (44 for each investigational drug). Assuming a dropout rate of no more than 20%, intra-participant correlation of 0.80, standard deviation of 1.2, and a true difference of 0, the study would have a greater than 90% power to show that Analog-PH20 was non-inferior to insulin lispro alone with respect to the change from baseline in A1C at the end of each treatment period.||0.15|-0.05|0.2878
72325948|NCT05069649|144175457|SUPERIORITY|||||||0.0046|||||||Chi-squared|||||||0.0046
72325949|NCT05069649|144175458|SUPERIORITY|||||||0.2488|||||||Fisher Exact|||||||0.2488
72325950|NCT05069649|144175459|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.0
72325951|NCT05069649|144175460|SUPERIORITY|||||||0.32|||||||Fisher Exact|||||||0.32
72325952|NCT05069649|144175461|SUPERIORITY|||||||0.02|||||||Fisher Exact|||||||0.02
72325953|NCT05069649|144175462|SUPERIORITY|||||||0.49|||||||Fisher Exact|||||||0.49
72325954|NCT01074125|144175488|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3376|||<|0.0001|TWO_SIDED||||||Regression, Linear|||To assess dose ranging, the primary efficacy variable will be analyzed via a model with dose effect. Positive dose ranging confirmed if the null hypothesis of slope =0 was rejected at a significance level of 0.05||||<0.0001
72325955|NCT01824290|144175517|SUPERIORITY||Mean Difference (Final Values)|23.88|STANDARD_ERROR_OF_MEAN|29.114|||TWO_SIDED|80.0|-14.25|62.0||||||||62.00|-14.25|
72325956|NCT00527618|144175524|SUPERIORITY_OR_OTHER||Slope|-0.27|||<|0.001|TWO_SIDED|95.0|-0.41|-0.14|||Mixed Models Analysis|Adjusted for baseline plasma HIV-1 RNA.|Acyclovir was coded as 0 and valacyclovir as 1. The beta-coefficient (slope) indicates the average difference in HIV-1 RNA on valacyclovir and acyclovir; a negative number indicates that plasma HIV-1 RNA was lower on valacyclovir than acyclovir.|We estimated that a sample size of 29 participants, with 4 weeks of weekly plasma HIV-1 RNA levels per treatment arm, would be required to detect a 0.25 log10 copies/ml difference in plasma HIV-1 RNA between the study arms with 80% power, at a two-sided type I error rate of 5%.||-0.14|-0.41|<0.001
72325957|NCT00527618|144175525|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.95||||0.78|TWO_SIDED|95.0|0.66|1.37|||Random effects poission regression|Adjusted for age.||We estimated that 26 participants would be required to detect a 50% reduction in genital HSV shedding with 80% power, at a two-sided type I error rate of 5%.||1.37|0.66|0.78
72325958|NCT00527618|144175526|SUPERIORITY_OR_OTHER|||||||0.16|||||||Wilcoxon (Mann-Whitney)|||||||0.16
72325959|NCT00527618|144175527|SUPERIORITY_OR_OTHER|||||||0.67|||||||Mixed Models Analysis|||||||0.67
72325960|NCT02706925|144175536|SUPERIORITY_OR_OTHER_LEGACY||Slope|1.2951|STANDARD_DEVIATION|0.0352|||TWO_SIDED|95.0|1.2242|1.366|||||The model of dose proportionality was power model that describes the functional relationship between the dose and PK endpoints. Perfect dose proportionality would correspond to a slope of 1. Standard deviation is actually the standard error of slope.|||1.3660|1.2242|
72325961|NCT02706925|144175536|SUPERIORITY_OR_OTHER_LEGACY||Slope|1.088|STANDARD_DEVIATION|0.0843|||TWO_SIDED|95.0|0.9128|1.2633|||||The model of dose proportionality was power model that describes the functional relationship between the dose and PK endpoints. Perfect dose proportionality would correspond to a slope of 1. Standard deviation is actually the standard error of slope.|||1.2633|0.9128|
72325962|NCT02706925|144175536|SUPERIORITY_OR_OTHER_LEGACY||Slope|1.1846|STANDARD_DEVIATION|0.3328|||TWO_SIDED|95.0|0.4791|1.89|||||The model of dose proportionality was power model that describes the functional relationship between the dose and PK endpoints. Perfect dose proportionality would correspond to a slope of 1. Standard deviation is actually the standard error of slope.|||1.8900|0.4791|
72325963|NCT02706925|144175537|SUPERIORITY_OR_OTHER_LEGACY||Slope|1.2114|STANDARD_DEVIATION|0.035|||TWO_SIDED|95.0|1.1409|1.2818|||||The model of dose proportionality was power model that describes the functional relationship between the dose and PK endpoints. Perfect dose proportionality would correspond to a slope of 1. Standard deviation is actually the standard error of slope.|||1.2818|1.1409|
72609798|NCT00720499|144748332|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.311|STANDARD_ERROR_OF_MEAN|3.156||0.0475|TWO_SIDED|95.0|0.07|12.553|||ANCOVA||Difference calculated as Olo 5 µg + Tio 5 µg minus Olo 2 µg + Tio 5 µg|Test day 15. Based on a ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed).||12.553|0.070|0.0475
72325964|NCT02706925|144175537|SUPERIORITY_OR_OTHER_LEGACY||Slope|1.0771|STANDARD_DEVIATION|0.0524|||TWO_SIDED|95.0|0.9696|1.1845|||||The model of dose proportionality was power model that describes the functional relationship between the dose and PK endpoints. Perfect dose proportionality would correspond to a slope of 1. Standard deviation is actually the standard error of slope.|||1.1845|0.9696|
72325965|NCT02706925|144175537|SUPERIORITY_OR_OTHER_LEGACY||Slope|1.3969|STANDARD_DEVIATION|0.3965|||TWO_SIDED|95.0|0.5563|2.2375|||||The model of dose proportionality was power model that describes the functional relationship between the dose and PK endpoints. Perfect dose proportionality would correspond to a slope of 1. Standard deviation is actually the standard error of slope.|||2.2375|0.5563|
72325966|NCT04005586|144175544|OTHER|The comparison was made by descriptive statistics.||||||||||||||||Two different historical controls implanted under NCT01496066 were used.|The LAL treatment group had a mean MRCYL of -0.14 (+/- 0.21D) compared to -0.33 (+/- 0.29D) and -0.40 (+/- 0.36D) for the LAL historical control group and the monofocal IOL historical control group in NCT01496066 respectively.|||
72325967|NCT04005586|144175545|OTHER|The comparison was made by descriptive statistics.||||||||||||||||Two different historical controls implanted under NCT01496066 were used.|The LAL treatment group MRCYL change from baseline was 0.36 (+/- 0.21D) compared to 0.17 (+/- 0.29D) and 0.10 (+/- 0.36D) for the LAL historical control group and the monofocal IOL historical control group in NCT01496066, respectively.|||
72325968|NCT00363311|144175567|SUPERIORITY_OR_OTHER||Relative Risk Estimate|0.56||||0.009||95.0|0.36|0.87||Statistical data are for Year 1.5|Log Rank|||||0.87|0.36|0.009
72325969|NCT00363311|144175567|SUPERIORITY_OR_OTHER||Relative Risk Estimate|0.61||||0.007||95.0|0.43|0.88||Statistical data are for Overall (Years 0-3)|Log Rank|||||0.88|0.43|0.007
72325970|NCT00363311|144175568|SUPERIORITY_OR_OTHER||Relative Risk Estimate|0.46||||0.13||95.0|0.16|1.31||Statistical data are for Year 1.5|Log Rank|||||1.31|0.16|0.13
72325971|NCT00363311|144175568|SUPERIORITY_OR_OTHER||Relative Risk Estimate|0.48||||0.053||95.0|0.22|1.03||Statistical data are for Overall (Years 0-3)|Log Rank|||||1.03|0.22|0.053
72325972|NCT00363311|144175569|SUPERIORITY_OR_OTHER||Relative Risk Estimate|0.59||||0.031||95.0|0.36|0.96||Statistical data are for Year 1.5|Log Rank|||||0.96|0.36|0.031
72325973|NCT00363311|144175569|SUPERIORITY_OR_OTHER||Relative Risk Estimate|0.7||||0.079||95.0|0.46|1.05||Statistical data are for Overall (Years 0-3)|Log Rank|||||1.05|0.46|0.079
72325974|NCT00363311|144175570|SUPERIORITY_OR_OTHER|||||||0.65||95.0|||||Fisher Exact|||||||0.65
72325975|NCT00363311|144175571|SUPERIORITY_OR_OTHER|||||||0.024||95.0|||||Fisher Exact|||||||0.024
72325976|NCT00363311|144175578|SUPERIORITY_OR_OTHER|||||||0.2||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.20
72325977|NCT00363311|144175579|SUPERIORITY_OR_OTHER|||||||0.039||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.039
72325978|NCT00363311|144175581|SUPERIORITY_OR_OTHER|||||||0.8||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.80
72325979|NCT00363311|144175582|SUPERIORITY_OR_OTHER|||||||0.12||95.0|||||Fisher Exact|||||||0.12
72325980|NCT00120627|144175600|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||ANOVA|F (1,144) = 4.12, p \< .05||2 group (treatment vs. control) by 2 time (pre-intervention and post-intervention) one-way ANOVA||||<0.05
72325981|NCT00120627|144175600|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Fisher Exact|||||||<0.05
72325982|NCT00120627|144175601|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||ANOVA|||Intent to treat analysis using Expectation-Maximization (EM) algorithm in SPSS, a maximum-likelihood method based on group assignment, demographic variables and clinical variables.||||<0.05
72325983|NCT00120627|144175602|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANOVA|||2 group (treatment vs control) by 2 time points (pre-intervention and post-intervention)||||<0.0001
72325984|NCT00120627|144175603|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANOVA|||||||<0.001
72325985|NCT00120627|144175603|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Mediation using Sobel Test|||||||<0.001
72325986|NCT00120627|144175604|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||ANOVA|||||||<0.01
72325987|NCT00120627|144175605|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||ANOVA|||2 group (treatment vs control) by 2 time (pre-intervention and post-intervention) ANOVA||||< 0.05
72325988|NCT00120627|144175606|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANOVA|||Depression Subscale||||<0.001
72325989|NCT00120627|144175606|SUPERIORITY_OR_OTHER||||||=|0.31|TWO_SIDED||||||ANOVA|||Anxiety Subscale||||=0.31
72325990|NCT00120627|144175606|SUPERIORITY_OR_OTHER||||||=|0.44|TWO_SIDED||||||ANOVA|||Somatization Subscale||||=0.44
72325991|NCT00120627|144175607|SUPERIORITY_OR_OTHER||||||=|0.66|TWO_SIDED||||||ANOVA|||Post-hoc analysis||||=0.66
72325992|NCT00120627|144175608|SUPERIORITY_OR_OTHER||||||=|0.18|TWO_SIDED||||||ANOVA|||||||= 0.18
72325993|NCT00120627|144175609|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||ANOVA|||||||< 0.01
72325994|NCT01595529|144175610|NON_INFERIORITY|The primary analysis was a non-inferiority test comparing the proportion of subjects with symptomatic UTIs at the TOC visit to evaluate whether the difference was within the 5% equivalence interval. This test was conducted by calculating the one-sided 95% upper confidence limit for the difference in symptomatic UTI (treatment failure) rate. If this limit was less than or equal to the equivalence interval (0.05), then would conclude that short course therapy is not inferior to standard therapy.|Risk Difference (RD)|0.035569|||||ONE_SIDED|95.0||0.054844||||||||0.054844||
72325995|NCT01595529|144175611|NON_INFERIORITY|The primary analysis was a non-inferiority test comparing the proportion of subjects with symptomatic UTIs at the TOC visit to evaluate whether the difference was within the 5% equivalence interval. This test was conducted by calculating the one-sided 95% upper confidence limit for the difference in symptomatic UTI (treatment failure) rate. If this limit was less than or equal to the equivalence interval (0.05), then would conclude that short course therapy is not inferior to standard therapy.|Risk Difference (RD)|0.022169|||||ONE_SIDED|95.0||0.03939||||||||0.03939||
72325996|NCT01595529|144175612|SUPERIORITY||Risk Difference (RD)|-0.00356|||||TWO_SIDED|95.0|-0.03323|0.026102||||||||0.026102|-0.03323|
72325997|NCT01595529|144175613|SUPERIORITY||Risk Difference (RD)|-0.00994|||||TWO_SIDED|95.0|-0.04012|0.020236||||||||0.020236|-0.04012|
72609799|NCT00720499|144748332|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.552|STANDARD_ERROR_OF_MEAN|2.67||0.562|TWO_SIDED|95.0|-3.729|6.833|||ANCOVA||Difference calculated as Olo 5 µg + Tio 5 µg minus Olo 2 µg + Tio 5 µg|Test day 29. Based on a ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed).||6.833|-3.729|0.5620
72609800|NCT00720499|144748333|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.179|STANDARD_ERROR_OF_MEAN|2.342||0.9391|TWO_SIDED|95.0|-4.812|4.454|||ANCOVA||Difference calculated as Olo 5 µg + Tio 5 µg minus Olo 2 µg + Tio 5 µg|Test day 1. Based on a ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed).||4.454|-4.812|0.9391
72609801|NCT00720499|144748333|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.48|STANDARD_ERROR_OF_MEAN|3.559||0.0709|TWO_SIDED|95.0|-0.56|13.52|||ANCOVA||Difference calculated as Olo 5 µg + Tio 5 µg minus Olo 2 µg + Tio 5 µg|Test day 15. Based on a ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed).||13.520|-0.560|0.0709
72609802|NCT00720499|144748333|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.099|STANDARD_ERROR_OF_MEAN|3.134||0.3245|TWO_SIDED|95.0|-3.1|9.298|||ANCOVA||Difference calculated as Olo 5 µg + Tio 5 µg minus Olo 2 µg + Tio 5 µg|Test day 29. Based on a ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed).||9.298|-3.100|0.3245
72609803|NCT00720499|144748334|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|4.655||0.8808|TWO_SIDED|95.0|-9.914|8.514|||ANCOVA||Difference calculated as Olo 5 µg + Tio 5 µg minus Olo 2 µg + Tio 5 µg|Based on a ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed).||8.514|-9.914|0.8808
72609804|NCT00720499|144748335|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.119|STANDARD_ERROR_OF_MEAN|2.177||0.6081|TWO_SIDED|95.0|-3.19|5.429|||ANCOVA||Difference calculated as Olo 5 µg + Tio 5 µg minus Olo 2 µg + Tio 5 µg|Test week 1. Based on a ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed).||5.429|-3.190|0.6081
72609805|NCT00720499|144748335|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.339|STANDARD_ERROR_OF_MEAN|2.342||0.5686|TWO_SIDED|95.0|-3.296|5.973|||ANCOVA||Difference calculated as Olo 5 µg + Tio 5 µg minus Olo 2 µg + Tio 5 µg|Test Week 2. Based on a ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed).||5.973|-3.296|0.5686
72609806|NCT00720499|144748335|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.653|STANDARD_ERROR_OF_MEAN|2.294||0.7765|TWO_SIDED|95.0|-3.888|5.194|||ANCOVA||Difference calculated as Olo 5 µg + Tio 5 µg minus Olo 2 µg + Tio 5 µg|Test Week 3. Based on a ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed).||5.194|-3.888|0.7765
72325998|NCT01595529|144175614|SUPERIORITY|||||||0.2282|||||||Chi-squared|||At Test of Cure Visit||||0.2282
72325999|NCT01595529|144175614|SUPERIORITY|||||||0.4876|||||||Chi-squared|||At Outcome Assessment Visit||||0.4876
72326000|NCT01595529|144175615|SUPERIORITY|||||||0.4184|||||||Chi-squared|||At Test of Cure Visit||||0.4184
72609807|NCT00720499|144748335|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.654|STANDARD_ERROR_OF_MEAN|2.543||0.5166|TWO_SIDED|95.0|-3.379|6.686|||ANCOVA||Difference calculated as Olo 5 µg + Tio 5 µg minus Olo 2 µg + Tio 5 µg|Test Week 4. Based on a ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed).||6.686|-3.379|0.5166
72609808|NCT00720499|144748336|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.303|STANDARD_ERROR_OF_MEAN|2.585||0.2037|TWO_SIDED|95.0|-1.813|8.418|||ANCOVA||Difference calculated as Olo 5 µg + Tio 5 µg minus Olo 2 µg + Tio 5 µg|Test Week 1. Based on a ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed).||8.418|-1.813|0.2037
72609809|NCT00720499|144748336|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.393|STANDARD_ERROR_OF_MEAN|2.738||0.6118|TWO_SIDED|95.0|-4.027|6.813|||ANCOVA||Difference calculated as Olo 5 µg + Tio 5 µg minus Olo 2 µg + Tio 5 µg|Test Week 2. Based on a ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed).||6.813|-4.027|0.6118
72609810|NCT00720499|144748336|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.695|STANDARD_ERROR_OF_MEAN|2.498||0.4988|TWO_SIDED|95.0|-3.251|6.64|||ANCOVA||Difference calculated as Olo 5 µg + Tio 5 µg minus Olo 2 µg + Tio 5 µg|Test Week 3. Based on a ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed).||6.640|-3.251|0.4988
72609811|NCT00720499|144748336|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.039|STANDARD_ERROR_OF_MEAN|2.478||0.6757|TWO_SIDED|95.0|-5.944|3.865|||ANCOVA||Difference calculated as Olo 5 µg + Tio 5 µg minus Olo 2 µg + Tio 5 µg|Test Week 4. Based on a ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed).||3.865|-5.944|0.6757
72609812|NCT00720499|144748337|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.011|STANDARD_ERROR_OF_MEAN|0.08||0.8901|TWO_SIDED|95.0|-0.147|0.169|||ANCOVA||Difference calculated as Olo 5 µg + Tio 5 µg minus Olo 2 µg + Tio 5 µg|Test Week 1. Based on a ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed).||0.169|-0.147|0.8901
72609813|NCT00720499|144748337|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.12|STANDARD_ERROR_OF_MEAN|0.086||0.1647|TWO_SIDED|95.0|-0.29|0.05|||ANCOVA||Difference calculated as Olo 5 µg + Tio 5 µg minus Olo 2 µg + Tio 5 µg|Test Week 2. Based on a ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed).||0.050|-0.290|0.1647
72609814|NCT00720499|144748337|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.002|STANDARD_ERROR_OF_MEAN|0.09||0.9822|TWO_SIDED|95.0|-0.18|0.176|||ANCOVA||Difference calculated as Olo 5 µg + Tio 5 µg minus Olo 2 µg + Tio 5 µg|Test Week 3. Based on a ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed).||0.176|-0.180|0.9822
72609815|NCT00720499|144748337|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.04|STANDARD_ERROR_OF_MEAN|0.09||0.6542|TWO_SIDED|95.0|-0.218|0.137|||ANCOVA||Difference calculated as Olo 5 µg + Tio 5 µg minus Olo 2 µg + Tio 5 µg|Test Week 4. Based on a ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed).||0.137|-0.218|0.6542
72326001|NCT01595529|144175615|SUPERIORITY|||||||0.9782|||||||Chi-squared|||At Outcome Assessment Visit||||0.9782
72326002|NCT01595529|144175616|SUPERIORITY||Risk Difference (RD)|-0.05277|||||TWO_SIDED|95.0|-0.08857|-0.01698||||||||-0.01698|-0.08857|
72326003|NCT01595529|144175617|SUPERIORITY||Risk Difference (RD)|-0.05664|||||TWO_SIDED|95.0|-0.09479|-0.0185||||||||-0.01850|-0.09479|
72609816|NCT00720499|144748338|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.114|STANDARD_ERROR_OF_MEAN|0.116||0.3269|TWO_SIDED|95.0|-0.342|0.115|||ANCOVA||Difference calculated as Olo 5 µg + Tio 5 µg minus Olo 2 µg + Tio 5 µg|Based on a ANCOVA with terms for treatment, centre, patient within centre and period (all effects fixed).||0.115|-0.342|0.3269
72609817|NCT00720499|144748339|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.005|STANDARD_ERROR_OF_MEAN|0.089||0.9557|TWO_SIDED|95.0|-0.181|0.171|||ANCOVA||Difference calculated as Olo 5 µg + Tio 5 µg minus Olo 2 µg + Tio 5 µg|Test day 15. Based on a ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed).||0.171|-0.181|0.9557
72609818|NCT00720499|144748339|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.019|STANDARD_ERROR_OF_MEAN|0.08||0.8096|TWO_SIDED|95.0|-0.178|0.14|||ANCOVA||Difference calculated as Olo 5 µg + Tio 5 µg minus Olo 2 µg + Tio 5 µg|Test day 29. Based on a ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed).||0.140|-0.178|0.8096
72609819|NCT01621009|144748395|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.61|||>|0.05|TWO_SIDED|95.0|0.78|3.36|||Regression, Logistic|||||3.36|.78|>0.05
72609820|NCT01621009|144748395|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.13|||>|0.05|TWO_SIDED|95.0|0.52|2.44|||Regression, Logistic|||||2.44|.52|>0.05
72609821|NCT00855218|144748420|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.797||||0.072||95.0|0.588|1.08||stratified one-sided (alpha=0.15). adjusted for region and Alfa-fetoprotein (AFP) level at baseline.|Log Rank|||||1.080|0.588|0.072
72609822|NCT00855218|144748421|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.898||||0.295||95.0|0.606|1.33|||Log Rank|stratified one-sided (alpha=0.15). adjusted for region and AFP level at baseline.||||1.330|0.606|0.295
72609823|NCT00855218|144748422|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.586||||0.999||95.0|1.2|2.096|||Log Rank|startified one-sided (alpha=0.15), adjusted for region and AFP level at baseline||||2.096|1.200|0.999
72609824|NCT00855218|144748423|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.621||||0.076||95.0|0.321|1.2|||Log Rank|stratified one sided (alpha=0.15), adjusted on region and AFP level at baseline||||1.200|0.321|0.076
72609825|NCT03191552|144748435|SUPERIORITY|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||||||0.001
72609826|NCT03191552|144748436|SUPERIORITY|||||||0.027||||||Mann-Whitney U test was used to test the significance of pairwise differences using Bonferroni correction to adjust for multiple comparisons.p value of less than 0.05/3 was determined as the level of statistical significance.|Kruskal-Wallis|||||||0.027
72609827|NCT03191552|144748437|SUPERIORITY|||||||0.008||||||Mann-WhitneyU test was used to test the significance of pairwise differences using Bonferroni correction to adjust for multiple comparisons.p value of less than 0.05/3 was determined as the level of statistical significance.|Kruskal-Wallis|||||||0.008
72609828|NCT03191552|144748438|SUPERIORITY|Mann-WhitneyU test was used to test the significance of pairwise differences using Bonferroni correction to adjust for multiple comparisons.p value of less than 0.05/3 was determined as the level of statistical significance.||||||0.004||||||Mann-WhitneyU test was performed to test the significance of pairwise differences using Bonferroni correction to adjust for multiple comparisons.p value of less than 0.05/3 was determined as the level of statistical significance.|Kruskal-Wallis|||||||0.004
72609829|NCT03191552|144748439|SUPERIORITY|||||||0.837|||||||Kruskal-Wallis|||||||0.837
72609830|NCT03191552|144748440|SUPERIORITY|||||||0.57|||||||Kruskal-Wallis|||||||0.570
72609831|NCT03191552|144748441|SUPERIORITY|||||||0.334|||||||Kruskal-Wallis|||||||0.334
72609832|NCT03191552|144748442|SUPERIORITY|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||||||0.001
72609833|NCT03191552|144748443|SUPERIORITY|||||||0.77|||||||Kruskal-Wallis|||||||0.77
72609834|NCT03191552|144748444|SUPERIORITY|||||||0.889|||||||Kruskal-Wallis|||||||0.889
72609835|NCT03191552|144748445|SUPERIORITY|||||||0.956|||||||Kruskal-Wallis|||||||0.956
72609836|NCT03191552|144748446|SUPERIORITY||||||,|0||||||Mann-WhitneyU test was used to test the significance of pairwise differences using Bonferroni correction to adjust for multiple comparisons.p value of less than 0.05/3 was determined as the level of statistical significance.|Kruskal-Wallis|||||||0,001
72609837|NCT03191552|144748447|SUPERIORITY|||||||0.14|||||||Kruskal-Wallis|||||||0.14
72609838|NCT03191552|144748448|SUPERIORITY|||||||0.08|||||||Kruskal-Wallis|||||||0.08
72609839|NCT03191552|144748449|SUPERIORITY|||||||0.314|||||||Wilcoxon (Mann-Whitney)|||||||0.314
72609840|NCT03191552|144748450|SUPERIORITY|||||||0.244|||||||Wilcoxon (Mann-Whitney)|||||||0.244
72609841|NCT03191552|144748451|SUPERIORITY|||||||0.27|||||||Wilcoxon (Mann-Whitney)|||||||0.27
72609842|NCT01149655|144748458|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.461||||0.0161|TWO_SIDED|95.0|0.242|0.879|||Log Rank|The log-rank test was based on time to exacerbation of psychotic symptoms/impending relapse.|Hazard ratios and their 95% confidence intervals were derived from the Cox Proportional Hazard model with treatment as term. Hazard ratio \< 1 is in favor of oral aripiprazole 10-30 mg group for superiority test.|The total number of exacerbation of psychotic symptoms/impending relapse was estimated using a 2:1 (aripiprazole:placebo) randomization ratio to achieve at least 80% power and to preserve an overall nominal alpha level of 0.05 (2-sided).||0.879|0.242|0.0161
72326004|NCT01595529|144175618|SUPERIORITY||Risk Difference (RD)|-0.03056|||||TWO_SIDED|95.0|-0.07744|0.016323||||||||0.016323|-0.07744|
72326005|NCT01595529|144175619|SUPERIORITY||Risk Difference (RD)|-0.01094|||||TWO_SIDED|95.0|-0.058|0.036117||||||||0.036117|-0.0580|
72418080|NCT05338333|144346482|NON_INFERIORITY|Noninferiority in distance VA was declared if the least squares means difference upper confidence limit was less than 0.05.|Least Squares Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.006|||ONE_SIDED|95.0||0.0||Since a noninferiority hypothesis is being tested, a p-value is not applicable. Confidence limit is being reported and compared to the noninferiority margin.|||LSM results based on mixed effects repeated measures model with both fixed (lens, visit, lens-by-visit interaction, period, sequence, and habitual lens stratum) and random (subject) effects. Difference = LID210464 minus AOHG MF.|||0.00||
72326006|NCT01595529|144175620|SUPERIORITY||Risk Difference (RD)|-0.10373|||||TWO_SIDED|95.0|-0.14161|-0.06585||||||||-0.06585|-0.14161|
72326007|NCT01595529|144175621|SUPERIORITY||Risk Difference (RD)|-0.09198|||||TWO_SIDED|95.0|-0.13006|-0.05391||||||||-0.05391|-0.13006|
72609843|NCT01149655|144748460|SUPERIORITY_OR_OTHER|||||||0.0962|TWO_SIDED||||||Chi-squared|p-value was derived using Chi-square test.||Statistical Analysis for Last Visit. The total number of exacerbation of psychotic symptoms/impending relapse was estimated using a 2:1 (aripiprazole:placebo) randomization ratio to achieve at least 80% power and to preserve an overall nominal alpha level of 0.05 (2-sided).||||0.0962
72609844|NCT01149655|144748461|SUPERIORITY_OR_OTHER|||||||0.9025|TWO_SIDED||||||Chi-squared|p-value was derived using Chi-square test.||The expected total number of exacerbation of psychotic symptoms/impending relapse was estimated using a 2:1 (aripiprazole:placebo) randomization ratio to achieve at least 80% power and to preserve an overall nominal alpha level of 0.05 (2-sided).||||0.9025
72609845|NCT01149655|144748462|SUPERIORITY_OR_OTHER|||||||0.0076|TWO_SIDED||||||Log Rank|p-value was derived from the log-rank tests.||The expected total number of exacerbation of psychotic symptoms/impending relapse was estimated using a 2:1 (aripiprazole:placebo) randomization ratio to achieve at least 80% power and to preserve an overall nominal alpha level of 0.05 (2-sided).||||0.0076
72609846|NCT01149655|144748465|SUPERIORITY_OR_OTHER|||||||0.3862|TWO_SIDED||||||Cochran-Mantel-Haenszel|CMH method was based on raw mean score statistics.||Statistical analysis at Baseline. The expected total number of exacerbation of psychotic symptoms/impending relapse was estimated using a 2:1 (aripiprazole:placebo) randomization ratio to achieve at least 80% power and to preserve an overall nominal alpha level of 0.05 (2-sided).||||0.3862
72609847|NCT01149655|144748465|SUPERIORITY_OR_OTHER|||||||0.8861|TWO_SIDED||||||Cochran-Mantel-Haenszel|CMH method was based on raw mean score statistics.||Statistical analysis for Week 1. The expected total number of exacerbation of psychotic symptoms/impending relapse was estimated using a 2:1 (aripiprazole:placebo) randomization ratio to achieve at least 80% power and to preserve an overall nominal alpha level of 0.05 (2-sided).||||0.8861
72609848|NCT01149655|144748465|SUPERIORITY_OR_OTHER|||||||0.8189|TWO_SIDED||||||Cochran-Mantel-Haenszel|CMH method was based on raw mean score statistics.||Statistical analysis for Week 2. The expected total number of exacerbation of psychotic symptoms/impending relapse was estimated using a 2:1 (aripiprazole:placebo) randomization ratio to achieve at least 80% power and to preserve an overall nominal alpha level of 0.05 (2-sided).||||0.8189
72609849|NCT01149655|144748465|SUPERIORITY_OR_OTHER|||||||0.3689|TWO_SIDED||||||Cochran-Mantel-Haenszel|CMH method was based on raw mean score statistics.||Statistical analysis for Week 3. The expected total number of exacerbation of psychotic symptoms/impending relapse was estimated using a 2:1 (aripiprazole:placebo) randomization ratio to achieve at least 80% power and to preserve an overall nominal alpha level of 0.05 (2-sided).||||0.3689
72609850|NCT01149655|144748465|SUPERIORITY_OR_OTHER|||||||0.9723|TWO_SIDED||||||Cochran-Mantel-Haenszel|CMH method was based on raw mean score statistics.||Statistical analysis for Week 4. The expected total number of exacerbation of psychotic symptoms/impending relapse was estimated using a 2:1 (aripiprazole:placebo) randomization ratio to achieve at least 80% power and to preserve an overall nominal alpha level of 0.05 (2-sided).||||0.9723
72609851|NCT01149655|144748465|SUPERIORITY_OR_OTHER|||||||0.2985|TWO_SIDED||||||Cochran-Mantel-Haenszel|CMH method was based on raw mean score statistics.||Statistical analysis for Week 6. The expected total number of exacerbation of psychotic symptoms/impending relapse was estimated using a 2:1 (aripiprazole:placebo) randomization ratio to achieve at least 80% power and to preserve an overall nominal alpha level of 0.05 (2-sided).||||0.2985
72609852|NCT01149655|144748465|SUPERIORITY_OR_OTHER|||||||0.0883|TWO_SIDED||||||Cochran-Mantel-Haenszel|CMH method was based on raw mean score statistics.||Statistical analysis for Week 8. The expected total number of exacerbation of psychotic symptoms/impending relapse was estimated using a 2:1 (aripiprazole:placebo) randomization ratio to achieve at least 80% power and to preserve an overall nominal alpha level of 0.05 (2-sided).||||0.0883
72609853|NCT01149655|144748465|SUPERIORITY_OR_OTHER|||||||0.0228|TWO_SIDED||||||Cochran-Mantel-Haenszel|CMH method was based on raw mean score statistics.||Statistical analysis for Week 10. The expected total number of exacerbation of psychotic symptoms/impending relapse was estimated using a 2:1 (aripiprazole:placebo) randomization ratio to achieve at least 80% power and to preserve an overall nominal alpha level of 0.05 (2-sided).||||0.0228
72609854|NCT01149655|144748465|SUPERIORITY_OR_OTHER|||||||0.0274|TWO_SIDED||||||Cochran-Mantel-Haenszel|CMH method was based on raw mean score statistics.||Statistical analysis for Week 12. The expected total number of exacerbation of psychotic symptoms/impending relapse was estimated using a 2:1 (aripiprazole:placebo) randomization ratio to achieve at least 80% power and to preserve an overall nominal alpha level of 0.05 (2-sided).||||0.0274
72609855|NCT01149655|144748465|SUPERIORITY_OR_OTHER|||||||0.0135|TWO_SIDED||||||Cochran-Mantel-Haenszel|CMH method was based on raw mean score statistics.||Statistical analysis for Week 14. The expected total number of exacerbation of psychotic symptoms/impending relapse was estimated using a 2:1 (aripiprazole:placebo) randomization ratio to achieve at least 80% power and to preserve an overall nominal alpha level of 0.05 (2-sided).||||0.0135
72326008|NCT04016714|144175628|OTHER||Difference in percentage vs Prevenar 13™|-5.5|||=|0.05|TWO_SIDED|95.0|-11.0|0.0|||Miettinen & Nurminen method|||Injection-site erythema||0.0|-11.0|= 0.050
72326009|NCT04016714|144175628|OTHER||Difference in percentage vs Prevenar 13™|-2.1|||=|0.46|TWO_SIDED|95.0|-7.7|3.5|||Miettinen & Nurminen method|||Injection-site induration||3.5|-7.7|= 0.460
72326010|NCT04016714|144175628|OTHER||Difference in percentage vs Prevenar 13™|3.4|||=|0.225|TWO_SIDED|95.0|-2.1|8.9|||Miettinen & Nurminen method|||Injection-site pain||8.9|-2.1|= 0.225
72418081|NCT00677833|144346503|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95 percent (%) confidence interval (CI) for the difference in ACPR (PCR corrected) proportions \[(AZ-CQ)-(AL)\] using the normal approximation to the binomial with continuity correction was constructed based on the estimated ACPR (PCR-corrected) proportions from the Kaplan-Meier curves and their standard errors estimated by the greenwood formula. The drug (AZ-CQ) was considered non-inferior with respect to this primary endpoint if the lower bound of this 95% CI was \>= -10% points.|ACPR percent difference|-9.1|||||TWO_SIDED|95.0|-16.02|-2.18|||Kaplan-Meier curves|||Null hypothesis: proportion of participants with ACPR (PCR-corrected) of Azithromycin/Chloroquine (AZ-CQ) at Day 28 is less than that of Artemether/Lumefantrine (AL); Alternative hypothesis: proportion of participants with ACPR (PCR-corrected) of AZ-CQ at Day 28 is greater than or equal (non-inferior) to that of AL by a non-inferiority margin of -0.1.||-2.18|-16.02|
72552590|NCT03988803|144636000|OTHER||Ratio of the geometric means (T/R1)|94.8|STANDARD_ERROR_OF_MEAN|12.2|||TWO_SIDED|90.0|87.14|103.14|||ANOVA||Standard error of the mean is the geometric coefficient of variation|The statistical model used for the analysis of the primary endpoints was an analysis of variance (ANOVA) model on the logarithmic scale. That was, the PK endpoints were logtransformed (natural logarithm) prior to fitting the ANOVA model. The model used included effects accounting for the following sources of variation: subjects and treatment. The effect 'subjects' was considered as random, whereas the effect 'treatment' was considered as fixed.||103.14|87.14|
72552591|NCT03988803|144636001|OTHER||Ratio of the geometric means (T/R1)|99.34|STANDARD_ERROR_OF_MEAN|12.3|||TWO_SIDED|90.0|91.22|108.18|||ANOVA||Standard error fo the mean is the geometric coefficient of variation|The statistical model used for the analysis of the primary endpoints was an analysis of variance (ANOVA) model on the logarithmic scale. That was, the PK endpoints were logtransformed (natural logarithm) prior to fitting the ANOVA model. The model used included effects accounting for the following sources of variation: subjects and treatment. The effect 'subjects' was considered as random, whereas the effect 'treatment' was considered as fixed.||108.18|91.22|
72609856|NCT01149655|144748465|SUPERIORITY_OR_OTHER|||||||0.0059|TWO_SIDED||||||Cochran-Mantel-Haenszel|CMH method was based on raw mean score statistics.||Statistical analysis for Week 16. The expected total number of exacerbation of psychotic symptoms/impending relapse was estimated using a 2:1 (aripiprazole:placebo) randomization ratio to achieve at least 80% power and to preserve an overall nominal alpha level of 0.05 (2-sided).||||0.0059
72609857|NCT01149655|144748465|SUPERIORITY_OR_OTHER|||||||0.0076|TWO_SIDED||||||Cochran-Mantel-Haenszel|CMH method was based on raw mean score statistics.||Statistical analysis for Week 18. The expected total number of exacerbation of psychotic symptoms/impending relapse was estimated using a 2:1 (aripiprazole:placebo) randomization ratio to achieve at least 80% power and to preserve an overall nominal alpha level of 0.05 (2-sided).||||0.0076
72609858|NCT01149655|144748465|SUPERIORITY_OR_OTHER|||||||0.0065|TWO_SIDED||||||Cochran-Mantel-Haenszel|CMH method was based on raw mean score statistics.||Statistical analysis for Week 20. The expected total number of exacerbation of psychotic symptoms/impending relapse was estimated using a 2:1 (aripiprazole:placebo) randomization ratio to achieve at least 80% power and to preserve an overall nominal alpha level of 0.05 (2-sided).||||0.0065
72609859|NCT01149655|144748465|SUPERIORITY_OR_OTHER|||||||0.0175|TWO_SIDED||||||Cochran-Mantel-Haenszel|CMH method was based on raw mean score statistics.||Statistical analysis for Week 22. The expected total number of exacerbation of psychotic symptoms/impending relapse was estimated using a 2:1 (aripiprazole:placebo) randomization ratio to achieve at least 80% power and to preserve an overall nominal alpha level of 0.05 (2-sided).||||0.0175
72609860|NCT01149655|144748465|SUPERIORITY_OR_OTHER|||||||0.0107|TWO_SIDED||||||Cochran-Mantel-Haenszel|CMH method was based on raw mean score statistics.||Statistical analysis for Week 24. The expected total number of exacerbation of psychotic symptoms/impending relapse was estimated using a 2:1 (aripiprazole:placebo) randomization ratio to achieve at least 80% power and to preserve an overall nominal alpha level of 0.05 (2-sided).||||0.0107
72609861|NCT01149655|144748465|SUPERIORITY_OR_OTHER|||||||0.0118|TWO_SIDED||||||Cochran-Mantel-Haenszel|CMH method was based on raw mean score statistics.||Statistical analysis for Week 26. The expected total number of exacerbation of psychotic symptoms/impending relapse was estimated using a 2:1 (aripiprazole:placebo) randomization ratio to achieve at least 80% power and to preserve an overall nominal alpha level of 0.05 (2-sided).||||0.0118
72609862|NCT01149655|144748465|SUPERIORITY_OR_OTHER|||||||0.0232|TWO_SIDED||||||Cochran-Mantel-Haenszel|CMH method was based on raw mean score statistics.||Statistical analysis for Week 28. The expected total number of exacerbation of psychotic symptoms/impending relapse was estimated using a 2:1 (aripiprazole:placebo) randomization ratio to achieve at least 80% power and to preserve an overall nominal alpha level of 0.05 (2-sided).||||0.0232
72552592|NCT03988803|144636002|OTHER||Ratio of the geometric means (T/R2)|103.69|STANDARD_ERROR_OF_MEAN|5.2|||TWO_SIDED|90.0|99.99|107.52|||ANOVA||Standard error fo the mean is the geometric coefficient of variation|The statistical model used for the analysis of the primary endpoints was an analysis of variance (ANOVA) model on the logarithmic scale. That was, the PK endpoints were logtransformed (natural logarithm) prior to fitting the ANOVA model. The model used included effects accounting for the following sources of variation: subjects and treatment. The effect 'subjects' was considered as random, whereas the effect 'treatment' was considered as fixed.||107.52|99.99|
72326011|NCT04016714|144175628|OTHER||Difference in percentage vs Prevenar 13™|2.3|||=|0.43|TWO_SIDED|95.0|-3.4|7.9|||Miettinen & Nurminen method|||Injection-site swelling||7.9|-3.4|= 0.430
72552593|NCT03988803|144636003|OTHER||Ratio of the geometric means (T/R2)|107.45|STANDARD_ERROR_OF_MEAN|6.5|||TWO_SIDED|90.0|102.66|112.45|||ANOVA||Standard error fo the mean is the geometric coefficient of variation|The statistical model used for the analysis of the primary endpoints was an analysis of variance (ANOVA) model on the logarithmic scale. That was, the PK endpoints were logtransformed (natural logarithm) prior to fitting the ANOVA model. The model used included effects accounting for the following sources of variation: subjects and treatment. The effect 'subjects' was considered as random, whereas the effect 'treatment' was considered as fixed.||112.45|102.66|
72418082|NCT00677833|144346504|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the difference in ACPR (PCR-corrected) proportions \[(AZ-CQ)-(AL)\] using the normal approximation to the binomial with continuity correction was constructed based on the estimated ACPR (PCR-corrected) proportions from the Kaplan-Meier curves and their standard errors estimated by the greenwood formula. The drug (AZ-CQ) was considered non-inferior with respect to this primary endpoint if the lower bound of this 95% CI was \>= -10% points.|ACPR percent difference|-6.08|||||TWO_SIDED|95.0|-12.1|-0.05|||Kaplan-Meier curves|||Null hypothesis: proportion of participants with ACPR (PCR-corrected) of AZ-CQ at Day 28 is less than that of AL; Alternative hypothesis: proportion of participants with ACPR (PCR-corrected) of AZ-CQ at Day 28 is greater than or equal (non-inferior) to that of AL by a non-inferiority margin of -0.1.||-0.05|-12.10|
72418083|NCT00677833|144346505|SUPERIORITY_OR_OTHER||ACPR percent difference|-5.04|||||TWO_SIDED|95.0|-9.93|-0.15|||Kaplan-Meier curves|||A two-sided 95% CI for the difference in ACPR (PCR-corrected) proportions \[(AZ-CQ)-(AL)\] using the normal approximation to the binomial with continuity correction was constructed based on the estimated ACPR proportions from the Kaplan-Meier curves and their standard errors estimated by the greenwood formula. Estimates for Day 7.||-0.15|-9.93|
72326012|NCT04016714|144175629|OTHER||Difference in percentage vs Prevenar 13™|-3.5|||=|0.229|TWO_SIDED|95.0|-9.1|2.2|||Miettinen & Nurminen method|||Decreased appetite||2.2|-9.1|= 0.229
72418084|NCT00677833|144346505|SUPERIORITY_OR_OTHER||ACPR percent difference|-6.74|||||TWO_SIDED|95.0|-12.15|-1.32|||Kaplan-Meier curves|||A two-sided 95% CI for the difference in ACPR (PCR-corrected) proportions \[(AZ-CQ)-(AL)\] using the normal approximation to the binomial with continuity correction was constructed based on the estimated ACPR proportions from the Kaplan-Meier curves and their standard errors estimated by the greenwood formula. Estimates for Day 14.||-1.32|-12.15|
72609863|NCT01149655|144748465|SUPERIORITY_OR_OTHER|||||||0.0337|TWO_SIDED||||||Cochran-Mantel-Haenszel|CMH method was based on raw mean score statistics.||Statistical analysis for Week 30. The expected total number of exacerbation of psychotic symptoms/impending relapse was estimated using a 2:1 (aripiprazole:placebo) randomization ratio to achieve at least 80% power and to preserve an overall nominal alpha level of 0.05 (2-sided).||||0.0337
72609864|NCT01149655|144748465|SUPERIORITY_OR_OTHER|||||||0.0507|TWO_SIDED||||||Cochran-Mantel-Haenszel|CMH method was based on raw mean score statistics.||Statistical analysis for Week 32. The expected total number of exacerbation of psychotic symptoms/impending relapse was estimated using a 2:1 (aripiprazole:placebo) randomization ratio to achieve at least 80% power and to preserve an overall nominal alpha level of 0.05 (2-sided).||||0.0507
72326013|NCT04016714|144175629|OTHER||Difference in percentage vs Prevenar 13™|2.2|||=|0.077|TWO_SIDED|95.0|-0.2|4.7|||Miettinen & Nurminen method|||Irritability||4.7|-0.2|= 0.077
72326014|NCT04016714|144175629|OTHER||Difference in percentage vs Prevenar 13™|-0.6|||=|0.793|TWO_SIDED|95.0|-5.4|4.1|||Miettinen & Nurminen method|||Somnolence||4.1|-5.4|= 0.793
72418085|NCT00677833|144346505|SUPERIORITY_OR_OTHER||ACPR percent difference|-6.78|||||TWO_SIDED|95.0|-12.82|-0.75|||Kaplan-Meier curves|||A two-sided 95% CI for the difference in ACPR (PCR-corrected) proportions \[(AZ-CQ)-(AL)\] using the normal approximation to the binomial with continuity correction was constructed based on the estimated ACPR proportions from the Kaplan-Meier curves and their standard errors estimated by the greenwood formula. Estimates for Day 21.||-0.75|-12.82|
72326015|NCT04016714|144175629|OTHER||Difference in percentage vs Prevenar 13™|-4.6|||=|0.045|TWO_SIDED|95.0|-9.1|-0.1|||Miettinen & Nurminen method|||Urticaria||-0.1|-9.1|= 0.045
72326016|NCT04016714|144175630|OTHER||Difference in percentage vs Prevenar 13™|0.0|||||TWO_SIDED|95.0|-0.9|0.9||||||Vaccine-related SAEs||0.9|-0.9|
72326017|NCT04016714|144175631|NON_INFERIORITY|For the 13 shared serotypes, a conclusion of non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 2-sided 95% confidence interval (CI) for the difference in percentages (V114 - Prevenar 13™) being \>-10 percentage points (1-sided p-value \<0.025).|Percentage point difference|-2.2|||<|0.001|TWO_SIDED|95.0|-4.3|-0.6|||Miettinen & Nurminen method|||Serotype 1||-0.6|-4.3|< 0.001
72609865|NCT01149655|144748465|SUPERIORITY_OR_OTHER|||||||0.0791|TWO_SIDED||||||Cochran-Mantel-Haenszel|CMH method was based on raw mean score statistics.||Statistical analysis for Week 34. The expected total number of exacerbation of psychotic symptoms/impending relapse was estimated using a 2:1 (aripiprazole:placebo) randomization ratio to achieve at least 80% power and to preserve an overall nominal alpha level of 0.05 (2-sided).||||0.0791
72609866|NCT01149655|144748465|SUPERIORITY_OR_OTHER|||||||0.0898|TWO_SIDED||||||Cochran-Mantel-Haenszel|CMH method was based on raw mean score statistics.||Statistical analysis for Week 36. The expected total number of exacerbation of psychotic symptoms/impending relapse was estimated using a 2:1 (aripiprazole:placebo) randomization ratio to achieve at least 80% power and to preserve an overall nominal alpha level of 0.05 (2-sided).||||0.0898
72609867|NCT01149655|144748465|SUPERIORITY_OR_OTHER|||||||0.0686|TWO_SIDED||||||Cochran-Mantel-Haenszel|CMH method was based on raw mean score statistics.||Statistical analysis for Week 38. The expected total number of exacerbation of psychotic symptoms/impending relapse was estimated using a 2:1 (aripiprazole:placebo) randomization ratio to achieve at least 80% power and to preserve an overall nominal alpha level of 0.05 (2-sided).||||0.0686
72609868|NCT01149655|144748465|SUPERIORITY_OR_OTHER|||||||0.0833|TWO_SIDED||||||Cochran-Mantel-Haenszel|CMH method was based on raw mean score statistics.||Statistical analysis for Week 40. The expected total number of exacerbation of psychotic symptoms/impending relapse was estimated using a 2:1 (aripiprazole:placebo) randomization ratio to achieve at least 80% power and to preserve an overall nominal alpha level of 0.05 (2-sided).||||0.0833
72609869|NCT01149655|144748465|SUPERIORITY_OR_OTHER|||||||0.0824|TWO_SIDED||||||Cochran-Mantel-Haenszel|CMH method was based on raw mean score statistics.||Statistical analysis for Week 42. The expected total number of exacerbation of psychotic symptoms/impending relapse was estimated using a 2:1 (aripiprazole:placebo) randomization ratio to achieve at least 80% power and to preserve an overall nominal alpha level of 0.05 (2-sided).||||0.0824
72609870|NCT01149655|144748465|SUPERIORITY_OR_OTHER|||||||0.0686|TWO_SIDED||||||Cochran-Mantel-Haenszel|CMH method was based on raw mean score statistics.||Statistical analysis for Week 44. The expected total number of exacerbation of psychotic symptoms/impending relapse was estimated using a 2:1 (aripiprazole:placebo) randomization ratio to achieve at least 80% power and to preserve an overall nominal alpha level of 0.05 (2-sided).||||0.0686
72609871|NCT01149655|144748465|SUPERIORITY_OR_OTHER|||||||0.0737|TWO_SIDED||||||Cochran-Mantel-Haenszel|CMH method was based on raw mean score statistics.||Statistical analysis for Week 46. The expected total number of exacerbation of psychotic symptoms/impending relapse was estimated using a 2:1 (aripiprazole:placebo) randomization ratio to achieve at least 80% power and to preserve an overall nominal alpha level of 0.05 (2-sided).||||0.0737
72609872|NCT01149655|144748465|SUPERIORITY_OR_OTHER|||||||0.0893|TWO_SIDED||||||Cochran-Mantel-Haenszel|CMH method was based on raw mean score statistics.||Statistical analysis for Week 48. The expected total number of exacerbation of psychotic symptoms/impending relapse was estimated using a 2:1 (aripiprazole:placebo) randomization ratio to achieve at least 80% power and to preserve an overall nominal alpha level of 0.05 (2-sided).||||0.0893
72609873|NCT01149655|144748465|SUPERIORITY_OR_OTHER|||||||0.0706|TWO_SIDED||||||Cochran-Mantel-Haenszel|CMH method was based on raw mean score statistics.||Statistical analysis for Week 50. The expected total number of exacerbation of psychotic symptoms/impending relapse was estimated using a 2:1 (aripiprazole:placebo) randomization ratio to achieve at least 80% power and to preserve an overall nominal alpha level of 0.05 (2-sided).||||0.0706
72609874|NCT01149655|144748465|SUPERIORITY_OR_OTHER|||||||0.0657|TWO_SIDED||||||Cochran-Mantel-Haenszel|CMH method was based on raw mean score statistics.||Statistical analysis for Week 52. The expected total number of exacerbation of psychotic symptoms/impending relapse was estimated using a 2:1 (aripiprazole:placebo) randomization ratio to achieve at least 80% power and to preserve an overall nominal alpha level of 0.05 (2-sided).||||0.0657
72326018|NCT04016714|144175631|NON_INFERIORITY|For the 13 shared serotypes, a conclusion of non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevenar 13™) being \>-10 percentage points (1-sided p-value \<0.025).|Percentage point difference|10.5|||<|0.001|TWO_SIDED|95.0|6.6|14.6|||Miettinen & Nurminen method|||Serotype 3||14.6|6.6|< 0.001
72609875|NCT05079321|144748469|OTHER|||||||0.25|||||||t-test, 2 sided|||||||0.25
72609876|NCT05079321|144748470|OTHER|||||||0.36|||||||t-test, 2 sided|||||||0.36
72609877|NCT05079321|144748471|OTHER|||||||1|||||||t-test, 2 sided|||||||1.0
72609878|NCT05079321|144748472|OTHER|||||||0.06|||||||t-test, 2 sided|||||||0.06
72609879|NCT05079321|144748473|OTHER|||||||0.49|||||||t-test, 2 sided|||||||0.49
72609880|NCT05079321|144748474|OTHER|||||||0.07|||||||t-test, 2 sided|||||||0.07
72609881|NCT05079321|144748475|OTHER|||||||0.33|||||||t-test, 2 sided|||||||0.33
72609882|NCT05079321|144748476|OTHER|||||||0.65|||||||t-test, 2 sided|||||||0.65
72609883|NCT05079321|144748478|OTHER|||||||0.91|||||||t-test, 2 sided|||||||0.91
72609884|NCT05079321|144748479|OTHER|||||||0.71|||||||t-test, 2 sided|||||||0.71
72609885|NCT05079321|144748480|OTHER|||||||0.97|||||||t-test, 2 sided|||||||0.97
72609886|NCT05079321|144748481|OTHER|||||||0.75|||||||Fisher Exact|||||||0.75
72609887|NCT05079321|144748482|OTHER|||||||0.59|||||||Fisher Exact|||||||0.59
72609888|NCT05079321|144748483|OTHER|||||||0.69|||||||Fisher Exact|||||||0.69
72609889|NCT01296412|144748523|NON_INFERIORITY_OR_EQUIVALENCE|The sitagliptin-based treatment paradigm was to be declared non-inferior to the liraglutide-based treatment paradigm in lowering A1C at Week 26 if the upper bound of 95% confidence intervals of between group difference was less than the non-inferiority margin of 0.4%.|Difference in least squares mean|0.09|||||TWO_SIDED|95.0|-0.05|0.23|||ANCOVA|The ANCOVA model included a term for treatment paradigm and a covariate for baseline value.||||0.23|-0.05|
72609890|NCT01296412|144748524|SUPERIORITY_OR_OTHER||Difference in least squares mean|5.9|||||TWO_SIDED|95.0|0.5|11.4|||ANCOVA|The ANCOVA model included a term for treatment paradigm and a covariate for baseline value.||||11.4|0.5|
72609891|NCT01296412|144748525|SUPERIORITY_OR_OTHER||Difference in percent|-9.5|||||TWO_SIDED|95.0|-17.4|-1.5|||Miettinen & Nurminen|||||-1.5|-17.4|
72609892|NCT01296412|144748526|SUPERIORITY_OR_OTHER||Difference in percent|-4.5|||||TWO_SIDED|95.0|-12.7|3.7|||Miettinen & Nurminen|||||3.7|-12.7|
72609893|NCT02160626|144748527|OTHER|||||||0.0003|||||||ANOVA|||||||0.0003
72609894|NCT02160626|144748527|OTHER|||||||0.0001|||||||ANOVA|||||||.0001
72609895|NCT02160626|144748528|OTHER|||||||0.0001|||||||ANCOVA|||mean change from baseline to Visit 8 PLA will be performed using Analysis of Covariance (ANCOVA) with baseline PLA as the covariate.||||0.0001
72326019|NCT04016714|144175631|NON_INFERIORITY|For the 13 shared serotypes, a conclusion of non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevenar 13™) being \>-10 percentage points (1-sided p-value \<0.025).|Percentage point difference|-1.9|||<|0.001|TWO_SIDED|95.0|-4.0|0.0|||Miettinen & Nurminen method|||Serotype 4||0.0|-4.0|< 0.001
72326020|NCT04016714|144175631|NON_INFERIORITY|For the 13 shared serotypes, a conclusion of non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevenar 13™) being \>-10 percentage points (1-sided p-value \<0.025).|Percentage point difference|-0.2|||<|0.001|TWO_SIDED|95.0|-1.4|0.8|||Miettinen & Nurminen method|||Serotype 5||0.8|-1.4|< 0.001
72326021|NCT04016714|144175631|NON_INFERIORITY|For the 13 shared serotypes, a conclusion of non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevenar 13™) being \>-10 percentage points (1-sided p-value \<0.025).|Percentage point difference|-0.2|||<|0.001|TWO_SIDED|95.0|-1.5|1.0|||Miettinen & Nurminen method|||Serotype 6A||1.0|-1.5|< 0.001
72326022|NCT04016714|144175631|NON_INFERIORITY|For the 13 shared serotypes, a conclusion of non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevenar 13™) being \>-10 percentage points (1-sided p-value \<0.025).|Percentage point difference|0.2|||<|0.001|TWO_SIDED|95.0|-1.2|1.5|||Miettinen & Nurminen method|||Serotype 6B||1.5|-1.2|< 0.001
72326023|NCT04016714|144175631|NON_INFERIORITY|For the 13 shared serotypes, a conclusion of non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevenar 13™) being \>-10 percentage points (1-sided p-value \<0.025).|Percentage point difference|0.4|||<|0.001|TWO_SIDED|95.0|-0.4|1.4|||Miettinen & Nurminen method|||Serotype 7F||1.4|-0.4|< 0.001
72326024|NCT04016714|144175631|NON_INFERIORITY|For the 13 shared serotypes, a conclusion of non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevenar 13™) being \>-10 percentage points (1-sided p-value \<0.025).|Percentage point difference|0.2|||<|0.001|TWO_SIDED|95.0|-0.8|1.2|||Miettinen & Nurminen method|||Serotype 9V||1.2|-0.8|< 0.001
72326025|NCT04016714|144175631|NON_INFERIORITY|For the 13 shared serotypes, a conclusion of non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevenar 13™) being \>-10 percentage points (1-sided p-value \<0.025).|Percentage point difference|-0.4|||<|0.001|TWO_SIDED|95.0|-1.7|0.7|||Miettinen & Nurminen method|||Serotype 14||0.7|-1.7|< 0.001
72418086|NCT00677833|144346505|SUPERIORITY_OR_OTHER||ACPR percent difference|-6.92|||||TWO_SIDED|95.0|-14.59|0.76|||Kaplan-Meier curves|||A two-sided 95% CI for the difference in ACPR (PCR-corrected) proportions \[(AZ-CQ)-(AL)\] using the normal approximation to the binomial with continuity correction was constructed based on the estimated ACPR proportions from the Kaplan-Meier curves and their standard errors estimated by the greenwood formula. Estimates for Day 35.||0.76|-14.59|
72418087|NCT00677833|144346505|SUPERIORITY_OR_OTHER||ACPR percent difference|-8.63|||||TWO_SIDED|95.0|-17.08|-0.18|||Kaplan-Meier curves|||A two-sided 95% CI for the difference in ACPR (PCR-corrected) proportions \[(AZ-CQ)-(AL)\] using the normal approximation to the binomial with continuity correction was constructed based on the estimated ACPR proportions from the Kaplan-Meier curves and their standard errors estimated by the greenwood formula. Estimates for Day 42.||-0.18|-17.08|
72326026|NCT04016714|144175631|NON_INFERIORITY|For the 13 shared serotypes, a conclusion of non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevenar 13™) being \>-10 percentage points (1-sided p-value \<0.025).|Percentage point difference|0.4|||<|0.001|TWO_SIDED|95.0|-0.6|1.5|||Miettinen & Nurminen method|||Serotype 18C||1.5|-0.6|< 0.001
72326027|NCT04016714|144175631|NON_INFERIORITY|For the 13 shared serotypes, a conclusion of non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevenar 13™) being \>-10 percentage points (1-sided p-value \<0.025).|Percentage point difference|-0.2|||<|0.001|TWO_SIDED|95.0|-1.3|0.7|||Miettinen & Nurminen method|||Serotype 19A||0.7|-1.3|< 0.001
72326028|NCT04016714|144175631|NON_INFERIORITY|For the 13 shared serotypes, a conclusion of non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevenar 13™) being \>-10 percentage points (1-sided p-value \<0.025).|Percentage point difference|0.2|||<|0.001|TWO_SIDED|95.0|-0.8|1.2|||Miettinen & Nurminen method|||Serotype 19F||1.2|-0.8|< 0.001
72326029|NCT04016714|144175631|NON_INFERIORITY|For the 13 shared serotypes, a conclusion of non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevenar 13™) being \>-10 percentage points (1-sided p-value \<0.025).|Percentage point difference|0.9|||<|0.001|TWO_SIDED|95.0|-1.2|3.0|||Miettinen & Nurminen method|||Serotype 23F||3.0|-1.2|< 0.001
72418088|NCT00677833|144346506|SUPERIORITY_OR_OTHER||ACPR percent difference|-3.63|||||TWO_SIDED|95.0|-8.4|1.14|||Kaplan-Meier, curves|||A two-sided 95% CI for the difference in ACPR (PCR-corrected) proportions \[(AZ-CQ)-(AL)\] using the normal approximation to the binomial with continuity correction was constructed based on the estimated ACPR proportions from the Kaplan-Meier curves and their standard errors estimated by the greenwood formula. Estimates for Day 21.||1.14|-8.40|
72326030|NCT04016714|144175631|SUPERIORITY|For the 2 serotypes unique to V114, a conclusion of superiority of V114 to Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevenar 13™) being \>10 percentage points (1-sided p-value \<0.025).|Percentage point difference|94.0|||<|0.001|TWO_SIDED|95.0|91.6|95.8|||Miettinen & Nurminen method|||Serotype 22F||95.8|91.6|< 0.001
72326031|NCT04016714|144175631|SUPERIORITY|For the 2 serotypes unique to V114, a conclusion of superiority of V114 to Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevenar 13™) being \>10 percentage points (1-sided p-value \<0.025).|Percentage point difference|97.2|||<|0.001|TWO_SIDED|95.0|95.4|98.4|||Miettinen & Nurminen method|||Serotype 33F||98.4|95.4|< 0.001
72326032|NCT04016714|144175632|NON_INFERIORITY|For the 13 shared serotypes, a conclusion of non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevenar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC ratio|0.58|||<|0.001|TWO_SIDED|95.0|0.54|0.63|||t-test, 1 sided|||Serotype 1||0.63|0.54|< 0.001
72326033|NCT04016714|144175632|NON_INFERIORITY|For the 13 shared serotypes, a conclusion of non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevenar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC ratio|1.31|||<|0.001|TWO_SIDED|95.0|1.2|1.43|||t-test, 1 sided|||Serotype 3||1.43|1.20|< 0.001
72326034|NCT04016714|144175632|NON_INFERIORITY|For the 13 shared serotypes, a conclusion of non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevenar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC ratio|0.7|||<|0.001|TWO_SIDED|95.0|0.63|0.78|||t-test, 1 sided|||Serotype 4||0.78|0.63|< 0.001
72326035|NCT04016714|144175632|NON_INFERIORITY|For the 13 shared serotypes, a conclusion of non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevenar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC ratio|0.62|||<|0.001|TWO_SIDED|95.0|0.56|0.68|||t-test, 1 sided|||Serotype 5||0.68|0.56|< 0.001
72326036|NCT04016714|144175632|NON_INFERIORITY|For the 13 shared serotypes, a conclusion of non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevenar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC ratio|0.6|||<|0.001|TWO_SIDED|95.0|0.54|0.67|||t-test, 1 sided|||Serotype 6A||0.67|0.54|< 0.001
72326037|NCT04016714|144175632|NON_INFERIORITY|For the 13 shared serotypes, a conclusion of non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevenar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC ratio|0.89|||<|0.001|TWO_SIDED|95.0|0.79|1.0|||t-test, 1 sided|||Serotype 6B||1.00|0.79|< 0.001
72326038|NCT04016714|144175632|NON_INFERIORITY|For the 13 shared serotypes, a conclusion of non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevenar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC ratio|0.74|||<|0.001|TWO_SIDED|95.0|0.69|0.81|||t-test, 1 sided|||Serotype 7F||0.81|0.69|< 0.001
72326039|NCT04016714|144175632|NON_INFERIORITY|For the 13 shared serotypes, a conclusion of non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevenar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC ratio|0.7|||<|0.001|TWO_SIDED|95.0|0.64|0.76|||t-test, 1 sided|||Serotype 9V||0.76|0.64|< 0.001
72326040|NCT04016714|144175632|NON_INFERIORITY|For the 13 shared serotypes, a conclusion of non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevenar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC ratio|0.78|||<|0.001|TWO_SIDED|95.0|0.7|0.87|||t-test, 1 sided|||Serotype 14||0.87|0.70|< 0.001
72326041|NCT04016714|144175632|NON_INFERIORITY|For the 13 shared serotypes, a conclusion of non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevenar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC ratio|0.85|||<|0.001|TWO_SIDED|95.0|0.77|0.92|||t-test, 1 sided|||Serotype 18C||0.92|0.77|< 0.001
72326042|NCT04016714|144175632|NON_INFERIORITY|For the 13 shared serotypes, a conclusion of non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevenar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC ratio|0.74|||<|0.001|TWO_SIDED|95.0|0.68|0.82|||t-test, 1 sided|||Serotype 19A||0.82|0.68|< 0.001
72326043|NCT04016714|144175632|NON_INFERIORITY|For the 13 shared serotypes, a conclusion of non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevenar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC ratio|0.79|||<|0.001|TWO_SIDED|95.0|0.72|0.87|||t-test, 1 sided|||Serotype 19F||0.87|0.72|< 0.001
72609896|NCT02160626|144748528|OTHER|||||||0.0001|||||||ANCOVA|||mean change from baseline to Visit 8 PLA will be performed using Analysis of Covariance (ANCOVA) with baseline PLA as the covariate.||||0.0001
72609897|NCT02160626|144748529|OTHER|||||||0.0016||||||For all analyses, two-tail alpha will be set to 0.05 with no adjustment for multiple comparisons.|Cochran-Mantel-Haenszel|For all analyses, two-tail alpha will be set to 0.05 with no adjustment for multiple comparisons.||"Secondary efficacy analyses will also be conducted based on the proportion of subjects who have at least 3 of 4 target lesions judged to be clear on the PLA (PLA=0) at Visit 8.~A separate comparison will be made between each active treatment group and the vehicle treatment group using Cochran-Mantel-Haenszel (CMH) tests stratified by site."||||0.0016
72609898|NCT02160626|144748529|OTHER|For all analyses, two-tail alpha will be set to 0.05 with no adjustment for multiple comparisons.||||||0.0004||||||For all analyses, two-tail alpha will be set to 0.05 with no adjustment for multiple comparisons.|Cochran-Mantel-Haenszel|||||||0.0004
72609899|NCT00434252|144748559|SUPERIORITY_OR_OTHER||Difference in survival rates|3.5||||0.5724||95.0|-8.7|15.7|||z-test|z-test using the standard errors computed using Greenwood's method.||||15.7|-8.7|0.5724
72609900|NCT00434252|144748560|SUPERIORITY_OR_OTHER||Difference in event rates|12.2||||0.0982||95.0|-2.3|26.6|||z-test|z-test using the standard errors computed using Greenwood's method||||26.6|-2.3|0.0982
72609901|NCT02807259|144748562|EQUIVALENCE|Power calculations did not account for stratification used in the randomisation or include adjustment for baseline levels of the outcome, since the correlation over time was not known. Results suggested that the trial had \>80% power to detect a risk ratio of 0.77, if the coefficient of between-cluster variation was between 0.15 and 0.25.|Odds Ratio (OR)|1.47||||0.298|TWO_SIDED|95.0|0.71|3.01|||Mixed Models Analysis|||Power calculations were conducted assuming an IPV prevalence (past 12 months) of 47% and consistent condom use (past 12 months) of 38% based on initial assessments. The power calculation was performed by analysing simulated data from 800 women, distributed across clusters using empirical data with a range in variance across cluster-level proportions of IPV (15% to 25% of the total variation) and a narrow range of effect sizes (risk ratio= 0.75-0.80).||3.01|0.71|0.298
72609902|NCT02807259|144748563|OTHER||Odds Ratio (OR)|1.38||||0.378|TWO_SIDED|95.0|0.68|2.81|||Mixed Models Analysis|||||2.81|0.68|0.378
72609903|NCT02807259|144748564|OTHER||Odds Ratio (OR)|0.93||||0.748|TWO_SIDED|95.0|0.58|1.47|||Mixed Models Analysis|||||1.47|0.58|0.748
72609904|NCT02807259|144748565|OTHER||Odds Ratio (OR)|0.62||||0.025|TWO_SIDED|95.0|0.4|0.94|||Mixed Models Analysis|||||0.94|0.4|0.025
72609905|NCT02807259|144748566|OTHER||Odds Ratio (OR)|2.07||||0.372|TWO_SIDED|95.0|0.42|10.26|||Mixed Models Analysis|||||10.26|0.42|0.372
72609906|NCT02807259|144748567|OTHER||Odds Ratio (OR)|0.96||||0.845|TWO_SIDED|95.0|0.61|1.5|||Mixed Models Analysis|||||1.50|0.61|0.845
72609907|NCT02807259|144748568|OTHER||Odds Ratio (OR)|1.69||||0.042|TWO_SIDED|95.0|1.02|2.82|||Mixed Models Analysis|||||2.82|1.02|0.042
72609908|NCT00737178|144748582|SUPERIORITY_OR_OTHER||||||<|0.01|||||||Chi-squared|||||||<.01
72609909|NCT00737178|144748584|SUPERIORITY_OR_OTHER|||||||0.24||95.0|||||Chi-squared|||||||0.24
72609910|NCT00485836|144748592|SUPERIORITY_OR_OTHER||Difference in Least Squares means|11.5|||<|0.0001||95.0|7.7|15.3||The Hochberg-Bonferroni multiple comparison procedure was used to adjust for comparisons of the two ranibizumab groups with the sham-injection group to maintain an overall type I error rate of 0.05.|ANOVA|Stratified by baseline visual acuity score (≤ 34, 35-54, ≥ 55 letters).||||15.3|7.7|<0.0001
72609911|NCT00485836|144748592|SUPERIORITY_OR_OTHER||Difference in Least Squares means|13.8|||<|0.0001||95.0|10.3|17.4||The Hochberg-Bonferroni multiple comparison procedure was used to adjust for comparisons of the two ranibizumab groups with the sham-injection group to maintain an overall type I error rate of 0.05.|ANOVA|Stratified by baseline visual acuity score (≤ 34, 35-54, ≥ 55 letters).||||17.4|10.3|<0.0001
72609912|NCT00485836|144748593|SUPERIORITY_OR_OTHER||Difference in percentage|29.3|||<|0.0001||95.0|18.8|39.7|||Cochran-Mantel-Haenszel χ²|Stratified by baseline visual acuity score (≤ 34, 35-54, ≥ 55 letters).|Weighted estimates adjusted for baseline visual acuity score (≤ 34, 35-54, ≥ 55 letters) using Cochran-Mantel-Haenszel weights.|||39.7|18.8|<0.0001
72609913|NCT00485836|144748593|SUPERIORITY_OR_OTHER||Difference in percentage|30.3|||<|0.0001||95.0|19.6|40.9|||Cochran-Mantel-Haenszel χ²|Stratified by baseline visual acuity score (≤ 34, 35-54, ≥ 55 letters).|Weighted estimates adjusted for baseline visual acuity score (≤ 34, 35-54, ≥ 55 letters) using Cochran-Mantel-Haenszel weights.|||40.9|19.6|<0.0001
72609914|NCT00485836|144748594|SUPERIORITY_OR_OTHER||Difference in percentage|11.3||||0.0019||95.0|4.3|18.2|||Cochran-Mantel-Haenszel χ²|Stratified by baseline visual acuity score (≤ 34, 35-54, ≥ 55 letters).|Weighted estimates adjusted for baseline visual acuity score (≤ 34, 35-54, ≥ 55 letters) using Cochran-Mantel-Haenszel weights.|||18.2|4.3|0.0019
72609915|NCT00485836|144748594|SUPERIORITY_OR_OTHER||Difference in percentage|13.6|||<|0.0001||95.0|7.2|20.1|||Cochran-Mantel-Haenszel χ²|Stratified by baseline visual acuity score (≤ 34, 35-54, ≥ 55 letters).|Weighted estimates adjusted for baseline visual acuity score (≤ 34, 35-54, ≥ 55 letters) using Cochran-Mantel-Haenszel weights.|||20.1|7.2|<0.0001
72609916|NCT00485836|144748595|SUPERIORITY_OR_OTHER||Difference in percentage|51.9|||<|0.0001||95.0|41.6|62.3|||Cochran-Mantel-Haenszel χ²|Stratified by baseline visual acuity score (≤ 34, 35-54, ≥ 55 letters).|Weighted estimates adjusted for baseline visual acuity score (≤ 34, 35-54, ≥ 55 letters) using Cochran-Mantel-Haenszel weights.|||62.3|41.6|<0.0001
72609917|NCT00485836|144748595|SUPERIORITY_OR_OTHER||Difference in percentage|54.0|||<|0.0001||95.0|44.0|64.1|||Cochran-Mantel-Haenszel χ²|Stratified by baseline visual acuity score (≤ 34, 35-54, ≥ 55 letters).|Weighted estimates adjusted for baseline visual acuity score (≤ 34, 35-54, ≥ 55 letters) using Cochran-Mantel-Haenszel weights.|||64.1|44.0|<0.0001
72609918|NCT00485836|144748596|SUPERIORITY_OR_OTHER||Difference in Least Squares means|-272.2|||<|0.0001||95.0|-329.9|-214.5|||ANCOVA|Pairwise ANCOVA models adjusted for baseline visual acuity score (≤ 34, 35-54, ≥ 55 letters) and baseline value of central foveal thickness.||||-214.5|-329.9|<0.0001
72609919|NCT00485836|144748596|SUPERIORITY_OR_OTHER||Difference in Least Squares means|-283.8|||<|0.0001||95.0|-337.8|-229.8|||ANCOVA|Pairwise ANCOVA models adjusted for baseline visual acuity score (≤ 34, 35-54, ≥ 55 letters) and baseline value of central foveal thickness.||||-229.8|-337.8|<0.0001
72609920|NCT00485836|144748597|SUPERIORITY_OR_OTHER||Difference in Least Squares means|5.8||||0.0019||95.0|2.1|9.4|||ANCOVA|Pairwise ANCOVA models adjusted for baseline visual acuity score (≤ 34, 35-54, ≥ 55 letters) and baseline Near Activities Subscale score.||||9.4|2.1|0.0019
72609921|NCT00485836|144748597|SUPERIORITY_OR_OTHER||Difference in Least Squares means|4.9||||0.0099||95.0|1.2|8.6|||ANCOVA|Pairwise ANCOVA models adjusted for baseline visual acuity score (≤ 34, 35-54, ≥ 55 letters) and baseline Near Activities Subscale score.||||8.6|1.2|0.0099
72326044|NCT04016714|144175632|NON_INFERIORITY|For the 13 shared serotypes, a conclusion of non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevenar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC ratio|0.9|||<|0.001|TWO_SIDED|95.0|0.81|1.0|||t-test, 1 sided|||Serotype 23F||1.00|0.81|< 0.001
72326045|NCT04016714|144175632|SUPERIORITY|For the 2 serotypes unique to V114, a conclusion of superiority of V114 to Prevenar 13™ is based on the lower bound of the 2- sided 95% CI for the GMC ratio (V114/Prevenar 13™) being \>2.0 (1-sided p-value \<0.025).|GMC ratio|68.34|||<|0.001|TWO_SIDED|95.0|61.73|75.65|||t-test, 1 sided|||Serotype 22F||75.65|61.73|< 0.001
72326046|NCT04016714|144175632|SUPERIORITY|For the 2 serotypes unique to V114, a conclusion of superiority of V114 to Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevenar 13™) being \>2.0 (1-sided p-value \<0.025).|GMC ratio|48.99|||<|0.001|TWO_SIDED|95.0|44.45|54.01|||t-test, 1 sided|||Serotype 33F||54.01|44.45|< 0.001
72326047|NCT04016714|144175633|NON_INFERIORITY|A conclusion of non-inferiority of Vaxelis™ administered concomitantly with V114 to Vaxelis™ administered concomitantly with Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevenar 13™) being greater than the specified non-inferiority margin (1-sided p-value \<0.025).|Percentage point difference|0.2|||<|0.001|TWO_SIDED|95.0|-0.6|1.0|||Miettinen & Nurminen method|||Diphtheria toxoid||1.0|-0.6|< 0.001
72326048|NCT04016714|144175633|NON_INFERIORITY|A conclusion of non-inferiority of Vaxelis™ administered concomitantly with V114 to Vaxelis™ administered concomitantly with Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevenar 13™) being greater than the specified non-inferiority margin (1-sided p-value \<0.025).|Percentage point difference|0.2|||<|0.001|TWO_SIDED|95.0|-0.6|1.0|||Miettinen & Nurminen method|||Tetanus toxoid||1.0|-0.6|< 0.001
72326049|NCT04016714|144175633|NON_INFERIORITY|A conclusion of non-inferiority of Vaxelis™ administered concomitantly with V114 to Vaxelis™ administered concomitantly with Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevenar 13™) being greater than the specified non-inferiority margin (1-sided p-value \<0.025).|Percentage point difference|0.2|||<|0.001|TWO_SIDED|95.0|-0.6|1.0|||Miettinen & Nurminen method|||Pertussis - PT||1.0|-0.6|< 0.001
72326050|NCT04016714|144175633|NON_INFERIORITY|A conclusion of non-inferiority of Vaxelis™ administered concomitantly with V114 to Vaxelis™ administered concomitantly with Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevenar 13™) being greater than the specified non-inferiority margin (1-sided p-value \<0.025).|Percentage point difference|0.2|||<|0.001|TWO_SIDED|95.0|-0.6|1.0|||Miettinen & Nurminen method|||Pertussis - FHA||1.0|-0.6|< 0.001
72326051|NCT04016714|144175633|NON_INFERIORITY|A conclusion of non-inferiority of Vaxelis™ administered concomitantly with V114 to Vaxelis™ administered concomitantly with Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevenar 13™) being greater than the specified non-inferiority margin (1-sided p-value \<0.025).|Percentage point difference|0.2|||<|0.001|TWO_SIDED|95.0|-0.8|1.2|||Miettinen & Nurminen method|||Pertussis - FIM 2/3||1.2|-0.8|< 0.001
72326052|NCT04016714|144175633|NON_INFERIORITY|A conclusion of non-inferiority of Vaxelis™ administered concomitantly with V114 to Vaxelis™ administered concomitantly with Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevenar 13™) being greater than the specified non-inferiority margin (1-sided p-value \<0.025).|Percentage point difference|0.2|||<|0.001|TWO_SIDED|95.0|-0.8|1.2|||Miettinen & Nurminen method|||Pertussis - PRN||1.2|-0.8|< 0.001
72326053|NCT04016714|144175633|NON_INFERIORITY|A conclusion of non-inferiority of Vaxelis™ administered concomitantly with V114 to Vaxelis™ administered concomitantly with Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevenar 13™) being greater than the specified non-inferiority margin (1-sided p-value \<0.025).|Percentage point difference|-1.1|||<|0.001|TWO_SIDED|95.0|-3.3|0.9|||Miettinen & Nurminen method|||Hib-PRP||0.9|-3.3|< 0.001
72326054|NCT04016714|144175633|NON_INFERIORITY|A conclusion of non-inferiority of Vaxelis™ administered concomitantly with V114 to Vaxelis™ administered concomitantly with Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevenar 13™) being greater than the specified non-inferiority margin (1-sided p-value \<0.025).|Percentage point difference|-0.6|||<|0.001|TWO_SIDED|95.0|-2.0|0.5|||Miettinen & Nurminen method|||HBsAg||0.5|-2.0|< 0.001
72326055|NCT04016714|144175633|NON_INFERIORITY|A conclusion of non-inferiority of Vaxelis™ administered concomitantly with V114 to Vaxelis™ administered concomitantly with Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevenar 13™) being greater than the specified non-inferiority margin (1-sided p-value \<0.025).|Percentage point difference|0.0|||<|0.001|TWO_SIDED|95.0|-0.9|0.9|||Miettinen & Nurminen method|||Poliovirus 1||0.9|-0.9|< 0.001
72326056|NCT04016714|144175633|NON_INFERIORITY|A conclusion of non-inferiority of Vaxelis™ administered concomitantly with V114 to Vaxelis™ administered concomitantly with Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevenar 13™) being greater than the specified non-inferiority margin (1-sided p-value \<0.025).|Percentage point difference|0.2|||<|0.001|TWO_SIDED|95.0|-0.6|1.1|||Miettinen & Nurminen method|||Poliovirus 2||1.1|-0.6|< 0.001
72326057|NCT04016714|144175633|NON_INFERIORITY|A conclusion of non-inferiority of Vaxelis™ administered concomitantly with V114 to Vaxelis™ administered concomitantly with Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevenar 13™) being greater than the specified non-inferiority margin (1-sided p-value \<0.025).|Percentage point difference|0.0|||<|0.001|TWO_SIDED|95.0|-0.8|0.7|||Miettinen & Nurminen method|||Poliovirus 3||0.7|-0.8|< 0.001
72326058|NCT04016714|144175635|OTHER||GMC ratio|0.82|||||TWO_SIDED|95.0|0.75|0.89||||||Serotype 1||0.89|0.75|
72326059|NCT04016714|144175635|OTHER||GMC ratio|1.81|||||TWO_SIDED|95.0|1.66|1.98||||||Serotype 3||1.98|1.66|
72326060|NCT04016714|144175635|OTHER||GMC ratio|1.09|||||TWO_SIDED|95.0|0.99|1.21||||||Serotype 4||1.21|0.99|
72326061|NCT04016714|144175635|OTHER||GMC ratio|0.91|||||TWO_SIDED|95.0|0.81|1.01||||||Serotype 5||1.01|0.81|
72326062|NCT04016714|144175635|OTHER||GMC ratio|0.44|||||TWO_SIDED|95.0|0.38|0.5||||||Serotype 6A||0.50|0.38|
72326063|NCT04016714|144175635|OTHER||GMC ratio|1.73|||||TWO_SIDED|95.0|1.46|2.05||||||Serotype 6B||2.05|1.46|
72326064|NCT04016714|144175635|OTHER||GMC ratio|0.78|||||TWO_SIDED|95.0|0.71|0.84||||||Serotype 7F||0.84|0.71|
72326065|NCT04016714|144175635|OTHER||GMC ratio|1.0|||||TWO_SIDED|95.0|0.9|1.12||||||Serotype 9V||1.12|0.90|
72326066|NCT04016714|144175635|OTHER||GMC ratio|1.02|||||TWO_SIDED|95.0|0.89|1.18||||||Serotype 14||1.18|0.89|
72326067|NCT04016714|144175635|OTHER||GMC ratio|0.75|||||TWO_SIDED|95.0|0.68|0.82||||||Serotype 18C||0.82|0.68|
72326068|NCT04016714|144175635|OTHER||GMC ratio|0.72|||||TWO_SIDED|95.0|0.64|0.81||||||Serotype 19A||0.81|0.64|
72326069|NCT04016714|144175635|OTHER||GMC ratio|0.69|||||TWO_SIDED|95.0|0.62|0.77||||||Serotype 19F||0.77|0.62|
72326070|NCT04016714|144175635|OTHER||GMC ratio|1.32|||||TWO_SIDED|95.0|1.16|1.51||||||Serotype 23F||1.51|1.16|
72609922|NCT00485836|144748598|SUPERIORITY_OR_OTHER||Difference in Least Squares means|6.3||||0.0002||95.0|3.1|9.5|||ANCOVA|Pairwise ANCOVA models adjusted for baseline visual acuity score (≤ 34, 35-54, ≥ 55 letters) and baseline Distance Activities Subscale score.||||9.5|3.1|0.0002
72609923|NCT00485836|144748598|SUPERIORITY_OR_OTHER||Difference in Least Squares means|4.1||||0.0199||95.0|0.7|7.6|||ANCOVA|Pairwise ANCOVA models adjusted for baseline visual acuity score (≤ 34, 35-54, ≥ 55 letters) and baseline Distance Activities Subscale score.||||7.6|0.7|0.0199
72609924|NCT01949545|144748599|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|144.43||||0.02232|TWO_SIDED|95.0|111.48|187.12|||ANOVA||The geometric mean ratio was calculated by exponentiation of the differences in the least squares means, using log-transformed data, between the hepatic impairment cohort (test) and participants with normal hepatic function (reference).|To assess the effect of hepatic impairment relative to participants with normal hepatic function on AUC0-last an analysis of variance (ANOVA) of the log-transformed plasma PK parameters was performed. The ANOVA model included hepatic impairment as a fixed effect.||187.12|111.48|0.02232
72609925|NCT01949545|144748599|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|126.08||||0.1812|TWO_SIDED|95.0|94.59|168.06|||ANOVA||The geometric mean ratio was calculated by exponentiation of the differences in the least squares means, using log-transformed data, between the hepatic impairment cohort (test) and participants with normal hepatic function (reference).|To assess the effect of hepatic impairment relative to participants with normal hepatic function on AUC0-last an ANOVA of the log-transformed plasma PK parameters was performed. The ANOVA model included hepatic impairment as a fixed effect.||168.06|94.59|0.1812
72326071|NCT04016714|144175635|SUPERIORITY||GMC ratio|81.01|||||TWO_SIDED|95.0|73.12|89.75||||||Serotype 22F||89.75|73.12|
72326072|NCT04016714|144175635|OTHER||GMC ratio|7.81|||||TWO_SIDED|95.0|6.82|8.94||||||Serotype 33F||8.94|6.82|
72326073|NCT02358993|144175638|NON_INFERIORITY|Non-inferiority of the primary outcome was achieved if the lower limit of the 95% confidence interval of the mean difference was greater than the specified non-inferiority margin of 15%(a clinically relevant margin within the range of those commonly used in non-inferiority and equivalence trials for studies examining antibiotic use for UTI)|Risk Ratio (RR)|-0.01|||||TWO_SIDED|95.0||||||||||||
72326074|NCT04067492|144175722|OTHER|"The study was planned to randomize 85 patients: 15 patients in the RPH-104 4 mg group, and 14 patients in the RPH-104 20 mg, 40 mg, 80 mg and 160 mg groups each, a total of 14 patients in the Voltaren® (diclofenac) group.~The sample size was calculated assuming a standard deviation of 26 mm for change in pain intensity at 72 hours."|Mean Difference (Final Values)|28.63||||0.1331|TWO_SIDED|95.0|4.21|53.05||p-value, group|ANCOVA||Adjusted mean difference. Comparison with the control group \[RPH-104 - Diclofenac\].|It was assumed that the sample size would allow constructing a 95% CI around the mean change in pain intensity at 72 hours after the start of the investigational product use in each group with an accuracy of 30 mm change in pain intensity and would reveal statistically significant differences between the groups in pairwise comparisons, without control for type I error for multiple comparisons, taking into account the type I error α = 5%, if the difference between the compared groups is ≥ 20 mm.||53.05|4.21|0.1331
72326075|NCT04067492|144175722|OTHER|"The study was planned to randomize 85 patients: 15 patients in the RPH-104 4 mg group, and 14 patients in the RPH-104 20 mg, 40 mg, 80 mg and 160 mg groups each, a total of 14 patients in the Voltaren® (diclofenac) group.~The sample size was calculated assuming a standard deviation of 26 mm for change in pain intensity at 72 hours."|Mean Difference (Final Values)|-2.05||||0.1331|TWO_SIDED|95.0|-30.6|26.5||p-value, group|ANCOVA||Adjusted mean difference. Comparison with the control group \[RPH-104 - Diclofenac\].|It was assumed that the sample size would allow constructing a 95% CI around the mean change in pain intensity at 72 hours after the start of the investigational product use in each group with an accuracy of 30 mm change in pain intensity and would reveal statistically significant differences between the groups in pairwise comparisons, without control for type I error for multiple comparisons, taking into account the type I error α = 5%, if the difference between the compared groups is ≥ 20 mm.||26.50|-30.60|0.1331
72326076|NCT04067492|144175722|OTHER|"The study was planned to randomize 85 patients: 15 patients in the RPH-104 4 mg group, and 14 patients in the RPH-104 20 mg, 40 mg, 80 mg and 160 mg groups each, a total of 14 patients in the Voltaren® (diclofenac) group.~The sample size was calculated assuming a standard deviation of 26 mm for change in pain intensity at 72 hours."|Mean Difference (Final Values)|16.7||||0.1331|TWO_SIDED|95.0|-12.67|46.08||p-value, group|ANCOVA||Adjusted mean difference. Comparison with the control group \[RPH-104 - Diclofenac\].|It was assumed that the sample size would allow constructing a 95% CI around the mean change in pain intensity at 72 hours after the start of the investigational product use in each group with an accuracy of 30 mm change in pain intensity and would reveal statistically significant differences between the groups in pairwise comparisons, without control for type I error for multiple comparisons, taking into account the type I error α = 5%, if the difference between the compared groups is ≥ 20 mm.||46.08|-12.67|0.1331
72609926|NCT01949545|144748600|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|151.84||||0.02137|TWO_SIDED|95.0|113.59|202.96|||ANOVA||The geometric mean ratio was calculated by exponentiation of the differences in the least squares means, using log-transformed data, between the hepatic impairment cohort (test) and participants with normal hepatic function (reference).|To assess the effect of hepatic impairment relative to participants with normal hepatic function on AUC0-inf an ANOVA of the log-transformed plasma PK parameters was performed. The ANOVA model included hepatic impairment as a fixed effect.||202.96|113.59|0.02137
72418089|NCT00677833|144346506|SUPERIORITY_OR_OTHER||ACPR percent difference|-3.87|||||TWO_SIDED|95.0|-10.79|3.04|||Kaplan-Meier, curves|||A two-sided 95% CI for the difference in ACPR (PCR-corrected) proportions \[(AZ-CQ)-(AL)\] using the normal approximation to the binomial with continuity correction was constructed based on the estimated ACPR proportions from the Kaplan-Meier curves and their standard errors estimated by the greenwood formula. Estimates for Day 35.||3.04|-10.79|
72418090|NCT00677833|144346506|SUPERIORITY_OR_OTHER||ACPR percent difference|-5.66|||||TWO_SIDED|95.0|-13.55|2.22|||Kaplan-Meier, curves|||A two-sided 95% CI for the difference in ACPR (PCR-corrected) proportions \[(AZ-CQ)-(AL)\] using the normal approximation to the binomial with continuity correction was constructed based on the estimated ACPR proportions from the Kaplan-Meier curves and their standard errors estimated by the greenwood formula. Estimates for Day 42.||2.22|-13.55|
72418091|NCT00677833|144346507|SUPERIORITY_OR_OTHER||ACPR percent difference|-5.04|||||TWO_SIDED|95.0|-9.93|-0.15|||Kaplan-Meier curves|||A two-sided 95% CI for the difference in ACPR (PCR-uncorrected) proportions \[(AZ-CQ)-(AL)\] using the normal approximation to the binomial with continuity correction was constructed based on the estimated ACPR proportions from the Kaplan-Meier curves and their standard errors estimated by the greenwood formula. Estimates for Day 7.||-0.15|-9.93|
72418092|NCT00677833|144346507|SUPERIORITY_OR_OTHER||ACPR percent difference|-7.71|||||TWO_SIDED|95.0|-14.54|-0.88|||Kaplan-Meier curves|||A two-sided 95% CI for the difference in ACPR (PCR-uncorrected) proportions \[(AZ-CQ)-(AL)\] using the normal approximation to the binomial with continuity correction was constructed based on the estimated ACPR proportions from the Kaplan-Meier curves and their standard errors estimated by the greenwood formula. Estimates for Day 14.||-0.88|-14.54|
72418093|NCT00677833|144346507|SUPERIORITY_OR_OTHER||ACPR percent difference|-15.09|||||TWO_SIDED|95.0|-26.24|-3.94|||Kaplan-Meier curves|||A two-sided 95% CI for the difference in ACPR (PCR-uncorrected) proportions \[(AZ-CQ)-(AL)\] using the normal approximation to the binomial with continuity correction was constructed based on the estimated ACPR proportions from the Kaplan-Meier curves and their standard errors estimated by the greenwood formula. Estimates for Day 21.||-3.94|-26.24|
72418094|NCT00677833|144346507|SUPERIORITY_OR_OTHER||ACPR percent difference|-21.76|||||TWO_SIDED|95.0|-34.14|-9.39|||Kaplan-Meier curves|||A two-sided 95% CI for the difference in ACPR (PCR-uncorrected) proportions \[(AZ-CQ)-(AL)\] using the normal approximation to the binomial with continuity correction was constructed based on the estimated ACPR proportions from the Kaplan-Meier curves and their standard errors estimated by the greenwood formula. Estimates for Day 28.||-9.39|-34.14|
72418095|NCT00677833|144346507|SUPERIORITY_OR_OTHER||ACPR percent difference|-18.24|||||TWO_SIDED|95.0|-31.05|-5.43|||Kaplan-Meier curves|||A two-sided 95% CI for the difference in ACPR (PCR-uncorrected) proportions \[(AZ-CQ)-(AL)\] using the normal approximation to the binomial with continuity correction was constructed based on the estimated ACPR proportions from the Kaplan-Meier curves and their standard errors estimated by the greenwood formula. Estimates for Day 35.||-5.43|-31.05|
72418096|NCT00677833|144346507|SUPERIORITY_OR_OTHER||ACPR Percent difference|-18.49|||||TWO_SIDED|95.0|-31.33|-5.65|||Kaplan-Meier curves|||A two-sided 95% CI for the difference in ACPR (PCR-uncorrected) proportions \[(AZ-CQ)-(AL)\] using the normal approximation to the binomial with continuity correction was constructed based on the estimated ACPR proportions from the Kaplan-Meier curves and their standard errors estimated by the greenwood formula. Estimates for Day 42.||-5.65|-31.33|
72609927|NCT01949545|144748600|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|143.53||||0.07247|TWO_SIDED|95.0|103.28|199.45|||ANOVA||The geometric mean ratio was calculated by exponentiation of the differences in the least squares means, using log-transformed data, between the hepatic impairment cohort (test) and participants with normal hepatic function (reference).|To assess the effect of hepatic impairment relative to participants with normal hepatic function on AUC0-inf an ANOVA of the log-transformed plasma PK parameters was performed. The ANOVA model included hepatic impairment as a fixed effect.||199.45|103.28|0.07247
72609928|NCT00427934|144748661|SUPERIORITY_OR_OTHER||Percentage Difference|-1.73||||0.79||90.0|-15.13|8.68|||Barnard/Pearson chi-square test||Percentage Difference = maraviroc responders divided by the number of maraviroc participants analyzed minus placebo responders divided by the number of placebo participants analyzed.|Week 1||8.68|-15.13|0.790
72609929|NCT00427934|144748661|SUPERIORITY_OR_OTHER||Percentage Difference|0.43||||0.477||90.0|-13.67|11.64|||Barnard/Pearson chi-square test||Percentage Difference = maraviroc responders divided by the number of maraviroc participants analyzed minus placebo responders divided by the number of placebo participants analyzed.|Week 2||11.64|-13.67|0.477
72609930|NCT00427934|144748661|SUPERIORITY_OR_OTHER||Percentage Difference|3.03||||0.37||90.0|-12.85|16.77|||Barnard/Pearson chi-square test||Percentage Difference = maraviroc responders divided by the number of maraviroc participants analyzed minus placebo responders divided by the number of placebo participants analyzed.|Week 4||16.77|-12.85|0.370
72609931|NCT00427934|144748661|SUPERIORITY_OR_OTHER||Percentage Difference|8.66||||0.175||90.0|-7.07|22.03|||Barnard/Pearson chi-square test||Percentage Difference = maraviroc responders divided by the number of maraviroc participants analyzed minus placebo responders divided by the number of placebo participants analyzed.|Week 8||22.03|-7.07|0.175
72326077|NCT04067492|144175722|OTHER|"The study was planned to randomize 85 patients: 15 patients in the RPH-104 4 mg group, and 14 patients in the RPH-104 20 mg, 40 mg, 80 mg and 160 mg groups each, a total of 14 patients in the Voltaren® (diclofenac) group.~The sample size was calculated assuming a standard deviation of 26 mm for change in pain intensity at 72 hours."|Mean Difference (Final Values)|3.12||||0.1331|TWO_SIDED|95.0|-25.1|31.33||p-value, group|ANCOVA||Adjusted mean difference. Comparison with the control group \[RPH-104 - Diclofenac\]|It was assumed that the sample size would allow constructing a 95% CI around the mean change in pain intensity at 72 hours after the start of the investigational product use in each group with an accuracy of 30 mm change in pain intensity and would reveal statistically significant differences between the groups in pairwise comparisons, without control for type I error for multiple comparisons, taking into account the type I error α = 5%, if the difference between the compared groups is ≥ 20 mm.||31.33|-25.10|0.1331
72326078|NCT04067492|144175722|OTHER|"The study was planned to randomize 85 patients: 15 patients in the RPH-104 4 mg group, and 14 patients in the RPH-104 20 mg, 40 mg, 80 mg and 160 mg groups each, a total of 14 patients in the Voltaren® (diclofenac) group.~The sample size was calculated assuming a standard deviation of 26 mm for change in pain intensity at 72 hours."|Mean Difference (Final Values)|5.96||||0.1331|TWO_SIDED|95.0|-24.22|36.14||p-value, group|ANCOVA||Adjusted mean difference. Comparison with the control group \[RPH-104 - Diclofenac\].|It was assumed that the sample size would allow constructing a 95% CI around the mean change in pain intensity at 72 hours after the start of the investigational product use in each group with an accuracy of 30 mm change in pain intensity and would reveal statistically significant differences between the groups in pairwise comparisons, without control for type I error for multiple comparisons, taking into account the type I error α = 5%, if the difference between the compared groups is ≥ 20 mm.||36.14|-24.22|0.1331
72326079|NCT04067492|144175729|OTHER|||||||0.5995|||||||Log Rank|||||||0.5995
72326080|NCT04067492|144175729|OTHER|||||||0.9012|||||||Log Rank|||||||0.9012
72326081|NCT04067492|144175731|OTHER||difference in proportions|63.5||||0.0066|TWO_SIDED|95.0|19.9|88.6|||Fisher Exact|||||88.6|19.9|0.0066
72326082|NCT04067492|144175731|OTHER||difference in proportions|-5.6|||>|0.9999|TWO_SIDED|95.0|-50.1|45.5|||Fisher Exact|||||45.5|-50.1|>0.9999
72326083|NCT04067492|144175731|OTHER||difference in proportions|27.8||||0.3287|TWO_SIDED|95.0|-26.8|71.8|||Fisher Exact|||||71.8|-26.8|0.3287
72326084|NCT04067492|144175731|OTHER||difference in proportions|27.8||||0.3287|TWO_SIDED|95.0|-26.8|71.8|||Fisher Exact|||||71.8|-26.8|0.3287
72326085|NCT04067492|144175731|OTHER||difference in proportions|17.8||||0.5804|TWO_SIDED|95.0|-33.7|67.8|||Fisher Exact|||||67.8|-33.7|0.5804
72418097|NCT00677833|144346508|SUPERIORITY_OR_OTHER||ACPR percent difference|-4.67|||||TWO_SIDED|95.0|-10.6|1.25|||Kaplan-Meier curves|||A two-sided 95% CI for the difference in ACPR (PCR-uncorrected) proportions \[(AZ-CQ)-(AL)\] using the normal approximation to the binomial with continuity correction was constructed based on the estimated ACPR proportions from the Kaplan-Meier curves and their standard errors estimated by the greenwood formula. Estimates for Day 14.||1.25|-10.60|
72418098|NCT00677833|144346508|SUPERIORITY_OR_OTHER||ACPR percent difference|-13.07|||||TWO_SIDED|95.0|-24.21|-1.92|||Kaplan-Meier curves|||A two-sided 95% CI for the difference in ACPR (PCR-uncorrected) proportions \[(AZ-CQ)-(AL)\] using the normal approximation to the binomial with continuity correction was constructed based on the estimated ACPR proportions from the Kaplan-Meier curves and their standard errors estimated by the greenwood formula. Estimates for Day 21.||-1.92|-24.21|
72326086|NCT00833027|144175753|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.6|STANDARD_DEVIATION|0.85|<|0.001|ONE_SIDED|95.0|||||Student's T-test|Student's T-test for paired samples||||||<0.001
72326087|NCT00553410|144175767|SUPERIORITY||Hazard Ratio (HR)|1.08||||0.31|TWO_SIDED|95.0|0.93|1.26|||Log Rank|||||1.26|.93|.31
72326088|NCT00553410|144175768|SUPERIORITY||Hazard Ratio (HR)|0.85||||0.16|TWO_SIDED|95.0|0.68|1.06|||Log Rank|||||1.06|.68|.16
72326089|NCT00553410|144175769|SUPERIORITY||Hazard Ratio (HR)|0.88||||0.25|TWO_SIDED|95.0|0.71|1.09|||Log Rank|||||1.09|.71|.25
72326090|NCT00553410|144175770|SUPERIORITY||Hazard Ratio (HR)|0.98||||0.84|TWO_SIDED|95.0|0.81|1.18|||Log Rank|||||1.18|.81|.84
72326091|NCT04683913|144175778|OTHER||||||<|0.001|||||||ANCOVA|alpha=0.05||||||<0.001
72326092|NCT04683913|144175779|OTHER|||||||0.027||||||Week 1\&2 vs Week 3\&4|t-test, 2 sided|alpha corrected with Bonferroni-Dunn procedure (k=10).||The change in foot progression angle magnitude at each sequential time point were compared using paired t-tests (with a Bonferroni-Dunn correction). Results indicate whether the change from baseline were significantly different at each time point. Abbreviations: F=Follow up, R=Retention||||0.027
72326093|NCT04683913|144175779|OTHER|||||||1||||||Week 3\&4 vs Week 5\&6|t-test, 2 sided|||The change in foot progression angle magnitude at each sequential time point were compared using paired t-tests (with a Bonferroni-Dunn correction). Results indicate whether the change from baseline were significantly different at each time point. Abbreviations: F=Follow up, R=Retention||||1.0
72326094|NCT04683913|144175779|OTHER|||||||0.078||||||Week 5\&6 vs Follow up|t-test, 2 sided|alpha corrected with Bonferroni-Dunn procedure (k=10).||The change in foot progression angle magnitude at each sequential time point were compared using paired t-tests (with a Bonferroni-Dunn correction). Results indicate whether the change from baseline were significantly different at each time point. Abbreviations: F=Follow up, R=Retention||||0.078
72326095|NCT04683913|144175779|OTHER|||||||0.015||||||Follow up vs Retention|t-test, 2 sided|alpha corrected with Bonferroni-Dunn procedure (k=10).||The change in foot progression angle magnitude at each sequential time point were compared using paired t-tests (with a Bonferroni-Dunn correction). Results indicate whether the change from baseline were significantly different at each time point. Abbreviations: F=Follow up, R=Retention||||0.015
72418099|NCT00677833|144346508|SUPERIORITY_OR_OTHER||ACPR percent difference|-19.62|||||TWO_SIDED|95.0|-32.16|-7.08|||Kaplan-Meier curves|||A two-sided 95% CI for the difference in ACPR (PCR-uncorrected) proportions \[(AZ-CQ)-(AL)\] using the normal approximation to the binomial with continuity correction was constructed based on the estimated ACPR proportions from the Kaplan-Meier curves and their standard errors estimated by the greenwood formula. Estimates for Day 28.||-7.08|-32.16|
72418100|NCT00677833|144346508|SUPERIORITY_OR_OTHER||ACPR percent difference|-16.38|||||TWO_SIDED|95.0|-29.42|-3.33|||Kaplan-Meier curves|||A two-sided 95% CI for the difference in ACPR (PCR-uncorrected) proportions \[(AZ-CQ)-(AL)\] using the normal approximation to the binomial with continuity correction was constructed based on the estimated ACPR proportions from the Kaplan-Meier curves and their standard errors estimated by the greenwood formula. Estimates for Day 35.||-3.33|-29.42|
72418101|NCT00677833|144346508|SUPERIORITY_OR_OTHER||ACPR Percent difference|-16.94|||||TWO_SIDED|95.0|-30.04|-3.83|||Kaplan-Meier curves|||A two-sided 95% CI for the difference in ACPR (PCR-uncorrected) proportions \[(AZ-CQ)- (AL)\] using the normal approximation to the binomial with continuity correction was constructed based on the estimated ACPR proportions from the Kaplan-Meier curves and their standard errors estimated by the Greenwood formula. Estimates for Day 42.||-3.83|-30.04|
72418102|NCT00677833|144346515|SUPERIORITY_OR_OTHER||percent difference|-5.89|||||TWO_SIDED|95.0|-11.02|-0.75|||large sample approximation to binomial|||Day 7||-0.75|-11.02|
72418103|NCT00677833|144346515|SUPERIORITY_OR_OTHER||percent difference|-7.55|||||TWO_SIDED|95.0|-13.14|-1.95|||large sample approximation to binomial|||Day 14||-1.95|-13.14|
72418104|NCT00677833|144346515|SUPERIORITY_OR_OTHER||percent difference|-7.6|||||TWO_SIDED|95.0|-13.61|-1.6|||large sample approximation to binomial|||Day 21||-1.60|-13.61|
72609932|NCT00427934|144748662|SUPERIORITY_OR_OTHER||Percentage Difference|1.3||||0.42||90.0|-6.34|6.01|||Barnard/Pearson chi-square test||Percentage Difference = maraviroc responders divided by the number of maraviroc participants analyzed minus placebo responders divided by the number of placebo participants analyzed.|Week 1||6.01|-6.34|0.420
72418105|NCT00677833|144346515|SUPERIORITY_OR_OTHER||percent difference|-9.26|||||TWO_SIDED|95.0|-15.64|-2.87|||Large sample approximation to binomial|||Day 28||-2.87|-15.64|
72418106|NCT00677833|144346515|SUPERIORITY_OR_OTHER||percent difference|-7.71|||||TWO_SIDED|95.0|-14.45|-0.97|||Large sample approximation to binomial|||Day 35||-0.97|-14.45|
72418107|NCT00677833|144346515|SUPERIORITY_OR_OTHER||percent difference|-8.52|||||TWO_SIDED|95.0|-15.43|-1.6|||Large sample approximation to binomial|||Day 42||-1.60|-15.43|
72418108|NCT00677833|144346516|SUPERIORITY_OR_OTHER||percent difference|-9.51|||||TWO_SIDED|95.0|-18.27|-0.74|||Large sample approximation to binomial|||Day 7||-0.74|-18.27|
72418109|NCT00677833|144346516|SUPERIORITY_OR_OTHER||percent difference|-10.39|||||TWO_SIDED|95.0|-19.23|-1.55|||Large sample approximation to binomial|||Day 14||-1.55|-19.23|
72418110|NCT00677833|144346516|SUPERIORITY_OR_OTHER||percent difference|-12.75|||||TWO_SIDED|95.0|-21.45|-4.04|||Large sample approximation to binomial|||Day 21||-4.04|-21.45|
72418111|NCT00677833|144346516|SUPERIORITY_OR_OTHER||percent difference|-11.11|||||TWO_SIDED|95.0|-19.62|-2.6|||Large sample approximation to binomial|||Day 28||-2.60|-19.62|
72418112|NCT00677833|144346516|SUPERIORITY_OR_OTHER||percent difference|-10.34|||||TWO_SIDED|95.0|-18.97|-1.71|||Large sample approximation to binomial|||Day 35||-1.71|-18.97|
72418113|NCT00677833|144346516|SUPERIORITY_OR_OTHER||percent difference|-11.21|||||TWO_SIDED|95.0|-20.14|-2.28|||Large sample approximation to binomial|||Day 42||-2.28|-20.14|
72418114|NCT00677833|144346517|SUPERIORITY_OR_OTHER|||||||0.2564|TWO_SIDED||||||Kaplan-Meier, log rank|||Time to event data was analyzed using the Kaplan-Meier curve.||||0.2564
72418115|NCT00677833|144346518|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Kaplan-Meier, log rank|||Time to event data was analyzed using the Kaplan-Meier curve.||||<0.0001
72418116|NCT00677833|144346521|SUPERIORITY_OR_OTHER|||||||0.0006|TWO_SIDED||||||Kaplan-Meier, log rank|||Time to event data was analyzed using the Kaplan-Meier curve.||||0.0006
72418117|NCT05072457|144346524|OTHER||||||<|0.05|||||||ANOVA|||"MANOVA analysis with independent variable being the intervention condition (type of microphone used) and dependent variable being the performance on lateralization task.~Null hypothesis: There will be no statistically significant difference in lateralization test scores between the Roger On and the Roger Select in the experimental group."||||<.05
72609933|NCT00427934|144748662|SUPERIORITY_OR_OTHER||Percentage Difference|2.6||||0.258||90.0|-5.08|7.95|||Barnard/Pearson chi-square test||Percentage Difference = maraviroc responders divided by the number of maraviroc participants analyzed minus placebo responders divided by the number of placebo participants analyzed.|Week 2||7.95|-5.08|0.258
72609934|NCT00427934|144748662|SUPERIORITY_OR_OTHER||Percentage Difference|-3.46||||1||90.0|-14.39|3.42|||Barnard/Pearson chi-square test||Percentage Difference = maraviroc responders divided by the number of maraviroc participants analyzed minus placebo responders divided by the number of placebo participants analyzed.|Week 4||3.42|-14.39|1.000
72609935|NCT00427934|144748662|SUPERIORITY_OR_OTHER||Percentage Difference|-1.3||||0.899||90.0|-13.56|7.92|||Barnard/Pearson chi-square test||Percentage Difference = maraviroc responders divided by the number of maraviroc participants analyzed minus placebo responders divided by the number of placebo participants analyzed.|Week 8||7.92|-13.56|0.899
72609936|NCT00427934|144748662|SUPERIORITY_OR_OTHER||Percentage Difference|1.3||||0.489||90.0|-11.24|10.96|||Barnard/Pearson chi-square test||Percentage Difference = maraviroc responders divided by the number of maraviroc participants analyzed minus placebo responders divided by the number of placebo participants analyzed.|Week 12||10.96|-11.24|0.489
72609937|NCT00427934|144748663|SUPERIORITY_OR_OTHER||Percentage Difference|-3.03||||1||90.0|-13.59|1.28|||Barnard/Pearson chi-square test||Percentage Difference = maraviroc responders divided by the number of maraviroc participants analyzed minus placebo responders divided by the number of placebo participants analyzed.|Week 4||1.28|-13.59|1.000
72609938|NCT00427934|144748663|SUPERIORITY_OR_OTHER||Percentage Difference|2.6||||0.258||90.0|-5.08|7.95|||Barnard/Pearson chi-square test||Percentage Difference = maraviroc responders divided by the number of maraviroc participants analyzed minus placebo responders divided by the number of placebo participants analyzed.|Week 8||7.95|-5.08|0.258
72609939|NCT00427934|144748663|SUPERIORITY_OR_OTHER||Percentage Difference|-3.03||||1||90.0|-13.59|1.28|||Barnard/Pearson chi-square test||Percentage Difference = maraviroc responders divided by the number of maraviroc participants analyzed minus placebo responders divided by the number of placebo participants analyzed.|Week 12||1.28|-13.59|1.000
72609940|NCT00427934|144748664|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.1||||0.335||90.0|-0.79|2.99||This analysis was carried out using analysis of covariance (ANCOVA) with baseline tender/painful joint count as the covariate, treatment, region as fixed effects.|ANCOVA|||Week 1||2.99|-0.79|0.335
72609941|NCT00427934|144748664|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3||||0.816||90.0|-1.82|2.41||This analysis was carried out using ANCOVA with baseline tender/painful joint count as the covariate, treatment, region as fixed effects.|ANCOVA|||Week 2||2.41|-1.82|0.816
72609942|NCT00427934|144748664|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.01||||0.996||90.0|-2.35|2.36||This analysis was carried out using ANCOVA with baseline tender/painful joint count as the covariate, treatment, region as fixed effects.|ANCOVA|||Week 4||2.36|-2.35|0.996
72326096|NCT04683913|144175779|OTHER|||||||0.567||||||Week 1\&2 vs Week 5\&6|t-test, 2 sided|alpha corrected with Bonferroni-Dunn procedure (k=10).||The change in foot progression angle magnitude at each sequential time point were compared using paired t-tests (with a Bonferroni-Dunn correction). Results indicate whether the change from baseline were significantly different at each time point. Abbreviations: F=Follow up, R=Retention||||0.567
72326097|NCT04683913|144175779|OTHER|||||||0.001||||||Week 1\&2 vs Follow up|t-test, 2 sided|alpha corrected with Bonferroni-Dunn procedure (k=10).||The change in foot progression angle magnitude at each sequential time point were compared using paired t-tests (with a Bonferroni-Dunn correction). Results indicate whether the change from baseline were significantly different at each time point. Abbreviations: F=Follow up, R=Retention||||0.001
72326098|NCT04683913|144175779|OTHER|||||||1||||||Week 1\&2 vs Retention|t-test, 2 sided|alpha corrected with Bonferroni-Dunn procedure (k=10).||The change in foot progression angle magnitude at each sequential time point were compared using paired t-tests (with a Bonferroni-Dunn correction). Results indicate whether the change from baseline were significantly different at each time point. Abbreviations: F=Follow up, R=Retention||||1.0
72326099|NCT04683913|144175779|OTHER|||||||0.205||||||Week 3\&4 vs Follow up|t-test, 2 sided|alpha corrected with Bonferroni-Dunn procedure (k=10).||The change in foot progression angle magnitude at each sequential time point were compared using paired t-tests (with a Bonferroni-Dunn correction). Results indicate whether the change from baseline were significantly different at each time point. Abbreviations: F=Follow up, R=Retention||||0.205
72326100|NCT04683913|144175779|OTHER|||||||0.162||||||Week 3\&4 vs Retention|t-test, 2 sided|alpha corrected with Bonferroni-Dunn procedure (k=10).||The change in foot progression angle magnitude at each sequential time point were compared using paired t-tests (with a Bonferroni-Dunn correction). Results indicate whether the change from baseline were significantly different at each time point. Abbreviations: F=Follow up, R=Retention||||0.162
72326101|NCT04683913|144175779|OTHER|||||||0.421||||||Week 5\&6 vs Retention|t-test, 2 sided|alpha corrected with Bonferroni-Dunn procedure (k=10).||The change in foot progression angle magnitude at each sequential time point were compared using paired t-tests (with a Bonferroni-Dunn correction). Results indicate whether the change from baseline were significantly different at each time point. Abbreviations: F=Follow up, R=Retention||||0.421
72326102|NCT04683913|144175784|SUPERIORITY|||||||0.75|||||||ANCOVA|Controlling for baseline scores, structural severity and sex. alpha=0.05||Knee Injury and Osteoarthritis Outcome Scale - pain subscale scores were compared between the delayed and immediate groups at week 6 using ANCOVA.||||0.750
72609943|NCT00427934|144748664|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.61||||0.263||90.0|-3.98|0.76||This analysis was carried out using ANCOVA with baseline tender/painful joint count as the covariate, treatment, region as fixed effects.|ANCOVA|||Week 8||0.76|-3.98|0.263
72326103|NCT04683913|144175784|SUPERIORITY|||||||0.201|||||||ANCOVA|Controlling for baseline scores, structural severity and sex. alpha=0.05||Knee Injury and Osteoarthritis Outcome Scale - stiffness subscale scores were compared between the delayed and immediate groups at week 6 using ANCOVA.||||0.201
72326104|NCT04683913|144175784|SUPERIORITY|||||||0.997|||||||ANCOVA|Controlling for baseline scores, structural severity and sex. alpha=0.05||Knee Injury and Osteoarthritis Outcome Scale - physical function subscale scores were compared between the delayed and immediate groups at week 6 using ANCOVA.||||0.997
72326105|NCT04683913|144175784|SUPERIORITY|||||||0.423|||||||ANCOVA|Controlling for baseline scores, structural severity and sex. alpha=0.05||Knee Injury and Osteoarthritis Outcome Scale - quality of life subscale scores were compared between the delayed and immediate groups at week 6 using ANCOVA.||||0.423
72326106|NCT04683913|144175785|SUPERIORITY|||||||0.342|||||||ANCOVA|Controlling for body mass, structural severity and sex. alpha=0.05||Knee adduction moment 1 (early stance) was analyzed as raw Nm with body mass entered as as covariate.||||0.342
72326107|NCT04683913|144175785|SUPERIORITY|||||||0.844|||||||ANCOVA|Controlling for body mass, structural severity and sex. alpha=0.05||Knee Adduction Moment 2 (late stance was analyzed as raw Nm with body mass entered as as covariate.||||0.844
72326108|NCT04683913|144175785|SUPERIORITY|||||||0.774|||||||ANCOVA|Controlling for body mass, structural severity and sex. alpha=0.05||Knee Flexion Moments were analyzed as raw Nm with body mass entered as as covariate||||0.774
72326109|NCT04683913|144175786|SUPERIORITY|||||||0.186|||||||ANCOVA|Controlling for body mass, structural severity and sex. alpha=0.05||Knee adduction moment impulses were analyzed as raw Nm\*s with body mass entered as as covariate.||||0.186
72326110|NCT04683913|144175786|SUPERIORITY|||||||0.601|||||||ANCOVA|Controlling for body mass, structural severity and sex. alpha=0.05||Knee flexion moment impulses were analyzed as raw Nm\*s with body mass entered as as covariate.||||0.601
72326111|NCT00543985|144175787|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|-0.266|||=|0.14|TWO_SIDED|95.0|||||Regression, Linear|||Pearson Product correlation was used to determine relationships between resting E/E' and Exercise VO2 max and Stress E/E' and Exercise VO2max.||||=0.14
72326112|NCT00237042|144175791|SUPERIORITY_OR_OTHER|||||||0.19||95.0|||||Regression, Linear|Linear regression was used to compare group means at follow up, adjusted for baseline values of the outcome variable.||The null hypothesis was that mean characteristic pain intensity at 6-month follow up is equal across the three groups.||||0.19
72326113|NCT00237042|144175792|SUPERIORITY_OR_OTHER|||||||0.27||95.0|||||Regression, Logistic|Adjusted for baseline value of the outcome variable||||||0.27
72326114|NCT00237042|144175793|SUPERIORITY_OR_OTHER|||||||0.003||95.0|||||Regression, Linear|Group means compared with linear regression adjusted for baseline values. Adjusted difference: -1.0 between SMT and COCT, -1.0 between TSMT and COCT.||The null hypothesis was that mean characteristic pain intensity at 12-month follow up is equal across the three groups.||||0.003
72326115|NCT00237042|144175794|SUPERIORITY_OR_OTHER|||||||0.016||95.0|||||Regression, Logistic|Adjusted for baseline value of the outcome variable||||||0.016
72418118|NCT05072457|144346525|OTHER||||||>|0.05|||||||ANOVA|||Independent variable: intervention condition (type of microphone used), Dependent variable: performance on spatial hearing task. Null hypothesis: There will be no statistically significant difference in spatial hearing test scores between the Roger On and the Roger Select in the experimental group.||||>.05
72609944|NCT00427934|144748664|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.48||||0.294||90.0|-3.82|0.85||This analysis was carried out using ANCOVA with baseline tender/painful joint count as the covariate, treatment, region as fixed effects.|ANCOVA|||Week 12||0.85|-3.82|0.294
72609945|NCT00427934|144748665|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.32||||0.7||90.0|-1.7|1.06||This analysis was carried out using ANCOVA baseline swollen joint count as the covariate, treatment, region as fixed effects.|ANCOVA|||Week 1||1.06|-1.70|0.700
72609946|NCT00427934|144748665|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.26||||0.799||90.0|-1.45|1.97||This analysis was carried out using ANCOVA baseline swollen joint count as the covariate, treatment, region as fixed effects.|ANCOVA|||Week 2||1.97|-1.45|0.799
72609947|NCT00427934|144748665|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.15||||0.867||90.0|-1.35|1.66||This analysis was carried out using ANCOVA baseline swollen joint count as the covariate, treatment, region as fixed effects.|ANCOVA|||Week 4||1.66|-1.35|0.867
72609948|NCT00427934|144748665|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.45||||0.167||90.0|-3.17|0.28||This analysis was carried out using ANCOVA baseline swollen joint count as the covariate, treatment, region as fixed effects.|ANCOVA|||Week 8||0.28|-3.17|0.167
72609949|NCT00427934|144748665|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.05||||0.966||90.0|-1.91|1.81||This analysis was carried out using ANCOVA baseline swollen joint count as the covariate, treatment, region as fixed effects.|ANCOVA|||Week 12||1.81|-1.91|0.966
72609950|NCT00427934|144748666|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.34||||0.925||90.0|-6.41|5.72||This analysis was carried out using ANCOVA with baseline patient's assessment of arthritis pain as the covariate, treatment, region as fixed effects.|ANCOVA|||Week 1||5.72|-6.41|0.925
72609951|NCT00427934|144748666|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.26||||0.239||90.0|-12.62|2.11||This analysis was carried out using ANCOVA with baseline patient's assessment of arthritis pain as the covariate, treatment, region as fixed effects.|ANCOVA|||Week 2||2.11|-12.62|0.239
72609952|NCT00427934|144748666|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.73||||0.872||90.0|-6.79|8.25||This analysis was carried out using ANCOVA with baseline patient's assessment of arthritis pain as the covariate, treatment, region as fixed effects.|ANCOVA|||Week 4||8.25|-6.79|0.872
72609953|NCT00427934|144748666|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.63||||0.745||90.0|-9.91|6.65||This analysis was carried out using ANCOVA with baseline patient's assessment of arthritis pain as the covariate, treatment, region as fixed effects.|ANCOVA|||Week 8||6.65|-9.91|0.745
72418119|NCT02623322|144346574|SUPERIORITY||Difference in event rates (Wald)|-3.03||||0.3031|TWO_SIDED|80.0|-12.25|6.19|||Cochran-Mantel-Haenszel|||||6.19|-12.25|0.3031
72609954|NCT00427934|144748666|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.22||||0.644||90.0|-10.14|5.71||This analysis was carried out using ANCOVA with baseline patient's assessment of arthritis pain as the covariate, treatment, region as fixed effects.|ANCOVA|||Week 12||5.71|-10.14|0.644
72609955|NCT00427934|144748667|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.36||||0.524||90.0|-8.49|3.77||This analysis was carried out using ANCOVA with baseline Patient's Global Assessment of Arthritis as the covariate, treatment, region as fixed effects.|ANCOVA|||Week 1||3.77|-8.49|0.524
72609956|NCT00427934|144748667|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.96||||0.338||90.0|-10.8|2.87||This analysis was carried out using ANCOVA with baseline Patient's Global Assessment of Arthritis as the covariate, treatment, region as fixed effects.|ANCOVA|||Week 2||2.87|-10.80|0.338
72609957|NCT00427934|144748667|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.98||||0.83||90.0|-8.55|6.58||This analysis was carried out using ANCOVA with baseline Patient's Global Assessment of Arthritis as the covariate, treatment, region as fixed effects.|ANCOVA|||Week 4||6.58|-8.55|0.830
72609958|NCT00427934|144748667|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.68||||0.118||90.0|-15.76|0.4||This analysis was carried out using ANCOVA with baseline Patient's Global Assessment of Arthritis as the covariate, treatment, region as fixed effects.|ANCOVA|||Week 8||0.40|-15.76|0.118
72609959|NCT00427934|144748667|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.78||||0.712||90.0|-9.73|6.18||This analysis was carried out using ANCOVA with baseline Patient's Global Assessment of Arthritis as the covariate, treatment, region as fixed effects.|ANCOVA|||Week 12||6.18|-9.73|0.712
72609960|NCT00427934|144748668|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.08||||0.54||90.0|-0.28|0.13||This analysis was carried out using ANCOVA with baseline Physician's Global Assessment of Arthritis as the covariate, treatment, region as fixed effects.|ANCOVA|||Week 1||0.13|-0.28|0.540
72609961|NCT00427934|144748668|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.04||||0.757||90.0|-0.28|0.19||This analysis was carried out using ANCOVA with baseline Physician's Global Assessment of Arthritis as the covariate, treatment, region as fixed effects.|ANCOVA|||Week 2||0.19|-0.28|0.757
72609962|NCT00427934|144748668|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.05||||0.767||90.0|-0.31|0.21||This analysis was carried out using ANCOVA with baseline Physician's Global Assessment of Arthritis as the covariate, treatment, region as fixed effects.|ANCOVA|||Week 4||0.21|-0.31|0.767
72609963|NCT00427934|144748668|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.26||||0.112||90.0|-0.52|0.01||This analysis was carried out using ANCOVA with baseline Physician's Global Assessment of Arthritis as the covariate, treatment, region as fixed effects.|ANCOVA|||Week 8||0.01|-0.52|0.112
72609964|NCT00427934|144748668|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.13||||0.49||90.0|-0.42|0.17||This analysis was carried out using ANCOVA with baseline Physician's Global Assessment of Arthritis as the covariate, treatment, region as fixed effects.|ANCOVA|||Week 12||0.17|-0.42|0.490
72609965|NCT00427934|144748669|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.06||||0.464||90.0|-0.19|0.07||This analysis was carried out using ANCOVA with HAQ-DI as the covariate, treatment, region as fixed effects.|ANCOVA|||Week 1||0.07|-0.19|0.464
72609966|NCT00427934|144748669|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.18||||0.068||90.0|-0.35|-0.02||This analysis was carried out using ANCOVA with HAQ-DI as the covariate, treatment, region as fixed effects.|ANCOVA|||Week 2||-0.02|-0.35|0.068
72609967|NCT00427934|144748669|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.06||||0.532||90.0|-0.23|0.11||This analysis was carried out using ANCOVA with HAQ-DI as the covariate, treatment, region as fixed effects.|ANCOVA|||Week 4||0.11|-0.23|0.532
72609968|NCT00427934|144748669|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.22||||0.063||90.0|-0.41|-0.03||This analysis was carried out using ANCOVA with HAQ-DI as the covariate, treatment, region as fixed effects.|ANCOVA|||Week 8||-0.03|-0.41|0.063
72609969|NCT00427934|144748669|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.12||||0.396||90.0|-0.36|0.12||This analysis was carried out using ANCOVA with HAQ-DI as the covariate, treatment, region as fixed effects.|ANCOVA|||Week 12||0.12|-0.36|0.396
72609970|NCT00427934|144748670|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.2||||0.481||90.0|-7.36|2.96||This analysis was carried out using ANCOVA with CRP as the covariate, treatment, region as fixed effects.|ANCOVA|||Week 1||2.96|-7.36|0.481
72609971|NCT00427934|144748670|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.33||||0.698||90.0|-4.34|6.99||This analysis was carried out using ANCOVA with CRP as the covariate, treatment, region as fixed effects.|ANCOVA|||Week 2||6.99|-4.34|0.698
72418120|NCT02623322|144346574|SUPERIORITY||Difference in event rates (Wald)|-3.03||||0.3324|TWO_SIDED|80.0|-12.82|6.76|||Cochran-Mantel-Haenszel|||||6.76|-12.82|0.3324
72418121|NCT02623322|144346575|SUPERIORITY||Difference in event rates (Wald)|-3.03||||0.3031|TWO_SIDED|80.0|-12.25|6.19|||Cochran-Mantel-Haenszel|||||6.19|-12.25|0.3031
72418122|NCT02623322|144346575|SUPERIORITY||Difference in event rates (Wald)|-3.03||||0.3324|TWO_SIDED|80.0|-12.82|6.76|||Cochran-Mantel-Haenszel|||||6.76|-12.82|0.3324
72418123|NCT02623322|144346579|SUPERIORITY||Hazard Ratio (HR)|0.92||||0.7858|TWO_SIDED|80.0|0.62|1.37|||Wilcoxon|||Total Symptom Score of \<=1||1.37|0.62|0.7858
72418124|NCT02623322|144346579|SUPERIORITY||Hazard Ratio (HR)|0.9||||0.517|TWO_SIDED|80.0|0.59|1.36|||Wilcoxon|||Total Symptom Score of \<=1||1.36|0.59|0.5170
72418125|NCT02623322|144346579|SUPERIORITY||Hazard Ratio (HR)|0.63||||0.0312|TWO_SIDED|80.0|0.45|0.89|||Wilcoxon|||Total Symptom Score of \<=7||0.89|0.45|0.0312
72418126|NCT02623322|144346579|SUPERIORITY||Hazard Ratio (HR)|0.74||||0.2044|TWO_SIDED|80.0|0.53|1.04|||Wilcoxon|||Total Symptom Score of \<=7||1.04|0.53|0.2044
72418127|NCT03775200|144346581|OTHER|For this primary analysis, a sample size of 216 randomised participants (72:72:72) will provide 90% power at the alpha = 0.05 level to detect a 6-point difference in average MADRS total score between the optimal therapeutic dose of COMP360 and COMP360 1 mg, assuming the common standard deviation (SD) is 11.0.|Least Mean Square Difference|-6.6|STANDARD_ERROR_OF_MEAN|1.86|<|0.05|TWO_SIDED|95.0|-10.2|-2.9|||Mixed Models Analysis|Hypothetical strategy estimand - missing not at random (MNAR) and missing at random (MAR) imputation for missing data.|LSM difference of COMP360 25 mg compared to COMP360 1 mg.|The primary analysis was the comparison between COMP360 (25 mg or 10 mg) versus COMP360 1 mg. The null hypothesis was that there was no difference in mean change from Baseline in MADRS total score at Week 3 for COMP360 25 mg or COMP360 10 mg versus COMP360 1 mg. The alternative hypothesis was that were was a difference in mean change from Baseline in MADRS total score at Week 3 for COMP360 25 mg or COMP360 10 mg versus COMP360 1 mg.||-2.9|-10.2|<0.05
72418128|NCT03775200|144346582|OTHER||Least Mean Square Difference|-5.6|STANDARD_ERROR_OF_MEAN|1.93|<|0.05|TWO_SIDED|95.0|-9.4|-1.8|||Mixed Models Analysis|Hypothetical strategy estimand - MNAR and MAR imputation for missing data.||Sensitivity analysis of the primary endpoint using the per-protocol analysis set.||-1.8|-9.4|<0.05
72609972|NCT00427934|144748670|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.65||||0.233||90.0|-1.79|11.1||This analysis was carried out using ANCOVA with CRP as the covariate, treatment, region as fixed effects.|ANCOVA|||Week 4||11.10|-1.79|0.233
72609973|NCT00427934|144748670|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.48||||0.32||90.0|-2.29|9.25||This analysis was carried out using ANCOVA with CRP as the covariate, treatment, region as fixed effects.|ANCOVA|||Week 8||9.25|-2.29|0.320
72418129|NCT05159622|144346585|EQUIVALENCE|A net effect of 6 fluid oz/day (SD=1) was hypothesized among adult parents, assuming two sided alpha=0.05, power = 80%, and a minimum sample size of 60 adults.|Median Difference (Final Values)|3.2||||0.15|TWO_SIDED|||||The a priori threshold for statistical significance is \<0.05. P-value of the interaction between treatment group and change in beverage consumption (fl oz/day).|t-test, 2 sided|||||||0.15
72418130|NCT05159622|144346586|EQUIVALENCE|This was an exploratory outcome.|Median Difference (Final Values)|0.07||||0.98|TWO_SIDED||||||t-test, 2 sided|||||||0.98
72418131|NCT05159622|144346587|EQUIVALENCE|This was an exploratory outcome and therefore statistical power was not based on a hypothesis of this outcome.|Median Difference (Final Values)|0.64||||0.36|TWO_SIDED||||||t-test, 2 sided|||||||0.36
72418132|NCT05159622|144346588|EQUIVALENCE|Exploratory outcome as for infants/toddlers based on parent-report|Median Difference (Final Values)|0.14||||0.92|TWO_SIDED||||||t-test, 2 sided|||||||0.92
72418133|NCT05159622|144346589|EQUIVALENCE|Exploratory outcome|Median Difference (Final Values)|0.95||||0.03|TWO_SIDED||||||t-test, 2 sided|||||||0.03
72418134|NCT03318523|144346594|SUPERIORITY|Adjusted mean, difference with placebo, 95% confidence interval (CI), and p-value were based on a mixed model for repeated measures (MMRM) model, with change from baseline in MDS-UPDRS score as dependent variable and with fixed effects of treatment group, time, treatment group-by-time interaction, region, PD subtype, prior use of PD medication, baseline MDS-UPDRS score, baseline MDS-UPDRS by time interaction, baseline striatum SBR values and baseline striatum SBR value by time interaction.|Difference|-0.3||||0.8976|TWO_SIDED|95.0|-4.888|4.287|||Mixed Model for Repeated Measures|||Change From Baseline in MDS-UPDRS Total Score at Week 52||4.287|-4.888|0.8976
72418135|NCT03318523|144346594|SUPERIORITY|Adjusted mean, difference with placebo, 95% CI, and p-value were based on an MMRM model, with change from baseline in MDS-UPDRS score as dependent variable and with fixed effects of treatment group, time, treatment group-by-time interaction, region, PD subtype, prior use of PD medication, baseline MDS-UPDRS score, baseline MDS-UPDRS by time interaction, baseline striatum SBR values and baseline striatum SBR value by time interaction.|Difference|0.5||||0.796|TWO_SIDED|95.0|-3.31|4.312|||Mixed Model for Repeated Measures|||Change From Baseline in MDS-UPDRS Total Score at Week 52||4.312|-3.310|0.7960
72418136|NCT03318523|144346594|SUPERIORITY|Adjusted mean, difference with placebo, 95% CI, and p-value were based on an MMRM model, with change from baseline in MDS-UPDRS score as dependent variable and with fixed effects of treatment group, time, treatment group-by-time interaction, region, PD subtype, prior use of PD medication, baseline MDS-UPDRS score, baseline MDS-UPDRS by time interaction, baseline striatum SBR values and baseline striatum SBR value by time interaction.|Difference|0.08||||0.9695|TWO_SIDED|95.0|-3.805|3.956|||Mixed Model for Repeated Measures|||Change From Baseline in MDS-UPDRS Total Score at Week 52||3.956|-3.805|0.9695
72609974|NCT00427934|144748670|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.41||||0.912||90.0|-5.81|6.64||This analysis was carried out using ANCOVA with CRP as the covariate, treatment, region as fixed effects.|ANCOVA|||Week 12||6.64|-5.81|0.912
72609975|NCT00427934|144748671|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.07||||0.653||90.0|-0.31|0.18||This analysis was carried out using ANCOVA with baseline DAS28-4 (CRP) as the covariate, treatment, country as fixed effects.|ANCOVA|||Week 1||0.18|-0.31|0.653
72609976|NCT00427934|144748671|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.08||||0.703||90.0|-0.41|0.26||This analysis was carried out using ANCOVA with baseline DAS28-4 (CRP) as the covariate, treatment, country as fixed effects.|ANCOVA|||Week 2||0.26|-0.41|0.703
72326116|NCT01897532|144175795|NON_INFERIORITY|The non-inferiority margin was chosen as 1.3 (FDA Guidance for Industry - Diabetes Mellitus - Evaluating Cardiovascular Risk in New Antidiabetic Therapies to Treat Type 2 Diabetes).|Hazard Ratio (HR)|1.02||||0.0002|TWO_SIDED|95.0|0.89|1.17||p-value for Hazard ratio (HR) ≥1.3 (1-sided)|Regression, Cox|Based on a Cox regression model with terms for treatment group and region.||Cox proportional hazard regression model was performed to compare the effect of linagliptin versus placebo. Model included randomised treatment and geographical region as factors. Breslow's method was used for dealing with ties. First hypothesis (non-inferiority of the primary endpoint) was to be tested at the one-sided alpha-level of 2.5%. In case of significance the next set of hypotheses (two separate hypothesis tests) were to be tested with a sequentially rejective multiple test procedure.||1.17|0.89|0.0002
72609977|NCT00427934|144748671|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01||||0.968||90.0|-0.37|0.39||This analysis was carried out using ANCOVA with baseline DAS28-4 (CRP) as the covariate, treatment, country as fixed effects.|ANCOVA|||Week 4||0.39|-0.37|0.968
72609978|NCT00427934|144748671|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.31||||0.21||90.0|-0.72|0.1||This analysis was carried out using ANCOVA with baseline DAS28-4 (CRP) as the covariate, treatment, country as fixed effects.|ANCOVA|||Week 8||0.10|-0.72|0.210
72609979|NCT00427934|144748671|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.696||90.0|-0.53|0.33||This analysis was carried out using ANCOVA with baseline DAS28-4 (CRP) as the covariate, treatment, country as fixed effects.|ANCOVA|||Week 12||0.33|-0.53|0.696
72609980|NCT00427934|144748673|SUPERIORITY_OR_OTHER||Percentage Difference|9.09||||0.155||90.0|-6.16|21.83||p-value (one-sided) was based on Barnard exact test if more than 20% of expected cell counts were \< 5 otherwise Pearson chi-square test.|Barnard/Pearson chi-square test||Percentage Difference = maraviroc responders divided by the number of maraviroc participants analyzed minus placebo responders divided by the number of placebo participants analyzed.|||21.83|-6.16|0.155
72609981|NCT00427934|144748679|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.57||||0.698||90.0|-1.87|3.01||This analysis was carried out ANCOVA with baseline SF-36 score as the covariate, treatment, region as fixed effects.|ANCOVA|||Week 4||3.01|-1.87|0.698
72609982|NCT00427934|144748679|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.68||||0.344||90.0|-4.62|1.26||This analysis was carried out ANCOVA with baseline SF-36 score as the covariate, treatment, region as fixed effects.|ANCOVA|||Week 12||1.26|-4.62|0.344
72609983|NCT00427934|144748680|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.7||||0.734||90.0|-2.71|4.11||This analysis was carried out ANCOVA with baseline SF-36 score as the covariate, treatment, region as fixed effects.|ANCOVA|||Week 4||4.11|-2.71|0.734
72609984|NCT00427934|144748680|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.56||||0.818||90.0|-3.5|4.62||This analysis was carried out ANCOVA with baseline SF-36 score as the covariate, treatment, region as fixed effects.|ANCOVA|||Week 12||4.62|-3.50|0.818
72609985|NCT00427934|144748681|SUPERIORITY_OR_OTHER|||||||0.649||95.0|||||Fisher Exact|||||||0.649
72609986|NCT00427934|144748682|SUPERIORITY_OR_OTHER|||||||0.9826||95.0|||||Log Rank|||||||0.9826
72609987|NCT01373164|144748690|SUPERIORITY|The planned primary analysis for this study utilized a Bayesian exponential-likelihood model, incorporating historical overall survival (OS) data from 2 studies (Oettle et al. 2005; Saif et al. 2009). The primary analysis was performed using strong borrowing from the historical data. The model was estimated to borrow approximately 37 events from the historical studies.|Hazard Ratio (HR)|0.794|||||TWO_SIDED|95.0|0.59|1.085|||Bayesian Analysis|Primary comparison was to be considered successful if there was at least 0.85 posterior probability that the hazard ratio (HR) for OS of LY+Gem is \<1.|This is a Credible Interval estimated from the Bayesian analysis.|||1.085|0.590|
72609988|NCT01462942|144748756|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.125|||<|0.0001|TWO_SIDED|95.0|0.09|0.16|||Mixed Models Analysis|Adjusted by pre- and post-bronchodilator, age, and baseline FEV1 as covariates, and treatment group, sex, and smoking-status as fixed effect factors||||0.160|0.090|<0.0001
72609989|NCT01462942|144748756|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.069||||0.0001|TWO_SIDED|95.0|0.034|0.105|||Mixed Models Analysis|Adjusted by pre- and post-bronchodilator, age, and baseline FEV1 as covariates, and treatment group, sex, and smoking-status as fixed effect factors||||0.105|0.034|0.0001
72609990|NCT01462942|144748757|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.085|||<|0.0001|TWO_SIDED|95.0|0.051|0.119|||Mixed Models Analysis|Adjusted by pre- and post-bronchodilator, age, and baseline FEV1 as covariates, and treatment group, sex, and smoking-status as fixed effect factors||||0.119|0.051|<0.0001
72609991|NCT01462942|144748757|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.053||||0.0022|TWO_SIDED|95.0|0.019|0.087|||Mixed Models Analysis|Adjusted by pre- and post-bronchodilator, age, and baseline FEV1 as covariates, and treatment group, sex, and smoking-status as fixed effect factors||||0.087|0.019|0.0022
72609992|NCT01462942|144748758|SUPERIORITY_OR_OTHER||Least squares mean difference|1.293|||<|0.0001|TWO_SIDED|95.0|0.728|1.859|||Mixed Models Analysis|Adjusted by BDI baseline score and age as covariates, with treatment group, gender, smoking-status, visit, and group-by-visit as fixed effect factors||||1.859|0.728|<0.0001
72609993|NCT01462942|144748758|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|1.162|||<|0.0001|TWO_SIDED|95.0|0.593|1.73|||Mixed Models Analysis|||Adjusted by BDI baseline score and age as covariates, with treatment group, gender, smoking-status, visit, and group-by-visit as fixed effect factors||1.730|0.593|<0.0001
72609994|NCT01462942|144748759|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.653||||0.598|TWO_SIDED|95.0|-3.082|1.776|||Mixed Models Analysis|Adjusted by SGRQ baseline score and age as covariates, with treatment group, gender, smoking-status, visit, and group-by-visit as fixed effect factors||||1.776|-3.082|0.5980
72609995|NCT01462942|144748759|SUPERIORITY_OR_OTHER||Least squares mean difference|-1.828||||0.1406|TWO_SIDED|95.0|-4.259|0.604|||Mixed Models Analysis|Adjusted by SGRQ baseline score and age as covariates, with treatment group, gender, smoking-status, visit, and group-by-visit as fixed effect factors||||0.604|-4.259|0.1406
72609996|NCT01027845|144748760|NON_INFERIORITY|Comparability to the 105553 study in terms of non-inferiority was demonstrated if the upper limit (UL) of the two-sided 95% confidence interval(CI) on the GMC ratios (GMCs from 105553 10Pn Group over GMCs from 10Pn Group) were below a limit of 2-fold for all 10 vaccine pneumococcal serotypes. Number of participants analysed =1100 in the 105553 10Pn Group; GMC= 1.05 µg/mL with 95% CI = (1.00 to 1.10).|GMC ratio|0.16|||||TWO_SIDED|95.0|0.14|0.18||||||"Immune response of Synflorix vaccine tested between subjects of the 10Pn Group of the study and healthy European subjects from the 10PN-PD-DIT-001 (105553) study (with following indication: 3-dose primary vaccination of infants between 6 to 12 weeks of age at the time of the first vaccination with Synflorix), that formed the 105553 10Pn Group.~At 1 month after primary immunization (post-dose 3), ELISA GMC ratio (105553 10Pn Group over 10Pn Group) was calculated for pneumococcal serotype 1."||0.18|0.14|
72418137|NCT03318523|144346595|SUPERIORITY|Adjusted mean, difference with delayed start group, 95% CI, and p-value were based on an MMRM model, with change from baseline in MDS-UPDRS score as dependent variable and with fixed effects of treatment group, time, treatment group-by-time interaction, region, PD subtype, prior use of PD medication, corresponding baseline MDS-UPDRS score, corresponding baseline MDS-UPDRS by time interaction, baseline striatum SBR values and baseline striatum SBR value by time interaction.|Difference|-0.28||||0.9093|TWO_SIDED|95.0|-5.035|4.483|||Mixed Model for Repeated Measures|||Change From Baseline in MDS-UPDRS Total Score at Week 72||4.483|-5.035|0.9093
72418138|NCT03318523|144346595|SUPERIORITY|Adjusted mean, difference with delayed start group, 95% CI, and p-value were based on an MMRM model, with change from baseline in MDS-UPDRS score as dependent variable and with fixed effects of treatment group, time, treatment group-by-time interaction, region, PD subtype, prior use of PD medication, corresponding baseline MDS-UPDRS score, corresponding baseline MDS-UPDRS by time interaction, baseline striatum SBR values and baseline striatum SBR value by time interaction.|Difference|1.55||||0.4327|TWO_SIDED|95.0|-2.336|5.44|||Mixed Model for Repeated Measures|||Change From Baseline in MDS-UPDRS Total Score at Week 72||5.440|-2.336|0.4327
72418139|NCT03318523|144346595|SUPERIORITY|Adjusted mean, difference with delayed start group, 95% CI, and p-value were based on an MMRM model, with change from baseline in MDS-UPDRS score as dependent variable and with fixed effects of treatment group, time, treatment group-by-time interaction, region, PD subtype, prior use of PD medication, corresponding baseline MDS-UPDRS score, corresponding baseline MDS-UPDRS by time interaction, baseline striatum SBR values and baseline striatum SBR value by time interaction.|Difference|-0.17||||0.933|TWO_SIDED|95.0|-4.051|3.719|||Mixed Model with repeated Measures|||Change From Baseline in MDS-UPDRS Total Score at Week 72||3.719|-4.051|0.9330
72609997|NCT01027845|144748760|NON_INFERIORITY|Comparability to the 105553 study in terms of non-inferiority was demonstrated if the upper limit (UL) of the two-sided 95% confidence interval(CI) on the GMC ratios (GMCs from 105553 10Pn Group over GMCs from 10Pn Group) were below a limit of 2-fold for all 10 vaccine pneumococcal serotypes. Number of participants analysed =1106 in the 105553 10Pn Group; GMC= 1.45 µg/mL with 95% CI = (1.38 to 1.53).|GMC ratio|0.22|||||TWO_SIDED|95.0|0.2|0.25||||||"Immune response of Synflorix vaccine tested between subjects of the 10Pn Group of the study and healthy European subjects from the 10PN-PD-DIT-001 (105553) study (with following indication: 3-dose primary vaccination of infants between 6 to 12 weeks of age at the time of the first vaccination with Synflorix), that formed the 105553 10Pn Group.~At 1 month after primary immunization (post-dose 3), ELISA GMC ratio (105553 10Pn Group over 10Pn Group) was calculated for pneumococcal serotype 4."||0.25|0.2|
72609998|NCT01027845|144748760|NON_INFERIORITY|Comparability to the 105553 study in terms of non-inferiority was demonstrated if the upper limit (UL) of the two-sided 95% confidence interval(CI) on the GMC ratios (GMCs from 105553 10Pn Group over GMCs from 10Pn Group) were below a limit of 2-fold for all 10 vaccine pneumococcal serotypes. Number of participants analysed =1104 in the 105553 10Pn Group; GMC= 1.70 µg/mL with 95% CI = (1.62 to 1.78).|GMC ratio|0.26|||||TWO_SIDED|95.0|0.23|0.29||||||"Immune response of Synflorix vaccine tested between subjects of the 10Pn Group of the study and healthy European subjects from the 10PN-PD-DIT-001 (105553) study (with following indication: 3-dose primary vaccination of infants between 6 to 12 weeks of age at the time of the first vaccination with Synflorix), that formed the 105553 10Pn Group.~At 1 month after primary immunization (post-dose 3), ELISA GMC ratio (105553 10Pn Group over 10Pn Group) was calculated for pneumococcal serotype 5."||0.29|0.23|
72609999|NCT01027845|144748760|NON_INFERIORITY|Comparability to the 105553 study in terms of non-inferiority was demonstrated if the upper limit (UL) of the two-sided 95% confidence interval(CI) on the GMC ratios (GMCs from 105553 10Pn Group over GMCs from 10Pn Group) were below a limit of 2-fold for all 10 vaccine pneumococcal serotypes. Number of participants analysed =1100 in the 105553 10Pn Group; GMC= 0.33 µg/mL with 95% CI = (0.30 to 0.36).|GMC ratio|0.19|||||TWO_SIDED|95.0|0.16|0.23||||||"Immune response of Synflorix vaccine tested between subjects of the 10Pn Group of the study and healthy European subjects from the 10PN-PD-DIT-001 (105553) study (with following indication: 3-dose primary vaccination of infants between 6 to 12 weeks of age at the time of the first vaccination with Synflorix), that formed the 105553 10Pn Group.~At 1 month after primary immunization (post-dose 3), ELISA GMC ratio (105553 10Pn Group over 10Pn Group) was calculated for pneumococcal serotype 6B."||0.23|0.16|
72610000|NCT01027845|144748760|NON_INFERIORITY|Comparability to the 105553 study in terms of non-inferiority was demonstrated if the upper limit (UL) of the two-sided 95% confidence interval(CI) on the GMC ratios (GMCs from 105553 10Pn Group over GMCs from 10Pn Group) were below a limit of 2-fold for all 10 vaccine pneumococcal serotypes. Number of participants analysed =1107 in the 105553 10Pn Group; GMC= 1.72 µg/mL with 95% CI = (1.64 to 1.80).|GMC ratio|0.28|||||TWO_SIDED|95.0|0.25|0.31||||||"Immune response of Synflorix vaccine tested between subjects of the 10Pn Group of the study and healthy European subjects from the 10PN-PD-DIT-001 (105553) study (with following indication: 3-dose primary vaccination of infants between 6 to 12 weeks of age at the time of the first vaccination with Synflorix), that formed the 105553 10Pn Group.~At 1 month after primary immunization (post-dose 3), ELISA GMC ratio (105553 10Pn Group over 10Pn Group) was calculated for pneumococcal serotype 7F."||0.31|0.25|
72610001|NCT01027845|144748760|NON_INFERIORITY|Comparability to the 105553 study in terms of non-inferiority was demonstrated if the upper limit (UL) of the two-sided 95% confidence interval(CI) on the GMC ratios (GMCs from 105553 10Pn Group over GMCs from 10Pn Group) were below a limit of 2-fold for all 10 vaccine pneumococcal serotypes. Number of participants analysed =1103 in the 105553 10Pn Group; GMC= 1.32 µg/mL with 95% CI = (1.25 to 1.38).|GMC ratio|0.24|||||TWO_SIDED|95.0|0.22|0.27||||||"Immune response of Synflorix vaccine tested between subjects of the 10Pn Group of the study and healthy European subjects from the 10PN-PD-DIT-001 (105553) study (with following indication: 3-dose primary vaccination of infants between 6 to 12 weeks of age at the time of the first vaccination with Synflorix), that formed the 105553 10Pn Group.~At 1 month after primary immunization (post-dose 3), ELISA GMC ratio (105553 10Pn Group over 10Pn Group) was calculated for pneumococcal serotype 9V."||0.27|0.22|
72418140|NCT03318523|144346597|SUPERIORITY|Adjusted mean, difference with delayed start group, 95% CI, and p-value were based on an MMRM model, with change from baseline in MDS-UPDRS score as dependent variable and with fixed effects of treatment group, time, treatment group-by-time interaction, region, PD subtype, prior use of PD medication, corresponding baseline MDS-UPDRS score, corresponding baseline MDS-UPDRS by time interaction, baseline striatum SBR values and baseline striatum SBR value by time interaction.|Difference|0.41||||0.8828|TWO_SIDED|95.0|-5.013|5.825|||Mixed Model for Repeated Measures|||||5.825|-5.013|0.8828
72610002|NCT01027845|144748760|NON_INFERIORITY|Comparability to the 105553 study in terms of non-inferiority was demonstrated if the upper limit (UL) of the two-sided 95% confidence interval(CI) on the GMC ratios (GMCs from 105553 10Pn Group over GMCs from 10Pn Group) were below a limit of 2-fold for all 10 vaccine pneumococcal serotypes. Number of participants analysed =1100 in the 105553 10Pn Group; GMC= 2.90 µg/mL with 95% CI = (2.75 to 3.05).|GMC ratio|0.29|||||TWO_SIDED|95.0|0.25|0.33||||||"Immune response of Synflorix vaccine tested between subjects of the 10Pn Group of the study and healthy European subjects from the 10PN-PD-DIT-001 (105553) study (with following indication: 3-dose primary vaccination of infants between 6 to 12 weeks of age at the time of the first vaccination with Synflorix), that formed the 105553 10Pn Group.~At 1 month after primary immunization (post-dose 3), ELISA GMC ratio (105553 10Pn Group over 10Pn Group) was calculated for pneumococcal serotype 14."||0.33|0.25|
72610003|NCT01027845|144748760|NON_INFERIORITY|Comparability to the 105553 study in terms of non-inferiority was demonstrated if the upper limit (UL) of the two-sided 95% confidence interval(CI) on the GMC ratios (GMCs from 105553 10Pn Group over GMCs from 10Pn Group) were below a limit of 2-fold for all 10 vaccine pneumococcal serotypes. Number of participants analysed =1102 in the 105553 10Pn Group; GMC= 1.66 µg/mL with 95% CI = (1.56 to 1.77).|GMC ratio|0.1|||||TWO_SIDED|95.0|0.09|0.12||||||"Immune response of Synflorix vaccine tested between subjects of the 10Pn Group of the study and healthy European subjects from the 10PN-PD-DIT-001 (105553) study (with following indication: 3-dose primary vaccination of infants between 6 to 12 weeks of age at the time of the first vaccination with Synflorix), that formed the 105553 10Pn Group.~At 1 month after primary immunization (post-dose 3), ELISA GMC ratio (105553 10Pn Group over 10Pn Group) was calculated for pneumococcal serotype 18C."||0.12|0.09|
72610004|NCT01027845|144748760|NON_INFERIORITY|Comparability to the 105553 study in terms of non-inferiority was demonstrated if the upper limit (UL) of the two-sided 95% confidence interval(CI) on the GMC ratios (GMCs from 105553 10Pn Group over GMCs from 10Pn Group) were below a limit of 2-fold for all 10 vaccine pneumococcal serotypes. Number of participants analysed =1104 in the 105553 10Pn Group; GMC= 1.84 µg/mL with 95% CI = (1.71 to 1.98).|GMC ratio|0.11|||||TWO_SIDED|95.0|0.09|0.12||||||"Immune response of Synflorix vaccine tested between subjects of the 10Pn Group of the study and healthy European subjects from the 10PN-PD-DIT-001 (105553) study (with following indication: 3-dose primary vaccination of infants between 6 to 12 weeks of age at the time of the first vaccination with Synflorix), that formed the 105553 10Pn Group.~At 1 month after primary immunization (post-dose 3), ELISA GMC ratio (105553 10Pn Group over 10Pn Group) was calculated for pneumococcal serotype 19F."||0.12|0.09|
72610005|NCT01027845|144748760|NON_INFERIORITY|Comparability to the 105553 study in terms of non-inferiority was demonstrated if the upper limit (UL) of the two-sided 95% confidence interval(CI) on the GMC ratios (GMCs from 105553 10Pn Group over GMCs from 10Pn Group) were below a limit of 2-fold for all 10 vaccine pneumococcal serotypes. Number of participants analysed =1102 in the 105553 10Pn Group; GMC= 0.53 µg/mL with 95% CI = (0.50 to 0.57).|GMC ratio|0.25|||||TWO_SIDED|95.0|0.21|0.29||||||"Immune response of Synflorix vaccine tested between subjects of the 10Pn Group of the study and healthy European subjects from the 10PN-PD-DIT-001 (105553) study (with following indication: 3-dose primary vaccination of infants between 6 to 12 weeks of age at the time of the first vaccination with Synflorix), that formed the 105553 10Pn Group.~At 1 month after primary immunization (post-dose 3), ELISA GMC ratio (105553 10Pn Group over 10Pn Group) was calculated for pneumococcal serotype 23F."||0.29|0.21|
72610006|NCT03154086|144748847|OTHER||Ratio|0.8||||0.204|TWO_SIDED|90.0|0.594|1.077|||ANOVA|||||1.077|0.5940|0.204
72610007|NCT03154086|144748848|OTHER||Ratio|0.7325||||0.118|TWO_SIDED|90.0|0.5267|1.019|||ANOVA|||||1.019|0.5267|0.118
72610008|NCT03154086|144748849|OTHER||Ratio|0.6502||||0.157|TWO_SIDED|90.0|0.3876|1.091|||ANOVA|||||1.091|0.3876|0.157
72610009|NCT04465422|144748856|SUPERIORITY||Mean Difference (Final Values)|3.2|STANDARD_ERROR_OF_MEAN|0.97|<|0.001|TWO_SIDED|95.0|1.65|5.55|||Mixed Models Analysis|||Statistical Anaiysis 1 is according to Occupational Performance History Interview - II (OPHI-II) total score.||5.55|1.65|<0.001
72610010|NCT04465422|144748856|SUPERIORITY||Mean Difference (Final Values)|0.8|STANDARD_ERROR_OF_MEAN|0.53||0.019|TWO_SIDED|95.0|0.23|2.37|||Mixed Models Analysis|||Statistical Analysis 2 is based on Occupational Identity(range 11\~44；higher scores indicates better performance), a sub-domain of OPHI-II. The Occupational Identity scale is designed to measure the degree to which a client has internalized a positive occupational identity (i.e., has values, interests, and confidence; sees self in various occupational roles; has an image of the kind of life desired)||2.37|0.23|0.019
72610011|NCT04465422|144748856|SUPERIORITY||Mean Difference (Final Values)|1.4|STANDARD_ERROR_OF_MEAN|0.43||0.006|TWO_SIDED|95.0|0.38|2.11|||Mixed Models Analysis|||Statistical Analysis 3 is based on Occupational Competence(range 9\~36；higher scores indicate better performance), a sub-domain of OPHI-II. The Occupational Competence scale is designed to measure the degree to which a client is able to sustain a pattern of occupational behavior that is productive and satisfying.||2.11|0.38|0.006
72610012|NCT04465422|144748856|SUPERIORITY||Mean Difference (Final Values)|0.9|STANDARD_ERROR_OF_MEAN|0.38||0.136|TWO_SIDED|95.0|-0.19|1.35|||Mixed Models Analysis|||Statistical Analysis 4 is based on Occupational Behavior Settings(range 9\~36；higher scores indicate greater performance), a sub-domain of OPHI-II. The Occupational Behavior Settings scale addresses the impact of the environment on the person's occupational life.||1.35|-0.19|0.136
72326117|NCT01897532|144175795|OTHER||Hazard Ratio (HR)|1.02||||0.6301|TWO_SIDED|95.0|0.89|1.17||p-value for HR ≥1.0 (1-sided).|Regression, Cox|Based on a Cox regression model with terms for treatment group and region.||Cox proportional hazard regression model was performed to compare the effect of linagliptin versus placebo. Model included randomised treatment and geographical region as factors. Breslow's method was used for dealing with ties. First hypothesis (non-inferiority of the primary endpoint) was to be tested at the one-sided alpha-level of 2.5%. In case of significance the next set of hypotheses (two separate hypothesis tests) were to be tested with a sequentially rejective multiple test procedure.||1.17|0.89|0.6301
72610013|NCT04465422|144748857|SUPERIORITY||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|1.53||0.592|TWO_SIDED|95.0|-3.9|2.25|||Mixed Models Analysis|||Statistical Analysis 1 is based on Lawton Instrumental Activities Daily Living (range 0\~23；the higher scores indicate greater performance) total scores.||2.25|-3.90|0.592
72610014|NCT04465422|144748857|SUPERIORITY||Mean Difference (Final Values)|4.1|STANDARD_ERROR_OF_MEAN|2.37||0.302|TWO_SIDED|95.0|-2.29|7.23|||Mixed Models Analysis|||Statistical Analysis 2 is based on Comprehensive Occupational Therapy Evaluation Scale (range 20\~100；the higher scores indicate greater performance) total scores.||7.23|-2.29|0.302
72610015|NCT04465422|144748857|SUPERIORITY||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|3.25||0.931|TWO_SIDED|95.0|-6.25|6.82|||Mixed Models Analysis|||Statistical Analysis 3 is based on Personal and Social Performance scale (range 1\~100；the higher scores indicate greater performance) total scores.||6.82|-6.25|0.931
72610016|NCT04465422|144748857|SUPERIORITY||Mean Difference (Final Values)|-1.4|STANDARD_ERROR_OF_MEAN|0.85||0.981|TWO_SIDED|95.0|-1.73|1.69|||Mixed Models Analysis|||Statistical Analysis 4 is based on Canadian Occupational Performance Measure (range 1\~10；the higher scores indicate greater performance) total scores.||1.69|-1.73|0.981
72610017|NCT00572832|144748896|NON_INFERIORITY_OR_EQUIVALENCE|The formula used for calculating sample size for the treatment arm (NT) is NT = (1 + 1/u) (Zα + Zβ)2 σ2 /\[log (RGMC) -δ0\] where u is the ratio of the size of the control and treatment arms, one sided alpha that is divided by 4, a non-inferiority margin (δ0 of natural log 0.5), the expected ratio of geometric mean concentrations RGMC set at 0.8, and a standard deviation of 1.26 (the largest for HPV-16). The calculated sample size for a power of 80% was 75 participants in each arm.||||||0.025||95.0||||Non-inferiority was tested against a one-sided null hypothesis (alpha=.025) that the post Dose 3 GMT ratio of the Alternate to Standard schedule was ≤ 0.5 for each HPV type. Results: GMT ratios were 2.23, 3,17, 2.14, and 1.68 for types 6,11,16,\& 18.|ANOVA|Log transformed the data and calculated GMTs. Tested if post Dose 3 GMT ratio of the Alternate to Standard schedule was ≤ 0.5 for each HPV type||Non-inferiority tested against 1-sided null hypothesis (alpha=.025) that the post Dose 3 GMT ratio of the Alternate to Standard schedule was ≤ 0.5 for each HPV type||||.025
72610018|NCT01704261|144748897|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.61|||<|0.001|TWO_SIDED|95.0|-0.85|-0.38|||Difference in the least squares means|Based on a constrained longitudinal data analysis (cLDA) method with a restriction of the same baseline mean across treatment groups.||||-0.38|-0.85|<0.001
72610019|NCT01704261|144748898|SUPERIORITY_OR_OTHER||Difference in % Omarigliptin vs Placebo|9.8|||||TWO_SIDED|95.0|-1.4|20.8||||||||20.8|-1.4|
72610020|NCT01704261|144748899|SUPERIORITY_OR_OTHER||Difference in % Omarigliptin vs Placebo|0.0|||||TWO_SIDED|95.0|-4.3|4.3||||||||4.3|-4.3|
72610021|NCT01704261|144748900|SUPERIORITY_OR_OTHER||Difference of the least squares means|-16.6|||<|0.001|TWO_SIDED|95.0|-25.5|-7.8|||Difference in the least squares means|Based on a constrained longitudinal data analysis (cLDA) method with a restriction of the same baseline mean across treatment groups.||||-7.8|-25.5|<0.001
72610022|NCT01704261|144748901|SUPERIORITY_OR_OTHER||Between-group Rate Difference|19.3|||<|0.001|TWO_SIDED|95.0|11.7|27.6|||Miettinen & Nurminen method|Between-group confidence intervals and p-value (%) A1C \<7.0%; estimated using standard multiple imputation techniques.||||27.6|11.7|<0.001
72610023|NCT01704261|144748901|SUPERIORITY_OR_OTHER||Between-group Rate Difference (%)|8.0||||0.005|TWO_SIDED|95.0|2.7|14.5|||Miettinen & Nurminen method|Between-group confidence intervals and p-value (%) A1C \<7.0%; estimated using standard multiple imputation techniques.||||14.5|2.7|0.005
72610024|NCT00062166|144748923|NON_INFERIORITY|Time dependent risk for requiring an intervention for pancreatic neuroendocrine tumors (PNET), among 63 patients with PNETs with diameter \>1.2 and \<3 cm, and a known position of germline VHL pathogenic variant (n=63). Comparison between exon 3 vs exon 1 and 2.|Hazard Ratio (HR)|3.3||||0.02|TWO_SIDED|95.0|1.2|9.1|||Regression, Cox|||||9.1|1.2|0.02
72610025|NCT00833755|144748927|SUPERIORITY_OR_OTHER_LEGACY|||||||0.274|||||||Kruskal-Wallis|||||||0.274
72610026|NCT00833755|144748928|SUPERIORITY_OR_OTHER_LEGACY|||||||0.552|||||||Kruskal-Wallis|||||||0.552
72610027|NCT00833755|144748929|SUPERIORITY_OR_OTHER_LEGACY|||||||0.004|||||||Kruskal-Wallis|||||||0.004
72610028|NCT02439164|144748930|SUPERIORITY||Mean Difference (Net)|23.51|||<|0.01|TWO_SIDED|95.0|14.16|32.87|||t-test, 2 sided|bonferroni correction was used for post hoc analysis, P value less than 0.05 indicated statistical significance.|this described the difference during midazolam sedation between the glioma and control group without dividing into subgroups.||Oneway Analysis of Variance (ANOVA) was used to test the difference among hands in a certain time point. General linear model for repeated measures ANOVA was used to analyze the time difference of test before and after drug administration,|32.87|14.16|<0.01
72610029|NCT02343224|144748936|OTHER||Kaplan-Meier estimate|76.2|||||TWO_SIDED|95.0|52.1|100.0||||||This Kaplan-Meier estimate is the conditional probability of event-free survival among study participants at 12 and 24 months.||100|52.1|
72610030|NCT02343224|144748937|OTHER||Kaplan-Meier estimate|75.0|||||TWO_SIDED|95.0|50.3|100.0||||||This Kaplan-Meier estimate is the conditional probability of overall survival among participants at 12 and 24 months.||100|50.3|
72610031|NCT02475369|144748956|SUPERIORITY|||||||0.271|||||||Wilcoxon (Mann-Whitney)|||||||0.271
72610032|NCT02475369|144748957|OTHER|In order to calculate a correlation between baseline fecal elastase-1 and total CeD-GSRS score on PES treatment vs. placebo treatment, we calculated a Spearman's rank correlation coefficient between the two independent variables.||||||0.995|||||||Spearman rank coefficient|||||||0.995
72610033|NCT02475369|144748958|OTHER|In order to evaluate the estimated difference of the effect of Pancreatic Enzyme Supplement versus Placebo for the Celiac Symptom Index (CSI) scores, we used a linear mixed effects model with the nlme package.||||||0.08|||||||Linear Mixed Effects model|||||||0.08
72610034|NCT02139540|144748982|SUPERIORITY||||||<|0.05|||||||Mixed Models Analysis|||The primary outcome (HDRS-21) was analyzed with a repeated-measures mixed effects linear model using restricted maximum likelihood estimation. To adjust for the observed carryover effect, the model included a randomization group term and a three-way interaction (treatment × time × randomization group)||||<0.05
72610035|NCT02139540|144748983|SUPERIORITY||||||<|0.05|||||||Mixed Models Analysis|||||||<0.05
72610036|NCT02717195|144749020|SUPERIORITY||Mean Difference (Final Values)|-0.12||||0.9196|TWO_SIDED|95.0|-2.37|2.13||Multiplicity adjustment was planned for the testing of the primary enpoint, but was not applied since all p-values\>0.05.|Mixed model repeated measures|||The mean changes from Randomization in PANSS total score was analysed using a MMRM approach. The model included the fixed, categorical effects of treatment, country, week, treatment-by-week interaction, PC Period treatment, PC Period treatment-by-week interaction, and the continuous covariates of Randomization score and Randomization score-by-week interaction with an unstructured covariance structure to model the within-patient errors.||2.13|-2.37|0.9196
72610037|NCT02717195|144749020|SUPERIORITY||Mean Difference (Final Values)|1.67||||0.1474|TWO_SIDED|95.0|-0.59|3.94||Multiplicity adjustment was planned for the testing of the primary endpoint, but was not applied since all p-values\>0.05.|Mixed model repeated measures|||The mean changes from Randomization in PANSS total score was analysed using a MMRM approach. The model included the fixed, categorical effects of treatment, country, week, treatment-by-week interaction, PC Period treatment, PC Period treatment-by-week interaction, and the continuous covariates of Randomization score and Randomization score-by-week interaction with an unstructured covariance structure to model the within-patient errors.||3.94|-0.59|0.1474
72610038|NCT02717195|144749021|SUPERIORITY||Mean Difference (Final Values)|0.96||||0.2998|TWO_SIDED|95.0|-0.86|2.78||Multiplicity adjustment was planned for the testing of the primary endpoint, but was not applied since all p-values\>0.05.|Mixed model repeated measures|||The mean changes from Randomization in PSP score was analysed using a MMRM approach. The model included the fixed, categorical effects of treatment, country, week, treatment-by-week interaction, PC Period treatment, PC Period treatment-by-week interaction, and the continuous covariates of Randomization score and Randomization score-by-week interaction with an unstructured covariance structure to model the within-patient errors.||2.78|-0.86|0.2998
72610039|NCT02717195|144749021|SUPERIORITY||Mean Difference (Final Values)|-0.71||||0.4478|TWO_SIDED|95.0|-2.54|1.12||Multiplicity adjustment was planned for the testing of the primary endpoint, but was not applied since all p-values\>0.05.|Mixed model repeated measures|||The mean changes in PSP score was analysed using a MMRM approach. The model included the fixed, categorical effects of treatment, country, week, treatment-by-week interaction, PC Period treatment, PC Period treatment-by-week interaction, and the continuous covariates of Randomization score and Randomization score-by-week interaction with an unstructured covariance structure to model the within-patient errors.||1.12|-2.54|0.4478
72610040|NCT01420536|144749049|SUPERIORITY_OR_OTHER_LEGACY|||||||0.569|TWO_SIDED|95.0||||P values less than 0.05 would be considered statistically significant in this study.|Wilcoxon (Mann-Whitney)|||Statistical analysis was performed by a researcher who was unaware of all procedures performed. The questionnaire about denture satisfaction originated a general score that was compared using the Wilcoxon test, according to the two tested conditions.||||0.569
72610041|NCT01420536|144749050|SUPERIORITY_OR_OTHER_LEGACY|||||||0.339|TWO_SIDED|95.0||||P values less than 0.05 would be considered statistically significant in this study.|t-test, 2 sided|Paired t-test.||For the kinesiographic assessment, the Kolmogorov-Smirnov test was used to evaluate whether the variables had normal distribution, which was positive in the majority of cases. A comparison between the values obtained for both groups was performed by means of the paired sample t-test.||||0.339
72610042|NCT01420536|144749051|SUPERIORITY|||||||0.515||||||P values less than 0.05 would be considered statistically significant in this study.|t-test, 2 sided|Paired t-test.||For the kinesiographic assessment, the Kolmogorov-Smirnov test was used to evaluate whether the variables had normal distribution, which was positive in the majority of cases. A comparison between the values obtained for both groups was performed by means of the paired sample t-test.||||0.515
72610043|NCT01420536|144749052|SUPERIORITY_OR_OTHER_LEGACY|||||||0.485||||||P values less than 0.05 would be considered statistically significant in this study.|t-test, 2 sided|Paired t test.||For the kinesiographic assessment, the Kolmogorov-Smirnov test was used to evaluate whether the variables had normal distribution, which was positive in the majority of cases. A comparison between the values obtained for both groups was performed by means of the paired sample t-test.||||0.485
72610044|NCT01420536|144749053|SUPERIORITY_OR_OTHER_LEGACY|||||||0.111||||||P values less than 0.05 would be considered statistically significant in this study.|t-test, 2 sided|Paired t-test.||For the kinesiographic assessment, the Kolmogorov-Smirnov test was used to evaluate whether the variables had normal distribution, which was positive in the majority of cases. A comparison between the values obtained for both groups was performed by means of the paired sample t-test.||||0.111
72610045|NCT01420536|144749054|SUPERIORITY_OR_OTHER_LEGACY|||||||0.399||||||P values less than 0.05 would be considered statistically significant in this study.|t-test, 2 sided|Paired t-test.||For the kinesiographic assessment, the Kolmogorov-Smirnov test was used to evaluate whether the variables had normal distribution, which was positive in the majority of cases. A comparison between the values obtained for both groups was performed by means of the paired sample t-test.||||0.399
72418141|NCT03318523|144346597|SUPERIORITY|Adjusted mean, difference with delayed start group, 95% CI, and p-value were based on an MMRM model, with change from baseline in MDS-UPDRS score as dependent variable and with fixed effects of treatment group, time, treatment group-by-time interaction, region, PD subtype, prior use of PD medication, corresponding baseline MDS-UPDRS score, corresponding baseline MDS-UPDRS by time interaction, baseline striatum SBR values and baseline striatum SBR value by time interaction.|Difference|0.84||||0.7019|TWO_SIDED|95.0|-3.458|5.128|||Mixed Model for Repeated Measure|||||5.128|-3.458|0.7019
72418142|NCT03318523|144346597|SUPERIORITY|Adjusted mean, difference with delayed start group, 95% CI, and p-value were based on an MMRM model, with change from baseline in MDS-UPDRS score as dependent variable and with fixed effects of treatment group, time, treatment group-by-time interaction, region, PD subtype, prior use of PD medication, corresponding baseline MDS-UPDRS score, corresponding baseline MDS-UPDRS by time interaction, baseline striatum SBR values and baseline striatum SBR value by time interaction.|Difference|0.99||||0.6519|TWO_SIDED|95.0|-3.323|5.301|||Mixed Model for Repeated Measures|||||5.301|-3.323|0.6519
72418143|NCT03318523|144346599|SUPERIORITY|Adjusted mean, difference with placebo, 95% CI, and p-value were based on an MMRM model, with change from baseline in MDS-UPDRS score as dependent variable and with fixed effects of treatment group, time, treatment group-by-time interaction, region, PD subtype, prior use of PD medication, baseline MDS-UPDRS score, baseline MDS-UPDRS by time interaction, baseline striatum SBR values and baseline striatum SBR value by time interaction.|Difference|-0.53||||0.4327|TWO_SIDED|95.0|-1.851|0.794|||Mixed Model for Repeated Measures|||Change from Baseline in MDS-UPDRS Subpart I Score at Week 52||0.794|-1.851|0.4327
72610046|NCT01420536|144749055|SUPERIORITY_OR_OTHER_LEGACY|||||||0.55||||||P values less than 0.05 would be considered statistically significant in this study.|t-test, 2 sided|Paired t-test.||For the kinesiographic assessment, the Kolmogorov-Smirnov test was used to evaluate whether the variables had normal distribution, which was positive in the majority of cases. A comparison between the values obtained for both groups was performed by means of the paired sample t-test.||||0.550
72610047|NCT01420536|144749056|SUPERIORITY_OR_OTHER_LEGACY|||||||0.609||||||P values less than 0.05 would be considered statistically significant in this study.|t-test, 2 sided|Paired t-test.||For the kinesiographic assessment, the Kolmogorov-Smirnov test was used to evaluate whether the variables had normal distribution, which was positive in the majority of cases. A comparison between the values obtained for both groups was performed by means of the paired sample t-test.||||0.609
72610048|NCT01420536|144749057|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6||||||P values less than 0.05 would be considered statistically significant in this study.|t-test, 2 sided|Paired t-test.||For the kinesiographic assessment, the Kolmogorov-Smirnov test was used to evaluate whether the variables had normal distribution, which was positive in the majority of cases. A comparison between the values obtained for both groups was performed by means of the paired sample t-test.||||0.600
72610049|NCT01420536|144749058|SUPERIORITY_OR_OTHER_LEGACY|||||||0.611||||||P values less than 0.05 would be considered statistically significant in this study.|t-test, 2 sided|Paired t-test.||For the kinesiographic assessment, the Kolmogorov-Smirnov test was used to evaluate whether the variables had normal distribution, which was positive in the majority of cases. A comparison between the values obtained for both groups was performed by means of the paired sample t-test.||||0.611
72610050|NCT01420536|144749059|SUPERIORITY_OR_OTHER_LEGACY|||||||0.044||||||P values less than 0.05 would be considered statistically significant in this study.|t-test, 2 sided|Paired t-test.||For the kinesiographic assessment, the Kolmogorov-Smirnov test was used to evaluate whether the variables had normal distribution, which was positive in the majority of cases. A comparison between the values obtained for both groups was performed by means of the paired sample t-test.||||0.044
72610051|NCT01420536|144749060|SUPERIORITY_OR_OTHER_LEGACY|||||||0.677||||||P values less than 0.05 would be considered statistically significant in this study.|t-test, 2 sided|Paired t-test.||For the kinesiographic assessment, the Kolmogorov-Smirnov test was used to evaluate whether the variables had normal distribution, which was positive in the majority of cases. A comparison between the values obtained for both groups was performed by means of the paired sample t-test.||||0.677
72610052|NCT01420536|144749061|SUPERIORITY_OR_OTHER_LEGACY|||||||0.885||||||P values less than 0.05 would be considered statistically significant in this study.|t-test, 2 sided|Paired t-test.||For the kinesiographic assessment, the Kolmogorov-Smirnov test was used to evaluate whether the variables had normal distribution, which was positive in the majority of cases. A comparison between the values obtained for both groups was performed by means of the paired sample t-test.||||0.885
72610053|NCT02941640|144749065|OTHER|Anova|||||<|0.0001||||||Significant when P\<0.05|ANOVA|||||||<0.0001
72610054|NCT02941640|144749065|OTHER|||||||0.001||||||Significant when P\<0.05.|Tukey post hoc test|||Post hoc analysis was done by Tukey test.||||0.001
72610055|NCT02941640|144749065|OTHER|Tukey post hoc test|||||<|0.0001||||||Significant when P\<0.05|Tukey post hoc test|||||||<0.0001
72610056|NCT02941640|144749065|OTHER|||||||0.044||||||Significant when P\<0.05|Tukey post hoc test|||||||0.044
72610057|NCT02941640|144749065|OTHER||||||<|0.272||||||Significant when P\<0.05.|Tukey post hoc test|||||||<0.272
72610058|NCT02941640|144749065|OTHER|||||||0.835||||||Significant when P\<0.05.|Tukey post hoc test|||||||0.835
72610059|NCT02941640|144749065|OTHER|||||||0.199||||||Significant when P\<0.05.|Tukey post hoc test|||||||0.199
72610060|NCT02941640|144749066|OTHER|Anova|||||<|0.0001||||||Significant when P\<0.05.|ANOVA|||||||<0.0001
72610061|NCT02941640|144749066|OTHER||||||<|0.0001||||||Significant when P\<0.05|Tukey post hoc test|||||||<0.0001
72610062|NCT02941640|144749066|OTHER||||||<|0.0001||||||Significant when P\<0.05|Tukey post hoc test|||||||<0.0001
72610063|NCT02941640|144749066|OTHER||||||<|0.0001||||||Significant when P\<0.05.|Tukey post hoc test|||||||<0.0001
72610064|NCT02941640|144749066|OTHER||||||<|0.0001|||||||Tukey post hoc test|||||||<0.0001
72610065|NCT02941640|144749066|OTHER||||||<|0.0001||||||Significant when P\<0.05.|Tukey post hoc test|||||||<0.0001
72610066|NCT02941640|144749066|OTHER|||||||1||||||Significant when P\<0.05|Tukey post hoc test|||||||1.00
72610067|NCT01265498|144749068|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.9||||0.0002|TWO_SIDED|95.0|1.3|2.8|||Cochran-Mantel-Haenszel|p values and relative benefit were calculated with the Cochran-Mantel-Haenszel chi-square test, stratified by clinic and diabetes status.|obeticholic acid vs placebo|||2.8|1.3|0.0002
72610068|NCT01265498|144749069|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.5||||0.08|TWO_SIDED|95.0|0.9|2.6|||Cochran-Mantel-Haenszel|p values and relative benefit were calculated with the Cochran-Mantel-Haenszel chi-square test, stratified by clinic and diabetes status|obeticholic acid vs placebo|||2.6|0.9|0.08
72610069|NCT01265498|144749070|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.8||||0.004|TWO_SIDED|95.0|1.1|2.7|||Cochran-Mantel-Haenszel|p values and relative benefit were calculated with the Cochran-Mantel-Haenszel chi-square test, stratified by clinic and diabetes status|obeticholic acid vs placebo|||2.7|1.1|0.004
72610070|NCT01265498|144749071|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.3||||0.01|TWO_SIDED|95.0|-0.6|-0.1|||ANCOVA|calculated using ANCOVA, regressing change from baseline to 72 weeks on treatment group and baseline value of the outcome|obeticholic acid vs placebo|||-0.1|-0.6|0.01
72610071|NCT01265498|144749072|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.9|||<|0.0001|TWO_SIDED|95.0|-1.3|-0.5|||ANCOVA|calculated using ANCOVA, regressing change from baseline to 72 weeks on treatment group and baseline value of the outcome|obeticholic acid vs placebo|||-0.5|-1.3|<0.0001
72610072|NCT01265498|144749073|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.5||||0.03|TWO_SIDED|95.0|1.0|2.1|||Cochran-Mantel-Haenszel|p values and relative benefit were calculated with the Cochran-Mantel-Haenszel chi-square test, stratified by clinic and diabetes status|obeticholic acid vs placebo|||2.1|1.0|0.03
72610073|NCT01265498|144749074|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.2||||0.03|TWO_SIDED|95.0|-0.5|0.0|||ANCOVA|calculated using ANCOVA, regressing change from baseline to 72 weeks on treatment group and baseline value of the outcome|obeticholic acid vs placebo|||0.0|-0.5|0.03
72610074|NCT01265498|144749075|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.7||||0.001|TWO_SIDED|95.0|1.2|2.3|||Cochran-Mantel-Haenszel|p values and relative benefit were calculated with the Cochran-Mantel-Haenszel chi-square test, stratified by clinic and diabetes status|obeticholic acid vs. placebo|||2.3|1.2|0.001
72610075|NCT01265498|144749076|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.4||||0.0004|TWO_SIDED|95.0|-0.6|-0.2|||ANCOVA|calculated using ANCOVA, regressing change from baseline to 72 weeks on treatment group and baseline value of the outcome|obeticholic acid vs placebo|||-0.2|-0.6|0.0004
72610076|NCT01265498|144749077|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.6||||0.006|TWO_SIDED|95.0|1.1|2.2|||Cochran-Mantel-Haenszel|p values and relative benefit were calculated with the Cochran-Mantel-Haenszel chi-square test, stratified by clinic and diabetes status|obeticholic acid vs. placebo|||2.2|1.1|0.006
72610077|NCT01265498|144749078|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.3||||0.0006|TWO_SIDED|95.0|-0.5|-0.1|||ANCOVA|calculated using ANCOVA, regressing change from baseline to 72 weeks on treatment group and baseline value of the outcome|obeticholic acid vs placebo|||-0.1|-0.5|0.0006
72610078|NCT01265498|144749079|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.0||||0.9|TWO_SIDED|95.0|0.6|1.7|||Cochran-Mantel-Haenszel|p values and relative benefit were calculated with the Cochran-Mantel-Haenszel chi-square test, stratified by clinic and diabetes status|obeticholic acid vs. placebo|||1.7|0.6|0.90
72610079|NCT01265498|144749080|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0||||0.59|TWO_SIDED|95.0|-0.1|0.2|||ANCOVA|calculated using ANCOVA, regressing change from baseline to 72 weeks on treatment group and baseline value of the outcome|obeticholic acid vs placebo|||0.2|-0.1|0.59
72610080|NCT01265498|144749081|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-20.0|||<|0.0001|TWO_SIDED|95.0|-28.0|-11.0|||ANCOVA|calculated using ANCOVA models, regressing change from baseline to 72 weeks on treatment group and baseline value of the outcome|obeticholic acid vs placebo|||-11|-28|<0.0001
72610081|NCT01265498|144749082|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-12.0||||0.0001|TWO_SIDED|95.0|-18.0|-6.0|||ANCOVA|calculated using ANCOVA models, regressing change from baseline to 72 weeks on treatment group and baseline value of the outcome|obeticholic acid vs placebo|||-6|-18|0.0001
72610082|NCT01265498|144749083|SUPERIORITY_OR_OTHER||Mean Difference (Net)|18.0|||<|0.0001|TWO_SIDED|95.0|13.0|24.0|||ANCOVA|calculated using ANCOVA models, regressing change from baseline to 72 weeks on treatment group and baseline value of the outcome|obeticholic acid vs placebo|||24|13|<0.0001
72610083|NCT01265498|144749084|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-24.0|||<|0.0001|TWO_SIDED|95.0|-35.0|-14.0|||ANCOVA|calculated using ANCOVA models, regressing change from baseline to 72 weeks on treatment group and baseline value of the outcome|obeticholic acid vs placebo|||-14|-35|<0.0001
72610084|NCT01265498|144749085|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.5||||0.002|TWO_SIDED|95.0|-2.4|-0.5|||ANCOVA|calculated using ANCOVA models, regressing change from baseline to 72 weeks on treatment group and baseline value of the outcome|obeticholic acid vs placebo|||-0.5|-2.4|0.002
72610085|NCT01265498|144749086|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.38||||0.0009|TWO_SIDED|95.0|0.16|0.6|||ANCOVA|calculated using ANCOVA models, regressing change from baseline to 72 weeks on treatment group and baseline value of the outcome|obeticholic acid vs placebo|||0.60|0.16|0.0009
72610086|NCT01265498|144749087|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.06||||0.01|TWO_SIDED|95.0|-0.1|-0.01|||ANCOVA|calculated using ANCOVA models, regressing change from baseline to 72 weeks on treatment group and baseline value of the outcome|obeticholic acid vs placebo|||-0.01|-0.10|0.01
72610087|NCT01265498|144749088|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.45|||<|0.0001|TWO_SIDED|95.0|0.26|0.65|||ANCOVA|calculated using ANCOVA models, regressing change from baseline to 72 weeks on treatment group and baseline value of the outcome|obeticholic acid vs placebo|||0.65|0.26|<0.0001
72610088|NCT01265498|144749089|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.02||||0.88|TWO_SIDED|95.0|-0.35|0.3|||ANCOVA|calculated using ANCOVA models, regressing change from baseline to 72 weeks on treatment group and baseline value of the outcome|obeticholic acid vs placebo|||0.30|-0.35|0.88
72418144|NCT03318523|144346599|SUPERIORITY|Adjusted mean, difference with placebo, 95% CI, and p-value were based on an MMRM model, with change from baseline in MDS-UPDRS score as dependent variable and with fixed effects of treatment group, time, treatment group-by-time interaction, region, PD subtype, prior use of PD medication, baseline MDS-UPDRS score, baseline MDS-UPDRS by time interaction, baseline striatum SBR values and baseline striatum SBR value by time interaction.|Difference|0.13||||0.8155|TWO_SIDED|95.0|-0.965|1.225|||Mixed Model for Repeated Measures|||Change from Baseline in MDS-UPDRS Subpart I Score at Week 52||1.225|-0.965|0.8155
72418145|NCT03318523|144346599|SUPERIORITY|Adjusted mean, difference with placebo, 95% CI, and p-value were based on an MMRM model, with change from baseline in MDS-UPDRS score as dependent variable and with fixed effects of treatment group, time, treatment group-by-time interaction, region, PD subtype, prior use of PD medication, baseline MDS-UPDRS score, baseline MDS-UPDRS by time interaction, baseline striatum SBR values and baseline striatum SBR value by time interaction.|Difference|0.22||||0.7015|TWO_SIDED|95.0|-0.899|1.334|||Mixed Model for Repeated Measures|||Change from Baseline in MDS-UPDRS Subpart I Score at Week 52||1.334|-0.899|0.7015
72418146|NCT03318523|144346600|SUPERIORITY|Adjusted mean, difference with delayed start group, 95% CI, and p-value were based on an MMRM model, with change from baseline in MDS-UPDRS score as dependent variable and with fixed effects of treatment group, time, treatment group-by-time interaction, region, PD subtype, prior use of PD medication, corresponding baseline MDS-UPDRS score, corresponding baseline MDS-UPDRS by time interaction, baseline striatum SBR values and baseline striatum SBR value by time interaction.|Difference|-1.03||||0.1038|TWO_SIDED|95.0|-2.276|0.213|||Mixed Model for Repeated Measures|||Change from Baseline in MDS-UPDRS Subpart I Score at Week 72||0.213|-2.276|0.1038
72610089|NCT01265498|144749090|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.4||||0.72|TWO_SIDED|95.0|-1.8|2.6|||ANCOVA|calculated using ANCOVA models, regressing change from baseline to 72 weeks on treatment group and baseline value of the outcome|obeticholic acid vs placebo|||2.6|-1.8|0.72
72610090|NCT01265498|144749091|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0||||0.71|TWO_SIDED|95.0|-0.01|0.01|||ANCOVA|calculated using ANCOVA models, regressing change from baseline to 72 weeks on treatment group and baseline value of the outcome|obeticholic acid vs placebo|||0.01|-0.01|0.71
72610091|NCT01265498|144749092|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.1||||0.002|TWO_SIDED|95.0|-1.8|-0.4|||ANCOVA|calculated using ANCOVA models, regressing change from baseline to 72 weeks on treatment group and baseline value of the outcome|obeticholic acid vs placebo|||-0.4|-1.8|0.002
72418147|NCT03318523|144346600|SUPERIORITY|Adjusted mean, difference with delayed start group, 95% CI, and p-value were based on an MMRM model, with change from baseline in MDS-UPDRS score as dependent variable and with fixed effects of treatment group, time, treatment group-by-time interaction, region, PD subtype, prior use of PD medication, corresponding baseline MDS-UPDRS score, corresponding baseline MDS-UPDRS by time interaction, baseline striatum SBR values and baseline striatum SBR value by time interaction.|Difference|0.09||||0.8689|TWO_SIDED|95.0|-0.933|1.103|||Mixed Model for Repeated Measures|||Change from Baseline in MDS-UPDRS Subpart I Score at Week 72||1.103|-0.933|0.8689
72610092|NCT01265498|144749093|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.1||||0.4|TWO_SIDED|95.0|-0.2|0.4|||ANCOVA|calculated using ANCOVA models, regressing change from baseline to 72 weeks on treatment group and baseline value of the outcome|obeticholic acid vs placebo|||0.4|-0.2|0.40
72610093|NCT01265498|144749094|SUPERIORITY_OR_OTHER||Mean Difference (Net)|16.0||||0.001|TWO_SIDED|95.0|7.0|26.0|||ANCOVA|calculated using ANCOVA models, regressing change from baseline to 72 weeks on treatment group and baseline value of the outcome|obeticholic acid vs placebo|||26|7|0.001
72418148|NCT03318523|144346600|SUPERIORITY|Adjusted mean, difference with delayed start group, 95% CI, and p-value were based on an MMRM model, with change from baseline in MDS-UPDRS score as dependent variable and with fixed effects of treatment group, time, treatment group-by-time interaction, region, PD subtype, prior use of PD medication, corresponding baseline MDS-UPDRS score, corresponding baseline MDS-UPDRS by time interaction, baseline striatum SBR values and baseline striatum SBR value by time interaction.|Difference|-0.01||||0.982|TWO_SIDED|95.0|-1.026|1.003|||Mixed Model for Repeated Measures|||Change from Baseline in MDS-UPDRS Subpart I Score at Week 72||1.003|-1.026|0.9820
72610094|NCT01265498|144749095|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.7||||0.03|TWO_SIDED|95.0|-1.4|-0.1|||ANCOVA|calculated using ANCOVA models, regressing change from baseline to 72 weeks on treatment group and baseline value of the outcome|obeticholic acid vs placebo|||-0.1|-1.4|0.03
72610095|NCT01265498|144749096|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.02||||0.04|TWO_SIDED|95.0|0.0|0.04|||ANCOVA|calculated using ANCOVA models, regressing change from baseline to 72 weeks on treatment group and baseline value of the outcome|obeticholic acid vs placebo|||0.04|0.00|0.04
72610096|NCT01265498|144749097|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.01||||0.53|TWO_SIDED|95.0|-0.03|0.05|||ANCOVA|calculated using ANCOVA models, regressing change from baseline to 72 weeks on treatment group and baseline value of the outcome|obeticholic acid vs placebo|||0.05|-0.03|0.53
72610097|NCT01265498|144749098|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.6||||0.03|TWO_SIDED|95.0|0.2|5.0|||ANCOVA|calculated using ANCOVA models, regressing change from baseline to 72 weeks on treatment group and baseline value of the outcome|obeticholic acid vs placebo|||5.0|0.2|0.03
72610098|NCT01265498|144749099|SUPERIORITY_OR_OTHER||Mean Difference (Net)|14.0||||0.05|TWO_SIDED|95.0|0.0|29.0|||ANCOVA|calculated using ANCOVA models, regressing change from baseline to 72 weeks on treatment group and baseline value of the outcome|obeticholic acid vs placebo|||29|0|0.05
72610099|NCT01265498|144749100|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.5||||0.13|TWO_SIDED|95.0|-1.2|0.2|||ANCOVA|calculated using ANCOVA models, regressing change from baseline to 72 weeks on treatment group and baseline value of the outcome|obeticholic acid vs placebo|||0.2|-1.2|0.13
72610100|NCT01265498|144749101|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.5||||0.31|TWO_SIDED|95.0|-0.5|1.6|||ANCOVA|calculated using ANCOVA models, regressing change from baseline to 72 weeks on treatment group and baseline value of the outcome|obeticholic acid vs placebo|||1.6|-0.5|0.31
72610101|NCT01265498|144749102|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.2||||0.16|TWO_SIDED|95.0|-0.6|0.1|||ANCOVA|calculated using ANCOVA models, regressing change from baseline to 72 weeks on treatment group and baseline value of the outcome|obeticholic acid vs placebo|||0.1|-0.6|0.16
72610102|NCT01265498|144749103|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.02||||0.002|TWO_SIDED|95.0|-0.04|-0.01|||ANCOVA|calculated using ANCOVA models, regressing change from baseline to 72 weeks on treatment group and baseline value of the outcome|obeticholic acid vs placebo|||-0.01|-0.04|0.002
72610103|NCT01265498|144749104|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.3||||0.26|TWO_SIDED|95.0|-0.2|0.8|||ANCOVA|calculated using ANCOVA models, regressing change from baseline to 72 weeks on treatment group and baseline value of the outcome|obeticholic acid vs placebo|||0.8|-0.2|0.26
72610104|NCT01265498|144749105|SUPERIORITY_OR_OTHER||Mean Difference (Net)|38.0||||0.02|TWO_SIDED|95.0|6.0|69.0|||ANCOVA|calculated using ANCOVA models, regressing change from baseline to 72 weeks on treatment group and baseline value of the outcome|obeticholic acid vs placebo|||69|6|0.02
72610105|NCT01265498|144749106|SUPERIORITY_OR_OTHER||Mean Difference (Net)|13.0||||0.01|TWO_SIDED|95.0|3.0|23.0|||ANCOVA|calculated using ANCOVA models, regressing change from baseline to 72 weeks on treatment group and baseline value of the outcome|obeticholic acid vs placebo|||23|3|0.01
72610106|NCT01265498|144749107|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.4||||0.71|TWO_SIDED|95.0|-1.7|2.6|||ANCOVA|calculated using ANCOVA models, regressing change from baseline to 72 weeks on treatment group and baseline value of the outcome|obeticholic acid vs placebo|||2.6|-1.7|0.71
72610107|NCT01265498|144749108|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.2||||0.008|TWO_SIDED|95.0|-3.7|-0.6|||ANCOVA|calculated using ANCOVA models, regressing change from baseline to 72 weeks on treatment group and baseline value of the outcome|obeticholic acid vs placebo|||-0.6|-3.7|0.008
72610108|NCT01265498|144749109|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.7||||0.01|TWO_SIDED|95.0|-1.3|-0.2|||ANCOVA|calculated using ANCOVA models, regressing change from baseline to 72 weeks on treatment group and baseline value of the outcome|obeticholic acid vs placebo|||-0.2|-1.3|0.01
72610109|NCT01265498|144749110|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.4||||0.7|TWO_SIDED|95.0|-2.2|1.5|||ANCOVA|calculated using ANCOVA models, regressing change from baseline to 72 weeks on treatment group and baseline value of the outcome|obeticholic acid vs placebo|||1.5|-2.2|0.70
72610110|NCT01265498|144749111|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0||||0.57|TWO_SIDED|95.0|-0.01|0.02|||ANCOVA|calculated using ANCOVA models, regressing change from baseline to 72 weeks on treatment group and baseline value of the outcome|obeticholic acid vs placebo|||0.02|-0.01|0.57
72610111|NCT01265498|144749112|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.0||||0.05|TWO_SIDED|95.0|-7.0|0.0|||ANCOVA|calculated using ANCOVA models, regressing change from baseline to 72 weeks on treatment group and baseline value of the outcome|obeticholic acid vs placebo|||0|-7|0.05
72610112|NCT01265498|144749113|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.0||||0.23|TWO_SIDED|95.0|-4.0|1.0|||ANCOVA|calculated using ANCOVA models, regressing change from baseline to 72 weeks on treatment group and baseline value of the outcome|obeticholic acid vs placebo|||1|-4|0.23
72610113|NCT01265498|144749114|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.0||||0.22|TWO_SIDED|95.0|-1.0|3.0|||ANCOVA|calculated using ANCOVA models, regressing change from baseline to 72 weeks on treatment group and baseline value of the outcome|obeticholic acid vs placebo|||3|-1|0.22
72610114|NCT01265498|144749115|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0||||0.65|TWO_SIDED|95.0|-3.0|2.0|||ANCOVA|calculated using ANCOVA models, regressing change from baseline to 72 weeks on treatment group and baseline value of the outcome|obeticholic acid vs placebo|||2|-3|0.65
72610115|NCT03880474|144749164|OTHER||Relative Risk|1.52||||0.1146|TWO_SIDED|95.0|0.9|2.55|||Log Binominal Model|||||2.55|0.90|0.1146
72610116|NCT03880474|144749164|OTHER||Relative Risk|1.52||||0.1146|TWO_SIDED|95.0|0.9|2.55|||Poisson Model with Robust Variance|||||2.55|0.90|0.1146
72610117|NCT03880474|144749165|OTHER||Relative Risk|1.0||||1|TWO_SIDED|95.0|0.86|1.15|||Log Binomial Model|||The Analysis concerns the Incidence of Influenza-like Illness (ILI)||1.15|0.86|1.0000
72610118|NCT03880474|144749165|OTHER||Relative Risk|1.0||||0.9799|TWO_SIDED|95.0|0.86|1.15|||Poisson Model with Robust Variance|||The Analysis concerns the Incidence of Influenza-like Illness (ILI)||1.15|0.86|0.9799
72610119|NCT03880474|144749167|OTHER||Least Squares Mean Difference|-287.1||||0.3284|TWO_SIDED|95.0|-872.75|298.59|||ANCOVA|||Titers of influenza-specific neutralizing antibodies against Influenza A/H3N2 (HI) at Day 28||298.59|-872.75|0.3284
72610120|NCT03880474|144749167|OTHER||Least Squares Mean Difference|-13.39||||0.8468|TWO_SIDED|95.0|-152.26|125.47|||ANCOVA|||Titers of influenza-specific neutralizing antibodies against Influenza A/H3N2 (HI) at Week26||125.47|-152.26|0.8468
72610121|NCT03880474|144749167|OTHER||Least Squares Mean Difference|-465.7||||0.5087|TWO_SIDED|95.0|-1875.21|943.75|||ANCOVA|||Titers of influenza-specific neutralizing antibodies against Influenza A/H3N2 (MN) at Day 28||943.75|-1875.21|0.5087
72610122|NCT03880474|144749167|OTHER||Least Squares Mean Difference|-83.68||||0.7509|TWO_SIDED|95.0|-611.67|444.32|||ANCOVA|||Titers of influenza-specific neutralizing antibodies against Influenza A/H3N2 (MN) at Week 26||444.32|-611.67|0.7509
72610123|NCT03880474|144749167|OTHER||Least Squares Mean Difference|-81.17||||0.3398|TWO_SIDED|95.0|-250.72|88.39|||ANOVA|||Titers of influenza-specific neutralizing antibodies against Influenza A/H1N1pdm at Day 28||88.39|-250.72|0.3398
72610124|NCT03880474|144749167|OTHER||Least Squares Mean Difference|26.15||||0.4154|TWO_SIDED|95.0|-37.95|90.26|||ANCOVA|||Titers of influenza-specific neutralizing antibodies against Influenza A/H1N1pdm at Week 26||90.26|-37.95|0.4154
72610125|NCT03880474|144749167|OTHER||Least Squares Mean Difference|22.84||||0.7193|TWO_SIDED|95.0|-104.5|150.18|||ANCOVA|||Titers of neutralizing antibodies against Influenza B/ Victoria at Day 28||150.18|-104.50|0.7193
72610126|NCT03880474|144749167|OTHER||Least Squares Mean Difference|52.38||||0.1496|TWO_SIDED|95.0|-19.59|124.35|||ANCOVA|||Titers of influenza-specific neutralizing antibodies against Influenza B/ Victoria at Week 26||124.35|-19.59|0.1496
72610127|NCT03880474|144749167|OTHER||Least Squares Mean Difference|-16.76||||0.9044|TWO_SIDED|95.0|-296.57|263.06|||ANCOVA|||Titers of influenza-specific neutralizing antibodies against Influenza B/Yamagata at Day 28||263.06|-296.57|0.9044
72610128|NCT03880474|144749167|OTHER||Least Squares Mean Difference|38.64||||0.4198|TWO_SIDED|95.0|-56.97|134.24|||ANCOVA|||Titers of influenza-specific neutralizing antibodies against Influenza B/Yamagata at Week 26||134.24|-56.97|0.4198
72610129|NCT03880474|144749168|OTHER||Hazard Ratio (HR)|1.08||||0.4159|TWO_SIDED|95.0|0.9|1.28|||Regression, Cox|||||1.28|0.90|0.4159
72610130|NCT03880474|144749169|OTHER||Geometric Mean Ratio (Active vs Placebo)|0.99||||0.955|TWO_SIDED|95.0|0.83|1.19|||ANOVA|||Time Weight Area Under the Curve (AUC) for Symptoms of Influenza - Symptom: Feeling Hot (AUC)||1.19|0.83|0.9550
72610131|NCT03880474|144749169|OTHER||Geometric Mean Ratio (Active vs Placebo)|1.0||||0.8933|TWO_SIDED|95.0|1.0|1.0|||ANOVA|||Time Weight Area Under the Curve (AUC) for Symptoms of Influenza - Symptom: Temperature (AUC)||1|1|0.8933
72610132|NCT03880474|144749169|OTHER||Geometric Mean Ratio (Active vs Placebo)|0.87||||0.2156|TWO_SIDED|95.0|0.7|1.09|||ANOVA|||Time Weight Area Under the Curve (AUC) for Symptoms of Influenza - Symptom: Cough (AUC)||1.09|0.7|0.2156
72610133|NCT03880474|144749169|OTHER||Geometric Mean Ratio (Active vs Placebo)|0.88||||0.2216|TWO_SIDED|95.0|0.71|1.1|||ANOVA|||Time Weight Area Under the Curve (AUC) for Symptoms of Influenza - Symptom: Sore Throat AUC||1.10|0.71|0.2216
72610134|NCT03880474|144749169|OTHER||Geometric Mean Ratio (Active vs Placebo)|0.87||||0.2306|TWO_SIDED|95.0|0.69|1.09|||ANOVA|||Time Weight Area Under the Curve (AUC) for Symptoms of Influenza - Symptom: Blocked Nose AUC||1.09|0.69|0.2306
72610135|NCT03880474|144749169|OTHER||Geometric Mean Ratio (Active vs Placebo)|0.99||||0.8038|TWO_SIDED|95.0|0.97|1.13|||ANOVA|||Time Weight Area Under the Curve (AUC) for Symptoms of Influenza - Symptom: Chest Pain AUC||1.13|0.97|0.8038
72610136|NCT03880474|144749169|OTHER||Geometric Mean Ratio (Active vs Placebo)|1.01||||0.9319|TWO_SIDED|95.0|0.84|1.21|||ANOVA|||Time Weight Area Under the Curve (AUC) for Symptoms of Influenza - Symptom: Muscle Pain AUC||1.21|0.84|0.9319
72610137|NCT03880474|144749169|OTHER||Geometric Mean Ratio (Active vs Placebo)|1.01||||0.8399|TWO_SIDED|95.0|0.86|1.19|||ANOVA|||Time Weight Area Under the Curve (AUC) for Symptoms of Influenza - Symptom: Shortness of Breath AUC||1.19|0.86|0.8399
72610138|NCT03880474|144749170|OTHER||Least Squares Mean Difference|743.78||||0|TWO_SIDED|95.0|443.71|1043.84|||ANCOVA|||Statistical analysis was performed for Total(NP+M) (SFU/10\^6 PBMC) at Day 28 Nucleoprotein = NP, matrix1 = M1||1043.84|443.71|0
72610139|NCT03880474|144749170|OTHER||Least Squares Mean Difference|177.1||||0.0673|TWO_SIDED|95.0|-13.14|367.33|||ANCOVA|||Statistical analysis was performed for Total(NP+M) (SFU/10\^6 PBMC) at Week 26 Nucleoprotein = NP, matrix1 = M1||367.33|-13.14|0.0673
72610140|NCT00921024|144749171|SUPERIORITY_OR_OTHER||Risk Difference (RD)|6.8|||||TWO_SIDED|||||||||||||
72610141|NCT00921024|144749172|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-7.1|||||TWO_SIDED|||||||||||||
72610142|NCT04030598|144749219|SUPERIORITY||Percentage Difference|-90.0||||0.001|TWO_SIDED|95.0|-96.0|-76.0|||Wald Chi-Square||The percentage difference in mean investigator-confirmed HAE attack rate between donidalorsen 80 mg and placebo was calculated as 100 percentage (%) × (mean rate ratio -1).|||-76.00|-96.00|0.001
72610143|NCT04030598|144749220|SUPERIORITY||Percentage Difference|-89.0||||0.003|TWO_SIDED|95.0|-95.0|-77.0|||Wald Chi-Square||The percentage difference in mean investigator-confirmed HAE attack rate between donidalorsen 80 mg and placebo was calculated as 100% × (mean rate ratio -1).|||-77.00|-95.00|0.003
72610144|NCT04030598|144749221|SUPERIORITY||Percentage Difference|-96.0||||0.004|TWO_SIDED|95.0|-100.0|-65.0|||Wald Chi-Square||The percentage difference in mean investigator-confirmed HAE attack rate between donidalorsen 80 mg and placebo was calculated as 100% × (mean rate ratio -1).|||-65.00|-100.00|0.004
72610145|NCT04030598|144749222|SUPERIORITY||Risk Difference (RD)|66.7||||0.004|TWO_SIDED|95.0|17.5|95.7|||Fisher Exact|||For ≥ 50% reduction from Baseline in the HAE attack rate.||95.7|17.5|0.004
72610146|NCT04030598|144749222|SUPERIORITY||Risk Difference (RD)|75.6||||0.003|TWO_SIDED|95.0|26.8|96.5|||Fisher Exact|||For ≥ 70% reduction from Baseline in the HAE attack rate.||96.5|26.8|0.003
72610147|NCT04030598|144749222|SUPERIORITY||Risk Difference (RD)|92.3|||<|0.001|TWO_SIDED|95.0|48.0|99.8|||Fisher Exact|||For ≥ 90% reduction from Baseline in the HAE attack rate.||99.8|48.0|<0.001
72610148|NCT04030598|144749223|SUPERIORITY||Percentage Difference|-95.0||||0.009|TWO_SIDED|95.0|-99.0|-52.0|||Wald Chi-Square|||||-52.00|-99.00|0.009
72610149|NCT04030598|144749226|SUPERIORITY||Risk Difference (RD)|-14.3||||1|TWO_SIDED|95.0|-59.1|33.9|||Fisher Exact|||Week 9||33.9|-59.1|1.000
72610150|NCT04030598|144749226|SUPERIORITY||Risk Difference (RD)|-21.4||||0.521|TWO_SIDED|95.0|-64.9|27.1|||Fisher Exact|||Week 17||27.1|-64.9|0.521
72610151|NCT04030598|144749227|SUPERIORITY||Treatment Difference|-25.92|||||TWO_SIDED|95.0|-37.1|-14.74||||||Week 9||-14.74|-37.10|
72610152|NCT04030598|144749227|SUPERIORITY||Treatment Difference|-20.69|||||TWO_SIDED|95.0|-32.7|-8.68||||||Week 17||-8.68|-32.70|
72610153|NCT00032591|144749235|NON_INFERIORITY_OR_EQUIVALENCE|A target of 363 patients with primary events required to discern a 32% relative drop in annual primary event rates with 90% power (from 5.5% for HQACM to 3.75% for PST) was based on a sample size of 3200 patients with 1 year of enrollment and a minimum of 2 years follow-up. Due to slower than planned enrollment, we randomized 2922 patients over 2.75 years, with a mean follow-up of 3 years.|Hazard Ratio (HR)|0.88||||0.14|||||||Log Rank|||The null hypothesis was the hazard ratio was equal to 1.||||0.14
72610154|NCT01258374|144749243|OTHER||||||<|0.01||||||The PK paramaters reported as geometric means, were calculated using noncompartmental modelinf techniques (WinNolin; Pharsight Corporation, Mountain View, CA)|Noncompartmental modeling techniques||||The pharmacokinetic parameters calculated for DRV, RTV and RAL were trough plasma concentration (C trough), defined as the concentration at 24 or 12 h after observed dose, the maximum observed plasma concentration (C max), the area under the plasma concentration-time curve from 0 to 24 H (AUC 0-24) or 0 to 12 h (AUC 0-12) and the elimination half-life (t1/2). AUC and t1/2 were calculated using non using noncompartmental modeling techniques (WinNolin; Pharsight Corporation, Mountain View, CA). All of these PK parameters are reported as geometric means.|||<0.01
72610155|NCT01799941|144749257|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||One sample t-test|||The primary analysis tested the null hypothesis that the mean change in CNS-LS score from Baseline to Day 90 visit is equal to zero.||||<0.0001
72610156|NCT01799941|144749257|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||one-sample t-test|||The primary analysis tested the null hypothesis that the mean change in CNS-LS score from Baseline to Day 90 visit is equal to zero.||||<0.0001
72610157|NCT01799941|144749257|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||One-sample t-test|||The primary analysis tested the null hypothesis that the mean change in CNS-LS score from Baseline to Day 90 visit is equal to zero.||||<0.0001
72610158|NCT01799941|144749257|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||One-sample t-test|||The primary analysis tested the null hypothesis that the mean change in CNS-LS score from Baseline to Day 90 visit is equal to zero.||||<0.0001
72610159|NCT01799941|144749257|SUPERIORITY_OR_OTHER||Analysis of covariance (ANCOVA)|0.04|STANDARD_ERROR_OF_MEAN|0.72|||TWO_SIDED|95.0|-1.37|1.45|||||A positive estimate indicates a smaller change in the first group. Observations used =261.|||1.45|-1.37|
72610160|NCT01799941|144749257|SUPERIORITY_OR_OTHER||ANCOVA|1.11|STANDARD_ERROR_OF_MEAN|0.8|||TWO_SIDED|95.0|-0.46|2.68|||||A positive estimate indicates a smaller change in the first group. Observations used =261.|||2.68|-0.46|
72610161|NCT01799941|144749257|SUPERIORITY_OR_OTHER||ANCOVA|1.15|STANDARD_ERROR_OF_MEAN|0.78|||TWO_SIDED|95.0|-0.39|2.69|||||A positive estimate indicates a smaller change in the first group. Observations used =261.|||2.69|-0.39|
72610162|NCT01799941|144749258|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||One-sample t-test|||||||<0.0001
72610163|NCT01799941|144749258|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||One-sample t-test|||||||<0.0001
72610164|NCT01799941|144749258|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||One-sample t-test|||||||<0.0001
72610165|NCT01799941|144749258|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||One-sample t-test|||||||<0.0001
72610166|NCT01799941|144749259|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||One-sample t-test|||Day 30 versus Baseline||||<0.0001
72610167|NCT01799941|144749259|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||One-sample t-test|||Day 90 versus Baseline||||<0.0001
72610168|NCT01799941|144749259|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||One-sample t-test|||Day 30 versus Baseline||||<0.0001
72610169|NCT01799941|144749259|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||One-sample t-test|||Day 90 assessment||||<0.0001
72610170|NCT01799941|144749259|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||One-sample t-test|||Day 30 versus Baseline||||<0.0001
72610171|NCT01799941|144749259|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||One-sample t-test|||Day 90 versus Baseline||||<0.0001
72610172|NCT01799941|144749259|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||One-sample t-test|||Day 30 versus Baseline||||<0.0001
72610173|NCT01799941|144749259|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||One-sample t-test|||Day 90 versus Baseline||||<0.0001
72610174|NCT01799941|144749261|SUPERIORITY_OR_OTHER||Incidence Rate Ratio|0.425|STANDARD_ERROR_OF_MEAN|0.023|<|0.0001|TWO_SIDED|95.0|0.407|0.445|||Mixed Effects Poisson Regreesion Model||Number of observations = 854, Number of participants = 298|Day 30 assessment||0.445|0.407|<0.0001
72610175|NCT01799941|144749261|SUPERIORITY_OR_OTHER||Incidence Rate Ratio|0.277|STANDARD_ERROR_OF_MEAN|0.028|<|0.0001|TWO_SIDED|95.0|0.262|0.293|||Mixed Effects Poisson Regression Model||Number of observations = 854, Number of participants = 298|Day 90 assessment||0.293|0.262|<0.0001
72610176|NCT01799941|144749261|SUPERIORITY_OR_OTHER||Incidence Rate Ratio|0.5|STANDARD_ERROR_OF_MEAN|0.033|<|0.0001|TWO_SIDED|95.0|0.469|0.534|||Mixed Effects Poisson Regression Model||Number of observations = 318, Number of participants = 108|Day 30 assessment||0.534|0.469|<0.0001
72610177|NCT01799941|144749261|SUPERIORITY_OR_OTHER||Incidence Rate Ratio|0.323|STANDARD_ERROR_OF_MEAN|0.039|<|0.0001|TWO_SIDED|95.0|0.299|0.349|||Mixed Effects Poisson Regression Model||Number of observations = 318, Number of participants = 108|Day 90 assessment||0.349|0.299|<0.0001
72610178|NCT01799941|144749261|SUPERIORITY_OR_OTHER||Incidence Rate Ratio|0.351|STANDARD_ERROR_OF_MEAN|0.044|<|0.0001|TWO_SIDED|95.0|0.323|0.383|||Mixed Effects Poisson Regression Model||Number of observations = 297, Number of participants = 103|Day 30 assessment||0.383|0.323|<0.0001
72610179|NCT01799941|144749261|SUPERIORITY_OR_OTHER||Incidence Rate Ratio|0.255|STANDARD_ERROR_OF_MEAN|0.051|<|0.0001|TWO_SIDED|95.0|0.231|0.282|||Mixed Effects Poisson Regression Model||Number of observations = 297, Number of participants = 103|Day 90 assessment||0.282|0.231|<0.0001
72610180|NCT01799941|144749261|SUPERIORITY_OR_OTHER||Incidence Rate Ratio|0.387|STANDARD_ERROR_OF_MEAN|0.048|<|0.0001|TWO_SIDED|95.0|0.352|0.425|||Mixed Effects Poisson Regression Model||Number of observations = 239, Number of participants = 87|Day 30 assessment||0.425|0.352|<0.0001
72610181|NCT01799941|144749261|SUPERIORITY_OR_OTHER||Incidence Rate Ratio|0.215|STANDARD_ERROR_OF_MEAN|0.066|<|0.0001|TWO_SIDED|95.0|0.189|0.245|||Mixed Effects Poisson Regression Model||Number of observations = 239, Number of participants = 87|Day 90 assessment||0.245|0.189|<0.0001
72610182|NCT01799941|144749264|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||One-sample t-test|||||||<0.0001
72610183|NCT01799941|144749264|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||One-sample t-test|||||||<0.0001
72610184|NCT01799941|144749264|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||One-sample t-test|||||||<0.0001
72610185|NCT01799941|144749264|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||One-sample t-test|||||||<0.0001
72610186|NCT01125930|144749275|SUPERIORITY_OR_OTHER|||||||0.93|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons were done at the Week 24 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess redness.||||0.93
72610187|NCT01125930|144749276|SUPERIORITY_OR_OTHER|||||||0.79|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons were done at the Week 24 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess telangiectasia.||||0.79
72610188|NCT01125930|144749277|SUPERIORITY_OR_OTHER|||||||0.94|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values to address non-normality of data.||Group comparisons were done at the Week 2 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other.||||0.94
72610189|NCT01125930|144749277|SUPERIORITY_OR_OTHER|||||||0.57|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values to address non-normality of data.||Group comparisons were done at the Week 6 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other.||||0.57
72610190|NCT01125930|144749277|SUPERIORITY_OR_OTHER|||||||0.66|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values to address non-normality of data.||Group comparisons were done at the Week 12 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other.||||0.66
72610191|NCT01125930|144749277|SUPERIORITY_OR_OTHER|||||||0.38|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values to address non-normality of data.||Group comparisons were done at the Week 18 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other.||||0.38
72610192|NCT01125930|144749277|SUPERIORITY_OR_OTHER|||||||0.24|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values to address non-normality of data.||Group comparisons were done at the Week 24 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other.||||0.24
72610193|NCT01125930|144749278|SUPERIORITY_OR_OTHER|||||||0.87|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons were done at the Week 24 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess photodamage.||||0.87
72610194|NCT01125930|144749279|SUPERIORITY_OR_OTHER|||||||1|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values||Group comparisons were done at the Week 2 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess ocular manifestations of rosacea.||||1.00
72610195|NCT01125930|144749279|SUPERIORITY_OR_OTHER|||||||0.62|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values||Group comparisons were done at the Week 6 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess ocular manifestations of rosacea||||0.62
72610196|NCT01125930|144749279|SUPERIORITY_OR_OTHER|||||||1|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank-sum test with exact p-values||Group comparisons were done at the Week 12 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess ocular manifestations of rosacea||||1.00
72610197|NCT01125930|144749279|SUPERIORITY_OR_OTHER|||||||1|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values||Group comparisons were done at the Week 18 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess ocular manifestations of rosacea||||1.00
72610198|NCT01125930|144749279|SUPERIORITY_OR_OTHER|||||||0.45|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons were done at the Week 24 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess ocular manifestations of rosacea||||0.45
72610199|NCT01125930|144749280|SUPERIORITY_OR_OTHER|||||||0.53|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons were done at the Week 2 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess phymatous changes of rosacea.||||0.53
72610200|NCT01125930|144749280|SUPERIORITY_OR_OTHER|||||||0.53|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons were done at the Week 6 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess phymatous changes of rosacea.||||0.53
72610201|NCT01125930|144749280|SUPERIORITY_OR_OTHER|||||||0.53|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values||Group comparisons were done at the Week 12 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess phymatous changes of rosacea.||||0.53
72610202|NCT01125930|144749280|SUPERIORITY_OR_OTHER|||||||0.53|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons were done at the Week 18 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess phymatous changes of rosacea.||||0.53
72610203|NCT01125930|144749280|SUPERIORITY_OR_OTHER|||||||1|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons were done at the Week 24 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess phymatous changes of rosacea.||||1.00
72610204|NCT01125930|144749281|SUPERIORITY_OR_OTHER|||||||1|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values to address non-normality of data.||Group comparisons were done at the Week 2 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other.||||1.00
72610205|NCT01125930|144749281|SUPERIORITY_OR_OTHER|||||||0.41|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values to address non-normality of data.||Group comparisons were done at the Week 6 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other.||||0.41
72610206|NCT01125930|144749281|SUPERIORITY_OR_OTHER|||||||0.66|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values to address non-normality of data.||Group comparisons were done at the Week 12 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other.||||0.66
72326118|NCT01897532|144175796|OTHER||Hazard Ratio (HR)|1.04||||0.6918|TWO_SIDED|95.0|0.89|1.22||p-value for HR ≥1.0 (1-sided)|Regression, Cox|Based on a Cox regression model with terms for treatment group and region.||Cox proportional hazard regression model was performed to compare the effect of linagliptin versus placebo. Model included randomised treatment and geographical region as factors. Breslow's method was used for dealing with ties. First hypothesis (non-inferiority of the primary endpoint) was to be tested at the one-sided alpha-level of 2.5%. In case of significance the next set of hypotheses (two separate hypothesis tests) were to be tested with a sequentially rejective multiple test procedure.||1.22|0.89|0.6918
72610207|NCT01125930|144749281|SUPERIORITY_OR_OTHER|||||||0.92|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values to address non-normality of data.||Group comparisons were done at the Week 18 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other.||||0.92
72610208|NCT01125930|144749281|SUPERIORITY_OR_OTHER|||||||0.8|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values to address non-normality of data.||Group comparisons were done at the Week 24 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other.||||0.80
72610209|NCT01125930|144749282|SUPERIORITY_OR_OTHER|||||||0.003|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons of TAC1 at Week 24 visit were made using fold change data.||||0.003
72610210|NCT01125930|144749282|SUPERIORITY_OR_OTHER|||||||0.35|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons of CXCR4 at Week 24 visit were made using fold change data.||||0.35
72610211|NCT01125930|144749282|SUPERIORITY_OR_OTHER|||||||0.68|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons of CXCL12 at Week 24 visit were made using fold change data.||||0.68
72610212|NCT01125930|144749282|SUPERIORITY_OR_OTHER|||||||0.76|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons of TNFa at Week 24 visit were made using fold change data.||||0.76
72610213|NCT01125930|144749283|SUPERIORITY_OR_OTHER|||||||1|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons of COL-1 at Week 24 visit were made using fold change data.||||1.00
72610214|NCT01125930|144749283|SUPERIORITY_OR_OTHER|||||||0.25|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons of COL-3 at Week 24 visit were made using fold change data.||||0.25
72610215|NCT01125930|144749283|SUPERIORITY_OR_OTHER|||||||0.41|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons of MMP-1 at Week 24 visit were made using fold change data.||||0.41
72610216|NCT01125930|144749283|SUPERIORITY_OR_OTHER|||||||0.02|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons of MMP-3 at Week 24 visit were made using fold change data.||||0.02
72610217|NCT01125930|144749283|SUPERIORITY_OR_OTHER|||||||0.61|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons of MMP-9 at Week 24 visit were made using fold change data.||||0.61
72610218|NCT01125930|144749284|SUPERIORITY_OR_OTHER|||||||1|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values||Group comparisons were done at the Week 2 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess redness.||||1.00
72610219|NCT01125930|144749284|SUPERIORITY_OR_OTHER|||||||0.44|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values||Group comparisons were done at the Week 6 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess redness.||||0.44
72610220|NCT01125930|144749284|SUPERIORITY_OR_OTHER|||||||0.41|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values||Group comparisons were done at the Week 12 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess redness.||||0.41
72326119|NCT00038948|144175799|SUPERIORITY_OR_OTHER||Weighted difference|-2.68||||0.575||95.0|-12.27|6.91||Analysis of covariance p-value|ANCOVA||Data was adjusted for baseline and center.|Baseline GFR of 20.0 to 40.0 mL/min||6.91|-12.27|0.575
72610221|NCT01125930|144749284|SUPERIORITY_OR_OTHER|||||||0.94|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values||Group comparisons were done at the Week 18 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess redness.||||0.94
72610222|NCT01125930|144749285|SUPERIORITY_OR_OTHER|||||||0.15|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons were done at the Week 24 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess facial edema.||||0.15
72610223|NCT01125930|144749286|SUPERIORITY_OR_OTHER|||||||0.13|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons were done at the Week 24 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess dry skin.||||0.13
72610224|NCT01125930|144749287|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||Group comparison at Week 24 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other.||||1.00
72610225|NCT01125930|144749288|SUPERIORITY_OR_OTHER|||||||0.75|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons were done at the Week 24 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess self-reported facial burning.||||0.75
72610226|NCT01125930|144749289|SUPERIORITY_OR_OTHER|||||||0.68|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons were done at the Week 24 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess self-reported facial stinging.||||0.68
72326120|NCT00038948|144175799|SUPERIORITY_OR_OTHER||Weighted difference|1.31||||0.278||95.0|-1.06|3.69||Analysis of covariance p-value|ANCOVA||Data was adjusted for baseline and center.|Baseline GFR of \>40.0 mL/min||3.69|-1.06|0.278
72326121|NCT00038948|144175800|SUPERIORITY_OR_OTHER|||||||0.135||||||Tests the equality of rates between treatments across strata at 52 weeks.|Cochran-Mantel-Haenszel|||52 weeks statistical analysis across strata||||0.135
72326122|NCT00038948|144175800|SUPERIORITY_OR_OTHER|||||||0.559||||||Tests the equality of rates between treatments across strata at 104 weeks.|Cochran-Mantel-Haenszel|||104 weeks statistical analysis across strata||||0.559
72326123|NCT03682965|144175801|SUPERIORITY|||||||0.004|||||||Kruskal-Wallis|||||||0.004
72326124|NCT03682965|144175802|SUPERIORITY||||||<|0.05||||||The Holm-Bonferroni correction for multiple tests was used because the two outcomes are based on correlated data.|Clopper-Pearson binomial exact test|||The secondary efficacy endpoint was the percentage of days during peak pollen season for which the average total combined score was lower in the immunotherapy group than in the placebo group.||||<0.05
72326125|NCT03682965|144175804|SUPERIORITY|||||||0.23|||||||Wilcoxon (Mann-Whitney)|||||||0.23
72326126|NCT04472650|144175825|OTHER||Ratio of Geometric Least Squares Means|87.63|||||TWO_SIDED|90.0|78.273|98.111||||||Sitravatinib Malate Salt Capsule (Test) vs. Sitravatinib Free Base Capsule (Reference). Analysis based on Relative Bioavailability Analysis Set, defined as the subset of participants in the PK Parameters Analysis Set who had at least 1 primary PK parameter (AUC0-t, AUC0-inf and Cmax of sitravatinib) in both periods.||98.111|78.273|
72326127|NCT04472650|144175826|OTHER||Ratio of Geometric Least Squares Means|87.5|||||TWO_SIDED|90.0|78.12|98.01||||||Sitravatinib Malate Salt Capsule (Test) vs. Sitravatinib Free Base Capsule (Reference). Analysis based on Relative Bioavailability Analysis Set, defined as the subset of participants in the PK Parameters Analysis Set who had at least 1 primary PK parameter (AUC0-t, AUC0-inf and Cmax of sitravatinib) in both periods.||98.01|78.12|
72326128|NCT04472650|144175827|OTHER||Ratio of Geometric Least Squares Means|88.8|||||TWO_SIDED|90.0|77.41|101.87||||||Sitravatinib Malate Salt Capsule (Test) vs. Sitravatinib Free Base Capsule (Reference). Analysis based on Relative Bioavailability Analysis Set, defined as the subset of participants in the PK Parameters Analysis Set who had at least 1 primary PK parameter (AUC0-t, AUC0-inf and Cmax of sitravatinib) in both periods.||101.87|77.41|
72326129|NCT01861665|144175843|SUPERIORITY|||||||0.8379||||||Pre Incision vs. Post Incision on Post op day 0.|t-test, 2 sided|||||||0.8379
72326130|NCT01861665|144175843|SUPERIORITY|||||||0.7263||||||Pre incision vs. Post incision post op day 1.|t-test, 2 sided|||||||0.7263
72326131|NCT01861665|144175843|SUPERIORITY|||||||0.5||||||Pre incision vs. Post incision day 2.|t-test, 2 sided|||||||0.5
72326132|NCT02722408|144175844|OTHER|||||||0.0041||||||Mixed-effects model for repeated measures analysis with percent change in LDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||||||0.0041
72326133|NCT02722408|144175845|OTHER|||||||0.001||||||Mixed-effects model for repeated measures analysis with percent change in LDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||||||0.0010
72326134|NCT02722408|144175846|OTHER|||||||0.0012||||||Mixed-effects model for repeated measures analysis with percent change in LDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||||||0.0012
72326135|NCT02722408|144175847|OTHER|||||||0.056||||||Mixed-effects model for repeated measures analysis with Change in LDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28||||0.0560
72326136|NCT02722408|144175847|OTHER|||||||0.0219||||||Mixed-effects model for repeated measures analysis with Change in LDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56||||0.0219
72326137|NCT02722408|144175847|OTHER|||||||0.0286||||||Mixed-effects model for repeated measures analysis with Change in LDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84||||0.0286
72326138|NCT02722408|144175848|OTHER|||||||0.0058||||||Mixed-effects model for repeated measures analysis with percent change in Non-HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28||||0.0058
72326139|NCT02722408|144175848|OTHER|||||||0.0019||||||Mixed-effects model for repeated measures analysis with percent change in Non-HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56||||0.0019
72326140|NCT02722408|144175848|OTHER|||||||0.0024||||||Mixed-effects model for repeated measures analysis with percent change in Non-HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84||||0.0024
72326141|NCT02722408|144175849|OTHER|||||||0.0592||||||Mixed-effects model for repeated measures analysis with change in Non-HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28||||0.0592
72326142|NCT02722408|144175849|OTHER|||||||0.0266||||||Mixed-effects model for repeated measures analysis with change in Non-HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56||||0.0266
72326143|NCT02722408|144175849|OTHER|||||||0.0336||||||Mixed-effects model for repeated measures analysis with change in Non-HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84||||0.0336
72326144|NCT02722408|144175850|OTHER|||||||0.0057||||||Mixed-effects model for repeated measures analysis with percent change in TC as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28||||0.0057
72326145|NCT02722408|144175850|OTHER|||||||0.0017||||||Mixed-effects model for repeated measures analysis with percent change in TC as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56||||0.0017
72326146|NCT02722408|144175850|OTHER|||||||0.0017||||||Mixed-effects model for repeated measures analysis with percent change in TC as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84||||0.0017
72326147|NCT02722408|144175851|OTHER|||||||0.0057||||||Mixed-effects model for repeated measures analysis with change in TC as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28||||0.0057
72326148|NCT02722408|144175851|OTHER|||||||0.0255||||||Mixed-effects model for repeated measures analysis with change in TC as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56||||0.0255
72326149|NCT02722408|144175851|OTHER|||||||0.0312||||||Mixed-effects model for repeated measures analysis with change in TC as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 86||||0.0312
72326150|NCT02722408|144175852|OTHER|||||||0.4489||||||Mixed-effects model for repeated measures analysis with percent change in TG as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28||||0.4489
72326151|NCT02722408|144175852|OTHER|||||||0.5964||||||Mixed-effects model for repeated measures analysis with percent change in TG as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 84||||0.5964
72326152|NCT02722408|144175852|OTHER|||||||0.6785||||||Mixed-effects model for repeated measures analysis with percent change in TG as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84||||0.6785
72326153|NCT02722408|144175853|OTHER|||||||0.2177||||||Mixed-effects model for repeated measures analysis with change in TG as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300mg: Day 28||||0.2177
72326154|NCT02722408|144175853|OTHER|||||||0.3209||||||Mixed-effects model for repeated measures analysis with change in TG as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600mg: Day 56||||0.3209
72326155|NCT02722408|144175853|OTHER|||||||0.3101||||||Mixed-effects model for repeated measures analysis with change in TG as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900mg: Day 84||||0.3101
72326156|NCT02722408|144175854|OTHER|||||||0.0057||||||Mixed-effects model for repeated measures analysis with percent change in HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28||||0.0057
72326157|NCT02722408|144175854|OTHER|||||||0.0022||||||Mixed-effects model for repeated measures analysis with percent change in HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56||||0.0022
72326158|NCT02722408|144175854|OTHER|||||||0.0029||||||Mixed-effects model for repeated measures analysis with percent change in HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84||||0.0029
72326159|NCT02722408|144175855|OTHER|||||||0.0008||||||Mixed-effects model for repeated measures analysis with change in HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300mg: Day 28||||0.0008
72326160|NCT02722408|144175855|OTHER|||||||0.0005||||||Mixed-effects model for repeated measures analysis with change in HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600mg: Day 56||||0.0005
72326161|NCT02722408|144175855|OTHER|||||||0.0002||||||Mixed-effects model for repeated measures analysis with change in HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900mg: Day 84||||0.0002
72610227|NCT01125930|144749290|SUPERIORITY_OR_OTHER|||||||0.77|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons were done at the Week 24 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to provide an overall self-assessment of product tolerance.||||0.77
72326162|NCT02722408|144175856|OTHER|||||||0.4103||||||Mixed-effects model for repeated measures analysis with percent change in VLDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28||||0.4103
72326163|NCT02722408|144175856|OTHER|||||||0.6164||||||Mixed-effects model for repeated measures analysis with percent change in VLDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56||||0.6164
72326164|NCT02722408|144175856|OTHER|||||||0.6732||||||Mixed-effects model for repeated measures analysis with percent change in VLDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84||||0.6732
72326165|NCT02722408|144175857|OTHER|||||||0.2003||||||Mixed-effects model for repeated measures analysis with change in VLDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300mg: Day 28||||0.2003
72326166|NCT02722408|144175857|OTHER|||||||0.3323||||||Mixed-effects model for repeated measures analysis with change in VLDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600mg: Day 56||||0.3323
72326167|NCT02722408|144175857|OTHER|||||||0.3047||||||Mixed-effects model for repeated measures analysis with change in VLDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900mg: Day 84||||0.3047
72610228|NCT01125930|144749291|SUPERIORITY_OR_OTHER|||||||0.41|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values||Group comparisons were done at the Week 2 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess telangiectasia.||||0.41
72610229|NCT01125930|144749291|SUPERIORITY_OR_OTHER|||||||1|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values||Group comparisons were done at the Week 6 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess telangiectasia.||||1.00
72610230|NCT01125930|144749291|SUPERIORITY_OR_OTHER|||||||0.96|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values||Group comparisons were done at the Week 12 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess telangiectasia.||||0.96
72610231|NCT01125930|144749291|SUPERIORITY_OR_OTHER|||||||0.91|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values||Group comparisons were done at the Week 18 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess telangiectasia.||||0.91
72610232|NCT01125930|144749292|SUPERIORITY_OR_OTHER|||||||0.29|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values||Group comparisons were done at the Week 2 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess facial edema.||||0.29
72610233|NCT01125930|144749292|SUPERIORITY_OR_OTHER|||||||0.29|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values||Group comparisons were done at the Week 6 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess facial edema.||||0.29
72610234|NCT01125930|144749292|SUPERIORITY_OR_OTHER|||||||0.15|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values||Group comparisons were done at the Week 12 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess facial edema.||||0.15
72610235|NCT01125930|144749292|SUPERIORITY_OR_OTHER|||||||0.29|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values||Group comparisons were done at the Week 18 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess facial edema.||||0.29
72610236|NCT01125930|144749293|SUPERIORITY_OR_OTHER|||||||0.54|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values||Group comparisons were done at the Week 2 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess dry skin.||||0.54
72610237|NCT01125930|144749293|SUPERIORITY_OR_OTHER|||||||0.06|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values||Group comparisons were done at the Week 6 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess dry skin.||||0.06
72610238|NCT01125930|144749293|SUPERIORITY_OR_OTHER|||||||0.02|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values||Group comparisons were done at the Week 12 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess dry skin.||||0.02
72610239|NCT01125930|144749293|SUPERIORITY_OR_OTHER|||||||0.09|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values||Group comparisons were done at the Week 18 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess dry skin.||||0.09
72610240|NCT01125930|144749294|SUPERIORITY_OR_OTHER|||||||0.18|||||||Fisher Exact|||Group comparison at Week 2 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have different values than the other.||||0.18
72610241|NCT01125930|144749294|SUPERIORITY_OR_OTHER|||||||0.7|||||||Fisher Exact|||Group comparison at Week 6 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have different values than the other.||||0.70
72610242|NCT01125930|144749294|SUPERIORITY_OR_OTHER|||||||0.7|||||||Fisher Exact|||Group comparison at Week 12 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have different values than the other.||||0.70
72610243|NCT01125930|144749294|SUPERIORITY_OR_OTHER|||||||0.35|||||||Fisher Exact|||Group comparison at Week 18 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have different values than the other.||||0.35
72610244|NCT01125930|144749295|SUPERIORITY_OR_OTHER|||||||0.8|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons were done at the Week 2 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess self-reported facial burning.||||0.80
72610245|NCT01125930|144749295|SUPERIORITY_OR_OTHER|||||||0.31|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons were done at the Week 6 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess self-reported facial burning.||||0.31
72610246|NCT01125930|144749295|SUPERIORITY_OR_OTHER|||||||0.25|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons were done at the Week 12 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess self-reported facial burning.||||0.25
72418149|NCT03318523|144346600|SUPERIORITY|Adjusted mean, difference with delayed start group, 95% CI, and p-value were based on an MMRM model, with change from baseline in MDS-UPDRS score as dependent variable and with fixed effects of treatment group, time, treatment group-by-time interaction, region, PD subtype, prior use of PD medication, corresponding baseline MDS-UPDRS score, corresponding baseline MDS-UPDRS by time interaction, baseline striatum SBR values and baseline striatum SBR value by time interaction.|Difference|-0.26||||0.693|TWO_SIDED|95.0|-1.563|1.04|||Mixed Model for Repeated Measures|||Change from Baseline in MDS-UPDRS Subpart I Score at Week 96||1.040|-1.563|0.6930
72418150|NCT03318523|144346600|SUPERIORITY|Adjusted mean, difference with delayed start group, 95% CI, and p-value were based on an MMRM model, with change from baseline in MDS-UPDRS score as dependent variable and with fixed effects of treatment group, time, treatment group-by-time interaction, region, PD subtype, prior use of PD medication, corresponding baseline MDS-UPDRS score, corresponding baseline MDS-UPDRS by time interaction, baseline striatum SBR values and baseline striatum SBR value by time interaction.|Difference|-0.03||||0.9606|TWO_SIDED|95.0|-1.053|1.001|||Mixed Model for Repeated Measures|||Change from Baseline in MDS-UPDRS Subpart I Score at Week 96||1.001|-1.053|0.9606
72418151|NCT03318523|144346600|SUPERIORITY|Adjusted mean, difference with delayed start group, 95% CI, and p-value were based on an MMRM model, with change from baseline in MDS-UPDRS score as dependent variable and with fixed effects of treatment group, time, treatment group-by-time interaction, region, PD subtype, prior use of PD medication, corresponding baseline MDS-UPDRS score, corresponding baseline MDS-UPDRS by time interaction, baseline striatum SBR values and baseline striatum SBR value by time interaction.|Difference|-0.24||||0.6512|TWO_SIDED|95.0|-1.269|0.794|||Mixed Model for Repeated Measures|||Change from Baseline in MDS-UPDRS Subpart I Score at Week 96||0.794|-1.269|0.6512
72418152|NCT03318523|144346601|SUPERIORITY|Adjusted mean, difference with placebo, 95% CI, and p-value were based on an MMRM model, with change from baseline in MDS-UPDRS score as dependent variable and with fixed effects of treatment group, time, treatment group-by-time interaction, region, PD subtype, prior use of PD medication, baseline MDS-UPDRS score, baseline MDS-UPDRS by time interaction, baseline striatum SBR values and baseline striatum SBR value by time interaction.|Difference|-0.44||||0.5497|TWO_SIDED|95.0|-1.889|1.007|||Mixed Model for Repeated Measures|||Change from Baseline in MDS-UPDRS Subpart II Score at Week 52||1.007|-1.889|0.5497
72418153|NCT03318523|144346601|SUPERIORITY|Adjusted mean, difference with placebo, 95% CI, and p-value were based on an MMRM model, with change from baseline in MDS-UPDRS score as dependent variable and with fixed effects of treatment group, time, treatment group-by-time interaction, region, PD subtype, prior use of PD medication, baseline MDS-UPDRS score, baseline MDS-UPDRS by time interaction, baseline striatum SBR values and baseline striatum SBR value by time interaction.|Difference|0.0||||0.998|TWO_SIDED|95.0|-1.2|1.197|||Mixed Model for Repeated Measures|||Change from Baseline in MDS-UPDRS Subpart II Score at Week 52||1.197|-1.200|0.9980
72418154|NCT03318523|144346601|SUPERIORITY|Adjusted mean, difference with placebo, 95% CI, and p-value were based on an MMRM model, with change from baseline in MDS-UPDRS score as dependent variable and with fixed effects of treatment group, time, treatment group-by-time interaction, region, PD subtype, prior use of PD medication, baseline MDS-UPDRS score, baseline MDS-UPDRS by time interaction, baseline striatum SBR values and baseline striatum SBR value by time interaction.|Difference|-0.15||||0.8069|TWO_SIDED|95.0|-1.374|1.07|||Mixed Model for Repeated Measures|||Change from Baseline in MDS-UPDRS Subpart II Score at Week 52||1.070|-1.374|0.8069
72418155|NCT03318523|144346602|SUPERIORITY|Adjusted mean, difference with delayed start group, 95% CI, and p-value were based on an MMRM model, with change from baseline in MDS-UPDRS score as dependent variable and with fixed effects of treatment group, time, treatment group-by-time interaction, region, PD subtype, prior use of PD medication, corresponding baseline MDS-UPDRS score, corresponding baseline MDS-UPDRS by time interaction, baseline striatum SBR values and baseline striatum SBR value by time interaction.|Difference|-0.21||||0.7968|TWO_SIDED|95.0|-1.786|1.372|||Mixed Model for Repeated Measures|||Change from Baseline in MDS-UPDRS Subpart II Score at Week 72||1.372|-1.786|0.7968
72418156|NCT03318523|144346602|SUPERIORITY|Adjusted mean, difference with delayed start group, 95% CI, and p-value were based on an MMRM model, with change from baseline in MDS-UPDRS score as dependent variable and with fixed effects of treatment group, time, treatment group-by-time interaction, region, PD subtype, prior use of PD medication, corresponding baseline MDS-UPDRS score, corresponding baseline MDS-UPDRS by time interaction, baseline striatum SBR values and baseline striatum SBR value by time interaction.|Difference|0.53||||0.4211|TWO_SIDED|95.0|-0.766|1.827|||Mixed Model for Repeated Measures|||Change from Baseline in MDS-UPDRS Subpart II Score at Week 72||1.827|-0.766|0.4211
72418157|NCT03318523|144346602|SUPERIORITY|Adjusted mean, difference with delayed start group, 95% CI, and p-value were based on an MMRM model, with change from baseline in MDS-UPDRS score as dependent variable and with fixed effects of treatment group, time, treatment group-by-time interaction, region, PD subtype, prior use of PD medication, corresponding baseline MDS-UPDRS score, corresponding baseline MDS-UPDRS by time interaction, baseline striatum SBR values and baseline striatum SBR value by time interaction.|Difference|-0.15||||0.8166|TWO_SIDED|95.0|-1.448|1.143|||Mixed Model for Repeated Measures|||Change from Baseline in MDS-UPDRS Subpart II Score at Week 72||1.143|-1.448|0.8166
72418158|NCT03318523|144346602|SUPERIORITY|Adjusted mean, difference with delayed start group, 95% CI, and p-value were based on an MMRM model, with change from baseline in MDS-UPDRS score as dependent variable and with fixed effects of treatment group, time, treatment group-by-time interaction, region, PD subtype, prior use of PD medication, corresponding baseline MDS-UPDRS score, corresponding baseline MDS-UPDRS by time interaction, baseline striatum SBR values and baseline striatum SBR value by time interaction.|Difference|-0.53||||0.5535|TWO_SIDED|95.0|-2.31|1.24|||Mixed Model for Repeated Measures|||Change from Baseline in MDS-UPDRS Subpart II Score at Week 96||1.240|-2.310|0.5535
72610247|NCT01125930|144749295|SUPERIORITY_OR_OTHER|||||||0.46|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons were done at the Week 18 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess self-reported facial burning.||||0.46
72610248|NCT01125930|144749296|SUPERIORITY_OR_OTHER|||||||0.41|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons were done at the Week 2 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess self-reported facial stinging.||||0.41
72326168|NCT02722408|144175858|OTHER|||||||0.3601||||||Mixed-effects model for repeated measures analysis with percent change in LDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28 (Negative LDLr)||||0.3601
72418159|NCT03318523|144346602|SUPERIORITY|Adjusted mean, difference with delayed start group, 95% CI, and p-value were based on an MMRM model, with change from baseline in MDS-UPDRS score as dependent variable and with fixed effects of treatment group, time, treatment group-by-time interaction, region, PD subtype, prior use of PD medication, corresponding baseline MDS-UPDRS score, corresponding baseline MDS-UPDRS by time interaction, baseline striatum SBR values and baseline striatum SBR value by time interaction.|Difference|0.52||||0.4654|TWO_SIDED|95.0|-0.881|1.922|||Mixed Model for Repeated Measures|||Change from Baseline in MDS-UPDRS Subpart II Score at Week 96||1.922|-0.881|0.4654
72418160|NCT03318523|144346602|SUPERIORITY|Adjusted mean, difference with delayed start group, 95% CI, and p-value were based on an MMRM model, with change from baseline in MDS-UPDRS score as dependent variable and with fixed effects of treatment group, time, treatment group-by-time interaction, region, PD subtype, prior use of PD medication, corresponding baseline MDS-UPDRS score, corresponding baseline MDS-UPDRS by time interaction, baseline striatum SBR values and baseline striatum SBR value by time interaction.|Difference|0.36||||0.6184|TWO_SIDED|95.0|-1.051|1.763|||Mixed Model for Repeated Measures|||Change from Baseline in MDS-UPDRS Subpart II Score at Week 96||1.763|-1.051|0.6184
72610249|NCT01125930|144749296|SUPERIORITY_OR_OTHER|||||||0.05|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons were done at the Week 6 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess self-reported facial stinging.||||0.05
72326169|NCT02722408|144175858|OTHER|||||||0.192||||||Mixed-effects model for repeated measures analysis with percent change in LDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56 (Negative LDLr)||||0.1920
72326170|NCT02722408|144175858|OTHER|||||||0.2912||||||Mixed-effects model for repeated measures analysis with percent change in LDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84 (Negative LDLr)||||0.2912
72326171|NCT02722408|144175858|OTHER||||||<|0.0001||||||Mixed-effects model for repeated measures analysis with percent change in LDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28 (Defective LDLr)||||<0.0001
72610250|NCT01125930|144749296|SUPERIORITY_OR_OTHER|||||||0.16|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons were done at the Week 12 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess self-reported facial stinging.||||0.16
72610251|NCT01125930|144749296|SUPERIORITY_OR_OTHER|||||||0.14|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons were done at the Week 18 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess self-reported facial stinging.||||0.14
72610252|NCT01125930|144749297|SUPERIORITY_OR_OTHER|||||||0.36|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons were done at the Week 2 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to provide an overall self-assessment of product tolerance.||||0.36
72610253|NCT01125930|144749297|SUPERIORITY_OR_OTHER|||||||0.88|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons were done at the Week 6 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to provide an overall self-assessment of product tolerance.||||0.88
72610254|NCT01125930|144749297|SUPERIORITY_OR_OTHER|||||||0.18|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons were done at the Week 12 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to provide an overall self-assessment of product tolerance.||||0.18
72610255|NCT01125930|144749297|SUPERIORITY_OR_OTHER|||||||0.17|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons were done at the Week 18 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to provide an overall self-assessment of product tolerance.||||0.17
72610256|NCT01125930|144749298|SUPERIORITY_OR_OTHER|||||||0.21|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons were done at the Week 2 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to provide an assessment of skin irritation by facial stinging upon product application.||||0.21
72610257|NCT01125930|144749298|SUPERIORITY_OR_OTHER||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons were done at the Week 6 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to provide an assessment of skin irritation by facial stinging upon product application.||||<0.01
72610258|NCT01125930|144749298|SUPERIORITY_OR_OTHER|||||||0.04|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons were done at the Week 12 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to provide an assessment of skin irritation by facial stinging upon product application.||||0.04
72326172|NCT02722408|144175858|OTHER||||||<|0.0001||||||Mixed-effects model for repeated measures analysis with percent change in LDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56 (Defective LDLr)||||<0.0001
72326173|NCT02722408|144175858|OTHER||||||<|0.0001||||||Mixed-effects model for repeated measures analysis with percent change in LDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84 (Defective LDLr)||||<0.0001
72326174|NCT02722408|144175858|OTHER|||||||0.0444||||||Mixed-effects model for repeated measures analysis with percent change in LDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28 (Met EAS Clinical Diagnosis of HoFH)||||0.0444
72326175|NCT02722408|144175858|OTHER|||||||0.0159||||||Mixed-effects model for repeated measures analysis with percent change in LDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56 (Met EAS Clinical Diagnosis of HoFH)||||0.0159
72326176|NCT02722408|144175858|OTHER|||||||0.0235||||||Mixed-effects model for repeated measures analysis with percent change in LDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84 (Met EAS Clinical Diagnosis of HoFH)||||0.0235
72326177|NCT02722408|144175858|OTHER|||||||0.0005||||||Mixed-effects model for repeated measures analysis with percent change in LDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28 (Not Met EAS Clinical Diagnosis of HoFH)||||0.0005
72326178|NCT02722408|144175858|OTHER|||||||0.0003||||||Mixed-effects model for repeated measures analysis with percent change in LDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56 (Not Met EAS Clinical Diagnosis of HoFH)||||0.0003
72326179|NCT02722408|144175858|OTHER|||||||0.0003||||||Mixed-effects model for repeated measures analysis with percent change in LDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84 (Not Met EAS Clinical Diagnosis of HoFH)||||0.0003
72418161|NCT03318523|144346603|SUPERIORITY|Adjusted mean, difference with placebo, 95% CI, and p-value were based on an MMRM model, with change from baseline in MDS-UPDRS score as dependent variable and with fixed effects of treatment group, time, treatment group-by-time interaction, region, PD subtype, prior use of PD medication, baseline MDS-UPDRS score, baseline MDS-UPDRS by time interaction, baseline striatum SBR values and baseline striatum SBR value by time interaction.|Difference|0.59||||0.7274|TWO_SIDED|95.0|-2.742|3.925|||Mixed Model for Repeated Measures|||Change from Baseline in MDS-UPDRS Subpart III Score at Week 52||3.925|-2.742|0.7274
72610259|NCT01125930|144749298|SUPERIORITY_OR_OTHER|||||||0.1|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons were done at the Week 18 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to provide an assessment of skin irritation by facial stinging upon product application.||||0.10
72326180|NCT02722408|144175859|OTHER|||||||0.3646||||||Mixed-effects model for repeated measures analysis: Change in LDL-C as dependent variable, visit as fixed effect, patient as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28 (Negative LDLr)||||0.3646
72326181|NCT02722408|144175859|OTHER|||||||0.1994||||||Mixed-effects model for repeated measures analysis: Change in LDL-C as dependent variable, visit as fixed effect, patient as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56 (Negative LDLr)||||0.1994
72326182|NCT02722408|144175859|OTHER|||||||0.2858||||||Mixed-effects model for repeated measures analysis: Change in LDL-C as dependent variable, visit as fixed effect, patient as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84 (Negative LDLr)||||0.2858
72326183|NCT02722408|144175859|OTHER|||||||0.0829||||||Mixed-effects model for repeated measures analysis: Change in LDL-C as dependent variable, visit as fixed effect, patient as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28 (Defective LDLr)||||0.0829
72326184|NCT02722408|144175859|OTHER|||||||0.0492||||||Mixed-effects model for repeated measures analysis: Change in LDL-C as dependent variable, visit as fixed effect, patient as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56 (Defective LDLr)||||0.0492
72326185|NCT02722408|144175859|OTHER|||||||0.0442||||||Mixed-effects model for repeated measures analysis: Change in LDL-C as dependent variable, visit as fixed effect, patient as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84 (Defective LDLr)||||0.0442
72326186|NCT02722408|144175859|OTHER|||||||0.736||||||Mixed-effects model for repeated measures analysis: Change in LDL-C as dependent variable, visit as fixed effect, patient as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28 (Met EAS Clinical Diagnosis of HoFH)||||0.7360
72326187|NCT02722408|144175859|OTHER|||||||0.6917||||||Mixed-effects model for repeated measures analysis: Change in LDL-C as dependent variable, visit as fixed effect, patient as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56 (Met EAS Clinical Diagnosis of HoFH)||||0.6917
72326188|NCT02722408|144175859|OTHER|||||||0.7131||||||Mixed-effects model for repeated measures analysis: Change in LDL-C as dependent variable, visit as fixed effect, patient as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84 (Met EAS Clinical Diagnosis of HoFH)||||0.7131
72326189|NCT02722408|144175859|OTHER|||||||0.0014||||||Mixed-effects model for repeated measures analysis: Change in LDL-C as dependent variable, visit as fixed effect, patient as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28 (Not Met EAS Clinical Diagnosis of HoFH)||||0.0014
72418162|NCT03318523|144346603|SUPERIORITY|Adjusted mean, difference with placebo, 95% CI, and p-value were based on an MMRM model, with change from baseline in MDS-UPDRS score as dependent variable and with fixed effects of treatment group, time, treatment group-by-time interaction, region, PD subtype, prior use of PD medication, baseline MDS-UPDRS score, baseline MDS-UPDRS by time interaction, baseline striatum SBR values and baseline striatum SBR value by time interaction.|Difference|0.66||||0.6385|TWO_SIDED|95.0|-2.094|3.411|||Mixed Model for Repeated Measures|||Change from Baseline in MDS-UPDRS Subpart III Score at Week 52||3.411|-2.094|0.6385
72418163|NCT03318523|144346603|SUPERIORITY|Adjusted mean, difference with placebo, 95% CI, and p-value were based on an MMRM model, with change from baseline in MDS-UPDRS score as dependent variable and with fixed effects of treatment group, time, treatment group-by-time interaction, region, PD subtype, prior use of PD medication, baseline MDS-UPDRS score, baseline MDS-UPDRS by time interaction, baseline striatum SBR values and baseline striatum SBR value by time interaction.|Difference|0.1||||0.9467|TWO_SIDED|95.0|-2.718|2.91|||Mixed Model for Repeated Measures|||Change from Baseline in MDS-UPDRS Subpart III Score at Week 52||2.910|-2.718|0.9467
72418164|NCT03318523|144346604|SUPERIORITY|Adjusted mean, difference with delayed start group, 95% CI, and p-value were based on an MMRM model, with change from baseline in MDS-UPDRS score as dependent variable and with fixed effects of treatment group, time, treatment group-by-time interaction, region, PD subtype, prior use of PD medication, corresponding baseline MDS-UPDRS score, corresponding baseline MDS-UPDRS by time interaction, baseline striatum SBR values and baseline striatum SBR value by time interaction.|Difference|0.85||||0.6112|TWO_SIDED|95.0|-2.423|4.114|||Mixed Model for Repeated Measures|||Change from Baseline in MDS-UPDRS Subpart III Score at Week 72||4.114|-2.423|0.6112
72418165|NCT03318523|144346604|SUPERIORITY|Adjusted mean, difference with delayed start group, 95% CI, and p-value were based on an MMRM model, with change from baseline in MDS-UPDRS score as dependent variable and with fixed effects of treatment group, time, treatment group-by-time interaction, region, PD subtype, prior use of PD medication, corresponding baseline MDS-UPDRS score, corresponding baseline MDS-UPDRS by time interaction, baseline striatum SBR values and baseline striatum SBR value by time interaction.|Difference|0.86||||0.527|TWO_SIDED|95.0|-1.806|3.52|||Mixed Model for Repeated Measures|||Change from Baseline in MDS-UPDRS Subpart III Score at Week 72||3.520|-1.806|0.5270
72418166|NCT03318523|144346604|SUPERIORITY|Adjusted mean, difference with delayed start group, 95% CI, and p-value were based on an MMRM model, with change from baseline in MDS-UPDRS score as dependent variable and with fixed effects of treatment group, time, treatment group-by-time interaction, region, PD subtype, prior use of PD medication, corresponding baseline MDS-UPDRS score, corresponding baseline MDS-UPDRS by time interaction, baseline striatum SBR values and baseline striatum SBR value by time interaction.|Difference|0.06||||0.9673|TWO_SIDED|95.0|-2.608|2.719|||Mixed Model for Repeated Measures|||Change from Baseline in MDS-UPDRS Subpart III Score at Week 72||2.719|-2.608|0.9673
72418167|NCT03318523|144346604|SUPERIORITY|Adjusted mean, difference with delayed start group, 95% CI, and p-value were based on an MMRM model, with change from baseline in MDS-UPDRS score as dependent variable and with fixed effects of treatment group, time, treatment group-by-time interaction, region, PD subtype, prior use of PD medication, corresponding baseline MDS-UPDRS score, corresponding baseline MDS-UPDRS by time interaction, baseline striatum SBR values and baseline striatum SBR value by time interaction.|Difference|0.65||||0.7455|TWO_SIDED|95.0|-3.274|4.569|||Mixed Model for Repeated Measures|||Change from Baseline in MDS-UPDRS Subpart III Score at Week 96||4.569|-3.274|0.7455
72610260|NCT01125930|144749299|SUPERIORITY_OR_OTHER|||||||1|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons were done at the Week 2 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to provide an assessment of skin irritation by facial itching upon product application.||||1.00
72610261|NCT01125930|144749299|SUPERIORITY_OR_OTHER|||||||0.02|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons were done at the Week 6 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to provide an assessment of skin irritation by facial itching upon product application.||||0.02
72610262|NCT01125930|144749299|SUPERIORITY_OR_OTHER|||||||0.08|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons were done at the Week 12 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to provide an assessment of skin irritation by facial itching upon product application.||||0.08
72610263|NCT01125930|144749299|SUPERIORITY_OR_OTHER|||||||0.15|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons were done at the Week 18 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to provide an assessment of skin irritation by facial itching upon product application.||||0.15
72610264|NCT01125930|144749300|SUPERIORITY_OR_OTHER|||||||0.67|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons were done at the Week 2 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to provide an assessment of skin irritation by facial burning upon product application.||||0.67
72610265|NCT01125930|144749300|SUPERIORITY_OR_OTHER|||||||0.18|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons were done at the Week 6 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to provide an assessment of skin irritation by facial burning upon product application.||||0.18
72326190|NCT02722408|144175859|OTHER|||||||0.0009||||||Mixed-effects model for repeated measures analysis: Change in LDL-C as dependent variable, visit as fixed effect, patient as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56 (Not Met EAS Clinical Diagnosis of HoFH)||||0.0009
72610266|NCT01125930|144749300|SUPERIORITY_OR_OTHER|||||||0.02|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons were done at the Week 21 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to provide an assessment of skin irritation by facial burning upon product application.||||0.02
72610267|NCT01125930|144749300|SUPERIORITY_OR_OTHER|||||||0.42|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons were done at the Week 18 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to provide an assessment of skin irritation by facial burning upon product application.||||0.42
72610268|NCT03098979|144749301|SUPERIORITY|||||||0.5183||||||Linear dose-response shape: The multiple comparison procedures (MCP) approach was applied to calculate the adjusted one-sided p-values of the contrast test.|MCP-Mod method|Dose response relationship was assessed using the MCP-Mod method combining MCP principles with modeling techniques.||||||0.5183
72610269|NCT03098979|144749301|SUPERIORITY|||||||0.33||||||Sigmoidal Emax 1 dose-response shape: The MCP approach was applied to calculate the adjusted one-sided p-values of the contrast test.|MCP-Mod method|Dose response relationship was assessed using the MCP-Mod method combining MCP principles with modeling techniques||||||0.3300
72610270|NCT03098979|144749301|SUPERIORITY|||||||0.6232||||||Sigmoidal Emax 2 dose-response shape: The MCP approach was applied to calculate the adjusted one-sided p-values of the contrast test.|MCP-Mod method|Dose response relationship was assessed using the MCP-Mod method combining MCP principles with modeling techniques||||||0.6232
72610271|NCT03098979|144749301|SUPERIORITY|||||||0.0918||||||Emax dose-response shape: The MCP approach was applied to calculate the adjusted one-sided p-values of the contrast test.|MCP-Mod method|Dose response relationship was assessed using the MCP-Mod method combining MCP principles with modeling techniques||||||0.0918
72610272|NCT03098979|144749301|SUPERIORITY|||||||0.2701||||||Quadratic dose-response shape: The MCP approach was applied to calculate the adjusted one-sided p-values of the contrast test.|MCP-Mod method|Dose response relationship was assessed using the MCP-Mod method combining MCP principles with modeling techniques||||||0.2701
72610273|NCT02369653|144749306|SUPERIORITY|||||||0.0403|||||||Cochran-Mantel-Haenszel|||||||0.0403
72610274|NCT02369653|144749307|SUPERIORITY|||||||1|||||||Cochran-Mantel-Haenszel|||||||1.0000
72610275|NCT00447083|144749358|OTHER|||||||0.1811|||||||t-test, 2 sided|||||||.1811
72610276|NCT03558516|144749377|SUPERIORITY|||||||0.315|||||||Wilcoxon (Mann-Whitney)|||||||0.315
72610277|NCT03558516|144749378|SUPERIORITY|||||||0.27|||||||Wilcoxon (Mann-Whitney)|||||||0.270
72610278|NCT03558516|144749379|SUPERIORITY|||||||0.299|||||||Wilcoxon (Mann-Whitney)|||||||0.299
72610279|NCT03363906|144749384|SUPERIORITY||Ratio Geometric Least Squares (LS) Mean|1.04||||0.473|TWO_SIDED|90.0|0.949|1.14|||Mixed Models Analysis|||||1.14|0.949|0.473
72610280|NCT03363906|144749385|SUPERIORITY||Mean Difference (Final Values)|1.14||||0.119|TWO_SIDED|90.0|0.993|1.3|||ANOVA|||||1.30|0.993|0.119
72610281|NCT02330341|144749401|SUPERIORITY|||||||0.38||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of postprandial glucose on Artemisia Dracunculus group||||0.380
72610282|NCT02330341|144749401|SUPERIORITY|||||||0.695|||||||Wilcoxon (Mann-Whitney)|The threshold for statistical significance was p=0.05||Results showed in this section are the result of the differences between baseline and final values of postprandial glucose on placebo group||||0.695
72610283|NCT02330341|144749402|SUPERIORITY|||||||0.11||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of fasting glucose on Artemisia Dracunculus group||||0.110
72610284|NCT02330341|144749402|SUPERIORITY|||||||0.91||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of fasting glucose on placebo group||||0.910
72610285|NCT02330341|144749403|SUPERIORITY|||||||0.01||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of glucosylated hemoglobin on Artemisia Dracunculus group||||0.010
72610286|NCT02330341|144749403|SUPERIORITY|||||||0.938||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of glucosylated hemoglobin on placebo group||||0.938
72610287|NCT02330341|144749404|SUPERIORITY|||||||0.733||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of first phase of insulin secretion on Artemisia Dracunculus group||||0.733
72610288|NCT02330341|144749404|SUPERIORITY|||||||1||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of first phase of insulin secretion on placebo group||||1.0
72610289|NCT02330341|144749405|SUPERIORITY|||||||0.03||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of total insulin secretion on Artemisia Dracunculus group||||0.03
72610290|NCT02330341|144749405|SUPERIORITY|||||||0.9||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of total insulin secretion on placebo group||||0.900
72610291|NCT02330341|144749406|SUPERIORITY|||||||0.519||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of insulin sensitivity on Artemisia Dracunculus group||||0.519
72610292|NCT02330341|144749406|SUPERIORITY|||||||0.922||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of insulin sensitivity on placebo group||||0.922
72610293|NCT02330341|144749407|SUPERIORITY|||||||0.605||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of weight on Artemisia Dracunculus group||||0.605
72610294|NCT02330341|144749407|SUPERIORITY|||||||0.105||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of weight on placebo group||||0.105
72610295|NCT02330341|144749408|SUPERIORITY|||||||0.687||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of BMI on Artemisia Dracunculus group||||0.687
72610296|NCT02330341|144749408|SUPERIORITY|||||||0.021||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of BMI on placebo group||||0.021
72610297|NCT02330341|144749409|SUPERIORITY|||||||0.339||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of total cholesterol on Artemisia Dracunculus group||||0.339
72610298|NCT02330341|144749409|SUPERIORITY|||||||0.246||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of total cholesterol on placebo group||||0.246
72610299|NCT02330341|144749410|SUPERIORITY|||||||0.775||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of triglycerides on Artemisia Dracunculus group||||0.775
72610300|NCT02330341|144749410|SUPERIORITY|||||||0.195||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of triglycerides on placebo group||||0.195
72610301|NCT02330341|144749411|SUPERIORITY|||||||0.04||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of HDL-c on Artemisia Dracunculus group||||0.040
72610302|NCT02330341|144749411|SUPERIORITY|||||||1||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of HDL-c on placebo group||||1.000
72610303|NCT02330341|144749412|SUPERIORITY|||||||0.021||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of ALT on Artemisia Dracunculus group||||0.021
72610304|NCT02330341|144749412|SUPERIORITY|||||||0.08||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of ALT on placebo group||||0.080
72610305|NCT02330341|144749413|SUPERIORITY|||||||0.465||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of AST on Artemisia Dracunculus group||||0.465
72610306|NCT02330341|144749413|SUPERIORITY|||||||0.574||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of AST on placebo group||||0.574
72610307|NCT02330341|144749414|SUPERIORITY|||||||0.48||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of creatinine on Artemisia Dracunculus group||||0.480
72610308|NCT02330341|144749414|SUPERIORITY|||||||0.383||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of creatinine on placebo group||||0.383
72326191|NCT02722408|144175859|OTHER|||||||0.0007||||||Mixed-effects model for repeated measures analysis: Change in LDL-C as dependent variable, visit as fixed effect, patient as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84 (Not Met EAS Clinical Diagnosis of HoFH)||||0.0007
72610309|NCT02330341|144749415|SUPERIORITY|||||||0.034||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of uric acid on Artemisia Dracunculus group||||0.034
72610310|NCT02330341|144749415|SUPERIORITY|||||||0.08||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of uric acid on placebo group||||0.080
72610311|NCT02330341|144749416|SUPERIORITY|||||||0.017||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of systolic blood pressure on Artemisia Dracunculus group||||0.017
72610312|NCT02330341|144749416|SUPERIORITY|||||||0.082||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of systolic blood pressure on placebo group||||0.082
72610313|NCT02330341|144749417|SUPERIORITY|||||||0.17||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of diastolic blood pressure on Artemisia Dracunculus group||||0.170
72610314|NCT02330341|144749417|SUPERIORITY|||||||0.199||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of diastolic blood pressure placebo group||||0.199
72610315|NCT00997893|144749474|OTHER|||||||0.004||||||treatment x time p=.004|Mixed Models Analysis||||A mixed effects regression model (Estimation method=maximum likelihood; Random intercept) was conducted to compare the effects of phytoestrogens and estradiol to placebo. Primary predictor variables in the model included treatment and time, as well the treatment by time interaction.|||.004
72610316|NCT00997893|144749475|OTHER|||||||0.98||||||visit x time x treatment interaction p=.98|Mixed Models Analysis||||A mixed effects regression model (Estimation method=maximum likelihood; Random intercept) was conducted to compare the effects of phytoestrogens and estradiol to placebo before and after a psychosocial stressor. Predictor variables in the model included treatment, time (before and after the psychosocial stressor), visit (Baseline, 12 weeks), and all two and three way interactions.|||.98
72610317|NCT00997893|144749476|OTHER|||||||0.68||||||treatment x time (before and after the psychosocial stressor) x visit p=.68|Mixed Models Analysis||||A mixed effects regression model (Estimation method=maximum likelihood; Random intercept) was conducted to compare the effects of phytoestrogens and estradiol to placebo on emotional memory following a laboratory induced stress. Primary predictor variables in the model included treatment, time (before and after the psychosocial stressor), visit (Baseline, 12 weeks), and all two and three way interactions.|||.68
72610318|NCT00997893|144749477|OTHER|||||||0.11||||||treatment x time p=.11|Mixed Models Analysis||||A mixed effects regression model (Estimation method=maximum likelihood; Random intercept) was conducted to compare the effects of phytoestrogens and estradiol to placebo on verbal memory (logical memory; immediate). Primary predictor variables in the model included treatment and time, as well the treatment by time interaction.|||.11
72610319|NCT00997893|144749478|OTHER|||||||0.86||||||treatment x time p=.86|Mixed Models Analysis||||A mixed effects regression model (Estimation method=maximum likelihood; Random intercept) was conducted to compare the effects of phytoestrogens and estradiol to placebo on verbal memory (logical memory; immediate)Primary predictor variables in the model included treatment and time, as well the treatment by time interaction.|||.86
72610320|NCT01258049|144749495|SUPERIORITY_OR_OTHER||Percentage Difference|54.85|||<|0.005|TWO_SIDED|95.0|42.25|67.45|||Regression, Logistic|||In ART003, the parasite success rate for quinine was 67.7%. On the assumption that the parasite success rate was 70% for quinine in this study and in order to demonstrate that ArTiMist™ is superior to quinine by at least 20% the success rate for ArTiMist™ should be at least 90%. Using these figures, and assuming a power of 80%, an alpha of 0.05 (two sided) and based on an equal allocation to the ArTiMist™ and quinine treatment arms, the number of subjects (n) required on each treatment was 59.||67.45|42.25|<0.005
72610321|NCT01258049|144749496|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-38.97|||<|0.05|TWO_SIDED|95.0|-62.22|-15.72|||ANCOVA|||||-15.72|-62.22|<0.05
72610322|NCT01258049|144749497|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.91|||<|0.005|TWO_SIDED|95.0|-17.38|-8.44|||ANCOVA|||||-8.44|-17.38|<0.005
72610323|NCT01258049|144749498|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.16|||<|0.005|TWO_SIDED|95.0|-11.71||||Regression, Cox|||||- 6.61|-11.71|<0.005
72610324|NCT01258049|144749499|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|54.02|||<|0.005|TWO_SIDED|95.0|27.05|80.98|||ANCOVA|||||80.98|27.05|<0.005
72610325|NCT01258049|144749500|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|174.09||||0.06|TWO_SIDED|95.0|-10.44|358.61|||ANCOVA||mean parasite counts increased in the first 12 hours for patients on quinine treatment|||358.61|-10.44|0.06
72610326|NCT01258049|144749501|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.96||||0.86|TWO_SIDED|95.0|-10.16|12.08|||Regression, Cox|||||12.08|-10.16|0.86
72610327|NCT01258049|144749502|SUPERIORITY_OR_OTHER||Percentage Difference|0.99||||0.99|TWO_SIDED|95.0|0.42|2.36|||Regression, Logistic|||||2.36|0.42|0.99
72610328|NCT01258049|144749505|SUPERIORITY_OR_OTHER||Percentage Difference|55.01|||<|0.005|TWO_SIDED|95.0|42.44|67.58|||Regression, Linear|||||67.58|42.44|<0.005
72610329|NCT03444584|144749532|SUPERIORITY||LS mean difference|-143.09|||<|0.0001|TWO_SIDED|95.0|-198.2|-87.98|||ANCOVA|||||-87.98|-198.20|<0.0001
72610330|NCT03444584|144749533|SUPERIORITY||LS mean difference|-22.17|||<|0.0001|TWO_SIDED|95.0|-30.24|-14.1|||ANCOVA|||||-14.10|-30.24|<0.0001
72610331|NCT01142336|144749561|SUPERIORITY|||||||0.53||||||Threshold for significance: 0.05, adjust for 3 primary outcomes using Holm Correction|ANCOVA|Response variable was Aβ42 in CSF at 1 year, and predictor variables were Aβ42 in CSF at baseline, treatment group, age, sex, and APOE e4 allele.||||||0.53
72610332|NCT01142336|144749562|SUPERIORITY|||||||0.36||||||Threshold for significance: 0.05, adjusted for 3 primary outcomes using Holm correction|ANCOVA|Response variable was total tau in CSF at 1 year, and predictor were total tau in at baseline, treatment group, age, sex, and APOE e4 allele status||||||0.36
72610333|NCT01142336|144749563|SUPERIORITY|||||||0.25||||||Threshold for significance: 0.05, adjusted for 3 primary outcomes using Holm correction.|ANCOVA|Response variable was p-tau181 in CSF at 1 year, and predictor were p-tau181 in at baseline, treatment group, age, sex, and APOE e4 allele status||||||0.25
72610334|NCT03704064|144749564|SUPERIORITY||Mean Difference (Net)|-1.97|STANDARD_ERROR_OF_MEAN|1.32||0.14|TWO_SIDED||||||Mixed Models Analysis|||||||0.14
72610335|NCT03704064|144749565|SUPERIORITY||Odds Ratio (OR)|1.1||||0.89|TWO_SIDED|95.0|0.4|3.4|||Mixed Models Analysis|||||3.4|0.4|0.89
72610336|NCT03704064|144749566|SUPERIORITY||Odds Ratio (OR)|3.7||||0.06|TWO_SIDED|95.0|1.0|14.7|||Mixed Models Analysis|||||14.7|1.0|0.06
72610337|NCT03704064|144749567|SUPERIORITY||Mean Difference (Net)|-2.4|STANDARD_ERROR_OF_MEAN|1.3||0.07|TWO_SIDED||||||Mixed Models Analysis|||||||0.07
72610338|NCT03704064|144749568|SUPERIORITY||Mean Difference (Net)|-1.1|STANDARD_ERROR_OF_MEAN|1.3||0.42|TWO_SIDED||||||Mixed Models Analysis|||||||0.42
72610339|NCT03704064|144749569|SUPERIORITY||Odds Ratio (OR)|2.0||||0.24|TWO_SIDED|95.0|0.6|6.3|||Mixed Models Analysis|||||6.3|0.6|0.24
72610340|NCT03704064|144749570|SUPERIORITY||Odds Ratio (OR)|2.2||||0.24|TWO_SIDED|95.0|0.6|8.1|||Mixed Models Analysis|||||8.1|0.6|0.24
72610341|NCT03704064|144749571|SUPERIORITY||Odds Ratio (OR)|3.0||||0.07|TWO_SIDED|95.0|0.9|9.6|||Mixed Models Analysis|||||9.6|0.9|0.07
72610342|NCT03704064|144749572|SUPERIORITY||Odds Ratio (OR)|2.6||||0.21|TWO_SIDED|95.0|0.6|11.4|||Mixed Models Analysis|||||11.4|0.6|0.21
72610343|NCT03704064|144749573|SUPERIORITY||Mean Difference (Net)|2.4|STANDARD_ERROR_OF_MEAN|5.8||0.62|TWO_SIDED||||||Mixed Models Analysis|||MVPA per day with 10 minute bouts||||0.62
72610344|NCT03704064|144749573|SUPERIORITY||Mean Difference (Net)|1.0|STANDARD_ERROR_OF_MEAN|4.5||0.92|TWO_SIDED||||||Mixed Models Analysis|||MVPA per day with 20 minute bouts||||0.92
72610345|NCT03704064|144749573|SUPERIORITY||Mean Difference (Net)|13.4|STANDARD_ERROR_OF_MEAN|9.6||0.16|TWO_SIDED||||||Mixed Models Analysis|||Moderate activity per day||||0.16
72610346|NCT03704064|144749573|SUPERIORITY||Mean Difference (Net)|15.9|STANDARD_ERROR_OF_MEAN|20.8||0.41|TWO_SIDED||||||Mixed Models Analysis|||Light activity per day||||0.41
72610347|NCT03704064|144749574|SUPERIORITY||Mean Difference (Net)|4.1|STANDARD_ERROR_OF_MEAN|6.1||0.46|TWO_SIDED||||||Mixed Models Analysis|||MVPA per day with 10 minute bouts||||0.46
72610348|NCT03704064|144749574|SUPERIORITY||Mean Difference (Net)|-0.5|STANDARD_ERROR_OF_MEAN|4.9||0.87|TWO_SIDED||||||Mixed Models Analysis|||MVPA per day with 20 minute bouts||||0.87
72610349|NCT03704064|144749574|SUPERIORITY||Mean Difference (Net)|18.5|STANDARD_ERROR_OF_MEAN|10.1||0.07|TWO_SIDED||||||Mixed Models Analysis|||Moderate activity per day||||0.07
72610350|NCT03704064|144749574|SUPERIORITY||Mean Difference (Net)|30.0|STANDARD_ERROR_OF_MEAN|22.5||0.17|TWO_SIDED||||||Mixed Models Analysis|||Light activity per day||||0.17
72610351|NCT03704064|144749575|SUPERIORITY||Mean Difference (Net)|2.2|STANDARD_ERROR_OF_MEAN|5.7||0.63|TWO_SIDED||||||Mixed Models Analysis|||MVPA per day with 10 minute bouts||||0.63
72610352|NCT03704064|144749575|SUPERIORITY||Mean Difference (Net)|0.6|STANDARD_ERROR_OF_MEAN|3.7||0.72|TWO_SIDED||||||Mixed Models Analysis|||MVPA per day with 20 minute bouts||||0.72
72610353|NCT03704064|144749575|SUPERIORITY||Mean Difference (Net)|6.0|STANDARD_ERROR_OF_MEAN|9.4||0.52|TWO_SIDED||||||Mixed Models Analysis|||Moderate activity per day||||0.52
72610354|NCT03704064|144749575|SUPERIORITY||Mean Difference (Net)|-21.8|STANDARD_ERROR_OF_MEAN|19.4||0.27|TWO_SIDED||||||Mixed Models Analysis|||Light activity per day||||0.27
72610355|NCT03704064|144749576|SUPERIORITY||Mean Difference (Net)|7.3|STANDARD_ERROR_OF_MEAN|151.2||0.84|TWO_SIDED||||||Mixed Models Analysis|||||||0.84
72610356|NCT03704064|144749577|SUPERIORITY||Mean Difference (Net)|-111.7|STANDARD_ERROR_OF_MEAN|137.2||0.53|TWO_SIDED||||||Mixed Models Analysis|||||||0.53
72418168|NCT03318523|144346604|SUPERIORITY|Adjusted mean, difference with delayed start group, 95% CI, and p-value were based on an MMRM model, with change from baseline in MDS-UPDRS score as dependent variable and with fixed effects of treatment group, time, treatment group-by-time interaction, region, PD subtype, prior use of PD medication, corresponding baseline MDS-UPDRS score, corresponding baseline MDS-UPDRS by time interaction, baseline striatum SBR values and baseline striatum SBR value by time interaction.|Difference|-0.1||||0.9506|TWO_SIDED|95.0|-3.192|2.997|||Mixed Model for Repeated Measures|||Change from Baseline in MDS-UPDRS Subpart III Score at Week 96||2.997|-3.192|0.9506
72418169|NCT03318523|144346604|SUPERIORITY|Adjusted mean, difference with delayed start group, 95% CI, and p-value were based on an MMRM model, with change from baseline in MDS-UPDRS score as dependent variable and with fixed effects of treatment group, time, treatment group-by-time interaction, region, PD subtype, prior use of PD medication, corresponding baseline MDS-UPDRS score, corresponding baseline MDS-UPDRS by time interaction, baseline striatum SBR values and baseline striatum SBR value by time interaction.|Difference|0.69||||0.6643|TWO_SIDED|95.0|-2.422|3.794|||Mixed Model for Repeated Measures|||Change from Baseline in MDS-UPDRS Subpart III Score at Week 96||3.794|-2.422|0.6643
72610357|NCT03704064|144749578|SUPERIORITY||Mean Difference (Net)|163.2|STANDARD_ERROR_OF_MEAN|154.0||0.27|TWO_SIDED||||||Mixed Models Analysis|||||||0.27
72610358|NCT03704064|144749579|SUPERIORITY||Mean Difference (Net)|5.7|STANDARD_ERROR_OF_MEAN|4.6||0.22|TWO_SIDED||||||Mixed Models Analysis|||||||0.22
72610359|NCT03704064|144749580|SUPERIORITY||Mean Difference (Net)|5.3|STANDARD_ERROR_OF_MEAN|4.6||0.24|TWO_SIDED||||||Mixed Models Analysis|||||||0.24
72610360|NCT03704064|144749581|SUPERIORITY||Mean Difference (Net)|3.2|STANDARD_ERROR_OF_MEAN|4.5||0.48|TWO_SIDED||||||Mixed Models Analysis|||||||0.48
72610361|NCT03704064|144749582|SUPERIORITY||Mean Difference (Net)|4.9|STANDARD_ERROR_OF_MEAN|3.4||0.16|TWO_SIDED||||||Mixed Models Analysis|||||||0.16
72610362|NCT03704064|144749583|SUPERIORITY||Mean Difference (Net)|6.8|STANDARD_ERROR_OF_MEAN|3.4||0.045|TWO_SIDED||||||Mixed Models Analysis|||||||0.045
72610363|NCT03704064|144749584|SUPERIORITY||Mean Difference (Net)|3.7|STANDARD_ERROR_OF_MEAN|3.4||0.27|TWO_SIDED||||||Mixed Models Analysis|||||||0.27
72610364|NCT03704064|144749585|SUPERIORITY||Mean Difference (Net)|3.9|STANDARD_ERROR_OF_MEAN|9.4||0.72|TWO_SIDED||||||Mixed Models Analysis|||||||0.72
72610365|NCT03704064|144749586|SUPERIORITY||Mean Difference (Net)|-3.3|STANDARD_ERROR_OF_MEAN|9.1||0.67|TWO_SIDED||||||Mixed Models Analysis|||||||0.67
72610366|NCT03704064|144749587|SUPERIORITY||Mean Difference (Net)|0.6|STANDARD_ERROR_OF_MEAN|2.5||0.8|TWO_SIDED||||||Mixed Models Analysis|||Systolic Blood Pressure||||0.80
72610367|NCT03704064|144749587|SUPERIORITY||Mean Difference (Net)|0.1|STANDARD_ERROR_OF_MEAN|1.1||0.94|TWO_SIDED||||||Mixed Models Analysis|||Diastolic Blood Pressure||||0.94
72610368|NCT03704064|144749588|SUPERIORITY||Mean Difference (Net)|-4.3|STANDARD_ERROR_OF_MEAN|2.3||0.07|TWO_SIDED||||||Mixed Models Analysis|||Systolic Blood Pressure||||0.07
72610369|NCT03704064|144749588|SUPERIORITY||Mean Difference (Net)|0.1|STANDARD_ERROR_OF_MEAN|1.5||0.96|TWO_SIDED||||||Mixed Models Analysis|||Diastolic Blood Pressure||||0.96
72610370|NCT03704064|144749589|SUPERIORITY||Mean Difference (Net)|-0.2|STANDARD_ERROR_OF_MEAN|0.2||0.3|TWO_SIDED||||||Mixed Models Analysis|||||||0.30
72610371|NCT03704064|144749590|SUPERIORITY||Mean Difference (Net)|-0.1|STANDARD_ERROR_OF_MEAN|0.2||0.67|TWO_SIDED||||||Mixed Models Analysis|||||||0.67
72610372|NCT03704064|144749591|SUPERIORITY||Mean Difference (Net)|-0.2|STANDARD_ERROR_OF_MEAN|0.2||0.45|TWO_SIDED||||||Mixed Models Analysis|||||||0.45
72610373|NCT03704064|144749592|SUPERIORITY||Odds Ratio (OR)|1.7||||0.38|TWO_SIDED|95.0|0.5|5.9|||Mixed Models Analysis|||||5.9|0.5|0.38
72610374|NCT03704064|144749593|SUPERIORITY||Odds Ratio (OR)|1.0||||0.95|TWO_SIDED|95.0|0.3|3.3|||Mixed Models Analysis|||||3.3|0.3|0.95
72610375|NCT03704064|144749594|SUPERIORITY||Odds Ratio (OR)|1.0||||0.99|TWO_SIDED|95.0|0.3|3.1|||Mixed Models Analysis|||||3.1|0.3|0.99
72610376|NCT03704064|144749595|SUPERIORITY||Mean Difference (Net)|-3.0|STANDARD_ERROR_OF_MEAN|1.6||0.06|TWO_SIDED||||||Mixed Models Analysis|||WSSQ-Total||||0.06
72610377|NCT03704064|144749595|SUPERIORITY||Mean Difference (Net)|-1.8|STANDARD_ERROR_OF_MEAN|0.9||0.06|TWO_SIDED||||||Mixed Models Analysis|||WSSQ-SD||||0.06
72610378|NCT03704064|144749595|SUPERIORITY||Mean Difference (Net)|-1.2|STANDARD_ERROR_OF_MEAN|0.9||0.19|TWO_SIDED||||||Mixed Models Analysis|||WSSQ-FE||||0.19
72610379|NCT03704064|144749596|SUPERIORITY||Mean Difference (Net)|-3.0|STANDARD_ERROR_OF_MEAN|1.5||0.05|TWO_SIDED||||||Mixed Models Analysis|||WSSQ-Total||||0.05
72610380|NCT03704064|144749596|SUPERIORITY||Mean Difference (Net)|-1.2|STANDARD_ERROR_OF_MEAN|0.9||0.18|TWO_SIDED||||||Mixed Models Analysis|||WSSQ-SD||||0.18
72610381|NCT03704064|144749596|SUPERIORITY||Mean Difference (Net)|-1.8|STANDARD_ERROR_OF_MEAN|0.9||0.046|TWO_SIDED||||||Mixed Models Analysis|||WSSQ-FE||||0.046
72610382|NCT03704064|144749597|SUPERIORITY||Mean Difference (Net)|-2.7|STANDARD_ERROR_OF_MEAN|1.5||0.07|TWO_SIDED||||||Mixed Models Analysis|||WSSQ-Total||||0.07
72610383|NCT03704064|144749597|SUPERIORITY||Mean Difference (Net)|-1.5|STANDARD_ERROR_OF_MEAN|0.9||0.11|TWO_SIDED||||||Mixed Models Analysis|||WSSQ-SD||||0.11
72610384|NCT03704064|144749597|SUPERIORITY||Mean Difference (Net)|-1.3|STANDARD_ERROR_OF_MEAN|0.9||0.15|TWO_SIDED||||||Mixed Models Analysis|||WSSQ-FE||||0.15
72610385|NCT03704064|144749598|SUPERIORITY||Mean Difference (Net)|0.6|STANDARD_ERROR_OF_MEAN|0.3||0.04|TWO_SIDED||||||ANOVA|||Overall treatment acceptability||||0.04
72610386|NCT03704064|144749598|SUPERIORITY||Mean Difference (Net)|0.3|STANDARD_ERROR_OF_MEAN|0.3||0.35|TWO_SIDED||||||ANOVA|||BWL component acceptability||||0.35
72610387|NCT03704064|144749598|SUPERIORITY||Mean Difference (Net)|1.5|STANDARD_ERROR_OF_MEAN|0.3|<|0.001|TWO_SIDED||||||ANOVA|||BIAS vs recipe component acceptability||||<0.001
72610388|NCT03704064|144749598|SUPERIORITY||Mean Difference (Net)|0.6|STANDARD_ERROR_OF_MEAN|0.2||0.01|TWO_SIDED||||||ANOVA|||BWL skill acquisition||||0.01
72610389|NCT03704064|144749598|SUPERIORITY||Mean Difference (Net)|1.0|STANDARD_ERROR_OF_MEAN|0.3|<|0.001|TWO_SIDED||||||ANOVA|||Stigma-related skill acquisition||||<0.001
72610390|NCT03704064|144749598|SUPERIORITY||Mean Difference (Net)|0.7|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED||||||ANOVA|||Stigma-related skill use||||<0.001
72610391|NCT03704064|144749599|SUPERIORITY||Mean Difference (Net)|0.3|STANDARD_ERROR_OF_MEAN|0.3||0.24|TWO_SIDED||||||ANOVA|||Overall treatment acceptability||||0.24
72610392|NCT03704064|144749599|SUPERIORITY||Mean Difference (Net)|0.3|STANDARD_ERROR_OF_MEAN|0.3||0.28|TWO_SIDED||||||ANOVA|||BWL component acceptability||||0.28
72418170|NCT03318523|144346605|SUPERIORITY|Adjusted mean, difference with placebo, 95% CI, and p-value were based on an MMRM model, with change from baseline in DaT/SPECT parameter as dependent variable and with fixed effects of treatment group, region, time, treatment group-by-time interaction, baseline MDS-UPDRS part I+II+III total score, baseline MDS-UPDRS part I+II+III total score by time interaction, baseline DaT/SPECT values and baseline DaT/SPECT by time interaction.|Difference|-0.005||||0.8274|TWO_SIDED|95.0|-0.0548|0.0438|||Mixed Model for Repeated Measures|||||0.0438|-0.0548|0.8274
72418171|NCT03318523|144346605|SUPERIORITY|Adjusted mean, difference with placebo, 95% CI, and p-value were based on an MMRM model, with change from baseline in DaT/SPECT parameter as dependent variable and with fixed effects of treatment group, region, time, treatment group-by-time interaction, baseline MDS-UPDRS part I+II+III total score, baseline MDS-UPDRS part I+II+III total score by time interaction, baseline DaT/SPECT values and baseline DaT/SPECT by time interaction.|Difference|-0.009||||0.6671|TWO_SIDED|95.0|-0.0504|0.0323|||Mixed Model for Repeated Measures|||||0.0323|-0.0504|0.6671
72418172|NCT03318523|144346605|SUPERIORITY|Adjusted mean, difference with placebo, 95% CI, and p-value were based on an MMRM model, with change from baseline in DaT/SPECT parameter as dependent variable and with fixed effects of treatment group, region, time, treatment group-by-time interaction, baseline MDS-UPDRS part I+II+III total score, baseline MDS-UPDRS part I+II+III total score by time interaction, baseline DaT/SPECT values and baseline DaT/SPECT by time interaction.|Difference|-0.033||||0.1313|TWO_SIDED|95.0|-0.0751|0.0098|||Mixed Model for Repeated Measures|||||0.0098|-0.0751|0.1313
72610393|NCT03704064|144749599|SUPERIORITY||Mean Difference (Net)|1.8|STANDARD_ERROR_OF_MEAN|0.4|<|0.001|TWO_SIDED||||||ANOVA|||BIAS vs recipe component acceptability||||<0.001
72610394|NCT03704064|144749599|SUPERIORITY||Mean Difference (Net)|0.3|STANDARD_ERROR_OF_MEAN|0.3||0.34|TWO_SIDED||||||ANOVA|||BWL skill acquisition||||0.34
72610395|NCT03704064|144749599|SUPERIORITY||Mean Difference (Net)|0.8|STANDARD_ERROR_OF_MEAN|0.3||0.008|TWO_SIDED||||||ANOVA|||Stigma-related skill acquisition||||0.008
72610396|NCT03704064|144749599|SUPERIORITY||Mean Difference (Net)|0.6|STANDARD_ERROR_OF_MEAN|0.2||0.001|TWO_SIDED||||||ANOVA|||Stigma-related skill use||||0.001
72610397|NCT02783911|144749640|SUPERIORITY|||||||0.808|||||||Chi-squared|||||||0.808
72610398|NCT00071981|144749641|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|95.0|||||Fisher Exact|||Compare CTL response rate among four arms. The null hypothesis is that CTL response is same in all four arms. Alternative hypothesis is that CTL response rate is different in at least one arm compared to other arms.||||<0.001
72610399|NCT00071981|144749642|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|95.0|||||Fisher Exact|||Compare HTL response rate to 6MHP among four arms. The null hypothesis is that HTL response is same in all four arms. Alternative hypothesis is that HTL response rate is different in at least one arm compared to other arms.||||<0.001
72610400|NCT00071981|144749643|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|95.0|||||Fisher Exact|||Compare HTL response rate to tetanus peptide among four arms. The null hypothesis is that HTL response is same in all four arms. Alternative hypothesis is that HTL response rate is different in at least one arm compared to other arms.||||<0.001
72610401|NCT00071981|144749644|SUPERIORITY_OR_OTHER_LEGACY|||||||0.741|TWO_SIDED|95.0|||||Fisher Exact|||Compare objective response rate among four arms. The null hypothesis is that objective response rate is same in all four arms. Alternative hypothesis is that objective response rate is different in at least one arm compared to other arms.||||0.741
72610402|NCT00071981|144749645|SUPERIORITY_OR_OTHER_LEGACY|||||||0.532|TWO_SIDED|95.0|||||Log Rank|||Compare overall survival curves among four arms.||||0.532
72610403|NCT01123655|144749646|EQUIVALENCE|P less than 0.05 was the criteria for equivalence.||||||0.5179|||||||Fisher Exact|||Specified to be a reduction from baseline values of net IFNƔ concentration of ≥ 25% in αl(ll)-stimulated PBMC culture supernatants (calculated as αI(II)-IFNƔ-PBS IFNƔ in patients receiving APL A12 compared to placebo.||||0.5179
72610404|NCT01123655|144749646|EQUIVALENCE|Null hypothesis was that the response rate in the APL treated groups is not significantly difference from the 50% spontaneous response rate.||||||0.0114|||||||Exact Test|||||||0.0114
72610405|NCT01123655|144749646|EQUIVALENCE|Null hypothesis was that the response rate in the placebo group is not significantly difference from the 50% spontaneous response rate.||||||0.4142|||||||Exact Test|||||||0.4142
72610406|NCT01123655|144749648|EQUIVALENCE|P greater than 0.05 was the criteria for equivalence.|||||>|0.05||||||P value is applicable for baseline and follow-up data.|Mixed Models Analysis|||||||>0.05
72610407|NCT01123655|144749649|EQUIVALENCE|p value greater than 0.05 was the criteria for equivalence.|||||>|0.05||||||P value is applicable to IL-17a, IL-10, IL-1b, IL-9, IL-13, IL-5, IL-21, IL-6, TNFa, TGFb, MIP3a.|t-test, 2 sided|||||||>0.05
72610408|NCT01041859|144749688|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.95|STANDARD_ERROR_OF_MEAN|0.234|<|0.001|TWO_SIDED|95.0|-1.415|-0.493||Analysis of covariance (ANCOVA) model was used with treatment, dose level, and pooled analysis center as factors and baseline pain intensity score as a covariate|ANCOVA||Mean Difference is least squares mean change in DB Tapentadol ER group minus least squares mean change in DB Placebo group (based on ANCOVA model)|The primary null hypothesis to be tested for the study was that the tapentadol ER group was not different from the placebo group for the primary endpoint. Assuming the mean treatment group difference of 1.0 with an SD of 2.6, 144 subjects per treatment group were estimated to provide 90% power to show that the tapentadol ER group was statistically different from placebo at an alpha level of 0.05. The total number of subjects to be randomly assigned to a DB treatment group for the study was 300.||-0.493|-1.415|<0.001
72610409|NCT02908347|144749712|SUPERIORITY||Median Difference (Final Values)|0.64||||0.8785|TWO_SIDED|95.0|-2.09|3.36|||Wilcoxon (Mann-Whitney)|||||3.36|-2.09|0.8785
72610410|NCT02908347|144749715|SUPERIORITY|||||||1|||||||Fisher Exact|||PASI 30 - Day 29||||1
72610411|NCT02908347|144749715|SUPERIORITY|||||||1|||||||Fisher Exact|||PASI 50 - Day 29||||1
72326192|NCT02722408|144175860|OTHER|||||||0.388||||||Mixed-effects model for repeated measures analysis with percent change in Non-HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28 (Negative LDLr)||||0.3880
72610412|NCT02908347|144749715|SUPERIORITY|||||||0.5136|||||||Fisher Exact|||PASI 30 - Day 43||||0.5136
72610413|NCT02908347|144749715|SUPERIORITY|||||||1|||||||Fisher Exact|||PASI 50 - Day 43||||1
72610414|NCT00885118|144749723|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|42828.482|STANDARD_ERROR_OF_MEAN|6487.174|<|0.0001|TWO_SIDED|95.0|29936.586|55720.378|||ANCOVA|The baseline value was included as a continuous covariate.||Difference calculated as empa 1mg minus placebo||55720.378|29936.586|<0.0001
72610415|NCT00885118|144749723|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|80964.677|STANDARD_ERROR_OF_MEAN|6303.82|<|0.0001|TWO_SIDED|95.0|68437.16|93492.194|||ANCOVA|The baseline value was included as a continuous covariate||Difference calculated as empa 5mg minus placebo||93492.194|68437.160|<0.0001
72610416|NCT00885118|144749723|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|88589.764|STANDARD_ERROR_OF_MEAN|6544.604|<|0.0001|TWO_SIDED|95.0|75583.738|101595.79|||ANCOVA|The baseline value was included as a continuous covariate||Difference calculated as empa 10mg minus placebo||101595.790|75583.738|<0.0001
72610417|NCT00885118|144749723|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|85620.348|STANDARD_ERROR_OF_MEAN|6610.091|<|0.0001|TWO_SIDED|95.0|72484.181|98756.515|||ANCOVA|The baseline value was included as a continuous covariate||Difference calculated as empa 25mg minus placebo||98756.515|72484.181|<0.0001
72610418|NCT00885118|144749724|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.68|STANDARD_ERROR_OF_MEAN|4.155||0.003|TWO_SIDED|95.0|-20.936|-4.424|||ANCOVA|The baseline value was included as a continuous covariate||Difference calculated as empa 1mg minus placebo||-4.424|-20.936|0.0030
72610419|NCT00885118|144749724|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.92|STANDARD_ERROR_OF_MEAN|4.025|<|0.0001|TWO_SIDED|95.0|-27.919|-11.921|||ANCOVA|The baseline value was included as a continuous covariate||Difference calculated as empa 5mg minus placebo||-11.921|-27.919|<0.0001
72610420|NCT00885118|144749724|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-26.208|STANDARD_ERROR_OF_MEAN|4.168|<|0.0001|TWO_SIDED|95.0|-34.49|-17.925|||ANCOVA|The baseline value was included as a continuous covariate||Difference calculated as empa 10mg minus placebo||-17.925|-34.490|<0.0001
72610421|NCT00885118|144749724|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-27.235|STANDARD_ERROR_OF_MEAN|4.202|<|0.0001|TWO_SIDED|95.0|-35.586|-18.884|||ANCOVA|The baseline value was included as a continuous covariate||Difference calculated as empa 25mg minus placebo||-18.884|-35.586|<0.0001
72610422|NCT00885118|144749725|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.883|STANDARD_ERROR_OF_MEAN|5.861||0.003|TWO_SIDED|95.0|-29.529|-6.236|||ANCOVA|The baseline value was included as a continuous covariate||Difference calculated as empa 1mg minus placebo||-6.236|-29.529|0.0030
72610423|NCT00885118|144749725|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-22.487|STANDARD_ERROR_OF_MEAN|5.445|<|0.0001|TWO_SIDED|95.0|-33.308|-11.665|||ANCOVA|The baseline value was included as a continuous covariate||Difference calculated as empa 5mg minus placebo||-11.665|-33.308|<0.0001
72610424|NCT00885118|144749725|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-26.265|STANDARD_ERROR_OF_MEAN|5.785|<|0.0001|TWO_SIDED|95.0|-37.762|-14.768|||ANCOVA|The baseline value was included as a continuous covariate||Difference calculated as empa 10mg minus placebo||-14.768|-37.762|<0.0001
72610425|NCT00885118|144749725|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-28.34|STANDARD_ERROR_OF_MEAN|5.699|<|0.0001|TWO_SIDED|95.0|-39.665|-17.015|||ANCOVA|The baseline value was included as a continuous covariate||Difference calculated as empa 25mg minus placebo||-17.015|-39.665|<0.0001
72610426|NCT00885118|144749726|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.239|STANDARD_ERROR_OF_MEAN|0.13||0.0705|TWO_SIDED|95.0|-0.498|-0.02|||ANCOVA|The baseline value was included as a continuous covariate||Difference calculated as empa 1mg minus placebo||-0.020|-0.498|0.0705
72610427|NCT00885118|144749726|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.296|STANDARD_ERROR_OF_MEAN|0.125||0.0203|TWO_SIDED|95.0|-0.545|-0.047|||ANCOVA|The baseline value was included as a continuous covariate||Difference calculated as empa 5mg minus placebo||-0.047|-0.545|0.0203
72610428|NCT00885118|144749726|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.429|STANDARD_ERROR_OF_MEAN|0.13||0.0014|TWO_SIDED|95.0|-0.687|-0.17|||ANCOVA|The baseline value was included as a continuous covariate||Difference calculated as empa 10mg minus placebo||-0.170|-0.687|0.0014
72326193|NCT02722408|144175860|OTHER|||||||0.2057||||||Mixed-effects model for repeated measures analysis with percent change in Non-HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56 (Negative LDLr)||||0.2057
72610429|NCT00885118|144749726|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.395|STANDARD_ERROR_OF_MEAN|0.131||0.0033|TWO_SIDED|95.0|-0.654|-0.135|||ANCOVA|The baseline value was included as a continuous covariate||Difference calculated as empa 25mg minus placebo||-0.135|-0.654|0.0033
72610430|NCT00885118|144749727|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.527|STANDARD_ERROR_OF_MEAN|17.755||0.4823|TWO_SIDED|95.0|-22.757|47.811|||ANCOVA|The baseline value was included as a continuous covariate||Difference calculated as empa 1mg minus placebo||47.811|-22.757|0.4823
72610431|NCT00885118|144749727|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.984|STANDARD_ERROR_OF_MEAN|17.313||0.7305|TWO_SIDED|95.0|-28.422|40.39|||ANCOVA|The baseline value was included as a continuous covariate||Difference calculated as empa 5mg minus placebo||40.390|-28.422|0.7305
72610432|NCT00885118|144749727|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.858|STANDARD_ERROR_OF_MEAN|17.903||0.3213|TWO_SIDED|95.0|-53.438|17.721|||ANCOVA|The baseline value was included as a continuous covariate||Difference calculated as empa 10mg minus placebo||17.721|-53.438|0.3213
72610433|NCT00885118|144749727|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.838|STANDARD_ERROR_OF_MEAN|18.13||0.2768|TWO_SIDED|95.0|-55.869|16.192|||ANCOVA|The baseline value was included as a continuous covariate||Difference calculated as empa 25mg minus placebo||16.192|-55.869|0.2768
72610434|NCT00885118|144749728|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.192|STANDARD_ERROR_OF_MEAN|0.728|<|0.0001|TWO_SIDED|95.0|-5.653|-2.731|||ANCOVA|The baseline value was included as a continuous covariate||Difference calculated as empa 1mg minus placebo||-2.731|-5.653|<0.0001
72610435|NCT00885118|144749728|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.609|STANDARD_ERROR_OF_MEAN|0.756|<|0.0001||95.0|-6.126|-3.091|||ANCOVA|The baseline value was included as a continuous covariate||Difference calculated as empa 5mg minus placebo||-3.091|-6.126|<0.0001
72610436|NCT00885118|144749728|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.036|STANDARD_ERROR_OF_MEAN|0.762|<|0.0001|TWO_SIDED|95.0|-5.565|-2.508|||ANCOVA|The baseline value was included as a continuous covariate||Difference calculated as empa 10mg minus placebo||-2.508|-5.565|<0.0001
72610437|NCT00885118|144749728|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.887|STANDARD_ERROR_OF_MEAN|1.076|<|0.0001|TWO_SIDED|95.0|-7.048|-2.726|||ANCOVA|The baseline value was included as a continuous covariate||Difference calculated as empa 25mg minus placebo||-2.726|-7.048|<0.0001
72610438|NCT00885118|144749729|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.48|STANDARD_ERROR_OF_MEAN|0.414||0.2498|TWO_SIDED|95.0|-1.302|0.343|||ANCOVA|The baseline value was included as a continuous covariate||Difference calculated as empa 1mg minus placebo||0.343|-1.302|0.2498
72610439|NCT00885118|144749729|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.379|STANDARD_ERROR_OF_MEAN|0.408||0.3544|TWO_SIDED|95.0|-1.189|0.43|||ANCOVA|The baseline value was included as a continuous covariate||Difference calculated as empa 5mg minus placebo||0.430|-1.189|0.3544
72610440|NCT00885118|144749729|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.343|STANDARD_ERROR_OF_MEAN|0.416||0.0018|TWO_SIDED|95.0|-2.171|-0.516|||ANCOVA|The baseline value was included as a continuous covariate||Difference calculated as empa 10mg minus placebo||-0.516|-2.171|0.0018
72610441|NCT00885118|144749729|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.257|STANDARD_ERROR_OF_MEAN|0.421||0.0037|TWO_SIDED|95.0|-2.094|-0.419|||ANCOVA|The baseline value was included as a continuous covariate||Difference calculated as empa 25mg minus placebo||-0.419|-2.094|0.0037
72610442|NCT00885118|144749730|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-95.414|STANDARD_ERROR_OF_MEAN|15.388|<|0.0001|TWO_SIDED|95.0|-125.995|-64.833|||ANCOVA|The baseline value was included as a continuous covariate||Difference calculated as empa 1mg minus placebo||-64.833|-125.995|<0.0001
72610443|NCT00885118|144749730|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-109.48|STANDARD_ERROR_OF_MEAN|14.67|<|0.0001|TWO_SIDED|95.0|-138.633|-80.327|||ANCOVA|The baseline value was included as a continuous covariate||Difference calculated as empa 5mg minus placebo||-80.327|-138.633|<0.0001
72610444|NCT00885118|144749730|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-131.336|STANDARD_ERROR_OF_MEAN|15.354|<|0.0001|TWO_SIDED|95.0|-161.848|-100.824|||ANCOVA|The baseline value was included as a continuous covariate||Difference calculated as empa 10mg minus placebo||-100.824|-161.848|<0.0001
72610445|NCT00885118|144749730|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-136.341|STANDARD_ERROR_OF_MEAN|15.357|<|0.0001|TWO_SIDED|95.0|-166.86|-105.823|||ANCOVA|The baseline value was included as a continuous covariate||Difference calculated as empa 25mg minus placebo||-105.823|-166.860|<0.0001
72610446|NCT00885118|144749731|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|22.668|STANDARD_ERROR_OF_MEAN|13.152||0.0883|TWO_SIDED|95.0|-3.47|48.805|||ANCOVA|The baseline value was included as a continuous covariate||Difference calculated as empa 1mg minus placebo||48.805|-3.470|0.0883
72610447|NCT00885118|144749731|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|30.576|STANDARD_ERROR_OF_MEAN|12.941||0.0203|TWO_SIDED|95.0|4.859|56.293|||ANCOVA|The baseline value was included as a continuous covariate||Difference calculated as empa 5mg minus placebo||56.293|4.859|0.0203
72610448|NCT00885118|144749731|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.974|STANDARD_ERROR_OF_MEAN|13.289||0.6541|TWO_SIDED|95.0|-20.434|32.382|||ANCOVA|The baseline value was included as a continuous covariate||Difference calculated as empa 10mg minus placebo||32.382|-20.434|0.6541
72610449|NCT00885118|144749731|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.015|STANDARD_ERROR_OF_MEAN|13.612||0.4206|TWO_SIDED|95.0|-16.036|38.066|||ANCOVA|The baseline value was included as a continuous covariate||Difference calculated as empa 25mg minus placebo||38.066|-16.036|0.4206
72610450|NCT00885118|144749732|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.869|STANDARD_ERROR_OF_MEAN|4.066||0.0318|TWO_SIDED|95.0|-16.949|-0.789|||ANCOVA|The baseline value was included as a continuous covariate||Difference calculated as empa 1mg minus placebo||-0.789|-16.949|0.0318
72610451|NCT00885118|144749732|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.344|STANDARD_ERROR_OF_MEAN|3.966||0.0005|TWO_SIDED|95.0|-22.225|-6.462|||ANCOVA|The baseline value was included as a continuous covariate||Difference calculated as empa 5mg minus placebo||-6.462|-22.225|0.0005
72610452|NCT00885118|144749732|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.642|STANDARD_ERROR_OF_MEAN|4.131||0.0003|TWO_SIDED|95.0|-23.853|-7.432|||ANCOVA|The baseline value was included as a continuous covariate||Difference calculated as empa 10mg minus placebo||-7.432|-23.853|0.0003
72610453|NCT00885118|144749732|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.118|STANDARD_ERROR_OF_MEAN|4.137||0.0164|TWO_SIDED|95.0|-18.339|-1.897|||ANCOVA|The baseline value was included as a continuous covariate||Difference calculated as empa 25mg minus placebo||-1.897|-18.339|0.0164
72326194|NCT02722408|144175860|OTHER|||||||0.2892||||||Mixed-effects model for repeated measures analysis with percent change in Non-HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84 (Negative LDLr)||||0.2892
72326195|NCT02722408|144175860|OTHER|||||||0.0052||||||Mixed-effects model for repeated measures analysis with percent change in Non-HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28 (Defective LDLr)||||0.0052
72610454|NCT03054428|144749757|SUPERIORITY||percentage difference|22.0|||<|0.0001|TWO_SIDED|95.0|12.2|31.87||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control type I error. Analysis was performed using Cochran-Mantel-Haenszel (CMH) test stratified by baseline disease severity (IGA=3 vs IGA=4) and baseline weight group (less than \[\<\] 60 kilogram \[kg\] vs greater than or equal to \[≥\] 60 kg).||31.87|12.2|< 0.0001
72610455|NCT03054428|144749757|SUPERIORITY||percentage difference|15.5|||=|0.0007|TWO_SIDED|95.0|6.7|24.31||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control type I error. Analysis was performed using CMH test stratified by baseline disease severity (IGA=3 vs IGA=4) and baseline weight group (\<60 kg vs ≥60 kg).||24.31|6.7|= 0.0007
72610456|NCT03054428|144749758|SUPERIORITY||percentage difference|33.2|||<|0.0001|TWO_SIDED|95.0|21.07|45.39||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control type I error. Analysis was performed using CMH test stratified by baseline disease severity (IGA=3 vs IGA=4) and baseline weight group (\<60 kg vs ≥60 kg).||45.39|21.07|< 0.0001
72610457|NCT03054428|144749758|SUPERIORITY||percentage difference|29.9|||<|0.0001|TWO_SIDED|95.0|17.94|41.78||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control type I error. Analysis was performed using CMH test stratified by baseline disease severity (IGA=3 vs IGA=4) and baseline weight group (\<60 kg vs ≥60 kg).||41.78|17.94|< 0.0001
72610458|NCT03054428|144749759|SUPERIORITY||Least Square (LS) Mean difference|-42.3|||<|0.0001|TWO_SIDED|95.0|-55.6|-29.04||Threshold for significance at 0.05 level.|ANCOVA|||A hierarchical testing procedure was used to control type I error. The confidence interval (CI) with p-value is based on treatment difference (Dupilumab group vs. Placebo) of the LS mean percent change using analysis of covariance (ANCOVA) model with baseline measurement as covariate and the treatment, randomization strata (baseline disease severity \[IGA=3 vs IGA=4\] and baseline weight group \[\<60 kg vs ≥60 kg\]) as fixed factors.||-29.04|-55.6|< 0.0001
72610459|NCT03054428|144749759|SUPERIORITY||LS Mean difference|-41.2|||<|0.0001|TWO_SIDED|95.0|-54.44|-28.02||Threshold for significance at 0.05 level.|ANCOVA|||A hierarchical testing procedure was used to control type I error. The confidence interval (CI) with p-value is based on treatment difference (Dupilumab group vs. Placebo) of the LS mean percent change using ANCOVA model with baseline measurement as covariate and the treatment, randomization strata (baseline disease severity \[IGA=3 vs IGA=4\] and baseline weight group \[\<60 kg vs ≥60 kg\]) as fixed factors.||-28.02|-54.44|< 0.0001
72610460|NCT03054428|144749760|SUPERIORITY||LS Mean difference|-29.0|||<|0.0001|TWO_SIDED|95.0|-39.54|-18.38||Threshold for significance at 0.05 level.|ANCOVA|||A hierarchical testing procedure was used to control type I error. The confidence interval (CI) with p-value is based on treatment difference (Dupilumab group vs. Placebo) of the LS mean percent change using ANCOVA model with baseline measurement as covariate and the treatment, randomization strata (baseline disease severity \[IGA=3 vs IGA=4\] and baseline weight group \[\<60 kg vs ≥60 kg\]) as fixed factors.||-18.38|-39.54|< 0.0001
72610461|NCT03054428|144749760|SUPERIORITY||LS Mean difference|-26.5|||<|0.0001|TWO_SIDED|95.0|-37.45|15.63||Threshold for significance at 0.05 level.|ANCOVA|||A hierarchical testing procedure was used to control type I error. The confidence interval (CI) with p-value is based on treatment difference (Dupilumab group vs. Placebo) of the LS mean percent change using ANCOVA model with baseline measurement as covariate and the treatment, randomization strata (baseline disease severity \[IGA=3 vs IGA=4\] and baseline weight group \[\<60 kg vs ≥60 kg\]) as fixed factors.||15.63|-37.45|< 0.0001
72610462|NCT03054428|144749761|SUPERIORITY||percentage difference|39.4|||<|0.0001|TWO_SIDED|95.0|26.9|51.84||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control type I error. Difference is Dupilumab minus Placebo. C.I. = Confidence interval calculated using normal approximation. P-values were derived by CMH test stratified by baseline disease severity \[IGA=3 vs IGA=4\] and baseline weight group \[\<60 kg vs ≥60 kg\].||51.84|26.9|< 0.0001
72418173|NCT03318523|144346606|SUPERIORITY|Adjusted mean, difference with placebo, 95% CI, and p-value were based on an MMRM model, with change from baseline in DaT/SPECT parameter as dependent variable and with fixed effects of treatment group, region, time, treatment group-by-time interaction, baseline MDS-UPDRS part I+II+III total score, baseline MDS-UPDRS part I+II+III total score by time interaction, baseline DaT/SPECT values and baseline DaT/SPECT by time interaction.|Difference|-0.009||||0.7079|TWO_SIDED|95.0|-0.0562|0.0382|||Mixed Model for Repeated Measures|||||0.0382|-0.0562|0.7079
72418174|NCT03318523|144346606|SUPERIORITY|Adjusted mean, difference with placebo, 95% CI, and p-value were based on an MMRM model, with change from baseline in DaT/SPECT parameter as dependent variable and with fixed effects of treatment group, region, time, treatment group-by-time interaction, baseline MDS-UPDRS part I+II+III total score, baseline MDS-UPDRS part I+II+III total score by time interaction, baseline DaT/SPECT values and baseline DaT/SPECT by time interaction.|Difference|0.0||||0.9835|TWO_SIDED|95.0|-0.04|0.0392|||Mixed Model for Repeated Measures|||||0.0392|-0.0400|0.9835
72418175|NCT03318523|144346606|SUPERIORITY|Adjusted mean, difference with placebo, 95% CI, and p-value were based on an MMRM model, with change from baseline in DaT/SPECT parameter as dependent variable and with fixed effects of treatment group, region, time, treatment group-by-time interaction, baseline MDS-UPDRS part I+II+III total score, baseline MDS-UPDRS part I+II+III total score by time interaction, baseline DaT/SPECT values and baseline DaT/SPECT by time interaction.|Difference|-0.027||||0.1869|TWO_SIDED|95.0|-0.0682|0.0134|||Mixed Model for Repeated Measures|||||0.0134|-0.0682|0.1869
72610463|NCT03054428|144749761|SUPERIORITY||percentage difference|29.1|||<|0.0001|TWO_SIDED|95.0|16.97|41.32||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control type I error. Difference is Dupilumab minus Placebo. C.I. = Confidence interval calculated using normal approximation. P-values were derived by Cochran-Mantel-Haenszel (CMH) test stratified by baseline disease severity \[IGA=3 vs IGA=4\] and baseline weight group \[\<60 kg vs ≥60 kg\].||41.32|16.97|< 0.0001
72610464|NCT03054428|144749762|SUPERIORITY||Percentage difference|31.8|||<|0.0001|TWO_SIDED|95.0|20.45|43.2||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control type I error. Difference is Dupilumab minus Placebo. C.I. = Confidence interval calculated using normal approximation. P-values were derived by Cochran-Mantel-Haenszel (CMH) test stratified by baseline disease severity \[IGA=3 vs IGA=4\] and baseline weight group \[\<60 kg vs ≥60 kg\].||43.2|20.45|< 0.0001
72610465|NCT03054428|144749762|SUPERIORITY||Percentage difference|21.7|||=|0.0001|TWO_SIDED|95.0|11.21|32.28||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control type I error. Difference is Dupilumab minus Placebo. C.I. = Confidence interval calculated using normal approximation. P-values were derived by Cochran-Mantel-Haenszel (CMH) test stratified by baseline disease severity \[IGA=3 vs IGA=4\] and baseline weight group \[\<60 kg vs ≥60 kg\].||32.28|11.21|= 0.0001
72610466|NCT03082729|144749792|SUPERIORITY|||||||0.612|||||||t-test, 2 sided|||||||0.612
72610467|NCT03082729|144749793|SUPERIORITY|||||||0.083|||||||t-test, 2 sided|||||||0.083
72610468|NCT03082729|144749794|SUPERIORITY|||||||0.617|||||||t-test, 2 sided|||||||0.617
72610469|NCT03082729|144749795|SUPERIORITY|||||||0.524|||||||t-test, 2 sided|||||||0.524
72610470|NCT03082729|144749796|SUPERIORITY|||||||0.972|||||||t-test, 2 sided|||||||0.972
72610471|NCT03082729|144749797|SUPERIORITY|||||||0.315|||||||t-test, 2 sided|||||||0.315
72610472|NCT03082729|144749798|SUPERIORITY|||||||0.443|||||||t-test, 2 sided|||||||0.443
72610473|NCT03082729|144749799|SUPERIORITY|||||||0.027|||||||t-test, 2 sided|||||||0.027
72610474|NCT03082729|144749800|SUPERIORITY|||||||0.39|||||||t-test, 2 sided|||||||0.390
72610475|NCT03082729|144749801|SUPERIORITY|||||||0.116|||||||t-test, 2 sided|||||||0.116
72610476|NCT03082729|144749802|SUPERIORITY|||||||0.331|||||||t-test, 2 sided|||||||0.331
72610477|NCT03082729|144749803|SUPERIORITY|||||||0.225|||||||t-test, 2 sided|||||||0.225
72610478|NCT03082729|144749804|SUPERIORITY|||||||0.141|||||||t-test, 2 sided|||||||0.141
72610479|NCT03082729|144749805|SUPERIORITY|||||||0.882|||||||t-test, 2 sided|||||||0.882
72610480|NCT03082729|144749806|SUPERIORITY|||||||0.326|||||||t-test, 2 sided|||||||0.326
72610481|NCT03082729|144749807|SUPERIORITY|||||||0.094|||||||t-test, 2 sided|||||||0.094
72610482|NCT03082729|144749808|SUPERIORITY|||||||0.087|||||||t-test, 2 sided|||||||0.087
72610483|NCT03082729|144749809|SUPERIORITY|||||||0.771|||||||t-test, 2 sided|||||||0.771
72610484|NCT03082729|144749810|SUPERIORITY|||||||0.491|||||||t-test, 2 sided|||||||0.491
72610485|NCT03082729|144749811|SUPERIORITY|||||||0.924|||||||t-test, 2 sided|||||||0.924
72610486|NCT03082729|144749812|SUPERIORITY|||||||0.868|||||||t-test, 2 sided|||||||0.868
72610487|NCT03082729|144749813|SUPERIORITY|||||||0.922|||||||t-test, 2 sided|||||||0.922
72610488|NCT03082729|144749814|SUPERIORITY|||||||0.192|||||||t-test, 2 sided|||||||0.192
72610489|NCT03082729|144749815|SUPERIORITY|||||||0.453|||||||t-test, 2 sided|||||||0.453
72610490|NCT03082729|144749816|SUPERIORITY|||||||0.714|||||||t-test, 2 sided|||||||0.714
72610491|NCT03082729|144749817|SUPERIORITY|||||||0.434|||||||t-test, 2 sided|||||||0.434
72610492|NCT03082729|144749818|SUPERIORITY|||||||0.329|||||||t-test, 2 sided|||||||0.329
72610493|NCT03082729|144749819|SUPERIORITY|||||||0.963|||||||t-test, 2 sided|||||||0.963
72610494|NCT03082729|144749820|SUPERIORITY|||||||0.4|||||||t-test, 2 sided|||||||0.400
72610495|NCT03082729|144749821|SUPERIORITY|||||||0.223|||||||t-test, 2 sided|||||||0.223
72610496|NCT03082729|144749822|SUPERIORITY|||||||0.241|||||||t-test, 2 sided|||||||0.241
72610497|NCT03082729|144749823|SUPERIORITY|||||||0.348|||||||t-test, 2 sided|||||||0.348
72610498|NCT03082729|144749824|SUPERIORITY|||||||0.424|||||||t-test, 2 sided|||||||0.424
72610499|NCT03082729|144749825|SUPERIORITY|||||||0.667|||||||t-test, 2 sided|||||||0.667
72610500|NCT03082729|144749826|SUPERIORITY|||||||0.135|||||||t-test, 2 sided|||||||0.135
72610501|NCT03082729|144749827|SUPERIORITY|||||||0.331|||||||t-test, 2 sided|||||||0.331
72610502|NCT03082729|144749828|SUPERIORITY|||||||0.538|||||||t-test, 2 sided|||||||0.538
72610503|NCT03082729|144749829|SUPERIORITY|||||||0.791|||||||t-test, 2 sided|||||||0.791
72610504|NCT03082729|144749830|SUPERIORITY|||||||0.925|||||||t-test, 2 sided|||||||0.925
72418176|NCT03318523|144346607|SUPERIORITY|Adjusted mean, difference with placebo, 95% CI, and p-value were based on an MMRM model, with change from baseline in DaT/SPECT parameter as dependent variable and with fixed effects of treatment group, region, time, treatment group-by-time interaction, baseline MDS-UPDRS part I+II+III total score, baseline MDS-UPDRS part I+II+III total score by time interaction, baseline DaT/SPECT values and baseline DaT/SPECT by time interaction.|Difference|-0.008||||0.7585|TWO_SIDED|95.0|-0.0625|0.0456|||Mixed Model for Repeated Measures|||||0.0456|-0.0625|0.7585
72418177|NCT03318523|144346607|SUPERIORITY|Adjusted mean, difference with placebo, 95% CI, and p-value were based on an MMRM model, with change from baseline in DaT/SPECT parameter as dependent variable and with fixed effects of treatment group, region, time, treatment group-by-time interaction, baseline MDS-UPDRS part I+II+III total score, baseline MDS-UPDRS part I+II+III total score by time interaction, baseline DaT/SPECT values and baseline DaT/SPECT by time interaction.|Difference|0.006||||0.7808|TWO_SIDED|95.0|-0.0391|0.052|||Mixed Model for Repeated Measures|||||0.0520|-0.0391|0.7808
72418178|NCT03318523|144346607|SUPERIORITY|Adjusted mean, difference with placebo, 95% CI, and p-value were based on an MMRM model, with change from baseline in DaT/SPECT parameter as dependent variable and with fixed effects of treatment group, region, time, treatment group-by-time interaction, baseline MDS-UPDRS part I+II+III total score, baseline MDS-UPDRS part I+II+III total score by time interaction, baseline DaT/SPECT values and baseline DaT/SPECT by time interaction.|Difference|-0.022||||0.3532|TWO_SIDED|95.0|-0.0691|0.0248|||Mixed Model for Repeated Measures|||||0.0248|-0.0691|0.3532
72418179|NCT03581981|144346610|SUPERIORITY|see statistical plan|Mean Difference (Final Values)|-3.6||||0.33|TWO_SIDED|95.0|-10.7|3.6|||Mixed Models Analysis|||||3.6|-10.7|0.33
72418180|NCT03581981|144346611|SUPERIORITY||Mean Difference (Final Values)|0.61||||0.89|TWO_SIDED||||||Mixed Models Analysis|||||||0.89
72418181|NCT03581981|144346612|SUPERIORITY||Mean Difference (Final Values)|0.61||||0.89|TWO_SIDED||||||Mixed Models Analysis|||||||0.89
72610505|NCT03082729|144749831|SUPERIORITY|||||||0.161|||||||t-test, 2 sided|||||||0.161
72610506|NCT03082729|144749832|SUPERIORITY|||||||0.546|||||||t-test, 2 sided|||||||0.546
72610507|NCT03082729|144749833|SUPERIORITY|||||||0.667|||||||t-test, 2 sided|||||||0.667
72610508|NCT03082729|144749834|SUPERIORITY|||||||0.84|||||||t-test, 2 sided|||||||0.840
72610509|NCT03082729|144749835|SUPERIORITY|||||||0.367|||||||t-test, 2 sided|||||||0.367
72610510|NCT03082729|144749836|SUPERIORITY|||||||0.773|||||||t-test, 2 sided|||||||0.773
72610511|NCT03082729|144749837|SUPERIORITY|||||||0.968|||||||t-test, 2 sided|||||||0.968
72610512|NCT03082729|144749838|SUPERIORITY|||||||0.953|||||||t-test, 2 sided|||||||0.953
72610513|NCT03082729|144749839|SUPERIORITY|||||||0.911|||||||t-test, 2 sided|||||||0.911
72610514|NCT03082729|144749840|SUPERIORITY|||||||0.944|||||||t-test, 2 sided|||||||0.944
72610515|NCT03082729|144749841|SUPERIORITY|||||||0.226|||||||t-test, 2 sided|||||||0.226
72610516|NCT03082729|144749842|SUPERIORITY|||||||0.988|||||||t-test, 2 sided|||||||0.988
72610517|NCT03082729|144749843|SUPERIORITY|||||||0.189|||||||t-test, 2 sided|||||||0.189
72610518|NCT03082729|144749844|SUPERIORITY|||||||0.488|||||||t-test, 2 sided|||||||0.488
72610519|NCT03082729|144749845|SUPERIORITY|||||||0.523|||||||t-test, 2 sided|||||||0.523
72610520|NCT03082729|144749846|SUPERIORITY|||||||0.06|||||||t-test, 2 sided|||||||0.060
72610521|NCT03082729|144749847|SUPERIORITY|||||||0.777|||||||t-test, 2 sided|||||||0.777
72610522|NCT03082729|144749848|SUPERIORITY|||||||0.946|||||||t-test, 2 sided|||||||0.946
72610523|NCT03082729|144749849|SUPERIORITY|||||||0.351|||||||t-test, 2 sided|||||||0.351
72610524|NCT03082729|144749850|SUPERIORITY|||||||0.041|||||||t-test, 2 sided|||||||0.041
72610525|NCT03082729|144749851|SUPERIORITY|||||||0.884|||||||t-test, 2 sided|||||||0.884
72610526|NCT03082729|144749852|SUPERIORITY|||||||0.018|||||||t-test, 2 sided|||||||0.018
72610527|NCT03082729|144749853|SUPERIORITY|||||||0.046|||||||t-test, 2 sided|||||||0.046
72610528|NCT03082729|144749854|SUPERIORITY|||||||0.018|||||||t-test, 2 sided|||||||0.018
72610529|NCT03082729|144749855|SUPERIORITY|||||||0.283|||||||t-test, 2 sided|||||||0.283
72610530|NCT03082729|144749856|SUPERIORITY|||||||0.01|||||||t-test, 2 sided|||||||0.010
72610531|NCT03082729|144749857|SUPERIORITY|||||||0.371|||||||t-test, 2 sided|||||||0.371
72610532|NCT03082729|144749858|SUPERIORITY|||||||0.555|||||||t-test, 2 sided|||||||0.555
72610533|NCT03082729|144749859|SUPERIORITY|||||||0.533|||||||t-test, 2 sided|||||||0.533
72610534|NCT03082729|144749860|SUPERIORITY|||||||0.137|||||||t-test, 2 sided|||||||0.137
72610535|NCT03082729|144749861|SUPERIORITY|||||||0.001|||||||t-test, 2 sided|||||||0.001
72610536|NCT03082729|144749861|SUPERIORITY|||||||0.015|||||||t-test, 2 sided|||||||0.015
72610537|NCT03082729|144749861|SUPERIORITY|||||||0.537|||||||t-test, 2 sided|||||||0.537
72610538|NCT03082729|144749862|SUPERIORITY|||||||0.001|||||||t-test, 2 sided|||||||0.001
72610539|NCT03082729|144749862|SUPERIORITY|||||||0.01|||||||t-test, 2 sided|||||||0.010
72610540|NCT03082729|144749862|SUPERIORITY|||||||0.918|||||||t-test, 2 sided|||||||0.918
72610541|NCT03082729|144749863|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
72610542|NCT03082729|144749863|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
72610543|NCT03082729|144749864|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
72610544|NCT03082729|144749864|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
72610545|NCT03082729|144749865|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
72610546|NCT03082729|144749865|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
72610547|NCT03082729|144749866|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
72610548|NCT03082729|144749866|SUPERIORITY|||||||0.004|||||||t-test, 2 sided|||||||0.004
72610549|NCT03082729|144749868|SUPERIORITY|||||||0.092|||||||t-test, 2 sided|||||||0.092
72610550|NCT03082729|144749868|SUPERIORITY|||||||0.678|||||||t-test, 2 sided|||||||0.678
72610551|NCT03082729|144749869|SUPERIORITY|||||||0.02|||||||t-test, 2 sided|||||||0.020
72610552|NCT03082729|144749869|SUPERIORITY|||||||0.762|||||||t-test, 2 sided|||||||0.762
72610553|NCT03082729|144749870|SUPERIORITY|||||||0.973|||||||t-test, 2 sided|||||||0.973
72610554|NCT03082729|144749870|SUPERIORITY|||||||0.805|||||||t-test, 2 sided|||||||0.805
72610555|NCT03082729|144749871|SUPERIORITY|||||||0.951|||||||t-test, 2 sided|||||||0.951
72610556|NCT03082729|144749871|SUPERIORITY|||||||0.661|||||||t-test, 2 sided|||||||0.661
72610557|NCT03082729|144749872|SUPERIORITY|||||||0.614|||||||t-test, 2 sided|||||||0.614
72610558|NCT03082729|144749872|SUPERIORITY|||||||0.306|||||||t-test, 2 sided|||||||0.306
72610559|NCT03082729|144749873|SUPERIORITY|||||||0.322|||||||t-test, 2 sided|||||||0.322
72610560|NCT03082729|144749873|SUPERIORITY|||||||0.032|||||||t-test, 2 sided|||||||0.032
72610561|NCT03082729|144749874|SUPERIORITY|||||||0.96|||||||t-test, 2 sided|||||||0.960
72610562|NCT03082729|144749874|SUPERIORITY|||||||0.268|||||||t-test, 2 sided|||||||0.268
72610563|NCT03082729|144749875|SUPERIORITY|||||||0.501|||||||t-test, 2 sided|||||||0.501
72610564|NCT03082729|144749875|SUPERIORITY|||||||0.235|||||||t-test, 2 sided|||||||0.235
72610565|NCT03082729|144749876|SUPERIORITY|||||||0.259|||||||t-test, 2 sided|||||||0.259
72610566|NCT03082729|144749876|SUPERIORITY|||||||0.219|||||||t-test, 2 sided|||||||0.219
72610567|NCT03082729|144749877|SUPERIORITY|||||||0.14|||||||t-test, 2 sided|||||||0.140
72610568|NCT03082729|144749877|SUPERIORITY|||||||0.633|||||||t-test, 2 sided|||||||0.633
72610569|NCT03082729|144749878|SUPERIORITY|||||||0.302|||||||t-test, 2 sided|||||||0.302
72610570|NCT03082729|144749878|SUPERIORITY|||||||0.405|||||||t-test, 2 sided|||||||0.405
72610571|NCT03082729|144749879|SUPERIORITY|||||||0.297|||||||t-test, 2 sided|||||||0.297
72610572|NCT03082729|144749879|SUPERIORITY|||||||0.324|||||||t-test, 2 sided|||||||0.324
72610573|NCT03082729|144749880|SUPERIORITY|||||||0.812|||||||t-test, 2 sided|||||||0.812
72610574|NCT03082729|144749880|SUPERIORITY|||||||0.264|||||||t-test, 2 sided|||||||0.264
72610575|NCT03082729|144749881|SUPERIORITY|||||||0.283|||||||t-test, 2 sided|||||||0.283
72610576|NCT03082729|144749881|SUPERIORITY|||||||0.25|||||||t-test, 2 sided|||||||0.250
72610577|NCT03082729|144749882|SUPERIORITY|||||||0.17|||||||t-test, 2 sided|||||||0.170
72610578|NCT03082729|144749882|SUPERIORITY|||||||0.249|||||||t-test, 2 sided|||||||0.249
72610579|NCT03082729|144749883|SUPERIORITY|||||||0.526|||||||t-test, 2 sided|||||||0.526
72610580|NCT03082729|144749883|SUPERIORITY|||||||0.632|||||||t-test, 2 sided|||||||0.632
72610581|NCT03082729|144749884|SUPERIORITY|||||||0.584|||||||t-test, 2 sided|||||||0.584
72610582|NCT03082729|144749884|SUPERIORITY|||||||0.191|||||||t-test, 2 sided|||||||0.191
72610583|NCT03082729|144749885|SUPERIORITY|||||||0.005|||||||t-test, 2 sided|||||||0.005
72610584|NCT03082729|144749885|SUPERIORITY|||||||0.004|||||||t-test, 2 sided|||||||0.004
72610585|NCT03082729|144749886|SUPERIORITY|||||||0.533|||||||t-test, 2 sided|||||||0.533
72610586|NCT03082729|144749886|SUPERIORITY|||||||0.079|||||||t-test, 2 sided|||||||0.079
72610587|NCT03082729|144749887|SUPERIORITY|||||||0.338|||||||t-test, 2 sided|||||||0.338
72610588|NCT03082729|144749887|SUPERIORITY|||||||0.091|||||||t-test, 2 sided|||||||0.091
72610589|NCT03082729|144749888|SUPERIORITY|||||||0.102|||||||t-test, 2 sided|||||||0.102
72610590|NCT03082729|144749888|SUPERIORITY|||||||0.153|||||||t-test, 2 sided|||||||0.153
72610591|NCT03082729|144749889|SUPERIORITY|||||||0.226|||||||t-test, 2 sided|||||||0.226
72610592|NCT03082729|144749889|SUPERIORITY|||||||0.222|||||||t-test, 2 sided|||||||0.222
72610593|NCT03082729|144749890|SUPERIORITY|||||||0.384|||||||t-test, 2 sided|||||||0.384
72610594|NCT03082729|144749890|SUPERIORITY|||||||0.112|||||||t-test, 2 sided|||||||0.112
72610595|NCT03082729|144749891|SUPERIORITY|||||||0.636|||||||t-test, 2 sided|||||||0.636
72610596|NCT03082729|144749891|SUPERIORITY|||||||0.896|||||||t-test, 2 sided|||||||0.896
72610597|NCT03082729|144749892|SUPERIORITY|||||||0.8|||||||t-test, 2 sided|||||||0.800
72610598|NCT03082729|144749892|SUPERIORITY|||||||0.551|||||||t-test, 2 sided|||||||0.551
72610599|NCT03082729|144749893|SUPERIORITY|||||||0.44|||||||t-test, 2 sided|||||||0.440
72610600|NCT03082729|144749893|SUPERIORITY|||||||0.17|||||||t-test, 2 sided|||||||0.170
72610601|NCT03082729|144749894|SUPERIORITY|||||||0.278|||||||t-test, 2 sided|||||||0.278
72610602|NCT03082729|144749894|SUPERIORITY|||||||0.089|||||||t-test, 2 sided|||||||0.089
72610603|NCT03082729|144749895|SUPERIORITY|||||||0.795|||||||t-test, 2 sided|||||||0.795
72610604|NCT03082729|144749895|SUPERIORITY|||||||0.284|||||||t-test, 2 sided|||||||0.284
72610605|NCT03082729|144749896|SUPERIORITY|||||||0.88|||||||t-test, 2 sided|||||||0.880
72610606|NCT03082729|144749896|SUPERIORITY|||||||0.028|||||||t-test, 2 sided|||||||0.028
72610607|NCT03082729|144749897|SUPERIORITY|||||||0.746|||||||t-test, 2 sided|||||||0.746
72610608|NCT03082729|144749897|SUPERIORITY|||||||0.199|||||||t-test, 2 sided|||||||0.199
72610609|NCT03082729|144749898|SUPERIORITY|||||||0.814|||||||t-test, 2 sided|||||||0.814
72610610|NCT03082729|144749898|SUPERIORITY|||||||0.036|||||||t-test, 2 sided|||||||0.036
72610611|NCT03082729|144749899|SUPERIORITY|||||||0.494|||||||t-test, 2 sided|||||||0.494
72610612|NCT03082729|144749899|SUPERIORITY|||||||0.96|||||||t-test, 2 sided|||||||0.960
72610613|NCT03082729|144749900|SUPERIORITY|||||||0.777|||||||t-test, 2 sided|||||||0.777
72610614|NCT03082729|144749900|SUPERIORITY|||||||0.028|||||||t-test, 2 sided|||||||0.028
72610615|NCT03082729|144749901|SUPERIORITY|||||||0.241|||||||t-test, 2 sided|||||||0.241
72610616|NCT03082729|144749901|SUPERIORITY|||||||0.869|||||||t-test, 2 sided|||||||0.869
72610617|NCT03082729|144749902|SUPERIORITY|||||||0.977|||||||t-test, 2 sided|||||||0.977
72610618|NCT03082729|144749902|SUPERIORITY|||||||0.012|||||||t-test, 2 sided|||||||0.012
72610619|NCT03082729|144749903|SUPERIORITY|||||||0.591|||||||t-test, 2 sided|||||||0.591
72326196|NCT02722408|144175860|OTHER|||||||0.0028||||||Mixed-effects model for repeated measures analysis with percent change in Non-HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56 (Negative LDLr)||||0.0028
72418182|NCT03581981|144346613|SUPERIORITY||Mean Difference (Final Values)|0.02||||0.99|TWO_SIDED|95.0|-3.6|3.6|||Mixed Models Analysis|||||3.6|-3.6|0.99
72326197|NCT02722408|144175860|OTHER|||||||0.0026||||||Mixed-effects model for repeated measures analysis with percent change in Non-HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84 (Negative LDLr)||||0.0026
72326198|NCT02722408|144175860|OTHER|||||||0.0493||||||Mixed-effects model for repeated measures analysis with percent change in Non-HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28 (Met EAS Clinical Diagnosis of HoFH)||||0.0493
72326199|NCT02722408|144175860|OTHER|||||||0.0253||||||Mixed-effects model for repeated measures analysis with percent change in Non-HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28 (Met EAS Clinical Diagnosis of HoFH)||||0.0253
72326200|NCT02722408|144175860|OTHER|||||||0.0394||||||Mixed-effects model for repeated measures analysis with percent change in Non-HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84 (Met EAS Clinical Diagnosis of HoFH)||||0.0394
72326201|NCT02722408|144175860|OTHER|||||||0.0003||||||Mixed-effects model for repeated measures analysis with percent change in Non-HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28 (Not Met EAS Clinical Diagnosis of HoFH)||||0.0003
72326202|NCT02722408|144175860|OTHER|||||||0.0002||||||Mixed-effects model for repeated measures analysis with percent change in Non-HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56 (Not Met EAS Clinical Diagnosis of HoFH)||||0.0002
72326203|NCT02722408|144175860|OTHER|||||||0.0002||||||Mixed-effects model for repeated measures analysis with percent change in Non-HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84 (Not Met EAS Clinical Diagnosis of HoFH)||||0.0002
72326204|NCT02722408|144175861|OTHER|||||||0.3833||||||Mixed-effects model for repeated measures analysis with change in Non-HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28 (Negative LDLr)||||0.3833
72326205|NCT02722408|144175861|OTHER|||||||0.2172||||||Mixed-effects model for repeated measures analysis with change in Non-HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56 (Negative LDLr)||||0.2172
72326206|NCT02722408|144175861|OTHER|||||||0.293||||||Mixed-effects model for repeated measures analysis with change in Non-HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84 (Negative LDLr)||||0.2930
72326207|NCT02722408|144175861|OTHER|||||||0.1217||||||Mixed-effects model for repeated measures analysis with change in Non-HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28 (Defective LDLr)||||0.1217
72326208|NCT02722408|144175861|OTHER|||||||0.0901||||||Mixed-effects model for repeated measures analysis with change in Non-HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56 (Defective LDLr)||||0.0901
72326209|NCT02722408|144175861|OTHER|||||||0.085||||||Mixed-effects model for repeated measures analysis with change in Non-HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84 (Defective LDLr)||||0.0850
72326210|NCT02722408|144175861|OTHER|||||||0.0747||||||Mixed-effects model for repeated measures analysis with change in Non-HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28 (Met EAS Clinical Diagnosis of HoFH)||||0.0747
72326211|NCT02722408|144175861|OTHER|||||||0.0279||||||Mixed-effects model for repeated measures analysis with change in Non-HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56 (Met EAS Clinical Diagnosis of HoFH)||||0.0279
72326212|NCT02722408|144175861|OTHER|||||||0.0492||||||Mixed-effects model for repeated measures analysis with change in Non-HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84 (Met EAS Clinical Diagnosis of HoFH)||||0.0492
72326213|NCT02722408|144175861|OTHER|||||||0.0003||||||Mixed-effects model for repeated measures analysis with change in Non-HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28 (Not Met EAS Clinical Diagnosis of HoFH)||||0.0003
72326214|NCT02722408|144175861|OTHER|||||||0.0002||||||Mixed-effects model for repeated measures analysis with change in Non-HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56 (Not Met EAS Clinical Diagnosis of HoFH)||||0.0002
72326215|NCT02722408|144175861|OTHER|||||||0.0002||||||Mixed-effects model for repeated measures analysis with change in Non-HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84 (Not Met EAS Clinical Diagnosis of HoFH)||||0.0002
72326216|NCT02722408|144175862|OTHER|||||||0.8972||||||Mixed-effects model for repeated measures analysis with percent change in VLDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28 (Negative LDLr)||||0.8972
72326217|NCT02722408|144175862|OTHER|||||||0.7867||||||Mixed-effects model for repeated measures analysis with percent change in VLDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56 (Negative LDLr)||||0.7867
72418183|NCT03581981|144346614|SUPERIORITY||Mean Difference (Final Values)|-1.8||||0.52|TWO_SIDED|95.0|-7.3|3.7|||Mixed Models Analysis|||||3.7|-7.3|0.52
72326218|NCT02722408|144175862|OTHER|||||||0.4974||||||Mixed-effects model for repeated measures analysis with percent change in VLDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84 (Negative LDLr)||||0.4974
72326219|NCT02722408|144175862|OTHER|||||||0.5464||||||Mixed-effects model for repeated measures analysis with percent change in VLDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28 (Defective LDLr)||||0.5464
72326220|NCT02722408|144175862|OTHER|||||||0.7668||||||Mixed-effects model for repeated measures analysis with percent change in VLDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56 (Defective LDLr)||||0.7668
72418184|NCT03581981|144346615|SUPERIORITY||Mean Difference (Final Values)|0.7||||0.5|TWO_SIDED|95.0|-1.4|2.9|||Mixed Models Analysis|||||2.9|-1.4|0.50
72418185|NCT03581981|144346616|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.99|TWO_SIDED||||||Mixed Models Analysis|||||||0.99
72418186|NCT03581981|144346617|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.99|TWO_SIDED||||||Mixed Models Analysis|||||||0.99
72418187|NCT03581981|144346618|SUPERIORITY||Mean Difference (Final Values)|1.45||||0.69|TWO_SIDED||||||Mixed Models Analysis|||||||0.69
72418188|NCT03581981|144346619|SUPERIORITY||Mean Difference (Final Values)|1.45||||0.69|TWO_SIDED||||||Mixed Models Analysis|||||||0.69
72418189|NCT03581981|144346620|SUPERIORITY||Mean Difference (Final Values)|2.87||||0.41|TWO_SIDED||||||Mixed Models Analysis|||||||0.41
72418190|NCT03581981|144346621|SUPERIORITY||Mean Difference (Final Values)|2.87||||0.41|TWO_SIDED||||||Mixed Models Analysis|||||||0.41
72418191|NCT02080871|144346622|OTHER|This was a single-arm study designed to compare the primary outcome result to a performance goal based on published literature. The null hypothesis was the probability of a subject experiencing a Major Adverse Event (MAE) with use of study device is at least 17%. The alternate hypothesis was the probability of a subject experiencing a Major Adverse Event (MAE) with use of the study device is less than 17%.|||||<|0.001|||||||one-sided binomial exact test|||The sample size obtains over 90% power to statistically show the probability that a subject will experience an MAE with use of the study device is less than 17% when 12% or less of the subjects are lost to follow up prior to 9 months.||||<0.001
72418192|NCT03384173|144346714|SUPERIORITY||||||<|0.001|||||||ANOVA|||||||<0.001
72418193|NCT03384173|144346715|OTHER|Correlation, Pearson r|Pearson r correlation|0.16||||0.17|TWO_SIDED|95.0|-0.07|0.37|||Pearson r correlation|||||0.37|-0.07|0.17
72418194|NCT03384173|144346716|OTHER|Correlation, Pearson r|Pearson r correlation|0.12||||0.32|TWO_SIDED|95.0|-0.11|0.33|||Pearson r correlation|||||0.33|-0.11|0.32
72418195|NCT03384173|144346718|OTHER|Mann Whitney U non parametric test|||||<|0.01||||||"A-priori threshold p\<0.05 for 'subgroup 20-29.99%' vs 'baseline value before caffeine dose'.~A-priori threshold p\<0.05 for 'subgroup 30-39.99%' vs 'baseline value before caffeine dose'."|Wilcoxon (Mann-Whitney)|||Control group is Secondary analysis #4, baseline values before caffeine dose.||||<0.01
72418196|NCT03384173|144346719|OTHER|Mann Whitney U non parametric test|||||<|0.001||||||A-priori threshold p\<0.05 for 'subgroup 20-29.99%' vs 'baseline value before caffeine dose'.|Wilcoxon (Mann-Whitney)|||Control group is secondary outcome #4, baseline values before caffeine dose||||<0.001
72418197|NCT03384173|144346720|OTHER|Mann-Whitney U non parametric t test|||||<|0.01||||||"A-priori threshold p\<0.05 for 'subgroup 20-29.99%' vs 'baseline value before caffeine dose'.~A-priori threshold p\<0.05 for 'subgroup \>60% ' vs 'baseline value before caffeine dose'."|Wilcoxon (Mann-Whitney)|||Comparison group is Secondary outcome #4, baseline caffeine values by subgroup||||<0.01
72418198|NCT03384173|144346721|OTHER||||||<|0.0001||||||A-priori threshold p\<0.05 for 'subgroup 20-29.99%' vs 'baseline value before caffeine dose'.|Wilcoxon (Mann-Whitney)|||Comparison group is secondary outcome #4, baseline values before caffeine dose||||<0.0001
72418199|NCT03384173|144346722|OTHER|Mann Whitney U non-parametric t-test|||||<|0.05||||||A-priori threshold p\<0.05 for 'subgroup 20-29.99%' vs 'baseline value before caffeine dose'.|Wilcoxon (Mann-Whitney)|||Comparison group is Secondary Outcome #4, baseline before dose of caffeine.||||<0.05
72418200|NCT00863655|144346743|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.43|||<|0.0001|TWO_SIDED|95.0|0.35|0.54|||Log Rank|||||0.54|0.35|<0.0001
72610620|NCT03082729|144749903|SUPERIORITY|||||||0.088|||||||t-test, 2 sided|||||||0.088
72610621|NCT03082729|144749904|SUPERIORITY|||||||0.26|||||||t-test, 2 sided|||||||0.260
72610622|NCT03082729|144749904|SUPERIORITY|||||||0.526|||||||t-test, 2 sided|||||||0.526
72610623|NCT03082729|144749905|SUPERIORITY|||||||0.545|||||||t-test, 2 sided|||||||0.545
72610624|NCT03082729|144749905|SUPERIORITY|||||||0.69|||||||t-test, 2 sided|||||||0.690
72610625|NCT03082729|144749906|SUPERIORITY|||||||0.542|||||||t-test, 2 sided|||||||0.542
72610626|NCT03082729|144749906|SUPERIORITY|||||||0.344|||||||t-test, 2 sided|||||||0.344
72610627|NCT03082729|144749907|SUPERIORITY|||||||0.918|||||||t-test, 2 sided|||||||0.918
72610628|NCT03082729|144749907|SUPERIORITY|||||||0.035|||||||t-test, 2 sided|||||||0.035
72610629|NCT03082729|144749908|SUPERIORITY|||||||0.51|||||||t-test, 2 sided|||||||0.510
72610630|NCT03082729|144749908|SUPERIORITY|||||||0.516|||||||t-test, 2 sided|||||||0.516
72610631|NCT03082729|144749909|SUPERIORITY|||||||0.046|||||||t-test, 2 sided|||||||0.046
72610632|NCT03082729|144749909|SUPERIORITY|||||||0.088|||||||t-test, 2 sided|||||||0.088
72610633|NCT03082729|144749910|SUPERIORITY|||||||0.392|||||||t-test, 2 sided|||||||0.392
72610634|NCT03082729|144749910|SUPERIORITY|||||||0.177|||||||t-test, 2 sided|||||||0.177
72610635|NCT03082729|144749911|SUPERIORITY|||||||0.584|||||||t-test, 2 sided|||||||0.584
72610636|NCT03082729|144749911|SUPERIORITY|||||||0.065|||||||t-test, 2 sided|||||||0.065
72610637|NCT03082729|144749912|SUPERIORITY|||||||0.421|||||||t-test, 2 sided|||||||0.421
72610638|NCT03082729|144749912|SUPERIORITY|||||||0.145|||||||t-test, 2 sided|||||||0.145
72610639|NCT03082729|144749913|SUPERIORITY|||||||0.611|||||||t-test, 2 sided|||||||0.611
72610640|NCT03082729|144749913|SUPERIORITY|||||||0.345|||||||t-test, 2 sided|||||||0.345
72610641|NCT03082729|144749914|SUPERIORITY|||||||0.957|||||||t-test, 2 sided|||||||0.957
72610642|NCT03082729|144749914|SUPERIORITY|||||||0.425|||||||t-test, 2 sided|||||||0.425
72610643|NCT03082729|144749915|SUPERIORITY|||||||0.698|||||||t-test, 2 sided|||||||0.698
72610644|NCT03082729|144749915|SUPERIORITY|||||||0.709|||||||t-test, 2 sided|||||||0.709
72610645|NCT03082729|144749916|SUPERIORITY|||||||0.362|||||||t-test, 2 sided|||||||0.362
72610646|NCT03082729|144749916|SUPERIORITY|||||||0.221|||||||t-test, 2 sided|||||||0.221
72610647|NCT03082729|144749917|SUPERIORITY|||||||0.813|||||||t-test, 2 sided|||||||0.813
72610648|NCT03082729|144749917|SUPERIORITY|||||||0.046|||||||t-test, 2 sided|||||||0.046
72610649|NCT03082729|144749918|SUPERIORITY|||||||0.752|||||||t-test, 2 sided|||||||0.752
72610650|NCT03082729|144749918|SUPERIORITY|||||||0.808|||||||t-test, 2 sided|||||||0.808
72610651|NCT03082729|144749919|SUPERIORITY|||||||0.251|||||||t-test, 2 sided|||||||0.251
72610652|NCT03082729|144749919|SUPERIORITY|||||||0.329|||||||t-test, 2 sided|||||||0.329
72610653|NCT03082729|144749920|SUPERIORITY|||||||0.215|||||||t-test, 2 sided|||||||0.215
72610654|NCT03082729|144749920|SUPERIORITY|||||||0.612|||||||t-test, 2 sided|||||||0.612
72610655|NCT03082729|144749921|SUPERIORITY|||||||0.307|||||||t-test, 2 sided|||||||0.307
72610656|NCT03082729|144749921|SUPERIORITY|||||||0.686|||||||t-test, 2 sided|||||||0.686
72326221|NCT02722408|144175862|OTHER|||||||0.9276||||||Mixed-effects model for repeated measures analysis with percent change in VLDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84 (Defective LDLr)||||0.9276
72326222|NCT02722408|144175862|OTHER|||||||0.5821||||||Mixed-effects model for repeated measures analysis with percent change in VLDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28 (Met EAS Clinical Diagnosis of HoFH)||||0.5821
72326223|NCT02722408|144175862|OTHER|||||||0.8881||||||Mixed-effects model for repeated measures analysis with percent change in VLDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56 (Met EAS Clinical Diagnosis of HoFH)||||0.8881
72326224|NCT02722408|144175862|OTHER|||||||0.8525||||||Mixed-effects model for repeated measures analysis with percent change in VLDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84 (Met EAS Clinical Diagnosis of HoFH)||||0.8525
72326225|NCT02722408|144175862|OTHER|||||||0.0112||||||Mixed-effects model for repeated measures analysis with percent change in VLDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28 (Not Met EAS Clinical Diagnosis of HoFH)||||0.0112
72326226|NCT02722408|144175862|OTHER|||||||0.0018||||||Mixed-effects model for repeated measures analysis with percent change in VLDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56 (Not Met EAS Clinical Diagnosis of HoFH)||||0.0018
72326227|NCT02722408|144175862|OTHER|||||||0.0028||||||Mixed-effects model for repeated measures analysis with percent change in VLDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84 (Not Met EAS Clinical Diagnosis of HoFH).||||0.0028
72418201|NCT02157779|144346786|SUPERIORITY||Least Squares Mean Difference|-5.68||||0.017|TWO_SIDED|95.0|-10.32|-1.01||Threshold for statistical significance was 0.025.|ANCOVA|Method used: Hierarchical Linear Model (HLM) Repeated Measures Analysis of Covariance, Controlling for Baseline Score.|A negative difference means that the adjusted mean for CBI is numerically lower than that for SI.|All randomized participants with at least one post-baseline assessment (4wk, 8wk, end of treatment, 3 mo f/u, and/or 6 mo f/u) were used in the HLM analyses.||-1.01|-10.32|.017
72326228|NCT02722408|144175863|OTHER|||||||0.8985||||||Mixed-effects model for repeated measures analysis with change in VLDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28 (Negative LDLr)||||0.8985
72326229|NCT02722408|144175863|OTHER|||||||0.7664||||||Mixed-effects model for repeated measures analysis with change in VLDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56 (Negative LDLr)||||0.7664
72610657|NCT03082729|144749922|SUPERIORITY|||||||0.139|||||||t-test, 2 sided|||||||0.139
72610658|NCT03082729|144749922|SUPERIORITY|||||||0.35|||||||t-test, 2 sided|||||||0.350
72326230|NCT02722408|144175863|OTHER|||||||0.4755||||||Mixed-effects model for repeated measures analysis with change in VLDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84 (Negative LDLr)||||0.4755
72326231|NCT02722408|144175863|OTHER|||||||0.2286||||||Mixed-effects model for repeated measures analysis with change in VLDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28 (Defective LDLr)||||0.2286
72326232|NCT02722408|144175863|OTHER|||||||0.3975||||||Mixed-effects model for repeated measures analysis with change in VLDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56 (Defective LDLr)||||0.3975
72326233|NCT02722408|144175863|OTHER|||||||0.446||||||Mixed-effects model for repeated measures analysis with change in VLDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84 (Defective LDLr)||||0.4460
72326234|NCT02722408|144175863|OTHER|||||||0.9414||||||Mixed-effects model for repeated measures analysis with change in VLDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28 (Met EAS Clinical Diagnosis of HoFH)||||0.9414
72326235|NCT02722408|144175863|OTHER|||||||0.9735||||||Mixed-effects model for repeated measures analysis with change in VLDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56 (Met EAS Clinical Diagnosis of HoFH)||||0.9735
72326236|NCT02722408|144175863|OTHER|||||||0.9825||||||Mixed-effects model for repeated measures analysis with change in VLDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84 (Met EAS Clinical Diagnosis of HoFH)||||0.9825
72326237|NCT02722408|144175863|OTHER|||||||0.442||||||Mixed-effects model for repeated measures analysis with change in VLDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28 (Not Met EAS Clinical Diagnosis of HoFH)||||0.4420
72326238|NCT02722408|144175863|OTHER|||||||0.0378||||||Mixed-effects model for repeated measures analysis with change in VLDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56 (Not Met EAS Clinical Diagnosis of HoFH)||||0.0378
72610659|NCT03082729|144749923|SUPERIORITY|||||||0.721|||||||t-test, 2 sided|||||||0.721
72610660|NCT03082729|144749923|SUPERIORITY|||||||0.285|||||||t-test, 2 sided|||||||0.285
72610661|NCT03082729|144749924|SUPERIORITY|||||||0.804|||||||t-test, 2 sided|||||||0.804
72610662|NCT03082729|144749924|SUPERIORITY|||||||0.793|||||||t-test, 2 sided|||||||0.793
72610663|NCT03082729|144749925|SUPERIORITY|||||||0.293|||||||t-test, 2 sided|||||||0.293
72610664|NCT03082729|144749925|SUPERIORITY|||||||0.355|||||||t-test, 2 sided|||||||0.355
72610665|NCT03082729|144749926|SUPERIORITY|||||||0.101|||||||t-test, 2 sided|||||||0.101
72610666|NCT03082729|144749926|SUPERIORITY|||||||0.17|||||||t-test, 2 sided|||||||0.170
72610667|NCT03082729|144749927|SUPERIORITY|||||||0.137|||||||t-test, 2 sided|||||||0.137
72610668|NCT03082729|144749927|SUPERIORITY|||||||0.204|||||||t-test, 2 sided|||||||0.204
72610669|NCT03082729|144749928|SUPERIORITY|||||||0.115|||||||t-test, 2 sided|||||||0.115
72610670|NCT03082729|144749928|SUPERIORITY|||||||0.378|||||||t-test, 2 sided|||||||0.378
72610671|NCT03082729|144749929|SUPERIORITY|||||||0.122|||||||t-test, 2 sided|||||||0.122
72610672|NCT03082729|144749929|SUPERIORITY|||||||0.815|||||||t-test, 2 sided|||||||0.815
72610673|NCT03082729|144749930|SUPERIORITY|||||||0.321|||||||t-test, 2 sided|||||||0.321
72610674|NCT03082729|144749930|SUPERIORITY|||||||0.204|||||||t-test, 2 sided|||||||0.204
72610675|NCT03082729|144749931|SUPERIORITY|||||||0.352|||||||t-test, 2 sided|||||||0.352
72610676|NCT03082729|144749931|SUPERIORITY|||||||0.18|||||||t-test, 2 sided|||||||0.180
72610677|NCT03082729|144749932|SUPERIORITY|||||||0.094|||||||t-test, 2 sided|||||||0.094
72610678|NCT03082729|144749932|SUPERIORITY|||||||0.383|||||||t-test, 2 sided|||||||0.383
72610679|NCT03082729|144749933|SUPERIORITY|||||||0.024|||||||t-test, 2 sided|||||||0.024
72610680|NCT03082729|144749933|SUPERIORITY|||||||0.266|||||||t-test, 2 sided|||||||0.266
72610681|NCT03082729|144749934|SUPERIORITY|||||||0.042|||||||t-test, 2 sided|||||||0.042
72610682|NCT03082729|144749934|SUPERIORITY|||||||0.208|||||||t-test, 2 sided|||||||0.208
72610683|NCT03082729|144749935|SUPERIORITY|||||||0.446|||||||t-test, 2 sided|||||||0.446
72610684|NCT03082729|144749935|SUPERIORITY|||||||0.611|||||||t-test, 2 sided|||||||0.611
72610685|NCT03082729|144749936|SUPERIORITY|||||||0.014|||||||t-test, 2 sided|||||||0.014
72610686|NCT03082729|144749936|SUPERIORITY|||||||0.405|||||||t-test, 2 sided|||||||0.405
72610687|NCT02202252|144749998|SUPERIORITY_OR_OTHER|||||||0.49|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.490
72610688|NCT02202252|144749999|SUPERIORITY_OR_OTHER|||||||0.035|TWO_SIDED||||||Chi-squared|||||||0.035
72610689|NCT02202252|144750000|SUPERIORITY_OR_OTHER|||||||0.819|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.819
72610690|NCT04459338|144750004|SUPERIORITY|||||||0.02|||||||t-test, 2 sided|||All continuous data are summarized as means ± SEM. Area Under the Curve (AUC) was calculated using the trapezoidal rule. A paired, two-way Student t-test (parametric) or a Wilcoxon matched-pairs signed rank test (non-parametric) was used to examine differences between study days. A p-value \<0.05 was considered statistically significant.||||0.02
72610691|NCT03720119|144750040|OTHER|Analysis of Variance for repeated measurements.|day effect F|27.83||||0.0001|TWO_SIDED|||||The calculated P-Value represents the repeated measurement/Day (all times versus Day 1)|Dunnett's post-hoc test|||||||0.0001
72610692|NCT03743194|144750042|SUPERIORITY||Geometric mean ratio|0.98||||0.75|TWO_SIDED|95.0|0.85|1.13|||Linear mixed model|||A mixed effects linear model with repeated measures assuming an auto-regressive correlation structure was used to estimate the ratio of geometric means (treatment vs control). One patient from the control group whose measurements were all missing was conservatively imputed to have total OBAS of 2, 1, and 0 at postoperative Days 1, 2, and 3, respectively, assuming the best observed outcome for any control patient at that time. Total OBAS score was log transformed.||1.13|0.85|0.75
72610693|NCT03743194|144750042|SUPERIORITY||Geometric mean ratio|0.97||||0.71|TWO_SIDED|95.0|0.83|1.14|||linear mixed model|||A complete-case analysis (assumed that one patient was missing at random) was conducted as a sensitivity analysis. The ratio of geometric means (treatment vs control) was estimated using a mixed effects linear model with repeated measures assuming an auto-regressive AR(1) correlation structure.||1.14|0.83|0.71
72610694|NCT03743194|144750042|SUPERIORITY||Median Difference (Final Values)|0.08||||0.69|TWO_SIDED|95.0|-0.5|0.67|||Wilcoxon (Mann-Whitney)|||The total OBAS was averaged over 3 postoperative days for the sensitivity analysis. A Wilcoxon rank-sum test with Hodges-Lehmann estimation was used to estimate the median of differences (each OBAS in the treatment group was compared with each OBAS in the control group to calculate the difference)||0.67|-0.5|0.69
72610695|NCT03743194|144750043|SUPERIORITY|The ratio of geometric means was estimated through a generalized linear model with log transformed cumulative opioid consumption as the outcome and treatment group as the exposure. A multiple testing adjustment was applied (0.05/4 = 0.0125), thus 98.75% CI was provided.|Geometric mean ratio|1.01||||0.94|TWO_SIDED|98.75|0.73|1.4|||Regression, Linear|||||1.40|0.73|0.94
72610696|NCT03743194|144750044|SUPERIORITY|Difference in means at POD1|Mean Difference (Final Values)|0.08||||0.36|TWO_SIDED|99.6|-0.17|0.32|||Linear mixed model|||The difference in means was estimated through a mixed effects linear model with repeated measures assuming an auto-regressive correlation structure. Treatment effect was reported each day separately due to significant time-treatment interaction.||0.32|-0.17|0.36
72610697|NCT03743194|144750044|SUPERIORITY|Difference in mean at POD2|Mean Difference (Final Values)|-0.02||||0.79|TWO_SIDED|99.6|-0.26|0.22|||Linear mixed model|||The difference in means was estimated through a mixed effects linear model with repeated measures assuming an auto-regressive correlation structure. Treatment effect was reported each day separately due to significant time-treatment interaction.||0.22|-0.26|0.79
72610698|NCT03743194|144750044|SUPERIORITY|Difference in mean at POD3|Mean Difference (Final Values)|-0.07||||0.39|TWO_SIDED|99.6|-0.31|0.17|||Linear mixed model|||The difference in means was estimated through a mixed effects linear model with repeated measures assuming an auto-regressive correlation structure. Treatment effect was reported each day separately due to significant time-treatment interaction.||0.17|-0.31|0.39
72610699|NCT03743194|144750045|SUPERIORITY|Difference in mean in POD1|Mean Difference (Final Values)|0.07||||0.51|TWO_SIDED|99.6|-0.25|0.4|||Linear mixed model|||The difference in means was estimated through a mixed effects linear model with repeated measures assuming an auto-regressive correlation structure. Treatment effect was reported each day separately due to significant time-treatment interaction.||0.4|-0.25|0.51
72610700|NCT03743194|144750045|SUPERIORITY||Mean Difference (Final Values)|-0.01||||0.91|TWO_SIDED|99.6|-0.33|0.3||Mean difference at POD2|Linear mixed model|||The difference in means was estimated through a mixed effects linear model with repeated measures assuming an auto-regressive correlation structure. Treatment effect was reported each day separately due to significant time-treatment interaction.||0.30|-0.33|0.91
72326239|NCT02722408|144175863|OTHER|||||||0.0378||||||Mixed-effects model for repeated measures analysis with change in VLDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84 (Not Met EAS Clinical Diagnosis of HoFH)||||0.0378
72610701|NCT03743194|144750045|SUPERIORITY|Difference in mean at POD3|Mean Difference (Final Values)|-0.11||||0.31|TWO_SIDED|99.6|-0.43|0.21|||Linear mixed model|||The difference in means was estimated through a mixed effects linear model with repeated measures assuming an auto-regressive correlation structure. Treatment effect was reported each day separately due to significant time-treatment interaction.||0.21|-0.43|0.31
72610702|NCT03743194|144750046|SUPERIORITY|Difference in means at POD1|Mean Difference (Final Values)|0.22||||0.36|TWO_SIDED|99.6|-0.47|0.91|||Linear mixed model|||The difference in means was estimated through a mixed effects linear model with repeated measures assuming an auto-regressive correlation structure. Treatment effect was reported each day separately due to significant time-treatment interaction.||0.91|-0.47|0.36
72326240|NCT02722408|144175864|OTHER|||||||0.2305||||||Mixed-effects model for repeated measures analysis with percent change in HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28 (Negative LDLr)||||0.2305
72326241|NCT02722408|144175864|OTHER|||||||0.1836||||||Mixed-effects model for repeated measures analysis with percent change in HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56 (Negative LDLr)||||0.1836
72610703|NCT03743194|144750046|SUPERIORITY||Mean Difference (Final Values)|0.01||||0.97|TWO_SIDED|99.6|-0.66|0.67|||Linear mixed model|||The difference in means was estimated through a mixed effects linear model with repeated measures assuming an auto-regressive correlation structure. Treatment effect was reported each day separately due to significant time-treatment interaction.||0.67|-0.66|0.97
72610704|NCT03743194|144750046|SUPERIORITY|Difference in means at POD3|Mean Difference (Final Values)|-0.21||||0.36|TWO_SIDED|99.6|-0.88|0.46|||Linear mixed model|||The difference in means was estimated through a mixed effects linear model with repeated measures assuming an auto-regressive correlation structure. Treatment effect was reported each day separately due to significant time-treatment interaction.||0.46|-0.88|0.36
72326242|NCT02722408|144175864|OTHER|||||||0.6501||||||Mixed-effects model for repeated measures analysis with percent change in HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84 (Negative LDLr)||||0.6501
72418202|NCT02157779|144346787|SUPERIORITY||Least Squares Mean Difference|-0.14||||0.19|TWO_SIDED|95.0|-0.33|0.06||The threshold for statistical significance was p=0.025|ANCOVA|Hierarchical Linear Model (HLM) Repeated Measures Analysis of Covariance, Controlling for Baseline Score.||Population Description: All randomized participants with at least one post-baseline assessment (4wk, 8wk, end of treatment, 3 mo f/u, and/or 6 mo f/u) were used in the statistical analysis. Data were winsorized and log10 transformed to counter high levels of skewness. Full Information Maximum Likelihood was used to account for missing data.|A negative difference means that the adjusted mean for CBI is numerically lower than that for SI.|0.06|-0.33|0.19
72418203|NCT02157779|144346788|SUPERIORITY||Least Squares Mean Difference|-0.42||||0.011|TWO_SIDED|95.0|-0.75|-0.09||Threshold for statistical significance was 0.025.|ANCOVA|Hierarchical Linear Model (HLM) Repeated Measures Analysis of Covariance, Controlling for Baseline Score||Population Description: All randomized participants with at least one post-baseline assessment were used in the statistical analysis process.|A negative difference means that the adjusted mean for CBI is numerically lower than that for SI.|-0.09|-0.75|.011
72418204|NCT02157779|144346789|SUPERIORITY||Least Squares Mean Difference|-0.26||||0.16|TWO_SIDED|95.0|-0.63|0.11||Threshold for statistical significance was 0.025.|ANCOVA|Hierarchical Linear Model (HLM) Repeated Measures Analysis of Covariance, Controlling for Baseline Score.|A negative difference means that the adjusted mean for CBI is numerically lower than that for SI.|All randomized participants with at least one post-baseline assessment (12 weeks (end of treatment, 3 month and/or 6 month follow-up) were included in the analyses.||0.11|-0.63|0.16
72418205|NCT02157779|144346790|SUPERIORITY||Least Squares Mean Difference|-11.65||||0.031|TWO_SIDED|95.0|-22.2|-1.09||Threshold for statistical significance was 0.025.|ANCOVA|Hierarchical Linear Model (HLM) Repeated Measures Analysis of Covariance, Controlling for Baseline Score.|A negative difference means that the adjusted mean for CBI is numerically lower than that for SI.|All randomized participants with at least one post-baseline assessment (12 weeks (end of treatment), 3 month and/or 6 month follow-up) were included in the statistical analyses.||-1.09|-22.20|.031
72610705|NCT01944423|144750047|SUPERIORITY||Logit difference (final values)|0.64|STANDARD_ERROR_OF_MEAN|0.82|||TWO_SIDED|95.0|-2.25|0.97||p=ns 2-sided|two-phase growth curve model|||||0.97|-2.25|
72610706|NCT01944423|144750048|SUPERIORITY||Mean Difference (Final Values)|2.43|STANDARD_ERROR_OF_MEAN|1.87||0.038|TWO_SIDED|95.0|0.25|7.94||2-sided|two-phase growth curve model|||At end-of-treatment||7.94|0.25|.038
72326243|NCT02722408|144175864|OTHER|||||||0.0139||||||Mixed-effects model for repeated measures analysis with percent change in HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28 (Defective LDLr)||||0.0139
72418206|NCT02157779|144346791|SUPERIORITY||Least Squares Mean Difference|1.56||||0.004|TWO_SIDED|95.0|0.51|2.6||Threshold for statistical significance was 0.025.|ANCOVA|Hierarchical Linear Model (HLM) Repeated Measures Analysis of Covariance, Controlling for Baseline Score.||All randomized participants with at least one post-baseline assessment (week 12 (end of treatment), 3 month, and/or 6 month follow-up) were used in the statistical analysis.|A positive difference means that the adjusted mean for CBI is numerically higher than that for SI.|2.60|0.51|0.004
72610707|NCT01944423|144750049|SUPERIORITY||Mean Difference (Final Values)|3.21|STANDARD_ERROR_OF_MEAN|1.0||0.003|TWO_SIDED|95.0|1.15|5.26||2-sided|two-phase growth curve model|||At 6 month follow-up||5.26|1.15|.003
72610708|NCT02897349|144750050|SUPERIORITY||Adjusted Mean Difference (%)|-0.4|STANDARD_ERROR_OF_MEAN|0.13||0.0016|TWO_SIDED|95.0|-0.65|-0.16|||Mixed model repeated measures|||Based on Mixed-effect Model Repeated Measures (MMRM) including fixed effects treatment, week, type of insulin, and treatment by week interaction, linear covariates baseline HbA1c, baseline HbA1c by week interaction and random effect for patient. Within-patient errors are modelled by unstructured covariance matrix. Adjusted mean is based on all patients in the model (not only patients with a baseline and week 24 measurement).||-0.16|-0.65|0.0016
72610709|NCT02897349|144750051|SUPERIORITY||Adjusted Mean Difference (mg/dL)|-6.2|STANDARD_ERROR_OF_MEAN|5.1||0.2241|TWO_SIDED|95.0|-16.2|3.8|||Mixed model repeated measures|||Based on MMRM including fixed effects treatment, week, type of insulin, and treatment by week interaction, linear covariates baseline HbA1c, baseline FPG baseline FPG by week interaction and random effect for patient. Within-patient errors are modelled by unstructured covariance matrix. Adjusted mean is based on all patients in the model (not only patients with a baseline and week 24 measurement).||3.8|-16.2|0.2241
72610710|NCT02897349|144750052|SUPERIORITY||Adjusted Mean Difference (mg/dL)|-31.95|STANDARD_ERROR_OF_MEAN|8.2||0.0001|TWO_SIDED|95.0|-48.15|-15.75|||ANCOVA|||Based on analysis of covariance (ANCOVA) model including fixed effect treatment and type of insulin, and linear covariates baseline HbA1c and baseline 2-h PPG.||-15.75|-48.15|0.0001
72610711|NCT02897349|144750053|SUPERIORITY||Odds Ratio (OR)|1.793||||0.2431|TWO_SIDED|95.0|0.673|4.78|||Regression, Logistic|||Logistic regression model with terms for treatment and type of insulin as fixed effect and continuous linear covariates baseline HbA1c||4.780|0.673|0.2431
72326244|NCT02722408|144175864|OTHER|||||||0.0077||||||Mixed-effects model for repeated measures analysis with percent change in HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56 (Defective LDLr)||||0.0077
72418207|NCT02157779|144346792|SUPERIORITY||Least Squares Mean Difference|-2.15||||0.416|TWO_SIDED|95.0|-7.37|3.07||Threshold for statistical significance was 0.025.|ANCOVA|Hierarchical Linear Model (HLM) Repeated Measures Analysis of Covariance, Controlling for Baseline Score|A negative difference means that the adjusted mean for CBI is numerically lower than that for SI|All randomized participants with at least one post-baseline assessment were used in the statistical analysis process.||3.07|-7.37|0.416
72610712|NCT02897349|144750054|SUPERIORITY||Odds Ratio (OR)|1.481||||0.6235|TWO_SIDED|95.0|0.309|7.105|||Regression, Logistic|||Logistic regression model with terms for treatment and type of insulin as fixed effect and continuous linear covariates baseline HbA1c||7.105|0.309|0.6235
72610713|NCT02897349|144750055|SUPERIORITY||Odds Ratio (OR)|2.293||||0.0049|TWO_SIDED|95.0|1.286|4.091|||Regression, Logistic|||Logistic regression model with terms for treatment and type of insulin as fixed effect and continuous linear covariates baseline HbA1c||4.091|1.286|0.0049
72610714|NCT01829347|144750058|SUPERIORITY||Hazard Ratio (HR)|0.31||||0.076|TWO_SIDED|95.0|0.085|1.133|||Log Rank|||The primary endpoint was assessed using a Kaplan-Meier survival analysis of the Intent-to-Treat (ITT) population utilizing a log-rank test.||1.133|0.085|0.076
72610715|NCT01829347|144750059|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.000
72418208|NCT02157779|144346793|SUPERIORITY||Least Squares Mean Difference|-13.72||||0.028|TWO_SIDED|95.0|-25.94|-1.5||Threshold for significance was 0.025|ANCOVA|Hierarchical Linear Model (HLM) Repeated Measures Analysis of Covariance controlling for baseline score.|A negative difference means that the adjusted mean for CBI is numerically lower than that for SI.|All randomized participants with at least one post-baseline assessment were used in the analyses.||-1.50|-25.94|0.028
72610716|NCT01259245|144750132|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.017||||0.252|TWO_SIDED|95.0|-0.046|0.012||Regression coefficients from ANCOVA for Tai Chi intervention (PRP as reference) at 6 months after adjusted for baseline value of the outcome variable, age, sex, BMI, smoking and education|ANCOVA|||||0.012|-0.046|0.252
72610717|NCT01259245|144750133|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.005|STANDARD_DEVIATION|0.442||0.984|TWO_SIDED|95.0|-0.438|0.447|||ANCOVA|Adjusted for baseline values, age, sex, education, BMI and smoking||power0.80 for a medium effect size at 5% level of significance||0.447|-0.438|0.984
72610718|NCT01259245|144750134|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.372|STANDARD_DEVIATION|4.433||0.869|TWO_SIDED|95.0|-4.061|4.805|||ANCOVA|adjusted for baseline values, age, sex, education, BMI and education||power of 0.80 for a medium effect size at 5% level of significance||4.805|-4.061|0.869
72610719|NCT01259245|144750135|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.295|STANDARD_DEVIATION|4.706||0.588|TWO_SIDED|95.0|-6.001|3.411|||ANCOVA|adjusted for baseline values, age, sex, BMI, education and smoking||power of 0.80 for medium size effect at 5% level of significance||3.411|-6.001|0.588
72326245|NCT02722408|144175864|OTHER||||||<|0.0001||||||Mixed-effects model for repeated measures analysis with percent change in HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84 (Defective LDLr)||||<0.0001
72326246|NCT02722408|144175864|OTHER|||||||0.0507||||||Mixed-effects model for repeated measures analysis with percent change in HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28 (Met EAS Clinical Diagnosis of HoFH)||||0.0507
72418209|NCT02157779|144346794|SUPERIORITY|||||||0.13|||||||ANOVA|GLM Repeated Measures Analysis of Variance of means grouped by sessions 1-4, 5-8, and 9-12||All randomized participants with at least one DAR completed in each time frame (sessions 1-4, 5-8, and 9-12) were included in the analyses. The mean DAR scores for sessions 1-4, 5-8, and 9-12 were calculated and used as outcome variables in the GLM repeated measures ANOVA.||||0.13
72418210|NCT02157779|144346795|SUPERIORITY||Least Squares Mean Difference|-0.82||||0.03|TWO_SIDED|95.0|-1.578|-0.063||Threshold for statistical significance was 0.025.|ANCOVA|Hierarchical Linear Model (HLM) Repeated Measures Analysis of Covariance, Controlling for Baseline Score|A negative difference means that the adjusted mean for CBI is numerically lower than that for SI.|All randomized participants with at least one post-baseline assessment (week 4, week 8, week 12 (end of treatment), 3 mo and/or 6 month follow-up) were included in the HLM analyses.||-0.063|-1.578|0.030
72418211|NCT02157779|144346796|SUPERIORITY||Least Squares Mean Difference|-0.085||||0.021|TWO_SIDED|95.0|-0.158|-0.011||Threshold for statistical significance was 0.025.|ANCOVA|Hierarchical Linear Model (HLM) Repeated Measures Analysis of Covariance, Controlling for Baseline Score|A negative difference means that the adjusted mean for CBI is numerically lower than that for SI.|"All randomized participants with at least one post-baseline assessment (4 week, 8 week, 12 week, 3 month and/or 6 month follow-up) were included in the HLM analysis.~Data were winsorized and log10 transformed to counter high levels of skewness. Full Information Maximum Likelihood was used to account for missing data."||-0.011|-0.158|0.021
72610720|NCT01259245|144750136|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.15|STANDARD_DEVIATION|4.477||0.345|TWO_SIDED|95.0|-6.627|2.327|||ANCOVA|adjusted for baseline values, age, sex, BMI, education and smoking||power of 0.80 for medium effect size at 5% level of significance||2.327|-6.627|0.345
72610721|NCT01259245|144750137|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.69|STANDARD_DEVIATION|4.062||0.413|TWO_SIDED|95.0|-5.753|2.372|||ANCOVA|adjusted for baseline value, age, sex, BMI, education and smoking||power of 0.80 for medium effect size at 5% level of significance||2.372|-5.753|0.413
72610722|NCT01259245|144750138|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.049|STANDARD_DEVIATION|8.89||0.004|TWO_SIDED|95.0|4.159|21.939|||ANCOVA|adjusted for baseline value, age, sex, BMI, education and smoking||power of 0.80 for medium effect size at 5% level of significance||21.939|4.159|0.004
72610723|NCT01259245|144750139|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.042|STANDARD_DEVIATION|0.226||0.56|TWO_SIDED|95.0|-0.1|0.184|||ANCOVA|adjusted for baseline value, age, sex, BMI, education and smoking||power of 0.80 for medium effect size at 5% level of significance||0.184|-0.100|0.560
72610724|NCT01259245|144750140|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.037|STANDARD_DEVIATION|0.088||0.425|TWO_SIDED|95.0|-0.054|0.128|||ANCOVA|adjusted for baseline value, age, sex, BMI, education and smoking||power of 0.80 for medium effect size at 5% level of significance||0.128|-0.054|0.425
72610725|NCT01259245|144750141|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.6|STANDARD_DEVIATION|5.2||0.528|TWO_SIDED|95.0|-3.5|6.8|||ANCOVA|adjusted for baseline value, age, sex, BMI, education and smoking||power of 0.80 for medium effect size at 5% level of significance||6.8|-3.5|0.528
72610726|NCT02065557|144750153|SUPERIORITY|one-sample two-sided Chi-square test|||||<|0.001||||||Adjusted p-value from a sequentially rejective multiple test procedure, testing co-primary and ranked secondary endpoints 1st for I-SD+I-HD, then for individual adalimumab dose groups (I-HD, I-SD) against the respective external placebo rate (19.83%)|rejective multiple test procedure|controlling familywise Type I error of 5% in a strong sense||Efficacy analysis was based on the Intent-To-Treat-Efficacy (ITT-E) population for the induction period. The ITT-E population was a subpopulation of the ITT population, which consisted of all participants who received at least one SC injection of the study medication during the induction period. Participants who received open-label high induction dose, because they enrolled after Protocol Amendment 4 was released, were excluded from the ITT-E population.||||< 0.001
72610727|NCT02065557|144750153|SUPERIORITY|one-sample two-sided Chi-square test|||||<|0.001||||||Adjusted p-value from a sequentially rejective multiple test procedure, testing co-primary and ranked secondary endpoints 1st for I-SD+I-HD, then for individual adalimumab dose groups (I-HD, I-SD) against the respective external placebo rate (19.83%)|rejective multiple test procedure|controlling familywise Type I error of 5% in a strong sense||Efficacy analysis was based on the Intent-To-Treat-Efficacy (ITT-E) population for the induction period. The ITT-E population was a subpopulation of the ITT population, which consisted of all participants who received at least one SC injection of the study medication during the induction period. Participants who received open-label high induction dose, because they enrolled after Protocol Amendment 4 was released, were excluded from the ITT-E population.||||< 0.001
72610728|NCT02065557|144750153|SUPERIORITY|one-sample two-sided Chi-square test||||||0.382||||||Adjusted p-value from a sequentially rejective multiple test procedure, testing co-primary and ranked secondary endpoints 1st for I-SD+I-HD, then for individual adalimumab dose groups (I-HD, I-SD) against the respective external placebo rate (19.83%)|rejective multiple test procedure|controlling familywise Type I error of 5% in a strong sense||Efficacy analysis was based on the Intent-To-Treat-Efficacy (ITT-E) population for the induction period. The ITT-E population was a subpopulation of the ITT population, which consisted of all participants who received at least one SC injection of the study medication during the induction period. Participants who received open-label high induction dose, because they enrolled after Protocol Amendment 4 was released, were excluded from the ITT-E population.||||0.382
72610729|NCT02065557|144750153|SUPERIORITY|one-sample two-sided Chi-square test|||||<|0.001||||||Adjusted p-value from a sequentially rejective multiple test procedure, testing co-primary and ranked secondary endpoints 1st for I-SD+I-HD, then for individual adalimumab dose groups (I-HD, I-SD) against the respective external placebo rate (19.83%)|rejective multiple test procedure|controlling familywise Type I error of 5% in a strong sense||Efficacy analysis was based on the Intent-To-Treat-Efficacy (ITT-E) population for the induction period. The ITT-E population was a subpopulation of the ITT population, which consisted of all participants who received at least one SC injection of the study medication during the induction period. Participants who received open-label high induction dose, because they enrolled after Protocol Amendment 4 was released, were excluded from the ITT-E population.||||< 0.001
72610730|NCT02065557|144750153|SUPERIORITY|one-sample two-sided Chi-square test|||||<|0.001||||||Adjusted p-value from a sequentially rejective multiple test procedure, testing co-primary and ranked secondary endpoints 1st for I-SD+I-HD, then for individual adalimumab dose groups (I-HD, I-SD) against the respective external placebo rate (19.83%)|rejective multiple test procedure|controlling familywise Type I error of 5% in a strong sense||Efficacy analysis was based on the Intent-To-Treat-Efficacy (ITT-E) population for the induction period. The ITT-E population was a subpopulation of the ITT population, which consisted of all participants who received at least one SC injection of the study medication during the induction period. Participants who received open-label high induction dose, because they enrolled after Protocol Amendment 4 was released, were excluded from the ITT-E population.||||< 0.001
72610731|NCT02065557|144750153|SUPERIORITY|one-sample two-sided Chi-square test||||||0.344||||||Adjusted p-value from a sequentially rejective multiple test procedure, testing co-primary and ranked secondary endpoints 1st for I-SD+I-HD, then for individual adalimumab dose groups (I-HD, I-SD) against the respective external placebo rate (19.83%)|rejective multiple test procedure|controlling familywise Type I error of 5% in a strong sense||Efficacy analysis was based on the Intent-To-Treat-Efficacy (ITT-E) population for the induction period. The ITT-E population was a subpopulation of the ITT population, which consisted of all participants who received at least one SC injection of the study medication during the induction period. Participants who received open-label high induction dose, because they enrolled after Protocol Amendment 4 was released, were excluded from the ITT-E population.||||0.344
72610732|NCT02065557|144750154|SUPERIORITY|one-sample two-sided Chi-square test|||||<|0.001||||||Adjusted p-value from a sequentially rejective multiple test procedure, testing co-primary and ranked secondary endpoints 1st for M-SD+M-HD, then for individual adalimumab dose groups (M-HD, M-SD) against the respective external placebo rate (18.37%)|rejective multiple test procedure|controlling familywise Type I error of 5% in a strong sense||Efficacy analysis was based on the modified Intent-To-Treat-Efficacy (mITT-E) population for the maintenance period. The mITT-E population was a subpopulation of the mITT population, where participants in M-PL arm were excluded.||||< 0.001
72610733|NCT02065557|144750154|SUPERIORITY|one-sample two-sided Chi-square test|||||<|0.001||||||Adjusted p-value from a sequentially rejective multiple test procedure, testing co-primary and ranked secondary endpoints 1st for M-SD+M-HD, then for individual adalimumab dose groups (M-HD, M-SD) against the respective external placebo rate (18.37%)|rejective multiple test procedure|controlling familywise Type I error of 5% in a strong sense||Efficacy analysis was based on the modified Intent-To-Treat-Efficacy (mITT-E) population for the maintenance period. The mITT-E population was a subpopulation of the mITT population, where participants in M-PL arm were excluded.||||< 0.001
72610734|NCT02065557|144750154|SUPERIORITY|one-sample two-sided Chi-square test||||||0.382||||||Adjusted p-value from a sequentially rejective multiple test procedure, testing co-primary and ranked secondary endpoints 1st for M-SD+M-HD, then for individual adalimumab dose groups (M-HD, M-SD) against the respective external placebo rate (18.37%)|rejective multiple test procedure|controlling familywise Type I error of 5% in a strong sense||Efficacy analysis was based on the modified Intent-To-Treat-Efficacy (mITT-E) population for the maintenance period. The mITT-E population was a subpopulation of the mITT population, where participants in M-PL arm were excluded.||||0.382
72418212|NCT02157779|144346797|SUPERIORITY||Least Squares Mean Difference|-0.1||||0.246|TWO_SIDED|95.0|-0.283|0.073||Threshold for significance was 0.025|ANCOVA|Hierarchical Linear Model (HLM) Repeated Measures Analysis of Covariance, Controlling for Baseline Score.|A negative difference means that the adjusted mean for CBI is numerically lower than that for SI.|All randomized participants with at least one post-baseline assessment (4 week, 8 week, 12 week, 3 month and/or 6 month follow-up) were used in the HLM analysis. Data were winsorized and log10 transformed to counter high levels of skewness. Full Information Maximum Likelihood was used to account for missing data.||0.073|-0.283|0.246
72418213|NCT02157779|144346798|SUPERIORITY||Least Squares Mean Difference|-0.14||||0.036|TWO_SIDED|95.0|-0.27|-0.01||Threshold for statistical significance was 0.025.|ANCOVA|Hierarchical Linear Model (HLM) Repeated Measures Analysis of Covariance, Controlling for Baseline Score|A negative difference means that the adjusted mean for CBI is numerically lower than that for SI.|All randomized participants with at least one post-baseline assessment were used in the statistical analysis. Data were winsorized and log 10 transformed to counter high levels of skewness.||-0.01|-0.27|0.036
72418214|NCT02157779|144346799|SUPERIORITY||Least Squares Mean Difference|-0.026||||0.786|TWO_SIDED|95.0|-0.213|0.1614||Threshold for statistical significance was 0.025|ANCOVA|Hierarchical Linear Model (HLM) Repeated Measures Analysis of Covariance, controlling for baseline score.|A negative difference means that the adjusted mean for CBI is numerically lower than that for SI.|"All randomized participants with at least one post-baseline assessment (4 week, 8 week, 12 week, 3 month and/or 6 month follow-up) were included in the HLM analysis.~Data were winsorized and log10 transformed to counter high levels of skewness. Full Information Maximum Likelihood was used to account for missing data."||0.1614|-0.213|0.786
72418215|NCT02157779|144346800|SUPERIORITY||Least Squares Mean Difference|-0.02||||0.744|TWO_SIDED|95.0|-0.18|0.13||Threshold for significance was 0.025.|ANCOVA|Hierarchical Linear Model (HLM) Repeated Measures Analysis of Covariance, controlling for baseline score.|A negative difference means that the adjusted mean for CBI is numerically lower than that for SI.|"All randomized participants with at least one post-baseline assessment (4 week, 8 week, 12 week, 3 month and/or 6 month follow-up) were included in the HLM analysis.~Data were winsorized and log10 transformed to counter high levels of skewness. Full Information Maximum Likelihood was used to account for missing data."||0.13|-0.18|0.744
72610735|NCT02065557|144750154|SUPERIORITY|one-sample two-sided Chi-square test|||||<|0.001||||||Adjusted p-value from a sequentially rejective multiple test procedure, testing co-primary and ranked secondary endpoints 1st for M-SD+M-HD, then for individual adalimumab dose groups (M-HD, M-SD) against the respective external placebo rate (18.37%)|rejective multiple test procedure|controlling familywise Type I error of 5% in a strong sense||Efficacy analysis was based on the modified Intent-To-Treat-Efficacy (mITT-E) population for the maintenance period. The mITT-E population was a subpopulation of the mITT population, where participants in M-PL arm were excluded.||||< 0.001
72418216|NCT02157779|144346801|SUPERIORITY||Least Squares Mean Difference|-1.85||||0.002|TWO_SIDED|95.0|-3.038|-0.663||Threshold for significance was 0.025|ANCOVA|Hierarchical Linear Model (HLM) Repeated Measures Analysis of Covariance, controlling for baseline score.|A negative difference means that the adjusted mean for CBI is numerically lower than that for SI.|All randomized participants with at least one post-baseline assessment (4 week, 8 week, 12 week, 3 month and/or 6 month follow-up) were included in the HLM analysis. Full Information Maximum Likelihood was used to account for missing data.||-0.663|-3.038|0.002
72418217|NCT02157779|144346802|SUPERIORITY||Least Squares Mean Difference|-1.0||||0.186|TWO_SIDED|95.0|-2.518|0.524||Threshold for significance was 0.025|ANCOVA|Hierarchical Linear Model (HLM) Repeated Measures Analysis of Covariance, controlling for baseline score.|A negative difference means that the adjusted mean for CBI is numerically lower than that for SI.|All randomized participants with at least one post-baseline assessment (4wk, 8wk, 12 week (end of treatment), 3 mo and/or 6 mo follow-up) were included in the HLM analysis. Full Information Maximum Likelihood was used to account for missing data.||0.524|-2.518|0.186
72418218|NCT02157779|144346803|SUPERIORITY||Least Squares Mean Difference|1.26||||0.164|TWO_SIDED|95.0|-0.56|3.09||Threshold for significance was 0.025|ANCOVA|Hierarchical Linear Model (HLM) Repeated Measures Analysis of Covariance, controlling for baseline score.|A positive difference means that the adjusted mean for CBI is numerically higher than that for SI.|"All randomized participants with at least one post-baseline assessment (4wk, 8wk, 12 week (end of treatment), 3 mo and/or 6 mo follow-up) were included in the HLM analysis.~Full Information Maximum Likelihood was used to account for missing data."||3.09|-0.560|0.164
72418219|NCT02157779|144346804|SUPERIORITY||Least Squares Mean Difference|1.33||||0.1|TWO_SIDED|95.0|-0.26|2.92||Threshold for statistical significance was 0.025.|ANCOVA|Hierarchical Linear Model (HLM) Repeated Measures Analysis of Covariance, Controlling for Baseline Score|A positive difference means that the adjusted mean for CBI is numerically higher than that for SI.|"All randomized participants with at least one post-baseline assessment (4wk, 8wk, 12 week (end of treatment), 3 mo and/or 6 mo follow-up) were included in the HLM analysis.~Full Information Maximum Likelihood was used to account for missing data."||2.92|-0.26|0.100
72418220|NCT02157779|144346805|SUPERIORITY||Least Squares Mean Difference|-6.29||||0.06|TWO_SIDED|95.0|-12.85|0.27||Threshold for significance was 0.025|ANCOVA|Hierarchical Linear Model (HLM) Repeated Measures Analysis of Covariance, controlling for baseline score.||"All randomized participants with at least one post-baseline assessment (12 week (end of treatment), 3 mo and/or 6 mo follow-up) were included in the HLM analysis.~Full Information Maximum Likelihood was used to account for missing data."|A negative difference means that the adjusted mean for CBI is numerically lower than that for SI, indicating less symptomatic distress.|0.27|-12.85|0.060
72326247|NCT02722408|144175864|OTHER|||||||0.0118||||||Mixed-effects model for repeated measures analysis with percent change in HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56 (Met EAS Clinical Diagnosis of HoFH)||||0.0118
72418221|NCT02157779|144346806|SUPERIORITY||Least Squares Mean Difference|-3.271||||0.023|TWO_SIDED|95.0|-6.083|-0.458||Threshold for significance was 0.025|ANCOVA|Hierarchical Linear Model (HLM) Repeated Measures Analysis of Covariance, controlling for baseline score.|A negative difference means that the adjusted mean for CBI is numerically lower than that for SI.|"All randomized participants with at least one post-baseline assessment (12 week (end of treatment), 3 mo and/or 6 mo follow-up) were included in the HLM analysis.~Full Information Maximum Likelihood was used to account for missing data."||-0.458|-6.083|0.023
72418222|NCT02157779|144346807|SUPERIORITY||Least Squares Mean Difference|-1.28||||0.23|TWO_SIDED|95.0|-3.39|0.82||Threshold for significance was 0.025|ANCOVA|Hierarchical Linear Model (HLM) Repeated Measures Analysis of Covariance, controlling for baseline score.|A negative difference means that the adjusted mean for CBI is numerically lower than that for SI.|"All randomized participants with at least one post-baseline assessment (12 week (end of treatment), 3 mo and/or 6 mo follow-up) were included in the HLM analysis.~Full Information Maximum Likelihood was used to account for missing data."||0.82|-3.39|0.23
72610736|NCT02065557|144750154|SUPERIORITY|one-sample two-sided Chi-square test|||||<|0.001||||||Adjusted p-value from a sequentially rejective multiple test procedure, testing co-primary and ranked secondary endpoints 1st for M-SD+M-HD, then for individual adalimumab dose groups (M-HD, M-SD) against the respective external placebo rate (18.37%)|rejective multiple test procedure|controlling familywise Type I error of 5% in a strong sense||Efficacy analysis was based on the modified Intent-To-Treat-Efficacy (mITT-E) population for the maintenance period. The mITT-E population was a subpopulation of the mITT population, where participants in M-PL arm were excluded.||||< 0.001
72610737|NCT02065557|144750154|SUPERIORITY|one-sample two-sided Chi-square test||||||0.344||||||Adjusted p-value from a sequentially rejective multiple test procedure, testing co-primary and ranked secondary endpoints 1st for M-SD+M-HD, then for individual adalimumab dose groups (M-HD, M-SD) against the respective external placebo rate (18.37%)|rejective multiple test procedure|controlling familywise Type I error of 5% in a strong sense||Efficacy analysis was based on the modified Intent-To-Treat-Efficacy (mITT-E) population for the maintenance period. The mITT-E population was a subpopulation of the mITT population, where participants in M-PL arm were excluded.||||0.344
72610738|NCT02065557|144750155|SUPERIORITY|one-sample two-sided Chi-square test|||||<|0.001||||||Adjusted p-value from a sequentially rejective multiple test procedure, testing co-primary and ranked secondary endpoints 1st for M-SD+M-HD, then for individual adalimumab dose groups (M-HD, M-SD) against the respective external placebo rate (26.10%)|rejective multiple test procedure|controlling familywise Type I error of 5% in a strong sense||Efficacy analysis was based on the modified Intent-To-Treat-Efficacy (mITT-E) population for the maintenance period. The mITT-E population was a subpopulation of the mITT population, where participants in M-PL arm were excluded.||||< 0.001
72610739|NCT02065557|144750155|SUPERIORITY|one-sample two-sided Chi-square test|||||<|0.001||||||Adjusted p-value from a sequentially rejective multiple test procedure, testing co-primary and ranked secondary endpoints 1st for M-SD+M-HD, then for individual adalimumab dose groups (M-HD, M-SD) against the respective external placebo rate (26.10%)|Chi-squared|controlling familywise Type I error of 5% in a strong sense||Efficacy analysis was based on the modified Intent-To-Treat-Efficacy (mITT-E) population for the maintenance period. The mITT-E population was a subpopulation of the mITT population, where participants in M-PL arm were excluded.||||< 0.001
72610740|NCT02065557|144750155|SUPERIORITY|one-sample two-sided Chi-square test||||||0.008||||||Adjusted p-value from a sequentially rejective multiple test procedure, testing co-primary and ranked secondary endpoints 1st for M-SD+M-HD, then for individual adalimumab dose groups (M-HD, M-SD) against the respective external placebo rate (26.10%)|Chi-squared|controlling familywise Type I error of 5% in a strong sense||Efficacy analysis was based on the modified Intent-To-Treat-Efficacy (mITT-E) population for the maintenance period. The mITT-E population was a subpopulation of the mITT population, where participants in M-PL arm were excluded.||||0.008
72610741|NCT02065557|144750155|SUPERIORITY|one-sample two-sided Chi-square test|||||<|0.001||||||Adjusted p-value from a sequentially rejective multiple test procedure, testing co-primary and ranked secondary endpoints 1st for M-SD+M-HD, then for individual adalimumab dose groups (M-HD, M-SD) against the respective external placebo rate (26.10%)|rejective multiple test procedure|controlling familywise Type I error of 5% in a strong sense||Efficacy analysis was based on the modified Intent-To-Treat-Efficacy (mITT-E) population for the maintenance period. The mITT-E population was a subpopulation of the mITT population, where participants in M-PL arm were excluded.||||< 0.001
72610742|NCT02065557|144750155|SUPERIORITY|one-sample two-sided Chi-square test|||||<|0.001||||||Adjusted p-value from a sequentially rejective multiple test procedure, testing co-primary and ranked secondary endpoints 1st for M-SD+M-HD, then for individual adalimumab dose groups (M-HD, M-SD) against the respective external placebo rate (26.10%)|rejective multiple test procedure|controlling familywise Type I error of 5% in a strong sense||Efficacy analysis was based on the modified Intent-To-Treat-Efficacy (mITT-E) population for the maintenance period. The mITT-E population was a subpopulation of the mITT population, where participants in M-PL arm were excluded.||||< 0.001
72610743|NCT02065557|144750155|SUPERIORITY|one-sample two-sided Chi-square test||||||0.038||||||Adjusted p-value from a sequentially rejective multiple test procedure, testing co-primary and ranked secondary endpoints 1st for M-SD+M-HD, then for individual adalimumab dose groups (M-HD, M-SD) against the respective external placebo rate (26.10%)|rejective multiple test procedure|controlling familywise Type I error of 5% in a strong sense||Efficacy analysis was based on the modified Intent-To-Treat-Efficacy (mITT-E) population for the maintenance period. The mITT-E population was a subpopulation of the mITT population, where participants in M-PL arm were excluded.||||0.038
72610744|NCT02065557|144750156|SUPERIORITY|one-sample two-sided Chi-square test|||||<|0.001||||||Adjusted p-value from a sequentially rejective multiple test procedure, testing co-primary and ranked secondary endpoints 1st for M-SD+M-HD, then for individual adalimumab dose groups (M-HD, M-SD) against the respective external placebo rate (22.03%)|rejective multiple test procedure|controlling familywise Type I error of 5% in a strong sense||Efficacy analysis was based on the modified Intent-To-Treat-Efficacy (mITT-E) population for the maintenance period. The mITT-E population was a subpopulation of the mITT population, where participants in M-PL arm were excluded.||||< 0.001
72610745|NCT02065557|144750156|SUPERIORITY|one-sample two-sided Chi-square test|||||<|0.001||||||Adjusted p-value from a sequentially rejective multiple test procedure, testing co-primary and ranked secondary endpoints 1st for M-SD+M-HD, then for individual adalimumab dose groups (M-HD, M-SD) against the respective external placebo rate (22.03%)|rejective multiple test procedure|controlling familywise Type I error of 5% in a strong sense||Efficacy analysis was based on the modified Intent-To-Treat-Efficacy (mITT-E) population for the maintenance period. The mITT-E population was a subpopulation of the mITT population, where participants in M-PL arm were excluded.||||< 0.001
72326248|NCT02722408|144175864|OTHER|||||||0.0122||||||Mixed-effects model for repeated measures analysis with percent change in HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84 (Met EAS Clinical Diagnosis of HoFH)||||0.0122
72326249|NCT02722408|144175864|OTHER|||||||0.0077||||||Mixed-effects model for repeated measures analysis with percent change in HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28 (Not Met EAS Clinical Diagnosis of HoFH)||||0.0077
72326250|NCT02722408|144175864|OTHER|||||||0.0317||||||Mixed-effects model for repeated measures analysis with percent change in HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56 (Not Met EAS Clinical Diagnosis of HoFH)||||0.0317
72326251|NCT02722408|144175864|OTHER|||||||0.0473||||||Mixed-effects model for repeated measures analysis with percent change in HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84 (Not Met EAS Clinical Diagnosis of HoFH).||||0.0473
72326252|NCT02722408|144175865|OTHER|||||||0.2143||||||Mixed-effects model for repeated measures analysis with change in HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28 (Negative LDLr)||||0.2143
72418223|NCT02249819|144346811|EQUIVALENCE|Statistical analysis for mean change from baseline in naming accuracy in the anodal vs. sham tDCS conditions Null hypothesis is that there was no difference in mean change of naming accuracy between anodal and sham tDCS conditions. A significance level of 0.05 was used (two-sided).||||||0.694||||||The wilcoxon sign-ranked test was performed for this crossover design study in which subjects underwent measures across 2 study conditions (paired samples: mean change in anodal vs. sham condition). A significance level of 0.05 was used (two-sided).|wilcoxon sign-ranked test|Western Aphasia Battery used as a screening tool on admission only, to characterize level of severity. It was NOT an outcome measure.||||||0.694
72418224|NCT00831779|144346831|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|19.97|STANDARD_ERROR_OF_MEAN|7.4685||0.0059|TWO_SIDED|95.0|5.75|36.1||Primary endpoint was tested at alpha=0.05|ANOVA|||||36.10|5.75|0.0059
72418225|NCT00831779|144346832|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|28.13|STANDARD_ERROR_OF_MEAN|14.4984||0.0598|TWO_SIDED|95.0|-1.22|57.48||Secondary endpoint was tested following a sequential testing procedure at alpha=0.05|ANOVA|||||57.48|-1.22|0.0598
72326253|NCT02722408|144175865|OTHER|||||||0.1874||||||Mixed-effects model for repeated measures analysis with change in HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56 (Negative LDLr)||||0.1874
72326254|NCT02722408|144175865|OTHER|||||||0.6731||||||Mixed-effects model for repeated measures analysis with change in HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84 (Negative LDLr)||||0.6731
72326255|NCT02722408|144175865|OTHER|||||||0.0027||||||Mixed-effects model for repeated measures analysis with change in HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28 (Defective LDLr)||||0.0027
72326256|NCT02722408|144175865|OTHER|||||||0.002||||||Mixed-effects model for repeated measures analysis with change in HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28 (Defective LDLr)||||0.0020
72326257|NCT02722408|144175865|OTHER||||||<|0.0001||||||Mixed-effects model for repeated measures analysis with change in HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84 (Defective LDLr)||||<0.0001
72326258|NCT02722408|144175865|OTHER|||||||0.0258||||||Mixed-effects model for repeated measures analysis with change in HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28 (Met EAS Clinical Diagnosis of HoFH)||||0.0258
72326259|NCT02722408|144175865|OTHER|||||||0.0044||||||Mixed-effects model for repeated measures analysis with change in HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56 (Met EAS Clinical Diagnosis of HoFH)||||0.0044
72610746|NCT02065557|144750156|SUPERIORITY|one-sample two-sided Chi-square test||||||0.382||||||Adjusted p-value from a sequentially rejective multiple test procedure, testing co-primary and ranked secondary endpoints 1st for M-SD+M-HD, then for individual adalimumab dose groups (M-HD, M-SD) against the respective external placebo rate (22.03%)|rejective multiple test procedure|controlling familywise Type I error of 5% in a strong sense||Efficacy analysis was based on the modified Intent-To-Treat-Efficacy (mITT-E) population for the maintenance period. The mITT-E population was a subpopulation of the mITT population, where participants in M-PL arm were excluded.||||0.382
72610747|NCT02065557|144750156|SUPERIORITY|one-sample two-sided Chi-square test|||||<|0.001||||||Adjusted p-value from a sequentially rejective multiple test procedure, testing co-primary and ranked secondary endpoints 1st for M-SD+M-HD, then for individual adalimumab dose groups (M-HD, M-SD) against the respective external placebo rate (22.03%)|rejective multiple test procedure|controlling familywise Type I error of 5% in a strong sense||Efficacy analysis was based on the modified Intent-To-Treat-Efficacy (mITT-E) population for the maintenance period. The mITT-E population was a subpopulation of the mITT population, where participants in M-PL arm were excluded.||||< 0.001
72610748|NCT02065557|144750156|SUPERIORITY|one-sample two-sided Chi-square test|||||<|0.001||||||Adjusted p-value from a sequentially rejective multiple test procedure, testing co-primary and ranked secondary endpoints 1st for M-SD+M-HD, then for individual adalimumab dose groups (M-HD, M-SD) against the respective external placebo rate (22.03%)|rejective multiple test procedure|controlling familywise Type I error of 5% in a strong sense||Efficacy analysis was based on the modified Intent-To-Treat-Efficacy (mITT-E) population for the maintenance period. The mITT-E population was a subpopulation of the mITT population, where participants in M-PL arm were excluded.||||< 0.001
72610749|NCT02065557|144750156|SUPERIORITY|one-sample two-sided Chi-square test||||||0.344||||||Adjusted p-value from a sequentially rejective multiple test procedure, testing co-primary and ranked secondary endpoints 1st for M-SD+M-HD, then for individual adalimumab dose groups (M-HD, M-SD) against the respective external placebo rate (22.03%)|rejective multiple test procedure|controlling familywise Type I error of 5% in a strong sense||Efficacy analysis was based on the modified Intent-To-Treat-Efficacy (mITT-E) population for the maintenance period. The mITT-E population was a subpopulation of the mITT population, where participants in M-PL arm were excluded.||||0.344
72610750|NCT02065557|144750157|SUPERIORITY|one-sample two-sided Chi-square test|||||<|0.001||||||Adjusted p-value from a sequentially rejective multiple test procedure, testing co-primary and ranked secondary endpoints 1st for M-SD+M-HD, then for individual adalimumab dose groups (M-HD, M-SD) against the respective external placebo rate (14.79%)|rejective multiple test procedure|controlling familywise Type I error of 5% in a strong sense||Efficacy analysis was based on the modified Intent-To-Treat-Efficacy (mITT-E) population for the maintenance period. The mITT-E population was a subpopulation of the mITT population, where participants in M-PL arm were excluded.||||< 0.001
72610751|NCT02065557|144750157|SUPERIORITY|one-sample two-sided Chi-square test|||||<|0.001||||||Adjusted p-value from a sequentially rejective multiple test procedure, testing co-primary and ranked secondary endpoints 1st for M-SD+M-HD, then for individual adalimumab dose groups (M-HD, M-SD) against the respective external placebo rate (14.79%)|rejective multiple test procedure|controlling familywise Type I error of 5% in a strong sense||Efficacy analysis was based on the modified Intent-To-Treat-Efficacy (mITT-E) population for the maintenance period. The mITT-E population was a subpopulation of the mITT population, where participants in M-PL arm were excluded.||||< 0.001
72610752|NCT02065557|144750157|SUPERIORITY|one-sample two-sided Chi-square test||||||0.292||||||Adjusted p-value from a sequentially rejective multiple test procedure, testing co-primary and ranked secondary endpoints 1st for M-SD+M-HD, then for individual adalimumab dose groups (M-HD, M-SD) against the respective external placebo rate (14.79%)|rejective multiple test procedure|controlling familywise Type I error of 5% in a strong sense||Efficacy analysis was based on the modified Intent-To-Treat-Efficacy (mITT-E) population for the maintenance period. The mITT-E population was a subpopulation of the mITT population, where participants in M-PL arm were excluded.||||0.292
72610753|NCT02065557|144750157|SUPERIORITY|one-sample two-sided Chi-square test|||||<|0.001||||||Adjusted p-value from a sequentially rejective multiple test procedure, testing co-primary and ranked secondary endpoints 1st for M-SD+M-HD, then for individual adalimumab dose groups (M-HD, M-SD) against the respective external placebo rate (14.79%)|rejective multiple test procedure|controlling familywise Type I error of 5% in a strong sense||Efficacy analysis was based on the modified Intent-To-Treat-Efficacy (mITT-E) population for the maintenance period. The mITT-E population was a subpopulation of the mITT population, where participants in M-PL arm were excluded.||||< 0.001
72610754|NCT02065557|144750157|SUPERIORITY|one-sample two-sided Chi-square test|||||<|0.001||||||Adjusted p-value from a sequentially rejective multiple test procedure, testing co-primary and ranked secondary endpoints 1st for M-SD+M-HD, then for individual adalimumab dose groups (M-HD, M-SD) against the respective external placebo rate (14.79%)|rejective multiple test procedure|controlling familywise Type I error of 5% in a strong sense||Efficacy analysis was based on the modified Intent-To-Treat-Efficacy (mITT-E) population for the maintenance period. The mITT-E population was a subpopulation of the mITT population, where participants in M-PL arm were excluded.||||< 0.001
72610755|NCT02065557|144750157|SUPERIORITY|one-sample two-sided Chi-square test||||||0.292||||||Adjusted p-value from a sequentially rejective multiple test procedure, testing co-primary and ranked secondary endpoints 1st for M-SD+M-HD, then for individual adalimumab dose groups (M-HD, M-SD) against the respective external placebo rate (14.79%)|rejective multiple test procedure|controlling familywise Type I error of 5% in a strong sense||Efficacy analysis was based on the modified Intent-To-Treat-Efficacy (mITT-E) population for the maintenance period. The mITT-E population was a subpopulation of the mITT population, where participants in M-PL arm were excluded.||||0.292
72418226|NCT01984684|144346834|NON_INFERIORITY|A 2-sided 95% confidence interval (CI) for noninferiority testing was computed based on the difference in responder rates for vancomycin + aztreonam and delafloxacin at the primary endpoint. If the upper limit (UL) of the CI was less than 0.10, delafloxacin would be considered noninferior to vancomycin + aztreonam.|Difference in Responder Rates|3.1|||||TWO_SIDED|95.0|-2.0|8.3||||||||8.3|-2.0|
72418227|NCT01984684|144346835|NON_INFERIORITY|Analysis of the investigator's assessment of response of signs and symptoms of infection (cure only) was performed using the Miettinen-Nurminen method without stratification for the ITT analysis set.|Difference in Cure Rates|-2.0|||||TWO_SIDED|95.0|-8.6|4.6||||||||4.6|-8.6|
72418228|NCT01984684|144346836|NON_INFERIORITY|Analysis of the investigator's assessment of response (cure only) at the Late Follow-up Visit was assessed using the Miettinen-Nurminen method without stratification.|Difference in Cure Rates|-3.1|||||TWO_SIDED|95.0|-9.3|3.1||||||||3.1|-9.3|
72418229|NCT01375114|144346837|OTHER|||||||0.67|||||||Chi-squared|||||||0.67
72610756|NCT02065557|144750158|SUPERIORITY|one-sample two-sided Chi-square test||||||0.382||||||Adjusted p-value from a sequentially rejective multiple test procedure, testing co-primary and ranked secondary endpoints 1st for M-SD+M-HD, then for individual adalimumab dose groups (M-HD, M-SD) against the respective external placebo rate (24.08%)|rejective multiple test procedure|controlling familywise Type I error of 5% in a strong sense||Efficacy analysis was based on the modified Intent-To-Treat-Efficacy (mITT-E) population for the maintenance period. The mITT-E population was a subpopulation of the mITT population, where participants in M-PL arm were excluded.||||0.382
72610757|NCT02065557|144750158|SUPERIORITY|one-sample two-sided Chi-square test||||||1||||||Adjusted p-value from a sequentially rejective multiple test procedure, testing co-primary and ranked secondary endpoints 1st for M-SD+M-HD, then for individual adalimumab dose groups (M-HD, M-SD) against the respective external placebo rate (24.08%)|rejective multiple test procedure|controlling familywise Type I error of 5% in a strong sense||Efficacy analysis was based on the modified Intent-To-Treat-Efficacy (mITT-E) population for the maintenance period. The mITT-E population was a subpopulation of the mITT population, where participants in M-PL arm were excluded.||||1.000
72610758|NCT02065557|144750158|SUPERIORITY|one-sample two-sided Chi-square test||||||1||||||Adjusted p-value from a sequentially rejective multiple test procedure, testing co-primary and ranked secondary endpoints 1st for M-SD+M-HD, then for individual adalimumab dose groups (M-HD, M-SD) against the respective external placebo rate (24.08%)|rejective multiple test procedure|controlling familywise Type I error of 5% in a strong sense||Efficacy analysis was based on the modified Intent-To-Treat-Efficacy (mITT-E) population for the maintenance period. The mITT-E population was a subpopulation of the mITT population, where participants in M-PL arm were excluded.||||1.000
72610759|NCT02065557|144750158|SUPERIORITY|one-sample two-sided Chi-square test||||||0.344||||||Adjusted p-value from a sequentially rejective multiple test procedure, testing co-primary and ranked secondary endpoints 1st for M-SD+M-HD, then for individual adalimumab dose groups (M-HD, M-SD) against the respective external placebo rate (24.08%)|rejective multiple test procedure|controlling familywise Type I error of 5% in a strong sense||Efficacy analysis was based on the modified Intent-To-Treat-Efficacy (mITT-E) population for the maintenance period. The mITT-E population was a subpopulation of the mITT population, where participants in M-PL arm were excluded.||||0.344
72610760|NCT02065557|144750158|SUPERIORITY|one-sample two-sided Chi-square test||||||0.559||||||Adjusted p-value from a sequentially rejective multiple test procedure, testing co-primary and ranked secondary endpoints 1st for M-SD+M-HD, then for individual adalimumab dose groups (M-HD, M-SD) against the respective external placebo rate (24.08%)|rejective multiple test procedure|controlling familywise Type I error of 5% in a strong sense||Efficacy analysis was based on the modified Intent-To-Treat-Efficacy (mITT-E) population for the maintenance period. The mITT-E population was a subpopulation of the mITT population, where participants in M-PL arm were excluded.||||0.559
72610761|NCT02065557|144750158|SUPERIORITY|one-sample two-sided Chi-square test||||||0.815||||||Adjusted p-value from a sequentially rejective multiple test procedure, testing co-primary and ranked secondary endpoints 1st for M-SD+M-HD, then for individual adalimumab dose groups (M-HD, M-SD) against the respective external placebo rate (24.08%)|rejective multiple test procedure|controlling familywise Type I error of 5% in a strong sense||Efficacy analysis was based on the modified Intent-To-Treat-Efficacy (mITT-E) population for the maintenance period. The mITT-E population was a subpopulation of the mITT population, where participants in M-PL arm were excluded.||||0.815
72610762|NCT00250588|144750159|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.0||||0.05|TWO_SIDED|95.0|0.63|7.4||Bonferroni adjustment.|Mixed Models Analysis|Adjusted for child's age, race/ethnicity, Spanish, mother's education.||The primary effects of interest, condition and condition by time are fixed effects. PedsQL™ scores were analyzed as continuous normal outcomes with mixed effects regression models, which accounts for repeated measures over time for T2 and T3. Independent variables included baseline measure, time, asthma severity, condition, and condition by time interaction. We report the differences across groups in the adjusted mean changes over time.||7.4|0.63|0.05
72610763|NCT00250588|144750159|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.1||||0.05|TWO_SIDED|95.0|-0.21|6.4||Bonferroni adjustment|Mixed Models Analysis|Adjusted for child's age, race/ethnicity, Spanish, mother's education.||The primary effects of interest, condition and condition by time are fixed effects. PedsQL™ scores were analyzed as continuous normal outcomes with mixed effects regression models, which accounts for repeated measures over time for T2 and T3. Independent variables included baseline measure, time, asthma severity, condition, and condition by time interaction. We report the differences across groups in the adjusted mean changes over time.||6.4|-0.21|0.05
72610764|NCT00250588|144750160|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.49||||0.21|TWO_SIDED|95.0|0.18|1.38|||Regression, Logistic|Adjustment for age, race/ethnicity, Spanish language and mother's education||||1.38|0.18|0.21
72610765|NCT00250588|144750160|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.22||||0.85|TWO_SIDED|95.0|0.53|2.83||adjustment for age, race/ethnicity, Spanish language and mother's education|Regression, Logistic|||||2.83|0.53|0.85
72418230|NCT01375114|144346838|OTHER|||||||0.71|||||||Chi-squared|||||||0.71
72418231|NCT01375114|144346839|OTHER|||||||0.34|||||||Chi-squared|||||||0.34
72418232|NCT01375114|144346840|OTHER|||||||0.36|||||||Chi-squared|||||||0.36
72418233|NCT01375114|144346841|OTHER|||||||0.56|||||||Chi-squared|||||||0.56
72418234|NCT00541450|144346927|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||ANCOVA|For Least Squares Mean, the ANCOVA model included a term for treatment and the baseline value as a covariate.||||||0.002
72610766|NCT00250588|144750161|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.33||||0.011|TWO_SIDED|95.0|0.13|0.82|||Regression, Logistic|All analyses accounted for repeated measures and included the same terms in the model described previously.||Symptom frequency and utilization were analyzed using generalized linear mixed models (GLMM), with appropriate distribution and link functions. Nighttime symptoms is a dichotomous outcome and a logistic model was constructed.||0.82|0.13|0.011
72610767|NCT02737722|144750200|SUPERIORITY|||||||0.5152|||||||Fisher Exact|||Day 1 (Visit 2)||||0.5152
72610768|NCT02737722|144750200|SUPERIORITY|||||||1|||||||Fisher Exact|||Day 1 (Visit 2)||||1.0000
72610769|NCT02737722|144750200|SUPERIORITY|||||||1|||||||Fisher Exact|||Day 2 (Visit 3)||||1.0000
72610770|NCT02737722|144750200|SUPERIORITY|||||||1|||||||Fisher Exact|||Day 2 (Visit 3)||||1.0000
72610771|NCT02737722|144750200|SUPERIORITY|||||||1|||||||Fisher Exact|||Day 9 (Visit 4)||||1.0000
72610772|NCT02737722|144750200|SUPERIORITY|||||||1|||||||Fisher Exact|||Day 9 (Visit 4)||||1.0000
72610773|NCT02737722|144750200|SUPERIORITY|||||||1|||||||Fisher Exact|||Day 15 (Visit 5)||||1.0000
72610774|NCT02737722|144750200|SUPERIORITY|||||||0.3636|||||||Fisher Exact|||Day 15 (Visit 5)||||0.3636
72610775|NCT02737722|144750201|SUPERIORITY|||||||0.172|||||||Wilcoxon Rank Sum Test|||||||0.172
72610776|NCT02737722|144750201|SUPERIORITY|||||||0.365|||||||Wilcoxon Rank Sum Test|||||||0.365
72610777|NCT02737722|144750201|SUPERIORITY|||||||0.619|||||||Wilcoxon Rank Sum Test|||||||0.619
72610778|NCT02737722|144750202|SUPERIORITY|||||||0.432|||||||Wilcoxon Rank Sum Test|||||||0.432
72610779|NCT02737722|144750202|SUPERIORITY|||||||0.435|||||||Wilcoxon Rank Sum Test|||||||0.435
72610780|NCT02737722|144750202|SUPERIORITY|||||||0.715|||||||Wilcoxon Rank Sum Test|||||||0.715
72610781|NCT02737722|144750203|SUPERIORITY|||||||0.519|||||||Wilcoxon Rank Sum Test|||||||0.519
72610782|NCT02737722|144750203|SUPERIORITY|||||||0.519|||||||Wilcoxon Rank Sum Test|||||||0.519
72610783|NCT02737722|144750203|SUPERIORITY|||||||0.153|||||||Wilcoxon Rank Sum Test|||||||0.153
72610784|NCT02737722|144750204|SUPERIORITY|||||||0.464|||||||Wilcoxon Rank Sum Test|||||||0.464
72610785|NCT02737722|144750204|SUPERIORITY|||||||0.464|||||||Wilcoxon Rank Sum Test|||||||0.464
72610786|NCT02737722|144750204|SUPERIORITY|||||||0.465|||||||Wilcoxon Rank Sum Test|||||||0.465
72610787|NCT02737722|144750205|SUPERIORITY|||||||0.361|||||||Wilcoxon Rank Sum Test|||||||0.361
72610788|NCT02737722|144750205|SUPERIORITY|||||||0.519|||||||Wilcoxon Rank Sum Test|||||||0.519
72610789|NCT02737722|144750205|SUPERIORITY|||||||0.153|||||||Wilcoxon Rank Sum Test|||||||0.153
72610790|NCT02737722|144750206|SUPERIORITY|||||||0.465|||||||Wilcoxon Rank Sum Test|||||||0.465
72610791|NCT02737722|144750206|SUPERIORITY|||||||0.464|||||||Wilcoxon Rank Sum Test|||||||0.464
72610792|NCT02737722|144750206|SUPERIORITY|||||||0.465|||||||Wilcoxon Rank Sum Test|||||||0.465
72610793|NCT02737722|144750208|SUPERIORITY|||||||0.465|||||||Wilcoxon Rank Sum Test|||||||0.465
72610794|NCT02737722|144750208|SUPERIORITY|||||||0.464|||||||Wilcoxon Rank Sum Test|||||||0.464
72610795|NCT02737722|144750208|SUPERIORITY|||||||0.465|||||||Wilcoxon Rank Sum Test|||||||0.465
72610796|NCT00477685|144750221|SUPERIORITY_OR_OTHER|||||||0.01||95.0|||||t-test, 2 sided|||Null hypothesis: the postoperative intraocular pressure at 90 days equals the preoperative intraocular pressure at baseline.||||0.01
72610797|NCT03040726|144750239|OTHER|||||||0.98|||||||Wilcoxon (Mann-Whitney)|||||||0.98
72610798|NCT03040726|144750240|OTHER|||||||0.4|||||||Wilcoxon (Mann-Whitney)|||||||0.40
72610799|NCT03040726|144750241|OTHER|||||||0.79|||||||Wilcoxon (Mann-Whitney)|||||||0.79
72610800|NCT03040726|144750242|OTHER|||||||0.57|||||||Wilcoxon (Mann-Whitney)|||||||0.57
72610801|NCT03658980|144750277|SUPERIORITY||Odds Ratio (OR)|0.233|||<|0.001|TWO_SIDED|95.0|0.131|0.415|||Regression, Logistic|||||0.415|0.131|<0.001
72610802|NCT05471505|144750279|OTHER||Hazard Ratio (HR)|0.752|||<|0.001|TWO_SIDED|95.0|0.719|0.787|||COX Proportional Hazards Regression|||||0.787|0.719|<0.001
72610803|NCT05471505|144750280|OTHER||Hazard Ratio (HR)|0.747|||<|0.001|TWO_SIDED|95.0|0.687|0.813|||COX Proportional Hazards Regression|||||0.813|0.687|<0.001
72610804|NCT05471505|144750281|OTHER||Hazard Ratio (HR)|0.909|||<|0.001|TWO_SIDED|95.0|0.862|0.958|||COX Proportional Hazards Regression|||||0.958|0.862|<0.001
72610805|NCT05471505|144750282|OTHER||Hazard Ratio (HR)|0.948||||0.378|TWO_SIDED|95.0|0.842|1.067|||COX Proportional Hazards Regression|||||1.067|0.842|0.378
72610806|NCT05471505|144750283|OTHER||Hazard Ratio (HR)|0.259|||<|0.001|TWO_SIDED|95.0|0.229|0.294|||COX Proportional Hazards Regression|||||0.294|0.229|<0.001
72610807|NCT05471505|144750284|OTHER||Hazard Ratio (HR)|0.767|||<|0.001|TWO_SIDED|95.0|0.7|0.84|||COX Proportional Hazards Regression|||||0.840|0.700|<0.001
72610808|NCT05471505|144750285|OTHER||Hazard Ratio (HR)|0.932||||0.022|TWO_SIDED|95.0|0.877|0.99|||COX Proportional Hazards Regression|||||0.990|0.877|0.022
72610809|NCT03353220|144750290|OTHER|||||||0.65||||||paired t test|t-test, 2 sided|||||||0.65
72610810|NCT03353220|144750291|OTHER|||||||0.0001||||||paired t test|t-test, 2 sided|||||||0.0001
72610811|NCT03353220|144750292|OTHER|||||||0.0017||||||paired t test|t-test, 2 sided|||||||0.0017
72610812|NCT03353220|144750296|OTHER|||||||0.0189|||||||t-test, 2 sided|||||||0.0189
72610813|NCT00315341|144750311|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||shift table analyses|||categorized changes in ALT/AST from BL:(1)BL transaminases(both ALT/AST)≤2X upper limit of normal(ULN)\& remained at this level;(2)BL transaminases ≤2X ULN(either ALT/AST)but increased(either ALT/AST)above this level at any time;(3)BL transaminases \>2X ULN(either ALT/AST)\& decreased and remained at ≤2X ULN(both ALT/AST);(4)BL transaminases(both ALT/AST)\>2X ULN \&remained at this level(both ALT/AST);(5)BL transaminases \>2X ULN(either ALT/AST)\& increased 2X above this level ever(either ALT/AST).||||< 0.05
72610814|NCT05539131|144750334|SUPERIORITY|The LMM analysis results refer to the F-statistics and associated p-values derived from linear mixed-effects models (LMMs), including fixed effects for time, group, and their interaction.||||||0.862||||||This is p-valu regarding time and group.|Mixed Models Analysis|||||||0.862
72610815|NCT05539131|144750335|SUPERIORITY|The LMM analysis results refer to the F-statistics and associated p-values derived from linear mixed-effects models (LMMs), including fixed effects for time, group, and their interaction.||||||0.662||||||This is p-valu regarding time and group.|Mixed Models Analysis|||||||0.662
72610816|NCT05539131|144750336|SUPERIORITY|The LMM analysis results refer to the F-statistics and associated p-values derived from linear mixed-effects models (LMMs), including fixed effects for time, group, and their interaction.||||||0.318||||||This is p-valu regarding time and group.|ANOVA|||||||0.318
72326260|NCT02722408|144175865|OTHER|||||||0.0011||||||Mixed-effects model for repeated measures analysis with change in HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84 (Met EAS Clinical Diagnosis of HoFH)||||0.0011
72418235|NCT00541450|144346928|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||ANCOVA|For Least Squares Mean, the ANCOVA model included a term for treatment and the baseline value as a covariate.||||||0.001
72418236|NCT00541450|144346929|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.16||||||95.0|-0.37|0.05|||ANCOVA|For Least Squares Mean, the ANCOVA model included a term for treatment and the baseline value as a covariate.||||0.05|-0.37|
72418237|NCT00541450|144346931|SUPERIORITY_OR_OTHER|||||||0.03||95.0|||||ANCOVA|For Least Squares Mean, the ANCOVA model included a term for treatment and the baseline value as a covariate.||||||0.030
72418238|NCT00803452|144346942|SUPERIORITY|||||||0.001|||||||t-test, 2 sided|||||||.001
72418239|NCT02816138|144346945|OTHER||||||<|0.001|||||||Regression, Linear|For change in depression severity (MADRS) over time, we used a linear mixed effects model with autoregressive of order 1 (AR(1)) temporal process.||||||<0.001
72418240|NCT02816138|144346946|OTHER|||||||0.761|||||||Wilcoxon (Mann-Whitney)|Wilcoxon signed-rank test||||||0.761
72418241|NCT02816138|144346947|OTHER|||||||0.084|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon signed-rank test assessing for change from baseline to 12-weeks||||0.084
72610817|NCT05539131|144750337|SUPERIORITY|||||||0.273|||||||ANOVA|||||||0.273
72326261|NCT02722408|144175865|OTHER|||||||0.0083||||||Mixed-effects model for repeated measures analysis with change in HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28 (Not Met EAS Clinical Diagnosis of HoFH)||||0.0083
72418242|NCT02816138|144346948|OTHER|||||||0.073|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon signed-rank test assessing for change from baseline to 12-weeks||||0.073
72418243|NCT02816138|144346949|OTHER|||||||0.002|||||||Wilcoxon (Mann-Whitney)|Wilcoxon signed-rank test||||||0.002
72418244|NCT02816138|144346950|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|Wilcoxon signed rank test||||||<0.001
72418245|NCT02816138|144346951|OTHER|||||||0.049|||||||Wilcoxon (Mann-Whitney)|Wilcoxon signed-rank test||||||0.049
72326262|NCT02722408|144175865|OTHER|||||||0.0314||||||Mixed-effects model for repeated measures analysis with change in HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56 (Not Met EAS Clinical Diagnosis of HoFH)||||0.0314
72418246|NCT02816138|144346952|OTHER|||||||0.502|||||||Wilcoxon (Mann-Whitney)|Wilcoxon signed rank test||||||0.502
72326263|NCT02722408|144175865|OTHER|||||||0.0533||||||Mixed-effects model for repeated measures analysis with change in HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84 (Not Met EAS Clinical Diagnosis of HoFH)||||0.0533
72418247|NCT02816138|144346953|OTHER|||||||0.049|||||||Wilcoxon (Mann-Whitney)|Wilcoxon signed rank test||||||0.049
72418248|NCT02816138|144346954|OTHER|||||||0.068|||||||Wilcoxon (Mann-Whitney)|Wilcoxon signed rank test||||||0.068
72418249|NCT02291679|144346963|SUPERIORITY||Odds Ratio (OR)|3.03|||<|0.0001|TWO_SIDED|95.0|1.76|5.2||P-value is obtained from the Cochran-Mantel-Haenszel (CMH) tests controlling for baseline SBM stratum and geographic region.|Cochran-Mantel-Haenszel||Placebo as reference. Odds ratio and 95% confidence interval (CI) for the odds ratio are obtained from the CMH tests controlling for baseline SBM stratum and geographic region.|||5.20|1.76|< 0.0001
72418250|NCT02291679|144346964|SUPERIORITY||LS Mean Difference|0.841|||<|0.0001|TWO_SIDED|95.0|0.505|1.176||P-value is based on a pairwise comparison versus placebo in an ANCOVA model with treatment group, baseline SBM stratum, and geographic region as factors and baseline value as covariate.|ANCOVA||Linaclotide - Placebo. Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment group, baseline SBM stratum, and geographic region as factors and baseline value as covariate.|||1.176|0.505|< 0.0001
72418251|NCT02291679|144346965|SUPERIORITY||LS Mean Difference|1.037|||<|0.0001|TWO_SIDED|95.0|0.636|1.438||P-value is based on a pairwise comparison versus placebo in an ANCOVA model with treatment group, baseline SBM stratum, and geographic region as factors and baseline value as covariate.|ANCOVA||Linaclotide - Placebo. Estimate and 95% CI are based on a LS mean difference from an ANCOVA model with treatment group, baseline SBM stratum, and geographic region as factors and baseline value as covariate.|||1.438|0.636|< 0.0001
72418252|NCT02291679|144346966|SUPERIORITY||LS Mean Difference|0.628|||<|0.0001|TWO_SIDED|95.0|0.45|0.806||P-value is based on a pairwise comparison versus placebo in an ANCOVA model with treatment group, baseline SBM stratum, and geographic region as factors and baseline value as covariate.|ANCOVA||Linaclotide - Placebo. Estimate and 95% CI are based on a LS mean difference from an ANCOVA model with treatment group, baseline SBM stratum, and geographic region as factors and baseline value as covariate.|||0.806|0.450|< 0.0001
72418253|NCT02291679|144346967|SUPERIORITY||LS Mean Difference|-0.329|||<|0.0001|TWO_SIDED|95.0|-0.449|-0.21||P-value is based on a pairwise comparison versus placebo in an ANCOVA model with treatment group, baseline SBM stratum, and geographic region as factors and baseline value as covariate.|ANCOVA||Linaclotide - Placebo. Estimate and 95% CI are based on a LS mean difference from an ANCOVA model with treatment group, baseline SBM stratum, and geographic region as factors and baseline value as covariate.|||-0.210|-0.449|< 0.0001
72418254|NCT02291679|144346968|SUPERIORITY||Odds Ratio (OR)|2.68||||0.0008|TWO_SIDED|95.0|1.47|4.87||P-value is obtained from the CMH tests controlling for geographic region.|Cochran-Mantel-Haenszel||Placebo as reference. Odds ratio and 95% CI for the odds ratio are obtained from the CMH tests controlling for geographic region.|||4.87|1.47|0.0008
72418255|NCT02291679|144346969|SUPERIORITY||Odds Ratio (OR)|2.58|||<|0.0001|TWO_SIDED|95.0|1.58|4.2||P-value is obtained from the CMH tests controlling for geographic region and baseline stratum.|Cochran-Mantel-Haenszel||Placebo as reference. Odds ratio and 95% CI for the odds ratio are obtained from the CMH tests controlling for geographic region and baseline stratum.|||4.20|1.58|< 0.0001
72610818|NCT05539131|144750338|SUPERIORITY|||||||0.639|||||||ANOVA|||||||0.639
72610819|NCT05539131|144750339|SUPERIORITY|||||||0.452|||||||ANOVA|||||||0.452
72418256|NCT02291679|144346970|SUPERIORITY||Odds Ratio (OR)|2.15||||0.0002|TWO_SIDED|95.0|1.42|3.26||P-value is obtained from the CMH tests controlling for geographic region and baseline stratum.|Cochran-Mantel-Haenszel||Placebo as reference. Odds ratio and 95% CI for the odds ratio are obtained from the CMH tests controlling for geographic region and baseline stratum.|||3.26|1.42|0.0002
72418257|NCT02291679|144346971|SUPERIORITY||Odds Ratio (OR)|1.49||||0.0342|TWO_SIDED|95.0|1.03|2.17||P-value is obtained from the CMH tests controlling for geographic region and baseline stratum.|Cochran-Mantel-Haenszel||Placebo as reference. Odds ratio and 95% CI for the odds ratio are obtained from the CMH tests controlling for geographic region and baseline stratum.|||2.17|1.03|0.0342
72418258|NCT02291679|144346972|SUPERIORITY||LS Mean Difference|-0.319||||0.0063|TWO_SIDED|95.0|-0.548|-0.09||P-value is based on a pairwise comparison versus placebo in an ANCOVA model with treatment group, baseline SBM stratum, and geographic region as factors and baseline value as covariate.|ANCOVA||Linaclotide - Placebo. Estimate and 95% CI are based on a LS mean difference from an ANCOVA model with treatment group, baseline SBM stratum, and geographic region as factors and baseline value as covariate.|||-0.090|-0.548|0.0063
72610820|NCT01898078|144750395|SUPERIORITY_OR_OTHER||Least Squares Mean Ratio|0.97|||||TWO_SIDED|90.0|0.85|1.12|||||Estimates for each PK parameter were obtained using a mixed effects model of log (PK parameter) with fixed terms for the treatment effect, sequence effect, period effect and random terms for participants within sequence.|The confidence intervals are calculated for the difference in the LS means of the ln-transformed Cmax plain values (difference = Fed/Fasted). Antilogs of the confidence limits for the difference are taken to construct the confidence intervals for the ratio of the geometric means.||1.12|0.85|
72418259|NCT02291679|144346973|SUPERIORITY||LS Mean Difference|-0.178||||0.1028|TWO_SIDED|95.0|-0.391|0.036||P-value is based on a pairwise comparison versus placebo in an ANCOVA model with treatment group, baseline SBM stratum, and geographic region as factors and baseline value as covariate.|ANCOVA||Linaclotide - Placebo. Estimate and 95% CI are based on a LS mean difference from an ANCOVA model with treatment group, baseline SBM stratum, and geographic region as factors and baseline value as covariate.|||0.036|-0.391|0.1028
72418260|NCT02291679|144346974|SUPERIORITY||Odds Ratio (OR)|2.78||||0.0001|TWO_SIDED|95.0|1.61|4.8||P-value is obtained from the CMH tests controlling for baseline SBM stratum and geographic region.|Cochran-Mantel-Haenszel||Placebo as reference. Odds ratio and 95% CI for the odds ratio are obtained from the CMH tests controlling for baseline SBM stratum and geographic region.|||4.80|1.61|0.0001
72418261|NCT00981084|144346975|SUPERIORITY_OR_OTHER||||||=|0.19||95.0|||||t-test, 2 sided|||We used a crossover design to exame whether a single dose of armodafinil would improve cognition in MS. For hypothesis testing analyses, we used a statistical approach that accounts for period (session) effects. We subtracted session 2 performance from session 1 performance on the RVLT learning, yeilding a difference score. we conducted an independent samples t test with treatment order as the independent variable (A/P vs. P/A) and the difference score as the dependent variable.||||= .19
72418262|NCT00981084|144346975|SUPERIORITY_OR_OTHER||||||=|0.0005||95.0|||||t-test, 2 sided|||We used a crossover design to exame whether a single dose of armodafinil would improve cognition in MS. For hypothesis testing analyses, we used a statistical approach that accounts for period (session) effects. We subtracted session 2 performance from session 1 performance on the RVLT delay, yielding a difference score. we conducted an independent samples t test with treatment order as the independent variable (A/P vs. P/A) and the difference score as the dependent variable.||||= .0005
72418263|NCT00981084|144346975|SUPERIORITY_OR_OTHER||||||=|0.21||95.0|||||t-test, 2 sided|||We used a crossover design to exame whether a single dose of armodafinil would improve cognition in MS. For hypothesis testing analyses, we used a statistical approach that accounts for period (session) effects. We subtracted session 2 performance from session 1 performance on the BVMT learning, yeilding a difference score. we conducted an independent samples t test with treatment order as the independent variable (A/P vs. P/A) and the difference score as the dependent variable.||||= .21
72418264|NCT00981084|144346975|SUPERIORITY_OR_OTHER||||||=|0.1||95.0|||||t-test, 2 sided|||We used a crossover design to exame whether a single dose of armodafinil would improve cognition in MS. For hypothesis testing analyses, we used a statistical approach that accounts for period (session) effects. We subtracted session 2 performance from session 1 performance on the BVMT delay, yielding a difference score. we conducted an independent samples t test with treatment order as the independent variable (A/P vs. P/A) and the difference score as the dependent variable.||||= .10
72610821|NCT01898078|144750396|SUPERIORITY_OR_OTHER||Least Square Mean Ratio|1.16|||||TWO_SIDED|90.0|1.01|1.34|||||Estimates for each PK parameter were obtained using a mixed effects model of log (PK parameter) with fixed terms for the treatment effect, sequence effect, period effect and random terms for participants within sequence.|The confidence intervals are calculated for the difference in the LS means of the ln-transformed AUC(last) plain values (difference = Fed/Fasted). Antilogs of the confidence limits for the difference are taken to construct the confidence intervals for the ratio of the geometric mean.||1.34|1.01|
72610822|NCT01898078|144750397|SUPERIORITY_OR_OTHER||Least Square Mean Ratio|1.15|||||TWO_SIDED|90.0|0.96|1.39|||||Estimates for each PK parameter were obtained using a mixed effects model of log(PK parameter) with fixed terms for the treatment effect, sequence effect, period effect and random terms for participants within sequence.|The confidence intervals are calculated for the difference in the LS means of the ln-transformed AUC∞ plain values (difference = Fed/Fasted). Antilogs of the confidence limits for the difference are taken to construct the confidence intervals for the ratio of the geometric mean||1.39|0.96|
72418265|NCT00981084|144346976|SUPERIORITY_OR_OTHER|||||||0.33||95.0|||||t-test, 2 sided|||We used a crossover design to exame whether a single dose of armodafinil would improve cognition in MS. For hypothesis testing analyses, we used a statistical approach that accounts for period (session) effects. We subtracted session 2 performance from session 1 performance on the CPT, yielding a difference score. we conducted an independent samples t test with treatment order as the independent variable (A/P vs. P/A) and the difference score as the dependent variable.||||.33
72418266|NCT00981084|144346977|SUPERIORITY_OR_OTHER|||||||0.37||95.0|||||t-test, 2 sided|||We used a crossover design to examine whether a single dose of armodafinil would improve cognition in MS. For hypothesis testing analyses, we used a statistical approach that accounts for period (session) effects. We subtracted session 2 performance from session 1 performance on the Stroop, yielding a difference score. We conducted an independent samples t-test with treatment order as the independent variable (A/P vs. P/A) and the difference score as the dependent variable.||||.37
72610823|NCT01075048|144750405|SUPERIORITY|||||||0.3815|||||||Log Rank|||||||0.3815
72610824|NCT01075048|144750405|SUPERIORITY|||||||0.19|||||||Peto-Peto-Prentice|||||||0.1900
72610825|NCT01075048|144750405|SUPERIORITY|||||||0.1986|||||||Generalized Wilcoxon|||||||0.1986
72326264|NCT02722408|144175866|OTHER|||||||0.3657||||||Mixed-effects model for repeated measures analysis with percent change in TC as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28 (Negative LDLr)||||0.3657
72610826|NCT01075048|144750405|SUPERIORITY|||||||0.2617|||||||Tarone-Ware|||||||0.2617
72610827|NCT01075048|144750406|SUPERIORITY|||||||0.4488|||||||Log Rank|||||||0.4488
72418267|NCT00981084|144346978|SUPERIORITY_OR_OTHER|||||||0.53||95.0|||||t-test, 2 sided|||We used a crossover design to examine whether a single dose of armodafinil would improve cognition in MS. For hypothesis testing analyses, we used a statistical approach that accounts for period (session) effects. We subtracted session 2 performance from session 1 performance on the Word Generation, yielding a difference score. We conducted an independent samples t-test with treatment order as the independent variable (A/P vs. P/A) and the difference score as the dependent variable.||||.53
72610828|NCT01075048|144750406|SUPERIORITY|||||||0.2887|||||||Peto-Peto-Prentice|||||||0.2887
72610829|NCT01075048|144750406|SUPERIORITY|||||||0.1851|||||||Generalized Wilcoxon|||||||0.1851
72610830|NCT01075048|144750406|SUPERIORITY|||||||0.2495|||||||Tarone-Ware|||||||0.2495
72610831|NCT01075048|144750408|SUPERIORITY|||||||0.2804|||||||Log Rank|||OS data cutoff as of 12 Oct 2012||||0.2804
72610832|NCT01075048|144750408|SUPERIORITY|||||||0.2469|||||||Log Rank|||OS data cutoff as of 29 Mar 2013||||0.2469
72610833|NCT01075048|144750408|SUPERIORITY|||||||0.1334|||||||Log Rank|||OS data cutoff as of 25 Jul 2013||||0.1334
72610834|NCT01075048|144750408|SUPERIORITY|||||||0.2159|||||||Log Rank|||OS data cutoff as of 20 Feb 2015||||0.2159
72610835|NCT04596293|144750412|OTHER|||||||1|||||||Fisher Exact|||||||1.0000
72610836|NCT04596293|144750412|OTHER|||||||1|||||||Fisher Exact|||||||1.0000
72610837|NCT04596293|144750413|OTHER|||||||0.6351|||||||Fisher Exact|||||||0.6351
72610838|NCT04596293|144750413|OTHER|||||||0.3108|||||||Fisher Exact|||||||0.3108
72610839|NCT04596293|144750414|OTHER|||||||1|||||||Fisher Exact|||||||1.0000
72326265|NCT02722408|144175866|OTHER|||||||0.1983||||||Mixed-effects model for repeated measures analysis with percent change in TC as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56 (Negative LDLr)||||0.1983
72418268|NCT02048072|144346979|SUPERIORITY_OR_OTHER|||||||0.02|||||||t-test, 1 sided|||||||0.02
72610840|NCT04596293|144750414|OTHER|||||||0.6594|||||||Fisher Exact|||||||0.6594
72610841|NCT04596293|144750415|OTHER|||||||0.5808|||||||ANCOVA|||||||0.5808
72610842|NCT04596293|144750415|OTHER|||||||0.2143|||||||ANCOVA|||||||0.2143
72610843|NCT01287936|144750417|SUPERIORITY||||||<|0.001|||||||Wilcoxon Signed Rank test|||||||<0.001
72610844|NCT01287936|144750419|SUPERIORITY|||||||0.004|||||||Wilcoxon Signed Rank test|||||||0.004
72610845|NCT01140906|144750426|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.53|STANDARD_ERROR_OF_MEAN|1.09|<|0.0001|TWO_SIDED|95.0|-7.66|-3.4||Since p-value \<0.025, hierarchically testing continued.|MMRM||To adjust for multiplicity the two doses of vortioxetine were tested separately versus placebo in the primary and key secondary efficacy analyses at a Bonferroni-corrected significance level of 0.025.|As soon as an endpoint was non-significant at the 0.025 level of significance, the testing procedure was stopped for all subsequent endpoints.||-3.40|-7.66|<0.0001
72610846|NCT01140906|144750426|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.09|STANDARD_ERROR_OF_MEAN|1.08|<|0.0001|TWO_SIDED|95.0|-9.21|-4.97||Since p-value \<0.025, hierarchically testing continued.|MMRM||To adjust for multiplicity the two doses of vortioxetine were tested separately versus placebo in the primary and key secondary efficacy analyses at a Bonferroni-corrected significance level of 0.025.|As soon as an endpoint was non-significant at the 0.025 level of significance, the testing procedure was stopped for all subsequent endpoints.||-4.97|-9.21|<0.0001
72610847|NCT01140906|144750426|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.45|STANDARD_ERROR_OF_MEAN|1.07|<|0.0001|TWO_SIDED|95.0|-11.55|-7.35||This treatment arm was not in the testing sequence. A nominal p-value is provided.|MMRM|||||-7.35|-11.55|<0.0001
72610848|NCT01140906|144750427|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.8|||<|0.0001|TWO_SIDED|95.0|1.76|4.47||Wald's test. Since p-value \<0.025, hierarchically testing continued.|Adjusted Odds Ratio||To adjust for multiplicity the two doses of vortioxetine were tested separately versus placebo in the primary and key secondary efficacy analyses at a Bonferroni-corrected significance level of 0.025.|As soon as an endpoint was non-significant at the 0.025 level of significance, the testing procedure was stopped for all subsequent endpoints.||4.47|1.76|<0.0001
72610849|NCT01140906|144750427|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.36|||<|0.0001|TWO_SIDED|95.0|2.1|5.36||Wald's test. Since p-value \<0.025, hierarchically testing continued.|Adjusted Odds Ratio||To adjust for multiplicity the two doses of vortioxetine were tested separately versus placebo in the primary and key secondary efficacy analyses at a Bonferroni-corrected significance level of 0.025.|As soon as an endpoint was non-significant at the 0.025 level of significance, the testing procedure was stopped for all subsequent endpoints.||5.36|2.10|<0.0001
72610850|NCT01140906|144750427|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.94|||<|0.0001|TWO_SIDED|95.0|3.61|9.78||This treatment arm was not in the testing sequence. A nominal p-value is provided.|Adjusted Odds Ratio|||||9.78|3.61|<0.0001
72610851|NCT01140906|144750428|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.69|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-0.94|-0.44||Since p-value \<0.025, hierarchically testing continued.|MMRM||To adjust for multiplicity the two doses of vortioxetine were tested separately versus placebo in the primary and key secondary efficacy analyses at a Bonferroni-corrected significance level of 0.025.|As soon as an endpoint was non-significant at the 0.025 level of significance, the testing procedure was stopped for all subsequent endpoints.||-0.44|-0.94|<0.0001
72610852|NCT01140906|144750428|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.95|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-1.2|-0.7||Since p-value \<0.025, hierarchically testing continued.|MMRM||To adjust for multiplicity the two doses of vortioxetine were tested separately versus placebo in the primary and key secondary efficacy analyses at a Bonferroni-corrected significance level of 0.025.|As soon as an endpoint was non-significant at the 0.025 level of significance, the testing procedure was stopped for all subsequent endpoints.||-0.70|-1.20|<0.0001
72610853|NCT01140906|144750428|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.12|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-1.36|-0.87||This treatment arm was not in the testing sequence. A nominal p-value is provided.|MMRM|||||-0.87|-1.36|<0.0001
72418269|NCT01031810|144346986|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.56|STANDARD_DEVIATION|10.81||0.012|TWO_SIDED|95.0|3.25|19.86|||paired t-test 2 sided|||Compare the mean differences between baseline (week00) and week12 hamd17 summary scores||19.86|3.25|0.012
72418270|NCT05878197|144347064|OTHER|||||||0.024||||||Linear Mixed Models: time-effect|Mixed Models Analysis|||||||0.024
72418271|NCT05878197|144347064|OTHER|||||||0.822||||||Linear mixed models: group-effect|Mixed Models Analysis|||||||0.822
72418272|NCT05878197|144347064|OTHER|||||||0.29||||||Linar mixed models: time\*group-effect|Mixed Models Analysis|||||||0.290
72418273|NCT05878197|144347064|OTHER||Mean Difference (Final Values)|1.8||||0.035|TWO_SIDED|95.0|0.1|3.4||Linear mixed models: evolution pre-post|Mixed Models Analysis|||||3.4|0.1|0.035
72418274|NCT05878197|144347064|OTHER||Mean Difference (Final Values)|1.8||||0.038|TWO_SIDED|95.0|0.1|3.4||Linear mixed models: evolution pre-post|Mixed Models Analysis|||||3.4|0.1|0.038
72418275|NCT05878197|144347064|OTHER||Mean Difference (Final Values)|0.0||||1|TWO_SIDED|95.0|-1.9|1.9||Linear mixed models: evolution pre-post|Mixed Models Analysis|||||1.9|-1.9|1.000
72418276|NCT05878197|144347065|OTHER|||||||0.107||||||Linear mixed models: time-effect|Mixed Models Analysis|||||||0.107
72418277|NCT05878197|144347065|OTHER|||||||0.996||||||Linear mixed models: group-effect|Mixed Models Analysis|||||||0.996
72418278|NCT05878197|144347065|OTHER|||||||0.639||||||Linear mixed models: time\*group-effect|Mixed Models Analysis|||||||0.639
72418279|NCT05878197|144347065|OTHER||Mean Difference (Final Values)|-0.1||||0.731|TWO_SIDED|95.0|-0.6|0.4||Linear mixed models: evolution pre-post|Mixed Models Analysis|||||0.4|-0.6|0.731
72418280|NCT05878197|144347065|OTHER||Mean Difference (Final Values)|-0.4||||0.217|TWO_SIDED|95.0|-1.1|0.3||Linear mixed models: evolution pre-post|Mixed Models Analysis|||||0.3|-1.1|0.217
72418281|NCT05878197|144347065|OTHER||Mean Difference (Final Values)|-0.3||||0.253|TWO_SIDED|95.0|-0.9|0.3||Linear mixed models: evolution pre-post|Mixed Models Analysis|||||0.3|-0.9|0.253
72418282|NCT05878197|144347066|OTHER|||||||0.024||||||Linear mixed models: time-effect|Mixed Models Analysis|||||||0.024
72418283|NCT05878197|144347066|OTHER|||||||0.449||||||Linear mixed models: group-effect|Mixed Models Analysis|||||||0.449
72418284|NCT05878197|144347066|OTHER|||||||0.786||||||Linear mixed models: time\*group-effect|Mixed Models Analysis|||||||0.786
72418285|NCT05878197|144347066|OTHER||Mean Difference (Final Values)|-3.3||||0.099|TWO_SIDED|95.0|-7.2|0.7||Linear mixed models: evolution pre-post|Mixed Models Analysis|||||0.7|-7.2|0.099
72418286|NCT05878197|144347066|OTHER||Mean Difference (Final Values)|-3.9||||0.074|TWO_SIDED|95.0|-8.3|0.4||Linear mixed models: evolution pre-post|Mixed Models Analysis|||||0.4|-8.3|0.074
72418287|NCT05878197|144347066|OTHER||Mean Difference (Final Values)|-1.7||||0.472|TWO_SIDED|95.0|-6.7|3.2||Linear mixed models: evolution pre-post|Mixed Models Analysis|||||3.2|-6.7|0.472
72418288|NCT05878197|144347067|OTHER|||||||0.115||||||Linear mixed models: time-effect|Mixed Models Analysis|||||||0.115
72418289|NCT05878197|144347067|OTHER|||||||0.516||||||Linear mixed models: group-effect|Mixed Models Analysis|||||||0.516
72418290|NCT05878197|144347067|OTHER|||||||0.276||||||Linear mixed models: time\*group-effect|Mixed Models Analysis|||||||0.276
72418291|NCT05878197|144347067|OTHER||Mean Difference (Final Values)|-6.5||||0.025|TWO_SIDED|95.0|-12.2|-0.9||Linear mixed models: evolution pre-post|Mixed Models Analysis|||||-0.9|-12.2|0.025
72418292|NCT05878197|144347067|OTHER||Mean Difference (Final Values)|-0.7||||0.794|TWO_SIDED|95.0|-6.4|4.9||Linear mixed models: evolution pre-post|Mixed Models Analysis|||||4.9|-6.4|0.794
72418293|NCT05878197|144347067|OTHER||Mean Difference (Final Values)|-1.0||||0.76|TWO_SIDED|95.0|-7.7|5.7||Linear mixed models: evolution pre-post|Mixed Models Analysis|||||5.7|-7.7|0.760
72418294|NCT04508699|144347083|OTHER|||||||0.36|||||||t-test, 1 sided|||||||0.36
72418295|NCT04508699|144347084|OTHER||||||<|0.05||||||reported p-value was calculated, is not indicating the threshold for statistical significance.|ANOVA|||||||<0.05
72418296|NCT04508699|144347085|OTHER||||||<|0.05||||||reported p-value was calculated, is not indicating the threshold for statistical significance.|ANOVA|||||||<0.05
72418297|NCT04508699|144347086|OTHER||||||<|0.05||||||reported p-value was calculated, is not indicating the threshold for statistical significance.|ANOVA|||||||<0.05
72418298|NCT04508699|144347087|OTHER||||||<|0.05||||||reported p-value was calculated, is not indicating the threshold for statistical significance.|ANOVA|||||||<0.05
72418299|NCT04508699|144347088|OTHER||||||<|1e-05||||||reported p-value was calculated, is not indicating the threshold for statistical significance.|t-test, 1 sided|||||||<0.00001
72610854|NCT01140906|144750429|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.24|STANDARD_ERROR_OF_MEAN|1.53||0.0007|TWO_SIDED|95.0|-8.25|-2.22||Since p-value \<0.025, hierarchically testing continued.|MMRM||To adjust for multiplicity the two doses of vortioxetine were tested separately versus placebo in the primary and key secondary efficacy analyses at a Bonferroni-corrected significance level of 0.025.|As soon as an endpoint was non-significant at the 0.025 level of significance, the testing procedure was stopped for all subsequent endpoints.||-2.22|-8.25|0.0007
72610855|NCT01140906|144750429|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.42|STANDARD_ERROR_OF_MEAN|1.58|<|0.0001|TWO_SIDED|95.0|-9.53|-3.31||Since p-value \<0.025, hierarchically testing continued.|MMRM||To adjust for multiplicity the two doses of vortioxetine were tested separately versus placebo in the primary and key secondary efficacy analyses at a Bonferroni-corrected significance level of 0.025.|As soon as an endpoint was non-significant at the 0.025 level of significance, the testing procedure was stopped for all subsequent endpoints.||-3.31|-9.53|<0.0001
72610856|NCT01140906|144750429|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.71|STANDARD_ERROR_OF_MEAN|1.54|<|0.0001|TWO_SIDED|95.0|-11.73|-5.69||This treatment arm was not in the testing sequence. A nominal p-value is provided.|MMRM|||||-5.69|-11.73|<0.0001
72610857|NCT01140906|144750430|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.32||||0.0016|TWO_SIDED|95.0|1.37|3.91||Wald's test. Since p-value \<0.025, hierarchically testing continued.|Adjusted Odds Ratio||To adjust for multiplicity the two doses of vortioxetine were tested separately versus placebo in the primary and key secondary efficacy analyses at a Bonferroni-corrected significance level of 0.025.|As soon as an endpoint was non-significant at the 0.025 level of significance, the testing procedure was stopped for all subsequent endpoints.||3.91|1.37|0.0016
72610858|NCT01140906|144750430|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.65||||0.0002|TWO_SIDED|95.0|1.58|4.44||Wald's test. Since p-value \<0.025, hierarchically testing continued.|Adjusted Odds Ratio||To adjust for multiplicity the two doses of vortioxetine were tested separately versus placebo in the primary and key secondary efficacy analyses at a Bonferroni-corrected significance level of 0.025.|As soon as an endpoint was non-significant at the 0.025 level of significance, the testing procedure was stopped for all subsequent endpoints.||4.44|1.58|0.0002
72610859|NCT01140906|144750430|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.01|||<|0.0001|TWO_SIDED|95.0|2.99|8.37||Wald's test. This treatment arm was not in the testing sequence. A nominal p-value is provided.|Adjusted for Odds Ratio|||||8.37|2.99|<0.0001
72610860|NCT01140906|144750431|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.24|STANDARD_ERROR_OF_MEAN|1.16||0.0054|TWO_SIDED|95.0|-5.51|-0.97||Since p-value \<0.025, hierarchically testing continued.|MMRM||To adjust for multiplicity the two doses of vortioxetine were tested separately versus placebo in the primary and key secondary efficacy analyses at a Bonferroni-corrected significance level of 0.025.|As soon as an endpoint was non-significant at the 0.025 level of significance, the testing procedure was stopped for all subsequent endpoints.||-0.97|-5.51|0.0054
72610861|NCT01140906|144750431|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.92|STANDARD_ERROR_OF_MEAN|1.11||0.0005|TWO_SIDED|95.0|-6.11|-1.73||Since p-value \<0.025, hierarchically testing continued.|MMRM||To adjust for multiplicity the two doses of vortioxetine were tested separately versus placebo in the primary and key secondary efficacy analyses at a Bonferroni-corrected significance level of 0.025.|As soon as an endpoint was non-significant at the 0.025 level of significance, the testing procedure was stopped for all subsequent endpoints.||-1.73|-6.11|0.0005
72610862|NCT01140906|144750431|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.93|STANDARD_ERROR_OF_MEAN|1.13|<|0.0001|TWO_SIDED|95.0|-9.16|-4.7||This treatment arm was not in the testing sequence. A nominal p-value is provided.|MMRM|||||-4.70|-9.16|<0.0001
72610863|NCT01140906|144750432|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.67|STANDARD_ERROR_OF_MEAN|0.59||0.2524|TWO_SIDED|95.0|-1.83|0.48||A nominal p-value is provided.|MMRM||No correction for multiplicity was made.|||0.48|-1.83|0.2524
72610864|NCT01140906|144750432|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.48|STANDARD_ERROR_OF_MEAN|0.59||0.4186|TWO_SIDED|95.0|-1.64|0.68||A nominal p-value is provided.|MMRM||No correction for multiplicity was made.|||0.68|-1.64|0.4186
72418300|NCT04508699|144347089|OTHER||||||<|1e-05||||||reported p-value was calculated, is not indicating the threshold for statistical significance.|t-test, 1 sided|||||||<0.00001
72418301|NCT04508699|144347090|OTHER||||||<|1e-05||||||reported p-value was calculated, is not indicating the threshold for statistical significance.|t-test, 1 sided|||||||<0.00001
72610865|NCT01140906|144750433|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.14|STANDARD_ERROR_OF_MEAN|0.41||0.7372|TWO_SIDED|95.0|-0.95|0.67||A nominal p-value is provided.|ANCOVA|||||0.67|-0.95|0.7372
72610866|NCT01140906|144750433|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.56|STANDARD_ERROR_OF_MEAN|0.41||0.169|TWO_SIDED|95.0|-0.24|1.37||A nominal p-value is provided.|ANCOVA|||||1.37|-0.24|0.1690
72610867|NCT00336544|144750435|NON_INFERIORITY_OR_EQUIVALENCE|Delta will be determined by the highest clinical cure-rate between the Cethromycin treatment group and the Clarithromycin treatment group, as follows: Greater than or equal to 90%, delta = -10%; Greater than or equal to 80% and less than 90%, delta = -15%, Greater than or equal to 70% and less than 80%, -20%)|Mean Difference (Net)|-5.7||||0.0769||95.0|-11.9|0.6|||Fisher Exact|||The rate of clinical cure in each treatment group was calculated (number of cures/number of patient eligible for analysis). Non-inferiority will be demonstrated when the lower limit of the two-sided 95% confidence interval for the difference in the clinical cure rate at the Test-of-Cure visit between treatment groups (Cethromycin -Clarithromycin) is greater than delta, and includes zero, for both Per-Protocol (PP) and Intent-to-Treat (ITT) analyses.||0.6|-11.9|0.0769
72418302|NCT04295005|144347100|OTHER|Group differences in the costs incurred after treatment initiation were evaluated based on an incremental cost approach using the Bang and Tsiatis estimator with possibly censored data.|||||<|0.001|||||||Bang and Tsiatis|||Total cost comparison.||||< 0.001
72418303|NCT04295005|144347100|OTHER|Group differences in the costs incurred after treatment initiation were evaluated based on an incremental cost approach using the Bang and Tsiatis estimator with possibly censored data.|||||<|0.001|||||||Bang and Tsiatis|||Total cost comparison.||||< 0.001
72326266|NCT02722408|144175866|OTHER|||||||0.297||||||Mixed-effects model for repeated measures analysis with percent change in TC as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84 (Negative LDLr)||||0.2970
72326267|NCT02722408|144175866|OTHER|||||||0.0092||||||Mixed-effects model for repeated measures analysis with percent change in TC as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28 (Defective LDLr)||||0.0092
72326268|NCT02722408|144175866|OTHER|||||||0.0049||||||Mixed-effects model for repeated measures analysis with percent change in TC as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56 (Defective LDLr)||||0.0049
72418304|NCT04295005|144347100|OTHER|Group differences in the costs incurred after treatment initiation were evaluated based on an incremental cost approach using the Bang and Tsiatis estimator with possibly censored data.|||||<|0.001|||||||Bang and Tsiatis|||Total cost comparison.||||< 0.001
72610868|NCT00336544|144750437|NON_INFERIORITY_OR_EQUIVALENCE|Delta will be determined by the highest clinical cure-rate between the Cethromycin treatment group and the Clarithromycin treatment group, as follows: Greater than or equal to 90%, delta = -10%; Greater than or equal to 80% and less than 90%, delta = -15%, Greater than or equal to 70% and less than 80%, -20%)|Mean Difference (Net)|-4.4||||0.0775||95.0|-9.1|0.3|||Fisher Exact|||The rate of clinical cure in each treatment group was calculated (number of cures/number of patient eligible for analysis). Non-inferiority will be demonstrated when the lower limit of the two-sided 95% confidence interval for the difference in the clinical cure rate at the Test-of-Cure visit between treatment groups (Cethromycin -Clarithromycin) is greater than delta, and includes zero, for both Per-Protocol (PP) and Intent-to-Treat (ITT) analyses.||0.3|-9.1|0.0775
72610869|NCT01649765|144750439|SUPERIORITY||Odds Ratio (OR)|1.49|||||TWO_SIDED|95.0|0.64|3.46||||||||3.46|0.64|
72610870|NCT01649765|144750440|SUPERIORITY||Odds Ratio (OR)|2.74|||||TWO_SIDED|95.0|1.15|6.54|||||Definition 1|||6.54|1.15|
72610871|NCT01649765|144750440|SUPERIORITY||Odds Ratio (OR)|2.92|||||TWO_SIDED|95.0|1.19|7.17|||||Definition 2|||7.17|1.19|
72610872|NCT03427411|144750480|NON_INFERIORITY|Non-inferiority was defined as response rates which were sufficiently similar (p\>0.20 by Fisher's exact test).||||||0.6143||||||The p value was calculated and was 0.6143 which is \> 0.2 (pre-defined threshold).|Fisher Exact|||||||0.6143
72610873|NCT02058095|144750504|SUPERIORITY|||||||0.04|||||||Wilcoxon (Mann-Whitney)|||||||0.04
72610874|NCT02058095|144750506|SUPERIORITY|||||||0.01|||||||Wilcoxon (Mann-Whitney)|||||||0.01
72610875|NCT00148798|144750511|SUPERIORITY_OR_OTHER|||||||0.0441|TWO_SIDED|95.0|||||Stratified Log Rank|||Primary efficacy analysis: To test equality of OS time between treatment groups, applying the two-sided stratified log-rank test (Stage IIIb vs IV, ECOG 0/1 vs 2) (α=5%).||||0.0441
72610876|NCT00148798|144750512|SUPERIORITY_OR_OTHER|||||||0.3869|TWO_SIDED|95.0|||||Stratified Log Rank|||To test equality of progression free survival time between treatment groups, applying the two-sided stratified log-rank test (α=5%).||||0.3869
72610877|NCT00148798|144750513|SUPERIORITY_OR_OTHER|||||||0.0101|TWO_SIDED|95.0|||||Cochran-Mantel-Haenszel|||The best overall response rate was compared in the Cochran-Mantel-Haenszel test (two-sided with α=5%).||||0.0101
72610878|NCT00148798|144750514|SUPERIORITY_OR_OTHER|||||||0.6801|TWO_SIDED|95.0|||||Cochran-Mantel-Haenszel|||The disease control rate was compared in the Cochran-Mantel-Haenszel test (two-sided with α=5%).||||0.6801
72610879|NCT00316004|144750519|SUPERIORITY_OR_OTHER|||||||0.55||95.0||||The p-value was not adjusted for multiple comparisons. Test compares proportions across all three treatment groups.|test for differences in proportions|||The null hypothesis is that there are no differences in the percent prevalence of poor outcome between the three groups.||||0.55
72610880|NCT00316004|144750520|SUPERIORITY_OR_OTHER|||||||0.59||95.0||||The p-value was not adjusted for multiple comparisons. Test compares proportions across all three treatment groups.|test for differences in proportions|Adjusted for multiple imputations||The null hypothesis is that there are no differences in the percent prevalence of poor outcome between the three treatment groups among patients with head AIS≥4.||||0.59
72610881|NCT00316004|144750521|SUPERIORITY_OR_OTHER|||||||0.67||95.0||||The p-value was not adjusted for multiple comparisons. Test compares proportions across all three treatment groups.|test for differences in proportions|Adjusted for multiple imputations.||The null hypothesis is that there are no differences in the percent prevalence of poor outcome between the three groups.||||0.67
72610882|NCT00316004|144750522|SUPERIORITY_OR_OTHER|||||||0.57||95.0||||The p-value was not adjusted for multiple comparisons. Test compares proportions across all three treatment groups.|test for differences in proportions|Adjusted for multiple imputations||The null hypothesis is that there are no differences in the percent prevalence of poor outcome between the three treatment groups among patients with head AIS≥2.||||0.57
72610883|NCT00316004|144750523|SUPERIORITY_OR_OTHER|||||||0.84||95.0||||The p-value was not adjusted for multiple comparisons. Test compares proportions across all three treatment groups.|test for proportions|Adjusted for multiple imputations||The null hypothesis is that there are no differences in the percent of patients at any level of disability between the three groups.||||.84
72418305|NCT04295005|144347100|OTHER|Group differences in the costs incurred after treatment initiation were evaluated based on an incremental cost approach using the Bang and Tsiatis estimator with possibly censored data.|||||<|0.001|||||||Bang and Tsiatis|||Inpatient cost comparison||||< 0.001
72418306|NCT04295005|144347100|OTHER|Group differences in the costs incurred after treatment initiation were evaluated based on an incremental cost approach using the Bang and Tsiatis estimator with possibly censored data.|||||<|0.001|||||||Bang and Tsiatis|||Inpatient cost comparison.||||< 0.001
72418307|NCT04295005|144347100|OTHER|Group differences in the costs incurred after treatment initiation were evaluated based on an incremental cost approach using the Bang and Tsiatis estimator with possibly censored data.||||||0.126|||||||Bang and Tsiatis|||Inpatient cost comparison||||0.126
72610884|NCT00316004|144750524|SUPERIORITY_OR_OTHER|||||||0.88||95.0||||The p-value was not adjusted for multiple comparisons. Test compares proportions across all three treatment groups.|test for differences in proportions|The numbers differ from the JAMA manuscript because of typos and version control issues that were discovered after publication.||The null hypothesis is that there are no differences in the percent of patients who were alive on the 28th day after injury between the three groups.||||0.88
72610885|NCT00316004|144750525|SUPERIORITY_OR_OTHER|||||||0.88||95.0||||The p-value was not adjusted for multiple comparisons. Test compares proportions across all three treatment groups.|test for differences in proportions|The numbers differ from the JAMA manuscript because of typos and version control issues that were discovered after publication.||The null hypothesis is that there are no differences in the percent of patients who were alive on the day discharged from the hospital after injury between the three groups.||||0.88
72610886|NCT00316004|144750526|SUPERIORITY_OR_OTHER|||||||0.91||95.0||||The p-value was not adjusted for multiple comparisons. Test compares proportions across all three treatment groups.|test for differences in proportions|The numbers differ from the JAMA manuscript because of typos and version control issues that were discovered after publication.||The null hypothesis is that there are no differences in the percent of patients who were alive and free of ARDS from the day of injury to the 28th day after injury between the three groups.||||0.91
72610887|NCT00316004|144750527|SUPERIORITY_OR_OTHER|||||||0.81||95.0||||The p-value was not adjusted for multiple comparisons. Test compares averages across all three treatment groups.|ANOVA|The numbers differ from the JAMA manuscript because of typos and version control issues that were discovered after publication.||The null hypothesis is that there are no differences in average Worst Multiple Organ Dysfunction Scores (MODS) through day 28 between the three groups.||||0.81
72610888|NCT00316004|144750528|SUPERIORITY_OR_OTHER|||||||0.77||95.0||||The p-value was not adjusted for multiple comparisons. Test compares averages across all three treatment groups.|ANOVA|The numbers differ from the JAMA manuscript because of typos and version control issues that were discovered after publication.||The null hypothesis is that there are no differences in the average number of Ventilator-free days through day 28 between the three groups.||||0.77
72610889|NCT00316004|144750529|SUPERIORITY_OR_OTHER|||||||0.76||95.0||||The p-value was not adjusted for multiple comparisons. Test compares averages across all three treatment groups.|ANOVA|The numbers differ from the JAMA manuscript because of typos and version control issues that were discovered after publication.||The null hypothesis is that there are no differences in the average number of days alive out of the ICU through day 28 between the three groups.||||0.76
72610890|NCT00316004|144750530|SUPERIORITY_OR_OTHER|||||||0.43||95.0||||The p-value was not adjusted for multiple comparisons. Test compares averages across all three treatment groups.|ANOVA|The numbers differ from the JAMA manuscript because of typos and version control issues that were discovered after publication.||The null hypothesis is that there are no differences in the average number of days alive out of the hospital through day 28 between the three groups.||||0.43
72418308|NCT04295005|144347100|OTHER|Group differences in the costs incurred after treatment initiation were evaluated based on an incremental cost approach using the Bang and Tsiatis estimator with possibly censored data.|||||<|0.001|||||||Bang and Tsiatis|||Outpatient cost comparison.||||< 0.001
72418309|NCT04295005|144347100|OTHER|Group differences in the costs incurred after treatment initiation were evaluated based on an incremental cost approach using the Bang and Tsiatis estimator with possibly censored data.|||||<|0.001|||||||Bang and Tsiatis|||Outpatient cost comparison.||||< 0.001
72418310|NCT04295005|144347100|OTHER|Group differences in the costs incurred after treatment initiation were evaluated based on an incremental cost approach using the Bang and Tsiatis estimator with possibly censored data.|||||<|0.001|||||||Bang and Tsiatis|||Outpatient cost comparison.||||< 0.001
72418311|NCT04295005|144347100|OTHER|Group differences in the costs incurred after treatment initiation were evaluated based on an incremental cost approach using the Bang and Tsiatis estimator with possibly censored data.|||||<|0.001|||||||Bang and Tsiatis|||Medication cost comparison.||||< 0.001
72610891|NCT00316004|144750531|SUPERIORITY_OR_OTHER|||||||0.06||95.0||||The p-value was not adjusted for multiple comparisons. Test compares proportions across all three treatment groups.|test for differences in proportions|||The null hypothesis is that there are no differences in the percent of patients with any nosocomial infections through hospital stay between the three groups.||||0.06
72610892|NCT00316004|144750531|SUPERIORITY_OR_OTHER|||||||0.3||95.0||||The p-value was not adjusted for multiple comparisons. Test compares proportions across all three treatment groups.|test for differences in proportions|||The null hypothesis is that there are no differences in the percent of patients with pneumonia through hospital stay between the three groups.||||0.3
72418312|NCT04295005|144347100|OTHER|Group differences in the costs incurred after treatment initiation were evaluated based on an incremental cost approach using the Bang and Tsiatis estimator with possibly censored data.|||||<|0.001|||||||Bang and Tsiatis|||Medication cost comparison.||||< 0.001
72418313|NCT04295005|144347100|OTHER|Group differences in the costs incurred after treatment initiation were evaluated based on an incremental cost approach using the Bang and Tsiatis estimator with possibly censored data.|||||<|0.001|||||||Bang and Tsiatis|||Medication cost comparison.||||< 0.001
72418314|NCT00437645|144347120|NON_INFERIORITY_OR_EQUIVALENCE|Statistical analysis for non-inferiority of valsartan/amlodipine 160/5 mg to amlodipine 10 mg alone with a non-inferiority margin of 3 mm Hg|Mean Difference (Final Values)|-1.72|STANDARD_ERROR_OF_MEAN|0.65|||TWO_SIDED|95.0|-3.0|-0.44|||ANCOVA|||||-0.44|-3.00|
72418315|NCT03073148|144347129|EQUIVALENCE|alpha = 0.05||||||0.3577|||||||ANOVA|Repeated measures ANOVA comparing baseline, 1 day after treatment, and final assessment.||||||0.3577
72418316|NCT03073148|144347129|EQUIVALENCE|alpha = 0.05||||||0.9917|||||||ANOVA|Repeated measures ANOVA comparing baseline, 1 day after treatment, and final assessment.||||||0.9917
72418317|NCT03073148|144347130|EQUIVALENCE|alpha = 0.05||||||0.3239|||||||ANOVA|Repeated measures ANOVA comparing baseline, 1 day after treatment, and final assessment.||||||0.3239
72418318|NCT03073148|144347130|EQUIVALENCE|alpha = 0.05||||||0.8343|||||||ANOVA|Repeated measures ANOVA comparing baseline, 1 day after treatment, and final assessment.||||||0.8343
72418319|NCT03073148|144347131|EQUIVALENCE|alpha = 0.05||||||0.4134|||||||ANOVA|Repeated measures ANOVA comparing baseline, 1 day after treatment, and final assessment.||||||0.4134
72418320|NCT03073148|144347131|EQUIVALENCE|alpha = 0.05||||||0.1192|||||||ANOVA|Repeated measures ANOVA comparing baseline, 1 day after treatment, and final assessment.||||||0.1192
72418321|NCT03073148|144347133|EQUIVALENCE|alpha = 0.05||||||0.1753||||||Repeated measures ANOVA comparing baseline, 1 day after treatment, and final assessment.|ANOVA|Repeated measures ANOVA comparing baseline, 1 day after treatment, and final assessment.||||||0.1753
72418322|NCT03073148|144347133|EQUIVALENCE|alpha = 0.05||||||0.1843|||||||ANOVA|Repeated measures ANOVA comparing baseline, 1 day after treatment, and final assessment.||||||0.1843
72418323|NCT03073148|144347134|EQUIVALENCE|alpha = 0.05||||||0.0765|||||||ANOVA|Repeated measures ANOVA comparing baseline, 1 day after treatment, and final assessment.||||||0.0765
72418324|NCT03073148|144347134|EQUIVALENCE|alpha = 0.05||||||0.152|||||||ANOVA|Repeated measures ANOVA comparing baseline, 1 day after treatment, and final assessment.||||||0.1520
72418325|NCT03382782|144347147|SUPERIORITY||Mean Difference (Net)|0.36||||0.025|TWO_SIDED||||||ANOVA|degrees of freedom = (3, 172)||||||.025
72418326|NCT03382782|144347148|SUPERIORITY||Mean Difference (Net)|0.243||||0.784|TWO_SIDED||||||ANOVA|degrees of freedom = 2, 182||Intent-to-treat analyses||||0.784
72418327|NCT03382782|144347148|SUPERIORITY||Mean Difference (Net)|0.058||||0.81|TWO_SIDED||||||ANOVA|degrees of freedom = 1, 118||As-treated analyses||||0.810
72418328|NCT03382782|144347149|SUPERIORITY||Mean Difference (Net)|1.77||||0.174|TWO_SIDED||||||ANOVA|degrees of freedom = 2, 182||Intent-to-treat analyses||||0.174
72418329|NCT03382782|144347149|SUPERIORITY||Mean Difference (Net)|1.15||||0.286|TWO_SIDED||||||ANOVA|degrees of freedom = 1, 118||As-treated analyses||||0.286
72418330|NCT03382782|144347150|SUPERIORITY||Mean Difference (Net)|1.36||||0.261|TWO_SIDED||||||ANOVA|degrees of freedom = 2, 182||Intent-to-treat analyses||||0.261
72418331|NCT03382782|144347150|SUPERIORITY||Mean Difference (Net)|0.012||||0.912|TWO_SIDED||||||ANOVA|degrees of freedom = 1, 118||As-treated analyses||||0.912
72418332|NCT03382782|144347152|SUPERIORITY||Mean Difference (Net)|1.74||||0.11|TWO_SIDED||||||ANOVA|degrees of freedom = 3, 172||||||0.11
72610893|NCT00316004|144750531|SUPERIORITY_OR_OTHER|||||||0.04||95.0||||The p-value was not adjusted for multiple comparisons. Test compares proportions across all three treatment groups.|test for differences in proportions|||The null hypothesis is that there are no differences in the percent of patients with bloodstream infections through hospital stay between the three groups.||||0.04
72610894|NCT00316004|144750531|SUPERIORITY_OR_OTHER|||||||0.06||95.0||||The p-value was not adjusted for multiple comparisons. Test compares proportions across all three treatment groups.|test for differences in proportions|||The null hypothesis is that there are no differences in the percent of patients with urinary tract infections through hospital stay between the three groups.||||0.06
72610895|NCT00316004|144750531|SUPERIORITY_OR_OTHER|||||||0.88||95.0||||The p-value was not adjusted for multiple comparisons. Test compares proportions across all three treatment groups.|test for differences in proportions|||The null hypothesis is that there are no differences in the percent of patients with wound infections through hospital stay between the three groups.||||0.88
72610896|NCT00316004|144750532|SUPERIORITY_OR_OTHER|||||||0.68||95.0||||The p-value was not adjusted for multiple comparisons. Test compares averages across all three treatment groups.|ANOVA|||The null hypothesis is that there are no differences in the average amount of total fluids given within the first 24 hours between the three groups.||||0.68
72610897|NCT00316004|144750533|SUPERIORITY_OR_OTHER|||||||0.43||95.0||||The p-value was not adjusted for multiple comparisons. Test compares averages across all three treatment groups.|ANOVA|||The null hypothesis is that there are no differences in the average number of PRBC units given within the first 24 hours between the three groups.||||0.43
72610898|NCT00316004|144750534|SUPERIORITY_OR_OTHER|||||||0.88||95.0||||The p-value was not adjusted for multiple comparisons. Test compares proportions across all three treatment groups.|test for proportions|||The null hypothesis is that there are no differences in the percent of patients who died during hospitalization between the three groups.||||0.88
72610899|NCT00316004|144750534|SUPERIORITY_OR_OTHER|||||||0.26||95.0||||The p-value was not adjusted for multiple comparisons. Test compares proportions across all three treatment groups.|test for differences in proportions|||The null hypothesis is that there are no differences in the percent of patients who were discharged alive from the hospital to home between the three groups.||||0.26
72418333|NCT03382782|144347153|SUPERIORITY||Mean Difference (Net)|1.18||||0.09|TWO_SIDED||||||ANOVA|degrees of freedom = 3, 156||Mean systolic blood pressure||||0.09
72418334|NCT03382782|144347153|SUPERIORITY||Mean Difference (Net)|0.63||||0.05|TWO_SIDED||||||ANOVA|degrees of freedom = 3, 156||Mean diastolic blood pressure||||0.05
72418335|NCT03382782|144347155|SUPERIORITY|Intention-to-treat analyses. General Health subscale.|Mean Difference (Net)|2.14||||0.121|TWO_SIDED||||||ANOVA|degrees of freedom = 2, 182||||||0.121
72610900|NCT00316004|144750534|SUPERIORITY_OR_OTHER|||||||0.16||95.0||||The p-value was not adjusted for multiple comparisons. Test compares proportions across all three treatment groups.|test for differences in proportions|||The null hypothesis is that there are no differences in the percent of patients who were discharged alive from the hospital to inpatient rehabilitation facilities between the three groups.||||0.16
72610901|NCT00316004|144750534|SUPERIORITY_OR_OTHER|||||||0.17||95.0||||The p-value was not adjusted for multiple comparisons. Test compares proportions across all three treatment groups.|test for differences in proportions|||The null hypothesis is that there are no differences in the percent of patients who were discharged alive from the hospital to skilled nursing facilities between the three groups.||||0.17
72418336|NCT03382782|144347155|SUPERIORITY||Mean Difference (Net)|1.71||||0.193|TWO_SIDED||||||ANOVA|degrees of freedom = 1, 118||As-treated analyses. General Health subscale.||||0.193
72418337|NCT03382782|144347155|SUPERIORITY||Mean Difference (Net)|0.181||||0.835|TWO_SIDED||||||ANOVA|degrees of freedom = 2, 182||Intention-to-treat analyses. Bodily Pain subscale.||||0.835
72418338|NCT03382782|144347155|SUPERIORITY||Mean Difference (Net)|0.43||||0.513|TWO_SIDED||||||ANOVA|degrees of freedom = 1, 118||As-treated analyses, Bodily Pain subscale.||||0.513
72418339|NCT03382782|144347155|SUPERIORITY||Mean Difference (Net)|2.37||||0.097|TWO_SIDED||||||ANOVA|degrees of freedom = 2, 182||Intention-to-treat analyses, Physical Functioning subscale.||||0.097
72610902|NCT00977197|144750535|SUPERIORITY_OR_OTHER|||||||0.008|||||||ANCOVA|Intent to Treat analysis; adjusted for age and gender.||||||0.008
72610903|NCT00977197|144750536|SUPERIORITY_OR_OTHER|||||||0.009|||||||ANCOVA|Intent to Treat analysis; adjusted for age and gender.||||||0.009
72610904|NCT00977197|144750537|SUPERIORITY_OR_OTHER|||||||0.389|||||||ANCOVA|Intent to Treat analysis; adjusted for age and gender; rank scale.||||||0.389
72610905|NCT00977197|144750538|SUPERIORITY_OR_OTHER|||||||0.049|||||||ANCOVA|Intent to Treat analysis; adjusted for age and gender, rank scale.||||||0.049
72418340|NCT03382782|144347155|SUPERIORITY||Mean Difference (Net)|0.04||||0.184|TWO_SIDED||||||ANOVA|degrees of freedom = 1, 118||As-treated analyses, Physical Functioning subscale.||||0.184
72326269|NCT02722408|144175866|OTHER|||||||0.0033||||||Mixed-effects model for repeated measures analysis with percent change in TC as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84 (Defective LDLr)||||0.0033
72326270|NCT02722408|144175866|OTHER|||||||0.0618||||||Mixed-effects model for repeated measures analysis with percent change in TC as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28 (Met EAS Clinical Diagnosis of HoFH)||||0.0618
72326271|NCT02722408|144175866|OTHER|||||||0.0298||||||Mixed-effects model for repeated measures analysis with percent change in TC as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56 (Met EAS Clinical Diagnosis of HoFH)||||0.0298
72326272|NCT02722408|144175866|OTHER|||||||0.0352||||||Mixed-effects model for repeated measures analysis with percent change in TC as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84 (Met EAS Clinical Diagnosis of HoFH)||||0.0352
72326273|NCT02722408|144175866|OTHER|||||||0.0001||||||Mixed-effects model for repeated measures analysis with percent change in TC as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28 (Not Met EAS Clinical Diagnosis of HoFH)||||0.0001
72418341|NCT03382782|144347155|SUPERIORITY||Mean Difference (Net)|1.06||||0.347|TWO_SIDED||||||ANOVA|degrees of freedom = 2, 182||Intention-to-treat analyses. Emotional Well-Being subscale.||||0.347
72418342|NCT03382782|144347155|SUPERIORITY||Mean Difference (Net)|0.361||||0.549|TWO_SIDED||||||ANOVA|degrees of freedom = 1, 118||As-treated analyses, Emotional Well-Being subscale.||||0.549
72418343|NCT03382782|144347156|SUPERIORITY||Mean Difference (Net)|0.157||||0.855|TWO_SIDED||||||ANOVA|Degrees of freedom = 2,182||Intention-to-treat analyses||||.855
72326274|NCT02722408|144175866|OTHER||||||<|0.0001||||||Mixed-effects model for repeated measures analysis with percent change in TC as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56 (Not Met EAS Clinical Diagnosis of HoFH)||||<0.0001
72326275|NCT02722408|144175866|OTHER||||||<|0.0001||||||Mixed-effects model for repeated measures analysis with percent change in TC as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84 (Not Met EAS Clinical Diagnosis of HoFH)||||<0.0001
72326276|NCT02722408|144175867|OTHER|||||||0.3672||||||Mixed-effects model for repeated measures analysis with change in TC as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28 (Negative LDLr||||0.3672
72326277|NCT02722408|144175867|OTHER|||||||0.2101||||||Mixed-effects model for repeated measures analysis with change in TC as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56 (Negative LDLr)||||0.2101
72326278|NCT02722408|144175867|OTHER|||||||0.3009||||||Mixed-effects model for repeated measures analysis with change in TC as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84 (Negative LDLr)||||0.3009
72326279|NCT02722408|144175867|OTHER|||||||0.1567||||||Mixed-effects model for repeated measures analysis with change in TC as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28 (Defective LDLr)||||0.1567
72326280|NCT02722408|144175867|OTHER|||||||0.1207||||||Mixed-effects model for repeated measures analysis with change in TC as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56 (Defective LDLr)||||0.1207
72326281|NCT02722408|144175867|OTHER|||||||0.1045||||||Mixed-effects model for repeated measures analysis with change in TC as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84 (Defective LDLr)||||0.1045
72326282|NCT02722408|144175867|OTHER|||||||0.0631||||||Mixed-effects model for repeated measures analysis with change in TC as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28 (Met EAS Clinical Diagnosis of HoFH)||||0.0631
72326283|NCT02722408|144175867|OTHER|||||||0.0217||||||Mixed-effects model for repeated measures analysis with change in TC as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56 (Met EAS Clinical Diagnosis of HoFH)||||0.0217
72418344|NCT03382782|144347156|SUPERIORITY||Mean Difference (Net)|0.011||||0.915|TWO_SIDED||||||ANOVA|degrees of freedom = 1, 118||As-treated analyses||||0.915
72418345|NCT03382782|144347158|SUPERIORITY||Mean Difference (Net)|0.68||||0.508|TWO_SIDED||||||ANOVA|degrees of freedom = 2, 182||Intent-to-treat analyses||||0.508
72418346|NCT03382782|144347158|SUPERIORITY||Mean Difference (Net)|1.67||||0.198|TWO_SIDED||||||ANOVA|degrees of freedom = 1, 118||As-treated analyses||||0.198
72326284|NCT02722408|144175867|OTHER|||||||0.0359||||||Mixed-effects model for repeated measures analysis with change in TC as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84 (Met EAS Clinical Diagnosis of HoFH)||||0.0359
72326285|NCT02722408|144175867|OTHER|||||||0.0001||||||Mixed-effects model for repeated measures analysis with change in TC as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28 (Not Met EAS Clinical Diagnosis of HoFH)||||0.0001
72418347|NCT01316510|144347160|SUPERIORITY_OR_OTHER||||||<|0.01|||||||t-test, 2 sided|||Primary outcome (percentage of bifidobacteria in the final stool specimen)||||<0.01
72418348|NCT01316510|144347161|SUPERIORITY_OR_OTHER|||||||0.44|||||||t-test, 2 sided|||Secondary outcome (length of hospital stay) for all 24 infants (this included two infants with intestinal atresia, both in the placebo group)||||0.44
72610906|NCT00977197|144750539|SUPERIORITY_OR_OTHER|||||||0.044|||||||ANCOVA|Intent to Treat analysis; adjusted for age and gender.||||||0.044
72418349|NCT00428090|144347162|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.8||||0.074|TWO_SIDED|95.0|-3.8|0.2||Comparison between Placebo and RSG XR 2 mg in APOE e4 neg cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||0.2|-3.8|0.074
72418350|NCT00428090|144347162|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0||||0.338|TWO_SIDED|95.0|-3.0|1.0||Comparison between Placebo and RSG XR 8 mg in APOE e4 neg cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||1.0|-3.0|0.338
72418351|NCT00428090|144347162|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7||||0.602|TWO_SIDED|95.0|-3.5|2.1||Comparison between Placebo and Donepezil 10mg in APOE e4 neg cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||2.1|-3.5|0.602
72418352|NCT00428090|144347163|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.2||||0.131|TWO_SIDED|95.0|-2.7|0.4||Comparison between Placebo and RSG XR 2 mg in All except e4/e4's cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||0.4|-2.7|0.131
72418353|NCT00428090|144347163|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8||||0.315|TWO_SIDED|95.0|-2.4|0.8||Comparison between Placebo and RSG XR 8 mg in All except e4/e4's cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||0.8|-2.4|0.315
72418354|NCT00428090|144347163|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.6||||0.105|TWO_SIDED|95.0|-3.5|0.3||Comparison between Placebo and Donepezil 10 mg in All except e4/e4's cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||0.3|-3.5|0.105
72418355|NCT00428090|144347164|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8||||0.272|TWO_SIDED|95.0|-2.2|0.6||Comparison between Placebo and RSG XR 2 mg in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||0.6|-2.2|0.272
72418356|NCT00428090|144347164|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8||||0.297|TWO_SIDED|95.0|-2.2|0.7||Comparison between Placebo and RSG XR 8 mg in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||0.7|-2.2|0.297
72418357|NCT00428090|144347164|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.3||||0.131|TWO_SIDED|95.0|-3.1|0.4||Comparison between Placebo and Donepezil 10 mg in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix||||0.4|-3.1|0.131
72418358|NCT00428090|144347165|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||0.663|TWO_SIDED|95.0|-0.3|0.4||Comparison between Placebo and RSG XR 2 mg in APOE e4 neg cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||0.4|-0.3|0.663
72418359|NCT00428090|144347165|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.891|TWO_SIDED|95.0|-0.4|0.3||Comparison between Placebo and RSG XR 8 mg in APOE e4 neg cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||0.3|-0.4|0.891
72610907|NCT00977197|144750540|SUPERIORITY_OR_OTHER|||||||0.35||||||Intent to treat analysis, not adjusted for age and gender.|Chi-squared|||||||0.350
72610908|NCT00977197|144750541|SUPERIORITY_OR_OTHER|||||||0.02|||||||ANCOVA|Intent to Treat analysis; adjusted for age and gender, rank scale.||||||0.020
72610909|NCT00977197|144750542|SUPERIORITY_OR_OTHER|||||||0.024|||||||ANCOVA|Intent to Treat analysis; adjusted for age and gender.||||||0.024
72610910|NCT00977197|144750543|SUPERIORITY_OR_OTHER|||||||0.417|||||||ANCOVA|Intent to Treat analysis; adjusted for age and gender, rank scale.||||||0.417
72610911|NCT00977197|144750544|SUPERIORITY_OR_OTHER|||||||0.03||||||Intent to Treat analysis; adjusted for age and gender, rank scale.|ANCOVA|||||||0.030
72610912|NCT00977197|144750545|SUPERIORITY_OR_OTHER|||||||0.016|||||||ANCOVA|Intent to Treat analysis; adjusted for age and gender.||||||0.016
72326286|NCT02722408|144175867|OTHER||||||<|0.0001||||||Mixed-effects model for repeated measures analysis with change in TC as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56 (Not Met EAS Clinical Diagnosis of HoFH)||||<0.0001
72610913|NCT00977197|144750546|SUPERIORITY_OR_OTHER|||||||0.097||||||Intent to Treat analysis; not adjusted for age and gender.|Chi-squared|||||||0.097
72610914|NCT02842866|144750572|NON_INFERIORITY|The 95 percent (%) confidence internal (CI) of the difference in percentage was computed using the Wilson Score method without continuity correction. The overall non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI was greater than (\>) -10 percent (%) for all four serogroups.|Difference in percentage|15.7|||||TWO_SIDED|95.0|9.08|22.2||||||Serogroup A||22.2|9.08|
72610915|NCT02842866|144750572|NON_INFERIORITY|The 95% CI of the difference in percentage was computed using the Wilson Score method without continuity correction. The overall non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI was \>-10% for all four serogroups.|Difference in percentage|27.5|||||TWO_SIDED|95.0|21.2|33.5||||||Serogroup C||33.5|21.2|
72610916|NCT02842866|144750572|NON_INFERIORITY|The 95% CI of the difference in percentage was computed using the Wilson Score method without continuity correction. The overall non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI was \>-10% for all four serogroups.|Difference in percentage|31.0|||||TWO_SIDED|95.0|24.6|37.0||||||Serogroup Y||37.0|24.6|
72610917|NCT02842866|144750572|NON_INFERIORITY|The 95% CI of the difference in percentage was computed using the Wilson Score method without continuity correction. The overall non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI was \>-10% for all four serogroups.|Difference in percentage|17.8|||||TWO_SIDED|95.0|11.2|24.2||||||Serogroup W||24.2|11.2|
72610918|NCT02842866|144750573|OTHER||GMT Ratio|1.75|||||TWO_SIDED|95.0|1.4|2.2||||||Serogroup A||2.20|1.40|
72610919|NCT02842866|144750573|OTHER||GMT Ratio|4.1|||||TWO_SIDED|95.0|3.16|5.33||||||Serogroup C||5.33|3.16|
72610920|NCT02842866|144750573|OTHER||GMT Ratio|3.3|||||TWO_SIDED|95.0|2.57|4.23||||||Serogroup Y||4.23|2.57|
72610921|NCT02842866|144750573|OTHER||GMT Ratio|1.81|||||TWO_SIDED|95.0|1.42|2.31||||||Serogroup W||2.31|1.42|
72610922|NCT00676143|144750574|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.02||||0.979|TWO_SIDED|95.0|-1.18|1.22||Primary variable ADAS-Cog/11 total score had to reach statistical significance, p-values had to reach p \<=0.05, in order to be declared effective.|Mixed Models Analysis|||"Change in ADAS-Cog/11 total score was analyzed using a restricted maximum likelihood-based mixed model for repeated measures.~The number of participants in each group gave 90% power to detect a 2.21 point advantage for the bapineuzumab group over placebo on the ADAS-Cog/11 total score, at the primary time point (Week 78). This calculation was based on a two-sided test with an alpha of 0.05."||1.22|-1.18|0.979
72610923|NCT00676143|144750575|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.04||||0.973|TWO_SIDED|95.0|-2.51|2.6||Primary variable DAD total score had to reach statistical significance, p-values had to reach p \<=0.05, in order to be declared effective.|Mixed Models Analysis|||"Change in DAD total score was analyzed using a restricted maximum likelihood-based mixed model for repeated measures.~The number of participants in each group gave 90% power to detect a 5.39 unit advantage for the bapineuzumab group over placebo on the DAD total score, at the primary time point (Week 78). This calculation was based on a two-sided test with an alpha of 0.05."||2.60|-2.51|0.973
72610924|NCT00676143|144750576|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.07||||0.159|TWO_SIDED|95.0|-0.17|0.03|||Mixed Models Analysis|||"Change in PIB PET SUVr was analyzed using a restricted maximum likelihood-based mixed model for repeated measures.~The number of participants gave 90% power to detect a 0.152 unit advantage for the bapineuzumab group over placebo for PiB PET binding at Week 71. The calculations were based on 2-sided tests with alpha set at 0.05."||0.03|-0.17|0.159
72610925|NCT00676143|144750577|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.38||||0.62|TWO_SIDED|95.0|-6.89|4.13|||ANCOVA|||Change in CSF phospho-tau was analyzed using an analysis of covariance (ANCOVA) model. The analysis was based on the treatment difference estimated at Week 71 based on appropriate contrasts or LS means. The number of participants gave 90% power to detect a 13-ng/L advantage in phospho-tau for the bapineuzumab group over placebo at Week 71. The calculations were based on 2-sided tests with alpha set at 0.05.||4.13|-6.89|0.620
72610926|NCT00676143|144750578|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.13||||0.884|TWO_SIDED|95.0|-1.89|1.63|||Mixed Models Analysis|||"Change in MRI BBSI was analyzed using a restricted maximum likelihood-based mixed model for repeated measures.~The number of participants gave 90% power to detect a 4.15-cm3 advantage for the bapineuzumab group over placebo on reduction in brain volume as measured by the BBSI at Week 71. The calculations were based on 2-sided tests with alpha set at 0.05."||1.63|-1.89|0.884
72610927|NCT00676143|144750579|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.24||||0.7|TWO_SIDED|95.0|-0.97|1.45|||Mixed Models Analysis|||Treatment Difference: Bapineuzumab - Placebo||1.45|-0.97|0.700
72610928|NCT00676143|144750580|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.09||||0.949|TWO_SIDED|95.0|-2.61|2.78|||Mixed Models Analysis|||Treatment Difference: Bapineuzumab - Placebo||2.78|-2.61|0.949
72610929|NCT00676143|144750581|SUPERIORITY_OR_OTHER|||||||0.684|||||||Log Rank|||||||0.684
72610930|NCT00676143|144750582|SUPERIORITY_OR_OTHER|||||||0.383|||||||Log Rank|||||||0.383
72610931|NCT00676143|144750583|SUPERIORITY_OR_OTHER|||||||0.191|||||||Log Rank|||||||0.191
72610932|NCT00676143|144750584|SUPERIORITY_OR_OTHER|||||||0.478|||||||Log Rank|||||||0.478
72610933|NCT00676143|144750585|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.11||||0.462|TWO_SIDED|95.0|-0.41|0.13|||Mixed Models Analysis|||Change in DS total score was analyzed using a restricted maximum likelihood-based mixed model for repeated measures.||0.13|-0.41|0.462
72610934|NCT00676143|144750587|SUPERIORITY_OR_OTHER|||||||0.086|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.086
72326287|NCT02722408|144175867|OTHER||||||<|0.0001||||||Mixed-effects model for repeated measures analysis with change in TC as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84 (Not Met EAS Clinical Diagnosis of HoFH)||||<0.0001
72610935|NCT00676143|144750589|SUPERIORITY_OR_OTHER|||||||0.12|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.120
72610936|NCT00676143|144750590|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.15||||0.448|TWO_SIDED|95.0|-0.55|0.24|||Mixed Models Analysis|||Change in CDR-SOB total score was analyzed using a restricted maximum likelihood-based mixed model for repeated measures.||0.24|-0.55|0.448
72610937|NCT02309359|144750610|OTHER|Under the assumption of monotonicity, a Cochran-Armitage trend test was performed as the primary efficacy analysis. Data were analyzed according to the intent-to-treat (ITT) principle; thus, subjects were analyzed according to the treatment to which they were assigned. Subjects with missing ACR20 response at Week 12 were treated as non responders (non responder imputation approach).||||||0.172|||||||Cochran-Armitage trend test|||The null hypothesis of this test was that there is no difference in the percentage of subjects achieving ACR20 response between the treatment groups and the alternative hypothesis was that the percentage of subjects achieving ACR20 response increases with increasing dose level.||||0.172
72610938|NCT00701363|144750638|SUPERIORITY_OR_OTHER|||||||0.0013|TWO_SIDED||||||ANCOVA|||One subject (Group B) had missing IGF-1 value at Week 48. One subject (Group A) had missing IGF-1 value at Baseline.||||0.0013
72610939|NCT00701363|144750638|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|||||||<0.0001
72610940|NCT00701363|144750638|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|||||||<0.0001
72610941|NCT00701363|144750639|SUPERIORITY_OR_OTHER|||||||0.0009|TWO_SIDED||||||t-test, 2 sided|||||||0.0009
72418360|NCT00428090|144347165|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2||||0.414|TWO_SIDED|95.0|-0.7|0.3||Comparison between Placebo and Donepezil 10 mg in APOE e4 neg cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|||0.3|-0.7|0.414
72418361|NCT00428090|144347166|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.913|TWO_SIDED|95.0|-0.3|0.3||Comparison between Placebo and RSG XR 2 mg in All except e4/e4's cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix||||0.3|-0.3|0.913
72418362|NCT00428090|144347166|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.276|TWO_SIDED|95.0|-0.4|0.1||Comparison between Placebo and RSG XR 8 mg in All except e4/e4's cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||0.1|-0.4|0.276
72418363|NCT00428090|144347166|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5||||0.025|TWO_SIDED|95.0|-0.8|-0.1||Comparison between Placebo and Donepezil 10 mg in All except e4/e4's cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||-0.1|-0.8|0.025
72418364|NCT00428090|144347167|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.939|TWO_SIDED|95.0|-0.2|0.3||Comparison between Placebo and RSG XR 2 mg in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||0.3|-0.2|0.939
72418365|NCT00428090|144347167|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.307|TWO_SIDED|95.0|-0.4|0.1||Comparison between Placebo and RSG XR 8 mg in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||0.1|-0.4|0.307
72610942|NCT00701363|144750639|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||t-test, 2 sided|||||||<0.0001
72326288|NCT02722408|144175868|OTHER|||||||0.9417||||||Mixed-effects model for repeated measures analysis with percent change in TG as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28 (Negative LDLr)||||0.9417
72418366|NCT00428090|144347167|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5||||0.009|TWO_SIDED|95.0|-0.8|-0.1||Comparison between Placebo and Donepezil 10 mg in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||-0.1|-0.8|0.009
72418367|NCT00428090|144347168|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9||||0.116|TWO_SIDED|95.0|-2.0|0.2||Comparison between Placebo and RSG XR 2 mg at Week 8 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||0.2|-2.0|0.116
72418368|NCT00428090|144347168|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||0.816|TWO_SIDED|95.0|-0.9|1.2||Comparison between Placebo and RSG XR 8 mg at Week 8 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||1.2|-0.9|0.816
72610943|NCT00701363|144750639|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||t-test, 2 sided|||||||<0.0001
72610944|NCT00701363|144750639|SUPERIORITY_OR_OTHER|||||||0.017|TWO_SIDED||||||t-test, 2 sided|||||||0.0170
72610945|NCT00701363|144750640|SUPERIORITY_OR_OTHER|||||||0.0103|TWO_SIDED||||||t-test, 2 sided|||Difference in baseline IGF-1 levels between 108 subjects with normalized IGF-1 levels at week 24 (A+B+C) and 14 subjects with uncontrolled IGF-1 levels at week 24.||||0.0103
72610946|NCT00284856|144750649|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|5.92||||||95.0|0.28|11.56|||||Estimated Value is difference in least squares mean (montelukast - placebo)|||11.56|0.28|
72610947|NCT00284856|144750649|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|10.14||||||95.0|4.5|15.78|||||Estimated value is difference in least squares mean (fluticasone - placebo)|||15.78|4.50|
72610948|NCT00284856|144750649|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-4.22||||||95.0|-9.83|1.38|||||Estimated value is difference in least squares mean (montelukast - fluticasone)|||1.38|-9.83|
72326289|NCT02722408|144175868|OTHER|||||||0.7722||||||Mixed-effects model for repeated measures analysis with percent change in TG as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56 (Negative LDLr)||||0.7722
72326290|NCT02722408|144175868|OTHER|||||||0.5283||||||Mixed-effects model for repeated measures analysis with percent change in TG as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84 (Negative LDLr)||||0.5283
72610949|NCT00284856|144750650|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.15||||||95.0|-0.25|-0.05|||||Estimated value is difference in least squares mean (montelukast - placebo)|||-0.05|-0.25|
72610950|NCT00284856|144750650|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.2||||||95.0|-0.3|-0.1|||||Estimated value is difference in least squares mean (fluticasone - placebo)|||-0.10|-0.30|
72610951|NCT00284856|144750650|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|0.05||||||95.0|-0.05|0.15|||||Estimated value is difference in least squares mean (montelukast - fluticasone)|||0.15|-0.05|
72610952|NCT00284856|144750651|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|5.09||||||95.0|-1.27|11.45|||||Estimated value is difference in least squares mean (montelukast - placebo)|||11.45|-1.27|
72610953|NCT00284856|144750651|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|11.21||||||95.0|4.85|17.58|||||Estimated value is difference in least squares mean (fluticasone - placebo)|||17.58|4.85|
72418369|NCT00428090|144347168|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7||||0.318|TWO_SIDED|95.0|-2.1|0.7||Comparison between Placebo and Donepezil 10 mg at Week 8 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||0.7|-2.1|0.318
72418370|NCT00428090|144347168|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||0.839|TWO_SIDED|95.0|-1.1|1.3||Comparison between Placebo and RSG XR 2 mg in at Week 16 Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||1.3|-1.1|0.839
72418371|NCT00428090|144347168|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.8||||0.165|TWO_SIDED|95.0|-0.3|2.0||Comparison between Placebo and RSG XR 8 mg at Week 16 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||2.0|-0.3|0.165
72418372|NCT00428090|144347168|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.6||||0.073|TWO_SIDED|95.0|-3.4|0.2||Comparison between Placebo and Donepezil 10 mg at Week 16 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||0.2|-3.4|0.073
72418373|NCT00428090|144347168|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8||||0.272|TWO_SIDED|95.0|-2.2|0.6||Comparison between Placebo and RSG XR 2 mg at Week 24 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||0.6|-2.2|0.272
72418374|NCT00428090|144347168|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8||||0.297|TWO_SIDED|95.0|-2.2|0.7||Comparison between Placebo and RSG XR 8 mg at Week 24 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||0.7|-2.2|0.297
72418375|NCT00428090|144347168|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.3||||0.131|TWO_SIDED|95.0|-3.1|0.4||Comparison between Placebo and Donepezil 10 mg at Week 24 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||0.4|-3.1|0.131
72418376|NCT00428090|144347169|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.133|TWO_SIDED|95.0|-0.3|0.0||Comparison between Placebo and RSG XR 2 mg at Week 8 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||0.0|-0.3|0.133
72418377|NCT00428090|144347169|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.958|TWO_SIDED|95.0|-0.2|0.2||Comparison between Placebo and RSG XR 8 mg at Week 8 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||0.2|-0.2|0.958
72418378|NCT00428090|144347169|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2||||0.085|TWO_SIDED|95.0|-0.5|0.0||Comparison between Placebo and Donepezil 10 mg at Week 8 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||0.0|-0.5|0.085
72418379|NCT00428090|144347169|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2||||0.102|TWO_SIDED|95.0|-0.4|0.0||Comparison between Placebo and RSG XR 2 mg at Week 16 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||0.0|-0.4|0.102
72418380|NCT00428090|144347169|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.38|TWO_SIDED|95.0|-0.3|0.1||Comparison between Placebo and RSG XR 8 mg at Week 16 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||0.1|-0.3|0.380
72418381|NCT00428090|144347169|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4||||0.006|TWO_SIDED|95.0|-0.7|-0.1||Comparison between Placebo and Donepezil 10 mg at Week 16 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||-0.1|-0.7|0.006
72418382|NCT00428090|144347169|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.939|TWO_SIDED|95.0|-0.2|0.3||Comparison between Placebo and RSG XR 2 mg at Week 24 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||0.3|-0.2|0.939
72610954|NCT00284856|144750651|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-6.13||||||95.0|-12.46|0.2|||||Estimated value is difference in least squares mean (montelukast - fluticasone)|||0.20|-12.46|
72610955|NCT01654276|144750681|SUPERIORITY_OR_OTHER_LEGACY|||||||0.66|TWO_SIDED||||||t-test, 2 sided|||||||0.66
72610956|NCT04609514|144750689|SUPERIORITY||Median Difference (Final Values)|10.95||||0.51|TWO_SIDED||||||Wilcoxon Rank Sum Test|||||||0.51
72610957|NCT04609514|144750690|SUPERIORITY||||||<|0.001|||||||Wilcoxon Rank Sum Test|||||||<0.001
72326291|NCT02722408|144175868|OTHER|||||||0.5905||||||Mixed-effects model for repeated measures analysis with percent change in TG as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28 (Defective LDLr)||||0.5905
72418383|NCT00428090|144347169|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.307|TWO_SIDED|95.0|-0.4|0.1||Comparison between Placebo and RSG XR 8 mg at Week 24 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||0.1|-0.4|0.307
72418384|NCT00428090|144347169|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5||||0.009|TWO_SIDED|95.0|-0.8|-0.1||Comparison between Placebo and Donepezil 10 mg at Week 24 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||-0.1|-0.8|0.009
72610958|NCT04609514|144750695|SUPERIORITY|||||||0.39||||||A robust Yuen's test was conducted with an apriori threshold of 0.05 for statistical significance. No covariates were introduced in the model.|Robust Yuen's test|||||||0.39
72326292|NCT02722408|144175868|OTHER|||||||0.7682||||||Mixed-effects model for repeated measures analysis with percent change in TG as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56 (Defective LDLr)||||0.7682
72326293|NCT02722408|144175868|OTHER|||||||0.9245||||||Mixed-effects model for repeated measures analysis with percent change in TG as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84 (Defective LDLr)||||0.9245
72610959|NCT04609514|144750696|SUPERIORITY|||||||0.4|||||||Robust Yuen's test|||||||0.40
72610960|NCT04609514|144750697|SUPERIORITY|||||||0.478|||||||Wilcoxon rank sum test|Wilcoxon rank sum test with continuity correction.||||||0.478
72610961|NCT04609514|144750698|SUPERIORITY|||||||0.51|||||||Wilcoxon rank sum test|Wilcoxon rank sum test with continuity correction.||||||0.51
72610962|NCT04609514|144750700|SUPERIORITY||Odds Ratio (OR)|1.185||||0.8392|TWO_SIDED|95.0|0.23|6.119|||Regression, Logistic|||||6.119|0.23|0.8392
72610963|NCT04609514|144750701|SUPERIORITY|||||||1|||||||Pearson's Chi-squared test|Pearson's Chi-squared test with Yates' continuity correction.||||||1.00
72610964|NCT00402831|144750715|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was declared when the lower bounds of the 95% confidence interval (CI) of the group difference in response rates was greater than -10%.|Mean Difference (Final Values)|0.0|||||TWO_SIDED|95.0|-2.5|2.6||||||Measles difference||2.6|-2.5|
72610965|NCT00402831|144750715|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was declared when the lower bounds of the 95% confidence interval (CI) of the group difference in response rates was greater than -10%.|Mean Difference (Final Values)|0.1|||||TWO_SIDED|95.0|-3.0|3.3||||||Mumps difference||3.3|-3.0|
72610966|NCT00402831|144750715|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was declared when the lower bounds of the 95% confidence interval (CI) of the group difference in response rates was greater than -10%.|Mean Difference (Final Values)|0.7|||||TWO_SIDED|95.0|-2.3|4.1||||||Rubella difference||4.1|-2.3|
72610967|NCT00402831|144750715|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was declared when the lower bounds of the 95% confidence interval (CI) of the group difference in response rates was greater than -10%.|Mean Difference (Final Values)|0.7|||||TWO_SIDED|95.0|-2.1|4.1||||||Varicella||4.1|-2.1|
72610968|NCT03043053|144750728|OTHER||Mean Difference (Final Values)|-0.06|||||TWO_SIDED|95.0|-1.4|1.3||||||||1.3|-1.4|
72610969|NCT03043053|144750729|OTHER||Mean Difference (Final Values)|-29.7|||||TWO_SIDED|95.0|-141.9|82.6|||||Controlled for lean mass. Reported values are outputted by STATA.|||82.6|-141.9|
72610970|NCT03043053|144750730|OTHER||Mean Difference (Final Values)|196.0|||||TWO_SIDED|95.0|-1036.0|1428.0||||||||1428|-1036|
72610971|NCT03043053|144750731|OTHER||Mean Difference (Final Values)|-152.0|||||TWO_SIDED|95.0|-302.3|-1.7||||||||-1.7|-302.3|
72610972|NCT03699748|144750751|OTHER||Mean Difference (Net)|10.92|||<|0.001|TWO_SIDED|95.0|7.27|14.58|||Type III F test|||||14.58|7.27|<0.001
72610973|NCT03699748|144750754|OTHER||Effect Estimate for 4 Months|12.88|||||TWO_SIDED||||||||12.88 (9.49 - 16.28)||Effect estimates were expected mean differences in Patient Activation Measure scores between groups from baseline. Effect estimates were estimated using generalized estimating equations (GEE) models as a function of treatment group, categorical time (baseline, 4 months and 12 months), and an interaction term between treatment group and time with an exchangeable correlation clustered within person. The effect estimate column shows the difference between change in the intervention group from baseline and the change in the control group from baseline.|||
72610974|NCT03699748|144750755|OTHER||Effect Estimate for 12 Months|20.65|||||TWO_SIDED||||||||20.65 (6.97 - 24.32)||Effect estimates were expected mean differences in Patient Activation Measure scores between groups from baseline. Effect estimates were estimated using generalized estimating equations (GEE) models as a function of treatment group, categorical time (baseline, 4 months and 12 months), and an interaction term between treatment group and time with an exchangeable correlation clustered within person.|||
72610975|NCT03699748|144750756|OTHER||Median Difference (Net)|11.05||||0.001|TWO_SIDED|95.0|7.09|15.0|||Type III F-test|||||15.00|7.09|0.001
72610976|NCT03699748|144750758|OTHER||Odds Ratio (OR)|0.91|||||TWO_SIDED||||||||0.91 (0.40-2.09)||Odds Ratios for any emergency room use and any hospitalization use were estimated using logistic regression models.|||
72610977|NCT03699748|144750759|OTHER||Odds Ratio (OR)|0.27|||||TWO_SIDED||||||||0.27 (0.03 - 2.85)||Odds Ratios for any ED Use were estimated using logistic regression models.|||
72610978|NCT03699748|144750760|OTHER||Odds Ratio (OR)|0.38|||||TWO_SIDED||||||||0.38 (0.18-0.76)||Odds Ratios for any emergency room use and any hospitalization use were estimated using logistic regression models.|||
72610979|NCT03699748|144750761|OTHER||Odds Ratio (OR)|0.42|||||TWO_SIDED||||||||0.42 (0.22-0.79)||Odds Ratios for any emergency room use and any hospitalization use were estimated using logistic regression models.|||
72610980|NCT03699748|144750762|OTHER||Odds Ratio (OR)|0.38|||||TWO_SIDED||||||||0.38 (0.08-1.75)||Odds Ratios for Hospitalization Use were estimated using logistic regression models.|||
72610981|NCT03699748|144750763|OTHER||Odds Ratio, log|5.86|||||TWO_SIDED||||||||Odds Ratios for Goals of Care Documentation, Advance Directive Documentation, and Physician Order for Life Sustaining Treatment Documentation were estimated based on assessments 4-months and 12-months post-enrollment with logistic regression.|||||
72610982|NCT03699748|144750764|OTHER||Odds Ratio (OR)|4.09|||||TWO_SIDED||||||||Odds Ratios for Goals of Care Documentation, Advance Directive Documentation, and Physician Order for Life Sustaining Treatment Documentation were estimated based on assessments 4-months and 12-months post-enrollment with logistic regression.|||||
72610983|NCT03699748|144750765|OTHER||Odds Ratio (OR)|6.82|||||TWO_SIDED||||||||6.82 (2.46-18.93)||Odds Ratios for Physician Order for Life Sustaining Treatment Documentation were estimated based on assessments 4-months post-enrollment with logistic regression.|||
72610984|NCT03699748|144750766|OTHER||Odds Ratio (OR)|3.62|||||TWO_SIDED||||||||3.62 (1.73-7.60)||Odds Ratios for Physician Order for Life Sustaining Treatment Documentation were estimated based on assessments at 12-months post-enrollment with logistic regression.|||
72610985|NCT03699748|144750767|OTHER||Odds Ratio, log|8.56|||||TWO_SIDED||||||||Odds Ratios for Goals of Care Documentation, Advance Directive Documentation, and Physician Order for Life Sustaining Treatment Documentation were estimated based on assessments 4-months and 12-months post-enrollment with logistic regression.|||||
72610986|NCT03699748|144750768|OTHER||Odds Ratio, log|19.55|||||TWO_SIDED||||||||Odds Ratios for Goals of Care Documentation, Advance Directive Documentation, and Physician Order for Life Sustaining Treatment Documentation were estimated based on assessments at 12-months post-enrollment with logistic regression.|||||
72610987|NCT03699748|144750769|OTHER||Effect Estimate|0.65|||||TWO_SIDED||||||||0.65 (0.44-0.98)||Proportional change in total health care costs are expressed as referent to the control group and were modeled using a generalized linear model with gamma link-log function to account for skewed cost data after adjustment for length of follow-up.|||
72610988|NCT03699748|144750770|OTHER||Effect Estimate|0.57|||||TWO_SIDED||||||||0.57 (0.28 - 1.18)||Proportional change in total health care costs are expressed as referent to the control group and were modeled using a generalized linear model with gamma link-log function to account for skewed cost data.|||
72610989|NCT03699748|144750771|OTHER||Odds Ratio (OR)|6.82|||||TWO_SIDED||||||||6.82 (2.46-18.93)||Odds Ratios for palliative care receipt and hospice receipt were estimated based on assessments 4-months and 12-months post-enrollment compared with baseline (time of enrollment) using logistic regression.|||
72610990|NCT03699748|144750772|OTHER||Odds Ratio (OR)|3.62|||||TWO_SIDED||||||||3.62 (1.73-7.60)||Odds Ratios for palliative care receipt and hospice receipt were estimated based on assessments 4-months and 12-months post-enrollment compared with baseline (time of enrollment) using logistic regression.|||
72610991|NCT03699748|144750773|OTHER||Effect Estimate|5.71|||||TWO_SIDED||||||||5.71 (1.56-20.93)||Odds Ratios for any ED Use and any Palliative Care were estimated using logistic regression models. Incidence Rate Ratios (IRR) were estimated using Poisson models. All ratios are expressed as referent to the control group.|||
72610992|NCT03699748|144750774|OTHER||Odds Ratio (OR)|4.33|||||TWO_SIDED||||||||4.33 (0.89-21.08)||Odds Ratios for palliative care receipt and hospice receipt were estimated based on assessments 4-months and 12-months post-enrollment compared with baseline (time of enrollment) using logistic regression.|||
72610993|NCT03699748|144750775|OTHER||Odds Ratio (OR)|2.76|||||TWO_SIDED||||||||2.76 (1.01-7.55)||Odds Ratios for palliative care receipt and hospice receipt were estimated based on assessments at 12-months post-enrollment compared with baseline (time of enrollment) using logistic regression.|||
72610994|NCT03699748|144750776|OTHER||Effect Estimate|5.71|||||TWO_SIDED||||||||5.71 (1.56-20.93)||Odds Ratios for any ED Use and any Hospice Receipt were estimated using logistic regression models. Incidence Rate Ratios (IRR) were estimated using Poisson models. All ratios are expressed as referent to the control group.|||
72610995|NCT02814526|144750782|SUPERIORITY||Mean Difference (Net)|0.078||||0.29|TWO_SIDED||||||Regression, Linear|||||||0.29
72610996|NCT02814526|144750783|SUPERIORITY||Mean Difference (Net)|0.031||||0.74|TWO_SIDED||||||Regression, Linear|||||||0.74
72610997|NCT02814526|144750784|SUPERIORITY||Mean Difference (Net)|-0.009447||||0.8284|TWO_SIDED||||||Regression, Linear|||||||0.8284
72610998|NCT02814526|144750785|SUPERIORITY||Mean Difference (Net)|-0.02024||||0.7086|TWO_SIDED||||||Regression, Linear|||||||0.7086
72610999|NCT02814526|144750786|SUPERIORITY||Mean Difference (Net)|0.29||||0.06|TWO_SIDED||||||Regression, Linear|||||||0.06
72611000|NCT02814526|144750787|SUPERIORITY||Mean Difference (Net)|-0.17||||0.33|TWO_SIDED||||||Regression, Linear|||||||0.33
72611001|NCT02814526|144750788|SUPERIORITY||Mean Difference (Net)|-0.1||||0.49|TWO_SIDED||||||Regression, Linear|||||||0.49
72611002|NCT02814526|144750789|SUPERIORITY||Mean Difference (Net)|-0.02||||0.61|TWO_SIDED||||||Regression, Linear|||||||0.61
72611003|NCT02814526|144750790|SUPERIORITY||Mean Difference (Net)|-0.01||||0.78|TWO_SIDED||||||Regression, Linear|||||||0.78
72611004|NCT02814526|144750791|SUPERIORITY||Mean Difference (Net)|-0.04||||0.31|TWO_SIDED||||||Regression, Linear|||||||0.31
72611005|NCT02814526|144750792|SUPERIORITY||Mean Difference (Net)|-0.0005||||0.817|TWO_SIDED||||||Regression, Linear|||||||0.817
72611006|NCT02814526|144750793|SUPERIORITY||Mean Difference (Net)|0.002||||0.64|TWO_SIDED||||||Regression, Linear|||||||0.64
72611007|NCT02814526|144750794|SUPERIORITY||Mean Difference (Net)|-0.01||||0.97|TWO_SIDED||||||Regression, Linear|||||||0.97
72611008|NCT02814526|144750795|SUPERIORITY||Mean Difference (Net)|-0.17||||0.94|TWO_SIDED||||||Regression, Linear|||||||0.94
72611009|NCT00251758|144750802|SUPERIORITY_OR_OTHER||||||<|1e-05||||||The overall 0.0025 level of significance for the multiple comparisons of each dexlansoprazole MR dose to placebo was controlled using Hochberg's method.|Wilcoxon (Mann-Whitney)|||The comparison between the two treatment groups was made using Wilcoxon rank-sum test.||||<0.00001
72611010|NCT00251758|144750802|SUPERIORITY_OR_OTHER||||||<|1e-05||||||The overall 0.0025 level of significance for the multiple comparisons of each dexlansoprazole MR dose to placebo was controlled using Hochberg's method.|Wilcoxon (Mann-Whitney)|||The comparison between the two treatment groups was made using Wilcoxon rank-sum test.||||<0.00001
72326294|NCT02722408|144175868|OTHER|||||||0.6325||||||Mixed-effects model for repeated measures analysis with percent change in TG as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28 (Met EAS Clinical Diagnosis of HoFH)||||0.6325
72326295|NCT02722408|144175868|OTHER|||||||0.9221||||||Mixed-effects model for repeated measures analysis with percent change in TG as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28 (Met EAS Clinical Diagnosis of HoFH)||||0.9221
72326296|NCT02722408|144175868|OTHER|||||||0.8387||||||Mixed-effects model for repeated measures analysis with percent change in TG as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84 (Met EAS Clinical Diagnosis of HoFH)||||0.8387
72326297|NCT02722408|144175868|OTHER|||||||0.0089||||||Mixed-effects model for repeated measures analysis with percent change in TG as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28 (Not Met EAS Clinical Diagnosis of HoFH)||||0.0089
72326298|NCT02722408|144175868|OTHER|||||||0.0013||||||Mixed-effects model for repeated measures analysis with percent change in TG as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56 (Not Met EAS Clinical Diagnosis of HoFH)||||0.0013
72418385|NCT00428090|144347170|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.957|TWO_SIDED|95.0|-1.6|1.5||Comparison between Placebo and RSG XR 2mg at Week 8 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||1.5|-1.6|0.957
72326299|NCT02722408|144175868|OTHER|||||||0.0019||||||Mixed-effects model for repeated measures analysis with percent change in TG as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84 (Not Met EAS Clinical Diagnosis of HoFH)||||0.0019
72611011|NCT00251758|144750802|SUPERIORITY_OR_OTHER|||||||0.15505||||||Statistical significance was determined at 0.0025 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||The comparison between the two treatment groups was made using Wilcoxon rank-sum test.||||0.15505
72611012|NCT00251758|144750804|SUPERIORITY_OR_OTHER|||||||1e-05||||||The overall 0.0025 level of significance for the multiple comparisons of each dexlansoprazole MR dose to placebo was controlled using Hochberg's method.|Wilcoxon (Mann-Whitney)|||The comparison between the two treatment groups was made using Wilcoxon rank-sum test.||||0.00001
72611013|NCT00251758|144750804|SUPERIORITY_OR_OTHER||||||<|1e-05||||||The overall 0.0025 level of significance for the multiple comparisons of each dexlansoprazole MR dose to placebo was controlled using Hochberg's method.|Wilcoxon (Mann-Whitney)|||The comparison between the two treatment groups was made using Wilcoxon rank-sum test.||||<0.00001
72611014|NCT00251758|144750804|SUPERIORITY_OR_OTHER|||||||0.3874||||||Statistical significance was determined at 0.0025 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||The comparison between the two treatment groups was made using Wilcoxon rank-sum test.||||0.38740
72611015|NCT01387269|144750806|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon rank sum test|||Superiority analysis||||< 0.0001
72611016|NCT01387269|144750807|SUPERIORITY_OR_OTHER|||||||0.1475|||||||Wilcoxon rank sum test|||Superiority analysis||||0.1475
72611017|NCT01387269|144750808|SUPERIORITY_OR_OTHER|||||||0.0004|||||||Mixed Models Analysis|||Superiority analysis||||0.0004
72611018|NCT01387269|144750809|SUPERIORITY_OR_OTHER|||||||0.0544|||||||Mixed Models Analysis|||Superiority analysis||||0.0544
72611019|NCT01387269|144750810|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||Superiority analysis||||< 0.0001
72611020|NCT01981616|144750813|NON_INFERIORITY_OR_EQUIVALENCE|"With 55 evaluable participants in each group, the study would have at least 80% power to exclude the non-inferiority margin of 15% with the lower bound of the 1-sided 95% confidence interval (CI) on the difference in proportions between vedolizumab- and placebo-treated participants, assuming a 90% seroconversion rate (anti-HBs of 10 IU/L) for hepatitis B vaccine.~If the lower bound of this interval was less than -15% (ie, more negative), then the null hypothesis was accepted."|Difference from placebo|-1.8|||||TWO_SIDED|95.0|-12.7|9.1||||||||9.1|-12.7|
72611021|NCT01981616|144750814|NON_INFERIORITY_OR_EQUIVALENCE|The sample size of 55 evaluable subjects in the vedolizumab 750 mg IV group and 55 evaluable participants in the placebo group provided at least 71% power to exclude the non-inferiority margin of 15% with the lower bound of the 1-sided 95% CI on the difference in proportions between vedolizumab- and placebo-treated participants, assuming an 85% seroconversion rate to the oral cholera vaccine (Dukoral).|Difference from placebo|-14.2|||||TWO_SIDED|95.0|-24.6|-3.9||||||||-3.9|-24.6|
72611022|NCT01141608|144750847|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05|||||||Linear mixed effects model|||||||<0.05
72611023|NCT02753881|144750866|OTHER|||||||0.036||||||Two-sided p-values \<0.05 considered statistically significant.|Kruskal-Wallis|||To achieve high probability (80% power) to detect 50% change with 5% significance level, calculated total sample size was 30 participants for dose normalized doxorubicin.||||.036
72611024|NCT02753881|144750866|OTHER|||||||0.002||||||Two-sided p-values \<0.05 considered statistically significant.|Kruskal-Wallis|||To achieve high probability (80% power) to detect 50% change with 5% significance level, calculated total sample size was 30 participants for dose normalized doxorubicinol.||||0.002
72611025|NCT02753881|144750868|OTHER|||||||0.023||||||Two-sided p-values \<0.05 considered statistically significant.|Kruskal-Wallis|||To achieve high probability (80% power) to detect 50% change with 5% significance level, calculated total sample size was 30 participants for time-concentration-curves for doxorubicin.||||0.023
72611026|NCT02753881|144750868|OTHER|||||||0.041||||||Two-sided p-values \<0.05 considered statistically significant.|Kruskal-Wallis|||To achieve high probability (80% power) to detect 50% change with 5% significance level, calculated total sample size was 30 participants for time-concentration-curves for doxorubicinol.||||0.041
72611027|NCT00506675|144750873|SUPERIORITY_OR_OTHER|||||||0.3|TWO_SIDED|95.0|||||ANCOVA|||||||0.30
72611028|NCT00506675|144750874|SUPERIORITY_OR_OTHER|||||||0.3||95.0|||||ANCOVA|||||||0.30
72611029|NCT00506675|144750875|SUPERIORITY_OR_OTHER|||||||0.3|TWO_SIDED|95.0|||||ANCOVA|||||||0.30
72611030|NCT02858908|144750881|OTHER|Analysis of change in efficacy variables from baseline to week 12 were performed using mixed effect model repeated measures (MMRM) with baseline value as a covariate, dose group and visit as fixed effects and a treatment-by-visit interaction. Adjusted least square mean estimates were produced by dose group and study visit and were presented with two-sided 95% confidence intervals and p-values.|Mean Difference (Net)|-0.6696||||0.0484|TWO_SIDED|95.0|-1.334|-0.0051|||Mixed Models Analysis||The mean difference is an adjusted Least Square Mean|Change from baseline to week 12 in the time taken (seconds) to complete 10-metre walk/run test at the preferred speed||-0.0051|-1.3340|0.0484
72611031|NCT02858908|144750881|OTHER|Analysis of change in efficacy variables from baseline to week 12 were performed using mixed effect model repeated measures (MMRM) with baseline value as a covariate, dose group and visit as fixed effects and a treatment-by-visit interaction. Adjusted least square mean estimates were produced by dose group and study visit and were presented with two-sided 95% confidence intervals and p-values.|Mean Difference (Net)|-0.6449||||0.0565|TWO_SIDED|95.0|-1.3094|0.0195|||Mixed Models Analysis||The mean difference is an adjusted Least Square Mean|Change from baseline to week 12 in the time taken (seconds) to complete 10-metre walk/run test at the preferred speed||0.0195|-1.3094|0.0565
72611032|NCT02858908|144750882|OTHER|Analysis of change in efficacy variables from baseline to week 12 were performed using mixed effect model repeated measures (MMRM) with baseline value as a covariate, dose group and visit as fixed effects and a treatment-by-visit interaction. Adjusted least square mean estimates were produced by dose group and study visit and were presented with two-sided 95% confidence intervals and p-values.|Mean Difference (Net)|0.9102||||0.3732|TWO_SIDED|95.0|-1.1526|2.973|||Mixed Models Analysis||The mean difference is an adjusted Least Square Mean|Change from baseline to week 12 in grip strength (kg)||2.9730|-1.1526|0.3732
72611033|NCT02858908|144750882|OTHER|Analysis of change in efficacy variables from baseline to week 12 were performed using mixed effect model repeated measures (MMRM) with baseline value as a covariate, dose group and visit as fixed effects and a treatment-by-visit interaction. Adjusted least square mean estimates were produced by dose group and study visit and were presented with two-sided 95% confidence intervals and p-values.|Mean Difference (Net)|-1.3897||||0.1782|TWO_SIDED|95.0|-3.4525|0.6731|||Mixed Models Analysis||The mean difference is an adjusted Least Square Mean|Change from baseline to week 12 in grip strength (kg)||0.6731|-3.4525|0.1782
72611034|NCT02858908|144750883|OTHER|Analysis of change in efficacy variables from baseline to week 12 were performed using mixed effect model repeated measures (MMRM) with baseline value as a covariate, dose group and visit as fixed effects and a treatment-by-visit interaction. Adjusted least square mean estimates were produced by dose group and study visit and were presented with two-sided 95% confidence intervals and p-values.|Mean Difference (Net)|-0.0213||||0.8886|TWO_SIDED|95.0|-0.3368|0.2941|||Mixed Models Analysis||The mean difference is an adjusted Least Square Mean|Change from baseline to week 12 in FVC (litres)||0.2941|-0.3368|0.8886
72611035|NCT02858908|144750883|OTHER|Analysis of change in efficacy variables from baseline to week 12 were performed using mixed effect model repeated measures (MMRM) with baseline value as a covariate, dose group and visit as fixed effects and a treatment-by-visit interaction. Adjusted least square mean estimates were produced by dose group and study visit and were presented with two-sided 95% confidence intervals and p-values.|Mean Difference (Net)|0.0152||||0.9204|TWO_SIDED|95.0|-0.3003|0.3307|||Mixed Models Analysis||The mean difference is an adjusted Least Square Mean|Change from baseline to week 12 in FVC (litres)||0.3307|-0.3003|0.9204
72611036|NCT02858908|144750884|OTHER|The exact Wilcoxon signed rank test was used to test for a change in the DXA scan total lean muscle mass (g) from baseline to end of treatment|Median Difference (Net)|-42.75||||1|TWO_SIDED|95.0|-1270.0|2178.5|||ANCOVA||Hodges-Lehmann estimates for the median and confidence intervals are presented|Changes from baseline to week 12 in the DXA scan total lean muscle mass (g)||2178.50|-1270.00|1.0000
72611037|NCT02858908|144750884|OTHER|The exact Wilcoxon signed rank test was used to test for a change in the DXA scan total lean muscle mass (g) from baseline to end of treatment|Median Difference (Net)|426.75||||0.3125|TWO_SIDED|95.0|-289.5|1198.5|||ANCOVA||Hodges-Lehmann estimates for the median and confidence intervals are presented|Changes from baseline to week 12 in the DXA scan total lean muscle mass (g)||1198.50|-289.50|0.3125
72611038|NCT02858908|144750886|OTHER|A mixed effect model repeated measure (MMRM) was fitted to the observed values at week12. The model included dose group and visit as fixed effects, and the treatment-by-visit interaction. F-tests from PROC MIXED were based on Kenward-Roger's adjusted degrees of freedom.|Mean Difference (Net)|3.1||||0.003|TWO_SIDED|95.0|2.6|3.7||The p-value is presented for the comparison of adjusted Least Square Means to a score of 4, representing 'No change'|Mixed Models Analysis|||Observed value at week 12 in Clinical Global Impression Global Improvement Scale (CGI-I)||3.7|2.6|0.0030
72611039|NCT02858908|144750886|OTHER|A mixed effect model repeated measure (MMRM) was fitted to the observed values at week12. The model included dose group and visit as fixed effects, and the treatment-by-visit interaction. F-tests from PROC MIXED were based on Kenward-Roger's adjusted degrees of freedom.|Mean Difference (Net)|3.0||||0.0009|TWO_SIDED|95.0|2.4|3.6||The p-value is presented for the comparison of adjusted Least Square Means to a score of 4, representing 'No change'|Mixed Models Analysis|||Observed value at week 12 in Clinical Global Impression Global Improvement Scale (CGI-I)||3.6|2.4|0.0009
72611040|NCT02858908|144750887|OTHER|Analysis of change in efficacy variables from baseline to week 12 were performed using mixed effect model repeated measures (MMRM) with baseline value as a covariate, dose group and visit as fixed effects and a treatment-by-visit interaction. Adjusted least square mean estimates were produced by dose group and study visit and were presented with two-sided 95% confidence intervals and p-values.|Mean Difference (Net)|-0.132||||0.1857|TWO_SIDED|95.0|-0.33|0.066|||Mixed Models Analysis||The mean difference is an adjusted Least Square Mean|Change from baseline to week 12 in the weekly total number of 3 minute bouts of activity per hour wear time||0.066|-0.330|0.1857
72326300|NCT02722408|144175869|OTHER|||||||0.9195||||||Mixed-effects model for repeated measures analysis with change in TG as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28 (Negative LDLr)||||0.9195
72418386|NCT00428090|144347170|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.4||||0.693|TWO_SIDED|95.0|-1.4|2.2||Comparison between Placebo and RSG XR 8 mg at Week 8 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||2.2|-1.4|0.693
72611041|NCT02858908|144750887|OTHER|Analysis of change in efficacy variables from baseline to week 12 were performed using mixed effect model repeated measures (MMRM) with baseline value as a covariate, dose group and visit as fixed effects and a treatment-by-visit interaction. Adjusted least square mean estimates were produced by dose group and study visit and were presented with two-sided 95% confidence intervals and p-values.|Mean Difference (Net)|-0.325||||0.0054|TWO_SIDED|95.0|-0.549|-0.102|||Mixed Models Analysis||The mean difference is an adjusted Least Square Mean|Change from baseline to week 12 in the weekly total number of 3 minute bouts of activity per hour wear time||-0.102|-0.549|0.0054
72611042|NCT02858908|144750890|OTHER|Analysis of change in efficacy variables from baseline to week 12 were performed using mixed effect model repeated measures (MMRM) with baseline value as a covariate, dose group and visit as fixed effects and a treatment-by-visit interaction. Adjusted least square mean estimates were produced by dose group and study visit and were presented with two-sided 95% confidence intervals and p-values.|Mean Difference (Net)|-2.162||||0.0111|TWO_SIDED|95.0|-3.731|-0.593|||Mixed Models Analysis||The mean difference is an adjusted Least Square Mean|Change from baseline to week 12 in the time taken (seconds) to complete the nine hole peg test for the dominant arm||-0.593|-3.731|0.0111
72611043|NCT02858908|144750890|OTHER|Analysis of change in efficacy variables from baseline to week 12 were performed using mixed effect model repeated measures (MMRM) with baseline value as a covariate, dose group and visit as fixed effects and a treatment-by-visit interaction. Adjusted least square mean estimates were produced by dose group and study visit and were presented with two-sided 95% confidence intervals and p-values.|Mean Difference (Net)|-0.955||||0.2088|TWO_SIDED|95.0|-2.525|0.614|||Mixed Models Analysis||The mean difference is an adjusted Least Square Mean|Change from baseline to week 12 in the time taken (seconds) to complete the nine hole peg test for the dominant arm||0.614|-2.525|0.2088
72326301|NCT02722408|144175869|OTHER|||||||0.7497||||||Mixed-effects model for repeated measures analysis with change in TG as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56 (Negative LDLr)||||0.7497
72326302|NCT02722408|144175869|OTHER|||||||0.5056||||||Mixed-effects model for repeated measures analysis with change in TG as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84 (Negative LDLr)||||0.5056
72326303|NCT02722408|144175869|OTHER|||||||0.2468||||||Mixed-effects model for repeated measures analysis with change in TG as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28 (Defective LDLr)||||0.2468
72326304|NCT02722408|144175869|OTHER|||||||0.392||||||Mixed-effects model for repeated measures analysis with change in TG as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56 (Defective LDLr)||||0.3920
72418387|NCT00428090|144347170|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3||||0.798|TWO_SIDED|95.0|-2.2|1.7||Comparison between Placebo and Donepezil 10 mg at Week 8 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||1.7|-2.2|0.798
72611044|NCT02858908|144750891|OTHER|Analysis of change in efficacy variables from baseline to week 12 were performed using mixed effect model repeated measures (MMRM) with baseline value as a covariate, dose group and visit as fixed effects and a treatment-by-visit interaction. Adjusted least square mean estimates were produced by dose group and study visit and were presented with two-sided 95% confidence intervals and p-values.|Mean Difference (Net)|-1.77||||0.0728|TWO_SIDED|95.0|-3.71|0.18|||Mixed Models Analysis||The mean difference is an adjusted Least Square Mean|Change from baseline to week 12 in the subject top three concerns VAS total score (cm)||0.18|-3.71|0.0728
72326305|NCT02722408|144175869|OTHER|||||||0.4456||||||Mixed-effects model for repeated measures analysis with change in TG as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84 (Defective LDLr)||||0.4456
72326306|NCT02722408|144175869|OTHER|||||||0.9203||||||Mixed-effects model for repeated measures analysis with change in TG as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28 (Met EAS Clinical Diagnosis of HoFH)||||0.9203
72326307|NCT02722408|144175869|OTHER|||||||0.9704||||||Mixed-effects model for repeated measures analysis with change in TG as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56 (Met EAS Clinical Diagnosis of HoFH)||||0.9704
72326308|NCT02722408|144175869|OTHER|||||||0.9755||||||Mixed-effects model for repeated measures analysis with change in TG as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84 (Met EAS Clinical Diagnosis of HoFH)||||0.9755
72326309|NCT02722408|144175869|OTHER|||||||0.4213||||||Mixed-effects model for repeated measures analysis with change in TG as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28 (Not Met EAS Clinical Diagnosis of HoFH)||||0.4213
72326310|NCT02722408|144175869|OTHER|||||||0.03||||||Mixed-effects model for repeated measures analysis with change in TG as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56 (Not Met EAS Clinical Diagnosis of HoFH)||||0.0300
72326311|NCT02722408|144175869|OTHER|||||||0.03||||||Mixed-effects model for repeated measures analysis with change in TG as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84 (Not Met EAS Clinical Diagnosis of HoFH)||||0.0300
72611045|NCT02858908|144750891|OTHER|Analysis of change in efficacy variables from baseline to week 12 were performed using mixed effect model repeated measures (MMRM) with baseline value as a covariate, dose group and visit as fixed effects and a treatment-by-visit interaction. Adjusted least square mean estimates were produced by dose group and study visit and were presented with two-sided 95% confidence intervals and p-values.|Mean Difference (Net)|-1.99||||0.0456|TWO_SIDED|95.0|-3.94|-0.04|||Mixed Models Analysis||The mean difference is an adjusted Least Square Mean|Change from baseline to week 12 in the subject top three concerns VAS total score (cm)||-0.04|-3.94|0.0456
72611046|NCT02858908|144750891|OTHER|Analysis of change in efficacy variables from baseline to week 12 were performed using mixed effect model repeated measures (MMRM) with baseline value as a covariate, dose group and visit as fixed effects and a treatment-by-visit interaction. Adjusted least square mean estimates were produced by dose group and study visit and were presented with two-sided 95% confidence intervals and p-values.|Mean Difference (Net)|-2.41||||0.0058|TWO_SIDED|95.0|-4.03|-0.8|||Mixed Models Analysis||The mean difference is an adjusted Least Square Mean|Change from baseline to week 12 in the caregiver top three concerns VAS total score (cm)||-0.80|-4.03|0.0058
72611047|NCT02858908|144750891|OTHER|Analysis of change in efficacy variables from baseline to week 12 were performed using mixed effect model repeated measures (MMRM) with baseline value as a covariate, dose group and visit as fixed effects and a treatment-by-visit interaction. Adjusted least square mean estimates were produced by dose group and study visit and were presented with two-sided 95% confidence intervals and p-values.|Mean Difference (Net)|-1.95||||0.0208|TWO_SIDED|95.0|-3.56|-0.34|||Mixed Models Analysis||The mean difference is an adjusted Least Square Mean|Change from baseline to week 12 in the caregiver top three concerns VAS total score (cm)||-0.34|-3.56|0.0208
72611048|NCT02858908|144750892|OTHER|Analysis of change in efficacy variables from baseline to week 12 were performed using mixed effect model repeated measures (MMRM) with baseline value as a covariate, dose group and visit as fixed effects and a treatment-by-visit interaction. Adjusted least square mean estimates were produced by dose group and study visit and were presented with two-sided 95% confidence intervals and p-values.|Mean Difference (Net)|-0.054||||0.0068|TWO_SIDED|95.0|-0.092|-0.017|||Mixed Models Analysis||The mean difference is an adjusted Least Square Mean|Change from baseline to week 12 in the OSU Autism Rating Scale - DSM-IV (OARS-4) total impairment mean||-0.017|-0.092|0.0068
72611049|NCT02858908|144750892|OTHER|Analysis of change in efficacy variables from baseline to week 12 were performed using mixed effect model repeated measures (MMRM) with baseline value as a covariate, dose group and visit as fixed effects and a treatment-by-visit interaction. Adjusted least square mean estimates were produced by dose group and study visit and were presented with two-sided 95% confidence intervals and p-values.|Mean Difference (Net)|-0.009||||0.609|TWO_SIDED|95.0|-0.047|0.028|||Mixed Models Analysis||The mean difference is an adjusted Least Square Mean|Change from baseline to week 12 in the OSU Autism Rating Scale - DSM-IV (OARS-4) total impairment mean||0.028|-0.047|0.6090
72611050|NCT02858908|144750893|OTHER|A mixed effect model repeated measure (MMRM) was fitted to the observed values at week12 in OSU CGI-I. The model included dose group and visit as fixed effects, and the treatment-by-visit interaction. F-tests from PROC MIXED were based on Kenward-Roger's adjusted degrees of freedom. A compound symmetry covariance matrix was used for the repeated visits within subject.|Mean Difference (Net)|3.4||||0.0011|TWO_SIDED|95.0|3.0|3.7||p-values are presented for the comparison of adjusted Least Square Means to a score of 4, representing 'No change'|Mixed Models Analysis|||Observed value at week 12 in OSU global improvement scale for autism (OSU CGI-I)||3.7|3.0|0.0011
72611051|NCT02858908|144750893|OTHER|A mixed effect model repeated measure (MMRM) was fitted to the observed values at week12 in OSU CGI-I. The model included dose group and visit as fixed effects, and the treatment-by-visit interaction. F-tests from PROC MIXED were based on Kenward-Roger's adjusted degrees of freedom. A compound symmetry covariance matrix was used for the repeated visits within subject.|Mean Difference (Net)|4.0||||1|TWO_SIDED|95.0|3.6|4.4||p-values are presented for the comparison of adjusted Least Square Means to a score of 4, representing 'No change'|Mixed Models Analysis|||Observed value at week 12 in OSU global improvement scale for autism (OSU CGI-I)||4.4|3.6|1.0000
72611052|NCT02858908|144750894|OTHER|Analysis of change in efficacy variables from baseline to week 12 were performed using mixed effect model repeated measures (MMRM) with baseline value as a covariate, dose group and visit as fixed effects and a treatment-by-visit interaction. Adjusted least square mean estimates were produced by dose group and study visit and were presented with two-sided 95% confidence intervals and p-values.|Mean Difference (Net)|-5.91|||<|0.0001|TWO_SIDED|95.0|-8.35|-3.47|||Mixed Models Analysis||The mean difference is an adjusted Least Square Mean|Change from baseline at week 12 in the clinician-completed domain specific causes for concern VAS total score (cm)||-3.47|-8.35|<0.0001
72611053|NCT02858908|144750894|OTHER|Analysis of change in efficacy variables from baseline to week 12 were performed using mixed effect model repeated measures (MMRM) with baseline value as a covariate, dose group and visit as fixed effects and a treatment-by-visit interaction. Adjusted least square mean estimates were produced by dose group and study visit and were presented with two-sided 95% confidence intervals and p-values.|Mean Difference (Net)|-3.27||||0.0116|TWO_SIDED|95.0|-5.71|-0.83|||Mixed Models Analysis||The mean difference is an adjusted Least Square Mean|Change from baseline at week 12 in the clinician-completed domain specific causes for concern VAS total score (cm)||-0.83|-5.71|0.0116
72611054|NCT02858908|144750895|OTHER|An ANCOVA was fitted to the change in the Peabody Picture Vocabulary Test age-based standard score from baseline to end of treatment. The model included the baseline value as a covariate and dose group as a fixed effect.|Mean Difference (Net)|-1.1||||0.6631|TWO_SIDED|95.0|-6.5|4.3|||ANCOVA||The mean difference is an adjusted Least Square Mean|Change from baseline to week 12 in the peabody picture vocabulary test age-based standard score||4.3|-6.5|0.6631
72418388|NCT00428090|144347170|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.958|TWO_SIDED|95.0|-1.7|1.8||Comparison between Placebo and RSG XR 2 mg at Week 16 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||1.8|-1.7|0.958
72418389|NCT00428090|144347170|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.998|TWO_SIDED|95.0|-2.1|2.1||Comparison between Placebo and RSG XR 8 mg at Week 16 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||2.1|-2.1|0.998
72326312|NCT02722408|144175875|OTHER|||||||0.0294||||||Mixed-effects model for repeated measures analysis with percent change in hsCRP as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300mg: Day 28||||0.0294
72326313|NCT02722408|144175875|OTHER|||||||0.3228||||||Mixed-effects model for repeated measures analysis with percent change in hsCRP as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56||||0.3228
72326314|NCT02722408|144175875|OTHER|||||||0.5268||||||Mixed-effects model for repeated measures analysis with percent change in hsCRP as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84||||0.5268
72326315|NCT02722408|144175876|OTHER|||||||0.1099||||||Mixed-effects model for repeated measures analysis with change in hsCRP as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28||||0.1099
72418390|NCT00428090|144347170|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.5||||0.639||95.0|-1.7|2.8||Comparison between Placebo and Donepezil 10 mg at Week 16 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||2.8|-1.7|0.639
72418391|NCT00428090|144347170|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3||||0.797|TWO_SIDED|95.0|-2.1|2.7||Comparison between Placebo and RSG XR 2 mg at Week 24 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||2.7|-2.1|0.797
72418392|NCT00428090|144347170|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.942|TWO_SIDED|95.0|-2.9|2.7||Comparison between Placebo and RSG XR 8 mg at Week 24 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||2.7|-2.9|0.942
72611055|NCT02858908|144750895|OTHER|An ANCOVA was fitted to the change in the Peabody Picture Vocabulary Test age-based standard score from baseline to end of treatment. The model included the baseline value as a covariate and dose group as a fixed effect.|Mean Difference (Net)|-0.1||||0.9546|TWO_SIDED|95.0|-5.5|5.2|||ANCOVA||The mean difference is an adjusted Least Square Mean|Change from baseline to week 12 in the peabody picture vocabulary test age-based standard score||5.2|-5.5|0.9546
72611056|NCT03573297|144750905|SUPERIORITY||Hazard Ratio (HR)|0.83||||0.5745|TWO_SIDED|95.0|0.48|1.43||P-value is based on the log-rank test stratified by modified index episode (manic or depressive) and region (US, non-US).|Log Rank||Hazard ratio (Cariprazine 1.5 or 3.0 mg/day vs. Placebo) is based on Cox proportional hazards regression model, with treatment group as an explanatory variable, stratified by modified index episode (manic or depressive) and region (US, non-US).|||1.43|0.48|0.5745
72611057|NCT03573297|144750905|SUPERIORITY||Hazard Ratio (HR)|0.89||||0.6308|TWO_SIDED|95.0|0.52|1.51||P-value is based on the log-rank test stratified by modified index episode (manic or depressive) and region (US, non-US).|Log Rank||Hazard ratio (Cariprazine 1.5 or 3.0 mg/day vs. Placebo) is based on Cox proportional hazards regression model, with treatment group as an explanatory variable, stratified by modified index episode (manic or depressive) and region (US, non-US).|||1.51|0.52|0.6308
72611058|NCT01499810|144750906|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||threshold for statistical significance p\<0.05|t-test, 2 sided|||Repeated measures analysis||||<0.0001
72611059|NCT01499810|144750908|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||threshold for statistical significance p\<0.05|t-test, 2 sided|||Repeated measures analysis||||<0.0001
72611060|NCT01499810|144750909|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||threshold for statistical significance p\<0.05|t-test, 2 sided|||Repeated measures analysis||||<0.0001
72611061|NCT01499810|144750910|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||threshold for statistical significance p\<0.05|t-test, 2 sided|||Repeated measures analysis||||<0.0001
72611062|NCT01499810|144750911|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||threshold for statistical significance p\<0.05|t-test, 2 sided|||Repeated measures analysis||||<0.0001
72611063|NCT01499810|144750912|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||threshold for statistical significance p\<0.05|t-test, 2 sided|||Repeated measures analysis||||<0.0001
72611064|NCT01499810|144750913|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0001||||||threshold for statistical significance p\<0.05|t-test, 2 sided|||Repeated measures analysis||||0.0001
72611065|NCT01499810|144750914|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||threshold for statistical significance p\<0.05|t-test, 2 sided|||Repeated measures analysis||||<0.0001
72611066|NCT01499810|144750915|SUPERIORITY_OR_OTHER_LEGACY|||||||0.35||||||threshold for statistical significance p\<0.05|t-test, 2 sided|||Repeated measures analysis||||0.35
72611067|NCT01499810|144750916|SUPERIORITY_OR_OTHER_LEGACY|||||||0.12||||||threshold for statistical significance p\<0.05|t-test, 2 sided|||Repeated measures analysis||||0.12
72611068|NCT01499810|144750917|SUPERIORITY_OR_OTHER_LEGACY|||||||7e-05||||||threshold for statistical significance p\<0.05|t-test, 2 sided|||Repeated measures analysis||||0.00007
72611069|NCT01499810|144750918|SUPERIORITY_OR_OTHER_LEGACY|||||||9e-05||||||threshold for statistical significance p\<0.05|t-test, 2 sided|||Repeated measures analysis||||0.00009
72611070|NCT01499810|144750919|SUPERIORITY_OR_OTHER_LEGACY|||||||4e-05||||||threshold for statistical significance p\<0.05|t-test, 2 sided|||Repeated measures analysis||||0.00004
72611071|NCT01499810|144750920|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0001||||||threshold for statistical significance p\<0.05|t-test, 2 sided|||Repeated measures analysis||||0.0001
72611072|NCT01499810|144750921|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0007||||||threshold for statistical significance p\<0.05|t-test, 2 sided|||Repeated measures analysis||||0.0007
72326316|NCT02722408|144175876|OTHER|||||||0.5478||||||Mixed-effects model for repeated measures analysis with change in hsCRP as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56||||0.5478
72326317|NCT02722408|144175876|OTHER|||||||0.8837||||||Mixed-effects model for repeated measures analysis with change in hsCRP as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84||||0.8837
72326318|NCT02722408|144175877|OTHER|||||||0.0587||||||Mixed-effects model for repeated measures analysis with percent change in fibrinogen as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28||||0.0587
72326319|NCT02722408|144175877|OTHER|||||||0.1491||||||Mixed-effects model for repeated measures analysis with percent change in fibrinogen as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56||||0.1491
72326320|NCT02722408|144175877|OTHER|||||||0.2224||||||Mixed-effects model for repeated measures analysis with percent change in fibrinogen as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84||||0.2224
72326321|NCT02722408|144175878|OTHER|||||||0.0959||||||Mixed-effects model for repeated measures analysis with change in fibrinogen as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28||||0.0959
72326322|NCT02722408|144175878|OTHER|||||||0.0923||||||Mixed-effects model for repeated measures analysis with change in fibrinogen as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56||||0.0923
72418393|NCT00428090|144347170|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.9||||0.213|TWO_SIDED|95.0|-4.8|1.1||Comparison between Placebo and Donepezil 10 mg at Week 24 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||1.1|-4.8|0.213
72326323|NCT02722408|144175878|OTHER|||||||0.1592||||||Mixed-effects model for repeated measures analysis with change in fibrinogen as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84||||0.1592
72326324|NCT02722408|144175879|OTHER|||||||0.5856||||||Mixed-effects model for repeated measures analysis with percent change in Lipoprotein(a) as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28||||0.5856
72326325|NCT02722408|144175879|OTHER|||||||0.644||||||Mixed-effects model for repeated measures analysis with percent change in Lipoprotein(a) as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56||||0.6440
72326326|NCT02722408|144175879|OTHER|||||||0.2269||||||Mixed-effects model for repeated measures analysis with percent change in Lipoprotein(a) as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84||||0.2269
72326327|NCT02722408|144175880|OTHER|||||||0.4814||||||Mixed-effects model for repeated measures analysis with change in Lipoprotein(a) as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28||||0.4814
72326328|NCT02722408|144175880|OTHER|||||||0.5011||||||Mixed-effects model for repeated measures analysis with change in Lipoprotein(a) as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56||||0.5011
72326329|NCT02722408|144175880|OTHER|||||||0.4356||||||Mixed-effects model for repeated measures analysis with change in Lipoprotein(a) as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84||||0.4356
72326330|NCT02722408|144175881|OTHER|||||||0.0669||||||Mixed-effects model for repeated measures analysis with percent change in Apolipoprotein B as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28||||0.0669
72326331|NCT02722408|144175881|OTHER|||||||0.0189||||||Mixed-effects model for repeated measures analysis with percent change in Apolipoprotein B as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56||||0.0189
72326332|NCT02722408|144175881|OTHER|||||||0.0316||||||Mixed-effects model for repeated measures analysis with percent change in Apolipoprotein B as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84||||0.0316
72326333|NCT02722408|144175882|OTHER|||||||0.0685||||||Mixed-effects model for repeated measures analysis with change in Apolipoprotein B as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28||||0.0685
72326334|NCT02722408|144175882|OTHER|||||||0.0114||||||Mixed-effects model for repeated measures analysis with change in Apolipoprotein B as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56||||0.0114
72326335|NCT02722408|144175882|OTHER|||||||0.0263||||||Mixed-effects model for repeated measures analysis with change in Apolipoprotein B as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84||||0.0263
72326336|NCT02722408|144175883|OTHER|||||||0.1466||||||Mixed-effects model for repeated measures analysis with percent change in Apolipoprotein A-I as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28||||0.1466
72611073|NCT01499810|144750922|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001||||||threshold for statistical significance p\<0.05|t-test, 2 sided|||Repeated measures analysis||||0.001
72611074|NCT01499810|144750923|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0004||||||threshold for statistical significance p\<0.05|t-test, 2 sided|||Repeated measures analysis||||0.0004
72611075|NCT01499810|144750924|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0002||||||threshold for statistical significance p\<0.05|t-test, 2 sided|||Repeated measures analysis||||0.0002
72611076|NCT01499810|144750925|SUPERIORITY_OR_OTHER_LEGACY|||||||0.57||||||threshold for statistical significance p\<0.05|t-test, 2 sided|||Repeated measures analysis||||0.57
72611077|NCT01499810|144750926|SUPERIORITY_OR_OTHER_LEGACY|||||||0.54||||||threshold for statistical significance p\<0.05|t-test, 2 sided|||Repeated measures analysis||||0.54
72611078|NCT01499810|144750927|SUPERIORITY_OR_OTHER_LEGACY|||||||0.87||||||threshold for statistical significance p\<0.05|t-test, 2 sided|||Repeated measures analysis||||0.87
72611079|NCT01499810|144750928|SUPERIORITY_OR_OTHER_LEGACY|||||||0.77||||||threshold for statistical significance p\<0.05|t-test, 2 sided|||Repeated measures analysis||||0.77
72611080|NCT01499810|144750929|SUPERIORITY_OR_OTHER_LEGACY|||||||0.06||||||threshold for statistical significance p\<0.05|t-test, 2 sided|||Repeated measures analysis||||0.06
72611081|NCT01499810|144750930|SUPERIORITY_OR_OTHER_LEGACY|||||||0.07||||||threshold for statistical significance p\<0.05|t-test, 2 sided|||Repeated measures analysis||||0.07
72611082|NCT01499810|144750931|SUPERIORITY_OR_OTHER_LEGACY|||||||0.32||||||threshold for statistical significance p\<0.05|t-test, 2 sided|||Repeated measures analysis||||0.32
72611083|NCT01499810|144750932|SUPERIORITY_OR_OTHER_LEGACY|||||||0.12||||||threshold for statistical significance p\<0.05|t-test, 2 sided|||Repeated measures analysis||||0.12
72611084|NCT01499810|144750933|SUPERIORITY_OR_OTHER_LEGACY|||||||0.72||||||threshold for statistical significance p\<0.05|t-test, 2 sided|||Repeated measures analysis||||0.72
72611085|NCT01499810|144750934|SUPERIORITY_OR_OTHER_LEGACY|||||||0.37||||||threshold for statistical significance p\<0.05|t-test, 2 sided|||Repeated measures analysis||||0.37
72611086|NCT01499810|144750935|SUPERIORITY_OR_OTHER_LEGACY|||||||0.99||||||threshold for statistical significance p\<0.05|t-test, 2 sided|||Repeated measures analysis||||0.99
72611087|NCT01499810|144750936|SUPERIORITY_OR_OTHER_LEGACY|||||||0.76||||||threshold for statistical significance p\<0.05|t-test, 2 sided|||Repeated measures analysis||||0.76
72611088|NCT01499810|144750937|SUPERIORITY_OR_OTHER_LEGACY|||||||0.08||||||threshold for statistical significance p\<0.05|t-test, 2 sided|||Repeated measures analysis||||0.08
72611089|NCT01499810|144750938|SUPERIORITY_OR_OTHER_LEGACY|||||||0.35||||||threshold for statistical significance p\<0.05|t-test, 2 sided|||Repeated measures analysis||||0.35
72611090|NCT01499810|144750939|SUPERIORITY_OR_OTHER_LEGACY|||||||0.22||||||threshold for statistical significance p\<0.05|t-test, 2 sided|||Repeated measures analysis||||0.22
72611091|NCT01499810|144750940|SUPERIORITY_OR_OTHER_LEGACY|||||||0.29||||||threshold for statistical significance p\<0.05|t-test, 2 sided|||Repeated measures analysis||||0.29
72611092|NCT01499810|144750941|SUPERIORITY_OR_OTHER_LEGACY|||||||0.89||||||threshold for statistical significance p\<0.05|t-test, 2 sided|||Repeated measures analysis||||0.89
72326337|NCT02722408|144175883|OTHER|||||||0.3598||||||Mixed-effects model for repeated measures analysis with percent change in Apolipoprotein A-I as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56||||0.3598
72611093|NCT01499810|144750942|SUPERIORITY_OR_OTHER_LEGACY|||||||0.65||||||threshold for statistical significance p\<0.05|t-test, 2 sided|||Repeated measures analysis||||0.65
72611094|NCT01499810|144750943|SUPERIORITY_OR_OTHER_LEGACY|||||||0.76||||||threshold for statistical significance p\<0.05|t-test, 2 sided|||Repeated measures analysis||||0.76
72611095|NCT01499810|144750944|SUPERIORITY_OR_OTHER_LEGACY|||||||0.35||||||Repeated measures analysis|t-test, 2 sided|||Repeated measures analysis||||0.35
72611096|NCT01499810|144750945|SUPERIORITY_OR_OTHER_LEGACY|||||||0.92||||||threshold for statistical significance p\<0.05|t-test, 2 sided|||Repeated measures analysis||||0.92
72611097|NCT01499810|144750946|SUPERIORITY_OR_OTHER_LEGACY|||||||0.32||||||threshold for statistical significance p\<0.05|t-test, 2 sided|||Repeated measures analysis||||0.32
72611098|NCT01499810|144750947|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4||||||threshold for statistical significance p\<0.05|t-test, 2 sided|||Repeated measures analysis||||0.40
72611099|NCT01499810|144750948|SUPERIORITY_OR_OTHER_LEGACY|||||||0.17||||||threshold for statistical significance p\<0.05|t-test, 2 sided|||Repeated measures analysis||||0.17
72611100|NCT01499810|144750949|SUPERIORITY_OR_OTHER_LEGACY|||||||0.014||||||threshold for statistical significance p\<0.05|t-test, 2 sided|||Repeated measures analysis||||0.014
72611101|NCT02273167|144750962|NON_INFERIORITY_OR_EQUIVALENCE|The confidence limits (CL) were adjusted for multiple comparisons (two alternative primary endpoints): To be declared non-inferior, the primary endpoint must show a difference in success rates of no greater than 10% in favour of MOVIPREP using lower 1-sided 97.5% CL. Calculated using exact Clopper-Pearson CLs. To accommodate the comparison of 2 NER1006 regimens a hierarchical testing approach was used whereby NER1006 2-Day was assessed first and, if successful, then NER1006 1-Day was evaluated.|Difference in success rate|4.5||||0.055|ONE_SIDED|97.5|-4.0|||The p-value was adjusted for multiple comparisons (two alternative primary endpoints): To be declared superior, primary endpoint must demonstrate non-inferiority with 1-sided p-value \<0.025, the threshold for statistical significance.|Fisher Exact|||Hypothesis was to demonstrate non-inferiority (NI) of NER1006 2-Day to MOVIPREP (10% margin). Success rate was no. of patients with successful overall bowel cleansing as proportion of no. of patients in each group. Treatment effect was NER1006 2-Day success rate - MOVIPREP success rate. Hochberg procedure used to control Type I error since there were 2 alternative primary endpoints. An alpha level of 1.25% 1-sided was used. A closed testing procedure used to evaluate superiority if NI was met.|||-4.00|0.055
72418394|NCT00428090|144347171|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||0.919|TWO_SIDED|95.0|-2.1|2.3||Comparison between Placebo and RSG XR 2 mg at Week 8 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||2.3|-2.1|0.919
72418395|NCT00428090|144347171|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.5||||0.649|TWO_SIDED|95.0|-1.5|2.4||Comparison between Placebo and RSG XR 8 mg at Week 8 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||2.4|-1.5|0.649
72418396|NCT00428090|144347171|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.3||||0.279|TWO_SIDED|95.0|-1.1|3.6||Comparison between Placebo and Donepezil 10 mg at Week 8 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||3.6|-1.1|0.279
72418397|NCT00428090|144347171|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.9||||0.498|TWO_SIDED|95.0|-1.8|3.6||Comparison between Placebo and RSG XR 2 mg at Week 16 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||3.6|-1.8|0.498
72418398|NCT00428090|144347171|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.9||||0.489|TWO_SIDED|95.0|-1.7|3.6||Comparison between Placebo and RSG XR 8 mg in at Week 16 Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||3.6|-1.7|0.489
72611102|NCT02273167|144750962|NON_INFERIORITY_OR_EQUIVALENCE|The CLs were adjusted for multiple comparisons (2 alternative primary endpoints): To be declared non-inferior, the primary endpoint must show a difference in success rates of no greater than 10% in favour of MOVIPREP using lower 1-sided 97.5% CLs. Calculated using exact Clopper-Pearson confidences limits. To accommodate the comparison of two NER1006 regimens a hierarchical testing approach will be used whereby NER1006 2-Day was assessed first and, if successful, then NER1006 1-Day was evaluated.|Difference in success rate|1.59||||0.328|ONE_SIDED|97.5|-6.91|||The p-value was adjusted for multiple comparisons (two alternative primary endpoints): To be declared superior, primary endpoint must demonstrate non-inferiority with 1-sided p-value \<0.025, the threshold for statistical significance.|Fisher Exact|||The hypothesis was to demonstrate NI of NER1006 1-Day to MOVIPREP (10% margin). Success rate was number of patients with successful overall bowel cleansing as proportion of number of patients in each group. Treatment effect was NER1006 1-Day success rate - MOVIPREP success rate. A Hochberg procedure was used to control Type I error since there were two alternative primary endpoints. An alpha level of 1.25% 1-sided was used. A closed testing procedure used to evaluate superiority if NI was met.|||-6.91|0.328
72418399|NCT00428090|144347171|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.7||||0.024|TWO_SIDED|95.0|0.5|7.0||Comparison between Placebo and Donepezil 10 mg at Week 16 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||7.0|0.5|0.024
72418400|NCT00428090|144347171|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.3||||0.385|TWO_SIDED|95.0|-1.6|4.2||Comparison between Placebo and RSG XR 2 mg at Week 24 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||4.2|-1.6|0.385
72418401|NCT00428090|144347171|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.944|TWO_SIDED|95.0|-3.0|2.8||Comparison between Placebo and RSG XR 8 mg at Week 24 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||2.8|-3.0|0.944
72418402|NCT00428090|144347171|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.6||||0.078|TWO_SIDED|95.0|-0.4|7.5||Comparison between Placebo and Donepezil 10 mg at Week 24 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||7.5|-0.4|0.078
72418403|NCT00428090|144347172|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2||||0.635|TWO_SIDED|95.0|-0.8|0.5||Comparison between Placebo and RSG XR 2 mg at Week 8 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||0.5|-0.8|0.635
72326338|NCT02722408|144175883|OTHER|||||||0.0685||||||Mixed-effects model for repeated measures analysis with percent change in Apolipoprotein A-I as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84||||0.0685
72418404|NCT00428090|144347172|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.4||||0.194|TWO_SIDED|95.0|-0.2|1.1||Comparison between Placebo and RSG XR 8 mg at Week 8 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||1.1|-0.2|0.194
72326339|NCT02722408|144175884|OTHER|||||||0.166||||||Mixed-effects model for repeated measures analysis with change in Apolipoprotein A-I as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28||||0.1660
72326340|NCT02722408|144175884|OTHER|||||||0.3423||||||Mixed-effects model for repeated measures analysis with change in Apolipoprotein A-I as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56||||0.3423
72326341|NCT02722408|144175884|OTHER|||||||0.0313||||||Mixed-effects model for repeated measures analysis with change in Apolipoprotein A-I as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84||||0.0313
72326342|NCT02722408|144175885|OTHER|||||||0.7196||||||Mixed-effects model for repeated measures analysis with percent change in Apolipoprotein A-II as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28||||0.7196
72418405|NCT00428090|144347172|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4||||0.325|TWO_SIDED|95.0|-1.3|0.4||Comparison between Placebo and Donepezil 10 mg at Week 8 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||0.4|-1.3|0.325
72326343|NCT02722408|144175885|OTHER|||||||0.4343||||||Mixed-effects model for repeated measures analysis with percent change in Apolipoprotein A-II as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56||||0.4343
72326344|NCT02722408|144175885|OTHER|||||||0.7241||||||Mixed-effects model for repeated measures analysis with percent change in Apolipoprotein A-II as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84||||0.7241
72326345|NCT02722408|144175886|OTHER|||||||0.7952||||||Mixed-effects model for repeated measures analysis with change in Apolipoprotein A-II as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28||||0.7952
72326346|NCT02722408|144175886|OTHER|||||||0.4931||||||Mixed-effects model for repeated measures analysis with change in Apolipoprotein A-II as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56||||0.4931
72326347|NCT02722408|144175886|OTHER|||||||0.8622||||||Mixed-effects model for repeated measures analysis with change in Apolipoprotein A-II as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84||||0.8622
72611103|NCT02273167|144750963|NON_INFERIORITY_OR_EQUIVALENCE|Confidence limits (CL) were adjusted for multiple comparisons (2 alternative primary endpoints): To be declared non-inferior the primary endpoint must show a difference in success rates of no greater than 10% in favour of MOVIPREP using lower 1-sided 97.5% CLs. Calculated using exact Clopper-Pearson CLs. To accommodate the comparison of two NER1006 regimens a hierarchical testing approach will be used whereby NER1006 2-Day was assessed first and, if successful, then NER1006 1-Day was evaluated.|Difference in excellent plus good rate|16.56|||<|0.001|ONE_SIDED|97.5|8.11|||The p-value was adjusted for multiple comparisons (two alternative primary endpoints): To be declared superior, primary endpoint must demonstrate non-inferiority with 1-sided p-value \<0.025, the threshold for statistical significance.|Fisher Exact|||Hypothesis was to demonstrate NI of NER1006 2-Day to MOVIPREP (10% margin). Success rate was no. of patients with highly effective cleansing of the colon ascendens as proportion of no. of patients in each group. Treatment effect was NER1006 2-Day success rate - MOVIPREP success rate. Hochberg procedure was used to control Type I error since there were 2 alternative primary endpoints. An alpha level of 1.25% 1-sided was used. A closed testing procedure used to evaluate superiority if NI was met.|||8.11|<0.001
72418406|NCT00428090|144347172|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.6||||0.109|TWO_SIDED|95.0|-0.1|1.2||Comparison between Placebo and RSG XR 2 mg at Week 16 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||1.2|-0.1|0.109
72611104|NCT02273167|144750963|NON_INFERIORITY_OR_EQUIVALENCE|The confidence limits (CLs) were adjusted for multiple comparisons (2 alternative primary endpoints): To be declared non-inferior the primary endpoint must show a difference in success rates of no greater than 10% in favour of MOVIPREP using lower 1-sided 97.5% CLs. Calculated using exact Clopper-Pearson CLs. To accommodate the comparison of 2 NER1006 regimens a hierarchical testing approach was used whereby NER1006 2-Day was assessed first and, if successful, then NER1006 1-Day was evaluated.|Difference in excellent plus good rate|18.74|||<|0.001|ONE_SIDED|97.5|10.32|||The p-value was adjusted for multiple comparisons (2 alternative primary endpoints): To be declared superior, primary endpoint must demonstrate non-inferiority with 1-sided p-value \<0.025, the threshold for statistical significance.|Fisher Exact|||Hypothesis was to demonstrate NI of NER1006 1-Day to MOVIPREP (10% margin). Success rate was no. of patients with highly effective cleansing of the colon ascendens as proportion of no. of patients in each group. Treatment effect was NER1006 1-Day success rate - MOVIPREP success rate. Hochberg procedure was used to control Type I error since there were 2 alternative primary endpoints. An alpha level of 1.25% 1-sided was used. A closed testing procedure used to evaluate superiority if NI was met.|||10.32|<0.001
72611105|NCT02273167|144750964|NON_INFERIORITY_OR_EQUIVALENCE|To be declared non-inferior, the key secondary endpoint must show a difference in rates of no greater than 10% in favor of MOVIPREP using lower 1-sided 97.5% confidence limits. Calculated using exact Clopper-Pearson confidence limits.|Difference in ADR|3.55||||0.106|TWO_SIDED|95.0|-4.8|12.0||To be declared superior, the key secondary endpoint must demonstrate non-inferiority and show a significant advantage for NER1006 2-Day relative to MOVIPREP with 1-sided p-value \<0.025, the threshold for statistical significance.|Fisher Exact|||If at least one of the alternative primary endpoints was met, then key secondary endpoints for the same colon region as met by the primary endpoint were evaluated hierarchically in a pre-specified order. The difference in ADR was calculated as NER1006 2-Day rate - MOVIPREP rate using 1-sided 97.5% confidence limits. Formal testing was to proceed in the hierarchy if preceding key secondary endpoint met non-inferiority. This procedure ensured overall Type I error control at 2.5% 1-sided.||12.00|-4.80|0.106
72611106|NCT02273167|144750964|NON_INFERIORITY_OR_EQUIVALENCE|To be declared non-inferior, the key secondary endpoint must show a difference in rates of no greater than 10% in favor of MOVIPREP using lower 1-sided 97.5% confidence limits. Calculated using exact Clopper-Pearson confidence limits.|Difference in ADR|3.55||||0.106|TWO_SIDED|95.0|-4.8|12.0||To be declared superior, the key secondary endpoint must demonstrate non-inferiority and show a significant advantage for NER1006 1-Day relative to MOVIPREP with 1-sided p-value \<0.025, the threshold for statistical significance.|Fisher Exact|||If at least one of the alternative primary endpoints was met, then key secondary endpoints for the same colon region as met by the primary endpoint were evaluated hierarchically in a pre-specified order. The difference in ADR was calculated as NER1006 1-Day rate - MOVIPREP rate using 1-sided 97.5% confidence limits. Formal testing was to proceed in the hierarchy if preceding key secondary endpoint met non-inferiority. This procedure ensured overall Type I error control at 2.5% 1-sided.||12.00|-4.80|0.106
72611107|NCT02273167|144750965|NON_INFERIORITY_OR_EQUIVALENCE|To be declared non-inferior, the key secondary endpoint must show a difference in rates of no greater than 10% in favor of MOVIPREP using lower 1-sided 97.5% confidence limits. Calculated using exact Clopper-Pearson confidence limits.|Difference in ADR|-0.29||||0.569|TWO_SIDED|95.0|-8.74|8.02||To be declared superior, the key secondary endpoint must demonstrate non-inferiority and show a significant advantage for NER1006 2-Day relative to MOVIPREP with 1-sided p-value \<0.025, the threshold for statistical significance.|Fisher Exact|||If at least one of the alternative primary endpoints was met, then key secondary endpoints for the same colon region as met by the primary endpoint were evaluated hierarchically in a pre-specified order. The difference in ADR was calculated as NER1006 2-Day rate - MOVIPREP rate using 1-sided 97.5% confidence limits. Formal testing was to proceed in the hierarchy if preceding key secondary endpoint met non-inferiority. This procedure ensured overall Type I error control at 2.5% 1-sided.||8.02|-8.74|0.569
72611108|NCT02273167|144750965|NON_INFERIORITY_OR_EQUIVALENCE|To be declared non-inferior, the key secondary endpoint must show a difference in rates of no greater than 10% in favor of MOVIPREP using lower 1-sided 97.5% confidence limits. Calculated using exact Clopper-Pearson confidence limits.|Difference in ADR|0.8||||0.455|TWO_SIDED|95.0|-7.65|9.11||To be declared superior, the key secondary endpoint must demonstrate non-inferiority and show a significant advantage for NER1006 1-Day relative to MOVIPREP with 1-sided p-value \<0.025, the threshold for statistical significance.|Fisher Exact|||If at least one of the alternative primary endpoints was met, then key secondary endpoints for the same colon region as met by the primary endpoint were evaluated hierarchically in a pre-specified order. The difference in ADR was calculated as NER1006 1-Day rate - MOVIPREP rate using 1-sided 97.5% confidence limits. Formal testing was to proceed in the hierarchy if preceding key secondary endpoint met non-inferiority. This procedure ensured overall Type I error control at 2.5% 1-sided.||9.11|-7.65|0.455
72418407|NCT00428090|144347172|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.7||||0.032|TWO_SIDED|95.0|0.1|1.4||Comparison between Placebo and RSG XR 8 mg at Week 16 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||1.4|0.1|0.032
72611109|NCT02273167|144750966|NON_INFERIORITY_OR_EQUIVALENCE|To accommodate the comparison of two NER1006 regimens, a hierarchical testing approach was used whereby NER1006 2-Day was assessed first and, if successful, then NER1006 1-Day was evaluated. Difference in Polyp Detection Rate in the colon ascendens was calculated as NER1006 2-Day rate - MOVIPREP rate (10% margin) determined using exact Clopper-Pearson confidence limits.|Difference in PDR|7.1||||0.024|TWO_SIDED|95.0|-1.41|15.47|||Fisher Exact|||If at least one of the primary endpoints were met, then key secondary endpoints were evaluated hierarchically in a pre-specified order. Non-inferiority was concluded if the 1-sided 97.5% confidence limit difference in proportion of events between 2 groups excluded a 10% or greater difference was in favor of MOVIPREP. Formal testing was to proceed in the hierarchy if preceding key secondary endpoint had at least met non-inferiority.||15.47|-1.41|0.024
72611110|NCT02273167|144750966|NON_INFERIORITY_OR_EQUIVALENCE|To accommodate the comparison of two NER1006 regimens, a hierarchical testing approach was used whereby NER1006 2-Day was assessed first and, if successful, then NER1006 1-Day was evaluated. Difference in Polyp Detection Rate in the colon ascendens was calculated as NER1006 rate - MOVIPREP rate (10% margin) determined using exact Clopper-Pearson confidence limits. Non-inferiority of NER1006 1-Day to MOVIPREP was proven.|Difference in PDR|2.37||||0.268|TWO_SIDED|95.0|-6.12|10.82||Superiority of NER1006 1-Day to MOVIPREP not demonstrated statistically.|Fisher Exact|||If at least one of the primary endpoints were met, then key secondary endpoints were evaluated hierarchically in a pre-specified order. Non-inferiority was concluded if the 1-sided 97.5% confidence limit difference in proportion of events between 2 groups excluded a 10% or greater difference was in favor of MOVIPREP. Formal testing was to proceed in the hierarchy if preceding key secondary endpoint had at least met non-inferiority.||10.82|-6.12|0.268
72326348|NCT02722408|144175887|OTHER|||||||0.9823||||||Mixed-effects model for repeated measures analysis with percent change in Apolipoprotein C-II as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28||||0.9823
72326349|NCT02722408|144175887|OTHER|||||||0.9129||||||Mixed-effects model for repeated measures analysis with percent change in Apolipoprotein C-II as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56||||0.9129
72326350|NCT02722408|144175887|OTHER|||||||0.7762||||||Mixed-effects model for repeated measures analysis with percent change in Apolipoprotein C-II as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 84||||0.7762
72418408|NCT00428090|144347172|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7||||0.189|TWO_SIDED|95.0|-1.7|0.3||Comparison between Placebo and Donepezil 10 mg at Week 16 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||0.3|-1.7|0.189
72326351|NCT02722408|144175888|OTHER|||||||0.2683||||||Mixed-effects model for repeated measures analysis with change in Apolipoprotein C-II as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28||||0.2683
72326352|NCT02722408|144175888|OTHER|||||||0.088||||||Mixed-effects model for repeated measures analysis with change in Apolipoprotein C-II as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56||||0.0880
72418409|NCT00428090|144347172|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4||||0.288|TWO_SIDED|95.0|-1.1|0.3||Comparison between Placebo and RSG XR 2 mg at Week 24 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||0.3|-1.1|0.288
72611111|NCT02273167|144750967|NON_INFERIORITY_OR_EQUIVALENCE|To accommodate the comparison of two NER1006 regimens, a hierarchical testing approach was used whereby NER1006 2-Day was assessed first and, if successful, then NER1006 1-Day was evaluated. Difference in Polyp Detection Rate in the overall colon was calculated as NER1006 rate - MOVIPREP rate (10% margin) determined using exact Clopper-Pearson confidence intervals.|Difference in PDR|-0.49||||0.579|TWO_SIDED|95.0|-8.85|8.0|||Fisher Exact|||If at least one of the primary endpoints were met, then key secondary endpoints were evaluated hierarchically in a pre-specified order. Non-inferiority was concluded if the 1-sided 97.5% confidence limit difference in proportion of events between 2 groups excluded a 10% or greater difference was in favor of MOVIPREP. Formal testing was to proceed in the hierarchy if preceding key secondary endpoint had at least met non-inferiority.||8.00|-8.85|0.579
72611112|NCT02273167|144750967|NON_INFERIORITY_OR_EQUIVALENCE|To accommodate the comparison of two NER1006 regimens, a hierarchical testing approach was used whereby NER1006 2-Day was assessed first and, if successful, then NER1006 1-Day was evaluated. Difference in Polyp Detection Rate in the overall colon was calculated as NER1006 1-Day rate - MOVIPREP rate (10% margin) determined using exact Clopper-Pearson confidence limits.|Difference in PDR|0.61||||0.478|TWO_SIDED|95.0|-7.78|9.09|||Fisher Exact|||If at least one of the primary endpoints were met, then key secondary endpoints were evaluated hierarchically in a pre-specified order. Non-inferiority was concluded if the 1-sided 97.5% confidence limit difference in proportion of events between 2 groups excluded a 10% or greater difference was in favor of MOVIPREP. Formal testing was to proceed in the hierarchy if preceding key secondary endpoint had at least met non-inferiority.||9.09|-7.78|0.478
72611113|NCT00498550|144751012|SUPERIORITY||difference in treatment means|-4.54|STANDARD_ERROR_OF_MEAN|2.57||0.088|TWO_SIDED||||||Mixed Models Analysis||We report the estimated coefficient for difference in treatment means in a mixed model and its standard error.|||||.088
72611114|NCT00849056|144751024|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.75|||<|0.0001|TWO_SIDED|95.0|-0.95|-0.56|||ANCOVA|||||-0.56|-0.95|<0.0001
72611115|NCT01721798|144751061|NON_INFERIORITY|Primary Outcome Analysis: Proportion of women with detectable genital viral load across 24 months|Odds Ratio (OR)|0.87||||0.66|TWO_SIDED|95.0|0.47|1.62|||GEE|||C-IUD is comparator group.||1.62|0.47|0.66
72611116|NCT01721798|144751062|NON_INFERIORITY|Secondary Outcome Analysis of Proportion with Detectable plasma viral load users at 24 months|Odds Ratio (OR)|0.83||||0.64|TWO_SIDED|95.0|0.37|1.86|||GEE|Adjusted as-treated analysis||C-IUD is comparator group.||1.86|0.37|0.64
72611117|NCT01721798|144751064|NON_INFERIORITY|Secondary Outcome Analysis of Allocated IUC continuation at 24 months|Hazard Ratio (HR)|8.61|||<|0.001|TWO_SIDED|95.0|3.03|24.4|||Regression, Cox|||C-IUD is comparator group.||24.4|3.03|<0.001
72611118|NCT02081807|144751069|OTHER||Hazard Ratio (HR)|1.0|||||TWO_SIDED|95.0|0.57|1.76|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).||Optum Clinformatic-Dabigatran vs. Warfarin (as reference group).||1.76|0.57|
72611119|NCT02081807|144751069|OTHER||Hazard Ratio (HR)|0.69|||||TWO_SIDED|95.0|0.52|0.94|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).||MarketScan-Dabigatran vs. Warfarin (as reference group).||0.94|0.52|
72611120|NCT02081807|144751069|OTHER||Hazard Ratio (HR)|0.75|||||TWO_SIDED|95.0|0.58|0.98|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis.||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic-Dabigatran vs. Warfarin (as reference group).||0.98|0.58|
72611121|NCT02081807|144751069|OTHER||Hazard Ratio (HR)|0.84|||||TWO_SIDED|95.0|0.53|1.35|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).||Optum Clinformatic- Rivaroxaban vs. Warfarin (as reference group).||1.35|0.53|
72611122|NCT02081807|144751069|OTHER||Hazard Ratio (HR)|0.75|||||TWO_SIDED|95.0|0.57|0.98|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).||MarketScan-Rivaroxaban vs. Warfarin (as reference group).||0.98|0.57|
72611123|NCT02081807|144751069|OTHER||Hazard Ratio (HR)|0.77|||||TWO_SIDED|95.0|0.61|0.98|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis.||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic- Rivaroxaban vs. Warfarin (as reference group).||0.98|0.61|
72611124|NCT02081807|144751069|OTHER||Hazard Ratio (HR)|0.9|||||TWO_SIDED|95.0|0.53|1.51|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).||Optum Clinformatic- Apixaban vs. Warfarin (as reference group).||1.51|0.53|
72611125|NCT02081807|144751069|OTHER||Hazard Ratio (HR)|0.58|||||TWO_SIDED|95.0|0.38|0.89|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).||MarketScan-Apixaban vs. Warfarin (as reference group).||0.89|0.38|
72611126|NCT02081807|144751069|OTHER||Hazard Ratio (HR)|0.69|||||TWO_SIDED|95.0|0.5|0.96|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis.||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic- Apixaban vs. Warfarin (as reference group).||0.96|0.50|
72611127|NCT02081807|144751070|OTHER||Hazard Ratio (HR)|0.51|||||TWO_SIDED|95.0|0.38|0.69|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).||Optum Clinformatic-Dabigatran vs. Warfarin (as reference group).||0.69|0.38|
72611128|NCT02081807|144751070|OTHER||Hazard Ratio (HR)|0.76|||||TWO_SIDED|95.0|0.68|0.86|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).||MarketScan-Dabigatran vs. Warfarin (as reference group).||0.86|0.68|
72611129|NCT02081807|144751070|OTHER||Hazard Ratio (HR)|0.72|||||TWO_SIDED|95.0|0.65|0.8|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis.||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic-Dabigatran vs. Warfarin (as reference group).||0.80|0.65|
72611130|NCT02081807|144751070|OTHER||Hazard Ratio (HR)|1.06|||||TWO_SIDED|95.0|0.88|1.26|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).||Optum Clinformatic- Rivaroxaban vs. Warfarin (as reference group).||1.26|0.88|
72611131|NCT02081807|144751070|OTHER||Hazard Ratio (HR)|1.01|||||TWO_SIDED|95.0|0.92|1.12|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).||MarketScan-Rivaroxaban vs. Warfarin (as reference group).||1.12|0.92|
72611132|NCT02081807|144751070|OTHER||Hazard Ratio (HR)|1.02|||||TWO_SIDED|95.0|0.94|1.12|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis.||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic- Rivaroxaban vs. Warfarin (as reference group).||1.12|0.94|
72611133|NCT02081807|144751070|OTHER||Hazard Ratio (HR)|0.51|||||TWO_SIDED|95.0|0.39|0.66|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).||Optum Clinformatic- Apixaban vs. Warfarin (as reference group).||0.66|0.39|
72611134|NCT02081807|144751070|OTHER||Hazard Ratio (HR)|0.58|||||TWO_SIDED|95.0|0.49|0.68|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).||MarketScan-Apixaban vs. Warfarin (as reference group).||0.68|0.49|
72611135|NCT02081807|144751070|OTHER||Hazard Ratio (HR)|0.56|||||TWO_SIDED|95.0|0.49|0.64|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis.||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic- Apixaban vs. Warfarin (as reference group).||0.64|0.49|
72611136|NCT02081807|144751071|OTHER||Hazard Ratio (HR)|0.87|||||TWO_SIDED|95.0|0.69|1.11|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis.||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic-Dabigatran vs. Warfarin (as reference group).||1.11|0.69|
72611137|NCT02081807|144751071|OTHER||Hazard Ratio (HR)|0.82|||||TWO_SIDED|95.0|0.66|1.02|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis.||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic- Rivaroxaban vs. Warfarin (as reference group).||1.02|0.66|
72611138|NCT02081807|144751071|OTHER||Hazard Ratio (HR)|0.64|||||TWO_SIDED|95.0|0.47|0.88|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis.||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic- Apixaban vs. Warfarin (as reference group).||0.88|0.47|
72611139|NCT02081807|144751072|OTHER||Hazard Ratio (HR)|1.85|||||TWO_SIDED|95.0|1.03|3.3|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis.||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic-Dabigatran vs. Warfarin (as reference group).||3.30|1.03|
72611140|NCT02081807|144751072|OTHER||Hazard Ratio (HR)|1.05|||||TWO_SIDED|95.0|0.65|1.71|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis.||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic- Rivaroxaban vs. Warfarin (as reference group).||1.71|0.65|
72611141|NCT02081807|144751072|OTHER||Hazard Ratio (HR)|0.31|||||TWO_SIDED|95.0|0.1|0.96|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis.||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic- Apixaban vs. Warfarin (as reference group).||0.96|0.10|
72611142|NCT02081807|144751073|OTHER||Hazard Ratio (HR)|0.84|||||TWO_SIDED|95.0|0.63|1.12|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis.||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic-Dabigatran vs. Warfarin (as reference group).||1.12|0.63|
72611143|NCT02081807|144751073|OTHER||Hazard Ratio (HR)|0.74|||||TWO_SIDED|95.0|0.57|0.96|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis.||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic- Rivaroxaban vs. Warfarin (as reference group).||0.96|0.57|
72611144|NCT02081807|144751073|OTHER||Hazard Ratio (HR)|0.65|||||TWO_SIDED|95.0|0.45|0.94|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis.||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic- Apixaban vs. Warfarin (as reference group).||0.94|0.45|
72611145|NCT02081807|144751074|OTHER||Hazard Ratio (HR)|0.37|||||TWO_SIDED|95.0|0.18|0.78|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis.||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic-Dabigatran vs. Warfarin (as reference group).||0.78|0.18|
72611146|NCT02081807|144751074|OTHER||Hazard Ratio (HR)|1.0|||||TWO_SIDED|95.0|0.58|1.72|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis.||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic- Rivaroxaban vs. Warfarin (as reference group).||1.72|0.58|
72611147|NCT02081807|144751074|OTHER||Hazard Ratio (HR)|0.85|||||TWO_SIDED|95.0|0.38|1.87|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis.||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic- Apixaban vs. Warfarin (as reference group).||1.87|0.38|
72611148|NCT02081807|144751076|OTHER||Hazard Ratio (HR)|0.39|||||TWO_SIDED|95.0|0.25|0.59|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis.||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic-Dabigatran vs. Warfarin (as reference group).||0.59|0.25|
72611149|NCT02081807|144751076|OTHER||Hazard Ratio (HR)|0.7|||||TWO_SIDED|95.0|0.51|0.95|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis.||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic- Rivaroxaban vs. Warfarin (as reference group).||0.95|0.51|
72611150|NCT02081807|144751076|OTHER||Hazard Ratio (HR)|0.67|||||TWO_SIDED|95.0|0.43|1.03|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis.||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic- Apixaban vs. Warfarin (as reference group).||1.03|0.43|
72611151|NCT02081807|144751077|OTHER||Hazard Ratio (HR)|0.75|||||TWO_SIDED|95.0|0.67|0.84|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis.||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic-Dabigatran vs. Warfarin (as reference group).||0.84|0.67|
72611152|NCT02081807|144751077|OTHER||Hazard Ratio (HR)|1.06|||||TWO_SIDED|95.0|0.97|1.16|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis.||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic- Rivaroxaban vs. Warfarin (as reference group).||1.16|0.97|
72611153|NCT02081807|144751077|OTHER||Hazard Ratio (HR)|0.54|||||TWO_SIDED|95.0|0.47|0.63|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis.||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic- Apixaban vs. Warfarin (as reference group).||0.63|0.47|
72611154|NCT02081807|144751078|OTHER||Hazard Ratio (HR)|0.89|||||TWO_SIDED|95.0|0.77|1.04|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis.||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic-Dabigatran vs. Warfarin (as reference group).||1.04|0.77|
72326353|NCT02722408|144175888|OTHER|||||||0.0165||||||Mixed-effects model for repeated measures analysis with change in Apolipoprotein C-II as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84||||0.0165
72326354|NCT02722408|144175889|OTHER|||||||0.4585||||||Mixed-effects model for repeated measures analysis with percent change in Apolipoprotein C-III as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28||||0.4585
72326355|NCT02722408|144175889|OTHER|||||||0.3721||||||Mixed-effects model for repeated measures analysis with percent change in Apolipoprotein C-III as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56||||0.3721
72326356|NCT02722408|144175889|OTHER|||||||0.5305||||||Mixed-effects model for repeated measures analysis with percent change in Apolipoprotein C-III as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84||||0.5305
72611155|NCT02081807|144751078|OTHER||Hazard Ratio (HR)|1.21|||||TWO_SIDED|95.0|1.07|1.36|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis.||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic- Rivaroxaban vs. Warfarin (as reference group).||1.36|1.07|
72611156|NCT02081807|144751078|OTHER||Hazard Ratio (HR)|0.59|||||TWO_SIDED|95.0|0.48|0.72|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis.||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic- Apixaban vs. Warfarin (as reference group).||0.72|0.48|
72326357|NCT02722408|144175890|OTHER|||||||0.2937||||||Mixed-effects model for repeated measures analysis with change in Apolipoprotein C-III as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28||||0.2937
72326358|NCT02722408|144175890|OTHER|||||||0.2182||||||Mixed-effects model for repeated measures analysis with change in Apolipoprotein C-III as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56||||0.2182
72326359|NCT02722408|144175890|OTHER|||||||0.2937||||||Mixed-effects model for repeated measures analysis with change in Apolipoprotein C-III as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84||||0.2937
72326360|NCT02722408|144175891|OTHER|||||||0.0411||||||Mixed-effects model for repeated measures analysis with percent change in Apolipoprotein E as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28||||0.0411
72326361|NCT02722408|144175891|OTHER|||||||0.0192||||||Mixed-effects model for repeated measures analysis with percent change in Apolipoprotein E as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56||||0.0192
72326362|NCT02722408|144175891|OTHER|||||||0.0445||||||Mixed-effects model for repeated measures analysis with percent change in Apolipoprotein E as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84||||0.0445
72611157|NCT02081807|144751079|OTHER||Hazard Ratio (HR)|0.6|||||TWO_SIDED|95.0|0.44|0.8|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis.||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic-Dabigatran vs. Warfarin (as reference group).||0.80|0.44|
72611158|NCT02081807|144751079|OTHER||Hazard Ratio (HR)|1.24|||||TWO_SIDED|95.0|0.98|1.57|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis.||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic- Rivaroxaban vs. Warfarin (as reference group).||1.57|0.98|
72611159|NCT02081807|144751079|OTHER||Hazard Ratio (HR)|0.79|||||TWO_SIDED|95.0|0.54|1.14|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis.||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic- Apixaban vs. Warfarin (as reference group).||1.14|0.54|
72611160|NCT02081807|144751080|OTHER||Hazard Ratio (HR)|0.93|||||TWO_SIDED|95.0|0.79|1.08|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis.||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic-Dabigatran vs. Warfarin (as reference group).||1.08|0.79|
72611161|NCT02081807|144751080|OTHER||Hazard Ratio (HR)|1.19|||||TWO_SIDED|95.0|1.05|1.35|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis.||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic- Rivaroxaban vs. Warfarin (as reference group).||1.35|1.05|
72611162|NCT02081807|144751080|OTHER||Hazard Ratio (HR)|0.54|||||TWO_SIDED|95.0|0.44|0.67|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis.||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic- Apixaban vs. Warfarin (as reference group).||0.67|0.44|
72611163|NCT02081807|144751082|OTHER||Hazard Ratio (HR)|0.68|||||TWO_SIDED|95.0|0.59|78.0|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis.||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic-Dabigatran vs. Warfarin (as reference group).||078|0.59|
72611164|NCT02081807|144751082|OTHER||Hazard Ratio (HR)|1.04|||||TWO_SIDED|95.0|0.93|1.16|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis.||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic- Rivaroxaban vs. Warfarin (as reference group).||1.16|0.93|
72611165|NCT02081807|144751082|OTHER||Hazard Ratio (HR)|0.56|||||TWO_SIDED|95.0|0.47|0.67|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis.||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic- Apixaban vs. Warfarin (as reference group).||0.67|0.47|
72611166|NCT02081807|144751083|OTHER||Hazard Ratio (HR)|0.53|||||TWO_SIDED|95.0|0.34|0.82|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis.||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic-Dabigatran vs. Warfarin (as reference group).||0.82|0.34|
72611167|NCT02081807|144751083|OTHER||Hazard Ratio (HR)|0.84|||||TWO_SIDED|95.0|0.55|1.29|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis.||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic- Rivaroxaban vs. Warfarin (as reference group).||1.29|0.55|
72611168|NCT02081807|144751083|OTHER||Hazard Ratio (HR)|0.76|||||TWO_SIDED|95.0|0.41|1.42|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis.||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic- Apixaban vs. Warfarin (as reference group).||1.42|0.41|
72611169|NCT02081807|144751084|OTHER||Hazard Ratio (HR)|0.83|||||TWO_SIDED|95.0|0.6|1.15|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis.||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic-Dabigatran vs. Warfarin (as reference group).||1.15|0.60|
72611170|NCT02081807|144751084|OTHER||Hazard Ratio (HR)|0.85|||||TWO_SIDED|95.0|0.63|1.14|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis.||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic- Rivaroxaban vs. Warfarin (as reference group).||1.14|0.63|
72611171|NCT02081807|144751084|OTHER||Hazard Ratio (HR)|0.79|||||TWO_SIDED|95.0|0.53|1.18|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis.||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic- Apixaban vs. Warfarin (as reference group).||1.18|0.53|
72611172|NCT02081807|144751085|OTHER||Hazard Ratio (HR)|0.65|||||TWO_SIDED|95.0|0.5|0.84|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis.||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic-Dabigatran vs. Warfarin (as reference group).||0.84|0.50|
72611173|NCT02081807|144751085|OTHER||Hazard Ratio (HR)|0.84|||||TWO_SIDED|95.0|0.69|1.01|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis.||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic-Rivaroxaban vs. Warfarin (as reference group).||1.01|0.69|
72326363|NCT02722408|144175892|OTHER|||||||0.0465||||||Mixed-effects model for repeated measures analysis with change in Apolipoprotein E as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28||||0.0465
72326364|NCT02722408|144175892|OTHER|||||||0.0221||||||Mixed-effects model for repeated measures analysis with change in Apolipoprotein E as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56||||0.0221
72326365|NCT02722408|144175892|OTHER|||||||0.0402||||||Mixed-effects model for repeated measures analysis with change in Apolipoprotein E as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84||||0.0402
72326366|NCT00298389|144175905|SUPERIORITY|||||||0.05||||||calculated|Kruskal-Wallis|||||||0.05
72326367|NCT00298389|144175906|SUPERIORITY|||||||0.05|||||||Kruskal-Wallis|||||||0.05
72326368|NCT00288015|144175907|OTHER|This is a two-stage optimal simon design. If bevacizumab is not effective, there is a 0.050 probability of concluding that it is. If bevacizumab is effective, there is a 0.2000 probability of concluding that it is not.||||||||||||In first stage 12 patients will be entered, if \</=3 patients have PFS time\>3 months p\</=0.22 is likely true. In second stage a total of up to 31 patients data will be analysed. If \>/=10 patients show PFS\</=3 months, it will suggest p\>0.50 is true.|Kaplan-Meier estimate|||This is a two stage optimal simon design testing the Null hypothesis: bevacizumab is not effective with P\<=0.220 and the alternative hypothesis: bevacizumab is effective with P \>=0.450 and has a sample size of 16.96 and a probability of early termination of 0.739. p=probability (progression free survival - PFS time\>/=3 months).|P\<=0.220 is the threshold value of significance that the null hypothesis is true or the alternative hypothesis is true. P Value was not calculated from the data. Median survival time was calculated using a 20% censored Kaplan-Meier table and graph.|||
72418410|NCT00428090|144347172|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.819|TWO_SIDED|95.0|-0.8|0.6||Comparison between Placebo and RSG XR 8 mg at Week 24 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||0.6|-0.8|0.819
72326369|NCT04776161|144175943|SUPERIORITY||Mean Difference (Final Values)|-0.02||||0.78|TWO_SIDED|95.0|-0.16|0.12|||Generalized linear models|Adjusted for age, sex, race||||0.12|-0.16|0.78
72611174|NCT02081807|144751085|OTHER||Hazard Ratio (HR)|0.53|||||TWO_SIDED|95.0|0.37|0.76|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis.||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic- Apixaban vs. Warfarin (as reference group).||0.76|0.37|
72326370|NCT04776161|144175943|SUPERIORITY||Mean Difference (Final Values)|0.02||||0.79|TWO_SIDED|95.0|-0.1|0.13|||Generalized linear models|Adjusted for age, sex, race||||0.13|-0.10|0.79
72326371|NCT04776161|144175944|SUPERIORITY||Mean Difference (Final Values)|0.47||||0.22|TWO_SIDED|95.0|-0.28|1.22|||Generalized linear models|Adjusted for age, sex, race and baseline uric acid level.||||1.22|-0.28|0.22
72326372|NCT04776161|144175944|SUPERIORITY||Mean Difference (Final Values)|0.47||||0.24|TWO_SIDED|95.0|-0.33|1.26|||Generalized linear models|Adjusted for age, sex, race and baseline uric acid level||||1.26|-0.33|0.24
72326373|NCT04552041|144175945|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||This analysis applies to ∆ between baseline and 24 weeks row.||||<0.0001
72326374|NCT04552041|144175946|SUPERIORITY|||||||0.0028|||||||Wilcoxon (Mann-Whitney)|||This analysis applies to ∆ between baseline and 24 weeks row.||||0.0028
72326375|NCT04552041|144175946|SUPERIORITY|||||||0.1739|||||||Wilcoxon (Mann-Whitney)|||"This analysis applies to domain Delusional ideas ∆ between baseline and 24 weeks row."||||0.1739
72326376|NCT04552041|144175946|SUPERIORITY|||||||0.0559|||||||Wilcoxon (Mann-Whitney)|||"This analysis applies to domain Hallucinations ∆ between baseline and 24 weeks row."||||0.0559
72326377|NCT04552041|144175946|SUPERIORITY|||||||0.0174|||||||Wilcoxon (Mann-Whitney)|||"This analysis applies to domain Agitation ∆ between baseline and 24 weeks row."||||0.0174
72326378|NCT04552041|144175946|SUPERIORITY|||||||0.333|||||||Wilcoxon (Mann-Whitney)|||"This analysis applies to domain Aggression ∆ between baseline and 24 weeks row."||||0.3330
72326379|NCT04552041|144175946|SUPERIORITY|||||||0.1037|||||||Wilcoxon (Mann-Whitney)|||"This analysis applies to domain Dysphoria ∆ between baseline and 24 weeks row."||||0.1037
72326380|NCT04552041|144175946|SUPERIORITY|||||||0.0329|||||||Wilcoxon (Mann-Whitney)|||"This analysis applies to domain Anxiety ∆ between baseline and 24 weeks row."||||0.0329
72326381|NCT04552041|144175946|SUPERIORITY|||||||0.27|||||||Wilcoxon (Mann-Whitney)|||"This analysis applies to domain Euphoria ∆ between baseline and 24 weeks row."||||0.2700
72326382|NCT04552041|144175946|SUPERIORITY|||||||0.0557|||||||Wilcoxon (Mann-Whitney)|||"This analysis applies to domain Apathy ∆ between baseline and 24 weeks row."||||0.0557
72326383|NCT04552041|144175946|SUPERIORITY|||||||0.982|||||||Wilcoxon (Mann-Whitney)|||"This analysis applies to domain Disinhibition ∆ between baseline and 24 weeks row."||||0.9820
72326384|NCT04552041|144175946|SUPERIORITY|||||||0.4626|||||||Wilcoxon (Mann-Whitney)|||"This analysis applies to domain Irritability ∆ between baseline and 24 weeks row."||||0.4626
72326385|NCT04552041|144175946|SUPERIORITY|||||||0.0006|||||||Wilcoxon (Mann-Whitney)|||"This analysis applies to domain Aberrant motor behaviour ∆ between baseline and 24 weeks row."||||0.0006
72326386|NCT04552041|144175946|SUPERIORITY|||||||0.3725|||||||Wilcoxon (Mann-Whitney)|||"This analysis applies to domain Sleep disorders ∆ between baseline and 24 weeks row."||||0.3725
72326387|NCT04552041|144175946|SUPERIORITY|||||||0.1013|||||||Wilcoxon (Mann-Whitney)|||"This analysis applies to domain Appetite disorders ∆ between baseline and 24 weeks row."||||0.1013
72326388|NCT04552041|144175946|SUPERIORITY|||||||0.0432|||||||Wilcoxon (Mann-Whitney)|||"This analysis applies to domain Aberrant vocalizations ∆ between baseline and 24 weeks row."||||0.0432
72326389|NCT04552041|144175947|SUPERIORITY|||||||0.0316|||||||Wilcoxon (Mann-Whitney)|||This analysis applies to ∆ between baseline and 12 weeks row.||||0.0316
72326390|NCT04552041|144175948|SUPERIORITY|||||||0.1483|||||||Wilcoxon (Mann-Whitney)|||This analysis applies to ∆ between baseline and 12 weeks row.||||0.1483
72326391|NCT04552041|144175949|SUPERIORITY|||||||0.0018|||||||Wilcoxon (Mann-Whitney)|||This analysis applies to Therapeutic effect row.||||0.0018
72418411|NCT00428090|144347172|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5||||0.306|TWO_SIDED|95.0|-1.5|0.5||Comparison between Placebo and Donepezil 10 mg at Week 24 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||0.5|-1.5|0.306
72418412|NCT00428090|144347173|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.03||||0.199|TWO_SIDED|95.0|-0.01|0.07||Comparison between Placebo and RSG XR 2 mg at Week 12 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||0.07|-0.01|0.199
72611175|NCT02081807|144751086|OTHER||Hazard Ratio (HR)|0.65|||||TWO_SIDED|95.0|0.47|0.88|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis.||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic-Dabigatran vs. Warfarin (as reference group).||0.88|0.47|
72418413|NCT00428090|144347173|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.04||||0.094|TWO_SIDED|95.0|-0.01|0.08||Comparison between Placebo and RSG XR 8 mg at Week 12 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||0.08|-0.01|0.094
72611176|NCT02081807|144751086|OTHER||Hazard Ratio (HR)|0.82|||||TWO_SIDED|95.0|0.65|1.04|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis.||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic- Rivaroxaban vs. Warfarin (as reference group).||1.04|0.65|
72611177|NCT02081807|144751086|OTHER||Hazard Ratio (HR)|0.6|||||TWO_SIDED|95.0|0.39|0.92|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis.||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic- Apixaban vs. Warfarin (as reference group).||0.92|0.39|
72611178|NCT02081807|144751087|OTHER||Hazard Ratio (HR)|0.7|||||TWO_SIDED|95.0|0.47|1.04|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis.||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic- Dabigatran vs. Warfarin (as reference group).||1.04|0.47|
72611179|NCT02081807|144751087|OTHER||Hazard Ratio (HR)|0.79|||||TWO_SIDED|95.0|0.6|1.05|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis.||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic- Rivaroxaban vs. Warfarin (as reference group).||1.05|0.60|
72611180|NCT02081807|144751087|OTHER||Hazard Ratio (HR)|0.42|||||TWO_SIDED|95.0|0.24|0.73|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis.||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic- Apixaban vs. Warfarin (as reference group).||0.73|0.24|
72611181|NCT00091819|144751109|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin of 10% was specified based on historical regulatory precedent.|Risk Difference (RD)|1.0||||||95.0|-4.8|6.8||p-values were not calculated in deference to confidence intervals.|||"Statistical analysis applies to cure"|||6.8|-4.8|
72611182|NCT02592824|144751179|SUPERIORITY|||||||0.086|||||||t-test, 2 sided|||Two-sided Student's t-test used for sample size estimation which was based on data from the first GLUTAMICS trial.||||0.086
72611183|NCT02592824|144751180|SUPERIORITY|||||||0.97|||||||t-test, 2 sided|||||||0.97
72611184|NCT02592824|144751181|SUPERIORITY|||||||0.36|||||||t-test, 2 sided|||||||0.36
72611185|NCT02592824|144751186|SUPERIORITY|||||||0.007|||||||t-test, 2 sided|||||||0.007
72611186|NCT01394276|144751197|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0237|||||||Exact binomial proportion test|||||||0.0237
72611187|NCT01394276|144751198|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0003|||||||Exact binomial proportion test|||||||0.0003
72611188|NCT01394276|144751210|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.0||||0.808|TWO_SIDED|95.0|-0.3|0.4|||t-test, 2 sided|||At Baseline: mean difference of scores of DAS28 between the two groups was calculated.||0.4|-0.3|0.8080
72611189|NCT01394276|144751210|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.1||||0.4884|TWO_SIDED|95.0|-0.5|0.3|||t-test, 2 sided|||At Month 1: mean difference of scores of DAS28 between the two groups was calculated.||0.3|-0.5|0.4884
72611190|NCT01394276|144751210|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.3||||0.0947|TWO_SIDED|95.0|-0.7|0.1|||t-test, 2 sided|||At Month 2: mean difference of scores of DAS28 between the two groups was calculated.||0.1|-0.7|0.0947
72611191|NCT01394276|144751210|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.0||||0.8181|TWO_SIDED|95.0|-0.4|0.3|||t-test, 2 sided|||At Month 4: mean difference of scores of DAS28 between the two groups was calculated.||0.3|-0.4|0.8181
72611192|NCT01394276|144751210|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.0||||0.9721|TWO_SIDED|95.0|-0.4|0.3|||t-test, 2 sided|||At Month 6: mean difference of scores of DAS28 between the two groups was calculated.||0.3|-0.4|0.9721
72611193|NCT01394276|144751210|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.1||||0.5832|TWO_SIDED|95.0|-0.3|0.5|||t-test, 2 sided|||At Month 12: mean difference of scores of DAS28 between the two groups was calculated.||0.5|-0.3|0.5832
72611194|NCT01394276|144751211|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|3.5||||0.4211|TWO_SIDED|95.0|-5.1|12.2|||t-test, 2 sided|||At Baseline: mean difference of scores of fatigue between the two groups was calculated.||12.2|-5.1|0.4211
72611195|NCT01394276|144751211|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|2.1||||0.6749|TWO_SIDED|95.0|-7.9|12.1|||t-test, 2 sided|||At Month 1: mean difference of scores of fatigue between the two groups was calculated.||12.1|-7.9|0.6749
72611196|NCT01394276|144751211|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|6.4||||0.1817|TWO_SIDED|95.0|-3.0|15.9|||t-test, 2 sided|||At Month 2: mean difference of scores of fatigue between the two groups was calculated.||15.9|-3.0|0.1817
72326392|NCT04552041|144175949|SUPERIORITY|||||||0.4733|||||||Wilcoxon (Mann-Whitney)|||This analysis applies to Side effects row.||||0.4733
72611197|NCT01394276|144751211|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|2.8||||0.5182|TWO_SIDED|95.0|-5.8|11.4|||t-test, 2 sided|||At Month 4: mean difference of scores of fatigue between the two groups was calculated.||11.4|-5.8|0.5182
72611198|NCT01394276|144751211|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|13.7||||0.0025|TWO_SIDED|95.0|4.9|22.6|||t-test, 2 sided|||At Month 6: mean difference of scores of fatigue between the two groups was calculated.||22.6|4.9|0.0025
72611199|NCT01394276|144751211|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|3.9||||0.354|TWO_SIDED|95.0|-4.4|12.1|||t-test, 2 sided|||At Month 12: mean difference of scores of fatigue between the two groups was calculated.||12.1|-4.4|0.3540
72611200|NCT01394276|144751212|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.0||||0.7343|TWO_SIDED|95.0|-0.2|0.2|||t-test, 2 sided|||At Baseline: mean difference of scores of HAQ between the two groups was calculated.||0.2|-0.2|0.7343
72611201|NCT01394276|144751212|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.2||||0.1098|TWO_SIDED|95.0|-0.4|0.0|||t-test, 2 sided|||At Month 1: mean difference of scores of HAQ between the two groups was calculated.||0.0|-0.4|0.1098
72611202|NCT01394276|144751212|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.1||||0.4932|TWO_SIDED|95.0|-0.3|0.2|||t-test, 2 sided|||At Month 2: mean difference of scores of HAQ between the two groups was calculated.||0.2|-0.3|0.4932
72611203|NCT01394276|144751212|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.1||||0.2468|TWO_SIDED|95.0|-0.4|0.1|||t-test, 2 sided|||At Month 4: mean difference of scores of HAQ between the two groups was calculated.||0.1|-0.4|0.2468
72611204|NCT01394276|144751212|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.0||||0.9639|TWO_SIDED|95.0|-0.2|0.2|||t-test, 2 sided|||At Month 6: mean difference of scores of HAQ between the two groups was calculated.||0.2|-0.2|0.9639
72611205|NCT01394276|144751212|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.1||||0.6696|TWO_SIDED|95.0|-0.2|0.3|||t-test, 2 sided|||At Month 12: mean difference of scores of HAQ between the two groups was calculated.||0.3|-0.2|0.6696
72611206|NCT00560404|144751245|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Mean Hb within target range during efficacy evaluation period within plus or minus 1 g/dL of their reference Hb and between the target range with a non-inferiority limit of -0.15.|Difference of response rates|-0.02|||||TWO_SIDED|95.0|-0.25|0.2||||||||0.20|-0.25|
72611207|NCT00471497|144751271|OTHER||Difference in response rate|22.1|||<|0.0001|TWO_SIDED|95.0|14.5|29.6|||Cochran-Mantel-Haenszel|||||29.6|14.5|<0.0001
72611208|NCT00471497|144751271|OTHER||Difference in response rate|20.4|||<|0.0001|TWO_SIDED|95.0|12.9|28.0|||Cochran-Mantel-Haenszel|||||28.0|12.9|<0.0001
72611209|NCT00471497|144751272|OTHER||Difference in response rate|14.8|||||TWO_SIDED|95.0|2.1|27.5||||||(Low)||27.5|2.1|
72611210|NCT00471497|144751272|OTHER||Difference in response rate|27.4|||||TWO_SIDED|95.0|14.6|40.2||||||(Low)||40.2|14.6|
72611211|NCT00471497|144751272|OTHER||Difference in response rate|27.7|||||TWO_SIDED|95.0|15.0|40.4||||||(Intermediate)||40.4|15.0|
72611212|NCT00471497|144751272|OTHER||Difference in response rate|17.2|||||TWO_SIDED|95.0|4.6|29.8||||||(Intermediate)||29.8|4.6|
72611213|NCT00471497|144751272|OTHER||Difference in response rate|24.4|||||TWO_SIDED|95.0|10.7|38.1||||||(High)||38.1|10.7|
72611214|NCT00471497|144751272|OTHER||Difference in response rate|15.4|||||TWO_SIDED|95.0|2.1|28.6||||||(High)||28.6|2.1|
72611215|NCT00471497|144751273|OTHER||Difference in response rate|21.3|||||TWO_SIDED|95.0|13.9|28.8||||||||28.8|13.9|
72611216|NCT00471497|144751273|OTHER||Difference in response rate|18.7|||||TWO_SIDED|95.0|11.3|26.0||||||||26.0|11.3|
72611217|NCT00471497|144751275|OTHER||Absolute difference|-1.6||||0.6987|TWO_SIDED|95.0|-9.8|6.6|||Cochran-Mantel-Haenszel|||||6.6|-9.8|0.6987
72611218|NCT00392223|144751302|NON_INFERIORITY_OR_EQUIVALENCE|Analysis performed to assess non-inferiority by calculation \& examination of 95% CI. Analysis conducted via analysis of covariance (ANCOVA) including corresponding baseline value and centre as covariates. Non-inferiority margin was chosen as largest clinically acceptable difference. This was set as difference of 3 in GAGS global score. Azithromycin declared non-inferior to minocycline when two-sided 95% confidence interval for difference lied entirely to right of non-inferiority margin.|Mean Difference (Final Values)|-0.47||||||95.0|-2.48|1.54|||||Comparison between treatment groups was performed using an analysis of covariance (ANCOVA) method, with treatment, center, and baseline value GAGS global score included as covariates.|||1.54|-2.48|
72611219|NCT00392223|144751306|NON_INFERIORITY_OR_EQUIVALENCE|Analysis performed to assess non-inferiority by calculation \& examination of 95% CI. Analysis conducted via analysis of covariance (ANCOVA) including corresponding baseline value and centre as covariates. Non-inferiority margin was chosen as largest clinically acceptable difference. This was set as difference of 3 in GAGS global score. Azithromycin declared non-inferior to minocycline when two-sided 95% confidence interval for difference lied entirely to right of non-inferiority margin.|Mean Difference (Final Values)|-0.87||||||95.0|-2.58|0.84|||||ANCOVA adjusted for baseline, center and treatment.|||0.84|-2.58|
72326393|NCT04552041|144175949|SUPERIORITY|||||||0.0035|||||||Wilcoxon (Mann-Whitney)|||This analysis applies to Efficiency index row.||||0.0035
72611220|NCT01991795|144751308|SUPERIORITY||Hazard Ratio (HR)|0.9||||0.0378|TWO_SIDED|95.0|0.81|0.99||The hypothesis will be tested at the 4.96% two-sided significance level to account for the planned interim analysis with the overall type I error preserved at 5%. A hierarchical test sequence will be used to address the issue of multiple testing|Regression, Cox|||||0.99|0.81|0.0378
72326394|NCT00661830|144175950|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.281|||||TWO_SIDED|95.0|0.811|2.023|||Regression, Cox|||||2.023|0.811|
72326395|NCT00661830|144175951|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.2|||||TWO_SIDED|95.0|0.747|1.927|||Regression, Cox|||||1.927|0.747|
72326396|NCT01669902|144176002|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Wilcoxon signed rank test|||Change at Month 3||||<0.0001
72418414|NCT00428090|144347173|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.03||||0.187|TWO_SIDED|95.0|-0.02|0.09||Comparison between Placebo and Donepezil 10 mg at Week 12 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||0.09|-0.02|0.187
72418415|NCT00428090|144347173|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.03||||0.134|TWO_SIDED|95.0|-0.01|0.07||Comparison between Placebo and RSG XR 2 mg at Week 24 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||0.07|-0.01|0.134
72418416|NCT00428090|144347173|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.958|TWO_SIDED|95.0|-0.05|0.05||Comparison between Placebo and RSG XR 8 mg at Week 24 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||0.05|-0.05|0.958
72418417|NCT00428090|144347173|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.02||||0.374|TWO_SIDED|95.0|-0.03|0.07||Comparison between Placebo and Donepezil 10 mg at Week 24 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||0.07|-0.03|0.374
72611221|NCT01991795|144751309|SUPERIORITY||Hazard Ratio (HR)|1.02||||0.7883|TWO_SIDED|95.0|0.88|1.18||The hypothesis will be tested at the 4.96% two-sided significance level to account for the planned interim analysis with the overall type I error preserved at 5%. A hierarchical test sequence will be used to address the issue of multiple testing|Regression, Cox|||||1.18|0.88|0.7883
72418418|NCT00428090|144347174|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.2||||0.493|TWO_SIDED|95.0|-4.6|2.2||Comparison between Placebo and RSG XR 2 mg at Week 12 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||2.2|-4.6|0.493
72418419|NCT00428090|144347174|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3||||0.883|TWO_SIDED|95.0|-3.2|3.7||Comparison between Placebo and RSG XR 8 mg at Week 12 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||3.7|-3.2|0.883
72611222|NCT01991795|144751310|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.0294|TWO_SIDED|95.0|0.71|0.98||The hypothesis will be tested at the 4.96% two-sided significance level to account for the planned interim analysis with the overall type I error preserved at 5%. A hierarchical test sequence will be used to address the issue of multiple testing|Regression, Cox|||||0.98|0.71|0.0294
72611223|NCT01991795|144751311|SUPERIORITY||Hazard Ratio (HR)|0.8||||0.0375|TWO_SIDED|95.0|0.64|0.99||The hypothesis will be tested at the 4.96% two-sided significance level to account for the planned interim analysis with the overall type I error preserved at 5%. A hierarchical test sequence will be used to address the issue of multiple testing|Regression, Cox|||||0.99|0.64|0.0375
72326397|NCT01669902|144176002|SUPERIORITY_OR_OTHER|||||||0.0357|TWO_SIDED||||||Wilcoxon signed rank test|||Change at Month 6||||0.0357
72611224|NCT01991795|144751312|SUPERIORITY||Hazard Ratio (HR)|0.98||||0.6846|TWO_SIDED|95.0|0.87|1.1|||Regression, Cox|||||1.10|0.87|0.6846
72611225|NCT01991795|144751313|SUPERIORITY||Hazard Ratio (HR)|2.32|||<|0.0001|TWO_SIDED|95.0|1.82|2.94|||Regression, Cox|||||2.94|1.82|<0.0001
72611226|NCT01991795|144751314|SUPERIORITY||Hazard Ratio (HR)|2.49|||<|0.0001|TWO_SIDED|95.0|2.02|3.07|||Regression, Cox|||||3.07|2.02|<0.0001
72611227|NCT01991795|144751315|SUPERIORITY||Hazard Ratio (HR)|2.41|||<|0.0001|TWO_SIDED|95.0|1.98|2.93|||Regression, Cox|||||2.93|1.98|<0.0001
72611228|NCT01991795|144751316|SUPERIORITY||Hazard Ratio (HR)|4.04|||<|0.0001|TWO_SIDED|95.0|3.32|4.92|||Regression, Cox|||||4.92|3.32|<0.0001
72418420|NCT00428090|144347174|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.0||||0.13|TWO_SIDED|95.0|-9.3|1.2||Comparison between Placebo and Donepezil 10 mg at Week 12 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||1.2|-9.3|0.130
72418421|NCT00428090|144347174|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.6||||0.198|TWO_SIDED|95.0|-6.6|1.4||Comparison between Placebo and RSG XR 2 mg at Week 24 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||1.4|-6.6|0.198
72418422|NCT00428090|144347174|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.7||||0.441|TWO_SIDED|95.0|-5.9|2.6||Comparison between Placebo and RSG XR 8 mg at Week 24 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||2.6|-5.9|0.441
72418423|NCT00428090|144347174|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4||||0.898|TWO_SIDED|95.0|-5.8|5.1||Comparison between Placebo and Donepezil 10 mg at Week 24 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||5.1|-5.8|0.898
72418424|NCT00428090|144347176|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.1||||0.027|TWO_SIDED|95.0|-2.1|-0.1||Comparison between Placebo and RSG XR 2 mg at Week 12 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||-0.1|-2.1|0.027
72418425|NCT00428090|144347176|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6||||0.278|TWO_SIDED|95.0|-1.6|0.5||Comparison between Placebo and RSG XR 8 mg at Week 12 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||0.5|-1.6|0.278
72418426|NCT00428090|144347176|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.993|TWO_SIDED|95.0|-1.2|1.1||Comparison between Placebo and Donepezil 10 mg at Week 12 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||1.1|-1.2|0.993
72418427|NCT00428090|144347176|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8||||0.196|TWO_SIDED|95.0|-2.0|0.4||Comparison between Placebo and RSG XR 2 mg at Week 24 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||0.4|-2.0|0.196
72418428|NCT00428090|144347176|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6||||0.353|TWO_SIDED|95.0|-1.9|0.7||Comparison between Placebo and RSG XR 8 mg at Week 24 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||0.7|-1.9|0.353
72418429|NCT00428090|144347176|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6||||0.427|TWO_SIDED|95.0|-2.2|0.9||Comparison between Placebo and Donepezil 10 mg at Week 24 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||0.9|-2.2|0.427
72418430|NCT00428090|144347177|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.886|TWO_SIDED|95.0|-0.7|0.6|||ANCOVA|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||0.6|-0.7|0.886
72418431|NCT00428090|144347177|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.71|TWO_SIDED|95.0|-0.8|0.6|||ANCOVA|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||0.6|-0.8|0.710
72418432|NCT00428090|144347177|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.0||||0.03|TWO_SIDED|95.0|0.1|1.8|||ANCOVA|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||1.8|0.1|0.030
72418433|NCT00428090|144347178|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||0.139|TWO_SIDED|95.0|0.0|0.2|||ANCOVA|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||0.2|-0.0|0.139
72611229|NCT06119854|144751328|OTHER||Risk Ratio (RR)|1.207|||||TWO_SIDED|95.0|0.406|3.59|||||The CBT arm is the numerator and the standard arm is the denominator.|||3.590|0.406|
72611230|NCT06119854|144751328|OTHER||Risk Difference (RD)|0.003|||||TWO_SIDED|95.0|-0.013|0.018|||||RD was calculated as the risk in the CBT arm minus the risk in the standard arm.|||0.018|-0.013|
72611231|NCT06119854|144751328|OTHER||Risk Ratio (RR)|0.687|||||TWO_SIDED|95.0|0.194|2.436|||||The inoculation arm is the numerator and the standard arm is the denominator.|||2.436|0.194|
72611232|NCT06119854|144751328|OTHER||Risk Difference (RD)|-0.004|||||TWO_SIDED|95.0|-0.018|0.01|||||RD was calculated as the risk in the inoculation arm minus the risk in the standard arm.|||0.010|-0.018|
72611233|NCT06119854|144751329|OTHER||Risk Ratio (RR)|0.992|||||TWO_SIDED|95.0|0.785|1.253|||||The CBT arm is the numerator and the standard arm is the denominator.|||1.253|0.785|
72418434|NCT00428090|144347178|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.846|TWO_SIDED|95.0|-0.1|0.1|||ANCOVA|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||0.1|-0.1|0.846
72418435|NCT00428090|144347178|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.864|TWO_SIDED|95.0|-0.1|0.2|||ANCOVA|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||0.2|-0.1|0.864
72418436|NCT00361140|144347189|SUPERIORITY_OR_OTHER|||||||0.007||95.0|||||Chi-squared|||||||.007
72418437|NCT00361140|144347190|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|6.27||||0.07|TWO_SIDED|95.0|0.92|42.48|||Gray|Gray RJ. A class of K-sample tests for comparing the cumulative incidence of a competing risk. Ann Stat. 1988;16:1141-1154.||Sample size: dependent on dose escalation. Once the maximum tolerated dose (MTD) is reached, a total of 30 patients will be accrued to that level. If maximally tolerated AUC is level 1, a total of 30 patients will be treated on this level using tacrolimus and methotrexate as GVHD prophylaxis. This will provide 95% confidence intervals for 100-day non-relapse mortality and non-fatal toxicities with ½ widths not exceeding 0.18. Hazard ratios were calculated per the method of Gray (reference given)||42.48|0.92|.07
72418438|NCT00993655|144347216|SUPERIORITY|||||||0.065|||||||Cochran-Mantel-Haenszel|adjusting for stratification factors at randomization||Assume that the 9-month PD rate in IV arm (Arm 1) will be 40% (based on experience with data from NCIC CTG OV.16 and that of NCRI UK). The target sample size of 200 will enable the detection of a 19% difference between Arms 1 and 3 in 9 month progression disease rate post randomization with 80% power at two-sided 0.05 level.||||0.065
72418439|NCT00993655|144347217|SUPERIORITY||Hazard Ratio (HR)|1.22||||0.27|TWO_SIDED|95.0|0.85|1.75|||Log Rank|Adjusting for stratification factors at randomization||||1.75|0.85|0.27
72611234|NCT06119854|144751329|OTHER||Risk Difference (RD)|-0.003|||||TWO_SIDED|95.0|-0.063|0.058|||||RD was calculated as the risk in the CBT arm minus the risk in the standard arm.|||0.058|-0.063|
72611235|NCT06119854|144751329|OTHER||Risk Ratio (RR)|1.227|||||TWO_SIDED|95.0|0.981|1.534|||||The inoculation arm is the numerator and the standard arm is the denominator.|||1.534|0.981|
72418440|NCT00993655|144347218|SUPERIORITY||Hazard Ratio (HR)|1.25||||0.4|TWO_SIDED|95.0|0.74|2.13|||Log Rank|Adjusting for stratification factors at randomization||||2.13|0.74|0.40
72418441|NCT04605978|144347219|SUPERIORITY||Mean Difference (Net)|2.44|||||TWO_SIDED|95.0|-0.61|5.49|||||Missing data and data post intercurrent event were imputed for the statistical analysis as specified in the statistical analysis plan.|||5.49|-0.61|
72418442|NCT03813238|144347227|SUPERIORITY||LS mean difference|-1.2||||0.335|TWO_SIDED|95.0|-3.49|1.19|||Mixed Models Analysis|||The LS mean of the change in MDCRS part II total score from baseline to Week 15 was compared (TEV-50717 arm versus placebo) using a 1-sided test for superiority at a nominal significance level of α=0.025.||1.19|-3.49|0.335
72418443|NCT01644734|144347257|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||Null hypothesis: no change in the total CAT score between baseline and after 3 months.||||<0.001
72418444|NCT04393441|144347259|NON_INFERIORITY|MMRM with fixed effects=treatment, visit, visit by treatment interaction,Baseline total staining stratum(TSS),and Baseline TSS by visit interaction.|Least Squares Mean Difference|1.1|STANDARD_ERROR_OF_MEAN|0.57||0.0475|TWO_SIDED|95.0|0.01|2.27|||MMRM|||Change from Baseline in Total Staining Score at Day 90: The null hypothesis was that 011516X tear formulation was to be considered noninferior to Systane Ultra MD if the upper limit of 2-sided confidence interval (CI) was less than 2.3 units.||2.27|0.01|0.0475
72418445|NCT04393441|144347260|OTHER|No formal hypothesis was planned. The p-value for treatment differences is reported for reference.|Least Squares Mean Difference|2.1|STANDARD_ERROR_OF_MEAN|16.32||0.9001|TWO_SIDED|95.0|-30.03|34.14|||MMRM|MMRM with fixed effects=treatment, visit, visit by treatment interaction, Baseline TSS, and Baseline TSS by visit interaction.||||34.14|-30.03|0.9001
72418446|NCT01215292|144347265|NON_INFERIORITY_OR_EQUIVALENCE|80% power to detect 20% difference in ITT|||||<|0.05|TWO_SIDED|95.0|||||Kruskal-Wallis|||||||<0.05
72418447|NCT01215292|144347266|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0|||||Kruskal-Wallis|||||||<0.05
72418448|NCT01215292|144347267|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0|||||Kruskal-Wallis|||||||<0.05
72418449|NCT00689221|144347268|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.021||||0.8623|TWO_SIDED|95.0|0.808|1.291||P-value is not adjusted for multiple testing.|Log Rank|||||1.291|0.808|0.8623
72418450|NCT01812655|144347283|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|23.7||||0.029|TWO_SIDED|95.0|2.4|45.0|||Regression, Linear||Mean difference = PD group - VR group|||45.0|2.4|0.029
72418451|NCT01812655|144347283|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.7||||0.32|TWO_SIDED|95.0|-9.5|28.9|||Regression, Linear||Mean difference = VR group - SC group|||28.9|-9.5|0.32
72418452|NCT01812655|144347284|SUPERIORITY_OR_OTHER||Semipartial correlation|0.223||||0.26||95.0|||||Semipartial correlation||Semipartial correlation between desire for distraction and STAIC State Anxiety measured at Baseline for all participants|||||.26
72418453|NCT01812655|144347284|SUPERIORITY_OR_OTHER||Semipartial correlation|0.119||||0.59||95.0|||||Semipartial correlation||Semipartial correlation between desire for distraction and STAIC Trait Anxiety measured at Baseline for all participants|||||.59
72611236|NCT06119854|144751329|OTHER||Risk Difference (RD)|0.07|||||TWO_SIDED|95.0|0.008|0.133|||||RD was calculated as the risk in the inoculation arm minus the risk in the standard arm.|||0.133|0.008|
72611237|NCT06119854|144751330|OTHER||Risk Ratio (RR)|1.063|||||TWO_SIDED|95.0|0.74|1.527|||||CBT group represents the numerator and standard (conventional) represents the denominator|||1.527|0.740|
72611238|NCT06119854|144751330|OTHER||Risk Difference (RD)|0.008|||||TWO_SIDED|95.0|-0.037|0.053|||||RD was calculated as the risk in the CBT arm minus the risk in the standard arm|||0.053|-0.037|
72611239|NCT06119854|144751330|OTHER||Risk Ratio (RR)|1.262|||||TWO_SIDED|95.0|0.892|1.784|||||The inoculation arm is the numerator and the standard arm is the denominator.|||1.784|0.892|
72611240|NCT06119854|144751330|OTHER||Risk Difference (RD)|0.034|||||TWO_SIDED|95.0|-0.013|0.08|||||RD was calculated as the risk in the inoculation arm minus the risk in the standard arm.|||0.080|-0.013|
72418454|NCT01812655|144347284|SUPERIORITY_OR_OTHER||Semipartial correlation|-0.059||||0.6||95.0|||||Semipartial correlation||Semipartial correlation between desire for distraction and Procedural Pain (Outcome Measure #1) for all participants|||||.60
72418455|NCT01812655|144347285|SUPERIORITY_OR_OTHER||semipartial correlation|-0.276||||0.15||95.0|||||Semipartial Correlation||Semipartial correlation between Engagement with Distraction and STAIC State Anxiety measured at Baseline for all participants|||||0.15
72418456|NCT01812655|144347285|SUPERIORITY_OR_OTHER||Semipartial correlation|-0.347||||0.18||95.0|||||Semipartial correlation||Semipartial correlation between Engagement with Distraction and STAIC Trait Anxiety measured at Baseline for all participants|||||0.18
72418457|NCT01812655|144347285|SUPERIORITY_OR_OTHER||Semipartial correlation|0.21||||0.054||95.0|||||Semipartial correlation||Semipartial correlation between Engagement with Distraction and Procedural Pain (Outcome Measure #1) for all participants|||||0.054
72418458|NCT01812655|144347285|SUPERIORITY_OR_OTHER||Semipartial Correlation|-0.102||||0.61||95.0|||||Semipartial Correlation||Semipartial correlation between Belief in Distraction's Efficacy and STAIC State Anxiety measured at Baseline for all participants|||||0.61
72418459|NCT01812655|144347285|SUPERIORITY_OR_OTHER||Semipartial Correlation|-0.622||||0.007||95.0|||||Semipartial Correlation||Semipartial correlation between Belief in Distraction's Efficacy and STAIC Trait Anxiety measured at Baseline for all participants|||||0.007
72418460|NCT01812655|144347285|SUPERIORITY_OR_OTHER||Semipartial correlation|-0.217||||0.045||95.0|||||Semipartial correlation||Semipartial correlation between Belief in Distraction's Efficacy and Procedural Pain (Outcome Measure #1) for all participants|||||0.045
72418461|NCT01596582|144347291|SUPERIORITY|||||||0.4|||||||Chi-squared|||||||0.40
72418462|NCT01596582|144347292|SUPERIORITY|||||||0.51|||||||Chi-squared|||||||0.51
72418463|NCT01596582|144347293|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
72418464|NCT01596582|144347294|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
72418465|NCT01596582|144347295|SUPERIORITY|||||||0.004|||||||Chi-squared|||||||0.004
72418466|NCT01596582|144347296|SUPERIORITY||||||>|0.05||||||The p-value for each comparison was non-significanct.|Wilcoxon (Mann-Whitney)|||||||>0.05
72611241|NCT06119854|144751331|OTHER||Risk Ratio (RR)|1.131|||||TWO_SIDED|95.0|0.911|1.406|||||CBT arm is the numerator and the standard arm is the denominator.|||1.406|0.911|
72418467|NCT01596582|144347297|SUPERIORITY|||||||0.51|||||||Chi-squared|||||||0.51
72418468|NCT01596582|144347298|SUPERIORITY|||||||0.62|||||||Fisher Exact|||||||0.62
72418469|NCT01596582|144347299|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.00
72418470|NCT01596582|144347300|SUPERIORITY|||||||0.39|||||||Fisher Exact|||||||0.39
72418471|NCT04672941|144347301|OTHER|Mixed model for repeated measurements (MMRM) assuming random missingness was fitted. The dependent variable was the CAT score at each visit. Visit, Global Initiative for Chronic Obstructive Lung Disease (GOLD) group, smoking habits, pack years, sex, age, and comorbidities appearing at a rate greater than 5% were entered as covariates.|Score on a scale|-5.28|||||TWO_SIDED|95.0|-5.67|-4.89|||||Least Square Mean for Visit, change from baseline (3 months - baseline) total CAT Score estimates.|||-4.89|-5.67|
72418472|NCT04672941|144347302|OTHER|The logistic generalized estimating equations (GEE) model with CAT response \>= 10 as dependent variable. Visit, Chronic Obstructive Lung Disease (GOLD) group, smoking habits, pack years, sex, age, and comorbidities appearing at a rate greater than 5% were entered as covariates and unstructured covariance matrix was used.|Odds Ratio (OR)|7.186|||<|0.001|TWO_SIDED|95.0|5.745|8.987|||Regression, Logistic||Odds ratio for Visit.|||8.987|5.745|< 0.001
72418473|NCT04672941|144347303|OTHER|Mixed model for repeated measurements (MMRM) assuming random missingness was fitted. The dependent variable was EQ-VAS score. Visit, Global Initiative for Chronic Obstructive Lung Disease (GOLD) group, smoking habits, pack years, sex, age, and comorbidities appearing at a rate greater than 5% were entered as covariates.|Score on a scale|11.8|||||TWO_SIDED|95.0|11.0|12.6|||||Least Square Mean for Visit, mean change from Baseline (3 months - baseline) of EQ-VAS based on non-responder imputation.|||12.60|11.00|
72418474|NCT04672941|144347304|OTHER|The logistic generalized estimating equations (GEE) model with mobility as dependent variable. Visit, Chronic Obstructive Lung Disease (GOLD) group, smoking habits, pack years, sex, age, and comorbidities appearing at a rate greater than 5% were entered as covariates and unstructured covariance matrix was used.|Odds Ratio (OR)|4.48|||<|0.001|TWO_SIDED|95.0|3.9|5.14|||Regression, Logistic||Odds ratio for Visit (3 months / baseline (reference)).|||5.14|3.90|< 0.001
72418475|NCT04672941|144347305|OTHER|The logistic generalized estimating equations (GEE) model with self-care as dependent variable. Visit, Chronic Obstructive Lung Disease (GOLD) group, smoking habits, pack years, sex, age, and comorbidities appearing at a rate greater than 5% were entered as covariates and unstructured covariance matrix was used.|Odds Ratio (OR)|2.64|||<|0.001|TWO_SIDED|95.0|2.35|2.96|||Regression, Logistic||Odds ratio for Visit (3 months / baseline (reference)).|||2.96|2.35|< 0.001
72611242|NCT06119854|144751331|OTHER||Risk Difference (RD)|0.045|||||TWO_SIDED|95.0|-0.019|0.109|||||RD was calculated as the risk in the CBT arm minus the risk in the standard arm.|||0.109|-0.019|
72611243|NCT06119854|144751331|OTHER||Risk Ratio (RR)|1.323|||||TWO_SIDED|95.0|1.074|1.631|||||the inoculation arm is the numerator and the standard arm is the denominator.|||1.631|1.074|
72611244|NCT06119854|144751331|OTHER||Risk Difference (RD)|0.111|||||TWO_SIDED|95.0|0.045|0.176|||||RD was calculated as the risk in the inoculation arm minus the risk in the standard arm.|||0.176|0.045|
72418476|NCT04672941|144347306|OTHER|The logistic generalized estimating equations (GEE) model with usual activities as dependent variable. Visit, Chronic Obstructive Lung Disease (GOLD) group, smoking habits, pack years, sex, age, and comorbidities appearing at a rate greater than 5% were entered as covariates and unstructured covariance matrix was used.|Odds Ratio (OR)|4.46|||<|0.001|TWO_SIDED|95.0|3.89|5.12|||Regression, Logistic||Odds ratio for Visit (3 months / baseline (reference)).|||5.12|3.89|< 0.001
72418477|NCT04672941|144347307|OTHER|The logistic generalized estimating equations (GEE) model with pain/discomfort as dependent variable. Visit, Chronic Obstructive Lung Disease (GOLD) group, smoking habits, pack years, sex, age, and comorbidities appearing at a rate greater than 5% were entered as covariates and unstructured covariance matrix was used.|Odds Ratio (OR)|3.4|||<|0.001|TWO_SIDED|95.0|3.0|3.85|||Regression, Logistic||Odds ratio for Visit (3 months / baseline (reference)).|||3.85|3.00|< 0.001
72418478|NCT04672941|144347308|OTHER|The logistic generalized estimating equations (GEE) model with anxiety/depression as dependent variable. Visit, Chronic Obstructive Lung Disease (GOLD) group, smoking habits, pack years, sex, age, and comorbidities appearing at a rate greater than 5% were entered as covariates and unstructured covariance matrix was used.|Odds Ratio (OR)|3.32|||<|0.001|TWO_SIDED|95.0|2.95|3.73|||Regression, Logistic||Odds ratio for Visit (3 months / baseline (reference)).|||3.73|2.95|< 0.001
72418479|NCT04672941|144347314|OTHER|Mixed model for repeated measurements (MMRM) assuming random missingness was fitted. The dependent variable was the mMRC score. Visit, Global Initiative for Chronic Obstructive Lung Disease (GOLD) group, smoking habits, pack years, sex, age, and comorbidities appearing at a rate greater than 5% were entered as covariates.|Score on a scale|-0.55|||||TWO_SIDED|95.0|-0.6|-0.51|||||Least Square Mean for Visit, change from baseline (3 months - baseline) of mMRC based on non-responder imputation.|||-0.51|-0.60|
72418480|NCT00765388|144347327|SUPERIORITY_OR_OTHER|||||||0.96|||||||Regression, Logistic|An ordinal logistic regression model. The null hypothesis tested is that there is no difference in the multinomial distributions defined by products||||||0.96
72418481|NCT00765388|144347329|SUPERIORITY_OR_OTHER|||||||0.92|||||||Regression, Logistic|An ordinal logistic regression model. The null hypothesis tested is that there is no difference in the multinomial distributions defined by products||||||0.92
72418482|NCT00765388|144347331|SUPERIORITY_OR_OTHER|||||||0.4||0.0|||||Regression, Logistic|An ordinal logistic regression model. The null hypothesis tested is that there is no difference inthe multinomial distributions defined by products||||||0.40
72418483|NCT00765388|144347332|SUPERIORITY_OR_OTHER|||||||0.64|||||||Regression, Logistic|An ordinal logistic regression model. The null hypothesis tested is that there is no difference inthe multinomial distributions defined by products||||||0.64
72418484|NCT00765388|144347333|SUPERIORITY_OR_OTHER|||||||0.55|||||||Regression, Logistic|An ordinal logistic regression model. The null hypothesis tested is that there is no difference inthe multinomial distributions defined by products||||||0.55
72611245|NCT03104374|144751333|SUPERIORITY|The overall type I error rate of primary and ranked key secondary endpoints was strongly controlled using a graphical multiple testing procedure starting with the primary endpoint using α/2 for each dose followed by a prespecified α transfer path.|Response Rate Difference|32.8|||<|0.0001|TWO_SIDED|95.0|24.0|41.6|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted for the main stratification factor of current DMARD use (yes/no).|Response Rate Difference = Upadacitinib - Placebo|||41.6|24.0|<0.0001
72418485|NCT00765388|144347334|SUPERIORITY_OR_OTHER|||||||0.48|||||||Regression, Logistic|An ordinal logistic regression model. The null hypothesis tested is that there is no difference inthe multinomial distributions defined by products||||||0.48
72418486|NCT03923933|144347338|SUPERIORITY||||||<|0.001|||||||ANOVA|anova repeated measures||||||<0.001
72418487|NCT03923933|144347339|SUPERIORITY|||||||0.006|||||||ANOVA|Repeated Measures||||||0.006
72326398|NCT01047189|144176012|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||Kruskal-Wallis|||||||0.05
72418488|NCT03923933|144347340|SUPERIORITY|||||||0.371|||||||ANOVA|||||||0.371
72418489|NCT03923933|144347341|SUPERIORITY||||||<|0.001|||||||ANOVA|||||||<0.001
72418490|NCT03923933|144347343|SUPERIORITY|||||||0.028|||||||ANOVA|||||||0.028
72418491|NCT03923933|144347344|SUPERIORITY|||||||0.018|||||||ANOVA|||||||0.018
72418492|NCT00419263|144347345|SUPERIORITY_OR_OTHER|||||||0.377|TWO_SIDED||||||Regression, Cox|P-value is based on the treatment parameter from the Cox Regression Model including treatment, current smoking behavior, and geographic region.||||||0.377
72418493|NCT00419263|144347346|SUPERIORITY_OR_OTHER|||||||0.007|TWO_SIDED|||||P-value is based on the log-rank statistic controlling for current smoking behavior and geographic region.|Log Rank|||||||0.007
72418494|NCT00419263|144347347|SUPERIORITY_OR_OTHER|||||||0.537|TWO_SIDED|||||P-value is based on the log-rank statistic controlling for current smoking behavior and geographic region.|Log Rank|||||||0.537
72418495|NCT00419263|144347348|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED|||||The differences between the treatment groups were evaluated using a Wilcoxon Rank Sum Test controlling for current smoking behavior.|Wilcoxon (Mann-Whitney)|||||||0.002
72418496|NCT00419263|144347349|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||The differences between the treatment groups were evaluated using a Wilcoxon Rank Sum Test controlling for current smoking behavior.|Wilcoxon (Mann-Whitney)|||||||< 0.001
72418497|NCT00419263|144347350|SUPERIORITY_OR_OTHER|||||||0.409|TWO_SIDED|||||The differences between the treatment groups were evaluated using a Wilcoxon Rank Sum Test controlling for current smoking behavior.|Wilcoxon (Mann-Whitney)|||||||0.409
72418498|NCT00419263|144347351|SUPERIORITY_OR_OTHER|||||||0.327|TWO_SIDED|||||The differences between the treatment groups were evaluated using a Wilcoxon Rank Sum Test controlling for current smoking behavior.|Wilcoxon (Mann-Whitney)|||||||0.327
72418499|NCT01786967|144347359|SUPERIORITY|This was a pilot study to provide preliminary data to inform future sample size estimates for a larger more definitive trial|Risk Ratio (RR)|0.96||||1|TWO_SIDED|95.0|0.53|1.71|||Fisher Exact|||Null hypothesis was that there will be no difference in treatment benefit scale between the two groups||1.71|0.53|1.0
72418500|NCT01786967|144347360|SUPERIORITY||Risk Ratio (RR)|0.85||||1|TWO_SIDED|95.0|0.76|0.95|||Fisher Exact|||Null hypothesis was that there was no difference in the rate of moderate to severe adverse events.||.95|.76|1.0
72418501|NCT01563536|144347378|SUPERIORITY_OR_OTHER||Mean Difference (Maximal Decrease)|-1.5||||0.035|TWO_SIDED|95.0|-2.81|-0.13||Pre-specified 2-sided significance level of 0.05.|ANCOVA|Analysis of covariance (ANCOVA) with the baseline log10 HCV RNA values as a covariate and with an effect for treatment arm.||||-0.13|-2.81|0.035
72418502|NCT00538590|144347384|SUPERIORITY_OR_OTHER|||||||0.95||95.0|||||ANOVA|||Null hypothesis: post-operative intraocular pressure change in ologen group is equal to that in Mitomycin-C group.||||0.95
72418503|NCT00538590|144347386|SUPERIORITY_OR_OTHER|||||||1||95.0|||||ANOVA|||Null hypothesis: post-operative intraocular pressure change in ologen group is equal to that in Mitomycin-C group.||||1.00
72418504|NCT00538590|144347387|SUPERIORITY_OR_OTHER|||||||0.4||95.0|||||ANOVA|||Null hypothesis: post-operative intraocular pressure change in ologen group is equal to that in Mitomycin-C group.||||0.40
72418505|NCT00538590|144347388|SUPERIORITY_OR_OTHER|||||||0.91||95.0|||||ANOVA|||Null hypothesis: post-operative intraocular pressure change in ologen group is equal to that in Mitomycin-C group.||||0.91
72611246|NCT03104374|144751333|SUPERIORITY|The overall type I error rate of primary and ranked key secondary endpoints was strongly controlled using a graphical multiple testing procedure starting with the primary endpoint using α/2 for each dose followed by a prespecified α transfer path.|Response Rate Difference|39.7|||<|0.0001|TWO_SIDED|95.0|31.1|48.3|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted for the main stratification factor of current DMARD use (yes/no).|Response Rate Difference = Upadacitinib - Placebo|||48.3|31.1|<0.0001
72611247|NCT03104374|144751334|SUPERIORITY|The overall type I error rate of primary and ranked key secondary endpoints was strongly controlled using a graphical multiple testing procedure starting with the primary endpoint using α/2 for each dose followed by a prespecified α transfer path.|Least Squares (LS) Mean Difference|-0.21|||<|0.0001|TWO_SIDED|95.0|-0.3|-0.12|||Mixed Effect Model Repeated Measurement|MMRM analysis including treatment, visit, treatment-by-visit interaction, current DMARD use (yes/no) as fixed factors and Baseline value as covariate.|Treatment Difference = Upadacitinib - Placebo|||-0.12|-0.30|<0.0001
72611248|NCT03104374|144751334|SUPERIORITY|The overall type I error rate of primary and ranked key secondary endpoints was strongly controlled using a graphical multiple testing procedure starting with the primary endpoint using α/2 for each dose followed by a prespecified α transfer path.|LS Mean Difference|-0.31|||<|0.0001|TWO_SIDED|95.0|-0.4|-0.22|||Mixed Effect Model Repeated Measurement|MMRM analysis including treatment, visit, treatment-by-visit interaction, current DMARD use (yes/no) as fixed factors and Baseline value as covariate.|Treatment Difference = Upadacitinib - Placebo|||-0.22|-0.40|<0.0001
72418506|NCT05725317|144347391|NON_INFERIORITY|Noninferiority in distance visual acuity was declared if the upper confidence limit was less than 0.05.|LS Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.004|||ONE_SIDED|95.0||0.0||Since a noninferiority hypothesis is being tested, a p-value is not applicable. Confidence limit is being reported and compared to the noninferiority margin.|||LSM results based on mixed effects repeated measures model with both fixed (lens, visit, lens-by-visit interaction and sequence) and random (subject) effects. Difference = LID220365 minus LID006961. Sign is retained with the rounded value.|||0.00||
72418507|NCT02460692|144347393|SUPERIORITY|||||||0.78||||||The average pain change at the treatment period (weeks 5-8) from baseline were compared between the two arms using an unstructured covariance model, excluding main group effect.|unstructured covariance model|||This is the primary comparison.||||0.78
72418508|NCT02460692|144347393|SUPERIORITY|||||||0.07||||||The average pain change at the treatment period (weeks 5-8) from baseline were compared between the two arms using an unstructured covariance model, excluding main group effect.|Unstructured covariance model|||This is the secondary comparison.||||0.070
72418509|NCT02460692|144347393|SUPERIORITY|||||||0.044||||||The average pain change at the treatment period (weeks 5-8) from baseline were compared between the two arms using an unstructured covariance model, excluding main group effect.|Unstructured covariance model|||This is an exploratory comparison||||0.044
72418510|NCT02460692|144347394|SUPERIORITY|||||||0.27||||||The average change of impact scores at the treatment period (weeks 5-8) from baseline were compared between the two arms using an unstructured covariance model, excluding main group effect|unstructured covariance model|||||||0.27
72418511|NCT02460692|144347394|SUPERIORITY|||||||0.96||||||The average change of impact scores at the treatment period (weeks 5-8) from baseline were compared between the arms using an unstructured covariance model, excluding main group effect.|unstructured covariance model|||||||0.96
72418512|NCT02460692|144347394|SUPERIORITY|||||||0.3||||||The average change of impact scores at the treatment period (weeks 5-8) from baseline were compared between the two arms using an unstructured covariance model, excluding main group effect|unstructured covariance model|||||||0.30
72418513|NCT02460692|144347395|SUPERIORITY|||||||0.44||||||The average NPS change at the treatment period (weeks 5-8) from baseline were compared between the two arms using an unstructured covariance model, excluding main group effect|unstructured covariance model|||||||0.44
72418514|NCT02460692|144347395|SUPERIORITY|||||||0.53||||||The average pain change at the treatment period (weeks 5-8) from baseline were compared between the two arms using an unstructured covariance model, excluding main group effect|Unstructured covariance model|||||||0.53
72418515|NCT02460692|144347395|SUPERIORITY|||||||0.18||||||The average NPS change at the treatment period (weeks 5-8) from baseline were compared between the two arms using an unstructured covariance model, excluding main group effect|Unstructured covariance model|||||||0.18
72418516|NCT02460692|144347396|SUPERIORITY|||||||0.95||||||The average change of learning scores at the treatment period (weeks 5-8) from baseline were compared between the arms using an unstructured covariance model, excluding main group effect|unstructured covariance model|||||||0.95
72418517|NCT02460692|144347396|SUPERIORITY|||||||0.94||||||The average change of learning scores at the treatment period (weeks 5-8) from baseline were compared between the arms using an unstructured covariance model, excluding main group effect|unstructured covariance model|||||||0.94
72418518|NCT02460692|144347396|SUPERIORITY|||||||0.9||||||The average change of learning score at the treatment period (weeks 5-8) from baseline were compared between the arms using an unstructured covariance model, excluding main group effect|unstructured covariance model|||||||.90
72418519|NCT02460692|144347397|SUPERIORITY|||||||0.93||||||The average change of total time completing task in grooved pegboard test on dominant hand (weeks 5-8 at the treatment period) from baseline were compared between the two arms using an unstructured covariance model|unstructured covariance model|||||||0.93
72611249|NCT03104374|144751335|SUPERIORITY|The overall type I error rate of primary and ranked key secondary endpoints was strongly controlled using a graphical multiple testing procedure starting with the primary endpoint using α/2 for each dose followed by a prespecified α transfer path.|Response Rate Difference|27.6|||<|0.0001|TWO_SIDED|95.0|19.2|36.1|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted for the main stratification factor of current DMARD use (yes/no).|Response Rate Difference = Upadacitinib - Placebo|||36.1|19.2|<0.0001
72418520|NCT02460692|144347397|SUPERIORITY|||||||0.92||||||The average change of total time completing task in grooved pegboard test on dominant hand (weeks 5-8, at the treatment period) from baseline were compared between the two arms using an unstructured covariance model|unstructured covariance model|||||||0.92
72418521|NCT02460692|144347397|SUPERIORITY|||||||0.85||||||The average change of total time completing task in grooved pegboard test on dominant hand (weeks 5-8, at the treatment period) from baseline were compared between the two arms using an unstructured covariance model|unstructured covariance model|||||||0.85
72418522|NCT02460692|144347398|SUPERIORITY|||||||0.89||||||The average change in Wechsler Adult Intelligence Scale (WAIS)-III test score (weeks 5-8, at the treatment period) from baseline were compared between the two arms using an unstructured covariance model.|Unstructured covariance model|||||||0.89
72418523|NCT02460692|144347398|SUPERIORITY|||||||0.13||||||The average change in WAIS-III test score (weeks 5-8, at the treatment period) from baseline were compared between the two arms using an unstructured covariance model|unstructured covariance model|||||||0.13
72418524|NCT02460692|144347398|SUPERIORITY|||||||0.14||||||The average change in WAIS-III test score (weeks 5-8, at the treatment period) from baseline were compared between the two arms using an unstructured covariance model|unstructured covariance model|||||||0.14
72611250|NCT03104374|144751335|SUPERIORITY|The overall type I error rate of primary and ranked key secondary endpoints was strongly controlled using a graphical multiple testing procedure starting with the primary endpoint using α/2 for each dose followed by a prespecified α transfer path.|Response Rate Difference|31.0|||<|0.0001|TWO_SIDED|95.0|22.3|39.8|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted for the main stratification factor of current DMARD use (yes/no).|Response Rate Difference = Upadacitinib - Placebo|||39.8|22.3|<0.0001
72326399|NCT00052910|144176013|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|0.99|||||TWO_SIDED|95.0|0.79|1.24|||||Adjusted Hazard Ratio, ECF vs 5-FU/LV|||1.24|0.79|
72418525|NCT02460692|144347399|SUPERIORITY|||||||0.1||||||The average change of total mood disturbance scores (weeks 5-8, at the treatment period) from baseline were compared between the two arms using an unstructured covariance model, excluding main group effect.|Unstructured covariance model|||||||0.10
72418526|NCT02460692|144347399|SUPERIORITY|||||||0.67||||||The average change of total mood disturbance scores (weeks 5-8, at the treatment period) from baseline were compared between the two arms using an unstructured covariance model, excluding main group effect.|unstructured covariance model|||||||0.67
72418527|NCT02460692|144347399|SUPERIORITY|||||||0.25||||||The average change of total mood disturbance scores (weeks 5-8, at the treatment period) from baseline were compared between the two arms using an unstructured covariance model, excluding main group effect.|unstructured covariance model|||||||0.25
72418528|NCT02460692|144347400|SUPERIORITY|||||||0.84||||||The average change of beck score (weeks 5-8 at the treatment period) from baseline were compared between the arms using an unstructured covariance model, excluding main group effect|unstructured covariance model|||||||0.84
72418529|NCT02460692|144347400|SUPERIORITY|||||||0.91||||||The average change of beck score (weeks 5-8 at the treatment period) from baseline were compared between the arms using an unstructured covariance model, excluding main group effect|unstructured covariance model|||||||0.91
72418530|NCT02460692|144347400|SUPERIORITY|||||||0.75||||||The average change of beck score (weeks 5-8 at the treatment period) from baseline were compared between the arms using an unstructured covariance model, excluding main group effect|unstructured covariance model|||||||0.75
72418531|NCT02460692|144347401|SUPERIORITY|||||||0.24||||||Area under the time concentration curve (AUC) was calculated as the aggregate effect of response and compared between the arms.|Regression, Linear|||||||0.24
72418532|NCT02460692|144347401|SUPERIORITY|||||||0.08||||||Area under the time concentration curve (AUC) was calculated as the aggregate effect of response and compared between the arms.|Regression, Linear|||||||0.080
72418533|NCT02460692|144347401|SUPERIORITY|||||||0.005||||||Area under the time concentration curve (AUC) was calculated as the aggregate effect of response and compared between the arms.|Regression, Linear|||||||0.005
72418534|NCT02460692|144347402|SUPERIORITY|||||||0.6|||||||unstructured covariance model|||||||0.60
72418535|NCT02460692|144347402|SUPERIORITY|||||||0.4|||||||unstructured covariance model|||||||0.40
72418536|NCT02460692|144347402|SUPERIORITY|||||||0.72|||||||unstructured covariance model|||||||0.72
72418537|NCT02460692|144347403|SUPERIORITY|||||||0.19||||||The average change of pain sensitivity (weeks 5-8 at the treatment period) from baseline were compared between the arms using an unstructured covariance model.|unstructured covariance model|||||||0.19
72418538|NCT02460692|144347403|SUPERIORITY|||||||0.7||||||The average change of pain sensitivity (weeks 5-8 at the treatment period) from baseline were compared between the arms using an unstructured covariance model.|unstructured covariance model|||||||0.70
72418539|NCT02460692|144347403|SUPERIORITY|||||||0.36||||||The average change of pain sensitivity (weeks 5-8 at the treatment period) from baseline were compared between the arms using an unstructured covariance model|unstructured covariance model|||||||0.36
72418540|NCT02460692|144347404|SUPERIORITY|||||||0.14|||||||Regression, Linear|||Change in withdrawal intensity from week 8 to week 10 was compared between the two arms.||||.14
72611251|NCT03104374|144751336|SUPERIORITY|The overall type I error rate of primary and ranked key secondary endpoints was strongly controlled using a graphical multiple testing procedure starting with the primary endpoint using α/2 for each dose followed by a prespecified α transfer path.|Response Rate Difference|36.3|||<|0.0001|TWO_SIDED|95.0|25.6|46.9|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted for the main stratification factor of current DMARD use (yes/no).|Response Rate Difference = Upadacitinib - Placebo|||46.9|25.6|<0.0001
72418541|NCT02460692|144347404|SUPERIORITY|||||||0.6|||||||Regression, Linear|||Change in withdrawal intensity from week 8 to week 10 was compared between the two arms.||||.60
72418542|NCT02460692|144347404|SUPERIORITY|||||||0.34|||||||Regression, Linear|||Change in withdrawal intensity from week 8 to week 10 was compared between the two arms.||||.34
72418543|NCT02460692|144347405|SUPERIORITY|||||||0.34|||||||unstructured covariance model|||||||0.34
72418544|NCT02460692|144347405|SUPERIORITY|||||||0.007|||||||unstructured covariance model|||||||0.007
72611252|NCT03104374|144751336|SUPERIORITY|The overall type I error rate of primary and ranked key secondary endpoints was strongly controlled using a graphical multiple testing procedure starting with the primary endpoint using α/2 for each dose followed by a prespecified α transfer path.|Response Rate Difference|40.5|||<|0.0001|TWO_SIDED|95.0|29.9|51.0|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted for the main stratification factor of current DMARD use (yes/no).|Response Rate Difference = Upadacitinib - Placebo|||51.0|29.9|<0.0001
72418545|NCT02460692|144347405|SUPERIORITY|||||||0.055|||||||unstructured covariance model|||||||0.055
72418546|NCT02460692|144347406|SUPERIORITY|||||||0.69|||||||unstructured covariance model|||||||0.69
72418547|NCT02460692|144347406|SUPERIORITY|||||||0.79|||||||unstructured covariance model|||||||0.79
72418548|NCT02460692|144347406|SUPERIORITY|||||||0.97|||||||unstructured covariance model|||||||0.97
72418549|NCT02460692|144347407|SUPERIORITY|||||||0.21||||||Area under the time concentration curve (AUC) was calculated as the aggregate effect of response and compared between the arms.|Regression, Linear|||||||0.21
72418550|NCT02460692|144347407|SUPERIORITY|||||||0.029||||||Area under the time concentration curve (AUC) was calculated as the aggregate effect of response and compared between the arms.|Regression, Linear|||||||0.029
72418551|NCT02460692|144347407|SUPERIORITY|||||||0.001||||||Area under the time concentration curve (AUC) was calculated as the aggregate effect of response and compared between the arms.|Regression, Linear|||||||0.001
72418552|NCT02460692|144347408|SUPERIORITY|||||||0.084|||||||Regression, Linear|||Change in negative impact of withdrawal from week 8 to week 10 was compared between the two arms.||||0.084
72418553|NCT02460692|144347408|SUPERIORITY|||||||0.98|||||||Regression, Linear|||Change in negative impact of withdrawal from week 8 to week 10 was compared between the two arms.||||0.98
72418554|NCT02460692|144347408|SUPERIORITY|||||||0.085|||||||Regression, Linear|||Change in negative impact of withdrawal from week 8 to week 10 was compared between the two arms.||||0.085
72418555|NCT02460692|144347409|SUPERIORITY|||||||0.95||||||The average change of pain tolerance (weeks 5-8 at the treatment period) from baseline were compared between the arms using an unstructured covariance model|unstructured covariance model|||||||0.95
72418556|NCT02460692|144347409|SUPERIORITY|||||||0.78||||||The average change of pain tolerance (weeks 5-8 at the treatment period) from baseline were compared between the arms using an unstructured covariance model.|unstructured covariance model|||||||0.78
72418557|NCT02460692|144347409|SUPERIORITY|||||||0.99||||||The average change of pain tolerance (weeks 5-8 at the treatment period) from baseline were compared between the arms using an unstructured covariance model.|unstructured covariance model|||||||0.99
72418558|NCT02276222|144347458|SUPERIORITY||Least Squares Mean (SE)|0.0084|STANDARD_ERROR_OF_MEAN|0.01012||0.4041|TWO_SIDED|95.0|-0.0114|0.0283|||ANCOVA|||||0.0283|-0.0114|0.4041
72418559|NCT01971723|144347459|SUPERIORITY_OR_OTHER|||||||0.38|TWO_SIDED||||||ANOVA|Groups were compared against each other at the two different time points and against themselves at the same time points.||This statistical analysis is for the squat one repetition maximum outcomes, only.||||.38
72418560|NCT01971723|144347459|SUPERIORITY_OR_OTHER|||||||0.0001|TWO_SIDED||||||ANOVA|||This statistical analysis is for the bench press one repetition maximum outcomes, only.||||0.0001
72418561|NCT01971723|144347459|SUPERIORITY_OR_OTHER|||||||0.3|TWO_SIDED||||||ANOVA|||This statistical analysis is for the deadlift one repetition maximum measures, only.||||.3
72418562|NCT01971723|144347459|SUPERIORITY_OR_OTHER|||||||0.0001|TWO_SIDED||||||ANOVA|||This statistical analysis compares the outcomes of the total weight lifted.||||0.0001
72418563|NCT01971723|144347460|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||ANOVA|||||||>.05
72418564|NCT01971723|144347461|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||ANOVA|||This statistical measurement is for cholesterol measure outcomes, only.||||>.05
72418565|NCT01971723|144347461|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||ANOVA|||This statistical analysis is for glucose measure outcomes, only.||||>.05
72418566|NCT01971723|144347461|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||ANOVA|||This statistical analysis is for HDL measure outcomes, only.||||>.05
72418567|NCT01971723|144347461|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||ANOVA|||This statistical analysis is for LDL measure outcomes, only.||||>.05
72418568|NCT01971723|144347461|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||ANOVA|||This statistical analysis for the triglyceride measure outcomes, only.||||>.05
72418569|NCT01971723|144347462|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||ANOVA|||||||>.05
72611253|NCT03104374|144751337|SUPERIORITY|The overall type I error rate of primary and ranked key secondary endpoints was strongly controlled using a graphical multiple testing procedure starting with the primary endpoint using α/2 for each dose followed by a prespecified α transfer path.|LS Mean Difference|3.52|||<|0.0001|TWO_SIDED|95.0|2.07|4.98|||Mixed Effect Model Repeated Measurement|MMRM analysis including treatment, visit, treatment-by-visit interaction, current DMARD use (yes/no) as fixed factors and Baseline value as covariate.|Treatment Difference = Upadacitinib - Placebo|||4.98|2.07|<0.0001
72418570|NCT01971723|144347463|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||ANOVA|||||||>.05
72418571|NCT01971723|144347464|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||ANOVA|||||||>.05
72418572|NCT01971723|144347465|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||ANOVA|||||||>.05
72418573|NCT01971723|144347466|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||ANOVA|||||||>.05
72418574|NCT01971723|144347467|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Chi-squared|||||||>.05
72418575|NCT01971723|144347468|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||t-test, 2 sided|||This statistical analysis is for deadlift volume measure outcomes, only.||||>.05
72326400|NCT00052910|144176014|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|1.03|||||TWO_SIDED|95.0|0.83|1.28|||||Adjusted Hazard Ratio, ECF vs 5-FU/LV|||1.28|0.83|
72326401|NCT01187095|144176015|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Estimation parameter|||||<|0.05|||||||Mixed Models Analysis|||||||<0.05
72326402|NCT01187095|144176015|SUPERIORITY||||||<|0.05|||||||Regression, Logistic|||||||<0.05
72418576|NCT01971723|144347468|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||t-test, 2 sided|||This statistical analysis is for auxiliary squat volume measure outcomes, only.||||>.05
72418577|NCT01971723|144347468|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||ANOVA|||This statistical analysis is for squat volume measure outcomes, only.||||>.05
72418578|NCT01971723|144347468|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||t-test, 2 sided|||This statistical analysis is for bench volume measure outcomes, only.||||>.05
72418579|NCT01971723|144347468|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||t-test, 2 sided|||This statistical analysis is for total squat volume measures, only.||||>.05
72418580|NCT01971723|144347468|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||t-test, 2 sided|||This statistical analysis is for total weight lifted volume measure outcomes, only.||||>.05
72418581|NCT01971723|144347469|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||ANOVA|||||||>.05
72418582|NCT01971723|144347470|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||ANOVA|||||||>.05
72418583|NCT01971723|144347471|SUPERIORITY_OR_OTHER|||||||0.05|TWO_SIDED||||||ANOVA|||||||.05
72418584|NCT05899686|144347472|EQUIVALENCE|Equivalence was defined as ANOVA p\<0.05||||||0.65|||||||ANOVA|||Maximum percent change from baseline (light transmittance) during 60 heart beats after the tetanic stimulus were compared between the three stimulus locations using ANOVA||||0.65
72418585|NCT00902694|144347479|SUPERIORITY||Mean Difference (Net)|-1.5|||||TWO_SIDED|95.0|-2.6|-0.4||||||6 month intervention versus control||-0.4|-2.6|
72418586|NCT00902694|144347479|SUPERIORITY||Mean Difference (Net)|-3.2|||||TWO_SIDED|95.0|-5.1|-1.2||||||18 month intervention versus control||-1.2|-5.1|
72418587|NCT00902694|144347481|SUPERIORITY||Mean Difference (Net)|-2.0|||||TWO_SIDED|95.0|-3.6|-0.4||||||6 month intervention versus control||-0.4|-3.6|
72418588|NCT00902694|144347481|SUPERIORITY||Mean Difference (Net)|-1.9|||||TWO_SIDED|95.0|-4.1|0.3||||||18 month intervention versus control||0.3|-4.1|
72418589|NCT00902694|144347482|SUPERIORITY||Mean Difference (Net)|-0.4|||||TWO_SIDED|95.0|-3.2|2.4||||||6 month systolic intervention versus control||2.4|-3.2|
72418590|NCT00902694|144347482|SUPERIORITY||Mean Difference (Net)|0.2|||||TWO_SIDED|95.0|-1.6|2.1||||||6 month diastolic intervention versus control||2.1|-1.6|
72418591|NCT00902694|144347482|SUPERIORITY||Mean Difference (Net)|1.6|||||TWO_SIDED|95.0|-1.6|4.8||||||18 month systolic intervention versus control||4.8|-1.6|
72418592|NCT00902694|144347482|SUPERIORITY||Mean Difference (Net)|1.2|||||TWO_SIDED|95.0|-0.9|3.4||||||18 month diastolic intervention versus control||3.4|-0.9|
72418593|NCT00902694|144347483|SUPERIORITY||Mean Difference (Net)|-2.9|||||TWO_SIDED|95.0|-9.9|4.1||||||6 month total chol intervention versus control||4.1|-9.9|
72418594|NCT00902694|144347483|SUPERIORITY||Mean Difference (Net)|-5.2|||||TWO_SIDED|95.0|-14.9|4.4||||||18 month total chol intervention versus control||4.4|-14.9|
72418595|NCT00902694|144347483|SUPERIORITY||Mean Difference (Net)|-1.2|||||TWO_SIDED|95.0|-7.5|5.1||||||6 month LDL chol intervention versus control||5.1|-7.5|
72418596|NCT00902694|144347483|SUPERIORITY||Mean Difference (Net)|-4.6|||||TWO_SIDED|95.0|-13.1|3.9||||||18 month LDL chol intervention versus control||3.9|-13.1|
72418597|NCT00902694|144347483|SUPERIORITY||Mean Difference (Net)|-0.6|||||TWO_SIDED|95.0|-2.9|1.7||||||6 month HDL chol intervention versus control||1.7|-2.9|
72418598|NCT00902694|144347483|SUPERIORITY||Mean Difference (Net)|0.6|||||TWO_SIDED|95.0|-1.8|3.1||||||18 month HDL intervention versus control||3.1|-1.8|
72418599|NCT00902694|144347483|SUPERIORITY||Mean Difference (Net)|-5.5|||||TWO_SIDED|95.0|-23.5|12.4||||||6 month TRIG intervention versus control||12.4|-23.5|
72611254|NCT03104374|144751337|SUPERIORITY|The overall type I error rate of primary and ranked key secondary endpoints was strongly controlled using a graphical multiple testing procedure starting with the primary endpoint using α/2 for each dose followed by a prespecified α transfer path.|LS Mean Difference|5.44|||<|0.0001|TWO_SIDED|95.0|3.99|6.88|||Mixed Effect Model Repeated Measurement|MMRM analysis including treatment, visit, treatment-by-visit interaction, current DMARD use (yes/no) as fixed factors and Baseline value as covariate.|Treatment Difference = Upadacitinib - Placebo|||6.88|3.99|<0.0001
72611255|NCT03104374|144751338|SUPERIORITY|The overall type I error rate of primary and ranked key secondary endpoints was strongly controlled using a graphical multiple testing procedure starting with the primary endpoint using α/2 for each dose followed by a prespecified α transfer path.|LS Mean Difference|3.7|||<|0.0001|TWO_SIDED|95.0|2.0|5.4|||Mixed Effect Model Repeated Measurement|MMRM analysis including treatment, visit, treatment-by-visit interaction, current DMARD use (yes/no) as fixed factors and Baseline value as covariate.|Treatment Difference = Upadacitinib - Placebo|||5.4|2.0|<0.0001
72611256|NCT03104374|144751338|SUPERIORITY||LS Mean Difference|4.8|||<|0.0001|TWO_SIDED|95.0|3.1|6.4|||Mixed Effect Model Repeated Measurement|MMRM analysis including treatment, visit, treatment-by-visit interaction, current DMARD use (yes/no) as fixed factors and Baseline value as covariate.|Treatment Difference = Upadacitinib - Placebo|The overall type I error rate of primary and ranked key secondary endpoints was strongly controlled using a graphical multiple testing procedure starting with the primary endpoint using α/2 for each dose followed by a prespecified α transfer path.||6.4|3.1|<0.0001
72611257|NCT03104374|144751339|SUPERIORITY|The overall type I error rate of primary and ranked key secondary endpoints was strongly controlled using a graphical multiple testing procedure starting with the primary endpoint using α/2 for each dose followed by a prespecified α transfer path.|Response Rate Difference|22.3|||<|0.0001|TWO_SIDED|95.0|16.0|28.6|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted for the main stratification factor of current DMARD use (yes/no).|Response Rate Difference = Upadacitinib - Placebo|||28.6|16.0|<0.0001
72611258|NCT03104374|144751339|SUPERIORITY|The overall type I error rate of primary and ranked key secondary endpoints was strongly controlled using a graphical multiple testing procedure starting with the primary endpoint using α/2 for each dose followed by a prespecified α transfer path.|Response Rate Difference|26.1|||<|0.0001|TWO_SIDED|95.0|19.7|32.5|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted for the main stratification factor of current DMARD use (yes/no).|Response Rate Difference = Upadacitinib - Placebo|||32.5|19.7|<0.0001
72611259|NCT03104374|144751340|SUPERIORITY|The overall type I error rate of primary and ranked key secondary endpoints was strongly controlled using a graphical multiple testing procedure starting with the primary endpoint using α/2 for each dose followed by a prespecified α transfer path.|LS Mean Difference|-22.9|||<|0.0001|TWO_SIDED|95.0|-27.4|-18.4|||Mixed Effect Model Repeated Measurement|MMRM analysis including treatment, visit, treatment-by-visit interaction, current DMARD use (yes/no) as fixed factors and Baseline value as covariate.|Treatment Difference = Upadacitinib - Placebo|||-18.4|-27.4|<0.0001
72611260|NCT03104374|144751340|SUPERIORITY|The overall type I error rate of primary and ranked key secondary endpoints was strongly controlled using a graphical multiple testing procedure starting with the primary endpoint using α/2 for each dose followed by a prespecified α transfer path.|LS Mean Difference|-28.2|||<|0.0001|TWO_SIDED|95.0|-32.7|-23.8|||Mixed Effect Model Repeated Measurement|MMRM analysis including treatment, visit, treatment-by-visit interaction, current DMARD use (yes/no) as fixed factors and Baseline value as covariate.|Treatment Difference = Upadacitinib - Placebo|||-23.8|-32.7|<0.0001
72611261|NCT03104374|144751341|SUPERIORITY||Response Rate Difference|27.0|||<|0.0001|TWO_SIDED|95.0|20.1|33.9|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted for the main stratification factor of current DMARD use (yes/no).|Response Rate Difference = Upadacitinib - Placebo|||33.9|20.1|<0.0001
72611262|NCT03104374|144751341|SUPERIORITY||Response Rate Difference|32.9|||<|0.0001|TWO_SIDED|95.0|25.9|39.9|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted for the main stratification factor of current DMARD use (yes/no).|Response Rate Difference = Upadacitinib - Placebo|||39.9|25.9|<0.0001
72611263|NCT03104374|144751342|SUPERIORITY||Response Rate Difference|8.1|||<|0.0001|TWO_SIDED|95.0|4.2|11.9|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted for the main stratification factor of current DMARD use (yes/no).|Response Rate Difference = Upadacitinib - Placebo|||11.9|4.2|<0.0001
72611264|NCT03104374|144751342|SUPERIORITY||Response Rate Difference|16.0|||<|0.0001|TWO_SIDED|95.0|11.0|21.1|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted for the main stratification factor of current DMARD use (yes/no).|Response Rate Difference = Upadacitinib - Placebo|||21.1|11.0|<0.0001
72611265|NCT03104374|144751343|SUPERIORITY||Response Rate Difference|21.9|||<|0.0001|TWO_SIDED|95.0|14.3|29.4|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusting for the main stratification factor of current DMARD use (yes/no).|Response Rate Difference = Upadacitinib - Placebo|||29.4|14.3|<0.0001
72611266|NCT03104374|144751343|SUPERIORITY||Response Rate Difference|22.6|||<|0.0001|TWO_SIDED|95.0|15.1|30.2|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted for the main stratification factor of current DMARD use (yes/no).|Response Rate Difference = Upadacitinib - Placebo|||30.2|15.1|<0.0001
72418600|NCT00902694|144347483|SUPERIORITY||Mean Difference (Net)|-1.5|||||TWO_SIDED|95.0|-27.0|23.9||||||18 month TRIG intervention versus control||23.9|-27.0|
72418601|NCT04450108|144347494|SUPERIORITY|The change of FeNO values will be estimated in ANCOVA with baseline values as the covariable and will be reported as percent change together with the 95%-confidence interval.|||||<|0.001|||||||ANCOVA|||Since the effect size of the change (mean change / standard deviation) is on the order of 1 (resulting in N=10 and 13 for power = 80% and 90%, respectively) and therefore large, the sample size is not determined by the primary objective but by the necessity to achieve representative data of FeNO measurement data over all age groups, measurement ranges (\<, ≥ cut off) and sites. Thus, 120 subjects will be recruited.||||<0.001
72418602|NCT01024608|144347500|SUPERIORITY_OR_OTHER_LEGACY||LS mean treatment diff from placebo|-0.91|||<|0.001|TWO_SIDED|95.0|-1.3|-0.5||A priori threshold for statistical significance is p\<0.05.|ANCOVA|Repeated measures ANCOVA included covariate adjustment for baseline, day, treatment, and the treatment by day interaction.||||-0.5|-1.3|<0.001
72418603|NCT01024608|144347501|SUPERIORITY_OR_OTHER_LEGACY||LS mean treatment diff from placebo|-0.92|||<|0.001|TWO_SIDED|95.0|-1.3|-0.5||A priori threshold for statistical significance is p\<0.05|ANCOVA|The repeated measures ANCOVA included covariate adjustment for baseline, day, treatment, and the treatment by day interaction.||||-0.5|-1.3|<0.001
72418604|NCT01024608|144347502|SUPERIORITY_OR_OTHER_LEGACY||LS mean treatment diff from placebo|-0.48||||0.005|TWO_SIDED|95.0|-0.8|-0.1||A priori threshold for statistical significance is p\<0.05|ANCOVA|Results obtained from ANCOVA with treatment, baseline and center in the model.||||-0.1|-0.8|0.005
72418605|NCT01024608|144347503|SUPERIORITY_OR_OTHER_LEGACY||LS mean treatment diff from placebo|-0.56||||0.002|TWO_SIDED|95.0|-0.9|-0.2||A priori threshold for statistical significance is p\<0.05|ANCOVA|The repeated measures ANCOVA included covariate adjustment for baseline, day, treatment, and the treatment by day interaction||||-0.2|-0.9|0.002
72418606|NCT04922554|144347544|OTHER|Endpoints are summarized using descriptive statistics. Inferential testing of pre-specified hypothesis was not completed.|Difference in response rates|14.15||||0.2182|TWO_SIDED|||||Nominal p-values are provided for descriptive purposes.|Chi-squared|Analysis stratified by prior NTM antibiotic treatment was not performed due to small sample size in one randomization stratification subgroup.||||||0.2182
72418607|NCT04922554|144347545|OTHER|Endpoints are summarized using descriptive statistics. Inferential testing of pre-specified hypothesis was not completed.|Difference in response rates|22.15||||0.046|TWO_SIDED|||||Nominal p-values are provided for descriptive purposes.|Chi-squared|Analysis stratified by prior NTM antibiotic treatment was not performed due to small sample size in one randomization stratification subgroup.||||||0.0460
72418608|NCT04922554|144347554|OTHER|Endpoints are summarized using descriptive statistics. Inferential testing of pre-specified hypothesis was not completed.|Least square mean difference|0.8||||0.824|TWO_SIDED|95.0|-6.01|7.52||ANCOVA analyzed change from baseline using treatment, prior antibiotic use, and baseline score as factors. LS mean difference = Omadacycline minus Placebo.|ANCOVA|||||7.52|-6.01|0.8240
72418609|NCT04922554|144347555|OTHER|Endpoints are summarized using descriptive statistics. Inferential testing of pre-specified hypothesis was not completed.|Least square mean difference|5.1||||0.2149|TWO_SIDED|95.0|-3.03|13.2||ANCOVA analyzed change from baseline using treatment, prior antibiotic use, and baseline score as factors. LS mean difference = Omadacycline minus Placebo.|ANCOVA|||||13.20|-3.03|0.2149
72418610|NCT04922554|144347556|OTHER|Endpoints are summarized using descriptive statistics. Inferential testing of pre-specified hypothesis was not completed.|Least square mean difference|8.3||||0.123|TWO_SIDED|95.0|-2.31|18.88||ANCOVA analyzed change from baseline using treatment, prior antibiotic use, and baseline score as factors. LS mean difference = Omadacycline minus Placebo.|ANCOVA|||||18.88|-2.31|0.1230
72418611|NCT04922554|144347557|OTHER|Endpoints are summarized using descriptive statistics. Inferential testing of pre-specified hypothesis was not completed.|Least square mean difference|5.5||||0.1168|TWO_SIDED|95.0|-1.41|12.43||ANCOVA analyzed change from baseline using treatment, prior antibiotic use, and baseline score as factors. LS mean difference = Omadacycline minus Placebo.|ANCOVA|||||12.43|-1.41|0.1168
72418612|NCT04922554|144347558|OTHER|Endpoints are summarized using descriptive statistics. Inferential testing of pre-specified hypothesis was not completed.|Least square mean difference|6.5||||0.0743|TWO_SIDED|95.0|-0.66|13.66||ANCOVA analyzed change from baseline using treatment, prior antibiotic use, and baseline score as factors. LS mean difference = Omadacycline minus Placebo.|ANCOVA|||||13.66|-0.66|0.0743
72418613|NCT04922554|144347559|OTHER|Endpoints are summarized using descriptive statistics. Inferential testing of pre-specified hypothesis was not completed.|Least square mean difference|7.1||||0.0899|TWO_SIDED|95.0|-1.13|15.23||ANCOVA analyzed change from baseline using treatment, prior antibiotic use, and baseline score as factors. LS mean difference = Omadacycline minus Placebo.|ANCOVA|||||15.23|-1.13|0.0899
72418614|NCT04922554|144347560|OTHER|Endpoints are summarized using descriptive statistics. Inferential testing of pre-specified hypothesis was not completed.|Least square mean difference|0.5||||0.9019|TWO_SIDED|95.0|-7.6|8.59||ANCOVA analyzed change from baseline using treatment, prior antibiotic use, and baseline score as factors. LS mean difference = Omadacycline minus Placebo.|ANCOVA|||||8.59|-7.60|0.9019
72418615|NCT04922554|144347561|OTHER|Endpoints are summarized using descriptive statistics. Inferential testing of pre-specified hypothesis was not completed.|Least square mean difference|13.7||||0.0015|TWO_SIDED|95.0|5.43|21.89||ANCOVA analyzed change from baseline using treatment, prior antibiotic use, and baseline score as factors. LS mean difference = Omadacycline minus Placebo.|ANCOVA|||||21.89|5.43|0.0015
72326403|NCT01475721|144176025|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority comparison is statistically significant if the upper bound of the two-sided 95% CI falls below 2, the non-inferiority margin, and the non-inferiority test one-sided p-value \<0.025.|Hazard Ratio (HR)|1.029||||0.003|TWO_SIDED|95.0|0.638|1.662|||Regression, Cox|||||1.662|0.638|0.003
72418616|NCT04922554|144347562|OTHER|Endpoints are summarized using descriptive statistics. Inferential testing of pre-specified hypothesis was not completed.|Least square mean difference|0.9||||0.8269|TWO_SIDED|95.0|-7.26|9.05||ANCOVA analyzed change from baseline using treatment, prior antibiotic use, and baseline score as factors. LS mean difference = Omadacycline minus Placebo.|ANCOVA||Treatment comparison of Omadacycline and Placebo for activity score has been presented.|||9.05|-7.26|0.8269
72418617|NCT04922554|144347562|OTHER|Endpoints are summarized using descriptive statistics. Inferential testing of pre-specified hypothesis was not completed.|Least square mean difference|-0.2||||0.9584|TWO_SIDED|95.0|-7.74|7.35||ANCOVA analyzed change from baseline using treatment, prior antibiotic use, and baseline score as factors. LS mean difference = Omadacycline minus Placebo.|ANCOVA||Treatment comparison between Omadacycline and Placebo for impact score has been presented|||7.35|-7.74|0.9584
72418618|NCT04922554|144347562|OTHER|Endpoints are summarized using descriptive statistics. Inferential testing of pre-specified hypothesis was not completed.|Least square mean difference|-5.0||||0.2123|TWO_SIDED|95.0|-12.88|2.92||ANCOVA analyzed change from baseline using treatment, prior antibiotic use, and baseline score as factors. LS mean difference = Omadacycline minus Placebo.|ANCOVA||Treatment comparison between Omadacycline and Placebo for symptom score has been presented.|||2.92|-12.88|0.2123
72418619|NCT04922554|144347562|OTHER|Endpoints are summarized using descriptive statistics. Inferential testing of pre-specified hypothesis was not completed.|Least square mean difference|-0.8||||0.8161|TWO_SIDED|95.0|-7.58|5.99||ANCOVA analyzed change from baseline using treatment, prior antibiotic use, and baseline score as factors. LS mean difference = Omadacycline minus Placebo.|ANCOVA||Treatment comparison between Omadacycline and Placebo for total score has been presented.|||5.99|-7.58|0.8161
72418620|NCT04922554|144347563|OTHER|Endpoints are summarized using descriptive statistics. Inferential testing of pre-specified hypothesis was not completed.|Least square mean difference|-5.7||||0.001|TWO_SIDED|95.0|-8.95|-2.38||ANCOVA analyzed change from baseline using treatment, prior antibiotic use, and baseline score as factors. LS mean difference = Omadacycline minus Placebo.|ANCOVA|||||-2.38|-8.95|0.0010
72418621|NCT04922554|144347564|OTHER|Endpoints are summarized using descriptive statistics. Inferential testing of pre-specified hypothesis was not completed.|Difference in improvement rates|39.61||||0.002|TWO_SIDED|95.0|16.66|62.56|||Fisher Exact|||||62.56|16.66|0.0020
72418622|NCT04922554|144347565|OTHER|Endpoints are summarized using descriptive statistics. Inferential testing of pre-specified hypothesis was not completed.|Difference in improvement rates|15.41||||0.3051|TWO_SIDED|95.0|-9.1|39.93|||Fisher Exact|||||39.93|-9.10|0.3051
72418623|NCT04922554|144347566|OTHER|Endpoints are summarized using descriptive statistics. Inferential testing of pre-specified hypothesis was not completed.||||||0.3552|||||||Wilcoxon rank sum test|||||||0.3552
72418624|NCT04922554|144347567|OTHER|Endpoints are summarized using descriptive statistics. Inferential testing of pre-specified hypothesis was not completed.||||||0.0753|||||||Wilcoxon rank sum test|||||||0.0753
72418625|NCT04922554|144347569|OTHER|Endpoints are summarized using descriptive statistics. Inferential testing of pre-specified hypothesis was not completed.|Odds Ratio (OR)|3.84||||0.0168|TWO_SIDED|95.0|1.24|11.87|||Chi-squared|||||11.87|1.24|0.0168
72611267|NCT00909870|144751349|SUPERIORITY_OR_OTHER||Difference in proportions|6.5||||0.103|TWO_SIDED|95.0||||This p-value did not meet the prespecified threshold for statistical significance of \< 0.05|Chi-squared|Unadjusted||"H0: the proportion of responders in the Dermagraft group = the proportion of responders in the Control group.~HA: the proportion of responders in the Dermagraft group ≠ the proportion of responders in the Control group.~The proportion of responders in the Dermagraft group was compared with the proportion of responders in the control group using the uncorrected chi-square test for 2x2 contingency tables. The difference between the groups was expected to be 13%."||||0.1030
72418626|NCT04922554|144347570|OTHER|Endpoints are summarized using descriptive statistics. Inferential testing of pre-specified hypothesis was not completed.||||||0.0233|||||||Log Rank|||||||0.0233
72611268|NCT00909870|144751350|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|6.0||||0.4046||95.0||||This p-value did not meet the prespecified threshold for statistical significance of \< 0.05|Log Rank|||||||0.4046
72611269|NCT00909870|144751351|SUPERIORITY_OR_OTHER||Difference in proportions|10.0||||0.0239||95.0||||Unadjusted|Chi-squared|Unadjusted||Pre-specified subgroup analysis of the primary endpoint||||0.0239
72326404|NCT01475721|144176026|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.834||||0.203|TWO_SIDED|95.0|0.63|1.103|||Regression, Cox||Analysis of time to first exacerbation in efficacy subgroup: Subjects not well-controlled on prior ICS or non-LABA therapy.|The hazard ratio computed is essentially the relative risk of having the event in the treatment group relative to the control group, adjusted for time to the event.||1.103|0.630|0.203
72418627|NCT04922554|144347571|OTHER|Endpoints are summarized using descriptive statistics. Inferential testing of pre-specified hypothesis was not completed.||||||0.0349|||||||Log Rank|||||||0.0349
72418628|NCT00772590|144347599|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED|95.0|||||ANOVA|||||||<0.01
72418629|NCT00152464|144347618|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.002|||=|0.991|TWO_SIDED|95.0|0.75|1.338|||Regression, Cox|||||1.338|0.750|=0.991
72418630|NCT00420199|144347630|SUPERIORITY_OR_OTHER||Adjusted Mean Difference from Placebo|-0.5|||||TWO_SIDED|95.0|-1.77|0.76|||ANCOVA|||Comparison in the change from baseline of erosion score using the OMERACT 6 RA MRI score method between Abatacept and Placebo at Day 113 was based on a non-parametric analysis of covariance model (ANCOVA). Change from BL = Post-BL measurement-BL value. Adjustment was based on ANCOVA model with treatment as a factor and BL value a covariate.||0.76|-1.77|
72611270|NCT01232283|144751352|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|23.0|||<|0.0001|TWO_SIDED|95.0|16.3|29.6|||Chi-squared|||||29.6|16.3|<0.0001
72611271|NCT01232283|144751353|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|16.1|||<|0.0001|TWO_SIDED|95.0|10.2|21.9|||Chi-squared|||||21.9|10.2|<0.0001
72611272|NCT01232283|144751354|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Mean|-42.15|||<|0.0001|TWO_SIDED|95.0|-51.11|-33.2|||ANCOVA|The model included treatment group as a factor and the baseline value as a covariate. The estimation and p-value were adjusted by the covariate.||||-33.20|-51.11|<0.0001
72418631|NCT00420199|144347631|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.96||||0.103||95.0|||||ANCOVA|||Comparison in change from baseline of wrist synovitis using OMERACT 6 rheumatoid arthritis magnetic resonance imaging score method between abatacept and placebo at Day 113 based on a nonparametric analysis of covariance model. Baseline and changes from baseline of the total wrist synovitis scores were ranked, and the model included the rank score for change from baseline as the dependent variable with treatment group as a main effect and the rank score for baseline as an additional covariate.||||0.103
72611273|NCT01232283|144751355|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-34.8|||<|0.0001|TWO_SIDED|95.0|-42.4|-27.2|||ANCOVA|The model included treatment group as a factor and the baseline value as a covariate. The estimation and p-value were adjusted by the covariate.||||-27.2|-42.4|<0.0001
72611274|NCT01232283|144751356|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|35.8|||<|0.0001|TWO_SIDED|95.0|26.9|44.7|||Chi-squared|||||44.7|26.9|< 0.0001
72611275|NCT01232283|144751357|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-21.3|||<|0.0001|TWO_SIDED|95.0|-28.4|-14.2|||ANCOVA|The model included treatment group as a factor and the baseline value as a covariate. The estimation and p-value were adjusted by the covariate.||||-14.2|-28.4|<0.0001
72611276|NCT01232283|144751358|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-4.0|||<|0.0001|TWO_SIDED|95.0|-5.3|-2.8|||ANCOVA|The model included treatment group as a factor and the baseline value as a covariate. The estimation and p-value were adjusted by the covariate.||||-2.8|-5.3|<0.0001
72611277|NCT01232283|144751359|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|2.63||||0.0078|TWO_SIDED|95.0|0.69|4.56|||ANCOVA|The model included treatment group as a factor and the baseline value as a covariate. The estimation and p-value were adjusted by the covariate.||||4.56|0.69|0.0078
72611278|NCT01232283|144751360|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|14.2|||<|0.0001|TWO_SIDED|95.0|8.5|20.0|||Chi-squared|||||20.0|8.5|<0.0001
72611279|NCT01232283|144751361|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|7.7|||<|0.0001|TWO_SIDED|95.0|3.408|17.399|||Log Rank|||||17.399|3.408|<0.0001
72611280|NCT04773028|144751366|OTHER||Mean Difference (Final Values)|-93054.0|||<|0.05|TWO_SIDED||||||t-test, 2 sided|||||||<0.05
72611281|NCT02966834|144751382|OTHER||Mean Difference (Net)|-0.47|||||TWO_SIDED|95.0|-1.75|0.82||||||||0.82|-1.75|
72326405|NCT01475721|144176026|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.839||||0.188|TWO_SIDED|95.0|0.645|1.09|||Regression, Cox||Analysis of time to first exacerbation in efficacy subgroup: Subjects not well-controlled on prior ICS+LABA therapy|The hazard ratio computed is essentially the relative risk of having the event in the treatment group relative to the control group, adjusted for time to the event.||1.090|0.645|0.188
72611282|NCT02966834|144751382|OTHER||Mean Difference (Net)|-0.88|||||TWO_SIDED|95.0|-2.07|0.31||||||||0.31|-2.07|
72611283|NCT02966834|144751382|OTHER||Mean Difference (Net)|-0.88|||||TWO_SIDED|95.0|-2.03|0.28||||||||0.28|-2.03|
72611284|NCT02966834|144751382|OTHER||Mean Difference (Net)|-1.13|||||TWO_SIDED|95.0|-2.29|0.03||||||||0.03|-2.29|
72611285|NCT02966834|144751382|OTHER||Mean Difference (Net)|-0.53|||||TWO_SIDED|95.0|-1.71|0.65||||||||0.65|-1.71|
72611286|NCT02966834|144751383|OTHER||Mean Difference (Net)|0.2|||||TWO_SIDED|95.0|-1.9|2.3|||||Symptoms|||2.3|-1.9|
72611287|NCT02966834|144751383|OTHER||Mean Difference (Net)|0.5|||||TWO_SIDED|95.0|-1.5|2.5|||||Symptoms|||2.5|-1.5|
72611288|NCT02966834|144751383|OTHER||Mean Difference (Net)|-1.1|||||TWO_SIDED|95.0|-3.1|0.8|||||Symptoms|||0.8|-3.1|
72611289|NCT02966834|144751383|OTHER||Mean Difference (Net)|0.1|||||TWO_SIDED|95.0|-1.8|2.0|||||Symptoms|||2.0|-1.8|
72611290|NCT02966834|144751383|OTHER||Mean Difference (Net)|0.0|||||TWO_SIDED|95.0|-2.0|1.9|||||Symptoms|||1.9|-2.0|
72611291|NCT02966834|144751383|OTHER||Mean Difference (Net)|0.5|||||TWO_SIDED|95.0|-1.3|2.2|||||Itch|||2.2|-1.3|
72611292|NCT02966834|144751383|OTHER||Mean Difference (Net)|-0.3|||||TWO_SIDED|95.0|-1.8|1.3|||||Itch|||1.3|-1.8|
72611293|NCT02966834|144751383|OTHER||Mean Difference (Net)|-0.3|||||TWO_SIDED|95.0|-1.9|1.2|||||Itch|||1.2|-1.9|
72611294|NCT02966834|144751383|OTHER||Mean Difference (Net)|-1.0|||||TWO_SIDED|95.0|-2.6|0.5|||||Itch|||0.5|-2.6|
72611295|NCT02966834|144751383|OTHER||Mean Difference (Net)|-0.3|||||TWO_SIDED|95.0|-1.9|1.3|||||Itch|||1.3|-1.9|
72611296|NCT02966834|144751383|OTHER||Mean Difference (Net)|-0.6|||||TWO_SIDED|95.0|-4.5|3.2|||||Fatigue|||3.2|-4.5|
72611297|NCT02966834|144751383|OTHER||Median Difference (Net)|0.7|||||TWO_SIDED|95.0|-2.8|4.2|||||Fatigue|||4.2|-2.8|
72611298|NCT02966834|144751383|OTHER||Mean Difference (Net)|3.5|||||TWO_SIDED|95.0|0.0|7.0|||||Fatigue|||7.0|0.0|
72611299|NCT02966834|144751383|OTHER||Mean Difference (Net)|1.7|||||TWO_SIDED|95.0|-1.8|5.1|||||Fatigue|||5.1|-1.8|
72611300|NCT02966834|144751383|OTHER||Mean Difference (Net)|0.0|||||TWO_SIDED|95.0|-3.6|3.6|||||Fatigue|||3.6|-3.6|
72611301|NCT02966834|144751383|OTHER||Mean Difference (Net)|0.0|||||TWO_SIDED|95.0|-2.5|2.6|||||Cognitive|||2.6|-2.5|
72611302|NCT02966834|144751383|OTHER||Mean Difference (Net)|-0.6|||||TWO_SIDED|95.0|-2.9|1.7|||||Cognitive|||1.7|-2.9|
72611303|NCT02966834|144751383|OTHER||Mean Difference (Net)|0.2|||||TWO_SIDED|95.0|-2.1|2.5|||||Cognitive|||2.5|-2.1|
72611304|NCT02966834|144751383|OTHER||Mean Difference (Net)|0.5|||||TWO_SIDED|95.0|-1.8|2.8|||||Cognitive|||2.8|-1.8|
72611305|NCT02966834|144751383|OTHER||Mean Difference (Net)|0.2|||||TWO_SIDED|95.0|-2.2|2.5|||||Cognitive|||2.5|-2.2|
72611306|NCT02966834|144751383|OTHER||Mean Difference (Net)|-0.9|||||TWO_SIDED|95.0|-2.1|0.4|||||Emotional|||0.4|-2.1|
72611307|NCT02966834|144751383|OTHER||Mean Difference (Net)|0.2|||||TWO_SIDED|95.0|-0.9|1.3|||||Emotional|||1.3|-0.9|
72611308|NCT02966834|144751383|OTHER||Mean Difference (Net)|-0.1|||||TWO_SIDED|95.0|-1.2|1.1|||||Emotional|||1.1|-1.2|
72326406|NCT01475721|144176026|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.764||||0.002|TWO_SIDED|95.0|0.645|0.905|||Regression, Cox||Analysis of time to first exacerbation in efficacy subgroup: Subjects controlled on prior ICS+LABA therapy|The hazard ratio computed is essentially the relative risk of having the event in the treatment group relative to the control group, adjusted for time to the event.||0.905|0.645|0.002
72326407|NCT01475721|144176026|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.682||||0.071|TWO_SIDED|95.0|0.451|1.034|||Regression, Cox||Analysis of time to first exacerbation in efficacy subgroup: Subjects controlled on prior ICS therapy|The hazard ratio computed is essentially the relative risk of having the event in the treatment group relative to the control group, adjusted for time to the event.||1.034|0.451|0.071
72418632|NCT00420199|144347633|SUPERIORITY_OR_OTHER||Adjusted Mean Difference from Placebo|-3.48|||||TWO_SIDED|95.0|-6.0|-0.96|||ANCOVA|||Comparison in the change from baseline of Edema/Osteitis score using the OMERACT 6 RA MRI score method between Abatacept and Placebo at Day 113 was based on a non-parametric analysis of covariance model (ANCOVA). Change from BL = Post-BL measurement-BL value. Adjustment was based on ANCOVA model with treatment as a factor and BL value a covariate.||-0.96|-6.00|
72611309|NCT02966834|144751383|OTHER||Mean Difference (Net)|-0.8|||||TWO_SIDED|95.0|-1.9|0.3|||||Emotional|||0.3|-1.9|
72611310|NCT02966834|144751383|OTHER||Mean Difference (Net)|0.0|||||TWO_SIDED|95.0|-1.2|1.1|||||Emotional|||1.1|-1.2|
72611311|NCT02966834|144751383|OTHER||Mean Difference (Net)|0.3|||||TWO_SIDED|95.0|-2.4|3.0|||||Social|||3.0|-2.4|
72611312|NCT02966834|144751383|OTHER||Mean Difference (Net)|1.2|||||TWO_SIDED|95.0|-1.3|3.7|||||Social|||3.7|-1.3|
72611313|NCT02966834|144751383|OTHER||Mean Difference (Net)|0.2|||||TWO_SIDED|95.0|-2.3|2.7|||||Social|||2.7|-2.3|
72611314|NCT02966834|144751383|OTHER||Mean Difference (Net)|-2.4|||||TWO_SIDED|95.0|-4.8|0.1|||||Social|||0.1|-4.8|
72611315|NCT02966834|144751383|OTHER||Mean Difference (Net)|-0.2|||||TWO_SIDED|95.0|-2.8|2.4|||||Social|||2.4|-2.8|
72611316|NCT02966834|144751384|OTHER||Mean Difference (Net)|-106.8|||||TWO_SIDED|95.0|-251.7|38.2||||||||38.2|-251.7|
72611317|NCT02966834|144751384|OTHER||Mean Difference (Net)|-87.4|||||TWO_SIDED|95.0|-198.5|23.8||||||||23.8|-198.5|
72611318|NCT02966834|144751384|OTHER||Mean Difference (Net)|0.4|||||TWO_SIDED|95.0|-125.6|126.5||||||||126.5|-125.6|
72611319|NCT02966834|144751384|OTHER||Mean Difference (Net)|-78.3|||||TWO_SIDED|95.0|-211.5|54.8||||||||54.8|-211.5|
72611320|NCT02966834|144751384|OTHER||Mean Difference (Net)|-30.0|||||TWO_SIDED|95.0|-170.7|110.7||||||||110.7|-170.7|
72611321|NCT02966834|144751386|OTHER||Mean Difference (Net)|-21.4|||||TWO_SIDED|95.0|-58.4|15.5||||||||15.5|-58.4|
72611322|NCT02966834|144751386|OTHER||Mean Difference (Net)|-12.7|||||TWO_SIDED|95.0|-41.9|16.4||||||||16.4|-41.9|
72611323|NCT02966834|144751386|OTHER||Mean Difference (Net)|-15.0|||||TWO_SIDED|95.0|-49.9|20.0||||||||20.0|-49.9|
72611324|NCT02966834|144751386|OTHER||Mean Difference (Net)|-26.5|||||TWO_SIDED|95.0|-63.3|10.4||||||||10.4|-63.3|
72611325|NCT02966834|144751386|OTHER||Mean Difference (Net)|0.2|||||TWO_SIDED|95.0|-36.7|37.1||||||||37.1|-36.7|
72611326|NCT02966834|144751387|OTHER||Mean Difference (Net)|-20.0|||||TWO_SIDED|95.0|-52.73|12.74||||||||12.74|-52.73|
72611327|NCT02966834|144751387|OTHER||Mean Difference (Net)|-24.7|||||TWO_SIDED|95.0|-50.8|1.39||||||||1.39|-50.80|
72611328|NCT02966834|144751387|OTHER||Mean Difference (Net)|-22.61|||||TWO_SIDED|95.0|-53.39|8.16||||||||8.16|-53.39|
72611329|NCT02966834|144751387|OTHER||Mean Difference (Net)|-31.67|||||TWO_SIDED|95.0|-63.44|0.09||||||||0.09|-63.44|
72611330|NCT02966834|144751387|OTHER||Mean Difference (Net)|-5.79|||||TWO_SIDED|95.0|-38.33|26.74||||||||26.74|-38.33|
72611331|NCT02966834|144751388|OTHER||Mean Difference (Net)|-106.0|||||TWO_SIDED|95.0|-205.1|-6.8||||||||-6.8|-205.1|
72611332|NCT02966834|144751388|OTHER||Mean Difference (Net)|-65.5|||||TWO_SIDED|95.0|-148.5|17.6||||||||17.6|-148.5|
72611333|NCT02966834|144751388|OTHER||Mean Difference (Net)|-42.8|||||TWO_SIDED|95.0|-136.5|50.9||||||||50.9|-136.5|
72611334|NCT02966834|144751388|OTHER||Mean Difference (Net)|-65.8|||||TWO_SIDED|95.0|-161.2|29.5||||||||29.5|-161.2|
72611335|NCT02966834|144751388|OTHER||Mean Difference (Net)|-54.1|||||TWO_SIDED|95.0|-153.6|45.3||||||||45.3|-153.6|
72611336|NCT02966834|144751389|OTHER||Mean Difference (Net)|-6.099|||||TWO_SIDED|95.0|-11.929|-0.268||||||||-0.268|-11.929|
72611337|NCT02966834|144751389|OTHER||Mean Difference (Net)|-2.337|||||TWO_SIDED|95.0|-6.962|2.289||||||||2.289|-6.962|
72611338|NCT02966834|144751389|OTHER||Mean Difference (Net)|-2.232|||||TWO_SIDED|95.0|-7.679|3.215||||||||3.215|-7.679|
72611339|NCT02966834|144751389|OTHER||Mean Difference (Net)|-1.492|||||TWO_SIDED|95.0|-7.413|4.43||||||||4.430|-7.413|
72611340|NCT02966834|144751389|OTHER||Mean Difference (Net)|5.236|||||TWO_SIDED|95.0|-0.591|11.063||||||||11.063|-0.591|
72611341|NCT02966834|144751390|OTHER||Mean Difference (Net)|-0.5|||||TWO_SIDED|95.0|-2.7|1.6||||||||1.6|-2.7|
72611342|NCT02966834|144751390|OTHER||Mean Difference (Net)|0.3|||||TWO_SIDED|95.0|-1.5|2.1||||||||2.1|-1.5|
72611343|NCT02966834|144751390|OTHER||Mean Difference (Net)|0.7|||||TWO_SIDED|95.0|-1.2|2.7||||||||2.7|-1.2|
72611344|NCT02966834|144751390|OTHER||Mean Difference (Net)|0.0|||||TWO_SIDED|95.0|-2.1|2.0||||||||2.0|-2.1|
72611345|NCT02966834|144751390|OTHER||Mean Difference (Net)|0.7|||||TWO_SIDED|95.0|-1.5|2.9||||||||2.9|-1.5|
72611346|NCT02966834|144751391|OTHER||Mean Difference (Net)|-0.02|||||TWO_SIDED|95.0|-0.08|0.04||||||||0.04|-0.08|
72611347|NCT02966834|144751391|OTHER||Mean Difference (Net)|-0.04|||||TWO_SIDED|95.0|-0.09|0.01||||||||0.01|-0.09|
72611348|NCT02966834|144751391|OTHER||Mean Difference (Net)|0.0|||||TWO_SIDED|95.0|-0.06|0.05||||||||0.05|-0.06|
72611349|NCT02966834|144751391|OTHER||Mean Difference (Net)|-0.03|||||TWO_SIDED|95.0|-0.09|0.02||||||||0.02|-0.09|
72611350|NCT02966834|144751391|OTHER||Mean Difference (Net)|-0.04|||||TWO_SIDED|95.0|-0.1|0.02||||||||0.02|-0.10|
72611351|NCT02966834|144751392|OTHER||Mean Difference (Net)|0.15|||||TWO_SIDED|95.0|-0.33|0.63||||||||0.63|-0.33|
72611352|NCT02966834|144751392|OTHER||Mean Difference (Net)|-0.11|||||TWO_SIDED|95.0|-0.51|0.3||||||||0.30|-0.51|
72611353|NCT02966834|144751392|OTHER||Mean Difference (Net)|0.12|||||TWO_SIDED|95.0|-0.34|0.58||||||||0.58|-0.34|
72611354|NCT02966834|144751392|OTHER||Mean Difference (Net)|-0.08|||||TWO_SIDED|95.0|-0.54|0.38||||||||0.38|-0.54|
72611355|NCT02966834|144751392|OTHER||Mean Difference (Net)|-0.07|||||TWO_SIDED|95.0|-0.54|0.41||||||||0.41|-0.54|
72611356|NCT02966834|144751402|OTHER||Odds Ratio (OR)|2.89|||||TWO_SIDED|95.0|0.69|12.02|||||Analysis was performed using Logistic regression. No covariates were used.|||12.02|0.69|
72611357|NCT02966834|144751402|OTHER||Odds Ratio (OR)|1.56|||||TWO_SIDED|95.0|0.48|5.02|||||Analysis was performed using Logistic regression. No covariates were used.|||5.02|0.48|
72418633|NCT00420199|144347636|SUPERIORITY_OR_OTHER||Adjusted Mean Difference from Placebo|-4.71|||||TWO_SIDED|95.0|-8.0|-1.42|||ANCOVA|||Comparison in the change from baseline of RAMRIS score using the OMERACT 6 RA MRI score method between Abatacept and Placebo at Day 113 was based on a non-parametric analysis of covariance model (ANCOVA). Change from BL = Post-BL measurement-BL value. Adjustment was based on ANCOVA model with treatment as a factor and BL value a covariate.||-1.42|-8.00|
72418634|NCT00420199|144347650|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.69||||0.078||95.0|||||ANCOVA|||Comparison in change from baseline of wrist synovitis using OMERACT 6 rheumatoid arthritis magnetic resonance imaging (MRI) score method between ABA and PLA at Day 113 based on a parametric analysis of covariance model (ANCOVA). The model included the score change from baseline as the dependent variable, treatment group as a main effect and baseline score as an additional covariate.||||0.078
72418635|NCT00430248|144347653|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority of febuxostat 40 mg to allopurinol was declared if the value of the lower bound of the 95% confidence interval for the difference was greater than -10%.|Difference in percentage|3.1||||||95.0|-1.9|8.1||||||The primary comparison was between febuxostat 40 mg and allopurinol treatment groups.||8.1|-1.9|
72418636|NCT00430248|144347653|SUPERIORITY_OR_OTHER|||||||0.233||95.0||||The test for superiority was performed using Fisher's exact test (two-tailed 0.05 significance level).|Fisher Exact|||||||0.233
72418637|NCT00430248|144347653|SUPERIORITY_OR_OTHER||Difference in percentage|24.9|||<|0.001||95.0|20.1|29.8||Comparisons between treatment groups were performed using Fisher's exact test (two-tailed 0.05 significance level).|Fisher Exact|||||29.8|20.1|<0.001
72418638|NCT00430248|144347653|SUPERIORITY_OR_OTHER||Difference in percentage|21.9|||<|0.001||95.0|17.0|26.8||Comparisons between treatment groups were performed using Fisher's exact test (two-tailed 0.05 significance level).|Fisher Exact|||||26.8|17.0|<0.001
72418639|NCT00430248|144347654|SUPERIORITY_OR_OTHER|||||||0.021||95.0||||The a priori threshold for statistical significance was 0.05 (two-tailed).|Fisher Exact|||||||0.021
72418640|NCT00430248|144347654|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The a priori threshold for statistical significance was 0.05 (two-tailed).|Fisher Exact|||||||<0.001
72418641|NCT00430248|144347654|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The a priori threshold for statistical significance was 0.05 (two-tailed).|Fisher Exact|||||||<0.001
72418642|NCT00430248|144347655|SUPERIORITY_OR_OTHER|||||||0.031||95.0||||The a priori threshold for statistical significance was 0.05 (two-tailed).|Fisher Exact|||||||0.031
72418643|NCT00430248|144347655|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The a priori threshold for statistical significance was 0.05 (two-tailed).|Fisher Exact|||||||<0.001
72418644|NCT00430248|144347655|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The a priori threshold for statistical significance was 0.05 (two-tailed).|Fisher Exact|||||||<0.001
72418645|NCT00430248|144347656|SUPERIORITY_OR_OTHER|||||||0.578||95.0||||The a priori threshold for statistical significance was 0.05 (two-tailed).|Fisher Exact|||||||0.578
72418646|NCT00430248|144347656|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The a priori threshold for statistical significance was 0.05 (two-tailed).|Fisher Exact|||||||<0.001
72418647|NCT00430248|144347656|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The a priori threshold for statistical significance was 0.05 (two-tailed).|Fisher Exact|||||||<0.001
72418648|NCT00430248|144347657|SUPERIORITY_OR_OTHER|||||||0.426||95.0||||The a priori threshold for statistical significance was 0.05 (two-tailed).|Fisher Exact|||||||0.426
72418649|NCT00430248|144347657|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The a priori threshold for statistical significance was 0.05 (two-tailed).|Fisher Exact|||||||<0.001
72611358|NCT02966834|144751402|OTHER||Odds Ratio (OR)|3.0|||||TWO_SIDED|95.0|0.84|10.76|||||Analysis was performed using Logistic regression. No covariates were used.|||10.76|0.84|
72418650|NCT00430248|144347657|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The a priori threshold for statistical significance was 0.05 (two-tailed).|Fisher Exact|||||||<0.001
72418651|NCT00430248|144347658|SUPERIORITY_OR_OTHER|||||||0.05||95.0||||The a priori threshold for statistical significance was 0.05 (two-tailed).|Fisher Exact|||||||0.050
72418652|NCT00430248|144347658|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The a priori threshold for statistical significance was 0.05 (two-tailed).|Fisher Exact|||||||<0.001
72418653|NCT00430248|144347658|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The a priori threshold for statistical significance was 0.05 (two-tailed).|Fisher Exact|||||||<0.001
72418654|NCT00430248|144347659|SUPERIORITY_OR_OTHER|||||||0.428||95.0||||The a priori threshold for statistical significance was 0.05 (two-tailed).|Fisher Exact|||||||0.428
72418655|NCT00430248|144347659|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The a priori threshold for statistical significance was 0.05 (two-tailed).|Fisher Exact|||||||<0.001
72418656|NCT00430248|144347659|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The a priori threshold for statistical significance was 0.05 (two-tailed).|Fisher Exact|||||||<0.001
72418657|NCT00430248|144347660|SUPERIORITY_OR_OTHER|||||||0.041||95.0||||The a priori threshold for statistical significance was 0.05 (two-tailed).|Fisher Exact|||||||0.041
72418658|NCT00430248|144347660|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The a priori threshold for statistical significance was 0.05 (two-tailed).|Fisher Exact|||||||<0.001
72418659|NCT00430248|144347660|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The a priori threshold for statistical significance was 0.05 (two-tailed).|Fisher Exact|||||||<0.001
72418660|NCT00430248|144347661|SUPERIORITY_OR_OTHER|||||||0.083||95.0||||The a priori threshold for statistical significance was 0.05 (two-tailed).|Fisher Exact|||||||0.083
72418661|NCT00430248|144347661|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The a priori threshold for statistical significance was 0.05 (two-tailed).|Fisher Exact|||||||<0.001
72418662|NCT00430248|144347661|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The a priori threshold for statistical significance was 0.05 (two-tailed).|Fisher Exact|||||||<0.001
72418663|NCT00430248|144347662|SUPERIORITY_OR_OTHER|||||||0.421||95.0||||The a priori threshold for statistical significance was 0.05 (two-tailed).|Fisher Exact|||||||0.421
72418664|NCT00430248|144347662|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The a priori threshold for statistical significance was 0.05 (two-tailed).|Fisher Exact|||||||<0.001
72418665|NCT00430248|144347662|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The a priori threshold for statistical significance was 0.05 (two-tailed).|Fisher Exact|||||||<0.001
72418666|NCT00430248|144347663|SUPERIORITY_OR_OTHER|||||||0.52||95.0||||The a priori threshold for statistical significance was 0.05 (two-tailed).|Fisher Exact|||||||0.520
72611359|NCT02966834|144751402|OTHER||Odds Ratio (OR)|3.0|||||TWO_SIDED|95.0|0.84|10.76|||||Analysis was performed using Logistic regression. No covariates were used.|||10.76|0.84|
72418667|NCT00430248|144347663|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The a priori threshold for statistical significance was 0.05 (two-tailed).|Fisher Exact|||||||<0.001
72418668|NCT00430248|144347663|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The a priori threshold for statistical significance was 0.05 (two-tailed).|Fisher Exact|||||||<0.001
72418669|NCT00430248|144347664|SUPERIORITY_OR_OTHER|||||||0.195||95.0||||The a priori threshold for statistical significance was 0.05 (two-tailed).|Fisher Exact|||||||0.195
72418670|NCT00430248|144347664|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The a priori threshold for statistical significance was 0.05 (two-tailed).|Fisher Exact|||||||<0.001
72418671|NCT00430248|144347664|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The a priori threshold for statistical significance was 0.05 (two-tailed).|Fisher Exact|||||||<0.001
72418672|NCT00430248|144347665|SUPERIORITY_OR_OTHER|||||||0.196||95.0||||The a priori threshold for statistical significance was 0.05 (two-tailed).|Fisher Exact|||||||0.196
72418673|NCT00430248|144347665|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The a priori threshold for statistical significance was 0.05 (two-tailed).|Fisher Exact|||||||<0.001
72418674|NCT00430248|144347665|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The a priori threshold for statistical significance was 0.05 (two-tailed).|Fisher Exact|||||||<0.001
72418675|NCT00430248|144347666|SUPERIORITY_OR_OTHER|||||||0.079||95.0||||P-value is from contrast within the framework of the ANOVA with significance at the 0.05 level.|ANOVA|||||||0.079
72418676|NCT00430248|144347666|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is from contrast within the framework of the ANOVA with significance at the 0.05 level.|ANOVA|||||||<0.001
72611360|NCT02966834|144751402|OTHER||Odds Ratio (OR)|1.33|||||TWO_SIDED|95.0|0.43|4.13|||||Analysis was performed using Logistic regression. No covariates were used.|||4.13|0.43|
72611361|NCT02966834|144751403|OTHER||Odds Ratio (OR)|1.36|||||TWO_SIDED|95.0|0.41|4.47|||||Analysis was performed using Logistic regression. No covariates were used.|||4.47|0.41|
72326408|NCT01475721|144176026|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.878||||0.373|TWO_SIDED|95.0|0.659|1.17|||Regression, Cox||Analysis of number of asthma exacerbations in efficacy subgroup: Subjects not well-controlled on prior ICS or non-LABA therapy|The hazard ratio computed is essentially the relative risk of having the event in the treatment group relative to the control group, adjusted for time to the event.||1.170|0.659|0.373
72611362|NCT02966834|144751403|OTHER||Odds Ratio (OR)|3.18|||||TWO_SIDED|95.0|0.95|10.65|||||Analysis was performed using Logistic regression. No covariates were used.|||10.65|0.95|
72611363|NCT02966834|144751403|OTHER||Odds Ratio (OR)|1.85|||||TWO_SIDED|95.0|0.62|5.53|||||Analysis was performed using Logistic regression. No covariates were used.|||5.53|0.62|
72611364|NCT02966834|144751403|OTHER||Odds Ratio (OR)|2.27|||||TWO_SIDED|95.0|0.74|6.92|||||Analysis was performed using Logistic regression. No covariates were used.|||6.92|0.74|
72611365|NCT02966834|144751403|OTHER||Odds Ratio (OR)|2.12|||||TWO_SIDED|95.0|0.69|6.51|||||Analysis was performed using Logistic regression. No covariates were used.|||6.51|0.69|
72611366|NCT02966834|144751404|OTHER||Odds Ratio (OR)|0.9|||||TWO_SIDED|95.0|0.27|3.04|||||Analysis was performed using Logistic regression. No covariates were used.|||3.04|0.27|
72611367|NCT02966834|144751404|OTHER||Odds Ratio (OR)|2.25|||||TWO_SIDED|95.0|0.73|6.91|||||Analysis was performed using Logistic regression. No covariates were used.|||6.91|0.73|
72611368|NCT02966834|144751404|OTHER||Odds Ratio (OR)|1.04|||||TWO_SIDED|95.0|0.35|3.08|||||Analysis was performed using Logistic regression. No covariates were used.|||3.08|0.35|
72418677|NCT00430248|144347666|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is from contrast within the framework of the ANOVA with significance at the 0.05 level.|ANOVA|||||||<0.001
72418678|NCT00430248|144347667|SUPERIORITY_OR_OTHER|||||||0.685||95.0||||P-value is from contrast within the framework of the ANOVA with significance at the 0.05 level.|ANOVA|||||||0.685
72418679|NCT00430248|144347667|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is from contrast within the framework of the ANOVA with significance at the 0.05 level.|ANOVA|||||||<0.001
72418680|NCT00430248|144347667|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is from contrast within the framework of the ANOVA with significance at the 0.05 level.|ANOVA|||||||<0.001
72418681|NCT00430248|144347668|SUPERIORITY_OR_OTHER|||||||0.153||95.0||||P-value is from contrast within the framework of the ANOVA with significance at the 0.05 level.|ANOVA|||||||0.153
72418682|NCT00430248|144347668|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is from contrast within the framework of the ANOVA with significance at the 0.05 level.|ANOVA|||||||<0.001
72418683|NCT00430248|144347668|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is from contrast within the framework of the ANOVA with significance at the 0.05 level.|ANOVA|||||||<0.001
72418684|NCT00430248|144347669|SUPERIORITY_OR_OTHER|||||||0.05||95.0||||P-value is from contrast within the framework of the ANOVA with significance at the 0.05 level.|ANOVA|||||||0.050
72418685|NCT00430248|144347669|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is from contrast within the framework of the ANOVA with significance at the 0.05 level.|ANOVA|||||||<0.001
72418686|NCT00430248|144347669|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is from contrast within the framework of the ANOVA with significance at the 0.05 level.|ANOVA|||||||<0.001
72418687|NCT03387579|144347670|SUPERIORITY|||||||0.59|||||||Fisher Exact|||||||0.590
72418688|NCT03387579|144347670|SUPERIORITY|||||||0.224|||||||Fisher Exact|||||||0.224
72418689|NCT03387579|144347670|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.00
72418690|NCT03387579|144347671|SUPERIORITY|||||||0.471|||||||Kruskal-Wallis|||||||0.471
72418691|NCT03387579|144347672|SUPERIORITY|||||||0.525|||||||Kruskal-Wallis|||||||0.525
72418692|NCT03387579|144347673|SUPERIORITY|||||||0.753|||||||Kruskal-Wallis|||||||0.753
72418693|NCT03387579|144347674|SUPERIORITY|||||||0.008|||||||Kruskal-Wallis|||||||0.008
72611369|NCT02966834|144751404|OTHER||Odds Ratio (OR)|2.17|||||TWO_SIDED|95.0|0.73|6.42|||||Analysis was performed using Logistic regression. No covariates were used.|||6.42|0.73|
72611370|NCT02966834|144751404|OTHER||Odds Ratio (OR)|2.0|||||TWO_SIDED|95.0|0.67|5.99|||||Analysis was performed using Logistic regression. No covariates were used.|||5.99|0.67|
72611371|NCT02966834|144751405|OTHER||Mean Difference (Net)|18.21|||||TWO_SIDED|95.0|-2.59|39.0||||||||39.00|-2.59|
72611372|NCT02966834|144751405|OTHER||Mean Difference (Net)|11.05|||||TWO_SIDED|95.0|-7.42|29.53||||||||29.53|-7.42|
72611373|NCT02966834|144751405|OTHER||Mean Difference (Net)|18.44|||||TWO_SIDED|95.0|0.82|36.06||||||||36.06|0.82|
72611374|NCT02966834|144751405|OTHER||Mean Difference (Net)|25.48|||||TWO_SIDED|95.0|7.0|43.95||||||||43.95|7.00|
72418694|NCT03387579|144347675|SUPERIORITY|||||||0.127|||||||Fisher Exact|||||||0.127
72418695|NCT03387579|144347676|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.00
72418696|NCT03387579|144347677|SUPERIORITY||estimate|8.553||||0.046|TWO_SIDED|||||Intralipid 20% reduction versus smoflipid 20%|Mixed Models Analysis||standard error 4.249|||||0.046
72611375|NCT02966834|144751405|OTHER||Mean Difference (Net)|13.26|||||TWO_SIDED|95.0|-5.47|31.99||||||||31.99|-5.47|
72611376|NCT02966834|144751406|OTHER||Mean Difference (Net)|14.99|||||TWO_SIDED|95.0|-5.13|35.1||||||||35.10|-5.13|
72611377|NCT02966834|144751406|OTHER||Mean Difference (Net)|6.97|||||TWO_SIDED|95.0|-10.9|24.84||||||||24.84|-10.90|
72326409|NCT01475721|144176026|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.864||||0.271|TWO_SIDED|95.0|0.665|1.122|||Regression, Cox||Analysis of number of asthma exacerbations in efficacy subgroup: Subjects not well-controlled on prior ICS+LABA therapy|The hazard ratio computed is essentially the relative risk of having the event in the treatment group relative to the control group, adjusted for time to the event.||1.122|0.665|0.271
72418697|NCT03387579|144347677|SUPERIORITY||estimate|7.023||||0.04|TWO_SIDED|||||Intralipid 20% historic versus smoflipid|Mixed Models Analysis||standard error 3.376|||||0.040
72418698|NCT03387579|144347677|SUPERIORITY||estimate|-1.53||||0.718|TWO_SIDED|||||Intralipid 20% Historic versus Intralipid 20% reduction|Mixed Models Analysis||standard error 4.231|||||0.718
72418699|NCT03387579|144347678|SUPERIORITY||estimate|13.436||||0.003|TWO_SIDED|||||Intralipid 20% reduction versus Smoflipid 20%|Mixed Models Analysis||standard error 4.440|||||0.003
72418700|NCT03387579|144347678|SUPERIORITY||estimate|3.936||||0.27|TWO_SIDED|||||Intralipid 20% historic versus Smoflipid 20%|Mixed Models Analysis||standard error 3.553|||||0.270
72611378|NCT02966834|144751406|OTHER||Mean Difference (Net)|11.78|||||TWO_SIDED|95.0|-5.27|28.82||||||||28.82|-5.27|
72611379|NCT02966834|144751406|OTHER||Mean Difference (Net)|21.83|||||TWO_SIDED|95.0|3.96|39.7||||||||39.70|3.96|
72418701|NCT03387579|144347678|SUPERIORITY||estimate|-9.5||||0.034|TWO_SIDED|||||Intralipid 20% historic versus Intralipid 20% reduction|Mixed Models Analysis||standard error 4.416|||||0.034
72611380|NCT02966834|144751406|OTHER||Mean Difference (Net)|21.58|||||TWO_SIDED|95.0|3.46|39.69||||||||39.69|3.46|
72611381|NCT02966834|144751407|OTHER||Mean Difference (Net)|6.15|||||TWO_SIDED|95.0|-14.76|27.06||||||||27.06|-14.76|
72418702|NCT03387579|144347679|SUPERIORITY||estimate|42.674||||0.006|TWO_SIDED|||||Intralipid 20% reduction versus Smoflipid 20%|Mixed Models Analysis||standard error 15.216|||||0.006
72418703|NCT03387579|144347679|SUPERIORITY||estimate|11.117||||0.305|TWO_SIDED|||||Intralipid 20% historic versus smoflipid 20%|Mixed Models Analysis||standard error 10.771|||||0.305
72418704|NCT03387579|144347679|SUPERIORITY||estimate|-31.557|||<|0.001|TWO_SIDED|||||Intralipid 20% historic versus Intralipid 20% reduction|Mixed Models Analysis||standard error 67.673|||||<0.001
72418705|NCT03387579|144347680|SUPERIORITY||estimate|-0.593||||0.835|TWO_SIDED|||||Intralipid 20% reduction versus smoflipid 20%|Mixed Models Analysis||standard error 2.848|||||0.835
72611382|NCT02966834|144751407|OTHER||Mean Difference (Net)|7.26|||||TWO_SIDED|95.0|-11.32|25.84||||||||25.84|-11.32|
72611383|NCT02966834|144751407|OTHER||Mean Difference (Net)|9.13|||||TWO_SIDED|95.0|-8.59|26.85||||||||26.85|-8.59|
72611384|NCT02966834|144751407|OTHER||Mean Difference (Net)|19.94|||||TWO_SIDED|95.0|1.36|38.51||||||||38.51|1.36|
72611385|NCT02966834|144751407|OTHER||Mean Difference (Net)|27.04|||||TWO_SIDED|95.0|8.2|45.87||||||||45.87|8.20|
72611386|NCT02966834|144751408|OTHER||Mean Difference (Net)|-0.27|||||TWO_SIDED|95.0|-1.46|0.92||||||||0.92|-1.46|
72611387|NCT02966834|144751408|OTHER||Mean Difference (Net)|-0.48|||||TWO_SIDED|95.0|-1.58|0.62||||||||0.62|-1.58|
72611388|NCT02966834|144751408|OTHER||Mean Difference (Net)|-0.46|||||TWO_SIDED|95.0|-1.53|0.61||||||||0.61|-1.53|
72611389|NCT02966834|144751408|OTHER||Mean Difference (Net)|-0.96|||||TWO_SIDED|95.0|-2.03|0.12||||||||0.12|-2.03|
72611390|NCT02966834|144751408|OTHER||Mean Difference (Net)|-0.3|||||TWO_SIDED|95.0|-1.4|0.8||||||||0.80|-1.40|
72611391|NCT02966834|144751409|OTHER||Mean Difference (Net)|-0.39|||||TWO_SIDED|95.0|-1.49|0.71||||||||0.71|-1.49|
72611392|NCT02966834|144751409|OTHER||Mean Difference (Net)|-0.4|||||TWO_SIDED|95.0|-1.41|0.61||||||||0.61|-1.41|
72611393|NCT02966834|144751409|OTHER||Mean Difference (Net)|-0.26|||||TWO_SIDED|95.0|-1.24|0.72||||||||0.72|-1.24|
72611394|NCT02966834|144751409|OTHER||Mean Difference (Net)|-0.42|||||TWO_SIDED|95.0|-1.39|0.56||||||||0.56|-1.39|
72611395|NCT02966834|144751409|OTHER||Mean Difference (Net)|-0.29|||||TWO_SIDED|95.0|-1.28|0.7||||||||0.70|-1.28|
72611396|NCT02966834|144751410|OTHER||Mean Difference (Net)|-0.1|||||TWO_SIDED|95.0|-0.7|0.5|||||Duration|||0.5|-0.7|
72611397|NCT02966834|144751410|OTHER||Mean Difference (Net)|0.4|||||TWO_SIDED|95.0|-0.2|0.9|||||Duration|||0.9|-0.2|
72611398|NCT02966834|144751410|OTHER||Mean Difference (Net)|-0.4|||||TWO_SIDED|95.0|-1.0|0.1|||||Duration|||0.1|-1.0|
72611399|NCT02966834|144751410|OTHER||Mean Difference (Net)|0.2|||||TWO_SIDED|95.0|-0.3|0.7|||||Duration|||0.7|-0.3|
72611400|NCT02966834|144751410|OTHER||Mean Difference (Net)|0.1|||||TWO_SIDED|95.0|-0.4|0.6|||||Duration|||0.6|-0.4|
72611401|NCT02966834|144751410|OTHER||Mean Difference (Net)|-0.2|||||TWO_SIDED|95.0|-0.8|0.3|||||Degree|||0.3|-0.8|
72611402|NCT02966834|144751410|OTHER||Mean Difference (Net)|0.0|||||TWO_SIDED|95.0|-0.5|0.5|||||Degree|||0.5|-0.5|
72326410|NCT01475721|144176026|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.755||||0.001|TWO_SIDED|95.0|0.637|0.895|||Regression, Cox||Analysis of number of asthma exacerbations in efficacy subgroup: Subjects controlled on prior ICS+LABA therapy|The hazard ratio computed is essentially the relative risk of having the event in the treatment group relative to the control group, adjusted for time to the event.||0.895|0.637|0.001
72611403|NCT02966834|144751410|OTHER||Mean Difference (Net)|-0.1|||||TWO_SIDED|95.0|-0.6|0.5|||||Degree|||0.5|-0.6|
72611404|NCT02966834|144751410|OTHER||Mean Difference (Net)|-0.2|||||TWO_SIDED|95.0|-0.7|0.3|||||Degree|||0.3|-0.7|
72611405|NCT02966834|144751410|OTHER||Median Difference (Net)|-0.1|||||TWO_SIDED|95.0|-0.6|0.4|||||Degree|||0.4|-0.6|
72611406|NCT02966834|144751410|OTHER||Mean Difference (Net)|0.0|||||TWO_SIDED|95.0|-0.7|0.7|||||Direction|||0.7|-0.7|
72611407|NCT02966834|144751410|OTHER||Mean Difference (Net)|0.0|||||TWO_SIDED|95.0|-0.7|0.6|||||Direction|||0.6|-0.7|
72611408|NCT02966834|144751410|OTHER||Mean Difference (Net)|-0.2|||||TWO_SIDED|95.0|-0.8|0.5|||||Direction|||0.5|-0.8|
72611409|NCT02966834|144751410|OTHER||Mean Difference (Net)|-0.4|||||TWO_SIDED|95.0|-1.0|0.2|||||Direction|||0.2|-1.0|
72611410|NCT02966834|144751410|OTHER||Mean Difference (Net)|0.0|||||TWO_SIDED|95.0|-0.6|0.6|||||Direction|||0.6|-0.6|
72611411|NCT02966834|144751410|OTHER||Mean Difference (Net)|-0.4|||||TWO_SIDED|95.0|-1.1|0.3|||||Disability|||0.3|-1.1|
72611412|NCT02966834|144751410|OTHER||Mean Difference (Net)|-0.2|||||TWO_SIDED|95.0|-0.8|0.5|||||Disability|||0.5|-0.8|
72611413|NCT02966834|144751410|OTHER||Mean Difference (Net)|-0.3|||||TWO_SIDED|95.0|-1.0|0.3|||||Disability|||0.3|-1.0|
72611414|NCT02966834|144751410|OTHER||Mean Difference (Net)|-0.3|||||TWO_SIDED|95.0|-1.0|0.3|||||Disability|||0.3|-1.0|
72611415|NCT02966834|144751410|OTHER||Mean Difference (Net)|-0.3|||||TWO_SIDED|95.0|-1.0|0.3|||||Disability|||0.3|-1.0|
72611416|NCT02966834|144751410|OTHER||Mean Difference (Net)|-0.3|||||TWO_SIDED|95.0|-0.9|0.3|||||Distribution|||0.3|-0.9|
72611417|NCT02966834|144751410|OTHER||Median Difference (Net)|-0.3|||||TWO_SIDED|95.0|-0.9|0.2|||||Distribution|||0.2|-0.9|
72611418|NCT02966834|144751410|OTHER||Mean Difference (Net)|-0.5|||||TWO_SIDED|95.0|-1.0|0.0|||||Distribution|||0.0|-1.0|
72611419|NCT02966834|144751410|OTHER||Mean Difference (Net)|-0.3|||||TWO_SIDED|95.0|-0.9|0.2|||||Distribution|||0.2|-0.9|
72611420|NCT02966834|144751410|OTHER||Mean Difference (Net)|-0.2|||||TWO_SIDED|95.0|-0.7|0.3|||||Distribution|||0.3|-0.7|
72611421|NCT02966834|144751410|OTHER||Mean Difference (Net)|-1.0|||||TWO_SIDED|95.0|-3.3|1.3|||||5-D Itch Total Score|||1.3|-3.3|
72611422|NCT02966834|144751410|OTHER||Mean Difference (Net)|-0.1|||||TWO_SIDED|95.0|-2.2|2.1|||||5-D Itch Total Score|||2.1|-2.2|
72611423|NCT02966834|144751410|OTHER||Mean Difference (Net)|-1.4|||||TWO_SIDED|95.0|-3.5|0.7|||||5-D Itch Total Score|||0.7|-3.5|
72611424|NCT02966834|144751410|OTHER||Mean Difference (Net)|-0.9|||||TWO_SIDED|95.0|-3.0|1.2|||||5-D Itch Total Score|||1.2|-3.0|
72611425|NCT02966834|144751410|OTHER||Mean Difference (Net)|-0.6|||||TWO_SIDED|95.0|-2.7|1.6|||||5-D Itch Total Score|||1.6|-2.7|
72611426|NCT02966834|144751414|OTHER||Mean Difference (Net)|-0.71|||||TWO_SIDED|95.0|-1.69|0.28||||||||0.28|-1.69|
72418706|NCT03387579|144347680|SUPERIORITY||estimate|-0.522||||0.799|TWO_SIDED|||||Intralipid 20% historic versus smoflipid 20%|Mixed Models Analysis||standard error 2.050|||||0.799
72418707|NCT03387579|144347680|SUPERIORITY||estimate|0.714||||0.714|TWO_SIDED|||||Intralipid 20% historic versus Intralipid 20% reduction|Mixed Models Analysis||standard error 2.758|||||0.714
72611427|NCT02966834|144751414|OTHER||Mean Difference (Net)|-0.62|||||TWO_SIDED|95.0|-1.49|0.26||||||||0.26|-1.49|
72611428|NCT02966834|144751414|OTHER||Mean Difference (Net)|-0.9|||||TWO_SIDED|95.0|-1.76|-0.03||||||||-0.03|-1.76|
72611429|NCT02966834|144751414|OTHER||Mean Difference (Net)|-1.16|||||TWO_SIDED|95.0|-2.05|-0.28||||||||-0.28|-2.05|
72611430|NCT02966834|144751414|OTHER||Mean Difference (Net)|-0.95|||||TWO_SIDED|95.0|-1.85|-0.06||||||||-0.06|-1.85|
72611431|NCT02966834|144751415|OTHER||Least Square (LS) mean ratio|0.967|||||TWO_SIDED|95.0|0.635|1.471||||||||1.471|0.635|
72611432|NCT02966834|144751415|OTHER||LS mean ratio|1.17|||||TWO_SIDED|95.0|0.8|1.712||||||||1.712|0.8|
72611433|NCT02966834|144751415|OTHER||LS mean ratio|0.909|||||TWO_SIDED|95.0|0.627|1.316||||||||1.316|0.627|
72611434|NCT02966834|144751415|OTHER||LS mean ratio|0.69|||||TWO_SIDED|95.0|0.474|1.005||||||||1.005|0.474|
72611435|NCT02966834|144751415|OTHER||LS mean ratio|0.825|||||TWO_SIDED|95.0|0.564|1.207||||||||1.207|0.564|
72611436|NCT02966834|144751416|OTHER||LS mean ratio|1.363|||||TWO_SIDED|95.0|0.932|1.995||||||||1.995|0.932|
72611437|NCT02966834|144751416|OTHER||LS mean ratio|2.05|||||TWO_SIDED|95.0|1.456|2.887||||||||2.887|1.456|
72611438|NCT02966834|144751416|OTHER||LS mean ratio|2.457|||||TWO_SIDED|95.0|1.758|3.436||||||||3.436|1.758|
72611439|NCT02966834|144751416|OTHER||LS mean ratio|3.128|||||TWO_SIDED|95.0|2.206|4.435||||||||4.435|2.206|
72611440|NCT02966834|144751416|OTHER||LS mean ratio|2.701|||||TWO_SIDED|95.0|1.915|3.81||||||||3.81|1.915|
72611441|NCT01773928|144751433|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The probability that the modified process is noninferior to the current one (i.e. lower limit of the 95% CI of the ratio of geometric means \[modified vs. current\] is greater than or equal to 0.67) is above 99% for one strain, and it is around 97% for all three strains (considering the three strains to be independent, 0.99 x 0.99 x 0.99=0.97)|ANCOVA|0.67|||||ONE_SIDED|95.0|0.67||||||||||0.67|
72611442|NCT01773928|144751435|SUPERIORITY_OR_OTHER_LEGACY||ANCOVA|0.67|||||TWO_SIDED|95.0|0.67|1.5||||||"The overall power to prove the similarity between the three lots for all three strains is approximately 99%.~For the two primary co-analyses (Noninferiority and Lot Consistency), the overall power of the immunogenicity analyses is approximately 96% (calculated as 0.97 x 0.99=0.96)."||1.5|0.67|
72611443|NCT01773928|144751436|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|"Differences between fever incidences (95% CI) between treatment groups VCIV Modified (Total) and TIV was computed for each age cohort separately. The Confidence Interval estimation method was the method of Miettinen \& Nurminen, as described in the StatXact User Manual (i.e. the score statistics, also called Chan's method, page 283).~Noninferiority will be concluded if the upper limit of the 95% CI (VCIV modified-TIV) is \<5%."|Method of Miettinen & Nurminen|1.8||||||95.0|0.1|3.3||||||||3.3|0.1|
72611444|NCT02431299|144751447|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED|||||Whether there were significant changes in the IMRS baseline scores to IMRS follow up scores.|t-test, 2 sided|t = 2.78, df = 182||||||<0.01
72611445|NCT02431299|144751448|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Regression, Linear|||Hypothesized that higher levels of IMR competence would predict higher IMRS outcomes.||||<0.05
72611446|NCT03427892|144751478|OTHER|Within subjects design; single group. Intent-to-treat (ITT) sample was used in the analysis, such that all participants who completed the baseline visit and at least one post-baseline assessment were included in the analysis.|||||<|0.001||||||To analyze mood symptoms, cognitive performance, and side effects, separate one-way repeated measures analyses of variance (ANVOA) were performed. Time (bsl, wk 4, and wk 8) was included as the within-subject factor.|ANOVA|One-way repeated measures analyses of variance (ANVOA) were performed. Time (bsl, wk 4, wk8) was included as the within-subject factor.||Primary Aim is to determine if brexpiprazole is associated with a reduction in depressive symptom severity in bipolar disorder outpatients. A sample size of 17 provides 80% power for a paired t-test to compare baseline to exit change scores on the MADRS of 7 (SD 10) (a more conservative change than with even the low 1 mg dose of brexpiprazole in Thase et. al. (2015)) with alpha=.05. A sample size of n=20 will allow for some early withdrawals without postbaseline data (10).||||<.001
72611447|NCT03427892|144751479|OTHER|Within subjects design; single group. Intent-to-treat (ITT) sample was used in the analysis, such that all participants who completed the baseline visit and at least one post-baseline assessment were included in the analysis.||||||0.93||||||To analyze mood symptoms, cognitive performance, and side effects, separate one-way repeated measures analyses of variance (ANVOA) were performed. Time (bsl, wk 4, and wk 8) was included as the within-subject factor.|ANOVA|One-way repeated measures analyses of variance (ANVOA) were performed. Time (bsl, wk 4, wk8) was included as the within-subject factor.||Primary Aim is to determine if brexpiprazole is associated with a reduction in depressive symptom severity in bipolar disorder outpatients. A sample size of 17 provides 80% power for a paired t-test to compare baseline to exit change scores on the MADRS of 7 (SD 10) (a more conservative change than with even the low 1 mg dose of brexpiprazole in Thase et. al. (2015)) with alpha=.05. A sample size of n=20 will allow for some early withdrawals without postbaseline data (10).||||.93
72418708|NCT03387579|144347681|SUPERIORITY||estimate|11.162||||0.379|TWO_SIDED||||||Mixed Models Analysis|Intralipid 20% reduction versus smoflipid 20%|standard error 12.626|||||0.379
72418709|NCT03387579|144347681|SUPERIORITY||estimate|3.853||||0.717|TWO_SIDED|||||Intralipid 20% historic versus smoflipid 20%|Mixed Models Analysis||standard error 10.615|||||0.717
72418710|NCT03387579|144347681|SUPERIORITY|Intralipid 20% historic versus intralipid 20% reduction|estimate|-7.31||||0.576|TWO_SIDED||||||Mixed Models Analysis||standard error 13.025|||||0.576
72418711|NCT03387579|144347682|SUPERIORITY|||||||1|||||||Fisher Exact|||ROP||||1.00
72611448|NCT03427892|144751480|OTHER|Within subjects design; single group. Intent-to-treat (ITT) sample was used in the analysis, such that all participants who completed the baseline visit and at least one post-baseline assessment were included in the analysis.||||||0.49||||||To analyze mood symptoms, cognitive performance, and side effects, separate one-way repeated measures analyses of variance (ANVOA) were performed. Time (bsl, wk 4, and wk 8) was included as the within-subject factor. The above reported is RAVLT Score|ANOVA|One-way repeated measures analyses of variance (ANVOA) were performed. Time (bsl, wk 4, wk8) was included as the within-subject factor.||Primary Aim is to determine if brexpiprazole is associated with a reduction in depressive symptom severity in bipolar disorder outpatients. A sample size of 17 provides 80% power for a paired t-test to compare baseline to exit change scores on the MADRS of 7 (SD 10) (a more conservative change than with even the low 1 mg dose of brexpiprazole in Thase et. al. (2015)) with alpha=.05. A sample size of n=20 will allow for some early withdrawals without postbaseline data (10).||||.49
72611449|NCT03427892|144751480|OTHER|Within subjects design; single group. Intent-to-treat (ITT) sample was used in the analysis, such that all participants who completed the baseline visit and at least one post-baseline assessment were included in the analysis.||||||0.56||||||Within subjects design; single group. Intent-to-treat (ITT) sample was used in the analysis, such that all participants who completed the baseline visit and at least one post-baseline assessment were included in the analysis.Reported is delay score|ANOVA|One-way repeated measures analyses of variance (ANVOA) were performed. Time (bsl, wk 4, wk8) was included as the within-subject factor.||Primary Aim is to determine if brexpiprazole is associated with a reduction in depressive symptom severity in bipolar disorder outpatients. A sample size of 17 provides 80% power for a paired t-test to compare baseline to exit change scores on the MADRS of 7 (SD 10) (a more conservative change than with even the low 1 mg dose of brexpiprazole in Thase et. al. (2015)) with alpha=.05. A sample size of n=20 will allow for some early withdrawals without postbaseline data (10).||||.56
72611450|NCT03427892|144751481|OTHER|Within subjects design; single group. Intent-to-treat (ITT) sample was used in the analysis, such that all participants who completed the baseline visit and at least one post-baseline assessment were included in the analysis.||||||0.221||||||To analyze mood symptoms, cognitive performance, and side effects, separate one-way repeated measures analyses of variance (ANVOA) were performed. Time (bsl, wk 4, and wk 8) was included as the within-subject factor. Reported is CW score.|ANOVA|One-way repeated measures analyses of variance (ANVOA) were performed. Time (bsl, wk 4, wk8) was included as the within-subject factor.||Primary Aim is to determine if brexpiprazole is associated with a reduction in depressive symptom severity in bipolar disorder outpatients. A sample size of 17 provides 80% power for a paired t-test to compare baseline to exit change scores on the MADRS of 7 (SD 10) (a more conservative change than with even the low 1 mg dose of brexpiprazole in Thase et. al. (2015)) with alpha=.05. A sample size of n=20 will allow for some early withdrawals without postbaseline data (10).||||.221
72418712|NCT03387579|144347682|SUPERIORITY|||||||1|||||||Fisher Exact|||ROP||||1.00
72418713|NCT03387579|144347683|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.00
72326411|NCT01475721|144176026|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.687||||0.075|TWO_SIDED|95.0|0.454|1.04|||Regression, Cox||Analysis of number of asthma exacerbations in efficacy subgroup: Subjects controlled on prior ICS therapy|The hazard ratio computed is essentially the relative risk of having the event in the treatment group relative to the control group, adjusted for time to the event.||1.040|0.454|0.075
72326412|NCT01475721|144176028|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.776||||0.123|TWO_SIDED|95.0|0.562|1.071|||Regression, Cox|||||1.071|0.562|0.123
72326413|NCT01475721|144176029|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.263|||<|0.001|TWO_SIDED|95.0|-0.385|-0.141|||Regression, Cox||Efficacy subgroup: Subjects not well-controlled on prior ICS or non-LABA therapy|||-0.141|-0.385|<0.001
72326414|NCT01475721|144176029|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.222||||0.003|TWO_SIDED|95.0|-0.369|-0.076|||Regression, Cox||Efficacy subgroup: Subjects not well-controlled on prior ICS+LABA therapy|||-0.076|-0.369|0.003
72326415|NCT01475721|144176029|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.172|||<|0.001|TWO_SIDED|95.0|-0.238|-0.106|||Regression, Cox||Efficacy subgroup: Subjects controlled on prior ICS+LABA therapy|||-0.106|-0.238|<0.001
72326416|NCT01475721|144176029|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.08||||0.251|TWO_SIDED|95.0|-0.216|0.056|||Regression, Cox||Efficacy subgroup: Subjects controlled on prior ICS therapy|||0.056|-0.216|0.251
72418714|NCT03387579|144347683|SUPERIORITY|||||||0.64|||||||Fisher Exact|||||||0.640
72326417|NCT04343092|144176031|SUPERIORITY||Mean Difference (Final Values)|7.92||||0.05|TWO_SIDED||||||t-test, 2 sided||||Historical control population included: Hydroxychloroquin (HCQ) 400mg BID at admission day then 200mg BID for 5 days plus Azithromycin (AZT) 500mg at admission day then 250mg for 5 days.|||0.05
72326418|NCT00803738|144176032|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|For the primary clinical equivalence analysis, a 90% confidence interval was constructed on the difference in the therapeutic cure rates between the Test Product and Reference Product at the Test-of-Cure visit (Visit 3). The interval was calculated using Wald's method with Yates' continuity correction. Clinical equivalence was established if this 90% confidence interval was contained within the interval -0.20 to +0.20 (-20% to +20%).|proportion of subjects in trtmt groups|0.05|||||TWO_SIDED|90.0|-4.3|15.02|||Wald's method with Yates' continuity|||||15.02|-4.30|
72326419|NCT00803738|144176033|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|A 90% confidence interval was constructed on the difference in the mycological cure rates between the Test Product and Reference Product at the Test-of-Cure visit (Visit 3). The interval was calculated using Wald's method with Yates' continuity correction. Clinical equivalence was established if this 90% confidence interval was contained within the interval -0.20 to +0.20 (-20% to +20%).|proportion of subjects in trtmt groups|0.05|||||TWO_SIDED|90.0|-4.66|11.49|||Wald's method with Yates' continuity|||||11.49|-4.66|
72326420|NCT00803738|144176034|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|A 90% confidence interval was constructed on the difference in the clinical cure rates between the Test Product and Reference Product at the Test-of-Cure visit (Visit 3). The interval was calculated using Wald's method with Yates' continuity correction. Clinical equivalence was established if this 90% confidence interval was contained within the interval -0.20 to +0.20 (-20% to +20%).|proportion of subjects in trtmt groups|0.05|||||TWO_SIDED|90.0|-1.35|16.88|||Wald's method with Yates' continuity|||||16.88|-1.35|
72418715|NCT03387579|144347683|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.00
72418716|NCT03387579|144347684|SUPERIORITY|||||||0.211|||||||Kruskal-Wallis|||||||0.211
72418717|NCT03387579|144347685|SUPERIORITY|||||||0.72|||||||Wilcoxon (Mann-Whitney)|||||||0.720
72418718|NCT03387579|144347686|SUPERIORITY|||||||0.5|||||||Wilcoxon (Mann-Whitney)|||||||0.500
72611451|NCT03427892|144751481|OTHER|Within subjects design; single group. Intent-to-treat (ITT) sample was used in the analysis, such that all participants who completed the baseline visit and at least one post-baseline assessment were included in the analysis.||||||0.306||||||To analyze mood symptoms, cognitive performance, and side effects, separate one-way repeated measures analyses of variance (ANVOA) were performed. Time (bsl, wk 4, and wk 8) was included as the within-subject factor.Reported is Inter. score|ANOVA|One-way repeated measures analyses of variance (ANVOA) were performed. Time (bsl, wk 4, wk8) was included as the within-subject factor.||Primary Aim is to determine if brexpiprazole is associated with a reduction in depressive symptom severity in bipolar disorder outpatients. A sample size of 17 provides 80% power for a paired t-test to compare baseline to exit change scores on the MADRS of 7 (SD 10) (a more conservative change than with even the low 1 mg dose of brexpiprazole in Thase et. al. (2015)) with alpha=.05. A sample size of n=20 will allow for some early withdrawals without postbaseline data (10).||||.306
72326421|NCT03856359|144176078|SUPERIORITY|||||||0.6|||||||t-test, 2 sided|||||||0.60
72326422|NCT03856359|144176080|SUPERIORITY|||||||0.67|||||||t-test, 2 sided|||||||0.67
72326423|NCT03856359|144176082|SUPERIORITY|||||||0.73|||||||t-test, 2 sided|||||||0.73
72326424|NCT03856359|144176084|SUPERIORITY|||||||0.38|||||||t-test, 2 sided|||||||0.38
72326425|NCT03856359|144176085|SUPERIORITY|||||||0.23|||||||t-test, 2 sided|||||||0.23
72418719|NCT03387579|144347687|SUPERIORITY|||||||0.774|||||||t-test, 2 sided|||||||0.774
72418720|NCT03387579|144347688|SUPERIORITY|||||||0.457|||||||Wilcoxon (Mann-Whitney)|||||||0.457
72326426|NCT03856359|144176086|SUPERIORITY|||||||0.17|||||||t-test, 2 sided|||||||0.17
72326427|NCT03856359|144176087|SUPERIORITY|||||||0.004|||||||t-test, 2 sided|||||||0.004
72326428|NCT03856359|144176088|SUPERIORITY|||||||0.7|||||||t-test, 2 sided|||||||0.7
72326429|NCT03856359|144176089|SUPERIORITY|||||||0.09|||||||t-test, 2 sided|||||||0.09
72326430|NCT03856359|144176090|SUPERIORITY|||||||0.65|||||||t-test, 2 sided|||||||0.65
72326431|NCT03856359|144176091|SUPERIORITY|||||||0.18|||||||t-test, 2 sided|||||||0.18
72326432|NCT03856359|144176092|SUPERIORITY|||||||0.44|||||||t-test, 2 sided|||||||0.44
72326433|NCT03856359|144176093|SUPERIORITY|||||||0.2|||||||t-test, 2 sided|||||||0.20
72326434|NCT03856359|144176094|SUPERIORITY|||||||0.53|||||||t-test, 2 sided|||||||0.53
72326435|NCT03856359|144176095|SUPERIORITY|||||||0.07|||||||t-test, 2 sided|||||||0.07
72326436|NCT03856359|144176096|SUPERIORITY|||||||0.36|||||||t-test, 2 sided|||||||0.36
72326437|NCT00589797|144176114|NON_INFERIORITY|The trial was designed as a non-inferiority trial with a margin (delta) of 15%. Additional analyses using a delta of 10% as requested by FDA were also conducted.|||||<|0.05|TWO_SIDED|95.0|||||t-test, 1 sided|||||||<0.05
72326438|NCT01881009|144176123|SUPERIORITY_OR_OTHER_LEGACY|||||||0.004|||||||Wilcoxon (Mann-Whitney)|||||||0.004
72326439|NCT01881009|144176124|OTHER|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||||||0.001
72326440|NCT02141672|144176126|SUPERIORITY||Odds Ratio (OR)|2.03||||0.045|TWO_SIDED|95.0|1.01|4.05|||Regression, Logistic|||Voclosporin low dose vs. placebo||4.05|1.01|0.045
72326441|NCT02141672|144176126|SUPERIORITY||Odds Ratio (OR)|1.59||||0.204|TWO_SIDED|95.0|0.78|3.27|||Regression, Logistic|||Voclosporin high dose vs. placebo||3.27|0.78|0.204
72326442|NCT02141672|144176127|SUPERIORITY||Odds Ratio (OR)|3.21|||<|0.001|TWO_SIDED|95.0|1.68|6.13|||Regression, Logistic|||Voclosporin low dose vs. placebo||6.13|1.68|<0.001
72326443|NCT02141672|144176127|SUPERIORITY||Odds Ratio (OR)|2.1||||0.026|TWO_SIDED|95.0|1.09|4.02|||Regression, Logistic|||Voclosporin high dose vs. placebo||4.02|1.09|0.026
72326444|NCT02141672|144176128|SUPERIORITY||Odds Ratio (OR)|1.9||||0.066|TWO_SIDED|95.0|0.96|3.78|||Regression, Logistic|||||3.78|0.96|0.066
72326445|NCT02141672|144176128|SUPERIORITY||Odds Ratio (OR)|1.64||||0.162|TWO_SIDED|95.0|0.82|3.28|||Regression, Logistic|||||3.28|0.82|0.162
72326446|NCT02141672|144176129|SUPERIORITY||Hazard Ratio (HR)|2.26|||<|0.001|TWO_SIDED|95.0|1.45|3.51|||Regression, Cox|||Voclosporin low dose vs. placebo||3.51|1.45|<0.001
72326447|NCT02141672|144176129|SUPERIORITY||Hazard Ratio (HR)|2.25|||<|0.001|TWO_SIDED|95.0|1.46|3.47|||Regression, Cox|||Voclosporin high dose vs. placebo||3.47|1.46|<0.001
72326448|NCT02141672|144176130|SUPERIORITY||Hazard Ratio (HR)|2.89|||<|0.001|TWO_SIDED|95.0|1.58|5.29|||Regression, Cox|||||5.29|1.58|<0.001
72326449|NCT02141672|144176130|SUPERIORITY||Hazard Ratio (HR)|1.48|||<|0.248|TWO_SIDED|95.0|0.77|2.86|||Regression, Cox|||Voclosporin high dose vs. placebo||2.86|0.77|<0.248
72326450|NCT02141672|144176132|SUPERIORITY||Hazard Ratio (HR)|1.63||||0.005|TWO_SIDED|95.0|1.16|2.27|||Regression, Cox|||||2.27|1.16|0.005
72326451|NCT02141672|144176132|SUPERIORITY||Hazard Ratio (HR)|1.74||||0.002|TWO_SIDED|95.0|1.25|2.43|||Regression, Cox|||Voclosporin high dose vs. placebo||2.43|1.25|0.002
72326452|NCT02141672|144176134|SUPERIORITY||Hazard Ratio (HR)|0.99||||0.98|TWO_SIDED|95.0|0.45|2.15|||Regression, Cox|||Voclosporin low dose vs. placebo||2.15|0.45|0.980
72326453|NCT02141672|144176134|SUPERIORITY||Hazard Ratio (HR)|1.98||||0.118|TWO_SIDED|95.0|0.95|4.16|||Regression, Cox|||Voclosporin high dose vs. placebo||4.16|0.95|0.118
72326454|NCT02141672|144176136|SUPERIORITY||Odds Ratio (OR)|2.33||||0.007|TWO_SIDED|95.0|1.26|4.33|||Regression, Logistic|||week 24||4.33|1.26|0.007
72326455|NCT02141672|144176136|SUPERIORITY||Odds Ratio (OR)|2.03||||0.024|TWO_SIDED|95.0|1.1|3.76|||Regression, Logistic|||week 24||3.76|1.1|0.024
72326456|NCT02141672|144176136|SUPERIORITY||Odds Ratio (OR)|2.34||||0.007|TWO_SIDED|95.0|1.27|4.33|||Regression, Logistic|||week 48||4.33|1.27|0.007
72326457|NCT02141672|144176136|SUPERIORITY||Odds Ratio (OR)|2.68||||0.002|TWO_SIDED|95.0|1.43|5.02|||Regression, Logistic|||week 48||5.02|1.43|0.002
72418721|NCT03387579|144347689|SUPERIORITY|||||||0.475|||||||Wilcoxon (Mann-Whitney)|||||||0.475
72418722|NCT04020341|144347715|NON_INFERIORITY|The difference in success rate between treatment groups (gepotidacin - nitrofurantoin) was calculated using Miettinen-Nurminen Summary Score Method adjusted for age group and acute cystitis recurrence strata combinations. Criteria for non-inferiority is if the Z-statistic for non-inferiority is greater than the Z-statistic boundary (2.065).|Adjusted Difference in Percent|4.3|||||TWO_SIDED|95.0|-3.6|12.1|||||||Observed Z statistic value for Noninferiority was 3.5554.|12.1|-3.6|
72611452|NCT03427892|144751482|OTHER|Within subjects design; single group. Intent-to-treat (ITT) sample was used in the analysis, such that all participants who completed the baseline visit and at least one post-baseline assessment were included in the analysis.||||||0.07||||||To analyze mood symptoms, cognitive performance, and side effects, separate one-way repeated measures analyses of variance (ANVOA) were performed. Time (bsl, wk 4, and wk 8) was included as the within-subject factor. The above reported is TMT A.|ANOVA|One-way repeated measures analyses of variance (ANVOA) were performed. Time (bsl, wk 4, wk8) was included as the within-subject factor.||Primary Aim is to determine if brexpiprazole is associated with a reduction in depressive symptom severity in bipolar disorder outpatients. A sample size of 17 provides 80% power for a paired t-test to compare baseline to exit change scores on the MADRS of 7 (SD 10) (a more conservative change than with even the low 1 mg dose of brexpiprazole in Thase et. al. (2015)) with alpha=.05. A sample size of n=20 will allow for some early withdrawals without postbaseline data (10).||||.07
72326458|NCT02141672|144176137|SUPERIORITY||Hazard Ratio (HR)|2.03|||<|0.001|TWO_SIDED|95.0|1.36|3.03|||Regression, Cox|||Voclosporin low dose vs. placebo||3.03|1.36|<0.001
72418723|NCT04020341|144347715|SUPERIORITY|The difference in success rate between treatment groups (gepotidacin - nitrofurantoin) was calculated using Miettinen-Nurminen Summary Score Method adjusted for age group and acute cystitis recurrence strata combinations. Criteria for superiority is if the one-sided p-value is less than the 0.019 p-value boundary.|Adjusted difference of Percent|4.3||||0.1445|TWO_SIDED|95.0|-3.6|12.1|||1-sided p-value for Test of Superiority|||||12.1|-3.6|0.1445
72326459|NCT02141672|144176137|SUPERIORITY||Hazard Ratio (HR)|1.81||||0.004|TWO_SIDED|95.0|1.22|2.69|||Regression, Cox|||Voclosporin high dose vs. placebo||2.69|1.22|0.004
72326460|NCT02141672|144176139|SUPERIORITY||Hazard Ratio (HR)|2.21|||<|0.001|TWO_SIDED|95.0|1.45|3.36|||Regression, Cox|||Voclosporin low dose vs. placebo||3.36|1.45|<0.001
72326461|NCT02141672|144176139|SUPERIORITY||Hazard Ratio (HR)|1.87||||0.004|TWO_SIDED|95.0|1.23|2.84|||Regression, Cox|||Voclosporin high dose vs. placebo||2.84|1.23|0.004
72326462|NCT01061385|144176146|SUPERIORITY_OR_OTHER||Mean Difference (Net)|7.5||||0.2922|TWO_SIDED|95.0|-6.8|21.7|||t-test, 1 sided|||||21.7|-6.8|0.2922
72326463|NCT01061385|144176147|SUPERIORITY_OR_OTHER||Mean Difference (Net)|5.0|||||TWO_SIDED|95.0|-37.7|38.0|||||The 95% CI range above is calculated for the current estimated value.|||38.0|-37.7|
72326464|NCT00533429|144176148|SUPERIORITY_OR_OTHER_LEGACY|||||||0.469||||||P-value (one-tailed) was calculated based on the un-stratified log-rank test.|Log Rank|||||||0.469
72418724|NCT04683926|144347751|OTHER||AUC(0-36) Estimate (β1)|1.0227|||||TWO_SIDED|||||||||Analysis of dose proportionality following 10, 20 and 30 mg fasted using a mixed-effects model based on a power function: ln(dependent variable) = β1×ln(Dose) + ln(β0) + ε. Random slope and intercept. 90% CI of β1 acceptance range of 0.8-1.25 modified to account for ratio of dose levels in this study as follows: \[1+ln(0.8)/ln(3), 1+ln(1.25)/ln(3)\], giving acceptance range of \[0.7969, 1.2031\]. If the 90% CI of β1 is within \[0.7969, 1.2031\], dose-proportionality is proven for the PK parameter.||||
72418725|NCT04683926|144347751|OTHER||AUC(inf) Estimate (β1)|1.0223|||||TWO_SIDED|||||||||Analysis of dose proportionality following 10, 20 and 30 mg fasted using a mixed-effects model based on a power function: ln(dependent variable) = β1×ln(Dose) + ln(β0) + ε. Random slope and intercept. 90% CI of β1 acceptance range of 0.8-1.25 modified to account for ratio of dose levels in this study as follows: \[1+ln(0.8)/ln(3), 1+ln(1.25)/ln(3)\], giving acceptance range of \[0.7969, 1.2031\]. If the 90% CI of β1 is within \[0.7969, 1.2031\], dose-proportionality is proven for the PK parameter.||||
72418726|NCT04683926|144347751|EQUIVALENCE|Absent food effect will be established if the 90% CI for the ratio of population geometric means between fed and fasted 30 mg doses, based on log-transformed data, is contained in the equivalence limits of 0.80-1.25 for AUC0-inf and Cmax.|AUC(0-inf) fed/fasted ratio|1.09|||||TWO_SIDED|90.0|1.05|1.12||||||Analysis of food effect on desmetramadol in the evaluable population using natural logarithm-transformed PK exposure parameters of desmetramadol enantiomers following administration of 30 mg desmetramadol in the fed and fasted states.||1.12|1.05|
72418727|NCT04683926|144347752|OTHER||Cmax Estimate (β1)|0.9899|||||TWO_SIDED|||||||||Analysis of dose proportionality following 10, 20 and 30 mg fasted using a mixed-effects model based on a power function: ln(dependent variable) = β1×ln(Dose) + ln(β0) + ε. Random slope and intercept. 90% CI of β1 acceptance range of 0.8-1.25 modified to account for ratio of dose levels in this study as follows: \[1+ln(0.8)/ln(3), 1+ln(1.25)/ln(3)\], giving acceptance range of \[0.7969, 1.2031\]. If the 90% CI of β1 is within \[0.7969, 1.2031\], dose-proportionality is proven for the PK parameter.||||
72418728|NCT04683926|144347752|EQUIVALENCE|Absent food effect will be established if the 90% CI for the ratio of population geometric means between fed and fasted 30 mg doses, based on log-transformed data, is contained in the equivalence limits of 0.80-1.25 for AUC0-inf and Cmax.|Cmax 90% fed/fasted ratio|1.18|||||TWO_SIDED|90.0|1.08|1.28||||||Analysis of food effect on desmetramadol in the evaluable population using natural logarithm-transformed PK exposure parameters of desmetramadol enantiomers following administration of 30 mg desmetramadol in the fed and fasted states.||1.28|1.08|
72418729|NCT00716092|144347764|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.9|STANDARD_ERROR_OF_MEAN|4.0|<|0.0001||95.0|-28.0|-11.9||There was no adjustment for multiple primary endpoints, however a hierarchy approach to control for the Type-I error was used. If the endpoint WMG was not successful, any analysis of the GLP-1 (AUEC 0-24h) was to be considered descriptive.|ANCOVA|The primary analyses are based upon a model containing only BI1356 and Placebo. Sitagliptin values come from a different model containing all 3 groups||BI1356 minus Placebo||-11.9|-28.0|<0.0001
72418730|NCT00716092|144347765|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|18.1|STANDARD_ERROR_OF_MEAN|2.9|<|0.0001||95.0|12.4|23.9||There was no adjustment for multiple primary endpoints, however a hierarchy approach to control for the Type-I error was used. If the endpoint WMG was not successful, any analysis of the GLP-1 (AUEC 0-24h) will be considered descriptive.|ANCOVA|The primary analyses are based upon a model containing only BI1356 and Placebo. Sitagliptin values come from a different model containing all 3 groups||BI1356 minus Placebo||23.9|12.4|<0.0001
72418731|NCT00716092|144347766|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.8|STANDARD_ERROR_OF_MEAN|4.8||0.0283||95.0|-20.4|-1.2|||ANCOVA|The primary analyses are based upon a model containing only BI1356 and Placebo. Sitagliptin values come from a different model containing all 3 groups||BI1356 minus Placebo||-1.2|-20.4|0.0283
72418732|NCT00716092|144347767|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-106.5|STANDARD_ERROR_OF_MEAN|20.3|<|0.0001||95.0|-147.0|-66.0|||ANCOVA|The primary analyses are based upon a model containing only BI1356 and Placebo. Sitagliptin values come from a different model containing all 3 groups||BI1356 minus Placebo||-66.0|-147.0|<0.0001
72418733|NCT00716092|144347768|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.0|STANDARD_ERROR_OF_MEAN|3.9||0.1274||95.0|-1.7|13.8|||ANCOVA|These measured values and statistical analysis come from a mixed model containing all three treatment groups, and adjusted as already described.||BI 1356 minus Sitagliptin. This analysis comparing BI1356 to Sitagliptin was conducted as an exploratory analysis at the time of analysing the study data. The study was not powered for such a comparison.||13.8|-1.7|0.1274
72418734|NCT00716092|144347769|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.8|STANDARD_ERROR_OF_MEAN|2.7||0.313||95.0|-2.7|8.2|||ANCOVA|These measured values and statistical analysis come from a mixed model containing all three treatment groups, and adjusted as already described.||BI 1356 minus Sitagliptin. This analysis comparing BI1356 to Sitagliptin was conducted as an exploratory analysis at the time of analysing the study data. The study was not powered for such a comparison.||8.2|-2.7|0.3130
72418735|NCT00716092|144347770|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.2|STANDARD_ERROR_OF_MEAN|4.3||0.2281||95.0|-3.3|13.8|||ANCOVA|These measured values and statistical analysis come from a mixed model containing all three treatment groups, and adjusted as already described.||BI 1356 minus Sitagliptin. This analysis comparing BI1356 to Sitagliptin was conducted as an exploratory analysis at the time of analysing the study data. The study was not powered for such a comparison.||13.8|-3.3|0.2281
72418736|NCT00716092|144347771|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|22.7|STANDARD_ERROR_OF_MEAN|18.6||0.223||95.0|-14.0|59.5|||ANCOVA|These measured values and statistical analysis come from a mixed model containing all three treatment groups, and adjusted as already described.||BI 1356 minus Sitagliptin. This analysis comparing BI1356 to Sitagliptin was conducted as an exploratory analysis at the time of analysing the study data. The study was not powered for such a comparison.||59.5|-14.0|0.2230
72326465|NCT00533429|144176149|SUPERIORITY_OR_OTHER_LEGACY|||||||0.462||||||95% confidence interval based on normal approximation to the binomial distribution. P-value (2-tailed) calculation based on unadjusted, normal-distribution approximation for the difference in rates.|Fisher Exact|||||||0.462
72326466|NCT00533429|144176150|SUPERIORITY_OR_OTHER_LEGACY|||||||0.492||||||P-value (two-tailed) was calculated based on the un-stratified log-rank test.|Log Rank|||||||0.492
72326467|NCT03800030|144176168|SUPERIORITY|||||||0.031|||||||t-test, 2 sided|degrees of freedom = 22 t-statistic = 2.305||||||0.031
72326468|NCT03800030|144176169|SUPERIORITY|||||||0.935|||||||t-test, 2 sided|degrees of freedom = 22 t-statistic = 0.083||||||0.935
72326469|NCT03800030|144176170|SUPERIORITY|||||||0.04|||||||t-test, 1 sided|degrees of freedom = 22 t-statistic = 1.833||||||0.040
72326470|NCT03800030|144176171|SUPERIORITY|||||||0.02|||||||t-test, 1 sided|degrees of freedom = 22 t-statistic = 2.174||||||0.020
72326471|NCT03800030|144176172|SUPERIORITY|||||||0.54|||||||t-test, 2 sided|degrees of freedom = 22 t-statistic = -0.623||||||0.540
72326472|NCT03800030|144176173|SUPERIORITY|||||||0.007|||||||t-test, 2 sided|degrees of freedom = 22 t-statistic = 2.989||||||0.007
72326473|NCT02230189|144176174|SUPERIORITY||Mean Difference (Net)|2.11||||0.01|TWO_SIDED||||||t-test, 2 sided|||miR4521||||0.010
72326474|NCT02230189|144176174|SUPERIORITY||Mean Difference (Net)|0.56||||0.01|TWO_SIDED||||||t-test, 2 sided|||miR107||||0.010
72326475|NCT02230189|144176174|SUPERIORITY||Mean Difference (Net)|2.57||||0.018|TWO_SIDED||||||t-test, 2 sided|||miR-891a||||0.018
72326476|NCT02230189|144176174|SUPERIORITY||Mean Difference (Net)|0.88||||0.021|TWO_SIDED||||||t-test, 2 sided|||miR363||||0.021
72326477|NCT02230189|144176174|SUPERIORITY||Mean Difference (Net)|-1.0||||0.028|TWO_SIDED||||||t-test, 2 sided|||miR1248||||0.028
72326478|NCT02230189|144176174|SUPERIORITY||Mean Difference (Net)|-0.85||||0.033|TWO_SIDED||||||t-test, 2 sided|||miR944||||0.033
72326479|NCT02230189|144176174|SUPERIORITY||Mean Difference (Net)|2.13||||0.034|TWO_SIDED||||||t-test, 2 sided|||miR6806||||0.034
72326480|NCT02230189|144176174|SUPERIORITY||Mean Difference (Net)|0.39||||0.036|TWO_SIDED||||||t-test, 2 sided|||miR103a||||0.036
72326481|NCT02230189|144176174|SUPERIORITY||Mean Difference (Net)|1.69||||0.037|TWO_SIDED||||||t-test, 2 sided|||miR454||||0.037
72326482|NCT02230189|144176174|SUPERIORITY||Mean Difference (Net)|-1.13||||0.041|TWO_SIDED||||||t-test, 2 sided|||miR320e||||0.041
72326483|NCT02230189|144176174|SUPERIORITY||Mean Difference (Net)|-0.55||||0.043|TWO_SIDED||||||t-test, 2 sided|||miR181a||||0.043
72326484|NCT02230189|144176174|SUPERIORITY||Mean Difference (Net)|1.95||||0.044|TWO_SIDED||||||t-test, 2 sided|||miR130b||||0.044
72326485|NCT02230189|144176174|SUPERIORITY||Mean Difference (Net)|-2.18||||0.044|TWO_SIDED||||||t-test, 2 sided|||miR365a||||0.044
72326486|NCT02230189|144176174|SUPERIORITY||Mean Difference (Net)|2.06||||0.047|TWO_SIDED||||||t-test, 2 sided|||miR135b||||0.047
72326487|NCT02230189|144176174|SUPERIORITY||Mean Difference (Net)|-2.35||||0.048|TWO_SIDED||||||t-test, 2 sided|||miR1273h||||0.048
72326488|NCT02230189|144176174|SUPERIORITY||Mean Difference (Net)|-1.31||||0.048|TWO_SIDED||||||t-test, 2 sided|||miR3177||||0.048
72326489|NCT02230189|144176175|SUPERIORITY||Mean Difference (Net)|-1.83||||0|TWO_SIDED||||||t-test, 2 sided|||miR6510||||0.0
72326490|NCT02230189|144176175|SUPERIORITY||Mean Difference (Net)|-2.09||||0|TWO_SIDED||||||t-test, 2 sided|||miR3605||||0
72326491|NCT02230189|144176175|SUPERIORITY||Mean Difference (Net)|-5.75||||0|TWO_SIDED||||||t-test, 2 sided|||miR3912||||0
72326492|NCT02230189|144176175|SUPERIORITY||Median Difference (Net)|1.93||||0|TWO_SIDED||||||t-test, 2 sided|||miR15b||||0
72326493|NCT02230189|144176175|SUPERIORITY||Mean Difference (Net)|-2.35||||0|TWO_SIDED||||||t-test, 2 sided|||miR127||||0
72326494|NCT02230189|144176175|SUPERIORITY||Mean Difference (Net)|1.59||||0|TWO_SIDED||||||t-test, 2 sided|||miR146a||||0
72326495|NCT02230189|144176175|SUPERIORITY||Mean Difference (Net)|1.21||||0|TWO_SIDED||||||t-test, 2 sided|||miR449b||||0
72326496|NCT02230189|144176175|SUPERIORITY||Mean Difference (Net)|0.85||||0.01|TWO_SIDED||||||t-test, 2 sided|||miR21-5p||||0.01
72326497|NCT02230189|144176175|SUPERIORITY||Mean Difference (Net)|-1.29||||0.01|TWO_SIDED||||||t-test, 2 sided|||miR6842||||0.01
72326498|NCT02230189|144176175|SUPERIORITY||Mean Difference (Net)|1.24||||0.01|TWO_SIDED||||||t-test, 2 sided|||miR142-5p||||0.01
72326499|NCT02230189|144176175|SUPERIORITY||Mean Difference (Net)|1.67||||0.01|TWO_SIDED||||||t-test, 2 sided|||miR21||||0.01
72326500|NCT02230189|144176175|SUPERIORITY||Mean Difference (Net)|-4.24||||0.01|TWO_SIDED||||||t-test, 2 sided|||miR493||||0.01
72326501|NCT02230189|144176175|SUPERIORITY||Mean Difference (Net)|-1.46||||0.01|TWO_SIDED||||||t-test, 2 sided|||miR193a||||0.01
72326502|NCT02230189|144176175|SUPERIORITY||Mean Difference (Net)|-0.89||||0.01|TWO_SIDED||||||t-test, 2 sided|||miR149||||0.01
72326503|NCT02230189|144176175|SUPERIORITY||Mean Difference (Net)|1.06||||0.01|TWO_SIDED||||||t-test, 2 sided|||miR449a||||0.01
72326504|NCT02230189|144176175|SUPERIORITY||Mean Difference (Net)|-2.1||||0.01|TWO_SIDED||||||t-test, 2 sided|||miR6511a||||0.01
72326505|NCT02230189|144176175|SUPERIORITY||Mean Difference (Net)|-1.59||||0.01|TWO_SIDED||||||t-test, 2 sided|||miR6843||||0.01
72326506|NCT02230189|144176175|SUPERIORITY||Mean Difference (Net)|-0.95||||0.01|TWO_SIDED||||||t-test, 2 sided|||miR671||||0.01
72326507|NCT02230189|144176175|SUPERIORITY||Mean Difference (Net)|-4.65||||0.02|TWO_SIDED||||||t-test, 2 sided|||miR6503||||0.02
72326508|NCT02230189|144176175|SUPERIORITY||Mean Difference (Net)|2.84||||0.02|TWO_SIDED||||||t-test, 2 sided|||miR450b||||0.02
72326509|NCT02230189|144176175|SUPERIORITY||Mean Difference (Net)|-4.92||||0.02|TWO_SIDED||||||t-test, 2 sided|||miR485||||0.02
72326510|NCT02230189|144176175|SUPERIORITY||Mean Difference (Net)|-2.49||||0.02|TWO_SIDED||||||t-test, 2 sided|||miR6806||||0.02
72326511|NCT02230189|144176175|SUPERIORITY||Mean Difference (Net)|2.18||||0.02|TWO_SIDED||||||t-test, 2 sided|||miR3182||||0.02
72326512|NCT02230189|144176175|SUPERIORITY||Mean Difference (Net)|1.28||||0.02|TWO_SIDED||||||t-test, 2 sided|||miR142-3p||||0.02
72326513|NCT02230189|144176175|SUPERIORITY||Mean Difference (Net)|-1.23||||0.02|TWO_SIDED||||||t-test, 2 sided|||miR320d||||0.02
72326514|NCT02230189|144176175|SUPERIORITY||Mean Difference (Net)|2.73||||0.02|TWO_SIDED||||||t-test, 2 sided|||miR3928||||0.02
72326515|NCT02230189|144176175|SUPERIORITY||Mean Difference (Net)|4.59||||0.02|TWO_SIDED||||||t-test, 2 sided|||miR744||||0.02
72326516|NCT02230189|144176175|SUPERIORITY||Median Difference (Net)|3.42||||0.02|TWO_SIDED||||||t-test, 2 sided|||miR206||||0.02
72326517|NCT02230189|144176175|SUPERIORITY||Mean Difference (Net)|0.9||||0.03|TWO_SIDED||||||t-test, 2 sided|||miR30e||||0.03
72326518|NCT02230189|144176175|SUPERIORITY||Mean Difference (Net)|1.52||||0.03|TWO_SIDED||||||t-test, 2 sided|||miR4500||||0.03
72326519|NCT02230189|144176175|SUPERIORITY||Mean Difference (Net)|-0.98||||0.03|TWO_SIDED||||||t-test, 2 sided|||miR125a||||0.03
72326520|NCT02230189|144176175|SUPERIORITY||Mean Difference (Net)|-0.6||||0.03|TWO_SIDED||||||t-test, 2 sided|||miR99b||||0.03
72326521|NCT02230189|144176175|SUPERIORITY||Mean Difference (Net)|2.67||||0.03|TWO_SIDED||||||t-test, 2 sided|||miR1||||0.03
72326522|NCT02230189|144176175|SUPERIORITY||Mean Difference (Net)|-0.77||||0.03|TWO_SIDED||||||t-test, 2 sided|||miR146b||||0.03
72326523|NCT02230189|144176175|SUPERIORITY||Mean Difference (Net)|-3.17||||0.03|TWO_SIDED||||||t-test, 2 sided|||miR1255a||||0.03
72418737|NCT00677235|144347781|SUPERIORITY_OR_OTHER|||||||0.449|||||||Fisher Exact|||||||0.449
72326524|NCT02230189|144176175|SUPERIORITY||Mean Difference (Net)|1.02||||0.03|TWO_SIDED||||||t-test, 2 sided|||miR223||||0.03
72326525|NCT02230189|144176175|SUPERIORITY||Mean Difference (Net)|-0.78||||0.03|TWO_SIDED||||||t-test, 2 sided|||miR642a||||0.03
72326526|NCT02230189|144176175|SUPERIORITY||Mean Difference (Net)|2.17||||0.4|TWO_SIDED||||||t-test, 2 sided|||miR548ae||||0.4
72326527|NCT02230189|144176175|SUPERIORITY||Mean Difference (Net)|-0.79||||0.04|TWO_SIDED||||||t-test, 2 sided|||miR146b||||0.04
72326528|NCT02230189|144176175|SUPERIORITY||Mean Difference (Net)|-2.52||||0.04|TWO_SIDED||||||t-test, 2 sided|||miR877||||0.04
72326529|NCT02230189|144176175|SUPERIORITY||Mean Difference (Net)|-0.69||||0.04|TWO_SIDED||||||t-test, 2 sided|||miR181a||||0.04
72326530|NCT02230189|144176175|SUPERIORITY||Mean Difference (Net)|-3.4||||0.04|TWO_SIDED||||||t-test, 2 sided|||miR4467||||0.04
72326531|NCT02230189|144176175|SUPERIORITY||Mean Difference (Net)|-2.48||||0.04|TWO_SIDED||||||t-test, 2 sided|||miR1249||||0.04
72326532|NCT02230189|144176175|SUPERIORITY||Mean Difference (Net)|3.87||||0.04|TWO_SIDED||||||t-test, 2 sided|||miR766||||0.04
72326533|NCT02230189|144176175|SUPERIORITY||Mean Difference (Net)|1.07||||0.048|TWO_SIDED||||||t-test, 2 sided|||miR29c||||0.048
72326534|NCT02230189|144176175|SUPERIORITY||Mean Difference (Net)|-1.75||||-1.75|TWO_SIDED||||||t-test, 2 sided|||miR370||||-1.75
72326535|NCT04389866|144176193|SUPERIORITY||Mean Difference (Final Values)|-0.357|STANDARD_DEVIATION|0.864||0.018|TWO_SIDED|||||The threshold for statistical significance was p = 0.05.|t-test, 2 sided|The df = 13 for arm 1 (jawline injections) analysis of Jawline Rating Scale Assessments given by blinded physician.|Treatment Difference = 4 Weeks after last injection - Baseline|The null hypothesis for the 7 participants placed randomly 1:1 in the jawline injection arm was that there would be no statistically significant change in the blinded physician Jawline Rating Scale Assessment at baseline versus four weeks after last injection.||||0.018
72326536|NCT04389866|144176193|SUPERIORITY||Mean Difference (Final Values)|-0.214|STANDARD_DEVIATION|0.864||0.082|TWO_SIDED|||||The threshold for statistical significance was p = 0.05.|t-test, 2 sided|The df = 13 for arm 2 (jawline and lateral zygomatic cheek area injections) analysis of Jawline Rating Scale Assessments given by blinded physician.|Treatment Difference = 4 Weeks after last injection - Baseline|The null hypothesis for the 7 participants placed randomly 1:1 in the jawline and lateral (zygomatic) cheek area injections arm was that there would be no statistically significant change in the blinded physician Jawline Rating Scale Assessment at baseline versus four weeks after last injection.||||0.082
72326537|NCT04389866|144176194|SUPERIORITY||Mean Difference (Final Values)|-1.0|STANDARD_DEVIATION|0.497||3.1e-07|TWO_SIDED|||||The threshold for statistical significance was p = 0.05.|t-test, 2 sided|The df = 13 for arm 1 (jawline injections) analysis of Jawline Rating Scale Assessments given by unblinded physician.|Treatment Difference = 4 Weeks after last injection - Baseline|The null hypothesis for the 7 participants placed randomly 1:1 in the jawline injection arm was that there would be no statistically significant change in the unblinded physician Jawline Rating Scale Assessment at baseline versus four weeks after last injection.||||0.00000031
72418738|NCT00952367|144347798|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.641|||<|0.001|TWO_SIDED|95.0|1.247|2.159|||Chi-squared|Degrees of freedom=1, Wald Chi-Square=12.514||Age of mother bearing, \<=30 years vs \>30 years||2.159|1.247|<0.001
72418739|NCT00952367|144347798|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.793||||0.06|TWO_SIDED|95.0|0.622|1.01|||Chi-squared|Degrees of freedom=1, Wald Chi-Square=3.529||Household register, local vs nonlocal||1.010|0.622|0.060
72418740|NCT00952367|144347798|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|7.369||||0.006|TWO_SIDED|95.0|1.672|32.479|||Chi-squared|Degrees of freedom=1, Wald Chi-Square=7.524||Mother's education level, illiteracy vs postgraduate or above||32.479|1.672|0.006
72418741|NCT00952367|144347798|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.443||||0.102|TWO_SIDED|95.0|1.001|11.843|||Chi-squared|Degrees of freedom=1, Wald Chi-Square=2.671||Mother's education level, elementary school vs postgraduate or above||11.843|1.001|0.102
72418742|NCT00952367|144347798|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.064||||0.159|TWO_SIDED|95.0|0.933|10.067|||Chi-squared|Degrees of freedom=1, Wald Chi-Square=1.984||Mother's education level, junior middle school vs postgraduate or above||10.067|0.933|0.159
72418743|NCT00952367|144347798|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.321||||0.662|TWO_SIDED|95.0|0.71|7.589|||Chi-squared|Degrees of freedom=1, Wald Chi-Square=0.191||Mother's education level, senior high school/vocational high school/technical secondary school vs postgraduate or above||7.589|0.710|0.662
72418744|NCT00952367|144347798|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.306|||<|0.001|TWO_SIDED|95.0|0.399|4.277|||Chi-squared|Degrees of freedom=1, Wald Chi-Square=13.525||Mother's education level, college/university vs postgraduate or above||4.277|0.399|<0.001
72418745|NCT00952367|144347798|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.217||||0.043|TWO_SIDED|95.0|0.719|6.831|||Chi-squared|Degrees of freedom=1, Wald Chi-Square=4.095||Family monthly income per capita, \<=600 RMB vs \>=10000 RMB||6.831|0.719|0.043
72418746|NCT00952367|144347798|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.089||||0.01|TWO_SIDED|95.0|0.739|5.906|||Chi-squared|Degrees of freedom=1, Wald Chi-Square=6.549||Family monthly income per capita, 600 to 1999 RMB vs \>=10000 RMB||5.906|0.739|0.010
72418747|NCT00952367|144347798|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.983||||0.021|TWO_SIDED|95.0|0.704|5.583|||Chi-squared|Degrees of freedom=1, Wald Chi-Square=5.313||Family monthly income per capita, 2000 to 4999 RMB vs \>=10000 RMB||5.583|0.704|0.021
72611453|NCT03427892|144751482|OTHER|Within subjects design; single group. Intent-to-treat (ITT) sample was used in the analysis, such that all participants who completed the baseline visit and at least one post-baseline assessment were included in the analysis.||||||0.19||||||To analyze mood symptoms, cognitive performance, and side effects, separate one-way repeated measures analyses of variance (ANVOA) were performed. Time (bsl, wk 4, and wk 8) was included as the within-subject factor.The above reported is TMT B.|ANOVA|One-way repeated measures analyses of variance (ANVOA) were performed. Time (bsl, wk 4, wk8) was included as the within-subject factor.||Primary Aim is to determine if brexpiprazole is associated with a reduction in depressive symptom severity in bipolar disorder outpatients. A sample size of 17 provides 80% power for a paired t-test to compare baseline to exit change scores on the MADRS of 7 (SD 10) (a more conservative change than with even the low 1 mg dose of brexpiprazole in Thase et. al. (2015)) with alpha=.05. A sample size of n=20 will allow for some early withdrawals without postbaseline data (10).||||.19
72611454|NCT03427892|144751483|OTHER|Within subjects design; single group. Intent-to-treat (ITT) sample was used in the analysis, such that all participants who completed the baseline visit and at least one post-baseline assessment were included in the analysis.|||||<|0.001||||||To analyze mood symptoms, cognitive performance, and side effects, separate one-way repeated measures analyses of variance (ANVOA) were performed. Time (bsl, wk 4, and wk 8) was included as the within-subject factor.|ANOVA|One-way repeated measures analyses of variance (ANVOA) were performed. Time (bsl, wk 4, wk8) was included as the within-subject factor.||Primary Aim is to determine if brexpiprazole is associated with a reduction in depressive symptom severity in bipolar disorder outpatients. A sample size of 17 provides 80% power for a paired t-test to compare baseline to exit change scores on the MADRS of 7 (SD 10) (a more conservative change than with even the low 1 mg dose of brexpiprazole in Thase et. al. (2015)) with alpha=.05. A sample size of n=20 will allow for some early withdrawals without postbaseline data (10).||||<.001
72418748|NCT00952367|144347798|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.06||||0.364|TWO_SIDED|95.0|0.344|3.267|||Chi-squared|Degrees of freedom=1, Wald Chi-Square=0.824||Family monthly income per capita, 5000 to 7999 RMB vs \>=10000 RMB||3.267|0.344|0.364
72418749|NCT00952367|144347798|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.58||||0.175|TWO_SIDED|95.0|0.1|3.347|||Chi-squared|Degrees of freedom=1, Wald Chi-Square=1.838||||3.347|0.100|0.175
72418750|NCT00952367|144347798|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.516|||<|0.001|TWO_SIDED|95.0|0.4|0.666|||Chi-squared|Degrees of freedom=1, Wald Chi-Square=25.960||Whether have brothers or sisters, no vs yes||0.666|0.400|<0.001
72418751|NCT00952367|144347799|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.255||||0.057|TWO_SIDED|95.0|0.062|1.044|||Chi-squared|Degrees of freedom=1, Wald Chi-Square=3.610||Birth information, preterm birth vs full-term birth||1.044|0.062|0.057
72418752|NCT00952367|144347799|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.666||||0.04|TWO_SIDED|95.0|0.451|0.981|||Chi-squared|Degrees of freedom=1, Wald Chi-Square=4.228||Household register, local vs nonlocal||0.981|0.451|0.040
72418753|NCT00952367|144347799|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.182||||0.044|TWO_SIDED|95.0|0.758|1.844|||Chi-squared|Degrees of freedom=1, Wald Chi-Square=4.074||Feeding manners within 6 months, pure breast feeding vs pure formula milk feeding||1.844|0.758|0.044
72418754|NCT00952367|144347799|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.707||||0.038|TWO_SIDED|95.0|0.42|1.191|||Chi-squared|Degrees of freedom=1, Wald Chi-Square=4.316||Feeding manners within 6 months, mixed feeding vs pure formula milk feeding||1.191|0.420|0.038
72418755|NCT00952367|144347799|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|92.229||||0.006|TWO_SIDED|95.0|3.993|2130.5|||Chi-squared|Degrees of freedom=1, Wald Chi-Square=7.438||Father's education level, illiteracy vs postgraduate or above||2130.500|3.993|0.006
72418756|NCT00952367|144347799|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.671||||0.778|TWO_SIDED|95.0|0.537|40.608|||Chi-squared|Degrees of freedom=1, Wald Chi-Square=0.079||Father's education level, elementary school vs postgraduate or above||40.608|0.537|0.778
72418757|NCT00952367|144347799|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.83||||0.756|TWO_SIDED|95.0|0.649|35.956|||Chi-squared|Degrees of freedom=1, Wald Chi-Square=0.096||Father's education level, junior high school vs postgraduate or above||35.956|0.649|0.756
72418758|NCT00952367|144347799|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.513||||0.179|TWO_SIDED|95.0|0.474|26.03|||Chi-squared|Degrees of freedom=1, Wald Chi-Square=1.807||Father's education level, senior high school/vocational high school/technical secondary school vs postgraduate or above||26.030|0.474|0.179
72418759|NCT00952367|144347799|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.029||||0.077|TWO_SIDED|95.0|0.412|22.292|||Chi-squared|Degrees of freedom=1, Wald Chi-Square=3.131||Father's education level, college/university vs postgraduate or above||22.292|0.412|0.077
72418760|NCT00952367|144347799|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.984||||0.056|TWO_SIDED|95.0|0.968|1.0|||Chi-squared|Degrees of freedom=1, Wald Chi-Square=3.648||Living space per capita, continuous variables||1.000|0.968|0.056
72418761|NCT00952367|144347799|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.729||||0.064|TWO_SIDED|95.0|0.522|1.018|||Chi-squared|Degrees of freedom=1, Wald Chi-Square=3.432||Vaccination history of Hib, no vs yes||1.018|0.522|0.064
72418762|NCT00952367|144347800|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.438||||0.019|TWO_SIDED|95.0|0.221|0.871|||Chi-squared|Degrees of freedom=1, Wald Chi-Square=5.538||Birth information, preterm birth vs full-term birth||0.871|0.221|0.019
72418763|NCT00952367|144347800|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.546|||<|0.001|TWO_SIDED|95.0|0.423|0.703|||Chi-squared|Degrees of freedom=1, Wald Chi-Square=21.938||Household register, local vs nonlocal||0.703|0.423|<0.001
72418764|NCT00952367|144347800|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.137||||0.559|TWO_SIDED|95.0|0.473|9.652|||Chi-squared|Degrees of freedom=1, Wald Chi-Square=0.341||Mother's education level, illiteracy vs graduate or above||9.652|0.473|0.559
72418765|NCT00952367|144347800|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.793||||0.626|TWO_SIDED|95.0|0.596|5.394|||Chi-squared|Degrees of freedom=1, Wald Chi-Square=0.238||Mother's education level, elementary school vs graduate or above||5.394|0.596|0.626
72418766|NCT00952367|144347800|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.972||||0.193|TWO_SIDED|95.0|0.699|5.562|||Chi-squared|Degrees of freedom=1, Wald Chi-Square=1.691||Mother's education level, junior middle school vs graduate or above||5.562|0.699|0.193
72611455|NCT03427892|144751484|OTHER|Within subjects design; single group. Intent-to-treat (ITT) sample was used in the analysis, such that all participants who completed the baseline visit and at least one post-baseline assessment were included in the analysis.||||||0.022||||||To analyze separate one-way repeated measures analyses of variance (ANOVA) were performed. Time (baseline, week 4, week 8) was included as the within-subject factor.Above is from baseline to week 8 for C-SSRS AA, IA, and ABA.|ANOVA|One-way repeated measures (ANOVA) were performed. Time (baseline, wk 4, wk 8) included as within-subject factor. Above is for C-SSRS AA,IA, and ABA.||Primary Aim is to determine if brexpiprazole is associated with a reduction in depressive symptom severity in bipolar disorder outpatients. A sample size of 17 provides 80% power for a paired t-test to compare baseline to exit change scores on the MADRS of 7 (SD 10) (a more conservative change than with even the low 1 mg dose of brexpiprazole in Thase et. al. (2015)) with alpha=.05. A sample size of n=20 will allow for some early withdrawals without postbaseline data (10).||||.022
72611456|NCT03427892|144751484|OTHER|Within subjects design; single group. Intent-to-treat (ITT) sample was used in the analysis, such that all participants who completed the baseline visit and at least one post-baseline assessment were included in the analysis.||||||0.163||||||To analyze mood symptoms, cognitive performance, and side effects, separate one-way repeated measures analyses of variance (ANVOA) were performed. Time (bsl, wk 4, and wk 8) was included as the within-subject factor.|ANOVA|One-way repeated measures analyses of variance (ANVOA) were performed. Time (bsl, wk 4, wk8) was included as the within-subject factor.||Primary Aim is to determine if brexpiprazole is associated with a reduction in depressive symptom severity in bipolar disorder outpatients. A sample size of 17 provides 80% power for a paired t-test to compare baseline to exit change scores on the MADRS of 7 (SD 10) (a more conservative change than with even the low 1 mg dose of brexpiprazole in Thase et. al. (2015)) with alpha=.05. A sample size of n=20 will allow for some early withdrawals without postbaseline data (10).||||.163
72418767|NCT00952367|144347800|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.907||||0.298|TWO_SIDED|95.0|0.679|5.353|||Chi-squared|Degrees of freedom=1, Wald Chi-Square=1.081||Mother's education level, senior high school/vocational high school/technical secondary school vs postgraduate or above||5.353|0.679|0.298
72418768|NCT00952367|144347800|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.233||||0.122|TWO_SIDED|95.0|0.439|3.464|||Chi-squared|Degrees of freedom=1, Wald Chi-Square=2.395||Mother's education level, college/university vs postgraduate or above||3.464|0.439|0.122
72611457|NCT03427892|144751485|OTHER|Within subjects design; single group. Intent-to-treat (ITT) sample was used in the analysis, such that all participants who completed the baseline visit and at least one post-baseline assessment were included in the analysis.||||||0.133||||||To analyze mood symptoms, cognitive performance, and side effects, separate one-way repeated measures analyses of variance (ANVOA) were performed. Time (bsl, wk 4, and wk 8) was included as the within-subject factor.|ANOVA|One-way repeated measures analyses of variance (ANVOA) were performed. Time (bsl, wk 4, wk8) was included as the within-subject factor.||Primary Aim is to determine if brexpiprazole is associated with a reduction in depressive symptom severity in bipolar disorder outpatients. A sample size of 17 provides 80% power for a paired t-test to compare baseline to exit change scores on the MADRS of 7 (SD 10) (a more conservative change than with even the low 1 mg dose of brexpiprazole in Thase et. al. (2015)) with alpha=.05. A sample size of n=20 will allow for some early withdrawals without postbaseline data (10).||||.133
72418769|NCT00952367|144347800|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.666||||0.001|TWO_SIDED|95.0|0.52|0.855|||Chi-squared|Degrees of freedom=1, Wald Chi-Square=10.233||Whether have brothers or sisters, no vs yes||0.855|0.520|0.001
72418770|NCT04570436|144347807|SUPERIORITY||Mean Difference (Final Values)|30.9|STANDARD_ERROR_OF_MEAN|2.85|<|0.0001|ONE_SIDED|95.0|26.2||||Mixed Models Analysis|||"The sensitivity and integrity of the study was validated by comparing the mean responses of diazepam, the positive control (C), to the placebo (P):~H0: μC - μP ≤ δ1 versus Ha: μC - μP \> δ1 where δ1 = 15"|||26.2|<0.0001
72418771|NCT04570436|144347807|NON_INFERIORITY|Non-inferiority margin = 11|Mean Difference (Final Values)|10.0|STANDARD_ERROR_OF_MEAN|2.84||0.3581|ONE_SIDED|95.0||14.7|||Mixed Models Analysis|||"The primary analysis evaluated whether gabapentin (T) produced mean responses that show abuse potential similar to placebo.~H0: μT - μP ≥ δ3 versus Ha: μT - μP \< δ3 where δ3 =11"||14.7||0.3581
72418772|NCT04570436|144347807|NON_INFERIORITY|Non-inferiority margin = 11|Mean Difference (Final Values)|9.5|STANDARD_ERROR_OF_MEAN|2.85||0.3051|ONE_SIDED|95.0||14.3|||Mixed Models Analysis|||"The primary analysis evaluated whether gabapentin (T) produced mean responses that show abuse potential similar to placebo.~H0: μT - μP ≥ δ3 versus Ha: μT - μP \< δ3 where δ3 =11"||14.3||0.3051
72418773|NCT04570436|144347807|NON_INFERIORITY|Non-inferiority margin = 11|Mean Difference (Final Values)|8.8|STANDARD_ERROR_OF_MEAN|2.83||0.2179|ONE_SIDED|95.0||13.5|||Mixed Models Analysis|||"The primary analysis evaluated whether gabapentin (T) produced mean responses that show abuse potential similar to placebo.~H0: μT - μP ≥ δ3 versus Ha: μT - μP \< δ3 where δ3 =11"||13.5||0.2179
72326538|NCT04389866|144176194|SUPERIORITY||Mean Difference (Final Values)|-0.714|STANDARD_DEVIATION|0.497||7.28e-05|TWO_SIDED|||||The threshold for statistical significance was p = 0.05.|t-test, 2 sided|The df = 13 for jawline and lateral (zygomatic) cheek area injections arm analysis of Jawline Rating Scale Assessments given by unblinded physician.|Treatment Difference = 4 Weeks after last injection - Baseline|The null hypothesis for the 7 participants placed randomly 1:1 in the jawline and lateral (zygomatic) cheek area injections arm was that there would be no statistically significant change in the unblinded physician Jawline Rating Scale Assessment at baseline versus four weeks after last injection.||||0.0000728
72326539|NCT04389866|144176195|SUPERIORITY||Mean Difference (Final Values)|-0.571|STANDARD_DEVIATION|0.611||0.014|TWO_SIDED|||||The threshold for statistical significance was p = 0.05.|t-test, 2 sided|The df = 13 for jawline injections analysis of Jawline Rating Scale Assessments given by subjects.|Treatment Difference = 4 Weeks after last injection - Baseline|The null hypothesis for the 7 participants placed randomly 1:1 in the jawline injection arm was that there would be no statistically significant change in the subjects' Jawline Rating Scale Assessment at baseline versus four weeks after last injection.||||0.014
72326540|NCT04389866|144176195|SUPERIORITY||Mean Difference (Final Values)|-0.714|STANDARD_DEVIATION|0.726||0.0065|TWO_SIDED|||||The threshold for statistical significance was p = 0.05.|t-test, 2 sided|The df = 13 for jawline and lateral (zygomatic) cheek area injections analysis of Jawline Rating Scale Assessments given by the subjects.|Treatment Difference = 4 Weeks after last injection - Baseline|The null hypothesis for the 7 participants placed randomly 1:1 in the jawline and lateral (zygomatic) cheek area injections arm was that there would be no statistically significant change in the subjects' Jawline Rating Scale Assessment at baseline versus four weeks after last injection.||||0.0065
72326541|NCT02967679|144176212|OTHER||Mean Difference (Net)|1.67|STANDARD_DEVIATION|11.45||0.7615|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.7615
72326542|NCT02967679|144176213|OTHER||Mean Difference (Net)|0.2|STANDARD_DEVIATION|8.89||0.5995|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.5995
72418774|NCT04570436|144347807|NON_INFERIORITY|Non-inferiority margin = 0|Mean Difference (Final Values)|20.9|STANDARD_ERROR_OF_MEAN|2.84|<|0.0001|ONE_SIDED|95.0|16.3||||Mixed Models Analysis|||"The null and alternative hypotheses for evaluating whether gabapentin (T) produced mean responses that show less abuse potential than diazepam (C) were:~H0: μC - μT ≤ δ2 versus Ha: μC - μT \> δ2 where δ2 =0"|||16.3|<0.0001
72418775|NCT04570436|144347807|NON_INFERIORITY|Non-inferiority margin = 0|Mean Difference (Final Values)|21.4|STANDARD_ERROR_OF_MEAN|2.84|<|0.0001|ONE_SIDED|95.0|16.7||||Mixed Models Analysis|||"The null and alternative hypotheses for evaluating whether gabapentin (T) produced mean responses that show less abuse potential than diazepam (C) were:~H0: μC - μT ≤ δ2 versus Ha: μC - μT \> δ2 where δ2 =0"|||16.7|<0.0001
72418776|NCT04570436|144347807|NON_INFERIORITY|Non-inferiority margin = 0|Mean Difference (Final Values)|22.1|STANDARD_ERROR_OF_MEAN|2.85|<|0.0001|ONE_SIDED|95.0|17.4||||Mixed Models Analysis|||"The null and alternative hypotheses for evaluating whether gabapentin (T) produced mean responses that show less abuse potential than diazepam (C) were:~H0: μC - μT ≤ δ2 versus Ha: μC - μT \> δ2 where δ2 =0"|||17.4|<0.0001
72326543|NCT02967679|144176214|OTHER||Mean Difference (Net)|4.8|STANDARD_DEVIATION|8.4||0.1641|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.1641
72326544|NCT02967679|144176215|OTHER||Mean Difference (Net)|8.5|STANDARD_DEVIATION|16.5||0.0353|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.0353
72326545|NCT02967679|144176216|OTHER||Mean Difference (Net)|-0.5|STANDARD_DEVIATION|1.4||0.2642|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.2642
72326546|NCT02967679|144176217|OTHER||Mean Difference (Net)|-0.6|STANDARD_DEVIATION|1.2||0.1777|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.1777
72326547|NCT02967679|144176218|OTHER||Mean Difference (Net)|4.5|STANDARD_DEVIATION|8.2||0.0371|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.0371
72326548|NCT02967679|144176219|OTHER||Mean Difference (Net)|-2.2|STANDARD_DEVIATION|2.9||0.0142|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.0142
72326549|NCT02967679|144176221|OTHER||Mean Difference (Net)|0.111|STANDARD_DEVIATION|0.201||0.1055|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.1055
72326550|NCT02967679|144176222|OTHER||Mean Difference (Net)|9.84|STANDARD_DEVIATION|28.16||0.213|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.2130
72326551|NCT02967679|144176223|OTHER||Mean Difference (Net)|0.068|STANDARD_DEVIATION|0.112||0.0393|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.0393
72326552|NCT02967679|144176224|OTHER||Mean Difference (Net)|-5.905|STANDARD_DEVIATION|6.283||0.0004|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.0004
72326553|NCT02967679|144176225|OTHER||Mean Difference (Net)|-4.28|STANDARD_DEVIATION|32.21||0.3303|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.3303
72418777|NCT04570436|144347809|OTHER||Mean Difference (Final Values)|325.8|STANDARD_ERROR_OF_MEAN|113.38||0.0023|ONE_SIDED|90.0|138.2||||Mixed Models Analysis||||||138.2|0.0023
72326554|NCT02967679|144176226|OTHER||Mean Difference (Net)|0.0|STANDARD_DEVIATION|0.092||0.9229|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.9229
72326555|NCT00600067|144176235|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.36|STANDARD_ERROR_OF_MEAN|0.17||0.0381|TWO_SIDED|95.0|-0.69|-0.02|||ANCOVA|||||-0.02|-0.69|0.0381
72326556|NCT00600067|144176236|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.7|STANDARD_ERROR_OF_MEAN|1.26|<|0.0001|TWO_SIDED|95.0|-9.18|-4.21|||ANCOVA|||||-4.21|-9.18|<0.0001
72326557|NCT00251693|144176255|NON_INFERIORITY_OR_EQUIVALENCE|If the lower bound of the 95% CI was greater than -10%, noninferiority was concluded. Superiority of primary efficacy endpoint was assessed by comparing the crude healing rate of dexlansoprazole MR 60 mg dose to that of lansoprazole 30 mg using a Cochran Mantel Haenszel (CMH) test with baseline LA EE Grade as strata.|Difference in percentage|6.33||||0.004||95.0|2.17|10.48||Unadjusted p-value is presented. The overall 0.05 level of significance for the multiple comparisons of each dexlansoprazole dose to lansoprazole was controlled using Hochberg's method.|Cochran-Mantel-Haenszel|||||10.48|2.17|0.004
72418778|NCT04570436|144347809|OTHER||Mean Difference (Final Values)|140.5|STANDARD_ERROR_OF_MEAN|113.01||0.2157|TWO_SIDED|90.0|-82.7|363.7|||Mixed Models Analysis|||||363.7|-82.7|0.2157
72418779|NCT04570436|144347809|OTHER||Mean Difference (Final Values)|155.4|STANDARD_ERROR_OF_MEAN|113.25||0.172|TWO_SIDED|90.0|-68.3|379.1|||Mixed Models Analysis|||||379.1|-68.3|0.1720
72418780|NCT04570436|144347809|OTHER||Mean Difference (Final Values)|212.2|STANDARD_ERROR_OF_MEAN|113.01||0.0622|TWO_SIDED|90.0|-11.0|435.5|||Mixed Models Analysis|||||435.5|-11.0|0.0622
72611458|NCT03427892|144751486|OTHER|Within subjects design; single group. Intent-to-treat (ITT) sample was used in the analysis, such that all participants who completed the baseline visit and at least one post-baseline assessment were included in the analysis.||||||0.002||||||To analyze mood symptoms, cognitive performance, and side effects, separate one-way repeated measures analyses of variance (ANVOA) were performed. Time (bsl, wk 4, and wk 8) was included as the within-subject factor.|ANOVA|One-way repeated measures analyses of variance (ANVOA) were performed. Time (bsl, wk 4, wk8) was included as the within-subject factor.||Primary Aim is to determine if brexpiprazole is associated with a reduction in depressive symptom severity in bipolar disorder outpatients. A sample size of 17 provides 80% power for a paired t-test to compare baseline to exit change scores on the MADRS of 7 (SD 10) (a more conservative change than with even the low 1 mg dose of brexpiprazole in Thase et. al. (2015)) with alpha=.05. A sample size of n=20 will allow for some early withdrawals without postbaseline data (10).||||.002
72611459|NCT03427892|144751487|OTHER|Within subjects design; single group. Intent-to-treat (ITT) sample was used in the analysis, such that all participants who completed the baseline visit and at least one post-baseline assessment were included in the analysis.||||||0.002||||||To analyze mood symptoms, cognitive performance, and side effects, separate one-way repeated measures analyses of variance (ANVOA) were performed. Time (bsl, wk 4, and wk 8) was included as the within-subject factor.|ANOVA|One-way repeated measures analyses of variance (ANVOA) were performed. Time (bsl, wk 4, wk8) was included as the within-subject factor.||Primary Aim is to determine if brexpiprazole is associated with a reduction in depressive symptom severity in bipolar disorder outpatients. A sample size of 17 provides 80% power for a paired t-test to compare baseline to exit change scores on the MADRS of 7 (SD 10) (a more conservative change than with even the low 1 mg dose of brexpiprazole in Thase et. al. (2015)) with alpha=.05. A sample size of n=20 will allow for some early withdrawals without postbaseline data (10).||||.002
72326558|NCT00251693|144176255|NON_INFERIORITY_OR_EQUIVALENCE|If the lower bound of the 95% CI was greater than -10%, noninferiority was concluded. Superiority of primary efficacy endpoint was assessed by comparing the crude healing rate of dexlansoprazole MR 90 mg dose to that of lansoprazole 30 mg using a Cochran Mantel Haenszel (CMH) test with baseline LA EE Grade as strata.|Difference in percentage|6.84||||0.001||95.0|2.7|10.98||Unadjusted p-value is presented. The overall 0.05 level of significance for the multiple comparisons of each dexlansoprazole dose to lansoprazole was controlled using Hochberg's method.|Cochran-Mantel-Haenszel|||||10.98|2.70|0.001
72326559|NCT00251693|144176255|SUPERIORITY_OR_OTHER|||||||0.727||95.0||||Statistical significance was determined at the 0.05 level without adjustment for multiple comparisons.|Cochran-Mantel-Haenszel|||||||0.727
72326560|NCT00251693|144176256|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||Unadjusted p-value is presented. Statistical significance was determined at 0.05 level by Hommel-Simes method within treatment and Hochberg method for comparisons of each dexlansoprazole dose to lansoprazole.|Cochran-Mantel-Haenszel|||||||0.002
72326561|NCT00251693|144176256|SUPERIORITY_OR_OTHER|||||||0.045||95.0||||Unadjusted p-value is presented. Statistical significance was determined at 0.05 level by Hommel-Simes method within treatment and Hochberg method for comparisons of each dexlansoprazole dose to lansoprazole.|Cochran-Mantel-Haenszel|||||||0.045
72326562|NCT00251693|144176256|SUPERIORITY_OR_OTHER|||||||0.245||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Cochran-Mantel-Haenszel|||||||0.245
72326563|NCT00251693|144176257|SUPERIORITY_OR_OTHER|||||||0.011||95.0||||Unadjusted p-value is presented. Statistical significance was determined at 0.05 level by Hommel-Simes method within treatment and Hochberg method for comparisons of each dexlansoprazole dose to lansoprazole.|Log Rank|||||||0.011
72326564|NCT00251693|144176257|SUPERIORITY_OR_OTHER|||||||0.017||95.0||||Unadjusted p-value is presented. Statistical significance was determined at 0.05 level by Hommel-Simes method within treatment and Hochberg method for comparisons of each dexlansoprazole dose to lansoprazole.|Log Rank|||||||0.017
72326565|NCT00251693|144176257|SUPERIORITY_OR_OTHER|||||||0.927||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Log Rank|||||||0.927
72326566|NCT00251693|144176258|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was supported if the lower bound of the 95% CI for the difference with lansoprazole 30 mg of the estimated 8-week healing rate was greater than -10%. Superiority was assessed based on log-rank tests comparing treatments for the endpoints.|Difference in percentage|6.2||||0.06||95.0|2.3|10.11||Unadjusted p-value is presented. The overall 0.05 level of significance for the multiple comparisons of each dexlansoprazole dose to lansoprazole was controlled using Hochberg's method.|Log Rank|||||10.11|2.30|0.060
72326567|NCT00251693|144176258|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was supported if the lower bound of the 95% CI for the difference with lansoprazole 30 mg of the estimated 8-week healing rate was greater than -10%. Superiority was assessed based on log-rank tests comparing treatments for the endpoints.|Difference in percentage|6.08||||0.029||95.0|2.16|10.0||Unadjusted p-value is presented. The overall 0.05 level of significance for the multiple comparisons of each dexlansoprazole dose to lansoprazole was controlled using Hochberg's method.|Log Rank|||||10.00|2.16|0.029
72418781|NCT04570436|144347809|OTHER||Mean Difference (Final Values)|-185.0|STANDARD_ERROR_OF_MEAN|113.04||0.1031|TWO_SIDED|90.0|-409.0|37.94|||Mixed Models Analysis|||||37.94|-409|0.1031
72418782|NCT04570436|144347809|OTHER||Mean Difference (Final Values)|-170.0|STANDARD_ERROR_OF_MEAN|112.97||0.1334|TWO_SIDED|90.0|-394.0|52.71|||Mixed Models Analysis|||||52.71|-394|0.1334
72418783|NCT04570436|144347809|OTHER||Mean Difference (Final Values)|-114.0|STANDARD_ERROR_OF_MEAN|113.59||0.3189|TWO_SIDED|90.0|-338.0|110.8|||Mixed Models Analysis|||||110.8|-338|0.3189
72418784|NCT04570436|144347810|OTHER||Mean Difference (Final Values)|55.77|STANDARD_ERROR_OF_MEAN|5.362|<|0.0001|ONE_SIDED|90.0|46.89||||Mixed Models Analysis||||||46.89|<0.0001
72418785|NCT04570436|144347810|OTHER||Mean Difference (Final Values)|17.18|STANDARD_ERROR_OF_MEAN|5.348||0.0016|TWO_SIDED|90.0|6.61|27.74|||Mixed Models Analysis|||||27.74|6.61|0.0016
72418786|NCT04570436|144347810|OTHER||Mean Difference (Final Values)|21.38|STANDARD_ERROR_OF_MEAN|5.36||0.0001|TWO_SIDED|90.0|10.79|31.96|||Mixed Models Analysis|||||31.96|10.79|0.0001
72418787|NCT04570436|144347810|OTHER||Mean Difference (Final Values)|22.5|STANDARD_ERROR_OF_MEAN|5.352|<|0.0001|TWO_SIDED|90.0|11.92|33.07|||Mixed Models Analysis|||||33.07|11.92|<0.0001
72418788|NCT04570436|144347810|OTHER||Mean Difference (Final Values)|-38.6|STANDARD_ERROR_OF_MEAN|5.312|<|0.0001|TWO_SIDED|90.0|-49.1|-28.1|||Mixed Models Analysis|||||-28.1|-49.1|<0.0001
72611460|NCT03427892|144751488|OTHER|Within subjects design; single group. Intent-to-treat (ITT) sample was used in the analysis, such that all participants who completed the baseline visit and at least one post-baseline assessment were included in the analysis.||||||0.005||||||Pairwise comparisons were also performed to determine which time points were significantly different from one another. Baseline to week 8 is reported above.|t-test, 2 sided|Pairwise comparisons were also performed to determine which time points were significantly different from one another.||Primary Aim is to determine if brexpiprazole is associated with a reduction in depressive symptom severity in bipolar disorder outpatients. A sample size of 17 provides 80% power for a paired t-test to compare baseline to exit change scores on the MADRS of 7 (SD 10) (a more conservative change than with even the low 1 mg dose of brexpiprazole in Thase et. al. (2015)) with alpha=.05. A sample size of n=20 will allow for some early withdrawals without postbaseline data (10).||||.005
72611461|NCT03427892|144751489|OTHER|Within subjects design; single group. Intent-to-treat (ITT) sample was used in the analysis, such that all participants who completed the baseline visit and at least one post-baseline assessment were included in the analysis.|||||<|0.001||||||To analyze mood symptoms, cognitive performance, and side effects, separate one-way repeated measures analyses of variance (ANVOA) were performed. Time (bsl, wk 4, and wk 8) was included as the within-subject factor.|ANOVA|One-way repeated measures analyses of variance (ANVOA) were performed. Time (bsl, wk 4, wk8) was included as the within-subject factor.||Primary Aim is to determine if brexpiprazole is associated with a reduction in depressive symptom severity in bipolar disorder outpatients. A sample size of 17 provides 80% power for a paired t-test to compare baseline to exit change scores on the MADRS of 7 (SD 10) (a more conservative change than with even the low 1 mg dose of brexpiprazole in Thase et. al. (2015)) with alpha=.05. A sample size of n=20 will allow for some early withdrawals without postbaseline data (10).||||<.001
72418789|NCT04570436|144347810|OTHER||Mean Difference (Final Values)|-34.4|STANDARD_ERROR_OF_MEAN|5.308|<|0.0001|TWO_SIDED|90.0|-44.9|-23.9|||Mixed Models Analysis|||||-23.9|-44.9|<0.0001
72418790|NCT04570436|144347810|OTHER||Mean Difference (Final Values)|-33.3|STANDARD_ERROR_OF_MEAN|5.337|<|0.0001|TWO_SIDED|90.0|-43.8|-22.7|||Mixed Models Analysis|||||-22.7|-43.8|<0.0001
72418791|NCT04570436|144347812|OTHER||Mean Difference (Final Values)|234.9|STANDARD_ERROR_OF_MEAN|38.174|<|0.0001|ONE_SIDED|90.0|171.7||||Mixed Models Analysis||||||171.7|<0.0001
72418792|NCT04570436|144347812|OTHER||Mean Difference (Final Values)|66.3|STANDARD_ERROR_OF_MEAN|38.048||0.0834|TWO_SIDED|90.0|-8.86|141.5|||Mixed Models Analysis|||||141.5|-8.86|0.0834
72418793|NCT04570436|144347812|OTHER||Mean Difference (Final Values)|99.06|STANDARD_ERROR_OF_MEAN|38.128||0.0103|TWO_SIDED|90.0|23.75|174.4|||Mixed Models Analysis|||||174.4|23.75|0.0103
72418794|NCT04570436|144347812|OTHER||Mean Difference (Final Values)|97.2|STANDARD_ERROR_OF_MEAN|38.048||0.0116|TWO_SIDED|90.0|22.05|172.4|||Mixed Models Analysis|||||172.4|22.05|0.0116
72418795|NCT04570436|144347812|OTHER||Mean Difference (Final Values)|-169.0|STANDARD_ERROR_OF_MEAN|38.06|<|0.0001|TWO_SIDED|90.0|-244.0|-93.4|||Mixed Models Analysis|||||-93.4|-244|<0.0001
72418796|NCT04570436|144347812|OTHER||Mean Difference (Final Values)|-136.0|STANDARD_ERROR_OF_MEAN|38.036||0.0005|TWO_SIDED|90.0|-211.0|-60.7|||Mixed Models Analysis|||||-60.7|-211|0.0005
72418797|NCT04570436|144347812|OTHER||Mean Difference (Final Values)|-138.0|STANDARD_ERROR_OF_MEAN|38.243||0.0004|TWO_SIDED|90.0|-213.0|-62.2|||Mixed Models Analysis|||||-62.2|-213|0.0004
72418798|NCT00781391|144347825|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority analysis included the mITT and PP analysis sets for both the on treatment and overall study period, although mITT on-treatment was considered primary|Hazard Ratio (HR)|0.79|||<|0.0001|TWO_SIDED|97.5|0.632|0.985||Two stratification factor covariates: 1) CHADS2 score 2) dose-adjustment factor. If upper limit of CI of HR was below 1.38, then non-inferiority to warfarin was established for group.|Cox proportional hazards model|||The primary efficacy endpoint, time to the first occurrence of stroke/SEE, was first compared concurrently between each of the 2 edoxaban groups and warfarin group using the mITT Analysis Set in the on-treatment period for non-inferiority. In order to control the study-wise type-I error rate of two-sided α=0.05 for non-inferiority, each of these 2 comparisons were performed at the statistical significance level of two-sided α=0.025, respectively.||.985|.632|<.0001
72418799|NCT00781391|144347825|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority analysis included the mITT and PP analysis sets for both the on treatment and overall study period, although mITT on-treatment was considered primary|Hazard Ratio (HR)|1.07||||0.0055|TWO_SIDED|97.5|0.874|1.314||Two stratification factor covariates: 1) CHADS2 score 2) dose-adjustment factor. If upper limit of CI of HR was below 1.38, then non-inferiority to warfarin was established for group.|Cox proportional hazards model|||The primary efficacy endpoint, time to the first occurrence of stroke/SEE, was first compared concurrently between each of the 2 edoxaban groups and warfarin group using the mITT Analysis Set in the on-treatment period for non-inferiority. In order to control the study-wise type-I error rate of two-sided α=0.05 for non-inferiority, each of these 2 comparisons were performed at the statistical significance level of two-sided α=0.025, respectively.||1.314|.874|.0055
72418800|NCT00781391|144347826|NON_INFERIORITY_OR_EQUIVALENCE|If the upper limit of this CI of the hazard ratio was below 1.38, then non-inferiority to warfarin was considered established for the edoxaban treatment group.|Hazard Ratio (HR)|0.86|||<|0.0001|TWO_SIDED|97.5|0.719|1.029|||Cox proportional hazards model|||Non-inferiority or equivalence analysis; Non-inferiority analysis. The non-inferiority analysis included the mITT and PP analysis sets for both the on treatment and overall study period, although mITT on-treatment was considered primary.||1.029|.719|<.0001
72418801|NCT00781391|144347826|NON_INFERIORITY_OR_EQUIVALENCE|If the upper limit of this CI of the hazard ratio was below 1.38, then non-inferiority to warfarin was considered established for the edoxaban treatment group.|Hazard Ratio (HR)|1.13||||0.0074|TWO_SIDED|97.5|0.955|1.336|||Cox proportional hazards model|||Non-inferiority or equivalence analysis; Non-inferiority analysis. The non-inferiority analysis included the mITT and PP analysis sets for both the on treatment and overall study period, although mITT on-treatment was considered primary.||1.336|.955|.0074
72418802|NCT00781391|144347827|NON_INFERIORITY_OR_EQUIVALENCE|The primary efficacy endpoint, time to the first occurrence of stroke/SEE, was first compared concurrently between each of the 2 edoxaban groups and warfarin group using the mITT Analysis Set in the on-treatment period for non-inferiority. In order to control the study-wise type-I error rate of two-sided α=0.05 for non-inferiority, each of these 2 comparisons were performed at the statistical significance level of two-sided α=0.025, respectively|Hazard Ratio (HR)|0.79|||<|0.0001|TWO_SIDED|97.5|0.634|0.989|||Cox proportional hazards model|||The non-inferiority analysis included the mITT and PP analysis sets for both the on treatment and overall study period, although mITT on-treatment was considered primary.||.989|.634|<.0001
72418803|NCT00781391|144347827|NON_INFERIORITY_OR_EQUIVALENCE|The primary efficacy endpoint, time to the first occurrence of stroke/SEE, was first compared concurrently between each of the 2 edoxaban groups and warfarin group using the mITT Analysis Set in the on-treatment period for non-inferiority. In order to control the study-wise type-I error rate of two-sided α=0.05 for non-inferiority, each of these 2 comparisons were performed at the statistical significance level of two-sided α=0.025, respectively.|Hazard Ratio (HR)|1.08||||0.0064|TWO_SIDED|97.5|0.878|1.32|||Cox proportional hazards model|||The non-inferiority analysis included the mITT and PP analysis sets for both the on treatment and overall study period, although mITT on-treatment was considered primary.||1.32|.878|.0064
72418804|NCT00781391|144347828|NON_INFERIORITY_OR_EQUIVALENCE|"In order to control the study-wise type-I error rate of two-sided α=0.05 for non-inferiority, each of these 2 comparisons were performed at the statistical significance level of two-sided α=0.025, respectively.~If the upper limit of this CI of the hazard ratio was below 1.38, then non-inferiority to warfarin was considered established for the edoxaban treatment group."|Hazard Ratio (HR)|0.86|||<|0.0001|TWO_SIDED|97.5|0.72|1.032|||Cox proportional hazards model|||The non-inferiority analysis included the mITT and PP analysis sets for both the on-treatment and overall study period, although mITT on-treatment was considered primary.||1.032|.720|<.0001
72418805|NCT00781391|144347828|NON_INFERIORITY_OR_EQUIVALENCE|"In order to control the study-wise type-I error rate of two-sided α=0.05 for non-inferiority, each of these 2 comparisons were performed at the statistical significance level of two-sided α=0.025, respectively.~If the upper limit of this CI of the hazard ratio was below 1.38, then non-inferiority to warfarin was considered established for the edoxaban treatment group."|Hazard Ratio (HR)|1.13||||0.0084|TWO_SIDED|97.5|0.958|1.34|||Cox proportional hazards model|||The non-inferiority analysis included the mITT and PP analysis sets for both the on-treatment and overall study period, although mITT on-treatment was considered primary.||1.34|.958|.0084
72418806|NCT00781391|144347829|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.87||||0.081|TWO_SIDED|99.0|0.709|1.068|||Log Rank|||The superiority analysis included the ITT analysis set||1.068|.709|.081
72611462|NCT03427892|144751490|OTHER|Within subjects design; single group. Intent-to-treat (ITT) sample was used in the analysis, such that all participants who completed the baseline visit and at least one post-baseline assessment were included in the analysis.||||||0.295||||||Pairwise comparisons were also performed to determine which time points were significantly different from one another. Baseline to week 8 is reported above.|t-test, 2 sided|Pairwise comparisons were also performed to determine which time points were significantly different from one another.||Primary Aim is to determine if brexpiprazole is associated with a reduction in depressive symptom severity in bipolar disorder outpatients. A sample size of 17 provides 80% power for a paired t-test to compare baseline to exit change scores on the MADRS of 7 (SD 10) (a more conservative change than with even the low 1 mg dose of brexpiprazole in Thase et. al. (2015)) with alpha=.05. A sample size of n=20 will allow for some early withdrawals without postbaseline data (10).||||.295
72418807|NCT00781391|144347830|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.87||||0.0053|TWO_SIDED|95.0|0.786|0.959|||Log Rank|||the time to first event was estimated by a KM estimate and was compared between the edoxaban 60 mg group and the warfarin group using a log-rank test at a pairwise comparison significance level of α=0.01.||.959|.786|.0053
72418808|NCT00781391|144347831|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.89||||0.0109|TWO_SIDED|95.0|0.806|0.972|||Log Rank|||the time to first event was estimated by a KM estimate and was compared between the edoxaban 60 mg group and the warfarin group using a log-rank test at a pairwise comparison significance level of α=0.01.||.972|.806|.0109
72418809|NCT00781391|144347832|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.9||||0.0168|TWO_SIDED|95.0|0.823|0.981|||Log Rank|||the time to first event was estimated by a KM estimate and was compared between the edoxaban 60 mg group and the warfarin group using a log-rank test at a pairwise comparison significance level of α=0.01.||.981|.823|.0168
72418810|NCT00781391|144347833|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.8||||0.0009|TWO_SIDED|95.0|0.707|0.914|||Regression, Cox|||All Major Adjudicated Bleeding Events, Safety Analysis Set On-treatment period||.914|.707|.0009
72418811|NCT00781391|144347833|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.47|||<|0.0001|TWO_SIDED|95.0|0.406|0.548|||Regression, Cox|||"All Major Adjudicated Bleeding Events, Safety Analysis Set On-treatment period.~The HR, two-sided CI, and p-value for pairwise comparisons versus Warfarin are based on the Cox regression model with counting process approach for on-treatment including treatment and the two stratification factors as covariates: the dichotomized CHADS2 score and the dichotomized dose-adjustment factor"||.548|.406|<.0001
72418812|NCT00781391|144347833|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.86|||<|0.0001|TWO_SIDED|95.0|0.8|0.918|||Regression, Cox|||Major or Clinically Relevant Non-Major, high dose vs. warfarin||.918|.800|<.0001
72611463|NCT00274456|144751491|SUPERIORITY_OR_OTHER_LEGACY|||||||0.224||95.0||||"A step-down approach was used to compare treatment regimens. First an overall test of treatment difference (a 3-degree-of -freedom test) was performed. Pairwise comparisons were performed only if this test was significant."|Cochran-Mantel-Haenszel|CMH test was stratified by study site||Independent reader assessed ORR. As per the protocol, if the conclusions from the investigator and independent assessments of response rate were the same, the investigator assessment was considered the primary analysis of response rate. If the conclusions were different, the independent radiology reader assessment was considered the primary analysis of response rate. The conclusions were different.||||0.224
72611464|NCT00274456|144751491|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||"A step-down approach was used to compare treatment regimens. First an overall test of treatment difference (a 3-degree-of -freedom test) was performed. Pairwise comparisons were performed only if this test was significant."|Cochran-Mantel-Haenszel|CMH was stratified by study site||Investigator assessed ORR. As per the protocol, if the conclusions from the investigator and independent assessments of response rate were the same, the investigator assessment was considered the primary analysis of response rate. If the conclusions were different, the independent radiology reader assessment was considered the primary analysis of response rate. The conclusions were different.||||<0.001
72611465|NCT00274456|144751491|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002||95.0|||||Cochran-Mantel-Haenszel|CMH test was stratified by study site||Investigator assessed ORR||||0.002
72611466|NCT00274456|144751491|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel|CMH test was stratified by study site.||Investigator assessed ORR||||<0.001
72611467|NCT00274456|144751491|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|||||||Cochran-Mantel-Haenszel|CMH test was stratified by study site||Investigator assessed ORR||||>0.05
72611468|NCT00274456|144751491|SUPERIORITY_OR_OTHER_LEGACY|||||||0.024||95.0|||||Cochran-Mantel-Haenszel|CMH test was stratified by study site.||Investigator assessed ORR||||0.024
72418813|NCT00781391|144347833|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.62|||<|0.0001|TWO_SIDED|95.0|0.575|0.666|||Regression, Cox|||Major or Clinically Relevant Non-Major, low dose vs. warfarin||.666|.575|<.0001
72418814|NCT01274182|144347846|EQUIVALENCE|The PK parameters were transformed prior to analysis using a logarithmic transformation. An analysis of variance (ANOVA) was used to analyze the transformed data including treatment group only as a factor in the model. The confidence interval for the difference between the two products on the transformed scale was obtained from the ANOVA model, which was then be back-transformed (exp base e) to obtain the confidence interval for the ratio on the original scale.|Geometric mean ratio|1.106|||||TWO_SIDED|90.0|1.01|1.21|||||GP2013 arm is the numerator and MabThera arm is the denominator|PK bioequivalence is defined as AUC(0-inf) of the drugs being comparable, i.e. the two-sided 90% CI for the ratio of the geometric means (GP2013/MabThera) is within the predefined bioequivalence limits of 0.8 to 1.25.||1.210|1.010|
72611469|NCT00274456|144751491|SUPERIORITY_OR_OTHER_LEGACY|||||||0.099||95.0|||||Cochran-Mantel-Haenszel|CMH test was stratified by study site.||Investigator assessed ORR||||0.099
72611470|NCT00274456|144751491|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002||95.0|||||Cochran-Mantel-Haenszel|CMH test was stratified by study site.||Investigator assessed ORR||||0.002
72611471|NCT00274456|144751492|SUPERIORITY_OR_OTHER_LEGACY|||||||0.027|||||||Cochran-Mantel-Haenszel|CMH test was stratified by study site.||Independent assessed DCR||||0.027
72611472|NCT00274456|144751492|SUPERIORITY_OR_OTHER_LEGACY|||||||0.009|||||||Cochran-Mantel-Haenszel|CMH test was stratified by study site.||Independent assessed DCR||||0.009
72611473|NCT00274456|144751492|SUPERIORITY_OR_OTHER_LEGACY|||||||0.017|||||||Cochran-Mantel-Haenszel|CMH test was stratified by study site.||Independent assessed DCR||||0.017
72611474|NCT00274456|144751492|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|||||||Cochran-Mantel-Haenszel|CMH test was stratified by study site.||Independent assessed DCR||||>0.05
72611475|NCT00274456|144751492|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|||||||Cochran-Mantel-Haenszel|CMH test was stratified by study site.||Independent assessed DCR||||>0.05
72611476|NCT00274456|144751492|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|||||||Cochran-Mantel-Haenszel|CMH test was stratified by study site.||Independent assessed DCR||||>0.05
72611477|NCT00274456|144751492|SUPERIORITY_OR_OTHER_LEGACY|||||||0.085|||||||Cochran-Mantel-Haenszel|CMH test was stratified by study site.||Independent assessed DCR||||0.085
72611478|NCT00274456|144751492|SUPERIORITY_OR_OTHER_LEGACY|||||||0.007||||||"A step-down approach was used to compare treatment regimens. First an overall test of treatment difference (a 3-degree-of -freedom test) was performed. Pairwise comparison was performed only if this test was significant."|Cochran-Mantel-Haenszel|CMH test was stratified by study site.||Investigator assessed disease control rate (DCR), ie, SD \>= 16 weeks, or CR or PR||||0.007
72611479|NCT00274456|144751492|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05||95.0|||||Cochran-Mantel-Haenszel|CMH test was stratified by study site.||Investigator assessed DCR||||>0.05
72611480|NCT00274456|144751492|SUPERIORITY_OR_OTHER_LEGACY|||||||0.009|||||||Cochran-Mantel-Haenszel|CMH test was stratified by study site.||Investigator assessed DCR||||0.009
72326568|NCT00251693|144176258|SUPERIORITY_OR_OTHER|||||||0.707||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Cochran-Mantel-Haenszel|||||||0.707
72611481|NCT00274456|144751492|SUPERIORITY_OR_OTHER_LEGACY|||||||0.005|TWO_SIDED||||||Cochran-Mantel-Haenszel|CMH test was stratified by study site.||Investigator assessed DCR||||0.005
72611482|NCT00274456|144751492|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|||||||Cochran-Mantel-Haenszel|CMH test was stratified by study site.||Investigator assessed DCR||||>0.05
72611483|NCT00274456|144751492|SUPERIORITY_OR_OTHER_LEGACY|||||||0.098||95.0|||||Cochran-Mantel-Haenszel|CMH test was stratified by study site.||Investigator assessed DCR||||0.098
72611484|NCT00274456|144751492|SUPERIORITY_OR_OTHER_LEGACY|||||||0.014||95.0|||||Cochran-Mantel-Haenszel|CMH test was stratified by study site.||Investigator assessed DCR||||0.014
72611485|NCT00274456|144751493|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0498||||||"A step-down approach was used to compare treatment regimens. First an overall test of treatment difference (a 3-degree-of -freedom test) was performed. Pairwise comparisons were performed only if this test was significant."|Log Rank|||Independent assessment||||0.0498
72611486|NCT00274456|144751493|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.607||||0.0524|||||||Log Rank|||Independent assessment||||0.0524
72611487|NCT00274456|144751493|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.495||||0.0065|||||||Log Rank|||Independent assessment||||0.0065
72611488|NCT00274456|144751493|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|||||||Log Rank|||Independent assessment||||>0.05
72611489|NCT00274456|144751493|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|||||||Log Rank|||Independent assessment||||>0.05
72611490|NCT00274456|144751493|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|||||||Log Rank|||Independent assessment||||>0.05
72418815|NCT01274182|144347846|EQUIVALENCE|The PK parameters were transformed prior to analysis using a logarithmic transformation. An analysis of variance (ANOVA) was used to analyze the transformed data including treatment group only as a factor in the model. The confidence interval for the difference between the two products on the transformed scale was obtained from the ANOVA model, which was then be back-transformed (exp base e) to obtain the confidence interval for the ratio on the original scale.|Geometric mean ratio|1.012|||||TWO_SIDED|90.0|0.925|1.108|||||GP2013 arm is the numerator and Rituxan arm is the denominator|PK bioequivalence is defined as AUC(0-inf) of the drugs being comparable, i.e. the two-sided 90% CI for the ratio of the geometric means (GP2013/MabThera) is within the predefined bioequivalence limits of 0.8 to 1.25.||1.108|0.925|
72418816|NCT01274182|144347846|EQUIVALENCE|The PK parameters were transformed prior to analysis using a logarithmic transformation. An analysis of variance (ANOVA) was used to analyze the transformed data including treatment group only as a factor in the model. The confidence interval for the difference between the two products on the transformed scale was obtained from the ANOVA model, which was then be back-transformed (exp base e) to obtain the confidence interval for the ratio on the original scale.|Geometric mean ratio|1.093|||||TWO_SIDED|90.0|0.989|1.208|||||Rituxan arm is the numerator and MabThera arm is the denominator|PK bioequivalence is defined as AUC(0-inf) of the drugs being comparable, i.e. the two-sided 90% CI for the ratio of the geometric means (GP2013/MabThera) is within the predefined bioequivalence limits of 0.8 to 1.25.||1.208|0.989|
72418817|NCT01274182|144347847|EQUIVALENCE|The PK parameters were transformed prior to analysis using a logarithmic transformation. An analysis of variance (ANOVA) was used to analyze the transformed data including treatment group only as a factor in the model. The confidence interval for the difference between the two products on the transformed scale was obtained from the ANOVA model, which was then be back-transformed (exp base e) to obtain the confidence interval for the ratio on the original scale.|Geometric mean ratio|1.076|||||TWO_SIDED|90.0|0.979|1.184|||||GP2013 arm is the numerator and Rituxan arm is the denominator|To conclude bioequivalence the 90% CI must be entirely within the standard equivalence limits of 0.8-1.25.||1.184|0.979|
72418818|NCT01274182|144347847|EQUIVALENCE|The PK parameters were transformed prior to analysis using a logarithmic transformation. An analysis of variance (ANOVA) was used to analyze the transformed data including treatment group only as a factor in the model. The confidence interval for the difference between the two products on the transformed scale was obtained from the ANOVA model, which was then be back-transformed (exp base e) to obtain the confidence interval for the ratio on the original scale.|Geometric mean ratio|1.131|||||TWO_SIDED|90.0|1.027|1.244|||||GP2013 arm is the numerator and MabThera arm is the denominator|To conclude bioequivalence the 90% CI must be entirely within the standard equivalence limits of 0.8-1.25||1.244|1.027|
72418819|NCT01274182|144347847|EQUIVALENCE|The PK parameters were transformed prior to analysis using a logarithmic transformation. An analysis of variance (ANOVA) was used to analyze the transformed data including treatment group only as a factor in the model. The confidence interval for the difference between the two products on the transformed scale was obtained from the ANOVA model, which was then be back-transformed (exp base e) to obtain the confidence interval for the ratio on the original scale.|Geometric mean ratio|1.05|||||TWO_SIDED|90.0|0.946|1.167|||||Rituxan arm is the numerator and MabThera arm is the denominator|To conclude bioequivalence the 90% CI must be entirely within the standard equivalence limits of 0.8-1.25.||1.167|0.946|
72418820|NCT01274182|144347848|EQUIVALENCE|Ratio of geometric means and 95% confidence interval were estimated by an analysis of variance (ANOVA) on log-transformed PD parameter with treatment as the factor. Results were then back-transformed to the original scale.|Geometric mean ratio|0.989|||||TWO_SIDED|95.0|0.974|1.004|||||GP2013 arm is the numerator and Rituxan arm is the denominator|To conclude equivalence the 95% CI must be entirely within the standard equivalencelimits of 0.8-1.25||1.004|0.974|
72418821|NCT01274182|144347848|EQUIVALENCE|Ratio of geometric means and 95% confidence interval were estimated by an analysis of variance (ANOVA) on log-transformed PD parameter with treatment as the factor. Results were then back-transformed to the original scale.|Geometric mean ratio|1.021|||||TWO_SIDED|95.0|1.003|1.04|||||GP2013 arm is the numerator and MabThera arm is the denominator|To conclude equivalence the 95% CI must be entirely within the standard equivalencelimits of 0.8-1.25||1.040|1.003|
72418822|NCT01274182|144347848|EQUIVALENCE|Ratio of geometric means and 95% confidence interval were estimated by an analysis of variance (ANOVA) on log-transformed PD parameter with treatment as the factor. Results were then back-transformed to the original scale.|Geometric mean ratio|1.033|||||TWO_SIDED|95.0|1.016|1.05|||||Rituxan arm is the numerator and MabThera arm is the denominator|To conclude equivalence the 95% CI must be entirely within the standard equivalence limits of 0.8-1.25||1.050|1.016|
72418823|NCT01274182|144347849|NON_INFERIORITY|"The non-inferiority margin is further justified by the EULAR criteria which define no response as change from baseline being \< 0.6.~LS means, standard errors and 95% CI were estimated by a repeated measures mixed model with treatment, time and treatment\*time interaction term as categorical variables and baseline DAS28 as a continuous variable.~A negative change from baseline represents an improvement in assessment of rheumatoid arthritis."|LS Mean difference|-0.08|STANDARD_ERROR_OF_MEAN|0.162|||TWO_SIDED|95.0|-0.397|0.24|||||The direction of comparison is LS mean of GP2013 - LS mean of Rituxan|To conclude non-inferiority the upper 95% CI should be less than or equal to 0.6. This margin was statistically justified by the results of the REFLEX (Randomized Evaluation of Long-Term Efficacy of Rituximab in RA) trial (Cohen et al 2006) providing a 95% CI for the mean difference between rituximab/MTX and MTX alone of (-1.74;-1.25). The margin of 0.6 was determined by retaining more than 50% of the reference treatment effect which was considered clinically acceptable.||0.240|-0.397|
72611491|NCT00274456|144751493|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|||||||Log Rank|||Independent assessment||||>0.05
72611492|NCT00274456|144751493|SUPERIORITY_OR_OTHER_LEGACY|||||||0.008||||||"A step-down approach was used to compare treatment regimens. First an overall test of treatment difference (a 3-degree-of -freedom test) was performed. Pairwise comparisons was performed only if this test was significant."|Log Rank|||Investigator assessment||||0.008
72611493|NCT00274456|144751493|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|||||||Log Rank|||Investigator assessment||||>0.05
72611494|NCT00274456|144751493|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|||||||Log Rank|||Investigator assessment||||>0.05
72611495|NCT00274456|144751493|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.568||||0.012|||||||Log Rank|||Investigator assessment||||0.012
72611496|NCT00274456|144751493|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.972||||0.001|||||||Log Rank|||Investigator assessment||||0.001
72611497|NCT00274456|144751493|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.702||||0.076|||||||Log Rank|||Investigator assessment||||0.076
72611498|NCT00274456|144751493|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|||||||Log Rank|||Investigator assessment||||>0.05
72611499|NCT00274456|144751494|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05||||||"A step-down approach was used to compare treatment regimens. First an overall test of treatment difference (a 3-degree-of -freedom test) was performed. Pairwise comparisons was performed only if this test was significant."|Log Rank|||Independent assessment||||>0.05
72611500|NCT00274456|144751495|SUPERIORITY_OR_OTHER_LEGACY|||||||0.013||||||"A step-down approach was used to compare treatment regimens. First an overall test of treatment difference (a 3-degree-of -freedom test) was performed. Pairwise comparisons was performed only if this test was significant."|Log Rank|||Investigator assessment||||0.013
72611501|NCT00274456|144751495|SUPERIORITY_OR_OTHER_LEGACY|||||||0.022|||||||Log Rank|||Investigator assessment||||0.022
72611502|NCT00274456|144751495|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|||||||Log Rank|||Investigator assessment||||>0.05
72611503|NCT00274456|144751495|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|||||||Log Rank|||Investigator assessment||||>0.05
72611504|NCT00274456|144751495|SUPERIORITY_OR_OTHER_LEGACY|||||||0.005|||||||Log Rank|||Investigator assessment||||0.005
72611505|NCT00274456|144751495|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|||||||Log Rank|||Investigator assessment||||>0.05
72611506|NCT00274456|144751495|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|||||||Log Rank|||Investigator assessment||||>0.05
72418824|NCT01274182|144347849|NON_INFERIORITY|"The non-inferiority margin is further justified by the EULAR criteria which define no response as change from baseline being \< 0.6. LS means, standard errors and 95% CI were estimated by a repeated measures mixed model with treatment, time and treatment\*time interaction term as categorical variables and baseline DAS28 as a continuous variable.~A negative change from baseline represents an improvement in assessment of rheumatoid arthritis."|LS Mean difference|0.07|STANDARD_ERROR_OF_MEAN|0.201|||TWO_SIDED|95.0|-0.328|0.462|||||The direction of comparison is LS mean of GP2013 Part I - LS mean of MabThera|To conclude non-inferiority the upper 95% CI should be less than or equal to 0.6. This margin was statistically justified by the results of the REFLEX (Randomized Evaluation of Long-Term Efficacy of Rituximab in RA) trial (Cohen et al 2006) providing a 95% CI for the mean difference between rituximab/MTX and MTX alone of (-1.74;-1.25). The margin of 0.6 was determined by retaining more than 50% of the reference treatment effect which was considered clinically acceptable.||0.462|-0.328|
72418825|NCT01274182|144347850|NON_INFERIORITY|The predefined noninferiority margin of 0.15 for ACR20 is based on the historical placebo-controlled phase III study to evaluate the response rate benefit of adding rituximab to the conventional small molecule-based treatment of patients with RA (Cohen et al. 2006).|Response rate difference (%)|9.77|STANDARD_ERROR_OF_MEAN|6.79|||TWO_SIDED|95.0|-3.54|23.08|||||The direction of comparison is response rate of GP2013 - response rate of Rituxan|To conclude non-inferiority the lower 95% CI should be greater than -15.0%.||23.08|-3.54|
72418826|NCT01274182|144347850|NON_INFERIORITY|The predefined noninferiority margin of 0.15 for ACR20 is based on the historical placebo-controlled phase III study to evaluate the response rate benefit of adding rituximab to the conventional small molecule-based treatment of patients with RA (Cohen et al. 2006).|Response rate difference (%)|-0.57|STANDARD_ERROR_OF_MEAN|7.23|||TWO_SIDED|95.0|-14.74|13.6|||||The direction of comparison is response rate of GP2013 Part I - response rate of MabThera|To conclude non-inferiority the lower 95% CI should be greater than -15.0%.||13.60|-14.74|
72418827|NCT04322604|144347868|SUPERIORITY||Percent Difference from Placebo|80.1|||<|0.0001|TWO_SIDED|95.0|70.1|87.9|||Fisher Exact|||||87.9|70.1|<0.0001
72418828|NCT04322604|144347869|SUPERIORITY||LSM Difference from Placebo|1.5||||0.3427|TWO_SIDED|95.0|-1.6|4.7|||ANCOVA|||||4.7|-1.6|0.3427
72418829|NCT04322604|144347870|SUPERIORITY||LSM Difference from Placebo|-41.2|||<|0.0001|TWO_SIDED|95.0|-48.1|-34.2|||ANCOVA|||||-34.2|-48.1|<0.0001
72611507|NCT00274456|144751496|SUPERIORITY_OR_OTHER_LEGACY|||||||0.047||95.0||||"A step-down approach was used to compare treatment regimens. First an overall test of treatment difference (a 3-degree-of -freedom test) was performed. Pairwise comparisons were performed only if this test was significant."|Log Rank|||||||0.047
72611508|NCT00274456|144751496|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05||95.0|||||Log Rank|||||||>0.05
72611509|NCT00274456|144751496|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05||95.0|||||Log Rank|||||||>0.05
72611510|NCT00274456|144751496|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05||95.0|||||Log Rank|||||||>0.05
72611511|NCT00274456|144751496|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.686||||0.069||95.0|||||Log Rank|||||||0.069
72611512|NCT00274456|144751496|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05||95.0|||||Log Rank|||||||>0.05
72418830|NCT04322604|144347871|SUPERIORITY||Percent Difference from Placebo|81.3|||<|0.0001|TWO_SIDED|95.0|71.7|88.8|||Fisher Exact|||||88.8|71.7|<0.0001
72418831|NCT04322604|144347872|SUPERIORITY||Percent Difference from Placebo|39.5|||<|0.0001|TWO_SIDED|95.0|25.4|52.2|||Fisher Exact|||||52.2|25.4|<0.0001
72418832|NCT04322604|144347873|SUPERIORITY||Percent Difference from Placebo|7.0||||0.3549|TWO_SIDED|95.0|-7.4|21.6|||Fisher Exact|||||21.6|-7.4|0.3549
72611513|NCT00274456|144751496|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.74||||0.008||95.0|||||Log Rank|||||||0.008
72611514|NCT02314546|144751500|SUPERIORITY_OR_OTHER|||||||0.99|TWO_SIDED||||||Chi-squared|||||||0.99
72611515|NCT02314546|144751501|SUPERIORITY_OR_OTHER|||||||0.99|TWO_SIDED||||||Chi-squared|||||||0.99
72611516|NCT02314546|144751502|SUPERIORITY_OR_OTHER|||||||0.26|TWO_SIDED||||||Kruskal-Wallis|||||||0.26
72418833|NCT04322604|144347874|SUPERIORITY||Percent Difference from Placebo|8.3||||0.2262|TWO_SIDED|95.0|-6.3|22.7|||Fisher Exact|||||22.7|-6.3|0.2262
72611517|NCT02314546|144751503|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED||||||Kruskal-Wallis|||||||0.02
72611518|NCT02314546|144751504|SUPERIORITY_OR_OTHER|||||||0.04|TWO_SIDED||||||Kruskal-Wallis|||||||0.04
72611519|NCT02314546|144751505|SUPERIORITY_OR_OTHER|||||||0.73|TWO_SIDED||||||Chi-squared|||||||0.73
72611520|NCT02314546|144751506|SUPERIORITY_OR_OTHER|||||||0.73|TWO_SIDED||||||Chi-squared|||||||0.73
72611521|NCT00375752|144751526|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|14.7||||0.106|TWO_SIDED|95.0|-1.8|31.1|||Fisher Exact|||||31.1|-1.8|0.106
72611522|NCT02034006|144751531|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|72.37|||<|0.0001|TWO_SIDED|95.0|23.44|223.42|||Regression, Logistic|||Presence vs. absence of active leakage.||223.42|23.44|<0.0001
72611523|NCT02034006|144751537|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|9.33|||<|0.0001|TWO_SIDED|95.0|3.18|27.36|||Regression, Logistic|||Presence vs. absence of macular edema.||27.36|3.18|<0.0001
72611524|NCT02034006|144751538|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|12.66|||<|0.0001|TWO_SIDED|95.0|3.76|42.67|||Regression, Logistic|||Presence vs. absence of cysts.||42.67|3.76|<0.0001
72611525|NCT02034006|144751539|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|49.8|||<|0.0001|TWO_SIDED|95.0|11.62|213.5|||Regression, Logistic|||Presence vs. absence of intra-retinal fluid.||213.50|11.62|<0.0001
72611526|NCT02034006|144751540|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.0||||0.1514|TWO_SIDED|95.0|0.99|1.0|||Regression, Logistic|||Change in Central subfield thickness vs previous visit.||1.00|0.99|0.1514
72611527|NCT02034006|144751541|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.0||||0.1265|TWO_SIDED|95.0|0.0|5.63|||Regression, Logistic|||Change in Central subfield volume vs previous visit.||5.63|0.00|0.1265
72611528|NCT02034006|144751543|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.91||||0.0103|TWO_SIDED|95.0|1.58|30.23|||Regression, Logistic|||Presence vs. absence of clinically significant abnormalities.||30.23|1.58|0.0103
72611529|NCT02034006|144751544|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.19||||0.0854|TWO_SIDED|95.0|0.9|5.33|||Regression, Logistic|||Gain \< 5 letters vs. Gain \>= 5 letters.||5.33|0.90|0.0854
72418834|NCT04322604|144347875|SUPERIORITY||LSM Difference from Placebo|5.0||||0.3812|TWO_SIDED|95.0|-6.1|16.0|||Mixed Models Analysis|||Week 24 Percent Change from Baseline||16.0|-6.1|0.3812
72611530|NCT02034006|144751545|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.52||||0.0114|TWO_SIDED|95.0|1.23|5.17|||Regression, Logistic|||Gain \< 10 letters vs. Gain \>= 10 letters.||5.17|1.23|0.0114
72611531|NCT02034006|144751546|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.47||||0.0049|TWO_SIDED|95.0|0.25|0.91|||Regression, Logistic|||Change from baseline in BCVA: Improved vs. No change. For retreated subjects, the last scheduled assessment prior to the first retreatment was considered. For subjects treated only once, the last scheduled assessment available was considered.||0.91|0.25|0.0049
72611532|NCT02034006|144751546|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.53||||0.0461|TWO_SIDED|95.0|0.69|44.52|||Regression, Logistic|||Change from baseline in BCVA: Worsened vs. No change||44.52|0.69|0.0461
72611533|NCT00576758|144751619|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.26||||0.1587|TWO_SIDED|60.0|3.9|18.7|||Chi-squared|||||18.7|3.9|0.1587
72611534|NCT00576758|144751620|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.83|||||TWO_SIDED|95.0|-2.9|16.6||||||||16.6|-2.9|
72611535|NCT00576758|144751624|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.22|||||TWO_SIDED|95.0|-13.9|18.3||||||||18.3|-13.9|
72611536|NCT00576758|144751625|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.93|||||TWO_SIDED|95.0|0.62|1.44||||||||1.44|0.62|
72611537|NCT00576758|144751627|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.0|||||TWO_SIDED|95.0|0.67|1.5||||||||1.50|0.67|
72611538|NCT01499511|144751693|SUPERIORITY|||||||0.624|||||||ANOVA|||||||0.624
72611539|NCT01499511|144751694|SUPERIORITY|||||||0.004|||||||ANOVA|||||||0.004
72611540|NCT01499511|144751695|SUPERIORITY|||||||0.304|||||||ANOVA|||||||0.304
72611541|NCT01499511|144751696|SUPERIORITY|||||||0.641|||||||ANOVA|||||||0.641
72611542|NCT01499511|144751697|SUPERIORITY|||||||0.915|||||||ANOVA|||||||0.915
72611543|NCT00853385|144751711|SUPERIORITY_OR_OTHER||Percent difference|24.24|||<|0.0001|TWO_SIDED|95.0|13.18|35.31||A step-down procedure was used to control for multiple comparisons. In order for the comparison to 5 mg to be statistically significant, the comparison to 10 mg had to be statistically significant.|Normal approximation|||Normal approximation for the difference in binomial proportions was used to test the superiority of CP-690,550 10 mg to placebo and 2-sided 95% confidence interval (CI) was evaluated for the difference in percentages.||35.31|13.18|<0.0001
72611544|NCT00853385|144751711|SUPERIORITY_OR_OTHER||Percent difference|23.22|||<|0.0001|TWO_SIDED|95.0|12.16|34.29||A step-down procedure was used to control for multiple comparisons. In order for the comparison to 5 mg to be statistically significant, the comparison to 10 mg had to be statistically significant.|Normal approximation|||Normal approximation for the difference in binomial proportions was used to test the superiority of CP-690,550 5 mg to placebo and 2-sided 95% CI was evaluated for the difference in percentages.||34.29|12.16|<0.0001
72611545|NCT00853385|144751711|SUPERIORITY_OR_OTHER||Percent difference|18.93||||0.0007|TWO_SIDED|95.0|7.9|29.96||Statistical testing was done at 5% significance level (2-sided).|Normal approximation|||Normal approximation for the difference in binomial proportions was used to test the superiority of adalimumab to placebo and 2-sided 95% CI was evaluated for the difference in percentages.||29.96|7.90|0.0007
72611546|NCT00853385|144751712|SUPERIORITY_OR_OTHER||LS mean difference|-0.38|STANDARD_ERROR_OF_MEAN|0.06|<|0.0001|TWO_SIDED|95.0|-0.5|-0.25||A step-down procedure was used to control for multiple comparisons. For the comparison of 10 mg to placebo to be statistically significant in this measure, the comparison of 10 mg to placebo in ACR20 had to be significant.|Mixed Models Analysis|||Least squares (LS) mean difference and corresponding 95% CI was calculated using a mixed-effect repeated measure model with treatment, visit and treatment-by-visit interaction as fixed effect and participant as random effect.||-0.25|-0.50|<0.0001
72611547|NCT00853385|144751712|SUPERIORITY_OR_OTHER||LS mean difference|-0.31|||<|0.0001|TWO_SIDED|95.0|-0.43|-0.19||Step-down procedure: For the comparison of 5 mg to placebo to be statistically significant in this measure, the comparison of 10 mg to placebo as well as the comparison of 5 mg to placebo in ACR20 had to be statistically significant.|Mixed Models Analysis|||LS mean difference and corresponding 95% CI was calculated using a mixed-effect repeated measure model with treatment, visit and treatment-by-visit interaction as fixed effect and participant as random effect.||-0.19|-0.43|<0.0001
72611548|NCT00853385|144751712|SUPERIORITY_OR_OTHER||LS mean difference|-0.25|||<|0.0001|TWO_SIDED|95.0|-0.37|-0.13||Statistical testing was done at 5% significance level (2-sided).|Mixed Models Analysis|||LS mean difference and corresponding 95% CI was calculated using a mixed-effect repeated measure model with treatment, visit and treatment-by-visit interaction as fixed effect and participant as random effect.||-0.13|-0.37|<0.0001
72418835|NCT00420992|144347880|SUPERIORITY_OR_OTHER|||||||0.0445||95.0||||Threshold for statistical significance: P=0.05. No adjustment for multiple comparisons necessary.|ANCOVA|Model included treatment as factor and baseline pain score as covariate.||Null hypothesis: mean change from baseline is the same for ALO-01 and placebo.||||0.0445
72418836|NCT03882879|144347907|SUPERIORITY|||||||0.64|||||||t-test, 2 sided|||||||0.64
72418837|NCT03882879|144347908|SUPERIORITY|||||||0.53|||||||t-test, 2 sided|||||||0.53
72418838|NCT03882879|144347909|SUPERIORITY|||||||0.76||||||Between-group two-sided t-test|t-test, 2 sided|||||||0.76
72418839|NCT03882879|144347910|SUPERIORITY|||||||0.49|||||||t-test, 2 sided|||||||0.49
72418840|NCT03882879|144347911|SUPERIORITY|||||||0.2|||||||t-test, 2 sided|||||||0.20
72418841|NCT03923959|144347928|SUPERIORITY||Odds Ratio (OR)|1.013|STANDARD_ERROR_OF_MEAN|0.307||0.966|TWO_SIDED|95.0|0.5597|1.834|||Regression, Logistic||||A two-sample proportion test was also completed; the test utilized an α \< 0.049 to account for the O'Brien-Fleming adjustment. The p-value for the two-sample proportion test was 0.966.|1.834|0.5597|0.966
72418842|NCT03923959|144347929|SUPERIORITY|||||||0.183||||||a priori threshold for statistical significance was the standard α = 0.05.|Chi-squared|||||||0.183
72418843|NCT03923959|144347930|SUPERIORITY|||||||0.729||||||a priori threshold for statistical significance was the standard α = 0.05.|Chi-squared|||||||0.729
72418844|NCT03923959|144347931|SUPERIORITY|||||||0.655||||||a priori threshold for statistical significance was the standard α = 0.05|Chi-squared|||||||0.655
72418845|NCT03923959|144347932|SUPERIORITY|||||||0.7832||||||a priori threshold for statistical significance was the standard α = 0.05.|t-test, 2 sided|||||||0.7832
72418846|NCT02954354|144347960|SUPERIORITY||Difference|-26.5|||<|0.0001|TWO_SIDED|95.0|-35.8|-17.8||Adjusted p-value, two-sided significance level of 0.05|Generalized Wilcoxon test|Generalized Wilcoxon test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||The primary analysis of time to alleviation of symptoms was a comparison of baloxavir with placebo in all participants in the intention-to-treat infection population. Statistical tests were performed at the 0.05 significance level.||-17.8|-35.8|<0.0001
72418847|NCT02954354|144347960|SUPERIORITY||||||<|0.0001||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Log Rank|Log rank test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Analysis using the stratified log rank test was performed as a sensitivity analysis.||||<0.0001
72418848|NCT02954354|144347961|SUPERIORITY||Difference|-0.3||||0.756|TWO_SIDED|95.0|-6.6|6.6||Adjusted p-value, two-sided significance level of 0.05|Generalized Wilcoxon test|Generalized Wilcoxon test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||A secondary analysis of time to alleviation of symptoms, consisting of a comparison between the 20 to 64 years of age stratum of the baloxavir group and the oseltamivir group, was conducted if statistical significance was observed in the primary analysis in order to maintain the overall Type I error.||6.6|-6.6|0.7560
72418849|NCT02954354|144347961|SUPERIORITY|||||||0.3761||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Log Rank|Log rank test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Analysis using the stratified log rank test was performed as a sensitivity analysis.||||0.3761
72418850|NCT02954354|144347962|SUPERIORITY||||||<|0.0001||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 2||||<0.0001
72418851|NCT02954354|144347962|SUPERIORITY||||||<|0.0001||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 3||||<0.0001
72418852|NCT02954354|144347962|SUPERIORITY||||||<|0.0001||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 4||||<0.0001
72418853|NCT02954354|144347962|SUPERIORITY||||||<|0.0001||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 5||||<0.0001
72418854|NCT02954354|144347962|SUPERIORITY|||||||0.4767||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 6||||0.4767
72418855|NCT02954354|144347962|SUPERIORITY|||||||0.3353||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 9||||0.3353
72418856|NCT02954354|144347963|SUPERIORITY||||||<|0.0001||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 2||||<0.0001
72418857|NCT02954354|144347963|SUPERIORITY||||||<|0.0001||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 3||||<0.0001
72418858|NCT02954354|144347963|SUPERIORITY|||||||0.0852||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 4||||0.0852
72418859|NCT02954354|144347963|SUPERIORITY|||||||0.0063||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 5||||0.0063
72418860|NCT02954354|144347963|SUPERIORITY|||||||0.6187||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 6||||0.6187
72418861|NCT02954354|144347963|SUPERIORITY|||||||0.8637||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|||Day 9||||0.8637
72418862|NCT02954354|144347964|SUPERIORITY|||||||0.6145||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 2||||0.6145
72418863|NCT02954354|144347964|SUPERIORITY|||||||0.2505||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 3||||0.2505
72611549|NCT00853385|144751713|SUPERIORITY_OR_OTHER||Percent difference|11.41|||<|0.0001|TWO_SIDED|95.0|6.08|16.73||A step-down procedure was used to control for multiple comparisons. For comparison of 10 mg to placebo to be statistically significant in this measure, comparison of 10 mg to placebo in HAQ-DI had to be significant.|Normal approximation|||Normal approximation to the binomial distribution was used to test the superiority of CP-690,550 10 mg to placebo and two-sided 95% CI was evaluated for the difference in percentages.||16.73|6.08|<0.0001
72611550|NCT00853385|144751713|SUPERIORITY_OR_OTHER||Percent difference|5.12||||0.0151|TWO_SIDED|95.0|0.98|9.26||Step-down procedure: For the comparison of 5 mg to placebo to be statistically significant in this measure, the comparison of 10 mg to placebo as well as comparison of 5 mg to placebo in HAQ-DI had to be statistically significant.|Normal approximation|||Normal approximation for the difference in binomial proportions was used to test the superiority of CP-690,550 5 mg to placebo and 2-sided 95% CI was evaluated for the difference in percentages.||9.26|0.98|0.0151
72611551|NCT00853385|144751713|SUPERIORITY_OR_OTHER||Percent difference|5.65||||0.0091|TWO_SIDED|95.0|1.4|9.9||Statistical testing was done at 5% significance level (2-sided).|Normal approximation|||Normal approximation for the difference in binomial proportions was used to test the superiority of adalimumab to placebo and 2-sided 95% CI was evaluated for the difference in percentages.||9.90|1.40|0.0091
72611552|NCT01107015|144751799|OTHER|Sample size was determined on the basis of the primary outcome, change in glycated hemoglobin. The comparison of UC, which included 56 patients from nine practices, to CPDS, which included 62 patients from seven practices, had 80% power to detect a difference in mean glycated hemoglobin changes of 0.65 SD, corresponding to 1.0% if SD was 1.58%, using a two-sided test with 0.05 type I error after accounting for a within cluster correlation of 0.10.||||||0.027||||||CO (P = 0.027) and CPP (0.40) mean HbA1c levels decreased over 12 months.|Mixed Models Analysis|||Linear mixed-effects models were used to compare mean changes in primary and secondary outcomes between UC and each active intervention. The primary analysis examined 12-month changes for glycated hemoglobin. Secondary analyses jointly compared 3-, 6-, 9-, and 12-month changes between groups. Random effects accounted for within-practice clustering and within-patient correlation.||||0.027
72611553|NCT01107015|144751799|SUPERIORITY||Mean Difference (Net)|0.05||||0.001|TWO_SIDED||||||Mixed Models Analysis|||Linear mixed-effects models were used to compare mean changes in primary and secondary outcomes between UC and each active intervention. The primary analysis examined 12-month changes for glycated hemoglobin.||||0.001
72611554|NCT02765035|144751800|SUPERIORITY|||||||0.01|||||||t-test, 1 sided|||C-Leg 3 vs. NMPK (Baseline)||||0.01
72611555|NCT02765035|144751800|SUPERIORITY|||||||0.04|||||||t-test, 1 sided|||C-Leg 4 vs. NMPK (Baseline)||||0.04
72611556|NCT03104413|144751810|SUPERIORITY||Adjusted Risk Difference|22.1|||<|0.001|TWO_SIDED|95.0|13.1|31.0|||Cochran-Mantel-Haenszel|||||31.0|13.1|<0.001
72611557|NCT03104413|144751810|SUPERIORITY||Adjusted Risk Difference|20.5|||<|0.001|TWO_SIDED|95.0|11.6|29.5|||Cochran-Mantel-Haenszel|||||29.5|11.6|< 0.001
72611558|NCT03104413|144751811|SUPERIORITY||Adjusted Risk Difference|17.6|||<|0.001|TWO_SIDED|95.0|9.9|25.4|||Cochran-Mantel-Haenszel|||||25.4|9.9|< 0.001
72611559|NCT03104413|144751811|SUPERIORITY||Adjusted Risk Difference|23.1|||<|0.001|TWO_SIDED|95.0|15.1|31.1|||Cochran-Mantel-Haenszel|||||31.1|15.1|<0.001
72611560|NCT03104413|144751812|SUPERIORITY||Adjusted Risk Difference|17.6|||<|0.001|TWO_SIDED|95.0|9.9|25.4|||Cochran-Mantel-Haenszel|||||25.4|9.9|<0.001
72611561|NCT03104413|144751812|SUPERIORITY||Adjusted Risk Difference|23.1|||<|0.001|TWO_SIDED|95.0|15.1|31.1|||Cochran-Mantel-Haenszel|||||31.1|15.1|<0.001
72326569|NCT00251693|144176259|SUPERIORITY_OR_OTHER|||||||0.705||95.0||||Unadjusted p-value is presented. Statistical significance was determined at 0.05 level by Hommel-Simes method within treatment and Hochberg method for comparisons of each dexlansoprazole dose to lansoprazole.|Cochran-Mantel-Haenszel|||||||0.705
72611562|NCT03104413|144751813|SUPERIORITY||Adjusted Risk Difference|15.2||||0.001|TWO_SIDED|95.0|6.4|24.0|||Cochran-Mantel-Haenszel|||||24.0|6.4|0.001
72611563|NCT03104413|144751813|SUPERIORITY||Adjusted Risk Difference|20.4|||<|0.001|TWO_SIDED|95.0|11.5|29.3|||Cochran-Mantel-Haenszel|||||29.3|11.5|<0.001
72611564|NCT03104413|144751814|SUPERIORITY||Adjusted Risk Difference|15.7||||0.001|TWO_SIDED|95.0|6.8|24.6|||Cochran-Mantel-Haenszel|||||24.6|6.8|0.001
72611565|NCT03104413|144751814|SUPERIORITY||Adjusted Risk Difference|11.8||||0.008|TWO_SIDED|95.0|3.0|20.5|||Cochran-Mantel-Haenszel|||||20.5|3.0|0.008
72611566|NCT03104413|144751815|SUPERIORITY||Adjusted Risk Difference|29.4|||<|0.001|TWO_SIDED|95.0|19.9|39.0|||Cochran-Mantel-Haenszel|||||39.0|19.9|< 0.001
72611567|NCT03104413|144751815|SUPERIORITY||Adjusted Risk Difference|30.6|||<|0.001|TWO_SIDED|95.0|21.1|40.1|||Cochran-Mantel-Haenszel|||||40.1|21.1|<0.001
72611568|NCT03104413|144751816|SUPERIORITY||LS Mean Difference|2.8||||0.02|TWO_SIDED|95.0|0.4|5.1|||Mixed-Effect Model Repeat Measurement|||||5.1|0.4|0.020
72611569|NCT03104413|144751816|SUPERIORITY||LS Mean Difference|3.0||||0.01|TWO_SIDED|95.0|0.7|5.3|||Mixed-Effect Model Repeat Measurement|||||5.3|0.7|0.010
72611570|NCT03104413|144751817|SUPERIORITY||Adjusted Risk Difference|9.6||||0.01|TWO_SIDED|95.0|2.3|16.9|||Cochran-Mantel-Haenszel|||||16.9|2.3|0.010
72611571|NCT03104413|144751817|SUPERIORITY||Adjusted Risk Difference|8.2||||0.023|TWO_SIDED|95.0|1.1|15.3|||Cochran-Mantel-Haenszel|||||15.3|1.1|0.023
72611572|NCT03104413|144751818|SUPERIORITY||Adjusted Risk Difference|15.0|||<|0.001|TWO_SIDED|95.0|8.5|21.5|||Cochran-Mantel-Haenszel|||||21.5|8.5|<0.001
72611573|NCT03104413|144751818|SUPERIORITY||Adjusted Risk Difference|17.8|||<|0.001|TWO_SIDED|95.0|11.1|24.5|||Cochran-Mantel-Haenszel|||||24.5|11.1|<0.001
72611574|NCT03104413|144751819|SUPERIORITY||Adjusted Risk Difference|17.5|||<|0.001|TWO_SIDED|95.0|8.0|26.9|||Cochran-Mantel-Haenszel|||||26.9|8.0|<0.001
72611575|NCT03104413|144751819|SUPERIORITY||Adjusted Risk Difference|20.3|||<|0.001|TWO_SIDED|95.0|10.8|29.8|||Cochran-Mantel-Haenszel|||||29.8|10.8|<0.001
72611576|NCT03104413|144751820|SUPERIORITY||Adjusted Risk Difference|21.8|||<|0.001|TWO_SIDED|95.0|12.1|31.6|||Cochran-Mantel-Haenszel|||||31.6|12.1|<0.001
72611577|NCT03104413|144751820|SUPERIORITY||Adjusted Risk Difference|22.7|||<|0.001|TWO_SIDED|95.0|13.0|32.5|||Cochran-Mantel-Haenszel|||||32.5|13.0|<0.001
72418864|NCT02954354|144347964|SUPERIORITY|||||||0.419||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 4||||0.4190
72418865|NCT02954354|144347964|SUPERIORITY|||||||0.0095||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 5||||0.0095
72611578|NCT03104413|144751821|SUPERIORITY||Adjusted Risk Difference|15.0|||<|0.001|TWO_SIDED|95.0|8.9|21.2|||Cochran-Mantel-Haenszel|||||21.2|8.9|<0.001
72611579|NCT03104413|144751821|SUPERIORITY||Adjusted Risk Difference|16.2|||<|0.001|TWO_SIDED|95.0|9.9|22.4|||Cochran-Mantel-Haenszel|||||22.4|9.9|<0.001
72611580|NCT03104413|144751822|SUPERIORITY||Adjusted Risk Difference|13.6||||0.006|TWO_SIDED|95.0|4.0|23.3|||Cochran-Mantel-Haenszel|||||23.3|4.0|0.006
72611581|NCT03104413|144751822|SUPERIORITY||Adjusted Risk Difference|7.1||||0.142|TWO_SIDED|95.0|-2.4|16.6|||Cochran-Mantel-Haenszel|||||16.6|-2.4|0.142
72611582|NCT03104413|144751823|SUPERIORITY||Adjusted Risk Difference|9.4||||0.001|TWO_SIDED|95.0|3.8|15.1|||Cochran-Mantel-Haenszel|||||15.1|3.8|0.001
72611583|NCT03104413|144751823|SUPERIORITY||Adjusted Risk Difference|11.2|||<|0.001|TWO_SIDED|95.0|5.3|17.0|||Cochran-Mantel-Haenszel|||||17.0|5.3|<0.001
72611584|NCT03104413|144751824|SUPERIORITY||Adjusted Risk Difference|22.8|||<|0.001|TWO_SIDED|95.0|13.0|32.5|||Cochran-Mantel-Haenszel|||||32.5|13.0|<0.001
72611585|NCT03104413|144751824|SUPERIORITY||Adjusted Risk Difference|20.0|||<|0.001|TWO_SIDED|95.0|10.2|29.9|||Cochran-Mantel-Haenszel|||||29.9|10.2|<0.001
72611586|NCT03104413|144751825|SUPERIORITY||Adjusted Risk Difference|5.6||||0.377|TWO_SIDED|95.0|-6.8|17.9|||Cochran-Mantel-Haenszel|||||17.9|-6.8|0.377
72611587|NCT03104413|144751825|SUPERIORITY||Adjusted Risk Difference|13.4||||0.039|TWO_SIDED|95.0|0.7|26.1|||Cochran-Mantel-Haenszel|||||26.1|0.7|0.039
72611588|NCT03104413|144751826|SUPERIORITY||Risk Difference (RD)|-8.1||||0.002|TWO_SIDED|95.0|-13.2|-2.9|||Chi-squared|||||-2.9|-13.2|0.002
72611589|NCT03104413|144751826|SUPERIORITY||Risk Difference (RD)|-9.1|||<|0.001|TWO_SIDED|95.0|-14.1|-4.2|||Chi-squared|||||-4.2|-14.1|<0.001
72611590|NCT03104413|144751827|SUPERIORITY||Risk Difference (RD)|-6.2||||1|TWO_SIDED|95.0|-28.1|15.7|||Chi-squared|||||15.7|-28.1|1
72611591|NCT03104413|144751827|SUPERIORITY||Risk Difference (RD)|30.4||||0.113|TWO_SIDED|95.0|0.6|60.2|||Chi-squared|||||60.2|0.6|0.113
72611592|NCT03104413|144751828|SUPERIORITY||Adjusted Risk Difference|22.1|||<|0.001|TWO_SIDED|95.0|13.1|31.0|||Cochran-Mantel-Haenszel|||||31.0|13.1|<0.001
72611593|NCT03104413|144751828|SUPERIORITY||Adjusted Risk Difference|20.5|||<|0.001|TWO_SIDED|95.0|11.6|29.5|||Cochran-Mantel-Haenszel|||||29.5|11.6|<0.001
72611594|NCT03104413|144751829|SUPERIORITY||Adjusted Risk Difference|15.7||||0.001|TWO_SIDED|95.0|6.8|24.6|||Cochran-Mantel-Haenszel|||||24.6|6.8|0.001
72611595|NCT03104413|144751829|SUPERIORITY||Adjusted Risk Difference|11.8||||0.008|TWO_SIDED|95.0|3.0|20.5|||Cochran-Mantel-Haenszel|||||20.5|3|0.008
72611596|NCT03104413|144751830|SUPERIORITY||Adjusted Risk Difference|9.2||||0.006|TWO_SIDED|95.0|2.6|15.7|||Cochran-Mantel-Haenszel|||||15.7|2.6|0.006
72611597|NCT03104413|144751830|SUPERIORITY||Adjusted Risk Difference|10.3||||0.002|TWO_SIDED|95.0|3.7|16.8|||Cochran-Mantel-Haenszel|||||16.8|3.7|0.002
72611598|NCT03104413|144751831|SUPERIORITY||Adjusted Risk Difference|29.4|||<|0.001|TWO_SIDED|95.0|19.9|39.0|||Cochran-Mantel-Haenszel|||||39.0|19.9|<0.001
72611599|NCT03104413|144751831|SUPERIORITY||Adjusted Risk Difference|30.6|||<|0.001|TWO_SIDED|95.0|21.1|40.1|||Cochran-Mantel-Haenszel|||||40.1|21.1|<0.001
72611600|NCT03104413|144751832|SUPERIORITY||LS Mean Difference|2.8||||0.02|TWO_SIDED|95.0|0.4|5.1|||Mixed-Effect Model Repeat Measurement|||||5.1|0.4|0.020
72611601|NCT03104413|144751832|SUPERIORITY||LS Mean Difference|3.0||||0.01|TWO_SIDED|95.0|0.7|5.3|||Mixed-Effect Model Repeat Measurement|||||5.3|0.7|0.010
72611602|NCT03104413|144751833|SUPERIORITY||LS Mean Difference|12.4||||0.001|TWO_SIDED|95.0|5.0|19.8|||Mixed-Effect Model Repeat Measurement|||||19.8|5.0|0.001
72611603|NCT03104413|144751833|SUPERIORITY||LS Mean Difference|15.0|||<|0.001|TWO_SIDED|95.0|7.7|22.4|||Mixed-Effect Model Repeat Measurement|||||22.4|7.7|<0.001
72611604|NCT03104413|144751834|SUPERIORITY||Adjusted Risk Difference|13.9|||<|0.001|TWO_SIDED|95.0|7.1|20.7|||Cochran-Mantel-Haenszel|||||20.7|7.1|<0.001
72611605|NCT03104413|144751834|SUPERIORITY||Adjusted Risk Difference|17.3|||<|0.001|TWO_SIDED|95.0|10.3|24.2|||Cochran-Mantel-Haenszel|||||24.2|10.3|<0.001
72611606|NCT03104413|144751835|SUPERIORITY||Adjusted Risk Difference|15.0|||<|0.001|TWO_SIDED|95.0|8.9|21.2|||Cochran-Mantel-Haenszel|||||21.2|8.9|<0.001
72611607|NCT03104413|144751835|SUPERIORITY||Adjusted Risk Difference|16.2|||<|0.001|TWO_SIDED|95.0|9.9|22.4|||Cochran-Mantel-Haenszel|||||22.4|9.9|<0.001
72611608|NCT03104413|144751836|SUPERIORITY||Adjusted Risk Difference|13.6||||0.006|TWO_SIDED|95.0|4.0|23.3|||Cochran-Mantel-Haenszel|||||23.3|4|0.006
72611609|NCT03104413|144751836|SUPERIORITY||Adjusted Risk Difference|7.1||||0.142|TWO_SIDED|95.0|-2.4|16.6|||Cochran-Mantel-Haenszel|||||16.6|-2.4|0.142
72611610|NCT03104413|144751837|SUPERIORITY||Adjusted Risk Difference|9.4||||0.001|TWO_SIDED|95.0|3.8|15.1|||Cochran-Mantel-Haenszel|||||15.1|3.8|0.001
72611611|NCT03104413|144751837|SUPERIORITY||Adjusted Risk Difference|11.2|||<|0.001|TWO_SIDED|95.0|5.3|17.0|||Cochran-Mantel-Haenszel|||||17.0|5.3|<0.001
72611612|NCT03104413|144751838|SUPERIORITY||Adjusted Risk Difference|22.8|||<|0.001|TWO_SIDED|95.0|13.0|32.5|||Cochran-Mantel-Haenszel|||||32.5|13.0|<0.001
72418866|NCT02954354|144347964|SUPERIORITY|||||||0.7393||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 6||||0.7393
72418867|NCT02954354|144347964|SUPERIORITY|||||||0.0049||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 9||||0.0049
72418868|NCT02954354|144347965|SUPERIORITY|||||||0.2266||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 2||||0.2266
72418869|NCT02954354|144347965|SUPERIORITY|||||||0.1379||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 3||||0.1379
72418870|NCT02954354|144347965|SUPERIORITY|||||||0.5479||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 4||||0.5479
72418871|NCT02954354|144347965|SUPERIORITY|||||||0.0241||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 5||||0.0241
72418872|NCT02954354|144347965|SUPERIORITY|||||||0.0898||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 6||||0.0898
72418873|NCT02954354|144347965|SUPERIORITY|||||||0.2548||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 9||||0.2548
72418874|NCT02954354|144347966|SUPERIORITY||||||<|0.0001||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 2||||<0.0001
72418875|NCT02954354|144347966|SUPERIORITY||||||<|0.0001||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 3||||<0.0001
72418876|NCT02954354|144347966|SUPERIORITY|||||||0.0008||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 4||||0.0008
72611613|NCT03104413|144751838|SUPERIORITY||Adjusted Risk Difference|20.0|||<|0.001|TWO_SIDED|95.0|10.2|29.9|||Cochran-Mantel-Haenszel|||||29.9|10.2|<0.001
72611614|NCT03104413|144751839|SUPERIORITY||Adjusted Risk Difference|5.6||||0.377|TWO_SIDED|95.0|-6.8|17.9|||Cochran-Mantel-Haenszel|||||17.9|-6.8|0.377
72418877|NCT02954354|144347966|SUPERIORITY|||||||0.0132||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 5||||0.0132
72418878|NCT02954354|144347966|SUPERIORITY|||||||0.9307||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 6||||0.9307
72418879|NCT02954354|144347966|SUPERIORITY|||||||0.1677||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 9||||0.1677
72418880|NCT02954354|144347967|SUPERIORITY||||||<|0.0001||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 2||||<0.0001
72418881|NCT02954354|144347967|SUPERIORITY||||||<|0.0001||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 3||||<0.0001
72418882|NCT02954354|144347967|SUPERIORITY|||||||0.801||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 4||||0.8010
72418883|NCT02954354|144347967|SUPERIORITY|||||||0.9451||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 5||||0.9451
72611615|NCT03104413|144751839|SUPERIORITY||Adjusted Risk Difference|13.4||||0.039|TWO_SIDED|95.0|0.7|26.1|||Cochran-Mantel-Haenszel|||||26.1|0.7|0.039
72611616|NCT03104413|144751840|SUPERIORITY||LS Mean Difference|-8.1||||0.002|TWO_SIDED|95.0|-13.2|-2.9|||Mixed-Effect Model Repeat Measurement|||||-2.9|-13.2|0.002
72611617|NCT03104413|144751840|SUPERIORITY||LS Mean Difference|-9.1|||<|0.001|TWO_SIDED|95.0|-14.1|-4.2|||Mixed-Effect Model Repeat Measurement|||||-4.2|-14.1|<0.001
72418884|NCT02954354|144347967|SUPERIORITY|||||||0.2256||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 6||||0.2256
72326570|NCT00251693|144176259|SUPERIORITY_OR_OTHER|||||||0.146||95.0||||Unadjusted p-value is presented. Statistical significance was determined at 0.05 level by Hommel-Simes method within treatment and Hochberg method for comparisons of each dexlansoprazole dose to lansoprazole.|Cochran-Mantel-Haenszel|||||||0.146
72326571|NCT00251693|144176259|SUPERIORITY_OR_OTHER|||||||0.283||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Cochran-Mantel-Haenszel|||||||0.283
72326572|NCT00251693|144176260|SUPERIORITY_OR_OTHER|||||||0.896||95.0||||Unadjusted p-value is presented. Statistical significance was determined at 0.05 level by Hommel-Simes method within treatment and Hochberg method for comparisons of each dexlansoprazole dose to lansoprazole.|Log Rank|||||||0.896
72326573|NCT00251693|144176260|SUPERIORITY_OR_OTHER|||||||0.241||95.0||||Unadjusted p-value is presented. Statistical significance was determined at 0.05 level by Hommel-Simes method within treatment and Hochberg method for comparisons of each dexlansoprazole dose to lansoprazole.|Log Rank|||||||0.241
72611618|NCT03104413|144751841|SUPERIORITY||LS Mean Difference|-6.2||||1|TWO_SIDED|95.0|-28.1|15.7|||Mixed-Effect Model Repeat Measurement|||||15.7|-28.1|1.00
72326574|NCT00251693|144176260|SUPERIORITY_OR_OTHER|||||||0.211||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Log Rank|||||||0.211
72326575|NCT02030821|144176275|OTHER||||||<|0.05|||||||Kruskal-Wallis|||||||<0.05
72326576|NCT02030821|144176276|OTHER||||||<|0.05|||||||Chi-squared|||||||<0.05
72326577|NCT02030821|144176277|OTHER||||||<|0.05|||||||Kruskal-Wallis|||||||<0.05
72418885|NCT02954354|144347967|SUPERIORITY|||||||0.3332||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 9||||0.3332
72326578|NCT02030821|144176278|OTHER||||||<|0.05|||||||Kruskal-Wallis|||||||<0.05
72326579|NCT03192137|144176280|SUPERIORITY|Statistical hypotheses testing for the primary efficacy endpoint was two-sided and performed using a significance (alpha) level of 0.05.||||||0.0005||||||P-values were from a Chi-Square test (with continuity correction) of differences between treatments in the proportion of participants with anterior chamber cells Grade 0 who did not receive rescue medication versus all other grades combined.|Chi-squared, Corrected|A Fisher's exact test was used if 1 or more of the cells had an expected frequency of ≤ 5.||||||0.0005
72326580|NCT03192137|144176281|SUPERIORITY|Statistical hypotheses testing for the secondary efficacy endpoints were two-sided and performed using a significance (alpha) level of 0.05.|Odds Ratio (OR)|3.217|||<|0.0001|TWO_SIDED|95.0|1.823|5.675||P-values were from a Chi-Square test (with continuity correction).|Chi-squared, Corrected|A Fisher's exact test was used if 1 or more of the cells had an expected frequency of ≤ 5.||Statistical analysis of proportion of participants who achieved a pain score of 0 on the VAS on Day 1||5.675|1.823|<0.0001
72326581|NCT03192137|144176281|SUPERIORITY|Statistical hypotheses testing for the secondary efficacy endpoints were two-sided and performed using a significance (alpha) level of 0.05.|Odds Ratio (OR)|4.337|||<|0.0001|TWO_SIDED|95.0|2.305|8.161||P-values were from a Chi-Square test (with continuity correction).|Chi-squared, Corrected|A Fisher's exact test was used if 1 or more of the cells had an expected frequency of ≤ 5.||Statistical analysis of proportion of participants who achieved a pain score of 0 on the VAS on Day 8||8.161|2.305|<0.0001
72326582|NCT03192137|144176281|SUPERIORITY|Statistical hypotheses testing for the secondary efficacy endpoints were two-sided and performed using a significance (alpha) level of 0.05.|Odds Ratio (OR)|4.12|||<|0.0001|TWO_SIDED|95.0|2.113|8.033||P-values were from a Chi-Square test (with continuity correction).|Chi-squared, Corrected|A Fisher's exact test was used if 1 or more of the cells had an expected frequency of ≤ 5.||Statistical analysis of proportion of participants who achieved a pain score of 0 on the VAS on Day 15||8.033|2.113|<0.0001
72418886|NCT02954354|144347968|SUPERIORITY||||||<|0.0001||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 2||||<0.0001
72418887|NCT02954354|144347968|SUPERIORITY||||||<|0.0001||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 3||||<0.0001
72611619|NCT03104413|144751841|SUPERIORITY||LS Mean Difference|30.4||||0.113|TWO_SIDED|95.0|0.6|60.2|||Mixed-Effect Model Repeat Measurement|||||60.2|0.6|0.113
72611620|NCT03104413|144751842|SUPERIORITY||LS Mean Difference|-7.323||||0.113|TWO_SIDED|95.0|-16.399|1.753|||Mixed-Effect Model Repeat Measurement|||||1.753|-16.399|0.113
72611621|NCT03104413|144751842|SUPERIORITY||LS Mean Difference|-8.759||||0.05|TWO_SIDED|95.0|-17.518|-0.001|||Mixed-Effect Model Repeat Measurement|||||-0.001|-17.518|0.050
72611622|NCT03104413|144751843|SUPERIORITY||LS Mean Difference|2.221||||0.008|TWO_SIDED|95.0|0.577|3.865|||Mixed-Effect Model Repeat Measurement|||||3.865|0.577|0.008
72611623|NCT03104413|144751843|SUPERIORITY||LS Mean Difference|2.714||||0.001|TWO_SIDED|95.0|1.077|4.351|||Mixed-Effect Model Repeat Measurement|||||4.351|1.077|0.001
72611624|NCT03104413|144751844|SUPERIORITY||Adjusted Risk Difference|15.2||||0.001|TWO_SIDED|95.0|6.4|24.0|||Cochran-Mantel-Haenszel|||||24|6.4|0.001
72611625|NCT03104413|144751844|SUPERIORITY||Adjusted Risk Difference|20.4|||<|0.001|TWO_SIDED|95.0|11.5|29.3|||Cochran-Mantel-Haenszel|||||29.3|11.5|<0.001
72611626|NCT00984867|144751845|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.48|STANDARD_ERROR_OF_MEAN|0.072|<|0.0001|TWO_SIDED|95.0|-0.62|-0.34||Significant at alpha=0.05 (2-sided). A hierarchical closed testing procedure was used to control Type I error across the primary \& key secondary objectives, based on data from both strata combined|ANCOVA|with treatment group and stratum as effects and baseline value as covariate||H0: mean(treat) minus mean(placebo) = 0 versus the alternative HA: mean(treat) minus mean(placebo) =/= 0. The study consisted of two strata: sitagliptin monotherapy group and sitagliptin plus metformin group||-0.34|-0.62|<0.0001
72611627|NCT00984867|144751846|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.89|STANDARD_ERROR_OF_MEAN|0.2466|<|0.0001|TWO_SIDED|95.0|-2.37|-1.4||Significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure|ANCOVA|with treatment group and stratum as effects and baseline value as covariate||H0: mean(treat) minus mean(placebo) = 0 versus the alternative HA: mean(treat) minus mean(placebo) =/= 0. The study consisted of two strata: sitagliptin monotherapy group and sitagliptin plus metformin group||-1.40|-2.37|<0.0001
72418888|NCT02954354|144347968|SUPERIORITY||||||<|0.0001||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 4||||<0.0001
72611628|NCT00984867|144751847|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.83|STANDARD_ERROR_OF_MEAN|0.1106|<|0.0001|TWO_SIDED|95.0|-1.05|-0.62||Significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure|ANCOVA|with treatment group and stratum as effects and baseline value as covariate||H0: mean(treat) minus mean(placebo) = 0 versus the alternative HA: mean(treat) minus mean(placebo) =/= 0. The study consisted of two strata: sitagliptin monotherapy group and sitagliptin plus metformin group||-0.62|-1.05|<0.0001
72611629|NCT00984867|144751848|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-27.92|STANDARD_ERROR_OF_MEAN|3.32|<|0.0001|TWO_SIDED|95.0|-34.45|-21.4||Significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure|ANCOVA|with treatment group and stratum as effects and baseline value as covariate||H0: mean(treat) minus mean(placebo) = 0 versus the alternative HA: mean(treat) minus mean(placebo) =/= 0. The study consisted of two strata: sitagliptin monotherapy group and sitagliptin plus metformin group||-21.40|-34.45|<0.0001
72611630|NCT00984867|144751849|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.86|STANDARD_ERROR_OF_MEAN|1.4659||0.5583||95.0|-3.75|2.03||Not significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure|ANCOVA|with treatment group and stratum as effects and baseline value as covariate||H0: mean(treat) minus mean(placebo) = 0 versus the alternative HA: mean(treat) minus mean(placebo) =/= 0. The study consisted of two strata: sitagliptin monotherapy group and sitagliptin plus metformin group||2.03|-3.75|0.5583
72611631|NCT00984867|144751850|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.82|STANDARD_ERROR_OF_MEAN|3.516|||TWO_SIDED|95.0|-21.73|-7.9||Not significant. Hierarchical testing procedure stopped at previous endpoint|ANCOVA|with treatment group and stratum as effect and baseline value as covariate||H0: mean(treat) minus mean(placebo) = 0 versus the alternative HA: mean(treat) minus mean(placebo) =/= 0. The study consisted of two strata: sitagliptin monotherapy group and sitagliptin plus metformin group||-7.90|-21.73|
72611632|NCT00984867|144751851|SUPERIORITY_OR_OTHER||Risk Difference (RD)|18.7|STANDARD_ERROR_OF_MEAN|41.2|||TWO_SIDED|95.0|11.1|26.4||Not significant. Hierarchical testing procedure stopped at previous endpoint|Regression, Logistic|Based on methodology of Zhang, Tsiatis \& Davidian and Davidian, Tsiatis, Zhang \& Lu, with adjustment for baseline value and stratum||H0: proportion(treat) minus proportion(placebo) = 0 versus the alternative HA: proportion(treat) minus proportion(placebo) =/= 0.||26.4|11.1|
72611633|NCT00204737|144751857|OTHER|||||||0.06|||||||Fisher Exact|||comparison at 2 Weeks||||0.06
72418889|NCT02954354|144347968|SUPERIORITY||||||<|0.0001||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 5||||<0.0001
72418890|NCT02954354|144347968|SUPERIORITY|||||||0.001||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 6||||0.0010
72611634|NCT00204737|144751857|OTHER|||||||0.18|||||||Fisher Exact|||Comparison at 6 Weeks||||0.18
72611635|NCT00204737|144751857|OTHER|||||||0.5|||||||Fisher Exact|||Comparison at 12 weeks||||0.5
72611636|NCT01206764|144751933|OTHER|Kaplan Meier|Median Difference (Net)|27.71|||||TWO_SIDED|95.0|21.86|35.29||||||Single arm open label study||35.29|21.86|
72611637|NCT01206764|144751937|OTHER|Kaplan Meier|Median Difference (Net)|45.71|||||TWO_SIDED|95.0|31.29|106.43||||||The median overall survival was not evaluable, this presents the 25th percentile of overall survival||106.43|31.29|
72611638|NCT05824026|144751996|OTHER||||||||||||||||||"The purpose of the primary analysis was to show non-inferiority to the performance of a historical control (a silver containing gelling fiber) on proportion of wounds healed, 77%, with a non-inferiority margin of 20%. Non-inferiority was demonstrated if the lower limit of the 95% confidence interval is above 57%. An exact confidence interval for the proportion was applied. In the primary analysis missing data was not included. In the post hoc sensitivity analysis missing data was imputed using multiple imputation for 3 wounds where data was assumed to be missing at random, and otherwise imputed as wound not healed.~The supplemental analysis addressed a more conservative analysis than performed for the historical control. Hence, no formal non-inferiority criteria was applied for this analysis."|||
72611639|NCT00961415|144752002|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.5|||<|0.001|TWO_SIDED|95.0|0.37|0.69|||Log Rank|||||0.69|0.37|<0.001
72611640|NCT00961415|144752003|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.75||||0.23|TWO_SIDED|95.0|0.47|1.2|||Log Rank|||||1.20|0.47|0.230
72611641|NCT00961415|144752005|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.53||||0.006|TWO_SIDED|95.0|0.34|0.84|||Log Rank|||||0.84|0.34|0.006
72611642|NCT00961415|144752006|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.52|||<|0.001|TWO_SIDED|95.0|0.38|0.7|||Log Rank|||||0.70|0.38|<0.001
72326583|NCT03192137|144176281|SUPERIORITY|Statistical hypotheses testing for the secondary efficacy endpoints were two-sided and performed using a significance (alpha) level of 0.05.|Odds Ratio (OR)|2.58||||0.0043|TWO_SIDED|95.0|1.38|4.822||P-values were from a Chi-Square test (with continuity correction).|Chi-squared, Corrected|A Fisher's exact test was used if 1 or more of the cells had an expected frequency of ≤ 5.||Statistical analysis of proportion of participants who achieved a pain score of 0 on the VAS on Day 18||4.822|1.380|0.0043
72326584|NCT03192137|144176281|SUPERIORITY|Statistical hypotheses testing for the secondary efficacy endpoints were two-sided and performed using a significance (alpha) level of 0.05.|Odds Ratio (OR)|3.277||||0.0005|TWO_SIDED|95.0|1.695|6.335||P-values were from a Chi-Square test (with continuity correction).|Chi-squared, Corrected|A Fisher's exact test was used if 1 or more of the cells had an expected frequency of ≤ 5.||Statistical analysis of proportion of participants who achieved a pain score of 0 on the VAS on Day 29||6.335|1.695|0.0005
72326585|NCT02737501|144176323|SUPERIORITY||Hazard Ratio (HR)|0.481|||<|0.0001|TWO_SIDED|95.0|0.35|0.66||P-values are from a log-rank test stratified by randomization stratification factors (current; presence of intracranial central nervous system (iCNS) metastases at baseline and prior chemotherapy for locally advanced or metastatic disease).|Log Rank||The hazard ratio was obtained using a Cox proportional hazards model with randomization stratification factors (current) as covariates.|||0.66|0.35|<0.0001
72326586|NCT02737501|144176324|SUPERIORITY||Odds Ratio (OR)|1.74||||0.033|TWO_SIDED|95.0|1.04|2.91|||Cochran-Mantel-Haenszel||Odds ratios and p-values were from a Cochran-Mantel-Haenszel test stratified by presence of intracranial central nervous system (iCNS) metastases at Baseline, and prior chemotherapy for locally advanced or metastatic disease (current strata).|||2.91|1.04|0.0330
72326587|NCT02737501|144176325|SUPERIORITY||Odds Ratio (OR)|13.56|||<|0.0001|TWO_SIDED|95.0|4.7|39.11|||Cochran-Mantel-Haenszel||Odds ratios and p-values were from a Cochran-Mantel-Haenszel test stratified by presence of prior chemotherapy for Locally advanced or metastatic disease at study entry (current strata).|||39.11|4.70|<0.0001
72418891|NCT02954354|144347968|SUPERIORITY|||||||0.0002||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 9||||0.0002
72326588|NCT02737501|144176326|SUPERIORITY||Hazard Ratio (HR)|0.293|||<|0.0001|TWO_SIDED|95.0|0.17|0.51||P-values are from a log-rank test stratified by randomization stratification factors (current; presence of iCNS metastases at baseline and prior chemotherapy for locally advanced or metastatic disease).|Log Rank||The hazard ratio was obtained using a Cox proportional hazards model with prior chemotherapy for locally advanced or metastatic disease (current strata) as covariate.|||0.51|0.17|<0.0001
72326589|NCT02737501|144176330|SUPERIORITY||Odds Ratio (OR)|0.93||||0.822|TWO_SIDED|95.0|0.47|1.82|||Cochran-Mantel-Haenszel||Odds ratios and p-values were from a Cochran-Mantel-Haenszel test stratified by presence of iCNS metastases at Baseline, and prior chemotherapy for locally advanced or metastatic disease (current strata).|||1.82|0.47|0.8220
72326590|NCT02737501|144176332|SUPERIORITY||Least Square Mean Difference|5.79||||0.0295|TWO_SIDED|95.0|0.58|11.0||p-values were obtained using mixed effects models stratified by presence of iCNS metastases at study entry, prior chemotherapy at Baseline.|Mixed Models Analysis|A mixed effect model is used with an unstructured covariance matrix.||||11.00|0.58|0.0295
72326591|NCT00405288|144176423|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|50.0|STANDARD_DEVIATION|450.0||0.17|TWO_SIDED|95.0|0.0|200.0|||t-test, 2 sided|||"Null hypothesis: Birth weight in pregnancies exposed to Proctofoam-HC will be the same as control pregnancies.~To detect a clinically significant decrease of 200 g in birth weight at a power of 80% and alpha of 5%, 200 women per group were required. Post hoc power analysis of our cohort revealed that, in fact, we had a 91.5% power to detect a 200 g difference in birth weight between the two groups."||200|0|0.17
72418892|NCT02954354|144347969|SUPERIORITY||||||<|0.0001||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 2||||<0.0001
72326592|NCT00405288|144176424|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.0|STANDARD_DEVIATION|3.0||0.16|TWO_SIDED|95.0|0.0|3.0|||Wilcoxon (Mann-Whitney)|||||3|0|0.16
72326593|NCT00405288|144176425|SUPERIORITY_OR_OTHER||chi square|30.0||||0.003||95.0|||||McNemar|||The null hypothesis is that the proportion of vaginal deliveries in the Proctofoam and Control groups will be the same (ie. there will not be a greater proportion of complicated deliveries in either group).||||0.003
72326594|NCT00405288|144176426|SUPERIORITY_OR_OTHER||chi square|5.0||||0.55||95.0|||||McNemar|||The null hypothesis is that the proportion of pre-term births in the Proctofoam and Control groups will be the same.||||0.55
72326595|NCT00405288|144176427|SUPERIORITY_OR_OTHER||chi square|10.0||||0.97||95.0|||||McNemar|||Fetal Distress The null hypothesis is that the proportion of fetal distress in the Proctofoam and Control groups will be the same.||||0.97
72326596|NCT00405288|144176428|SUPERIORITY_OR_OTHER||binary|3.0||||0.31||95.0|||||McNemar|||Low birth weight \<2,500g; The null hypothesis is that the proportion of low birth weight babies in the Proctofoam and Control groups will be the same.||||0.31
72418893|NCT02954354|144347969|SUPERIORITY||||||<|0.0001||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 3||||<0.0001
72611658|NCT02855268|144752085|SUPERIORITY||Least square mean difference|-0.22|STANDARD_ERROR_OF_MEAN|3.27||0.9472|TWO_SIDED|95.0|-6.92|6.48||Threshold of significance was 1-sided \<0.025.|Linear mixed effect model|||Annualized rate of change in eGFR during the placebo-controlled treatment period was compared between lademirsen and placebo using a random coefficient linear mixed effect model which included time as a continuous variable.||6.48|-6.92|0.9472
72611659|NCT05033041|144752131|EQUIVALENCE|Equivalence is based on an equivalence hypothesis of -17mL \<difference in differences \< 17mL.||||||0.001|||||||t-test, 1 sided|||Comparison of the means using two one-sided t tests (TOST)||||.001
72611660|NCT05233761|144752155|SUPERIORITY|The mean nightly difference in SWS + REM sleep (% TST) in participants that received CBD-terpenes and the placebo control at the end of the two four-week treatment phases was analyzed using a two-sided test with an alpha level at 0.05 to evaluate superiority.|Mean Difference (Final Values)|1.3|STANDARD_ERROR_OF_MEAN|0.6||0.035|TWO_SIDED|95.0|0.1|2.5|||t-test, 2 sided|||The null hypothesis was that there was no difference in SWS + REM (% TST) sleep in participants that received CBD-terpenes and the placebo control; the alternative hypothesis was that there was a significant difference among the two treatment groups.||2.5|0.1|0.0350
72611661|NCT05233761|144752156|SUPERIORITY|The mean nightly difference in SWS Sleep (% TST) in participants that received CBD-terpenes and the placebo control at the end of the two four-week treatment phases was analyzed using a two-sided test with an alpha level at 0.05 to evaluate superiority. The P-value and 95% confidence interval for the estimate of treatment difference in percentages was estimated and constructed using the above-mentioned method.|Mean Difference (Final Values)|1.0|STANDARD_ERROR_OF_MEAN|0.3||0.0019|TWO_SIDED|95.0|0.4|1.6|||t-test, 2 sided|||The null hypothesis was that there was no difference in SWS Sleep (% TST) in participants that received CBD-terpenes and the placebo control; the alternative hypothesis was that there was a significant difference among the two treatment groups.||1.6|0.4|0.0019
72611662|NCT05233761|144752156|SUPERIORITY|The mean nightly difference in REM Sleep (% TST) in participants that received CBD-terpenes and the placebo control at the end of the two four-week treatment phases was analyzed using a two-sided test with an alpha level at 0.05 to evaluate superiority. The P-value and 95% confidence interval for the estimate of treatment difference in percentages was estimated and constructed using the above-mentioned method.|Mean Difference (Final Values)|0.3|STANDARD_ERROR_OF_MEAN|0.4||0.52|TWO_SIDED|95.0|-0.6|1.2|||t-test, 2 sided|||The null hypothesis was that there was no difference in REM Sleep (% TST) in participants that received CBD-terpenes and the placebo control; the alternative hypothesis was that there was a significant difference among the two treatment groups.||1.2|-.6|0.52
72611663|NCT05233761|144752156|SUPERIORITY|The mean nightly difference in Light Sleep (% TST) in participants that received CBD-terpenes and the placebo control at the end of the two four-week treatment phases was analyzed using a two-sided test with an alpha level at 0.05 to evaluate superiority. The P-value and 95% confidence interval for the estimate of treatment difference in percentages was estimated and constructed using the above-mentioned method.|Mean Difference (Final Values)|-1.7|STANDARD_ERROR_OF_MEAN|0.6||0.004|TWO_SIDED|95.0|-2.8|-0.5|||t-test, 2 sided|||The null hypothesis was that there was no difference in Light Sleep (% TST) in participants that received CBD-terpenes and the placebo control; the alternative hypothesis was that there was a significant difference among the two treatment groups.||-0.5|-2.8|0.0040
72611664|NCT05233761|144752156|SUPERIORITY|The mean nightly difference in Awake Time (% TST) in participants that received CBD-terpenes and the placebo control at the end of the two four-week treatment phases was analyzed using a two-sided test with an alpha level at 0.05 to evaluate superiority. The P-value and 95% confidence interval for the estimate of treatment difference in percentages was estimated and constructed using the above-mentioned method.|Mean Difference (Final Values)|0.7|STANDARD_ERROR_OF_MEAN|0.6||0.24|TWO_SIDED|95.0|-0.5|2.0|||t-test, 2 sided|||The null hypothesis was that there was no difference in Awake Time (% TST) sleep in participants that received CBD-terpenes and the placebo control; the alternative hypothesis was that there was a significant difference among the two treatment groups.||2.0|-.5|0.24
72611665|NCT05233761|144752157|SUPERIORITY|The mean nightly difference in SWS + REM Sleep (min) in participants that received CBD-terpenes and the placebo control at the end of the two four-week treatment phases was analyzed using a two-sided test with an alpha level at 0.05 to evaluate superiority. The P-value and 95% confidence interval for the estimate of treatment difference in percentages was estimated and constructed using the above-mentioned method.|Mean Difference (Final Values)|4.9|STANDARD_ERROR_OF_MEAN|2.6||0.0117|TWO_SIDED|95.0|1.7|13.3|||t-test, 2 sided|||The null hypothesis was that there was no difference in SWS + REM Sleep (min) in participants that received CBD-terpenes and the placebo control; the alternative hypothesis was that there was a significant difference among the two treatment groups.||13.3|1.7|0.0117
72611666|NCT05233761|144752157|SUPERIORITY|The mean nightly difference in SWS Sleep (min) in participants that received CBD-terpenes and the placebo control at the end of the two four-week treatment phases was analyzed using a two-sided test with an alpha level at 0.05 to evaluate superiority. The P-value and 95% confidence interval for the estimate of treatment difference in percentages was estimated and constructed using the above-mentioned method.|Mean Difference (Final Values)|3.3|STANDARD_ERROR_OF_MEAN|1.3||0.0126|TWO_SIDED|95.0|0.7|5.9|||t-test, 2 sided|||The null hypothesis was that there was no difference in SWS Sleep (min) in participants that received CBD-terpenes and the placebo control; the alternative hypothesis was that there was a significant difference among the two treatment groups.||5.9|0.7|0.0126
72611667|NCT05233761|144752157|SUPERIORITY|The mean nightly difference in REM sleep (min) in participants that received CBD-terpenes and the placebo control at the end of the two four-week treatment phases was analyzed using a two-sided test with an alpha level at 0.05 to evaluate superiority. The P-value and 95% confidence interval for the estimate of treatment difference in percentages was estimated and constructed using the above-mentioned method.|Mean Difference (Final Values)|1.3|STANDARD_ERROR_OF_MEAN|2.0||0.51|TWO_SIDED|95.0|-2.7|5.3|||t-test, 2 sided|||The null hypothesis was that there was no difference in REM Sleep (min) in participants that received CBD-terpenes and the placebo control; the alternative hypothesis was that there was a significant difference among the two treatment groups.||5.3|-2.7|0.51
72611668|NCT05233761|144752157|SUPERIORITY|The mean nightly difference in Light Sleep (min) in participants that received CBD-terpenes and the placebo control at the end of the two four-week treatment phases was analyzed using a two-sided test with an alpha level at 0.05 to evaluate superiority. The P-value and 95% confidence interval for the estimate of treatment difference in percentages was estimated and constructed using the above-mentioned method.|Mean Difference (Final Values)|-6.8|STANDARD_ERROR_OF_MEAN|3.6||0.0574|TWO_SIDED|95.0|-13.7|0.2|||t-test, 2 sided|||The null hypothesis was that there was no difference in Light Sleep (min) in participants that received CBD-terpenes and the placebo control; the alternative hypothesis was that there was a significant difference among the two treatment groups.||0.2|-13.7|0.0574
72611669|NCT05233761|144752157|SUPERIORITY|The mean nightly difference in Awake Time (min) in participants that received CBD-terpenes and the placebo control at the end of the two four-week treatment phases was analyzed using a two-sided test with an alpha level at 0.05 to evaluate superiority. The P-value and 95% confidence interval for the estimate of treatment difference in percentages was estimated and constructed using the above-mentioned method.|Mean Difference (Final Values)|2.2|STANDARD_ERROR_OF_MEAN|2.4||0.3|TWO_SIDED|95.0|-2.4|6.9|||t-test, 2 sided|||The null hypothesis was that there was no difference in Awake Time (min) in participants that received CBD-terpenes and the placebo control; the alternative hypothesis was that there was a significant difference among the two treatment groups.||6.9|-2.4|0.3
72611670|NCT05233761|144752157|SUPERIORITY|The mean nightly difference in Total Sleep Time (min) in participants that received CBD-terpenes and the placebo control at the end of the two four-week treatment phases was analyzed using a two-sided test with an alpha level at 0.05 to evaluate superiority. The P-value and 95% confidence interval for the estimate of treatment difference in percentages was estimated and constructed using the above-mentioned method.|Mean Difference (Final Values)|-6.9|STANDARD_ERROR_OF_MEAN|4.7||0.14|TWO_SIDED|95.0|-16.1|2.4|||t-test, 2 sided|||The null hypothesis was that there was no difference in Total Sleep Time (min) sleep in participants that received CBD-terpenes and the placebo control; the alternative hypothesis was that there was a significant difference among the two treatment groups.||2.4|-16.1|0.14
72611671|NCT05233761|144752158|SUPERIORITY|"The mean nightly difference in the perception of better sleep in participants that received CBD-terpenes and the placebo control at the end of the two four-week treatment phases was analyzed using a two-sided test with an alpha level at 0.05 to evaluate superiority. The P-value and 95% confidence interval for the estimate of treatment differences was estimated and constructed using the above-mentioned method."|Mean Difference (Final Values)|0.3|STANDARD_ERROR_OF_MEAN|0.5||0.53|TWO_SIDED|95.0|-0.7|1.3|||t-test, 2 sided|||"The null hypothesis was that there was no difference in the perception of better sleep in participants that received CBD-terpenes and the placebo control; the alternative hypothesis was that there was a significant difference among the two treatment groups."||1.3|-.7|0.53
72611672|NCT05233761|144752158|SUPERIORITY|"The mean nightly difference in the perception of sleep induction in participants that received CBD-terpenes and the placebo control at the end of the two four-week treatment phases was analyzed using a two-sided test with an alpha level at 0.05 to evaluate superiority. The P-value and 95% confidence interval for the estimate of treatment differences was estimated and constructed using the above-mentioned method."|Mean Difference (Final Values)|0.6|STANDARD_ERROR_OF_MEAN|0.6||0.32|TWO_SIDED|95.0|-0.6|1.7|||t-test, 2 sided|||"The null hypothesis was that there was no difference in the perception of sleep induction in participants that received CBD-terpenes and the placebo control; the alternative hypothesis was that there was a significant difference among the two treatment groups."||1.7|-0.6|0.32
72326597|NCT00405288|144176429|SUPERIORITY_OR_OTHER||chi square|10.0||||0.87||95.0|||||McNemar|||The null hypothesis is that the proportion of healthy babies (not requiring NICU (neonatal intensive care unit) or additional medical monitoring) will be the same between the Proctofoam and Control groups.||||0.87
72326598|NCT00405288|144176430|SUPERIORITY_OR_OTHER||proportion|4.0||||0.99||95.0|||||Fisher Exact|||||||0.99
72326599|NCT00405288|144176431|SUPERIORITY_OR_OTHER||proportion|3.0||||0.99||95.0|||||Fisher Exact|||||||0.99
72326600|NCT00405288|144176432|SUPERIORITY_OR_OTHER||proportion|2.0||||0.99||95.0|||||Fisher Exact|||||||0.99
72326601|NCT00405288|144176433|SUPERIORITY_OR_OTHER||proportions|2.0||||0.35||95.0|||||Fisher Exact|||||||0.35
72326602|NCT01646814|144176446|SUPERIORITY|||||||0.019|||||||Chi-squared|||||||0.019
72326603|NCT04570384|144176454|OTHER||Hazard Ratio (HR)|1.14||||0.782|TWO_SIDED|95.0|0.45|2.86|||Log Rank|||||2.86|0.45|0.782
72326604|NCT04570384|144176454|OTHER||Odds Ratio (OR)|1.25||||0.668|TWO_SIDED|95.0|0.46|3.4|||Regression, Logistic|||||3.40|0.46|0.668
72326605|NCT04570384|144176455|OTHER||Hazard Ratio (HR)|1.58||||0.36|TWO_SIDED|95.0|0.59|4.22|||Log Rank|||||4.22|0.59|0.360
72326606|NCT04570384|144176456|OTHER||Hazard Ratio (HR)|0.49||||0.285|TWO_SIDED|95.0|0.13|1.83|||Log Rank|||||1.83|0.13|0.285
72326607|NCT04570384|144176456|OTHER||Odds Ratio (OR)|0.6||||0.471|TWO_SIDED|95.0|0.15|2.41|||Regression, Logistic|||||2.41|0.15|0.471
72326608|NCT04570384|144176462|OTHER||Odds Ratio, log|0.81||||0.668|TWO_SIDED|95.0|0.3|2.2|||Zero-inflated negative binomial analyses|||||2.20|0.30|0.668
72326609|NCT04570384|144176462|OTHER||Incidence Rate Ratio|0.66||||0.437|TWO_SIDED|95.0|0.23|1.9|||Zero-inflated negative binomial analyses|||||1.90|0.23|0.437
72326610|NCT04570384|144176463|OTHER||Odds Ratio (OR)|0.35||||0.232|TWO_SIDED|95.0|0.06|1.97|||Regression, Logistic|||||1.97|0.06|0.232
72326611|NCT04570384|144176464|OTHER||Odds Ratio (OR)|0.84||||0.729|TWO_SIDED|95.0|0.31|2.28|||Regression, Logistic|||||2.28|0.31|0.729
72326612|NCT04570384|144176465|OTHER||Odds Ratio, log|1.22||||0.706|TWO_SIDED|95.0|0.43|3.44|||Zero-inflated negative binomial analyses|||||3.44|0.43|0.706
72326613|NCT04570384|144176465|OTHER||Incidence Rate Ratio|1.12||||0.788|TWO_SIDED|95.0|0.49|2.56|||Zero-inflated negative binomial analyses|||||2.56|0.49|0.788
72326614|NCT04570384|144176466|OTHER||Incidence Rate Ratio|1.08||||0.834|TWO_SIDED|95.0|0.52|2.25|||Negative binomial analysis|||||2.25|0.52|0.834
72326615|NCT00387088|144176519|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.102|STANDARD_ERROR_OF_MEAN|0.009|<|0.0001|TWO_SIDED|95.0|0.085|0.118|||ANCOVA|ANCOVA with pooled centre, LABA use, and treatment fitted as main effects and the baseline trough FEV1 as a covariate.||||0.118|0.085|<0.0001
72326616|NCT02848092|144176552|SUPERIORITY||Incidence Risk Ratio|0.64|||<|0.0001|TWO_SIDED|95.0|0.52|0.76|||Generalized Estimating Equation|P value is for the interaction between group (intervention vs. control) and time point (baseline vs. 1 month) using a generalized estimating equation.||||.76|.52|<.0001
72326617|NCT02848092|144176553|SUPERIORITY||Mean Difference (Final Values)|-0.21|||<|0.0001|TWO_SIDED|95.0|-0.29|-0.13|||Generalized Estimating Equation|P value is for the interaction between group (intervention vs. control) and time point (baseline vs. 1 month) using a generalized estimating equation.||||-.13|-.29|<.0001
72326618|NCT02848092|144176554|SUPERIORITY||Incidence Risk Ratio|0.64|||<|0.0001|TWO_SIDED|95.0|0.52|0.76|||Generalized Estimating Equation|P value is for the interaction between group (intervention vs. control) and time point (baseline vs. 6 month) using a generalized estimating equation.||||.76|.52|<.0001
72326619|NCT02848092|144176555|SUPERIORITY||Mean Difference (Final Values)|-0.22|||<|0.0001|TWO_SIDED|95.0|-0.31|-0.13|||Generalized Estimating Equation|P value is for the interaction between group (intervention vs. control) and time point (baseline vs. 6 month) using a generalized estimating equation.||||-.13|-.31|<.0001
72326620|NCT02848092|144176556|SUPERIORITY||Risk Ratio (RR)|0.6|||||TWO_SIDED|95.0|0.41|0.89||||||||.89|.41|
72326621|NCT02848092|144176557|SUPERIORITY||Risk Ratio (RR)|0.76|||||TWO_SIDED|95.0|0.61|0.92||||||||.92|.61|
72326622|NCT01639469|144176559|SUPERIORITY||Incidence Rate Ratio|0.39|||<|0.001|TWO_SIDED|95.0|0.22|0.68|||Negative Binomial Regression|||Testing to see if there is a significant difference in fall rates over 12months between the two groups.||0.68|0.22|<0.001
72326623|NCT00512278|144176568|NON_INFERIORITY_OR_EQUIVALENCE|Assuming a 25% difference in the rate of SVR between the PEG INF/RBV plus infliximab group (70%) and the PEG INF/RBV (45%) group, a power of 0.85 and an alpha level of 0.05, 75 patients for each group was estimated||||||0.718|||||||t-test, 2 sided|||||||0.718
72326624|NCT00512278|144176570|NON_INFERIORITY_OR_EQUIVALENCE|Assuming a 25% difference in the rate of SVR between the PEG INF/RBV plus infliximab group (70%) and the PEG INF/RBV (45%) group, a power of 0.85 and an alpha level of 0.05, 75 patients for each group was estimated.||||||0.718|TWO_SIDED|95.0||||Univariate and multivariable logistic regression were used for factors associated with an SVR.|t-test, 2 sided|||SVR was the primary outcome to calculate sample size. Assuming a 25% difference in the rate of SVR between the the two groups, a power of 0.85 and an alpha level of 0.05, 75 patients for each group was estimated. This analysis included patients randomized and received at least one dose of study drugs. A 2-sided probability value of \< 0.05 was considered statistically significant. Univariate and multivariable logistic regression were used for factors associated with an SVR.||||0.718
72326625|NCT01106157|144176591|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.277|STANDARD_ERROR_OF_MEAN|0.134||0.017|TWO_SIDED|95.0|0.001|0.552|||t-test, 2 sided|||||0.552|0.001|0.017
72326626|NCT01106157|144176592|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.08|STANDARD_ERROR_OF_MEAN|0.104||0.43|TWO_SIDED|95.0|-0.3|0.13|||t-test, 2 sided|||||0.13|-0.30|0.43
72326627|NCT01106157|144176593|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.51|STANDARD_ERROR_OF_MEAN|0.7||0.37|TWO_SIDED|95.0|-1.64|0.63|||t-test, 2 sided|||||0.63|-1.64|0.37
72326628|NCT01106157|144176594|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.064|STANDARD_ERROR_OF_MEAN|0.16||0.69|TWO_SIDED|95.0|-0.4|0.27|||t-test, 2 sided|||||0.27|-0.40|0.69
72326629|NCT01106157|144176595|SUPERIORITY_OR_OTHER||Mean Difference (Net)|11.75|STANDARD_ERROR_OF_MEAN|81.3||0.89|TWO_SIDED|95.0|-156.8|180.3|||t-test, 2 sided|||||180.3|-156.8|0.89
72326630|NCT01106157|144176596|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.28|STANDARD_ERROR_OF_MEAN|0.21||0.2|TWO_SIDED|95.0|-0.15|0.7|||t-test, 2 sided|||||0.70|-0.15|0.2
72326631|NCT01106157|144176597|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-24.13|STANDARD_ERROR_OF_MEAN|19.61||0.23|TWO_SIDED|95.0|-64.8|16.7|||t-test, 2 sided|||||16.7|-64.8|0.23
72326632|NCT01106157|144176598|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.037|STANDARD_ERROR_OF_MEAN|0.1||0.79|TWO_SIDED|95.0|-0.18|0.23|||t-test, 2 sided|||||0.23|-0.18|0.79
72326633|NCT01106157|144176599|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-7.67|STANDARD_ERROR_OF_MEAN|5.33||0.163|TWO_SIDED|95.0|-18.7|3.35|||t-test, 2 sided|||||3.35|-18.7|0.163
72326634|NCT01118780|144176633|SUPERIORITY_OR_OTHER||LS mean difference|4.17|STANDARD_ERROR_OF_MEAN|0.86|<|0.001|TWO_SIDED|95.0|2.47|5.88|||Mixed Models Analysis||LS mean difference was calculated by placebo minus duloxetine. Positive values indicated improvement over placebo.|||5.88|2.47|<0.001
72326635|NCT01118780|144176634|SUPERIORITY_OR_OTHER||LS mean difference|3.23|STANDARD_ERROR_OF_MEAN|0.82|<|0.001|TWO_SIDED|95.0|1.61|4.85|||Mixed Models Analysis||LS mean difference was calculated by placebo minus duloxetine. Positive values indicated improvement over placebo.|||4.85|1.61|<0.001
72326636|NCT01118780|144176635|SUPERIORITY_OR_OTHER||LS mean difference|2.4|STANDARD_ERROR_OF_MEAN|0.49|<|0.001|TWO_SIDED|95.0|1.43|3.37||The p-value is for the change from baseline to Week 10 in the HAMA Psychic Anxiety Factor Score.|Mixed Models Analysis||LS mean difference was calculated by placebo minus duloxetine. Positive values indicated improvement over placebo.|||3.37|1.43|<0.001
72418894|NCT02954354|144347969|SUPERIORITY|||||||0.4148||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 4||||0.4148
72326637|NCT01118780|144176635|SUPERIORITY_OR_OTHER||LS mean difference|1.76|STANDARD_ERROR_OF_MEAN|0.45|<|0.001|TWO_SIDED|95.0|0.87|2.65||The p-value is for the change from baseline to Week 10 in the HAMA Somatic Anxiety Factor Score.|Mixed Models Analysis||LS mean difference was calculated by placebo minus duloxetine. Positive values indicated improvement over placebo.|||2.65|0.87|<0.001
72326638|NCT01118780|144176635|SUPERIORITY_OR_OTHER||LS mean difference|0.52|STANDARD_ERROR_OF_MEAN|0.11|<|0.001|TWO_SIDED|95.0|0.3|0.74||The p-value is for the change from baseline to Week 10 in the HAMA Anxious Mood Item Score.|Mixed Models Analysis||LS mean difference was calculated by placebo minus duloxetine. Positive values indicated improvement over placebo.|||0.74|0.30|<0.001
72326639|NCT01118780|144176635|SUPERIORITY_OR_OTHER||LS mean difference|0.31|STANDARD_ERROR_OF_MEAN|0.11||0.007|TWO_SIDED|95.0|0.09|0.53||The p-value is for the change from baseline to Week 10 in the HAMA Tension Item Score.|Mixed Models Analysis||LS mean difference was calculated by placebo minus duloxetine. Positive values indicated improvement over placebo.|||0.53|0.09|0.007
72326640|NCT01118780|144176636|SUPERIORITY_OR_OTHER||LS mean difference|2.19|STANDARD_ERROR_OF_MEAN|0.5|<|0.001|TWO_SIDED|95.0|1.2|3.18||The p-value is for the change from baseline to Week 10 in the HADS Anxiety Subscale Score.|Mixed Models Analysis||LS mean difference was calculated by placebo minus duloxetine. Positive values indicated improvement over placebo.|||3.18|1.20|<0.001
72326641|NCT01118780|144176636|SUPERIORITY_OR_OTHER||LS mean difference|1.69|STANDARD_ERROR_OF_MEAN|0.41|<|0.001|TWO_SIDED|95.0|0.89|2.49||The p-value is for the change from baseline to Week 10 in the HADS Depression Subscale Score.|Mixed Models Analysis||LS mean difference was calculated by placebo minus duloxetine. Positive values indicated improvement over placebo.|||2.49|0.89|<0.001
72326642|NCT01118780|144176637|SUPERIORITY_OR_OTHER||LS mean difference|0.53|STANDARD_ERROR_OF_MEAN|0.14|<|0.001|TWO_SIDED|95.0|0.26|0.79|||Mixed Models Analysis||LS mean difference was calculated by placebo minus duloxetine. Positive values indicated improvement over placebo.|||0.79|0.26|<0.001
72326643|NCT01118780|144176638|SUPERIORITY_OR_OTHER||LS mean difference|0.62|STANDARD_ERROR_OF_MEAN|0.15|<|0.001|TWO_SIDED|95.0|0.33|0.91|||Mixed Models Analysis||LS mean difference was calculated by placebo minus duloxetine. Positive values indicated improvement over placebo.|||0.91|0.33|<0.001
72326644|NCT01118780|144176639|SUPERIORITY_OR_OTHER||LS mean difference|0.55|STANDARD_ERROR_OF_MEAN|0.29||0.059|TWO_SIDED|95.0|-0.02|1.11||The p-value is for the change from baseline to Week 10 in BPI-SF Worst Pain Score.|Mixed Models Analysis||LS mean difference was calculated by placebo minus duloxetine. Positive values indicated improvement over placebo.|||1.11|-0.02|0.059
72326645|NCT01118780|144176639|SUPERIORITY_OR_OTHER||LS mean difference|0.42|STANDARD_ERROR_OF_MEAN|0.24||0.079|TWO_SIDED|95.0|-0.05|0.89||The p-value is for the change from baseline to Week 10 in BPI-SF Least Pain Score.|Mixed Models Analysis||LS mean difference was calculated by placebo minus duloxetine. Positive values indicated improvement over placebo.|||0.89|-0.05|0.079
72326646|NCT01118780|144176639|SUPERIORITY_OR_OTHER||LS mean difference|0.42|STANDARD_ERROR_OF_MEAN|0.25||0.089|TWO_SIDED|95.0|-0.06|0.91||The p-value is for the change from baseline to Week 10 in BPI-SF Average Pain Score.|Mixed Models Analysis||LS mean difference was calculated by placebo minus duloxetine. Positive values indicated improvement over placebo.|||0.91|-0.06|0.089
72326647|NCT01118780|144176639|SUPERIORITY_OR_OTHER||LS mean difference|0.23|STANDARD_ERROR_OF_MEAN|0.25||0.371|TWO_SIDED|95.0|-0.27|0.73||The p-value is for the change from baseline to Week 10 in BPI-SF Pain Right Now Score.|Mixed Models Analysis||LS mean difference was calculated by placebo minus duloxetine. Positive values indicated improvement over placebo.|||0.73|-0.27|0.371
72326648|NCT01118780|144176639|SUPERIORITY_OR_OTHER||LS mean difference|0.53|STANDARD_ERROR_OF_MEAN|0.29||0.066|TWO_SIDED|95.0|-0.04|1.09||The p-value is for the change from baseline to Week 10 in BPI-SF General Activity Score.|Mixed Models Analysis||LS mean difference was calculated by placebo minus duloxetine. Positive values indicated improvement over placebo.|||1.09|-0.04|0.066
72326649|NCT01118780|144176639|SUPERIORITY_OR_OTHER||LS mean difference|0.41|STANDARD_ERROR_OF_MEAN|0.27||0.14|TWO_SIDED|95.0|-0.13|0.95||The p-value is for the change from baseline to Week 10 in BPI-SF Mood Score.|Mixed Models Analysis||LS mean difference was calculated by placebo minus duloxetine. Positive values indicated improvement over placebo.|||0.95|-0.13|0.140
72611673|NCT05233761|144752158|SUPERIORITY|"The mean nightly difference in the perception of sleep duration in participants that received CBD-terpenes and the placebo control at the end of the two four-week treatment phases was analyzed using a two-sided test with an alpha level at 0.05 to evaluate superiority. The P-value and 95% confidence interval for the estimate of treatment differences was estimated and constructed using the above-mentioned method."|Mean Difference (Final Values)|0.7|STANDARD_ERROR_OF_MEAN|0.6||0.2|TWO_SIDED|95.0|-0.4|1.9|||t-test, 2 sided|||"The null hypothesis was that there was no difference in the perception of sleep duration in participants that received CBD-terpenes and the placebo control; the alternative hypothesis was that there was a significant difference among the two treatment groups."||1.9|-0.4|0.20
72611674|NCT05233761|144752158|SUPERIORITY|"The mean nightly difference in the perception of sleep depth in participants that received CBD-terpenes and the placebo control at the end of the two four-week treatment phases was analyzed using a two-sided test with an alpha level at 0.05 to evaluate superiority. The P-value and 95% confidence interval for the estimate of treatment differences was estimated and constructed using the above-mentioned method."|Mean Difference (Final Values)|0.5|STANDARD_ERROR_OF_MEAN|0.6||0.45|TWO_SIDED|95.0|-0.7|1.6|||t-test, 2 sided|||"The null hypothesis was that there was no difference in the perception of sleep depth in participants that received CBD-terpenes and the placebo control; the alternative hypothesis was that there was a significant difference among the two treatment groups."||1.6|-0.7|0.45
72611675|NCT05233761|144752158|SUPERIORITY|"The mean nightly difference in the perception of vivid dreams in participants that received CBD-terpenes and the placebo control at the end of the two four-week treatment phases was analyzed using a two-sided test with an alpha level at 0.05 to evaluate superiority. The P-value and 95% confidence interval for the estimate of treatment differences was estimated and constructed using the above-mentioned method."|Mean Difference (Final Values)|0.6|STANDARD_ERROR_OF_MEAN|0.7||0.4|TWO_SIDED|95.0|-0.8|1.9|||t-test, 2 sided|||"The null hypothesis was that there was no difference in the perception of vivid dreams in participants that received CBD-terpenes and the placebo control; the alternative hypothesis was that there was a significant difference among the two treatment groups."||1.9|-0.8|0.4
72611676|NCT03729362|144752241|SUPERIORITY|Analysis used a mixed-effect model for repeated measures (MMRM). The model included terms for treatment, baseline 6MWD, age, height, weight (all as continuous covariates), enzyme replacement therapy (ERT) status (ERT-naïve versus ERT-experienced), gender, time, and treatment-by-time interaction. Time was used as a repeated measure, and an unstructured covariance approach was applied.|LS Mean Difference|14.21|STANDARD_ERROR_OF_MEAN|8.481||0.048|TWO_SIDED|95.0|-2.6|31.02||1-sided significance level of 0.025.|MMRM|||"The primary and key secondary endpoints were tested in hierarchical order as follows:~The test for the primary endpoint was conducted first at the 1-sided 0.025 significance level, and if significant, the ordered key secondary endpoints were similarly tested. If at any point the null hypothesis for superiority failed to be rejected, then that comparison and any other comparison below it could not be claimed as successful and would be considered nominal."||31.02|-2.6|0.048
72611677|NCT03729362|144752242|SUPERIORITY|The analysis used an Analysis of Covariance (ANCOVA) model adjusted for the baseline value (as a continuous covariate) and ERT status (ERT-naïve versus ERT-experienced), as well as baseline age, gender, baseline height, and baseline weight.|LS Mean Difference|2.66|STANDARD_ERROR_OF_MEAN|1.156||0.012|TWO_SIDED|95.0|0.37|4.95||1-sided significance level of 0.025.|ANCOVA|||Change from baseline to Week 52 in sitting FVC was the first of 6 key secondary efficacy endpoints, which were analyzed according to a hierarchical order.||4.95|0.37|0.012
72611678|NCT03729362|144752243|SUPERIORITY|The analysis used an ANCOVA model adjusted for the baseline value (as a continuous covariate) and ERT status (ERT-naïve versus ERT-experienced), as well as baseline age, gender, baseline height, and baseline weight.|LS Mean Difference|0.96|STANDARD_ERROR_OF_MEAN|0.727||0.095|TWO_SIDED|95.0|-0.48|2.4||1-sided significance level of 0.025.|ANCOVA|||Change from baseline to Week 52 in the MMT score for the lower extremities was the second of 6 key secondary efficacy endpoints, which were analyzed according to a hierarchical order.||2.4|-0.48|0.095
72611679|NCT03729362|144752244|SUPERIORITY|The analysis used an ANCOVA model adjusted for the baseline value (as a continuous covariate) and ERT status (ERT-naïve versus ERT-experienced), as well as baseline age, gender, baseline height, and baseline weight.|LS Mean Difference|8.17|STANDARD_ERROR_OF_MEAN|6.261||0.097|TWO_SIDED|95.0|-4.24|20.57||1-sided significance level of 0.025.|ANCOVA|||Change from baseline to Week 26 in 6MWD was the third of 6 key secondary efficacy endpoints, which were analyzed according to a hierarchical order.||20.57|-4.24|0.097
72611680|NCT03729362|144752245|SUPERIORITY|The analysis used an ANCOVA model adjusted for the baseline value (as a continuous covariate) and ERT status (ERT-naïve versus ERT-experienced), as well as baseline age, gender, baseline height, and baseline weight.|LS Mean Difference|1.87|STANDARD_ERROR_OF_MEAN|1.706||0.138|TWO_SIDED|95.0|-1.51|5.25||1-sided significance level of 0.025|ANCOVA|||Change from baseline to Week 52 in the total score for the PROMIS® - Physical Function was the fourth of 6 key secondary efficacy endpoints, which were analyzed according to a hierarchical order.||5.25|-1.51|0.138
72611681|NCT03729362|144752246|SUPERIORITY|The analysis used an ANCOVA model adjusted for the baseline value (as a continuous covariate) and ERT status (ERT-naïve versus ERT-experienced), as well as baseline age, gender, baseline height, and baseline weight.|LS Mean Difference|0.04|STANDARD_ERROR_OF_MEAN|1.092||0.515|TWO_SIDED|95.0|-2.12|2.2||1-sided significance level of 0.025|ANCOVA|||Change from baseline to Week 52 in the total score for the PROMIS® - Fatigue was the fifth of 6 key secondary efficacy endpoints, which were analyzed according to a hierarchical order.||2.2|-2.12|0.515
72418895|NCT02954354|144347969|SUPERIORITY|||||||0.0338||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 5||||0.0338
72611682|NCT03729362|144752247|SUPERIORITY|The analysis used an ANCOVA model adjusted for the baseline value (as a continuous covariate) and ERT status (ERT-naïve versus ERT-experienced), as well as baseline age, gender, baseline height, and baseline weight.|LS Mean Difference|-1.414|STANDARD_ERROR_OF_MEAN|0.528||0.004|TWO_SIDED|95.0|-2.463|-0.364||1-sided significance level of 0.025.|ANCOVA|||Change from baseline to Week 52 in the total score for the GSGC was the sixth of 6 key secondary efficacy endpoints, which were analyzed according to a hierarchical order.||-0.364|-2.463|0.004
72611683|NCT00362232|144752277|NON_INFERIORITY_OR_EQUIVALENCE|P-values were calculated based on the Mantel-Haenszel weighted estimator (one-sided).|Risk Difference (RD)|-2.71|||<|0.001||95.0|-5.25|-0.17|||Mantel Haenszel|weighted treatment differences|Mantel-Haenszel weighted difference to Enoxaparin|Null hypothesis: rivaroxaban is inferior to the comparator, ie, the incidence of the primary efficacy endpoint in the rivaroxaban group is larger by more than 4% (absolute) compared to the comparator group.||-0.17|-5.25|<0.001
72611684|NCT00362232|144752277|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-2.71||||0.036||95.0|-5.25|-0.17|||Mantel Haenszel|weighted treatment differences||Null hypothesis: The incidence of the primary efficacy endpoint is equal in the rivaroxaban group and the comparator group. P-values were calculated based on the Mantel-Haenszel weighted estimator (two-sided).||-0.17|-5.25|0.036
72611685|NCT00362232|144752278|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-3.19||||0.012||95.0|-5.67|-0.71|||Mantel Haenszel|weighted treatment differences|Mantel-Haenszel weighted difference to Enoxaparin|Null hypothesis: The incidence of the primary efficacy endpoint is equal in the rivaroxaban group and the comparator group. P-values were calculated based on the Mantel-Haenszel weighted estimator (two-sided).||-0.71|-5.67|0.012
72611686|NCT00362232|144752279|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.37||||0.456||95.0|-1.34|0.6|||Mantel Haenszel|weighted treatment differences|Mantel-Haenszel weighted difference to Enoxaparin|Null hypothesis: The incidence of the major VTE is equal in the rivaroxaban group and the comparator group. P-values were calculated based on the Mantel-Haenszel weighted estimator (two-sided)||0.6|-1.34|0.456
72611687|NCT00362232|144752279|NON_INFERIORITY_OR_EQUIVALENCE|P-values were calculated based on the Mantel-Haenszel weighted estimator (one-sided).|Risk Difference (RD)|-0.37|||<|0.001||95.0|-1.34|0.6|||Mantel Haenszel|weighted treatment differences||Null hypothesis: rivaroxaban is inferior to the comparator, ie, the incidence of the major VTE in the rivaroxaban group is larger by more than 1.5% (absolute) compared to the comparator group.||0.6|-1.34|<0.001
72611688|NCT00362232|144752280|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.8||||0.124||95.0|-1.82|0.22|||Mantel Haenszel|weighted treatment differences|Mantel-Haenszel weighted difference to Enoxaparin|Null hypothesis: The incidence of the major VTE is equal in the rivaroxaban group and the comparator group. P-values were calculated based on the Mantel-Haenszel weighted estimator (two-sided)||0.22|-1.82|0.124
72611689|NCT00362232|144752280|NON_INFERIORITY_OR_EQUIVALENCE|P-values were calculated based on the Mantel-Haenszel weighted estimator (one-sided).|Risk Difference (RD)|-0.8|||<|0.001||95.0|-1.82|0.22|||Mantel Haenszel|weighted treatment differences||Null hypothesis: rivaroxaban is inferior to the comparator, ie, the incidence of the major VTE in the rivaroxaban group is larger by more than 1.5% (absolute) compared to the comparator group.||0.22|-1.82|<0.001
72611690|NCT00362232|144752281|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.44||||||95.0|-1.59|0.66|||||Mantel-Haenszel weighted difference to Enoxaparin|||0.66|-1.59|
72611691|NCT00362232|144752282|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.72||||||95.0|-1.81|0.36|||||Mantel-Haenszel weighted difference to Enoxaparin|||0.36|-1.81|
72611692|NCT00362232|144752283|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-2.38||||||95.0|-4.84|0.07|||||Mantel-Haenszel weighted difference to Enoxaparin|||0.07|-4.84|
72611693|NCT00362232|144752284|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-2.67||||||95.0|-5.02|-0.32|||||Mantel-Haenszel weighted difference to Enoxaparin|||-0.32|-5.02|
72611694|NCT00362232|144752285|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.24||||||95.0|-0.22|0.71|||||Mantel-Haenszel weighted difference to Enoxaparin|||0.71|-0.22|
72611695|NCT00362232|144752286|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.11||||||95.0|-0.35|0.56||||||||0.56|-0.35|
72611696|NCT00362232|144752287|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.3||||||95.0|-1.56|0.94|||||Exact methods for difference to Enoxaparin|||0.94|-1.56|
72611697|NCT00362232|144752288|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-2.47||||0.054||95.0|-4.99|0.04|||Mantel Haenszel|weighted treatment differences|Mantel-Haenszel weighted difference to Enoxaparin|Null hypothesis: The incidence rate is equal in the rivaroxaban group and the comparator group. P-values were calculated based on the Mantel-Haenszel weighted estimator (two-sided)||0.04|-4.99|0.054
72418896|NCT02954354|144347969|SUPERIORITY|||||||0.9619||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 6||||0.9619
72418897|NCT02954354|144347969|SUPERIORITY|||||||0.8491||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 9||||0.8491
72418898|NCT02954354|144347970|SUPERIORITY||||||<|0.0001||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||||||<0.0001
72611698|NCT00362232|144752288|NON_INFERIORITY_OR_EQUIVALENCE|P-values were calculated based on the Mantel-Haenszel weighted estimator (one-sided).|Risk Difference (RD)|-2.47|||<|0.001||95.0|-4.49|0.04|||Mantel Haenszel|weighted treatment differences||Null hypothesis: rivaroxaban is inferior to the comparator, ie, the incidence rate in the rivaroxaban group is larger by more than 4% (absolute) compared to the comparator group.||0.04|-4.49|<0.001
72611699|NCT00362232|144752289|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-2.97||||0.017||95.0|-5.42|-0.53|||Mantel Haenszel|weighted treatment differences|Mantel-Haenszel weighted difference to Enoxaparin|Null hypothesis: The incidence rate is equal in the rivaroxaban group and the comparator group. P-values were calculated based on the Mantel-Haenszel weighted estimator (two-sided)||-0.53|-5.42|0.017
72611700|NCT00362232|144752289|NON_INFERIORITY_OR_EQUIVALENCE|P-values were calculated based on the Mantel-Haenszel weighted estimator (one-sided).|Risk Difference (RD)|-2.97|||<|0.001||95.0|-5.42|-0.53|||Mantel Haenszel|weighted treatment differences||Null hypothesis: rivaroxaban is inferior to the comparator, ie, the incidence rate in the rivaroxaban group is larger by more than 4% (absolute) compared to the comparator group.||-0.53|-5.42|<0.001
72611701|NCT00362232|144752290|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.57||||0.27||95.0|-1.57|0.44|||Mantel Haenszel|weighted treatment differences|Mantel-Haenszel weighted difference to Enoxaparin|Null hypothesis: The incidence rate is equal in the rivaroxaban group and the comparator group. P-values were calculated based on the Mantel-Haenszel weighted estimator (two-sided)||0.44|-1.57|0.270
72611702|NCT00362232|144752290|NON_INFERIORITY_OR_EQUIVALENCE|P-values were calculated based on the Mantel-Haenszel weighted estimator (one-sided).|Risk Difference (RD)|-0.57|||<|0.001||95.0|-1.57|0.44|||Mantel Haenszel|weighted treatment differences||Null hypothesis: rivaroxaban is inferior to the comparator, ie, the incidence rate in the rivaroxaban group is larger by more than 1.5% (absolute) compared to the comparator group.||0.44|-1.57|<0.001
72326650|NCT01118780|144176639|SUPERIORITY_OR_OTHER||LS mean difference|0.6|STANDARD_ERROR_OF_MEAN|0.29||0.04|TWO_SIDED|95.0|0.03|1.18||The p-value is for the change from baseline to Week 10 in BPI-SF Walking Ability Score.|Mixed Models Analysis||LS mean difference was calculated by placebo minus duloxetine. Positive values indicated improvement over placebo.|||1.18|0.03|0.040
72418899|NCT02954354|144347971|SUPERIORITY|||||||0.0313||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||||||0.0313
72418900|NCT02954354|144347972|SUPERIORITY||||||<|0.0001||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|van Elteren test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||||||<0.0001
72418901|NCT02954354|144347973|SUPERIORITY|||||||0.2424||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||||||0.2424
72418902|NCT02954354|144347974|SUPERIORITY||Difference|-72.0|||<|0.0001|TWO_SIDED|95.0|-72.0|-48.0||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Generalized Wilcoxon test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||||-48.0|-72.0|<0.0001
72418903|NCT02954354|144347975|SUPERIORITY||Difference|-48.0|||<|0.0001|TWO_SIDED|95.0|-72.0|-24.0||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Generalized Wilcoxon test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||||-24.0|-72.0|<0.0001
72418904|NCT02954354|144347976|SUPERIORITY||Difference|-24.0||||0.002|TWO_SIDED|95.0|-120.0|0.0||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Generalized Wilcoxon test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||||0.0|-120.0|0.0020
72418905|NCT02954354|144347977|SUPERIORITY||Difference|-24.0||||0.0102|TWO_SIDED|95.0|-48.0|24.0||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Generalized Wilcoxon test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||||24.0|-48.0|0.0102
72418906|NCT02954354|144347978|SUPERIORITY|||||||0.5973||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||12 hours||||0.5973
72418907|NCT02954354|144347978|SUPERIORITY|||||||0.001||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||24 hours||||0.0010
72418908|NCT02954354|144347978|SUPERIORITY||||||<|0.0001||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||36 hours||||<0.0001
72418909|NCT02954354|144347978|SUPERIORITY||||||<|0.0001||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||48 hours||||<0.0001
72418910|NCT02954354|144347978|SUPERIORITY||||||<|0.0001||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||72 hours||||<0.0001
72418911|NCT02954354|144347978|SUPERIORITY|||||||0.0115||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||96 hours||||0.0115
72418912|NCT02954354|144347978|SUPERIORITY|||||||0.1298||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||120 hours||||0.1298
72418913|NCT02954354|144347978|SUPERIORITY|||||||0.117||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||144 hours||||0.1170
72418914|NCT02954354|144347978|SUPERIORITY|||||||0.0757||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||168 hours||||0.0757
72611703|NCT00362232|144752291|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.98||||0.074||95.0|-2.06|0.1|||Mantel Haenszel|weighted treatment differences|Mantel-Haenszel weighted difference to Enoxaparin|Null hypothesis: The incidence rate is equal in the rivaroxaban group and the comparator group. P-values were calculated based on the Mantel-Haenszel weighted estimator (two-sided)||0.10|-2.06|0.074
72611704|NCT00362232|144752291|NON_INFERIORITY_OR_EQUIVALENCE|P-values were calculated based on the Mantel-Haenszel weighted estimator (one-sided) .|Risk Difference (RD)|-0.98|||<|0.001||95.0|-2.06|0.1|||Mantel Haenszel|weighted treatment differences||Null hypothesis: rivaroxaban is inferior to the comparator, ie, the incidence rate in the rivaroxaban group is larger by more than 1.5% (absolute) compared to the comparator group.||0.10|-2.06|<0.001
72611705|NCT00362232|144752292|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.39||||0.11||95.0|-0.09|0.88|||Mantel Haenszel|weighted treatment differences|Mantel-Haenszel weighted difference to Enoxaparin|Null hypothesis: The incidence rate is equal in the rivaroxaban group and the comparator group. P-values were calculated based on the Mantel-Haenszel weighted estimator (two-sided)||0.88|-0.09|0.110
72418915|NCT02954354|144347978|SUPERIORITY|||||||0.9453||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||192 hours||||0.9453
72418916|NCT02954354|144347978|SUPERIORITY|||||||0.8657||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||216 hours||||0.8657
72418917|NCT02954354|144347979|SUPERIORITY|||||||0.0458||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||12 hours||||0.0458
72611706|NCT02100631|144752301|NON_INFERIORITY|The lower limit of the two sided 95% Wald CI on the difference in seroconversion rate was estimated by inverting a Z test with pooled variance. The lower limit of the CI had be greater than -10 percentage points to prove non-inferiority. The lower bound of the CI on the older adults serconversion rate was required to exceed 70%.|Risk Difference (RD)|-3.1|||||TWO_SIDED|95.0|-6.7|0.4||||||||0.4|-6.7|
72611707|NCT02100631|144752302|OTHER||Geometric Mean Ratio (GMR)|0.44|||||TWO_SIDED|95.0|0.34|0.57||||||||0.57|0.34|
72611708|NCT02100631|144752303|NON_INFERIORITY|Analysis for information only. No non-inferiority margin specified.|Risk Difference (RD)|0.6|||||TWO_SIDED|95.0|-2.2|3.5||||||||3.5|-2.2|
72611709|NCT02100631|144752304|NON_INFERIORITY|Analysis for information only. No non-inferiority margin specified.||||||0.0062|||||||t-test, 2 sided|||||||0.0062
72418918|NCT02954354|144347979|SUPERIORITY|||||||0.7565||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||24 hours||||0.7565
72418919|NCT02954354|144347979|SUPERIORITY|||||||0.3297||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||36 hours||||0.3297
72418920|NCT02954354|144347979|SUPERIORITY|||||||0.4442||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||48 hours||||0.4442
72418921|NCT02954354|144347979|SUPERIORITY|||||||0.6029||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||72 hours||||0.6029
72418922|NCT02954354|144347979|SUPERIORITY|||||||0.9881||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||96 hours||||0.9881
72418923|NCT02954354|144347979|SUPERIORITY|||||||0.9257||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||120 hours||||0.9257
72611710|NCT02054156|144752344|SUPERIORITY||Hazard Ratio (HR)|0.56||||0.0043|TWO_SIDED|95.0|0.37|0.83|||Cox Proportional Hazards Model||The estimate is adjusted for age strata (\>=6 months - 3 years, \>3 - 6 years, \>6 - 12 years, and \>12 - 18 years).|||0.83|0.37|0.0043
72418924|NCT02954354|144347979|SUPERIORITY|||||||0.5317||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||144 hours||||0.5317
72611711|NCT02054156|144752345|SUPERIORITY||Hazard Ratio (HR)|1.0||||0.9915|TWO_SIDED|95.0|0.64|1.55|||Cox Proportional Hazards Model||The estimate is adjusted for age strata (\>=6 months - 3 years, \>3 - 6 years, \>6 - 12 years, and \>12 - 18 years).|||1.55|0.64|0.9915
72611712|NCT02054156|144752346|SUPERIORITY||Difference in % of Participants with SAE|-2.5||||0.7531|TWO_SIDED|95.0|-13.7|8.7|||Fisher Exact||95% confidence interval calculated using the Newcombe-Wilson method without continuity correction.|||8.7|-13.7|0.7531
72611713|NCT02054156|144752346|SUPERIORITY||Difference in % of Participants with AE|4.4||||0.3593|TWO_SIDED|95.0|-3.5|12.6|||Fisher Exact||95% confidence interval calculated using the Newcombe-Wilson.|||12.6|-3.5|0.3593
72611714|NCT02054156|144752347|SUPERIORITY||Rate Ratio|0.86||||0.0004|TWO_SIDED|95.0|0.8|0.94|||Poisson Regression|||Rate Ratio for Adverse Events calculated using Poisson Regression with an offset for the log of follow-up time in months. The total number of follow-up months of all participants (not per participant) in the trial was as follows: in the Azithromycin group was 1267.73 and in the Placebo group was 1193.72.||0.94|0.80|0.0004
72611715|NCT02054156|144752347|SUPERIORITY||Rate Ratio|1.25||||0.2098|TWO_SIDED|95.0|0.88|1.78|||Poisson Regression|||Rate Ratio for Serious Adverse Events calculated using Poisson Regression with an offset for the log of follow-up time in months. The total number of follow-up months of all participants (not per participant) in the trial was as follows: in the Azithromycin group was 1267.73 and in the Placebo group was 1193.72.||1.78|0.88|0.2098
72611716|NCT01928849|144752348|OTHER||Odds Ratio (OR)|0.77||||0.53|TWO_SIDED|95.0|0.34|1.74|||Regression, Logistic|Univariable Logistic regression||||1.74|0.34|0.53
72611717|NCT01928849|144752349|OTHER|||||||0.95|||||||Chi-squared|||Comparison of rate of residual limb pain between treatment groups||||0.95
72611718|NCT01928849|144752349|OTHER|||||||0.74|||||||Chi-squared|||Comparison of rate of Phantom limb pain between treatment groups||||0.74
72611719|NCT01928849|144752350|OTHER|||||||0.27|||||||Wilcoxon (Mann-Whitney)|||Comparison of opioid consumption postoperative hours 0-24||||0.27
72611720|NCT01928849|144752350|OTHER|||||||0.27|||||||Wilcoxon (Mann-Whitney)|||Comparison of opioid consumption postoperative hours 24-48||||0.27
72611721|NCT01928849|144752351|OTHER|||||||0.59|||||||Wilcoxon (Mann-Whitney)|||Comparison of BPI average pain score||||0.59
72611722|NCT01928849|144752351|OTHER|||||||0.16|||||||Wilcoxon (Mann-Whitney)|||Comparison of BPI Interference question sum||||0.16
72611723|NCT01928849|144752352|OTHER|||||||0.35|||||||Wilcoxon (Mann-Whitney)|||||||0.35
72611724|NCT01928849|144752353|OTHER|||||||0.42|||||||Wilcoxon (Mann-Whitney)|||Comparison of DVPRS numeric pain score||||0.42
72611725|NCT01928849|144752353|OTHER|||||||0.19|||||||Wilcoxon (Mann-Whitney)|||Comparison of DVPRS supplemental question sum||||0.19
72418925|NCT02954354|144347979|SUPERIORITY|||||||0.2144||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||168 hours||||0.2144
72611726|NCT01928849|144752354|OTHER|||||||0.27|||||||Wilcoxon (Mann-Whitney)|||Comparison of RASS postoperative hours 0-24||||0.27
72611727|NCT01928849|144752354|OTHER|||||||0.26|||||||Wilcoxon (Mann-Whitney)|||Comparison of RASS postoperative hours 24-48||||0.26
72611728|NCT00297167|144752371|SUPERIORITY_OR_OTHER||Least Square (LS) Mean Difference|-25.52|||<|0.001|TWO_SIDED|95.0|-31.73|-19.32|||ANOVA|||P-Value was calculated using analysis of variance (ANOVA) model which included main effects for treatment and sequence and participant nested in sequence as a random effect.||-19.32|-31.73|<0.001
72611729|NCT00297167|144752372|SUPERIORITY_OR_OTHER||LS Mean Difference|-21.5|||<|0.001|TWO_SIDED|95.0|-26.85|-16.14|||ANOVA|||P-Value was calculated using analysis of variance (ANOVA)model which included main effects for treatment and sequence and participant nested in sequence as a random effect.||-16.14|-26.85|<0.001
72611730|NCT03185208|144752387|SUPERIORITY||treatment x time interaction coefficient|0.69||||0.048|TWO_SIDED||||||Mixed Models Analysis|||||||0.048
72611731|NCT03185208|144752388|SUPERIORITY||treatment x time interaction coefficient|-0.08835||||0.78|TWO_SIDED||||||Mixed Models Analysis|||||||0.78
72611732|NCT03185208|144752389|SUPERIORITY||treatment x time interaction coefficient|0.08738||||0.8|TWO_SIDED||||||Mixed Models Analysis|||||||0.80
72611733|NCT03185208|144752391|SUPERIORITY||treatment x time interaction coefficient|0.012||||0.93|TWO_SIDED||||||Mixed Models Analysis|||||||0.93
72611734|NCT03185208|144752392|SUPERIORITY||treatment x time interaction coefficient|-351.8||||0.78|TWO_SIDED||||||Mixed Models Analysis|||||||0.78
72611735|NCT03185208|144752393|SUPERIORITY||treatment x time interaction coefficient|58.95||||0.087|TWO_SIDED||||||Mixed Models Analysis|||||||0.087
72611736|NCT02701634|144752401|SUPERIORITY|||||||0.99||||||P-value was calculated using the stratified Cochran-Mantel-Haenszel Chi-square test.|Chi-squared|||||||0.99
72611737|NCT02701634|144752406|SUPERIORITY|||||||0.67|||||||Log Rank|||||||0.67
72611738|NCT02701634|144752407|SUPERIORITY|||||||0.33||||||P-value was calculated using the two sample proportion t-test.|t-test, 2 sided|||||||0.33
72611739|NCT02701634|144752408|SUPERIORITY|||||||0.49||||||P-value was calculated using the two sample proportion t-test.|t-test, 2 sided|||||||0.49
72611740|NCT02701634|144752409|SUPERIORITY||Hazard Ratio (HR)|1.09||||0.8|TWO_SIDED|95.0|0.55|2.18||P-value was calculated using the log-rank test and stratified for disease severity and usage of calcineurin inhibitor or mycophenolate mofetil (MMF).|Log Rank||Hazard ratio was estimated from Cox regression model adjusted for treatment and stratified for disease severity and usage of calcineurin inhibitor or MMF|||2.18|0.55|0.800
72611741|NCT01186770|144752413|SUPERIORITY||Least square (LS) mean difference|2.83||||0.1692||95.0|-1.21|6.86||Threshold for significance at 0.0167 level.|ANCOVA|||Analysis was performed using analysis of covariance (ANCOVA) with treatment as effect and analysis region as covariate.||6.86|-1.21|0.1692
72418926|NCT02954354|144347979|SUPERIORITY|||||||0.0413||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||192 hours||||0.0413
72611742|NCT01186770|144752413|SUPERIORITY||LS mean difference|6.51||||0.0016|TWO_SIDED|95.0|2.47|10.55||Threshold for significance at 0.0167 level.|ANCOVA|||Analysis was performed using ANCOVA with treatment as effect and analysis region as covariate.||10.55|2.47|0.0016
72418927|NCT02954354|144347979|SUPERIORITY|||||||0.0409||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||216 hours||||0.0409
72611743|NCT01186770|144752413|SUPERIORITY||LS mean difference|9.13|||<|0.0001|TWO_SIDED|95.0|5.09|13.18||Threshold for significance at 0.0167 level.|ANCOVA|||Analysis was performed using ANCOVA with treatment as effect and analysis region as covariate.||13.18|5.09|< 0.0001
72611744|NCT01186770|144752414|SUPERIORITY||Odds Ratio (OR)|1.23||||0.3076|TWO_SIDED|95.0|0.82|1.84||Threshold for significance at 0.0167 level.|Regression, Logistic|||Analysis was performed using logistic regression model with treatment as effect and analysis region as covariate.||1.84|0.82|0.3076
72611745|NCT01186770|144752414|SUPERIORITY||Odds Ratio (OR)|1.54||||0.0339|TWO_SIDED|95.0|1.03|2.29||Threshold for significance at 0.0167 level.|Regression, Logistic|||Analysis was performed using logistic regression model with treatment as effect and analysis region as covariate.||2.29|1.03|0.0339
72611746|NCT01186770|144752414|SUPERIORITY||Odds Ratio (OR)|1.79||||0.0043||95.0|1.2|2.66||Threshold for significance at 0.0167 level.|Regression, Logistic|||Analysis was performed using logistic regression model with treatment as effect and analysis region as covariate.||2.66|1.20|0.0043
72611747|NCT01186770|144752415|SUPERIORITY||LS mean difference|0.09||||0.692|TWO_SIDED|95.0|-0.36|0.55||Threshold for significance at 0.0167 level.|ANCOVA|||Analysis was performed using ANCOVA model with treatment as effect and analysis region and baseline as covariates.||0.55|-0.36|0.6920
72611748|NCT01186770|144752415|SUPERIORITY||LS mean difference|0.51||||0.0274|TWO_SIDED|95.0|0.06|0.97||Threshold for significance at 0.0167 level.|ANCOVA|||Analysis was performed using ANCOVA model with treatment as effect and analysis region and baseline as covariates.||0.97|0.06|0.0274
72611749|NCT01186770|144752415|SUPERIORITY||LS mean difference|0.53||||0.0237|TWO_SIDED|95.0|0.07|0.98||Threshold for significance at 0.0167 level.|ANCOVA|||Analysis was performed using ANCOVA model with treatment as effect and analysis region and baseline as covariates.||0.98|0.07|0.0237
72611750|NCT01033136|144752421|EQUIVALENCE|To test if MCET is equivalent to CPT in decreasing PTSD symptoms, we test the equivalence of the proportion of patients whose CAPS scores decrease by 10 from baseline, by testing whether the difference in proportions between the 2 interventions ≤ to the equivalence margin δb of .20. Results are reported based on 3-month follow-up data.||||||0.3||||||The threshold for statistical significance is p \<.05 and is not adjusted for multiple comparisons.|Fisher Exact|||||||0.30
72611751|NCT01033136|144752422|OTHER|||||||0.68||||||The threshold for statistical significance is p \<.05 and is not adjusted for multiple comparisons.|Mixed Models Analysis|Degrees of freedom: 2, 54||Longitudinal analysis of PDSS scores||||0.68
72418928|NCT02954354|144347980|SUPERIORITY||Difference|-19.8|||<|0.0001||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Generalized Wilcoxon test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||||||<0.0001
72418929|NCT02954354|144347981|SUPERIORITY||Difference|-0.7||||0.4194||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Generalized Wilcoxon test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||||||0.4194
72611752|NCT01129128|144752442|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-173.0||||0.87|TWO_SIDED|95.0|||||Regression, Linear|controlled for baseline levels and performed log transformation of TNF alpha levels to account for skewed distribution of values||comparison of peak level of TNF alpha after controlling for baseline level. Based on data from 20 participants in a group, there was a power of 0.9 to detect a difference of 1000 pg/ml with a standard deviation of 700 pg/ml||||0.87
72611753|NCT01129128|144752442|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|705.0||||0.82||95.0|||||Regression, Linear|controlled for baseline levels and performed log transformation of TNF alpha levels to account for skewed distribution of values||comparison of peak level of TNF alpha after controlling for baseline level. Based on data from 20 participants in a group, there was a power of .9 to detect a difference of 1000 pg/ml with a standard deviation of 700 pg/ml||||0.82
72611754|NCT01129128|144752443|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15793.0||||0.82||95.0|||||Regression, Linear|controlled for baseline levels and performed log transformation of IL-6 levels to account for skewed distribution of values||||||0.82
72611755|NCT01129128|144752443|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|23472.0||||0.68||95.0|||||Regression, Linear|controlled for baseline levels and performed log transformation of IL-6 levels to account for skewed distribution of values||||||0.68
72611756|NCT01129128|144752444|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.0||||0.9||95.0|||||Regression, Linear|controlled for baseline levels and performed log transformation of Interferon gamma levels to account for skewed distribution of values||||||0.90
72611757|NCT01129128|144752444|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.0||||0.76||95.0|||||Regression, Linear|controlled for baseline levels and performed log transformation of Interferon gamma levels to account for skewed distribution of values||||||0.76
72611758|NCT01129128|144752445|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5||||0.98||95.0|||||Regression, Linear|controlled for baseline levels||||||0.98
72611759|NCT01129128|144752445|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|39.0||||0.34||95.0|||||Regression, Linear|controlled for baseline levels||||||0.34
72611760|NCT04497883|144752447|EQUIVALENCE|Analysis was performed with Equivalence Acceptance Range for 90% Confidence Interval (CI) as 80.00% - 125.00%.|% Ratio of Geometric least square means|110.41|||||TWO_SIDED|90.0|91.7|132.94|||ANOVA|||The comparison analysis was planned between Cohort A: Maribavir 400 mg and Cohort B: Maribavir 400 mg group participants only.||132.94|91.70|
72611761|NCT04497883|144752448|EQUIVALENCE|Analysis was performed with Equivalence Acceptance Range for 90% Confidence Interval (CI) as 80.00% - 125.00%.|% Ratio of Geometric least square means|122.49|||||TWO_SIDED|90.0|96.83|154.95|||ANOVA|||The comparison analysis was planned between Cohort A: Maribavir 400 mg and Cohort B: Maribavir 400 mg group participants only.||154.95|96.83|
72611762|NCT04497883|144752449|EQUIVALENCE|Analysis was performed with Equivalence Acceptance Range for 90% Confidence Interval (CI) as 80.00% - 125.00%.|% Ratio of Geometric least square means|125.08|||||TWO_SIDED|90.0|97.99|159.64|||ANOVA|||The comparison analysis was planned between Cohort A: Maribavir 400 mg and Cohort B: Maribavir 400 mg group participants only.||159.64|97.99|
72611763|NCT03609177|144752479|SUPERIORITY||Risk Difference (RD)|6.8|||<|0.05|TWO_SIDED|95.0|2.8|10.8|||binomial regression with identity link|||||10.8|2.8|<0.05
72611764|NCT03609177|144752480|SUPERIORITY||Risk Difference (RD)|-0.1|||<|0.05|TWO_SIDED|95.0|-0.7|0.6|||binomial regression with identity link|||||0.6|-0.7|<0.05
72611765|NCT03609177|144752481|SUPERIORITY||Risk Difference (RD)|0.7|||<|0.05|TWO_SIDED|95.0|-0.5|1.9|||binomial regression with identity link|||||1.90|-0.5|<0.05
72611766|NCT03609177|144752482|SUPERIORITY||Risk Difference (RD)|0.3|||<|0.05|TWO_SIDED|95.0|-0.4|1.0|||binomial regression with identity link|||||1.0|-0.4|<0.05
72611767|NCT05722015|144752514|NON_INFERIORITY|Non-inferiority margin is 0.8.|Geometric Mean Ratio (GMR)|1.14|||<|1e-05|TWO_SIDED|96.0|1.06|1.22|||Welch's t test|One-sided p-value was calculated using the Welch's t test.|GMR was calculated as the ratio of geometric mean (GM) of Cycle 1 AUC0-6 weeks in Arm 1 to that of Arm 2. The associated 96% confidence interval (CI) were calculated using Welch's t test.|||1.22|1.06|<0.00001
72611768|NCT05722015|144752515|NON_INFERIORITY|Non-inferiority margin is 0.8.|GMR|1.67|||<|1e-05|TWO_SIDED|94.0|1.52|1.84|||Welch's t test|One sided p-value was calculated using Welch's t test.|GMR was calculated as the ratio of GM of Cycle 3 Ctrough in Arm 1 to that of Arm 2. The associated 94% CI were calculated using Welch's t test.|||1.84|1.52|<0.00001
72611769|NCT04513366|144752530|SUPERIORITY||Risk Difference (RD)|0.44|||<|0.0001|TWO_SIDED|97.5|0.23|0.64|||Mantel Haenszel|||||0.64|0.23|<.0001
72611770|NCT04513366|144752530|SUPERIORITY||Risk Difference (RD)|0.53|||<|0.0001|TWO_SIDED|97.5|0.32|0.73|||Mantel Haenszel|||||0.73|0.32|<.0001
72611771|NCT04513366|144752531|SUPERIORITY||Least Square (LS) Mean Difference|-5.3|||<|0.001|TWO_SIDED|97.5|-7.18|-3.42|||ANCOVA|||||-3.42|-7.18|<.001
72611772|NCT04513366|144752531|SUPERIORITY||LS Mean Difference|-5.6|||<|0.001|TWO_SIDED|97.5|-7.57|-3.7|||ANCOVA|||||-3.70|-7.57|<.001
72611773|NCT04513366|144752532|SUPERIORITY||LS Mean Difference|-64.3|||<|0.001|TWO_SIDED|97.5|-87.85|-40.85|||ANCOVA|||||-40.85|-87.85|<.001
72611774|NCT04513366|144752532|SUPERIORITY||LS Mean Difference|-69.8|||<|0.001|TWO_SIDED|97.5|-92.16|-47.35|||ANCOVA|||||-47.35|-92.16|<.001
72611775|NCT04513366|144752533|SUPERIORITY||LS Mean Difference|4.5|STANDARD_ERROR_OF_MEAN|2.6||0.09|TWO_SIDED||||||Mixed Models Analysis|||||||0.090
72611776|NCT04513366|144752533|SUPERIORITY||LS Mean Difference|1.8|STANDARD_ERROR_OF_MEAN|2.5||0.472|TWO_SIDED||||||Mixed Models Analysis|||||||0.472
72611777|NCT04513366|144752534|SUPERIORITY||Difference|0.58||||0.0003|TWO_SIDED|97.5|0.25|0.91|||Chi-squared|||||0.91|0.25|0.0003
72611778|NCT04513366|144752534|SUPERIORITY||Difference|0.25||||0.1895|TWO_SIDED|97.5|-0.36|0.86|||Chi-squared|||||0.86|-0.36|0.1895
72611779|NCT04513366|144752535|SUPERIORITY||Difference|0.43||||0.0035|TWO_SIDED|97.5|0.14|0.72|||Chi-squared|||||0.72|0.14|0.0035
72611780|NCT04513366|144752535|SUPERIORITY||Difference|0.28||||0.0428|TWO_SIDED|97.5|-0.02|0.57|||Chi-squared|||||0.57|-0.02|0.0428
72611781|NCT04513366|144752536|SUPERIORITY||LS Mean Difference|-0.2||||0.517|TWO_SIDED|97.5|-1.1|0.61|||Mixed Models Analysis|||||0.61|-1.10|0.517
72611782|NCT04513366|144752536|SUPERIORITY||LS Mean Difference|0.4||||0.23|TWO_SIDED|97.5|-0.39|1.28|||Mixed Models Analysis|||||1.28|-0.39|0.230
72611783|NCT04513366|144752537|SUPERIORITY||LS Mean Difference|-0.1||||0.25|TWO_SIDED|97.5|-0.35|0.12|||Mixed Models Analysis|||||0.12|-0.35|0.250
72611784|NCT04513366|144752537|SUPERIORITY||LS Mean Difference|0.1||||0.506|TWO_SIDED|97.5|-0.16|0.29|||Mixed Models Analysis|||||0.29|-0.16|0.506
72611785|NCT04513366|144752538|SUPERIORITY||LS Mean Difference|-0.1||||0.653|TWO_SIDED|97.5|-0.55|0.37|||ANOVA|||||0.37|-0.55|0.653
72611786|NCT04513366|144752538|SUPERIORITY||LS Mean Difference|0.1||||0.629|TWO_SIDED|97.5|-0.36|0.56|||ANOVA|||||0.56|-0.36|0.629
72611787|NCT04513366|144752539|SUPERIORITY||LS Mean Difference|0.1||||0.731|TWO_SIDED|97.5|-0.4|0.54|||ANOVA|||Treatment Periods 1-3 (Months 1-3)||0.54|-0.40|0.731
72611788|NCT04513366|144752539|SUPERIORITY||LS Mean Difference|0.1||||0.583|TWO_SIDED|97.5|-0.35|0.58|||ANOVA|||Treatment Periods 1-3 (Month 1-3)||0.58|-0.35|0.583
72611789|NCT04478266|144752547|SUPERIORITY||Hazard Ratio (HR)|1.209||||0.9304|TWO_SIDED|95.0|0.939|1.557||One-sided p-value based on Stratified log-rank test. Threshold for statistical significance at 0.025 level.|Stratified Log-Rank test|Stratified on presence of De-novo metastatic disease, Postmenopausal women and Visceral metastasis according to IRT.|Letrozole + Palbociclib versus Amcenestrant + Palbociclib|A hierarchical testing procedure was used to ensure a strong control of the overall Type I error. Testing was then performed sequentially in order the outcome measures were reported and continued when previous outcome measure was statistically significant at one-sided 2.5% for the primary and the first secondary outcome.||1.557|0.939|0.9304
72611790|NCT04058717|144752564|OTHER||H-statistic|10.23||||0.017|TWO_SIDED||||||Kruskal-Wallis|||||||0.017
72611791|NCT04058717|144752565|OTHER||H-statistic|7.57||||0.056|TWO_SIDED||||||Kruskal-Wallis|||||||0.056
72611792|NCT04058717|144752566|OTHER||H-statistic|1.26||||0.74|TWO_SIDED||||||Kruskal-Wallis|||||||0.74
72611793|NCT04058717|144752567|OTHER||Slope|4.13||||0.248|TWO_SIDED||||||Kruskal-Wallis|||||||0.248
72611794|NCT04058717|144752568|OTHER||H-statistic|9.33||||0.025|TWO_SIDED||||||Kruskal-Wallis|||||||0.025
72611795|NCT04058717|144752569|OTHER|||||||0.289|||||||Fisher Exact|||||||0.289
72611796|NCT03074500|144752580|SUPERIORITY|||||||0.643|||||||Kruskal-Wallis|||Comparison of baseline values||||0.643
72611797|NCT03074500|144752580|SUPERIORITY|||||||0.018|||||||Kruskal-Wallis|||Comparison of After Treatment Values||||0.018
72611798|NCT03074500|144752580|SUPERIORITY|||||||0.027|||||||Wilcoxon (Mann-Whitney)|||Comparison of 4 week After Treatment Values||||0.027
72611799|NCT03074500|144752580|SUPERIORITY|||||||0.677||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of baseline values||||0.677
72418930|NCT02954354|144347982|SUPERIORITY|The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Difference|-23.1|||<|0.0001|||||||Generalized Wilcoxon test|Generalized Wilcoxon test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||||||<0.0001
72418931|NCT02954354|144347983|SUPERIORITY||Difference|1.3||||0.4856||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Generalized Wilcoxon test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||||||0.4856
72418932|NCT02954354|144347984|SUPERIORITY||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.3||0.7173|TWO_SIDED|95.0|-0.5|0.7||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|Analysis of covariance (ANCOVA) with baseline composite symptom score baseline (≤ 11 or ≥ 12)and region (Japan/Asia, Rest of the world) as covariates.||12 hours||0.7|-0.5|0.7173
72418933|NCT02954354|144347984|SUPERIORITY||LS Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|0.3||0.0009|TWO_SIDED|95.0|-1.7|-0.4||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|Analysis of covariance (ANCOVA) with baseline composite symptom score baseline (≤ 11 or ≥ 12)and region (Japan/Asia, Rest of the world) as covariates.||24 hours||-0.4|-1.7|0.0009
72418934|NCT02954354|144347984|SUPERIORITY||LS Mean Difference|-1.8|STANDARD_ERROR_OF_MEAN|0.3|<|0.0001|TWO_SIDED|95.0|-2.4|-1.1||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|Analysis of covariance (ANCOVA) with baseline composite symptom score baseline (≤ 11 or ≥ 12)and region (Japan/Asia, Rest of the world) as covariates.||36 hours||-1.1|-2.4|<0.0001
72418935|NCT02954354|144347984|SUPERIORITY||LS Mean Difference|-1.8|STANDARD_ERROR_OF_MEAN|0.3|<|0.0001|TWO_SIDED|95.0|-2.4|-1.2||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|Analysis of covariance (ANCOVA) with baseline composite symptom score baseline (≤ 11 or ≥ 12)and region (Japan/Asia, Rest of the world) as covariates.||48 hours||-1.2|-2.4|<0.0001
72611800|NCT03074500|144752580|SUPERIORITY|||||||0.677||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of baseline values||||0.677
72418936|NCT02954354|144347984|SUPERIORITY||LS Mean Difference|-1.4|STANDARD_ERROR_OF_MEAN|0.3|<|0.0001|TWO_SIDED|95.0|-2.0|-0.9||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|Analysis of covariance (ANCOVA) with baseline composite symptom score baseline (≤ 11 or ≥ 12)and region (Japan/Asia, Rest of the world) as covariates.||72 hours||-0.9|-2.0|<0.0001
72418937|NCT02954354|144347984|SUPERIORITY||LS Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.3||0.0001|TWO_SIDED|95.0|-1.5|-0.5||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|Analysis of covariance (ANCOVA) with baseline composite symptom score baseline (≤ 11 or ≥ 12)and region (Japan/Asia, Rest of the world) as covariates.||96 hours||-0.5|-1.5|0.0001
72418938|NCT02954354|144347984|SUPERIORITY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.2||0.1979|TWO_SIDED|95.0|-0.8|0.2||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|Analysis of covariance (ANCOVA) with baseline composite symptom score baseline (≤ 11 or ≥ 12)and region (Japan/Asia, Rest of the world) as covariates.||120 hours||0.2|-0.8|0.1979
72611801|NCT03074500|144752580|SUPERIORITY|||||||0.326||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of baseline values||||0.326
72611802|NCT03074500|144752580|SUPERIORITY|||||||0.019||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of After Treatment Values||||0.019
72611803|NCT03074500|144752580|SUPERIORITY|||||||0.014||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of After Treatment Values||||0.014
72611804|NCT03074500|144752580|SUPERIORITY|||||||0.427||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of After Treatment Values||||0.427
72611805|NCT03074500|144752580|SUPERIORITY|||||||0.023||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of 4 week After Treatment Values||||0.023
72611806|NCT03074500|144752580|SUPERIORITY|||||||0.021||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of 4 week After Treatment Values||||0.021
72326651|NCT01118780|144176639|SUPERIORITY_OR_OTHER||LS mean difference|0.38|STANDARD_ERROR_OF_MEAN|0.29||0.187|TWO_SIDED|95.0|-0.19|0.94||The p-value is for the change from baseline to Week 10 in BPI-SF Normal Work Score.|Mixed Models Analysis||LS mean difference was calculated by placebo minus duloxetine. Positive values indicated improvement over placebo.|||0.94|-0.19|0.187
72418939|NCT02954354|144347984|SUPERIORITY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.2||0.1079|TWO_SIDED|95.0|-0.8|0.1||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|Analysis of covariance (ANCOVA) with baseline composite symptom score baseline (≤ 11 or ≥ 12)and region (Japan/Asia, Rest of the world) as covariates.||144 hours||0.1|-0.8|0.1079
72418940|NCT02954354|144347984|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.2||0.5805|TWO_SIDED|95.0|-0.6|0.3||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|Analysis of covariance (ANCOVA) with baseline composite symptom score baseline (≤ 11 or ≥ 12)and region (Japan/Asia, Rest of the world) as covariates.||168 hours||0.3|-0.6|0.5805
72418941|NCT02954354|144347984|SUPERIORITY||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.2||0.8057|TWO_SIDED|95.0|-0.4|0.5||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|Analysis of covariance (ANCOVA) with baseline composite symptom score baseline (≤ 11 or ≥ 12)and region (Japan/Asia, Rest of the world) as covariates.||192 hours||0.5|-0.4|0.8057
72611807|NCT03074500|144752580|SUPERIORITY|||||||0.545||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of 4 week After Treatment Value||||0.545
72611808|NCT03074500|144752580|SUPERIORITY|||||||0.004|||||||Friedman's two-way analysis of variance|||||||0.004
72611809|NCT03074500|144752580|SUPERIORITY|||||||0.67|||||||Friedman's two-way analysis of variance|||||||0.670
72611810|NCT03074500|144752580|SUPERIORITY|||||||0.192|||||||Friedman's two-way analysis of variance|||||||0.192
72418942|NCT02954354|144347984|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.3||0.9525|TWO_SIDED|95.0|-0.6|0.6||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|Analysis of covariance (ANCOVA) with baseline composite symptom score baseline (≤ 11 or ≥ 12)and region (Japan/Asia, Rest of the world) as covariates.||216 hours||0.6|-0.6|0.9525
72418943|NCT02954354|144347985|SUPERIORITY||LS Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|0.3||0.4091|TWO_SIDED|95.0|-0.3|0.8||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|Analysis of covariance (ANCOVA) with baseline composite symptom score baseline (≤ 11 or ≥ 12)and region (Japan/Asia, Rest of the world) as covariates.||12 hours||0.8|-0.3|0.4091
72611811|NCT03074500|144752581|SUPERIORITY|||||||0.633|||||||Kruskal-Wallis|||Comparison of Before Treatment Values||||0.633
72418944|NCT02954354|144347985|SUPERIORITY||LS Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|0.3||0.3073|TWO_SIDED|95.0|-0.3|0.8||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|Analysis of covariance (ANCOVA) with baseline composite symptom score baseline (≤ 11 or ≥ 12)and region (Japan/Asia, Rest of the world) as covariates.||24 hours||0.8|-0.3|0.3073
72418945|NCT02954354|144347985|SUPERIORITY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.3||0.3465|TWO_SIDED|95.0|-0.8|0.3||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|Analysis of covariance (ANCOVA) with baseline composite symptom score baseline (≤ 11 or ≥ 12)and region (Japan/Asia, Rest of the world) as covariates.||36 hours||0.3|-0.8|0.3465
72611812|NCT03074500|144752581|SUPERIORITY|||||||0.282|||||||Kruskal-Wallis|||Comparison of After Treatment Values||||0.282
72611813|NCT03074500|144752581|SUPERIORITY|||||||0.015|||||||Kruskal-Wallis|||Comparison of 4 week After Treatment Values||||0.015
72611814|NCT03074500|144752581|SUPERIORITY|||||||0.677||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of Before Treatment Values||||0.677
72611815|NCT03074500|144752581|SUPERIORITY|||||||0.344||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of Before Treatment Values||||0.344
72611816|NCT03074500|144752581|SUPERIORITY|||||||0.596||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of Before Treatment Values||||0.596
72611817|NCT03074500|144752581|SUPERIORITY|||||||0.161||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of After Treatment Values||||0.161
72611818|NCT03074500|144752581|SUPERIORITY|||||||0.257||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of After Treatment Values||||0.257
72611819|NCT03074500|144752581|SUPERIORITY|||||||0.449||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of After Treatment Values||||0.449
72611820|NCT03074500|144752581|SUPERIORITY|||||||0.013||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of 4 week After Treatment Values||||0.013
72611821|NCT03074500|144752581|SUPERIORITY|||||||0.019||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of 4 week After Treatment Values||||0.019
72611822|NCT03074500|144752581|SUPERIORITY|||||||0.325||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of 4 week After Treatment Values||||0.325
72611823|NCT03074500|144752581|SUPERIORITY|||||||0.003|||||||Friedman's two-way analysis of variance|||||||0.003
72611824|NCT03074500|144752581|SUPERIORITY|||||||0.323|||||||Friedman's two-way analysis of variance|||||||0.323
72611825|NCT03074500|144752581|SUPERIORITY|||||||0.641|||||||Friedman's two-way analysis of variance|||||||0.641
72611826|NCT03074500|144752582|SUPERIORITY|||||||0.715|||||||Kruskal-Wallis|||Comparison of Baseline Values||||0.715
72611827|NCT03074500|144752582|SUPERIORITY|||||||0.227|||||||Kruskal-Wallis|||Comparison of After Treatment Values||||0.227
72611828|NCT03074500|144752582|SUPERIORITY|||||||0.012|||||||Kruskal-Wallis|||Comparison of 4 week After Treatment Values||||0.012
72418946|NCT02954354|144347985|SUPERIORITY||LS Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|0.2||0.4285|TWO_SIDED|95.0|-0.3|0.7||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|Analysis of covariance (ANCOVA) with baseline composite symptom score baseline (≤ 11 or ≥ 12)and region (Japan/Asia, Rest of the world) as covariates.||48 hours||0.7|-0.3|0.4285
72611829|NCT03074500|144752582|SUPERIORITY|||||||0.907||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of Baseline Values||||0.907
72611830|NCT03074500|144752582|SUPERIORITY|||||||0.482||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of Baseline Values||||0.482
72611831|NCT03074500|144752582|SUPERIORITY|||||||0.485||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of Baseline Values||||0.485
72611832|NCT03074500|144752582|SUPERIORITY|||||||0.129||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of After Treatment Values||||0.129
72611833|NCT03074500|144752582|SUPERIORITY|||||||0.12||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of After Treatment Values||||0.12
72611834|NCT03074500|144752582|SUPERIORITY|||||||0.935||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of After Treatment Values||||0.935
72611835|NCT03074500|144752582|SUPERIORITY|||||||0.002||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of 4 week After Treatment Values||||0.002
72611836|NCT03074500|144752582|SUPERIORITY|||||||0.036||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of 4 week After Treatment Values||||0.036
72611837|NCT03074500|144752582|SUPERIORITY|||||||0.056||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of 4 week After Treatment Values||||0.056
72611838|NCT03074500|144752582|SUPERIORITY|||||||0.016|||||||Friedman's two-way analysis of variance|||||||0.016
72611839|NCT03074500|144752582|SUPERIORITY|||||||0.618|||||||Friedman's two-way analysis of variance|||||||0.618
72611840|NCT03074500|144752582|SUPERIORITY|||||||0.48|||||||Friedman's two-way analysis of variance|||||||0.48
72611841|NCT03074500|144752582|SUPERIORITY|||||||0.034|||||||Wilcoxon (Mann-Whitney)|||Comparison of immediate effect between groups||||0.034
72611842|NCT03074500|144752582|SUPERIORITY|||||||0.041|||||||Kruskal-Wallis|||Immediate effect compared to baseline||||0.041
72611843|NCT03074500|144752582|SUPERIORITY|||||||1|||||||Kruskal-Wallis|||Immediate effect compared to baseline||||1
72611844|NCT03074500|144752583|SUPERIORITY|||||||0.103|||||||Kruskal-Wallis|||Comparison of Baseline Values||||0.103
72611845|NCT03074500|144752583|SUPERIORITY|||||||0.002|||||||Kruskal-Wallis|||Comparison of After Treatment Values||||0.002
72611846|NCT03074500|144752583|SUPERIORITY|||||||0.008|||||||Kruskal-Wallis|||Comparison of 4 week After Treatment Values||||0.008
72611847|NCT03074500|144752583|SUPERIORITY|||||||0.76||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of Baseline Values||||0.76
72611848|NCT03074500|144752583|SUPERIORITY|||||||1||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of Baseline Values||||1
72611849|NCT03074500|144752583|SUPERIORITY|||||||0.056||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of Baseline Values||||0.056
72611850|NCT03074500|144752583|SUPERIORITY|||||||0.002||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of After Treatment Values||||0.002
72611851|NCT03074500|144752583|SUPERIORITY|||||||0.12||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of After Treatment Values||||0.12
72611852|NCT03074500|144752583|SUPERIORITY|||||||0.117||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of After Treatment Values||||0.117
72611853|NCT03074500|144752583|SUPERIORITY|||||||0.006||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of 4 week After Treatment Values||||0.006
72611854|NCT03074500|144752583|SUPERIORITY|||||||0.013||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of 4 week After Treatment Values||||0.013
72611855|NCT03074500|144752583|SUPERIORITY|||||||0.487||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of 4 week After Treatment Values||||0.487
72611856|NCT03074500|144752583|SUPERIORITY|||||||0.002|||||||Friedman's two-way analysis of variance|||||||0.002
72611857|NCT03074500|144752583|SUPERIORITY|||||||0.102|||||||Friedman's two-way analysis of variance|||||||0.102
72611858|NCT03074500|144752583|SUPERIORITY|||||||0.165|||||||Friedman's two-way analysis of variance|||||||0.165
72611859|NCT03074500|144752583|SUPERIORITY|||||||0.007|||||||Wilcoxon (Mann-Whitney)|||Comparison of immediate effect between groups||||0.007
72611860|NCT03074500|144752583|SUPERIORITY|||||||0.028|||||||Kruskal-Wallis|||Immediate effect compared to baseline||||0.028
72611861|NCT03074500|144752583|SUPERIORITY|||||||0.83|||||||Kruskal-Wallis|||Immediate effect compared to baseline||||0.83
72611862|NCT03074500|144752584|SUPERIORITY|||||||0.837|||||||Kruskal-Wallis|||Comparison of Baseline Values||||0.837
72611863|NCT03074500|144752584|SUPERIORITY|||||||0.215|||||||Kruskal-Wallis|||Comparison of After Treatment Values||||0.215
72611864|NCT03074500|144752584|SUPERIORITY|||||||0.078|||||||Kruskal-Wallis|||Comparison of 4 week After Treatment Values||||0.078
72611865|NCT03074500|144752584|SUPERIORITY|||||||0.699||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of Baseline Values||||0.699
72611866|NCT03074500|144752584|SUPERIORITY|||||||0.846||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of Baseline Values||||0.846
72611867|NCT03074500|144752584|SUPERIORITY|||||||0.56||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of Baseline Values||||0.56
72611868|NCT03074500|144752584|SUPERIORITY|||||||0.087||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of After Treatment Values||||0.087
72611869|NCT03074500|144752584|SUPERIORITY|||||||0.183||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of After Treatment Values||||0.183
72611870|NCT03074500|144752584|SUPERIORITY|||||||0.719||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of After Treatment Values||||0.719
72611871|NCT03074500|144752584|SUPERIORITY|||||||0.023||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of 4 week After Treatment Values||||0.023
72611872|NCT03074500|144752584|SUPERIORITY|||||||0.196||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of 4 week After Treatment Values||||0.196
72611873|NCT03074500|144752584|SUPERIORITY|||||||0.318||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of 4 week After Treatment Values||||0.318
72611874|NCT03074500|144752584|SUPERIORITY|||||||0.001|||||||Friedman's two-way analysis of variance|||||||0.001
72611875|NCT03074500|144752584|SUPERIORITY|||||||0.483|||||||Friedman's two-way analysis of variance|||||||0.483
72611876|NCT03074500|144752584|SUPERIORITY|||||||0.004|||||||Friedman's two-way analysis of variance|||||||0.004
72611877|NCT03074500|144752585|SUPERIORITY|||||||0.897|||||||Kruskal-Wallis|||Comparison of Baseline Values||||0.897
72611878|NCT03074500|144752585|SUPERIORITY|||||||0.325|||||||Kruskal-Wallis|||Comparison of After Treatment Values||||0.325
72611879|NCT03074500|144752585|SUPERIORITY|||||||0.172|||||||Kruskal-Wallis|||Comparison of 4 week After Treatment Values||||0.172
72611880|NCT03074500|144752585|SUPERIORITY|||||||0.622||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of Baseline Values||||0.622
72611881|NCT03074500|144752585|SUPERIORITY|||||||0.909||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of Baseline Values||||0.909
72611882|NCT03074500|144752585|SUPERIORITY|||||||0.79||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of Baseline Values||||0.79
72611883|NCT03074500|144752585|SUPERIORITY|||||||0.24||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of After Treatment Values||||0.24
72611884|NCT03074500|144752585|SUPERIORITY|||||||0.161||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of After Treatment Values||||0.161
72611885|NCT03074500|144752585|SUPERIORITY|||||||0.909||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of After Treatment Values||||0.909
72611886|NCT03074500|144752585|SUPERIORITY|||||||0.255||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of 4 week After Treatment Values||||0.255
72611887|NCT03074500|144752585|SUPERIORITY|||||||0.058||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of 4 week After Treatment Values||||0.058
72611888|NCT03074500|144752585|SUPERIORITY|||||||0.569||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of 4 week After Treatment Values||||0.569
72611889|NCT03074500|144752585|SUPERIORITY|||||||0.007|||||||Friedman's two-way analysis of variance|||||||0.007
72611890|NCT03074500|144752585|SUPERIORITY|||||||0.614|||||||Friedman's two-way analysis of variance|||||||0.614
72611891|NCT03074500|144752585|SUPERIORITY|||||||0.072|||||||Friedman's two-way analysis of variance|||||||0.072
72611892|NCT03074500|144752585|SUPERIORITY|||||||0.447|||||||Wilcoxon (Mann-Whitney)|||Comparison of immediate effect between groups||||0.447
72611893|NCT03074500|144752585|SUPERIORITY|||||||0.084|||||||Kruskal-Wallis|||Immediate effect compared to baseline||||0.084
72611894|NCT03074500|144752585|SUPERIORITY|||||||0.235|||||||Kruskal-Wallis|||Immediate effect compared to baseline||||0.235
72611895|NCT03074500|144752586|SUPERIORITY|||||||0.958|||||||Kruskal-Wallis|||Comparison of Baseline Values||||0.958
72611896|NCT03074500|144752586|SUPERIORITY|||||||0.597|||||||Kruskal-Wallis|||Comparison of After Treatment Values||||0.597
72611897|NCT03074500|144752586|SUPERIORITY|||||||0.518|||||||Kruskal-Wallis|||Comparison of 4 week After Treatment Values||||0.518
72611898|NCT03074500|144752586|SUPERIORITY|||||||0.88||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of Baseline Values||||0.88
72611899|NCT03074500|144752586|SUPERIORITY|||||||0.733||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of Baseline Values||||0.733
72611900|NCT03074500|144752586|SUPERIORITY|||||||1||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of Baseline Values||||1
72611901|NCT03074500|144752586|SUPERIORITY|||||||0.404||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of After Treatment Values||||0.404
72611902|NCT03074500|144752586|SUPERIORITY|||||||0.97||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of After Treatment Values||||0.97
72611903|NCT03074500|144752586|SUPERIORITY|||||||0.362||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of After Treatment Values||||0.362
72611904|NCT03074500|144752586|SUPERIORITY|||||||0.271||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of 4 week After Treatment Values||||0.271
72611905|NCT03074500|144752586|SUPERIORITY|||||||0.519||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of 4 week After Treatment Values||||0.519
72611906|NCT03074500|144752586|SUPERIORITY|||||||0.569||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of 4 week After Treatment Values||||0.569
72611907|NCT03074500|144752586|SUPERIORITY|||||||0.004|||||||Friedman's two-way analysis of variance|||||||0.004
72611908|NCT03074500|144752586|SUPERIORITY|||||||0.973|||||||Friedman's two-way analysis of variance|||||||0.973
72611909|NCT03074500|144752586|SUPERIORITY|||||||0.886|||||||Friedman's two-way analysis of variance|||||||0.886
72611910|NCT03074500|144752586|SUPERIORITY|||||||0.82|||||||Wilcoxon (Mann-Whitney)|||Comparison of immediate effect between groups||||0.82
72611911|NCT03074500|144752586|SUPERIORITY|||||||0.017|||||||Kruskal-Wallis|||Immediate effect compared to baseline||||0.017
72611912|NCT03074500|144752586|SUPERIORITY|||||||0.734|||||||Kruskal-Wallis|||Immediate effect compared to baseline||||0.734
72611913|NCT03114150|144752587|SUPERIORITY||Slope|-0.02|||<|0.05|TWO_SIDED|95.0|-0.04|0.01|||Mixed Models Analysis|Kenward-Roger adjustments for degrees of freedom|Parameter is the interaction term for the interaction of group, learning rate, and session.|We tested the prediction that learning rate would increase more so for the moderate-to-vigorous training group compared to the light intensity training group. This prediction was tested with a linear mixed model, according to our statistical analysis plan.||.01|-.04|<.05
72611914|NCT03114150|144752588|SUPERIORITY||Mean Difference (Final Values)|0.01|||<|0.05|TWO_SIDED|95.0|-0.01|0.02|||Mixed Models Analysis|Kenward-Roger adjustments for degrees of freedom|Parameter is the interaction term for the interaction of exercise condition (intensity) and session.|We tested the prediction that hippocampal-cortical functional connectivity would change more for the moderate-to-vigorous acute condition compared to the light intensity condition. This prediction was tested with a linear mixed model, according to our statistical analysis plan.||.02|-.01|<.05
72418947|NCT02954354|144347985|SUPERIORITY||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.2||0.6703|TWO_SIDED|95.0|-0.4|0.6||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|Analysis of covariance (ANCOVA) with baseline composite symptom score baseline (≤ 11 or ≥ 12)and region (Japan/Asia, Rest of the world) as covariates.||72 hours||0.6|-0.4|0.6703
72418948|NCT02954354|144347985|SUPERIORITY||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.2||0.7187|TWO_SIDED|95.0|-0.3|0.5||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|Analysis of covariance (ANCOVA) with baseline composite symptom score baseline (≤ 11 or ≥ 12)and region (Japan/Asia, Rest of the world) as covariates.||96 hours||0.5|-0.3|0.7187
72418949|NCT02954354|144347985|SUPERIORITY||LS Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|0.2||0.135|TWO_SIDED|95.0|-0.1|0.7||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|Analysis of covariance (ANCOVA) with baseline composite symptom score baseline (≤ 11 or ≥ 12)and region (Japan/Asia, Rest of the world) as covariates.||120 hours||0.7|-0.1|0.1350
72418950|NCT02954354|144347985|SUPERIORITY||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.2||0.7046|TWO_SIDED|95.0|-0.3|0.5||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|Analysis of covariance (ANCOVA) with baseline composite symptom score baseline (≤ 11 or ≥ 12)and region (Japan/Asia, Rest of the world) as covariates.||144 hours||0.5|-0.3|0.7046
72418951|NCT02954354|144347985|SUPERIORITY||LS Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|0.2||0.2765|TWO_SIDED|95.0|-0.2|0.6||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|Analysis of covariance (ANCOVA) with baseline composite symptom score baseline (≤ 11 or ≥ 12)and region (Japan/Asia, Rest of the world) as covariates.||168 hours||0.6|-0.2|0.2765
72418952|NCT02954354|144347985|SUPERIORITY||LS Mean Difference|0.4|STANDARD_ERROR_OF_MEAN|0.2||0.0274|TWO_SIDED|95.0|0.0|0.8||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|Analysis of covariance (ANCOVA) with baseline composite symptom score baseline (≤ 11 or ≥ 12)and region (Japan/Asia, Rest of the world) as covariates.||192 hours||0.8|0.0|0.0274
72418953|NCT02954354|144347985|SUPERIORITY||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.2||0.6001|TWO_SIDED|95.0|-0.3|0.6||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|Analysis of covariance (ANCOVA) with baseline composite symptom score baseline (≤ 11 or ≥ 12)and region (Japan/Asia, Rest of the world) as covariates.||216 hours||0.6|-0.3|0.6001
72418954|NCT02954354|144347986|SUPERIORITY||Difference|-17.5|||<|0.0001|TWO_SIDED|95.0|-21.1|-11.9||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Generalized Wilcoxon test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||||-11.9|-21.1|<0.0001
72418955|NCT02954354|144347987|SUPERIORITY|||||||0.9225||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Generalized Wilcoxon test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||||||0.9225
72418956|NCT02954354|144347988|SUPERIORITY|||||||0.7866||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||12 hours||||0.7866
72611915|NCT03114150|144752589|SUPERIORITY||Mean Difference (Net)|0.0|||<|0.05|TWO_SIDED|95.0|-0.03|0.02|||Mixed Models Analysis|Kenward-Roger adjustments for degrees of freedom||We tested the prediction that functional connectivity strength would increase more so for the moderate-to-vigorous training group compared to the light intensity training group. This prediction was tested with a linear mixed model, according to our statistical analysis plan.|Parameter is the interaction term for the interaction of group and session.|.02|-.03|<.05
72611916|NCT03114150|144752590|SUPERIORITY||Mean Difference (Final Values)|1.42|||<|0.05|TWO_SIDED|95.0|0.27|2.59|||Mixed Models Analysis|Residualized change model, as reported in our protocol paper.||We tested the prediction that cardiorespiratory fitness would increase more so for the moderate-to-vigorous training group compared to the light intensity training group. This prediction was tested with a linear mixed model, as reported in our protocol paper.||2.59|.27|<.05
72611917|NCT00090103|144752604|SUPERIORITY_OR_OTHER||Relative Risk Estimate|0.8||||0.18||95.0|0.58|1.11||Log-rank test with stratification by cluster.|Log Rank|||||1.11|0.58|0.18
72611918|NCT00090103|144752604|SUPERIORITY_OR_OTHER||Relative Risk Estimate|0.34|||<|0.001||95.0|0.26|0.45||Log-rank test with stratification by cluster.|Log Rank|||||0.45|0.26|<0.001
72611919|NCT00090103|144752606|SUPERIORITY_OR_OTHER|||||||0.18||95.0||||Log rank test with stratification by cluster.|Log Rank|||||||0.18
72418957|NCT02954354|144347988|SUPERIORITY||||||<|0.0001||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||24 hours||||<0.0001
72418958|NCT02954354|144347988|SUPERIORITY||||||<|0.0001||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||36 hours||||<0.0001
72418959|NCT02954354|144347988|SUPERIORITY||||||<|0.0001||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||48 hours||||<0.0001
72418960|NCT02954354|144347988|SUPERIORITY||||||<|0.0001||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||72 hours||||<0.0001
72418961|NCT02954354|144347988|SUPERIORITY|||||||0.7044||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||96 hours||||0.7044
72326652|NCT01118780|144176639|SUPERIORITY_OR_OTHER||LS mean difference|0.17|STANDARD_ERROR_OF_MEAN|0.26||0.515|TWO_SIDED|95.0|-0.34|0.68||The p-value is for the change from baseline to Week 10 in BPI-SF Relations With Other People Score.|Mixed Models Analysis||LS mean difference was calculated by placebo minus duloxetine. Positive values indicated improvement over placebo.|||0.68|-0.34|0.515
72611920|NCT00090103|144752606|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Log rank test with stratification by cluster.|Log Rank|||||||<0.001
72611921|NCT00090103|144752608|SUPERIORITY_OR_OTHER||Relative Risk Estimate|0.65|||<|0.001||95.0|0.52|0.8|||Log Rank|Log-rank test with stratification by cluster.||||0.80|0.52|<0.001
72611922|NCT00090103|144752608|SUPERIORITY_OR_OTHER||Relative Risk Estimate|0.59|||<|0.001||95.0|0.48|0.72|||Log Rank|||||0.72|0.48|<0.001
72611923|NCT00090103|144752609|SUPERIORITY_OR_OTHER|||||||0.65||95.0|||||Log Rank|Mantel-Haenszel test with stratification by cluster.||||||0.65
72611924|NCT00090103|144752609|SUPERIORITY_OR_OTHER|||||||0.1||95.0|||||Log Rank|Mantel-Hanenszel test with stratification by cluster.||||||0.10
72611925|NCT00090103|144752610|SUPERIORITY_OR_OTHER|||||||0.95||95.0|||||Log Rank|Mantel-Haenszel test with stratification by cluster.||||||0.95
72611926|NCT00090103|144752610|SUPERIORITY_OR_OTHER|||||||0.24||95.0|||||Log Rank|Mantel-Haenszel test with stratification by cluster.||||||0.24
72611927|NCT00320086|144752636|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05|||||||ANOVA|||ANOVA||||<0.05
72611928|NCT03979313|144752644|SUPERIORITY||Relative Risk Reduction (RRR)|62.15||||0.0708|TWO_SIDED|95.0|-8.57|86.8|||Poisson Model||RRR of Medi8897 versus placebo; 95% CI and p-value estimated with Poisson regression with robust variance (including stratification factors \[age at randomisation\] as covariate) obtained after multiple imputation|||86.80|-8.57|0.0708
72611929|NCT03979313|144752645|SUPERIORITY||Relative Risk Reduction (RRR)|74.53|||<|0.0001|TWO_SIDED|95.0|49.63|87.12|||Poisson Model||RRR of Medi8897 versus placebo; 95% CI and p-value estimated with Poisson regression with robust variance (including stratification factors \[age at randomisation\] as covariate) obtained after multiple imputation|||87.12|49.63|<0.0001
72611930|NCT03979313|144752646|SUPERIORITY||Relative Risk Reduction (RRR)|76.36|||<|0.0001|TWO_SIDED|95.0|62.27|85.18|||Poisson Model||RRR of Medi8897 versus placebo; 95% CI and p-value estimated with Poisson regression with robust variance (including stratification factors \[age at randomisation\] as covariate) obtained after multiple imputation|||85.18|62.27|<0.0001
72611931|NCT03979313|144752647|SUPERIORITY||Relative Risk Reduction (RRR)|76.84||||0.0002|TWO_SIDED|95.0|49.36|89.41|||Poisson Model||RRR of Medi8897 versus placebo; 95% CI and p-value estimated with Poisson regression with robust variance (including stratification factors \[age at randomisation\] as covariate) obtained after multiple imputation|||89.41|49.36|0.0002
72326653|NCT01118780|144176639|SUPERIORITY_OR_OTHER||LS mean difference|0.5|STANDARD_ERROR_OF_MEAN|0.34||0.141|TWO_SIDED|95.0|-0.17|1.18||The p-value is for the change from baseline to Week 10 in BPI-SF Sleep Score.|Mixed Models Analysis||LS mean difference was calculated by placebo minus duloxetine. Positive values indicated improvement over placebo.|||1.18|-0.17|0.141
72611932|NCT00089648|144752651|SUPERIORITY_OR_OTHER||Objective Response Rate (ORR) (percent)|23.0||||||95.0|13.2|35.5|||||ORR=proportion of subjects with confirmed CR or PR, relative to total number of subjects who received at least 1 dose of study medication, were refractory to bevacizumab, had a baseline disease assessment and had the correct histological cancer type.|||35.5|13.2|
72611933|NCT00300053|144752664|SUPERIORITY|||||||0.02|||||||ANCOVA|||Frequency of angina episodes per week 6 months after treatment.||||0.020
72611934|NCT00300053|144752664|SUPERIORITY|||||||0.035|||||||ANCOVA|||Frequency of angina episodes per week 12 months after treatment.||||0.035
72611935|NCT00300053|144752664|SUPERIORITY|||||||0.167|||||||ANCOVA|||Frequency of angina episodes per week 6 months after treatment.||||0.167
72611936|NCT00300053|144752664|SUPERIORITY|||||||0.181|||||||ANCOVA|||Frequency of angina episodes per week 12 months after treatment.||||0.181
72611937|NCT00300053|144752665|SUPERIORITY|||||||0.014|||||||ANCOVA|||Change from baseline to 6 months||||0.014
72611938|NCT00300053|144752665|SUPERIORITY|||||||0.017|||||||ANCOVA|||Change from baseline to 12 months||||0.017
72611939|NCT00300053|144752665|SUPERIORITY|||||||0.097|||||||ANCOVA|||Change from baseline to 6 months||||0.097
72611940|NCT00300053|144752665|SUPERIORITY|||||||0.134|||||||ANCOVA|||Change from baseline to 12 months||||0.134
72418962|NCT02954354|144347988|SUPERIORITY|||||||0.8512||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||120 hours||||0.8512
72418963|NCT02954354|144347988|SUPERIORITY|||||||0.8783||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||144 hours||||0.8783
72418964|NCT02954354|144347988|SUPERIORITY|||||||0.8291||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||168 hours||||0.8291
72418965|NCT02954354|144347988|SUPERIORITY|||||||0.8644||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||192 hours||||0.8644
72418966|NCT02954354|144347988|SUPERIORITY|||||||0.9312||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||216 hours||||0.9312
72418967|NCT02954354|144347989|SUPERIORITY|||||||0.2953||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||12 hours||||0.2953
72418968|NCT02954354|144347989|SUPERIORITY|||||||0.5414||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||24 hours||||0.5414
72418969|NCT02954354|144347989|SUPERIORITY|||||||0.2079||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||36 hours||||0.2079
72418970|NCT02954354|144347989|SUPERIORITY|||||||0.7771||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world)||48 hours||||0.7771
72418971|NCT02954354|144347989|SUPERIORITY|||||||0.0215||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||72 hours||||0.0215
72418972|NCT02954354|144347989|SUPERIORITY|||||||0.8033||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world)||96 hours||||0.8033
72418973|NCT02954354|144347989|SUPERIORITY|||||||0.4157||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||120 hours||||0.4157
72418974|NCT02954354|144347989|SUPERIORITY|||||||0.5908||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world)||144 hours||||0.5908
72418975|NCT02954354|144347989|SUPERIORITY|||||||0.2975||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||168 hours||||0.2975
72418976|NCT02954354|144347989|SUPERIORITY|||||||0.8644||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||192 hours||||0.8644
72418977|NCT02954354|144347989|SUPERIORITY|||||||0.5573||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.m|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||216 hours||||0.5573
72418978|NCT02954354|144347990|SUPERIORITY||LS Mean Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.08||0.2557|TWO_SIDED|95.0|-0.24|0.06||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|ANCOVA with baseline composite symptom score and region (Japan/Asia, Rest of the world) and body temperature at baseline as covariates.||12 hours||0.06|-0.24|0.2557
72418979|NCT02954354|144347990|SUPERIORITY||LS Mean Difference|-0.34|STANDARD_ERROR_OF_MEAN|0.06|<|0.0001|TWO_SIDED|95.0|-0.46|-0.22||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|ANCOVA with baseline composite symptom score and region (Japan/Asia, Rest of the world) and body temperature at baseline as covariates.||24 hours||-0.22|-0.46|<0.0001
72418980|NCT02954354|144347990|SUPERIORITY||LS Mean Difference|-0.41|STANDARD_ERROR_OF_MEAN|0.06|<|0.0001|TWO_SIDED|95.0|-0.52|-0.29||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|ANCOVA with baseline composite symptom score and region (Japan/Asia, Rest of the world) and body temperature at baseline as covariates.||36 hours||-0.29|-0.52|<0.0001
72418981|NCT02954354|144347990|SUPERIORITY||LS Mean Difference|-0.37|STANDARD_ERROR_OF_MEAN|0.05|<|0.0001|TWO_SIDED|95.0|-0.48|-0.27||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|ANCOVA with baseline composite symptom score and region (Japan/Asia, Rest of the world) and body temperature at baseline as covariates.||48 hours||-0.27|-0.48|<0.0001
72418982|NCT02954354|144347990|SUPERIORITY||LS Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.05|<|0.0001|TWO_SIDED|95.0|-0.31|-0.13||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|ANCOVA with baseline composite symptom score and region (Japan/Asia, Rest of the world) and body temperature at baseline as covariates.||72 hours||-0.13|-0.31|<0.0001
72418983|NCT02954354|144347990|SUPERIORITY||LS Mean Dfference|-0.04|STANDARD_ERROR_OF_MEAN|0.05||0.4484|TWO_SIDED|95.0|-0.13|0.06||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|ANCOVA with baseline composite symptom score and region (Japan/Asia, Rest of the world) and body temperature at baseline as covariates.||96 hours||0.06|-0.13|0.4484
72418984|NCT02954354|144347990|SUPERIORITY||LS Mean Difference|0.02|STANDARD_ERROR_OF_MEAN|0.05||0.5963|TWO_SIDED|95.0|-0.07|0.11||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|ANCOVA with baseline composite symptom score and region (Japan/Asia, Rest of the world) and body temperature at baseline as covariates.||ANCOVA with baseline composite symptom score and region (Japan/Asia, Rest of the world) and body temperature at baseline as covariates.||0.11|-0.07|0.5963
72418985|NCT02954354|144347991|SUPERIORITY||LS Mean Difference|0.11|STANDARD_ERROR_OF_MEAN|0.07||0.0937|TWO_SIDED|95.0|-0.02|0.24||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|ANCOVA with baseline composite symptom score and region (Japan/Asia, Rest of the world) and body temperature at baseline as covariates.||12 hours||0.24|-0.02|0.0937
72326654|NCT01118780|144176639|SUPERIORITY_OR_OTHER||LS mean difference|0.5|STANDARD_ERROR_OF_MEAN|0.29||0.088|TWO_SIDED|95.0|-0.07|1.07||The p-value is for the change from baseline to Week 10 in BPI-SF Enjoyment of Life Score.|Mixed Models Analysis||LS mean difference was calculated by placebo minus duloxetine. Positive values indicated improvement over placebo.|||1.07|-0.07|0.088
72418986|NCT02954354|144347991|SUPERIORITY||LS Mean Difference|0.05|STANDARD_ERROR_OF_MEAN|0.05||0.3343|TWO_SIDED|95.0|-0.05|0.16||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|ANCOVA with baseline composite symptom score and region (Japan/Asia, Rest of the world) and body temperature at baseline as covariates.||24 hours||0.16|-0.05|0.3343
72418987|NCT02954354|144347991|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.05||0.9258|TWO_SIDED|95.0|-0.09|0.1||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|ANCOVA with baseline composite symptom score and region (Japan/Asia, Rest of the world) and body temperature at baseline as covariates.||36 hours||0.10|-0.09|0.9258
72418988|NCT02954354|144347991|SUPERIORITY||LS Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.04||0.6574|TWO_SIDED|95.0|-0.1|0.06||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|ANCOVA with baseline composite symptom score and region (Japan/Asia, Rest of the world) and body temperature at baseline as covariates.||48 hours||0.06|-0.10|0.6574
72611941|NCT03183908|144752672|NON_INFERIORITY|The one-sided non-inferiority test with the alpha level set at 0.025 and non-inferiority margin of 5%, stratified by site.|Difference in proportions|-2.7|||||TWO_SIDED|95.0|-5.8|0.4|||||The upper bound of a stratified Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting of the difference was used.|The null hypothesis is allV3 is inferior (i.e., allV3 will have higher rates of moderate/severe injection site pain) to IIV3-HD in regards to the proportion of subjects having moderate or severe injection site pain in the first week post vaccination.||0.4|-5.8|
72611942|NCT03183908|144752674|OTHER|The comparison of the number of participants with reported SAEs regardless of relationship to study product were made using 95% confidence intervals. Results were reported using exact binomial confidence intervals.|Comparison of Frequencies|2.38|||||TWO_SIDED|95.0|1.09|4.47||||||||4.47|1.09|
72326655|NCT01118780|144176640|SUPERIORITY_OR_OTHER||LS mean difference|-5.76|STANDARD_ERROR_OF_MEAN|1.87||0.002|TWO_SIDED|95.0|-9.4|-2.1|||ANCOVA||LS mean difference was calculated by placebo minus duloxetine. Negative values indicated improvement over placebo.|||-2.1|-9.4|0.002
72326656|NCT01118780|144176642|SUPERIORITY_OR_OTHER||LS mean difference|1.13|STANDARD_ERROR_OF_MEAN|0.43||0.01|TWO_SIDED|95.0|0.27|1.98||The p-value is for the change from baseline to Week 10 in SDS for Work/School Impairment Score.|Mixed Models Analysis||LS mean difference was calculated by placebo minus duloxetine. Positive values indicated improvement over placebo.|||1.98|0.27|0.010
72418989|NCT02954354|144347991|SUPERIORITY||LS Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.04||0.852|TWO_SIDED|95.0|-0.09|0.07||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|ANCOVA with baseline composite symptom score and region (Japan/Asia, Rest of the world) and body temperature at baseline as covariates.||72 hours||0.07|-0.09|0.8520
72418990|NCT02954354|144347991|SUPERIORITY||LS Mean Difference|0.03|STANDARD_ERROR_OF_MEAN|0.04||0.4532|TWO_SIDED|95.0|-0.05|0.11||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|ANCOVA with baseline composite symptom score and region (Japan/Asia, Rest of the world) and body temperature at baseline as covariates.||96 hours||0.11|-0.05|0.4532
72418991|NCT02954354|144347991|SUPERIORITY||LS Mean Difference|0.05|STANDARD_ERROR_OF_MEAN|0.04||0.157|TWO_SIDED|95.0|-0.02|0.13||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|ANCOVA with baseline composite symptom score and region (Japan/Asia, Rest of the world) and body temperature at baseline as covariates.||120 hours||0.13|-0.02|0.1570
72418992|NCT02954354|144347992|SUPERIORITY||Difference|-23.1||||0.0001||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Generalized Wilcoxon test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Cough||||0.0001
72326657|NCT01118780|144176642|SUPERIORITY_OR_OTHER||LS mean difference|0.9|STANDARD_ERROR_OF_MEAN|0.29||0.002|TWO_SIDED|95.0|0.32|1.48||The p-value is for the change from baseline to Week 10 in SDS for Social Life/Leisure Activities Impairment Score.|Mixed Models Analysis||LS mean difference was calculated by placebo minus duloxetine. Positive values indicated improvement over placebo.|||1.48|0.32|0.002
72611943|NCT03183908|144752674|OTHER|The comparison of the number of participants with reported SAEs regardless of relationship to study product were made using 95% confidence intervals. Results were reported using exact binomial confidence intervals.|Comparison of Frequencies|0.79|||||TWO_SIDED|95.0|0.16|2.23||||||||2.23|0.16|
72611944|NCT03183908|144752675|NON_INFERIORITY|This objective will be assessed using a one-sided noninferiority test with the alpha level set at 0.025 and noninferiority margin of 10%. The null hypothesis is the allV3 H3N2 seroconversion rate is inferior to IIV3-HD seroconversion rate.|Difference in Proportions|-0.0579||||0.1245|ONE_SIDED|97.5|-0.1291||||Cochran-Mantel-Haenszel||The directional comparison was the lower bound of the confidence interval using a 10% non-inferiority margin.||||-.1291|0.1245
72611945|NCT03183908|144752676|NON_INFERIORITY|Site-stratified, 5% noninferiority test with a one-sided alpha at the 0.01 level to adjust for multiple comparisons.|Difference in proportions|-1.9|||||TWO_SIDED|98.0|-5.0|1.0|||||The upper bound of a stratified Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting of the difference was used.|Redness||1.0|-5.0|
72611946|NCT03183908|144752676|NON_INFERIORITY|Site-stratified, 5% noninferiority test with a one-sided alpha at the 0.01 level to adjust for multiple comparisons.|Difference in proportions|0.5|||||TWO_SIDED|98.0|-3.1|4.3|||||The upper bound of a stratified Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting of the difference was used.|Shoulder Pain||4.3|-3.1|
72611947|NCT03183908|144752676|NON_INFERIORITY|Site-stratified, 5% noninferiority test with a one-sided alpha at the 0.01 level to adjust for multiple comparisons.|Difference in proportions|-3.7|||||TWO_SIDED|98.0|-7.5|-0.3|||||The upper bound of a stratified Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting of the difference was used.|Swelling||-0.3|-7.5|
72611948|NCT03183908|144752676|NON_INFERIORITY|Site-stratified, 5% noninferiority test with a one-sided alpha at the 0.01 level to adjust for multiple comparisons.|Difference in proportions|1.6|||||TWO_SIDED|98.0|-2.7|5.9|||||The upper bound of a stratified Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting of the difference was used.|Tenderness||5.9|-2.7|
72611949|NCT03183908|144752677|NON_INFERIORITY|Site-stratified, 5% noninferiority test with a one-sided alpha at the 0.025 level.|Difference in proportions|-2.4|||||TWO_SIDED|95.0|-5.2|0.2|||||The upper bound of a stratified Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting of the difference was used.|Redness||0.2|-5.2|
72611950|NCT03183908|144752677|NON_INFERIORITY|Site-stratified, 5% noninferiority test with a one-sided alpha at the 0.025 level.|Difference in proportions|1.3|||||TWO_SIDED|95.0|-2.3|4.9|||||The upper bound of a stratified Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting of the difference was used.|Shoulder Pain||4.9|-2.3|
72611951|NCT03183908|144752677|NON_INFERIORITY|Site-stratified, 5% noninferiority test with a one-sided alpha at the 0.025 level.|Difference in proportions|-4.5|||||TWO_SIDED|95.0|-8.1|-1.1|||||The upper bound of a stratified Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting of the difference was used.|Swelling||-1.1|-8.1|
72326658|NCT01118780|144176642|SUPERIORITY_OR_OTHER||LS mean difference|1.21|STANDARD_ERROR_OF_MEAN|0.3|<|0.001|TWO_SIDED|95.0|0.61|1.81||The p-value is for the change from baseline to Week 10 in SDS for Family/Home Management Impairment Score.|Mixed Models Analysis||LS mean difference was calculated by placebo minus duloxetine. Positive values indicated improvement over placebo.|||1.81|0.61|<0.001
72326659|NCT01118780|144176643|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The p-value is for percentage of participants having HAMA response at Week 10 and was adjusted for pooled investigator.|Cochran-Mantel-Haenszel|||||||<0.001
72326660|NCT01118780|144176643|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The p-value is for percentage of participants having remission (HAMA Total Score ≤7) at Week 10 and was adjusted for pooled investigator.|Cochran-Mantel-Haenszel|||||||<0.001
72611952|NCT03183908|144752677|NON_INFERIORITY|Site-stratified, 5% noninferiority test with a one-sided alpha at the 0.025 level.|Difference in proportions|1.6|||||TWO_SIDED|95.0|-2.7|5.9|||||The upper bound of a stratified Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting of the difference was used.|Tenderness||5.9|-2.7|
72418993|NCT02954354|144347992|SUPERIORITY||Difference|-9.0||||0.0298||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Generalized Wilcoxon test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Sore throat||||0.0298
72418994|NCT02954354|144347992|SUPERIORITY||Difference|-11.8||||0.0297||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Generalized Wilcoxon test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Headache||||0.0297
72418995|NCT02954354|144347992|SUPERIORITY||Difference|-20.7||||0.0027||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Generalized Wilcoxon test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Nasal Congestion||||0.0027
72418996|NCT02954354|144347992|SUPERIORITY||Difference|-4.9||||0.0003||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Generalized Wilcoxon test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world)||Feverishness or chills||||0.0003
72418997|NCT02954354|144347992|SUPERIORITY||Difference|-8.1||||0.0094||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Generalized Wilcoxon test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Muscle or joint pain||||0.0094
72418998|NCT02954354|144347992|SUPERIORITY||Difference|-15.3||||0.0007||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Generalized Wilcoxon test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Fatigue||||0.0007
72418999|NCT02954354|144347993|SUPERIORITY||Difference|6.8||||0.6623||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Generalized Wilcoxon test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Cough||||0.6623
72419000|NCT02954354|144347993|SUPERIORITY||Difference|1.8||||0.8184||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Generalized Wilcoxon test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Sore throat||||0.8184
72419001|NCT02954354|144347993|SUPERIORITY||Difference|1.3||||0.9989||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Generalized Wilcoxon test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Headache||||0.9989
72419002|NCT02954354|144347993|SUPERIORITY||Difference|1.7||||0.3706||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Generalized Wilcoxon test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Nasal congestion||||0.3706
72419003|NCT02954354|144347993|SUPERIORITY||Difference|-0.1||||0.9973||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Generalized Wilcoxon test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Feverishness or chills||||0.9973
72419004|NCT02954354|144347993|SUPERIORITY||Difference|-0.7||||0.676||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Generalized Wilcoxon test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Muscle or joint pain||||0.6760
72611953|NCT03183908|144752677|NON_INFERIORITY|Site-stratified, 5% noninferiority test with a one-sided alpha at the 0.025 level.|Difference in proportions|-3.1|||||TWO_SIDED|95.0|-6.9|0.4|||||The upper bound of a stratified Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting of the difference was used.|Injection Site Pain||0.4|-6.9|
72611954|NCT03183908|144752678|NON_INFERIORITY|Site-stratified, 5% noninferiority test with a one-sided alpha at the 0.025 level.|Difference in proportions|0.1|||||TWO_SIDED|95.0|-7.3|7.3|||||The upper bound of a stratified Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting of the difference was used.|Redness||7.3|-7.3|
72419005|NCT02954354|144347993|SUPERIORITY||Difference|2.2||||0.4241||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Generalized Wilcoxon test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Fatigue||||0.4241
72419006|NCT02954354|144347994|SUPERIORITY|The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Difference|-39.5||||0.0563|||||||Generalized Wilcoxon test|Generalized Wilcoxon test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||||||0.0563
72419007|NCT02954354|144347995|SUPERIORITY||Difference|-0.6||||0.7176||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Generalized Wilcoxon test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||||||0.7176
72419008|NCT02954354|144347996|SUPERIORITY|||||||0.6728||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Fisher Exact|||Any Complications||||0.6728
72419009|NCT02954354|144347997|SUPERIORITY|||||||0.2217||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Fisher Exact|||Any Complications||||0.2217
72419010|NCT00514735|144348036|SUPERIORITY_OR_OTHER||||||<|0.0001||||||In order to maintain the overall level of significance at the α=0.025 level after a planned interim analysis using α=0.003, this test will actually be performed using an adjusted α=0.0245 at the completion of the study.|Chi-squared|||"H0: Pa ≤ Pm Ha: Pa \> Pm~where Pa is the proportion of successfully treated subjects in the ablation management arm and Pm is the proportion of successfully treated subjects in the optimal medical management/drug therapy arm."||||<0.0001
72419011|NCT00514735|144348037|SUPERIORITY_OR_OTHER|||||||0.1427||||||An exact, one-sample binomial test was conducted at a one-sided α=0.025 level of significance.|Fisher Exact|||"H0: Pa ≥ 0.16 Ha: Pa \< 0.16~where Pa is the proportion of acute safety failures in the ablation management arm."||||0.1427
72419012|NCT00514735|144348038|NON_INFERIORITY_OR_EQUIVALENCE|This objective was not statistically powered. The non-inferiority chronic safety margin was 0.06.||||||0.0033|||||||t-test, 1 sided|||"H0: Pa ≥ Pm + 0.06 Ha: Pa \< Pm + 0.06~where Pa is the proportion of failed subjects in the ablation management arm and Pm is the proportion of failed subjects in the optimal medical management/drug therapy arm."||||0.0033
72419013|NCT00514735|144348040|SUPERIORITY_OR_OTHER|||||||0.35|||||||ANOVA|||"H0: μa = μm Ha: μa ≠ μm~where μa is the change of LAD from baseline to 6 month in Ablation Management arm, and μm is the change of LAD from baseline to 6 month in Medical Management arm."||||0.35
72419014|NCT00514735|144348041|SUPERIORITY_OR_OTHER|||||||0.06|||||||ANOVA|||"H0: μa = μm Ha: μa ≠ μm~where μa is the change of LVEF from baseline to 6 month in Ablation Management arm, and μm is the change of LVEF from baseline to 6 month in Medical Management arm."||||0.06
72419015|NCT00514735|144348042|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||<0.0001
72419016|NCT00514735|144348043|SUPERIORITY_OR_OTHER||||||<|0.025|||||||Mixed Models Analysis|||||||<0.025
72419017|NCT02170025|144348074|OTHER||Bayesian analysis|-1.3|||||TWO_SIDED|90.0|-8.7|6.0||||||Treatment effect describes the difference in outcomes between 0.5 mg riociguat and placebo on Day 14. This was an exploratory analysis. For sample size determination a probabilistic assessment on predicted point estimates and width of credible intervals was performed.||6.0|-8.7|
72419018|NCT02170025|144348074|OTHER||Bayesian analysis|-5.0|||||TWO_SIDED|90.0|-12.4|2.4||||||Treatment effect describes the difference in outcomes between 1.0 mg riociguat and placebo on Day 28. This was an exploratory analysis. For sample size determination a probabilistic assessment on predicted point estimates and width of credible intervals was performed.||2.4|-12.4|
72419019|NCT00572195|144348076|OTHER||Wilson score interval|77.0|||||TWO_SIDED|95.0|71.1|81.9|||||The value is for all serious adverse events, regardless of device relation.||95% confidence interval estimated using the Wilson score interval|81.9|71.1|
72611955|NCT03183908|144752678|NON_INFERIORITY|Site-stratified, 5% noninferiority test with a one-sided alpha at the 0.025 level.|Difference in proportions|-2.3|||||TWO_SIDED|95.0|-9.5|5.7|||||The upper bound of a stratified Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting of the difference was used.|Shoulder Pain||5.7|-9.5|
72611956|NCT03183908|144752678|NON_INFERIORITY|Site-stratified, 5% noninferiority test with a one-sided alpha at the 0.025 level.|Difference in proportions|-1.2|||||TWO_SIDED|95.0|-8.6|6.1|||||The upper bound of a stratified Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting of the difference was used.|Swelling||6.1|-8.6|
72611957|NCT03183908|144752678|NON_INFERIORITY|Site-stratified, 5% noninferiority test with a one-sided alpha at the 0.025 level.|Difference in proportions|1.4|||||TWO_SIDED|95.0|-5.7|8.3|||||The upper bound of a stratified Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting of the difference was used.|Tenderness||8.3|-5.7|
72611958|NCT03183908|144752678|NON_INFERIORITY|Site-stratified, 5% noninferiority test with a one-sided alpha at the 0.025 level.|Difference in proportions|-1.2|||||TWO_SIDED|95.0|-7.9|5.4|||||The upper bound of a stratified Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting of the difference was used.|Injection Site Pain||5.4|-7.9|
72611959|NCT03183908|144752679|NON_INFERIORITY|Site-stratified, 5% noninferiority test with a one-sided alpha at the 0.01 level to adjust for multiple comparisons.|Difference in proportions|1.8|||||TWO_SIDED|98.0|-1.7|5.4|||||The upper bound of a stratified Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting of the difference was used.|Arthralgia||5.4|-1.7|
72611960|NCT03183908|144752679|NON_INFERIORITY|Site-stratified, 5% noninferiority test with a one-sided alpha at the 0.01 level to adjust for multiple comparisons.|Difference in proportions|-0.5|||||TWO_SIDED|98.0|-2.8|2.3|||||The upper bound of a stratified Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting of the difference was used.|Chills/Shivering||2.3|-2.8|
72611961|NCT03183908|144752679|NON_INFERIORITY|Site-stratified, 5% noninferiority test with a one-sided alpha at the 0.01 level to adjust for multiple comparisons.|Difference in proportions|-1.1|||||TWO_SIDED|98.0|-4.0|1.5|||||The upper bound of a stratified Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting of the difference was used.|Diarrhea||1.5|-4.0|
72611962|NCT03183908|144752679|NON_INFERIORITY|Site-stratified, 5% noninferiority test with a one-sided alpha at the 0.01 level to adjust for multiple comparisons.|Difference in proportions|3.2|||||TWO_SIDED|98.0|-0.8|7.3|||||The upper bound of a stratified Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting of the difference was used.|Fatigue||7.3|-0.8|
72611963|NCT03183908|144752679|NON_INFERIORITY|Site-stratified, 5% noninferiority test with a one-sided alpha at the 0.01 level to adjust for multiple comparisons.|Difference in proportions|0.5|||||TWO_SIDED|98.0|-2.5|2.0|||||The upper bound of a stratified Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting of the difference was used.|Fever||2.0|-2.5|
72611964|NCT03183908|144752679|NON_INFERIORITY|Site-stratified, 5% noninferiority test with a one-sided alpha at the 0.01 level to adjust for multiple comparisons.|Difference in proportions|-0.3|||||TWO_SIDED|98.0|-3.0|2.4|||||The upper bound of a stratified Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting of the difference was used.|Headache||2.4|-3.0|
72611965|NCT03183908|144752679|NON_INFERIORITY|Site-stratified, 5% noninferiority test with a one-sided alpha at the 0.01 level to adjust for multiple comparisons.|Difference in proportions|1.8|||||TWO_SIDED|98.0|-1.7|5.4|||||The upper bound of a stratified Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting of the difference was used.|Malaise||5.4|-1.7|
72611966|NCT03183908|144752679|NON_INFERIORITY|Site-stratified, 5% noninferiority test with a one-sided alpha at the 0.01 level to adjust for multiple comparisons.|Difference in proportions|0.5|||||TWO_SIDED|98.0|-3.3|4.4|||||The upper bound of a stratified Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting of the difference was used.|Myalgia||4.4|-3.3|
72611967|NCT03183908|144752679|NON_INFERIORITY|Site-stratified, 5% noninferiority test with a one-sided alpha at the 0.01 level to adjust for multiple comparisons.|Difference in proportions|-0.8|||||TWO_SIDED|98.0|-3.1|1.6|||||The upper bound of a stratified Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting of the difference was used.|Nausea||1.6|-3.1|
72611968|NCT03183908|144752679|NON_INFERIORITY|Site-stratified, 5% noninferiority test with a one-sided alpha at the 0.01 level to adjust for multiple comparisons.|Difference in proportions|0.0|||||TWO_SIDED|98.0|-1.8|1.8|||||The upper bound of a stratified Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting of the difference was used.|Vomiting||1.8|-1.8|
72611969|NCT03183908|144752680|NON_INFERIORITY|Site-stratified, 5% noninferiority test with a one-sided alpha at the 0.025 level.|Difference in proportions|2.3|||||TWO_SIDED|95.0|-1.1|5.8|||||The upper bound of a stratified Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting of the difference was used.|Arthralgia||5.8|-1.1|
72611970|NCT03183908|144752680|NON_INFERIORITY|Site-stratified, 5% noninferiority test with a one-sided alpha at the 0.025 level.|Difference in proportions|-0.7|||||TWO_SIDED|95.0|-3.0|2.0|||||The upper bound of a stratified Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting of the difference was used.|Chills/Shivering||2.0|-3.0|
72611971|NCT03183908|144752680|NON_INFERIORITY|Site-stratified, 5% noninferiority test with a one-sided alpha at the 0.025 level.|Difference in proportions|-0.7|||||TWO_SIDED|95.0|-3.5|1.8|||||The upper bound of a stratified Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting of the difference was used.|Diarrhea||1.8|-3.5|
72611972|NCT03183908|144752680|NON_INFERIORITY|Site-stratified, 5% noninferiority test with a one-sided alpha at the 0.025 level.|Difference in proportions|2.9|||||TWO_SIDED|95.0|-1.1|7.0|||||The upper bound of a stratified Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting of the difference was used.|Fatigue||7.0|-1.1|
72419020|NCT00572195|144348077|OTHER||||||<|0.05||||||For all 6-month periods, from 6 months through 9 years post-implant, p \<0.05.|Wilcoxon Signed Rank Test|||||||<0.05
72419021|NCT00572195|144348079|OTHER||GEE estimated intercept|48.0|||<|0.0001|TWO_SIDED|95.0|46.8|49.2|||Generalized estimating equation (GEE)|||||49.2|46.8|<0.0001
72419022|NCT00572195|144348079|OTHER||Slope|0.0||||0.6729|TWO_SIDED|95.0|-0.2|0.1|||Generalized estimating equation (GEE)|||||0.1|-0.2|0.6729
72419023|NCT03896009|144348111|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
72419024|NCT03896009|144348112|SUPERIORITY|||||||0.002|||||||Chi-squared|||||||0.002
72419025|NCT01490502|144348124|SUPERIORITY|||||||0.6|||||||Log Rank|||||||0.60
72419026|NCT01490502|144348124|SUPERIORITY||Hazard Ratio (HR)|1.17||||0.57|TWO_SIDED|95.0|0.67|2.05|||Regression, Cox|||||2.05|0.67|0.57
72419027|NCT01490502|144348125|OTHER|||||||0.07|||||||Andersen Gill model for recurrent events|||||||0.07
72419028|NCT01490502|144348126|SUPERIORITY||Rate Ratio|1.8||||0.07|TWO_SIDED|95.0|0.94|3.45|||Negative Binomial Model|||||3.45|0.94|0.07
72419029|NCT01490502|144348127|SUPERIORITY||Rate Ratio|1.47||||0.14|TWO_SIDED|95.0|0.88|2.46|||Negative Binomial Model|||||2.46|0.88|0.14
72419030|NCT01490502|144348128|SUPERIORITY|||||||0.6|||||||Log Rank|||||||0.60
72419031|NCT01490502|144348129|SUPERIORITY|||||||0.2|||||||Mixed Models Analysis|||The average rate of change in MSFC Z-score over time was analyzed using a linear mixed-effects model with unstructured covariance structure and random intercepts. The p-value is a test of whether there is a difference in the rate of change in the MSFC Z-score between treatment arms.||||0.20
72419032|NCT01490502|144348130|SUPERIORITY|||||||0.67|||||||Mixed Models Analysis|||Rate of change in 2.5% low-contrast acuity was analyzed using a linear mixed effects model with unstructured covariance structure and random intercepts. The p-value is a test of whether there is a difference in the rate of change in low-contrast acuity between treatment arms.||||0.67
72611973|NCT03183908|144752680|NON_INFERIORITY|Site-stratified, 5% noninferiority test with a one-sided alpha at the 0.025 level.|Difference in proportions|-1.0|||||TWO_SIDED|95.0|-3.0|-0.4|||||The upper bound of a stratified Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting of the difference was used.|Fever||-0.4|-3.0|
72611974|NCT03183908|144752680|NON_INFERIORITY|Site-stratified, 5% noninferiority test with a one-sided alpha at the 0.025 level.|Difference in proportions|-0.4|||||TWO_SIDED|95.0|-3.2|2.4|||||The upper bound of a stratified Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting of the difference was used.|Headache||2.4|-3.2|
72611975|NCT03183908|144752680|NON_INFERIORITY|Site-stratified, 5% noninferiority test with a one-sided alpha at the 0.025 level.|Difference in proportions|0.9|||||TWO_SIDED|95.0|-2.5|4.5|||||The upper bound of a stratified Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting of the difference was used.|Malaise||4.5|-2.5|
72611976|NCT03183908|144752680|NON_INFERIORITY|Site-stratified, 5% noninferiority test with a one-sided alpha at the 0.025 level.|Difference in proportions|0.6|||||TWO_SIDED|95.0|-3.1|4.3|||||The upper bound of a stratified Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting of the difference was used.|Myalgia||4.3|-3.1|
72419033|NCT01490502|144348131|SUPERIORITY|||||||0.21|||||||Mixed Models Analysis|||Rate of change in quality of life was analyzed using a linear mixed effects model with unstructured covariance structure and random intercepts. The p-value is a test of whether there is a difference in the rate of change in health-related quality of life between treatment arms.||||0.21
72611977|NCT03183908|144752680|NON_INFERIORITY|Site-stratified, 5% noninferiority test with a one-sided alpha at the 0.025 level.|Difference in proportions|-1.0|||||TWO_SIDED|95.0|-3.3|1.3|||||The upper bound of a stratified Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting of the difference was used.|Nausea||1.3|-3.3|
72419034|NCT01490502|144348132|SUPERIORITY|||||||0.13|||||||Mixed Models Analysis|||||||0.13
72419035|NCT01490502|144348133|SUPERIORITY|||||||0.08|||||||Mixed Models Analysis|||||||0.08
72419036|NCT04493931|144348180|OTHER||Ratio of Geometric LS Mean|0.944|||||TWO_SIDED|90.0|0.753|1.184||||||||1.184|0.753|
72419037|NCT04493931|144348181|OTHER||Median Difference (Final Values)|-0.25|||||TWO_SIDED|90.0|-0.75|0.742|||||The median difference and the 90% CI of the median difference were from Hodges-Lehmann estimate.|||0.742|-0.750|
72419038|NCT04493931|144348182|OTHER||Ratio of Geometric LS Mean|1.094|||||TWO_SIDED|90.0|0.959|1.249||||||||1.249|0.959|
72419039|NCT04493931|144348183|OTHER||Ratio of Geometric LS Mean|1.157|||||TWO_SIDED|90.0|1.059|1.265||||||||1.265|1.059|
72419040|NCT04493931|144348184|OTHER||Ratio of Geometric LS Mean|1.158|||||TWO_SIDED|90.0|1.062|1.264||||||||1.264|1.062|
72419041|NCT04493931|144348185|OTHER||Ratio of Geometric LS Mean|0.73|||||TWO_SIDED|90.0|0.635|0.84||||||||0.840|0.635|
72419042|NCT04493931|144348186|OTHER||Median Difference (Final Values)|0.0|||||TWO_SIDED|90.0|0.0|0.0|||||The median difference and the 90% CI of the median difference were from Hodges-Lehmann estimate.|||0.000|0.000|
72419043|NCT04493931|144348187|OTHER||Median Difference (Final Values)|-0.467|||||TWO_SIDED|90.0|-1.0|0.492|||||The median difference and the 90% CI of the median difference were from Hodges-Lehmann estimate|||0.492|-1.000|
72419044|NCT04493931|144348188|OTHER||Ratio of Geometric LS Mean|0.476|||||TWO_SIDED|90.0|0.433|0.525||||||||0.525|0.433|
72419045|NCT04493931|144348189|OTHER||Ratio of Geometric LS Mean|0.478|||||TWO_SIDED|90.0|0.435|0.526||||||||0.526|0.435|
72419046|NCT04493931|144348190|OTHER||Ratio of Geometric LS mean|1.533|||||TWO_SIDED|90.0|1.274|1.845||||||||1.845|1.274|
72419047|NCT04493931|144348191|OTHER||Median Difference (Final Values)|0.0|||||TWO_SIDED|90.0|0.0|0.0|||||The median difference and the 90% CI of the median difference were from Hodges-Lehmann estimate.|||0.000|0.000|
72419048|NCT04493931|144348192|OTHER||Median Difference (Final Values)|-0.5|||||TWO_SIDED|90.0|-1.0|-0.233|||||The median difference and the 90% CI of the median difference were from Hodges-Lehmann estimate.|||-0.233|-1.000|
72419049|NCT04493931|144348193|OTHER||Ratio of Geometric LS mean|1.217|||||TWO_SIDED|90.0|1.085|1.363||||||||1.363|1.085|
72419050|NCT04493931|144348194|OTHER||Ratio of Geometric LS mean|1.121|||||TWO_SIDED|90.0|0.983|1.278||||||||1.278|0.983|
72419051|NCT04493931|144348195|OTHER||Ratio of Geometric LS mean|1.242|||||TWO_SIDED|90.0|1.046|1.475||||||||1.475|1.046|
72419052|NCT04493931|144348196|OTHER||Median Difference (Final Values)|0.0|||||TWO_SIDED|90.0|0.0|0.0|||||The median difference and the 90% CI of the median difference were from Hodges-Lehmann estimate.|||0.000|0.000|
72419053|NCT04493931|144348197|OTHER||Median Difference (Final Values)|0.0|||||TWO_SIDED|90.0|-0.25|0.8|||||The median difference and the 90% CI of the median difference were from Hodges-Lehmann estimate.|||0.800|-0.250|
72419054|NCT04493931|144348198|OTHER||Ratio of Geometric LS mean|1.923|||||TWO_SIDED|90.0|1.622|2.278||||||||2.278|1.622|
72419055|NCT04493931|144348199|OTHER||Ratio of Geometric LS mean|1.902|||||TWO_SIDED|90.0|1.619|2.234||||||||2.234|1.619|
72419056|NCT04493931|144348223|OTHER||Ratio of geometric LS mean|1.051|||||TWO_SIDED|90.0|0.824|1.34||||||||1.340|0.824|
72419057|NCT04493931|144348224|OTHER||Median Difference (Final Values)|0.0|||||TWO_SIDED|90.0|0.0|0.25|||||The median difference and the 90% CI of the median difference were from Hodges-Lehmann estimate.|||0.250|0.000|
72419058|NCT04493931|144348225|OTHER||Median Difference (Final Values)|0.5|||||TWO_SIDED|90.0|-0.5|1.25|||||The median difference and the 90% CI of the median difference were from Hodges-Lehmann estimate.|||1.250|-0.500|
72419059|NCT04493931|144348226|OTHER||Ratio of geometric LS mean|1.094|||||TWO_SIDED|90.0|0.987|1.212||||||||1.212|0.987|
72419060|NCT04493931|144348227|OTHER||Ratio of geometric LS mean|1.095|||||TWO_SIDED|90.0|0.991|1.209||||||||1.209|0.991|
72419061|NCT04493931|144348230|OTHER||Median Difference (Final Values)|0.0|||||TWO_SIDED|90.0|-0.25|0.0|||||The median difference and the 90% CI of the median difference were from Hodges-Lehmann estimate.|||0.000|-0.250|
72419062|NCT04493931|144348233|OTHER||Ratio of geometric LS mean|1.214|||||TWO_SIDED|90.0|1.0|1.473||||||||1.473|1.000|
72611978|NCT03183908|144752680|NON_INFERIORITY|Site-stratified, 5% noninferiority test with a one-sided alpha at the 0.025 level.|Difference in proportions|0.0|||||TWO_SIDED|95.0|-1.8|1.8|||||The upper bound of a stratified Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting of the difference was used.|Vomiting||1.8|-1.8|
72611979|NCT03183908|144752681|NON_INFERIORITY|Site-stratified, 5% noninferiority test with a one-sided alpha at the 0.025 level.|Difference in proportions|0.05|||||TWO_SIDED|95.0|-7.2|6.4|||||The upper bound of a stratified Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting of the difference was used.|Arthralgia||6.4|-7.2|
72419063|NCT04493931|144348234|OTHER||Ratio of geometric LS mean|1.097|||||TWO_SIDED|90.0|0.948|1.27||||||||1.270|0.948|
72419064|NCT04493931|144348235|OTHER||Ratio of geometric LS mean|1.071|||||TWO_SIDED|90.0|0.939|1.221||||||||1.221|0.939|
72419065|NCT04493931|144348236|OTHER||Ratio of geometric LS mean|1.096|||||TWO_SIDED|90.0|0.93|1.292||||||||1.292|0.930|
72419066|NCT04493931|144348250|OTHER||Ratio of geometric LS mean|0.499|||||TWO_SIDED|90.0|0.441|0.565||||||||0.565|0.441|
72419067|NCT04493931|144348251|OTHER||Ratio of geometric LS mean|0.439|||||TWO_SIDED|90.0|0.37|0.521||||||||0.521|0.370|
72419068|NCT04493931|144348252|OTHER||Ratio of geometric LS mean|0.438|||||TWO_SIDED|90.0|0.372|0.516||||||||0.516|0.372|
72419069|NCT04493931|144348253|OTHER||Ratio of geometric LS mean|1.036|||||TWO_SIDED|90.0|0.95|1.129||||||||1.129|0.950|
72611980|NCT03183908|144752681|NON_INFERIORITY|Site-stratified, 5% noninferiority test with a one-sided alpha at the 0.025 level.|Difference in proportions|-2.4|||||TWO_SIDED|95.0|-8.1|-0.6|||||The upper bound of a stratified Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting of the difference was used.|Diarrhea||-0.6|-8.1|
72611981|NCT03183908|144752681|NON_INFERIORITY|Site-stratified, 5% noninferiority test with a one-sided alpha at the 0.025 level.|Difference in proportions|3.7|||||TWO_SIDED|95.0|-3.6|10.9|||||The upper bound of a stratified Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting of the difference was used.|Fatigue||10.9|-3.6|
72419070|NCT04493931|144348277|OTHER||Ratio of Geometric LS mean|1.755|||||TWO_SIDED|90.0|1.304|2.363||||||||2.363|1.304|
72419071|NCT04493931|144348278|OTHER||Ratio of Geometric LS mean|0.833|||||TWO_SIDED|90.0|0.769|0.902||||||||0.902|0.769|
72419072|NCT04493931|144348279|OTHER||Ratio of Geometric LS mean|0.745|||||TWO_SIDED|90.0|0.653|0.85||||||||0.850|0.653|
72419073|NCT04493931|144348280|OTHER||Ratio of Geometric LS mean|0.892|||||TWO_SIDED|90.0|0.782|1.018||||||||1.018|0.782|
72419074|NCT04493931|144348281|OTHER||Ratio of Geometric LS mean|1.157|||||TWO_SIDED|90.0|0.876|1.528||||||||1.528|0.876|
72419075|NCT04493931|144348282|OTHER||Ratio of Geometric LS mean|1.142|||||TWO_SIDED|90.0|1.016|1.283||||||||1.283|1.016|
72419076|NCT04493931|144348283|OTHER||Ratio of Geometric LS mean|0.603|||||TWO_SIDED|90.0|0.521|0.699||||||||0.699|0.521|
72419077|NCT04493931|144348284|OTHER||Ratio of Geometric LS mean|0.526|||||TWO_SIDED|90.0|0.448|0.618||||||||0.618|0.448|
72419078|NCT01197508|144348328|SUPERIORITY_OR_OTHER||LS mean|1.1|STANDARD_ERROR_OF_MEAN|0.84||1|TWO_SIDED|95.0|-0.53|2.79||The adjusted p-value protects the overall family-wise error rate by taking into account the multiple comparisons between the TC-5214 doses for both the primary efficacy variable (MADRS) and the key secondary efficacy variable (SDS).|MMRM|||Mixed model repeated measures (MMRM) includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization MADRS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||2.79|-0.53|1.000
72419079|NCT01197508|144348328|SUPERIORITY_OR_OTHER||LS mean|0.5|STANDARD_ERROR_OF_MEAN|0.85||1|TWO_SIDED|95.0|-1.22|2.13|||MMRM|||Mixed model repeated measures (MMRM) includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization MADRS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||2.13|-1.22|1.000
72419080|NCT01197508|144348328|SUPERIORITY_OR_OTHER||LS mean|0.5|STANDARD_ERROR_OF_MEAN|0.88||1|TWO_SIDED|95.0|-1.21|2.22|||MMRM|||Mixed model repeated measures (MMRM) includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization MADRS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||2.22|-1.21|1.000
72419081|NCT01197508|144348329|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.71|STANDARD_ERROR_OF_MEAN|0.17||0.144|TWO_SIDED|95.0|0.45|1.12|||Regression, Logistic||TC-5214 is the numerator in the OR, OR\>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization MADRS total score as a covariate.||1.12|0.45|0.144
72419082|NCT01197508|144348329|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.74|STANDARD_ERROR_OF_MEAN|0.17||0.203|TWO_SIDED|95.0|0.47|1.17|||Regression, Logistic||TC-5214 is the numerator in the OR, OR\>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization MADRS total score as a covariate.||1.17|0.47|0.203
72419083|NCT01197508|144348329|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.52|STANDARD_ERROR_OF_MEAN|0.12||0.005|TWO_SIDED|95.0|0.32|0.82|||Regression, Logistic||TC-5214 is the numerator in the OR, OR\>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization MADRS total score as a covariate.||0.82|0.32|0.005
72419084|NCT01197508|144348330|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.89|STANDARD_ERROR_OF_MEAN|0.22||0.636|TWO_SIDED|95.0|0.54|1.45|||Regression, Logistic||TC-5214 is the numerator in the OR, OR\>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization MADRS total score as a covariate.||1.45|0.54|0.636
72419085|NCT01197508|144348330|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.73|STANDARD_ERROR_OF_MEAN|0.19||0.215|TWO_SIDED|95.0|0.44|1.2|||Regression, Logistic||TC-5214 is the numerator in the OR, OR\>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization MADRS total score as a covariate.||1.20|0.44|0.215
72419086|NCT01197508|144348330|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.58|STANDARD_ERROR_OF_MEAN|0.15||0.034|TWO_SIDED|95.0|0.35|0.96|||Regression, Logistic||TC-5214 is the numerator in the OR, OR\>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization MADRS total score as a covariate.||0.96|0.35|0.034
72419087|NCT01197508|144348331|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.85|STANDARD_ERROR_OF_MEAN|0.37||0.711|TWO_SIDED|95.0|0.36|1.99|||Regression, Logistic||TC-5214 is the numerator in the OR, OR\>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization MADRS total score as a covariate.||1.99|0.36|0.711
72419088|NCT01197508|144348331|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.79|STANDARD_ERROR_OF_MEAN|0.34||0.594|TWO_SIDED|95.0|0.34|1.85|||Regression, Logistic||TC-5214 is the numerator in the OR, OR\>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization MADRS total score as a covariate.||1.85|0.34|0.594
72419089|NCT01197508|144348331|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.15|STANDARD_ERROR_OF_MEAN|0.49||0.749|TWO_SIDED|95.0|0.5|2.65|||Regression, Logistic||TC-5214 is the numerator in the OR, OR\>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization MADRS total score as a covariate.||2.65|0.50|0.749
72611982|NCT03183908|144752681|NON_INFERIORITY|Site-stratified, 5% noninferiority test with a one-sided alpha at the 0.025 level.|Difference in proportions|1.2|||||TWO_SIDED|95.0|-2.4|6.6|||||The upper bound of a stratified Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting of the difference was used.|Fever||6.6|-2.4|
72419090|NCT01197508|144348332|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.52|STANDARD_ERROR_OF_MEAN|0.16||0.037|TWO_SIDED|95.0|0.28|0.96|||Regression, Logistic||TC-5214 is the numerator in the OR, OR\>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization MADRS total score as a covariate.||0.96|0.28|0.037
72419091|NCT01197508|144348332|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.69|STANDARD_ERROR_OF_MEAN|0.21||0.222|TWO_SIDED|95.0|0.38|1.25|||Regression, Logistic||TC-5214 is the numerator in the OR, OR\>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization MADRS total score as a covariate.||1.25|0.38|0.222
72419092|NCT01197508|144348332|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.52|STANDARD_ERROR_OF_MEAN|0.17||0.042|TWO_SIDED|95.0|0.28|0.98|||Regression, Logistic||TC-5214 is the numerator in the OR, OR\>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization MADRS total score as a covariate.||0.98|0.28|0.042
72611983|NCT03183908|144752681|NON_INFERIORITY|Site-stratified, 5% noninferiority test with a one-sided alpha at the 0.025 level.|Difference in proportions|5.0|||||TWO_SIDED|95.0|2.0|12.2|||||The upper bound of a stratified Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting of the difference was used.|Malaise||12.2|2.0|
72419093|NCT01197508|144348333|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.04|STANDARD_ERROR_OF_MEAN|0.41||0.913|TWO_SIDED|95.0|0.48|2.27|||Regression, Logistic||TC-5214 is the numerator in the OR, OR\>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization MADRS total score as a covariate.||2.27|0.48|0.913
72419094|NCT01197508|144348333|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.92|STANDARD_ERROR_OF_MEAN|0.37||0.841|TWO_SIDED|95.0|0.42|2.01|||Regression, Logistic||TC-5214 is the numerator in the OR, OR\>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization MADRS total score as a covariate.||2.01|0.42|0.841
72419095|NCT01197508|144348333|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.61|STANDARD_ERROR_OF_MEAN|0.26||0.239|TWO_SIDED|95.0|0.26|1.39|||Regression, Logistic||TC-5214 is the numerator in the OR, OR\>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization MADRS total score as a covariate.||1.39|0.26|0.239
72419096|NCT01197508|144348334|SUPERIORITY_OR_OTHER||LS mean|1.1|STANDARD_ERROR_OF_MEAN|0.705||0.12|TWO_SIDED|95.0|-0.288|2.481|||ANCOVA|||Analysis of covariance (ANCOVA) with randomization HAMD-17 total score as covariate, treatment as a fixed effect and pooled center as a random effect.||2.481|-0.288|0.120
72611984|NCT03183908|144752681|NON_INFERIORITY|Site-stratified, 5% noninferiority test with a one-sided alpha at the 0.025 level.|Difference in proportions|0.1|||||TWO_SIDED|95.0|-7.3|7.3|||||The upper bound of a stratified Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting of the difference was used.|Myalgia||7.3|-7.3|
72419097|NCT01197508|144348334|SUPERIORITY_OR_OTHER||LS mean|0.95|STANDARD_ERROR_OF_MEAN|0.715||0.184|TWO_SIDED|95.0|-0.452|2.354|||ANCOVA|||Analysis of covariance (ANCOVA) with randomization HAMD-17 total score as covariate, treatment as a fixed effect and pooled center as a random effect.||2.354|-0.452|0.184
72326661|NCT01118780|144176643|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The p-value is for percentage of participants having remission (HAMA Total Score ≤10) at Week 10 and was adjusted for pooled investigator.|Cochran-Mantel-Haenszel|||||||<0.001
72326662|NCT01118780|144176644|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The p-value is for the percentage of participants having functional remission (SDS Global Score ≤5) at Week 10 and was adjusted for pooled investigator.|Cochran-Mantel-Haenszel|||||||<0.001
72419098|NCT01197508|144348334|SUPERIORITY_OR_OTHER||LS mean|2.09|STANDARD_ERROR_OF_MEAN|0.711||0.003|TWO_SIDED|95.0|0.692|3.484|||ANCOVA|||Analysis of covariance (ANCOVA) with randomization HAMD-17 total score as covariate, treatment as a fixed effect and pooled center as a random effect.||3.484|0.692|0.003
72419099|NCT01197508|144348335|SUPERIORITY_OR_OTHER||LS mean|0.2|STANDARD_ERROR_OF_MEAN|0.12||0.131||95.0|-0.05|0.42|||MMRM|||MMRM model includes treatment, pooled center, visit, and treatment by visit interaction as explanatory variables and the randomization CGI-S total score as a covariate. Treatment, visit, and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||0.42|-0.05|0.131
72419100|NCT01197508|144348335|SUPERIORITY_OR_OTHER||LS mean|0.1|STANDARD_ERROR_OF_MEAN|0.12||0.551|TWO_SIDED|95.0|-0.17|0.31|||MMRM|||MMRM model includes treatment, pooled center, visit, and treatment by visit interaction as explanatory variables and the randomization CGI-S total score as a covariate. Treatment, visit, and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||0.31|-0.17|0.551
72419101|NCT01197508|144348335|SUPERIORITY_OR_OTHER||LS mean|0.1|STANDARD_ERROR_OF_MEAN|0.12||0.645|TWO_SIDED|95.0|-0.19|0.3|||MMRM|||MMRM model includes treatment, pooled center, visit, and treatment by visit interaction as explanatory variables and the randomization CGI-S total score as a covariate. Treatment, visit, and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||0.30|-0.19|0.645
72419102|NCT01197508|144348336|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.62|STANDARD_ERROR_OF_MEAN|0.15||0.046|TWO_SIDED|95.0|0.38|0.99|||Regression, Logistic||TC-5214 is the numerator in the OR, OR\>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization Clinical Global Impression Severity (CGI-S) as a covariate.||0.99|0.38|0.046
72419103|NCT01197508|144348336|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.62|STANDARD_ERROR_OF_MEAN|0.15||0.051|TWO_SIDED|95.0|0.38|1.0|||Regression, Logistic||TC-5214 is the numerator in the OR, OR\>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization Clinical Global Impression Severity (CGI-S) as a covariate.||1.00|0.38|0.051
72419104|NCT01197508|144348336|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.6|STANDARD_ERROR_OF_MEAN|0.15||0.04|TWO_SIDED|95.0|0.37|0.98|||Regression, Logistic||TC-5214 is the numerator in the OR, OR\>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization Clinical Global Impression Severity (CGI-S) as a covariate.||0.98|0.37|0.040
72611985|NCT03183908|144752682|SUPERIORITY|Non-parametric testing was used to evaluate the changes from baseline to compare between groups. A two-sided alpha level set at 0.01 with no adjustments set for multiple comparisons.||||||0.5862|||||||Wilcoxon (Mann-Whitney)|||Activity Limitation Changes for Day 1 to Day 3 Group Comparisons||||0.5862
72611986|NCT03183908|144752682|SUPERIORITY|Non-parametric testing was used to evaluate the changes from baseline to compare between groups. A two-sided alpha level set at 0.01 with no adjustments set for multiple comparisons.||||||0.5648|||||||Wilcoxon (Mann-Whitney)|||Daily Activities Changes for Day 1 to Day 3 Group Comparisons||||0.5648
72611987|NCT03183908|144752682|SUPERIORITY|Non-parametric testing was used to evaluate the changes from baseline to compare between groups. A two-sided alpha level set at 0.01 with no adjustments set for multiple comparisons.||||||0.4196|||||||Wilcoxon (Mann-Whitney)|||Basic Mobility Changes from Day 1 to Day 3 Group Comparisons||||0.4196
72611988|NCT03183908|144752682|SUPERIORITY|Non-parametric testing was used to evaluate the changes from baseline to compare between groups. A two-sided alpha level set at 0.01 with no adjustments set for multiple comparisons.||||||0.2418|||||||Wilcoxon (Mann-Whitney)|||Participation Restriction Changes from Day 1 to Day 3 Group Comparisons||||0.2418
72611989|NCT03183908|144752682|SUPERIORITY|Non-parametric testing was used to evaluate the changes from baseline to compare between groups. A two-sided alpha level set at 0.01 with no adjustments set for multiple comparisons.||||||0.0746|||||||Wilcoxon (Mann-Whitney)|||Social Roles Changes for Day 1 to Day 3 Group Comparisons||||0.0746
72326663|NCT01118780|144176644|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The p-value is for the percentage of participants having functional remission (SDS Global Score ≤6) at Week 10 and was adjusted for pooled investigator.|Cochran-Mantel-Haenszel|||||||<0.001
72326664|NCT01118780|144176645|SUPERIORITY_OR_OTHER|||||||0.001||95.0||||The p-value is for the percentage of participants having HAMA sustained improvement overall and was adjusted for pooled investigator.|Cochran-Mantel-Haenszel|||||||0.001
72419105|NCT01197508|144348337|SUPERIORITY_OR_OTHER||LS mean|0.7|STANDARD_ERROR_OF_MEAN|0.66||0.273|TWO_SIDED|95.0|-0.58|2.03|||ANCOVA|||An analysis of covariance (ANCOVA) with randomization HAM-A total score as covariate, treatment as a fixed effect and pooled center as a random effect.||2.03|-0.58|0.273
72419106|NCT01197508|144348337|SUPERIORITY_OR_OTHER||LS mean|0.7|STANDARD_ERROR_OF_MEAN|0.67||0.315|TWO_SIDED|95.0|-0.65|2.0|||ANCOVA|||An analysis of covariance (ANCOVA) with randomization HAM-A total score as covariate, treatment as a fixed effect and pooled center as a random effect.||2.00|-0.65|0.315
72419107|NCT01197508|144348337|SUPERIORITY_OR_OTHER||LS mean|1.2|STANDARD_ERROR_OF_MEAN|0.67||0.078|TWO_SIDED|95.0|-0.13|2.51|||ANCOVA|||An analysis of covariance (ANCOVA) with randomization HAM-A total score as covariate, treatment as a fixed effect and pooled center as a random effect.||2.51|-0.13|0.078
72419108|NCT01197508|144348338|SUPERIORITY_OR_OTHER||LS mean|0.3|STANDARD_ERROR_OF_MEAN|0.47||0.59|TWO_SIDED|95.0|-0.68|1.19|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization MADRS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||1.19|-0.68|0.590
72419109|NCT01197508|144348338|SUPERIORITY_OR_OTHER||LS mean|0.2|STANDARD_ERROR_OF_MEAN|0.48||0.679|TWO_SIDED|95.0|-0.74|1.14|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization MADRS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||1.14|-0.74|0.679
72611990|NCT03183908|144752682|SUPERIORITY|Non-parametric testing was used to evaluate the changes from baseline to compare between groups. A two-sided alpha level set at 0.01 with no adjustments set for multiple comparisons.||||||0.5497|||||||Wilcoxon (Mann-Whitney)|||Instrumental Roles Changes for Day 1 to Day 3 Group Comparisons||||0.5497
72611991|NCT03183908|144752683|SUPERIORITY|Non-parametric testing was used to evaluate the changes from baseline to compare between groups. A two-sided alpha level set at 0.05 with no adjustments set for multiple comparisons.||||||0.6278|||||||Wilcoxon (Mann-Whitney)|||Activity Limitation Changes for Day 1 to Day 3 Group Comparisons||||0.6278
72419110|NCT01197508|144348338|SUPERIORITY_OR_OTHER||LS mean|0.6|STANDARD_ERROR_OF_MEAN|0.48||0.215|TWO_SIDED|95.0|-0.35|1.53|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization MADRS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||1.53|-0.35|0.215
72419111|NCT01197508|144348339|SUPERIORITY_OR_OTHER||LS mean|1.2|STANDARD_ERROR_OF_MEAN|0.61||0.052|TWO_SIDED|95.0|-0.01|2.38|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization MADRS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||2.38|-0.01|0.052
72419112|NCT01197508|144348339|SUPERIORITY_OR_OTHER||LS mean|0.1|STANDARD_ERROR_OF_MEAN|0.61||0.874|TWO_SIDED|95.0|-1.11|1.3|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization MADRS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||1.30|-1.11|0.874
72419113|NCT01197508|144348339|SUPERIORITY_OR_OTHER||LS mean|1.0|STANDARD_ERROR_OF_MEAN|0.62||0.099|TWO_SIDED|95.0|-0.19|2.24|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization MADRS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||2.24|-0.19|0.099
72419114|NCT01197508|144348340|SUPERIORITY_OR_OTHER||LS mean|0.6|STANDARD_ERROR_OF_MEAN|0.69||0.394|TWO_SIDED|95.0|-0.77|1.95|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization MADRS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||1.95|-0.77|0.394
72419115|NCT01197508|144348340|SUPERIORITY_OR_OTHER||LS mean|0.3|STANDARD_ERROR_OF_MEAN|0.7||0.712|TWO_SIDED|95.0|-1.11|1.63|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization MADRS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||1.63|-1.11|0.712
72419116|NCT01197508|144348340|SUPERIORITY_OR_OTHER||LS mean|1.0|STANDARD_ERROR_OF_MEAN|0.71||0.167|TWO_SIDED|95.0|-0.41|2.38|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization MADRS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||2.38|-0.41|0.167
72419117|NCT01197508|144348341|SUPERIORITY_OR_OTHER||LS mean|1.5|STANDARD_ERROR_OF_MEAN|0.75||0.046|TWO_SIDED|95.0|0.02|2.95|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization MADRS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects the model; pooled center is a random effect.||2.95|0.02|0.046
72419118|NCT01197508|144348341|SUPERIORITY_OR_OTHER||LS mean|0.3|STANDARD_ERROR_OF_MEAN|0.75||0.681|TWO_SIDED|95.0|-1.17|1.79|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization MADRS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||1.79|-1.17|0.681
72419119|NCT01197508|144348341|SUPERIORITY_OR_OTHER||LS mean|1.3|STANDARD_ERROR_OF_MEAN|0.77||0.087|TWO_SIDED|95.0|-0.19|2.84|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization MADRS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||2.84|-0.19|0.087
72611992|NCT03183908|144752683|SUPERIORITY|Non-parametric testing was used to evaluate the changes from baseline to compare between groups. A two-sided alpha level set at 0.05 with no adjustments set for multiple comparisons.||||||0.5622|||||||Wilcoxon (Mann-Whitney)|||Daily Activities Changes for Day 1 to Day 3 Group Comparisons||||0.5622
72611993|NCT03183908|144752683|SUPERIORITY|Non-parametric testing was used to evaluate the changes from baseline to compare between groups. A two-sided alpha level set at 0.05 with no adjustments set for multiple comparisons.||||||0.5538|||||||Wilcoxon (Mann-Whitney)|||Basic Mobility Changes for Day 1 to Day 3 Group Comparisons||||0.5538
72611994|NCT03183908|144752683|SUPERIORITY|Non-parametric testing was used to evaluate the changes from baseline to compare between groups. A two-sided alpha level set at 0.05 with no adjustments set for multiple comparisons.||||||0.231|||||||Wilcoxon (Mann-Whitney)|||Participation Restriction Changes from Day 1 to Day 3 Group Comparisons||||0.2310
72611995|NCT03183908|144752683|SUPERIORITY|Non-parametric testing was used to evaluate the changes from baseline to compare between groups. A two-sided alpha level set at 0.05 with no adjustments set for multiple comparisons.||||||0.0435|||||||Wilcoxon (Mann-Whitney)|||Social Roles Changes from Day 1 to Day 3 Group Comparisons||||0.0435
72326665|NCT01118780|144176645|SUPERIORITY_OR_OTHER|||||||0.038||95.0||||The p-value is for the percentage of participants having HAMA sustained improvement from Week 2 and was adjusted for pooled investigator.|Cochran-Mantel-Haenszel|||||||0.038
72611996|NCT03183908|144752683|SUPERIORITY|Non-parametric testing was used to evaluate the changes from baseline to compare between groups. A two-sided alpha level set at 0.05 with no adjustments set for multiple comparisons.||||||0.6519|||||||Wilcoxon (Mann-Whitney)|||Instrumental Roles Changes from Day 1 to Day 3 Group Comparisons||||0.6519
72326666|NCT01118780|144176649|SUPERIORITY_OR_OTHER|||||||0.005||95.0||||The p-value was adjusted for pooled investigator.|Log Rank|||||||0.005
72419120|NCT01197508|144348342|SUPERIORITY_OR_OTHER||LS mean|0.98|STANDARD_ERROR_OF_MEAN|0.736||1|TWO_SIDED|95.0|-0.464|2.427||The adjusted p-value protects the overall family-wise error rate by taking into account the multiple comparisons between the TC-5214 doses for both the primary efficacy variable (MADRS) and the key secondary efficacy variable (SDS).|MMRM|||MMRM model includes treatment, pooled center, visit, and treatment by visit interaction as explanatory variables and the randomization SDS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||2.427|-0.464|1.000
72326667|NCT01118780|144176650|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The p-value is for the time to first remission (HAMA Total Score ≤10) and was adjusted for pooled investigator.|Log Rank|||||||<0.001
72326668|NCT01118780|144176651|SUPERIORITY_OR_OTHER|||||||0.001||95.0||||The p-value was adjusted for pooled investigator.|Log Rank|||||||0.001
72611997|NCT03183908|144752684|SUPERIORITY|Non-parametric testing was used to evaluate the changes from baseline to compare between groups. A two-sided alpha level set at 0.05 with no adjustments set for multiple comparisons.||||||0.7483|||||||Wilcoxon (Mann-Whitney)|||Activity Limitation Changes from Day 1 to Day 3 Group Comparisons||||0.7483
72611998|NCT03183908|144752684|SUPERIORITY|Non-parametric testing was used to evaluate the changes from baseline to compare between groups. A two-sided alpha level set at 0.05 with no adjustments set for multiple comparisons.||||||0.7483|||||||Wilcoxon (Mann-Whitney)|||Daily Activities Changes for Day 1 to Day 3 Group Comparisons||||0.7483
72611999|NCT03183908|144752684|SUPERIORITY|Non-parametric testing was used to evaluate the changes from baseline to compare between groups. A two-sided alpha level set at 0.05 with no adjustments set for multiple comparisons.||||||0.4953|||||||Wilcoxon (Mann-Whitney)|||Basic Mobility Changes for Day 1 to Day 3 Group Comparisons||||0.4953
72612000|NCT03183908|144752684|SUPERIORITY|Non-parametric testing was used to evaluate the changes from baseline to compare between groups. A two-sided alpha level set at 0.05 with no adjustments set for multiple comparisons.||||||0.8669|||||||Wilcoxon (Mann-Whitney)|||Participation Restriction Changes for Day 1 to Day 3 Group Comparisons||||0.8669
72612001|NCT03183908|144752684|SUPERIORITY|Non-parametric testing was used to evaluate the changes from baseline to compare between groups. A two-sided alpha level set at 0.05 with no adjustments set for multiple comparisons.||||||0.8451|||||||Wilcoxon (Mann-Whitney)|||Social Roles Changes for Day 1 to Day 3 Group Comparisons||||0.8451
72612002|NCT03183908|144752684|SUPERIORITY|Non-parametric testing was used to evaluate the changes from baseline to compare between groups. A two-sided alpha level set at 0.05 with no adjustments set for multiple comparisons.||||||0.7376|||||||Wilcoxon (Mann-Whitney)|||Instrumental Roles Changes for Day 1 to Day 3 Group Comparisons||||0.7376
72612003|NCT03183908|144752685|SUPERIORITY|Non-parametric testing was used to evaluate the changes from baseline to compare between groups. A two-sided alpha level set at 0.01 with no adjustments set for multiple comparisons.||||||0.7407|||||||Wilcoxon (Mann-Whitney)|||US Index Score Changes for Day 1 to Day 3 Group Comparisons||||0.7407
72612004|NCT03183908|144752686|SUPERIORITY|Non-parametric testing was used to evaluate the changes from baseline to compare between groups. A two-sided alpha level set at 0.05 with no adjustments set for multiple comparisons.||||||0.4032|||||||Wilcoxon (Mann-Whitney)|||US Index Score Changes for Day 1 to Day 3 Group Comparisons||||0.4032
72612005|NCT03183908|144752687|SUPERIORITY|Non-parametric testing was used to evaluate the changes from baseline to compare between groups. A two-sided alpha level set at 0.05 with no adjustments set for multiple comparisons.||||||0.4079|||||||Wilcoxon (Mann-Whitney)|||US Index Score Changes from Day 1 to Day 3 Group Comparisons||||0.4079
72612006|NCT03183908|144752688|SUPERIORITY|Non-parametric testing was used to evaluate the changes from baseline to compare between groups. A two-sided alpha level set at 0.01 with no adjustments set for multiple comparisons.||||||0.7948|||||||Wilcoxon (Mann-Whitney)|||EQ VAS Changes for Day 1 to Day 3 Group Comparisons||||0.7948
72612007|NCT03183908|144752689|SUPERIORITY|Non-parametric testing was used to evaluate the changes from baseline to compare between groups. Alpha level set at 0.05 with no adjustments set for multiple comparisons.||||||0.7953|||||||Wilcoxon (Mann-Whitney)|||EQ VAS Changes from Day 1 to Day 3 Group Comparisons||||0.7953
72612008|NCT03183908|144752690|SUPERIORITY|Non-parametric testing was used to evaluate the changes from baseline to compare between groups. A two-sided alpha level set at 0.05 with no adjustments set for multiple comparisons.||||||0.9329|||||||Wilcoxon (Mann-Whitney)|||EQ VAS Changes from Day 1 to Day 3 Group Comparisons||||0.9329
72612009|NCT02690727|144752782|SUPERIORITY_OR_OTHER||Ratio (%)|128.49||||0.0002|TWO_SIDED|90.0|119.13|138.59|||ANOVA|||||138.59|119.13|0.0002
72612010|NCT02690727|144752784|SUPERIORITY_OR_OTHER||Ratio (%)|139.27||||0.0278|TWO_SIDED|90.0|111.01|174.73|||ANOVA|||||174.73|111.01|0.0278
72612011|NCT02469857|144752836|SUPERIORITY|||||||0.135|||||||Chi-squared|||This analysis utilized the mITT analysis population.||||0.135
72612012|NCT02469857|144752836|SUPERIORITY|||||||0.025|||||||Chi-squared|||This analysis utilized the US-mITT analysis population.||||0.025
72612013|NCT02469857|144752840|SUPERIORITY|||||||0.069|||||||Chi-squared|||||||0.069
72612014|NCT02469857|144752841|SUPERIORITY|||||||0.401|||||||Wilcoxon (Mann-Whitney)|||||||0.401
72612015|NCT02469857|144752842|SUPERIORITY|||||||0.195|||||||Wilcoxon (Mann-Whitney)|||||||0.195
72612016|NCT02469857|144752843|SUPERIORITY|||||||0.596|||||||Wilcoxon (Mann-Whitney)|||||||0.596
72612017|NCT02469857|144752844|SUPERIORITY|||||||0.512|||||||Wilcoxon (Mann-Whitney)|||||||0.512
72612018|NCT02469857|144752845|SUPERIORITY|||||||0.033|||||||Chi-squared|||||||0.033
72612019|NCT02469857|144752846|SUPERIORITY||Hazard Ratio (HR)|0.85||||0.554|TWO_SIDED|95.0|0.5|1.46|||Log Rank|||||1.46|0.50|0.554
72612020|NCT02469857|144752847|SUPERIORITY||Hazard Ratio (HR)|0.54||||0.148|TWO_SIDED|95.0|0.23|1.26|||Log Rank|||||1.26|0.23|0.148
72612021|NCT02469857|144752848|SUPERIORITY||Hazard Ratio (HR)|0.89||||0.736|TWO_SIDED|95.0|0.46|1.73|||Log Rank|||||1.73|0.46|0.736
72612022|NCT02469857|144752849|SUPERIORITY||Hazard Ratio (HR)|0.34||||0.093|TWO_SIDED|95.0|0.09|1.25|||Log Rank|||||1.25|0.09|0.093
72612023|NCT02469857|144752850|SUPERIORITY||Hazard Ratio (HR)|0.71||||0.352|TWO_SIDED|95.0|0.35|1.46|||Log Rank|||||1.46|0.35|0.352
72612024|NCT02469857|144752851|SUPERIORITY||Hazard Ratio (HR)|0.21||||0.031|TWO_SIDED|95.0|0.04|0.99|||Log Rank|||||0.99|0.04|0.031
72612025|NCT02469857|144752852|SUPERIORITY|||||||0.024|||||||Chi-squared|||||||0.024
72612026|NCT02469857|144752853|SUPERIORITY|||||||0.007|||||||Chi-squared|||||||0.007
72612027|NCT02469857|144752854|SUPERIORITY|||||||0.034|||||||Chi-squared|||||||0.034
72612028|NCT02469857|144752855|SUPERIORITY|||||||0.003|||||||Chi-squared|||||||0.003
72612029|NCT02110693|144752856|OTHER|Concurrent validity of the interviewer and self-administered versions of the TAPS Tool compared to the reference standard was assessed for Alcohol Use Disorder using receiver operator characteristic (ROC) curves.|Sensitivity|0.7|||||TWO_SIDED|95.0|0.64|0.75||||||Each administration approach (interviewer and tablet) was tested separately against the reference measure.||.75|.64|
72419121|NCT01197508|144348342|SUPERIORITY_OR_OTHER||LS mean|0.72|STANDARD_ERROR_OF_MEAN|0.746||1|TWO_SIDED|95.0|-0.74|2.188||The adjusted p-value protects the overall family-wise error rate by taking into account the multiple comparisons between the TC-5214 doses for both the primary efficacy variable (MADRS) and the key secondary efficacy variable (SDS).|MMRM|||MMRM model includes treatment, pooled center, visit, and treatment by visit interaction as explanatory variables and the randomization SDS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||2.188|-0.740|1.000
72419122|NCT01197508|144348342|SUPERIORITY_OR_OTHER||LS mean|0.85|STANDARD_ERROR_OF_MEAN|0.762||1|TWO_SIDED|95.0|-0.649|2.346||The adjusted p-value protects the overall family-wise error rate by taking into account the multiple comparisons between the TC-5214 doses for both the primary efficacy variable (MADRS) and the key secondary efficacy variable (SDS).|MMRM|||MMRM model includes treatment, pooled center, visit, and treatment by visit interaction as explanatory variables and the randomization SDS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||2.346|-0.649|1.000
72419123|NCT01197508|144348343|SUPERIORITY_OR_OTHER||LS mean|0.0|STANDARD_ERROR_OF_MEAN|0.29||0.914|TWO_SIDED|95.0|-0.54|0.61|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization SDS work/school domain score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||0.61|-0.54|0.914
72419124|NCT01197508|144348343|SUPERIORITY_OR_OTHER||LS mean|0.2|STANDARD_ERROR_OF_MEAN|0.3||0.446|TWO_SIDED|95.0|-0.36|0.81|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization SDS work/school domain score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||0.81|-0.36|0.446
72419125|NCT01197508|144348343|SUPERIORITY_OR_OTHER||LS mean|0.1|STANDARD_ERROR_OF_MEAN|0.31||0.656|TWO_SIDED|95.0|-0.47|0.75|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization SDS work/school domain score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||0.75|-0.47|0.656
72419126|NCT01197508|144348344|SUPERIORITY_OR_OTHER||LS mean|0.3|STANDARD_ERROR_OF_MEAN|0.26||0.248|TWO_SIDED|95.0|-0.21|0.82|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization SDS social life domain score. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||0.82|-0.21|0.248
72419127|NCT01197508|144348344|SUPERIORITY_OR_OTHER||LS mean|0.2|STANDARD_ERROR_OF_MEAN|0.27||0.498|TWO_SIDED|95.0|-0.34|0.7|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization SDS social life domain score. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||0.70|-0.34|0.498
72612030|NCT02110693|144752856|OTHER|Concurrent validity of the interviewer and self-administered versions of the TAPS Tool compared to the reference standard was assessed for Alcohol Use Disorder using receiver operator characteristic (ROC) curves.|Sensitivity|0.74|||||TWO_SIDED|95.0|0.68|0.79||||||Each administration approach (interviewer and tablet) was tested separately against the reference measure.||.79|.68|
72612031|NCT02110693|144752857|OTHER|Concurrent validity of the interviewer and self-administered versions of the TAPS Tool compared to the reference standard was assessed for Cannabis Use Disorder using receiver operator characteristic (ROC) curves.|Sensitivity|0.71|||||TWO_SIDED|95.0|0.63|0.79||||||Each administration approach (interviewer and tablet) were separately tested against the reference measure.||.79|.63|
72419128|NCT01197508|144348344|SUPERIORITY_OR_OTHER||LS mean|0.2|STANDARD_ERROR_OF_MEAN|0.27||0.441|TWO_SIDED|95.0|-0.32|0.74|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization SDS social life domain score. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||0.74|-0.32|0.441
72419129|NCT01197508|144348345|SUPERIORITY_OR_OTHER||LS mean|0.4|STANDARD_ERROR_OF_MEAN|0.26||0.174|TWO_SIDED|95.0|-0.16|0.87|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization SDS family life/home responsibilities domain score. Treatment, visit and treatment by visit interaction are effects in the model; pooled center is a random effect.||0.87|-0.16|0.174
72419130|NCT01197508|144348345|SUPERIORITY_OR_OTHER||LS mean|0.2|STANDARD_ERROR_OF_MEAN|0.27||0.402|TWO_SIDED|95.0|-0.3|0.74|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization SDS family life/home responsibilities domain score. Treatment, visit and treatment by visit interaction are effects in the model; pooled center is a random effect.||0.74|-0.30|0.402
72612032|NCT02110693|144752857|OTHER|Concurrent validity of the interviewer and self-administered versions of the TAPS Tool compared to the reference standard was assessed for Cannabis Use Disorder using receiver operator characteristic (ROC) curves.|Sensitivity|0.7|||||TWO_SIDED|95.0|0.62|0.77||||||Each administration approach (interviewer and tablet) were separately tested against the reference measure.||.77|.62|
72612033|NCT02110693|144752858|OTHER|Concurrent validity of the interviewer and self-administered versions of the TAPS Tool compared to the reference standard was assessed for Cocaine and Amphetamine (Stimulant) Disorder using receiver operator characteristic (ROC) curves.|Sensitivity|0.57|||||TWO_SIDED|95.0|0.47|0.67||||||Each administration approach (interviewer and tablet) were tested separately against the reference measure.||.67|.47|
72419131|NCT01197508|144348345|SUPERIORITY_OR_OTHER||LS mean|0.3|STANDARD_ERROR_OF_MEAN|0.27||0.197|TWO_SIDED|95.0|-0.18|0.88|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization SDS family life/home responsibilities domain score. Treatment, visit and treatment by visit interaction are effects in the model; pooled center is a random effect.||0.88|-0.18|0.197
72419132|NCT01197508|144348346|SUPERIORITY_OR_OTHER||LS mean|-1.47|STANDARD_ERROR_OF_MEAN|1.643||0.371|TWO_SIDED|95.0|-4.697|1.756|||ANCOVA|||ANCOVA with randomization Q-LES-Q-SF % maximum total score as covariate, treatment as a fixed effect and pooled center as a random effect.||1.756|-4.697|0.371
72419133|NCT01197508|144348346|SUPERIORITY_OR_OTHER||LS mean|-1.32|STANDARD_ERROR_OF_MEAN|1.672||0.432|TWO_SIDED|95.0|-4.597|1.967|||ANCOVA|||ANCOVA with randomization Q-LES-Q-SF % maximum total score as covariate, treatment as a fixed effect and pooled center as a random effect.||1.967|-4.597|0.432
72419134|NCT01197508|144348346|SUPERIORITY_OR_OTHER||LS mean|-2.71|STANDARD_ERROR_OF_MEAN|1.672||0.105|TWO_SIDED|95.0|-5.992|0.573|||ANCOVA|||ANCOVA with randomization Q-LES-Q-SF % maximum total score as covariate, treatment as a fixed effect and pooled center as a random effect.||0.573|-5.992|0.105
72419135|NCT01197508|144348347|SUPERIORITY_OR_OTHER||LS mean|-0.1|STANDARD_ERROR_OF_MEAN|0.1||0.312|TWO_SIDED|95.0|-0.29|0.09|||ANCOVA|||An analysis of covariance (ANCOVA) with randomization Q-LES-Q-SF item 15 score as covariate, treatment as a fixed effect and pooled center as a random effect.||0.09|-0.29|0.312
72419136|NCT01197508|144348347|SUPERIORITY_OR_OTHER||LS mean|0.0|STANDARD_ERROR_OF_MEAN|0.1||0.885|TWO_SIDED|95.0|-0.18|0.21|||ANCOVA|||An analysis of covariance (ANCOVA) with randomization Q-LES-Q-SF item 15 score as covariate, treatment as a fixed effect and pooled center as a random effect.||0.21|-0.18|0.885
72419137|NCT01197508|144348347|SUPERIORITY_OR_OTHER||LS mean|-0.2|STANDARD_ERROR_OF_MEAN|0.1||0.067|TWO_SIDED|95.0|-0.37|0.01|||ANCOVA|||An analysis of covariance (ANCOVA) with randomization Q-LES-Q-SF item 15 score as covariate, treatment as a fixed effect and pooled center as a random effect.||0.01|-0.37|0.067
72419138|NCT01197508|144348348|SUPERIORITY_OR_OTHER||LS mean|-0.1|STANDARD_ERROR_OF_MEAN|0.1||0.152|TWO_SIDED|95.0|-0.33|0.05|||ANCOVA|||An analysis of covariance (ANCOVA) with randomization Q-LES-Q-SF item 16 as a fixed effect and pooled center as a random effect.||0.05|-0.33|0.152
72612034|NCT02110693|144752858|OTHER|Concurrent validity of the interviewer and self-administered versions of the TAPS Tool compared to the reference standard was assessed for Cocaine and Amphetamine (Stimulant) Use Disorder using receiver operator characteristic (ROC) curves.|Sensitivity|0.6|||||TWO_SIDED|95.0|0.5|0.69||||||Each administration approach (interviewer and tablet) were separately tested against the reference measure.||.69|.50|
72612035|NCT02110693|144752859|OTHER|Concurrent validity of the interviewer and self-administered versions of the TAPS Tool compared to the reference standard was assessed for Heroin Use Disorder using receiver operator characteristic (ROC) curves.|sensivity|0.66|||||TWO_SIDED|95.0|0.53|0.77||||||Each administration approach (interviewer and tablet) were tested separately against the reference measure.||.77|.53|
72612036|NCT02110693|144752859|OTHER|Concurrent validity of the interviewer and self-administered versions of the TAPS Tool compared to the reference standard was assessed for Heroin Use Disorder using receiver operator characteristic (ROC) curves.|Sensivity|0.66|||||TWO_SIDED|95.0|0.53|0.77||||||Each administration approach (interviewer and tablet) were tested separately against the reference measure.||.77|.53|
72419139|NCT01197508|144348348|SUPERIORITY_OR_OTHER||LS mean|-0.2|STANDARD_ERROR_OF_MEAN|0.1||0.078|TWO_SIDED|95.0|-0.37|0.02|||ANCOVA|||An analysis of covariance (ANCOVA) with randomization Q-LES-Q-SF item 16 as a fixed effect and pooled center as a random effect.||0.02|-0.37|0.078
72612037|NCT02110693|144752863|OTHER|The association on the interviewer and tablet computer administered versions of the TAPS Tool compared to the reference standard AUDIT-C score was assessed using Spearman Correlation.|Spearman Correlation|0.63|||||TWO_SIDED|95.0|0.59|0.66|||||The estimated value is a Spearman Correlation point estimate between TAPS Tool Alcohol Score and the AUDIT-C score. A Confidence Interval rather than a dispersion value is therefore reported.|Each administration approach (interviewer and tablet) were tested separately against the reference measure.||.66|.59|
72612038|NCT02110693|144752863|OTHER|The association on the interviewer and tablet administered versions of the TAPS Tool compared to the reference standard of the AUDIT C score was assessed using Spearman Correlation.|Spearman Correlation|0.64|||||TWO_SIDED|95.0|0.61|0.68|||||The estimated value is a Spearman Correlation point estimate between TAPS Tool Alcohol Score and the AUDIT-C Score. A Confidence Interval rather than a dispersion value is therefore reported.|Each administration approach (interviewer and tablet) was tested separately against the reference measure.||.68|.61|
72612039|NCT02110693|144752865|OTHER|The association on the interviewer and tablet computer administered versions of the TAPS Tool compared to the reference standard Smokeless Tobacco Questionnaire was assessed using Spearman Correlation.|Spearman Correlation|0.29|||||TWO_SIDED|95.0|0.25|0.33|||||The estimated value is a Spearman Correlation point estimate between the TAPS Tool Tobacco Score and the Smokeless Tobacco Questionnare. Confidence Interval rather than a dispersion value is therefore reported.|Each administration approach (interviewer and tablet computer) was tested separately against the reference measure.||.33|.25|
72419140|NCT01197508|144348348|SUPERIORITY_OR_OTHER||LS mean|-0.2|STANDARD_ERROR_OF_MEAN|0.1||0.033|TWO_SIDED|95.0|-0.41|-0.02|||ANCOVA|||An analysis of covariance (ANCOVA) with randomization Q-LES-Q-SF item 16 as a fixed effect and pooled center as a random effect.||-0.02|-0.41|0.033
72419141|NCT01197508|144348349|SUPERIORITY_OR_OTHER||LS mean|-0.011|STANDARD_ERROR_OF_MEAN|0.0181||0.543|TWO_SIDED|95.0|-0.0465|0.0245||Analysis for change in EQ-5D index score from randomization (Week 8) to end of treatment (Week 16)|MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization EQ-5D total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||0.0245|-0.0465|0.543
72419142|NCT01197508|144348349|SUPERIORITY_OR_OTHER||LS mean|0.0|STANDARD_ERROR_OF_MEAN|0.0183||0.998|TWO_SIDED|95.0|-0.036|0.0361||Analysis for change in EQ-5D index score from randomization (Week 8) to end of treatment (Week 16)|MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization EQ-5D total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||0.0361|-0.0360|0.998
72419143|NCT01197508|144348349|SUPERIORITY_OR_OTHER||LS mean|-0.006|STANDARD_ERROR_OF_MEAN|0.0188||0.743|TWO_SIDED|95.0|-0.0432|0.0308||Analysis for change in EQ-5D index score from randomization (Week 8) to end of treatment (Week 16)|MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization EQ-5D total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||0.0308|-0.0432|0.743
72419144|NCT01197508|144348349|SUPERIORITY_OR_OTHER||LS mean|-2.3|STANDARD_ERROR_OF_MEAN|1.95||0.244|TWO_SIDED|95.0|-6.1|1.56||Analysis of change in EQ-5D VAS score from randomization (Week 8) to end of treatment (Week 16)|MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization EQ-5D VAS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||1.56|-6.10|0.244
72419145|NCT01197508|144348349|SUPERIORITY_OR_OTHER||LS mean|-1.7|STANDARD_ERROR_OF_MEAN|1.98||0.389|TWO_SIDED|95.0|-5.59|2.18||Analysis of change in EQ-5D VAS score from randomization (Week 8) to end of treatment (Week 16)|MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization EQ-5D VAS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||2.18|-5.59|0.389
72419146|NCT01197508|144348349|SUPERIORITY_OR_OTHER||LS mean|-2.8|STANDARD_ERROR_OF_MEAN|2.02||0.165|TWO_SIDED|95.0|-6.79|1.16||Analysis of change in EQ-5D VAS score from randomization (Week 8) to end of treatment (Week 16)|MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization EQ-5D VAS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||1.16|-6.79|0.165
72419147|NCT01301391|144348367|SUPERIORITY||Single proportion|0.54|||<|0.001|TWO_SIDED|95.0|0.33|0.74||A priori threshold for statistical significance = 0.05|Fisher Exact|||H0:p≤ 25% vs H1:p\> 25% with an interesting PFS-3 rate of 50% (median PFS of 3 months), alpha=0.05 and beta=0.10, 30 evaluable patients are required for a single stage trial. If at the end of the trial 12 or more out of 30 evaluable patients are alive and progression-free at 3 months since the treatment start date, the null hypothesis are rejected. A Fleming multiple-testing procedure is applied. If \>=4 successes out of the first 15 patients are observed, accrual will continue up to 30.||0.74|0.33|<0.001
72419148|NCT02629991|144348378|SUPERIORITY|||||||0.059||||||Mixed effects model with random slopes and intercepts, including main effects for time and treatment group and a time by treatment interaction term.|Mixed effects model|||||||0.059
72419149|NCT02629991|144348379|SUPERIORITY|||||||0.088||||||Mixed effects model with random slopes and intercepts, including main effects for time and treatment group and a time by treatment interaction term.|Mixed effects model|||||||0.088
72612040|NCT02110693|144752865|OTHER||Spearman Correlation|0.28|||||TWO_SIDED|95.0|0.24|0.32|||||The estimated value is a Spearman Correlation point estimate between TAPS Tool Tobacco Score and the score on the Smokeless Tobacco Questionnaire. A Confidence Interval rather than a dispersion value is therefore reported.|Each administration approach (interviewer and tablet) were tested separately against the reference measure.||.32|.24|
72419150|NCT02629991|144348380|SUPERIORITY|||||||0.027|||||||Mixed effects model|Mixed effects model with random slopes and intercepts, including main effects for time and treatment group and a time by treatment interaction term.||||||0.027
72419151|NCT02629991|144348381|SUPERIORITY|Mixed effects model with random slopes and intercepts, including main effects for time and treatment group and a time by treatment interaction term.||||||0.16|||||||Mixed effects model|||||||0.16
72419152|NCT02629991|144348382|SUPERIORITY|||||||0.69|||||||Mixed effects model|Mixed effects model with random slopes and intercepts, including main effects for time and treatment group and a time by treatment interaction term.||||||0.69
72419153|NCT02629991|144348383|SUPERIORITY|||||||0.034||||||Mixed effects model with random slopes and intercepts, including main effects for time and treatment group and a time by treatment interaction term.|Mixed effects model|||||||0.034
72419154|NCT02629991|144348384|SUPERIORITY|||||||0.009|||||||Mixed effects model|Mixed effects model with random slopes and intercepts, including main effects for time and treatment group and a time by treatment interaction term.||||||0.009
72419155|NCT02629991|144348385|SUPERIORITY|||||||0.033|||||||Mixed effects model|Mixed effects model with random slopes and intercepts, including main effects for time and treatment group and a time by treatment interaction term.||||||0.033
72419156|NCT02629991|144348386|SUPERIORITY|||||||0.78|||||||Mixed effects model|Mixed effects model with random slopes and intercepts, including main effects for time and treatment group and a time by treatment interaction term.||||||0.78
72419157|NCT02629991|144348387|SUPERIORITY|||||||0.53|||||||Mixed effects model|Mixed effects model with random slopes and intercepts, including main effects for time and treatment group and a time by treatment interaction term.||||||0.53
72419158|NCT02799784|144348388|NON_INFERIORITY|If the lower bound of the two-sided 95% confidence interval around the (UMEC/VI 62.5/25 mcg versus TIO/OLO 5/5 mcg) treatment difference is above -50 milliliter then UMEC/VI 62.5/25 mcg was to be considered non-inferior to TIO/OLO 5/5 mcg.|Mean Difference (Final Values)|0.053|||<|0.001|TWO_SIDED|95.0|0.026|0.08|||Mixed Models Analysis|||||0.080|0.026|<0.001
72419159|NCT01624948|144348389|SUPERIORITY_OR_OTHER|||||||0.53|||||||Fisher Exact|||||||0.53
72419160|NCT01624948|144348391|SUPERIORITY_OR_OTHER|||||||0.67|||||||Wilcoxon (Mann-Whitney)|||Difference in p70S6 kinase phosphorylation as measured by mean fluorescence intensity (MFI) between those patients who reached the primary endpoint and those who did not||||0.67
72419161|NCT01624948|144348392|SUPERIORITY_OR_OTHER|||||||0.01|||||||Wilcoxon (Mann-Whitney)|||||||0.01
72419162|NCT01624948|144348394|SUPERIORITY_OR_OTHER|||||||0.49|||||||Wilcoxon (Mann-Whitney)|||||||0.49
72419163|NCT03466086|144348395|SUPERIORITY|This was a pilot study and the sample size was not based on any empirical power calculation.|Mean Difference (Final Values)|0.13|STANDARD_DEVIATION|1.238|||TWO_SIDED|95.0|-2.35|2.59||Superiority will be declared if the lower bound of the 2-sided 95% credible interval of the difference between Test and Control is greater than 0.|Multivariate Bayesian Model|The correlation between measurements across periods were modeled using unstructured variance-covariance matrix.|Mean Difference was calculated as Test minus Control.|||2.59|-2.35|
72419164|NCT03466086|144348396|SUPERIORITY|Superiority will be declared if the lower bound of the 2-sided 95% credible interval of the difference between Test and Control is less than 0.|Mean Difference (Final Values)|1.49|STANDARD_DEVIATION|0.951|||TWO_SIDED|95.0|-0.4|3.37|||Multivariate Bayesian Analysis|The correlation between measurements across periods were modeled using unstructured variance-covariance matrix.||This was a pilot study and the sample size was not based on any empirical power calculation.|Mean difference was calculated as Test - Control|3.37|-0.40|
72419165|NCT02570126|144348410|NON_INFERIORITY|Criterion for the Varilrix HSA-free vaccine as compared to Varilrix™ vaccine, the upper limit (UL) of the 2-sided standardised asymptotic 95% confidence interval (CI) for the group difference (VAR\_HSA\_F minus VAR) in incidence of fever \> 39.0°C (\> 102.2°F) within 0-14 days after Dose 1 was to be equal to or below 5%|Difference in percentage between groups|-1.29|||||TWO_SIDED|95.0|-3.72|1.08|||||Power obtained using PASS 2005 (Likelihood Score \[Miettinen and Nurminen approach\]), one-sided non-inferiority test for the difference of two independent proportions, under the alternative associated to the reference value \& alpha=2.5%|Non-inferiority of Varilrix HSA-free vaccine to Varilrix™ vaccine in terms of percentage of subjects reporting fever \> 39.0°C (\> 102.2°F) within 15-days (Days 0-14) after Dose 1 (VAR\_HSA\_F Group minus VAR Group)||1.08|-3.72|
72612041|NCT02110693|144752866|OTHER|The association on the interviewer and tablet computer administered versions of the TAPS Tool compared to the reference standard of the results of the oral fluid test was assessed using Spearman Correlation.|Spearman Correlation|0.42|||||TWO_SIDED|95.0|0.35|0.48|||||The estimated value is a Spearman Correlation point estimate between TAPS Tool Cannabis Score and the results of the Oral Fluid Test. Confidence Interval rather than a dispersion value is therefore reported.|Each administration approach (interviewer and tablet) were tested separately against the reference measure.||.48|.35|
72612042|NCT02110693|144752866|OTHER||Spearman Correlation|0.4|||||TWO_SIDED|95.0|0.33|0.46|||||The estimated value is a point estimate of the Spearman Correlation between the TAPS Tool Cannabis Score and the Oral Fluid Cannabis Screen. A Confidence Interval rather than a dispersion value is therefore reported.|||.46|.33|
72419166|NCT00917579|144348420|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the two treatments was concluded if the 90% confidence intervals for the ratio of adjusted geometric means for both AUCinf and Cmax fell within (80%, 125%).|ratio of adjusted geometric means|95.34||||||90.0|91.33|99.52|||ANOVA|Values were back-transformed from the log scale.|Parameter estimate = ratio (%) (test/reference) of adjusted geometric means. AUClast + (Clast\*/kel), where Clast\* was the predicted plasma concentration at the last quantifiable time point estimated from the log-linear regression analysis.|Natural log transformed AUCinf was analyzed using a mixed effects model with sequence, period and treatment as fixed effects and subject within sequence as a random effect. Adjusted mean difference (Test-Ref) and 90% CI was obtained from the model and exponentiated to provide estimates of the ratio of adjusted geometric mean and 90% CI for the ratio. Alternative hypothesis of bioequivalence: (H1: θL \<=µT - µR \<=θU); null hypothesis of inequivalence: (Ho: µT - µR \<θL or µT - µR \>θU).||99.52|91.33|
72419167|NCT00917579|144348421|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the two treatments was concluded if the 90% confidence intervals for the ratio of adjusted geometric means for both the AUCinf and Cmax fell within (80%, 125%). AUCinf method of determination includes AUC last calculated value.|ratio of adjusted geometric means|95.79||||||90.0|91.07|100.76|||ANOVA|Values have been back-transformed from the log scale.|Parameter estimate = ratio (%) (test/reference) of adjusted geometric means. Log-linear trapezoidal method.|Natural log transformed AUClast was analyzed using a mixed effects model with sequence, period and treatment as fixed effects and subject within sequence as a random effect. Estimates of the adjusted mean differences (Test-Reference) and corresponding 90% confidence interval was obtained from the model and exponentiated to provide estimates of the ratio of adjusted geometric mean (Test/Reference) and 90% confidence interval for the ratio.||100.76|91.07|
72419168|NCT00917579|144348422|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the two treatments was concluded if the 90% confidence intervals for the ratio of adjusted geometric means for both AUCinf and Cmax fell within (80%, 125%).|ratio of adjusted geometric means|91.41||||||90.0|83.39|100.2|||ANOVA|Values have been back-transformed from the log scale.|Parameter estimate = ratio (%) (test/reference) of adjusted geometric means.|Natural log transformed Cmax was analyzed using a mixed effects model with sequence, period and treatment as fixed effects and subject within sequence as a random effect. Estimates of the adjusted mean differences (Test-Reference) and corresponding 90% confidence intervals were obtained from the model and exponentiated to provide estimates of the ratio of adjusted geometric mean (Test/Reference) and 90% confidence interval for the ratio.||100.20|83.39|
72612043|NCT02763566|144752905|SUPERIORITY||Hazard Ratio (HR)|0.499||||0.0001|TWO_SIDED|95.0|0.346|0.719|||Log Rank|||||0.719|0.346|0.0001
72612044|NCT02763566|144752906|SUPERIORITY||Hazard Ratio (HR)|0.376|||<|0.0001|TWO_SIDED|95.0|0.24|0.588|||Log Rank|||||0.588|0.240|<0.0001
72612045|NCT02763566|144752908|SUPERIORITY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
72612046|NCT02763566|144752908|SUPERIORITY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
72612047|NCT02763566|144752910|SUPERIORITY|||||||0.0456|||||||Cochran-Mantel-Haenszel|||||||0.0456
72612048|NCT02763566|144752910|SUPERIORITY|||||||0.0004|||||||Cochran-Mantel-Haenszel|||||||0.0004
72612049|NCT02763566|144752911|SUPERIORITY|||||||0.0003|||||||Cochran-Mantel-Haenszel|||||||0.0003
72419169|NCT00677352|144348431|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Sertraline was concluded to be non-inferior to paroxetine when the upper limit of the CI fell below the non-inferiority margin of 4.|Mean Difference (Final Values)|-0.4|||||TWO_SIDED|95.0|-2.5|1.6|||ANCOVA|||The two-sided 95% confidence interval (CI) of the intergroup difference (sertraline group - paroxetine group) of the mean reduction in the PAS total score at each dose during the treatment phase was calculated using an analysis of covariance (ANCOVA) model with treatment group as a factor and baseline PAS total score as a covariate.||1.6|-2.5|
72419170|NCT00677352|144348437|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0062|TWO_SIDED|||||The p-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is 0.05 (two-sided).|Fisher Exact|||||||0.0062
72419171|NCT02182973|144348445|SUPERIORITY|||||||0.001|||||||t-test, 2 sided|||||||0.001
72419172|NCT02182973|144348446|SUPERIORITY|||||||0.875|||||||t-test, 2 sided|||||||0.875
72419173|NCT02182973|144348447|SUPERIORITY|||||||0.025|||||||t-test, 2 sided|||||||0.025
72419174|NCT01123382|144348467|SUPERIORITY_OR_OTHER|||||||0.04||||||Group X time interaction|Mixed Models Analysis|we included a random intercept for each individual participant. We used a first-order antedependent covariance structure.||To detect a minimum clinically important difference of 2 points2 on the BPI-SF3 with an anticipated standard deviation for each mean of 2.5, estimated from a prior study, with an alpha level of 0.05 and a power of 80%, for five waves of data, a sample size of 10 participants per group was necessary. With anticipated dropouts, a sample size of at least 12 participants per group was required.||||0.04
72612050|NCT02763566|144752911|SUPERIORITY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
72419175|NCT01123382|144348468|SUPERIORITY_OR_OTHER|||||||0.059|TWO_SIDED|||||group x time interaction 0.059|Mixed Models Analysis|||||||0.059
72419176|NCT01123382|144348469|SUPERIORITY_OR_OTHER|||||||0.543||||||group x time interaction 0.543|Mixed Models Analysis|||||||0.543
72419177|NCT01123382|144348470|SUPERIORITY_OR_OTHER|||||||0.33|TWO_SIDED|||||group x time interaction 0.33|Mixed Models Analysis|||||||0.33
72419178|NCT01123382|144348471|SUPERIORITY_OR_OTHER|||||||0.61|TWO_SIDED|||||group x time 0.61|Mixed Models Analysis|||||||0.61
72612051|NCT02763566|144752912|SUPERIORITY||LSMean Difference|-1.89|STANDARD_ERROR_OF_MEAN|1.77||0.287|TWO_SIDED|95.0|-5.36|1.59|||Mixed Models Analysis|||Global Health Status||1.59|-5.36|0.287
72612052|NCT02763566|144752912|SUPERIORITY||LSMean Difference|-0.77|STANDARD_ERROR_OF_MEAN|1.46||0.597|TWO_SIDED|95.0|-3.64|2.1|||Mixed Models Analysis|||Functional Scales - Physical functioning||2.10|-3.64|0.597
72419179|NCT01123382|144348472|SUPERIORITY_OR_OTHER|||||||0.398||||||group x time interaction 0.398|Mixed Models Analysis|||||||0.398
72612053|NCT02763566|144752912|SUPERIORITY||LSMean Difference|-0.31|STANDARD_ERROR_OF_MEAN|2.15||0.885|TWO_SIDED|95.0|-4.55|3.93|||Mixed Models Analysis|||Functional Scales - Role Functioning||3.93|-4.55|0.885
72612054|NCT02763566|144752912|SUPERIORITY||LSMean Difference|1.67|STANDARD_ERROR_OF_MEAN|1.74||0.34|TWO_SIDED|95.0|-1.77|5.1|||Mixed Models Analysis|||Functional Scales - Emotional Functioning||5.10|-1.77|0.340
72419180|NCT01123382|144348473|SUPERIORITY_OR_OTHER|||||||0.46||||||group x time interaction 0.46|Mixed Models Analysis|||||||0.46
72419181|NCT01123382|144348474|SUPERIORITY_OR_OTHER|||||||0.59||||||group x time interaction 0.59|Mixed Models Analysis|||||||0.59
72419182|NCT01123382|144348475|SUPERIORITY_OR_OTHER|||||||0.69||||||group x time interaction 0.69|Mixed Models Analysis|||||||0.69
72419183|NCT02740049|144348481|SUPERIORITY|||||||0.0002||||||P value is the comparison between the IFN/TNF induction group versus the VR588 (10-7M) treatment group.|Wilcoxon (Mann-Whitney)|||Statistical differences is determined using the Kruskal-Wallis test followed by Dunn's multiple comparison test or a Wilcoxon signed rank test as appropriate.||||0.0002
72419184|NCT02740049|144348482|SUPERIORITY|||||||0.3994||||||P value is the comparison between the IFN/TNF induction group versus the VR588 (10-7M) treatment group|Wilcoxon (Mann-Whitney)|||Statistical differences is determined using the Kruskal-Wallis test followed by Dunn's multiple comparison test or Wilcoxon signed rank test as appropriate.||||0.3994
72419185|NCT02740049|144348483|SUPERIORITY|||||||0.0104||||||P value is the comparison between the IFN/TNF induction group versus VR588 (10-7M) treatment group.|Wilcoxon (Mann-Whitney)|||Statistical difference is determined using the Kruskal-Wallis test followed by Dunn's multiple comparison test or a Wilcoxon signed rank test as appropriate.||||0.0104
72419186|NCT05120115|144348489|EQUIVALENCE|Examined differences between conditions||||||0.05||||||Used Tukey Honestly Significant Difference post-hoc test|ANOVA|||||||0.05
72419187|NCT05120115|144348490|EQUIVALENCE|Differences between conditions||||||0.05||||||Used Tukey Honestly Significant Difference post-hoc test|Mixed Models Analysis|||||||0.05
72612055|NCT02763566|144752912|SUPERIORITY||LSMean Difference|-2.17|STANDARD_ERROR_OF_MEAN|1.62||0.182|TWO_SIDED|95.0|-5.37|1.03|||Mixed Models Analysis|||Functional Scales - Cognitive Functioning||1.03|-5.37|0.182
72612056|NCT02763566|144752912|SUPERIORITY||LSMean Difference|-0.88|STANDARD_ERROR_OF_MEAN|2.12||0.678|TWO_SIDED|95.0|-5.05|3.29|||Mixed Models Analysis|||||3.29|-5.05|0.678
72612057|NCT02763566|144752912|SUPERIORITY||LSMean Difference|1.57|STANDARD_ERROR_OF_MEAN|1.7||0.355|TWO_SIDED|95.0|-1.77|4.91|||Mixed Models Analysis|||Symptom Scales - Fatigue||4.91|-1.77|0.355
72612058|NCT02763566|144752912|SUPERIORITY||LSMean Difference|0.95|STANDARD_ERROR_OF_MEAN|1.06||0.372|TWO_SIDED|95.0|-1.14|3.03|||Mixed Models Analysis|||Symptom Scales - Nausea and Vomiting||3.03|-1.14|0.372
72612059|NCT02763566|144752912|SUPERIORITY||LSMean Difference|0.74|STANDARD_ERROR_OF_MEAN|1.63||0.74|TWO_SIDED|95.0|-3.75|2.66|||Mixed Models Analysis|||Symptom Scales - Pain||2.66|-3.75|0.740
72419188|NCT05120115|144348491|EQUIVALENCE|Differences between conditions||||||0.05||||||Used Tukey Honestly Significant Difference post-hoc test|Mixed Models Analysis|||||||0.05
72419189|NCT02684006|144348545|SUPERIORITY||Hazard Ratio (HR)|0.61||||0.0001|TWO_SIDED|95.0|0.475|0.79||2-sided p-value|Log Rank|||||0.790|0.475|0.0001
72419190|NCT02684006|144348546|SUPERIORITY||Hazard Ratio (HR)|0.86||||0.1509|TWO_SIDED|95.0|0.701|1.057||2-sided p-value|Log Rank|||||1.057|0.701|0.1509
72419191|NCT02684006|144348547|SUPERIORITY||Hazard Ratio (HR)|0.69||||0.0002|TWO_SIDED|95.0|0.563|0.84||2-sided p-value|Log Rank|||||0.840|0.563|0.0002
72419192|NCT02684006|144348548|SUPERIORITY||Hazard Ratio (HR)|0.88||||0.1338|TWO_SIDED|95.0|0.749|1.039||2-sided p-value|Log Rank|||||1.039|0.749|0.1338
72419193|NCT02684006|144348557|SUPERIORITY||Hazard Ratio (HR)|0.66|||<|0.0001|TWO_SIDED|95.0|0.565|0.768||2-sided p-value|Log Rank|||||0.768|0.565|<.0001
72419194|NCT02684006|144348558|SUPERIORITY||Hazard Ratio (HR)|0.64|||||TWO_SIDED|95.0|0.551|0.754||||||||0.754|0.551|
72419195|NCT00715429|144348618|SUPERIORITY_OR_OTHER_LEGACY|||||||0.27||||||Daily cramp rate at baseline\& on treatment, were calculated as % of each subjects total # of cramps, for comparison among subjects. Change in % cramp rates from baseline to treatment was computed for each subject in vit D and placebo groups.|t-test, 2 sided|T test was used to compare the change in % cramp rate from baseline to treatment for each subject in each treatment group.||||||0.27
72419196|NCT04085328|144348622|NON_INFERIORITY|Predefined margin of 0.05 for noninferiority|Difference in proportion|-0.0154|||||ONE_SIDED|95.0||-0.0015|||Generalized linear model|Proportion of events was analyzed using a generalized linear model, with a logit link function, accounting for within-subject correlation.|Difference in proportion = LID015385 minus Biofinity.|||-0.0015||
72419197|NCT05417620|144348623|OTHER||Incidence rate ratio|1.21||||0.707|TWO_SIDED|95.0|0.44|3.31||Threshold for significance: 0.05.|Regression, Poisson|||"This statistical analysis is done at the district level where counts of initiations in intervention districts are compared to standard of care districts. In the measure type we report rate = average counts of PrEP initiations per number of study months."||3.31|0.44|0.707
72419198|NCT02413580|144348634|OTHER|The hypothesis test is to test the null hypothesis: H0: μd = 0 versus alternative hypothesis Ha: μd ≠ 0 where μd is the mean change from Baseline to Day 14. The Shapiro-Wilk test is used to test the normality. If the assumptions for parametric test are met, a paired t-test (comparison between the pre- and post-treatment) is used to test for the treatment effect. Otherwise, a non-parametric test (Wilcoxon signed rank test) is used.|Mean Difference (Final Values)|-6.4|||<|0.001|TWO_SIDED|95.0|-7.957|-4.787|||Paired t-test|||||-4.787|-7.957|<0.001
72419199|NCT04274894|144348680|NON_INFERIORITY|"The hypothesis for the primary safety analysis is:~H0: Change in 24-hour average SBP from Baseline to EOT ≥ 3 mmHg Vs. H1: Change in 24-hour average SBP from Baseline to EOT \< 3 mmHg"|LS Mean Change from Baseline to EOT|1.9|STANDARD_ERROR_OF_MEAN|0.63|||TWO_SIDED|95.0|0.63|3.13||||||The primary endpoint of change from Baseline to End of Treatment (EOT) in average 24-hour SBP was evaluated using a linear regression model with change in average 24-hour SBP from Baseline to EOT as the dependent variable, centralized baseline average 24-hour SBP, ongoing medical history of hypertension, and pooled study center as covariates in the per protocol population.||3.13|0.63|
72419200|NCT02279043|144348686|SUPERIORITY||Odds Ratio (OR)|0.88||||0.89|TWO_SIDED|95.0|0.16|4.88|||Regression, Logistic|||||4.88|0.16|0.89
72419201|NCT02279043|144348687|SUPERIORITY|||||||0.28|||||||t-test, 2 sided|||||||0.28
72419202|NCT02279043|144348688|SUPERIORITY|||||||0.03|||||||t-test, 2 sided|||||||0.03
72419203|NCT02279043|144348688|SUPERIORITY||Slope|0.59||||0.02|TWO_SIDED|95.0|0.08|1.11|||Regression, Linear|||Multivariate analysis adjusting for cluster, as association was significant in bivariate test.||1.11|0.08|0.02
72419204|NCT02279043|144348689|SUPERIORITY|||||||0.59|||||||t-test, 2 sided|||||||0.59
72326669|NCT01118780|144176652|SUPERIORITY_OR_OTHER|||||||0.006||95.0||||The p-value is for the time to first functional remission (SDS Global Functional Impairment Score ≤5) and was adjusted for pooled investigator.|Log Rank|||||||0.006
72419205|NCT02279043|144348690|SUPERIORITY|||||||0.08|||||||t-test, 2 sided|||||||0.08
72419206|NCT02279043|144348691|SUPERIORITY||Odds Ratio (OR)|1.29||||0.34|TWO_SIDED|95.0|0.75|2.2|||Regression, Logistic|||||2.20|0.75|0.34
72419207|NCT02279043|144348692|SUPERIORITY||Odds Ratio (OR)|1.0||||0.99|TWO_SIDED|95.0|0.49|2.05|||Regression, Logistic|||||2.05|0.49|0.99
72419208|NCT02279043|144348693|SUPERIORITY||Odds Ratio (OR)|1.48||||0.08|TWO_SIDED|95.0|0.95|2.29|||Regression, Logistic|||||2.29|0.95|0.08
72419209|NCT02279043|144348694|SUPERIORITY||Odds Ratio (OR)|1.63||||0.03|TWO_SIDED|95.0|1.05|2.58|||Regression, Logistic|||||2.58|1.05|0.03
72419210|NCT02279043|144348694|SUPERIORITY||Slope|0.5||||0.03|TWO_SIDED|95.0|0.04|0.97|||Mixed Models Analysis|Mixed effects logistic regression||Multivariate analysis adjusting for cluster, as association was significant in bivariate test.||0.97|0.04|0.03
72419211|NCT02279043|144348695|SUPERIORITY||Odds Ratio (OR)|2.25|||<|0.01|TWO_SIDED|95.0|1.42|3.56|||Regression, Logistic|||||3.56|1.42|<0.01
72419212|NCT02279043|144348695|SUPERIORITY||Slope|0.84|||<|0.01|TWO_SIDED|95.0|0.33|1.35|||Mixed Models Analysis|Mixed effects logistic regression||Multivariate analysis adjusting for cluster, as association was significant in bivariate test.||1.35|0.33|<0.01
72419213|NCT02279043|144348696|SUPERIORITY||Odds Ratio (OR)|1.02||||0.93|TWO_SIDED|95.0|0.52|2.74|||Regression, Logistic|||||2.74|0.52|0.93
72419214|NCT02279043|144348697|SUPERIORITY||Odds Ratio (OR)|1.19||||0.68|TWO_SIDED|95.0|0.52|2.74|||Regression, Logistic|||||2.74|0.52|0.68
72419215|NCT02279043|144348698|SUPERIORITY||Odds Ratio (OR)|1.24||||0.33|TWO_SIDED|95.0|0.08|1.93|||Regression, Logistic|||||1.93|0.08|0.33
72419216|NCT01499082|144348736|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|"Stepwise closed testing approach was used to assess non-inferiority and superiority sequentially:~1. Non-inferiority of HOE901-U300 vs Lantus: Upper bound of two-sided 95% confidence interval (CI) of difference between HOE901-U300 and Lantus on mITT population is \<0.4%.~2. Superiority (only if non-inferiority has been demonstrated): Upper bound of two-sided 95% CI for difference in mean change in HbA1c from baseline to endpoint between HOE901-U300 and Lantus on mITT population is \<0."|Least Squares (LS) Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.056|||TWO_SIDED|95.0|-0.112|0.107||||||Analysis was performed using an analysis of covariance (ANCOVA) model with treatment, strata of screening HbA1c (\<8.0 and \>=8.0%), and country as fixed effects and using the HbA1c baseline value as a covariate.||0.107|-0.112|
72612060|NCT02763566|144752912|SUPERIORITY||LSMean Difference|2.16|STANDARD_ERROR_OF_MEAN|1.84||0.24|TWO_SIDED|95.0|-1.46|5.78|||Mixed Models Analysis|||Symptom Scales - Dyspnoea||5.78|-1.46|0.240
72612061|NCT02763566|144752912|SUPERIORITY||LSMean Difference|-0.81|STANDARD_ERROR_OF_MEAN|1.92||0.673|TWO_SIDED|95.0|-4.6|2.97|||Mixed Models Analysis|||Symptom scales - Insomnia||2.97|-4.60|0.673
72612062|NCT02763566|144752912|SUPERIORITY||LSMean Difference|5.65|STANDARD_ERROR_OF_MEAN|1.74||0.001|TWO_SIDED|95.0|2.23|9.07|||Mixed Models Analysis|||Symptom Scales - Appetite||9.07|2.23|0.001
72612063|NCT02763566|144752912|SUPERIORITY||LSMean Difference|-1.57|STANDARD_ERROR_OF_MEAN|1.76||0.375|TWO_SIDED|95.0|-5.04|1.91|||Mixed Models Analysis|||Symptom Scales - Constipation||1.91|-5.04|0.375
72612064|NCT02763566|144752912|SUPERIORITY||LSMean Difference|15.82|STANDARD_ERROR_OF_MEAN|1.53||0|TWO_SIDED|95.0|12.81|18.84|||Mixed Models Analysis|||Symptom Scales - Diarrhoea||18.84|12.81|0.000
72612065|NCT02763566|144752912|SUPERIORITY||LSMean Difference|-1.75|STANDARD_ERROR_OF_MEAN|2.97||0.557|TWO_SIDED|95.0|-7.59|4.1|||Mixed Models Analysis|||Symptom Scales - Financial Difficulties||4.10|-7.59|0.557
72612066|NCT02763566|144752912|SUPERIORITY||LSMean Difference|-3.47|STANDARD_ERROR_OF_MEAN|2.51||0.169|TWO_SIDED|95.0|-8.43|1.49|||Mixed Models Analysis|||Global Health Status||1.49|-8.43|0.169
72612067|NCT02763566|144752912|SUPERIORITY||LSMean Difference|1.58|STANDARD_ERROR_OF_MEAN|1.87||0.4|TWO_SIDED|95.0|-2.12|5.29|||Mixed Models Analysis|||Functional Scales - Physical Functioning||5.29|-2.12|0.400
72612068|NCT02763566|144752912|SUPERIORITY||LSMean Difference|-1.72|STANDARD_ERROR_OF_MEAN|2.38||0.472|TWO_SIDED|95.0|-6.42|2.99|||Mixed Models Analysis|||Functional Scales - Role functioning||2.99|-6.42|0.472
72612069|NCT02763566|144752912|SUPERIORITY||LSMean Difference|-2.42|STANDARD_ERROR_OF_MEAN|0.31||0.31|TWO_SIDED|95.0|-7.12|2.28|||Mixed Models Analysis|||Functional Scales - Emotional Functioning||2.28|-7.12|0.310
72612070|NCT02763566|144752912|SUPERIORITY||LSMean Difference|0.64|STANDARD_ERROR_OF_MEAN|2.98||0.83|TWO_SIDED|95.0|-5.26|6.55|||Mixed Models Analysis|||Functional Scales - Social Functioning||6.55|-5.26|0.830
72612071|NCT02763566|144752912|SUPERIORITY||LSMean Difference|2.73|STANDARD_ERROR_OF_MEAN|2.52||0.281|TWO_SIDED|95.0|-2.26|7.72|||Mixed Models Analysis|||Symptom Scales - Fatigue||7.72|-2.26|0.281
72612072|NCT02763566|144752912|SUPERIORITY||LSMean Difference|2.59|STANDARD_ERROR_OF_MEAN|1.99||0.194|TWO_SIDED|95.0|-1.33|6.52|||Mixed Models Analysis|||Symptom Scales - Nausea and Vomiting||6.52|-1.33|0.194
72326670|NCT01118780|144176652|SUPERIORITY_OR_OTHER|||||||0.003||95.0||||The p-value is for time to first functional remission (SDS Global Functional Impairment Score ≤6) and was adjusted for pooled investigator.|Log Rank|||||||0.003
72326671|NCT01118780|144176653|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The p-value was adjusted for pooled investigator.|Log Rank|||||||<0.001
72612073|NCT02763566|144752912|SUPERIORITY||LSMean Difference|-2.66|STANDARD_ERROR_OF_MEAN|2.42||0.275|TWO_SIDED|95.0|-7.45|2.14|||Mixed Models Analysis|||Symptom Scales - Pain||2.14|-7.45|0.275
72612074|NCT02763566|144752912|SUPERIORITY||LSMean Difference|-2.49|STANDARD_ERROR_OF_MEAN|4.39||0.28|TWO_SIDED|95.0|-7.04|2.06|||Mixed Models Analysis|||Symptom Scales - Dyspnoea||2.06|-7.04|0.280
72612075|NCT02763566|144752912|SUPERIORITY||LSMean Difference|1.97|STANDARD_ERROR_OF_MEAN|2.9||0.499|TWO_SIDED|95.0|-3.78|7.72|||Mixed Models Analysis|||Symptom Scales - Insomnia||7.72|-3.78|0.499
72612076|NCT02763566|144752912|SUPERIORITY||LSMean Difference|7.46|STANDARD_ERROR_OF_MEAN|2.92||0.012|TWO_SIDED|95.0|1.68|13.23|||Mixed Models Analysis|||Symptom Scales - Appetite||13.23|1.68|0.012
72612077|NCT02763566|144752912|SUPERIORITY||LSMean Difference|-2.28|STANDARD_ERROR_OF_MEAN|2.29||0.321|TWO_SIDED|95.0|-6.83|2.27|||Mixed Models Analysis|||Symptom Scales - Constipation||2.27|-6.83|0.321
72612078|NCT02763566|144752912|SUPERIORITY||LSMean Difference|17.83|STANDARD_ERROR_OF_MEAN|2.32||0|TWO_SIDED|95.0|13.25|22.41|||Mixed Models Analysis|||Symptom Scales - Diarrhoea||22.41|13.25|0.000
72612079|NCT02763566|144752912|SUPERIORITY||LSMean Difference|2.99|STANDARD_ERROR_OF_MEAN|3.14||0.342|TWO_SIDED|95.0|-3.21|9.19|||Mixed Models Analysis|||Symptom Scales - Financial DIfficulties||9.19|-3.21|0.342
72612080|NCT02763566|144752912|SUPERIORITY||LSMean Difference|-2.42|STANDARD_ERROR_OF_MEAN|2.38||0.31|TWO_SIDED|95.0|-7.12|2.28|||Mixed Models Analysis|||Functional Scales - Cognitive functioning||2.28|-7.12|0.310
72612081|NCT00914069|144752920|SUPERIORITY_OR_OTHER|||||||0.05||||||Threshold for significance was p less than or equal to 0.05 by a one-tailed Fisher Exact Test.|Fisher Exact|||||||0.05
72612082|NCT00914069|144752923|SUPERIORITY_OR_OTHER|||||||0.8|||||||Fisher Exact|||||||0.8
72612083|NCT01933594|144752927|SUPERIORITY|||||||0.88|||||||Wilcoxon (Mann-Whitney)|||||||0.88
72612084|NCT01933594|144752928|SUPERIORITY|||||||0.94|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 24 hours post infusion 1||||0.94
72612085|NCT01933594|144752928|SUPERIORITY|||||||0.74|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 24 hours post infusion 2||||0.74
72612086|NCT01933594|144752928|SUPERIORITY|||||||0.18|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 24 hours post infusion 3||||0.18
72419217|NCT01499082|144348737|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.79||||0.0045|TWO_SIDED|95.0|0.67|0.93|||Cochran-Mantel-Haenszel|||A one-sided test (at alpha=0.025) for superiority of HOE901-U300 over Lantus was to be performed in case the non-inferiority of HOE901-U300 vs Lantus for the primary endpoint was demonstrated. Analysis was performed using Cochran-Mantel-Haenszel (CMH) method with treatment as a factor and stratified on strata of screening HbA1c (\<8.0 and \>=8.0%).||0.93|0.67|0.0045
72419218|NCT01499082|144348738|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.162||0.6909|TWO_SIDED|95.0|-0.383|0.254|||ANCOVA|||Change in pre-injection SMPG was analyzed using an ANCOVA model with treatment, strata of screening HbA1c (\<8.0 and \>=8.0%), and country as fixed effects and using the pre-injection SMPG baseline value as a covariate. A test for superiority of HOE901-U300 over Lantus was to be performed one-sided at level alpha = 0.025 if previous analysis for nocturnal hypoglycemia was significant.||0.254|-0.383|0.6909
72419219|NCT01499082|144348747|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.05|STANDARD_ERROR_OF_MEAN|0.123|||TWO_SIDED|95.0|-0.189|0.298||||||Analysis was performed using Analysis of covariance (ANCOVA) model with treatment regimen and country as fixed effects and baseline HbA1c value as a covariate.||0.298|-0.189|
72419220|NCT04557930|144348757|SUPERIORITY||Odds Ratio (OR)|0.96||||0.41|TWO_SIDED|95.0|0.88|1.06|||Mixed Models Analysis|||We tested the association between exposure to the intervention and the incidence of ACP billing in the pre- and post-intervention periods using a mixed effects logistic regression model, adjusting for time, patient and hospital covariates.||1.06|0.88|0.41
72419221|NCT04557930|144348757|SUPERIORITY|Sensitivity analysis of the association between the intervention and ACP billing, adjusted for time, patient characteristics, hospital characteristics, and the interaction between step of the trial and the intervention.|Odds Ratio (OR)|1.03||||0.74|TWO_SIDED|95.0|0.89|1.19|||Mixed Models Analysis|Overall effect allowing effect heterogeneity across steps \<0.001 Interaction effect \<0.001|Step 1 cohort|||1.19|0.89|0.74
72419222|NCT04557930|144348757|SUPERIORITY||Odds Ratio (OR)|1.15||||0.09|TWO_SIDED|95.0|0.98|1.36|||Mixed Models Analysis|||Sensitivity analysis of the association between the intervention and ACP billing, adjusted for time, patient characteristics, hospital characteristics, and the interaction between step of the trial and the intervention.|Step 2 cohort|1.36|0.98|0.09
72419223|NCT04557930|144348757|SUPERIORITY||Odds Ratio (OR)|1.13||||0.11|TWO_SIDED|95.0|0.97|1.33|||Mixed Models Analysis|||Sensitivity analysis of the association between the intervention and ACP billing, adjusted for time, patient characteristics, hospital characteristics, and the interaction between step of the trial and the intervention.|Step 3 cohort|1.33|0.97|0.11
72419224|NCT04557930|144348757|SUPERIORITY||Odds Ratio (OR)|0.66|||<|0.001|TWO_SIDED|95.0|0.57|0.76|||Mixed Models Analysis||Step 4 cohort|Sensitivity analysis of the association between the intervention and ACP billing, adjusted for time, patient characteristics, hospital characteristics, and the interaction between step of the trial and the intervention.||0.76|0.57|<0.001
72419225|NCT04557930|144348757|SUPERIORITY||Odds Ratio (OR)|0.95||||0.49|TWO_SIDED|95.0|0.89|1.19|||Mixed Models Analysis|||Sensitivity analysis of the association between the intervention and ACP billing, adjusted for time, patient characteristics, hospital characteristics, and the interaction between step of the trial and the intervention.|Step 5 cohort|1.19|0.89|0.49
72419226|NCT00567190|144348773|SUPERIORITY||Cox Proportional Hazard|0.62|||<|0.0001|TWO_SIDED|95.0|0.51|0.75||Tested at two-sided 5% significance level|Log Rank (stratified)|Stratified by prior treatment status and region|Hazard ratio is comparing Pertuzumab arm with Placebo arm.|The null hypothesis (H0) was that the survival distributions of PFS in the two treatments arms (pertuzumab vs. placebo) are the same. The alternative hypothesis (H1) was that the survival distribution of PFS in the experimental arm (pertuzumab) and control arm (placebo) are different.||0.75|0.51|<0.0001
72612087|NCT01933594|144752928|SUPERIORITY|||||||0.16|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 24 hours post infusion 4||||0.16
72612088|NCT01933594|144752929|SUPERIORITY|||||||0.37|||||||Wilcoxon (Mann-Whitney)|||||||0.37
72612089|NCT01933594|144752930|SUPERIORITY|||||||0.9|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 24 hours post infusion 1||||0.9
72326672|NCT05018689|144176663|SUPERIORITY||Mean Difference (Net)|0.04||||0.642|TWO_SIDED|95.0|-0.13|0.22|||Regression, Linear|||How confident to identify someone showing depression?||0.22|-0.13|0.642
72419227|NCT00567190|144348773|SUPERIORITY||Cox Proportional Hazard|0.63|||<|0.0001|TWO_SIDED|95.0|0.52|0.76||Tested at two-sided 5% significance level|Log Rank (unstratified)|Unstratified|Hazard ratio is comparing Pertuzumab arm with Placebo arm.|The null hypothesis (H0) was that the survival distributions of PFS in the two treatments arms (pertuzumab vs. placebo) are the same. The alternative hypothesis (H1) was that the survival distribution of PFS in the experimental arm (pertuzumab) and control arm (placebo) are different.||0.76|0.52|<0.0001
72612090|NCT01933594|144752930|SUPERIORITY|||||||0.07|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 24 hours post infusion 2||||0.07
72612091|NCT01933594|144752930|SUPERIORITY|||||||0.88|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 24 hours post infusion 3||||0.88
72612092|NCT01933594|144752930|SUPERIORITY|||||||0.92|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 24 hours post infusion 4||||0.92
72326673|NCT05018689|144176663|SUPERIORITY||Mean Difference (Net)|0.02||||0.864|TWO_SIDED|95.0|-0.21|0.25|||Regression, Linear|||How confident to help a friend?||0.25|-0.21|0.864
72326674|NCT05018689|144176664|SUPERIORITY||comparison of odds ratios|0.78||||0.336|TWO_SIDED|95.0|0.47|1.3|||Regression, Logistic|||||1.30|0.47|0.336
72612093|NCT01933594|144752931|SUPERIORITY|||||||0.44|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 6 hours post infusion||||0.44
72612094|NCT01933594|144752931|SUPERIORITY|||||||0.024|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 12 hours post infusion||||0.024
72612095|NCT01933594|144752931|SUPERIORITY|||||||0.37|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 7 days post infusion||||0.37
72612096|NCT01933594|144752931|SUPERIORITY|||||||0.79|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 14 days post infusion||||0.79
72612097|NCT01933594|144752931|SUPERIORITY|||||||0.34|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 28 days post infusion||||0.34
72612098|NCT01933594|144752932|SUPERIORITY|||||||0.029|||||||Wilcoxon (Mann-Whitney)|||||||0.029
72612099|NCT01933594|144752933|SUPERIORITY|||||||0.96|||||||Wilcoxon (Mann-Whitney)|||||||0.96
72612100|NCT01933594|144752934|SUPERIORITY|||||||0.54|||||||Wilcoxon (Mann-Whitney)|||||||0.54
72612101|NCT01933594|144752936|SUPERIORITY|||||||0.19|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 24 hours post infusion 1||||0.19
72612102|NCT01933594|144752936|SUPERIORITY|||||||0.63|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 24 hours post infusion 2||||0.63
72612103|NCT01933594|144752936|SUPERIORITY|||||||0.94|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 72 hours post infusion 2||||0.94
72612104|NCT01933594|144752936|SUPERIORITY|||||||0.66|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 24 hours post infusion 3||||0.66
72612105|NCT01933594|144752936|SUPERIORITY|||||||0.17|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 24 hours post infusion 4||||0.17
72612106|NCT01933594|144752937|SUPERIORITY|||||||0.73|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 24 hours post infusion||||0.73
72612107|NCT01933594|144752937|SUPERIORITY|||||||0.9|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 14 days post infusion||||0.9
72612108|NCT01933594|144752938|SUPERIORITY|||||||0.8|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 24 hours post infusion 1||||0.8
72612109|NCT01933594|144752938|SUPERIORITY|||||||0.73|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 24 hours post infusion 2||||0.73
72612110|NCT01933594|144752938|SUPERIORITY|||||||0.84|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 72 hours post infusion 2||||0.84
72612111|NCT01933594|144752938|SUPERIORITY|||||||0.88|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 24 hours post infusion 3||||0.88
72612112|NCT01933594|144752938|SUPERIORITY|||||||0.64|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 24 hours post infusion 4||||0.64
72612113|NCT01933594|144752946|SUPERIORITY|||||||0.34|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 24 hours post infusion 1||||0.34
72326675|NCT05018689|144176665|SUPERIORITY||comparison of odds ratios|1.05||||0.806|TWO_SIDED|95.0|0.7|1.59|||Regression, Logistic|||Depression runs in families. Answer: true||1.59|0.70|0.806
72326676|NCT05018689|144176665|SUPERIORITY||comparison of odds ratios|0.96||||0.781|TWO_SIDED|95.0|0.71|1.3|||Regression, Logistic|||Depression can be controlled through willpower. Answer: false||1.30|0.71|0.781
72326677|NCT05018689|144176665|SUPERIORITY||comparison of odds ratios|0.93||||0.72|TWO_SIDED|95.0|0.62|1.39|||Regression, Logistic|||Depression is treatable. Answer: true||1.39|0.62|0.720
72612114|NCT01933594|144752946|SUPERIORITY|||||||0.004|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 24 hours post infusion 2||||0.004
72612115|NCT01933594|144752946|SUPERIORITY|||||||0.022|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 24 hours post infusion 3||||0.022
72612116|NCT01933594|144752946|SUPERIORITY|||||||0.008|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 24 hours post infusion 4||||0.008
72612117|NCT01933594|144752946|SUPERIORITY|||||||0.55|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 2 weeks post infusion 4||||0.55
72612118|NCT01933594|144752946|SUPERIORITY|||||||0.48|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 5 weeks post infusion 4||||0.48
72612119|NCT01933594|144752946|SUPERIORITY|||||||0.54|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 10 weeks post infusion 4||||0.54
72612120|NCT01933594|144752946|SUPERIORITY|||||||0.47|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 18 weeks post infusion 4||||0.47
72612121|NCT01933594|144752948|SUPERIORITY|||||||0.95|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 48 hours post infusion||||0.95
72612122|NCT01933594|144752948|SUPERIORITY|||||||0.07|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 7 days post infusion||||0.07
72612123|NCT01933594|144752948|SUPERIORITY|||||||0.26|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 28 days post infusion||||0.26
72612124|NCT01933594|144752949|SUPERIORITY|||||||0.89|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 48 hours post infusion||||0.89
72612125|NCT01933594|144752949|SUPERIORITY|||||||0.14|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 7 days post infusion||||0.14
72612126|NCT01933594|144752949|SUPERIORITY|||||||0.74|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 28 days post infusion||||0.74
72612127|NCT01933594|144752950|SUPERIORITY|||||||0.71|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 48 hours post infusion||||0.71
72612128|NCT01933594|144752950|SUPERIORITY|||||||0.79|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 7 days post infusion||||0.79
72612129|NCT01933594|144752950|SUPERIORITY|||||||0.38|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 28 days post infusion||||0.38
72612130|NCT01933594|144752951|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 48 hours post infusion||||1
72612131|NCT01933594|144752951|SUPERIORITY|||||||0.92|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 7 days post infusion||||0.92
72612132|NCT01933594|144752951|SUPERIORITY|||||||0.66|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 28 days post infusion||||0.66
72612133|NCT01933594|144752952|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 24 hours post infusion 1||||1
72612134|NCT01933594|144752952|SUPERIORITY|||||||0.9|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 24 hours post infusion 4||||0.9
72612135|NCT01933594|144752952|SUPERIORITY|||||||0.47|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 10 weeks post infusion 4||||0.47
72612136|NCT01933594|144752953|SUPERIORITY|||||||0.63|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 24 hours post infusion 1||||0.63
72612137|NCT01933594|144752953|SUPERIORITY|||||||0.51|||||||Wilcoxon (Mann-Whitney)|||hange from baseline to 24 hours post infusion 4||||0.51
72612138|NCT01933594|144752953|SUPERIORITY|||||||0.028|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 10 weeks post infusion 4||||0.028
72612139|NCT01933594|144752954|SUPERIORITY|||||||0.62|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 24 hours post infusion 1||||0.62
72326678|NCT05018689|144176665|SUPERIORITY||comparison of odds ratios|1.11||||0.784|TWO_SIDED|95.0|0.52|2.38|||Regression, Logistic|||Abuse of alcohol and drugs can be a sign of depression. Answer: true||2.38|0.52|0.784
72326679|NCT05018689|144176665|SUPERIORITY||comparison of odds ratios|1.08||||0.662|TWO_SIDED|95.0|0.76|1.55|||Regression, Logistic|||Depression is a sign of personal weakness. Answer: false||1.55|0.76|0.662
72612140|NCT01933594|144752954|SUPERIORITY|||||||0.15|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 24 hours post infusion 4||||0.15
72326680|NCT05018689|144176666|SUPERIORITY||comparison of odds ratios|0.8||||0.34|TWO_SIDED|95.0|0.51|1.26|||Regression, Logistic|||Difficulty concentrating or making decisions||1.26|0.51|0.340
72326681|NCT05018689|144176666|SUPERIORITY||comparison of odds ratios|0.81||||0.265|TWO_SIDED|95.0|0.56|1.17|||Regression, Logistic|||Feeling angry||1.17|0.56|0.265
72326682|NCT05018689|144176666|SUPERIORITY||comparison of odds ratios|0.7||||0.259|TWO_SIDED|95.0|0.38|1.3|||Regression, Logistic|||Changes in sleep patterns||1.30|0.38|0.259
72326683|NCT05018689|144176666|SUPERIORITY||comparison of odds ratios|1.12||||0.45|TWO_SIDED|95.0|0.84|1.49|||Regression, Logistic|||Frequent unexplained aches and pains||1.49|0.84|0.450
72326684|NCT05018689|144176666|SUPERIORITY||comparison of odds ratios|2.28||||0.025|TWO_SIDED|95.0|1.11|4.69|||Regression, Logistic|||Feeling tired or less energetic||4.69|1.11|0.025
72326685|NCT05018689|144176666|SUPERIORITY||comparison of odds ratios|1.01||||0.937|TWO_SIDED|95.0|0.71|1.44|||Regression, Logistic|||Eating more than usual||1.44|0.71|0.937
72612141|NCT01933594|144752954|SUPERIORITY|||||||0.69|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 10 weeks post infusion 4||||0.69
72612142|NCT01933594|144752955|SUPERIORITY|||||||0.28|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 24 hours post infusion 1||||0.28
72612143|NCT01933594|144752955|SUPERIORITY|||||||0.15|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 24 hours post infusion 4||||0.15
72612144|NCT01933594|144752955|SUPERIORITY|||||||0.81|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 10 weeks post infusion 4||||0.81
72612145|NCT01933594|144752956|SUPERIORITY|||||||0.13|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 48 hours post infusion||||0.13
72612146|NCT01933594|144752956|SUPERIORITY|||||||0.22|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 7 days post infusion||||0.22
72612147|NCT01933594|144752956|SUPERIORITY|||||||0.031|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 28 days post infusion||||0.031
72612148|NCT01933594|144752957|SUPERIORITY|||||||0.13|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 48 hours post infusion||||0.13
72326686|NCT05018689|144176666|SUPERIORITY||comparison of odds ratios|0.83||||0.447|TWO_SIDED|95.0|0.52|1.34|||Regression, Logistic|||Feeling irritable or restless||1.34|0.52|0.447
72612149|NCT01933594|144752957|SUPERIORITY|||||||0.39|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 7 days post infusion||||0.39
72612150|NCT01933594|144752957|SUPERIORITY|||||||0.12|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 28 days post infusion||||0.12
72612151|NCT01933594|144752958|SUPERIORITY|||||||0.7|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 24 hours post infusion 1||||0.7
72612152|NCT01933594|144752958|SUPERIORITY|||||||0.51|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 24 hours post infusion 4||||0.51
72612153|NCT01933594|144752958|SUPERIORITY|||||||0.94|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 10 weeks post infusion 4||||0.94
72612154|NCT01933594|144752959|SUPERIORITY|||||||0.78|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 24 hours post infusion 1||||0.78
72612155|NCT01933594|144752959|SUPERIORITY|||||||0.41|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 24 hours post infusion 4||||0.41
72612156|NCT01933594|144752959|SUPERIORITY|||||||0.94|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 10 weeks post infusion 4||||0.94
72612157|NCT01933594|144752960|SUPERIORITY|||||||0.69|||||||Wilcoxon (Mann-Whitney)|||Change in pNFKB+% on CD4||||0.69
72612158|NCT01933594|144752960|SUPERIORITY|||||||0.27|||||||Wilcoxon (Mann-Whitney)|||Change in pS175% on CD4||||0.27
72612159|NCT01933594|144752961|SUPERIORITY|||||||0.81|||||||Wilcoxon (Mann-Whitney)|||Change in pNFKB+% on CD8||||0.81
72612160|NCT01933594|144752961|SUPERIORITY|||||||0.81|||||||Wilcoxon (Mann-Whitney)|||Change in pS175% on CD8||||0.81
72612161|NCT01933594|144752962|SUPERIORITY|||||||0.37|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 24 hours post infusion 1||||0.37
72326687|NCT05018689|144176667|SUPERIORITY||Mean Difference (Net)|0.02||||0.8|TWO_SIDED|95.0|-0.11|0.14|||Regression, Linear|||Friend||0.14|-0.11|0.800
72326688|NCT05018689|144176667|SUPERIORITY||Mean Difference (Net)|-0.05||||0.451|TWO_SIDED|95.0|-0.18|0.08|||Regression, Linear|||Parent/guardian||0.08|-0.18|0.451
72612162|NCT01933594|144752962|SUPERIORITY|||||||0.1|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 24 hours post infusion 2||||0.1
72326689|NCT05018689|144176667|SUPERIORITY||Mean Difference (Net)|0.07||||0.335|TWO_SIDED|95.0|-0.07|0.2|||Regression, Linear|||School counselor||0.2|-0.07|0.335
72326690|NCT05018689|144176667|SUPERIORITY||Mean Difference (Net)|-0.04||||0.554|TWO_SIDED|95.0|-0.17|0.09|||Regression, Linear|||Teacher||0.09|-0.17|0.554
72326691|NCT05018689|144176667|SUPERIORITY||Mean Difference (Net)|-0.04||||0.541|TWO_SIDED|95.0|-0.19|0.1|||Regression, Linear|||Mental health professional||0.10|-0.19|0.541
72326692|NCT05018689|144176667|SUPERIORITY||Mean Difference (Net)|0.05||||0.454|TWO_SIDED|95.0|-0.09|0.19|||Regression, Linear|||Doctor||0.19|-0.09|0.454
72612163|NCT01933594|144752962|SUPERIORITY|||||||0.28|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 72 hours post infusion 2||||0.28
72612164|NCT01933594|144752962|SUPERIORITY|||||||0.16|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 24 hours post infusion 3||||0.16
72612165|NCT01933594|144752962|SUPERIORITY|||||||0.12|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 24 hours post infusion 4||||0.12
72612166|NCT01933594|144752963|SUPERIORITY|||||||0.027|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 24 hours post infusion 1||||0.027
72612167|NCT01933594|144752963|SUPERIORITY|||||||0.004|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 24 hours post infusion 2||||0.004
72612168|NCT01933594|144752963|SUPERIORITY|||||||0.1|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 72 hours post infusion 2||||0.1
72612169|NCT01933594|144752963|SUPERIORITY|||||||0.022|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 24 hours post infusion 3||||0.022
72612170|NCT01933594|144752963|SUPERIORITY|||||||0.17|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 24 hours post infusion 4||||0.17
72612171|NCT00315445|144752972|SUPERIORITY_OR_OTHER|||||||0.035||||||P values are from a repeated measures model|Mixed Models Analysis|||A repeated measures analysis was performed to assess the effects due to treatment, center, and treatment by center interaction. Observations within each subject were assumed to follow a first-order autoregressive model. Missing values were extrapolated by the last observation carried forward (LOCF). Covariates were gender, age, race, weight, baseline pain, and previous opioid use which were incorporated into the model when P \< 0.10, using a backward elimination procedure.||||0.0350
72612172|NCT00315445|144752972|SUPERIORITY_OR_OTHER|||||||0.0624||||||Repeated measures analysis to assess the effects due to treatment, center, and treatment by center. Missing values = last observation carried forward (LOCF). Covariates: gender, age, race, weight, baseline pain, and previous opioid use.|Mixed Models Analysis|||||||0.0624
72612173|NCT00315445|144752973|SUPERIORITY_OR_OTHER||Day 84 Mean|46.4|||||TWO_SIDED|90.0|40.2|48.7|||Day 84 Mean|||||48.7|40.2|
72612174|NCT00315445|144752973|SUPERIORITY_OR_OTHER||Day 84 Mean|44.5|||||TWO_SIDED|90.0|43.3|52.4|||Day 84 Mean|||||52.4|43.3|
72612175|NCT00315445|144752973|SUPERIORITY_OR_OTHER||Day 84 Mean|46.5|||||TWO_SIDED|90.0|41.7|50.2|||Day 84 Mean|||||50.2|41.7|
72612176|NCT00315445|144752974|SUPERIORITY_OR_OTHER||Day 84 Mean|18.9|||||TWO_SIDED|90.0|5.2|26.2|||Day 84 Mean|||||26.2|5.2|
72612177|NCT00315445|144752974|SUPERIORITY_OR_OTHER||Day 84 Mean|24.4|||||TWO_SIDED|90.0|10.7|32.0|||Day 84 Mean|||||32.0|10.7|
72612178|NCT00315445|144752974|SUPERIORITY_OR_OTHER||Day 84 Mean|33.9|||||TWO_SIDED|90.0|16.0|35.2|||Day 84 Mean|||||35.2|16.0|
72612179|NCT00315445|144752975|SUPERIORITY_OR_OTHER|||||||0.0452||||||Multiple linear regression|Mixed Models Analysis|||A repeated measures analysis was performed to assess the effects due to treatment, center, and treatment by center interaction. Observations within each subject were assumed to follow a first-order autoregressive model. Missing values were extrapolated by the last observation carried forward (LOCF). Covariates were gender, age, race, weight, baseline pain, and previous opioid use which were incorporated into the model when P \< 0.10, using a backward elimination procedure.||||0.0452
72612180|NCT00315445|144752975|SUPERIORITY_OR_OTHER|||||||0.0962|||||||Mixed Models Analysis|||||||0.0962
72612181|NCT00315445|144752976|SUPERIORITY_OR_OTHER||Day 84 Mean|35.3|||||TWO_SIDED|90.0|24.3|35.6|||Day 84 Mean|||||35.6|24.3|
72612182|NCT00315445|144752976|SUPERIORITY_OR_OTHER||Day 84 Mean|39.0|||||TWO_SIDED|90.0|29.0|40.3|||Day 84 Mean|||||40.3|29.0|
72612183|NCT00315445|144752976|SUPERIORITY_OR_OTHER||Day 84 Mean|41.9|||||TWO_SIDED|90.0|32.1|42.5|||Day 84 Mean|||||42.5|32.1|
72612184|NCT00315445|144752977|SUPERIORITY_OR_OTHER||Day 84 Mean|52.4||||||90.0|50.3|56.6|||Day 84 Mean|||||56.6|50.3|
72612185|NCT00315445|144752977|SUPERIORITY_OR_OTHER||Day 84 Mean|52.5|||||TWO_SIDED|90.0|51.8|58.3|||Day 84 Mean|||||58.3|51.8|
72612186|NCT00315445|144752977|SUPERIORITY_OR_OTHER||Day 84 Mean|57.7|||||TWO_SIDED|90.0|52.3|58.6|||Day 84 Mean|||||58.6|52.3|
72326693|NCT05018689|144176667|SUPERIORITY||Mean Difference (Net)|-0.02||||0.749|TWO_SIDED|95.0|-0.16|0.12|||Regression, Linear|||Internet/website||0.12|-0.16|0.749
72612187|NCT00315445|144752980|SUPERIORITY_OR_OTHER||Day 84 Mean|55.3|||||TWO_SIDED|90.0|49.8|67.9|||Day 84 Mean|||||67.9|49.8|
72612188|NCT00315445|144752980|SUPERIORITY_OR_OTHER||Day 84 Mean|56.3|||||TWO_SIDED|90.0|45.9|65.3|||Day 84 Mean|||||65.3|45.9|
72612189|NCT00315445|144752980|SUPERIORITY_OR_OTHER||Day 84 Mean|63.0|||||TWO_SIDED|90.0|53.1|70.9|||Day 84 Mean|||||70.9|53.1|
72612190|NCT00315445|144752981|SUPERIORITY_OR_OTHER||Day 84 Mean|67.4|||||TWO_SIDED|90.0|61.3|68.6|||Day 84 Mean|||||68.6|61.3|
72612191|NCT00315445|144752981|SUPERIORITY_OR_OTHER||Day 84 Mean|68.8|||||TWO_SIDED|90.0|61.7|68.8|||Day 84 Mean|||||68.8|61.7|
72612192|NCT00315445|144752981|SUPERIORITY_OR_OTHER||Day 84 Mean|67.8|||||TWO_SIDED|90.0|62.0|68.7|||Day 84 Mean|||||68.7|62.0|
72612193|NCT00315445|144752986|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.67||||0.054|||||||Regression, Cox|For the secondary outcome measure no alpha adjustment for multiple comparison was performed.||||||0.054
72612194|NCT00315445|144752986|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.51||||0.138|||||||Regression, Cox|For the secondary outcome measure no alpha adjustment for multiple comparison was performed.||||||0.138
72612195|NCT00315445|144752987|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.3||||0.0105|||||||Regression, Cox|For the secondary outcomes no alpha adjustment for multiple comparison was performed.||||||0.0105
72612196|NCT00315445|144752987|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.04||||0.0024|||||||Regression, Cox|For the secondary outcome measure no alpha adjustment for multiple comparison was performed.||||||0.0024
72612197|NCT00315445|144752988|SUPERIORITY_OR_OTHER|||||||0.033|||||||Mixed Models Analysis|||||||.033
72612198|NCT00315445|144752988|SUPERIORITY_OR_OTHER|||||||0.043|||||||Mixed Models Analysis|||||||.043
72612199|NCT00315445|144752989|SUPERIORITY_OR_OTHER|||||||0.011|||||||Mixed Models Analysis|||||||.011
72612200|NCT00315445|144752989|SUPERIORITY_OR_OTHER|||||||0.034|||||||Mixed Models Analysis|||||||.034
72612201|NCT00315445|144752990|SUPERIORITY_OR_OTHER|||||||0.038|||||||Mixed Models Analysis|||||||.038
72612202|NCT00315445|144752990|SUPERIORITY_OR_OTHER|||||||0.63|||||||Mixed Models Analysis|||||||0.63
72612203|NCT00315445|144752991|SUPERIORITY_OR_OTHER|||||||0.064|||||||Mixed Models Analysis|||||||.064
72612204|NCT00315445|144752991|SUPERIORITY_OR_OTHER|||||||0.066|||||||Mixed Models Analysis|||||||.066
72612205|NCT00315445|144752992|SUPERIORITY_OR_OTHER|||||||0.607|||||||Mixed Models Analysis|||||||.607
72612206|NCT00315445|144752992|SUPERIORITY_OR_OTHER|||||||0.94|||||||Mixed Models Analysis|||||||.940
72612207|NCT00315445|144752993|SUPERIORITY_OR_OTHER|||||||0.702|||||||Mixed Models Analysis|||||||.702
72612208|NCT00315445|144752993|SUPERIORITY_OR_OTHER|||||||0.634|||||||Mixed Models Analysis|||||||.634
72612209|NCT02598661|144753038|SUPERIORITY||Percentage Difference|24.8|||<|0.001|TWO_SIDED|95.0|9.9|36.89||The p-value was calculated based on Cochran-Mantel-Haenszel (CMH) controlling for prior RBC transfusion burden (≤6 versus\[vs.\]\>6 units RBC) \& international prognostic scoring system (IPSS) risk group (low vs. intermediate-1) applied to randomization.|Cochran-Mantel-Haenszel||The 95% CI was calculated based on the Wilson Score method.|||36.89|9.90|<0.001
72612210|NCT02598661|144753040|SUPERIORITY||Percentage Difference|24.6|||<|0.001|TWO_SIDED|95.0|12.64|34.18||The p-value was calculated based on CMH controlling for prior RBC transfusion burden (≤6 vs. \>6 units RBC) and IPSS risk group (low vs. intermediate-1) applied to randomization.|Cochran-Mantel-Haenszel||The 95% CI was calculated based on the Wilson Score method.|||34.18|12.64|<0.001
72612211|NCT02598661|144753043|SUPERIORITY||Hazard Ratio (HR)|0.25|||<|0.001|TWO_SIDED|95.0|0.105|0.586||The p-value (2-sided) was calculated using the stratified log-rank test for superiority of imetelstat sodium versus placebo in hazard ratio.|Log Rank||Hazard ratio and 95% CI were calculated using the Cox proportional hazard model, stratified by prior RBC transfusion burden (≤ 6 vs. \> 6 units RBC) and IPSS risk group (low vs. intermediate-1), with treatment as the only covariate.|||0.586|0.105|<0.001
72612212|NCT02598661|144753044|SUPERIORITY||Percentage Difference|11.9||||0.112|TWO_SIDED|95.0|-4.1|27.56||The p-value was calculated based on CMH controlling for prior RBC transfusion burden (≤ 6 vs. \> 6 units RBC) and IPSS risk group (low vs. intermediate-1) applied to randomization.|Cochran-Mantel-Haenszel||95% CI was calculated based on the Wilson Score Method.|||27.56|-4.10|0.112
72612213|NCT02598661|144753047|SUPERIORITY||Hazard Ratio (HR)|0.98||||0.949|TWO_SIDED|95.0|0.526|1.823||P value (two-sided) for superiority of imetelstat sodium versus placebo in hazard ratio was calculated using stratified log-rank test.|Log Rank||Hazard ratio and 95% CI were calculated from the Cox proportional hazard model, stratified by prior RBC transfusion burden (≤6 vs. \>6 units RBC) and IPSS risk group (low vs. intermediate-1), with treatment as the only covariate.|||1.823|0.526|0.949
72612214|NCT02631057|144753190|SUPERIORITY_OR_OTHER||Mean|-2.484|STANDARD_ERROR_OF_MEAN|0.629|<|0.001|TWO_SIDED|95.0|-3.717|-1.251|||Abadie-Imbens|LoS Average Treatment Effect on the Treated (ATET) \[Dabigatran group\], dispersion analysed with Abadie-Imbens's standard error.|The ATET of LoS from oral anticoagulant initiation to hospital discharge was calculated as \[Dabigatran - Warfarin\] in the matched cohort of matching ratio 1:3.|||-1.251|-3.717|<0.001
72612215|NCT02471339|144753231|SUPERIORITY|||||||0.05|||||||ANCOVA|||Analysis of covariance. Analyses for primary and secondary outcomes were two-tailed and alpha was set to 0.05. An a priori analysis suggested that, to detect a change of .68 standard deviation on the primary outcome measure between the two groups at .80 power, 41 patients per group would be needed.||||0.05
72326694|NCT05018689|144176667|SUPERIORITY||Mean Difference (Net)|-0.13||||0.03|TWO_SIDED|95.0|-0.24|-0.01|||Regression, Linear|||Clergy, priest, rabbi, or other religious person||-0.01|-0.24|0.030
72612216|NCT02471339|144753232|SUPERIORITY|||||||0.05|||||||ANCOVA|||||||0.05
72612217|NCT02471339|144753235|SUPERIORITY|||||||0.05|||||||t-test|||||||.05
72612218|NCT02471339|144753239|SUPERIORITY|||||||0.042|||||||ANOVA|||||||0.042
72612219|NCT00303186|144753295|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.75|STANDARD_DEVIATION|7.03|<|0.0001|TWO_SIDED|95.0|2.4|5.1|||t-test, 2 sided|||Statistical analysis was carried out between categories, Baseline and Month 12.||5.10|2.40|<0.0001
72612220|NCT00303186|144753295|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.72|STANDARD_DEVIATION|7.47|<|0.001|TWO_SIDED|95.0|1.65|5.78|||t-test, 2 sided|||Statistical analysis was carried out between categories, Baseline and Month 60.||5.78|1.65|<0.001
72612221|NCT00303186|144753295|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.37|STANDARD_DEVIATION|4.1||0.518|TWO_SIDED|95.0|-1.5|0.76|||t-test, 2 sided|||Statistical analysis was carried out between categories, Month 12 and Month 60.||0.76|-1.50|0.518
72612222|NCT00303186|144753296|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|17.72|STANDARD_DEVIATION|27.89|<|0.0001|TWO_SIDED|95.0|12.38|23.07|||t-test, 2 sided|||Statistical analysis was carried out between categories, Baseline and Month 12.||23.07|12.38|<0.0001
72612223|NCT00303186|144753296|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.6|STANDARD_DEVIATION|20.36|<|0.0001|TWO_SIDED|95.0|6.99|18.21|||t-test, 2 sided|||Statistical analysis was carried out between categories, Baseline and Month 60.||18.21|6.99|<0.0001
72612224|NCT00303186|144753296|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.55|STANDARD_DEVIATION|18.7||0.833|TWO_SIDED|95.0|-5.7|4.61|||t-test, 2 sided|||Statistical analysis was carried out between categories, Month 12 and Month 60.||4.61|-5.70|0.833
72612225|NCT00303186|144753297|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.72|STANDARD_DEVIATION|2.39|<|0.0001|TWO_SIDED|95.0|2.26|3.18|||t-test, 2 sided|||Statistical analysis was carried out between categories, Baseline and Month 12.||3.18|2.26|<0.0001
72612226|NCT00303186|144753297|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.23|STANDARD_DEVIATION|2.36|<|0.0001|TWO_SIDED|95.0|1.59|2.87|||t-test, 2 sided|||Statistical analysis was carried out between categories, Baseline and Month 60.||2.87|1.59|<0.0001
72612227|NCT00303186|144753297|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.28|STANDARD_DEVIATION|2.03||0.309|TWO_SIDED|95.0|-0.83|0.27|||t-test, 2 sided|||Statistical analysis was carried out between categories, Month 12 and Month 60.||0.27|-0.83|0.309
72612228|NCT00303186|144753299|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.66|STANDARD_DEVIATION|11.75||0.004|TWO_SIDED|95.0|1.619|8.301|||t-test, 2 sided|||Statistical analysis was carried out between categories, Baseline and Month 60.||8.301|1.619|0.004
72326695|NCT05018689|144176667|SUPERIORITY||Mean Difference (Net)|0.06||||0.334|TWO_SIDED|95.0|-0.06|0.18|||Regression, Linear|||Phone helpline||0.18|-0.06|0.334
72326696|NCT05018689|144176667|SUPERIORITY||Mean Difference (Net)|0.07||||0.243|TWO_SIDED|95.0|-0.05|0.2|||Regression, Linear|||Crisis textline||0.20|-0.05|0.243
72326697|NCT05018689|144176667|SUPERIORITY||Mean Difference (Net)|-0.05||||0.492|TWO_SIDED|95.0|-0.19|0.09|||Regression, Linear|||Other relative (i.e., sister, brother, aunt, uncle)||0.09|-0.19|0.492
72326698|NCT05018689|144176667|SUPERIORITY||Mean Difference (Net)|-0.04||||0.61|TWO_SIDED|95.0|-0.17|0.1|||Regression, Linear|||Boyfriend or girlfriend||0.10|-0.17|0.610
72326699|NCT05018689|144176667|SUPERIORITY||Mean Difference (Net)|-0.12||||0.061|TWO_SIDED|95.0|-0.25|0.01|||Regression, Linear|||Coach||0.01|-0.25|0.061
72326700|NCT05018689|144176668|SUPERIORITY||comparison of odds ratios|1.27||||0.086|TWO_SIDED|95.0|0.97|1.66|||Regression, Logistic|||If you had depression symptoms for more than 2 weeks, would you ask for help?||1.66|0.97|0.086
72326701|NCT05018689|144176668|SUPERIORITY||comparison of odds ratios|1.13||||0.526|TWO_SIDED|95.0|0.77|1.66|||Regression, Logistic|||If you thought you had mental health issues, is there a trusted adult you would go to?||1.66|0.77|0.526
72326702|NCT05018689|144176669|SUPERIORITY||Mean Difference (Net)|0.06||||0.199|TWO_SIDED|95.0|-0.03|0.16|||Regression, Linear|||Do you know how to get help in your school?||0.16|-0.03|0.199
72326703|NCT05018689|144176670|SUPERIORITY||Mean Difference (Net)|-0.25|||<|0.001|TWO_SIDED|95.0|-0.38|-0.12|||Regression, Linear|||The new student is more dangerous than other students||-0.12|-0.38|<0.001
72326704|NCT05018689|144176670|SUPERIORITY||Mean Difference (Net)|-0.18||||0.003|TWO_SIDED|95.0|-0.29|-0.06|||Regression, Linear|||The student is to blame for his or her condition||-0.06|-0.29|0.003
72326705|NCT05018689|144176670|SUPERIORITY||Mean Difference (Net)|0.06||||0.31|TWO_SIDED|95.0|-0.06|0.18|||Regression, Linear|||I would have sympathy for the new student||0.18|-0.06|0.310
72326706|NCT05018689|144176670|SUPERIORITY||Mean Difference (Net)|-0.1||||0.114|TWO_SIDED|95.0|-0.21|0.02|||Regression, Linear|||The new student makes me feel scared||0.02|-0.21|0.114
72326707|NCT05018689|144176670|SUPERIORITY||Mean Difference (Net)|0.02||||0.738|TWO_SIDED|95.0|-0.1|0.15|||Regression, Linear|||The new student makes me feel uncomfortable||0.15|-0.10|0.738
72326708|NCT05018689|144176670|SUPERIORITY||Mean Difference (Net)|0.12||||0.04|TWO_SIDED|95.0|0.01|0.24|||Regression, Linear|||I would help the new student even if I did not know him or her well||0.24|0.01|0.040
72326709|NCT05018689|144176670|SUPERIORITY||Mean Difference (Net)|-0.17||||0.006|TWO_SIDED|95.0|-0.29|-0.05|||Regression, Linear|||I would try to stay away from the new student||-0.05|-0.29|0.006
72326710|NCT05018689|144176670|SUPERIORITY||Mean Difference (Net)|-0.02||||0.798|TWO_SIDED|95.0|-0.15|0.11|||Regression, Linear|||The new student would be made fun of at my school||0.11|-0.15|0.798
72326711|NCT05018689|144176670|SUPERIORITY||Mean Difference (Net)|-0.09||||0.197|TWO_SIDED|95.0|-0.22|0.05|||Regression, Linear|||The new student would be ignored at my school||0.05|-0.22|0.197
72326712|NCT05018689|144176670|SUPERIORITY||Mean Difference (Net)|0.03||||0.623|TWO_SIDED|95.0|-0.1|0.16|||Regression, Linear|||I think other students in my school would try to help the new student||0.16|-0.10|0.623
72326713|NCT05018689|144176671|SUPERIORITY||Mean Difference (Net)|0.05||||0.718|TWO_SIDED|95.0|-0.21|0.3|||Regression, Linear|||On a scale from 1 to 7, if you were seen going into the office of your school social worker or school psychologist, how would you feel?||0.30|-0.21|0.718
72326714|NCT05018689|144176672|SUPERIORITY||Mean Difference (Net)|0.21||||0.09|TWO_SIDED|95.0|-0.03|0.46|||Regression, Linear|||How comfortable are you talking about mental health issues with other students at your school?||0.46|-0.03|0.090
72326715|NCT05018689|144176673|SUPERIORITY||comparison of odds ratios|0.99||||0.944|TWO_SIDED|95.0|0.67|1.44|||Regression, Logistic|||Depression||1.44|0.67|0.944
72419228|NCT00567190|144348774|SUPERIORITY|Exploratory|Cox Proportional Hazard|0.69|||<|0.0001|TWO_SIDED|95.0|0.58|0.82||Exploratory|Log Rank (stratified)|Stratified by prior treatment status and region.|Hazard ratio is comparing Pertuzumab arm with Placebo arm.|End-of-Study OS Analysis: This end-of-study OS analysis is considered exploratory only as the confirmatory OS analysis for statistical interpretation had previously occurred at the second interim OS analysis.||0.82|0.58|<0.0001
72419229|NCT00567190|144348774|SUPERIORITY|Exploratory|Cox Proportional Hazard|0.68||||0.0002|TWO_SIDED|95.0|0.56|0.84||Exploratory|Log Rank (stratified)|Stratified by prior treatment status and region.|Hazard ratio is comparing Pertuzumab arm with Placebo arm.|Event-Driven Final OS Analysis: This final OS analysis was event-driven and planned to take place after a total of 385 deaths had occurred. It is considered exploratory only as the confirmatory OS analysis for statistical interpretation had previously occurred at the second interim OS analysis.||0.84|0.56|0.0002
72419230|NCT00567190|144348774|SUPERIORITY||Cox Proportional Hazard|0.66||||0.0008|TWO_SIDED|95.0|0.52|0.84||The threshold for statistical significance was HR≤0.739, p≤0.0138.|Log Rank (stratified)|Stratified by prior treatment status and region.|Hazard ratio (HR) is comparing Pertuzumab arm with Placebo arm.|Second Interim OS Analysis: For this second interim OS analysis, the pre-defined O'Brien-Fleming stopping boundary for the Lan-DeMets α-spending function was: HR≤0.739, p≤0.0138.||0.84|0.52|0.0008
72326716|NCT05018689|144176673|SUPERIORITY||comparison of odds ratios|1.18||||0.369|TWO_SIDED|95.0|0.82|1.68|||Regression, Logistic|||Anxiety||1.68|0.82|0.369
72326717|NCT05018689|144176673|SUPERIORITY||comparison of odds ratios|1.07||||0.676|TWO_SIDED|95.0|0.77|1.5|||Regression, Logistic|||Thoughts of suicide||1.50|0.77|0.676
72326718|NCT05018689|144176673|SUPERIORITY||comparison of odds ratios|0.79||||0.432|TWO_SIDED|95.0|0.44|1.42|||Regression, Logistic|||I do not think there are any mental health issues that are concerning for students||1.42|0.44|0.432
72326719|NCT05018689|144176673|SUPERIORITY||comparison of odds ratios|0.87||||0.533|TWO_SIDED|95.0|0.56|1.35|||Regression, Logistic|||Other||1.35|0.56|0.533
72612229|NCT00303186|144753300|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.76|STANDARD_DEVIATION|18.8||0.015|TWO_SIDED|95.0|-12.155|-1.355|||t-test, 2 sided|||Statistical analysis was carried out between categories, Baseline and Month 60.||-1.355|-12.155|0.015
72326720|NCT05018689|144176674|SUPERIORITY||Mean Difference (Net)|-0.01||||0.769|TWO_SIDED|95.0|-0.11|0.08|||Regression, Linear|||How much do your teachers know about addressing student mental health needs?||0.08|-0.11|0.769
72326721|NCT05018689|144176674|SUPERIORITY||Mean Difference (Net)|0.05||||0.315|TWO_SIDED|95.0|-0.05|0.16|||Regression, Linear|||How much do your school counselors know about addressing student mental health needs?||0.16|-0.05|0.315
72326722|NCT05018689|144176675|SUPERIORITY||comparison of odds ratios|0.86||||0.345|TWO_SIDED|95.0|0.63|1.18|||Regression, Logistic|||Mental health information sheets at school||1.18|0.63|0.345
72326723|NCT05018689|144176675|SUPERIORITY||comparison of odds ratios|0.98||||0.899|TWO_SIDED|95.0|0.73|1.33|||Regression, Logistic|||Class activities about mental health||1.33|0.73|0.899
72326724|NCT05018689|144176675|SUPERIORITY||comparison of odds ratios|1.08||||0.612|TWO_SIDED|95.0|0.8|1.48|||Regression, Logistic|||Mental health information on school website||1.48|0.80|0.612
72326725|NCT05018689|144176675|SUPERIORITY||comparison of odds ratios|1.14||||0.476|TWO_SIDED|95.0|0.79|1.65|||Regression, Logistic|||Other||1.65|0.79|0.476
72326726|NCT05018689|144176676|SUPERIORITY||Mean Difference (Net)|-0.09||||0.141|TWO_SIDED|95.0|-0.22|0.03|||Regression, Linear|||On average, how often do your teachers speak to you about your emotions and feelings?||0.03|-0.22|0.141
72326727|NCT05018689|144176677|SUPERIORITY||Mean Difference (Net)|0.04||||0.392|TWO_SIDED|95.0|-0.05|0.13|||Regression, Linear|||Would you like your teachers to speak to you about your emotions and feelings?||0.13|-0.05|0.392
72326728|NCT02651116|144176681|SUPERIORITY||Rate Ratio|0.7899|STANDARD_ERROR_OF_MEAN|0.0929||0.0449|TWO_SIDED|95.0|0.6273|0.9947||P-Value less than or equal to (\<=) 0.05 level was considered significantly better and P-Value lying between 0.05 less than (\<) p\<=0.1 level was considered marginally significantly better.|Negative Binomial Regression|||Estimated rate ratio (ratio of rate of cough counts per 24 hours for DXM HBr to placebo), and corresponding 95% confidence interval (CI) for DXM HBr versus placebo was obtained from negative binomial model with treatment, study site (pooled), age group, and log-transformed baseline average cough count per hour as factors, with logarithm of the time over which the cough count was evaluated as the offset parameter.||0.9947|0.6273|0.0449
72419231|NCT00567190|144348774|SUPERIORITY||Cox Proportional Hazard|0.64||||0.005|TWO_SIDED|95.0|0.47|0.88||The threshold for statistical significance was HR≤0.603, p≤0.0012.|Log Rank (stratified)|Stratified by prior treatment status and region.|Hazard ratio (HR) is comparing pertuzumab with placebo arms.|First Interim OS Analysis: For this first interim OS analysis, the pre-defined O'Brien-Fleming stopping boundary for the Lan-DeMets α-spending function was: HR≤0.603, p≤0.0012.||0.88|0.47|0.0050
72612230|NCT00303186|144753301|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.44|STANDARD_DEVIATION|7.41||0.676|TWO_SIDED|95.0|-1.666|2.546|||t-test, 2 sided|||Statistical analysis was carried out between categories, Baseline and Month 60.||2.546|-1.666|0.676
72326729|NCT02651116|144176681|SUPERIORITY|||||||0.6293||||||P-value is for interaction term of treatment by age group. P-value \<=0.10 was considered significant for interaction terms.|Negative Binomial Regression|||P-value was obtained from the negative binomial model with treatment, study site (pooled), age group, log-transformed baseline average cough count per hour (based on Baseline Run-in Period) as factors, with interaction term of treatment by age group, and logarithm of the time over which the cough count was evaluated as the offset parameter.||||0.6293
72326730|NCT02651116|144176682|SUPERIORITY||Rate Ratio|0.8048|STANDARD_ERROR_OF_MEAN|0.0912||0.0552|TWO_SIDED|95.0|0.6446|1.0049||P-Value \<=0.05 level was considered significantly better and P-Value lying between 0.05\<p\<=0.1 level was considered marginally significantly better.|Negative Binomial Regression|||Estimated rate ratio (ratio of rate of cough counts per specified duration for DXM HBr to placebo, used in evaluation of this outcome measure), and corresponding 95% CI for DXM HBr versus placebo was obtained from negative binomial model with treatment, study site (pooled), age group, and log-transformed baseline average cough count per hour as factors, with logarithm of the time over which the cough count was evaluated as the offset parameter.||1.0049|0.6446|0.0552
72612231|NCT00303186|144753302|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.486|STANDARD_DEVIATION|2.96|<|0.0001|TWO_SIDED|95.0|0.918|2.05|||t-test, 2 sided|||Statistical analysis was carried out between categories, Baseline and Month 12.||2.05|0.918|<0.0001
72419232|NCT00567190|144348775|SUPERIORITY||Cox Proportional Hazard|0.69|||<|0.0001|TWO_SIDED|95.0|0.59|0.81|||Log Rank (stratified)|Stratified by prior treatment status and region.|Hazard ratio is comparing Pertuzumab arm with Placebo arm.|PFS by Investigator - Stratified||0.81|0.59|<0.0001
72419233|NCT00567190|144348776|SUPERIORITY||Difference in Objective Response Rates|10.83||||0.0011|TWO_SIDED|95.0|4.2|17.5|||Mantel Haenszel|Stratified by prior treatment status and region.|Difference in the objective response rates between arms is calculated as Pertuzumab arm minus Placebo arm. The 95% CI was calculated using the Hauck-Anderson method.|Difference in Objective Response (CR + PR) Between Arms||17.5|4.2|0.0011
72419234|NCT00567190|144348776|SUPERIORITY||Odds Ratio (OR)|1.79|||||TWO_SIDED|95.0|1.26|2.54||||||Odds Ratio for Objective Response (CR + PR)||2.54|1.26|
72419235|NCT00567190|144348777|SUPERIORITY||Cox Proportional Hazard|0.66|||||TWO_SIDED|95.0|0.51|0.85||||||||0.85|0.51|
72419236|NCT00567190|144348778|SUPERIORITY||Cox Proportional Hazard|0.97||||0.7161|TWO_SIDED|95.0|0.81|1.16||Stratified by prior treatment status and region.|Log Rank (stratified)||Hazard ratio is comparing Pertuzumab arm with Placebo arm.|||1.16|0.81|0.7161
72419237|NCT00567190|144348787|OTHER|||||||0.7174|||||||Wilcoxon Rank Sum Test|||Wilcoxon Test of Maximum Decrease in LVEF From BL||||0.7174
72419238|NCT03063294|144348806|SUPERIORITY||Difference in Difference|0.02|||||TWO_SIDED|95.0|-0.47|0.5|||||"The difference in difference equals the follow-up minus baseline change in Hassles scale results for the toolkit plus coaching clinics, minus the follow-up minus baseline change in the Hassles scale results for the toolkit only clinics."|"Zero-inflated negative binomial regression was used to obtain predicted mean Hassles scale scores for the toolkit only clinics and toolkit plus coaching clinics at baseline and follow-up, adjusting for study design and characteristics of survey respondents. The difference-in-difference was then computed as described below, under method of estimation. Bootstrap resampling was used to calculate the 95% confidence intervals around the predicted means and the difference-in-difference."||0.50|-0.47|
72419239|NCT02532179|144348811|SUPERIORITY||Mean Ratio|3.0|||<|0.001|TWO_SIDED|95.0|2.09|4.29||Null hypothesis: there is no difference in immune modulation over time|Mixed Models Analysis|||||4.29|2.09|<0.001
72419240|NCT02532179|144348812|SUPERIORITY||Mean Ratio|3.82|||<|0.001|TWO_SIDED|95.0|2.77|5.25||Null hypothesis: there is no difference in immune modulation over time|Mixed Models Analysis|||||5.25|2.77|<0.001
72419241|NCT02532179|144348813|SUPERIORITY||Mean Ratio|6.55|||<|0.001|TWO_SIDED|95.0|3.87|11.06||Null hypothesis: there is no difference in immune modulation over time|Mixed Models Analysis|||||11.06|3.87|<0.001
72419242|NCT00876915|144348815|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.695||||0.4795|TWO_SIDED|95.0|0.235|1.89|||stratified Cox|||||1.890|0.235|0.4795
72419243|NCT00876915|144348816|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|7.019||||0.0252|TWO_SIDED|95.0|1.236|131.632|||stratified Cox|||||131.632|1.236|0.0252
72419244|NCT04128293|144348833|OTHER||Ratio of Geometric Least Square Mean|0.877|||||TWO_SIDED|90.0|0.7585|1.0152|||||Relative bioavailability between treatment A and B assessed using analysis of variance with treatment, period, and sequence as fixed effects, participant as a random effect was performed on the natural log-transformed parameter of AUC(0-infinity).|||1.0152|0.7585|
72419245|NCT04128293|144348835|OTHER||Ratio of Geometric Least Square Mean|0.892|||||TWO_SIDED|90.0|0.7778|1.0239|||||Relative bioavailability between treatment A and B assessed using analysis of variance with treatment, period, and sequence as fixed effects, participant as a random effect was performed on the natural log-transformed parameter of AUC(0-t).|||1.0239|0.7778|
72612232|NCT00303186|144753302|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.0|STANDARD_DEVIATION|3.64|<|0.001|TWO_SIDED|95.0|1.01|2.99|||t-test, 1 sided|||Statistical analysis was carried out between categories, Baseline and Month 60.||2.99|1.01|<0.001
72612233|NCT00303186|144753302|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.56|STANDARD_DEVIATION|3.32||0.223|TWO_SIDED|95.0|-0.35|1.46|||t-test, 2 sided|||Statistical analysis was carried out between categories, Month 12 and Month 60.||1.46|-0.35|0.223
72419246|NCT04128293|144348837|OTHER||Ratio of Geometric Least Square Mean|0.946|||||TWO_SIDED|90.0|0.8594|1.0404|||||Relative bioavailability between treatment A and B assessed using analysis of variance with treatment, period, and sequence as fixed effects, participant as a random effect was performed on the natural log-transformed parameter of Cmax.|||1.0404|0.8594|
72419247|NCT04128293|144348840|OTHER||Median Difference (Final Values)|0.533||||0.4252|TWO_SIDED|90.0|-1.0|2.0||The p-value was assessed based on the Wilcoxon signed-rank test.|Wilcoxon signed-rank test||The median difference and the 90 percent (%) confidence interval of the median difference was estimated from Hodges-Lehmann estimate.|||2.0000|-1.0000|0.4252
72419248|NCT04128293|144348840|OTHER||Median Difference (Final Values)|1.0||||0.3125|TWO_SIDED|90.0|-0.75|5.25||The p-value was assessed based on the Wilcoxon rank sum test.|Wilcoxon rank sum test||The median difference and the 90% confidence interval of the median difference were estimated from Hodges-Lehmann estimate.|||5.2500|-0.7500|0.3125
72419249|NCT04186780|144348889|SUPERIORITY|"The differences between Shiitake and placebo groups were analyzed by the Chi-square test, Exact of Fisher test and Student's t-test.~Descriptions of all biochemical parameters were expressed as mean ± standard deviation. To investigate the differences in biochemical parameters between the groups, Analysis of Variance (ANOVA) with repeated measurements was applied. All results of biochemical parameters were normalized to logarithmic scale."|Mean Difference (Net)|2.5||||0.59|TWO_SIDED|95.0||||P \< 0.05 was accepted as statistically significant.|ANOVA||Difference between T0 and T66 in the placebo group and intervention group in total cholesterol.|||||0.59
72419250|NCT04186780|144348890|SUPERIORITY|"The differences between Shiitake and placebo groups were analyzed by the Chi-square test, Exact of Fisher test and Student's t-test.~Descriptions of all biochemical and oxidative stress parameters were expressed as mean ± standard deviation. To investigate the differences in biochemical parameters between the groups, Analysis of Variance (ANOVA) with repeated measurements was applied. All results of biochemical parameters and oxidative stress were normalized to logarithmic scale."|Mean Difference (Net)|0.4||||0.8284|TWO_SIDED|95.0||||P \< 0.05 was accepted as statistically significant.|ANOVA||Difference between T0 and T66 in the placebo group and intervention group.|||||0.8284
72612234|NCT00303186|144753303|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.33|STANDARD_DEVIATION|5.94|<|0.0001|TWO_SIDED|95.0|5.1|7.47|||t-test, 2 sided|||Statistical analysis was carried out between categories, Baseline: swollen joints and Month 12: swollen joints.||7.47|5.10|<0.0001
72612235|NCT00303186|144753303|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.2|STANDARD_DEVIATION|6.35|<|0.0001|TWO_SIDED|95.0|4.48|7.92|||t-test, 2 sided|||Statistical analysis was carried out between categories, Baseline: swollen joints and Month 60: swollen joints.||7.92|4.48|<0.0001
72419251|NCT04186780|144348891|SUPERIORITY||Median Difference (Net)|0.1||||0.0058|TWO_SIDED|95.0||||P \< 0.05 was accepted as statistically significant.|ANOVA||Difference between T0 and T66 in the placebo group compared to the intervention group.|||||0.0058
72612236|NCT00303186|144753303|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2|STANDARD_DEVIATION|2.09||0.479|TWO_SIDED|95.0|-0.36|0.76|||t-test, 2 sided|||Statistical analysis was carried out between categories, Month 12: swollen joints and Month 60: swollen joints.||0.76|-0.36|0.479
72612237|NCT00303186|144753303|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.0|STANDARD_DEVIATION|11.16|<|0.0001|TWO_SIDED|95.0|6.86|11.13|||t-test, 1 sided|||Statistical analysis was carried out between categories, Baseline: tender joints and Month 12: tender joints.||11.13|6.86|<0.0001
72612238|NCT00303186|144753303|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.6|STANDARD_DEVIATION|9.25|<|0.0001|TWO_SIDED|95.0|6.1|11.1|||t-test, 2 sided|||Statistical analysis was carried out between categories, Baseline: tender joints and Month 60: tender joints.||11.10|6.10|<0.0001
72612239|NCT00303186|144753303|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.66|STANDARD_DEVIATION|8.92||0.588|TWO_SIDED|95.0|-1.76|3.07|||t-test, 2 sided|||Statistical analysis was carried out between categories, Month 12: tender joints and Month 60: tender joints.||3.07|-1.76|0.588
72612240|NCT00303186|144753307|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.26|STANDARD_DEVIATION|11.29||0.33|TWO_SIDED|95.0|-1.3|3.82|||t-test, 2 sided|||Statistical analysis was carried out between categories, Baseline and Month 12.||3.82|-1.30|0.330
72612241|NCT00303186|144753307|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.56|STANDARD_DEVIATION|32.28||0.449|TWO_SIDED|95.0|-33.37|16.26|||t-test, 2 sided|||Statistical analysis was carried out between categories, Baseline and Month 60.||16.26|-33.37|0.449
72612242|NCT00303186|144753307|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.0|STANDARD_DEVIATION|38.17||0.165|TWO_SIDED|95.0|-37.04|7.04|||t-test, 2 sided|||Statistical analysis was carried out between categories, Month 12 and Month 60.||7.04|-37.04|0.165
72612243|NCT00303186|144753308|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|31.18|STANDARD_DEVIATION|24.48|<|0.0001|TWO_SIDED|95.0|26.44|35.91|||t-test, 2 sided|||Statistical analysis was carried out between categories, Baseline and Month 12.||35.91|26.44|<0.0001
72612244|NCT00303186|144753308|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|28.76|STANDARD_DEVIATION|23.24|<|0.0001|TWO_SIDED|95.0|22.42|35.1|||t-test, 2 sided|||Statistical analysis was carried out between categories, Baseline and Month 60.||35.10|22.42|<0.0001
72612245|NCT00303186|144753308|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.05|STANDARD_DEVIATION|24.6||0.538|TWO_SIDED|95.0|-8.7|4.6|||t-test, 2 sided|||Statistical analysis was carried out between categories, Month 12 and Month 60.||4.60|-8.70|0.538
72419252|NCT04186780|144348892|SUPERIORITY||Median Difference (Net)|0.8||||0.0384|TWO_SIDED|95.0||||P \< 0.05 was accepted as statistically significant.|ANOVA||Reduced difference in TBARS in the placebo group compared to the intervention group at T66.|||||0.0384
72612246|NCT00303186|144753309|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|33.83|STANDARD_DEVIATION|19.6|<|0.0001|TWO_SIDED|95.0|30.04|37.63|||t-test, 2 sided|||Statistical analysis was carried out between categories, Baseline and Month 12.||37.63|30.04|<0.0001
72612247|NCT00303186|144753309|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|38.04|STANDARD_DEVIATION|21.17|<|0.0001|TWO_SIDED|95.0|31.96|44.12|||t-test, 2 sided|||Statistical analysis was carried out between categories, Baseline and Month 60.||44.12|31.96|<0.0001
72612248|NCT00303186|144753309|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.38|STANDARD_DEVIATION|17.59||0.343|TWO_SIDED|95.0|-2.62|7.38|||t-test, 2 sided|||Statistical analysis was carried out between categories, Month 12 and Month 60.||7.38|-2.62|0.343
72612249|NCT00303186|144753310|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|31.18|STANDARD_DEVIATION|27.56|<|0.0001|TWO_SIDED|95.0|25.88|36.49|||t-test, 2 sided|||Statistical analysis was carried out between categories, Baseline and Month 12.||36.49|25.88|<0.0001
72612250|NCT00303186|144753310|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|28.8|STANDARD_DEVIATION|25.89|<|0.0001|TWO_SIDED|95.0|21.52|36.09|||t-test, 2 sided|||Statistical analysis was carried out between categories, Baseline and Month 60.||36.09|21.52|<0.0001
72612251|NCT00303186|144753310|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.33|STANDARD_DEVIATION|22.77||0.301|TWO_SIDED|95.0|-9.74|3.07|||t-test, 2 sided|||Statistical analysis was carried out between categories, Month 12 and Month 60.||3.07|-9.74|0.301
72612252|NCT00303186|144753311|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|26.21|STANDARD_DEVIATION|123.2|<|0.0001|TWO_SIDED|95.0|2.01|50.4|||Wilcoxon (Mann-Whitney)|||Statistical analysis was carried out between categories, Baseline and Month 12.||50.40|2.01|<0.0001
72612253|NCT00303186|144753311|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.19|STANDARD_DEVIATION|18.3|<|0.0001|TWO_SIDED|95.0|7.81|18.57|||Wilcoxon (Mann-Whitney)|||Statistical analysis was carried out between categories, Baseline and Month 60.||18.57|7.81|<0.0001
72612254|NCT00303186|144753311|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.31|STANDARD_DEVIATION|14.07||0.132|TWO_SIDED|95.0|-6.4|1.77|||Wilcoxon (Mann-Whitney)|||Statistical analysis was carried out between categories, Month 12 and Month 60.||1.77|-6.40|0.132
72326731|NCT02651116|144176683|SUPERIORITY||Rate Ratio|0.9551|STANDARD_ERROR_OF_MEAN|0.1491||0.7684|TWO_SIDED|95.0|0.7032|1.2971||P-Value \<=0.05 level was considered significantly better and P-Value lying between 0.05\<p\<=0.1 level was considered marginally significantly better.|Negative Binomial Regression|||Estimated rate ratio (ratio of rate of cough counts per specified duration for DXM HBr to placebo, used in evaluation of this outcome measure), and corresponding 95% CI for DXM HBr versus placebo was obtained from negative binomial model with treatment, study site (pooled), age group, and log-transformed baseline average cough count per hour as factors, with logarithm of the time over which the cough count was evaluated as the offset parameter.||1.2971|0.7032|0.7684
72612255|NCT00303186|144753312|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.26|STANDARD_DEVIATION|150.1|<|0.0005|TWO_SIDED|95.0|-13.52|46.04|||Wilcoxon (Mann-Whitney)|||Statistical analysis was carried out between categories, Baseline and Month 12.||46.04|-13.52|<0.0005
72612256|NCT00303186|144753312|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|52.81|STANDARD_DEVIATION|100.25|<|0.0001|TWO_SIDED|95.0|22.33|83.29|||Wilcoxon (Mann-Whitney)|||Statistical analysis was carried out between categories, Baseline and Month 60.||83.29|22.33|<0.0001
72612257|NCT00303186|144753312|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|33.4|STANDARD_DEVIATION|147.25||0.034|TWO_SIDED|95.0|-10.84|77.64|||Wilcoxon (Mann-Whitney)|||Statistical analysis was carried out between categories, Month 12 and Month 60.||77.64|-10.84|0.034
72612258|NCT00303186|144753314|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.48|STANDARD_DEVIATION|0.66|<|0.0001|TWO_SIDED|95.0|0.35|0.62|||t-test, 2 sided|||Statistical analysis was carried out between categories, Baseline and Month 12.||0.62|0.35|<0.0001
72612259|NCT00303186|144753314|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.41|STANDARD_DEVIATION|0.56|<|0.0001|TWO_SIDED|95.0|0.26|0.56|||t-test, 2 sided|||Statistical analysis was carried out between categories, Baseline and Month 60.||0.56|0.26|<0.0001
72612260|NCT00303186|144753314|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.05|STANDARD_DEVIATION|0.61||0.6|TWO_SIDED|95.0|-0.24|0.14|||t-test, 2 sided|||Statistical analysis was carried out between categories, Month 12 and Month 60.||0.14|-0.24|0.600
72612261|NCT00303186|144753315|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.25|STANDARD_DEVIATION|0.31|<|0.0001|TWO_SIDED|95.0|0.18|0.3|||t-test, 2 sided|||Statistical analysis was carried out between categories, Baseline and Month 12.||0.30|0.18|<0.0001
72612262|NCT00303186|144753315|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.22|STANDARD_DEVIATION|0.34|<|0.0001|TWO_SIDED|95.0|-0.31|-0.12|||t-test, 2 sided|||Statistical analysis was carried out between categories, Baseline and Month 60.||-0.12|-0.31|<0.0001
72612263|NCT00303186|144753315|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01|STANDARD_DEVIATION|0.27||0.789|TWO_SIDED|95.0|-0.08|0.06|||t-test, 2 sided|||Statistical analysis was carried out between categories, Month 12 and Month 60.||0.06|-0.08|0.789
72612264|NCT00303186|144753316|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|19.4|STANDARD_DEVIATION|25.0|<|0.0001|TWO_SIDED|95.0|14.59|24.22|||t-test, 2 sided|||Statistical analysis was carried out between categories, Baseline and Month 12.||24.22|14.59|<0.0001
72612265|NCT00303186|144753316|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.68|STANDARD_DEVIATION|22.08||0.0001|TWO_SIDED|95.0|-18.77|-6.59|||t-test, 2 sided|||Statistical analysis was carried out between categories, Baseline and Month 60.||-6.59|-18.77|0.0001
72612266|NCT00303186|144753316|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.85|STANDARD_DEVIATION|22.22||0.115|TWO_SIDED|95.0|-1.21|10.92|||t-test, 2 sided|||Statistical analysis was carried out between categories, Month 12 and Month 60.||10.92|-1.21|0.115
72612267|NCT00303186|144753317|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.41|STANDARD_DEVIATION|10.1|<|0.0001|TWO_SIDED|95.0|-10.34|-4.47|||t-test, 2 sided|||Statistical analysis was carried out between categories, Baseline: physical component score and Month 12: physical component score.||-4.47|-10.34|<0.0001
72612268|NCT00303186|144753317|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.94|STANDARD_DEVIATION|9.13|<|0.0001|TWO_SIDED|95.0|-8.56|-3.32|||t-test, 2 sided|||Statistical analysis was carried out between categories, Baseline: physical component score and Month 60: physical component score.||-3.32|-8.56|<0.0001
72612269|NCT00303186|144753317|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.25|STANDARD_DEVIATION|8.83||0.308|TWO_SIDED|95.0|-1.19|3.68|||t-test, 2 sided|||Statistical analysis was carried out between categories, Month 12: physical component score and Month 60: physical component score.||3.68|-1.19|0.308
72612270|NCT00303186|144753317|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.67|STANDARD_DEVIATION|8.51||0.589|TWO_SIDED|95.0|-3.14|1.8|||t-test, 2 sided|||Statistical analysis was carried out between categories, Baseline: mental component score and Month 12: mental component score.||1.80|-3.14|0.589
72612271|NCT00303186|144753317|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.59|STANDARD_DEVIATION|12.29||0.003|TWO_SIDED|95.0|-9.12|-2.06|||t-test, 2 sided|||Statistical analysis was carried out between categories, Baseline: mental component score and Month 60: mental component score.||-2.06|-9.12|0.003
72612272|NCT00303186|144753317|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.7|STANDARD_DEVIATION|12.8||0.002|TWO_SIDED|95.0|-9.23|-2.18|||t-test, 2 sided|||Statistical analysis was carried out between categories, Month 12: mental component score and Month 60: mental component score.||-2.18|-9.23|0.002
72612273|NCT00267670|144753319|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.0|STANDARD_ERROR_OF_MEAN|1.0||0.46|||||||ANOVA|||Sample size estimates were based on 30% reduction in ALT in the treatment group \& 15% reduction in the placebo group. With a sample size of 30 planned (20 treatment:10 placebo), the study was designed to have a power of 90% to detect a difference in means of 1.25 standard deviations (ES=1.25), \& a power of 80% to detect a difference in means of 1.1 standard deviations (ES=1.1), based on calculations using power index, z-table, \& accounting for unequal sample size: n1 = 20, n2 = 10, a = 0.05.||||0.46
72612274|NCT00267670|144753320|SUPERIORITY_OR_OTHER|||||||0.16||95.0|||||t-test, 2 sided|||Null hypothesis was that there was no difference between mean hepatic expression of TNF-alpha receptors in patient with NASH. This was a secondary outcome and no power analysis was done.||||0.16
72612275|NCT00267670|144753321|SUPERIORITY_OR_OTHER|||||||0.94|||||||t-test, 2 sided|||||||0.94
72612276|NCT00267670|144753322|SUPERIORITY_OR_OTHER|||||||0.49|||||||t-test, 2 sided|||||||0.49
72612277|NCT02326883|144753323|SUPERIORITY||Cox Proportional Hazard|1.07|STANDARD_ERROR_OF_MEAN|0.12||0.61|TWO_SIDED|95.0|0.86|1.33||A priori two-sided comparison of Care Management condition to Usual Care|Log Rank|A priori Bonferonni-corrected threshold for statistical significance was 0.025.|To clarify direction of comparison: relative hazard of suicide attempt among participants assigned to Care Management was 1.07 (95% CI 0.86 - 1.33) higher compared to participants assigned to Usual Care|Comparison of participants assigned to Care Management intervention to those assigned to continued Usual Care||1.33|0.86|0.61
72612278|NCT02326883|144753323|SUPERIORITY|A priori two-sided comparison of Skills Training to usual care.|Cox Proportional Hazard|1.29|STANDARD_ERROR_OF_MEAN|0.14||0.02|TWO_SIDED|95.0|1.05|1.59||A priori Bonferonni-corrected threshold for statistical significance was 0.025.|Log Rank||To clarify direction of comparison: relative hazard of suicide attempt in participants assigned to Skills Training was 1.29 (95% CI 1.05-1.59) times higher than in those assigned to Usual Care|Comparison of Skills Training to Usual Care||1.59|1.05|0.02
72612279|NCT04383132|144753339|OTHER|||||||0.388||||||Independent t-test was used to compare mean CIT between two groups. The statistical significance level was accepted as p\<0.05|t-test, 2 sided|||In sample size calculation, CIT and SD were used. It was found that 326 patients (163 per group) were required to detect a 60-second difference in CIT (SD 192 secs), with 80% power and two-sided alpha 0.05. The frequency of the auxiliary maneuvers was calculated that 324 patients were required for a 20% reduction in the auxiliary maneuvers. In case of becoming lost to follow up and withdrawal, the number of patients was expanded by 5%, and a total of 346 patients, were included in the study.||||0.388
72612280|NCT04383132|144753340|OTHER|||||||0.069||||||For the comparison of ancillary maneuvers Pearson chi-square test, Fisher's exact test, and Fisher-Freeman-Halton exact test were used.|Chi-squared|||||||0.069
72612281|NCT04383132|144753341|OTHER|||||||0.487||||||Independent t-test was used to compare mean CIL between two groups.|t-test, 2 sided|||||||0.487
72612282|NCT04383132|144753342|OTHER|||||||0.822|||||||Chi-squared|||||||0.822
72612283|NCT04383132|144753343|OTHER|||||||0.016|||||||Chi-squared|||||||0.016
72612284|NCT04383132|144753344|OTHER|||||||0.001|||||||t-test, 2 sided|||||||0.001
72612285|NCT04383132|144753345|OTHER|||||||0.184|||||||Fisher Exact|||||||0.184
72612286|NCT04810962|144753368|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
72612287|NCT04810962|144753369|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
72612288|NCT04810962|144753371|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
72612289|NCT04810962|144753372|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
72612290|NCT04810962|144753373|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
72612291|NCT04810962|144753374|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
72612292|NCT04810962|144753375|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
72612293|NCT04810962|144753376|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
72612294|NCT04810962|144753377|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
72612295|NCT04810962|144753378|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
72612296|NCT04810962|144753379|SUPERIORITY||Mean Difference (Net)|-1.2|||<|0.001|TWO_SIDED|95.0|-1.4|-1.0|||ANCOVA||Treatment Difference = APP13007-Placebo. Mean Difference Is the least-squares mean difference from the ANCOVA model with treatment as a fixed effect and baseline as a covariate.|||-1.0|-1.4|<0.001
72612297|NCT04810962|144753380|SUPERIORITY||Mean Difference (Net)|-0.5|||<|0.001|TWO_SIDED|95.0|-0.7|-0.3|||ANCOVA||Treatment Difference = APP13007-Placebo. Mean Difference Is the least-squares mean difference from the ANCOVA model with treatment as a fixed effect and baseline as a covariate.|||-0.3|-0.7|<0.001
72612298|NCT04810962|144753381|SUPERIORITY||Mean Difference (Net)|-0.4|||<|0.001|TWO_SIDED|95.0|-0.5|-0.3|||ANCOVA||Treatment Difference = APP13007-Placebo. Mean Difference Is the least-squares mean difference from the ANCOVA model with treatment as a fixed effect and baseline as a covariate.|||-0.3|-0.5|<0.001
72612299|NCT04810962|144753382|SUPERIORITY||Mean Difference (Net)|-0.05|||<|0.001|TWO_SIDED|95.0|-0.07|-0.02|||ANCOVA||Treatment Difference = APP13007-Placebo. Mean Difference Is the least-squares mean difference from the ANCOVA model with treatment as a fixed effect and baseline as a covariate.|||-0.02|-0.07|<0.001
72612300|NCT04810962|144753383|SUPERIORITY||Mean Difference (Net)|-0.08|||<|0.001|TWO_SIDED|95.0|-0.1|-0.05|||ANCOVA||Treatment Difference = APP13007-Placebo. Mean Difference Is the least-squares mean difference from the ANCOVA model with treatment as a fixed effect and baseline as a covariate.|||-0.05|-0.10|<0.001
72612301|NCT04810962|144753384|SUPERIORITY||Mean Difference (Net)|-0.08|||<|0.001|TWO_SIDED|95.0|-0.11|-0.05|||ANCOVA||Treatment Difference = APP13007-Placebo. Mean Difference Is the least-squares mean difference from the ANCOVA model with treatment as a fixed effect and baseline as a covariate.|||-0.05|-0.11|<0.001
72612302|NCT04810962|144753385|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
72612303|NCT00142415|144753389|OTHER|The maximum tolerated dose (MTD) was determined using a standard 3 + 3 dose-escalation design. The occurrence of DLTs was compared across cohorts.|Maximum tolerated dose (mCi/m^2)|65.0|||||TWO_SIDED|||||||||||||
72612304|NCT03620162|144753400|OTHER|Estimated differences, confidence intervals (CIs), and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percentage|-3.4|||=|0.525|TWO_SIDED|95.0|-13.6|7.0|||Miettinen & Nurminen method|||Difference in Percentage: Erythema(Group 5 vs 1)||7.0|-13.6|= 0.525
72612305|NCT03620162|144753400|OTHER|Estimated differences, CIs, and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percentage|-4.5|||=|0.396|TWO_SIDED|95.0|-14.7|5.8|||Miettinen & Nurminen method|||Difference in Percentage: Erythema(Group 4 vs 1)||5.8|-14.7|= 0.396
72326732|NCT02651116|144176684|SUPERIORITY||Rate Ratio|0.7014|STANDARD_ERROR_OF_MEAN|0.1086||0.022|TWO_SIDED|95.0|0.5178|0.95||P-Value \<=0.05 level was considered significantly better and P-Value lying between 0.05\<p\<=0.1 level was considered marginally significantly better.|Negative Binomial Regression|||Estimated rate ratio (ratio of rate of cough counts per specified duration for DXM HBr to placebo, used in evaluation of this outcome measure), and corresponding 95% CI for DXM HBr versus placebo was obtained from negative binomial model with treatment, study site (pooled), age group, and log-transformed baseline average cough count per hour as factors, with logarithm of the time over which the cough count was evaluated as the offset parameter.||0.9500|0.5178|0.0220
72419253|NCT04186780|144348893|SUPERIORITY|"The differences between Shiitake and placebo groups were analyzed by the Chi-square test, Exact of Fisher test and Student's t-test.~Descriptions of all biochemical and oxidative stress parameters were expressed as mean ± standard deviation. To investigate the differences in biochemical parameters between the groups, Analysis of Variance (ANOVA) with repeated measurements was applied. All results of biochemical parameters and oxidative stress were normalized to logarithmic scale."|Mean Difference (Net)|47.0||||0.0352|TWO_SIDED|95.0||||P \< 0.05 was accepted as statistically significant.|ANOVA||Difference between placebo group and intervention group of T66.|||||0.0352
72419254|NCT02052310|144348904|NON_INFERIORITY|Non-inferiority was established if the 2-sided 95% confidence interval (CI) for the treatment difference in least square (LS) means from MI ANCOVA model between the 2 treatment groups lay entirely above -0.75 g/dL.|LS Mean Difference|0.18|STANDARD_ERROR_OF_MEAN|0.053||0.0005|TWO_SIDED|95.0|0.079|0.287|||ANCOVA|ANCOVA with multiple imputation||Treatment comparison was made using the multiple imputation (MI) strategy by combining the results of analysis of covariance (ANCOVA) model with baseline Hb as a covariate, and treatment, region and cardiovascular/cerebrovascular/thromboembolic medical history (yes vs. no) as factors.||0.287|0.079|0.0005
72419255|NCT02052310|144348905|NON_INFERIORITY|Non-inferiority was established if the lower bound of the 2-sided 95% CI for the treatment difference for the responder rates (roxadustat minus epoetin alfa) calculated based on the Miettinen \& Nurminen approach, adjusting for stratification factors, was greater than -15%.|Responder Rate Difference|3.5|||||TWO_SIDED|95.0|-0.7|7.7||||||For the difference of responder rates between 2 treatment groups, the CI was analyzed from the Miettinen \& Nurminen approach adjusting for randomization stratification factors.||7.7|-0.7|
72419256|NCT02052310|144348906|NON_INFERIORITY|Non-inferiority was established if the lower bound of the 2-sided 95% CI for the treatment difference for the responder rates (roxadustat minus epoetin alfa) calculated based on the Miettinen \& Nurminen approach, adjusting for stratification factors, was greater than -15%.|Responder Rate Difference|4.3|||||TWO_SIDED|95.0|-0.1|8.7||||||For the difference of responder rates between 2 treatment groups, the CI analyzed was from the Miettinen \& Nurminen approach adjusting for randomization stratification factors.||8.7|-0.1|
72612306|NCT03620162|144753400|OTHER|Estimated differences, CIs, and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percentage|-8.7|||=|0.097|TWO_SIDED|95.0|-18.8|1.6|||Miettinen & Nurminen method|||Difference in Percentage: Erythema(Group 3 vs 1)||1.6|-18.8|= 0.097
72612307|NCT03620162|144753400|OTHER|Estimated differences, CIs, and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percentage|-9.9|||=|0.057|TWO_SIDED|95.0|-19.9|0.3|||Miettinen & Nurminen method|||Difference in Percentage: Erythema(Group 2 vs 1)||0.3|-19.9|= 0.057
72612308|NCT03620162|144753400|OTHER|Estimated differences, CIs, and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percentage|-8.4|||=|0.085|TWO_SIDED|95.0|-17.8|1.2|||Miettinen & Nurminen method|||Difference in Percentage: Induration(Group 5 vs 1)||1.2|-17.8|= 0.085
72612309|NCT03620162|144753400|OTHER|Estimated differences, CIs, and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percentage|-9.5|||=|0.05|TWO_SIDED|95.0|-18.9|0.0|||Miettinen & Nurminen method|||Difference in Percentage: Induration(Group 4 vs 1)||-0.0|-18.9|= 0.050
72326733|NCT02651116|144176685|SUPERIORITY||Rate Ratio|0.7454|STANDARD_ERROR_OF_MEAN|0.0848||0.0098|TWO_SIDED|95.0|0.5964|0.9316||P-Value \<=0.05 level was considered significantly better and P-Value lying between 0.05\<p\<=0.1 level was considered marginally significantly better.|Negative Binomial Regression|||Estimated rate ratio (ratio of rate of cough counts per specified duration for DXM HBr to placebo, used in evaluation of this outcome measure), and corresponding 95% CI for DXM HBr versus placebo was obtained from negative binomial model with treatment, study site (pooled), age group, and log-transformed baseline average cough count per hour as factors, with logarithm of the time over which the cough count was evaluated as the offset parameter.||0.9316|0.5964|0.0098
72326734|NCT02651116|144176686|SUPERIORITY||Difference in least squares mean|-0.221|STANDARD_ERROR_OF_MEAN|0.1324||0.0977|TWO_SIDED|95.0|-0.4831|0.0411||P-Value \<=0.05 level was considered significantly better and P-Value lying between 0.05\<p\<=0.1 level was considered marginally significantly better.|ANCOVA|||Analysis of covariance (ANCOVA) model contained treatment, study site (pooled), log-transformed baseline cough time and age group terms as factors.||0.0411|-0.4831|0.0977
72326735|NCT02651116|144176687|SUPERIORITY||Difference in least squares mean|-0.2881|STANDARD_ERROR_OF_MEAN|0.1224||0.0191|TWO_SIDED|95.0|-0.5287|-0.0475||P-Value \<=0.05 level was considered significantly better and P-Value lying between 0.05\<p\<=0.1 level was considered marginally significantly better.|ANOVA|||Analysis of variance (ANOVA) model contained treatment, study site (pooled), the corresponding morning baseline cough frequency by participant, and age group included in the model. The statistical analysis was performed on the composite for all categories.||-0.0475|-0.5287|0.0191
72326736|NCT02651116|144176687|SUPERIORITY|||||||0.8355||||||P-value is for interaction term of treatment by age group. P-value \<=0.10 was considered significant for interaction terms.|ANOVA|||ANOVA model contained treatment, study site (pooled), screening assessment by participant, interaction of treatment by age group and age group included in the model.||||0.8355
72326737|NCT02651116|144176688|SUPERIORITY||Difference in least squares mean|-0.3128|STANDARD_ERROR_OF_MEAN|0.1104||0.0049|TWO_SIDED|95.0|-0.5299|-0.0956||P-Value \<=0.05 level was considered significantly better and P-Value lying between 0.05\<p\<=0.1 level was considered marginally significantly better.|ANOVA|||ANOVA model contained treatment, study site (pooled), the corresponding morning baseline cough severity by participant, and age group included in the model. The statistical analysis was performed on the composite for all categories.||-0.0956|-0.5299|0.0049
72326738|NCT02651116|144176688|SUPERIORITY|||||||0.8413||||||P-value is for interaction term of treatment by age group. P-value \<=0.10 was considered significant for interaction terms.|ANOVA|||ANOVA model contained treatment, study site (pooled), screening assessment by participant, interaction of treatment by age group and age group included in the model.||||0.8413
72326739|NCT02651116|144176689|SUPERIORITY||Difference in least squares mean|-0.1483|STANDARD_ERROR_OF_MEAN|0.1337||0.2679|TWO_SIDED|95.0|-0.4112|0.1146||P-Value \<=0.05 level was considered significantly better and P-Value lying between 0.05\<p\<=0.1 level was considered marginally significantly better.|ANOVA|||ANOVA model contained treatment, study site (pooled), the corresponding morning baseline impact on sleep by participant, and age group included in the model. The statistical analysis was performed on the composite for all categories.||0.1146|-0.4112|0.2679
72326740|NCT02651116|144176689|SUPERIORITY|||||||0.2882||||||P-value is for interaction term of treatment by age group. P-value \<=0.10 was considered significant for interaction terms.|ANOVA|||ANOVA model contained treatment, study site (pooled), screening assessment by participant, interaction of treatment by age group and age group included in the model.||||0.2882
72326741|NCT02651116|144176690|SUPERIORITY||Difference in least squares mean|-0.2812|STANDARD_ERROR_OF_MEAN|0.1242||0.0242|TWO_SIDED|95.0|-0.5255|-0.0369||P-Value \<=0.05 level was considered significantly better and P-Value lying between 0.05\<p\<=0.1 level was considered marginally significantly better.|ANOVA|||ANOVA model contained treatment, study site (pooled), the corresponding afternoon baseline cough frequency by participant, and age group included in the model. The statistical analysis was performed on the composite for all categories.||-0.0369|-0.5255|0.0242
72326742|NCT02651116|144176690|SUPERIORITY|||||||0.2892||||||P-value is for interaction term of treatment by age group. P-value \<=0.10 was considered significant for interaction terms.|ANOVA|||ANOVA model contained treatment, study site (pooled), afternoon baseline assessment by participant, interaction of treatment by age group and age group included in the model.||||0.2892
72326743|NCT02651116|144176691|SUPERIORITY||Difference in least squares mean|-0.3014|STANDARD_ERROR_OF_MEAN|0.1096||0.0063|TWO_SIDED|95.0|-0.517|-0.0858||P-Value \<=0.05 level was considered significantly better and P-Value lying between 0.05\<p\<=0.1 level was considered marginally significantly better.|ANOVA|||ANOVA model contained treatment, study site (pooled), the corresponding afternoon baseline cough severity by participant, and age group included in the model. The statistical analysis was performed on the composite for all categories.||-0.0858|-0.5170|0.0063
72326744|NCT02651116|144176691|SUPERIORITY|||||||0.3268||||||P-value is for interaction term of treatment by age group. P-value \<=0.10 was considered significant for interaction terms.|ANOVA|||ANOVA model contained treatment, study site (pooled), afternoon baseline assessment by participant, interaction of treatment by age group and age group included in the model.||||0.3268
72326745|NCT02651116|144176692|SUPERIORITY||Difference in least squares mean|-0.2535|STANDARD_ERROR_OF_MEAN|0.1124||0.0247|TWO_SIDED|95.0|-0.4745|-0.0325||P-Value \<=0.05 level was considered significantly better and P-Value lying between 0.05\<p\<=0.1 level was considered marginally significantly better.|ANOVA|||ANOVA model with treatment, study site (pooled), the baseline assessment in child global question cold assessment by participant and age group included in the model. The statistical analysis was performed on the composite for all categories.||-0.0325|-0.4745|0.0247
72326746|NCT02651116|144176692|SUPERIORITY|||||||0.4093||||||P-value is for interaction term of treatment by age group. P-value \<=0.10 was considered significant for interaction terms.|ANOVA|||ANOVA model with treatment, study site (pooled), baseline assessment by participant, interaction of treatment by age group and age group included in the model.||||0.4093
72612310|NCT03620162|144753400|OTHER|Estimated differences, CIs, and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percentage|-6.5|||=|0.183|TWO_SIDED|95.0|-16.1|3.1|||Miettinen & Nurminen method|||Difference in Percentage: Induration(Group 3 vs 1)||3.1|-16.1|= 0.183
72326747|NCT02651116|144176693|SUPERIORITY||Difference in least squares mean|0.1266|STANDARD_ERROR_OF_MEAN|0.2196||0.5652|TWO_SIDED|95.0|-0.3081|0.5614||P-Value \<=0.05 level was considered significantly better and P-Value lying between 0.05\<p\<=0.1 level was considered marginally significantly better.|ANOVA|||Participant: ANOVA model with treatment, study site (pooled), and age group included in the model.||0.5614|-0.3081|0.5652
72326748|NCT02651116|144176693|SUPERIORITY||Difference in least squares mean|-0.1368|STANDARD_ERROR_OF_MEAN|0.1982||0.4914|TWO_SIDED|95.0|-0.5292|0.2556||P-Value \<=0.05 level was considered significantly better and P-Value lying between 0.05\<p\<=0.1 level was considered marginally significantly better.|ANOVA|||Caregiver: ANOVA model with treatment, study site (pooled), and age group included in the model.||0.2556|-0.5292|0.4914
72326749|NCT02651116|144176693|SUPERIORITY|||||||0.1029||||||P-value is for interaction term of treatment by age group. P-value \<=0.10 was considered significant for interaction terms.|ANOVA|||Participant: ANOVA model with treatment, study site (pooled), interaction of treatment by age group and age group included in the model.||||0.1029
72326750|NCT02651116|144176693|SUPERIORITY|||||||0.4736||||||P-value is for interaction term of treatment by age group. P-value \<=0.10 was considered significant for interaction terms.|ANOVA|||Caregiver: ANOVA model with treatment, study site (pooled), interaction of treatment by age group and age group included in the model.||||0.4736
72326751|NCT02379052|144176715|SUPERIORITY||Least Squares (LS) Mean Difference|-1.7||||0.0304|TWO_SIDED|95.0|-3.22|-0.16|||ANCOVA|A 2-step multiple imputation (MI) method addressed missing values (\[seeds = 12345 \& 54321 in the 2 steps respectively; number of imputations=50\]).|The confidence interval (CI) with p-value is based on treatment difference (dupilumab vs. placebo) of the LS mean using analysis of covariance (ANCOVA) model with baseline measurement as covariate and the treatment as fixed factor.|||-0.16|-3.22|0.0304
72326752|NCT02379052|144176716|SUPERIORITY||Least Squares Mean Difference|-26.45||||0.0312|TWO_SIDED|95.0|-50.523|-2.387|||ANCOVA|A 2-step multiple imputation (MI) method addressed missing values (\[seeds = 12345 \& 54321 in the 2 steps respectively; number of imputations=50\]).|The confidence interval (CI) with p-value is based on treatment difference (dupilumab vs. placebo) of the LS mean using analysis of covariance (ANCOVA) model with baseline measurement as covariate and the treatment as fixed factor.|||-2.387|-50.523|0.0312
72326753|NCT02379052|144176717|SUPERIORITY||Least Squares Mean Difference|-0.8||||0.383|TWO_SIDED|95.0|-2.48|0.96|||ANCOVA|A 2-step multiple imputation (MI) method addressed missing values (\[seeds = 12345 \& 54321 in the 2 steps respectively; number of imputations=50\]).|The confidence interval (CI) with p-value is based on treatment difference (dupilumab vs. placebo) of the LS mean using analysis of covariance (ANCOVA) model with baseline measurement as covariate and the treatment as fixed factor.|||0.96|-2.48|0.3830
72612311|NCT03620162|144753400|OTHER|Estimated differences, CIs, and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percentage|-8.7|||=|0.074|TWO_SIDED|95.0|-18.1|0.8|||Miettinen & Nurminen method|||Difference in Percentage: Induration(Group 2 vs 1)||0.8|-18.1|= 0.074
72612312|NCT03620162|144753400|OTHER|Estimated differences, CIs, and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percentage|3.4|||=|0.525|TWO_SIDED|95.0|-7.0|13.6|||Miettinen & Nurminen method|||Difference in Percentage: Tenderness(Group 5 vs 1)||13.6|-7.0|= 0.525
72326754|NCT02379052|144176718|SUPERIORITY||Least Squares Mean Difference|-11.0||||0.4147|TWO_SIDED|95.0|-37.46|15.467|||ANCOVA|A 2-step multiple imputation (MI) method addressed missing values (\[seeds = 12345 \& 54321 in the 2 steps respectively; number of imputations=50\]).|The confidence interval (CI) with p-value is based on treatment difference (dupilumab vs. placebo) of the LS mean using analysis of covariance (ANCOVA) model with baseline measurement as covariate and the treatment as fixed factor.|||15.467|-37.460|0.4147
72326755|NCT02379052|144176719|SUPERIORITY||Percent Difference|26.6||||0.049|TWO_SIDED|95.0|-3.04|51.05|||Clopper-Pearson Exact||Difference is Dupilumab minus Placebo. CI = Confidence interval calculated using Clopper-Pearson Exact method|||51.05|-3.04|0.0490
72326756|NCT02379052|144176720|SUPERIORITY||Percent Difference|26.6||||0.049|TWO_SIDED|95.0|-3.04|51.05|||Clopper-Pearson Exact||Difference is Dupilumab minus Placebo. CI = Confidence interval calculated using Clopper-Pearson Exact method|||51.05|-3.04|0.0490
72326757|NCT02379052|144176721|SUPERIORITY||Least Squares Mean Difference|-23.23||||0.085|TWO_SIDED|95.0|-49.677|3.212|||ANCOVA|A 2-step multiple imputation (MI) method addressed missing values (\[seeds = 12345 \& 54321 in the 2 steps respectively; number of imputations=50\]).|The confidence interval (CI) with p-value is based on treatment difference (dupilumab vs. placebo) of the LS mean using analysis of covariance (ANCOVA) model with baseline measurement as covariate and the treatment as fixed factor.|||3.212|-49.677|0.0850
72326758|NCT02379052|144176722|SUPERIORITY||Least Squares Mean Difference|-13.9||||0.0635|TWO_SIDED|95.0|-28.54|0.78|||ANCOVA|A 2-step multiple imputation (MI) method addressed missing values (\[seeds = 12345 \& 54321 in the 2 steps respectively; number of imputations=50\]).|The confidence interval (CI) with p-value is based on treatment difference (dupilumab vs. placebo) of the LS mean using ANCOVA model with baseline measurement and baseline SDI score as covariates and the treatment as fixed factor.|||0.78|-28.54|0.0635
72326759|NCT02379052|144176723|SUPERIORITY||Least Squares Mean Difference|-33.65||||0.0608|TWO_SIDED|95.0|-68.828|1.536|||ANCOVA|A 2-step multiple imputation (MI) method addressed missing values (\[seeds = 12345 \& 54321 in the 2 steps respectively; number of imputations=50\])|The confidence interval (CI) with p-value is based on treatment difference (dupilumab vs. placebo) of the LS mean using ANCOVA model with baseline measurement and baseline SDI score as covariates and the treatment as fixed factor.|||1.536|-68.828|0.0608
72612313|NCT03620162|144753400|OTHER|Estimated differences, CIs, and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percentage|-0.6|||=|0.915|TWO_SIDED|95.0|-10.8|9.7|||Miettinen & Nurminen method|||Difference in Percentage: Tenderness(Group 4 vs 1)||9.7|-10.8|= 0.915
72419257|NCT02052310|144348907|NON_INFERIORITY|Non-inferiority was established if the 2-sided 95% CI for the treatment difference in LS means of change from baseline Hb averaged over Weeks 28 to 52 lay entirely above -0.75 g/dL.|LS Mean Difference|0.16|STANDARD_ERROR_OF_MEAN|0.067||0.0148|TWO_SIDED|95.0|0.032|0.296|||Mixed Models Analysis|||Treatment comparison was made using mixed model for repeated measures (MMRM) with baseline Hb as a covariate, and treatment, visit, visit-by-treatment interaction and randomization stratification factors except mean qualifying screening hemoglobin (≤8.0 vs. \>8.0 g/dL) as fixed effects.||0.296|0.032|0.0148
72419258|NCT02052310|144348908|SUPERIORITY|Superiority was declared if the upper bound of the 2-sided 95% CI of the difference between roxadustat and epoetin alfa (roxadustat - epoetin alpha) was less than 0.|LS Mean Difference|-18.34|STANDARD_ERROR_OF_MEAN|1.584|<|0.0001|TWO_SIDED|95.0|-21.448|-15.232|||Mixed Models Analysis|||Treatment comparison was made using a MMRM with baseline LDL cholesterol as a covariate, and treatment, visit, visit-by-treatment interaction and randomization stratification factors as fixed effects.||-15.232|-21.448|<0.0001
72419259|NCT02052310|144348909|NON_INFERIORITY|The non-inferiority margin was fixed as a difference of -0.75.|LS Mean Difference|0.02|STANDARD_ERROR_OF_MEAN|0.099||0.8178|TWO_SIDED|95.0|-0.171|0.217|||ANCOVA|ANCOVA multiple imputation||Treatment comparison was made using the multiple imputation strategy by combining the results of ANCOVA model with baseline Hb as a covariate, and treatment, region and cardiovascular/cerebrovascular/thromboembolic medical history (yes vs. no) as factors.||0.217|-0.171|0.8178
72419260|NCT02052310|144348910|SUPERIORITY|||||||0.00028||||||Threshold for significance at 0.05 level.|Rank ANCOVA|||Treatment comparison was made using an ANCOVA model with baseline iron repletion status, treatment, and randomization stratification factors as fixed effects.||||0.00028
72612314|NCT03620162|144753400|OTHER|Estimated differences, CIs, and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percentage|1.9|||=|0.714|TWO_SIDED|95.0|-8.4|12.2|||Miettinen & Nurminen method|||Difference in Percentage: Tenderness(Group 3 vs 1)||12.2|-8.4|= 0.714
72612315|NCT03620162|144753400|OTHER|Estimated differences, CIs, and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percentage|-0.5|||=|0.926|TWO_SIDED|95.0|-10.7|9.7|||Miettinen & Nurminen method|||Difference in Percentage: Tenderness(Group 2 vs 1)||9.7|-10.7|= 0.926
72419261|NCT02052310|144348911|NON_INFERIORITY|The non-inferiority margin for the difference between groups was 1.8.|Hazard Ratio (HR)|1.26||||0.3284|TWO_SIDED|95.0|0.791|2.016|||Cox Proportional Hazards model|||Analysis was done using a Cox Proportional Hazards model adjusting for baseline Hb and other stratification factors except mean qualifying screening hemoglobin (\<= 8.0 vs. \>8.0 g/dL) as fixed effects.||2.016|0.791|0.3284
72419262|NCT02066402|144348922|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority (NI) hypothesis test is a 1-sided hypothesis test performed at the 2.5% level of significance. Predefined margin for non-inferiority is -10%.|Difference of responder rate|-4.6||||0.2027|TWO_SIDED|95.0|-11.2|2.2|||Fisher Exact|||||2.2|-11.2|0.2027
72612316|NCT03620162|144753400|OTHER|Estimated differences, CIs, and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percentage|0.0|||>|0.999|TWO_SIDED|95.0|-8.7|8.7|||Miettinen & Nurminen method|||Difference in Percentage: Swelling(Group 5 vs 1)||8.7|-8.7|> 0.999
72612317|NCT03620162|144753400|OTHER|Estimated differences, CIs, and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percentage|-2.2|||=|0.609|TWO_SIDED|95.0|-10.8|6.4|||Miettinen & Nurminen method|||Difference in Percentage: Swelling(Group 4 vs 1)||6.4|-10.8|= 0.609
72419263|NCT02066402|144348923|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority (NI) hypothesis test is a 1-sided hypothesis test performed at the 2.5% level of significance.|Difference of responder rate|-2.2|||||TWO_SIDED|95.0|-8.3|3.8||||||||3.8|-8.3|
72419264|NCT02066402|144348924|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority (NI) hypothesis test is a 1-sided hypothesis test performed at the 2.5% level of significance.|Difference of responder rate|-2.1|||||TWO_SIDED|95.0|-7.4|3.2||||||||3.2|-7.4|
72419265|NCT02066402|144348925|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority (NI) hypothesis test is a 1-sided hypothesis test performed at the 2.5% level of significance.|Difference of responder rate|-2.2|||||TWO_SIDED|95.0|-8.6|4.1||||||||4.1|-8.6|
72419266|NCT02066402|144348926|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority (NI) hypothesis test is a 1-sided hypothesis test performed at the 2.5% level of significance.|Difference of responder rate|-3.1|||||TWO_SIDED|95.0|-8.4|2.0||||||||2.0|-8.4|
72419267|NCT01755702|144348938|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.25||||0.284|TWO_SIDED|95.0|0.83|1.9|||Cox Proportional Hazard Model|||Null hypothesis considered no difference between the treatments in comparison.||1.90|0.83|0.2840
72419268|NCT01755702|144348938|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.32||||0.2008|TWO_SIDED|95.0|0.86|2.01|||Cox Proportional Hazard Model|||Null hypothesis considered no difference between the treatments in comparison.||2.01|0.86|0.2008
72419269|NCT01755702|144348938|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.17||||0.4552|TWO_SIDED|95.0|0.78|1.74|||Cox Proportional Hazard Model|||Null hypothesis considered no difference between the treatments in comparison.||1.74|0.78|0.4552
72419270|NCT01755702|144348938|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.13||||0.5579|TWO_SIDED|95.0|0.75|1.71|||Cox Proportional Hazard Model|||||1.71|0.75|0.5579
72419271|NCT01755702|144348938|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.08||||0.7214|TWO_SIDED|95.0|0.72|1.61|||Cox Proportional Hazard Model|||Null hypothesis considered no difference between the treatments in comparison.||1.61|0.72|0.7214
72419272|NCT01755702|144348938|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.95||||0.8192|TWO_SIDED|95.0|0.62|1.45|||Cox Proportional Hazard Model|||Null hypothesis considered no difference between the treatments in comparison.||1.45|0.62|0.8192
72419273|NCT03786952|144348967|SUPERIORITY|||||||0.453|||||||ANOVA|||||||0.453
72419274|NCT03786952|144348968|SUPERIORITY|||||||0.931|||||||ANOVA|||||||0.931
72419275|NCT03786952|144348969|SUPERIORITY|||||||0.923|||||||ANOVA|||||||0.923
72419276|NCT03786952|144348970|SUPERIORITY|||||||0.399|||||||ANOVA|||||||0.399
72419277|NCT03786952|144348971|SUPERIORITY|||||||0.872|||||||ANOVA|||||||0.872
72419278|NCT03786952|144348972|SUPERIORITY|||||||0.998|||||||ANOVA|||||||0.998
72612318|NCT03620162|144753400|OTHER|Estimated differences, CIs, and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percentage|1.8|||=|0.688|TWO_SIDED|95.0|-7.1|10.7|||Miettinen & Nurminen method|||Difference in Percentage: Swelling(Group 3 vs 1)||10.7|-7.1|= 0.688
72326760|NCT02379052|144176724|SUPERIORITY||Least Squares Mean Difference|-21.1||||0.0318|TWO_SIDED|95.0|-40.42|-1.86|||ANCOVA|A 2-step multiple imputation (MI) method addressed missing values (\[seeds = 12345 \& 54321 in the 2 steps respectively; number of imputations=50\]).|The confidence interval (CI) with p-value is based on treatment difference (dupilumab vs. placebo) of the LS mean using ANCOVA model with baseline measurement and baseline SDI score as covariates and the treatment as fixed factor.|||-1.86|-40.42|0.0318
72326761|NCT02379052|144176725|SUPERIORITY||Percent Difference|17.8||||0.1365|TWO_SIDED|95.0|-11.54|43.55||P-values were derived by Fisher exact test|Clopper-Pearson Exact|CI = Confidence interval calculated using Exact method|Difference is Dupilumab minus Placebo|||43.55|-11.54|0.1365
72326762|NCT02379052|144176726|SUPERIORITY||Percent Difference|35.0||||0.0044|TWO_SIDED|95.0|5.69|58.34||P-values were derived by Fisher exact test|Clopper-Pearson Exact|CI = Confidence interval calculated using Exact method|Difference is Dupilumab minus Placebo|||58.34|5.69|0.0044
72326763|NCT02379052|144176727|SUPERIORITY||Least Squares Mean Difference|-107.13|||<|0.0001|TWO_SIDED|95.0|-141.215|-73.046|||ANCOVA|A 2-step multiple imputation (MI) method addressed missing values (\[seeds = 12345 \& 54321 in the 2 steps respectively; number of imputations=50\])|The confidence interval (CI) with p-value is based on treatment difference (dupilumab vs. placebo) of the LS mean using ANCOVA model with baseline measurement and baseline SDI score as covariates and the treatment as fixed factor.|||-73.046|-141.215|<0.0001
72326764|NCT02379052|144176728|SUPERIORITY||Least Square Mean Difference|-1.6||||0.0006|TWO_SIDED|95.0|-2.5|-0.68|||ANCOVA|A 2-step multiple imputation (MI) method addressed missing values (\[seeds = 12345 \& 54321 in the 2 steps respectively; number of imputations=50\])|The confidence interval (CI) with p-value is based on treatment difference (dupilumab vs. placebo) of the LS mean using ANCOVA model with baseline measurement and baseline SDI score as covariates and the treatment as fixed factor.|||-0.68|-2.50|0.0006
72326765|NCT02379052|144176729|SUPERIORITY||Least Squares Mean Difference|0.33||||0.091|TWO_SIDED|95.0|-0.053|0.72|||ANCOVA|A 2-step multiple imputation (MI) method addressed missing values (\[seeds = 12345 \& 54321 in the 2 steps respectively; number of imputations=50\]).|The confidence interval (CI) with p-value is based on treatment difference (dupilumab vs. placebo) of the LS mean using ANCOVA model with baseline measurement and baseline SDI score as covariates and the treatment as fixed factor.|||0.720|-0.053|0.0910
72612319|NCT03620162|144753400|OTHER|Estimated differences, CIs, and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percentage|-4.1|||=|0.336|TWO_SIDED|95.0|-12.6|4.3|||Miettinen & Nurminen method|||Difference in Percentage: Swelling(Group 2 vs 1)||4.3|-12.6|= 0.336
72612320|NCT03620162|144753401|OTHER|Estimated differences, CIs, and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percentage|-1.1|||=|0.825|TWO_SIDED|95.0|-11.0|8.8|||Miettinen & Nurminen method|||Difference in Percentage:Appetite lost(Group5 vs1)||8.8|-11.0|= 0.825
72326766|NCT02655887|144176782|NON_INFERIORITY|PG of 74%, which was set at 10% (non-inferiority margin) below the weighted mean of primary patency (PP2) rate at 12 month at a combination of 55% (PTS) subjects at primary patency rate of 77.1% and 45% (NIVL) subjects at primary patency rate of 93.4%. When taking into consideration both co-primary efficacy and safety endpoints, with 138 BVS subjects, the overall study power is at least 85%\*99%=84%.|Weighted Z-statistics|88.3||||0.0001|ONE_SIDED|90.0|82.4||||Weighted Z-statistics|||"Hypothesis: H0 :Primary patency rate at 12 months post-index procedure from the overall VENOVO Venous Stent (BVS) patients (PTS and NIVL combined) is at most as good as that of the PG.~Ha: Primary patency rate at 12 months post-index procedure from the overall VENOVO Venous Stent (BVS) patients (PTS and NIVL combined) is better than that of PG."|||82.4|0.0001
72326767|NCT02655887|144176783|NON_INFERIORITY|The primary safety endpoint was evaluated against the PG of 89% which was set at 10% (non-inferiority margin) below the literature-derived average freedom from MAE rate at 30 day of 99%. A one-side p-value is derived based on an exact binomial test. When taking into consideration both co-primary efficacy and safety endpoints, with 138 BVS subjects, the overall study power is at least 85%\*99%=84%.|Exact binomial test|93.5||||0.0322|ONE_SIDED|90.0|89.5||||Exact binomial test|||"Hypothesis: H0: The primary safety endpoint absence from event rate in the VENOVO Venous Stent (BVS) through 30 day at most as large as that of the PG.~Ha: The primary safety endpoint absence from event rate in the VENOVO Venous Stent (BVS) through 30 day is better than that of the PG."|||89.5|0.0322
72326768|NCT02655887|144176784|OTHER|||||||0.001||||||this p value is \< 0.001.|t-test, 2 sided|||"H0: The distribution at the 12-month follow-up remains unimproved compared to baseline.~Ha: The distribution shifts toward lower (less pain) classes."||||0.001
72326769|NCT02655887|144176785|OTHER|||||||0.001||||||p value is \< 0.001|t-test, 2 sided|||||||0.001
72326770|NCT00532844|144176834|SUPERIORITY||Geometric Mean Ratio|1.5|||<|0.001|TWO_SIDED|95.0|1.2|1.8||The model will constitute the independent variables of treatment regimen, treatment sequence, and period as fixed effects, and subject as a random effect. The dependent variable plasma BH4 concentration (AUC0-12 hr) expressed in log transformation.|Mixed Models Analysis|||To determine if administration of saproprterin dihydrochloride administered with Vitamin C results in higher plasma BH4 concentrations when compared with administration of sapropterin dihydrochloride alone in subjects with endothelial dysfunction. The difference in the plasma BH4 concentration (AUC0-12 hr) between the 2 regimens will be compared using a mixed model with a 0.05 level of significance. The difference is represented as the geometric mean ratio.||1.8|1.2|<0.001
72419279|NCT03786952|144348973|SUPERIORITY|||||||0.1|||||||ANOVA|||||||0.10
72419280|NCT03786952|144348974|SUPERIORITY|||||||0.992|||||||ANOVA|||||||0.992
72419281|NCT03786952|144348975|SUPERIORITY|||||||0.519|||||||ANOVA|||||||0.519
72419282|NCT03786952|144348976|SUPERIORITY|||||||0.007|||||||ANOVA|||||||0.007
72419283|NCT03786952|144348977|SUPERIORITY|||||||0.457|||||||ANOVA|||||||0.457
72419284|NCT03786952|144348978|SUPERIORITY|||||||0.415|||||||ANOVA|||||||0.415
72419285|NCT03786952|144348979|SUPERIORITY|||||||0.923|||||||ANOVA|||||||0.923
72419286|NCT03786952|144348980|SUPERIORITY|||||||0.981|||||||ANOVA|||||||0.981
72419287|NCT03786952|144348981|SUPERIORITY|||||||0.627|||||||ANOVA|||||||0.627
72419288|NCT03786952|144348982|SUPERIORITY|||||||0.901|||||||ANOVA|||||||0.901
72419289|NCT03786952|144348983|SUPERIORITY|||||||0.166|||||||ANOVA|||||||0.166
72419290|NCT03786952|144348984|SUPERIORITY|||||||0.252|||||||ANOVA|||||||0.252
72419291|NCT02152982|144348993|SUPERIORITY|||||||0.1462|||||||Log Rank|||||||0.1462
72419292|NCT02152982|144348994|SUPERIORITY||Cox Proportional Hazard|1.02||||0.9101|TWO_SIDED|95.0|0.7|1.5|||Type 3 likelihood-ratio p-value|||||1.50|0.70|0.9101
72419293|NCT02152982|144348995|SUPERIORITY||Cox Proportional Hazard|1.05||||0.3059|TWO_SIDED|95.0|0.86|1.29|||Log Rank|||||1.29|0.86|0.3059
72419294|NCT02152982|144348996|SUPERIORITY|||||||0.6827|||||||Chi-squared|||||||0.6827
72419295|NCT02152982|144348997|SUPERIORITY||||||<|0.0001|||||||Chi-squared|||||||<0.0001
72419296|NCT00762450|144349003|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANOVA|paired t-tests||The null hypothesis states that there is no difference between groups.||||0.05
72419297|NCT03905330|144349004|SUPERIORITY||Least-Square mean|-1.089|STANDARD_ERROR_OF_MEAN|0.3691|=|0.0063|TWO_SIDED|95.0|-1.845|-0.334|||Mixed Models Analysis|||The difference between maralixibat and placebo treatment groups in the mean change in the average ItchRO(Obs) severity score between baseline and Weeks 15-26||-0.334|-1.845|= 0.0063
72419298|NCT03905330|144349005|SUPERIORITY||Least-Square mean|-186.723|STANDARD_ERROR_OF_MEAN|51.9501|=|0.0013|TWO_SIDED|95.0|-293.454|-79.992|||Mixed Models Analysis|||||-79.992|-293.454|= 0.0013
72419299|NCT03905330|144349006|SUPERIORITY||Least-Square mean|-1.2|STANDARD_ERROR_OF_MEAN|0.263|<|0.0001|TWO_SIDED|95.0|-1.727|-0.674|||Mixed Models Analysis|||||-0.674|-1.727|< 0.0001
72419300|NCT03905330|144349007|SUPERIORITY||Least-Square mean|-160.403|STANDARD_ERROR_OF_MEAN|30.1827|<|0.0001|TWO_SIDED|95.0|-220.836|-99.97|||Mixed Models Analysis|||||-99.970|-220.836|< 0.0001
72419301|NCT03905330|144349008|OTHER||||||=|0.0736|||||||Bernard's exact test|||||||= 0.0736
72419302|NCT03905330|144349009|SUPERIORITY||||||=|0.041|||||||Bernard's exact test|||||||= 0.0410
72419303|NCT03905330|144349010|SUPERIORITY||||||=|0.0023|||||||Bernard's exact test|||||||= 0.0023
72419304|NCT03905330|144349011|SUPERIORITY||||||=|0.0004|||||||Bernard's exact test|||||||= 0.0004
72419305|NCT02782169|144349012|SUPERIORITY|||||||0.32|||||||t-test, 2 sided|||||||0.32
72419306|NCT02953938|144349038|SUPERIORITY||Mean Difference (Net)|-0.21|STANDARD_DEVIATION|0.64||0.368|TWO_SIDED|95.0|-1.49|1.07|||Cochran-Mantel-Haenszel|||||1.07|-1.49|0.3680
72419307|NCT02953938|144349039|SUPERIORITY||Mean Difference (Final Values)|-6.58|STANDARD_DEVIATION|3.042||0.0349|TWO_SIDED|95.0|-12.67|-0.48|||ANOVA|||||-0.48|-12.67|0.0349
72419308|NCT02953938|144349040|SUPERIORITY||Mean Difference (Final Values)|0.06|STANDARD_DEVIATION|0.051||0.2707|TWO_SIDED|95.0|-0.045|0.158|||ANOVA|||||0.158|-0.045|0.2707
72419309|NCT02953938|144349042|SUPERIORITY||Mean Difference (Final Values)|11.32||||0.7602|TWO_SIDED|95.0|-62.65|85.28|||ANOVA|||||85.28|-62.65|0.7602
72419310|NCT02038894|144349043|NON_INFERIORITY|A previous study for evaluating respiratory complications with intubated and insufflated techniques found a difference in the incidence of respiratory complications of 9.1%, a power analysis was determined. 200 subjects per group was estimated provide 82% power to detect a difference. We elected to do an interim analysis when 60 children per group were recruited because of a clinical impression that one of the techniques had a grossly divergent incidence of respiratory complications.|Odds Ratio (OR)|0.0|||<|0.0001|TWO_SIDED|95.0|0.0|0.14||Threshold for significance \<0.05 Comparing SPO2 \<95%|Mean equality test|||||0.14|0|<0.0001
72419311|NCT02038894|144349043|NON_INFERIORITY|A previous study found an incidence of respiratory complications of 9.1%. 200 subjects per group was estimated provide 82% power to detect a difference when conducting a two- sided test at a significance level of a = 0.05.We did an interim analysis when 60 children per group were recruited because of a clinical impression that one of the techniques had a grossly divergent incidence of respiratory complications. Based on the results of that interim analysis, recruitment was discontinued|Odds Ratio (OR)|0.0||||0.0001|TWO_SIDED|95.0|0.0|0.27||p\<0.05. Sp02\<85%|Mean equality test||Odds ratios were calculated to the respiratory complications comparing the different groups and by regrouping by the differences in airway management (IS + IP vs NA) and by the medication used for anesthesia maintenance (IS vs IP + NA)|||0.27|0|0.0001
72419312|NCT02038894|144349044|NON_INFERIORITY|No previous data was available to calculate a power calculation for the secondary outcome.||||||0.901||||||Threshold of Significance|Mean equality test|||Total OR Time||||0.901
72419313|NCT03848403|144349058|SUPERIORITY||Least Squares (LS) Means Difference|-21.69|||<|0.0001|TWO_SIDED|95.0|-26.9|-16.48|||Mixed Models Analysis|||||-16.48|-26.90|<0.0001
72419314|NCT03848403|144349058|SUPERIORITY||LS Means Difference|-21.14|||<|0.0001|TWO_SIDED|95.0|-26.39|-15.88|||Mixed Models Analysis|||||-15.88|-26.39|<0.0001
72419315|NCT03848403|144349058|SUPERIORITY||LS Means Difference|0.55||||0.8341|TWO_SIDED|95.0|-4.65|5.75|||Mixed Models Analysis|||||5.75|-4.65|0.8341
72419316|NCT01939548|144349060|SUPERIORITY_OR_OTHER||Least Squares Mean (LSM) Difference|3.11|STANDARD_ERROR_OF_MEAN|2.409||0.1991|TWO_SIDED|80.0|0.01|6.21||Primary analysis was two-sided and performed at the 0.2 significance level. No multiple comparisons adjustment was made.|Mixed Models Analysis||The estimation method used was restricted maximum likelihood.|Linear mixed-effect repeated measures model used. Fixed effects: treatment, time (visit), PANSS Total baseline value, investigator site; random effect: participant. Also included effects for treatment by time interaction and baseline value of PANSS Total by treatment interaction and background antipsychotics.||6.21|0.01|0.1991
72419317|NCT01939548|144349060|SUPERIORITY_OR_OTHER||LSM Difference|2.3|STANDARD_ERROR_OF_MEAN|2.445||0.3488|TWO_SIDED|80.0|-0.85|5.45||Primary analysis was two-sided and performed at the 0.2 significance level. No multiple comparisons adjustment was made.|Mixed Models Analysis||The estimation method used was restricted maximum likelihood.|Linear mixed-effect repeated measures model used. Fixed effects: treatment, time (visit), PANSS Total baseline value, investigator site; random effect: participant. Also included effects for treatment by time interaction and baseline value of PANSS Total by treatment interaction and background antipsychotics.||5.45|-0.85|0.3488
72612321|NCT03620162|144753401|OTHER|Estimated differences, CIs, and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percentage|-0.6|||=|0.912|TWO_SIDED|95.0|-10.4|9.3|||Miettinen & Nurminen method|||Difference in Percentage:Appetite lost(Group4 vs1)||9.3|-10.4|= 0.912
72419318|NCT01939548|144349061|SUPERIORITY_OR_OTHER||LSM Difference|-0.23|STANDARD_ERROR_OF_MEAN|1.476||0.8786|TWO_SIDED|80.0|-2.13|1.67||Analysis was two-sided and performed at the 0.2 significance level. No multiple comparisons adjustment was made.|Mixed Models Analysis||The estimation method used was restricted maximum likelihood.|Analysis of change at Week 12. Linear mixed-effect repeated measures model used. Fixed effects: treatment, time (visit), baseline value, investigator site; random effect: participant. Also included effects for treatment by time interaction and baseline value by treatment interaction and background antipsychotics.||1.67|-2.13|0.8786
72419319|NCT01939548|144349061|SUPERIORITY_OR_OTHER||LSM Difference|-1.14|STANDARD_ERROR_OF_MEAN|1.502||0.4483|TWO_SIDED|80.0|-3.08|0.79||Analysis was two-sided and performed at the 0.2 significance level. No multiple comparisons adjustment was made.|Mixed Models Analysis||The estimation method used was restricted maximum likelihood.|Analysis of change at Week 12. Linear mixed-effect repeated measures model used. Fixed effects: treatment, time (visit), baseline value, investigator site; random effect: participant. Also included effects for treatment by time interaction and baseline value by treatment interaction and background antipsychotics.||0.79|-3.08|0.4483
72419320|NCT01939548|144349062|SUPERIORITY_OR_OTHER||LSM Difference|0.81|STANDARD_ERROR_OF_MEAN|0.809||0.3201|TWO_SIDED|80.0|-0.23|1.85||Analysis was two-sided and performed at the 0.2 significance level. No multiple comparisons adjustment was made.|Mixed Models Analysis||The estimation method used was restricted maximum likelihood.|Positive Subscale Score comparison of change at Week 12. Linear mixed-effect repeated measures model used. Fixed effects: treatment, time (visit), baseline value, investigator site; random effect: participant. Also included effects for treatment by time interaction and baseline value by treatment interaction and background antipsychotics.||1.85|-0.23|0.3201
72419321|NCT01939548|144349062|SUPERIORITY_OR_OTHER||LSM Difference|0.85|STANDARD_ERROR_OF_MEAN|0.813||0.2961|TWO_SIDED|80.0|-0.19|1.9||Analysis was two-sided and performed at the 0.2 significance level. No multiple comparisons adjustment was made.|Mixed Models Analysis||The estimation method used was restricted maximum likelihood.|Positive Subscale Score comparison of change at Week 12. Linear mixed-effect repeated measures model used. Fixed effects: treatment, time (visit), baseline value, investigator site; random effect: participant. Also included effects for treatment by time interaction and baseline value by treatment interaction and background antipsychotics.||1.90|-0.19|0.2961
72419322|NCT01939548|144349062|SUPERIORITY_OR_OTHER||LSM Difference|0.39|STANDARD_ERROR_OF_MEAN|0.743||0.6015|TWO_SIDED|80.0|-0.57|1.35||Analysis was two-sided and performed at the 0.2 significance level. No multiple comparisons adjustment was made.|Mixed Models Analysis||The estimation method used was restricted maximum likelihood.|Negative Subscale Score comparison of change at Week 12. Linear mixed-effect repeated measures model used. Fixed effects: treatment, time (visit), baseline value, investigator site; random effect: participant. Also included effects for treatment by time interaction and baseline value by treatment interaction and background antipsychotics.||1.35|-0.57|0.6015
72419323|NCT01939548|144349062|SUPERIORITY_OR_OTHER||LSM Difference|0.21|STANDARD_ERROR_OF_MEAN|0.761||0.7787|TWO_SIDED|80.0|-0.77|1.19||Analysis was two-sided and performed at the 0.2 significance level. No multiple comparisons adjustment was made.|Mixed Models Analysis||The estimation method used was restricted maximum likelihood.|Negative Subscale Score comparison of change at Week 12. Linear mixed-effect repeated measures model used. Fixed effects: treatment, time (visit), baseline value, investigator site; random effect: participant. Also included effects for treatment by time interaction and baseline value by treatment interaction and background antipsychotics.||1.19|-0.77|0.7787
72419324|NCT01939548|144349062|SUPERIORITY_OR_OTHER||LSM Difference|1.63|STANDARD_ERROR_OF_MEAN|1.285||0.2068|TWO_SIDED|80.0|-0.02|3.29||Analysis was two-sided and performed at the 0.2 significance level. No multiple comparisons adjustment was made.|Mixed Models Analysis||The estimation method used was restricted maximum likelihood.|General Subscale Score comparison of change at Week 12. Linear mixed-effect repeated measures model used. Fixed effects: treatment, time (visit), baseline value, investigator site; random effect: participant. Also included effects for treatment by time interaction and baseline value by treatment interaction and background antipsychotics.||3.29|-0.02|0.2068
72419325|NCT01939548|144349062|SUPERIORITY_OR_OTHER||LSM Difference|0.98|STANDARD_ERROR_OF_MEAN|1.326||0.4611|TWO_SIDED|80.0|-0.73|2.69||Analysis was two-sided and performed at the 0.2 significance level. No multiple comparisons adjustment was made.|Mixed Models Analysis||The estimation method used was restricted maximum likelihood.|General Subscale Score comparison of change at Week 12. Linear mixed-effect repeated measures model used. Fixed effects: treatment, time (visit), baseline value, investigator site; random effect: participant. Also included effects for treatment by time interaction and baseline value by treatment interaction and background antipsychotics.||2.69|-0.73|0.4611
72612322|NCT03620162|144753401|OTHER|Estimated differences, CIs, and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percentage|-8.8|||=|0.074|TWO_SIDED|95.0|-18.3|0.9|||Miettinen & Nurminen method|||Difference in Percentage:Appetite lost(Group3 vs1)||0.9|-18.3|= 0.074
72326771|NCT00532844|144176835|SUPERIORITY||Geometric Mean Ratio|0.9||||0.139|TWO_SIDED|95.0|0.7|1.0||The model will constitute the independent variables of treatment regimen, treatment sequence, and period as fixed effects, and subject as a random effect. The dependent variable plasma BH2 concentration (AUC0-12 hr) expressed in log transformation.|Mixed Models Analysis|||To determine if administration of saproprterin dihydrochloride administered with Vitamin C results in higher plasma BH2 when compared with administration of sapropterin dihydrochloride alone in subjects with endothelial dysfunction. The difference in the plasma BH2 concentration (AUC0-12 hr) between the 2 regimens will be compared using a mixed model with a 0.05 level of significance. The difference is represented as the geometric mean ratio.||1.0|0.7|0.139
72612323|NCT03620162|144753401|OTHER|Estimated differences, CIs, and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Percentage of Participants|-3.7|||=|0.458|TWO_SIDED|95.0|-13.4|6.1|||Miettinen & Nurminen method|||Difference in Percentage:Appetite lost(Group2 vs1)||6.1|-13.4|= 0.458
72612324|NCT03620162|144753401|OTHER|Estimated differences, CIs, and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percentage|2.8|||=|0.568|TWO_SIDED|95.0|-6.8|12.3|||Miettinen & Nurminen method|||Difference in Percentage:Irritability(Group 5 vs1)||12.3|-6.8|= 0.568
72419326|NCT01939548|144349063|SUPERIORITY_OR_OTHER||LSM Difference|0.96|STANDARD_ERROR_OF_MEAN|0.591||0.1083|TWO_SIDED|80.0|0.19|1.72||Analysis was two-sided and performed at the 0.2 significance level. No multiple comparisons adjustment was made.|Mixed Models Analysis||The estimation method used was restricted maximum likelihood.|Anxiety/depression symptom score comparison of change at Week 12. Linear mixed-effect repeated measures model used. Fixed effects: treatment, time (visit), baseline value, investigator site; random effect: participant. Also included effects for treatment by time interaction and baseline value by treatment interaction and background antipsychotics.||1.72|0.19|0.1083
72419327|NCT01939548|144349063|SUPERIORITY_OR_OTHER||LSM Difference|1.05|STANDARD_ERROR_OF_MEAN|0.611||0.0869|TWO_SIDED|80.0|0.27|1.84||Analysis was two-sided and performed at the 0.2 significance level. No multiple comparisons adjustment was made.|Mixed Models Analysis||The estimation method used was restricted maximum likelihood.|Anxiety/depression symptom score comparison of change at Week 12. Linear mixed-effect repeated measures model used. Fixed effects: treatment, time (visit), baseline value, investigator site; random effect: participant. Also included effects for treatment by time interaction and baseline value by treatment interaction and background antipsychotics.||1.84|0.27|0.0869
72419328|NCT01939548|144349063|SUPERIORITY_OR_OTHER||LSM Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.575||0.8601|TWO_SIDED|80.0|-0.84|0.64||Analysis was two-sided and performed at the 0.2 significance level. No multiple comparisons adjustment was made.|Mixed Models Analysis||The estimation method used was restricted maximum likelihood.|Disorganized thought symptom score comparison of change at Week 12. Linear mixed-effect repeated measures model used. Fixed effects: treatment, time (visit), baseline value, investigator site; random effect: participant. Also included effects for treatment by time interaction and baseline value by treatment interaction and background antipsychotics.||0.64|-0.84|0.8601
72419329|NCT01939548|144349063|SUPERIORITY_OR_OTHER||LSM Difference|-0.56|STANDARD_ERROR_OF_MEAN|0.593||0.3454|TWO_SIDED|80.0|-1.33|0.2||Analysis was two-sided and performed at the 0.2 significance level. No multiple comparisons adjustment was made.|Mixed Models Analysis||The estimation method used was restricted maximum likelihood.|Disorganized thought symptom score comparison of change at Week 12. Linear mixed-effect repeated measures model used. Fixed effects: treatment, time (visit), baseline value, investigator site; random effect: participant. Also included effects for treatment by time interaction and baseline value by treatment interaction and background antipsychotics.||0.20|-1.33|0.3454
72419330|NCT01939548|144349063|SUPERIORITY_OR_OTHER||LSM Difference|0.78|STANDARD_ERROR_OF_MEAN|0.789||0.3273|TWO_SIDED|80.0|-0.24|1.79||Analysis was two-sided and performed at the 0.2 significance level. No multiple comparisons adjustment was made.|Mixed Models Analysis||The estimation method used was restricted maximum likelihood.|Negative symptom score comparison of change at Week 12. Linear mixed-effect repeated measures model used. Fixed effects: treatment, time (visit), baseline value, investigator site; random effect: participant. Also included effects for treatment by time interaction and baseline value by treatment interaction and background antipsychotics.||1.79|-0.24|0.3273
72419331|NCT01939548|144349063|SUPERIORITY_OR_OTHER||LSM Difference|0.69|STANDARD_ERROR_OF_MEAN|0.806||0.3963|TWO_SIDED|80.0|-0.35|1.72||Analysis was two-sided and performed at the 0.2 significance level. No multiple comparisons adjustment was made.|Mixed Models Analysis||The estimation method used was restricted maximum likelihood.|Negative symptom score comparison of change at Week 12. Linear mixed-effect repeated measures model used. Fixed effects: treatment, time (visit), baseline value, investigator site; random effect: participant. Also included effects for treatment by time interaction and baseline value by treatment interaction and background antipsychotics.||1.72|-0.35|0.3963
72419332|NCT01939548|144349063|SUPERIORITY_OR_OTHER||LSM Difference|0.64|STANDARD_ERROR_OF_MEAN|0.888||0.4713|TWO_SIDED|80.0|-0.5|1.78||Analysis was two-sided and performed at the 0.2 significance level. No multiple comparisons adjustment was made.|Mixed Models Analysis||The estimation method used was restricted maximum likelihood.|Positive symptom score comparison of change at Week 12. Linear mixed-effect repeated measures model used. Fixed effects: treatment, time (visit), baseline value, investigator site; random effect: participant. Also included effects for treatment by time interaction and baseline value by treatment interaction and background antipsychotics.||1.78|-0.50|0.4713
72419333|NCT01939548|144349063|SUPERIORITY_OR_OTHER||LSM Difference|1.21|STANDARD_ERROR_OF_MEAN|0.895||0.1787|TWO_SIDED|80.0|0.06|2.36||Analysis was two-sided and performed at the 0.2 significance level. No multiple comparisons adjustment was made.|Mixed Models Analysis||The estimation method used was restricted maximum likelihood.|Positive symptom score comparison of change at Week 12. Linear mixed-effect repeated measures model used. Fixed effects: treatment, time (visit), baseline value, investigator site; random effect: participant. Also included effects for treatment by time interaction and baseline value by treatment interaction and background antipsychotics.||2.36|0.06|0.1787
72612325|NCT03620162|144753401|OTHER|Estimated differences, CIs, and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percentage|0.6|||=|0.91|TWO_SIDED|95.0|-9.1|10.2|||Miettinen & Nurminen method|||Difference in Percentage:Irritability(Group 4 vs1)||10.2|-9.1|= 0.910
72612326|NCT03620162|144753401|OTHER|Estimated differences, CIs, and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percentage|-4.7|||=|0.354|TWO_SIDED|95.0|-14.5|5.2|||Miettinen & Nurminen method|||Difference in Percentage:Irritability(Group 3 vs1)||5.2|-14.5|= 0.354
72612327|NCT03620162|144753401|OTHER|Estimated differences, CIs, and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percentage|-6.8|||=|0.178|TWO_SIDED|95.0|-16.6|3.1|||Miettinen & Nurminen method|||Difference in Percentage:Irritability(Group 2 vs1)||3.1|-16.6|= 0.178
72326772|NCT00532844|144176835|SUPERIORITY||Geometric Mean Ratio|0.96||||0.57|TWO_SIDED|95.0|0.83|1.11||The model will constitute independent variables of treatment regimen, treatment sequence, and period as fixed effects, and subject as a random effect. The dependent variable Total B concentration (AUC0-12 hr) expressed in log transformation.|Mixed Models Analysis|||To determine if administration of saproprterin dihydrochloride administered with Vitamin C results in Total B (biopterin) when compared with administration of sapropterin dihydrochloride alone in subjects with endothelial dysfunction. The difference in the Total B (biopterin) concentration (AUC0-12 hr) between the 2 regimens will be compared using a mixed model with a 0.05 level of significance. The difference is represented as the geometric mean ratio.||1.11|0.83|0.570
72419334|NCT01939548|144349063|SUPERIORITY_OR_OTHER||LSM Difference|0.35|STANDARD_ERROR_OF_MEAN|0.426||0.4123|TWO_SIDED|80.0|-0.2|0.9||Analysis was two-sided and performed at the 0.2 significance level. No multiple comparisons adjustment was made.|Mixed Models Analysis||The estimation method used was restricted maximum likelihood.|Uncontrolled hostility/excitement symptom score comparison of change at Week 12. Linear mixed-effect repeated measures model used. Fixed effects: treatment, time (visit), baseline value, investigator site; random effect: participant. Also included effects for treatment by time interaction and baseline value by treatment interaction and background antipsychotics.||0.90|-0.20|0.4123
72419335|NCT01939548|144349063|SUPERIORITY_OR_OTHER||LSM Difference|-0.44|STANDARD_ERROR_OF_MEAN|0.441||0.3202|TWO_SIDED|80.0|-1.01|0.13||Analysis was two-sided and performed at the 0.2 significance level. No multiple comparisons adjustment was made.|Mixed Models Analysis||The estimation method used was restricted maximum likelihood.|Uncontrolled hostility/excitement symptom score comparison of change at Week 12. Linear mixed-effect repeated measures model used. Fixed effects: treatment, time (visit), baseline value, investigator site; random effect: participant. Also included effects for treatment by time interaction and baseline value by treatment interaction and background antipsychotics.||0.13|-1.01|0.3202
72419336|NCT01939548|144349064|SUPERIORITY_OR_OTHER||LSM Difference|0.04|STANDARD_ERROR_OF_MEAN|0.119||0.7399|TWO_SIDED|80.0|-0.11|0.19||Analysis was two-sided and performed at the 0.2 significance level. No multiple comparisons adjustment was made.|Mixed Models Analysis||The estimation method used was restricted maximum likelihood.|Analysis of change at Week 12. Linear mixed-effect repeated measures model used. Fixed effects: treatment, time (visit), baseline value, investigator site; random effect: participant. Also included effects for treatment by time interaction and baseline value by treatment interaction and background antipsychotics.||0.19|-0.11|0.7399
72419337|NCT01939548|144349064|SUPERIORITY_OR_OTHER||LSM Difference|0.13|STANDARD_ERROR_OF_MEAN|0.122||0.2747|TWO_SIDED|80.0|-0.02|0.29||Analysis was two-sided and performed at the 0.2 significance level. No multiple comparisons adjustment was made.|Mixed Models Analysis||The estimation method used was restricted maximum likelihood.|Analysis of change at Week 12. Linear mixed-effect repeated measures model used. Fixed effects: treatment, time (visit), baseline value, investigator site; random effect: participant. Also included effects for treatment by time interaction and baseline value by treatment interaction and background antipsychotics.||0.29|-0.02|0.2747
72419338|NCT01939548|144349065|SUPERIORITY_OR_OTHER||LSM Difference|0.07|STANDARD_ERROR_OF_MEAN|0.188||0.7219|TWO_SIDED|80.0|-0.17|0.31||Analysis was two-sided and performed at the 0.2 significance level. No multiple comparisons adjustment was made.|ANOVA|||Analysis of change at Week 12. Mixed effect repeated measures model used. Fixed effects: treatment, time (visit), baseline value, investigator site, visit and visit-by-treatment interaction; random effect: participant.||0.31|-0.17|0.7219
72419339|NCT01939548|144349065|SUPERIORITY_OR_OTHER||LSM Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.192||0.9315|TWO_SIDED|80.0|-0.26|0.23||Analysis was two-sided and performed at the 0.2 significance level. No multiple comparisons adjustment was made.|ANOVA|||Analysis of change at Week 12. Mixed effect repeated measures model used. Fixed effects: treatment, time (visit), baseline value, investigator site, visit and visit-by-treatment interaction; random effect: participant.||0.23|-0.26|0.9315
72419340|NCT00101933|144349081|SUPERIORITY_OR_OTHER|||||||0.0017||95.0||||Since a treatment-by-visit interaction remains in the final model, the results were analyzed by visit. The results shown are for the last month in the blinded phase (month 3-4).|Generalized Estimating Equations|This analysis is adjusted for significant baseline covariates.||The numbers presented are the percentage reduction in the number of seizures in each group. A negative percentage change indicates a seizure reduction.||||0.0017
72419341|NCT00101933|144349083|SUPERIORITY_OR_OTHER||Rate per 1000 years of stimulation|4.9|||||TWO_SIDED|95.0|0.6|17.79|||No statistical test||The rate is calculated per 1000 subject years of follow-up based on 406 subject years of stimulation. The confidence interval is the 95% Poisson confidence interval. Per protocol, only definite and probable SUDEP were included in the calculation.|||17.79|0.60|
72419342|NCT00101933|144349084|SUPERIORITY_OR_OTHER|||||||0.83||95.0|||||Fisher Exact|||Fisher's Exact test. The numbers presented in this analysis are the number of subjects who were responders based on a responder definition including all subjects with 50% or greater improvement in total seizure count.||||0.830
72419343|NCT00101933|144349085|SUPERIORITY_OR_OTHER|||||||0.105||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.105
72419344|NCT00101933|144349086|SUPERIORITY_OR_OTHER|||||||0.498||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.498
72326773|NCT00532844|144176838|SUPERIORITY|||||||0.593|||||||ANCOVA|The model will have the treatments and the baseline measurement as independent variables and measurement at Day 13 as the dependent variable.||The raw value of PAT obtained from the first period (baseline to Day 13) will be used to compare the two treatments.||||0.593
72419345|NCT00101933|144349087|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|||||||1.0
72419346|NCT00101933|144349088|SUPERIORITY_OR_OTHER|||||||0.0387||95.0||||Since a visit-by-treatment interaction did not remain in the final model, the results shown are for the entire blinded phase.|Generalized Estimating Equations|This analysis is adjusted for significant baseline covariates.||The numbers presented are the percentage reduction in the number of seizures in each group. A negative percentage change indicates a seizure reduction.||||0.0387
72419347|NCT00101933|144349089|SUPERIORITY_OR_OTHER|||||||0.047||95.0|||||Wilcoxon (Mann-Whitney)|||Numbers provided indicate the percentage change from baseline in seizure frequency of each participant's most severe seizures. Negative values indicate improvement from baseline.||||0.047
72419348|NCT00774579|144349091|SUPERIORITY|||||||0.6|||||||t-test, 2 sided|||||||0.6
72419349|NCT00774579|144349092|SUPERIORITY|||||||0.1|||||||t-test, 2 sided|||||||0.1
72419350|NCT02638948|144349152|SUPERIORITY||Estimate of Difference (%)|4.9||||0.5224|TWO_SIDED|95.0|-10.2|20.1||Threshold for significance = 0.05|Chi-squared|||||20.1|-10.2|0.5224
72419351|NCT02638948|144349152|SUPERIORITY||Estimate of Difference (%)|11.8||||0.136|TWO_SIDED|95.0|-3.6|27.2||Threshold for significance = 0.05|Chi-squared|||||27.2|-3.6|0.1360
72419352|NCT02638948|144349152|SUPERIORITY||Estimate of Difference (%)|0.1||||0.9922|TWO_SIDED|95.0|-20.5|20.7||Threshold for significance = 0.05|Chi-squared|||||20.7|-20.5|0.9922
72419353|NCT02638948|144349153|SUPERIORITY||Estimate of Difference (%)|0.1||||1|TWO_SIDED|95.0|-16.0|16.5||Threshold for significance = 0.05|Chi-squared|||||16.5|-16.0|1.0000
72419354|NCT02638948|144349153|SUPERIORITY||Estimate of Difference (%)|5.6||||0.2058|TWO_SIDED|95.0|-10.5|21.9||Threshold for significance = 0.05|Chi-squared|||||21.9|-10.5|0.2058
72419355|NCT02638948|144349153|SUPERIORITY||Estimate of Difference (%)|-0.2||||1|TWO_SIDED|95.0|-22.5|22.2||Threshold for significance = 0.05|Chi-squared|||||22.2|-22.5|1.0000
72419356|NCT02963974|144349177|SUPERIORITY||||||<|0.001||||||The a priori threshold for statistical significance was \< 0.05.|Mixed Models Analysis|||Analyzed CNC Word scores from 3 months through 24 months to evaluate change over time with device use. Scores were converted to Rau prior to analysis.||||< 0.001
72419357|NCT02963974|144349177|SUPERIORITY||||||<|0.001||||||The a priori threshold for statistical significance was p \< 0.05.|Wilcoxon (Mann-Whitney)|||Analyzed pre-op to 3 month post activation CNC Word scores to test superiority of cochlear implant use to pre-operative hearing aid use.||||< 0.001
72419358|NCT02963974|144349179|SUPERIORITY||||||<|0.001||||||The a priori threshold for statistical significance was \< 0.05. This was a two-way repeated measures ANOVA.|ANOVA|||Analyzed BKB-SIN SNR-50 scores at 12 months post activation to evaluate the impact of device use (CI off vs on) and masker location (front, to the affected ear, or to the normal hearing ear) on hearing in noise.||||< 0.001
72419359|NCT02963974|144349180|SUPERIORITY||||||<|0.001||||||The a priori threshold for statistical significance was \< 0.05.|Mixed Models Analysis|||Analyzed BKB-SIN SNR-50 scores across all time points (6, 12, and 24 months post activation) to evaluate the impact of time, device use (CI off vs on), and masker location (front, to the affected ear, or to the normal hearing ear) on hearing in noise.||||< 0.001
72419360|NCT02963974|144349184|SUPERIORITY|||||||0.01911||||||The a priori threshold for statistical significance was \< 0.05.|Mixed Models Analysis|||Analyzed overall RMS error at 3, 9, 18, and 24 months post activation to evaluate the impact of device use (CI off vs on) and time on localization.||||0.01911
72419361|NCT02963974|144349185|SUPERIORITY||||||<|0.001||||||The a priori threshold for statistical significance was p \< 0.05|Mixed Models Analysis|||Comparison of scores across time to investigate change in scores over time: Speech subtest.||||< 0.001
72612328|NCT03620162|144753401|OTHER|Estimated differences, CIs, and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percentage|3.4|||=|0.52|TWO_SIDED|95.0|-6.8|13.5|||Miettinen & Nurminen method|||Difference in Percentage: Drowsiness(Group 5 vs 1)||13.5|-6.8|= 0.520
72612329|NCT03620162|144753401|OTHER|Estimated differences, CIs, and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percentage|0.0|||>|0.999|TWO_SIDED|95.0|-10.2|10.2|||Miettinen & Nurminen method|||Difference in Percentage: Drowsiness(Group 4 vs 1)||10.2|-10.2|> 0.999
72326774|NCT02020590|144176846|OTHER||||||||TWO_SIDED|90.0||||||||"The success of ALLOB® treatment was based on the percentage of responders. A treated patient was considered as responding if, at the end of the study (6 months):~* He/she had not required rescue surgery and~* The GDE score as perceived by the patient had improved by at least 25% or the TUS (tomographic union score) as assessed by CT scan had increased by at least 2 points."|The response rate at Month 6 for the 21 patients in the PP population was 100 % (CI: 86.71 - 100.0%). None of the treated patients required rescue surgery. An improvement of GDE score of at least 25% was reported for 16 (76.2%) patients. An increase in TUS of at least 2 points was reported for 16 (76.2%) patients; all patients met at least one of these two criteria.|||
72419362|NCT02963974|144349185|SUPERIORITY|||||||0.001||||||The a priori threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|||Comparison of scores across time to investigate change in scores over time: Spatial subtest.||||0.001
72326775|NCT01490918|144176863|SUPERIORITY|||||||0.0036||||||The threshold for statistical significance was p=0.05|ANCOVA|Baselin HbA1c as covariate||primary outcome efficacy will be evaluated between group 1(placebo + metfromin + sitagliptin) and 2 (sitagliptine + metformin + acarbose)||||0.0036
72326776|NCT01490918|144176864|SUPERIORITY||||||<|0.0001||||||The threshold for statistical significance was p=0.05|ANCOVA|Baseline HbA1c as covariate||||||<0.0001
72419363|NCT02963974|144349185|SUPERIORITY||||||<|0.001||||||The a priori threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|||Comparison of scores across time to investigate change in scores over time: Qualities subtest.||||< 0.001
72419364|NCT02963974|144349186|SUPERIORITY||||||<|0.001||||||The a priori threshold for statistical significance was p \< 0.05|Mixed Models Analysis|||Comparison of scores over time.||||< 0.001
72419365|NCT02963974|144349187|SUPERIORITY|||||||0.1009||||||The a priori threshold for statistical significance was p \< 0.05|Mixed Models Analysis|||Comparison of scores to evaluation change over time: General Fatigue Subtest||||0.1009
72419366|NCT02963974|144349187|SUPERIORITY|||||||0.109||||||The a priori threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|||Comparison of scores to evaluation change over time: Sleep Fatigue Subtest||||0.109
72419367|NCT02963974|144349187|SUPERIORITY|||||||0.1733||||||The a priori threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|||Comparison of scores to evaluation change over time: Cognitive Fatigue Subtest||||0.1733
72419368|NCT00810264|144349188|NON_INFERIORITY|The primary safety endpoint 1 hypothesis was evaluated by performing an exact, non-inferiority test comparing a binomial proportion (overall SAEFR at 5 years) to 92.5%, with a non-inferiority delta of 5%.|||||<|0.0001|||||||Binomial Proportion|||||||<0.0001
72419369|NCT00313820|144349226|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.29||0.578||95.0|-0.7|0.4|||ANCOVA|ANCOVA with treatment and country as factors and baseline pain score as covariate.||Modelled Results: Endpoint Mean Pain Score Pregabalin vs Placebo||0.4|-0.7|0.578
72419370|NCT00313820|144349226|SUPERIORITY_OR_OTHER_LEGACY|||||||0.294||95.0||||Interaction p-value based on adding interaction term to the main model.|ANCOVA|||Modelled Results: Treatment by country interaction||||0.294
72419371|NCT00313820|144349227|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.25||0.161||95.0|-0.8|0.1||Estimated from a repeated measures linear mixed model with treatment, week, country and treatment by week interaction as factors and baseline value as a covariate. A compound symmetry covariance structure is specified.|Mixed Models Analysis|||Week 1 Modelled Results||0.1|-0.8|0.161
72419372|NCT00313820|144349227|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|0.25||0.062||95.0|-1.0|0.0||Estimated from a repeated measures linear mixed model with treatment, week, country and treatment by week interaction as factors and baseline value as a covariate. A compound symmetry covariance structure is specified.|Mixed Models Analysis|||Week 2 Modelled Results||0.0|-1.0|0.062
72419373|NCT00313820|144349227|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.25||0.024||95.0|-1.1|-0.1||Estimated from a repeated measures linear mixed model with treatment, week, country and treatment by week interaction as factors and baseline value as a covariate. A compound symmetry covariance structure is specified.|Mixed Models Analysis|||Week 3 Modelled Results||-0.1|-1.1|0.024
72419374|NCT00313820|144349227|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.25||0.026||95.0|-1.1|-0.1||Estimated from a repeated measures linear mixed model with treatment, week, country and treatment by week interaction as factors and baseline value as a covariate. A compound symmetry covariance structure is specified.|Mixed Models Analysis|||Week 6 Modelled Results||-0.1|-1.1|0.026
72419375|NCT00313820|144349227|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.25||0.105||95.0|-0.9|0.1||Estimated from a repeated measures linear mixed model with treatment, week, country and treatment by week interaction as factors and baseline value as a covariate. A compound symmetry covariance structure is specified.|Mixed Models Analysis|||Week 9 Modelled Results||0.1|-0.9|0.105
72419376|NCT00313820|144349227|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.25||0.592||95.0|-0.6|0.4||Estimated from a repeated measures linear mixed model with treatment, week, country and treatment by week interaction as factors and baseline value as a covariate. A compound symmetry covariance structure is specified.|Mixed Models Analysis|||Week 12 Modelled Results||0.4|-0.6|0.592
72419377|NCT00313820|144349228|SUPERIORITY_OR_OTHER_LEGACY|||||||0.087||95.0||||Cochran-Mantel-Haenszel (CMH) test comparing pregabalin to placebo adjusted for country under the null hypothesis of no treatment difference.|Cochran-Mantel-Haenszel|||30% Responders||||0.087
72419378|NCT00313820|144349229|SUPERIORITY_OR_OTHER_LEGACY|||||||0.622||95.0||||Cochran-Mantel-Haenszel (CMH) test comparing pregabalin to placebo adjusted for country under the null hypothesis of no treatment difference.|Cochran-Mantel-Haenszel|||50% Responders||||0.622
72419379|NCT00313820|144349230|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|0.23||0.027||95.0|-1.0|-0.1||Estimated from a repeated measures linear mixed model with treatment, week, country and treatment by week interaction as factors and baseline value as a covariate. A compound symmetry covariance structure is specified.|Mixed Models Analysis|||Week 1; Modelled Results||-0.1|-1.0|0.027
72419380|NCT00313820|144349230|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|0.24||0.038||95.0|-1.0|0.0||Estimated from a repeated measures linear mixed model with treatment, week, country and treatment by week interaction as factors and baseline value as a covariate. A compound symmetry covariance structure is specified.|Mixed Models Analysis|||Week 2; Modelled Results||-0.0|-1.0|0.038
72419381|NCT00313820|144349230|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|0.24||0.004||95.0|-1.2|-0.2||Estimated from a repeated measures linear mixed model with treatment, week, country and treatment by week interaction as factors and baseline value as a covariate. A compound symmetry covariance structure is specified.|Mixed Models Analysis|||Week 3; Modelled Results||-0.2|-1.2|0.004
72612330|NCT03620162|144753401|OTHER|Estimated differences, CIs, and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percentage|-0.2|||=|0.963|TWO_SIDED|95.0|-10.5|10.0|||Miettinen & Nurminen method|||Difference in Percentage: Drowsiness(Group 3 vs 1)||10.0|-10.5|= 0.963
72612331|NCT03620162|144753401|OTHER|Estimated differences, CIs, and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percentage|-1.2|||=|0.821|TWO_SIDED|95.0|-11.4|9.0|||Miettinen & Nurminen method|||Difference in Percentage: Drowsiness(Group 2 vs 1)||9.0|-11.4|= 0.821
72612332|NCT03620162|144753401|OTHER|Estimated differences, CIs, and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percentage|-0.6|||=|0.836|TWO_SIDED|95.0|-6.1|5.0|||Miettinen & Nurminen method|||Difference in Percentage: Hives(Group 5 vs 1)||5.0|-6.1|= 0.836
72419382|NCT00313820|144349230|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|0.24||0.005||95.0|-1.1|-0.2||Estimated from a repeated measures linear mixed model with treatment, week, country and treatment by week interaction as factors and baseline value as a covariate. A compound symmetry covariance structure is specified.|Mixed Models Analysis|||Week 6; Modelled Results||-0.2|-1.1|0.005
72419383|NCT00313820|144349230|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.24||0.078||95.0|-0.9|0.0||Estimated from a repeated measures linear mixed model with treatment, week, country and treatment by week interaction as factors and baseline value as a covariate. A compound symmetry covariance structure is specified.|Mixed Models Analysis|||Week 9; Modelled Results||0.0|-0.9|0.078
72419384|NCT00313820|144349230|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.24||0.663||95.0|-0.6|0.4||Estimated from a repeated measures linear mixed model with treatment, week, country and treatment by week interaction as factors and baseline value as a covariate. A compound symmetry covariance structure is specified.|Mixed Models Analysis|||Week 12; Modelled Results||0.4|-0.6|0.663
72419385|NCT00313820|144349230|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.26||0.627||95.0|-0.6|0.4||Estimated from a repeated measures linear mixed model with treatment, week, country and treatment by week interaction as factors and baseline value as a covariate. A compound symmetry covariance structure is specified.|Mixed Models Analysis|||Endpoint \[Week 12 or ET\]; Modelled Results||0.4|-0.6|0.627
72419386|NCT00313820|144349231|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.0|STANDARD_ERROR_OF_MEAN|3.05||0.741||95.0|-7.0|5.0||Estimated from ANCOVA (general linear model) with treatment and country as factors and baseline value as a covariate|ANCOVA|||Modelled Results||5.0|-7.0|0.741
72419387|NCT00313820|144349232|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.31||0.216||95.0|-1.0|0.2||Estimated from ANCOVA (general linear model) with treatment and country as factors and baseline score as a covariate.|ANCOVA|||Burning Pain Week 12 \[LOCF\]; Modelled Results||0.2|-1.0|0.216
72612333|NCT03620162|144753401|OTHER|Estimated differences, CIs, and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percentage|1.7|||=|0.562|TWO_SIDED|95.0|-4.2|7.6|||Miettinen & Nurminen method|||Difference in Percentage: Hives(Group 4 vs 1)||7.6|-4.2|= 0.562
72419388|NCT00313820|144349232|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.25||0.76||95.0|-0.4|0.6||Estimated from ANCOVA (general linear model) with treatment and country as factors and baseline score as a covariate.|ANCOVA|||Pressing Pain Week 12 \[LOCF\]; Modelled Results||0.6|-0.4|0.760
72419389|NCT00313820|144349232|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.24||0.36||95.0|-0.7|0.3||Estimated from ANCOVA (general linear model) general linear model with treatment and country as factors and baseline score as a covariate.|ANCOVA|||Paroxysmal Pain Week 12 \[LOCF\]; Modelled Results||0.3|-0.7|0.360
72419390|NCT00313820|144349232|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.26||0.239||95.0|-0.8|0.2||Estimated from ANCOVA (general linear model) with treatment and country as factors and baseline score as a covariate.|ANCOVA|||Evoked Pain Week 12 \[LOCF\]; Modelled Results||0.2|-0.8|0.239
72419391|NCT00313820|144349232|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.27||0.118||95.0|-1.0|0.1||Estimated from ANCOVA (general linear model) with treatment and country as factors and baseline score as a covariate.|ANCOVA|||P/D Week 12 \[LOCF\]; Modelled Results||0.1|-1.0|0.118
72419392|NCT00313820|144349232|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.8|STANDARD_ERROR_OF_MEAN|1.87||0.138||95.0|-6.5|0.9||Estimated from ANCOVA (general linear model) with treatment and country as factors and baseline score as a covariate.|ANCOVA|||Total Score Week 12 \[LOCF\]; Modelled Results||0.9|-6.5|0.138
72419393|NCT00313820|144349233|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.8|STANDARD_ERROR_OF_MEAN|2.79||0.086||95.0|-10.3|0.7||Estimated from ANCOVA (general linear model) with treatment and country as factors and the baseline assessment as a covariate.|ANCOVA|||Sleep disturbance; Modelled Results||0.7|-10.3|0.086
72419394|NCT00313820|144349233|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|7.7|STANDARD_ERROR_OF_MEAN|3.72||0.039||95.0|0.4|15.1||Estimated from ANCOVA (general linear model) with treatment and country as factors and the baseline assessment as a covariate.|ANCOVA|||Snoring score; Modelled Results||15.1|0.4|0.039
72419395|NCT00313820|144349233|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.7|STANDARD_ERROR_OF_MEAN|2.71||0.169||95.0|-9.1|1.6||Estimated from ANCOVA (general linear model) with treatment and country as factors and the baseline assessment as a covariate.|ANCOVA|||Awaken SOB or headache; Modelled Results||1.6|-9.1|0.169
72419396|NCT00313820|144349233|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.4|STANDARD_ERROR_OF_MEAN|0.17||0.03||95.0|0.0|0.7||Estimated from ANCOVA (general linear model) with treatment and country as factors and the baseline assessment as a covariate.|ANCOVA|||Sleep quantity; Modelled Results||0.7|0.0|0.030
72419397|NCT00313820|144349233|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|8.6|STANDARD_ERROR_OF_MEAN|3.44||0.013||95.0|1.8|15.4||Estimated from ANCOVA (general linear model) with treatment and country as factors and the baseline assessment as a covariate.|ANCOVA|||Sleep adequacy; Modelled Results||15.4|1.8|0.013
72419398|NCT00313820|144349233|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.1|STANDARD_ERROR_OF_MEAN|2.51||0.399||95.0|-2.8|7.1||Estimated from ANCOVA (general linear model) with treatment and country as factors and the baseline assessment as a covariate.|ANCOVA|||Somnolence; Modelled Results||7.1|-2.8|0.399
72326777|NCT01490918|144176865|SUPERIORITY|||||||0.0185||||||The threshold for statistical significance was p=0.05|ANCOVA|baseline PPG2hr as covariate||||||0.0185
72326778|NCT01490918|144176866|SUPERIORITY|||||||0.0356||||||The threshold for statistical significance was p=0.05|ANCOVA|baseline data as covariate||||||0.0356
72419399|NCT00313820|144349233|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.2|STANDARD_ERROR_OF_MEAN|2.13||0.049||95.0|-8.4|0.0||Estimated from ANCOVA (general linear model) with treatment and country as factors and the baseline assessment as a covariate.|ANCOVA|||Overall sleep problems index; Modelled Results||-0.0|-8.4|0.049
72419400|NCT00313820|144349234|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.5|STANDARD_ERROR_OF_MEAN|0.5||0.201||95.0|0.8|2.9||Estimated from a logistic regression model with treatment and the baseline assessment as factors.|Regression, Logistic||Standard error of the mean = standard error of the odds ratio.|Modelled Results||2.9|0.8|0.201
72419401|NCT00313820|144349235|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.0|STANDARD_ERROR_OF_MEAN|0.4||0.015||95.0|-1.8|-0.2||Estimated from ANCOVA (general linear model) with treatment and country as factors and baseline score as a covariate.|ANCOVA|||Week 12 \[LOCF\] Anxiety score; Modelled Results||-0.2|-1.8|0.015
72419402|NCT00313820|144349235|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|0.41||0.6||95.0|-0.6|1.0||Estimated from ANCOVA (general linear model) with treatment and country as factors and baseline score as a covariate.|ANCOVA|||Week 12 \[LOCF\] Depression score; Modelled Results||1.0|-0.6|0.600
72419403|NCT00313820|144349236|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.04||0.566||95.0|-0.1|0.1||Estimated from ANCOVA (general linear model) with treatment and country as factors and baseline score as a covariate.|ANCOVA|||Modelled Results||0.1|-0.1|0.566
72326779|NCT01490918|144176867|SUPERIORITY|||||||0.8258||||||The threshold for statistical significance was p=0.05|ANCOVA|baseline data as covariate||||||0.8258
72326780|NCT01490918|144176868|SUPERIORITY|||||||0.9217||||||The threshold for statistical significance was p=0.05|ANCOVA|baseline data as covariate||||||0.9217
72326781|NCT01490918|144176869|SUPERIORITY|||||||0.16||||||The threshold for statistical significance was p=0.05|ANCOVA|baseline data as covariate||||||0.16
72326782|NCT01490918|144176870|SUPERIORITY|||||||0.004||||||The threshold for statistical significance was p=0.05|ANCOVA|baseline data as covariate||||||0.004
72419404|NCT00313820|144349237|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.0|STANDARD_ERROR_OF_MEAN|2.47||0.22||95.0|-1.8|7.9||Estimated from ANCOVA (general linear model) with treatment and coutntry as factors and baseline score as a covariate.|ANCOVA|||Modelled Results||7.9|-1.8|0.220
72419405|NCT00313820|144349238|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.14||0.144||95.0|-0.5|0.1||Estimated from ANCOVA (general linear model) with treament and country as factors.|ANCOVA|||Modelled Results||0.1|-0.5|0.144
72419406|NCT00313820|144349239|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.14||0.049||95.0|-0.6|0.0||Estimated from ANCOVA (general linear model) with treatment and country as factors.|ANCOVA|||Modelled Results||-0.0|-0.6|0.049
72419407|NCT00251862|144349247|SUPERIORITY_OR_OTHER||Absolute Difference|8.3||||0.046|TWO_SIDED|95.0|-2.2|14.2|||Chi-squared|||Sample size and power considerations focused on a two-group comparison of the DA alone versus control study arms for the primary outcome of colorectal cancer (CRC) screening test completion at 12 months. Based on crude estimates of baseline test completion rates, we calculated that a target sample of 275 subjects per arm provided greater than 80% power of detecting a 54% vs. 40% difference at the P\<0.05 level.||14.2|-2.2|0.046
72419408|NCT00251862|144349247|SUPERIORITY_OR_OTHER||Absolute Difference|6.0||||0.153|TWO_SIDED|95.0|0.2|16.5|||Chi-squared|||||16.5|0.2|0.153
72419409|NCT00251862|144349248|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Pairwise comparisons: DA+YDR vs. Control, P\<0.001; DA alone vs. Control, P\<0.001|ANCOVA|||The three study groups were compared on cumulative pre-test and post-test knowledge through separate one-factor analysis of covariance (ANCOVA); followed pairwise comparisons using Bonferroni's adjusted multiple comparison procedure.||||<0.001
72419410|NCT00251862|144349249|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||The three study groups were compared through separate one-factor analysis of covariance (ANCOVA); followed pairwise comparisons using Bonferroni's adjusted multiple comparison procedure.||||<0.001
72419411|NCT00251862|144349250|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANCOVA|||The three study groups were compared through separate one-factor analysis of covariance (ANCOVA); followed pairwise comparisons using Bonferroni's adjusted multiple comparison procedure.||||<0.001
72419412|NCT02134587|144349255|SUPERIORITY_OR_OTHER_LEGACY|||||||1e-05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.00001
72419413|NCT02134587|144349256|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
72419414|NCT01515748|144349258|SUPERIORITY|||||||0.0152||||||Threshold for statistical significance at 0.049.|Stratified Log Rank|||Analysis was performed using Kaplan-Meier method. Comparison was stratified based on site and TNM classification (T4/N-, T2/N+, T3-4/N+).||||0.0152
72326783|NCT01490918|144176871|SUPERIORITY|||||||0.292||||||The threshold for statistical significance was p=0.05|ANCOVA|baseline data as covariate||||||0.292
72419415|NCT00416182|144349268|SUPERIORITY_OR_OTHER|||||||0.2|TWO_SIDED|95.0||||P-value of \< 0.05 is considered significant|t-test, 2 sided|||||||0.2
72419416|NCT00416182|144349269|SUPERIORITY_OR_OTHER|||||||0.048|TWO_SIDED|95.0||||P-value of \< 0.05 is considered significant.|t-test, 2 sided|||||||0.048
72419417|NCT00416182|144349270|SUPERIORITY_OR_OTHER|||||||0.003|TWO_SIDED|95.0||||P-value \< 0.05 is considered significant|t-test, 2 sided|||||||0.003
72419418|NCT00416182|144349271|SUPERIORITY_OR_OTHER|||||||0.4|TWO_SIDED|||||P \<0.05 is considered significant|t-test, 2 sided|||||||0.4
72419419|NCT04102579|144349295|OTHER||Least Squares (LS) Means Difference|-3.16|STANDARD_ERROR_OF_MEAN|0.61|<|0.0001|TWO_SIDED|95.0|-4.37|-1.95||Statistical significance achieved if p-value \<0.05.|MMRM||LS Means Difference = Valbenazine - Placebo|Results were analyzed using a mixed-effect model repeated measures (MMRM) analysis. The model included the screening period baseline TMC as a covariate, and treatment group, visit, treatment group-by-visit interaction, and baseline-by-visit interaction as fixed effects. Participant was included as a random effect.||-1.95|-4.37|<0.0001
72419420|NCT04102579|144349296|OTHER||Percent Difference in Responders|29.65||||0.0007|TWO_SIDED|95.0|10.77|45.37||Statistical significance achieved if p-value \<0.05.|Fisher Exact||Percent Difference in Responders (%) = Valbenazine - Placebo|||45.37|10.77|0.0007
72419421|NCT04102579|144349297|OTHER||Percent Difference in Responders|26.31||||0.0062|TWO_SIDED|95.0|6.32|43.74||Statistical significance achieved if p-value \<0.05.|Fisher Exact||Percent Difference in Responders (%) = Valbenazine - Placebo|||43.74|6.32|0.0062
72419422|NCT04102579|144349298|OTHER||LS Means Difference|1.42|STANDARD_ERROR_OF_MEAN|1.46||0.3304|TWO_SIDED|95.0|-1.46|4.31||Statistical significance achieved if p-value \<0.05.|MMRM||LS Means Difference = Valbenazine - Placebo|LS mean was based on the MMRM model which included corresponding baseline value of the Neuro-QoL Upper Extremity Function T-score as a covariate; treatment group, visit, baseline-by-visit interaction, and treatment group-by-visit interaction as fixed effects; and participant as a random effect.||4.31|-1.46|0.3304
72419423|NCT01077830|144349316|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.33|||||TWO_SIDED|95.0|0.84|2.09|||Regression, Cox||Hazard Ratio obtained by dividing the crude rate of death (any cause) reported in the Ezetimibe/Simvastatin 10/40 arm by the crude rate of death (any cause) in the Placebo arm|||2.09|0.84|
72419424|NCT01077830|144349317|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.36|||||TWO_SIDED|95.0|0.3|6.06|||||Hazard Ratio obtained by dividing the crude rate of death from cancer reported in the Ezetimibe/Simvastatin 10/40 arm by the crude rate of death from cancer in the Placebo arm|||6.06|0.30|
72612334|NCT03620162|144753401|OTHER|Estimated differences, CIs, and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percentage|-1.6|||=|0.527|TWO_SIDED|95.0|-7.1|3.7|||Miettinen & Nurminen method|||Difference in Percentage: Hives(Group 3 vs 1)||3.7|-7.1|= 0.527
72612335|NCT03620162|144753401|OTHER|Estimated differences, CIs, and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percentage|-3.4|||=|0.16|TWO_SIDED|95.0|-8.6|1.5|||Miettinen & Nurminen method|||Difference in Percentage: Hives(Group 2 vs 1)||1.5|-8.6|= 0.160
72612336|NCT03620162|144753402|OTHER|Estimated differences and CIs are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percentage|0.0|||||TWO_SIDED|95.0|-2.1|2.1||||||Difference in Percentage (Group 5 vs 1)||2.1|-2.1|
72612337|NCT03620162|144753402|OTHER|Estimated differences and CIs are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percentage|0.0|||||TWO_SIDED|95.0|-2.1|2.1||||||Difference in Percentage (Group 4 vs 1)||2.1|-2.1|
72612338|NCT03620162|144753402|OTHER|Estimated differences and CIs are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percentage|0.6|||||TWO_SIDED|95.0|-1.6|3.1||||||Difference in Percentage (Group 3 vs 1)||3.1|-1.6|
72612339|NCT03620162|144753402|OTHER|Estimated differences and CIs are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percentage|0.0|||||TWO_SIDED|95.0|-2.1|2.1||||||Difference in Percentage (Group 2 vs 1)||2.1|-2.1|
72612340|NCT03620162|144753403|OTHER|GMC ratio and CI are estimated from a serotype-specific ANCOVA model utilizing the natural log-transformed antibody concentration as the response and vaccination group and stratification factor as covariates.|GMC Ratio|0.83|||||TWO_SIDED|95.0|0.69|1.0||||||GMC Ratio: Serotype 1 (Group 4 vs 1)||1.00|0.69|
72612341|NCT03620162|144753403|OTHER|GMC ratio and CI are estimated from a serotype-specific ANCOVA model utilizing the natural log-transformed antibody concentration as the response and vaccination group and stratification factor as covariates.|GMC Ratio|0.93|||||TWO_SIDED|95.0|0.77|1.12||||||GMC Ratio: Serotype 1 (Group 3 vs 1)||1.12|0.77|
72612342|NCT03620162|144753403|OTHER|GMC ratio and CI are estimated from a serotype-specific ANCOVA model utilizing the natural log-transformed antibody concentration as the response and vaccination group and stratification factor as covariates.|GMC Ratio|0.83|||||TWO_SIDED|95.0|0.7|1.0||||||GMC Ratio: Serotype 1 (Group 2 vs 1)||1.00|0.70|
72612343|NCT03620162|144753403|OTHER|GMC ratio and CI are estimated from a serotype-specific ANCOVA model utilizing the natural log-transformed antibody concentration as the response and vaccination group and stratification factor as covariates.|GMC Ratio|1.01|||||TWO_SIDED|95.0|0.86|1.19||||||GMC Ratio: Serotype 3 (Group 4 vs 1)||1.19|0.86|
72612344|NCT03620162|144753403|OTHER|GMC ratio and CI are estimated from a serotype-specific ANCOVA model utilizing the natural log-transformed antibody concentration as the response and vaccination group and stratification factor as covariates.|GMC Ratio|0.94|||||TWO_SIDED|95.0|0.8|1.12||||||GMC Ratio: Serotype 3 (Group 3 vs 1)||1.12|0.80|
72612345|NCT03620162|144753403|OTHER|GMC ratio and CI are estimated from a serotype-specific ANCOVA model utilizing the natural log-transformed antibody concentration as the response and vaccination group and stratification factor as covariates.|GMC Ratio|1.06|||||TWO_SIDED|95.0|0.9|1.25||||||GMC Ratio: Serotype 3 (Group 2 vs 1)||1.25|0.90|
72612346|NCT03620162|144753403|OTHER|GMC ratio and CI are estimated from a serotype-specific ANCOVA model utilizing the natural log-transformed antibody concentration as the response and vaccination group and stratification factor as covariates.|GMC Ratio|0.81|||||TWO_SIDED|95.0|0.66|1.0||||||GMC Ratio: Serotype 4 (Group 4 vs 1)||1.00|0.66|
72612347|NCT03620162|144753403|OTHER|GMC ratio and CI are estimated from a serotype-specific ANCOVA model utilizing the natural log-transformed antibody concentration as the response and vaccination group and stratification factor as covariates.|GMC Ratio|0.84|||||TWO_SIDED|95.0|0.68|1.03||||||GMC Ratio: Serotype 4 (Group 3 vs 1)||1.03|0.68|
72612348|NCT03620162|144753403|OTHER|GMC ratio and CI are estimated from a serotype-specific ANCOVA model utilizing the natural log-transformed antibody concentration as the response and vaccination group and stratification factor as covariates.|GMC Ratio|0.88|||||TWO_SIDED|95.0|0.72|1.08||||||GMC Ratio: Serotype 4 (Group 2 vs 1)||1.08|0.72|
72612349|NCT03620162|144753403|OTHER|GMC ratio and CI are estimated from a serotype-specific ANCOVA model utilizing the natural log-transformed antibody concentration as the response and vaccination group and stratification factor as covariates.|GMC Ratio|0.79|||||TWO_SIDED|95.0|0.64|0.98||||||GMC Ratio: Serotype 5 (Group 4 vs 1)||0.98|0.64|
72612350|NCT03620162|144753403|OTHER|GMC ratio and CI are estimated from a serotype-specific ANCOVA model utilizing the natural log-transformed antibody concentration as the response and vaccination group and stratification factor as covariates.|GMC Ratio|1.04|||||TWO_SIDED|95.0|0.84|1.29||||||GMC Ratio: Serotype 5 (Group 3 vs 1)||1.29|0.84|
72612351|NCT03620162|144753403|OTHER|GMC ratio and CI are estimated from a serotype-specific ANCOVA model utilizing the natural log-transformed antibody concentration as the response and vaccination group and stratification factor as covariates.|GMC Ratio|0.92|||||TWO_SIDED|95.0|0.75|1.14||||||GMC Ratio: Serotype 5 (Group 2 vs 1)||1.14|0.75|
72612352|NCT03620162|144753403|OTHER|GMC ratio and CI are estimated from a serotype-specific ANCOVA model utilizing the natural log-transformed antibody concentration as the response and vaccination group and stratification factor as covariates.|GMC Ratio|0.8|||||TWO_SIDED|95.0|0.66|0.98||||||GMC Ratio: Serotype 6A (Group 4 vs 1)||0.98|0.66|
72612353|NCT03620162|144753403|OTHER|GMC ratio and CI are estimated from a serotype-specific ANCOVA model utilizing the natural log-transformed antibody concentration as the response and vaccination group and stratification factor as covariates.|GMC Ratio|1.11|||||TWO_SIDED|95.0|0.91|1.37||||||GMC Ratio: Serotype 6A (Group 3 vs 1)||1.37|0.91|
72612354|NCT03620162|144753403|OTHER|GMC ratio and CI are estimated from a serotype-specific ANCOVA model utilizing the natural log-transformed antibody concentration as the response and vaccination group and stratification factor as covariates.|GMC Ratio|1.12|||||TWO_SIDED|95.0|0.92|1.36||||||GMC Ratio: Serotype 6A (Group 2 vs 1)||1.36|0.92|
72326784|NCT01490918|144176872|SUPERIORITY|||||||0.314||||||The threshold for statistical significance was p=0.05|ANCOVA|baseline data as covariate||||||0.314
72612355|NCT03620162|144753403|OTHER|GMC ratio and CI are estimated from a serotype-specific ANCOVA model utilizing the natural log-transformed antibody concentration as the response and vaccination group and stratification factor as covariates.|GMC Ratio|1.08|||||TWO_SIDED|95.0|0.88|1.31||||||GMC Ratio: Serotype 6B (Group 4 vs 1)||1.31|0.88|
72612356|NCT03620162|144753403|OTHER|GMC ratio and CI are estimated from a serotype-specific ANCOVA model utilizing the natural log-transformed antibody concentration as the response and vaccination group and stratification factor as covariates.|GMC Ratio|1.08|||||TWO_SIDED|95.0|0.88|1.32||||||GMC Ratio: Serotype 6B (Group 3 vs 1)||1.32|0.88|
72612357|NCT03620162|144753403|OTHER|GMC ratio and CI are estimated from a serotype-specific ANCOVA model utilizing the natural log-transformed antibody concentration as the response and vaccination group and stratification factor as covariates.|GMC Ratio|1.23|||||TWO_SIDED|95.0|1.02|1.49||||||GMC Ratio: Serotype 6B (Group 2 vs 1)||1.49|1.02|
72612358|NCT03620162|144753403|OTHER|GMC ratio and CI are estimated from a serotype-specific ANCOVA model utilizing the natural log-transformed antibody concentration as the response and vaccination group and stratification factor as covariates.|GMC Ratio|0.78|||||TWO_SIDED|95.0|0.64|0.95||||||GMC Ratio: Serotype 7F (Group 4 vs 1)||0.95|0.64|
72612359|NCT03620162|144753403|OTHER|GMC ratio and CI are estimated from a serotype-specific ANCOVA model utilizing the natural log-transformed antibody concentration as the response and vaccination group and stratification factor as covariates.|GMC Ratio|0.99|||||TWO_SIDED|95.0|0.81|1.21||||||GMC Ratio: Serotype 7F (Group 3 vs 1)||1.21|0.81|
72612360|NCT03620162|144753403|OTHER|GMC ratio and CI are estimated from a serotype-specific ANCOVA model utilizing the natural log-transformed antibody concentration as the response and vaccination group and stratification factor as covariates.|GMC Ratio|1.11|||||TWO_SIDED|95.0|0.92|1.35||||||GMC Ratio: Serotype 7F (Group 2 vs 1)||1.35|0.92|
72612361|NCT03620162|144753403|OTHER|GMC ratio and CI are estimated from a serotype-specific ANCOVA model utilizing the natural log-transformed antibody concentration as the response and vaccination group and stratification factor as covariates.|GMC Ratio|0.84|||||TWO_SIDED|95.0|0.7|1.01||||||GMC Ratio: Serotype 9V (Group 4 vs 1)||1.01|0.70|
72612362|NCT03620162|144753403|OTHER|GMC ratio and CI are estimated from a serotype-specific ANCOVA model utilizing the natural log-transformed antibody concentration as the response and vaccination group and stratification factor as covariates.|GMC Ratio|0.88|||||TWO_SIDED|95.0|0.73|1.06||||||GMC Ratio: Serotype 9V (Group 3 vs 1)||1.06|0.73|
72612363|NCT03620162|144753403|OTHER|GMC ratio and CI are estimated from a serotype-specific ANCOVA model utilizing the natural log-transformed antibody concentration as the response and vaccination group and stratification factor as covariates.|GMC Ratio|0.94|||||TWO_SIDED|95.0|0.79|1.13||||||GMC Ratio: Serotype 9V (Group 2 vs 1)||1.13|0.79|
72612364|NCT03620162|144753403|OTHER|GMC ratio and CI are estimated from a serotype-specific ANCOVA model utilizing the natural log-transformed antibody concentration as the response and vaccination group and stratification factor as covariates.|GMC Ratio|1.03|||||TWO_SIDED|95.0|0.83|1.28||||||GMC Ratio: Serotype 14 (Group 4 vs 1)||1.28|0.83|
72612365|NCT03620162|144753403|OTHER|GMC ratio and CI are estimated from a serotype-specific ANCOVA model utilizing the natural log-transformed antibody concentration as the response and vaccination group and stratification factor as covariates.|GMC Ratio|1.43|||||TWO_SIDED|95.0|1.15|1.78||||||GMC Ratio: Serotype 14 (Group 3 vs 1)||1.78|1.15|
72612366|NCT03620162|144753403|OTHER|GMC ratio and CI are estimated from a serotype-specific ANCOVA model utilizing the natural log-transformed antibody concentration as the response and vaccination group and stratification factor as covariates.|GMC Ratio|1.39|||||TWO_SIDED|95.0|1.13|1.71||||||GMC Ratio: Serotype 14 (Group 2 vs 1)||1.71|1.13|
72612367|NCT03620162|144753403|OTHER|GMC ratio and CI are estimated from a serotype-specific ANCOVA model utilizing the natural log-transformed antibody concentration as the response and vaccination group and stratification factor as covariates.|GMC Ratio|1.07|||||TWO_SIDED|95.0|0.88|1.3||||||GMC Ratio: Serotype 18C (Group 4 vs 1)||1.30|0.88|
72612368|NCT03620162|144753403|OTHER|GMC ratio and CI are estimated from a serotype-specific ANCOVA model utilizing the natural log-transformed antibody concentration as the response and vaccination group and stratification factor as covariates.|GMC Ratio|1.44|||||TWO_SIDED|95.0|1.18|1.76||||||GMC Ratio: Serotype 18C (Group 3 vs 1)||1.76|1.18|
72612369|NCT03620162|144753403|OTHER|GMC ratio and CI are estimated from a serotype-specific ANCOVA model utilizing the natural log-transformed antibody concentration as the response and vaccination group and stratification factor as covariates.|GMC Ratio|1.51|||||TWO_SIDED|95.0|1.25|1.83||||||GMC Ratio: Serotype 18C (Group 2 vs 1)||1.83|1.25|
72612370|NCT03620162|144753403|OTHER|GMC ratio and CI are estimated from a serotype-specific ANCOVA model utilizing the natural log-transformed antibody concentration as the response and vaccination group and stratification factor as covariates.|GMC Ratio|0.84|||||TWO_SIDED|95.0|0.69|1.01||||||GMC Ratio: Serotype 19A (Group 4 vs 1)||1.01|0.69|
72612371|NCT03620162|144753403|OTHER|GMC ratio and CI are estimated from a serotype-specific ANCOVA model utilizing the natural log-transformed antibody concentration as the response and vaccination group and stratification factor as covariates.|GMC Ratio|0.88|||||TWO_SIDED|95.0|0.72|1.07||||||GMC Ratio: Serotype 19A (Group 3 vs 1)||1.07|0.72|
72612372|NCT03620162|144753403|OTHER|GMC ratio and CI are estimated from a serotype-specific ANCOVA model utilizing the natural log-transformed antibody concentration as the response and vaccination group and stratification factor as covariates.|GMC Ratio|0.93|||||TWO_SIDED|95.0|0.77|1.13||||||GMC Ratio: Serotype 19A (Group 2 vs 1)||1.13|0.77|
72612373|NCT03620162|144753403|OTHER|GMC ratio and CI are estimated from a serotype-specific ANCOVA model utilizing the natural log-transformed antibody concentration as the response and vaccination group and stratification factor as covariates.|GMC Ratio|0.96|||||TWO_SIDED|95.0|0.81|1.15||||||GMC Ratio: Serotype 19F (Group 4 vs 1)||1.15|0.81|
72612374|NCT03620162|144753403|OTHER|GMC ratio and CI are estimated from a serotype-specific ANCOVA model utilizing the natural log-transformed antibody concentration as the response and vaccination group and stratification factor as covariates.|GMC Ratio|1.05|||||TWO_SIDED|95.0|0.88|1.26||||||GMC Ratio: Serotype 19F (Group 3 vs 1)||1.26|0.88|
72612375|NCT03620162|144753403|OTHER|GMC ratio and CI are estimated from a serotype-specific ANCOVA model utilizing the natural log-transformed antibody concentration as the response and vaccination group and stratification factor as covariates.|GMC Ratio|1.02|||||TWO_SIDED|95.0|0.86|1.21||||||GMC Ratio: Serotype 19F (Group 2 vs 1)||1.21|0.86|
72419425|NCT01077830|144349318|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.55|||||TWO_SIDED|95.0|0.27|1.11|||||Hazard Ratio obtained by dividing the crude rate of new cancers reported in the Ezetimibe/Simvastatin 10/40 arm by the crude rate of newly diagnosed cancers in the the Placebo arm|||1.11|0.27|
72326785|NCT01490918|144176873|SUPERIORITY|||||||0.7563||||||The threshold for statistical significance was p=0.05|ANCOVA|baseline data as covariate||||||0.7563
72326786|NCT03141255|144176875|OTHER|||||||1|||||||Fisher Exact|||||||1
72326787|NCT03141255|144176876|SUPERIORITY|||||||0.47|||||||Fisher Exact|||||||0.47
72326788|NCT03141255|144176877|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1
72326789|NCT03141255|144176878|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1
72612376|NCT03620162|144753403|OTHER|GMC ratio and CI are estimated from a serotype-specific ANCOVA model utilizing the natural log-transformed antibody concentration as the response and vaccination group and stratification factor as covariates.|GMC Ratio|0.77|||||TWO_SIDED|95.0|0.61|0.96||||||GMC Ratio: Serotype 23F (Group 4 vs 1)||0.96|0.61|
72612377|NCT03620162|144753403|OTHER|GMC ratio and CI are estimated from a serotype-specific ANCOVA model utilizing the natural log-transformed antibody concentration as the response and vaccination group and stratification factor as covariates.|GMC Ratio|0.79|||||TWO_SIDED|95.0|0.63|0.99||||||GMC Ratio: Serotype 23F (Group 3 vs 1)||0.99|0.63|
72612378|NCT03620162|144753403|OTHER|GMC ratio and CI are estimated from a serotype-specific ANCOVA model utilizing the natural log-transformed antibody concentration as the response and vaccination group and stratification factor as covariates.|GMC Ratio|0.94|||||TWO_SIDED|95.0|0.76|1.17||||||GMC Ratio: Serotype 23F (Group 2 vs 1)||1.17|0.76|
72612379|NCT03620162|144753404|NON_INFERIORITY|The statistical criterion for non-inferiority requires the lower bound of the 2-sided 95% CI for the difference in percentages (Group 5/Group 1+Group 2) to be \>-10 percentage points.|Difference in Percentage|-0.2|||<|0.001|TWO_SIDED|95.0|-3.7|2.0|||Miettinen & Nurminen method|||Difference in Percentage (Group 5 vs Group 1+2)||2.0|-3.7|< 0.001
72612380|NCT03620162|144753405|NON_INFERIORITY|The statistical criterion for non-inferiority requires the lower bound of the 2-sided 95% CI for the GMT ratio (Group 5/Group 1+Group 2) to be \>0.5.|GMT Ratio|0.97|||<|0.001|TWO_SIDED|95.0|0.7|1.34|||ANCOVA|||GMT Ratio (Group 5 vs Group 1+2)||1.34|0.70|< 0.001
72612381|NCT03620162|144753408|OTHER|GMC ratio and CI are estimated from a serotype-specific ANCOVA model utilizing the natural log-transformed antibody concentration as the response and vaccination group and stratification factor as covariates.|GMC Ratio|0.72|||||TWO_SIDED|95.0|0.6|0.86||||||GMC Ratio: Serotype 1 (Group 5 vs 1)||0.86|0.60|
72612382|NCT03620162|144753408|OTHER|GMC ratio and CI are estimated from a serotype-specific ANCOVA model utilizing the natural log-transformed antibody concentration as the response and vaccination group and stratification factor as covariates.|GMC Ratio|1.22|||||TWO_SIDED|95.0|1.04|1.44||||||GMC Ratio: Serotype 3 (Group 5 vs 1)||1.44|1.04|
72612383|NCT03620162|144753408|OTHER|GMC ratio and CI are estimated from a serotype-specific ANCOVA model utilizing the natural log-transformed antibody concentration as the response and vaccination group and stratification factor as covariates.|GMC Ratio|0.89|||||TWO_SIDED|95.0|0.73|1.1||||||GMC Ratio: Serotype 4 (Group 5 vs 1)||1.10|0.73|
72612384|NCT03620162|144753408|OTHER|GMC ratio and CI are estimated from a serotype-specific ANCOVA model utilizing the natural log-transformed antibody concentration as the response and vaccination group and stratification factor as covariates.|GMC Ratio|0.79|||||TWO_SIDED|95.0|0.64|0.97||||||GMC Ratio: Serotype 5 (Group 5 vs 1)||0.97|0.64|
72612385|NCT03620162|144753408|OTHER|GMC ratio and CI are estimated from a serotype-specific ANCOVA model utilizing the natural log-transformed antibody concentration as the response and vaccination group and stratification factor as covariates.|GMC Ratio|0.69|||||TWO_SIDED|95.0|0.57|0.84||||||GMC Ratio: Serotype 6A (Group 5 vs 1)||0.84|0.57|
72612386|NCT03620162|144753408|OTHER|GMC ratio and CI are estimated from a serotype-specific ANCOVA model utilizing the natural log-transformed antibody concentration as the response and vaccination group and stratification factor as covariates.|GMC Ratio|0.95|||||TWO_SIDED|95.0|0.78|1.15||||||GMC Ratio: Serotype 6B (Group 5 vs 1)||1.15|0.78|
72612387|NCT03620162|144753408|OTHER|GMC ratio and CI are estimated from a serotype-specific ANCOVA model utilizing the natural log-transformed antibody concentration as the response and vaccination group and stratification factor as covariates.|GMC Ratio|0.67|||||TWO_SIDED|95.0|0.55|0.82||||||GMC Ratio: Serotype 7F (Group 5 vs 1)||0.82|0.55|
72612388|NCT03620162|144753408|OTHER|GMC ratio and CI are estimated from a serotype-specific ANCOVA model utilizing the natural log-transformed antibody concentration as the response and vaccination group and stratification factor as covariates.|GMC Ratio|0.99|||||TWO_SIDED|95.0|0.82|1.18||||||GMC Ratio: Serotype 9V (Group 5 vs 1)||1.18|0.82|
72612389|NCT03620162|144753408|OTHER|GMC ratio and CI are estimated from a serotype-specific ANCOVA model utilizing the natural log-transformed antibody concentration as the response and vaccination group and stratification factor as covariates.|GMC Ratio|0.86|||||TWO_SIDED|95.0|0.7|1.07||||||GMC Ratio: Serotype 14 (Group 5 vs 1)||1.07|0.70|
72612390|NCT03620162|144753408|OTHER|GMC ratio and CI are estimated from a serotype-specific ANCOVA model utilizing the natural log-transformed antibody concentration as the response and vaccination group and stratification factor as covariates.|GMC Ratio|1.03|||||TWO_SIDED|95.0|0.85|1.25||||||GMC Ratio: Serotype 18C (Group 5 vs 1)||1.25|0.85|
72612391|NCT03620162|144753408|OTHER|GMC ratio and CI are estimated from a serotype-specific ANCOVA model utilizing the natural log-transformed antibody concentration as the response and vaccination group and stratification factor as covariates.|GMC Ratio|0.79|||||TWO_SIDED|95.0|0.65|0.95||||||GMC Ratio: Serotype 19A (Group 5 vs 1)||0.95|0.65|
72612392|NCT03620162|144753408|OTHER|GMC ratio and CI are estimated from a serotype-specific ANCOVA model utilizing the natural log-transformed antibody concentration as the response and vaccination group and stratification factor as covariates.|GMC Ratio|0.86|||||TWO_SIDED|95.0|0.72|1.02||||||GMC Ratio: Serotype 19F (Group 5 vs 1)||1.02|0.72|
72326790|NCT03141255|144176879|SUPERIORITY|||||||0.029|||||||Mixed Models Analysis|||||||0.029
72612393|NCT03620162|144753408|OTHER|GMC ratio and CI are estimated from a serotype-specific ANCOVA model utilizing the natural log-transformed antibody concentration as the response and vaccination group and stratification factor as covariates.|GMC Ratio|0.73|||||TWO_SIDED|95.0|0.59|0.91||||||GMC Ratio: Serotype 23F (Group 5 vs 1)||0.91|0.59|
72612394|NCT03416179|144753410|SUPERIORITY||Hazard Ratio (HR)|1.08||||0.6579|TWO_SIDED|95.0|0.755|1.532|||Log Rank|||Hazard ratio based on Cox proportional hazards model; under proportional hazards, hazard ratio less than (\<) 1 indicated a reduction in hazard rate in favor of Glasdegib 100 mg PO + Cytarabine 100 mg/m\^2 IV + Daunorubicin 60 mg/m\^2 compared to Placebo + Cytarabine 100 mg/m\^2 IV + Daunorubicin 60 mg/m\^2.||1.532|0.755|0.6579
72612395|NCT03416179|144753411|SUPERIORITY||Hazard Ratio (HR)|1.04||||0.5955|TWO_SIDED|95.0|0.775|1.388|||Log Rank|||Hazard ratio based on Cox proportional hazards model; under proportional hazards, hazard ratio \< 1 indicated a reduction in hazard rate in favor of Glasdegib 100 mg PO QD + Azacitidine compared to Placebo + Azacitidine||1.388|0.775|0.5955
72612396|NCT03416179|144753412|OTHER|||||||0.5095|||||||Mantel Haenszel|||||||0.5095
72612397|NCT03416179|144753413|OTHER|||||||0.8359|||||||Mantel Haenszel|||||||0.8359
72612398|NCT02164916|144753472|SUPERIORITY||Hazard Ratio (HR)|0.48||||0.001|TWO_SIDED|95.0|0.31|0.75|||Log Rank|||||0.75|0.31|0.001
72612399|NCT01101178|144753505|NON_INFERIORITY_OR_EQUIVALENCE|A mixed-model analysis of variance was used to compare (test vs reference) and the 90% confidence intervals were estimated for the ratios (test/reference)|Geometric Test/Ref Ratio x 100|110.0|||||TWO_SIDED|90.0|105.21|114.47|||ANOVA||Bioequivalence was established when 90% Confidence Interval fell within 80%-125%.|||114.47|105.21|
72612400|NCT01101178|144753506|NON_INFERIORITY_OR_EQUIVALENCE|A mixed-model analysis of variance was used to compare (test vs reference) and the 90% confidence intervals were estimated for the ratios (test/reference)|Geometric Test/Ref Ratio x 100|94.7|||||TWO_SIDED|90.0|92.71|96.64|||ANOVA||Bioequivalence was established when 90% Confidence Interval fell within 80%-125%.|||96.64|92.71|
72612401|NCT01101178|144753507|NON_INFERIORITY_OR_EQUIVALENCE|A mixed-model analysis of variance was used to compare (test vs reference) and the 90% confidence intervals were estimated for the ratios (test/reference)|Geometric Test/Ref Ratio x 100|94.9|||||TWO_SIDED|90.0|92.9|97.02|||ANOVA||Bioequivalence is established when 90% Confidence Interval falls within 80%-125%.|||97.02|92.90|
72612402|NCT00846365|144753532|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.1|||<|0.001|TWO_SIDED|95.0|-8.4|-3.8||Statistical significance was set at the 0.05 level per the predefined stepwise testing strategy used.|ANCOVA|||Analysis of Covariance (ANCOVA) model with treatment as a fixed effect and Baseline as a covariate.||-3.8|-8.4|<0.001
72612403|NCT00846365|144753532|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.7|||<|0.001|TWO_SIDED|95.0|-9.1|-4.4||Statistical significance was set at the 0.05 level per the predefined stepwise testing strategy used.|ANCOVA|||ANCOVA model with treatment as a fixed effect and Baseline as a covariate.||-4.4|-9.1|<0.001
72612404|NCT00846365|144753533|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.1|||<|0.001|TWO_SIDED|95.0|-8.5|-3.7||Statistical significance was set at the 0.05 level per the predefined stepwise testing strategy used.|ANCOVA|||ANCOVA model with treatment as a fixed effect and Baseline as a covariate.||-3.7|-8.5|<0.001
72612405|NCT00846365|144753533|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-7.2|||<|0.001|TWO_SIDED|95.0|-9.6|-4.8||Statistical significance was set at the 0.05 level per the predefined stepwise testing strategy used.|ANCOVA|||ANCOVA model with treatment as a fixed effect and Baseline as a covariate.||-4.8|-9.6|<0.001
72612406|NCT00846365|144753537|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.6|||<|0.001|TWO_SIDED|95.0|-7.5|-3.7||Tested at the 0.05 significance level.|ANCOVA|||Statistical analysis for Week 8. ANOVA model with treatment as a fixed effect. Post-baseline p-values are obtained from an ANCOVA model with treatment as a fixed effect and baseline as a covariate.||-3.7|-7.5|<0.001
72326791|NCT03141255|144176880|SUPERIORITY|||||||0.091|||||||Mixed Models Analysis|||||||0.091
72326792|NCT03141255|144176881|SUPERIORITY|||||||0.029|||||||Mixed Models Analysis|||||||0.029
72326793|NCT03141255|144176882|SUPERIORITY|||||||0.7|||||||t-test, 2 sided|||||||0.7
72612407|NCT00846365|144753537|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.2|||<|0.001|TWO_SIDED|95.0|-9.1|-5.2||Tested at the 0.05 significance level.|ANCOVA|||Statistical analysis for Week 8. ANOVA model with treatment as a fixed effect. Post-baseline p-values are obtained from an ANCOVA model with treatment as a fixed effect and baseline as a covariate.||-5.2|-9.1|<0.001
72612408|NCT03479905|144753553|SUPERIORITY|||||||0.0004|||||||Kruskal-Wallis|||||||0.0004
72612409|NCT00720759|144753554|SUPERIORITY_OR_OTHER||Slope|0.83|STANDARD_ERROR_OF_MEAN|8.54|<|0.05|TWO_SIDED|95.0|||||Regression, Linear|||A general linear model was employed. The independent variables were baseline WMFT score, treatment (condensed vs distributed), treatment (d-cycloserine vs placebo), and treatment interaction effect. The dependent measure was WMFT score at 3 months post treatment.||||<0.05
72612410|NCT03857256|144753590|SUPERIORITY|Mean changes from Week 0 in LDL-C were analyzed using a restricted maximum likelihood (REML)-based repeated measures approach including effects of treatment group, time (Week 6 and Week 12) and treatment group x time interaction as well as the covariates of Week 0 value of LDL-C and Week 0 value of LDL-C x time interaction. An unstructured covariance structure were used to model the within-patient errors. Contrasts under this model allowed for the three main comparisons.||||||0.0167||||||Tests involving the comparisons of each of the active groups versus placebo for the primary endpoint were conducted at the 0.0167 significance level (to account for three main comparisons).|Mixed Models Analysis|The Kenward-Roger approximation were used to estimate denominator degrees of freedom.||Tests involving the comparisons of each of the active groups versus placebo for the primary endpoint were conducted at the 0.0167 significance level (to account for three main comparisons).||||0.0167
72612411|NCT03643848|144753619|SUPERIORITY||variance components; inferring mean diff|0.068|STANDARD_DEVIATION|0.033|<|0.046|TWO_SIDED|||||a priori threshold p\<.05|Mixed Models Analysis|REML; Satterwaite method for t-tests.Participant is random effect. Addtnl fixed effects: Valence, Condition, Anxiety Severity, Gender, Age (months).||Condition (TMR, Sham) x Valence (Negative, Neutral) predicting Lure Generalization Index at 1 week. We hypothesized a significant interaction, with a reduction in negative generalization and an increase in neutral generalization in the TMR condition.||||<.046
72552594|NCT01015625|144636039|SUPERIORITY|A two-sided significance level of 5% was used.|Cox Proportional Hazard|1.77||||0.042|TWO_SIDED|95.0|1.01|3.09|||Log Rank||From the Cox Proportional hazard model with surgery vs no surgery fitted as a covariate. A hazard ratio \> 1.0 indicates a higher average event rate and a shorter overall survival time for surgery relative to no surgery.|To determine the effect of local therapy (surgery, Arm A) compared to systemic therapy only (Arm B) in synchronous metastasized breast cancer patients in terms of overall survival. Overall survival is defined as the time from randomization to death from any cause. Participants last known to be alive were censored at their last contact date or at the data cut-off date whichever came first.||3.09|1.01|0.042
72612412|NCT03643848|144753620|SUPERIORITY||variance components; inferring mean diff|-0.033|STANDARD_ERROR_OF_MEAN|0.064|=|0.61|TWO_SIDED|||||a priori p\<.05|Mixed Models Analysis|included additional fixed effects: Anxiety severity, gender, age (months)||Condition (TMR, Sham) x Valence (Negative, Neutral) predicting Lure Generalization Index at 12 hour test. We hypothesized a significant interaction, with a reduction in negative generalization and an increase in neutral generalization in the TMR condition.||||=.61
72612413|NCT04761822|144753621|SUPERIORITY||Risk Difference (RD)|0.026||||0.066|TWO_SIDED|95.0|-0.002|0.06||Two-sided test using the central method of doubling the one-sided p-value.|Barnard's Exact Unconditional Test|||The null hypothesis is that the risk difference, where the difference is represented as the high allergy/mast cell disorder cohort proportion minus comparison cohort proportion, is not statistically different from 0 (i.e. there is no difference).||0.060|-0.002|0.066
72612414|NCT04761822|144753622|SUPERIORITY||Risk Difference (RD)|0.012||||0.267|TWO_SIDED|95.0|-0.016|0.042||Two-sided test using the central method of doubling the one-sided p-value.|Barnard's Exact Unconditional Test|||The null hypothesis is that the risk difference, where the difference is represented as the high allergy/mast cell disorder cohort proportion minus comparison cohort proportion, is not statistically different from 0 (i.e. there is no difference).||0.042|-0.016|0.267
72612415|NCT04761822|144753623|SUPERIORITY||Risk Difference (RD)|0.016||||0.165|TWO_SIDED|95.0|-0.011|0.046||Two-sided test using the central method of doubling the one-sided p-value.|Barnard's Exact Unconditional Test|||The null hypothesis is that the risk difference, where the difference is represented as the high allergy/mast cell disorder cohort proportion minus comparison cohort proportion, is not statistically different from 0 (i.e. there is no difference).||0.046|-0.011|0.165
72612416|NCT04761822|144753624|SUPERIORITY||Risk Difference (RD)|0.006||||0.572|TWO_SIDED|95.0|-0.021|0.033||Two-sided test using the central method of doubling the one-sided p-value.|Barnard's Exact Unconditional Test|||The null hypothesis is that the risk difference, where the difference is represented as the high allergy/mast cell disorder cohort proportion minus comparison cohort proportion, is not statistically different from 0 (i.e. there is no difference).||0.033|-0.021|0.572
72612417|NCT04761822|144753625|SUPERIORITY||Risk Difference (RD)|0.016||||0.165|TWO_SIDED|95.0|-0.011|0.046|||Barnard's Exact Unconditional Test|||The null hypothesis is that the risk difference, where the difference is represented as the high allergy/mast cell disorder cohort proportion minus comparison cohort proportion, is not statistically different from 0 (i.e. there is no difference).||0.046|-0.011|0.165
72612418|NCT04761822|144753626|SUPERIORITY||Risk Difference (RD)|0.006||||0.572|TWO_SIDED|95.0|-0.021|0.033||Two-sided test using the central method of doubling the one-sided p-value.|Barnard's Exact Unconditional Test|||The null hypothesis is that the risk difference, where the difference is represented as the high allergy/mast cell disorder cohort proportion minus comparison cohort proportion, is not statistically different from 0 (i.e. there is no difference).||0.033|-0.021|0.572
72612419|NCT04761822|144753627|SUPERIORITY||Risk Difference (RD)|0.015||||0.4574|TWO_SIDED|95.0|-0.045|0.055||Two-sided test using the central method of doubling the one-sided p-value.|Barnard's Exact Unconditional Test|||The null hypothesis is that the risk difference, where the difference is represented as the participants that received their first active dose as their first injection proportion minus the participants that received their first active dose as their second injection proportion, is not statistically different from 0 (i.e. there is no difference).||0.055|-0.045|0.4574
72612420|NCT04761822|144753628|SUPERIORITY||Risk Difference (RD)|-0.016||||0.3242|TWO_SIDED|95.0|-0.086|0.018||Two-sided test using the central method of doubling the one-sided p-value.|Barnard's Exact Unconditional Test|||The null hypothesis is that the risk difference, where the difference is represented as the participants that received their first active dose as their first injection proportion minus the participants that received their first active dose as their second injection proportion, is not statistically different from 0 (i.e. there is no difference).||0.018|-0.086|0.3242
72612421|NCT04761822|144753629|SUPERIORITY||Risk Difference (RD)|0.024||||0.31|TWO_SIDED|95.0|-0.037|0.07||Two-sided test using the central method of doubling the one-sided p-value.|Barnard's Exact Unconditional Test|||The null hypothesis is that the risk difference, where the difference is represented as the participants that received their second active dose as their second injection proportion minus the participants that received their second active dose as their third injection proportion, is not statistically different from 0 (i.e. there is no difference).||0.070|-0.037|0.3100
72612422|NCT04761822|144753630|SUPERIORITY||Risk Difference (RD)|-0.007||||0.807|TWO_SIDED|95.0|-0.0783|0.0366||Two-sided test using the central method of doubling the one-sided p-value.|Barnard's Exact Unconditional Test|||The null hypothesis is that the risk difference, where the difference is represented as the participants that received their second active dose as their second injection proportion minus the participants that received their second active dose as their third injection proportion, is not statistically different from 0 (i.e. there is no difference).||0.0366|-0.0783|0.8070
72612423|NCT04761822|144753631|SUPERIORITY||Risk Difference (RD)|0.001||||1|TWO_SIDED|95.0|-0.04|0.042||Two-sided test using the central method of doubling the one-sided p-value.|Barnard's Exact Unconditional Test|||The null hypothesis is that the risk difference, where the difference is represented as the Pfizer-BioNTech COVID-19 vaccine first injection proportion minus comparison placebo first injection proportion, is not statistically different from 0 (i.e. there is no difference).||0.042|-0.040|1.000
72612424|NCT04761822|144753632|SUPERIORITY||Risk Difference (RD)|-0.015||||0.25|TWO_SIDED|95.0|-0.053|0.018||Two-sided test using the central method of doubling the one-sided p-value.|Barnard's Exact Unconditional Test|||The null hypothesis is that the risk difference, where the difference is represented as the Moderna COVID-19 vaccine first injection proportion minus comparison placebo first injection proportion, is not statistically different from 0 (i.e. there is no difference).||0.018|-0.053|0.250
72612425|NCT04761822|144753633|SUPERIORITY||Risk Difference (RD)|0.058||||0.004|TWO_SIDED|95.0|0.024|0.101||Two-sided test using the central method of doubling the one-sided p-value.|Barnard's Exact Unconditional Test|||The null hypothesis is that the risk difference, where the difference is represented as the high allergy/mast cell disorder cohort proportion minus comparison cohort proportion, is not statistically different from 0 (i.e. there is no difference).||0.101|0.024|0.004
72612426|NCT04761822|144753634|SUPERIORITY||Risk Difference (RD)|0.075|||<|0.001|TWO_SIDED|95.0|0.039|0.124||Two-sided test using the central method of doubling the one-sided p-value.|Barnard's Exact Unconditional Test|||The null hypothesis is that the risk difference, where the difference is represented as the high allergy/mast cell disorder cohort proportion minus comparison cohort proportion, is not statistically different from 0 (i.e. there is no difference).||0.124|0.039|<0.001
72612427|NCT04476043|144753635|SUPERIORITY||Least squares mean (LSM) difference|-2.7|STANDARD_ERROR_OF_MEAN|1.23||0.0277|TWO_SIDED|95.0|-5.2|-0.3|||MMRM|||||-0.3|-5.2|0.0277
72612428|NCT04476043|144753635|SUPERIORITY||LSM difference|-4.4|STANDARD_ERROR_OF_MEAN|1.25||0.0006|TWO_SIDED|95.0|-6.8|-1.9|||MMRM|||||-1.9|-6.8|0.0006
72612429|NCT04476043|144753635|SUPERIORITY||LSM difference|-3.8|STANDARD_ERROR_OF_MEAN|1.22||0.0021|TWO_SIDED|95.0|-6.2|-1.4|||MMRM|||||-1.4|-6.2|0.0021
72612430|NCT04476043|144753636|SUPERIORITY||Odds Ratio (OR)|2.3||||0.0445|TWO_SIDED|95.0|1.0|5.3|||Wald test||Logistic regression model with treatment group and stratification factors (disease severity and geographical region).|||5.3|1.0|0.0445
72612431|NCT04476043|144753636|SUPERIORITY||Difference in response rate|19.2|STANDARD_ERROR_OF_MEAN|9.35|||||||||||Standard error of difference between response rates was from normal approximation.|||||
72612432|NCT04476043|144753636|SUPERIORITY||Odds Ratio (OR)|2.0||||0.0998|TWO_SIDED|95.0|0.9|4.6|||Wald test||Logistic regression model with treatment group and stratification factors (disease severity and geographical region).|||4.6|0.9|0.0998
72612433|NCT04476043|144753636|SUPERIORITY||Difference in response rate|15.4|STANDARD_ERROR_OF_MEAN|9.32|||||||||||Standard error of difference between response rates was from normal approximation.|||||
72612434|NCT04476043|144753636|SUPERIORITY||Odds Ratio (OR)|2.1||||0.0829|TWO_SIDED|95.0|0.9|4.7|||Wald test||Logistic regression model with treatment group and stratification factors (disease severity and geographical region).|||4.7|0.9|0.0829
72612435|NCT04476043|144753636|SUPERIORITY||Difference in response rate|16.4|STANDARD_ERROR_OF_MEAN|9.29|||||||||||Standard error of difference between response rates was from normal approximation.|||||
72612436|NCT02385318|144753653|EQUIVALENCE|85% power of success|Equivalence ratio|1.11|||||TWO_SIDED|90.0|-4.38|14.44|||Yates correction|||||14.44|-4.38|
72612437|NCT01080261|144753654|NON_INFERIORITY_OR_EQUIVALENCE|Study had 91% statistical power to demonstrate that the 9-month rate for MACE (accounting for an expected 9-month attrition rate of 10%) is less than the performance goal, assuming a 9-month MACE rate of 8.2%.|Percent of patients experiencing a MACE|0.0|||<|0.0001|ONE_SIDED|95.0||4.9|||One-group exact binomial test|||A one-group exact binomial test was used to test the hypothesis that the percentage of patients experiencing a MACE event (primary endpoint) in the PROMUS Element cohort is less than the predefined performance goal of 24.1% (based on historical outcomes with plain balloon angioplasty \[20.2%\] plus an adjustment of 3.9% for small vessels).||4.9||<0.0001
72612438|NCT02594111|144753666|SUPERIORITY||||||<|0.05|||||||Chi-squared|||||||<0.05
72612439|NCT01126424|144753684|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-20.986||||0.3771|TWO_SIDED|95.0|-68.58|26.607|||ANCOVA|The analysis was performed using an ANCOVA model with fixed effect for treatment, period, subjects as a random effect and baseline as a covariate.||"Comparison of solifenacin versus placebo change from Baseline at 6 hours~The null hypothesis was that the mean change from baseline was the same in both treatments."||26.607|-68.580|0.3771
72612440|NCT01126424|144753684|SUPERIORITY_OR_OTHER||Least Square Mean Difference|17.508||||0.4487|TWO_SIDED|95.0|-28.854|63.87|||ANCOVA|The analysis was performed using an ANCOVA model with fixed effect for treatment, period, subjects as a random effect and baseline as a covariate.||"Comparison of oxybutynin versus placebo change from Baseline at 2 hours~The null hypothesis was that the mean change from baseline was the same in both treatments."||63.870|-28.854|0.4487
72612441|NCT01126424|144753685|SUPERIORITY_OR_OTHER||Least Square Mean Difference|9.152||||0.0505|TWO_SIDED|95.0|-0.023|18.326|||ANCOVA|The analysis was performed using an ANCOVA model with fixed effect for treatment, period, subjects as a random effect and baseline as a covariate.||"Comparison of solifenacin versus placebo change from Baseline at 6 hours~The null hypothesis was that the mean change from baseline was the same in both treatments."||18.326|-0.023|0.0505
72612442|NCT01126424|144753685|SUPERIORITY_OR_OTHER||Least Square Mean Difference|1.846||||0.6753|TWO_SIDED|95.0|-7.02|10.713|||ANCOVA|The analysis was performed using an ANCOVA model with fixed effect for treatment, period, subjects as a random effect and baseline as a covariate.||"Comparison of oxybutynin versus placebo change from Baseline at 2 hours~The null hypothesis was that the mean change from baseline was the same in both treatments."||10.713|-7.020|0.6753
72612443|NCT01126424|144753686|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-0.507||||0.5684|TWO_SIDED|95.0|-2.293|1.279|||ANCOVA|The analysis was performed using an ANCOVA model with fixed effect for treatment, period, subjects as a random effect and baseline as a covariate.||"Comparison of solifenacin versus placebo change from Baseline at 6 hours~The null hypothesis was that the mean change from baseline was the same in both treatments."||1.279|-2.293|0.5684
72612444|NCT01126424|144753686|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-0.792||||0.2348|TWO_SIDED|95.0|-2.122|0.538|||ANCOVA|The analysis was performed using an ANCOVA model with fixed effect for treatment, period, subjects as a random effect and baseline as a covariate.||"Comparison of oxybutynin versus placebo change from Baseline at 2 hours~The null hypothesis was that the mean change from baseline was the same in both treatments."||0.538|-2.122|0.2348
72326794|NCT03141255|144176883|SUPERIORITY|||||||0.516|||||||Fisher Exact|||||||0.516
72326795|NCT03141255|144176884|OTHER|||||||0.75|||||||Kaplan Meier|||||||0.75
72326796|NCT03141255|144176885|SUPERIORITY|||||||0.43|||||||t-test, 2 sided|||||||0.43
72612445|NCT01126424|144753687|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-0.04||||0.6275|TWO_SIDED|95.0|-0.208|0.127|||ANCOVA|The analysis was performed using an ANCOVA model with fixed effect for treatment, period, subjects as a random effect and baseline as a covariate.||"Comparison of solifenacin versus placebo change from Baseline at 6 hours~The null hypothesis was that the mean change from baseline was the same in both treatments."||0.127|-0.208|0.6275
72612446|NCT01126424|144753687|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-0.046||||0.5361|TWO_SIDED|95.0|-0.194|0.103|||ANCOVA|The analysis was performed using an ANCOVA model with fixed effect for treatment, period, subjects as a random effect and baseline as a covariate.||"Comparison of oxybutynin versus placebo change from Baseline at 2 hours~The null hypothesis was that the mean change from baseline was the same in both treatments."||0.103|-0.194|0.5361
72612447|NCT01126424|144753688|SUPERIORITY_OR_OTHER||Least Square Mean Difference|4.655||||0.6315|TWO_SIDED|95.0|-14.858|24.167|||ANCOVA|The analysis was performed using an ANCOVA model with fixed effect for treatment, period, subjects as a random effect and baseline as a covariate.||"Comparison of solifenacin versus placebo change from Baseline at 6 hours~The null hypothesis was that the mean change from baseline was the same in both treatments."||24.167|-14.858|0.6315
72612448|NCT01126424|144753688|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-1.457||||0.867|TWO_SIDED|95.0|-18.976|16.062|||ANCOVA|The analysis was performed using an ANCOVA model with fixed effect for treatment, period, subjects as a random effect and baseline as a covariate.||"Comparison of oxybutynin versus placebo change from Baseline at 2 hours~The null hypothesis was that the mean change from baseline was the same in both treatments."||16.062|-18.976|0.8670
72612449|NCT01126424|144753689|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-77.919||||0.5953|TWO_SIDED|95.0|-372.814|216.976|||ANCOVA|The analysis was performed using an ANCOVA model with fixed effect for treatment, period, subjects as a random effect and baseline as a covariate.||"Comparison of solifenacin versus placebo change from Baseline at 6 hours~The null hypothesis was that the mean change from baseline was the same in both treatments."||216.976|-372.814|0.5953
72612450|NCT01126424|144753689|SUPERIORITY_OR_OTHER||Least Square Mean Difference|157.783||||0.3526|TWO_SIDED|95.0|-182.015|497.581|||ANCOVA|The analysis was performed using an ANCOVA model with fixed effect for treatment, period, subjects as a random effect and baseline as a covariate.||"Comparison of oxybutynin versus placebo change from Baseline at 2 hours~The null hypothesis was that the mean change from baseline was the same in both treatments."||497.581|-182.015|0.3526
72612451|NCT00248560|144753690|SUPERIORITY_OR_OTHER||Response rate|0.17|||||TWO_SIDED|95.0|0.08|0.32||||||||0.32|0.08|
72612452|NCT01134042|144753702|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.193|||<|0.001|TWO_SIDED|95.0|0.108|0.277|||ANCOVA|||||0.277|0.108|<0.001
72612453|NCT01134042|144753702|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.21|||<|0.001|TWO_SIDED|95.0|0.127|0.294|||ANCOVA|||||0.294|0.127|<0.001
72612454|NCT01134042|144753702|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the confidence interval (CI: 0.025, 1-sided significance level) for the mean difference in change from Baseline in clinic visit trough FEV1 of FF 200 µg OD versus FP 500 µg BID was greater than -125 milliliters.|Median Difference (Final Values)|0.018|||||TWO_SIDED|95.0|-0.066|0.102||||||||0.102|-0.066|
72612455|NCT01134042|144753703|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.136||||0.048|TWO_SIDED|95.0|0.001|0.27|||ANCOVA|||||0.270|0.001|0.048
72612456|NCT01134042|144753703|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.206||||0.003|TWO_SIDED|95.0|0.073|0.339|||ANCOVA|||||0.339|0.073|0.003
72612457|NCT00393367|144753713|SUPERIORITY_OR_OTHER|||||||0.44||95.0||||The difference in median improvement between treatment groups was expected to be greater than 2.|Wilcoxon (Mann-Whitney)|||||||0.44
72612458|NCT00393367|144753714|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.0||||0.97|TWO_SIDED|95.0|-0.14|0.14|||Chi-squared|||||0.14|-0.14|0.97
72612459|NCT00393367|144753715|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.0|STANDARD_ERROR_OF_MEAN|3.0|||TWO_SIDED|95.0|-7.0|6.0|||t-test, 2 sided|||||6|-7|
72612460|NCT00393367|144753716|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|1.6|||TWO_SIDED|95.0|-3.0|3.0|||t-test, 2 sided|||||3|-3|
72612461|NCT00393367|144753717|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|0.49|||TWO_SIDED|95.0|-1.0|1.0|||t-test, 2 sided|||||1|-1|
72612462|NCT00393367|144753718|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.03||||0.69||95.0|-0.2|0.14|||Chi-squared|||||0.14|-0.20|0.69
72612463|NCT00393367|144753719|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.22||||0.08|TWO_SIDED|95.0|-0.02|0.47|||Chi-squared|||||0.47|-0.02|0.08
72612464|NCT00393367|144753720|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.14||||0.22|TWO_SIDED|95.0|-0.37|0.08|||Chi-squared|||||0.08|-0.37|0.22
72612465|NCT00393367|144753722|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.1|STANDARD_ERROR_OF_MEAN|0.36||0.78|TWO_SIDED|95.0|-0.6|0.8|||t-test, 2 sided|||||0.8|-0.6|0.78
72612466|NCT03286504|144753725|SUPERIORITY||proportion difference|0.05||||0.55|TWO_SIDED|95.0|-0.112|0.212|||Chi-squared||Direction of proportion difference = FANMI arm minus Standard of Care arm|||0.212|-0.112|0.55
72612467|NCT03286504|144753726|SUPERIORITY||proportion difference|0.033||||0.71|TWO_SIDED|95.0|-0.145|0.211|||Chi-squared||Direction of proportion difference = FANMI arm minus Standard of Care arm|||0.211|-0.145|0.71
72612468|NCT03286504|144753728|SUPERIORITY||proportion difference|-0.05||||0.65|TWO_SIDED|95.0|-0.269|0.169|||Chi-squared||Direction of proportion difference = FANMI arm minus Standard of Care arm|||0.169|-0.269|0.65
72326797|NCT03141255|144176886|SUPERIORITY|||||||0.052|||||||t-test, 2 sided|||||||0.052
72326798|NCT04419467|144176906|SUPERIORITY||GM % treatment difference (80% CI)|-0.5||||0.485|TWO_SIDED|80.0|-14.8|16.3||One-sided p-value|Mixed Models Repeated Measures Analysis||Data analyzed are log-transformed values of ACR, using MMRM. Comparisons vs. placebo are back-transformed by exponentiation to obtain geometric mean (GM), then expressed as percent treatment difference.|||16.3|-14.8|0.485
72326799|NCT04419467|144176906|SUPERIORITY||GM % treatment difference (80% CI)|8.6||||0.75|TWO_SIDED|80.0|-7.2|27.2||One-sided p-value|Mixed Models Repeated Measures Analysis||Data analyzed are log-transformed values of ACR, using MMRM. Comparisons vs. placebo are back-transformed by exponentiation to obtain geometric mean, then expressed as percent treatment difference|||27.2|-7.2|0.750
72326800|NCT01925768|144176923|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|17.7||||0.004|TWO_SIDED|95.0|6.2|29.3||Two-sided p-value is based on the Cochran-Mantel-Haenszel test adjusting for previous DMARD use and baseline Oral Corticosteroids (Prednisone or equivalent) use.|Cochran-Mantel-Haenszel||Adjusted difference in proportions is the weighted average of the treatment differences across 4 strata by the 2 stratification factors: previous DMARD use and baseline Corticosteroids use using CMH weights. The CI is based on a normal approximation.|||29.3|6.2|0.0040
72326801|NCT01925768|144176924|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.103||||0.1677|TWO_SIDED|95.0|-0.251|0.044|||Mixed Models Analysis|Those with a baseline and at least 1 postbaseline value at the PBO controlled phase were counted with mixed effects model for repeated measure (MMRM)|The LS mean (SE) and 2-sided p-value were based on a MMRM analysis for change from baseline, with treatment group, time, treatment-by-time interaction, and previous DMARD and baseline corticosteroids used as factors and baseline value as a covariate|||0.044|-0.251|0.1677
72326802|NCT01925768|144176925|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|18.5||||0.004|TWO_SIDED|95.0|6.3|30.6||Two-sided p-value is based on the Cochran-Mantel-Haenszel test adjusting for previous DMARD use and baseline Oral Corticosteroids (Prednisone or equivalent) use.|Cochran-Mantel-Haenszel|Those who withdrew early or who did not have sufficient data at Week 16 were counted as non-responders.|Adjusted difference in proportions is the weighted average of the treatment differences across 4 strata by the 2 stratification factors: previous DMARD use and baseline Corticosteroids use using CMH weights. The CI is based on a normal approximation.|||30.6|6.3|0.0040
72326803|NCT01925768|144176926|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.5||||0.0051|TWO_SIDED|95.0|-0.85|-0.15|||Mixed Models Analysis||The LS mean (SE) and 2-sided p-value were based on a MMRM analysis for change from baseline, with treatment group, time, treatment-by-time interaction, and previous DMARD and baseline corticosteroids used as factors and baseline value as a covariate.|||-0.15|-0.85|0.0051
72612469|NCT03286504|144753729|SUPERIORITY||proportion difference|0.226||||0.04|TWO_SIDED|95.0|0.015|0.438|||Chi-squared||Direction of proportion difference = FANMI arm minus Standard of Care arm|||0.438|0.015|0.04
72326804|NCT01925768|144176927|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|2.68||||0.0167|TWO_SIDED|95.0|0.49|4.88|||Mixed Models Analysis|Those with a baseline and at least 1 postbaseline value at the PBO controlled phase were counted with mixed effects model for repeated measure (MMRM)|The LS mean (SE) and 2-sided p-value were based on a MMRM analysis for change from baseline, with treatment group, time, treatment-by-time interaction, and previous DMARD and baseline corticosteroids used as factors and baseline value as a covariate|||4.88|0.49|0.0167
72326805|NCT01925768|144176928|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|3.4||||0.0039|TWO_SIDED|95.0|1.1|5.7||Based on an MMRM model for the change from baseline, with treatment group, time, treatment-by-time interaction, and previous DMARD use and baseline Oral Corticosteroids use as factors and the baseline value as a covariate.|Mixed Models Analysis|||2-sided 95% CI for the difference in LS mean.||5.70|1.10|0.0039
72326806|NCT01925768|144176929|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-10.0||||0.012|TWO_SIDED|95.0|-21.5|10.2|||Sign test|p-value based on distribution free signed rank test||||10.2|-21.5|0.012
72326807|NCT01925768|144176930|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|19.7||||0.0016|TWO_SIDED|95.0|8.0|31.3||Two-sided p-value is based on the Cochran-Mantel-Haenszel test adjusting for previous DMARD use and baseline oral corticosteroids (prednisone or equivalent) use.|Cochran-Mantel-Haenszel||Adjusted difference in proportions is the weighted average of the treatment differences across 4 strata by the 2 stratification factors: previous DMARD use and baseline Corticosteroids use using CMH weights. The CI is based on a normal approximation.|||31.3|8.0|0.0016
72326808|NCT01925768|144176931|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.15||||0.0229|TWO_SIDED|95.0|-0.279|-0.021|||Mixed Models Analysis||The LS mean (SE) and 2-sided p-value were based on a MMRM analysis for change from baseline, with treatment group, time, treatment-by-time interaction, and previous DMARD and baseline corticosteroids used as factors and baseline value as a covariate|||-0.021|-0.279|0.0229
72612470|NCT03286504|144753730|SUPERIORITY||proportion difference|0.208||||0.03|TWO_SIDED|95.0|0.023|0.393|||Chi-squared||Direction of proportion difference = FANMI arm minus Standard of Care arm.|||0.393|0.023|0.03
72612471|NCT02030600|144753740|SUPERIORITY_OR_OTHER||Treatment ratio|0.7|||<|0.0001|TWO_SIDED|95.0|0.61|0.8|||Poisson||Superiority was considered confirmed if the 95% confidence interval for the rate ratio (IDeg/IGlar) was entirely below 1.0.|"Stepwise hierarchical testing procedure was applied for confirmatory endpoints:~Step 1: Primary analysis: Number of treatment emergent severe or BG confirmed symptomatic hypoglycaemic episodes during the maintenance period"||0.80|0.61|<0.0001
72612472|NCT02030600|144753741|SUPERIORITY_OR_OTHER||Treatment ratio|0.58|||<|0.0001|TWO_SIDED|95.0|0.46|0.74|||Poisson||Superiority was considered confirmed if the 95% confidence interval for the rate ratio (IDeg/IGlar) was entirely below 1.0.|"Stepwise hierarchical testing procedure was applied for confirmatory endpoints:~Step 2: Number of treatment-emergent severe or BG confirmed symptomatic nocturnal hypoglycaemic episodes during the maintenance period."||0.74|0.46|<0.0001
72612473|NCT02030600|144753742|SUPERIORITY_OR_OTHER|||||||0.3458||||||Superiority was confirmed if the p-value was less than 0.025.|McNemar|||"Stepwise hierarchical testing procedure:~Step 3: Proportion of subjects with one or more severe hypoglycaemic episodes in the maintenance period."||||0.3458
72612474|NCT02030600|144753744|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority of IDeg against IGlar was considered confirmed if the upper bound of the two-sided 95% confidence interval was below or equal to 0.40%.|Treatment contrast|0.09|||||TWO_SIDED|95.0|-0.04|0.23||||||"Change from baseline in HbA1c at week 32 (treatment period 1). Before the primary endpoint was tested, the secondary supportive efficacy endpoint Change from baseline in HbA1c after 32 weeks of treatment was tested for non-inferiority as prerequisite for testing the primary endpoint. Analysis was performed using a mixed model for repeated measurement (MMRM) with treatment, sex, antidiabetic therapy at screening, visit and dosing time as fixed effects, and age and baseline HbA1c as covariates."||0.23|-0.04|
72612475|NCT02030600|144753744|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was considered confirmed if the upper bound of the two-sided 95% confidence interval was below or equal to 0.40%|Treatment contrast|0.06|||||TWO_SIDED|95.0|-0.07|0.18||||||"Change from baseline in HbA1c at week 64 (treatment period 2). The baseline values are week 32 values. Before the primary endpoint was tested, the secondary supportive efficacy endpoint Change from baseline in HbA1c after 32 weeks of treatment was tested for non-inferiority as prerequisite for testing the primary endpoint. Analysis was performed using a MMRM with treatment, sex, antidiabetic therapy at screening, visit and dosing time as fixed effects, and age and baseline HbA1c as covariates."||0.18|-0.07|
72612476|NCT01155323|144753746|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.11|||TWO_SIDED|95.0|-0.21|0.23|||Mixed Models Analysis||Mean difference is calculated as etafilcon A minus omafilcon A.|The alternative hypothesis was that etafilcon A would be superior to omafilcon A for comfort.||0.23|-0.21|
72326809|NCT01925768|144176932|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.68|||<|0.0001|TWO_SIDED|95.0|-1.0|-0.35|||Mixed Models Analysis||The LS mean (SE) and 2-sided p-value were based on a MMRM analysis for change from baseline, with treatment group, time, treatment-by-time interaction, and previous DMARD and baseline corticosteroids used as factors and baseline value as a covariate|||-0.35|-1.00|<0.0001
72326810|NCT01925768|144176933|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|3.46||||0.0039|TWO_SIDED|95.0|1.13|5.8|||Mixed Models Analysis||Adjusted difference in proportions is the weighted average of the treatment differences across 4 strata by the 2 stratification factors: previous DMARD use and baseline Corticosteroids use using CMH weights|||5.80|1.13|0.0039
72326811|NCT01925768|144176934|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehmann|10.0||||0.0168|TWO_SIDED|95.0|0.0|20.0|||Stratified Van Elteren test|p-value based on stratified Van Elteren test, using 2 stratification factors: previous DMARD use and baseline Oral Corticosteroids|Location shift and 95% CI based on Hodges-Lehmann for between treatment median estimates.|||20.0|0.0|0.0168
72326812|NCT01925768|144176935|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|20.7||||0.0015|TWO_SIDED|95.0|8.5|32.8||2 sided-p-value is based on the Cochran-Mantel-Haenszel test adjusting for previous DMARD use and baseline Oral Corticosteroids (Prednisone or equivalent) use.|Cochran-Mantel-Haenszel||Adjusted difference in proportions is the weighted average of the treatment differences across 4 strata by the 2 stratification factors: previous DMARD use and baseline Corticosteroids use using CMH weights|||32.8|8.5|0.0015
72326813|NCT01925768|144176936|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|9.7||||0.0252|TWO_SIDED|95.0|1.6|17.7||Two-sided p-value is based on the Cochran-Mantel-Haenszel test adjusting for previous DMARD use and baseline Oral Corticosteroids (Prednisone or equivalent) use.|Cochran-Mantel-Haenszel||Adjusted difference in proportions is the weighted average of the treatment differences across 4 strata by 2 stratification factors: previous DMARD use and baseline Corticosteroids use using CMH weights|Week 2; 2-sided 95% CI is based on a normal approximation to the weighted average||17.7|1.6|0.0252
72612477|NCT01155323|144753747|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin = -0.50|Mean Difference (Final Values)|0.03|STANDARD_ERROR_OF_MEAN|0.11|||TWO_SIDED|95.0|-0.19|0.25|||Mixed Models Analysis||The mean difference is calculated as etafilcon A minus omafilcon A.|The alternative hypothesis was that etafilcon A would be non-inferior to omafilcon A for vision.||0.25|-0.19|
72612478|NCT01155323|144753748|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin = -0.50|Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.11|||TWO_SIDED|95.0|-0.22|0.22|||||The mean difference is calculated as etafilcon A minus omafilcon A.|The alternative hypothesis was that etafilcon A would be non-inferior to omafilcon A for lens handling.||0.22|-0.22|
72612479|NCT01155323|144753749|NON_INFERIORITY_OR_EQUIVALENCE|Margin = +/-0.50|Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.01|||TWO_SIDED|95.0|-0.03|0.01|||Mixed Models Analysis||The mean difference is calculated as etafilcon A minus omafilcon A.|The alternative hypothesis was that etafilcon A would be equivalent to omafilcon A for corneal staining.||0.01|-0.03|
72612480|NCT01155323|144753750|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin = -0.50|Mean Difference (Final Values)|0.07|STANDARD_ERROR_OF_MEAN|0.11|||TWO_SIDED|95.0|-0.15|0.29|||Mixed Models Analysis||The mean difference is calculated as etafilcon A minus omafilcon A.|The alternative hypothesis was that etafilcon A would be non-inferior to omafilcon A for quality perceptions.||0.29|-0.15|
72612481|NCT01155323|144753751|NON_INFERIORITY_OR_EQUIVALENCE|Margin = +/- 0.50|Mean Difference (Final Values)|0.03|STANDARD_ERROR_OF_MEAN|0.02|||TWO_SIDED|95.0|-0.01|0.06|||Mixed Models Analysis||The mean difference is calculated as etafilcon A minus omafilcon A.|The alternative hypothesis was that etafilcon A would be equivalent to omafilcon A from limbal hyperemia.||0.06|-0.01|
72612482|NCT04154956|144753767|SUPERIORITY||Hazard Ratio (HR)|1.143||||0.8204|TWO_SIDED|95.0|0.864|1.512||One-sided significance level was 0.01|Log Rank||Hazard ratio and confidence intervals (CIs) were computed from a stratified Cox model according to stratification factors as per IRT.|||1.512|0.864|0.8204
72612483|NCT04154956|144753768|SUPERIORITY||Hazard Ratio (HR)|0.846||||0.112|TWO_SIDED|95.0|0.644|1.109||One-sided significance level was 0.00174.|Log Rank||Hazard ratio and CIs were computed from a stratified Cox model according to stratification factors as per IRT.|||1.109|0.644|0.1120
72612484|NCT04154956|144753769|SUPERIORITY||Odds Ratio (OR)|0.88||||0.6972|TWO_SIDED|95.0|0.55|1.42||P-value is provided for information only, there is no statistical inference based on this P-value.|Cochran-Mantel-Haenszel||Odds ratio and its 2-sided CI were provided from a Cochran-Mantel-Haenszel (CMH) test stratified according to the stratification factors.|||1.42|0.55|0.6972
72612485|NCT04154956|144753770|SUPERIORITY||Hazard Ratio (HR)|0.729||||0.0157|TWO_SIDED|95.0|0.546|0.972||P-value is provided for information only, there is no statistical inference based on this P-value.|Log Rank||Hazard ratio and CIs were computed from a stratified Cox model according to stratification factors as per IRT.|||0.972|0.546|0.0157
72612486|NCT04154956|144753771|SUPERIORITY||Hazard Ratio (HR)|0.544||||0.0002|TWO_SIDED|95.0|0.388|0.763||P-value is provided for information only, there is no statistical inference based on this P-value.|Log Rank||Hazard ratio and CIs were computed from a stratified Cox model according to stratification factors as per IRT.|||0.763|0.388|0.0002
72612487|NCT04154956|144753772|SUPERIORITY||Hazard Ratio (HR)|0.735||||0.0305|TWO_SIDED|95.0|0.533|1.014||P-value is provided for information only, there is no statistical inference based on this P-value.|Log Rank||Hazard ratio and CIs were computed from a stratified Cox model according to stratification factors as per IRT.|||1.014|0.533|0.0305
72612488|NCT00460798|144753794|SUPERIORITY_OR_OTHER||Obective Response Rate (Percent)|40.6|||||TWO_SIDED|95.0|35.5|46.0|||||Exact method based on binomial distribution|Objective Response Rate (ORR) = Percentage of participants with best overall response of CR or PR||46.0|35.5|
72612489|NCT02320396|144753834|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares (LS) Means|-0.83|||<|0.001|TWO_SIDED|95.0|-1.14|-0.51|||cLDA model|||The LS mean change from BL to post BL (average score of 2 weeks) in TNSS was estimated using a constrained longitudinal data analysis (cLDA) model, where both BL and post-BL measurements (average score of 2 weeks) were included in the response variable. The treatment difference in terms of LS mean change from BL between desloratadine 5 mg and placebo was evaluated with the 95% confidence interval and P-value.||-0.51|-1.14|<0.001
72612490|NCT02320396|144753837|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.82|||<|0.001|TWO_SIDED|95.0|-1.14|-0.5|||cLDA model|||"Change from BL in TNSS at Week 1: Desloratadine vs. Placebo~The LS mean change from BL to Week 1 post BL in TNSS was estimated using a cLDA model, where both BL and post-BL measurements (average score of 1 week prior to Week 1) were included in the response variable. The treatment difference in terms of LS mean change from BL between desloratadine 5 mg and placebo was evaluated with the 95% confidence interval and P-value."||-0.50|-1.14|<0.001
72612491|NCT02320396|144753837|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.84|||<|0.001|TWO_SIDED|95.0|-1.23|-0.46|||cLDA model|||"Change from BL in TNSS at Week 2: Desloratadine vs. Placebo~The LS mean change from BL to Week 2 post BL in TNSS was estimated using a cLDA model, where both BL and post- BL measurements (average score of 1 week prior to Week 2) were included in the response variable. The treatment difference in terms of LS mean change from BL between desloratadine 5 mg and placebo was evaluated with the 95% confidence interval and P-value."||-0.46|-1.23|<0.001
72612492|NCT02320396|144753838|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.25|||<|0.001|TWO_SIDED|95.0|-0.35|-0.14|||cLDA model|||"Change from BL to Week 1 in Sneezing: Desloratadine vs. Placebo~The LS mean change from BL to Week 1 post BL in Sneezing was estimated using a cLDA model, where both BL and post-BL measurements (average score of 1 week prior to Week 1) were included in the response variable. The treatment difference in terms of LS mean change from BL between desloratadine 5 mg and placebo was evaluated with the 95% confidence interval and P-value."||-0.14|-0.35|<0.001
72612493|NCT02320396|144753838|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.21|||<|0.001|TWO_SIDED|95.0|-0.32|-0.1|||cLDA model|||"Change from BL to Week 1 in Rhinorrhea: Desloratadine vs. Placebo~The LS mean change from BL to Week 1 post BL in Rhinorrhea was estimated using a cLDA model, where both BL and post-BL measurements (average score of 1 week prior to Week 1) were included in the response variable. The treatment difference in terms of LS mean change from BL between desloratadine 5 mg and placebo was evaluated with the 95% confidence interval and P-value."||-0.10|-0.32|<0.001
72612494|NCT02320396|144753838|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.09||||0.008|TWO_SIDED|95.0|-0.16|-0.02|||cLDA model|||"Change from BL to Week 1 in Nasal Congestion: Desloratadine vs. Placebo~The LS mean change from BL to Week 1 post BL in Nasal Congestion was estimated using a cLDA model, where both BL and post-BL measurements (average score of 1 week prior to Week 1) were included in the response variable. The treatment difference in terms of LS mean change from BL between desloratadine 5 mg and placebo was evaluated with the 95% confidence interval and P-value."||-0.02|-0.16|0.008
72612495|NCT02320396|144753838|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.27|||<|0.001|TWO_SIDED|95.0|-0.38|-0.15|||cLDA model|||"Change from BL to Week 1 in Nasal Itching: Desloratadine vs. Placebo~The LS mean change from BL to Week 1 post BL in Nasal Itching was estimated using a cLDA model, where both BL and post-BL measurements (average score of 1 week prior to Week 1) were included in the response variable. The treatment difference in terms of LS mean change from BL between desloratadine 5 mg and placebo was evaluated with the 95% confidence interval and P-value."||-0.15|-0.38|<0.001
72612496|NCT02320396|144753839|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.25|||<|0.001|TWO_SIDED|95.0|-0.36|-0.13|||cLDA model|||"Change from BL to Week 2 in Sneezing: Desloratadine vs. Placebo~The LS mean change from BL to Week 2 post BL in Sneezing was estimated using a cLDA model, where both BL and post-BL measurements (average score of 1 week prior to Week 2) were included in the response variable. The treatment difference in terms of LS mean change from BL between desloratadine 5 mg and placebo was evaluated with the 95% confidence interval and P-value."||-0.13|-0.36|<0.001
72612497|NCT02320396|144753839|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.25|||<|0.001|TWO_SIDED|95.0|-0.37|-0.12|||cLDA model|||"Change from BL to Week 2 in Rhinorrhea: Desloratadine vs. Placebo~The LS mean change from BL to Week 2 post BL in Rhinorrhea was estimated using a cLDA model, where both BL and post-BL measurements (average score of 1 week prior to Week 2) were included in the response variable. The treatment difference in terms of LS mean change from BL between desloratadine 5 mg and placebo was evaluated with the 95% confidence interval and P-value."||-0.12|-0.37|<0.001
72612498|NCT02320396|144753839|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.09||||0.037|TWO_SIDED|95.0|-0.18|-0.01|||cLDA model|||"Change from BL to Week 2 in Nasal Congestion: Desloratadine vs. Placebo~The LS mean change from BL to Week 2 post BL in Nasal Congestion was estimated using a cLDA model, where both BL and post-BL measurements (average score of 1 week prior to Week 2) were included in the response variable. The treatment difference in terms of LS mean change from BL between desloratadine 5 mg and placebo was evaluated with the 95% confidence interval and P-value."||-0.01|-0.18|0.037
72612499|NCT02320396|144753839|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.26|||<|0.001|TWO_SIDED|95.0|-0.4|-0.12|||cLDA model|||"Change from BL to Week 2 in Nasal Itching: Desloratadine vs. Placebo~The LS mean change from BL to Week 2 post BL in Nasal Itching was estimated using a cLDA model, where both BL and post-BL measurements (average score of 1 week prior to Week 2) were included in the response variable. The treatment difference in terms of LS mean change from BL between desloratadine 5 mg and placebo was evaluated with the 95% confidence interval and P-value."||-0.12|-0.40|<0.001
72612500|NCT02320396|144753840|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.25|||<|0.001|TWO_SIDED|95.0|-0.35|-0.14|||cLDA model|||"Change from BL in Sneezing During 2 Weeks: Desloratadine vs. Placebo~The LS mean change from BL to post BL (average score of 2 weeks) in Sneezing was estimated using a cLDA model, where both BL and post-BL measurements (average score from Day 1 to Day 13) were included in the response variable. The treatment difference in terms of LS mean change from BL between desloratadine 5 mg and placebo was evaluated with the 95% confidence interval and P-value."||-0.14|-0.35|<0.001
72612501|NCT02320396|144753840|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.23|||<|0.001|TWO_SIDED|95.0|-0.33|-0.12|||cLDA model|||"Change from BL in Rhinorrhea During 2 Weeks: Desloratadine vs. Placebo~The LS mean change from BL to post BL (average score of 2 weeks) in Rhinorrhea was estimated using a cLDA model, where both BL and post-BL measurements (average score from Day 1 to Day 13) were included in the response variable. The treatment difference in terms of LS mean change from BL between desloratadine 5 mg and placebo was evaluated with the 95% confidence interval and P-value."||-0.12|-0.33|<0.001
72326814|NCT01925768|144176936|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|8.6||||0.1121|TWO_SIDED|95.0|-1.7|18.9||Two-sided p-value is based on the Cochran-Mantel-Haenszel test adjusting for previous DMARD use and baseline Oral Corticosteroids (Prednisone or equivalent) use.|Cochran-Mantel-Haenszel||Adjusted difference in proportions is the weighted average of the treatment differences across 4 strata by 2 stratification factors: previous DMARD use and baseline Corticosteroids use using CMH weights|Week 4; 2-sided 95% CI is based on a normal approximation to the weighted average||18.9|-1.7|0.1121
72326815|NCT01925768|144176936|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|17.8||||0.0036|TWO_SIDED|95.0|6.2|29.3||Two-sided p-value is based on the Cochran-Mantel-Haenszel test adjusting for previous DMARD use and baseline Oral Corticosteroids (Prednisone or equivalent) use.|Cochran-Mantel-Haenszel||Adjusted difference in proportions is the weighted average of the treatment differences across 4 strata by 2 stratification factors: previous DMARD use and baseline Corticosteroids use using CMH weights|Week 6; 2-sided 95% CI is based on a normal approximation to the weighted average||29.3|6.2|0.0036
72612502|NCT02320396|144753840|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.09||||0.009|TWO_SIDED|95.0|-0.16|-0.02|||cLDA model|||"Change from BL in Nasal Congestion During 2 Weeks: Desloratadine vs. Placebo~The LS mean change from BL to post BL (average score of 2 weeks) in Nasal Congestion was estimated using a cLDA model, where both BL and post-BL measurements (average score from Day 1 to Day 13) were included in the response variable. The treatment difference in terms of LS mean change from BL between desloratadine 5 mg and placebo was evaluated with the 95% confidence interval and P-value."||-0.02|-0.16|0.009
72612503|NCT02320396|144753840|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.26|||<|0.001|TWO_SIDED|95.0|-0.38|-0.15|||cLDA model|||"Change from BL in Nasal Itching During 2 Weeks: Desloratadine vs. Placebo~The LS mean change from BL to post BL (average score of 2 weeks) in Nasal Itching was estimated using a cLDA model, where both BL and post-BL measurements (average score from Day 1 to Day 13) were included in the response variable. The treatment difference in terms of LS mean change from BL between desloratadine 5 mg and placebo was evaluated with the 95% confidence interval and P-value.~cLDA model"||-0.15|-0.38|<0.001
72612504|NCT02320396|144753841|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.25|||<|0.001|TWO_SIDED|95.0|-0.35|-0.15|||cLDA model|||"Change from BL to Week 1 in Eye Pruritus: Desloratadine vs. Placebo~The LS mean change from BL to Week 1 post BL in Eye Pruritus was estimated using a cLDA model, where both BL and post-BL measurements (average score of 1 week prior to Week 1) were included in the response variable. The treatment difference in terms of LS mean change from BL between desloratadine 5 mg and placebo was evaluated with the 95% confidence interval and P-value."||-0.15|-0.35|<0.001
72612505|NCT02320396|144753841|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.16|||<|0.001|TWO_SIDED|95.0|-0.24|-0.08|||cLDA model|||"Change from BL to Week 1 in Watering Eyes: Desloratadine vs. Placebo~The LS mean change from BL to Week 1 post BL in Watering Eyes was estimated using a cLDA model, where both BL and post-BL measurements (average score of 1 week prior to Week 1) were included in the response variable. The treatment difference in terms of LS mean change from BL between desloratadine 5 mg and placebo was evaluated with the 95% confidence interval and P-value."||-0.08|-0.24|<0.001
72612506|NCT02320396|144753841|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.25|||<|0.001|TWO_SIDED|95.0|-0.35|-0.15|||cLDA model|||"Change from BL to Week 1 in Worse of Pruritus or Watering Eyes: Desloratadine vs. Placebo~The LS mean change from BL to Week 1 post BL in the worse symptom of Pruritus or Watering Eyes estimated using a cLDA model, where both BL and post-BL measurements (average score of 1 week prior to Week 1) were included in the response variable. The treatment difference in terms of LS mean change from BL between desloratadine 5 mg and placebo was evaluated with the 95% confidence interval and P-value."||-0.15|-0.35|<0.001
72612507|NCT02320396|144753842|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.25|||<|0.001|TWO_SIDED|95.0|-0.37|-0.12|||cLDA model|||"Change from BL to Week 2 in Eye Pruritus: Desloratadine vs. Placebo~The LS mean change from BL to Week 2 post BL in Eye Pruritus was estimated using a cLDA model, where both BL and post-BL measurements (average score of 1 week prior to Week 2) were included in the response variable. The treatment difference in terms of LS mean change from BL between desloratadine 5 mg and placebo was evaluated with the 95% confidence interval and P-value."||-0.12|-0.37|<0.001
72612508|NCT02320396|144753842|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.13||||0.01|TWO_SIDED|95.0|-0.24|-0.03|||cLDA model|||"Change from BL to Week 2 in Watering Eyes: Desloratadine vs. Placebo~The LS mean change from BL to Week 2 post BL in Watering Eyes was estimated using a cLDA model, where both BL and post-BL measurements (average score of 1 week prior to Week 2) were included in the response variable. The treatment difference in terms of LS mean change from BL between desloratadine 5 mg and placebo was evaluated with the 95% confidence interval and P-value."||-0.03|-0.24|0.010
72612509|NCT02320396|144753842|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.24|||<|0.001|TWO_SIDED|95.0|-0.37|-0.12|||cLDA model|||"Change from BL to Week 2 in Worse of Pruritus or Watering Eyes: Desloratadine vs. Placebo~The LS mean change from BL to Week 2 post BL in the worse symptom of Pruritus or Watering Eyes estimated using a cLDA model, where both BL and post-BL measurements (average score of 1 week prior to Week 2) were included in the response variable. The treatment difference in terms of LS mean change from BL between desloratadine 5 mg and placebo was evaluated with the 95% confidence interval and P-value."||-0.12|-0.37|<0.001
72612510|NCT02320396|144753843|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.25|||<|0.001|TWO_SIDED|95.0|-0.35|-0.14|||cLDA model|||"Change from BL in Eye Pruritus During 2 Weeks: Desloratadine vs. Placebo~The LS mean change from BL to post BL (average score of 2 weeks) in Eye Pruritus was estimated using a cLDA model, where both BL and post-BL measurements (average score from Day 1 to Day 13) were included in the response variable. The treatment difference in terms of LS mean change from BL between desloratadine 5 mg and placebo was evaluated with the 95% confidence interval and P-value."||-0.14|-0.35|<0.001
72612511|NCT02320396|144753843|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.15|||<|0.001|TWO_SIDED|95.0|-0.23|-0.07|||cLDA model|||"Change from BL in Watering Eyes During 2 Weeks: Desloratadine vs. Placebo~The LS mean change from BL to post BL (average score of 2 weeks) in Watering Eyes was estimated using a cLDA model, where both BL and post-BL measurements (average score from Day 1 to Day 13) were included in the response variable. The treatment difference in terms of LS mean change from BL between desloratadine 5 mg and placebo was evaluated with the 95% confidence interval and P-value."||-0.07|-0.23|<0.001
72612512|NCT02320396|144753843|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.25|||<|0.001|TWO_SIDED|95.0|-0.35|-0.15|||cLDA model|||The LS mean change from BL to post BL (average score of 2 weeks) in the worse of Pruritus or Watering Eyes was estimated using a cLDA model, where both BL and post-BL measurements (average score from Day 1-Day 13) were included in the response variable. The treatment difference in terms of LS mean change from BL between desloratadine 5 mg and placebo was evaluated with the 95% confidence interval and P-value||-0.15|-0.35|<0.001
72612513|NCT02320396|144753844|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.16|||<|0.001|TWO_SIDED|95.0|-0.24|-0.07|||cLDA model|||"Change from BL to Week 1 in Interference with Daily Activities: Desloratadine vs. Placebo~The LS mean change from BL to Week 1 post BL in Interference with Daily Activities was estimated using a cLDA model, where both BL and post-BL measurements (average score of 1 week prior to Week 1) were included in the response variable. The treatment difference in terms of LS mean change from BL between desloratadine 5 mg and placebo was evaluated with the 95% confidence interval and P-value."||-0.07|-0.24|<0.001
72612514|NCT02320396|144753844|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.19|||<|0.001|TWO_SIDED|95.0|-0.3|-0.09|||cLDA model|||"Change from BL to Week 2 in Interference with Daily Activities: Desloratadine vs. Placebo~The LS mean change from BL to Week 2 post BL in Interference with Daily Activities was estimated using a cLDA model, where both BL and post-BL measurements (average score of 1 week prior to Week 2) were included in the response variable. The treatment difference in terms of LS mean change from BL between desloratadine 5 mg and placebo was evaluated with the 95% confidence interval and P-value."||-0.09|-0.30|<0.001
72612515|NCT02320396|144753844|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.17|||<|0.001|TWO_SIDED|95.0|-0.26|-0.08|||cLDA model|||"Change from BL in Interference with Daily Activities During 2 Wks: Desloratadine vs. Placebo~The LS mean change from BL to post BL (average score of 2 weeks) in Interference with Daily Activities estimated using a cLDA model, where both BL and post-BL measurements (average score from Day 1-Day 13) were included in the response variable. The treatment difference in terms of LS mean change from BL between desloratadine 5 mg and placebo evaluated with the 95% confidence interval and P-value."||-0.08|-0.26|<0.001
72612516|NCT02320396|144753845|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.492||||0.071|TWO_SIDED|95.0|0.966|2.303|||Regression, Logistic|||"Impression Rate as Assessed by Investigator: Desloratadine 5 mg/Placebo Odds Ratio~Impression was evaluated using a logistic model with impression rate (percentage of assessments of Better + Much better) as a response variable and treatment and severity as factors. Odds ratio was estimated and tested. A point estimate of \>1 indicated that desloratadine 5mg was more effective than placebo."||2.303|0.966|0.071
72612517|NCT02320396|144753846|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.149|||<|0.001|TWO_SIDED|95.0|1.408|3.28|||Regression, Logistic|||"Impression Rate as Assessed by Participant: Desloratadine 5 mg/Placebo Odds Ratio~Impression was evaluated using a logistic model with impression rate (percentage of assessments of Better + Much better) as a response variable and treatment and severity as factors. Odds ratio was estimated and tested. A point estimate of \>1 indicated that desloratadine 5mg was more effective than placebo"||3.280|1.408|<0.001
72612518|NCT03331562|144753847|SUPERIORITY||Risk Ratio (RR)|0.0||||0.31|ONE_SIDED|95.0|0.0||||Fisher Exact||Lower bound cannot be estimated because there were 0 events in the comparison group.||||0|.31
72612519|NCT00844519|144753883|SUPERIORITY_OR_OTHER|||||||0.17||||||significant at p\<0.05|t-test, 2 sided|||within-arm, pre-post change in FMD||||0.17
72612520|NCT00844519|144753883|SUPERIORITY_OR_OTHER|||||||0.9||||||significant at p\<0.05|t-test, 2 sided|||within-arm, pre-post change in FMD||||0.90
72612521|NCT01138735|144753885|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||No adjustment for multiplicity is required. The tests will be conducted as two-sided, each at the 0.05 significance level. The trial will be claimed 'positive' if all primary analyses are shown statistically significant at the 0.05 level.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel(CMH) test stratified by analysis center, using general association statistics||"null hypothesis: no difference in Success rate in two treatment groups (adapalene/benzoyl peroxide vs Topical Gel Vehicle).~power calculation: 90%"||||<0.001
72612522|NCT01138735|144753886|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||No adjustment for multiplicity is required. The tests will be conducted as two-sided, each at the 0.05 significance level. The trial will be claimed 'positive' if all primary analyses are shown statistically significant at the 0.05 level.|ANCOVA|normality assumption is not met. ANCOVA Model: Ranked Change in Total Lesion Counts = Ranked Baseline Lesion Counts, Analysis Center, Treatment.||null hypothesis: no difference in change from baseline in total lesion count in two treatment groups (adapalene/benzoyl peroxide vs Topical Gel Vehicle)||||<0.001
72326816|NCT01925768|144176936|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|12.7||||0.0392|TWO_SIDED|95.0|0.8|24.6||Two-sided p-value is based on the Cochran-Mantel-Haenszel test adjusting for previous DMARD use and baseline Oral Corticosteroids (Prednisone or equivalent) use.|Cochran-Mantel-Haenszel||Adjusted difference in proportions is the weighted average of the treatment differences across 4 strata by 2 stratification factors: previous DMARD use and baseline Corticosteroids use using CMH weights|Week 8; 2-sided 95% CI is based on a normal approximation to the weighted average||24.6|0.8|0.0392
72326817|NCT01925768|144176936|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|11.0||||0.0884|TWO_SIDED|95.0|-1.3|23.2||Two-sided p-value is based on the Cochran-Mantel-Haenszel test adjusting for previous DMARD use and baseline Oral Corticosteroids (Prednisone or equivalent) use.|Cochran-Mantel-Haenszel||Adjusted difference in proportions is the weighted average of the treatment differences across 4 strata by 2 stratification factors: previous DMARD use and baseline Corticosteroids use using CMH weights|Week 12; 2-sided 95% CI is based on a normal approximation to the weighted average||23.2|-1.3|0.0884
72612523|NCT01138735|144753887|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel|CMH test with row mean difference statistic using relative to an identified distribution(RIDIT) score, controlling for analysis center||||||<0.001
72612524|NCT01138735|144753888|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||ANCOVA|Ranked Change in Inflammatory Lesion Counts = Ranked Baseline Inflammatory Lesion Counts, Analysis Center, Treatment||||||<0.001
72612525|NCT01719653|144753940|OTHER||||||<|0.005||||||Chicago BPS Total Score -- 1 was lower than 3,4,5; 2 was lower than 5. Modified Chicago BPS Total Score -- 1 were lower than 5. Chicago BPS Fluid Score -- 1 was dryer than 3,4,5; 2 was dryer than 3,4,5; 3 was wetter than 4,5.|t-test, 2 sided|||"All 5 arms were compared pair-wise.~1=G+PEG-306 2=G+PEG-357 3=G+PEG-Split 4=PEG+Asc-Split 5=SS-Split"||||<0.005
72612526|NCT01719653|144753941|OTHER||||||<|0.001||||||1 was lower than 4,5.|t-test, 2 sided|||"All 5 arms were compared pair-wise.~1=G+PEG-306 2=G+PEG-357 3=G+PEG-Split 4=PEG+Asc-Split 5=SS-Split"||||<0.001
72612527|NCT01719653|144753942|OTHER||||||>|0.005|||||||Chi-squared|||All 5 arms were compared pair-wise.||||>0.005
72612528|NCT01811238|144753944|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.69|STANDARD_DEVIATION|2.18|<|0.05|TWO_SIDED|95.0|||||t-test, 2 sided|"The primary endpoint will be the actual reduction rate of pain intensity (0 -10) score at 8 weeks.~It will be analyzed by using paired t-test."||||||<0.05
72612529|NCT01811238|144753945|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.15|STANDARD_DEVIATION|0.37|<|0.05|TWO_SIDED|95.0|0.0|1.12|||t-test, 2 sided|The change(difference) in EQ-5D score at Week 8 from baseline was analyzed by using paired t-test.||||1.12|0|<0.05
72612530|NCT01192178|144753950|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.971||||0.928|TWO_SIDED|95.0|0.519|1.819||Cox Proportional Hazards model adjusted for investigative center|Regression, Cox||The risk of having an asthma exacerbation during the treatment period was analyzed.|||1.819|0.519|0.928
72612531|NCT02696798|144754002|SUPERIORITY||Odds Ratio (OR)|2.41||||0.017|TWO_SIDED|95.0|1.17|4.95|||Regression, Logistic|||||4.95|1.17|0.017
72612532|NCT02696798|144754002|SUPERIORITY||Odds Ratio (OR)|3.06||||0.003|TWO_SIDED|95.0|1.48|6.33|||Regression, Logistic|||||6.33|1.48|0.003
72612533|NCT02696798|144754003|SUPERIORITY||Odds Ratio (OR)|2.2||||0.006|TWO_SIDED|95.0|1.26|3.84|||Regression, Logistic|||||3.84|1.26|0.006
72612534|NCT02696798|144754003|SUPERIORITY||Odds Ratio (OR)|2.08||||0.013|TWO_SIDED|95.0|1.16|3.73|||Regression, Logistic|||||3.73|1.16|0.013
72612535|NCT02696798|144754004|SUPERIORITY||LS Mean Difference (Final Values)|-1.05|STANDARD_ERROR_OF_MEAN|0.135|<|0.001|TWO_SIDED|95.0|-1.32|-0.79|||Mixed Models Analysis|||||-0.79|-1.32|<0.001
72612536|NCT02696798|144754004|SUPERIORITY||LS Mean Difference (Final Values)|-1.03|STANDARD_ERROR_OF_MEAN|0.14|<|0.001|TWO_SIDED|95.0|-1.3|-0.75|||Mixed Models Analysis|||||-0.75|-1.30|<0.001
72612537|NCT02696798|144754005|SUPERIORITY||Odds Ratio (OR)|2.65||||0.015|TWO_SIDED|95.0|1.21|5.84|||Regression, Logistic|||||5.84|1.21|0.015
72612538|NCT02696798|144754005|SUPERIORITY||Odds Ratio (OR)|2.9||||0.01|TWO_SIDED|95.0|1.29|6.49|||Regression, Logistic|||||6.49|1.29|0.010
72612539|NCT02696798|144754006|SUPERIORITY||LS Mean Difference (Final Values)|-1.24|STANDARD_ERROR_OF_MEAN|0.291|<|0.001|TWO_SIDED|95.0|-1.81|-0.67|||Mixed Models Analysis|||||-0.67|-1.81|<0.001
72612540|NCT02696798|144754006|SUPERIORITY||LS Mean Difference (Final Values)|-1.16|STANDARD_ERROR_OF_MEAN|0.301|<|0.001|TWO_SIDED|95.0|-1.76|-0.57|||Mixed Models Analysis|||||-0.57|-1.76|<0.001
72612541|NCT02696798|144754007|SUPERIORITY||LS Mean Difference (Final Values)|-1.05|STANDARD_ERROR_OF_MEAN|0.295|<|0.001|TWO_SIDED|95.0|-1.63|-0.47|||Mixed Models Analysis|||||-0.47|-1.63|<0.001
72612542|NCT02696798|144754007|SUPERIORITY||LS Mean Difference (Final Values)|-1.28|STANDARD_ERROR_OF_MEAN|0.307|<|0.001|TWO_SIDED|95.0|-1.89|-0.68|||Mixed Models Analysis|||||-0.68|-1.89|<0.001
72612543|NCT02696798|144754008|SUPERIORITY||Odds Ratio (OR)|3.73||||0.242|TWO_SIDED|95.0|0.41|33.98|||Regression, Logistic|||||33.98|0.41|0.242
72612544|NCT02696798|144754008|SUPERIORITY||Odds Ratio (OR)|5.42||||0.127|TWO_SIDED|95.0|0.62|47.54|||Regression, Logistic|||||47.54|0.62|0.127
72612545|NCT02696798|144754009|SUPERIORITY||Odds Ratio (OR)|4.22||||0.006|TWO_SIDED|95.0|1.5|11.86|||Regression, Logistic|||||11.86|1.50|0.006
72612546|NCT02696798|144754009|SUPERIORITY||Odds Ratio (OR)|4.52||||0.006|TWO_SIDED|95.0|1.55|13.18|||Regression, Logistic|||||13.18|1.55|0.006
72612547|NCT02696798|144754010|SUPERIORITY||LS Mean Difference (Final Values)|0.7689|STANDARD_ERROR_OF_MEAN|1.2863||0.55|TWO_SIDED|95.0|-1.7629|3.3007|||Mixed Models Analysis|||MCS||3.3007|-1.7629|0.550
72612548|NCT02696798|144754010|SUPERIORITY||LS Mean Difference (Final Values)|0.9104|STANDARD_ERROR_OF_MEAN|1.3338||0.495|TWO_SIDED|95.0|-1.7151|3.536|||Mixed Models Analysis|||MCS||3.5360|-1.7151|0.495
72612549|NCT02696798|144754010|SUPERIORITY||LS Mean Difference (Final Values)|5.2147|STANDARD_ERROR_OF_MEAN|1.1149|<|0.001|TWO_SIDED|95.0|3.0204|7.409|||Mixed Models Analysis|||PCS||7.4090|3.0204|<0.001
72612550|NCT02696798|144754010|SUPERIORITY||LS Mean Difference (Final Values)|4.7585|STANDARD_ERROR_OF_MEAN|1.1505|<|0.001|TWO_SIDED|95.0|2.494|7.023|||Mixed Models Analysis|||PCS||7.0230|2.4940|<0.001
72612551|NCT02696798|144754011|SUPERIORITY||LS Mean Difference (Final Values)|-1.03|STANDARD_ERROR_OF_MEAN|0.46||0.026|TWO_SIDED|95.0|-1.94|-0.13|||Mixed Models Analysis|||||-0.13|-1.94|0.026
72612552|NCT02696798|144754011|SUPERIORITY||LS Mean Difference (Final Values)|-0.69|STANDARD_ERROR_OF_MEAN|0.477||0.149|TWO_SIDED|95.0|-1.63|0.25|||Mixed Models Analysis|||||0.25|-1.63|0.149
72612553|NCT02696798|144754012|SUPERIORITY||LS Mean Difference (Final Values)|-1.95|STANDARD_ERROR_OF_MEAN|0.512|<|0.001|TWO_SIDED|95.0|-3.0|-0.9|||ANCOVA|||||-0.9|-3.0|<0.001
72612554|NCT02696798|144754012|SUPERIORITY||LS Mean Difference (Final Values)|-2.17|STANDARD_ERROR_OF_MEAN|0.534|<|0.001|TWO_SIDED|95.0|-3.2|-1.1|||ANCOVA|||||-1.1|-3.2|<0.001
72612555|NCT02696798|144754013|SUPERIORITY||LS Mean Difference (Final Values)|-6.29|STANDARD_ERROR_OF_MEAN|1.896||0.001|TWO_SIDED|95.0|-10.0|-2.5|||ANCOVA|||||-2.5|-10.0|0.001
72612556|NCT02696798|144754013|SUPERIORITY||LS Mean Difference (Final Values)|-7.27|STANDARD_ERROR_OF_MEAN|1.978|<|0.001|TWO_SIDED|95.0|-11.2|-3.4|||ANCOVA|||||-3.4|-11.2|<0.001
72612557|NCT02696798|144754014|SUPERIORITY||LS Mean Difference (Final Values)|-20.816|STANDARD_ERROR_OF_MEAN|3.7463|<|0.001|TWO_SIDED|95.0|-28.187|-13.444|||Mixed Models Analysis|||||-13.444|-28.187|<0.001
72612558|NCT02696798|144754014|SUPERIORITY||LS Mean Difference (Final Values)|-17.841|STANDARD_ERROR_OF_MEAN|3.9018|<|0.001|TWO_SIDED|95.0|-25.518|-10.163|||Mixed Models Analysis|||||-10.163|-25.518|<0.001
72612559|NCT02696798|144754015|SUPERIORITY||LS Mean Difference (Final Values)|-0.304|STANDARD_ERROR_OF_MEAN|0.1275||0.018|TWO_SIDED|95.0|-0.555|-0.053|||Mixed Models Analysis|||||-0.053|-0.555|0.018
72612560|NCT02696798|144754015|SUPERIORITY||LS Mean Difference (Final Values)|-0.172|STANDARD_ERROR_OF_MEAN|0.1319||0.194|TWO_SIDED|95.0|-0.431|0.088|||Mixed Models Analysis|||||0.088|-0.431|0.194
72612561|NCT02696798|144754016|SUPERIORITY||LS Mean Difference (Final Values)|1.23|STANDARD_ERROR_OF_MEAN|0.893||0.17|TWO_SIDED|95.0|-0.53|2.99|||Mixed Models Analysis|||||2.99|-0.53|0.170
72612562|NCT02696798|144754016|SUPERIORITY||LS Mean Difference (Final Values)|0.23|STANDARD_ERROR_OF_MEAN|0.916||0.8|TWO_SIDED|95.0|-1.57|2.04|||Mixed Models Analysis|||||2.04|-1.57|0.800
72612563|NCT02696798|144754017|SUPERIORITY||LS Mean Difference (Final Values)|-0.31|STANDARD_ERROR_OF_MEAN|0.521||0.547|TWO_SIDED|95.0|-1.34|0.71|||Mixed Models Analysis|||||0.71|-1.34|0.547
72612564|NCT02696798|144754017|SUPERIORITY||LS Mean Difference (Final Values)|-1.0|STANDARD_ERROR_OF_MEAN|0.538||0.064|TWO_SIDED|95.0|-2.06|0.06|||Mixed Models Analysis|||||0.06|-2.06|0.064
72612565|NCT02696798|144754018|SUPERIORITY||LS Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.58||0.861|TWO_SIDED|95.0|-1.0|1.3|||Mixed Models Analysis|||||1.3|-1.0|0.861
72612566|NCT02696798|144754018|SUPERIORITY||LS Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.59||0.626|TWO_SIDED|95.0|-1.4|0.9|||Mixed Models Analysis|||||0.9|-1.4|0.626
72612567|NCT02696798|144754019|SUPERIORITY||LS Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.59||0.504|TWO_SIDED|95.0|-1.6|0.8|||Mixed Models Analysis|||||0.8|-1.6|0.504
72612568|NCT02696798|144754019|SUPERIORITY||LS Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.62||0.86|TWO_SIDED|95.0|-1.1|1.3|||Mixed Models Analysis|||||1.3|-1.1|0.860
72612569|NCT02696798|144754020|SUPERIORITY||LS Mean Difference (Final Values)|-0.9|STANDARD_ERROR_OF_MEAN|1.03||0.362|TWO_SIDED|95.0|-3.0|1.1|||Mixed Models Analysis|||||1.1|-3.0|0.362
72612570|NCT02696798|144754020|SUPERIORITY||LS Mean Difference (Final Values)|-1.1|STANDARD_ERROR_OF_MEAN|1.08||0.303|TWO_SIDED|95.0|-3.3|1.0|||Mixed Models Analysis|||||1.0|-3.3|0.303
72612571|NCT02696798|144754021|SUPERIORITY||LS Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.7||0.813|TWO_SIDED|95.0|-1.5|1.2|||Mixed Models Analysis|||||1.2|-1.5|0.813
72612572|NCT02696798|144754021|SUPERIORITY||LS Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.71||0.41|TWO_SIDED|95.0|-2.0|0.8|||Mixed Models Analysis|||||0.8|-2.0|0.410
72612573|NCT02696798|144754023|SUPERIORITY||LS Mean Difference (Final Values)|-1.2|STANDARD_ERROR_OF_MEAN|0.33|<|0.001|TWO_SIDED|95.0|-1.9|-0.6|||Mixed Models Analysis|||||-0.6|-1.9|<0.001
72612574|NCT02696798|144754023|SUPERIORITY||LS Mean Difference (Final Values)|-1.0|STANDARD_ERROR_OF_MEAN|0.34||0.005|TWO_SIDED|95.0|-1.6|-0.3|||Mixed Models Analysis|||||-0.3|-1.6|0.005
72612575|NCT02696798|144754024|SUPERIORITY||LS Mean Difference (Final Values)|-1.2|STANDARD_ERROR_OF_MEAN|0.68||0.088|TWO_SIDED|95.0|-2.5|0.2|||Mixed Models Analysis|||||0.2|-2.5|0.088
72612576|NCT02696798|144754024|SUPERIORITY||LS Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.7||0.366|TWO_SIDED|95.0|-2.0|0.7|||Mixed Models Analysis|||||0.7|-2.0|0.366
72612577|NCT02696798|144754025|SUPERIORITY||LS Mean Difference (Final Values)|-11.13|STANDARD_ERROR_OF_MEAN|5.323||0.038|TWO_SIDED|95.0|-21.65|-0.6|||ANCOVA|||Overall Work Impairment Score||-0.60|-21.65|0.038
72612578|NCT02696798|144754025|SUPERIORITY||LS Mean Difference (Final Values)|-13.66|STANDARD_ERROR_OF_MEAN|5.341||0.012|TWO_SIDED|95.0|-24.23|-3.1|||ANCOVA|||Overall Work Impairment Score||-3.10|-24.23|0.012
72612579|NCT02696798|144754025|SUPERIORITY||LS Mean Difference (Final Values)|-6.3|STANDARD_ERROR_OF_MEAN|3.5||0.071|TWO_SIDED|95.0|-13.2|0.5|||ANCOVA|||Percentage of Activity Impairment||0.5|-13.2|0.071
72612580|NCT02696798|144754025|SUPERIORITY||LS Mean Difference (Final Values)|-8.3|STANDARD_ERROR_OF_MEAN|3.65||0.024|TWO_SIDED|95.0|-15.5|-1.1|||ANCOVA|||Percentage of Activity Impairment||-1.1|-15.5|0.024
72612581|NCT03454555|144754030|SUPERIORITY||Mean Difference (Final Values)|-5.6||||0.31|TWO_SIDED|95.0|-16.6|5.3|||Mixed Models Analysis|||||5.3|-16.6|0.31
72612582|NCT03454555|144754031|SUPERIORITY||Mean Difference (Final Values)|0.3||||0.963|TWO_SIDED|95.0|-10.3|10.7|||Mixed Models Analysis|||||10.7|-10.3|0.963
72612583|NCT03454555|144754032|SUPERIORITY||Mean Difference (Final Values)|-6.2||||0.253|TWO_SIDED|95.0|-16.8|4.4|||Mixed Models Analysis|||||4.4|-16.8|0.253
72612584|NCT03454555|144754033|SUPERIORITY||Mean Difference (Final Values)|0.7||||0.9|TWO_SIDED|95.0|-10.1|11.5|||Mixed Models Analysis|||||11.5|-10.1|0.90
72612585|NCT03454555|144754034|SUPERIORITY||Mean Difference (Final Values)|-2.6||||0.65|TWO_SIDED|95.0|-13.7|8.6|||Mixed Models Analysis|||||8.6|-13.7|0.65
72612586|NCT03454555|144754035|SUPERIORITY||Mean Difference (Final Values)|9.4||||0.102|TWO_SIDED|95.0|-1.9|20.8|||Mixed Models Analysis|||||20.8|-1.9|0.102
72612587|NCT03454555|144754036|SUPERIORITY||Odds Ratio (OR)|0.93||||0.83|TWO_SIDED|95.0|0.5|1.75|||Mixed Models Analysis|Used a logistic mixed model for repeated measures||||1.75|0.50|0.83
72612588|NCT03454555|144754037|SUPERIORITY||Odds Ratio (OR)|0.79||||0.47|TWO_SIDED|95.0|0.42|1.5|||Mixed Models Analysis|Used a logistic mixed model for repeated measures||||1.50|0.42|0.47
72612589|NCT03454555|144754038|SUPERIORITY||Odds Ratio (OR)|1.02||||0.96|TWO_SIDED|95.0|0.54|1.9|||Mixed Models Analysis|Used a logistic mixed model for repeated measures||||1.90|0.54|0.96
72326818|NCT01925768|144176936|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|18.6||||0.004|TWO_SIDED|95.0|6.5|30.7||Two-sided p-value is based on the Cochran-Mantel-Haenszel test adjusting for previous DMARD use and baseline Oral Corticosteroids (Prednisone or equivalent) use.|Cochran-Mantel-Haenszel||Adjusted difference in proportions is the weighted average of the treatment differences across 4 strata by 2 stratification factors: previous DMARD use and baseline Corticosteroids use using CMH weights|Week 20; 2-sided 95% CI is based on a normal approximation to the weighted average||30.7|6.5|0.0040
72326819|NCT05501639|144176953|OTHER|||||||0.758|||||||Log Rank|||||||0.758
72326820|NCT05501639|144176954|OTHER|||||||0.474|||||||Log Rank|||||||0.474
72612590|NCT03454555|144754039|SUPERIORITY||Odds Ratio (OR)|0.71||||0.28|TWO_SIDED|95.0|0.38|1.33|||Mixed Models Analysis|Used a logistic mixed model for repeated measures||||1.33|0.38|0.28
72612591|NCT03454555|144754040|SUPERIORITY||Odds Ratio (OR)|0.9||||0.75|TWO_SIDED|95.0|0.47|1.71|||Mixed Models Analysis|Used a logistic mixed model for repeated measures||||1.71|0.47|0.75
72612592|NCT03454555|144754041|SUPERIORITY||Odds Ratio (OR)|0.68||||0.25|TWO_SIDED|95.0|0.35|1.31|||Mixed Models Analysis|Used a logistic mixed model for repeated measures||||1.31|0.35|0.25
72612593|NCT03454555|144754042|SUPERIORITY||Mean Difference (Final Values)|0.3||||0.7|TWO_SIDED|95.0|-0.9|1.4|||Mixed Models Analysis|||||1.4|-0.9|0.70
72612594|NCT03454555|144754043|SUPERIORITY||Median Difference (Final Values)|0.1||||0.92|TWO_SIDED|95.0|-1.1|1.2|||Mixed Models Analysis|||||1.2|-1.1|0.92
72612595|NCT03454555|144754044|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.64|TWO_SIDED|95.0|-0.7|1.2|||Mixed Models Analysis|||||1.2|-0.7|0.64
72612596|NCT03454555|144754045|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.75|TWO_SIDED|95.0|-0.8|1.1|||Mixed Models Analysis|||||1.1|-0.8|0.75
72612597|NCT03454555|144754046|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.69|TWO_SIDED|95.0|-0.9|1.4|||Mixed Models Analysis|||||1.4|-0.9|0.69
72612598|NCT03454555|144754047|SUPERIORITY||Mean Difference (Final Values)|0.6||||0.33|TWO_SIDED|95.0|-0.6|1.8|||Mixed Models Analysis|||||1.8|-0.6|0.33
72612599|NCT03454555|144754048|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.86|TWO_SIDED|95.0|-1.8|1.5|||Mixed Models Analysis|||||1.5|-1.8|0.86
72612600|NCT03454555|144754049|SUPERIORITY||Mean Difference (Final Values)|0.3||||0.76|TWO_SIDED|95.0|-1.4|1.9|||Mixed Models Analysis|||||1.9|-1.4|0.76
72612601|NCT03454555|144754050|SUPERIORITY||Mean Difference (Final Values)|-0.5||||0.55|TWO_SIDED|95.0|-2.0|1.1|||Mixed Models Analysis|||||1.1|-2.0|0.55
72612602|NCT03454555|144754051|SUPERIORITY||Mean Difference (Final Values)|-0.5||||0.52|TWO_SIDED|95.0|-2.1|1.1|||Mixed Models Analysis|||||1.1|-2.1|0.52
72612603|NCT03454555|144754052|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.37|TWO_SIDED|95.0|-0.2|0.4|||Mixed Models Analysis|||||0.4|-0.2|0.37
72326821|NCT05501639|144176955|OTHER|||||||0.472|||||||Chi-squared|||||||0.472
72326822|NCT05501639|144176956|OTHER||Incidence rate ratio|0.647|||||TWO_SIDED|95.0|0.261|1.604|||||Incidence rate ratio at 6 months|||1.604|0.261|
72326823|NCT05501639|144176956|OTHER||Incidence rate ratio|1.005|||||TWO_SIDED|95.0|0.513|1.969|||||Incidence rate ratio at 12 months|||1.969|0.513|
72612604|NCT03454555|144754053|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.91|TWO_SIDED|95.0|-0.3|0.3|||Mixed Models Analysis|||||0.3|-0.3|0.91
72612605|NCT03454555|144754054|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.33|TWO_SIDED|95.0|-0.2|0.6|||Mixed Models Analysis|||||0.6|-0.2|0.33
72612606|NCT03454555|144754055|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.46|TWO_SIDED|95.0|-0.3|0.6|||Mixed Models Analysis|||||0.6|-0.3|0.46
72612607|NCT03454555|144754056|SUPERIORITY||Risk Difference (RD)|-0.02||||0.52|TWO_SIDED|95.0|-0.08|0.04|||Chi-squared|||||0.04|-0.08|0.52
72612608|NCT03454555|144754057|SUPERIORITY||Odds Ratio (OR)|1.48||||0.17|TWO_SIDED|95.0|0.85|2.59|||Mixed Models Analysis|Used a generalized logistic model for repeated measurements; modeled the outcome of intention to taper.||||2.59|0.85|0.17
72612609|NCT03454555|144754058|SUPERIORITY||Odds Ratio (OR)|1.28||||0.41|TWO_SIDED|95.0|0.71|2.31|||Mixed Models Analysis|Used a generalized logistic model for repeated measurements; modeled the outcome of intention to taper.||||2.31|0.71|0.41
72612610|NCT03454555|144754059|SUPERIORITY|||||||0.79|||||||Chi-squared|||||||0.79
72612611|NCT03454555|144754060|SUPERIORITY|||||||0.67|||||||Chi-squared|||||||0.67
72612612|NCT03675308|144754089|SUPERIORITY||Response Rate Difference|24.0|||<|0.001|TWO_SIDED|95.0|18.0|30.0||All primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment via a fixed sequence testing procedure to control the family-wise type I error rate at α=0.05 (two- sided).|Cochran-Mantel-Haenszel|CMH test adjusted for the stratification factors of current csDMARD use, presence of dactylitis, enthesitis and extent of psoriasis at Baseline.|Response Rate Difference = Risankizumab - Placebo|The comparison between the risankizumab and placebo treatment groups for the primary efficacy endpoint (ACR20 at Week 24) was performed using the Cochran-Mantel-Haenszel (CMH) test adjusting for the stratification factors of baseline psoriasis (≥ 3%/\< 3% body surface area), presence of dactylitis (yes/no), presence of enthesitis (yes/no) and current csDMARD use (0/≥ 1).||30.0|18.0|<0.001
72612613|NCT03675308|144754090|SUPERIORITY||Least Squares (LS) Mean Difference|-0.2|||<|0.001|TWO_SIDED|95.0|-0.26|-0.14||All primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment via a fixed sequence testing procedure to control the family-wise type I error rate at α=0.05 (two- sided).|Mixed Effect Model Repeated Measurement|MMRM analysis including treatment, visit, treatment-by-visit interaction, and stratification factors as fixed factors and Baseline value as covariate.|Difference = Risankizumab - Placebo|||-0.14|-0.26|<0.001
72612614|NCT03675308|144754091|SUPERIORITY||Response Rate Difference|42.5|||<|0.001|TWO_SIDED|95.0|35.6|49.3||All primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment via a fixed sequence testing procedure to control the family-wise type I error rate at α=0.05 (two- sided).|Cochran-Mantel-Haenszel|CMH test adjusted for the stratification factors of current csDMARD use, presence of dactylitis, enthesitis and extent of psoriasis at Baseline.|Response Rate Difference = Risankizumab - Placebo|||49.3|35.6|<0.001
72612615|NCT03675308|144754092|SUPERIORITY||Response Rate Difference|23.1|||<|0.001|TWO_SIDED|95.0|16.8|29.4||All primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment via a fixed sequence testing procedure to control the family-wise type I error rate at α=0.05 (two- sided).|Cochran-Mantel-Haenszel|CMH test adjusted for the stratification factors of current csDMARD use, presence of dactylitis, enthesitis and extent of psoriasis at Baseline.|Response Rate Difference = Risankizumab - Placebo|||29.4|16.8|<0.001
72612616|NCT03675308|144754093|SUPERIORITY||Response Rate Difference|14.8|||<|0.001|TWO_SIDED|95.0|10.2|19.4||All primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment via a fixed sequence testing procedure to control the family-wise type I error rate at α=0.05 (two- sided).|Cochran-Mantel-Haenszel|CMH test adjusted for the stratification factors of current csDMARD use, presence of dactylitis, enthesitis and extent of psoriasis at Baseline.|Response Rate Difference = Risankizumab - Placebo|||19.4|10.2|<0.001
72612617|NCT03675308|144754094|SUPERIORITY||LS Mean Difference|-4.19|||<|0.001|TWO_SIDED|95.0|-5.7|-2.68||All primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment via a fixed sequence testing procedure to control the family-wise type I error rate at α=0.05 (two- sided).|Mixed Effect Model Repeated Measurement|MMRM analysis including treatment, visit, treatment-by-visit interaction, and stratification factors as fixed factors and Baseline value as covariate.|Difference = Risankizumab - Placebo|||-2.68|-5.70|<0.001
72612618|NCT03675308|144754095|SUPERIORITY||LS Mean Difference|-0.4|||<|0.001|TWO_SIDED|95.0|-0.6|-0.3||All primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment via a fixed sequence testing procedure to control the family-wise type I error rate at α=0.05 (two- sided).|Mixed Effect Model Repeated Measurement|MMRM analysis including treatment, visit, treatment-by-visit interaction, and stratification factors as fixed factors and Baseline value as covariate.|Difference = Risankizumab - Placebo|||-0.3|-0.6|<0.001
72612619|NCT03675308|144754096|SUPERIORITY||Response Rate Difference|13.9|||<|0.001|TWO_SIDED|95.0|7.6|20.2||All primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment via a fixed sequence testing procedure to control the family-wise type I error rate at α=0.05 (two- sided).|Cochran-Mantel-Haenszel|CMH test adjusted for the stratification factors of current csDMARD use and extent of psoriasis at Baseline and study.|Response Rate Difference = Risankizumab - Placebo|The pre-specified analysis for the resolution of enthesitis included pooled data from KEEPsAKE 1 (this study) and KEEPsAKE 2 (M15-998; NCT03671148).||20.2|7.6|<0.001
72612620|NCT03675308|144754097|SUPERIORITY||Response Rate Difference|16.9|||<|0.001|TWO_SIDED|95.0|7.5|26.4||All primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment via a fixed sequence testing procedure to control the family-wise type I error rate at α=0.05 (two- sided).|Cochran-Mantel-Haenszel|CMH test adjusted for the stratification factors of current csDMARD use, extent of psoriasis at Baseline, and study.|Response Rate Difference = Risankizumab - Placebo|The pre-specified analysis for the resolution of dactylitis included pooled data from KEEPsAKE 1 (this study) and KEEPsAKE 2 (M15-998; NCT03671148).||26.4|7.5|<0.001
72612621|NCT03675308|144754098|SUPERIORITY||LS Mean Difference|-0.09||||0.496|TWO_SIDED|95.0|-0.36|0.17||All primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment via a fixed sequence testing procedure to control the family-wise type I error rate at α=0.05 (two- sided).|ANCOVA|ANCOVA model including treatment and the stratification factors and baseline value as covariates.|Difference = Risankizumab - Placebo|||0.17|-0.36|0.496
72612622|NCT03675308|144754099|OTHER||LS Mean Difference|3.32|||<|0.001|TWO_SIDED|95.0|2.42|4.22||This comparison was not tested for statistical significance because the hierarchical testing procedures stopped at the change from Baseline in PsA-mTSS comparison.|Mixed Effect Model Repeated Measurement|MMRM analysis including treatment, visit, treatment-by-visit interaction, and stratification factors as fixed factors and Baseline value as covariate.|Difference = Risankizumab - Placebo|||4.22|2.42|<0.001
72612623|NCT03675308|144754100|OTHER||LS Mean Difference|2.6|||<|0.001|TWO_SIDED|95.0|1.5|3.7||This comparison was not tested for statistical significance because the hierarchical testing procedures stopped at the change from Baseline in PsA-mTSS comparison.|Mixed Effect Model Repeated Measurement|MMRM analysis including treatment, visit, treatment-by-visit interaction, and stratification factors as fixed factors and Baseline value as covariate.|Difference = Risankizumab - Placebo|||3.7|1.5|<0.001
72612624|NCT03675308|144754101|SUPERIORITY||Response Rate Difference|22.2|||<|0.001|TWO_SIDED|95.0|17.3|27.2|||Cochran-Mantel-Haenszel|CMH test adjusted for the stratification factors of current csDMARD use, presence of dactylitis, enthesitis and extent of psoriasis at Baseline.|Response Rate Difference = Risankizumab - Placebo|||27.2|17.3|<0.001
72612625|NCT03675308|144754102|SUPERIORITY||Response Rate Difference|10.5|||<|0.001|TWO_SIDED|95.0|6.9|14.2|||Cochran-Mantel-Haenszel|CMH test adjusted for the stratification factors of current csDMARD use, presence of dactylitis, enthesitis and extent of psoriasis at Baseline.|Response Rate Difference = Risankizumab - Placebo|||14.2|6.9|<0.001
72326824|NCT05501639|144176957|OTHER|||||||0.222|||||||Chi-squared|||Hospitalisations||||0.222
72326825|NCT05501639|144176957|OTHER|||||||0.553|||||||Chi-squared|||Asthma-related hospitalisations||||0.553
72326826|NCT05501639|144176957|OTHER|||||||0.192|||||||Chi-squared|||ED visits||||0.192
72326827|NCT05501639|144176957|OTHER|||||||0.383|||||||Chi-squared|||Asthma-related ED visits||||0.383
72612626|NCT03405870|144754132|OTHER|Determined maximum tolerated dose|Value of Maximum Tolerated Dose (g/kg)|1.6|||||TWO_SIDED|||||||||Using sequential dose escalation, participants received 2 doses of 1.0 to 1.6 g/kg of lipid emulsion (Smoflipid 20% lipid emulsion) within 48 hours of enrollment to test the maximum tolerated dose of study drug. The maximum tolerated dose was defined by patients exhibiting specific dose-related toxicities from administration of escalating doses of the study drug. Of 9 patients, adverse events were only considered dose-limiting toxicities if they met the predefined study protocol criteria.||||
72326828|NCT05501639|144176957|OTHER|||||||0.338|||||||Chi-squared|||OP visits||||0.338
72326829|NCT05501639|144176957|OTHER||||||<|0.0001|||||||Chi-squared|||Asthma-related OP visits||||<0.0001
72612627|NCT05172609|144754134|EQUIVALENCE|Margin difference of 1 standard deviation (SD) or higher was considered evidence of non-equivalence comparison||||||0.47|||||||t-test, 2 sided|||T-tests between EBIS and IAU conditions at 12-week follow up for AIM||||.47
72612628|NCT05172609|144754135|EQUIVALENCE|Margin difference of 1 SD or higher was considered evidence of non-equivalence comparison||||||0.88|||||||t-test, 2 sided|||T-tests between EBIS and IAU conditions at 12-week follow up for FIM||||.88
72612629|NCT05172609|144754136|SUPERIORITY|||||||0.46|||||||t-test, 2 sided|||Test of superiority between EBIS and IAU groups comparing SUDS screening rating at Time 3: two weeks after completing the training||||.46
72612630|NCT05172609|144754136|SUPERIORITY|||||||0.4|||||||t-test, 2 sided|||Test of superiority between EBIS and IAU groups comparing SUDS screening rating at Time 4: 12 weeks after completing the training||||.40
72612631|NCT05172609|144754136|SUPERIORITY|||||||0.56|||||||t-test, 2 sided|||Test of superiority between EBIS and IAU groups comparing SUDS planning rating at Time 3: two weeks after completing the training||||.56
72612632|NCT05172609|144754136|SUPERIORITY|||||||0.68|||||||t-test, 2 sided|||Test of superiority between EBIS and IAU groups comparing SUDS planning rating at Time 4: 12 weeks after completing the training||||.68
72612633|NCT05172609|144754136|SUPERIORITY|||||||0.87|||||||ANCOVA|||Repeated measures analysis of covariance (ANCOVA), controlling for organization: SUDS screening at timepoints 1, 3, and 4||||.87
72612634|NCT05172609|144754136|SUPERIORITY|||||||0.43|||||||ANCOVA|||repeated measures analysis of covariance (ANCOVA), controlling for organization: SUDS planning at timepoints 1, 3, and 4||||.43
72612635|NCT05172609|144754137|SUPERIORITY|||||||0.59|||||||t-test, 2 sided|||Test of superiority between EBIS and IAU groups comparing screening self-efficacy rating at Time 3: two weeks after completing the training||||.59
72612636|NCT05172609|144754137|SUPERIORITY|||||||0.59|||||||t-test, 2 sided|||Test of superiority between EBIS and IAU groups comparing screening self-efficacy rating at Time 4: 12 weeks after completing the training||||.59
72612637|NCT05172609|144754137|SUPERIORITY|||||||0.25|||||||t-test, 2 sided|||Test of superiority between EBIS and IAU groups comparing intervening self-efficacy rating at Time 3: two weeks after completing the training||||.25
72612638|NCT05172609|144754137|SUPERIORITY|||||||0.35|||||||t-test, 2 sided|||Test of superiority between EBIS and IAU groups comparing intervening self-efficacy rating at Time 4: 12 weeks after completing the training||||.35
72612639|NCT05172609|144754137|SUPERIORITY|||||||0.88|||||||ANCOVA|||repeated measures analysis of covariance (ANCOVA), controlling for organization: Self-efficacy screening at timepoints 1, 3, and 4||||.88
72612640|NCT05172609|144754137|SUPERIORITY|||||||0.71|||||||ANCOVA|||repeated measures analysis of covariance (ANCOVA), controlling for organization: Self-efficacy intervening at timepoints 1, 3, and 4||||.71
72326830|NCT05501639|144176958|OTHER|||||||0.538|||||||t-test, 2 sided|||Hospitalisations||||0.538
72326831|NCT05501639|144176958|OTHER|||||||0.913|||||||t-test, 2 sided|||Asthma-related hospitalisations||||0.913
72326832|NCT05501639|144176958|OTHER|||||||0.688|||||||t-test, 2 sided|||ED visits||||0.688
72326833|NCT05501639|144176958|OTHER|||||||0.892|||||||t-test, 2 sided|||Asthma-related ED visits||||0.892
72326834|NCT05501639|144176958|OTHER||||||<|0.0001|||||||t-test, 2 sided|||OP visits||||<0.0001
72326835|NCT05501639|144176958|OTHER|||||||0.002|||||||t-test, 2 sided|||Asthma-related OP visits||||0.002
72326836|NCT05501639|144176959|OTHER|||||||0.378|||||||Chi-squared|||||||0.378
72326837|NCT04571060|144176968|SUPERIORITY|The stratified percentage difference between zavegepant group and placebo was tested at an alpha level of 0.05.|Stratified Percentage Difference|8.8|||<|0.0001|TWO_SIDED|95.0|4.5|13.1||Threshold for significance at 0.05.|Cochran-Mantel-Haenszel|||||13.1|4.5|<0.0001
72612641|NCT05172609|144754138|SUPERIORITY|||||||0.88|||||||t-test, 2 sided|||Test of superiority between EBIS and IAU groups comparing screening use at Time 3: two weeks after completing the training||||.88
72612642|NCT05172609|144754138|SUPERIORITY|||||||0.55|||||||t-test, 2 sided|||Test of superiority between EBIS and IAU groups comparing screening use at Time 4: 12 weeks after completing the training||||.55
72612643|NCT05172609|144754138|SUPERIORITY|||||||0.36|||||||ANCOVA|||repeated measures analysis of covariance (ANCOVA), controlling for organization: CSR screening at timepoints 1, 3, and 4||||.36
72612644|NCT05172609|144754139|SUPERIORITY|||||||0.24|||||||t-test, 2 sided|||Test of superiority between EBIS and IAU groups comparing total SPIRS score at Time 3: two weeks after completing the training||||.24
72612645|NCT05172609|144754139|SUPERIORITY|||||||0.88|||||||t-test, 2 sided|||Test of superiority between EBIS and IAU groups comparing total SPIRS score at Time 4: 12 weeks after completing the training||||.88
72612646|NCT05172609|144754139|SUPERIORITY|||||||0.1|||||||ANCOVA|||repeated measures analysis of covariance (ANCOVA), controlling for organization: SPIRS at timepoints 3 and 4||||.10
72612647|NCT00614393|144754179|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.41||||0.06|TWO_SIDED|95.0|0.99|2.0|||Regression, Cox|||||2.00|0.99|0.06
72612648|NCT00614393|144754179|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.26||||0.18|TWO_SIDED|95.0|0.89|1.79|||Regression, Cox|||||1.79|0.89|0.18
72612649|NCT00614393|144754180|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.33||||0.07|TWO_SIDED|95.0|0.98|1.83|||Regression, Cox|||||1.83|0.98|0.07
72612650|NCT00614393|144754180|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.13||||0.44|TWO_SIDED|95.0|0.83|1.55|||Regression, Cox|||||1.55|0.83|0.44
72326838|NCT04571060|144176969|SUPERIORITY|The stratified percentage difference between zavegepant group and placebo was tested at an alpha level of 0.05.|Stratified Percentage Difference|8.7||||0.0012|TWO_SIDED|95.0|3.4|13.9||Threshold for significance at 0.05.|Cochran-Mantel-Haenszel|||||13.9|3.4|0.0012
72326839|NCT04571060|144176970|SUPERIORITY|The stratified percentage difference between zavegepant group and placebo was tested at an alpha level of 0.05.|Stratified Percentage Difference|9.0||||0.0012|TWO_SIDED|95.0|3.6|14.5||Threshold for significance at 0.05.|Cochran-Mantel-Haenszel|||||14.5|3.6|0.0012
72326840|NCT04571060|144176971|SUPERIORITY|The stratified percentage difference between zavegepant group and placebo was tested at an alpha level of 0.05.|Stratified Percentage Difference|10.2||||0.0001|TWO_SIDED|95.0|5.0|15.5||Threshold for significance at 0.05.|Cochran-Mantel-Haenszel|||||15.5|5.0|0.0001
72612651|NCT02328105|144754186|SUPERIORITY|Assuming the true overall response rate is 0.20 under the null hypothesis, then this design will provide 81% power to detect a difference of 0.15 under the alternative hypothesis, assuming a one-sided alpha = 0.09 significance level. A three stage design with n=15, 30 and 45 subjects was determined with the following rejection regions: For n = 15, the rejection region in number of responses (CR or PR) is 0 - 2, for n = 30 it is 3 - 6, and for n = 45 it is 7 - 12.|Response Rate|0.364||||0.161|TWO_SIDED|95.0|0.109|0.692||This p-value is only based on partial enrollment of stage 1. As enrollment was halted early, this p-value is descriptive in nature and cannot determine the success/failure of the trial.|Fisher Exact||Confidence interval estimated using the Clopper Pearson method.|||0.692|0.109|0.161
72612652|NCT02328105|144754187|OTHER|Estimation only.|Disease Control Rate|0.818|||||TWO_SIDED|95.0|0.482|0.977|||||Confidence interval estimated using the Clopper Pearson method.|||0.977|0.482|
72612653|NCT02328105|144754188|OTHER|Estimation only.|Median|7.3|||||TWO_SIDED|95.0|2.2|13.0|||||The Kaplan Meier method was used to estimate the median PFS(in months) for the population. The Greenwood method was used to estimate the confidence limits of the median progression free survival.|||13.0|2.2|
72612654|NCT02328105|144754189|OTHER|Estimation only.|Median|30.0|||||TWO_SIDED|95.0|2.2||Upper limit of the confidence interval is not reached due to censoring rate.||||The Kaplan Meier method was used to estimate median OS(in months). The Greenwood method was used to estimate confidence limits of median overall survival.||||2.2|
72612655|NCT02328105|144754190|OTHER|Estimation only.|Median|10.8|||||TWO_SIDED|95.0|4.9|11.9|||||The Kaplan Meier method was used to estimate median duration of response (in months). The Greenwood method was used to estimate confidence limits of median duration of response.|||11.9|4.9|
72612656|NCT02328105|144754191|OTHER|Estimation only.|Median|7.3|||||TWO_SIDED|95.0|3.0|13.0|||||The Kaplan Meier method was used to estimate median duration of disease control (in months). The Greenwood method was used to estimate confidence limits of median disease control duration.|||13.0|3.0|
72612657|NCT01588509|144754194|SUPERIORITY||Percent Change from Baseline|2.13||||0.002|TWO_SIDED|90.0|1.05|3.2|||ANOVA|||||3.20|1.05|0.002
72612658|NCT01588509|144754194|SUPERIORITY||Percent Change from Baseline|2.08||||0.002|TWO_SIDED|90.0|1.02|3.14|||ANOVA|||||3.14|1.02|0.002
72612659|NCT01588509|144754195|SUPERIORITY||Percent Change from Baseline|2.06|||<|0.001|TWO_SIDED|90.0|1.07|3.05|||ANOVA|||||3.05|1.07|<0.001
72612660|NCT01588509|144754195|SUPERIORITY||Percent Change from Baseline|1.92||||0.002|TWO_SIDED|90.0|0.95|2.89|||ANOVA|||||2.89|0.95|0.002
72612661|NCT01588509|144754196|SUPERIORITY||Percent Change from Baseline|1.38|||<|0.001|TWO_SIDED|90.0|0.81|1.95|||ANOVA|||||1.95|0.81|<0.001
72612662|NCT01588509|144754196|SUPERIORITY||Percent Change from Baseline|1.4|||<|0.001|TWO_SIDED|90.0|0.84|1.96|||ANOVA|||||1.96|0.84|<0.001
72612663|NCT00855582|144754202|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-2.3|STANDARD_ERROR_OF_MEAN|0.58|<|0.001||95.0||||Statistical significance was assessed using a Dunnett-Bonferroni gatekeeping procedure for multiple hypothesis testing. The pre-specified alpha level of 0.0271 was used.|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.||||||<0.001
72612664|NCT00855582|144754203|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.7|STANDARD_ERROR_OF_MEAN|0.66|<|0.001||95.0||||Statistical significance was assessed using a Dunnett-Bonferroni gatekeeping procedure for multiple hypothesis testing. The pre-specified alpha level of 0.0271 was used.|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.||||||<0.001
72612665|NCT00855582|144754204|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8|STANDARD_ERROR_OF_MEAN|0.59||0.181||95.0||||Statistical significance was assessed using a Dunnett-Bonferroni gatekeeping procedure for multiple hypothesis testing. The pre-specified alpha level of 0.0271 was used.|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.||||||0.181
72612666|NCT00855582|144754205|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.4|STANDARD_ERROR_OF_MEAN|0.67|<|0.001||95.0||||Statistical significance was assessed using a Dunnett-Bonferroni gatekeeping procedure for multiple hypothesis testing. The pre-specified alpha level of 0.0271 was used.|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.||||||<0.001
72326841|NCT04571060|144176972|SUPERIORITY|The stratified percentage difference between zavegepant group and placebo was tested at an alpha level of 0.05.|Stratified Percentage Difference|7.6||||0.0048|TWO_SIDED|95.0|2.3|12.9||Threshold for significance at 0.05.|Cochran-Mantel-Haenszel|||||12.9|2.3|0.0048
72326842|NCT04571060|144176973|SUPERIORITY|The stratified percentage difference between zavegepant group and placebo was tested at an alpha level of 0.05.|Stratified Percentage Difference|6.5||||0.013|TWO_SIDED|95.0|1.4|11.7||Threshold for significance at 0.05.|Cochran-Mantel-Haenszel|||||11.7|1.4|0.0130
72612667|NCT00855582|144754206|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|19.7|STANDARD_ERROR_OF_MEAN|2.8|<|0.001||95.0||||Statistical significance was assessed using a Dunnett-Bonferroni gatekeeping procedure for multiple hypothesis testing. The pre-specified alpha level of 0.0228 was used.|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.||||||<0.001
72326843|NCT04571060|144176974|SUPERIORITY|The stratified percentage difference between zavegepant group and placebo was tested at an alpha level of 0.05.|Stratified Percentage Difference|4.9||||0.0076|TWO_SIDED|95.0|1.3|8.5||Threshold for significance at 0.05.|Cochran-Mantel-Haenszel|||||8.5|1.3|0.0076
72326844|NCT04571060|144176975|SUPERIORITY|The stratified percentage difference between zavegepant group and placebo was tested at an alpha level of 0.05.|Stratified Percentage Difference|3.7||||0.0308|TWO_SIDED|95.0|0.3|7.1||Threshold for significance at 0.05.|Cochran-Mantel-Haenszel|||||7.1|0.3|0.0308
72326845|NCT04571060|144176976|SUPERIORITY|The stratified percentage difference between zavegepant group and placebo was tested at an alpha level of 0.05.|Stratified Percentage Difference|8.3||||0.0123|TWO_SIDED|95.0|1.8|14.9||Threshold for significance at 0.05.|Cochran-Mantel-Haenszel|||||14.9|1.8|0.0123
72326846|NCT04571060|144176977|SUPERIORITY|The stratified percentage difference between zavegepant group and placebo was tested at an alpha level of 0.05.|Stratified Percentage Difference|8.6||||0.0018|TWO_SIDED|95.0|3.2|14.1||Threshold for significance at 0.05.|Cochran-Mantel-Haenszel|||||14.1|3.2|0.0018
72326847|NCT04571060|144176978|SUPERIORITY|The stratified percentage difference between zavegepant group and placebo was tested at an alpha level of 0.05.|Stratified Percentage Difference|6.0||||0.0293|TWO_SIDED|95.0|0.6|11.4||Threshold for significance at 0.05.|Cochran-Mantel-Haenszel|||||11.4|0.6|0.0293
72326848|NCT04571060|144176979|SUPERIORITY|The stratified percentage difference between zavegepant group and placebo was tested at an alpha level of 0.05.|Stratified Percentage Difference|4.7||||0.0362|TWO_SIDED|95.0|0.3|9.1||Threshold for significance at 0.05.|Cochran-Mantel-Haenszel|||||9.1|0.3|0.0362
72326849|NCT04571060|144176980|SUPERIORITY|The stratified percentage difference between zavegepant group and placebo was tested at an alpha level of 0.05.|Stratified Percentage Difference|10.2|||<|0.0001|TWO_SIDED|95.0|5.5|15.0||Threshold for significance at 0.05.|Cochran-Mantel-Haenszel|||||15.0|5.5|<0.0001
72326850|NCT04571060|144176981|SUPERIORITY|The stratified percentage difference between zavegepant group and placebo was tested at an alpha level of 0.05.|Stratified Percentage Difference|4.4||||0.0059|TWO_SIDED|95.0|1.3|7.6||Threshold for significance at 0.05.|Cochran-Mantel-Haenszel|||||7.6|1.3|0.0059
72326851|NCT04571060|144176982|SUPERIORITY|The stratified percentage difference between zavegepant group and placebo was tested at an alpha level of 0.05.|Stratified Percentage Difference|7.8|||<|0.0001|TWO_SIDED|95.0|4.2|11.3||Threshold for significance at 0.05.|Cochran-Mantel-Haenszel|||||11.3|4.2|<0.0001
72326852|NCT01361217|144177007|SUPERIORITY_OR_OTHER||||||>|0.05|||||||t-test, 2 sided|||||||>0.05
72326853|NCT01361217|144177007|OTHER||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
72326854|NCT01361217|144177008|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
72326855|NCT04970069|144177044|SUPERIORITY||Ratio of geometric means|1.01||||0.89|TWO_SIDED|95.0|0.86|1.18|||Regression, Linear||The numerator and denominator for the ratio of geometric means are analgesic education and general preoperative education respectively.|Multiple imputation by chained equations (MICE) was used for imputing missing outcomes and covariates.||1.18|0.86|0.890
72326856|NCT04970069|144177045|SUPERIORITY||Median Difference (Final Values)|-0.1||||0.617|TWO_SIDED|95.0|-0.3|0.2|||Regression, Linear|||||0.2|-0.3|0.617
72326857|NCT04970069|144177046|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.611|TWO_SIDED|95.0|-0.3|0.2|||Regression, Linear|||||0.2|-0.3|0.611
72326858|NCT00142792|144177047|SUPERIORITY_OR_OTHER|||||||0.18||||||Time by group interaction effect, F(2,372) = 1.8, p =0.18)|Mixed Models Analysis|A random intercept for each participant with a first-order antedependent covariance structure. Adjusted for site.||The study was powered to detect differences in FMA scores of a minimum effect size of 0.8 at a significance level of 0.01, the smallest effect size difference anticipated between Cyclic NMES and Cyclic Sensory Stimulation based on prior studies. A significance level of 0.01 in the power-analysis was taken since for each measurement occasion, three post-hoc tests are needed. To account for drop out of 20 % , the minimum number of participants required per group is 63.||||0.18
72326859|NCT00142792|144177047|SUPERIORITY||||||<|0.001||||||time effect, F(1,109)=87.7, p\<0.001)|Mixed Models Analysis|A random intercept for each participant with a first-order antedependent covariance structure. Adjusted for site.||||||<0.001
72326860|NCT00142792|144177048|SUPERIORITY_OR_OTHER|||||||0.27||||||time by group interaction effect, F(2,373) = 1.3, p =0.27|Mixed Models Analysis|A random intercept for each participant with a first-order antedependent covariance structure. Adjusted for site.||||||0.27
72326861|NCT00142792|144177048|SUPERIORITY||||||<|0.001||||||time effect, F(1,109)=91.1, p\<0.001|Mixed Models Analysis|A random intercept for each participant with a first-order antedependent covariance structure. Adjusted for site.||||||<0.001
72326862|NCT01328743|144177059|SUPERIORITY|||||||0.04|||||||t-test, 2 sided|||||||.04
72326863|NCT01328743|144177060|SUPERIORITY||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||||||<.01
72326864|NCT01328743|144177061|SUPERIORITY||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||||||<.01
72326865|NCT01328743|144177062|SUPERIORITY|||||||0.48|||||||Wilcoxon (Mann-Whitney)|||||||.48
72326866|NCT01328743|144177063|SUPERIORITY|||||||0.25|||||||t-test, 2 sided|||||||.25
72326867|NCT01328743|144177064|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<.001
72326868|NCT02481258|144177065|EQUIVALENCE|Power calculations were based on a two-sample t-test. A priori calculations to detect an effect size of 0.57 units indicated that that 50 patients per arm were needed to have 80% power. The actual effect size observed in the present study was 0.86.||||||0.05|||||||ANCOVA|||The statistical analysis was done using an ANCOVA analysis adjusting for the baseline aortic valve calcium levels.||||0.05
72326869|NCT02481258|144177067|EQUIVALENCE|Power calculations were based on a two-sample t-tests assuming initial recruitment of 50 subjects.|||||>|0.05||||||Our a priori threshold for statistical significance was p \< 0.05.|ANCOVA|||||||>0.05
72326870|NCT02481258|144177068|EQUIVALENCE|Power calculations were based on a two-sample t-test.|||||>|0.05||||||Our a priori threshold for statistical significance was p \< 0.05.|ANCOVA|||The statistical analysis was done using an ANCOVA analysis adjusting for the baseline aortic valve calcium levels.||||>0.05
72326871|NCT01900665|144177071|SUPERIORITY||Mean Difference (Final Values)|-0.8||||0.095|TWO_SIDED|95.0|-1.73|0.14|||Mixed Models Analysis|The Kenward-Roger approximation was used to estimate the denominator degrees of freedom.||||0.14|-1.73|0.095
72326872|NCT01415583|144177100|NON_INFERIORITY|Consistent with the noninferiority design, the null hypothesis states that the bleeding rate in patients receiving perioperative dexamethasone differed from the bleeding rate in patients receiving perioperative placebo; the alternative hypothesis states that the bleeding rate with dexamethasone is not greater than placebo by more than the noninferiority margin.||||||0.05|||||||t-test, 1 sided|||||||0.05
72326873|NCT01415583|144177100|NON_INFERIORITY|This noninferiority margin was set at 5%, meaning a difference in bleeding rates that did not exceed 5% would be taken as evidence that the bleeding with dexamethasone is not greater than that with placebo by more than 5%.||||||0.05|||||||t-test, 1 sided|||||||0.05
72326874|NCT00552071|144177106|OTHER|||||||0.4||||||A two-sided p value of \<0.05 was considered significant.|t-test, 2 sided|||||||0.40
72326875|NCT00552071|144177107|OTHER|||||||0.43||||||A two-sided p value of \<0.05 was considered significant.|t-test, 2 sided|||||||0.43
72326876|NCT01979614|144177108|SUPERIORITY_OR_OTHER||Standard Error|-0.1116||||0.438|TWO_SIDED|95.0|-0.399|0.176|||ANCOVA|||SAP for Global Myocardial Perfusion Reserve Index (MPRI)||0.176|-0.399|0.438
72326877|NCT00756275|144177117|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.33|||<|0.05|TWO_SIDED|95.0|0.91|20.56|||Chi-squared|||||20.56|.91|<0.05
72326878|NCT00756275|144177118|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.59|STANDARD_ERROR_OF_MEAN|2.36||0.5|TWO_SIDED|95.0|-6.29|3.11|||t-test, 2 sided|||||3.11|-6.29|.50
72326879|NCT00756275|144177119|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.9||||0.3|TWO_SIDED|95.0|0.58|14.5|||Fisher Exact|||||14.50|.58|.30
72326880|NCT00756275|144177120|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.98|STANDARD_ERROR_OF_MEAN|8.38||0.34|TWO_SIDED|95.0|-24.64|8.68|||t-test, 2 sided|||||8.68|-24.64|.34
72326881|NCT00756275|144177121|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.39|STANDARD_ERROR_OF_MEAN|8.1||0.36|TWO_SIDED|95.0|-8.73|23.52|||t-test, 2 sided|||||23.52|-8.73|.36
72326882|NCT00756275|144177122|SUPERIORITY_OR_OTHER|||||||0.57|||||||Chi-squared|||||||.57
72326883|NCT00756275|144177123|SUPERIORITY_OR_OTHER|||||||0.31|||||||Chi-squared|||||||.31
72326884|NCT00756275|144177124|SUPERIORITY_OR_OTHER|||||||0.72|||||||Chi-squared|||||||.72
72326885|NCT00756275|144177125|SUPERIORITY_OR_OTHER|||||||0.18|||||||Chi-squared|||||||.18
72326886|NCT00756275|144177126|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.56|STANDARD_ERROR_OF_MEAN|1.72||0.75|TWO_SIDED|95.0|-3.98|2.87|||t-test, 2 sided|||||2.87|-3.98|.75
72326887|NCT00913510|144177162|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|2.0||||1||||||The p-value is calculated to the fourth decimal place.|Wilcoxon (Mann-Whitney)|||"H0 : µt = µc versus H1 : µt ≠ µc µt = Exp. relative change of frequency of micturitions per day in test group µc = Exp. relative change of frequency of micturitions per day in control group.~Plan was to have 44 evaluable subjects (90% power) but power of the study was reduced by early termination. It cannot be concluded that there is no difference between the treatment groups due to insufficient power."||||1.0000
72326888|NCT02383862|144177197|SUPERIORITY||Mean Difference (Final Values)|1.1|STANDARD_ERROR_OF_MEAN|0.79||0.165|TWO_SIDED|95.0|-0.45|2.64|||t-test, 2 sided|||||2.64|-0.45|0.165
72326889|NCT02383862|144177198|SUPERIORITY||Mean Difference (Final Values)|0.84|STANDARD_ERROR_OF_MEAN|1.05||0.425|TWO_SIDED|95.0|-1.23|2.91|||t-test, 2 sided|||||2.91|-1.23|0.425
72326890|NCT02383862|144177199|SUPERIORITY||Mean Difference (Final Values)|0.65|STANDARD_ERROR_OF_MEAN|1.05||0.539|TWO_SIDED|95.0|-1.41|2.7|||t-test, 2 sided|||||2.70|-1.41|0.539
72326891|NCT02383862|144177200|SUPERIORITY||Mean Difference (Final Values)|0.83|STANDARD_ERROR_OF_MEAN|1.16||0.471|TWO_SIDED|95.0|-1.44|3.11|||t-test, 2 sided|||||3.11|-1.44|0.471
72612668|NCT00855582|144754207|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9|STANDARD_ERROR_OF_MEAN|0.26|<|0.001||95.0||||Statistical significance was assessed using a Dunnett-Bonferroni gatekeeping procedure for multiple hypothesis testing. The pre-specified alpha level of 0.0228 was used.|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.||||||<0.001
72612669|NCT00855582|144754208|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.5|STANDARD_ERROR_OF_MEAN|2.85|<|0.001||95.0||||Statistical significance was assessed using a Dunnett-Bonferroni gatekeeping procedure for multiple hypothesis testing. Based on the results of prior tests under this procedure, the statistical significance of this hypothesis was not assessed.|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.||||||<0.001
72612670|NCT00855582|144754209|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.26||0.156||95.0||||Statistical significance was assessed using a Dunnett-Bonferroni gatekeeping procedure for multiple hypothesis testing. Based on the results of prior tests under this procedure, the statistical significance of this hypothesis was not assessed.|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.||||||0.156
72612671|NCT00855582|144754210|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.51||0.226||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons.|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.||||||0.226
72612672|NCT00855582|144754210|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.8|STANDARD_ERROR_OF_MEAN|0.5|<|0.001||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons.|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.||||||<0.001
72612673|NCT00855582|144754211|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8|STANDARD_ERROR_OF_MEAN|0.53||0.121||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons. P-value is for change from Baseline at Week 4. Change= Week 4 minus Baseline|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.||||||0.121
72612674|NCT00855582|144754211|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8|STANDARD_ERROR_OF_MEAN|0.57||0.169||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons. P-value is for change from Baseline at Week 8. Change= Week 8 minus Baseline|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.||||||0.169
72612675|NCT00855582|144754211|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.9|STANDARD_ERROR_OF_MEAN|0.52|<|0.001||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons. P-value is for change from Baseline at Week 4. Change= Week 4 minus Baseline|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.||||||<0.001
72612676|NCT00855582|144754211|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.1|STANDARD_ERROR_OF_MEAN|0.56|<|0.001||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons. P-value is for change from Baseline at Week 8. Change= Week 8 minus Baseline|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.||||||<0.001
72612677|NCT00855582|144754212|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.1|STANDARD_ERROR_OF_MEAN|0.6|<|0.001||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons. P-value is for change from Baseline at Week 4. Change= Week 4 minus Baseline|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.||||||<0.001
72612678|NCT00855582|144754212|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.1|STANDARD_ERROR_OF_MEAN|0.71|<|0.001||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons. P-value is for change from Baseline at Week 8. Change= Week 8 minus Baseline|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.||||||<0.001
72612679|NCT00855582|144754212|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.0|STANDARD_ERROR_OF_MEAN|0.59|<|0.001||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons. P-value is for change from Baseline at Week 4. Change= Week 4 minus Baseline|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.||||||<0.001
72612680|NCT00855582|144754212|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.8|STANDARD_ERROR_OF_MEAN|0.71|<|0.001||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons. P-value is for change from Baseline at Week 8. Change= Week 8 minus Baseline|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.||||||<0.001
72612681|NCT00855582|144754213|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.1|STANDARD_ERROR_OF_MEAN|3.1|<|0.001||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons. P-value is for change from Baseline at Week 4. Change= Week 4 minus Baseline|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.||||||<0.001
72326892|NCT02383862|144177201|SUPERIORITY||Mean Difference (Final Values)|1.49|STANDARD_ERROR_OF_MEAN|1.1||0.174|TWO_SIDED|95.0|-0.66|3.65|||t-test, 2 sided|||||3.65|-0.66|0.174
72326893|NCT02383862|144177202|SUPERIORITY||Mean Difference (Final Values)|1.67|STANDARD_ERROR_OF_MEAN|1.36||0.222|TWO_SIDED|95.0|-1.0|4.35|||t-test, 2 sided|||||4.35|-1.00|0.222
72326894|NCT01718522|144177244|OTHER|||||||0.001|||||||t-test, 2 sided|||||||0.001
72612682|NCT00855582|144754213|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.0|STANDARD_ERROR_OF_MEAN|3.0|<|0.001||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons. P-value is for change from Baseline at Week 8. Change= Week 8 minus Baseline|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.||||||<0.001
72612683|NCT00855582|144754213|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|24.5|STANDARD_ERROR_OF_MEAN|3.1|<|0.001||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons. P-value is for change from Baseline at Week 4. Change= Week 4 minus Baseline|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.||||||<0.001
72612684|NCT00855582|144754213|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|20.9|STANDARD_ERROR_OF_MEAN|2.9|<|0.001||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons. P-value is for change from Baseline at Week 8. Change= Week 8 minus Baseline|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.||||||<0.001
72612685|NCT00855582|144754214|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.22||0.215||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons. P-value is for change from Baseline at Week 4. Change= Week 4 minus Baseline|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.||||||0.215
72612686|NCT00855582|144754214|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.24||0.325||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons. P-value is for change from Baseline at Week 8. Change= Week 8 minus Baseline|ANOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.||||||0.325
72612687|NCT00855582|144754214|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9|STANDARD_ERROR_OF_MEAN|0.22|<|0.001||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons. P-value is for change from Baseline at Week 4. Change= Week 4 minus Baseline|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.||||||<0.001
72612688|NCT00855582|144754214|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.23||0.011||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons. P-value is for change from Baseline at Week 8. Change= Week 8 minus Baseline|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.||||||0.011
72612689|NCT00855582|144754215|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|0.38||0.23||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons.|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.||||||0.230
72612690|NCT00855582|144754215|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.4|STANDARD_ERROR_OF_MEAN|0.37|<|0.001||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons.|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.||||||<0.001
72612691|NCT00855582|144754216|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.3||0.191||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons.|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.||||||0.191
72612692|NCT00855582|144754216|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9|STANDARD_ERROR_OF_MEAN|0.3|<|0.001||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons.|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.||||||<0.001
72326895|NCT01718522|144177245|OTHER|||||||0.12|||||||Wilcoxon Signed-Rank Test|||||||0.12
72326896|NCT01718522|144177246|OTHER|||||||0.3|||||||Wilcoxon Signed-Rank Test|||||||0.30
72326897|NCT01718522|144177247|OTHER|||||||0.03|||||||t-test, 2 sided|||||||0.03
72326898|NCT01718522|144177248|OTHER|||||||0.04|||||||Wilcoxon Signed-Rank Test|||||||0.04
72326899|NCT01718522|144177249|OTHER|||||||0.35|||||||Wilcoxon Signed-Rank Test|||||||0.35
72612693|NCT00855582|144754217|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.1||0.763||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons.|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.||||||0.763
72612694|NCT00855582|144754217|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.1||0.075||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons.|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.||||||0.075
72612695|NCT00855582|144754218|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.1||0.384||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons.|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.||||||0.384
72612696|NCT00855582|144754218|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.1||0.082||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons.|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.||||||0.082
72326900|NCT01718522|144177250|OTHER|||||||0.001|||||||Wilcoxon Signed-Rank Test|||||||0.001
72326901|NCT01718522|144177251|OTHER|||||||0.61|||||||Wilcoxon Signed-Rank Test|||||||0.61
72326902|NCT01718522|144177252|OTHER|||||||0.1|||||||Wilcoxon Signed-Rank Test|||||||0.1
72612697|NCT00855582|144754219|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.3|STANDARD_ERROR_OF_MEAN|0.2|<|0.001||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons.|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.||||||<0.001
72612698|NCT00855582|144754219|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.9|STANDARD_ERROR_OF_MEAN|0.2|<|0.001||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons.|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.||||||<0.001
72612699|NCT00855582|144754220|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.5|STANDARD_ERROR_OF_MEAN|0.3|<|0.001||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons.|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.||||||<0.001
72326903|NCT01718522|144177253|OTHER|||||||0.22|||||||Wilcoxon Signed-Rank Test|||||||0.22
72326904|NCT01664247|144177258|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.34|||<|0.0001|TWO_SIDED|95.0|-2.67|-2.01|||ANOVA||The treatment contrast estimated was IDeg - Placebo.|The pre-breakfast measures of SMPG values after 26 weeks of treatment were analysed an ANOVA method with treatment, region and sex as fixed effects, and age and baseline response as covariates.||-2.01|-2.67|<.0001
72612700|NCT00855582|144754220|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.9|STANDARD_ERROR_OF_MEAN|0.3|<|0.001||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons.|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.||||||<0.001
72612701|NCT00855582|144754221|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.7|STANDARD_ERROR_OF_MEAN|0.1|<|0.001||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons.|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.||||||<0.001
72612702|NCT00855582|144754221|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.9|STANDARD_ERROR_OF_MEAN|0.1|<|0.001||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons.|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.||||||<0.001
72612703|NCT00855582|144754222|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.5|STANDARD_ERROR_OF_MEAN|0.1|<|0.001||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons.|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.||||||<0.001
72612704|NCT00855582|144754222|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.9|STANDARD_ERROR_OF_MEAN|0.1|<|0.001||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons.|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.||||||<0.001
72612705|NCT00855582|144754223|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.1|STANDARD_ERROR_OF_MEAN|2.4|<|0.001||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons.|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.||||||<0.001
72612706|NCT00855582|144754223|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|15.8|STANDARD_ERROR_OF_MEAN|2.4|<|0.001||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons.|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.||||||<0.001
72612707|NCT00855582|144754224|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.9|STANDARD_ERROR_OF_MEAN|3.6|<|0.001||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons.|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.||||||<0.001
72612708|NCT00855582|144754224|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|29.7|STANDARD_ERROR_OF_MEAN|3.6|<|0.001||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons.|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.||||||<0.001
72612709|NCT00855582|144754225|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.8|STANDARD_ERROR_OF_MEAN|3.6|<|0.001||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons.|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.||||||<0.001
72612710|NCT00855582|144754225|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|28.4|STANDARD_ERROR_OF_MEAN|3.6|<|0.001||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons.|ANOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.||||||<0.001
72612711|NCT00855582|144754226|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was adjusted for baseline LUTS severity.||||||<0.001
72612712|NCT00855582|144754226|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was adjusted for baseline LUTS severity.||||||<0.001
72612713|NCT00855582|144754227|SUPERIORITY_OR_OTHER|||||||0.006||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was adjusted for baseline LUTS severity.||||||0.006
72612714|NCT00855582|144754227|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was adjusted for baseline LUTS severity.||||||<0.001
72612715|NCT00855582|144754228|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons. P-value is for Question 1.|Regression, Logistic|Logistic regression model includes terms for treatment group, region and centered-baseline IIEF EF Domain score.||||||<0.001
72612716|NCT00855582|144754228|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons. P-value is for Question 2.|Regression, Logistic|Logistic regression model includes terms for treatment group, region and centered-baseline IIEF EF Domain score.||||||<0.001
72612717|NCT00855582|144754228|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons. P-value is for Question 1.|Regression, Logistic|Logistic regression model includes terms for treatment group, region and centered-baseline IIEF EF Domain score.||||||<0.001
72612718|NCT00855582|144754228|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons. P-value is for Question 2.|Regression, Logistic|Logistic regression model includes terms for treatment group, region and centered-baseline IIEF EF Domain score.||||||<0.001
72612719|NCT00855582|144754229|SUPERIORITY_OR_OTHER|||||||0.027||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons.|Ranked ANOVA|||||||0.027
72419426|NCT01194570|144349321|SUPERIORITY_OR_OTHER_LEGACY||Relative Reduction (%)|29.337||||0.0404|TWO_SIDED|95.0|-1.618|51.456||P-value from a ranked ANCOVA on Percent Change from BL adjusting for rank of BL 25-Foot Timed Walk (25-FTW), Geographical Region (US vs ROW) and Age (\<=45, \> 45 years); missing observations imputed with LOCF.|Ranked ANCOVA||Relative reduction was calculated as -Relative change = - (Ocrelizumab response-Placebo response)/Placebo response\*100%. The 95% CI for relative reduction was obtained using the Bootstrap method.|Estimates (back-transformed) based on mixed-effect model of repeated measures (MMRM) using unstructured covariance matrix: log(Post-baseline(BL)/BL) = log(BL 25-FTW) + Geographical Region (US vs. ROW) + Age (\<=45, \> 45 years) + Week + Treatment + Treatment\*Week (repeated values over Week) + log (BL 25-FTW)\*Week. Relative reduction was calculated as -Relative change = -(OCR response-Placebo response)/Placebo response\*100%. The 95% CI for relative reduction was obtained using the Bootstrap method.||51.456|-1.618|0.0404
72612720|NCT00855582|144754229|SUPERIORITY_OR_OTHER|||||||0.186||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons.|Ranked ANOVA|||||||0.186
72612721|NCT03345004|144754232|SUPERIORITY||Estimated ratio|1.091|||=|0.5009|TWO_SIDED|95.0|0.845|1.408|||Mixed Models Analysis|||||1.408|0.845|= 0.5009
72612722|NCT03345004|144754232|SUPERIORITY||Estimated ratio|1.557|||=|0.0078|TWO_SIDED|95.0|1.126|2.153|||Mixed Models Analysis|||||2.153|1.126|= 0.0078
72612723|NCT01013753|144754253|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.14|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001||95.0|0.097|0.182|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2 mcg qd minus Placebo|||0.182|0.097|<0.0001
72612724|NCT01013753|144754253|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.182|STANDARD_ERROR_OF_MEAN|0.021|<|0.0001||95.0|0.14|0.224|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo|||0.224|0.140|<0.0001
72612725|NCT01013753|144754253|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.205|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001||95.0|0.163|0.248|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo|||0.248|0.163|<0.0001
72612726|NCT01013753|144754253|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.229|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001||95.0|0.186|0.272|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 20 mcg qd minus Placebo|||0.272|0.186|<0.0001
72612727|NCT01013753|144754253|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.169|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001||95.0|0.126|0.211|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Form 12 mcg bid minus Placebo|||0.211|0.126|<0.0001
72612728|NCT01013753|144754254|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.163|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001||95.0|0.116|0.211|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2 mcg qd minus Placebo|||0.211|0.116|<0.0001
72612729|NCT01013753|144754254|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.212|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001||95.0|0.166|0.259|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo|||0.259|0.166|<0.0001
72612730|NCT01013753|144754254|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.233|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001||95.0|0.186|0.28|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo|||0.280|0.186|<0.0001
72612731|NCT01013753|144754254|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.25|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001||95.0|0.203|0.298|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 20 mcg qd minus Placebo|||0.298|0.203|<0.0001
72612732|NCT01013753|144754254|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.184|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001||95.0|0.137|0.231|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Form 12 mcg bid minus Placebo|||0.231|0.137|<0.0001
72612733|NCT01013753|144754255|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.115|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001||95.0|0.073|0.158|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2 mcg qd minus Placebo|||0.158|0.073|<0.0001
72612734|NCT01013753|144754255|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.151|STANDARD_ERROR_OF_MEAN|0.021|<|0.0001||95.0|0.11|0.193|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo|||0.193|0.110|<0.0001
72612735|NCT01013753|144754255|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.177|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001||95.0|0.135|0.219|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo|||0.219|0.135|<0.0001
72612736|NCT01013753|144754255|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.207|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001||95.0|0.164|0.25|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 20 mcg qd minus Placebo|||0.250|0.164|<0.0001
72612737|NCT01013753|144754255|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.152|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001||95.0|0.11|0.194|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Form 12 mcg bid minus Placebo|||0.194|0.110|<0.0001
72612738|NCT01013753|144754256|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.102|STANDARD_ERROR_OF_MEAN|0.023|<|0.0001||95.0|0.056|0.148|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2 mcg qd minus Placebo|||0.148|0.056|<0.0001
72612739|NCT01013753|144754256|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.135|STANDARD_ERROR_OF_MEAN|0.023|<|0.0001||95.0|0.09|0.18|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo|||0.180|0.090|<0.0001
72612740|NCT01013753|144754256|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.161|STANDARD_ERROR_OF_MEAN|0.023|<|0.0001||95.0|0.116|0.207|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo|||0.207|0.116|<0.0001
72612741|NCT01013753|144754256|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.18|STANDARD_ERROR_OF_MEAN|0.023|<|0.0001||95.0|0.134|0.226|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 20 mcg qd minus Placebo|||0.226|0.134|<0.0001
72612742|NCT01013753|144754256|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.166|STANDARD_ERROR_OF_MEAN|0.023|<|0.0001||95.0|0.12|0.211|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Form 12 mcg bid minus Placebo|||0.211|0.120|<0.0001
72612743|NCT01013753|144754257|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.103|STANDARD_ERROR_OF_MEAN|0.023|<|0.0001||95.0|0.058|0.148|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2 mcg qd minus Placebo|||0.148|0.058|<0.0001
72612744|NCT01013753|144754257|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.133|STANDARD_ERROR_OF_MEAN|0.023|<|0.0001||95.0|0.088|0.177|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo|||0.177|0.088|<0.0001
72612745|NCT01013753|144754257|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.169|STANDARD_ERROR_OF_MEAN|0.023|<|0.0001||95.0|0.124|0.214|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo|||0.214|0.124|<0.0001
72612746|NCT01013753|144754257|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.199|STANDARD_ERROR_OF_MEAN|0.023|<|0.0001||95.0|0.153|0.244|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 20 mcg qd minus Placebo|||0.244|0.153|<0.0001
72612747|NCT01013753|144754257|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.103|STANDARD_ERROR_OF_MEAN|0.023|<|0.0001||95.0|0.058|0.147|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Form 12 mcg bid minus Placebo|||0.147|0.058|<0.0001
72612748|NCT01013753|144754258|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.103|STANDARD_ERROR_OF_MEAN|0.026|<|0.0001||95.0|0.052|0.154|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2 mcg qd minus Placebo|||0.154|0.052|<0.0001
72612749|NCT01013753|144754258|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.156|STANDARD_ERROR_OF_MEAN|0.026|<|0.0001||95.0|0.106|0.207|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo|||0.207|0.106|<0.0001
72612750|NCT01013753|144754258|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.141|STANDARD_ERROR_OF_MEAN|0.026|<|0.0001||95.0|0.091|0.192|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo|||0.192|0.091|<0.0001
72612751|NCT01013753|144754258|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.169|STANDARD_ERROR_OF_MEAN|0.026|<|0.0001||95.0|0.118|0.221|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 20 mcg qd minus Placebo|||0.221|0.118|<0.0001
72612752|NCT01013753|144754258|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.102|STANDARD_ERROR_OF_MEAN|0.026|<|0.0001||95.0|0.051|0.153|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Form 12 mcg bid minus Placebo|||0.153|0.051|<0.0001
72612753|NCT01013753|144754259|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.061|STANDARD_ERROR_OF_MEAN|0.024||0.0107||95.0|0.014|0.107|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2 mcg qd minus Placebo|||0.107|0.014|0.0107
72612754|NCT01013753|144754259|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.115|STANDARD_ERROR_OF_MEAN|0.023|<|0.0001||95.0|0.069|0.16|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo|||0.160|0.069|<0.0001
72612755|NCT01013753|144754259|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.115|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001||95.0|0.069|0.161|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo|||0.161|0.069|<0.0001
72612756|NCT01013753|144754259|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.144|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001||95.0|0.098|0.191|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 20 mcg qd minus Placebo|||0.191|0.098|<0.0001
72612757|NCT01013753|144754259|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.091|STANDARD_ERROR_OF_MEAN|0.024||0.0001||95.0|0.044|0.137|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Form 12 mcg bid minus Placebo|||0.137|0.044|0.0001
72612758|NCT01013753|144754260|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.082|STANDARD_ERROR_OF_MEAN|0.023||0.0005||95.0|0.036|0.128|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2 mcg qd minus Placebo|||0.128|0.036|0.0005
72612759|NCT01013753|144754260|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.136|STANDARD_ERROR_OF_MEAN|0.023|<|0.0001||95.0|0.09|0.181|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo|||0.181|0.090|<0.0001
72612760|NCT01013753|144754260|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.128|STANDARD_ERROR_OF_MEAN|0.023|<|0.0001||95.0|0.083|0.174|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo|||0.174|0.083|<0.0001
72612761|NCT01013753|144754260|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.157|STANDARD_ERROR_OF_MEAN|0.023|<|0.0001||95.0|0.111|0.203|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 20 mcg qd minus Placebo|||0.203|0.111|<0.0001
72612762|NCT01013753|144754260|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.097|STANDARD_ERROR_OF_MEAN|0.023|<|0.0001||95.0|0.051|0.143|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Form 12 mcg bid minus Placebo|||0.143|0.051|<0.0001
72612763|NCT01013753|144754261|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.048|STANDARD_ERROR_OF_MEAN|0.028||0.0952||95.0|-0.008|0.103|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2 mcg qd minus Placebo|||0.103|-0.008|0.0952
72612764|NCT01013753|144754261|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.103|STANDARD_ERROR_OF_MEAN|0.028||0.0003||95.0|0.048|0.158|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo|||0.158|0.048|0.0003
72612765|NCT01013753|144754261|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.089|STANDARD_ERROR_OF_MEAN|0.028||0.0016||95.0|0.034|0.145|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo|||0.145|0.034|0.0016
72612766|NCT01013753|144754261|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.127|STANDARD_ERROR_OF_MEAN|0.028|<|0.0001||95.0|0.071|0.183|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 20 mcg qd minus Placebo|||0.183|0.071|<0.0001
72612767|NCT01013753|144754261|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.073|STANDARD_ERROR_OF_MEAN|0.028||0.0096||95.0|0.018|0.129|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Form 12 mcg bid minus Placebo|||0.129|0.018|0.0096
72612768|NCT01013753|144754262|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.037|STANDARD_ERROR_OF_MEAN|0.026||0.147||95.0|-0.013|0.088|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2 mcg qd minus Placebo|||0.088|-0.013|0.1470
72612769|NCT01013753|144754262|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.091|STANDARD_ERROR_OF_MEAN|0.025||0.0003||95.0|0.042|0.141|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo|||0.141|0.042|0.0003
72612770|NCT01013753|144754262|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.11|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001||95.0|0.06|0.16|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo|||0.160|0.060|<0.0001
72612771|NCT01013753|144754262|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.129|STANDARD_ERROR_OF_MEAN|0.026|<|0.0001||95.0|0.078|0.179|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 20 mcg qd minus Placebo|||0.179|0.078|<0.0001
72612772|NCT01013753|144754262|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.051|STANDARD_ERROR_OF_MEAN|0.025||0.0448||95.0|0.001|0.101|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Form 12 mcg bid minus Placebo|||0.101|0.001|0.0448
72612773|NCT01013753|144754263|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.408|STANDARD_ERROR_OF_MEAN|0.067|<|0.0001||95.0|0.277|0.539|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2 mcg qd minus Placebo|||0.539|0.277|<0.0001
72612774|NCT01013753|144754263|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.566|STANDARD_ERROR_OF_MEAN|0.066|<|0.0001||95.0|0.438|0.695|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo|||0.695|0.438|<0.0001
72612775|NCT01013753|144754263|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.612|STANDARD_ERROR_OF_MEAN|0.066|<|0.0001||95.0|0.482|0.743|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo|||0.743|0.482|<0.0001
72326905|NCT01664247|144177259|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.69|||<|0.0001|TWO_SIDED|95.0|-3.04|-2.34|||Mixed Models Analysis||The treatment contrast estimated was IDeg - Placebo|The 8-point profile (SMPG) values after 26 weeks of treatment were analysed jointly using a linear mixed model with an un-structured residual covariance structure and with treatment, time-point and an interaction between treatment and time-point, region and sex as fixed effects, and age and baseline response per time-point as covariates. Missing data was imputed using LOCF. The treatment contrast estimated was IDeg - Placebo for the time point before breakfast.||-2.34|-3.04|<.0001
72326906|NCT01664247|144177259|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.09|||<|0.0001|TWO_SIDED|95.0|-2.71|-1.48|||Mixed Models Analysis||The treatment contrast estimated was IDeg - Placebo.|The 8-point profile (SMPG) values after 26 weeks of treatment were analysed jointly using a linear mixed model with an un-structured residual covariance structure and with treatment, time-point and an interaction between treatment and time-point, region and sex as fixed effects, and age and baseline response per time-point as covariates. Missing data was imputed using LOCF. The treatment contrast estimated was IDeg - Placebo for the time point 90 mins after breakfast.||-1.48|-2.71|<.0001
72326907|NCT01664247|144177259|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.01|||<|0.0001|TWO_SIDED|95.0|-2.47|-1.56|||Mixed Models Analysis||The treatment contrast estimated was IDeg - Placebo.|The 8-point profile (SMPG) values after 26 weeks of treatment were analysed jointly using a linear mixed model with an un-structured residual covariance structure and with treatment, time-point and an interaction between treatment and time-point, region and sex as fixed effects, and age and baseline response per time-point as covariates. Missing data was imputed using LOCF. The treatment contrast estimated was IDeg - Placebo for the time point before lunch.||-1.56|-2.47|<.0001
72326908|NCT01664247|144177259|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-1.93|||<|0.0001|TWO_SIDED|95.0|-2.46|-1.4|||Mixed Models Analysis||The treatment contrast estimated was IDeg - Placebo.|The 8-point profile (SMPG) values after 26 weeks of treatment were analysed jointly using a linear mixed model with an un-structured residual covariance structure and with treatment, time-point and an interaction between treatment and time-point, region and sex as fixed effects, and age and baseline response per time-point as covariates. Missing data was imputed using LOCF. The treatment contrast estimated was IDeg - Placebo for the time point 90 mins after start of lunch.||-1.40|-2.46|<.0001
72612776|NCT01013753|144754263|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.67|STANDARD_ERROR_OF_MEAN|0.067|<|0.0001||95.0|0.539|0.801|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 20 mcg qd minus Placebo|||0.801|0.539|<0.0001
72612777|NCT01013753|144754263|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.588|STANDARD_ERROR_OF_MEAN|0.066|<|0.0001||95.0|0.457|0.718|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Form 12 mcg bid minus Placebo|||0.718|0.457|<0.0001
72326909|NCT01664247|144177259|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.74|||<|0.0001|TWO_SIDED|95.0|-2.25|-1.23|||Mixed Models Analysis||The treatment contrast estimated was IDeg - Placebo.|The 8-point profile (SMPG) values after 26 weeks of treatment were analysed jointly using a linear mixed model with an un-structured residual covariance structure and with treatment, time-point and an interaction between treatment and time-point, region and sex as fixed effects, and age and baseline response per time-point as covariates. Missing data was imputed using LOCF. The treatment contrast estimated was IDeg - Placebo for the time point main evening meal.||-1.23|-2.25|<.0001
72326910|NCT01664247|144177259|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.72|||<|0.0001|TWO_SIDED|95.0|-2.26|-1.18|||Mixed Models Analysis||The treatment contrast estimated was IDeg - Placebo.|The 8-point profile (SMPG) values after 26 weeks of treatment were analysed jointly using a linear mixed model with an un-structured residual covariance structure and with treatment, time-point and an interaction between treatment and time-point, region and sex as fixed effects, and age and baseline response per time-point as covariates. Missing data was imputed using LOCF. The treatment contrast estimated was IDeg - Placebo for the time point 90 mins after main evening meal.||-1.18|-2.26|<.0001
72326911|NCT01664247|144177259|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.75|||<|0.0001|TWO_SIDED|95.0|-2.27|-1.23|||Mixed Models Analysis||The treatment contrast estimated was IDeg - Placebo.|The 8-point profile (SMPG) values after 26 weeks of treatment were analysed jointly using a linear mixed model with an un-structured residual covariance structure and with treatment, time-point and an interaction between treatment and time-point, region and sex as fixed effects, and age and baseline response per time-point as covariates. Missing data was imputed using LOCF. The treatment contrast estimated was IDeg - Placebo for the time point before bedtime.||-1.23|-2.27|<.0001
72419427|NCT01194570|144349322|SUPERIORITY_OR_OTHER_LEGACY||Ratio of Adjusted Geometric Means|0.9|||<|0.0001|TWO_SIDED|95.0|0.876|0.924||P-value is from ranked ANCOVA on Percent Change from BL adjusting for rank of BL T2 lesion volume, Geographical Region (US vs ROW) and Age (\<=45, \> 45 years); missing observations imputed with LOCF.|Ranked ANCOVA|||Estimates (back-transformed) are based on mixed-effect model of repeated measures (MMRM) using unstructured covariance matrix: log(Post-BL/BL) = log(BL T2 lesion volume) + Geographical Region (US vs. ROW) + Age (\<=45, \> 45 years) + Week + Treatment + Treatment\*Week (repeated values over Week) + log (BL T2 lesion volume)\*Week.||0.924|0.876|< 0.0001
72419428|NCT01194570|144349323|SUPERIORITY_OR_OTHER_LEGACY||Relative Reduction (%)|17.475||||0.0206|TWO_SIDED|95.0|3.206|29.251|||MMRM||Relative reduction was calculated as -Relative change = - (Ocrelizumab response-Placebo response)/Placebo response\*100%. The 95% CI for relative reduction was obtained using the Bootstrap method.|Estimates are from analysis based on MMRM using unstructured covariance matrix: Percentage Change = Brain Volume at Week 24 + Geographical Region (US vs. ROW) + Age (\<=45, \> 45 years) + Week + Treatment + Treatment\*Week (repeated values over Week) + Brain Volume at Week 24\*Week. Relative reduction was calculated as - Relative change = - (OCR response-Placebo response)/Placebo response\*100%. The 95% CI for relative reduction was obtained using Bootstrap method.||29.251|3.206|0.0206
72612778|NCT01013753|144754264|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.337|STANDARD_ERROR_OF_MEAN|0.063|<|0.0001||95.0|0.213|0.461|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2 mcg qd minus Placebo|||0.461|0.213|<0.0001
72612779|NCT01013753|144754264|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.485|STANDARD_ERROR_OF_MEAN|0.062|<|0.0001||95.0|0.363|0.606|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo|||0.606|0.363|<0.0001
72612780|NCT01013753|144754264|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.531|STANDARD_ERROR_OF_MEAN|0.063|<|0.0001||95.0|0.408|0.655|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo|||0.655|0.408|<0.0001
72612781|NCT01013753|144754264|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.648|STANDARD_ERROR_OF_MEAN|0.063|<|0.0001||95.0|0.524|0.772|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 20 mcg qd minus Placebo|||0.772|0.524|<0.0001
72612782|NCT01013753|144754264|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.551|STANDARD_ERROR_OF_MEAN|0.063|<|0.0001||95.0|0.428|0.674|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Form 12 mcg bid minus Placebo|||0.674|0.428|<0.0001
72612783|NCT01013753|144754265|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.373|STANDARD_ERROR_OF_MEAN|0.061|<|0.0001||95.0|0.253|0.493|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2 mcg qd minus Placebo|||0.493|0.253|<0.0001
72612784|NCT01013753|144754265|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.527|STANDARD_ERROR_OF_MEAN|0.06|<|0.0001||95.0|0.409|0.645|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo|||0.645|0.409|<0.0001
72612785|NCT01013753|144754265|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.572|STANDARD_ERROR_OF_MEAN|0.061|<|0.0001||95.0|0.453|0.692|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo|||0.692|0.453|<0.0001
72612786|NCT01013753|144754265|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.66|STANDARD_ERROR_OF_MEAN|0.061|<|0.0001||95.0|0.54|0.781|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 20 mcg qd minus Placebo|||0.781|0.540|<0.0001
72612787|NCT01013753|144754265|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.57|STANDARD_ERROR_OF_MEAN|0.061|<|0.0001||95.0|0.451|0.689|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Form 12 mcg bid minus Placebo|||0.689|0.451|<0.0001
72612788|NCT01013753|144754266|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.302|STANDARD_ERROR_OF_MEAN|0.068|<|0.0001||95.0|0.168|0.436|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2 mcg qd minus Placebo|||0.436|0.168|<0.0001
72612789|NCT01013753|144754266|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.429|STANDARD_ERROR_OF_MEAN|0.067|<|0.0001||95.0|0.297|0.561|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo|||0.561|0.297|<0.0001
72612790|NCT01013753|144754266|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.466|STANDARD_ERROR_OF_MEAN|0.068|<|0.0001||95.0|0.333|0.599|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo|||0.599|0.333|<0.0001
72612791|NCT01013753|144754266|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.534|STANDARD_ERROR_OF_MEAN|0.068|<|0.0001||95.0|0.4|0.669|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 20 mcg qd minus Placebo|||0.669|0.400|<0.0001
72612792|NCT01013753|144754266|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.504|STANDARD_ERROR_OF_MEAN|0.068|<|0.0001||95.0|0.371|0.637|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Form 12 mcg bid minus Placebo|||0.637|0.371|<0.0001
72612793|NCT01013753|144754267|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.264|STANDARD_ERROR_OF_MEAN|0.07||0.0002||95.0|0.127|0.401|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2 mcg qd minus Placebo|||0.401|0.127|0.0002
72612794|NCT01013753|144754267|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.468|STANDARD_ERROR_OF_MEAN|0.069|<|0.0001||95.0|0.333|0.602|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo|||0.602|0.333|<0.0001
72612795|NCT01013753|144754267|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.484|STANDARD_ERROR_OF_MEAN|0.069|<|0.0001||95.0|0.348|0.62|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo|||0.620|0.348|<0.0001
72612796|NCT01013753|144754267|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.624|STANDARD_ERROR_OF_MEAN|0.07|<|0.0001||95.0|0.487|0.761|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 20 mcg qd minus Placebo|||0.761|0.487|<0.0001
72612797|NCT01013753|144754267|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.447|STANDARD_ERROR_OF_MEAN|0.069|<|0.0001||95.0|0.311|0.583|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Form 12 mcg bid minus Placebo|||0.583|0.311|<0.0001
72612798|NCT01013753|144754268|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|22.012|STANDARD_ERROR_OF_MEAN|3.671|<|0.0001||95.0|14.802|29.223|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2 mcg qd minus Placebo|||29.223|14.802|<0.0001
72612799|NCT01013753|144754268|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|29.022|STANDARD_ERROR_OF_MEAN|3.61|<|0.0001||95.0|21.931|36.114|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo|||36.114|21.931|<0.0001
72612800|NCT01013753|144754268|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|27.887|STANDARD_ERROR_OF_MEAN|3.631|<|0.0001||95.0|20.755|35.019|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo|||35.019|20.755|<0.0001
72612801|NCT01013753|144754268|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|32.935|STANDARD_ERROR_OF_MEAN|3.668|<|0.0001||95.0|25.73|40.139|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 20 mcg qd minus Placebo|||40.139|25.730|<0.0001
72612802|NCT01013753|144754268|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|23.528|STANDARD_ERROR_OF_MEAN|3.644|<|0.0001||95.0|16.371|30.686|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Form 12 mcg bid minus Placebo|||30.686|16.371|<0.0001
72612803|NCT01013753|144754269|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.92|STANDARD_ERROR_OF_MEAN|3.64|<|0.0001||95.0|7.77|22.071|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2 mcg qd minus Placebo|||22.071|7.770|<0.0001
72612804|NCT01013753|144754269|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|24.834|STANDARD_ERROR_OF_MEAN|3.58|<|0.0001||95.0|17.801|31.866|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo|||31.866|17.801|<0.0001
72612805|NCT01013753|144754269|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|23.613|STANDARD_ERROR_OF_MEAN|3.601|<|0.0001||95.0|16.539|30.686|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo|||30.686|16.539|<0.0001
72612806|NCT01013753|144754269|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|28.449|STANDARD_ERROR_OF_MEAN|3.637|<|0.0001||95.0|21.305|35.594|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 20 mcg qd minus Placebo|||35.594|21.305|<0.0001
72612807|NCT01013753|144754269|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|20.439|STANDARD_ERROR_OF_MEAN|3.614|<|0.0001||95.0|13.341|27.538|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Form 12 mcg bid minus Placebo|||27.538|13.341|<0.0001
72612808|NCT01013753|144754270|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.994|STANDARD_ERROR_OF_MEAN|0.507|<|0.0001||95.0|-2.989|-0.999|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2 mcg qd minus Placebo|||-0.999|-2.989|<0.0001
72612809|NCT01013753|144754270|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.095|STANDARD_ERROR_OF_MEAN|0.498|<|0.0001||95.0|-3.073|-1.116|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo|||-1.116|-3.073|<0.0001
72612810|NCT01013753|144754270|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.836|STANDARD_ERROR_OF_MEAN|0.503||0.0003||95.0|-2.824|-0.849|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo|||-0.849|-2.824|0.0003
72612811|NCT01013753|144754270|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.789|STANDARD_ERROR_OF_MEAN|0.506||0.0004||95.0|-2.783|-0.795|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 20 mcg qd minus Placebo|||-0.795|-2.783|0.0004
72612812|NCT01013753|144754270|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.27|STANDARD_ERROR_OF_MEAN|0.503||0.0118||95.0|-2.258|-0.283|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Form 12 mcg bid minus Placebo|||-0.283|-2.258|0.0118
72612813|NCT01013753|144754271|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.093|STANDARD_ERROR_OF_MEAN|0.025||0.0002||95.0|0.045|0.141|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2 mcg qd minus Placebo|||0.141|0.045|0.0002
72326912|NCT01664247|144177259|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.5|||<|0.0001|TWO_SIDED|95.0|-2.91|-2.09|||Mixed Models Analysis||The treatment contrast estimated was IDeg - Placebo.|The 8-point profile (SMPG) values after 26 weeks of treatment were analysed jointly using a linear mixed model with an un-structured residual covariance structure and with treatment, time-point and an interaction between treatment and time-point, region and sex as fixed effects, and age and baseline response per time-point as covariates. Missing data was imputed using LOCF. The treatment contrast estimated was IDeg - Placebo for the time point before breakfast the following day.||-2.09|-2.91|<.0001
72326913|NCT00003869|144177295|SUPERIORITY_OR_OTHER|||||||0.54||95.0|||||Log Rank|||||||0.54
72326914|NCT00003869|144177296|SUPERIORITY_OR_OTHER|||||||0.18||95.0|||||Fisher Exact|||||||0.18
72326915|NCT00003869|144177297|SUPERIORITY_OR_OTHER|||||||0.5||95.0|||||Log Rank|||||||0.50
72326916|NCT00003869|144177298|SUPERIORITY_OR_OTHER|||||||0.04||95.0|||||Fisher Exact|||||||0.04
72326917|NCT00003869|144177299|SUPERIORITY_OR_OTHER|||||||0.18||95.0|||||Fisher Exact|||||||0.18
72326918|NCT01333436|144177356|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|21.8|STANDARD_DEVIATION|36.8||0.0078||95.0|||||t-test, 2 sided|||||||0.0078
72326919|NCT01333436|144177357|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|5.5|STANDARD_DEVIATION|13.9||0.0675||95.0|||||t-test, 2 sided|||||||0.0675
72326920|NCT01333436|144177358|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-1.4|STANDARD_DEVIATION|4.8||0.1798||95.0|||||t-test, 2 sided|||||||0.1798
72326921|NCT00444106|144177359|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||One-sided exact test for a single propn.|One-sided exact test for a single proportion.||"One-sided null hypothesis that the incidence rate of ABR Wave III latency changes is greater than or equal to 15%.~Increase in ABR Wave III latency between baseline and Day 7 of greater than 0.3 ms."||||<.0001
72326922|NCT00953706|144177375|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.7|STANDARD_ERROR_OF_MEAN|1.2||0.1509|TWO_SIDED|95.0|-0.6|4.1|||Mixed Models Analysis|||The primary analysis for the primary efficacy variable was based on a Mixed-Effects Model for Repeated Measures (MMRM). The model included absolute change from baseline in percent predicted forced expiratory volume in 1 second (FEV1) as the dependent variable, treatment (ivacaftor versus placebo) and visit as fixed effects, and participant as a random effect, with adjustment for age and continuous baseline value of percent predicted FEV1.||4.1|-0.6|0.1509
72326923|NCT00953706|144177376|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.3|STANDARD_ERROR_OF_MEAN|2.1||0.5408|TWO_SIDED|95.0|-2.9|5.6|||Mixed Models Analysis|||Analysis for the respiratory domain score endpoint was similar to that of the primary analysis of the primary efficacy endpoint. Estimates were from Mixed-Effects Model for Repeated Measures (MMRM) with the dependent variable being absolute change from baseline, fixed effects for categorical visit and treatment group, and adjustment for for age and baseline value for CFQ-R score, using unstructured covariance matrix||5.6|-2.9|0.5408
72326924|NCT00953706|144177377|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.9|STANDARD_ERROR_OF_MEAN|1.4||0.0384|TWO_SIDED|95.0|-5.6|-0.2|||Mixed Models Analysis|||Analysis for this variable was similar to that of the primary analysis of the primary efficacy endpoint. Estimates were from Mixed-Effects Model for Repeated Measures (MMRM) with dependent variable being absolute change from baseline, fixed effects for categorical visit and treatment group, and adjustment for continuous age and baseline value for age, sweat chloride, using unstructured covariance matrix.||-0.2|-5.6|0.0384
72326925|NCT00953706|144177378|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.5||0.7265|TWO_SIDED|95.0|-1.1|0.7|||Mixed Models Analysis|||The analysis used the linear mixed model with treatment as fixed effects, visit (days on study) and treatment by visit interaction as random effects, with adjustment for age group (\< 18 years and ≥ 18 years) and percent predicted forced expiratory volume (FEV1) severity (\< 70%, ≥ 70% to ≤ 90%, \> 90%) at screening, with random intercept and random slope. Rate of change in the study period is the slope of weight versus time (days) multiplied by the number of days in the study period (112 days).||0.7|-1.1|0.7265
72326926|NCT04050384|144177430|OTHER||||||<|0.001|||||||ANCOVA|These analyses apply to the Frontal, Central, and Central-Parietal regions.||||||<0.001
72326927|NCT04050384|144177431|OTHER|||||||0.38|||||||Wilcoxon (Mann-Whitney)|||||||0.38
72326928|NCT02292537|144177443|SUPERIORITY||LS Mean Difference|4.9|STANDARD_ERROR_OF_MEAN|0.91||1e-07|TWO_SIDED|95.0|3.1|6.7|||ANCOVA|ANCOVA model with treatment group as a factor and age at Screening and baseline HFMSE score as covariates.||||6.7|3.1|0.0000001
72326929|NCT02292537|144177444|SUPERIORITY||Odds Ratio (OR)|5.59||||0.0006|TWO_SIDED|95.0|2.09|14.91||Based on multiple imputation and logistic regression with treatment effect and adjustment for each participant's age at screening and HFMSE score at baseline.|Regression, Logistic|||||14.91|2.09|0.0006
72326930|NCT02292537|144177444|SUPERIORITY||Difference in Proportions|30.5|||||TWO_SIDED|95.0|12.74|48.31|||||Difference in proportions of Nusinersen minus Sham Procedure are from multiple imputation procedure and are based on binomial proportions.|||48.31|12.74|
72326931|NCT02292537|144177445|SUPERIORITY||Difference in Proportions|13.8||||0.0811|TWO_SIDED|95.0|-6.64|34.17|||Fisher Exact||Difference in proportions of Nusinersen minus Sham Procedure is based on exact unconditional confidence interval.|||34.17|-6.64|0.0811
72326932|NCT02292537|144177446|SUPERIORITY||LS Mean Difference|0.4|||||TWO_SIDED|95.0|0.2|0.7|||||Based on ANCOVA with treatment as a fixed effect and adjustment for each participant's age at screening and number of milestones at baseline.|||0.7|0.2|
72326933|NCT02292537|144177447|SUPERIORITY||LS Mean Differenec|3.7|||||TWO_SIDED|95.0|2.3|5.0|||||From multiple imputation procedure, based on ANCOVA with treatment as a fixed effect and adjustment for each participant's age at screening and derived total score at baseline.|||5.0|2.3|
72326934|NCT02292537|144177448|SUPERIORITY||Difference in Proportions|-1.4|||||TWO_SIDED|95.0|-21.84|19.34|||||Difference in proportions of Nusinersen minus Sham Procedure is based on exact unconditional confidence interval.|||19.34|-21.84|
72326935|NCT02292537|144177449|SUPERIORITY||Difference in Proportions|1.5|||||TWO_SIDED|95.0|-19.1|22.1|||||Difference in proportions of Nusinersen minus Sham Procedure is based on exact unconditional confidence interval.|||22.10|-19.10|
72326936|NCT01244035|144177519|OTHER||LS Mean difference|1.1||||0.1325|TWO_SIDED|90.0|-0.54|2.74|||Linear mixed effects model|Period and treatment were fixed effects and participant was a random effect.||||2.74|-0.54|0.1325
72326937|NCT01244035|144177519|OTHER||LS Mean difference|4.16|||<|0.001|TWO_SIDED|90.0|2.53|5.79|||Linear mixed effects model|Period and treatment were fixed effects and participant was a random effect.||||5.79|2.53|<0.001
72419429|NCT01194570|144349324|SUPERIORITY_OR_OTHER_LEGACY||Difference in Adjusted Means|0.377|STANDARD_ERROR_OF_MEAN|0.725||0.6034|TWO_SIDED|95.0|-1.048|1.802|||MMRM||Difference in adjusted mean was calculated as Ocrelizumab SF-36 Physical Component Summary Score - Placebo SF-36 Physical Component Summary Score.|Estimates are from analysis based on MMRM using unstructured covariance matrix: Change = Baseline PCS Score + Geographical Region (US vs. ROW) + Age (\<=45, \> 45 years) + Week + Treatment + Treatment\*Week (repeated values over Week) + Baseline PCS Score\*Week.||1.802|-1.048|0.6034
72419430|NCT01337674|144349331|NON_INFERIORITY_OR_EQUIVALENCE|Hypothesis: the upper bound of the 90% confidence interval for the difference in maximum change from baseline for MK-4618 + Met versus PBO + Met is \<20 mmHg|Mean Difference (Final Values)|-1.22|||||TWO_SIDED|90.0|-8.42|5.98|||||The estimated parameter is mean maximum change from baseline for placebo minus MK-4618. Mean and confidence interval for the difference were obtained from linear mixed effects model performed on the maximum increase from baseline values.|Semi-recumbent, Day 1||5.98|-8.42|
72612814|NCT01013753|144754271|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.128|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001||95.0|0.081|0.176|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo|||0.176|0.081|<0.0001
72419431|NCT01337674|144349331|NON_INFERIORITY_OR_EQUIVALENCE|Hypothesis: the upper bound of the 90% confidence interval for the difference in maximum change from baseline for MK-4618 + Met versus PBO + Met is \<20 mmHg|Mean Difference (Final Values)|2.29|||||TWO_SIDED|90.0|-4.92|9.49|||||The estimated parameter is mean maximum change from baseline for placebo minus MK-4618. Mean and confidence interval for the difference were obtained from linear mixed effects model performed on the maximum increase from baseline values.|Semi-recumbent, Day 7||9.49|-4.92|
72612815|NCT01013753|144754271|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.135|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001||95.0|0.087|0.183|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo|||0.183|0.087|<0.0001
72612816|NCT01013753|144754271|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.169|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001||95.0|0.121|0.217|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 20 mcg qd minus Placebo|||0.217|0.121|<0.0001
72612817|NCT01013753|144754271|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.093|STANDARD_ERROR_OF_MEAN|0.024||0.0001||95.0|0.045|0.141|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Form 12 mcg bid minus Placebo|||0.141|0.045|0.0001
72612818|NCT01013753|144754272|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.024||0.0362||95.0|0.003|0.097|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2 mcg qd minus Placebo|||0.097|0.003|0.0362
72612819|NCT01013753|144754272|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.081|STANDARD_ERROR_OF_MEAN|0.023||0.0006||95.0|0.035|0.127|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo|||0.127|0.035|0.0006
72612820|NCT01013753|144754272|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.088|STANDARD_ERROR_OF_MEAN|0.024||0.0002||95.0|0.042|0.135|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo|||0.135|0.042|0.0002
72612821|NCT01013753|144754272|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.117|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001||95.0|0.07|0.164|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 20 mcg qd minus Placebo|||0.164|0.070|<0.0001
72612822|NCT01013753|144754272|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.079|STANDARD_ERROR_OF_MEAN|0.024||0.001||95.0|0.032|0.125|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Form 12 mcg bid minus Placebo|||0.125|0.032|0.0010
72612823|NCT01013753|144754273|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.526|STANDARD_ERROR_OF_MEAN|0.124|<|0.0001||95.0|-0.77|-0.282|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2 mcg qd minus Placebo|||-0.282|-0.770|<0.0001
72612824|NCT01013753|144754273|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.432|STANDARD_ERROR_OF_MEAN|0.122||0.0004||95.0|-0.671|-0.192|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo|||-0.192|-0.671|0.0004
72612825|NCT01013753|144754273|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.478|STANDARD_ERROR_OF_MEAN|0.123||0.0001||95.0|-0.72|-0.237|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo|||-0.237|-0.720|0.0001
72612826|NCT01013753|144754273|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.657|STANDARD_ERROR_OF_MEAN|0.124|<|0.0001||95.0|-0.901|-0.413|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 20 mcg qd minus Placebo|||-0.413|-0.901|<0.0001
72612827|NCT01013753|144754273|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.449|STANDARD_ERROR_OF_MEAN|0.123||0.0003||95.0|-0.691|-0.207|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Form 12 mcg bid minus Placebo|||-0.207|-0.691|0.0003
72326938|NCT01244035|144177519|OTHER||LS Mean difference|-3.06||||0.0016|TWO_SIDED|90.0|-4.7|-1.42|||Linear mixed effects model|Period and treatment were fixed effects and participant was a random effect.||||-1.42|-4.70|0.0016
72419432|NCT01337674|144349331|NON_INFERIORITY_OR_EQUIVALENCE|Hypothesis: the upper bound of the 90% confidence interval for the difference in maximum change from baseline for MK-4618 + Met versus PBO + Met is \<20 mmHg|Mean Difference (Final Values)|1.65|||||TWO_SIDED|90.0|-5.31|8.62|||||The estimated parameter is mean maximum change from baseline for placebo minus MK-4618. Mean and confidence interval for the difference were obtained from linear mixed effects model performed on the maximum increase from baseline values.|Standing, Day 1||8.62|-5.31|
72326939|NCT01244035|144177520|OTHER||LS Mean difference|-2.94||||0.0212|TWO_SIDED|90.0|-5.3|-0.57|||Linear mixed effects model|Period and treatment were fixed effects and participant was a random effect.||||-0.57|-5.30|0.0212
72326940|NCT01244035|144177520|OTHER||LS Mean difference|-2.76||||0.0299|TWO_SIDED|90.0|-5.16|-0.36|||Linear mixed effects model|Period and treatment were fixed effects and participant was a random effect.||||-0.36|-5.16|0.0299
72326941|NCT01244035|144177520|OTHER||LS Mean difference|-0.18||||0.4506|TWO_SIDED|90.0|-2.54|2.19|||Linear mixed effects model|Period and treatment were fixed effects and participant was a random effect.||||2.19|-2.54|0.4506
72326942|NCT03723980|144177526|SUPERIORITY||Mean Difference (Net)|2.96||||0.329|TWO_SIDED|95.0||||"the calculated p value is for time interval of 4 hours~threshold for statistical significance= \<0.05"|ANOVA|For multiple comparisons between groups, post hoc (LSD) was applied||||||0.329
72326943|NCT03723980|144177526|SUPERIORITY||Mean Difference (Net)|-0.92||||0.764|TWO_SIDED|95.0||||"The calculated p value is for time interval of 12 hours~threshold for statistical significance= \<0.05"|ANOVA|||||||0.764
72419433|NCT01337674|144349331|NON_INFERIORITY_OR_EQUIVALENCE|Hypothesis: the upper bound of the 90% confidence interval for the difference in maximum change from baseline for MK-4618 + Met versus PBO + Met is \<20 mmHg|Mean Difference (Final Values)|-1.09|||||TWO_SIDED|90.0|-8.06|5.88|||||The estimated parameter is mean maximum change from baseline for placebo minus MK-4618. Mean and confidence interval for the difference were obtained from linear mixed effects model performed on the maximum increase from baseline values.|Standing, Day 7||5.88|-8.06|
72419434|NCT01337674|144349332|NON_INFERIORITY_OR_EQUIVALENCE|Hypothesis: the upper bound of the 90% confidence interval for the difference in maximum change from baseline for MK-4618 + Amlo versus PBO + Amlo is \<20 mmHg|Mean Difference (Final Values)|1.95|||||TWO_SIDED|90.0|-2.85|6.75|||||The estimated parameter is mean maximum change from baseline for placebo minus MK-4618. Mean and confidence interval for the difference were obtained from linear mixed effects model performed on the maximum increase from baseline values.|Semi-recumbent, Day 1||6.75|-2.85|
72326944|NCT03723980|144177526|SUPERIORITY||Mean Difference (Net)|-1.57||||0.605|TWO_SIDED|95.0||||"The calculated p value is for time interval of day 2~threshold for statistical significance= \<0.05"|ANOVA|||||||0.605
72326945|NCT03723980|144177526|SUPERIORITY||Mean Difference (Net)|-0.82||||0.786|TWO_SIDED|95.0||||"The calculated p value is for time interval of day 3~threshold for statistical significance= \<0.05"|ANOVA|||||||0.786
72326946|NCT03723980|144177526|SUPERIORITY||Mean Difference (Net)|-0.72||||0.813|TWO_SIDED|95.0||||"The calculated p value is for time interval of day 4~threshold for statistical significance= \<0.05"|ANOVA|||||||0.813
72326947|NCT03723980|144177528|OTHER||Mean Difference (Net)|2.97|STANDARD_ERROR_OF_MEAN|3.0||0.334|TWO_SIDED|95.0||||"The calculated p value is for the difference between pre-operative time interval and 4 hours time interval.~Threshold for statistical significance= \<0.05"|ANOVA|||||||0.334
72612828|NCT01013753|144754278|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.289|STANDARD_ERROR_OF_MEAN|0.057|<|0.0001||95.0|0.178|0.4|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2 mcg qd minus Placebo|||0.400|0.178|<0.0001
72612829|NCT01013753|144754278|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.209|STANDARD_ERROR_OF_MEAN|0.056||0.0002||95.0|0.099|0.318|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo|||0.318|0.099|0.0002
72612830|NCT01013753|144754278|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.262|STANDARD_ERROR_OF_MEAN|0.057|<|0.0001||95.0|0.151|0.374|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo|||0.374|0.151|<0.0001
72612831|NCT01013753|144754278|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.317|STANDARD_ERROR_OF_MEAN|0.057|<|0.0001||95.0|0.205|0.429|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 20 mcg qd minus Placebo|||0.429|0.205|<0.0001
72612832|NCT01013753|144754278|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.315|STANDARD_ERROR_OF_MEAN|0.057|<|0.0001||95.0|0.203|0.426|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Form 12 mcg bid minus Placebo|||0.426|0.203|<0.0001
72612833|NCT01013753|144754279|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.321|STANDARD_ERROR_OF_MEAN|0.057|<|0.0001||95.0|-0.432|-0.21|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2 mcg qd minus Placebo|||-0.210|-0.432|<0.0001
72612834|NCT01013753|144754279|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.293|STANDARD_ERROR_OF_MEAN|0.056|<|0.0001||95.0|-0.403|-0.184|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo|||-0.184|-0.403|<0.0001
72612835|NCT01013753|144754279|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.326|STANDARD_ERROR_OF_MEAN|0.056|<|0.0001||95.0|-0.436|-0.215|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo|||-0.215|-0.436|<0.0001
72612836|NCT01013753|144754279|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.394|STANDARD_ERROR_OF_MEAN|0.057|<|0.0001||95.0|-0.505|-0.282|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 20 mcg qd minus Placebo|||-0.282|-0.505|<0.0001
72612837|NCT01013753|144754279|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.346|STANDARD_ERROR_OF_MEAN|0.056|<|0.0001||95.0|-0.457|-0.235|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Form 12 mcg bid minus Placebo|||-0.235|-0.457|<0.0001
72612838|NCT01013753|144754280|SUPERIORITY_OR_OTHER||Ratio of geometric means|0.996||||0.6187||95.0|0.981|1.011|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2 mcg qd minus Placebo|||1.011|0.981|0.6187
72612839|NCT01013753|144754280|SUPERIORITY_OR_OTHER||Ratio of geometric means|0.996||||0.6022||95.0|0.981|1.011|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo|||1.011|0.981|0.6022
72612840|NCT01013753|144754280|SUPERIORITY_OR_OTHER||Ratio of geometric means|0.999||||0.8641||95.0|0.984|1.014|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo|||1.014|0.984|0.8641
72612841|NCT01013753|144754280|SUPERIORITY_OR_OTHER||Ratio of geometric means|0.998||||0.7664||95.0|0.983|1.013|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 20 mcg qd minus Placebo|||1.013|0.983|0.7664
72612842|NCT01013753|144754280|SUPERIORITY_OR_OTHER||Ratio of geometric means|1.003||||0.6757||95.0|0.988|1.018|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Form 12 mcg bid minus Placebo|||1.018|0.988|0.6757
72612843|NCT01013753|144754281|SUPERIORITY_OR_OTHER||Ratio of geometric means|0.993||||0.4423||95.0|0.975|1.011|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2 mcg qd minus Placebo|||1.011|0.975|0.4423
72612844|NCT01013753|144754281|SUPERIORITY_OR_OTHER||Ratio of geometric means|0.979||||0.0218||95.0|0.962|0.997|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo|||0.997|0.962|0.0218
72612845|NCT01013753|144754281|SUPERIORITY_OR_OTHER||Ratio of geometric means|0.977||||0.0109||95.0|0.96|0.995|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo|||0.995|0.960|0.0109
72612846|NCT01013753|144754281|SUPERIORITY_OR_OTHER||Ratio of geometric means|0.98||||0.0283||95.0|0.962|0.998|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 20 mcg qd minus Placebo|||0.998|0.962|0.0283
72612847|NCT01013753|144754281|SUPERIORITY_OR_OTHER||Ratio of geometric means|0.991||||0.3085||95.0|0.973|1.009|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Form 12 mcg bid minus Placebo|||1.009|0.973|0.3085
72612848|NCT01013753|144754282|SUPERIORITY_OR_OTHER||Ratio of geometric means|0.999||||0.9112||95.0|0.984|1.015|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2 mcg qd minus Placebo|||1.015|0.984|0.9112
72612849|NCT01013753|144754282|SUPERIORITY_OR_OTHER||Ratio of geometric means|0.992||||0.2955||95.0|0.977|1.007|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo|||1.007|0.977|0.2955
72612850|NCT01013753|144754282|SUPERIORITY_OR_OTHER||Ratio of geometric means|0.987||||0.1029||95.0|0.973|1.003|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo|||1.003|0.973|0.1029
72419435|NCT01337674|144349332|NON_INFERIORITY_OR_EQUIVALENCE|Hypothesis: the upper bound of the 90% confidence interval for the difference in maximum change from baseline for MK-4618 + Amlo versus PBO + Amlo is \<20 mmHg|Mean Difference (Final Values)|-5.91|||||TWO_SIDED|90.0|-10.71|-1.11|||||The estimated parameter is mean maximum change from baseline for placebo minus MK-4618. Mean and confidence interval for the difference were obtained from linear mixed effects model performed on the maximum increase from baseline values.|Semi-recumbent, Day 7||-1.11|-10.71|
72612851|NCT01013753|144754282|SUPERIORITY_OR_OTHER||Ratio of geometric means|0.991||||0.2552||95.0|0.975|1.007|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 20 mcg qd minus Placebo|||1.007|0.975|0.2552
72612852|NCT01013753|144754282|SUPERIORITY_OR_OTHER||Ratio of geometric means|0.994||||0.4803||95.0|0.979|1.01|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Form 12 mcg bid minus Placebo|||1.010|0.979|0.4803
72612853|NCT03320369|144754295|OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
72612854|NCT01732692|144754299|NON_INFERIORITY_OR_EQUIVALENCE|The primary endpoint was analyzed by a non-inferiority test using the exact Farrington-Manning method. Non-inferiority of the two treatments was to be concluded if the lower end of the confidence interval of the difference the experimental treatment group (morning-only dose) - control treatment group (split dose) was above a non-inferiority margin of -0.15%.|Treatment Difference|0.0286|||<|0.001|ONE_SIDED|95.0|-0.097||||Exact Farrington - Manning||Treatment Difference is the difference in proportion of participants with successful colon cleansing between treatments -experimental vs. control||||-0.097|<0.001
72612855|NCT00435942|144754305|NON_INFERIORITY_OR_EQUIVALENCE|The proportion of subjects in the Effectiveness sample who were free from major device-related AEs at 1-year post-procedure was compared against a performance goal of 0.80 using a 1-sided z-test (normal approximation to the binomial) at an alpha level of 0.025. Rejection of the null hypothesis would provide evidence that this performance goal (proportion-free greater than 0.80) was met.|Proportion free|0.97|||>|0.8|ONE_SIDED|97.5|0.93||||1-sided z-test|97.5% 1-sided confidence interval||The proportion of subjects in the Effectiveness sample who were free from major device-related AEs at 1-year post-procedure was compared against a performance goal of 0.80 using a 1-sided z-test (normal approximation to the binomial) at an alpha level of 0.025. Rejection of the null hypothesis would provide evidence that this performance goal (proportion-free greater than 0.80) was met.|||.93|>0.80
72612856|NCT03755076|144754333|SUPERIORITY||||||<|0.001|||||||ANOVA|||||||<0.001
72612857|NCT03755076|144754334|SUPERIORITY||||||<|0.001|||||||ANOVA|||||||<0.001
72612858|NCT01953237|144754335|SUPERIORITY_OR_OTHER_LEGACY|||||||0.558|||||||Mixed Models Analysis|||||||0.5580
72612859|NCT04167462|144754336|SUPERIORITY||Odds Ratio (OR)|16.49|||<|0.0001|TWO_SIDED|95.0|6.33|42.98|||Cochran-Mantel-Haenszel|||||42.98|6.33|<0.0001
72612860|NCT04167462|144754337|SUPERIORITY||Odds Ratio (OR)|24.29|||<|0.0001|TWO_SIDED|95.0|9.6|61.46|||Cochran-Mantel-Haenszel|||||61.46|9.60|<0.0001
72612861|NCT04167462|144754338|SUPERIORITY||Odds Ratio (OR)|41.19|||<|0.0001|TWO_SIDED|95.0|5.82|291.26|||Cochran-Mantel-Haenszel|||||291.26|5.82|<0.0001
72612862|NCT04167462|144754342|SUPERIORITY||Odds Ratio (OR)|17.27|||<|0.0001|TWO_SIDED|95.0|6.06|49.25|||Cochran-Mantel-Haenszel|||||49.25|6.06|<0.0001
72612863|NCT04167462|144754343|SUPERIORITY||Odds Ratio (OR)|5.1|||<|0.0001|TWO_SIDED|95.0|2.19|11.91|||Cochran-Mantel-Haenszel|||||11.91|2.19|<0.0001
72612864|NCT04167462|144754344|SUPERIORITY||Odds Ratio (OR)|5.86||||0.0947|TWO_SIDED|95.0|0.64|53.28|||Cochran-Mantel-Haenszel|||||53.28|0.64|0.0947
72612865|NCT04167462|144754345|SUPERIORITY||Odds Ratio (OR)|4.11||||0.1741|TWO_SIDED|95.0|0.47|35.74|||Cochran-Mantel-Haenszel|||||35.74|0.47|0.1741
72612866|NCT05383209|144754416|OTHER||Difference in response percentage|-5.0|||||TWO_SIDED|95.0|-24.9|13.4||||||||13.4|-24.9|
72612867|NCT05383209|144754416|OTHER||Slope|-0.2|||||TWO_SIDED|95.0|-20.6|20.6||||||||20.6|-20.6|
72612868|NCT05383209|144754417|OTHER||Difference in response percentage|5.3|||||TWO_SIDED|95.0|-13.2|26.0||||||||26.0|-13.2|
72612869|NCT00149643|144754447|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0|||||ANOVA|||Groups' categorical baseline measures were compared by chi-square analysis, corrected for continuity. Statistical analyses were completed on an intent to-treat study group basis. Outcome measures for depression and for cannabis use and alcohol use across treatment groups were compared by repeated measures analysis of variance. The last observation carried forward (LOCF)method was used for handling missing data in the data analyses.||||<0.05
72612870|NCT06525727|144754450|OTHER||Sensitivity|97.96|||||TWO_SIDED|95.0|89.15|99.95|||Diagnostic accuracy|Diagnostic performance was analyzed in terms of sensitivity, specificity, NPV, PPV and likelihood ratios, all reported with 95% confidence interval||The primary objective of the study was to assess the external validation of the Falls Decision Rule. In this evaluation, patients were categorized into two groups based on the rule: those for whom a CT scan was recommended and those for whom it was not.||99.95|89.15|
72612871|NCT06525727|144754450|OTHER||Specificity|31.96|||||TWO_SIDED|95.0|28.63|35.42|||Diagnostic accuracy|||||35.42|28.63|
72612872|NCT06525727|144754450|OTHER||Negative predictive value|99.59|||||TWO_SIDED|95.0|97.17|99.94|||Diagnostic accuracy|||||99.94|97.17|
72612873|NCT06525727|144754450|OTHER||Positive predictive value|8.59|||||TWO_SIDED|95.0|8.1|9.1|||Diagnostic accuracy|||||9.1|8.1|
72612874|NCT06525727|144754450|OTHER||Negative likelihood ratio|0.06|||||TWO_SIDED|95.0|0.01|0.42|||Diagnostic accuracy|||||0.42|0.01|
72612875|NCT06525727|144754450|OTHER||Positive likelihood ratio|1.44|||||TWO_SIDED|95.0|1.35|1.53|||Diagnostic accuracy|||||1.53|1.35|
72612876|NCT04666298|144754453|SUPERIORITY||Mean Difference (Net)|-56.6|STANDARD_ERROR_OF_MEAN|3.24|<|0.0001|TWO_SIDED|95.0|-64.2|-49.0||One-sided adjusted p-value for multiple comparisons using Dunnett´s multiple t-test|Mixed Models Analysis|||||-49.0|-64.2|<.0001
72612877|NCT04666298|144754453|SUPERIORITY||Mean Difference (Net)|-60.9|STANDARD_ERROR_OF_MEAN|2.84|<|0.0001|TWO_SIDED|95.0|-67.6|-54.3||One-sided adjusted p-value for multiple comparisons using Dunnett´s multiple t-test|Mixed Models Analysis|||||-54.3|-67.6|<.0001
72612878|NCT04666298|144754453|SUPERIORITY||Mean Difference (Net)|-65.3|STANDARD_ERROR_OF_MEAN|2.86|<|0.0001|TWO_SIDED|95.0|-72.0|-58.6||One-sided adjusted p-value for multiple comparisons using Dunnett´s multiple t-test|Mixed Models Analysis|||||-58.6|-72.0|<.0001
72419436|NCT01337674|144349332|NON_INFERIORITY_OR_EQUIVALENCE|Hypothesis: the upper bound of the 90% confidence interval for the difference in maximum change from baseline for MK-4618 + Amlo versus PBO + Amlo is \<20 mmHg|Mean Difference (Final Values)|-6.25|||||TWO_SIDED|90.0|-11.47|-1.03|||||The estimated parameter is mean maximum change from baseline for placebo minus MK-4618. Mean and confidence interval for the difference were obtained from linear mixed effects model performed on the maximum increase from baseline values.|Standing, Day 1||-1.03|-11.47|
72419437|NCT01337674|144349332|NON_INFERIORITY_OR_EQUIVALENCE|Hypothesis: the upper bound of the 90% confidence interval for the difference in maximum change from baseline for MK-4618 + Amlo versus PBO + Amlo is \<20 mmHg|Mean Difference (Final Values)|-1.57|||||TWO_SIDED|90.0|-6.79|3.65|||||The estimated parameter is mean maximum change from baseline for placebo minus MK-4618. Mean and confidence interval for the difference were obtained from linear mixed effects model performed on the maximum increase from baseline values.|Standing, Day 7||3.65|-6.79|
72419438|NCT02673398|144349357|SUPERIORITY||Mean Difference (Final Values)|-0.41||||0.05|TWO_SIDED|95.0|-0.82|0.01|||t-test, 2 sided||Patients with higher risk scores were more likely to require a dose reduction. The lack of significance is most likely due to the small sample size.|Student's t-test was used to assess if geriatric risk score differed depending on whether or not a participant had a dose reduction (mean difference log2 risk = no dose modification - dose modification).||0.01|-0.82|0.05
72419439|NCT02673398|144349357|SUPERIORITY||Slope|-1.29|STANDARD_ERROR_OF_MEAN|1.44||0.39|TWO_SIDED||||||Regression, Linear|||Linear regression was used to assess whether log2 geriatric toxicity risk score was a risk factor for the number of course completed.||||0.39
72419440|NCT02673398|144349358|SUPERIORITY||Slope|-0.093|STANDARD_ERROR_OF_MEAN|0.0398||0.03|TWO_SIDED||||||Regression, Linear||The older the participant the lower the steady state value.|Least squares regression was used to assess the relationship between steady state neratinib concentration and age||||0.03
72419441|NCT02673398|144349358|SUPERIORITY||Slope|1.4|STANDARD_DEVIATION|2.39||0.57|TWO_SIDED||||||Regression, Linear||Geriatric risk score was not predictive of steady state concentration.|Least squares regression was used to determine if geriatric toxicity risk score at baseline was predictive of steady state neratinib concentration.||||0.57
72612879|NCT01311661|144754472|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.191|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001||95.0|0.152|0.229|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2.5 mcg bid minus Placebo|||0.229|0.152|<0.0001
72326948|NCT03723980|144177528|OTHER||Mean Difference (Net)|2.33|STANDARD_ERROR_OF_MEAN|3.0||0.448|TWO_SIDED|95.0||||"The calculated p value is for the difference between time interval of 4 hours and time interval of 12 hours.~Threshold for statistical significance= \<0.05"|ANOVA|||||||0.448
72326949|NCT03723980|144177528|OTHER||Mean Difference (Net)|5.88|STANDARD_ERROR_OF_MEAN|3.0||0.056|TWO_SIDED|95.0||||"The calculated p value is for the difference between time intervals of 12 hours and day 2~Threshold for statistical significance= \<0.05"|ANOVA|||||||0.056
72419442|NCT01321554|144349359|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|0.21|||||TWO_SIDED|99.0|0.14|0.31||||||||0.31|0.14|
72419443|NCT01111123|144349363|SUPERIORITY_OR_OTHER||||||<|0.05||95.0||||CI of 95%|Log Rank|||Probabilities of PGA not worsening were estimated using the Kaplan-Meier product limit method with a comparison between treatment group survival curves evaluated by the log-rank test statistic. The Cox proportional hazards model was used to estimate the hazard ratio for worsening of PGA (equivalent to a relative risk adjusted for follow-up time) and a corresponding 95-percent confidence interval.||||<0.05
72419444|NCT01111123|144349364|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||ANCOVA|||Secondary outcomes, including subject self-assessment and signs of psoriasis ratings, were analyzed as continuous dependent variables in these statistical models. Mixed modeling analysis of covariance (ANCOVA) was used to compare the relationships between psoriasis symptoms over time in the placebo and steroid treatment groups||||<0.05
72612880|NCT01311661|144754472|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.15|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001||95.0|0.111|0.189|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo|||0.189|0.111|<0.0001
72612881|NCT01311661|144754472|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.228|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001||95.0|0.19|0.266|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg bid minus Placebo|||0.266|0.190|<0.0001
72612882|NCT01311661|144754472|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.209|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001||95.0|0.17|0.247|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo|||0.247|0.170|<0.0001
72612883|NCT01311661|144754473|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.19|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001||95.0|0.15|0.229|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2.5 mcg bid minus Placebo|||0.229|0.150|<0.0001
72326950|NCT03723980|144177528|OTHER||Mean Difference (Net)|0.94|STANDARD_ERROR_OF_MEAN|3.0||0.76|TWO_SIDED|95.0||||"The calculated p value is for the difference between time intervals of day 2 and day 3~Threshold for statistical significance= \<0.05"|ANOVA|||||||0.760
72326951|NCT03723980|144177528|OTHER||Mean Difference (Net)|0.67|STANDARD_ERROR_OF_MEAN|3.0||0.828|TWO_SIDED|95.0||||"The calculated p value is for the difference between time intervals of day 3 and day 4~Threshold for statistical significance= \<0.05"|ANOVA|||||||0.828
72612884|NCT01311661|144754473|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.16|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001||95.0|0.121|0.199|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo|||0.199|0.121|<0.0001
72612885|NCT01311661|144754473|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.214|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001||95.0|0.175|0.253|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg bid minus Placebo|||0.253|0.175|<0.0001
72326952|NCT03723980|144177528|OTHER||Mean Difference (Net)|11.8|STANDARD_ERROR_OF_MEAN|2.9||0|TWO_SIDED|95.0||||"The calculated p value is for the difference between pre-operative time interval and 4 hours time interval~Threshold for statistical significance= \<0.05"|ANOVA|||||||0.000
72326953|NCT03723980|144177528|OTHER||Mean Difference (Net)|-1.54|STANDARD_ERROR_OF_MEAN|2.9||0.605|TWO_SIDED|95.0||||"The calculated p value is for the difference between time interval of 4 hours and time interval of 12 hours~Threshold for statistical significance= \<0.05"|ANOVA|||||||0.605
72612886|NCT01311661|144754473|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.219|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001||95.0|0.181|0.258|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo|||0.258|0.181|<0.0001
72612887|NCT01311661|144754474|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.196|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001||95.0|0.153|0.238|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2.5 mcg bid minus Placebo|||0.238|0.153|<0.0001
72612888|NCT01311661|144754474|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.144|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001||95.0|0.102|0.187|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo|||0.187|0.102|<0.0001
72612889|NCT01311661|144754474|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.242|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001||95.0|0.2|0.285|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg bid minus Placebo|||0.285|0.200|<0.0001
72612890|NCT01311661|144754474|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.198|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001||95.0|0.156|0.241|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo|||0.241|0.156|<0.0001
72612891|NCT01311661|144754475|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.183|STANDARD_ERROR_OF_MEAN|0.023|<|0.0001||95.0|0.138|0.228|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2.5 mcg bid minus Placebo|||0.228|0.138|<0.0001
72612892|NCT01311661|144754475|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.153|STANDARD_ERROR_OF_MEAN|0.023|<|0.0001||95.0|0.108|0.198|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo|||0.198|0.108|<0.0001
72612893|NCT01311661|144754475|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.222|STANDARD_ERROR_OF_MEAN|0.023|<|0.0001||95.0|0.177|0.267|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg bid minus Placebo|||0.267|0.177|<0.0001
72612894|NCT01311661|144754475|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.21|STANDARD_ERROR_OF_MEAN|0.023|<|0.0001||95.0|0.165|0.255|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo|||0.255|0.165|<0.0001
72612895|NCT01311661|144754476|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.156|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001||95.0|0.109|0.203|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2.5 mcg bid minus Placebo|||0.203|0.109|<0.0001
72612896|NCT01311661|144754476|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.101|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001||95.0|0.054|0.148|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo|||0.148|0.054|<0.0001
72612897|NCT01311661|144754476|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.196|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001||95.0|0.149|0.243|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg bid minus Placebo|||0.243|0.149|<0.0001
72612898|NCT01311661|144754476|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.172|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001||95.0|0.125|0.219|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo|||0.219|0.125|<0.0001
72612899|NCT01311661|144754477|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.136|STANDARD_ERROR_OF_MEAN|0.023|<|0.0001||95.0|0.091|0.18|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2.5 mcg bid minus Placebo|||0.180|0.091|<0.0001
72612900|NCT01311661|144754477|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.122|STANDARD_ERROR_OF_MEAN|0.023|<|0.0001||95.0|0.078|0.167|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo|||0.167|0.078|<0.0001
72612901|NCT01311661|144754477|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.142|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001||95.0|0.098|0.186|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg bid minus Placebo|||0.186|0.098|<0.0001
72612902|NCT01311661|144754477|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.147|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001||95.0|0.103|0.191|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo|||0.191|0.103|<0.0001
72612903|NCT01311661|144754478|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.158|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001||95.0|0.11|0.206|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2.5 mcg bid minus Placebo|||0.206|0.110|<0.0001
72612904|NCT01311661|144754478|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.137|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001||95.0|0.09|0.185|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo|||0.185|0.090|<0.0001
72612905|NCT01311661|144754478|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.17|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001||95.0|0.123|0.218|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg bid minus Placebo|||0.218|0.123|<0.0001
72326954|NCT03723980|144177528|OTHER||Mean Difference (Net)|5.23|STANDARD_ERROR_OF_MEAN|2.9||0.8|TWO_SIDED|95.0||||"The calculated p value is for the difference between time intervals of 12 hours and day 2~Threshold for statistical significance= \<0.05"|ANOVA|||||||0.80
72419445|NCT04676425|144349376|OTHER||Least-Squares Geometric Mean Ratio|1.19|||||TWO_SIDED|90.0|0.7|2.01|||||Moderate hepatic impairment participants represent the numerator and healthy participants represent the denominator in the geometric mean ratio.|||2.01|0.70|
72419446|NCT04676425|144349377|OTHER||Least-Squares Geometric Mean Ratio|1.22|||||TWO_SIDED|90.0|0.86|1.74|||||Moderate hepatic impairment participants represent the numerator and healthy participants represent the denominator in the geometric mean ratio.|||1.74|0.86|
72612906|NCT01311661|144754478|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.135|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001||95.0|0.087|0.182|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo|||0.182|0.087|<0.0001
72612907|NCT01311661|144754479|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.145|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001||95.0|0.102|0.188|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2.5 mcg bid minus Placebo|||0.188|0.102|<0.0001
72612908|NCT01311661|144754479|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.128|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001||95.0|0.085|0.171|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo|||0.171|0.085|<0.0001
72612909|NCT01311661|144754479|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.156|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001||95.0|0.113|0.198|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg bid minus Placebo|||0.198|0.113|<0.0001
72326955|NCT03723980|144177528|OTHER||Mean Difference (Net)|1.69|STANDARD_ERROR_OF_MEAN|2.9||0.574|TWO_SIDED|95.0||||"The calculated p value is for the difference between time intervals of day 2 and day 3~Threshold for statistical significance= \<0.05"|ANOVA|||||||0.574
72612910|NCT01311661|144754479|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.14|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001||95.0|0.098|0.182|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo|||0.182|0.098|<0.0001
72612911|NCT01311661|144754480|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.136|STANDARD_ERROR_OF_MEAN|0.026|<|0.0001||95.0|0.084|0.187|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2.5 mcg bid minus Placebo|||0.187|0.084|<0.0001
72612912|NCT01311661|144754480|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.124|STANDARD_ERROR_OF_MEAN|0.026|<|0.0001||95.0|0.073|0.176|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo|||0.176|0.073|<0.0001
72612913|NCT01311661|144754480|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.144|STANDARD_ERROR_OF_MEAN|0.026|<|0.0001||95.0|0.093|0.195|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg bid minus Placebo|||0.195|0.093|<0.0001
72612914|NCT01311661|144754480|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.126|STANDARD_ERROR_OF_MEAN|0.026|<|0.0001||95.0|0.075|0.177|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo|||0.177|0.075|<0.0001
72612915|NCT01311661|144754481|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.11|STANDARD_ERROR_OF_MEAN|0.028||0.0001||95.0|0.055|0.165|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2.5 mcg bid minus Placebo|||0.165|0.055|0.0001
72612916|NCT01311661|144754481|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.092|STANDARD_ERROR_OF_MEAN|0.028||0.001||95.0|0.037|0.147|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo|||0.147|0.037|0.0010
72612917|NCT01311661|144754481|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.118|STANDARD_ERROR_OF_MEAN|0.028|<|0.0001||95.0|0.063|0.172|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg bid minus Placebo|||0.172|0.063|<0.0001
72612918|NCT01311661|144754481|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.111|STANDARD_ERROR_OF_MEAN|0.028|<|0.0001||95.0|0.057|0.166|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo|||0.166|0.057|<0.0001
72612919|NCT01311661|144754482|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.629|STANDARD_ERROR_OF_MEAN|0.065|<|0.0001||95.0|0.5|0.757|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2.5 mcg bid minus Placebo|||0.757|0.500|<0.0001
72612920|NCT01311661|144754482|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.601|STANDARD_ERROR_OF_MEAN|0.065|<|0.0001||95.0|0.473|0.73|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo|||0.730|0.473|<0.0001
72612921|NCT01311661|144754482|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.631|STANDARD_ERROR_OF_MEAN|0.065|<|0.0001||95.0|0.503|0.758|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg bid minus Placebo|||0.758|0.503|<0.0001
72612922|NCT01311661|144754482|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.685|STANDARD_ERROR_OF_MEAN|0.065|<|0.0001||95.0|0.558|0.813|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo|||0.813|0.558|<0.0001
72612923|NCT01311661|144754483|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.665|STANDARD_ERROR_OF_MEAN|0.068|<|0.0001||95.0|0.532|0.799|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2.5 mcg bid minus Placebo|||0.799|0.532|<0.0001
72612924|NCT01311661|144754483|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.564|STANDARD_ERROR_OF_MEAN|0.068|<|0.0001||95.0|0.431|0.698|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo|||0.698|0.431|<0.0001
72612925|NCT01311661|144754483|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.702|STANDARD_ERROR_OF_MEAN|0.068|<|0.0001||95.0|0.569|0.835|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg bid minus Placebo|||0.835|0.569|<0.0001
72612926|NCT01311661|144754483|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.599|STANDARD_ERROR_OF_MEAN|0.067|<|0.0001||95.0|0.467|0.732|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo|||0.732|0.467|<0.0001
72612927|NCT01311661|144754484|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.641|STANDARD_ERROR_OF_MEAN|0.063|<|0.0001||95.0|0.516|0.765|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2.5 mcg bid minus Placebo|||0.765|0.516|<0.0001
72612928|NCT01311661|144754484|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.577|STANDARD_ERROR_OF_MEAN|0.063|<|0.0001||95.0|0.453|0.701|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo|||0.701|0.453|<0.0001
72612929|NCT01311661|144754484|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.667|STANDARD_ERROR_OF_MEAN|0.063|<|0.0001||95.0|0.544|0.79|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg bid minus Placebo|||0.790|0.544|<0.0001
72612930|NCT01311661|144754484|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.643|STANDARD_ERROR_OF_MEAN|0.063|<|0.0001||95.0|0.519|0.766|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo|||0.766|0.519|<0.0001
72326956|NCT03723980|144177528|OTHER||Mean Difference (Net)|0.77|STANDARD_ERROR_OF_MEAN|2.9||0.796|TWO_SIDED|95.0||||"The calculated p value is for the difference between time intervals of day 3 and day 4~Threshold for statistical significance= \<0.05"|ANOVA|||||||0.796
72612931|NCT01311661|144754485|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.591|STANDARD_ERROR_OF_MEAN|0.079|<|0.0001||95.0|0.436|0.746|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2.5 mcg bid minus Placebo|||0.746|0.436|<0.0001
72612932|NCT01311661|144754485|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.522|STANDARD_ERROR_OF_MEAN|0.079|<|0.0001||95.0|0.366|0.677|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo|||0.677|0.366|<0.0001
72612933|NCT01311661|144754485|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.594|STANDARD_ERROR_OF_MEAN|0.079|<|0.0001||95.0|0.439|0.749|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg bid minus Placebo|||0.749|0.439|<0.0001
72612934|NCT01311661|144754485|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.623|STANDARD_ERROR_OF_MEAN|0.079|<|0.0001||95.0|0.468|0.777|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo|||0.777|0.468|<0.0001
72612935|NCT01311661|144754486|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.529|STANDARD_ERROR_OF_MEAN|0.068|<|0.0001||95.0|0.396|0.662|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2.5 mcg bid minus Placebo|||0.662|0.396|<0.0001
72612936|NCT01311661|144754486|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.41|STANDARD_ERROR_OF_MEAN|0.068|<|0.0001||95.0|0.277|0.543|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo|||0.543|0.277|<0.0001
72612937|NCT01311661|144754486|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.603|STANDARD_ERROR_OF_MEAN|0.067|<|0.0001||95.0|0.471|0.736|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg bid minus Placebo|||0.736|0.471|<0.0001
72612938|NCT01311661|144754486|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.481|STANDARD_ERROR_OF_MEAN|0.067|<|0.0001||95.0|0.349|0.613|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo|||0.613|0.349|<0.0001
72612939|NCT01311661|144754487|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|32.957|STANDARD_ERROR_OF_MEAN|3.18|<|0.0001||95.0|26.709|39.206|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2.5 mcg bid minus Placebo|||39.206|26.709|<0.0001
72612940|NCT01311661|144754487|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|32.632|STANDARD_ERROR_OF_MEAN|3.167|<|0.0001||95.0|26.409|38.855|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo|||38.855|26.409|<0.0001
72612941|NCT01311661|144754487|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|31.66|STANDARD_ERROR_OF_MEAN|3.161|<|0.0001||95.0|25.448|37.872|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg bid minus Placebo|||37.872|25.448|<0.0001
72612942|NCT01311661|144754487|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|28.895|STANDARD_ERROR_OF_MEAN|3.161|<|0.0001||95.0|22.683|35.107|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo|||35.107|22.683|<0.0001
72612943|NCT01311661|144754488|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|28.87|STANDARD_ERROR_OF_MEAN|3.046|<|0.0001||95.0|22.884|34.856|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2.5 mcg bid minus Placebo|||34.856|22.884|<0.0001
72612944|NCT01311661|144754488|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|32.056|STANDARD_ERROR_OF_MEAN|3.034|<|0.0001||95.0|26.094|38.018|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo|||38.018|26.094|<0.0001
72612945|NCT01311661|144754488|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|31.816|STANDARD_ERROR_OF_MEAN|3.028|<|0.0001||95.0|25.864|37.767|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg bid minus Placebo|||37.767|25.864|<0.0001
72612946|NCT01311661|144754488|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|33.327|STANDARD_ERROR_OF_MEAN|3.028|<|0.0001||95.0|27.375|39.278|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo|||39.278|27.375|<0.0001
72612947|NCT01311661|144754489|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.581|STANDARD_ERROR_OF_MEAN|0.346|<|0.0001||95.0|-2.262|-0.9|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2.5 mcg bid minus Placebo|||-0.900|-2.262|<0.0001
72612948|NCT01311661|144754489|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.426|STANDARD_ERROR_OF_MEAN|0.345|<|0.0001||95.0|-2.104|-0.748|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo|||-0.748|-2.104|<0.0001
72612949|NCT01311661|144754489|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.738|STANDARD_ERROR_OF_MEAN|0.344|<|0.0001||95.0|-2.415|-1.062|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg bid minus Placebo|||-1.062|-2.415|<0.0001
72612950|NCT01311661|144754489|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.689|STANDARD_ERROR_OF_MEAN|0.344||0.0458||95.0|-1.366|-0.013|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo|||-0.013|-1.366|0.0458
72612951|NCT01311661|144754490|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|173.391|STANDARD_ERROR_OF_MEAN|19.484|<|0.0001||95.0|135.099|211.682|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2.5 mcg bid minus Placebo|||211.682|135.099|<0.0001
72612952|NCT01311661|144754490|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|155.097|STANDARD_ERROR_OF_MEAN|19.406|<|0.0001||95.0|116.961|193.234|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo|||193.234|116.961|<0.0001
72612953|NCT01311661|144754490|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|149.268|STANDARD_ERROR_OF_MEAN|19.369|<|0.0001||95.0|111.204|187.333|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg bid minus Placebo|||187.333|111.204|<0.0001
72612954|NCT01311661|144754490|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|150.441|STANDARD_ERROR_OF_MEAN|19.369|<|0.0001||95.0|112.377|188.505|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo|||188.505|112.377|<0.0001
72612955|NCT01311661|144754491|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|142.251|STANDARD_ERROR_OF_MEAN|18.997|<|0.0001||95.0|104.916|179.586|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2.5 mcg bid minus Placebo|||179.586|104.916|<0.0001
72612956|NCT01311661|144754491|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|132.138|STANDARD_ERROR_OF_MEAN|18.92|<|0.0001||95.0|94.954|169.322|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo|||169.322|94.954|<0.0001
72612957|NCT01311661|144754491|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|142.136|STANDARD_ERROR_OF_MEAN|18.885|<|0.0001||95.0|105.021|179.251|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg bid minus Placebo|||179.251|105.021|<0.0001
72612958|NCT01311661|144754491|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|157.306|STANDARD_ERROR_OF_MEAN|18.885|<|0.0001||95.0|120.192|194.42|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo|||194.420|120.192|<0.0001
72612959|NCT01311661|144754492|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.554|STANDARD_ERROR_OF_MEAN|0.115|<|0.0001||95.0|-0.78|-0.329|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2.5 mcg bid minus Placebo|||-0.329|-0.780|<0.0001
72612960|NCT01311661|144754492|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.637|STANDARD_ERROR_OF_MEAN|0.114|<|0.0001||95.0|-0.862|-0.412|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo|||-0.412|-0.862|<0.0001
72612961|NCT01311661|144754492|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.588|STANDARD_ERROR_OF_MEAN|0.114|<|0.0001||95.0|-0.813|-0.364|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg bid minus Placebo|||-0.364|-0.813|<0.0001
72612962|NCT01311661|144754492|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.546|STANDARD_ERROR_OF_MEAN|0.114|<|0.0001||95.0|-0.77|-0.322|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo|||-0.322|-0.770|<0.0001
72612963|NCT01311661|144754497|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.357|STANDARD_ERROR_OF_MEAN|0.053|<|0.0001||95.0|-0.461|-0.253|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2.5 mcg bid minus Placebo|||-0.253|-0.461|<0.0001
72326957|NCT03723980|144177529|OTHER||Mean Difference (Net)|-0.6||||0.412|TWO_SIDED|||||"The p-value calculated is for pain score difference at 4 hours~Threshold for statistical significance= \<0.05"|Wilcoxon (Mann-Whitney)|||||||0.412
72326958|NCT03723980|144177529|OTHER||Mean Difference (Net)|2.8||||0.94|TWO_SIDED|||||"The p-value calculated is for pain score difference at 12 hours~Threshold for statistical significance= \<0.05"|Wilcoxon (Mann-Whitney)|||||||0.94
72326959|NCT03723980|144177529|OTHER||Mean Difference (Net)|5.5||||0.035|TWO_SIDED|||||"The p-value calculated is for pain score difference at Day 2~Threshold for statistical significance= \<0.05"|Wilcoxon (Mann-Whitney)|||||||0.035
72326960|NCT03723980|144177529|OTHER||Mean Difference (Net)|4.4||||0.023|TWO_SIDED|||||"The p-value calculated is for pain score difference at Day 3~Threshold for statistical significance= \<0.05"|Wilcoxon (Mann-Whitney)|||||||0.023
72326961|NCT03723980|144177529|OTHER||Median Difference (Net)|4.3||||0.02|TWO_SIDED|||||"The p-value calculated is for pain score difference at Day 4.~Threshold for statistical significance= \<0.05"|Wilcoxon (Mann-Whitney)|||||||0.020
72419447|NCT02178059|144349393|NON_INFERIORITY_OR_EQUIVALENCE|Approximately 34 healthy volunteers will be entered into the study in order to complete 30 evaluable volunteers. Based on the study SD-001-0268, a residual intra-individual standard deviation of 0.300/sqrt(2) = 0.212 can be expected on the natural log scale. With 30 completed volunteers there will be a 93% chance that the upper limits of two-sided 90% CI for Cmax and AUC ratios are \<1.25 provided that the true mean ratios are \<1.05.|Ratio of geometric means (%)|88.2|||||TWO_SIDED|90.0|81.03|96.02|||||Comparison of Bricanyl Turbuhaler M3 (test) to Bricanyl Turbuhaler M2 (reference)|No increase in the exposure of plasma terbutaline after administration of Bricanyl Turbuhaler M3 will be concluded if the upper bound of the 90% CIs for the ratios of AUC and Cmax are both below 1.25||96.02|81.03|
72326962|NCT03723980|144177530|OTHER|||||||0.15||||||"The p-value calculated is for pain score difference at 4 hours~Threshold for statistical significance= \<0.05"|Kruskal-Wallis|||||||0.15
72326963|NCT03723980|144177530|OTHER|||||||0.36||||||"The p-value calculated is for pain score difference at 12 hours~Threshold for statistical significance= \<0.05"|Kruskal-Wallis|||||||0.36
72326964|NCT03723980|144177530|OTHER|||||||0.13||||||"The p-value calculated is for pain score difference at day 2~Threshold for statistical significance= \<0.05"|Kruskal-Wallis|||||||0.13
72326965|NCT03723980|144177530|OTHER|||||||0.55||||||"The p-value calculated is for pain score difference at day 3~Threshold for statistical significance= \<0.05"|Kruskal-Wallis|||||||0.55
72326966|NCT03723980|144177530|OTHER|||||||0.17||||||"The p-value calculated is for pain score difference at day 4~Threshold for statistical significance= \<0.05"|Kruskal-Wallis|||||||0.17
72326967|NCT04512001|144177535|EQUIVALENCE|Margins for results to be considered equivalent: -0.6 to 0.5.|Least squares means difference|0.01|||||TWO_SIDED|90.0|-0.16|0.18||||||||0.18|-0.16|
72326968|NCT04512001|144177537|EQUIVALENCE|Margins for results to be considered equivalent: -15%, 15%.|Difference in % Response Rate|-3.94|||||TWO_SIDED|95.0|-9.97|2.11||||||||2.11|-9.97|
72326969|NCT03198767|144177547|SUPERIORITY||Ratio of number of events|0.71||||0.202|TWO_SIDED|80.0|0.5|1.0|||Mixed Models Analysis|||Day 3||1.00|0.50|0.202
72326970|NCT03198767|144177547|SUPERIORITY||Ratio of number of events|0.21|||<|0.001|TWO_SIDED|80.0|0.14|0.32|||Mixed Models Analysis|||Day 3||0.32|0.14|<0.001
72326971|NCT03198767|144177547|SUPERIORITY||Ratio of number of events|0.3|||<|0.001|TWO_SIDED|80.0|0.19|0.46|||Mixed Models Analysis|||Day 3||0.46|0.19|<0.001
72326972|NCT03198767|144177547|SUPERIORITY||Ratio of number of events|0.79||||0.275|TWO_SIDED|80.0|0.6|1.04|||Mixed Models Analysis|||Day 3||1.04|0.60|0.275
72326973|NCT03198767|144177547|SUPERIORITY||Ratio of number of events|0.78||||0.234|TWO_SIDED|80.0|0.59|1.02|||Mixed Models Analysis|||Day 3||1.02|0.59|0.234
72612964|NCT01311661|144754497|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.296|STANDARD_ERROR_OF_MEAN|0.053|<|0.0001||95.0|-0.4|-0.192|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo|||-0.192|-0.400|<0.0001
72612965|NCT01311661|144754497|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.301|STANDARD_ERROR_OF_MEAN|0.053|<|0.0001||95.0|-0.405|-0.198|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg bid minus Placebo|||-0.198|-0.405|<0.0001
72612966|NCT01311661|144754497|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.302|STANDARD_ERROR_OF_MEAN|0.053|<|0.0001||95.0|-0.405|-0.198|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo|||-0.198|-0.405|<0.0001
72612967|NCT00207740|144754499|SUPERIORITY_OR_OTHER|||||||0.802||||||When interpreting this p-value along with the other co-primary endpoint, Hochberg procedure was used.|ANCOVA|||The null hypothesis was that the endpoint for placebo is the same as that for combined 100 mg and 200 mg golimumab. Assuming a standard deviation of 23%, there is 86% power to detect a 10% difference at a 0.05 significance level.||||0.802
72612968|NCT00207740|144754499|SUPERIORITY_OR_OTHER|||||||0.945||||||The nominal p-value is for descriptive purpose only.|ANCOVA|||This is a secondary analysis.||||0.945
72612969|NCT00207740|144754499|SUPERIORITY_OR_OTHER|||||||0.717||||||The nominal p-value is for descriptive purpose only.|ANCOVA|||This is a secondary analysis.||||0.717
72612970|NCT00207740|144754499|SUPERIORITY_OR_OTHER|||||||0.357||||||The nominal p-value is for descriptive purpose only.|ANCOVA|||This is a secondary analysis.||||0.357
72612971|NCT00207740|144754500|SUPERIORITY_OR_OTHER|||||||0.286|||||||Wilcoxon (Mann-Whitney)|||The null hypothesis was that the endpoint for placebo is the same as that in the combined 100 mg and 200 mg golimumab.||||0.286
72612972|NCT00207740|144754500|SUPERIORITY_OR_OTHER|||||||0.742|||||||Wilcoxon (Mann-Whitney)|||||||0.742
72612973|NCT00207740|144754500|SUPERIORITY_OR_OTHER|||||||0.128|||||||Wilcoxon (Mann-Whitney)|||||||0.128
72612974|NCT00207740|144754500|SUPERIORITY_OR_OTHER|||||||0.946|||||||Wilcoxon (Mann-Whitney)|||||||0.946
72612975|NCT00207740|144754501|SUPERIORITY_OR_OTHER|||||||0.718||||||When interpreting this p-value along with the other co-primary endpoint, Hochberg procedure was used.|Cochran-Mantel-Haenszel|||The null hypothesis was that the number of severe exacerbations per patient from baseline through week 24 for placebo is the same as that in the combined 100 mg and 200 mg golimumab. Assuming 1 severe exacerbation over 6 months per patient in the placebo group, there is 79% power to detect a 35% reduction in the combined 100 mg and 200 mg golimumab group at a 0.05 significance level.||||0.718
72612976|NCT00207740|144754501|SUPERIORITY_OR_OTHER|||||||0.779||||||The nominal p-value is for descriptive purpose only.|Cochran-Mantel-Haenszel|||This is a secondary analysis.||||0.779
72612977|NCT00207740|144754501|SUPERIORITY_OR_OTHER|||||||0.649||||||The nominal p-value is for descriptive purpose only.|Cochran-Mantel-Haenszel|||This is a secondary analysis.||||0.649
72612978|NCT00207740|144754501|SUPERIORITY_OR_OTHER|||||||0.256||||||The nominal p-value is for descriptive purpose only.|Cochran-Mantel-Haenszel|||This is a secondary analysis.||||0.256
72612979|NCT00207740|144754502|SUPERIORITY_OR_OTHER|||||||0.894|||||||Kruskal-Wallis|||The null hypothesis was that the endpoint for placebo is the same as that in the combined 100 mg and 200 mg golimumab.||||0.894
72612980|NCT00207740|144754502|SUPERIORITY_OR_OTHER|||||||0.572|||||||Kruskal-Wallis|||||||0.572
72612981|NCT00207740|144754502|SUPERIORITY_OR_OTHER|||||||0.731|||||||Kruskal-Wallis|||||||0.731
72612982|NCT00207740|144754502|SUPERIORITY_OR_OTHER|||||||0.856|||||||Kruskal-Wallis|||||||0.856
72612983|NCT00207740|144754503|SUPERIORITY_OR_OTHER|||||||0.273|||||||Cochran-Mantel-Haenszel|||The null hypothesis was that the endpoint for placebo is the same as that in the combined 100 mg and 200 mg golimumab.||||0.273
72612984|NCT00207740|144754503|SUPERIORITY_OR_OTHER|||||||0.382|||||||Cochran-Mantel-Haenszel|||||||0.382
72612985|NCT00207740|144754503|SUPERIORITY_OR_OTHER|||||||0.35|||||||Cochran-Mantel-Haenszel|||||||0.350
72612986|NCT00207740|144754503|SUPERIORITY_OR_OTHER|||||||0.341|||||||Cochran-Mantel-Haenszel|||||||0.341
72612987|NCT00207740|144754504|SUPERIORITY_OR_OTHER|||||||0.986|||||||Wilcoxon (Mann-Whitney)|||The null hypothesis was that the endpoint for placebo is the same as that in the combined 100 mg and 200 mg golimumab.||||0.986
72612988|NCT00207740|144754504|SUPERIORITY_OR_OTHER|||||||0.82|||||||Wilcoxon (Mann-Whitney)|||||||0.820
72612989|NCT00207740|144754504|SUPERIORITY_OR_OTHER|||||||0.858|||||||Wilcoxon (Mann-Whitney)|||||||0.858
72612990|NCT00207740|144754504|SUPERIORITY_OR_OTHER|||||||0.021|||||||Wilcoxon (Mann-Whitney)|||||||0.021
72612991|NCT00207740|144754505|SUPERIORITY_OR_OTHER|||||||0.833||95.0|||||ANOVA|||The null hypothesis was that the endpoint for placebo is the same as that in the combined 100 mg and 200 mg golimumab.||||0.833
72612992|NCT00207740|144754505|SUPERIORITY_OR_OTHER|||||||0.814||95.0|||||ANOVA|||||||0.814
72612993|NCT00207740|144754505|SUPERIORITY_OR_OTHER|||||||0.897||95.0|||||ANOVA|||||||0.897
72612994|NCT00207740|144754505|SUPERIORITY_OR_OTHER|||||||0.726||95.0|||||ANOVA|||||||0.726
72612995|NCT01155570|144754551|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||comparison versus Baseline at Week 4||||<0.0001
72612996|NCT01155570|144754552|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||comparison versus Baseline at Week 8||||<0.0001
72612997|NCT01155570|144754553|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||comparison versus Baseline at Week 16||||<0.0001
72612998|NCT01155570|144754554|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||comparison versus Baseline at Week 24||||<0.0001
72612999|NCT01155570|144754555|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||comparison versus Baseline at Week 16||||<0.0001
72613000|NCT01155570|144754556|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||comparison versus Baseline at Week 24||||<0.0001
72613001|NCT01155570|144754561|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||comparison versus Baseline at Week 16||||<0.0001
72419448|NCT02178059|144349394|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.8052|TWO_SIDED|90.0|-0.17|0.17|||Wilcoxon signed rank test|||||0.17|-0.17|0.8052
72613002|NCT01155570|144754562|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||comparison versus Baseline at Week 24||||<0.0001
72613003|NCT01155570|144754563|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||comparison versus Baseline at Week 4||||<0.0001
72613004|NCT01155570|144754564|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||comparison versus Baseline at Week 16||||<0.0001
72613005|NCT01155570|144754566|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||comparison versus Baseline at Week 24||||<0.0001
72613006|NCT01155570|144754567|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||comparison versus Baseline at Week 4||||<0.0001
72613007|NCT01155570|144754568|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||comparison versus Baseline at Week 16||||<0.0001
72613008|NCT01155570|144754569|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||comparison versus Baseline at Week 24||||<0.0001
72613009|NCT01155570|144754570|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||comparison versus Baseline at Week 4||||<0.0001
72613010|NCT01155570|144754571|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||comparison versus Baseline at Week 16||||<0.0001
72613011|NCT01155570|144754572|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||comparison versus Baseline at Week 24||||<0.0001
72613012|NCT00296517|144754573|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.2||||0.805||95.0|-1.6|2.0|||ANOVA|||Null Hypothesis: The population mean change from baseline on HAM-D total score at Week 12 of the placebo group is equal to the population mean change from baseline on HAMD total score at Week 12 of the Bupropion hydrochloride sustained release group.||2.0|-1.6|0.805
72613013|NCT00296517|144754583|SUPERIORITY_OR_OTHER_LEGACY|||||||0.036|||||||Log Rank|||||||0.036
72613014|NCT03513952|144754591|SUPERIORITY|||||||0.428||||||A one-sided significance level of 0.10 will be considered for the test.|Cochran-Mantel-Haenszel||||Estimations were done separately in each treatment arm; the difference between treatments was not calculated.|||0.428
72613015|NCT03513952|144754592|EQUIVALENCE|"Two-sided Cochran-Mantel-Haenszel test for the CBR was performed, which is used for testing zero effect or equivalence between treatments. A two-sided significance level of 0.05 will be considered for the test."|Risk Difference (RD)|-6.0||||0.702|TWO_SIDED|95.0|-36.3|24.3|||Cochran-Mantel-Haenszel|||||24.3|-36.3|0.702
72613016|NCT01143324|144754599|SUPERIORITY_OR_OTHER||Mean|1.3|STANDARD_DEVIATION|0.5|||TWO_SIDED|95.0|1.2|1.3||||||||1.3|1.2|
72613017|NCT01143324|144754600|SUPERIORITY_OR_OTHER||Difference from pre-op mean|-3.3|||<|0.0001|TWO_SIDED|95.0|-3.6|-2.9|||t-test, 2 sided|||||-2.9|-3.6|<0.0001
72613018|NCT01143324|144754601|SUPERIORITY_OR_OTHER||Difference from pre-op mean|-3.8|||<|0.0001|TWO_SIDED|95.0|-4.2|-3.3|||t-test, 2 sided|||||-3.3|-4.2|<0.0001
72613019|NCT01143324|144754602|SUPERIORITY_OR_OTHER||Difference from pre-op mean|0.35|||<|0.0001|TWO_SIDED|95.0|0.3|0.41|||t-test, 2 sided|||||0.41|0.30|<0.0001
72613020|NCT01143324|144754604|SUPERIORITY_OR_OTHER||Percentage|27.0|||||||||||||61/226 patients underwent a rehabilitation programs between 6 and 12 months follow up visit, making it 27.0 % of the total.|||||
72613021|NCT01143324|144754605|SUPERIORITY_OR_OTHER||Percentage|1.2|||||||||||||The rate of additional lumbar spinal surgeries at treated level was 1.2% (3/252) patients.|||||
72613022|NCT01143324|144754606|SUPERIORITY_OR_OTHER||Percentage|1.6|||||||||||||The rate of additional lumbar spinal surgeries at the same level was 1.6% (4/252) patients.|||||
72613023|NCT01143324|144754607|SUPERIORITY_OR_OTHER||Percentage at 12 months|47.6||||||||||||||||||
72613024|NCT01143324|144754609|SUPERIORITY_OR_OTHER||Difference from pre-op mean|-23.0|||<|0.0001|TWO_SIDED|95.0|-25.5|-20.5|||t-test, 2 sided|||||-20.5|-25.5|<0.0001
72613025|NCT01143324|144754610|SUPERIORITY_OR_OTHER||Percentage|42.7||||||||||||||||||
72613026|NCT01143324|144754611|SUPERIORITY_OR_OTHER||Mean|3.2|STANDARD_DEVIATION|2.0||||95.0|2.9|3.4||||||||3.4|2.9|
72613027|NCT02774889|144754623|SUPERIORITY||Rate Ratio|0.72||||0.55|TWO_SIDED|95.0|0.27|2.57|||Fisher Exact|||||2.57|0.27|0.55
72613028|NCT02774889|144754624|SUPERIORITY||Mean Difference (Final Values)|-4.74||||0.001|TWO_SIDED|95.0|-6.61|-2.89|||Fisher Exact|||at 3 months||-2.89|-6.61|0.001
72613029|NCT02774889|144754624|SUPERIORITY||Mean Difference (Final Values)|-4.07||||0.001|TWO_SIDED|95.0|-6.47|-1.68|||Fisher Exact|||at 6 months||-1.68|-6.47|0.001
72613030|NCT02774889|144754625|SUPERIORITY||Mean Difference (Final Values)|0.08||||0.05|TWO_SIDED|95.0|0.0|0.16|||Fisher Exact|||3 months||0.16|0.00|0.05
72613031|NCT02774889|144754625|SUPERIORITY||Mean Difference (Final Values)|0.15||||0.0003|TWO_SIDED|95.0|0.07|0.22|||Fisher Exact|||6 months||0.22|0.07|0.0003
72613032|NCT02774889|144754626|SUPERIORITY||Mean Difference (Final Values)|0.03||||0.88|TWO_SIDED|95.0|-0.4|0.44|||Fisher Exact|||3 months||0.44|-0.40|0.88
72613033|NCT02774889|144754626|SUPERIORITY||Mean Difference (Final Values)|-0.05||||0.83|TWO_SIDED|95.0|-0.48|0.37|||Fisher Exact|||6 months||0.37|-0.48|0.83
72613034|NCT02774889|144754627|SUPERIORITY||Mean Difference (Final Values)|0.17||||0.36|TWO_SIDED|95.0|-0.2|0.54|||Fisher Exact|||3 months||0.54|-0.20|0.36
72613035|NCT02774889|144754627|SUPERIORITY||Mean Difference (Final Values)|0.33||||0.14|TWO_SIDED|95.0|-0.11|0.77|||Fisher Exact|||6 months||0.77|-0.11|0.14
72613036|NCT02774889|144754628|SUPERIORITY||Mean Difference (Final Values)|0.21||||0.52|TWO_SIDED|95.0|-0.43|0.85|||Fisher Exact|||3 months||0.85|-0.43|0.52
72613037|NCT02774889|144754628|SUPERIORITY||Mean Difference (Final Values)|0.27||||0.36|TWO_SIDED|95.0|-0.31|0.85|||Fisher Exact|||6 months||0.85|-0.31|0.36
72613038|NCT02774889|144754629|SUPERIORITY||Mean Difference (Final Values)|0.38||||0.43|TWO_SIDED|95.0|-0.58|1.32|||Fisher Exact|||3 months||1.32|-0.58|0.43
72613039|NCT02774889|144754629|SUPERIORITY||Mean Difference (Final Values)|0.54||||0.26|TWO_SIDED|95.0|-0.42|1.49|||Fisher Exact|||6 months||1.49|-0.42|0.26
72613040|NCT02774889|144754630|SUPERIORITY||Mean Difference (Final Values)|0.25||||0.16|TWO_SIDED|95.0|-0.09|0.61|||Fisher Exact|||3 months||0.61|-0.09|0.16
72613041|NCT02774889|144754630|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.29|TWO_SIDED|95.0|-0.55|0.17|||Fisher Exact|||6 months||0.17|-0.55|0.29
72613042|NCT02774889|144754632|SUPERIORITY||Mean Difference (Final Values)|-0.14||||0.91|TWO_SIDED|95.0|-2.66|2.4|||Fisher Exact|||3 months||2.40|-2.66|0.91
72613043|NCT02774889|144754632|SUPERIORITY||Mean Difference (Final Values)|-0.33||||0.8|TWO_SIDED|95.0|-2.79|2.15|||Fisher Exact|||6 months||2.15|-2.79|0.80
72613044|NCT02774889|144754633|SUPERIORITY||Mean Difference (Final Values)|0.63||||0.54|TWO_SIDED|95.0|-1.44|2.64|||Fisher Exact|||3 months||2.64|-1.44|0.54
72613045|NCT02774889|144754633|SUPERIORITY||Mean Difference (Final Values)|1.18||||0.38|TWO_SIDED|95.0|-1.49|3.81|||Fisher Exact|||6 months||3.81|-1.49|0.38
72613046|NCT02774889|144754635|SUPERIORITY||Mean Difference (Final Values)|1.89||||0.04|TWO_SIDED|95.0|0.06|3.71|||Fisher Exact|||Inside Balance||3.71|0.06|0.04
72613047|NCT02774889|144754635|SUPERIORITY||Mean Difference (Final Values)|1.75||||0.05|TWO_SIDED|95.0|-0.02|3.51|||Fisher Exact|||Outside Balance||3.51|-0.02|0.05
72613048|NCT02774889|144754635|SUPERIORITY||Mean Difference (Final Values)|1.86||||0.06|TWO_SIDED|95.0|-0.08|3.81|||Fisher Exact|||Strength||3.81|-0.08|0.06
72613049|NCT02774889|144754636|SUPERIORITY||Mean Difference (Final Values)|1.63||||0.003|TWO_SIDED|95.0|0.54|2.17|||Fisher Exact|||Balance Exercises at 3 months||2.17|0.54|0.003
72613050|NCT02774889|144754636|SUPERIORITY||Mean Difference (Final Values)|1.01||||0.11|TWO_SIDED|95.0|-0.22|2.24|||Fisher Exact|||Balance Exercises at 6 Months||2.24|-0.22|0.11
72326974|NCT03198767|144177547|SUPERIORITY||Ratio of number of events|0.98||||0.921|TWO_SIDED|80.0|0.73|1.3|||Mixed Models Analysis|||Day 3||1.30|0.73|0.921
72613051|NCT02774889|144754637|SUPERIORITY||Mean Difference (Final Values)|1.06||||0.01|TWO_SIDED|95.0|0.23|1.89|||Fisher Exact|||Strength Exercises at 3 months||1.89|0.23|0.01
72613052|NCT02774889|144754637|SUPERIORITY||Mean Difference (Final Values)|0.75||||0.11|TWO_SIDED|95.0|-0.16|1.67|||Fisher Exact|||Strength Exercises at 6 months||1.67|-0.16|0.11
72613053|NCT02774889|144754638|SUPERIORITY||Mean Difference (Final Values)|1.02||||0.38|TWO_SIDED|95.0|-1.3|3.3|||Fisher Exact|||3 months||3.30|-1.30|0.38
72613054|NCT02774889|144754638|SUPERIORITY||Mean Difference (Final Values)|2.6||||0.02|TWO_SIDED|95.0|0.43|4.73|||Fisher Exact|||6 months||4.73|0.43|0.02
72613055|NCT02774889|144754639|SUPERIORITY||Mean Difference (Final Values)|0.32||||0.33|TWO_SIDED|95.0|-0.33|0.97|||Fisher Exact|||3 months||0.97|-0.33|0.33
72613056|NCT02774889|144754639|SUPERIORITY||Mean Difference (Final Values)|0.63||||0.06|TWO_SIDED|95.0|-0.02|1.27|||Fisher Exact|||6 months||1.27|-0.02|0.06
72613057|NCT02774889|144754640|SUPERIORITY||Mean Difference (Final Values)|0.62||||0.06|TWO_SIDED|95.0|-0.03|1.28|||Fisher Exact|||3 months||1.28|-0.03|0.06
72613058|NCT02774889|144754640|SUPERIORITY||Mean Difference (Final Values)|0.18||||0.59|TWO_SIDED|95.0|-0.45|0.81|||Fisher Exact|||||0.81|-0.45|0.59
72613059|NCT04901624|144754673|SUPERIORITY||Slope|1.19|STANDARD_ERROR_OF_MEAN|0.4||0.003|TWO_SIDED|95.0|0.42|1.97|||Mixed Models Analysis||Coefficient for mixed effects regression comparing Time 2 attendance to Time 1 attendance for Personal + Loss Protection relative to reference group (Personal + Lottery).|||1.97|0.42|0.003
72613060|NCT04901624|144754673|SUPERIORITY||Slope|1.46|STANDARD_ERROR_OF_MEAN|0.4|<|0.001|TWO_SIDED|95.0|0.68|2.24|||Mixed Models Analysis||Coefficient for mixed effects regression comparing Time 2 attendance to Time 1 attendance for Family + Loss Protection relative to reference group (Personal + Lottery).|||2.24|0.68|<0.001
72613061|NCT04901624|144754673|SUPERIORITY||Slope|1.11|STANDARD_ERROR_OF_MEAN|0.44||0.01|TWO_SIDED|95.0|0.26|1.96|||Mixed Models Analysis||Coefficient for mixed effects regression comparing Time 2 attendance to Time 1 attendance for Family + Lottery relative to reference group (Personal + Lottery).|||1.96|0.26|0.01
72613062|NCT04901624|144754674|SUPERIORITY||Slope|-0.29|STANDARD_ERROR_OF_MEAN|0.35||0.409|TWO_SIDED|95.0|-0.98|0.4|||Regression, Logistic|||Comparison of Time 2 attendance between study arms among respondents who indicated that money was the biggest barrier to getting the vaccine.||0.4|-0.98|0.409
72613063|NCT04901624|144754674|SUPERIORITY||Slope|0.5|STANDARD_ERROR_OF_MEAN|0.3||0.098|TWO_SIDED|95.0|-0.09|1.1|||Regression, Logistic|||Comparison of Time 2 attendance between study arms among respondents who indicated that money was the biggest barrier to getting the vaccine.||1.10|-0.09|0.098
72613064|NCT04901624|144754674|SUPERIORITY||Slope|0.01|STANDARD_ERROR_OF_MEAN|0.37||0.982|TWO_SIDED|95.0|-0.71|0.73|||Regression, Logistic|||Comparison of Time 2 attendance between study arms among respondents who indicated that money was the biggest barrier to getting the vaccine.||0.73|-0.71|0.982
72613065|NCT04901624|144754674|SUPERIORITY||Slope|-0.27|STANDARD_ERROR_OF_MEAN|0.2||0.177|TWO_SIDED|95.0|-0.67|0.12|||Regression, Logistic|||Comparison of Time 2 attendance between study arms among respondents who indicated that their medical provider was the most trusted source of COVID-19 information.||0.12|-0.67|0.177
72326975|NCT03198767|144177548|SUPERIORITY||Ratio of number of events|0.68||||0.04|TWO_SIDED|80.0|0.54|0.86|||Mixed Models Analysis|||||0.86|0.54|0.040
72326976|NCT03198767|144177548|SUPERIORITY||Ratio of number of events|0.37|||<|0.001|TWO_SIDED|80.0|0.28|0.49|||Mixed Models Analysis|||||0.49|0.28|<0.001
72326977|NCT03198767|144177548|SUPERIORITY||Ratio of number of events|0.54||||0.008|TWO_SIDED|80.0|0.41|0.72|||Mixed Models Analysis|||||0.72|0.41|0.008
72326978|NCT03198767|144177548|SUPERIORITY||Ratio of number of events|0.79||||0.141|TWO_SIDED|80.0|0.65|0.97|||Mixed Models Analysis|||||0.97|0.65|0.141
72613066|NCT04901624|144754674|SUPERIORITY||Slope|0.33|STANDARD_ERROR_OF_MEAN|0.21||0.117|TWO_SIDED|95.0|-0.08|0.74|||Regression, Logistic|||Comparison of Time 2 attendance between study arms among respondents who indicated that their medical provider was the most trusted source of COVID-19 information.||0.74|-0.08|0.117
72613067|NCT04901624|144754674|SUPERIORITY||Slope|0.05|STANDARD_ERROR_OF_MEAN|0.23||0.809|TWO_SIDED|95.0|-0.39|0.5|||Regression, Logistic|||Comparison of Time 2 attendance between study arms among respondents who indicated that their medical provider was the most trusted source of COVID-19 information.||0.50|-0.39|0.809
72613068|NCT04901624|144754674|SUPERIORITY||Slope|0.04|STANDARD_ERROR_OF_MEAN|0.19||0.847|TWO_SIDED|95.0|-0.34|0.41|||Regression, Logistic|||Comparison of Time 2 attendance between study arms among respondents who scored below or equal to 5 on the risk aversion scale (scale of 0-10, with 0 being more risk averse and 10 being more risk prone).||0.41|-0.34|0.847
72613069|NCT04901624|144754674|SUPERIORITY||Slope|-0.002|STANDARD_ERROR_OF_MEAN|0.2||0.993|TWO_SIDED|95.0|-0.39|0.38|||Regression, Logistic|||Comparison of Time 2 attendance between study arms among respondents who scored below or equal to 5 on the risk aversion scale (scale of 0-10, with 0 being more risk averse and 10 being more risk prone).||0.38|-0.39|0.993
72613070|NCT04901624|144754674|SUPERIORITY||Slope|-0.09|STANDARD_ERROR_OF_MEAN|0.22||0.671|TWO_SIDED|95.0|-0.51|0.33|||Regression, Logistic|||Comparison of Time 2 attendance between study arms among respondents who scored below or equal to 5 on the risk aversion scale (scale of 0-10, with 0 being more risk averse and 10 being more risk prone).||0.33|-0.51|0.671
72613071|NCT03100747|144754675|SUPERIORITY||Odds Ratio (OR)|1.21||||0.039|TWO_SIDED|98.3|0.97|1.52||The a priori threshold for statistical significance (adjusted for multiple comparisons) is 0.0167.|Regression, Logistic|||||1.52|0.97|0.039
72613072|NCT03100747|144754675|SUPERIORITY||Odds Ratio (OR)|1.91|||<|0.0001|TWO_SIDED|98.3|1.54|2.36||The a priori threshold for statistical significance (adjusted for multiple comparisons) is 0.0167.|Regression, Logistic|||||2.36|1.54|<0.0001
72613073|NCT03100747|144754675|SUPERIORITY||Odds Ratio (OR)|1.57|||<|0.0001|TWO_SIDED|98.3|1.29|1.92||The a priori threshold for statistical significance (adjusted for multiple comparisons) is 0.0167.|Regression, Logistic|||||1.92|1.29|<0.0001
72613074|NCT03100747|144754680|SUPERIORITY||Odds Ratio (OR)|0.84||||0.094|TWO_SIDED|98.3|0.65|1.08||p-values adjusted for multiple comparisons|Regression, Logistic|||||1.08|0.65|0.094
72613075|NCT03100747|144754680|SUPERIORITY||Odds Ratio (OR)|0.5|||<|0.0001|TWO_SIDED|98.3|0.38|0.67||p-value adjusted for multiple comparisons, the a priori threshold for statistical significance (adjusted for multiple comparisons) is 0.0167.|Regression, Logistic|||||0.67|0.38|<0.0001
72613076|NCT03100747|144754680|SUPERIORITY||Odds Ratio (OR)|0.6|||<|0.0001|TWO_SIDED|98.3|0.45|0.8||The a priori threshold for statistical significance (adjusted for multiple comparisons) is 0.0167.|Regression, Logistic|||||0.80|0.45|<0.0001
72613077|NCT03100747|144754685|SUPERIORITY||Odds Ratio (OR)|0.86||||0.24|TWO_SIDED|98.3|0.64|1.17|||Regression, Logistic|||||1.17|0.64|0.24
72613078|NCT03100747|144754685|SUPERIORITY||Odds Ratio (OR)|0.68||||0.0037|TWO_SIDED|98.3|0.49|0.93|||Regression, Logistic|||||0.93|0.49|0.0037
72613079|NCT03100747|144754685|SUPERIORITY||Odds Ratio (OR)|0.78||||0.08|TWO_SIDED|98.3|0.57|1.09|||Regression, Logistic|||||1.09|0.57|0.08
72613080|NCT05399485|144754721|SUPERIORITY||[Difference in Least square (LS) Mean]|-1.1||||0.0021|TWO_SIDED|95.0|-1.73|-0.38|||Mixed Models Analysis|||Linear mixed effects model with repeated measures with number of total migraine days per month in the OP as a covariate, treatment group, randomization stratum (stable prophylactic migraine medication use throughout randomization), month, and month-by treatment group interaction as fixed effects.||-0.38|-1.73|0.0021
72613081|NCT05399485|144754722|SUPERIORITY||Difference in Percentage|7.3||||0.0989|TWO_SIDED|95.0|-1.4|15.9||P-value \>0.05; therefore, all secondary outcome measures listed after this outcome measure in the hierarchy were not tested.|Mantel Haenszel|||The percentages of participants with reductions were compared between treatment groups using Mantel-Haenszel risk estimation with stratification by randomization stratum (stable prophylactic migraine medication use throughout randomization; yes, no).||15.9|-1.4|0.0989
72613082|NCT00770809|144754774|SUPERIORITY_OR_OTHER_LEGACY|||||||0.13|TWO_SIDED|||||Participants were stratified by clinical stage (II vs III) and hormone receptor status (positive/negative).|Log Rank|||||||0.13
72613083|NCT00770809|144754774|SUPERIORITY_OR_OTHER_LEGACY|||||||0.072|TWO_SIDED|||||Participants were stratified by clinical stage (II vs III) and hormone receptor status (positive/negative).|Log Rank|||||||0.072
72613084|NCT06023563|144754791|OTHER|The required sample size for medium effect size (f = 0.25) and power of 0.80 was calculated to be 6 participants in each group (n =12) (G\*power 3.1.9.7 software). Data were analyzed using IBM SPSS statistical package (version 29.0.1.0).|||||<|0.05|||||||Friedman's test|||A virtual reality active video gaming intervention will be more effective than traditional physical therapy based balance exercises, both based on motor learning principles, in improving static and dynamic balance in youth and young adults with ASD and these improvements will be retained at 4 weeks after the intervention.||||< 0.05
72613085|NCT06023563|144754792|OTHER||||||<|0.05|||||||Friedman's test|||||||< 0.05
72613086|NCT06023563|144754793|OTHER||||||<|0.05|||||||Friedman's test|||||||< 0.05
72613087|NCT06023563|144754794|OTHER||||||<|0.05|||||||Friedman's test|||||||< 0.05
72613088|NCT06023563|144754795|OTHER||||||<|0.05|||||||Friedman's test|||||||< 0.05
72613089|NCT06023563|144754796|OTHER||||||<|0.05|||||||Friedman's test|||||||< 0.05
72613090|NCT06023563|144754797|OTHER||||||<|0.05|||||||Friedman's test|||||||< 0.05
72613091|NCT06023563|144754798|OTHER||||||<|0.05|||||||Friedman's test|||||||< 0.05
72613092|NCT03474107|144754799|SUPERIORITY||Stratified Hazard Ratio|0.702||||0.00142|TWO_SIDED|95.0|0.556|0.886||Stratification factors were ECOG PS, geographic region and liver metastasis. P-value was based on log-rank test. P-value of overall survival is ≤ the predetermined 1-sided significance level of 0.00679 based on the number of observed deaths.|Stratified Log rank||Cox proportional hazards model with treatment, ECOG PS, geographic region and liver metastasis as the explanatory variables.|||0.886|0.556|0.00142
72613093|NCT03474107|144754800|SUPERIORITY||Stratified Hazard Ratio|0.615|||<|1e-05|TWO_SIDED|95.0|0.505|0.748||Stratification factors were ECOG PS, geographic region and liver metastasis. P-value was based on log-rank test. P value of PFS is ≤ the predetermined 1-sided significance level of 0.02189 based on the number of observed PFS events.|Stratified Log Rank||Cox proportional hazards model with treatment, ECOG PS, geographic region and liver metastasis as the explanatory variables.|||0.748|0.505|<0.00001
72613094|NCT03474107|144754801|SUPERIORITY||||||<|0.001||||||"Stratification factors were ECOG PS, Region and Liver Metastasis."|Stratified Cochran-Mantel-Haenszel|||||||<0.001
72613095|NCT03474107|144754802|SUPERIORITY||||||<|0.001||||||Stratification factors were ECOG PS, Region and Liver Metastasis.|Stratified Cochran-Mantel-Haenszel|||||||<0.001
72613096|NCT00055237|144754813|SUPERIORITY_OR_OTHER||proportion estimate,binomial exact 95%CI|31.0|STANDARD_DEVIATION|11.6|||TWO_SIDED|95.0|11.0|58.7|||sample estimate with 95% CI||As stated in the Outcome statistical Analysis 1. Section, the confidence interval was calculated using binomial exact statistics. The standard deviation is based on that calculation.|||58.7|11|
72613097|NCT02127671|144754815|SUPERIORITY||Mean Difference (Net)|-12.7|||||TWO_SIDED|95.0|-22.9|-2.5||||||||-2.5|-22.9|
72613098|NCT02127671|144754817|SUPERIORITY||Mean Difference (Net)|0.1|||||TWO_SIDED|95.0|-0.7|0.9||||||||0.9|-0.7|
72613099|NCT02127671|144754821|SUPERIORITY||Mean Difference (Net)|-7.6|||||TWO_SIDED|95.0|-17.6|2.4||||||||2.4|-17.6|
72613100|NCT02127671|144754822|SUPERIORITY||Mean Difference (Net)|0.0|||||TWO_SIDED|95.0|-0.3|0.2||||||||0.2|-0.3|
72613101|NCT02127671|144754823|SUPERIORITY||Mean Difference (Net)|-10.5|||||TWO_SIDED|95.0|-18.4|-2.6||||||||-2.6|-18.4|
72613102|NCT02127671|144754824|SUPERIORITY||Mean Difference (Net)|-1.8|||||TWO_SIDED|95.0|-5.1|1.5||||||systolic||1.5|-5.1|
72613103|NCT02127671|144754824|SUPERIORITY||Mean Difference (Net)|-1.7|||||TWO_SIDED|95.0|-3.8|0.5||||||diastolic||0.5|-3.8|
72613104|NCT02127671|144754826|SUPERIORITY||Mean Difference (Net)|-4.3|||||TWO_SIDED|95.0|-13.3|4.7||||||||4.7|-13.3|
72613105|NCT02127671|144754827|SUPERIORITY||Mean Difference (Net)|-5.4|||||TWO_SIDED|95.0|-12.7|2.0||||||||2.0|-12.7|
72613106|NCT02127671|144754828|SUPERIORITY||Mean Difference (Net)|1.0|||||TWO_SIDED|95.0|-1.8|3.8||||||||3.8|-1.8|
72613107|NCT02127671|144754829|SUPERIORITY||Mean Difference (Net)|8.1|||||TWO_SIDED|95.0|-13.4|29.6||||||||29.6|-13.4|
72613108|NCT03834168|144754837|OTHER|||||||0.003|||||||Regression (Cosinor Fit)|||||||0.003
72613109|NCT03834168|144754837|SUPERIORITY||||||<|0.001|||||||Regression, Linear|||||||<0.001
72613110|NCT03556683|144754840|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||Effect immediately following hypertonic saline treatment.||||<0.001
72613111|NCT03556683|144754841|SUPERIORITY|||||||0.99|||||||Mixed Models Analysis|||Effect of hypertonic saline 4 hours after treatment.||||0.99
72613112|NCT04757636|144754843|SUPERIORITY||Least Squares Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|1.03||0.861409|TWO_SIDED|95.0|-2.2|1.84|||MMRM|||||1.84|-2.20|0.861409
72613113|NCT04757636|144754843|SUPERIORITY||Least Squares Mean Difference|-0.84|STANDARD_ERROR_OF_MEAN|1.029||0.416264|TWO_SIDED|95.0|-2.86|1.18|||MMRM|||||1.18|-2.86|0.416264
72613114|NCT04757636|144754844|SUPERIORITY||Risk Difference (RD)|0.1||||0.981348|TWO_SIDED|95.0|-7.5|7.7|||Mantel Haenszel||The rate/rate differences are estimated and compared by aggregating the MH estimates adjusted for the Baseline BCVA category and baseline lesion type read by independent reading center on each of the 100 multiple imputed datasets using Rubin's rule.|||7.7|-7.5|0.981348
72613115|NCT04757636|144754844|SUPERIORITY||Risk Difference (RD)|-0.7||||0.856|TWO_SIDED|95.0|-8.5|7.0|||Mantel Haenszel||The rate/rate differences are estimated and compared by aggregating the MH estimates adjusted for the Baseline BCVA category and baseline lesion type read by independent reading center on each of the 100 multiple imputed datasets using Rubin's rule.|||7.0|-8.5|0.856000
72613116|NCT04757636|144754845|SUPERIORITY||Risk Difference (RD)|-1.7||||0.655104|TWO_SIDED|95.0|-8.9|5.6|||Mantel Haenszel||The rate/rate differences are estimated and compared by aggregating the MH estimates adjusted for the Baseline BCVA category and baseline lesion type read by independent reading center on each of the 100 multiple imputed datasets using Rubin's rule.|||5.6|-8.9|0.655104
72613117|NCT04757636|144754845|SUPERIORITY||Risk Difference (RD)|-0.8||||0.821257|TWO_SIDED|95.0|-8.2|6.5|||Mantel Haenszel||The rate/rate differences are estimated and compared by aggregating the MH estimates adjusted for the Baseline BCVA category and baseline lesion type read by independent reading center on each of the 100 multiple imputed datasets using Rubin's rule.|||6.5|-8.2|0.821257
72613118|NCT04757636|144754846|SUPERIORITY||Least Squares Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.234||0.199828|TWO_SIDED|95.0|-0.76|0.16|||MMRM|||||0.16|-0.76|0.199828
72613119|NCT04757636|144754846|SUPERIORITY||Least Squares Mean Difference|-0.31|STANDARD_ERROR_OF_MEAN|0.235||0.188725|TWO_SIDED|95.0|-0.77|0.15|||MMRM|||||0.15|-0.77|0.188725
72613120|NCT04757636|144754847|SUPERIORITY||Risk Difference (RD)|-0.5||||0.84781|TWO_SIDED|95.0|-5.6|4.6|||Mantel Haenszel||The rate/rate differences are estimated and compared by aggregating the MH estimates adjusted for the Baseline BCVA category and baseline lesion type read by independent reading center on each of the 100 multiple imputed datasets using Rubin's rule.|||4.6|-5.6|0.847810
72326979|NCT03198767|144177548|SUPERIORITY||Ratio of number of events|0.9||||0.51|TWO_SIDED|80.0|0.74|1.1|||Mixed Models Analysis|||||1.10|0.74|0.510
72326980|NCT03198767|144177548|SUPERIORITY||Ratio of number of events|1.14||||0.401|TWO_SIDED|80.0|0.93|1.41|||Mixed Models Analysis|||||1.41|0.93|0.401
72613121|NCT04757636|144754847|SUPERIORITY||Risk Difference (RD)|0.9||||0.718699|TWO_SIDED|95.0|-4.2|6.1|||Mantel Haenszel||The rate/rate differences are estimated and compared by aggregating the MH estimates adjusted for the Baseline BCVA category and baseline lesion type read by independent reading center on each of the 100 multiple imputed datasets using Rubin's rule.|||6.1|-4.2|0.718699
72613122|NCT01433913|144754854|OTHER|||||||0.23|||||||Wilcoxon (Mann-Whitney)|||||||0.23
72613123|NCT01433913|144754855|OTHER||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||||||<0.01
72613124|NCT01433913|144754856|OTHER|||||||0.77|||||||Wilcoxon (Mann-Whitney)|||||||0.77
72613125|NCT01433913|144754857|OTHER|||||||0.09|||||||Wilcoxon (Mann-Whitney)|||||||0.09
72613126|NCT01433913|144754858|OTHER|||||||0.72|||||||Wilcoxon (Mann-Whitney)|||||||0.72
72613127|NCT01433913|144754862|OTHER|||||||0.63|||||||Wilcoxon (Mann-Whitney)|||||||0.63
72613128|NCT01433913|144754863|OTHER|||||||0.25|||||||Wilcoxon (Mann-Whitney)|||||||0.25
72613129|NCT01433913|144754864|OTHER|||||||0.46|||||||Wilcoxon (Mann-Whitney)|||||||0.46
72613130|NCT01433913|144754865|OTHER|||||||0.46|||||||Wilcoxon (Mann-Whitney)|||||||0.46
72613131|NCT01433913|144754866|OTHER|||||||0.36|||||||Wilcoxon (Mann-Whitney)|||||||0.36
72613132|NCT00770367|144754890|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence.|Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.05||0.37|TWO_SIDED||||||t-test, 2 sided|||A twosample comparison of mean treatment differences conducted using a pre-determined significance level of alpha level \<0.05. 2 a comparison of means for NOx levels at 12 weeks b/w groups. 3 on the change F2-isoprostanes at 12 weeks b/w groups.||||.37
72326981|NCT03198767|144177549|SUPERIORITY||Mean Difference (Final Values)|-0.21||||0.426|TWO_SIDED|80.0|-0.56|0.13|||Mixed Models Analysis|||||0.13|-0.56|0.426
72326982|NCT03198767|144177549|SUPERIORITY||Median Difference (Final Values)|-1.06||||0.001|TWO_SIDED|80.0|-1.46|-0.67|||Mixed Models Analysis|||||-0.67|-1.46|0.001
72613133|NCT00920816|144754892|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.767|||||TWO_SIDED|95.0|0.559|1.053||||||First-line participants: hazard ratio was stratified by eastern cooperative oncology group (ECOG) performance status (0 versus 1).||1.053|0.559|
72613134|NCT00920816|144754893|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.731|||||TWO_SIDED|95.0|0.506|1.058||||||Second-line participants: hazard ratio was stratified by eastern cooperative oncology group (ECOG) performance status (0 versus 1) and prior treatment (sunitinib versus cytokine-containing regimen).||1.058|0.506|
72613135|NCT01900314|144754955|SUPERIORITY_OR_OTHER|||||||0.16|||||||ANCOVA|||Repeated measures ANCOVA at 4 weeks with baseline MADRS as co-variate||||0.16
72613136|NCT01900314|144754956|SUPERIORITY_OR_OTHER|||||||0.04|||||||ANCOVA|||Repeated measures ANCOVA with baseline MADRS as co-variate||||0.04
72613137|NCT01104766|144754957|SUPERIORITY||Mean Difference (Final Values)|-6.0||||0.0044|TWO_SIDED|95.0|-10.1|-1.9|||ANCOVA|||||-1.9|-10.1|0.0044
72613138|NCT01104766|144754957|SUPERIORITY||Mean Difference (Final Values)|-8.8|||<|0.0001|TWO_SIDED|95.0|-12.9|-4.7|||ANCOVA|||||-4.7|-12.9|<0.0001
72613139|NCT01104766|144754957|SUPERIORITY||Median Difference (Final Values)|-7.0||||0.0008|TWO_SIDED|95.0|-11.0|-2.9|||ANCOVA|||||-2.9|-11.0|0.0008
72613140|NCT01104766|144754958|SUPERIORITY||Mean Difference (Final Values)|-0.4||||0.0004|TWO_SIDED|95.0|-0.6|-0.2|||ANCOVA|||||-0.2|-0.6|0.0004
72613141|NCT01104766|144754958|SUPERIORITY||Median Difference (Final Values)|-0.5|||<|0.0001|TWO_SIDED|95.0|-0.7|-0.3|||ANCOVA|||||-0.3|-0.7|<0.0001
72613142|NCT01104766|144754958|SUPERIORITY||Median Difference (Final Values)|-0.4||||0.0001|TWO_SIDED|95.0|-0.6|-0.2|||ANCOVA|||||-0.2|-0.6|0.0001
72613143|NCT04225832|144754963|SUPERIORITY||Odds Ratio (OR)|2.51||||0.049|TWO_SIDED|95.0|1.01|6.26||a-priori threshold was p\<.05 for two-sided p-value Regression employed nonresponse weights to account for any bias associated with completing any follow-up survey.|Regression, Logistic|Regression results control for immigration status and length of time in U.S.|Odds ratio is for indicator of intervention arm||Regression results control for immigration status and length of time in U.S.|6.26|1.01|.049
72613144|NCT04225832|144754964|SUPERIORITY||Odds Ratio (OR)|1.06||||0.83|TWO_SIDED|95.0|0.62|1.81||a-priori threshold was p\<.05 for two-sided p-value Regression employed nonresponse weights to account for any bias associated with completing any follow-up survey.|Regression, Logistic|Regression results control for immigration status and length of time in U.S.|Odds ratio is for indicator of intervention arm|||1.81|0.62|.83
72613145|NCT04225832|144754965|SUPERIORITY||Slope|0.14|STANDARD_ERROR_OF_MEAN|0.09||0.14|TWO_SIDED|||||a-priori threshold was p\<.05 for two-sided p-value Regression employed nonresponse weights to account for any bias associated with completing any follow-up survey.|Regression, Linear|Regression results control for immigration status, length of time in U.S., and baseline value of the outcome|Slope is adjusted regression coefficient for indicator of intervention arm|"Unlike the observed at any FU primary outcomes which have a single value for each participant, for this outcome we employed a repeated measures style structure with one record for each of up to 3 FU observations. A sandwich estimator (SAS Proc Surveyreg) was employed to account for clustering of observations within participant."||||.14
72613146|NCT03282097|144754981|SUPERIORITY|||||||0.4393|||||||ANCOVA|||||||0.4393
72613147|NCT03282097|144754982|SUPERIORITY|||||||0.2262|||||||ANCOVA|||||||.2262
72613148|NCT03282097|144754983|SUPERIORITY|||||||0.0023|||||||ANCOVA|||||||0.0023
72613149|NCT03282097|144754984|SUPERIORITY|||||||0.6075|||||||Regression, Logistic|||||||0.6075
72613150|NCT03282097|144754985|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<.0001
72613151|NCT03282097|144754986|SUPERIORITY||||||<|0.0001|||||||Regression, Logistic|||||||<0.0001
72613152|NCT06001021|144755008|SUPERIORITY|"In the Superiority Trial, the statistical test aims to show that the treatment group gives better results than the control group. In an equivalence trial, the statistical test aims to show that two treatments are not too different in characteristics, where not too different is defined in a clinical manner (Lesaffre, 2008).~Lesaffre E. Superiority, equivalence, and non-inferiority trials. Bull NYU Hosp Jt Dis. 2008;66(2):150-4. PMID: 18537788."|Mean Difference (Final Values)|-35.55|STANDARD_DEVIATION|17.78||0|TWO_SIDED|90.0|-38.9|-32.19||The significance level is 0.10 with 90% confidence interval|ANCOVA|||||-32.19|-38.90|0.000
72419449|NCT02178059|144349398|NON_INFERIORITY_OR_EQUIVALENCE|Approximately 34 healthy volunteers will be entered into the study in order to complete 30 evaluable volunteers. Based on the study SD-001-0268, a residual intra-individual standard deviation of 0.300/sqrt(2) = 0.212 can be expected on the natural log scale. With 30 completed volunteers there will be a 93% chance that the upper limits of two-sided 90% CI for Cmax and AUC ratios are \<1.25 provided that the true mean ratios are \<1.05.|Ratio of geometric means (%)|91.44|||||TWO_SIDED|90.0|84.82|98.58|||||Comparison of Bricanyl Turbuhaler M3 (test) to Bricanyl Turbuhaler M2 (reference)|No increase in the exposure of plasma terbutaline after administration of Bricanyl Turbuhaler M3 will be concluded if the upper bound of the 90% CIs for the ratios of AUC and Cmax are both below 1.25||98.58|84.82|
72419450|NCT00662857|144349416|SUPERIORITY_OR_OTHER||Ratio of Geometric Means|0.982|||||TWO_SIDED|90.0|0.846|1.141|||||"Geometric Mean Ratio of serum insulin from a single 30 U cartridge to 2 x 15 U cartridges of TI.~Based on pair-wise comparisons from analysis of covariance fitting the model: natural log of parameter = cohort, treatment, visit, subject (cohort)."|||1.141|0.846|
72419451|NCT00662857|144349417|SUPERIORITY_OR_OTHER||Ratio of Geometric Means|0.951|||||TWO_SIDED|90.0|0.823|1.099|||||"Geometric Mean Ratio of serum insulin from a single 30 U cartridge to 2 x 15 U cartridges of TI.~Based on pair-wise comparisons from analysis of covariance fitting the model: natural log of parameter = cohort, treatment, visit, subject (cohort)."|||1.099|0.823|
72419452|NCT00662857|144349418|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.3531|||||||Signed Rank Test|||||||0.3531
72419453|NCT00662857|144349419|SUPERIORITY_OR_OTHER||Ratio of Geometric Means|0.46|||||TWO_SIDED|90.0|0.366|0.578|||||"Geometric Mean Ratio of serum insulin from a single 30 U cartridge of TI to 10 U sc insulin lispro.~Based on pair-wise comparisons from analysis of covariance fitting the model: natural log of parameter = cohort, treatment, visit, subject (cohort)."|||0.578|0.366|
72419454|NCT00990964|144349435|SUPERIORITY_OR_OTHER||One sample proportion|0.94|||||TWO_SIDED|95.0|0.929|0.951||||||||.951|.929|
72419455|NCT00990964|144349436|SUPERIORITY_OR_OTHER||One sample proportion|0.974|||||TWO_SIDED|95.0|0.965|0.98||||||||.980|.965|
72419456|NCT00514943|144349444|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.49||||0.7606|TWO_SIDED|95.0|-11.188|8.202||P-value obtained from fitting an ANCOVA model including treatment, stratification factor prior chemotherapy for recurrent/metastatic disease and the baseline sum of longest distance of target lesions.|ANCOVA|Receipt of prior chemotherapy for recurrent/metastatic disease and the baseline sum of longest distance for target lesions are covariates|Mean difference calculated is actually the adjusted mean difference.|||8.202|-11.188|0.7606
72419457|NCT00514943|144349457|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.942||||0.764|TWO_SIDED|95.0|0.64|1.387|||Regression, Cox||Hazard ratio, 95% CI and p-value are calculated from the Cox proportional hazards model stratified by the number of prior chemotherapies for R/M setting (0 or \>=1)|||1.387|0.640|0.764
72419458|NCT00514943|144349458|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.725||||0.219|TWO_SIDED|95.0|0.434|1.212|||Regression, Cox||Hazard ratio, 95% CI and p-value are calculated from the Cox proportional hazards model stratified by the number of prior chemotherapies for R/M setting (0 or \>=1)|||1.212|0.434|0.219
72419459|NCT00514943|144349459|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.067||||0.758|TWO_SIDED|95.0|0.708|1.608|||Regression, Cox||Hazard ratio, 95% CI and p-value are calculated from the Cox proportional hazards model stratified by the number of prior chemotherapies for R/M setting (0 or \>=1)|||1.608|0.708|0.758
72419460|NCT02563002|144349511|OTHER||Hazard Ratio (HR)|0.59||||0.0001|TWO_SIDED|95.0|0.45|0.79|||Log Rank|One-sided p-value based on log rank test|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate.|||0.79|0.45|0.0001
72613153|NCT06001021|144755009|SUPERIORITY|"In the Superiority Trial, the statistical test aims to show that the treatment group gives better results than the control group. In an equivalence trial, the statistical test aims to show that two treatments are not too different in characteristics, where not too different is defined in a clinical manner (Lesaffre, 2008). Lesaffre E. Superiority, equivalence, and non-inferiority trials. Bull NYU Hosp Jt Dis.~2008;66(2):150-4. PMID: 18537788"|Mean Difference (Final Values)|23.96|STANDARD_DEVIATION|23.14||0|TWO_SIDED|90.0|19.59|28.32||The significance level is 0.10 with 90% confidence interval|ANCOVA|||||28.32|19.59|0.000
72419461|NCT02563002|144349512|OTHER||Hazard Ratio (HR)|0.74||||0.0359|TWO_SIDED|95.0|0.53|1.03|||Log Rank|One-sided p-value based on log rank test|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate.|||1.03|0.53|0.0359
72419462|NCT02563002|144349513|OTHER||Difference in percentage|12.0||||0.0159|TWO_SIDED|95.0|1.0|22.6||One-sided p-value based on Miettinen \& Nurminen method.|Miettinen & Nurminen method||Based on Miettinen \& Nurminen method.|||22.6|1.0|0.0159
72419463|NCT01113502|144349532|OTHER||Maximum Tolerated Dose (mg)|300.0|||||TWO_SIDED|||||||||||||
72419464|NCT00995501|144349538|SUPERIORITY||Odds Ratio (OR)|0.96||||0.86|TWO_SIDED|99.6|0.45|2.0|||Regression, Logistic|||Compare 4 arms with intensive glucose control vs. 4 arms with conventional glucose control||2|0.45|0.86
72419465|NCT00995501|144349538|SUPERIORITY||Odds Ratio (OR)|0.96||||0.87|TWO_SIDED|99.6|0.45|2.0|||Regression, Logistic|||Compare 4 arms with Dexamethasone vs. 4 arms with Placebo||2|0.45|0.87
72419466|NCT00995501|144349538|SUPERIORITY||Odds Ratio (OR)|1.0||||0.9|TWO_SIDED|99.6|0.49|2.2|||Regression, Logistic|||Compare 4 arms with light anesthesia vs. 4 arms with deep anesthesia||2.2|0.49|0.90
72419467|NCT00995501|144349539|SUPERIORITY||Odds Ratio (OR)|0.92||||0.8|TWO_SIDED|99.6|0.37|2.3|||Regression, Logistic|||Compare 4 arms with intensive glucose control vs. 4 arms with conventional glucose control||2.3|0.37|0.8
72419468|NCT00995501|144349539|SUPERIORITY||Odds Ratio (OR)|1.1||||0.84|TWO_SIDED|99.6|0.43|2.7|||Regression, Logistic|||Compare 4 arms with Dexamethasone vs. 4 arms with Placebo||2.7|0.43|0.84
72419469|NCT00995501|144349539|SUPERIORITY||Odds Ratio (OR)|1.1||||0.87|TWO_SIDED|99.6|0.42|2.7|||Regression, Logistic|||||2.7|0.42|0.87
72419470|NCT01058304|144349712|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.67||||0.1024|TWO_SIDED|95.0|-5.87|0.538|||Mixed Models Analysis|||"The analysis compares study Arm 1 and Arm 2 at 24-week follow-up, with 12-week data also included in the response trajectory.~The hypothesis being tested is that group-based PT (Arm 1) will result in a significantly greater improvement WOMAC scores compared to individual PT (Arm 2)"||0.538|-5.87|0.1024
72613154|NCT06001021|144755010|SUPERIORITY|"In the Superiority Trial, the statistical test aims to show that the treatment group gives better results than the control group. In an equivalence trial, the statistical test aims to show that two treatments are not too different in characteristics, where not too different is defined in a clinical manner (Lesaffre, 2008).~Lesaffre E. Superiority, equivalence, and non-inferiority trials. Bull NYU Hosp Jt Dis. 2008;66(2):150-4. PMID: 18537788."|Mean Difference (Final Values)|86.89|STANDARD_DEVIATION|45.43||0|TWO_SIDED|90.0|78.33|95.46||The significance level is 0.10 with 90% confidence interval|ANCOVA|||||95.46|78.33|0.00
72613155|NCT06001021|144755011|SUPERIORITY|"In the Superiority Trial, the statistical test aims to show that the treatment group gives better results than the control group. In an equivalence trial, the statistical test aims to show that two treatments are not too different in characteristics, where not too different is defined in a clinical manner (Lesaffre, 2008).~Lesaffre E. Superiority, equivalence, and non-inferiority trials. Bull NYU Hosp Jt Dis. 2008;66(2):150-4. PMID: 18537788."|Mean Difference (Final Values)|22.26|STANDARD_DEVIATION|15.15||0|TWO_SIDED|90.0|19.41|25.12||The significance level is 0.10 with 90% confidence interval|ANCOVA|||||25.12|19.41|0.000
72613156|NCT06001021|144755012|SUPERIORITY|"In the Superiority Trial, the statistical test aims to show that the treatment group gives better results than the control group. In an equivalence trial, the statistical test aims to show that two treatments are not too different in characteristics, where not too different is defined in a clinical manner (Lesaffre, 2008)."|Mean Difference (Final Values)|16.44|STANDARD_DEVIATION|7.55||0|TWO_SIDED|90.0|15.02|17.87||The significance level is 0.10 with 90% confidence interval|ANCOVA|||Physical Domain of Quality of Life||17.87|15.02|0.000
72613157|NCT06001021|144755012|SUPERIORITY|"In the Superiority Trial, the statistical test aims to show that the treatment group gives better results than the control group. In an equivalence trial, the statistical test aims to show that two treatments are not too different in characteristics, where not too different is defined in a clinical manner (Lesaffre, 2008)."|Mean Difference (Final Values)|16.6|STANDARD_DEVIATION|7.62||0|TWO_SIDED|90.0|15.16|18.04||The significance level is 0.10 with 90% confidence interval.|ANCOVA|||Psychological Domain of Quality of Life||18.04|15.16|0.000
72613158|NCT06001021|144755012|SUPERIORITY|"In the Superiority Trial, the statistical test aims to show that the treatment group gives better results than the control group. In an equivalence trial, the statistical test aims to show that two treatments are not too different in characteristics, where not too different is defined in a clinical manner (Lesaffre, 2008)."|Mean Difference (Final Values)|8.26|STANDARD_DEVIATION|3.96||0|TWO_SIDED|90.0|7.52|9.01||The significance level is 0.10 with 90% confidence interval.|ANCOVA|||Social Domain of Quality of Life||9.01|7.52|0.000
72613159|NCT06001021|144755012|SUPERIORITY|"In the Superiority Trial, the statistical test aims to show that the treatment group gives better results than the control group. In an equivalence trial, the statistical test aims to show that two treatments are not too different in characteristics, where not too different is defined in a clinical manner (Lesaffre, 2008)."|Mean Difference (Final Values)|23.73|STANDARD_DEVIATION|11.07||0|TWO_SIDED|90.0|21.64|25.81||The significance level is 0.10 with 90% confidence interval.|ANCOVA|||||25.81|21.64|0.000
72613160|NCT05473039|144755033|SUPERIORITY|||||||0.2629|||||||Wilcoxon (Mann-Whitney)|||||||0.2629
72613161|NCT05473039|144755034|SUPERIORITY|||||||0.3582|||||||Wilcoxon (Mann-Whitney)|||||||0.3582
72613162|NCT05473039|144755035|SUPERIORITY|||||||0.2187|||||||Wilcoxon (Mann-Whitney)|||||||0.2187
72613163|NCT05473039|144755036|SUPERIORITY|||||||0.3005|||||||Wilcoxon (Mann-Whitney)|||||||0.3005
72613164|NCT05473039|144755037|SUPERIORITY|||||||0.0314|||||||Wilcoxon (Mann-Whitney)|||||||0.0314
72613165|NCT05473039|144755038|SUPERIORITY|||||||0.9214|||||||t-test, 2 sided|||||||0.9214
72613166|NCT05473039|144755038|SUPERIORITY|||||||0.042|||||||t-test, 2 sided|||Fasting glucose at the start of COH compared to baseline fasting glucose.||||0.042
72613167|NCT05473039|144755038|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||Fasting glucose at the start of COH compared to baseline fasting glucose.||||<0.001
72613168|NCT05473039|144755039|SUPERIORITY|||||||0.59695|||||||t-test, 2 sided|||||||0.59695
72613169|NCT05473039|144755039|SUPERIORITY|||||||0.466503|||||||t-test, 2 sided|||AST at the start of COH compared to baseline AST.||||0.466503
72613170|NCT05473039|144755039|SUPERIORITY|||||||0.959877|||||||t-test, 2 sided|||AST at the start of COH compared to baseline AST.||||0.959877
72613171|NCT05473039|144755040|SUPERIORITY|||||||0.06281|||||||t-test, 2 sided|||||||0.062810
72613172|NCT05473039|144755040|SUPERIORITY|||||||0.417757|||||||t-test, 2 sided|||ALT at the start of COH compared to baseline ALT.||||0.417757
72613173|NCT05473039|144755040|SUPERIORITY|||||||0.968525|||||||t-test, 2 sided|||ALT at the start of COH compared to baseline ALT.||||0.968525
72613174|NCT05473039|144755041|SUPERIORITY|||||||0.686488|||||||t-test, 2 sided|||||||0.686488
72613175|NCT05473039|144755041|SUPERIORITY|||||||0.39512|||||||t-test, 2 sided|||Cholesterol at the start of COH compared to baseline cholesterol.||||0.395120
72613176|NCT05473039|144755041|SUPERIORITY|||||||0.127135|||||||t-test, 2 sided|||Cholesterol at the start of COH compared to baseline cholesterol.||||0.127135
72613177|NCT05473039|144755042|SUPERIORITY|||||||0.257496|||||||t-test, 2 sided|||||||0.257496
72613178|NCT02535312|144755047|OTHER|||||||0.08|||||||Log Rank|||||||0.08
72613179|NCT02535312|144755048|OTHER|||||||0.15|||||||Log Rank|||||||0.15
72613180|NCT03034967|144755071|OTHER|Emax|Median Posterior Difference|0.08|||||TWO_SIDED|90.0|0.0|0.66|||||Median posterior difference, 90 percent (%) credible interval for Placebo and Danirixin 5 mg has been presented.|4-parameter Emax model selected.||0.66|0.00|
72613181|NCT03034967|144755071|OTHER|Emax|Median Posterior Difference|0.61|||||TWO_SIDED|90.0|0.0|1.52|||||Median posterior difference, 90% credible interval for Placebo and Danirixin 10 mg has been presented.|4-parameter Emax model||1.52|0.00|
72613182|NCT03034967|144755071|OTHER|Emax|Median Posterior Difference|1.25|||||TWO_SIDED|90.0|0.43|1.97|||||Median posterior difference, 90% credible interval for Placebo and Danirixin 25 mg has been presented.|4-parameter Emax model selected.||1.97|0.43|
72613183|NCT03034967|144755071|OTHER|Emax|Median Posterior Difference|1.34|||||TWO_SIDED|90.0|0.72|2.03|||||Median posterior difference, 90% credible interval for Placebo and Danirixin 35 mg has been presented.|4-parameter Emax model selected.||2.03|0.72|
72613184|NCT03034967|144755071|OTHER|Emax|Median Posterior Difference|1.38|||||TWO_SIDED|90.0|0.79|2.07|||||Median posterior difference, 90% credible interval for Placebo and Danirixin 50 mg has been presented.|4-parameter Emax model selected.||2.07|0.79|
72613185|NCT03034967|144755072|OTHER|Emax|Median Posterior Difference|0.09|||||TWO_SIDED|90.0|0.0|0.42|||||Median posterior difference, 90% credible interval for Placebo and Danirixin 5 mg has been presented.|4-parameter Emax model selected.||0.42|0.00|
72613186|NCT03034967|144755072|OTHER|Emax|Median Posterior Difference|0.43|||||TWO_SIDED|90.0|0.0|0.87|||||Median posterior difference, 90% credible interval for Placebo and Danirixin 10 mg has been presented.|4-parameter Emax model||0.87|0.00|
72613187|NCT03034967|144755072|OTHER|Emax|Median Posterior Difference|0.68|||||TWO_SIDED|90.0|0.23|1.08|||||Median posterior difference, 90% credible interval for Placebo and Danirixin 25 mg has been presented.|4-parameter Emax model selected.||1.08|0.23|
72613188|NCT03034967|144755072|OTHER|Emax|Median Posterior Difference|0.72|||||TWO_SIDED|90.0|0.37|1.1|||||Median posterior difference, 90% credible interval for Placebo and Danirixin 35 mg has been presented.|4-parameter Emax model selected.||1.10|0.37|
72613189|NCT03034967|144755072|OTHER|Emax|Median Posterior Difference|0.73|||||TWO_SIDED|90.0|0.4|1.12|||||Median posterior difference, 90% credible interval for Placebo and Danirixin 50 mg has been presented.|4-parameter Emax model selected.||1.12|0.40|
72613190|NCT03034967|144755073|OTHER|Emax|Median Posterior Difference|0.01|||||TWO_SIDED|90.0|0.0|0.16|||||Median posterior difference, 90% credible interval for Placebo and Danirixin 5 mg has been presented.|4-parameter Emax model selected.||0.16|0.00|
72613191|NCT03034967|144755073|OTHER|Emax|Median Posterior Difference|0.12|||||TWO_SIDED|90.0|0.0|0.43|||||Median posterior difference, 90% credible interval for Placebo and Danirixin 10 mg has been presented.|4-parameter Emax model||0.43|0.00|
72613192|NCT03034967|144755073|OTHER|Emax|Median Posterior Difference|0.38|||||TWO_SIDED|90.0|0.04|0.61|||||Median posterior difference, 90% credible interval for Placebo and Danirixin 25 mg has been presented.|4-parameter Emax model selected.||0.61|0.04|
72613193|NCT03034967|144755073|OTHER|Emax|Median Posterior Difference|0.42|||||TWO_SIDED|90.0|0.21|0.64|||||Median posterior difference, 90% credible interval for Placebo and Danirixin 35 mg has been presented.|4-parameter Emax model selected.||0.64|0.21|
72613194|NCT03034967|144755073|OTHER|Emax|Median Posterior Difference|0.45|||||TWO_SIDED|90.0|0.26|0.66|||||Median posterior difference, 90% credible interval for Placebo and Danirixin 50 mg has been presented.|4-parameter Emax model selected.||0.66|0.26|
72613195|NCT03034967|144755074|OTHER|Log-linear|Median Posterior Difference|0.01|||||TWO_SIDED|90.0|-0.21|0.23|||||Median posterior difference, 90% credible interval for Placebo and Danirixin 5 mg has been presented.|Log-linear model.||0.23|-0.21|
72613196|NCT03034967|144755074|OTHER|Log-linear|Median Posterior Difference|0.01|||||TWO_SIDED|90.0|-0.23|0.25|||||Median posterior difference, 90% credible interval for Placebo and Danirixin 10 mg has been presented.|Log-linear model||0.25|-0.23|
72613197|NCT03034967|144755074|OTHER|Log-linear|Median Posterior Difference|0.01|||||TWO_SIDED|90.0|-0.27|0.29|||||Median posterior difference, 90% credible interval for Placebo and Danirixin 25 mg has been presented.|Log-linear model||0.29|-0.27|
72613198|NCT03034967|144755074|OTHER|Log-linear|Median Posterior Difference|0.01|||||TWO_SIDED|90.0|-0.28|0.3|||||Median posterior difference, 90% credible interval for Placebo and Danirixin 35 mg has been presented.|Log-linear model||0.30|-0.28|
72613199|NCT03034967|144755074|OTHER|Log-linear|Median Posterior Difference|0.01|||||TWO_SIDED|90.0|-0.29|0.31|||||Median posterior difference, 90% credible interval for Placebo and Danirixin 50 mg has been presented.|Log-linear model||0.31|-0.29|
72613200|NCT03034967|144755081|OTHER||Odds Ratio (OR)|1.71||||0.089|TWO_SIDED|90.0|1.02|2.86||Analysis performed using a generalized linear mixed model with a logit link function including treatment, relevant Baseline E-RS: COPD score, smoking status at Screening, country, month, Baseline by month and treatment by month interactions.|linear mixed model||Odds Ratio, 90% credible interval for Placebo and Danirixin 5 mg has been presented.|||2.86|1.02|0.089
72613201|NCT03034967|144755081|OTHER||Odds Ratio (OR)|1.05||||0.881|TWO_SIDED|90.0|0.62|1.79||Analysis performed using a generalized linear mixed model with a logit link function including treatment, relevant Baseline E-RS: COPD score, smoking status at Screening, country, month, Baseline by month and treatment by month interactions.|linear mixed model||Odds Ratio, 90% credible interval for Placebo and Danirixin 10 mg has been presented.|||1.79|0.62|0.881
72613202|NCT03034967|144755081|OTHER||Odds Ratio (OR)|0.87||||0.674|TWO_SIDED|90.0|0.51|1.48||Analysis performed using a generalized linear mixed model with a logit link function including treatment, relevant Baseline E-RS: COPD score, smoking status at Screening, country, month, Baseline by month and treatment by month interactions.|linear mixed model||Odds Ratio, 90% credible interval for Placebo and Danirixin 25 mg has been presented.|||1.48|0.51|0.674
72613203|NCT03034967|144755081|OTHER||Odds Ratio (OR)|0.92||||0.804|TWO_SIDED|90.0|0.54|1.58||Analysis performed using a generalized linear mixed model with a logit link function including treatment, relevant Baseline E-RS: COPD score, smoking status at Screening, country, month, Baseline by month and treatment by month interactions.|linear mixed model||Odds Ratio, 90% credible interval for Placebo and Danirixin 35 mg has been presented.|||1.58|0.54|0.804
72613204|NCT03034967|144755081|OTHER||Odds Ratio (OR)|1.01||||0.987|TWO_SIDED|90.0|0.59|1.71||Analysis performed using a generalized linear mixed model with a logit link function including treatment, relevant Baseline E-RS: COPD score, smoking status at Screening, country, month, Baseline by month and treatment by month interactions.|linear mixed model||Odds Ratio, 90% credible interval for Placebo and Danirixin 50 mg has been presented.|||1.71|0.59|0.987
72613205|NCT03034967|144755083|OTHER||Median Posterior Hazard Ratio|1.2|||||TWO_SIDED|90.0|0.5|2.6|||||Median Posterior Hazard Ratio, 90% credible interval for Placebo and Danirixin 5 mg has been presented.||DNX versus (vs.) Placebo statistics calculated using a Bayesian proportional hazards model including treatment, gender, exacerbation history (\<=1/\>=2 moderate/severe), smoking status at Screening, country and post-bronchodilator % predicted Forced Expiratory Volume in one second (FEV1)at Screening.|2.6|0.5|
72326983|NCT03198767|144177549|SUPERIORITY||Mean Difference (Final Values)|-0.85||||0.009|TWO_SIDED|80.0|-1.25|-0.45|||Mixed Models Analysis|||||-0.45|-1.25|0.009
72419471|NCT01058304|144349712|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.3||||0.444|TWO_SIDED|95.0|-4.64|2.04|||Mixed Models Analysis|||The hypothesis being tested is that the group-based PT program (Arm 1) will result in greater improvements in WOMAC scores at 24-week follow-up (12 weeks after the end of the group program) when compared to usual PT care (Arm 2).||2.04|-4.64|0.444
72419472|NCT01058304|144349713|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.113||||0.527|TWO_SIDED|95.0|-0.463|0.238|||Mixed Models Analysis|||The analysis compares Arms 1 and 2 at 12-week follow-up. The hypothesis being tested is that the group-based PT program (Arm 1) will result in a significantly greater improvement in SPPB scores compared with the individual PT program (Arm 2).||0.238|-0.463|0.527
72419473|NCT02755597|144349715|SUPERIORITY||Hazard Ratio (HR)|0.656|||=|0.012|TWO_SIDED|95.0|0.471|0.913|||Log Rank||Hazard ratio was estimated by Cox proportional hazards model|Stratified Analysis; Stratification factors: Prior exposure to proteasome inhibitors (naïve versus sensitive), and number of prior lines of therapy (1 versus 2 or 3)||0.913|0.471|=0.012
72419474|NCT02755597|144349716|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|||Stratified Analysis; Stratification factors: Prior exposure to proteasome inhibitors (naïve versus sensitive), and number of prior lines of therapy (1 versus 2 or 3)||||<0.001
72419475|NCT02755597|144349718|SUPERIORITY||Hazard Ratio (HR)|0.508|||<|0.001|TWO_SIDED|95.0|0.343|0.753|||Log Rank||Hazard ratio was estimated by Cox proportional hazards model|Stratified Analysis; Stratification factors: Prior exposure to proteasome inhibitors (naïve versus sensitive), and number of prior lines of therapy (1 versus 2 or 3)||0.753|0.343|<0.001
72419476|NCT02755597|144349723|SUPERIORITY||Hazard Ratio (HR)|1.191|||=|0.385|TWO_SIDED|95.0|0.802|1.77|||Log Rank||Hazard ratio was estimated by Cox proportional hazards model|Stratified Analysis; Stratification factors: Prior exposure to proteasome inhibitors (naïve versus sensitive), and number of prior lines of therapy (1 versus 2 or 3)||1.770|0.802|=0.385
72613206|NCT03034967|144755083|OTHER||Median Posterior Hazard Ratio|1.0|||||TWO_SIDED|90.0|0.4|2.4|||||Median Posterior Hazard Ratio, 90% credible interval for Placebo and Danirixin 10 mg has been presented.||DNX vs. Placebo statistics calculated using a Bayesian proportional hazards model including treatment, gender, exacerbation history (\<=1/\>=2 moderate/severe), smoking status at Screening, country and post-bronchodilator % predicted FEV1 at Screening.|2.4|0.4|
72613207|NCT03034967|144755083|OTHER||Median Posterior Hazard Ratio|1.4|||||TWO_SIDED|90.0|0.6|3.2|||||Median Posterior Hazard Ratio, 90% credible interval for Placebo and Danirixin 25 mg has been presented.||DNX vs. Placebo statistics calculated using a Bayesian proportional hazards model including treatment, gender, exacerbation history (\<=1/\>=2 moderate/severe), smoking status at Screening, country and post-bronchodilator % predicted FEV1 at Screening.|3.2|0.6|
72419477|NCT02755597|144349724|SUPERIORITY||Hazard Ratio (HR)|0.571|||=|0.001|TWO_SIDED|95.0|0.405|0.805|||Log Rank||Hazard ratio was estimated by Cox proportional hazards model|Stratified Analysis; Stratification factors: Prior exposure to proteasome inhibitors (naïve versus sensitive), and number of prior lines of therapy (1 versus 2 or 3)||0.805|0.405|=0.001
72419478|NCT02755597|144349725|SUPERIORITY||||||=|0.019|||||||Cochran-Mantel-Haenszel|||Stratified Analysis; Stratification factors: Prior exposure to proteasome inhibitors (naïve versus sensitive), and number of prior lines of therapy (1 versus 2 or 3)||||=0.019
72419479|NCT02755597|144349726|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|||Stratified Analysis; Stratification factors: Prior exposure to proteasome inhibitors (naïve versus sensitive), and number of prior lines of therapy (1 versus 2 or 3)||||<0.001
72419480|NCT01069354|144349727|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.41|||<|0.0001|TWO_SIDED|||||Paired t-test|t-test, 2 sided|||||||<0.0001
72419481|NCT01069354|144349728|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Binomial proportion, two-sided Fisher's exact test|Fisher Exact|||91 (90.1%) of 101 subjects had a ≥ 2.0 cm lower VAS Score in treatment versus control NLF at Time 0||||<0.0001
72326984|NCT03198767|144177549|SUPERIORITY||Mean Difference (Final Values)|-0.37||||0.135|TWO_SIDED|80.0|-0.68|-0.05|||Mixed Models Analysis|||||-0.05|-0.68|0.135
72326985|NCT03198767|144177549|SUPERIORITY||Median Difference (Final Values)|-0.19||||0.436|TWO_SIDED|80.0|-0.5|0.12|||Mixed Models Analysis|||||0.12|-0.50|0.436
72326986|NCT03198767|144177549|SUPERIORITY||Median Difference (Final Values)|0.18||||0.452|TWO_SIDED|80.0|-0.13|0.49|||Mixed Models Analysis|||||0.49|-0.13|0.452
72326987|NCT00570323|144177552|SUPERIORITY|||||||0.6202|||||||t-test, 2 sided|||||||0.6202
72419482|NCT01069354|144349729|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Paired t-test|t-test, 2 sided|||||||<0.0001
72419483|NCT01069354|144349730|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Paired t-test|t-test, 2 sided|||||||<0.0001
72419484|NCT01069354|144349731|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Paired t-test|t-test, 2 sided|||||||<0.0001
72419485|NCT01069354|144349732|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Paired t-test|t-test, 2 sided|||||||<0.0001
72419486|NCT01069354|144349733|SUPERIORITY_OR_OTHER|||||||0.5663||||||Paired t-test|t-test, 2 sided|||||||0.5663
72419487|NCT01069354|144349734|SUPERIORITY_OR_OTHER|||||||0.3197||||||Paired t-test|t-test, 2 sided|||||||0.3197
72613208|NCT03034967|144755083|OTHER||Median Posterior Hazard Ratio|2.0|||||TWO_SIDED|90.0|1.0|4.3|||||Median Posterior Hazard Ratio, 90% credible interval for Placebo and Danirixin 35 mg has been presented.||DNX vs. Placebo statistics calculated using a Bayesian proportional hazards model including treatment, gender, exacerbation history (\<=1/\>=2 moderate/severe), smoking status at Screening, country and post-bronchodilator % predicted FEV1 at Screening.|4.3|1.0|
72419488|NCT03574597|144349743|SUPERIORITY||Hazard Ratio (HR)|0.8|||<|0.0001|TWO_SIDED|95.0|0.72|0.89|||Regression, Cox|||Data from the in-trial period. The outcome measure was analysed using a Cox proportional hazards model with treatment as categorical fixed factor. Participants without events of interest were censored at the end of their in-trial period.||0.89|0.72|< 0.0001
72419489|NCT06060457|144349778|OTHER||Geometric Mean Ratio (GMR)|0.625|||||TWO_SIDED|95.0|0.57|0.686||||||RSV-A: Arm 1 versus Arm 2||0.686|0.570|
72613209|NCT03034967|144755083|OTHER||Median Posterior Hazard Ratio|2.0|||||TWO_SIDED|90.0|0.9|4.5|||||Median Posterior Hazard Ratio, 90% credible interval for Placebo and Danirixin 50 mg has been presented.||DNX vs. Placebo statistics calculated using a Bayesian proportional hazards model including treatment, gender, exacerbation history (\<=1/\>=2 moderate/severe), smoking status at Screening, country and post-bronchodilator % predicted FEV1 at Screening.|4.5|0.9|
72613210|NCT03034967|144755086|OTHER|Bayesian proportional hazards model|Hazard Ratio (HR)|1.5|||||TWO_SIDED|90.0|1.0|2.2|||||Hazard Ratio, 90% credible interval for Placebo and Danirixin 5 mg has been presented.||DNX vs. Placebo statistics calculated using a Bayesian proportional hazards model including treatment, gender, exacerbation history (\<=1/\>=2 moderate/severe), smoking status at Screening, country and post-bronchodilator %predicted FEV1 at Screening.|2.2|1.0|
72613211|NCT03034967|144755086|OTHER|Bayesian proportional hazards model|Hazard Ratio (HR)|1.1|||||TWO_SIDED|90.0|0.8|1.7|||||Hazard Ratio, 90% credible interval for Placebo and Danirixin 10 mg has been presented.||DNX vs. Placebo statistics calculated using a Bayesian proportional hazards model including treatment, gender, exacerbation history (\<=1/\>=2 moderate/severe), smoking status at Screening, country and post-bronchodilator % predicted FEV1 at Screening.|1.7|0.8|
72613212|NCT03034967|144755086|OTHER|Bayesian proportional hazards model|Hazard Ratio (HR)|1.1|||||TWO_SIDED|90.0|0.7|1.6|||||Hazard Ratio, 90% credible interval for Placebo and Danirixin 25 mg has been presented.||DNX vs. Placebo statistics calculated using a Bayesian proportional hazards model including treatment, gender, exacerbation history (\<=1/\>=2 moderate/severe), smoking status at Screening, country and post-bronchodilator % predicted FEV1 at Screening.|1.6|0.7|
72613213|NCT03034967|144755086|OTHER|Bayesian proportional hazards model|Hazard Ratio (HR)|1.4|||||TWO_SIDED|90.0|1.0|2.1|||||Hazard Ratio, 90% credible interval for Placebo and Danirixin 35 mg has been presented.||DNX vs. Placebo statistics calculated using a Bayesian proportional hazards model including treatment, gender, exacerbation history (\<=1/\>=2 moderate/severe), smoking status at Screening, country and post-bronchodilator % predicted FEV1 at Screening.|2.1|1.0|
72613214|NCT03034967|144755086|OTHER|Bayesian proportional hazards model|Hazard Ratio (HR)|1.6|||||TWO_SIDED|90.0|1.1|2.3|||||Hazard Ratio, 90% credible interval for Placebo and Danirixin 50 mg has been presented.||DNX vs. Placebo statistics calculated using a Bayesian proportional hazards model including treatment, gender, exacerbation history (\<=1/\>=2 moderate/severe), smoking status at Screening, country and post-bronchodilator % predicted FEV1 at Screening.|2.3|1.1|
72613215|NCT03034967|144755087|OTHER|Bayesian proportional hazards model|Hazard Ratio (HR)|1.8|||||TWO_SIDED|90.0|0.7|5.5|||||Hazard Ratio, 90% credible interval for Placebo and Danirixin 5 mg has been presented.||DNX vs. Placebo statistics calculated using a Bayesian proportional hazards model including treatment, gender, exacerbation history (\<=1/\>=2 moderate/severe), smoking status at Screening, country and post-bronchodilator % predicted FEV1 at Screening.|5.5|0.7|
72613216|NCT03034967|144755087|OTHER|Bayesian proportional hazards model|Hazard Ratio (HR)|1.9|||||TWO_SIDED|90.0|0.7|5.8|||||Hazard Ratio, 90% credible interval for Placebo and Danirixin 10 mg has been presented.||DNX vs. Placebo statistics calculated using a Bayesian proportional hazards model including treatment, gender, exacerbation history (\<=1/\>=2 moderate/severe), smoking status at Screening, country and post-bronchodilator % predicted FEV1 at Screening.|5.8|0.7|
72613217|NCT03034967|144755087|OTHER|Bayesian proportional hazards model|Hazard Ratio (HR)|1.8|||||TWO_SIDED|90.0|0.7|5.6|||||Hazard Ratio, 90% credible interval for Placebo and Danirixin 25 mg has been presented.||DNX vs. Placebo statistics calculated using a Bayesian proportional hazards model including treatment, gender, exacerbation history (\<=1/\>=2 moderate/severe), smoking status at Screening, country and post-bronchodilator % predicted FEV1 at Screening.|5.6|0.7|
72613218|NCT03034967|144755087|OTHER|Bayesian proportional hazards model|Hazard Ratio (HR)|2.3|||||TWO_SIDED|90.0|0.9|6.9|||||Hazard Ratio, 90% credible interval for Placebo and Danirixin 35 mg has been presented.||DNX vs. Placebo statistics calculated using a Bayesian proportional hazards model including treatment, gender, exacerbation history (\<=1/\>=2 moderate/severe), smoking status at Screening, country and post-bronchodilator % predicted FEV1 at Screening.|6.9|0.9|
72613219|NCT03034967|144755087|OTHER|Bayesian proportional hazards model|Hazard Ratio (HR)|0.8|||||TWO_SIDED|90.0|0.2|2.7|||||Hazard Ratio, 90% credible interval for Placebo and Danirixin 50 mg has been presented.||DNX vs. Placebo statistics calculated using a Bayesian proportional hazards model including treatment, gender, exacerbation history (\<=1/\>=2 moderate/severe), smoking status at Screening, country and post-bronchodilator % predicted FEV1 at Screening.|2.7|0.2|
72613220|NCT03034967|144755090|OTHER||Odds Ratio (OR)|1.51||||0.208|TWO_SIDED|90.0|0.88|2.59||Analysis performed using a generalized linear mixed model with a logit link function including treatment, Baseline SGRQ total score, smoking status at Screening, country, visit, Baseline by visit and treatment by visit interactions.|Linear mixed model||Odds Ratio, 90% credible interval for Placebo and Danirixin 5 mg has been presented.|||2.59|0.88|0.208
72613221|NCT03034967|144755090|OTHER||Odds Ratio (OR)|1.27||||0.482|TWO_SIDED|90.0|0.73|2.2||Analysis performed using a generalized linear mixed model with a logit link function including treatment, Baseline SGRQ total score, smoking status at Screening, country, visit, Baseline by visit and treatment by visit interactions.|Linear mixed model||Odds Ratio, 90% credible interval for Placebo and Danirixin 10 mg has been presented.|||2.20|0.73|0.482
72613222|NCT03034967|144755090|OTHER||Odds Ratio (OR)|1.47||||0.239|TWO_SIDED|90.0|0.86|2.53||Analysis performed using a generalized linear mixed model with a logit link function including treatment, Baseline SGRQ total score, smoking status at Screening, country, visit, Baseline by visit and treatment by visit interactions.|Linear mixed model||Odds Ratio, 90% credible interval for Placebo and Danirixin 25 mg has been presented.|||2.53|0.86|0.239
72613223|NCT03034967|144755090|OTHER||Odds Ratio (OR)|1.31||||0.426|TWO_SIDED|90.0|0.75|2.26||Analysis performed using a generalized linear mixed model with a logit link function including treatment, Baseline SGRQ total score, smoking status at Screening, country, visit, Baseline by visit and treatment by visit interactions.|Linear mixed model||Odds Ratio, 90% credible interval for Placebo and Danirixin 35 mg has been presented.|||2.26|0.75|0.426
72326988|NCT04232943|144177560|OTHER|This study was designed to provide at least 96% power to detect ≥ 60% reduction in shedding rate in the IPV+ dmLT group assuming the shedding rate in the IPV alone group is at least 80%.|Risk Ratio (RR)|1.17|||||TWO_SIDED|95.0|0.56|2.464|||||RR = Ratio of proportions: (IPV+dmLT) / IPV|Analysis of Shedding of Poliovirus Type 1||2.464|0.560|
72419490|NCT06060457|144349778|OTHER||GMR|0.638|||||TWO_SIDED|95.0|0.584|0.697||||||RSV-B: Arm 1 versus Arm 2||0.697|0.584|
72419491|NCT01338025|144349815|SUPERIORITY_OR_OTHER|||||||0.03|TWO_SIDED||||||Log Rank|||||||0.03
72613224|NCT03034967|144755090|OTHER||Odds Ratio (OR)|0.9||||0.763|TWO_SIDED|90.0|0.52|1.58||Analysis performed using a generalized linear mixed model with a logit link function including treatment, Baseline SGRQ total score, smoking status at Screening, country, visit, Baseline by visit and treatment by visit interactions.|Linear mixed model||Odds Ratio, 90% credible interval for Placebo and Danirixin 50 mg has been presented.|||1.58|0.52|0.763
72613225|NCT03034967|144755092|OTHER||Odds Ratio (OR)|1.01||||0.973|TWO_SIDED|90.0|0.58|1.76||Analysis performed using a generalized linear mixed model with a logit link function including treatment, Baseline CAT score, smoking status at Screening, country, visit, Baseline by visit and treatment by visit interactions.|Linear mixed model||Odds Ratio, 90% credible interval for Placebo and Danirixin 5 mg has been presented.|||1.76|0.58|0.973
72613226|NCT03034967|144755092|OTHER||Odds Ratio (OR)|0.93||||0.825|TWO_SIDED|90.0|0.53|1.63||Analysis performed using a generalized linear mixed model with a logit link function including treatment, Baseline CAT score, smoking status at Screening, country, visit, Baseline by visit and treatment by visit interactions.|Linear mixed model||Odds Ratio, 90% credible interval for Placebo and Danirixin 10 mg has been presented.|||1.63|0.53|0.825
72613227|NCT03034967|144755092|OTHER||Odds Ratio (OR)|0.95||||0.887|TWO_SIDED|90.0|0.55|1.66||Analysis performed using a generalized linear mixed model with a logit link function including treatment, Baseline CAT score, smoking status at Screening, country, visit, Baseline by visit and treatment by visit interactions.|Linear mixed model||Odds Ratio, 90% credible interval for Placebo and Danirixin 25 mg has been presented.|||1.66|0.55|0.887
72613228|NCT03034967|144755092|OTHER||Odds Ratio (OR)|1.21||||0.567|TWO_SIDED|90.0|0.69|2.13||Analysis performed using a generalized linear mixed model with a logit link function including treatment, Baseline CAT score, smoking status at Screening, country, visit, Baseline by visit and treatment by visit interactions.|Linear mixed model||Odds Ratio, 90% credible interval for Placebo and Danirixin 35 mg has been presented.|||2.13|0.69|0.567
72613229|NCT03034967|144755092|OTHER||Odds Ratio (OR)|1.26||||0.501|TWO_SIDED|90.0|0.72|2.2||Analysis performed using a generalized linear mixed model with a logit link function including treatment, Baseline CAT score, smoking status at Screening, country, visit, Baseline by visit and treatment by visit interactions.|Linear mixed model||Odds Ratio, 90% credible interval for Placebo and Danirixin 50 mg has been presented.|||2.20|0.72|0.501
72613230|NCT04279483|144755103|SUPERIORITY|Linear mixed effects|Slope|-0.64|STANDARD_ERROR_OF_MEAN|1.95||0.74|TWO_SIDED|||||Statistical significance was evaluated at α = 0.05.|Mixed Models Analysis|||Our hypothesis was that craving would be higher for those in the Tobacco retailer group, relative to the Nontobacco retailer group, during the intervention phase but not the baseline phase. We tested the interaction between study phase and experimental condition, in a model where the baseline was the reference study phase and Tobacco group was the reference experimental condition.||||0.74
72613231|NCT04279483|144755103|SUPERIORITY|Linear mixed effects|Slope|-0.84|STANDARD_ERROR_OF_MEAN|2.12||0.69|TWO_SIDED|||||Statistical significance was evaluated at α = 0.05.|Mixed Models Analysis|||Our hypothesis was that craving would be higher for those in the Tobacco retailer group, relative to the control group, during the intervention phase but not the baseline phase. We tested the interaction between study phase and experimental condition, in a model where the baseline was the reference study phase and Tobacco group was the reference experimental condition.||||0.69
72613232|NCT04279483|144755104|SUPERIORITY|Linear mixed effects|Slope|-0.37|STANDARD_ERROR_OF_MEAN|0.54||0.49|TWO_SIDED|||||Statistical significance was evaluated at α = 0.05.|Mixed Models Analysis|||Our hypothesis was that cigarettes smoked would be higher for those in the Tobacco retailer group, relative to the Nontobacco retailer group, during the intervention phase but not the baseline phase. We tested the interaction between study phase and experimental condition, in a model where the baseline was the reference study phase and Tobacco group was the reference experimental condition.||||0.49
72613233|NCT04279483|144755104|SUPERIORITY|Linear mixed effects|Slope|0.21|STANDARD_ERROR_OF_MEAN|0.59||0.72|TWO_SIDED|||||Statistical significance was evaluated at α = 0.05.|Mixed Models Analysis|||Our hypothesis was that craving would be higher for those in the Tobacco retailer group, relative to the control group, during the intervention phase but not the baseline phase. We tested the interaction between study phase and experimental condition, in a model where the baseline was the reference study phase and Tobacco group was the reference experimental condition.||||0.72
72419492|NCT00789815|144349843|NON_INFERIORITY_OR_EQUIVALENCE|A preliminary study was performed to determine the sample size before this trial. 15 and 15 patients undergoing FB received BIS-guided propofol sedation and clinical-judged midazolam sedation, respectively. The incidences of hypoxemia were 0.33 and 0.20, respectively. The selected sample size of 225 in each group will yield 90% power for detecting a clinically meaningful difference of 0.13 at the 5.0% level of significance. To allow for 10% missing data, we recruited 250 patients per group.||||||0.05||95.0|||||Chi-squared|||"The null hypothesis: the incidence of hypoxemia occured during FB with BIS-guided propofol infusion is higher than that with clinical-judged midazolam administration.~Power calculation is described below."||||0.05
72419493|NCT00789815|144349844|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||Chi-squared|||The null hypothesis: the incidence of hypotension during FB in patients of study group is higher than that in the control group.||||0.05
72419494|NCT00789815|144349845|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||Chi-squared|||||||0.05
72419495|NCT00789815|144349846|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||Chi-squared|||||||0.05
72419496|NCT00789815|144349847|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||t-test, 2 sided|||||||0.05
72419497|NCT00789815|144349848|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||Wilcoxon (Mann-Whitney)|||The null hypothesis: the global tolerance of patients in study is worse than that in the control group.||||0.05
72419498|NCT00789815|144349849|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||t-test, 2 sided|||||||0.05
72419499|NCT00789815|144349850|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||Chi-squared|||||||0.05
72419500|NCT01224925|144349861|SUPERIORITY||Log Rank (Mantel-Cox)|842.0|||<|0.01|TWO_SIDED|95.0|693.0|991.0|||Log Rank|||The power calculation was based on the intention to show a 30% difference in success rates. The following parameters were used (binomial scale): type I error: 5%; expected success rate in the CH group: 55% (based on Barthel et al. 2000); minimal difference between success rates not to be overlooked: 30%; type II error: 5%. The calculations revealed the need for 64 subjects in each group. After adding 20% for eventual drop-outs, we planned to recruit 160 subjects in one year.||991|693|<0.01
72419501|NCT01224925|144349861|SUPERIORITY||Log Rank (Mantel-Cox)|1201.0|||<|0.01|TWO_SIDED|95.0|1068.0|1335.0|||Log Rank|||||1335|1068|<0.01
72419502|NCT01224925|144349862|SUPERIORITY||||||>|0.05|||||||Chi-squared|||||||>0.05
72419503|NCT00838682|144349868|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Fisher Exact|||||||<0.05
72419504|NCT00838682|144349869|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Fisher Exact|||||||<0.05
72419505|NCT00838682|144349870|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Fisher Exact|||||||<0.05
72419506|NCT00838682|144349871|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Fisher Exact|||||||<0.05
72419507|NCT00838682|144349872|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||t-test, 2 sided|||||||<0.05
72419508|NCT00838682|144349873|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||t-test, 2 sided|||||||<0.05
72419509|NCT03675451|144349885|OTHER|Clopper-Pearson (Exact) 95% confidence interval to assess precision of finding.|Proportion of Participants|0.95|||||TWO_SIDED|95.0|0.74|0.99|||||Clopper-Pearson (Exact) 95% confidence interval to assess precision of finding.|Clopper-Pearson (Exact) 95% confidence interval to assess precision of finding.||0.99|0.74|
72419510|NCT03675451|144349886|OTHER|Clopper-Pearson (Exact) 95% confidence interval to assess precision of finding.|Proportion of Participants|1.0|||||TWO_SIDED|95.0|0.66|1.0|||||Clopper-Pearson (Exact) 95% confidence interval to assess precision of finding.|Clopper-Pearson (Exact) 95% confidence interval to assess precision of finding.||1.00|0.66|
72419511|NCT04098406|144349898|SUPERIORITY||Mean Difference (Final Values)|7.7||||0.4304|TWO_SIDED|95.0|-11.9|27.3|||MMRM|||||27.3|-11.9|0.4304
72419512|NCT04098406|144349899|SUPERIORITY||Mean Difference (Final Values)|3.6||||0.6519|TWO_SIDED|95.0|-12.4|19.7|||MMRM|||||19.7|-12.4|0.6519
72419513|NCT04098406|144349900|SUPERIORITY||Mean Difference (Final Values)|18.8||||0.6158|TWO_SIDED|95.0|-56.4|94.0|||MMRM|||||94.0|-56.4|0.6158
72419514|NCT04098406|144349905|SUPERIORITY||Mean Difference (Final Values)|1.0||||0.4249|TWO_SIDED|95.0|-1.6|3.6|||MMRM|||||3.6|-1.6|0.4249
72419515|NCT04098406|144349906|SUPERIORITY|||||||0.035|||||||Chi-squared|||||||0.0350
72419516|NCT04098406|144349908|SUPERIORITY||Mean Difference (Final Values)|9.1||||0.2237|TWO_SIDED|95.0|-5.8|23.9|||ANCOVA|||||23.9|-5.8|0.2237
72419517|NCT04098406|144349909|SUPERIORITY||Hazard Ratio (HR)|0.29||||0.0125|TWO_SIDED|95.0|0.103|0.815|||Log Rank|||||0.815|0.103|0.0125
72419518|NCT04098406|144349911|SUPERIORITY||Mean Difference (Final Values)|0.9||||0.0177|TWO_SIDED|95.0|0.2|1.6|||MMRM|||||1.6|0.2|0.0177
72419519|NCT01783418|144349957|SUPERIORITY_OR_OTHER|||||||0.613|TWO_SIDED||||||ANOVA|||Baseline and Post-intervention (8 weeks)||||0.613
72419520|NCT01783418|144349958|SUPERIORITY_OR_OTHER|||||||0.957|TWO_SIDED||||||ANOVA|||Baseline, Post-intervention (8 weeks)||||0.957
72419521|NCT01783418|144349959|SUPERIORITY_OR_OTHER|||||||0.256|TWO_SIDED||||||ANOVA|||Baseline, Post-intervention (8 weeks)||||.256
72419522|NCT01783418|144349960|SUPERIORITY_OR_OTHER|||||||0.97|TWO_SIDED||||||ANOVA|||Baseline, Post-intervention (8 weeks)||||0.97
72419523|NCT01783418|144349961|SUPERIORITY_OR_OTHER|||||||0.241|TWO_SIDED||||||ANOVA|||Baseline, Post-intervention||||0.241
72419524|NCT01783418|144349962|SUPERIORITY_OR_OTHER|||||||0.358|TWO_SIDED||||||ANOVA|||Baseline, Post-intervention (8 weeks)||||0.358
72419525|NCT01783418|144349963|SUPERIORITY_OR_OTHER|||||||0.95|TWO_SIDED||||||ANOVA|||Baseline, Post-intervention (8 weeks)||||0.95
72419526|NCT00415610|144349998|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED|||||The repeated measure analysis of the hourly average SBP was calculated with and without adjusting for baseline NIHSS and age.|repeated measure|Adjusted for initial deficit severity of using baseline NIHSS instead of GCS to better discriminate among patients with GCS score \> 8.||The hourly average (of maximum and minimum) SBP measurements were graphed with box-and-whiskers plot. In addition, a repeated measures analysis of the 25 average SBP (baseline and subsequent 24 hourly measures) was conducted with a mixed effects model (assuming autoregressive covariance structure in SAS version 9.1 PROC MIXED) to determine statistically the effect of treatment intensity (tier) on the average SBP over the 24 hrs with and without adjustment for baseline NIHSS score and age.||||< 0.01
72419527|NCT00415610|144349999|SUPERIORITY_OR_OTHER||||||<|0.5|TWO_SIDED|||||Observed average SBP change at 2 hrs after treatment initiation between subjects who did or did not have neurologic deterioration within 24 hrs.|Wilcoxon rank sum test|Mean decrease measured for subjects with neurological deterioration and subjects without neurological deterioration.||Done as a surrogate to evaluate the relationship between early SBP reduction and safety events.||||< .5
72419528|NCT03595332|144350095|EQUIVALENCE|The analysis tests whether for both groups combined, the baseline to 10-week follow-up BMI percentile scores are significantly different from zero.|Mean Difference (Final Values)|1.137|STANDARD_ERROR_OF_MEAN|0.9846||0.248|TWO_SIDED|95.0|-0.793|3.067||This test compares baseline to 10-week post-test for both groups combined, to test the null hypothesis that the BMI Percentile score would not be different from zero. A p-value of 0.05 was used as a priori threshold for statistical significance.|Regression, Linear|Linear regression with Generalized Estimating Equations to account for nested data structure of 222 children nested within 150 families and 4 schools.||||3.067|-0.793|0.248
72419529|NCT03595332|144350096|EQUIVALENCE|Analysis tested whether BMI Percentile score change among overweight participants (BMI equal or greater than 85th percentile at baseline) significantly changed from baseline to follow-up (was significantly different from zero). This was a subset analysis among the highest risk participants in the study.|Mean Difference (Final Values)|-3.173|STANDARD_ERROR_OF_MEAN|1.34||0.018|TWO_SIDED|95.0|-5.806|-0.541||The p-value threshold was 0.05 for all comparisons.|Regression, Linear|Linear regression with Generalized Estimating Equations to account for nested data structure of children within schools and families.|A negative parameter suggests a decreased BMI Percentile.|||-0.541|-5.806|0.018
72613234|NCT00879658|144755132|SUPERIORITY||Negative binomial regression model|0.524||||0.148|TWO_SIDED|95.0|0.219|1.257||Pairwise comparison and p-values refer to ARR on active treatment compared to placebo. An ARR-ratio \<1 favors active treatment.|Mixed Models Analysis|Treatment compared to placebo based on negative binomial regression model, adjusted for treatment group and baseline number of relapses in prev 2 yrs.|||An ARR-ratio \<1 favors active treatment.|1.257|0.219|0.148
72613235|NCT00879658|144755132|SUPERIORITY||Negative binomial regression model|0.34||||0.041|TWO_SIDED|95.0|0.121|0.956||Pairwise comparison and p-values refer to ARR on active treatment compared to placebo. An ARR-ratio \<1 favors active treatment.|Mixed Models Analysis|Treatment compared to placebo based on negative binomial regression model, adjusted for treatment group and baseline number of relapses in prev 2 yrs.||||0.956|0.121|0.041
72613236|NCT00879658|144755132|SUPERIORITY||Negative binomial regression model|1.051||||0.899|TWO_SIDED|95.0|0.486|2.273||Pairwise comparison and p-values refer to ARR on active treatment compared to placebo. An ARR-ratio \<1 favors active treatment.|Mixed Models Analysis|Treatment compared to placebo based on negative binomial regression model, adjusted for treatment group and baseline number of relapses in prev 2 yrs.||||2.273|0.486|0.899
72419530|NCT03595332|144350097|EQUIVALENCE|Analysis tested the difference in BMI percentile between baseline and 1-year follow-up among participants in the immediate intervention group to test the null hypothesis that no change occurred.|Mean Difference (Final Values)|0.363|STANDARD_ERROR_OF_MEAN|1.676||0.829|TWO_SIDED|95.0|-2.922|3.648||A prior threshold for statistical significance was 0.05. No adjustment for multiple comparisons was made.|Regression, Linear|Analysis included Generalized Estimating Equations with linear response variable, accounting for nested data structure.||||3.648|-2.922|0.829
72419531|NCT03595332|144350098|EQUIVALENCE|Analysis test whether for both groups combined, Baseline to 10-week change in reported intention of physical activity was significantly different from zero.|Mean Difference (Final Values)|0.284|STANDARD_ERROR_OF_MEAN|0.128||0.026|TWO_SIDED|95.0|0.034|0.534||A priori threshold for statistical significance is 0.05. No adjustments for multiple comparisons were made.|Regression, Linear|Linear regression models with Generalized Estimating Equations to account for nested data were made.|A positive parameter would suggest an increase in intentions to be physically active.|||0.534|0.034|0.026
72419532|NCT00117676|144350099|NON_INFERIORITY_OR_EQUIVALENCE|With a sample size of 200 subjects in the tenofovir DF group and 100 subjects in the adefovir dipivoxil group, a two group large-sample normal approximation test of proportions with a one-sided 0.025 significance level would have 95% power to reject the null hypothesis that the tenofovir DF treatment was inferior to the adefovir dipivoxil treatment (difference in proportions was less than -0.100) in favor of the alternative hypothesis that the tenofovir DF treatment was not inferior.|Difference in proportions|23.5|STANDARD_ERROR_OF_MEAN|5.2|<|0.001|TWO_SIDED|95.0|13.2|33.8||P-value corresponds to a Z-test of the null hypothesis that the stratum-adjusted (baseline ALT ≥ 2 x ULN or \> 2 x ULN) difference is 0.|Z-test|||A two-sided 95% confidence interval (CI), stratified by baseline ALT (≤ 2 x ULN or \> 2 x ULN) was used to evaluate the difference (tenofovir DF - adefovir dipivoxil) in the proportion of complete responders between treatment groups.||33.8|13.2|<0.001
72419533|NCT00117676|144350100|SUPERIORITY_OR_OTHER||Difference in proportions|30.3|STANDARD_ERROR_OF_MEAN|4.6|<|0.001|TWO_SIDED|95.0|21.3|39.2||P-value corresponds to a Z-test of the null hypothesis that the stratum-adjusted difference is zero. Difference, standard error of the difference, and the CI are stratum adjusted based on baseline ALT category (≤ 2 x ULN or \> 2 x ULN).|Z-test|||||39.2|21.3|<0.001
72419534|NCT00117676|144350101|SUPERIORITY_OR_OTHER||Difference in proportions|1.4|STANDARD_ERROR_OF_MEAN|3.4||0.672|TWO_SIDED|95.0|-5.2|8.0||P-value corresponds to a Z-test of the null hypothesis that the stratum-adjusted difference is zero. Two-sided 95% confidence intervals, stratified by baseline ALT (baseline ALT ≤ 2 x ULN, \> 2 x ULN), were used to evaluate treatment arm differences.|Z-test|||||8.0|-5.2|0.672
72419535|NCT00117676|144350106|SUPERIORITY_OR_OTHER||Difference in proportions|5.2|STANDARD_ERROR_OF_MEAN|5.0||0.293|TWO_SIDED|95.0|-4.5|14.9||P-value corresponds to a Z-test of the null hypothesis that the stratum-adjusted difference is zero. Confidence interval stratum adjusted based on baseline ALT (≤ 2 x ULN, \> 2 x ULN).|Z-test|||||14.9|-4.5|0.293
72419536|NCT00117676|144350112|SUPERIORITY_OR_OTHER||Difference in proportions|-0.8|STANDARD_ERROR_OF_MEAN|4.8||0.859|TWO_SIDED|95.0|-10.2|8.5||Statistical tests were not adjusted for baseline ALT stratum. Analysis set included only randomized and treated participants with baseline ALT \> ULN (biochemically evaluable analysis set).|Z-test|P-value corresponds to a Z-test of the null hypothesis that the ALT stratum-adjusted difference is zero.||||8.5|-10.2|0.859
72419537|NCT00117676|144350113|SUPERIORITY_OR_OTHER||Difference in proportions|4.9|STANDARD_ERROR_OF_MEAN|5.3||0.359|TWO_SIDED|95.0|-5.5|15.3||P-value corresponds to a Z-test of the null hypothesis that the ALT stratum-adjusted difference is zero.|Z-test|Difference, standard error of the difference, and confidence interval are stratum adjusted (baseline ALT ≤ 2 x ULN or \> 2 x ULN).||||15.3|-5.5|0.359
72613237|NCT00879658|144755133|OTHER|Pairwise comparison of treatments to placebo are based on odds ratios estimated from a logistic regression model adjusted for treatment group and using number of relapses in the previous 2 years as a covariate.|Logistic regression model|0.915||||0.879|TWO_SIDED|95.0|0.288|2.925|||Regression, Logistic|"Proportions are estimated from the logistic regression model.~\- An odds ratio of \> 1 indicates an increased odds in favor of the active treatment."||||2.925|0.288|0.879
72419538|NCT00952822|144350131|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence limits of -0.223 to 0.223 in accordance with FDA Guidance for Industry: Statistical Approaches to Establishing Bioequivalence; 2001.|Difference of Least-Squares Means|-0.052||||||90.0|-0.117|0.012||||||||0.012|-0.117|
72419539|NCT00952822|144350132|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence limits of -0.223 to 0.223 in accordance with FDA Guidance for Industry: Statistical Approaches to Establishing Bioequivalence; 2001.|Difference of Least-Squares Means|-0.016||||||90.0|-0.076|0.043||||||||0.043|-0.076|
72419540|NCT01250990|144350146|SUPERIORITY_OR_OTHER|||||||0.8||||||p value is for comparison between changes in reverse cholesterol transport in niacin versus placebo groups after 12 weeks of treatment.|t-test, 2 sided|||This is a pilot study to assess the effects of niacin on reverse cholesterol transport. The null hypothesis is that niacin has no effect on reverse cholesterol transport.||||0.8
72419541|NCT05007392|144350193|SUPERIORITY||Difference of percentage|35.87|||<|0.001|TWO_SIDED|95.0|27.36|44.37|||Cochran-Mantel-Haenszel|P value based on a Cochran-Mantel-Haenszel test stratified by baseline SUA level and baseline body mass index (BMI) level.|The difference of percentage and stratified 95 percent (%) confidence interval (CI) was based on Mantel-Haenszel method.|||44.37|27.36|<0.001
72613238|NCT00879658|144755133|OTHER|Pairwise comparison of treatments to placebo are based on odds ratios estimated from a logistic regression model adjusted for treatment group and using number of relapses in the previous 2 years as a covariate.|Logistic regression model|1.745||||0.399|TWO_SIDED|95.0|0.484|7.167||"Proportions are estimated from the logistic regression model.~\- An odds ratio of \> 1 indicates an increased odds in favor of the active treatment."|Regression, Logistic|||||7.167|0.484|0.399
72613239|NCT00879658|144755133|OTHER|Pairwise comparison of treatments to placebo are based on odds ratios estimated from a logistic regression model adjusted for treatment group and using number of relapses in the previous 2 years as a covariate.|Logistic regression model|1.697||||0.454|TWO_SIDED|95.0|0.438|8.296||"Proportions are estimated from the logistic regression model.~\- An odds ratio of \> 1 indicates an increased odds in favor of the active treatment."|Regression, Logistic|||||8.296|0.438|0.454
72419542|NCT05007392|144350194|NON_INFERIORITY|The prespecified non-inferiority margin was -10% in the analysis.|Difference of percentage|5.24|||||TWO_SIDED|95.0|-3.69|14.17|||||The difference of percentage and stratified 95% CI was based on Mantel-Haenszel method.|||14.17|-3.69|
72419543|NCT01218126|144350199|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.6||||0.517|TWO_SIDED|95.0|-10.4|5.2|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Placebo versus Losmapimod 2.5 mg at Week 4.||5.2|-10.4|0.517
72419544|NCT01218126|144350199|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.2||||0.763|TWO_SIDED|95.0|-8.9|6.5|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Placebo versus Losmapimod 7.5 mg at Week 4||6.5|-8.9|0.763
72613240|NCT00879658|144755133|OTHER|Pairwise comparison of treatments to placebo are based on odds ratios estimated from a logistic regression model adjusted for treatment group and using number of relapses in the previous 2 years as a covariate.|Logistic regression model|0.509||||0.223|TWO_SIDED|95.0|0.166|1.511||"Proportions are estimated from the logistic regression model.~\- An odds ratio of \> 1 indicates an increased odds in favor of the active treatment."|Regression, Logistic|||||1.511|0.166|0.223
72419545|NCT01218126|144350199|SUPERIORITY_OR_OTHER||Mean Difference (Net)|5.5||||0.164|TWO_SIDED|95.0|-2.3|13.3|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Placebo versus Losmapimod 15 mg at Week 4||13.3|-2.3|0.164
72613241|NCT00879658|144755133|OTHER|Pairwise comparison of treatments to placebo are based on odds ratios estimated from a logistic regression model adjusted for treatment group and using number of relapses in the previous 2 years as a covariate.|Logistic regression model|0.785||||0.668|TWO_SIDED|95.0|0.253|2.392||"Proportions are estimated from the logistic regression model.~\- An odds ratio of \> 1 indicates an increased odds in favor of the active treatment."|Regression, Logistic|||||2.392|0.253|0.668
72613242|NCT00879658|144755134|OTHER|Pairwise comparison of treatments to placebo are based on odds ratios estimated from a logistic regression model adjusted for treatment group and using number of relapses in the previous 2 years as a covariate.|Logistic regression model|1.996||||0.178|TWO_SIDED|95.0|0.731|5.669|||Regression, Logistic|Proportions are estimated from the logistic regression model. - An odds ratio of \> 1 indicates an increased odds in favor of the active treatment.||||5.669|0.731|0.178
72613243|NCT00879658|144755134|OTHER|Pairwise comparison of treatments to placebo are based on odds ratios estimated from a logistic regression model adjusted for treatment group and using number of relapses in the previous 2 years as a covariate.|Logistic regression model|4.12||||0.014|TWO_SIDED|95.0|1.328|14.681||Proportions are estimated from the logistic regression model. - An odds ratio of \> 1 indicates an increased odds in favor of the active treatment.|Regression, Logistic|||||14.681|1.328|0.014
72613244|NCT00879658|144755134|OTHER|Pairwise comparison of treatments to placebo are based on odds ratios estimated from a logistic regression model adjusted for treatment group and using number of relapses in the previous 2 years as a covariate.|Logistic regression model|1.266||||0.642|TWO_SIDED|95.0|0.468|3.494||Proportions are estimated from the logistic regression model. - An odds ratio of \> 1 indicates an increased odds in favor of the active treatment.|Regression, Logistic|||||3.494|0.468|0.642
72613245|NCT00879658|144755135|SUPERIORITY||lesion ratio|0.138|||<|0.001|TWO_SIDED|95.0|0.047|0.408|||Regression, Logistic|new Gd-enhanced T1 lesions was compared between treatment groups using a negative binomial generalized estimating equation regression model||Pairwise treatment comparison between different BAF312 dose groups and placebo used a two-sided significance level of 5% without adjusting for multiplicity.||0.408|0.047|<0.001
72419546|NCT01218126|144350199|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.6||||0.9|TWO_SIDED|95.0|-9.2|10.5|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Placebo versus Losmapimod 2.5 mg at Week 12||10.5|-9.2|0.900
72326989|NCT04232943|144177560|OTHER|This study was designed to provide at least 96% power to detect ≥ 60% reduction in shedding rate in the IPV+ dmLT group assuming the shedding rate in the IPV alone group is at least 80%.|Risk Ratio (RR)|0.97|||||TWO_SIDED|95.0|0.606|1.51|||||RR = Ratio of proportions: (IPV+dmLT) / IPV|Analysis of Shedding of Poliovirus Type 3||1.510|0.606|
72326990|NCT03896477|144177580|OTHER||GMC Ratio|2.91|||||TWO_SIDED|95.0|2.47|3.44||||||Serotype 1 geometric mean concentration ratio (Pneumosil / Synflorix) and 95% confidence interval (CI). Differences between groups were considered statistically significant if the 95% CI excludes 1.||3.44|2.47|
72326991|NCT03896477|144177580|OTHER||GMC Ratio|1.44|||||TWO_SIDED|95.0|1.23|1.69||||||Serotype 1 geometric mean concentration ratio (Pneumosil / Prevenar 13) and 95% confidence interval (CI). Differences between groups were considered statistically significant if the 95% CI excludes 1.||1.69|1.23|
72326992|NCT03896477|144177580|OTHER||GMC Ratio|1.93|||||TWO_SIDED|95.0|1.66|2.25||||||Serotype 5 geometric mean concentration ratio (Pneumosil / Synflorix) and 95% confidence interval (CI). Differences between groups were considered statistically significant if the 95% CI excludes 1.||2.25|1.66|
72326993|NCT03896477|144177580|OTHER||GMC Ratio|0.76|||||TWO_SIDED|95.0|0.65|0.88||||||Serotype 5 geometric mean concentration ratio (Pneumosil / Prevenar 13) and 95% confidence interval (CI). Differences between groups were considered statistically significant if the 95% CI excludes 1.||0.88|0.65|
72419547|NCT01218126|144350199|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.3||||0.788|TWO_SIDED|95.0|-11.1|8.4|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Placebo versus Losmapimod 7.5 mg at Week 12||8.4|-11.1|0.788
72419548|NCT01218126|144350199|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.8||||0.722|TWO_SIDED|95.0|-8.2|11.8|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Placebo versus Losmapimod 15 mg at Week 12||11.8|-8.2|0.722
72326994|NCT03896477|144177580|OTHER||GMC Ratio|16.03|||||TWO_SIDED|95.0|12.84|20.03||||||Serotype 6A geometric mean concentration ratio (Pneumosil / Synflorix) and 95% confidence interval (CI). Differences between groups were considered statistically significant if the 95% CI excludes 1.||20.03|12.84|
72419549|NCT01218126|144350199|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-6.7||||0.26|TWO_SIDED|95.0|-18.2|4.9|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Placebo versus Losmapimod 2.5 mg at Week 24||4.9|-18.2|0.260
72326995|NCT03896477|144177580|OTHER||GMC Ratio|0.87|||||TWO_SIDED|95.0|0.72|1.06||||||Serotype 6A geometric mean concentration ratio (Pneumosil / Prevenar 13) and 95% confidence interval (CI). Differences between groups were considered statistically significant if the 95% CI excludes 1.||1.06|0.72|
72326996|NCT03896477|144177580|OTHER||GMC Ratio|2.51|||||TWO_SIDED|95.0|2.14|2.95||||||Serotype 6B geometric mean concentration ratio (Pneumosil / Synflorix) and 95% confidence interval (CI). Differences between groups were considered statistically significant if the 95% CI excludes 1.||2.95|2.14|
72326997|NCT03896477|144177580|OTHER||GMC Ratio|0.8|||||TWO_SIDED|95.0|0.68|0.95||||||Serotype 6B geometric mean concentration ratio (Pneumosil / Prevenar 13) and 95% confidence interval (CI). Differences between groups were considered statistically significant if the 95% CI excludes 1.||0.95|0.68|
72326998|NCT03896477|144177580|OTHER||GMC Ratio|2.11|||||TWO_SIDED|95.0|1.83|2.44||||||Serotype 7F geometric mean concentration ratio (Pneumosil / Synflorix) and 95% confidence interval (CI). Differences between groups were considered statistically significant if the 95% CI excludes 1.||2.44|1.83|
72326999|NCT03896477|144177580|OTHER||GMC Ratio|1.05|||||TWO_SIDED|95.0|0.91|1.22||||||Serotype 7F geometric mean concentration ratio (Pneumosil / Prevenar 13) and 95% confidence interval (CI). Differences between groups were considered statistically significant if the 95% CI excludes 1.||1.22|0.91|
72327000|NCT03896477|144177580|OTHER||GMC Ratio|1.41|||||TWO_SIDED|95.0|1.21|1.65||||||Serotype 9V geometric mean concentration ratio (Pneumosil / Synflorix) and 95% confidence interval (CI). Differences between groups were considered statistically significant if the 95% CI excludes 1.||1.65|1.21|
72327001|NCT03896477|144177580|OTHER||GMC Ratio|0.89|||||TWO_SIDED|95.0|0.76|1.05||||||Serotype 9V geometric mean concentration ratio (Pneumosil / Prevenar 13) and 95% confidence interval (CI). Differences between groups were considered statistically significant if the 95% CI excludes 1.||1.05|0.76|
72613246|NCT00879658|144755135|SUPERIORITY||lesion ratio|0.307||||0.012|TWO_SIDED|95.0|0.123|0.771||new Gd-enhanced T1 lesions was compared between treatment groups using a negative binomial generalized estimating equation regression model.|Regression, Logistic|||Pairwise treatment comparison between different BAF312 dose group and placebo used a two-sided significance level of 5% without adjusting for multiplicity.||0.771|0.123|0.012
72613247|NCT00879658|144755135|SUPERIORITY||lesion ratio|0.113|||<|0.001|TWO_SIDED|95.0|0.036|0.358||new Gd-enhanced T1 lesions was compared between treatment groups using a negative binomial generalized estimating equation regression model|Regression, Logistic|||Pairwise treatment comparison between different BAF312 dose group and placebo used a two-sided significance level of 5% without adjusting for multiplicity.||0.358|0.036|<0.001
72613248|NCT00879658|144755135|SUPERIORITY||lesion ratio|0.375||||0.021|TWO_SIDED|95.0|0.163|0.86||new Gd-enhanced T1 lesions was compared between treatment groups using a negative binomial generalized estimating equation regression model|Regression, Logistic|||Pairwise treatment comparison between different BAF312 dose group and placebo used a two-sided significance level of 5% without adjusting for multiplicity.||0.860|0.163|0.021
72613249|NCT00879658|144755135|SUPERIORITY||lesion ratio|0.478||||0.062|TWO_SIDED|95.0|0.22|1.037||new Gd-enhanced T1 lesions was compared between treatment groups using a negative binomial generalized estimating equation regression model|Regression, Logistic|||Pairwise treatment comparison between different BAF312 dose group and placebo used a two-sided significance level of 5% without adjusting for multiplicity.||1.037|0.220|0.062
72613250|NCT00879658|144755136|SUPERIORITY|Pairwise treatment comparison between different BAF312 dose group and placebo used a two-sided significance level of 5% without adjusting for multiplicity.|Lesion ratio|0.154|||<|0.001|TWO_SIDED|95.0|0.063|0.376|||Regression, Logistic|new lesions was compared between treatment groups using a negative binomial generalized estimating equation regression model||||0.376|0.063|<0.001
72613251|NCT00879658|144755136|SUPERIORITY||lesion ratio|0.228||||0.005|TWO_SIDED|95.0|0.081|0.641||new Gd-enhanced T1 lesions was compared between treatment groups using a negative binomial generalized estimating equation regression model.|Regression, Logistic|||Pairwise treatment comparison between different BAF312 dose group and placebo used a two-sided significance level of 5% without adjusting for multiplicity.||0.641|0.081|0.005
72613252|NCT00879658|144755136|SUPERIORITY||lesion ratio|0.188|||<|0.001|TWO_SIDED|95.0|0.07|0.509||new Gd-enhanced T1 lesions was compared between treatment groups using a negative binomial generalized estimating equation regression model.|Regression, Logistic|||Pairwise treatment comparison between different BAF312 dose group and placebo used a two-sided significance level of 5% without adjusting for multiplicity.||0.509|0.070|<0.001
72613253|NCT00879658|144755137|SUPERIORITY|Pairwise treatment comparison between different BAF312 dose group and placebo used a two-sided significance level of 5% without adjusting for multiplicity.|lesion ratio|0.279||||0.002|TWO_SIDED|95.0|0.124|0.628||new Gd-enhanced T1 lesions was compared between treatment groups using a negative binomial generalized estimating equation regression model|Regression, Logistic|||||0.628|0.124|0.002
72613254|NCT00879658|144755137|SUPERIORITY||lesion ratio|0.396||||0.019|TWO_SIDED|95.0|0.182|0.861||new Gd-enhanced T1 lesions was compared between treatment groups using a negative binomial generalized estimating equation regression model.|Regression, Logistic|||Pairwise treatment comparison between different BAF312 dose group and placebo used a two-sided significance level of 5% without adjusting for multiplicity.||0.861|0.182|0.019
72613255|NCT00879658|144755137|SUPERIORITY||lesion ratio|0.154|||<|0.001|TWO_SIDED|95.0|0.059|0.4||new Gd-enhanced T1 lesions was compared between treatment groups using a negative binomial generalized estimating equation regression model.|Regression, Logistic|||Pairwise treatment comparison between different BAF312 dose group and placebo used a two-sided significance level of 5% without adjusting for multiplicity.||0.400|0.059|<0.001
72613256|NCT00879658|144755137|SUPERIORITY||lesion ratio|0.454||||0.035|TWO_SIDED|95.0|0.219|0.945||new Gd-enhanced T1 lesions was compared between treatment groups using a negative binomial generalized estimating equation regression model.|Regression, Logistic|||Pairwise treatment comparison between different BAF312 dose group and placebo used a two-sided significance level of 5% without adjusting for multiplicity.||0.945|0.219|0.035
72327002|NCT03896477|144177580|OTHER||GMC Ratio|1.65|||||TWO_SIDED|95.0|1.29|2.1||||||Serotype 14 geometric mean concentration ratio (Pneumosil / Synflorix) and 95% confidence interval (CI). Differences between groups were considered statistically significant if the 95% CI excludes 1.||2.10|1.29|
72327003|NCT03896477|144177580|OTHER||GMC Ratio|0.9|||||TWO_SIDED|95.0|0.73|1.12||||||Serotype 14 geometric mean concentration ratio (Pneumosil / Prevenar 13) and 95% confidence interval (CI). Differences between groups were considered statistically significant if the 95% CI excludes 1.||1.12|0.73|
72613257|NCT00879658|144755137|SUPERIORITY||lesion ratio|0.555||||0.087|TWO_SIDED|96.0|0.283|1.09||new Gd-enhanced T1 lesions was compared between treatment groups using a negative binomial generalized estimating equation regression model.|Regression, Logistic|||Pairwise treatment comparison between different BAF312 dose group and placebo used a two-sided significance level of 5% without adjusting for multiplicity.||1.090|0.283|0.087
72613258|NCT00879658|144755138|SUPERIORITY|Pairwise treatment comparison between different BAF312 dose group and placebo used a two-sided significance level of 5% without adjusting for multiplicity.|lesion ratio|0.095|||<|0.001|TWO_SIDED|95.0|0.033|0.273||new Gd-enhanced T1 lesions was compared between treatment groups using a negative binomial generalized estimating equation regression model|Regression, Logistic|||||0.273|0.033|<0.001
72613259|NCT00879658|144755138|SUPERIORITY||lesion ratio|0.18|||<|0.001|TWO_SIDED|95.0|0.069|0.47||new Gd-enhanced T1 lesions was compared between treatment groups using a negative binomial generalized estimating equation regression model.|Regression, Logistic|||Pairwise treatment comparison between different BAF312 dose group and placebo used a two-sided significance level of 5% without adjusting for multiplicity.||0.470|0.069|<0.001
72327004|NCT03896477|144177580|OTHER||GMC Ratio|3.69|||||TWO_SIDED|95.0|2.91|4.67||||||Serotype 19A geometric mean concentration ratio (Pneumosil / Synflorix) and 95% confidence interval (CI). Differences between groups were considered statistically significant if the 95% CI excludes 1.||4.67|2.91|
72327005|NCT03896477|144177580|OTHER||GMC Ratio|0.72|||||TWO_SIDED|95.0|0.6|0.87||||||Serotype 19A geometric mean concentration ratio (Pneumosil / Prevenar 13) and 95% confidence interval (CI). Differences between groups were considered statistically significant if the 95% CI excludes 1.||0.87|0.60|
72327006|NCT03896477|144177580|OTHER||GMC Ratio|0.64|||||TWO_SIDED|95.0|0.52|0.79||||||Serotype 19F geometric mean concentration ratio (Pneumosil / Synflorix) and 95% confidence interval (CI). Differences between groups were considered statistically significant if the 95% CI excludes 1.||0.79|0.52|
72327007|NCT03896477|144177580|OTHER||GMC Ratio|0.74|||||TWO_SIDED|95.0|0.62|0.89||||||Serotype 19F geometric mean concentration ratio (Pneumosil / Prevenar 13) and 95% confidence interval (CI). Differences between groups were considered statistically significant if the 95% CI excludes 1.||0.89|0.62|
72327008|NCT03896477|144177580|OTHER||GMC Ratio|2.29|||||TWO_SIDED|95.0|1.89|2.76||||||Serotype 23F geometric mean concentration ratio (Pneumosil / Synflorix) and 95% confidence interval (CI). Differences between groups were considered statistically significant if the 95% CI excludes 1.||2.76|1.89|
72613260|NCT00879658|144755138|SUPERIORITY||lesion ratio|0.173|||<|0.001|TWO_SIDED|95.0|0.069|0.434||new Gd-enhanced T1 lesions was compared between treatment groups using a negative binomial generalized estimating equation regression model.|Regression, Logistic|||Pairwise treatment comparison between different BAF312 dose group and placebo used a two-sided significance level of 5% without adjusting for multiplicity.||0.434|0.069|<0.001
72327009|NCT03896477|144177580|OTHER||GMC Ratio|1.0|||||TWO_SIDED|95.0|0.82|1.22||||||Serotype 23F geometric mean concentration ratio (Pneumosil / Prevenar 13) and 95% confidence interval (CI). Differences between groups were considered statistically significant if the 95% CI excludes 1.||1.22|0.82|
72613261|NCT00879658|144755139|SUPERIORITY|Pairwise treatment comparison between different BAF312 dose group and placebo used a two-sided significance level of 5% without adjusting for multiplicity.|lesion ratio|0.259||||0.005|TWO_SIDED|95.0|0.1|0.67||new Gd-enhanced T1 lesions was compared between treatment groups using a negative binomial generalized estimating equation regression model|Regression, Logistic|||||0.670|0.100|0.005
72327010|NCT01000506|144177620|SUPERIORITY_OR_OTHER||Rate Ratio|0.52|||<|0.001|TWO_SIDED|95.0|0.39|0.69||Hochberg testing procedure with a one-sided alpha of 2.5% used for controlling multiplicity|Negative Binomial regression model||Number of exacerbations per year in the mepolizumab 75mg IV arm divided by the number of exacerbations per year in the placebo arm.|||0.69|0.39|<0.001
72327011|NCT01000506|144177620|SUPERIORITY_OR_OTHER||Rate Ratio|0.61|||<|0.001|TWO_SIDED|95.0|0.46|0.81||Hochberg testing procedure with a one-sided alpha of 2.5% used for controlling multiplicity|Negative Binomial regression model||Number of exacerbations per year in the mepolizumab 250 mg IV arm divided by the number of exacerbations per year in the placebo arm.|||0.81|0.46|<0.001
72327012|NCT01000506|144177620|SUPERIORITY_OR_OTHER||Rate Ratio|0.48|||<|0.001|TWO_SIDED|95.0|0.36|0.64||Hochberg testing procedure with a one-sided alpha of 2.5% used for controlling multiplicity|Negative Binomial regression model||Number of exacerbations per year in the mepolizumab 750 mg IV arm divided by the number of exacerbations per year in the placebo arm.|||0.64|0.36|<0.001
72613262|NCT00879658|144755139|SUPERIORITY||lesion ratio|0.276||||0.005|TWO_SIDED|95.0|0.112|0.676||new Gd-enhanced T1 lesions was compared between treatment groups using a negative binomial generalized estimating equation regression model.|Regression, Logistic|||Pairwise treatment comparison between different BAF312 dose group and placebo used a two-sided significance level of 5% without adjusting for multiplicity.||0.676|0.112|0.005
72327013|NCT00889707|144177661|SUPERIORITY_OR_OTHER|||||||0.04||||||Test of superiority computed using an ANCOVA model with terms for treatment group, baseline total IPSS, and baseline prostate volume. Tested for 2-sided 0.05 level of statistical significance.|ANCOVA|ANCOVA model with terms for treatment group, baseline total IPSS, and baseline prostate volume.||||||0.040
72613263|NCT00879658|144755139|SUPERIORITY||lesion ratio|0.118|||<|0.001|TWO_SIDED|95.0|0.034|0.409||new Gd-enhanced T1 lesions was compared between treatment groups using a negative binomial generalized estimating equation regression model.|Regression, Logistic|||Pairwise treatment comparison between different BAF312 dose group and placebo used a two-sided significance level of 5% without adjusting for multiplicity.||0.409|0.034|<0.001
72613264|NCT00879658|144755139|SUPERIORITY||lesion ratio|0.683||||0.485|TWO_SIDED|95.0|0.234|1.991||new Gd-enhanced T1 lesions was compared between treatment groups using a negative binomial generalized estimating equation regression model.|Regression, Logistic|||Pairwise treatment comparison between different BAF312 dose group and placebo used a two-sided significance level of 5% without adjusting for multiplicity.||1.991|0.234|0.485
72613265|NCT00879658|144755139|SUPERIORITY||lesion ratio|0.591||||0.142|TWO_SIDED|95.0|0.292|1.193||new Gd-enhanced T1 lesions was compared between treatment groups using a negative binomial generalized estimating equation regression model.|Regression, Logistic|||Pairwise treatment comparison between different BAF312 dose group and placebo used a two-sided significance level of 5% without adjusting for multiplicity.||1.193|0.292|0.142
72613266|NCT00879658|144755140|SUPERIORITY|Pairwise treatment comparison between different BAF312 dose group and placebo used a two-sided significance level of 5% without adjusting for multiplicity.|lesion ratio|0.161|||<|0.001|TWO_SIDED|95.0|0.062|0.421||new Gd-enhanced T1 lesions was compared between treatment groups using a negative binomial generalized estimating equation regression model|Regression, Logistic|||||0.421|0.062|<0.001
72613267|NCT00879658|144755140|SUPERIORITY||lesion ratio|0.197||||0.001|TWO_SIDED|95.0|0.074|0.527||new Gd-enhanced T1 lesions was compared between treatment groups using a negative binomial generalized estimating equation regression model.|Regression, Logistic|||Pairwise treatment comparison between different BAF312 dose group and placebo used a two-sided significance level of 5% without adjusting for multiplicity.||0.527|0.074|0.001
72613268|NCT00879658|144755140|SUPERIORITY||lesion ratio|0.416||||0.139|TWO_SIDED|95.0|0.13|1.331||new Gd-enhanced T1 lesions was compared between treatment groups using a negative binomial generalized estimating equation regression model.|Regression, Logistic|||Pairwise treatment comparison between different BAF312 dose group and placebo used a two-sided significance level of 5% without adjusting for multiplicity.||1.331|0.130|0.139
72613269|NCT00879658|144755141|SUPERIORITY|||||||0.227||||||Calculated using weighted logistic regression model adj. for tx group and baseline number of Gd-enhanced T1 lesions. Weight used is equal to 1 if all post-baseline scans up to month 3 are available and (k-x)/k if x scans out of k scans are missing.|Regression, Logistic|||||||0.227
72613270|NCT00879658|144755141|SUPERIORITY|||||||0.02||||||Calculated using weighted logistic regression model adj. for tx group and baseline number of Gd-enhanced T1 lesions. Weight used is equal to 1 if all post-baseline scans up to month 3 are available and (k-x)/k if x scans out of k scans are missing.|Regression, Logistic|||||||0.020
72613271|NCT00879658|144755141|SUPERIORITY|||||||0.001||||||Calculated using weighted logistic regression model adj. for tx group and baseline number of Gd-enhanced T1 lesions. Weight used is equal to 1 if all post-baseline scans up to month 3 are available and (k-x)/k if x scans out of k scans are missing.|Regression, Logistic|||||||0.001
72613272|NCT00879658|144755141|SUPERIORITY|||||||0.122||||||Calculated using weighted logistic regression model adj. for tx group and baseline number of Gd-enhanced T1 lesions. Weight used is equal to 1 if all post-baseline scans up to month 3 are available and (k-x)/k if x scans out of k scans are missing.|Regression, Logistic|||||||0.122
72613273|NCT00879658|144755141|SUPERIORITY|||||||0.034||||||Calculated using weighted logistic regression model adj. for tx group and baseline number of Gd-enhanced T1 lesions. Weight used is equal to 1 if all post-baseline scans up to month 3 are available and (k-x)/k if x scans out of k scans are missing.|Regression, Logistic|||||||0.034
72613274|NCT00879658|144755142|SUPERIORITY|||||||0.335||||||Calculated using weighted logistic regression model adj. for tx group and baseline number of Gd-enhanced T1 lesions. Weight used is equal to 1 if all post-baseline scans up to month 3 are available and (k-x)/k if x scans out of k scans are missing.|Regression, Logistic|||||||0.335
72613275|NCT00879658|144755142|SUPERIORITY|||||||0.022||||||Calculated using weighted logistic regression model adj. for tx group and baseline number of Gd-enhanced T1 lesions. Weight used is equal to 1 if all post-baseline scans up to month 3 are available and (k-x)/k if x scans out of k scans are missing.|Regression, Logistic|||||||0.022
72613276|NCT00879658|144755142|SUPERIORITY|||||||0.124||||||Calculated using weighted logistic regression model adj. for tx group and baseline number of Gd-enhanced T1 lesions. Weight used is equal to 1 if all post-baseline scans up to month 3 are available and (k-x)/k if x scans out of k scans are missing.|Regression, Logistic|||||||0.124
72613277|NCT00879658|144755143|SUPERIORITY|Pairwise comparison of treatments are based on a negative binomial GEE regression model accounting for repeated measures on each patient, adjusted for baseline number of Gd-enhanced T1 lesions and treatment group x month (the month number of each lesion count measurement) interaction, using the log link.|lesion ratio|0.129||||0.006|TWO_SIDED|95.0|0.03|0.561||p-value corresponds to the lesion ratio and 95% CI of lesion ratio for active treatment in comparison to placebo.|Regression, Logistic|||||0.561|0.030|0.006
72613278|NCT00879658|144755143|SUPERIORITY|Pairwise comparison of treatments are based on a negative binomial GEE regression model accounting for repeated measures on each patient, adjusted for baseline number of Gd-enhanced T1 lesions and treatment group x month (the month number of each lesion count measurement) interaction, using the log link.|lesion ratio|0.159||||0.005|TWO_SIDED|95.0|0.044|0.578||p-value corresponds to the lesion ratio and 95% CI of lesion ratio for active treatment in comparison to placebo.|Regression, Logistic|||||0.578|0.044|0.005
72613279|NCT00879658|144755143|SUPERIORITY|Pairwise comparison of treatments are based on a negative binomial GEE regression model accounting for repeated measures on each patient, adjusted for baseline number of Gd-enhanced T1 lesions and treatment group x month (the month number of each lesion count measurement) interaction, using the log link.|lesion ratio|0.052||||0.005|TWO_SIDED|95.0|0.007|0.405||p-value corresponds to the lesion ratio and 95% CI of lesion ratio for active treatment in comparison to placebo.|Regression, Logistic|||||0.405|0.007|0.005
72613280|NCT00879658|144755143|SUPERIORITY||lesion ratio|0.271||||0.019|TWO_SIDED|95.0|0.091|0.807||p-value corresponds to the lesion ratio and 95% CI of lesion ratio for active treatment in comparison to placebo.|Regression, Logistic|||Pairwise comparison of treatments are based on a negative binomial GEE regression model accounting for repeated measures on each patient, adjusted for baseline number of Gd-enhanced T1 lesions and treatment group x month (the month number of each lesion count measurement) interaction, using the log link.||0.807|0.091|0.019
72419550|NCT01218126|144350199|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.7||||0.422|TWO_SIDED|95.0|-16.1|6.8|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Placebo versus Losmapimod 7.5 mg at Week 24||6.8|-16.1|0.422
72419551|NCT01218126|144350199|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.4||||0.564|TWO_SIDED|95.0|-15.1|8.2|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Placebo versus Losmapimod 15 mg at Week 24||8.2|-15.1|0.564
72419552|NCT01218126|144350200|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.0||||0.968|TWO_SIDED|95.0|-39.0|38.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Pre-Bronchodilator FEV1 for Placebo versus Losmapimod 2.5 mg at Week 4||38|-39|0.968
72419553|NCT01218126|144350200|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-7.0||||0.715|TWO_SIDED|95.0|-45.0|31.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Pre-Bronchodilator FEV1 Placebo versus Losmapimod 7.5 mg at Week 4||31|-45|0.715
72419554|NCT01218126|144350200|SUPERIORITY_OR_OTHER||Mean Difference (Net)|28.0||||0.152|TWO_SIDED|95.0|-10.0|66.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Pre-Bronchodilator FEV1 for Placebo versus Losmapimod 15 mg at Week 4||66|-10|0.152
72419555|NCT01218126|144350200|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.0||||0.922|TWO_SIDED|95.0|-45.0|40.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Pre-Bronchodilator FEV1 for Placebo versus Losmapimod 2.5 mg at Week 8||40|-45|0.922
72419556|NCT01218126|144350200|SUPERIORITY_OR_OTHER||Mean Difference (Net)|8.0||||0.694|TWO_SIDED|95.0|-34.0|50.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Pre-Bronchodilator FEV1 for Placebo versus Losmapimod 7.5 mg at Week 8||50|-34|0.694
72419557|NCT01218126|144350200|SUPERIORITY_OR_OTHER||Mean Difference (Net)|37.0||||0.094|TWO_SIDED|95.0|-6.3|79.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Pre-Bronchodilator FEV1 for Placebo versus Losmapimod 15 mg at Week 8||79|-6.3|0.094
72419558|NCT01218126|144350200|SUPERIORITY_OR_OTHER||Mean Difference (Net)|16.0||||0.456|TWO_SIDED|95.0|-26.0|58.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Pre-Bronchodilator FEV1 for Placebo versus Losmapimod 2.5 mg at Week 12||58|-26|0.456
72613281|NCT00879658|144755143|SUPERIORITY|Pairwise comparison of treatments are based on a negative binomial GEE regression model accounting for repeated measures on each patient, adjusted for baseline number of Gd-enhanced T1 lesions and treatment group x month (the month number of each lesion count measurement) interaction, using the log link.|lesion ratio|0.504||||0.169|TWO_SIDED|95.0|0.19|1.337||p-value corresponds to the lesion ratio and 95% CI of lesion ratio for active treatment in comparison to placebo.|Regression, Logistic|||||1.337|0.190|0.169
72613282|NCT00879658|144755144|SUPERIORITY|Pairwise comparison of treatments are based on a negative binomial GEE regression model accounting for repeated measures on each patient, adjusted for baseline number of Gd-enhanced T1 lesions and treatment group x month (the month number of each lesion count measurement) interaction, using the log link.|lesion ratio|0.214|||<|0.001|TWO_SIDED|95.0|0.091|0.499||p-value corresponds to the lesion ratio and 95% CI of lesion ratio for active treatment in comparison to placebo.|Regression, Logistic|||||0.499|0.091|<0.001
72419559|NCT01218126|144350200|SUPERIORITY_OR_OTHER||Mean Difference (Net)|20.0||||0.355|TWO_SIDED|95.0|-22.0|61.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Pre-Bronchodilator FEV1 for Placebo versus Losmapimod 7.5 mg at Week 12||61|-22|0.355
72419560|NCT01218126|144350200|SUPERIORITY_OR_OTHER||Mean Difference (Net)|49.0||||0.023|TWO_SIDED|95.0|6.7|91.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Pre-Bronchodilator FEV1 for Placebo versus Losmapimod 15 mg at Week 12||91|6.7|0.023
72419561|NCT01218126|144350200|SUPERIORITY_OR_OTHER||Mean Difference (Net)|22.0||||0.32|TWO_SIDED|95.0|-21.0|65.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Pre-Bronchodilator FEV1 for Placebo versus Losmapimod 2.5 mg at Week 16||65|-21|0.320
72419562|NCT01218126|144350200|SUPERIORITY_OR_OTHER||Mean Difference (Net)|24.0||||0.267|TWO_SIDED|95.0|-19.0|67.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Pre-Bronchodilator FEV1 for Placebo versus Losmapimod 7.5 mg at Week 16||67|-19|0.267
72419563|NCT01218126|144350200|SUPERIORITY_OR_OTHER||Mean Difference (Net)|24.0||||0.289|TWO_SIDED|95.0|-20.0|67.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Pre-Bronchodilator FEV1 for Placebo versus Losmapimod 15 mg at Week 16||67|-20|0.289
72419564|NCT01218126|144350200|SUPERIORITY_OR_OTHER||Mean Difference (Net)|6.0||||0.786|TWO_SIDED|95.0|-37.0|49.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Pre-Bronchodilator FEV1 for Placebo versus Losmapimod 2.5 mg at Week 20||49|-37|0.786
72419565|NCT01218126|144350200|SUPERIORITY_OR_OTHER||Mean Difference (Net)|33.0||||0.134|TWO_SIDED|95.0|-10.0|76.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Pre-Bronchodilator FEV1 for Placebo versus Losmapimod 7.5 mg at Week 20||76|-10|0.134
72419566|NCT01218126|144350200|SUPERIORITY_OR_OTHER||Mean Difference (Net)|29.0||||0.191|TWO_SIDED|95.0|-15.0|74.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Pre-Bronchodilator FEV1 for Placebo versus Losmapimod 15 mg at Week 20||74|-15|0.191
72613283|NCT00879658|144755144|SUPERIORITY|Pairwise comparison of treatments are based on a negative binomial GEE regression model accounting for repeated measures on each patient, adjusted for baseline number of Gd-enhanced T1 lesions and treatment group x month (the month number of each lesion count measurement) interaction, using the log link.|lesion ratio|0.24||||0.018|TWO_SIDED|95.0|0.074|0.779||p-value corresponds to the lesion ratio and 95% CI of lesion ratio for active treatment in comparison to placebo.|Regression, Logistic|||||0.779|0.074|0.018
72613284|NCT00879658|144755144|SUPERIORITY|Pairwise comparison of treatments are based on a negative binomial GEE regression model accounting for repeated measures on each patient, adjusted for baseline number of Gd-enhanced T1 lesions and treatment group x month (the month number of each lesion count measurement) interaction, using the log link.|lesion ratio|0.231||||0.006|TWO_SIDED|95.0|0.081|0.653||p-value corresponds to the lesion ratio and 95% CI of lesion ratio for active treatment in comparison to placebo.|Regression, Logistic|||||0.653|0.081|0.006
72613285|NCT04530344|144755191|SUPERIORITY||Hazard Ratio (HR)|0.422||||0.0414|TWO_SIDED|95.0|0.18|0.99|||Log Rank|The p-value was based on the log-rank test stratified by randomization stratification factor between treatment and vehicle.||Cox regression model stratified by stratification factor (treatment assignment in the parent studies) was conducted to compare the difference in hazard rate between treatment and vehicle.||0.990|0.180|0.0414
72613286|NCT04530344|144755192|SUPERIORITY||Hazard Ratio (HR)|0.316||||0.0003|TWO_SIDED|95.0|0.165|0.606|||Log Rank|The p-value was based on the log-rank test stratified by randomization stratification factor between treatment and vehicle.||Cox regression model stratified by stratification factor (treatment assignment in the parent studies) was conducted to compare the difference in hazard rate between treatment and vehicle.||0.606|0.165|0.0003
72613287|NCT00764517|144755254|OTHER||Hazard Ratio (HR)|0.33||||0.002|TWO_SIDED|95.0|0.16|0.69|||Log Rank|||||0.69|0.16|0.002
72613288|NCT00764517|144755255|OTHER||Hazard Ratio (HR)|0.42||||0.011|TWO_SIDED|95.0|0.21|0.84|||Log Rank|||||0.84|0.21|0.011
72613289|NCT00621530|144755273|SUPERIORITY||Median Difference (Final Values)|0.0|||=|0.94|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Power calculation assumed that all subjects would have an area of hypersensitivity surrounding the wound at 48 hours. We found that only 1 subject in the placebo group and 3 subjects in the ketorolac group had non-zero areas of hypersensitivity.||||=0.94
72613290|NCT00621530|144755274|SUPERIORITY||||||=|0.78|||||||ANOVA|Repeated measures ANOVA||||||=0.78
72613291|NCT00621530|144755275|SUPERIORITY||||||=|0.87|||||||ANOVA|Repeated measures ANOVA||||||=0.87
72613292|NCT00621530|144755276|SUPERIORITY||||||=|0.66|||||||ANOVA|Repeated measures ANOVA||||||=0.66
72613293|NCT00621530|144755277|SUPERIORITY||||||=|0.83|||||||ANOVA|Repeated measures ANOVA||||||=0.83
72613294|NCT03813654|144755278|OTHER|Mixed model analysis with post-hoc tests.|Mean Difference (Final Values)|90.0|STANDARD_DEVIATION|68.7|<|0.05|TWO_SIDED|||||A priori threshold was \<0.05.|Mixed Models Analysis||This is the difference between the control and 8-h Free Sleep Group.|||||<0.05
72613295|NCT03813654|144755283|SUPERIORITY|||||||0.09||||||The groups had unequal variances, so we adjusted for unequal variances when doing the t-test. The a priori threshold for statistical significance was p\<0.05.|t-test, 1 sided|Adjusted for unequal variances between the two groups.||We compared the PVT taken at the start of the final night shift between Group B and those in Group C who slept in the morning and had complete data. Our hypothesis was that Group B would have faster RTs.||||0.09
72613296|NCT01208051|144755301|SUPERIORITY|||||||0.26||||||p-value is stratified by randomization factors.|Log Rank|The conditional power was 7.8%, reaching the futility boundary of \<15%. Patients on the combination arm were then crossed over to cediranib alone.||||||0.26
72613297|NCT01208051|144755302|SUPERIORITY|||||||0.36|||||||Log Rank|||||||0.36
72613298|NCT01208051|144755304|SUPERIORITY|||||||0.8|||||||Log Rank|||||||0.80
72613299|NCT01208051|144755305|SUPERIORITY|||||||0.83|||||||Wilcoxon (Mann-Whitney)|||||||0.83
72613300|NCT00973973|144755309|SUPERIORITY||LS Mean Difference|-0.24|STANDARD_ERROR_OF_MEAN|0.107||0.0262|TWO_SIDED|95.0|-0.45|-0.03|||ANCOVA|Analysis of covariance (ANCOVA) model including baseline value as a covariate.||Comparison of Change from Baseline at Week 4||-0.03|-0.45|0.0262
72613301|NCT00973973|144755309|SUPERIORITY||LS Mean Difference|-0.76|STANDARD_ERROR_OF_MEAN|0.152|<|0.0001|TWO_SIDED|95.0|-1.06|-0.46|||ANCOVA|Analysis of covariance (ANCOVA) model, including baseline value as a covariate.||Comparison of change from baseline at week 8||-0.46|-1.06|< 0.0001
72613302|NCT00973973|144755311|SUPERIORITY||LS Mean Difference|-0.21|STANDARD_ERROR_OF_MEAN|0.086||0.0163|TWO_SIDED|95.0|-0.38|-0.04|||ANCOVA|ANCOVA model including baseline value as a covariate.||Comparison of change from baseline at week 4||-0.04|-0.38|0.0163
72613303|NCT00973973|144755311|SUPERIORITY||LS Mean Difference|-0.28|STANDARD_ERROR_OF_MEAN|0.101||0.0066|TWO_SIDED|95.0|-0.48|-0.08|||ANCOVA|ANCOVA model including baseline value as a covariate.||Comparison of change from baseline at week 8||-0.08|-0.48|0.0066
72613304|NCT00973973|144755313|SUPERIORITY||LS Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.082||0.0089|TWO_SIDED|95.0|-0.38|-0.06|||ANCOVA|ANCOVA model including baseline value as a covariate.||Comparison of change from baseline at week 4||-0.06|-0.38|0.0089
72419567|NCT01218126|144350200|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.0||||0.852|TWO_SIDED|95.0|-38.0|46.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Pre-Bronchodilator FEV1 for Placebo versus Losmapimod 2.5 mg at Week 24||46|-38|0.852
72327014|NCT00889707|144177662|SUPERIORITY_OR_OTHER|||||||0.047||||||ANCOVA model with terms for treatment group, baseline total IPSS, baseline prostate volume, and baseline Qmax.|ANCOVA|Model with terms for treatment group, baseline total IPSS, baseline prostate volume, and baseline Qmax.||||||0.047
72419568|NCT01218126|144350200|SUPERIORITY_OR_OTHER||Mean Difference (Net)|18.0||||0.397|TWO_SIDED|95.0|-24.0|60.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Pre-Bronchodilator FEV1 for Placebo versus Losmapimod 7.5 mg at Week 24||60|-24|0.397
72419569|NCT01218126|144350200|SUPERIORITY_OR_OTHER||Mean Difference (Net)|15.0||||0.494|TWO_SIDED|95.0|-28.0|58.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Pre-Bronchodilator FEV1 for Placebo versus Losmapimod 15 mg at Week 24||58|-28|0.494
72419570|NCT01218126|144350200|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.0||||0.807|TWO_SIDED|95.0|-31.0|40.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Post-Bronchodilator FEV1 for Placebo versus Losmapimod 7.5 mg at Week 4||40|-31|0.807
72419571|NCT01218126|144350200|SUPERIORITY_OR_OTHER||Mean Difference (Net)|16.0||||0.386|TWO_SIDED|95.0|-20.0|51.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Post-Bronchodilator FEV1 for Placebo versus Losmapimod 7.5 mg at Week 4||51|-20|0.386
72327015|NCT02185534|144177663|NON_INFERIORITY_OR_EQUIVALENCE|The analysis was conducted using an analysis of variance (ANOVA) including fixed effects for treatment, sequence, period and subject within sequence. All pharmacokinetic parameters were log-transformed prior to analysis. Bioequivalence was concluded, when the 90% confidence interval (CI) for the geometric LS mean ratios were fully contained within the predefined equivalence limits of 0.80 to 1.25|Geometric mean ratio|104.43|||||TWO_SIDED|90.0|92.27|118.19|||||Geometric mean ratio is calculated as A/B, where A= European clopidogrel and B=Japanese clopidogrel|||118.19|92.27|
72419572|NCT01218126|144350200|SUPERIORITY_OR_OTHER||Mean Difference (Net)|31.0||||0.089|TWO_SIDED|95.0|-4.8|67.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Post-Bronchodilator FEV1 for Placebo versus Losmapimod 15 mg at Week 4||67|-4.8|0.089
72419573|NCT01218126|144350200|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.0||||0.958|TWO_SIDED|95.0|-45.0|43.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Post-Bronchodilator FEV1 for Placebo versus Losmapimod 2.5 mg at Week 8||43|-45|0.958
72419574|NCT01218126|144350200|SUPERIORITY_OR_OTHER||Mean Difference (Net)|7.0||||0.766|TWO_SIDED|95.0|-37.0|50.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Post-Bronchodilator FEV1 for Placebo versus Losmapimod 7.5 mg at Week 8||50|-37|0.766
72419575|NCT01218126|144350200|SUPERIORITY_OR_OTHER||Mean Difference (Net)|43.0||||0.06||95.0|-1.7|87.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Post-Bronchodilator FEV1 for Placebo versus Losmapimod 15 mg at Week 8||87|-1.7|0.060
72419576|NCT01218126|144350200|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-9.0||||0.678|TWO_SIDED|95.0|-53.0|35.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Post-Bronchodilator FEV1 for Placebo versus Losmapimod 2.5 mg at Week 12||35|-53|0.678
72419577|NCT01218126|144350200|SUPERIORITY_OR_OTHER||Mean Difference (Net)|11.0||||0.636|TWO_SIDED|95.0|-33.0|54.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Post-Bronchodilator FEV1 for Placebo versus Losmapimod 7.5 mg at Week 12||54|-33|0.636
72419578|NCT01218126|144350200|SUPERIORITY_OR_OTHER||Mean Difference (Net)|38.0||||0.094|TWO_SIDED|95.0|-6.5|83.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Post-Bronchodilator FEV1 for Placebo versus Losmapimod 15 mg at Week 12||83|-6.5|0.094
72419579|NCT01218126|144350200|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-6.0||||0.772|TWO_SIDED|95.0|-49.0|37.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Post-Bronchodilator FEV1 for Placebo versus Losmapimod 2.5 mg at Week 16||37|-49|0.772
72419580|NCT01218126|144350200|SUPERIORITY_OR_OTHER||Mean Difference (Net)|19.0||||0.387|TWO_SIDED|95.0|-24.0|61.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Post-Bronchodilator FEV1 for Placebo versus Losmapimod 7.5 mg at Week 16||61|-24|0.387
72419581|NCT01218126|144350200|SUPERIORITY_OR_OTHER||Mean Difference (Net)|26.0||||0.243|TWO_SIDED|95.0|-18.0|69.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Post-Bronchodilator FEV1 for Placebo versus Losmapimod 15 mg at Week 16||69|-18|0.243
72419582|NCT01218126|144350200|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-19.0||||0.398|TWO_SIDED|95.0|-62.0|25.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Post-Bronchodilator FEV1 for Placebo versus Losmapimod 2.5 mg at Week 20||25|-62|0.398
72419583|NCT01218126|144350200|SUPERIORITY_OR_OTHER||Mean Difference (Net)|27.0||||0.214|TWO_SIDED|95.0|-16.0|70.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Post-Bronchodilator FEV1 for Placebo versus Losmapimod 7.5 mg at Week 20||70|-16|0.214
72419584|NCT01218126|144350200|SUPERIORITY_OR_OTHER||Mean Difference (Net)|14.0||||0.526|TWO_SIDED|95.0|-30.0|58.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Post-Bronchodilator FEV1 for Placebo versus Losmapimod 15 mg at Week 20||58|-30|0.526
72419585|NCT01218126|144350200|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-9.0||||0.671|TWO_SIDED|95.0|-53.0|34.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Post-Bronchodilator FEV1 for Placebo versus Losmapimod 2.5 mg at Week 24||34|-53|0.671
72419586|NCT01218126|144350200|SUPERIORITY_OR_OTHER||Mean Difference (Net)|20.0||||0.355|TWO_SIDED|95.0|-23.0|64.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Post-Bronchodilator FEV1 for Placebo versus Losmapimod 7.5 mg at Week 24||64|-23|0.355
72419587|NCT01218126|144350200|SUPERIORITY_OR_OTHER||Mean Difference (Net)|6.0||||0.781|TWO_SIDED|95.0|-38.0|50.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Post-Bronchodilator FEV1 for Placebo versus Losmapimod 15 mg at Week 24||50|-38|0.781
72613305|NCT00973973|144755313|SUPERIORITY||LS Mean Difference|-0.33|STANDARD_ERROR_OF_MEAN|0.1||0.0011|TWO_SIDED|95.0|-0.53|-0.14|||ANCOVA|ANCOVA model including baseline value as a covariate.||Comparison of change from baseline at week 8||-0.14|-0.53|0.0011
72613306|NCT00973973|144755315|SUPERIORITY||LS Mean Difference|-0.27|STANDARD_ERROR_OF_MEAN|0.127||0.036|TWO_SIDED|95.0|-0.52|-0.02|||ANCOVA|ANCOVA model including baseline value as a covariate.||Comparison of change form baseline at week 4||-0.02|-0.52|0.0360
72327016|NCT02185534|144177663|NON_INFERIORITY_OR_EQUIVALENCE|Geometric mean ratio is calculated as A/C, where A= European clopidogrel and C=US clopidogrel|Geometric mean ratio|97.19|||||TWO_SIDED|90.0|81.12|116.45|||||Geometric mean ratio is calculated as A/C, where A= European clopidogrel and C=US clopidogrel|The analysis was conducted using an analysis of variance (ANOVA) including fixed effects for treatment, sequence, period and subject within sequence. All pharmacokinetic parameters were log-transformed prior to analysis. Bioequivalence was concluded, when the 90% confidence interval (CI) for the geometric LS mean ratios were fully contained within the predefined equivalence limits of 0.80 to 1.25||116.45|81.12|
72419588|NCT01218126|144350201|SUPERIORITY_OR_OTHER||Mean Difference (Net)|13.0||||0.742|TWO_SIDED|95.0|-66.0|93.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Pre-Bronchodilator FVC for Placebo versus Losmapimod 2.5 mg at Week 4||93|-66|0.742
72419589|NCT01218126|144350201|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-30.0||||0.446|TWO_SIDED|95.0|-109.0|48.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Pre-Bronchodilator FVC for Placebo versus Losmapimod 7.5 mg at Week 4||48|-109|0.446
72419590|NCT01218126|144350201|SUPERIORITY_OR_OTHER||Mean Difference (Net)|57.0||||0.157|TWO_SIDED|95.0|-22.0|137.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Pre-Bronchodilator FVC for Placebo versus Losmapimod 15 mg at Week 4||137|-22|0.157
72419591|NCT01218126|144350201|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-9.0||||0.826|TWO_SIDED|95.0|-93.0|74.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Pre-Bronchodilator FVC for Placebo versus Losmapimod 2.5 mg at Week 8||74|-93|0.826
72613307|NCT00973973|144755315|SUPERIORITY||LS Mean Difference|-0.38|STANDARD_ERROR_OF_MEAN|0.137||0.007|TWO_SIDED|95.0|-0.65|-0.11|||ANCOVA|ANCOVA model including baseline value as a covariate.||Comparison of change from baseline at week 8||-0.11|-0.65|0.0070
72613308|NCT00973973|144755321|SUPERIORITY||LS Mean Difference|-9.84|STANDARD_ERROR_OF_MEAN|3.939||0.0137|TWO_SIDED|95.0|-17.63|-2.05|||ANCOVA|ANCOVA model including baseline value as a covariate.||Comparison of change from baseline at week 4||-2.05|-17.63|0.0137
72613309|NCT00973973|144755321|SUPERIORITY||LS Mean Difference|-12.44|STANDARD_ERROR_OF_MEAN|3.913||0.0019|TWO_SIDED|95.0|-20.19|-4.7|||ANCOVA|ANCOVA model including baseline value as a covariate.||Comparison of change from baseline at week 8||-4.70|-20.19|0.0019
72613310|NCT00973973|144755323|SUPERIORITY||LS Mean Difference|-6.21|STANDARD_ERROR_OF_MEAN|2.728||0.0244|TWO_SIDED|95.0|-11.61|-0.81|||ANCOVA|ANCOVA model including baseline value as a covariate.||Comparison of change from baseline at week 4||-0.81|-11.61|0.0244
72613311|NCT00973973|144755323|SUPERIORITY||LS Mean Difference|-6.35|STANDARD_ERROR_OF_MEAN|2.549||0.0141|TWO_SIDED|95.0|-11.39|-1.3|||ANCOVA|ANCOVA model including baseline value as a covariate.||Comparison of change from baseline at week 8||-1.30|-11.39|0.0141
72613312|NCT00973973|144755325|SUPERIORITY||LS Mean Difference|-3.12|STANDARD_ERROR_OF_MEAN|1.821||0.0893|TWO_SIDED|95.0|-6.72|0.49|||ANCOVA|ANCOVA model including baseline value as a covariate.||Comparison of change from baseline at week 4||0.49|-6.72|0.0893
72613313|NCT00973973|144755325|SUPERIORITY||LS Mean Difference|-3.52|STANDARD_ERROR_OF_MEAN|1.938||0.072|TWO_SIDED|95.0|-7.35|0.32|||ANCOVA|ANCOVA model including baseline value as a covariate.||Comparison of change from baseline at week 8||0.32|-7.35|0.0720
72327017|NCT02185534|144177664|NON_INFERIORITY_OR_EQUIVALENCE|The analysis was conducted using an analysis of variance (ANOVA) including fixed effects for treatment, sequence, period and subject within sequence. All pharmacokinetic parameters were log-transformed prior to analysis. Bioequivalence was concluded, when the 90% confidence interval (CI) for the geometric LS mean ratios were fully contained within the predefined equivalence limits of 0.80 to 1.25.|Geometric mean ratio|108.06|||||TWO_SIDED|90.0|95.46|122.33|||||Geometric mean ratio is calculated as A/B, where A= European clopidogrel and B=Japanese clopidogrel|||122.33|95.46|
72327018|NCT02185534|144177664|NON_INFERIORITY_OR_EQUIVALENCE|The analysis was conducted using an analysis of variance (ANOVA) including fixed effects for treatment, sequence, period and subject within sequence. All pharmacokinetic parameters were log-transformed prior to analysis. Bioequivalence was concluded, when the 90% confidence interval (CI) for the geometric LS mean ratios were fully contained within the predefined equivalence limits of 0.80 to 1.25.|Geometric mean ratio|105.79|||||TWO_SIDED|90.0|95.22|117.53|||||Geometric mean ratio is calculated as A/C, where A= European clopidogrel and C=US clopidogrel|||117.53|95.22|
72327019|NCT02185534|144177665|NON_INFERIORITY_OR_EQUIVALENCE|The analysis was conducted using an analysis of variance (ANOVA) including fixed effects for treatment, sequence, period and subject within sequence. All pharmacokinetic parameters were log-transformed prior to analysis. Bioequivalence was concluded, when the 90% confidence interval (CI) for the geometric LS mean ratios were fully contained within the predefined equivalence limits of 0.80 to 1.25.|Geometric mean ratio|93.94|||||TWO_SIDED|90.0|87.12|101.29|||||Geometric mean ratio is calculated as A/B, where A= European clopidogrel and B=Japanese clopidogrel|||101.29|87.12|
72327020|NCT02185534|144177665|NON_INFERIORITY_OR_EQUIVALENCE|The analysis was conducted using an analysis of variance (ANOVA) including fixed effects for treatment, sequence, period and subject within sequence. All pharmacokinetic parameters were log-transformed prior to analysis. Bioequivalence was concluded, when the 90% confidence interval (CI) for the geometric LS mean ratios were fully contained within the predefined equivalence limits of 0.80 to 1.25|Geometric mean ratio|92.03|||||TWO_SIDED|90.0|84.91|99.75|||||Geometric mean ratio is calculated as A/C, where A= European clopidogrel and C=US clopidogrel|||99.75|84.91|
72327021|NCT02041299|144177670|NON_INFERIORITY|Non-inferiority is demonstrated if the upper limit of the 96.01% confidence interval (CI) is less than or equal to 2 mg/g dw.|Mean Difference (Net)|0.26||||0.0399|TWO_SIDED|96.01|-0.97|1.48|||ANCOVA|||||1.48|-0.97|0.0399
72327022|NCT02041299|144177671|NON_INFERIORITY|Support for non-inferiority is demonstrated if the 96.01% CI contains zero (0)|Mean Difference (Net)|-0.000295||||0.0399|TWO_SIDED|96.01|-0.054247|0.053657|||ANCOVA|||Data for this measure were log-transformed.||0.053657|-0.054247|0.0399
72327023|NCT02041299|144177672|NON_INFERIORITY|Support for non-inferiority of deferiprone to deferoxamine in serum ferritin is demonstrated if the 96.01% CI contains zero (0)|Mean Difference (Net)|375.07||||0.0399|TWO_SIDED|96.01|-260.63|1010.76|||ANCOVA|||||1010.76|-260.63|0.0399
72613314|NCT00973973|144755327|SUPERIORITY||LS Mean Difference|-2.26|STANDARD_ERROR_OF_MEAN|0.505|<|0.0001|TWO_SIDED|95.0|-3.26|-1.26|||ANCOVA|ANCOVA model including baseline value as a covariate.||Comparison of the change from baseline in CPSSS total score||-1.26|-3.26|< 0.0001
72613315|NCT00973973|144755327|SUPERIORITY||LS Mean Difference|-1.05|STANDARD_ERROR_OF_MEAN|0.18|<|0.0001|TWO_SIDED|95.0|-1.41|-0.69|||ANCOVA|ANCOVA model including baseline value as a covariate.||Comparison of change from baseline in CPSSS component of dysmenorrhea score||-0.69|-1.41|< 0.0001
72613316|NCT00973973|144755327|SUPERIORITY||LS Mean Difference|-0.36|STANDARD_ERROR_OF_MEAN|0.143||0.0139|TWO_SIDED|95.0|-0.64|-0.07|||ANCOVA|ANCOVA model including baseline value as a covariate.||Comparison of change from baseline in CPSSS component of non-menstrual pelvic pain score||-0.07|-0.64|0.0139
72327024|NCT02041299|144177673|SUPERIORITY|Comparison of treatment groups on change in score on SF-36 Physical Summary||||||0.9214|||||||ANCOVA|||||||0.9214
72327025|NCT02041299|144177673|SUPERIORITY|||||||0.1174|||||||ANCOVA|||Comparison of treatment groups on change in score on SF-36 Mental Summary||||0.1174
72327026|NCT02041299|144177673|SUPERIORITY|||||||0.6488|||||||ANCOVA|||Comparison of treatment groups on change in score on CHQ-PF50 Physical Summary||||0.6488
72327027|NCT02041299|144177673|SUPERIORITY|||||||0.5915|||||||ANCOVA|||Comparison of treatment groups on change in score on CHQ-PF50 Psychosocial Summary||||0.5915
72613317|NCT00973973|144755327|SUPERIORITY||LS Mean Difference|-0.28|STANDARD_ERROR_OF_MEAN|0.173||0.1052|TWO_SIDED|95.0|-0.63|0.06|||ANCOVA|ANCOVA model including baseline value as a covariate.||Comparison of change from baseline in CPSSS component of dyspareunia score||0.06|-0.63|0.1052
72419592|NCT01218126|144350201|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-12.0||||0.773||95.0|-95.0|70.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Pre-Bronchodilator FVC for Placebo versus Losmapimod 7.5 mg at Week 8||70|-95|0.773
72419593|NCT01218126|144350201|SUPERIORITY_OR_OTHER||Mean Difference (Net)|47.0||||0.277|TWO_SIDED|95.0|-38.0|131.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Pre-Bronchodilator FVC for Placebo versus Losmapimod 15 mg at Week 8||131|-38|0.277
72419594|NCT01218126|144350201|SUPERIORITY_OR_OTHER||Mean Difference (Net)|45.0||||0.319|TWO_SIDED|95.0|-43.0|132.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Pre-Bronchodilator FVC for Placebo versus Losmapimod 2.5 mg at Week 12||132|-43|0.319
72419595|NCT01218126|144350201|SUPERIORITY_OR_OTHER||Mean Difference (Net)|16.0||||0.716|TWO_SIDED|95.0|-71.0|103.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Pre-Bronchodilator FVC for Placebo versus Losmapimod 7.5 mg at Week 12||103|-71|0.716
72419596|NCT01218126|144350201|SUPERIORITY_OR_OTHER||Mean Difference (Net)|75.0||||0.098|TWO_SIDED|95.0|-14.0|163.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Pre-Bronchodilator FVC for Placebo versus Losmapimod 15 mg at Week 12||163|-14|0.098
72419597|NCT01218126|144350201|SUPERIORITY_OR_OTHER||Mean Difference (Net)|10.0||||0.832|TWO_SIDED|95.0|-80.0|100.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Pre-Bronchodilator FVC for Placebo versus Losmapimod 2.5 mg at Week 16||100|-80|0.832
72419598|NCT01218126|144350201|SUPERIORITY_OR_OTHER||Mean Difference (Net)|25.0||||0.579|TWO_SIDED|95.0|-64.0|114.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Pre-Bronchodilator FVC for Placebo versus Losmapimod 7.5 mg at Week 16||114|-64|0.579
72419599|NCT01218126|144350201|SUPERIORITY_OR_OTHER||Mean Difference (Net)|42.0||||0.369|TWO_SIDED|95.0|-49.0|133.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Pre-Bronchodilator FVC for Placebo versus Losmapimod 15 mg at Week 16||133|-49|0.369
72419600|NCT01218126|144350201|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-32.0||||0.487|TWO_SIDED|95.0|-121.0|58.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Pre-Bronchodilator FVC for Placebo versus Losmapimod 2.5 mg at Week 20||58|-121|0.487
72419601|NCT01218126|144350201|SUPERIORITY_OR_OTHER||Mean Difference (Net)|6.0||||0.887|TWO_SIDED|95.0|-82.0|95.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Pre-Bronchodilator FVC for Placebo versus Losmapimod 7.5 mg at Week 20||95|-82|0.887
72419602|NCT01218126|144350201|SUPERIORITY_OR_OTHER||Mean Difference (Net)|32.0||||0.486|TWO_SIDED|95.0|-59.0|123.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Pre-Bronchodilator FVC for Placebo versus Losmapimod 15 mg at Week 20||123|-59|0.486
72327028|NCT02389465|144177674|OTHER|||||||0.44|||||||t-test, 2 sided|||IL6 levels in healthy controls pre- and post-treatment compared using a paired t-test||||.44
72419603|NCT01218126|144350201|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-24.0||||0.604||95.0|-113.0|66.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Pre-Bronchodilator FVC for Placebo versus Losmapimod 2.5 mg at Week 24||66|-113|0.604
72419604|NCT01218126|144350201|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-7.0||||0.872|TWO_SIDED|95.0|-97.0|82.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Pre-Bronchodilator FVC for Placebo versus Losmapimod 7.5 mg at Week 24||82|-97|0.872
72419605|NCT01218126|144350201|SUPERIORITY_OR_OTHER||Mean Difference (Net)|43.0||||0.355|TWO_SIDED|95.0|-48.0|134.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Pre-Bronchodilator FVC for Placebo versus Losmapimod 15 mg at Week 24||134|-48|0.355
72419606|NCT01218126|144350201|SUPERIORITY_OR_OTHER||Mean Difference (Net)|8.0||||0.839|TWO_SIDED|95.0|-65.0|80.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Post-Bronchodilator FVC for Placebo versus Losmapimod 2.5 mg at Week 4||80|-65|0.839
72327029|NCT02389465|144177674|OTHER|||||||0.11|||||||t-test, 2 sided|||IL6 levels in the placebo group pre- and post-treatment compared using a paired t-test||||.11
72327030|NCT02389465|144177674|OTHER|||||||0.42|||||||t-test, 2 sided|||IL6 levels in the escitalopram group pre- and post-treatment compared using a paired t-test||||.42
72327031|NCT02389465|144177674|OTHER|||||||0.49|||||||t-test, 2 sided|||IL-6 levels in the escitalopram + celecoxib group pre- and post-treatment compared using a paired t-tes||||.49
72327032|NCT02389465|144177674|OTHER|||||||0.23|||||||t-test, 2 sided|||IL6 levels at completion of study compared between all MDD groups (placebo, escitalopram, and escitalopram + celecoxib) and the healthy control group||||.23
72613318|NCT00973973|144755327|SUPERIORITY||LS Mean Difference|-0.39|STANDARD_ERROR_OF_MEAN|0.143||0.0081|TWO_SIDED|95.0|-0.67|-0.1|||ANCOVA|ANCOVA model including baseline value as a covariate.||Comparison of change from baseline in CPSSS component of pelvic tenderness score||-0.10|-0.67|0.0081
72613319|NCT00973973|144755327|SUPERIORITY||LS Mean Difference|-0.29|STANDARD_ERROR_OF_MEAN|0.125||0.024|TWO_SIDED|95.0|-0.53|-0.04|||ANCOVA|ANCOVA model including baseline value as a covariate.||Comparison of change from baseline in CPSSS component of induration score||-0.04|-0.53|0.0240
72613320|NCT00973973|144755329|SUPERIORITY||LS Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.23||0.0012|TWO_SIDED|95.0|-1.2|-0.3|||ANOVA|||Comparison of Patient Global Impression of Change at week 4||-0.3|-1.2|0.0012
72613321|NCT00973973|144755329|SUPERIORITY||LS Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.26||0.0002|TWO_SIDED|95.0|-1.5|-0.5|||ANOVA|||Comparison of Patient Global Impression of Change at week 8||-0.5|-1.5|0.0002
72613322|NCT00973973|144755331|SUPERIORITY||Difference|19.4||||0.0136|TWO_SIDED|95.0|4.4|34.4|||Pearson chi-squared|||Comparison of response rates at week 4||34.4|4.4|0.0136
72613323|NCT00973973|144755331|SUPERIORITY||Difference|30.2||||0.0007|TWO_SIDED|95.0|13.6|46.7|||Pearson chi-squared|||Comparison of response rates at week 8||46.7|13.6|0.0007
72613324|NCT00671060|144755337|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.682|||<|0.05|TWO_SIDED|95.0|||||Chi-squared|||Rates of success were compared across study arms. The study was a separate, non-comparative efficacy study. In order to have 80% power (alpha=.05) to demonstrate that each misoprostol regimen was 95%, ± 5%, effective, we enrolled 73 women in each arm of the study, or 146 women total. The sample size also provided 80% power (alpha=.05) to detect a significant difference between treatments should 200μg prove 98% effective and 100μg prove 88% effective.||||<0.05
72613325|NCT02832037|144755366|OTHER|Mixed-effects Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod. MMRM included fixed, categorical factors of treatment, analysis visit as repeated measures per subject, and treatment by analysis visit interaction, continuous fixed covariate of baseline value and baseline value by analysis visit interaction, subject as random effect, covariance structure= Unstructured.||||||0.0145||||||Adjusted for multiplicity.|MCP-Mod linear model fit|||A flat vs. non-flat dose-response relationship across the 4 doses of BI 425809 and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 6 different plausible dose-response patterns (linear, linear in log, Emax, Sigmoid Emax, logistic, and beta) while protecting the overall probability of type I error (one-sided alpha of 0.05).||||0.0145
72613326|NCT02832037|144755366|OTHER|Mixed-effects Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod. MMRM included fixed, categorical factors of treatment, analysis visit as repeated measures per subject, and treatment by analysis visit interaction, continuous fixed covariate of baseline value and baseline value by analysis visit interaction, subject as random effect, covariance structure= Unstructured.||||||0.0148||||||Adjusted for multiplicity.|MCP-Mod linear in log model fit|||A flat vs. non-flat dose-response relationship across the 4 doses of BI 425809 and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 6 different plausible dose-response patterns (linear, linear in log, Emax, Sigmoid Emax, logistic, and beta) while protecting the overall probability of type I error (one-sided alpha of 0.05).||||0.0148
72613327|NCT02832037|144755366|OTHER|Mixed-effects Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod. MMRM included fixed, categorical factors of treatment, analysis visit as repeated measures per subject, and treatment by analysis visit interaction, continuous fixed covariate of baseline value and baseline value by analysis visit interaction, subject as random effect, covariance structure= Unstructured.||||||0.0089||||||Adjusted for multiplicity.|MCP-Mod Emax model fit|Model assumption: 20% of the maximum effect is achieved at 2 mg of BI 425809 .||A flat vs. non-flat dose-response relationship across the 4 doses of BI 425809 and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 6 different plausible dose-response patterns (linear, linear in log, Emax, Sigmoid Emax, logistic, and beta) while protecting the overall probability of type I error (one-sided alpha of 0.05).||||0.0089
72613328|NCT02832037|144755366|OTHER|Mixed-effects Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod. MMRM included fixed, categorical factors of treatment, analysis visit as repeated measures per subject, and treatment by analysis visit interaction, continuous fixed covariate of baseline value and baseline value by analysis visit interaction, subject as random effect, covariance structure= Unstructured.||||||0.0038||||||Adjusted for multiplicity.|MCP-Mod Sigmoid Emax model fit|Model assumption: 25% of the maximum effect is achieved at 5 mg and 75% of the maximum effect is achieved at 10 mg of BI 425809.||A flat vs. non-flat dose-response relationship across the 4 doses of BI 425809 and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 6 different plausible dose-response patterns (linear, linear in log, Emax, Sigmoid Emax, logistic, and beta) while protecting the overall probability of type I error (one-sided alpha of 0.05).||||0.0038
72613329|NCT02832037|144755366|OTHER|Mixed-effects Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod. MMRM included fixed, categorical factors of treatment, analysis visit as repeated measures per subject, and treatment by analysis visit interaction, continuous fixed covariate of baseline value and baseline value by analysis visit interaction, subject as random effect, covariance structure= Unstructured.||||||0.0085||||||Adjusted for multiplicity.|MCP-Mod logistic model fit|Model assumption: 10% of the maximum effect is achieved at 5 mg and 50% of the maximum effect is achieved at 10 mg of BI 425809.||A flat vs. non-flat dose-response relationship across the 4 doses of BI 425809 and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 6 different plausible dose-response patterns (linear, linear in log, Emax, Sigmoid Emax, logistic, and beta) while protecting the overall probability of type I error (one-sided alpha of 0.05).||||0.0085
72327033|NCT02389465|144177675|SUPERIORITY|||||||0.003|||||||Wilcoxon (Mann-Whitney)|||MADRS scores at the final visit compared between the healthy control and escitalopram + celecoxib groups||||.003
72327034|NCT02389465|144177675|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||MADRS scores at the final visit compared between the healthy control and escitalopram groups||||<.001
72327035|NCT02389465|144177675|SUPERIORITY|||||||0.034|||||||Wilcoxon (Mann-Whitney)|||MADRS scores at the final visit compared between the healthy control and placebo groups||||.034
72327036|NCT02389465|144177675|SUPERIORITY|||||||0.03|||||||ANCOVA|||MADRS scores at the final visit compared between the placebo groups and all groups receiving escitalopram (both with and without celecoxib)||||.03
72327037|NCT02389465|144177676|OTHER|||||||0.29|||||||t-test, 2 sided|||IL10 levels in healthy controls pre- and post-treatment compared using a paired t-test||||.29
72327038|NCT02389465|144177676|OTHER|||||||0.19|||||||t-test, 2 sided|||IL10 levels in the placebo group pre- and post-treatment compared using a paired t-test||||.19
72327039|NCT02389465|144177676|OTHER|||||||0.5|||||||t-test, 2 sided|||IL10 levels in the escitalopram group pre- and post-treatment compared using a paired t-test||||.5
72327040|NCT02389465|144177676|OTHER|||||||0.55|||||||t-test, 2 sided|||IL10 levels in the escitalopram + celecoxib group pre- and post-treatment compared using a paired t-test||||.55
72613330|NCT02832037|144755366|OTHER|Mixed-effects Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod. MMRM included fixed, categorical factors of treatment, analysis visit as repeated measures per subject, and treatment by analysis visit interaction, continuous fixed covariate of baseline value and baseline value by analysis visit interaction, subject as random effect, covariance structure= Unstructured.||||||0.228||||||Adjusted for multiplicity.|MCP-Mod beta model fit|Assumption:75% of maximum (max) effect at 2mg, 87.5% of max effect at 5mg,25% of max effect at 25mg,max effect at 10mg BI 425809, scalar parameter=26.||A flat vs. non-flat dose-response relationship across the 4 doses of BI 425809 and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 6 different plausible dose-response patterns (linear, linear in log, Emax, Sigmoid Emax, logistic, and beta) while protecting the overall probability of type I error (one-sided alpha of 0.05).||||0.2280
72327041|NCT02389465|144177676|OTHER|||||||0.06|||||||t-test, 2 sided|||IL10 levels at completion of study compared between all MDD groups (placebo, escitalopram, and escitalopram + celecoxib) and the healthy control group||||.06
72327042|NCT00361972|144177721|SUPERIORITY_OR_OTHER|||||||0.03|||||||Wilcoxon (Mann-Whitney)|||||||0.03
72327043|NCT00361972|144177722|SUPERIORITY_OR_OTHER|||||||0.17|||||||Wilcoxon (Mann-Whitney)|||||||0.17
72327044|NCT00503425|144177724|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Change from baseline in mean DAS28 was analyzed using paired t-test for course 1.|t-test, 2 sided|||||||<0.0001
72327045|NCT00503425|144177724|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Change from baseline in mean DAS28 was analyzed using paired t-test for course 2.|t-test, 2 sided|||||||<0.0001
72327046|NCT00503425|144177724|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Change from baseline in mean DAS28 was analyzed using paired t-test for course 3.|t-test, 2 sided|||||||<0.0001
72327047|NCT00503425|144177724|SUPERIORITY_OR_OTHER|||||||0.0001|TWO_SIDED|||||Change from baseline in mean DAS28 was analyzed using paired t-test for course 4.|t-test, 2 sided|||||||0.0001
72327048|NCT03542266|144177735|OTHER||Proportion (percent)|75.0|||||TWO_SIDED|95.0|46.5|90.3|||||Exact (Clopper-Pearson) 95% confidence interval for complete response rate.|||90.3|46.5|
72327049|NCT00437268|144177738|SUPERIORITY_OR_OTHER_LEGACY|||||||0.431||||||The type 1 error rate was set at 0.20|Log Rank|||||||0.431
72327050|NCT00437268|144177739|SUPERIORITY_OR_OTHER_LEGACY|||||||0.593|||||||Fisher Exact|||||||0.593
72327051|NCT00437268|144177740|SUPERIORITY_OR_OTHER_LEGACY|||||||0.157|||||||Log Rank|||||||0.157
72327052|NCT00437268|144177741|SUPERIORITY_OR_OTHER_LEGACY|||||||0.539||||||Kaplan-Meier analysis was used for statistical analysis.|Log Rank|||||||0.539
72327053|NCT00437268|144177742|SUPERIORITY_OR_OTHER_LEGACY|||||||0.695|||||||Fisher Exact|||||||0.695
72327054|NCT00444925|144177744|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Comparison fesoterodine vs tolterodine ER performed only if statistical significance favoring fesoterodine achieved for fesoterodine vs placebo to preserve overall alpha level at 5%; pairwise comparison also performed for tolterodine ER vs placebo.|Van Elteren's Test|P-value based on Van Elteren's Test (a stratified Wilcoxon-Mann Whitney test) adjusted by baseline UUI quartile.||Treatment Difference Fesoterodine versus (vs) placebo at Week 12. Treatment effects estimated by Winsorized means (5% of the tails were censored, ie, replaced with the value at the fifth (5th) and ninety-fifth (95th) percentile, respectively).||||<0.0001
72327055|NCT00444925|144177744|SUPERIORITY_OR_OTHER|||||||0.0107||95.0||||Comparison fesoterodine vs tolterodine ER performed only if statistical significance favoring fesoterodine achieved for fesoterodine vs placebo to preserve overall alpha level at 5%; pairwise comparison also performed for tolterodine ER vs placebo.|Van Elteren's Test|P-value based on Van Elteren's Test (a stratified Wilcoxon-Mann Whitney test) adjusted by baseline UUI quartile.||Treatment Difference Tolterodine ER vs placebo at Week 12. Treatment effects estimated by Winsorized means (5% of the tails were censored, ie, replaced with the value at the 5th and 95th percentile, respectively).||||0.0107
72327056|NCT00444925|144177744|SUPERIORITY_OR_OTHER|||||||0.0172||95.0||||Comparison fesoterodine vs tolterodine ER performed only if statistical significance favoring fesoterodine achieved for fesoterodine vs placebo to preserve overall alpha level at 5%; pairwise comparison also performed for tolterodine ER vs placebo.|Van Elteren's Test|P-value based on Van Elteren's Test (a stratified Wilcoxon-Mann Whitney test) adjusted by baseline UUI quartile.||Treatment Difference Fesoterodine vs Tolterodine ER at Week 12. Treatment effects estimated by Winsorized means (5% of the tails were censored, ie, replaced with the value at the 5th and 95th percentile, respectively).||||0.0172
72327057|NCT00444925|144177745|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Van Elteren's Test|P-value based on Van Elteren's Test adjusted by baseline UUI quartile.||Treatment Difference Fesoterodine vs placebo at Week 1. Winsorized means (5% of the tails were censored, ie, replaced with the value at the 5th and 95th percentile, respectively).||||<0.0001
72419607|NCT01218126|144350201|SUPERIORITY_OR_OTHER||Mean Difference (Net)|12.0||||0.741|TWO_SIDED|95.0|-60.0|84.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Post-Bronchodilator FVC for Placebo versus Losmapimod 7.5 mg at Week 4||84|-60|0.741
72419608|NCT01218126|144350201|SUPERIORITY_OR_OTHER||Mean Difference (Net)|71.0||||0.056|TWO_SIDED|95.0|-1.8|143.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Post-Bronchodilator FVC for Placebo versus Losmapimod 15 mg at Week 4||143|-1.8|0.056
72419609|NCT01218126|144350201|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-25.0||||0.554|TWO_SIDED|95.0|-107.0|57.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Post-Bronchodilator FVC for Placebo versus Losmapimod 2.5 mg at Week 8||57|-107|0.554
72419610|NCT01218126|144350201|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-30.0||||0.472|TWO_SIDED|95.0|-110.0|51.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Post-Bronchodilator FVC for Placebo versus Losmapimod 7.5 mg at Week 8||51|-110|0.472
72419611|NCT01218126|144350201|SUPERIORITY_OR_OTHER||Mean Difference (Net)|66.0||||0.116|TWO_SIDED|95.0|-16.0|149.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Post-Bronchodilator FVC for Placebo versus Losmapimod 15 mg at Week 8||149|-16|0.116
72419612|NCT01218126|144350201|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-11.0||||0.805|TWO_SIDED|95.0|-98.0|76.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Post-Bronchodilator FVC for Placebo versus Losmapimod 2.5 mg at Week 12||76|-98|0.805
72419613|NCT01218126|144350201|SUPERIORITY_OR_OTHER||Mean Difference (Net)|13.0||||0.763|TWO_SIDED|95.0|-73.0|100.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Post-Bronchodilator FVC for Placebo versus Losmapimod 7.5 mg at Week 12||100|-73|0.763
72419614|NCT01218126|144350201|SUPERIORITY_OR_OTHER||Mean Difference (Net)|75.0||||0.096|TWO_SIDED|95.0|-13.0|163.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Post-Bronchodilator FVC for Placebo versus Losmapimod 15 mg at Week 12||163|-13|0.096
72419615|NCT01218126|144350201|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-31.0||||0.485|TWO_SIDED|95.0|-118.0|56.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Post-Bronchodilator FVC for Placebo versus Losmapimod 2.5 mg at Week 16||56|-118|0.485
72419616|NCT01218126|144350201|SUPERIORITY_OR_OTHER||Mean Difference (Net)|17.0||||0.704|TWO_SIDED|95.0|-69.0|103.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Post-Bronchodilator FVC for Placebo versus Losmapimod 7.5 mg at Week 16||103|-69|0.704
72419617|NCT01218126|144350201|SUPERIORITY_OR_OTHER||Mean Difference (Net)|72.0||||0.108|TWO_SIDED|95.0|-16.0|159.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Post-Bronchodilator FVC for Placebo versus Losmapimod 15 mg at Week 16||159|-16|0.108
72419618|NCT01218126|144350201|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-64.0||||0.147||95.0|-151.0|23.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Post-Bronchodilator FVC for Placebo versus Losmapimod 2.5 mg at Week 20||23|-151|0.147
72419619|NCT01218126|144350201|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-12.0||||0.792|TWO_SIDED|95.0|-98.0|75.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Post-Bronchodilator FVC for Placebo versus Losmapimod 7.5 mg at Week 20||75|-98|0.792
72419620|NCT01218126|144350201|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|49.0||||0.275||95.0|-39.0|138.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Post-Bronchodilator FVC for Placebo versus Losmapimod 15 mg at Week 20||138|-39|0.275
72613331|NCT02832037|144755366|OTHER|Mixed Model Repeated Measures included fixed, categorical factors of treatment, analysis visit as repeated measures per subject, and treatment by analysis visit interaction, continuous fixed covariate of baseline value and baseline value by analysis visit interaction, subject as random effect, covariance structure= Unstructured.|Difference of adjusted means|0.28|STANDARD_ERROR_OF_MEAN|0.8205||0.733|TWO_SIDED|95.0|-1.332|1.892||P-value is considered nominal.|Mixed Models Analysis|Kenward-Roger was used to estimate denominator degrees of freedom.|Difference was calculated as BI 425809 - placebo.|Secondary analysis. No formal hypotheses were tested.||1.892|-1.332|0.7330
72327058|NCT00444925|144177745|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Van Elteren's Test|P-value based on Van Elteren's Test adjusted by baseline UUI quartile.||Treatment Difference Tolterodine ER vs placebo at Week 1. Winsorized means (5% of the tails were censored, ie, replaced with the value at the 5th and 95th percentile, respectively).||||<0.0001
72327059|NCT00444925|144177745|SUPERIORITY_OR_OTHER|||||||0.846||95.0|||||Van Elteren's Test|P-value based on Van Elteren's Test adjusted by baseline UUI quartile.||Treatment Difference Fesoterodine vs Tolterodine ER at Week 1. Winsorized means (5% of the tails were censored, ie, replaced with the value at the 5th and 95th percentile, respectively).||||0.8460
72327060|NCT00444925|144177745|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Van Elteren's Test|P-value based on Van Elteren's Test adjusted by baseline UUI quartile.||Treatment Difference Fesoterodine vs placebo at Week 4. Winsorized means (5% of the tails were censored, ie, replaced with the value at the 5th and 95th percentile, respectively).||||<0.0001
72327061|NCT00444925|144177745|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Van Elteren's Test|P-value based on Van Elteren's Test adjusted by baseline UUI quartile.||Treatment Difference Tolterodine ER vs placebo at Week 4. Winsorized means (5% of the tails were censored, ie, replaced with the value at the 5th and 95th percentile, respectively).||||<0.0001
72327062|NCT00444925|144177745|SUPERIORITY_OR_OTHER|||||||0.1937||95.0|||||Van Elteren's Test|P-value based on Van Elteren's Test adjusted by baseline UUI quartile.||Treatment Difference Fesoterodine vs Tolterodine ER at Week 4. Winsorized means (5% of the tails were censored, ie, replaced with the value at the 5th and 95th percentile, respectively).||||0.1937
72327063|NCT00444925|144177746|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with country and treatment as factors, and ranked baseline value as a covariate.||Treatment Difference Fesoterodine vs placebo at Week 1. Per closed testing procedure, statistical testing for percent change not performed for Fesoterodine vs Tolterodine ER Week 1: corresponding numerical change result not statistically significant.||||<0.0001
72327064|NCT00444925|144177746|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with country and treatment as factors, and ranked baseline value as a covariate.||Treatment Difference Tolterodine ER vs placebo at Week 1. Per closed testing procedure, statistical testing for percent change not performed for Fesoterodine vs Tolterodine ER Week 1: corresponding numerical change result not statistically significant.||||<0.0001
72327065|NCT00444925|144177746|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with country and treatment as factors, and ranked baseline value as a covariate.||Treatment Difference Fesoterodine vs placebo at Week 4. Per closed testing procedure, statistical testing for percent change not performed for Fesoterodine vs Tolterodine ER Week 4: corresponding numerical change result not statistically significant.||||<0.0001
72327066|NCT00444925|144177746|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with country and treatment as factors, and ranked baseline value as a covariate.||Treatment Difference Tolterodine ER vs placebo at Week 4. Per closed testing procedure, statistical testing for percent change not performed for Fesoterodine vs Tolterodine ER Week 4: corresponding numerical change result not statistically significant.||||<0.0001
72327067|NCT00444925|144177746|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with country and treatment as factors, and ranked baseline value as a covariate.||Treatment Difference Fesoterodine vs placebo at Week 12.||||<0.0001
72327068|NCT00444925|144177746|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with country and treatment as factors, and ranked baseline value as a covariate.||Treatment Difference Tolterodine ER vs placebo at Week 12.||||<0.0001
72327069|NCT00444925|144177746|SUPERIORITY_OR_OTHER|||||||0.022||95.0||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with country and treatment as factors, and ranked baseline value as a covariate.||Treatment Difference Fesoterodine vs Tolterodine ER at Week 12.||||0.0220
72327070|NCT00444925|144177747|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.8|STANDARD_ERROR_OF_MEAN|3.4||0.0214|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference Least Squares Mean (LSMean) Difference Standard Error (SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs placebo at Week 1.||||0.0214
72419621|NCT01218126|144350201|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-28.0||||0.53|TWO_SIDED|95.0|-115.0|59.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Post-Bronchodilator FVC for Placebo versus Losmapimod 2.5 mg at Week 24||59|-115|0.530
72613332|NCT02832037|144755366|OTHER|Mixed Model Repeated Measures included fixed, categorical factors of treatment, analysis visit as repeated measures per subject, and treatment by analysis visit interaction, continuous fixed covariate of baseline value and baseline value by analysis visit interaction, subject as random effect, covariance structure= Unstructured.|Difference of adjusted means|0.137|STANDARD_ERROR_OF_MEAN|0.8074||0.8655|TWO_SIDED|95.0|-1.45|1.724||P-value is considered nominal.|Mixed Models Analysis|Kenward-Roger was used to estimate denominator degrees of freedom.|Difference was calculated as BI 425809 - placebo.|Secondary analysis. No formal hypotheses were tested.||1.724|-1.450|0.8655
72419622|NCT01218126|144350201|SUPERIORITY_OR_OTHER||Mean Difference (Net)|10.0||||0.827|TWO_SIDED|95.0|-77.0|96.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Post-Bronchodilator FVC for Placebo versus Losmapimod 7.5 mg at Week 24||96|-77|0.827
72613333|NCT02832037|144755366|OTHER|Mixed Model Repeated Measures included fixed, categorical factors of treatment, analysis visit as repeated measures per subject, and treatment by analysis visit interaction, continuous fixed covariate of baseline value and baseline value by analysis visit interaction, subject as random effect, covariance structure= Unstructured.|Difference of adjusted means|1.982|STANDARD_ERROR_OF_MEAN|0.7875||0.0122|TWO_SIDED|95.0|0.434|3.53||P-value is considered nominal.|Mixed Models Analysis|Kenward-Roger was used to estimate denominator degrees of freedom.|Difference was calculated as BI 425809 - placebo.|Secondary analysis. No formal hypotheses were tested.||3.530|0.434|0.0122
72613334|NCT02832037|144755366|OTHER|Mixed Model Repeated Measures included fixed, categorical factors of treatment, analysis visit as repeated measures per subject, and treatment by analysis visit interaction, continuous fixed covariate of baseline value and baseline value by analysis visit interaction, subject as random effect, covariance structure= Unstructured.|Difference of adjusted means|1.73|STANDARD_ERROR_OF_MEAN|0.7884||0.0287|TWO_SIDED|95.0|0.181|3.28||P-value is considered nominal.|Mixed Models Analysis|Kenward-Roger was used to estimate denominator degrees of freedom.|Difference was calculated as BI 425809 - placebo.|Secondary analysis. No formal hypotheses were tested.||3.280|0.181|0.0287
72613335|NCT02832037|144755367|OTHER|Analysis of covariance (ANCOVA) model estimates were used as input for the MCP-Mod. ANCOVA included treatment as fixed categorical factor, and baseline score as continuous fixed covariate.||||||0.066||||||P-value is considered nominal.|MCP-Mod linear model fit|||A flat vs. non-flat dose-response relationship across the 4 doses of BI 425809 and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 6 different plausible dose-response patterns (linear, linear in log, Emax, Sigmoid Emax, logistic, and beta) while protecting the overall probability of type I error (one-sided alpha of 0.05).||||0.0660
72613336|NCT02832037|144755367|OTHER|Analysis of covariance (ANCOVA) model estimates were used as input for the MCP-Mod. ANCOVA included treatment as fixed categorical factor, and baseline score as continuous fixed covariate.||||||0.1619||||||P-value is considered nominal.|MCP-Mod linear in log model fit|||A flat vs. non-flat dose-response relationship across the 4 doses of BI 425809 and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 6 different plausible dose-response patterns (linear, linear in log, Emax, Sigmoid Emax, logistic, and beta) while protecting the overall probability of type I error (one-sided alpha of 0.05).||||0.1619
72613337|NCT02832037|144755367|OTHER|Analysis of covariance (ANCOVA) model estimates were used as input for the MCP-Mod. ANCOVA included treatment as fixed categorical factor, and baseline score as continuous fixed covariate.||||||0.0832||||||P-value is considered nominal.|MCP-Mod Emax model fit|Model assumption: 20% of the maximum effect is achieved at 2 mg of BI 425809.||A flat vs. non-flat dose-response relationship across the 4 doses of BI 425809 and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 6 different plausible dose-response patterns (linear, linear in log, Emax, Sigmoid Emax, logistic, and beta) while protecting the overall probability of type I error (one-sided alpha of 0.05).||||0.0832
72613338|NCT02832037|144755367|OTHER|Analysis of covariance (ANCOVA) model estimates were used as input for the MCP-Mod. ANCOVA included treatment as fixed categorical factor, and baseline score as continuous fixed covariate.||||||0.0625||||||P-value is considered nominal.|MCP-Mod Sigmoid Emax model fit|Model assumption: 25% of the maximum effect is achieved at 5 mg and 75% of the maximum effect is achieved at 10 mg of BI 425809.||A flat vs. non-flat dose-response relationship across the 4 doses of BI 425809 and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 6 different plausible dose-response patterns (linear, linear in log, Emax, Sigmoid Emax, logistic, and beta) while protecting the overall probability of type I error (one-sided alpha of 0.05).||||0.0625
72613339|NCT02832037|144755367|OTHER|Analysis of covariance (ANCOVA) model estimates were used as input for the MCP-Mod. ANCOVA included treatment as fixed categorical factor, and baseline score as continuous fixed covariate.||||||0.0768||||||P-value is considered nominal.|MCP-Mod logistic model fit|Model assumption: 10% of the maximum effect is achieved at 5 mg and 50% of the maximum effect is achieved at 10 mg of BI 425809.||A flat vs. non-flat dose-response relationship across the 4 doses of BI 425809 and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 6 different plausible dose-response patterns (linear, linear in log, Emax, Sigmoid Emax, logistic, and beta) while protecting the overall probability of type I error (one-sided alpha of 0.05).||||0.0768
72613340|NCT02832037|144755367|OTHER|Analysis of covariance (ANCOVA) model estimates were used as input for the MCP-Mod. ANCOVA included treatment as fixed categorical factor, and baseline score as continuous fixed covariate.||||||0.7479||||||P-value is considered nominal.|MCP-Mod beta model fit|Assumption:75% of maximum (max) effect at 2mg, 87.5% of max effect at 5mg,25% of max effect at 25mg,max effect at 10mg BI 425809, scalar parameter=26.||A flat vs. non-flat dose-response relationship across the 4 doses of BI 425809 and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 6 different plausible dose-response patterns (linear, linear in log, Emax, Sigmoid Emax, logistic, and beta) while protecting the overall probability of type I error (one-sided alpha of 0.05).||||0.7479
72613341|NCT02832037|144755367|OTHER||Difference of adjusted means|1.178|STANDARD_ERROR_OF_MEAN|0.7306||0.11|TWO_SIDED|95.0|-0.258|2.613||P-value is considered nominal.|ANCOVA|Analysis of covariance (ANCOVA) model included treatment as fixed categorical factor, and baseline score as continuous fixed covariate.|Difference was calculated as BI 425809 - placebo.|Secondary analysis. No formal hypotheses were tested.||2.613|-0.258|0.11
72613342|NCT02832037|144755367|OTHER||Difference of adjusted means|-0.837|STANDARD_ERROR_OF_MEAN|0.7224||0.25|TWO_SIDED|95.0|-2.257|0.582||P-value is considered nominal.|ANCOVA|Analysis of covariance (ANCOVA) model included treatment as fixed categorical factor, and baseline score as continuous fixed covariate.|Difference was calculated as BI 425809 - placebo.|Secondary analysis. No formal hypotheses were tested.||0.582|-2.257|0.25
72613343|NCT02832037|144755367|OTHER||Difference of adjusted means|-0.263|STANDARD_ERROR_OF_MEAN|0.7152||0.71|TWO_SIDED|95.0|-1.669|1.142||P-value is considered nominal.|ANCOVA|Analysis of covariance (ANCOVA) model included treatment as fixed categorical factor, and baseline score as continuous fixed covariate.|Difference was calculated as BI 425809 - placebo.|Secondary analysis. No formal hypotheses were tested.||1.142|-1.669|0.71
72613344|NCT02832037|144755367|OTHER||Difference of adjusted means|-1.072|STANDARD_ERROR_OF_MEAN|0.7125||0.13|TWO_SIDED|95.0|-2.473|0.328||P-value is considered nominal.|ANCOVA|Analysis of covariance (ANCOVA) model included treatment as fixed categorical factor, and baseline score as continuous fixed covariate.|Difference was calculated as BI 425809 - placebo.|Secondary analysis. No formal hypotheses were tested.||0.328|-2.473|0.13
72613345|NCT02107898|144755373|SUPERIORITY_OR_OTHER||LS Mean Difference|-64.1|||<|0.0001|TWO_SIDED|95.0|-68.5|-59.8||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. Placebo|Alirocumab group was compared to placebo group using an appropriate contrast statement.||-59.8|-68.5|<0.0001
72613346|NCT02107898|144755374|SUPERIORITY_OR_OTHER||LS Mean Difference|-65.3|||<|0.0001|TWO_SIDED|95.0|-69.4|-61.3||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. Placebo|A hierarchical testing procedure was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when previous endpoint was statistically significant at 0.05 level.||-61.3|-69.4|<0.0001
72613347|NCT02107898|144755375|SUPERIORITY_OR_OTHER||LS Mean Difference|-61.5|||<|0.0001|TWO_SIDED|95.0|-65.3|-57.7||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-57.7|-65.3|<0.0001
72613348|NCT02107898|144755376|SUPERIORITY_OR_OTHER||LS Mean Difference|-62.1|||<|0.0001|TWO_SIDED|95.0|-65.8|-58.3||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-58.3|-65.8|<0.0001
72613349|NCT02107898|144755377|SUPERIORITY_OR_OTHER||LS Mean Difference|-53.3|||<|0.0001|TWO_SIDED|95.0|-57.5|-49.1||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-49.1|-57.5|<0.0001
72613350|NCT02107898|144755378|SUPERIORITY_OR_OTHER||LS Mean Difference|-53.8|||<|0.0001|TWO_SIDED|95.0|-57.8|-49.8||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-49.8|-57.8|<0.0001
72613351|NCT02107898|144755379|SUPERIORITY_OR_OTHER||LS Mean Difference|-57.5|||<|0.0001|TWO_SIDED|95.0|-61.5|-53.5||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-53.5|-61.5|<0.0001
72613352|NCT02107898|144755380|SUPERIORITY_OR_OTHER||LS Mean Difference|-58.6|||<|0.0001|TWO_SIDED|95.0|-62.3|-54.8||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-54.8|-62.3|<0.0001
72613353|NCT02107898|144755381|SUPERIORITY_OR_OTHER||LS Mean Difference|-41.5|||<|0.0001|TWO_SIDED|95.0|-44.6|-38.4||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-38.4|-44.6|<0.0001
72613354|NCT02107898|144755382|SUPERIORITY_OR_OTHER||LS Mean Difference|-51.2|||<|0.0001|TWO_SIDED|95.0|-54.9|-47.6||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-47.6|-54.9|<0.0001
72613355|NCT02107898|144755383|SUPERIORITY_OR_OTHER||LS Mean Difference|-54.5|||<|0.0001|TWO_SIDED|95.0|-57.9|-51.1|||Mixed Models Analysis||Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-51.1|-57.9|<0.0001
72613356|NCT02107898|144755384|SUPERIORITY_OR_OTHER||LS Mean Difference|-39.0|||<|0.0001|TWO_SIDED|95.0|-41.7|-36.4||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-36.4|-41.7|<0.0001
72613357|NCT02107898|144755385|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|552.1|||<|0.0001|TWO_SIDED|95.0|105.6|2886.8||Threshold for significance ≤ 0.05.|Regression, Logistic|Multiple imputation approach followed by logistic regression model.|Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||2886.8|105.6|<0.0001
72613358|NCT02107898|144755386|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1367.8|||<|0.0001|TWO_SIDED|95.0|137.8|13578.3||Threshold for significance ≤ 0.05.|Regression, Logistic|Multiple imputation approach followed by logistic regression model.|Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||13578.3|137.8|<0.0001
72327071|NCT00444925|144177747|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.2|STANDARD_ERROR_OF_MEAN|3.4||0.0149|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Tolterodine ER vs placebo at Week 1.||||0.0149
72327072|NCT00444925|144177747|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|2.7||0.8659|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs Tolterodine ER at Week 1.||||0.8659
72327073|NCT00444925|144177747|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.5|STANDARD_ERROR_OF_MEAN|4.0|<|0.0001|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs placebo at Week 4.||||<0.0001
72327074|NCT00444925|144177747|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.7|STANDARD_ERROR_OF_MEAN|4.0||0.0036|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Tolterodine ER vs placebo at Week 4.||||0.0036
72327075|NCT00444925|144177747|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.7|STANDARD_ERROR_OF_MEAN|3.3||0.1484|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs Tolterodine ER at Week 4.||||0.1484
72327076|NCT00444925|144177747|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.1|STANDARD_ERROR_OF_MEAN|4.1|<|0.0001|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs placebo at Week 12.||||<0.0001
72327077|NCT00444925|144177747|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.7|STANDARD_ERROR_OF_MEAN|4.1||0.1029|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Tolterodine ER vs placebo at Week 12.||||0.1029
72327078|NCT00444925|144177747|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.4|STANDARD_ERROR_OF_MEAN|3.3||0.0048|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs Tolterodine ER at Week 12.||||0.0048
72327079|NCT00444925|144177748|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.2||0.0002|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs placebo at Week 1.||||0.0002
72327080|NCT00444925|144177748|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|0.2||0.0006|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Tolterodine ER vs placebo at Week 1.||||0.0006
72327081|NCT00444925|144177748|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.1||0.7395|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs Tolterodine ER at Week 1.||||0.7395
72327082|NCT00444925|144177748|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs placebo at Week 4.||||<0.0001
72327083|NCT00444925|144177748|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.2||0.0007|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Tolterodine ER vs placebo at Week 4.||||0.0007
72327084|NCT00444925|144177748|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.1||0.4185|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs Tolterodine ER at Week 4.||||0.4185
72419623|NCT01218126|144350201|SUPERIORITY_OR_OTHER||Mean Difference (Net)|35.0||||0.434|TWO_SIDED|95.0|-53.0|124.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Post-Bronchodilator FVC for Placebo versus Losmapimod 15 mg at Week 24||124|-53|0.434
72327085|NCT00444925|144177748|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs placebo at Week 12.||||<0.0001
72419624|NCT01218126|144350202|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.6||||0.686|TWO_SIDED|95.0|-3.3|2.2|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Placebo versus Losmapimod 2.5 mg at Week 12||2.2|-3.3|0.686
72419625|NCT01218126|144350202|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.5||||0.279|TWO_SIDED|95.0|-1.2|4.2|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Placebo versus Losmapimod 7.5 mg at Week 12||4.2|-1.2|0.279
72419626|NCT01218126|144350202|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.8||||0.193|TWO_SIDED|95.0|-4.6|0.9|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Placebo versus Losmapimod 15 mg at Week 12||0.9|-4.6|0.193
72613359|NCT02107898|144755387|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-42.0|||<|0.0001|TWO_SIDED|95.0|-48.0|-36.0||Threshold for significance ≤ 0.05.|Regression, Robust|Multiple imputation approach followed by a robust regression model.|Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-36.0|-48.0|<0.0001
72613360|NCT02107898|144755388|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-22.0|||<|0.0001|TWO_SIDED|95.0|-30.9|-13.1||Threshold for significance ≤ 0.05.|Regression, Robust|Multiple imputation approach followed by a robust regression model.|Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-13.1|-30.9|<0.0001
72613361|NCT02107898|144755389|SUPERIORITY_OR_OTHER||LS Mean Difference|5.8||||0.002|TWO_SIDED|95.0|2.1|9.4||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||9.4|2.1|0.0020
72613362|NCT02107898|144755390|SUPERIORITY_OR_OTHER||LS Mean Difference|4.0||||0.0382|TWO_SIDED|95.0|0.2|7.9||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||7.9|0.2|0.0382
72613363|NCT02107898|144755391|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-41.4|||<|0.0001|TWO_SIDED|95.0|-47.0|-35.7||Threshold for significance ≤ 0.05.|Regression, Robust|Multiple imputation approach followed by a robust regression model.|Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-35.7|-47.0|<0.0001
72327086|NCT00444925|144177748|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.2||0.0005|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Tolterodine ER vs placebo at Week 12.||||0.0005
72613364|NCT02107898|144755392|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-15.5||||0.0007|TWO_SIDED|95.0|-24.4|-6.6||Threshold for significance ≤ 0.05.|Regression, Robust|Multiple imputation approach followed by a robust regression model.|Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-6.6|-24.4|0.0007
72613365|NCT02107898|144755393|SUPERIORITY_OR_OTHER||LS Mean Difference|6.5|||<|0.0001|TWO_SIDED|95.0|3.7|9.3||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||9.3|3.7|<0.0001
72613366|NCT02107898|144755394|SUPERIORITY_OR_OTHER||LS Mean Difference|6.3|||<|0.0001|TWO_SIDED|95.0|3.6|9.0||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||9.0|3.6|<0.0001
72613367|NCT01401166|144755406|SUPERIORITY_OR_OTHER||Estimated Proportion|0.957|||||TWO_SIDED|95.0|0.903|0.986|||||The estimated proportion of participants who preferred SC Herceptin and the corresponding exact binomial confidence interval (CI) were determined.|||0.986|0.903|
72613368|NCT01401166|144755406|SUPERIORITY_OR_OTHER||Estimated Proportion|0.964|||||TWO_SIDED|95.0|0.908|0.986|||||The estimated proportion of participants who preferred SC Herceptin and the corresponding CI were determined using logistic regression with factors of previous Herceptin status and treatment.|||0.986|0.908|
72613369|NCT01401166|144755406|SUPERIORITY_OR_OTHER||Estimated Proportion|0.874|||||TWO_SIDED|95.0|0.801|0.928|||||The estimated proportion of participants who preferred SC Herceptin and the corresponding exact binomial CI were determined.|||0.928|0.801|
72613370|NCT01401166|144755406|SUPERIORITY_OR_OTHER||Estimated Proportion|0.892|||||TWO_SIDED|95.0|0.804|0.943|||||The estimated proportion of participants who preferred SC Herceptin and the corresponding CI were determined using logistic regression with factors of previous Herceptin status and treatment.|||0.943|0.804|
72613371|NCT01401166|144755406|SUPERIORITY_OR_OTHER||Estimated Proportion|0.839|||||TWO_SIDED|95.0|0.76|0.9|||||The estimated proportion of participants who preferred SC Herceptin and the corresponding exact binomial CI were determined.|||0.900|0.760|
72613372|NCT01401166|144755406|SUPERIORITY_OR_OTHER||Estimated Proportion|0.874|||||TWO_SIDED|95.0|0.776|0.933|||||The estimated proportion of participants who preferred SC Herceptin and the corresponding CI were determined using logistic regression with factors of previous Herceptin status and treatment.|||0.933|0.776|
72613373|NCT01401166|144755406|SUPERIORITY_OR_OTHER||Estimated Proportion|0.885|||||TWO_SIDED|95.0|0.811|0.937|||||The estimated proportion of participants who preferred SC Herceptin and the corresponding exact binomial CI were determined.|||0.937|0.811|
72613374|NCT01401166|144755406|SUPERIORITY_OR_OTHER||Estimated Proportion|0.911|||||TWO_SIDED|95.0|0.827|0.956|||||The estimated proportion of participants who preferred SC Herceptin and the corresponding CI were determined using logistic regression with factors of previous Herceptin status and treatment.|||0.956|0.827|
72613375|NCT01932606|144755492|SUPERIORITY_OR_OTHER|||||||0.0003|TWO_SIDED||||||ANCOVA|||||||0.0003
72613376|NCT01932606|144755493|SUPERIORITY_OR_OTHER|||||||0.0003|TWO_SIDED||||||t-test, 2 sided|||Comparison between the arms for change in right atrial pressure.||||0.0003
72613377|NCT01932606|144755493|SUPERIORITY_OR_OTHER|||||||0.01|TWO_SIDED||||||t-test, 2 sided|||Comparison between the arms for change in pulmonary artery systolic pressure.||||0.01
72613378|NCT01932606|144755493|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED||||||t-test, 2 sided|||Comparison between the arms for change in mean pulmonary artery pressure.||||0.002
72613379|NCT01932606|144755493|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||t-test, 2 sided|||Comparison between the 2 arms for change in PCWP.||||<0.0001
72613380|NCT01932606|144755494|SUPERIORITY_OR_OTHER|||||||0.15|TWO_SIDED||||||t-test, 2 sided|||||||0.15
72613381|NCT01932606|144755495|SUPERIORITY_OR_OTHER|||||||0.11|TWO_SIDED||||||t-test, 2 sided|||Comparison between the arms for change in systolic blood pressure.||||0.11
72613382|NCT01932606|144755495|SUPERIORITY_OR_OTHER|||||||0.2|TWO_SIDED||||||t-test, 2 sided|||Comparison between the arms for change in mean blood pressure.||||0.2
72613383|NCT01932606|144755496|SUPERIORITY_OR_OTHER|||||||0.7|TWO_SIDED||||||t-test, 2 sided|||Comparison between the arms for change in PVR.||||0.7
72613384|NCT01932606|144755497|SUPERIORITY_OR_OTHER|||||||0.1|TWO_SIDED||||||t-test, 2 sided|||Comparison between the arms for change in pulmonary artery compliance.||||0.1
72613385|NCT01932606|144755498|SUPERIORITY_OR_OTHER|||||||0.3|TWO_SIDED||||||t-test, 2 sided|||Comparison between the arms for change in SVR.||||0.3
72613386|NCT01932606|144755499|SUPERIORITY_OR_OTHER|||||||0.3|TWO_SIDED||||||t-test, 2 sided|||Comparison between the arms for change in LVSW.||||0.3
72613387|NCT01932606|144755500|SUPERIORITY_OR_OTHER|||||||0.8|TWO_SIDED||||||t-test, 2 sided|||Comparison between the arms for change in VO\_2.||||0.8
72613388|NCT01932606|144755501|SUPERIORITY_OR_OTHER|||||||0.1|TWO_SIDED||||||t-test, 2 sided|||Comparison between the arms for arteriovenous oxygen content difference.||||0.1
72613389|NCT01932606|144755502|SUPERIORITY_OR_OTHER|||||||0.4|TWO_SIDED||||||t-test, 2 sided|||Comparison between the arms for change in cardiac output.||||0.4
72613390|NCT01932606|144755503|SUPERIORITY_OR_OTHER|||||||0.4|TWO_SIDED||||||t-test, 2 sided|||Comparison between the arms for change in stroke volume.||||0.4
72613391|NCT01932606|144755504|SUPERIORITY_OR_OTHER|||||||0.0002|TWO_SIDED||||||t-test, 2 sided|||Comparison between the arms for change in right atrial pressure (exercise).||||0.0002
72613392|NCT01932606|144755504|SUPERIORITY_OR_OTHER|||||||0.01|TWO_SIDED||||||t-test, 2 sided|||Comparison between the arms for change in pulmonary artery systolic pressure (exercise).||||0.01
72613393|NCT01932606|144755504|SUPERIORITY_OR_OTHER|||||||0.0002|TWO_SIDED||||||t-test, 2 sided|||Comparison between the arms for change in mean pulmonary artery pressure (exercise).||||0.0002
72613394|NCT01932606|144755504|SUPERIORITY_OR_OTHER|||||||0.0002|TWO_SIDED||||||t-test, 2 sided|||Comparison between the arms for change in PCWP (exercise).||||0.0002
72613395|NCT01932606|144755505|SUPERIORITY_OR_OTHER|||||||0.3|TWO_SIDED||||||t-test, 2 sided|||Comparison between the arms for change in heart rate.||||0.3
72327087|NCT00444925|144177748|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.1||0.3798|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs Tolterodine ER at Week 12.||||0.3798
72327088|NCT00444925|144177749|SUPERIORITY_OR_OTHER|||||||0.0001||95.0||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with country and treatment as factors, and ranked baseline value as a covariate.||Treatment Difference Fesoterodine vs placebo at Week 1. Per closed testing procedure, statistical testing for percent change not performed for Fesoterodine vs Tolterodine ER Week 1: corresponding numerical change result not statistically significant.||||0.0001
72327089|NCT00444925|144177749|SUPERIORITY_OR_OTHER|||||||0.0002||95.0||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with country and treatment as factors, and ranked baseline value as a covariate.||Treatment Difference Tolterodine ER vs placebo at Week 1. Per closed testing procedure, statistical testing for percent change not performed for Fesoterodine vs Tolterodine ER Week 1: corresponding numerical change result not statistically significant.||||0.0002
72327090|NCT00444925|144177749|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with country and treatment as factors, and ranked baseline value as a covariate.||Treatment Difference Fesoterodine vs placebo at Week 4. Per closed testing procedure, statistical testing for percent change not performed for Fesoterodine vs Tolterodine ER Week 4: corresponding numerical change result not statistically significant.||||<0.0001
72327091|NCT00444925|144177749|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with country and treatment as factors, and ranked baseline value as a covariate.||Treatment Difference Tolterodine ER vs placebo at Week 4. Per closed testing procedure, statistical testing for percent change not performed for Fesoterodine vs Tolterodine ER Week 4: corresponding numerical change result not statistically significant.||||<0.0001
72327092|NCT00444925|144177749|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with country and treatment as factors, and ranked baseline value as a covariate.||Treatment Difference Fesoterodine vs placebo at Week 12. Per closed testing procedure, statistical testing for percent change not performed for Fesoterodine vs Tolterodine ER Week 12: corresponding numerical change result not statistically significant.||||<0.0001
72327093|NCT00444925|144177749|SUPERIORITY_OR_OTHER|||||||0.0003||95.0||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with country and treatment as factors, and ranked baseline value as a covariate.||Treatment Difference Tolterodine ER vs placebo at Week 12. Per closed testing procedure, statistical testing for percent change not performed for Fesoterodine vs Tolterodine ER Week 12: corresponding numerical change result not statistically significant.||||0.0003
72327094|NCT00444925|144177750|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.1||0.273|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs placebo at Week 1.||||0.2730
72419627|NCT01218126|144350202|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.4||||0.803|TWO_SIDED|95.0|-2.7|3.5|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Placebo versus Losmapimod 2.5 mg at Week 24||3.5|-2.7|0.803
72327095|NCT00444925|144177750|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.1||0.0652|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Tolterodine ER vs placebo at Week 1.||||0.0652
72327096|NCT00444925|144177750|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.1||0.3503|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs Tolterodine ER at Week 1.||||0.3503
72327097|NCT00444925|144177750|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.1||0.2667|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs placebo at Week 4.||||0.2667
72419628|NCT01218126|144350202|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.9||||0.229|TWO_SIDED|95.0|-1.2|5.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Placebo versus Losmapimod 7.5 mg at Week 24||5.0|-1.2|0.229
72613396|NCT01932606|144755506|SUPERIORITY_OR_OTHER|||||||0.2|TWO_SIDED||||||t-test, 2 sided|||Comparison between the arms for change in systolic blood pressure.||||0.2
72327098|NCT00444925|144177750|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.1||0.1643|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Tolterodine ER vs placebo at Week 4.||||0.1643
72613397|NCT01932606|144755506|SUPERIORITY_OR_OTHER|||||||0.05|TWO_SIDED||||||t-test, 2 sided|||Comparison between the arms for change in diastolic blood pressure.||||0.05
72613398|NCT01932606|144755507|SUPERIORITY_OR_OTHER|||||||0.3|TWO_SIDED||||||t-test, 2 sided|||Comparison between the arms for change in PVR after study drug (exercise)||||0.3
72613399|NCT01932606|144755508|SUPERIORITY_OR_OTHER|||||||0.3|TWO_SIDED||||||t-test, 2 sided|||Comparison between the arms for change in PA compliance after study drug (exercise)||||0.3
72613400|NCT01932606|144755509|SUPERIORITY_OR_OTHER|||||||0.007|TWO_SIDED||||||t-test, 2 sided|||Comparison between the arms for change in SVR after study drug (exercise).||||0.007
72613401|NCT01932606|144755510|SUPERIORITY_OR_OTHER|||||||0.0003|TWO_SIDED||||||t-test, 2 sided|||Comparison between the arms for change in LVSW after study drug (exercise)||||0.0003
72613402|NCT01932606|144755511|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED||||||t-test, 2 sided|||Comparison between the arms for change in oxygen consumption (VO\_2) after study drug (exercise).||||0.02
72613403|NCT01932606|144755512|SUPERIORITY_OR_OTHER|||||||0.6|TWO_SIDED||||||t-test, 2 sided|||Comparison between the arms for change in arteriovenous oxygen difference after study drug (exercise).||||0.6
72613404|NCT01932606|144755513|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED||||||t-test, 2 sided|||Comparison between the arms for change in cardiac output after study drug (exercise).||||0.002
72613405|NCT01932606|144755514|SUPERIORITY_OR_OTHER|||||||0.0002|TWO_SIDED||||||t-test, 2 sided|||Comparison between the arms for change in stroke volume after study drug (exercise).||||0.0002
72613406|NCT03881371|144755515|SUPERIORITY||Least-Square Mean|-1.1|STANDARD_ERROR_OF_MEAN|0.277|<|0.0001|TWO_SIDED|95.0|-1.643|-0.555||"Analysis was based on a covariance model (ANCOVA) with treatment and centre as independent factors, baseline mean total daily OFF time measurement as covariate and change from baseline as dependent variable."|ANCOVA|||Treatment difference (Safinamide - Placebo)||-0.555|-1.643|<.0001
72613407|NCT03881371|144755516|SUPERIORITY||Least-Square Mean|-0.03|STANDARD_ERROR_OF_MEAN|0.21||0.8901|TWO_SIDED|95.0|-0.44|0.382||ANCOVA with treatment and centre as independent factors, baseline NRS measurement as covariate and change from baseline as dependent variable.|ANCOVA|||Treatment difference (Safinamide - Placebo)||0.382|-0.440|0.8901
72613408|NCT03881371|144755517|SUPERIORITY||Least-Square Mean|0.89|STANDARD_ERROR_OF_MEAN|0.315||0.0049|TWO_SIDED|95.0|0.274|1.515||"ANCOVA with treatment and centre as independent factors, baseline mean total daily ON time measurement as covariate and change from baseline as dependent variable."|ANCOVA|||Treatment difference (Safinamide - Placebo)||1.515|0.274|0.0049
72613409|NCT03881371|144755518|SUPERIORITY||Least-Square Mean|1.07|STANDARD_ERROR_OF_MEAN|0.345||0.0021|TWO_SIDED|95.0|0.392|1.753||"ANCOVA with treatment and centre as independent factors, baseline mean total daily ON time with no/non-troublesome Dyskinesia measurement as covariate and change from baseline as dependent variable."|ANCOVA|||||1.753|0.392|0.0021
72613410|NCT03881371|144755519|SUPERIORITY||Least-Square Mean|-5.99|STANDARD_ERROR_OF_MEAN|1.447|<|0.0001|TWO_SIDED|95.0|-8.842|-3.141||ANCOVA with treatment and centre as independent factors, baseline UPDRS score as covariate and change from baseline as dependent variable.|ANCOVA|||Treatment difference (Safinamide - Placebo)||-3.141|-8.842|<.0001
72613411|NCT03881371|144755520|SUPERIORITY||Least-Square Mean|-1.52|STANDARD_ERROR_OF_MEAN|0.51||0.0033|TWO_SIDED|95.0|-2.521|-0.511||ANCOVA with treatment and centre as independent factors, baseline UPDRS part II (ADL) score as covariate and change from baseline as dependent variable.|ANCOVA|||Treatment difference (Safinamide - Placebo)||-0.511|-2.521|0.0033
72613412|NCT03881371|144755521|SUPERIORITY||Least-Square Mean|-3.8|STANDARD_ERROR_OF_MEAN|0.988||0.0002|TWO_SIDED|95.0|-5.749|-1.856||ANCOVA with treatment and centre as independent factors, baseline UPDRS part III (motor function) score as covariate and change from baseline as dependent variable.|ANCOVA|||Treatment difference (Safinamide - Placebo)||-1.856|-5.749|0.0002
72613413|NCT03881371|144755522|SUPERIORITY||Median|0.0||||0.015|TWO_SIDED|95.0|0.0|0.0||Analysis was based on the Wilcoxon-Mann-Whitney test stratified by centre.|Wilcoxon (Mann-Whitney)||Non-parametric 95% confidence interval was presented for the treatment difference in CGI-S at each post-baseline visit as reported by the Hodges-Lehmann estimator.|Treatment difference (Safinamide - Placebo)||0.000|0.000|0.0150
72613414|NCT03881371|144755523|SUPERIORITY||Median|0.5||||0.0007|TWO_SIDED|95.0|0.0|1.0||Analysis was based on the Wilcoxon-Mann-Whitney test stratified by centre.|Wilcoxon (Mann-Whitney)||Non-parametric 95% confidence interval was presented for the treatment difference in CGI-C score at each post-baseline visit as reported by the Hodges-Lehmann estimator.|Treatment difference (Safinamide - Placebo)||1.000|0.000|0.0007
72613415|NCT03881371|144755524|SUPERIORITY||Least-Square Mean|-3.36|STANDARD_ERROR_OF_MEAN|1.132||0.0033|TWO_SIDED|95.0|-5.589|-1.128||ANCOVA with treatment and centre as independent factor, baseline Summary Index score as covariate and change from baseline as dependent variable.|ANCOVA|||Treatment difference (Safinamide - Placebo)||-1.128|-5.589|0.0033
72613416|NCT00933933|144755533|SUPERIORITY_OR_OTHER||Clinical Specificity|99.77|||||TWO_SIDED|95.0|99.62|99.88|||Exact binomial|||||99.88|99.62|
72613417|NCT00933933|144755534|SUPERIORITY_OR_OTHER||Clinical Sensitivity|100.0|||||TWO_SIDED|95.0|94.31|100.0|||Exact binomial|||||100.00|94.31|
72613418|NCT00933933|144755534|SUPERIORITY_OR_OTHER||Clinical Sensitivity|100.0|||||TWO_SIDED|95.0|99.63|100.0|||Exact binomial|||||100.00|99.63|
72613419|NCT00933933|144755534|SUPERIORITY_OR_OTHER||Clinical Sensitivity|100.0|||||TWO_SIDED|95.0|98.18|100.0|||Exact binomial|||||100.00|98.18|
72613420|NCT00933933|144755535|SUPERIORITY_OR_OTHER||Clinical Specificity|100.0|||||TWO_SIDED|95.0|99.18|100.0|||Exact binomial|||||100.00|99.18|
72613421|NCT00933933|144755535|SUPERIORITY_OR_OTHER||Clinical Sensitivity|100.0|||||TWO_SIDED|95.0|94.48|100.0|||Exact binomial|||||100.00|94.48|
72613422|NCT00933933|144755536|SUPERIORITY_OR_OTHER||Clinical Specificity|99.83|||||TWO_SIDED|95.0|99.06|100.0|||Exact binomial|||||100.00|99.06|
72613423|NCT00933933|144755536|SUPERIORITY_OR_OTHER||Clinical Sensitivity|100.0|||||TWO_SIDED|95.0|94.4|100.0|||Exact binomial|||||100.00|94.40|
72613424|NCT01532089|144755541|SUPERIORITY||Hazard Ratio (HR)|0.81||||0.39|TWO_SIDED|95.0|0.5|1.31|||Log Rank|Comparisons of PFS between arms were conducted using a stratified log-rank test.||||1.31|0.50|0.39
72613425|NCT01532089|144755542|SUPERIORITY||Hazard Ratio (HR)|1.41||||0.33|TWO_SIDED|95.0|0.71|2.81|||Log Rank|||||2.81|0.71|0.33
72613426|NCT01532089|144755543|SUPERIORITY|||||||0.81|||||||Chi-squared|||||||0.81
72613427|NCT01995201|144755551|OTHER|||||||0.5231|||||||Chi-squared|||||||0.5231
72613428|NCT03329001|144755594|OTHER||Ratio of geometric least square mean|0.911|||||TWO_SIDED|90.0|0.855|0.9706|||||Relative bioavailability (AUC\[tablet\]/AUC\[capsule\]) was assessed using analysis of variance (ANOVA) model accounting for sequence, participants nested with sequences, period and treatment.|||0.9706|0.8550|
72613429|NCT03329001|144755595|OTHER||Ratio of geometric least square mean|0.9216|||||TWO_SIDED|90.0|0.8631|0.9841|||||Relative bioavailability (AUC\[tablet\]/AUC\[capsule\]) was assessed using ANOVA model accounting for sequence, participants nested with sequences, period and treatment.|||0.9841|0.8631|
72613430|NCT03329001|144755596|OTHER||Ratio of geometric least square mean|0.9483|||||TWO_SIDED|90.0|0.8489|1.0593|||||Relative bioavailability (Cmax\[tablet\]/Cmax\[capsule\]) was assessed using ANOVA model accounting for sequence, participants nested with sequences, period and treatment.|||1.0593|0.8489|
72613431|NCT03329001|144755601|EQUIVALENCE|Bioequivalence was concluded if the 90% confidence interval of the ratio of geometric least-squares means of the test (tablet) to reference (capsule) product was within 0.80 - 1.25% for AUC0-t|Ratio of geometric least square mean|0.9594|||||TWO_SIDED|90.0|0.9199|1.0006|||||Analysis was performed using linear mixed model with fixed effects of treatment, period, sequence, and random effect for participant nested within sequence. Ratio of geometric least square mean of niraparib tablet to niraparib capsule is presented.|||1.0006|0.9199|
72613432|NCT03329001|144755602|EQUIVALENCE|Bioequivalence was concluded if the 90% confidence interval of the ratio of geometric least-squares means of the test (tablet) to reference (capsule) product was within 0.80 - 1.25% for AUC0-inf|Ratio of geometric least square mean|0.9566|||||TWO_SIDED|90.0|0.9164|0.9986|||||Analysis was performed using linear mixed model with fixed effects of treatment, period, sequence, and random effect for participant nested within sequence. Ratio of geometric least square mean of niraparib tablet to niraparib capsule is presented.|||0.9986|0.9164|
72613433|NCT03329001|144755603|EQUIVALENCE|Bioequivalence was concluded if the 90% confidence interval of the ratio of geometric least-squares means of the test (tablet) to reference (capsule) product was within 0.80 - 1.25% for Cmax|Ratio of geometric least square mean|0.9619|||||TWO_SIDED|90.0|0.9124|1.014|||||Analysis was performed using linear mixed model with fixed effects of treatment, period, sequence, and random effect for participant nested within sequence. Ratio of geometric least square mean of niraparib tablet to niraparib capsule is presented.|||1.0140|0.9124|
72613434|NCT03329001|144755608|OTHER||Ratio of geometric least square mean|1.3154|||||TWO_SIDED|90.0|1.1742|1.4735|||||Analysis was performed using linear mixed model with fixed effects of treatment, period, sequence, and random effect for participant nested within sequence.|||1.4735|1.1742|
72613435|NCT03329001|144755609|OTHER||Ratio of geometric least square mean|1.2771|||||TWO_SIDED|90.0|1.1537|1.4137|||||Analysis was performed using linear mixed model with fixed effects of treatment, period, sequence, and random effect for participant nested within sequence.|||1.4137|1.1537|
72613436|NCT03329001|144755610|OTHER||Ratio of geometric least square mean|1.1129|||||TWO_SIDED|90.0|0.9408|1.3164|||||Analysis was performed using linear mixed model with fixed effects of treatment, period, sequence, and random effect for participant nested within sequence.|||1.3164|0.9408|
72613437|NCT02178956|144755624|SUPERIORITY||Hazard Ratio (HR)|1.01||||0.8596|TWO_SIDED|95.0|0.86|1.02||two-sided|Log Rank|stratified log rank test stratified by region, time to progression on 1st line therapy and disease measurability.|HR is for napabucasin + Paclitaxel vs Placebo + Paclitaxel. Based on Cox Proportional hazards model stratified by actual stratification variables including region, time to progression on first line therapy and disease measurability.|||1.02|0.86|0.8596
72613438|NCT02178956|144755625|SUPERIORITY||Hazard Ratio (HR)|1.01||||0.9028|TWO_SIDED|95.0|0.85|1.19||two sided|Log Rank|stratified log rank test stratified by region, time to progression on 1st line therapy and disease measurability.|HR is for napabucuasin + Paclitaxel vs Placebo + Paclitaxel. Based on Cox Proportional hazards model stratified by actual stratification variables including region, time to progression on first line therapy and disease measurability.|||1.19|0.85|0.9028
72613439|NCT02178956|144755626|SUPERIORITY||Odds Ratio (OR)|0.93||||0.7359|TWO_SIDED|95.0|0.6|1.44||2-sided|Cochran-Mantel-Haenszel|Based on CMH test stratified by actual stratification variables at baseline including region, and time to progression on first-line therapy.|Odds ratio for napabucasin vs. Placebo. Based on Logistic Regression Model adjusting for actual Stratification variables at baseline including region, and time to progression on first-line therapy.|||1.44|0.60|0.7359
72613440|NCT02178956|144755627|SUPERIORITY||Odds Ratio (OR)|0.93||||0.6555|TWO_SIDED|95.0|0.66|1.3||2-sided|Cochran-Mantel-Haenszel|Based on CMH test stratified by actual stratification variables at baseline including region, and time to progression on first-line therapy.|Odds ratio for napabucasin vs. Placebo. Based on Logistic Regression Model adjusting for actual Stratification variables at baseline including region, and time to progression on first-line therapy.|||1.30|0.66|0.6555
72613441|NCT00622518|144755629|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED|95.0||||P value is based on rating\*group interaction term|linear mixed model|||||||.002
72613442|NCT03769493|144755632|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||< .001
72613443|NCT03769493|144755633|SUPERIORITY|||||||0.875|||||||t-test, 2 sided|||||||.875
72613444|NCT00311168|144755759|SUPERIORITY|A target of an 80% reduction in percentage of ventricular pacing with VIP™ is proposed in this study. In order to achieve an 80% power of detecting an 80% reduction in the percentage of ventricular paced events and using a two group two-sided t-test of equal means, a minimum sample size of 39 patients per group was required. To account for possible withdrawal or loss to follow-up, this study targeted to enroll 100 patients (50 per group).|Mean Difference (Final Values)|-60.2|STANDARD_DEVIATION|19.0|<|0.0001|TWO_SIDED|95.0|-67.5|-52.9|||t-test, 2 sided||Mean difference in the percentage of intrinsic ventricular events is presented as, VIP Off - VIP On.|||-52.9|-67.5|<0.0001
72613445|NCT05850494|144755780|NON_INFERIORITY|Non-inferiority margin of -0.200 L at a one-sided significance level of 0.025.|Mean Difference (Net)|-0.009|STANDARD_ERROR_OF_MEAN|0.0136|||TWO_SIDED|95.0|-0.037|0.018||P-Value not applicable since a non-inferiority test was used for the analysis.|Mixed Models Analysis|||||0.018|-0.037|
72613446|NCT00695019|144755837|SUPERIORITY_OR_OTHER_LEGACY|||||||0.61||95.0|||||Chi-squared|||||||0.61
72613447|NCT00695019|144755838|SUPERIORITY_OR_OTHER_LEGACY|||||||0.48||95.0|||||Chi-squared|||||||0.48
72613448|NCT00695019|144755839|SUPERIORITY_OR_OTHER_LEGACY|||||||0.77||95.0|||||Kruskal-Wallis|||||||0.77
72613449|NCT00695019|144755840|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3||95.0|||||Kruskal-Wallis|||||||0.30
72613450|NCT00695019|144755841|SUPERIORITY_OR_OTHER_LEGACY|||||||0.72||95.0|||||Chi-squared|||||||0.72
72613451|NCT00695019|144755842|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0023||95.0||||Analysis not adjusted to account for baseline differences between the groups.|Kruskal-Wallis|||||||0.0023
72613452|NCT00695019|144755843|SUPERIORITY_OR_OTHER_LEGACY|||||||0.21||95.0|||||Kruskal-Wallis|||Fibrotest provides an estimate of liver fibrosis based on the values of 5 serum markers. Scores range from 0 to 1 with higher scores indicating a greater level of liver fibrosis. A negative change in Fibrotest score is therefore deemed to indicate improvement (reduction in fibrosis), while a positive change indicates worsening condition.||||0.21
72613453|NCT00695019|144755844|SUPERIORITY_OR_OTHER_LEGACY|||||||0.03||95.0|||||Chi-squared|||||||0.03
72613454|NCT00695019|144755844|SUPERIORITY_OR_OTHER_LEGACY|||||||0.005||95.0|||||Chi-squared|||||||0.005
72613455|NCT05523297|144755881|NON_INFERIORITY|The test for non-inferiority was one-sided Farrington-Manning score test with non-inferiority margin 10% at a significance level of 2.5%. If the 95% CI for treatment effect not only lay above -10% (the non-inferiority margin) but also above 0, then there was evidence of superiority.|percent difference|17.55|||<|0.0001|TWO_SIDED|95.0|8.7|26.4|||Two-sided Farrington-Manning score test.||Difference between Octaplex and FP arms for effectiveness|||26.4|8.7|<0.0001
72613456|NCT05523297|144755882|OTHER||Odds Ratio (OR)|1.91||||0.0022|TWO_SIDED|95.0|1.26|2.88|||Regression, Logistic|||||2.88|1.26|0.0022
72613457|NCT05523297|144755883|OTHER||Least Squares Mean Difference|-170.73|||<|0.0001|TWO_SIDED|95.0|-250.24|-91.22|||ANOVA|||12 hours after chest closure||-91.22|-250.24|<0.0001
72613458|NCT05523297|144755883|OTHER||Least Squares Mean Difference|-231.92|||<|0.0001|TWO_SIDED|95.0|-338.17|-125.67|||ANOVA|||24 hours after chest closure||-125.67|-338.17|<0.0001
72613459|NCT05523297|144755884|OTHER||Odds Ratio (OR)|3.19|||<|0.0001|TWO_SIDED|95.0|1.97|5.15|||Regression, Logistic|||Within 24 hours after IMP start||5.15|1.97|<0.0001
72613460|NCT05523297|144755884|OTHER||Odds Ratio (OR)|2.88|||<|0.0001|TWO_SIDED|95.0|1.83|4.52|||Regression, Logistic|||Within 24 hours after surgery start||4.52|1.83|<0.0001
72613461|NCT05523297|144755884|OTHER||Odds Ratio (OR)|3.19|||<|0.0001|TWO_SIDED|95.0|1.97|5.15|||Regression, Logistic|||Within 24 hours after CPB end||5.15|1.97|<0.0001
72613462|NCT05523297|144755885|OTHER||Mean ratio|0.48|||<|0.0001|TWO_SIDED|95.0|0.41|0.57|||Counting regression|||||0.57|0.41|<0.0001
72613463|NCT05523297|144755886|OTHER||Mean ratio|0.71||||0.0015|TWO_SIDED|95.0|0.57|0.88|||Counting regression|||||0.88|0.57|0.0015
72613464|NCT05523297|144755887|OTHER||Mean ratio|0.61||||0.001|TWO_SIDED|95.0|0.46|0.82|||Counting regression|||During the first 24 hours after IMP start||0.82|0.46|0.0010
72613465|NCT05523297|144755887|OTHER||Mean ratio|0.59|||<|0.0001|TWO_SIDED|95.0|0.45|0.76|||Counting regression|||During the first 7 days after IMP start||0.76|0.45|<0.0001
72613466|NCT05523297|144755888|OTHER||Mean ratio|0.04|||<|0.0001|TWO_SIDED|95.0|0.03|0.06|||Negative binomial regression|||FP including IMP (During the first 24 hours after IMP start)||0.06|0.03|<0.0001
72613467|NCT05523297|144755888|OTHER||Mean ratio|0.85||||0.8522|TWO_SIDED|95.0|0.15|4.82|||Negative binomial regression|||FP excluding IMP (During the first 24 hours after IMP start)||4.82|0.15|0.8522
72613468|NCT05523297|144755888|OTHER||Mean ratio|0.52|||<|0.0001|TWO_SIDED|95.0|0.4|0.68|||Negative binomial regression|||RBCs (During the first 24 hours after IMP start)||0.68|0.40|<0.0001
72613469|NCT05523297|144755888|OTHER||Mean ratio|0.65||||0.0169|TWO_SIDED|95.0|0.45|0.92|||Negative binomial regression|||Platelets (During the first 24 hours after IMP start)||0.92|0.45|0.0169
72613470|NCT05523297|144755888|OTHER||Mean ratio|0.57||||0.3288|TWO_SIDED|95.0|0.18|1.76|||Negative binomial regression|||Cryoprecipitate (During the first 24 hours after IMP start)||1.76|0.18|0.3288
72613471|NCT05523297|144755888|OTHER||Mean ratio|0.05|||<|0.0001|TWO_SIDED|95.0|0.04|0.06|||Negative binomial regression|||FP including IMP (During the first 7 days after IMP start)||0.06|0.04|<0.0001
72613472|NCT05523297|144755888|OTHER||Mean ratio|0.63||||0.5439|TWO_SIDED|95.0|0.14|2.84|||Negative binomial regression|||FP excluding IMP (During the first 7 days after IMP start)||2.84|0.14|0.5439
72613473|NCT05523297|144755888|OTHER||Mean ratio|0.59|||<|0.0001|TWO_SIDED|95.0|0.47|0.74|||Negative binomial regression|||Red blood cells (During the first 7 days after IMP start)||0.74|0.47|<0.0001
72613474|NCT05523297|144755888|OTHER||Mean ratio|0.58||||0.0042|TWO_SIDED|95.0|0.4|0.84|||Negative binomial regression|||Platelets (During the first 7 days after IMP start)||0.84|0.40|0.0042
72613475|NCT05523297|144755888|OTHER||Mean ratio|0.49||||0.2241|TWO_SIDED|95.0|0.15|1.56|||Negative binomial regression|||Cryoprecipitate (During the first 7 days after IMP start)||1.56|0.15|0.2241
72613476|NCT05523297|144755889|OTHER||Odds Ratio (OR)|0.9||||0.8364|TWO_SIDED|95.0|0.32|2.52|||Regression, Logistic|||FP excluding IMP (Within 24 hours after IMP start)||2.52|0.32|0.8364
72613477|NCT05523297|144755889|OTHER||Odds Ratio (OR)|2.11||||0.0002|TWO_SIDED|95.0|1.42|3.11|||Regression, Logistic|||RBCs (Within 24 hours after IMP start)||3.11|1.42|0.0002
72419629|NCT01218126|144350202|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.4||||0.39|TWO_SIDED|95.0|-4.5|1.8|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Placebo versus Losmapimod 15 mg at Week 24||1.8|-4.5|0.390
72419630|NCT01218126|144350204|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.96||||0.157|TWO_SIDED|95.0|0.91|1.01|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Placebo versus Losmapimod 2.5 mg at Week 4||1.01|0.91|0.157
72419631|NCT01218126|144350204|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.91||||0|TWO_SIDED|95.0|0.86|0.95|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Placebo versus Losmapimod 7.5 mg at Week 4||0.95|0.86|0.000
72419632|NCT01218126|144350204|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.91||||0|TWO_SIDED|95.0|0.86|0.96|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Placebo versus Losmapimod 15 mg at Week 4||0.96|0.86|0.000
72327099|NCT00444925|144177750|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.1||0.7264|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs Tolterodine ER at Week 4.||||0.7264
72327100|NCT00444925|144177750|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.1||0.3269|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs placebo at Week 12.||||0.3269
72327101|NCT00444925|144177750|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.1||0.5059|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Tolterodine ER vs placebo at Week 12.||||0.5059
72327102|NCT00444925|144177750|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.1||0.699|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs Tolterodine ER at Week 12.||||0.6990
72327103|NCT00444925|144177752|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|0.2||0.0008|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs placebo at Week 1.||||0.0008
72327104|NCT00444925|144177752|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Tolterodine ER vs placebo at Week 1.||||<0.0001
72327105|NCT00444925|144177752|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|0.2||0.382|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs Tolterodine ER at Week 1.||||0.3820
72327106|NCT00444925|144177752|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.4|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs placebo at Week 4.||||<0.0001
72327107|NCT00444925|144177752|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.2|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Tolterodine ER vs placebo at Week 4.||||<0.0001
72327108|NCT00444925|144177752|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.2||0.3498|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs Tolterodine ER at Week 4.||||0.3498
72327109|NCT00444925|144177752|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.5|STANDARD_ERROR_OF_MEAN|0.3|<|0.0001|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs placebo at Week 12.||||<0.0001
72327110|NCT00444925|144177752|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.1|STANDARD_ERROR_OF_MEAN|0.3|<|0.0001|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Tolterodine ER vs placebo at Week 12.||||<0.0001
72327111|NCT00444925|144177752|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.2||0.0542|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs Tolterodine ER at Week 12.||||0.0542
72327112|NCT00444925|144177753|SUPERIORITY_OR_OTHER|||||||0.0004||95.0||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with country and treatment as factors, and ranked baseline value as a covariate.||Treatment Difference Fesoterodine vs placebo at Week 1. Per closed testing procedure, statistical testing for percent change not performed for Fesoterodine vs Tolterodine ER Week 1: corresponding numerical change result not statistically significant.||||0.0004
72327113|NCT00444925|144177753|SUPERIORITY_OR_OTHER|||||||0.0001||95.0||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with country and treatment as factors, and ranked baseline value as a covariate.||Treatment Difference Tolterodine ER vs placebo at Week 1. Per closed testing procedure, statistical testing for percent change not performed for Fesoterodine vs Tolterodine ER Week 1: corresponding numerical change result not statistically significant.||||0.0001
72419633|NCT01218126|144350204|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.95||||0.072||95.0|0.9|1.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Placebo versus Losmapimod 2.5 mg at Week 8||1.00|0.90|0.072
72419634|NCT01218126|144350204|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.9||||0|TWO_SIDED|95.0|0.85|0.95|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Placebo versus Losmapimod 7.5 mg at Week 8||0.95|0.85|0.000
72419635|NCT01218126|144350204|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.88||||0|TWO_SIDED|95.0|0.83|0.94|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Placebo versus Losmapimod 15 mg at Week 8||0.94|0.83|0.000
72419636|NCT01218126|144350204|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.99||||0.728|TWO_SIDED|95.0|0.93|1.05|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Placebo versus Losmapimod 2.5 mg at Week 12||1.05|0.93|0.728
72419637|NCT01218126|144350204|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.91||||0.002|TWO_SIDED|95.0|0.86|0.97|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Placebo versus Losmapimod 7.5 mg at Week 12||0.97|0.86|0.002
72419638|NCT01218126|144350204|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.9||||0.001|TWO_SIDED|95.0|0.84|0.95|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Placebo versus Losmapimod 15 mg at Week 12||0.95|0.84|0.001
72419639|NCT01218126|144350204|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.01||||0.823|TWO_SIDED|95.0|0.95|1.07|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Placebo versus Losmapimod 2.5 mg at Week 24||1.07|0.95|0.823
72419640|NCT01218126|144350204|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.96||||0.153|TWO_SIDED|95.0|0.9|1.02|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Placebo versus Losmapimod 7.5 mg at Week 24||1.02|0.90|0.153
72419641|NCT01218126|144350204|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.95||||0.126|TWO_SIDED|95.0|0.9|1.01|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Placebo versus Losmapimod 15 mg at Week 24||1.01|0.90|0.126
72419642|NCT01218126|144350205|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.87||||0.291|TWO_SIDED|95.0|0.68|1.12|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Placebo versus Losmapimod 2.5 mg at Week 4||1.12|0.68|0.291
72419643|NCT01218126|144350205|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.78||||0.046|TWO_SIDED|95.0|0.61|1.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Placebo versus Losmapimod 7.5 mg at Week 4||1.00|0.61|0.046
72419644|NCT01218126|144350205|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.73||||0.014|TWO_SIDED|95.0|0.57|0.94|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Placebo versus Losmapimod 15 mg at Week 4||0.94|0.57|0.014
72419645|NCT01218126|144350205|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.04||||0.755|TWO_SIDED|95.0|0.82|1.32|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Placebo versus Losmapimod 2.5 mg at Week 8||1.32|0.82|0.755
72419646|NCT01218126|144350205|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.77||||0.029|TWO_SIDED|95.0|0.6|0.97|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Placebo versus Losmapimod 7.5 mg at Week 8||0.97|0.60|0.029
72419647|NCT01218126|144350205|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.74||||0.015|TWO_SIDED|95.0|0.58|0.94|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Placebo versus Losmapimod 7.5 mg at Week 8||0.94|0.58|0.015
72419648|NCT01218126|144350205|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.91||||0.468|TWO_SIDED|95.0|0.71|1.17|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Placebo versus Losmapimod 2.5 mg at Week 12||1.17|0.71|0.468
72613478|NCT05523297|144755889|OTHER||Odds Ratio (OR)|1.31||||0.1742|TWO_SIDED|95.0|0.89|1.91|||Regression, Logistic|||Platelets (Within 24 hours after IMP start)||1.91|0.89|0.1742
72613479|NCT05523297|144755889|OTHER||Odds Ratio (OR)|1.4||||0.4618|TWO_SIDED|95.0|0.58|3.38|||Regression, Logistic|||Cryoprecipitate (Within 24 hours after IMP start)||3.38|0.58|0.4618
72613480|NCT05523297|144755889|OTHER||Odds Ratio (OR)|1.69||||0.0129|TWO_SIDED|95.0|1.12|2.55|||Regression, Logistic|||Any individual ABP (Within 24 hours after IMP start)||2.55|1.12|0.0129
72613481|NCT05523297|144755889|OTHER||Odds Ratio (OR)|1.58||||0.3297|TWO_SIDED|95.0|0.63|3.94|||Regression, Logistic|||FP excluding IMP (Within 7 days after IMP start)||3.94|0.63|0.3297
72613482|NCT05523297|144755889|OTHER||Odds Ratio (OR)|1.82||||0.0049|TWO_SIDED|95.0|1.2|2.76|||Regression, Logistic|||RBCs (Within 7 days after IMP start)||2.76|1.20|0.0049
72327114|NCT00444925|144177753|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with country and treatment as factors, and ranked baseline value as a covariate.||Treatment Difference Fesoterodine vs placebo at Week 4. Per closed testing procedure, statistical testing for percent change not performed for Fesoterodine vs Tolterodine ER Week 4: corresponding numerical change result not statistically significant.||||<0.0001
72327115|NCT00444925|144177753|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with country and treatment as factors, and ranked baseline value as a covariate.||Treatment Difference Tolterodine ER vs placebo at Week 4. Per closed testing procedure, statistical testing for percent change not performed for Fesoterodine vs Tolterodine ER Week 4: corresponding numerical change result not statistically significant.||||<0.0001
72327116|NCT00444925|144177753|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with country and treatment as factors, and ranked baseline value as a covariate.||Treatment Difference Fesoterodine vs placebo at Week 12. Per closed testing procedure, statistical testing for percent change not performed for Fesoterodine vs Tolterodine ER Week 12: corresponding numerical change result not statistically significant.||||<0.0001
72327117|NCT00444925|144177753|SUPERIORITY_OR_OTHER|||||||0.0001||95.0||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with country and treatment as factors, and ranked baseline value as a covariate.||Treatment Difference Tolterodine ER vs placebo at Week 12. Per closed testing procedure, statistical testing for percent change not performed for Fesoterodine vs Tolterodine ER Week 12: corresponding numerical change result not statistically significant.||||0.0001
72327118|NCT00444925|144177754|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs placebo at Week 1.||||<0.0001
72327119|NCT00444925|144177754|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Tolterodine ER vs placebo at Week 1.||||<0.0001
72327120|NCT00444925|144177754|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.2||0.5581|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs Tolterodine ER at Week 1.||||0.5581
72327121|NCT00444925|144177754|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.2|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs placebo at Week 4.||||<0.0001
72419649|NCT01218126|144350205|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.73||||0.011||95.0|0.57|0.93|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Placebo versus Losmapimod 7.5 mg at Week 12||0.93|0.57|0.011
72419650|NCT01218126|144350205|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.64||||0|TWO_SIDED|95.0|0.5|0.82|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Placebo versus Losmapimod 15 mg at Week 12||0.82|0.50|0.000
72327122|NCT00444925|144177754|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Tolterodine ER vs placebo at Week 4.||||<0.0001
72419651|NCT01218126|144350205|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.95||||0.696|TWO_SIDED|95.0|0.74|1.22|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Placebo versus Losmapimod 2.5 mg at Week 24||1.22|0.74|0.696
72419652|NCT01218126|144350205|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.81||||0.099|TWO_SIDED|95.0|0.64|1.04|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Placebo versus Losmapimod 7.5 mg at Week 24||1.04|0.64|0.099
72327123|NCT00444925|144177754|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.2||0.151|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs Tolterodine ER at Week 4.||||0.1510
72613483|NCT05523297|144755889|OTHER||Odds Ratio (OR)|1.26||||0.2417|TWO_SIDED|95.0|0.86|1.84|||Regression, Logistic|||Platelets (Within 7 days after IMP start)||1.84|0.86|0.2417
72613484|NCT05523297|144755889|OTHER||Odds Ratio (OR)|1.4||||0.4618|TWO_SIDED|95.0|0.58|3.38|||Regression, Logistic|||Cryoprecipitate (Within 7 days after IMP start)||3.38|0.58|0.4618
72327124|NCT00444925|144177754|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.1|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs placebo at Week 12.||||<0.0001
72327125|NCT00444925|144177754|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9|STANDARD_ERROR_OF_MEAN|0.2||0.0001|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Tolterodine ER vs placebo at Week 12.||||0.0001
72327126|NCT00444925|144177754|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.2||0.1391|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs Tolterodine ER at Week 12.||||0.1391
72327127|NCT00444925|144177755|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with country and treatment as factors, and ranked baseline value as a covariate.||Treatment Difference Fesoterodine vs placebo at Week 1. Per closed testing procedure, statistical testing for percent change not performed for Fesoterodine vs Tolterodine ER Week 1: corresponding numerical change result not statistically significant.||||<0.0001
72327128|NCT00444925|144177755|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with country and treatment as factors, and ranked baseline value as a covariate.||Treatment Difference Tolterodine ER vs placebo at Week 1. Per closed testing procedure, statistical testing for percent change not performed for Fesoterodine vs Tolterodine ER Week 1: corresponding numerical change result not statistically significant.||||<0.0001
72327129|NCT00444925|144177755|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with country and treatment as factors, and ranked baseline value as a covariate.||Treatment Difference Fesoterodine vs placebo at Week 4. Per closed testing procedure, statistical testing for percent change not performed for Fesoterodine vs Tolterodine ER Week 4: corresponding numerical change result not statistically significant.||||<0.0001
72327130|NCT00444925|144177755|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with country and treatment as factors, and ranked baseline value as a covariate.||Treatment Difference Tolterodine ER vs placebo at Week 4. Per closed testing procedure, statistical testing for percent change not performed for Fesoterodine vs Tolterodine ER Week 4: corresponding numerical change result not statistically significant.||||<0.0001
72327131|NCT00444925|144177755|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with country and treatment as factors, and ranked baseline value as a covariate.||Treatment Difference Fesoterodine vs placebo at Week 12. Per closed testing procedure, statistical testing for percent change not performed for Fesoterodine vs Tolterodine ER Week 12: corresponding numerical change result not statistically significant.||||<0.0001
72327132|NCT00444925|144177755|SUPERIORITY_OR_OTHER|||||||0.0001||95.0||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with country and treatment as factors, and ranked baseline value as a covariate.||Treatment Difference Tolterodine ER vs placebo at Week 12. Per closed testing procedure, statistical testing for percent change not performed for Fesoterodine vs Tolterodine ER Week 12: corresponding numerical change result not statistically significant.||||0.0001
72327133|NCT00444925|144177756|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.0|<|0.0001|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs placebo at Week 1.||||<0.0001
72419653|NCT01218126|144350205|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.86||||0.256|TWO_SIDED|95.0|0.67|1.11|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Placebo versus Losmapimod 15 mg at Week 24||1.11|0.67|0.256
72419654|NCT01218126|144350206|SUPERIORITY_OR_OTHER||Rate ratio|1.0||||0.989|TWO_SIDED|95.0|0.64|1.54|||Negative Binomial regression model|Covariates of treatment, group, smoking status, history of exacerbations and region, with logarithm of time on treatment as an offset variable.|Rate ratio= (Rate of exacerbation in Losmapimod 2.5 mg arm) / (Rate of exacerbation in placebo arm)|Losmapimod 2.5 mg versus Placebo||1.54|0.64|0.989
72419655|NCT01218126|144350206|SUPERIORITY_OR_OTHER||Rate ratio|0.98||||0.915||95.0|0.64|1.5|||Negative Binomial regression model|Covariates of treatment, group, smoking status, history of exacerbations and region, with logarithm of time on treatment as an offset variable.|Rate ratio= (Rate of exacerbation in Losmapimod 7.5 mg arm) / (Rate of exacerbation in placebo arm)|Placebo versus Losmapimod 7.5 mg||1.50|0.64|0.915
72613485|NCT05523297|144755889|OTHER||Odds Ratio (OR)|1.56||||0.0564|TWO_SIDED|95.0|0.99|2.47|||Regression, Logistic|||Any individual ABP (Within 7 days after IMP start)||2.47|0.99|0.0564
72419656|NCT01218126|144350206|SUPERIORITY_OR_OTHER||Rate ratio|0.74||||0.21|TWO_SIDED|95.0|0.47|1.18|||Negative Binomial regression model|Covariates of treatment, group, smoking status, history of exacerbations and region, with logarithm of time on treatment as an offset variable.|Rate ratio= (Rate of exacerbation in Losmapimod 15 mg arm) / (Rate of exacerbation in placebo arm)|Placebo versus Losmapimod 15 mg||1.18|0.47|0.210
72419657|NCT01165775|144350253|SUPERIORITY_OR_OTHER|||||||0.2155|||||||Chi-squared|||||||0.2155
72613486|NCT05523297|144755890|OTHER||Odds Ratio (OR)|1.1||||0.6956|TWO_SIDED|95.0|0.69|1.73|||Regression, Logistic|||Fibrinogen concentrate (Within 24 hours after IMP start)||1.73|0.69|0.6956
72613487|NCT05523297|144755890|OTHER||Odds Ratio (OR)|5.337||||0.0317|TWO_SIDED|95.0|1.12|50.7|||Regression, Logistic|||||50.70|1.12|0.0317
72613488|NCT05523297|144755890|OTHER||Odds Ratio (OR)|18.88|||<|0.0001|TWO_SIDED|95.0|2.9|796.37|||Regression, Logistic|||PCC excluding IMP (Within 24 hours after IMP start)||796.37|2.90|<0.0001
72613489|NCT05523297|144755890|OTHER||Odds Ratio (OR)|1.334||||0.1981|TWO_SIDED|95.0|0.86|2.07|||Regression, Logistic|||Any coagulation factor product (Within 24 hours after IMP start)||2.07|0.86|0.1981
72613490|NCT05523297|144755890|OTHER||Odds Ratio (OR)|1.187||||0.4599|TWO_SIDED|95.0|0.75|1.87|||Regression, Logistic|||Fibrinogen concentrate (Within 7 days after IMP start)||1.87|0.75|0.4599
72613491|NCT05523297|144755890|OTHER||Odds Ratio (OR)|5.337||||0.0317|TWO_SIDED|95.0|1.12|50.7|||Regression, Logistic|||rFVIIa (Within 7 days after IMP start)||50.70|1.12|0.0317
72613492|NCT05523297|144755890|OTHER||Odds Ratio (OR)|18.88|||<|0.0001|TWO_SIDED|95.0|2.9|796.37|||Regression, Logistic|||PCC excluding IMP (Within 7 days after IMP start)||796.37|2.90|<0.0001
72613493|NCT05523297|144755890|OTHER||Odds Ratio (OR)|1.431||||0.1073|TWO_SIDED|95.0|0.93|2.21|||Regression, Logistic|||Any coagulation factor product (Within 7 days after IMP start)||2.21|0.93|0.1073
72613494|NCT05523297|144755893|OTHER||Odds Ratio (OR)|1.435||||0.3782|TWO_SIDED|95.0|0.6429|3.2013|||Regression, Logistic|||Within 24 hours after CPB end||3.2013|0.6429|0.3782
72613495|NCT05523297|144755893|OTHER||Odds Ratio (OR)|1.435||||0.3782|TWO_SIDED|95.0|0.6429|3.2013|||Regression, Logistic|||Within 24 hours after IMP start||3.2013|0.6429|0.3782
72613496|NCT05523297|144755893|OTHER||Odds Ratio (OR)|1.332||||0.4899|TWO_SIDED|95.0|0.5902|3.0062|||Regression, Logistic|||Within 24 hours after surgery start||3.0062|0.5902|0.4899
72613497|NCT05523297|144755894|OTHER||Least Squares Mean Difference|-0.15||||0.0081|TWO_SIDED|95.0|-0.26|-0.04|||ANOVA|||||-0.04|-0.26|0.0081
72327134|NCT00444925|144177756|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.0|<|0.0001|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Tolterodine ER vs placebo at Week 1.||||<0.0001
72613498|NCT05523297|144755895|OTHER||Least Squares Mean Difference|-9.63||||0.6735|TWO_SIDED|95.0|-60.45|41.18|||ANOVA|||||41.18|-60.45|0.6735
72419658|NCT04791761|144350283|SUPERIORITY|||||||0.8|||||||t-test, 2 sided|||Null hypothesis: No difference in average pain scores before medication between opioid and non-opioid groups.||||0.8
72613499|NCT05523297|144755896|OTHER||Least Squares Mean Difference|-17.93||||0.9033|TWO_SIDED|95.0|-450.13|414.28|||ANOVA|||||414.28|-450.13|0.9033
72419659|NCT04791761|144350283|SUPERIORITY|||||||0.7|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: No difference in average pain scores after medication between opioid and non-opioid groups.||||0.7
72613500|NCT05523297|144755897|OTHER||Least Squares Mean Difference|-0.41||||0.1808|TWO_SIDED|95.0|-1.1|0.29|||ANOVA|||||0.29|-1.10|0.1808
72613501|NCT05523297|144755898|OTHER||Least Squares Mean Difference|0.28||||0.9698|TWO_SIDED|95.0|-14.78|15.34|||ANOVA|||||15.34|-14.78|0.9698
72613502|NCT05523297|144755899|OTHER||Least Squares Mean Difference|-3.1||||0.3363|TWO_SIDED|95.0|-9.61|3.42|||ANOVA|||||3.42|-9.61|0.3363
72613503|NCT05523297|144755900|OTHER||Least Squares Mean Difference|2.42||||0.5736|TWO_SIDED|95.0|-6.33|11.16|||ANOVA|||||11.16|-6.33|0.5736
72613504|NCT05523297|144755901|OTHER||Least Squares Mean Difference|-13.19||||0.2667|TWO_SIDED|95.0|-37.05|10.67|||ANOVA|||||10.67|-37.05|0.2667
72613505|NCT05523297|144755902|OTHER||Least Squares Mean Difference|12.25||||0.0658|TWO_SIDED|95.0|-0.87|25.38|||ANOVA|||||25.38|-0.87|0.0658
72613506|NCT05523297|144755903|OTHER||Least Squares Mean Difference|-0.19||||0.0726|TWO_SIDED|95.0|-0.4|0.02|||ANOVA|||||0.02|-0.40|0.0726
72613507|NCT05523297|144755908|OTHER||Odds Ratio (OR)|1.183||||0.7497|TWO_SIDED|95.0|0.4211|3.3235|||Regression, Logistic|||||3.3235|0.4211|0.7497
72613508|NCT04133909|144755965|SUPERIORITY||Rate ratio (Mepolizumab 100 mg/Placebo)|0.79||||0.011|TWO_SIDED|95.0|0.66|0.94|||Negative binomial model|||Analysis performed using a negative binomial model with covariates of treatment group, geographic region, number of moderate/severe exacerbations in previous year (less than or equal to \[\<=\]2, 3, \>=4 as ordinal), baseline percent (%) predicted Forced expiratory volume in one second (FEV1) and smoking status (current vs. former smoker), and with logarithm (time on- and off-treatment) as an offset variable.||0.94|0.66|0.011
72613509|NCT04133909|144755966|SUPERIORITY||Hazard Ratio (HR)|0.77||||0.009|TWO_SIDED|95.0|0.64|0.93|||Cox Proportional Hazards Model|||Estimated from a Cox Proportional Hazards Model with covariates of treatment group, geographic region, number of moderate or severe exacerbations in previous year \<=2, 3, \>=4 as ordinal), baseline % predicted FEV1 and smoking status (current vs former).||0.93|0.64|0.009
72327135|NCT00444925|144177756|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.0||0.5972|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs Tolterodine ER at Week 1.||||0.5972
72327136|NCT00444925|144177756|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.0|<|0.0001|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs placebo at Week 4.||||<0.0001
72327137|NCT00444925|144177756|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.0|<|0.0001|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Tolterodine ER vs placebo at Week 4.||||<0.0001
72327138|NCT00444925|144177756|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.0||0.1267|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs Tolterodine ER at Week 4.||||0.1267
72327139|NCT00444925|144177756|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs placebo at Week 12.||||<0.0001
72327140|NCT00444925|144177756|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Tolterodine ER vs placebo at Week 12.||||<0.0001
72327141|NCT00444925|144177756|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.0||0.0289|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs Tolterodine ER at Week 12.||||0.0289
72327142|NCT00444925|144177757|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.1|STANDARD_ERROR_OF_MEAN|0.7|<|0.0001|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs placebo at Week 1.||||<0.0001
72327143|NCT00444925|144177757|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.3|STANDARD_ERROR_OF_MEAN|0.7|<|0.0001|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Tolterodine ER vs placebo at Week 1.||||<0.0001
72327144|NCT00444925|144177757|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|0.6||0.7288|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs Tolterodine ER at Week 1.||||0.7288
72327145|NCT00444925|144177757|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.7|STANDARD_ERROR_OF_MEAN|0.8|<|0.0001|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs placebo at Week 4.||||<0.0001
72327146|NCT00444925|144177757|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.0|STANDARD_ERROR_OF_MEAN|0.8|<|0.0001|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Tolterodine ER vs placebo at Week 4.||||<0.0001
72327147|NCT00444925|144177757|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|0.6||0.2473|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs Tolterodine ER at Week 4.||||0.2473
72419660|NCT04791761|144350284|SUPERIORITY|||||||0.2|||||||Fisher Exact|||Null hypothesis: There will be no difference in the proportion of patients visiting the emergency department or urgent care post-operatively between opioid and non-opioid groups.||||0.2
72327148|NCT00444925|144177757|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.9|STANDARD_ERROR_OF_MEAN|0.8|<|0.0001|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs placebo at Week 12.||||<0.0001
72327149|NCT00444925|144177757|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.8|STANDARD_ERROR_OF_MEAN|0.8|<|0.0001|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Tolterodine ER vs placebo at Week 12.||||<0.0001
72327150|NCT00444925|144177757|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.1|STANDARD_ERROR_OF_MEAN|0.7||0.1047|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs Tolterodine ER at Week 12.||||0.1047
72419661|NCT03315143|144350299|SUPERIORITY||Hazard Ratio (HR)|0.74|||<|0.001|TWO_SIDED|95.0|0.63|0.88|||Cox proportional hazards model|||The estimates of the hazard ratio (HR) and corresponding 2-sided 95% confidence interval (CI) was to be provided by a marginal Cox proportional hazard model stratified by region and ejection fraction, with non-cardiovascular (non-CV) death treated as a competing event.||0.88|0.63|<0.001
72613510|NCT04133909|144755967|SUPERIORITY||Odds Ratio (OR)|0.81||||0.161|TWO_SIDED|95.0|0.6|1.09|||Regression, Logistic|||A logistic regression model was used to compare the proportion of responders between the mepolizumab and placebo arms in the mITT and mITT2 populations. The model includes fixed categorical covariates (treatment group, smoking status, geographic region) and a fixed continuous covariate (baseline score).||1.09|0.60|0.161
72613511|NCT04133909|144755968|SUPERIORITY||Odds Ratio (OR)|1.17||||0.291|TWO_SIDED|95.0|0.87|1.57|||Regression, Logistic|||A logistic regression model was used to compare the proportion of responders between the mepolizumab and placebo arms in the mITT and mITT2 populations. The model includes fixed categorical covariates (treatment group, smoking status, geographic region) and a fixed continuous covariate (baseline score).||1.57|0.87|0.291
72613512|NCT04133909|144755969|SUPERIORITY||Odds Ratio (OR)|0.82||||0.209|TWO_SIDED|95.0|0.6|1.12|||Regression, Logistic|||A logistic regression model was used to compare the proportion of responders between the mepolizumab and placebo arms in the mITT and mITT2 populations. The model includes fixed categorical covariates (treatment group, smoking status, geographic region) and a fixed continuous covariate (baseline score).||1.12|0.60|0.209
72613513|NCT04133909|144755970|SUPERIORITY||Rate ratio (Mepolizumab 100/Placebo)|0.65||||0.032|TWO_SIDED|95.0|0.43|0.96|||Negative binomial model|||Analysis performed using a negative binomial model with covariates of treatment group, geographic region, number of moderate/severe exacerbations in previous year (\<=2, 3, \>=4 as ordinal), baseline % predicted FEV1 and smoking status (current vs. former smoker), and with logarithm (time on- and off-treatment) as an offset variable. Estimates based on weighting applied to each level of class variable determined from observed proportions.||0.96|0.43|0.032
72613514|NCT01299909|144755972|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.53||||0.35|TWO_SIDED|95.0|0.67|3.51|||Regression, Logistic|||||3.51|0.67|0.35
72613515|NCT01299909|144755973|SUPERIORITY||Mean Difference (Final Values)|4.81||||0.03|TWO_SIDED||||||ANOVA|df=(1,57)||||||0.03
72613516|NCT01299909|144755974|SUPERIORITY||Mean Difference (Final Values)|6.09||||0.02|TWO_SIDED||||||ANOVA|df=(1,57)||||||0.02
72613517|NCT01299909|144755975|SUPERIORITY||Mean Difference (Final Values)|4.96||||0.03|TWO_SIDED||||||ANOVA|df=(1,57)||||||0.03
72613518|NCT05352763|144756041|OTHER|No statistical analysis performed|||||||||||||||||The classical summary of count and percentages will be provided for basic safety tabulations and dispositions as appropriate. All data will be presented in by-subject data listings. No inferential statistics will be produced.|||
72613519|NCT02469233|144756132|SUPERIORITY||Time by treatment interaction coeff.|-3.18||||0.025|TWO_SIDED||||||Intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||Treatment effect on change from pre to post, which is 9-14 weeks after the beginning of treatment.||||0.025
72613520|NCT02469233|144756132|SUPERIORITY||Time by treatment interaction coeff.|-1.52||||0.28|TWO_SIDED||||||Intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||Treatment effect on change from pre to 6-month follow-up||||0.28
72613521|NCT02469233|144756133|SUPERIORITY||time by treatment interaction coeff.|-5.88||||0.001|TWO_SIDED||||||Intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||Treatment effect on change from pre to post, which is 9-14 weeks after the beginning of treatment.||||0.001
72613522|NCT02469233|144756133|SUPERIORITY||maximum likelihood estimation|-3.9||||0.03|TWO_SIDED||||||Intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||Treatment effect on change from pre to 6-month follow-up||||0.03
72613523|NCT02469233|144756134|SUPERIORITY||time by treatment interaction coeff.|-5.55|||<|0.0001|TWO_SIDED||||||Intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||Treatment effect on change from pre to post, which is 9-14 weeks after the beginning of treatment.||||<0.0001
72613524|NCT02469233|144756134|SUPERIORITY||Time by treatment interaction coeff.|-4.92|||<|0.0001|TWO_SIDED||||||Intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||Treatment effect on change from pre to 6-month follow-up||||<0.0001
72613525|NCT02469233|144756135|SUPERIORITY||Time by treatment interaction coeff.|-9.14|||<|0.0001|TWO_SIDED||||||Intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||Treatment effect on change from pre to post, which is 9-14 weeks after the beginning of treatment.||||<0.0001
72613526|NCT02469233|144756135|SUPERIORITY||Time by treatment interaction coeff.|-5.37||||0.027|TWO_SIDED||||||Intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||Treatment effect on change from pre to 6-month follow-up||||0.027
72613527|NCT02469233|144756136|SUPERIORITY||Time by treatment interaction coeff.|-0.95||||0.32|TWO_SIDED||||||Intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||Treatment effect on change from pre to post, which is 9-14 weeks after the beginning of treatment.||||0.32
72613528|NCT02469233|144756136|SUPERIORITY||Time by treatment interaction coeff.|-1.67||||0.08|TWO_SIDED||||||Intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||Treatment effect on change from pre to 6-month follow-up||||0.08
72613529|NCT02469233|144756137|SUPERIORITY||Time by treatment interaction coeff.|-0.09||||0.72|TWO_SIDED||||||intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||Treatment effect on change from pre to post, which is 9-14 weeks after the beginning of treatment.||||0.72
72327151|NCT00444925|144177758|SUPERIORITY_OR_OTHER|||||||0.0143||95.0|||||Cochran-Mantel-Haenszel|With modified ridit scoring and stratified by country.||Fesoterodine vs placebo at Week 1||||0.0143
72327152|NCT00444925|144177758|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Cochran-Mantel-Haenszel|With modified ridit scoring and stratified by country.||Fesoterodine vs placebo at Week 4||||<0.0001
72327153|NCT00444925|144177758|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Cochran-Mantel-Haenszel|With modified ridit scoring and stratified by country.||Fesoterodine vs placebo at Week 12||||<0.0001
72327154|NCT00444925|144177759|SUPERIORITY_OR_OTHER|||||||0.0773||95.0|||||Cochran-Mantel-Haenszel|With modified ridit scoring and stratified by country.||Fesoterodine vs placebo at Week 1||||0.0773
72327155|NCT00444925|144177759|SUPERIORITY_OR_OTHER|||||||0.0017||95.0|||||Cochran-Mantel-Haenszel|With modified ridit scoring and stratified by country.||Fesoterodine vs placebo at Week 4||||0.0017
72327156|NCT00444925|144177759|SUPERIORITY_OR_OTHER|||||||0.0008||95.0|||||Cochran-Mantel-Haenszel|With modified ridit scoring and stratified by country.||Fesoterodine vs placebo at Week 12||||0.0008
72327157|NCT00444925|144177760|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.8|STANDARD_ERROR_OF_MEAN|1.5|<|0.0001|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment difference Fesoterodine vs placebo at Week 12||||<0.0001
72327158|NCT00444925|144177761|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.2|STANDARD_ERROR_OF_MEAN|1.6|<|0.0001|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs placebo: HRQL concern domain.||||<0.0001
72327159|NCT00444925|144177761|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.6|STANDARD_ERROR_OF_MEAN|1.6|<|0.0001|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs placebo: HRQL coping domain.||||<0.0001
72327160|NCT00444925|144177761|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.0|STANDARD_DEVIATION|1.5||0.0008|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs placebo: HRQL sleep domain.||||0.0008
72327161|NCT00444925|144177761|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.8|STANDARD_ERROR_OF_MEAN|1.2|<|0.0001|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs placebo: HRQL social interaction domain.||||<0.0001
72419662|NCT03315143|144350300|SUPERIORITY||Hazard Ratio (HR)|0.67|||<|0.001|TWO_SIDED|95.0|0.55|0.82|||Cox proportional hazards model|||The estimates of the HR and corresponding 2-sided 95% CI was to be provided by a marginal Cox proportional hazard model stratified by region and ejection fraction, with non-CV death treated as a competing event.||0.82|0.55|<0.001
72327162|NCT00444925|144177761|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.3|STANDARD_ERROR_OF_MEAN|1.3|<|0.0001|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs placebo: HRQL scale score total.||||<0.0001
72327163|NCT00444925|144177762|SUPERIORITY_OR_OTHER|||||||0.0072||95.0|||||Cochran-Mantel-Haenszel|Stratified by baseline urgency urinary incontinence quartile.||Treatment Difference Fesoterodine vs placebo at Week 1.||||0.0072
72419663|NCT03315143|144350301|SUPERIORITY||Hazard Ratio (HR)|0.9|||=|0.35|TWO_SIDED|95.0|0.73|1.12|||Cox proportional hazards model|||The estimates of the HR and corresponding 2-sided 95% CI was to be provided by a marginal Cox proportional hazard model stratified by region and ejection fraction, with non-CV death treated as a competing event.||1.12|0.73|=0.35
72419664|NCT03315143|144350302|SUPERIORITY||Hazard Ratio (HR)|0.72|||||TWO_SIDED|95.0|0.63|0.83||||||The estimates of the HR and corresponding 2-sided 95% CI was to be provided by a marginal Cox proportional hazard model stratified by region and ejection fraction, with non-CV death treated as a competing event.||0.83|0.63|
72327164|NCT00444925|144177762|SUPERIORITY_OR_OTHER|||||||0.0116||95.0|||||Cochran-Mantel-Haenszel|Stratified by baseline urgency urinary incontinence quartile.||Treatment Difference Tolterodine ER vs placebo at Week 1.||||0.0116
72327165|NCT00444925|144177762|SUPERIORITY_OR_OTHER|||||||0.7828||95.0|||||Cochran-Mantel-Haenszel|Stratified by baseline urgency urinary incontinence quartile.||Treatment Difference Fesoterodine vs Tolterodine ER at Week 1.||||0.7828
72327166|NCT00444925|144177762|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Cochran-Mantel-Haenszel|Stratified by baseline urgency urinary incontinence quartile.||Treatment Difference Fesoterodine vs placebo at Week 4.||||<0.0001
72419665|NCT03315143|144350303|SUPERIORITY||Hazard Ratio (HR)|0.76|||||TWO_SIDED|95.0|0.65|0.89||||||The estimates of the HR and corresponding 2-sided 95% CI was to be provided by a marginal Cox proportional hazard model stratified by region and ejection fraction, with non-CV death treated as a competing event.||0.89|0.65|
72327167|NCT00444925|144177762|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Cochran-Mantel-Haenszel|Stratified by baseline urgency urinary incontinence quartile.||Treatment Difference Tolterodine ER vs placebo at Week 4.||||<0.0001
72327168|NCT00444925|144177762|SUPERIORITY_OR_OTHER|||||||0.3104||95.0|||||Cochran-Mantel-Haenszel|Stratified by baseline urgency urinary incontinence quartile.||Treatment Difference Fesoterodine vs Tolterodine ER at Week 4.||||0.3104
72327169|NCT00444925|144177762|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Cochran-Mantel-Haenszel|Stratified by baseline urgency urinary incontinence quartile.||Treatment Difference Fesoterodine vs placebo at Week 12.||||<0.0001
72327170|NCT00444925|144177762|SUPERIORITY_OR_OTHER|||||||0.0004||95.0|||||Cochran-Mantel-Haenszel|Stratified by baseline urgency urinary incontinence quartile.||Treatment Difference Tolterodine ER vs placebo at Week 12.||||0.0004
72419666|NCT03315143|144350304|SUPERIORITY||Hazard Ratio (HR)|0.71|||||TWO_SIDED|95.0|0.46|1.08||||||The estimates of the HR and corresponding 2-sided 95% CI was to be provided by a marginal Cox proportional hazard model stratified by region and ejection fraction, with non-CV death treated as a competing event.||1.08|0.46|
72327171|NCT00444925|144177762|SUPERIORITY_OR_OTHER|||||||0.0153||95.0|||||Cochran-Mantel-Haenszel|Stratified by baseline urgency urinary incontinence quartile.||Treatment Difference Fesoterodine vs Tolterodine ER at Week 12.||||0.0153
72327172|NCT03382912|144177788|SUPERIORITY||Odds Ratio (OR)|1.2|||||TWO_SIDED|95.0|0.3|5.9|||||Odds Ratio stratified based on tumor histology at randomization (interactive web response system (IWRS)), smoking status (IWRS). Confidence intervals were based on the Clopper-Pearson method.|||5.9|0.3|
72327173|NCT03382912|144177789|SUPERIORITY||Hazard Ratio (HR)|1.006|||||TWO_SIDED|95.0|0.519|1.951|||||The estimate of the hazard ration (HR) stratified based on tumor histology at randomization (interactive web response system (IWRS)) and smoking status (IWRS).|||1.951|0.519|
72327174|NCT03382912|144177790|SUPERIORITY||Hazard Ratio (HR)|1.871|||||TWO_SIDED|95.0|0.772|4.532|||||||The estimate of the hazard ration (HR) stratified based on tumor histology at randomization (IWRS) and smoking status (IWRS).|4.532|0.772|
72327175|NCT03382912|144177791|SUPERIORITY||Odds Ratio (OR)|1.3|||||TWO_SIDED|95.0|0.4|4.1|||||Odds Ratio stratified based on tumor histology at randomization (IWRS) and smoking status (IWRS). Confidence intervals were based on the Clopper-Pearson method.|||4.1|0.4|
72327176|NCT00707993|144177824|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.05|||||ONE_SIDED|97.5||0.13|||ANCOVA|Treatment, randomization schedule, and geographic region as class effects; baseline value for the endpoint as a continuous covariate.||Primary null hypothesis: the average Week 52 HbA1c change from Baseline for alogliptin is inferior to that for glipizide (1-sided 97.5% CI \[alpha=0.025\] compared to non-inferiority margin of 0.4%). If the primary null hypothesis was rejected (non-inferiority demonstrated), an additional comparison for statistical superiority of alogliptin was performed. The CI was re-evaluated; statistical superiority declared if the upper limit was \< 0%.||0.13||
72327177|NCT02137070|144177861|SUPERIORITY||||||<|0.01||||||Voxel-size (p-FWE \< 0.01) and voxel-peak (p-unc \< 0.001) were corrected for multiple comparisons.|2x2 Factorial ANOVA in CONN|2x2 Factorial ANOVA in CONN - Group (Bariatric surgery vs. control) \& time (pre-surgery baseline vs. 18-month follow-up)||Analysis of variance comparing change scores from 18 months post-surgery relative to pre-surgical baseline were performed. Change in the surgical group was compared to change for the non-surgical controls. The dependent measures were connectivity strengths seeding from the hippocampus and left dorsal lateral pre-frontal cortex to other cortical areas.||||<0.01
72327178|NCT00532129|144177881|SUPERIORITY_OR_OTHER||||||=|0.029|TWO_SIDED||||||t-test, 2 sided|||CFB in GHS/QoL statistical analysis at Cycle 5.||||=0.029
72327179|NCT00532129|144177881|SUPERIORITY_OR_OTHER||||||=|0.027|TWO_SIDED||||||t-test, 2 sided|||CFB in GHS/QoL statistical analysis at Cycle 11.||||=0.027
72327180|NCT00532129|144177881|SUPERIORITY_OR_OTHER||||||=|0.602|TWO_SIDED||||||t-test, 2 sided|||CFB in GHS/QoL statistical analysis at end of FU.||||=0.602
72327181|NCT00532129|144177881|SUPERIORITY_OR_OTHER||||||=|0.631|TWO_SIDED||||||t-test, 2 sided|||CFB in physical functioning statistical analysis at Cycle 5.||||=0.631
72327182|NCT00532129|144177881|SUPERIORITY_OR_OTHER||||||=|0.339|TWO_SIDED||||||t-test, 2 sided|||CFB in physical functioning statistical analysis at Cycle 11.||||=0.339
72327183|NCT00532129|144177881|SUPERIORITY_OR_OTHER||||||=|0.44|TWO_SIDED||||||t-test, 2 sided|||CFB in physical functioning statistical analysis at end of FU.||||=0.440
72327184|NCT00532129|144177881|SUPERIORITY_OR_OTHER||||||=|1|TWO_SIDED||||||t-test, 2 sided|||CFB in role functioning statistical analysis at Cycle 5.||||=1.000
72327185|NCT00532129|144177881|SUPERIORITY_OR_OTHER||||||=|0.465|TWO_SIDED||||||t-test, 2 sided|||CFB in role functioning statistical analysis at Cycle 11.||||=0.465
72327186|NCT00532129|144177881|SUPERIORITY_OR_OTHER||||||=|0.431|TWO_SIDED||||||t-test, 2 sided|||CFB in role functioning statistical analysis at end of FU.||||=0.431
72327187|NCT00532129|144177881|SUPERIORITY_OR_OTHER||||||=|0.65|TWO_SIDED||||||t-test, 2 sided|||CFB in emotional functioning statistical analysis at Cycle 5.||||=0.650
72327188|NCT00532129|144177881|SUPERIORITY_OR_OTHER||||||=|0.98|TWO_SIDED||||||t-test, 2 sided|||CFB in emotional functioning statistical analysis at Cycle 11.||||=0.980
72327189|NCT00532129|144177881|SUPERIORITY_OR_OTHER||||||=|0.906|TWO_SIDED||||||t-test, 2 sided|||CFB in emotional functioning statistical analysis at end of FU.||||=0.906
72327190|NCT00532129|144177881|SUPERIORITY_OR_OTHER||||||=|0.381|TWO_SIDED||||||t-test, 2 sided|||CFB in cognitive functioning statistical analysis at Cycle 5.||||=0.381
72327191|NCT00532129|144177881|SUPERIORITY_OR_OTHER||||||=|0.886|TWO_SIDED||||||t-test, 2 sided|||CFB in cognitive functioning statistical analysis at Cycle 11.||||=0.886
72327192|NCT00532129|144177881|SUPERIORITY_OR_OTHER||||||=|0.264|TWO_SIDED||||||t-test, 2 sided|||CFB in cognitive functioning statistical analysis at end of FU.||||=0.264
72327193|NCT00532129|144177881|SUPERIORITY_OR_OTHER||||||=|0.424|TWO_SIDED||||||t-test, 2 sided|||CFB in social functioning statistical analysis at Cycle 5.||||=0.424
72327194|NCT00532129|144177881|SUPERIORITY_OR_OTHER||||||=|1|TWO_SIDED||||||t-test, 2 sided|||CFB in social functioning statistical analysis at Cycle 11.||||=1.000
72327195|NCT00532129|144177881|SUPERIORITY_OR_OTHER||||||=|0.312|TWO_SIDED||||||t-test, 2 sided|||CFB in social functioning statistical analysis at end of FU.||||=0.312
72327196|NCT00532129|144177881|SUPERIORITY_OR_OTHER||||||=|0.664|TWO_SIDED||||||t-test, 2 sided|||CFB in fatigue statistical analysis at Cycle 5.||||=0.664
72327197|NCT00532129|144177881|SUPERIORITY_OR_OTHER||||||=|0.17|TWO_SIDED||||||t-test, 2 sided|||CFB in fatigue functioning statistical analysis at Cycle 11.||||=0.170
72327198|NCT00532129|144177881|SUPERIORITY_OR_OTHER||||||=|0.318|TWO_SIDED||||||t-test, 2 sided|||CFB in fatigue statistical analysis at end of FU.||||=0.318
72327199|NCT00532129|144177881|SUPERIORITY_OR_OTHER||||||=|0.536|TWO_SIDED||||||t-test, 2 sided|||CFB in Nausea/vomiting statistical analysis at Cycle 5.||||=0.536
72327200|NCT00532129|144177881|SUPERIORITY_OR_OTHER||||||=|0.9|TWO_SIDED||||||t-test, 2 sided|||CFB in nausea/vomiting statistical analysis at Cycle 11.||||=0.900
72327201|NCT00532129|144177881|SUPERIORITY_OR_OTHER||||||=|0.188|TWO_SIDED||||||t-test, 2 sided|||CFB in nausea/vomiting statistical analysis at end of FU.||||=0.188
72327202|NCT00532129|144177881|SUPERIORITY_OR_OTHER||||||=|0.37|TWO_SIDED||||||t-test, 2 sided|||CFB in pain statistical analysis at Cycle 5.||||=0.370
72327203|NCT00532129|144177881|SUPERIORITY_OR_OTHER||||||=|0.813|TWO_SIDED||||||t-test, 2 sided|||CFB in pain statistical analysis at Cycle 11.||||=0.813
72327204|NCT00532129|144177881|SUPERIORITY_OR_OTHER||||||=|1|TWO_SIDED||||||t-test, 2 sided|||CFB in pain statistical analysis at end of FU.||||=1.000
72419667|NCT03315143|144350305|SUPERIORITY||Hazard Ratio (HR)|0.99|||||TWO_SIDED|95.0|0.83|1.18||||||The estimates of the HR and corresponding 2-sided 95% CI was to be provided by a marginal Cox proportional hazard model stratified by region and ejection fraction.||1.18|0.83|
72419668|NCT03315143|144350306|SUPERIORITY||Hazard Ratio (HR)|0.77|||||TWO_SIDED|95.0|0.65|0.91||||||The estimates of the HR and corresponding 2-sided 95% CI was to be provided by a marginal Cox proportional hazard model stratified by region and ejection fraction, with non-CV death treated as a competing event.||0.91|0.65|
72419669|NCT03086330|144350364|OTHER||Treatment difference|-1.42|||<|0.0001|TWO_SIDED|95.0|-1.61|-1.24|||ANCOVA|||The responses were analysed using an analysis of covariance (ANCOVA) with treatment, stratification factor and region as fixed factors and baseline value as covariate. Before analysis, missing data were multiple imputed using observed data from participants within the same group defined by randomised treatment, using a regression model including stratification factor and region as categorical effects and data from baseline and all previous visits as covariates.||-1.24|-1.61|<0.0001
72613530|NCT02469233|144756137|SUPERIORITY||Time by treatment interaction coeff.|-0.08||||0.74|TWO_SIDED||||||Intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||Treatment effect on change from pre to 6-month follow-up||||0.74
72613531|NCT02469233|144756138|SUPERIORITY||Time by treatment interaction coeff.|-2.46||||0.73|TWO_SIDED||||||Intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||Treatment effect on change from pre to post, which is 9-14 weeks after the beginning of treatment.||||0.73
72613532|NCT02469233|144756138|SUPERIORITY||Time by treatment interaction coeff.|-17.52||||0.02|TWO_SIDED||||||intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||Treatment effect on change from pre to 6-month follow-up||||0.02
72613533|NCT02469233|144756139|SUPERIORITY||Time by treatment interaction coeff.|5.68||||0.03|TWO_SIDED||||||Intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||SE mean (min): Treatment effect on change from pre to post, which is 9-14 weeks after the beginning of treatment.||||0.03
72613534|NCT02469233|144756139|SUPERIORITY||Time by treatment interaction coeff.|5.89||||0.03|TWO_SIDED||||||intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||SE mean (min): Treatment effect on change from pre to 6-month follow-up.||||0.03
72613535|NCT02469233|144756139|SUPERIORITY||Time by treatment interaction coeff.|-1.45||||0.43|TWO_SIDED||||||Intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||SE variability (min): Treatment effect on change from pre to post, which is 9-14 weeks after the beginning of treatment.||||0.43
72613536|NCT02469233|144756139|SUPERIORITY||Time by treatment interaction coeff.|-1.55||||0.4|TWO_SIDED||||||Intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||SE variability (min): Treatment effect on change from pre to 6-month follow-up.||||0.40
72613537|NCT02469233|144756140|SUPERIORITY||Time by treatment interaction coeff.|-12.68||||0.59|TWO_SIDED||||||Intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||TST mean (min): Treatment effect on change from pre to post, which is 9-14 weeks after the beginning of treatment.||||0.59
72613538|NCT02469233|144756140|SUPERIORITY||Time by treatment interaction coeff.|-28.33||||0.22|TWO_SIDED||||||Intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||TST mean (min): Treatment effect on change from pre to 6-month follow-up.||||0.22
72613539|NCT02469233|144756140|SUPERIORITY||Time by treatment interaction coeff.|4.65||||0.8|TWO_SIDED||||||Intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||TST variability (min) : Treatment effect on change from pre to post, which is 9-14 weeks after the beginning of treatment.||||0.80
72613540|NCT02469233|144756140|SUPERIORITY||Time by treatment interaction coeff.|-7.57||||0.68|TWO_SIDED||||||Intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||TST variability (min): Treatment effect on change from pre to 6-month follow-up.||||0.68
72613541|NCT02469233|144756141|SUPERIORITY||Time by treatment interaction coeff.|-76.85||||0.34|TWO_SIDED||||||Intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||Waking activity count mean (min): Treatment effect on change from pre to post, which is 9-14 weeks after the beginning of treatment.||||0.34
72613542|NCT02469233|144756141|SUPERIORITY||Time by treatment interaction coeff.|-87.15||||0.28|TWO_SIDED||||||Intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||Waking activity count mean (min): Treatment effect on change from pre to 6-month follow-up.||||0.28
72613543|NCT02469233|144756141|SUPERIORITY||Time by treatment interaction coeff.|-0.15||||0.18|TWO_SIDED||||||Intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||Waking activity count variability (min) : Treatment effect on change from pre to post, which is 9-14 weeks after the beginning of treatment.||||0.18
72613544|NCT02469233|144756141|SUPERIORITY||Time by treatment interaction coeff.|-0.27||||0.02|TWO_SIDED||||||Intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||Waking activity count variability (min): Treatment effect on change from pre to 6-month follow-up.||||0.02
72613545|NCT02469233|144756142|SUPERIORITY||Time by treatment interaction coeff.|-7.19||||0.09|TWO_SIDED||||||Intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||Treatment effect on change from pre to post, which is 9-14 weeks after the beginning of treatment.||||0.09
72613546|NCT02469233|144756142|SUPERIORITY||Time by treatment interaction coeff.|-1.13||||0.79|TWO_SIDED||||||Intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcome.||Treatment effect on change from pre to 6-month follow-up||||0.79
72613547|NCT02469233|144756143|SUPERIORITY||Time by treatment interaction coeff.|0.16||||0.46|TWO_SIDED||||||Intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcome,||Treatment effect on change from pre to post, which is 9-14 weeks after the beginning of treatment.||||0.46
72613548|NCT02469233|144756143|SUPERIORITY||Time by treatment interaction coeff.|-0.34||||0.1|TWO_SIDED||||||Intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||Treatment effect on change from pre to 6-month follow-up||||0.10
72613549|NCT02469233|144756144|SUPERIORITY||Time by treatment interaction coeff.|0.91||||0.002|TWO_SIDED||||||Intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||Treatment effect on change from pre to post, which is 9-14 weeks after the beginning of treatment.||||0.002
72613550|NCT02469233|144756144|SUPERIORITY||Time by treatment interaction coeff.|0.64||||0.03|TWO_SIDED||||||Intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||Treatment effect on change from pre to 6-month follow-up.||||0.03
72613551|NCT02469233|144756145|SUPERIORITY||Time by treatment interaction coeff.|24.85||||0.23|TWO_SIDED||||||Intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||Means of Total sleep time: Treatment effect on change from pre to post, which is 9-14 weeks after the beginning of treatment.||||0.23
72613552|NCT02469233|144756145|SUPERIORITY||Time by treatment interaction coeff.|34.31||||0.09|TWO_SIDED||||||Intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||Means of total sleep time: Treatment effect on change from pre to 6-month follow-up||||0.09
72613553|NCT02469233|144756145|SUPERIORITY||Time by treatment interaction coeff.|-19.9||||0.19|TWO_SIDED||||||Intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||Variability of Total sleep time: Treatment effect on change from pre to post, which is 9-14 weeks after the beginning of treatment.||||0.19
72613554|NCT02469233|144756145|SUPERIORITY||Time by treatment interaction coeff.|-1.76||||0.91|TWO_SIDED||||||Intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||Variability of Total sleep time: Treatment effect on change from pre to 6-month follow-up||||0.91
72613555|NCT02469233|144756146|SUPERIORITY||Time by treatment interaction coeff.|-39.33||||0.04|TWO_SIDED||||||Intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||TWT mean (min): Treatment effect on change from pre to post, which is 9-14 weeks after the beginning of treatment.||||0.04
72613556|NCT02469233|144756146|SUPERIORITY||Time by treatment interaction coeff.|-28.56||||0.13|TWO_SIDED||||||Intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||TWT mean (min): Treatment effect on change from pre to 6-month follow-up.||||0.13
72613557|NCT02469233|144756146|SUPERIORITY||Time by treatment interaction coeff.|-17.57||||0.21|TWO_SIDED||||||Intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||TWT variability (min) : Treatment effect on change from pre to post, which is 9-14 weeks after the beginning of treatment.||||0.21
72327205|NCT03427814|144177886|SUPERIORITY||||||=|0.1428|||||||Log Rank|The one-sided p-value was based on a stratified log-rank test.||||||= 0.1428
72419670|NCT03086330|144350365|OTHER||Treatment difference|-3.81|||<|0.0001|TWO_SIDED|95.0|-4.7|-2.93|||ANCOVA|||The responses were analysed using an ANCOVA with treatment, stratification factor and region as fixed factors and baseline value as covariate. Before analysis, missing data were multiple imputed using observed data from participants within the same group defined by randomised treatment, using a regression model including stratification factor and region as categorical effects and data from baseline and all previous visits as covariates.||-2.93|-4.70|<0.0001
72419671|NCT01446666|144350443|SUPERIORITY||||||<|0.01|||||||McNemar|||The HCC detection rate was defined as the number of patients with HCC detected by a given modality divided by the total number of patients with HCC detected by all modalities and by follow-up dynamic CT scan. The HCC detection rates from ultrasonography and MRI were compared.||||<0.01
72327206|NCT03846427|144177899|SUPERIORITY|P value was based on the exact binomial test against the null hypothesis of ORR = 30% with alternative of ORR \> 30%|||||<|0.0001|||||||Binomial exact method|||||||<0.0001
72419672|NCT01446666|144350444|SUPERIORITY||||||<|0.01|||||||McNemar|||||||<0.01
72419673|NCT01446666|144350445|SUPERIORITY||||||<|0.01|||||||McNemar|||||||<0.01
72419674|NCT01446666|144350446|SUPERIORITY|||||||0.004|||||||McNemar|||||||0.004
72419675|NCT01814748|144350451|SUPERIORITY_OR_OTHER||Difference in least squares means|0.12||||0.535|TWO_SIDED|95.0|-0.26|0.49|||Constrained longitudinal data analysis|Terms for treatment, time, and the interaction of time by treatment, with the constraint that the mean baseline is the same for all treatment groups.||||0.49|-0.26|0.535
72613558|NCT02469233|144756146|SUPERIORITY||Time by treatment interaction coeff.|-16.05||||0.25|TWO_SIDED||||||Intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||TWT variability (min): Treatment effect on change from pre to 6-month follow-up.||||0.25
72613559|NCT02469233|144756147|SUPERIORITY||Time by treatment interaction coeff.|-0.55||||0.1|TWO_SIDED||||||Intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||Bedtime (BT) mean: Treatment effect on change from pre to post, which is 9-14 weeks after the beginning of treatment.||||0.10
72613560|NCT02469233|144756147|SUPERIORITY||Time by treatment interaction coeff.|-0.71||||0.04|TWO_SIDED||||||Intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||BT mean: Treatment effect on change from pre to 6-month follow-up.||||0.04
72613561|NCT02469233|144756147|SUPERIORITY||Time by treatment interaction coeff.|-0.31||||0.2|TWO_SIDED||||||Intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||BT variability: Treatment effect on change from pre to post, which is 9-14 weeks after the beginning of treatment.||||0.20
72613562|NCT02469233|144756147|SUPERIORITY||Time by treatment interaction coeff.|-0.45||||0.07|TWO_SIDED||||||Intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||BT variability: Treatment effect on change from pre to 6-month follow-up.||||0.07
72613563|NCT02469233|144756148|SUPERIORITY||Time by treatment interaction coeff.|-0.33||||0.39|TWO_SIDED||||||Intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||WT mean: Treatment effect on change from pre to post, which is 9-14 weeks after the beginning of treatment.||||0.39
72613564|NCT02469233|144756148|SUPERIORITY||Time by treatment interaction coeff.|-0.02||||0.96|TWO_SIDED||||||Intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||WT mean: Treatment effect on change from pre to 6-month follow-up.||||0.96
72613565|NCT02469233|144756148|SUPERIORITY||Time by treatment interaction coeff.|-0.39||||0.047|TWO_SIDED||||||Intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||WT variability: Treatment effect on change from pre to post, which is 9-14 weeks after the beginning of treatment.||||0.047
72613566|NCT02469233|144756148|SUPERIORITY||Time by treatment interaction coeff.|0.2||||0.3|TWO_SIDED||||||Intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||WT variability: Treatment effect on change from pre to 6-month follow-up.||||0.30
72613567|NCT02469233|144756149|SUPERIORITY||Time by treatment interaction coeff.|-4.42||||0.66|TWO_SIDED||||||Intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||TWT mean (min): Treatment effect on change from pre to post, which is 9-14 weeks after the beginning of treatment.||||0.66
72613568|NCT02469233|144756149|SUPERIORITY||Time by treatment interaction coeff.|-13.34||||0.19|TWO_SIDED||||||Intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||TWT mean (min): Treatment effect on change from pre to 6-month follow-up.||||0.19
72613569|NCT02469233|144756149|SUPERIORITY||Time by treatment interaction coeff.|-0.05||||0.77|TWO_SIDED||||||Intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||TWT variability (min): Treatment effect on change from pre to post, which is 9-14 weeks after the beginning of treatment.||||0.77
72613570|NCT02469233|144756149|SUPERIORITY||Time by treatment interaction coeff.|-0.22||||0.2|TWO_SIDED||||||Intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||TWT variability (min): Treatment effect on change from pre to 6-month follow-up.||||0.20
72613571|NCT01787838|144756169|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.8|||<|0.0001|TWO_SIDED|95.0|1.65|1.96|||Chi-squared|||Prospective data from 12 months were compared to data that had been collected for the previous 12 month period to determine statistical significance and trended outcomes for comparative periods. Patients were screened for eligibility during the first 12 months, and staff and patients received the interventions during the second 12 month period.||1.96|1.65|<.0001
72613572|NCT01431976|144756170|SUPERIORITY_OR_OTHER||percentage of participants|35.0|||||TWO_SIDED|95.0|15.39|59.22||||||||59.22|15.39|
72613573|NCT00782067|144756187|OTHER|Single arm study|||||<|0.001|TWO_SIDED|95.0||||Null hypothesis: ORR \<= 30% Alternative hypothesis: ORR \>= 50%|Exact Binomial Test||||Exact Binomial 95% Confidence Interval|||<0.001
72613574|NCT01970371|144756196|SUPERIORITY|The 2-sided 90% confidence interval (CI) for the difference between groups in Cohort 1 (colistin minus plazomicin) is based on the unconditional exact method.|Difference Estimate|26.5|||||TWO_SIDED|90.0|-0.7|51.2|||1-sided Fisher's exact test|||||51.2|-0.7|
72613575|NCT01970371|144756197|SUPERIORITY|The 2-sided 90% confidence interval (CI) for the difference between groups in Cohort 1 (colistin minus plazomicin) is based on the unconditional exact method.|Difference Estimate|28.2|||||TWO_SIDED|90.0|0.7|52.5|||1-sided Fisher's exact test|||||52.5|0.7|
72327207|NCT01693250|144177925|SUPERIORITY||Mean Difference (Final Values)|1.68|STANDARD_DEVIATION|0.5|<|0.001|TWO_SIDED|95.0|||||Mixed Models Analysis|||This is a feasibility and pilot study. We acknowledge that our sample size will not have adequate power to detect any statistically significant outcomes. We chose a sample size that would be large enough to assess feasibility and effect size and to accommodate recruitment within the study time and budget of this application. We hope to be able to estimate the effect size of the intervention.||||<.001
72327208|NCT01693250|144177926|SUPERIORITY||Mean Difference (Final Values)|2.66||||0.001|TWO_SIDED|95.0|||||Mixed Models Analysis|||We hypothesized the intervention group will have significant reduction of systematic blood pressure compared to the control group at 6 month follow up.||||.001
72327209|NCT04971967|144177953|SUPERIORITY|||||||0.07|||||||Generalized linear regression|||||||0.07
72327210|NCT04971967|144177954|SUPERIORITY|||||||0.3|||||||Generalized linear regression|||||||0.30
72327211|NCT04971967|144177956|SUPERIORITY|||||||0.28|||||||Generalized linear regression|||||||0.28
72327212|NCT04971967|144177958|SUPERIORITY|||||||0.07|||||||Generalized linear regression|||||||0.07
72327213|NCT04971967|144177959|SUPERIORITY|||||||0.11|||||||Generalized linear regression|||||||0.11
72327214|NCT04723355|144178036|NON_INFERIORITY|In the sample size calculations, we assumed that the innovative 3-lead wireless water resistant Holter System would have a concordance in the diagnosis of arrhythmia compared to the conventional Holter device similar to a previous study that compared a patch to the conventional Holter device. With this assumption, a total sample of 182 participants would have 80% power to demonstrate an accuracy of at least 85% with a significance level of 2.5% (the 95% CI lower limit should be above 85%).|Accuracy|0.87|||||TWO_SIDED|95.0|0.81|0.92||||||The comparison of the two Holter monitoring devices was analyzed in terms of the accuracy of the Innovative 3-lead Wireless Water Resistant Holter System in detecting the arrhythmias compared to the Conventional Holter System as the gold standard.||0.92|0.81|
72327215|NCT04723355|144178036|OTHER||Sensitivity|0.9|||||TWO_SIDED|95.0|0.83|0.95||||||Other measures of diagnostic accuracy, including the sensitivity, specificity, positive and negative predictive values were also analyzed.||0.95|0.83|
72327216|NCT04723355|144178036|OTHER||Specificity|0.83|||||TWO_SIDED|95.0|0.72|0.9||||||Other measures of diagnostic accuracy, including the sensitivity, specificity, positive and negative predictive values were also analyzed.||0.90|0.72|
72327217|NCT04723355|144178036|OTHER||Positive predictive value|0.88|||||TWO_SIDED|95.0|0.8|0.93||||||Other measures of diagnostic accuracy, including the sensitivity, specificity, positive and negative predictive values were also analyzed.||0.93|0.80|
72419676|NCT01814748|144350452|SUPERIORITY_OR_OTHER||Difference in percent|-0.4|||||TWO_SIDED|95.0|-13.8|13.0||||||||13.0|-13.8|
72613576|NCT01970371|144756198|SUPERIORITY|The 2-sided 90% confidence interval (CI) for the difference in clinical cure percentage at the TOC visit between groups in Cohort 1 (colistin minus plazomicin) is based on the unconditional exact method.|Difference Estimate|-0.3|||||TWO_SIDED|90.0|-26.9|26.8|||1-sided Fisher's exact test|||||26.8|-26.9|
72327218|NCT04723355|144178036|OTHER||Negative predictive value|0.86|||||TWO_SIDED|95.0|0.76|0.93||||||Other measures of diagnostic accuracy, including the sensitivity, specificity, positive and negative predictive values were also analyzed.||0.93|0.76|
72327219|NCT04723355|144178036|OTHER||Cohen Kappa coefficient|0.74|||||TWO_SIDED|||||||||We also did an additional analysis to further evaluate the concordance between both Holter monitoring devices using the Cohen´s Kappa coefficient.||||
72327220|NCT04723355|144178036|OTHER||Positive likelihood ratio|5.21|||||TWO_SIDED|95.0|3.17|8.58||||||Exploratory analyses of positive and negative likelihood ratios were also conducted.||8.58|3.17|
72327221|NCT04723355|144178036|OTHER||Negative likelihood ratio|0.12|||||TWO_SIDED|95.0|0.06|0.21||||||Exploratory analyses of positive and negative likelihood ratios were also conducted.||0.21|0.06|
72327222|NCT04723355|144178037|OTHER||Accuracy|0.99|||||TWO_SIDED|95.0|0.97|1.0||||||The comparison of the two Holter monitoring devices was analyzed in terms of the accuracy of the Innovative 3-lead Wireless Water Resistant Holter System in detecting the arrhythmias compared to the Conventional Holter System as the gold standard.||1.00|0.97|
72327223|NCT04723355|144178037|OTHER||Sensitivity|1.0|||||TWO_SIDED|95.0|0.85|1.0||||||Other measures of diagnostic accuracy, including the sensitivity, specificity, positive and negative predictive values were also analyzed.||1.00|0.85|
72327224|NCT04723355|144178037|OTHER||Specificity|0.99|||||TWO_SIDED|95.0|0.97|1.0||||||Other measures of diagnostic accuracy, including the sensitivity, specificity, positive and negative predictive values were also analyzed.||1.00|0.97|
72327225|NCT04723355|144178037|OTHER||Positive predictive value|0.96|||||TWO_SIDED|95.0|0.78|1.0||||||Other measures of diagnostic accuracy, including the sensitivity, specificity, positive and negative predictive values were also analyzed.||1.00|0.78|
72327226|NCT04723355|144178037|OTHER||Negative predictive value|1.0|||||TWO_SIDED|95.0|0.98|1.0||||||Other measures of diagnostic accuracy, including the sensitivity, specificity, positive and negative predictive values were also analyzed.||1.00|0.98|
72327227|NCT04723355|144178037|OTHER||Cohen Kappa coefficient|0.97|||||TWO_SIDED|||||||||We also did an additional analysis to further evaluate the concordance between both Holter monitoring devices using the Cohen´s Kappa coefficient.||||
72327228|NCT04723355|144178037|OTHER||Positive likelihood ratio|157.0|||||TWO_SIDED|95.0|22.25|1107.61||||||Exploratory analyses of positive and negative likelihood ratios were also conducted.||1107.61|22.25|
72327229|NCT04723355|144178037|OTHER||Negative likelihood ratio|0.0|||||TWO_SIDED|95.0|0.0|0.0||||||Exploratory analyses of positive and negative likelihood ratios were also conducted.||0|0|
72327230|NCT04723355|144178038|OTHER||Accuracy|0.85|||||TWO_SIDED|95.0|0.79|0.9||||||The comparison of the two Holter monitoring devices was analyzed in terms of the accuracy of the Innovative 3-lead Wireless Water Resistant Holter System in detecting the arrhythmias compared to the Conventional Holter System as the gold standard.||0.90|0.79|
72327231|NCT04723355|144178038|OTHER||Sensitivity|0.82|||||TWO_SIDED|95.0|0.71|0.9||||||Other measures of diagnostic accuracy, including the sensitivity, specificity, positive and negative predictive values were also analyzed.||0.90|0.71|
72327232|NCT04723355|144178038|OTHER||Specificity|0.88|||||TWO_SIDED|95.0|0.8|0.93||||||Other measures of diagnostic accuracy, including the sensitivity, specificity, positive and negative predictive values were also analyzed.||0.93|0.80|
72327233|NCT04723355|144178038|OTHER||Positive predictive value|0.82|||||TWO_SIDED|95.0|0.71|0.9||||||Other measures of diagnostic accuracy, including the sensitivity, specificity, positive and negative predictive values were also analyzed.||0.90|0.71|
72419677|NCT01814748|144350453|SUPERIORITY_OR_OTHER||Difference in percent|-2.0||||||||||||||||||
72327234|NCT04723355|144178038|OTHER||Negative predictive value|0.88|||||TWO_SIDED|95.0|0.8|0.93||||||Other measures of diagnostic accuracy, including the sensitivity, specificity, positive and negative predictive values were also analyzed.||0.93|0.80|
72327235|NCT04723355|144178038|OTHER||Cohen Kappa coefficient|0.7|||||TWO_SIDED|||||||||We also did an additional analysis to further evaluate the concordance between both Holter monitoring devices using the Cohen´s Kappa coefficient.||||
72327236|NCT04723355|144178038|OTHER||Positive likelihood ratio|6.79|||||TWO_SIDED|95.0|4.03|11.43||||||Exploratory analyses of positive and negative likelihood ratios were also conducted.||11.43|4.03|
72327237|NCT04723355|144178038|OTHER||Negative likelihood ratio|0.21|||||TWO_SIDED|95.0|0.13|0.34||||||Exploratory analyses of positive and negative likelihood ratios were also conducted.||0.34|0.13|
72327238|NCT04723355|144178039|OTHER||Accuracy|0.93|||||TWO_SIDED|95.0|0.88|0.96||||||The comparison of the two Holter monitoring devices was analyzed in terms of the accuracy of the Innovative 3-lead Wireless Water Resistant Holter System in detecting the arrhythmias compared to the Conventional Holter System as the gold standard.||0.96|0.88|
72327239|NCT04723355|144178039|OTHER||Sensitivity|0.78|||||TWO_SIDED|95.0|0.56|0.93||||||Other measures of diagnostic accuracy, including the sensitivity, specificity, positive and negative predictive values were also analyzed.||0.93|0.56|
72327240|NCT04723355|144178039|OTHER||Specificity|0.95|||||TWO_SIDED|95.0|0.9|0.98||||||Other measures of diagnostic accuracy, including the sensitivity, specificity, positive and negative predictive values were also analyzed.||0.98|0.90|
72419678|NCT01814748|144350454|SUPERIORITY_OR_OTHER||Difference in least squares means|4.2||||0.685|TWO_SIDED|95.0|-16.1|24.4|||Constrained longitudinal data analysis|Terms for treatment, time, and the interaction of time by treatment, with the constraint that the mean baseline is the same for all treatment groups.||||24.4|-16.1|0.685
72419679|NCT01814748|144350455|SUPERIORITY_OR_OTHER||Difference in least squares means|-3.7||||0.586|TWO_SIDED|95.0|-17.1|9.7|||Constrained longitudinal data analysis|Terms for treatment, time, and the interaction of time by treatment, with the constraint that the mean baseline is the same for all treatment groups.||||9.7|-17.1|0.586
72419680|NCT01814748|144350456|SUPERIORITY_OR_OTHER||Between-group rate difference|-0.4|||||TWO_SIDED|95.0|-14.0|13.1|||Mietinnen and Nurminen|||||13.1|-14.0|
72327241|NCT04723355|144178039|OTHER||Positive predictive value|0.69|||||TWO_SIDED|95.0|0.48|0.86||||||Other measures of diagnostic accuracy, including the sensitivity, specificity, positive and negative predictive values were also analyzed.||0.86|0.48|
72327242|NCT04723355|144178039|OTHER||Negative predictive value|0.97|||||TWO_SIDED|95.0|0.93|0.99||||||Other measures of diagnostic accuracy, including the sensitivity, specificity, positive and negative predictive values were also analyzed.||0.99|0.93|
72327243|NCT04723355|144178039|OTHER||Cohen Kappa coefficient|0.69|||||TWO_SIDED|||||||||We also did an additional analysis to further evaluate the concordance between both Holter monitoring devices using the Cohen´s Kappa coefficient.||||
72327244|NCT04723355|144178039|OTHER||Positive likelihood ratio|15.26|||||TWO_SIDED|95.0|7.51|30.99||||||Exploratory analyses of positive and negative likelihood ratios were also conducted.||30.99|7.51|
72327245|NCT04723355|144178039|OTHER||Negative likelihood ratio|0.23|||||TWO_SIDED|95.0|0.11|0.5||||||Exploratory analyses of positive and negative likelihood ratios were also conducted.||0.50|0.11|
72327246|NCT04723355|144178040|OTHER||Accuracy|0.93|||||TWO_SIDED|95.0|0.89|0.96||||||The comparison of the two Holter monitoring devices was analyzed in terms of the accuracy of the Innovative 3-lead Wireless Water Resistant Holter System in detecting the arrhythmias compared to the Conventional Holter System as the gold standard.||0.96|0.89|
72327247|NCT04723355|144178040|OTHER||Sensitivity|0.58|||||TWO_SIDED|95.0|0.28|0.85||||||Other measures of diagnostic accuracy, including the sensitivity, specificity, positive and negative predictive values were also analyzed.||0.85|0.28|
72419681|NCT01814748|144350457|SUPERIORITY_OR_OTHER||Between-group rate difference|4.0|||||TWO_SIDED|95.0|-7.4|15.5|||Mietinnen and Nurminen|||||15.5|-7.4|
72613577|NCT01970371|144756199|SUPERIORITY|The 2-sided 90% confidence interval (CI) for the unadjusted hazard ratio between groups in Cohort 1 (colistin:plazomicin) is based on a Cox proportional hazards regression model.|Hazard Ratio (HR)|3.97|||||TWO_SIDED|90.0|1.08|14.61|||1-sided logrank test|||||14.61|1.08|
72613578|NCT01970371|144756200|SUPERIORITY|The two-sided 90% confidence interval for the difference between groups in Cohort 1 (colistin minus plazomicin) is based on the unconditional exact method.|Difference Estimate|14.1|||||TWO_SIDED|90.0|-13.0|40.3|||1-sided Fisher's exact test|||||40.3|-13|
72613579|NCT02239328|144756206|OTHER|Multilevel random coefficient models estimated the mean score of each PROMIS domain as a function of time elapsed between date of surgery and assessment (in years), and patient comorbidity. Statistical significance of estimated fixed effects were assessed by the F-test statistic for type 3 tests, p \< 0.05.|||||<|0.05|||||||ANOVA|||||||<0.05
72613580|NCT03483103|144756207|SUPERIORITY||||||<|0.0001||||||One sided P-value is calculated based on the null hypothesis ORR \<= 50.2%|Exact binomial test|||||||<.0001
72613581|NCT02313155|144756327|SUPERIORITY_OR_OTHER||Difference|-6.6|||||TWO_SIDED|95.0|-24.858|11.592|||||Seroconversion rate difference between treatment groups was obtained by subtracting the value of TAK-850 I.M. from TAK-850 S.C.|A/H1N1 Strain||11.592|-24.858|
72613582|NCT02313155|144756327|SUPERIORITY_OR_OTHER||Difference|-15.5|||||TWO_SIDED|95.0|-33.779|2.87|||||Seroconversion rate difference between treatment groups was obtained by subtracting the value of TAK-850 I.M. from TAK-850 S.C.|A/H3N2 Strain||2.870|-33.779|
72613583|NCT02313155|144756327|SUPERIORITY_OR_OTHER||Difference|-11.8|||||TWO_SIDED|95.0|-30.048|6.547|||||Seroconversion rate difference between treatment groups was obtained by subtracting the value of TAK-850 I.M. from TAK-850 S.C.|B Strain||6.547|-30.048|
72613584|NCT00689936|144756346|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.72||||6e-05|TWO_SIDED|95.0|0.61|0.85||The p-value is based on the unstratified log-rank test.|Log Rank||Based on stratified Cox proportional hazards model comparing the hazard functions associated with treatment groups.|||0.85|0.61|0.00006
72613585|NCT00689936|144756346|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.7||||1e-05|TWO_SIDED|95.0|0.6|0.82||The p-value is based on the unstratified log-rank test.|Log Rank||Based on stratified Cox proportional hazards model comparing the hazard functions associated with treatment groups.|||0.82|0.60|0.00001
72613586|NCT00689936|144756346|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.03||||0.70349|TWO_SIDED|95.0|0.89|1.2||The p-value is based on the unstratified log-rank test.|Log Rank||Based on stratified Cox proportional hazards model comparing the hazard functions associated with treatment groups.|||1.20|0.89|0.70349
72613587|NCT00689936|144756347|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.69|||<|1e-05|TWO_SIDED|95.0|0.59|0.79||The p-value is based on the unstratified log-rank test.|Log Rank||Based on a stratified Cox proportional hazards model|||0.79|0.59|<0.00001
72327248|NCT04723355|144178040|OTHER||Specificity|0.96|||||TWO_SIDED|95.0|0.92|0.98||||||Other measures of diagnostic accuracy, including the sensitivity, specificity, positive and negative predictive values were also analyzed.||0.98|0.92|
72613588|NCT00689936|144756347|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.7|||<|1e-05|TWO_SIDED|95.0|0.6|0.81||The p-value is based on the unstratified log-rank test.|Log Rank||Based on a stratified Cox proportional hazards model|||0.81|0.60|<0.00001
72613589|NCT00689936|144756347|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.99||||0.91161|TWO_SIDED|95.0|0.86|1.14||The p-value is based on the unstratified log-rank test.|Log Rank||Based on a stratified Cox proportional hazards model|||1.14|0.86|0.91161
72327249|NCT04723355|144178040|OTHER||Positive predictive value|0.5|||||TWO_SIDED|95.0|0.23|0.77||||||Other measures of diagnostic accuracy, including the sensitivity, specificity, positive and negative predictive values were also analyzed.||0.77|0.23|
72613590|NCT00689936|144756348|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.78||||0.00234|TWO_SIDED|95.0|0.67|0.92||The p-value is based on the unstratified log-rank test.|Log Rank||Based on a stratified Cox proportional hazards model|||0.92|0.67|0.00234
72613591|NCT00689936|144756348|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.02||||0.82903|TWO_SIDED|95.0|0.86|1.2||The p-value is based on the unstratified log-rank test.|Log Rank||Based on a stratified Cox proportional hazards model|||1.20|0.86|0.82903
72613592|NCT00689936|144756348|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.77||||0.00119|TWO_SIDED|95.0|0.66|0.9||The p-value is based on the unstratified log-rank test.|Log Rank||Based on a stratified Cox proportional hazards model|||0.90|0.66|0.00119
72613593|NCT00689936|144756349|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.83|||<|1e-05|TWO_SIDED|95.0|1.41|2.37|||Fisher Exact|||||2.37|1.41|<0.00001
72613594|NCT00689936|144756349|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.1||||0.53065|TWO_SIDED|95.0|0.83|1.44|||Fisher Exact|||||1.44|0.83|0.53065
72613595|NCT00689936|144756349|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.67||||0.0001|TWO_SIDED|95.0|1.29|2.15|||Fisher Exact|||||2.15|1.29|0.00010
72613596|NCT00689936|144756350|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.02|||<|1e-05|TWO_SIDED|95.0|1.53|2.68|||Fisher Exact|||||2.68|1.53|<0.00001
72613597|NCT00689936|144756350|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.14||||0.405|TWO_SIDED|95.0|0.85|1.54|||Fisher Exact|||||1.54|0.85|0.40500
72613598|NCT00689936|144756350|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.77||||4e-05|TWO_SIDED|95.0|1.35|2.32|||Fisher Exact|||||2.32|1.35|0.00004
72613599|NCT00689936|144756351|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.63|||<|1e-05|TWO_SIDED|95.0|0.51|0.76||The p-value is based on the unstratified log-rank test.|Log Rank||Based on unstratified Cox proportional hazards model.|||0.76|0.51|<0.00001
72613600|NCT00689936|144756351|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.6|||<|1e-05|TWO_SIDED|95.0|0.5|0.72||The p-value is based on the unstratified log-rank test.|Log Rank||Based on unstratified Cox proportional hazards model.|||0.72|0.50|<0.00001
72613601|NCT00689936|144756351|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.03||||0.7674|TWO_SIDED|95.0|0.86|1.23||The p-value is based on the unstratified log-rank test.|Log Rank||Based on unstratified Cox proportional hazards model.|||1.23|0.86|0.76740
72613602|NCT00689936|144756352|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.61|||<|1e-05|TWO_SIDED|95.0|0.51|0.72||The p-value is based on the unstratified log-rank test.|Log Rank||Based on a stratified Cox proportional hazards model|||0.72|0.51|<0.00001
72613603|NCT00689936|144756352|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.61|||<|1e-05|TWO_SIDED|95.0|0.52|0.72||The p-value is based on the unstratified log-rank test.|Log Rank||Based on a stratified Cox proportional hazards model|||0.72|0.52|<0.00001
72613604|NCT00689936|144756352|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.0||||0.99537|TWO_SIDED|95.0|0.85|1.17||The p-value is based on the unstratified log-rank test.|Log Rank||Based on a stratified Cox proportional hazards model|||1.17|0.85|0.99537
72613605|NCT00689936|144756353|SUPERIORITY_OR_OTHER_LEGACY||||||<|1e-05|||||||Wilcoxon (Mann-Whitney)|||||||<0.00001
72613606|NCT00689936|144756353|SUPERIORITY_OR_OTHER_LEGACY|||||||0.46672|||||||Wilcoxon (Mann-Whitney)|||||||0.46672
72327250|NCT04723355|144178040|OTHER||Negative predictive value|0.97|||||TWO_SIDED|95.0|0.93|0.99||||||Other measures of diagnostic accuracy, including the sensitivity, specificity, positive and negative predictive values were also analyzed.||0.99|0.93|
72613607|NCT00689936|144756353|SUPERIORITY_OR_OTHER_LEGACY||||||<|1e-05|||||||Wilcoxon (Mann-Whitney)|||||||<0.00001
72613608|NCT00689936|144756354|SUPERIORITY_OR_OTHER_LEGACY||||||<|1e-05|||||||Wilcoxon (Mann-Whitney)|||||||<0.00001
72613609|NCT00689936|144756354|SUPERIORITY_OR_OTHER_LEGACY|||||||0.46987|||||||Wilcoxon (Mann-Whitney)|||||||0.46987
72613610|NCT00689936|144756354|SUPERIORITY_OR_OTHER_LEGACY||||||<|1e-05|||||||Wilcoxon (Mann-Whitney)|||||||<0.00001
72613611|NCT00689936|144756355|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.77||||0.00012|TWO_SIDED|95.0|0.68|0.88||The p-value is based on the unstratified log-rank test.|Log Rank||Based on a stratified Cox proportional hazards model|||0.88|0.68|0.00012
72613612|NCT00689936|144756355|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.81||||0.00187|TWO_SIDED|95.0|0.71|0.93||The p-value is based on the unstratified log-rank test.|Log Rank||Based on a stratified Cox proportional hazards model|||0.93|0.71|0.00187
72613613|NCT00689936|144756355|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.95||||0.45973|TWO_SIDED|95.0|0.84|1.08||The p-value is based on the unstratified log-rank test.|Log Rank||Based on a stratified Cox proportional hazards model|||1.08|0.84|0.45973
72613614|NCT00689936|144756356|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.76||||2e-05|TWO_SIDED|95.0|0.67|0.86||The p-value is based on the unstratified log-rank test.|Log Rank||Based on a stratified Cox proportional hazards model|||0.86|0.67|0.00002
72613615|NCT00689936|144756356|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.81||||0.00126|TWO_SIDED|95.0|0.72|0.92||The p-value is based on the unstratified log-rank test.|Log Rank||Based on a stratified Cox proportional hazards model|||0.92|0.72|0.00126
72613616|NCT00689936|144756356|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.93||||0.27704|TWO_SIDED|95.0|0.83|1.06||The p-value is based on the unstratified log-rank test.|Log Rank||Based on a stratified Cox proportional hazards model|||1.06|0.83|0.27704
72613617|NCT00689936|144756357|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.66|||<|1e-05|TWO_SIDED|95.0|0.56|0.78||The p-value is based on the unstratified log-rank test.|Log Rank||Based on a stratified Cox proportional hazards model|||0.78|0.56|<0.00001
72613618|NCT00689936|144756357|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.74||||0.00067|TWO_SIDED|95.0|0.63|0.88||The p-value is based on the unstratified log-rank test.|Log Rank||Based on a stratified Cox proportional hazards model|||0.88|0.63|0.00067
72613619|NCT00689936|144756357|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.88||||0.12333|TWO_SIDED|95.0|0.75|1.03||The p-value is based on the unstratified log-rank test.|Log Rank||Based on a stratified Cox proportional hazards model|||1.03|0.75|0.12333
72613620|NCT00689936|144756358|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.63|||<|1e-05|TWO_SIDED|95.0|0.54|0.73||The p-value is based on the unstratified log-rank test.|Log Rank||Based on unstratified Cox proportional hazards model.|||.73|0.54|<0.00001
72613621|NCT00689936|144756358|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.71||||1e-05|TWO_SIDED|95.0|0.61|0.83||The p-value is based on the unstratified log-rank test.|Log Rank||Based on unstratified Cox proportional hazards model.|||0.83|0.61|0.00001
72613622|NCT00689936|144756358|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.87||||0.05821|TWO_SIDED|95.0|0.76|1.0||The p-value is based on the unstratified log-rank test.|Log Rank||Based on unstratified Cox proportional hazards model.|||1.00|0.76|0.05821
72613623|NCT00689936|144756359|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.02||||0.93824|TWO_SIDED|95.0|0.75|1.38|||Fisher Exact|||||1.38|0.75|0.93824
72613624|NCT00689936|144756359|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.76||||0.08836|TWO_SIDED|95.0|0.56|1.03|||Fisher Exact|||||1.03|0.56|0.08836
72613625|NCT00689936|144756359|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.34||||0.04974|TWO_SIDED|95.0|1.01|1.79|||Fisher Exact|||||1.79|1.01|0.04974
72613626|NCT00689936|144756360|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.68||||0.02134|TWO_SIDED|95.0|1.08|2.59|||Fisher Exact|||||2.59|1.08|0.02134
72613627|NCT00689936|144756360|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.01||||1|TWO_SIDED|95.0|0.64|1.59|||Fisher Exact|||||1.59|0.64|1.00000
72613628|NCT00689936|144756360|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.65||||0.02374|TWO_SIDED|95.0|1.08|2.53|||Fisher Exact|||||2.53|1.08|0.02374
72613629|NCT00689936|144756361|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.7||||0.11152|TWO_SIDED|95.0|0.91|3.21|||Fisher Exact|||||3.21|0.91|0.11152
72613630|NCT00689936|144756361|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.93||||0.86336|TWO_SIDED|95.0|0.47|1.83|||Fisher Exact|||||1.83|0.47|0.86336
72613631|NCT00689936|144756361|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.84||||0.07321|TWO_SIDED|95.0|0.96|3.55|||Fisher Exact|||||3.55|0.96|0.07321
72613632|NCT00689936|144756362|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.62||||0.00043|TWO_SIDED|95.0|1.55|4.45|||Fisher Exact|||||4.45|1.55|0.00043
72613633|NCT00689936|144756362|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.38||||0.31274|TWO_SIDED|95.0|0.78|2.43|||Fisher Exact|||||2.43|0.78|0.31274
72613634|NCT00689936|144756362|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.9||||0.01936|TWO_SIDED|95.0|1.13|3.19|||Fisher Exact|||||3.19|1.13|0.01936
72327251|NCT04723355|144178040|OTHER||Cohen Kappa coefficient|0.77|||||TWO_SIDED|||||||||We also did an additional analysis to further evaluate the concordance between both Holter monitoring devices using the Cohen´s Kappa coefficient.||||
72327252|NCT04723355|144178040|OTHER||Positive likelihood ratio|13.92|||||TWO_SIDED|95.0|5.84|33.17||||||Exploratory analyses of positive and negative likelihood ratios were also conducted.||33.17|5.84|
72327253|NCT04723355|144178040|OTHER||Negative likelihood ratio|0.43|||||TWO_SIDED|95.0|0.22|0.85||||||Exploratory analyses of positive and negative likelihood ratios were also conducted.||0.85|0.22|
72327254|NCT04723355|144178041|OTHER||Accuracy|0.98|||||TWO_SIDED|95.0|0.95|1.0||||||The comparison of the two Holter monitoring devices was analyzed in terms of the accuracy of the Innovative 3-lead Wireless Water Resistant Holter System in detecting the arrhythmias compared to the Conventional Holter System as the gold standard.||1.00|0.95|
72327255|NCT04723355|144178041|OTHER||Sensitivity|0.75|||||TWO_SIDED|95.0|0.19|0.99||||||Other measures of diagnostic accuracy, including the sensitivity, specificity, positive and negative predictive values were also analyzed.||0.99|0.19|
72327256|NCT04723355|144178041|OTHER||Specificity|0.99|||||TWO_SIDED|95.0|0.96|1.0||||||Other measures of diagnostic accuracy, including the sensitivity, specificity, positive and negative predictive values were also analyzed.||1.00|0.96|
72327257|NCT04723355|144178041|OTHER||Positive predictive value|0.6|||||TWO_SIDED|95.0|0.15|0.95||||||Other measures of diagnostic accuracy, including the sensitivity, specificity, positive and negative predictive values were also analyzed.||0.95|0.15|
72419682|NCT01972529|144350463|SUPERIORITY||Difference of proportion vs placebo|42.6|||<|0.0001|TWO_SIDED|95.0|27.2|58.1|||Cochran-Mantel-Haenszel|Stratified by the risk of bleeding associated with the elective procedure within each baseline platelet count cohort.|Difference of proportion versus (vs) placebo = proportion of Responders for avatrombopag - proportion of Responders for placebo; 95% CI is calculated based on normal approximation.|The null hypothesis was that the proportion of participants not requiring a platelet transfusion or any rescue procedure for bleeding after randomization and up to 7 days following a scheduled procedure was the same between the 60 mg avatrombopag and matched placebo treatment groups.||58.1|27.2|<0.0001
72419683|NCT01972529|144350463|SUPERIORITY||Difference of proportion vs placebo|49.9|||<|0.0001|TWO_SIDED|95.0|31.6|68.2|||Cochran-Mantel-Haenszel|Stratified by the risk of bleeding associated with the elective procedure within each baseline platelet count cohort.|Difference of proportion vs placebo = proportion of Responders for avatrombopag - proportion of Responders for placebo; 95% CI is calculated based on normal approximation.|The null hypothesis was that the proportion of participants not requiring a platelet transfusion or any rescue procedure for bleeding after randomization and up to 7 days following a scheduled procedure was the same between the avatrombopag and placebo treatment groups.||68.2|31.6|<0.0001
72419684|NCT01972529|144350464|SUPERIORITY||Difference of proportion vs placebo|64.7|||<|0.0001|TWO_SIDED|95.0|53.6|75.8|||Cochran-Mantel-Haenszel|P-value is stratified by the risk of bleeding associated with the elective procedure within each baseline platelet count cohort.|Difference of proportion vs placebo = proportion of responders for avatrombopag - proportion of responders for placebo; 95% CI is calculated based on normal approximation.|The null hypothesis was that the proportion of participants not requiring a platelet transfusion or any rescue procedure for bleeding after randomization and up to 7 days following a scheduled procedure was the same between the avatrombopag and placebo treatment groups||75.8|53.6|<0.0001
72419685|NCT01972529|144350464|SUPERIORITY||Difference of percentage vs placebo|67.5|||<|0.0001|TWO_SIDED|95.0|51.6|83.4|||Cochran-Mantel-Haenszel|P-value is stratified by the risk of bleeding associated with the elective procedure within each baseline platelet count cohort.|Difference of proportion vs placebo = proportion of responders for avatrombopag - proportion of responders for placebo; 95% CI is calculated based on normal approximation.|The null hypothesis was that the proportion of participants not requiring a platelet transfusion or any rescue procedure for bleeding after randomization and up to 7 days following a scheduled procedure was the same between the avatrombopag and placebo treatment groups||83.4|51.6|<0.0001
72419686|NCT01972529|144350465|SUPERIORITY||Difference in change of platelet count|27.5|||<|0.0001|TWO_SIDED|95.0|22.5|32.5|||Wilcoxon (Mann-Whitney)|P-value is based on Wilcoxon rank sum test for each avatrombopag treatment group vs placebo within each baseline platelet count cohort.|Difference in change from baseline of platelet count for avatrombopag vs placebo within each baseline platelet count cohort is based on Hodges-Lehmann estimation; 95% confidence interval is the asymptotic (Moses) CI.|||32.5|22.5|<0.0001
72419687|NCT01972529|144350465|SUPERIORITY||Difference in change of platelet count|33.0|||<|0.0001|TWO_SIDED|95.0|25.5|41.5|||Wilcoxon (Mann-Whitney)|P-value is based on Wilcoxon rank sum test for each avatrombopag treatment group vs placebo within each baseline platelet count cohort.|Difference in change from baseline of platelet count for avatrombopag vs placebo within each baseline platelet count cohort is based on Hodges-Lehmann estimation; 95% confidence interval is the asymptotic (Moses) CI.|||41.5|25.5|<0.0001
72419688|NCT02274857|144350468|SUPERIORITY|||||||0.2179|||||||Chi-squared|||||||0.2179
72613635|NCT00689936|144756363|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.13||||0.82128|TWO_SIDED|95.0|0.46|2.8|||Fisher Exact|||||2.80|0.46|0.82128
72613636|NCT00689936|144756363|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.46||||0.11041|TWO_SIDED|95.0|0.19|1.14|||Fisher Exact|||||1.14|0.19|0.11041
72419689|NCT02274857|144350469|SUPERIORITY|||||||0.2782|||||||Chi-squared|||||||0.2782
72419690|NCT02274857|144350470|SUPERIORITY|||||||0.7266|||||||Chi-squared|||||||0.7266
72613637|NCT00689936|144756363|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.44||||0.07302|TWO_SIDED|95.0|1.01|5.91|||Fisher Exact|||||5.91|1.01|0.07302
72419691|NCT02274857|144350471|SUPERIORITY|||||||0.3522|||||||Chi-squared|||||||0.3522
72613638|NCT06001866|144756433|SUPERIORITY||||||<|0.0001|||||||LSD test|||||||<0.0001
72327258|NCT04723355|144178041|OTHER||Negative predictive value|0.99|||||TWO_SIDED|95.0|0.97|1.0||||||Other measures of diagnostic accuracy, including the sensitivity, specificity, positive and negative predictive values were also analyzed.||1.00|0.97|
72419692|NCT00939874|144350475|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||t-test, 2 sided|||||||<0.0001
72419693|NCT00330174|144350477|SUPERIORITY_OR_OTHER|||||||0.64|TWO_SIDED|95.0|||||Mixed Models Analysis|||Drinking outcomes were analyzed using multiple linear regression, controlling for site and baseline drinking level. Drinking and psychiatric symptoms assessed over time were examined using repeated measures (intercept only) mixed linear models (PROC MIXED in SAS). Analyses were performed using SAS statistical software (version 9.2; SAS Institute, Inc., Cary, NC). All tests were two-tailed and p-values less than 0.05 were considered statistically significant.||||0.64
72613639|NCT06001866|144756433|SUPERIORITY||||||<|1e-05|||||||LSD test|||||||<0.00001
72327259|NCT04723355|144178041|OTHER||Cohen Kappa coefficient|0.66|||||TWO_SIDED|||||||||We also did an additional analysis to further evaluate the concordance between both Holter monitoring devices using the Cohen´s Kappa coefficient.||||
72613640|NCT06001866|144756434|SUPERIORITY||||||<|1e-05|||||||LSD test|||||||<0.00001
72613641|NCT06001866|144756434|SUPERIORITY||||||<|1e-05|||||||LSD test|||||||<0.00001
72613642|NCT06001866|144756435|SUPERIORITY||||||=|0.78|||||||LSD test|||||||=0.78
72613643|NCT06001866|144756435|SUPERIORITY||||||<|1e-05|||||||LSD test|||||||<.00001
72613644|NCT06001866|144756436|SUPERIORITY||||||=|1|||||||LSD test|||||||=1.00
72613645|NCT06001866|144756436|SUPERIORITY||||||<|1e-05|||||||LSD test|||||||<0.00001
72613646|NCT06001866|144756437|SUPERIORITY||||||=|0.75|||||||LSD test|||||||=0.75
72613647|NCT06001866|144756437|SUPERIORITY||||||<|0.01|||||||LSD test|||||||<0.01
72613648|NCT06001866|144756438|SUPERIORITY||||||<|1e-05|||||||LSD test|||||||<0.00001
72613649|NCT06001866|144756438|SUPERIORITY||||||=|0.62|||||||LSD test|||||||=0.62
72613650|NCT06001866|144756439|SUPERIORITY||||||=|0.16|||||||LSD test|||||||=0.16
72613651|NCT06001866|144756439|SUPERIORITY||||||=|0.33|||||||LSD test|||||||=0.33
72613652|NCT06001866|144756440|SUPERIORITY||||||=|0.54|||||||t-test, 2 sided|||||||=.54
72613653|NCT06001866|144756441|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<.001
72327260|NCT04723355|144178041|OTHER||Positive likelihood ratio|65.63|||||TWO_SIDED|95.0|14.8|291.07||||||Exploratory analyses of positive and negative likelihood ratios were also conducted.||291.07|14.80|
72327261|NCT04723355|144178041|OTHER||Negative likelihood ratio|0.25|||||TWO_SIDED|95.0|0.05|1.38||||||Exploratory analyses of positive and negative likelihood ratios were also conducted.||1.38|0.05|
72327262|NCT04723355|144178042|OTHER||Accuracy|0.98|||||TWO_SIDED|95.0|0.94|0.99||||||The comparison of the two Holter monitoring devices was analyzed in terms of the accuracy of the Innovative 3-lead Wireless Water Resistant Holter System in detecting the arrhythmias compared to the Conventional Holter System as the gold standard.||0.99|0.94|
72327263|NCT04723355|144178042|OTHER||Sensitivity|0.64|||||TWO_SIDED|95.0|0.31|0.89||||||Other measures of diagnostic accuracy, including the sensitivity, specificity, positive and negative predictive values were also analyzed.||0.89|0.31|
72327264|NCT04723355|144178042|OTHER||Specificity|1.0|||||TWO_SIDED|95.0|0.98|1.0||||||Other measures of diagnostic accuracy, including the sensitivity, specificity, positive and negative predictive values were also analyzed.||1.00|0.98|
72327265|NCT04723355|144178042|OTHER||Positive predictive value|1.0|||||TWO_SIDED|95.0|0.59|1.0||||||Other measures of diagnostic accuracy, including the sensitivity, specificity, positive and negative predictive values were also analyzed.||1.00|0.59|
72327266|NCT04723355|144178042|OTHER||Negative predictive value|0.98|||||TWO_SIDED|95.0|0.94|0.99||||||Other measures of diagnostic accuracy, including the sensitivity, specificity, positive and negative predictive values were also analyzed.||0.99|0.94|
72327267|NCT04723355|144178042|OTHER||Cohen Kappa coefficient|0.77|||||TWO_SIDED|||||||||We also did an additional analysis to further evaluate the concordance between both Holter monitoring devices using the Cohen´s Kappa coefficient.||||
72327268|NCT04723355|144178042|OTHER|||||||||||||||||Exploratory analyses of positive and negative likelihood ratios were also conducted.|The positive likelihood ratio could not be calculated due to the value of zero in the denominator|||
72419694|NCT01032733|144350481|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.06|STANDARD_DEVIATION|0.5|<|0.05|ONE_SIDED|95.0|||||ANCOVA|||This trial represented a pilot study, which was designed to demonstrate the feasibility, acceptability, and efficacy of the intervention; therefore, a power analysis was not conducted. The statistical analyses consisted of descriptive and intent-to-treat (ITT) modeling procedures.||||<0.05
72327269|NCT04723355|144178042|OTHER||Negative likelihood ratio|0.36|||||TWO_SIDED|95.0|0.17|0.79||||||Exploratory analyses of positive and negative likelihood ratios were also conducted.||0.79|0.17|
72327270|NCT04723355|144178044|OTHER||Mean Difference (Final Values)|-0.94|||||TWO_SIDED|95.0|-6.2|4.31||||||The quantitative secondary outcomes were analyzed using Bland-Altman graphs as well as the Lin´s concordance correlation coefficient (CCC).||4.31|-6.20|
72419695|NCT01032733|144350482|SUPERIORITY_OR_OTHER||Mean Difference (Net)|5.0|STANDARD_DEVIATION|5.0|<|0.05|TWO_SIDED|95.0|||||ANCOVA|||||||<0.05
72327271|NCT04723355|144178044|OTHER||Lin´s concordance correlation coeficient|0.97|||||TWO_SIDED|95.0|0.96|0.98||||||The quantitative secondary outcomes were analyzed using Bland-Altman graphs as well as the Lin´s concordance correlation coefficient (CCC).||0.98|0.96|
72327272|NCT04723355|144178045|OTHER||Mean Difference (Final Values)|-2.71|||||TWO_SIDED|95.0|-17.09|11.67||||||The quantitative secondary outcomes were analyzed using Bland-Altman graphs as well as the Lin´s concordance correlation coefficient (CCC).||11.67|-17.09|
72327273|NCT04723355|144178045|OTHER||Lin´s concordance correlation coeficient|0.95|||||TWO_SIDED|95.0|0.93|0.96||||||The quantitative secondary outcomes were analyzed using Bland-Altman graphs as well as the Lin´s concordance correlation coefficient (CCC).||0.96|0.93|
72327274|NCT04723355|144178046|OTHER||Mean Difference (Final Values)|0.39|||||TWO_SIDED|95.0|-5.43|6.22||||||The quantitative secondary outcomes were analyzed using Bland-Altman graphs as well as the Lin´s concordance correlation coefficient (CCC).||6.22|-5.43|
72327275|NCT04723355|144178046|OTHER||Lin´s concordance correlation coeficient|0.95|||||TWO_SIDED|95.0|0.93|0.96||||||The quantitative secondary outcomes were analyzed using Bland-Altman graphs as well as the Lin´s concordance correlation coefficient (CCC).||0.96|0.93|
72327276|NCT04723355|144178047|OTHER||Mean Difference (Final Values)|-6.37|||||TWO_SIDED|95.0|-1391.46|1378.72||||||The quantitative secondary outcomes were analyzed using Bland-Altman graphs as well as the Lin´s concordance correlation coefficient (CCC).||1378.72|-1391.46|
72327277|NCT04723355|144178047|OTHER||Lin´s concordance correlation coeficient|0.95|||||TWO_SIDED|95.0|0.94|0.96||||||The quantitative secondary outcomes were analyzed using Bland-Altman graphs as well as the Lin´s concordance correlation coefficient (CCC).||0.96|0.94|
72327278|NCT04723355|144178048|OTHER||Mean Difference (Final Values)|11.04|||||TWO_SIDED|95.0|-2089.58|2111.65||||||The quantitative secondary outcomes were analyzed using Bland-Altman graphs as well as the Lin´s concordance correlation coefficient (CCC).||2111.65|-2089.58|
72327279|NCT04723355|144178048|OTHER||Lin´s concordance correlation coeficient|0.92|||||TWO_SIDED|95.0|0.89|0.94||||||The quantitative secondary outcomes were analyzed using Bland-Altman graphs as well as the Lin´s concordance correlation coefficient (CCC).||0.94|0.89|
72327280|NCT04723355|144178049|OTHER||Mean Difference (Final Values)|-0.12|||||TWO_SIDED|95.0|-5.45|5.2||||||The quantitative secondary outcomes were analyzed using Bland-Altman graphs as well as the Lin´s concordance correlation coefficient (CCC).||5.20|-5.45|
72327281|NCT04723355|144178049|OTHER||Lin´s concordance correlation coeficient|0.93|||||TWO_SIDED|95.0|0.91|0.94||||||The quantitative secondary outcomes were analyzed using Bland-Altman graphs as well as the Lin´s concordance correlation coefficient (CCC).||0.94|0.91|
72327282|NCT04723355|144178050|OTHER||Mean Difference (Final Values)|-0.66|||||TWO_SIDED|95.0|-13.38|12.07||||||The quantitative secondary outcomes were analyzed using Bland-Altman graphs as well as the Lin´s concordance correlation coefficient (CCC).||12.07|-13.38|
72327283|NCT04723355|144178050|OTHER||Lin´s concordance correlation coeficient|0.987|||||TWO_SIDED|95.0|0.98|0.99||||||The quantitative secondary outcomes were analyzed using Bland-Altman graphs as well as the Lin´s concordance correlation coefficient (CCC).||0.99|0.98|
72419696|NCT01032733|144350483|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.0|STANDARD_DEVIATION|2.0|<|0.05|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.05
72419697|NCT01032733|144350484|SUPERIORITY_OR_OTHER||Mean Difference (Net)|5.0|STANDARD_DEVIATION|15.0|<|0.05|TWO_SIDED|95.0|||||ANCOVA|||||||<0.05
72419698|NCT01032733|144350485|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.0|STANDARD_DEVIATION|1.0|<|0.05|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.05
72613654|NCT02903914|144756449|OTHER|||||||0.0731|||||||ANOVA|1-factor ANOVA of log-transformed, dose-normalized data (factor = dose)||||||0.0731
72613655|NCT02903914|144756449|OTHER||pairwise geometric mean ratio (GMR)|0.933|||||TWO_SIDED|90.0|0.784|1.11||||||||1.110|0.784|
72613656|NCT02903914|144756449|OTHER||pairwise GMR|1.074|||||TWO_SIDED|90.0|0.908|1.271||||||||1.271|0.908|
72613657|NCT02903914|144756449|OTHER||pairwise GMR|1.23|||||TWO_SIDED|90.0|1.034|1.463||||||||1.463|1.034|
72613658|NCT02903914|144756450|OTHER|||||||0.1496|||||||Kruskal-Wallis|1-factor ANOVA of log-transformed, dose-normalized data (factor = dose)||||||0.1496
72613659|NCT02903914|144756451|OTHER|||||||0.2867|||||||ANOVA|1-factor ANOVA of log-transformed, dose-normalized data (factor = dose)||||||0.2867
72613660|NCT02903914|144756451|OTHER||pairwise GMR|1.007|||||TWO_SIDED|90.0|0.825|1.23||||||||1.230|0.825|
72613661|NCT02903914|144756451|OTHER||pairwise GMR|1.081|||||TWO_SIDED|90.0|0.892|1.311||||||||1.311|0.892|
72613662|NCT02903914|144756451|OTHER||pairwise GMR|1.234|||||TWO_SIDED|90.0|1.011|1.507||||||||1.507|1.011|
72613663|NCT02903914|144756452|OTHER|||||||0.6167|||||||ANOVA|1-factor ANOVA of log-transformed, dose-normalized data (factor = dose)||||||0.6167
72613664|NCT02903914|144756452|OTHER||pairwise GMR|1.014|||||TWO_SIDED|90.0|0.82|1.255||||||||1.255|0.820|
72613665|NCT02903914|144756452|OTHER||pairwise GMR|1.043|||||TWO_SIDED|90.0|0.849|1.281||||||||1.281|0.849|
72613666|NCT02903914|144756452|OTHER||pairwise GMR|1.17|||||TWO_SIDED|90.0|0.945|1.447||||||||1.447|0.945|
72613667|NCT02903914|144756456|OTHER|||||||0.0745|||||||ANOVA|1-factor ANOVA of log-transformed, dose-normalized data (factor = dose)||||||0.0745
72613668|NCT02903914|144756456|OTHER||pairwise GMR|1.127|||||TWO_SIDED|90.0|0.947|1.341||||||||1.341|0.947|
72613669|NCT02903914|144756456|OTHER||pairwise GMR|0.991|||||TWO_SIDED|90.0|0.833|1.18||||||||1.180|0.833|
72613670|NCT02903914|144756456|OTHER||pairwise GMR|1.258|||||TWO_SIDED|90.0|1.064|1.486||||||||1.486|1.064|
72613671|NCT02903914|144756457|OTHER|||||||0.0518|||||||Kruskal-Wallis|||||||0.0518
72613672|NCT02903914|144756458|OTHER|||||||0.1723|||||||ANOVA|1-factor ANOVA of log-transformed, dose-normalized data (factor = dose)||||||0.1723
72613673|NCT02903914|144756458|OTHER||pairwise GMR|1.156|||||TWO_SIDED|90.0|0.941|1.42||||||||1.420|0.941|
72613674|NCT02903914|144756458|OTHER||pairwise GMR|0.976|||||TWO_SIDED|90.0|0.794|1.198||||||||1.198|0.794|
72613675|NCT02903914|144756458|OTHER||pairwise GMR|1.233|||||TWO_SIDED|90.0|1.012|1.503||||||||1.503|1.012|
72613676|NCT02903914|144756459|OTHER|||||||0.1705|||||||ANOVA|1-factor ANOVA of log-transformed, dose-normalized data (factor = dose)||||||0.1705
72613677|NCT02903914|144756459|OTHER||pairwise GMR|1.083|||||TWO_SIDED|90.0|0.863|1.359||||||||1.359|0.863|
72613678|NCT02903914|144756459|OTHER||pairwise GMR|0.902|||||TWO_SIDED|90.0|0.719|1.132||||||||1.132|0.719|
72613679|NCT02903914|144756459|OTHER||pairwise GMR|1.212|||||TWO_SIDED|90.0|0.945|1.554||||||||1.554|0.945|
72613680|NCT02903914|144756463|OTHER||pairwise GMR|1.057||||0.7702|TWO_SIDED|90.0|0.753|1.483|||ANOVA|1-factor ANOVA of log-transformed, dose-normalized data (factor = food effect)||Fed versus Fasted||1.483|0.753|0.7702
72613681|NCT02903914|144756463|OTHER||pairwise GMR|1.012||||0.9384|TWO_SIDED|90.0|0.762|1.346|||ANOVA|1-factor ANOVA of log-transformed, dose-normalized data (factor = food effect)||Fed versus Fasted||1.346|0.762|0.9384
72613682|NCT02903914|144756463|OTHER||pairwise GMR|1.07||||0.6733|TWO_SIDED|90.0|0.809|1.415|||ANOVA|1-factor ANOVA of log-transformed, dose-normalized data (factor = food effect)||Fed versus Fasted||1.415|0.809|0.6733
72613683|NCT02903914|144756463|OTHER||pairwise GMR|1.238||||0.3456|TWO_SIDED|90.0|0.83|1.847|||ANOVA|1-factor ANOVA of log-transformed, dose-normalized data (factor = food effect)||Fed versus Fasted||1.847|0.830|0.3456
72613684|NCT02903914|144756464|OTHER|||||||0.0441|||||||Wilcoxon (Mann-Whitney)|||Fed versus Fasted||||0.0441
72613685|NCT02903914|144756464|OTHER|||||||0.4092|||||||Wilcoxon (Mann-Whitney)|||Fed versus Fasted||||0.4092
72613686|NCT02903914|144756464|OTHER|||||||0.7748|||||||Wilcoxon (Mann-Whitney)|||Fed versus Fasted||||0.7748
72613687|NCT02903914|144756464|OTHER|||||||0.1948|||||||Wilcoxon (Mann-Whitney)|||Fed versus Fasted||||0.1948
72613688|NCT02903914|144756465|OTHER||pairwise GMR|0.92||||0.705|TWO_SIDED|90.0|0.62|1.363|||ANOVA|1-factor ANOVA of log-transformed, dose-normalized data (factor = food effect)||Fed versus Fasted||1.363|0.620|0.7050
72613689|NCT02903914|144756465|OTHER||pairwise GMR|0.929||||0.703|TWO_SIDED|90.0|0.658|1.31|||ANOVA|1-factor ANOVA of log-transformed, dose-normalized data (factor = food effect)||Fed versus Fasted||1.310|0.658|0.7030
72613690|NCT02903914|144756465|OTHER||pairwise GMR|0.999||||0.9952|TWO_SIDED|90.0|0.725|1.377|||ANOVA|1-factor ANOVA of log-transformed, dose-normalized data (factor = food effect)||Fed versus Fasted||1.377|0.725|0.9952
72613691|NCT02903914|144756465|OTHER||pairwise GMR|0.742||||0.4012|TWO_SIDED|90.0|0.394|1.397|||ANOVA|1-factor ANOVA of log-transformed, dose-normalized data (factor = food effect)||Fed versus Fasted||1.397|0.394|0.4012
72613692|NCT02903914|144756466|OTHER||pairwise GMR|0.992||||0.9623|TWO_SIDED|90.0|0.729|1.349|||ANOVA|1-factor ANOVA of log-transformed, dose-normalized data (factor = formulation)||Tablet (test) versus Capsule (reference)||1.349|0.729|0.9623
72613693|NCT02903914|144756467|OTHER|||||||0.754|||||||Wilcoxon (Mann-Whitney)|||Tablet (test) versus Capsule (reference)||||0.7540
72613694|NCT02903914|144756468|OTHER||pairwise GMR|0.951||||0.7514|TWO_SIDED|90.0|0.718|1.261|||ANOVA|1-factor ANOVA of log-transformed, dose-normalized data (factor = dose)||Tablet (test) versus Capsule (reference)||1.261|0.718|0.7514
72613695|NCT02903914|144756469|OTHER||pairwise GMR|0.954||||0.7707|TWO_SIDED|90.0|0.712|1.277|||ANOVA|1-factor ANOVA of log-transformed, dose-normalized data (factor = formulation)||Tablet (test) versus Capsule (reference)||1.277|0.712|0.7707
72613696|NCT02296125|144756700|SUPERIORITY||Hazard Ratio (HR)|0.46|||<|0.0001|TWO_SIDED|95.0|0.37|0.57|||Log Rank|||||0.57|0.37|<0.0001
72613697|NCT02296125|144756700|OTHER|The china cohort was not powered for superiority|Hazard Ratio (HR)|0.56||||0.0065|TWO_SIDED|95.0|0.37|0.85|||Log Rank|||||0.85|0.37|0.0065
72613698|NCT02296125|144756702|SUPERIORITY||Odds Ratio (OR)|1.51||||0.036|TWO_SIDED|95.0|1.03|2.22|||Regression, Logistic|||||2.22|1.03|0.036
72613699|NCT02296125|144756702|OTHER|The china cohort was not powered for superiority|Odds Ratio (OR)|1.31||||0.485|TWO_SIDED|95.0|0.61|2.84|||Regression, Logistic|||||2.84|0.61|0.485
72613700|NCT02296125|144756703|OTHER|The china cohort was not powered for superiority|Mean Difference (Final Values)|2.48||||0.0133|TWO_SIDED|95.0|1.21|5.09|||Regression, Linear|||||5.09|1.21|0.0133
72613701|NCT02296125|144756703|SUPERIORITY||Mean Difference (Final Values)|2.27|||<|0.0001|TWO_SIDED|95.0|1.68|3.08|||Regression, Linear|||||3.08|1.68|<0.0001
72613702|NCT02296125|144756704|SUPERIORITY||Odds Ratio (OR)|2.78||||0.011|TWO_SIDED|95.0|1.25|6.78|||Regression, Logistic||An odds ratio \> 1 favours osimertinib|||6.78|1.25|0.0110
72613703|NCT02296125|144756704|OTHER|The china cohort was not powered for superiority|Odds Ratio (OR)|1.67||||0.5772|TWO_SIDED|95.0|0.27|12.98|||Regression, Logistic||An odds ratio \>1 favours osimertinib|||12.98|0.27|0.5772
72613704|NCT02296125|144756705|SUPERIORITY||Mean Difference (Final Values)|-6.8||||0.0025|TWO_SIDED|95.0|-11.205|-2.403|||Regression, Linear|||||-2.403|-11.205|0.0025
72613705|NCT02296125|144756705|OTHER|The china cohort was not powered for superiority|Mean Difference (Final Values)|-6.59||||0.1348|TWO_SIDED|95.0|-15.246|2.072|||Regression, Linear|||||2.072|-15.246|0.1348
72613706|NCT02296125|144756706|SUPERIORITY||Hazard Ratio (HR)|0.799||||0.0462|TWO_SIDED|95.0|0.6409|0.9963|||Log Rank|||||0.9963|0.6409|0.0462
72419699|NCT00409682|144350486|SUPERIORITY_OR_OTHER||Mean Difference (Net)|10.29||||0.075|TWO_SIDED|95.0|-3.14|23.71||There is no adjustment for multiple comparison on the primary outcome measure.|Cochran-Mantel-Haenszel||Difference is between adalimumab High-dose and adalimumab Low-dose group.|The point estimates for the number of subjects who achieved PCDAI clinical remission in each treatment group and the difference in number between the groups were provided. The P value and 95% confidence intervals (CIs) for the difference were provided. The P value is from the CMH test adjusted for infliximab use and response status at Week 4. The primary analysis was performed for the intent-to-treat (ITT) using the non-responder (NRI) imputation method.||23.71|-3.14|0.075
72613707|NCT02296125|144756706|OTHER|The china cohort was not powered for superiority|Hazard Ratio (HR)|0.848||||0.4416|TWO_SIDED|95.0|0.5568|1.291|||Log Rank|||||1.2910|0.5568|0.4416
72613708|NCT00157755|144756726|SUPERIORITY_OR_OTHER|||||||0.215||||||A significance level of 0.05 was applied to the test. No adjustments were made for multiple comparisons.|Wilcoxon Signed Rank Test|||"Null hypothesis: There was no change in the frequency of weekly vomiting episodes from when stimulation was turned OFF to when stimulation was turned ON, µ = 0;~Alternative hypothesis: There was a change in frequency of weekly vomiting episodes from when stimulation was turned OFF to when stimulation was turned ON, µ ≠ 0"||||0.215
72613709|NCT00157755|144756726|SUPERIORITY_OR_OTHER|||||||1||||||A significance level of 0.05 was applied to the test. No adjustments were made for multiple comparisons.|Wilcoxon Signed Rank Test|||"Null hypothesis: There was no change in the frequency of weekly vomiting episodes from when stimulation was turned OFF to when stimulation was turned ON, µ = 0;~Alternative hypothesis: There was a change in frequency of weekly vomiting episodes from when stimulation was turned OFF to when stimulation was turned ON, µ ≠ 0"||||1.0
72327284|NCT04723355|144178051|OTHER||Mean Difference (Final Values)|-0.09|||||TWO_SIDED|95.0|-1.75|1.56||||||The quantitative secondary outcomes were analyzed using Bland-Altman graphs as well as the Lin´s concordance correlation coefficient (CCC).||1.56|-1.75|
72613710|NCT00157755|144756727|SUPERIORITY_OR_OTHER|||||||0.903||||||A significance level of 0.05 was applied to the test. No adjustments were made for multiple comparisons.|Wilcoxon Signed Rank Test|||"Null hypothesis: There was no change in total symptom score from when stimulation was turned OFF to when stimulation was turned ON, µ = 0;~Alternative hypothesis: There was a change in total symptom score from when stimulation was turned OFF to when stimulation was turned ON, µ ≠ 0"||||0.903
72613711|NCT00157755|144756727|SUPERIORITY_OR_OTHER|||||||0.932||95.0||||A significance level of 0.05 was applied to the test. No adjustments were made for multiple comparisons.|Wilcoxon Signed Rank Test|||"Null hypothesis: There was no change in total symptom score from when stimulation was turned OFF to when stimulation was turned ON, µ = 0;~Alternative hypothesis: There was a change in total symptom score from when stimulation was turned OFF to when stimulation was turned ON, µ ≠ 0"||||0.932
72613712|NCT00157755|144756728|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||A significance level of 0.05 was applied to the test. No adjustments were made for multiple comparisons.|Wilcoxon Signed Rank Test|||"Null hypothesis: There was no change from baseline in the long-term frequency of weekly vomiting episodes, µ = 0;~Alternative hypothesis: There was a change from baseline in the long-term frequency of weekly vomiting episodes, µ ≠ 0"||||<0.001
72613713|NCT00157755|144756728|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||A significance level of 0.05 was applied to the test. No adjustments were made for multiple comparisons.|Wilcoxon Signed Rank Test|||"Null hypothesis: There was no change from baseline in the long-term frequency of weekly vomiting episodes, µ = 0;~Alternative hypothesis: There was a change from baseline in the long-term frequency of weekly vomiting episodes, µ ≠ 0"||||<0.001
72613714|NCT00157755|144756729|SUPERIORITY_OR_OTHER|||||||0.014||||||A one-sided significance level of 0.025 was applied to the test. No adjustments were made for multiple comparisons.|binomial, 1 sided|||"Null hypothesis: The percentage of responders was less than or equal to 50%;~Alternative hypothesis: The percentage of responders was greater than 50%"||||0.014
72613715|NCT00157755|144756729|SUPERIORITY_OR_OTHER||||||<|0.001||||||A one-sided significance level of 0.025 was applied to the test. No adjustments were made for multiple comparisons.|binomial, 1 sided|||"Null hypothesis: The percentage of responders was less than or equal to 50%;~Alternative hypothesis: The percentage of responders was greater than 50%"||||<0.001
72613716|NCT00157755|144756730|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||A significance level of 0.05 was applied to the test. No adjustments were made for multiple comparisons.|Paired t-test|||"Null hypothesis: There was no change in total symptom score from baseline to 12 months, µ = 0;~Alternative hypothesis: There was a change in total symptom score from baseline to 12 months, µ ≠ 0"||||<0.001
72613717|NCT00157755|144756730|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||A significance level of 0.05 was applied to the test. No adjustments were made for multiple comparisons.|Paired t-test|||"Null hypothesis: There was no change in total symptom score from baseline to 12 months, µ = 0;~Alternative hypothesis: There was a change in total symptom score from baseline to 12 months, µ ≠ 0"||||<0.001
72613718|NCT00157755|144756731|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||A significance level of 0.05 was applied to the test. No adjustments were made for multiple comparisons.|Paired t-test|||"Null hypothesis: There was no change in PCS score from baseline to 12 months, µ = 0;~Alternative hypothesis: There was a change in PCS score from baseline to 12 months, µ ≠ 0"||||<0.001
72327285|NCT04723355|144178051|OTHER||Lin´s concordance correlation coeficient|0.9976|||||TWO_SIDED|95.0|0.997|0.998||||||The quantitative secondary outcomes were analyzed using Bland-Altman graphs as well as the Lin´s concordance correlation coefficient (CCC).||0.998|0.997|
72613719|NCT00157755|144756731|SUPERIORITY_OR_OTHER|||||||0.043||95.0||||A significance level of 0.05 was applied to the test. No adjustments were made for multiple comparisons.|Paired t-test|||"Null hypothesis: There was no change in PCS score from baseline to 12 months, µ = 0;~Alternative hypothesis: There was a change in PCS score from baseline to 12 months, µ ≠ 0"||||0.043
72613720|NCT00157755|144756732|SUPERIORITY_OR_OTHER|||||||0.009||95.0||||A significance level of 0.05 was applied to the test. No adjustments were made for multiple comparisons.|Paired t-test|||"Null hypothesis: There was no change in MCS score from baseline to 12 months, µ = 0;~Alternative hypothesis: There was a change in MCS score from baseline to 12 months, µ ≠ 0"||||0.009
72613721|NCT00157755|144756732|SUPERIORITY_OR_OTHER|||||||0.001||95.0||||A significance level of 0.05 was applied to the test. No adjustments were made for multiple comparisons.|Paired t-test|||"Null hypothesis: There was no change in MCS score from baseline to 12 months, µ = 0;~Alternative hypothesis: There was a change in MCS score from baseline to 12 months, µ ≠ 0"||||0.001
72327286|NCT04723355|144178052|SUPERIORITY||chi-squared test statistic|23.529|||<|0.0001|TWO_SIDED||||||Chi-squared|||||||<0.0001
72327287|NCT01109108|144178053|OTHER||Risk Ratio (RR)|1.0|||<|0.05|TWO_SIDED|95.0|||||Chi-squared|||||||<0.05
72327288|NCT01516632|144178069|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.62|||||TWO_SIDED|95.0|0.82|3.21||||||||3.21|.82|
72327289|NCT01516632|144178070|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.55|||||TWO_SIDED|95.0|1.22|5.3||||||||5.30|1.22|
72613722|NCT00157755|144756733|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||A significance level of 0.05 was applied to the test. No adjustments were made for multiple comparisons.|Wilcoxon Signed Rank Test|||"Null hypothesis: There was no change in 2-hour gastric emptying from baseline to 12 months, µ = 0;~Alternative hypothesis: There was a change in 2-hour gastric emptying from baseline to 12 months, µ ≠ 0"||||<0.001
72613723|NCT00157755|144756733|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||A significance level of 0.05 was applied to the test. No adjustments were made for multiple comparisons.|Wilcoxon Signed Rank Test|||"Null hypothesis: There was no change in 2-hour gastric emptying from baseline to 12 months, µ = 0;~Alternative hypothesis: There was a change in 2-hour gastric emptying from baseline to 12 months, µ ≠ 0"||||<0.001
72613724|NCT00157755|144756734|SUPERIORITY_OR_OTHER|||||||0.016||95.0||||A significance level of 0.05 was applied to the test. No adjustments were made for multiple comparisons.|Wilcoxon Signed Rank Test|||"Null hypothesis: There was no change in 4-hour gastric emptying from baseline to 12 months, µ = 0;~Alternative hypothesis: There was a change in 4-hour gastric emptying from baseline to 12 months, µ ≠ 0"||||0.016
72613725|NCT00157755|144756734|SUPERIORITY_OR_OTHER|||||||0.236||95.0||||A significance level of 0.05 was applied to the test. No adjustments were made for multiple comparisons.|Wilcoxon Signed Rank Test|||"Null hypothesis: There was no change in 4-hour gastric emptying from baseline to 12 months, µ = 0;~Alternative hypothesis: There was a change in 4-hour gastric emptying from baseline to 12 months, µ ≠ 0"||||0.236
72613726|NCT05845619|144756752|SUPERIORITY|There was no power calculation because this was a pilot study.|Odds Ratio (OR)|1.21||||0.33|TWO_SIDED|95.0|0.83|1.76|||Regression, Logistic||Numerator: pilot; denominator: prospective controls|In this pilot study, we hypothesized that pilot participants would have a reduced risk of viremia 6 months after the intervention compared to controls.||1.76|0.83|0.33
72613727|NCT05845619|144756752|SUPERIORITY|No power calculation, pilot study.|Odds Ratio (OR)|1.25||||0.41|TWO_SIDED|95.0|0.73|2.14|||Regression, Logistic|||||2.14|0.73|0.41
72613728|NCT05168800|144756784|SUPERIORITY|||||||0.99||||||To achieve a group-wise 95% confidence for the primary outcome, each of the three tests were evaluated with acceptance based on a 98.4% confidence interval, or greater than 2.15 standard deviations of the mean for the superiority analyses.|Groupwise binomial comparison|||||||0.99
72613729|NCT05168800|144756784|SUPERIORITY|||||||0.98||||||To achieve a group-wise 95% confidence for the primary outcome, each of the three tests were evaluated with acceptance based on a 98.4% confidence interval, or greater than 2.15 standard deviations of the mean for the superiority analyses.|Groupwise binomial comparison|||||||0.98
72613730|NCT05168800|144756784|EQUIVALENCE|A sample size of 1800 LTCWs (600 per arm) was identified to provide 80% power to detect an 8% difference in the rate of individuals reporting vaccine confidence between arms with 95% confidence. This sample size was sufficient to retain 80% power to detect a 10% difference after 40% attrition. Per study design, the equivalence margin is +/- 10% with anticipated attrition using the binomial confidence interval.||||||0.85||||||To achieve a group-wise 95% confidence for the primary outcome, each of the three tests were evaluated with acceptance based on a 98.4% confidence interval, or +/- 2.45 standard deviations of the mean for the equivalency test.|Groupwise binomial comparison|||||||0.85
72613731|NCT05168800|144756785|SUPERIORITY|||||||0.93|||||||Fisher Exact|||||||0.93
72327290|NCT01516632|144178071|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.33|||||TWO_SIDED|95.0|1.48|7.45||||||||7.45|1.48|
72327291|NCT00348946|144178077|SUPERIORITY|BOT Visual-motor control||||||0.005|||||||ANCOVA|||||||0.005
72327292|NCT00348946|144178077|SUPERIORITY|||||||0.17|||||||ANCOVA|||BOT upper limb speed||||0.17
72327293|NCT00348946|144178077|SUPERIORITY|||||||0.17|||||||ANCOVA|||BOT strength||||0.17
72327294|NCT00348946|144178077|SUPERIORITY|||||||0.06|||||||ANCOVA|||Hand dynamometer||||0.06
72327295|NCT00348946|144178077|SUPERIORITY|||||||0.87|||||||ANCOVA|||PANESS||||0.87
72327296|NCT00348946|144178078|SUPERIORITY|||||||0.44|||||||ANCOVA|||DAS: General concept ability||||0.44
72327297|NCT00348946|144178078|SUPERIORITY|||||||0.57|||||||ANCOVA|||DAS: Verbal Cluster||||0.57
72613732|NCT05168800|144756785|SUPERIORITY|||||||0.9|||||||Fisher Exact|||||||0.90
72613733|NCT05168800|144756785|EQUIVALENCE|The study was not powered for secondary outcome analyses.||||||0.83|||||||Fisher Exact|||||||0.83
72613734|NCT05168800|144756786|SUPERIORITY|||||||0.22|||||||Fisher Exact|||||||0.22
72613735|NCT05168800|144756786|SUPERIORITY|||||||0.43|||||||Fisher Exact|||||||0.43
72613736|NCT05168800|144756786|EQUIVALENCE|The study was not powered for secondary outcome analyses.||||||0.61|||||||Fisher Exact|||||||0.61
72613737|NCT05168800|144756787|SUPERIORITY|||||||0.65|||||||Fisher Exact|||||||0.65
72327298|NCT00348946|144178078|SUPERIORITY|||||||0.55|||||||ANCOVA|||DAS: Nonverbal Cluster||||0.55
72327299|NCT00348946|144178078|SUPERIORITY|||||||0.65|||||||ANCOVA|||DAS: Spatial Cluster||||0.65
72327300|NCT00348946|144178079|SUPERIORITY|||||||0.23|||||||ANCOVA|||Digit Span backward||||0.23
72327301|NCT00348946|144178079|SUPERIORITY|||||||0.36|||||||ANCOVA|||Phonetic fluency||||0.36
72327302|NCT00348946|144178079|SUPERIORITY|||||||0.37|||||||ANCOVA|||Semantic fluency||||0.37
72327303|NCT00348946|144178079|SUPERIORITY|||||||0.41|||||||ANCOVA|||CPT: omissions||||0.41
72327304|NCT00348946|144178079|SUPERIORITY|||||||0.73|||||||ANCOVA|||CPT: commissions||||0.73
72327305|NCT00348946|144178079|SUPERIORITY|||||||0.4|||||||ANCOVA|||CPT: hit reaction time||||0.40
72327306|NCT00348946|144178079|SUPERIORITY|||||||0.95|||||||ANCOVA|||CPT: variability||||0.95
72327307|NCT00348946|144178079|SUPERIORITY|||||||0.78|||||||ANCOVA|||CPT: preservations||||0.78
72327308|NCT00348946|144178080|SUPERIORITY|||||||0.16|||||||ANCOVA|||CBCL: Behavior total||||0.16
72327309|NCT00348946|144178080|SUPERIORITY|||||||0.1|||||||ANCOVA|||CBCL: Internalizing total||||0.10
72327310|NCT00348946|144178080|SUPERIORITY|||||||0.24|||||||ANCOVA|||CBCL: externalizing total||||0.24
72327311|NCT00348946|144178080|SUPERIORITY|||||||0.5|||||||ANCOVA|||CDI: Total||||0.50
72327312|NCT00348946|144178081|SUPERIORITY|||||||0.15|||||||ANCOVA|||||||0.15
72613738|NCT05168800|144756787|SUPERIORITY|||||||0.34|||||||Fisher Exact|||||||0.34
72327313|NCT02820844|144178118|OTHER||Mean Difference (Net)|-2.16|||<|0.001|TWO_SIDED|95.0|-3.14|-1.18||Analysis was performed using mixed-model for repeated measures (MMRM) with treatment, site, visit, treatment-by-visit interaction, Baseline value, Baseline-by-visit interaction as fixed effects.|MMRM||Mean difference (Net) at Week 12 has been presented.|||-1.18|-3.14|<0.001
72613739|NCT05168800|144756787|EQUIVALENCE|The study was not powered for secondary outcome analyses.||||||0.48|||||||Fisher Exact|||||||0.48
72613740|NCT05168800|144756788|SUPERIORITY|||||||0.88|||||||Adjusted Wald test|||||||0.88
72613741|NCT05168800|144756788|SUPERIORITY|||||||0.97|||||||Adjusted Wald test|||||||0.97
72613742|NCT05168800|144756788|EQUIVALENCE|The study was not powered for secondary outcome analyses.||||||0.48|||||||Adjusted Wald test|||||||0.48
72613743|NCT05168800|144756789|SUPERIORITY|||||||0.95|||||||Adjusted Wald test|||||||0.95
72613744|NCT05168800|144756789|SUPERIORITY|||||||0.98|||||||Adjusted Wald test|||||||0.98
72613745|NCT05168800|144756789|EQUIVALENCE|The study was not powered for secondary outcome analyses.||||||0.66|||||||Adjusted Wald test|||||||0.66
72613746|NCT05168800|144756790|SUPERIORITY|||||||0.08|||||||Fisher Exact|||||||0.08
72613747|NCT05168800|144756790|SUPERIORITY|||||||0.64|||||||Fisher Exact|||||||0.64
72613748|NCT05168800|144756790|EQUIVALENCE|The study was not powered for secondary outcome analyses.||||||0.09|||||||Fisher Exact|||||||0.09
72613749|NCT05168800|144756791|SUPERIORITY|||||||0.13|||||||Fisher Exact|||||||0.13
72613750|NCT05168800|144756791|SUPERIORITY|||||||0.73|||||||Fisher Exact|||||||0.73
72613751|NCT05168800|144756791|EQUIVALENCE|The study was not powered for secondary outcome analyses.||||||0.1|||||||Fisher Exact|||||||0.10
72613752|NCT05168800|144756792|SUPERIORITY|||||||0.37|||||||Fisher Exact|||||||0.37
72613753|NCT05168800|144756792|SUPERIORITY|||||||0.45|||||||Fisher Exact|||||||0.45
72613754|NCT05168800|144756792|EQUIVALENCE|The study was not powered for secondary outcome analyses.||||||0.88|||||||Fisher Exact|||||||0.88
72613755|NCT05168800|144756793|SUPERIORITY|||||||0.92|||||||Adjusted Wald test|||||||0.92
72613756|NCT05168800|144756793|SUPERIORITY|||||||0.97|||||||Adjusted Wald test|||||||0.97
72613757|NCT05168800|144756793|EQUIVALENCE|The study was not powered for secondary outcome analyses.||||||0.83|||||||Adjusted Wald test|||||||0.83
72613758|NCT05168800|144756794|SUPERIORITY|||||||0.88|||||||Adjusted Wald test|||||||0.88
72613759|NCT05168800|144756794|SUPERIORITY|||||||0.49|||||||Adjusted Wald test|||||||0.49
72613760|NCT05168800|144756794|EQUIVALENCE|The study was not powered for secondary outcome analyses.||||||0.23|||||||Adjusted Wald test|||||||0.23
72613761|NCT05168800|144756795|SUPERIORITY|||||||0.9|||||||Adjusted Wald test|||||||0.90
72613762|NCT05168800|144756795|SUPERIORITY|||||||0.94|||||||Adjusted Wald test|||||||0.94
72613763|NCT05168800|144756795|EQUIVALENCE|The study was not powered for secondary outcome analyses.||||||0.86|||||||Adjusted Wald test|||||||0.86
72613764|NCT05168800|144756796|SUPERIORITY|||||||1|||||||Two-sample z test|||||||1.00
72613765|NCT05168800|144756796|SUPERIORITY|||||||1|||||||Two-sample z test|||||||1.0
72613766|NCT05168800|144756796|EQUIVALENCE|The study was not powered for secondary outcome analyses.||||||0.49|||||||Two-sample z test|||||||0.49
72613767|NCT05168800|144756797|SUPERIORITY|||||||0.88|||||||Two-sample z test|||||||0.88
72613768|NCT05168800|144756797|SUPERIORITY|||||||1|||||||Two-sample z test|||||||1.00
72613769|NCT05168800|144756797|EQUIVALENCE|The study was not powered for secondary outcome analyses.||||||0.02|||||||Two-sample z test|||||||0.02
72613770|NCT05168800|144756798|SUPERIORITY|||||||0.82|||||||Two-sample z test|||||||0.82
72613771|NCT05168800|144756798|SUPERIORITY|||||||0.97|||||||Two-sample z test|||||||0.97
72613772|NCT05168800|144756798|EQUIVALENCE|The study was not powered for secondary outcome analyses.||||||0.18|||||||Two-sample z test|||||||0.18
72327314|NCT02820844|144178119|OTHER||Mean Difference (Net)|29.69|||<|0.001|TWO_SIDED|95.0|18.47|40.91||Analysis performed using MMRM, with treatment, site, visit, Baseline urinary urgency incontinence (UUI) episodes over 3 day diary (\<=9 or \>=10), treatment-by-visit interaction, Baseline value, Baseline-by-visit interaction as fixed effects.|MMRM||Mean difference (Net) at Week 12 has been presented.|||40.91|18.47|<0.001
72327315|NCT02820844|144178174|OTHER||Hazard Ratio (HR)|0.45|||<|0.001|TWO_SIDED|95.0|0.34|0.6||P-value is from log-rank test stratified by Baseline urinary urgency incontinence episodes over 3 day diary (\<=9 versus \>=10).|Log Rank||Hazard ratio and 95% Confidence Interval (CI) are estimated using the Cox proportional hazard model with treatment and Baseline urinary urgency incontinence episodes over 3 day diary (\<=9 versus \>=10) as fixed effect.|||0.60|0.34|<0.001
72613773|NCT04556097|144756806|SUPERIORITY||Rate Ratio|0.61|STANDARD_ERROR_OF_MEAN|0.35||0.05|TWO_SIDED|95.0|0.31|1.2|||Difference in differences|Difference in differences model with a negative binomial distribution and log link that provides rate ratio estimate of the relative difference.|The rate ratio is estimated for intervention patients as compared to controls.|||1.20|0.31|0.05
72613774|NCT04556097|144756807|SUPERIORITY||Mean Difference (Net)|-2.7|STANDARD_ERROR_OF_MEAN|1.95||0.05|TWO_SIDED|95.0|-6.53|1.12|||Difference in differences|Difference in differences model with a Gaussian distribution and identity link that provides linear estimate of the relative point difference.||||1.12|-6.53|0.05
72613775|NCT02516241|144756808|SUPERIORITY||Hazard Ratio (HR)|0.85||||0.0751|TWO_SIDED|98.66|0.688|1.063||The 2-sided p-value was calculated using a stratified log-rank test adjusting for PD-L1 status, visceral metastases and cisplatin eligibility status.|Log Rank||The HR and confidence interval (CI) were calculated using a stratified Cox proportional hazards model, adjusting for PD-L1 status, visceral metastases and cisplatin eligibility status with ties handled by the Breslow approach.|||1.063|0.688|0.0751
72613776|NCT02516241|144756809|SUPERIORITY||Hazard Ratio (HR)|0.89||||0.3039|TWO_SIDED|96.99|0.695|1.139||The 2-sided p-value was calculated using a stratified log-rank test adjusting for visceral metastases and cisplatin eligibility status.|Log Rank||The HR and confidence interval (CI) were calculated using a stratified Cox proportional hazards model, adjusting for visceral metastases and cisplatin eligibility status with ties handled by the Breslow approach.|||1.139|0.695|0.3039
72613777|NCT02516241|144756810|SUPERIORITY||Hazard Ratio (HR)|0.99||||0.8637|TWO_SIDED|95.0|0.83|1.169||The 2-sided p-value was calculated using a stratified log-rank test adjusting for PD-L1 status, visceral metastases and cisplatin eligibility status.|Log Rank||The HR and confidence interval (CI) were calculated using a stratified Cox proportional hazards model, adjusting for PD-L1 status, visceral metastases and cisplatin eligibility status with ties handled by the Breslow approach.|||1.169|0.830|0.8637
72613778|NCT02516241|144756811|SUPERIORITY||Hazard Ratio (HR)|0.74||||0.0091|TWO_SIDED|95.0|0.589|0.928||The 2-sided p-value was calculated using a stratified log-rank test adjusting for visceral metastases and cisplatin eligibility status.|Log Rank||The HR and confidence interval (CI) were calculated using a stratified Cox proportional hazards model, adjusting for visceral metastases and cisplatin eligibility status with ties handled by the Breslow approach.|||0.928|0.589|0.0091
72613779|NCT02516241|144756812|SUPERIORITY||Hazard Ratio (HR)|1.04||||0.7599|TWO_SIDED|95.0|0.799|1.359||The 2-sided p-value was calculated using a stratified log-rank test adjusting for visceral metastases and cisplatin eligibility status.|Log Rank||The HR and confidence interval (CI) were calculated using a stratified Cox proportional hazards model, adjusting for visceral metastases and cisplatin eligibility status with ties handled by the Breslow approach.|||1.359|0.799|0.7599
72613780|NCT02516241|144756812|SUPERIORITY||Hazard Ratio (HR)|0.9||||0.4424|TWO_SIDED|95.0|0.692|1.175||The 2-sided p-value was calculated using a stratified log-rank test adjusting for visceral metastases and cisplatin eligibility status.|Log Rank||The HR and confidence interval (CI) were calculated using a stratified Cox proportional hazards model, adjusting for visceral metastases and cisplatin eligibility status with ties handled by the Breslow approach.|monotherapy as reference.||1.175|0.692|0.4424
72613781|NCT02516241|144756816|SUPERIORITY||Hazard Ratio (HR)|1.1||||0.2579|TWO_SIDED|95.0|0.931|1.304||The 2-sided p-value was calculated using a stratified log-rank test adjusting for PD-L1 status, visceral metastases and cisplatin eligibility status.|Log Rank||The HR and confidence interval (CI) were calculated using a stratified Cox proportional hazards model, adjusting for PD-L1 status, visceral metastases and cisplatin eligibility status with ties handled by the Breslow approach.|||1.304|0.931|0.2579
72613782|NCT02516241|144756816|SUPERIORITY||Hazard Ratio (HR)|1.33||||0.0008|TWO_SIDED|95.0|1.124|1.567||The 2-sided p-value was calculated using a stratified log-rank test adjusting for PD-L1 status, visceral metastases and cisplatin eligibility status.|Log Rank||The HR and confidence interval (CI) were calculated using a stratified Cox proportional hazards model, adjusting for PD-L1 status, visceral metastases and cisplatin eligibility status with ties handled by the Breslow approach.|||1.567|1.124|0.0008
72613783|NCT02516241|144756817|SUPERIORITY||Hazard Ratio (HR)|0.88||||0.2395|TWO_SIDED|95.0|0.705|1.091||The 2-sided p-value was calculated using a stratified log-rank test adjusting for visceral metastases and cisplatin eligibility status.|Log Rank||The HR and confidence interval (CI) were calculated using a stratified Cox proportional hazards model, adjusting for visceral metastases and cisplatin eligibility status with ties handled by the Breslow approach.|||1.091|0.705|0.2395
72613784|NCT02516241|144756817|SUPERIORITY||Hazard Ratio (HR)|1.14||||0.2431|TWO_SIDED|95.0|0.917|1.406||The 2-sided p-value was calculated using a stratified log-rank test adjusting for visceral metastases and cisplatin eligibility status.|Log Rank||The HR and confidence interval (CI) were calculated using a stratified Cox proportional hazards model, adjusting for visceral metastases and cisplatin eligibility status with ties handled by the Breslow approach.|||1.406|0.917|0.2431
72613785|NCT02516241|144756818|SUPERIORITY||Hazard Ratio (HR)|1.53||||0.0014|TWO_SIDED|95.0|1.177|1.99||The 2-sided p-value was calculated using a stratified log-rank test adjusting for visceral metastases and cisplatin eligibility status.|Log Rank||The HR and confidence interval (CI) were calculated using a stratified Cox proportional hazards model, adjusting for visceral metastases and cisplatin eligibility status with ties handled by the Breslow approach.|||1.990|1.177|0.0014
72327316|NCT02820844|144178175|OTHER||Hazard Ratio (HR)|0.5|||<|0.001|TWO_SIDED|95.0|0.38|0.66||P-value is from log-rank test stratified by Baseline urinary urgency incontinence episodes over 3 day diary (\<=9 versus \>=10)|Log Rank||Hazard ratio and 95% CI are estimated using the Cox proportional hazard model with treatment and Baseline urinary urgency incontinence episodes over 3 day diary (\<=9 versus \>=10) as fixed effect.|||0.66|0.38|<0.001
72327317|NCT02266147|144178255|OTHER|MTD was not observed because no DLTs occurred at the maximum dose tested. Because this is a safety endpoint, a statistical analysis was not conducted.||||||||||||||||MTD was not observed because no DLTs occurred at the maximum dose tested. Because this is a safety endpoint, a statistical analysis was not conducted.|MTD was not observed because no DLTs occurred at the maximum dose tested. Because this is a safety endpoint, a statistical analysis was not conducted.|||
72327318|NCT01896687|144178261|SUPERIORITY_OR_OTHER||||||<|0.001||||||"The worst pain and interference scores as dependent variables, and time (baseline, 1-, and 3 week follow up visit), group (Calmare or Sham), and group by time interaction terms as the independent variable."|ANOVA|||||||<0.001
72327319|NCT02831855|144178293|NON_INFERIORITY|Non-inferiority (NI) of Tofacitinib 11 mg + Methotrexate Placebo to Tofacitinib 11 mg + continued Methotrexate was concluded if the upper bound of 95% 2-sided confidence interval (CI) for difference between the 2 arms (Tofacitinib 11 mg + Methotrexate Placebo reporting arm - Tofacitinib 11 mg + continued Methotrexate arm) was lower than 0.6.|Least Square (LS) Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|0.09||0.0005|TWO_SIDED|95.0|0.12|0.48||The p-value is one-sided for the test against the NI margin of 0.6.|MMRM|||Linear mixed-effect model of repeated measures (MMRM) was used that included the fixed effects of treatment, visit, treatment-by-visit interaction, prior use of a biological disease-modifying anti-rheumatic drug (bDMARD), and baseline DAS28-4 (ESR) value as a covariate.||0.48|0.12|0.0005
72327320|NCT02831855|144178294|SUPERIORITY||LS Mean Difference|0.22|STANDARD_ERROR_OF_MEAN|0.1|||TWO_SIDED|95.0|0.03|0.41||||||Linear MMRM was used that included the fixed effects of treatment, visit, treatment-by-visit interaction, prior use of a bDMARD and baseline DAS28-4 (ESR) value as a covariate.||0.41|0.03|
72327321|NCT02831855|144178295|SUPERIORITY||LS Mean Difference|0.26|STANDARD_ERROR_OF_MEAN|0.09|||TWO_SIDED|95.0|0.08|0.43||||||Change at Week 36: Linear MMRM was used that included the fixed effects of treatment, visit, treatment -by-visit interaction, prior use of a bDMARD and baseline DAS28-4 (CRP) value as a covariate.||0.43|0.08|
72327322|NCT02831855|144178295|SUPERIORITY||LS Mean Difference|0.28|STANDARD_ERROR_OF_MEAN|0.09|||TWO_SIDED|95.0|0.11|0.45||||||Change at Week 48: Linear MMRM was used that included the fixed effects of treatment, visit, treatment -by-visit interaction, prior use of a bDMARD and baseline DAS28-4 (CRP) value as a covariate.||0.45|0.11|
72327323|NCT02831855|144178296|SUPERIORITY||LS Mean Difference|1.74|STANDARD_ERROR_OF_MEAN|0.68|||TWO_SIDED|95.0|0.4|3.07||||||Change at Week 36: Linear MMRM was used that included the fixed effects of treatment, visit, treatment-by-visit interaction, prior use of a bDMARD and baseline CDAI value as a covariate.||3.07|0.40|
72327324|NCT02831855|144178296|SUPERIORITY||LS Mean Difference|2.13|STANDARD_ERROR_OF_MEAN|0.66|||TWO_SIDED|95.0|0.83|3.43||||||Change at Week 48: Linear MMRM was used that included the fixed effects of treatment, visit, treatment-by-visit interaction, prior use of a bDMARD and baseline CDAI value as a covariate.||3.43|0.83|
72327325|NCT02831855|144178297|SUPERIORITY||LS Mean Difference|1.95|STANDARD_ERROR_OF_MEAN|0.72|||TWO_SIDED|95.0|0.53|3.37||||||Change at Week 36: Linear MMRM was used that included the fixed effects of treatment, visit, treatment-by-visit interaction, prior use of a bDMARD and baseline SDAI value as a covariate.||3.37|0.53|
72327326|NCT02831855|144178297|SUPERIORITY||LS Mean Difference|2.23|STANDARD_ERROR_OF_MEAN|0.69|||TWO_SIDED|95.0|0.86|3.59||||||Change at Week 48: Linear MMRM was used that included the fixed effects of treatment, visit, treatment-by-visit interaction, prior use of a bDMARD and baseline SDAI value as a covariate.||3.59|0.86|
72327327|NCT02831855|144178298|SUPERIORITY||Difference in percentage of participants|-5.69|||||TWO_SIDED|95.0|-14.15|2.76||||||Week 36||2.76|-14.15|
72327328|NCT02831855|144178298|SUPERIORITY||Difference in percentage of participants|-4.54|||||TWO_SIDED|95.0|-13.04|3.94||||||Week 48||3.94|-13.04|
72327329|NCT02831855|144178299|SUPERIORITY||Difference in percentage of participants|-5.14|||||TWO_SIDED|95.0|-13.07|2.77||||||Week 36||2.77|-13.07|
72327330|NCT02831855|144178299|SUPERIORITY||Difference in percentage of participants|-8.52|||||TWO_SIDED|95.0|-16.28|-0.76||||||Week 48||-0.76|-16.28|
72327331|NCT02831855|144178300|SUPERIORITY||Difference in percentage of participants|-7.39|||||TWO_SIDED|95.0|-15.17|0.38||||||Week 36||0.38|-15.17|
72327332|NCT02831855|144178300|SUPERIORITY||Difference in percentage of participants|-11.91|||||TWO_SIDED|95.0|-19.56|-4.26||||||Week 48||-4.26|-19.56|
72613786|NCT02516241|144756818|SUPERIORITY||Hazard Ratio (HR)|0.94||||0.6236|TWO_SIDED|95.0|0.729|1.209||The 2-sided p-value was calculated using a stratified log-rank test adjusting for visceral metastases and cisplatin eligibility status.|Log Rank||The HR and confidence interval (CI) were calculated using a stratified Cox proportional hazards model, adjusting for visceral metastases and cisplatin eligibility status with ties handled by the Breslow approach.|monotherapy as reference.||1.209|0.729|0.6236
72613787|NCT02516241|144756822|SUPERIORITY||Hazard Ratio (HR)|0.83||||0.0477|TWO_SIDED|95.0|0.683|0.998||The 2-sided p-value was calculated using a stratified log-rank test adjusting for PD-L1 status, visceral metastases and cisplatin eligibility status.|Log Rank||The HR and confidence interval (CI) were calculated using a stratified Cox proportional hazards model, adjusting for PD-L1 status, visceral metastases and cisplatin eligibility status with ties handled by the Breslow approach.|||0.998|0.683|0.0477
72613788|NCT02516241|144756822|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.7885|TWO_SIDED|95.0|0.809|1.175||The 2-sided p-value was calculated using a stratified log-rank test adjusting for PD-L1 status, visceral metastases and cisplatin eligibility status.|Log Rank||The HR and confidence interval (CI) were calculated using a stratified Cox proportional hazards model, adjusting for PD-L1 status, visceral metastases and cisplatin eligibility status with ties handled by the Breslow approach.|||1.175|0.809|0.7885
72613789|NCT02516241|144756823|SUPERIORITY||Hazard Ratio (HR)|0.7||||0.0053|TWO_SIDED|95.0|0.549|0.901||The 2-sided p-value was calculated using a stratified log-rank test adjusting for visceral metastases and cisplatin eligibility status.|Log Rank||The HR and confidence interval (CI) were calculated using a stratified Cox proportional hazards model, adjusting for visceral metastases and cisplatin eligibility status with ties handled by the Breslow approach.|||0.901|0.549|0.0053
72327333|NCT02831855|144178301|SUPERIORITY||Difference in percentage of participants|-7.02|||||TWO_SIDED|95.0|-14.81|0.77||||||Week 36||0.77|-14.81|
72327334|NCT02831855|144178301|SUPERIORITY||Difference in percentage of participants|-10.02|||||TWO_SIDED|95.0|-17.68|-2.37||||||Week 48||-2.37|-17.68|
72419700|NCT00409682|144350487|SUPERIORITY_OR_OTHER||Mean Difference (Net)|10.18||||0.1|TWO_SIDED|95.0|-2.62|22.97||The hierarchical stepwise closed testing procedure was implemented to control the overall significance level at 0.05 in the ITT population.|Cochran-Mantel-Haenszel||A significance test for any individual major secondary efficacy endpoint in the hierarchy was to be inferential only if the hypothesis tests of all preceding major secondary efficacy endpoints were statistically significant at 0.050.|The point estimates for the number of subjects who achieved PCDAI clinical remission in each treatment group and the difference in number between the groups were provided. The P value and 95% CIs for the difference were provided. The analysis was performed for the intent-to-treat (ITT) population using the non-responder imputation (NRI) method.||22.97|-2.62|0.100
72613790|NCT02516241|144756823|SUPERIORITY||Hazard Ratio (HR)|0.83||||0.1336|TWO_SIDED|95.0|0.651|1.059||The 2-sided p-value was calculated using a stratified log-rank test adjusting for visceral metastases and cisplatin eligibility status.|Log Rank||The HR and confidence interval (CI) were calculated using a stratified Cox proportional hazards model, adjusting for visceral metastases and cisplatin eligibility status with ties handled by the Breslow approach.|||1.059|0.651|0.1336
72613791|NCT02516241|144756824|SUPERIORITY||Hazard Ratio (HR)|1.04||||0.8148|TWO_SIDED|95.0|0.772|1.391||The 2-sided p-value was calculated using a stratified log-rank test adjusting for visceral metastases and cisplatin eligibility status.|Log Rank||The HR and confidence interval (CI) were calculated using a stratified Cox proportional hazards model, adjusting for visceral metastases and cisplatin eligibility status with ties handled by the Breslow approach.|||1.391|0.772|0.8148
72613792|NCT02516241|144756824|SUPERIORITY||Hazard Ratio (HR)|0.85||||0.2684|TWO_SIDED|95.0|0.636|1.134||The 2-sided p-value was calculated using a stratified log-rank test adjusting for visceral metastases and cisplatin eligibility status.|Log Rank||The HR and confidence interval (CI) were calculated using a stratified Cox proportional hazards model, adjusting for visceral metastases and cisplatin eligibility status with ties handled by the Breslow approach.|monotherapy as reference.||1.134|0.636|0.2684
72613793|NCT02516241|144756825|SUPERIORITY||Odds Ratio (OR)|0.58||||0.0005|TWO_SIDED|95.0|0.422|0.788||P-value was based on twice the change in log-likelihood resulting from logistic regression model, adjusting for PD-L1 status, visceral metastases and cisplatin eligibility status.|Regression, Logistic||The OR and confidence interval (CI) were calculated using logistic regression, adjusting for PD-L1 status, visceral metastases and cisplatin eligibility status.|||0.788|0.422|0.0005
72613794|NCT02516241|144756825|SUPERIORITY||Odds Ratio (OR)|0.35|||<|0.0001|TWO_SIDED|95.0|0.253|0.485||P-value was based on twice the change in log-likelihood resulting from logistic regression model, adjusting for PD-L1 status, visceral metastases and cisplatin eligibility status.|Regression, Logistic||The OR and confidence interval (CI) were calculated using logistic regression, adjusting for PD-L1 status, visceral metastases and cisplatin eligibility status.|||0.485|0.253|<0.0001
72613795|NCT02516241|144756826|SUPERIORITY||Odds Ratio (OR)|0.94||||0.7708|TWO_SIDED|95.0|0.639|1.394||P-value was based on twice the change in log-likelihood resulting from logistic regression model, adjusting for visceral metastases and cisplatin eligibility status.|Regression, Logistic||The OR and confidence interval (CI) were calculated using logistic regression, adjusting for visceral metastases and cisplatin eligibility status.|||1.394|0.639|0.7708
72613796|NCT02516241|144756826|SUPERIORITY||Odds Ratio (OR)|0.41|||<|0.0001|TWO_SIDED|95.0|0.268|0.61||P-value was based on twice the change in log-likelihood resulting from logistic regression model, adjusting for visceral metastases and cisplatin eligibility status.|Regression, Logistic||The OR and confidence interval (CI) were calculated using logistic regression, adjusting for visceral metastases and cisplatin eligibility status.|||0.610|0.268|<0.0001
72613797|NCT02516241|144756827|SUPERIORITY||Odds Ratio (OR)|0.24|||<|0.0001|TWO_SIDED|95.0|0.135|0.406||P-value was based on twice the change in log-likelihood resulting from logistic regression model, adjusting for visceral metastases and cisplatin eligibility status.|Regression, Logistic||The OR and confidence interval (CI) were calculated using logistic regression, adjusting for visceral metastases and cisplatin eligibility status.|||0.406|0.135|<0.0001
72613798|NCT02516241|144756827|SUPERIORITY||Odds Ratio (OR)|0.86||||0.6195|TWO_SIDED|95.0|0.469|1.566||P-value was based on twice the change in log-likelihood resulting from logistic regression model, adjusting for visceral metastases and cisplatin eligibility status.|Regression, Logistic||The OR and confidence interval (CI) were calculated using logistic regression, adjusting for visceral metastases and cisplatin eligibility status.|monotherapy as reference.||1.566|0.469|0.6195
72613799|NCT02516241|144756829|SUPERIORITY||Odds Ratio (OR)|0.56||||0.0002|TWO_SIDED|95.0|0.41|0.759||P-value was based on twice the change in log-likelihood resulting from logistic regression model, adjusting for PD-L1 status, visceral metastases and cisplatin eligibility status.|Regression, Logistic||The OR and confidence interval (CI) were calculated using logistic regression, adjusting for PD-L1 status, visceral metastases and cisplatin eligibility status.|||0.759|0.410|0.0002
72613800|NCT02516241|144756829|SUPERIORITY||Odds Ratio (OR)|0.37|||<|0.0001|TWO_SIDED|95.0|0.267|0.5||P-value was based on twice the change in log-likelihood resulting from logistic regression model, adjusting for PD-L1 status, visceral metastases and cisplatin eligibility status.|Regression, Logistic||The OR and confidence interval (CI) were calculated using logistic regression, adjusting for PD-L1 status, visceral metastases and cisplatin eligibility status.|||0.500|0.267|<0.0001
72613801|NCT02516241|144756830|SUPERIORITY||Odds Ratio (OR)|0.87||||0.4959|TWO_SIDED|95.0|0.59|1.291||P-value was based on twice the change in log-likelihood resulting from logistic regression model, adjusting for visceral metastases and cisplatin eligibility status.|Regression, Logistic||The OR and confidence interval (CI) were calculated using logistic regression, adjusting for visceral metastases and cisplatin eligibility status.|||1.291|0.590|0.4959
72327335|NCT02831855|144178302|SUPERIORITY||Difference in percentage of participants|-8.52|||||TWO_SIDED|95.0|-15.27|-1.78||||||Week 36||-1.78|-15.27|
72327336|NCT02831855|144178302|SUPERIORITY||Difference in percentage of participants|-1.33|||||TWO_SIDED|95.0|-8.5|5.83|||Two Sided|||Week 48||5.83|-8.50|
72327337|NCT02831855|144178303|SUPERIORITY||Difference in percentage of participants|-8.11|||||TWO_SIDED|95.0|-15.4|-0.82||||||Week 36||-0.82|-15.40|
72327338|NCT02831855|144178303|SUPERIORITY||Difference in percentage of participants|-6.21|||||TWO_SIDED|95.0|-13.74|1.32||||||Week 48||1.32|-13.74|
72327339|NCT02831855|144178304|SUPERIORITY||Difference in percentage of participants|-5.63|||||TWO_SIDED|95.0|-14.12|2.84||||||Week 36||2.84|-14.12|
72327340|NCT02831855|144178304|SUPERIORITY||Difference in percentage of participants|-4.13|||||TWO_SIDED|95.0|-12.62|4.36||||||Week 48||4.36|-12.62|
72327341|NCT02831855|144178305|SUPERIORITY||Difference in percentage of participants|-8.84|||||TWO_SIDED|95.0|-16.44|-1.24||||||Week 36||-1.24|-16.44|
72327342|NCT02831855|144178305|SUPERIORITY||Difference in percentage of participants|-2.41|||||TWO_SIDED|95.0|-10.18|5.35||||||Week 48||5.35|-10.18|
72327343|NCT02831855|144178306|SUPERIORITY||Difference in percentage of participants|-8.85|||||TWO_SIDED|95.0|-16.38|-1.31||||||Week 36||-1.31|-16.38|
72613802|NCT02516241|144756830|SUPERIORITY||Odds Ratio (OR)|0.46||||0.0001|TWO_SIDED|95.0|0.305|0.679||P-value was based on twice the change in log-likelihood resulting from logistic regression model, adjusting for visceral metastases and cisplatin eligibility status.|Regression, Logistic||The OR and confidence interval (CI) were calculated using logistic regression, adjusting for visceral metastases and cisplatin eligibility status.|||0.679|0.305|0.0001
72613803|NCT02516241|144756831|SUPERIORITY||Odds Ratio (OR)|0.27|||<|0.0001|TWO_SIDED|95.0|0.16|0.448||P-value was based on twice the change in log-likelihood resulting from logistic regression model, adjusting for visceral metastases and cisplatin eligibility status.|Regression, Logistic||The OR and confidence interval (CI) were calculated using logistic regression, adjusting for visceral metastases and cisplatin eligibility status.|||0.448|0.160|<0.0001
72327344|NCT02831855|144178306|SUPERIORITY||Difference in percentage of participants|-3.16|||||TWO_SIDED|95.0|-10.99|4.65||||||Week 48||4.65|-10.99|
72327345|NCT02831855|144178307|SUPERIORITY||Difference in percentage of participants|-6.96|||||TWO_SIDED|95.0|-14.06|0.14||||||Week 36||0.14|-14.06|
72327346|NCT02831855|144178307|SUPERIORITY||Difference in percentage of participants|-6.59|||||TWO_SIDED|95.0|-13.8|0.61||||||Week 48||0.61|-13.80|
72327347|NCT02831855|144178308|SUPERIORITY||Difference in percentage of participants|-12.75|||||TWO_SIDED|95.0|-21.01|-4.48||||||Week 36||-4.48|-21.01|
72327348|NCT02831855|144178308|SUPERIORITY||Difference in percentage of participants|-11.99|||||TWO_SIDED|95.0|-20.22|-3.75||||||Week 48||-3.75|-20.22|
72327349|NCT02831855|144178309|SUPERIORITY||Difference in percentage of participants|-5.37|||||TWO_SIDED|95.0|-13.63|2.89||||||Week 36||2.89|-13.63|
72327350|NCT02831855|144178309|SUPERIORITY||Difference in percentage of participants|-4.97|||||TWO_SIDED|95.0|-13.32|3.36||||||Week 48||3.36|-13.32|
72327351|NCT02831855|144178310|SUPERIORITY||LS Mean Difference|0.09|STANDARD_ERROR_OF_MEAN|0.04|||TWO_SIDED|95.0|0.02|0.16||||||Change at Week 36: Linear MMRM was used that included the fixed effects of treatment, visit, treatment-by-visit interaction, prior use of a bDMARD and baseline HAQ-DI.||0.16|0.02|
72327352|NCT02831855|144178310|SUPERIORITY||LS Mean Difference|0.02|STANDARD_ERROR_OF_MEAN|0.04|||TWO_SIDED|95.0|-0.06|0.09||||||Change at Week 48: Linear MMRM was used that included the fixed effects of treatment, visit, treatment-by-visit interaction, prior use of a bDMARD and baseline HAQ-DI.||0.09|-0.06|
72327353|NCT02831855|144178311|SUPERIORITY||LS Mean Difference|-0.44|STANDARD_ERROR_OF_MEAN|0.69|||TWO_SIDED|95.0|-1.79|0.92||||||Change at Week 36: Physical Functioning- Linear MMRM was used that included the fixed effects of treatment, visit, treatment-by-visit interaction, prior use of a bDMARD, and baseline SF-36 physical component score as a covariate.||0.92|-1.79|
72327354|NCT02831855|144178311|SUPERIORITY||LS Mean Difference|0.52|STANDARD_ERROR_OF_MEAN|0.68|||TWO_SIDED|95.0|-0.82|1.85||||||Change at Week 48: Physical Functioning- Linear MMRM was used that included the fixed effects of treatment, visit, treatment-by-visit interaction, prior use of a bDMARD, and baseline SF-36 physical component score as a covariate.||1.85|-0.82|
72327355|NCT02831855|144178311|SUPERIORITY||LS Mean Difference|-1.67|STANDARD_ERROR_OF_MEAN|0.66|||TWO_SIDED|95.0|-2.97|-0.37||||||Change at Week 36: Role Physical Score- Linear MMRM was used that included the fixed effects of treatment, visit, treatment-by-visit interaction, prior use of a bDMARD, and baseline SF-36 role physical score score as a covariate.||-0.37|-2.97|
72327356|NCT02831855|144178311|SUPERIORITY||LS Mean Difference|-0.73|STANDARD_ERROR_OF_MEAN|0.66|||TWO_SIDED|95.0|-2.13|0.66||||||Change at Week 48: Role Physical Score- Linear MMRM was used that included the fixed effects of treatment, visit, treatment-by-visit interaction, prior use of a bDMARD, and baseline SF-36 role physical score score as a covariate.||0.66|-2.13|
72327357|NCT02831855|144178311|SUPERIORITY||LS Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.69|||TWO_SIDED|95.0|-1.5|1.21||||||Change at Week 36: Social functioning- Linear MMRM was used that included the fixed effects of treatment, visit, treatment-by-visit interaction, prior use of a bDMARD, and baseline SF-36 Social functioning score as a covariate.||1.21|-1.50|
72327358|NCT02831855|144178311|SUPERIORITY||LS Mean Difference|-0.51|STANDARD_ERROR_OF_MEAN|0.73|||TWO_SIDED|95.0|-1.95|0.93||||||Change at Week 48: Social functioning- Linear MMRM was used that included the fixed effects of treatment, visit, treatment-by-visit interaction, prior use of a bDMARD, and baseline SF-36 Social functioning score as a covariate.||0.93|-1.95|
72327359|NCT02831855|144178311|SUPERIORITY||LS Mean Difference|-1.45|STANDARD_ERROR_OF_MEAN|0.74|||TWO_SIDED|95.0|-2.9|-0.01||||||Change at Week 36: Bodily Pain Score- Linear MMRM was used that included the fixed effects of treatment, visit, treatment-by-visit interaction, prior use of a bDMARD, and baseline SF-36 bodily pain score as a covariate.||-0.01|-2.90|
72327360|NCT02831855|144178311|SUPERIORITY||LS Mean Difference|-0.75|STANDARD_ERROR_OF_MEAN|0.75|||TWO_SIDED|95.0|-2.23|0.73||||||Change at Week 48: Bodily Pain Score- Linear MMRM was used that included the fixed effects of treatment, visit, treatment-by-visit interaction, prior use of a bDMARD, and baseline SF-36 bodily pain score as a covariate.||0.73|-2.23|
72327361|NCT02831855|144178311|SUPERIORITY||LS Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|0.71|||TWO_SIDED|95.0|-2.29|0.49||||||Change at Week 36: Mental Health Score- Linear MMRM was used that included the fixed effects of treatment, visit, treatment-by-visit interaction, prior use of a bDMARD, and baseline SF-36 mental health score as a covariate.||0.49|-2.29|
72327362|NCT02831855|144178311|SUPERIORITY||LS Mean Difference|-0.46|STANDARD_ERROR_OF_MEAN|0.75|||TWO_SIDED|95.0|-1.94|1.02||||||Change at Week 48: Mental Health Score- Linear MMRM was used that included the fixed effects of treatment, visit, treatment-by-visit interaction, prior use of a bDMARD, and baseline SF-36 mental health score as a covariate.||1.02|-1.94|
72327363|NCT02831855|144178311|SUPERIORITY||LS Mean Difference|-1.11|STANDARD_ERROR_OF_MEAN|0.78|||TWO_SIDED|95.0|-2.64|0.43||||||Change at Week 36: Role Emotional Score- Linear MMRM was used that included the fixed effects of treatment, visit, treatment-by-visit interaction, prior use of a bDMARD, and baseline SF-36 role emotional score as a covariate.||0.43|-2.64|
72327364|NCT02831855|144178311|SUPERIORITY||LS Mean Difference|-0.47|STANDARD_ERROR_OF_MEAN|0.75|||TWO_SIDED|95.0|-1.95|1.01||||||Change at Week 48: Role Emotional Score- Linear MMRM was used that included the fixed effects of treatment, visit, treatment-by-visit interaction, prior use of a bDMARD, and baseline SF-36 role emotional score as a covariate.||1.01|-1.95|
72327365|NCT02831855|144178311|SUPERIORITY||LS Mean Difference|-1.15|STANDARD_ERROR_OF_MEAN|0.7|||TWO_SIDED|95.0|-2.52|0.22||||||Change at Week 36: Vitality Score- Linear MMRM was used that included the fixed effects of treatment, visit, treatment-by-visit interaction, prior use of a bDMARD, and baseline SF-36 vitality score as a covariate.||0.22|-2.52|
72327366|NCT02831855|144178311|SUPERIORITY||LS Mean Difference|-0.52|STANDARD_ERROR_OF_MEAN|0.73|||TWO_SIDED|95.0|-1.94|0.91||||||Change at Week 48: Vitality Score- Linear MMRM was used that included the fixed effects of treatment, visit, treatment-by-visit interaction, prior use of a bDMARD, and baseline SF-36 vitality score as a covariate.||0.91|-1.94|
72327367|NCT02831855|144178311|SUPERIORITY||LS Mean Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.61|||TWO_SIDED|95.0|-1.3|1.08||||||Change at Week 36: General Health Perception Score- Linear MMRM was used that included the fixed effects of treatment, visit, treatment-by-visit interaction, prior use of a bDMARD, and baseline SF-36 general health perception score as a covariate.||1.08|-1.30|
72327368|NCT02831855|144178311|SUPERIORITY||LS Mean Difference|0.62|STANDARD_ERROR_OF_MEAN|0.62|||TWO_SIDED|95.0|-0.6|1.83||||||Change at Week 48: General Health Perception Score- Linear MMRM was used that included the fixed effects of treatment, visit, treatment-by-visit interaction, prior use of a bDMARD, and baseline SF-36 general health perception score as a covariate.||1.83|-0.60|
72327369|NCT02831855|144178312|SUPERIORITY||LS Mean Difference|-0.82|STANDARD_ERROR_OF_MEAN|0.61|||TWO_SIDED|95.0|-2.01|0.37||||||Change at Week 36: Physical Component Score- Linear MMRM was used that included the fixed effects of treatment, visit, treatment-by-visit interaction, prior use of a bDMARD, and baseline SF-36 physical component score- as a covariate.||0.37|-2.01|
72327370|NCT02831855|144178312|SUPERIORITY||LS Mean Difference|0.09|STANDARD_ERROR_OF_MEAN|0.61|||TWO_SIDED|95.0|-1.11|1.29||||||Change at Week 48: Physical Component Score- Linear MMRM was used that included the fixed effects of treatment, visit, treatment-by-visit interaction, prior use of a biological disease-modifying anti-rheumatic drug (DMARD), and baseline SF-36 physical component score- as a covariate.||1.29|-1.11|
72327371|NCT02831855|144178312|SUPERIORITY||LS Mean Difference|-0.82|STANDARD_ERROR_OF_MEAN|0.67|||TWO_SIDED|95.0|-2.13|0.49||||||Change at Week 36: Mental Component Score- Linear MMRM was used that included the fixed effects of treatment, visit, treatment-by-visit interaction, prior use of a bDMARD, and baseline SF-36 mental component score as a covariate.||0.49|-2.13|
72327372|NCT02831855|144178312|SUPERIORITY||LS Mean Difference|-0.68|STANDARD_ERROR_OF_MEAN|0.7|||TWO_SIDED|95.0|-2.06|0.7||||||Change at Week 48: Mental Component Score- Linear MMRM was used that included the fixed effects of treatment, visit, treatment-by-visit interaction, prior use of a bDMARD, and baseline SF-36 mental component score as a covariate.||0.70|-2.06|
72327373|NCT02831855|144178313|SUPERIORITY||LS Mean Difference|1.61|STANDARD_ERROR_OF_MEAN|2.41|||TWO_SIDED|95.0|-3.14|6.37||||||Change at Week 36: Absenteeism Score- Linear MMRM was used that included the fixed effects of treatment, visit, treatment-by-visit interaction, prior use of a bDMARD, and baseline WPAI absenteeism score as a covariate.||6.37|-3.14|
72327374|NCT02831855|144178313|SUPERIORITY||LS Mean Difference|-0.51|STANDARD_ERROR_OF_MEAN|2.28|||TWO_SIDED|95.0|-5.01|3.99||||||Change at Week 48: Absenteeism Score- Linear MMRM was used that included the fixed effects of treatment, visit, treatment-by-visit interaction, prior use of a bDMARD, and baseline WPAI absenteeism score as a covariate.||3.99|-5.01|
72327375|NCT02831855|144178313|SUPERIORITY||LS Mean Difference|3.19|STANDARD_ERROR_OF_MEAN|1.88|||TWO_SIDED|95.0|-0.51|6.89||||||Change at Week 36: Daily activity impairment- Linear MMRM was used that included the fixed effects of treatment, visit, treatment-by-visit interaction, prior use of a bDMARD, and baseline WPAI daily activity impairment score as a covariate.||6.89|-0.51|
72327376|NCT02831855|144178313|SUPERIORITY||LS Mean Difference|1.6|STANDARD_ERROR_OF_MEAN|2.04|||TWO_SIDED|95.0|-2.41|5.61||||||Change at Week 48: Daily activity impairment- Linear MMRM was used that included the fixed effects of treatment, visit, treatment-by-visit interaction, prior use of a bDMARD, and baseline WPAI daily activity impairment score as a covariate.||5.61|-2.41|
72327377|NCT02831855|144178313|SUPERIORITY||LS Mean Difference|3.01|STANDARD_ERROR_OF_MEAN|2.97|||TWO_SIDED|95.0|-2.84|8.87||||||Change at Week 36: Presenteeism- Linear MMRM was used that included the fixed effects of treatment, visit, treatment-by-visit interaction, prior use of a bDMARD, and baseline WPAI presenteeism score as a covariate.||8.87|-2.84|
72327378|NCT02831855|144178313|SUPERIORITY||LS Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|3.77|||TWO_SIDED|95.0|-8.34|6.54||||||Change at Week 48: Presenteeism- Linear MMRM was used that included the fixed effects of treatment, visit, treatment-by-visit interaction, prior use of a bDMARD, and baseline WPAI presenteeism score as a covariate.||6.54|-8.34|
72327379|NCT02831855|144178313|SUPERIORITY||LS Mean Difference|2.84|STANDARD_ERROR_OF_MEAN|3.45|||TWO_SIDED|95.0|-3.97|9.65||||||Change at Week 36: Work productivity loss- Linear MMRM was used that included the fixed effects of treatment, visit, treatment-by-visit interaction, prior use of a bDMARD, and baseline WPAI work productivity loss score as a covariate.||9.65|-3.97|
72613804|NCT02516241|144756831|SUPERIORITY||Odds Ratio (OR)|1.07||||0.8074|TWO_SIDED|95.0|0.623|1.836||P-value was based on twice the change in log-likelihood resulting from logistic regression model, adjusting for visceral metastases and cisplatin eligibility status.|Regression, Logistic||The OR and confidence interval (CI) were calculated using logistic regression, adjusting for visceral metastases and cisplatin eligibility status.|monotherapy as reference.||1.836|0.623|0.8074
72613805|NCT02516241|144756832|SUPERIORITY||Odds Ratio (OR)|0.59||||0.0008|TWO_SIDED|95.0|0.432|0.802||P-value was based on twice the change in log-likelihood resulting from logistic regression model, adjusting for PD-L1 status, visceral metastases and cisplatin eligibility status.|Regression, Logistic||The OR and confidence interval (CI) were calculated using logistic regression, adjusting for PD-L1 status, visceral metastases and cisplatin eligibility status.|||0.802|0.432|0.0008
72613806|NCT02516241|144756832|SUPERIORITY||Odds Ratio (OR)|0.37|||<|0.0001|TWO_SIDED|95.0|0.27|0.512||P-value was based on twice the change in log-likelihood resulting from logistic regression model, adjusting for PD-L1 status, visceral metastases and cisplatin eligibility status.|Regression, Logistic||The OR and confidence interval (CI) were calculated using logistic regression, adjusting for PD-L1 status, visceral metastases and cisplatin eligibility status.|||0.512|0.270|<0.0001
72613807|NCT02516241|144756833|SUPERIORITY||Odds Ratio (OR)|0.94||||0.7717|TWO_SIDED|95.0|0.639|1.394||P-value was based on twice the change in log-likelihood resulting from logistic regression model, adjusting for visceral metastases and cisplatin eligibility status.|Regression, Logistic||The OR and confidence interval (CI) were calculated using logistic regression, adjusting for visceral metastases and cisplatin eligibility status.|||1.394|0.639|0.7717
72613808|NCT02516241|144756833|SUPERIORITY||Odds Ratio (OR)|0.46||||0.0001|TWO_SIDED|95.0|0.303|0.682||P-value was based on twice the change in log-likelihood resulting from logistic regression model, adjusting for visceral metastases and cisplatin eligibility status.|Regression, Logistic||The OR and confidence interval (CI) were calculated using logistic regression, adjusting for visceral metastases and cisplatin eligibility status.|||0.682|0.303|0.0001
72613809|NCT02516241|144756834|SUPERIORITY||Odds Ratio (OR)|0.26|||<|0.0001|TWO_SIDED|95.0|0.151|0.439||P-value was based on twice the change in log-likelihood resulting from logistic regression model, adjusting for visceral metastases and cisplatin eligibility status.|Regression, Logistic||The OR and confidence interval (CI) were calculated using logistic regression, adjusting for visceral metastases and cisplatin eligibility status.|||0.439|0.151|<0.0001
72613810|NCT02516241|144756834|SUPERIORITY||Odds Ratio (OR)|0.99||||0.9692|TWO_SIDED|95.0|0.556|1.759||P-value was based on twice the change in log-likelihood resulting from logistic regression model, adjusting for visceral metastases and cisplatin eligibility status.|Regression, Logistic||The OR and confidence interval (CI) were calculated using logistic regression, adjusting for visceral metastases and cisplatin eligibility status.|monotherapy as reference.||1.759|0.556|0.9692
72613811|NCT02516241|144756842|SUPERIORITY||Mean Difference (Final Values)|1.5||||0.1617|TWO_SIDED|95.0|-0.6|3.59||MMRM model included patient, treatment, cisplatin eligibility, PD-L1 status and visceral metastasis, visit and treatment by visit interaction as explanatory variables, and the appropriate baseline FACT-BL value as a covariate.|Mixed Models Analysis|||NFBLSI- 18 score (Average overall visits)||3.59|-0.6|0.1617
72613812|NCT02516241|144756842|SUPERIORITY||Mean Difference (Final Values)|2.1||||0.0578|TWO_SIDED|95.0|-0.07|4.29||MMRM model included patient, treatment, cisplatin eligibility, PD-L1 status and visceral metastasis, visit and treatment by visit interaction as explanatory variables, and the appropriate baseline FACT-BL value as a covariate.|Mixed Models Analysis|||NFBLSI- 18 score (Average overall visits)||4.29|-0.07|0.0578
72613813|NCT02516241|144756842|SUPERIORITY||Mean Difference (Final Values)|1.7||||0.2003|TWO_SIDED|95.0|-0.91|4.32||MMRM model included patient, treatment, cisplatin eligibility, PD-L1 status and visceral metastasis, visit and treatment by visit interaction as explanatory variables, and the appropriate baseline FACT-BL value as a covariate.|Mixed Models Analysis|||FACT-BL TOI (Average overall visits)||4.32|-0.91|0.2003
72613814|NCT02516241|144756842|SUPERIORITY||Mean Difference (Final Values)|3.3||||0.0178|TWO_SIDED|95.0|0.57|6.0||MMRM model included patient, treatment, cisplatin eligibility, PD-L1 status and visceral metastasis, visit and treatment by visit interaction as explanatory variables, and the appropriate baseline FACT-BL value as a covariate.|Mixed Models Analysis|||FACT-BL TOI (Average overall visits)||6.00|0.57|0.0178
72613815|NCT02516241|144756842|SUPERIORITY||Mean Difference (Final Values)|1.6||||0.3765|TWO_SIDED|95.0|-1.96|5.17||MMRM model included patient, treatment, cisplatin eligibility, PD-L1 status and visceral metastasis, visit and treatment by visit interaction as explanatory variables, and the appropriate baseline FACT-BL value as a covariate.|Mixed Models Analysis|||FACT-BL Total score (Average overall visits)||5.17|-1.96|0.3765
72613816|NCT02516241|144756842|SUPERIORITY||Mean Difference (Final Values)|4.1||||0.03|TWO_SIDED|95.0|0.4|7.81||MMRM model included patient, treatment, cisplatin eligibility, PD-L1 status and visceral metastasis, visit and treatment by visit interaction as explanatory variables, and the appropriate baseline FACT-BL value as a covariate.|Mixed Models Analysis|||FACT-BL Total score (Average overall visits)||7.81|0.40|0.0300
72613817|NCT02516241|144756843|SUPERIORITY||Mean Difference (Final Values)|1.9||||0.1373|TWO_SIDED|95.0|-0.6|4.36||MMRM model included patient, treatment, cisplatin eligibility and visceral metastasis, visit and treatment by visit interaction as explanatory variables, and the appropriate baseline FACT-BL value as a covariate.|Mixed Models Analysis|||NFBLSI- 18 score (Average overall visits)||4.36|-0.6|0.1373
72613818|NCT02516241|144756843|SUPERIORITY||Mean Difference (Final Values)|3.8||||0.0034|TWO_SIDED|95.0|1.26|6.27||MMRM model included patient, treatment, cisplatin eligibility and visceral metastasis, visit and treatment by visit interaction as explanatory variables, and the appropriate baseline FACT-BL value as a covariate.|Mixed Models Analysis|||NFBLSI- 18 score (Average overall visits)||6.27|1.26|0.0034
72613819|NCT02516241|144756843|SUPERIORITY||Mean Difference (Final Values)|2.2||||0.1774|TWO_SIDED|95.0|-1.0|5.39||MMRM model included patient, treatment, cisplatin eligibility and visceral metastasis, visit and treatment by visit interaction as explanatory variables, and the appropriate baseline FACT-BL value as a covariate.|Mixed Models Analysis|||FACT-BL TOI (Average overall visits)||5.39|-1.00|0.1774
72613820|NCT02516241|144756843|SUPERIORITY||Mean Difference (Final Values)|5.4||||0.0011|TWO_SIDED|95.0|2.19|8.65||MMRM model included patient, treatment, cisplatin eligibility and visceral metastasis, visit and treatment by visit interaction as explanatory variables, and the appropriate baseline FACT-BL value as a covariate.|Mixed Models Analysis|||FACT-BL TOI (Average overall visits)||8.65|2.19|0.0011
72613821|NCT02516241|144756843|SUPERIORITY||Mean Difference (Final Values)|2.1||||0.3494|TWO_SIDED|95.0|-2.27|6.38||MMRM model included patient, treatment, cisplatin eligibility and visceral metastasis, visit and treatment by visit interaction as explanatory variables, and the appropriate baseline FACT-BL value as a covariate.|Mixed Models Analysis|||FACT-BL Total score (Average overall visits)||6.38|-2.27|0.3494
72613822|NCT02516241|144756843|SUPERIORITY||Mean Difference (Final Values)|7.3||||0.0011|TWO_SIDED|95.0|2.96|11.71||MMRM model included patient, treatment, cisplatin eligibility and visceral metastasis, visit and treatment by visit interaction as explanatory variables, and the appropriate baseline FACT-BL value as a covariate.|Mixed Models Analysis|||FACT-BL Total score (Average overall visits)||11.71|2.96|0.0011
72613823|NCT02516241|144756844|SUPERIORITY||Mean Difference (Final Values)|-1.3||||0.3865|TWO_SIDED|95.0|-4.35|1.69||MMRM model included patient, treatment, cisplatin eligibility and visceral metastasis, visit and treatment by visit interaction as explanatory variables, and the appropriate baseline FACT-BL value as a covariate.|Mixed Models Analysis|||NFBLSI- 18 score (Average overall visits)||1.69|-4.35|0.3865
72613824|NCT02516241|144756844|SUPERIORITY||Mean Difference (Final Values)|-1.8||||0.284|TWO_SIDED|95.0|-5.05|1.49||MMRM model included patient, treatment, cisplatin eligibility and visceral metastasis, visit and treatment by visit interaction as explanatory variables, and the appropriate baseline FACT-BL value as a covariate.|Mixed Models Analysis|||NFBLSI- 18 score (Average overall visits)||1.49|-5.05|0.2840
72613825|NCT02516241|144756844|SUPERIORITY||Mean Difference (Final Values)|-1.9||||0.297|TWO_SIDED|95.0|-5.41|1.66||MMRM model included patient, treatment, cisplatin eligibility and visceral metastasis, visit and treatment by visit interaction as explanatory variables, and the appropriate baseline FACT-BL value as a covariate.|Mixed Models Analysis|||FACT-BL TOI (Average overall visits)||1.66|-5.41|0.2970
72327380|NCT02831855|144178313|SUPERIORITY||LS Mean Difference|-2.46|STANDARD_ERROR_OF_MEAN|4.19|||TWO_SIDED|95.0|-10.72|5.8||||||Change at Week 48: Work productivity loss- Linear MMRM was used that included the fixed effects of treatment, visit, treatment-by-visit interaction, prior use of a bDMARD, and baseline WPAI work productivity loss score as a covariate.||5.80|-10.72|
72327381|NCT02831855|144178314|SUPERIORITY||LS Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.02|||TWO_SIDED|95.0|-0.07|-0.01||||||Change at Week 36: Linear MMRM was used that included the fixed effects of treatment, visit, treatment-by-visit interaction, prior use of a bDMARD, and baseline EQ-5D score as a covariate.||-0.01|-0.07|
72327382|NCT02831855|144178314|SUPERIORITY||LS Mean Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.02|||TWO_SIDED|95.0|-0.06|0.01||||||Change at Week 48: Linear MMRM was used that included the fixed effects of treatment, visit, treatment-by-visit interaction, prior use of a bDMARD, and baseline EQ-5D score as a covariate.||0.01|-0.06|
72613826|NCT02516241|144756844|SUPERIORITY||Mean Difference (Final Values)|-2.0||||0.3026|TWO_SIDED|95.0|-5.85|1.83||MMRM model included patient, treatment, cisplatin eligibility and visceral metastasis, visit and treatment by visit interaction as explanatory variables, and the appropriate baseline FACT-BL value as a covariate.|Mixed Models Analysis|||FACT-BL TOI (Average overall visits)||1.83|-5.85|0.3026
72613827|NCT02516241|144756844|SUPERIORITY||Mean Difference (Final Values)|-2.5||||0.3168|TWO_SIDED|95.0|-7.29|2.38||MMRM model included patient, treatment, cisplatin eligibility and visceral metastasis, visit and treatment by visit interaction as explanatory variables, and the appropriate baseline FACT-BL value as a covariate.|Mixed Models Analysis|||FACT-BL Total score (Average overall visits)||2.38|-7.29|0.3168
72613828|NCT02516241|144756844|SUPERIORITY||Mean Difference (Final Values)|-3.3||||0.2179|TWO_SIDED|95.0|-8.51|1.96||MMRM model included patient, treatment, cisplatin eligibility and visceral metastasis, visit and treatment by visit interaction as explanatory variables, and the appropriate baseline FACT-BL value as a covariate.|Mixed Models Analysis|||FACT-BL Total score (Average overall visits)||1.96|-8.51|0.2179
72613829|NCT02516241|144756845|SUPERIORITY||Odds Ratio (OR)|1.4||||0.2419|TWO_SIDED|95.0|0.8|2.6||P-value was based on twice the change in log-likelihood resulting from logistic regression model, adjusting for PD-L1 status, visceral metastases and cisplatin eligibility status.|Regression, Logistic||The OR and confidence interval (CI) were calculated using logistic regression, adjusting for PD-L1 status, visceral metastases and cisplatin eligibility status, with 95% CI calculated by profile likelihood|Patients with improvement in fatigue||2.6|0.8|0.2419
72613830|NCT02516241|144756845|SUPERIORITY||Odds Ratio (OR)|1.5||||0.1553|TWO_SIDED|95.0|0.9|2.8||P-value was based on twice the change in log-likelihood resulting from logistic regression model, adjusting for PD-L1 status, visceral metastases and cisplatin eligibility status.|Regression, Logistic||The OR and confidence interval (CI) were calculated using logistic regression, adjusting for PD-L1 status, visceral metastases and cisplatin eligibility status, with 95% CI calculated by profile likelihood.|Patients with improvement in fatigue||2.8|0.9|0.1553
72613831|NCT02516241|144756845|SUPERIORITY||Odds Ratio (OR)|2.0||||0.0003|TWO_SIDED|95.0|1.4|2.8||P-value was based on twice the change in log-likelihood resulting from logistic regression model, adjusting for PD-L1 status, visceral metastases and cisplatin eligibility status.|Regression, Logistic||The OR and confidence interval (CI) were calculated using logistic regression, adjusting for PD-L1 status, visceral metastases and cisplatin eligibility status, with 95% CI calculated by profile likelihood.|Patient with deterioration in pain||2.8|1.4|0.0003
72613832|NCT02516241|144756845|SUPERIORITY||Odds Ratio (OR)|1.6||||0.0148|TWO_SIDED|95.0|1.1|2.3||P-value was based on twice the change in log-likelihood resulting from logistic regression model, adjusting for PD-L1 status, visceral metastases and cisplatin eligibility status.|Regression, Logistic||The OR and confidence interval (CI) were calculated using logistic regression, adjusting for PD-L1 status, visceral metastases and cisplatin eligibility status, with 95% CI calculated by profile likelihood.|Patient with deterioration in pain||2.3|1.1|0.0148
72613833|NCT02516241|144756846|SUPERIORITY||Odds Ratio (OR)|1.6||||0.2473|TWO_SIDED|95.0|0.7|3.4||P-value was based on twice the change in log-likelihood resulting from logistic regression model, adjusting for visceral metastases and cisplatin eligibility status.|Regression, Logistic||The OR and confidence interval (CI) were calculated using logistic regression, adjusting for visceral metastases and cisplatin eligibility status, with 95% CI calculated by profile likelihood.|Patients with improvement in fatigue||3.4|0.7|0.2473
72613834|NCT02516241|144756846|SUPERIORITY||Odds Ratio (OR)|1.7||||0.0148|TWO_SIDED|95.0|0.8|3.8||P-value was based on twice the change in log-likelihood resulting from logistic regression model, adjusting for visceral metastases and cisplatin eligibility status.|Regression, Logistic||The OR and confidence interval (CI) were calculated using logistic regression, adjusting for visceral metastases and cisplatin eligibility status, with 95% CI calculated by profile likelihood.|Patients with improvement in fatigue||3.8|0.8|0.0148
72613835|NCT02516241|144756846|SUPERIORITY||Odds Ratio (OR)|1.9||||0.009|TWO_SIDED|95.0|1.2|3.0||P-value was based on twice the change in log-likelihood resulting from logistic regression model, adjusting for visceral metastases and cisplatin eligibility status.|Regression, Logistic||The OR and confidence interval (CI) were calculated using logistic regression, adjusting for visceral metastases and cisplatin eligibility status, with 95% CI calculated by profile likelihood|Patient with deterioration in pain||3.0|1.2|0.0090
72613836|NCT02516241|144756846|SUPERIORITY||Odds Ratio (OR)|1.4||||0.151|TWO_SIDED|95.0|0.9|2.3||P-value was based on twice the change in log-likelihood resulting from logistic regression model, adjusting for visceral metastases and cisplatin eligibility status.|Regression, Logistic||The OR and confidence interval (CI) were calculated using logistic regression, adjusting for visceral metastases and cisplatin eligibility status, with 95% CI calculated by profile likelihood.|Patient with deterioration in pain||2.3|0.9|0.1510
72327383|NCT02831855|144178315|SUPERIORITY||LS Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.6|||TWO_SIDED|95.0|-1.37|1.0||||||Change at Week 36: Linear MMRM was used that included the fixed effects of treatment, visit, treatment-by-visit interaction, prior use of a bDMARD, and baseline FACIT - fatigue scale score as a covariate.||1.00|-1.37|
72613837|NCT02516241|144756847|SUPERIORITY||Odds Ratio (OR)|1.2||||0.6763|TWO_SIDED|95.0|0.5|3.2||P-value was based on twice the change in log-likelihood resulting from logistic regression model, adjusting for visceral metastases and cisplatin eligibility status.|Regression, Logistic||The OR and confidence interval (CI) were calculated using logistic regression, adjusting for visceral metastases and cisplatin eligibility status, with 95% CI calculated by profile likelihood.|Patients with improvement in fatigue||3.2|0.5|0.6763
72613838|NCT02516241|144756847|SUPERIORITY||Odds Ratio (OR)|1.2||||0.6539|TWO_SIDED|95.0|0.5|3.3||P-value was based on twice the change in log-likelihood resulting from logistic regression model, adjusting for visceral metastases and cisplatin eligibility status.|Regression, Logistic||The OR and confidence interval (CI) were calculated using logistic regression, adjusting for visceral metastases and cisplatin eligibility status, with 95% CI calculated by profile likelihood.|Patients with improvement in fatigue||3.3|0.5|0.6539
72613839|NCT02516241|144756847|SUPERIORITY||Odds Ratio (OR)|2.2||||0.0092|TWO_SIDED|95.0|1.2|4.0||P-value was based on twice the change in log-likelihood resulting from logistic regression model, adjusting for visceral metastases and cisplatin eligibility status.|Regression, Logistic||The OR and confidence interval (CI) were calculated using logistic regression, adjusting for visceral metastases and cisplatin eligibility status, with 95% CI calculated by profile likelihood|Patient with deterioration in pain||4.0|1.2|0.0092
72613840|NCT02516241|144756847|SUPERIORITY||Odds Ratio (OR)|1.9||||0.0324|TWO_SIDED|95.0|1.1|3.5||P-value was based on twice the change in log-likelihood resulting from logistic regression model, adjusting for visceral metastases and cisplatin eligibility status.|Regression, Logistic||The OR and confidence interval (CI) were calculated using logistic regression, adjusting for visceral metastases and cisplatin eligibility status, with 95% CI calculated by profile likelihood.|Patient with deterioration in pain||3.5|1.1|0.0324
72613841|NCT00724945|144756853|SUPERIORITY_OR_OTHER||Least Square Mean|-0.08591|STANDARD_ERROR_OF_MEAN|0.008816||||95.0|-0.08591|-0.06857|||Mixed Models Analysis|||Alternative hypothesis: senofilcon A multifocal would be better than or equal to 0.1 logMAR units.||-0.06857|-0.08591|
72613842|NCT00724945|144756854|SUPERIORITY_OR_OTHER||Least Square Mean|0.02711|STANDARD_ERROR_OF_MEAN|0.008816||||97.5|0.02711|0.04445|||Mixed Models Analysis|||Alternative hypothesis: senofilcon A multifocal lens would be better than or equal to 0.17 logMAR units.||0.04445|0.02711|
72613843|NCT00724945|144756855|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin is -0.5.|Mean Difference (Final Values)|0.07407|STANDARD_ERROR_OF_MEAN|0.1279||||97.5|-0.1797|0.07407|||Mixed Models Analysis||Mean difference was calculated as senofilcon A multifocal minus balafilcon A multifocal.|Alternative hypothesis: senofilcon A multifocal lens will have subjective vision that is non-inferior to balafilcon A multifocal.||0.07407|-0.1797|
72613844|NCT01348269|144756952|OTHER|T-test (with MITT, omitting outlier value of one patient in placebo group)|||||=|0.006|||||||t-test, 2 sided|||||||=0.006
72613845|NCT01348269|144756952|OTHER|Mann-Whitney-Test|||||=|0.015|||||||Wilcoxon (Mann-Whitney)|||||||=0.015
72613846|NCT02452190|144757012|SUPERIORITY|A fixed-sequence multiple testing procedure was implemented to test the primary and secondary endpoints while controlling the overall Type I error rate at 0.05. At the point where p\>0.05, no further comparisons were interpreted inferentially.|CAE rate ratio (reslizumab vs placebo)|0.79||||0.194|TWO_SIDED|95.0|0.562|1.124||The treatment effect was tested using the likelihood based Chi-square test at the 0.05 significance level.|Chi-squared|||The frequency of CAEs was analyzed using the generalized linear model (GLM) for data from the negative binomial distributions that is commonly referred to as the negative binomial (NB) regression model. The primary NB model included the treatment group, randomization stratification factors, and number of prior exacerbations as model factors and the logarithm of treatment duration excluding the summed duration of exacerbations in the treatment period as an offset variable.||1.124|0.562|0.194
72613847|NCT03112603|144757064|OTHER||Odds Ratio (OR)|2.99|||<|0.0001|TWO_SIDED|95.0|1.86|4.8|||Cochran-Mantel-Haenszel|||||4.80|1.86|<0.0001
72613848|NCT03112603|144757066|OTHER||Hazard Ratio (HR)|0.37|||<|0.0001|TWO_SIDED|95.0|0.268|0.51||The p-value was derived from a 1-sided stratified log-rank test.|Log Rank||The hazard ratio was obtained from a stratified Cox model using cGvHD severity at randomization as strata.|||0.510|0.268|<0.0001
72613849|NCT03112603|144757067|OTHER||Hazard Ratio (HR)|0.361|||||TWO_SIDED|95.0|0.268|0.485|||||The hazard ratio was obtained from a stratified Cox model using cGvHD severity at randomization as strata.|||0.485|0.268|
72613850|NCT03112603|144757068|OTHER||Odds Ratio (OR)|2.17||||0.0011|TWO_SIDED|95.0|1.34|3.52||The one-sided p-value was calculated using a stratified Cochran-Mantel-Haenszel test.|Cochran-Mantel-Haenszel||The odds ratio and 95% confidence interval (CI) were calculated using a stratified Cochran-Mantel-Haenszel test.|||3.52|1.34|0.0011
72613851|NCT03112603|144757070|OTHER||Odds Ratio (OR)|2.77|||<|0.0001|TWO_SIDED|95.0|1.75|4.39||The one-sided p-value was calculated using a stratified Cochran-Mantel-Haenszel (CMH) test.|Cochran-Mantel-Haenszel||The odds ratio and 95% CI were calculated using a stratified CMH test.|||4.39|1.75|<0.0001
72613852|NCT03112603|144757072|OTHER||Hazard Ratio (HR)|0.851||||0.2396|TWO_SIDED|95.0|0.544|1.331||The p-value was derived from a 1-sided stratified log-rank test.|Log Rank||The hazard ratio was obtained from a stratified Cox model using cGvHD severity at randomization as strata.|||1.331|0.544|0.2396
72613853|NCT04725188|144757107|SUPERIORITY||Hazard Ratio (HR)|0.77||||0.091|TWO_SIDED|95.0|0.53|1.13|||Regression, Cox|||||1.13|0.53|0.0910
72613854|NCT04725188|144757107|SUPERIORITY||Hazard Ratio (HR)|1.4||||0.9622|TWO_SIDED|95.0|0.96|2.02|||Regression, Cox|||||2.02|0.96|0.9622
72613855|NCT04725188|144757108|SUPERIORITY||Difference in percentage|14.7||||0.0113|TWO_SIDED|95.0|2.1|26.9|||Miettinen & Nurminen method|||||26.9|2.1|0.0113
72613856|NCT04725188|144757108|SUPERIORITY||Difference in percentage|-9.4||||0.975|TWO_SIDED|95.0|-19.6|0.0|||Miettinen & Nurminen method|||||0.0|-19.6|0.9750
72613857|NCT04725188|144757109|SUPERIORITY||Hazard Ratio (HR)|0.76||||0.0943|TWO_SIDED|95.0|0.5|1.15|||Regression, Cox|||||1.15|0.50|0.0943
72613858|NCT04725188|144757109|SUPERIORITY||Hazard Ratio (HR)|1.05||||0.5974|TWO_SIDED|95.0|0.7|1.58|||Regression, Cox|||||1.58|0.70|0.5974
72613859|NCT02320175|144757123|OTHER|We compared percent top-box experience ratings pre- vs. post-intervention using a GEE chi-squared test for binary outcomes, clustered by site. Top-box score was calculated as the percentage of participants that gave the top-most response for the given survey item (e.g., 5=Extremely; 5=Excellent). Missing data was accounted for through use of multiple imputations appropriate for missing data in clustered studies.|||||<|0.05|||||||GEE chi-squared test for binary outcomes|||||||<.05
72613860|NCT00876343|144757129|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.2||||0.006|TWO_SIDED|95.0|-3.7|-0.6|||ANCOVA|||||-0.6|-3.7|0.006
72613861|NCT00876343|144757129|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.1|||<|0.001|TWO_SIDED|95.0|-4.6|-1.5|||ANCOVA|||||-1.5|-4.6|<0.001
72613862|NCT03116230|144757154|OTHER|||||||0.005|||||||t-test, 2 sided|Treatment A vs Control||||||0.005
72613863|NCT03116230|144757154|OTHER|||||||0.64|||||||t-test, 2 sided|Treatment B vs Control||||||0.64
72613864|NCT01933932|144757158|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.93||||0.4355|TWO_SIDED|95.0|0.77|1.12|||Log Rank|Analysis stratified by WHO performance status at randomisation.||||1.12|0.77|0.4355
72613865|NCT01933932|144757159|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.05||||0.6431|TWO_SIDED|95.0|0.85|1.3|||Log Rank|Analysis stratified by WHO performance status at randomisation.||||1.30|0.85|0.6431
72613866|NCT01933932|144757160|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.61||||0.0515|TWO_SIDED|95.0|1.0|2.62|||Regression, Logistic|Analysis stratified by WHO performance status at randomisation||||2.62|1.00|0.0515
72613867|NCT01933932|144757162|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.17||||0.5007|TWO_SIDED|95.0|0.74|1.86|||Regression, Logistic|Analysis stratified by WHO performance status at randomisation||||1.86|0.74|0.5007
72613868|NCT01933932|144757163|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.9||||0.3438|TWO_SIDED|95.0|0.74|1.11|||Log Rank|Analysis stratified by WHO performance status at randomisation.||||1.11|0.74|0.3438
72613869|NCT05258721|144757164|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|||||||<0.001
72613870|NCT05258721|144757165|SUPERIORITY||||||<|0.001||||||The threshold for statistical significance was p =0.05|Kruskal-Wallis|||||||<0.001
72613871|NCT05258721|144757166|SUPERIORITY||||||<|0.001|||||||Wilcoxon signed rank test|||||||<0.001
72613872|NCT00230737|144757168|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3594.0|||<|0.001|TWO_SIDED||||||t-test, 2 sided|||||||<0.001
72613873|NCT00848185|144757169|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA|||ANOVA for three groups||||<0.001
72613874|NCT00790036|144757170|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.92||||0.276|TWO_SIDED|95.0|0.69|1.22||P-value was obtained from the one-sided unstratified log rank test.|Log Rank|||||1.22|0.69|0.276
72613875|NCT00790036|144757171|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.75|||||TWO_SIDED|95.0|0.52|1.09||There was no formal testing of the OS between treatment since the primary endpoint was not statistically significant.||||||1.09|0.52|
72613876|NCT00790036|144757172|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.66|||||TWO_SIDED|95.0|0.41|1.07||||||||1.07|0.41|
72613877|NCT05495997|144757199|SUPERIORITY|||||||0.015|||||||ANCOVA|||Mental Imagery Group (PD-MI) compared to Psychoeducation Control Group (PD-Con) at 6 weeks compared to baseline (group-by-time interaction)||||0.015
72613878|NCT05495997|144757200|SUPERIORITY|||||||0.993|||||||ANCOVA|||Mental Imagery Group (PD-MI) compared to Psychoeducation Control Group (PD-Con) at 18 weeks compared to baseline (group-by-time interaction)||||0.993
72613879|NCT05495997|144757201|SUPERIORITY|||||||0.517|||||||ANCOVA|||Mental Imagery Group (PD-MI) compared to Psychoeducation Control Group (PD-Con) at 6 weeks compared to baseline (group-by-time interaction)||||0.517
72613880|NCT05495997|144757202|SUPERIORITY|||||||0.817|||||||ANCOVA|||Mental Imagery Group (PD-MI) compared to Psychoeducation Control Group (PD-Con) at 18 weeks compared to baseline (group-by-time interaction)||||0.817
72613881|NCT03785366|144757210|OTHER|"For the primary analysis, a ANOVA model with treatment as a fixed effect and subject as a random effect was used to analyze the uncorrected PK parameters Cmax, Cmean, and AUC0-56 days.~Analysis methodology for the secondary analysis mirrored the approach for the primary analysis applied to the baseline-corrected PK parameters."|test to Reference geometric mean ratio|0.93|||||TWO_SIDED|90.0|0.8|1.25|||ANCOVA|||||1.25|0.80|
72613882|NCT04153864|144757232|NON_INFERIORITY|The Non-Inferiority Margin (NIM) was defined as 10% of the mean EPDS score in the Specialist group (8.91), which corresponded to a value of 0.89. This predetermined NIM of 10% aligns with noninferiority guidelines and ensures clinically meaningful conclusions.|Mean Difference (Final Values)|0.36|||<|0.05|ONE_SIDED|95.0||0.86|||t-test, 1 sided|||Behavioral Activation (BA) delivered by Non-Specialists will be non-inferior to BA delivered by Specialists if the upper limit of the 95% confidence interval for the estimated mean difference in EPDS scores is less than the pre-specified 10% non-inferiority margin (NIM).||0.86||<0.05
72613883|NCT04153864|144757232|NON_INFERIORITY|The NIM was defined as 13% of the mean EPDS score in the In-Person group (8.92), which corresponded to a value of 1.16. This predetermined NIM of 13% aligns with noninferiority guidelines and ensures clinically meaningful conclusions.|Mean Difference (Final Values)|0.23|||<|0.05|ONE_SIDED|95.0||0.77|||t-test, 1 sided|||Behavioral Activation (BA) delivered via Telemedicine will be non-inferior to BA delivered In-Person if the upper limit of the 95% confidence interval for the estimated mean difference in EPDS scores is less than the pre-specified 13% non-inferiority margin (NIM). Please note, this presents the Intention to Treat (ITT) analysis.||0.77||<0.05
72327384|NCT02831855|144178315|SUPERIORITY||LS Mean Difference|0.18|STANDARD_ERROR_OF_MEAN|0.64|||TWO_SIDED|95.0|-1.07|1.44||||||Change at Week 48: Linear MMRM was used that included the fixed effects of treatment, visit, treatment-by-visit interaction, prior use of a bDMARD, and baseline FACIT - fatigue scale score as a covariate.||1.44|-1.07|
72613884|NCT04153864|144757232|NON_INFERIORITY|The NIM was defined as 13% of the mean EPDS score in the In-Person group (8.81), which corresponded to a value of 1.15. This predetermined NIM of 13% aligns with noninferiority guidelines and ensures clinically meaningful conclusions.|Mean Difference (Final Values)|0.36|||<|0.05|ONE_SIDED|95.0||0.91|||t-test, 1 sided|||Behavioral Activation (BA) delivered via Telemedicine will be non-inferior to BA delivered In-Person if the upper limit of the 95% confidence interval for the estimated mean difference in EPDS scores is less than the pre-specified 13% non-inferiority margin (NIM). Please note, this is per protocol analysis. Due to institutional pandemic-related restrictions, 21 participants were switched from In-Person to Telemedicine and met criteria for the per protocol analyses.||0.91||<0.05
72613885|NCT04153864|144757234|NON_INFERIORITY|The NIM was defined as 10% of the mean GAD-7 score for the Specialist group (6.36), which corresponded to a value of 0.64. This predetermined NIM of 10% aligns with noninferiority guidelines and ensures clinically meaningful conclusions.|Mean Difference (Final Values)|0.08|||<|0.05|ONE_SIDED|95.0||0.57|||t-test, 1 sided|||Behavioral Activation (BA) delivered by Non-Specialists will be non-inferior to BA delivered by Specialists if the upper limit of the 95% confidence interval for the estimated mean difference in GAD-7 scores is less than the pre-specified 10% non-inferiority margin (NIM).This analysis was performed on 3-months post-randomization scores.||0.57||<0.05
72613886|NCT04153864|144757234|NON_INFERIORITY|The NIM was defined as 13% of the mean GAD-7 score in the In-Person group (6.29), which corresponded to a value of 0.82. This predetermined NIM of 13% aligns with noninferiority guidelines and ensures clinically meaningful conclusions.|Mean Difference (Final Values)|0.14|||<|0.05|ONE_SIDED|95.0||0.73|||t-test, 1 sided|||Behavioral Activation (BA) delivered via Telemedicine will be non-inferior to BA delivered In-Person if the upper limit of the 95% confidence interval for the estimated mean difference in GAD-7 scores is less than the pre-specified 13% non-inferiority margin (NIM). Please note, this presents the Intention to Treat (ITT) analysis.||0.73||<0.05
72613887|NCT02629159|144757243|SUPERIORITY|In order to preserve Type I error, a step-down approach was used to test the primary and ranked key secondary endpoints in a pre-specified order where statistical significance at the 0.05 level could be claimed for a lower ranked endpoint only if the previous endpoint in the sequence met the requirements of significance.|Response Rate Difference|34.1|||<|0.001|TWO_SIDED|95.0|29.0|39.2||This comparison was the primary analysis for US/FDA regulatory purposes, and a ranked key secondary endpoint for EU/EMA regulatory purposes.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification factor of prior biological DMARD use|Response Rate Difference = Upadacitinib - Placebo|||39.2|29.0|<0.001
72613888|NCT02629159|144757243|SUPERIORITY||Response Rate Difference|7.5||||0.018|TWO_SIDED|95.0|1.2|13.8||This comparison was not part of the pre-specified multiplicity testing sequence.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification factor of prior biological DMARD use|Response Rate Difference = Upadacitinib - Adalimumab|||13.8|1.2|0.018
72613889|NCT02629159|144757244|SUPERIORITY|In order to preserve Type I error, a step-down approach was used to test the primary and ranked key secondary endpoints in a pre-specified order where statistical significance at the 0.05 level could be claimed for a lower ranked endpoint only if the previous endpoint in the sequence met the requirements of significance.|Response Rate Difference|22.6|||<|0.001|TWO_SIDED|95.0|18.6|26.5||This comparison was the primary analysis for EU/EMA regulatory purposes, and a ranked key secondary endpoint for US/FDA regulatory purposes.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification factor of prior biological DMARD use|Response Rate Difference = Upadacitinib - Placebo|||26.5|18.6|<0.001
72613890|NCT02629159|144757244|SUPERIORITY||Response Rate Difference|10.7|||<|0.001|TWO_SIDED|95.0|5.3|16.1||This comparison was not part of the pre-specified multiplicity testing sequence.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification factor of prior biological DMARD use|Response Rate Difference = Upadacitinib - Adalimumab|||16.1|5.3|<0.001
72613891|NCT02629159|144757245|SUPERIORITY|In order to preserve Type I error, a step-down approach was used to test the primary and ranked key secondary endpoints in a pre-specified order where statistical significance at the 0.05 level could be claimed for a lower ranked endpoint only if the previous endpoint in the sequence met the requirements of significance.|LS Mean Difference|-1.33|||<|0.001|TWO_SIDED|95.0|-1.469|-1.194||This comparison was a ranked key secondary endpoint in the pre-specified multiplicity testing sequence for US/FDA and EU/EMA.|ANCOVA|Analysis of covariance (ANCOVA) model with treatment, prior biological DMARD use, and Baseline value as covariates.|Treatment Difference = Upadacitinib - Placebo|||-1.194|-1.469|<0.001
72613892|NCT02629159|144757245|SUPERIORITY||LS Mean Difference|-0.47|||<|0.001|TWO_SIDED|95.0|-0.638|-0.295||This comparison was not part of the pre-specified multiplicity testing sequence.|ANCOVA|ANCOVA model with treatment, prior biological DMARD use and Baseline value as covariates.|Treatment Difference = Upadacitinib - Adalimumab|||-0.295|-0.638|<0.001
72613893|NCT02629159|144757246|SUPERIORITY|In order to preserve Type I error, a step-down approach was used to test the primary and ranked key secondary endpoints in a pre-specified order where statistical significance at the 0.05 level could be claimed for a lower ranked endpoint only if the previous endpoint in the sequence met the requirements of significance.|LS Mean Difference|-0.67|||<|0.001|TWO_SIDED|95.0|-0.97|-0.37||This comparison was a ranked key secondary endpoint in the pre-specified multiplicity testing sequence for US/FDA and EU/EMA.|ANCOVA|ANCOVA model with treatment, prior biological DMARD use and Baseline value as covariates.|Treatment Difference = Upadacitinib - Placebo|||-0.37|-0.97|<0.001
72613894|NCT02629159|144757246|SUPERIORITY||LS Mean Difference|0.14||||0.448|TWO_SIDED|95.0|-0.23|0.51||This comparison was not part of the pre-specified multiplicity testing sequence.|ANCOVA|ANCOVA model with treatment, prior biological DMARD use and Baseline value as covariates.|Treatment Difference = Upadacitinib - Adalimumab|||0.51|-0.23|0.448
72327385|NCT02831855|144178316|SUPERIORITY||Difference in percentage of participants|-10.02|STANDARD_ERROR_OF_MEAN|3.87|||TWO_SIDED|95.0|-17.61|-2.42||||||Week 36||-2.42|-17.61|
72327386|NCT02831855|144178316|SUPERIORITY||Difference in percentage of participants|-6.62|STANDARD_ERROR_OF_MEAN|3.89|||TWO_SIDED|95.0|-14.26|1.0||||||Week 48||1.00|-14.26|
72613895|NCT02629159|144757247|SUPERIORITY|In order to preserve Type I error, a step-down approach was used to test the primary and ranked key secondary endpoints in a pre-specified order where statistical significance at the 0.05 level could be claimed for a lower ranked endpoint only if the previous endpoint in the sequence met the requirements of significance.|LS Mean Difference|-0.31|||<|0.001|TWO_SIDED|95.0|-0.372|-0.253||This comparison was a ranked key secondary endpoint in the pre-specified multiplicity testing sequence for US/FDA and EU/EMA.|ANCOVA|ANCOVA model with treatment, prior biological DMARD use and Baseline value as covariates.|Treatment Difference = Upadacitinib - Placebo|||-0.253|-0.372|<0.001
72419701|NCT00409682|144350488|SUPERIORITY_OR_OTHER||Mean Difference (Net)|10.72||||0.073|TWO_SIDED|95.0|-3.45|24.89||The hierarchical stepwise closed testing procedure was implemented to control the overall significance level at 0.05 in the ITT population|Cochran-Mantel-Haenszel||A significance test for any individual major secondary efficacy endpoint in the hierarchy was to be inferential only if the hypothesis tests of all preceding major secondary efficacy endpoints were statistically significant at 0.050.|The point estimates for the number of subjects who achieved PCDAI clinical response in each treatment group and the difference in number between the groups were provided. The P value and 95% confidence intervals (CIs) for the difference were provided. The analysis was performed for the intent-to-treat (ITT) population using the non-responder imputation (NRI) method.||24.89|-3.45|0.073
72419702|NCT00409682|144350489|SUPERIORITY_OR_OTHER||Mean Difference (Net)|13.51||||0.038|TWO_SIDED|95.0|-0.01|27.04||The hierarchical stepwise closed testing procedure was implemented to control the overall significance level at 0.05 in the ITT population|Cochran-Mantel-Haenszel||A significance test for any individual major secondary efficacy endpoint in the hierarchy was to be inferential only if the hypothesis tests of all preceding major secondary efficacy endpoints were statistically significant at 0.050.|The point estimates for the number of subjects who achieved PCDAI clinical response in each treatment group and the difference in number between the groups were provided. The P value and 95% confidence intervals (CIs) for the difference were provided. The analysis was performed for the intent-to-treat (ITT) population using the non-responder imputation (NRI) method.||27.04|-0.01|0.038
72419703|NCT00409682|144350490|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.1|STANDARD_ERROR_OF_MEAN|2.903||0.161|TWO_SIDED|95.0|-9.86|1.66||The hierarchical stepwise closed testing procedure was implemented to control the overall significance level at 0.05 in the ITT population.|ANCOVA||Difference is between adalimumab High-dose and adalimumab Low-dose groups. Baseline means include subjects who had both Baseline and post-Baseline measurements.|"Analyzed as change from Baseline to Week 26, and compared between the two treatment groups. The estimated treatment mean difference, P values, and 95% CI for the treatment difference were provided. Analysis was conducted in the ITT population for OC.~The P value is from the ANCOVA model with treatment as a factor, adjusted for the baseline value, and the strata (response status at Week 4 and prior infliximab experience)."||1.66|-9.86|0.161
72419704|NCT00409682|144350491|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.0|STANDARD_ERROR_OF_MEAN|2.941||0.735|TWO_SIDED|95.0|-6.88|4.88|||ANCOVA||Difference is between adalimumab High-dose and adalimumab Low-dose groups. Baseline means include subjects who had both Baseline and post-Baseline measurements.|Analyzed as change from Baseline to Week 52, and compared between the two treatment groups. The estimated treatment mean difference, P values, and 95% confidence interval (CI) for the treatment difference were provided. Analysis was conducted in the ITT population for OC.||4.88|-6.88|0.735
72419705|NCT00834106|144350516|SUPERIORITY_OR_OTHER||Vaccine efficacy|76.0|||||TWO_SIDED|95.0|43.7|91.1|||||Vaccine efficacy = 100 \* \[1 - (incidence rate with V501 / incidence rate with placebo)\]. The pre-specified success criterion was that the lower bound of the 95% confidence interval for vaccine efficacy excludes 0%.|||91.1|43.7|
72419706|NCT00834106|144350517|SUPERIORITY_OR_OTHER||Vaccine efficacy|82.3|||||TWO_SIDED|95.0|38.3|96.7|||||Vaccine efficacy = 100 \* \[1 - (incidence rate with V501 / incidence rate with placebo)\]. The pre-specified success criterion was that the lower bound of the 95% confidence interval for vaccine efficacy excludes 0%.|||96.7|38.3|
72419707|NCT00834106|144350518|SUPERIORITY_OR_OTHER||Vaccine efficacy|100.0||||0.0072|TWO_SIDED|95.0|32.3|100.0|||Exact test, 1-sided||Vaccine efficacy = 100 \* \[1 - (incidence rate with V501 / incidence rate with placebo)\]. The pre-specified success criterion was that the lower bound of the 95% confidence interval for vaccine efficacy excludes 0%.|||100|32.3|0.0072
72419708|NCT00834106|144350524|SUPERIORITY_OR_OTHER||Vaccine efficacy|91.8|||||TWO_SIDED|95.0|79.8|97.4|||||Vaccine efficacy = 100 \* \[1 - (incidence rate with V501 / incidence rate with placebo)\].|||97.4|79.8|
72419709|NCT00834106|144350525|SUPERIORITY_OR_OTHER||Vaccine efficacy|93.2|||||TWO_SIDED|95.0|72.9|99.2|||||Vaccine efficacy = 100 \* \[1 - (incidence rate with V501 / incidence rate with placebo)\].|||99.2|72.9|
72419710|NCT00118716|144350532|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.0|STANDARD_ERROR_OF_MEAN|1.29||0.021|TWO_SIDED|95.0|0.5|5.6||LS Mean Difference, SE, CI, and p-value were from an ANCOVA model with terms for treatment, investigator, age stratum, and baseline value.|ANCOVA||LS Mean Diff was calculated as FSC 100/50mcg BID-FP 100mcg BID.|FSC 100/50mcg BID versus FP 100mcg BID for maximal percent change in FEV1 following exercise challenge at Week 4.||5.6|0.5|0.021
72419711|NCT00118716|144350533|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.41|STANDARD_ERROR_OF_MEAN|0.085|<|0.001|TWO_SIDED|95.0|0.24|0.58||LS Mean Diff, SE, CI, and p-value were from an ANCOVA model with terms for treatment, investigator, age stratum, and baseline value.|ANCOVA||LS Mean Diff was calculated as FSC 100/50mcg BID-FP 100mcg BID.|FSC 100/50mcg BID versus FP 100mcg BID for post-dose FEV1 AUC Day 1.||0.58|0.24|<0.001
72419712|NCT00118716|144350534|SUPERIORITY_OR_OTHER||Mean Difference (Net)|8.1|STANDARD_ERROR_OF_MEAN|4.83||0.097|TWO_SIDED|95.0|-1.5|17.6||LS Mean Diff, SE, CI, and p-values were from an ANCOVA model with terms for treatment, investigator, age stratum, and baseline value.|ANCOVA||LS Mean Diffs were calculated as FSC 100/50mcg BID-FP 100mcg BID.|FSC 100/50mcg BID versus FP 100mcg BID for AM PEF||17.6|-1.5|0.097
72419713|NCT00118716|144350535|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.7|STANDARD_ERROR_OF_MEAN|4.3||0.396|TWO_SIDED|95.0|-4.8|12.1||LS Mean Diff, SE, CI, and p-values were from an ANCOVA model with terms for treatment, investigator, age stratum, and baseline value.|ANCOVA||LS Mean Diffs were calculated as FSC 100/50mcg BID-FP 100mcg BID.|FSC 100/50mcg BID versus FP 100mcg BID PM PEF.||12.1|-4.8|0.396
72419714|NCT00118716|144350538|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.18|STANDARD_ERROR_OF_MEAN|0.129||0.168|TWO_SIDED|95.0|-0.08|0.43||LS Mean Diff, SE, CI, and p-values were from an ANCOVA model with terms for treatment, investigator, age stratum, and baseline value.|ANCOVA|||FSC 100/50mcg BID versus FP 100mcg BID for activity limitation at Week 2||0.43|-0.08|0.168
72419715|NCT00118716|144350538|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.11|STANDARD_ERROR_OF_MEAN|0.147||0.465|TWO_SIDED|95.0|-0.18|0.4||LS Mean Diff, SE, CI, and p-values were from an ANCOVA model with terms for treatment, investigator, age stratum, and baseline value.|ANCOVA|||FSC 100/50mcg BID versus FP 100mcg BID for activity limitation at Week 4.||0.40|-0.18|0.465
72419716|NCT00118716|144350538|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.16|STANDARD_ERROR_OF_MEAN|0.133||0.222|TWO_SIDED|95.0|-0.1|0.42||LS Mean Diff, SE, CI, and p-values are from an ANCOVA model with terms for treatment, investigator, age stratum, and baseline value.|ANCOVA|||FSC 100/50mcg BID versus FP 100mcg BID for activity limitation at Endpoint.||0.42|-0.10|0.222
72419717|NCT00118716|144350538|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1|STANDARD_ERROR_OF_MEAN|0.096||0.294|TWO_SIDED|95.0|-0.29|0.09||LS Mean Diff, SE, CI, and p-values were from an ANCOVA model with terms for treatment, investigator, age stratum, and baseline value.|ANCOVA|||FSC 100/50mcg BID versus FP 100mcg BID for emotional function at Week 2.||0.09|-0.29|0.294
72419718|NCT00118716|144350538|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.02|STANDARD_ERROR_OF_MEAN|0.111||0.828|TWO_SIDED|95.0|-0.24|0.19||LS Mean Diff, SE, CI, and p-values were from an ANCOVA model with terms for treatment, investigator, age stratum, and baseline value.|ANCOVA|||FSC 100/50mcg BID versus FP 100mcg BID for emotional function at Week 4.||0.19|-0.24|0.828
72419719|NCT00118716|144350538|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.01|STANDARD_ERROR_OF_MEAN|0.103||0.903|TWO_SIDED|95.0|-0.19|0.22||LS Mean Diff, SE, CI, and p-values were from an ANCOVA model with terms for treatment, investigator, age stratum, and baseline value.|ANCOVA|||FSC 100/50mcg BID versus FP 100mcg BID for emotional function at Endpoint.||0.22|-0.19|0.903
72419720|NCT00118716|144350538|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.08|STANDARD_ERROR_OF_MEAN|0.112||0.464|TWO_SIDED|95.0|-0.3|0.14|||ANCOVA|LS Mean Diff, SE, CI, and p-values were from an ANCOVA model with terms for treatment, investigator, age stratum, and baseline value.||FSC 100/50mcg BID versus FP 100mcg BID for symptoms at Week 2.||0.14|-0.30|0.464
72419721|NCT00118716|144350538|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.07|STANDARD_ERROR_OF_MEAN|0.124||0.551|TWO_SIDED|95.0|-0.32|0.17||LS Mean Diff, SE, CI, and p-values were from an ANCOVA model with terms for treatment, investigator, age stratum, and baseline value.|ANCOVA|||FSC 100/50mcg BID versus FP 100mcg BID for symptoms at Week 4.||0.17|-0.32|0.551
72327387|NCT01803880|144178328|NON_INFERIORITY|"Non-inferiority Margin = 10 points. Non-inferiority of study device was concluded if lower limit of one-sided 97.5% CI for treatment difference \<10.~Superiority of study device was established if LS means of treatment difference and lower limit of one-sided 97.5% CI for treatment difference ≤0."|One-sided 97.5% confidence interval (CI)|-7.42|STANDARD_ERROR_OF_MEAN|5.137|>|0.05|ONE_SIDED|97.5|-19.29|||All unscheduled visits were to be included and nominal visits were to be applied using analysis visit windows. Both the assigned analysis visits and the site reported nominal visits were provided in the subject data listings.|ANCOVA|Due to early termination, all inferential analysis was interpreted as descriptive and carried out in an exploratory manner.||An ANCOVA model was used to compare the difference in the devices for change from Baseline in the KOOS at Week 52. KOOS was derived as the average of five subscale scores. LOCF imputation was considered for missing value. One-sided 97.5% confidence interval (CI) for treatment difference (Study-Control) was to be used for determining non-inferiority/superiority of the study device.|||-19.29|>0.05
72327388|NCT04229888|144178374|NON_INFERIORITY|To establish non-inferiority of the treatment effect on the primary outcome change in DEQ-5 score, the upper bound of the two-sided 95% confidence interval on mean difference between the light based (sham) treatment and Lipiflow treatment were compared against a non-inferiority margin M=6 representing the largest clinically acceptable difference based on historical data.||||||0.02|||||||ANOVA|||||||0.02
72327389|NCT04229888|144178375|NON_INFERIORITY|To establish non-inferiority of the treatment effect on the primary outcome change in MG score, the upper bound of the two-sided 95% confidence interval on mean difference between the light based (sham) treatment and Lipiflow treatment were compared against a non-inferiority margin M= 1 representing the largest clinically acceptable difference based on historical data.||||||0.07|||||||ANOVA|||||||0.07
72327390|NCT04229888|144178376|NON_INFERIORITY|To establish non-inferiority of the treatment effect on the primary outcome change in TBUT, the upper bound of the two-sided 95% confidence interval on mean difference between the light based (sham) treatment and Lipiflow treatment were compared against a non-inferiority margin M=6 representing the largest clinically acceptable difference based on historical data.||||||0.66|||||||ANOVA|||||||0.66
72327391|NCT01299389|144178381|SUPERIORITY_OR_OTHER||Least squares (LS) means difference|-9.7|STANDARD_ERROR_OF_MEAN|2.19|<|0.0001|TWO_SIDED|95.0|-14.0|-5.4|||ANCOVA|||Change at Week 13 or Early Discontinuation: P value were calculated using an analysis of covariance (ANCOVA) model with treatment and country as factors and baseline PANSS total score as a covariate.||-5.4|-14.0|<0.0001
72419722|NCT00118716|144350538|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.06|STANDARD_ERROR_OF_MEAN|0.123||0.633|TWO_SIDED|95.0|-0.3|0.18||LS Mean Diff, SE, CI, and p-values were from an ANCOVA model with terms for treatment, investigator, age stratum, and baseline value.|ANCOVA|||FSC 100/50mcg BID versus FP 100mcg BID for symptoms at Endpoint.||0.18|-0.30|0.633
72419723|NCT00118716|144350538|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.04|STANDARD_ERROR_OF_MEAN|0.094||0.7|TWO_SIDED|95.0|-0.22|0.15||LS Mean Diff, SE, CI, and p-values are from an ANCOVA model with terms for treatment, investigator, age stratum, and baseline value.|ANCOVA|||FSC 100/50mcg BID versus FP 100mcg BID for overall score at Week 2.||0.15|-0.22|0.700
72419724|NCT00118716|144350538|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.02|STANDARD_ERROR_OF_MEAN|0.109||0.86|TWO_SIDED|95.0|-0.23|0.2||LS Mean Diff, SE, CI, and p-values were from an ANCOVA model with terms for treatment, investigator, age stratum, and baseline value.|ANCOVA|||FSC 100/50mcg BID versus FP 100mcg BID for overall score at Week 4.||0.20|-0.23|0.860
72419725|NCT00118716|144350538|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.01|STANDARD_ERROR_OF_MEAN|0.103||0.919|TWO_SIDED|95.0|-0.19|0.21||LS Mean Diff, SE, CI, and p-values were from an ANCOVA model with terms for treatment, investigator, age stratum, and baseline value.|ANCOVA|||FSC 100/50mcg BID versus FP 100mcg BID for overall score at Endpoint.||0.21|-0.19|0.919
72327392|NCT01299389|144178384|SUPERIORITY_OR_OTHER||LS Mean difference|-2.7|STANDARD_ERROR_OF_MEAN|0.69|<|0.0001|TWO_SIDED|95.0|-4.1|-1.4|||ANCOVA|||Positive symptoms (change at Week 13 or ED): P value was calculated using an ANCOVA model with treatment and country as factors and baseline PANSS factor scores as covariates.||-1.4|-4.1|<0.0001
72327393|NCT01299389|144178384|SUPERIORITY_OR_OTHER||LS Mean difference|-2.0|STANDARD_ERROR_OF_MEAN|0.61||0.0012|TWO_SIDED|95.0|-3.2|-0.8|||ANCOVA|||Negative symptoms (change at Week 13 or ED): P value was calculated using an ANCOVA model with treatment and country as factors and baseline PANSS factor scores as covariates.||-0.8|-3.2|0.0012
72327394|NCT01299389|144178384|SUPERIORITY_OR_OTHER||LS Mean difference|-2.2|STANDARD_ERROR_OF_MEAN|0.57|<|0.0001|TWO_SIDED|95.0|-3.4|-1.1|||ANCOVA|||Disorganized thoughts (change at Week 13 or ED): P value was calculated using an ANCOVA model with treatment and country as factors and baseline PANSS factor scores as covariates.||-1.1|-3.4|<0.0001
72327395|NCT01299389|144178384|SUPERIORITY_OR_OTHER||LS Mean difference|-1.4|STANDARD_ERROR_OF_MEAN|0.45||0.0023|TWO_SIDED|95.0|-2.3|-0.5|||ANCOVA|||Uncontrolled hostility/excitement (change at Week 13 or ED): P value was calculated using an ANCOVA model with treatment and country as factors and baseline PANSS factor scores as covariates.||-0.5|-2.3|0.0023
72327396|NCT01299389|144178384|SUPERIORITY_OR_OTHER||LS Mean difference|-1.1|STANDARD_ERROR_OF_MEAN|0.37||0.0025|TWO_SIDED|95.0|-1.9|-0.4|||ANCOVA|||Anxiety/depression (change at Week 13 or ED): P value was calculated using an ANCOVA model with treatment and country as factors and baseline PANSS factor scores as covariates.||-0.4|-1.9|0.0025
72327397|NCT01299389|144178385|SUPERIORITY_OR_OTHER||LS Mean difference|-2.1|STANDARD_ERROR_OF_MEAN|0.59||0.0003|TWO_SIDED|95.0|-3.3|-1.0|||ANCOVA|||Change at Week 13 or Early Discontinuation: P value were calculated using an ANCOVA model with treatment and country as factors and baseline PANSS total score as a covariate.||-1.0|-3.3|0.0003
72327398|NCT01299389|144178386|SUPERIORITY_OR_OTHER||LS Mean difference|-2.8|STANDARD_ERROR_OF_MEAN|0.67|<|0.0001|TWO_SIDED|95.0|-4.1|-1.5|||ANCOVA|||Change at Week 13 or Early Discontinuation: P value were calculated using an ANCOVA model with treatment and country as factors and baseline PANSS total score as a covariate.||-1.5|-4.1|<0.0001
72327399|NCT01299389|144178387|SUPERIORITY_OR_OTHER||LS Mean difference|-4.6|STANDARD_ERROR_OF_MEAN|1.17|<|0.0001|TWO_SIDED|95.0|-6.9|-2.3|||ANCOVA|||Change at Week 13 or Early Discontinuation: P value were calculated using an ANCOVA model with treatment and country as factors and baseline PANSS total score as a covariate.||-2.3|-6.9|<0.0001
72327400|NCT01151020|144178391|SUPERIORITY_OR_OTHER_LEGACY||Free from major adverse event rate (%)|96.4|||<|0.001|TWO_SIDED|95.0|91.0|99.0|||Exact binomial test|||Null hypothesis: The 30-day freedom from MAE for patients treated with the Zenith® TX2® Low Profile TAA Endovascular Graft does not meet the performance goal of 80.6%.||99|91|< 0.001
72327401|NCT01151020|144178392|SUPERIORITY_OR_OTHER_LEGACY||Device success rate (%)|92.7|||<|0.001|TWO_SIDED|95.0|86.2|96.8|||Exact binomial test|||Null Hypothesis: The 12-month device success for patients treated with the Zenith® TX2® Low Profile TAA Endovascular Graft does not meet the performance goal of 80.7%.||96.8|86.2|< 0.001
72419726|NCT02436811|144350541|SUPERIORITY_OR_OTHER||||||<|0.001||||||A stepwise forward selection model was used. All independent variables with P\<0.20 in the univariate analysis were selected and those which were significant (P\<0.05) were kept in the final model. The level of significance was 5%.|Regression, Poisson|||Univariate and multivariate Poisson regressions with robust variance were obtained to estimate the rate ratios (RR) and their respective 95% confidence intervals. Two Poisson regression models were generated, using the knowledge score 15 minutes after the intervention (post-test) and 4 weeks after the interventions (follow-up test) as dependent variables.||||<0.001
72613896|NCT02629159|144757247|SUPERIORITY|In order to preserve Type I error, a step-down approach was used to test the primary and ranked key secondary endpoints in a pre-specified order where statistical significance at the 0.05 level could be claimed for a lower ranked endpoint only if the previous endpoint in the sequence met the requirements of significance.|LS Mean Difference|-0.11||||0.004|TWO_SIDED|95.0|-0.184|-0.036||This comparison was a ranked key secondary endpoint in the pre-specified multiplicity testing sequence for US/FDA only.|ANCOVA|ANCOVA model with treatment, prior biological DMARD use and Baseline value as covariates.|Treatment Difference = Upadacitinib - Adalimumab|||-0.036|-0.184|0.004
72327402|NCT00149799|144178411|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.73||||0.048|TWO_SIDED|95.0|1.01|8.59|||Regression, Cox|p-value is based on the likelihood ratio Chi-Square statistic.||Cox proportional hazards regression was used to compare relapse rates (accounting for censoring and time from randomization to relapse) in Phase II.||8.59|1.01|0.048
72327403|NCT00149799|144178413|SUPERIORITY||Slope difference|-0.07006|STANDARD_ERROR_OF_MEAN|0.04163||0.093|TWO_SIDED|||||A priori threshold for statistical significance: 0.0167 Model term of interest: treatment by time interaction (i.e., slope difference between treatments over time)|Mixed Models Analysis|Degrees of freedom=556||"We compared change in depression over time by randomized treatment group (Escitalopram vs. Placebo) using a random coefficient model that included terms for treatment group, time, site, and all their interactions, modeling intercepts and slopes as random effects per person.~Null hypothesis: The rate of change in depression symptom severity in the Escitalopram group will not be significantly different from the placebo group \[to be tested\]."||||0.0930
72419727|NCT02227875|144350542|NON_INFERIORITY|Mixed-Effect Model for Repeated Measures|Mean Difference (Net)|0.06|STANDARD_ERROR_OF_MEAN|0.08|||TWO_SIDED|95.0|-0.098|0.218||||||||0.218|-0.098|
72419728|NCT00406133|144350640|SUPERIORITY_OR_OTHER|||||||0.29||||||"A P value of 0.0167 was considered the significance level for the primary analysis in each age group to maintain an overall type I error rate of 0.05.~P value is for age 8-14 group."|ANCOVA|Performed in each age group and adjusted for the baseline A1c and clinical center.||The study was to test whether the use of CGM will lower A1c at 26 weeks. The estimated sample size was 110 for each age group, which will provide 90% power to detect a difference between treatment groups in each of the age groups assuming a population difference of 0.5%, a two-tailed test with type I error rate of 5%, standard deviation of the 6 month HbA1c values of 0.9, correlation between baseline and 26-week values of 0.58.||||0.29
72419729|NCT00406133|144350640|SUPERIORITY_OR_OTHER|||||||0.52||||||"A P value of 0.0167 was considered the significance level for the primary analysis in each age group to maintain an overall type I error rate of 0.05.~P value for age 15-24 group."|ANCOVA|Performed in each age group and adjusted for the baseline A1c and clinical center.||||||0.52
72419730|NCT00406133|144350640|SUPERIORITY_OR_OTHER||||||<|0.001||||||"A P value of 0.0167 was considered the significance level for the primary analysis in each age group to maintain an overall type I error rate of 0.05.~P value is for age \>=25 group."|ANCOVA|Performed in each age group and adjusted for the baseline A1c and clinical center.||||||<0.001
72419731|NCT00406133|144350641|SUPERIORITY_OR_OTHER|||||||0.16||||||P-value was for the comparison of RT-CGM group and Control group.|ANCOVA|Based on the ranks of the 26wk values using VDW scores, adjusted for the baseline value, clinical center, and type of continuous glucose monitor.||A sample size of 120 subjects was planned to have 90% power to detect a difference in this outcome between treatment groups, assuming a population difference of 29 min/day, standard deviation of the 26-week values of 59 min/day, correlation between baseline and 26-week values of 0.66, an α=0.05, and no more than 15% losses to follow-up.||||0.16
72419732|NCT00406133|144350642|SUPERIORITY_OR_OTHER|||||||0.74||||||P-value is for N(%) of subjects with \>=1 severe hypo event in the 8-14 year age group.|Fisher Exact|||The proportions of patients experiencing one or more severe hypoglycemic events in each treatment group were compared using Fisher's exact test. Incidences of hypoglycemic events were compared and confidence intervals for the treatment group difference calculated using permutation tests. Similar analyses were performed for the subset of hypoglycemic events associated with seizure or coma.||||0.74
72419733|NCT00406133|144350642|SUPERIORITY_OR_OTHER|||||||0.48||||||P-value is for N(%) of subjects with \>=1 severe hypo event in the 15-24 year age group.|Fisher Exact|||||||0.48
72419734|NCT00406133|144350642|SUPERIORITY_OR_OTHER|||||||1||||||P-value is for N(%) of subjects with \>=1 severe hypo event in the \>=25 year age group.|Fisher Exact|||||||1.0
72419735|NCT00406133|144350642|SUPERIORITY_OR_OTHER|||||||0.74|TWO_SIDED|95.0||||P-value is for N(%) of subjects with \>=1 severe hypo event with seizure or comma in the 8-14 year age group.|Fisher Exact|||The proportions of patients experiencing one or more severe hypoglycemic events in each treatment group were compared using Fisher's exact test. Incidences of hypoglycemic events were compared and confidence intervals for the treatment group difference calculated using permutation tests. Similar analyses were performed for the subset of hypoglycemic events associated with seizure or coma.||||0.74
72419736|NCT00406133|144350642|SUPERIORITY_OR_OTHER|||||||0.48|TWO_SIDED|95.0||||P-value is for N(%) of subjects with \>=1 severe hypo event with seizure or comma in the 15-24 year age group.|Fisher Exact|||The proportions of patients experiencing one or more severe hypoglycemic events in each treatment group were compared using Fisher's exact test. Incidences of hypoglycemic events were compared and confidence intervals for the treatment group difference calculated using permutation tests. Similar analyses were performed for the subset of hypoglycemic events associated with seizure or coma.||||0.48
72613897|NCT02629159|144757248|NON_INFERIORITY|A non-inferiority test of upadacitinib versus adalimumab was evaluated using the lower bound of the 95% confidence interval (CI) of the treatment difference against a non-inferiority margin of 10%. This comparison was a ranked key secondary endpoint in the pre-specified multiplicity testing sequence for US/FDA only.|Response Rate Difference|16.1|||||TWO_SIDED|95.0|9.9|22.3|||||Response Rate Difference = Upadacitinib - Adalimumab|||22.3|9.9|
72419737|NCT00406133|144350642|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED|95.0||||P-value is for N(%) of subjects with \>=1 severe hypo event with seizure or comma in the \>=25 year age group.|Fisher Exact|||The proportions of patients experiencing one or more severe hypoglycemic events in each treatment group were compared using Fisher's exact test. Incidences of hypoglycemic events were compared and confidence intervals for the treatment group difference calculated using permutation tests. Similar analyses were performed for the subset of hypoglycemic events associated with seizure or coma.||||1.0
72613898|NCT02629159|144757248|SUPERIORITY|In order to preserve Type I error, a step-down approach was used to test the primary and ranked key secondary endpoints in a pre-specified order where statistical significance at the 0.05 level could be claimed for a lower ranked endpoint only if the previous endpoint in the sequence met the requirements of significance.|||||<|0.001||||||This comparison was a ranked key secondary endpoint in the pre-specified multiplicity testing sequence for US/FDA only.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification factor of prior biological DMARD use.||||||<0.001
72613899|NCT02629159|144757248|SUPERIORITY||Response Rate Difference|30.3|||<|0.001|TWO_SIDED|95.0|25.6|35.0||This comparison was not part of the pre-specified multiplicity testing sequence.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification factor of prior biological DMARD use|Response Rate Difference = Upadacitinib - Placebo|||35.0|25.6|<0.001
72613900|NCT02629159|144757249|SUPERIORITY|In order to preserve Type I error, a step-down approach was used to test the primary and ranked key secondary endpoints in a pre-specified order where statistical significance at the 0.05 level could be claimed for a lower ranked endpoint only if the previous endpoint in the sequence met the requirements of significance.|LS Mean Difference|4.33|||<|0.001|TWO_SIDED|95.0|3.52|5.15||This comparison was a ranked key secondary endpoint in the pre-specified multiplicity testing sequence for US/FDA and EU/EMA.|Mixed Effect Model Repeat Measurement|MMRM model with fixed effects of treatment, visit, and treatment-by-visit interaction, previous bDMARD use, and Baseline value as covariate.|Treatment Difference = Upadacitinib - Placebo|||5.15|3.52|<0.001
72613901|NCT02629159|144757249|SUPERIORITY||LS Mean Difference|1.62||||0.002|TWO_SIDED|95.0|0.62|2.62||This comparison was not part of the pre-specified multiplicity testing sequence.|Mixed Effect Model Repeat Measurement|MMRM model with fixed effects of treatment, visit, and treatment-by-visit interaction, previous bDMARD use, and Baseline value as covariate.|Treatment Difference = Upadacitinib - Adalimumab|||2.62|0.62|0.002
72613902|NCT02629159|144757250|SUPERIORITY|In order to preserve Type I error, a step-down approach was used to test the primary and ranked key secondary endpoints in a pre-specified order where statistical significance at the 0.05 level could be claimed for a lower ranked endpoint only if the previous endpoint in the sequence met the requirements of significance.|Response Rate Difference|31.2|||<|0.001|TWO_SIDED|95.0|26.5|35.8||This comparison was a ranked key secondary endpoint in the pre-specified multiplicity testing sequence for US/FDA and EU/EMA.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification factor of prior biological DMARD use|Response Rate Difference = Upadacitinib - Placebo|||35.8|26.5|<0.001
72613903|NCT02629159|144757250|NON_INFERIORITY|A non-inferiority test of upadacitinib versus adalimumab was evaluated using the lower bound of the 95% confidence interval (CI) of the treatment difference against a non-inferiority margin of 10%. This comparison was a ranked key secondary endpoint in the pre-specified multiplicity testing sequence for EU/EMA only.|Response Rate Difference|16.3|||||TWO_SIDED|95.0|10.0|22.5|||||Response Rate Difference = Upadacitinib - Adalimumab|||22.5|10.0|
72613904|NCT02629159|144757250|SUPERIORITY||||||<|0.001||||||This comparison was not part of the pre-specified multiplicity testing sequence.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification factor of prior biological DMARD use||||||<0.001
72613905|NCT02629159|144757251|SUPERIORITY|In order to preserve Type I error, a step-down approach was used to test the primary and ranked key secondary endpoints in a pre-specified order where statistical significance at the 0.05 level could be claimed for a lower ranked endpoint only if the previous endpoint in the sequence met the requirements of significance.|Response Rate Difference|24.1|||<|0.001|TWO_SIDED|95.0|19.4|28.8||This comparison was a ranked key secondary endpoint in the pre-specified multiplicity testing sequence for US/FDA and EU/EMA.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification factor of prior biological DMARD use.|Response Rate Difference = Upadacitinib - Placebo|||28.8|19.4|<0.001
72613906|NCT02629159|144757251|SUPERIORITY||Response Rate Difference|10.4||||0.001|TWO_SIDED|95.0|4.2|16.7||This comparison was not part of the pre-specified multiplicity testing sequence.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification factor of prior biological DMARD use|Response Rate Difference = Upadacitinib - Adalimumab|||16.7|4.2|0.001
72613907|NCT02629159|144757252|SUPERIORITY|In order to preserve Type I error, a step-down approach was used to test the primary and ranked key secondary endpoints in a pre-specified order where statistical significance at the 0.05 level could be claimed for a lower ranked endpoint only if the previous endpoint in the sequence met the requirements of significance.|LS Mean Difference|-44.04|||<|0.001|TWO_SIDED|95.0|-55.39|-32.69||This comparison was a ranked key secondary endpoint in the pre-specified multiplicity testing sequence for US/FDA and EU/EMA.|Mixed Effect Model Repeat Measurement|MMRM model with fixed effects of treatment, visit, and treatment-by-visit interaction, previous bDMARD use, and Baseline value as covariate.|Treatment Difference = Upadacitinib - Placebo|||-32.69|-55.39|<0.001
72613908|NCT02629159|144757252|SUPERIORITY||LS Mean Difference|-9.92||||0.164|TWO_SIDED|95.0|-23.89|4.05||This comparison was not part of the pre-specified multiplicity testing sequence.|Mixed Effect Model Repeat Measurement|MMRM model with fixed effects of treatment, visit, and treatment-by-visit interaction, previous bDMARD use, and Baseline value as covariate.|Treatment Difference = Upadacitinib - Adalimumab|||4.05|-23.89|0.164
72613909|NCT02629159|144757253|SUPERIORITY|In order to preserve Type I error, a step-down approach was used to test the primary and ranked key secondary endpoints in a pre-specified order where statistical significance at the 0.05 level could be claimed for a lower ranked endpoint only if the previous endpoint in the sequence met the requirements of significance.|LS Mean Difference|4.15|||<|0.001|TWO_SIDED|95.0|3.13|5.16||This comparison was a ranked key secondary endpoint in the pre-specified multiplicity testing sequence for US/FDA and EU/EMA.|Mixed Effect Model Repeat Measurement|MMRM model with fixed effects of treatment, visit, and treatment-by-visit interaction, previous bDMARD use, and Baseline value as covariate|Treatment Difference = Upadacitinib - Placebo|||5.16|3.13|<0.001
72613910|NCT02629159|144757253|SUPERIORITY||LS Mean Difference|1.51||||0.017|TWO_SIDED|95.0|0.27|2.76||This comparison was not part of the pre-specified multiplicity testing sequence.|Mixed Effect Model Repeat Measurement|MMRM model with fixed effects of treatment, visit, and treatment-by-visit interaction, previous bDMARD use, and Baseline value as covariate.|Treatment Difference = Upadacitinib - Adalimumab|||2.76|0.27|0.017
72613911|NCT02629159|144757254|SUPERIORITY|In order to preserve Type I error, a step-down approach was used to test the primary and ranked key secondary endpoints in a pre-specified order where statistical significance at the 0.05 level could be claimed for a lower ranked endpoint only if the previous endpoint in the sequence met the requirements of significance.|LS Mean Difference|-6.45|||<|0.001|TWO_SIDED|95.0|-9.63|-3.27||This comparison was a ranked key secondary endpoint in the pre-specified multiplicity testing sequence for US/FDA only.|Mixed Effect Model Repeat Measurement|MMRM model with fixed effects of treatment, visit, and treatment-by-visit interaction, previous bDMARD use, and Baseline value as covariate.|Treatment Difference = Upadacitinib - Adalimumab|||-3.27|-9.63|<0.001
72613912|NCT02629159|144757254|SUPERIORITY||LS Mean Difference|-16.3|||<|0.001|TWO_SIDED|95.0|-18.89|-13.71||This comparison was not part of the pre-specified multiplicity testing sequence.|Mixed Effect Model Repeat Measurement|MMRM model with fixed effects of treatment, visit, and treatment-by-visit interaction, previous bDMARD use, and Baseline value as covariate.|Treatment Difference = Upadacitinib - Placebo|||-13.71|-18.89|<0.001
72613913|NCT02629159|144757255|SUPERIORITY|In order to preserve Type I error, a step-down approach was used to test the primary and ranked key secondary endpoints in a pre-specified order where statistical significance at the 0.05 level could be claimed for a lower ranked endpoint only if the previous endpoint in the sequence met the requirements of significance.|Response Rate Difference|7.5|||<|0.001|TWO_SIDED|95.0|3.0|12.1||This comparison was a ranked key secondary endpoint in the pre-specified multiplicity testing sequence for EU/EMA only.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification factor of prior biological DMARD use|Response Rate Difference = Upadacitinib - Placebo|||12.1|3.0|<0.001
72613914|NCT02629159|144757255|SUPERIORITY||Response Rate Difference|-3.4||||0.187|TWO_SIDED|95.0|-8.2|1.5||This comparison was not part of the pre-specified multiplicity testing sequence.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification factor of prior biological DMARD use.|Response Rate Difference = Upadacitinib - Adalimumab|||1.5|-8.2|0.187
72613915|NCT02629159|144757256|SUPERIORITY||Response Rate Difference|20.0|||<|0.001|TWO_SIDED|95.0|16.3|23.7||This comparison was not part of the pre-specified multiplicity testing sequence.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification factor of prior biological DMARD use|Response Rate Difference = Upadacitinib - Placebo|||23.7|16.3|<0.001
72613916|NCT02629159|144757256|SUPERIORITY||Response Rate Difference|11.4|||<|0.001|TWO_SIDED|95.0|6.5|16.4||This comparison was not part of the pre-specified multiplicity testing sequence.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification factor of prior biological DMARD use|Response Rate Difference = Upadacitinib - Adalimumab|||16.4|6.5|<0.001
72613917|NCT03033355|144757273|OTHER|||||||0.0012||||||Threshold for statistical significance used P-value \<0.05|Student t-Test|||Right Cingulate Body||||0.0012
72613918|NCT03033355|144757273|OTHER|||||||0.02||||||Threshold for statistical significance used P-value \<0.05|student t-test|||Left Posterior Cingulate||||0.02
72613919|NCT03033355|144757273|OTHER|||||||0.0015||||||Threshold for statistical significance used P-value \<0.05|student t-test|||Left Anterior Cingulate||||0.0015
72613920|NCT03033355|144757273|OTHER|||||||0.0015||||||Threshold for statistical significance used P-value \<0.05|student t-test|||Right Prefrontal Cortex||||0.0015
72613921|NCT03033355|144757273|OTHER|||||||0.0138||||||Threshold for statistical significance used P-value \<0.05|student t-test|||Left Insula||||0.0138
72613922|NCT03033355|144757273|OTHER|||||||0.049||||||Threshold for statistical significance used P-value \<0.05|student t-test|||Pons Micturition Center||||0.049
72613923|NCT03033355|144757273|OTHER|||||||0.001||||||Threshold for statistical significance used P-value \<0.05|student t-test|||Left Cerebellum||||0.001
72613924|NCT03033355|144757273|OTHER|||||||0.026||||||Threshold for statistical significance used P-value \<0.05|student t-test|||Left Lentiform Nucleus||||0.026
72613925|NCT03033355|144757273|OTHER|||||||0.026||||||Threshold for statistical significance used P-value \<0.05|student t-test|||Right Lentiform Nucleus||||0.026
72613926|NCT03033355|144757273|OTHER|||||||0.015||||||Threshold for statistical significance used P-value \<0.05|student t-test|||Left Amygdala/parahippocampal Gyrus||||0.015
72613927|NCT04717557|144757280|SUPERIORITY|||||||1|||||||Chi-squared|||||||1.0
72613928|NCT04717557|144757280|SUPERIORITY||||||>|0.5||||||Underpowered due to early termination.|Chi-squared, Corrected|||||||>0.5
72613929|NCT04717557|144757281|SUPERIORITY||||||>|0.5||||||Underpowered due to early termination.|Chi-squared, Corrected|||||||>0.5
72613930|NCT04717557|144757282|SUPERIORITY||||||>|0.5||||||Underpowered due to early termination.|Chi-squared, Corrected|||||||>0.5
72613931|NCT04717557|144757283|SUPERIORITY||||||>|0.5||||||Underpowered due to early termination.|t-test, 2 sided|||||||>0.5
72613932|NCT04717557|144757284|SUPERIORITY||||||>|0.5|||||||Cochran-Mantel-Haenszel|||Underpowered - no statistically significant difference.||||>0.5
72613933|NCT04717557|144757285|SUPERIORITY||||||>|0.5||||||Underpowered due to early termination.|Chi-squared, Corrected|||||||>0.5
72613934|NCT04717557|144757286|SUPERIORITY||||||>|0.5||||||Underpowered due to early termination.|Chi-squared, Corrected|||||||>0.5
72613935|NCT04717557|144757287|SUPERIORITY||||||>|0.5||||||Underpowered due to early termination.|Chi-squared, Corrected|||||||>0.5
72613936|NCT04717557|144757288|SUPERIORITY||||||>|0.5||||||Underpowered due to early termination.|Chi-squared, Corrected|||||||>0.5
72613937|NCT02685735|144757353|SUPERIORITY|A likelihood-ratio test for change in pain was conducted for each outcome comparing a model with and without gabapentin treatment group. A statistically significant result is interpreted as evidence to support that the gabapentin treatment impacts some element of change after surgery (i.e, intercept or slope).||||||0.882||||||P value not adjusted for multiple comparisons, with threshold of statistical significance set at \<0.05|Mixed Models Analysis|||The estimates were conducted using a linear mixed effects model contrasting differences in the gabapentin group versus placebo. In all cases, these differences are adjusted for prognostic variables including baseline pain, age, sex, pupil diameter, and catastophizing-optimism construct.||||0.882
72613938|NCT02685735|144757359|SUPERIORITY|A likelihood-ratio test for change in pain was conducted for each outcome comparing a model with and without gabapentin treatment group. A statistically significant result is interpreted as evidence to support that the gabapentin treatment impacts some element of change after surgery (i.e, intercept or slope).||||||0.137||||||P value not adjusted for multiple comparisons, with threshold of statistical significance set at \<0.05|Mixed Models Analysis|||The estimates were conducted using a linear mixed effects model contrasting differences in the gabapentin group versus placebo. In all cases, these differences are adjusted for prognostic variables including baseline pain, age, sex, pupil diameter, and catastrophizing-optimism construct.||||0.137
72613939|NCT02685735|144757360|SUPERIORITY||||||<|0.0001|||||||Chi-squared|14 degrees of freedom||The null hypothesis (H0) is that modeled trajectory of change in pain intensity report after total hip or total knee arthroplasty does not differ between oral gabapentin and placebo in a manner dependent on its interaction with preferred cognitive style and pre-surgery pupil resting diameter . The alternative hypothesis (H1) is that there is a difference between the two groups which is dependent on these interactions.|A likelihood ratio test was conducted to compare these two models, conditional on the difference in the degrees of freedom in both models. A statistically significant likelihood ratio test would be interpreted as evidence that the three mechanistic predictors (Catastrophising-Optimism construct, Study Group, resting Pupil diameter) impact some aspect of the change in pain that occurs after surgery. If a statistically significant effect is observed, the individual interaction parameters will be interpreted.|||<0.0001
72613940|NCT05965427|144757361|SUPERIORITY|||||||0.097|||||||Chi-squared|||||||0.097
72613941|NCT05965427|144757362|SUPERIORITY|||||||0.005|||||||Chi-squared|||"Statistical analysis of Any of the specified clinical complications measure"||||0.005
72327404|NCT00149799|144178414|SUPERIORITY||Slope difference|0.001176|STANDARD_ERROR_OF_MEAN|0.03991||0.9766|TWO_SIDED|||||A priori threshold for statistical significance: 0.0167 Model term of interest: treatment by time interaction (i.e., slope difference between treatments over time)|Mixed Models Analysis|Degrees of freedom=43||"We compared change in functional impairment over time during trial phase 2 by treatment group (Escitalopram vs. Placebo) using a random coefficient model that included terms for treatment group, time, site, and all their interactions, modeling intercepts and slopes as random effects per person.~Null hypothesis: The rate of change in functional impairment in the Escitalopram group will not be significantly different from that of the placebo group \[to be tested\]."||||0.9766
72613942|NCT05965427|144757363|SUPERIORITY|||||||0.011|||||||Chi-squared|||||||0.011
72613943|NCT05965427|144757365|SUPERIORITY|||||||0.002|||||||Chi-squared|||"Statistical analysis relates to not presenting with skin lesions measure"||||0.002
72613944|NCT05965427|144757369|SUPERIORITY|||||||0.114|||||||Chi-squared|||"Statistical analysis relates to any drug treatment for mpox measure"||||0.114
72613945|NCT05965427|144757370|SUPERIORITY||||||<|0.001|||||||Chi-squared|||"Statistical analysis relates to any drug for complications measure"||||<0.001
72613946|NCT05965427|144757371|SUPERIORITY|"Statistical analysis relates to lesion onset measure"|||||<|0.001|||||||Chi-squared|||||||<0.001
72613947|NCT02101788|144757385|SUPERIORITY||Hazard Ratio (HR)|0.55|||||TWO_SIDED|95.0|0.28|1.07|||||Estimation of treatment effect; Trametinib vs. SOC among patients with a mutation.|||1.07|0.28|
72613948|NCT02101788|144757385|SUPERIORITY||Hazard Ratio (HR)|0.64|||||TWO_SIDED|95.0|0.39|1.03|||||Estimation of treatment effect; Trametinib vs. SOC among wild-type patients.|||1.03|0.39|
72613949|NCT02101788|144757385|SUPERIORITY||Hazard Ratio (HR)|0.6||||0.0929|TWO_SIDED|95.0|0.34|1.08|||Chi-squared||Estimation of mutation effect; mutant vs. wild-type in the SOC group.|Prognostic effect of the mutation status among patients in the SOC arm.||1.08|0.34|0.0929
72613950|NCT02101788|144757385|SUPERIORITY|||||||0.7195|||||||Chi-squared|||Predictive effect biomarker p-value||||0.7195
72613951|NCT00927472|144757392|SUPERIORITY_OR_OTHER|||||||0.0386|||||||t-test, 2 sided|||||||0.0386
72613952|NCT00927472|144757393|SUPERIORITY_OR_OTHER|||||||0.3675|||||||t-test, 2 sided|||||||0.3675
72613953|NCT00927472|144757394|SUPERIORITY_OR_OTHER|||||||0.049|||||||t-test, 2 sided|||||||0.0490
72613954|NCT00927472|144757395|SUPERIORITY_OR_OTHER|||||||0.0002|||||||t-test, 2 sided|||||||0.0002
72613955|NCT00927472|144757396|SUPERIORITY_OR_OTHER|||||||0.0003|||||||t-test, 2 sided|||||||0.0003
72613956|NCT00927472|144757397|SUPERIORITY_OR_OTHER|||||||0.0012|||||||t-test, 2 sided|||||||0.0012
72613957|NCT00927472|144757398|SUPERIORITY_OR_OTHER|||||||0.3817|||||||t-test, 2 sided|||||||0.3817
72613958|NCT00927472|144757399|SUPERIORITY_OR_OTHER|||||||0.1059|||||||t-test, 2 sided|||||||0.1059
72613959|NCT00927472|144757400|SUPERIORITY_OR_OTHER|||||||0.1088|||||||t-test, 2 sided|||||||0.1088
72613960|NCT00927472|144757401|SUPERIORITY_OR_OTHER|||||||0.1527|||||||t-test, 2 sided|||||||0.1527
72613961|NCT01081951|144757405|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.51||||0.0012|TWO_SIDED|95.0|0.34|0.77||The use of a one-sided 10% significance level test will be used to assess the statistical significance of the analyses of PFS.|Log Rank|Stratified by number of prior platinum treatment lines (1 or \>1) and time to progression following previous platinum therapy (\>6 to ≤12 vs \>12 months)|A hazard ratio of \< 1 favours olaparib.|The null hypothesis for all efficacy analyses in this study is that there is no difference in treatment effects between olaparib in combination with carboplatin/paclitaxel compared with carboplatin/paclitaxel alone.||0.77|0.34|0.0012
72613962|NCT01081951|144757406|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.17||||0.4379|TWO_SIDED|95.0|0.79|1.73||Two sided|Log Rank|Stratified by number of prior platinum treatment lines (1 or \>1) and time to progression following previous platinum therapy (\>6 to ≤12 vs \>12 months)|A hazard ratio \< 1 favours favours olaparib.|The null hypothesis for all efficacy analyses in this study is that there is no difference in treatment effects between olaparib in combination with carboplatin/paclitaxel compared with carboplatin/paclitaxel alone.||1.73|0.79|0.4379
72613963|NCT03806296|144757424|SUPERIORITY||Mean Difference (Final Values)|-0.42||||0.018|TWO_SIDED|95.0|-0.77|-0.07|||Regression, Linear|||For these Aim 1 analyses comparing the Early/Middle vs Late Sleep groups, the Late Sleep-Control and Late Sleep-Manipulation were combined into a single Late Sleep group. We used a linear regression model to test the effect of group (Early/Mid vs Late) on each a priori outcome, accounting for age and sex.||-0.07|-0.77|0.018
72613964|NCT03806296|144757424|SUPERIORITY||Time X Group interaction|0.67||||0.001|TWO_SIDED|95.0|0.28|1.07|||Mixed Models Analysis|||For Aim 2, this mixed effect model tested the effect of group (Control vs Manipulation) on changes in each a priori outcome, accounting for group, timepoints, and sex.||1.07|0.28|0.001
72613965|NCT03806296|144757425|SUPERIORITY||Mean Difference (Final Values)|1.1|||<|0.001|TWO_SIDED|95.0|0.61|1.59|||Regression, Linear|||For these Aim 1 analyses comparing the Early/Middle vs Late Sleep groups, the Late Sleep-Control and Late Sleep-Manipulation were combined into a single Late Sleep group. We used a linear regression model to test the effect of group (Early/Mid vs Late) on each a priori outcome, accounting for age and sex.||1.59|0.61|<0.001
72613966|NCT03806296|144757425|SUPERIORITY||Time X Group interaction|-0.76|||<|0.001|TWO_SIDED|95.0|-1.09|-0.43|||Mixed Models Analysis|||For Aim 2, this mixed effect model tested the effect of group (Control vs Manipulation) on changes in each a priori outcome, accounting for group, timepoints, and sex.||-0.43|-1.09|<0.001
72613967|NCT03806296|144757426|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.365|TWO_SIDED|95.0|-0.64|0.24|||Regression, Linear|||For these Aim 1 analyses comparing the Early/Middle vs Late Sleep groups, the Late Sleep-Control and Late Sleep-Manipulation were combined into a single Late Sleep group. We used a linear regression model to test the effect of group (Early/Mid vs Late) on each a priori outcome, accounting for age and sex.||0.24|-0.64|0.365
72613968|NCT03806296|144757426|SUPERIORITY||Time X Group interaction|-0.43||||0.067|TWO_SIDED|95.0|-0.88|0.03|||Mixed Models Analysis|||For Aim 2, this mixed effect model tested the effect of group (Control vs Manipulation) on changes in each a priori outcome, accounting for group, timepoints, and sex.||0.03|-0.88|0.067
72613969|NCT03806296|144757427|SUPERIORITY||Mean Difference (Final Values)|3.32||||0.234|TWO_SIDED|95.0|-2.18|8.82|||Regression, Linear|||For these Aim 1 analyses comparing the Early/Middle vs Late Sleep groups, the Late Sleep-Control and Late Sleep-Manipulation were combined into a single Late Sleep group. We used a linear regression model to test the effect of group (Early/Mid vs Late) on each a priori outcome, accounting for age and sex.||8.82|-2.18|0.234
72419738|NCT00406133|144350643|SUPERIORITY_OR_OTHER|||||||0.53||||||P-value for the comparison of treatment groups at 26wks adjusting for baseline for 8-14 years age group.|ANCOVA|Adjusted for the corresponding baseline value, baseline glycated hemoglobin level, clinical center, and type of continuous glucose monitor.||Continuous glucose monitoring data in both groups following the 26-week visit (blinded use in the control group and unblinded use in the continuous glucose monitoring group) were used to estimate the amount of time per day the glucose level was hypoglycemic (\<=70 mg/dL and \<=50 mg/dL), hyperglycemic (\>180 mg/dL and \>250 mg/dL), and in the target range (71 to 180 mg/dL).||||0.53
72419739|NCT00406133|144350643|SUPERIORITY_OR_OTHER|||||||0.79||||||P-value for the comparison of treatment groups at 26wks adjusting for baseline for 15-24 years age group.|ANCOVA|Adjusted for the corresponding baseline value, baseline glycated hemoglobin level, clinical center, and type of continuous glucose monitor.||||||0.79
72419740|NCT00406133|144350643|SUPERIORITY_OR_OTHER||||||<|0.001||||||P-value for the comparison of treatment groups at 26wks adjusting for baseline for \>=25 years age group.|ANCOVA|||||||<0.001
72419741|NCT00406133|144350644|SUPERIORITY_OR_OTHER|||||||0.58||||||P-value for the comparison of treatment groups at 26wks adjusting for baseline for 8-14 years age group.|ANCOVA|Adjusted for the corresponding baseline value, baseline glycated hemoglobin level, clinical center, and type of continuous glucose monitor.||Continuous glucose monitoring data in both groups following the 26-week visit (blinded use in the control group and unblinded use in the continuous glucose monitoring group) were used to estimate the amount of time per day the glucose level was hypoglycemic (\<=70 mg/dL and \<=50 mg/dL), hyperglycemic (\>180 mg/dL and \>250 mg/dL), and in the target range (71 to 180 mg/dL).||||0.58
72419742|NCT00406133|144350644|SUPERIORITY_OR_OTHER|||||||0.85||||||P-value for the comparison of treatment groups at 26wks adjusting for baseline for 15-24 years age group.|ANCOVA|Adjusted for the corresponding baseline value, baseline glycated hemoglobin level, clinical center, and type of continuous glucose monitor.||||||0.85
72419743|NCT00406133|144350644|SUPERIORITY_OR_OTHER|||||||0.002||||||P-value for the comparison of treatment groups at 26wks adjusting for baseline for \>=25 years age group.|ANCOVA|Adjusted for the corresponding baseline value, baseline glycated hemoglobin level, clinical center, and type of continuous glucose monitor.||||||0.002
72419744|NCT00406133|144350645|SUPERIORITY_OR_OTHER|||||||0.18||||||P-value for the comparison of treatment groups at 26wks adjusting for baseline for 8-14 years age group.|ANCOVA|Adjusted for the corresponding baseline value, baseline glycated hemoglobin level, clinical center, and type of continuous glucose monitor.||Continuous glucose monitoring data in both groups following the 26-week visit (blinded use in the control group and unblinded use in the continuous glucose monitoring group) were used to estimate the amount of time per day the glucose level was hypoglycemic (\<=70 mg/dL and \<=50 mg/dL), hyperglycemic (\>180 mg/dL and \>250 mg/dL), and in the target range (71 to 180 mg/dL).||||0.18
72419745|NCT00406133|144350645|SUPERIORITY_OR_OTHER|||||||0.44||||||P-value for the comparison of treatment groups at 26wks adjusting for the baseline for 15-24 years age group.|ANCOVA|Adjusted for the corresponding baseline value, baseline glycated hemoglobin level, clinical center, and type of continuous glucose monitor.||||||0.44
72419746|NCT00406133|144350645|SUPERIORITY_OR_OTHER||||||<|0.001||||||P-value for the comparison of treatment groups at 26wks adjusting for baseline for \>=25 years age group.|ANCOVA|Adjusted for the corresponding baseline value, baseline glycated hemoglobin level, clinical center, and type of continuous glucose monitor.||||||<0.001
72419747|NCT00406133|144350646|SUPERIORITY_OR_OTHER|||||||0.29||||||P-value for the comparison of treatment groups at 26wks adjusting for baseline for 8-14 years age group.|ANCOVA|Adjusted for the corresponding baseline value, baseline glycated hemoglobin level, clinical center, and type of continuous glucose monitor.||Continuous glucose monitoring data in both groups following the 26-week visit (blinded use in the control group and unblinded use in the continuous glucose monitoring group) were used to estimate the amount of time per day the glucose level was hypoglycemic (\<=70 mg/dL and \<=50 mg/dL), hyperglycemic (\>180 mg/dL and \>250 mg/dL), and in the target range (71 to 180 mg/dL).||||0.29
72419748|NCT00406133|144350646|SUPERIORITY_OR_OTHER|||||||0.79||||||P-value for the comparison of treatment groups at 26wks adjusting for baseline for 15-24 years age group.|ANCOVA|Adjusted for the corresponding baseline value, baseline glycated hemoglobin level, clinical center, and type of continuous glucose monitor.||||||0.79
72419749|NCT00406133|144350646|SUPERIORITY_OR_OTHER|||||||0.41||||||P-value for the comparison of treatment groups at 26wks adjusting for baseline for \>=25 years age group.|ANCOVA|Adjusted for the corresponding baseline value, baseline glycated hemoglobin level, clinical center, and type of continuous glucose monitor.||||||0.41
72419750|NCT00406133|144350647|SUPERIORITY_OR_OTHER|||||||0.5||||||P-value for the comparison of treatment groups at 26wks adjusting for baseline for 8-14 years age group.|ANCOVA|Adjusted for the corresponding baseline value, baseline glycated hemoglobin level, clinical center, and type of continuous glucose monitor.||Continuous glucose monitoring data in both groups following the 26-week visit (blinded use in the control group and unblinded use in the continuous glucose monitoring group) were used to estimate the amount of time per day the glucose level was hypoglycemic (\<=70 mg/dL and \<=50 mg/dL), hyperglycemic (\>180 mg/dL and \>250 mg/dL), and in the target range (71 to 180 mg/dL).||||0.50
72613970|NCT03806296|144757427|SUPERIORITY||Time X Group interaction|-6.15||||0.018|TWO_SIDED|95.0|-11.25|-1.06|||Mixed Models Analysis|||For Aim 2, this mixed effect model tested the effect of group (Control vs Manipulation) on changes in each a priori outcome, accounting for group, timepoint, and sex.||-1.06|-11.25|0.018
72613971|NCT03806296|144757428|SUPERIORITY||Mean Difference (Final Values)|0.51||||0.024|TWO_SIDED|95.0|0.07|0.94|||Regression, Linear|||For these Aim 1 analyses comparing the Early/Middle vs Late Sleep groups, the Late Sleep-Control and Late Sleep-Manipulation were combined into a single Late Sleep group. We used a linear regression model to test the effect of group (Early/Mid vs Late) on each a priori outcome, accounting for age and sex.||0.94|0.07|0.024
72419751|NCT00406133|144350647|SUPERIORITY_OR_OTHER|||||||0.99||||||P-value for the comparison of treatment groups at 26wks adjusting for baseline for 15-24 years age group.|ANCOVA|Adjusted for the corresponding baseline value, baseline glycated hemoglobin level, clinical center, and type of continuous glucose monitor.||||||0.99
72419752|NCT00406133|144350647|SUPERIORITY_OR_OTHER|||||||0.1||||||P-value for the comparison of treatment groups at 26wks adjusting for baseline for \>=25 years age group.|ANCOVA|Adjusted for the corresponding baseline value, baseline glycated hemoglobin level, clinical center, and type of continuous glucose monitor.||||||0.10
72419753|NCT00406133|144350648|SUPERIORITY_OR_OTHER|||||||0.66||||||P-value for the comparison of treatment groups at 26wks adjusting for baseline for 8-14 years age group.|ANCOVA|Adjusted for the corresponding baseline value, baseline glycated hemoglobin level, clinical center, and type of continuous glucose monitor.||Glucose variability was assessed by computing the absolute rate of change.||||0.66
72419754|NCT00406133|144350648|SUPERIORITY_OR_OTHER|||||||0.48||||||P-value for the comparison of treatment groups at 26wks adjusting for baseline for 15-24 years age group.|ANCOVA|Adjusted for the corresponding baseline value, baseline glycated hemoglobin level, clinical center, and type of continuous glucose monitor.||||||0.48
72419755|NCT00406133|144350648|SUPERIORITY_OR_OTHER|||||||0.07||||||P-value for the comparison of treatment groups at 26wks adjusting for baseline for \>=25 years age group.|ANCOVA|Adjusted for the corresponding baseline value, baseline glycated hemoglobin level, clinical center, and type of continuous glucose monitor.||||||0.07
72419756|NCT00406133|144350649|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANCOVA|Adjusted for baseline A1c and clinical center.||Other preplanned secondary outcomes included change in A1c from baseline to 26 weeks in an ANCOVA model (adjusted for baseline A1c and clinical center).||||<0.001
72419757|NCT00406133|144350650|SUPERIORITY_OR_OTHER||||||<|0.001||||||Based on the ranks of the 26wk values using VDW scores, adjusted for the baseline value, clinical center, and type of continuous glucose monitor.|ANCOVA|Adjusted for baseline value, clinical center and type of continuous glucose monitor.||Percentages of values less than or greater than a given threshold were converted to minutes per day by multiplying by 1,440. A nonparametric approach was followed using an ANCOVA based on ranks of the 26 week values, adjusted for the baseline value, clinical center, and type of continuous glucose monitor.||||<0.001
72419758|NCT00406133|144350651|SUPERIORITY_OR_OTHER|||||||0.03||||||P-value representative of 13 and 26 weeks combined.|ANCOVA|||Percentages of values less than or greater than a given threshold were converted to minutes per day by multiplying by 1,440. A nonparametric approach was followed using an ANCOVA based on ranks of the 26 week values, adjusted for the baseline value, clinical center, and type of continuous glucose monitor.||||0.03
72419759|NCT00406133|144350652|SUPERIORITY_OR_OTHER|||||||0.04||||||P-value for the 8-14 year old age group|Regression, Logistic|||Within each age group, in addition to the primary ANCOVA analysis, pre-specified 26-week binary glycated hemoglobin outcomes (relative decrease by \>=10%, 26-week level \<7.0%, absolute decrease by \>=0.5%, relative increase by \>=10%, absolute increase by \>=0.5%) were evaluated in logistic regression models, adjusted for baseline glycated hemoglobin level and clinical center.||||0.04
72419760|NCT00406133|144350652|SUPERIORITY_OR_OTHER|||||||0.46||||||P-value for the 15-24 year age group|Regression, Logistic|||||||0.46
72613972|NCT03806296|144757428|SUPERIORITY||Time X Group interaction|-0.1||||0.66|TWO_SIDED|95.0|-0.55|0.35|||Mixed Models Analysis|||For Aim 2, this mixed effect model tested the effect of group (Control vs Manipulation) on changes in each a priori outcome, accounting for group, timepoint, and sex.||0.35|-0.55|0.660
72613973|NCT03806296|144757429|SUPERIORITY||Mean Difference (Final Values)|0.01||||0.592|TWO_SIDED|95.0|-0.03|0.06|||Regression, Linear|||For these Aim 1 analyses comparing the Early/Middle vs Late Sleep groups, the Late Sleep-Control and Late Sleep-Manipulation were combined into a single Late Sleep group. We used a linear regression model to test the effect of group (Early/Mid vs Late) on each a priori outcome, accounting for age and sex.||0.06|-0.03|0.592
72419761|NCT00406133|144350652|SUPERIORITY_OR_OTHER|||||||0.003||||||P-value for the \>=25 year age group|Regression, Logistic|||||||0.003
72419762|NCT00406133|144350653|SUPERIORITY_OR_OTHER|||||||0.24||||||P-value for 8-14 year old age group|Regression, Logistic|||Within each age group, in addition to the primary ANCOVA analysis, pre-specified 26-week binary glycated hemoglobin outcomes (relative decrease by \>=10%, 26-week level \<7.0%, absolute decrease by \>=0.5%, relative increase by \>=10%, absolute increase by \>=0.5%) were evaluated in logistic regression models, adjusted for baseline glycated hemoglobin level and clinical center.||||0.24
72419763|NCT00406133|144350653|SUPERIORITY_OR_OTHER|||||||0.98||||||P-value for the 15-24 year old age group|Regression, Logistic|||||||0.98
72419764|NCT00406133|144350653|SUPERIORITY_OR_OTHER|||||||0.48||||||P-value for the \>=25 year old age group|Regression, Logistic|||||||0.48
72419765|NCT00406133|144350654|SUPERIORITY_OR_OTHER|||||||0.005||||||P-value representative of 13 and 26 weeks combined|ANCOVA|||Percentages of values less than or greater than a given threshold were converted to minutes per day by multiplying by 1,440. A nonparametric approach was followed using an ANCOVA based on ranks of the 26 week values, adjusted for the baseline value, clinical center, and type of continuous glucose monitor.||||0.005
72419766|NCT00406133|144350655|SUPERIORITY_OR_OTHER|||||||0.05||||||P-value representative of 13 and 26 weeks combined.|ANCOVA|||Percentages of values less than or greater than a given threshold were converted to minutes per day by multiplying by 1,440. A nonparametric approach was followed using an ANCOVA based on ranks of the 26 week values, adjusted for the baseline value, clinical center, and type of continuous glucose monitor.||||0.05
72419767|NCT00406133|144350656|SUPERIORITY_OR_OTHER|||||||0.39||||||P-value representative of 13 and 26 weeks combined.|ANCOVA|||Glucose variability was assessed by computing the absolute rate of change.||||0.39
72419768|NCT00406133|144350657|SUPERIORITY_OR_OTHER|||||||0.04|TWO_SIDED|||||Nominal p-value not adjusted for multiple comparisons|ANCOVA|||||||0.04
72613974|NCT03806296|144757429|SUPERIORITY||Time X Group interaction|-0.03||||0.55|TWO_SIDED|95.0|-0.11|0.06|||Mixed Models Analysis|||For Aim 2, this mixed effect model tested the effect of group (Control vs Manipulation) on changes in each a priori outcome, accounting for group, timepoint, and sex.||0.06|-0.11|0.550
72613975|NCT03806296|144757430|SUPERIORITY||Mean Difference (Final Values)|-0.02||||0.55|TWO_SIDED|95.0|-0.07|0.04|||Regression, Linear|||For these Aim 1 analyses comparing the Early/Middle vs Late Sleep groups, the Late Sleep-Control and Late Sleep-Manipulation were combined into a single Late Sleep group. We used a linear regression model to test the effect of group (Early/Mid vs Late) on each a priori outcome, accounting for age and sex.||0.04|-0.07|0.550
72419769|NCT00406133|144350658|SUPERIORITY_OR_OTHER||Ratio of treatment differences|408148.0|||||TWO_SIDED|95.0|-176644.0|3475108.0||||||"ICER = Incremental Cost Effectiveness Ratio is defined as the mean difference in costs between the treatment groups divided by the mean difference in QALY (quality-adjusted life-year) between the treatment groups:~(mean cost\[CGM\] - mean cost \[control\]) / (mean QALY\[CGM\] - mean QALY\[SMBG\]).~Units are dollars per QALY."||3475108|-176644|
72419770|NCT00406133|144350659|SUPERIORITY_OR_OTHER|||||||0.009||||||P-value for the 8-14 year old age group|Regression, Logistic|||Within each age group, in addition to the primary ANCOVA analysis, pre-specified 26-week binary glycated hemoglobin outcomes (relative decrease by \>=10%, 26-week level \<7.0%, absolute decrease by \>=0.5%, relative increase by \>=10%, absolute increase by \>=0.5%) were evaluated in logistic regression models, adjusted for baseline glycated hemoglobin level and clinical center.||||0.009
72419771|NCT00406133|144350659|SUPERIORITY_OR_OTHER|||||||0.57||||||P-value for 15-24 year old age group|Regression, Logistic|||||||0.57
72613976|NCT03806296|144757430|SUPERIORITY||Time X Group interaction|-0.02||||0.556|TWO_SIDED|95.0|-0.1|0.06|||Mixed Models Analysis|||For Aim 2, this mixed effect model tested the effect of group (Control vs Manipulation) on changes in each a priori outcome, accounting for group, timepoint, and sex.||0.06|-0.10|0.556
72613977|NCT03806296|144757431|SUPERIORITY||Mean Difference (Final Values)|0.03||||0.124|TWO_SIDED|95.0|-0.01|0.06|||Regression, Linear|||For these Aim 1 analyses comparing the Early/Middle vs Late Sleep groups, the Late Sleep-Control and Late Sleep-Manipulation were combined into a single Late Sleep group. We used a linear regression model to test the effect of group (Early/Mid vs Late) on each a priori outcome, accounting for age and sex.||0.06|-0.01|0.124
72613978|NCT03806296|144757431|SUPERIORITY||Time X Group interaction|0.0||||0.925|TWO_SIDED|95.0|-0.05|0.06|||Mixed Models Analysis|||For Aim 2, this mixed effect model tested the effect of group (Control vs Manipulation) on changes in each a priori outcome, accounting for group, timepoint, and sex.||0.06|-0.05|0.925
72613979|NCT03806296|144757432|SUPERIORITY||Risk Ratio (RR)|0.752||||0.42|TWO_SIDED|95.0|0.374|1.513|||Poisson GLM with robust standard error||Early/Middle Sleep group was the reference group (lower RR indicates less likelihood of cannabis use in the Late Sleep group)|For these Aim 1 analyses comparing the Early/Middle vs Late Sleep groups, the Late Sleep-Control and Late Sleep-Manipulation were combined into a single Late Sleep group. We used a Poisson generalized linear model (GLM) to test the effect of group (Early/Mid vs Late) on a binary cannabis use outcome (yes/no in the past 3 months), accounting for age and sex.||1.513|0.374|0.42
72613980|NCT03806296|144757433|SUPERIORITY||Risk Ratio (RR)|1.236||||0.461|TWO_SIDED|95.0|0.704|2.171|||Poisson GLM with robust standard error||Early/Middle Sleep group was the reference group (higher RR indicates higher likelihood of alcohol use in the Late Sleep group)|For these Aim 1 analyses comparing the Early/Middle vs Late Sleep groups, the Late Sleep-Control and Late Sleep-Manipulation were combined into a single Late Sleep group. We used a Poisson generalized linear model (GLM) to test the effect of group (Early/Mid vs Late) on a binary alcohol use outcome (yes/no in the past 3 months), accounting for age and sex.||2.171|0.704|0.461
72613981|NCT03806296|144757433|SUPERIORITY||Incident Rate Ratio|3.29||||0.007|TWO_SIDED|95.0|1.36|7.9|||negative binomial glm||Early/Middle Sleep group was the reference group (higher IRR indicates greater days of alcohol use in the Late Sleep group than in the Early/Middle Sleep group).|For these Aim 1 analyses comparing the Early/Middle vs Late Sleep groups, the Late Sleep-Control and Late Sleep-Manipulation were combined into a single Late Sleep group. We used a negative binomial GLM to test the effect of group (Early/Mid vs Late) on days of alcohol use, accounting for age and sex.||7.90|1.36|0.007
72613982|NCT04896385|144757438|OTHER|||||||0.004|||||||repeated measures correlation|||F-VASI||||0.004
72613983|NCT04896385|144757438|OTHER|||||||0.41|||||||repeated measures correlation|||F-VASI||||0.41
72613984|NCT04896385|144757438|OTHER|||||||0.0002|||||||repeated measures correlation|||T-VASI||||0.0002
72613985|NCT04896385|144757438|OTHER|||||||0.91|||||||repeated measures correlation|||T-VASI||||0.91
72613986|NCT04235374|144757467|SUPERIORITY||Mean Difference (Final Values)|0.06|||<|0.05|TWO_SIDED|95.0|||||Mixed Models Analysis|||||||<.05
72613987|NCT04235374|144757468|SUPERIORITY||Mean Difference (Final Values)|0.05|||<|0.05|TWO_SIDED|95.0|||||Mixed Models Analysis|||||||<.05
72613988|NCT04235374|144757469|SUPERIORITY||Mean Difference (Final Values)|0.05||||0.05|TWO_SIDED|95.0|||||Mixed Models Analysis|||||||.05
72613989|NCT04235374|144757470|SUPERIORITY||Mean Difference (Final Values)|0.05||||0.05|TWO_SIDED|95.0|||||Mixed Models Analysis|||||||.05
72613990|NCT04235374|144757471|SUPERIORITY||Mean Difference (Final Values)|0.05||||0.05|TWO_SIDED|95.0|||||Mixed Models Analysis|||||||.05
72613991|NCT00088153|144757472|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05||95.0||||After controlling for baseline age and weight changes|t-test, 2 sided|We also used a mixed model analysis of variance (PROC MIXED), to analyze longitudinal data.||Power analysis: We have previously demonstrated that normal female adolescents gain bone density at the rate of 0.039 +/- 0.0507 per year. The pooled SD in that study was 0.046. Based on these data, with a sample size of 110 girls with anorexia nervosa (AN), half of whom are randomized to receive estrogen and half placebo (with a 10% drop-out rate), there will be an 80% chance that we will detect an increase in bone density to 75% of normal in the girls who receive estrogen.||||<0.05
72613992|NCT00088153|144757473|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05||95.0|||||t-test, 2 sided|||The null hypothesis was that there would be no differences between the groups for changes in P1NP levels over time||||>0.05
72613993|NCT00088153|144757474|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05||95.0||||The p value was adjusted for age and weight changes|t-test, 2 sided|||The null hypothesis was that the groups would not differ for changes in spine bone density z-scores over the study duration||||<0.05
72613994|NCT04435626|144757486|SUPERIORITY||Rate ratio|0.84||||0.0072|TWO_SIDED|95.0|0.74|0.95||Two-sided p-value; p-value threshold =0.04967;|stratified Andersen-Gill model|stratified Andersen-Gill model with robust sandwich estimate for the covariance matrix of recurrent events|stratified Andersen-Gill model with robust sandwich estimate for the covariance matrix of recurrent events|Rate Ratio (Finerenone/Placebo)||0.95|0.74|0.0072
72613995|NCT04435626|144757488|SUPERIORITY||Rate ratio|0.82||||0.0062|TWO_SIDED|95.0|0.71|0.94||Two-sided p-value; p-value threshold=0.04967;|Stratified Andersen-Gill model|stratified Andersen-Gill model with robust sandwich estimate for the covariance matrix of recurrent events|stratified Andersen-Gill model with robust sandwich estimate for the covariance matrix of recurrent events|Rate Ratio (Finerenone/Placebo)||0.94|0.71|0.0062
72613996|NCT04435626|144757490|OTHER|mixed-effects model for repeated measures (MMRM)|Difference in LS Mean|1.56|||<|0.0001|TWO_SIDED|95.0|0.79|2.34||Two-sided p-value;|Mixed Models Analysis|The analysis was performed using mixed-effects model for repeated measures (MMRM)||Difference in LS Mean||2.34|0.79|<.0001
72613997|NCT04435626|144757491|OTHER|Logistic regression analysis|Odds Ratio (OR)|1.01||||0.9295|TWO_SIDED|95.0|0.88|1.15||Two-sided p-value|Regression, Logistic|||Odds ratio (finerenone /placebo)||1.15|0.88|0.9295
72327405|NCT00149799|144178415|SUPERIORITY||Slope difference|0.05723|STANDARD_ERROR_OF_MEAN|0.1963||0.7724|TWO_SIDED|||||A priori threshold for statistical significance: 0.0167 Model term of interest: treatment by time interaction (i.e., slope difference between treatments over time)|Mixed Models Analysis|Degrees of freedom=36||"We compared change in Q-LES-Q-SF percent scores over time by randomized treatment group (Escitalopram vs. Placebo) using a random coefficient model that included terms for treatment group, time, site, and all their interactions, modeling intercepts and slopes as random effects per person.~Null hypothesis: The rate of change in Q-LES-Q-SF percent scores in the Escitalopram group will not be significantly different from that of the placebo group \[to be tested\]."||||0.7724
72419772|NCT00406133|144350659|SUPERIORITY_OR_OTHER||||||<|0.001||||||P-value for the \>=25 year old age group|Regression, Logistic|||||||<0.001
72419773|NCT00406133|144350660|SUPERIORITY_OR_OTHER|||||||0.18||||||P-value for 8-14 year age group|Regression, Logistic|||Within each age group, in addition to the primary ANCOVA analysis, pre-specified 26-week binary glycated hemoglobin outcomes (relative decrease by \>=10%, 26-week level \<7.0%, absolute decrease by \>=0.5%, relative increase by \>=10%, absolute increase by \>=0.5%) were evaluated in logistic regression models, adjusted for baseline glycated hemoglobin level and clinical center.||||0.18
72613998|NCT04435626|144757492|OTHER|Stratified log-rank test|Cause-specific Hazard Ratio|1.33||||0.1071|TWO_SIDED|95.0|0.94|1.89||two-sided p-value|Stratified log-rank test||stratified Cox proportional hazards model|Cause-specific Hazard Ratio||1.89|0.94|0.1071
72613999|NCT04435626|144757493|OTHER|Stratified log-rank test|cause-specific hazard ratio|0.93||||0.2794|TWO_SIDED|95.0|0.83|1.06||two-sided p-value|stratified log-rank||stratified Cox proportional hazards model|Hazard Ratio||1.06|0.83|0.2794
72614000|NCT04426656|144757494|SUPERIORITY|||||||0.85|||||||Wilcoxon (Mann-Whitney)|||The comparison was made using the outcome variable measured at Week 12.||||0.85
72614001|NCT04426656|144757495|SUPERIORITY|||||||0.72|||||||Chi-squared|||||||0.72
72614002|NCT04426656|144757496|SUPERIORITY|||||||0.318|||||||Fisher Exact|||||||0.318
72614003|NCT04426656|144757497|SUPERIORITY|||||||0.527|||||||Fisher Exact|||||||0.527
72614004|NCT04426656|144757498|SUPERIORITY|||||||0.928|||||||Fisher Exact|||||||0.928
72614005|NCT04426656|144757499|SUPERIORITY|||||||0.678|||||||Fisher Exact|||||||0.678
72614006|NCT04426656|144757500|SUPERIORITY|||||||0.26|||||||Wilcoxon (Mann-Whitney)|||The comparison test was made using the outcome variable measured at Week 12.||||0.26
72614007|NCT04426656|144757501|SUPERIORITY|||||||0.08|||||||Fisher Exact|||The comparison was made using data measured at Week 12.||||0.08
72614008|NCT04426656|144757502|SUPERIORITY|||||||0.03|||||||Wilcoxon (Mann-Whitney)|||The comparison was made using data measured at Week 12.||||0.03
72614009|NCT04426656|144757503|SUPERIORITY|||||||0.58|||||||Wilcoxon (Mann-Whitney)|||This comparison was made using data at Week 12.||||0.58
72614010|NCT04426656|144757504|SUPERIORITY|||||||0.85|||||||Wilcoxon (Mann-Whitney)|||The comparison was made using data measured at Week 12.||||0.85
72614011|NCT04357795|144757541|OTHER|Single group analysis|||||<|0.0001|||||||Paired t-test|||||||<0.0001
72614012|NCT04357795|144757542|OTHER|Single group analysis|||||<|0.0001|||||||Paired t-test|||||||<0.0001
72614013|NCT04357795|144757543|OTHER|Single group analysis|||||<|0.0001|||||||Paired t-test|||||||<0.0001
72614014|NCT04357795|144757544|OTHER|Single group analysis|||||<|0.0001|||||||Paired t-test|||||||<0.0001
72614015|NCT04357795|144757545|OTHER|Single group analysis||||||0.0323|||||||Paired t-test|OD- Right eye p value||||||0.0323
72614016|NCT04357795|144757545|OTHER|Single group analysis||||||0.3447||||||OS: P-Value|Paired t-test|||||||0.3447
72614017|NCT04357795|144757546|OTHER|Single group analysis|||||<|0.0001|||||||Paired t-test|||||||<0.0001
72614018|NCT04357795|144757547|OTHER|Single group analysis||||||0.0029|||||||Paired t-test|||||||0.0029
72614019|NCT02595892|144757555|OTHER||Hazard Ratio (HR)|0.57||||0.044|TWO_SIDED|90.0|0.33|0.98|||Log Rank|||||.98|.33|0.044
72614020|NCT02595892|144757558|OTHER|||||||0.44|||||||Fisher Exact|Two-Sided Fisher's exact test.||||||0.44
72614021|NCT05252702|144757601|SUPERIORITY|"The primary safety endpoint hypothesis at 3 months was formally expressed as:~H0: CFR ≤ 78% vs. H1: CFR \> 78%~where 78% was the performance goal (PG)."|binomial proportion|90.3|||<|0.0001|ONE_SIDED|97.5|87.0|||The CFR was estimated as a binomial proportion and a one-sided 97.5% lower confidence bound of the CFR was calculated using the normal approximation. The null hypothesis was to be rejected at the 2.5% significance level if the LCB exceeded the PG|one-sided Z-test|The p-value from a one-sided Z-test for the binomial proportion was calculated and compared to the 0.025 significance level.|||||87|<0.0001
72614022|NCT05252702|144757602|SUPERIORITY|"The primary safety endpoint hypothesis at 12 months was formally expressed as:~H0: CFR ≤ 76.5% vs. H1: CFR \> 76.5%~where 76.5% is the performance goal. The CFR was estimated using a Kaplan-Meier survival analysis and the 97.5% lower confidence bound of CFR was calculated using the Greenwood variance estimates."|Kaplan-Meier|88.6|||<|0.0001|ONE_SIDED|97.5|84.5|||The null hypothesis was to be rejected at the 2.5% significance level if the LCB exceeded the Performance Goal (PG) of 76.5%.|one-sided Z-test|The p-value for the one-sided Z-test was calculated and compared to the 2.5% significance level.|||||84.5|<0.0001
72614023|NCT05252702|144757603|SUPERIORITY||binomial proportion|90.8|||<|0.0001|ONE_SIDED|97.5|87.5|||The null hypothesis was to be rejected at the 2.5% significance level if the LCB exceeded the PG of 82.5%.|one-sided Z-test|The p-value for the one-sided Z-test was to be calculated and compared to the 2.5% significance level.||"The primary effectiveness endpoint #1 hypothesis at 3 month was formally expressed as:~H0: Rate ≤ 82.5% vs. H1: Rate \> 82.5%~where 82.5% was the performance goal (PG)."|||87.5|<0.0001
72614024|NCT05252702|144757604|SUPERIORITY||binomial proportion|92.8|||<|0.0001|ONE_SIDED|97.5|89.7|||The null hypothesis was to be rejected at the 2.5% significance level if the LCB exceeded the PG of 80%.|one-sided Z-test|The p-value for the one-sided Z-test was to be calculated and compared to the 2.5% significance level.|The Rate at 12 months was estimated as a binomial proportion and the one-sided 97.5% LCB of the Rate was calculated using the normal approximation.|"The primary effectiveness endpoint #1 hypothesis at 12 months was formally expressed as:~H0: Rate ≤ 80% vs. H1: Rate \> 80%~where 80% was the performance goal (PG)."|||89.7|<0.0001
72614025|NCT05252702|144757605|SUPERIORITY||binomial proportion|98.2|||<|0.0001|ONE_SIDED|97.5|96.6|||The null hypothesis was to be rejected at the 2.5% significance level if the LCB exceeded the PG of 83%.|one-sided Z-test|The p-value for the one-sided Z-test was to be calculated and compared to the 2.5% significance level.||"The primary effectiveness endpoint #2 hypothesis was formally expressed as:~H0: RateAV ≤ 83% vs. H1: RateAV \> 83%~where 83% is the performance goal."|||96.6|<0.0001
72614026|NCT05252702|144757606|SUPERIORITY||binomial proportion|91.3||||0.0003|ONE_SIDED|97.5|88.1|||The null hypothesis was to be rejected at the 2.5% significance level if the lower confidence bound exceeded the Performance Goal (PG) of 84%.|one-sided Z-test|The p-value from a one-sided Z-test for the binomial proportion was to be calculated and compared to the 0.025 significance level.||"The secondary safety endpoint hypothesis at 3 months was formally expressed as:~H0: CFRA ≤ 84% vs. H1: CFRA \> 84%~where 84% was the performance goal."|||88.1|0.0003
72614027|NCT05252702|144757607|SUPERIORITY||Kaplan-Meier|91.0|STANDARD_ERROR_OF_MEAN|1.7|<|0.0001|ONE_SIDED|97.5|87.1|||The null hypothesis was to be rejected at the 2.5% significance level if the LCB exceeded the Performance Goal (PG) of 82%.|one-sided Z-test|The p-value for the one-sided Z-test was to be calculated and compared to the 2.5% significance level.|The 97.5% lower confidence bound (LCB) of CFRA was calculated using the Greenwood variance estimates.|"The secondary safety endpoint hypothesis at 12 months was formally expressed as:~H0: CFRA ≤ 82% vs. H1: CFRA \> 82%~where 82% is the performance goal."|||87.1|<0.0001
72614028|NCT05252702|144757608|OTHER||mixed effects model for repeated measure|0.91|STANDARD_ERROR_OF_MEAN|0.06|<|0.001|TWO_SIDED|95.0|0.78|1.04|||t-test, 1 sided|Two one-sided t-tests (TOST), with an alpha level of 0.025, and n-1 degrees of freedom.||"An analysis of these data provided an estimate of the 95% confidence interval for the mean slope across analyzable subjects, which had a pre-specified success criterion requiring that this confidence interval must fall between slopes of 65% and 135%. The following hypothesis was evaluated:~H0: Mean Slope \< 0.65 or Mean Slope \> 1.35~H1: 0.65 ≤ Mean Slope ≤ 1.35"||1.04|0.78|<0.001
72614029|NCT00569127|144757610|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.93||||0.55|TWO_SIDED|95.0|0.73|1.18||Central-review based progression-free survival was analyzed using the stratified log rank test (which is the score test from the stratified Cox-model) using stratification factors as defined in Section 6.0.|Regression, Cox||The reported hazard ratio estimate is for the comparison of the Octreotide, Bevacizumab arm to the Octreotide, Interferon Alpha-2b arm.|According to the intent-to-treat principle, all eligible patients were included in the analysis according to the randomized treatment assignment, regardless of actual treatments received.||1.18|0.73|0.55
72614030|NCT06442800|144757615|SUPERIORITY||Mean Difference (Final Values)|1.31|||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||Multiple cancers vs. Control||||<0.001
72614031|NCT06442800|144757615|SUPERIORITY||Mean Difference (Final Values)|1.19|||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||Dementia vs. Control||||<0.001
72614032|NCT06442800|144757615|SUPERIORITY||Mean Difference (Final Values)|1.17|||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||Colorectal cancer vs. Control||||<0.001
72614033|NCT06442800|144757615|SUPERIORITY||Mean Difference (Final Values)|1.15|||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||Liver cancer vs. Control||||<0.001
72614034|NCT06442800|144757615|SUPERIORITY||Mean Difference (Final Values)|1.14|||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||Throat and mouth cancer vs. Control||||<0.001
72614035|NCT06442800|144757615|SUPERIORITY||Mean Difference (Final Values)|1.11|||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||Liver disease vs. Control||||<0.001
72614036|NCT06442800|144757615|SUPERIORITY||Mean Difference (Final Values)|0.98|||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||Hypertension vs. Control||||<0.001
72614037|NCT06442800|144757615|SUPERIORITY||Mean Difference (Final Values)|0.81|||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||Current warning vs. Control||||<0.001
72614038|NCT06442800|144757615|SUPERIORITY||Mean Difference (Final Values)|0.58|||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||Guidelines vs. Control||||<0.001
72614039|NCT06442800|144757616|SUPERIORITY||Mean Difference (Final Values)|1.75|||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||Multiple cancers vs. Control||||<0.001
72614040|NCT06442800|144757616|SUPERIORITY||Mean Difference (Final Values)|1.59|||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||Dementia vs. Control||||<0.001
72614041|NCT06442800|144757616|SUPERIORITY||Mean Difference (Final Values)|1.54|||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||Colorectal cancer vs. Control||||<0.001
72614042|NCT06442800|144757616|SUPERIORITY||Mean Difference (Final Values)|1.6|||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||Liver cancer vs. Control||||<0.001
72614043|NCT06442800|144757616|SUPERIORITY||Mean Difference (Final Values)|1.66|||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||Throat and mouth cancer vs. Control||||<0.001
72614044|NCT06442800|144757616|SUPERIORITY||Mean Difference (Final Values)|1.52|||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||Liver disease vs. Control||||<0.001
72614045|NCT06442800|144757616|SUPERIORITY||Mean Difference (Final Values)|1.45|||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||Hypertension vs. Control||||<0.001
72614046|NCT06442800|144757616|SUPERIORITY||Mean Difference (Final Values)|1.52|||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||Current warning vs. Control||||<0.001
72614047|NCT06442800|144757616|SUPERIORITY||Mean Difference (Final Values)|0.93|||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||Guidelines vs. Control||||<0.001
72614048|NCT06442800|144757617|SUPERIORITY||Difference in predicted proportions|0.38|||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||Multiple cancers vs. Control||||<0.001
72614049|NCT06442800|144757617|SUPERIORITY||Difference in predicted proportions|0.34|||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||Dementia vs. Control||||<0.001
72614050|NCT06442800|144757617|SUPERIORITY||Difference in predicted proportions|0.4|||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||Colorectal cancer vs. Control||||<0.001
72614051|NCT06442800|144757617|SUPERIORITY||Difference in predicted proportions|0.14|||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||Liver cancer vs. Control||||<0.001
72327406|NCT01072136|144178417|NON_INFERIORITY_OR_EQUIVALENCE|Under the assumption of a clinical cure proportion of 75% for the Azithromycin/Cefixime group, a 10% non-inferiority margin (i.e., no more than a 10% lower cure rate in the placebo group) at the one-sided 0.05 significance level with 85% power required 270 study participants in each arm (540 total) using an unpooled Z-test (normal approximation). Anticipating that approximately 30% of enrolled participants would not be in the per protocol group, 772 participants were targeted for enrollment.|Risk Difference (RD)|14.0|||||ONE_SIDED|95.0|-12.2||||||Asymptotic one-sided 95% confidence limit for the difference in clinical cure proportions(placebo minus treatment) were computed so that the lower limit could be examined relative to the non-inferiority margin of -10%.|The primary efficacy outcome was MPC clinical cure at 2 months. This was a non-inferiority trial designed to reject the null hypothesis that placebo control is inferior to empiric therapy for MPC.|||-12.2|
72327407|NCT01342926|144178480|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.07|||||TWO_SIDED|90.0|-0.57|0.43|||||6 months visit|||0.43|-0.57|
72327408|NCT01342926|144178480|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.2|||||TWO_SIDED|90.0|-0.31|0.71|||||12 months visit|||0.71|-0.31|
72327409|NCT01342926|144178480|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.17|||||TWO_SIDED|90.0|-0.33|0.68|||||18 months visit|||0.68|-0.33|
72327410|NCT01342926|144178480|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.23|||||TWO_SIDED|90.0|-0.71|0.26|||||6 months visit|||0.26|-0.71|
72614052|NCT06442800|144757617|SUPERIORITY||Difference in predicted proportions|0.37|||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||Throat and mouth cancer vs. Control||||<0.001
72614053|NCT06442800|144757617|SUPERIORITY||Difference in predicted proportions|0.11|||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||Liver disease vs. Control||||<0.001
72614054|NCT06442800|144757617|SUPERIORITY||Difference in predicted proportions|0.25|||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||Hypertension vs. Control||||<0.001
72614055|NCT06442800|144757617|SUPERIORITY||Difference in predicted proportions|0.04||||0.02|TWO_SIDED||||||Mixed Models Analysis|||Current warning vs. Control||||0.02
72614056|NCT06442800|144757617|SUPERIORITY||Difference in predicted proportions|0.14|||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||Guidelines vs. Control||||<0.001
72614057|NCT05119569|144757700|SUPERIORITY||Rate Ratio|0.313||||0.0022|TWO_SIDED|95.0|0.149|0.658|||Negative Binomial Regression Model|||||0.658|0.149|0.0022
72614058|NCT05119569|144757701|SUPERIORITY||Rate Ratio|0.265||||0.0004|TWO_SIDED|95.0|0.128|0.55|||Negative Binomial Regression Model|||||0.550|0.128|0.0004
72614059|NCT05119569|144757702|SUPERIORITY||Odds Ratio (OR)|4.005||||0.0117|TWO_SIDED|95.0|1.317|13.078|||Logistic Regression Model|||||13.078|1.317|0.0117
72614060|NCT05119569|144757707|SUPERIORITY||Rate Ratio|0.78||||0.5889|TWO_SIDED|95.0|0.316|1.922|||Negative Binomial Regression Model|||||1.922|0.316|0.5889
72614061|NCT05119569|144757708|SUPERIORITY||Rate Ratio|0.076||||0.0011|TWO_SIDED|95.0|0.016|0.355|||Negative Binomial Regression Model|||||0.355|0.016|0.0011
72614062|NCT05119569|144757709|SUPERIORITY||Rate Ratio|0.104||||0.0038|TWO_SIDED|95.0|0.022|0.481|||Negative Binomial Regression Model|||||0.481|0.022|0.0038
72614063|NCT05119569|144757710|SUPERIORITY||Rate Ratio|0.512||||0.0958|TWO_SIDED|95.0|0.233|1.126|||Negative Binomial Regression Model|||||1.126|0.233|0.0958
72614064|NCT05119569|144757711|SUPERIORITY||Rate Ratio|0.105|||<|0.0001|TWO_SIDED|95.0|0.039|0.283|||Negative Binomial Regression Model|||||0.283|0.039|<0.0001
72614065|NCT05119569|144757712|SUPERIORITY||Rate Ratio|0.053||||0.0001|TWO_SIDED|95.0|0.012|0.233|||Negative Binomial Regression Model|||||0.233|0.012|0.0001
72614066|NCT00434434|144757713|SUPERIORITY_OR_OTHER_LEGACY|||||||0.13||95.0|||||Wilcoxon (Mann-Whitney)|exact Wilcoxon-Mann-Whitney||||||0.13
72614067|NCT00434434|144757713|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0133||95.0|||||Wilcoxon (Mann-Whitney)|exact Wilcoxon-Mann-Whitney||||||0.0133
72614068|NCT00434434|144757714|SUPERIORITY_OR_OTHER_LEGACY|||||||0.09||95.0|||||Wilcoxon (Mann-Whitney)|exact Wilcoxon-Mann-Whitney||||||0.09
72614069|NCT00434434|144757714|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0028||95.0|||||Wilcoxon (Mann-Whitney)|exact Wilcoxon-Mann-Whitney||||||0.0028
72614070|NCT02290184|144757716|SUPERIORITY_OR_OTHER|A multi-level regression was employed to test differences between the 2 arm's change trajectories of their estimated simple slopes. Bootstrapped full information maximum likelihood models were estimated to obtain nonparametric, bias-corrected confidence interval (CI).|cross-level interaction|-2.0|||||TWO_SIDED|0.05|-3.0|-1.1|||||"Multilevel regression analysis was used. The primary test of between-group change effect is also called the cross-level interaction between time and group. Simple slopes were also tested to determine if the change was significant within each group."|Hypothesis: the intervention group will have a significantly greater reduction in weight (kg) compared to the active control from baseline to 3-months.||-1.1|-3.0|
72614071|NCT02290184|144757717|SUPERIORITY|Multi-level regression was used to test differences between the 2 arm's change trajectories of their estimated simple slopes. Bootstrapped full information maximum likelihood models were estimated to obtain nonparametric, bias-corrected CI.|cross-level interaction|-2.6|||||TWO_SIDED|0.05|-3.9|-1.4|||||"Multilevel regression was used. The primary test of between group change effect is also called the cross-level interaction between time and group. Simple slopes were also tested to determine if the change was significant within each group."|Hypothesis: Intervention group will have a significantly greater reduction in % weight change compared to the active control from baseline to 3-months||-1.4|-3.9|
72614072|NCT02290184|144757718|SUPERIORITY|A multi-level regression was used to test differences between the 2 arm's change trajectories of their estimated simple slopes. Bootstrapped full information maximum likelihood models were estimated to obtain nonparametric, bias-corrected CI.|cross-level interaction|-2.7|||||TWO_SIDED|95.0|-4.5|-0.91|||||"Multilevel regression was used. The primary test of between -group change effect is also called the cross-level interaction between time and group. Simple slopes were also tested to determine if the change was significant within each group."|Hypothesis: Intervention group will have a significantly greater reduction in waist-circumference (cm) compared to the Active Control from baseline to 3-months||-.91|-4.5|
72614073|NCT01069939|144757719|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.09|||<|0.001|TWO_SIDED|96.65|0.02|0.41||An interim analysis was done so that the significance level was adjusted using the Pocock-like alpha-spending function with Lan-DeMets approach. The adjusted significance level was the two-sided 3.35%.|Log Rank|||The above two groups were compared.||0.41|0.02|<0.001
72614074|NCT01017250|144757746|SUPERIORITY_OR_OTHER|||||||0.04||95.0|||||Wilcoxon signed rank|||This was a test on the change from baseline to the post-SRS time point for all patients.||||0.04
72327411|NCT01342926|144178480|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.23|||||TWO_SIDED|90.0|-0.26|0.72|||||12 months visit|||0.72|-0.26|
72614075|NCT01017250|144757747|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||Wilcoxon signed rank|||This was a test on the change from baseline to the post-SRS time point for all patients.||||0.002
72614076|NCT01017250|144757748|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||Wilcoxon signed rank|||This was a test on the change from baseline to the post-SRS time point for all patients.||||0.02
72614077|NCT01017250|144757749|SUPERIORITY_OR_OTHER|||||||0.0005||95.0|||||Wilcoxon signed rank|||This was a test on the change from baseline to the post-SRS time point for all patients.||||0.0005
72614078|NCT01017250|144757750|SUPERIORITY_OR_OTHER|||||||0.53||95.0|||||Wilcoxon signed rank|||This was a test on the change from baseline to the post-SRS time point for all patients.||||0.53
72614079|NCT01017250|144757751|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||Wilcoxon signed rank|||This was a test on the change from baseline to the post-SRS time point for all patients.||||0.002
72614080|NCT01017250|144757752|SUPERIORITY_OR_OTHER|||||||0.76||95.0|||||Wilcoxon signed rank|||This was a test on the change from baseline to the post-SRS time point for all patients.||||0.76
72614081|NCT01017250|144757753|SUPERIORITY_OR_OTHER|||||||0.34||95.0|||||Wilcoxon signed rank|||This was a test on the change from baseline to the post-SRS time point for all patients.||||0.34
72614082|NCT04835441|144757773|SUPERIORITY|||||||0.107|||||||Cochran-Mantel-Haenszel|||||||0.107
72614083|NCT04835441|144757774|SUPERIORITY|||||||0.308|||||||Cochran-Mantel-Haenszel|||||||0.308
72614084|NCT04835441|144757775|SUPERIORITY|||||||0.442|||||||ANOVA|||||||0.442
72614085|NCT04835441|144757776|SUPERIORITY|||||||0.788|||||||Kaplan-Meier methods|||||||0.788
72327412|NCT01342926|144178480|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.28|||||TWO_SIDED|90.0|-0.21|0.77|||||18 months visit|||0.77|-0.21|
72614086|NCT04835441|144757777|SUPERIORITY|||||||0.792|||||||Cochran-Mantel-Haenszel|||||||0.792
72614087|NCT04835441|144757778|SUPERIORITY|||||||0.302|||||||Mixed models for repeated measures|||||||0.302
72614088|NCT04835441|144757779|SUPERIORITY|||||||0.506|||||||ANOVA|||||||0.506
72614089|NCT04835441|144757780|SUPERIORITY|||||||0.659|||||||Fisher Exact|||||||0.659
72614090|NCT04070703|144757789|SUPERIORITY|The co-primary outcome data were analyzed via a Group by Time mixed-effects model with repeated measures on the second factor (i.e., outcome measures assessed at baseline and 6 months. In the presence of a Group by Time interaction effect, pre-specified follow-up pair-wise comparisons were performed to determine between-group differences.|Mean Difference (Final Values)|2.8||||0.0125|TWO_SIDED|98.75|2.1|3.6|||Mixed Models Analysis|||||3.6|2.1|0.0125
72614091|NCT04070703|144757789|SUPERIORITY||Mean Difference (Final Values)|1.5||||0.0125|TWO_SIDED|98.75|0.07|2.2|||Mixed Models Analysis|||||2.2|.07|.0125
72614092|NCT04070703|144757790|SUPERIORITY||Mean Difference (Final Values)|9.9||||0.0125|TWO_SIDED|98.75|2.8|16.6|||Mixed Models Analysis|||||16.6|2.8|.0125
72614093|NCT04070703|144757790|SUPERIORITY||Mean Difference (Final Values)|22.0||||0.0125|TWO_SIDED|98.75|12.6|31.2|||Mixed Models Analysis|||||31.2|12.6|.0125
72614094|NCT04070703|144757791|SUPERIORITY||Mean Difference (Final Values)|-0.3||||0.05|TWO_SIDED|95.0|-0.5|-0.1|||Mixed Models Analysis|||||-.1|-.5|0.05
72614095|NCT04070703|144757791|SUPERIORITY||Mean Difference (Final Values)|-0.6||||0.05|TWO_SIDED|95.0|-0.7|-0.3|||Mixed Models Analysis|||||-.3|-.7|.05
72614096|NCT04070703|144757792|SUPERIORITY||Mean Difference (Final Values)|-14.1||||0.05|TWO_SIDED|95.0|-20.0|-8.0|||Mixed Models Analysis|||||-8|-20|.05
72614097|NCT04070703|144757792|SUPERIORITY||Mean Difference (Final Values)|-22.0||||0.05|TWO_SIDED|95.0|-28.0|-16.0|||Mixed Models Analysis|||||-16|-28|.05
72327413|NCT01342926|144178480|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.18|||||TWO_SIDED|90.0|-0.66|0.29|||||6 months visit|||0.29|-0.66|
72614098|NCT04070703|144757793|SUPERIORITY||Mean Difference (Final Values)|0.1|||<|0.05|TWO_SIDED|95.0|-0.4|0.1|||Mixed Models Analysis|||||.1|-.4|<.05
72614099|NCT04070703|144757793|SUPERIORITY||Mean Difference (Final Values)|0.8|||<|0.05|TWO_SIDED|95.0|0.4|1.2|||Mixed Models Analysis|||||1.2|.4|<.05
72614100|NCT04070703|144757794|SUPERIORITY||Mean Difference (Final Values)|1.1|||<|0.05|TWO_SIDED|95.0|0.5|1.6|||Mixed Models Analysis|||||1.6|.5|<.05
72614101|NCT04070703|144757794|SUPERIORITY||Mean Difference (Final Values)|2.2|||<|0.05|TWO_SIDED|95.0|1.6|2.7|||Mixed Models Analysis|||||2.7|1.6|<.05
72614102|NCT04070703|144757795|SUPERIORITY||Mean Difference (Final Values)|0.9|||<|0.05|TWO_SIDED|95.0|-0.4|2.1|||Mixed Models Analysis|||||2.1|-.4|<.05
72614103|NCT04070703|144757795|SUPERIORITY||Mean Difference (Final Values)|4.4|||<|0.05|TWO_SIDED|95.0|3.1|5.0|||Mixed Models Analysis|||||5|3.1|<.05
72614104|NCT04070703|144757796|SUPERIORITY||Mean Difference (Final Values)|0.3|||<|0.05|TWO_SIDED|95.0|-0.3|0.7|||Mixed Models Analysis|||||.7|-.3|<.05
72614105|NCT04070703|144757796|SUPERIORITY||Mean Difference (Final Values)|-1.9|||<|0.05|TWO_SIDED|95.0|-2.4|-1.4|||Mixed Models Analysis|||||-1.4|-2.4|<.05
72614106|NCT04070703|144757797|SUPERIORITY||Mean Difference (Final Values)|-0.4|||<|0.05|TWO_SIDED|95.0|-1.4|0.4|||Mixed Models Analysis|||||.4|-1.4|<.05
72614107|NCT04070703|144757797|SUPERIORITY||Mean Difference (Final Values)|1.7|||<|0.05|TWO_SIDED|95.0|0.8|2.3|||Mixed Models Analysis|||||2.3|.8|<.05
72614108|NCT04070703|144757798|SUPERIORITY||Mean Difference (Final Values)|0.5|||<|0.05|TWO_SIDED|95.0|-0.1|1.1|||Mixed Models Analysis|||||1.1|-.1|<.05
72614109|NCT04070703|144757798|SUPERIORITY||Mean Difference (Final Values)|2.2|||<|0.05|TWO_SIDED|95.0|1.6|2.8|||Mixed Models Analysis|||||2.8|1.6|<.05
72614110|NCT04070703|144757799|SUPERIORITY||Mean Difference (Final Values)|0.1|||<|0.05|TWO_SIDED|95.0|-0.7|0.8|||Mixed Models Analysis|||||.8|-.7|<.05
72614111|NCT04070703|144757799|SUPERIORITY||Mean Difference (Final Values)|-2.2|||<|0.05|TWO_SIDED|95.0|-3.1|-1.3|||Mixed Models Analysis|||||-1.3|-3.1|<.05
72614112|NCT04070703|144757800|SUPERIORITY||Mean Difference (Final Values)|0.5|||<|0.05|TWO_SIDED|95.0|-0.3|1.2|||Mixed Models Analysis|||||1.2|-.3|<.05
72614113|NCT04070703|144757800|SUPERIORITY||Mean Difference (Final Values)|-1.0|||<|0.05|TWO_SIDED|95.0|-1.8|-0.2|||Mixed Models Analysis|||||-.2|-1.8|<.05
72327414|NCT01342926|144178480|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.28|||||TWO_SIDED|90.0|-0.19|0.75|||||12 months visit|||0.75|-0.19|
72327415|NCT01342926|144178480|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.39|||||TWO_SIDED|90.0|-0.08|0.86|||||18 months visit|||0.86|-0.08|
72327416|NCT01342926|144178488|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.14|||||TWO_SIDED|90.0|-0.34|0.61|||||6 months visit|||0.61|-0.34|
72327417|NCT01342926|144178488|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.41|||||TWO_SIDED|90.0|-0.07|0.89|||||12 months visit|||0.89|-0.07|
72327418|NCT01342926|144178488|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.42|||||TWO_SIDED|90.0|-0.06|0.89|||||18 months visit|||0.89|-0.06|
72327419|NCT01342926|144178488|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.09|||||TWO_SIDED|90.0|-0.55|0.37|||||6 months visit|||0.37|-0.55|
72327420|NCT01342926|144178488|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.33|||||TWO_SIDED|90.0|-0.13|0.8|||||12 months visit|||0.80|-0.13|
72327421|NCT01342926|144178488|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.17|||||TWO_SIDED|90.0|-0.3|0.63|||||18 months visit|||0.63|-0.30|
72327422|NCT01342926|144178488|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.13|||||TWO_SIDED|90.0|-0.31|0.57|||||6 months visit|||0.57|-0.31|
72614114|NCT04070703|144757801|SUPERIORITY||Mean Difference (Final Values)|1.4|||<|0.05|TWO_SIDED|95.0|-0.4|2.0|||Mixed Models Analysis|||||2|-.4|<.05
72614115|NCT04070703|144757801|SUPERIORITY||Mean Difference (Final Values)|5.7|||<|0.05|TWO_SIDED|95.0|3.1|7.9|||Mixed Models Analysis|||||7.9|3.1|<.05
72614116|NCT04070703|144757802|SUPERIORITY||Mean Difference (Final Values)|0.0|||<|0.05|TWO_SIDED|95.0|-0.04|0.03|||Mixed Models Analysis|||||.03|-.04|<.05
72614117|NCT04070703|144757802|SUPERIORITY||Mean Difference (Final Values)|0.07|||<|0.05|TWO_SIDED|95.0|0.03|0.11|||Mixed Models Analysis|||||.11|.03|<.05
72614118|NCT04070703|144757803|SUPERIORITY||Mean Difference (Final Values)|4.0|||<|0.05|TWO_SIDED|95.0|-2.0|6.0|||Mixed Models Analysis|||||6|-2|<.05
72614119|NCT04070703|144757803|SUPERIORITY||Mean Difference (Final Values)|125.5|||<|0.05|TWO_SIDED|95.0|84.0|166.0|||Mixed Models Analysis|||||166|84|<.05
72614120|NCT04070703|144757804|SUPERIORITY||Mean Difference (Final Values)|-0.2|||<|0.05|TWO_SIDED|95.0|-0.3|-0.1|||Mixed Models Analysis|||||-.1|-.3|<.05
72614121|NCT04070703|144757804|SUPERIORITY||Mean Difference (Final Values)|-0.5|||<|0.05|TWO_SIDED|95.0|-0.7|-0.4|||Mixed Models Analysis|||||-.4|-.7|<.05
72614122|NCT03323502|144757836|SUPERIORITY||Incidence Rate Ratio (IRR)|0.94|STANDARD_ERROR_OF_MEAN|0.062||0.3164|TWO_SIDED|95.0|0.83|1.06|||Poisson Regression|||||1.06|0.83|0.3164
72614123|NCT03323502|144757837|SUPERIORITY||Odds Ratio (OR)|0.94||||0.4828|TWO_SIDED|95.0|0.8|1.11|||Regression, Logistic|||||1.11|0.80|0.4828
72614124|NCT03323502|144757838|SUPERIORITY||Odds Ratio (OR)|1.13||||0.3946|TWO_SIDED|95.0|0.85|1.49|||Regression, Logistic|||||1.49|0.85|0.3946
72614125|NCT02612155|144757879|OTHER|||||||0.06|||||||Fisher Exact|||||||0.06
72614126|NCT00098475|144757961|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The low-dose response would be considered unacceptable if the difference in response rates was 15% or greater (the upper confidence limit exceeds the 15% acceptable difference) regardless of a decrease in toxicity rate.|Difference in response rate between arms|0.107|||||TWO_SIDED|80.0|0.052|0.162||||||The study was designed to determine if a reduced dose of dexamethasone in combination with CC-5013 reduced toxicity rate without reducing response rate. The standard-dose response was expected to be 70%. The low dose would be deemed unacceptable if the difference in response rate between arms was \>=15%. The null hypothesis was that response rates were equal and the alternative was that the low-dose response was no worse than 55%. The design had a 1-sided 0.10 type I error rate and 95% power.||0.162|0.052|
72614127|NCT02512419|144757973|SUPERIORITY||regression parameter (median diff)|37.52|STANDARD_ERROR_OF_MEAN|18.01||0.04|TWO_SIDED||||||quantile regression|Models regressed outcome at 6 months on treatment assigned, baseline value of the outcome and actigraph wear time. Effect sizes reported are adjusted|Effects are unstandardized regression coefficients. They represent difference in median outcome between conditions at 6m controlling for baseline and covariates.|To examine potential intervention effects on the primary outcome (MVPA at 6 months), we used a series of quantile regression models which model median outcome at follow-up as a function of baseline value of the outcome (MVPA), treatment condition and covariates. Note that the adjusted difference in median MVPA between conditions at follow-up will not equal the difference in median minutes as seen in the unadjusted tables as these estimates are adjusted||||.04
72614128|NCT02512419|144757974|SUPERIORITY||Median Difference (Final Values)|42.36|STANDARD_ERROR_OF_MEAN|38.83||0.1|TWO_SIDED||||||quantile regression|||Quantile regression was used.||||0.10
72614129|NCT04635423|144758030|SUPERIORITY||Observed Efficacy (%)|89.3|||<|0.001|TWO_SIDED|95.0|55.4|98.2||one-sided p-value based on exact binomial method proposed by Chan and Bohidar|Exact Binomial Method Chan and Bohidar||The statistical criterion for success requires that the lower bound of the 2-sided 95% confidence interval (CI) for vaccine efficacy (VE) against the primary efficacy endpoint is greater than 0%.|||98.2|55.4|<0.001
72614130|NCT04635423|144758031|OTHER||Difference in Percentages|40.1|||||TWO_SIDED|95.0|34.5|45.5|||Miettinen & Nurminen method||Difference in percentages calculated as % V503 minus % Placebo.|||45.5|34.5|
72614131|NCT04635423|144758032|OTHER||Difference in Percentage|0.4|||||TWO_SIDED|95.0|-4.4|5.2|||Miettinen & Nurminen method||Difference in percentages calculated as % V503 minus % Placebo.|||5.2|-4.4|
72614132|NCT04635423|144758035|SUPERIORITY||Observed Efficacy (%)|63.5||||0.023|TWO_SIDED|95.0|2.7|86.0||one-sided p-value based on exact binomial method proposed by Chan and Bohidar|Exact Binomial Method Chan and Bohidar||The statistical criterion for success requires that the lower bound of the 2-sided 95% confidence interval (CI) for vaccine efficacy (VE) against the primary efficacy endpoint is greater than 0%.|||86.0|2.7|0.023
72614133|NCT01922934|144758100|OTHER||||||<|0.001|||||||Chi-squared|||||||<0.001
72614134|NCT02354118|144758108|NON_INFERIORITY|10% non-inferiority margin||||||1|||||||Chi-squared|||||||1.0
72614135|NCT01706328|144758195|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.025||||0.137|TWO_SIDED|95.0|-0.008|0.059|||ANCOVA|||||0.059|-0.008|0.137
72614136|NCT03160170|144758198|SUPERIORITY|||||||0.96|||||||t-test, 2 sided|||||||0.96
72614137|NCT03160170|144758199|SUPERIORITY|||||||0.11|||||||t-test, 2 sided|||||||0.11
72614138|NCT03160170|144758200|SUPERIORITY|||||||0.05|||||||t-test, 2 sided|||||||0.05
72614139|NCT03018938|144758201|NON_INFERIORITY|If Lower limit (L) \>-0.4%, the Non-inferiority (NI) of basal insulin analog QD to insulin analog mid mixture BID is established; If Upper limit (U) \<0.4%, the NI of insulin analog mid mixture BID to basal insulin analog QD is established|LS Mean Difference (Final Values)|-0.158|STANDARD_ERROR_OF_MEAN|0.0959||0.1009|TWO_SIDED|95.0|-0.346|0.031|||ANCOVA|||||0.031|-0.346|0.1009
72614140|NCT03018938|144758202|SUPERIORITY||LS Mean Difference (Final Values)|-0.201|STANDARD_ERROR_OF_MEAN|0.0891||0.0246|TWO_SIDED|95.0|-0.376|-0.026|||ANCOVA|||||-0.026|-0.376|0.0246
72614141|NCT03018938|144758203|SUPERIORITY||Odds Ratio (OR)|1.34||||0.0941|TWO_SIDED|95.0|0.95|1.87|||Regression, Logistic|||||1.87|0.95|0.0941
72327423|NCT01342926|144178488|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.54|||||TWO_SIDED|90.0|0.1|0.99|||||12 months visit|||0.99|0.10|
72327424|NCT01342926|144178488|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.91|||||TWO_SIDED|90.0|0.47|1.36|||||18 months visit|||1.36|0.47|
72327425|NCT01342926|144178489|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1|||||TWO_SIDED|90.0|-0.34|0.55|||||6 months visit|||0.55|-0.34|
72327426|NCT01342926|144178489|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.45|||||TWO_SIDED|90.0|0.0|0.9|||||12 months visit|||0.90|0.00|
72327427|NCT01342926|144178489|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.33|||||TWO_SIDED|90.0|-0.12|0.77|||||18 months visit|||0.77|-0.12|
72327428|NCT01342926|144178489|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.08|||||TWO_SIDED|90.0|-0.51|0.35|||||6 months visit|||0.35|-0.51|
72327429|NCT01342926|144178489|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.23|||||TWO_SIDED|90.0|-0.21|0.66|||||12 months visit|||0.66|-0.21|
72327430|NCT01342926|144178489|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.12|||||TWO_SIDED|90.0|-0.32|0.55|||||18 months visit|||0.55|-0.32|
72327431|NCT01342926|144178489|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.06|||||TWO_SIDED|90.0|-0.48|0.35|||||6 months visit|||0.35|-0.48|
72327432|NCT01342926|144178489|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2|||||TWO_SIDED|90.0|-0.22|0.62|||||12 months visit|||0.62|-0.22|
72327433|NCT01342926|144178489|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.5|||||TWO_SIDED|90.0|0.08|0.92|||||18 months visit|||0.92|0.08|
72327434|NCT01445847|144178532|SUPERIORITY_OR_OTHER||Percentage|5.0|||<|0.05|TWO_SIDED|95.0|1.7|9.1|||Comparison of proportions|||We used incidence reported to AIMS study to calculate the sample size of this study. We set the null hypothesis as (percentage point of laryngospasm incidence in placebo group (µ1) - percentage point of laryngospasm incidence in Lidocaine group (µ2) = 0), with alternative hypothesis is (µ1 \> µ2) by 5% was analyzed by comparison of two proportions. A sample size of 380 patients (190 per group) was adequate to detect a 5-percentage point difference in the incidence with 80% power and p = 0.05.||9.1|1.7|<0.05
72327435|NCT00125788|144178533|SUPERIORITY|||||||0.076|||||||Cochran-Mantel-Haenszel|||||||0.076
72327436|NCT00125788|144178534|SUPERIORITY|||||||0.072|||||||Cochran-Mantel-Haenszel|||||||0.072
72327437|NCT00125788|144178535|SUPERIORITY|||||||0.129|||||||Cochran-Mantel-Haenszel|||||||0.129
72327438|NCT02628444|144178597|NON_INFERIORITY|The non-inferiority was demonstrated if the lower limit of the two-sided 95% confidence interval (CI) of the ratio of GMTs between groups (Group 2/Group 1) was greater than (\>) 1/2. Overall non-inferiority was demonstrated if all 4 serotypes achieved non-inferiority.|GMT Ratio|1.09|||||TWO_SIDED|95.0|0.862|1.39||||||Group 2/Group 1: Serotype 1||1.39|0.862|
72327439|NCT02628444|144178597|NON_INFERIORITY|The non-inferiority was demonstrated if the lower limit of the two-sided 95% CI of the ratio of GMTs between groups (Group 2/Group 1) was \>1/2. Overall non-inferiority was demonstrated if all 4 serotypes achieved non-inferiority.|GMT Ratio|0.993|||||TWO_SIDED|95.0|0.82|1.2||||||Group 2/Group 1: Serotype 2||1.20|0.820|
72327440|NCT02628444|144178597|NON_INFERIORITY|The non-inferiority was demonstrated if the lower limit of the two-sided 95% CI of the ratio of GMTs between groups (Group 2/Group 1) was \>1/2. Overall non-inferiority was demonstrated if all 4 serotypes achieved non-inferiority.|GMT Ratio|0.983|||||TWO_SIDED|95.0|0.816|1.18||||||Group 2/Group 1: Serotype 3||1.18|0.816|
72327441|NCT02628444|144178597|NON_INFERIORITY|The non-inferiority was demonstrated if the lower limit of the two-sided 95% CI of the ratio of GMTs between groups (Group 2/Group 1) was \>1/2. Overall non-inferiority was demonstrated if all 4 serotypes achieved non-inferiority.|GMT ratio|0.96|||||TWO_SIDED|95.0|0.809|1.14||||||Group 2/Group 1: Serotype 4||1.14|0.809|
72327442|NCT02628444|144178598|NON_INFERIORITY|The non-inferiority was demonstrated if the lower limit of the two-sided 95% CI of the ratio of GMTs between groups (Group 2/Group 1) was \>1/2. Overall non-inferiority was demonstrated if all 4 serotypes achieved non-inferiority.|GMT Ratio|1.03|||||TWO_SIDED|95.0|0.757|1.4||||||Group 2/Group 1: Serotype 1||1.40|0.757|
72327443|NCT02628444|144178598|NON_INFERIORITY|The non-inferiority was demonstrated if the lower limit of the two-sided 95% CI of the ratio of GMTs between groups (Group 2/Group 1) was \>1/2. Overall non-inferiority was demonstrated if all 4 serotypes achieved non-inferiority.|GMT Ratio|0.897|||||TWO_SIDED|95.0|0.705|1.14||||||Group 2/Group 1: Serotype 2||1.14|0.705|
72327444|NCT02628444|144178598|NON_INFERIORITY|The non-inferiority was demonstrated if the lower limit of the two-sided 95% CI of the ratio of GMTs between groups (Group 2/Group 1) was \>1/2. Overall non-inferiority was demonstrated if all 4 serotypes achieved non-inferiority.|GMT Ratio|0.917|||||TWO_SIDED|95.0|0.724|1.16||||||Group 2/Group 1: Serotype 3||1.16|0.724|
72327445|NCT02628444|144178598|NON_INFERIORITY|The non-inferiority was demonstrated if the lower limit of the two-sided 95% CI of the ratio of GMTs between groups (Group 2/Group 1) was \>1/2. Overall non-inferiority was demonstrated if all 4 serotypes achieved non-inferiority.|GMT Ratio|0.884|||||TWO_SIDED|95.0|0.72|1.09||||||Group 2/Group 1: Serotype 4||1.09|0.720|
72327446|NCT02628444|144178599|NON_INFERIORITY|The non-inferiority was demonstrated if the lower limit of the two-sided 95% CI of the ratio of GMTs within groups (Group 1a Booster/Group 1) was \>1/2. Overall non-inferiority was demonstrated if all 4 serotypes achieved non-inferiority.|GMT paired ratio|0.567|||||TWO_SIDED|98.75|0.399|0.805||||||Group 1a Booster/Group 1 Post-dose 3: Serotype 1||0.805|0.399|
72327447|NCT02628444|144178599|NON_INFERIORITY|The non-inferiority was demonstrated if the lower limit of the two-sided 95% CI of the ratio of GMTs within groups (Group 1a Booster/Group 1) was \>1/2. Overall non-inferiority was demonstrated if all 4 serotypes achieved non-inferiority.|GMT paired ratio|0.746|||||TWO_SIDED|98.75|0.55|1.01||||||Group 1a Booster/Group 1 Post-dose 3: Serotype 2||1.01|0.550|
72419774|NCT00406133|144350660|SUPERIORITY_OR_OTHER|||||||0.84||||||P-value for 15-24 year old age group.|Regression, Logistic|||||||0.84
72419775|NCT00406133|144350660|SUPERIORITY_OR_OTHER|||||||0.02||||||P-value for \>=25 year old age group.|Regression, Logistic|||||||0.02
72327448|NCT02628444|144178599|NON_INFERIORITY|The non-inferiority was demonstrated if the lower limit of the two-sided 95% CI of the ratio of GMTs within groups (Group 1a Booster/Group 1) was \>1/2. Overall non-inferiority was demonstrated if all 4 serotypes achieved non-inferiority.|GMT paired ratio|1.04|||||TWO_SIDED|98.75|0.686|1.57||||||Group 1a Booster/Group 1 Post-dose 3: Serotype 3||1.57|0.686|
72614142|NCT03018938|144758204|SUPERIORITY||Odds Ratio (OR)|1.03||||0.8592|TWO_SIDED|95.0|0.72|1.49|||Regression, Logistic|||||1.49|0.72|0.8592
72614143|NCT03018938|144758205|SUPERIORITY||LS Mean Difference (Final Values)|0.423|STANDARD_ERROR_OF_MEAN|0.2152||0.0497|TWO_SIDED|95.0|0.0|0.846|||ANCOVA|||||0.846|0.000|0.0497
72614144|NCT03018938|144758206|SUPERIORITY||LS Mean Difference (Final Values)|0.647|STANDARD_ERROR_OF_MEAN|0.1955||0.001|TWO_SIDED|95.0|0.263|1.031|||ANCOVA|||||1.031|0.263|0.0010
72614145|NCT03018938|144758207|SUPERIORITY||LS Mean Difference (Final Values)|0.27|STANDARD_ERROR_OF_MEAN|0.2191||0.2193|TWO_SIDED|95.0|-0.161|0.7|||ANCOVA|||FBG||0.700|-0.161|0.2193
72614146|NCT03018938|144758207|SUPERIORITY||LS Mean Difference (Final Values)|-0.084|STANDARD_ERROR_OF_MEAN|0.3331||0.8014|TWO_SIDED|95.0|-0.739|0.571|||ANCOVA|||PPG||0.571|-0.739|0.8014
72614147|NCT03018938|144758208|SUPERIORITY||LS Mean Difference (Final Values)|0.491|STANDARD_ERROR_OF_MEAN|0.2033||0.016|TWO_SIDED|95.0|0.092|0.891|||ANCOVA|||FBG||0.891|0.092|0.0160
72614148|NCT03018938|144758208|SUPERIORITY||LS Mean Difference (Final Values)|-0.013|STANDARD_ERROR_OF_MEAN|0.3028||0.9661|TWO_SIDED|95.0|-0.608|0.582|||ANCOVA|||PPG||0.582|-0.608|0.9661
72614149|NCT03018938|144758210|SUPERIORITY||LS Mean Difference|0.667|STANDARD_ERROR_OF_MEAN|0.2776||0.0166|TWO_SIDED|95.0|0.122|1.211|||ANCOVA|||||1.211|0.122|0.0166
72614150|NCT03018938|144758211|SUPERIORITY||LS Mean Difference (Final Values)|0.754|STANDARD_ERROR_OF_MEAN|0.2864||0.0086|TWO_SIDED|95.0|0.192|1.316|||ANCOVA|||||1.316|0.192|0.0086
72614151|NCT03018938|144758214|SUPERIORITY||Odds Ratio (OR)|1.25||||0.2009|TWO_SIDED|95.0|0.89|1.77|||Regression, Logistic|||||1.77|0.89|0.2009
72327449|NCT02628444|144178599|NON_INFERIORITY|The non-inferiority was demonstrated if the lower limit of the two-sided 95% CI of the ratio of GMTs within groups (Group 1a Booster/Group 1) was \>1/2. Overall non-inferiority was demonstrated if all 4 serotypes achieved non-inferiority.|GMT paired ratio|0.647|||||TWO_SIDED|98.75|0.434|0.963||||||Group 1a Booster/Group 1 Post-dose 3: Serotype 4||0.963|0.434|
72614152|NCT03018938|144758215|SUPERIORITY||Odds Ratio (OR)|1.05||||0.8054|TWO_SIDED|95.0|0.72|1.53|||Regression, Logistic|||||1.53|0.72|0.8054
72614153|NCT03018938|144758216|SUPERIORITY||LS Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.33||0.7553|TWO_SIDED|95.0|-0.8|0.5|||Mixed Models Analysis|||||0.5|-0.8|0.7553
72614154|NCT01769586|144758217|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.38|||<|0.001|TWO_SIDED|95.0|0.24|0.5|||Chi-squared|||||.50|.24|<0.001
72614155|NCT02811159|144758218|OTHER|||||||0.1797|||||||Chi-Square Test|||||||0.1797
72614156|NCT02811159|144758219|OTHER|||||||0.125|||||||Wilcoxon Signed-Rank Test|||||||0.1250
72614157|NCT02811159|144758220|OTHER|||||||0.25|||||||Wilcoxon Signed-Rank Test|||||||0.2500
72614158|NCT02811159|144758221|OTHER|||||||0.5|||||||Wilcoxon Signed-Rank Test|||||||0.5000
72614159|NCT02811159|144758222|OTHER|||||||0.25|||||||Wilcoxon Signed-Rank Test|||||||0.2500
72614160|NCT02811159|144758223|OTHER|||||||1|||||||Wilcoxon Signed-Rank Test|||||||1.0000
72614161|NCT02811159|144758224|OTHER|||||||0.875|||||||Wilcoxon Signed-Rank Test|||||||0.8750
72614162|NCT02811159|144758225|OTHER|||||||0.5|||||||Wilcoxon Signed-Rank Test|||||||0.5000
72614163|NCT02811159|144758226|OTHER|||||||0.5|||||||Wilcoxon Signed-Rank Test|||||||0.5000
72614164|NCT02811159|144758227|OTHER|||||||0.25|||||||Wilcoxon Signed-Rank Test|||||||0.2500
72614165|NCT02811159|144758228|OTHER|||||||0.0645|||||||Wilcoxon Signed-Rank Test|||||||0.0645
72614166|NCT00191100|144758230|SUPERIORITY_OR_OTHER||PFS Probability Difference at 3 Years|0.095||||0.029||95.0|0.01|0.179||The p-value is two-sided and was tested at the 0.05 significance level.|Z Statistic||Difference in progression-free survival probability between Gem/Cis/Rad and Cis/Rad. The difference in PFS probability between the two treatment arms can also be presented as a percentage (ie, PFS at 3 years was 9.5% better in the Gem/Cis/Rad arm).|||0.179|0.010|0.029
72614167|NCT00191100|144758231|SUPERIORITY_OR_OTHER|||||||0.0008||95.0|||||Log Rank|||||||0.0008
72614168|NCT00191100|144758232|SUPERIORITY_OR_OTHER|||||||0.096||95.0||||The p-value is two-sided and was tested at the 0.05 significance level.|Fisher Exact|||"Note: There were 2 patients with unknown site of progressive disease; these patients were counted as a Local failure.~Note: There was 1 patient with both local and distant failure; this patient was counted as a Local failure."||||0.096
72614169|NCT00191100|144758233|SUPERIORITY_OR_OTHER|||||||0.25||95.0||||The p-value is two-sided and was tested at the 0.05 significance level.|Fisher Exact|||||||0.250
72614170|NCT00191100|144758234|SUPERIORITY_OR_OTHER|||||||0.0224||95.0|||||Log Rank|||||||0.0224
72614171|NCT00191100|144758235|SUPERIORITY_OR_OTHER|||||||0.0227||95.0|||||Log Rank|||||||0.0227
72614172|NCT01525589|144758248|SUPERIORITY|||||||0.0909|||||||Log Rank|||||||0.0909
72614173|NCT01525589|144758252|SUPERIORITY|||||||0.002|||||||Log Rank|||||||0.002
72614174|NCT01525589|144758256|SUPERIORITY|||||||0.0561|||||||Log Rank|||||||0.0561
72614175|NCT00975923|144758282|SUPERIORITY_OR_OTHER||infection rates per device days|2.0|STANDARD_ERROR_OF_MEAN|0.05|<|0.05|TWO_SIDED|95.0|1.0|3.0||p-value and confidence intervals|Regression, Linear|||Infection rates were analyzed using hierarchical negative binomial regression models to model infection rate changes over time and account for clustering of ICUs within hospitals and adjusting for baseline covariates. Power was calculated a priori with a 1-tailed alpha of 0.05 and group size of 30; a 50% decrease in infection rates in the Collaborative group and 15% for the Tool Kit group, yielding power ranging from 82% to 91% for testing group differences.||3.0|1.0|<.05
72614176|NCT00975923|144758283|SUPERIORITY_OR_OTHER||percentages|10.0|||<|5|TWO_SIDED|95.0|||||Chi-squared||Power calculation used alpha = .05 and group size = 30.The estimated effect was a 50% decrease in infection rates for the Collaborative Group and from 10% to 15% decrease in the Tool Kit group.Power ranged from 82%-91% for testing group differences.|It was hypothesized that the Collaborative group would engage in more processes and tools than the Tool Kit group. Power was based on infection rates.||||<05
72614177|NCT00373672|144758307|SUPERIORITY||||||<|0.016|||||||t-test, 2 sided|||Treatment effects were analyzed using a repeated measures analysis of variance model with time (baseline, 6 weeks) as the within-subjects factor and treatment group (armodafinil, placebo) as the between-subjects factor.||||<0.016
72614178|NCT04871074|144758308|SUPERIORITY|||||||0.74|||||||DeLong's Test|||||||.74
72327450|NCT02628444|144178600|NON_INFERIORITY|The non-inferiority was demonstrated if the lower limit of the two-sided Bonferroni corrected 95% CI for the ratio of GMTs between groups (Group 2a Booster/Group 1) was \>1/2. Overall non-inferiority was demonstrated if all 4 serotypes achieved non-inferiority.|GMT Ratio|0.627|||||TWO_SIDED|98.75|0.342|1.15||||||Group 2a Booster dose/Group 1 Post-dose 3: Serotype 1||1.15|0.342|
72327451|NCT02628444|144178600|NON_INFERIORITY|The non-inferiority was demonstrated if the lower limit of the two-sided Bonferroni corrected 95% CI for the ratio of GMTs between groups (Group 2a Booster/Group 1) was \>1/2. Overall non-inferiority was demonstrated if all 4 serotypes achieved non-inferiority.|GMT Ratio|0.809|||||TWO_SIDED|98.75|0.505|1.3||||||Group 2a Booster/Group 1 Post-dose 3: Serotype 2||1.30|0.505|
72327452|NCT02628444|144178600|NON_INFERIORITY|The non-inferiority was demonstrated if the lower limit of the two-sided Bonferroni corrected 95% CI for the ratio of GMTs between groups (Group 2a Booster/Group 1) was \>1/2. Overall non-inferiority was demonstrated if all 4 serotypes achieved non-inferiority.|GMT Ratio|1.19|||||TWO_SIDED|98.75|0.732|1.94||||||Group 2a Booster/Group 1 Post-dose 3: Serotype 3||1.94|0.732|
72327453|NCT02628444|144178600|NON_INFERIORITY|The non-inferiority was demonstrated if the lower limit of the two-sided Bonferroni corrected 95% CI for the ratio of GMTs between groups (Group 2a Booster/Group 1) was \>1/2. Overall non-inferiority was demonstrated if all 4 serotypes achieved non-inferiority.|GMT Ratio|0.499|||||TWO_SIDED|98.75|0.331|0.754||||||Group 2a Booster/Group 1 Post-dose 3: Serotype 4||0.754|0.331|
72327454|NCT02628444|144178601|NON_INFERIORITY|The non-inferiority was demonstrated if the lower limit of the two-sided 95% CI of the ratio of GMTs within groups (Group 1b booster/Group 1) was \>1/2. Overall non-inferiority was demonstrated if all 4 serotypes achieved non-inferiority.|GMT paired ratio|0.688|||||TWO_SIDED|98.75|0.479|0.989||||||Group 1b Booster/Group 1 Post-dose 3: Serotype 1||0.989|0.479|
72327455|NCT02628444|144178601|NON_INFERIORITY|The non-inferiority was demonstrated if the lower limit of the two-sided 95% CI of the ratio of GMTs within groups (Group 1b booster/Group 1) was \>1/2. Overall non-inferiority was demonstrated if all 4 serotypes achieved non-inferiority.|GMT paired ratio|0.871|||||TWO_SIDED|98.75|0.673|1.13||||||Group 1b Booster/Group 1 Post-dose 3: Serotype 2||1.13|0.673|
72327456|NCT02628444|144178601|NON_INFERIORITY|The non-inferiority was demonstrated if the lower limit of the two-sided 95% CI of the ratio of GMTs within groups (Group 1b booster/Group 1) was \>1/2. Overall non-inferiority was demonstrated if all 4 serotypes achieved non-inferiority.|GMT paired ratio|1.15|||||TWO_SIDED|98.75|0.887|1.49||||||Group 1b Booster/Group 1 Post-dose 3: Serotype 3||1.49|0.887|
72327457|NCT02628444|144178601|NON_INFERIORITY|The non-inferiority was demonstrated if the lower limit of the two-sided 95% CI of the ratio of GMTs within groups (Group 1b booster/Group 1) was \>1/2. Overall non-inferiority was demonstrated if all 4 serotypes achieved non-inferiority.|GMT paired ratio|0.655|||||TWO_SIDED|98.75|0.471|0.911||||||Group 1b Booster/Group 1 Post-dose 3: Serotype 4||0.911|0.471|
72327458|NCT02628444|144178602|NON_INFERIORITY|The non-inferiority was demonstrated if the lower limit of the two-sided 95% CI of the ratio of GMTs between groups (Group 2b Booster/Group 1) was \>1/2. Overall non-inferiority was demonstrated if all 4 serotypes achieved non-inferiority.|GMT ratio|0.889|||||TWO_SIDED|98.75|0.462|1.71||||||Group 2b Booster/Group 1 Post-dose 3: Serotype 1||1.71|0.462|
72327459|NCT02628444|144178602|NON_INFERIORITY|The non-inferiority was demonstrated if the lower limit of the two-sided 95% CI of the ratio of GMTs between groups (Group 2b Booster/Group 1) was \>1/2. Overall non-inferiority was demonstrated if all 4 serotypes achieved non-inferiority.|GMT ratio|0.677|||||TWO_SIDED|98.75|0.402|1.14||||||Group 2b Booster/Group 1 Post-dose 3: Serotype 2||1.14|0.402|
72419776|NCT00406133|144350661|SUPERIORITY_OR_OTHER|||||||0.01||||||P-value for 8-14 year age group|Regression, Logistic|||Within each age group, in addition to the primary ANCOVA analysis, pre-specified 26-week binary glycated hemoglobin outcomes (relative decrease by \>=10%, 26-week level \<7.0%, absolute decrease by \>=0.5%, relative increase by \>=10%, absolute increase by \>=0.5%) were evaluated in logistic regression models, adjusted for baseline glycated hemoglobin level and clinical center.||||0.01
72419777|NCT00406133|144350661|SUPERIORITY_OR_OTHER|||||||0.8||||||P-value for 14-24 year age group|Regression, Logistic|||||||0.80
72419778|NCT00406133|144350661|SUPERIORITY_OR_OTHER|||||||0.005||||||P-value for \>=25 year age group|Regression, Logistic|||||||0.005
72419779|NCT00406133|144350662|SUPERIORITY_OR_OTHER|||||||0.02||||||P-value for the 8-14 year age group|Regression, Logistic|||A post-hoc defined binary outcome of 26-week glycated hemoglobin \<7.0% with no severe hypoglycemic events was analyzed in logistic regression models, adjusted for baseline glycated hemoglobin level and clinical center.||||0.02
72419780|NCT00406133|144350662|SUPERIORITY_OR_OTHER|||||||0.67||||||P-value for the 15-24 year old age group|Regression, Logistic|||||||0.67
72419781|NCT00406133|144350662|SUPERIORITY_OR_OTHER|||||||0.006||||||P-value for the \>=25 year old age group|Regression, Logistic|||||||0.006
72614179|NCT04871074|144758309|SUPERIORITY|||||||0.66|||||||DeLong's Test|||||||.66
72614180|NCT04871074|144758310|SUPERIORITY|||||||0.135|||||||Mixed Models Analysis|Linear mixed effects model, fixed effects coefficient test with a Wald test||||||.135
72614181|NCT04871074|144758314|SUPERIORITY|||||||0.39|||||||Mixed Models Analysis|Fixed effects estimate, Wald test||||||.39
72614182|NCT06354257|144758327|EQUIVALENCE|The 90% CI for each ratio was compared to 0.8 and 1.25.|Geometric mean ratio|0.88|||||TWO_SIDED|90.0|0.55|1.41|||Mixed Models Analysis|Analysis was performed using linear mixed effect models with treatment as a fixed effect and subject as a random effect.|One-sided tests (alpha=0.05) were used. 90% CIs for each ratio were compared to 0.8-1.25. No drug interaction is shown if CIs for AUC(0-inf) and Cmax of EE and LNG fall within 0.8-1.25.|A confirmatory hypothesis testing to test the effect of GSK3036656 on the AUC(0-inf) of EE.||1.41|0.55|
72614183|NCT06354257|144758327|EQUIVALENCE|The 90% CI for each ratio was compared to 0.8 and 1.25.|Geometric mean ratio|1.1|||||TWO_SIDED|90.0|0.98|1.23|||Mixed Models Analysis|Analysis was performed using linear mixed effect models with treatment as a fixed effect and subject as a random effect.|One-sided tests (alpha=0.05) were used. 90% CIs for each ratio were compared to 0.8-1.25. No drug interaction is shown if CIs for AUC(0-inf) and Cmax of EE and LNG fall within 0.8-1.25.|A confirmatory hypothesis testing to test the effect of GSK3036656 on the AUC(0-inf) of LNG.||1.23|0.98|
72614184|NCT06354257|144758328|EQUIVALENCE|The 90% CI for each ratio was compared to 0.8 and 1.25.|Geometric mean ratio|0.96|||||TWO_SIDED|90.0|0.85|1.09|||Mixed Models Analysis|Analysis was performed using linear mixed effect models with treatment as a fixed effect and subject as a random effect.|One-sided tests (alpha=0.05) were used. 90% CIs for each ratio were compared to 0.8-1.25. No drug interaction is shown if CIs for AUC(0-inf) and Cmax of EE and LNG fall within 0.8-1.25.|A confirmatory hypothesis testing to test the effect of GSK3036656 on the Cmax of EE.||1.09|0.85|
72614185|NCT06354257|144758328|EQUIVALENCE|The 90% CI for each ratio was compared to 0.8 and 1.25.|Geometric mean ratio|1.08|||||TWO_SIDED|90.0|0.97|1.19|||Mixed Models Analysis|Analysis was performed using linear mixed effect models with treatment as a fixed effect and subject as a random effect.|One-sided tests (alpha=0.05) were used. 90% CIs for each ratio were compared to 0.8-1.25. No drug interaction is shown if CIs for AUC(0-inf) and Cmax of EE and LNG fall within 0.8-1.25.|A confirmatory hypothesis testing to test the effect of GSK3036656 on the Cmax of LNG.||1.19|0.97|
72614186|NCT04132050|144758345|SUPERIORITY||Difference in Percent of Participants|36.4||||0.03|TWO_SIDED|95.0|3.1|59.3|||Fisher Exact||"The difference in the achievement rate of Stable platelet response (= platelet count of ≥ 50000/μL at 4 or more of the 6 visits from Weeks 14 to 24) between two groups and its two-sided 95% CI were calculated."|||59.3|3.1|0.030
72614187|NCT00843882|144758358|SUPERIORITY|||||||0.004|||||||Fisher Exact|||||||0.004
72614188|NCT00843882|144758367|SUPERIORITY|||||||0.0002|||||||Wilcoxon (Mann-Whitney)|||||||0.0002
72614189|NCT05317546|144758371|SUPERIORITY|We used linear mixed effects models containing the main effect of medication (CBD vs. placebo), visit (visit 1 vs. visit 2), and sequence (CBD/placebo vs. placebo/CBD) with random intercepts. For 1H-MRS models, brain tissue composition \[Gray Matter: Brain Matter or GM:BM defined as GM/(GM+WM)\] was included as a covariate.||||||0.33||||||alpha \< 0.05|Mixed Models Analysis|Adjusted for brain tissue composition||An a priori power analysis was conducted to ensure power to detect differences in neurometabolite levels in the dACC. Due to type of modeling, participants were included even if they did not complete the second medication allocation.||||0.33
72614190|NCT05317546|144758372|SUPERIORITY|We used linear mixed effects models containing the main effect of medication (CBD vs. placebo), visit (visit 1 vs. visit 2), and sequence (CBD/placebo vs. placebo/CBD) with random intercepts. For 1H-MRS models, brain tissue composition \[Gray Matter: Brain Matter or GM:BM defined as GM/(GM+WM)\] was included as a covariate.||||||0.75||||||alpha \<0.05|Mixed Models Analysis|Adjusted for brain tissue composition||Due to type of modeling, participants were included even if they did not complete the second medication allocation.||||0.75
72614191|NCT05317546|144758373|SUPERIORITY||||||>|0.05|||||||Mixed Models Analysis|||Several studies have demonstrated that CBD can modulate resting-state or task-based BOLD signal under similar study design (acute dosing, 600 mg CBD) with sample sizes smaller than our sample. Due to the modeling, only participants with usable data from both medication allocation visits were included. Contrast of interest was alcohol beverages vs. non-alcohol beverages.||||>0.05
72614192|NCT05317546|144758374|SUPERIORITY|||||||0.82|||||||Mixed Models Analysis|||We were not able to complete a power calculation for this task. We used linear mixed effects models, containing the main effect of medication (CBD vs. placebo), visit (visit 1 vs. visit 2), and sequence (CBD/placebo vs. placebo/CBD) and cue-by-medication interaction terms. Random intercepts were included to account for individual differences.||||0.82
72614193|NCT05317546|144758375|SUPERIORITY|||||||0.21|||||||Mixed Models Analysis|||We were not able to complete a power calculation for this task. We used linear mixed effects models, containing the main effect of medication (CBD vs. placebo), visit (visit 1 vs. visit 2), and sequence (CBD/placebo vs. placebo/CBD) and cue-by-medication interaction terms. Random intercepts were included to account for individual differences.||||0.21
72614194|NCT04590963|144758380|SUPERIORITY||Hazard Ratio (HR)|1.0||||0.989|TWO_SIDED|95.0|0.66|1.537|||Log Rank|P-value was calculated using stratified log-rank test, adjusted for WHO/ECOG PS (0/1) and number of prior lines of therapy in R/M setting.|HR and CIs were calculated using a stratified Cox proportional hazards model, adjusted for WHO/ECOG PS, and number of lines of prior therapy in R/M setting.|||1.537|0.660|0.989
72614195|NCT04590963|144758381|SUPERIORITY||Hazard Ratio (HR)|1.03||||0.891|TWO_SIDED|95.0|0.704|1.528|||Log Rank|P-value was calculated using stratified log-rank test, adjusted for HPV status, WHO/ECOG PS (0/1) and number of prior lines of therapy in R/M setting.|HR and CIs were calculated using a stratified Cox proportional hazards model, adjusted for HPV status, WHO/ECOG PS, and number of lines of prior therapy in R/M setting.|||1.528|0.704|0.891
72614196|NCT04590963|144758382|SUPERIORITY||Hazard Ratio (HR)|1.11||||0.574|TWO_SIDED|95.0|0.79|1.568|||Log Rank|P-value was calculated using stratified log-rank test, adjusted for WHO/ECOG PS (0/1) and number of prior lines of therapy in R/M setting.|HR and CIs were calculated using a stratified Cox proportional hazards model, adjusted for WHO/ECOG PS, and number of lines of prior therapy in R/M setting.|||1.568|0.790|0.574
72614197|NCT04590963|144758383|SUPERIORITY||Hazard Ratio (HR)|1.11||||0.53|TWO_SIDED|95.0|0.818|1.512|||Log Rank|P-value was calculated using stratified log-rank test, adjusted for HPV status, WHO/ECOG PS (0/1) and number of prior lines of therapy in R/M setting.|HR and CIs were calculated using a stratified Cox proportional hazards model, adjusted for HPV status, WHO/ECOG PS, and number of lines of prior therapy in R/M setting.|||1.512|0.818|0.530
72614198|NCT04590963|144758384|SUPERIORITY||Odds Ratio (OR)|0.56||||0.115|TWO_SIDED|95.0|0.274|1.154|||Regression, Logistic|P-value is based on twice the change in log-likelihood resulting from the addition of a treatment factor to the model.|The analysis was performed using a logistic regression model, with treatment as a covariate and adjusting for WHO/ECOG PS, and number of lines of prior therapy in the R/M setting with 95% CI calculated by profile likelihood.|||1.154|0.274|0.115
72614199|NCT04590963|144758385|SUPERIORITY||Odds Ratio (OR)|0.6||||0.162|TWO_SIDED|95.0|0.297|1.231|||Regression, Logistic|P-value is based on twice the change in log-likelihood resulting from the addition of a treatment factor to the model.|The analysis was performed using a logistic regression model, with treatment as a covariate and adjusting for HPV Status, WHO/ECOG PS, and number of lines of prior therapy in the R/M setting with 95% CI calculated by profile likelihood.|||1.231|0.297|0.162
72614200|NCT04738487|144758396|SUPERIORITY||Hazard Ratio (HR)|1.06||||0.6712|TWO_SIDED|95.0|0.83|1.35||One-sided p-value based on log-rank test.|Log Rank||Based on Cox regression model with Efron's method of tie handling with treatment as a covariate.|||1.35|0.83|0.6712
72614201|NCT04738487|144758397|SUPERIORITY||Hazard Ratio (HR)|0.96||||0.332|TWO_SIDED|95.0|0.82|1.13||One-sided p-value based on log-rank test.|Log Rank||Based on Cox regression model with Efron's method of tie handling with treatment as a covariate.|||1.13|0.82|0.3320
72614202|NCT04738487|144758398|SUPERIORITY||Hazard Ratio (HR)|0.9||||0.1646|TWO_SIDED|95.0|0.72|1.11||One-sided p-value based on log-rank test.|Log Rank||Based on Cox regression model with Efron's method of tie handling with treatment as a covariate.|||1.11|0.72|0.1646
72614203|NCT03976375|144758446|SUPERIORITY||Hazard Ratio (HR)|0.98||||0.4342|TWO_SIDED|95.0|0.78|1.23||Stratified by Baseline ECOG performance status (0 versus 1), anti-PD-1/PD-L1 mAb (immediate prior therapy versus not the immediate prior therapy), and Baseline PD-L1 Status (\<50% versus \>=50)|Log Rank||Based on stratified Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by Baseline ECOG performance status, anti-PD-1/PD-L1 mAb therapy, and Baseline PD-L1 Status|||1.23|0.78|0.4342
72614204|NCT03976375|144758447|SUPERIORITY||Hazard Ratio (HR)|0.89||||0.1563|TWO_SIDED|95.0|0.7|1.12||Stratified by Baseline ECOG performance status (0 versus 1), anti-PD-1/PD-L1 mAb (immediate prior therapy versus not the immediate prior therapy), and Baseline PD-L1 Status (\<50% versus \>=50)|Log Rank||Based on stratified Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by Baseline ECOG performance status, anti-PD-1/PD-L1 mAb therapy, and Baseline PD-L1 Status.|||1.12|0.70|0.1563
72327460|NCT02628444|144178602|NON_INFERIORITY|The non-inferiority was demonstrated if the lower limit of the two-sided 95% CI of the ratio of GMTs between groups (Group 2b Booster/Group 1) was \>1/2. Overall non-inferiority was demonstrated if all 4 serotypes achieved non-inferiority.|GMT ratio|0.911|||||TWO_SIDED|98.75|0.573|1.45||||||Group 2b Booster/Group 1 Post-dose 3: Serotype 3||1.45|0.573|
72327461|NCT02628444|144178602|NON_INFERIORITY|The non-inferiority was demonstrated if the lower limit of the two-sided 95% CI of the ratio of GMTs between groups (Group 2b Booster/Group 1) was \>1/2. Overall non-inferiority was demonstrated if all 4 serotypes achieved non-inferiority.|GMT ratio|0.702|||||TWO_SIDED|98.75|0.447|1.1||||||Group 2b Booster/Group 1 Post-dose 3: Serotype 4||1.10|0.447|
72614205|NCT03976375|144758448|SUPERIORITY||Difference in Percentage vs Docetaxel|8.4||||0.01818|TWO_SIDED|95.0|0.5|16.3||One-sided p-value for testing. H0: difference in % =0 versus H1: difference in % \> 0.|Miettinen and Nurminen method||Based on Miettinen \& Nurminen method stratified by Baseline ECOG performance status (0 versus 1), anti-PD-1/PD-L1 mAb (immediate prior therapy versus not the immediate prior therapy), and Baseline PD-L1 Status (\<50% versus \>=50%)|||16.3|0.5|0.01818
72614206|NCT03976375|144758449|SUPERIORITY||Difference in Percentage vs Lenvatinib|10.2||||0.06009|TWO_SIDED|95.0|-3.1|19.9||One-sided p-value for testing. H0: difference in % =0 versus H1: difference in % \> 0.|Miettinen & Nurminen method|||||19.9|-3.1|0.06009
72614207|NCT03976375|144758453|OTHER||Difference in least squares means|-1.36||||0.4998|TWO_SIDED|95.0|-5.32|2.6|||t-test, 2 sided||Based on cLDA model with covariates for treatment by time interaction, stratification factors of baseline ECOG performance status, anti-PD-1/PD-L1 mAb therapy, and baseline PD-L1 Status|||2.60|-5.32|0.4998
72614208|NCT03976375|144758454|OTHER||Difference in Least Squares Mean|-3.86||||0.1531|TWO_SIDED|95.0|-9.16|1.44|||t-test, 2 sided||Based on cLDA model with covariates for treatment by time interaction, stratification factors of baseline ECOG performance status, anti-PD-1/PD-L1 mAb therapy, and baseline PD-L1 Status|||1.44|-9.16|0.1531
72614209|NCT03976375|144758455|OTHER||Difference in Least Squares Means|2.48||||0.3084|TWO_SIDED|95.0|-2.31|7.27|||t-test, 2 sided||Based on cLDA model with covariates for treatment by time interaction, stratification factors of baseline ECOG performance status, timing of anti-PD-1/PD-L1 mAb therapy, and baseline PD-L1 Status|||7.27|-2.31|0.3084
72614210|NCT03976375|144758456|OTHER||Difference in Least Squares Means|-8.04||||0.0058|TWO_SIDED|95.0|-13.73|-2.35|||t-test, 2 sided||Based on cLDA model with covariates for treatment by time interaction, stratification factors of baseline ECOG performance status, anti-PD-1/PD-L1 mAb therapy, and baseline PD-L1 Status|||-2.35|-13.73|0.0058
72614211|NCT03976375|144758457|OTHER||Difference in Least Squares Means|2.89||||0.1681|TWO_SIDED|95.0|-1.23|7.01|||t-test, 2 sided||Based on cLDA model with covariates for treatment by time interaction, stratification factors of baseline ECOG performance status, anti-PD-1/PD-L1 mAb therapy, and baseline PD-L1 Status|||7.01|-1.23|0.1681
72614212|NCT03976375|144758458|OTHER||Hazard Ratio (HR)|0.91||||0.6145|TWO_SIDED|95.0|0.63|1.31||stratified by Baseline ECOG performance status, anti-PD-1/PD-L1 mAb therapy, and Baseline PD-L1 Status.|Log Rank||Based on stratified Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by Baseline ECOG performance status, anti-PD-1/PD-L1 mAb therapy, and Baseline PD-L1 Status.|||1.31|0.63|0.6145
72614213|NCT03976375|144758459|OTHER||Hazard Ratio (HR)|0.61||||0.0398|TWO_SIDED|95.0|0.38|0.98|||Log Rank|Stratified by Baseline ECOG performance status, anti-PD-1/PD-L1 mAb therapy, and Baseline PD-L1 Status.|Based on stratified Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by Baseline ECOG performance status, anti-PD-1/PD-L1 mAb therapy, and Baseline PD-L1 Status.|||0.98|0.38|0.0398
72614214|NCT03976375|144758460|OTHER||Hazard Ratio (HR)|1.05||||0.8724|TWO_SIDED|95.0|0.59|1.85|||Log Rank|Stratified by Baseline ECOG performance status, anti-PD-1/PD-L1 mAb therapy, and Baseline PD-L1 Status.|Based on stratified Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by Baseline ECOG performance status, anti-PD-1/PD-L1 mAb therapy, and Baseline PD-L1 Status|||1.85|0.59|0.8724
72614215|NCT03976375|144758461|OTHER||Hazard Ratio (HR)|0.75||||0.1944|TWO_SIDED|95.0|0.49|1.16||Stratified by Baseline ECOG performance status, anti-PD-1/PD-L1 mAb therapy, and Baseline PD-L1 Status.|Log Rank||Based on stratified Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by Baseline ECOG performance status, anti-PD-1/PD-L1 mAb therapy, and Baseline PD-L1 Status.|||1.16|0.49|0.1944
72614216|NCT03976375|144758462|OTHER||Hazard Ratio (HR)|1.0||||0.9837|TWO_SIDED|95.0|0.71|1.41|||Log Rank|Stratified by Baseline ECOG performance status, anti-PD-1/PD-L1 mAb therapy, and Baseline PD-L1 Status.|Based on stratified Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by Baseline ECOG performance status, anti-PD-1/PD-L1 mAb therapy, and Baseline PD-L1 Status.|||1.41|0.71|0.9837
72614217|NCT03976375|144758463|OTHER||Hazard Ratio (HR)|0.84||||0.2903|TWO_SIDED|95.0|0.6|1.16|||Log Rank|Stratified by Baseline ECOG performance status, anti-PD-1/PD-L1 mAb therapy, and Baseline PD-L1 Status.|Based on stratified Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by Baseline ECOG performance status, anti-PD-1/PD-L1 mAb therapy, and Baseline PD-L1 Status.|||1.16|0.60|0.2903
72614218|NCT01063114|144758464|OTHER||3-Year Cumulative incidence|26.0|||||TWO_SIDED|95.0|16.0|37.0||||||||37|16|
72614219|NCT01063114|144758464|OTHER||5-Year Cumulative incidence|27.0|||||TWO_SIDED|95.0|17.0|38.0||||||||38|17|
72614220|NCT01063114|144758465|OTHER||3-Year Cumulative incidence|46.0|||||TWO_SIDED|95.0|34.0|57.0||||||||57|34|
72614221|NCT01063114|144758465|OTHER||5-Year Cumulative incidence|67.0|||||TWO_SIDED|95.0|54.0|77.0||||||||77|54|
72614222|NCT01063114|144758466|OTHER||Mean Difference (Net)|-11.0||||0.01024|TWO_SIDED|95.0|-19.2|-2.9|||t-test, 2 sided|Paired t test||||-2.9|-19.2|0.01024
72614223|NCT01063114|144758467|OTHER||3-Year Survival Probability|83.2|||||TWO_SIDED|95.0|75.8|91.3||||||||91.3|75.8|
72614224|NCT01063114|144758467|OTHER||5-Year Survival Probability|79.6|||||TWO_SIDED|95.0|71.7|88.5||||||||88.5|71.7|
72614225|NCT03409367|144758517|EQUIVALENCE|The risk ratio is equal to 1.|Risk Ratio (RR)|0.84||||0.019|TWO_SIDED|95.0|0.73|0.97|||Regression, log-binomial||Adjusted for family history of atopy (stratified randomization) and primary care site. Adjusted for multiple imputations.|The null hypothesis is that the cumulative incidence of atopic dermatitis does not differ between the Daily Emollient and Natural Skin arms, or that the risk ratio is equal to 1.||0.97|0.73|0.019
72614226|NCT03409367|144758518|EQUIVALENCE|The risk ratio (RR) is equal to 1.|Risk Ratio (RR)|0.76||||0.002|TWO_SIDED|95.0|0.65|0.9|||Regression, log-binomial|Adjusted for family history of atopy (stratified randomization) and primary care site. Adjusted for multiple imputations.||The null hypothesis is that the cumulative incidence of parent-reported AD does not differ between the Daily Emollient and Natural Skin arms, or that the risk ratio (RR) is equal to 1.||0.90|0.65|0.002
72614227|NCT03409367|144758519|EQUIVALENCE|Risk ratio is equal to 1.|Risk Ratio (RR)|0.86||||0.323|TWO_SIDED|95.0|0.65|1.15||Adjusted for family history of atopy (stratified randomization) and primary care site. Adjusted for multiple imputations.|Regression, log-binomial|||The null hypothesis is that the cumulative incidence of AD by modified UK Working Party criteria does not differ between the Daily Emollient and Natural Skin arms, or that the risk ratio (RR) is equal to 1.||1.15|0.65|0.323
72614228|NCT03409367|144758520|EQUIVALENCE|Risk ratio is equal to 1.|Risk Ratio (RR)|0.83||||0.044|TWO_SIDED|95.0|0.7|0.99|||Regression, log-binomial|Adjusted for family history of atopy (stratified randomization) and primary care site. Adjusted for multiple imputations.||The null hypothesis is that the cumulative incidence of AD by CEQ does not differ between the Daily Emollient and Natural Skin arms, or that the risk ratio (RR) is equal to 1.||0.99|0.70|0.044
72614229|NCT03409367|144758521|EQUIVALENCE|The risk ratio (RR) is equal to 1.|Risk Ratio (RR)|0.68||||0.0004|TWO_SIDED|95.0|0.55|0.84|||Regression, log-binomial|Adjusted for family history of atopy (stratified randomization) and primary care site. Adjusted for multiple imputations.||The null hypothesis is that the cumulative incidence of AD with prescription or OTC therapies in the health record does not differ between the Daily Emollient and Natural Skin arms, or that the risk ratio (RR) is equal to 1.||0.84|0.55|0.0004
72614230|NCT03409367|144758522|EQUIVALENCE|The odds ratio (OR) is equal to 1. An OR \< 1 could be considered evidence that daily emollient use is associated with lower severity of AD, as operationalized here by the type of recommended treatment.|Odds Ratio (OR)|0.7||||0.004|TWO_SIDED|95.0|0.55|0.89||Adjusted for family history of atopy (stratified randomization) and primary care site. Adjusted for multiple imputations of 199 missing outcomes.|Regression, proportional odds|||The null hypothesis is that the odds of belonging to the next higher category of severity are equal in the Daily Emollient and Natural Skin arms.||0.89|0.55|0.004
72614231|NCT03409367|144758523|EQUIVALENCE|Odds ratio (OR) is equal to 1. An OR \< 1 could be considered evidence that daily emollient use is associated with lower severity of AD, as operationalized here by the type of treatment.|Odds Ratio (OR)|0.72||||0.013|TWO_SIDED|95.0|0.56|0.93|||Regression, proportional odds|Adjusted for family history of atopy (stratified randomization) and primary care site.||The null hypothesis is that the odds of belonging to the next higher category of severity are equal in the Daily Emollient and Natural Skin arms.||0.93|0.56|0.013
72614232|NCT03409367|144758524|EQUIVALENCE|The risk ratio (RR) is equal to 1.|Risk Ratio (RR)|0.92||||0.509|TWO_SIDED|95.0|0.73|1.17|||Regression, log-binomial|Adjusted for family history of atopy (stratified randomization) and primary care site.||The null hypothesis is that the cumulative incidence of skin infections in the health record does not differ between the Daily Emollient and Natural Skin arms.||1.17|0.73|0.509
72614233|NCT03409367|144758525|EQUIVALENCE|The risk ratio is equal to 1.|Risk Ratio (RR)|1.05||||0.9|TWO_SIDED|95.0|0.5|2.18|||Regression, log-binomial|Adjusted for family history of atopy (stratified randomization) and primary care site.||The null hypothesis is that the cumulative incidence of asthma in the health record does not differ between the Daily Emollient and Natural Skin arms, or that the risk ratio (RR) is equal to 1.||2.18|0.50|0.900
72614234|NCT03409367|144758526|EQUIVALENCE|An ordinal OR \< 1 could be considered evidence that daily emollient use is associated with lower severity of AD symptoms among those diagnosed with AD.|Odds Ratio (OR)|1.47||||0.064|TWO_SIDED|95.0|0.98|2.21|||Regression, proportional odds|Adjusted for family history of atopy (stratified randomization).|The daily emollient is in the numerator and the natural skin is in the denominator.|The null hypothesis is that the odds of belonging to the next higher category of severity are equal in the Daily Emollient and Natural Skin arms, or that the ordinal odds ratio (OR) is equal to 1.||2.21|0.98|0.064
72614235|NCT03409367|144758527|EQUIVALENCE|An ordinal OR \< 1 could be considered evidence that daily emollient use is associated with lower severity of AD symptoms among those diagnosed with AD.|Odds Ratio (OR)|1.62||||0.007|TWO_SIDED|95.0|1.14|2.3|||Regression, proportional odds|Adjusted for family history of atopy (stratified randomization).|Daily emollient in the numerator and natural skin in the denominator.|The null hypothesis is that the odds of belonging to the next higher category of severity are equal in the Daily Emollient and Natural Skin arms, or that the ordinal odds ratio (OR) is equal to 1.||2.30|1.14|0.007
72327462|NCT02628444|144178603|SUPERIORITY|The superiority was demonstrated if the lower limit of the two-sided 95% CI was greater than 1 between groups (Group 2/Group 1). Overall superiority of Group 2 to Group 1 was demonstrated if individual serotype null hypotheses were rejected.|GMT Ratio|1.05|||||TWO_SIDED|95.0|0.833|1.33||||||Group2/Group1: Serotype 1 (28 days after last vaccination)||1.33|0.833|
72419782|NCT00406133|144350663|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Regression, Logistic|||Other preplanned secondary outcomes included change in A1c from baseline to 26 weeks in an ANCOVA model (adjusted for baseline A1c and clinical center) and 26-week binary A1c outcomes (decrease and increase in A1C from baseline by \>=0.3% and 26-week value \<7.0%) evaluated similarly using logistic regression models.||||<0.001
72614236|NCT03409367|144758528|EQUIVALENCE|The ordinal odds ratio (OR) is equal to 1. An OR \< 1 could be considered evidence that daily emollient use is associated with lower severity of AD symptoms among those diagnosed with AD.|Odds Ratio (OR)|1.45||||0.07|TWO_SIDED|95.0|0.97|2.18|||Regression, proportional odds|Adjusted for family history of atopy (stratified randomization).|Daily moisturizer is the numerator and natural skin is the denominator.|The null hypothesis is that the odds of belonging to the next higher category of severity are equal in the Daily Emollient and Natural Skin arms, or that the ordinal odds ratio (OR) is equal to 1.||2.18|0.97|0.070
72614237|NCT03409367|144758529|EQUIVALENCE|Odds ratio (OR) is equal to 1. An OR \< 1 could be considered evidence that daily emollient use is associated with lower severity of AD symptoms among those diagnosed with AD.|Odds Ratio (OR)|1.36||||0.085|TWO_SIDED|95.0|0.96|1.91|||Regression, proportional odds|Adjusted for family history of atopy (stratified randomization).||The null hypothesis is that the odds of belonging to the next higher category of severity are equal in the Daily Emollient and Natural Skin arms, or that the odds ratio (OR) is equal to 1. An OR \< 1 could be considered evidence that daily emollient use is associated with lower severity of AD symptoms among those diagnosed with AD.||1.91|0.96|0.085
72419783|NCT00406133|144350664|SUPERIORITY_OR_OTHER|||||||0.002|||||||Regression, Logistic|||Other preplanned secondary outcomes included change in A1c from baseline to 26 weeks in an ANCOVA model (adjusted for baseline A1c and clinical center) and 26-week binary A1c outcomes (decrease and increase in A1C from baseline by \>=0.3% and 26-week value \<7.0%) evaluated similarly using logistic regression models.||||0.002
72614238|NCT03409367|144758530|EQUIVALENCE|The risk ratio (RR) is equal to 1.|Risk Ratio (RR)|0.75||||0.079|TWO_SIDED|95.0|0.55|1.03|||Regression, log-binomial|Adjusted for family history of atopy (stratified randomization) and primary care site.||The null hypothesis is that the cumulative incidence of immediate food allergy reactions does not differ between the Daily Emollient and Natural Skin arms, or that the risk ratio (RR) is equal to 1.||1.03|0.55|0.079
72419784|NCT00406133|144350665|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Regression, Logistic|||Other preplanned secondary outcomes included change in A1c from baseline to 26 weeks in an ANCOVA model (adjusted for baseline A1c and clinical center) and 26-week binary A1c outcomes (decrease and increase in A1C from baseline by \>=0.3% and 26-week value \<7.0%) evaluated similarly using logistic regression models.||||<0.001
72419785|NCT03088267|144350721|SUPERIORITY||Mean Difference (Final Values)|-8.6||||0.0118|TWO_SIDED|95.0|-14.94|-2.17|||ANCOVA|||||-2.17|-14.94|0.0118
72614239|NCT03409367|144758531|EQUIVALENCE|Risk ratio (RR) is equal to 1.|Risk Ratio (RR)|0.87||||0.669|TWO_SIDED|95.0|0.45|1.66|||Regression, log-binomial|||The null hypothesis is that the cumulative incidence of food allergies does not differ between the Daily Emollient and Natural Skin arms, or that the risk ratio (RR) is equal to 1.||1.66|0.45|0.669
72614240|NCT03409367|144758532|EQUIVALENCE|Risk ratio (RR) is equal to 1. Alternatively, a RR \< 1 could be considered evidence that daily emollient is associated with lower incidence of AD.|Risk Ratio (RR)|0.77||||0.013|TWO_SIDED|95.0|0.62|0.95|||Regression, log-binomial|Adjusted for family history of atopy (stratified randomization) and primary care site.||The null hypothesis is that the cumulative incidence of AD does not differ between the Daily Emollient and Natural Skin arms, or that the risk ratio (RR) is equal to 1. Alternatively, a RR \< 1 could be considered evidence that daily emollient is associated with lower incidence of AD.||0.95|0.62|0.013
72614241|NCT03409367|144758533|EQUIVALENCE|Risk ratio (RR) is equal to 1. Alternatively, a RR \< 1 could be considered evidence that daily emollient is associated with lower incidence of AD.|Risk Ratio (RR)|0.8||||0.009|TWO_SIDED|95.0|0.67|0.94|||Regression, log-binomial|Adjusted for family history of atopy (stratified randomization) and primary care site.||The null hypothesis is that the cumulative incidence of AD does not differ between the Daily Emollient and Natural Skin arms, or that the risk ratio (RR) is equal to 1. Alternatively, a RR \< 1 could be considered evidence that daily emollient is associated with lower incidence of AD.||0.94|0.67|0.009
72614242|NCT03409367|144758534|EQUIVALENCE|Risk ratio (RR) is equal to 1.|Risk Ratio (RR)|0.77||||0.012|TWO_SIDED|95.0|0.63|0.94|||Regression, log-binomial|Adjusted for primary care site. Adjusted for multiple imputations of 121 missing outcomes.||The null hypothesis is that the cumulative incidence of AD does not differ between the Daily Emollient and Natural Skin arms, or that the risk ratio (RR) is equal to 1.||0.94|0.63|0.012
72614243|NCT03409367|144758535|EQUIVALENCE|Risk ratio (RR) is equal to 1.|Risk Ratio (RR)|0.9||||0.303|TWO_SIDED|95.0|0.73|1.1|||Regression, log-binomial|Adjusted for primary care site. Adjusted for multiple imputations of 78 missing outcomes.||The null hypothesis is that the cumulative incidence of AD does not differ between the Daily Emollient and Natural Skin arms, or that the risk ratio (RR) is equal to 1.||1.10|0.73|0.303
72614244|NCT03824158|144758552|SUPERIORITY|||||||0.0014|||||||Mixed Models Analysis|||||||0.0014
72614245|NCT03824158|144758553|SUPERIORITY|||||||0.76|||||||Regression, Logistic|||||||0.76
72614246|NCT03824158|144758554|SUPERIORITY|||||||0.13|||||||Mixed Models Analysis|||||||0.13
72614247|NCT03824158|144758555|SUPERIORITY|||||||0.008|||||||Mixed Models Analysis|||||||0.008
72614248|NCT03824158|144758556|SUPERIORITY|||||||0.002|||||||Chi-squared|||Advance directive or living will||||0.002
72614249|NCT03824158|144758556|SUPERIORITY|||||||0.02|||||||Fisher Exact|||POLST||||0.02
72614250|NCT03824158|144758556|SUPERIORITY|||||||0.78|||||||Chi-squared|||Code Status||||0.78
72614251|NCT03824158|144758556|SUPERIORITY|||||||0.61|||||||Chi-squared|||Goals of Care discussion||||0.61
72614252|NCT03824158|144758557|SUPERIORITY|||||||0.17|||||||Mixed Models Analysis|||||||0.17
72419786|NCT03088267|144350722|SUPERIORITY||Mean Difference (Final Values)|18.8||||0.1128|TWO_SIDED|95.0|-4.94|42.5|||ANCOVA|||Comparison at 30 minutes post-dose||42.50|-4.94|0.1128
72614253|NCT03824158|144758558|SUPERIORITY|||||||0.11|||||||Mixed Models Analysis|||||||0.11
72614254|NCT03488524|144758579|SUPERIORITY||Mean Difference (Final Values)|4.23|STANDARD_ERROR_OF_MEAN|1.87||0.0239|TWO_SIDED|95.0|0.56|7.9||Significance testing was 2-tailed and considered statistically significant if the calculated p-value was ≤0.05.|Mixed Models Analysis|Random-slope, shared-baseline, linear mixed model was adjusted for age and prebaseline ALSFRS-R slope.||Participants who did not enter the open-label extension (OLE) were included in this analysis.||7.90|0.56|0.0239
72614255|NCT03488524|144758580|SUPERIORITY||Hazard Ratio (HR)|0.644||||0.0475|TWO_SIDED|95.0|0.416|0.995|||Hazard ratio|||Cox Proportional Hazards analysis||0.995|0.416|0.0475
72614256|NCT03488524|144758581|SUPERIORITY||Hazard Ratio (HR)|0.621||||0.0308|TWO_SIDED|95.0|0.403|0.957|||Hazard Ratio|||||0.957|0.403|0.0308
72614257|NCT03488524|144758582|SUPERIORITY||Mean Difference (Final Values)|7.77|STANDARD_ERROR_OF_MEAN|3.55||0.0291|TWO_SIDED|95.0|0.8|14.75|||Mixed Models Analysis|||||14.75|0.80|0.0291
72614258|NCT03488524|144758583|SUPERIORITY||Mean Difference (Final Values)|4.76|STANDARD_ERROR_OF_MEAN|3.923||0.2261|TWO_SIDED|95.0|-2.95|12.47|||Mixed Models Analysis|||||12.47|-2.95|0.2261
72614259|NCT03488524|144758584|SUPERIORITY||Mean Difference (Final Values)|10.66|STANDARD_ERROR_OF_MEAN|5.103||0.0372|TWO_SIDED|95.0|0.63|20.69||Nominal p-value|Mixed Models Analysis|||||20.69|0.63|0.0372
72614260|NCT03488524|144758585|SUPERIORITY|||||||0.0503||||||Nominal p-value|Mixed Models Analysis|||||||0.0503
72614261|NCT01913353|144758594|NON_INFERIORITY|The non-inferiority margin to show that Group 1 (after 2 doses of MVA-BN) is non-inferior to Group 2 (after 1 dose of ACAM2000) in terms of PRNT GMTs at the respective peak visit (Week 6 in Group 1 / Week 4 in Group 2) was predefined as '1/2 (i.e. 0.5)' for the GMT ratio (Group 1 / Group 2).|GMT Ratio (Group 1 / Group 2)|1.935|||||TWO_SIDED|95.0|1.562|2.397||||||||2.397|1.562|
72614262|NCT01913353|144758595|SUPERIORITY|Predefined threshold of clinical relevance for the area attenuation ratio (AAR): 40%|Area attenuation ratio (AAR)|97.9|||||TWO_SIDED|95.0|96.6|98.3|||||The AAR, i.e. the reduction in MLA \[1 - MLA ratio (Group 1/Group 2)\] after scarification was to be significantly above 40%. The MLA ratio and the corresponding 95% CI were based on the Hodges-Lehmann estimate of the shift for log-transformed MLAs.|||98.3|96.6|
72614263|NCT01260948|144758618|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|98.72|||||TWO_SIDED|90.0|94.13|103.53|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||103.53|94.13|
72614264|NCT01260948|144758619|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|94.81|||||TWO_SIDED|90.0|91.3|98.47|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||98.47|91.30|
72614265|NCT03459846|144758632|SUPERIORITY||Hazard Ratio (HR)|0.94||||0.789|TWO_SIDED|95.0|0.641|1.387|||Regression, Cox|||||1.387|0.641|0.789
72614266|NCT03459846|144758633|SUPERIORITY||Hazard Ratio (HR)|1.07||||0.728|TWO_SIDED|95.0|0.719|1.606|||Regression, Cox|||||1.606|0.719|0.728
72614267|NCT03459846|144758634|SUPERIORITY||Odds Ratio (OR)|1.76||||0.142|TWO_SIDED|95.0|0.821|3.778|||Regression, Logistic|||||3.778|0.821|0.142
72614268|NCT02141113|144758644|SUPERIORITY_OR_OTHER_LEGACY|||||||0.779|||||||ANOVA|||These scores were calculated by subtracting participants' endpoint scores from their initial baseline scores. These changed scores show the total change in ADHD symptoms over the course of the trial. Higher values indiicate improved functioning at the end of the trial compared to the beginning.||||.779
72614269|NCT02141113|144758645|SUPERIORITY|||||||0.834|||||||ANOVA|||||||.834
72614270|NCT02141113|144758646|SUPERIORITY_OR_OTHER_LEGACY|||||||0.705|TWO_SIDED||||||ANOVA|||||||.705
72614271|NCT02141113|144758647|SUPERIORITY_OR_OTHER_LEGACY|||||||0.322|TWO_SIDED||||||ANOVA|||||||.322
72614272|NCT02141113|144758648|SUPERIORITY_OR_OTHER_LEGACY|||||||0.043|TWO_SIDED||||||ANOVA|||||||.043
72614273|NCT02141113|144758649|SUPERIORITY_OR_OTHER_LEGACY|||||||0.212|TWO_SIDED||||||ANOVA|||||||.212
72614274|NCT04253626|144758652|OTHER||||||<|0.001||||||The a priori threshold for statistical significance was 0.05.|Wilcoxon (Mann-Whitney)|||||||< 0.001
72614275|NCT04253626|144758656|OTHER|||||||0.88||||||The a priori threshold for statistical significance was \< 0.05.|Wilcoxon (Mann-Whitney)|||Between-group analysis of change at week 4||||0.88
72614276|NCT04253626|144758657|OTHER|||||||0.27|||||||Wilcoxon (Mann-Whitney)|The a priori threshold for statistical significance was \< 0.05.||Between-group analysis of change at week 4||||0.27
72614277|NCT04253626|144758658|OTHER|||||||0.72||||||The a priori threshold for statistical significance was \< 0.05.|Wilcoxon (Mann-Whitney)|||Between-group analysis of change at week 4||||0.72
72614278|NCT04253626|144758659|OTHER|||||||0.009||||||The a priori threshold for statistical significance was \< 0.05.|Wilcoxon (Mann-Whitney)|||Between-group analysis of change at week 4||||0.009
72614279|NCT05763875|144758662|SUPERIORITY||LS Mean Difference|-35.37|||<|0.0001|TWO_SIDED|95.0|-40.88|-29.86|||ANCOVA|||Treatment Policy Estimand||-29.86|-40.88|<0.0001
72614280|NCT05763875|144758662|SUPERIORITY||LS Mean Difference|-47.91|||<|0.0001|TWO_SIDED|95.0|-53.62|-42.2|||ANCOVA|||Treatment Policy Estimand||-42.20|-53.62|<0.0001
72614281|NCT05763875|144758662|SUPERIORITY||LS Mean Difference|-37.44|||<|0.0001|TWO_SIDED|95.0|-42.63|-32.26|||ANCOVA|||Monotherapy Estimand||-32.26|-42.63|<0.0001
72614282|NCT05763875|144758662|SUPERIORITY||LS Mean Difference|-50.9|||<|0.0001|TWO_SIDED|95.0|-56.51|-45.28|||ANCOVA|||Monotherapy Estimand||-45.28|-56.51|<0.0001
72614283|NCT05763875|144758663|SUPERIORITY||LS Mean Difference|-47.37|||<|0.0001|TWO_SIDED|95.0|-53.91|-40.72|||ANCOVA|||Treatment Policy Estimand||-40.72|-53.91|<0.0001
72614284|NCT05763875|144758663|SUPERIORITY||LS Mean Difference|-63.57|||<|0.0001|TWO_SIDED|95.0|-70.28|-56.87|||ANCOVA|||Treatment Policy Estimand||-56.87|-70.28|<0.0001
72614285|NCT05763875|144758663|SUPERIORITY||LS Mean Difference|-50.05|||<|0.0001|TWO_SIDED|95.0|-56.16|-43.94|||ANCOVA|||Monotherapy Estimand||-43.94|-56.16|<0.0001
72614286|NCT05763875|144758663|SUPERIORITY||LS Mean Difference|-67.51|||<|0.0001|TWO_SIDED|95.0|-74.09|-60.92|||ANCOVA|||Monotherapy Estimand||-60.92|-74.09|<0.0001
72614287|NCT05763875|144758664|SUPERIORITY||LS Mean Difference|-73.16|||<|0.0001|TWO_SIDED|95.0|-81.76|-64.56|||ANCOVA|||Treatment Policy Estimand||-64.56|-81.76|<0.0001
72614288|NCT05763875|144758664|SUPERIORITY||LS Mean Difference|-74.94|||<|0.0001|TWO_SIDED|95.0|-84.51|-65.37|||ANCOVA|||Treatment Policy Estimand||-65.37|-84.51|<0.0001
72614289|NCT05763875|144758664|SUPERIORITY||LS Mean Difference|-76.87|||<|0.0001|TWO_SIDED|95.0|-85.12|-68.62|||ANCOVA|||Monotherapy Estimand||-68.62|-85.12|<0.0001
72614290|NCT05763875|144758664|SUPERIORITY||LS Mean Difference|-79.47|||<|0.0001|TWO_SIDED|95.0|-88.77|-70.17|||ANCOVA|||Monotherapy Estimand||-70.17|-88.77|<0.0001
72614291|NCT05763875|144758665|SUPERIORITY||LS Mean Difference|-30.48|||<|0.0001|TWO_SIDED|95.0|-34.98|-25.98|||ANCOVA|||Treatment Policy Estimand||-25.98|-34.98|<0.0001
72614292|NCT05763875|144758665|SUPERIORITY||LS Mean Difference|-42.32|||<|0.0001|TWO_SIDED|95.0|-47.83|-36.82|||ANCOVA|||Treatment Policy Estimand||-36.82|-47.83|<0.0001
72614293|NCT05763875|144758665|SUPERIORITY||LS Mean Difference|-31.98|||<|0.0001|TWO_SIDED|95.0|-36.07|-27.89|||ANCOVA|||Monotherapy Estimand||-27.89|-36.07|<0.0001
72614294|NCT05763875|144758665|SUPERIORITY||LS Mean Difference|-44.86|||<|0.0001|TWO_SIDED|95.0|-50.28|-39.44|||ANCOVA|||Monotherapy Estimand||-39.44|-50.28|<0.0001
72614295|NCT05763875|144758666|SUPERIORITY||LS Mean Difference|-24.84|||<|0.0001|TWO_SIDED|95.0|-30.32|-19.36|||ANCOVA|||Treatment Policy Estimand||-19.36|-30.32|<0.0001
72614296|NCT05763875|144758666|SUPERIORITY||LS Mean Difference|-33.85|||<|0.0001|TWO_SIDED|95.0|-41.27|-26.44|||ANCOVA|||Treatment Policy Estimand||-26.44|-41.27|<0.0001
72614297|NCT05763875|144758666|SUPERIORITY||LS Mean Difference|-26.58|||<|0.0001|TWO_SIDED|95.0|-32.07|-21.09|||ANCOVA|||Monotherapy Estimand||-21.09|-32.07|<0.0001
72614298|NCT05763875|144758666|SUPERIORITY||LS Mean Difference|-36.06|||<|0.0001|TWO_SIDED|95.0|-43.46|-28.67|||ANCOVA|||Monotherapy Estimand||-28.67|-43.46|<0.0001
72614299|NCT05763875|144758667|SUPERIORITY||LS Mean Difference|-28.98|||<|0.0001|TWO_SIDED|95.0|-33.3|-24.65|||ANCOVA|||Treatment Policy Estimand||-24.65|-33.30|<0.0001
72614300|NCT05763875|144758667|SUPERIORITY||LS Mean Difference|-36.66|||<|0.0001|TWO_SIDED|95.0|-41.1|-32.22|||ANCOVA|||Treatment Policy Estimand||-32.22|-41.10|<0.0001
72614301|NCT05763875|144758667|SUPERIORITY||LS Mean Difference|-30.16|||<|0.0001|TWO_SIDED|95.0|-34.08|-26.23|||ANCOVA|||Monotherapy Estimand||-26.23|-34.08|<0.0001
72614302|NCT05763875|144758667|SUPERIORITY||LS Mean Difference|-38.78|||<|0.0001|TWO_SIDED|95.0|-43.12|-34.43|||ANCOVA|||Monotherapy Estimand||-34.43|-43.12|<0.0001
72614303|NCT05763875|144758668|SUPERIORITY||LS Mean Difference|-30.24|||<|0.0001|TWO_SIDED|95.0|-36.92|-23.57|||ANCOVA|||Treatment Policy Estimand||-23.57|-36.92|<0.0001
72614304|NCT05763875|144758668|SUPERIORITY||LS Mean Difference|-35.15|||<|0.0001|TWO_SIDED|95.0|-41.18|-29.12|||ANCOVA|||Treatment Policy Estimand||-29.12|-41.18|<0.0001
72614305|NCT05763875|144758668|SUPERIORITY||LS Mean Difference|-32.34|||<|0.0001|TWO_SIDED|95.0|-39.1|-25.59|||ANCOVA|||Monotherapy Estimand||-25.59|-39.10|<0.0001
72614306|NCT05763875|144758668|SUPERIORITY||LS Mean Difference|-37.38|||<|0.0001|TWO_SIDED|95.0|-43.44|-31.31|||ANCOVA|||Monotherapy Estimand||-31.31|-43.44|<0.0001
72614307|NCT05763875|144758669|SUPERIORITY||Ratio of Geometric Mean|0.757||||0.0002|TWO_SIDED|95.0|0.65|0.882|||ANCOVA|||Treatment Policy Estimand||0.882|0.650|0.0002
72614308|NCT05763875|144758669|SUPERIORITY||Ratio of Geometric Mean|0.748||||0.001|TWO_SIDED|95.0|0.622|0.898|||ANCOVA|||Treatment Policy Estimand||0.898|0.622|0.0010
72614309|NCT05763875|144758669|SUPERIORITY||Ratio of Geometric Mean|0.753|||<|0.0001|TWO_SIDED|95.0|0.652|0.871|||ANCOVA|||Monotherapy Estimand||0.871|0.652|<0.0001
72614310|NCT05763875|144758669|SUPERIORITY||Ratio of Geometric Mean|0.746||||0.0008|TWO_SIDED|95.0|0.622|0.893|||ANCOVA|||Monotherapy Estimand||0.893|0.622|0.0008
72614311|NCT00217737|144758671|SUPERIORITY||Hazard Ratio (HR)|0.83|||||TWO_SIDED|95.0|0.63|1.11|||||Hazard ratio: Arm B/Arm A|||1.11|0.63|
72614312|NCT03279458|144758786|OTHER|least square regression analysis|correlation coefficient (R)|0.94|||<|0.05|TWO_SIDED|95.0|0.88|0.97|||Regression, Linear|||||0.97|0.88|<0.05
72614313|NCT01147458|144758795|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.56|STANDARD_ERROR_OF_MEAN|0.374||0.067|TWO_SIDED|80.0|0.08|1.04|||ANCOVA|||The analysis was a mixed model with random participant effect, period and treatment as fixed effects, utilizing the baseline scores (one for each treatment period) as inter- and intra- participant covariates.||1.04|0.08|0.067
72614314|NCT01147458|144758795|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.2|STANDARD_ERROR_OF_MEAN|0.369||0.701|TWO_SIDED|80.0|-0.67|0.28|||ANCOVA|||The analysis was a mixed model with random participant effect, period and treatment as fixed effects, utilizing the baseline scores (one for each treatment period) as inter- and intra- participant covariates.||0.28|-0.67|0.701
72614315|NCT01147458|144758796|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.56|STANDARD_ERROR_OF_MEAN|0.374||0.067|TWO_SIDED|80.0|0.08|1.04|||ANCOVA|||The analysis was a mixed model with random participant effect, period and treatment as fixed effects, utilizing the baseline scores (one for each treatment period) as inter- and intra- participant covariates.||1.04|0.08|0.067
72614316|NCT01147458|144758796|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.2|STANDARD_ERROR_OF_MEAN|0.369||0.701|TWO_SIDED|80.0|-0.67|0.28|||ANCOVA|||The analysis was a mixed model with random participant effect, period and treatment as fixed effects, utilizing the baseline scores (one for each treatment period) as inter- and intra- participant covariates.||0.28|-0.67|0.701
72614317|NCT01147458|144758797|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.07|STANDARD_ERROR_OF_MEAN|0.172|||TWO_SIDED|80.0|-0.15|0.29|||ANCOVA|||The analysis was a mixed model with random participant effect, period and treatment as fixed effects, utilizing the baseline scores (one for each treatment period) as inter- and intra- participant covariates.||0.29|-0.15|
72614318|NCT01147458|144758797|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.13|STANDARD_ERROR_OF_MEAN|0.17|||TWO_SIDED|80.0|-0.09|0.35|||ANCOVA|||The analysis was a mixed model with random participant effect, period and treatment as fixed effects, utilizing the baseline scores (one for each treatment period) as inter- and intra- participant covariates.||0.35|-0.09|
72614319|NCT01147458|144758798|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.26|STANDARD_ERROR_OF_MEAN|1.239|||TWO_SIDED|80.0|-0.34|2.85|||ANCOVA|||The analysis was a mixed model with random participant effect, period and treatment as fixed effects, utilizing the baseline scores (one for each treatment period) as inter- and intra- participant covariates.||2.85|-0.34|
72614320|NCT01147458|144758798|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.34|STANDARD_ERROR_OF_MEAN|1.252|||TWO_SIDED|80.0|-1.95|1.28|||ANCOVA|||The analysis was a mixed model with random participant effect, period and treatment as fixed effects, utilizing the baseline scores (one for each treatment period) as inter- and intra- participant covariates.||1.28|-1.95|
72614321|NCT01147458|144758799|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.06|STANDARD_ERROR_OF_MEAN|1.699|||TWO_SIDED|80.0|-0.13|4.25|||ANCOVA|||The analysis was a mixed model with random participant effect, period and treatment as fixed effects, utilizing the baseline scores (one for each treatment period) as inter- and intra- participant covariates.||4.25|-0.13|
72614322|NCT01147458|144758799|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.33|STANDARD_ERROR_OF_MEAN|1.709|||TWO_SIDED|80.0|-2.53|1.88|||ANCOVA|||The analysis was a mixed model with random participant effect, period and treatment as fixed effects, utilizing the baseline scores (one for each treatment period) as inter- and intra- participant covariates.||1.88|-2.53|
72327463|NCT02628444|144178603|SUPERIORITY|The superiority was demonstrated if the lower limit of the two-sided 95% CI was greater than 1 between groups (Group 2/Group 1). Overall superiority of Group 2 to Group 1 was demonstrated if individual serotype null hypotheses were rejected.|GMT Ratio|0.99|||||TWO_SIDED|95.0|0.821|1.19||||||Group2/Group1: Serotype 2 (28 days after last vaccination)||1.19|0.821|
72327464|NCT02628444|144178603|SUPERIORITY|The superiority was demonstrated if the lower limit of the two-sided 95% CI was greater than 1 between groups (Group 2/Group 1). Overall superiority of Group 2 to Group 1 was demonstrated if individual serotype null hypotheses were rejected.|GMT Ratio|0.972|||||TWO_SIDED|95.0|0.81|1.17||||||Group2/Group1: Serotype 3 (28 days after last vaccination)||1.17|0.810|
72419787|NCT03088267|144350722|SUPERIORITY||Mean Difference (Final Values)|60.3||||0.0003|TWO_SIDED|95.0|32.91|87.75|||ANCOVA|||Comparison at 3 hours postdose||87.75|32.91|0.0003
72419788|NCT01895972|144350723|OTHER||||||<|0.001||||||The reduction from baseline in IOP was significant at all post-baseline assessment time points through Week 52.|t-test, 2 sided|||comparison vs. baseline||||<0.001
72419789|NCT01800968|144350744|SUPERIORITY_OR_OTHER|||||||0.3087|||||||Rank score|||||||0.3087
72419790|NCT01800968|144350745|SUPERIORITY_OR_OTHER|||||||0.1549|||||||Regression, Linear|||||||0.1549
72419791|NCT01800968|144350746|SUPERIORITY_OR_OTHER|||||||0.1932|||||||Regression, Linear|||||||0.1932
72327465|NCT02628444|144178603|SUPERIORITY|The superiority was demonstrated if the lower limit of the two-sided 95% CI was greater than 1 between groups (Group 2/Group 1). Overall superiority of Group 2 to Group 1 was demonstrated if individual serotype null hypotheses were rejected.|GMT Ratio|0.963|||||TWO_SIDED|95.0|0.814|1.14||||||Group2/Group1: Serotype 4 (28 days after last vaccination)||1.14|0.814|
72419792|NCT01800968|144350747|SUPERIORITY_OR_OTHER|||||||0.9535|||||||Regression, Linear|||||||0.9535
72419793|NCT01800968|144350748|SUPERIORITY_OR_OTHER|||||||0.8548|||||||Regression, Linear|||||||0.8548
72419794|NCT01800968|144350749|SUPERIORITY_OR_OTHER|||||||0.4266|||||||Regression, Linear|||||||0.4266
72419795|NCT01800968|144350750|SUPERIORITY_OR_OTHER|||||||0.1705|||||||Regression, Linear|||||||0.1705
72419796|NCT01800968|144350751|SUPERIORITY_OR_OTHER|||||||0.1309|||||||Regression, Linear|||||||0.1309
72419797|NCT01800968|144350752|SUPERIORITY_OR_OTHER|||||||0.792|||||||Regression, Linear|||||||0.7920
72614323|NCT01147458|144758800|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.77|STANDARD_ERROR_OF_MEAN|0.624|||TWO_SIDED|80.0|-0.03|1.58|||ANCOVA|||The analysis was a mixed model with random participant effect, period and treatment as fixed effects, utilizing the baseline scores (one for each treatment period) as inter- and intra- participant covariates.||1.58|-0.03|
72614324|NCT01147458|144758800|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.16|STANDARD_ERROR_OF_MEAN|0.628|||TWO_SIDED|80.0|-0.97|0.65|||ANCOVA|||The analysis was a mixed model with random participant effect, period and treatment as fixed effects, utilizing the baseline scores (one for each treatment period) as inter- and intra- participant covariates.||0.65|-0.97|
72614325|NCT01147458|144758801|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.01|STANDARD_ERROR_OF_MEAN|0.15|||TWO_SIDED|80.0|-0.18|0.2|||ANCOVA|||The analysis was a mixed model with random participant effect, period and treatment as fixed effects, utilizing the baseline scores (one for each treatment period) as inter- and intra- participant covariates.||0.20|-0.18|
72614326|NCT01147458|144758801|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.12|STANDARD_ERROR_OF_MEAN|0.147|||TWO_SIDED|80.0|-0.07|0.31|||ANCOVA|||The analysis was a mixed model with random participant effect, period and treatment as fixed effects, utilizing the baseline scores (one for each treatment period) as inter- and intra- participant covariates.||0.31|-0.07|
72419798|NCT01800968|144350753|SUPERIORITY_OR_OTHER|||||||0.7026|||||||Regression, Linear|||||||0.7026
72419799|NCT01800968|144350754|SUPERIORITY_OR_OTHER|||||||0.2662|||||||Regression, Linear|||||||0.2662
72419800|NCT01800968|144350755|SUPERIORITY_OR_OTHER|||||||0.6395|||||||Regression, Linear|||||||0.6395
72419801|NCT01800968|144350756|SUPERIORITY_OR_OTHER|||||||0.8218|||||||Regression, Linear|||||||0.8218
72419802|NCT01800968|144350757|SUPERIORITY_OR_OTHER|||||||0.1124|||||||Regression, Linear|||||||0.1124
72419803|NCT01800968|144350758|SUPERIORITY_OR_OTHER|||||||0.8088|||||||Regression, Linear|||||||0.8088
72419804|NCT01800968|144350759|SUPERIORITY_OR_OTHER|||||||0.7764|||||||Log Rank|||||||0.7764
72419805|NCT01800968|144350760|SUPERIORITY_OR_OTHER|||||||0.1701|||||||Log Rank|||||||0.1701
72419806|NCT01800968|144350761|SUPERIORITY_OR_OTHER|||||||0.6532|||||||Regression, Linear|||||||0.6532
72419807|NCT01800968|144350762|SUPERIORITY_OR_OTHER|||||||0.2033|||||||Rank score|||||||0.2033
72419808|NCT01422408|144350786|OTHER|Two-sided test that the change is different from zero. Not tested against alternative treatment; single arm study.|||||<|0.001||||||2.5% significance level to account for two co-primary endpoints.|Wilcoxon (Mann-Whitney)|||The primary endpoints (i.e., change in symptoms of vaginal dryness from the baseline to 4 weeks, and change in symptoms of dyspareunia from the baseline to 4 weeks) will be analyzed using Wilcoxon signed rank test with 2.5% significance level to account for two co-primary endpoints.||||<0.001
72419809|NCT01422408|144350786|OTHER|Exact McNemar's test was used to test if the proportion of severe symptoms at baseline are equal to the proportion of severe symptoms at the end of the study.|Odds Ratio (OR)|0.0||||0.001|TWO_SIDED|95.0|0.0|0.36||Since there are two-co-primary endpoints, the significance level is 2.5%|McNemar|||"GEE (general estimating equation) methods were planned as a secondary analysis of the primary endpoints. Missing data for some of the weeks prevented these models from converging and we could not obtain valid results with these methods. Since this is a secondary analysis, we decided to compare symptom severity at baseline vs. week 4 (end of study). Symptoms are considered severe for scores 3 or 4 and not severe for scores 0, 1, 2"||0.36|0|0.001
72614327|NCT01147458|144758802|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.09|STANDARD_ERROR_OF_MEAN|0.168|||TWO_SIDED|80.0|-0.12|0.31|||ANCOVA|||The analysis was a mixed model with random participant effect, period and treatment as fixed effects, utilizing the baseline scores (one for each treatment period) as inter- and intra- participant covariates.||0.31|-0.12|
72614328|NCT01147458|144758802|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.1|STANDARD_ERROR_OF_MEAN|0.162|||TWO_SIDED|80.0|-0.11|0.31|||ANCOVA|||The analysis was a mixed model with random participant effect, period and treatment as fixed effects, utilizing the baseline scores (one for each treatment period) as inter- and intra- participant covariates.||0.31|-0.11|
72614329|NCT02555878|144758809|SUPERIORITY||Hazard Ratio (HR)|0.66|||=|0.101|TWO_SIDED|95.0|0.4|1.09|||Log Rank|||Statistical analysis for primary efficacy composite endpoint.||1.09|0.40|= 0.101
72419810|NCT01422408|144350787|OTHER|Two-sided test that the change is different from zero. Not tested against alternative treatment; single arm study.||||||0.002||||||2.5% significance level to account for two co-primary endpoints.|Wilcoxon (Mann-Whitney)|||The primary endpoints (i.e., change in symptoms of vaginal dryness from the baseline to 4 weeks, and change in symptoms of dyspareunia from the baseline to 4 weeks) will be analyzed using Wilcoxon signed rank test with 2.5% significance level to account for two co-primary endpoints.||||0.002
72419811|NCT01422408|144350787|OTHER|Exact McNemar's test was used to test if the proportion of severe symptoms at baseline are equal to the proportion of severe symptoms at the end of the study.|Odds Ratio (OR)|0.0||||0.062|TWO_SIDED|95.0|0.0|1.09||Since there are two-co-primary endpoints, the significance level is 2.5%|McNemar|||"GEE (general estimating equations) methods were planned as a secondary analysis of the primary endpoints. Missing data for some of the weeks prevented these models from converging and we could not obtain valid results with these methods. Since this is a secondary analysis, we decided to compare symptom severity at baseline vs. week 4 (end of study). Symptoms are considered severe for scores 3 or 4 and not severe for scores 0, 1, 2"||1.09|0|0.062
72419812|NCT01422408|144350788|OTHER|Two-sided test that the change is different from zero. Not tested against alternative treatment; single arm study.||||||0.001|||||||Wilcoxon (Mann-Whitney)|||The secondary endpoints (i.e., change in symptoms of vaginal itching from the baseline to 4 weeks, and change in vaginal index score from the baseline to 4 weeks) will be analyzed using Wilcoxon signed rank test with 2.5% significance level to account for two co-secondary endpoints.||||0.001
72419813|NCT01422408|144350789|OTHER|2.5% significance level to account for two co-primary endpoints.||||||0.002|||||||Wilcoxon (Mann-Whitney)|||The secondary endpoints (i.e., change in symptoms of vaginal itching from the baseline to 4 weeks, and change in vaginal index score from the baseline to 4 weeks) will be analyzed using Wilcoxon signed rank test with 2.5% significance level to account for two co-secondary endpoints.||||0.002
72419814|NCT01422408|144350791|OTHER|||||||0.1029||||||No adjustment for multiple comparison. Significance level of 0.05. Since this endpoint is of an exploratory nature and the significance is well above the threshold, not much more consideration was given to the issue of multiple comparisons|ANOVA|Kruskal-Wallis ANOVA rather than ANOVA since normal distribution of residuals may be suspect.||In order to compare the response between groups, Kruskal-Wallis ANOVA was used.||||0.1029
72419815|NCT01422408|144350792|OTHER|||||||0.2678||||||No adjustment for multiple comparison. Significance level of 0.05. Since this endpoint is of an exploratory nature and the significance is well above the threshold, not much more consideration was given to the issue of multiple comparisons|ANOVA|Kruskal-Wallis ANOVA rather than ANOVA since normal distribution of residuals may be suspect.||In order to compare the response between groups, Kruskal-Wallis ANOVA was used.||||0.2678
72419816|NCT01422408|144350793|OTHER|||||||0.2472||||||No adjustment for multiple comparison. Significance level of 0.05. Since this endpoint is of an exploratory nature and the significance is well above the threshold, not much more consideration was given to the issue of multiple comparisons|ANOVA|Kruskal-Wallis ANOVA rather than ANOVA since normal distribution of residuals may be suspect.||In order to compare the response between groups, Kruskal-Wallis ANOVA was used.||||0.2472
72419817|NCT01422408|144350794|OTHER|||||||0.507||||||No adjustment for multiple comparison. Significance level of 0.05. Since this endpoint is of an exploratory nature and the significance is well above the threshold, not much more consideration was given to the issue of multiple comparisons|ANOVA|Kruskal-Wallis ANOVA rather than ANOVA since normal distribution of residuals may be suspect.||In order to compare the response between groups, Kruskal-Wallis ANOVA was used.||||0.507
72419818|NCT01422408|144350795|OTHER|||||||0.3676||||||No adjustment for multiple comparison. Significance level of 0.05. Since this endpoint is of an exploratory nature and the significance is well above the threshold, not much more consideration was given to the issue of multiple comparisons|ANOVA|Kruskal-Wallis ANOVA rather than ANOVA since normal distribution of residuals may be suspect.||In order to compare the response between groups, Kruskal-Wallis ANOVA was used.||||0.3676
72419819|NCT01422408|144350796|OTHER|||||||0.6023||||||No adjustment for multiple comparison. Significance level of 0.05. Since this endpoint is of an exploratory nature and the significance is well above the threshold, not much more consideration was given to the issue of multiple comparisons|ANOVA|Kruskal-Wallis ANOVA rather than ANOVA since normal distribution of residuals may be suspect.||In order to compare the response between groups, Kruskal-Wallis ANOVA was used.||||0.6023
72419820|NCT01422408|144350797|OTHER|||||||0.6587||||||No adjustment for multiple comparison. Significance level of 0.05. Since this endpoint is of an exploratory nature and the significance is well above the threshold, not much more consideration was given to the issue of multiple comparisons|ANOVA|Kruskal-Wallis ANOVA rather than ANOVA since normal distribution of residuals may be suspect.||In order to compare the response between groups, Kruskal-Wallis ANOVA was used.||||0.6587
72419821|NCT01422408|144350798|OTHER|||||||0.8772||||||No adjustment for multiple comparison. Significance level of 0.05. Since this endpoint is of an exploratory nature and the significance is well above the threshold, not much more consideration was given to the issue of multiple comparisons|ANOVA|Kruskal-Wallis ANOVA rather than ANOVA since normal distribution of residuals may be suspect.||In order to compare the response between groups, Kruskal-Wallis ANOVA was used.||||0.8772
72614330|NCT02555878|144758809|SUPERIORITY||Hazard Ratio (HR)|1.12|||=|0.814|TWO_SIDED|95.0|0.43|2.91|||Log Rank|||Statistical analysis for Symptomatic lower extremity proximal DVT.||2.91|0.43|= 0.814
72614331|NCT02555878|144758809|SUPERIORITY||Hazard Ratio (HR)|0.4|||=|0.26|TWO_SIDED|95.0|0.08|2.07|||Log Rank|||Statistical analysis for symptomatic lower extremity distal DVT.||2.07|0.08|= 0.260
72614332|NCT02555878|144758809|SUPERIORITY||Hazard Ratio (HR)|0.67|||=|0.538|TWO_SIDED|95.0|0.19|2.39|||Log Rank|||Statistical analysis for symptomatic upper extremity DVT.||2.39|0.19|= 0.538
72614333|NCT02555878|144758809|SUPERIORITY||Hazard Ratio (HR)|1.02|||=|0.977|TWO_SIDED|95.0|0.29|3.52|||Log Rank|||Statistical analysis for symptomatic non-fatal PE.||3.52|0.29|= 0.977
72614334|NCT02555878|144758809|SUPERIORITY||Hazard Ratio (HR)|0.35|||=|0.063|TWO_SIDED|95.0|0.11|1.11|||Log Rank|||Statistical analysis for asymptomatic lower extremity proximal DVT.||1.11|0.11|= 0.063
72614335|NCT02555878|144758809|SUPERIORITY||Hazard Ratio (HR)|0.59|||=|0.301|TWO_SIDED|95.0|0.21|1.62|||Log Rank|||Statistical analysis for incidental PE.||1.62|0.21|= 0.301
72614336|NCT02555878|144758809|SUPERIORITY||Hazard Ratio (HR)|0.33|||=|0.314|TWO_SIDED|95.0|0.03|3.18|||Log Rank|||Statistical analysis for VTE-related death.||3.18|0.03|= 0.314
72419822|NCT01422408|144350799|OTHER|||||||0.7395||||||No adjustment for multiple comparison. Significance level of 0.05. Since this endpoint is of an exploratory nature and the significance is well above the threshold, not much more consideration was given to the issue of multiple comparisons|ANOVA|Kruskal-Wallis ANOVA rather than ANOVA since normal distribution of residuals may be suspect.||In order to compare the response between groups, Kruskal-Wallis ANOVA was used.||||0.7395
72419823|NCT01422408|144350800|OTHER|||||||0.9618||||||No adjustment for multiple comparison. Significance level of 0.05. Since this endpoint is of an exploratory nature and the significance is well above the threshold, not much more consideration was given to the issue of multiple comparisons|ANOVA|Kruskal-Wallis ANOVA rather than ANOVA since normal distribution of residuals may be suspect.||In order to compare the response between groups, Kruskal-Wallis ANOVA was used.||||0.9618
72419824|NCT01422408|144350801|OTHER|||||||0.5113||||||No adjustment for multiple comparison. Significance level of 0.05. Since this endpoint is of an exploratory nature and the significance is well above the threshold, not much more consideration was given to the issue of multiple comparisons|ANOVA|Kruskal-Wallis ANOVA rather than ANOVA since normal distribution of residuals may be suspect.||In order to compare the response between groups, Kruskal-Wallis ANOVA was used.||||0.5113
72419825|NCT01422408|144350802|OTHER|||||||0.8833||||||No adjustment for multiple comparison. Significance level of 0.05. Since this endpoint is of an exploratory nature and the significance is well above the threshold, not much more consideration was given to the issue of multiple comparisons|ANOVA|Kruskal-Wallis ANOVA rather than ANOVA since normal distribution of residuals may be suspect.||In order to compare the response between groups, Kruskal-Wallis ANOVA was used.||||0.8833
72419826|NCT01422408|144350803|OTHER|||||||0.7983||||||No adjustment for multiple comparison. Significance level of 0.05. Since this endpoint is of an exploratory nature and the significance is well above the threshold, not much more consideration was given to the issue of multiple comparisons|ANOVA|Kruskal-Wallis ANOVA rather than ANOVA since normal distribution of residuals may be suspect.||In order to compare the response between groups, Kruskal-Wallis ANOVA was used.||||0.7983
72419827|NCT01422408|144350804|OTHER|||||||0.4937||||||No adjustment for multiple comparison. Significance level of 0.05. Since this endpoint is of an exploratory nature and the significance is well above the threshold, not much more consideration was given to the issue of multiple comparisons|ANOVA|Kruskal-Wallis ANOVA rather than ANOVA since normal distribution of residuals may be suspect.||In order to compare the response between groups, Kruskal-Wallis ANOVA was used.||||0.4937
72419828|NCT01422408|144350805|OTHER|||||||0.9106||||||No adjustment for multiple comparison. Significance level of 0.05. Since this endpoint is of an exploratory nature and the significance is well above the threshold, not much more consideration was given to the issue of multiple comparisons|ANOVA|Kruskal-Wallis ANOVA rather than ANOVA since normal distribution of residuals may be suspect.||In order to compare the response between groups, Kruskal-Wallis ANOVA was used.||||0.9106
72419829|NCT01422408|144350806|OTHER|||||||0.507||||||No adjustment for multiple comparison. Significance level of 0.05. Since this endpoint is of an exploratory nature and the significance is well above the threshold, not much more consideration was given to the issue of multiple comparisons|ANOVA|Kruskal-Wallis ANOVA rather than ANOVA since normal distribution of residuals may be suspect.||In order to compare the response between groups, Kruskal-Wallis ANOVA was used.||||0.507
72419830|NCT01422408|144350807|OTHER|||||||0.3676||||||No adjustment for multiple comparison. Significance level of 0.05. Since this endpoint is of an exploratory nature and the significance is well above the threshold, not much more consideration was given to the issue of multiple comparisons|ANOVA|Kruskal-Wallis ANOVA rather than ANOVA since normal distribution of residuals may be suspect.||In order to compare the response between groups, Kruskal-Wallis ANOVA was used.||||0.3676
72419831|NCT01422408|144350808|OTHER|||||||0.6023||||||No adjustment for multiple comparison. Significance level of 0.05. Since this endpoint is of an exploratory nature and the significance is well above the threshold, not much more consideration was given to the issue of multiple comparisons|ANOVA|Kruskal-Wallis ANOVA rather than ANOVA since normal distribution of residuals may be suspect.||In order to compare the response between groups, Kruskal-Wallis ANOVA was used.||||0.6023
72614337|NCT02555878|144758810|SUPERIORITY||Hazard Ratio (HR)|1.96|||=|0.265|TWO_SIDED|95.0|0.59|6.49|||Log Rank|||||6.49|0.59|= 0.265
72614338|NCT00768053|144758840|SUPERIORITY_OR_OTHER|||||||0|TWO_SIDED|||||F test for H0: ICC = 0|F test|||Intraclass correlation coefficient (ICC)||||0.000
72327466|NCT02628444|144178603|SUPERIORITY|The superiority was demonstrated if the lower limit of the two-sided 95% CI was greater than 1 between groups (Group 2/Group 1). Overall superiority of Group 2 to Group 1 was demonstrated if individual serotype null hypotheses were rejected.|GMT Ratio|1.03|||||TWO_SIDED|95.0|0.762|1.39||||||Group2/Group1: Serotype 1 (1 year after last vaccination)||1.39|0.762|
72614339|NCT00768053|144758840|SUPERIORITY_OR_OTHER||standard error of measurement|0.65|||||TWO_SIDED|95.0|0.57|0.75||||||Standardized response mean: standard error of measurement||0.75|0.57|
72614340|NCT00768053|144758842|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||t-test for the Pearson correlation|||Week 4||||<0.001
72614341|NCT00768053|144758843|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||t-test for the Pearson correlation|||Week 12||||<0.001
72614342|NCT00768053|144758844|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||t-test for the Pearson correlation|||Time-normalized average||||<0.001
72614343|NCT00768053|144758845|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||t-test for the Pearson correlation|||Week 4||||<0.001
72614344|NCT00768053|144758846|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||t-test for the Pearson correlation|||Week 12||||<0.001
72614345|NCT00768053|144758847|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||t-test for the Pearson correlation|||Time-normalized average||||<0.001
72614346|NCT00768053|144758848|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||paired t-test|A non significant test (p-value ≥ 0.05) would indicate the component had a significant influence to the global EULAR-RAID score.||Comparison of change from baseline between EULAR-RAID score and Pain NRS value||||<0.001
72614347|NCT00768053|144758848|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||paired t-test|A non significant test (p-value ≥ 0.05) would indicate the component had a significant influence to the global EULAR-RAID score.||Comparison of change from baseline between EULAR-RAID score and Functional disability NRS value||||<0.001
72614348|NCT00768053|144758848|SUPERIORITY_OR_OTHER|||||||0.837|TWO_SIDED||||||paired t-test|A non significant test (p-value ≥ 0.05) would indicate the component had a significant influence to the global EULAR-RAID score.||Comparison of change from baseline between EULAR-RAID score and Fatigue NRS value||||0.837
72614349|NCT00768053|144758848|SUPERIORITY_OR_OTHER|||||||0.035|TWO_SIDED||||||paired t-test|A non significant test (p-value ≥ 0.05) would indicate the component had a significant influence to the global EULAR-RAID score.||Comparison of change from baseline between EULAR-RAID score and Sleep NRS value||||0.035
72614350|NCT00768053|144758848|SUPERIORITY_OR_OTHER|||||||0.351|TWO_SIDED||||||paired t-test|A non significant test (p-value ≥ 0.05) would indicate the component had a significant influence to the global EULAR-RAID score.||Comparison of change from baseline between EULAR-RAID score and Physical well-being NRS value||||0.351
72614351|NCT00768053|144758848|SUPERIORITY_OR_OTHER|||||||0.025|TWO_SIDED||||||paired t-test|A non significant test (p-value ≥ 0.05) would indicate the component had a significant influence to the global EULAR-RAID score.||Comparison of change from baseline between EULAR-RAID score and Emotional well-being NRS value||||0.025
72614352|NCT00768053|144758848|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||paired t-test|A non significant test (p-value ≥ 0.05) would indicate the component had a significant influence to the global EULAR-RAID score.||Comparison of change from baseline between EULAR-RAID score and Coping NRS value||||<0.001
72614353|NCT00768053|144758849|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||paired t-test|A non significant test (p-value ≥ 0.05) would indicate the component had a significant influence to the global EULAR-RAID score.||Comparison of change from baseline between EULAR-RAID score and Pain NRS value||||<0.001
72614354|NCT00768053|144758849|SUPERIORITY_OR_OTHER|||||||0.052|TWO_SIDED||||||paired t-test|A non significant test (p-value ≥ 0.05) would indicate the component had a significant influence to the global EULAR-RAID score.||Comparison of change from baseline between EULAR-RAID score and Functional disability NRS value||||0.052
72614355|NCT00768053|144758849|SUPERIORITY_OR_OTHER|||||||0.895|TWO_SIDED||||||paired t-test|A non significant test (p-value ≥ 0.05) would indicate the component had a significant influence to the global EULAR-RAID score.||Comparison of change from baseline between EULAR-RAID score and Fatigue NRS value||||0.895
72614356|NCT00768053|144758849|SUPERIORITY_OR_OTHER|||||||0.153|TWO_SIDED||||||paired t-test|A non significant test (p-value ≥ 0.05) would indicate the component had a significant influence to the global EULAR-RAID score.||Comparison of change from baseline between EULAR-RAID score and Sleep NRS value||||0.153
72614357|NCT00768053|144758849|SUPERIORITY_OR_OTHER|||||||0.029|TWO_SIDED||||||paired t-test|A non significant test (p-value ≥ 0.05) would indicate the component had a significant influence to the global EULAR-RAID score.||Comparison of change from baseline between EULAR-RAID score and Physical well-being NRS value||||0.029
72614358|NCT00768053|144758849|SUPERIORITY_OR_OTHER|||||||0.043|TWO_SIDED||||||paired t-test|A non significant test (p-value ≥ 0.05) would indicate the component had a significant influence to the global EULAR-RAID score.||Comparison of change from baseline between EULAR-RAID score and Emotional well-being NRS value||||0.043
72614359|NCT00768053|144758849|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||paired t-test|A non significant test (p-value ≥ 0.05) would indicate the component had a significant influence to the global EULAR-RAID score.||Comparison of change from baseline between EULAR-RAID score and Coping NRS value||||<0.001
72614360|NCT01164475|144758866|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.91||||0.395|TWO_SIDED|95.0|0.44|9.17|||Regression, Logistic|||The comparison was done using the logistic regression model, adjusted for country and baseline PB CD34+ cell count.||9.17|0.44|0.395
72614361|NCT04603066|144758879|SUPERIORITY||Mean Difference (Final Values)|0.0204257||||0.8651|TWO_SIDED|95.0|-0.2624635|0.2216122|||t-test, 2 sided|||||0.2216122|-0.2624635|0.8651
72614362|NCT04603066|144758880|SUPERIORITY||Mean Difference (Net)|0.01727052||||0.056|TWO_SIDED|95.0|-0.0005895|0.03513063|||t-test, 2 sided|||||0.03513063|-0.0005895|0.056
72614363|NCT03244189|144758937|OTHER||Hazard Ratio (HR)|0.96|||||TWO_SIDED|95.0|0.77|1.2||||||||1.20|0.77|
72614364|NCT03244189|144758938|OTHER||Odds Ratio (OR)|0.99|||||TWO_SIDED|95.0|0.72|1.37||||||||1.37|0.72|
72614365|NCT03244189|144758939|OTHER||Odds Ratio (OR)|1.44|||||TWO_SIDED|95.0|0.91|2.29||||||||2.29|0.91|
72614366|NCT06717399|144758983|OTHER|The number of participants (n=15) was calculated using an effect size of 0.89. This effect size was based on a randomized clinical trial utilizing a structured mindfulness meditation program on moderate sleep disturbances in older adults (Black et al. 2015). A power of 0.8 and a significance level of 0.05 was utilized to calculate the sample size, a minimum of 12 participants is required to demonstrate significance in this study. To account for 20% attrition total participants needed is 15.||||||0.00058|||||||t-test, 2 sided|||"Null Hypothesis:~● There will not be a change in sleep quality after participation in eight mindfulness meditation sessions as measured by the Pittsburgh Sleep Quality Index."||||0.00058
72614367|NCT06717399|144758984|OTHER|||||||0.004|||||||t-test, 2 sided|||||||0.004
72614368|NCT02266576|144758992|OTHER|||||||0.04||||||The linear regression model was used, adjusted for within cohort correlation, within participant correlation, and gender.|Regression, Linear|||Baseline vs month 6||||0.04
72614369|NCT02266576|144758992|OTHER|||||||0.02|||||||Regression, Linear|The linear regression model was used, adjusted for within cohort correlation, within participant correlation, and gender.||Baseline vs month 12||||0.02
72614370|NCT02266576|144758993|OTHER|||||||0.004|||||||Regression, Linear|The linear regression model was used, adjusted for within cohort correlation, within participant correlation, and gender.||Baseline vs month 6 in physical component score||||0.004
72614371|NCT02266576|144758993|OTHER|||||||0.01|||||||Regression, Linear|The linear regression model was used, adjusted for within cohort correlation, within participant correlation, and gender.||Baseline vs month 12 in physical component score||||0.01
72614372|NCT04950686|144759032|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.002|STANDARD_ERROR_OF_MEAN|0.08||0.983|TWO_SIDED||||||Mixed Models Analysis|||||||0.983
72614373|NCT04950686|144759032|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.06|STANDARD_ERROR_OF_MEAN|0.09||0.465|TWO_SIDED||||||Mixed Models Analysis|||||||0.465
72419832|NCT01422408|144350809|OTHER|||||||0.08531||||||No adjustment for multiple comparison. Significance level of 0.05. Since this endpoint is of an exploratory nature and the significance is well above the threshold, not much more consideration was given to the issue of multiple comparisons|ANOVA|Kruskal-Wallis ANOVA rather than ANOVA since normal distribution of residuals may be suspect.||In order to compare the response between groups, Kruskal-Wallis ANOVA was used.||||0.08531
72419833|NCT01422408|144350810|OTHER|||||||0.2011||||||No adjustment for multiple comparison. Significance level of 0.05. Since this endpoint is of an exploratory nature and the significance is well above the threshold, not much more consideration was given to the issue of multiple comparisons|ANOVA|Kruskal-Wallis ANOVA rather than ANOVA since normal distribution of residuals may be suspect.||In order to compare the response between groups, Kruskal-Wallis ANOVA was used.||||0.2011
72419834|NCT01422408|144350811|OTHER|||||||0.1187||||||No adjustment for multiple comparison. Significance level of 0.05. Since this endpoint is of an exploratory nature and the significance is well above the threshold, not much more consideration was given to the issue of multiple comparisons|ANOVA|Kruskal-Wallis ANOVA rather than ANOVA since normal distribution of residuals may be suspect.||In order to compare the response between groups, Kruskal-Wallis ANOVA was used.||||0.1187
72419835|NCT00724152|144350848|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||t-test, 1 sided|||Null hypothesis: The Cognitive Behavioral Therapy group would not demonstrate decreased distress at post-treatment as compared to the Tinnitus Education group on the primary outcome measure (THI) between pre-treatment and post-treatment.||||<0.05
72419836|NCT03266770|144350857|SUPERIORITY||Mean Difference (Final Values)|0.11||||0.83|TWO_SIDED|95.0|-1.07|1.29|||t-test, 2 sided|||||1.29|-1.07|0.83
72419837|NCT01860703|144350868|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.01|||||TWO_SIDED|90.0|1.02|5.01||||||||5.01|1.02|
72419838|NCT01860703|144350874|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.23|||||TWO_SIDED|90.0|3.26|7.19||||||||7.19|3.26|
72419839|NCT01860703|144350877|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|13.42|||||TWO_SIDED|90.0|11.1|15.75||||||||15.75|11.10|
72419840|NCT02453685|144350880|SUPERIORITY_OR_OTHER||Treatment difference at week 32|0.18||||0.0435|TWO_SIDED|95.0|0.01|0.36|||Mixed Models Analysis||"'Treatment difference' refers to BIAsp 30 minus Basal-bolus"|Analysis was performed using mixed model repeated measurements including treatment, region, and strata as fixed effects, HbA1c at baseline as covariate, interactions between all fixed effects and visit and using an unstructured residual covariance matrix.||0.36|0.01|0.0435
72419841|NCT01023568|144350963|NON_INFERIORITY_OR_EQUIVALENCE|The GlideScope and Truview PCD video laryngoscopes were individually assessed for non-inferiority on time to intubation vs direct laryngoscopy at the 0.025 significance level using an a priori specified non-inferiority delta of seven seconds (about 40% of the expected standard deviation of 18 sec and not thought to be clinically important).|Median Difference (Final Values)|14.0|||>|0.99|TWO_SIDED|95.0|7.0|26.0|||Wilcoxon (Mann-Whitney)||Glidescope - direct laryngoscopy|||26|7|>0.99
72419842|NCT01023568|144350963|NON_INFERIORITY_OR_EQUIVALENCE|The GlideScope and Truview PCD video laryngoscopes were individually assessed for non-inferiority on time to intubation vs direct laryngoscopy at the 0.025 significance level using an a priori specified non-inferiority delta of seven seconds (about 40% of the expected standard deviation of 18 sec and not thought to be clinically important).|Median Difference (Final Values)|17.0|||>|0.99|TWO_SIDED|95.0|6.0|28.0|||Wilcoxon (Mann-Whitney)||Truview PCD - direct laryngoscopy|||28|6|>0.99
72419843|NCT01023568|144350964|SUPERIORITY_OR_OTHER|||||||0.28|||||||ANOVA|||||||0.28
72419844|NCT01023568|144350965|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|1.0|||>|0.99|TWO_SIDED|95.0|1.0|2.0|||Wilcoxon (Mann-Whitney)|1-tailed Wilcoxon sum-rank test|"The median difference was Hodges-Lehmann estimation and the confidence intervals were exact confidence limits. The SAS NPAR1WAY procedure was used for test and estimation."|The Cormack-Lehane grade with a grade 1 (best grade) to 4 (worst grade) was analyzed as an ordinal outcome.||2|1|> 0.99
72419845|NCT01023568|144350965|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.18|TWO_SIDED|95.0|0.0|0.0|||Wilcoxon (Mann-Whitney)|1-tailed Wilcoxon sum-rank test|"The median difference was Hodges-Lehmann estimation and the confidence intervals were exact confidence limits. The SAS NPAR1WAY procedure was used for test and estimation."|The Cormack-Lehane grade with a grade 1 (best grade) to 4 (worst grade) was analyzed as an ordinal outcome.||0|0|0.18
72419846|NCT01023568|144350966|SUPERIORITY_OR_OTHER|||||||0.26|||||||ANOVA|||||||0.26
72419847|NCT01023568|144350967|SUPERIORITY_OR_OTHER||||||>|0.99|||||||Chi-squared|||||||>0.99
72419848|NCT00224770|144350968|SUPERIORITY_OR_OTHER||Risk Difference (RD)|5.3|STANDARD_ERROR_OF_MEAN|6.6||0.324|ONE_SIDED|95.0||16.2|||Fisher Exact|One-sided test|MISTIE rate=14.8, 95% upper limit=25.1; medical rate=9.5, 95% upper limit=20.5; comparison considers MISTIE rate minus medical rate.|Null hypothesis is that rate of mortality within 30 days is the same between the two groups. The alternative hypothesis tests whether MISTIE surgical management has a higher rate of mortality than the medical arm.||16.2||0.324
72419849|NCT00224770|144350968|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-2.4|STANDARD_ERROR_OF_MEAN|8.2||0.633|ONE_SIDED|95.0||11.2|||Fisher Exact|One-sided test|ICES rate=7.1, 95% upper limit=29.7; medical rate=9.5, 95% upper limit=20.5; comparison considers ICES rate minus medical rate.|Null hypothesis is that rate of mortality within 30 days is the same between the two groups. The alternative hypothesis tests whether ICES surgical management has a higher rate of mortality than the medical arm.||11.2||0.633
72614374|NCT04950686|144759033|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.05|STANDARD_ERROR_OF_MEAN|0.09||0.579|TWO_SIDED||||||Mixed Models Analysis|||||||0.579
72419850|NCT00224770|144350969|SUPERIORITY_OR_OTHER||Risk Difference (RD)|5.6|STANDARD_ERROR_OF_MEAN|3.1||0.174|ONE_SIDED|95.0||11.7|||Fisher Exact|One-sided test|MISTIE rate=5.6, 95% upper limit=13.7; medical rate=0.0, 95% upper limit=6.9; comparison considers MISTIE rate minus medical rate.|Null hypothesis is that rate of procedure-related mortality within 7 days is the same between the two groups. The alternative hypothesis tests whether MISTIE surgical management has a higher rate of procedure-related mortality than the medical arm.||11.7||0.174
72419851|NCT00224770|144350970|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-2.4|STANDARD_ERROR_OF_MEAN|2.4||0.437|ONE_SIDED|95.0||1.5|||Fisher Exact|One-sided test|MISTIE rate=0.0, 95% upper limit=5.4; medical rate=2.4, 95% upper limit=10.8; comparison considers MISTIE rate minus medical rate.|Null hypothesis is that rate of cerebritis, meningitis and ventriculitis within 30 days is the same between the two groups. The alternative hypothesis tests whether MISTIE surgical management has a higher rate of these infections than medical.||1.5||0.437
72419852|NCT00224770|144350970|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-2.4|STANDARD_ERROR_OF_MEAN|2.4||0.75|ONE_SIDED|95.0||1.5|||Fisher Exact|One-sided test|ICES rate=0.0, 95% upper limit=19.3; medical rate=2.4, 95% upper limit=10.8; comparison considers ICES rate minus medical rate.|Null hypothesis is that rate of cerebritis, meningitis and ventriculitis within 30 days is the same between the two groups. The alternative hypothesis tests whether ICES surgical management has a higher rate of these infections than medical.||1.5||0.750
72419853|NCT00224770|144350971|SUPERIORITY_OR_OTHER||Risk Difference (RD)|3.2|STANDARD_ERROR_OF_MEAN|3.9||0.409|ONE_SIDED|95.0||9.6|||Fisher Exact|One-sided test|MISTIE rate=5.6, 95% upper limit=13.7; medical rate=2.4, 95% upper limit=10.8; comparison considers MISTIE rate minus medical rate|Null hypothesis is that rate of symptomatic rebleeding 72 hours post last dose is the same between the two groups. The alternative hypothesis tests whether MISTIE surgical management has a higher rate of symptomatic rebleeding than the medical arm.||9.6||0.409
72419854|NCT00224770|144350971|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-2.4|STANDARD_ERROR_OF_MEAN|2.4||0.75|ONE_SIDED|95.0||2.2|||Fisher Exact|One-sided test|ICES rate=0.0, 95% upper limit=19.3; medical rate=2.4, 95% upper limit=10.8; comparison considers ICES rate minus medical rate|Null hypothesis is that rate of symptomatic rebleeding 72 hours post last dose is the same between the two groups. The alternative hypothesis tests whether ICES surgical management has a higher rate of symptomatic rebleeding than the medical arm.||2.2||0.750
72419855|NCT00224770|144350972|SUPERIORITY_OR_OTHER|||||||0.468|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|Two-sided test||Null hypothesis is that the distributions of the mRS values for both groups are the same. The alternative hypothesis is that the distributions are not the same.||||0.468
72419856|NCT00224770|144350972|SUPERIORITY_OR_OTHER|||||||0.294|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|Two-sided test||Null hypothesis is that the distributions of the mRS values for both groups are the same. The alternative hypothesis is that the distributions are not the same.||||0.294
72419857|NCT00224770|144350973|SUPERIORITY_OR_OTHER|||||||0.395|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|Two-sided test||Null hypothesis is that the distributions of the mRS values for both groups are the same. The alternative hypothesis is that the distributions are not the same.||||0.395
72419858|NCT00224770|144350973|SUPERIORITY_OR_OTHER|||||||0.175|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|Two-sided test||Null hypothesis is that the distributions of the mRS values for both groups are the same. The alternative hypothesis is that the distributions are not the same.||||0.175
72419859|NCT00224770|144350974|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|Two-sided test||Null hypothesis is that the distributions of percentage of blood clot resolved are the same between the two groups. The alternative hypothesis is that the distributions are not the same.||||<0.0001
72419860|NCT00224770|144350974|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|Two-sided test||Null hypothesis is that the distributions of percentage of blood clot resolved are the same between the two groups. The alternative hypothesis is that the distributions are not the same.||||<0.0001
72419861|NCT00224770|144350975|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Sign test|Two-sided test||Null hypothesis is that the median percent resolved is 0. The alternative hypothesis is that the median percent resolved is not equal to 0.||||<0.0001
72419862|NCT00224770|144350975|SUPERIORITY_OR_OTHER|||||||0.791|TWO_SIDED||||||Sign test|Two-sided||Null hypothesis is that the median percent resolved is 0. The alternative hypothesis is that the median percent resolved is not equal to 0.||||0.791
72419863|NCT00224770|144350976|SUPERIORITY_OR_OTHER||Risk Difference (RD)|10.9|STANDARD_ERROR_OF_MEAN|9.5||0.189|ONE_SIDED|95.0||26.6|||Fisher Exact|One-sided test|MISTIE rate=34.6, 95% upper limit=46.9; medical rate=23.7, 95% upper limit=37.7; comparison considers MISTIE rate minus medical rate.|Null hypothesis is that the proportion with mRS score of 0-3 at 180 days is the same between the two groups. The alternative hypothesis tests whether MISTIE surgical management has a higher proportion than the medical arm.||26.6||0.189
72419864|NCT00224770|144350976|SUPERIORITY_OR_OTHER||Risk Difference (RD)|19.2|STANDARD_ERROR_OF_MEAN|14.9||0.156|ONE_SIDED|95.0||43.7|||Fisher Exact|One-sided test|ICES rate=42.9, 95% upper limit=67.5; medical rate=23.7, 95% upper limit=37.7; comparison considers ICES rate minus medical rate.|Null hypothesis is that the proportion with mRS score of 0-3 at 180 days is the same between the two groups. The alternative hypothesis tests whether ICES surgical management has a higher proportion than the medical arm.||43.7||0.156
72419865|NCT01106430|144350977|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.001||95.0|||||Peto-Peto-Prentice Wilcoxon Test|||||||=0.001
72614375|NCT04950686|144759033|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Median Difference (Net)|-0.07|STANDARD_ERROR_OF_MEAN|0.12||0.536|TWO_SIDED||||||Mixed Models Analysis|||||||0.536
72614376|NCT04950686|144759034|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.04|STANDARD_ERROR_OF_MEAN|0.11||0.745|TWO_SIDED||||||Mixed Models Analysis|||||||0.745
72614377|NCT04950686|144759034|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.005|STANDARD_ERROR_OF_MEAN|0.14||0.972|TWO_SIDED||||||Mixed Models Analysis|||||||0.972
72419866|NCT01106430|144350978|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|18.1||||0.001|TWO_SIDED|95.0|7.5|28.7|||Cochran-Mantel-Haenszel|||||28.7|7.5|0.001
72419867|NCT01106430|144350979|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-6.5|||<|0.001|TWO_SIDED|95.0|-9.3|-3.6|||ANCOVA|||||-3.6|-9.3|<0.001
72419868|NCT01106430|144350980|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.09||||0.046|TWO_SIDED|95.0|-0.17|0.0|||ANCOVA|||||-0.00|-0.17|0.046
72614378|NCT04950686|144759035|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Odds Ratio (OR)|1.12||||0.682|TWO_SIDED|95.0|0.24|5.25|||Mixed Models Analysis|||||5.25|0.24|0.682
72327467|NCT02628444|144178603|SUPERIORITY|The superiority was demonstrated if the lower limit of the two-sided 95% CI was greater than 1 between groups (Group 2/Group 1). Overall superiority of Group 2 to Group 1 was demonstrated if individual serotype null hypotheses were rejected.|GMT Ratio|0.917|||||TWO_SIDED|95.0|0.724|1.16||||||Group2/Group1: Serotype 2 (1 year after last vaccination)||1.16|0.724|
72614379|NCT04950686|144759035|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Odds Ratio (OR)|1.15||||0.63|TWO_SIDED|95.0|0.28|4.69|||Mixed Models Analysis|||||4.69|0.28|0.630
72614380|NCT04950686|144759036|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Odds Ratio (OR)|1.26||||0.418|TWO_SIDED|95.0|0.12|12.82|||Mixed Models Analysis|||||12.82|0.12|0.418
72614381|NCT04950686|144759036|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Odds Ratio (OR)|1.47||||0.194|TWO_SIDED|95.0|0.13|17.29|||Mixed Models Analysis|||||17.29|0.13|0.194
72614382|NCT04950686|144759037|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Odds Ratio (OR)|0.91||||0.731|TWO_SIDED|95.0|0.1|8.07|||Mixed Models Analysis|||||8.07|0.10|0.731
72327468|NCT02628444|144178603|SUPERIORITY|The superiority was demonstrated if the lower limit of the two-sided 95% CI was greater than 1 between groups (Group 2/Group 1). Overall superiority of Group 2 to Group 1 was demonstrated if individual serotype null hypotheses were rejected.|GMT Ratio|0.933|||||TWO_SIDED|95.0|0.742|1.17||||||Group2/Group1: Serotype 3 (1 year after last vaccination)||1.17|0.742|
72419869|NCT00861614|144350986|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.83||||0.0127|TWO_SIDED|95.0|0.71|0.96|||Log Rank||Ipilimumab over placebo|||0.96|0.71|0.0127
72419870|NCT00861614|144350988|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.7|||||TWO_SIDED|95.0|0.61|0.82|||||Ipilimumab over placebo|||0.82|0.61|
72419871|NCT00861614|144350990|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.25|||||TWO_SIDED|95.0|0.02|4.0|||||Ipilimumab over placebo|||4.00|0.02|
72614383|NCT04950686|144759037|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Odds Ratio (OR)|1.08||||0.786|TWO_SIDED|95.0|0.16|7.34|||Mixed Models Analysis|||||7.34|0.16|0.786
72614384|NCT04950686|144759038|SUPERIORITY|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Odds Ratio (OR)|1.11||||0.71|TWO_SIDED|95.0|0.16|7.49|||Mixed Models Analysis|||||7.49|0.16|0.710
72614385|NCT04950686|144759038|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Odds Ratio (OR)|1.16||||0.61|TWO_SIDED|95.0|0.16|8.73|||Mixed Models Analysis|||||8.73|0.16|0.610
72614386|NCT04950686|144759039|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Odds Ratio (OR)|1.37||||0.27|TWO_SIDED|95.0|0.09|20.33|||Mixed Models Analysis|||||20.33|.09|0.270
72614387|NCT04950686|144759039|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Odds Ratio (OR)|1.25||||0.465|TWO_SIDED|95.0|0.08|18.57|||Mixed Models Analysis|||||18.57|0.08|0.465
72419872|NCT00508261|144351034|NON_INFERIORITY|Criterion for non-inferiority: The lower limit of the two-sided standardized asymptotic 95% confidence interval (CI) for the group difference in the percentages of subjects with serum bactericidal antibodies using baby rabbit complement (rSBA) titer ≥1:8 is greater than or equal to the pre-defined clinical limit of -10%.|Difference in percentages|1.64|||||TWO_SIDED|95.0|-0.33|4.71||||||Demonstration of the non-inferiority of Nimenrix vaccine co-administered with combined Infanrix-hexa vaccine given alone in terms of bactericidal antibodies to Neisseria meningitidis serogroup A, at month 1.||4.71|-0.33|
72419873|NCT00508261|144351034|NON_INFERIORITY|Criterion for non-inferiority: The lower limit of the two-sided standardized asymptotic 95% confidence interval (CI) for the group difference in the percentages of subjects with serum bactericidal antibodies using baby rabbit complement (rSBA) titer ≥1:8 is greater than or equal to the pre-defined clinical limit of -10%.|Difference in percentages|2.73|||||TWO_SIDED|95.0|0.73|6.24||||||Demonstration of the non-inferiority of the Nimenrix vaccine co-administered with combined Infanrix-hexa vaccine given alone in terms of bactericidal antibodies to Neisseria meningitidis serogroup C, at month 1.||6.24|0.73|
72614388|NCT04950686|144759040|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Odds Ratio (OR)|0.91||||0.702|TWO_SIDED|95.0|0.07|11.95|||Mixed Models Analysis|||||11.95|0.07|0.702
72614389|NCT04950686|144759040|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Odds Ratio (OR)|1.21||||0.538|TWO_SIDED|95.0|0.19|7.56|||Mixed Models Analysis|||||7.56|0.19|0.538
72614390|NCT04950686|144759041|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.06|STANDARD_ERROR_OF_MEAN|0.04||0.084|TWO_SIDED||||||Mixed Models Analysis|||||||0.084
72614391|NCT04950686|144759041|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.03|STANDARD_ERROR_OF_MEAN|0.04||0.501|TWO_SIDED||||||Mixed Models Analysis|||||||0.501
72614392|NCT04950686|144759042|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.02|STANDARD_ERROR_OF_MEAN|0.03||0.614|TWO_SIDED||||||Mixed Models Analysis|||||||0.614
72614393|NCT04950686|144759042|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.01|STANDARD_ERROR_OF_MEAN|0.03||0.854|TWO_SIDED||||||Mixed Models Analysis|||||||0.854
72614394|NCT04950686|144759043|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.02|STANDARD_ERROR_OF_MEAN|0.03||0.499|TWO_SIDED||||||Mixed Models Analysis|||||||0.499
72614395|NCT04950686|144759043|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.02|STANDARD_ERROR_OF_MEAN|0.04||0.623|TWO_SIDED||||||Mixed Models Analysis|||||||0.623
72614396|NCT04950686|144759044|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Odds Ratio (OR)|0.84||||0.618|TWO_SIDED|95.0|0.14|5.15|||Mixed Models Analysis|||||5.15|0.14|0.618
72614397|NCT04950686|144759044|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Odds Ratio (OR)|1.19||||0.626|TWO_SIDED|95.0|0.1|14.13|||Mixed Models Analysis|||||14.13|0.10|0.626
72614398|NCT04950686|144759045|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Odds Ratio (OR)|1.47||||0.232|TWO_SIDED|95.0|0.23|9.18|||Mixed Models Analysis|||||9.18|0.23|.232
72614399|NCT04950686|144759045|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Odds Ratio (OR)|1.08||||0.811|TWO_SIDED|95.0|0.22|5.38|||Mixed Models Analysis|||||5.38|0.22|0.811
72614400|NCT04950686|144759046|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Odds Ratio (OR)|1.26||||0.427|TWO_SIDED|95.0|0.16|9.94|||Mixed Models Analysis|||||9.94|0.16|0.427
72614401|NCT04950686|144759046|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Odds Ratio (OR)|1.39||||0.337|TWO_SIDED|95.0|0.25|7.68|||Mixed Models Analysis|||||7.68|0.25|0.337
72614402|NCT04950686|144759047|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.09|STANDARD_ERROR_OF_MEAN|0.11||0.419|TWO_SIDED||||||Mixed Models Analysis|||||||0.419
72614403|NCT04950686|144759047|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.03|STANDARD_ERROR_OF_MEAN|0.12||0.808|TWO_SIDED||||||Mixed Models Analysis|||||||0.808
72614404|NCT04950686|144759048|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.06|STANDARD_ERROR_OF_MEAN|0.12||0.616|TWO_SIDED||||||Mixed Models Analysis|||||||0.616
72419874|NCT00508261|144351034|NON_INFERIORITY|Criterion for non-inferiority: The lower limit of the two-sided standardized asymptotic 95% confidence interval (CI) for the group difference in the percentages of subjects with serum bactericidal antibodies using baby rabbit complement (rSBA) titer ≥1:8 is greater than or equal to the pre-defined clinical limit of -10%.|Difference in percentages|1.61|||||TWO_SIDED|95.0|-0.36|4.64||||||Demonstration of the non-inferiority of the Nimenrix vaccine co-administered with combined Infanrix-hexa vaccine given alone in terms of bactericidal antibodies to Neisseria meningitidis serogroup W-135, at month 1.||4.64|-0.36|
72419875|NCT00508261|144351034|NON_INFERIORITY|Criterion for non-inferiority: The lower limit of the two-sided standardized asymptotic 95% confidence interval (CI) for the group difference in the percentages of subjects with serum bactericidal antibodies using baby rabbit complement (rSBA) titer ≥1:8 is greater than or equal to the pre-defined clinical limit of -10%.|Difference in percentages|2.7|||||TWO_SIDED|95.0|0.71|6.18||||||Demonstration of the non-inferiority of the Nimenrix vaccine co-administered with combined Infanrix-hexa vaccine given alone in terms of bactericidal antibodies to Neisseria meningitidis serogroup Y, at month 1.||6.18|0.71|
72419876|NCT00508261|144351035|NON_INFERIORITY|Criterion for non-inferiority (1 month after the first study vaccination): The lower limit of the two-sided 95% CI on the GMC ratio for anti-PT (ELISA) is greater than or equal to a pre-defined clinical limit of delta = 0.67.|Adjusted GMC ratios|0.97|||||TWO_SIDED|95.0|0.83|1.12||||||Demonstration of non-inferiority of combined Infanrix-hexa vaccine co-administered with Nimenrix vaccine to Infanrix-hexa vaccine given alone in terms of geometric mean concentrations (GMCs) of antibodies to pertussis toxoid (PT), at month 1.||1.12|0.83|
72419877|NCT00508261|144351035|NON_INFERIORITY|Criterion for non-inferiority (1 month after the first study vaccination): The lower limit of the two-sided 95% CI on the GMC ratio for anti-FHA (ELISA) is greater than or equal to a pre-defined clinical limit of delta = 0.67.|Adjusted GMC ratios|0.98|||||TWO_SIDED|95.0|0.85|1.13||||||Demonstration of non-inferiority of combined Infanrix-hexa vaccine co-administered with Nimenrix vaccine to Infanrix-hexa vaccine given alone in terms of geometric mean concentrations (GMCs) of antibodies to filamentous haemagglutinin (FHA), at month 1.||1.13|0.85|
72419878|NCT00508261|144351035|NON_INFERIORITY|Criterion for non-inferiority (1 month after the first study vaccination): The lower limit of the two-sided 95% CI on the GMC ratio for anti-PRN (ELISA) is greater than or equal to a pre-defined clinical limit of delta = 0.67.|Adjusted GMC ratios|0.92|||||TWO_SIDED|95.0|0.78|1.1||||||Demonstration of non-inferiority of combined Infanrix-hexa vaccine co-administered with Nimenrix vaccine to Infanrix-hexa vaccine given alone in terms of geometric mean concentrations (GMCs) of antibodies to pertactin (PRN), at month 1.||1.1|0.78|
72419879|NCT00508261|144351036|NON_INFERIORITY|Criterion for non-inferiority (1 month after the first study vaccination): The lower limit of the two-sided standardized asymptotic 95% CI for the group difference in the percentages of subjects with anti-HBs antibody concentrations ≥10 mIU/ml is greater than or equal to the pre-defined clinical limit of -10%.|Difference in percentages|1.22|||||TWO_SIDED|95.0|-1.47|4.6||||||||4.6|-1.47|
72419880|NCT00508261|144351037|NON_INFERIORITY|Criterion for non-inferiority (1 month after the first study vaccination): The lower limit of the two-sided standardized asymptotic 95% CI for the group difference in the percentage of subjects with anti-PRP concentrations (ELISA) ≥1.0 μg/mL is greater than or equal to the pre-defined clinical limit of -10%.|Difference in percentages|1.19|||||TWO_SIDED|95.0|-1.45|4.5||||||||4.5|-1.45|
72419881|NCT00180479|144351063|NON_INFERIORITY_OR_EQUIVALENCE|Sample size calculation for endpoint of in-segment LL at 240 days is based on these assumptions: one-tailed non-inferiority= (δ)=0.025, Power=99%, Randomization ratio 2:1, True mean in-seg. LL is assumed to be 0.24 mm in both arms.|||||<|0.0001|||||||t-test, 1 sided|||Primary endpoint analyzed for intent-to-treat \& per-treatment evaluable pop. Hypothesis test based on per-subject analysis of intent-to-treat pop. using analysis lesion. The null hypothesis evaluated using non-inferiority test with asymptotic test statistic.||||<0.0001
72419882|NCT00180479|144351064|NON_INFERIORITY_OR_EQUIVALENCE|Study had 89% statistical power based on major secondary endpoint to prove non-inferiority of XIENCE® V to TAXUS®, non-inferiority delta=5.5%, true TVF rate 9.4% in both arms with overall 5% alpha (one-sided), assuming 1% subject dropout rate.|||||<|0.0001|||||||t-test, 1 sided|||Null hypothesis was evaluated using a non-inferiority Z statistic. Non-inferiority was defined as a one-sided alpha of 0.05 and a difference in TVF rate of no more than 5.5%.||||<0.0001
72419883|NCT02459262|144351145|OTHER|ANOVA repeated measures: In-transformed antibody concentrations as dependent variable; dose level, time, presence of adjuvant and dose\*time interaction as fixed effects; subjects as random effects||||||0.0193||||||Adjuvant effect at Day 85, the primary immunological endpoint|ANOVA|Adjuvant effect, with higher antibody concentration values after all dose levels of vaccine was significant at all time points (D29, D43, D57, Day 85)||The objectives for Part A were to evaluate the effect of adjuvant and to inform the selection of dose levels for Part B. The study was not powered for inter-group comparisons.||||0.0193
72419884|NCT02459262|144351146|OTHER||||||<|0.0001|||||||ANOVA|||||||<0.0001
72419885|NCT02459262|144351147|OTHER||||||<|0.0001|||||||ANOVA|||||||<0.0001
72614405|NCT04950686|144759048|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.08|STANDARD_ERROR_OF_MEAN|0.12||0.486|TWO_SIDED||||||Mixed Models Analysis|||||||0.486
72419886|NCT00840801|144351149|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|A stratified score test was used to test the non-inferiority with a margin of -10% at 2.5% type I error (one-sided).|||||<|0.001|||||||Stratified score test|||Non-inferiority Test on Seropositive Response Rate||||<0.001
72614406|NCT04950686|144759049|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.06|STANDARD_ERROR_OF_MEAN|0.12||0.638|TWO_SIDED||||||Mixed Models Analysis|||||||0.638
72614407|NCT04950686|144759049|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.17|STANDARD_ERROR_OF_MEAN|0.14||0.226|TWO_SIDED||||||Mixed Models Analysis|||||||0.226
72327469|NCT02628444|144178603|SUPERIORITY|The superiority was demonstrated if the lower limit of the two-sided 95% CI was greater than 1 between groups (Group 2/Group 1). Overall superiority of Group 2 to Group 1 was demonstrated if individual serotype null hypotheses were rejected.|GMT Ratio|0.916|||||TWO_SIDED|95.0|0.75|1.12||||||Group2/Group1: Serotype 4 (1 year after last vaccination)||1.12|0.750|
72327470|NCT02079909|144178640|SUPERIORITY||Mean Difference (Final Values)|-0.84||||0.3919|TWO_SIDED||||||Mixed Models Analysis|||||||0.3919
72327471|NCT02079909|144178641|SUPERIORITY||Mean Difference (Final Values)|0.04||||0.7588|TWO_SIDED||||||Mixed Models Analysis|||||||0.7588
72327472|NCT02079909|144178642|SUPERIORITY||Mean Difference (Final Values)|1.29||||0.3212|TWO_SIDED||||||Mixed Models Analysis|||||||0.3212
72327473|NCT02277249|144178643|SUPERIORITY_OR_OTHER|||||||0.36|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||No power calculation performed given that this was a pilot study. The null hypothesis was that there would be no difference in pain score with injection between the two study arms. The Wilcoxon rank sum test was selected because of the study's small sample size and the non-normal distribution of pain scores. Intention to treat analyses were used.||||0.36
72327474|NCT01869634|144178661|OTHER|Wilcoxon signed-rank test. Paired samples.||||||0.0025|||||||Sign test|||Comparison between HIV positive naïve to ART before and after ART has been done.||||0.0025
72327475|NCT01869634|144178662|OTHER|Two-sample Wilcoxon rank-sum (Mann-Whitney) test||||||0.032|||||||Wilcoxon (Mann-Whitney)|||||||0.032
72327476|NCT01869634|144178662|OTHER|Wilcoxon signed-rank test||||||0.826|||||||Sign test|||Comparison of coronary artery wall thickness before and after ART in the HIV infected participants.||||0.826
72327477|NCT01869634|144178663|OTHER|Two-sample Wilcoxon rank-sum (Mann-Whitney) test|||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||comparison between groups (HIV+ vs HIV-)||||<0.001
72327478|NCT01869634|144178663|OTHER|||||||0.807|||||||Sign test|||Changes in systemic immune activation through IL6||||0.807
72327479|NCT04551898|144178692|SUPERIORITY||Least square Mean|-0.25||||0.4829|TWO_SIDED|90.0|-0.84|0.34|||Mixed Models Analysis|||||0.34|-0.84|0.4829
72327480|NCT04551898|144178692|SUPERIORITY||Least square Mean|-0.51||||0.1739|TWO_SIDED|90.0|-1.13|0.11|||Mixed Models Analysis|||||0.11|-1.13|0.1739
72327481|NCT04551898|144178692|SUPERIORITY||Least square Mean|0.19||||0.6006|TWO_SIDED|90.0|-0.4|0.77|||Mixed Models Analysis|||||0.77|-0.40|0.6006
72327482|NCT04551898|144178692|SUPERIORITY|||||||0.4996||||||H0: there is a flat dose response curve comparing change from baseline to Day 8 in viral load in the Placebo and other BGB-DXP593 dose groups|t-test, 1 sided|MCP Mod was used to test the primary hypothesis and provide 1-sided p-value accordingly.||||||0.4996
72327483|NCT00559104|144178773|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.51||||0.51|TWO_SIDED|95.0|0.07|3.79|||Regression, Cox||"Parameter Dispersion Type: Standard Error of the Parameter Estimate, not of the mean.~Standard Error = 1.02475"|There is no power calculation as this is a phase II study. This is an Event-free Survival, in which an event can be Relapse/Progression, or Death. Censoring can be at the End of follow-up date, or at the End of study date.||3.79|0.07|0.51
72327484|NCT00559104|144178774|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.66||||0.69|TWO_SIDED|95.0|0.09|4.99|||Regression, Cox||"Numerator: Carmustine in the conditioning. Denominator: Irradiation in the conditioning.~Parameter: Hazard ratio. Dispersion: Standard Error of the Hazard Ratio."|Phase II analysis: There was no power calculation.||4.99|0.09|0.69
72327485|NCT00620373|144178784|SUPERIORITY_OR_OTHER|||||||0.016||95.0|||||t-test, 2 sided|||Significant difference p ≤ 0.05||||.016
72327486|NCT00620373|144178784|SUPERIORITY_OR_OTHER|||||||0.07||95.0|||||McNemar|||significant difference p ≤ 0.05||||.07
72327487|NCT00620373|144178785|SUPERIORITY_OR_OTHER|||||||0.016||95.0|||||McNemar|||For all cancers; significant difference p ≤ 0.05||||.016
72327488|NCT00620373|144178785|SUPERIORITY_OR_OTHER|||||||0.07||95.0|||||McNemar|||For all cancers; significant difference p ≤ 0.05||||.07
72327489|NCT00620373|144178785|SUPERIORITY_OR_OTHER|||||||0.063||95.0|||||McNemar|||For invasive cancers; significant difference p ≤ 0.05||||.063
72327490|NCT00620373|144178785|SUPERIORITY_OR_OTHER|||||||0.063||95.0|||||McNemar|||For invasive cancers; significant difference p ≤ 0.05||||.063
72327491|NCT00620373|144178785|SUPERIORITY_OR_OTHER|||||||0.5||95.0|||||McNemar|||For ductal carcinoma in situ; significant difference p ≤ 0.05||||.5
72327492|NCT00620373|144178785|SUPERIORITY_OR_OTHER||||||>|0.99||95.0|||||McNemar|||For ductal carcinoma in situ; significant difference p ≤ 0.05||||>.99
72327493|NCT00620373|144178787|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||McNemar|||significant difference p ≤ 0.05||||<.001
72327494|NCT00620373|144178787|SUPERIORITY_OR_OTHER|||||||0.069||95.0|||||McNemar|||significant difference p ≤ 0.05||||.069
72327495|NCT00620373|144178788|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||McNemar|||significant difference p ≤ 0.05||||<.001
72327496|NCT00620373|144178788|SUPERIORITY_OR_OTHER|||||||0.218||95.0|||||McNemar|||significant difference p ≤ 0.05||||.218
72327497|NCT01891396|144178893|SUPERIORITY|||||||0.0099|||||||ANOVA|||||||0.0099
72327498|NCT01891396|144178894|SUPERIORITY|||||||0.0367|||||||ANOVA|||||||0.0367
72327499|NCT01891396|144178895|SUPERIORITY|||||||0.0289|||||||ANOVA|||||||0.0289
72327500|NCT01891396|144178896|SUPERIORITY|||||||0.0141|||||||ANOVA|||||||0.0141
72327501|NCT01891396|144178897|SUPERIORITY|||||||0.0002|||||||ANOVA|||||||0.0002
72327502|NCT01891396|144178898|SUPERIORITY|||||||0.0533|||||||ANOVA|||||||0.0533
72327503|NCT01891396|144178899|SUPERIORITY|||||||0.0323|||||||ANOVA|||||||0.0323
72327504|NCT01891396|144178900|SUPERIORITY|||||||0.0072|||||||ANOVA|||||||0.0072
72327505|NCT01891396|144178901|SUPERIORITY|||||||0.003|||||||ANOVA|||||||0.0030
72327506|NCT01891396|144178902|SUPERIORITY|||||||0.044|||||||ANOVA|||||||0.0440
72327507|NCT01891396|144178903|SUPERIORITY|||||||0.0579|||||||ANOVA|||||||0.0579
72327508|NCT01891396|144178904|SUPERIORITY|||||||0.0005|||||||ANOVA|||||||0.0005
72327509|NCT01891396|144178905|SUPERIORITY|||||||0.0046|||||||ANOVA|||||||0.0046
72327510|NCT01891396|144178906|SUPERIORITY|||||||0.0029|||||||ANOVA|||||||0.0029
72327511|NCT01891396|144178907|SUPERIORITY|||||||0.0087|||||||ANOVA|||||||0.0087
72327512|NCT01891396|144178908|SUPERIORITY|||||||0.0154|||||||ANOVA|||||||0.0154
72327513|NCT01891396|144178909|SUPERIORITY|||||||0.0227|||||||ANOVA|||||||0.0227
72327514|NCT01891396|144178910|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0002|TWO_SIDED||||||ANOVA|||||||0.0002
72327515|NCT01891396|144178911|SUPERIORITY|||||||0.0148|||||||ANOVA|||||||0.0148
72419887|NCT01242748|144351164|NON_INFERIORITY_OR_EQUIVALENCE|Degarelix was considered to be non-inferior to goserelin with regard to the hazard ratio of PSA PFS failure rates as the upper limit of the two-sided 95% CI of the adjusted hazard ratio was less than the non-inferiority margin of 1.33.|Hazard Ratio (HR)|0.774||||0.1589|TWO_SIDED|95.0|0.542|1.106|||Cox proportional hazard model|||The hazard ratio of PSA PFS failure rates was estimated using the Cox proportional hazard model with time to PSA PFS failure as dependent and treatment as independent variables and adjusted for baseline PSA category, prostate cancer stage, weight and geographical region. Degarelix was to be considered non-inferior to goserelin if the upper limit of the two-sided 95% confidence interval (CI) of the adjusted hazard ratio was less than or equal to the non-inferiority margin of 1.33.||1.106|0.542|0.1589
72419888|NCT01242748|144351165|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.783||||0.1244|TWO_SIDED|95.0|0.574|1.07|||Cox proportional hazard model|||The hazard ratio was estimated using the Cox proportional hazard model.||1.070|0.574|0.1244
72419889|NCT01242748|144351166|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.856|||||TWO_SIDED|95.0|0.58|1.263||||||The hazard ratio was estimated using the Cox proportional hazard model.||1.263|0.580|
72419890|NCT01242748|144351167|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|3.511||||0.0005|TWO_SIDED|95.0|1.739|7.09|||Cox proportional hazard model|||The hazard ratio was estimated using the Cox proportional hazard model.||7.090|1.739|0.0005
72419891|NCT01242748|144351168|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.739||||0.143|TWO_SIDED|95.0|0.493|1.108|||Cox proportional hazard model|||The hazard ratio was estimated using the Cox proportional hazard model.||1.108|0.493|0.143
72419892|NCT01242748|144351169|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.595||||0.2212|TWO_SIDED|95.0|0.259|1.368|||Cox proportional hazard model|||The hazard ratio was estimated using the Cox proportional hazard model.||1.368|0.259|0.2212
72614408|NCT04950686|144759050|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.07|STANDARD_ERROR_OF_MEAN|0.14||0.63|TWO_SIDED||||||Mixed Models Analysis|||||||0.630
72614409|NCT04950686|144759050|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.02|STANDARD_ERROR_OF_MEAN|0.15||0.88|TWO_SIDED||||||Mixed Models Analysis|||||||0.880
72614410|NCT04950686|144759051|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.06|STANDARD_ERROR_OF_MEAN|0.11||0.569|TWO_SIDED||||||Mixed Models Analysis|||||||0.569
72614411|NCT04950686|144759051|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.003|STANDARD_ERROR_OF_MEAN|0.12||0.98|TWO_SIDED||||||Mixed Models Analysis|||||||0.980
72614412|NCT04950686|144759052|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.1|STANDARD_ERROR_OF_MEAN|0.13||0.466|TWO_SIDED||||||Mixed Models Analysis|||||||0.466
72614413|NCT04950686|144759052|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.002|STANDARD_ERROR_OF_MEAN|0.13||0.99|TWO_SIDED||||||Mixed Models Analysis|||||||0.990
72614414|NCT04950686|144759053|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.002|STANDARD_ERROR_OF_MEAN|0.14||0.989|TWO_SIDED||||||Mixed Models Analysis|||||||0.989
72614415|NCT04950686|144759053|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.07|STANDARD_ERROR_OF_MEAN|0.16||0.678|TWO_SIDED||||||Mixed Models Analysis|||||||0.678
72327516|NCT01891396|144178912|SUPERIORITY|||||||0.0113|||||||ANOVA|||||||0.0113
72327517|NCT01891396|144178913|SUPERIORITY|||||||0.0016|||||||ANOVA|||||||0.0016
72327518|NCT01891396|144178914|SUPERIORITY|||||||0.0056|||||||ANOVA|||||||0.0056
72419893|NCT02416492|144351205|SUPERIORITY||Least Square (LS) Mean Difference|6.0|STANDARD_ERROR_OF_MEAN|2.9||0.0401|TWO_SIDED|95.0||||MMRM: Mixed Model for Repeated Measures|Mixed Models Analysis|||Adjusted LS mean and treatment group difference in change from baseline at Week 24 were modeled using an MMRM including the following variables: treatment, visit, treatment by visit interaction, baseline FMMS score, baseline FMMS score by visit interaction, GOS-E score at screening, and GOS-E score at screening by visit interaction.||||0.0401
72419894|NCT02416492|144351206|SUPERIORITY||Least Square (LS) Mean Difference|-0.7||||0.1655|TWO_SIDED|95.0|-1.7|0.3||MMRM: Mixed Model for Repeated Measures|Mixed Models Analysis|||Adjusted LS mean and treatment group difference in change from baseline at Week 24 were modeled using an MMRM including the following variables: treatment, visit, treatment by visit interaction, baseline FMMS score, baseline FMMS score by visit interaction, GOS-E score at screening, and GOS-E score at screening by visit interaction.||0.3|-1.7|0.1655
72327519|NCT01891396|144178915|SUPERIORITY|||||||0.0095|||||||ANOVA|||||||0.0095
72327520|NCT01891396|144178916|SUPERIORITY|||||||0.0136|||||||ANOVA|||||||0.0136
72327521|NCT01891396|144178917|SUPERIORITY|||||||0.0005|||||||ANOVA|||||||0.0005
72327522|NCT01891396|144178918|SUPERIORITY|||||||0.0059|||||||ANOVA|||||||0.0059
72327523|NCT01152788|144178972|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.1||||0.76|TWO_SIDED|95.0|0.6|2.01|||Log Rank|||||2.01|0.6|0.76
72614416|NCT04950686|144759054|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.26|STANDARD_ERROR_OF_MEAN|0.14||0.075|TWO_SIDED||||||Mixed Models Analysis|||||||0.075
72614417|NCT04950686|144759054|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.35|STANDARD_ERROR_OF_MEAN|0.15||0.024|TWO_SIDED||||||Mixed Models Analysis|||||||0.024
72614418|NCT04950686|144759055|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.16|STANDARD_ERROR_OF_MEAN|0.16||0.301|TWO_SIDED||||||Mixed Models Analysis|||||||0.301
72614419|NCT04950686|144759055|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.07|STANDARD_ERROR_OF_MEAN|0.17||0.702|TWO_SIDED||||||Mixed Models Analysis|||||||0.702
72614420|NCT04950686|144759056|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Odds Ratio (OR)|0.76||||0.352|TWO_SIDED|95.0|0.1|6.13|||Mixed Models Analysis|||||6.13|0.10|0.352
72614421|NCT04950686|144759056|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Odds Ratio (OR)|0.82||||0.445|TWO_SIDED|95.0|0.11|6.16|||Mixed Models Analysis|||||6.16|0.11|0.445
72327524|NCT01152788|144178973|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|-1.0|||||TWO_SIDED|95.0|-18.7|16.8||||||||16.8|-18.7|
72327525|NCT01152788|144178974|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.8||||0.55|TWO_SIDED|95.0|0.38|1.68|||Log Rank|||||1.68|0.38|0.55
72614422|NCT04950686|144759057|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Odds Ratio (OR)|0.55||||0.039|TWO_SIDED|95.0|0.12|2.6|||Mixed Models Analysis|||||2.60|0.12|0.039
72614423|NCT04950686|144759057|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Odds Ratio (OR)|0.59||||0.073|TWO_SIDED|95.0|0.17|2.12|||Mixed Models Analysis|||||2.12|0.17|0.073
72614424|NCT04950686|144759058|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Odds Ratio (OR)|0.62||||0.11|TWO_SIDED|95.0|0.13|2.93|||Mixed Models Analysis|||||2.93|0.13|0.110
72614425|NCT04950686|144759058|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Odds Ratio (OR)|0.65||||0.174|TWO_SIDED|95.0|0.11|3.78|||Mixed Models Analysis|||||3.78|0.11|0.174
72614426|NCT04950686|144759059|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.39|STANDARD_ERROR_OF_MEAN|0.31||0.208|TWO_SIDED||||||Mixed Models Analysis|||||||0.208
72614427|NCT04950686|144759059|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.37|STANDARD_ERROR_OF_MEAN|0.35||0.302|TWO_SIDED||||||Mixed Models Analysis|||||||0.302
72614428|NCT04950686|144759060|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.24|STANDARD_ERROR_OF_MEAN|0.35||0.483|TWO_SIDED||||||Mixed Models Analysis|||||||0.483
72614429|NCT04950686|144759060|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.03|STANDARD_ERROR_OF_MEAN|0.3||0.933|TWO_SIDED||||||Mixed Models Analysis|||||||0.933
72614430|NCT04950686|144759061|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.05|STANDARD_ERROR_OF_MEAN|0.32||0.877|TWO_SIDED||||||Mixed Models Analysis|||||||0.877
72614431|NCT04950686|144759061|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.26|STANDARD_ERROR_OF_MEAN|0.32||0.418|TWO_SIDED||||||Mixed Models Analysis|||||||0.418
72614432|NCT04950686|144759062|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Odds Ratio (OR)|2.23||||0.22|TWO_SIDED|95.0|0.05|98.76|||Mixed Models Analysis|||||98.76|0.05|0.220
72614433|NCT04950686|144759062|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Odds Ratio (OR)|1.08|||||TWO_SIDED|95.0|0.1|11.3||||||||11.30|0.10|
72614434|NCT04950686|144759063|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Odds Ratio (OR)|1.48||||0.506|TWO_SIDED|95.0|0.03|63.29|||Mixed Models Analysis|||||63.29|0.03|0.506
72614435|NCT04950686|144759063|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Odds Ratio (OR)|1.15|||||TWO_SIDED|95.0|0.04|36.32||||||||36.32|0.04|
72614436|NCT04950686|144759064|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Odds Ratio (OR)|1.09||||0.877|TWO_SIDED|95.0|0.04|28.37|||Mixed Models Analysis|||||28.37|0.04|0.877
72614437|NCT04950686|144759064|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Odds Ratio (OR)|0.79|||||TWO_SIDED|95.0|0.02|26.92||||||||26.92|0.02|
72614438|NCT04950686|144759065|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.12|STANDARD_ERROR_OF_MEAN|0.04||0.005|TWO_SIDED||||||Mixed Models Analysis|||||||0.005
72614439|NCT04950686|144759065|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.23|STANDARD_ERROR_OF_MEAN|0.05||1e-05|TWO_SIDED||||||Mixed Models Analysis|||||||0.00001
72327526|NCT01152788|144178975|SUPERIORITY_OR_OTHER_LEGACY|||||||0.01|||||||Chi-squared|||||||0.01
72327527|NCT01282866|144178986|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
72614440|NCT04950686|144759066|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.05|STANDARD_ERROR_OF_MEAN|0.05||0.314|TWO_SIDED||||||Mixed Models Analysis|||||||0.314
72614441|NCT04950686|144759066|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.08|STANDARD_ERROR_OF_MEAN|0.06||0.176|TWO_SIDED||||||Mixed Models Analysis|||||||0.176
72614442|NCT04950686|144759067|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.13|STANDARD_ERROR_OF_MEAN|0.05||0.009|TWO_SIDED||||||Mixed Models Analysis|||||||0.009
72614443|NCT04950686|144759067|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.17|STANDARD_ERROR_OF_MEAN|0.07||0.008|TWO_SIDED||||||Mixed Models Analysis|||||||0.008
72614444|NCT04950686|144759068|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.05|STANDARD_ERROR_OF_MEAN|0.04||0.132|TWO_SIDED||||||Mixed Models Analysis|||||||0.132
72614445|NCT04950686|144759068|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.11|STANDARD_ERROR_OF_MEAN|0.04||0.008|TWO_SIDED||||||Mixed Models Analysis|||||||0.008
72614446|NCT04950686|144759069|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.003|STANDARD_ERROR_OF_MEAN|0.05||0.941|TWO_SIDED||||||Mixed Models Analysis|||||||0.941
72614447|NCT04950686|144759069|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.03|STANDARD_ERROR_OF_MEAN|0.05||0.569|TWO_SIDED||||||Mixed Models Analysis|||||||0.569
72614448|NCT04950686|144759070|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.04|STANDARD_ERROR_OF_MEAN|0.04||0.354|TWO_SIDED||||||Mixed Models Analysis|||||||0.354
72614449|NCT04950686|144759070|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.11|STANDARD_ERROR_OF_MEAN|0.05||0.038|TWO_SIDED||||||Mixed Models Analysis|||||||0.038
72614450|NCT04950686|144759071|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.03|STANDARD_ERROR_OF_MEAN|0.05||0.501|TWO_SIDED||||||Mixed Models Analysis|||||||0.501
72614451|NCT04950686|144759071|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.05|STANDARD_ERROR_OF_MEAN|0.06||0.385|TWO_SIDED||||||Mixed Models Analysis|||||||0.385
72614452|NCT04950686|144759072|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.11|STANDARD_ERROR_OF_MEAN|0.06||0.095|TWO_SIDED||||||Mixed Models Analysis|||||||0.095
72614453|NCT04950686|144759072|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.06|STANDARD_ERROR_OF_MEAN|0.07||0.349|TWO_SIDED||||||Mixed Models Analysis|||||||0.349
72614454|NCT04950686|144759073|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.01|STANDARD_ERROR_OF_MEAN|0.06||0.846|TWO_SIDED||||||Mixed Models Analysis|||||||0.846
72614455|NCT04950686|144759073|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.11|STANDARD_ERROR_OF_MEAN|0.07||0.103|TWO_SIDED||||||Mixed Models Analysis|||||||0.103
72614456|NCT04950686|144759074|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.01|STANDARD_ERROR_OF_MEAN|0.05||0.864|TWO_SIDED||||||Mixed Models Analysis|||||||0.864
72614457|NCT04950686|144759074|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.11|STANDARD_ERROR_OF_MEAN|0.06||0.054|TWO_SIDED||||||Mixed Models Analysis|||||||0.054
72614458|NCT04950686|144759075|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.07|STANDARD_ERROR_OF_MEAN|0.05||0.168|TWO_SIDED||||||Mixed Models Analysis|||||||0.168
72614459|NCT04950686|144759075|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.11|STANDARD_ERROR_OF_MEAN|0.06||0.063|TWO_SIDED||||||Mixed Models Analysis|||||||0.063
72614460|NCT04950686|144759076|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.01|STANDARD_ERROR_OF_MEAN|0.05||0.819|TWO_SIDED||||||Mixed Models Analysis|||||||0.819
72327528|NCT02948582|144178990|SUPERIORITY||least squares mean|0.033||||0.1257|TWO_SIDED|95.0|-0.009|0.075|||least squares mean|||"An analysis of covariance was used with change from baseline in trough FEV1 as the response, with factors for center, treatment, period, sequence, baseline FEV1 as a covariate and a random effect for subject nested within sequence.~A sample size of 34 subjects (42 with dropouts) provides 80% power to detect a 0.14L difference in mean change trough FEV1 between 2 groups at an alpha of 0.05 using a 2-tailed t-test and assuming a common standard deviation for change in trough FEV1 of 0.2."||0.075|-0.009|0.1257
72327529|NCT02948582|144178990|SUPERIORITY||least squares mean|0.072||||0.0008|TWO_SIDED|95.0|0.03|0.113|||least squares mean|||"An analysis of covariance was used with change from baseline in trough FEV1 as the response, with factors for center, treatment, period, sequence, baseline FEV1 as a covariate and a random effect for subject nested within sequence.~A sample size of 34 subjects (42 with dropouts) provides 80% power to detect a 0.14L difference in mean change trough FEV1 between 2 groups at an alpha of 0.05 using a 2-tailed t-test and assuming a common standard deviation for change in trough FEV1 of 0.2."||0.113|0.030|0.0008
72614461|NCT04950686|144759076|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.02|STANDARD_ERROR_OF_MEAN|0.06||0.775|TWO_SIDED||||||Mixed Models Analysis|||||||0.775
72614462|NCT04950686|144759077|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.06|STANDARD_ERROR_OF_MEAN|0.03||0.034|TWO_SIDED||||||Mixed Models Analysis|||||||0.034
72614463|NCT04950686|144759077|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.02|STANDARD_ERROR_OF_MEAN|0.05||0.579|TWO_SIDED||||||Mixed Models Analysis|||||||0.579
72614464|NCT04950686|144759078|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.03|STANDARD_ERROR_OF_MEAN|0.04||0.485|TWO_SIDED||||||Mixed Models Analysis|||||||0.485
72614465|NCT04950686|144759078|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.01|STANDARD_ERROR_OF_MEAN|0.05||0.911|TWO_SIDED||||||Mixed Models Analysis|||||||0.911
72614466|NCT04950686|144759079|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.02|STANDARD_ERROR_OF_MEAN|0.04||0.583|TWO_SIDED||||||Mixed Models Analysis|||||||0.583
72614467|NCT04950686|144759079|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.002|STANDARD_ERROR_OF_MEAN|0.04||0.971|TWO_SIDED||||||Mixed Models Analysis|||||||0.971
72614468|NCT04950686|144759080|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.02|STANDARD_ERROR_OF_MEAN|0.04||0.602|TWO_SIDED||||||Mixed Models Analysis|||||||0.602
72614469|NCT04950686|144759080|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.003|STANDARD_ERROR_OF_MEAN|0.04||0.948|TWO_SIDED||||||Mixed Models Analysis|||||||0.948
72614470|NCT04950686|144759081|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.01|STANDARD_ERROR_OF_MEAN|0.04||0.763|TWO_SIDED||||||Mixed Models Analysis|||||||0.763
72614471|NCT04950686|144759081|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.02|STANDARD_ERROR_OF_MEAN|0.04||0.578|TWO_SIDED||||||Mixed Models Analysis|||||||0.578
72614472|NCT04950686|144759082|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.01|STANDARD_ERROR_OF_MEAN|0.04||0.863|TWO_SIDED||||||Mixed Models Analysis|||||||0.863
72614473|NCT04950686|144759082|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.03|STANDARD_ERROR_OF_MEAN|0.04||0.538|TWO_SIDED||||||Mixed Models Analysis|||||||0.538
72327530|NCT02948582|144178990|SUPERIORITY||least squares mean|0.102|||<|0.0001|TWO_SIDED|95.0|0.061|0.144|||least squares mean|||"An analysis of covariance was used with change from baseline in trough FEV1 as the response, with factors for center, treatment, period, sequence, baseline FEV1 as a covariate and a random effect for subject nested within sequence.~A sample size of 34 subjects (42 with dropouts) provides 80% power to detect a 0.14L difference in mean change trough FEV1 between 2 groups at an alpha of 0.05 using a 2-tailed t-test and assuming a common standard deviation for change in trough FEV1 of 0.2."||0.144|0.061|<0.0001
72327531|NCT02948582|144178990|SUPERIORITY||least squares mean|0.108|||<|0.0001|TWO_SIDED|95.0|0.066|0.15|||least squares mean|||"An analysis of covariance was used with change from baseline in trough FEV1 as the response, with factors for center, treatment, period, sequence, baseline FEV1 as a covariate and a random effect for subject nested within sequence.~A sample size of 34 subjects (42 with dropouts) provides 80% power to detect a 0.14L difference in mean change trough FEV1 between 2 groups at an alpha of 0.05 using a 2-tailed t-test and assuming a common standard deviation for change in trough FEV1 of 0.2."||0.150|0.066|<0.0001
72419895|NCT02416492|144351207|SUPERIORITY||Least Square (LS) Mean Difference|2.7||||0.3398|TWO_SIDED|95.0|-2.9|8.3|||Mixed Models Analysis|MMRM included treatment, visit, baseline endpoints \& GOS-E scores, baseline endpoints \& GOS-E by visit interaction, treatment-by-visit interaction||Adjusted LS mean and treatment group difference in change from baseline at Week 24 were modeled using an MMRM including the following variables: treatment, visit, treatment by visit interaction, baseline FMMS score, baseline FMMS score by visit interaction, GOS-E score at screening, and GOS-E score at screening by visit interaction.||8.3|-2.9|0.3398
72419896|NCT02416492|144351208|SUPERIORITY||Least Square (LS) Mean Difference|-2.6||||0.8974|TWO_SIDED|95.0|-42.2|37.1||MMRM: Mixed Model for Repeated Measures|Mixed Models Analysis|||Adjusted LS mean and treatment group difference in change from baseline at Week 24 were modeled using an MMRM including the following variables: treatment, visit, treatment by visit interaction, baseline FMMS score, baseline FMMS score by visit interaction, GOS-E score at screening, and GOS-E score at screening by visit interaction.||37.1|-42.2|0.8974
72419897|NCT02416492|144351209|SUPERIORITY||Least Square (LS) Mean Difference|-0.49||||0.8534|TWO_SIDED|95.0|-5.77|4.8||MMRM: Mixed Model for Repeated Measures|Mixed Models Analysis|MMRM included treatment, visit, baseline endpoints \& GOS-E scores, baseline endpoints \& GOS-E by visit interaction, treatment-by-visit interaction||Change from Baseline in NeuroQOL Upper Extremity Function T Score at Week 24||4.80|-5.77|0.8534
72419898|NCT02416492|144351209|SUPERIORITY||Least Square (LS) Mean Difference|0.41||||0.8443|TWO_SIDED|95.0|-3.78|4.6||MMRM: Mixed Model for Repeated Measures|Mixed Models Analysis|MMRM included treatment, visit, baseline endpoints \& GOS-E scores, baseline endpoints \& GOS-E by visit interaction, treatment-by-visit interaction||Change from Baseline in NeuroQOL Lower Extremity Function T Score at Week 24||4.60|-3.78|0.8443
72419899|NCT03286751|144351211|SUPERIORITY||Ratio of Geometric LSMeans|1.01||||0.5495|TWO_SIDED|95.0|0.974|1.05|||Mixed Models Analysis|||||1.05|0.974|0.5495
72419900|NCT03286751|144351211|SUPERIORITY||Ratio of Geometric LSMeans|1.02||||0.2236|TWO_SIDED|95.0|0.986|1.06|||Mixed Models Analysis|||||1.06|0.986|0.2236
72419901|NCT03286751|144351211|SUPERIORITY||Ratio of Geometric LSMeans|1.03||||0.0727|TWO_SIDED|95.0|0.997|1.07|||Mixed Models Analysis|||||1.07|0.997|0.0727
72419902|NCT03286751|144351212|SUPERIORITY||Ratio of Geometric LSMeans|0.97||||0.5749|TWO_SIDED|95.0|0.87|1.08|||Mixed Models Analysis|||||1.08|0.87|0.5749
72419903|NCT03286751|144351212|SUPERIORITY||Ratio of Geometric LSMeans|0.92||||0.1578|TWO_SIDED|95.0|0.83|1.03|||Mixed Models Analysis|||||1.03|0.83|0.1578
72327532|NCT02948582|144178990|SUPERIORITY||least squares mean|0.098|||<|0.0001|TWO_SIDED|95.0|0.056|0.14|||least squares mean|||"An analysis of covariance was used with change from baseline in trough FEV1 as the response, with factors for center, treatment, period, sequence, baseline FEV1 as a covariate and a random effect for subject nested within sequence.~A sample size of 34 subjects (42 with dropouts) provides 80% power to detect a 0.14L difference in mean change trough FEV1 between 2 groups at an alpha of 0.05 using a 2-tailed t-test and assuming a common standard deviation for change in trough FEV1 of 0.2."||0.140|0.056|<0.0001
72327533|NCT02948582|144178991|SUPERIORITY||least squares mean|0.086|||<|0.0001|TWO_SIDED|95.0|0.05|0.123|||least squares mean|||An analysis of covariance was used with change from baseline in standardized FEV1 AUC0\_12 as the response, with factors for center, treatment, period, sequence, baseline FEV1 as a covariate and a random effect for subject nested within sequence.||0.123|0.050|<0.0001
72419904|NCT03286751|144351212|SUPERIORITY||Ratio of Geometric LSMeans|0.92||||0.1351|TWO_SIDED|95.0|0.83|1.03|||Mixed Models Analysis|||||1.03|0.83|0.1351
72419905|NCT04067401|144351242|SUPERIORITY||Effect size|-0.13||||0.062|TWO_SIDED|95.0|-0.29|0.01|||Mixed Models Analysis|Model adjusts for class (random effect) and sex, age, race/ethnicity, and Air Force component||||.01|-.29|.062
72419906|NCT04067401|144351243|SUPERIORITY||Effect size|-0.23||||0.001|TWO_SIDED|95.0|-0.39|-0.09|||Mixed Models Analysis|Model adjusts for class (random effect) and sex, age, race/ethnicity, and Air Force component||||-.09|-.39|.001
72419907|NCT04067401|144351244|SUPERIORITY||Effect size|-0.16||||0.027|TWO_SIDED|95.0|-0.34|-0.02|||Mixed Models Analysis|Model adjusts for class (random effect) and sex, age, race/ethnicity, and Air Force component||||-.02|-.34|.027
72419908|NCT04067401|144351245|SUPERIORITY||Effect size|-0.24||||0.002|TWO_SIDED|95.0|-0.41|-0.08|||Mixed Models Analysis|Model adjusts for class (random effect) and sex, age, race/ethnicity, and Air Force component||||-.08|-.41|.002
72419909|NCT04067401|144351246|SUPERIORITY||Effect size|0.01||||0.821|TWO_SIDED|95.0|-0.12|0.11|||Mixed Models Analysis|Model adjusts for class (random effect) and sex, age, race/ethnicity, and Air Force component||||.11|-.12|.821
72327534|NCT02948582|144178991|SUPERIORITY||least squares mean|0.151|||<|0.0001|TWO_SIDED|95.0|0.114|0.187|||least squares mean|||An analysis of covariance was used with change from baseline in standardized FEV1 AUC0\_12 as the response, with factors for center, treatment, period, sequence, baseline FEV1 as a covariate and a random effect for subject nested within sequence.||0.187|0.114|<0.0001
72419910|NCT04067401|144351247|SUPERIORITY||Effect size|-0.14||||0.024|TWO_SIDED|95.0|-0.31|-0.02|||Mixed Models Analysis|Model adjusts for class (random effect) and sex, age, race/ethnicity, and Air Force component||||-.02|-.31|.024
72419911|NCT04067401|144351248|SUPERIORITY||Effect size|0.18||||0.012|TWO_SIDED|95.0|0.04|0.29|||Mixed Models Analysis|Model adjusts for class (random effect) and sex, age, race/ethnicity, and Air Force component||||.29|.04|.012
72419912|NCT04067401|144351249|SUPERIORITY||Effect size|0.21||||0.01|TWO_SIDED|95.0|0.05|0.35||Model adjusts for class (random effect) and sex, age, race/ethnicity, and Air Force component|Mixed Models Analysis|||||.35|.05|.010
72419913|NCT00106184|144351308|SUPERIORITY_OR_OTHER||||||=|0.74|TWO_SIDED||||||Log Rank|No confidence intervals as no parameters were estimated.||Proportional hazards model||||=0.74
72419914|NCT00106184|144351309|SUPERIORITY_OR_OTHER||||||>|0.9|TWO_SIDED|95.0|||||Chi-squared|Difference in baseline muscle enzymes therefore tested the difference in the proportions adjusting for the baseline values.||||||>0.90
72419915|NCT00106184|144351310|SUPERIORITY_OR_OTHER||||||>|0.9|||||||Log Rank|||||||>0.90
72419916|NCT02313909|144351311|SUPERIORITY||Hazard Ratio (HR)|1.07||||0.51884|TWO_SIDED|95.0|0.87|1.33|||Log Rank|||Statistical analysis: Stroke + Systemic embolism: Risk reduction was estimated with the stratified Cox proportional hazards model. Hazard ratios (95% confidence interval) as compared to acetylsalicylic acid arm were reported. Rivaroxaban treatment was compared with the Acetylsalicylic acid control group using a stratified log-rank test. P-values (two-sided) as compared to acetylsalicylic acid arm were based on the log-rank test.||1.33|0.87|0.51884
72419917|NCT02313909|144351312|SUPERIORITY||Hazard Ratio (HR)|2.72||||2e-05|TWO_SIDED|95.0|1.68|4.39|||Log Rank|||Statistical analysis: ISTH major bleeding events: Risk reduction was estimated with the stratified Cox proportional hazards model. Hazard ratios (95% confidence interval) as compared to acetylsalicylic acid arm were reported. Rivaroxaban treatment was compared with the Acetylsalicylic acid control group using a stratified log-rank test. P-values (two-sided) as compared to acetylsalicylic acid arm were based on the log-rank test.||4.39|1.68|0.00002
72327535|NCT02948582|144178991|SUPERIORITY||least squares mean|0.156|||<|0.0001|TWO_SIDED|95.0|0.12|0.193|||least squares mean|||An analysis of covariance was used with change from baseline in standardized FEV1 AUC0\_12 as the response, with factors for center, treatment, period, sequence, baseline FEV1 as a covariate and a random effect for subject nested within sequence.||0.193|0.120|<0.0001
72327536|NCT02948582|144178991|SUPERIORITY||least squares mean|0.202|||<|0.0001|TWO_SIDED|95.0|0.165|0.239|||least squares mean|||An analysis of covariance was used with change from baseline in standardized FEV1 AUC0\_12 as the response, with factors for center, treatment, period, sequence, baseline FEV1 as a covariate and a random effect for subject nested within sequence.||0.239|0.165|<0.0001
72327537|NCT02948582|144178991|SUPERIORITY||least squares mean|0.199|||<|0.0001|TWO_SIDED|95.0|0.162|0.235|||least squares mean|||An analysis of covariance was used with change from baseline in standardized FEV1 AUC0\_12 as the response, with factors for center, treatment, period, sequence, baseline FEV1 as a covariate and a random effect for subject nested within sequence.||0.235|0.162|<0.0001
72327538|NCT02948582|144178992|SUPERIORITY||least squares mean|0.058||||0.0028|TWO_SIDED|95.0|0.021|0.095|||least squares mean|||An analysis of covariance was used with change from baseline in standardized FEV1 AUC12\_24 as the response, with factors for center, treatment, period, sequence, baseline FEV1 as a covariate and a random effect for subject nested within sequence.||0.095|0.021|0.0028
72327539|NCT02948582|144178992|SUPERIORITY||least squares mean|0.1|||<|0.0001|TWO_SIDED|95.0|0.063|0.137|||least squares mena|||An analysis of covariance was used with change from baseline in standardized FEV1 AUC12\_24 as the response, with factors for center, treatment, period, sequence, baseline FEV1 as a covariate and a random effect for subject nested within sequence.||0.137|0.063|<0.0001
72327540|NCT02948582|144178992|SUPERIORITY||least squares mean|0.105|||<|0.0001|TWO_SIDED|95.0|0.068|0.142|||least squares mean|||An analysis of covariance was used with change from baseline in standardized FEV1 AUC12\_24 as the response, with factors for center, treatment, period, sequence, baseline FEV1 as a covariate and a random effect for subject nested within sequence.||0.142|0.068|<0.0001
72327541|NCT02948582|144178992|SUPERIORITY||least squares mean|0.135|||<|0.0001|TWO_SIDED|95.0|0.098|0.173|||least squares mean|||An analysis of covariance was used with change from baseline in standardized FEV1 AUC12\_24 as the response, with factors for center, treatment, period, sequence, baseline FEV1 as a covariate and a random effect for subject nested within sequence.||0.173|0.098|<0.0001
72327542|NCT02948582|144178992|SUPERIORITY||least squares mean|0.128|||<|0.0001|TWO_SIDED|95.0|0.091|0.166|||least squares mean|||An analysis of covariance was used with change from baseline in standardized FEV1 AUC12\_24 as the response, with factors for center, treatment, period, sequence, baseline FEV1 as a covariate and a random effect for subject nested within sequence.||0.166|0.091|<0.0001
72327543|NCT00362882|144179008|SUPERIORITY|||||||0.17|||||||Log Rank|||||||0.17
72327544|NCT01964378|144179009|NON_INFERIORITY|Non-inferiority margin of 8 mg. Assuming equal mean values in both the cebranopadol and morphine groups, it was calculated that for the final analysis of the primary endpoint 170 subjects would have been required per treatment arm in the Per Protocol Set using a 2 sample-t-test for 90% power and a 1-sided significance level of α = 0.025.|point-estimate|-7.48|STANDARD_ERROR_OF_MEAN|2.3|<|0.0001|TWO_SIDED|95.0|-12.05|-2.918|||MMRM|||The MMRM (mixed model repeated measurement) model includes fixed effects of pooled country, treatment, week, treatment-by-week interaction, history of opioid intake, baseline pain intensity as covariate \& subject-specific random effects. Dependent variable being the weekly average rescue medication intake.||-2.918|-12.05|< 0.0001
72419918|NCT02313909|144351313|SUPERIORITY||Hazard Ratio (HR)|1.06||||0.56922|TWO_SIDED|95.0|0.87|1.29|||Log Rank|||Statistical analysis: Risk reduction was estimated with the stratified Cox proportional hazards model. Hazard ratios (95% confidence interval) as compared to acetylsalicylic acid arm were reported. Confidence intervals were calculated, if at least 1 event in each treatment arm existed. Rivaroxaban treatment was compared with the Acetylsalicylic acid control group using a stratified log-rank test. P-values (two-sided) as compared to acetylsalicylic acid arm were based on the log-rank test.||1.29|0.87|0.56922
72419919|NCT02313909|144351314|SUPERIORITY||Hazard Ratio (HR)|1.26||||0.22078|TWO_SIDED|95.0|0.87|1.81|||Log Rank|||Risk reduction was estimated with the stratified Cox proportional hazards model. Hazard ratios (95% confidence interval) as compared to acetylsalicylic acid arm were reported. Confidence intervals were calculated, if at least 1 event in each treatment arm existed. Rivaroxaban treatment was compared with the Acetylsalicylic acid control group using a stratified log-rank test. P-values (two-sided) as compared to acetylsalicylic acid arm were based on the log-rank test.||1.81|0.87|0.22078
72419920|NCT02313909|144351315|SUPERIORITY||Hazard Ratio (HR)|1.08||||0.4797|TWO_SIDED|95.0|0.87|1.34|||Log Rank|||Statistical analysis 1: Stroke: Risk reduction was estimated with the stratified Cox proportional hazards model. Hazard ratios (95% confidence interval) as compared to acetylsalicylic acid arm were reported. Rivaroxaban treatment was compared with the Acetylsalicylic acid control group using a stratified log-rank test. P-values (two-sided) as compared to acetylsalicylic acid arm were based on the log-rank test.||1.34|0.87|0.47970
72419921|NCT02313909|144351315|SUPERIORITY||Hazard Ratio (HR)|1.03||||0.78738|TWO_SIDED|95.0|0.83|1.29|||Log Rank|||Statistical analysis 2: Ischemic stroke: Risk reduction was estimated with the stratified Cox proportional hazards model. Hazard ratios (95% confidence interval) as compared to acetylsalicylic acid arm were reported. Rivaroxaban treatment was compared with the Acetylsalicylic acid control group using a stratified log-rank test. P-values (two-sided) as compared to acetylsalicylic acid arm were based on the log-rank test.||1.29|0.83|0.78738
72419922|NCT02313909|144351315|SUPERIORITY||Hazard Ratio (HR)|1.42||||0.14822|TWO_SIDED|95.0|0.88|2.28|||Log Rank|||Statistical analysis 3: Disabling stroke: Risk reduction was estimated with the stratified Cox proportional hazards model. Hazard ratios (95% confidence interval) as compared to acetylsalicylic acid arm were reported. Rivaroxaban treatment was compared with the Acetylsalicylic acid control group using a stratified log-rank test. P-values (two-sided) as compared to acetylsalicylic acid arm were based on the log-rank test.||2.28|0.88|0.14822
72419923|NCT02313909|144351315|SUPERIORITY||Hazard Ratio (HR)|1.48||||0.14051|TWO_SIDED|95.0|0.87|2.52|||Log Rank|||Statistical analysis 4:CV death: Risk reduction was estimated with the stratified Cox proportional hazards model. Hazard ratios (95% confidence interval) as compared to acetylsalicylic acid arm were reported. Rivaroxaban treatment was compared with the Acetylsalicylic acid control group using a stratified log-rank test. P-values (two-sided) as compared to acetylsalicylic acid arm were based on the log-rank test.||2.52|0.87|0.14051
72419924|NCT02313909|144351315|SUPERIORITY||Hazard Ratio (HR)|0.74||||0.34284|TWO_SIDED|95.0|0.39|1.38|||Log Rank|||Statistical analysis 5: Myocardial infarction: Risk reduction was estimated with the stratified Cox proportional hazards model. Hazard ratios (95% confidence interval) as compared to acetylsalicylic acid arm were reported. Rivaroxaban treatment was compared with the Acetylsalicylic acid control group using a stratified log-rank test. P-values (two-sided) as compared to acetylsalicylic acid arm were based on the log-rank test.||1.38|0.39|0.34284
72419925|NCT02313909|144351316|SUPERIORITY||Hazard Ratio (HR)|2.34||||0.00443|TWO_SIDED|95.0|1.28|4.29|||Log Rank|||Statistical analysis: Risk reduction was estimated with the stratified Cox proportional hazards model. Hazard ratios (95% confidence interval) as compared to acetylsalicylic acid arm were reported. Rivaroxaban treatment was compared with the Acetylsalicylic acid control group using a stratified log-rank test. P-values (two-sided) as compared to acetylsalicylic acid arm were based on the log-rank test.||4.29|1.28|0.00443
72419926|NCT02313909|144351317|SUPERIORITY||Hazard Ratio (HR)|1.51||||0.00451|TWO_SIDED|95.0|1.13|2.0|||Log Rank|||Statistical analysis: Risk reduction was estimated with the stratified Cox proportional hazards model. Hazard ratios (95% confidence interval) as compared to acetylsalicylic acid arm were reported. Rivaroxaban treatment was compared with the Acetylsalicylic acid control group using a stratified log-rank test. P-values (two-sided) as compared to acetylsalicylic acid arm were based on the log-rank test.||2.00|1.13|0.00451
72419927|NCT02313909|144351318|SUPERIORITY||Hazard Ratio (HR)|2.01||||0.04409|TWO_SIDED|95.0|1.0|4.02|||Log Rank|||Statistical analysis 1: Risk reduction was estimated with the stratified Cox proportional hazards model. Hazard ratios (95% confidence interval) as compared to acetylsalicylic acid arm were reported. Rivaroxaban treatment was compared with the Acetylsalicylic acid control group using a stratified log-rank test. P-values (two-sided) as compared to acetylsalicylic acid arm were based on the log-rank test.||4.02|1.00|0.04409
72419928|NCT02231177|144351321|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.12|STANDARD_DEVIATION|32.15|||TWO_SIDED|90.0|0.99|1.27|||ANOVA|ANOVA on the logarithmic scale with fixed effect for treatment, period, sequence, centre and random effect for subject within sequence and centre.|The standard deviation is actually the geometric intra-individual coefficient of variation.|Comparison of Olodaterol (Tiotropium+Olodaterol 5/10 μg: Olodaterol 10 µg). No formal testing.||1.27|0.99|
72419929|NCT02231177|144351322|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.11|STANDARD_DEVIATION|27.17|||TWO_SIDED|90.0|1.01|1.22|||ANOVA|ANOVA on the logarithmic scale with fixed effect for treatment, period, sequence, centre and random effect for subject within sequence and centre.|The standard deviation is actually the geometric intra-individual coefficient of variation.|Comparison of Olodaterol (Tiotropium+Olodaterol 5/10 μg: Olodaterol 10 µg). No formal testing.||1.22|1.01|
72419930|NCT02231177|144351323|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.98|STANDARD_DEVIATION|20.43|||TWO_SIDED|90.0|0.91|1.06|||ANOVA|ANOVA on the logarithmic scale with fixed effect for treatment, period, sequence, centre and random effect for subject within sequence and centre.|The standard deviation is actually the geometric intra-individual coefficient of variation.|Comparison of Tiotropium (Tiotropium+Olodaterol 5/10 μg: Tiotropium 5 µg). No formal testing.||1.06|0.91|
72419931|NCT02231177|144351324|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.05|STANDARD_DEVIATION|19.85|||TWO_SIDED|90.0|0.98|1.13|||ANOVA|ANOVA on the logarithmic scale with fixed effect for treatment, period, sequence, centre and random effect for subject within sequence and centre.|The standard deviation is actually the geometric intra-individual coefficient of variation.|Comparison of Olodaterol (Tiotropium+Olodaterol 5/10 μg: Olodaterol 10 µg). No formal testing.||1.13|0.98|
72614474|NCT04950686|144759083|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.62|STANDARD_ERROR_OF_MEAN|1.41||0.662|TWO_SIDED||||||Mixed Models Analysis|||||||0.662
72419932|NCT02231177|144351325|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.9|STANDARD_DEVIATION|19.81|||TWO_SIDED|90.0|0.83|0.98|||ANOVA|ANOVA on the logarithmic scale with fixed effect for treatment, period, sequence, centre and random effect for subject within sequence and centre.|The standard deviation is actually the geometric intra-individual coefficient of variation.|Comparison of Tiotropium (Tiotropium+Olodaterol 5/10 μg: Tiotropium 5 µg). No formal testing.||0.98|0.83|
72419933|NCT02231177|144351326|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.96|STANDARD_DEVIATION|29.92|||TWO_SIDED|90.0|0.87|1.07|||ANOVA|ANOVA on the logarithmic scale with fixed effect for treatment, period, sequence, centre and random effect for subject within sequence and centre.|The standard deviation is actually the geometric intra-individual coefficient of variation.|Comparison of Tiotropium (Tiotropium+Olodaterol 5/10 μg : Tiotropium 5 µg). No formal testing.||1.07|0.87|
72419934|NCT02231177|144351327|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.02|STANDARD_DEVIATION|21.33|||TWO_SIDED|90.0|0.93|1.12|||ANOVA|ANOVA on the logarithmic scale with fixed effect for treatment, period, sequence, centre and random effect for subject within sequence and centre.|The standard deviation is actually the geometric intra-individual coefficient of variation.|Comparison of Olodaterol (Tiotropium+Olodaterol 5/10 μg : Olodaterol 10 µg). No formal testing.||1.12|0.93|
72419935|NCT02231177|144351328|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.91|STANDARD_DEVIATION|22.61|||TWO_SIDED|90.0|0.84|1.0|||ANOVA|ANOVA on the logarithmic scale with fixed effect for treatment, period, sequence, centre and random effect for subject within sequence and centre.|The standard deviation is actually the geometric intra-individual coefficient of variation.|Comparison of Tiotropium (Tiotropium+Olodaterol 5/10 μg : Tiotropium 5 µg). No formal testing.||1.00|0.84|
72614475|NCT04950686|144759083|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-1.51|STANDARD_ERROR_OF_MEAN|1.81||0.406|TWO_SIDED||||||Mixed Models Analysis|||||||0.406
72419936|NCT02231177|144351329|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.32|STANDARD_DEVIATION|96.12|||TWO_SIDED|90.0|0.98|1.77|||ANOVA|ANOVA on the logarithmic scale with fixed effect for treatment, period, sequence, centre and random effect for subject within sequence and centre.|The standard deviation is actually the geometric intra-individual coefficient of variation.|Comparison of Olodaterol (Tiotropium+Olodaterol 5/10 μg; Olodaterol 10 µg). No formal testing.||1.77|0.98|
72369758|NCT02840799|144249845|SUPERIORITY||Mean Difference (Final Values)|-0.1309108|STANDARD_ERROR_OF_MEAN|0.2619326||0.6191|TWO_SIDED|95.0|-0.6552259|0.3934043||A two-sided α=0.05 was determined by the power calculation.|t-test, 2 sided|t = -0.49979, df = 58. N=59 due to analyzing participants with complete data for Phase 1 and Phase 2 that crossovered.|Only participants that successfully crossed over were included in the t-test (N=59).|We considered an increase in peak VO2 of \~0.6 ml/kg/min to be the minimum clinically significant change. Assuming a 90% retention rate, enrolling 84 subjects in this cross-over trial will have 80% power to detect such an effect size in the intervention induced change of our study endpoints with a two-sided α=0.05. PASS11157 was used to perform power calculations.||0.3934043|-0.6552259|0.6191
72614476|NCT04950686|144759084|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-2.66|STANDARD_ERROR_OF_MEAN|1.64||0.105|TWO_SIDED||||||Mixed Models Analysis|||||||0.105
72614477|NCT04950686|144759084|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-1.33|STANDARD_ERROR_OF_MEAN|1.91||0.487|TWO_SIDED||||||Mixed Models Analysis|||||||0.487
72614478|NCT04950686|144759085|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-2.3|STANDARD_ERROR_OF_MEAN|1.68||0.171|TWO_SIDED||||||Mixed Models Analysis|||||||0.171
72614479|NCT04950686|144759085|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-2.06|STANDARD_ERROR_OF_MEAN|1.9||0.278|TWO_SIDED||||||Mixed Models Analysis|||||||0.278
72614480|NCT04950686|144759086|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.04|STANDARD_ERROR_OF_MEAN|0.04||0.283|TWO_SIDED||||||Mixed Models Analysis|||||||0.283
72614481|NCT04950686|144759086|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.01|STANDARD_ERROR_OF_MEAN|0.05||0.824|TWO_SIDED||||||Mixed Models Analysis|||||||0.824
72614482|NCT04950686|144759087|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.002|STANDARD_ERROR_OF_MEAN|0.04||0.965|TWO_SIDED||||||Mixed Models Analysis|||||||0.965
72614483|NCT04950686|144759087|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.01|STANDARD_ERROR_OF_MEAN|0.05||0.902|TWO_SIDED||||||Mixed Models Analysis|||||||0.902
72614484|NCT04950686|144759088|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.07|STANDARD_ERROR_OF_MEAN|0.04||0.074|TWO_SIDED||||||Mixed Models Analysis|||||||0.074
72614485|NCT04950686|144759088|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.01|STANDARD_ERROR_OF_MEAN|0.05||0.828|TWO_SIDED||||||Mixed Models Analysis|||||||0.828
72614486|NCT04950686|144759089|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.24|STANDARD_ERROR_OF_MEAN|0.25||0.336|TWO_SIDED||||||Mixed Models Analysis|||||||0.336
72614487|NCT04950686|144759089|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.03|STANDARD_ERROR_OF_MEAN|0.28||0.902|TWO_SIDED||||||Mixed Models Analysis|||||||0.902
72614488|NCT04950686|144759090|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.12|STANDARD_ERROR_OF_MEAN|0.24||0.629|TWO_SIDED||||||Mixed Models Analysis|||||||0.629
72614489|NCT04950686|144759090|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.29|STANDARD_ERROR_OF_MEAN|0.29||0.318|TWO_SIDED||||||Mixed Models Analysis|||||||0.318
72614490|NCT04950686|144759091|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.04|STANDARD_ERROR_OF_MEAN|0.24||0.863|TWO_SIDED||||||Mixed Models Analysis|||||||0.863
72614491|NCT04950686|144759091|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.3|STANDARD_ERROR_OF_MEAN|0.29||0.299|TWO_SIDED||||||Mixed Models Analysis|||||||0.299
72614492|NCT04950686|144759092|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.1|STANDARD_ERROR_OF_MEAN|0.04||0.01|TWO_SIDED||||||Mixed Models Analysis|||||||0.010
72614493|NCT04950686|144759092|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.07|STANDARD_ERROR_OF_MEAN|0.05||0.119|TWO_SIDED||||||Mixed Models Analysis|||||||0.119
72419937|NCT02231177|144351330|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.99|STANDARD_DEVIATION|72.08|||TWO_SIDED|90.0|0.79|1.24|||ANOVA|ANOVA on the logarithmic scale with fixed effect for treatment, period, sequence, centre and random effect for subject within sequence and centre.|The standard deviation is actually the geometric intra-individual coefficient of variation.|Comparison of Tiotropium (Tiotropium+Olodaterol 5/10 μg; Tiotropium 5 µg). No formal testing.||1.24|0.79|
72419938|NCT00252538|144351352|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||ANOVA|||All statistics employed Statistical Package for Social Science (SPSS) 17.0. Analysis of variances were used to compare viral responses in genotypes of interest, employing Scheffe's post-hoc analyses. Repeated-measure mixed-effect analyses were used to compare changes in subjective symptoms over time, including age, gender, and self identified race as covariates. Kaplan-Meier survival analyses examining time until MDD development were compared using theMantel-Cox log rank test.||||>0.05
72419939|NCT02657317|144351355|SUPERIORITY||Mean Difference (Final Values)|-9.1||||0.001|TWO_SIDED|95.0|-14.4|-3.7|||GLMM|||To detect a medium effect (d = 0.50) at 2-sided α = 0.05, 50 participants were needed in each study arm (total N = 100). We anticipated 30% attrition in each arm. Data for the primary aim were analyzed using generalized linear mixed models adjusting for baseline levels of prognostic variable and using random intercepts at the level of participants. The primary analysis was based on intent-to-treat.||-3.7|-14.4|.001
72419940|NCT02856113|144351375|SUPERIORITY||Least Square (LS) Mean Difference|0.102|STANDARD_DEVIATION|0.3677|=|0.782|TWO_SIDED|95.0|-0.627|0.831||P-values was assessed at 0.05 significance level using MMRM.|MMRM||MMRM:Treatment,scheduled visit,antidiabetic therapy,visit-by-treatment interaction-categorical effects;Baseline HbA1c,visit-by-baseline HbA1c interaction-continuous covariates;unstructured covariance matrix for correlation of repeated measurements.|||0.831|-0.627|=0.782
72419941|NCT02856113|144351376|SUPERIORITY||LS Mean Difference|-0.046|STANDARD_DEVIATION|0.2635|=|0.863|TWO_SIDED|95.0|-0.567|0.476||P-values was assessed at 0.05 significance level using MMRM.|MMRM||MMRM:Treatment,scheduled visit,antidiabetic therapy,visit-by-treatment interaction-categorical effects;Baseline HbA1c,visit-by-baseline HbA1c interaction-continuous covariates;unstructured covariance matrix for correlation of repeated measurements.|Change From Baseline at Week 12||0.476|-0.567|=0.863
72419942|NCT02856113|144351376|SUPERIORITY||LS Mean Difference|0.004|STANDARD_DEVIATION|0.3123|=|0.99|TWO_SIDED|95.0|-0.614|0.622||P-values was assessed at 0.05 significance level using MMRM.|MMRM||MMRM:Treatment,scheduled visit,antidiabetic therapy,visit-by-treatment interaction-categorical effects;Baseline HbA1c,visit-by-baseline HbA1c interaction-continuous covariates;unstructured covariance matrix for correlation of repeated measurements.|Change From Baseline at Week 18||0.622|-0.614|=0.990
72419943|NCT02856113|144351376|SUPERIORITY||LS Mean Difference|-0.412|STANDARD_DEVIATION|0.3664|=|0.264|TWO_SIDED|95.0|-1.139|0.316||P-values was assessed at 0.05 significance level using MMRM.|MMRM||MMRM:Treatment,scheduled visit,antidiabetic therapy,visit-by-treatment interaction-categorical effects;Baseline HbA1c,visit-by-baseline HbA1c interaction-continuous covariates;unstructured covariance matrix for correlation of repeated measurements.|Change From Baseline at Week 39||0.316|-1.139|=0.264
72614494|NCT04950686|144759093|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.06|STANDARD_ERROR_OF_MEAN|0.04||0.161|TWO_SIDED||||||Mixed Models Analysis|||||||0.161
72614495|NCT04950686|144759093|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.09|STANDARD_ERROR_OF_MEAN|0.05||0.087|TWO_SIDED||||||Mixed Models Analysis|||||||0.087
72614496|NCT04950686|144759094|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.01|STANDARD_ERROR_OF_MEAN|0.05||0.81|TWO_SIDED||||||Mixed Models Analysis|||||||0.810
72614497|NCT04950686|144759094|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.01|STANDARD_ERROR_OF_MEAN|0.06||0.901|TWO_SIDED||||||Mixed Models Analysis|||||||0.901
72419944|NCT02856113|144351376|SUPERIORITY||LS Mean Difference|-0.483|STANDARD_DEVIATION|0.4165|=|0.25|TWO_SIDED|95.0|-1.314|0.348||P-values was assessed at 0.05 significance level using MMRM.|MMRM||MMRM:Treatment,scheduled visit,antidiabetic therapy,visit-by-treatment interaction-categorical effects;Baseline HbA1c,visit-by-baseline HbA1c interaction-continuous covariates;unstructured covariance matrix for correlation of repeated measurements.|Change From Baseline at Week 52||0.348|-1.314|=0.250
72614498|NCT04950686|144759095|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.1|STANDARD_ERROR_OF_MEAN|0.07||0.145|TWO_SIDED||||||Mixed Models Analysis|||||||0.145
72614499|NCT04950686|144759095|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.12|STANDARD_ERROR_OF_MEAN|0.07||0.096|TWO_SIDED||||||Mixed Models Analysis|||||||0.096
72614500|NCT04950686|144759096|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.09|STANDARD_ERROR_OF_MEAN|0.08||0.272|TWO_SIDED||||||Mixed Models Analysis|||||||0.272
72614501|NCT04950686|144759096|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.03|STANDARD_ERROR_OF_MEAN|0.08||0.689|TWO_SIDED||||||Mixed Models Analysis|||||||0.689
72419945|NCT03494166|144351387|SUPERIORITY|Key parameter was the coefficient for the trial arm variable in the mixed model, reflecting average difference of group means over time (weeks 1-13).|Mean Difference (Final Values)|-1.31|STANDARD_ERROR_OF_MEAN|1.32||0.31|TWO_SIDED|95.0|-3.9|1.25||P-value was not adjusted for multiple comparisons. A priori threshold for statistical significance was set at .05.|Mixed Models Analysis|Linear mixed effects models were used for 13 repeated measures of symptom severity index, adjusting for baseline value.|The mean of the group that started with SMSH alone minus the mean of the group that started with SMSH+TIPC (average over time).|"The null hypothesis was that the means in two arms were equal, the alternative hypothesis was that the means were not equal.~We planned to randomize 224 survivors in approximately 3:1 ratio in the first randomization; power was 0.92 to detect the adjusted d=0.54 in the comparison of the SMSH and SMSH+TIPC in the first randomization. The planned number of 224 was exceeded because more survivors than planned were determined to have high need for symptom management."||1.25|-3.90|.31
72614502|NCT04950686|144759097|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.02|STANDARD_ERROR_OF_MEAN|0.08||0.824|TWO_SIDED||||||Mixed Models Analysis|||||||0.824
72419946|NCT03494166|144351388|SUPERIORITY|The key parameter was the coefficient for the variable reflecting trial arm from the second randomization in the mixed model. This parameter reflected average difference between means of two groups over time (weeks 5-13).|Mean Difference (Final Values)|-2.18|STANDARD_ERROR_OF_MEAN|3.35||0.52|TWO_SIDED|95.0|-8.91|4.55||The p-value was not adjusted for multiple comparisons. A priori threshold for statistical significance was .05.|Mixed Models Analysis|Linear mixed effects models were used for 9 repeated measures of symptom severity index (weeks 5-13), adjusting for baseline value.|The mean of the group that continued with SMSH alone minus the mean of the group that had TIPC added to the SMSH after week 4.|The null hypothesis was that the means of two groups were equal. The alternative hypothesis was that the means of two groups were not equal. The required sample size was 60 per group for .80 power or greater in two-tailed tests at the 0.05 level of significance using the effect size of Cohen's d=0.54 (adjusted for baseline and repeated measures). The actual sample size was smaller (61 total) due to the higher than planned rate of response to the SMSH alone by week 4.||4.55|-8.91|.52
72419947|NCT03494166|144351389|SUPERIORITY|Key parameter was the coefficient for the trial arm from the first randomization variable in the linear regression model.|Median Difference (Final Values)|-0.41|STANDARD_ERROR_OF_MEAN|1.12||0.71|TWO_SIDED|95.0|-2.63|1.81||P-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was .05.|Regression, Linear||The mean of group that started with SMSH alone minus the mean of the group that started with SMSH+TIPC.|The null hypothesis was that the means of two groups were equal. The alternative hypothesis was that the means of two groups were not equal. Sample size was determined by the power calculation for the primary outcome.||1.81|-2.63|.71
72614503|NCT04950686|144759097|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.1|STANDARD_ERROR_OF_MEAN|0.09||0.271|TWO_SIDED||||||Mixed Models Analysis|||||||0.271
72614504|NCT04950686|144759098|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.03|STANDARD_ERROR_OF_MEAN|0.04||0.391|TWO_SIDED||||||Mixed Models Analysis|||||||0.391
72614505|NCT04950686|144759098|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.002|STANDARD_ERROR_OF_MEAN|0.04||0.952|TWO_SIDED||||||Mixed Models Analysis|||||||0.952
72614506|NCT04950686|144759099|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.004|STANDARD_ERROR_OF_MEAN|0.04||0.925|TWO_SIDED||||||Mixed Models Analysis|||||||0.925
72614507|NCT04950686|144759099|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.07|STANDARD_ERROR_OF_MEAN|0.05||0.153|TWO_SIDED||||||Mixed Models Analysis|||||||0.153
72614508|NCT04950686|144759100|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.03|STANDARD_ERROR_OF_MEAN|0.05||0.495|TWO_SIDED||||||Mixed Models Analysis|||||||0.495
72614509|NCT04950686|144759100|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.07|STANDARD_ERROR_OF_MEAN|0.06||0.229|TWO_SIDED||||||Mixed Models Analysis|||||||0.229
72614510|NCT04950686|144759101|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.01|STANDARD_ERROR_OF_MEAN|0.05||0.753|TWO_SIDED||||||Mixed Models Analysis|||||||0.753
72614511|NCT04950686|144759101|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.05|STANDARD_ERROR_OF_MEAN|0.05||0.35|TWO_SIDED||||||Mixed Models Analysis|||||||0.350
72419948|NCT03494166|144351390|SUPERIORITY|The key parameter was the coefficient for the trial arm from the second randomization variable in linear regression model.|Mean Difference (Final Values)|-0.76|STANDARD_ERROR_OF_MEAN|2.91||0.79|TWO_SIDED|95.0|-6.53|5.01||P-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was .05.|Regression, Linear|The model included the adjustment for baseline value of the outcome.|The mean of the group that continued with SMSH alone minus the mean of the group that had TIPC added to the SMSH after week 4.|The null hypothesis was that the means of two groups were equal. The alternative hypothesis was that the means of two groups were not equal. Sample size was determined by the power calculation for the primary outcome.||5.01|-6.53|.79
72419949|NCT03477279|144351391|SUPERIORITY||Risk Difference (RD)|0.9|||||TWO_SIDED|95.0|-5.6|7.3|||||Couple (HIV+ Women) - Individual (HIV+ Women)|||7.3|-5.6|
72419950|NCT03477279|144351392|SUPERIORITY||Risk Difference (RD)|6.6|||||TWO_SIDED|95.0|-0.8|14.0|||||Couple (HIV+ Women) - Individual (HIV+ Women)|||14.0|-0.8|
72419951|NCT03477279|144351393|SUPERIORITY||Risk Difference (RD)|10.0|||||TWO_SIDED|95.0|-1.7|21.7|||||Male Partners of Women in Couple - Male Partners of Women in Individual|||21.7|-1.7|
72419952|NCT03477279|144351394|SUPERIORITY||Risk Difference (RD)|16.6|||||TWO_SIDED|95.0|0.9|32.3|||||Male Partners of Women in Couple - Male Partners of Women in Individual|||32.3|0.9|
72419953|NCT03477279|144351395|SUPERIORITY||Risk Difference (RD)|15.1|||||TWO_SIDED|95.0|-1.6|31.8||||||||31.8|-1.6|
72614512|NCT04950686|144759102|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.03|STANDARD_ERROR_OF_MEAN|0.05||0.541|TWO_SIDED||||||Mixed Models Analysis|||||||0.541
72614513|NCT04950686|144759102|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.01|STANDARD_ERROR_OF_MEAN|0.05||0.887|TWO_SIDED||||||Mixed Models Analysis|||||||0.887
72614514|NCT04950686|144759103|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.04|STANDARD_ERROR_OF_MEAN|0.05||0.375|TWO_SIDED||||||Mixed Models Analysis|||||||0.375
72614515|NCT04950686|144759103|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.06|STANDARD_ERROR_OF_MEAN|0.06||0.293|TWO_SIDED||||||Mixed Models Analysis|||||||0.293
72614516|NCT04950686|144759104|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-5.97|STANDARD_ERROR_OF_MEAN|1.89||0.002|TWO_SIDED||||||Mixed Models Analysis|||||||0.002
72419954|NCT03477279|144351396|SUPERIORITY||Risk Difference (RD)|-2.4|||||TWO_SIDED|95.0|-13.2|8.5|||||Male Partners of Women in Couple - Male Partners of Women in Individual|||8.5|-13.2|
72419955|NCT03477279|144351397|SUPERIORITY||Risk Difference (RD)|-4.5|||||TWO_SIDED|95.0|-10.0|10.7|||||Couple (HIV+ Women) - Individual (HIV+ Women)|||10.7|-10.0|
72419956|NCT03477279|144351398|OTHER||Odds Ratio (OR)|4.9|||||TWO_SIDED|95.0|1.7|13.9||||||||13.9|1.7|
72419957|NCT02220894|144351436|SUPERIORITY||Hazard Ratio (HR)|0.7||||0.0003|TWO_SIDED|95.0|0.58|0.86||One-sided p-value based on stratified log-rank test|Log Rank||Hazard ratio based on Cox regression model with treatment as a covariate stratified by geographic region (East Asia vs. non-East Asia), ECOG PS (0 vs. 1), and histology (squamous vs. non-squamous).|||0.86|0.58|0.0003
72419958|NCT02220894|144351437|SUPERIORITY||Hazard Ratio (HR)|0.77||||0.0012|TWO_SIDED|95.0|0.65|0.91||One-sided p-value based on stratified log-rank test|Log Rank||Hazard ratio based on Cox regression model with treatment as a covariate stratified by geographic region (East Asia vs. non-East Asia), ECOG PS (0 vs. 1), PD-L1 expression status (TPS=≥50% vs. TPS=1-49%) and histology (squamous vs. non-squamous).|||0.91|0.65|0.0012
72419959|NCT02220894|144351438|SUPERIORITY||Hazard Ratio (HR)|0.82||||0.0013|TWO_SIDED|95.0|0.71|0.93||One-sided p-value based on stratified log-rank test|Log Rank||Hazard ratio based on Cox regression model with treatment as a covariate stratified by geographic region (East Asia vs. non-East Asia), ECOG PS (0 vs. 1), PD-L1 expression status (TPS=≥50% vs. TPS=1-49%) and histology (squamous vs. non-squamous).|||0.93|0.71|0.0013
72419960|NCT02220894|144351439|SUPERIORITY||Hazard Ratio (HR)|0.83||||0.026|TWO_SIDED|95.0|0.69|1.0||One-sided p-value based on stratified log-rank test|Log Rank||Hazard ratio based on Cox regression model with treatment as a covariate stratified by geographic region (East Asia vs. non-East Asia), ECOG PS (0 vs. 1) and histology (squamous vs. non-squamous).|||1.00|0.69|0.0260
72419961|NCT02220894|144351440|SUPERIORITY||Hazard Ratio (HR)|0.94||||0.2134|TWO_SIDED|95.0|0.8|1.1||One-sided p-value based on stratified log-rank test|Log Rank||Hazard ratio based on Cox regression model with treatment as a covariate stratified by geographic region (East Asia vs. non-East Asia), ECOG PS (0 vs. 1), PD-L1 expression status (TPS=≥50% vs. TPS=1-49%) and histology (squamous vs. non-squamous).|||1.10|0.80|0.2134
72419962|NCT02220894|144351441|SUPERIORITY||Hazard Ratio (HR)|1.05||||0.7964|TWO_SIDED|95.0|0.93|1.19||One-sided p-value based on stratified log-rank test|Log Rank||Hazard ratio based on Cox regression model with treatment as a covariate stratified by geographic region (East Asia vs. non-East Asia), ECOG PS (0 vs. 1), PD-L1 expression status (TPS=≥50% vs. TPS=1-49%) and histology (squamous vs. non-squamous).|||1.19|0.93|0.7964
72419963|NCT02220894|144351442|SUPERIORITY||Difference in Percentage (DP)|7.0||||0.0353|TWO_SIDED|95.0|-0.6|14.6||One-sided p-value for testing. H0: difference in percentages=0 vs. H1: difference in percentages \>0|Stratified Miettinen and Nurminen||DP for pembrolizumab vs. chemotherapy based on Miettinen \& Nurminen method stratified by geographic region (East Asia vs. non-East Asia), ECOG PS (0 vs. 1) and histology (squamous vs. nonsquamous).|||14.6|-0.6|0.0353
72419964|NCT02220894|144351443|SUPERIORITY||Difference in Percentage (DP)|4.6||||0.0744|TWO_SIDED|95.0|-1.7|10.9||One-sided p-value for testing. H0: difference in percentages=0 vs. H1: difference in percentages \>0|Stratified Miettinen and Nurminen||DP for pembrolizumab vs. chemotherapy based on Miettinen \& Nurminen method stratified by geographic region (East Asia vs. non-East Asia), ECOG PS (0 vs. 1), PD-L1 expression status (TPS=≥50% vs. TPS=1-49%) and histology (squamous vs. non-squamous).|||10.9|-1.7|0.0744
72419965|NCT02220894|144351444|SUPERIORITY||Difference in Percentage (DP)|0.6||||0.406|TWO_SIDED|95.0|-4.2|5.4||One-sided p-value for testing. H0: difference in percentages=0 vs. H1: difference in percentages \>0|Stratified Miettinen and Nurminen||DP for pembrolizumab vs. chemotherapy based on Miettinen \& Nurminen method stratified by geographic region (East Asia vs. non-East Asia), ECOG PS (0 vs. 1), PD-L1 expression status (TPS=≥50% vs. TPS=1-49%) and histology (squamous vs. non-squamous).|||5.4|-4.2|0.4060
72419966|NCT02532556|144351506|SUPERIORITY||||||<|0.05|||||||Wilcoxan signed-rank test|||||||<0.05
72419967|NCT02532556|144351507|SUPERIORITY||||||<|0.05|||||||Wilcoxan signed-rank test|||||||<0.05
72419968|NCT00696410|144351509|SUPERIORITY_OR_OTHER|||||||0.068|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||p value represents test of paired (within patient) difference||||0.068
72419969|NCT00696410|144351509|SUPERIORITY_OR_OTHER|||||||0.022|||||||Wilcoxon (Mann-Whitney)|||p value tests difference between the marker in CHF patients at time 0 and Health Controls (between group)||||0.022
72419970|NCT00696410|144351510|SUPERIORITY_OR_OTHER|||||||0.71|TWO_SIDED|95.0|||||Sign test|||p value represents test of paired (within patient) difference||||0.71
72419971|NCT00696410|144351510|SUPERIORITY_OR_OTHER|||||||0.33|||||||Wilcoxon (Mann-Whitney)|||p value tests difference between the marker in CHF patients at time 0 and Health Controls (between group)||||0.33
72419972|NCT00696410|144351511|SUPERIORITY_OR_OTHER|||||||0.69|||||||Sign test|||p value represents test of paired (within patient) difference||||0.69
72419973|NCT00696410|144351511|SUPERIORITY_OR_OTHER|||||||0.004|||||||Wilcoxon (Mann-Whitney)|||p value tests difference between the marker in CHF patients at time 0 and Health Controls (between group)||||0.004
72419974|NCT00696410|144351512|SUPERIORITY_OR_OTHER|||||||0.48|||||||Sign test|||p value represents test of paired (within patient) difference||||0.48
72419975|NCT00696410|144351512|SUPERIORITY_OR_OTHER|||||||0.39|||||||Wilcoxon (Mann-Whitney)|||p value tests difference between the marker in CHF patients at time 0 and Health Controls (between group)||||0.39
72419976|NCT00696410|144351513|SUPERIORITY_OR_OTHER|||||||0.92|||||||Sign test|||p value represents test of paired (within patient) difference||||0.92
72419977|NCT00696410|144351513|SUPERIORITY_OR_OTHER|||||||0.22|||||||Wilcoxon (Mann-Whitney)|||p value tests difference between the marker in CHF patients at time 0 and Health Controls (between group)||||0.22
72419978|NCT03017079|144351528|NON_INFERIORITY|a:0.05;β：0.01 P=.046||||||0.05|||||||t-test, 2 sided|||P=.046||||0.05
72419979|NCT03017079|144351529|NON_INFERIORITY|a 0.05|Odds Ratio (OR)|0.05||||0.05|TWO_SIDED||||||t-test, 2 sided|||||||0.05
72419980|NCT03017079|144351530|SUPERIORITY|||||||0.05|||||||Chi-squared, Corrected|||||||0.05
72419981|NCT03017079|144351532|NON_INFERIORITY|According to the rule of a=0.05, P\<0.05 means that the hypothesis was true|||||<|0.05|||||||Chi-squared, Corrected|||||||<0.05
72419982|NCT01345630|144351557|NON_INFERIORITY_OR_EQUIVALENCE|For the analysis of the primary endpoint conducted at Week 48, the alternative hypothesis was to test for non-inferiority of MVC+DRV/r to FTC/TDF+DRV/r with a non-inferiority margin of -10%.|Mean Difference (Final Values)|-9.54|||||TWO_SIDED|95.0|-14.83|-4.24||||||The difference in the percentages between the maraviroc and the emtricitabine/tenofovir treatment arms and the 2-sided 95% confidence interval for the difference was provided using the stratum-adjusted Mantel-Haenszel (MH) method over the two assays and the screening plasma HIV-1 RNA levels (\>=100,000 copies/mL or \<100,000 copies/mL). The sample size was chosen to yield a power of ≥90%. The 95% CIs and mean difference (final values) are presented as percentages above.||-4.24|-14.83|
72419983|NCT01345630|144351565|SUPERIORITY_OR_OTHER||Treatment difference|-0.075|STANDARD_ERROR_OF_MEAN|0.0303|||TWO_SIDED|95.0|-0.1343|-0.0157||||||The difference in proportions of patients with plasma HIV-1 RNA \<50 copies/mL at Week 48 between the \[MVC+DRV/r\] and the \[FTC/TDF+DRV/r\] treatment arms, with two-sided 95% confidence interval, is shown for those patients who were R5 by genotype (including all who were originally randomized to ESTA and were R5 by genotype upon retesting), via the maximum likelihood (ML) method.||-0.0157|-0.1343|
72419984|NCT01345630|144351570|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4||||0.975|TWO_SIDED|95.0|-24.4|23.6|||ANCOVA|||Results were from an ANCOVA model with change from Baseline as the response variable and the following fixed effect model terms: Treatment group, Screening plasma HIV RNA concentration, Screening Tropism Assay, Baseline value of the response variable.||23.6|-24.4|0.9750
72419985|NCT01345630|144351571|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.3|||<|0.0001|TWO_SIDED|95.0|-3.1|-1.5|||ANCOVA|||Results were from ANCOVA model with change from Baseline as the response variable and the following fixed effect model terms: Treatment group, Screening plasma HIV RNA concentration, Screening Tropism Assay, Baseline value of the response variable.||-1.5|-3.1|<0.0001
72419986|NCT01345630|144351572|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|127.7|||<|0.0001|TWO_SIDED|95.0|76.5|178.8|||ANCOVA|||Results were from ANCOVA model with change from baseline as the response variable and the following fixed effect model terms: Treatment group, Screening plasma HIV RNA concentration, Screening Tropism Assay, Baseline value of the response variable.||178.8|76.5|<0.0001
72419987|NCT01345630|144351573|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.1|||<|0.0001|TWO_SIDED|95.0|1.1|3.1|||ANCOVA|||Results were from ANCOVA model with change from Baseline as the response variable and the following fixed effect model terms: Treatment group, Screening plasma HIV RNA concentration, Screening Tropism Assay, Baseline value of the response variable.||3.1|1.1|<0.0001
72614517|NCT04950686|144759104|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-3.08|STANDARD_ERROR_OF_MEAN|2.21||0.163|TWO_SIDED||||||Mixed Models Analysis|||||||0.163
72614518|NCT04950686|144759105|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-5.09|STANDARD_ERROR_OF_MEAN|1.99||0.011|TWO_SIDED||||||Mixed Models Analysis|||||||0.011
72614519|NCT04950686|144759105|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-3.21|STANDARD_ERROR_OF_MEAN|2.27||0.159|TWO_SIDED||||||Mixed Models Analysis|||||||0.159
72614520|NCT04950686|144759106|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-3.83|STANDARD_ERROR_OF_MEAN|2.06||0.064|TWO_SIDED||||||Mixed Models Analysis|||||||0.064
72614521|NCT04950686|144759106|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-3.37|STANDARD_ERROR_OF_MEAN|2.27||0.137|TWO_SIDED||||||Mixed Models Analysis|||||||0.137
72369759|NCT02840799|144249845|SUPERIORITY||Slope|0.1||||0.711|TWO_SIDED|95.0|-0.043|0.62||Assuming a 90% retention rate, enrolling 84 subjects in this cross-over trial will have 80% power to detect such an effect size in the intervention induced change of our study endpoints, with a two-sided α=0.05.|Mixed Models Analysis|||The mixed model analysis provided an assessment of the treatment effect on each continuous outcome of interest while controlling for effects of other covariates such as period, sequence, and a random subject effect.||0.62|-.043|0.711
72369760|NCT02840799|144249846|SUPERIORITY||Mean Difference (Final Values)|2.217657|STANDARD_ERROR_OF_MEAN|2.065196||0.2871|TWO_SIDED|95.0|-1.910612|6.3459261|||t-test, 2 sided|t = 1.0738, df = 62, p-value = 0.2871, N=63 due to analyzing participants with complete data for Phase 1 and Phase 2 that crossovered.||A two-sided α=0.05 was determined by the power calculation.||6.3459261|-1.910612|0.2871
72369761|NCT02840799|144249846|SUPERIORITY||Slope|-2.12||||0.2935|TWO_SIDED|95.0|-6.12|1.88||Assuming a 90% retention rate, enrolling 84 subjects in this cross-over trial will have 80% power to detect such an effect size in the intervention induced change of our study endpoints, with a two-sided α=0.05.|Mixed Models Analysis|||The mixed model analysis provided an assessment of the treatment effect on each continuous outcome of interest while controlling for effects of other covariates such as period, sequence, and a random subject effect. Randomization sequence was not included in the final model due to lack of evidence for a carry over effect. Phase 1 data for participants that did not crossover due to IDS were considered for the model (N=74).||1.88|-6.12|0.2935
72369762|NCT02840799|144249847|SUPERIORITY||Mean Difference (Final Values)|2.1859922|STANDARD_ERROR_OF_MEAN|1.578944||0.171|TWO_SIDED|95.0|-0.9674467|5.3392901||Assuming a 90% retention rate, enrolling 84 subjects in this cross-over trial will have 80% power to detect such an effect size in the intervention induced change of our study endpoints, with a two-sided α=0.05.|t-test, 2 sided|t=1.3844, df=65, p=0.171. N=66 due to analyzing participants with complete data for Phase 1 and Phase 2 that crossover correctly.||||5.3392901|-0.9674467|0.171
72369763|NCT02840799|144249847|SUPERIORITY||Slope|-2.51||||0.113|TWO_SIDED|95.0|-5.62|0.61||Assuming a 90% retention rate, enrolling 84 subjects in this cross-over trial will have 80% power to detect such an effect size in the intervention induced change of our study endpoints, with a two-sided α=0.05.|Mixed Models Analysis|||The mixed model analysis provided an assessment of the treatment effect on each continuous outcome of interest while controlling for effects of other covariates such as period, sequence, and a random subject effect.||0.61|-5.62|0.113
72369764|NCT02840799|144249848|SUPERIORITY||Mean Difference (Final Values)|2.776572|STANDARD_ERROR_OF_MEAN|3.99464||0.4905|TWO_SIDED|95.0|-5.264221|10.817366||Assuming a 90% retention rate, enrolling 84 subjects in this cross-over trial will have 80% power to detect such an effect size in the intervention induced change of our study endpoints, with a two-sided α=0.05.|t-test, 2 sided|t = 0.69507, df=46, p=.4905. N=47 due to only analyzed participants that correctly crossovered.||||10.817366|-5.264221|0.4905
72369765|NCT02840799|144249848|SUPERIORITY||Slope|1.088||||0.796|TWO_SIDED|95.0|-7.3|9.48||Assuming a 90% retention rate, enrolling 84 subjects in this cross-over trial will have 80% power to detect such an effect size in the intervention induced change of our study endpoints, with a two-sided α=0.05.|Mixed Models Analysis|||The mixed model analysis provided an assessment of the treatment effect on each continuous outcome of interest while controlling for effects of other covariates such as period, sequence, and a random subject effect.||9.48|-7.30|0.796
72369766|NCT02840799|144249849|SUPERIORITY||Mean Difference (Final Values)|-38.11189|STANDARD_ERROR_OF_MEAN|43.84245||0.4017|TWO_SIDED|95.0|-133.63637|57.41259|||t-test, 2 sided|t=-0.86929,, df=12, p=0.4017||||57.41259|-133.63637|0.4017
72369767|NCT02840799|144249849|SUPERIORITY||Slope|61.77||||0.183|TWO_SIDED|95.0|-34.15|157.69||Assuming a 90% retention rate, enrolling 84 subjects in this cross-over trial will have 80% power to detect such an effect size in the intervention induced change of our study endpoints, with a two-sided α=0.05.|Mixed Models Analysis|||||157.69|-34.15|0.183
72369768|NCT02840799|144249850|SUPERIORITY||Mean Difference (Final Values)|0.202782|STANDARD_ERROR_OF_MEAN|0.202782||0.5636|TWO_SIDED|95.0|-0.4959279|0.9014918||Assuming a 90% retention rate, enrolling 84 subjects in this cross-over trial will have 80% power to detect such an effect size in the intervention induced change of our study endpoints, with a two-sided α=0.05.|t-test, 2 sided|t=0.58074, df=59, p=0.5636||||0.9014918|-0.4959279|0.5636
72327545|NCT01964378|144179010|NON_INFERIORITY|Non-inferiority margin of 8 mg. Assuming that 65% of the participants are available for the Per Protocol Set, a total of 524 participant would have to be allocated (randomized) to IMP. With 262 participants per group in the Full Analysis Set, the non-inferiority of cebranopadol as compared to morphine sulfate prolonged release could have been demonstrated with at least 98% power and a 1-sided significance level of α = 0.025.|point-estimate|-4.67|STANDARD_ERROR_OF_MEAN|2.3|<|0.0001|TWO_SIDED|95.0|-9.245|-0.099||MMRM model: fixed effects of pooled country, treatment, week, treatment-by-week interaction, opioid intake history, baseline pain intensity as covariate \& subject-specific random effects. Dependent variable: weekly average rescue medication intake.|MMRM (mixed model repeated measurement)|For participants with no data in the Maintenance Phase, the average amount of rescue medication over the last 3 days of titration was imputed.|Non-inferiority of cebranopadol compared with morphine will be established if the upper bound of the resulting 95% confidence interval for the average treatment difference is below the non-inferiority margin of 8mg.|The primary endpoint will be analyzed by means of a mixed-effects model for repeated measures (MMRM), based on observed case weekly averages. Under the assumption of a missing-at-random missing data mechanism, an MMRM does not require an imputation of missing data and can obtain an improved estimate of variance.||-0.099|-9.245|< 0.0001
72327546|NCT01392573|144179023|SUPERIORITY_OR_OTHER||Treatment contrast|-1.05|||<|0.0001|TWO_SIDED|95.0|-1.25|-0.84|||ANCOVA|ANCOVA model with treatment, country and previous antidiabetic treatment as fixed effects and baseline HbA1c value as covariate||||-0.84|-1.25|<0.0001
72327547|NCT03008070|144179025|SUPERIORITY||Risk Ratio (RR)|1.52|||=|0.061|TWO_SIDED|95.0|0.98|2.12|||Cochran-Mantel-Haenszel|||"The primary endpoint was a binary outcome (Yes/No). Responders rates were compared between the placebo and lanifibranor 800 mg at the end of the treatment period (week 24) using a Cochran Mantel Haenzel test stratified on diabetic status at baseline (that was the stratified factors in the randomisation).~The CMH risk ratio is used to estimate the effect size. Patients with missing data are considered as non-responders."||2.12|0.98|=0.061
72327548|NCT03008070|144179025|SUPERIORITY||Risk Ratio (RR)|1.82|||=|0.004|TWO_SIDED|95.0|1.24|2.4|||Cochran-Mantel-Haenszel|||"The primary endpoint was a binary outcome (Yes/No). Responders rates were compared between the placebo and lanifibranor 1200 mg at the end of the treatment period (week 24) using a Cochran Mantel Haenzel test stratified on diabetic status at baseline (that was the stratified factors in the randomisation).~The CMH risk ratio is used to estimate the effect size. Patients with missing data are considered as non-responders."||2.4|1.24|=0.004
72327549|NCT00841412|144179053|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.76|||<|0.05|TWO_SIDED|95.0|0.59|0.96|||Mixed Models Analysis||The above results are for just one of multiple feeding assistance care process measures: proportion of meals during which residents received assistance to eat baseline to post intervention.|||0.96|0.59|<0.05
72327550|NCT04409834|144179054|SUPERIORITY|"Stratified Win-Ratio Analysis, 2-sided~* The estimated win ratio is calculated by taking the total number of wins in the FDAC arm divided by the total number of wins in the SDPAC arm. A win ratio greater than 1 was in favor of the FDAC arm.~* The win ratio methodology is explained in the following reference Pocock et al. Eur Heart J 2012;33:176-82 (doi:10.1093/eurheartj/ehr352)."|Win Ratio|1.95||||0.028|TWO_SIDED|95.0|1.08|3.55|||Stratified Win-Ratio Analysis, 2-sided|||FDAC = Full Dose Anticoagulation; SDPAC = Standard Dose Prophylactic Anticoagulation||3.55|1.08|0.028
72419988|NCT01345630|144351574|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.11|||<|0.0001|TWO_SIDED|95.0|-0.15|-0.07|||ANCOVA|||Results are from an ANCOVA model with change from Baseline as the response variable and the following fixed effect model terms: Treatment group, Screening plasma HIV RNA concentration, Screening Tropism Assay, Baseline value of the response variable.||-0.07|-0.15|<0.0001
72614522|NCT04950686|144759107|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-5.05|STANDARD_ERROR_OF_MEAN|1.52||0.001|TWO_SIDED||||||Mixed Models Analysis|||||||0.001
72614523|NCT04950686|144759107|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-3.25|STANDARD_ERROR_OF_MEAN|1.76||0.065|TWO_SIDED||||||Mixed Models Analysis|||||||0.065
72614524|NCT04950686|144759108|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-3.67|STANDARD_ERROR_OF_MEAN|1.51||0.015|TWO_SIDED||||||Mixed Models Analysis|||||||0.015
72614525|NCT04950686|144759108|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-2.56|STANDARD_ERROR_OF_MEAN|1.78||0.152|TWO_SIDED||||||Mixed Models Analysis|||||||0.152
72327551|NCT04409834|144179055|SUPERIORITY|"Stratified Win-Ratio Analysis, 2-sided~* The estimated win ratio is calculated by taking the total number of wins in the FDAC arm divided by the total number of wins in the SDPAC arm. A win ratio greater than 1 was in favor of the FDAC arm.~* The win ratio methodology is explained in the following reference Pocock et al. Eur Heart J 2012;33:176-82 (doi:10.1093/eurheartj/ehr352)."|Win Ratio|1.79||||0.087|TWO_SIDED|95.0|0.92|3.47|||Stratified Win-Ratio Analysis, 2-sided|||FDAC = Full Dose Anticoagulation; SDPAC = Standard Dose Prophylactic Anticoagulation||3.47|0.92|0.087
72327552|NCT04409834|144179056|SUPERIORITY|"Stratified Win-Ratio Analysis, 2-sided~* The estimated win ratio is calculated by taking the total number of wins in the Anti-platelet arm divided by the total number of wins in the No Anti-platelet arm. A win ratio greater than 1 was in favor of the Anti-platelet arm.~* The win ratio methodology is explained in the following reference Pocock et al. Eur Heart J 2012;33:176-82 (doi:10.1093/eurheartj/ehr352)."|Win Ratio|1.04||||0.9|TWO_SIDED|95.0|0.54|2.01|||Stratified Win-Ratio Analysis, 2-sided|||||2.01|0.54|0.90
72614526|NCT04950686|144759109|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-3.78|STANDARD_ERROR_OF_MEAN|1.78||0.034|TWO_SIDED||||||Mixed Models Analysis|||||||0.034
72614527|NCT04950686|144759109|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-3.13|STANDARD_ERROR_OF_MEAN|1.84||0.09|TWO_SIDED||||||Mixed Models Analysis|||||||0.090
72614528|NCT04950686|144759110|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.05|STANDARD_ERROR_OF_MEAN|0.04||0.282|TWO_SIDED||||||Mixed Models Analysis|||||||0.282
72614529|NCT04950686|144759110|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.03|STANDARD_ERROR_OF_MEAN|0.05||0.532|TWO_SIDED||||||Mixed Models Analysis|||||||0.532
72614530|NCT04950686|144759111|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.02|STANDARD_ERROR_OF_MEAN|0.05||0.675|TWO_SIDED||||||Mixed Models Analysis|||||||0.675
72327553|NCT04409834|144179057|SUPERIORITY|"Stratified Win-Ratio Analysis, 2-sided~* The estimated win ratio is calculated by taking the total number of wins in the Anti-platelet arm divided by the total number of wins in the No Anti-platelet arm. A win ratio greater than 1 was in favor of the Anti-platelet arm.~* The win ratio methodology is explained in the following reference Pocock et al. Eur Heart J 2012;33:176-82 (doi:10.1093/eurheartj/ehr352)."|Win Ratio|0.79||||0.53|TWO_SIDED|95.0|0.38|1.65|||Stratified Win-Ratio Analysis, 2-sided|||||1.65|0.38|0.53
72327554|NCT00928187|144179079|NON_INFERIORITY_OR_EQUIVALENCE|Hypothesizing 80% efficacy at the 50 copies/mL Viral Load (VL) threshold in the control group at W48, we calculated a required sample size of 150 participants per group to show non-inferiority of ABC/ddI and DRV groups compared with control group in ITT analysis, with a non-inferiority margin of 15%, a power of 90% and a two-sided α of 5%.|differences in proportions|5.6|||||TWO_SIDED|95.0|-5.1|16.4||||||||16.4|-5.1|
72327555|NCT00928187|144179079|NON_INFERIORITY_OR_EQUIVALENCE|Hypothesizing 80% efficacy at the 50 copies/mL VL threshold in the control group at W48, we calculated a required sample size of 150 participants per group to show non-inferiority of ABC/ddI and DRV groups compared with control group in ITT analysis, with a non-inferiority margin of 15%, a power of 90% and a two-sided α of 5%.|difference in proportions|6.1|||||TWO_SIDED|95.0|-4.5|16.7||||||||16.7|-4.5|
72327556|NCT00928187|144179084|SUPERIORITY_OR_OTHER|||||||0.001|||||||Chi-squared|||||||0.001
72327557|NCT00928187|144179085|SUPERIORITY_OR_OTHER|||||||0.26|||||||Chi-squared|||||||0.26
72327558|NCT00928187|144179086|SUPERIORITY_OR_OTHER|||||||0.13|||||||Chi-squared|||||||0.13
72327559|NCT01682356|144179092|SUPERIORITY|||||||0.0153|||||||t-test, 2 sided|Paired||||||0.0153
72327560|NCT01682356|144179093|SUPERIORITY|||||||0.0131|||||||t-test, 2 sided|Paired||||||0.0131
72327561|NCT01682356|144179094|SUPERIORITY|||||||0.83||||||P value adjusted for multiplicity|ANOVA|Plasma nitrate values were analyzed using a repeated measures ANOVA followed by Holm-Šídák multiple comparison testing||||||0.83
72327562|NCT01682356|144179095|SUPERIORITY||||||<|1e-07||||||P values adjusted for multiplicity. Exact P value 6.06 x 10\^-18.|ANOVA|Plasma nitrate values were analyzed using a repeated measures ANOVA followed by Holm-Šídák multiple comparison testing||||||<0.0000001
72614531|NCT04950686|144759111|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.04|STANDARD_ERROR_OF_MEAN|0.06||0.443|TWO_SIDED||||||Mixed Models Analysis|||||||0.443
72327563|NCT01682356|144179096|SUPERIORITY||||||<|1e-07||||||P values adjusted for multiplicity. Exact P value 1.87 x 10\^-20.|ANOVA|Plasma nitrate values were analyzed using a repeated measures ANOVA followed by Holm-Šídák multiple comparison testing||||||<0.0000001
72327564|NCT01682356|144179097|SUPERIORITY||||||<|1e-07||||||P values adjusted for multiplicity. Exact P value 8.23 x 10\^-21.|ANOVA|Plasma nitrate values were analyzed using a repeated measures ANOVA followed by Holm-Šídák multiple comparison testing||||||<0.0000001
72327565|NCT01682356|144179098|SUPERIORITY|||||||0.6847||||||P values adjusted for multiplicity|ANOVA|Plasma nitrate values were analyzed using a repeated measures ANOVA followed by Holm-Šídák multiple comparison testing||||||0.6847
72327566|NCT01682356|144179099|SUPERIORITY|||||||0.6847||||||P values adjusted for multiplicity|ANOVA|Plasma nitrate values were analyzed using a repeated measures ANOVA followed by Holm-Šídák multiple comparison testing||||||0.6847
72327567|NCT01682356|144179100|SUPERIORITY|||||||0.4078||||||P values adjusted for multiplicity|ANOVA|Plasma nitrate values were analyzed using a repeated measures ANOVA followed by Holm-Šídák multiple comparison testing||||||0.4078
72327568|NCT01682356|144179101|SUPERIORITY|||||||0.4078||||||P values adjusted for multiplicity|ANOVA|Plasma nitrate values were analyzed using a repeated measures ANOVA followed by Holm-Šídák multiple comparison testing||||||0.4078
72327569|NCT01682356|144179102|SUPERIORITY|||||||0.3042||||||P value adjusted for multiplicity|ANOVA|Breath nitric oxide values were analyzed using a repeated measures ANOVA followed by Holm-Šídák multiple comparison testing||||||0.3042
72419989|NCT01345630|144351575|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|75.861||||0.8379|TWO_SIDED|95.0|-658.181|809.903|||ANCOVA|||Results are from ANCOVA model with change from Baseline as the response variable and the following fixed effect model terms: treatment group, age, race, Screening BMI, and Baseline value of the response variable. Treatment differences are estimated using LS means with factor levels weighted according to overall analysis population proportions.||809.903|-658.181|0.8379
72419990|NCT01345630|144351576|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.031||||0.3376|TWO_SIDED|95.0|-0.033|0.094|||ANCOVA|||Results are from ANCOVA model with change from Baseline as the response variable and the following fixed effect model terms: treatment group, age, race, Screening BMI, and Baseline value of the response variable. Treatment differences are estimated using LS means with factor levels weighted according to overall analysis population proportions.||0.094|-0.033|0.3376
72419991|NCT01345630|144351577|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.014||||0.0043|TWO_SIDED|95.0|0.004|0.023|||ANCOVA|||Results are from ANCOVA model with change from Baseline as the response variable and the following fixed effect model terms: treatment group, age, race, Screening BMI, and Baseline value of the response variable. Treatment differences are estimated using LS means with factor levels weighted according to overall analysis population proportions.||0.023|0.004|0.0043
72419992|NCT01345630|144351578|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.008||||0.2273|TWO_SIDED|95.0|-0.005|0.022|||ANCOVA|||Results are from ANCOVA model with change from Baseline as the response variable and the following fixed effect model terms: treatment group, age, race, Screening BMI, and Baseline value of the response variable. Treatment differences are estimated using LS means with factor levels weighted according to overall analysis population proportions.||0.022|-0.005|0.2273
72419993|NCT01345630|144351579|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.005||||0.4188|TWO_SIDED|95.0|-0.007|0.018|||ANCOVA|||Results are from ANCOVA model with change from Baseline as the response variable and the following fixed effect model terms: treatment group, age, race, Screening BMI, and Baseline value of the response variable. Treatment differences are estimated using LS means with factor levels weighted according to overall analysis population proportions.||0.018|-0.007|0.4188
72419994|NCT01345630|144351580|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.12||||0.1722|TWO_SIDED|95.0|-5.17|0.94|||ANCOVA|||Results are from ANCOVA model with change from Baseline as the response variable and the following fixed effect model terms: treatment group, age, race, Screening BMI, and Baseline value of the response variable. Treatment differences are estimated using LS means with factor levels weighted according to overall analysis population proportions.||0.94|-5.17|0.1722
72419995|NCT01345630|144351581|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-126.78||||0.0071|TWO_SIDED|95.0|-218.34|-35.23|||ANCOVA|||Results are from an ANCOVA model with change from Baseline as the response variable and the following fixed effect model terms: treatment group, age, race, Screening BMI, Baseline value of the response variable. Treatment differences are estimated using LS means with factor levels weighted according to overall analysis population proportions.||-35.23|-218.34|0.0071
72419996|NCT03938454|144351589|OTHER||Hodges-Lehmann|45.98||||0.0676|TWO_SIDED|95.0|23.5|65.36||P-value is from one-sided Wilcoxon Sign Rank Test with at least 25% percent reduction from Baseline (adjusted for 26 weeks) as outcome variable.|Wilcoxon Sign Rank Test|||||65.36|23.50|0.0676
72327570|NCT01682356|144179103|SUPERIORITY||||||<|1e-07||||||P value adjusted for multiplicity. Exact P value 3.469 x 10\^-7.|ANOVA|Breath nitric oxide values were analyzed using a repeated measures ANOVA followed by Holm-Šídák multiple comparison testing||||||<0.0000001
72419997|NCT03938454|144351595|OTHER||Hodges-Lehmann|50.2||||0.0259|TWO_SIDED|95.0|27.94|67.36||P-value is from one-sided Wilcoxon Sign Rank Test with at least 25% reduction from Baseline (adjusted for 26 weeks) as outcome variable.|Wilcoxon Sign Rank Test|||||67.36|27.94|0.0259
72419998|NCT00949884|144351612|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.5|STANDARD_ERROR_OF_MEAN|0.63|<|0.0001|TWO_SIDED|95.0|-3.8|-1.3|||ANCOVA|The ANCOVA model included treatment as a fixed effect and the baseline DBP as a covariate.||Null hypothesis was that there was no difference in change in seated diastolic blood pressure from baseline to end of treatment. Sample size of 900, this study had 90% power to detect a true difference in mean change from baseline in mean trough SDBP of 2.0 mmHg for Combined Olmesartan vs Losartan.||-1.3|-3.8|<0.0001
72419999|NCT00949884|144351613|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.6|STANDARD_ERROR_OF_MEAN|0.88|<|0.0001|TWO_SIDED|95.0|-5.3|-1.8|||ANCOVA|The ANCOVA model included treatment as a fixed effect and baseline SSBP as a covariate.||||-1.8|-5.3|<0.0001
72420000|NCT00949884|144351614|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.9|STANDARD_ERROR_OF_MEAN|0.99||0.0001|TWO_SIDED|95.0|-5.8|-1.9|||ANCOVA|The ANCOVA model included treatment as a fixed effect and baseline SSBP as a covariate.||||-1.9|-5.8|0.0001
72420001|NCT00949884|144351615|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.7|STANDARD_ERROR_OF_MEAN|0.58|<|0.0001|TWO_SIDED|95.0|-3.8|-1.5|||ANCOVA|ANCOVA model included treatment as a fixed effect and baseline blood pressure value as a covariate.||||-1.5|-3.8|<0.0001
72420002|NCT00949884|144351617|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9|STANDARD_ERROR_OF_MEAN|0.55||0.1121|TWO_SIDED|95.0|-2.0|0.2|||ANCOVA|Treatment as a fixed effect and the seated cuff diastolic blood pressure value at week 4 (with last observation carried forward) as a covariate.||||0.2|-2.0|0.1121
72327571|NCT01682356|144179104|SUPERIORITY||||||<|1e-07||||||P value adjusted for multiplicity. Exact P value 7.202 x 10\^-8|ANOVA|Breath nitric oxide values were analyzed using a repeated measures ANOVA followed by Holm-Šídák multiple comparison testing||||||<0.0000001
72420003|NCT00949884|144351617|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0|STANDARD_ERROR_OF_MEAN|0.54||0.0783|TWO_SIDED|95.0|-2.0|0.1|||ANCOVA|Treatment as a fixed effect and the seated cuff diastolic blood pressure value at week 4 (with last observation carried forward) as a covariate.||||0.1|-2.0|0.0783
72420004|NCT00949884|144351618|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.1|STANDARD_ERROR_OF_MEAN|0.92||0.2312|TWO_SIDED|95.0|-2.9|0.7|||ANCOVA|Treatment as a fixed effect and the seated cuff diastolic blood pressure value at week 4 (with last observation carried forward) as a covariate.||||0.7|-2.9|0.2312
72420005|NCT00949884|144351618|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.5|STANDARD_ERROR_OF_MEAN|0.9||0.0979|TWO_SIDED|95.0|-3.2|0.3|||ANCOVA|Treatment as a fixed effect and the seated cuff diastolic blood pressure value at week 4 (with last observation carried forward) as a covariate.||||0.3|-3.2|0.0979
72420006|NCT00949884|144351619|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Regression, Logistic|The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.||Percentage of participants achieving systolic blood pressure goal of \<140 mmHg||||<0.0001
72420007|NCT00949884|144351619|SUPERIORITY_OR_OTHER|||||||0.0001||95.0|||||Regression, Logistic|The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.||Percentage of participants achieving systolic blood pressure goal of \<140 mmHg||||0.0001
72420008|NCT00949884|144351619|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Regression, Logistic|The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.||Percentage of participants achieving systolic blood pressure goal of \<135 mmHg||||<0.0001
72420009|NCT00949884|144351619|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Regression, Logistic|The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.||Percentage of participants achieving systolic blood pressure goal of \<135 mmHg||||<0.0001
72420010|NCT00949884|144351619|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Regression, Logistic|The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.||Percentage of participants achieving systolic blood pressure goal of \<130 mmHg||||<0.0001
72420011|NCT00949884|144351619|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Regression, Logistic|The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.||Percentage of participants achieving systolic blood pressure goal of \<130 mmHg||||<0.0001
72420012|NCT00949884|144351619|SUPERIORITY_OR_OTHER|||||||0.2755||95.0|||||Regression, Logistic|The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.||Percentage of participants achieving systolic blood pressure goal of \<120 mmHg||||0.2755
72420013|NCT00949884|144351619|SUPERIORITY_OR_OTHER|||||||0.1646||95.0|||||Regression, Logistic|The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.||Percentage of participants achieving systolic blood pressure goal of \<120 mmHg||||0.1646
72420014|NCT00949884|144351619|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Regression, Logistic|The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.||Percentage of participants achieving diastolic blood pressure goal of \<90 mmHg||||<0.0001
72420015|NCT00949884|144351619|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Regression, Logistic|The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.||Percentage of participants achieving diastolic blood pressure goal of \<90 mmHg||||<0.0001
72420016|NCT00949884|144351619|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.|Regression, Logistic|||Percentage of participants achieving diastolic blood pressure goal of \<85 mmHg||||<0.0001
72420017|NCT00949884|144351619|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Regression, Logistic|The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.||Percentage of participants achieving diastolic blood pressure goal of \<85 mmHg||||<0.0001
72420018|NCT00949884|144351619|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||Regression, Logistic|The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.||Percentage of participants achieving diastolic blood pressure goal of \<80 mmHg||||0.0010
72420019|NCT00949884|144351619|SUPERIORITY_OR_OTHER|||||||0.0011||95.0|||||Regression, Logistic|The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.||Percentage of participants achieving diastolic blood pressure goal of \<80 mmHg||||0.0011
72327572|NCT01682356|144179105|SUPERIORITY|||||||2.13e-06||||||P value adjusted for multiplicity. Exact P value 2.129 x 10\^-6.|ANOVA|Breath nitric oxide values were analyzed using a repeated measures ANOVA followed by Holm-Šídák multiple comparison testing||||||0.00000213
72420020|NCT00949884|144351619|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Regression, Logistic|The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.||Percentage of participants achieving blood pressure goal of \<140/90 mmHg||||<0.0001
72420021|NCT00949884|144351619|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Regression, Logistic|The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.||Percentage of participants achieving blood pressure goal of \<140/90 mmHg||||<0.0001
72420022|NCT00949884|144351619|SUPERIORITY_OR_OTHER|||||||0.0005||95.0|||||Regression, Logistic|The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.||Percentage of participants achieving blood pressure goal of \<135/80 mmHg||||0.0005
72420023|NCT00949884|144351619|SUPERIORITY_OR_OTHER|||||||0.0004||95.0|||||Regression, Logistic|The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.||Percentage of participants achieving blood pressure goal of \<135/80 mmHg||||0.0004
72420024|NCT00949884|144351619|SUPERIORITY_OR_OTHER|||||||0.0023||95.0|||||Regression, Logistic|The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.||Percentage of participants achieving blood pressure goal of \<130/80 mmHg||||0.0023
72420025|NCT00949884|144351619|SUPERIORITY_OR_OTHER|||||||0.0012||95.0|||||Regression, Logistic|The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.||Percentage of participants achieving blood pressure goal of \<130/80 mmHg||||0.0012
72420026|NCT00949884|144351620|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Regression, Logistic|The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.||Percentage of participants achieving systolic blood pressure goal of \<140 mmHg||||<0.0001
72420027|NCT00949884|144351620|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Regression, Logistic|The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.||Percentage of participants achieving systolic blood pressure goal of \<140 mmHg||||<0.0001
72420028|NCT00949884|144351620|SUPERIORITY_OR_OTHER|||||||0.0009||95.0|||||Regression, Logistic|The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.||Percentage of participants achieving systolic blood pressure goal of \<135 mmHg||||0.0009
72420029|NCT00949884|144351620|SUPERIORITY_OR_OTHER|||||||0.0007||95.0|||||Regression, Logistic|The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.||Percentage of participants achieving systolic blood pressure goal of \<135 mmHg||||0.0007
72420030|NCT00949884|144351620|SUPERIORITY_OR_OTHER|||||||0.0347||95.0|||||Regression, Logistic|The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.||Percentage of participants achieving systolic blood pressure goal of \<130 mmHg||||0.0347
72420031|NCT00949884|144351620|SUPERIORITY_OR_OTHER|||||||0.028||95.0|||||Regression, Logistic|The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.||Percentage of participants achieving systolic blood pressure goal of \<130 mmHg||||0.0280
72420032|NCT00949884|144351620|SUPERIORITY_OR_OTHER|||||||0.0519||95.0|||||Regression, Logistic|The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.||Percentage of participants achieving systolic blood pressure goal of \<120 mmHg||||0.0519
72420033|NCT00949884|144351620|SUPERIORITY_OR_OTHER|||||||0.0605||95.0|||||Regression, Logistic|The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.||Percentage of participants achieving systolic blood pressure goal of \<120 mmHg||||0.0605
72420034|NCT00949884|144351620|SUPERIORITY_OR_OTHER|||||||0.0001||95.0|||||Regression, Logistic|The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.||Percentage of participants achieving diastolic blood pressure goal of \<90 mmHg||||0.0001
72614532|NCT04950686|144759112|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.02|STANDARD_ERROR_OF_MEAN|0.05||0.685|TWO_SIDED||||||Mixed Models Analysis|||||||0.685
72614533|NCT04950686|144759112|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.02|STANDARD_ERROR_OF_MEAN|0.06||0.726|TWO_SIDED||||||Mixed Models Analysis|||||||0.726
72614534|NCT04950686|144759113|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.05|STANDARD_ERROR_OF_MEAN|0.04||0.282|TWO_SIDED||||||Mixed Models Analysis|||||||0.282
72614535|NCT04950686|144759113|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.03|STANDARD_ERROR_OF_MEAN|0.06||0.591|TWO_SIDED||||||Mixed Models Analysis|||||||0.591
72614536|NCT04950686|144759114|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.02|STANDARD_ERROR_OF_MEAN|0.05||0.675|TWO_SIDED||||||Mixed Models Analysis|||||||0.675
72420035|NCT00949884|144351620|SUPERIORITY_OR_OTHER|||||||0.0003||95.0|||||Regression, Logistic|The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.||Percentage of participants achieving diastolic blood pressure goal of \<90 mmHg||||0.0003
72420036|NCT00949884|144351620|SUPERIORITY_OR_OTHER|||||||0.007||95.0|||||Regression, Logistic|The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.||Percentage of participants achieving diastolic blood pressure goal of \<85 mmHg||||0.0070
72420037|NCT00949884|144351620|SUPERIORITY_OR_OTHER|||||||0.0066||95.0|||||Regression, Logistic|The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.||Percentage of participants achieving diastolic blood pressure goal of \<85 mmHg||||0.0066
72420038|NCT00949884|144351620|SUPERIORITY_OR_OTHER|||||||0.0061||95.0|||||Regression, Logistic|The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.||Percentage of participants achieving diastolic blood pressure goal of \<80 mmHg||||0.0061
72420039|NCT00949884|144351620|SUPERIORITY_OR_OTHER|||||||0.0096||95.0|||||Regression, Logistic|The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.||Percentage of participants achieving diastolic blood pressure goal of \<80 mmHg||||0.0096
72420040|NCT00949884|144351620|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Regression, Logistic|The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.||Percentage of participants achieving blood pressure goal of \<140/90 mmHg||||<0.0001
72420041|NCT00949884|144351620|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Regression, Logistic|The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.||Percentage of participants achieving blood pressure goal of \<140/90 mmHg||||<0.0001
72420042|NCT00949884|144351620|SUPERIORITY_OR_OTHER|||||||0.0047||95.0|||||Regression, Logistic|The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.||Percentage of participants achieving blood pressure goal of \<135/80 mmHg||||0.0047
72614537|NCT04950686|144759114|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.07|STANDARD_ERROR_OF_MEAN|0.08||0.359|TWO_SIDED||||||Mixed Models Analysis|||||||0.359
72420043|NCT00949884|144351620|SUPERIORITY_OR_OTHER|||||||0.0063||95.0|||||Regression, Logistic|The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.||Percentage of participants achieving blood pressure goal of \<135/80 mmHg||||0.0063
72614538|NCT04950686|144759115|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.rt-type scale from 1 (strongly disagree) to 4 (strongly agree); higher scores indicate greater self-efficacy to use a dental dam; range = 1-4|Mean Difference (Net)|-0.02|STANDARD_ERROR_OF_MEAN|0.05||0.685|TWO_SIDED||||||Mixed Models Analysis|||||||0.685
72614539|NCT04950686|144759115|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.09|STANDARD_ERROR_OF_MEAN|0.07||0.198|TWO_SIDED||||||Mixed Models Analysis|||||||0.198
72614540|NCT04950686|144759116|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.-type scale from 1 (strongly disagree) to 4 (strongly agree); higher scores indicate greater self-efficacy to use a dental dam; range = 1-4|Mean Difference (Net)|0.05|STANDARD_ERROR_OF_MEAN|0.06||0.46|TWO_SIDED||||||Mixed Models Analysis|||||||0.460
72614541|NCT04950686|144759116|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.01|STANDARD_ERROR_OF_MEAN|0.06||0.822|TWO_SIDED||||||Mixed Models Analysis|||||||0.822
72614542|NCT04950686|144759117|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.03|STANDARD_ERROR_OF_MEAN|0.06||0.671|TWO_SIDED||||||Mixed Models Analysis|||||||0.671
72614543|NCT04950686|144759117|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.01|STANDARD_ERROR_OF_MEAN|0.07||0.939|TWO_SIDED||||||Mixed Models Analysis|||||||0.939
72614544|NCT04950686|144759118|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.03|STANDARD_ERROR_OF_MEAN|0.06||0.655|TWO_SIDED||||||Mixed Models Analysis|||||||0.655
72614545|NCT04950686|144759118|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.07|STANDARD_ERROR_OF_MEAN|0.07||0.315|TWO_SIDED||||||Mixed Models Analysis|||||||0.315
72614546|NCT04950686|144759119|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.002|STANDARD_ERROR_OF_MEAN|0.04||0.966|TWO_SIDED||||||Mixed Models Analysis|||||||0.966
72614547|NCT04950686|144759119|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.02|STANDARD_ERROR_OF_MEAN|0.05||0.708|TWO_SIDED||||||Mixed Models Analysis|||||||0.708
72614548|NCT04950686|144759120|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.006|STANDARD_ERROR_OF_MEAN|0.04||0.887|TWO_SIDED||||||Mixed Models Analysis|||||||0.887
72614549|NCT04950686|144759120|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.01|STANDARD_ERROR_OF_MEAN|0.05||0.077|TWO_SIDED||||||Mixed Models Analysis|||||||0.077
72614550|NCT04950686|144759121|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.05|STANDARD_ERROR_OF_MEAN|0.04||0.217|TWO_SIDED||||||Mixed Models Analysis|||||||0.217
72614551|NCT04950686|144759121|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.01|STANDARD_ERROR_OF_MEAN|0.05||0.879|TWO_SIDED||||||Mixed Models Analysis|||||||0.879
72327573|NCT01682356|144179106|SUPERIORITY|||||||0.3918||||||P values adjusted for multiplicity|ANOVA|Values for blood pressure were analyzed using a repeated measures ANOVA followed by Holm-Šídák multiple comparison testing||||||0.3918
72420044|NCT00949884|144351620|SUPERIORITY_OR_OTHER|||||||0.0589||95.0|||||Regression, Logistic|The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates||Percentage of participants achieving blood pressure goal of \<130/80 mmHg||||0.0589
72327574|NCT01682356|144179107|SUPERIORITY|||||||0.0598||||||P values adjusted for multiplicity|ANOVA|Values for blood pressure were analyzed using a repeated measures ANOVA followed by Holm-Šídák multiple comparison testing||||||0.05980
72327575|NCT01682356|144179108|SUPERIORITY|||||||0.3918||||||P values adjusted for multiplicity|ANOVA|Values for blood pressure were analyzed using a repeated measures ANOVA followed by Holm-Šídák multiple comparison testing||||||0.3918
72420045|NCT00949884|144351620|SUPERIORITY_OR_OTHER|||||||0.0594||95.0|||||Regression, Logistic|The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.||Percentage of participants achieving blood pressure goal of \<130/80 mmHg||||0.0594
72420046|NCT00949884|144351620|SUPERIORITY_OR_OTHER|||||||0.0476||95.0|||||Regression, Logistic|The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.||Percentage of participants achieving blood pressure goal of \<120/80 mmHg||||0.0476
72420047|NCT00949884|144351620|SUPERIORITY_OR_OTHER|||||||0.0657||95.0|||||Regression, Logistic|The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.||Percentage of participants achieving blood pressure goal of \<120/80 mmHg||||0.0657
72420048|NCT00949884|144351621|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.5||||0.325|TWO_SIDED|95.0|-4.4|1.5|||ANCOVA|Treatment is a fixed effect and baseline mean 24-hour ABPM blood pressure as a covariate.||Change from baseline at week 4 in systolic blood pressure.||1.5|-4.4|0.3250
72420049|NCT00949884|144351621|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.4||||0.3491|TWO_SIDED|95.0|-4.4|1.5|||ANCOVA|Treatment is a fixed effect and baseline mean 24-hour ABPM blood pressure as a covariate.||Change from baseline at week 4 in systolic blood pressure.||1.5|-4.4|0.3491
72420050|NCT00949884|144351621|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.2||||0.2085|TWO_SIDED|95.0|-3.2|0.7|||ANCOVA|Treatment is a fixed effect and baseline mean 24-hour ABPM blood pressure is a covariate.||Change from baseline at week 4 in diastolic blood pressure.||0.7|-3.2|0.2085
72420051|NCT00949884|144351621|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.1||||0.2542|TWO_SIDED|95.0|-3.0|0.8|||ANCOVA|Treatment is a fixed effect and baseline mean 24-hour ABPM blood pressure is a covariate.||Change from baseline at week 4 in diastolic blood pressure.||0.8|-3.0|0.2542
72420052|NCT00949884|144351622|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.6||||0.0209|TWO_SIDED|95.0|-6.6|-0.5|||ANCOVA|Treatment is a fixed effect and baseline mean 24-hour ABPM blood pressure is a covariate.||Change from baseline at week 8 in systolic blood pressure.||-0.5|-6.6|0.0209
72420053|NCT00949884|144351622|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.6||||0.0186|TWO_SIDED|95.0|-6.6|-0.6|||ANCOVA|Treatment is a fixed effect and baseline mean 24-hour ABPM blood pressure is a covariate.||Change from baseline at week 8 in systolic blood pressure.||-0.6|-6.6|0.0186
72327576|NCT01682356|144179109|SUPERIORITY|||||||0.0987||||||P values adjusted for multiplicity|ANOVA|Values for blood pressure were analyzed using a repeated measures ANOVA followed by Holm-Šídák multiple comparison testing||||||0.09870
72420054|NCT00949884|144351622|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.5||||0.0175|TWO_SIDED|95.0|-4.5|-0.4|||ANCOVA|Treatment is a fixed effect and baseline mean 24-hour ABPM blood pressure is a covariate.||Change from baseline at week 8 in diastolic blood pressure.||-0.4|-4.5|0.0175
72420055|NCT00949884|144351622|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.4||||0.0177|TWO_SIDED|95.0|-4.4|-0.4|||ANCOVA|Treatment is a fixed effect and baseline mean 24-hour ABPM blood pressure is a covariate.||Change from baseline at week 8 in diastolic blood pressure.||-0.4|-4.4|0.0177
72420056|NCT00949884|144351623|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.8||||0.3104|TWO_SIDED|95.0|-5.2|1.7|||ANCOVA|Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.||Daytime systolic blood pressure||1.7|-5.2|0.3104
72420057|NCT00949884|144351623|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.6||||0.3653|TWO_SIDED|95.0|-4.9|1.8|||ANCOVA|Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.||Daytime systolic blood pressure||1.8|-4.9|0.3653
72614552|NCT04950686|144759122|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.01|STANDARD_ERROR_OF_MEAN|0.04||0.866|TWO_SIDED||||||Mixed Models Analysis|||||||0.866
72614553|NCT04950686|144759122|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.02|STANDARD_ERROR_OF_MEAN|0.06||0.695|TWO_SIDED||||||Mixed Models Analysis|||||||0.695
72420058|NCT00949884|144351623|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.8||||0.1197|TWO_SIDED|95.0|-4.1|0.5|||ANCOVA|Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.||Daytime diastolic blood pressure||0.5|-4.1|0.1197
72420059|NCT00949884|144351623|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.6||||0.1654|TWO_SIDED|95.0|-3.9|0.7|||ANCOVA|Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.||Daytime diastolic blood pressure||0.7|-3.9|0.1654
72327577|NCT01682356|144179110|SUPERIORITY|||||||0.6044||||||P values adjusted for multiplicity|ANOVA|Values for blood pressure were analyzed using a repeated measures ANOVA followed by Holm-Šídák multiple comparison testing||||||0.6044
72420060|NCT00949884|144351623|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.2||||0.4362|TWO_SIDED|95.0|-4.4|1.9|||ANCOVA|Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.||Nighttime systolic blood pressure||1.9|-4.4|0.4362
72420061|NCT00949884|144351623|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.3||||0.4039|TWO_SIDED|95.0|-4.5|1.8|||ANCOVA|Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.||Nighttime systolic blood pressure||1.8|-4.5|0.4039
72420062|NCT00949884|144351623|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9||||0.3929|TWO_SIDED|95.0|-3.1|1.2|||ANCOVA|Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.||Nighttime diastolic blood pressure||1.2|-3.1|0.3929
72420063|NCT00949884|144351623|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9||||0.4259|TWO_SIDED|95.0|-3.0|1.3|||ANCOVA|Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.||Nighttime diastolic blood pressure||1.3|-3.0|0.4259
72420064|NCT00949884|144351624|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.5||||0.0396|TWO_SIDED|95.0|-6.8|-0.2|||ANCOVA|Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.||Daytime systolic blood pressure||-0.2|-6.8|0.0396
72420065|NCT00949884|144351624|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.5||||0.0345|TWO_SIDED|95.0|-6.8|-0.3|||ANCOVA|Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.||Daytime systolic blood pressure||-0.3|-6.8|0.0345
72420066|NCT00949884|144351624|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.5||||0.0324|TWO_SIDED|95.0|-4.8|-0.2|||ANCOVA|Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.||Daytime diastolic blood pressure||-0.2|-4.8|0.0324
72420067|NCT00949884|144351624|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.4||||0.0363|TWO_SIDED|95.0|-4.7|-0.2|||ANCOVA|Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.||Daytime diastolic blood pressure||-0.2|-4.7|0.0363
72420068|NCT00949884|144351624|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.0||||0.0988|TWO_SIDED|95.0|-6.5|0.6|||ANCOVA|Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.||Nighttime systolic blood pressure||0.6|-6.5|0.0988
72420069|NCT00949884|144351624|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.0||||0.0926|TWO_SIDED|95.0|-6.4|0.5|||ANCOVA|Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.||Nighttime systolic blood pressure||0.5|-6.4|0.0926
72420070|NCT00949884|144351624|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.1||||0.09|TWO_SIDED|95.0|-4.5|0.3|||ANCOVA|Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.||Nighttime diastolic blood pressure||0.3|-4.5|0.0900
72420071|NCT00949884|144351624|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.0||||0.0942|TWO_SIDED|95.0|-4.4|0.3|||ANCOVA|Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.||Nighttime diastolic blood pressure||0.3|-4.4|0.0942
72420072|NCT00949884|144351625|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.8||||0.3229|TWO_SIDED|95.0|-5.4|1.8|||ANCOVA|Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.||2 hour systolic blood pressure||1.8|-5.4|0.3229
72420073|NCT00949884|144351625|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.6||||0.3863|TWO_SIDED|95.0|-5.1|2.0|||ANCOVA|Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.||2 hour systolic blood pressure||2.0|-5.1|0.3863
72420074|NCT00949884|144351625|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.0||||0.1277|TWO_SIDED|95.0|-4.5|0.6|||ANCOVA|Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.||2 hour diastolic blood pressure||0.6|-4.5|0.1277
72420075|NCT00949884|144351625|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.7||||0.1799|TWO_SIDED|95.0|-4.3|0.8|||ANCOVA|Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.||2 hour diastolic blood pressure||0.8|-4.3|0.1799
72614554|NCT04950686|144759123|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.004|STANDARD_ERROR_OF_MEAN|0.06||0.94|TWO_SIDED||||||Mixed Models Analysis|||||||0.940
72614555|NCT04950686|144759123|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.05|STANDARD_ERROR_OF_MEAN|0.06||0.451|TWO_SIDED||||||Mixed Models Analysis|||||||0.451
72614556|NCT04950686|144759124|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.04|STANDARD_ERROR_OF_MEAN|0.06||0.442|TWO_SIDED||||||Mixed Models Analysis|||||||0.442
72614557|NCT04950686|144759124|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.11|STANDARD_ERROR_OF_MEAN|0.06||0.082|TWO_SIDED||||||Mixed Models Analysis|||||||0.082
72420076|NCT00949884|144351625|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.8||||0.2708|TWO_SIDED|95.0|-5.1|1.4|||ANCOVA|Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.||4 hour systolic blood pressure||1.4|-5.1|0.2708
72420077|NCT00949884|144351625|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.7||||0.3133|TWO_SIDED|95.0|-5.0|1.6|||ANCOVA|Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.||4 hour systolic blood pressure||1.6|-5.0|0.3133
72420078|NCT00949884|144351625|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.6||||0.1621|TWO_SIDED|95.0|-3.9|0.7|||ANCOVA|Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.||4 hour diastolic blood pressure||0.7|-3.9|0.1621
72420079|NCT00949884|144351625|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.4||||0.2314|TWO_SIDED|95.0|-3.7|0.9|||ANCOVA|Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.||4 hour diastolic blood pressure||0.9|-3.7|0.2314
72420080|NCT00949884|144351625|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.9||||0.2461|TWO_SIDED|95.0|-5.0|1.3|||ANCOVA|Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.||6 hour systolic blood pressure||1.3|-5.0|0.2461
72420081|NCT00949884|144351625|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.8||||0.2558|TWO_SIDED|95.0|-5.0|1.3|||ANCOVA|Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.||6 hour systolic blood pressure||1.3|-5.0|0.2558
72420082|NCT00949884|144351625|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.6||||0.17|TWO_SIDED|95.0|-3.8|0.7|||ANCOVA|Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.||6 hour diastolic blood pressure||0.7|-3.8|0.1700
72420083|NCT00949884|144351625|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.4||||0.2011|TWO_SIDED|95.0|-3.7|0.8|||ANCOVA|Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.||6 hour diastolic blood pressure||0.8|-3.7|0.2011
72420084|NCT00949884|144351626|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.8||||0.1895|TWO_SIDED|95.0|-7.0|1.4|||ANCOVA|Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.||2 hour systolic blood pressure||1.4|-7.0|0.1895
72327578|NCT01682356|144179111|SUPERIORITY|||||||0.6044||||||P values adjusted for multiplicity|ANOVA|Values for blood pressure were analyzed using a repeated measures ANOVA followed by Holm-Šídák multiple comparison testing||||||0.6044
72614558|NCT04950686|144759125|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.07|STANDARD_ERROR_OF_MEAN|0.06||0.236|TWO_SIDED||||||Mixed Models Analysis|||||||0.236
72614559|NCT04950686|144759125|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.03|STANDARD_ERROR_OF_MEAN|0.08||0.674|TWO_SIDED||||||Mixed Models Analysis|||||||0.674
72614560|NCT04950686|144759126|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.11|STANDARD_ERROR_OF_MEAN|0.08||0.135|TWO_SIDED||||||Mixed Models Analysis|||||||0.135
72614561|NCT04950686|144759126|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.05|STANDARD_ERROR_OF_MEAN|0.08||0.5|TWO_SIDED||||||Mixed Models Analysis|||||||0.500
72614562|NCT04950686|144759127|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.005|STANDARD_ERROR_OF_MEAN|0.09||0.956|TWO_SIDED||||||Mixed Models Analysis|||||||0.956
72614563|NCT04950686|144759127|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.11|STANDARD_ERROR_OF_MEAN|0.09||0.214|TWO_SIDED||||||Mixed Models Analysis|||||||0.214
72614564|NCT04950686|144759128|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.06|STANDARD_ERROR_OF_MEAN|0.06||0.337|TWO_SIDED||||||Mixed Models Analysis|||||||0.337
72614565|NCT04950686|144759128|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.004|STANDARD_ERROR_OF_MEAN|0.07||0.957|TWO_SIDED||||||Mixed Models Analysis|||||||0.957
72614566|NCT04950686|144759129|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.14|STANDARD_ERROR_OF_MEAN|0.08||0.086|TWO_SIDED||||||Mixed Models Analysis|||||||0.086
72614567|NCT04950686|144759129|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.05|STANDARD_ERROR_OF_MEAN|0.08||0.515|TWO_SIDED||||||Mixed Models Analysis|||||||0.515
72614568|NCT04950686|144759130|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.04|STANDARD_ERROR_OF_MEAN|0.08||0.597|TWO_SIDED||||||Mixed Models Analysis|||||||0.597
72614569|NCT04950686|144759130|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.05|STANDARD_ERROR_OF_MEAN|0.09||0.551|TWO_SIDED||||||Mixed Models Analysis|||||||0.551
72614570|NCT04950686|144759131|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.02|STANDARD_ERROR_OF_MEAN|0.04||0.634|TWO_SIDED||||||Mixed Models Analysis|||||||0.634
72614571|NCT04950686|144759131|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.05|STANDARD_ERROR_OF_MEAN|0.05||0.308|TWO_SIDED||||||Mixed Models Analysis|||||||0.308
72614572|NCT04950686|144759132|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.05|STANDARD_ERROR_OF_MEAN|0.06||0.415|TWO_SIDED||||||Mixed Models Analysis|||||||0.415
72614573|NCT04950686|144759132|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.02|STANDARD_ERROR_OF_MEAN|0.06||0.721|TWO_SIDED||||||Mixed Models Analysis|||||||0.721
72614574|NCT04950686|144759133|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.07|STANDARD_ERROR_OF_MEAN|0.06||0.261|TWO_SIDED||||||Mixed Models Analysis|||||||0.261
72614575|NCT04950686|144759133|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.06|STANDARD_ERROR_OF_MEAN|0.06||0.369|TWO_SIDED||||||Mixed Models Analysis|||||||0.369
72327579|NCT01682356|144179112|SUPERIORITY|||||||0.8819||||||P values adjusted for multiplicity|ANOVA|Values for blood pressure were analyzed using a repeated measures ANOVA followed by Holm-Šídák multiple comparison testing||||||0.8819
72614576|NCT04950686|144759134|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.09|STANDARD_ERROR_OF_MEAN|0.06||0.124|TWO_SIDED||||||Mixed Models Analysis|||||||0.124
72614577|NCT04950686|144759134|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.02|STANDARD_ERROR_OF_MEAN|0.06||0.794|TWO_SIDED||||||Mixed Models Analysis|||||||0.794
72327580|NCT01682356|144179113|SUPERIORITY|||||||0.8987||||||P values adjusted for multiplicity|ANOVA|Values for blood pressure were analyzed using a repeated measures ANOVA followed by Holm-Šídák multiple comparison testing||||||0.8987
72614578|NCT04950686|144759135|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.17|STANDARD_ERROR_OF_MEAN|0.07||0.011|TWO_SIDED||||||Mixed Models Analysis|||||||0.011
72327581|NCT02413996|144179158|SUPERIORITY||Mean Difference (Net)|5.94|STANDARD_DEVIATION|5.3||0.05|TWO_SIDED|95.0|-4.62|16.51|||t-test, 2 sided|||Does VRRS rehabilitation is superior to the traditional one?||16.51|-4.62|0.05
72327582|NCT03810014|144179167|SUPERIORITY||Risk Difference (RD)|2.5||||0.01|TWO_SIDED|98.0|0.2|4.8|||Generalized estimating equations|||(Arm 3 + Arm 4) vs (Arm 1 + Arm 2)||4.80|0.20|0.01
72327583|NCT03810014|144179167|SUPERIORITY||Risk Ratio, log|1.025||||0.012|TWO_SIDED|98.0|1.002|1.049|||Generalized estimating equations|||(Arm 3 + Arm 4) vs (Arm 1 + Arm 2)||1.049|1.002|0.012
72420085|NCT00949884|144351626|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.3||||0.2701|TWO_SIDED|95.0|-6.5|1.8|||ANCOVA|Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.||2 hour systolic blood pressure||1.8|-6.5|0.2701
72614579|NCT04950686|144759135|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.13|STANDARD_ERROR_OF_MEAN|0.07||0.068|TWO_SIDED||||||Mixed Models Analysis|||||||0.068
72614580|NCT04950686|144759136|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.04|STANDARD_ERROR_OF_MEAN|0.08||0.585|TWO_SIDED||||||Mixed Models Analysis|||||||0.585
72614581|NCT04950686|144759136|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.07|STANDARD_ERROR_OF_MEAN|0.08||0.338|TWO_SIDED||||||Mixed Models Analysis|||||||0.338
72614582|NCT04950686|144759137|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.05|STANDARD_ERROR_OF_MEAN|0.04||0.259|TWO_SIDED||||||Mixed Models Analysis|||||||0.259
72614583|NCT04950686|144759137|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.003|STANDARD_ERROR_OF_MEAN|0.05||0.95|TWO_SIDED||||||Mixed Models Analysis|||||||0.950
72614584|NCT04950686|144759138|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.04|STANDARD_ERROR_OF_MEAN|0.05||0.411|TWO_SIDED||||||Mixed Models Analysis|||||||0.411
72614585|NCT04950686|144759138|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.03|STANDARD_ERROR_OF_MEAN|0.05||0.491|TWO_SIDED||||||Mixed Models Analysis|||||||0.491
72327584|NCT03810014|144179167|SUPERIORITY||Risk Difference (RD)|-0.6||||0.33|TWO_SIDED|98.0|-2.2|0.9|||Generalized estimating equations|||(Arm 1 + Arm 3) vs (Arm 2 + Arm 4)||0.90|-2.20|0.33
72327585|NCT03810014|144179167|SUPERIORITY||Risk Ratio, log|0.994||||0.332|TWO_SIDED|98.0|0.979|1.009|||Generalized estimating equations|||(Arm 1 + Arm 3) vs (Arm 2 + Arm 4)||1.009|0.979|0.332
72327586|NCT03502915|144179220|EQUIVALENCE|The equivalence margin is the standard error of the estimated difference.|Mean Difference (Final Values)|0.053|STANDARD_DEVIATION|2.508||0.943|TWO_SIDED|95.0|-1.402|1.507|||t-test, 2 sided|||||1.507|-1.402|0.943
72420086|NCT00949884|144351626|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.3||||0.1328|TWO_SIDED|95.0|-5.2|0.7|||ANCOVA|Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.||2 hour diastolic blood pressure||0.7|-5.2|0.1328
72420087|NCT00949884|144351626|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.0||||0.1778|TWO_SIDED|95.0|-4.9|0.9|||ANCOVA|Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.||2 hour diastolic blood pressure||0.9|-4.9|0.1778
72420088|NCT00949884|144351626|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.6||||0.062|TWO_SIDED|95.0|-7.3|0.2|||ANCOVA|Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.||4 hour systolic blood pressure||0.2|-7.3|0.0620
72614586|NCT04950686|144759139|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.03|STANDARD_ERROR_OF_MEAN|0.05||0.498|TWO_SIDED||||||Mixed Models Analysis|||||||0.498
72614587|NCT04950686|144759139|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.03|STANDARD_ERROR_OF_MEAN|0.05||0.573|TWO_SIDED||||||Mixed Models Analysis|||||||0.573
72327587|NCT03502915|144179221|EQUIVALENCE|The equivalence margin is the standard error of the estimated difference.|Mean Difference (Final Values)|0.443|STANDARD_DEVIATION|2.867||0.597|TWO_SIDED|95.0|-1.229|2.114|||t-test, 2 sided|||||2.114|-1.229|0.597
72327588|NCT03502915|144179222|EQUIVALENCE|The equivalence margin is the standard error of the estimated difference.|Mean Difference (Final Values)|0.12|STANDARD_DEVIATION|1.28||0.748|TWO_SIDED|95.0|-0.629|0.869|||t-test, 2 sided|||||0.869|-0.629|0.748
72420089|NCT00949884|144351626|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.1||||0.1011|TWO_SIDED|95.0|-6.9|0.6|||ANCOVA|Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.||4 hour systolic blood pressure||0.6|-6.9|0.1011
72420090|NCT00949884|144351626|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.0||||0.0249|TWO_SIDED|95.0|-5.6|-0.4|||ANCOVA|Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.||4 hour diastolic blood pressure||-0.4|-5.6|0.0249
72614588|NCT04950686|144759140|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.09|STANDARD_ERROR_OF_MEAN|0.06||0.128|TWO_SIDED||||||Mixed Models Analysis|||||||0.128
72614589|NCT04950686|144759140|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.21|STANDARD_ERROR_OF_MEAN|0.08||0.013|TWO_SIDED||||||Mixed Models Analysis|||||||0.013
72614590|NCT04950686|144759141|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.0001|STANDARD_ERROR_OF_MEAN|0.07||0.999|TWO_SIDED||||||Mixed Models Analysis|||||||0.999
72614591|NCT04950686|144759141|EQUIVALENCE|This arm will receive Health Aware for Young Adults in between the pretest and posttest questionnaire. Health Aware for Young Adults is a web-based sexual and relationship health promotion program. The program contains the same health content as Media Aware for Young Adults but without the media literacy education components. The program is self-paced and includes four modules.|Mean Difference (Net)|0.04|STANDARD_ERROR_OF_MEAN|0.08||0.638|TWO_SIDED||||||Mixed Models Analysis|||||||0.638
72614592|NCT04950686|144759142|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.01|STANDARD_ERROR_OF_MEAN|0.07||0.841|TWO_SIDED||||||Mixed Models Analysis|||||||0.841
72614593|NCT04950686|144759142|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.08|STANDARD_ERROR_OF_MEAN|0.08||0.27|TWO_SIDED||||||Mixed Models Analysis|||||||0.270
72327589|NCT03502915|144179223|EQUIVALENCE|The equivalence margin is the standard error of the estimated difference.|Mean Difference (Final Values)|-2.634|STANDARD_DEVIATION|3.816||0.025|TWO_SIDED|95.0|-4.927|-0.341|||t-test, 2 sided|||||-0.341|-4.927|0.025
72420091|NCT00949884|144351626|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.6||||0.0497|TWO_SIDED|95.0|-5.2|0.0|||ANCOVA|Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.||4 hour diastolic blood pressure||0.0|-5.2|0.0497
72420092|NCT00949884|144351626|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.5||||0.0552|TWO_SIDED|95.0|-7.1|0.1|||ANCOVA|Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.||6 hour systolic blood pressure||0.1|-7.1|0.0552
72420093|NCT00949884|144351626|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.2||||0.0767|TWO_SIDED|95.0|-6.8|0.3|||ANCOVA|Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.||6 hour systolic blood pressure||0.3|-6.8|0.0767
72420094|NCT00949884|144351626|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.8||||0.0279|TWO_SIDED|95.0|-5.3|-0.3|||ANCOVA|Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.||6 hour diastolic blood pressure||-0.3|-5.3|0.0279
72420095|NCT00949884|144351626|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.5||||0.0434|TWO_SIDED|95.0|-5.0|-0.1|||ANCOVA|Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.||6 hour diastolic blood pressure||-0.1|-5.0|0.0434
72420096|NCT00949884|144351627|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.3||||0.0009|TWO_SIDED|95.0|-6.8|-1.8|||ANCOVA|Treatment is a fixed effect and baseline blood pressure is a covariate.||Diastolic blood pressure||-1.8|-6.8|0.0009
72420097|NCT00949884|144351627|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.6|||<|0.0001|TWO_SIDED|95.0|-12.5|-4.7|||ANCOVA|Treatment is a fixed effect and baseline blood pressure is a covariate.||Systolic blood pressure||-4.7|-12.5|<0.0001
72420098|NCT03092375|144351631|OTHER|Study is not intended to be powered|Mean Difference (Final Values)|-0.76|||||TWO_SIDED|95.0|-9.48|5.12|||||Excludes re-infection and death|The difference in the percentage of subjects with on-treatment virologic failure (Defined as increase of \>1 log10 IU/mL above nadir during treatment, or HCV RNA \>= 15 IU/mL at end of treatment with at least 6 weeks of treatment between Arms A and B are summarized with two-sided 95% Wilson score intervals.||5.12|-9.48|
72420099|NCT03092375|144351632|OTHER|The difference in the percentage of subjects with post-treatment relapse between Arms A and B are summarized with two-sided 95% Wilson score intervals.|Mean Difference (Final Values)|-2.5|||||TWO_SIDED|95.0|-10.49|5.49||||||||5.49|-10.49|
72420100|NCT03092375|144351633|OTHER|Difference in percentage of subjects with on-treatment virologic failure between Arms C and D will be summarized with two-sided 95% Wilson score intervals|Mean Difference (Final Values)|9.52|||||TWO_SIDED|95.0|-3.03|22.08||||||||22.08|-3.03|
72614594|NCT04950686|144759143|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.01|STANDARD_ERROR_OF_MEAN|0.08||0.94|TWO_SIDED||||||Mixed Models Analysis|||||||0.940
72614595|NCT04950686|144759143|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.001|STANDARD_ERROR_OF_MEAN|0.09||0.992|TWO_SIDED||||||Mixed Models Analysis|||||||0.992
72327590|NCT03502915|144179224|EQUIVALENCE|The equivalence margin is the standard error of the estimated difference.|Mean Difference (Final Values)|0.056|STANDARD_DEVIATION|2.742||0.944|TWO_SIDED|95.0|-1.543|1.655|||t-test, 2 sided|||||1.655|-1.543|0.944
72420101|NCT03092375|144351634|OTHER||Mean Difference (Final Values)|-1.81|||||TWO_SIDED|95.0|-13.85|10.22||||||Excludes re-infection and death||10.22|-13.85|
72420102|NCT03092375|144351635|OTHER|Study was not powered to compare efficacy|Logistic Regression Contrast Estimate|-0.812||||0.161|TWO_SIDED|95.0|-1.947|0.323|||Chi-squared|Logistic regression contrast estimates with Wald confidence intervals and Chi-square p values|Comparison of Arm Pair A/C versus B/D overall on mITT population|||0.323|-1.947|0.161
72420103|NCT03092375|144351635|OTHER|Study is not powered to compare efficacy of 12 wks vs 16 weeks of treatment|Logistic regression contrast estimate|0.89||||0.89|TWO_SIDED|95.0|-1.239|1.076|||Chi-squared|Logistic regression contrast estimates with Wald confidence intervals and Chi-square p values|Difference in proportion of SVR12 rates for 12 vs 16 weeks on mITT Comparing Cirrhotic subjects versus non-cirrhotic subjects.|||1.076|-1.239|0.890
72420104|NCT03092375|144351635|OTHER|Study is not powered|Logistic regression contrast estimate|0.977||||0.265|TWO_SIDED|95.0|-0.74|2.694|||Chi-squared|||Comparison of 12 weeks vs 16 weeks in Genotype 1b vs non-1b||2.694|-0.740|0.265
72420105|NCT01255592|144351636|SUPERIORITY_OR_OTHER||Ratio of AZD5069 80 mg to placebo|0.31||||0.004|TWO_SIDED|90.0|0.17|0.59|||ANCOVA|||Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection, and baseline as covariates. The analysis was done on log-transformed data. The results were back-transformed after the analysis on the log scale.||0.59|0.17|0.004
72614596|NCT04950686|144759144|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.04|STANDARD_ERROR_OF_MEAN|0.06||0.47|TWO_SIDED||||||Mixed Models Analysis|||||||0.470
72614597|NCT04950686|144759144|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.09|STANDARD_ERROR_OF_MEAN|0.06||0.13|TWO_SIDED||||||Mixed Models Analysis|||||||0.130
72420106|NCT01255592|144351637|SUPERIORITY_OR_OTHER||Ratio of AZD5069 80 mg to placebo|0.64||||0.008|TWO_SIDED|90.0|0.49|0.84|||ANCOVA|||Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection, and baseline as covariates. The analysis was done on log-transformed data. The results were back-transformed after the analysis on the log scale.||0.84|0.49|0.008
72420107|NCT01255592|144351638|SUPERIORITY_OR_OTHER||LS mean difference|6.78|STANDARD_ERROR_OF_MEAN|3.298||0.047|TWO_SIDED|90.0|1.22|12.33|||ANCOVA|||The 24-hour sputum weight on Visit 4 was compared between groups using ANCOVA (additive model) with treatment and inhaled corticosteroids/P. aeruginosa infection as fixed effects and baseline as a covariate.||12.33|1.22|0.047
72420108|NCT01255592|144351639|SUPERIORITY_OR_OTHER||LS mean difference|0.1|STANDARD_ERROR_OF_MEAN|0.092||0.284|TWO_SIDED|90.0|-0.05|0.26|||ANCOVA|||Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.||0.26|-0.05|0.284
72420109|NCT01255592|144351640|SUPERIORITY_OR_OTHER||LS mean difference|0.01|STANDARD_ERROR_OF_MEAN|0.078||0.929|TWO_SIDED|90.0|-0.12|0.14|||ANCOVA|||Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.||0.14|-0.12|0.929
72420110|NCT01255592|144351641|SUPERIORITY_OR_OTHER||LS mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.062||0.966|TWO_SIDED|90.0|-0.11|0.1|||ANCOVA|||Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.||0.10|-0.11|0.966
72614598|NCT04950686|144759145|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.01|STANDARD_ERROR_OF_MEAN|0.07||0.931|TWO_SIDED||||||Mixed Models Analysis|||||||0.931
72420111|NCT01255592|144351642|SUPERIORITY_OR_OTHER||LS mean difference|0.02|STANDARD_ERROR_OF_MEAN|0.09||0.791|TWO_SIDED|90.0|-0.13|0.17|||ANCOVA|||Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.||0.17|-0.13|0.791
72614599|NCT04950686|144759145|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.03|STANDARD_ERROR_OF_MEAN|0.07||0.666|TWO_SIDED||||||Mixed Models Analysis|||||||0.666
72614600|NCT04950686|144759146|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.02|STANDARD_ERROR_OF_MEAN|0.07||0.822|TWO_SIDED||||||Mixed Models Analysis|||||||0.822
72614601|NCT04950686|144759146|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.03|STANDARD_ERROR_OF_MEAN|0.07||0.721|TWO_SIDED||||||Mixed Models Analysis|||||||0.721
72614602|NCT04950686|144759147|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.03|STANDARD_ERROR_OF_MEAN|0.05||0.54|TWO_SIDED||||||Mixed Models Analysis|||||||0.540
72614603|NCT04950686|144759147|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.003|STANDARD_ERROR_OF_MEAN|0.06||0.956|TWO_SIDED||||||Mixed Models Analysis|||||||0.956
72614604|NCT04950686|144759148|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.09|STANDARD_ERROR_OF_MEAN|0.06||0.175|TWO_SIDED||||||Mixed Models Analysis|||||||0.175
72614605|NCT04950686|144759148|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.09|STANDARD_ERROR_OF_MEAN|0.06||0.136|TWO_SIDED||||||Mixed Models Analysis|||||||0.136
72327591|NCT01107964|144179246|SUPERIORITY|||||||0.61|||||||Wilcoxon (Mann-Whitney)|||||||0.61
72614606|NCT04950686|144759149|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.01|STANDARD_ERROR_OF_MEAN|0.06||0.829|TWO_SIDED||||||Mixed Models Analysis|||||||0.829
72614607|NCT04950686|144759149|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.02|STANDARD_ERROR_OF_MEAN|0.07||0.748|TWO_SIDED||||||Mixed Models Analysis|||||||0.748
72614608|NCT04950686|144759150|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.08|STANDARD_ERROR_OF_MEAN|0.12||0.49|TWO_SIDED||||||Mixed Models Analysis|||||||0.490
72614609|NCT04950686|144759150|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.03|STANDARD_ERROR_OF_MEAN|0.13||0.831|TWO_SIDED||||||Mixed Models Analysis|||||||0.831
72420112|NCT01255592|144351643|SUPERIORITY_OR_OTHER||LS mean difference|-1.0|STANDARD_ERROR_OF_MEAN|0.7||0.433|TWO_SIDED|90.0|-1.6|0.6|||ANCOVA|||The ANCOVA model used TDI as the response variable with treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and BDI as covariates.||0.6|-1.6|0.433
72327592|NCT01107964|144179247|SUPERIORITY|||||||0.57|||||||Wilcoxon (Mann-Whitney)|||||||0.57
72327593|NCT01107964|144179248|SUPERIORITY|||||||0.44|||||||Wilcoxon (Mann-Whitney)|||||||0.44
72420113|NCT01255592|144351644|SUPERIORITY_OR_OTHER||LS mean difference|0.7|STANDARD_ERROR_OF_MEAN|8.03||0.935|TWO_SIDED|90.0|-12.81|14.13|||ANCOVA|||Morning PEF: Analysis of covariance includes treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.||14.13|-12.81|0.935
72420114|NCT01255592|144351644|SUPERIORITY_OR_OTHER||LS mean difference|3.3|STANDARD_ERROR_OF_MEAN|7.35||0.654|TWO_SIDED|90.0|-9.02|15.64|||ANCOVA|||Evening PEF: Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.||15.64|-9.02|0.654
72420115|NCT01255592|144351645|SUPERIORITY_OR_OTHER||LS mean difference|0.1|STANDARD_ERROR_OF_MEAN|0.14||0.329|TWO_SIDED|90.0|-0.09|0.36|||ANCOVA|||Describe your breathing: Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.||0.36|-0.09|0.329
72420116|NCT01255592|144351645|SUPERIORITY_OR_OTHER||LS mean difference|0.1|STANDARD_ERROR_OF_MEAN|0.13||0.664|TWO_SIDED|90.0|-0.16|0.27|||ANCOVA|||How often do you cough?: Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.||0.27|-0.16|0.664
72420117|NCT01255592|144351645|SUPERIORITY_OR_OTHER||LS mean difference|0.3|STANDARD_ERROR_OF_MEAN|0.17||0.152|TWO_SIDED|90.0|-0.04|0.54|||ANCOVA|||Night time symptom score: Analysis of covariance includes treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.||0.54|-0.04|0.152
72420118|NCT01255592|144351645|SUPERIORITY_OR_OTHER||LS mean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.25||0.15|TWO_SIDED|90.0|-0.8|0.05|||ANCOVA|||What color is your sputum?: Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.||0.05|-0.80|0.150
72614610|NCT04950686|144759151|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.09|STANDARD_ERROR_OF_MEAN|0.1||0.35|TWO_SIDED||||||Mixed Models Analysis|||||||0.350
72614611|NCT04950686|144759151|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.12|STANDARD_ERROR_OF_MEAN|0.1||0.235|TWO_SIDED||||||Mixed Models Analysis|||||||0.235
72614612|NCT04950686|144759152|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.04|STANDARD_ERROR_OF_MEAN|0.1||0.682|TWO_SIDED||||||Mixed Models Analysis|||||||0.682
72614613|NCT04950686|144759152|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.1|STANDARD_ERROR_OF_MEAN|0.11||0.373|TWO_SIDED||||||Mixed Models Analysis|||||||0.373
72614614|NCT04950686|144759153|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Odds Ratio (OR)|1.25||||0.242|TWO_SIDED|95.0|0.24|6.63|||Mixed Models Analysis|||||6.63|0.24|0.242
72614615|NCT04950686|144759153|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Odds Ratio (OR)|0.78||||0.207|TWO_SIDED|95.0|0.11|5.72|||Mixed Models Analysis|||||5.72|0.11|0.207
72614616|NCT04950686|144759154|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Odds Ratio (OR)|0.88||||0.576|TWO_SIDED|95.0|0.51|1.52|||Mixed Models Analysis|||||1.52|0.51|0.576
72327594|NCT01107964|144179249|SUPERIORITY|||||||0.48|||||||Wilcoxon (Mann-Whitney)|||||||0.48
72327595|NCT02148263|144179281|SUPERIORITY|||||||0.83|||||||Wilcoxon (Mann-Whitney)|||||||0.83
72327596|NCT02148263|144179282|SUPERIORITY|||||||0.95|||||||Wilcoxon (Mann-Whitney)|||||||0.95
72420119|NCT01255592|144351645|SUPERIORITY_OR_OTHER||LS mean difference|0.1|STANDARD_ERROR_OF_MEAN|0.12||0.248|TWO_SIDED|90.0|-0.06|0.35|||ANCOVA|||The amount of sputum you produced: Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.||0.35|-0.06|0.248
72420120|NCT01255592|144351645|SUPERIORITY_OR_OTHER||LS mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.12||0.053|TWO_SIDED|90.0|-0.45|-0.04|||ANCOVA|||Type of sputum: Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.||-0.04|-0.45|0.053
72327597|NCT02148263|144179283|SUPERIORITY|||||||0.94|||||||Wilcoxon (Mann-Whitney)|||||||.94
72327598|NCT02148263|144179284|SUPERIORITY|||||||0.96|||||||Wilcoxon (Mann-Whitney)|||||||.96
72327599|NCT02148263|144179285|SUPERIORITY|||||||0.14|||||||Wilcoxon (Mann-Whitney)|||||||.14
72327600|NCT02148263|144179286|SUPERIORITY|This is for the upper eyelid evaluation.||||||0.27|||||||Fisher Exact|||||||.27
72327601|NCT02148263|144179286|SUPERIORITY|||||||0.58|||||||Fisher Exact|||This is for the lower eyelid evaluation.||||.58
72420121|NCT01255592|144351645|SUPERIORITY_OR_OTHER||LS mean difference|0.2|STANDARD_ERROR_OF_MEAN|0.14||0.179|TWO_SIDED|90.0|-0.04|0.42|||ANCOVA|||How do you feel?: Analysis of covariance includes treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.||0.42|-0.04|0.179
72420122|NCT01255592|144351645|SUPERIORITY_OR_OTHER||LS mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.43||0.942|TWO_SIDED|90.0|-0.75|0.68|||ANCOVA|||Number of puffs of inhalers: Analysis of covariance includes treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.||0.68|-0.75|0.942
72327602|NCT02148263|144179287|SUPERIORITY|||||||0.5|||||||Fisher Exact|||Extent||||.50
72327603|NCT02148263|144179287|SUPERIORITY|||||||0.76|||||||Fisher Exact|||Type||||.76
72327604|NCT02148263|144179287|SUPERIORITY|||||||0.5|||||||Fisher Exact|||Depth||||.50
72327605|NCT02148263|144179288|SUPERIORITY|||||||0.32|||||||Wilcoxon (Mann-Whitney)|||||||0.32
72327606|NCT02148263|144179289|SUPERIORITY|||||||0.47|||||||Wilcoxon (Mann-Whitney)|||||||0.47
72327607|NCT00906178|144179302|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.05|||||TWO_SIDED|95.0|0.57|1.94||||||||1.94|.57|
72327608|NCT00906178|144179303|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.01|||||TWO_SIDED|95.0|0.62|1.65||||||||1.65|.62|
72327609|NCT00906178|144179304|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.56|||||TWO_SIDED|95.0|0.93|2.62||||||||2.62|.93|
72327610|NCT00906178|144179305|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.7|||||TWO_SIDED|95.0|0.37|1.3||||||||1.30|.37|
72420123|NCT01255592|144351646|SUPERIORITY_OR_OTHER||LS mean difference|-1.66|STANDARD_ERROR_OF_MEAN|3.374||0.625|TWO_SIDED|90.0|-7.32|4.0|||ANCOVA|||Total score: Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.||4.00|-7.32|0.625
72327611|NCT00778336|144179328|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|Alternative hypothesis is change in occlusion \> 0.||||||<0.0001
72327612|NCT00778336|144179328|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|Alternative hypothesis is change in occlusion \> 0.||||||<0.0001
72327613|NCT00778336|144179328|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|Alternative hypothesis is change in occlusion \> 0.||||||<0.0001
72420124|NCT01255592|144351646|SUPERIORITY_OR_OTHER||LS mean difference|-4.88|STANDARD_ERROR_OF_MEAN|3.342||0.151|TWO_SIDED|90.0|-10.49|0.74|||ANCOVA|||Symptom domain: Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.||0.74|-10.49|0.151
72327614|NCT00778336|144179328|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|Alternative hypothesis is change in occlusion \> 0.||||||<0.0001
72327615|NCT00873821|144179333|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|40.83|||<|0.001|TWO_SIDED|95.0|26.33|55.32|||Mixed Models Analysis|||Difference (placebo minus MK-0941) in change from baseline to Day 13||55.32|26.33|<0.001
72327616|NCT02012218|144179343|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values were calculated according to testing a null hypothesis of zero mean change.|Mixed Models Analysis|This analysis was conducted using a mixed model repeated measures analysis on observed case data.||The null hypothesis of zero in mean change from baseline in MADRS total score at Week 6 was tested for each treatment group at significance level of 0.05 (2-sided).||||<0.0001
72327617|NCT01166347|144179396|NON_INFERIORITY|The non-inferiority margin was 15%.|Difference in Percentages|3.7||||0.011|ONE_SIDED|95.0||12.56|||Wald test||Difference = Control - HeartWare|Primary endpoint is 2 year survival free from disabling stroke (Modified Rankin Scale \>=4), death, exchange, explant due to device malfunction or urgent transplantation. Subjects who are electively transplanted or explanted due to recovery (no disabling stroke) must survive to 2 years post original implant to be considered a success.||12.56||0.0110
72327618|NCT01166347|144179397|SUPERIORITY||Difference in Percentages|1.1||||0.5922|TWO_SIDED|95.0|-8.5|10.8||If p\<0.05, then the test is statistically significant.|Regression, Logistic|Treatment as the only independent variable.|Difference = HeartWare - Control|If non-inferiority is established for the primary endpoint, statistical testing for superiority and p-value estimation for the 3 secondary endpoints (incidence of bleeding, incidence of major infection, overall survival) will be performed in a pre-specified sequence and testing will continue at the nominal alpha level until the first non-significant result. This fixed sequence procedure strongly controls the family-wise error rate for the collection of the 3 secondary endpoints.||10.8|-8.5|0.5922
72327619|NCT02891226|144179416|SUPERIORITY||Odds Ratio (OR)|2.75||||0.079|TWO_SIDED|90.0|1.07|7.08|||Regression, Logistic|||||7.08|1.07|0.079
72327620|NCT02891226|144179416|SUPERIORITY||Odds Ratio (OR)|4.92||||0.003|TWO_SIDED|90.0|2.01|12.07|||Regression, Logistic|||||12.07|2.01|0.003
72327621|NCT02891226|144179416|SUPERIORITY||Odds Ratio (OR)|6.14|||<|0.001|TWO_SIDED|90.0|2.81|13.42|||Regression, Logistic|||||13.42|2.81|<0.001
72327622|NCT02891226|144179417|SUPERIORITY||Odds Ratio (OR)|4.31||||0.241|TWO_SIDED|90.0|0.55|33.58|||Regression, Logistic|||||33.58|0.55|0.241
72327623|NCT02891226|144179417|SUPERIORITY||Odds Ratio (OR)|11.16||||0.032|TWO_SIDED|90.0|1.76|70.64|||Regression, Logistic|||||70.64|1.76|0.032
72420125|NCT01255592|144351646|SUPERIORITY_OR_OTHER||LS mean difference|-1.31|STANDARD_ERROR_OF_MEAN|4.524||0.773|TWO_SIDED|90.0|-8.91|6.28|||ANCOVA|||Activity domain: Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.||6.28|-8.91|0.773
72327624|NCT02891226|144179417|SUPERIORITY||Odds Ratio (OR)|16.04||||0.009|TWO_SIDED|90.0|2.82|91.32|||Regression, Logistic|||||91.32|2.82|0.009
72327625|NCT02891226|144179418|SUPERIORITY||Odds Ratio (OR)|2.0||||0.33|TWO_SIDED|90.0|0.62|6.45|||Regression, Logistic|||||6.45|0.62|0.330
72327626|NCT02891226|144179418|SUPERIORITY||Odds Ratio (OR)|5.72||||0.006|TWO_SIDED|90.0|2.02|16.21|||Regression, Logistic|||||16.21|2.02|0.006
72327627|NCT02891226|144179418|SUPERIORITY||Odds Ratio (OR)|3.52||||0.029|TWO_SIDED|90.0|1.37|9.07|||Regression, Logistic|||||9.07|1.37|0.029
72327628|NCT02891226|144179419|SUPERIORITY||LS Mean difference (Final Values)|-0.64|STANDARD_ERROR_OF_MEAN|0.234||0.007|TWO_SIDED|90.0|-1.03|-0.25|||Mixed Models Analysis|||||-0.25|-1.03|0.007
72327629|NCT02891226|144179419|SUPERIORITY||LS Mean difference (Final Values)|-0.83|STANDARD_ERROR_OF_MEAN|0.23|<|0.001|TWO_SIDED|90.0|-1.21|-0.45|||Mixed Models Analysis|||||-0.45|-1.21|<0.001
72327630|NCT02891226|144179419|SUPERIORITY||LS Mean difference (Final Values)|-0.53|STANDARD_ERROR_OF_MEAN|0.188||0.005|TWO_SIDED|90.0|-0.84|-0.22|||Mixed Models Analysis|||||-0.22|-0.84|0.005
72327631|NCT02891226|144179421|SUPERIORITY||LS Mean difference (Final Values)|24.05|STANDARD_ERROR_OF_MEAN|6.358|<|0.001|TWO_SIDED|90.0|13.53|34.56|||Mixed Models Analysis|||||34.56|13.53|<0.001
72327632|NCT02891226|144179421|SUPERIORITY||LS Mean difference (Final Values)|29.46|STANDARD_ERROR_OF_MEAN|6.421|<|0.001|TWO_SIDED|90.0|18.84|40.08|||Mixed Models Analysis|||||40.08|18.84|<0.001
72327633|NCT02891226|144179421|SUPERIORITY||LS Mean difference (Final Values)|25.24|STANDARD_ERROR_OF_MEAN|5.185|<|0.001|TWO_SIDED|90.0|16.67|33.82|||Mixed Models Analysis|||||33.82|16.67|<0.001
72327634|NCT02891226|144179422|SUPERIORITY||LS Mean difference (Final Values)|7.91|STANDARD_ERROR_OF_MEAN|2.072|<|0.001|TWO_SIDED|90.0|4.48|11.34|||Mixed Models Analysis|||||11.34|4.48|<0.001
72327635|NCT02891226|144179422|SUPERIORITY||LS Mean difference (Final Values)|6.2|STANDARD_ERROR_OF_MEAN|2.102||0.004|TWO_SIDED|90.0|2.72|9.67|||Mixed Models Analysis|||||9.67|2.72|0.004
72327636|NCT02891226|144179422|SUPERIORITY||LS Mean difference (Final Values)|6.73|STANDARD_ERROR_OF_MEAN|1.686|<|0.001|TWO_SIDED|90.0|3.94|9.51|||Mixed Models Analysis|||||9.51|3.94|<0.001
72327637|NCT02891226|144179423|SUPERIORITY||LS Mean difference (Final Values)|5.14|STANDARD_ERROR_OF_MEAN|1.927||0.008|TWO_SIDED|90.0|1.95|8.32|||Mixed Models Analysis|||Mental Component Summary (MCS)||8.32|1.95|0.008
72327638|NCT02891226|144179423|SUPERIORITY||LS Mean difference (Final Values)|4.18|STANDARD_ERROR_OF_MEAN|1.951||0.033|TWO_SIDED|90.0|0.96|7.41|||Mixed Models Analysis|||Mental Component Summary (MCS)||7.41|0.96|0.033
72327639|NCT02891226|144179423|SUPERIORITY||LS Mean difference (Final Values)|3.71|STANDARD_ERROR_OF_MEAN|1.589||0.021|TWO_SIDED|90.0|1.08|6.34|||Mixed Models Analysis|||Mental Component Summary (MCS)||6.34|1.08|0.021
72327640|NCT02891226|144179423|SUPERIORITY||LS Mean difference (Final Values)|1.59|STANDARD_ERROR_OF_MEAN|1.319||0.229|TWO_SIDED|90.0|-0.59|3.77|||Mixed Models Analysis|||Physical Component Summary (PCS)||3.77|-0.59|0.229
72327641|NCT02891226|144179423|SUPERIORITY||LS Mean difference (Final Values)|4.91|STANDARD_ERROR_OF_MEAN|1.349|<|0.001|TWO_SIDED|90.0|2.67|7.14|||Mixed Models Analysis|||Physical Component Summary (PCS)||7.14|2.67|<0.001
72327642|NCT02891226|144179423|SUPERIORITY||LS Mean difference (Final Values)|3.6|STANDARD_ERROR_OF_MEAN|1.078||0.001|TWO_SIDED|90.0|1.81|5.38|||Mixed Models Analysis|||Physical Component Summary (PCS)||5.38|1.81|0.001
72614617|NCT04950686|144759154|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Odds Ratio (OR)|0.97||||0.888|TWO_SIDED|95.0|0.46|2.03|||Mixed Models Analysis|||||2.03|0.46|0.888
72327643|NCT00145626|144179433|SUPERIORITY_OR_OTHER||Cumulative Incidence|0.214|STANDARD_ERROR_OF_MEAN|0.114|||TWO_SIDED||||||||The cumulative incidence estimate and its standard error for occurrence of regimen-related mortality by the end of the first 100 days post-transplant was calculated.|||||
72327644|NCT01102491|144179506|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||t-test, 2 sided|||||||<0.05
72420126|NCT01255592|144351646|SUPERIORITY_OR_OTHER||LS mean difference|-0.39|STANDARD_ERROR_OF_MEAN|3.845||0.92|TWO_SIDED|90.0|-6.84|6.07|||ANCOVA|||Impact domain: Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.||6.07|-6.84|0.920
72327645|NCT03533660|144179525|SUPERIORITY||||||<|0.05||||||Applies to SOCRATES subscales recognition, ambivalence, taking steps at 6 weeks|t-test, 2 sided|||||||<.05
72614618|NCT04950686|144759155|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Odds Ratio (OR)|0.87||||0.467|TWO_SIDED|95.0|0.22|3.45|||Mixed Models Analysis|||||3.45|0.22|0.467
72327646|NCT03533660|144179525|SUPERIORITY||||||>|0.05||||||Applies to SOCRATES total scores and subscales (recognition, ambivalence, and taking steps) at intake and 3 months|t-test, 2 sided|||||||>.05
72327647|NCT03533660|144179526|SUPERIORITY||||||>|0.05||||||Applies to alcohol self-efficacy scale total score and subscales scores at intake, 6 weeks and 3 months|t-test, 2 sided|||||||>.05
72327648|NCT00996658|144179529|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.57|||<|0.0001||95.0|-0.83|-0.31|||ANCOVA|ANCOVA model included terms for treatment, baseline HbA1c and centre||||-0.31|-0.83|< 0.0001
72327649|NCT00996658|144179530|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.41|||<|0.0001||95.0|-0.61|-0.21|||ANCOVA|ANCOVA model included terms for treatment, baseline HbA1c and centre||||-0.21|-0.61|< 0.0001
72327650|NCT00996658|144179531|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.54|||<|0.0001||95.0|-0.79|-0.28|||ANCOVA|ANCOVA model included terms for treatment, baseline HbA1c and centre||||-0.28|-0.79|< 0.0001
72327651|NCT00996658|144179532|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.54|||<|0.0001||95.0|-0.8|-0.29|||ANCOVA|ANCOVA model included terms for treatment, baseline HbA1c and centre||||-0.29|-0.80|< 0.0001
72327652|NCT00996658|144179533|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.939||||0.0033|TWO_SIDED|95.0|1.432|6.032|||Regression, Logistic|||Linagliptin vs Placebo||6.032|1.432|0.0033
72327653|NCT00996658|144179534|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.902||||0.0074|TWO_SIDED|95.0|1.44|10.572|||Regression, Logistic|||Linagliptin vs Placebo||10.572|1.440|0.0074
72327654|NCT00996658|144179535|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.059||||0.0071|TWO_SIDED|95.0|1.216|3.485|||Regression, Logistic|||Linagliptin vs. Placebo||3.485|1.216|0.0071
72327655|NCT00996658|144179536|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.4||||0.028||95.0|-19.6|-1.1|||ANCOVA|ANCOVA model included terms for treatment, baseline HbA1c, baseline FPG, and centre||||-1.1|-19.6|0.0280
72327656|NCT00996658|144179537|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.7||||0.0006||95.0|-24.5|-6.8|||ANCOVA|ANCOVA model included terms for treatment, baseline HbA1c, baseline FPG, and centre||||-6.8|-24.5|0.0006
72327657|NCT00996658|144179538|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.9||||0.021||95.0|-20.2|-1.7|||ANCOVA|ANCOVA model included terms for treatment, baseline HbA1c, baseline FPG, and centre||||-1.7|-20.2|0.0210
72327658|NCT00996658|144179539|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.2||||0.2137||95.0|-16.0|3.6|||ANCOVA|ANCOVA model included terms for treatment, baseline HbA1c, baseline FPG, and centre||||3.6|-16.0|0.2137
72327659|NCT04446312|144179551|NON_INFERIORITY|The pre-defined non-inferiority margin was 10%.|Risk Difference (RD)|0.15|||<|0.001|TWO_SIDED|95.0|-3.97|4.27|||Mantel Haenszel|||||4.27|-3.97|<0.001
72327660|NCT00200967|144179579|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|7.0||0.99||95.0|-14.0|14.0|||Mixed Models Analysis||The comparison represents the difference between Arg/Arg and Gly/Gly participants based on the change between placebo salmeterol and active salmeterol for AM PEF rate.|A mixed-effects linear model was applied to account for the repeated measurements within each treatment period of the crossover design. A sample size of 40 participants per genotype was required to detect a difference of 25 L/min in AM PEF (and relevant effect sizes for secondary outcomes) with a two-sided, 0.05 significance level test with 90% statistical power and a 15% drop-out rate.||14|-14|0.99
72327661|NCT00200967|144179580|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0|STANDARD_ERROR_OF_MEAN|7.0||0.82||95.0|-15.0|12.0|||Mixed Models Analysis||The comparison represents the difference between Arg/Arg and Gly/Gly participants based on the change between placebo salmeterol and active salmeterol for PM PEF rate.|A mixed-effects linear model was applied to account for the repeated measurements within each treatment period of the crossover design.||12|-15|0.82
72327662|NCT00200967|144179581|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.5||0.31||95.0|-1.6|0.5|||Mixed Models Analysis||The comparison represents the difference between Arg/Arg and Gly/Gly participants based on the change between placebo salmeterol and active salmeterol for PEF variability.|A mixed-effects linear model was applied to account for the repeated measurements within each treatment period of the crossover design.||0.5|-1.6|0.31
72327663|NCT00200967|144179582|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.02||0.09||95.0|-0.02|0.07|||Wilcoxon (Mann-Whitney)||The comparison represents the difference between Arg/Arg and Gly/Gly participants based on the change between placebo salmeterol and active salmeterol for asthma symptoms.|A mixed-effects linear model was attempted but could not converge because very few symptoms were recorded, so a nonparametric analysis was applied.||0.07|-0.02|0.09
72327664|NCT00200967|144179583|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.1||0.25||95.0|-0.1|0.2|||Wilcoxon (Mann-Whitney)||The comparison represents the difference between Arg/Arg and Gly/Gly participants based on the change between placebo salmeterol and active salmeterol for rescue medication use.|A mixed-effects linear model was attempted but could not converge because very few usages of rescue medications were recorded, so a nonparametric analysis was applied.||0.2|-0.1|0.25
72327665|NCT00200967|144179584|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.03|STANDARD_ERROR_OF_MEAN|0.03||0.34||95.0|-0.1|0.03|||Mixed Models Analysis||The comparison represents the difference between Arg/Arg and Gly/Gly participants based on the change between placebo salmeterol and active salmeterol for Spirometry FEV1, pre-bronchodilator.|A mixed-effects linear model was applied to account for the repeated measurements within each treatment period of the crossover design.||0.03|-0.10|0.34
72327666|NCT00200967|144179585|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.03||0.91||95.0|-0.08|0.07|||Mixed Models Analysis||The comparison represents the difference between Arg/Arg and Gly/Gly participants based on the change between placebo salmeterol and active salmeterol for Spirometry FVC, pre-bronchodilator.|A mixed-effects linear model was applied to account for the repeated measurements within each treatment period of the crossover design.||0.07|-0.08|0.91
72327667|NCT00200967|144179586|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0|STANDARD_ERROR_OF_MEAN|7.0||0.93||95.0|-15.0|14.0|||Mixed Models Analysis||The comparison represents the difference between Arg/Arg and Gly/Gly participants based on the change between placebo salmeterol and active salmeterol for Spirometry PEF rate, pre-bronchodilator.|A mixed-effects linear model was applied to account for the repeated measurements within each treatment period of the crossover design.||14|-15|0.93
72327668|NCT00200967|144179587|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.14|STANDARD_ERROR_OF_MEAN|0.08||0.13||95.0|-0.04|0.31|||Mixed Models Analysis||The comparison represents the difference between Arg/Arg and Gly/Gly participants based on the change between placebo salmeterol and active salmeterol for eNO.|A mixed-effects linear model was applied to the natural logarithm of eNO to account for the repeated measurements within each treatment period of the crossover design.||0.31|-0.04|0.13
72327669|NCT00200967|144179588|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.07|STANDARD_ERROR_OF_MEAN|0.24||0.79||95.0|-0.56|0.43|||Mixed Models Analysis||The comparison represents the difference between Arg/Arg and Gly/Gly participants based on the change between placebo salmeterol and active salmeterol for EBC.|A mixed-effects linear model was applied to account for the repeated measurements within each treatment period of the crossover design.||0.43|-0.56|0.79
72420127|NCT01255592|144351647|SUPERIORITY_OR_OTHER||Ratio of LS means|0.69||||0.22|TWO_SIDED|90.0|0.42|1.14|||ANCOVA|||Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.||1.14|0.42|0.220
72420128|NCT01255592|144351648|SUPERIORITY_OR_OTHER||Ratio of LS means|4.46|||<|0.001|TWO_SIDED|90.0|3.05|6.54|||ANCOVA|||Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.||6.54|3.05|<0.001
72420129|NCT01255592|144351649|SUPERIORITY_OR_OTHER||Ratio of LS means|0.92||||0.67|TWO_SIDED|90.0|0.68|1.26|||ANCOVA|||Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.||1.26|0.68|0.670
72614619|NCT04950686|144759155|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Odds Ratio (OR)|0.97||||0.888|TWO_SIDED|95.0|0.46|2.03|||Mixed Models Analysis|||||2.03|0.46|0.888
72614620|NCT04950686|144759156|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.24|STANDARD_ERROR_OF_MEAN|0.07||0.0003|TWO_SIDED||||||Mixed Models Analysis|||||||0.0003
72614621|NCT04950686|144759156|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.07|STANDARD_ERROR_OF_MEAN|0.09||0.432|TWO_SIDED||||||Mixed Models Analysis|||||||0.432
72614622|NCT04950686|144759157|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.16|STANDARD_ERROR_OF_MEAN|0.08||0.031|TWO_SIDED||||||Mixed Models Analysis|||||||0.031
72614623|NCT04950686|144759157|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.02|STANDARD_ERROR_OF_MEAN|0.09||0.794|TWO_SIDED||||||Mixed Models Analysis|||||||0.794
72327670|NCT00200967|144179589|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.32|STANDARD_ERROR_OF_MEAN|0.45||0.004||95.0|0.43|2.21|||Mixed Models Analysis||The comparison represents the difference between Arg/Arg and Gly/Gly participants based on the change between placebo salmeterol and active salmeterol for methacholine PC20.|A mixed-effects linear model was applied to the base-2 logarithm of the methacholine PC20 to account for the repeated measurements within each treatment period of the crossover design.||2.21|0.43|0.004
72614624|NCT04950686|144759158|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.08|STANDARD_ERROR_OF_MEAN|0.07||0.277|TWO_SIDED||||||Mixed Models Analysis|||||||0.277
72614625|NCT04950686|144759158|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.14|STANDARD_ERROR_OF_MEAN|0.09||0.115|TWO_SIDED||||||Mixed Models Analysis|||||||0.115
72614626|NCT03421808|144759163|SUPERIORITY|||||||0.6|||||||Chi-squared|||For categorical clinical remission data we performed a chi-square test on the IIT and completer sample using Graph-Pad Prism.||||0.6
72614627|NCT00177671|144759214|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|3.97|STANDARD_DEVIATION|2.09||0.05|TWO_SIDED|95.0|1.0|4.41|||Log Rank|||We followed the intention to treat principle. We used Kaplan-Meier curves to quantify the percentage of participants who were free of depression recurrence over time. Cox proportional hazard models quantified hazard ratios comparing the 2 treatment groups.||4.41|1.00|.05
72614628|NCT02293499|144759216|SUPERIORITY||partial eta squared|0.003||||0.043|TWO_SIDED|||||A priori threshold for statistical significance is \<.05.|Mixed Models Analysis|||For each model, partial eta squared (η2) was reported as the effect size for the change between treatment groups (Adult led vs. peer led asthma self-management). Partialη2 is the proportion of variance explained by a given variable out of the variance remaining after excluding variance explained by other predictors. Partial η2\> 0.14 indicates large effects, while η2= 0.06 to 0.14 medium and \< 0.06 small effects||||.043
72614629|NCT02293499|144759216|SUPERIORITY||partial eta squared|0.21||||0|TWO_SIDED|||||A priori threshold for statistical significance is \<.05.|Mixed Models Analysis|||For each model, partial eta squared (η2) was reported as the effect size for the overall change over time. Partialη2 is the proportion of variance explained by a given variable out of the variance remaining after excluding variance explained by other predictors. Partial η2\> 0.14 indicates large effects, while η2= 0.06 to 0.14 medium and \< 0.06 small effects||||.00
72614630|NCT02293499|144759216|SUPERIORITY||Sobel Statistic|2.4119||||0.0079|TWO_SIDED||||||Sobel|||Mediator analysis of AMI-SEI subscale on quality of life||||.0079
72614631|NCT02293499|144759216|SUPERIORITY||Sobel Statistic|2.1132||||0.0172|TWO_SIDED||||||Sobel|||Mediator analysis of ACQ Total score subscale on quality of life||||.0172
72614632|NCT02293499|144759217|SUPERIORITY||partial eta squared|0.001||||0.295|TWO_SIDED|||||A priori threshold for statistical significance is \<.05.|Mixed Models Analysis|||For each model, partial eta squared (η2) was reported as the effect size for the change between treatment groups (Adult led vs. peer led asthma self-management). Partialη2 is the proportion of variance explained by a given variable out of the variance remaining after excluding variance explained by other predictors. Partial η2\> 0.14 indicates large effects, while η2= 0.06 to 0.14 medium and \< 0.06 small effects||||0.295
72614633|NCT02293499|144759217|SUPERIORITY||partial eta squared|0.15||||0|TWO_SIDED|||||A priori threshold for statistical significance is \<.05.|Mixed Models Analysis|||For each model, partial eta squared (η2) was reported as the effect size for the overall change over time. Partialη2 is the proportion of variance explained by a given variable out of the variance remaining after excluding variance explained by other predictors. Partial η2\> 0.14 indicates large effects, while η2= 0.06 to 0.14 medium and \< 0.06 small effects||||.00
72614634|NCT02293499|144759218|SUPERIORITY||partial eta squared|0.002||||0.14|TWO_SIDED|||||A priori threshold for statistical significance is \<.05.|Mixed Models Analysis|||For each model, partial eta squared (η2) was reported as the effect size for the change between treatment groups (Adult led vs. peer led asthma self-management). Partialη2 is the proportion of variance explained by a given variable out of the variance remaining after excluding variance explained by other predictors. Partial η2\> 0.14 indicates large effects, while η2= 0.06 to 0.14 medium and \< 0.06 small effects||||.140
72614635|NCT02293499|144759218|SUPERIORITY||partial eta squared|0.15||||0|TWO_SIDED|||||A priori threshold for statistical significance is \<.05.|Mixed Models Analysis|||For each model, partial eta squared (η2) was reported as the effect size for the overall change over time. Partialη2 is the proportion of variance explained by a given variable out of the variance remaining after excluding variance explained by other predictors. Partial η2\> 0.14 indicates large effects, while η2= 0.06 to 0.14 medium and \< 0.06 small effects||||.00
72614636|NCT02293499|144759219|SUPERIORITY||partial eta squared|0.001||||0.268|TWO_SIDED|||||A priori threshold for statistical significance is \<.05.|Mixed Models Analysis|||For each model, partial eta squared (η2) was reported as the effect size for the change between treatment groups (Adult led vs. peer led asthma self-management). Partialη2 is the proportion of variance explained by a given variable out of the variance remaining after excluding variance explained by other predictors. Partial η2\> 0.14 indicates large effects, while η2= 0.06 to 0.14 medium and \< 0.06 small effects||||.268
72614637|NCT02293499|144759219|SUPERIORITY||partial eta squared|0.06||||0.14|TWO_SIDED|||||A priori threshold for statistical significance is \<.05.|Mixed Models Analysis|||For each model, partial eta squared (η2) was reported as the effect size for the overall change over time. Partialη2 is the proportion of variance explained by a given variable out of the variance remaining after excluding variance explained by other predictors. Partial η2\> 0.14 indicates large effects, while η2= 0.06 to 0.14 medium and \< 0.06 small effects||||.14
72614638|NCT02293499|144759220|SUPERIORITY||partial eta squared|0.001||||0.238|TWO_SIDED|||||A priori threshold for statistical significance is \<.05.|Mixed Models Analysis|||For each model, partial eta squared (η2) was reported as the effect size for the change between treatment groups (Adult led vs. peer led asthma self-management). Partialη2 is the proportion of variance explained by a given variable out of the variance remaining after excluding variance explained by other predictors. Partial η2\> 0.14 indicates large effects, while η2= 0.06 to 0.14 medium and \< 0.06 small effects||||.238
72420130|NCT01255592|144351650|SUPERIORITY_OR_OTHER||Ratio of LS means|0.99||||0.968|TWO_SIDED|90.0|0.78|1.27|||ANCOVA|||Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.||1.27|0.78|0.968
72420131|NCT01255592|144351651|SUPERIORITY_OR_OTHER||Ratio of LS means|1.43||||0.193|TWO_SIDED|90.0|0.91|2.24|||ANCOVA|||Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.||2.24|0.91|0.193
72420132|NCT01255592|144351652|SUPERIORITY_OR_OTHER||Ratio of LS means|3.24|||<|0.001|TWO_SIDED|90.0|2.19|4.79|||ANCOVA|||Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.||4.79|2.19|<0.001
72614639|NCT02293499|144759220|SUPERIORITY||partial eta squared|0.03||||0.43|TWO_SIDED|||||A priori threshold for statistical significance is \<.05.|Mixed Models Analysis|||For each model, partial eta squared (η2) was reported as the effect size for the overall change over time. Partialη2 is the proportion of variance explained by a given variable out of the variance remaining after excluding variance explained by other predictors. Partial η2\> 0.14 indicates large effects, while η2= 0.06 to 0.14 medium and \< 0.06 small effects||||.43
72614640|NCT02293499|144759220|SUPERIORITY||Slope|-0.203||||0.024|TWO_SIDED||||||Mixed Models Analysis|||||||.024
72614641|NCT02293499|144759221|SUPERIORITY||partial eta squared|0.0||||0.484|TWO_SIDED|||||A priori threshold for statistical significance is \<.05.|Mixed Models Analysis|||For each model, partial eta squared (η2) was reported as the effect size for the change between treatment groups (Adult led vs. peer led asthma self-management). Partialη2 is the proportion of variance explained by a given variable out of the variance remaining after excluding variance explained by other predictors. Partial η2\> 0.14 indicates large effects, while η2= 0.06 to 0.14 medium and \< 0.06 small effects||||.484
72614642|NCT02293499|144759221|SUPERIORITY||partial eta squared|0.12||||0|TWO_SIDED|||||A priori threshold for statistical significance is \<.05.|Mixed Models Analysis|||For each model, partial eta squared (η2) was reported as the effect size for the overall change over time. Partialη2 is the proportion of variance explained by a given variable out of the variance remaining after excluding variance explained by other predictors. Partial η2\> 0.14 indicates large effects, while η2= 0.06 to 0.14 medium and \< 0.06 small effects||||.00
72614643|NCT02293499|144759222|SUPERIORITY||partial eta squared|0.0||||0.648|TWO_SIDED|||||A priori threshold for statistical significance is \<.05.|Mixed Models Analysis|||For each model, partial eta squared (η2) was reported as the effect size for the change between treatment groups (Adult led vs. peer led asthma self-management). Partialη2 is the proportion of variance explained by a given variable out of the variance remaining after excluding variance explained by other predictors. Partial η2\> 0.14 indicates large effects, while η2= 0.06 to 0.14 medium and \< 0.06 small effects||||.648
72614644|NCT02293499|144759222|SUPERIORITY||partial eta squared|0.07||||0.04|TWO_SIDED|||||A priori threshold for statistical significance is \<.05.|Mixed Models Analysis|||For each model, partial eta squared (η2) was reported as the effect size for the overall change over time. Partialη2 is the proportion of variance explained by a given variable out of the variance remaining after excluding variance explained by other predictors. Partial η2\> 0.14 indicates large effects, while η2= 0.06 to 0.14 medium and \< 0.06 small effects||||.04
72614645|NCT02293499|144759223|SUPERIORITY||partial eta squared|0.003||||0.02|TWO_SIDED|||||A priori threshold for statistical significance is \<.05.|Mixed Models Analysis|||For each model, partial eta squared (η2) was reported as the effect size for the change between treatment groups (Adult led vs. peer led asthma self-management). Partialη2 is the proportion of variance explained by a given variable out of the variance remaining after excluding variance explained by other predictors. Partial η2\> 0.14 indicates large effects, while η2= 0.06 to 0.14 medium and \< 0.06 small effects||||.020
72614646|NCT02293499|144759223|SUPERIORITY||partial eta squared|0.04||||0.23|TWO_SIDED|||||A priori threshold for statistical significance is \<.05|Mixed Models Analysis|||For each model, partial eta squared (η2) was reported as the effect size for the overall change over time. Partialη2 is the proportion of variance explained by a given variable out of the variance remaining after excluding variance explained by other predictors. Partial η2\> 0.14 indicates large effects, while η2= 0.06 to 0.14 medium and \< 0.06 small effects||||.23
72614647|NCT02293499|144759224|SUPERIORITY||partial eta squared|0.002||||0.049|TWO_SIDED|||||A priori threshold for statistical significance is \<.05.|Mixed Models Analysis|||For each model, partial eta squared (η2) was reported as the effect size for the change between treatment groups (Adult led vs. peer led asthma self-management). Partialη2 is the proportion of variance explained by a given variable out of the variance remaining after excluding variance explained by other predictors. Partial η2\> 0.14 indicates large effects, while η2= 0.06 to 0.14 medium and \< 0.06 small effects||||.049
72614648|NCT02293499|144759224|SUPERIORITY||partial eta squared|0.12||||0|TWO_SIDED|||||A priori threshold for statistical significance is \<.05|Mixed Models Analysis|||For each model, partial eta squared (η2) was reported as the effect size for the overall change over time. Partialη2 is the proportion of variance explained by a given variable out of the variance remaining after excluding variance explained by other predictors. Partial η2\> 0.14 indicates large effects, while η2= 0.06 to 0.14 medium and \< 0.06 small effects||||.00
72614649|NCT02293499|144759224|SUPERIORITY||Slope|-0.294||||0.004|TWO_SIDED||||||Mixed Models Analysis|||||||.004
72614650|NCT02293499|144759224|SUPERIORITY||Sobel Statistic|-2.3505||||0.0093|TWO_SIDED||||||Sobel|||Mediator analysis of AMI-SEI subscale on ACQ total||||.0093
72614651|NCT05370326|144759227|SUPERIORITY||Mean Difference (Net)|0.89||||0.69|TWO_SIDED|95.0|-3.67|5.46|||t-test, 2 sided|||||5.46|-3.67|0.69
72614652|NCT05370326|144759232|SUPERIORITY||Mean Difference (Net)|0.23||||0.67|TWO_SIDED|95.0|-0.89|1.36|||t-test, 2 sided|||||1.36|-0.89|0.67
72614653|NCT05370326|144759233|SUPERIORITY||Mean Difference (Net)|0.59||||0.5|TWO_SIDED|95.0|-1.16|2.34|||t-test, 2 sided|||||2.34|-1.16|0.50
72614654|NCT05370326|144759234|SUPERIORITY||Mean Difference (Net)|0.2||||0.74|TWO_SIDED|95.0|-1.09|1.51|||t-test, 2 sided|||||1.51|-1.09|0.74
72614655|NCT05370326|144759236|SUPERIORITY|||||||0.33|||||||Chi-squared|||||||0.33
72614656|NCT05370326|144759237|SUPERIORITY|||||||0.47|||||||Chi-squared|||||||0.47
72420133|NCT01255592|144351653|SUPERIORITY_OR_OTHER||Ratio of LS means|1.02||||0.917|TWO_SIDED|90.0|0.71|1.48|||ANCOVA|||Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.||1.48|0.71|0.917
72327671|NCT00200967|144179590|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.12||0.89||95.0|-0.23|0.26|||Mixed Models Analysis||The comparison represents the difference between Arg/Arg and Gly/Gly participants based on the change between placebo salmeterol and active salmeterol for ACQ.|A mixed-effects linear model was applied to account for the repeated measurements within each treatment period of the crossover design.||0.26|-0.23|0.89
72327672|NCT01444430|144179599|NON_INFERIORITY_OR_EQUIVALENCE|The upper limit of the 95% CI of the hazard ratio will be used to assess statistical non-inferiority (non-inferiority margin=2).|Hazard Ratio (HR)|1.073|||||TWO_SIDED|95.0|0.698|1.65|||Regression, Cox|||||1.650|0.698|
72327673|NCT01444430|144179600|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.835||||0.002|TWO_SIDED|95.0|0.745|0.937|||Regression, Cox|||||0.937|0.745|0.002
72327674|NCT01444430|144179601|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.4|STANDARD_ERROR_OF_MEAN|0.5|<|0.001|TWO_SIDED|95.0|3.3|5.4|||ANOVA|||||5.4|3.3|<0.001
72327675|NCT01444430|144179602|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.6|STANDARD_ERROR_OF_MEAN|0.6||0.272|TWO_SIDED|95.0|-0.5|1.7|||ANOVA|||||1.7|-0.5|0.272
72327676|NCT01444430|144179603|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.0|<|0.001|TWO_SIDED|95.0|-0.2|-0.1|||ANOVA|||||-0.1|-0.2|<0.001
72327677|NCT01444430|144179604|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.08|STANDARD_ERROR_OF_MEAN|0.01|<|0.001|TWO_SIDED|95.0|-0.1|-0.06|||ANCOVA|||||-0.06|-0.10|<0.001
72327678|NCT01444430|144179605|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.2||0.004|TWO_SIDED|95.0|-1.0|-0.2|||ANOVA|||||-0.2|-1.0|0.004
72327679|NCT01444430|144179606|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.739||||0.095|TWO_SIDED|95.0|0.518|1.055|||Regression, Cox|||||1.055|0.518|0.095
72327680|NCT00276406|144179614|SUPERIORITY_OR_OTHER||||||<|0.01||95.0|||||ANCOVA|||Analysis was adjusted for BMI and baseline values and incorporated Bonferroni corrections.||||<0.01
72327681|NCT00276406|144179618|SUPERIORITY_OR_OTHER|||||||0.096||95.0|||||ANCOVA|||Analysis was adjusted for BMI and baseline values and incorporated Bonferroni corrections.||||0.096
72327682|NCT00276406|144179619|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||ANCOVA|||||||0.02
72327683|NCT00276406|144179620|SUPERIORITY_OR_OTHER|||||||0.005||95.0|||||ANCOVA|||Bowel diaries were analyzed by computing the mean scores for the 9-day baseline period and separately for the last 7 days of the treatment period (i.e., when the pyridostigmine dose was stable in each subject.) Individual subject treatment period mean bowel function scores were then compared using a similar ANCOVA model, with the corresponding individual subject baseline mean bowel function score and gender as covariates.||||0.005
72420134|NCT01255592|144351654|SUPERIORITY_OR_OTHER||Ratio of LS means|0.17||||0.111|TWO_SIDED|90.0|0.03|1.08|||ANCOVA|||Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.||1.08|0.03|0.111
72327684|NCT00276406|144179621|SUPERIORITY_OR_OTHER||||||<|0.04||95.0|||||ANCOVA|||Bowel diaries were analyzed by computing the mean scores for the 9-day baseline period and separately for the last 7 days of the treatment period (i.e., when the pyridostigmine dose was stable in each subject.) Individual subject treatment period mean bowel function scores were then compared using a similar ANCOVA model, with the corresponding individual subject baseline mean bowel function score and gender as covariates.||||<0.04
72327685|NCT02297815|144179626|SUPERIORITY_OR_OTHER||Score difference|-1.4||||0.008|TWO_SIDED|95.0|-2.44|-0.36|||Weighted linear regression|Propensity-score based full matching performed. Average treatment effect weights calculated and applied to a weighted linear regression.|Narrow antibiotics is the reference group. A score difference less than zero indicates that broad spectrum antibiotics are associated with a lower (poorer) health related quality of life score.|Propensity-score based full matching performed using patient and physician-level characteristics. Average treatment effect weights calculated and applied to a weighted linear regression.||-0.36|-2.44|0.008
72327686|NCT02297815|144179627|SUPERIORITY_OR_OTHER||Risk Difference (RD)|2.4||||0.39|TWO_SIDED|95.0|-3.1|7.9|||Weighted logistic regression|Propensity-score based full matching. Average treatment effect weights calculated and applied to a weighted logistic regression.|Broad spectrum antibiotics are the reference. A risk difference more than 0 indicates that the broad spectrum antibiotics had a higher risk of adverse outcome|Propensity-score based full matching performed using patient and physician-level characteristics. Average treatment effect weights calculated and applied to a weighted logistic regression. Risk difference obtained by marginal standardization.||7.9|-3.1|0.39
72614657|NCT00884065|144759280|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.72|STANDARD_ERROR_OF_MEAN|4.08|>|0.05|TWO_SIDED|95.0|-9.93|6.49|||t-test, 2 sided|||||6.49|-9.93|>0.05
72327687|NCT02297815|144179628|SUPERIORITY_OR_OTHER||Risk Difference (RD)|1.5||||0.59|TWO_SIDED|95.0|-3.9|6.8|||Weighted logistic regression|Propensity-score based full matching. Average treatment effect weights calculated and applied to a weighted logistic regression.|Broad spectrum antibiotics are the reference. A risk difference more than 0 indicates that the broad spectrum antibiotics had a higher risk of adverse outcome|Propensity-score based full matching performed using patient and physician-level characteristics. Average treatment effect weights calculated and applied to a weighted logistic regression. Risk difference obtained by marginal standardization.||6.8|-3.9|0.59
72327688|NCT02297815|144179629|SUPERIORITY_OR_OTHER||Risk Difference (RD)|12.2|||<|0.001|TWO_SIDED|95.0|7.3|17.2|||Weighted logistic regression|Propensity-score based full matching. Average treatment effect weights calculated and applied to a weighted logistic regression.|Broad spectrum antibiotics are the reference. A risk difference more than 0 indicates that the broad spectrum antibiotics had a higher risk of adverse outcome|Propensity-score based full matching performed using patient and physician-level characteristics. Average treatment effect weights calculated and applied to a weighted logistic regression. Risk difference obtained by marginal standardization.||17.2|7.3|<0.001
72420135|NCT01255592|144351655|SUPERIORITY_OR_OTHER||Ratio of LS means|1.33||||0.367|TWO_SIDED|90.0|0.79|2.26|||ANCOVA|||Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.||2.26|0.79|0.367
72614658|NCT00884065|144759281|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.4|STANDARD_ERROR_OF_MEAN|2.83|<|0.01||95.0|5.72|17.08|||t-test, 2 sided|||||17.08|5.72|<0.01
72614659|NCT00884065|144759282|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.24|STANDARD_ERROR_OF_MEAN|2.59|<|0.01|TWO_SIDED|95.0|2.03|12.45|||t-test, 2 sided|||||12.45|2.03|<0.01
72420136|NCT01255592|144351656|SUPERIORITY_OR_OTHER||Ratio of LS means|1.54||||0.112|TWO_SIDED|90.0|0.98|2.4|||ANCOVA|||Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.||2.40|0.98|0.112
72420137|NCT01255592|144351657|SUPERIORITY_OR_OTHER||Ratio of LS means|1.05||||0.241|TWO_SIDED|90.0|0.98|1.12|||ANCOVA|||Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.||1.12|0.98|0.241
72614660|NCT00884065|144759283|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.92|STANDARD_ERROR_OF_MEAN|1.72|>|0.05|TWO_SIDED|95.0|-1.53|5.37|||t-test, 2 sided|||||5.37|-1.53|>0.05
72614661|NCT00884065|144759284|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.6|STANDARD_ERROR_OF_MEAN|2.18|>|0.05|TWO_SIDED|95.0|-3.81|5.01|||t-test, 2 sided|||||5.01|-3.81|>0.05
72614662|NCT00884065|144759285|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.08|STANDARD_ERROR_OF_MEAN|1.49|<|0.01|TWO_SIDED|95.0|0.08|6.09|||t-test, 2 sided|||||6.09|0.08|<0.01
72614663|NCT02299167|144759294|OTHER|The ED50% of spinal bupivacaine was estimated using a modified Dixon's up-and-down method|Mean (95% CI) of effective dose in 90% (|1.9|||||TWO_SIDED|95.0|1.7|2.1|||||The ED50% of spinal bupivacaine was estimated using a modified Dixon's up-and-down method|Descriptive statistics were considered to calculate the mathematic mean (SD) of demographic, surgical, and other postoperative continuous data and to calculate the median (range) of sensory and motor block levels, as well as the degree of patient and surgeon satisfaction||2.1|1.7|
72614664|NCT04937387|144759357|OTHER||Least Squares Mean Difference|0.059|STANDARD_ERROR_OF_MEAN|0.0449|||TWO_SIDED|95.0|-0.03|0.147|||||||Analysis performed using mixed effect model for repeated measures with covariates of treatment, age, sex, eCRF-reported pre-study ICS dosage at screening (med, high), baseline trough FEV1 value, visit, and interaction terms for baseline trough FEV1-by-visit and treatment-by-visit, covariance structure = unstructured.|0.147|-0.030|
72614665|NCT04937387|144759357|OTHER||Posterior Mean|0.076|||||TWO_SIDED|90.0|0.025|0.115|||||Analysis was conducted in the Bayesian paradigm using the pre-specified mixture prior distribution, which was updated with the treatment difference between FF/UMEC/VI 100/62.5/25 and FF/VI 100/25 estimated in the MMRM analysis.|||0.115|0.025|
72614666|NCT04937387|144759357|OTHER||Posterior Median|0.079|||||TWO_SIDED|95.0|0.005|0.123|||||Analysis was conducted in the Bayesian paradigm using the pre-specified mixture prior distribution, which was updated with the treatment difference between FF/UMEC/VI 100/62.5/25 and FF/VI 100/25 estimated in the MMRM analysis.|||0.123|0.005|
72614667|NCT04937387|144759358|OTHER||Least Squares Mean Difference|-0.005|STANDARD_ERROR_OF_MEAN|0.0455|||TWO_SIDED|95.0|-0.094|0.084|||||||Analysis performed using mixed effect model for repeated measures with covariates of treatment, age, sex, eCRF-reported pre-study ICS dosage at screening (med, high), baseline trough FEV1 value, visit, and interaction terms for baseline trough FEV1-by-visit and treatment-by-visit, covariance structure = unstructured.|0.084|-0.094|
72420138|NCT01255592|144351658|SUPERIORITY_OR_OTHER||Ratio of LS means|5.5|||<|0.001|TWO_SIDED|90.0|4.18|7.23|||ANCOVA|||Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.||7.23|4.18|<0.001
72614668|NCT04937387|144759358|OTHER||Posterior Mean|0.023|||||TWO_SIDED|90.0|-0.071|0.103|||||Analysis was conducted in the Bayesian paradigm using the pre-specified mixture prior distribution, which was updated with the treatment difference between FF/UMEC/VI 200/62.5/25 and FF/VI 200/25 estimated in the MMRM analysis.|||0.103|-0.071|
72614669|NCT04937387|144759358|OTHER||Posterior Median|0.023||||||95.0|-0.086|0.11|||||Analysis was conducted in the Bayesian paradigm using the pre-specified mixture prior distribution, which was updated with the treatment difference between FF/UMEC/VI 200/62.5/25 and FF/VI 200/25 estimated in the MMRM analysis.|||0.110|-0.086|
72614670|NCT04937387|144759359|OTHER||Least Squares Mean Difference|-0.028|STANDARD_ERROR_OF_MEAN|0.0823|||TWO_SIDED|95.0|-0.19|0.134|||||||Analysis performed using mixed effect model for repeated measures with covariates of treatment, age, sex, eCRF-reported pre-study ICS dosage at screening (med, high), baseline ACQ-7 total score, visit, and interaction terms for baseline ACQ-7 total score-by-visit and treatment-by-visit, covariance structure = unstructured.|0.134|-0.190|
72614671|NCT04937387|144759359|OTHER||Least Squares Mean Difference|0.112|STANDARD_ERROR_OF_MEAN|0.0832|||TWO_SIDED|95.0|-0.052|0.276|||||||Analysis performed using mixed effect model for repeated measures with covariates of treatment, age, sex, eCRF-reported pre-study ICS dosage at screening (med, high), baseline ACQ-7 total score, visit, and interaction terms for baseline ACQ-7 total score-by-visit and treatment-by-visit, covariance structure = unstructured.|0.276|-0.052|
72420139|NCT01255592|144351659|SUPERIORITY_OR_OTHER||Ratio of LS means|1.16||||0.281|TWO_SIDED|90.0|0.92|1.47|||ANCOVA|||Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.||1.47|0.92|0.281
72420140|NCT01255592|144351660|SUPERIORITY_OR_OTHER||Ratio of LS means|1.56||||0.001|TWO_SIDED|90.0|1.28|1.91|||ANCOVA|||Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.||1.91|1.28|0.001
72420141|NCT01255592|144351661|SUPERIORITY_OR_OTHER||Ratio of LS means|6.07|||<|0.001|TWO_SIDED|90.0|4.42|8.35|||ANCOVA|||Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.||8.35|4.42|<0.001
72420142|NCT00089141|144351686|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.66||||0.22||95.0|0.7|3.7||P values are 2 sided and are based on likelihood ratio statistics.|Regression, Cox|Analysis for all endpoints was stratified by number of affected organs and type of conditioning regimen.|For all analyses, MMF arm in numerator, and placebo arm in denominator. Hazard ratio estimate includes 3 efficacy success events that occurred after two years in the placebo arm.|||3.7|0.7|.22
72420143|NCT00089141|144351687|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.65||||0.03||95.0|1.1|2.6|||Regression, Cox|Statistical analysis did not count treatment continuing beyond 2 years as efficacy failure (n = 2 in each arm).||||2.6|1.1|.03
72420144|NCT00089141|144351688|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.19||||0.55||95.0|0.7|2.1|||Regression, Cox|||||2.1|0.7|.55
72420145|NCT00089141|144351689|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.61||||0.48||95.0|0.4|6.0|||Regression, Cox|||||6.0|0.4|.48
72420146|NCT00089141|144351690|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.74||||0.17||95.0|0.8|3.9|||Regression, Cox|adjusted for risk category||||3.9|0.8|.17
72420147|NCT00089141|144351691|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.62||||0.41||95.0|0.5|5.0|||Regression, Cox|||||5.0|0.5|.41
72420148|NCT00089141|144351692|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.69||||0.14||95.0|0.9|3.2|||Regression, Cox|||||3.2|0.9|.14
72420149|NCT00089141|144351693|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.99||||0.1||95.0|0.9|4.3|||Regression, Cox|||||4.3|0.9|.10
72420150|NCT00089141|144351694|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.28||||0.34||95.0|0.08|2.1|||Regression, Cox|||||2.1|.08|.34
72420151|NCT00089141|144351695|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.51||||0.28||95.0|0.7|3.2|||Regression, Cox|||||3.2|0.7|.28
72420152|NCT05131165|144351696|SUPERIORITY|||||||0.056||||||A priori threshold for statistical significance (alpha) = 0.05|ANCOVA|||The analyses utilized control as the reference group, and thus, the values reported include control mean and standard error as the reference value (derived from an ordinary least squared regression without controls). The results for the intervention groups are derived from the multiple regression model that controlled for other participant characteristics, including demographics, intrinsic motivation and habit strength at baseline.||||0.056
72420153|NCT05131165|144351696|SUPERIORITY|||||||0.062||||||A priori threshold for statistical significance (alpha) = 0.05|ANCOVA|||The analyses utilized control as the reference group, and thus, the values reported include control mean and standard error as the reference value (derived from an ordinary least squared regression without controls). The results for the intervention groups are derived from the multiple regression model that controlled for other participant characteristics, including demographics, intrinsic motivation and habit strength at baseline.||||0.062
72420154|NCT05131165|144351697|SUPERIORITY|||||||0.364||||||A priori threshold for statistical significance (alpha) = 0.05|ANCOVA|||The analyses utilized control as the reference group, and thus, the values reported include control mean and standard error as the reference value (derived from an ordinary least squared regression without controls). The results for the intervention groups are derived from the multiple regression model that controlled for other participant characteristics, including demographics, intrinsic motivation and habit strength at baseline.||||0.364
72420155|NCT05131165|144351697|SUPERIORITY|||||||0.409||||||A priori threshold for statistical significance (alpha) = 0.05|ANCOVA|||The analyses utilized control as the reference group, and thus, the values reported include control mean and standard error as the reference value (derived from an ordinary least squared regression without controls). The results for the intervention groups are derived from the multiple regression model that controlled for other participant characteristics, including demographics, intrinsic motivation and habit strength at baseline.||||0.409
72420156|NCT05131165|144351698|SUPERIORITY|||||||0.158||||||A priori threshold for statistical significance (alpha) = 0.05|ANCOVA|||The analyses utilized control as the reference group, and thus, the values reported include control mean and standard error as the reference value (derived from an ordinary least squared regression without controls). The results for the intervention groups are derived from the multiple regression model that controlled for other participant characteristics, including demographics, intrinsic motivation and habit strength at baseline.||||0.158
72420157|NCT05131165|144351698|SUPERIORITY|||||||0.017||||||A priori threshold for statistical significance (alpha) = 0.05|ANCOVA|||The analyses utilized control as the reference group, and thus, the values reported include control mean and standard error as the reference value (derived from an ordinary least squared regression without controls). The results for the intervention groups are derived from the multiple regression model that controlled for other participant characteristics, including demographics, intrinsic motivation and habit strength at baseline.||||0.017
72420158|NCT05131165|144351699|SUPERIORITY|||||||0.654||||||A priori threshold for statistical significance (alpha) = 0.05|ANCOVA|||The analyses utilized control as the reference group, and thus, the values reported include control mean and standard error as the reference value (derived from an ordinary least squared regression without controls). The results for the intervention groups are derived from the multiple regression model that controlled for other participant characteristics, including demographics, intrinsic motivation and habit strength at baseline.||||0.654
72420159|NCT05131165|144351699|SUPERIORITY|||||||0.035||||||A priori threshold for statistical significance (alpha) = 0.05|ANCOVA|||The analyses utilized control as the reference group, and thus, the values reported include control mean and standard error as the reference value (derived from an ordinary least squared regression without controls). The results for the intervention groups are derived from the multiple regression model that controlled for other participant characteristics, including demographics, intrinsic motivation and habit strength at baseline.||||0.035
72369769|NCT02840799|144249850|SUPERIORITY||Slope|-0.3118||||0.361|TWO_SIDED|95.0|-0.99|0.37||Assuming a 90% retention rate, enrolling 84 subjects in this cross-over trial will have 80% power to detect such an effect size in the intervention induced change of our study endpoints, with a two-sided α=0.05.|Mixed Models Analysis|||The mixed model analysis provided an assessment of the treatment effect on each continuous outcome of interest while controlling for effects of other covariates such as period, sequence, and a random subject effect.||0.37|-0.99|0.361
72369770|NCT02840799|144249851|SUPERIORITY||Mean Difference (Final Values)|-0.1532142|STANDARD_ERROR_OF_MEAN|-0.1532142||0.7707|TWO_SIDED|95.0|-1.1998786|0.8934502||Assuming a 90% retention rate, enrolling 84 subjects in this cross-over trial will have 80% power to detect such an effect size in the intervention induced change of our study endpoints, with a two-sided α=0.05.|t-test, 2 sided|t= -0.29271, df=61, p=0.7707||||0.8934502|-1.1998786|0.7707
72420160|NCT05131165|144351701|SUPERIORITY|||||||0.5468|||||||t-test, 2 sided|||The analyses compared the change in viral suppression status of the participants from baseline to month 9. For each participant, we derived the change in viral suppression status by subtracting two binary variables - one indicating whether the participant was virally suppressed at baseline (based on their chart records from around 3 months prior to baseline) and the other indicating whether the participant was virally suppressed at around month 9 of the study.||||0.5468
72420161|NCT05131165|144351701|SUPERIORITY|||||||0.5255|||||||t-test, 2 sided|||The analyses compared the change in viral suppression status of the participants from baseline to month 9. For each participant, we derived the change in viral suppression status by subtracting two binary variables - one indicating whether the participant was virally suppressed at baseline (based on their chart records from around 3 months prior to baseline) and the other indicating whether the participant was virally suppressed at around month 9 of the study.||||0.5255
72369771|NCT02840799|144249851|SUPERIORITY||Slope|0.18872||||0.724|TWO_SIDED|95.0|-0.88|1.25||Assuming a 90% retention rate, enrolling 84 subjects in this cross-over trial will have 80% power to detect such an effect size in the intervention induced change of our study endpoints, with a two-sided α=0.05.|Mixed Models Analysis|||The mixed model analysis provided an assessment of the treatment effect on each continuous outcome of interest while controlling for effects of other covariates such as period, sequence, and a random subject effect.||1.25|-0.88|0.724
72369772|NCT02840799|144249852|SUPERIORITY||Mean Difference (Final Values)|0.3262821|STANDARD_ERROR_OF_MEAN|0.2333465||0.1680825|TWO_SIDED|95.0|-0.1421806|0.7947447||Assuming a 90% retention rate, enrolling 84 subjects in this cross-over trial will have 80% power to detect such an effect size in the intervention induced change of our study endpoints, with a two-sided α=0.05.|t-test, 2 sided|t=1.3983, df=51, p=0.1681||||0.7947447|-0.1421806|0.1680825
72327689|NCT02297815|144179630|SUPERIORITY_OR_OTHER||Risk Difference (RD)|4.9||||0.09|TWO_SIDED|95.0|-0.8|10.6|||Weighted logistic regression|Propensity-score based full matching. Average treatment effect weights calculated and applied to a weighted logistic regression.|Broad spectrum antibiotics are the reference. A risk difference more than 0 indicates that the broad spectrum antibiotics had a higher risk of adverse outcome|Propensity-score based full matching performed using patient and physician-level characteristics. Average treatment effect weights calculated and applied to a weighted logistic regression. Risk difference obtained by marginal standardization.||10.6|-0.8|0.09
72327690|NCT02297815|144179631|SUPERIORITY||Risk Difference (RD)|4.6||||0.07|TWO_SIDED|95.0|-0.3|9.6|||Weighted logistic regression|Propensity-score based full matching. Average treatment effect weights calculated and applied to a weighted logistic regression.|Broad spectrum antibiotics are the reference. A risk difference more than 0 indicates that the broad spectrum antibiotics had a higher risk of adverse outcome|Propensity-score based full matching performed using patient and physician-level characteristics. Average treatment effect weights calculated and applied to a weighted logistic regression. Risk difference obtained by marginal standardization.||9.6|-0.3|0.07
72327691|NCT01537315|144179657|SUPERIORITY_OR_OTHER|||||||0.4521|TWO_SIDED|||||A paired comparison between baseline CRP values with values obtained after 1, 3, and 6 months of treatment was conducted, with a p-value of 0.05 used as the a priori threshold of statistical significance.|ANOVA|||||||0.4521
72327692|NCT02197572|144179659|OTHER||Least Squares Mean|-2.2|||||ONE_SIDED|95.0||2.2||||||Change from Baseline at 0.25 Hours Postdose||2.2||
72327693|NCT02197572|144179659|OTHER||Least Squares Mean|-8.3|||||ONE_SIDED|95.0||-4.0||||||Change from Baseline at 0.5 Hours Postdose||-4.0||
72327694|NCT02197572|144179659|OTHER||Least Squares Mean|-1.8|||||ONE_SIDED|95.0||2.6||||||Change from Baseline at 1 Hour Postdose||2.6||
72327695|NCT02197572|144179659|OTHER||Least Squares Mean|-2.7|||||ONE_SIDED|95.0||1.7||||||Change from Baseline at 1.5 Hours Postdose||1.7||
72327696|NCT02197572|144179659|OTHER||Least Squares Mean|-5.0|||||ONE_SIDED|95.0||-0.6||||||Change from Baseline at 2 Hours Postdose||-0.6||
72327697|NCT02197572|144179659|OTHER||Least Squares Mean|-7.6|||||ONE_SIDED|95.0||-3.2||||||Change from Baseline at 2.5 Hours Postdose||-3.2||
72327698|NCT02197572|144179659|OTHER||Least Squares Mean|-9.1|||||ONE_SIDED|95.0||-4.6||||||Change from Baseline at 3 Hours Postdose||-4.6||
72327699|NCT02197572|144179659|OTHER||Least Squares Mean|-7.2|||||ONE_SIDED|95.0||-2.9||||||Change from Baseline at 4 Hours Postdose||-2.9||
72327700|NCT02197572|144179659|OTHER||Least Squares Mean|-8.8|||||ONE_SIDED|95.0||-4.6||||||Change from Baseline at 6 Hours Postdose||-4.6||
72327701|NCT02197572|144179659|OTHER||Least Squares Mean|-2.2|||||ONE_SIDED|95.0||2.4||||||Change from Baseline at 8 Hours Postdose||2.4||
72327702|NCT02197572|144179659|OTHER||Least Squares Mean|-6.6|||||ONE_SIDED|95.0||-0.5||||||Change from Baseline at 10 Hours Postdose||-0.5||
72327703|NCT02197572|144179659|OTHER||Least Squares Mean|7.1|||||ONE_SIDED|95.0||11.4||||||Change from Baseline at 24 Hours Postdose||11.4||
72327704|NCT02197572|144179659|OTHER||Least Squares Mean|2.8|||||ONE_SIDED|95.0||8.1||||||Change from Baseline at 48 Hours Postdose||8.1||
72327705|NCT02975804|144179677|SUPERIORITY||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||< 0.05
72327706|NCT02975804|144179678|SUPERIORITY||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||< 0.05
72327707|NCT02975804|144179679|SUPERIORITY||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||< 0.05
72327708|NCT02975804|144179680|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|||||||< 0.05
72327709|NCT02975804|144179681|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|||||||< 0.05
72327710|NCT02975804|144179682|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|||||||< 0.05
72327711|NCT02975804|144179686|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|||||||< 0.05
72327712|NCT02975804|144179687|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|||||||< 0.05
72327713|NCT04263766|144179710|EQUIVALENCE|We tested whether TMS delivered to DLPFC had a difference effect on confidence compared to delivered to Vertex.|||||<|0.001|||||||t-test, 2 sided|||Our null hypothesis is TMS to DLPFC would not lead to a significant change in confidence across all 4 delay conditions compared to TMS to the vertex.||||<.001
72327714|NCT04263766|144179710|EQUIVALENCE|We tested whether TMS to DLPFC leads to equivalent increase in confidence for four delay conditions.||||||0.99|||||||ANOVA|||||||0.99
72327715|NCT04263766|144179710|EQUIVALENCE|We tested whether TMS delivered to Vertex leads to a same effect on confidence regardless of the delay conditions.||||||0.83|||||||ANOVA|||||||0.83
72327716|NCT04263766|144179711|EQUIVALENCE|We used a two-way ANOVA to test whether TMS affected Mratio differently for DLPFC and Vertex and across different delay conditions.|||||>|0.19|||||||ANOVA|||Our null hypothesis is TMS to DLPFC would not lead to a significant change in Mratio across all 4 delay conditions compared to TMS to the vertex.||||>0.19
72327717|NCT02553928|144179720|OTHER||Mean Difference (Final Values)|0.32|STANDARD_ERROR_OF_MEAN|0.19||0.097|TWO_SIDED|95.0|-0.06|0.69||Based on full analysis set|ANCOVA||The comparison is to BID memantine.|The ADCS-CGIC was analyzed based on an analysis of covariance (ANCOVA) of ADCS-CGIC score at Week 12, with treatment and site as fixed factors, and baseline score as a covariate using observed cases.||0.69|-0.06|0.097
72327718|NCT02688192|144179734|SUPERIORITY|||||||0.39|||||||ANOVA|df = 33||Effects of the intervention on changes in the General Subscale from baseline to post-intervention (3 months) were evaluated using group x time in a repeated measures analysis of variance performed in SAS using PROC GLM for participants with complete data.||||0.39
72327719|NCT02688192|144179734|SUPERIORITY|||||||0.49|||||||ANOVA|df = 33||Effects of the intervention on changes in the Sleep/Rest Subscale from baseline to post-intervention (3 months) were evaluated using group x time in a repeated measures analysis of variance performed in SAS using PROC GLM for participants with complete data.||||.49
72327720|NCT02688192|144179734|SUPERIORITY|||||||0.83|||||||ANOVA|df = 33||Effect of the intervention on changes in the Cognitive Subscale from baseline to post-intervention (3 months) were evaluated using group x time in a repeated measures analysis of variance performed in SAS using PROC GLM for participants with complete data.||||.83
72420162|NCT02298361|144351703|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.76|||||TWO_SIDED|95.0|1.6|1.93|||Generalized estimating equation|GEE model clustered by clinic, adjusted for demographics, number of visits, new/established patient at first visit, and household factors.|Adjusted odds of gaining Medicaid: intervention patients (numerator) relative to within-clinic comparison patients (denominator)|||1.93|1.60|
72327721|NCT02688192|144179735|SUPERIORITY|||||||0.98|||||||ANOVA|df = 33||Effects of the intervention on changes in the PedsQL Physical Summary score were evaluated using group x time in a repeated measures analysis of variance performed in SAS using PROC GLM for participants with complete data.||||.98
72327722|NCT02688192|144179735|SUPERIORITY|||||||0.85|||||||ANOVA|df = 29||Effects of the intervention on changes in the PedsQL Psychosocial Summary score were evaluated using group x time in a repeated measures analysis of variance performed in SAS using PROC GLM for participants with complete data.||||.85
72327723|NCT02688192|144179736|SUPERIORITY|||||||0.29|||||||ANOVA|df = 29||||||.29
72420163|NCT02298361|144351703|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.28|||||TWO_SIDED|95.0|1.91|2.72|||Generalized estimating equation|GEE model clustered by clinic, adjusted for demographics, number of visits, new/established patient at first visit, and household factors.|Adjusted odds of gaining Medicaid: intervention patients (numerator) relative to control clinic comparison patients (denominator)|||2.72|1.91|
72327724|NCT02688192|144179737|SUPERIORITY|||||||0.019|||||||ANOVA|df = 32||Effect of the intervention on changes in lower body estimated 1-RM was evaluated using group x time in a repeated measures analysis of variance performed in SAS using PROC GLM for participants with complete data||||.019
72327725|NCT02688192|144179737|SUPERIORITY|||||||0.34|||||||ANOVA|df = 32||Effect of the intervention on changes in upper body estimated 1-RM was evaluated using group x time in a repeated measures analysis of variance performed in SAS using PROC GLM for participants with complete data.||||.34
72327726|NCT00075764|144179739|OTHER||Hazard Ratio (HR)|0.8||||0.007|TWO_SIDED|95.0|0.68|0.94|||Log Rank|Two-sided stratified log-rank test||||0.94|0.68|0.007
72327727|NCT00075764|144179741|OTHER||Hazard Ratio (HR)|0.81||||0.049|TWO_SIDED|95.0|0.65|1.0|||Log Rank|A log-rank test, stratified according to prior or no prior tamoxifen therapy.||||1.00|0.65|0.049
72327728|NCT01773967|144179748|SUPERIORITY|||||||0.83|||||||Mantel Haenszel|||||||0.83
72327729|NCT01773967|144179750|SUPERIORITY|||||||0.26|||||||Van Elteren's modification Mann-Whitney|||||||0.26
72420164|NCT02298361|144351704|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.71|||||TWO_SIDED|95.0|0.53|0.94|||Generalized estimating equation|GEE model clustered by clinic, adjusted for demographics, number of visits, new/established patient at first visit, and household factors.|Adjusted odds of losing Medicaid: intervention patients (numerator) relative to within-clinic comparison patients (denominator)|||0.94|0.53|
72327730|NCT01135459|144179751|OTHER||Odds Ratio (OR)|0.7649||||0.3989|TWO_SIDED|95.0|0.4|1.4|||Regression, Logistic|||Analysis was performed using a logistic regression model with treatment and stratification factors as main factors.||1.4|0.4|0.3989
72327731|NCT01194219|144179762|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|27.8|||<|0.0001|TWO_SIDED|95.0|23.1|32.5|||Chi-squared|||||32.5|23.1|<0.0001
72327732|NCT01194219|144179763|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|17.8|||<|0.0001|TWO_SIDED|95.0|13.7|21.9|||Chi-squared|||||21.9|13.7|<0.0001
72327733|NCT01194219|144179764|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Mean|-40.78|||<|0.0001|TWO_SIDED|95.0|-46.34|-35.21|||ANCOVA|The model included treatment group as a factor and the baseline value as a covariate. The estimation and p-value were adjusted by the covariate.||||-35.21|-46.34|<0.0001
72327734|NCT01194219|144179765|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Mean|-35.3|||<|0.0001|TWO_SIDED|95.0|-39.9|-30.6|||ANCOVA|The model included treatment group as a factor and the baseline value as a covariate. The estimation and p-value were adjusted by the covariate.||||-30.6|-39.9|<0.0001
72327735|NCT01194219|144179766|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|41.7|||<|0.0001|TWO_SIDED|95.0|35.7|47.7|||Chi-squared|||||47.7|35.7|<0.0001
72327736|NCT01194219|144179767|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Mean|-24.2|||<|0.0001|TWO_SIDED|95.0|-28.7|-19.8|||ANOVA|Based on an analysis of variance model for the change from baseline at Week 16, with treatment group as a factor (an ANOVA model).||||-19.8|-28.7|<0.0001
72327737|NCT01194219|144179768|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Mean|-4.5|||<|0.0001|TWO_SIDED|95.0|-5.4|-3.6|||ANOVA||Based on an analysis of covariance model for the change from baseline at Week 16, with treatment group as a factor, the baseline value, and the treatment by baseline interaction term as covariates.|||-3.6|-5.4|<0.0001
72327738|NCT01194219|144179769|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|3.08|||<|0.0001|TWO_SIDED|95.0|1.81|4.35|||ANCOVA|The model included treatment group as a factor and the baseline value as a covariate. The estimation and p-value were adjusted by the covariate.||||4.35|1.81|<0.0001
72327739|NCT01194219|144179770|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|16.7|||<|0.0001|TWO_SIDED|95.0|12.8|20.7|||Chi-squared|||||20.7|12.8|<0.0001
72327740|NCT01194219|144179771|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|2.649|||<|0.0001|TWO_SIDED|95.0|1.768|3.969|||Log Rank|||||3.969|1.768|<0.0001
72327741|NCT04474197|144179788|SUPERIORITY||Least Squares (LS) Mean Difference|2.3|||<|0.0001|TWO_SIDED|95.0|1.5|3.1|||Mixed-effects Model for Repeated Measure|||||3.1|1.5|<0.0001
72327742|NCT04474197|144179788|SUPERIORITY||LS Mean Difference|2.3|||<|0.0001|TWO_SIDED|95.0|1.6|3.1|||Mixed-effects Model for Repeated Measure|||||3.1|1.6|<0.0001
72327743|NCT04474197|144179788|SUPERIORITY||LS Mean Difference|2.2|||<|0.0001|TWO_SIDED|95.0|1.5|2.9|||Mixed-effects Model for Repeated Measure|||||2.9|1.5|<0.0001
72327744|NCT04474197|144179790|SUPERIORITY||LS Mean Difference|3.5|||<|0.0001|TWO_SIDED|95.0|2.4|4.6|||Mixed-effects Model for Repeated Measure|||||4.6|2.4|<0.0001
72327745|NCT04474197|144179790|SUPERIORITY||LS Mean Difference|3.0|||<|0.0001|TWO_SIDED|95.0|1.9|4.0|||Mixed-effects Model for Repeated Measure|||||4.0|1.9|<0.0001
72327746|NCT04474197|144179790|SUPERIORITY||LS Mean Difference|2.7|||<|0.0001|TWO_SIDED|95.0|1.8|3.7|||Mixed-effects Model for Repeated Measure|||||3.7|1.8|<0.0001
72369773|NCT02840799|144249852|SUPERIORITY||Slope|-0.4082||||0.093|TWO_SIDED|95.0|-0.88|0.07||Assuming a 90% retention rate, enrolling 84 subjects in this cross-over trial will have 80% power to detect such an effect size in the intervention induced change of our study endpoints, with a two-sided α=0.05.|Mixed Models Analysis|||||0.07|-0.88|0.0930
72369774|NCT02840799|144249853|SUPERIORITY||Mean Difference (Final Values)|-2.116437|STANDARD_ERROR_OF_MEAN|1.176768||0.07984|TWO_SIDED|95.0|-4.4966754|0.2638017||Assuming a 90% retention rate, enrolling 84 subjects in this cross-over trial will have 80% power to detect such an effect size in the intervention induced change of our study endpoints, with a two-sided α=0.05.|t-test, 2 sided||t = -1.7985, df=39, p=0.07984|||0.2638017|-4.4966754|0.07984
72369775|NCT02840799|144249853|SUPERIORITY||Slope|1.68||||0.135|TWO_SIDED|95.0|-0.54|3.9||Assuming a 90% retention rate, enrolling 84 subjects in this cross-over trial will have 80% power to detect such an effect size in the intervention induced change of our study endpoints, with a two-sided α=0.05.|Mixed Models Analysis|||||3.90|-0.54|0.135
72369776|NCT02840799|144249854|SUPERIORITY||Mean Difference (Final Values)|-0.0192733|STANDARD_ERROR_OF_MEAN|0.01295984||0.145|TWO_SIDED|95.0|-0.0454871|0.0069404||Assuming a 90% retention rate, enrolling 84 subjects in this cross-over trial will have 80% power to detect such an effect size in the intervention induced change of our study endpoints, with a two-sided α=0.05.|t-test, 2 sided|||||0.00694040|-0.0454871|0.1450
72420165|NCT02298361|144351704|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.55|||||TWO_SIDED|95.0|0.45|0.67|||Generalized estimating equation|GEE model clustered by clinic, adjusted for demographics, number of visits, new/established patient at first visit, and household factors.|Adjusted odds of losing Medicaid: intervention patients (numerator) relative to control clinic comparison patients (denominator)|||0.67|0.45|
72420166|NCT05168579|144351713|SUPERIORITY||Odds Ratio (OR)|13.8|||<|0.001|TWO_SIDED|95.0|2.76|69.6|||Mixed Models Analysis|||||69.6|2.76|<0.001
72420167|NCT02110901|144351737|SUPERIORITY||Hazard Ratio (HR)|0.83||||0.254|TWO_SIDED|95.0|0.61|1.14|||Log Rank|||||1.14|0.61|0.254
72420168|NCT02110901|144351738|SUPERIORITY||Hazard Ratio (HR)|0.66||||0.048|TWO_SIDED|95.0|0.43|1.0|||Log Rank|||||1.00|0.43|0.048
72420169|NCT02110901|144351739|SUPERIORITY|||||||0.109|||||||Chi-squared|||||||0.109
72420170|NCT02110901|144351740|SUPERIORITY|||||||0.035|||||||Chi-squared|||||||0.035
72420171|NCT00855595|144351758|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0903|||||||ANCOVA|||||||0.0903
72420172|NCT00166296|144351783|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.4||||0.441|TWO_SIDED|95.0|0.075|2.141|||Fisher Exact|||||2.141|0.075|0.441
72420173|NCT00166296|144351784|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05||95.0|||||Chi-squared|||||||>0.05
72420174|NCT00166296|144351785|SUPERIORITY_OR_OTHER_LEGACY|||||||0.443||95.0|||||ANOVA|||||||0.443
72420175|NCT00166296|144351786|SUPERIORITY_OR_OTHER_LEGACY|||||||0.93||95.0|||||ANOVA|||||||0.930
72420176|NCT00386022|144351813|EQUIVALENCE|null hypothesis will be accepted if there is no difference in the LH response to GnRH as a function of dose in young or old postmenopausal women|||||<|0.001||||||LH % change with dose|Repeated measures ANCOVA|||||||<0.001
72420177|NCT00386022|144351813|EQUIVALENCE|null hypothesis will be accepted if there is no difference in the LH response to GnRH between younger and older postmenopausal women|||||<|0.03||||||LH % change with age|Repeated measures ANCOVA|||null hypothesis: there will be no difference in the LH and FSH responses to graded doses of GnRH between younger and older postmenopausal women||||<0.03
72327747|NCT01672879|144179796|SUPERIORITY||Difference in LSMeans [SIM - Placebo]|0.1|||||TWO_SIDED|95.0|-1.2|1.5||||||A mixed-effect model for repeated measures (MMRM) with an unstructured variance-covariance matrix for each participant was used to calculate a point estimate and a 95% confidence interval (CI) for the treatment difference between each treatment arm and placebo in least squares mean (LSMean) change from baseline in HVPG at Week 96. With MMRM setting, all participants with available data from 3 treatment groups with change in HVPG at Week 96 contributed to the overall model.||1.5|-1.2|
72327748|NCT01672879|144179796|SUPERIORITY||Difference in LSMeans [SIM - Placebo]|0.1|||||TWO_SIDED|95.0|-1.2|1.4||||||An MMRM with an unstructured variance-covariance matrix for each participant was used to calculate a point estimate and a 95% CI for the treatment difference between each treatment arm and placebo in LSMean change from baseline in HVPG at Week 96. With MMRM setting, all participants with available data from 3 treatment groups with change in HVPG at Week 96 contributed to the overall model.||1.4|-1.2|
72420178|NCT00386022|144351813|EQUIVALENCE|null hypothesis will be accepted if there is no difference in the FSH response to GnRH as a function of dose in younger or older postmenopausal women|||||<|0.001||||||FSH % change with dose|Repeated measures ANCOVA|||||||<0.001
72420179|NCT00386022|144351813|EQUIVALENCE|null hypothesis will be accepted if there is no difference in the FSH response to GnRH between young and old postmenopausal women|||||<|0.005||||||FSH % change with age|Repeated measures ANCOVA|||||||<0.005
72420180|NCT00386022|144351814|EQUIVALENCE|null hypothesis will be accepted if there is no effect of estrogen on the LH response to GnRH in younger and older postmenopausal women|||||<|0.01||||||LH amplitude response with estrogen|Repeated measured ANCOVA|||||||<0.01
72420181|NCT00386022|144351814|EQUIVALENCE|The null hypothesis will be accepted if there is no effect of estrogen on the FSH response to GnRH in younger and older postmenopausal women|||||<|0.0001||||||FSH amplitude response with estrogen|Repeated measures ANCOVA|||||||<0.0001
72420182|NCT00386022|144351814|EQUIVALENCE|The null hypothesis will be accepted if there is no effect of age on the effect of estrogen on the FSH response to GnRH|||||<|0.02||||||FSH amplitude response to estrogen with age|Repeated measures ANCOVA|||||||<0.02
72420183|NCT00386022|144351814|EQUIVALENCE|The null hypothesis will be accepted if there is no effect of age on the effect of estrogen on the LH response to GnRH|||||=|0.4||||||LH amplitude response to estrogen with age|Repeated measures ANCOVA|||||||=0.4
72420184|NCT01542957|144351846|SUPERIORITY_OR_OTHER||Slope|-0.96|STANDARD_ERROR_OF_MEAN|0.69||0.6|TWO_SIDED|95.0|-3.35|1.43|||Mixed Models Analysis|||||1.43|-3.35|0.60
72420185|NCT01542957|144351847|SUPERIORITY_OR_OTHER||Slope|1.27|STANDARD_ERROR_OF_MEAN|0.53||0.21|TWO_SIDED|95.0|-0.71|3.25|||Mixed Models Analysis|||||3.25|-0.71|0.21
72420186|NCT01542957|144351848|SUPERIORITY_OR_OTHER||Slope|-0.01||||0.84|TWO_SIDED|95.0|-0.14|0.12|||Mixed Models Analysis|||||0.12|-0.14|0.84
72420187|NCT00394355|144351869|SUPERIORITY_OR_OTHER_LEGACY|||||||0.261|||||||ANOVA|||"Least squares mean percent changes were obtained from the two-way analysis of variance (ANOVA) model with treatment and BMD scan center effects. Results shown use percent change as a response.~Pooled Standard deviation from the ANOVA model with treatment effects."||||0.261
72420188|NCT00394355|144351869|SUPERIORITY_OR_OTHER_LEGACY|||||||0.644|||||||ANOVA|||"Least squares mean percent changes were obtained from the two-way ANOVA model with treatment and BMD scan center effects. Results shown use percent change as a response.~Pooled Standard deviation from the ANOVA model with treatment effects."||||0.644
72420189|NCT00394355|144351870|SUPERIORITY_OR_OTHER_LEGACY|||||||0.359|||||||ANOVA|||"Least squares mean percent changes were obtained from the two-way ANOVA model with treatment and BMD scan center effects. Results shown use percent change as a response.~Pooled Standard deviation from the ANOVA model with treatment effects."||||0.359
72420190|NCT00394355|144351870|SUPERIORITY_OR_OTHER_LEGACY|||||||0.39|||||||ANOVA|||"Least squares mean percent changes were obtained from the two-way ANOVA model with treatment and BMD scan center effects. Results shown use percent change as a response.~Pooled Standard deviation from the ANOVA model with treatment effects."||||0.390
72420191|NCT00394355|144351871|SUPERIORITY_OR_OTHER_LEGACY|||||||0.169|||||||ANOVA|||"Least squares mean percent changes were obtained from the two-way ANOVA model with treatment and BMD scan center effects. Results shown use percent change as a response.~Pooled Standard deviation from the ANOVA model with treatment effects."||||0.169
72327749|NCT01672879|144179797|SUPERIORITY|||||||0.41|||||||Stratified log-rank test|||Differences in EFS between a given SIM group and placebo were assessed using the log-rank test stratified by HVPG category (\< 10 mmHg vs ≥ 10 mmHg) and presence or absence of diabetes at baseline.||||0.41
72327750|NCT01672879|144179797|SUPERIORITY|||||||0.065|||||||Stratified log-rank test|||Differences in EFS between a given SIM group and placebo were assessed using the log-rank test stratified by HVPG category (\< 10 mmHg vs ≥ 10 mmHg) and presence or absence of diabetes at baseline.||||0.065
72327751|NCT02626156|144179837|SUPERIORITY||Risk Difference (RD)|0.13|STANDARD_ERROR_OF_MEAN|0.07||0.091|TWO_SIDED|95.0|-0.02|0.3|||Chi-squared||Asymptotic standard error was used|||0.3|-0.02|0.091
72327752|NCT03083665|144179860|SUPERIORITY||Percent reduction over Placebo|24.5||||0.0005|TWO_SIDED|95.0|11.7|35.5||Statistical testing with control of Type I error rate were based on a Hochberg multiple comparison procedure.|ANCOVA||Based on ANCOVA with log-transformed \[log(x+1)\] Treatment Period 28-day adjusted partial seizure frequency.|||35.5|11.7|0.0005
72327753|NCT03083665|144179860|SUPERIORITY||Percent reduction over Placebo|33.4|||<|0.0001|TWO_SIDED|95.0|21.9|43.1||Statistical testing with control of Type I error rate were based on a Hochberg multiple comparison procedure.|ANCOVA||Based on ANCOVA with log-transformed \[log(x+1)\] Treatment Period 28-day adjusted partial seizure frequency.|||43.1|21.9|<0.0001
72327754|NCT01467466|144179870|SUPERIORITY||Odds Ratio (OR)|0.95||||0.7|TWO_SIDED|95.0|0.73|1.24|||Wald's Chi-Square|||||1.24|0.73|0.70
72327755|NCT01467466|144179871|SUPERIORITY||Odds Ratio (OR)|1.02||||0.86|TWO_SIDED|95.0|0.78|1.34|||Wald's Chi-Square|||||1.34|0.78|0.86
72327756|NCT01144416|144179881|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The pre-defined non-inferiority margin was -8%|Difference in percentage vital pregnancy|-3.0|||||TWO_SIDED|95.0|-7.4|1.4|||generalized linear model|The estimated difference in percentage vital pregnancy was adjusted for age class as stratified (≤38 yrs vs. \>38 yrs)||||1.4|-7.4|
72420192|NCT00394355|144351871|SUPERIORITY_OR_OTHER_LEGACY|||||||0.526|||||||ANOVA|||"Least squares mean percent changes were obtained from the two-way ANOVA model with treatment and BMD scan center effects. Results shown use percent change as a response.~Pooled Standard deviation from the ANOVA model with treatment effects."||||0.526
72420193|NCT00394355|144351872|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||ANOVA|||Least square means and Pstd (pooled standard deviations) are obtained from the ANOVA model with treatment effects.||||<0.001
72327757|NCT01144416|144179882|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The pre-defined non-inferiority margin was -3 oocytes.|Mean Difference (Final Values)|0.5|||||TWO_SIDED|95.0|-0.2|1.2|||ANOVA|The estimated difference in number of oocytes retrieved was adjusted for age class as stratified (≤38 yrs vs. \>38 yrs) and center.||||1.2|-0.2|
72327758|NCT01144416|144179883|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The pre-defined non-inferiority margin was -8%|Difference in Live Birth Rates|-2.3|||||TWO_SIDED|95.0|-6.5|1.9|||generalized linear model|The estimated difference in live birth rate was adjusted for age class as stratified (≤38 yrs vs. \>38 yrs)||||1.9|-6.5|
72327759|NCT01144416|144179884|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3||95.0|||||Fisher Exact|||||||0.30
72327760|NCT01144416|144179885|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.999||95.0|||||Fisher Exact|||||||>0.999
72327761|NCT03328832|144179886|EQUIVALENCE|equivalence means p value \> 0.05||||||0.276|||||||t-test, 2 sided|||||||0.276
72327762|NCT03328832|144179887|EQUIVALENCE|equivalence means p value \> 0.05||||||1|||||||Wilcoxon (Mann-Whitney)|||||||1
72327763|NCT03328832|144179888|EQUIVALENCE|Equivalence means p value \> 0.05||||||1|||||||Wilcoxon (Mann-Whitney)|||||||1
72327764|NCT00132301|144179889|SUPERIORITY||Hazard Ratio (HR)|0.8||||0.4|TWO_SIDED|95.0|0.58|1.11||Log rank test stratified by site.|Log Rank|||||1.11|0.58|0.40
72327765|NCT02720523|144179890|SUPERIORITY||Response Rate Difference|32.7|||<|0.001|TWO_SIDED|95.0|14.3|51.0|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratification factor prior bDMARD use.|Response Rate Difference = Upadacitinib - Placebo|||51.0|14.3|<0.001
72327766|NCT02720523|144179890|SUPERIORITY||Response Rate Difference|40.8|||<|0.001|TWO_SIDED|95.0|23.5|58.1|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratification factor prior bDMARD use.|Response Rate Difference = Upadacitinib - Placebo|||58.1|23.5|<0.001
72327767|NCT02720523|144179890|SUPERIORITY||Response Rate Difference|37.1|||<|0.001|TWO_SIDED|95.0|19.4|54.9|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratification factor prior bDMARD use.|Response Rate Difference = Upadacitinib - Placebo|||54.9|19.4|<0.001
72327768|NCT02720523|144179890|OTHER|Cochran-Armitage test was conducted for demonstrating a dose response relationship.|||||<|0.001|||||||Cochran-Armitage test|||||||<0.001
72327769|NCT02720523|144179891|SUPERIORITY||Least Squares (LS) Mean Difference|-1.29|||<|0.001|TWO_SIDED|95.0|-1.693|-0.88|||ANCOVA|ANCOVA model including treatment as the fixed factor, and baseline value and the stratification factor prior bDMARD use as covariates.|Difference = Upadacitinib - Placebo|||-0.880|-1.693|<0.001
72327770|NCT02720523|144179891|SUPERIORITY||LS Mean Difference|-1.6|||<|0.001|TWO_SIDED|95.0|-2.005|-1.19|||ANCOVA|ANCOVA model including treatment as the fixed factor, and baseline value and the stratification factor prior bDMARD use as covariates.|Difference = Upadacitinib - Placebo|||-1.190|-2.005|<0.001
72420194|NCT00394355|144351872|SUPERIORITY_OR_OTHER_LEGACY|||||||0.023|||||||ANOVA|||Least square means and Pstd (pooled standard deviations) are obtained from the ANOVA model with treatment effects.||||0.023
72420195|NCT01648348|144351875|SUPERIORITY||Hazard Ratio (HR)|1.14||||0.57|TWO_SIDED|95.0|0.73|1.77|||Log Rank|||||1.77|0.73|0.57
72420196|NCT01648348|144351876|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||<0.001
72327771|NCT02720523|144179891|SUPERIORITY||LS Mean Difference|-1.62|||<|0.001|TWO_SIDED|95.0|-2.027|-1.216|||ANCOVA|ANCOVA model including treatment as the fixed factor, and baseline value and the stratification factor prior bDMARD use as covariates.|Difference = Upadacitinib - Placebo|||-1.216|-2.027|<0.001
72327772|NCT02720523|144179892|SUPERIORITY||LS Mean Difference|-0.3|||<|0.001|TWO_SIDED|95.0|-0.465|-0.144|||ANCOVA|ANCOVA model includes treatment as the fixed factor, and the baseline value and stratification factor prior bDMARD use as the covariates.|Difference = Upadacitinib - Placebo|||-0.144|-0.465|<0.001
72327773|NCT02720523|144179892|SUPERIORITY||LS Mean Difference|-0.34|||<|0.001|TWO_SIDED|95.0|-0.505|-0.184|||ANCOVA|ANCOVA model includes treatment as the fixed factor, and the baseline value and stratification factor prior bDMARD use as the covariates.|Difference = Upadacitinib - Placebo|||-0.184|-0.505|<0.001
72327774|NCT02720523|144179892|SUPERIORITY||LS Mean Difference|-0.39|||<|0.001|TWO_SIDED|95.0|-0.55|-0.229|||ANCOVA|ANCOVA model includes treatment as the fixed factor, and the baseline value and stratification factor prior bDMARD use as the covariates.|Difference = Upadacitinib - Placebo|||-0.229|-0.550|<0.001
72327775|NCT02720523|144179893|SUPERIORITY||Response Rate Difference|24.5||||0.007|TWO_SIDED|95.0|7.3|41.7|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratification factor prior bDMARD use.|Response Rate Difference = Upadacitinib - Placebo|||41.7|7.3|0.007
72327776|NCT02720523|144179893|SUPERIORITY||Response Rate Difference|49.0|||<|0.001|TWO_SIDED|95.0|32.1|65.9|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratification factor prior bDMARD use.|Response Rate Difference = Upadacitinib - Placebo|||65.9|32.1|<0.001
72327777|NCT02720523|144179893|SUPERIORITY||Response Rate Difference|41.7|||<|0.001|TWO_SIDED|95.0|24.5|58.8|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratification factor prior bDMARD use.|Response Rate Difference = Upadacitinib - Placebo|||58.8|24.5|<0.001
72327778|NCT02720523|144179894|SUPERIORITY||Response Rate Difference|18.4||||0.004|TWO_SIDED|95.0|6.4|30.3|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratification factor prior bDMARD use.|Response Rate Difference = Upadacitinib - Placebo|||30.3|6.4|0.004
72327779|NCT02720523|144179894|SUPERIORITY||Response Rate Difference|32.7|||<|0.001|TWO_SIDED|95.0|18.7|46.6|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratification factor prior bDMARD use.|Response Rate Difference = Upadacitinib - Placebo|||46.6|18.7|<0.001
72327780|NCT02720523|144179894|SUPERIORITY||Response Rate Difference|26.0|||<|0.001|TWO_SIDED|95.0|12.9|39.0|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratification factor prior bDMARD use.|Response Rate Difference = Upadacitinib - Placebo|||39.0|12.9|<0.001
72327781|NCT02720523|144179895|SUPERIORITY||LS Mean Difference|4.33|||<|0.001|TWO_SIDED|95.0|2.1|6.57|||Mixed Effect Model Repeat Measurement|MMRM model with fixed effects of treatment, visit and treatment-by-visit interaction, prior bDMARD use, and baseline value as covariate.|Difference = Upadacitinib - Placebo|||6.57|2.10|<0.001
72327782|NCT02720523|144179895|SUPERIORITY||LS Mean Difference|3.5||||0.002|TWO_SIDED|95.0|1.25|5.75|||Mixed Effect Model Repeat Measurement|MMRM model with fixed effects of treatment, visit and treatment-by-visit interaction, prior bDMARD use, and baseline value as covariate.|Difference = Upadacitinib - Placebo|||5.75|1.25|0.002
72420197|NCT01648348|144351877|SUPERIORITY||Hazard Ratio (HR)|1.06||||0.82|TWO_SIDED|95.0|0.66|1.69|||Log Rank|||||1.69|0.66|0.82
72420198|NCT01648348|144351879|SUPERIORITY|||||||0.19|||||||t-test, 2 sided|||||||0.19
72327783|NCT02720523|144179895|SUPERIORITY||LS Mean Difference|5.93|||<|0.001|TWO_SIDED|95.0|3.64|8.22|||Mixed Effect Model Repeat Measurement|MMRM model with fixed effects of treatment, visit and treatment-by-visit interaction, prior bDMARD use, and baseline value as covariate.|Difference = Upadacitinib - Placebo|||8.22|3.64|<0.001
72327784|NCT02720523|144179896|SUPERIORITY||Response Rate Difference|34.7|||<|0.001|TWO_SIDED|95.0|17.0|52.4|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratification factor prior bDMARD use.|Response Rate Difference = Upadacitinib - Placebo|||52.4|17.0|<0.001
72327785|NCT02720523|144179896|SUPERIORITY||Response Rate Difference|51.0|||<|0.001|TWO_SIDED|95.0|34.2|67.9|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratification factor prior bDMARD use.|Response Rate Difference = Upadacitinib - Placebo|||67.9|34.2|<0.001
72327786|NCT02720523|144179896|SUPERIORITY||Response Rate Difference|53.6|||<|0.001|TWO_SIDED|95.0|37.1|70.1|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratification factor prior bDMARD use.|Response Rate Difference = Upadacitinib - Placebo|||70.1|37.1|<0.001
72327787|NCT02720523|144179897|SUPERIORITY||Response Rate Difference|30.6|||<|0.001|TWO_SIDED|95.0|15.5|45.7|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratification factor prior bDMARD use.|Response Rate Difference = Upadacitinib - Placebo|||45.7|15.5|<0.001
72327788|NCT02720523|144179897|SUPERIORITY||Response Rate Difference|51.0|||<|0.001|TWO_SIDED|95.0|35.6|66.4|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratification factor prior bDMARD use.|Response Rate Difference = Upadacitinib - Placebo|||66.4|35.6|<0.001
72327789|NCT02720523|144179897|SUPERIORITY||Response Rate Difference|43.9|||<|0.001|TWO_SIDED|95.0|28.5|59.3|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratification factor prior bDMARD use.|Response Rate Difference = Upadacitinib - Placebo|||59.3|28.5|<0.001
72327790|NCT02720523|144179898|SUPERIORITY||Response Rate Difference|22.4||||0.006|TWO_SIDED|95.0|7.4|37.5|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratification factor prior bDMARD use.|Response Rate Difference = Upadacitinib - Placebo|||37.5|7.4|0.006
72327791|NCT02720523|144179898|SUPERIORITY||Response Rate Difference|16.3||||0.026|TWO_SIDED|95.0|2.1|30.6|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratification factor prior bDMARD use.|Response Rate Difference = Upadacitinib - Placebo|||30.6|2.1|0.026
72420199|NCT01648348|144351880|SUPERIORITY|||||||0.55|||||||t-test, 2 sided|||Future uncertainty symptom scale/item t-test, 2-sided, unpooled.||||0.55
72420200|NCT01648348|144351880|SUPERIORITY|||||||0.16|||||||t-test, 2 sided|||Visual disorder symptom scale/item t-test, 2-sided, unpooled.||||0.16
72420201|NCT01648348|144351880|SUPERIORITY|||||||0.99|||||||t-test, 2 sided|||Motor dysfunction symptom scale/item t-test, 2-sided, unpooled.||||0.99
72327792|NCT02720523|144179898|SUPERIORITY||Response Rate Difference|25.8||||0.002|TWO_SIDED|95.0|10.6|41.0|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratification factor prior bDMARD use.|Response Rate Difference = Upadacitinib - Placebo|||41.0|10.6|0.002
72327793|NCT02720523|144179899|SUPERIORITY||LS Mean Difference|2.66||||0.04|TWO_SIDED|95.0|0.12|5.2|||Mixed Effect Model Repeat Measurement|MMRM model with fixed effects of treatment, visit and treatment-by-visit interaction, prior bDMARD use, and baseline value as covariate.|Difference = Upadacitinib - Placebo|||5.20|0.12|0.040
72327794|NCT02720523|144179899|SUPERIORITY||LS Mean Difference|1.79||||0.169|TWO_SIDED|95.0|-0.77|4.35|||Mixed Effect Model Repeat Measurement|MMRM model with fixed effects of treatment, visit and treatment-by-visit interaction, prior bDMARD use, and baseline value as covariate.|Difference = Upadacitinib - Placebo|||4.35|-0.77|0.169
72420202|NCT01648348|144351880|SUPERIORITY|||||||0.75|||||||t-test, 2 sided|||Communication deficit symptom scale/item t-test, 2-sided, unpooled.||||0.75
72327795|NCT02720523|144179899|SUPERIORITY||LS Mean Difference|0.85||||0.516|TWO_SIDED|95.0|-1.73|3.43|||Mixed Effect Model Repeat Measurement|MMRM model with fixed effects of treatment, visit and treatment-by-visit interaction, prior bDMARD use, and baseline value as covariate.|Difference = Upadacitinib - Placebo|||3.43|-1.73|0.516
72327796|NCT02720523|144179900|SUPERIORITY||LS Mean Difference|-2.54||||0.021|TWO_SIDED|95.0|-4.68|-0.39|||Mixed Effect Model Repeat Measurement|MMRM model with fixed effects of treatment, visit and treatment-by-visit interaction, prior bDMARD use, and baseline value as covariate.|Difference = Upadacitinib - Placebo|||-0.39|-4.68|0.021
72327797|NCT02720523|144179900|SUPERIORITY||LS Mean Difference|-2.06||||0.08|TWO_SIDED|95.0|-4.36|0.25|||Mixed Effect Model Repeat Measurement|MMRM model with fixed effects of treatment, visit and treatment-by-visit interaction, prior bDMARD use, and baseline value as covariate.|Difference = Upadacitinib - Placebo|||0.25|-4.36|0.080
72327798|NCT02720523|144179900|SUPERIORITY||LS Mean Difference|-1.56||||0.22|TWO_SIDED|95.0|-4.06|0.94|||Mixed Effect Model Repeat Measurement|MMRM model with fixed effects of treatment, visit and treatment-by-visit interaction, prior bDMARD use, and baseline value as covariate.|Difference = Upadacitinib - Placebo|||0.94|-4.06|0.220
72327799|NCT02720523|144179901|SUPERIORITY||LS Mean Difference|-1.81|||<|0.001|TWO_SIDED|95.0|-2.57|-1.04|||Mixed Effect Model Repeat Measurement|MMRM model with fixed effects of treatment, visit and treatment-by-visit interaction, prior bDMARD use, and baseline value as covariate.|Difference = Upadacitinib - Placebo|||-1.04|-2.57|<0.001
72327800|NCT02720523|144179901|SUPERIORITY||LS Mean Difference|-1.82|||<|0.001|TWO_SIDED|95.0|-2.59|-1.05|||Mixed Effect Model Repeat Measurement|MMRM model with fixed effects of treatment, visit and treatment-by-visit interaction, prior bDMARD use, and baseline value as covariate.|Difference = Upadacitinib - Placebo|||-1.05|-2.59|<0.001
72327801|NCT02720523|144179901|SUPERIORITY||LS Mean Difference|-1.96|||<|0.001|TWO_SIDED|95.0|-2.73|-1.18|||Mixed Effect Model Repeat Measurement|MMRM model with fixed effects of treatment, visit and treatment-by-visit interaction, prior bDMARD use, and baseline value as covariate.|Difference = Upadacitinib - Placebo|||-1.18|-2.73|<0.001
72420203|NCT01648348|144351880|SUPERIORITY|||||||0.17|||||||t-test, 2 sided|||Headaches symptom scale/item t-test, 2-sided, unpooled.||||0.17
72420204|NCT01648348|144351880|SUPERIORITY|||||||0.9|||||||t-test, 2 sided|||Seizures symptom scale/item t-test, 2-sided, unpooled.||||0.90
72420205|NCT01648348|144351880|SUPERIORITY|||||||0.82|||||||t-test, 2 sided|||Drowsiness symptom scale/item t-test, 2-sided, unpooled.||||0.82
72420206|NCT01648348|144351880|SUPERIORITY|||||||0.15|||||||t-test, 2 sided|||Itchy skin symptom scale/item t-test, 2-sided, unpooled.||||0.15
72420207|NCT01648348|144351880|SUPERIORITY|||||||0.77|||||||t-test, 2 sided|||Hair loss symptom scale/item t-test, 2-sided, unpooled.||||0.77
72327802|NCT02340169|144179902|OTHER||||||||||||||||||Adrenal suppression rates in the evaluable population were 35% (21 out of 60), 43.3% (13 out of 30) and 20% (2 out of 10) in Cohorts 1, 2 a nd 3, respectively.|||
72327803|NCT00480740|144179907|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority of dexmedetomindine plus sevoflurane compared with the baseline (sevoflurane alone) for any given variable was reached when the difference (steady-state \[dexmedetomidine + sevoflurane\]-baseline \[sevoflurane0\]/baseline \[sevoflurane\]0 and its associated 95% confidence interval (CI) fell completely withing the range of +/-20% indicated by the gray column.||||||0.05||95.0||||The original study design was powered to achieve at least 80% power to detect noninferiority with the two-tailed alpha level set at 0.05 for data with two measurements.|t-test, 2 sided|||||||0.05
72327804|NCT02881775|144179932|SUPERIORITY|||||||0.9994||||||The threshold for significance was P \<.05|ANOVA|"Repeated measures ANOVA with restricted maximum likelihood estimation and Kenward-Roger standard errors.~Degrees of freedom (DF) = 34.1"||Comparison of CAR BL Change (treatment by time)||||.9994
72327805|NCT02881775|144179933|SUPERIORITY|||||||0.9768||||||The threshold for statistical significance was p \< .05|ANOVA|Repeated measures ANOVA with restricted maximum likelihood estimation and Kenward-Roger standard errors. DF = 45||Comparison of MVIC BL Change (treatment by time)||||.9768
72327806|NCT02881775|144179934|SUPERIORITY|||||||0.444||||||threshold for statistical significance is p \< .05|ANOVA|Repeated measures ANOVA with restricted maximum likelihood estimation and Kenward-Roger standard errors. DF = 43.1||Comparison of NPRS BL Change (treatment by time)||||0.4440
72327807|NCT02881775|144179935|SUPERIORITY|||||||0.6608||||||Threshold for statistical significance is P \< .05|ANOVA|Repeated measures ANOVA with restricted maximum likelihood estimation and Kenward-Roger standard errors. DF = 45||PPT BL Change (treatment by time)||||.6608
72327808|NCT02881775|144179936|SUPERIORITY|||||||0.7706||||||Threshold for statistical significance is P \< .05|ANOVA|Repeated measures ANOVA with restricted maximum likelihood estimation and Kenward-Roger standard errors. DF = 45||Comparison of TUG BL Change (treatment by time)||||.7706
72327809|NCT02881775|144179937|SUPERIORITY|||||||0.3665||||||Threshold for statistical significance is P \< .05|ANOVA|Repeated measures ANOVA with restricted maximum likelihood estimation and Kenward-Roger standard errors. DF = 33||Comparison of AMT-MEP BL Change (treatment by time)||||.3665
72420208|NCT01648348|144351880|SUPERIORITY|||||||0.1|||||||t-test, 2 sided|||Weakness of legs symptom scale/item t-test, 2-sided, unpooled.||||0.10
72420209|NCT01648348|144351880|SUPERIORITY|||||||0.65|||||||t-test, 2 sided|||Bladder control symptom scale/item t-test, 2-sided, unpooled.||||0.65
72420210|NCT01648348|144351881|SUPERIORITY|||||||0.83|||||||proportion test|||||||0.83
72420211|NCT01951638|144351885|OTHER||Log-Scale mean difference|0.137|||=|0.8991|TWO_SIDED|90.0|-0.04|0.31|||t-test, 1 sided|||For the primary analysis, the three highest active treatment groups BAY1021189 (2.5mg, 2.5 to 5mg, 2.5 to 10mg) were pooled and compared to the assigned placebo treatment group with a one-sided two-sample t-test. The Hochberg procedure was used to test the two primary end points at study-wise significance level of 5%. Results are reported including 90% confidence intervals (CI) for the difference of means. The difference between the comparison groups is difference of means on the log scale.||0.31|-0.04|= 0.8991
72420212|NCT01951638|144351885|OTHER||Log-Scale mean difference|0.076|||=|0.7194|TWO_SIDED|95.0|-0.18|0.33|||t-test, 1 sided|||Pairwise comparisons to placebo were performed in a hierarchical manner (from BAY1021189 from 2.5 to 10mg dose arm to BAY1021189 1.25mg dose arm). In accordance with the specification in the protocol these secondary analyses are considered exploratory only, since the primary analyses were not significant.||0.33|-0.18|= 0.7194
72327810|NCT02881775|144179938|SUPERIORITY|||||||0.3889||||||Threshold for statistical significance is P \< .05|ANOVA|Repeated measures ANOVA with restricted maximum likelihood estimation and Kenward-Roger standard errors. DF = 33||Comparison of SICI BL Change (treatment by time)||||.3889
72327811|NCT02881775|144179939|SUPERIORITY|||||||0.2192||||||Threshold for statistical significance is P \< .05|ANOVA|Repeated measures ANOVA with restricted maximum likelihood estimation and Kenward-Roger standard errors. DF = 33||Comparison of ICF BL Change (treatment by time)||||.2192
72327812|NCT01061723|144179990|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.0||||0.966|TWO_SIDED|95.0|0.4|2.5||Threshold for significance = 0.05|Cochran-Mantel-Haenszel|||Sarilumab group was compared to placebo group. Analysis was performed using two-sided Cochran-Mantel-Haenszel test. Pairwise comparisons of the response rates between each dose of sarilumab and placebo were derived.||2.5|0.4|0.966
72327813|NCT01061723|144179990|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.4||||0.467|TWO_SIDED|95.0|0.6|3.5||Threshold for significance = 0.05|Cochran-Mantel-Haenszel|||||3.5|0.6|0.467
72327814|NCT01061723|144179990|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.8||||0.559|TWO_SIDED|95.0|0.3|1.9||Threshold for significance = 0.05|Cochran-Mantel-Haenszel|||||1.9|0.3|0.559
72327815|NCT01061723|144179990|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.4||||0.496|TWO_SIDED|95.0|0.6|3.4||Threshold for significance = 0.05|Cochran-Mantel-Haenszel|||||3.4|0.6|0.496
72327816|NCT01061723|144179990|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.8||||0.143|TWO_SIDED|95.0|0.8|4.2||Threshold for significance = 0.05|Cochran-Mantel-Haenszel|||||4.2|0.8|0.143
72327817|NCT02476032|144180010|OTHER|||||||0.05|TWO_SIDED|90.0||||P-values for pairwise group comparisons were adjusted for multiple comparisons using the Tukey method.|t-test, 2 sided|||Within group comparisons: t-tests comparing the mean change to 0 were utilized. P-values less than 0.05 were considered statistically significant. SAS V9.3 (SAS Institute Inc., Cary, NC) was used for analysis. The sample size of 20 participants per group was based on having 90% power to detect a one standard deviation difference between the DO-strip groups and the placebo group means using ANOVA with a 0.05 level of significance.||||0.05
72327818|NCT02476032|144180011|OTHER|||||||0.05|TWO_SIDED|90.0||||P-values for pairwise group comparisons were adjusted for multiple comparisons using the Tukey method.|t-test, 2 sided|||Within group comparisons: t-tests comparing the mean change to 0 were utilized. P-values less than 0.05 were considered statistically significant. SAS V9.3 (SAS Institute Inc., Cary, NC) was used for analysis. The sample size of 20 participants per group was based on having 90% power to detect a one standard deviation difference between the DO-strip groups and the placebo group means using ANOVA with a 0.05 level of significance.||||0.05
72327819|NCT00473889|144180014|SUPERIORITY_OR_OTHER|||||||0.992||95.0||||This is a one sided p-value, which corresponds to the null hypothesis.|Stratified Log Rank|Disease stage and bevacizumab eligibility are the stratification factors in the stratified log rank test.||||||0.992
72327820|NCT00473889|144180015|SUPERIORITY_OR_OTHER|||||||0.862||95.0||||This is a one sided p-value, which corresponds to the null hypothesis.|Finkelstein's Interval Censored Method|Disease stage and bevacizumab eligibility are the stratification factors in the Finkelstein's Interval Censored Method Model.||||||0.862
72327821|NCT00473889|144180016|SUPERIORITY_OR_OTHER|||||||0.899||95.0||||This is a one sided p-value, which corresponds to the null hypothesis.|Stratified Miettinen and Nurminen|Disease stage and bevacizumab eligibility are the stratification factors in the stratified Miettinen and Nurmimen method.||||||0.899
72327822|NCT03783962|144180017|SUPERIORITY|||||||0.003|||||||Mixed Models Analysis|||||||.003
72327823|NCT03783962|144180018|SUPERIORITY|||||||0.97|||||||Mixed Models Analysis|||||||.97
72327824|NCT03783962|144180019|SUPERIORITY|||||||0.08|||||||Mixed Models Analysis|||||||.08
72327825|NCT03783962|144180019|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<.001
72327826|NCT03783962|144180019|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<.001
72327827|NCT03783962|144180020|SUPERIORITY|||||||0.18|||||||Mixed Models Analysis|||||||.18
72327828|NCT03783962|144180020|SUPERIORITY|||||||0.4|||||||Mixed Models Analysis|||||||.40
72327829|NCT03783962|144180020|SUPERIORITY|||||||0.01|||||||Mixed Models Analysis|||||||.01
72327830|NCT03783962|144180021|SUPERIORITY|||||||0.4|||||||Mixed Models Analysis|||||||.40
72327831|NCT03783962|144180021|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<.001
72327832|NCT03783962|144180021|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<.001
72327833|NCT03783962|144180022|SUPERIORITY|||||||0.25|||||||Mixed Models Analysis|||||||.25
72327834|NCT03783962|144180022|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<.001
72327835|NCT03783962|144180022|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<.001
72327836|NCT03783962|144180023|SUPERIORITY|||||||0.26|||||||Mixed Models Analysis|||||||.26
72327837|NCT03783962|144180023|SUPERIORITY|||||||0.41|||||||Mixed Models Analysis|||||||.41
72327838|NCT03783962|144180023|SUPERIORITY|||||||0.02|||||||Mixed Models Analysis|||||||.02
72327839|NCT03783962|144180024|SUPERIORITY|||||||0.03|||||||Mixed Models Analysis|||||||.03
72327840|NCT03783962|144180024|SUPERIORITY|||||||0.02|||||||Mixed Models Analysis|||||||.02
72327841|NCT03783962|144180024|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<.001
72327842|NCT03783962|144180025|SUPERIORITY|||||||0.58|||||||Mixed Models Analysis|||||||.58
72327843|NCT03783962|144180025|SUPERIORITY|||||||0.05|||||||Mixed Models Analysis|||||||.05
72327844|NCT03783962|144180025|SUPERIORITY|||||||0.01|||||||Mixed Models Analysis|||||||.01
72327845|NCT03783962|144180026|SUPERIORITY|||||||0.009|||||||Wilcoxon (Mann-Whitney)|||||||.009
72327846|NCT03783962|144180027|SUPERIORITY|||||||0.12|||||||Wilcoxon (Mann-Whitney)|||||||0.12
72327847|NCT03458325|144180028|SUPERIORITY||Mean Difference (Final Values)|-16.0|||<|0.0001|TWO_SIDED|95.0|||||t-test, 2 sided|||"The comparator arm was populated with claims data for patients who presented to the emergency department for worsening HF and were admitted to the hospital for ≤ 72 hours for the treatment of HF. The filter was further strengthened by analyzing diagnostic codes and resource utilization during their hospital stay to exclude hospitalizations other than Heart Failure.~Each subject from the Furoscix group was matched to controls in ratios ranging from 1:1 to 4:1."||-11,802.70|-22,187.90|<0.0001
72327848|NCT03458325|144180029|SUPERIORITY||Percentage Difference|-6.4||||0.6765|TWO_SIDED||||||Fisher Exact|||"The comparator arm was populated with claims data for patients who presented to the emergency department for worsening HF and were admitted to the hospital for ≤ 72 hours for the treatment of HF. The filter was further strengthened by analyzing diagnostic codes and resource utilization during their hospital stay to exclude hospitalizations other than Heart Failure.~Each subject from the Furoscix group was matched to controls in ratios ranging from 1:1 to 4:1."||||0.6765
72327849|NCT03458325|144180030|SUPERIORITY||Mean Difference (Net)|5.3||||0.5856|TWO_SIDED||||||Fisher Exact|||"The comparator arm was populated with claims data for patients who presented to the emergency department for worsening HF and were admitted to the hospital for ≤ 72 hours for the treatment of HF. The filter was further strengthened by analyzing diagnostic codes and resource utilization during their hospital stay to exclude hospitalizations other than Heart Failure.~Each subject from the Furoscix group was matched to controls in ratios ranging from 1:1 to 4:1."||||0.5856
72327850|NCT03458325|144180031|SUPERIORITY||Mean Difference (Net)|-1.9||||1|TWO_SIDED||||||Fisher Exact|||"The comparator arm was populated with claims data for patients who presented to the emergency department for worsening HF and were admitted to the hospital for ≤ 72 hours for the treatment of HF. The filter was further strengthened by analyzing diagnostic codes and resource utilization during their hospital stay to exclude hospitalizations other than Heart Failure.~Each subject from the Furoscix group was matched to controls in ratios ranging from 1:1 to 4:1."||||1.000
72327851|NCT03458325|144180032|SUPERIORITY||Mean Difference (Net)|65.1|||<|0.0001|TWO_SIDED||||||Chi-squared|||"The comparator arm was populated with claims data for patients who presented to the emergency department for worsening HF and were admitted to the hospital for ≤ 72 hours for the treatment of HF. The filter was further strengthened by analyzing diagnostic codes and resource utilization during their hospital stay to exclude hospitalizations other than Heart Failure.~Each subject from the Furoscix group was matched to controls in ratios ranging from 1:1 to 4:1."||||<0.0001
72327852|NCT03458325|144180033|SUPERIORITY||Mean Difference (Net)|12.8||||0.0443|TWO_SIDED|95.0|0.4|25.3|||t-test, 2 sided|P-value was obtained from the paired t-test statistic.||Analysis for Summary Score||25.3|0.4|0.0443
72327853|NCT03458325|144180034|SUPERIORITY|Statistical Analysis for the mean change in NT-proBNP over 30 days|Mean Difference (Final Values)|-122.6||||0.5133|TWO_SIDED|95.0|-525.8|280.5|||t-test, 2 sided|||||280.5|-525.8|0.5133
72327854|NCT03458325|144180034|SUPERIORITY||Mean Difference (Final Values)|-719.9||||0.042|TWO_SIDED|95.0|-1406.5|-33.2|||t-test, 2 sided|||Statistical Analysis for mean change in BNP over 30 days||-33.2|-1406.5|0.0420
72327855|NCT02956746|144180038|OTHER|||||||0.4187||||||threshold for significance p-values \< 0.05|ANOVA|||||||0.4187
72327856|NCT02621476|144180114|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
72327857|NCT01484496|144180115|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.68||||0.0006|TWO_SIDED|95.0|1.25|2.25|||Regression, Logistic|||||2.25|1.25|0.0006
72327858|NCT01484496|144180116|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.51||||0.0004|TWO_SIDED|95.0|0.35|0.74|||Cox proportional hazards model|||||0.74|0.35|0.0004
72327859|NCT01484496|144180117|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.65||||0.0732|TWO_SIDED|95.0|0.95|2.84|||Regression, Logistic|||||2.84|0.95|0.0732
72327860|NCT00131352|144180164|SUPERIORITY_OR_OTHER|||||||0.047||95.0|||||ANCOVA|The repeated measures ANCOVA model included terms for treatment, site, time and time-by-treatment interaction; the baseline score was a covariate.||||||0.047
72327861|NCT00131352|144180165|SUPERIORITY_OR_OTHER|||||||0.064||95.0|||||ANCOVA|||||||0.064
72420213|NCT01951638|144351885|OTHER||Log-Scale mean difference|0.156|||=|0.8653|TWO_SIDED|95.0|-0.12|0.43|||t-test, 1 sided|||Pairwise comparisons to placebo were performed in a hierarchical manner (from BAY1021189 from 2.5 to 10mg dose arm to BAY1021189 1.25mg dose arm). In accordance with the specification in the protocol these secondary analyses are considered exploratory only, since the primary analyses were not significant.||0.43|-0.12|= 0.8653
72327862|NCT00131352|144180166|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.56||||0.022|TWO_SIDED|95.0|0.35|0.92|||Generalized Estimating Equations (GEE)|||Estimate of Odds Ratio (Placebo/Synvisc-One) using WOMAC A1 data at Week 26.||0.92|0.35|0.022
72327863|NCT00131352|144180167|SUPERIORITY_OR_OTHER|||||||0.679||95.0|||||ANCOVA|||||||0.679
72327864|NCT00131352|144180168|SUPERIORITY_OR_OTHER|||||||0.266||95.0|||||ANCOVA|||||||0.266
72327865|NCT00131352|144180169|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.51||||0.005|TWO_SIDED|95.0|0.31|0.82|||Generalized Estimating Equations (GEE)|||Model-based estimate of Odds Ratio (Placebo/Synvisc-One) using PTGA data at Week 26.||0.82|0.31|0.005
72327866|NCT00131352|144180170|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.56||||0.025|TWO_SIDED|95.0|0.34|0.93|||Generalized Estimating Equations (GEE)|||Model-based estimate of Odds Ratio (Placebo/Synvisc-One) using COGA data at Week 26.||0.93|0.34|0.025
72327867|NCT00131352|144180171|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.69||||0.156|TWO_SIDED|95.0|0.41|1.16|||Generalized Estimating Equations (GEE)|||Estimate of Odds Ratio (Placebo/Synvisc-One) using Responder classification data at Week 26.||1.16|0.41|0.156
72327868|NCT02440139|144180172|SUPERIORITY||difference in sensitivity|-0.124|STANDARD_DEVIATION|0.034|<|0.05|TWO_SIDED|95.0|-0.186|-0.062|||Mixed Models Analysis|||||-0.062|-0.186|<0.05
72327869|NCT02440139|144180173|SUPERIORITY||Difference in LROC curves|-0.14|STANDARD_DEVIATION|0.039|<|0.05|TWO_SIDED|95.0|-0.209|-0.071|||ANOVA|||For each study arm, the difference in the least-squares means of the two arms was estimated. A two-sided 95% confidence interval on this difference in study arms (i.e. unaided minus aided by the software) was used to test the hypothesis that the difference in the area under the LROC curve (AUC). The superiority of ClearRead CT will be concluded if the upper bound of the two-sided 95% confidence interval on the difference is less than zero.||-0.071|-0.209|<0.05
72327870|NCT02933879|144180175|SUPERIORITY|||||||0.4615|||||||Z-test, 2 sided|||||||0.4615
72327871|NCT02933879|144180177|SUPERIORITY|||||||0.0404|||||||Z-test, 2 sided|||||||0.0404
72327872|NCT02933879|144180177|SUPERIORITY|||||||0.2106|||||||Z-test, 2 sided|||||||0.2106
72327873|NCT02933879|144180179|SUPERIORITY|||||||1|||||||Z-test, 2 sided|||||||1.0000
72420214|NCT01951638|144351885|OTHER||Log-Scale mean difference|0.171|||=|0.9041|TWO_SIDED|95.0|-0.09|0.43|||t-test, 1 sided|||Pairwise comparisons to placebo were performed in a hierarchical manner (from BAY1021189 from 2.5 to 10mg dose arm to BAY1021189 1.25mg dose arm). In accordance with the specification in the protocol these secondary analyses are considered exploratory only, since the primary analyses were not significant.||0.43|-0.09|= 0.9041
72420215|NCT01951638|144351885|OTHER||Log-Scale mean difference|0.052|||=|0.6572|TWO_SIDED|95.0|-0.2|0.3|||t-test, 1 sided|||Pairwise comparisons to placebo were performed in a hierarchical manner (from BAY1021189 from 2.5 to 10mg dose arm to BAY1021189 1.25mg dose arm). In accordance with the specification in the protocol these secondary analyses are considered exploratory only, since the primary analyses were not significant.||0.3|-0.2|= 0.6572
72327874|NCT02933879|144180181|SUPERIORITY|||||||1|||||||Z-test, 2 sided|||||||1.0000
72327875|NCT02933879|144180184|SUPERIORITY|||||||0.2467|||||||Z-test, 2 sided|||||||0.2467
72327876|NCT00770562|144180221|SUPERIORITY_OR_OTHER|||||||0.004|||||||Fisher Exact|||||||0.004
72420216|NCT01951638|144351886|OTHER||Mean Difference (Net)|1.629|||=|0.8156|TWO_SIDED|90.0|-1.36|4.62|||t-test, 1 sided|||For the primary analysis, the three highest active treatment groups (BAY1021189 2.5mg, BAY1021189 2.5 to 5mg, BAY1021189 2.5 to 10mg) were pooled and compared to the assigned placebo treatment group with a one-sided two-sample t-test. The Hochberg procedure was used to test the two primary end points at study-wise significance level of 5%. Results are reported including 90% confidence intervals (CI) for the difference of means.||4.62|-1.36|= 0.8156
72420217|NCT01951638|144351886|OTHER||Mean Difference (Net)|1.707|||=|0.7945|TWO_SIDED|95.0|-2.39|5.8|||t-test, 1 sided|||Pairwise comparisons to placebo were performed in a hierarchical manner (from BAY1021189 from 2.5 to 10mg dose arm to BAY1021189 1.25mg dose arm). In accordance with the specification in the protocol these secondary analyses are considered exploratory only, since the primary analyses were not significant.||5.8|-2.39|= 0.7945
72420218|NCT01951638|144351886|OTHER||Mean Difference (Net)|2.109|||=|0.7917|TWO_SIDED|95.0|-3.01|7.23|||t-test, 1 sided|||Pairwise comparisons to placebo were performed in a hierarchical manner (from BAY1021189 from 2.5 to 10mg dose arm to BAY1021189 1.25mg dose arm). In accordance with the specification in the protocol these secondary analyses are considered exploratory only, since the primary analyses were not significant.||7.23|-3.01|= 0.7917
72420219|NCT01951638|144351886|OTHER||Mean Difference (Net)|1.219|||=|0.7241|TWO_SIDED|95.0|-2.82|5.26|||t-test, 1 sided|||Pairwise comparisons to placebo were performed in a hierarchical manner (from BAY1021189 from 2.5 to 10mg dose arm to BAY1021189 1.25mg dose arm). In accordance with the specification in the protocol these secondary analyses are considered exploratory only, since the primary analyses were not significant.||5.26|-2.82|= 0.7241
72420220|NCT01951638|144351886|OTHER||Mean Difference (Net)|1.198|||=|0.7546|TWO_SIDED|95.0|-2.23|4.63|||t-test, 1 sided|||Pairwise comparisons to placebo were performed in a hierarchical manner (from BAY1021189 from 2.5 to 10mg dose arm to BAY1021189 1.25mg dose arm). In accordance with the specification in the protocol these secondary analyses are considered exploratory only, since the primary analyses were not significant.||4.63|-2.23|= 0.7546
72420221|NCT01142388|144351924|SUPERIORITY_OR_OTHER_LEGACY|||||||0.85|TWO_SIDED||||||Log Rank|one-sided stratified log rank test, stratifying on: 1) gastroesophageal junction vs. esophagus, 2) squamous cell carcinoma vs. adenocarcinoma.||||||0.85
72420222|NCT01142388|144351925|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5|TWO_SIDED||||||Log Rank|one-sided stratified log rank test, stratifying on 1) gastroesophageal junction vs. esophagus, 2) squamous cell carcinoma vs. adenocarcinoma.||||||0.50
72420223|NCT01787097|144351934|SUPERIORITY|||||||0.003|||||||Wilcoxon (Mann-Whitney)|||||||0.003
72420224|NCT03810534|144351939|SUPERIORITY||Mean Difference (Final Values)|-1.64|STANDARD_ERROR_OF_MEAN|3.24||0.62|TWO_SIDED||||||Mixed Models Analysis||The final estimated mean difference is based on a linear mixed model that adjusts for time and is not equal to the difference in the unadjusted, observed means.|||||.62
72420225|NCT03810534|144351940|SUPERIORITY||Mean Difference (Final Values)|-1.47|STANDARD_ERROR_OF_MEAN|1.44||0.31|TWO_SIDED||||||Mixed Models Analysis||The final estimated mean difference is based on a linear mixed model that adjusts for time and is not equal to the difference in the unadjusted, observed means.|||||.31
72420226|NCT03810534|144351941|SUPERIORITY||Mean Difference (Final Values)|0.03|STANDARD_ERROR_OF_MEAN|0.33||0.93|TWO_SIDED||||||Mixed Models Analysis||The final estimated mean difference is based on a linear mixed model that adjusts for time and is not equal to the difference in the unadjusted, observed means.|||||.93
72420227|NCT03810534|144351942|SUPERIORITY||Mean Difference (Final Values)|0.18|STANDARD_ERROR_OF_MEAN|0.34||0.6|TWO_SIDED||||||Mixed Models Analysis||The final estimated mean difference is based on a linear mixed model that adjusts for time and is not equal to the difference in the unadjusted, observed means.|||||.60
72420228|NCT03810534|144351943|SUPERIORITY||Mean Difference (Final Values)|2.24|STANDARD_ERROR_OF_MEAN|3.49||0.53|TWO_SIDED||||||Mixed Models Analysis||The final estimated mean difference is based on a linear mixed model that adjusts for time and is not equal to the difference in the unadjusted, observed means.|||||.53
72420229|NCT03810534|144351944|SUPERIORITY||Mean Difference (Final Values)|0.78|STANDARD_ERROR_OF_MEAN|3.57||0.83|TWO_SIDED||||||Mixed Models Analysis||The final estimated mean difference is based on a linear mixed model that adjusts for time and is not equal to the difference in the unadjusted, observed means.|||||.83
72420230|NCT03810534|144351945|SUPERIORITY||Mean Difference (Final Values)|0.67|STANDARD_ERROR_OF_MEAN|2.05||0.75|TWO_SIDED||||||Mixed Models Analysis||The final estimated mean difference is based on a linear mixed model that adjusts for time and is not equal to the difference in the unadjusted, observed means.|||||.75
72420231|NCT03810534|144351946|SUPERIORITY||Mean Difference (Final Values)|1.44|STANDARD_ERROR_OF_MEAN|2.07||0.5|TWO_SIDED||||||Mixed Models Analysis||The final estimated mean difference is based on a linear mixed model that adjusts for time and is not equal to the difference in the unadjusted, observed means.|||||.50
72327877|NCT00770562|144180222|SUPERIORITY_OR_OTHER|||||||0.001|||||||Fisher Exact|||||||0.001
72327878|NCT00770562|144180223|SUPERIORITY_OR_OTHER|||||||0.015|||||||Fisher Exact|||||||0.015
72327879|NCT01057693|144180229|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.32||||0.1221|TWO_SIDED|95.0|-0.74|0.09|||ANCOVA|||P-value was calculated using analysis of covariance (ANCOVA), with terms for baseline mean pain score, center and treatment in the model.||0.09|-0.74|0.1221
72327880|NCT00237666|144180256|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||||||<0.0001
72369777|NCT02840799|144249854|SUPERIORITY||Slope|0.01324||||0.3047|TWO_SIDED|95.0|-0.01|0.04||Assuming a 90% retention rate, enrolling 84 subjects in this cross-over trial will have 80% power to detect such an effect size in the intervention induced change of our study endpoints, with a two-sided α=0.05.|Mixed Models Analysis|||||0.04|-0.01|0.3047
72369778|NCT02840799|144249855|SUPERIORITY||Mean Difference (Final Values)|-3.506681|STANDARD_ERROR_OF_MEAN|4.494971||0.44|TWO_SIDED|95.0|-12.598617|5.585256||Assuming a 90% retention rate, enrolling 84 subjects in this cross-over trial will have 80% power to detect such an effect size in the intervention induced change of our study endpoints, with a two-sided α=0.05.|t-test, 2 sided|||||5.585256|-12.598617|0.44
72369779|NCT02840799|144249855|SUPERIORITY||Slope|3.39106||||0.39911|TWO_SIDED|95.0|-4.66|11.44||Assuming a 90% retention rate, enrolling 84 subjects in this cross-over trial will have 80% power to detect such an effect size in the intervention induced change of our study endpoints, with a two-sided α=0.05.|Mixed Models Analysis|||||11.44|-4.66|0.39911
72369780|NCT01621802|144249923|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority criterion for sub cohort 1: Lower limit (LL) of the 2-sided 97.5% confidence interval (CI) for group difference (Inv\_MMR\_CO Group minus pooled Com\_MMR\_CO Group) in seroresponse rates to measles, mumps and rubella viruses is ≥ -5%.|Difference in seroresponse rate (%)|0.0|||||TWO_SIDED|97.5|-0.72|1.98|||||Difference in percentage (Inv\_MMR\_CO Group minus Com\_MMR\_CO Group) in percentage of subjects with an anti-measles antibody concentration ≥ 200 mIU/mL.|"Power obtained using PASS 2005 (Likelihood Score \[Miettienen and Nurminen approach\]), one-sided non-inferiority test for the difference of two independent proportions, under the alternative associated to the reference value \& alpha=1.25%.~The global power to reach all non-inferiority objectives of Priorix vs. M-M-R II in sub-cohort 1 should be at least 94.04% (=100%- the sum of type II errors associated to cohort 1."||1.98|-0.72|
72369781|NCT01621802|144249923|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority criterion for sub cohort 2: The LL of the 2-sided 97.5% CI for group difference (Inv\_MMR\_I group minus pooled Com\_MMR\_I group) in seroresponse rates to measles, mumps and rubella viruses was ≥ -5%.|Difference in Seroresponse rate (%)|0.71|||||TWO_SIDED|97.5|0.02|2.97|||||Difference in percentage (Inv\_MMR\_I Group minus Com\_MMR\_I Group) in percentage of subjects with an anti-Measles antibody concentration ≥ 200 mIU/mL.|"Power obtained using PASS 2005 (Likelihood Score \[Miettienen and Nurminen approach\]), one-sided non-inferiority test for the difference of two independent proportions, under the alternative associated to the reference value \& alpha=1.25%.~The global power to reach all non-inferiority objectives of Priorix vs. M-M-R II in sub-cohort 2 should be at least 98.88% (=100%- the sum of type II error associated to cohort 2."||2.97|0.02|
72369782|NCT01621802|144249924|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority criterion for sub cohort 1: The LL of the 2-sided 97.5% CI for group difference (Inv\_MMR\_CO Group minus pooled Com\_MMR\_CO Group) in seroresponse rates to measles, mumps and rubella viruses was ≥ -5%.|Difference in seroresponse rate (%)|0.0|||||TWO_SIDED|97.5|-0.72|1.97|||||Difference in percentage (Inv\_MMR\_CO Group minus Com\_MMR\_CO Group) in percentage of subjects with an anti-mumps antibody concentration ≥ 10 EU/mL.|"Power obtained using PASS 2005 (Likelihood Score \[Miettienen and Nurminen approach\]), one-sided non-inferiority test for the difference of two independent proportions, under the alternative associated to the reference value \& alpha=1.25%.~The global power to reach all non-inferiority objectives of Priorix vs. M-M-R II in sub-cohort 1 should be at least 94.04% (=100%- the sum of type II errors associated to cohort 1."||1.97|-0.72|
72369783|NCT01621802|144249924|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority criterion for sub cohort 2: The LL of the 2-sided 97.5% CI for group difference (Inv\_MMR\_I group minus pooled Com\_MMR\_I group) in seroresponse rates to measles, mumps and rubella viruses was ≥ -5%.|Difference in Seroresponse rate (%)|0.0|||||TWO_SIDED|97.5|-0.68|1.75|||||Difference in percentage (Inv\_MMR\_I Group minus Com\_MMR\_I Group) in percentage of subjects with an anti-mumps antibody concentration ≥ 10 EU/mL.|"Power obtained using PASS 2005 (Likelihood Score \[Miettienen and Nurminen approach\]), one-sided non-inferiority test for the difference of two independent proportions, under the alternative associated to the reference value \& alpha=1.25%.~The global power to reach all non-inferiority objectives of Priorix vs. M-M-R II in sub-cohort 2 should be at least 98.88% (=100%- the sum of type II error associated to cohort 2."||1.75|-0.68|
72369784|NCT01621802|144249925|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority criterion for sub cohort 1: The LL of the 2-sided 97.5% CI for group difference (Inv\_MMR\_CO group minus pooled Com\_MMR\_CO group) in seroresponse rates to measles, mumps and rubella viruses was ≥ -5%.|Difference in seroresponse rate (%)|-0.14|||||TWO_SIDED|97.5|-0.98|1.84|||||Difference in percentage (Inv\_MMR\_CO Group minus Com\_MMR\_CO Group) in percentage of subjects with an anti-rubella antibody concentration ≥ 10 IU/mL.|"Power obtained using PASS 2005 (Likelihood Score \[Miettienen and Nurminen approach\]), one-sided non-inferiority test for the difference of two independent proportions, under the alternative associated to the reference value \& alpha=1.25%.~The global power to reach all non-inferiority objectives of Priorix vs. M-M-R II in sub-cohort 1 should be at least 94.04% (=100%- the sum of type II errors associated to cohort 1."||1.84|-0.98|
72369785|NCT01621802|144249925|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority criterion for sub cohort 2: The LL of the 2-sided 97.5% CI for group difference (Inv\_MMR\_I group minus pooled Com\_MMR\_I group) in seroresponse rates to measles, mumps and rubella viruses was ≥ -5%.|Difference in seroresponse rate (%)|0.0|||||TWO_SIDED|97.5|-0.68|1.75|||||Difference in percentage (Inv\_MMR\_I Group minus Com\_MMR\_I Group) in percentage of subjects with an anti-rubella antibody concentration ≥ 10 IU/mL.|"Power obtained using PASS 2005 (Likelihood Score \[Miettienen and Nurminen approach\]), one-sided non-inferiority test for the difference of two independent proportions, under the alternative associated to the reference value \& alpha=1.25%.~The global power to reach all non-inferiority objectives of Priorix vs. M-M-R II in sub-cohort 2 should be at least 98.88% (=100%- the sum of type II error associated to cohort 2."||1.75|-0.68|
72369786|NCT01621802|144249926|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority criterion for sub cohort 1: The LL of the 2-sided 97.5% CI for the adjusted GMC ratio (Inv\_MMR\_CO group divided by pooled Com\_MMR\_CO group) was ≥ 0.67 for antibodies to measles, mumps and rubella viruses.|Adjusted GMC ratio|0.99|||||TWO_SIDED|97.5|0.92|1.06|||ANCOVA|Ancova model: adjustment for baseline concentration - pooled variance|The GMCs were used to calculate the Adjusted GMCs, which in turn were used to calculate the Adjusted GMC ratio with 97.5% confidence interval.|||1.06|0.92|
72327881|NCT03951766|144180296|SUPERIORITY||Mean Difference (Final Values)|-1.5|||<|0.0001|TWO_SIDED|95.0|-1.9|-1.1||The a priori threshold for statistical significance was alpha=.05. We did not adjust for multiple comparisons, because this was a secondary outcome. The p-value is for a planned specific comparison of week 6 to baseline.|t-test, 2 sided|||||-1.1|-1.9|<.0001
72327882|NCT03951766|144180297|SUPERIORITY||Median Difference (Final Values)|-24.9|||<|0.0001|TWO_SIDED|95.0|-32.7|-17.1||We used hierarchical linear mixed models with maximum likelihood estimation to handle missing data, then used a planned, pairwise comparison to test for within-person changes between baseline and week 6.|t-test, 2 sided|||||-17.1|-32.7|<.0001
72327883|NCT03951766|144180298|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.06|TWO_SIDED|95.0|0.0|0.4||We used hierarchical linear mixed models with maximum likelihood estimation to handle missing data, then used a planned, pairwise comparison to test for within-person changes between baseline and week 6|t-test, 2 sided|||PANAS positive affect||0.4|-0.0|0.06
72327884|NCT03951766|144180298|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.36|TWO_SIDED|95.0|-0.4|0.1||We used hierarchical linear mixed models with maximum likelihood estimation to handle missing data, then used a planned, pairwise comparison to test for within-person changes between baseline and week 6.|t-test, 2 sided|||PANAS negative affect||0.1|-0.4|0.36
72327885|NCT03951766|144180299|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.1627|TWO_SIDED|95.0|-0.1|0.4||We used hierarchical linear mixed models with maximum likelihood estimation to handle missing data, then used a planned, pairwise comparison to test for within-person changes between baseline and week 6.|t-test, 2 sided|||||0.4|-0.1|0.1627
72327886|NCT03951766|144180300|SUPERIORITY||Mean Difference (Final Values)|1.2||||0.62|TWO_SIDED|95.0|-3.8|6.3||We used hierarchical linear mixed models with maximum likelihood estimation to handle missing data, then used a planned, pairwise comparison to test for within-person changes between baseline and week 6.|t-test, 2 sided|||Single-item - past week||6.3|-3.8|0.62
72327887|NCT03951766|144180300|SUPERIORITY||Mean Difference (Final Values)|-0.5||||0.83|TWO_SIDED|95.0|-5.4|4.4||We used hierarchical linear mixed models with maximum likelihood estimation to handle missing data, then used a planned, pairwise comparison to test for within-person changes between baseline and week 6.|t-test, 2 sided|||Single-item - right now||4.4|-5.4|0.83
72327888|NCT03951766|144180301|SUPERIORITY||Mean Difference (Final Values)|13.1|||<|0.0001|TWO_SIDED|95.0|7.6|18.7||We used hierarchical linear mixed models with maximum likelihood estimation to handle missing data, then used a planned, pairwise comparison to test for within-person changes between baseline and week 6.|t-test, 2 sided|||SEQ-12 - Internal||18.7|7.6|<.0001
72327889|NCT03951766|144180301|SUPERIORITY||Mean Difference (Final Values)|11.1|||<|0.0001|TWO_SIDED|95.0|6.1|16.1|||t-test, 2 sided|||SEQ-12 - External||16.1|6.1|<.0001
72327890|NCT03951766|144180302|SUPERIORITY||Mean Difference (Final Values)|5.5||||0.0126|TWO_SIDED|95.0|1.2|9.8||We used hierarchical linear mixed models with maximum likelihood estimation to handle missing data, then used a planned, pairwise comparison to test for within-person changes between baseline and week 6.|t-test, 2 sided|||||9.8|1.2|0.0126
72327891|NCT03951766|144180303|SUPERIORITY||Mean Difference (Final Values)|-6.6||||0.0053|TWO_SIDED|95.0|-11.1|-2.0||We used hierarchical linear mixed models with maximum likelihood estimation to handle missing data, then used a planned, pairwise comparison to test for within-person changes between baseline and week 6.|t-test, 2 sided|||||-2.0|-11.1|0.0053
72327892|NCT03951766|144180304|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.76|TWO_SIDED|95.0|-0.1|0.2||We used hierarchical linear mixed models with maximum likelihood estimation to handle missing data, then used a planned, pairwise comparison to test for within-person changes between baseline and week 6.|t-test, 2 sided|||ATS - Adverse Effects||0.2|-0.1|0.76
72327893|NCT03951766|144180304|SUPERIORITY||Mean Difference (Final Values)|-0.8|||<|0.0001|TWO_SIDED|95.0|-1.0|-0.5||The a priori threshold for statistical significance was alpha=.05. We did not adjust for multiple comparisons, because this was a secondary outcome. The p-value is for a planned specific comparison of week 6 to baseline.|t-test, 2 sided|||ATS - Psychoactive Benefits||-0.5|-1.0|<.0001
72327894|NCT03951766|144180304|SUPERIORITY||Mean Difference (Final Values)|-0.6|||<|0.0001|TWO_SIDED|95.0|-0.8|-0.3||The a priori threshold for statistical significance was alpha=.05. We did not adjust for multiple comparisons, because this was a secondary outcome. The p-value is for a planned specific comparison of week 6 to baseline.|t-test, 2 sided|||ATS - Pleasure||-0.3|-0.8|<.0001
72327895|NCT03951766|144180305|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.25|TWO_SIDED|95.0|-0.3|0.1||We used hierarchical linear mixed models with maximum likelihood estimation to handle missing data, then used a planned, pairwise comparison to test for within-person changes between baseline and week 6.|t-test, 2 sided|||||0.1|-0.3|0.25
72327896|NCT03951766|144180306|SUPERIORITY|DBI - Positive Experiences|Mean Difference (Final Values)|-20.7|||<|0.0001|TWO_SIDED|95.0|-27.2|-14.3||We used hierarchical linear mixed models with maximum likelihood estimation to handle missing data, then used a planned, pairwise comparison to test for within-person changes between baseline and week 6.|t-test, 2 sided|||||-14.3|-27.2|<.0001
72327897|NCT03951766|144180306|SUPERIORITY|DBI - Negative Experiences|Mean Difference (Final Values)|-2.9||||0.27|TWO_SIDED|95.0|-8.1|2.3||"We used hierarchical linear mixed models with maximum likelihood estimation to handle missing data, then used a planned, pairwise comparison to test for within-person changes between baseline and week 6."|t-test, 2 sided|||||2.3|-8.1|0.27
72327898|NCT03951766|144180307|SUPERIORITY|Pros of Being Smoke-Free|Mean Difference (Final Values)|-9.1||||0.009|TWO_SIDED|95.0|-15.9|-2.3||We used hierarchical linear mixed models with maximum likelihood estimation to handle missing data, then used a planned, pairwise comparison to test for within-person changes between baseline and week 6.|t-test, 2 sided|||||-2.3|-15.9|0.009
72327899|NCT03951766|144180307|SUPERIORITY|Cons of Quitting|Mean Difference (Final Values)|-5.1||||0.25|TWO_SIDED|95.0|-13.7|3.6||We used hierarchical linear mixed models with maximum likelihood estimation to handle missing data, then used a planned, pairwise comparison to test for within-person changes between baseline and week 6.|t-test, 2 sided|||||3.6|-13.7|0.25
72327900|NCT03951766|144180308|SUPERIORITY|PSS total scores|Mean Difference (Final Values)|-2.4||||0.0069|TWO_SIDED|95.0|-4.1|-0.7||We used hierarchical linear mixed models with maximum likelihood estimation to handle missing data, then used a planned, pairwise comparison to test for within-person changes between baseline and week 6.|t-test, 2 sided|||||-0.7|-4.1|0.0069
72420232|NCT03810534|144351947|SUPERIORITY||Mean Difference (Final Values)|0.36|STANDARD_ERROR_OF_MEAN|0.5||0.48|TWO_SIDED||||||Mixed Models Analysis||The final estimated mean difference is based on a linear mixed model that adjusts for time and is not equal to the difference in the unadjusted, observed means.|||||.48
72327901|NCT03951766|144180308|SUPERIORITY|PSS - Perceived Helplessness|Mean Difference (Final Values)|-0.3||||0.0043|TWO_SIDED|95.0|-0.5|-0.1||We used hierarchical linear mixed models with maximum likelihood estimation to handle missing data, then used a planned, pairwise comparison to test for within-person changes between baseline and week 6.|t-test, 2 sided|||||-0.1|-0.5|0.0043
72327902|NCT03951766|144180308|SUPERIORITY|PSS - Perceived Self-Efficacy|Mean Difference (Final Values)|0.1||||0.1953|TWO_SIDED|95.0|-0.1|0.4||We used hierarchical linear mixed models with maximum likelihood estimation to handle missing data, then used a planned, pairwise comparison to test for within-person changes between baseline and week 6.|t-test, 2 sided|||||0.4|-0.1|0.1953
72327903|NCT03951766|144180309|SUPERIORITY|Brief COPE Self-distraction|Mean Difference (Final Values)|0.4||||0.087|TWO_SIDED|95.0|-0.1|0.8||We used hierarchical linear mixed models with maximum likelihood estimation to handle missing data, then used a planned, pairwise comparison to test for within-person changes between baseline and week 6.|t-test, 2 sided|||||0.8|-0.1|0.087
72327904|NCT03951766|144180309|SUPERIORITY|Brief COPE active coping|Mean Difference (Final Values)|-0.209||||0.2866|TWO_SIDED|95.0|-0.6|0.2||We used hierarchical linear mixed models with maximum likelihood estimation to handle missing data, then used a planned, pairwise comparison to test for within-person changes between baseline and week 6.|t-test, 2 sided|||||0.2|-0.6|0.2866
72327905|NCT03951766|144180309|SUPERIORITY|Brief COPE denial|Mean Difference (Final Values)|0.0||||0.9296|TWO_SIDED|95.0|-0.4|0.4||We used hierarchical linear mixed models with maximum likelihood estimation to handle missing data, then used a planned, pairwise comparison to test for within-person changes between baseline and week 6|t-test, 2 sided|||||0.4|-0.4|0.9296
72327906|NCT03951766|144180309|SUPERIORITY|Brief COPE substance use|Mean Difference (Final Values)|-0.1||||0.6599|TWO_SIDED|95.0|-0.5|0.3||We used hierarchical linear mixed models with maximum likelihood estimation to handle missing data, then used a planned, pairwise comparison to test for within-person changes between baseline and week 6|t-test, 2 sided|||||0.3|-0.5|0.6599
72327907|NCT03951766|144180309|SUPERIORITY|Brief COPE use of emotional support|Mean Difference (Final Values)|0.3||||0.2315|TWO_SIDED|95.0|-0.2|0.7||We used hierarchical linear mixed models with maximum likelihood estimation to handle missing data, then used a planned, pairwise comparison to test for within-person changes between baseline and week 6|t-test, 2 sided|||||0.7|-0.2|0.2315
72327908|NCT03951766|144180309|SUPERIORITY|Brief COPE use of instrumental support|Mean Difference (Final Values)|0.1||||0.6183|TWO_SIDED|95.0|-0.3|0.6||We used hierarchical linear mixed models with maximum likelihood estimation to handle missing data, then used a planned, pairwise comparison to test for within-person changes between baseline and week 6.|t-test, 2 sided|||||0.6|-0.3|0.6183
72327909|NCT03951766|144180309|SUPERIORITY|Brief COPE behavioral disengagement|Mean Difference (Final Values)|0.3||||0.2037|TWO_SIDED|95.0|-0.1|0.7||We used hierarchical linear mixed models with maximum likelihood estimation to handle missing data, then used a planned, pairwise comparison to test for within-person changes between baseline and week 6.|t-test, 2 sided|||||0.7|-0.1|0.2037
72327910|NCT03951766|144180309|SUPERIORITY|Brief COPE venting|Mean Difference (Final Values)|-0.5||||0.006|TWO_SIDED|95.0|-0.9|-0.2||We used hierarchical linear mixed models with maximum likelihood estimation to handle missing data, then used a planned, pairwise comparison to test for within-person changes between baseline and week 6.|t-test, 2 sided|||||-0.2|-0.9|0.0060
72327911|NCT03951766|144180309|SUPERIORITY|Brief COPE positive reframing|Mean Difference (Final Values)|-0.2||||0.3045|TWO_SIDED|95.0|-0.7|0.2||We used hierarchical linear mixed models with maximum likelihood estimation to handle missing data, then used a planned, pairwise comparison to test for within-person changes between baseline and week 6.|t-test, 2 sided|||||0.2|-0.7|0.3045
72327912|NCT03951766|144180309|SUPERIORITY|Brief COPE planning|Mean Difference (Final Values)|-0.6||||0.0029|TWO_SIDED|95.0|-1.0|-0.2||We used hierarchical linear mixed models with maximum likelihood estimation to handle missing data, then used a planned, pairwise comparison to test for within-person changes between baseline and week 6.|t-test, 2 sided|||||-0.2|-1.0|0.0029
72327913|NCT03951766|144180309|SUPERIORITY|Brief COPE humor|Mean Difference (Final Values)|0.0||||0.8274|TWO_SIDED|95.0|-0.5|0.4||We used hierarchical linear mixed models with maximum likelihood estimation to handle missing data, then used a planned, pairwise comparison to test for within-person changes between baseline and week 6.|t-test, 2 sided|||||0.4|-0.5|0.8274
72327914|NCT03951766|144180309|SUPERIORITY|Brief COPE acceptance|Mean Difference (Final Values)|0.4||||0.0349|TWO_SIDED|95.0|0.0|0.9||We used hierarchical linear mixed models with maximum likelihood estimation to handle missing data, then used a planned, pairwise comparison to test for within-person changes between baseline and week 6.|t-test, 2 sided|||||0.9|0.0|0.0349
72327915|NCT03951766|144180309|SUPERIORITY|Brief COPE religion|Mean Difference (Final Values)|0.2||||0.3451|TWO_SIDED|95.0|-0.2|0.6||We used hierarchical linear mixed models with maximum likelihood estimation to handle missing data, then used a planned, pairwise comparison to test for within-person changes between baseline and week 6.|t-test, 2 sided|||||0.6|-0.2|0.3451
72327916|NCT03951766|144180309|SUPERIORITY|Brief COPE self-blame|Mean Difference (Final Values)|-0.8||||0.0006|TWO_SIDED|95.0|-1.2|-0.3||We used hierarchical linear mixed models with maximum likelihood estimation to handle missing data, then used a planned, pairwise comparison to test for within-person changes between baseline and week 6.|t-test, 2 sided|||||-0.3|-1.2|0.0006
72327917|NCT00363142|144180312|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority of FPV/r100 to FPV/r200 would be declared if the lower limit of the 2-sided 95% confidence interval on the difference in percentage of participants not meeting the virologic failure definition \[FPV/r100 minus FPV/r200\] was -12% or greater.|Difference in the percentages|-2.12||||||95.0|-9.36|5.12|||||Difference in percentages = percentage in Arm 1 minus percentage in Arm 2|||5.12|-9.36|
72327918|NCT01926444|144180345|OTHER|||||||0.506|||||||ANOVA|||AUC- censorsed (standardized); FAS||||0.506
72327919|NCT01926444|144180345|OTHER|||||||0.299|||||||ANOVA|||AUC LOCF (standardized); FAS||||0.299
72327920|NCT01926444|144180345|OTHER|||||||0.234|||||||ANOVA|||AUC Censored (Standardized)- PP Population||||0.234
72327921|NCT01926444|144180345|OTHER|||||||0.219|||||||ANOVA|||AUC LOCF (Standardized)- PP Population||||0.219
72327922|NCT01926444|144180346|OTHER|||||||0.047|||||||Chi-squared|||Time to Caecum||||0.047
72327923|NCT01926444|144180347|OTHER|||||||0.047|||||||Chi-squared|||||||0.047
72420233|NCT03810534|144351948|SUPERIORITY||Mean Difference (Final Values)|0.65|STANDARD_ERROR_OF_MEAN|0.52||0.22|TWO_SIDED||||||Mixed Models Analysis||The final estimated mean difference is based on a linear mixed model that adjusts for time and is not equal to the difference in the unadjusted, observed means.|||||.22
72327924|NCT00295646|144180377|SUPERIORITY|A two-sided significance level of 2.5% was used in this 2x2 factorial design of two primary endpoints according to the Bonferroni-Holm adjustment to control multiplicity.|Cox Proportional Hazard|1.1||||0.59|TWO_SIDED|95.0|0.78|1.53||Two-sided significance level of 2.5%, with the application of the Bonferroni-Holm adjustment for multiple comparisons|Log Rank||From the Cox Proportional hazard model with endocrine treatment fitted as a covariate. A hazard ratio \> 1.0 indicates a higher average event rate and a shorter disease-free time for arimidex relative to tamoxifen.|To determine the effect of arimidex (AZ and AC) compared to tamoxifen (TZ and TC) in terms of disease-free survival. Disease-free survival (DFS) is defined as the time from randomization to the first occurrence of a local or regional recurrence, cancer in the contralateral breast, distant metastasis, second primary carcinoma, or death from any cause.||1.53|0.78|0.59
72327925|NCT00295646|144180378|SUPERIORITY|A two-sided significance level of 2.5% was used in this 2x2 factorial design of two primary endpoints according to the Bonferroni-Holm adjustment to control multiplicity.|Cox Proportional Hazard|0.64||||0.01|TWO_SIDED|95.0|0.46|0.91||Two-sided significance level of 2.5%, with the application of the Bonferroni-Holm adjustment for multiple comparisons|Log Rank||From the Cox Proportional hazard model with Zoledronic Acid treatment fitted as a covariate. A hazard ratio \< 1.0 indicates a lower average event rate and a longer disease-free time for Zoledronic Acid relative to no Zoledronic Acid.|To determine the effect of Zoledronic Acid (AZ and TZ) compared to no Zoledronic Acid (AC and TC) in terms of disease-free survival. Disease-free survival (DFS) is defined as the time from randomization to the first occurrence of a local or regional recurrence, cancer in the contralateral breast, distant metastasis, second primary carcinoma, or death from any cause.||0.91|0.46|0.01
72327926|NCT00295646|144180379|SUPERIORITY|No multiplicity adjustment was applied.|Cox Proportional Hazard|1.11||||0.53|TWO_SIDED|95.0|0.8|1.56|||Log Rank||From the Cox Proportional hazard model with endocrine treatment fitted as a covariate. A hazard ratio \> 1.0 indicates a higher average event rate and a shorter recurrence-free time for arimidex relative to tamoxifen.|To determine the effect of arimidex (AZ and AC) compared to tamoxifen (TZ and TC) in terms of recurrence-free survival. Recurrence-free survival is defined as the time from randomization to the first occurrence of a local or regional recurrence, cancer in the contralateral breast, distant metastasis, second primary carcinoma, or death related to breast cancer.||1.56|0.80|0.53
72327927|NCT00295646|144180380|SUPERIORITY|No multiplicity adjustment was applied.|Cox Proportional Hazard|0.65||||0.01|TWO_SIDED|95.0|0.46|0.92|||Log Rank|||To determine the effect of Zoledronic Acid (AZ and TZ) compared to no Zoledronic Acid (AC and TC) in terms of recurrence-free survival. Recurrence-free survival is defined as the time from randomization to the first occurrence of a local or regional recurrence, cancer in the contralateral breast, distant metastasis, second primary carcinoma, or death related to breast cancer.|From the Cox Proportional hazard model with Zoledronic Acid treatment fitted as a covariate. A hazard ratio \< 1.0 indicates a lower average event rate and a longer recurrence-free time for Zoledronic Acid relative to no Zoledronic Acid.|0.92|0.46|0.01
72420234|NCT03810534|144351949|SUPERIORITY||Mean ratio|0.96|STANDARD_ERROR_OF_MEAN|0.25||0.88|TWO_SIDED||||||Mixed Models Analysis|||||||.88
72420235|NCT03810534|144351950|SUPERIORITY||Mean ratio|0.72|STANDARD_ERROR_OF_MEAN|0.18||0.23|TWO_SIDED||||||Mixed Models Analysis|||||||.23
72420236|NCT02293395|144351954|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.09||||0.584|TWO_SIDED|95.0|0.8|1.5|||Log Rank|||||1.5|0.8|0.584
72420237|NCT00944658|144351972|SUPERIORITY|||||||0.139|||||||ANCOVA|||||||0.139
72420238|NCT00944658|144351973|SUPERIORITY|||||||0.58|||||||ANCOVA|||||||0.58
72420239|NCT00944658|144351974|SUPERIORITY|||||||0.108|||||||ANCOVA|Rank Ancova||||||0.108
72420240|NCT00297115|144351986|SUPERIORITY_OR_OTHER||Mean Difference (Net)|58.0|STANDARD_ERROR_OF_MEAN|9.0|<|0.0001|TWO_SIDED|95.0|41.0|75.0||No adjustment of the significance level was done as a hierarchical approach for hypotheses testing was used.|ANCOVA|Repeated measurements analysis (change from baseline over 52 weeks of treatment taking all post-randomization measurements into account).||||75|41|<0.0001
72420241|NCT00297115|144351987|SUPERIORITY_OR_OTHER||Rate ratio|0.815|STANDARD_ERROR_OF_MEAN|0.057||0.0035|TWO_SIDED|95.0|0.71|0.935||No adjustment of the significance level was done as a hierarchical approach for hypotheses testing was used.|Poisson regression|||||0.935|0.710|0.0035
72420242|NCT00297115|144351988|SUPERIORITY_OR_OTHER||Mean Difference (Net)|61.0|STANDARD_ERROR_OF_MEAN|9.0|<|0.0001|TWO_SIDED|95.0|44.0|79.0||No adjustment of the significance level was done as a hierarchical approach for hypotheses testing was used.|ANCOVA|Repeated measurements analysis (change from baseline over 52 weeks of treatment taking all post-randomization measurements into account).||||79|44|<0.0001
72420243|NCT00297115|144351989|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.213|STANDARD_ERROR_OF_MEAN|0.35||0.5028|TWO_SIDED|95.0|0.689|2.137||No adjustment of the significance level was done as a hierarchical approach for hypotheses testing was used.|Cox proportional hazards regression||The statistical analysis is based on the ITT Analysis Set (n= 772 in the roflumilast group, n= 796 in the placebo group).|||2.137|0.689|0.5028
72420244|NCT00297115|144351990|SUPERIORITY_OR_OTHER||Mean Difference calculated as ratio|1.0593||||0.3627|TWO_SIDED|95.0|0.9356|1.1994||No adjustment of the significance level was done as a hierarchical approach for hypotheses testing was used.|ANCOVA|ANCOVA model including last observation carried forward (LOCF) method||||1.1994|0.9356|0.3627
72420245|NCT00297115|144351991|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.286|STANDARD_ERROR_OF_MEAN|0.104||0.0059|TWO_SIDED|95.0|0.082|0.489||No adjustment of the significance level was done as a hierarchical approach for hypotheses testing was used.|ANCOVA|Repeated measurements analysis (change from baseline over 52 weeks of treatment taking all post-randomization measurements into account).||||0.489|0.082|0.0059
72420246|NCT02472652|144352007|OTHER||change in prolactin|30.0|||||TWO_SIDED|||||||||||||
72420247|NCT02713711|144352008|SUPERIORITY|ANOVA. Sample was calculated with power of 80% and alpha of 0.05.||||||0.3262|||||||ANOVA|repeated measures ANOVA (Bonferroni post-test) for intragroup analysis||||||0.3262
72420248|NCT02713711|144352008|SUPERIORITY|ANOVA. Sample was calculated with power of 80% and alpha of 0.05.||||||0.01|||||||ANOVA|repeated measures ANOVA (Bonferroni post-test) for intragroup analysis||||||0.01
72420249|NCT02713711|144352008|SUPERIORITY|ANOVA. Sample was calculated with power of 80% and alpha of 0.05.||||||0.0646|||||||ANOVA|repeated measures ANOVA (Bonferroni post-test) for intragroup analysis||||||0.0646
72420250|NCT02713711|144352008|SUPERIORITY|ANOVA. Sample was calculated with power of 80% and alpha of 0.05.|||||<|0.001|||||||ANOVA|repeated measures ANOVA (Bonferroni post-test) for intragroup analysis||||||<0.001
72420251|NCT02713711|144352008|SUPERIORITY|Two-way ANOVA (Bonferroni post-test) for intergroup analysis.|||||<|0.001|||||||ANOVA|||||||<0.001
72420252|NCT02713711|144352009|SUPERIORITY|paired-t test (intragroup analysis)||||||0.208|||||||t-test, 2 sided|||||||0.2080
72420253|NCT02713711|144352009|SUPERIORITY|paired-t test (intragroup analysis)||||||0.0136|||||||t-test, 2 sided|||||||0.0136
72420254|NCT02713711|144352009|SUPERIORITY|paired-t test (intragroup analysis)||||||0.2987|||||||t-test, 2 sided|||||||0.2987
72420255|NCT02713711|144352009|SUPERIORITY|paired-t test (intragroup analysis)||||||0.8347|||||||t-test, 2 sided|||||||0.8347
72420256|NCT02713711|144352009|SUPERIORITY|two-way ANOVA with Bonferroni post hoc test (intergroup analysis)||||||0.0001|||||||ANOVA|||||||0.0001
72420257|NCT00998400|144352013|SUPERIORITY|||||||0.03|||||||Repeated Measures ANOVA|All analyses were performed by using intention-to-treat (ITT) analysis, where missing values were managed by means of multiple imputations procedure.||||||0.030
72420258|NCT00998400|144352014|SUPERIORITY||||||>|0.05|||||||Repeated Measures ANOVA|All analyses were performed by using intention-to-treat (ITT) analysis, where missing values were managed by means of multiple imputations procedure.||||||>0.05
72420259|NCT00998400|144352015|SUPERIORITY||||||>|0.05|||||||Repeated Measures ANOVA|All analyses were performed by using intention-to-treat (ITT) analysis, where missing values were managed by means of multiple imputations procedure.||||||>0.05
72420260|NCT00998400|144352016|SUPERIORITY||||||>|0.05|||||||Kaplan-Meier Survival analysis|||||||>0.05
72420261|NCT00998400|144352017|SUPERIORITY||||||>|0.05|||||||Repeated Measures ANOVA|All analyses were performed by using intention-to-treat (ITT) analysis, where missing values were managed by means of multiple imputations procedure.||||||>0.05
72420262|NCT00998400|144352018|SUPERIORITY||||||>|0.05|||||||Repeated Measures ANOVA|All analyses were performed by using intention-to-treat (ITT) analysis, where missing values were managed by means of multiple imputations procedure.||||||>0.05
72420263|NCT00998400|144352019|SUPERIORITY|||||||0.013|||||||Repeated Measures ANOVA|All analyses were performed by using intention-to-treat (ITT) analysis, where missing values were managed by means of multiple imputations procedure.||||||0.013
72420264|NCT00998400|144352020|SUPERIORITY||||||>|0.05|||||||Repeated Measures ANOVA|All analyses were performed by using intention-to-treat (ITT) analysis, where missing values were managed by means of multiple imputations procedure.||||||>0.05
72420265|NCT00998400|144352021|SUPERIORITY||||||>|0.05|||||||Repeated Measures ANOVA|All analyses were performed by using intention-to-treat (ITT) analysis, where missing values were managed by means of multiple imputations procedure.||||||>0.05
72420266|NCT00998400|144352022|SUPERIORITY||||||>|0.05|||||||Repeated Measures ANOVA|All analyses were performed by using intention-to-treat (ITT) analysis, where missing values were managed by means of multiple imputations procedure.||||||>0.05
72327928|NCT00295646|144180381|SUPERIORITY|No multiplicity adjustment was applied.|Cox Proportional Hazard|1.8||||0.07|TWO_SIDED|95.0|0.96|3.38|||Log Rank||From the Cox Proportional hazard model with endocrine treatment fitted as a covariate. A hazard ratio \> 1.0 indicates a higher average event rate and a shorter survival time for arimidex relative to tamoxifen.|To determine the effect of anastrozole (AZ and AC) compared to tamoxifen (TZ and TC) in terms of overall survival. Overall survival is defined as the time from randomization to death from any cause.||3.38|0.96|0.07
72327929|NCT00295646|144180382|SUPERIORITY|No multiplicity adjustment was applied.|Cox Proportional Hazard|0.6||||0.1|TWO_SIDED|95.0|0.32|1.11|||Log Rank||From the Cox Proportional hazard model with Zoledronic Acid treatment fitted as a covariate. A hazard ratio \< 1.0 indicates a lower average event rate and a longer survival time for Zoledronic Acid relative to no Zoledronic Acid.|To determine the effect of Zoledronic Acid (AZ and TZ) compared to no Zoledronic Acid (AC and TC) in terms of overall survival. Overall survival is defined as the time from randomization to death from any cause.||1.11|0.32|0.10
72327930|NCT03579693|144180383|SUPERIORITY||Mean Difference (Final Values)|0.44||||0.33|TWO_SIDED|95.0|-0.43|1.31|||Mixed Models Analysis||Interpretation of mean difference is for a typical participant, i.e. random effect of 0.|||1.31|-0.43|0.33
72327931|NCT03579693|144180383|SUPERIORITY||Mean Difference (Final Values)|-0.04||||0.93|TWO_SIDED|95.0|-0.9|0.82|||Mixed Models Analysis||Interpretation of mean difference is for a typical participant, i.e. random effect of 0.|||0.82|-0.90|0.93
72327932|NCT03579693|144180384|SUPERIORITY||Mean Difference (Final Values)|-1.76||||0.05|TWO_SIDED|95.0|-3.47|0.0|||Mixed Models Analysis||Interpretation of mean difference is for a typical participant, i.e. random effect of 0.|||0.00|-3.47|0.050
72327933|NCT03579693|144180384|SUPERIORITY||Mean Difference (Final Values)|-0.62||||0.47|TWO_SIDED|95.0|-2.28|1.05|||Mixed Models Analysis||Interpretation of mean difference is for a typical participant, i.e. random effect of 0.|||1.05|-2.28|0.47
72327934|NCT03541499|144180430|SUPERIORITY|||||||0.807|||||||Barnard's exact test|||At any time point||||0.807
72420267|NCT00998400|144352023|SUPERIORITY||||||>|0.05|||||||Repeated Measures ANOVA|All analyses were performed by using intention-to-treat (ITT) analysis, where missing values were managed by means of multiple imputations procedure.||||||>0.05
72420268|NCT00998400|144352024|SUPERIORITY||||||>|0.05|||||||Repeated Measures ANOVA|All analyses were performed by using intention-to-treat (ITT) analysis, where missing values were managed by means of multiple imputations procedure.||||||>0.05
72420269|NCT01493687|144352043|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
72420270|NCT01493687|144352044|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-8.13|||<|0.001|TWO_SIDED|95.0|-10.12|-6.13|||ANCOVA|||||-6.13|-10.12|<0.001
72420271|NCT01493687|144352045|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
72420272|NCT05067439|144352046|OTHER||Ratio of Adjusted Geometric Means|288.81|||||TWO_SIDED|90.0|240.56|346.73||||||Omeprazole 10 mg was Reference and abrocitinib 200 mg + omeprazole 10 mg was Test. Natural log-transformed AUCinf was analyzed using a mixed effect model with treatment as a fixed effect and participant as a random effect and estimates of the adjusted mean differences (Test-Reference) and 90% CIs were obtained. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CI.||346.73|240.56|
72420273|NCT05067439|144352047|OTHER||Ratio of Adjusted Geometric Means|139.59|||||TWO_SIDED|90.0|121.98|159.74||||||Caffeine 100 mg was Reference and abrocitinib 200 mg + caffeine 100 mg was Test. Natural log-transformed AUCinfCR was analyzed using a mixed effect model with treatment as a fixed effect and participant as a random effect and estimates of the adjusted mean differences (Test-Reference) and 90% CIs were obtained. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CI.||159.74|121.98|
72420274|NCT05067439|144352048|OTHER||Ratio of Adjusted Geometric Means|110.1|||||TWO_SIDED|90.0|103.45|117.17||||||Efavirenz 50 mg was Reference and abrocitinib 200 mg + efavirenz 50 mg was Test. Natural log-transformed AUClastCR was analyzed using a mixed effect model with treatment as a fixed effect and participant as a random effect and estimates of the adjusted mean differences (Test-Reference) and 90% CIs were obtained. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CI.||117.17|103.45|
72327935|NCT03541499|144180430|SUPERIORITY|||||||0.043|||||||Barnard's exact test|||At any time point||||0.043
72327936|NCT03541499|144180431|SUPERIORITY|||||||1|||||||Barnard's exact test|||Any time point||||1.000
72327937|NCT03541499|144180431|SUPERIORITY|||||||0.301|||||||Barnard's exact test|||Any time point||||0.301
72327938|NCT03541499|144180432|SUPERIORITY|||||||1|||||||Barnard's exact test|||Any time point||||1.000
72327939|NCT03541499|144180432|SUPERIORITY|||||||0.009|||||||Barnard's exact test|||Any time point||||0.009
72327940|NCT03541499|144180434|SUPERIORITY|||||||0.526|||||||Barnard's exact test|||IgA, any time point||||0.526
72327941|NCT03541499|144180434|SUPERIORITY|||||||0.1|||||||Barnard's exact test|||IgA, any time point||||0.100
72327942|NCT03541499|144180434|SUPERIORITY|||||||0.055|||||||Barnard's exact test|||IgG, any time point||||0.055
72327943|NCT03541499|144180434|SUPERIORITY|||||||0.023|||||||Barnard's exact test|||IgG, any time point||||0.023
72327944|NCT03541499|144180435|SUPERIORITY|||||||0.174|||||||Barnard's exact test|||IgA, any time point||||0.174
72327945|NCT03541499|144180435|SUPERIORITY|||||||0.006|||||||Barnard's exact test|||IgA, any time point||||0.006
72327946|NCT03541499|144180435|SUPERIORITY|||||||0.745|||||||Barnard's exact test|||IgG, any time point||||0.745
72327947|NCT03541499|144180435|SUPERIORITY|||||||0.023|||||||Barnard's exact test|||IgG, any time point||||0.023
72327948|NCT03541499|144180441|SUPERIORITY|||||||0.023|||||||Barnard's exact test|||IgA, any time point||||0.023
72327949|NCT03541499|144180441|SUPERIORITY|||||||0.142|||||||Barnard's exact test|||IgA, any time point||||0.142
72327950|NCT03541499|144180441|SUPERIORITY|||||||0.526|||||||Barnard's exact test|||IgG, any time point||||0.526
72420275|NCT02323646|144352063|SUPERIORITY|||||||0.0019|||||||Fisher Exact|||||||0.0019
72420276|NCT02323646|144352063|SUPERIORITY|||||||0.0063|||||||Fisher Exact|||||||0.0063
72420277|NCT02323646|144352064|SUPERIORITY|||||||0.0237|||||||Fisher Exact|||||||0.0237
72420278|NCT02323646|144352064|SUPERIORITY|||||||0.0272|||||||Fisher Exact|||||||0.0272
72420279|NCT02323646|144352065|SUPERIORITY|||||||0.0145|||||||Wilcoxon Rank-Sum Test.|||Percentage change in the last value on drug Course 1.||||0.0145
72420280|NCT02323646|144352065|SUPERIORITY|||||||0.0662|||||||Wilcoxon Rank-Sum Test.|||Percentage change in the last value on drug Course 1.||||0.0662
72420281|NCT02323646|144352065|SUPERIORITY|||||||0.0061|||||||Wilcoxon Rank-Sum Test|||Percentage change in the last value on drug Course 2.||||0.0061
72420282|NCT02323646|144352065|SUPERIORITY|||||||0.0296|||||||Wilcoxon Rank-Sum Test|||Percentage change in the last value on drug Course 2.||||0.0296
72420283|NCT02323646|144352066|SUPERIORITY|||||||0.2642|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 1||||0.2642
72420284|NCT02323646|144352066|SUPERIORITY|||||||0.4383|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 1||||0.4383
72420285|NCT02323646|144352066|SUPERIORITY|||||||0.5333|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 2||||0.5333
72327951|NCT03541499|144180441|SUPERIORITY|||||||0.142|||||||Barnard's exact test|||IgG, any time point||||0.142
72327952|NCT03541499|144180442|SUPERIORITY|||||||0.836|||||||Barnard's exact test|||IgA, any time point||||0.836
72420286|NCT02323646|144352066|SUPERIORITY|||||||0.8791|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 2||||0.8791
72420287|NCT02323646|144352066|SUPERIORITY|||||||0.3666|||||||Wilcoxon Rank-Sum Test|||Percentage Change: Course 2, Week 24 Follow-up||||0.3666
72420288|NCT02323646|144352066|SUPERIORITY|||||||0.345|||||||Wilcoxon Rank-Sum Test|||Percentage Change: Course 2, Week 24 Follow-up||||0.3450
72420289|NCT02323646|144352067|SUPERIORITY|||||||0.0473|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 1||||0.0473
72420290|NCT02323646|144352067|SUPERIORITY|||||||0.0191|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 1||||0.0191
72420291|NCT02323646|144352067|SUPERIORITY|||||||0.0749|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 2||||0.0749
72420292|NCT02323646|144352067|SUPERIORITY|||||||0.0233|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 2||||0.0233
72420293|NCT02323646|144352067|SUPERIORITY|||||||0.7569|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 2, Week 24 Follow-up Visit||||0.7569
72420294|NCT02323646|144352067|SUPERIORITY|||||||0.5399|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 2, Week 24 Follow-up Visit||||0.5399
72420295|NCT02323646|144352068|SUPERIORITY|||||||0.1683|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 1||||0.1683
72420296|NCT02323646|144352068|SUPERIORITY|||||||0.256|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 1||||0.2560
72420297|NCT02323646|144352068|SUPERIORITY|||||||0.4997|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 2||||0.4997
72420298|NCT02323646|144352068|SUPERIORITY|||||||0.1334|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 2||||0.1334
72420299|NCT02323646|144352068|SUPERIORITY|||||||0.0323|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 2, Week 24 Follow-up Visit||||0.0323
72420300|NCT02323646|144352068|SUPERIORITY|||||||0.3847|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 2, Week 24 Follow-up Visit||||0.3847
72420301|NCT02323646|144352069|SUPERIORITY|||||||0.6356|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 1||||0.6356
72420302|NCT02323646|144352069|SUPERIORITY|||||||0.9539|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 1||||0.9539
72420303|NCT02323646|144352069|SUPERIORITY|||||||0.5219|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 2||||0.5219
72420304|NCT02323646|144352069|SUPERIORITY|||||||0.2678|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 2||||0.2678
72420305|NCT02323646|144352069|SUPERIORITY|||||||0.3086|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 2, Week 24 Follow-up Visit||||0.3086
72420306|NCT02323646|144352069|SUPERIORITY|||||||0.3847|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 2, Week 24 Follow-up Visit||||0.3847
72420307|NCT02323646|144352070|SUPERIORITY|||||||0.8393|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 1||||0.8393
72420308|NCT02323646|144352070|SUPERIORITY|||||||0.1361|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 1||||0.1361
72327953|NCT03541499|144180442|SUPERIORITY|||||||1|||||||Barnard's exact test|||IgA, any time point||||1.000
72327954|NCT03541499|144180442|SUPERIORITY|||||||0.526|||||||Barnard's exact test|||IgG, any time point||||0.526
72327955|NCT03541499|144180442|SUPERIORITY|||||||0.119|||||||Barnard's exact test|||IgG, any time point||||0.119
72327956|NCT03541499|144180443|SUPERIORITY|||||||0.271|||||||Barnard's exact test|||Any time point||||0.271
72327957|NCT03541499|144180443|SUPERIORITY|||||||0.226|||||||Barnard's exact test|||Any time point||||0.226
72327958|NCT03541499|144180444|SUPERIORITY|||||||0.783|||||||Barnard's exact test|||Any time point||||0.783
72327959|NCT03541499|144180444|SUPERIORITY|||||||0.001|||||||Barnard's exact test|||Any time point||||0.001
72327960|NCT03541499|144180445|SUPERIORITY|||||||0.745|||||||Barnard's exact test|||Any time point||||0.745
72327961|NCT03541499|144180445|SUPERIORITY|||||||0.068|||||||Barnard's exact test|||Any time point||||0.068
72327962|NCT03541499|144180446|SUPERIORITY|||||||0.585|||||||Barnard's exact test|||Any time point||||0.585
72327963|NCT03541499|144180446|SUPERIORITY|||||||1|||||||Barnard's exact test|||Any time point||||1.000
72327964|NCT02131662|144180448|SUPERIORITY_OR_OTHER||Percentage difference|58.28|||||TWO_SIDED|95.0|44.55|70.94||||||The placebo-adjusted amenorrhea rate was summarized by dose with unconditional 2-sided 95% confidence intervals for each active treatment group. This unconditional confidence interval was calculated by inverting 2 separate one-sided tests of half the nominal significance level each.||70.94|44.55|
72420309|NCT02323646|144352070|SUPERIORITY|||||||0.0382|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 2||||0.0382
72327965|NCT02131662|144180448|SUPERIORITY_OR_OTHER||Percentage difference|52.37|||||TWO_SIDED|95.0|38.8|65.42||||||The placebo-adjusted amenorrhea rate was summarized by dose with unconditional 2-sided 95% confidence intervals for each active treatment group. This unconditional confidence interval was calculated by inverting 2 separate one-sided tests of half the nominal significance level each.||65.42|38.8|
72327966|NCT02131662|144180448|SUPERIORITY_OR_OTHER||Percentage difference|54.01|||||TWO_SIDED|95.0|40.41|66.95||||||The placebo-adjusted amenorrhea rate was summarized by dose with unconditional 2-sided 95% confidence intervals for each active treatment group. This unconditional confidence interval was calculated by inverting 2 separate one-sided tests of half the nominal significance level each.||66.95|40.41|
72327967|NCT02131662|144180448|SUPERIORITY_OR_OTHER||Percentage difference|28.28|||||TWO_SIDED|95.0|15.92|41.5||||||The placebo-adjusted amenorrhea rate was summarized by dose with unconditional 2-sided 95% confidence intervals for each active treatment group. This unconditional confidence interval was calculated by inverting 2 separate one-sided tests of half the nominal significance level each.||41.5|15.92|
72327968|NCT01402869|144180461|NON_INFERIORITY_OR_EQUIVALENCE|Power of 80|||||<|0.001||||||LSD post hoc test was used for multiple group comparisons. P\<.05|ANOVA|LSD post hoc test was used for multiple group comparisons.||Null hypothesis: There is no statistically significant difference in peak methemoglobin blood levels following the administration of prilocaine, lidocaine, or no local anesthetic in pre-cooperative children undergoing comprehensive dental rehabilitation under general anesthesia.||||<.001
72327969|NCT01402869|144180461|NON_INFERIORITY_OR_EQUIVALENCE|Power of 80|||||<|0.001||||||P\<.05|Least significant difference post hoc|||LSD post hoc pairwise comparison||||<.001
72327970|NCT01402869|144180461|NON_INFERIORITY_OR_EQUIVALENCE|Power of 80|||||<|0.001||||||P\<.05|least significant difference post hoc|||LSD post hoc pairwise comparison||||<.001
72420310|NCT02323646|144352070|SUPERIORITY|||||||0.6273|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 2||||0.6273
72420311|NCT02323646|144352070|SUPERIORITY|||||||0.8237|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 2, Week 24 Follow-up Visit||||0.8237
72327971|NCT01402869|144180461|NON_INFERIORITY_OR_EQUIVALENCE|Power of 80|||||=|0.89||||||P\<.05|Least significant difference post hoc|||LSD post hoc pairwise comparison||||=.89
72327972|NCT01402869|144180462|NON_INFERIORITY_OR_EQUIVALENCE|Power of 80|||||<|0.001|||||||ANOVA|LSD post hoc test was used for multiple group comparisons.||Null hypothesis: There is no statistically significant difference in the time frame to peak methemoglobin levels following the administration of prilocaine, lidocaine, or no local anesthetic in pre-cooperative children undergoing comprehensive dental rehabilitation under general anesthesia.||||<.001
72327973|NCT01402869|144180462|NON_INFERIORITY_OR_EQUIVALENCE|Power of 80|||||=|0.43||||||P\<.05|Least significant difference post hoc|||LSD post hoc pairwise comparison||||=.43
72327974|NCT01402869|144180462|NON_INFERIORITY_OR_EQUIVALENCE|Power of 80|||||<|0.001||||||P\<.05|Least significant difference post hoc|||LSD post hoc pairwise comparison||||<.001
72327975|NCT01402869|144180462|NON_INFERIORITY_OR_EQUIVALENCE|Power of 80|||||<|0.001||||||P\<.05|Least significant difference post hoc|||LSD post hoc pairwise comparison||||<.001
72327976|NCT01402869|144180463|NON_INFERIORITY_OR_EQUIVALENCE|Power of 80|||||<|0.001||95.0||||P\<.05|ANOVA|LSD post hoc test was used for multiple group comparisons.||Null hypothesis: There is no statistically significant difference in delta methemoglobin blood levels following the administration prilocaine, lidocaine, or no local anesthetic in pre-cooperative children undergoing comprehensive dental rehabilitation under general anesthesia.||||<.001
72327977|NCT01402869|144180463|NON_INFERIORITY_OR_EQUIVALENCE|Power of 80|||||<|0.001||||||P\<.05|Least significant difference post hoc|||LSD post hoc pairwise comparison||||<.001
72327978|NCT01402869|144180463|NON_INFERIORITY_OR_EQUIVALENCE|Power of 80|||||<|0.001||||||P\<.05|Least significant difference post hoc|||LSD post hoc pairwise comparison||||<.001
72420312|NCT02323646|144352070|SUPERIORITY|||||||0.137|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 2, Week 24 Follow-up Visit||||0.1370
72420313|NCT02323646|144352071|SUPERIORITY|||||||0.7949|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 1||||0.7949
72420314|NCT02323646|144352071|SUPERIORITY|||||||0.1928|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 1||||0.1928
72420315|NCT02323646|144352071|SUPERIORITY|||||||1|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 2||||1.0000
72420316|NCT02323646|144352071|SUPERIORITY|||||||0.392|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 2||||0.3920
72327979|NCT01402869|144180463|NON_INFERIORITY_OR_EQUIVALENCE|Power of 80|||||=|0.92||||||P\<.05|Least significant difference post hoc|||LSD post hoc pairwise comparison||||=.92
72327980|NCT01740687|144180464|OTHER||95% upper Bayesian credible interval|1.23|||||||||||||%|predetermined study success threshold of 2.1% at 1 year||||
72327981|NCT01740687|144180465|OTHER||95% upper Bayesian credible interval|1.33|||||||||||||%|predetermined study success threshold of 2.8% at 3 years||||
72327982|NCT01963767|144180472|SUPERIORITY_OR_OTHER|||||||0.03|||||||ANCOVA|||Ancovas were conducted with group as the between subjects factor and performance at baseline as the covariate.||||.03
72327983|NCT03941483|144180479|SUPERIORITY||Risk Ratio (RR)|1.174||||0.595|TWO_SIDED|90.0|0.715|1.927|||Chi-squared|||||1.927|0.715|0.595
72327984|NCT03941483|144180480|SUPERIORITY||Risk Ratio (RR)|1.297||||0.335|TWO_SIDED|90.0|0.831|2.026|||Chi-squared|||||2.026|0.831|0.335
72327985|NCT03941483|144180481|SUPERIORITY||Risk Ratio (RR)|1.025||||0.773|TWO_SIDED|90.0|0.891|1.179|||Chi-squared|||||1.179|0.891|0.773
72327986|NCT03941483|144180482|SUPERIORITY||Risk Ratio (RR)|1.038||||0.563|TWO_SIDED|90.0|0.935|1.152|||Chi-squared|||||1.152|0.935|0.563
72327987|NCT03941483|144180483|SUPERIORITY||Risk Ratio (RR)|1.174||||0.717|TWO_SIDED|90.0|0.567|2.429|||Chi-squared|||||2.429|0.567|0.717
72327988|NCT03941483|144180484|SUPERIORITY||Risk Ratio (RR)|1.614||||0.266|TWO_SIDED|90.0|0.789|3.3|||Chi-squared|||||3.300|0.789|0.266
72327989|NCT01082081|144180485|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|4.77||||0.0004|TWO_SIDED|95.0|2.15|7.39|||ANCOVA|ANCOVA model included factors for treatment as a fixed effect and baseline assessment of pain intensity (VAS score) as a covariate.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered no difference in SPRID\^6h between Paracetamol 1000 mg caplet and Paracetamol 500 mg caplet.||7.39|2.15|0.0004
72327990|NCT01082081|144180485|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|7.25|||<|0.0001|TWO_SIDED|95.0|4.04|10.45|||ANCOVA|ANCOVA model included factors for treatment as a fixed effect and baseline assessment of pain intensity (VAS score) as a covariate.|Difference was first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered no difference in SPRID\^6h between Paracetamol 1000 mg caplet and placebo caplet.||10.45|4.04|<0.0001
72327991|NCT01082081|144180485|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|2.48||||0.1307|TWO_SIDED|95.0|-0.74|5.69|||ANCOVA|ANCOVA model included factors for treatment as a fixed effect and baseline assessment of pain intensity (VAS score) as a covariate.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered no difference in SPRID\^6h between Paracetamol 500 mg caplet and placebo caplet.||5.69|-0.74|0.1307
72327992|NCT00932035|144180500|SUPERIORITY|To achieve a power of 0.84, a sample size of 72 patients, evenly distributed is required. With 36 patients per group, a Fisher's exact test with a one-sided alpha of 0.05 will have a 84% power to detect the difference between the experimental group (axillary reverse mapping) of 5% or less and a control group (standard dissection) of 30% or more. Response estimates were chosen based on reported lymphedema rates.||||||0.45|||||||Fisher Exact|||||||0.45
72327993|NCT00932035|144180501|SUPERIORITY|||||||0.5|||||||Fisher Exact|||||||0.50
72327994|NCT00932035|144180502|SUPERIORITY|||||||0.59|||||||Chi-squared|||||||0.59
72327995|NCT01530178|144180540|OTHER|Non-specified|Mean Difference (Final Values)|-27.91||||0.003|TWO_SIDED|95.0|-44.7|-11.2|||ANOVA|||||-11.2|-44.7|0.003
72420317|NCT02323646|144352071|SUPERIORITY|||||||0.541|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 2, Week 24 Follow-up Visit||||0.5410
72327996|NCT01530178|144180540|OTHER|Non-specified|Mean Difference (Final Values)|-2.131||||0.68|TWO_SIDED|95.0|-12.91|8.652|||ANOVA|||||8.652|-12.91|0.68
72327997|NCT01530178|144180540|OTHER||Mean Difference (Final Values)|-25.78||||0.0005|TWO_SIDED|95.0|-38.39|-13.17|||ANOVA|||||-13.17|-38.39|0.0005
72327998|NCT02709512|144180541|SUPERIORITY|Relative Risk Ratio (ADIPemPlatinum/PlaceboPemPlatinum) is the common relative risk of having a response (CR or PR) based on the Mantel-Haenszel estimator controlling for tumor histology. A relative risk ratio greater than one is favorable to ADIPemPlatinum.|Risk Ratio (RR)|1.02||||0.9489|TWO_SIDED|95.0|0.5|2.11|||Cochran-Mantel-Haenszel|||||2.11|0.50|0.9489
72327999|NCT02709512|144180542|SUPERIORITY||Cox Proportional Hazard|0.64||||0.0078|TWO_SIDED|95.0|0.47|0.88|||Log Rank|||||0.88|0.47|0.0078
72328000|NCT02709512|144180543|SUPERIORITY||Cox Proportional Hazard|0.71||||0.0234|TWO_SIDED|95.0|0.55|0.93|||Log Rank|||||0.93|0.55|0.0234
72328001|NCT02709512|144180544|SUPERIORITY||Cox Proportional Hazard|0.65||||0.0193|TWO_SIDED|95.0|0.46|0.9|||Log Rank|||||0.90|0.46|0.0193
72328002|NCT00600106|144180551|SUPERIORITY_OR_OTHER|All tests were two-sided with p values \<0.05.||||||0.36|||||||t-test (nonparametric Wilcoxon test)|||"Data were presented in tables as means and SDs for continuous variables and frequencies for categorical variables. Comparisons between the placebo and 1/10 NA/EE groups were don using Wilcoxon rank sum test for continuous measurement and Fisher's exact test for discrete data. The strategy of analysis was intention to treat with comparing the study groups in term of treatment to which they were randomly allocated."||||0.36
72328003|NCT00600106|144180552|SUPERIORITY_OR_OTHER|||||||0.93|TWO_SIDED||||||Wilcoxon rank sum test|||||||0.93
72328004|NCT00600106|144180553|SUPERIORITY_OR_OTHER|All tests were two-sided with p values \<0.05.||||||0.77|||||||Wilcoxon rank sum test|||"Data were presented in tables as means and SDs for continuous variables and frequencies for categorical variables. Comparisons between the placebo and 1/10 NA/EE groups were don using Wilcoxon rank sum test for continuous measurement and Fisher's exact test for discrete data. The strategy of analysis was intention to treat with comparing the study groups in term of treatment to which they were randomly allocated."||||0.77
72328005|NCT00600106|144180555|SUPERIORITY_OR_OTHER|All tests were two-sided with p values \<0.05.||||||0.38|||||||Wilcoxon rank sum test|||"Data were presented in tables as means and SDs for continuous variables and frequencies for categorical variables. Comparisons between the placebo and 1/10 NA/EE groups were don using Wilcoxon rank sum test for continuous measurement and Fisher's exact test for discrete data. The strategy of analysis was intention to treat with comparing the study groups in term of treatment to which they were randomly allocated."||||0.38
72420318|NCT02323646|144352071|SUPERIORITY|||||||0.4602|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 2, Week 24 Follow-up Visit||||0.4602
72420319|NCT02323646|144352072|SUPERIORITY|||||||0.9536|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 1||||0.9536
72328006|NCT00600106|144180559|SUPERIORITY_OR_OTHER|||||||0.17|TWO_SIDED||||||t-test (nonparametric Wilcoxon test)|||"Data were presented in tables as means and SDs for continuous variables and frequencies for categorical variables. Comparisons between the placebo and 1/10 NA/EE groups were don using Wilcoxon rank sum test for continuous measurement and Fisher's exact test for discrete data. The strategy of analysis was intention to treat with comparing the study groups in term of treatment to which they were randomly allocated. All tests were two-sided with p values \<0.05."||||0.17
72328007|NCT00600106|144180560|SUPERIORITY_OR_OTHER|||||||0.49|TWO_SIDED||||||Wilcoxon rank sum test|||||||0.49
72328008|NCT00600106|144180561|SUPERIORITY_OR_OTHER|||||||0.77|TWO_SIDED||||||Wilcoxon rank sum test|||||||0.77
72328009|NCT00600106|144180562|SUPERIORITY_OR_OTHER|||||||0.4|TWO_SIDED||||||Wilcoxon rank sum test|||||||0.40
72328010|NCT00600106|144180563|SUPERIORITY_OR_OTHER|||||||0.99|TWO_SIDED||||||Wilcoxon rank sum test|||||||0.99
72328011|NCT00600106|144180564|SUPERIORITY_OR_OTHER|||||||0.21|TWO_SIDED||||||Wilcoxon rank sum test|||||||0.21
72328012|NCT00252512|144180565|SUPERIORITY||||||<|0.001||||||Above is calculated p value, a priori threshold for significance set at \<.05|GEE full factorial modeling|||||||<.001
72328013|NCT00252512|144180566|SUPERIORITY|||||||0.015||||||a priori threshold of \<.05|t-test, 2 sided|||8 week analysis||||.015
72328014|NCT00252512|144180566|SUPERIORITY|||||||0.45||||||a priori threshold of \<.05|t-test, 2 sided|||6 month analysis||||0.45
72328015|NCT00252512|144180566|SUPERIORITY|||||||0.0497||||||a prior threshold of .05|t-test, 2 sided|||12 month analysis||||.0497
72328016|NCT00252512|144180567|SUPERIORITY||||||>|0.05||||||a priori threshold \<.05|Estimation Equation mean modeling|||Costs for period between 6 month follow-up and 12 month follow up.||||>.05
72328017|NCT00252512|144180567|SUPERIORITY||||||>|0.05|||||||Estimating Equation mean modeling|||Costs for period between 6 month follow up and 12 month follow up.||||>.05
72328018|NCT00252512|144180568|SUPERIORITY|||||||0.28||||||a priori threshold \<.05|Chi-squared|||Analysis for 8 week follow up||||.28
72328019|NCT00252512|144180568|SUPERIORITY|||||||0.013||||||A priori threshold \<.05|Chi-squared|||Analysis for 6 month follow up||||.013
72328020|NCT00252512|144180568|SUPERIORITY|||||||0.76||||||A priori threshold \<.05|Chi-squared|||Analysis for 12 month follow up||||.76
72328021|NCT00252512|144180569|SUPERIORITY|||||||0.66||||||A priori threshold \<.05|Chi-squared|||Analysis for 8 week follow-up||||.66
72328022|NCT00252512|144180569|SUPERIORITY|||||||0.37||||||A priori threshold \<.05|Chi-squared|||Analysis for 6 month follow up.||||.37
72328023|NCT00252512|144180569|SUPERIORITY|||||||0.19||||||a priori threshold \<.05|Chi-squared|||Analysis for 12 month follow up.||||.19
72328024|NCT00252512|144180570|SUPERIORITY|||||||0.05||||||A priori threshold of \<.05|Chi-squared|||Analysis for 8 week follow-up||||.05
72328025|NCT00252512|144180570|SUPERIORITY|||||||0.8||||||A priori threshold of \<.05|Chi-squared|||Analysis for 6 month follow-up.||||.80
72328026|NCT00252512|144180570|SUPERIORITY|||||||0.12||||||A priori threshold of \<.05|Chi-squared|||Analysis for 12 month follow-up.||||.12
72328027|NCT01734785|144180593|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001||95.0|-0.93|-0.46|||Mixed Models Analysis|The unstructured covariance structure has been used to fit the mixed model.|Mean Difference (Final Values) is actually the Adjusted mean difference calculated as Empagliflozin 25 mg minus Placebo.|Superiority of Empagliflozin 25 mg vs. placebo: change in HbA1c using a restricted maximum likelihood (REML)- based mixed model repeated measures (MMRM) approach. Model includes baseline HbA1c as linear covariate(s) \& baseline Estimated glomerula filtration rate (eGFR), geographical region, treatment, visit, visit by treatment interaction as fixed effect(s).||-0.46|-0.93|<0.0001
72328028|NCT01734785|144180593|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.79|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001||95.0|-1.02|-0.55|||Mixed Models Analysis|The unstructured covariance structure has been used to fit the mixed model.|Mean Difference (Final Values) is actually the Adjusted mean difference calculated as Empagliflozin 10 mg minus Placebo.|Superiority of Empagliflozin 10 mg vs. placebo: change in HbA1c using a restricted maximum likelihood (REML)- based mixed model repeated measures (MMRM) approach. Model includes baseline HbA1c as linear covariate(s) \& baseline Estimated glomerula filtration rate (eGFR), geographical region, treatment, visit, visit by treatment interaction as fixed effect(s).||-0.55|-1.02|<0.0001
72328029|NCT01734785|144180594|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.09|STANDARD_ERROR_OF_MEAN|0.26|<|0.0001||95.0|-2.61|-1.57|||Mixed Models Analysis|The unstructured covariance structure has been used to fit the mixed model.|Mean Difference (Final Values) is actually the Adjusted mean difference calculated as Empagliflozin 25 mg minus Placebo.|Superiority of Empagliflozin 25 mg vs. placebo: change in FPG using a restricted maximum likelihood (REML)- based mixed model repeated measures (MMRM) approach. Model includes baseline FPG, baseline HbA1c as linear covariate(s) \& baseline eGFR, geographical region, treatment, visit, visit by treatment interaction as fixed effect(s).||-1.57|-2.61|<0.0001
72328030|NCT01734785|144180594|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.8|STANDARD_ERROR_OF_MEAN|0.26|<|0.0001||95.0|-2.31|-1.28|||Mixed Models Analysis|The unstructured covariance structure has been used to fit the mixed model.|Mean Difference (Final Values) is actually the Adjusted mean difference calculated as Empagliflozin 10 mg minus Placebo.|Superiority of Empagliflozin 10 mg vs. placebo: change in FPG using a restricted maximum likelihood (REML)- based mixed model repeated measures (MMRM) approach. Model includes baseline FPG, baseline HbA1c as linear covariate(s) \& baseline eGFR, geographical region, treatment, visit, visit by treatment interaction as fixed effect(s).||-1.28|-2.31|<0.0001
72328031|NCT01734785|144180595|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.22|STANDARD_ERROR_OF_MEAN|0.36|<|0.0001||95.0|-2.92|-1.52|||Mixed Models Analysis|The unstructured covariance structure has been used to fit the mixed model.|Mean Difference (Final Values) is actually the Adjusted mean difference calculated as Empagliflozin 25 mg minus Placebo.|Superiority of Empagliflozin 25 mg vs. placebo: change in body weight using a restricted maximum likelihood (REML)- based mixed model repeated measures (MMRM) approach. Model includes baseline weight, baseline HbA1c as linear covariate(s) \& baseline eGFR, geographical region, treatment, visit, visit by treatment interaction as fixed effect(s).||-1.52|-2.92|<0.0001
72420320|NCT02323646|144352072|SUPERIORITY|||||||0.1355|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 1||||0.1355
72420321|NCT02323646|144352072|SUPERIORITY|||||||0.9396|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 2||||0.9396
72328032|NCT01734785|144180595|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.77|STANDARD_ERROR_OF_MEAN|0.36|<|0.0001||95.0|-3.47|-2.07|||Mixed Models Analysis|The unstructured covariance structure has been used to fit the mixed model.|Mean Difference (Final Values) is actually the Adjusted mean difference calculated as Empagliflozin 10 mg minus Placebo.|Superiority of Empagliflozin 10 mg vs. placebo:change in body weight using a restricted maximum likelihood (REML)- based mixed model repeated measures (MMRM) approach. Model includes baseline weight, baseline HbA1c as linear covariate(s) \& baseline eGFR, geographical region, treatment, visit, visit by treatment interaction as fixed effect(s).||-2.07|-3.47|<0.0001
72328033|NCT00293813|144180604|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.1||||||95.0|2.6|5.7|||ANCOVA|||||5.7|2.6|
72328034|NCT00293813|144180604|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.0||||||95.0|-0.6|2.6|||ANCOVA|||||2.6|-.6|
72328035|NCT01139411|144180606|SUPERIORITY_OR_OTHER|||||||0.06||||||Threshold for significance: 0.05|ANCOVA|||"Null hypothesis was that the amount of weight lost by adolescents in Enhanced Parent Involvement and Minimal Parent involvement would not be significantly different. The study was powered at .8 to achieve a medium effect size (f = .26; partial eta sq. = 0.06).~The end-of-treatment BMI value was the dependent variable, with the baseline BMI value entered as a covariate."||||0.06
72328036|NCT01139411|144180607|SUPERIORITY_OR_OTHER|||||||0.58||||||Threshold for significance: 0.05|ANCOVA|||The end-of-treatment value was the dependent variable, with the baseline value entered as a covariate.||||0.58
72328037|NCT01139411|144180608|SUPERIORITY_OR_OTHER|||||||0.19||||||Threshold for significance: 0.05|ANCOVA|||||||0.19
72328038|NCT01139411|144180609|SUPERIORITY_OR_OTHER|||||||0.72||||||Threshold for significance: 0.05|ANCOVA|||||||0.72
72328039|NCT01139411|144180610|SUPERIORITY_OR_OTHER|||||||0.41|||||||ANCOVA|||||||0.41
72328040|NCT01139411|144180611|SUPERIORITY_OR_OTHER|||||||0.01||||||Threshold for significance: 0.05|ANCOVA|||||||0.01
72328041|NCT01139411|144180612|SUPERIORITY_OR_OTHER|||||||0.61||||||Threshold for significance: 0.05|ANCOVA|||||||0.61
72328042|NCT01521923|144180613|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.719|||=|0.112|TWO_SIDED|95.0|0.881|3.354|||Regression, Logistic|||In order to control the overall study-wise Type I error rate at 5 %, hypothesis testing was performed in a hierarchical order beginning with the CZP standard maintenance dosing (200 mg Q2W) + MTX group vs the CZP stopped dosing (PBO) + MTX group. If this analysis was statistically significant at the alpha =0.05 level, then an additional comparison of the CZP reduced frequency dosing (200 mg Q4W) + MTX group vs the CZP stopped dosing + MTX group was performed with testing at the alpha =0.05 level||3.354|0.881|=0.112
72328043|NCT01521923|144180613|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.889|||=|0.041|TWO_SIDED|95.0|1.026|3.48|||Regression, Logistic|||In order to control the overall study-wise Type I error rate at 5 %, hypothesis testing was performed in a hierarchical order. A hierarchical test procedure was applied to protect the Overall significance level for the multiplicity of endpoints. Hypothesis testing was performed in the following predefined order, each at a 2-sided 95 % alpha level||3.480|1.026|=0.041
72328044|NCT00460655|144180658|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.428||||0.006||95.0|-5.841|-1.016|||t-test, 2 sided|||||-1.016|-5.841|0.006
72328045|NCT01816776|144180671|SUPERIORITY||Risk Difference (RD)|41.0|||<|0.0001|TWO_SIDED|95.0|25.0|54.0||1-sided. p\<0.025 considered significant.|Fisher Exact||Risk difference = Treatment - Control|||54|25|<0.0001
72328046|NCT01816776|144180673|SUPERIORITY||Mean Difference (Net)|-22.8|||<|0.0001|TWO_SIDED|95.0|-29.0|-16.6||1-sided. Secondary endpoints hierarchically tested with p\<0.025 considered significant.|Wilcoxon (Mann-Whitney)||Mean difference = Treatment - Control|||-16.6|-29.0|<0.0001
72328047|NCT01816776|144180674|SUPERIORITY||Mean Difference (Net)|-25.0|||<|0.0001|TWO_SIDED|95.0|-31.2|-18.7||Secondary endpoints hierarchically tested with p\<0.025 considered significant.|t-test, 1 sided||Mean difference = Treatment - Control|||-18.7|-31.2|<0.0001
72328048|NCT01816776|144180675|SUPERIORITY||Mean Difference (Net)|-15.2|||<|0.0001|TWO_SIDED|95.0|-21.6|-8.7||Secondary endpoints hierarchically tested with p\<0.025 considered significant.|t-test, 1 sided||Mean difference = Treatment - Control|||-8.7|-21.6|<0.0001
72328049|NCT01816776|144180676|SUPERIORITY||Mean Difference (Net)|2.4||||0.0244|TWO_SIDED|95.0|-0.4|5.1||1-sided. Secondary endpoints hierarchically tested with p\<0.025 considered significant.|Wilcoxon (Mann-Whitney)||Mean difference = Treatment - Control|||5.1|-0.4|0.0244
72328050|NCT01816776|144180677|SUPERIORITY||Risk Difference (RD)|55.0|||<|0.0001|TWO_SIDED|95.0|40.0|68.0||1-sided. Secondary endpoints hierarchically tested with p\<0.025 considered significant.|Fisher Exact||Risk difference = Treatment - Control|||68|40|<0.0001
72328051|NCT01816776|144180678|SUPERIORITY||Mean Difference (Net)|-22.7|||<|0.0001|TWO_SIDED|95.0|-28.9|-16.5||Secondary endpoints hierarchically tested with p\<0.025 considered significant.|t-test, 1 sided||Mean difference = Treatment - Control|||-16.5|-28.9|<0.0001
72328052|NCT01816776|144180679|SUPERIORITY||Mean Difference (Net)|-3.7|||<|0.0001|TWO_SIDED|95.0|-5.5|-2.0||1-sided. Secondary endpoints hierarchically tested with p\<0.025 considered significant.|Wilcoxon (Mann-Whitney)||Mean difference = Treatment - Control|||-2.0|-5.5|<0.0001
72328053|NCT00635349|144180698|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was to be concluded if the lower confidence limit interval was less than -1.0 (1-sided , 97.5% confidence interval)|Mean Difference (Final Values)|1.81||||0.4258|ONE_SIDED|97.5|-6.31||||t-test, 1 sided||||||-6.31|0.4258
72328054|NCT00635349|144180699|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.68||||0.0628|ONE_SIDED|97.5|-1.41||||t-test, 1 sided||||||-1.41|0.0628
72328055|NCT00635349|144180700|SUPERIORITY_OR_OTHER|||||||0.0131||||||Day 29: p-value was calculated by fisher exact test|Fisher Exact|||||||0.0131
72328056|NCT00635349|144180700|SUPERIORITY_OR_OTHER|||||||0.9834||||||Day 57; p-value was calculated by Chi-squared test|Chi-squared|||||||0.9834
72328057|NCT00635349|144180700|SUPERIORITY_OR_OTHER|||||||0.1131||||||Day 85; p-value was calculated by Chi-squared test|Chi-squared|||||||0.1131
72328058|NCT01313910|144180727|SUPERIORITY_OR_OTHER|||||||0.008||95.0|||||Wilcoxon (Mann-Whitney)|||Wilcoxin-rank test used to determine decrease in bowel movements/day after 8 weeks of intervention||||0.008
72328059|NCT01313910|144180728|SUPERIORITY_OR_OTHER|||||||0.11|||||||Wilcoxon (Mann-Whitney)|||||||0.11
72328060|NCT01313910|144180729|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||||||>0.05
72328061|NCT01313910|144180731|SUPERIORITY_OR_OTHER|||||||0.016|||||||Wilcoxon (Mann-Whitney)|||||||0.016
72328062|NCT01340664|144180737|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-0.44|STANDARD_ERROR_OF_MEAN|0.098|<|0.001|TWO_SIDED|95.0|-0.637|-0.251|||ANCOVA|||||-0.251|-0.637|<0.001
72420322|NCT02323646|144352072|SUPERIORITY|||||||0.9102|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 2||||0.9102
72420323|NCT02323646|144352072|SUPERIORITY|||||||0.6266|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 2, Week 24 Follow-up Visit||||0.6266
72420324|NCT02323646|144352072|SUPERIORITY|||||||0.9302|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 2, Week 24 Follow-up Visit||||0.9302
72420325|NCT02323646|144352073|SUPERIORITY|||||||0.817|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 1||||0.8170
72420326|NCT02323646|144352073|SUPERIORITY|||||||0.8177|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 1||||0.8177
72328063|NCT01340664|144180737|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.098|<|0.001|TWO_SIDED|95.0|-0.792|-0.407|||ANCOVA|||||-0.407|-0.792|<0.001
72328064|NCT01340664|144180738|SUPERIORITY_OR_OTHER||Least-Sqaures Mean Difference|-23.6|STANDARD_ERROR_OF_MEAN|4.673|<|0.001|TWO_SIDED|95.0|-32.78|-14.38|||ANCOVA|||||-14.38|-32.78|<0.001
72328065|NCT01340664|144180738|SUPERIORITY_OR_OTHER||Least-Sqaures Mean Difference|-24.0|STANDARD_ERROR_OF_MEAN|4.661|<|0.001||95.0|-33.18|-14.83|||ANCOVA|||||-14.83|-33.18|<0.001
72328066|NCT01340664|144180739|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-2.2|STANDARD_ERROR_OF_MEAN|0.5|<|0.001|TWO_SIDED|95.0|-3.1|-1.3|||ANCOVA|||||-1.3|-3.1|<0.001
72328067|NCT01340664|144180739|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-2.6|STANDARD_ERROR_OF_MEAN|0.5|<|0.001|TWO_SIDED|95.0|-3.5|-1.7|||ANCOVA|||||-1.7|-3.5|<0.001
72420327|NCT02323646|144352073|SUPERIORITY|||||||0.3167|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 2||||0.3167
72328068|NCT01340664|144180740|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.43||||0.013|TWO_SIDED|95.0|1.21|4.9|||Regression, Logistic|||||4.90|1.21|0.013
72328069|NCT01340664|144180740|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.38|||<|0.001|TWO_SIDED|95.0|1.68|6.81|||Regression, Logistic|||||6.81|1.68|<0.001
72420328|NCT02323646|144352073|SUPERIORITY|||||||0.5503|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 2||||0.5503
72420329|NCT02323646|144352073|SUPERIORITY|||||||0.6929|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 2, Week 24 Follow-up Visit||||0.6929
72420330|NCT02323646|144352073|SUPERIORITY|||||||0.726|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 2, Week 24 Follow-up Visit||||0.7260
72328070|NCT01637584|144180780|SUPERIORITY_OR_OTHER||||||<|0.001||||||Threshold for significance: \<.05|Full Factorial ANOVAs and Paired T-tests|||Wakefulness \> Non-Rapid Eye Movement (NREM): Mean K-cluster voxels (Ke)=15,586: x,y,z= -36, -74, 0. Left Brodmann's Area (BA) 3, 6, 7, 10, 17, 19, 20,21,23, 38||||<0.001
72328071|NCT01637584|144180780|SUPERIORITY_OR_OTHER|||||||0.039||||||Threshold for significance: \<.05|Full Factorial ANOVAs and Paired T-tests|||Wakefulness \< NREM: Ke=7,013: x,y,z= 26, 22, -40. Right BA 4, 10-14, 21, 25, 32, 38, 45;||||0.039
72328072|NCT01637584|144180780|SUPERIORITY_OR_OTHER|||||||0.701||||||Threshold for significance: \<.05|Full Factorial ANOVAs and Paired T-tests|||Wakefulness \> (Rapid Eye Movement (REM): No cluster size, coordinates, or brain regions to report||||0.701
72328073|NCT01637584|144180780|SUPERIORITY_OR_OTHER|||||||1||||||Threshold for significance: \<.05|Full Factorial ANOVAs and Paired T-tests|||Wakefulness \< REM: No cluster size, coordinates, or brain regions to report||||1.00
72328074|NCT01637584|144180780|SUPERIORITY_OR_OTHER|||||||0.03||||||Threshold for significance: \<.05|Full Factorial ANOVAs and Paired T-tests|||Within-state decrease in rCMRglc: Ke=6,150: x,y,z= -30, -30, 2. Left BA 40, insula, hippocampus, caudate, and putamen;||||0.03
72328075|NCT01637584|144180780|SUPERIORITY_OR_OTHER|||||||0.01||||||Threshold for significance: \<.05|Full Factorial ANOVAs and Paired T-tests|||Within-state increase in rCMRglc: Ke=7,049: x,y,z= 66, -18, 26. Right BA 1, 3, 15, 21, 22, 23, 41, 42||||0.01
72328076|NCT02969915|144180798|SUPERIORITY||Risk Ratio (RR)|1.21|||||TWO_SIDED|95.0|0.64|2.26||||||||2.26|0.64|
72328077|NCT02969915|144180799|SUPERIORITY||Risk Ratio (RR)|1.31|||||TWO_SIDED|95.0|0.91|1.9||||||||1.90|0.91|
72328078|NCT02969915|144180800|SUPERIORITY||Risk Ratio (RR)|1.16|||||TWO_SIDED|95.0|0.7|1.95||||||||1.95|0.70|
72328079|NCT02969915|144180801|SUPERIORITY||Risk Ratio (RR)|1.29|||||TWO_SIDED|95.0|0.85|1.95||||||||1.95|0.85|
72328080|NCT02969915|144180802|SUPERIORITY||Risk Ratio (RR)|1.17|||||TWO_SIDED|95.0|0.79|1.75||||||||1.75|0.79|
72328081|NCT02969915|144180803|SUPERIORITY||Risk Ratio (RR)|1.48|||||TWO_SIDED|95.0|0.38|5.76||||||||5.76|0.38|
72328082|NCT02969915|144180804|SUPERIORITY||Risk Ratio (RR)|0.96|||||TWO_SIDED|95.0|0.68|1.36||||||||1.36|0.68|
72328083|NCT02969915|144180805|SUPERIORITY||Risk Ratio, log|1.38|||||TWO_SIDED|95.0|0.77|2.46||||||||2.46|0.77|
72420331|NCT02323646|144352074|SUPERIORITY|||||||0.3896|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 1||||0.3896
72420332|NCT02323646|144352074|SUPERIORITY|||||||0.1358|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 1||||0.1358
72420333|NCT02323646|144352074|SUPERIORITY|||||||0.7903|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 2||||0.7903
72420334|NCT02323646|144352074|SUPERIORITY|||||||0.8206|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 2||||0.8206
72420335|NCT02323646|144352074|SUPERIORITY|||||||0.7891|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 2, Week 24 Follow-up Visit||||0.7891
72420336|NCT02323646|144352074|SUPERIORITY|||||||0.401|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 2, Week 24 Follow-up Visit||||0.4010
72420337|NCT02323646|144352075|SUPERIORITY|||||||0.0294|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 1||||0.0294
72420338|NCT02323646|144352075|SUPERIORITY|||||||0.1934|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 1||||0.1934
72420339|NCT02323646|144352075|SUPERIORITY|||||||0.0442|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 2||||0.0442
72420340|NCT02323646|144352075|SUPERIORITY|||||||0.8314|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 2||||0.8314
72420341|NCT00335452|144352092|SUPERIORITY_OR_OTHER||Relative Risk Reduction (%)|6.1||||0.3037|TWO_SIDED|95.0|-5.8|16.6||The a priori threshold for statistical significance is ≤0.05.|Log Rank|Two-sided stratified by ASA dose level (low or high) and qualifying condition (UA/NSTEMI or STEMI) log-rank test.|The relative risk reduction (high dose treatment regimen (600/150/75 mg) versus standard treatment regimen (300/75/75 mg)) is estimated using stratified Cox proportional hazards model controlling for ASA dose level and qualifying condition.|||16.6|-5.8|0.3037
72328084|NCT02969915|144180806|SUPERIORITY||Risk Ratio (RR)|0.39|||||TWO_SIDED|95.0|0.09|1.8||||||||1.80|0.09|
72328085|NCT02622295|144180833|SUPERIORITY||||||<|0.001|||||||ANOVA|||||||<0.001
72328086|NCT02622295|144180834|SUPERIORITY||||||<|0.001|||||||ANOVA|||||||<0.001
72328087|NCT02622295|144180835|SUPERIORITY||||||<|0.001|||||||ANOVA|||||||<0.001
72328088|NCT02622295|144180836|SUPERIORITY|||||||0.467|||||||ANOVA|||||||0.467
72328089|NCT02622295|144180837|SUPERIORITY||||||<|0.001|||||||ANOVA|||||||<0.001
72328090|NCT02622295|144180838|SUPERIORITY|||||||0.932|||||||ANOVA|||||||0.932
72328091|NCT02622295|144180839|SUPERIORITY|||||||0.326|||||||ANOVA|||||||0.326
72420342|NCT00335452|144352093|SUPERIORITY_OR_OTHER|||||||0.012|TWO_SIDED|||||The a priori threshold for statistical significance is ≤0.05.|Regression, Logistic|logistic regression model including terms for ASA dose level (low or high) and qualifying condition (UA/NSTEMI or STEMI).||||||0.012
72420343|NCT00335452|144352094|SUPERIORITY_OR_OTHER||Relative Risk Reduction (%)|3.1||||0.6047|TWO_SIDED|95.0|-9.2|14.0||The a priori threshold for statistical significance is ≤0.05.|Log Rank|Two-sided stratified by clopidogrel treatment regimen (300/75/75 mg or 600/150/75 mg) log-rank test.|The relative risk reduction (ASA high dose versus ASA low dose) is estimated using stratified Cox proportional hazards model controlling for Clopidogrel treatment regimen.|||14.0|-9.2|0.6047
72420344|NCT00335452|144352095|SUPERIORITY_OR_OTHER||Relative Risk Reduction (%)|-6.5||||0.4579|TWO_SIDED|95.0|-26.0|9.9||The a priori threshold for statistical significance is ≤0.05.|Log Rank|Two-sided stratified by qualifying condition (UA/NSTEMI or STEMI) log-rank test.|The relative risk reduction (high dose treatment regimen (600/150/75 mg) versus standard treatment regimen (300/75/75 mg)) is estimated using a stratified Cox proportional hazards model controlling for qualifying condition.|||9.9|-26.0|0.4579
72328092|NCT02622295|144180840|SUPERIORITY|||||||0.673|||||||ANOVA|||||||0.673
72328093|NCT02622295|144180841|SUPERIORITY|||||||0.539|||||||ANOVA|||||||0.539
72328094|NCT02622295|144180842|SUPERIORITY|||||||0.155|||||||ANOVA|||||||0.155
72328095|NCT02622295|144180843|SUPERIORITY|||||||0.164|||||||ANOVA|||||||0.164
72328096|NCT02622295|144180844|SUPERIORITY|||||||0.493|||||||ANOVA|||||||0.493
72328097|NCT02622295|144180845|SUPERIORITY|||||||0.458|||||||ANOVA|||||||0.458
72328098|NCT01393899|144180846|SUPERIORITY_OR_OTHER||Difference in Percentage|1.44|||||TWO_SIDED|80.0|-12.11|14.99||||||||14.99|-12.11|
72328099|NCT01393899|144180846|SUPERIORITY_OR_OTHER||Difference in Percentage|17.72|||||TWO_SIDED|80.0|4.07|31.37||||||||31.37|4.07|
72328100|NCT01393899|144180847|SUPERIORITY_OR_OTHER||Difference in Percentage|0.61|||||TWO_SIDED|80.0|-11.57|12.79||||||Week 4||12.79|-11.57|
72328101|NCT01393899|144180847|SUPERIORITY_OR_OTHER||Difference in Percentage|0.78|||||TWO_SIDED|80.0|-12.29|13.84||||||Week 8||13.84|-12.29|
72328102|NCT01393899|144180847|SUPERIORITY_OR_OTHER||Difference in Percentage|5.81|||||TWO_SIDED|80.0|-8.04|19.67||||||Week 12||19.67|-8.04|
72328103|NCT01393899|144180847|SUPERIORITY_OR_OTHER||Difference in Percentage|-0.94|||||TWO_SIDED|80.0|-14.56|12.68||||||Week 20||12.68|-14.56|
72328104|NCT01393899|144180847|SUPERIORITY_OR_OTHER||Difference in Percentage|5.26|||||TWO_SIDED|80.0|-6.52|17.04||||||Week 4||17.04|-6.52|
72328105|NCT01393899|144180847|SUPERIORITY_OR_OTHER||Difference in Percentage|-8.53|||||TWO_SIDED|80.0|-21.94|4.88||||||Week 8||4.88|-21.94|
72328106|NCT01393899|144180847|SUPERIORITY_OR_OTHER||Difference in Percentage|3.49|||||TWO_SIDED|80.0|-10.4|17.37||||||Week 12||17.37|-10.40|
72328107|NCT01393899|144180847|SUPERIORITY_OR_OTHER||Difference in Percentage|10.69|||||TWO_SIDED|80.0|-3.08|24.46||||||Week 20||24.46|-3.08|
72328108|NCT01393899|144180848|SUPERIORITY_OR_OTHER||Difference in Percentage|-1.72|||||TWO_SIDED|80.0|-14.06|10.63||||||Week 4||10.63|-14.06|
72328109|NCT01393899|144180848|SUPERIORITY_OR_OTHER||Difference in Percentage|-3.88|||||TWO_SIDED|80.0|-17.15|9.4||||||Week 8||9.40|-17.15|
72328110|NCT01393899|144180848|SUPERIORITY_OR_OTHER||Difference in Percentage|5.81|||||TWO_SIDED|80.0|-8.04|19.67||||||Week 12||19.67|-8.04|
72328111|NCT01393899|144180848|SUPERIORITY_OR_OTHER||Difference in Percentage|1.44|||||TWO_SIDED|80.0|-12.11|14.99||||||Week 20||14.99|-12.11|
72328112|NCT01393899|144180848|SUPERIORITY_OR_OTHER||Difference in Percentage|1.5|||||TWO_SIDED|80.0|-11.88|14.87||||||Week 26||14.87|-11.88|
72328113|NCT01393899|144180848|SUPERIORITY_OR_OTHER||Difference in Percentage|2.93|||||TWO_SIDED|80.0|-9.06|14.92||||||Week 4||14.92|-9.06|
72328114|NCT01393899|144180848|SUPERIORITY_OR_OTHER||Difference in Percentage|-8.53|||||TWO_SIDED|80.0|-21.94|4.88||||||Week 8||4.88|-21.94|
72328115|NCT01393899|144180848|SUPERIORITY_OR_OTHER||Difference in Percentage|1.16|||||TWO_SIDED|80.0|-12.74|15.06||||||Week 12||15.06|-12.74|
72328116|NCT01393899|144180848|SUPERIORITY_OR_OTHER||Difference in Percentage|13.07|||||TWO_SIDED|80.0|-0.63|26.77||||||Week 20||26.77|-0.63|
72328117|NCT01393899|144180848|SUPERIORITY_OR_OTHER||Difference in Percentage|20.1|||||TWO_SIDED|80.0|6.54|33.66||||||Week 26||33.66|6.54|
72328118|NCT01393899|144180849|SUPERIORITY_OR_OTHER||Difference in Percentage|3.43|||||TWO_SIDED|80.0|-10.41|17.28||||||Week 4||17.28|-10.41|
72328119|NCT01393899|144180849|SUPERIORITY_OR_OTHER||Difference in Percentage|1.22|||||TWO_SIDED|80.0|-12.67|15.11||||||Week 8||15.11|-12.67|
72328120|NCT01393899|144180849|SUPERIORITY_OR_OTHER||Difference in Percentage|13.18|||||TWO_SIDED|80.0|-0.31|26.67||||||Week 12||26.67|-0.31|
72328121|NCT01393899|144180849|SUPERIORITY_OR_OTHER||Difference in Percentage|1.61|||||TWO_SIDED|80.0|-11.33|14.55||||||Week 20||14.55|-11.33|
72328122|NCT01393899|144180849|SUPERIORITY_OR_OTHER||Difference in Percentage|8.64|||||TWO_SIDED|80.0|-4.36|21.64||||||Week 26||21.64|-4.36|
72328123|NCT01393899|144180849|SUPERIORITY_OR_OTHER||Difference in Percentage|5.76|||||TWO_SIDED|80.0|-8.04|19.56||||||Week 4||19.56|-8.04|
72328124|NCT01393899|144180849|SUPERIORITY_OR_OTHER||Difference in Percentage|-8.08|||||TWO_SIDED|80.0|-21.83|5.66||||||Week 8||5.66|-21.83|
72328125|NCT01393899|144180849|SUPERIORITY_OR_OTHER||Difference in Percentage|1.55|||||TWO_SIDED|80.0|-11.63|14.73||||||Week 12||14.73|-11.63|
72328126|NCT01393899|144180849|SUPERIORITY_OR_OTHER||Difference in Percentage|8.58|||||TWO_SIDED|80.0|-4.64|21.81||||||Week 20||21.81|-4.64|
72328127|NCT01393899|144180849|SUPERIORITY_OR_OTHER||Difference in Percentage|13.29|||||TWO_SIDED|80.0|0.15|26.43||||||Week 26||26.43|0.15|
72328128|NCT01393899|144180850|SUPERIORITY_OR_OTHER||Difference in Percentage|6.57|||||TWO_SIDED|80.0|-8.63|21.78||||||Week 4||21.78|-8.63|
72328129|NCT01393899|144180850|SUPERIORITY_OR_OTHER||Difference in Percentage|0.29|||||TWO_SIDED|80.0|-16.63|17.2||||||Week 8||17.20|-16.63|
72328130|NCT01393899|144180850|SUPERIORITY_OR_OTHER||Difference in Percentage|24.29|||||TWO_SIDED|80.0|7.19|41.38||||||Week 12||41.38|7.19|
72328131|NCT01393899|144180850|SUPERIORITY_OR_OTHER||Difference in Percentage|6.86|||||TWO_SIDED|80.0|-10.32|24.03||||||Week 20||24.03|-10.32|
72328132|NCT01393899|144180850|SUPERIORITY_OR_OTHER||Difference in Percentage|11.29|||||TWO_SIDED|80.0|-5.22|27.79||||||Week 26||27.79|-5.22|
72328133|NCT01393899|144180850|SUPERIORITY_OR_OTHER||Difference in Percentage|8.77|||||TWO_SIDED|80.0|-6.41|23.95||||||Week 4||23.95|-6.41|
72328134|NCT01393899|144180850|SUPERIORITY_OR_OTHER||Difference in Percentage|-14.0|||||TWO_SIDED|80.0|-31.59|3.59||||||Week 8||3.59|-31.59|
72328135|NCT01393899|144180850|SUPERIORITY_OR_OTHER||Difference in Percentage|2.31|||||TWO_SIDED|80.0|-15.35|19.97||||||Week 12||19.97|-15.35|
72328136|NCT01393899|144180850|SUPERIORITY_OR_OTHER||Difference in Percentage|10.15|||||TWO_SIDED|80.0|-7.41|27.71||||||Week 20||27.71|-7.41|
72328137|NCT01393899|144180850|SUPERIORITY_OR_OTHER||Difference in Percentage|22.0|||||TWO_SIDED|80.0|4.96|39.04||||||Week 26||39.04|4.96|
72328138|NCT01393899|144180851|SUPERIORITY_OR_OTHER||Difference in Percentage|1.83|||||TWO_SIDED|80.0|-9.75|13.4||||||||13.40|-9.75|
72328139|NCT01393899|144180851|SUPERIORITY_OR_OTHER||Difference in Percentage|18.11|||||TWO_SIDED|80.0|5.57|30.64||||||||30.64|5.57|
72328140|NCT01393899|144180852|SUPERIORITY_OR_OTHER||Difference in Percentage|-7.75|||||TWO_SIDED|80.0|-20.39|4.88||||||||4.88|-20.39|
72328141|NCT01393899|144180852|SUPERIORITY_OR_OTHER||Difference in Percentage|17.83|||||TWO_SIDED|80.0|4.33|31.33||||||||31.33|4.33|
72328142|NCT01393899|144180854|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-30.26|||=|0.0637|TWO_SIDED|80.0|-51.1|-9.42|||Linear mixed-effects model||Parameter Type: Adjusted Mean Difference|Week 4||-9.42|-51.10|=0.0637
72328143|NCT01393899|144180854|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-21.06|||=|0.3054|TWO_SIDED|80.0|-47.43|5.31|||Linear mixed-effects model||Parameter Type: Adjusted Mean Difference|Week 8||5.31|-47.43|=0.3054
72328144|NCT01393899|144180854|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-42.52|||=|0.1316|TWO_SIDED|80.0|-78.57|-6.48|||Linear mixed-effects model||Parameter Type: Adjusted Mean Difference|Week 12||-6.48|-78.57|=0.1316
72328145|NCT01393899|144180854|SUPERIORITY_OR_OTHER||Adjusted Mean Dofference|-18.01|||=|0.5704|TWO_SIDED|80.0|-59.01|22.99|||Linear mixed-effects model||Parameter Type: Adjusted Mean Difference|Week 20||22.99|-59.01|=0.5704
72328146|NCT01393899|144180854|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-6.0|||=|0.8389|TWO_SIDED|80.0|-44.22|32.21|||Linear mixed-effects model||Parameter Type: Adjusted Mean Difference|Week 26||32.21|-44.22|=0.8389
72328147|NCT01393899|144180854|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-23.56|||=|0.1452|TWO_SIDED|80.0|-44.27|-2.85|||Linear mixed-effects model||Parameter Type: Adjusted Mean Difference|Week 4||-2.85|-44.27|=0.1452
72328148|NCT01393899|144180854|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-9.61|||=|0.6399|TWO_SIDED|80.0|-36.03|16.81|||Linear mixed-effects model||Parameter Type: Adjusted Mean Difference|Week 8||16.81|-36.03|=0.6399
72328149|NCT01393899|144180854|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-37.0|||=|0.1949|TWO_SIDED|80.0|-73.57|-0.42|||Linear mixed-effects model||Parameter Type: Adjusted Mean Difference|Week 12||-0.42|-73.57|=0.1949
72328150|NCT01393899|144180854|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-47.74|||=|0.1358|TWO_SIDED|80.0|-88.62|-6.87|||Linear mixed-effects model||Parameter Type: Adjusted Mean Difference|Week 20||-6.87|-88.62|=0.1358
72328151|NCT01393899|144180854|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-50.38|||=|0.089|TWO_SIDED|80.0|-88.03|-12.72|||Linear mixed-effects model||Parameter Type: Adjusted Mean Difference|Week 26||-12.72|-88.03|=0.0890
72328152|NCT01393899|144180855|SUPERIORITY_OR_OTHER||Difference in Percentage|-7.44|||||TWO_SIDED|80.0|-16.14|1.26||||||Week 4||1.26|-16.14|
72328153|NCT01393899|144180855|SUPERIORITY_OR_OTHER||Difference in Percentage|-7.43|||||TWO_SIDED|80.0|-18.27|3.41||||||Week 8||3.41|-18.27|
72328154|NCT01393899|144180855|SUPERIORITY_OR_OTHER||Difference in Percentage|-12.48|||||TWO_SIDED|80.0|-25.68|0.72||||||Week 12||0.72|-25.68|
72328155|NCT01393899|144180855|SUPERIORITY_OR_OTHER||Difference in Percentage|-12.73|||||TWO_SIDED|80.0|-26.81|1.34||||||Week 20||1.34|-26.81|
72328156|NCT01393899|144180855|SUPERIORITY_OR_OTHER||Difference in Percentage|-18.9|||||TWO_SIDED|80.0|-39.52|1.72||||||Week 26||1.72|-39.52|
72328157|NCT01393899|144180855|SUPERIORITY_OR_OTHER||Difference in Percentage|-2.96|||||TWO_SIDED|80.0|-12.39|6.48||||||Week 4||6.48|-12.39|
72328158|NCT01393899|144180855|SUPERIORITY_OR_OTHER||Difference in Percentage|1.61|||||TWO_SIDED|80.0|-10.14|13.36||||||Week 8||13.36|-10.14|
72328159|NCT01393899|144180855|SUPERIORITY_OR_OTHER||Difference in Percentage|-8.09|||||TWO_SIDED|80.0|-21.54|5.36||||||Week 12||5.36|-21.54|
72328160|NCT01393899|144180855|SUPERIORITY_OR_OTHER||Difference in Percentage|-12.9|||||TWO_SIDED|80.0|-26.99|1.19||||||Week 20||1.19|-26.99|
72328161|NCT01393899|144180855|SUPERIORITY_OR_OTHER||Difference in Percentage|-26.28|||||TWO_SIDED|80.0|-46.54|-6.02||||||Week 26||-6.02|-46.54|
72328162|NCT01393899|144180856|SUPERIORITY_OR_OTHER||Difference in Percentage|10.61|||||TWO_SIDED|80.0|-11.44|32.66||||||||32.66|-11.44|
72328163|NCT01393899|144180856|SUPERIORITY_OR_OTHER||Difference in Percentage|16.67|||||TWO_SIDED|80.0|-4.15|37.49||||||||37.49|-4.15|
72328164|NCT01393899|144180858|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.93|||<|0.0001|TWO_SIDED|95.0|-1.34|-0.53|||Linear mixed-effects model||Parameter Type: Adjusted Mean Difference|Week 4||-0.53|-1.34|<0.0001
72328165|NCT01393899|144180858|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.76|||=|0.0024|TWO_SIDED|95.0|-1.24|-0.28|||Linear mixed-effects model||Parameter Type: Adjusted Mean Difference|Week 8||-0.28|-1.24|=0.0024
72328166|NCT01393899|144180858|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.75|||=|0.0044|TWO_SIDED|95.0|-1.26|-0.24|||Linear mixed-effects model||Parameter Type: Adjusted Mean Difference|Week 12||-0.24|-1.26|=0.0044
72328167|NCT01393899|144180858|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.56|||=|0.0582|TWO_SIDED|95.0|-1.13|0.02|||Linear mixed-effects model||Parameter Type: Adjusted Mean Difference|Week 20||0.02|-1.13|=0.0582
72328168|NCT01393899|144180858|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.61|||=|0.0865|TWO_SIDED|95.0|-1.31|0.09|||Linear mixed-effects model||Parameter Type: Adjusted Mean Difference|Week 26||0.09|-1.31|=0.0865
72328169|NCT01393899|144180858|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.92|||<|0.0001|TWO_SIDED|95.0|-1.32|-0.52|||Linear mixed-effects model||Parameter Type: Adjusted Mean Difference|Week 4||-0.52|-1.32|<0.0001
72328170|NCT01393899|144180858|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.92|||=|0.0002|TWO_SIDED|95.0|-1.4|-0.45|||Linear mixed-effects model||Parameter Type: Adjusted Mean Difference|Week 8||-0.45|-1.40|=0.0002
72328171|NCT01393899|144180858|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.23|||<|0.0001|TWO_SIDED|95.0|-1.75|-0.71|||Linear mixed-effects model||Parameter Type: Adjusted Mean Difference|Week 12||-0.71|-1.75|<0.0001
72328172|NCT01393899|144180858|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.3|||<|0.0001|TWO_SIDED|95.0|-1.87|-0.74|||Linear mixed-effects model||Parameter Type: Adjusted Mean Difference|Week 20||-0.74|-1.87|<0.0001
72328173|NCT01393899|144180858|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.62|||<|0.0001|TWO_SIDED|95.0|-2.3|-0.95|||Linear mixed-effects model||Parameter Type: Adjusted Mean Difference|Week 26||-0.95|-2.30|<0.0001
72328174|NCT01393899|144180860|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.39|||=|0.0566|TWO_SIDED|95.0|-0.79|0.01|||Linear mixed-effects model||Parameter Type: Adjusted Mean Difference|Week 8||0.01|-0.79|=0.0566
72328175|NCT01393899|144180860|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.21|||=|0.3144|TWO_SIDED|95.0|-0.61|0.2|||Linear mixed-effects model||Parameter Type: Adjusted Mean Difference|Week 12||0.20|-0.61|=0.3144
72420345|NCT00335452|144352095|SUPERIORITY_OR_OTHER||Relative Risk Reduction (%)|17.6||||0.0262|TWO_SIDED|95.0|2.2|30.5||The a priori threshold for statistical significance is ≤0.05.|Log Rank|Two-sided stratified by qualifying condition (UA/NSTEMI or STEMI) log-rank test.|The relative risk reduction (high dose treatment regimen (600/150/75 mg) versus standard treatment regimen (300/75/75 mg)) is estimated using a stratified Cox proportional hazards model controlling for qualifying condition.|||30.5|2.2|0.0262
72328176|NCT01393899|144180860|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.56|||=|0.0434|TWO_SIDED|95.0|-1.1|-0.02|||Linear mixed-effects model||Parameter Type: Adjusted Mean Difference|Week 26||-0.02|-1.10|=0.0434
72420346|NCT00335452|144352095|SUPERIORITY_OR_OTHER|||||||0.0355||95.0||||The a priori threshold for statistical significance is ≤0.05.|Chi-squared|Interaction chi-squared test of the Cox proportional hazards model.||||||0.0355
72328177|NCT01393899|144180860|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.57|||=|0.005|TWO_SIDED|95.0|-0.96|-0.18|||Linear mixed-effects model||Parameter Type: Adjusted Mean Difference|Week 8||-0.18|-0.96|=0.0050
72328178|NCT01393899|144180860|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.66|||=|0.0017|TWO_SIDED|95.0|-1.06|-0.25|||Linear mixed-effects model||Parameter Type: Adjusted Mean Difference|Week 12||-0.25|-1.06|=0.0017
72328179|NCT01393899|144180860|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.2|||<|0.0001|TWO_SIDED|95.0|-1.72|-0.67|||Linear mixed-effects model||Parameter Type: Adjusted Mean Difference|Week 26||-0.67|-1.72|<0.0001
72328180|NCT02520388|144180882|SUPERIORITY|||||||0.05|||||||Mixed model repeated measures analysis|||||||0.05
72328181|NCT02520388|144180883|SUPERIORITY|||||||0.05|||||||Mixed model repeated measures analysis|||||||0.05
72328182|NCT03035864|144180897|SUPERIORITY||difference in LS means|-0.11|||=|0.974|TWO_SIDED|95.0|-6.85|6.63|||ANCOVA|||Frequency statistical analysis||6.63|-6.85|=0.974
72328183|NCT03035864|144180897|SUPERIORITY||Difference in least square means|2.88|||=|0.399|TWO_SIDED|95.0|-3.85|9.61|||ANCOVA|||Statistical analysis related to severity||9.61|-3.85|=0.399
72328184|NCT03035864|144180898|SUPERIORITY||difference in least square means|0.04|||=|0.214|TWO_SIDED|95.0|-0.02|0.1|||ANCOVA|||||0.10|-0.02|=0.214
72328185|NCT03035864|144180902|SUPERIORITY||difference in least square means|-0.43|||=|0.881|TWO_SIDED|95.0|-6.13|5.27|||ANCOVA|||Frequency - week 4||5.27|-6.13|=0.881
72328186|NCT03035864|144180902|SUPERIORITY||difference in least square means|-0.31|||=|0.926|TWO_SIDED|95.0|-6.96|6.33|||ANCOVA|||Frequency - week 8||6.33|-6.96|=0.926
72328187|NCT03035864|144180902|SUPERIORITY||difference in least square means|-2.29|||=|0.426|TWO_SIDED|95.0|-7.97|3.38|||ANCOVA|||Frequency - Week 12||3.38|-7.97|=0.426
72328188|NCT03035864|144180902|SUPERIORITY||Difference in least square means|0.62|||=|0.828|TWO_SIDED|95.0|-5.04|6.29|||ANCOVA|||Severity - Week 4||6.29|-5.04|=0.828
72328189|NCT03035864|144180902|SUPERIORITY||difference in least square means|2.86|||=|0.394|TWO_SIDED|95.0|-3.75|9.47|||ANCOVA|||Severity - Week 8||9.47|-3.75|=0.394
72328190|NCT03035864|144180902|SUPERIORITY||difference in least square means|-1.49|||=|0.552|TWO_SIDED|95.0|-6.41|3.44|||ANCOVA|||Severeity - Week 12||3.44|-6.41|=0.552
72328191|NCT01890265|144180904|SUPERIORITY||LS mean difference|4.33|||=|0.0331|TWO_SIDED|95.0|0.35|8.3||The analysis of the change from Baseline to Week 48 in FVC (% predicted) was based on the random coefficient regression model based on observed cases.|Random coefficient regression|||The absolute LS mean treatment difference (pamrevlumab - placebo) for change from Baseline to Week 48 in FVC (% predicted) is presented.||8.3|0.35|= 0.0331
72328192|NCT01890265|144180905|SUPERIORITY||LS mean difference|-1.8|||=|0.0236|TWO_SIDED|95.0|-3.3|-0.2|||ANCOVA with MI|||The absolute LS mean treatment difference (pamrevlumab - placebo) for change from Baseline to Week 24 in QLF score is presented.||-0.2|-3.3|= 0.0236
72328193|NCT01890265|144180905|SUPERIORITY||LS mean difference|-3.2|||=|0.0729|TWO_SIDED|95.0|-6.6|0.3|||ANCOVA with MI|||The absolute LS mean treatment difference (pamrevlumab - placebo) for change from Baseline to Week 48 in QLF score is presented.||0.3|-6.6|= 0.0729
72328194|NCT01890265|144180906|SUPERIORITY||Absolute difference|-21.4|||=|0.0133|TWO_SIDED|95.0|-36.6|-6.2|||Regression, Logistic|||The absolute treatment difference (pamrevlumab - placebo) for percentage of participants with IPF progression at Week 48 is presented.||-6.2|-36.6|= 0.0133
72420347|NCT00335452|144352096|SUPERIORITY_OR_OTHER||Relative Risk Reduction (%)|14.7||||0.0332|TWO_SIDED|95.0|1.2|26.3||The a priori threshold for statistical significance is ≤0.05.|Log Rank|Two-sided stratified by ASA dose level (low or high) and qualifying condition (UA/NSTEMI or STEMI) Log-rank test. No adjustment was made.|The relative risk reduction (high dose treatment regimen (600/150/75 mg) versus standard treatment regimen (300/75/75 mg)) is estimated using a stratified Cox proportional hazards model controlling for ASA dose level and qualifying condition.|||26.3|1.2|0.0332
72420348|NCT00335452|144352097|SUPERIORITY_OR_OTHER|||||||0.945||95.0||||The a priori threshold for statistical significance is ≤0.05.|Regression, Logistic|Logistic regression model including a term for Clopidogrel treatment regimen (300/75/75 mg or 600/150/75 mg).||||||0.945
72420349|NCT00335452|144352098|SUPERIORITY_OR_OTHER||Relative Risk Reduction (%)|32.6||||0.0004|TWO_SIDED|95.0|16.2|45.8||The a priori threshold for statistical significance is ≤0.05.|Log Rank|Two-sided stratified by ASA dose level (low or high) and qualifying condition (UA/NSTEMI or STEMI) log-rank test.|The relative risk reduction (high dose treatment regimen (600/150/75 mg) versus standard treatment regimen (300/75/75 mg)) is estimated using a stratified Cox proportional hazards model controlling for ASA dose level and qualifying condition.|||45.8|16.2|0.0004
72420350|NCT01904864|144352099|SUPERIORITY||Mean Difference (Net)|1.0|||<|0.001|TWO_SIDED|95.0|0.4|1.6|||Regression, Linear||Change at 12 weeks compared|||1.6|0.4|<0.001
72420351|NCT02093663|144352140|OTHER||Odds Ratio (OR)|3.21||||0.039|TWO_SIDED|95.0|1.04|9.88|||Uncorrected Chi-squared Test|||This study is not powered to detect differences between treatment groups and other sensitivity analysis (last observation carried forward \[LOCF\] and complete case) intended to examine the robustness of the treatment estimate. This was an estimation study, and p-values were presented as descriptive statistics.||9.88|1.04|0.039
72420352|NCT02093663|144352141|OTHER||Odds Ratio (OR)|0.99||||0.981|TWO_SIDED|95.0|0.42|2.34||P-value were based on a Cochran-Mantel-Haenszel test stratified by prior response status.|Cochran-Mantel-Haenszel|||This study is not powered to detect differences between treatment groups and other sensitivity analysis (LOCF and complete case) intended to examine the robustness of the treatment estimate. This was an estimation study, and p-value s were presented as descriptive statistics.||2.34|0.42|0.981
72420353|NCT02093663|144352142|OTHER||Difference in proportions|50.0||||0.4|TWO_SIDED|95.0|-19.3|100.0||P-value was calculated based on Fisher's exact test.|Fisher Exact|||This study is not powered to detect differences between treatment groups and other sensitivity analysis (LOCF and complete case) intended to examine the robustness of the treatment estimate. This was an estimation study, and p-values were presented as descriptive statistics.||100.0|-19.3|0.400
72420354|NCT02093663|144352143|OTHER||Difference in proportions|50.0||||0.333|TWO_SIDED|95.0|-19.3|100.0||P-value was based on a Fisher's exact test.|Fisher Exact|||This study is not powered to detect differences between treatment groups and other sensitivity analysis (LOCF and complete case) intended to examine the robustness of the treatment estimate.||100.0|-19.3|0.333
72420355|NCT02093663|144352144|OTHER||Difference in Least squares Mean|-5.4||||0.168|TWO_SIDED|95.0|-13.1|2.4||P-value is based on an analysis of covariance (ANCOVA) including treatment arm as a factor and baseline DUCS score as a covariate.|ANCOVA|||This study is not powered to detect differences between treatment groups and other sensitivity analysis (LOCF and complete case) intended to examine the robustness of the treatment estimate. This was an estimation study, and p-values were presented as descriptive statistics.||2.4|-13.1|0.168
72420356|NCT02093663|144352145|OTHER||Difference in proportions|24.5||||0.131|TWO_SIDED|95.0|-1.6|50.6||P-value was based on a continuity-corrected chi-squared test. PUCAI Score was compared between treatment arms using a continuity corrected chi-squared test. Expected cell counts are very low (\< 5), then Fisher's Exact Test is alternative method.|Chi-squared, Corrected|||This study is not powered to detect differences between treatment groups and other sensitivity analysis (LOCF and complete case) intended to examine the robustness of the treatment estimate. This was an estimation study, and p-values were presented as descriptive statistics.||50.6|-1.6|0.131
72420357|NCT02093663|144352146|OTHER||Difference in Proportions Percentage|-6.5||||0.539|TWO_SIDED|95.0|-25.3|12.3||P-value is based on a CMH test adjusted by prior response status.|Cochran-Mantel-Haenszel|||This study is not powered to detect differences between treatment groups and other sensitivity analysis (LOCF and complete case) intended to examine the robustness of the treatment estimate. This was an estimation study, and p-values were presented as descriptive statistics.||12.3|-25.3|0.539
72420358|NCT02093663|144352147|OTHER||Difference in proportions|-16.2||||0.129|TWO_SIDED|95.0|-36.0|3.6||P-value was based on a Cochran-Mantel-Haenszel (CMH) test adjusted by prior response status.|Cochran-Mantel-Haenszel|||This study is not powered to detect differences between treatment groups and other sensitivity analysis (LOCF and complete case) intended to examine the robustness of the treatment estimate. This was an estimation study, and p-values were presented as descriptive statistics.||3.6|-36.0|0.129
72420359|NCT02093663|144352148|OTHER||Difference in Least squares Mean|3.0||||0.182|TWO_SIDED|95.0|-1.4|7.4||P-value was based on an analysis of covariance (ANCOVA) including treatment arm and with prior response status.|ANCOVA|||This study is not powered to detect differences between treatment groups and other sensitivity analysis (LOCF and complete case) intended to examine the robustness of the treatment estimate. This was an estimation study, and p-values were presented as descriptive statistics.||7.4|-1.4|0.182
72420360|NCT02093663|144352149|OTHER||Difference in proportions|-9.0||||0.194|TWO_SIDED|95.0|-29.1|11.0||P-value was based on a CMH test adjusted by prior response status. Participants with remission (PUCAI \<10) at double-blind maintenance phase at Week 26 was compared between treatment arms using a CMH test stratifying by Week 8 responder status.|Cochran-Mantel-Haenszel|||This study is not powered to detect differences between treatment groups and other sensitivity analysis (LOCF and complete case) intended to examine the robustness of the treatment estimate. This was an estimation study, and p-values were presented as descriptive statistics.||11.0|-29.1|0.194
72420361|NCT00508404|144352150|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.12|||||TWO_SIDED|95.0|1.02|4.45|||||The odds ratio is defined as the odds of having an objective response in the KRAS Wild-type group relative to the odds in the KRAS Mutant group.|||4.45|1.02|
72328195|NCT00809926|144180911|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-1.6||||0.295|TWO_SIDED|95.0|-4.61|1.4|||ANCOVA|||||1.40|-4.61|0.295
72420362|NCT00508404|144352151|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.86|||||TWO_SIDED|95.0|0.88|3.93|||||The odds ratio is defined as the odds of having an objective response in the KRAS Wild-type group relative to the odds in the KRAS Mutant group.|||3.93|0.88|
72420363|NCT00508404|144352152|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.11|||||TWO_SIDED|95.0|0.3|3.89|||||The odds ratio is defined as the odds of having an objective response in the KRAS Wild-type group relative to the odds in the KRAS Mutant group.|||3.89|0.30|
72420364|NCT00508404|144352153|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.283|||||TWO_SIDED|95.0|0.13|0.614|||||Hazard ratio is presented as Wild-type KRAS:Mutant KRAS. A value \< 1.0 indicates a lower average event rate and longer time to event for Wild-type KRAS relative to Mutant KRAS.|||0.614|0.130|
72420365|NCT00508404|144352154|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.642|||||TWO_SIDED|95.0|0.99|2.721|||||Hazard ratio is presented as Wild-type KRAS:Mutant KRAS. A value \< 1.0 indicates a lower average event rate and longer time to event for Wild-type KRAS relative to Mutant KRAS.|||2.721|0.990|
72420366|NCT00508404|144352155|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.464|||||TWO_SIDED|95.0|0.306|0.703|||||Hazard ratio presented as Wild-type KRAS:Mutant KRAS. A value \< 1.0 indicates a lower average event rate and longer time to event for Wild-type KRAS relative to Mutant KRAS.|||0.703|0.306|
72420367|NCT00508404|144352156|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.395|||||TWO_SIDED|95.0|0.252|0.618|||||Hazard ratio is presented as Wild-type KRAS:Mutant KRAS. A value \< 1.0 indicates a lower average event rate and longer time to event for Wild-type KRAS relative to Mutant KRAS.|||0.618|0.252|
72420368|NCT00508404|144352157|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.756|||||TWO_SIDED|95.0|0.4|1.43|||||Hazard ratio is presented as Wild-type KRAS:Mutant KRAS. A value \< 1.0 indicates a lower average event rate and longer time to event for Wild-type KRAS relative to Mutant KRAS.|||1.430|0.400|
72420369|NCT00508404|144352158|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.71|||||TWO_SIDED|95.0|0.503|1.002|||||Hazard ratio is presented as Wild-type KRAS:Mutant KRAS. A value \< 1.0 indicates a lower average event rate and longer time to event for Wild-type KRAS relative to Mutant KRAS.|||1.002|0.503|
72420370|NCT00508404|144352160|SUPERIORITY_OR_OTHER_LEGACY||Difference in rates|8.34|||||TWO_SIDED|95.0|-4.01|19.08||||||||19.08|-4.01|
72420371|NCT03662074|144352161|OTHER||||||||||||||||||The pre-specified analysis plan as per the protocol is to proceed to the second stage of recruitment for additional participants if the response proportion exceeds the historical control of 10%.|||
72420372|NCT00643123|144352185|OTHER||Mean Difference (Final Values)|2.9|STANDARD_ERROR_OF_MEAN|2.3||0.45|TWO_SIDED||||||t-test, 2 sided|||||||.45
72420373|NCT01591382|144352195|SUPERIORITY_OR_OTHER|||||||0.0241||||||A P-value of \<0.05 was indicative of statistical significance.|Wilcoxon (Mann-Whitney)|||||||0.0241
72420374|NCT01591382|144352196|SUPERIORITY_OR_OTHER|||||||0.4102||||||A P-value of \<0.05 was indicative of statistical significance.|Wilcoxon (Mann-Whitney)|||||||0.4102
72420375|NCT01591382|144352197|SUPERIORITY_OR_OTHER|||||||0.1085||||||A P-value of \<0.05 was indicative of statistical significance.|Wilcoxon (Mann-Whitney)|||||||0.1085
72420376|NCT01591382|144352198|SUPERIORITY_OR_OTHER|||||||0.748|||||||Wilcoxon (Mann-Whitney)|||||||0.7480
72420377|NCT00855062|144352210|SUPERIORITY_OR_OTHER||Slope|-0.026|STANDARD_ERROR_OF_MEAN|0.248||0.37|TWO_SIDED|95.0|-0.512|0.46||The p-value was not adjusted for multiple comparisons.|Regression, Linear|||"The null hypothesis was that the 24-week changes of U NP Sum between the minocycline and placebo groups are the same.~The sample size calculation showed that 100 (50 participants in each group) were required to detect the clinically meaningful difference of 0.5 with 85% power, 0.05 Type I error, two-sample and two-sided test."||0.460|-0.512|0.370
72420378|NCT00855062|144352212|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.053||||0.613|TWO_SIDED|95.0|0.043|0.062||The p-value is not adjusted for multiple comparisons.|Fisher Exact|||"The null hypothesis is that the percentage of participants feeling better in the minocycline group after 24 week treatment is the same as the one in the placebo group."||0.062|0.043|0.613
72420379|NCT00855062|144352213|SUPERIORITY_OR_OTHER|||||||0.661||95.0||||The p-value is not adjusted for multiple comparisons.|Log Rank|||The null hypothesis is that the survival curve for the first Grade ≥ 2 toxicity and/or sign and symptoms in the minocycline group is the same as the one in the placebo group.||||0.661
72420380|NCT00855062|144352214|SUPERIORITY_OR_OTHER|||||||0.941||95.0||||The p-value is not adjusted for multiple comparisons.|Log Rank|||The null hypothesis is that the 48-week survival curve for the first Grade ≥ 2 toxicity and/or sign and symptoms in the minocycline group is the same as the one in the placebo group.||||0.941
72420381|NCT00855062|144352215|SUPERIORITY_OR_OTHER||Mean Difference (Net)|8.11|STANDARD_ERROR_OF_MEAN|17.63||0.647|TWO_SIDED|95.0|-27.23|43.45||The p-value is not adjusted for multiple comparisons.|Regression, Linear|The model was adjusted for the baseline CD4 counts.||The null hypothesis is that the mean 24-week change of CD4 cell counts in the minocycline group is the same as the one in the placebo group.||43.45|-27.23|0.647
72420382|NCT00855062|144352216|SUPERIORITY_OR_OTHER||Mean Difference (Net)|7.77|STANDARD_ERROR_OF_MEAN|32.51||0.813|TWO_SIDED|95.0|-59.07|74.6||The p-value was not adjusted for multiple comparisons.|Regression, Linear|The model was adjusted for the baseline CD4 counts.||The null hypothesis is that the mean 48-week change in CD4 cell counts in the minocycline group is the same as the one in the placebo group.||74.60|-59.07|0.813
72420383|NCT00855062|144352217|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.28|STANDARD_ERROR_OF_MEAN|0.82||0.764||95.0|0.26|6.34||The p-value is not adjusted for multiple comparisons.|Regression, Logistic|"The model was not adjusted for any covariate (due to small number of being better in both groups."||"The null hypothesis is that the percentage of being better at week 24 compared to baseline in the minocycline group is the same as the one in the placebo group."||6.34|0.26|0.764
72420384|NCT00855062|144352218|SUPERIORITY_OR_OTHER|||||||0.766||95.0||||The p-value is not adjusted for multiple comparisons.|Kruskal-Wallis|The chi-square score was 0.024 and the degree of freedom was 1.||The null hypothesis is that the median log10-transformed HIV RNA viral loads in the minocycline group is the same as the one in the placebo group.||||0.766
72420385|NCT00855062|144352219|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.19|STANDARD_ERROR_OF_MEAN|1.79||0.915|TWO_SIDED|95.0|-3.4|3.78||The p-value is not adjusted for multiple comparisons.|Regression, Linear|The model was adjusted for the baseline CES-D and MSK scores.||The null hypothesis is that the mean 24-week change of CES-D score in the minocycline group is the same as the one in the placebo group.||3.78|-3.40|0.915
72420386|NCT04252742|144352260|SUPERIORITY||LSM difference|-7.95|||<|0.001|TWO_SIDED|95.0|-11.45|-4.46||Nominal p-value is presented without multiplicity adjustment.|Mixed Models Analysis|Treatment, visit, treatment-by-visit interaction, and baseline value as covariates.|Erenumab 140 mg SC Q4W - Placebo|||-4.46|-11.45|< 0.001
72420387|NCT04252742|144352261|SUPERIORITY||LSM difference|-7.36|||<|0.001|TWO_SIDED|95.0|-10.8|-3.92||Nominal p-value is presented without multiplicity adjustment.|Mixed Models Analysis|Treatment, visit, treatment-by-visit interaction, and baseline value as covariates.|Erenumab 140 mg SC Q4W - Placebo|||-3.92|-10.80|< 0.001
72420388|NCT04252742|144352262|SUPERIORITY||LSM difference|-7.1|||<|0.001|TWO_SIDED|95.0|-10.34|-3.87||Nominal p-value is presented without multiplicity adjustment|Mixed Models Analysis|Treatment, visit, treatment-by-visit interaction, and baseline value as covariates|Erenumab 140 mg SC Q4W - Placebo|||-3.87|-10.34|< 0.001
72420389|NCT04252742|144352263|SUPERIORITY||LSM difference|-7.05|||<|0.001|TWO_SIDED|95.0|-10.76|-3.34||Nominal p-value is presented without multiplicity adjustment|Mixed Models Analysis|Treatment, visit, treatment-by-visit interaction, and baseline value as covariates|Erenumab 140 mg SC Q4W - Placebo|||-3.34|-10.76|< 0.001
72420390|NCT04252742|144352264|SUPERIORITY||LSM difference|-6.82|||<|0.001|TWO_SIDED|95.0|-10.37|-3.27||Nominal p-value is presented without multiplicity adjustment|Mixed Models Analysis|Treatment, visit, treatment-by-visit interaction, and baseline value as covariates|Erenumab 140 mg SC Q4W - Placebo|||-3.27|-10.37|< 0.001
72420391|NCT04252742|144352265|SUPERIORITY||LSM difference|-1.07||||0.013|TWO_SIDED|95.0|-1.92|-0.22||Nominal p-value is presented without multiplicity adjustment.|Mixed Models Analysis|Treatment, visit, treatment-by-visit interaction, and baseline value as covariates.|Erenumab 140 mg SC Q4W - Placebo|||-0.22|-1.92|0.013
72420392|NCT04252742|144352266|SUPERIORITY||LSM difference|-0.48||||0.011|TWO_SIDED|95.0|-0.85|-0.11||Nominal p-value is presented without multiplicity adjustment|Mixed Models Analysis|Treatment, visit, treatment-by-visit interaction, and baseline value as covariates|Erenumab 140 mg SC Q4W - Placebo|||-0.11|-0.85|0.011
72420393|NCT03371082|144352313|EQUIVALENCE|The limits of the lower and upper equivalence margin were -11.3 and 11.3, respectively.|Risk Difference (RD)|0.6|STANDARD_ERROR_OF_MEAN|3.63|||TWO_SIDED|90.0|-5.4|6.5|||||The asymptotic standard error was planned and is reported above.|This is a two-arm study.||6.5|-5.4|
72420394|NCT01064297|144352325|SUPERIORITY_OR_OTHER||Wilson Score with Continuity Correction|2.2||||||95.0|1.6|3.1|||||The percentage of infants with MBDs was calculated as: the number of outcomes with MBDs divided by (the number of outcomes with MBDs + the number of live births without defects).|||3.1|1.6|
72420395|NCT01064297|144352325|SUPERIORITY_OR_OTHER||Wilson Score with Continuity Correction|4.2||||||95.0|1.4|11.0|||||The percentage of infants with MBDs was calculated as: the number of outcomes with MBDs divided by (the number of outcomes with MBDs + the number of live births without defects).|||11.0|1.4|
72420396|NCT01064297|144352325|SUPERIORITY_OR_OTHER||Wilson Score with Continuity Correction|2.4||||||95.0|1.7|3.3|||||The percentage of infants with MBDs was calculated as: the number of outcomes with MBDs divided by (the number of outcomes with MBDs + the number of live births without defects).|||3.3|1.7|
72420397|NCT01064297|144352326|SUPERIORITY_OR_OTHER||Wilson Score with Continuity Correction|10.7||||||95.0|6.4|17.0||||||||17.0|6.4|
72420398|NCT01064297|144352326|SUPERIORITY_OR_OTHER||Wilson Score with Continuity Correction|9.3||||||95.0|5.5|15.2|||||The percentage of infants with MBDs was calculated as: the number of outcomes with MBDs divided by (the number of outcomes with MBDs + the number of live births without defects).|||15.2|5.5|
72420399|NCT01064297|144352327|SUPERIORITY_OR_OTHER||Wilson Score with Continuity Correction|2.8||||||95.0|1.5|5.0||||||||5.0|1.5|
72420400|NCT01064297|144352327|SUPERIORITY_OR_OTHER||Wilson Score with Continuity Correction|2.8||||||95.0|1.6|4.9|||||The percentage of infants with MBDs was calculated as: the number of outcomes with MBDs divided by (the number of outcomes with MBDs + the number of live births without defects).|||4.9|1.6|
72420401|NCT02597907|144352347|OTHER||||||<|0.05|||||||Fisher Exact|||||||<0.05
72420402|NCT05050578|144352367|NON_INFERIORITY|Noninferiority in distance VA was declared if upper confidence limit was less than 0.05.|Least Squares Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.003|||ONE_SIDED|95.0||0.0||Since a noninferiority hypothesis is being tested, a p-value is not applicable. Confidence limit is being reported and compared to the noninferiority margin.|||LSM results based on mixed effects repeated measures model with both fixed (lens, visit, lens by visit interaction, period, sequence) and random (subject) effects. Difference = LID18869 minus AOHG. Sign is retained with the rounded value.|||0.00||
72420403|NCT03386032|144352377|SUPERIORITY||||||<|0.05|||||||ANCOVA|Model adjusted means.||Change from baseline in variables were analyzed separately using a mixed model for repeated measures with Subject nested within treatment (random effect), and Treatment, Week, Treatment-by-Week, Age \& Baseline (fixed effects). Last Observation was Carried Forward (LOCF) for drops. Sporadic missing data were left missing.||||<0.05
72420404|NCT03386032|144352378|SUPERIORITY||||||<|0.05|||||||ANCOVA|Model adjusted means. Last Observation was Carried Forward (LOCF) for drops. Sporadic missing data were left miss||"Change from baseline in variables were analyzed separately using a mixed model for repeated measures with Subject nested within treatment (random effect), and Treatment, Week, Treatment-by-Week, Age \& Baseline (fixed effects). Last Observation was Carried Forward (LOCF) for drops. Sporadic missing data were left missing.~Significance level: 0.05 (2-sided)"||||<0.05
72420405|NCT02943941|144352398|OTHER|||||||0.429|||||||ANOVA|||||||0.429
72420406|NCT02943941|144352399|OTHER|||||||0.059||||||Pressure during coughing versus normal breathing initially measured at baseline.|ANOVA|||||||0.059
72420407|NCT02943941|144352400|OTHER||||||<|0.001|||||||ANOVA|||||||<0.001
72420408|NCT02940574|144352417|OTHER|Linear mixed-effect analyses, exploring whether a single-dose of OT could reduce amygdala connectivity, revealed a tentative effect of 'treatment' (F(1,36)=2.00; p=.08 (one-sided))|||||<|0.08||||||Linear mixed-effect analyses, exploring whether a single-dose of OT could reduce amygdala connectivity, revealed a tentative effect of 'treatment' (F(1,36)=2.00; p=.08 (one-sided))|Mixed Models Analysis|(F(1,36)=2.00; p=.08 (one-sided))||||||<0.08
72328196|NCT00809926|144180912|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-0.2||||0.79|TWO_SIDED|95.0|-1.93|1.47|||ANCOVA|||||1.47|-1.93|0.790
72328197|NCT00809926|144180913|SUPERIORITY_OR_OTHER||Difference|8.1||||0.101|TWO_SIDED|95.0|-1.56|17.67|||Cochran-Mantel-Haenszel|||||17.67|-1.56|0.101
72328198|NCT00809926|144180914|SUPERIORITY_OR_OTHER||Difference|11.6||||0.018|TWO_SIDED|95.0|2.0|21.33|||Cochran-Mantel-Haenszel|||||21.33|2.00|0.018
72328199|NCT00809926|144180917|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-3.4||||0.028|TWO_SIDED|95.0|-6.34|-0.37|||ANCOVA|||||-0.37|-6.34|0.028
72328200|NCT00809926|144180918|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-3.1||||0.04|TWO_SIDED|95.0|-6.02|-0.14|||GENMOD|Based on a generalized estimating equations using SAS procedure GENMOD.||||-0.14|-6.02|0.040
72328201|NCT00809926|144180919|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-8.7||||0.004|TWO_SIDED|95.0|-14.38|-2.93|||ANCOVA|||||-2.93|-14.38|0.004
72328202|NCT00809926|144180920|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-4.9||||0.006|TWO_SIDED|95.0|-8.37|-1.42|||ANCOVA|||||-1.42|-8.37|0.006
72328203|NCT00326001|144180949|SUPERIORITY_OR_OTHER|||||||0.25||95.0||||P-value not adjusted for multiple comparisons|t-test, 2 sided|||||||0.25
72328204|NCT00326001|144180950|SUPERIORITY_OR_OTHER|||||||0.042||95.0|||||Chi-squared|||||||0.042
72328205|NCT00326001|144180951|SUPERIORITY_OR_OTHER|||||||0.53||95.0|||||Chi-squared|||||||0.53
72328206|NCT00326001|144180952|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||||||<0.001
72328207|NCT01665911|144180978|SUPERIORITY_OR_OTHER|||||||0.049||||||Non-fluoridated milk, 200 ml vs. 1.5 mg Sodium Fluoride in 100 ml milk|ANOVA|||Based on prior studies using a variety of products in this model, the within-product standard deviation of %SMH recovery is estimated to be 13% and the correlation between products is expected to be approximately 0.5. With a sample size of 28 subjects in a 5-way crossover study, the study will have 80% power to detect a %SMH recovery difference of 8.6%, assuming two-sided tests each conducted at a 5% significance level.||||0.0490
72328208|NCT01665911|144180978|SUPERIORITY_OR_OTHER|||||||0.19||||||Non-fluoridated milk, 200 ml vs. 1.5 mg sodium fluoride in 200 ml milk|ANOVA|||||||0.19
72328209|NCT01665911|144180978|SUPERIORITY_OR_OTHER|||||||0.0017||||||Non-fluoridated milk, 200 ml vs. 3 mg sodium fluoride in 100 ml milk|ANOVA|||||||0.0017
72328210|NCT01665911|144180978|SUPERIORITY_OR_OTHER|||||||0.0092||||||Non-fluoridated milk, 200 ml vs. 3 mg sodium fluoride in 200 ml milk|ANOVA|||||||0.0092
72328211|NCT01665911|144180978|SUPERIORITY_OR_OTHER|||||||0.45||||||1.5 mg Sodium Fluoride in 100 ml milk vs. 1.5 mg sodium fluoride in 200 ml milk|ANOVA|||||||0.45
72328212|NCT01665911|144180978|SUPERIORITY_OR_OTHER|||||||0.18||||||1.5 mg Sodium Fluoride in 100 ml milk vs. 3 mg sodium fluoride in 100 ml milk|ANOVA|||||||0.18
72328213|NCT01665911|144180978|SUPERIORITY_OR_OTHER|||||||0.47||||||1.5 mg Sodium Fluoride in 100 ml milk vs. 3 mg sodium fluoride in 200 ml milk|ANOVA|||||||0.47
72328214|NCT01665911|144180978|SUPERIORITY_OR_OTHER|||||||0.0423||||||1.5 mg sodium fluoride in 200 ml milk vs. 3 mg sodium fluoride in 100 ml milk|ANOVA|||||||0.0423
72328215|NCT01665911|144180978|SUPERIORITY_OR_OTHER|||||||0.15||||||1.5 mg sodium fluoride in 200 ml milk vs. 3 mg sodium fluoride in 200 ml milk|ANOVA|||||||0.15
72328216|NCT01665911|144180978|SUPERIORITY_OR_OTHER|||||||0.54||||||3 mg sodium fluoride in 100 ml milk vs. 3 mg sodium fluoride in 200 ml milk|ANOVA|||||||0.54
72328217|NCT01665911|144180979|SUPERIORITY_OR_OTHER|||||||0.24||||||Non-fluoridated milk, 200 ml vs. 1.5 mg Sodium Fluoride in 100 ml milk|ANOVA|||||||0.24
72328218|NCT01665911|144180979|SUPERIORITY_OR_OTHER|||||||0.17||||||Non-fluoridated milk, 200 ml vs. 1.5 mg sodium fluoride in 200 ml milk|ANOVA|||||||0.17
72328219|NCT01665911|144180979|SUPERIORITY_OR_OTHER|||||||0.0008||||||Non-fluoridated milk, 200 ml vs. 3 mg sodium fluoride in 100 ml milk|ANOVA|||||||0.0008
72328220|NCT01665911|144180979|SUPERIORITY_OR_OTHER|||||||0.0003||||||Non-fluoridated milk, 200 ml vs. 3 mg sodium fluoride in 200 ml milk|ANOVA|||||||0.0003
72328221|NCT01665911|144180979|SUPERIORITY_OR_OTHER|||||||0.24||||||1.5 mg Sodium Fluoride in 100 ml milk vs. 1.5 mg Sodium Fluoride in 200 ml milk|ANOVA|||||||0.24
72328222|NCT01665911|144180979|SUPERIORITY_OR_OTHER|||||||0.26||||||1.5 mg Sodium Fluoride in 100 ml milk vs. 3 mg sodium fluoride in 100 ml milk|ANOVA|||||||0.26
72328223|NCT01665911|144180979|SUPERIORITY_OR_OTHER|||||||0.18||||||1.5 mg Sodium Fluoride in 100 ml milk vs. 3 mg sodium fluoride in 200 ml milk|ANOVA|||||||0.18
72328224|NCT01665911|144180979|SUPERIORITY_OR_OTHER|||||||0.0269||||||1.5 mg sodium fluoride in 200 ml milk vs. 3 mg sodium fluoride in 100 ml milk|ANOVA|||||||0.0269
72328225|NCT01665911|144180979|SUPERIORITY_OR_OTHER|||||||0.0142||||||1.5 mg sodium fluoride in 200 ml milk vs. 3 mg sodium fluoride in 200 ml milk|ANOVA|||||||0.0142
72328226|NCT01665911|144180979|SUPERIORITY_OR_OTHER|||||||0.81||||||3 mg sodium fluoride in 100 ml milk vs. 3 mg sodium fluoride in 200 ml milk|ANOVA|||||||0.81
72328227|NCT01665911|144180980|SUPERIORITY_OR_OTHER|||||||0||||||Non-fluoridated milk, 200 ml vs. 1.5 mg Sodium Fluoride in 100 ml milk|ANOVA|||||||0.0000
72328228|NCT01665911|144180980|SUPERIORITY_OR_OTHER|||||||0||||||Non-fluoridated milk, 200 ml vs. 1.5 mg sodium fluoride in 200 ml milk|ANOVA|||||||0.0000
72328229|NCT01665911|144180980|SUPERIORITY_OR_OTHER|||||||0||||||Non-fluoridated milk, 200 ml vs. 3 mg sodium fluoride in 100 ml milk|ANOVA|||||||0.0000
72328230|NCT01665911|144180980|SUPERIORITY_OR_OTHER|||||||0||||||Non-fluoridated milk, 200 ml vs. 3 mg sodium fluoride in 200 ml milk|ANOVA|||||||0.0000
72328231|NCT01665911|144180980|SUPERIORITY_OR_OTHER|||||||0.14||||||1.5 mg Sodium Fluoride in 100 ml milk vs. 1.5 mg Sodium Fluoride in 200 ml milk|ANOVA|||||||0.14
72328232|NCT01665911|144180980|SUPERIORITY_OR_OTHER|||||||0.0012||||||1.5 mg Sodium Fluoride in 100 ml milk vs. 3 mg sodium fluoride in 100 ml milk|ANOVA|||||||0.0012
72328233|NCT01665911|144180980|SUPERIORITY_OR_OTHER|||||||0.19||||||1.5 mg Sodium Fluoride in 100 ml milk vs. 3 mg sodium fluoride in 200 ml milk|ANOVA|||||||0.19
72328234|NCT01665911|144180980|SUPERIORITY_OR_OTHER|||||||0||||||1.5 mg sodium fluoride in 200 ml milk vs. 3 mg sodium fluoride in 100 ml milk|ANOVA|||||||0.0000
72328235|NCT01665911|144180980|SUPERIORITY_OR_OTHER|||||||0.0075||||||1.5 mg sodium fluoride in 200 ml milk vs. 3 mg sodium fluoride in 200 ml milk|ANOVA|||||||0.0075
72328236|NCT01665911|144180980|SUPERIORITY_OR_OTHER|||||||0.0444||||||3 mg sodium fluoride in 100 ml milk vs. 3 mg sodium fluoride in 200 ml milk|ANOVA|||||||0.0444
72328237|NCT04830215|144180987|OTHER||||||<|0.0001||||||MMRM included fixed effect terms for visit, baseline value, an interaction term of baseline value by visit, and trial center.|MMRM|||||||<0.0001
72328238|NCT04830215|144180988|OTHER||||||<|0.0001||||||MMRM included fixed effect terms for visit, baseline value, an interaction term of baseline value by visit, and trial center.|MMRM|||||||<0.0001
72328239|NCT00703963|144181014|SUPERIORITY_OR_OTHER|||||||0.2|||||||Wilcoxon (Mann-Whitney)|||Statistical significance was defined as p \< 0.05.||||0.20
72328240|NCT00703963|144181015|SUPERIORITY_OR_OTHER|||||||0.05|||||||Wilcoxon (Mann-Whitney)|||Statistical significance was defined as p \< 0.05.||||0.05
72328241|NCT00703963|144181016|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Statistical significance was defined as p \< 0.05.||||<0.001
72328242|NCT00402324|144181019|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||All tests of treatment effects will be conducted at a two-sided alpha level of 0.05 unless otherwise stated.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) Change = Therapy PooledINV Visit Baseline Baseline\*Visit Therapy\*Visit. P-value from therapy term in model.||The overall power of the two co-primary analyses-the probability of simultaneously rejecting both co-primary null hypotheses-for this sample size under assumed effect sizes of 0.5 and 0.45 is estimated as approximately 85-87% and 77-80%, respectively.||||<0.001
72328243|NCT00402324|144181020|SUPERIORITY_OR_OTHER|||||||0.022||95.0||||All tests of treatment effects will be conducted at a two-sided alpha level of 0.05 unless otherwise stated.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) Change = Therapy PooledINV Visit Baseline Baseline\*Visit Therapy\*Visit. P-value from therapy term in model.||The overall power of the two co-primary analyses-the probability of simultaneously rejecting both co-primary null hypotheses-for this sample size under assumed effect sizes of 0.5 and 0.45 is estimated as approximately 85-87% and 77-80%, respectively.||||0.022
72328244|NCT00402324|144181021|SUPERIORITY_OR_OTHER|||||||0.1||95.0|||||Fisher Exact|||||||0.100
72328245|NCT00402324|144181022|SUPERIORITY_OR_OTHER|||||||0.048||95.0|||||Fisher Exact|||||||0.048
72328246|NCT00402324|144181023|SUPERIORITY_OR_OTHER|||||||0.056||95.0|||||ANCOVA|Type III sums of squares of ANCOVA model: Change= TRT + Pooled Investigator + Baseline.||||||0.056
72328247|NCT00402324|144181025|SUPERIORITY_OR_OTHER|||||||0.657||95.0||||P-value for Total Cholesterol Change from Baseline|ANOVA|Type III sums of squares of ANOVA model: Ranked Change= Treatment + Pooled Investigator||||||0.657
72420409|NCT03525548|144352440|SUPERIORITY||Least squares (LS) mean difference|10.0|||<|0.0001|TWO_SIDED|95.0|7.4|12.6|||Mixed-effects model for repeated measure|||||12.6|7.4|<0.0001
72420410|NCT03525548|144352441|SUPERIORITY||LS mean difference|-45.1|||<|0.0001|TWO_SIDED|95.0|-50.1|-40.1|||Mixed-effects model for repeated measure|||||-40.1|-50.1|<0.0001
72420411|NCT03525548|144352442|SUPERIORITY||LS mean difference|17.4|||<|0.0001|TWO_SIDED|95.0|11.8|23.0|||Mixed-effects model for repeated measure|||||23.0|11.8|<0.0001
72420412|NCT02623855|144352452|SUPERIORITY|Our hypothesis was that park prescriptions with group visits would have a superior result than park prescriptions alone.||||||0.6099|||||||t-test, 2 sided|||The study is powered for our primary outcome, caregiver stress as measured by the 10-item perceived stress s score (PSS10). Normative data from population samples show a mean PSS10 score of 13.2 points with a standard deviation of 6.35 points and a within-subject correlation coefficient of 0.77 over 2 weeks.We powered the study to detect a three point difference in the change of the PSS10. This effect size is consistent with other estimates of a clinically significant change.||||0.6099
72420413|NCT02623855|144352454|SUPERIORITY|||||||0.0085|||||||t-test, 2 sided|||||||0.0085
72328248|NCT00402324|144181025|SUPERIORITY_OR_OTHER|||||||0.924||95.0||||P-value for Low Density Lipoprotein Change from Baseline|ANOVA|Type III sums of squares of ANOVA model: Ranked Change= Treatment + Pooled Investigator||||||0.924
72328249|NCT00402324|144181025|SUPERIORITY_OR_OTHER|||||||0.122||95.0||||P-value for High Density Lipoprotein Change from Baseline|ANOVA|Type III sums of squares of ANOVA model: Ranked Change= Treatment + Pooled Investigator||||||0.122
72328250|NCT00402324|144181026|SUPERIORITY_OR_OTHER|||||||0.293||95.0||||P-value for Fasting Triglycerides Change from Baseline|ANOVA|Type III sums of squares of ANOVA model: Ranked Change= Treatment + Pooled Investigator||||||0.293
72328251|NCT00402324|144181027|SUPERIORITY_OR_OTHER|||||||0.007||95.0||||P-value for Fasting Blood Glucose Change from Baseline|ANOVA|Type III sums of squares of ANOVA model: Ranked Change= Treatment + Pooled Investigator||||||0.007
72328252|NCT00402324|144181028|SUPERIORITY_OR_OTHER|||||||0.046||95.0||||P-value for Bilirubin Total Change from Baseline|ANOVA|Type III sums of squares of ANOVA model: Ranked Change= Treatment + Pooled Investigator||||||0.046
72328253|NCT00402324|144181029|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|Type III sums of squares of ANCOVA model: Change= Treatment + Pooled Investigator + Baseline||||||<0.001
72328254|NCT00402324|144181030|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|Type III sums of squares of ANCOVA model: Change= Treatment + Pooled Investigator + Baseline||||||<0.001
72328255|NCT00402324|144181031|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Fisher Exact|||||||<0.001
72328256|NCT03994211|144181032|OTHER||Geometric Mean Ratio Estimate|0.94|||||TWO_SIDED|90.0|0.83|1.06||||||||1.06|0.83|
72328257|NCT03994211|144181033|OTHER||Geometric Mean Ratio|1.05|||||TWO_SIDED|90.0|0.95|1.15||||||||1.15|0.95|
72328258|NCT03994211|144181034|OTHER||Geometric Mean Ratio|0.62|||||TWO_SIDED|90.0|0.54|0.7||||||||0.70|0.54|
72328259|NCT03994211|144181035|OTHER||Geometric Mean Ratio|0.99|||||TWO_SIDED|90.0|0.91|1.09||||||||1.09|0.91|
72328260|NCT03994211|144181036|OTHER||Geometric Mean Ratio|0.57|||||TWO_SIDED|90.0|0.48|0.69||||||||0.69|0.48|
72328261|NCT03994211|144181037|OTHER||Geometric Mean Ratio|0.99|||||TWO_SIDED|90.0|0.9|1.09||||||||1.09|0.90|
72328262|NCT04677543|144181091|SUPERIORITY||Percentage Difference|10.4||||0.2819|TWO_SIDED|95.0|-8.6|29.5|||Standardized Logistic Regression||The percentage difference and confidence intervals are estimated by standardized logistic regression with treatment group and history of MAC lung infection as factors in the model.|||29.5|-8.6|0.2819
72420414|NCT02623855|144352456|SUPERIORITY|||||||0.1749|||||||t-test, 2 sided|||||||0.1749
72420415|NCT02634788|144352460|OTHER||LS Mean Difference|81.93|STANDARD_ERROR_OF_MEAN|14.283|<|0.0001|TWO_SIDED|95.0|53.82|110.04|||ANCOVA|The analysis included treatment and site as main effects and Baseline pain intensity as the covariate.||||110.04|53.82|<0.0001
72420416|NCT02634788|144352460|OTHER||LS Mean Difference|36.18|STANDARD_ERROR_OF_MEAN|14.099||0.0108|TWO_SIDED|95.0|8.43|63.93|||ANCOVA|The analysis included treatment and site as main effects and Baseline pain intensity as the covariate.||||63.93|8.43|0.0108
72420417|NCT02634788|144352460|OTHER||LS Mean Difference|35.46|STANDARD_ERROR_OF_MEAN|14.02||0.012|TWO_SIDED|95.0|7.86|63.05|||ANCOVA|The analysis included treatment and site as main effects and Baseline pain intensity as the covariate.||||63.05|7.86|0.0120
72328263|NCT04677543|144181092|SUPERIORITY||Percentage Difference|6.1||||0.508|TWO_SIDED|95.0|-11.9|24.1|||Standardized Logistic Regression||The percentage difference and confidence intervals are estimated by standardized logistic regression with treatment group and history of MAC lung infection as factors in the model.|||24.1|-11.9|0.5080
72328264|NCT04677543|144181093|SUPERIORITY||Percentage Difference|16.7||||0.0712|TWO_SIDED|95.0|-1.4|34.9|||Standardized Logistic Regression|||||34.9|-1.4|0.0712
72328265|NCT04677543|144181094|SUPERIORITY||Least Square Mean Difference|4.48||||0.1073|TWO_SIDED|95.0|-0.97|9.93|||ANCOVA|||||9.93|-0.97|0.1073
72328266|NCT04677543|144181095|SUPERIORITY||Least Square Mean Difference|-0.4||||0.613|TWO_SIDED|95.0|-2.2|1.3|||ANCOVA|||||1.3|-2.2|0.6130
72328267|NCT04677543|144181096|SUPERIORITY||Hazard Ratio (HR)|1.23||||0.3542|TWO_SIDED|95.0|0.79|1.92|||Regression, Cox||A Cox regression model was applied to calculate the hazard ratio. The model included effects for treatment and history of MAC lung infection (initial or subsequent).|||1.92|0.79|0.3542
72328268|NCT04677543|144181097|SUPERIORITY||Hazard Ratio (HR)|1.35||||0.1583|TWO_SIDED|95.0|0.89|2.06|||Regression, Cox||A Cox regression model was applied to calculate the hazard ratio. The model included effects for treatment and history of MAC lung infection (initial or subsequent).|||2.06|0.89|0.1583
72328269|NCT02110485|144181105|SUPERIORITY|||||||0.03|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||0.03
72328270|NCT02110485|144181106|OTHER|||||||0.27|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||.27
72328271|NCT02110485|144181107|OTHER|||||||0.67|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||.67
72328272|NCT02110485|144181108|OTHER|||||||0.17|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||.17
72328273|NCT02110485|144181109|OTHER|||||||0.84|||||||Fisher Exact|||||||.84
72420418|NCT02496767|144352487|SUPERIORITY||Least squares mean difference|1.707|STANDARD_ERROR_OF_MEAN|1.9365||0.3782|TWO_SIDED|95.0|-2.089|5.503|||Repeated-measures mixed model|||||5.503|-2.089|0.3782
72328274|NCT02110485|144181110|OTHER|||||||0.99|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||.99
72328275|NCT00995436|144181111|NON_INFERIORITY_OR_EQUIVALENCE|The calculation indicated that for a study with the power of 80% and an alpha of 0.05 we required 21 participants per group. Assumed drop out rate 20%, suggesting 75 patients required.|Mean Difference (Final Values)|-0.58|||||TWO_SIDED|95.0|-1.53|0.36|||||Maxillary right molar|||0.36|-1.53|
72328276|NCT00995436|144181111|NON_INFERIORITY_OR_EQUIVALENCE|The calculation indicated that for a study with the power of 80% and an alpha of 0.05 we required 21 participants per group. Assumed drop out rate 20%, suggesting 75 patients required.|Mean Difference (Final Values)|-0.96|||||TWO_SIDED|95.0|-1.89|-0.04|||||Maxillary left molar|||-0.04|-1.89|
72328277|NCT00995436|144181111|NON_INFERIORITY_OR_EQUIVALENCE|The calculation indicated that for a study with the power of 80% and an alpha of 0.05 we required 21 participants per group. Assumed drop out rate 20%, suggesting 75 patients required.|Mean Difference (Final Values)|0.62|||||TWO_SIDED|95.0|-0.32|1.55|||||Maxillary right molar|||1.55|-0.32|
72420419|NCT02496767|144352487|SUPERIORITY||Least squares mean difference|0.612|STANDARD_ERROR_OF_MEAN|2.0245||0.7625|TWO_SIDED|95.0|-3.359|4.583|||Repeated-measures mixed model|||||4.583|-3.359|0.7625
72328278|NCT00995436|144181111|NON_INFERIORITY_OR_EQUIVALENCE|The calculation indicated that for a study with the power of 80% and an alpha of 0.05 we required 21 participants per group. Assumed drop out rate 20%, suggesting 75 patients required.|Mean Difference (Final Values)|-0.09|||||TWO_SIDED|95.0|-1.0|0.83|||||Maxillary left molar|||0.83|-1|
72420420|NCT02496767|144352487|SUPERIORITY||Least squares mean difference|0.428|STANDARD_ERROR_OF_MEAN|2.1081||0.8394|TWO_SIDED|95.0|-3.711|4.566|||Repeated-measures mixed model|||||4.566|-3.711|0.8394
72328279|NCT00995436|144181111|NON_INFERIORITY_OR_EQUIVALENCE|The calculation indicated that for a study with the power of 80% and an alpha of 0.05 we required 21 participants per group. Assumed drop out rate 20%, suggesting 75 patients required.||||||0.05||||||Maxillary right molar. F(2, 67) = 3.10. Overall effect of treatment.|ANCOVA|||||||0.05
72420421|NCT02496767|144352488|SUPERIORITY||Least squares mean difference|0.31|STANDARD_ERROR_OF_MEAN|0.41||0.4521|TWO_SIDED|95.0|-0.5|1.12|||Repeated-measures mixed model|||||1.12|-0.50|0.4521
72420422|NCT02496767|144352488|SUPERIORITY||Least squares mean difference|-0.16|STANDARD_ERROR_OF_MEAN|0.426||0.712|TWO_SIDED|95.0|-1.0|0.68|||Repeated-measures mixed model|||||0.68|-1.00|0.7120
72420423|NCT02496767|144352488|SUPERIORITY||Least squares mean difference|-0.33|STANDARD_ERROR_OF_MEAN|0.439||0.451|TWO_SIDED|95.0|-1.19|0.53|||Repeated-measures mixed model|||||0.53|-1.19|0.4510
72328280|NCT00995436|144181111|NON_INFERIORITY_OR_EQUIVALENCE|The calculation indicated that for a study with the power of 80% and an alpha of 0.05 we required 21 participants per group. Assumed drop out rate 20%, suggesting 75 patients required.||||||0.08||||||Overall effect of treatment F(2,67) = 2.58.|ANCOVA|||Maxillary left molar.||||0.08
72328281|NCT03711370|144181118|OTHER|Repeated measures ANOVA was used to model between-subject effects of group (Clear versus Opaque), within-subjects effects of use of clear versus opaque bottles during the feeding observations, and potential group by bottle type interactions on infant intake during post-test feeding observations.||||||0.76||||||Statistical significance was defined as p \< 0.05.|Mixed Models Analysis|Models controlled for pre-test values, infant sex and age, time since last feeding, and whether the assessment was in-person or remote.||||||0.76
72328282|NCT03711370|144181119|OTHER|Repeated measures ANOVA was used to model between-subject effects of group (Clear versus Opaque), within-subjects effects of use of clear versus opaque bottles during the feeding observations, and potential group by-bottle type interactions on maternal sensitivity during post-test feeding observations.||||||0.64||||||Statistical significance was defined as p \< 0.05.|Mixed Models Analysis|Models controlled for pre-test values, infant sex and age, time since last feeding, and whether the assessment was in-person or remote.||||||0.64
72328283|NCT03711370|144181120|OTHER|General linear models were used to compare post-test weight-for-length z-scores (WLZ).||||||0.02||||||Statistical significance was defined as p \< 0.05.|Regression, Linear|These models controlled for baseline values (i.e., baseline WLZ), infant sex and age, and whether the assessment was in-person or remote.||||||0.02
72328284|NCT03711370|144181121|OTHER|General linear models were used to compare post-test waist circumference for the Clear versus Opaque groups.||||||0.07||||||Statistical significance was defined as p \< 0.05.|Regression, Linear|Model controlled for baseline values (i.e., waist circumference), infant sex and age, and whether the assessment was in-person or remote.||||||0.07
72328285|NCT03711370|144181122|OTHER|General linear models were used to compare post-test triceps skinfold z-scores for the Clear versus Opaque groups.||||||0.7||||||Statistical significance was defined as p \< 0.05.|Regression, Linear|Model controlled for baseline values (i.e.,triceps skinfolds z-scores), infant sex and age, and whether the assessment was in-person or remote.||||||0.70
72328286|NCT02063984|144181133|SUPERIORITY||Odds Ratio (OR)|0.42|||||TWO_SIDED|95.0|0.11|1.56|||||Outcome was tested in a zero-inflated negative binomial (ZINB) model|CM+No WMT is the comparison condition||1.56|.11|
72328287|NCT02063984|144181134|SUPERIORITY||Ratio of means|1.56|||||TWO_SIDED|95.0|0.79|3.07|||||Outcome was tested in a zero-inflated negative binomial (ZINB) model|CM+No WMT is the comparison condition||3.07|.79|
72328288|NCT02063984|144181135|SUPERIORITY||Odds Ratio (OR)|0.93|||||TWO_SIDED|95.0|0.18|4.82||||||CM+No WMT is the comparison condition||4.82|.18|
72328289|NCT02063984|144181136|SUPERIORITY||Ratio of means|0.92|||||TWO_SIDED|95.0|0.33|2.54|||||Outcome was tested in a zero-inflated negative binomial (ZINB) model|CM+No WMT is the comparison condition||2.54|.33|
72328290|NCT02063984|144181137|SUPERIORITY||Odds Ratio (OR)|1.04|||||TWO_SIDED|95.0|0.45|2.45||||||Strategy 1 is the comparison condition||2.45|.45|
72328291|NCT02063984|144181137|SUPERIORITY||Odds Ratio (OR)|2.29|||||TWO_SIDED|95.0|0.84|6.2||||||Strategy 1 is the comparison condition||6.20|.84|
72328292|NCT02063984|144181137|SUPERIORITY||Odds Ratio (OR)|0.51|||||TWO_SIDED|95.0|0.23|1.13||||||Strategy 1 is the comparison condition||1.13|.23|
72328293|NCT02063984|144181138|SUPERIORITY||Ratio of means|1.21|||||TWO_SIDED|95.0|0.76|1.92||||||Strategy 1 is the comparison condition||1.92|.76|
72328294|NCT02063984|144181138|SUPERIORITY||Ratio of means|0.76|||||TWO_SIDED|95.0|0.49|1.18||||||Strategy 1 is the comparison condition||1.18|.49|
72328295|NCT02063984|144181138|SUPERIORITY||Ratio of means|1.33|||||TWO_SIDED|95.0|0.83|2.15||||||Strategy 1 is the comparison condition||2.15|.83|
72328296|NCT03674970|144181139|OTHER|||||||0.55|||||||ANOVA|||||||.55
72328297|NCT03674970|144181140|OTHER|||||||0.2146|||||||ANOVA|||||||.2146
72328298|NCT03674970|144181141|OTHER|||||||0.5642|||||||ANOVA|||||||.5642
72328299|NCT03674970|144181142|OTHER|||||||0.4353|||||||ANOVA|||||||.4353
72328300|NCT03674970|144181143|OTHER|||||||0.0348|||||||ANOVA|||||||.0348
72328301|NCT03674970|144181144|OTHER|||||||0.404|||||||ANOVA|||||||.4040
72328302|NCT01158820|144181145|OTHER|No data available for power analysis|Mean Difference (Net)|0.028|||<|0.0001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
72328303|NCT01158820|144181146|SUPERIORITY||Mean Difference (Final Values)|43.75|||<|0.01|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||units are µg|See reference power analysis||||<0.01
72328304|NCT01158820|144181147|SUPERIORITY||Median Difference (Final Values)|1.75||||0.01|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||units are mg|See reference for power analysis||||0.01
72328305|NCT03299244|144181156|NON_INFERIORITY|Etelcalcetide was considered non-inferior if the upper bound of the two-sided 95% confidence interval of the treatment difference (Cinacalcet - Etelcalcetide) was smaller than 12%, or if the lower bound of (Etelcalcetide - Cinacalcet) greater than -12%. If this criterion was met, the 2 key secondary endpoints were tested sequentially. If both key secondary endpoints were statistically significant, the other secondary endpoints were to be formally tested at an overall significance level of 0.05.|Treatment Difference|4.52|||||TWO_SIDED|95.0|-3.05|12.09|||||Treatment difference (Etelcalcetide - Cinacalcet) stratified by screening iPTH level, screening cCa level, and country/region.|"The analysis was conducted on the full analysis set (637 participants). Imputation under the non-inferiority null method was applied to participants who did not have PTH data during the EAP.~The Mantel-Haenszel estimator was used to calculate the treatment (Cinacalcet - Etelcalcetide), stratified by screening PTH level (\< 900 pg/mL, ≥ 900 pg/mL), screening serum cCa (\< 9.0 mg/dL, ≥ 9.0 mg/dL) measured by the central laboratory, and country (China versus non-China)."||12.09|-3.05|
72328306|NCT03299244|144181157|SUPERIORITY|Testing of this key secondary efficacy endpoint at an overall significance level of 0.05 was to be performed if non-inferiority was demonstrated for the primary endpoint.|Odds Ratio (OR)|2.02|||<|0.001|TWO_SIDED|95.0|1.47|2.77|||Cochran-Mantel-Haenszel|CMH test stratified by screening iPTH level, screening cCa level, and country/region.|Odds ratio (Etelcalcetide : Cinacalcet) stratified by screening iPTH level, screening cCa level, and country/region.|||2.77|1.47|<0.001
72420424|NCT02496767|144352489|SUPERIORITY||Mean Difference (Final Values)|-0.0011||||0.9505|TWO_SIDED|95.0|-0.0374|0.0351|||Repeated-measures mixed model|||||0.0351|-0.0374|0.9505
72420425|NCT02496767|144352489|SUPERIORITY||Mean Difference (Final Values)|0.0066||||0.7336|TWO_SIDED|95.0|-0.0317|0.045|||Repeated-measures mixed model|||||0.0450|-0.0317|0.7336
72420426|NCT02496767|144352489|SUPERIORITY||Mean Difference (Final Values)|0.0088||||0.6593|TWO_SIDED|95.0|-0.0303|0.0479|||Repeated-measures mixed model|||||0.0479|-0.0303|0.6593
72420427|NCT02496767|144352490|SUPERIORITY||Hazard Ratio (HR)|0.818||||0.2369|TWO_SIDED|95.0|0.587|1.141|||Regression, Cox||Hazard ratio for tirasemtiv vs placebo|||1.141|0.587|0.2369
72420428|NCT02496767|144352490|SUPERIORITY||Hazard Ratio (HR)|0.988||||0.942|TWO_SIDED|95.0|0.711|1.372|||Regression, Cox||Hazard ratio for tirasemtiv vs placebo|||1.372|0.711|0.9420
72420429|NCT02496767|144352490|SUPERIORITY||Hazard Ratio (HR)|0.933||||0.6853|TWO_SIDED|95.0|0.668|1.304|||Regression, Cox||Hazard ratio for tirasemtiv vs placebo|||1.304|0.668|0.6853
72420430|NCT02496767|144352491|SUPERIORITY||Hazard Ratio (HR)|1.066||||0.7667|TWO_SIDED|95.0|0.698|1.627|||Regression, Cox||Hazard ratio for tirasemtiv vs placebo|||1.627|0.698|0.7667
72420431|NCT02496767|144352491|SUPERIORITY||Hazard Ratio (HR)|0.904||||0.6619|TWO_SIDED|95.0|0.577|1.419|||Regression, Cox||Hazard ratio for tirasemtiv vs placebo|||1.419|0.577|0.6619
72420432|NCT02496767|144352491|SUPERIORITY||Hazard Ratio (HR)|0.882||||0.5856|TWO_SIDED|95.0|0.561|1.386|||Regression, Cox||Hazard ratio for tirasemtiv vs placebo|||1.386|0.561|0.5856
72420433|NCT02496767|144352492|SUPERIORITY||Least squares mean difference|0.0|STANDARD_ERROR_OF_MEAN|1.103||0.9991|TWO_SIDED|95.0|-2.17|2.17|||Repeated-measures mixed model|||||2.17|-2.17|0.9991
72420434|NCT02496767|144352492|SUPERIORITY||Least squares mean difference|-0.8|STANDARD_ERROR_OF_MEAN|1.138||0.4808|TWO_SIDED|95.0|-3.04|1.43|||Repeated-measures mixed model|||||1.43|-3.04|0.4808
72420435|NCT02496767|144352492|SUPERIORITY||Least squares mean difference|-0.6|STANDARD_ERROR_OF_MEAN|1.165||0.6082|TWO_SIDED|95.0|-2.89|1.69|||Repeated-measures mixed model|||||1.69|-2.89|0.6082
72420436|NCT02496767|144352493|SUPERIORITY||Hazard Ratio (HR)|0.776||||0.2602|TWO_SIDED|95.0|0.5|1.206|||Regression, Cox||Hazard ratio for tirasemtiv vs placebo|||1.206|0.500|0.2602
72420437|NCT02496767|144352493|SUPERIORITY||Hazard Ratio (HR)|1.094||||0.6748|TWO_SIDED|95.0|0.72|1.662|||Regression, Cox||Hazard ratio for tirasemtiv vs placebo|||1.662|0.720|0.6748
72420438|NCT02496767|144352493|SUPERIORITY||Hazard Ratio (HR)|0.938||||0.7694|TWO_SIDED|95.0|0.609|1.443|||Regression, Cox||Hazard ratio for tirasemtiv vs placebo|||1.443|0.609|0.7694
72420439|NCT02277990|144352494|SUPERIORITY||Hazard Ratio (HR)|0.6||||0.0406|TWO_SIDED|95.12|0.36|0.98||The 0.05 critical value for assessing the primary endpoint was adjusted to 0.0488, to account for a planned interim analysis.|Regression, Cox|The Cox regression was stratified according to device type (pacemaker or CRT-P vs. ICD or CRT-D).||||0.98|0.36|0.0406
72420440|NCT02277990|144352495|SUPERIORITY||Hazard Ratio (HR)|0.67||||0.0248|TWO_SIDED|95.12|0.47|0.96|||Regression, Cox|||||0.96|0.47|0.0248
72420441|NCT02277990|144352496|NON_INFERIORITY|The non-inferiority test was performed on the as-treated cohort, per the statistical analysis plan. The non-inferiority margin for the hazard ratio was 1.33 (i.e., the hazard ratio for complications in the envelope group vs. the control group must be significantly lower than 1.33).|Hazard Ratio (HR)|0.93|||<|0.01|TWO_SIDED|95.12|0.77|1.12|||Regression, Cox|||||1.12|0.77|<0.01
72420442|NCT02277990|144352497|SUPERIORITY||Hazard Ratio (HR)|0.63||||0.0402|TWO_SIDED|95.12|0.4|0.98|||Regression, Cox|||||0.98|0.40|0.0402
72420443|NCT04711603|144352498|SUPERIORITY||Placebo difference|-0.97|STANDARD_ERROR_OF_MEAN|0.28|<|0.001|TWO_SIDED|95.0|-1.52|-0.42|||MMRM|||||-0.42|-1.52|<0.001
72420444|NCT04270747|144352530|OTHER|A pre-specified similarity margin of (-3, 3) ETDRS letters was used to demonstrate clinical similarity for the mean change from Baseline in BCVA at Week 8.|Difference between means|0.1|||||TWO_SIDED|90.0|-1.1|1.3|||||Estimated using analysis of covariance (ANCOVA) model adjusted for the stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA as covariates.|Difference in mean change from Baseline at Week 8.||1.3|-1.1|
72420445|NCT04270747|144352531|OTHER||Risk Difference (RD)|-2.1|||||TWO_SIDED|90.0|-5.2|2.2|||||Estimated using the stratified Newcombe confidence limits (with Mantel-Haenszel weights) adjusting for stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA (BCVA \< 64 letters, BCVA ≥ 64 letters).|Risk difference in percentage of participants who maintained vision at Week 52.||2.2|-5.2|
72420446|NCT04270747|144352531|OTHER||Risk Difference (RD)|-1.7|||||TWO_SIDED|90.0|-6.2|2.8|||||Estimated using the stratified Newcombe confidence limits (with Mantel-Haenszel weights) adjusting for stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA (BCVA \< 64 letters, BCVA ≥ 64 letters).|Risk difference in percentage of participants who maintained vision at Week 52.||2.8|-6.2|
72420447|NCT04270747|144352532|OTHER||Difference between means|-0.1|||||TWO_SIDED|90.0|-1.3|1.2|||||Estimated using ANCOVA model adjusted for the stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA as covariates.|Difference in mean change from Baseline at Week 4.||1.2|-1.3|
72328307|NCT03299244|144181158|SUPERIORITY|Testing of this key secondary efficacy endpoint at an overall significance level of 0.05 was to be performed if non-inferiority was demonstrated for the primary endpoint, and superiority was demonstrated for the previous key secondary endpoint.|Odds Ratio (OR)|1.42||||0.033|TWO_SIDED|95.0|1.03|1.96|||Cochran-Mantel-Haenszel|CMH test stratified by screening iPTH level, screening cCa level, and country/region.|Odds ratio (Etelcalcetide : Cinacalcet) stratified by screening iPTH level, screening cCa level, and country/region.|||1.96|1.03|0.033
72420448|NCT04270747|144352532|OTHER||Difference between means|-0.8|||||TWO_SIDED|90.0|-2.3|0.7|||||Estimated using ANCOVA model adjusted for the stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA as covariates.|Difference in mean change from Baseline at Week 8.||0.7|-2.3|
72420449|NCT04270747|144352532|OTHER||Difference between means|-0.3|||||TWO_SIDED|90.0|-1.9|1.2|||||Estimated using ANCOVA model adjusted for the stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA as covariates.|Difference in mean change from Baseline at Week 16.||1.2|-1.9|
72420450|NCT04270747|144352532|OTHER||Difference between means|0.4|||||TWO_SIDED|90.0|-1.3|2.1|||||Estimated using ANCOVA model adjusted for the stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA as covariates.|Difference in mean change from Baseline at Week 24.||2.1|-1.3|
72328308|NCT03299244|144181159|SUPERIORITY||Difference in Least Squares Means|-2.82|STANDARD_ERROR_OF_MEAN|0.67|<|0.001|TWO_SIDED|95.0|-4.14|-1.5|||Mixed-effects Model Repeated Measures|Model includes treatment group, randomization stratification factors, study week, and study week by treatment as covariates.|Treatment difference (Etelcalcetide - Cinacalcet) stratified by screening iPTH level, screening cCa level, and country/region. Standard error of the mean is the standard error of the least squares means difference.|||-1.50|-4.14|<0.001
72328309|NCT03299244|144181160|SUPERIORITY||Odds Ratio (OR)|1.16||||0.41|TWO_SIDED|95.0|0.82|1.65|||Cochran-Mantel-Haenszel|CMH test stratified by screening iPTH level, screening cCa level, and country/region.|Odds ratio (Etelcalcetide : Cinacalcet) stratified by screening iPTH level, screening cCa level, and country/region.|||1.65|0.82|0.41
72328310|NCT01763333|144181181|SUPERIORITY_OR_OTHER||Slope|0.8728|||||TWO_SIDED|95.0|0.6942|1.0513|||||Dose proportionality was explored using the power model (ANCOVA). The perfect dose proportionality would correspond to a slope β of 1. PK endpoints on the log-transformed scale.|This was non confirmatory testing (Single dose). Dose proportionality of tablets for Cmax was analysed. The per protocol set for the evaluation of dose proportionality (PPS-DP) was used. This set included all subjects of the TS-SRD who provided at least one observation for at least one of the endpoints Cmax, AUC0-tz, AUC0-∞, or Aet1-t2, without experiencing emesis at or before 2 times median tmax and without important PVs relevant to the statistical evaluation of PK.||1.0513|0.6942|
72328311|NCT01763333|144181181|SUPERIORITY_OR_OTHER||Slope|0.9341|||||TWO_SIDED|95.0|0.8277|1.0405|||||Dose proportionality was explored using the power model (ANCOVA). The perfect dose proportionality would correspond to a slope β of 1. PK endpoints on the log-transformed scale.|This was non confirmatory testing (Single dose). Dose proportionality of solution for Cmax was analysed. The per protocol set for the evaluation of dose proportionality (PPS-DP) was used. This set included all subjects of the TS-SRD who provided at least one observation for at least one of the endpoints Cmax, AUC0-tz, AUC0-∞, or Aet1-t2, without experiencing emesis at or before 2 times median tmax and without important PVs relevant to the statistical evaluation of PK.||1.0405|0.8277|
72328312|NCT01763333|144181181|NON_INFERIORITY_OR_EQUIVALENCE|The pharmacokinetic parameters were log transformed (natural logarithm) prior to fitting the ANOVA model. The difference between the expected means of the 2 treatments of interest for each pairwise comparison were estimated by the difference in the corresponding Least Square Means (point estimate) and two-sided 90% confidence intervals based on the t-distribution were computed. These quantities were then back-transformed to the original scale to give the point estimator (geometric mean).|gMean ratio|112.74|||||TWO_SIDED|90.0|95.579|132.993|||||Adjusted gMean ratio.|Relative bioavailability comparison Tab. fed (T1): Tab. fasted (R1) for Cmax. The per protocol set for the evaluation of relative bioavailability of T1 vs R1 (PPS-BA-T1-R1) was used.||132.993|95.579|
72328313|NCT01763333|144181181|NON_INFERIORITY_OR_EQUIVALENCE|The pharmacokinetic parameters were log transformed (natural logarithm) prior to fitting the ANOVA model. The difference between the expected means of the 2 treatments of interest for each pairwise comparison were estimated by the difference in the corresponding Least Square Means (point estimate) and two-sided 90% confidence intervals based on the t-distribution were computed. These quantities were then back-transformed to the original scale to give the point estimator (geometric mean).|gMean ratio|52.66|||||TWO_SIDED|90.0|40.488|68.499|||||Adjusted gMean ratio.|Relative bioavailability comparison Sol. fed (T2) : Sol. fasted (R2) for Cmax. The per protocol set for the evaluation of relative bioavailability of T2 vs R2 (PPS-BA-T2-R2) was used.||68.499|40.488|
72328314|NCT01763333|144181181|NON_INFERIORITY_OR_EQUIVALENCE|The pharmacokinetic parameters were log transformed (natural logarithm) prior to fitting the ANOVA model. The difference between the expected means of the 2 treatments of interest for each pairwise comparison were estimated by the difference in the corresponding Least Square Means (point estimate) and two-sided 90% confidence intervals based on the t-distribution were computed. These quantities were then back-transformed to the original scale to give the point estimator (geometric mean).|gMean ratio|239.63|||||TWO_SIDED|90.0|197.445|290.83|||||Adjusted gMean ratio.|Relative bioavailability comparison Sol. fasted (R2): Tab. fasted (R1) for Cmax. The per protocol set for the evaluation of relative bioavailability of R2 vs R1 (PPS-BA-R2-R1) was used.||290.830|197.445|
72328315|NCT01763333|144181181|NON_INFERIORITY_OR_EQUIVALENCE|The pharmacokinetic parameters were log transformed (natural logarithm) prior to fitting the ANOVA model. The difference between the expected means of the 2 treatments of interest for each pairwise comparison were estimated by the difference in the corresponding Least Square Means (point estimate) and two-sided 90% confidence intervals based on the t-distribution were computed. These quantities were then back-transformed to the original scale to give the point estimator (geometric mean).|gMean ratio|105.47|||||TWO_SIDED|90.0|85.427|130.208|||||Adjusted gMean ratio.|Relative bioavailability comparison Sol. fed (T2): Tab. fed (T1) for Cmax. The per protocol set for the evaluation of relative bioavailability of T2 vs T1 (PPS-BA-T2-T1) was used.||130.208|85.427|
72328316|NCT01763333|144181183|SUPERIORITY_OR_OTHER||Slope|0.8341|||||TWO_SIDED|95.0|0.6485|1.0198|||||Dose proportionality was explored using the power model (ANCOVA). The perfect dose proportionality would correspond to a slope β of 1. PK endpoints on the log-transformed scale.|This was non confirmatory testing (Single dose).Dose proportionality of tablets for AUC0-inf was analysed.The per protocol set for the evaluation of dose proportionality (PPS-DP) was used. This set included all subjects of the TS-SRD who provided at least one observation for at least one of the endpoints Cmax, AUC0-tz, AUC0-∞, or Aet1-t2, without experiencing emesis at or before 2 times median tmax and without important PVs relevant to the statistical evaluation of PK.||1.0198|0.6485|
72328317|NCT01763333|144181183|SUPERIORITY_OR_OTHER||Slope|0.9149|||||TWO_SIDED|95.0|0.8059|1.0239|||||Dose proportionality was explored using the power model (ANCOVA). The perfect dose proportionality would correspond to a slope β of 1. PK endpoints on the log-transformed scale.|This was non confirmatory testing (Single dose).Dose proportionality of solution for AUC0-inf was analysed. The per protocol set for the evaluation of dose proportionality (PPS-DP) was used. This set included all subjects of the TS-SRD who provided at least one observation for at least one of the endpoints Cmax, AUC0-tz, AUC0-∞, or Aet1-t2, without experiencing emesis at or before 2 times median tmax and without important PVs relevant to the statistical evaluation of PK.||1.0239|0.8059|
72420451|NCT04270747|144352532|OTHER||Difference between means|-1.3|||||TWO_SIDED|90.0|-3.1|0.5|||||Estimated using ANCOVA model adjusted for the stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA as covariates.|Difference in mean change from Baseline at Week 32.||0.5|-3.1|
72328318|NCT01763333|144181183|NON_INFERIORITY_OR_EQUIVALENCE|The pharmacokinetic parameters were log transformed (natural logarithm) prior to fitting the ANOVA model. The difference between the expected means of the 2 treatments of interest for each pairwise comparison were estimated by the difference in the corresponding Least Square Means (point estimate) and two-sided 90% confidence intervals based on the t-distribution were computed. These quantities were then back-transformed to the original scale to give the point estimator (geometric mean).|gMean Ratio|86.61|||||TWO_SIDED|90.0|76.529|98.029|||||Adjusted gMean ratio.|Relative bioavailability comparison Tab. fed (T1): Tab. fasted (R1) for AUC0-inf. The per protocol set for the evaluation of relative bioavailability of T1 vs R1 (PPS-BA-T1-R1) was used.||98.029|76.529|
72328319|NCT01763333|144181183|NON_INFERIORITY_OR_EQUIVALENCE|The pharmacokinetic parameters were log transformed (natural logarithm) prior to fitting the ANOVA model. The difference between the expected means of the 2 treatments of interest for each pairwise comparison were estimated by the difference in the corresponding Least Square Means (point estimate) and two-sided 90% confidence intervals based on the t-distribution were computed. These quantities were then back-transformed to the original scale to give the point estimator (geometric mean).|gMean ratio|74.44|||||TWO_SIDED|90.0|66.322|83.562|||||Adjusted gMean ratio.|Relative bioavailability comparison Sol. fed (T2) : Sol. fasted (R2) for AUC0-inf.The per protocol set for the evaluation of relative bioavailability of T2 vs R2 (PPS-BA-T2-R2) was used.||83.562|66.322|
72328320|NCT01763333|144181183|NON_INFERIORITY_OR_EQUIVALENCE|The pharmacokinetic parameters were log transformed (natural logarithm) prior to fitting the ANOVA model. The difference between the expected means of the 2 treatments of interest for each pairwise comparison were estimated by the difference in the corresponding Least Square Means (point estimate) and two-sided 90% confidence intervals based on the t-distribution were computed. These quantities were then back-transformed to the original scale to give the point estimator (geometric mean).|gMean ratio|137.25|||||TWO_SIDED|90.0|119.708|157.353|||||Adjusted gMean ratio.|Relative bioavailability comparison Sol. fasted (R2): Tab. fasted (R1) for AUC0-inf.The per protocol set for the evaluation of relative bioavailability of R2 vs R1 (PPS-BA-R2-R1) was used.||157.353|119.708|
72328321|NCT01763333|144181183|NON_INFERIORITY_OR_EQUIVALENCE|The pharmacokinetic parameters were log transformed (natural logarithm) prior to fitting the ANOVA model. The difference between the expected means of the 2 treatments of interest for each pairwise comparison were estimated by the difference in the corresponding Least Square Means (point estimate) and two-sided 90% confidence intervals based on the t-distribution were computed. These quantities were then back-transformed to the original scale to give the point estimator (geometric mean).|gMean ratio|116.48|||||TWO_SIDED|90.0|111.462|121.724|||||Adjusted gMean ratio.|Relative bioavailability comparison Sol. fed (T2): Tab. fed (T1) for AUC0-inf.The per protocol set for the evaluation of relative bioavailability of T2 vs T1 (PPS-BA-T2-T1) was used.||121.724|111.462|
72328322|NCT01763333|144181184|SUPERIORITY_OR_OTHER||Slope|0.8428|||||TWO_SIDED|95.0|0.658|1.0275|||||Dose proportionality was explored using the power model (ANCOVA). The perfect dose proportionality would correspond to a slope β of 1. PK endpoints on the log-transformed scale.|This was non confirmatory testing (Single dose). Dose proportionality of tablets for AUC 0- tz was analysed. The per protocol set for the evaluation of dose proportionality (PPS-DP) was used. This set included all subjects of the TS-SRD who provided at least one observation for at least one of the endpoints Cmax, AUC0-tz, AUC0-∞, or Aet1-t2, without experiencing emesis at or before 2 times median tmax and without important PVs relevant to the statistical evaluation of PK.||1.0275|0.6580|
72328323|NCT01763333|144181184|SUPERIORITY_OR_OTHER||Slope|0.9307|||||TWO_SIDED|95.0|0.8187|1.0426|||||Dose proportionality was explored using the power model (ANCOVA). The perfect dose proportionality would correspond to a slope β of 1.|This was non confirmatory testing (Single dose). Dose proportionality of solution for AUC0-tz was analysed. The per protocol set for the evaluation of dose proportionality (PPS-DP) was used. This set included all subjects of the TS-SRD who provided at least one observation for at least one of the endpoints Cmax, AUC0-tz, AUC0-∞, or Aet1-t2, without experiencing emesis at or before 2 times median tmax and without important PVs relevant to the statistical evaluation of PK.||1.0426|0.8187|
72420452|NCT04270747|144352532|OTHER||Difference between means|-0.5|||||TWO_SIDED|90.0|-2.3|1.4|||||Estimated using ANCOVA model adjusted for the stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA as covariates.|Difference in mean change from Baseline at Week 40.||1.4|-2.3|
72328324|NCT01763333|144181184|NON_INFERIORITY_OR_EQUIVALENCE|The pharmacokinetic parameters were log transformed (natural logarithm) prior to fitting the ANOVA model. The difference between the expected means of the 2 treatments of interest for each pairwise comparison were estimated by the difference in the corresponding Least Square Means (point estimate) and two-sided 90% confidence intervals based on the t-distribution were computed. These quantities were then back-transformed to the original scale to give the point estimator (geometric mean)|gMean Ratio|86.16|||||TWO_SIDED|90.0|75.735|98.027|||||Adjusted geometric mean (gMean) ratio.|Relative bioavailability comparison Tab. fed (T1) : Tab. fasted (R1) for AUC 0-tz. The per protocol set for the evaluation of relative bioavailability of T1 vs R1 (PPS-BA-T1-R1) was used.||98.027|75.735|
72328325|NCT01763333|144181184|NON_INFERIORITY_OR_EQUIVALENCE|The pharmacokinetic parameters were log transformed (natural logarithm) prior to fitting the ANOVA model. The difference between the expected means of the 2 treatments of interest for each pairwise comparison were estimated by the difference in the corresponding Least Square Means (point estimate) and two-sided 90% confidence intervals based on the t-distribution were computed. These quantities were then back-transformed to the original scale to give the point estimator (geometric mean)|gMean ratio|74.42|||||TWO_SIDED|90.0|65.979|83.941|||||Adjusted gMean ratio.|Relative bioavailability comparison Sol. fed (T2) : Sol. fasted (R2) for AUC 0-tz.The per protocol set for the evaluation of relative bioavailability of T2 vs R2 (PPS-BA-T2-R2) was used.||83.941|65.979|
72328326|NCT01763333|144181184|NON_INFERIORITY_OR_EQUIVALENCE|The pharmacokinetic parameters were log transformed (natural logarithm) prior to fitting the ANOVA model. The difference between the expected means of the 2 treatments of interest for each pairwise comparison were estimated by the difference in the corresponding Least Square Means (point estimate) and two-sided 90% confidence intervals based on the t-distribution were computed. These quantities were then back-transformed to the original scale to give the point estimator (geometric mean).|gMean ratio|137.2|||||TWO_SIDED|90.0|119.611|157.374|||||Adjusted gMean ratio.|Relative bioavailability comparison Sol. fasted (R2): Tab. fasted (R1) for AUC 0-tz.The per protocol set for the evaluation of relative bioavailability of R2 vs R1(PPS-BA-R2-R1) was used.||157.374|119.611|
72328327|NCT01763333|144181184|NON_INFERIORITY_OR_EQUIVALENCE|The pharmacokinetic parameters were log transformed (natural logarithm) prior to fitting the ANOVA model. The difference between the expected means of the 2 treatments of interest for each pairwise comparison were estimated by the difference in the corresponding Least Square Means (point estimate) and two-sided 90% confidence intervals based on the t-distribution were computed. These quantities were then back-transformed to the original scale to give the point estimator (geometric mean).|gMean ratio|116.83|||||TWO_SIDED|90.0|111.814|122.079|||||Adjusted gMean ratio.|Relative bioavailability comparison Sol. fed (T2): Tab. fed (T1) for AUC 0-tz.The per protocol set for the evaluation of relative bioavailability of T2 vs T1 (PPS-BA-T2-T1) was used.||122.079|111.814|
72328328|NCT02227810|144181222|OTHER|||||||0.652|||||||t-test, 2 sided|||||||0.652
72328329|NCT02227810|144181222|SUPERIORITY|||||||0.123|||||||t-test, 2 sided|||||||0.123
72328330|NCT02227810|144181223|SUPERIORITY|||||||0.051|||||||t-test, 2 sided|||||||0.051
72328331|NCT02227810|144181223|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
72328332|NCT02227810|144181224|SUPERIORITY_OR_OTHER|||||||0.051|||||||t-test, 2 sided|||||||0.051
72328333|NCT02227810|144181225|SUPERIORITY_OR_OTHER|||||||0.792|||||||t-test, 2 sided|||||||0.792
72328334|NCT03063606|144181233|SUPERIORITY|Analyses used all available data. Analyses to compare treatments were all intent-to-treat.||||||0.0002|||||||Mixed Models Analysis|Analyses were performed for all randomized patients who attended the first treatment session.||||||.0002
72328335|NCT03063606|144181234|SUPERIORITY|||||||0.83||||||Analyses used all available data. Analyses to compare treatments were all intent-to-treat.|Mixed Models Analysis|Analyses were performed for all randomized patients who attended the first treatment session.||||||.83
72328336|NCT03079531|144181244|OTHER|||||||0.01|||||||Wilcoxon signed rank test|||The null hypothesis is that there would be no difference in papule/pustule count at baseline and after 16 weeks of secukinumab; the alternative hypothesis is that there would be a difference. Using an alpha=0.05 and power=0.80 (two sided test), the sample size needed would be 20. Assuming a dropout rate of 20%, 24 patients would be needed to achieve sufficient sample size.||||0.01
72328337|NCT03079531|144181245|OTHER|||||||0.02|||||||Wilcoxon signed rank test|||||||0.02
72328338|NCT03079531|144181246|OTHER|||||||0.03|||||||Wilcoxon signed rank test|||||||0.03
72328339|NCT03079531|144181247|OTHER|||||||0.2|||||||Wilcoxon signed rank test|||||||0.2
72328340|NCT03079531|144181248|OTHER||||||<|0.001|||||||Wilcoxon signed rank test|||||||<0.001
72328341|NCT03079531|144181250|OTHER|||||||0.56|||||||Wilcoxon signed rank test|||||||0.56
72328342|NCT01198574|144181258|SUPERIORITY_OR_OTHER||||||<|0.05|||||||GLM for repeated measures|The Hb concentration at Week 0, Week 6 and Week 12 are analyzed using GLM repeated measures.||"Null Hypothesis~1. Haemoglobin level was not influenced by sub-clinical inflammation during iron supplementation in the anaemic adolescent school girls~2. Vitamin A does not improve the haemoglobin level of the anaemic schoolgirls during iron supplementation in the presence of inflammation."||||<0.05
72420453|NCT04270747|144352532|OTHER||Difference between means|-1.2|||||TWO_SIDED|90.0|-3.2|0.8|||||Estimated using ANCOVA model adjusted for the stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA as covariates.|Difference in mean change from Baseline at Week 48.||0.8|-3.2|
72420454|NCT04270747|144352532|OTHER||Difference between means|-1.5|||||TWO_SIDED|2.0|-3.4|0.5|||||Estimated using ANCOVA model adjusted for the stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA as covariates.|Difference in mean change from Baseline at Week 52.||0.5|-3.4|
72420455|NCT04270747|144352532|OTHER||Difference between means|-1.5|||||TWO_SIDED|90.0|-3.0|0.0|||||Estimated using ANCOVA model adjusted for the stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA as covariates.|Difference in mean change from Baseline at Week 4.||0.0|-3.0|
72420456|NCT04270747|144352532|OTHER||Difference between means|-1.9|||||TWO_SIDED|90.0|-3.6|-0.2|||||Estimated using ANCOVA model adjusted for the stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA as covariates.|Difference in mean change from Baseline at Week 8.||-0.2|-3.6|
72420457|NCT04270747|144352532|OTHER||Difference between means|-0.3|||||TWO_SIDED|90.0|-2.1|1.5|||||Estimated using ANCOVA model adjusted for the stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA as covariates.|Difference in mean change from Baseline at Week 16.||1.5|-2.1|
72420458|NCT04270747|144352532|OTHER||Difference between means|0.0|||||TWO_SIDED|90.0|-1.9|2.0|||||Estimated using ANCOVA model adjusted for the stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA as covariates.|Difference in mean change from Baseline at Week 24.||2.0|-1.9|
72328343|NCT01198574|144181259|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||GLM for repeated measures ANOVA|||"Null hypothesis~1. Iron status indicator (serum ferritin) was not influenced by sub-clinical inflammation during iron supplementation in the anaemic adolescent school girls~2. Vitamin A does not improve the iron status indicator (serum ferritin) concentration of the anaemic schoolgirls during iron supplementation in the presence of inflammation."||||<0.05
72328344|NCT01198574|144181260|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||GLM for repeated measures ANOVA|||"Null Hypothesis~1. iron status indicator (sTfR) was not influenced by sub-clinical inflammation during iron supplementation in the anaemic adolescent school girls~2. Vitamin A does not improve iron status indicator (sTfR) of the anaemic schoolgirls during iron supplementation in the presence of inflammation."||||<0.05
72328345|NCT00556439|144181265|OTHER|Kaplan-Meier curves of relapse free survival were constructed, and differences in treatment arms compared using the logrank test. The analysis of the primary outcome was based upon intent to treat.||||||0.049||||||The p value of 0.049 reflects comparison of relapse free survival of abatacept versus placebo in giant cell arteritis.|Log Rank|||The planned sample size was determined by the minimally clinically meaningful result (i.e., an approximate 30% improvement in relapse-free survival) to be detected utilizing a one-sided alpha of 0.1. Kaplan-Meier curves of RFS were constructed for each stratum, and differences in treatment arms compared using the logrank test. The analysis of the primary outcome was based upon intent to treat.||||0.049
72328346|NCT00556439|144181265|OTHER|Kaplan-Meier curves of relapse free survival were constructed, and differences in treatment arms compared using the logrank test. The analysis of the primary outcome was based upon intent to treat.||||||0.853||||||The p value of 0.853 reflects comparison of relapse free survival of abatacept versus placebo in Takayasu arteritis.|Log Rank|||The planned sample size was determined by the minimally clinically meaningful result (i.e., an approximate 30% improvement in relapse-free survival) to be detected utilizing a one-sided alpha of 0.1. Kaplan-Meier curves of RFS were constructed for each stratum, and differences in treatment arms compared using the logrank test. The analysis of the primary outcome was based upon intent to treat.||||0.853
72328347|NCT00325130|144181272|NON_INFERIORITY_OR_EQUIVALENCE|"The difference in seroconversion rates (concomitant group -~nonconcomitant group) must be greater than -5%"|||||<|0.001||95.0||||Since p\<0.05, the hypothesis of noninferiority is accepted for this outcome.|Miettinen & Nurminen|Miettinen \& Nurminen method for difference in proportions, Stat Med 1985;4:213-26||||||<0.001
72328348|NCT00325130|144181274|NON_INFERIORITY_OR_EQUIVALENCE|"The difference in seroconversion rates (concomitant group -~nonconcomitant group) must be greater than -5%"|||||<|0.001||95.0||||Since p\<0.05, the hypothesis of noninferiority is accepted for this outcome.|Miettinen & Nurminen|Miettinen \& Nurminen method for difference in proportions, Stat Med 1985;4:213-26||||||<0.001
72328349|NCT00325130|144181275|NON_INFERIORITY_OR_EQUIVALENCE|"The difference in seroconversion rates (concomitant group -~nonconcomitant group) must be greater than -5%"|||||<|0.001||95.0||||Since p\<0.05, the hypothesis of noninferiority is accepted for this outcome.|Miettinen & Nurminen|Miettinen \& Nurminen method for difference in proportions, Stat Med 1985;4:213-26||||||<0.001
72328350|NCT00325130|144181276|NON_INFERIORITY_OR_EQUIVALENCE|"The difference in seroconversion rates (concomitant group -~nonconcomitant group) must be greater than -5%"|||||<|0.001||95.0||||Since p\<0.05, the hypothesis of noninferiority is accepted for this outcome.|Miettinen & Nurminen|Miettinen \& Nurminen method for difference in proportions, Stat Med 1985;4:213-26||||||<0.001
72420459|NCT04270747|144352532|OTHER||Difference between means|-1.9|||||TWO_SIDED|90.0|-4.0|0.2|||||Estimated using ANCOVA model adjusted for the stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA as covariates.|Difference in mean change from Baseline at Week 32.||0.2|-4.0|
72420460|NCT04270747|144352532|OTHER||Difference between means|0.0|||||TWO_SIDED|90.0|-2.2|2.2|||||Estimated using ANCOVA model adjusted for the stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA as covariates.|Difference in mean change from Baseline at Week 40.||2.2|-2.2|
72420461|NCT04270747|144352532|OTHER||Difference between means|-0.6|||||TWO_SIDED|90.0|-2.9|1.7|||||Estimated using ANCOVA model adjusted for the stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA as covariates.|Difference in mean change from Baseline at Week 48.||1.7|-2.9|
72420462|NCT04270747|144352532|OTHER||Difference between means|-1.2|||||TWO_SIDED|90.0|-3.5|1.1|||||Estimated using ANCOVA model adjusted for the stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA as covariates.|Difference in mean change from Baseline at Week 52.||1.1|-3.5|
72420463|NCT04270747|144352533|OTHER||Risk Difference (RD)|-3.4|||||TWO_SIDED|90.0|-9.8|3.1|||||Estimated using the stratified Newcombe confidence limits (with Mantel-Haenszel weights) adjusting for stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA (BCVA \< 64 letters, BCVA ≥ 64 letters).|Risk difference in percentage of participants who gained at least 10 letters of vision at Week 8.||3.1|-9.8|
72420464|NCT04270747|144352534|OTHER||Risk Difference (RD)|-5.3|||||TWO_SIDED|90.0|-13.6|2.5|||||Estimated using the stratified Newcombe confidence limits (with Mantel-Haenszel weights) adjusting for stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA (BCVA \< 64 letters, BCVA ≥ 64 letters).|Risk difference in percentage of participants who gained at least 15 letters of vision at Week 52.||2.5|-13.6|
72420465|NCT04270747|144352534|OTHER||Risk Difference (RD)|-5.2|||||TWO_SIDED|90.0|-14.4|4.2|||||Estimated using the stratified Newcombe confidence limits (with Mantel-Haenszel weights) adjusting for stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA (BCVA \< 64 letters, BCVA ≥ 64 letters).|Risk difference in percentage of participants who gained at least 15 letters of vision at Week 52.||4.2|-14.4|
72420466|NCT04270747|144352535|OTHER||Difference between means|-0.048|||||TWO_SIDED|90.0|-0.734|0.638|||||Estimated using ANCOVA model with treatment, Baseline CNV measurement and the stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA (BCVA \< 64 letters, BCVA ≥ 64 letters) as covariates.|Difference in mean change from Baseline at Week 8.||0.638|-0.734|
72420467|NCT04270747|144352535|OTHER||Difference between means|0.431|||||TWO_SIDED|90.0|-0.367|1.229|||||Estimated using ANCOVA model with treatment, Baseline CNV measurement and the stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA (BCVA \< 64 letters, BCVA ≥ 64 letters) as covariates.|Difference in mean change from Baseline at Week 16.||1.229|-0.367|
72420468|NCT04270747|144352535|OTHER||Difference between means|0.197|||||TWO_SIDED|90.0|-0.625|1.019|||||Estimated using ANCOVA model with treatment, Baseline CNV measurement and the stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA (BCVA \< 64 letters, BCVA ≥ 64 letters) as covariates.|Difference in mean change from Baseline at Week 24.||1.019|-0.625|
72420469|NCT04270747|144352535|OTHER||Difference between means|0.156|||||TWO_SIDED|2.0|-0.561|0.872|||||Estimated using ANCOVA model with treatment, Baseline CNV measurement and the stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA (BCVA \< 64 letters, BCVA ≥ 64 letters) as covariates.|Difference in mean change from Baseline at Week 52.||0.872|-0.561|
72420470|NCT04270747|144352535|OTHER||Difference between means|0.105|||||TWO_SIDED|90.0|-0.682|0.891|||||Estimated using ANCOVA model with treatment, Baseline CNV measurement and the stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA (BCVA \< 64 letters, BCVA ≥ 64 letters) as covariates.|Difference in mean change from Baseline at Week 8.||0.891|-0.682|
72420471|NCT04270747|144352535|OTHER||Difference between means|0.245|||||TWO_SIDED|90.0|-0.667|1.158|||||Estimated using ANCOVA model with treatment, Baseline CNV measurement and the stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA (BCVA \< 64 letters, BCVA ≥ 64 letters) as covariates.|Difference in mean change from Baseline at Week 16.||1.158|-0.667|
72420472|NCT04270747|144352535|OTHER||Difference between means|-0.116|||||TWO_SIDED|90.0|-1.065|0.834|||||Estimated using ANCOVA model with treatment, Baseline CNV measurement and the stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA (BCVA \< 64 letters, BCVA ≥ 64 letters) as covariates.|Difference in mean change from Baseline at Week 24.||0.834|-1.065|
72328351|NCT00325130|144181277|NON_INFERIORITY_OR_EQUIVALENCE|"The difference in seroconversion rates (concomitant group -~nonconcomitant group) must be greater than -10%"|||||<|0.001||95.0||||Since p\<0.05, the hypothesis of noninferiority is accepted for this outcome.|Miettinen & Nurminen|Miettinen \& Nurminen method for difference in proportions, Stat Med 1985;4:213-26||||||<0.001
72420473|NCT04270747|144352535|OTHER||Difference between means|0.647|||||TWO_SIDED|90.0|-0.186|1.479|||||Estimated using ANCOVA model with treatment, Baseline CNV measurement and the stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA (BCVA \< 64 letters, BCVA ≥ 64 letters) as covariates.|Difference in mean change from Baseline at Week 52.||1.479|-0.186|
72420474|NCT04270747|144352536|OTHER||Difference between means|6.2|||||TWO_SIDED|90.0|-5.6|17.9|||||Estimated using ANCOVA model with treatment, Baseline CST measurement and the stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA (BCVA \< 64 letters, BCVA ≥ 64 letters) as covariates.|Difference in mean change from Baseline at Week 4.||17.9|-5.6|
72420475|NCT04270747|144352536|OTHER||Difference between means|1.3|||||TWO_SIDED|90.0|-11.0|13.5|||||Estimated using ANCOVA model with treatment, Baseline CST measurement and the stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA (BCVA \< 64 letters, BCVA ≥ 64 letters) as covariates.|Difference in mean change from Baseline at Week 8.||13.5|-11.0|
72420476|NCT04270747|144352536|OTHER||Difference between means|1.9|||||TWO_SIDED|90.0|-12.9|16.6|||||Estimated using ANCOVA model with treatment, Baseline CST measurement and the stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA (BCVA \< 64 letters, BCVA ≥ 64 letters) as covariates.|Difference in mean change from Baseline at Week 16.||16.6|-12.9|
72328352|NCT00325130|144181278|NON_INFERIORITY_OR_EQUIVALENCE|"The difference in seroconversion rates (concomitant group -~nonconcomitant group) must be greater than -10%"|||||<|0.001||95.0||||Since p\<0.05, the hypothesis of noninferiority is accepted for this outcome.|Miettinen & Nurminen|Miettinen \& Nurminen method for difference in proportions, Stat Med 1985;4:213-26||||||<0.001
72420477|NCT04270747|144352536|OTHER||Difference between means|0.1|||||TWO_SIDED|90.0|-14.1|14.4|||||Estimated using ANCOVA model with treatment, Baseline CST measurement and the stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA (BCVA \< 64 letters, BCVA ≥ 64 letters) as covariates.|Difference in mean change from Baseline at Week 24.||14.4|-14.1|
72420478|NCT04270747|144352536|OTHER||Difference between means|-1.2|||||TWO_SIDED|90.0|-15.3|12.9|||||Estimated using ANCOVA model with treatment, Baseline CST measurement and the stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA (BCVA \< 64 letters, BCVA ≥ 64 letters) as covariates.|Difference in mean change from Baseline at Week 32.||12.9|-15.3|
72420479|NCT04270747|144352536|OTHER||Difference between means|0.2|||||TWO_SIDED|90.0|-13.7|14.1|||||Estimated using ANCOVA model with treatment, Baseline CST measurement and the stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA (BCVA \< 64 letters, BCVA ≥ 64 letters) as covariates.|Difference in mean change from Baseline at Week 40.||14.1|-13.7|
72328353|NCT00325130|144181279|NON_INFERIORITY_OR_EQUIVALENCE|"The difference in seroconversion rates (concomitant group -~nonconcomitant group) must be greater than -10%"|||||<|0.001||95.0||||Since p\<0.05, the hypothesis of noninferiority is accepted for this outcome.|Miettinen & Nurminen|Miettinen \& Nurminen method for difference in proportions, Stat Med 1985;4:213-26||||||<0.001
72328354|NCT00325130|144181280|NON_INFERIORITY_OR_EQUIVALENCE|"The difference in seroconversion rates (concomitant group -~nonconcomitant group) must be greater than -10%"|||||<|0.001||95.0||||Since p\<0.05, the hypothesis of noninferiority is accepted for this outcome.|Miettinen & Nurminen|Miettinen \& Nurminen method for difference in proportions, Stat Med 1985;4:213-26||||||<0.001
72328355|NCT00325130|144181281|NON_INFERIORITY_OR_EQUIVALENCE|"The difference in seroconversion rates (concomitant group -~nonconcomitant group) must be greater than -10%"|||||<|0.001||95.0||||Since p\<0.05, the hypothesis of noninferiority is accepted for this outcome.|Miettinen & Nurminen|Miettinen \& Nurminen method for difference in proportions, Stat Med 1985;4:213-26||||||<0.001
72328356|NCT00325130|144181282|NON_INFERIORITY_OR_EQUIVALENCE|"The difference in seroconversion rates (concomitant group -~nonconcomitant group) must be greater than -10%"|||||<|0.001||95.0||||Since p\<0.05, the hypothesis of noninferiority is accepted for this outcome.|Miettinen & Nurminen|Miettinen \& Nurminen method for difference in proportions, Stat Med 1985;4:213-26||||||<0.001
72328357|NCT00325130|144181283|NON_INFERIORITY_OR_EQUIVALENCE|"The ratio of GMTs (concomitant group / nonconcomitant group)~must be greater than 0.5."|||||<|0.001||95.0||||Since p\<0.05, the hypothesis of noninferiority is accepted for this outcome.|ANOVA|ANOVA on natural log titer with fixed effects for region, vaccination group and their interaction.||||||<0.001
72328358|NCT00325130|144181284|NON_INFERIORITY_OR_EQUIVALENCE|"The ratio of GMTs (concomitant group / nonconcomitant group)~must be greater than 0.5."|||||<|0.001||95.0||||Since p\<0.05, the hypothesis of noninferiority is accepted for this outcome.|ANOVA|ANOVA on natural log titer with fixed effects for region, vaccination group and their interaction.||||||<0.001
72328359|NCT00325130|144181285|NON_INFERIORITY_OR_EQUIVALENCE|"The ratio of GMTs (concomitant group / nonconcomitant group)~must be greater than 0.5."|||||<|0.001||95.0||||Since p\<0.05, the hypothesis of noninferiority is accepted for this outcome.|ANOVA|ANOVA on natural log titer with fixed effects for region, vaccination group and their interaction.||||||<0.001
72328360|NCT00325130|144181286|NON_INFERIORITY_OR_EQUIVALENCE|"The ratio of GMTs (concomitant group / nonconcomitant group)~must be greater than 0.5."|||||<|0.001||95.0||||Since p\<0.05, the hypothesis of noninferiority is accepted for this outcome.|ANOVA|ANOVA on natural log titer with fixed effects for region, vaccination group and their interaction.||||||<0.001
72328361|NCT00325130|144181287|NON_INFERIORITY_OR_EQUIVALENCE|"The ratio of GMTs (concomitant group / nonconcomitant group)~must be greater than 0.67."|||||<|0.001||95.0||||Since p\<0.05, the hypothesis of noninferiority is accepted for this outcome.|ANOVA|ANOVA on natural log titer with fixed effects for region, vaccination group and their interaction.||||||<0.001
72328362|NCT00325130|144181288|NON_INFERIORITY_OR_EQUIVALENCE|"The ratio of GMTs (concomitant group / nonconcomitant group)~must be greater than 0.67."|||||<|0.001||95.0||||Since p\<0.05, the hypothesis of noninferiority is accepted for this outcome.|ANOVA|ANOVA on natural log titer with fixed effects for region, vaccination group and their interaction.||||||<0.001
72328363|NCT00325130|144181289|NON_INFERIORITY_OR_EQUIVALENCE|"The ratio of GMTs (concomitant group / nonconcomitant group)~must be greater than 0.67."|||||<|0.001||95.0||||Since p\<0.05, the hypothesis of noninferiority is accepted for this outcome.|ANOVA|ANOVA on natural log titer with fixed effects for region, vaccination group and their interaction.||||||<0.001
72328364|NCT00325130|144181290|NON_INFERIORITY_OR_EQUIVALENCE|"The ratio of GMTs (concomitant group / nonconcomitant group)~must be greater than 0.67."|||||<|0.001||95.0||||Since p\<0.05, the hypothesis of noninferiority is accepted for this outcome.|ANOVA|ANOVA on natural log titer with fixed effects for region, vaccination group and their interaction.||||||<0.001
72328365|NCT03265145|144181308|OTHER||Hazard Ratio (HR)|1.23|||||TWO_SIDED|95.0|0.87|1.72|||||"Cox proportional hazards model with baseline ICS prior use as a covariate was used to estimate the hazard ratio (HR) and the two-sided 95% Wald confidence interval (CI).~Ratio: Stiolto Respimat/triple therapy."|||1.72|0.87|
72328366|NCT03265145|144181309|OTHER||adjusted annual rate ratio|1.41|||||TWO_SIDED|95.0|0.97|2.04|||||Ratio: Stiolto Respimat/triple therapy|||2.04|0.97|
72328367|NCT03265145|144181310|OTHER||Hazard Ratio (HR)|1.11|||||TWO_SIDED|95.0|0.62|2.0|||||"Cox proportional hazards model with baseline ICS prior use as a covariate was used to estimate the hazard ratio (HR) and the two-sided 95% Wald confidence interval (CI).~Ratio: Stiolto Respimat/triple therapy."|||2.00|0.62|
72328368|NCT03265145|144181311|OTHER||adjusted annual rate ratio|1.08|||||TWO_SIDED|95.0|0.58|2.01|||||Ratio: Stiolto Respimat/triple therapy|||2.01|0.58|
72328369|NCT03265145|144181312|OTHER||Risk Ratio (RR)|1.21|||||TWO_SIDED|95.0|0.89|1.64|||||Ratio: Stiolto Respimat/triple therapy|A Cochran-Mantel-Haenszel (CMH) model with baseline ICS prior use as stratum was used to estimate the Risk Ratio (RR) (Stiolto Respimat versus triple therapy) of moderate or severe COPD exacerbations along with 95% CI.||1.64|0.89|
72328370|NCT03265145|144181312|OTHER||Risk Difference (RD)|0.036|||||TWO_SIDED|95.0|-0.022|0.094|||||Ratio: Stiolto Respimat/triple therapy|A Cochran-Mantel-Haenszel (CMH) model with baseline ICS prior use as stratum was used to estimate the Risk Difference (Stiolto Respimat versus triple therapy) of moderate or severe COPD exacerbations along with 95% CI.||0.094|-0.022|
72328371|NCT03159468|144181324|OTHER|||||||0.041||||||This p-value is for the main effect of beverage condition.|ANOVA|||||||.041
72328372|NCT03159468|144181324|OTHER|||||||0.16||||||This p-value is for the main effect of intervention condition.|ANOVA|||||||.160
72328373|NCT03159468|144181324|OTHER|||||||0.462||||||This p-value is for the beverage condition by intervention condition interaction.|ANOVA|||||||.462
72328374|NCT00802997|144181328|SUPERIORITY_OR_OTHER|||||||0.035||95.0|||||t-test, 2 sided|||||||0.035
72328375|NCT03046927|144181381|EQUIVALENCE|p values were obtained using generalized linear model with GEE for repeated measures.|Mean Difference (Net)|0.08|||<|0.001|TWO_SIDED||||||generalized linear model with dependent||Trend analysis was performed using generalized linear model with GEE for repeated measures.|||||<0.001
72328376|NCT03046927|144181382|OTHER||trend analysis|0.04|||<|0.01|TWO_SIDED|||||The threshold for statistical significance was p=0.05|generalized linear model|p values were obtained using generalized linear model with GEE for repeated measures.|Trend analysis was performed using generalized linear model with GEE for repeated measures.|||||<0.01
72328377|NCT03046927|144181383|OTHER|p values were derived from trend analysis using generalized linear models|Mean Difference (Net)|0.507||||0.0241|TWO_SIDED|95.0|0.066|0.947||The p-value was derived from a statistical model adjusted for age, sex, and BMI|General linear models|||||0.947|0.066|0.0241
72420480|NCT04270747|144352536|OTHER||Difference between means|7.0|||||TWO_SIDED|90.0|-7.4|21.4|||||Estimated using ANCOVA model with treatment, Baseline CST measurement and the stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA (BCVA \< 64 letters, BCVA ≥ 64 letters) as covariates.|Difference in mean change from Baseline at Week 48.||21.4|-7.4|
72420481|NCT04270747|144352536|OTHER||Difference between means|1.6|||||TWO_SIDED|2.0|-9.3|12.5|||||Estimated using ANCOVA model with treatment, Baseline CST measurement and the stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA (BCVA \< 64 letters, BCVA ≥ 64 letters) as covariates.|Difference in mean change from Baseline at Week 52.||12.5|-9.3|
72420482|NCT04270747|144352536|OTHER||Difference between means|6.3|||||TWO_SIDED|90.0|-7.4|20.0|||||Estimated using ANCOVA model with treatment, Baseline CST measurement and the stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA (BCVA \< 64 letters, BCVA ≥ 64 letters) as covariates.|Difference in mean change from Baseline at Week 4.||20.0|-7.4|
72420483|NCT04270747|144352536|OTHER||Difference between means|-5.1|||||TWO_SIDED|90.0|-19.3|9.1|||||Estimated using ANCOVA model with treatment, Baseline CST measurement and the stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA (BCVA \< 64 letters, BCVA ≥ 64 letters) as covariates.|Difference in mean change from Baseline at Week 8.||9.1|-19.3|
72420484|NCT04270747|144352536|OTHER||Difference between means|-3.8|||||TWO_SIDED|90.0|-20.9|13.3|||||Estimated using ANCOVA model with treatment, Baseline CST measurement and the stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA (BCVA \< 64 letters, BCVA ≥ 64 letters) as covariates.|Difference in mean change from Baseline at Week 16.||13.3|-20.9|
72420485|NCT04270747|144352536|OTHER||Difference between means|-6.0|||||TWO_SIDED|90.0|-22.6|10.6|||||Estimated using ANCOVA model with treatment, Baseline CST measurement and the stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA (BCVA \< 64 letters, BCVA ≥ 64 letters) as covariates.|Difference in mean change from Baseline at Week 24.||10.6|-22.6|
72420486|NCT04270747|144352536|OTHER||Difference between means|-7.0|||||TWO_SIDED|90.0|-23.3|9.3|||||Estimated using ANCOVA model with treatment, Baseline CST measurement and the stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA (BCVA \< 64 letters, BCVA ≥ 64 letters) as covariates.|Difference in mean change from Baseline at Week 32.||9.3|-23.3|
72420487|NCT04270747|144352536|OTHER||Difference between means|-6.5|||||TWO_SIDED|90.0|-22.8|9.8|||||Estimated using ANCOVA model with treatment, Baseline CST measurement and the stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA (BCVA \< 64 letters, BCVA ≥ 64 letters) as covariates.|Difference in mean change from Baseline at Week 40.||9.8|-22.8|
72420488|NCT04270747|144352536|OTHER||Difference between means|-0.5|||||TWO_SIDED|90.0|-17.3|16.2|||||Estimated using ANCOVA model with treatment, Baseline CST measurement and the stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA (BCVA \< 64 letters, BCVA ≥ 64 letters) as covariates.|Difference in mean change from Baseline at Week 48.||16.2|-17.3|
72420489|NCT04270747|144352536|OTHER||Difference between means|2.3|||||TWO_SIDED|90.0|-10.5|15.0|||||Estimated using ANCOVA model with treatment, Baseline CST measurement and the stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA (BCVA \< 64 letters, BCVA ≥ 64 letters) as covariates.|Difference in mean change from Baseline at Week 52.||15.0|-10.5|
72420490|NCT05614089|144352543|SUPERIORITY|||||||0.43||||||Since this is one of two coprimary outcomes (this outcome and % time-in-range), a win (p\<0.025 for benefit) on either outcome will be considered to be a positive trial.|Regression, Linear|Multivariable generalized linear regression model adjusted for age at screening, study site, and % time in serious hypoglycemia at baseline||6-month (primary)||||0.43
72420491|NCT05614089|144352543|SUPERIORITY|||||||0.008||||||Since this is one of two coprimary outcomes (this outcome and % time-in-range), a win (p\<0.025 for benefit) on either outcome will be considered to be a positive trial.|Regression, Linear|Multivariable generalized linear regression model adjusted for age at screening, study site, and % time in serious hypoglycemia at baseline||12-month||||0.008
72420492|NCT05614089|144352544|SUPERIORITY|||||||0.71||||||Since this is one of two coprimary outcomes (this outcome and % time in serious hypoglycemia), a win (p\<0.025 for benefit) on either outcome will be considered to be a positive trial.|Regression, Linear|Multivariable generalized linear regression model adjusted for age at screening, study site, and % TIR at baseline||6-month (primary)||||0.71
72420493|NCT05614089|144352544|SUPERIORITY|||||||0.64||||||Since this is one of two coprimary outcomes (this outcome and % time in serious hypoglycemia), a win (p\<0.025 for benefit) on either outcome will be considered to be a positive trial.|Regression, Linear|Multivariable generalized linear regression model adjusted for age at screening, study site, and % TIR at baseline||12-month||||0.64
72420494|NCT05614089|144352545|SUPERIORITY|||||||0.54|||||||Regression, Linear|Multivariable generalized linear regression model adjusted for age at screening, study site, and % time in hypoglycemia at baseline||6-month||||0.54
72420495|NCT05614089|144352545|SUPERIORITY|||||||0.07|||||||Regression, Linear|Multivariable generalized linear regression model adjusted for age at screening, study site, and % time in hypoglycemia at baseline||12-month||||0.07
72420496|NCT05614089|144352546|SUPERIORITY|||||||0.58|||||||Regression, Linear|Multivariable generalized linear regression model adjusted for age at screening, study site, and % time above range at baseline||6-month||||0.58
72420497|NCT05614089|144352546|SUPERIORITY|||||||0.21|||||||Regression, Linear|Multivariable generalized linear regression model adjusted for age at screening, study site, and % time above range at baseline||12-month||||0.21
72420498|NCT05614089|144352547|SUPERIORITY|||||||0.7|||||||Regression, Linear|Multivariable generalized linear regression model adjusted for age at screening, study site, and number of nocturnal events at baseline||6-month||||0.70
72420499|NCT05614089|144352547|SUPERIORITY|||||||0.02|||||||Regression, Linear|Multivariable generalized linear regression model adjusted for age at screening, study site, and number of nocturnal events at baseline||12-month||||0.02
72420500|NCT05614089|144352548|SUPERIORITY|||||||0.81|||||||Regression, Linear|Multivariable generalized linear regression model adjusted for age at screening, study site, and HbA1c at baseline||6-month||||0.81
72420501|NCT05614089|144352548|SUPERIORITY|||||||0.29|||||||Regression, Linear|Multivariable generalized linear regression model adjusted for age at screening, study site, and HbA1c at baseline||12-month||||0.29
72420502|NCT05614089|144352549|SUPERIORITY|||||||0.98|||||||Negative Binomial Regression|Negative binomial regression model adjusted for age at screening and study site||Through 6-month||||0.98
72420503|NCT05614089|144352549|SUPERIORITY|||||||0.61|||||||Negative Binomial Regression|Negative binomial regression model adjusted for age at screening and study site||Through 12-month||||0.61
72420504|NCT05614089|144352550|SUPERIORITY|||||||0.83|||||||Negative Binomial Regression|Negative binomial regression model adjusted for age at screening and study site||Through 6-month||||0.83
72420505|NCT05614089|144352550|SUPERIORITY|||||||0.09|||||||Negative Binomial Regression|Negative binomial regression model adjusted for age at screening and study site||Through 12-month||||0.09
72420506|NCT05614089|144352551|SUPERIORITY|||||||0.95|||||||Regression, Linear|Multivariable generalized linear regression model adjusted for age at screening, study site, and PedsQL 3.2 DM Diabetes Symptoms score at baseline||6-month||||0.95
72420507|NCT05614089|144352551|SUPERIORITY|||||||0.73|||||||Regression, Linear|Multivariable generalized linear regression model adjusted for age at screening, study site, and PedsQL 3.2 DM Diabetes Symptoms score at baseline||12-month||||0.73
72420508|NCT05614089|144352552|SUPERIORITY|||||||0.81|||||||Regression, Linear|Multivariable generalized linear regression model adjusted for age at screening, study site, and PedsQL 3.2 DM Diabetes Management score at baseline||6-month||||0.81
72420509|NCT05614089|144352552|SUPERIORITY|||||||0.44|||||||Regression, Linear|Multivariable generalized linear regression model adjusted for age at screening, study site, and PedsQL 3.2 DM Diabetes Management score at baseline||12-month||||0.44
72420510|NCT05614089|144352553|SUPERIORITY|||||||0.04|||||||Regression, Linear|Multivariable generalized linear regression model adjusted for age at screening, study site, and ITSQ at baseline||6-month||||0.04
72420511|NCT05614089|144352553|SUPERIORITY|||||||0.1|||||||Regression, Linear|Multivariable generalized linear regression model adjusted for age at screening, study site, and ITSQ at baseline||12-month||||0.10
72420512|NCT04058353|144352632|SUPERIORITY||Least Squares (LS) Mean Difference|3.5|||<|0.0001|TWO_SIDED|95.0|2.2|4.7|||Mixed-effects model for repeated measure|||||4.7|2.2|<0.0001
72420513|NCT04058353|144352633|SUPERIORITY||LS Mean Difference|-23.1|||<|0.0001|TWO_SIDED|95.0|-26.1|-20.1|||Mixed-effects model for repeated measure|||||-20.1|-26.1|<0.0001
72420514|NCT04058353|144352635|SUPERIORITY||LS Mean Difference|8.7|||<|0.0001|TWO_SIDED|95.0|5.3|12.1|||Mixed-effects model for repeated measure|||||12.1|5.3|<0.0001
72420515|NCT00279201|144352643|SUPERIORITY_OR_OTHER|||||||0.005||95.0|||||ANCOVA|P-value from ANCOVA, baseline value as covariate. Response = Treatment + Baseline + Country + thiazolidinedione (TZD) use + Sulfonylurea (sulfo) use.||||||0.005
72420516|NCT00279201|144352644|SUPERIORITY_OR_OTHER|||||||0.04||95.0|||||Log Rank|Stratified by country, thiazolidinedione (TZD) use, sulfo use.||||||0.040
72420517|NCT00279201|144352645|SUPERIORITY_OR_OTHER|||||||0.271||95.0|||||ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.271
72420518|NCT00279201|144352645|SUPERIORITY_OR_OTHER|||||||0.99||95.0|||||ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.990
72420519|NCT00279201|144352646|SUPERIORITY_OR_OTHER|||||||0.005||95.0|||||ANCOVA|Response = Treatment + Baseline + Country + TZD use + Sulfo use.||||||0.005
72420520|NCT00279201|144352647|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||P-value for \<=7.0%.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel statistic controlling for country, TZD use, and sulfo use.||||||0.002
72420521|NCT00279201|144352647|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for \<7.0%.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel statistic controlling for country, TZD use, and sulfo use.||||||<0.001
72420522|NCT00279201|144352647|SUPERIORITY_OR_OTHER|||||||0.174||95.0||||P-value is for \<=6.5%.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel statistic controlling for country, TZD use, and sulfo use.||||||0.174
72420523|NCT00279201|144352648|SUPERIORITY_OR_OTHER|||||||0.416||95.0||||P-value for baseline.|ANOVA|ANOVA with treatment, country, TZD use, and sulfo use in model.||||||0.416
72420524|NCT00279201|144352648|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Week 12.|ANCOVA|Response = Treatment + Baseline + Country + TZD use + sulfo use.||||||<0.001
72420525|NCT00279201|144352648|SUPERIORITY_OR_OTHER|||||||0.003||95.0||||P-value for Week 24.|ANCOVA|Response = Treatment + Baseline + Country + TZD use + sulfo use.||||||0.003
72420526|NCT00279201|144352648|SUPERIORITY_OR_OTHER|||||||0.005||95.0||||P-value for endpoint.|ANCOVA|Response = Treatment + Baseline + Country + TZD use + sulfo use.||||||0.005
72420527|NCT00279201|144352649|SUPERIORITY_OR_OTHER|||||||0.179||95.0||||P-value is for Baseline mean fasting blood glucose.|ANOVA|ANOVA with treatment, country, TZD use and sulfo use in model.||||||0.179
72420528|NCT00279201|144352649|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for mean fasting blood glucose.|ANCOVA|Response = Treatment + Baseline + Country + TZD use + sulfo use.||||||<0.001
72420529|NCT00279201|144352649|SUPERIORITY_OR_OTHER|||||||0.7||95.0||||P-value is for Baseline AM 2-hour postprandial BG.|ANOVA|ANOVA with treatment, country, TZD use and sulfo use in model.||||||0.700
72420530|NCT00279201|144352649|SUPERIORITY_OR_OTHER|||||||0.016||95.0||||P-value for AM 2-hour postprandial blood glucose.|ANCOVA|Response = Treatment + Baseline + Country + TZD use + sulfo use.||||||0.016
72420531|NCT00279201|144352649|SUPERIORITY_OR_OTHER|||||||0.971||95.0||||P-value is for Baseline midday premeal BG.|ANOVA|ANOVA with treatment, country, TZD use and sulfo use in model.||||||0.971
72420532|NCT00279201|144352649|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Midday premeal blood glucose (BG).|ANCOVA|Response = Treatment + Baseline + Country + TZD use + sulfo use.||||||<0.001
72420533|NCT00279201|144352649|SUPERIORITY_OR_OTHER|||||||0.759||95.0||||P-value is for Baseline midday 2-hour postprandial BG|ANOVA|ANOVA with treatment, country, TZD use and sulfo use in model.||||||0.759
72420534|NCT00279201|144352649|SUPERIORITY_OR_OTHER|||||||0.514||95.0||||P-value Midday 2-hour postprandial BG.|ANCOVA|Response = Treatment + Baseline + Country + TZD use + sulfo use.||||||0.514
72420535|NCT00279201|144352649|SUPERIORITY_OR_OTHER|||||||0.321||95.0||||P-value is for Baseline evening pre-meal BG.|ANOVA|ANOVA with treatment, country, TZD use, and sulfo use in model.||||||0.321
72420536|NCT00279201|144352649|SUPERIORITY_OR_OTHER|||||||0.161||95.0||||P-value for Evening pre-meal blood glucose.|ANCOVA|Response = Treatment + Baseline + Country + TZD use + sulfo use.||||||0.161
72420537|NCT00279201|144352649|SUPERIORITY_OR_OTHER|||||||0.297||95.0||||P-value is for Baseline evening 2hour postprandial.|ANOVA|ANOVA with treatment, country, TZD use, and sulfo use in model.||||||0.297
72328378|NCT03046927|144181384|OTHER|p values were obtained from a generalized linear model with repeated measures|Mean Difference (Net)|10.37||||0.23|TWO_SIDED|95.0|-6.4|27.13||The p-value was derived from a statistical model adjusted for age, sex, and BMI|Regression, Linear|||||27.13|-6.40|0.23
72328379|NCT03046927|144181385|OTHER||trend analysis|0.02|||<|0.001|TWO_SIDED||||||generalized linear model|p values were obtained using generalized linear model with GEE for repeated measures.|||Trend analysis was obtained using generalized linear model GEE.|||<0.001
72328380|NCT01848977|144181410|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||t-test, 1 sided|||Unpaired t-test was used to compare the difference between SrO2 and StO2.||||<0.05
72328381|NCT02522429|144181482|OTHER|||||||0.05||||||Statistic adjusted at familywise level alpha of 0.05 with a Gaussian Random Field Cluster Correction (Z \> 2.7)|t-test, 1 sided|||||||0.05
72328382|NCT02522429|144181483|OTHER||||||<|0.05||||||Statistic adjusted at familywise level alpha of 0.05 with a Gaussian Random Field Cluster Correction (Z \> 2.7). All significant voxels have an associated p-value smaller-or-equal to 0.05 (corrected for multiplicity).|t-test, 1 sided|||||||<0.05
72328383|NCT02522429|144181485|OTHER||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||Maximum CRS-R prior to LIFUP compared to Maximum CRS-R after LIFUP||||<0.05
72328384|NCT00500357|144181489|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 95 %confidence interval for the back-transformed GMFR was \> 0.5 (2-fold criterion as a basis for comparison).|geometric mean fold rise|0.4|||||TWO_SIDED|95.0|0.28|0.56|||||Confidence Intervals (CI) for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 minus \[-\] Vax 1).|Serotype 1: Geometric mean fold rise (GMFR) was calculated using all participants with available data from both the Vax 1 and Vax 3 blood draws.||0.56|0.28|
72328385|NCT00500357|144181489|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 95 %confidence interval for the back-transformed GMFR was \> 0.5 (2-fold criterion as a basis for comparison).|geometric mean fold rise|0.8|||||TWO_SIDED|95.0|0.67|1.01|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 1).|Serotype 3: GMFR was calculated using all participants with available data from both the Vax 1 and Vax 3 blood draws.||1.01|0.67|
72328386|NCT00500357|144181489|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 95 %confidence interval for the back-transformed GMFR was \> 0.5 (2-fold criterion as a basis for comparison).|geometric mean fold rise|0.6|||||TWO_SIDED|95.0|0.44|0.72|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 1).|Serotype 4: Geometric mean fold rise (GMFR) was calculated using all participants with available data from both the Vax 1 and Vax 3 blood draws.||0.72|0.44|
72328387|NCT00500357|144181489|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 95 %confidence interval for the back-transformed GMFR was \> 0.5 (2-fold criterion as a basis for comparison).|geometric mean fold rise|0.4|||||TWO_SIDED|95.0|0.32|0.53|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 1).|Serotype 5: Geometric mean fold rise (GMFR) was calculated using all participants with available data from both the Vax 1 and Vax 3 blood draws.||0.53|0.32|
72328388|NCT00500357|144181489|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 95 %confidence interval for the back-transformed GMFR was \> 0.5 (2-fold criterion as a basis for comparison).|geometric mean fold rise|0.6|||||TWO_SIDED|95.0|0.45|0.91|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 1).|Serotype 6A: Geometric mean fold rise (GMFR) was calculated using all participants with available data from both the Vax 1 and Vax 3 blood draws.||0.91|0.45|
72328389|NCT00500357|144181489|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 95 %confidence interval for the back-transformed GMFR was \> 0.5 (2-fold criterion as a basis for comparison).|geometric mean fold rise|0.8|||||TWO_SIDED|95.0|0.56|1.01|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 1).|Serotype 6B: Geometric mean fold rise (GMFR) was calculated using all participants with available data from both the Vax 1 and Vax 3 blood draws.||1.01|0.56|
72328390|NCT00500357|144181489|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 95 %confidence interval for the back-transformed GMFR was \> 0.5 (2-fold criterion as a basis for comparison).|geometric mean fold rise|0.4|||||TWO_SIDED|95.0|0.25|0.65|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 1).|Serotype 7F: Geometric mean fold rise (GMFR) was calculated using all participants with available data from both the Vax 1 and Vax 3 blood draws.||0.65|0.25|
72328391|NCT00500357|144181489|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 95 %confidence interval for the back-transformed GMFR was \> 0.5 (2-fold criterion as a basis for comparison).|geometric mean fold rise|0.3|||||TWO_SIDED|95.0|0.16|0.4|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 1).|Serotype 9V: Geometric mean fold rise (GMFR) was calculated using all participants with available data from both the Vax 1 and Vax 3 blood draws.||0.40|0.16|
72328392|NCT00500357|144181489|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 95 %confidence interval for the back-transformed GMFR was \> 0.5 (2-fold criterion as a basis for comparison).|geometric mean fold rise|0.6|||||TWO_SIDED|95.0|0.4|0.78|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 1).|Serotype 14: Geometric mean fold rise (GMFR) was calculated using all participants with available data from both the Vax 1 and Vax 3 blood draws.||0.78|0.40|
72420538|NCT00279201|144352649|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value Evening 2-hour postprandial BG.|ANCOVA|Response = Treatment + Baseline + Country + TZD use + sulfo use.||||||<0.001
72420539|NCT00279201|144352649|SUPERIORITY_OR_OTHER|||||||0.199||95.0||||P-value is for Baseline 3 AM blood glucose.|ANOVA|ANOVA with treatment, country, TZD use, and sulfo use in model.||||||0.199
72328393|NCT00500357|144181489|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 95 %confidence interval for the back-transformed GMFR was \> 0.5 (2-fold criterion as a basis for comparison).|geometric mean fold rise|0.5|||||TWO_SIDED|95.0|0.4|0.65|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 1).|Serotype 18C: Geometric mean fold rise (GMFR) was calculated using all participants with available data from both the Vax 1 and Vax 3 blood draws.||0.65|0.40|
72328394|NCT00500357|144181489|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 95 %confidence interval for the back-transformed GMFR was \> 0.5 (2-fold criterion as a basis for comparison).|geometric mean fold rise|0.4|||||TWO_SIDED|95.0|0.3|0.48|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 1).|Serotype 19A: Geometric mean fold rise (GMFR) was calculated using all participants with available data from both the Vax 1 and Vax 3 blood draws.||0.48|0.30|
72328395|NCT00500357|144181489|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 95 %confidence interval for the back-transformed GMFR was \> 0.5 (2-fold criterion as a basis for comparison).|geometric mean fold rise|0.5|||||TWO_SIDED|95.0|0.35|0.67|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 1).|Serotype 19F: Geometric mean fold rise (GMFR) was calculated using all participants with available data from both the Vax 1 and Vax 3 blood draws.||0.67|0.35|
72328396|NCT00500357|144181489|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 95 %confidence interval for the back-transformed GMFR was \> 0.5 (2-fold criterion as a basis for comparison).|geometric mean fold rise|1.3|||||TWO_SIDED|95.0|0.86|1.86|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 1).|Serotype 23F: Geometric mean fold rise (GMFR) was calculated using all participants with available data from both the Vax 1 and Vax 3 blood draws.||1.86|0.86|
72328397|NCT00500357|144181492|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 95 %confidence interval for the back-transformed GMFR was \> 0.5 (2-fold criterion as a basis for comparison).|geometric mean fold rise|0.4|||||TWO_SIDED|95.0|0.34|0.57|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 2).|Serotype 1: GMFR was calculated using all participants with available data from both the Vax 2 and Vax 3 blood draws.||0.57|0.34|
72328398|NCT00500357|144181492|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 95 %confidence interval for the back-transformed GMFR was \> 0.5 (2-fold criterion as a basis for comparison).|geometric mean fold rise|0.8|||||TWO_SIDED|95.0|0.66|0.95|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 2).|Serotype 3: GMFR was calculated using all participants with available data from both the Vax 2 and Vax 3 blood draws.||0.95|0.66|
72328399|NCT00500357|144181492|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 95 %confidence interval for the back-transformed GMFR was \> 0.5 (2-fold criterion as a basis for comparison).|geometric mean fold rise|1.0|||||TWO_SIDED|95.0|0.76|1.22|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 2).|Serotype 4: GMFR was calculated using all participants with available data from both the Vax 2 and Vax 3 blood draws.||1.22|0.76|
72328400|NCT00500357|144181492|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 95 %confidence interval for the back-transformed GMFR was \> 0.5 (2-fold criterion as a basis for comparison).|geometric mean fold rise|0.7|||||TWO_SIDED|95.0|0.57|0.8|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 2).|Serotype 5: GMFR was calculated using all participants with available data from both the Vax 2 and Vax 3 blood draws.||0.80|0.57|
72328401|NCT00500357|144181492|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 95 %confidence interval for the back-transformed GMFR was \> 0.5 (2-fold criterion as a basis for comparison).|geometric mean fold rise|2.0|||||TWO_SIDED|95.0|1.39|2.84|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 2).|Serotype 6A: GMFR was calculated using all participants with available data from both the Vax 2 and Vax 3 blood draws.||2.84|1.39|
72328402|NCT00500357|144181492|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 95 %confidence interval for the back-transformed GMFR was \> 0.5 (2-fold criterion as a basis for comparison).|geometric mean fold rise|1.3|||||TWO_SIDED|95.0|1.11|1.63|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 2).|Serotype 6B: GMFR was calculated using all participants with available data from both the Vax 2 and Vax 3 blood draws.||1.63|1.11|
72328403|NCT00500357|144181492|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 95 %confidence interval for the back-transformed GMFR was \> 0.5 (2-fold criterion as a basis for comparison).|geometric mean fold rise|0.3|||||TWO_SIDED|95.0|0.18|0.41|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 2).|Serotype 7F: GMFR was calculated using all participants with available data from both the Vax 2 and Vax 3 blood draws.||0.41|0.18|
72328404|NCT00500357|144181492|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 95 %confidence interval for the back-transformed GMFR was \> 0.5 (2-fold criterion as a basis for comparison).|geometric mean fold rise|0.4|||||TWO_SIDED|95.0|0.27|0.68|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 2).|Serotype 9V: GMFR was calculated using all participants with available data from both the Vax 2 and Vax 3 blood draws.||0.68|0.27|
72420540|NCT00279201|144352649|SUPERIORITY_OR_OTHER|||||||0.693||95.0||||P-value is for 3 AM blood glucose.|ANCOVA|Response = Treatment + Baseline + Country + TZD use + sulfo use.||||||0.693
72420541|NCT00279201|144352649|SUPERIORITY_OR_OTHER|||||||0.021||95.0||||P-value is for Baseline AM 2-hour BG excursion.|ANOVA|ANOVA with treatment, country, TZD use, and sulfo use in model.||||||0.021
72420542|NCT00279201|144352649|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for AM 2-hour blood glucose excursion.|ANCOVA|Response = Treatment + Baseline + Country + TZD use + sulfo use.||||||<0.001
72328405|NCT00500357|144181492|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 95 %confidence interval for the back-transformed GMFR was \> 0.5 (2-fold criterion as a basis for comparison).|geometric mean fold rise|0.7|||||TWO_SIDED|95.0|0.57|0.83|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 2).|Serotype 14: GMFR was calculated using all participants with available data from both the Vax 2 and Vax 3 blood draws.||0.83|0.57|
72328406|NCT00500357|144181492|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 95 %confidence interval for the back-transformed GMFR was \> 0.5 (2-fold criterion as a basis for comparison).|geometric mean fold rise|0.8|||||TWO_SIDED|95.0|0.66|1.03|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 2).|Serotype 18C: GMFR was calculated using all participants with available data from both the Vax 2 and Vax 3 blood draws.||1.03|0.66|
72328407|NCT00500357|144181492|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 95 %confidence interval for the back-transformed GMFR was \> 0.5 (2-fold criterion as a basis for comparison).|geometric mean fold rise|0.7|||||TWO_SIDED|95.0|0.58|0.78|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 2).|Serotype 19A: GMFR was calculated using all participants with available data from both the Vax 2 and Vax 3 blood draws.||0.78|0.58|
72328408|NCT00500357|144181492|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 95 %confidence interval for the back-transformed GMFR was \> 0.5 (2-fold criterion as a basis for comparison).|geometric mean fold rise|0.6|||||TWO_SIDED|95.0|0.47|0.73|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 2).|Serotype 19F: GMFR was calculated using all participants with available data from both the Vax 2 and Vax 3 blood draws.||0.73|0.47|
72328409|NCT00500357|144181492|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 95 %confidence interval for the back-transformed GMFR was \> 0.5 (2-fold criterion as a basis for comparison).|geometric mean fold rise|1.5|||||TWO_SIDED|95.0|1.18|1.94|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 2).|Serotype 23F: GMFR was calculated using all participants with available data from both the Vax 2 and Vax 3 blood draws.||1.94|1.18|
72328410|NCT00500357|144181493|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.65|||||TWO_SIDED|95.0|0.52|0.82|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of concentrations (Vax 3 - Vax 1).|Serotype 1: GMFR was calculated using all participants with available data from both the Vax 1 and Vax 3 blood draws.||0.82|0.52|
72328411|NCT00500357|144181493|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.52|||||TWO_SIDED|95.0|0.43|0.62|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of concentrations (Vax 3 - Vax 1).|Serotype 3: GMFR was calculated using all participants with available data from both the Vax 1 and Vax 3 blood draws.||0.62|0.43|
72328412|NCT00500357|144181493|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.63|||||TWO_SIDED|95.0|0.53|0.76|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of concentrations (Vax 3 - Vax 1).|Serotype 4: GMFR was calculated using all participants with available data from both the Vax 1 and Vax 3 blood draws.||0.76|0.53|
72328413|NCT00500357|144181493|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.32|||||TWO_SIDED|95.0|0.27|0.39|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of concentrations (Vax 3 - Vax 1).|Serotype 5: GMFR was calculated using all participants with available data from both the Vax 1 and Vax 3 blood draws.||0.39|0.27|
72328414|NCT00500357|144181493|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.9|||||TWO_SIDED|95.0|0.74|1.1|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of concentrations (Vax 3 - Vax 1).|Serotype 6A: GMFR was calculated using all participants with available data from both the Vax 1 and Vax 3 blood draws.||1.10|0.74|
72328415|NCT00500357|144181493|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.79|||||TWO_SIDED|95.0|0.63|0.99|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of concentrations (Vax 3 - Vax 1).|Serotype 6B: GMFR was calculated using all participants with available data from both the Vax 1 and Vax 3 blood draws.||0.99|0.63|
72328416|NCT00500357|144181493|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.72|||||TWO_SIDED|95.0|0.6|0.87|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of concentrations (Vax 3 - Vax 1).|Serotype 7F: GMFR was calculated using all participants with available data from both the Vax 1 and Vax 3 blood draws.||0.87|0.60|
72328417|NCT00500357|144181493|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.5|||||TWO_SIDED|95.0|0.42|0.6|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of concentrations (Vax 3 - Vax 1).|Serotype 9V: GMFR was calculated using all participants with available data from both the Vax 1 and Vax 3 blood draws.||0.60|0.42|
72420543|NCT00279201|144352649|SUPERIORITY_OR_OTHER|||||||0.567||95.0||||P-value is for Baseline midday 2-hour BG excursion.|ANOVA|ANOVA with treatment, country, TZD use, and sulfo use in model.||||||0.567
72328418|NCT00500357|144181493|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.76|||||TWO_SIDED|95.0|0.59|0.98|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of concentrations (Vax 3 - Vax 1).|Serotype 14: GMFR was calculated using all participants with available data from both the Vax 1 and Vax 3 blood draws.||0.98|0.59|
72328419|NCT00500357|144181493|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.38|||||TWO_SIDED|95.0|0.31|0.46|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of concentrations (Vax 3 - Vax 1).|Serotype 18C: GMFR was calculated using all participants with available data from both the Vax 1 and Vax 3 blood draws.||0.46|0.31|
72420544|NCT00279201|144352649|SUPERIORITY_OR_OTHER|||||||0.005||95.0||||P-value is for Midday 2-hour blood glucose excursion.|ANCOVA|Response = Treatment + Baseline + Country + TZD use + sulfo use.||||||0.005
72420545|NCT00279201|144352649|SUPERIORITY_OR_OTHER|||||||0.994||95.0||||P-value is for Baseline PM 2-hour BG excursion.|ANOVA|ANOVA with treatment, country, TZD use, and sulfo use in model.||||||0.994
72420546|NCT00279201|144352649|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for PM 2-hour blood glucose excursion.|ANCOVA|Response = Treatment + Baseline + Country + TZD use + sulfo use.||||||<0.001
72420547|NCT00279201|144352649|SUPERIORITY_OR_OTHER|||||||0.436||95.0||||P-value is for Baseline mean all meal time excursions.|ANOVA|ANOVA with treatment, country, TZD use, and sulfo use in model.||||||0.436
72420548|NCT00279201|144352649|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Mean of all meal time excursions.|ANCOVA|Response = Treatment + Baseline + Country + TZD use + sulfo use.||||||<0.001
72328420|NCT00500357|144181493|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.6|||||TWO_SIDED|95.0|0.49|0.74|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of concentrations (Vax 3 - Vax 1).|Serotype 19A: GMFR was calculated using all participants with available data from both the Vax 1 and Vax 3 blood draws.||0.74|0.49|
72328421|NCT00500357|144181493|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.64|||||TWO_SIDED|95.0|0.52|0.79|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of concentrations (Vax 3 - Vax 1).|Serotype 19F: GMFR was calculated using all participants with available data from both the Vax 1 and Vax 3 blood draws.||0.79|0.52|
72328422|NCT00500357|144181493|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.76|||||TWO_SIDED|95.0|0.62|0.93|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of concentrations (Vax 3 - Vax 1).|Serotype 23F: GMFR was calculated using all participants with available data from both the Vax 1 and Vax 3 blood draws.||0.93|0.62|
72328423|NCT00500357|144181494|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.68|||||TWO_SIDED|95.0|0.6|0.78|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 2).|Serotype 1: GMFR was calculated using all participants with available data from both the Vax 2 and Vax 3 blood draws.||0.78|0.60|
72328424|NCT00500357|144181494|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.55|||||TWO_SIDED|95.0|0.48|0.64|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 2).|Serotype 3: GMFR was calculated using all participants with available data from both the Vax 2 and Vax 3 blood draws.||0.64|0.48|
72328425|NCT00500357|144181494|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.75|||||TWO_SIDED|95.0|0.65|0.87|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 2).|Serotype 4: GMFR was calculated using all participants with available data from both the Vax 2 and Vax 3 blood draws.||0.87|0.65|
72328426|NCT00500357|144181494|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.68|||||TWO_SIDED|95.0|0.61|0.76|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 2).|Serotype 5: GMFR was calculated using all participants with available data from both the Vax 2 and Vax 3 blood draws.||0.76|0.61|
72328427|NCT00500357|144181494|SUPERIORITY_OR_OTHER||geometric mean fold rise|1.49|||||TWO_SIDED|95.0|1.27|1.75|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 2).|Serotype 6A: GMFR was calculated using all participants with available data from both the Vax 2 and Vax 3 blood draws.||1.75|1.27|
72420549|NCT00279201|144352649|SUPERIORITY_OR_OTHER|||||||0.628||95.0||||P-value is for Baseline mean all 2hour PP BG.|ANOVA|ANOVA with treatment, country, TZD use, and sulfo use in model.||||||0.628
72420550|NCT00279201|144352649|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Mean of all 2-hour postprandial BG.|ANCOVA|Response = Treatment + Baseline + Country + TZD use + sulfo use.||||||<0.001
72328428|NCT00500357|144181494|SUPERIORITY_OR_OTHER||geometric mean fold rise|1.07|||||TWO_SIDED|95.0|0.94|1.21|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 2).|Serotype 6B: GMFR was calculated using all participants with available data from both the Vax 2 and Vax 3 blood draws.||1.21|0.94|
72420551|NCT00279201|144352649|SUPERIORITY_OR_OTHER|||||||0.677||95.0||||P-value is for Baseline AM/PM 2-hour postprandial BG.|ANOVA|ANOVA with treatment, country, TZD use, and sulfo use in model.||||||0.677
72420552|NCT00279201|144352649|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for AM/PM 2-hour postprandial BG.|ANCOVA|Response = Treatment + Baseline + Country + TZD use + sulfo use.||||||<0.001
72420553|NCT00279201|144352649|SUPERIORITY_OR_OTHER|||||||0.364||95.0||||P-value is for Baseline mean all premeal BG.|ANOVA|ANOVA with treatment, country, TZD use, and sulfo use in model.||||||0.364
72420554|NCT00279201|144352649|SUPERIORITY_OR_OTHER|||||||0.055||95.0||||P-value is for Mean of all premeal blood glucose.|ANCOVA|Response = Treatment + Baseline + Country + TZD use + sulfo use.||||||0.055
72420555|NCT00279201|144352649|SUPERIORITY_OR_OTHER|||||||0.165||95.0||||P-value is for Baseline AM/PM 2-hour BG excursion.|ANOVA|ANOVA with treatment, country, TZD use, and sulfo use in model.||||||0.165
72420556|NCT00279201|144352649|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for AM/PM 2-hour blood glucose excursion.|ANCOVA|Response = Treatment + Baseline + Country + TZD use + sulfo use.||||||<0.001
72420557|NCT00279201|144352649|SUPERIORITY_OR_OTHER|||||||0.464||95.0||||P-value is for Baseline mean of all BG values.|ANOVA|ANOVA with treatment, country, TZD use, and sulfo use in model.||||||0.464
72328429|NCT00500357|144181494|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.68|||||TWO_SIDED|95.0|0.58|0.79|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 2).|Serotype 7F: GMFR was calculated using all participants with available data from both the Vax 2 and Vax 3 blood draws.||0.79|0.58|
72328430|NCT00500357|144181494|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.6|||||TWO_SIDED|95.0|0.53|0.68|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 2).|Serotype 9V: GMFR was calculated using all participants with available data from both the Vax 2 and Vax 3 blood draws.||0.68|0.53|
72328431|NCT00500357|144181494|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.59|||||TWO_SIDED|95.0|0.51|0.67|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 2).|Serotype 14: GMFR was calculated using all participants with available data from both the Vax 2 and Vax 3 blood draws.||0.67|0.51|
72328432|NCT00500357|144181494|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.67|||||TWO_SIDED|95.0|0.6|0.74|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 2).|Serotype 18C: GMFR was calculated using all participants with available data from both the Vax 2 and Vax 3 blood draws.||0.74|0.60|
72328433|NCT00500357|144181494|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.78|||||TWO_SIDED|95.0|0.69|0.88|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 2).|Serotype 19A: GMFR was calculated using all participants with available data from both the Vax 2 and Vax 3 blood draws.||0.88|0.69|
72328434|NCT00500357|144181494|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.54|||||TWO_SIDED|95.0|0.47|0.62|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 2).|Serotype 19F: GMFR was calculated using all participants with available data from both the Vax 2 and Vax 3 blood draws.||0.62|0.47|
72328435|NCT00500357|144181494|SUPERIORITY_OR_OTHER||geometric mean fold rise|1.06|||||TWO_SIDED|95.0|0.9|1.25|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 2).|Serotype 23F: GMFR was calculated using all participants with available data from both the Vax 2 and Vax 3 blood draws.||1.25|0.90|
72328436|NCT00161616|144181495|SUPERIORITY_OR_OTHER|||||||0.0541|||||||Fisher Exact|||Comparison of Healed vs Not healed/No outcome for week 13.||||0.0541
72328437|NCT00161616|144181495|SUPERIORITY_OR_OTHER|||||||0.7983|||||||Fisher Exact|||Comparison of Healed vs Not healed/No outcome for week 20.||||0.7983
72328438|NCT00161616|144181496|SUPERIORITY_OR_OTHER|||||||0.8961|||||||Fisher Exact|||||||0.8961
72328439|NCT00861757|144181504|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.8|STANDARD_ERROR_OF_MEAN|0.6||0.003|TWO_SIDED|95.0|-3.0|-0.6|||ANCOVA|||||-0.6|-3.0|0.003
72328440|NCT00861757|144181504|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.7|STANDARD_ERROR_OF_MEAN|0.6||0.004|TWO_SIDED|95.0|-2.9|-0.6|||ANCOVA|||||-0.6|-2.9|0.004
72328441|NCT00861757|144181504|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.5|STANDARD_ERROR_OF_MEAN|0.6|<|0.001|TWO_SIDED|95.0|-3.7|-1.3|||ANCOVA|||||-1.3|-3.7|<0.001
72328442|NCT00861757|144181505|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.4|STANDARD_ERROR_OF_MEAN|0.4|<|0.001|TWO_SIDED|95.0|-2.2|-0.6||This is the p value for the Voiding (Obstructive) Score.|ANCOVA|||||-0.6|-2.2|<0.001
72328443|NCT00861757|144181505|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.1|STANDARD_ERROR_OF_MEAN|0.4||0.005|TWO_SIDED|95.0|-1.9|-0.3||This is the p value for the Voiding (Obstructive) Score.|ANCOVA|||||-0.3|-1.9|0.005
72328444|NCT00861757|144181505|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.9|STANDARD_ERROR_OF_MEAN|0.4|<|0.001|TWO_SIDED|95.0|-2.7|-1.1||This is the p value for the Voiding (Obstructive) Score.|ANCOVA|||||-1.1|-2.7|<0.001
72328445|NCT00861757|144181505|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|0.3||0.072|TWO_SIDED|95.0|-1.0|0.0||This is the p value for the Storage (Irritative) Score.|ANCOVA|||||0.0|-1.0|0.072
72328446|NCT00861757|144181505|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.3||0.021|TWO_SIDED|95.0|-1.1|-0.1||This is the p value for the Storage (Irritative) Score.|ANCOVA|||||-0.1|-1.1|0.021
72328447|NCT00861757|144181505|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.3||0.023|TWO_SIDED|95.0|-1.1|-0.1||This is the p value for the Storage (Irritative) Score.|ANCOVA|||||-0.1|-1.1|0.023
72328448|NCT00861757|144181506|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.1||0.031|TWO_SIDED|95.0|-0.6|0.0|||ANCOVA|||||-0.0|-0.6|0.031
72328449|NCT00861757|144181506|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.1||0.013|TWO_SIDED|95.0|-0.6|-0.1|||ANCOVA|||||-0.1|-0.6|0.013
72328450|NCT00861757|144181506|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.9|-0.4|||ANCOVA|||||-0.4|-0.9|<0.001
72328451|NCT00861757|144181507|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.3||0.201|TWO_SIDED|95.0|-1.0|0.2|||ANCOVA|||||0.2|-1.0|0.201
72328452|NCT00861757|144181507|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.3||0.393|TWO_SIDED|95.0|-0.8|0.3|||ANCOVA|||||0.3|-0.8|0.393
72328453|NCT00861757|144181507|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8|STANDARD_ERROR_OF_MEAN|0.3||0.007|TWO_SIDED|95.0|-1.4|-0.2|||ANCOVA|||||-0.2|-1.4|0.007
72328454|NCT00861757|144181508|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|0.5||0.331|TWO_SIDED|95.0|-1.6|0.5|||ANCOVA|||||0.5|-1.6|0.331
72328455|NCT00861757|144181508|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8|STANDARD_ERROR_OF_MEAN|0.5||0.14|TWO_SIDED|95.0|-1.8|0.3|||ANCOVA|||||0.3|-1.8|0.140
72328456|NCT00861757|144181508|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.5||0.94|TWO_SIDED|95.0|-1.1|1.0|||ANCOVA|||||1.0|-1.1|0.940
72328457|NCT00861757|144181509|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The p-value came from the Cochran-Mantel-Haenszel test to assess if there was any association between treatment (that is, placebo vs 2.5 mg Tadalafil) and 7 categories of the PGI-I.|Cochran-Mantel-Haenszel|||||||<0.001
72328458|NCT00861757|144181509|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The p-value came from the Cochran-Mantel-Haenszel test to assess if there was any association between treatment (that is, placebo vs 5.0 mg Tadalafil) and 7 categories of the PGI-I.|Cochran-Mantel-Haenszel|||||||<0.001
72328459|NCT00861757|144181509|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The p-value came from the Cochran-Mantel-Haenszel test to assess if there was any association between treatment (placebo vs 0.2 mg Tamsulosin) and 7 categories of the PGI-I.|Cochran-Mantel-Haenszel|||||||<0.001
72328460|NCT00861757|144181510|SUPERIORITY_OR_OTHER|||||||0.034||95.0||||The p-value came from the Cochran-Mantel-Haenszel test to assess if there was any association between treatment (that is, placebo vs 2.5 mg Tadalafil) and 7 categories of the CGI-I.|Cochran-Mantel-Haenszel|||||||0.034
72328461|NCT00861757|144181510|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||The p-value came from the Cochran-Mantel-Haenszel test to assess if there was any association between treatment (that is, placebo vs 5.0 mg Tadalafil) and 7 categories of the CGI-I.|Cochran-Mantel-Haenszel|||||||0.002
72328462|NCT00861757|144181510|SUPERIORITY_OR_OTHER|||||||0.001||95.0||||The p-value came from the Cochran-Mantel-Haenszel test to assess if there was any association between treatment (that is, placebo vs 0.2 mg Tamsulosin) and 7 categories of the CGI-I.|Cochran-Mantel-Haenszel|||||||0.001
72328463|NCT00861757|144181511|SUPERIORITY_OR_OTHER|||||||0.412||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.412
72328464|NCT00861757|144181511|SUPERIORITY_OR_OTHER|||||||0.083||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.083
72328465|NCT00861757|144181511|SUPERIORITY_OR_OTHER|||||||0.456||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.456
72328466|NCT00861757|144181512|SUPERIORITY_OR_OTHER|||||||0.688||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.688
72328467|NCT00861757|144181512|SUPERIORITY_OR_OTHER|||||||0.51||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.510
72328468|NCT00861757|144181512|SUPERIORITY_OR_OTHER|||||||0.212||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.212
72328469|NCT00861757|144181513|SUPERIORITY_OR_OTHER|||||||0.005||95.0||||This is the p value for systolic blood pressure.|Wilcoxon (Mann-Whitney)|||||||0.005
72328470|NCT00861757|144181513|SUPERIORITY_OR_OTHER|||||||0.274||95.0||||This is the p value for systolic blood pressure.|Wilcoxon (Mann-Whitney)|||||||0.274
72328471|NCT00861757|144181513|SUPERIORITY_OR_OTHER|||||||0.538||95.0||||This is the p value for systolic blood pressure.|Wilcoxon (Mann-Whitney)|||||||0.538
72328472|NCT00861757|144181513|SUPERIORITY_OR_OTHER|||||||0.008||95.0||||This is the p value for diastolic blood pressure.|Wilcoxon (Mann-Whitney)|||||||0.008
72328473|NCT00861757|144181513|SUPERIORITY_OR_OTHER|||||||0.216||95.0||||This is the p value for diastolic blood pressure.|Wilcoxon (Mann-Whitney)|||||||0.216
72328474|NCT00861757|144181513|SUPERIORITY_OR_OTHER|||||||0.524||95.0||||This is the p value for diastolic blood pressure.|Wilcoxon (Mann-Whitney)|||||||0.524
72328475|NCT00861757|144181514|SUPERIORITY_OR_OTHER|||||||0.007||95.0||||This is the p value for systolic blood pressure.|Wilcoxon rank-sum test|||||||0.007
72328476|NCT00861757|144181514|SUPERIORITY_OR_OTHER|||||||0.723||95.0||||This is the p value for systolic blood pressure.|Wilcoxon rank-sum test|||||||0.723
72328477|NCT00861757|144181514|SUPERIORITY_OR_OTHER|||||||0.273||95.0||||This is the p value for systolic blood pressure.|Wilcoxon rank-sum test|||||||0.273
72328478|NCT00861757|144181514|SUPERIORITY_OR_OTHER|||||||0.005||95.0||||This is the p value for diastolic blood pressure.|Wilcoxon rank-sum test|||||||0.005
72328479|NCT00861757|144181514|SUPERIORITY_OR_OTHER|||||||0.054||95.0||||This is the p value for diastolic blood pressure.|Wilcoxon rank-sum test|||||||0.054
72328480|NCT00861757|144181514|SUPERIORITY_OR_OTHER|||||||0.278||95.0||||This is the p value for diastolic blood pressure.|Wilcoxon rank-sum test|||||||0.278
72328481|NCT00861757|144181515|SUPERIORITY_OR_OTHER|||||||0.33||95.0|||||Wilcoxon rank-sum test|||||||0.330
72328482|NCT00861757|144181515|SUPERIORITY_OR_OTHER|||||||0.838||95.0|||||Wilcoxon rank-sum test|||||||0.838
72328483|NCT00861757|144181515|SUPERIORITY_OR_OTHER|||||||0.409||95.0|||||Wilcoxon rank-sum test|||||||0.409
72328484|NCT03308968|144181516|OTHER||Least square (LS) mean difference|-3.1|STANDARD_ERROR_OF_MEAN|0.36|<|0.0001|TWO_SIDED|95.0|-3.84|-2.42|||ANCOVA|||Analysis was performed using analysis of covariance (ANCOVA) method with treatment, sex, region, special group of treatment failure (yes or no), migraine classification (that is; CM or EM), and treatment-by-migraine classification interaction as fixed effects, and baseline number of migraine days and years since onset of migraines as covariates. The stratification factors (as randomized) were used in the model.||-2.42|-3.84|<0.0001
72328485|NCT03308968|144181516|OTHER||LS mean difference|-3.5|STANDARD_ERROR_OF_MEAN|0.36|<|0.0001|TWO_SIDED|95.0|-4.19|-2.78|||ANCOVA|||Analysis was performed using ANCOVA method with treatment, sex, region, special group of treatment failure (yes or no), migraine classification (that is; CM or EM), and treatment-by-migraine classification interaction as fixed effects, and baseline number of migraine days and years since onset of migraines as covariates. The stratification factors (as randomized) were used in the model.||-2.78|-4.19|<0.0001
72328486|NCT02482298|144181546|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.045|STANDARD_ERROR_OF_MEAN|0.06367|||TWO_SIDED|90.0|-0.061|0.151|||Mixed Models Analysis|||||0.1510|-0.0610|
72328487|NCT02482298|144181546|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0801|STANDARD_ERROR_OF_MEAN|0.06192|||TWO_SIDED|90.0|-0.023|0.1832|||Mixed Models Analysis|||||0.1832|-0.0230|
72328488|NCT02482298|144181548|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1192|STANDARD_ERROR_OF_MEAN|0.05059|||TWO_SIDED|90.0|0.035|0.2035|||Mixed Models Analysis|||||0.2035|0.0350|
72328489|NCT02482298|144181548|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0975|STANDARD_ERROR_OF_MEAN|0.04923|||TWO_SIDED|90.0|0.0155|0.1795|||Mixed Models Analysis|||||0.1795|0.0155|
72328490|NCT01709110|144181586|SUPERIORITY||Odds Ratio (OR)|0.4071||||9.4e-05|TWO_SIDED|95.0|0.256|0.647|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test was adjusted for the antecedent of recent clinical vertebral fractures and recent bisphosphonate use.||||0.647|0.256|0.000094
72328491|NCT01709110|144181586|SUPERIORITY||Risk Ratio (RR)|0.4431||||9.4e-05|TWO_SIDED|95.0|0.29|0.677|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test was adjusted for the antecedent of recent clinical vertebral fractures and recent bisphosphonate use.||||0.677|0.290|0.000094
72328492|NCT01709110|144181587|SUPERIORITY||Odds Ratio (OR)|0.4187||||7.5e-05|TWO_SIDED|95.0|0.269|0.652|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel was adjusted for the antecedent of recent clinical vertebral fractures and recent bisphosphonate use.||||0.652|0.269|0.000075
72328493|NCT01709110|144181587|SUPERIORITY||Risk Ratio (RR)|0.4561||||7.5e-05|TWO_SIDED|95.0|0.305|0.682|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel was adjusted for the antecedent of recent clinical vertebral fractures and recent bisphosphonate use.||||0.682|0.305|0.000075
72328494|NCT01709110|144181588|SUPERIORITY||Stratified Hazard Ratio (HR)|0.4831||||0.000869|TWO_SIDED|95.0|0.316|0.739|||Stratified Log Rank|Stratified Log Rank test was adjusted for the antecedent of recent clinical vertebral fractures and recent bisphosphonate use.|The Stratified Hazard Ratio estimate and corresponding 95% CI were obtained from the number of observed and expected events as part of the stratified log-rank test calculations.|||0.739|0.316|0.000869
72328495|NCT01709110|144181589|SUPERIORITY||Stratified Hazard Ratio (HR)|0.6553||||0.099023|TWO_SIDED|95.0|0.39|1.101|||Stratified Log Rank|Stratified Log Rank test was adjusted for the antecedent of recent clinical vertebral fractures and recent bisphosphonate use.|The Stratified Hazard Ratio estimate and corresponding 95% CI were obtained from the number of observed and expected events as part of the stratified log-rank test calculations.|||1.101|0.390|0.099023
72328496|NCT01709110|144181590|SUPERIORITY||Stratified Hazard Ratio (HR)|0.5786||||0.062432|TWO_SIDED|95.0|0.318|1.052|||Stratified Log Rank|Stratified Log Rank test was adjusted for the antecedent of recent clinical vertebral fractures and recent bisphosphonate use.|The Stratified Hazard Ratio estimate and corresponding 95% CI were obtained from the number of observed and expected events as part of the stratified log-rank test calculations.|||1.052|0.318|0.062432
72328497|NCT01709110|144181591|SUPERIORITY||Odds Ratio (OR)|0.3812|||<|0.001|TWO_SIDED|95.0|0.237|0.614|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test was adjusted for the antecedent of recent clinical vertebral fractures and recent bisphosphonate use.||||0.614|0.237|<0.001
72328498|NCT01709110|144181591|SUPERIORITY||Risk Ratio (RR)|0.4173|||<|0.001|TWO_SIDED|95.0|0.27|0.646|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test was adjusted for the antecedent of recent clinical vertebral fractures and recent bisphosphonate use.||||0.646|0.270|<0.001
72328499|NCT01709110|144181592|SUPERIORITY||Odds Ratio (OR)|0.1593||||0.007|TWO_SIDED|95.0|0.035|0.728|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test was adjusted for the antecedent of recent clinical vertebral fractures and recent bisphosphonate use.||||0.728|0.035|0.007
72328500|NCT01709110|144181592|SUPERIORITY||Risk Ratio (RR)|0.1643||||0.007|TWO_SIDED|95.0|0.036|0.744|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test was adjusted for the antecedent of recent clinical vertebral fractures and recent bisphosphonate use.||||0.744|0.036|0.007
72328501|NCT01709110|144181593|SUPERIORITY||Stratified Hazard Ratio (HR)|0.696||||0.078|TWO_SIDED|95.0|0.461|1.05|||Stratified Log Rank|Stratified Log Rank test was adjusted for the antecedent of recent clinical vertebral fractures and recent bisphosphonate use.|The Stratified Hazard Ratio estimates and corresponding 95% CI were obtained from the number of observed and expected events as part of the stratified log-rank test calculations.|||1.050|0.461|0.078
72328502|NCT01709110|144181594|SUPERIORITY||Least Squares Mean|-0.13|STANDARD_ERROR_OF_MEAN|0.08||0.093|TWO_SIDED|95.0|-0.28|0.02||Model included the following fixed effects: treatment, visit, treatment-by-visit interaction, antecedent of recent clinical vertebral fractures, recent use of bisphosphonate and baseline body height(cm).|Mixed Models Analysis|An unstructured covariance matrix was assumed to account for the correlation between observations of the same participant.|Treatment difference was calculated as Teriparatide - Risedronate.|||0.02|-0.28|0.093
72328503|NCT01709110|144181595|SUPERIORITY||Least Squares Mean|-0.09|STANDARD_ERROR_OF_MEAN|0.17||0.585|TWO_SIDED|95.0|-0.42|0.24||Model included the following fixed effects: treatment, visit, treatment-by-visit interaction, antecedent of recent clinical vertebral fractures, recent use of bisphosphonate and baseline back pain (no pain - worst pain \[0-10\]).|Mixed Models Analysis|An unstructured covariance matrix was assumed to account for the correlation between observations of the same participant.|Treatment difference was calculated as Teriparatide - Risedronate.|||0.24|-0.42|0.585
72328504|NCT01709110|144181596|SUPERIORITY||Least Squares Mean|0.0|STANDARD_ERROR_OF_MEAN|0.01||0.757|TWO_SIDED|95.0|-0.03|0.02||Model included the following fixed effects: treatment, visit, treatment-by-visit interaction, antecedent of recent clinical vertebral fractures, recent use of bisphosphonate baseline EQ-5D-5L (UK).|Mixed Models Analysis|An unstructured covariance matrix was assumed to account for the correlation between observations of the same participant.|Treatment difference was calculated as Teriparatide - Risedronate.|||0.02|-0.03|0.757
72328505|NCT01709110|144181597|SUPERIORITY||Least Squares Mean|0.0|STANDARD_ERROR_OF_MEAN|0.01||0.694|TWO_SIDED|95.0|-0.02|0.01||Model included the following fixed effects: treatment, visit, treatment-by-visit interaction, antecedent of recent clinical vertebral fractures, recent use of bisphosphonate baseline EQ-5D-5L (US).|Mixed Models Analysis|An unstructured covariance matrix was assumed to account for the correlation between observations of the same participant.|Treatment difference was calculated as Teriparatide - Risedronate.|||0.01|-0.02|0.694
72328506|NCT03332173|144181598|SUPERIORITY||||||<|0.0001||||||P value was based on the exact binomial test against the null hypothesis H0: MRR = 0.30 at a significance level of 0.025 (1-sided)|Exact binomial test|||Zanubrutinib versus historical control estimate of 30%||||<0.0001
72328507|NCT00910910|144181613|SUPERIORITY||Hazard Ratio (HR)|1.21||||0.323|TWO_SIDED|90.0|0.88|1.66|||stratified log rank||Based on stratified Cox proportional hazards model comparing the hazard functions associated with treatment groups.|Stratification factors: Disease stage (Binet A or Binet B or Rai I or Rai II versus (VS) Binet C or Rai III or Rai IV); Presence of at least one of the co-morbidities Asparate transaminase (AST)/Alanine transaminase (ALT) ≥ 3.0 times Upper Limits of Normal (ULN,) Creatinine clearance ≥ 30 to \< 60 mL/min, Yes VS No); Presence of at least one 11q deletion, 17p deletion, unmutated Immunoglobulin Heavy-chain Variable-region (IgVH) or Beta-2 Microglobulin (ß2M )\> 4.0 mg/L (Yes versus No VS Unknown)||1.66|0.88|0.323
72328508|NCT00910910|144181614|SUPERIORITY||Cox Proportional Hazard|0.99||||0.967|TWO_SIDED|90.0|0.76|1.29||The p-value is based on a stratified log-rank test|Log Rank||Based on stratified Cox proportional hazards model comparing the hazard functions associated with treatment groups.|Stratification factors: Disease stage (Binet A or Binet B or Rai I or Rai II versus (VS) Binet C or Rai III or Rai IV); Presence of at least one of the co-morbidities Asparate transaminase (AST)/Alanine transaminase (ALT) ≥ 3.0 times Upper Limits of Normal (ULN,) Creatinine clearance ≥ 30 to \< 60 mL/min, Yes VS No); Presence of at least one 11q deletion, 17p deletion, unmutated Immunoglobulin Heavy-chain Variable-region (IgVH) or Beta-2 Microglobulin (ß2M )\> 4.0 mg/L (Yes versus No VS Unknown)||1.29|0.76|0.967
72328509|NCT00910910|144181617|SUPERIORITY||Odds Ratio (OR)|0.65||||0.032|TWO_SIDED|95.0|0.44|0.96|||Fisher Exact|||||0.96|0.44|0.032
72328510|NCT00910910|144181618|SUPERIORITY||Odds Ratio (OR)|0.66||||0.047|TWO_SIDED|95.0|0.45|0.98|||Fisher Exact|||||0.98|0.45|0.047
72328511|NCT00910910|144181619|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.94||||0.826|TWO_SIDED|90.0|0.58|1.52|||Log Rank||Based on stratified Cox proportional hazards model comparing the hazard functions associated with treatment groups|||1.52|0.58|0.826
72328512|NCT00910910|144181620|SUPERIORITY||Cox Proportional Hazard|0.71||||0.149|TWO_SIDED|90.0|0.48|1.05|||Log Rank||Based on stratified Cox proportional hazards model comparing the hazard functions associated with treatment groups.|||1.05|0.48|0.149
72328513|NCT00910910|144181623|SUPERIORITY||Cox Proportional Hazard|1.03||||0.883|TWO_SIDED|90.0|0.73|1.46|||Log Rank||Based on stratified Cox proportional hazards model comparing the hazard functions associated with treatment groups.|||1.46|0.73|0.883
72328514|NCT00910910|144181624|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.06||||0.709|TWO_SIDED|90.0|0.83|1.34|||stratified log rank||Based on stratified Cox proportional hazards model comparing the hazard functions associated with treatment groups|||1.34|0.83|0.709
72328515|NCT03024112|144181636|OTHER|||||||0.68|||||||t-test, 1 sided|||||||0.680
72328516|NCT03703232|144181640|SUPERIORITY|||||||0.092|||||||Wilcoxon signed-rank test|||||||0.092
72328517|NCT03703232|144181641|SUPERIORITY|||||||0.76|||||||Wilcoxon signed-rank test|||||||0.760
72328518|NCT03703232|144181642|SUPERIORITY|||||||0.007|||||||Wilcoxon signed-rank test|||||||0.007
72328519|NCT03703232|144181643|SUPERIORITY|||||||0.003|||||||Wilcoxon signed-rank test|||||||0.003
72328520|NCT03703232|144181644|SUPERIORITY|||||||0.861|||||||Wilcoxon signed-rank test|||||||0.861
72328521|NCT03703232|144181646|SUPERIORITY|||||||0.405|||||||Wilcoxon signed-rank test|||||||0.405
72328522|NCT03703232|144181647|SUPERIORITY|||||||0.798|||||||Wilcoxon signed-rank test|||||||0.798
72328523|NCT03703232|144181648|SUPERIORITY|||||||0.382|||||||Wilcoxon signed-rank test|||||||0.382
72328524|NCT03703232|144181649|SUPERIORITY|||||||0.179|||||||Wilcoxon signed-rank test|||||||0.179
72328525|NCT03703232|144181650|SUPERIORITY|||||||0.984|||||||Wilcoxon signed-rank test|||||||0.984
72328526|NCT03726658|144181664|EQUIVALENCE|Change from baseline in treated group compared to change from baseline in placebo group on Day 2 (Day 1 post initial dose). Statistical tests were 2-sided hypothesis tests performed at the 5% level of significance.|Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|2.24||0.98|TWO_SIDED|||||The a priori threshold for statistical significance was P\<0.05.|Mixed Models Analysis|||Change from baseline in treated group compared to change from baseline in placebo group on Day 2 (Day 1 post initial dose). Since this was a phase 1 study no power calculation was performed.||||0.98
72328527|NCT03726658|144181664|EQUIVALENCE|Change from baseline in treated group compared to change from baseline in placebo group on Day 2 (Day 1 post initial dose). Statistical tests were 2-sided hypothesis tests performed at the 5% level of significance.|Median Difference (Final Values)|2.6|STANDARD_ERROR_OF_MEAN|2.25||0.25|TWO_SIDED|||||The a priori threshold for statistical significance was P\<0.05.|Mixed Models Analysis|Change from baseline in treated group compared to change from baseline in placebo group on Day 2 (Day 1 post initial dose).||Change from baseline in treated group compared to change from baseline in placebo group on Day 2 (Day 1 post initial dose). Since this was a phase 1 study no power calculation was performed.||||0.25
72328528|NCT03726658|144181664|EQUIVALENCE|Change from baseline in treated group compared to change from baseline in placebo group on Day 2 (Day 1 post initial dose).|Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|2.26||0.93|TWO_SIDED|||||Change from baseline in treated group compared to change from baseline in placebo group on Day 2 (Day 1 post initial dose).|Mixed Models Analysis|||Change from baseline in treated group compared to change from baseline in placebo group on Day 2 (Day 1 post initial dose).||||0.93
72328529|NCT03726658|144181665|EQUIVALENCE|Change from baseline in treated group compared to change from baseline in placebo group|Mean Difference (Final Values)|-1.6|STANDARD_ERROR_OF_MEAN|2.02||0.43|TWO_SIDED|||||a priori threshold for statistical significance was \<0.05|Mixed Models Analysis|||Chane from baseline in treated group compared to change from baseline in placebo group. Since this was a phase 1 study no power calculation was performed. Statistical tests were 2-sided hypothesis tests performed at the 5% level of significance.||||0.43
72328530|NCT03726658|144181665|EQUIVALENCE|Change from baseline in treated group compared to change in baseline in placebo group|Median Difference (Final Values)|0.4|STANDARD_ERROR_OF_MEAN|2.02||0.84|TWO_SIDED|||||The a priori threshold for statistical significance was P \<0.05|Mixed Models Analysis|||Change from baseline in treated group compared to change in placebo group. Since this was a phase 1 study no power calculation was performed. Statistical tests were 2-sided hypothesis tests performed at the 5% level of significance.||||0.84
72328531|NCT03726658|144181666|EQUIVALENCE|Change from baseline in treated group compared to change from baseline in placebo group on Day 9|Mean Difference (Final Values)|-1.1|STANDARD_ERROR_OF_MEAN|2.65||0.69|TWO_SIDED|||||A priori threshold for statistical significance was P\<0.05.|Mixed Models Analysis|||Change in MADRS score in treated groups compared to placebo group on Day 9. Since this was a phase 1 study no power calculation was performed. Statistical tests were 2-sided hypothesis tests performed at the 5% level of significance.||||0.69
72328532|NCT03726658|144181666|EQUIVALENCE|Change in MADRS score in treated groups compared to placebo group on Day 9|Mean Difference (Final Values)|-2.1|STANDARD_ERROR_OF_MEAN|2.66||0.44|TWO_SIDED|||||The a priori threshold for statistical significance was P\<0.05|Mixed Models Analysis|||Change in MADRS score in treated groups compared to placebo group on Day 9. Since this was a phase 1 study no power calculation was performed. Statistical tests were 2-sided hypothesis tests performed at the 5% level of significance.||||0.44
72328533|NCT03726658|144181666|EQUIVALENCE|Change in MADRS score in treated groups compared to placebo group on Day 9|Mean Difference (Final Values)|2.1|STANDARD_ERROR_OF_MEAN|2.66||0.43|TWO_SIDED|||||The a priori threshold for statistical significance was P\<0.05|Mixed Models Analysis|||Change in MADRS score in treated groups compared to placebo group on Day 9. Since this was a phase 1 study no power calculation was performed. Statistical tests were 2-sided hypothesis tests performed at the 5% level of significance.||||0.43
72420558|NCT00279201|144352649|SUPERIORITY_OR_OTHER|||||||0.305||95.0||||P-value is for Mean of all blood glucose values.|ANCOVA|Response = Treatment + Baseline + Country + TZD use + sulfo use.||||||0.305
72420559|NCT00279201|144352650|SUPERIORITY_OR_OTHER|||||||0.003||95.0|||||ANCOVA|ANCOVA model with treatment, baseline, country, TZD use, and sulfo use.||||||0.003
72420560|NCT00279201|144352651|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for change from baseline at Week 6.|ANCOVA|Model: Response = Treatment + Baseline + Country + TZD use + sulfonylurea use.||||||<0.001
72420561|NCT00279201|144352651|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for change from baseline at Week 12.|ANCOVA|Model: Response = Treatment + Baseline + Country + TZD use + sulfonylurea use.||||||<0.001
72420562|NCT00279201|144352651|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for change from baseline at Week 18|ANCOVA|Model: Response = Treatment + Baseline + Country + TZD use + sulfonylurea use.||||||<0.001
72328534|NCT03726658|144181666|EQUIVALENCE|Change in MADRS score in treated groups compared to placebo group on Day 15|Median Difference (Final Values)|-1.1|STANDARD_ERROR_OF_MEAN|2.65||0.55|TWO_SIDED|||||The a priori threshold for statistical significance was P\<0.05.|Mixed Models Analysis|||Change in MADRS score in treated groups compared to placebo group on Day 15. Since this was a phase 1 study no power calculaton was performed. Statistical tests were 2-sided hypothesis tests performed at the 5% level of significance.||||0.55
72420563|NCT00279201|144352651|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for change from baseline at Week 24.|ANCOVA|Model: Response = Treatment + Baseline + Country + TZD use + sulfonylurea use.||||||<0.001
72420564|NCT00279201|144352651|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for change from baseline at endpoint.|ANCOVA|Model: Response = Treatment + Baseline + Country + TZD use + sulfonylurea use.||||||<0.001
72420565|NCT00279201|144352652|SUPERIORITY_OR_OTHER|||||||0.497||95.0||||P-value for Actual weight at baseline.|ANOVA|ANOVA with treatment, country, TZD use, and sulfo use in model.||||||0.497
72420566|NCT00279201|144352652|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Actual weight at Week 6.|ANCOVA|Response = Treatment + Baseline + Country + TZD use + sulfo use.||||||<0.001
72328535|NCT03726658|144181666|EQUIVALENCE|Change in MADRS score in treated groups compared to placebo group on Day 15.|Mean Difference (Final Values)|-2.1|STANDARD_ERROR_OF_MEAN|2.66||0.44|TWO_SIDED|||||The a priori threshold for statistical significance was P\<0.05|Mixed Models Analysis|||Change in MADRS score in treated groups compared to placebo group on Day 15. Since this was a phase 1 study no power calculation was performed. Statistical tests were 2-sided hypothesis tests performed at the 5% level of significance.||||0.44
72328536|NCT03726658|144181666|EQUIVALENCE|Change in MADRS score in treated groups compared to placebo group on Day 15|Median Difference (Final Values)|-1.6|STANDARD_ERROR_OF_MEAN|2.69||0.56|TWO_SIDED|||||The a priori threshold for statistical significance was P\<0.05|Mixed Models Analysis|||Change in MADRS score in treated groups compared to placebo group on Day 15. Since this was a phase 1 study no power calculation was performed. Statistical tests were 2-sided hypothesis tests performed at the 5% level of significance.||||0.56
72328537|NCT03726658|144181666|EQUIVALENCE|Change in MADRS score in treated groups compared to placebo group on Day 22.|Mean Difference (Final Values)|0.7|STANDARD_ERROR_OF_MEAN|2.74||0.8|TWO_SIDED|||||The a priori threshold for statistical significance was P\<0.05.|Mixed Models Analysis|||Change in MADRS score in treated groups compared to placebo group on Day 22. Since this was a phase 1 study no power calculation was performed. Statistical tests were 2-sided hypothesis tests performed at the 5% level of significance.||||0.80
72328538|NCT03726658|144181666|EQUIVALENCE|Change in MADRS score in treated groups compared to placebo group on Day 22.|Median Difference (Final Values)|-2.1|STANDARD_ERROR_OF_MEAN|2.74||0.45|TWO_SIDED|||||The a priori threshold for statistical significance was P\<0.05|Mixed Models Analysis|||Change in MADRS score in treated groups compared to placebo group on Day 22. Since this was a phase 1 study no power calculation was performed. Statistical tests were 2-sided hypothesis tests performed at the 5% level of significance.||||0.45
72328539|NCT03726658|144181666|EQUIVALENCE|Change in MADRS score in treated groups compared to placebo group on Day 22.|Mean Difference (Final Values)|-1.2|STANDARD_ERROR_OF_MEAN|2.77||0.67|TWO_SIDED|||||The a priori threshold for statistical significance was P\<0.05|Mixed Models Analysis|||Change in MADRS score in treated groups compared to placebo group on Day 22. Since this was a phase 1 study no power calculation was performed. Statistical tests were 2-sided hypothesis tests performed at the 5% level of significance.||||0.67
72328540|NCT03726658|144181667|EQUIVALENCE|Change from baseline in treated group compared to change from baseline in placebo group on Day 11|Mean Difference (Final Values)|-1.9|STANDARD_ERROR_OF_MEAN|2.36||0.43|TWO_SIDED|||||a priori threshold for statistical significance was p\>0.05|Mixed Models Analysis|||Change from baseline in treated group compared to change from baseline in placebo group on Day 11. Since this was a phase 1 study, no power calculation was performed. Statistical tests were 2-sided hypothesis tests performed at the 5% level of significance.||||0.43
72328541|NCT03726658|144181667|EQUIVALENCE|Change from baseline in treated group compared to change from baseline in placebo group on Day 11|Mean Difference (Final Values)|-1.3|STANDARD_ERROR_OF_MEAN|2.38||0.59|TWO_SIDED|||||The a priori threshold for statistical significance was P\<0.05|Mixed Models Analysis|||Change from baseline in treated group compared to change from baseline in placebo group on Day 11. Since this was a phase 1 study, no power calculation was performed. Statistical tests were 2-sided hypothesis tests performed at the 5% level of significance.||||0.59
72328542|NCT03726658|144181667|EQUIVALENCE|Change from baseline in treated group compared to change from baseline in placebo group on Day 14|Mean Difference (Final Values)|-2.3|STANDARD_ERROR_OF_MEAN|2.44||0.35|TWO_SIDED|||||The a priori threshold for statistical significance was P\<0.05|Mixed Models Analysis|||Change from baseline in treated group compared to change from baseline in placebo group on Day 14, Since this was a phase 1 study no power calculation was performed. Statistical tests were 2-sided hypothesis tests performed at the 5% level of significance.||||0.35
72328543|NCT03726658|144181667|EQUIVALENCE|Change from baseline in treated group compared to change from baseline in placebo group on Day 14|Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|2.48||0.82|TWO_SIDED|||||The a priori threshold for statistical significance was P\<0.05|Mixed Models Analysis|||Change from baseline in treated group compared to change from baseline in placebo group on Day 14. Since this was a phase 1 study, no power calculation was performed. Statistical tests were 2-sided hypothesis tests performed at the 5% level of significance.||||0.82
72328544|NCT03726658|144181667|EQUIVALENCE|Change from baseline in treated group compared to change from baseline in placebo group on Day 18|Mean Difference (Final Values)|-1.4|STANDARD_ERROR_OF_MEAN|2.62||0.61|TWO_SIDED||||||Mixed Models Analysis|||Change from baseline in treated group compared to change from baseline in placebo group on Day 18. Since this was a phase 1 study, no power calculation was performed. Statistical tests were 2-sided hypothesis tests performed at the 5% level of significance.||||0.61
72420567|NCT00279201|144352652|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Actual weight at Week 12.|ANCOVA|Response = Treatment + Baseline + Country + TZD use + Sulfo use.||||||<0.001
72420568|NCT00279201|144352652|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Actual weight at Week 18.|ANCOVA|Response = Treatment + Baseline + Country + TZD use + Sulfo use.||||||<0.001
72420569|NCT00279201|144352652|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Actual weight at Week 24.|ANCOVA|Response = Treatment + Baseline + Country + TZD use + Sulfo use.||||||<0.001
72420570|NCT00279201|144352652|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||P-value is for Actual weight at Endpoint.|ANCOVA|Response = Treatment + Baseline + Country + TZD use + Sulfo use.||||||<0.0001
72420571|NCT00279201|144352653|SUPERIORITY_OR_OTHER|||||||0.016||95.0||||P-value is for Hypoglycemic episodes endpoint.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel statistic controlling for country, TZD use, and sulfo use.||||||0.016
72420572|NCT00279201|144352653|SUPERIORITY_OR_OTHER|||||||0.037||95.0||||P-value is for Overall hypoglycemic episodes.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel statistic controlling for country, TZD use, and sulfo use.||||||0.037
72420573|NCT00279201|144352653|SUPERIORITY_OR_OTHER|||||||0.834||95.0||||P-value is for Nocturnal hypoglycemic episodes endpoint.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel statistic controlling for country, TZD use, and sulfo use.||||||0.834
72420574|NCT00279201|144352653|SUPERIORITY_OR_OTHER|||||||0.585||95.0||||P-value is for Nocturnal hypoglycemic episodes overall.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel statistic controlling for country, TZD use, and sulfo use.||||||0.585
72328545|NCT03726658|144181667|EQUIVALENCE|Change from baseline in treated group compared to change from baseline in placebo group on Day 18|Median Difference (Final Values)|2.0|STANDARD_ERROR_OF_MEAN|2.69||0.47|TWO_SIDED|||||The a priori threshold for statistical significance was P\<0.05|Mixed Models Analysis|||Change from baseline in treated group compared to change from baseline in placebo group on Day 18. Since this was a phase 1 study no power calculation was performed. Statistical tests were 2-sided hypothesis tests performed at the 5% level of significance.||||0.47
72420575|NCT00279201|144352653|SUPERIORITY_OR_OTHER|||||||0.241||95.0||||P-value is for Severe hypoglycemic episodes endpoint.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel statistic controlling for country, TZD use, and sulfo use.||||||0.241
72328546|NCT03726658|144181667|EQUIVALENCE|Change from baseline in treated group compared to change from baseline in placebo group on Day 21|Mean Difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|2.48||0.76|TWO_SIDED||||||Mixed Models Analysis|||Change from baseline in treated group compared to change from baseline in placebo group on Day 21. Since this was a phase 1 study, no power calculation was performed. Statistical tests were 2-sided hypothesis tests performed at the 5% level of significance.||||0.76
72328547|NCT03726658|144181667|EQUIVALENCE|Change from baseline in treated group compared to change from baseline in placebo group on Day 21|Median Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|2.51||0.99|TWO_SIDED|||||Change from baseline in treated group compared to change from baseline in placebo group on Day 21|Mixed Models Analysis|||Change from baseline in treated group compared to change from baseline in placebo group on Day 21. Since this was a phase 1 study no power calculation was performed. Statistical tests were 2-sided hypothesis tests performed at the 5% level of significance.||||0.99
72328548|NCT00090779|144181668|SUPERIORITY_OR_OTHER|||||||0.005||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.005
72328549|NCT00090779|144181669|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.002
72328550|NCT00997984|144181748|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||A hierarchical testing structure was employed. First placebo vs all-active, then placebo vs am and lastly placebo vs pm. Testing was stopped when one comparison was not significant (p\<0.05).|ANCOVA|||Study designed to detect an effect size of 0.4 with 90% at the 0.05 significance level.||||<0.001
72328551|NCT00997984|144181748|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||A hierarchical testing structure was employed. First placebo vs all-active, then placebo vs am and lastly placebo vs pm. Testing was stopped when one comparison was not significant (p\<0.05).|ANCOVA|||Study designed to detect an effect size of 0.4 with 90% at the 0.05 significance level.||||<0.001
72328552|NCT00997984|144181748|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||A hierarchical testing structure was employed. First placebo vs all-active, then placebo vs am and lastly placebo vs pm. Testing was stopped when one comparison was not significant (p\<0.05).|ANCOVA|||Study designed to detect an effect size of 0.4 with 90% at the 0.05 significance level.||||<0.001
72328553|NCT00997984|144181749|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||No formal adjustment for multiplicity was done.|Cochran-Mantel-Haenszel|||||||<0.001
72328554|NCT00997984|144181749|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||No formal adjustment for multiplicity was done.|Cochran-Mantel-Haenszel|||||||<0.001
72328555|NCT00997984|144181749|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||No formal adjustment for multiplicity was done.|Cochran-Mantel-Haenszel|||||||<0.001
72328556|NCT00997984|144181750|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||No formal adjustment for multiplicity was done.|Cochran-Mantel-Haenszel|||||||<0.001
72328557|NCT00997984|144181750|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||No formal adjustment for multiplicity was done.|Cochran-Mantel-Haenszel|||||||<0.001
72328558|NCT00997984|144181750|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||No formal adjustment for multiplicity was done.|Cochran-Mantel-Haenszel|||||||<0.001
72328559|NCT00997984|144181751|SUPERIORITY_OR_OTHER_LEGACY|||||||0.099||95.0||||No formal adjustment for multiplicity was done.|ANCOVA|||||||0.099
72328560|NCT00997984|144181751|SUPERIORITY_OR_OTHER_LEGACY|||||||0.596||95.0||||No formal adjustment for multiplicity was done.|ANCOVA|||||||0.596
72328561|NCT00997984|144181751|SUPERIORITY_OR_OTHER_LEGACY|||||||0.023||95.0||||No formal adjustment for multiplicity was done.|ANCOVA|||||||0.023
72328562|NCT00997984|144181753|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||No formal adjustment for multiplicity was done.|ANCOVA|||||||<0.001
72328563|NCT00997984|144181753|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||No formal adjustment for multiplicity was done.|ANCOVA|||||||<0.001
72328564|NCT00997984|144181753|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||No formal adjustment for multiplicity was done.|ANCOVA|||||||<0.001
72328565|NCT00997984|144181754|SUPERIORITY_OR_OTHER_LEGACY|||||||0.712||95.0||||No formal adjustment for multiplicity was done.|ANCOVA|||||||0.712
72328566|NCT00997984|144181754|SUPERIORITY_OR_OTHER_LEGACY|||||||0.531||95.0||||No formal adjustment for multiplicity was done.|ANCOVA|||||||0.531
72328567|NCT00997984|144181754|SUPERIORITY_OR_OTHER_LEGACY|||||||0.226||95.0||||No formal adjustment for multiplicity was done.|ANCOVA|||||||0.226
72328568|NCT00997984|144181755|SUPERIORITY_OR_OTHER_LEGACY|||||||0.859||95.0||||No formal adjustment for multiplicity was done.|Cochran-Mantel-Haenszel|||||||0.859
72328569|NCT00997984|144181755|SUPERIORITY_OR_OTHER_LEGACY|||||||0.527||95.0||||No formal adjustment for multiplicity was done.|Cochran-Mantel-Haenszel|||||||0.527
72328570|NCT00997984|144181755|SUPERIORITY_OR_OTHER_LEGACY|||||||0.739||95.0||||No formal adjustment for multiplicity was done.|Cochran-Mantel-Haenszel|||||||0.739
72328571|NCT00997984|144181756|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||No formal adjustment for multiplicity was done.|ANCOVA|||||||<0.001
72328572|NCT00997984|144181756|SUPERIORITY_OR_OTHER_LEGACY|||||||0.004||95.0||||No formal adjustment for multiplicity was done.|ANCOVA|||||||0.004
72328573|NCT00997984|144181756|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001||95.0||||No formal adjustment for multiplicity was done.|ANCOVA|||||||0.001
72420576|NCT00279201|144352653|SUPERIORITY_OR_OTHER|||||||0.08||95.0||||P-value is for Severe hypoglycemic episodes overall. Initiation phase and maintenance phase are included.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel statistic controlling for country, TZD use, and sulfo use.||||||0.080
72420577|NCT00279201|144352654|SUPERIORITY_OR_OTHER|||||||0.009||95.0||||P-value is for Nocturnal episodes Endpoint.|ANOVA|Response = Treatment + Country + TZD use + Sulfo use.||||||0.009
72420578|NCT00279201|144352654|SUPERIORITY_OR_OTHER|||||||0.42||95.0||||P-value is for Nocturnal episodes Overall.|ANOVA|Response = Treatment + Country + TZD use + Sulfo use.||||||0.420
72328574|NCT02195700|144181839|SUPERIORITY||LSM difference|-1.4|STANDARD_ERROR_OF_MEAN|0.6||0.0188|TWO_SIDED|95.0|-2.6|-0.2||5% level of significance (2-sided)|unstructured covariance|||The linear mixed model for repeated measurements (MMRM) included fixed effects for treatment, each scheduled time point (5 levels: weeks 2, 4, 6, 9, and 12), the treatment-by-time point interaction, and the DRA status. Baseline AIMS score was a covariate. The unstructured covariance model was used, and the primary analysis compared the SD-809 and placebo groups at week 12. This was based on the F-test using the Satterhwaite method to compute the denominator degrees of freedom.||-0.2|-2.6|0.0188
72420579|NCT00279201|144352654|SUPERIORITY_OR_OTHER|||||||0.165||95.0||||P-value is for Severe episodes Endpoint.|ANOVA|Response = Treatment + Country + TZD use + Sulfo use.||||||0.165
72328575|NCT02195700|144181840|SUPERIORITY||Differences in %|7.9||||0.4001|TWO_SIDED|95.0|-10.2|25.2||5% level of significance (2-sided)|Pearson's chi-square test|||The secondary efficacy endpoints were analyzed using a hierarchical testing procedure. If the primary analysis was statistically significant (p\<0.05), then the first key secondary endpoint was to be analyzed. If the first key secondary endpoint was statistically significant, then the second key secondary endpoint was to be similarly analyzed. For any analysis that was not statistically significant, all subsequent analyses of key secondary endpoints were exploratory rather than confirmatory.||25.2|-10.2|0.4001
72420580|NCT00279201|144352654|SUPERIORITY_OR_OTHER|||||||0.167||95.0||||P-value is for Severe episodes Overall.|ANOVA|Response = Treatment + Country + TZD use + Sulfo use.||||||0.167
72420581|NCT00279201|144352654|SUPERIORITY_OR_OTHER|||||||0.006||95.0||||P-value is for Hypoglycemia episodes Endpoint.|ANOVA|Response = Treatment + Country + TZD use + Sulfo use.||||||0.006
72420582|NCT00279201|144352654|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Hypoglycemia episodes Overall.|ANOVA|Response = Treatment + Country + TZD use + Sulfo use.||||||<0.001
72420583|NCT00279201|144352655|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Week 1.|ANOVA|ANOVA with treatment, country, TZD use, and sulfo use in the model.||||||<0.001
72420584|NCT00279201|144352655|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Week 2.|ANOVA|ANOVA with treatment, country, TZD use, and sulfo use in the model.||||||<0.001
72420585|NCT00279201|144352655|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Week 3.|ANOVA|ANOVA with treatment, country, TZD use, and sulfo use in the model.||||||<0.001
72328576|NCT02931838|144181847|SUPERIORITY|||||||0.4873||||||Nominal p-value|Chi-squared|P-value is from the Fishers Exact if at least one cell count is \<5. Otherwise, p-value is from the Chi-Square test.||||||0.4873
72420586|NCT00279201|144352655|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Week 4.|ANOVA|ANOVA with treatment, country, TZD use, and sulfo use in the model.||||||<0.001
72420587|NCT00279201|144352655|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Week 5.|ANOVA|ANOVA with treatment, country, TZD use, and sulfo use in the model.||||||<0.001
72328577|NCT02931838|144181847|SUPERIORITY|||||||0.0003||||||Nominal p-value|Chi-squared|P-value is from the Fishers Exact if at least one cell count is \<5. Otherwise, p-value is from the Chi-Square test.||||||0.0003
72328578|NCT02931838|144181847|SUPERIORITY||||||<|0.0001||||||Nominal p-value|Chi-squared|P-value is from the Fishers Exact if at least one cell count is \<5. Otherwise, p-value is from the Chi-Square test.||||||<0.0001
72420588|NCT00279201|144352655|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Week 6.|ANOVA|ANOVA with treatment, country, TZD use, and sulfo use in the model.||||||<0.001
72420589|NCT00279201|144352655|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Week 8.|ANOVA|ANOVA with treatment, country, TZD use, and sulfo use in the model.||||||<0.001
72328579|NCT02931838|144181847|SUPERIORITY||||||<|0.0001||||||Nominal p-value|Chi-squared|P-value is from the Fishers Exact if at least one cell count is \<5. Otherwise, p-value is from the Chi-Square test.||||||< 0.0001
72328580|NCT02931838|144181847|SUPERIORITY||||||<|0.0001||||||Nominal p-value|Chi-squared|P-value is from the Fishers Exact if at least one cell count is \<5. Otherwise, p-value is from the Chi-Square test.||||||<0.0001
72328581|NCT03419897|144181973|SUPERIORITY|||||||0.0001|||||||Binomial exact test|||Tislelizumab compared with historical ORR rate of 7%||||0.0001
72328582|NCT03574610|144181990|OTHER||||||<|0.05|||||||Student's t-test|||Strong desire to void: L inferior frontal gyrus||||<0.05
72328583|NCT03574610|144181990|OTHER||||||<|0.05|||||||Student's t-test|||Desire to void: L superior temporal gyrus||||<0.05
72328584|NCT03574610|144181990|OTHER||||||<|0.05|||||||Student's t-test|||Strong desire to void: L inferior temporal gyrus||||<0.05
72328585|NCT03574610|144181990|OTHER||||||<|0.05|||||||Student's t-test|||Strong desire to void: L middle temporal gyrus||||<0.05
72328586|NCT03574610|144181990|OTHER||||||<|0.05|||||||Student's t-test|||Strong desire to void: R middle temporal gyrus||||<0.05
72328587|NCT03574610|144181990|OTHER||||||<|0.05|||||||Student's t-test|||Strong desire to void: L inferior parietal lobule||||<0.05
72328588|NCT03574610|144181990|OTHER||||||<|0.05|||||||Student's t-test|||Strong desire to void: R inferior parietal lobule||||<0.05
72328589|NCT03574610|144181990|OTHER||||||<|0.05|||||||Student's t-test|||Strong desire to void: R paracentral lobule||||<0.05
72328590|NCT03574610|144181990|OTHER||||||<|0.05|||||||Student's t-test|||Strong desire to void: R superior parietal lobule||||<0.05
72328591|NCT03574610|144181990|OTHER||||||<|0.05|||||||Student's t-test|||Strong desire to void: R supplementary motor area||||<0.05
72328592|NCT03574610|144181990|OTHER||||||<|0.05|||||||Student's t-test|||Strong desire to void: L postcentral gyrus||||<0.05
72328593|NCT03574610|144181990|OTHER||||||<|0.05|||||||Student's t-test|||Strong desire to void: R postcentral gyrus||||<0.05
72328594|NCT03574610|144181990|OTHER||||||<|0.05|||||||Student's t-test|||Strong desire to void: L angular gyrus||||<0.05
72328595|NCT03574610|144181990|OTHER||||||<|0.05|||||||Student's t-test|||Strong desire to void: R supramarginal gyrus||||<0.05
72328596|NCT03574610|144181990|OTHER||||||<|0.05|||||||Student's t-test|||Strong desire to void: L superior medial gyrus||||<0.05
72328597|NCT03574610|144181990|OTHER||||||<|0.05|||||||Student's t-test|||Strong desire to void: L inferior occipital gyrus||||<0.05
72420590|NCT00279201|144352655|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Week 10.|ANOVA|ANOVA with treatment, country, TZD use, and sulfo use in the model.||||||<0.001
72420591|NCT00279201|144352655|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Week 12.|ANOVA|ANOVA with treatment, country, TZD use, and sulfo use in the model.||||||<0.001
72420592|NCT00279201|144352655|SUPERIORITY_OR_OTHER|||||||0.001||95.0||||P-value is for Week 18.|ANOVA|ANOVA with treatment, country, TZD use, and sulfo use in the model.||||||0.001
72420593|NCT00279201|144352655|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Week 24.|ANOVA|ANOVA with treatment, country, TZD use, and sulfo use in the model.||||||<0.001
72420594|NCT00279201|144352655|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Endpoint.|ANOVA|ANOVA with treatment, country, TZD use, and sulfo use in the model.||||||<0.001
72420595|NCT00279201|144352656|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA|ANOVA with met goal/did not meet goal, country, TZD use, and sulfo use in model.||||||<0.001
72420596|NCT00279201|144352657|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is overall.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by country, TZD use, and Sulfo use.||||||<0.001
72420597|NCT00279201|144352658|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA|ANOVA with met goal/did not meet goal, country, TZD use, and sulfo use in model.||||||<0.001
72420598|NCT00279201|144352659|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA|ANOVA with met goal/did not meet goal, country, TZD use and Sulfo use in model.||||||<0.001
72420599|NCT00279201|144352660|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is overall.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by country, TZD use, and sulfo use.||||||<0.001
72420600|NCT00279201|144352661|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA|ANOVA with met goal/did not meet goal, country, TZD use, and sulfo use in model.||||||<0.001
72420601|NCT00279201|144352662|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Pre Meals Blood Glucose.|ANOVA|ANOVA with met goal/did not meet goal, country, TZD use, and sulfo use in model.||||||<0.001
72420602|NCT00279201|144352662|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Post Meals Blood Glucose.|ANOVA|ANOVA with met goal/did not meet goal, country, TZD use, and sulfo use in model.||||||<0.001
72420603|NCT00279201|144352662|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Average of All Blood Glucose.|ANOVA|ANOVA with met goal/did not meet goal, country, TZD use, and sulfo use in model.||||||<0.001
72420604|NCT00279201|144352662|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Fasting Blood Glucose.|ANOVA|ANOVA with met goal/did not meet goal, country, TZD use, and sulfo use in model.||||||<0.001
72420605|NCT00279201|144352663|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Sulfonylurea/Metformin.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by country only.||||||<0.001
72420606|NCT00279201|144352663|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for TZD/Metformin.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by country only.||||||<0.001
72420607|NCT00279201|144352663|SUPERIORITY_OR_OTHER|||||||0.969||95.0||||P-value is for Sulfonylurea/TZD.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by country only.||||||0.969
72420608|NCT00279201|144352663|SUPERIORITY_OR_OTHER|||||||0.225||95.0||||P-value is for Patients with 3 drugs (Sulfonylurea/TZD/Metformin).|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by country only.||||||0.225
72420609|NCT00279201|144352664|SUPERIORITY_OR_OTHER|||||||0.204||95.0||||P-value is for Week 0.|ANOVA|ANCOVA used with treatment, country, TZD use, and sulfo use in the model.||||||0.204
72420610|NCT00279201|144352664|SUPERIORITY_OR_OTHER|||||||0.004||95.0||||P-value is for Week 12.|ANCOVA|ANCOVA used with treatment, baseline HbA1c, country, TZD use, and sulfo use in the model.||||||0.004
72420611|NCT00279201|144352664|SUPERIORITY_OR_OTHER|||||||0.657||95.0||||P-value is for Week 24.|ANCOVA|ANCOVA used with treatment, baseline HbA1c, country, TZD use, and sulfo use in the model.||||||0.657
72420612|NCT00279201|144352664|SUPERIORITY_OR_OTHER|||||||0.595||95.0||||P-value is for Week 36.|ANCOVA|ANCOVA used with treatment, baseline HbA1c, country, TZD use, and sulfo use in the model.||||||0.595
72420613|NCT00279201|144352664|SUPERIORITY_OR_OTHER|||||||0.142||95.0||||P-value for Week 48.|ANCOVA|ANCOVA used with treatment, baseline HbA1c, country, TZD use, and sulfo use in the model.||||||0.142
72420614|NCT00279201|144352664|SUPERIORITY_OR_OTHER|||||||0.551||95.0||||P-value for Week 60.|ANCOVA|ANCOVA used with treatment, baseline HbA1c, country, TZD use, and sulfo use in the model.||||||0.551
72420615|NCT00279201|144352664|SUPERIORITY_OR_OTHER|||||||0.779||95.0||||P-value is for Week 72.|ANCOVA|ANCOVA used with treatment, baseline HbA1c, country, TZD use, and sulfo use in the model.||||||0.779
72420616|NCT00279201|144352664|SUPERIORITY_OR_OTHER|||||||0.175||95.0||||P-value is for Week 84.|ANCOVA|ANCOVA used with treatment, baseline HbA1c, country, TZD use, and sulfo use in the model.||||||0.175
72420617|NCT00279201|144352664|SUPERIORITY_OR_OTHER|||||||0.018||95.0||||P-value for Week 96.|ANCOVA|ANCOVA used with treatment, baseline HbA1c, country, TZD use, and sulfo use in the model.||||||0.018
72420618|NCT00279201|144352664|SUPERIORITY_OR_OTHER|||||||0.047||95.0||||P-value is for Week 108.|ANCOVA|ANCOVA used with treatment, baseline HbA1c, country, TZD use, and sulfo use in the model.||||||0.047
72420619|NCT00279201|144352664|SUPERIORITY_OR_OTHER|||||||0.027||95.0||||P-value is for Week 120.|ANCOVA|ANCOVA used with treatment, baseline HbA1c, country, TZD use, and sulfo use in the model.||||||0.027
72420620|NCT00279201|144352664|SUPERIORITY_OR_OTHER|||||||0.017||95.0||||P-value is for Endpoint.|ANCOVA|ANCOVA used with treatment, baseline HbA1c, country, TZD use, and sulfo use in the model.||||||0.017
72420621|NCT00279201|144352665|SUPERIORITY_OR_OTHER|||||||0.218||95.0||||P-value for Baseline mean fasting blood glucose.|ANOVA|ANOVA with treatment, country, TZD use, and sulfo use in model.||||||0.218
72420622|NCT00279201|144352665|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Endpoint mean fasting blood glucose.|ANCOVA|Response = Treatment + Baseline + Country + TZD + Sulfo use.||||||<0.001
72328598|NCT03574610|144181990|OTHER||||||<|0.05|||||||Student's t-test|||Strong desire to void: L middle cingulate cortex||||<0.05
72328599|NCT03574610|144181990|OTHER||||||<|0.05|||||||Student's t-test|||Strong desire to void: R middle cingulate cortex||||<0.05
72328600|NCT03574610|144181990|OTHER||||||<|0.05|||||||Student's t-test|||Strong desire to void: R posterior cingulate cortex||||<0.05
72328601|NCT03574610|144181990|OTHER||||||<|0.05|||||||Student's t-test|||Strong desire to void: L thalamus||||<0.05
72328602|NCT03574610|144181990|OTHER||||||<|0.05|||||||Student's t-test|||Strong desire to void: R thalamus||||<0.05
72328603|NCT03574610|144181990|OTHER||||||<|0.05|||||||Student's t-test|||Strong desire to void: L precuneus||||<0.05
72328604|NCT03574610|144181990|OTHER||||||<|0.05|||||||Student's t-test|||Strong desire to void: R precuneus||||<0.05
72328605|NCT03574610|144181990|OTHER||||||<|0.05|||||||Student's t-test|||Strong desire to void: L caudate nucleus||||<0.05
72328606|NCT03574610|144181990|OTHER||||||<|0.05|||||||Student's t-test|||Strong desire void: L hippocampus||||<0.05
72328607|NCT03574610|144181990|OTHER||||||<|0.05|||||||Student's t-test|||Strong desire to void: L hippocampus||||<0.05
72328608|NCT03574610|144181990|OTHER||||||<|0.05|||||||Student's t-test|||Strong desire to void: L putamen||||<0.05
72328609|NCT03574610|144181990|OTHER||||||<|0.05|||||||Student's t-test|||Strong desire to void: L precentral gyrus||||<0.05
72328610|NCT03574610|144181990|OTHER||||||<|0.05|||||||Student's t-test|||Strong desire to void: R precentral gyrus||||<0.05
72328611|NCT03574610|144181990|OTHER||||||<|0.05|||||||Student's t-test|||Strong desire to void: L insula lobe||||<0.05
72420623|NCT00279201|144352665|SUPERIORITY_OR_OTHER|||||||0.897||95.0||||P-value is for Baseline AM 2-hour (hr) postprandial.|ANOVA|ANOVA with treatment, country, TZD use, and sulfo use in model.||||||0.897
72420624|NCT00279201|144352665|SUPERIORITY_OR_OTHER|||||||0.138||95.0||||P-value is for Endpoint AM 2-hour postprandial.|ANCOVA|Response = Treatment + Baseline + Country + TZD + Sulfo use.||||||0.138
72328612|NCT03574610|144181990|OTHER||||||<|0.05|||||||Student's t-test|||Strong desire to void: L superior frontal gyrus||||<0.05
72328613|NCT03574610|144181990|OTHER||||||<|0.05|||||||Student's t-test|||Strong desire to void: L middle frontal gyrus||||<0.05
72328614|NCT03574610|144181990|OTHER||||||<|0.05|||||||Student's t-test|||Strong desire to void: R cerebellum||||<0.05
72420625|NCT00279201|144352665|SUPERIORITY_OR_OTHER|||||||0.867||95.0||||P-value is for Baseline midday premeal blood glucose.|ANOVA|ANOVA with treatment, country, TZD use, and sulfo use in model.||||||0.867
72328615|NCT03574610|144181990|OTHER||||||<|0.05|||||||Student's t-test|||Strong desire to void: R fusiform gyrus||||<0.05
72328616|NCT03574610|144181990|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: L postcentral gyrus||||<0.05
72328617|NCT03574610|144181990|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: R postcentral gyrus||||<0.05
72328618|NCT03574610|144181990|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: L precentral gyrus||||<0.05
72420626|NCT00279201|144352665|SUPERIORITY_OR_OTHER|||||||0.031||95.0||||P-value is for Endpoint midday premeal blood.|ANCOVA|Response = Treatment + Baseline + Country + TZD + Sulfo use.||||||0.031
72328619|NCT03574610|144181990|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: R precentral gyrus||||<0.05
72328620|NCT03574610|144181990|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: L superior temporal gyrus||||<0.05
72328621|NCT03574610|144181990|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: R superior temporal gyrus||||<0.05
72328622|NCT03574610|144181990|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: L middle temporal gyrus||||<0.05
72328623|NCT03574610|144181990|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: R middle temporal gyrus||||<0.05
72328624|NCT03574610|144181990|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: L inferior temporal gyrus||||<0.05
72328625|NCT03574610|144181990|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: L supramarginal gyrus||||<0.05
72328626|NCT03574610|144181990|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: R supramarginal gyrus||||<0.05
72328627|NCT03574610|144181990|OTHER||||||<|0.05|||||||Student's t-test|||Voiding Initiation: L inferior occipital gyrus||||<0.05
72328628|NCT03574610|144181990|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: R superior occipital gyrus||||<0.05
72328629|NCT03574610|144181990|OTHER||||||<|0.05|||||||Student's t-test|||Voiding Initiation: R middle occipital gyrus||||<0.05
72328630|NCT03574610|144181990|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: L inferior frontal gyrus (p. Orbitalis)||||<0.05
72328631|NCT03574610|144181990|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: L inferior frontal gyrus (p. Triangularis)||||<0.05
72328632|NCT03574610|144181990|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: L inferior frontal gyrus (p. Opercularis)||||<0.05
72328633|NCT03574610|144181990|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: R inferior frontal gyrus (p. Orbitalis)||||<0.05
72328634|NCT03574610|144181990|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: R inferior frontal gyrus (p. Triangularis)||||<0.05
72328635|NCT03574610|144181990|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: L cerebellum||||<0.05
72328636|NCT03574610|144181990|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: L rectal gyrus||||<0.05
72328637|NCT03574610|144181990|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: R rectal gyrus||||<0.05
72328638|NCT03574610|144181990|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: L superior medial gyrus||||<0.05
72328639|NCT03574610|144181990|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: R superior medial gyrus||||<0.05
72328640|NCT03574610|144181990|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: L superior frontal gyrus||||<0.05
72328641|NCT03574610|144181990|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: R superior frontal gyrus||||<0.05
72420627|NCT00279201|144352665|SUPERIORITY_OR_OTHER|||||||0.792||95.0||||P-value is for Baseline midday 2hr postprandial.|ANOVA|ANOVA with treatment, country, TZD use, and sulfo use in model.||||||0.792
72420628|NCT00279201|144352665|SUPERIORITY_OR_OTHER|||||||0.51||95.0||||P-value is for Endpoint midday 2hr postprandial.|ANCOVA|Response = Treatment + Baseline + Country + TZD + Sulfo use.||||||0.510
72420629|NCT00279201|144352665|SUPERIORITY_OR_OTHER|||||||0.535||95.0||||P-value is for Baseline PM pre-meal blood glucose.|ANOVA|ANOVA with treatment, country, TZD use, and sulfo use in model.||||||0.535
72420630|NCT00279201|144352665|SUPERIORITY_OR_OTHER|||||||0.517||95.0||||P-value is for Endpoint PM pre-meal blood glucose.|ANCOVA|Response = Treatment + Baseline + Country + TZD + Sulfo use.||||||0.517
72420631|NCT00279201|144352665|SUPERIORITY_OR_OTHER|||||||0.869||95.0||||P-value is for Baseline PM 2hr postprandial.|ANOVA|ANOVA with treatment, country, TZD use, and sulfo use in model.||||||0.869
72420632|NCT00279201|144352665|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Endpoint PM 2hr postprandial.|ANCOVA|Response = Treatment + Baseline + Country + TZD + Sulfo use.||||||<0.001
72420633|NCT00279201|144352665|SUPERIORITY_OR_OTHER|||||||0.164||95.0||||P-value is for Baseline 3AM blood glucose.|ANOVA|ANOVA with treatment, country, TZD use, and sulfo use in model.||||||0.164
72420634|NCT00279201|144352665|SUPERIORITY_OR_OTHER|||||||0.234||95.0||||P-value is for Endpoint 3AM blood glucose.|ANCOVA|Response = Treatment + Baseline + Country + TZD + Sulfo use.||||||0.234
72420635|NCT00279201|144352665|SUPERIORITY_OR_OTHER|||||||0.175||95.0||||P-value is for Baseline AM 2hr excursion.|ANOVA|ANOVA with treatment, country, TZD use, and sulfo use in model.||||||0.175
72420636|NCT00279201|144352665|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Endpoint AM 2hr excursion.|ANCOVA|Response = Treatment + Baseline + Country + TZD + Sulfo use.||||||<0.001
72420637|NCT00279201|144352665|SUPERIORITY_OR_OTHER|||||||0.589||95.0||||P-value is for Baseline midday 2hr excursion.|ANOVA|ANOVA with treatment, country, TZD use, and sulfo use in model.||||||0.589
72420638|NCT00279201|144352665|SUPERIORITY_OR_OTHER|||||||0.161||95.0||||P-value is for Endpoint midday 2hr excursion.|ANCOVA|Response = Treatment + Baseline + Country + TZD + Sulfo use.||||||0.161
72420639|NCT00279201|144352665|SUPERIORITY_OR_OTHER|||||||0.674||95.0||||P-value is for Baseline PM 2hr excursion.|ANOVA|ANOVA with treatment, country, TZD use, and sulfo use in model.||||||0.674
72420640|NCT00279201|144352665|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Endpoint PM 2hr excursion.|ANCOVA|Response = Treatment + Baseline + Country + TZD + Sulfo use.||||||<0.001
72420641|NCT00279201|144352665|SUPERIORITY_OR_OTHER|||||||0.201||95.0||||P-value is for Baseline mean all meal time excursions.|ANOVA|ANOVA with treatment, country, TZD use, and sulfo use in model.||||||0.201
72420642|NCT00279201|144352665|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Endpoint mean all meal time excursions.|ANCOVA|Response = Treatment + Baseline + Country + TZD + Sulfo use.||||||<0.001
72420643|NCT00279201|144352665|SUPERIORITY_OR_OTHER|||||||0.956||95.0||||P-value is for Baseline mean of all 2hr postprandial.|ANOVA|ANOVA with treatment, country, TZD use, and sulfo use in model.||||||0.956
72420644|NCT00279201|144352665|SUPERIORITY_OR_OTHER|||||||0.019||95.0||||P-value is for Endpoint mean of all 2hr postprandial.|ANCOVA|Response = Treatment + Baseline + Country + TZD + Sulfo use.||||||0.019
72420645|NCT00279201|144352665|SUPERIORITY_OR_OTHER|||||||0.445||95.0||||P-value is for Baseline mean all premeal.|ANOVA|ANOVA with treatment, country, TZD use, and sulfo use in model.||||||0.445
72420646|NCT00279201|144352665|SUPERIORITY_OR_OTHER|||||||0.371||95.0||||P-value is for Endpoint mean all premeal.|ANOVA|Response = Treatment + Baseline + Country + TZD + Sulfo use.||||||0.371
72420647|NCT00279201|144352665|SUPERIORITY_OR_OTHER|||||||0.848||95.0||||P-value is for Baseline combined AM/PM 2hr postprandial.|ANOVA|ANOVA with treatment, country, TZD use, and sulfo use in model.||||||0.848
72420648|NCT00279201|144352665|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||P-value is for Endpoint combined AM/PM 2hr postprandial.|ANCOVA|Response = Treatment + Baseline + Country + TZD + Sulfo use.||||||0.002
72420649|NCT00279201|144352665|SUPERIORITY_OR_OTHER|||||||0.281||95.0||||P-value is for Baseline AM/PM 2hr postprandial excursion.|ANOVA|ANOVA with treatment, country, TZD use, and sulfo use in model.||||||0.281
72420650|NCT00279201|144352665|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Endpoint AM/PM 2hr postprandial excursion.|ANCOVA|Response = Treatment + Baseline + Country + TZD + Sulfo use.||||||<0.001
72328642|NCT03574610|144181990|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: L middle frontal gyrus||||<0.05
72328643|NCT03574610|144181990|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: R middle frontal gyrus||||<0.05
72420651|NCT00279201|144352665|SUPERIORITY_OR_OTHER|||||||0.588||95.0||||P-value is for Baseline mean all blood glucose values.|ANOVA|ANOVA with treatment, country, TZD use, and sulfo use in model.||||||0.588
72420652|NCT00279201|144352665|SUPERIORITY_OR_OTHER|||||||0.217||95.0||||P-value is for Endpoint mean all blood glucose values.|ANCOVA|Response = Treatment + Baseline + Country + TZD + Sulfo use.||||||0.217
72420653|NCT00279201|144352666|SUPERIORITY_OR_OTHER|||||||0.3||95.0|||||ANCOVA|ANCOVA used with treatment, Baseline HbA1c, country, TZD use, and sulfo use in the model.||||||0.300
72420654|NCT00279201|144352667|SUPERIORITY_OR_OTHER|||||||0.134||95.0||||P-value for \<=7.0%.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel statistic controlling for country, TZD use, and sulfo use.||||||0.134
72420655|NCT00279201|144352667|SUPERIORITY_OR_OTHER|||||||0.089||95.0||||P-value is for \<7.0%|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel statistic controlling for country, TZD use, and sulfo use.||||||0.089
72420656|NCT00279201|144352667|SUPERIORITY_OR_OTHER|||||||0.235||95.0||||P-value is for \<=6.5%.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel statistic controlling for country, TZD use, and sulfo use.||||||0.235
72420657|NCT00279201|144352668|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Change from baseline at Week 24.|ANCOVA|Model: Response = Treatment + Baseline + Country + TZD use + sulfonylurea use.||||||<0.001
72420658|NCT00279201|144352668|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Change from baseline at Week 36.|ANCOVA|Model: Response = Treatment + Baseline + Country + TZD use + sulfonylurea use.||||||<0.001
72420659|NCT00279201|144352668|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Change from baseline at Week 48.|ANCOVA|Model: Response = Treatment + Baseline + Country + TZD use + sulfonylurea use.||||||<0.001
72420660|NCT00279201|144352668|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Change from baseline at Week 60.|ANCOVA|Model: Response = Treatment + Baseline + Country + TZD use + sulfonylurea use.||||||<0.001
72420661|NCT00279201|144352668|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Change from baseline at Week 72.|ANCOVA|Model: Response = Treatment + Baseline + Country + TZD use + sulfonylurea use.||||||<0.001
72420662|NCT00279201|144352668|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Change from baseline at Week 84.|ANCOVA|Model: Response = Treatment + Baseline + Country + TZD use + sulfonylurea use.||||||<0.001
72420663|NCT00279201|144352668|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Change from baseline at Week 96.|ANCOVA|Model: Response = Treatment + Baseline + Country + TZD use + sulfonylurea use.||||||<0.001
72420664|NCT00279201|144352668|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Change from baseline at Week 108|ANCOVA|Model: Response = Treatment + Baseline + Country + TZD use + sulfonylurea use.||||||<0.001
72420665|NCT00279201|144352668|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||P-value is for Change from baseline at Week 120.|ANCOVA|Model: Response = Treatment + Baseline + Country + TZD use + sulfonylurea use.||||||0.002
72328644|NCT03574610|144181990|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: L supplementary motor area (SMA)||||<0.05
72328645|NCT03574610|144181990|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: R SMA||||<0.05
72328646|NCT03574610|144181990|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: L paracentral lobule||||<0.05
72328647|NCT03574610|144181990|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: R paracentral lobule||||<0.05
72328648|NCT03574610|144181990|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: R superior parietal lobule||||<0.05
72328649|NCT03574610|144181990|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: R inferior parietal lobule||||<0.05
72328650|NCT03574610|144181990|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: L superior orbital gyrus||||<0.05
72328651|NCT03574610|144181990|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: L middle orbital gyrus||||<0.05
72328652|NCT03574610|144181990|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: R middle orbital gyrus||||<0.05
72328653|NCT03574610|144181990|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: R calcarine gyrus||||<0.05
72328654|NCT03574610|144181990|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: L calcarine gyrus||||<0.05
72328655|NCT03574610|144181990|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: L anterior cingulate cortex||||<0.05
72328656|NCT03574610|144181990|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: L middle cingulate cortex||||<0.05
72328657|NCT03574610|144181990|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: R middle cingulate cortex||||<0.05
72328658|NCT03574610|144181990|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: R angular gyrus||||<0.05
72328659|NCT03574610|144181990|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: L thalamus||||<0.05
72328660|NCT03574610|144181990|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: R thalamus||||<0.05
72328661|NCT03574610|144181990|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: L precuneus||||<0.05
72328662|NCT03574610|144181990|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: R precuneus||||<0.05
72328663|NCT03574610|144181990|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: R caudate nucleus||||<0.05
72328664|NCT03574610|144181990|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: L putamen||||<0.05
72328665|NCT03574610|144181990|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: L amygdala||||<0.05
72328666|NCT03574610|144181990|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: R insula lobe||||<0.05
72328667|NCT03574610|144181990|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: L rolandic operculum||||<0.05
72328668|NCT03574610|144181990|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: L hippocampus||||<0.05
72328669|NCT03574610|144181990|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: R hippocampus||||<0.05
72328670|NCT03574610|144181990|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: R fusiform gyrus||||<0.05
72328671|NCT03574610|144181990|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: R rolandic operculum||||<0.05
72328672|NCT03574610|144181991|OTHER|||||||0.45||||||Threshold for statistical significance used P-value \<0.05|t-test, 2 sided|Paired t-test||Voided volume - baseline vs post-treatment||||0.45
72328673|NCT03574610|144181991|OTHER|||||||0.39||||||Threshold for statistical significance used P-value \<0.05|t-test, 2 sided|Paired t-test. (Only used the 8 participants that had data for baseline and 4 month follow-up for statistical calculations)||Voided volume - baseline vs 4 month follow-up||||0.39
72328674|NCT03574610|144181991|OTHER|||||||0.014||||||Threshold for statistical significance used P-value \<0.05|t-test, 2 sided|Paired t-test||PVR - baseline vs post-treatment||||0.014
72328675|NCT03574610|144181991|OTHER|||||||0.66||||||Threshold for statistical significance used P-value \<0.05|t-test, 2 sided|Paired t-test. (Only used the 8 participants that had data for baseline and 4 month follow-up for statistical calculations)||PVR - baseline vs 4 month follow-up||||0.66
72328676|NCT03574610|144181991|OTHER|||||||0.31||||||Threshold for statistical significance used P-value \<0.05|t-test, 2 sided|Paired t-test||Bladder capacity - baseline vs post-treatment||||0.31
72328677|NCT03574610|144181991|OTHER|||||||0.001||||||Threshold for statistical significance used P-value \<0.05|t-test, 2 sided|Paired t-test. (Only used the 8 participants that had data for baseline and 4 month follow-up for statistical calculations)||Bladder capacity - baseline vs 4 month follow-up||||0.001
72328678|NCT03574610|144181992|OTHER|||||||0.004||||||Threshold for statistical significance used P-value \<0.05|t-test, 2 sided|Paired t-test||% PVR/BC - baseline vs post-treatment||||0.004
72328679|NCT03574610|144181992|OTHER|||||||0.038||||||Threshold for statistical significance used P-value \<0.05|t-test, 2 sided|Paired t-test. (Only used the 8 participants that had data for baseline and 4 month follow-up for statistical calculations)||%PVR/BC - baseline vs 4 month follow-up||||0.038
72328680|NCT03574610|144181993|OTHER|||||||0.19||||||Threshold for statistical significance used P-value \<0.05|t-test, 2 sided|Paired t-test||Qmax - baseline vs post-treatment||||0.19
72328681|NCT03574610|144181993|OTHER|||||||0.91||||||Threshold for statistical significance used P-value \<0.05|t-test, 2 sided|Paired t-test. (Only used the 8 participants that had data for baseline and 4 month follow-up for statistical calculations)||Max - baseline vs 4 month follow-up||||0.91
72420666|NCT00279201|144352668|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Change from baseline at Endpoint.|ANCOVA|Model: Response = Treatment + Baseline + Country + TZD use + sulfonylurea use.||||||<0.001
72420667|NCT00279201|144352669|SUPERIORITY_OR_OTHER|||||||0.128||95.0||||P-value is for Baseline.|ANOVA|ANOVA with treatment, country, TZD use, and sulfo use in model.||||||0.128
72420668|NCT00279201|144352669|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Week 24.|ANCOVA|Response = Treatment + Baseline + Country + TZD use + Sulfo Use.||||||<0.001
72420669|NCT00279201|144352669|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Week 36.|ANCOVA|Response = Treatment + Baseline + Country + TZD use + Sulfo Use.||||||<0.001
72420670|NCT00279201|144352669|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Week 48.|ANCOVA|Response = Treatment + Baseline + Country + TZD use + Sulfo Use.||||||<0.001
72420671|NCT00279201|144352669|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Week 60.|ANCOVA|Response = Treatment + Baseline + Country + TZD use + Sulfo Use.||||||<0.001
72420672|NCT00279201|144352669|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Week 72.|ANCOVA|Response = Treatment + Baseline + Country + TZD use + Sulfo Use.||||||<0.001
72420673|NCT00279201|144352669|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Week 84.|ANCOVA|Response = Treatment + Baseline + Country + TZD use + Sulfo Use.||||||<0.001
72420674|NCT00279201|144352669|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Week 96.|ANCOVA|Response = Treatment + Baseline + Country + TZD use + Sulfo Use.||||||<0.001
72420675|NCT00279201|144352669|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Week 108.|ANCOVA|Response = Treatment + Baseline + Country + TZD use + Sulfo Use.||||||<0.001
72420676|NCT00279201|144352669|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||P-value is for Week 120.|ANCOVA|Response = Treatment + Baseline + Country + TZD use + Sulfo Use.||||||0.002
72420677|NCT00279201|144352669|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Endpoint.|ANCOVA|Response = Treatment + Baseline + Country + TZD use + Sulfo Use.||||||<0.001
72420678|NCT00279201|144352670|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Week 24.|ANOVA|Model: Treatment + Country + TZD use + sulfonylurea use.||||||<0.001
72328682|NCT03574610|144181994|OTHER|||||||0.13||||||Threshold for statistical significance used P-value \<0.05|t-test, 2 sided|Paired t-test||Liverpool nomogram percentile - baseline vs post-treatment||||0.13
72420679|NCT00279201|144352670|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Week 36.|ANOVA|Model: Treatment + Country + TZD use + sulfonylurea use.||||||<0.001
72420680|NCT00279201|144352670|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Week 48.|ANOVA|Model: Treatment + Country + TZD use + sulfonylurea use.||||||<0.001
72420681|NCT00279201|144352670|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Week 60.|ANOVA|Model: Treatment + Country + TZD use + sulfonylurea use.||||||<0.001
72420682|NCT00279201|144352670|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Week 72.|ANOVA|Model: Treatment + Country + TZD use + sulfonylurea use.||||||<0.001
72420683|NCT00279201|144352670|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Week 84.|ANOVA|Model: Treatment + Country + TZD use + sulfonylurea use.||||||<0.001
72420684|NCT00279201|144352670|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Week 96.|ANOVA|Model: Treatment + Country + TZD use + sulfonylurea use.||||||<0.001
72420685|NCT00279201|144352670|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Week 108.|ANOVA|Model: Treatment + Country + TZD use + sulfonylurea use.||||||<0.001
72420686|NCT00279201|144352670|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Week 120.|ANOVA|Model: Treatment + Country + TZD use + sulfonylurea use.||||||<0.001
72420687|NCT00279201|144352670|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Endpoint.|ANOVA|Model: Treatment + Country + TZD use + sulfonylurea use.||||||<0.001
72420688|NCT00279201|144352671|SUPERIORITY_OR_OTHER|||||||0.37||95.0||||P-value is for Overall hypoglycemic episodes endpoint.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel statistic controlling for country, TZD use, and sulfo use.||||||0.370
72420689|NCT00279201|144352671|SUPERIORITY_OR_OTHER|||||||0.006||95.0||||P-Value for Overall hypoglycemia episodes.|Cochran-Mantel-Haenszel|Controlling for country, TZD use, and sulfo use.||||||0.006
72420690|NCT00279201|144352671|SUPERIORITY_OR_OTHER|||||||0.397||95.0||||P-value is for Nocturnal episodes endpoint.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel statistic controlling for country, TZD use, and sulfo use.||||||0.397
72420691|NCT00279201|144352671|SUPERIORITY_OR_OTHER|||||||0.253||95.0||||P-value is for Nocturnal episodes overall.|Cochran-Mantel-Haenszel|Controlling for country, TZD use, and sulfo use.||||||0.253
72420692|NCT00279201|144352671|SUPERIORITY_OR_OTHER|||||||0.893||95.0||||P-value is for Severe episodes endpoint.|Cochran-Mantel-Haenszel|Controlling for country, TZD use, and sulfo use.||||||0.893
72328683|NCT03574610|144181994|OTHER|||||||0.26||||||Threshold for statistical significance used P-value \<0.05|t-test, 2 sided|Paired t-test. (Only used the 8 participants that had data for baseline and 4 month follow-up for statistical calculations)||Liverpool nomogram percentile - baseline vs 4 month follow-up||||0.26
72328684|NCT03574610|144181995|OTHER|||||||0.4||||||Threshold for statistical significance used P-value \<0.05|t-test, 2 sided|Paired t-test||UDI-6 Q1 - baseline vs post-treatment||||0.40
72328685|NCT03574610|144181995|OTHER|||||||0.086||||||Threshold for statistical significance used P-value \<0.05|t-test, 2 sided|Paired t-test. (Only used the 8 participants that had data for baseline and 4 month follow-up for statistical calculations)||UDI-6 Q1 - baseline vs 4 month follow-up||||0.086
72328686|NCT03574610|144181995|OTHER|||||||0.54||||||Threshold for statistical significance used P-value \<0.05|t-test, 2 sided|Paired t-test.||UDI-6 Q2 - baseline vs post-treatment||||0.54
72328687|NCT03574610|144181995|OTHER|||||||0.19||||||Threshold for statistical significance used P-value \<0.05|t-test, 2 sided|Paired t-test. (Only used the 8 participants that had data for baseline and 4 month follow-up for statistical calculations)||UDI-6 Q2 - baseline vs 4 month follow-up||||0.19
72420693|NCT00279201|144352671|SUPERIORITY_OR_OTHER|||||||0.391||95.0||||P-value is for Severe episodes overall.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel statistic controlling for country, TZD use, and sulfo use.||||||0.391
72420694|NCT00279201|144352672|SUPERIORITY_OR_OTHER|||||||0.497||95.0||||P-value for Hypoglycemia episodes Endpoint.|ANOVA|Response = Treatment + Country + TZD use + Sulfo use.||||||0.497
72420695|NCT00279201|144352672|SUPERIORITY_OR_OTHER|||||||0.071||95.0||||P-value is for Hypoglycemia episodes Overall.|ANOVA|Response = Treatment + Country + TZD use + Sulfo use.||||||0.071
72420696|NCT00279201|144352672|SUPERIORITY_OR_OTHER|||||||0.065||95.0||||P-value is for Nocturnal episodes Endpoint.|ANOVA|Response = Treatment + Country + TZD use + Sulfo use.||||||0.065
72420697|NCT00279201|144352672|SUPERIORITY_OR_OTHER|||||||0.021||95.0||||P-value is for Nocturnal episodes Overall.|ANOVA|Response = Treatment + Country + TZD use + Sulfo use.||||||0.021
72420698|NCT00279201|144352672|SUPERIORITY_OR_OTHER|||||||0.2||95.0||||P-value is for Severe episodes Endpoint.|ANOVA|Response = Treatment + Country + TZD use + Sulfo use.||||||0.200
72420699|NCT00279201|144352672|SUPERIORITY_OR_OTHER|||||||0.208||95.0||||P-value is for Severe episodes Overall.|ANOVA|Response = Treatment + Country + TZD use + Sulfo use.||||||0.208
72420700|NCT00279201|144352673|SUPERIORITY_OR_OTHER|||||||0.004||95.0||||P-value is for Change.|ANCOVA|ANCOVA model with treatment, baseline, country, TZD use and sulfo use.||||||0.004
72420701|NCT00279201|144352674|SUPERIORITY_OR_OTHER|||||||0.204||95.0||||P-value is for Baseline at Week 0.|ANOVA|ANOVA used with treatment, country, TZD use and Sulfo use in the model.||||||0.204
72420702|NCT00279201|144352674|SUPERIORITY_OR_OTHER|||||||0.017||95.0||||P-Value is for Change from baseline to endpoint.|ANCOVA|ANCOVA used with treatment, Baseline HbA1c, country, TZD use and sulfo use in the model.||||||0.017
72420703|NCT00279201|144352674|SUPERIORITY_OR_OTHER|||||||0.02||95.0||||P-value is for Change Week 24 to Week 120 endpoint.|ANCOVA|ANCOVA used with treatment, Baseline HbA1c, country, TZD use and sulfo use in the model.||||||0.020
72328688|NCT03574610|144181995|OTHER|||||||0.04||||||Threshold for statistical significance used P-value \<0.05|t-test, 2 sided|Paired t-test||UDI-6 Q5 - baseline vs post-treatment||||0.04
72420704|NCT00279201|144352675|SUPERIORITY_OR_OTHER|||||||0.036||95.0|||||ANOVA|ANOVA with maintained goal/did not maintain goal, country, TZD use, and sulfo use in model.||||||0.036
72420705|NCT00279201|144352676|SUPERIORITY_OR_OTHER|||||||0.708||95.0|||||ANOVA|From ANOVA with maintained goal/did not maintain goal, country, TZD use, and sulfo use in model.||||||0.708
72420706|NCT00279201|144352677|SUPERIORITY_OR_OTHER|||||||0.028||95.0|||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by country, TZD use, and Sulfo use.||||||0.028
72420707|NCT00279201|144352678|SUPERIORITY_OR_OTHER|||||||0.738||95.0|||||Cochran-Mantel-Haenszel|Stratified by country, TZD use, and sulfo use.||||||0.738
72420708|NCT00279201|144352679|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA|ANOVA with maintained goal/did not maintain goal, country, TZD use, and sulfo use in model.||||||<0.001
72420709|NCT00279201|144352680|SUPERIORITY_OR_OTHER|||||||0.043||95.0|||||ANOVA|ANOVA with maintained goal/did not maintain goal, country, TZD use, and sulfo use in model.||||||0.043
72420710|NCT00279201|144352681|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by country, TZD use, and sulfo use.||||||<0.001
72420711|NCT00279201|144352682|SUPERIORITY_OR_OTHER|||||||0.032||95.0|||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by country, TZD use, and sulfo use.||||||0.032
72420712|NCT00279201|144352683|SUPERIORITY_OR_OTHER|||||||0.037||95.0||||P-value is for Sulfonylurea/TZD.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by country only.||||||0.037
72420713|NCT00279201|144352683|SUPERIORITY_OR_OTHER|||||||0.025||95.0||||P-value is for Sulfonylurea/metformin.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by country only.||||||0.025
72420714|NCT00279201|144352683|SUPERIORITY_OR_OTHER|||||||0.132||95.0||||P-value is for Metformin/TZD.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by country only.||||||0.132
72328689|NCT03574610|144181995|OTHER|||||||0.026||||||Threshold for statistical significance used P-value \<0.05|t-test, 2 sided|Paired t-test. (Only used the 8 participants that had data for baseline and 4 month follow-up for statistical calculations)||UDI-6 5 - baseline vs 4 month follow-up||||0.026
72328690|NCT03574610|144181996|OTHER|||||||0.044||||||Threshold for statistical significance used P-value \<0.05|t-test, 2 sided|Paired t-test||AUASS Q3 - baseline vs post-treatment||||0.044
72328691|NCT03574610|144181996|OTHER|||||||0.017||||||Threshold for statistical significance used P-value \<0.05|t-test, 2 sided|Paired t-test. (Only used the 8 participants that had data for baseline and 4 month follow-up for statistical calculations)||AUASS Q3 - baseline vs 4 month follow-up||||0.017
72328692|NCT03574610|144181996|OTHER|||||||0.54||||||Threshold for statistical significance used P-value \<0.05|t-test, 2 sided|Paired t-test||AUASS Q5 - baseline vs post-treatment||||0.54
72420715|NCT00279201|144352683|SUPERIORITY_OR_OTHER|||||||0.849||95.0||||P-value is for Sulfonylurea/metformin/TZD.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by country only.||||||0.849
72420716|NCT00279201|144352684|SUPERIORITY_OR_OTHER|||||||0.006||95.0||||P-value is for Sulfonylurea/TZD|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by country only.||||||0.006
72328693|NCT03574610|144181996|OTHER|||||||0.503||||||Threshold for statistical significance used P-value \<0.05|t-test, 2 sided|Paired t-test. (Only used the 8 participants that had data for baseline and 4 month follow-up for statistical calculations)||AUASS Q5 - baseline vs 4 month follow-up||||0.503
72328694|NCT03574610|144181996|OTHER|||||||0.023||||||Threshold for statistical significance used P-value \<0.05|t-test, 2 sided|Paired t-test||AUASS Q7 - baseline vs post-treatment||||0.023
72420717|NCT00279201|144352684|SUPERIORITY_OR_OTHER|||||||0.048||95.0||||P-value is for Sulfonylurea/metformin.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by country only.||||||0.048
72420718|NCT00279201|144352684|SUPERIORITY_OR_OTHER|||||||0.258||95.0||||P-value is for Metformin/TZD.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by country only.||||||0.258
72420719|NCT00279201|144352684|SUPERIORITY_OR_OTHER|||||||0.848||95.0||||P-value is for Sulfonylurea/metformin/TZD.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by country only.||||||0.848
72328695|NCT03574610|144181996|OTHER|||||||0.049||||||Threshold for statistical significance used P-value \<0.05|t-test, 2 sided|Paired t-test. (Only used the 8 participants that had data for baseline and 4 month follow-up for statistical calculations)||AUASS Q7 - baseline vs 4 month follow-up||||0.049
72328696|NCT03574610|144181996|OTHER|||||||0.089||||||Threshold for statistical significance used P-value \<0.05|t-test, 2 sided|Paired t-test||AUASS Q8 - baseline vs post-treatment||||0.089
72328697|NCT03574610|144181996|OTHER|||||||0.161||||||Threshold for statistical significance used P-value \<0.05|t-test, 2 sided|Paired t-test. (Only used the 8 participants that had data for baseline and 4 month follow-up for statistical calculations)||AUASS Q8 - baseline vs 4 month follow-up||||0.161
72328698|NCT03574610|144181997|OTHER|||||||0.01||||||Threshold for statistical significance used P-value \<0.05|t-test, 2 sided|Paired t-test||NBSS (Incontinence) - baseline vs post-treatment||||0.010
72328699|NCT03574610|144181997|OTHER|||||||0.41||||||Threshold for statistical significance used P-value \<0.05|t-test, 2 sided|Paired t-test. (Only used the 8 participants that had data for baseline and 4 month follow-up for statistical calculations)||NBSS (Incontinence) - baseline vs 4 month follow-up||||0.41
72328700|NCT03574610|144181997|OTHER|||||||0.32||||||Threshold for statistical significance used P-value \<0.05|t-test, 2 sided|Paired t-test||NBSS (Storage and Voiding) - baseline vs post-treatment||||0.32
72328701|NCT03574610|144181997|OTHER|||||||0.02||||||Threshold for statistical significance used P-value \<0.05|t-test, 2 sided|Paired t-test. (Only used the 8 participants that had data for baseline and 4 month follow-up for statistical calculations)||NBSS (Storage and Voiding) - baseline vs 4 month follow-up||||0.02
72328702|NCT03574610|144181997|OTHER|||||||0.34||||||Threshold for statistical significance used P-value \<0.05|t-test, 2 sided|Paired t-test||NBSS (Consequences) - baseline vs post-treatment||||0.34
72328703|NCT03574610|144181997|OTHER|||||||0.61||||||Threshold for statistical significance used P-value \<0.05|t-test, 2 sided|Paired t-test. (Only used the 8 participants that had data for baseline and 4 month follow-up for statistical calculations)||NBSS (Consequences) - baseline vs 4 month follow-up||||0.61
72328704|NCT03574610|144181997|OTHER|||||||0.02||||||Threshold for statistical significance used P-value \<0.05|t-test, 2 sided|Paired t-test. (Only used the 8 participants that had data for baseline and 4 month follow-up for statistical calculations)||NBSS (QoL) - baseline vs post-treatment||||0.02
72328705|NCT03574610|144181997|OTHER|||||||0.07||||||Threshold for statistical significance used P-value \<0.05|t-test, 2 sided|Paired t-test. (Only used the 8 participants that had data for baseline and 4 month follow-up for statistical calculations)||NBSS (QoL) - baseline vs 4 month follow-up||||0.07
72328706|NCT01032954|144181998|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05||||||P-value threshold for significance: \<0.05|GLM= GENERAL LINEAR MODELS WITH REPEATED|||||||<0.05
72328707|NCT01032954|144181999|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05||||||P-value threshold for significance: \<0.05|GLM|||||||<0.05
72328708|NCT03759639|144182065|SUPERIORITY||Hodges-Lehmann Estimator|1.0||||0.029|TWO_SIDED|90.0|0.25|1.75|||1-sided Wilcoxon signed-rank test|||||1.75|0.25|0.029
72328709|NCT03759639|144182067|SUPERIORITY||Hodges-Lehmann Estimator|0.13||||0.318|TWO_SIDED|90.0|-0.25|0.5|||1-sided Wilcoxon signed-rank test|||||0.50|-0.25|0.318
72328710|NCT03759639|144182070|SUPERIORITY||Hodges-Lehmann Estimator|0.0854||||0.084|TWO_SIDED|90.0|-0.0123|0.1777|||1-sided Wilcoxon signed-rank test|||Treatment With IB1001||0.1777|-0.0123|0.084
72328711|NCT03759639|144182070|SUPERIORITY||Hodges-Lehmann Estimator|-0.0399||||0.315|TWO_SIDED|90.0|-0.1269|0.1031|||1-sided Wilcoxon signed-rank test|||Post-Treatment Washout||0.1031|-0.1269|0.315
72328712|NCT03759639|144182071|SUPERIORITY||Hodges-Lehmann Estimator|-1.25||||0.001|TWO_SIDED|90.0|-1.75|-0.5|||1-sided Wilcoxon signed-rank test|||Treatment With IB1001||-0.50|-1.75|0.001
72328713|NCT03759639|144182071|SUPERIORITY||Hodges-Lehmann Estimator|1.25||||0.002|TWO_SIDED|90.0|0.5|2.0|||1-sided Wilcoxon signed-rank test|||Post-Treatment Washout||2.00|0.50|0.002
72328714|NCT03759639|144182073|SUPERIORITY||Hodges-Lehmann Estimator|0.0||||0.121|TWO_SIDED|90.0|-0.021|0.0|||1-sided Wilcoxon signed-rank test|||Treatment with IB1001||0.000|-0.021|0.121
72328715|NCT03759639|144182073|SUPERIORITY||Hodges-Lehmann Estimator|0.021||||0.056|TWO_SIDED|90.0|0.0|0.042|||1-sided Wilcoxon signed-rank test|||Post-Treatment Washout||0.042|0.000|0.056
72328716|NCT03759639|144182074|SUPERIORITY||Mean Difference (Net)|3.4|||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Treatment With IB1001||||<0.001
72328717|NCT03759639|144182074|SUPERIORITY||Mean Difference (Net)|4.5||||0.006|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Post-Treatment Washout||||0.006
72328718|NCT03759639|144182075|SUPERIORITY||Mean Difference (Net)|3.4||||0.005|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Treatment With IB1001||||0.005
72328719|NCT03759639|144182075|SUPERIORITY||Mean Difference (Net)|4.4||||0.038|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Treatment With IB1001||||0.038
72328720|NCT03759639|144182076|SUPERIORITY||Mean Difference (Net)|3.3||||0.003|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Treatment with IB1001||||0.003
72328721|NCT03759639|144182076|SUPERIORITY||Mean Difference (Net)|4.4||||0.034|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Post-Treatment Washout||||0.034
72328722|NCT00958360|144182077|SUPERIORITY_OR_OTHER|||||||0.05|||||||t-test, 2 sided|||||||0.05
72328723|NCT00958360|144182078|SUPERIORITY_OR_OTHER|||||||0.13|||||||t-test, 2 sided|||||||0.13
72328724|NCT00958360|144182079|SUPERIORITY_OR_OTHER|||||||0.05|||||||t-test, 2 sided|||||||0.05
72328725|NCT00958360|144182080|SUPERIORITY_OR_OTHER|||||||0.013|||||||t-test, 2 sided|||||||0.013
72328726|NCT00958360|144182081|SUPERIORITY_OR_OTHER|||||||0.013|||||||t-test, 2 sided|||||||0.013
72328727|NCT00336284|144182084|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||||||<0.001
72328728|NCT00336284|144182085|NON_INFERIORITY_OR_EQUIVALENCE|Sample size of the study is based on the safety endpoint and based on a Blackwelder type test of non inferiority with the standard design criteria: Type I error (one-sided), statistical power of 80%, and 2:1 randomization. The evaluation of the primary safety endpoint was based on an exact binomial non-inferiority test comparing the proportions of patient deaths, strokes or surgical interventions.||||||0.005||95.0|||||Exact binomial test for non-inferiority|1-sided||||||0.005
72328729|NCT00336284|144182086|SUPERIORITY_OR_OTHER|||||||0.016||95.0|||||t-test, 2 sided|||||||0.016
72328730|NCT03782259|144182106|SUPERIORITY||||||<|0.0125||||||Given that there were 4 separate comparisons of the primary outcomes, the level of significance was adjusted from 0.05 to 0.0125 (.05/4) using the Bonferroni correction.|Wilcoxon (Mann-Whitney)|There were no adjustments for covariates.||||||< 0 .0125
72328731|NCT03782259|144182107|SUPERIORITY||||||<|0.0125||||||Given that there were 4 separate comparisons of the primary outcomes, the level of significance was adjusted from 0.05 to 0.0125 (.05/4) using the Bonferroni correction.|Wilcoxon (Mann-Whitney)|There were no adjustments for covariates.||||||< 0 .0125
72328732|NCT05507567|144182127|OTHER|||||||0.0331|||||||Chi-squared|||A priori primary analysis group||||0.0331
72328733|NCT05507567|144182128|OTHER|||||||0.1427||||||Hodges-Lehmann (H-L) estimation|Wilcoxon (Mann-Whitney)|1-sided Wilcoxon rank-sum||||||0.1427
72328734|NCT05507567|144182129|OTHER|||||||0.1307||||||H-L estimation|Wilcoxon (Mann-Whitney)|1-sided Wilcoxon rank-sum||||||0.1307
72328735|NCT05507567|144182130|OTHER|||||||0.0382||||||H-L estimation|Wilcoxon (Mann-Whitney)|1-sided Wilcoxon rank-sum||||||0.0382
72328736|NCT05507567|144182131|OTHER|||||||0.011||||||H-L estimation|Wilcoxon (Mann-Whitney)|1-sided Wilcoxon rank-sum||||||0.0110
72328737|NCT01771991|144182152|SUPERIORITY||sum of scores|453.0|STANDARD_DEVIATION|39.6||0.57|TWO_SIDED||||||Wilcoxon Rank-Sum||Standard Deviation under the Null hypothesis for each group.|||||0.57
72328738|NCT01771991|144182153|SUPERIORITY||Mean Difference (Final Values)|0.17|STANDARD_DEVIATION|1.5||0.65|TWO_SIDED|95.0|-0.6|0.95|||t-test, 2 sided|||Looking at the difference in pain change over time. The null hypothesis is there was no difference between the two treatment groups.||0.95|-0.60|0.65
72328739|NCT01771991|144182154|SUPERIORITY||Mean Difference (Final Values)|2.63|STANDARD_DEVIATION|17.79||0.57|TWO_SIDED|95.0|-6.65|11.91|||t-test, 2 sided|||Looking at the difference in range of motion change over time. The null hypothesis is there was no difference between the two treatment groups.||11.91|-6.65|0.57
72328740|NCT01399229|144182155|NON_INFERIORITY_OR_EQUIVALENCE|"Agreement between SureCALL® and Tocodynamometer Contraction Peak Times~Null hypothesis: The mean peak difference between RMS and TOCO is equal to 0. Alternative hypothesis: The mean peak difference is not equal to 0."|Mean Difference (Net)|0.99|STANDARD_ERROR_OF_MEAN|1.4086||0.4901|TWO_SIDED|95.0|-28.74|30.72|||Mixed Models Analysis|||||30.72|-28.74|0.4901
72328741|NCT02526212|144182164|SUPERIORITY|||||||0.44|||||||Fisher Exact|||Due to the small sample size, planned analyses that assessed for clustering by group assignment or primary care physician could not be conducted. Chi square using fisher's exact test was conducted to investigate differences in abstinence between study arms.||||0.44
72328742|NCT02526212|144182167|SUPERIORITY|||||||0.2|||||||t-test, 2 sided|||Each of the 17 items were rated on a scale from 1 to 5. For each participant, the scores from these items were summed and divided by 17 for an average satisfaction score. The average satisfaction score was compared between study arms.||||0.20
72328743|NCT03645096|144182170|SUPERIORITY||Mean Difference (Final Values)|0.0493|STANDARD_ERROR_OF_MEAN|0.0554||0.195|TWO_SIDED|95.0|-0.0703|0.1689||Statistical significance is evaluated at p (one-tailed) \<= .05.|t-test, 1 sided|Paired samples t-test with corrected standard deviation of the difference.|Mean Difference = placebo - pregnenolone (500 mg)|"Null Hypothesis: Amygdala-PCC functional connectivity (z-score) at 500 mg will be less than or equal to that at placebo.~Alternative Hypothesis: Amygdala-PCC functional connectivity (z-score) at 500 mg will be greater than that at placebo."||0.1689|-0.0703|.195
72328744|NCT03645096|144182170|SUPERIORITY||Mean Difference (Final Values)|0.0262|STANDARD_ERROR_OF_MEAN|0.0565||0.325|TWO_SIDED|95.0|-0.0943|0.1467||Statistical significance is evaluated at p (one-tailed) \<= .05.|t-test, 1 sided|Paired samples t-test with corrected standard deviation of the difference.|Mean Difference = placebo - pregnenolone (800 mg)|"Null Hypothesis: Amygdala-PCC functional connectivity (z-score) at 800 mg will be less than or equal to that at placebo.~Alternative Hypothesis: Amygdala-PCC functional connectivity (z-score) at 800 mg will be greater than that at placebo."||0.1467|-0.0943|.325
72328745|NCT03645096|144182171|SUPERIORITY||Mean Difference (Final Values)|-0.0071|STANDARD_ERROR_OF_MEAN|0.0878||0.468|TWO_SIDED|95.0|-0.1969|0.1827||Statistical significance is evaluated at p (one-tailed) \<= .05.|t-test, 1 sided|Paired samples t-test with corrected standard deviation of the difference.|Mean Difference = placebo - pregnenolone (500 mg)|"Null Hypothesis: dlPFC-Insula functional connectivity (z-score) at 500 mg will be less than or equal to that at placebo.~Alternative Hypothesis: dlPFC-Insula functional connectivity (z-score) at 500 mg will be greater than that at placebo."||0.1827|-0.1969|.468
72420720|NCT00279201|144352685|SUPERIORITY_OR_OTHER|||||||0.004||95.0|||||ANOVA|ANOVA with maintained goal/did not maintain goal, country, TZD use, and sulfo use in model.||||||0.004
72420721|NCT00279201|144352686|SUPERIORITY_OR_OTHER|||||||0.553||95.0|||||ANOVA|From ANOVA with maintained goal/did not maintain goal, country, TZD use, and sulfo use in model.||||||0.553
72328746|NCT03645096|144182171|SUPERIORITY||Mean Difference (Final Values)|0.0097|STANDARD_ERROR_OF_MEAN|0.0891||0.458|TWO_SIDED|95.0|-0.1803|0.1996||Statistical significance is evaluated at p (one-tailed) \<= .05.|t-test, 1 sided|Paired samples t-test with corrected standard deviation of the difference.|Mean Difference = placebo - pregnenolone (800 mg)|"Null Hypothesis: dlPFC-Insula functional connectivity (z-score) at 800 mg will be less than or equal to that at placebo.~Alternative Hypothesis: dlPFC-Insula functional connectivity (z-score) at 800 mg will be greater than that at placebo."||0.1996|-0.1803|.458
72328747|NCT03645096|144182172|SUPERIORITY||Mean Difference (Final Values)|0.0038|STANDARD_ERROR_OF_MEAN|0.0078||0.316|TWO_SIDED|95.0|-0.0132|0.0209||Paired samples t-test with corrected standard deviation of the difference.|t-test, 1 sided|Paired samples t-test with corrected standard deviation of the difference.|Mean Difference = placebo - pregnenolone (500 mg)|"Null Hypothesis: GABA concentration (mM) at 500 mg will be less than or equal to that at placebo.~Alternative Hypothesis: GABA concentration (mM) at 500 mg will be greater than that at placebo."||0.0209|-0.0132|.316
72328748|NCT03645096|144182172|SUPERIORITY||Mean Difference (Final Values)|0.0131|STANDARD_ERROR_OF_MEAN|0.0084||0.071|TWO_SIDED|95.0|-0.005|0.0312||Statistical significance is evaluated at p (one-tailed) \<= .05.|t-test, 1 sided|Paired samples t-test with corrected standard deviation of the difference.|Mean Difference = placebo - pregnenolone (800 mg)|"Null Hypothesis: GABA concentration (mM) at 500 mg will be less than or equal to that at placebo.~Alternative Hypothesis: GABA concentration (mM) at 500 mg will be greater than that at placebo."||0.0312|-0.0050|.071
72328749|NCT03645096|144182173|SUPERIORITY||Mean Difference (Final Values)|-11322.45|STANDARD_ERROR_OF_MEAN|3750.52||0.006|TWO_SIDED|95.0|-19577.27|-3067.62||Statistical significance is evaluated at p (one-tailed) \<= .05.|t-test, 1 sided|Paired samples t-test with corrected standard deviation of the difference.|Mean Difference = placebo - pregnenolone (500 mg)|"Null Hypothesis: Pregnenolone level (pg/mL) at 500 mg will be less than or equal to that at placebo.~Alternative Hypothesis: Pregnenolone level (pg/mL) at 500 mg will be greater than that at placebo."||-3067.62|-19577.27|.006
72328750|NCT03645096|144182173|SUPERIORITY||Mean Difference (Final Values)|-11828.78|STANDARD_ERROR_OF_MEAN|3620.42||0.003|TWO_SIDED|95.0|-19650.24|-4007.33||Statistical significance is evaluated at p (one-tailed) \<= .05.|t-test, 1 sided|Paired samples t-test with corrected standard deviation of the difference.|Mean Difference = placebo - pregnenolone (800 mg)|"Null Hypothesis: Pregnenolone level (pg/mL) at 800 mg will be less than or equal to that at placebo.~Alternative Hypothesis: Pregnenolone level (pg/mL) at 800 mg will be greater than that at placebo."||-4007.33|-19650.24|.003
72328751|NCT03645096|144182174|SUPERIORITY||Mean Difference (Final Values)|-2523.58|STANDARD_ERROR_OF_MEAN|545.83||0.001|TWO_SIDED|95.0|-3724.93|-1322.22||Statistical significance is evaluated at p (one-tailed) \<= .05.|t-test, 1 sided|Paired samples t-test with corrected standard deviation of the difference.|Mean Difference = placebo - pregnenolone (500 mg)|"Null Hypothesis: Allopregnanolone level (pg/mL) at 500 mg will be less than or equal to that at placebo.~Alternative Hypothesis: Allopregnanolone level (pg/mL) at 500 mg will be greater than that at placebo."||-1322.22|-3724.93|.001
72328752|NCT03645096|144182174|SUPERIORITY||Mean Difference (Final Values)|-2480.62|STANDARD_ERROR_OF_MEAN|582.63||0.001|TWO_SIDED|95.0|-3739.32|-1221.93||Statistical significance is evaluated at p (one-tailed) \<= .05.|t-test, 1 sided|Paired samples t-test with corrected standard deviation of the difference.|Mean Difference = placebo - pregnenolone (800 mg)|"Null Hypothesis: Allopregnanolone level (pg/mL) at 800 mg will be less than or equal to that at placebo.~Alternative Hypothesis: Allopregnanolone level (pg/mL) at 800 mg will be greater than that at placebo."||-1221.93|-3739.32|.001
72328753|NCT03645096|144182175|NON_INFERIORITY|"Using the two one-sided test (TOST) procedure (Schuirmann, 1987), equivalence is established at the α significance level if a (1-2α) × 100% confidence interval for the difference in efficacies (new - current) is contained within the interval (-δ, δ)~Schuirmann, D. J. (1987). A comparison of the two one-sided tests procedure and the power approach for assessing the equivalence of average bioavailability. Journal of pharmacokinetics and biopharmaceutics, 15, 657-680."|Mean Difference (Final Values)|0.7059|STANDARD_ERROR_OF_MEAN|1.6377||0.336|TWO_SIDED|95.0|-2.7659|4.1777||Statistical significance is evaluated at p (one-tailed) \<= .05.|t-test, 1 sided|Paired samples t-test with corrected standard deviation of the difference.|Mean Difference = placebo - pregnenolone (500 mg)|"Null Hypothesis: SAFTEE (total) scores at 500 mg will be greater than or equal to that at placebo.~Alternative Hypothesis: SAFTEE (total) scores at 500 mg will be less than that at placebo."||4.1777|-2.7659|.336
72328754|NCT03645096|144182175|NON_INFERIORITY|"Using the two one-sided test (TOST) procedure (Schuirmann, 1987), equivalence is established at the α significance level if a (1-2α) × 100% confidence interval for the difference in efficacies (new - current) is contained within the interval (-δ, δ)~Schuirmann, D. J. (1987). A comparison of the two one-sided tests procedure and the power approach for assessing the equivalence of average bioavailability. Journal of pharmacokinetics and biopharmaceutics, 15, 657-680."|Mean Difference (Final Values)|-2.5|STANDARD_ERROR_OF_MEAN|3.4662||0.24|TWO_SIDED|95.0|-9.8131|4.8131||Statistical significance is evaluated at p (one-tailed) \<= .05.|t-test, 1 sided|Paired samples t-test with corrected standard deviation of the difference.|Mean Difference = placebo - pregnenolone (800 mg)|"Null Hypothesis: SAFTEE (total) scores at 800 mg will be greater than or equal to that at placebo.~Alternative Hypothesis: SAFTEE (total) scores at 800 mg will be less than that at placebo."||4.8131|-9.8131|.240
72328755|NCT00040742|144182177|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.566|STANDARD_ERROR_OF_MEAN|0.145||0.017|TWO_SIDED|||||The p-value was adjusted using theTukey-Kramer method.|Mixed Models Analysis|Mixed model analyses and Type 3 tests of fixed effects using the Kenward-Roger degrees of freedom procedure were used.|The estimation parameter (mean difference) is the difference in mean change from baseline (post-intervention - baseline) between groups (0.5 gm ginger - placebo). Negative values are favorable for the ginger group.|"H0: Mean difference between 0.5g and placebo of change from baseline of Peak Acute Nausea = 0.~Ha: Mean difference between 0.5g and placebo of change from baseline of Peak Acute Nausea \> 0. (Two-sided)"||||.017
72420722|NCT00279201|144352687|SUPERIORITY_OR_OTHER|||||||0.01||95.0||||P-value is for Mean of all post meals blood glucose.|ANOVA|ANOVA with maintained goal/did not maintain goal, country, TZD use, and sulfo use in model.||||||0.010
72420723|NCT00279201|144352687|SUPERIORITY_OR_OTHER|||||||0.035||95.0||||P-value is for Average of all blood glucose.|ANOVA|ANOVA with maintained goal/did not maintain goal, country, TZD use, and sulfo use in model.||||||0.035
72420724|NCT00279201|144352688|SUPERIORITY_OR_OTHER|||||||0.516||95.0||||P-value is for Mean of post-meals blood glucose.|ANOVA|From ANOVA with maintained goal/did not maintain goal, country, TZD use, and sulfo use in model.||||||0.516
72420725|NCT00279201|144352688|SUPERIORITY_OR_OTHER|||||||0.425||95.0||||P-value is for Average of all blood glucose.|ANOVA|From ANOVA with maintained goal/did not maintain goal, country, TZD use, and sulfo use in model.||||||0.425
72328756|NCT00040742|144182177|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.506|STANDARD_ERROR_OF_MEAN|0.141||0.036|TWO_SIDED|||||The p-value was adjusted using theTukey-Kramer method.|Mixed Models Analysis|Mixed model analyses and Type 3 tests of fixed effects using the Kenward-Roger degrees of freedom procedure were used.|The estimation parameter (mean difference) is the difference in mean change from baseline (post-intervention - baseline) between groups (1 gm ginger - placebo). Negative values are favorable for the ginger group.|"H0: Mean difference between 1.0g and placebo of change from baseline of Peak Acute Nausea = 0.~Ha: Mean difference between 1.0g and placebo of change from baseline of Peak Acute Nausea \> 0. (Two-sided)"||||0.036
72328757|NCT00040742|144182177|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.269|STANDARD_ERROR_OF_MEAN|0.137||0.431|TWO_SIDED|||||The p-value was adjusted using theTukey-Kramer method.|Mixed Models Analysis|Mixed model analyses and Type 3 tests of fixed effects using the Kenward-Roger degrees of freedom procedure were used.|The estimation parameter (mean difference) is the difference in mean change from baseline (post-intervention - baseline) between groups (1.5 gm ginger - placebo). Negative values are favorable for the ginger group.|"H0: Mean difference between 1.5g and placebo of change from baseline of Peak Acute Nausea = 0.~Ha: Mean difference between 1.5g and placebo of change from baseline of Peak Acute Nausea \> 0. (Two-sided)"||||0.431
72328758|NCT00040742|144182177|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.47|STANDARD_ERROR_OF_MEAN|0.16||0.003|TWO_SIDED||||||Mixed Models Analysis|Parameter estimated using a contrast.|The estimation parameter (mean difference) is the difference in mean change from baseline (post-intervention - baseline) between groups (any ginger - placebo). Negative values are favorable for the ginger group.|"Placebo vs. Any Ginger. H0: Mean difference between \[(0.5g +1.0g +1.5g) / 3\] and placebo of change from baseline of Peak Acute Nausea = 0.~Ha: Mean difference between \[(0.5g +1.0g +1.5g) / 3\] and placebo of change from baseline of Peak Acute Nausea \> 0. (Two-sided)"||||0.003
72328759|NCT00040742|144182178|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.441|STANDARD_ERROR_OF_MEAN|0.127||0.046|TWO_SIDED|||||The p-value was adjusted using theTukey-Kramer method|Mixed Models Analysis|Mixed model analyses and Type 3 tests of fixed effects using the Kenward-Roger degrees of freedom procedure were used.|The estimation parameter (mean difference) is the difference in mean change from baseline (post-intervention - baseline) between groups (0.5 gm ginger - placebo). Negative values are favorable for the ginger group.|"H0: Mean difference between 0.5g and placebo of change from baseline of Average Acute Nausea = 0.~Ha: Mean difference between 0.5g and placebo of change from baseline of Average Acute Nausea \> 0. (Two-sided)"||||0.046
72328760|NCT00040742|144182178|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.402|STANDARD_ERROR_OF_MEAN|0.124||0.076|TWO_SIDED|||||The p-value was adjusted using theTukey-Kramer method.|Mixed Models Analysis|Mixed model analyses and Type 3 tests of fixed effects using the Kenward-Roger degrees of freedom procedure were used.|The estimation parameter (mean difference) is the difference in mean change from baseline (post-intervention - baseline) between groups (1 gm ginger - placebo). Negative values are favorable for the ginger group.|"H0: Mean difference between 1.0g and placebo of change from baseline of Average Acute Nausea = 0.~Ha: Mean difference between 1.0g and placebo of change from baseline of Average Acute Nausea \> 0. (Two-sided)"||||0.076
72328761|NCT00040742|144182178|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.158|STANDARD_ERROR_OF_MEAN|0.12||0.738|TWO_SIDED|||||The p-value was adjusted using theTukey-Kramer method.|Mixed Models Analysis|Mixed model analyses and Type 3 tests of fixed effects using the Kenward-Roger degrees of freedom procedure were used.|The estimation parameter (mean difference) is the difference in mean change from baseline (post-intervention - baseline) between groups (1.5 gm ginger - placebo). Negative values are favorable for the ginger group.|"H0: Mean difference between 1.5g and placebo of change from baseline of Average Acute Nausea = 0.~Ha: Mean difference between 1.5g and placebo of change from baseline of Average Acute Nausea \> 0. (Two-sided)"||||0.738
72328762|NCT00040742|144182178|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.35|STANDARD_ERROR_OF_MEAN|0.14||0.013|TWO_SIDED||||||Mixed Models Analysis|Contrasts used for estimation.|The estimation parameter (mean difference) is the difference in mean change from baseline (post-intervention - baseline) between groups (any ginger - placebo). Negative values are favorable for the ginger group.|"Placebo vs Any Ginger. H0: Mean difference between \[(0.5g +1.0g +1.5g) / 3\] and placebo of change from baseline of Average Acute Nausea = 0.~Ha: Mean difference between \[(0.5g +1.0g +1.5g) / 3\] and placebo of change from baseline of Average Acute Nausea \> 0. (Two-sided)"||||0.013
72420726|NCT00279201|144352689|SUPERIORITY_OR_OTHER|||||||0.77||95.0||||P-value is for Baseline.|ANOVA|ANOVA with treatment, country, TZD use in model.||||||0.770
72420727|NCT00279201|144352689|SUPERIORITY_OR_OTHER|||||||0.99||95.0||||P-value is for Endpoint.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.990
72420728|NCT00279201|144352689|SUPERIORITY_OR_OTHER|||||||0.552||95.0||||P-value is for Baseline.|ANOVA|ANOVA with treatment, country, TZD use in model.||||||0.552
72420729|NCT00279201|144352689|SUPERIORITY_OR_OTHER|||||||0.271||95.0||||P-value is for Endpoint.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.271
72420730|NCT00279201|144352690|SUPERIORITY_OR_OTHER|||||||0.027||95.0||||P-value is for \<=7.0%.|Fisher Exact|||||||0.027
72420731|NCT00279201|144352690|SUPERIORITY_OR_OTHER|||||||0.021||95.0||||P-value is for \<7.0%.|Fisher Exact|||||||0.021
72420732|NCT00279201|144352690|SUPERIORITY_OR_OTHER|||||||0.799||95.0||||P-value is for \<=6.5%.|Fisher Exact|||||||0.799
72420733|NCT00279201|144352690|SUPERIORITY_OR_OTHER|||||||0.676||95.0||||P-value is for \<=7.0%.|Fisher Exact|||||||0.676
72420734|NCT00279201|144352690|SUPERIORITY_OR_OTHER|||||||1||95.0||||P-value is for \<7.0%.|Fisher Exact|||||||1.000
72420735|NCT00279201|144352690|SUPERIORITY_OR_OTHER|||||||1||95.0||||P-value is for \<=6.5%.|Fisher Exact|||||||1.000
72420736|NCT00279201|144352691|SUPERIORITY_OR_OTHER|||||||0.241||95.0||||P-value is for Mean fast blood glucose (BG).|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.241
72420737|NCT00279201|144352691|SUPERIORITY_OR_OTHER|||||||0.305||95.0||||P-value is for AM 2-hour postprandial (PP) BG.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.305
72420738|NCT00279201|144352691|SUPERIORITY_OR_OTHER|||||||0.842||95.0||||P-value is for Midday premeal blood glucose.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.842
72328763|NCT00405392|144182201|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Chi-squared|||||||<0.0001
72328764|NCT00405392|144182202|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Chi-squared|||||||<0.0001
72328765|NCT00405392|144182203|SUPERIORITY_OR_OTHER|||||||0.9456|||||||t-test, 2 sided|||||||0.9456
72420739|NCT00279201|144352691|SUPERIORITY_OR_OTHER|||||||0.917||95.0||||P-value is for Midday 2-hour (hr) PP BG.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.917
72420740|NCT00279201|144352691|SUPERIORITY_OR_OTHER|||||||0.648||95.0||||P-value is for PM premeal blood glucose.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.648
72420741|NCT00279201|144352691|SUPERIORITY_OR_OTHER|||||||0.613||95.0||||P-value is for PM 2-hour postprandial BG.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.613
72420742|NCT00279201|144352691|SUPERIORITY_OR_OTHER|||||||0.813||95.0||||P-value is for 3 AM blood glucose.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.813
72420743|NCT00279201|144352691|SUPERIORITY_OR_OTHER|||||||0.953||95.0||||P-value is for AM 2-hour BG excursion.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.953
72420744|NCT00279201|144352691|SUPERIORITY_OR_OTHER|||||||0.933||95.0||||P-value is for Midday 2-hour BG excursion.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.933
72328766|NCT00412958|144182204|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.24||||0.796|TWO_SIDED|95.0|0.24|6.36|||Regression, Logistic|||P-values are from Wald chi-square tests from a logistic regression model with study center and treatment as categorical fixed effects comparing active treatment groups with the placebo group as the reference group.||6.36|0.24|0.796
72420745|NCT00279201|144352691|SUPERIORITY_OR_OTHER|||||||0.348||95.0||||P-value is for PM 2-hour BG excursion.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.348
72420746|NCT00279201|144352691|SUPERIORITY_OR_OTHER|||||||0.625||95.0||||P-value is for Mean all mealtime excursions.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.625
72420747|NCT00279201|144352691|SUPERIORITY_OR_OTHER|||||||0.573||95.0||||P-value is for Mean all 2-hour PP BG.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.573
72420748|NCT00279201|144352691|SUPERIORITY_OR_OTHER|||||||0.711||95.0||||P-value is for Mean all premeal blood glucose.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.711
72420749|NCT00279201|144352691|SUPERIORITY_OR_OTHER|||||||0.372||95.0||||P-value is for Mean combined AM/PM 2hr PP BG.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.372
72420750|NCT00279201|144352691|SUPERIORITY_OR_OTHER|||||||0.516||95.0||||P-value is for Mean AM/PM 2hr BG excursion.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.516
72420751|NCT00279201|144352691|SUPERIORITY_OR_OTHER|||||||0.639||95.0||||P-value is for Mean all BG values.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.639
72420752|NCT00279201|144352691|SUPERIORITY_OR_OTHER|||||||0.131||95.0||||P-value is for Mean fast blood glucose (BG).|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.131
72420753|NCT00279201|144352691|SUPERIORITY_OR_OTHER|||||||0.53||95.0||||P-value is for AM 2-hour postprandial (PP) BG.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.530
72420754|NCT00279201|144352691|SUPERIORITY_OR_OTHER|||||||0.578||95.0||||P-value is for Midday premeal blood glucose.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.578
72420755|NCT00279201|144352691|SUPERIORITY_OR_OTHER|||||||0.004||95.0||||P-value is for Midday 2-hour (hr) PP BG.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.004
72420756|NCT00279201|144352691|SUPERIORITY_OR_OTHER|||||||0.951||95.0||||P-value is for PM premeal blood glucose.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.951
72420757|NCT00279201|144352691|SUPERIORITY_OR_OTHER|||||||0.58||95.0||||P-value is for PM 2-hour postprandial BG.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.580
72420758|NCT00279201|144352691|SUPERIORITY_OR_OTHER|||||||0.071||95.0||||P-value is for 3 AM blood glucose.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.071
72420759|NCT00279201|144352691|SUPERIORITY_OR_OTHER|||||||0.081||95.0||||P-value is for AM 2-hour BG excursion.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.081
72420760|NCT00279201|144352691|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Midday 2-hour BG excursion.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||<0.001
72420761|NCT00279201|144352691|SUPERIORITY_OR_OTHER|||||||0.542||95.0||||P-value is for PM 2-hour BG excursion.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.542
72420762|NCT00279201|144352691|SUPERIORITY_OR_OTHER|||||||0.003||95.0||||P-value is for Mean all mealtime excursions.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.003
72420763|NCT00279201|144352691|SUPERIORITY_OR_OTHER|||||||0.105||95.0||||P-value is for Mean all 2-hour PP BG.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.105
72420764|NCT00279201|144352691|SUPERIORITY_OR_OTHER|||||||0.487||95.0||||P-value is for Mean all premeal blood glucose.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.487
72328767|NCT00412958|144182204|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.81||||0.447|TWO_SIDED|95.0|0.39|8.36|||Regression, Logistic|||P-values are from Wald chi-square test from a logistic regression model with study center and treatment as categorical fixed effects comparing active treatment groups with the placebo group as the reference group.||8.36|0.39|0.447
72328768|NCT00412958|144182204|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.28||||0.107|TWO_SIDED|95.0|0.77|13.95|||Regression, Logistic|||P-values are from Wald chi-square test from a logistic regression model with study center and treatment as categorical fixed effects comparing active treatment groups with the placebo group as the reference group.||13.95|0.77|0.107
72328769|NCT04904744|144182210|SUPERIORITY||Odds Ratio (OR)|1.35||||0.165|TWO_SIDED|95.0|0.88|2.06|||Regression, Logistic||Low Tailored Message vs. No Message (reference group)|||2.06|0.88|0.165
72328770|NCT04904744|144182210|SUPERIORITY||Odds Ratio (OR)|1.33||||0.193|TWO_SIDED|95.0|0.87|2.03|||Regression, Logistic||Low tailored message plus COVID-19 vaccine message vs. No Message|||2.03|0.87|0.193
72328771|NCT04904744|144182210|SUPERIORITY||Odds Ratio (OR)|1.02||||0.93|TWO_SIDED|95.0|0.68|1.52|||Regression, Logistic||Low Tailored Message vs. Low tailored message plus COVID-19 vaccine message|||1.52|0.68|0.930
72328772|NCT04904744|144182211|SUPERIORITY||Odds Ratio (OR)|2.07||||0.008|TWO_SIDED|95.0|1.21|3.52|||Regression, Logistic||Low Tailored Message vs. No Message|||3.52|1.21|0.008
72328773|NCT04904744|144182211|SUPERIORITY||Odds Ratio (OR)|1.25||||0.457|TWO_SIDED|95.0|0.7|2.23|||Regression, Logistic||Low tailored message plus COVID-19 vaccine message vs. No Message|||2.23|0.70|0.457
72328774|NCT04904744|144182211|SUPERIORITY||Odds Ratio (OR)|1.66||||0.049|TWO_SIDED|95.0|1.0|2.74|||Regression, Logistic||Low Tailored Message vs. Low tailored message plus COVID-19 vaccine message|||2.74|1.00|0.049
72328775|NCT04904744|144182212|SUPERIORITY||Odds Ratio (OR)|2.04||||0.104|TWO_SIDED|95.0|0.86|4.82|||Regression, Logistic||Low Tailored Message vs. No Message|||4.82|0.86|0.104
72328776|NCT04904744|144182212|SUPERIORITY||Odds Ratio (OR)|1.26||||0.631|TWO_SIDED|95.0|0.49|3.22|||Regression, Logistic||Low tailored message plus COVID-19 vaccine message vs. No Message|||3.22|0.49|0.631
72328777|NCT04904744|144182212|SUPERIORITY||Odds Ratio (OR)|1.62||||0.238|TWO_SIDED|95.0|0.73|3.61|||Regression, Logistic||Low Tailored Message vs. Low tailored message plus COVID-19 vaccine message|||3.61|0.73|0.238
72328778|NCT01434654|144182217|SUPERIORITY_OR_OTHER|||||||0.99||||||P-value for arm\*time interaction fixed effect.|Mixed Models Analysis|49 datapoints included from baseline, 6 months, and 12 months visits (low CNS penetrance n=14; high CNS penetrance n=35)||The primary outcome was analysed using a mixed-effect regression model with arm and time as fixed linear effects, arm\*time interaction as a non-linear fixed effect and participant as a random effect to account for participant attrition.||||0.99
72328779|NCT01434654|144182218|SUPERIORITY_OR_OTHER|||||||0.58|||||||ANOVA|||Change in NAA/H20 levels was analysed using repeated-measures ANOVA with arm, time, and arm\*time interaction as fixed effects.||||0.58
72328780|NCT01434654|144182218|SUPERIORITY_OR_OTHER|||||||0.44|||||||ANOVA|||Change in Cr/H20 levels was analysed using repeated-measures ANOVA with arm, time, and arm\*time interaction as fixed effects.||||0.44
72328781|NCT01434654|144182218|SUPERIORITY_OR_OTHER|||||||0.86|||||||ANOVA|||Change in Cho/H20 levels was analysed using repeated-measures ANOVA with arm, time, and arm\*time interaction as fixed effects.||||0.86
72328782|NCT01434654|144182218|SUPERIORITY_OR_OTHER|||||||0.98|||||||ANOVA|||Change in mIo/H20 levels was analysed using repeated-measures ANOVA with arm, time, and arm\*time interaction as fixed effects.||||0.98
72328783|NCT01434654|144182219|SUPERIORITY_OR_OTHER|||||||0.16|||||||ANOVA|||Change in NAA/H20 levels were analysed using repeated-measures ANOVA with arm, time, and arm\*time interaction as fixed effects.||||0.16
72328784|NCT01434654|144182219|SUPERIORITY_OR_OTHER|||||||0.09|||||||ANOVA|||Change in Cr/H20 levels were analysed using repeated-measures ANOVA with arm, time, and arm\*time interaction as fixed effects.||||0.09
72328785|NCT01434654|144182219|SUPERIORITY_OR_OTHER|||||||0.06|||||||ANOVA|||Change in Cho/H20 levels were analysed using repeated-measures ANOVA with arm, time, and arm\*time interaction as fixed effects.||||0.06
72328786|NCT01434654|144182219|SUPERIORITY_OR_OTHER|||||||0.68|||||||ANOVA|||Change in mIo/H20 levels were analysed using repeated-measures ANOVA with arm, time, and arm\*time interaction as fixed effects.||||0.68
72328787|NCT01434654|144182219|SUPERIORITY_OR_OTHER|||||||0.58|||||||ANOVA|||Change in Glx/H20 levels were analysed using repeated-measures ANOVA with arm, time, and arm\*time interaction as fixed effects.||||0.58
72328788|NCT01277822|144182233|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority margin was 3 mmHg as Korean Food and Drug Administration (KFDA) guidance.|Mean Difference (Final Values)|-1.3|STANDARD_DEVIATION|7.7||0.1339|TWO_SIDED|95.0|-3.0|0.4|||t-test, 2 sided|Last observed non-missing, post-baseline value was imputed for missing value. If no such value existed, the value was treated as missing in analysis||||0.4|-3.0|0.1339
72328789|NCT01277822|144182234|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4478||||||No imputation for missing data was performed|t-test, 2 sided|||||||0.4478
72328790|NCT01277822|144182235|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0717|||||||t-test, 2 sided|Last observed non-missing, post-baseline value was imputed for missing value. If no such value existed, the value was treated as missing in analysis||||||0.0717
72328791|NCT01277822|144182236|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8736|||||||t-test, 2 sided|No imputation for missing data was performed||||||0.8736
72328792|NCT01277822|144182237|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2508||||||No imputation for missing data was performed|Chi-squared|||||||0.2508
72328793|NCT01277822|144182238|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2508||||||No imputation for missing data was performed|Chi-squared|||||||0.2508
72328794|NCT01277822|144182239|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6646|||||||Chi-squared|||||||0.6646
72328795|NCT01277822|144182240|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7911||||||Left ankle: Last observed non-missing, post-baseline value was imputed for missing value. If no such value existed, the value was treated as missing in analysis|t-test, 2 sided|||||||0.7911
72420765|NCT00279201|144352691|SUPERIORITY_OR_OTHER|||||||0.491||95.0||||P-value is for Mean combined AM/PM 2hr PP BG.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.491
72420766|NCT00279201|144352691|SUPERIORITY_OR_OTHER|||||||0.127||95.0||||P-value is for Mean AM/PM 2hr BG excursion.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.127
72420767|NCT00279201|144352691|SUPERIORITY_OR_OTHER|||||||0.861||95.0||||P-value is for Mean all BG values.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.861
72420768|NCT00279201|144352692|SUPERIORITY_OR_OTHER|||||||0.745||95.0||||P-value is for Baseline.|ANOVA|ANOVA with treatment, country, TZD use in model.||||||0.745
72420769|NCT00279201|144352692|SUPERIORITY_OR_OTHER|||||||0.467||95.0||||P-value is for Baseline.|ANOVA|ANOVA with treatment, country, TZD use in model.||||||0.467
72420770|NCT00279201|144352692|SUPERIORITY_OR_OTHER|||||||0.575||95.0||||P-value is for Week 6.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.575
72420771|NCT00279201|144352692|SUPERIORITY_OR_OTHER|||||||0.726||95.0||||P-value is for Week 12.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.726
72420772|NCT00279201|144352692|SUPERIORITY_OR_OTHER|||||||0.978||95.0||||P-value is for Week 24.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.978
72420773|NCT00279201|144352692|SUPERIORITY_OR_OTHER|||||||0.345||95.0||||P-value is for Endpoint.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.345
72420774|NCT00279201|144352692|SUPERIORITY_OR_OTHER|||||||0.166||95.0||||P-value is for Week 6.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.166
72420775|NCT00279201|144352692|SUPERIORITY_OR_OTHER|||||||0.064||95.0||||P-value is for Week 12.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.064
72420776|NCT00279201|144352692|SUPERIORITY_OR_OTHER|||||||0.199||95.0||||P-value is for Week 24.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.199
72420777|NCT00279201|144352692|SUPERIORITY_OR_OTHER|||||||0.098||95.0||||P-value is for Endpoint.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.098
72420778|NCT00279201|144352693|SUPERIORITY_OR_OTHER|||||||0.467||95.0||||P-value is for Baseline.|ANOVA|ANOVA with treatment, country, and TZD use in model.||||||0.467
72420779|NCT00279201|144352693|SUPERIORITY_OR_OTHER|||||||0.575||95.0||||P-value is for Week 6.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.575
72420780|NCT00279201|144352693|SUPERIORITY_OR_OTHER|||||||0.726||95.0||||P-value is for Week 12.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.726
72420781|NCT00279201|144352693|SUPERIORITY_OR_OTHER|||||||0.978||95.0||||P-value is for Week 24.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.978
72420782|NCT00279201|144352693|SUPERIORITY_OR_OTHER|||||||0.345||95.0||||P-value is for Endpoint.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.345
72420783|NCT00279201|144352693|SUPERIORITY_OR_OTHER|||||||0.745||95.0||||P-value is for Baseline.|ANOVA|ANOVA with treatment, country, and TZD use in model.||||||0.745
72420784|NCT00279201|144352693|SUPERIORITY_OR_OTHER|||||||0.166||95.0||||P-value is for Week 6.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.166
72420785|NCT00279201|144352693|SUPERIORITY_OR_OTHER|||||||0.064||95.0||||P-value is for Week 12.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.064
72420786|NCT00279201|144352693|SUPERIORITY_OR_OTHER|||||||0.199||95.0||||P-value is for Week 24.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.199
72420787|NCT00279201|144352693|SUPERIORITY_OR_OTHER|||||||0.098||95.0||||P-value is for Endpoint.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.098
72420788|NCT00279201|144352694|SUPERIORITY_OR_OTHER|||||||0.837||95.0||||P-value is for Week 1.|ANOVA|ANOVA with treatment, country, TZD use in the model.||||||0.837
72420789|NCT00279201|144352694|SUPERIORITY_OR_OTHER|||||||0.205||95.0||||P-value is for Week 2.|ANOVA|ANOVA with treatment, country, TZD use in the model.||||||0.205
72420790|NCT00279201|144352694|SUPERIORITY_OR_OTHER|||||||0.704||95.0||||P-value is for Week 3.|ANOVA|ANOVA with treatment, country, TZD use in the model.||||||0.704
72420791|NCT00279201|144352694|SUPERIORITY_OR_OTHER|||||||0.61||95.0||||P-value is for Week 4.|ANOVA|ANOVA with treatment, country, TZD use in the model.||||||0.610
72420792|NCT00279201|144352694|SUPERIORITY_OR_OTHER|||||||0.352||95.0||||P-value is for Week 5.|ANOVA|ANOVA with treatment, country, TZD use in the model.||||||0.352
72420793|NCT00279201|144352694|SUPERIORITY_OR_OTHER|||||||0.636||95.0||||P-value is for Week 6.|ANOVA|ANOVA with treatment, country, TZD use in the model.||||||0.636
72420794|NCT00279201|144352694|SUPERIORITY_OR_OTHER|||||||0.88||95.0||||P-value is for Week 8.|ANOVA|ANOVA with treatment, country, TZD use in the model.||||||0.880
72420795|NCT00279201|144352694|SUPERIORITY_OR_OTHER|||||||0.904||95.0||||P-value is for Week 10.|ANOVA|ANOVA with treatment, country, TZD use in the model.||||||0.904
72420796|NCT00279201|144352694|SUPERIORITY_OR_OTHER|||||||0.859||95.0||||P-value is for Week 12.|ANOVA|ANOVA with treatment, country, TZD use in the model.||||||0.859
72420797|NCT00279201|144352694|SUPERIORITY_OR_OTHER|||||||0.654||95.0||||P-value is for Week 24.|ANOVA|ANOVA with treatment, country, TZD use in the model.||||||0.654
72420798|NCT00279201|144352694|SUPERIORITY_OR_OTHER|||||||0.566||95.0||||P-value is for Endpoint.|ANOVA|ANOVA with treatment, country, TZD use in the model.||||||0.566
72420799|NCT00279201|144352694|SUPERIORITY_OR_OTHER|||||||0.926||95.0||||P-value is for Week 1.|ANOVA|ANOVA with treatment, country, TZD use in the model.||||||0.926
72420800|NCT00279201|144352694|SUPERIORITY_OR_OTHER|||||||0.902||95.0||||P-value is for Week 2.|ANOVA|ANOVA with treatment, country, TZD use in the model.||||||0.902
72420801|NCT00279201|144352694|SUPERIORITY_OR_OTHER|||||||0.766||95.0||||P-value is for Week 3.|ANOVA|ANOVA with treatment, country, TZD use in the model.||||||0.766
72420802|NCT00279201|144352694|SUPERIORITY_OR_OTHER|||||||0.449||95.0||||P-value is for Week 4.|ANOVA|ANOVA with treatment, country, TZD use in the model.||||||0.449
72420803|NCT00279201|144352694|SUPERIORITY_OR_OTHER|||||||0.797||95.0||||P-value is for Week 5.|ANOVA|ANOVA with treatment, country, TZD use in the model.||||||0.797
72420804|NCT00279201|144352694|SUPERIORITY_OR_OTHER|||||||0.438||95.0||||P-value is for Week 6.|ANOVA|ANOVA with treatment, country, TZD use in the model.||||||0.438
72420805|NCT00279201|144352694|SUPERIORITY_OR_OTHER|||||||0.602||95.0||||P-value is for Week 8.|ANOVA|ANOVA with treatment, country, TZD use in the model.||||||0.602
72420806|NCT00279201|144352694|SUPERIORITY_OR_OTHER|||||||0.493||95.0||||P-value is for Week 10.|ANOVA|ANOVA with treatment, country, TZD use in the model.||||||0.493
72420807|NCT00279201|144352694|SUPERIORITY_OR_OTHER|||||||0.335||95.0||||P-value is for Week 12.|ANOVA|ANOVA with treatment, country, TZD use in the model.||||||0.335
72420808|NCT00279201|144352694|SUPERIORITY_OR_OTHER|||||||0.398||95.0||||P-value is for Week 24.|ANOVA|ANOVA with treatment, country, TZD use in the model.||||||0.398
72420809|NCT00279201|144352694|SUPERIORITY_OR_OTHER|||||||0.903||95.0||||P-value is for Endpoint.|ANOVA|ANOVA with treatment, country, TZD use in the model.||||||0.903
72420810|NCT00279201|144352695|SUPERIORITY_OR_OTHER|||||||0.953||95.0||||P-value is for Hypoglycemia episodes endpoint.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel statistic controlling for country and TZD use.||||||0.953
72328796|NCT01277822|144182240|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5933||||||Right ankle: Last observed non-missing, post-baseline value was imputed for missing value. If no such value existed, the value was treated as missing in analysis|t-test, 2 sided|||||||0.5933
72328797|NCT03012828|144182241|OTHER|The model was used for predicting population average and 90% 2-sided bootstrapped CI of the baseline-adjusted difference between active and placebo at each time point bound at clinically relevant concentrations.|Slope|-0.0077||||0.4727|TWO_SIDED|90.0|-0.0255|0.0101|||Mixed Models Analysis||The primary mixed effects model analysis revealed a nearly flat dQTcF - plasma concentration gradient|The primary analysis used a mixed-effects model to explore the relationship between the time-matched, baseline-adjusted QTcF (delta (d)QTcF) and moxidectin concentrations. dQTcF was a dependent variable and treatment, time point, and treatment by time point interaction as the independent variables with baseline QTcF as a covariate and time-matched concentrations of moxidectin as a covariate with random effects of intercept and slope for each subject.Concentrations of zero were used for placebo.||0.0101|-0.0255|0.4727
72328798|NCT04855240|144182267|SUPERIORITY||LSM difference|-10.5|STANDARD_ERROR_OF_MEAN|7.61||0.1683|TWO_SIDED|95.0|-25.4|4.4|||ANOVA|||||4.4|-25.4|0.1683
72328799|NCT04855240|144182267|SUPERIORITY||LSM difference|1.6|STANDARD_ERROR_OF_MEAN|7.64||0.8356|TWO_SIDED|95.0|-13.4|16.6|||ANOVA|||||16.6|-13.4|0.8356
72328800|NCT04855240|144182268|SUPERIORITY||Hazard Ratio (HR)|0.831||||0.228|TWO_SIDED|95.0|0.598|1.155|||Log Rank|||||1.155|0.598|0.2280
72328801|NCT04855240|144182268|SUPERIORITY||Hazard Ratio (HR)|1.1||||0.5604|TWO_SIDED|95.0|0.793|1.527|||Log Rank|||||1.527|0.793|0.5604
72328802|NCT04855240|144182269|SUPERIORITY||Risk Difference (RD)|0.11||||0.2457|TWO_SIDED|95.0|-0.05|0.26|||Cochran-Mantel-Haenszel|||||0.26|-0.05|0.2457
72328803|NCT04855240|144182269|SUPERIORITY||Risk Difference (RD)|-0.06||||0.3997|TWO_SIDED|95.0|-0.22|0.09|||Cochran-Mantel-Haenszel|||||0.09|-0.22|0.3997
72328804|NCT04855240|144182270|SUPERIORITY||Risk Difference (RD)|0.07||||0.4771|TWO_SIDED|95.0|-0.09|0.22|||Cochran-Mantel-Haenszel|||||0.22|-0.09|0.4771
72328805|NCT04855240|144182270|SUPERIORITY||Risk Difference (RD)|-0.09||||0.2925|TWO_SIDED|95.0|-0.24|0.06|||Cochran-Mantel-Haenszel|||||0.06|-0.24|0.2925
72420811|NCT00279201|144352695|SUPERIORITY_OR_OTHER|||||||0.953||95.0||||P-value is for Overall hypoglycemia episodes.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel statistic controlling for country and TZD use.||||||0.953
72420812|NCT00279201|144352695|SUPERIORITY_OR_OTHER|||||||0.188||95.0||||P-value is for Severe episodes overall.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel statistic controlling for country and TZD use.||||||0.188
72328806|NCT04855240|144182271|SUPERIORITY||Risk Difference (RD)|0.07||||0.4628|TWO_SIDED|95.0|-0.09|0.22|||Cochran-Mantel-Haenszel|||||0.22|-0.09|0.4628
72328807|NCT04855240|144182271|SUPERIORITY||Risk Difference (RD)|-0.09||||0.309|TWO_SIDED|95.0|-0.24|0.06|||Cochran-Mantel-Haenszel|||||0.06|-0.24|0.3090
72328808|NCT04855240|144182272|SUPERIORITY||LSM difference|-17.7|STANDARD_ERROR_OF_MEAN|15.36||0.2494|TWO_SIDED|95.0|-47.8|12.4|||ANOVA|||||12.4|-47.8|0.2494
72328809|NCT04855240|144182272|SUPERIORITY||LSM difference|5.1|STANDARD_ERROR_OF_MEAN|15.42||0.7385|TWO_SIDED|95.0|-25.1|35.4|||ANOVA|||||35.4|-25.1|0.7385
72328810|NCT04855240|144182273|SUPERIORITY||LSM difference|-22.6|STANDARD_ERROR_OF_MEAN|22.91||0.3238|TWO_SIDED|95.0|-67.5|22.3|||ANOVA|||||22.3|-67.5|0.3238
72328811|NCT04855240|144182273|SUPERIORITY||LSM difference|7.8|STANDARD_ERROR_OF_MEAN|22.99||0.7344|TWO_SIDED|95.0|-37.3|52.9|||ANOVA|||||52.9|-37.3|0.7344
72328812|NCT04855240|144182274|SUPERIORITY||LSM difference|-0.3|STANDARD_ERROR_OF_MEAN|1.72||0.8489|TWO_SIDED|95.0|-3.7|3.0|||ANOVA|||||3.0|-3.7|0.8489
72328813|NCT04855240|144182274|SUPERIORITY||LSM difference|1.9|STANDARD_ERROR_OF_MEAN|1.72||0.2768|TWO_SIDED|95.0|-1.5|5.3|||ANOVA|||||5.3|-1.5|0.2768
72420813|NCT00279201|144352695|SUPERIORITY_OR_OTHER|||||||0.226||95.0||||P-value is for Nocturnal episodes endpoint.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel statistic controlling for country and TZD use.||||||0.226
72420814|NCT00279201|144352695|SUPERIORITY_OR_OTHER|||||||0.855||95.0||||P-value is for Nocturnal episodes overall.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel statistic controlling for country and TZD use.||||||0.855
72420815|NCT00279201|144352695|SUPERIORITY_OR_OTHER|||||||0.25||95.0||||P-value is for Hypoglycemia episodes at endpoint.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel statistic controlling for country and TZD use.||||||0.250
72420816|NCT00279201|144352695|SUPERIORITY_OR_OTHER|||||||0.123||95.0||||P-value is for Overall hypoglycemia episodes.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel statistic controlling for country and TZD use.||||||0.123
72328814|NCT04855240|144182275|SUPERIORITY||LSM difference|-1.2|STANDARD_ERROR_OF_MEAN|2.54||0.6291|TWO_SIDED|95.0|-6.2|3.8|||ANOVA|||||3.8|-6.2|0.6291
72328815|NCT04855240|144182275|SUPERIORITY||LSM difference|2.5|STANDARD_ERROR_OF_MEAN|2.55||0.3182|TWO_SIDED|95.0|-2.5|7.5|||ANOVA|||||7.5|-2.5|0.3182
72328816|NCT04855240|144182276|SUPERIORITY||LSM difference|-4.2|STANDARD_ERROR_OF_MEAN|4.35||0.3299|TWO_SIDED|95.0|-12.8|4.3|||ANOVA|||||4.3|-12.8|0.3299
72328817|NCT04855240|144182276|SUPERIORITY||LSM difference|0.6|STANDARD_ERROR_OF_MEAN|4.37||0.8822|TWO_SIDED|95.0|-7.9|9.2|||ANOVA|||||9.2|-7.9|0.8822
72328818|NCT04855240|144182277|SUPERIORITY||LSM difference|-7.1|STANDARD_ERROR_OF_MEAN|8.62||0.4094|TWO_SIDED|95.0|-24.0|9.8|||ANOVA|||||9.8|-24.0|0.4094
72328819|NCT04855240|144182277|SUPERIORITY||LSM difference|3.4|STANDARD_ERROR_OF_MEAN|8.65||0.6901|TWO_SIDED|95.0|-13.5|20.4|||ANOVA|||||20.4|-13.5|0.6901
72328820|NCT04855240|144182278|SUPERIORITY||LSM difference|-5.1|STANDARD_ERROR_OF_MEAN|8.59||0.5536|TWO_SIDED|95.0|-21.9|11.7|||ANOVA|||||11.7|-21.9|0.5536
72328821|NCT04855240|144182278|SUPERIORITY||LSM difference|2.4|STANDARD_ERROR_OF_MEAN|8.64||0.7811|TWO_SIDED|95.0|-14.5|19.3|||ANOVA|||||19.3|-14.5|0.7811
72328822|NCT04855240|144182279|SUPERIORITY||LSM difference|-0.2|STANDARD_ERROR_OF_MEAN|0.29||0.5267|TWO_SIDED|95.0|-0.8|0.4|||ANOVA|||||0.4|-0.8|0.5267
72328823|NCT04855240|144182279|SUPERIORITY||LSM difference|0.3|STANDARD_ERROR_OF_MEAN|0.29||0.3228|TWO_SIDED|95.0|-0.3|0.9|||ANOVA|||||0.9|-0.3|0.3228
72328824|NCT04855240|144182280|SUPERIORITY||LSM difference|-0.1|STANDARD_ERROR_OF_MEAN|0.24||0.7617|TWO_SIDED|95.0|-0.5|0.4|||ANOVA|||||0.4|-0.5|0.7617
72328825|NCT04855240|144182280|SUPERIORITY||LSM difference|0.1|STANDARD_ERROR_OF_MEAN|0.24||0.6241|TWO_SIDED|95.0|-0.4|0.6|||ANOVA|||||0.6|-0.4|0.6241
72328826|NCT04855240|144182281|SUPERIORITY||LSM difference|-0.2|STANDARD_ERROR_OF_MEAN|0.17||0.3442|TWO_SIDED|95.0|-0.5|0.2|||ANOVA|||||0.2|-0.5|0.3442
72328827|NCT04855240|144182281|SUPERIORITY||LSM difference|0.0|STANDARD_ERROR_OF_MEAN|0.17||0.7896|TWO_SIDED|95.0|-0.3|0.4|||ANOVA|||||0.4|-0.3|0.7896
72328828|NCT04855240|144182282|SUPERIORITY||LSM difference|-0.3|STANDARD_ERROR_OF_MEAN|0.49||0.6003|TWO_SIDED|95.0|-1.2|0.7|||ANOVA|||||0.7|-1.2|0.6003
72328829|NCT04855240|144182282|SUPERIORITY||LSM difference|0.4|STANDARD_ERROR_OF_MEAN|0.49||0.4086|TWO_SIDED|95.0|-0.6|1.4|||ANOVA|||||1.4|-0.6|0.4086
72328830|NCT04855240|144182283|SUPERIORITY||LSM difference|-0.4|STANDARD_ERROR_OF_MEAN|0.61||0.4958|TWO_SIDED|95.0|-1.6|0.8|||ANOVA|||||0.8|-1.6|0.4958
72328831|NCT04855240|144182283|SUPERIORITY||LSM difference|0.5|STANDARD_ERROR_OF_MEAN|0.61||0.4595|TWO_SIDED|95.0|-0.8|1.7|||ANOVA|||||1.7|-0.8|0.4595
72328832|NCT04855240|144182284|SUPERIORITY||Risk Difference (RD)|0.08||||0.1686|TWO_SIDED|95.0|-0.04|0.19|||Cochran-Mantel-Haenszel|||||0.19|-0.04|0.1686
72328833|NCT04855240|144182284|SUPERIORITY||Risk Difference (RD)|0.0||||0.8333|TWO_SIDED|95.0|-0.1|0.11|||Cochran-Mantel-Haenszel|||||0.11|-0.10|0.8333
72328834|NCT04855240|144182285|SUPERIORITY||Risk Difference (RD)|0.09||||0.1939|TWO_SIDED|95.0|-0.02|0.2|||Cochran-Mantel-Haenszel|||||0.20|-0.02|0.1939
72328835|NCT04855240|144182285|SUPERIORITY||Risk Difference (RD)|0.0||||0.9595|TWO_SIDED|95.0|-0.1|0.1|||Cochran-Mantel-Haenszel|||||0.10|-0.10|0.9595
72328836|NCT04855240|144182286|SUPERIORITY||Risk Difference (RD)|0.09||||0.1894|TWO_SIDED|95.0|-0.02|0.2|||Cochran-Mantel-Haenszel|||||0.20|-0.02|0.1894
72328837|NCT04855240|144182286|SUPERIORITY||Risk Difference (RD)|0.0||||0.9595|TWO_SIDED|95.0|-0.1|0.1|||Cochran-Mantel-Haenszel|||||0.10|-0.10|0.9595
72328838|NCT04855240|144182287|SUPERIORITY||Risk Difference (RD)|0.09||||0.7117|TWO_SIDED|95.0|-0.06|0.24|||Cochran-Mantel-Haenszel|||||0.24|-0.06|0.7117
72328839|NCT04855240|144182287|SUPERIORITY||Risk Difference (RD)|-0.04||||0.7599|TWO_SIDED|95.0|-0.19|0.1|||Cochran-Mantel-Haenszel|||||0.10|-0.19|0.7599
72328840|NCT04855240|144182288|SUPERIORITY||Risk Difference (RD)|0.0||||0.707|TWO_SIDED|95.0|-0.16|0.16|||Cochran-Mantel-Haenszel|||||0.16|-0.16|0.7070
72328841|NCT04855240|144182288|SUPERIORITY||Risk Difference (RD)|-0.04||||0.6877|TWO_SIDED|95.0|-0.2|0.12|||Cochran-Mantel-Haenszel|||||0.12|-0.20|0.6877
72328842|NCT04855240|144182289|SUPERIORITY||Risk Difference (RD)|-0.07||||0.869|TWO_SIDED|95.0|-0.22|0.07|||Cochran-Mantel-Haenszel|||||0.07|-0.22|0.8690
72328843|NCT04855240|144182289|SUPERIORITY||Risk Difference (RD)|-0.04||||0.379|TWO_SIDED|95.0|-0.19|0.1|||Cochran-Mantel-Haenszel|||||0.10|-0.19|0.3790
72328844|NCT04855240|144182290|SUPERIORITY||LSM difference|5.9|STANDARD_ERROR_OF_MEAN|3.49||0.0897|TWO_SIDED|95.0|-0.9|12.8|||ANOVA|||||12.8|-0.9|0.0897
72328845|NCT04855240|144182290|SUPERIORITY||LSM difference|-0.2|STANDARD_ERROR_OF_MEAN|3.5||0.9434|TWO_SIDED|95.0|-7.1|6.7|||ANOVA|||||6.7|-7.1|0.9434
72328846|NCT04855240|144182291|SUPERIORITY||Risk Difference (RD)|0.09||||0.8355|TWO_SIDED|95.0|-0.04|0.21|||Cochran-Mantel-Haenszel|||||0.21|-0.04|0.8355
72328847|NCT04855240|144182291|SUPERIORITY||Risk Difference (RD)|0.02||||0.3561|TWO_SIDED|95.0|-0.12|0.15|||Cochran-Mantel-Haenszel|||||0.15|-0.12|0.3561
72328848|NCT04855240|144182292|SUPERIORITY||Risk Difference (RD)|0.04||||0.9413|TWO_SIDED|95.0|-0.06|0.13|||Cochran-Mantel-Haenszel|||||0.13|-0.06|0.9413
72328849|NCT04855240|144182292|SUPERIORITY||Risk Difference (RD)|-0.04||||0.7819|TWO_SIDED|95.0|-0.15|0.07|||Cochran-Mantel-Haenszel|||||0.07|-0.15|0.7819
72328850|NCT04855240|144182293|SUPERIORITY||LSM difference|0.0|STANDARD_ERROR_OF_MEAN|0.22||0.8461|TWO_SIDED|95.0|-0.5|0.4|||ANOVA|||||0.4|-0.5|0.8461
72328851|NCT04855240|144182293|SUPERIORITY||LSM difference|0.3|STANDARD_ERROR_OF_MEAN|0.22||0.1727|TWO_SIDED|95.0|-0.1|0.7|||ANOVA|||||0.7|-0.1|0.1727
72328852|NCT04855240|144182294|SUPERIORITY||LSM difference|0.0|STANDARD_ERROR_OF_MEAN|0.22||0.9022|TWO_SIDED|95.0|-0.4|0.5|||ANOVA|||||0.5|-0.4|0.9022
72328853|NCT04855240|144182294|SUPERIORITY||LSM difference|0.3|STANDARD_ERROR_OF_MEAN|0.23||0.245|TWO_SIDED|95.0|-0.2|0.7|||ANOVA|||||0.7|-0.2|0.2450
72328854|NCT04855240|144182295|SUPERIORITY||LSM difference|0.2|STANDARD_ERROR_OF_MEAN|0.4205||0.4205|TWO_SIDED|95.0|-0.2|0.6|||ANOVA|||||0.6|-0.2|0.4205
72328855|NCT04855240|144182295|SUPERIORITY||LSM difference|0.2|STANDARD_ERROR_OF_MEAN|0.21||0.4336|TWO_SIDED|95.0|-0.2|0.6|||ANOVA|||||0.6|-0.2|0.4336
72328856|NCT04855240|144182296|SUPERIORITY||LSM difference|0.2|STANDARD_ERROR_OF_MEAN|0.22||0.2718|TWO_SIDED|95.0|-0.2|0.7|||ANOVA|||||0.7|-0.2|0.2718
72328857|NCT04855240|144182296|SUPERIORITY||LSM difference|0.3|STANDARD_ERROR_OF_MEAN|0.22||0.1727|TWO_SIDED|95.0|-0.1|0.7|||ANOVA|||||0.7|-0.1|0.1727
72420817|NCT00279201|144352695|SUPERIORITY_OR_OTHER|||||||0.166||95.0||||P-value is for Severe episodes overall.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel statistic controlling for country and TZD use.||||||0.166
72420818|NCT00279201|144352695|SUPERIORITY_OR_OTHER|||||||0.273||95.0||||P-value is for Nocturnal episodes endpoint.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel statistic controlling for country and TZD use.||||||0.273
72420819|NCT00279201|144352695|SUPERIORITY_OR_OTHER|||||||0.039||95.0||||P-value is for Nocturnal episodes overall.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel statistic controlling for country and TZD use.||||||0.039
72420820|NCT00279201|144352696|SUPERIORITY_OR_OTHER|||||||0.623||95.0||||P-value is for Hypoglycemia episodes Endpoint.|ANOVA|Response = Treatment + Country + TZD use + Sulfo use.||||||0.623
72420821|NCT00279201|144352696|SUPERIORITY_OR_OTHER|||||||0.949||95.0||||P-value is for Hypoglycemic episodes Overall.|ANOVA|Response = Treatment + Country + TZD use + Sulfo use.||||||0.949
72420822|NCT00279201|144352696|SUPERIORITY_OR_OTHER|||||||0.73||95.0||||P-value is for Hypoglycemia episodes Endpoint.|ANOVA|Response = Treatment + Country + TZD use + Sulfo use.||||||0.730
72420823|NCT00279201|144352696|SUPERIORITY_OR_OTHER|||||||0.445||95.0||||P-value is for Hypoglycemia episodes Overall.|ANOVA|Response = Treatment + Country + TZD use + Sulfo use.||||||0.445
72420824|NCT00279201|144352696|SUPERIORITY_OR_OTHER|||||||0.949||95.0||||P-value is for Nocturnal episodes Endpoint.|ANOVA|Response = Treatment + Country + TZD use + Sulfo use.||||||0.949
72420825|NCT00279201|144352696|SUPERIORITY_OR_OTHER|||||||0.59||95.0||||P-value is for Nocturnal episodes Overall.|ANOVA|Response = Treatment + Country + TZD use + Sulfo use.||||||0.590
72420826|NCT00279201|144352696|SUPERIORITY_OR_OTHER|||||||0.657||95.0||||P-value is for Nocturnal episodes Endpoint.|ANOVA|Response = Treatment + Country + TZD use + Sulfo use.||||||0.657
72420827|NCT00279201|144352696|SUPERIORITY_OR_OTHER|||||||0.108||95.0||||P-value is for Nocturnal episodes Overall.|ANOVA|Response = Treatment + Country + TZD use + Sulfo use.||||||0.108
72420828|NCT00279201|144352696|SUPERIORITY_OR_OTHER|||||||0.161||95.0||||P-value is for Severe episodes Overall.|ANOVA|Response = Treatment + Country + TZD use + Sulfo use.||||||0.161
72420829|NCT00279201|144352696|SUPERIORITY_OR_OTHER|||||||0.178||95.0||||P-value is for Severe episodes Overall.|ANOVA|Response = Treatment + Country + TZD use + Sulfo use.||||||0.178
72420830|NCT00279201|144352697|SUPERIORITY_OR_OTHER|||||||0.917||95.0||||P-value is for Baseline.|ANOVA|ANOVA with treatment, country, TZD use in model.||||||0.917
72420831|NCT00279201|144352697|SUPERIORITY_OR_OTHER|||||||0.754||95.0||||P-value for Baseline.|ANOVA|ANOVA with treatment, country, TZD use in model.||||||0.754
72420832|NCT00279201|144352697|SUPERIORITY_OR_OTHER|||||||0.42||95.0||||P-value is for Change.|ANCOVA|ANCOVA model with treatment, baseline, country, and TZD use.||||||0.420
72420833|NCT00279201|144352697|SUPERIORITY_OR_OTHER|||||||0.514||95.0||||P-value for Change.|ANCOVA|ANCOVA model with treatment, baseline, country, and TZD use.||||||0.514
72420834|NCT00279201|144352698|SUPERIORITY_OR_OTHER|||||||0.77||95.0||||P-value is for Baseline.|ANOVA|ANOVA with treatment, country, TZD use in model.||||||0.770
72420835|NCT00279201|144352698|SUPERIORITY_OR_OTHER|||||||0.566||95.0||||P-value is for Week 12.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.566
72420836|NCT00279201|144352698|SUPERIORITY_OR_OTHER|||||||0.812||95.0||||P-value is for Week 24.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.812
72420837|NCT00279201|144352698|SUPERIORITY_OR_OTHER|||||||0.99||95.0||||P-value is for Endpoint.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.990
72420838|NCT00279201|144352698|SUPERIORITY_OR_OTHER|||||||0.552||95.0||||P-value is for Baseline.|ANOVA|ANOVA with treatment, country, TZD use in model.||||||0.552
72420839|NCT00279201|144352698|SUPERIORITY_OR_OTHER|||||||0.179||95.0||||P-value is for Week 12.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.179
72420840|NCT00279201|144352698|SUPERIORITY_OR_OTHER|||||||0.377||95.0||||P-value is for Week 24.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.377
72420841|NCT00279201|144352698|SUPERIORITY_OR_OTHER|||||||0.271||95.0||||P-value is for Endpoint.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.271
72420842|NCT00316173|144352701|SUPERIORITY_OR_OTHER||Percentage of participants with CR+PR|30.9||||||95.0|18.7|43.1||||||||43.1|18.7|
72420843|NCT00511875|144352720|SUPERIORITY|||||||0.7|||||||t-test, 2 sided|||||||.70
72420844|NCT00511875|144352721|SUPERIORITY|||||||0.33|||||||t-test, 2 sided|||Foveal Sensitivity||||.33
72420845|NCT00511875|144352721|SUPERIORITY|||||||0.16|||||||t-test, 2 sided|||Mean field sensitivity||||.16
72420846|NCT00511875|144352722|SUPERIORITY|||||||0.02|||||||t-test, 2 sided|||Foveal Sensitivity||||.02
72420847|NCT00511875|144352722|SUPERIORITY|||||||0.3|||||||t-test, 2 sided|||mean FDP sensitivity||||.3
72420848|NCT00511875|144352723|SUPERIORITY|||||||0.98|||||||t-test, 2 sided|||||||.98
72420849|NCT00511875|144352724|SUPERIORITY|||||||0.46|||||||t-test, 2 sided|||||||.46
72420850|NCT00511875|144352725|SUPERIORITY|||||||0.81|||||||t-test, 2 sided|||||||.81
72420851|NCT00511875|144352726|SUPERIORITY|||||||0.88|||||||t-test, 2 sided|||||||.88
72420852|NCT00511875|144352727|SUPERIORITY|||||||0.75|||||||t-test, 2 sided|||||||.75
72420853|NCT00511875|144352728|SUPERIORITY|||||||0.62|||||||t-test, 2 sided|||||||.62
72420854|NCT02618616|144352729|OTHER||least square difference|8.7||||0.8495|ONE_SIDED|90.0|8.4|||The 1-sided p-value tests if the ZPL-389 Least square (LS) mean is \< the placebo LS mean.|ANCOVA|||ANCOVA of PASI at Week 12|||8.4|0.8495
72420855|NCT02618616|144352730|OTHER||Odds Ratio (OR)|0.562||||0.9058|TWO_SIDED|90.0|0.27|1.16|||Regression, Logistic|||Logistic Regression PASI-50||1.16|0.27|0.9058
72420856|NCT02618616|144352730|OTHER||Odds Ratio (OR)|0.946||||0.5422|TWO_SIDED|90.0|0.4|2.25|||Regression, Logistic|||Logistic Regression PASI-75||2.25|0.4|0.5422
72420857|NCT01349920|144352749|SUPERIORITY_OR_OTHER|||||||0.071|||||||Multiple Linear Regression|||Week 6||||0.071
72420858|NCT01349920|144352749|SUPERIORITY_OR_OTHER|||||||0.381|||||||Multiple Linear Regression|||Week 22||||0.381
72420859|NCT00696384|144352768|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.78|||<|0.001|TWO_SIDED|95.0|-9.78|-5.78||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Includes participants with both a double-blind baseline and postbaseline value.|ANCOVA|||||-5.78|-9.78|<0.001
72420860|NCT00696384|144352769|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.38|||<|0.001|TWO_SIDED|95.0|-15.47|-9.29||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Includes participants with both a double-blind baseline and postbaseline value.|ANCOVA|||||-9.29|-15.47|<0.001
72420861|NCT05361655|144352831|OTHER||Hazard Ratio (HR)|0.76|||<|0.0001|TWO_SIDED|95.0|0.65|0.87|||Cox proportional hazard model|||||0.87|0.65|<0.0001
72420862|NCT05361655|144352832|OTHER||Hazard Ratio (HR)|0.7|||<|0.0001|TWO_SIDED|95.0|0.62|0.76|||Cox proportional hazards model|||||0.76|0.62|<0.0001
72420863|NCT05361655|144352834|OTHER||||||<|0.0001|||||||score test|||||||<0.0001
72420864|NCT05361655|144352837|OTHER||Hazard Ratio (HR)|0.65|||<|0.0001|TWO_SIDED|95.0|0.6|0.72|||Cox proportional hazard model|||||0.72|0.60|<0.0001
72420865|NCT05361655|144352838|OTHER||Hazard Ratio (HR)|0.56|||<|0.0001|TWO_SIDED|95.0|0.51|0.62|||Cox proportional hazard model|||||0.62|0.51|<0.0001
72420866|NCT05361655|144352839|OTHER||Hazard Ratio (HR)|0.77|||<|0.0001|TWO_SIDED|95.0|0.69|0.86|||Cox proportional hazard model|||||0.86|0.69|<0.0001
72420867|NCT05361655|144352840|OTHER||Hazard Ratio (HR)|0.62|||<|0.0001|TWO_SIDED|95.0|0.54|0.7|||Cox proportional hazards model|||||0.70|0.54|<0.0001
72420868|NCT00811382|144352841|SUPERIORITY|||||||0.97|||||||Wilcoxon (Mann-Whitney)|||||||0.97
72420869|NCT01984697|144352853|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the Geometric Mean Titer (GMT) ratio for Girls 9 to 14 Years / Young Women 16 to 26 years is \>0.67.|GMT ratio|2.15|||<|0.001|TWO_SIDED|95.0|1.83|2.53|||ANOVA|One-sided non-inferiority test at alpha=0.025 level||||2.53|1.83|<0.001
72420870|NCT01984697|144352853|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the GMT ratio for Boys 9 to 14 Years / Young Women 16 to 26 years is \>0.67.|GMT Ratio|2.02|||<|0.001|TWO_SIDED|95.0|1.73|2.36|||ANOVA|One-sided non-inferiority test at alpha=0.025 level||||2.36|1.73|<0.001
72420871|NCT01984697|144352853|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the GMT ratio for Girls and Boys 9 to 14 Years / Young Women 16 to 26 years is \>0.67.|GMT Ratio|3.47|||<|0.001|TWO_SIDED|95.0|2.93|4.11|||ANOVA|One-sided non-inferiority test at alpha=0.025 level||||4.11|2.93|<0.001
72420872|NCT01984697|144352854|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the seroconversion percentage difference for Girls 9 to 14 Years - Young Women 16 to 26 years is \> -5.|Seroconversion percentage difference|0.0|||<|0.001|TWO_SIDED|95.0|-1.8|2.0|||Miettinen and Nurminen|One-sided non-inferiority test at alpha=0.025 level||||2.0|-1.8|<0.001
72420873|NCT01984697|144352854|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the seroconversion percentage difference for Boys 9 to 14 Years - Young Women 16 to 26 years is \> -5.|Seroconversion percentage difference|0.4|||<|0.001|TWO_SIDED|95.0|-1.0|2.3|||Miettinen and Nurminen|One-sided non-inferiority test at alpha=0.025 level||||2.3|-1.0|<0.001
72420874|NCT01984697|144352854|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the seroconversion percentage difference for Girls and Boys 9 to 14 Years - Young Women 16 to 26 years is \> -5.|Seroconversion percentage difference|0.4|||<|0.001|TWO_SIDED|95.0|-1.1|2.3|||Miettinen and Nurminen|One-sided non-inferiority test at alpha=0.025 level||||2.3|-1.1|<0.001
72420875|NCT01984697|144352855|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the GMT ratio for Girls 9 to 14 Years / Young Women 16 to 26 years is \>0.67.|GMT ratio|2.39|||<|0.001|TWO_SIDED|95.0|2.03|2.82|||ANOVA|One-sided non-inferiority test at alpha=0.025 level||||2.82|2.03|<0.001
72420876|NCT01984697|144352855|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the GMT ratio for Boys 9 to 14 Years / Young Women 16 to 26 years is \>0.67.|GMT Ratio|2.45|||<|0.001|TWO_SIDED|95.0|2.09|2.88|||ANOVA|One-sided non-inferiority test at alpha=0.025 level||||2.88|2.09|<0.001
72420877|NCT01984697|144352855|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the GMT ratio for Girls and Boys 9 to 14 Years / Young Women 16 to 26 years is \>0.67.|GMT Ratio|5.07|||<|0.001|TWO_SIDED|95.0|4.32|5.94|||ANOVA|One-sided non-inferiority test at alpha=0.025 level||||5.94|4.32|<0.001
72420878|NCT01984697|144352856|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the GMT ratio for Girls 9 to 14 Years / Young Women 16 to 26 years is \>0.67.|GMT ratio|2.54|||<|0.001|TWO_SIDED|95.0|2.14|3.0|||ANOVA|One-sided non-inferiority test at alpha=0.025 level||||3.00|2.14|<0.001
72420879|NCT01984697|144352856|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the GMT ratio for Boys 9 to 14 Years / Young Women 16 to 26 years is \>0.67.|GMT Ratio|2.69|||<|0.001|TWO_SIDED|95.0|2.29|3.15|||ANOVA|One-sided non-inferiority test at alpha=0.025 level||||3.15|2.29|<0.001
72328858|NCT00244725|144182297|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.45||||0.012|TWO_SIDED|95.0|1.1|1.9|||Fisher Exact|||||1.9|1.1|0.012
72328859|NCT00244725|144182297|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.42||||0.017|TWO_SIDED|95.0|1.1|1.9|||Fisher Exact|||||1.9|1.1|0.017
72328860|NCT00244725|144182297|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.32||||0.08|TWO_SIDED|95.0|1.0|1.8|||Fisher Exact|||||1.8|1.0|0.080
72328861|NCT01539070|144182324|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.3|||<|0.05|TWO_SIDED|95.0|1.8|10.8|||Regression, Linear|All Regression models adjusted for clustering by clinic, child age, change in age, BMI z-score, maternal education and occupation, and season|The change in the average vegetable consumption from baseline to 3 months, the intervention group compared with the usual care group|In intent-to-treat analyses, we used unadjusted and adjusted multivariate regression models, to examine differences from baseline to 3 months between the intervention and usual care groups. For continuous outcomes, we used linear regression models, and for dichotomous outcomes, we used logistic regression models. To account for clustering by practices, we performed generalized linear mixed models. The Estimator (Est) and Confidence Interval 95% (95% CI)are reported.||10.8|1.8|<0.05
72328862|NCT01539070|144182324|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.6|||<|0.05|TWO_SIDED|95.0|-13.6|10.3|||Regression, Linear||The change in the average fruit consumption from baseline to 3 months, the intervention group compared with the usual care group|In intent-to-treat analyses, we used unadjusted and adjusted multivariate regression models, to examine differences from baseline to 3 months between the intervention and usual care groups. For continuous outcomes, we used linear regression models, and for dichotomous outcomes, we used logistic regression models. To account for clustering by practices, we performed generalized linear mixed models. The Estimator (Est) and Confidence Interval 95% (95% CI)are reported.||10.3|-13.6|<0.05
72328863|NCT01539070|144182324|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.6|||<|0.05|TWO_SIDED|95.0|-5.4|6.5|||Regression, Linear||The change in the average water consumption from baseline to 3 months, the intervention group compared with the usual care group|In intent-to-treat analyses, we used unadjusted and adjusted multivariate regression models, to examine differences from baseline to 3 months between the intervention and usual care groups. For continuous outcomes, we used linear regression models, and for dichotomous outcomes, we used logistic regression models. To account for clustering by practices, we performed generalized linear mixed models. The Estimator (Est) and Confidence Interval 95% (95% CI)are reported.||6.5|-5.4|<0.05
72328864|NCT01539070|144182324|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.9|||<|0.05|TWO_SIDED|95.0|-8.9|1.1|||Regression, Linear||The change in the average sweet snacks consumption from baseline to 3 months, the intervention group compared with the usual care group|In intent-to-treat analyses, we used unadjusted and adjusted multivariate regression models, to examine differences from baseline to 3 months between the intervention and usual care groups. For continuous outcomes, we used linear regression models, and for dichotomous outcomes, we used logistic regression models. To account for clustering by practices, we performed generalized linear mixed models. The Estimator (Est) and Confidence Interval 95% (95% CI)are reported.||1.1|-8.9|<0.05
72328865|NCT01539070|144182324|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3|||<|0.05|TWO_SIDED|95.0|-0.5|1.1|||Regression, Linear||The change in the average fast food consumption from baseline to 3 months, the intervention group compared with the usual care group|In intent-to-treat analyses, we used unadjusted and adjusted multivariate regression models, to examine differences from baseline to 3 months between the intervention and usual care groups. For continuous outcomes, we used linear regression models, and for dichotomous outcomes, we used logistic regression models. To account for clustering by practices, we performed generalized linear mixed models. The Estimator (Est) and Confidence Interval 95% (95% CI)are reported.||1.1|-0.5|<0.05
72328866|NCT01539070|144182324|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|||<|0.05|TWO_SIDED|95.0|-0.5|0.0|||Regression, Linear||The change in the average savory snacks consumption from baseline to 3 months, the intervention group compared with the usual care group|In intent-to-treat analyses, we used unadjusted and adjusted multivariate regression models, to examine differences from baseline to 3 months between the intervention and usual care groups. For continuous outcomes, we used linear regression models, and for dichotomous outcomes, we used logistic regression models. To account for clustering by practices, we performed generalized linear mixed models. The Estimator (Est) and Confidence Interval 95% (95% CI)are reported.||0.0|-0.5|<0.05
72328867|NCT01539070|144182324|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7|||<|0.05|TWO_SIDED|95.0|-4.9|3.4|||Regression, Linear||The change in the average sugar-sweetened beverage consumption from baseline to 3 months, the intervention group compared with the usual care group|In intent-to-treat analyses, we used unadjusted and adjusted multivariate regression models, to examine differences from baseline to 3 months between the intervention and usual care groups. For continuous outcomes, we used linear regression models, and for dichotomous outcomes, we used logistic regression models. To account for clustering by practices, we performed generalized linear mixed models. The Estimator (Est) and Confidence Interval 95% (95% CI)are reported.||3.4|-4.9|<0.05
72328868|NCT01539070|144182324|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.2|||<|0.05|TWO_SIDED|95.0|-8.4|4.1|||Regression, Linear||The change in the average added sugar in beverage consumption from baseline to 3 months, the intervention group compared with the usual care group|In intent-to-treat analyses, we used unadjusted and adjusted multivariate regression models, to examine differences from baseline to 3 months between the intervention and usual care groups. For continuous outcomes, we used linear regression models, and for dichotomous outcomes, we used logistic regression models. To account for clustering by practices, we performed generalized linear mixed models. The Estimator (Est) and Confidence Interval 95% (95% CI)are reported.||4.1|-8.4|<0.05
72369787|NCT01621802|144249926|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority criterion for sub cohort 2: The LL of the 2-sided 97.5% CI for the adjusted GMC ratio (Inv\_MMR\_I group divided by pooled Com\_MMR\_I group) was ≥ 0.67 for antibodies to measles, mumps and rubella viruses.|Adjusted GMC ratio|1.03|||||TWO_SIDED|97.5|0.96|1.1|||ANCOVA|Ancova model: adjustment for baseline concentration country - pooled variance|The GMCs were used to calculate the Adjusted GMCs, which in turn were used to calculate the Adjusted GMC ratio with 97.5% confidence interval.|||1.10|0.96|
72328869|NCT01539070|144182325|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.8|||<|0.05|TWO_SIDED|95.0|-29.1|5.5|||Regression, Linear|All Regression models adjusted for clustering by clinic, child age, change in age, BMI z-score, maternal education and occupation, and season|The change in mean physical activity between the baseline measurement and 3 months, the intervention group compared with the control group|In intent-to-treat analyses, we used unadjusted and adjusted multivariate regression models, to examine differences from baseline to 3 months between the intervention and usual care groups. For continuous outcomes, we used linear regression models, and for dichotomous outcomes, we used logistic regression models. To account for clustering by practices, we performed generalized linear mixed models. The Estimator (Est) and Confidence Interval 95% (95% CI) are reported.||5.5|-29.1|<0.05
72328870|NCT01539070|144182325|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2|||<|0.05|TWO_SIDED|95.0|-0.2|0.5|||Regression, Linear||The change in mean sleep time between the baseline measurement and 3 months, the intervention group compared with the control group|In intent-to-treat analyses, we used unadjusted and adjusted multivariate regression models, to examine differences from baseline to 3 months between the intervention and usual care groups. For continuous outcomes, we used linear regression models, and for dichotomous outcomes, we used logistic regression models. To account for clustering by practices, we performed generalized linear mixed models. The Estimator (Est) and Confidence Interval 95% (95% CI)are reported.||0.5|-0.2|<0.05
72328871|NCT01539070|144182325|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.6|||<|0.05|TWO_SIDED|95.0|-4.4|1.1|||Regression, Linear||The change in mean screen time between the baseline measurement and 3 months, the intervention group compared with the control group|In intent-to-treat analyses, we used unadjusted and adjusted multivariate regression models, to examine differences from baseline to 3 months between the intervention and usual care groups. For continuous outcomes, we used linear regression models, and for dichotomous outcomes, we used logistic regression models. To account for clustering by practices, we performed generalized linear mixed models. The Estimator (Est) and Confidence Interval 95% (95% CI)are reported.||1.1|-4.4|<0.05
72328872|NCT01539070|144182327|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.15|||<|0.05|TWO_SIDED|95.0|-0.04|0.35|||Regression, Linear|||In intent-to-treat analyses, we used unadjusted and adjusted multivariate regression models, to examine differences from baseline to 3 months between the intervention and usual care groups. For continuous outcomes, we used linear regression models, and for dichotomous outcomes, we used logistic regression models. To account for clustering by practices, we performed generalized linear mixed models. The Estimator (Est) and Confidence Interval 95% (95% CI)are reported.||0.35|-0.04|<0.05
72328873|NCT02998671|144182328|SUPERIORITY|Comparison at end of Period 1 (P1): CJM112 versus Placebo.|Ratio of geometric means|1.18|||||TWO_SIDED|90.0|0.79|1.81|||Bayesian model for repeated measurements||"Ratio of Geometric Means (CJM112 / Placebo) calculated. A value \> 1 indicates a higher number of lesion counts in the CJM112 group.~Bayesian analysis. The credible interval was calculated and presented under confidence interval."|||1.81|0.79|
72328874|NCT02998671|144182328|SUPERIORITY|Comparison at end of Period 1 (P1): CJM112 versus Placebo.|Ratio of geometric means|1.1|||||TWO_SIDED|90.0|0.66|1.8|||Bayesian model for repeated measurements||"Ratio of Geometric Means (CJM112 / Placebo) calculated. A value \> 1 indicates a higher number of lesion counts in the CJM112 group.~Bayesian analysis. The credible interval was calculated and presented under confidence interval."|||1.80|0.66|
72328875|NCT00418093|144182363|SUPERIORITY_OR_OTHER||Proportion|0.684|||||TWO_SIDED|95.0|0.43|0.87||Exact 95% CI for the partial response rate (13/19 = 0.684): 43.4% \~ 87.4%|Estimation of PR based on Binomial Model|We did not perform a test. Point estimate of PR and its exact 95% CI based on Binomial Model is provided. Thus there is no p-value to report.|Point estimate of PR and its exact 95% CI based on Binomial Model|||0.87|0.43|
72328876|NCT00418093|144182363|SUPERIORITY_OR_OTHER||Single Proportion|0.684|||||TWO_SIDED|95.0|0.434|0.874||We did not perform hypothesis test. We made an estimation for a single proportion (partial response) with its two-sided 95% exact Binomial confidence interval.|Fisher Exact||Estimation of a single proportion (partial response rate) with exact 95% Binomial confidence interval|||0.874|0.434|
72328877|NCT03162796|144182372|SUPERIORITY||Difference in percentage|29.8|||<|0.001|TWO_SIDED|95.0|18.6|41.1|||Cochran-Mantel-Haenszel|||||41.1|18.6|< 0.001
72328878|NCT03162796|144182372|SUPERIORITY||Difference in percentage|37.1|||<|0.001|TWO_SIDED|95.0|26.1|48.2|||Cochran-Mantel-Haenszel|||||48.2|26.1|< 0.001
72328879|NCT03162796|144182373|SUPERIORITY||Least Square (LS) Mean Difference|-0.2483|||<|0.001|TWO_SIDED|95.0|-0.364|-0.1325|||ANCOVA|||||-0.1325|-0.3640|< 0.001
72328880|NCT03162796|144182373|SUPERIORITY||LS Mean difference|-0.3226|||<|0.001|TWO_SIDED|95.0|-0.4385|-0.2066|||ANCOVA|||||-0.2066|-0.4385|< 0.001
72420880|NCT01984697|144352856|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the GMT ratio for Girls and Boys 9 to 14 Years / Young Women 16 to 26 years is \>0.67.|GMT Ratio|4.54|||<|0.001|TWO_SIDED|95.0|3.84|5.37|||ANOVA|One-sided non-inferiority test at alpha=0.025 level||||5.37|3.84|<0.001
72328881|NCT03162796|144182374|SUPERIORITY||Difference in percentage|21.4|||<|0.001|TWO_SIDED|95.0|12.1|30.7||Nominal|Cochran-Mantel-Haenszel|||||30.7|12.1|< 0.001
72328882|NCT03162796|144182374|SUPERIORITY||Difference in percentage|27.2|||<|0.001|TWO_SIDED|95.0|17.6|36.8||Nominal|Cochran-Mantel-Haenszel|||||36.8|17.6|< 0.001
72328883|NCT03162796|144182375|SUPERIORITY||Difference in percentage|42.0|||<|0.001|TWO_SIDED|95.0|28.9|55.1|||Cochran-Mantel-Haenszel|||||55.1|28.9|< 0.001
72328884|NCT03162796|144182375|SUPERIORITY||Difference in percentage|60.0|||<|0.001|TWO_SIDED|95.0|48.3|71.8|||Cochran-Mantel-Haenszel|||||71.8|48.3|< 0.001
72328885|NCT03162796|144182376|SUPERIORITY||Difference in percentage|26.7|||<|0.001|TWO_SIDED|95.0|15.3|38.1||Nominal|Cochran-Mantel-Haenszel|||||38.1|15.3|< 0.001
72328886|NCT03162796|144182376|SUPERIORITY||Difference in percentage|34.8|||<|0.001|TWO_SIDED|95.0|23.5|46.0||Nominal|Cochran-Mantel-Haenszel|||||46.0|23.5|< 0.001
72328887|NCT03162796|144182377|SUPERIORITY||LS Mean difference|-0.73|||<|0.001||95.0|-0.98|-0.48||Nominal|ANCOVA|||||-0.48|-0.98|< 0.001
72328888|NCT03162796|144182377|SUPERIORITY||LS Mean difference|-0.91|||<|0.001||95.0|-1.16|-0.66||Nominal|ANCOVA|||||-0.66|-1.16|< 0.001
72328889|NCT03162796|144182378|SUPERIORITY||Difference in percentage|6.4||||0.069|TWO_SIDED|95.0|-0.3|13.1|||Cochran-Mantel-Haenszel|||||13.1|-0.3|0.069
72328890|NCT03162796|144182378|SUPERIORITY||Difference in percentage|14.8|||<|0.001|TWO_SIDED|95.0|6.9|22.7|||Cochran-Mantel-Haenszel|||||22.7|6.9|< 0.001
72328891|NCT03162796|144182379|SUPERIORITY||Difference in percentage|10.2||||0.036|TWO_SIDED|95.0|1.0|19.3||Nominal|Cochran-Mantel-Haenszel|||||19.3|1.0|0.036
72328892|NCT03162796|144182379|SUPERIORITY||Difference in percentage|13.9||||0.006|TWO_SIDED|95.0|4.4|23.4||Nominal|Cochran-Mantel-Haenszel|||||23.4|4.4|0.006
72328893|NCT03162796|144182380|SUPERIORITY||LS Mean difference|4.14|||<|0.001|TWO_SIDED|95.0|2.42|5.85|||ANCOVA|||||5.85|2.42|< 0.001
72328894|NCT03162796|144182380|SUPERIORITY||LS Mean difference|4.91|||<|0.001||95.0|3.19|6.63|||ANCOVA|||||6.63|3.19|< 0.001
72328895|NCT03162796|144182381|SUPERIORITY||Difference in percentage|13.0||||0.094|TWO_SIDED|95.0|-1.6|27.5||Nominal|Cochran-Mantel-Haenszel|||||27.5|-1.6|0.094
72328896|NCT03162796|144182381|SUPERIORITY||Difference in percentage|19.8||||0.013|TWO_SIDED|95.0|4.9|34.6||Nominal|Cochran-Mantel-Haenszel|||||34.6|4.9|0.013
72328897|NCT03162796|144182382|SUPERIORITY||LS Mean difference|-0.33||||0.185|TWO_SIDED|95.0|-0.83|0.16||Nominal|ANCOVA|||||0.16|-0.83|0.185
72328898|NCT03162796|144182382|SUPERIORITY||LS Mean difference|-0.74||||0.004|TWO_SIDED|95.0|-1.24|-0.24||Nominal|ANCOVA|||||-0.24|-1.24|0.004
72328899|NCT03162796|144182383|SUPERIORITY||LS Mean difference|0.83||||0.398|TWO_SIDED|95.0|-1.1|2.77||Nominal|ANCOVA|||||2.77|-1.10|0.398
72328900|NCT03162796|144182383|SUPERIORITY||LS Mean difference|1.23||||0.214|TWO_SIDED|95.0|-0.71|3.16||Nominal|ANCOVA|||||3.16|-0.71|0.214
72328901|NCT03162796|144182384|SUPERIORITY||Difference in percentage|16.6||||0.088|TWO_SIDED|95.0|-1.5|34.8||Nominal|Cochran-Mantel-Haenszel|||||34.8|-1.5|0.088
72328902|NCT03162796|144182384|SUPERIORITY||Difference in percentage|13.4||||0.212|TWO_SIDED|95.0|-6.9|33.7||Nominal|Cochran-Mantel-Haenszel|||||33.7|-6.9|0.212
72328903|NCT03162796|144182385|SUPERIORITY||LS Mean difference|-1.82||||0.121|TWO_SIDED|95.0|-4.12|0.49||Nominal|ANCOVA|||||0.49|-4.12|0.121
72328904|NCT03162796|144182385|SUPERIORITY||LS Mean difference|-1.53||||0.225|TWO_SIDED|95.0|-4.0|0.95||Nominal|ANCOVA|||||0.95|-4.00|0.225
72328905|NCT01181804|144182475|NON_INFERIORITY_OR_EQUIVALENCE|Comparison of boceprevir tablet versus capsule used a mixed-effects model with fixed effects for formulation, sequence, and period, and a random effect for participant within sequence. The geometric mean ratio (GMR) of boceprevir tablet to boceprevir capsule is presented with two-sided 90% CIs. Equivalence of formulations was signified by the GMR falling within prespecified bioequivalence bounds.|Least Squares Geometric Mean Ratio|1.11|||||TWO_SIDED|90.0|1.07|1.15|||ANOVA|||||1.15|1.07|
72328906|NCT01181804|144182476|NON_INFERIORITY_OR_EQUIVALENCE|Comparison of boceprevir tablet versus capsule used a mixed-effects model with fixed effects for formulation, sequence, and period, and a random effect for participant within sequence. The geometric mean ratio (GMR) of boceprevir tablet to boceprevir capsule is presented with two-sided 90% CIs. Equivalence of formulations was signified by the GMR falling within prespecified bioequivalence bounds.|Least Squares Geometric mean ratio|1.43|||||TWO_SIDED|90.0|1.32|1.54|||ANOVA|||||1.54|1.32|
72328907|NCT01181804|144182477|NON_INFERIORITY_OR_EQUIVALENCE|Comparison of boceprevir tablet versus capsule used a mixed-effects model with fixed effects for formulation, sequence, and period, and a random effect for participant within sequence. The geometric mean ratio (GMR) of boceprevir tablet to boceprevir capsule is presented with two-sided 90% CIs. Equivalence of formulations was signified by the GMR falling within prespecified bioequivalence bounds.|Least Squares Geometric mean ratio|1.1|||||TWO_SIDED|95.0|1.06|1.14|||ANOVA|||||1.14|1.06|
72328908|NCT01181804|144182478|NON_INFERIORITY_OR_EQUIVALENCE|Comparison of boceprevir tablet versus capsule used a mixed-effects model with fixed effects for formulation, sequence, and period, and a random effect for participant within sequence. The geometric mean ratio (GMR) of boceprevir tablet to boceprevir capsule is presented with two-sided 90% CIs. Equivalence of formulations was signified by the GMR falling within prespecified bioequivalence bounds.|Least Squares Geometric mean ratio|1.15|||||TWO_SIDED|90.0|1.09|1.21|||ANOVA|||||1.21|1.09|
72328909|NCT03163134|144182483|OTHER|||||||0.017|||||||Chi-squared|||||||0.017
72328910|NCT03163134|144182484|OTHER|||||||0.577|||||||Chi-squared|||||||0.577
72328911|NCT00005947|144182491|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.45||||0.052||95.0|0.99|2.11|||Log Rank||Obtained from a Cox proportional hazards model with treatment group as the independent variable \[placebo/sipuleucel-T\].|||2.11|0.99|0.052
72328912|NCT00005947|144182491|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.69||||0.052|TWO_SIDED|95.0|0.47|1.01|||Log Rank||Obtained from a Cox proportional hazards model with treatment group as the independent variable \[sipuleucel-T/placebo\]|||1.01|0.47|0.052
72328913|NCT00005947|144182492|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.71||||0.01||95.0|1.13|2.58|||Log Rank||Cox proportional hazards model with treatment as the independent variable \[placebo/sipuleucel-T\].|ITT Population - all randomized participants||2.58|1.13|0.010
72328914|NCT00005947|144182492|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.586||||0.01|TWO_SIDED|95.0|0.388|0.884|||Log Rank||Cox proportional hazards model with treatment as the independent variable \[sipuleucel-T/placebo\]|ITT Population - all randomized participants.||0.884|0.388|0.010
72328915|NCT03980743|144182521|SUPERIORITY|||||||0.97|||||||Mixed Models Analysis|||Time x treatment (week 0 and week 24)||||0.97
72328916|NCT03980743|144182522|SUPERIORITY|||||||0.273|||||||Mixed Models Analysis|||Time x treatment (week 0 and week 24) for Healthy Eating||||0.273
72328917|NCT03980743|144182523|SUPERIORITY|Time x treatment (week 0 and week 24) with sum score||||||0.691|||||||Mixed Models Analysis|||||||0.691
72328918|NCT04551963|144182593|EQUIVALENCE|Two one sided tests procedure by estimation of ratio of geometric means and 90% CI; exponential transformation from estimated difference in natural logarithm scale obtained from linear mixed effect model with treatment as a fixed effect and participant as a random effect.|Ratio of geometric least squares mean|0.49|||||TWO_SIDED|90.0|0.42|0.56||||||Arm A: Zanubrutinib alone vs. Zanubrutinib + fluconazole||0.56|0.42|
72328919|NCT04551963|144182593|EQUIVALENCE|Two one sided tests procedure by estimation of ratio of geometric means and 90% CI; exponential transformation from estimated difference in natural logarithm scale obtained from linear mixed effect model with treatment as a fixed effect and participant as a random effect.|Ratio of geometric least squares mean|0.42|||||TWO_SIDED|90.0|0.34|0.51||||||Arm a: Zanubrutinib alone vs. Zanubrutinib + diltiazem||0.51|0.34|
72328920|NCT04551963|144182594|EQUIVALENCE|Two one sided tests procedure by estimation of ratio of geometric means and 90% CI; exponential transformation from estimated difference in natural logarithm scale obtained from linear mixed effect model with treatment as a fixed effect and participant as a random effect.|Ratio of geometric least squares mean|0.81|||||TWO_SIDED|90.0|0.66|0.99||||||Arm B: Zanubrutinib alone vs. zanubrutinib + voriconazole||0.99|0.66|
72328921|NCT04551963|144182594|EQUIVALENCE|Two one sided tests procedure by estimation of ratio of geometric means and 90% CI; exponential transformation from estimated difference in natural logarithm scale obtained from linear mixed effect model with treatment as a fixed effect and participant as a random effect.|Ratio of geometric least squares mean|0.49|||||TWO_SIDED|90.0|0.41|0.58||||||Arm B: Zanubrutinib alone vs zanubrutinib + clarithromycin||0.58|0.41|
72420881|NCT01984697|144352857|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the GMT ratio for Girls 9 to 14 Years / Young Women 16 to 26 years is \>0.67.|GMT ratio|2.46|||<|0.001|TWO_SIDED|95.0|2.05|2.96|||ANOVA|One-sided non-inferiority test at alpha=0.025 level||||2.96|2.05|<0.001
72328922|NCT04551963|144182595|EQUIVALENCE|Two one sided tests procedure by estimation of ratio of geometric means and 90% CI; exponential transformation from estimated difference in natural logarithm scale obtained from linear mixed effect model with treatment as a fixed effect and participant as a random effect.|Ratio of geometric least squares mean|0.94|||||TWO_SIDED|90.0|0.82|1.08||||||Arm A: Zanubrutinib alone vs. zanubrutinib + fluconazole||1.08|0.82|
72328923|NCT04551963|144182595|EQUIVALENCE|Two one sided tests procedure by estimation of ratio of geometric means and 90% CI; exponential transformation from estimated difference in natural logarithm scale obtained from linear mixed effect model with treatment as a fixed effect and participant as a random effect.|Ratio of geometric least squares mean|0.81|||||TWO_SIDED|90.0|0.66|0.99||||||Arm A: Zanubrutinib alone vs. zanubrutinib + diltiazem||0.99|0.66|
72420882|NCT01984697|144352857|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the GMT ratio for Boys 9 to 14 Years / Young Women 16 to 26 years is \>0.67.|GMT Ratio|2.44|||<|0.001|TWO_SIDED|95.0|2.04|2.92|||ANOVA|One-sided non-inferiority test at alpha=0.025 level||||2.92|2.04|<0.001
72420883|NCT01984697|144352857|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the GMT ratio for Girls and Boys 9 to 14 Years / Young Women 16 to 26 years is \>0.67.|GMT Ratio|3.69|||<|0.001|TWO_SIDED|95.0|3.06|4.45|||ANOVA|One-sided non-inferiority test at alpha=0.025 level||||4.45|3.06|<0.001
72328924|NCT04551963|144182596|EQUIVALENCE|Two one sided tests procedure by estimation of ratio of geometric means and 90% CI; exponential transformation from estimated difference in natural logarithm scale obtained from linear mixed effect model with treatment as a fixed effect and participant as a random effect.|Ratio of geometric least squares mean|0.83|||||TWO_SIDED|90.0|0.65|1.06||||||Arm B: Zanubrutinib alone vs. zanubrutinib + voriconazole||1.06|0.65|
72328925|NCT04551963|144182596|EQUIVALENCE|Two one sided tests procedure by estimation of ratio of geometric means and 90% CI; exponential transformation from estimated difference in natural logarithm scale obtained from linear mixed effect model with treatment as a fixed effect and participant as a random effect.|Ratio of geometric least squares mean|0.48|||||TWO_SIDED|90.0|0.4|0.58||||||Arm B: Zanubrutinib alone vs zanubrutinib + clarithromycin||0.58|0.40|
72328926|NCT04551963|144182597|EQUIVALENCE|Two one sided tests procedure by estimation of ratio of geometric means and 90% CI; exponential transformation from estimated difference in natural logarithm scale obtained from linear mixed effect model with treatment as a fixed effect and participant as a random effect.|Ratio of geometric least squares mean|0.45|||||TWO_SIDED|90.0|0.35|0.58||||||Arm A: Zanubrutinib alone vs. zanubrutinib + fluconazole||0.58|0.35|
72328927|NCT04551963|144182597|EQUIVALENCE|Two one sided tests procedure by estimation of ratio of geometric means and 90% CI; exponential transformation from estimated difference in natural logarithm scale obtained from linear mixed effect model with treatment as a fixed effect and participant as a random effect.|Ratio of geometric least squares mean|0.41|||||TWO_SIDED|90.0|0.32|0.51||||||Arm A: Zanubrutinib alone vs. zanubrutinib + diltiazem||0.51|0.32|
72328928|NCT04551963|144182598|EQUIVALENCE|Two one sided tests procedure by estimation of ratio of geometric means and 90% CI; exponential transformation from estimated difference in natural logarithm scale obtained from linear mixed effect model with treatment as a fixed effect and participant as a random effect.|Ratio of geometric least squares mean|0.82|||||TWO_SIDED|90.0|0.68|1.0||||||Arm B: Zanubrutinib alone vs. zanubrutinib + voriconazole||1.00|0.68|
72328929|NCT04551963|144182598|EQUIVALENCE|Two one sided tests procedure by estimation of ratio of geometric means and 90% CI; exponential transformation from estimated difference in natural logarithm scale obtained from linear mixed effect model with treatment as a fixed effect and participant as a random effect.|Ratio of geometric least squares mean|0.5|||||TWO_SIDED|90.0|0.39|0.64||||||Arm B: Zanubrutinib alone vs. zanubrutinib + clarithromycin||0.64|0.39|
72328930|NCT00700622|144182623|NON_INFERIORITY_OR_EQUIVALENCE|A sample size of 92 subjects in each group was required to complete the trial. Approximately 230 subjects were to be randomized to achieve 184 completers (assuming a 20% dropout rate). This would have provided 80% power for a noninferiority design to test the difference of a 4-month change in HbA1c levels between treatment groups, assuming the upper noninferiority margins Δ of 0.5% with a standard deviation of 1.2 and a 1-sided alpha of 0.025.|Mean Difference (Net)|-0.07|STANDARD_ERROR_OF_MEAN|0.119|||TWO_SIDED|95.0|-0.31|0.17|||ANCOVA|||||0.17|-0.31|
72328931|NCT01204905|144182672|OTHER|This was a pilot study with a small sample population. There were no power calculations performed.|||||||||||||||||The percentage of patients with HIV-1 viral loads less than 50 c/ml at 48 weeks.|||
72328932|NCT01204905|144182673|OTHER|There were no power calculations performed due to the size of the pilot study.|||||||||||||||||Number of weeks to virologic suppression|||
72328933|NCT00803361|144182682|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.62||||0.006|TWO_SIDED|95.0|-2.76|-0.48||p-value is for Change from Baseline.|ANCOVA|Change = Treatment + Pooled Investigator + Baseline||||-0.48|-2.76|0.006
72328934|NCT00803361|144182683|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.56||||0.024|TWO_SIDED|95.0|-4.78|-0.34||p-value is for Change from Baseline|ANCOVA|Change = Treatment + Pooled Investigator + Baseline||||-0.34|-4.78|0.024
72328935|NCT00803361|144182684|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.44||||0.004|TWO_SIDED|95.0|-0.74|-0.15|||ANOVA|||||-0.15|-0.74|0.004
72328936|NCT00803361|144182685|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.41||||0.125|TWO_SIDED|95.0|-0.93|0.11||p-value is for Severity of Worst Pain Change.|ANCOVA|Change = Treatment + Pooled Investigator + Baseline||||0.11|-0.93|0.125
72328937|NCT00803361|144182685|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.42||||0.014|TWO_SIDED|95.0|-0.75|-0.09||p-value is for Severity of Least Pain Change.|ANCOVA|Change = Treatment + Pooled Investigator + Baseline||||-0.09|-0.75|0.014
72328938|NCT00803361|144182685|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.52||||0.012|TWO_SIDED|95.0|-0.93|-0.11||p-value is for Severity of Average Pain Change.|ANCOVA|Change = Treatment + Pooled Investigator + Baseline||||-0.11|-0.93|0.012
72328939|NCT00803361|144182685|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.69||||0.002|TWO_SIDED|95.0|-1.14|-0.25||p-value is for Severity of Pain Right Now Change.|ANCOVA|Change = Treatment + Pooled Investigator + Baseline||||-0.25|-1.14|0.002
72328940|NCT00803361|144182685|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4||||0.101|TWO_SIDED|95.0|-0.87|0.08||p-value is for Interference of Pain, General Activity, Change.|ANCOVA|Change = Treatment + Pooled Investigator + Baseline||||0.08|-0.87|0.101
72328941|NCT00803361|144182685|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.31||||0.252|TWO_SIDED|95.0|-0.83|0.22||p-value is for Interference of Pain, Mood, Change.|ANCOVA|Change = Treatment + Pooled Investigator + Baseline||||0.22|-0.83|0.252
72328942|NCT00803361|144182685|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3||||0.149|TWO_SIDED|95.0|-0.72|0.11||p-value is for Interference of Pain,Walking Ability, Change.|ANCOVA|Change = Treatment + Pooled Investigator + Baseline||||0.11|-0.72|0.149
72328943|NCT00803361|144182685|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.22||||0.367|TWO_SIDED|95.0|-0.71|0.26||p-value is for Interference of Pain, Normal Work, Change.|ANCOVA|Change = Treatment + Pooled Investigator + Baseline||||0.26|-0.71|0.367
72328944|NCT00803361|144182685|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.18||||0.395|TWO_SIDED|95.0|-0.59|0.24||p-value is for Interference of Pain, Relations with Others, Change.|ANCOVA|Change = Treatment + Pooled Investigator + Baseline||||0.24|-0.59|0.395
72420884|NCT01984697|144352858|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the GMT ratio for Girls 9 to 14 Years / Young Women 16 to 26 years is \>0.67.|GMT ratio|2.51|||<|0.001|TWO_SIDED|95.0|2.1|3.0|||ANOVA|One-sided non-inferiority test at alpha=0.025 level||||3.00|2.10|<0.001
72420885|NCT01984697|144352858|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the GMT ratio for Boys 9 to 14 Years / Young Women 16 to 26 years is \>0.67.|GMT Ratio|2.62|||<|0.001|TWO_SIDED|95.0|2.2|3.12|||ANOVA|One-sided non-inferiority test at alpha=0.025 level||||3.12|2.20|<0.001
72420886|NCT01984697|144352858|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the GMT ratio for Girls and Boys 9 to 14 Years / Young Women 16 to 26 years is \>0.67.|GMT Ratio|3.7|||<|0.001|TWO_SIDED|95.0|3.08|4.45|||ANOVA|One-sided non-inferiority test at alpha=0.025 level||||4.45|3.08|<0.001
72420887|NCT01984697|144352859|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the GMT ratio for Girls 9 to 14 Years / Young Women 16 to 26 years is \>0.67.|GMT ratio|2.96|||<|0.001|TWO_SIDED|95.0|2.5|3.5|||ANOVA|One-sided non-inferiority test at alpha=0.025 level||||3.50|2.50|<0.001
72420888|NCT01984697|144352859|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the GMT ratio for Boys 9 to 14 Years / Young Women 16 to 26 years is \>0.67.|GMT Ratio|2.99|||<|0.001|TWO_SIDED|95.0|2.55|3.5|||ANOVA|One-sided non-inferiority test at alpha=0.025 level||||3.50|2.55|<0.001
72420889|NCT01984697|144352859|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the GMT ratio for Girls and Boys 9 to 14 Years / Young Women 16 to 26 years is \>0.67.|GMT Ratio|6.31|||<|0.001|TWO_SIDED|95.0|5.36|7.43|||ANOVA|One-sided non-inferiority test at alpha=0.025 level||||7.43|5.36|<0.001
72420890|NCT01984697|144352860|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the GMT ratio for Girls 9 to 14 Years / Young Women 16 to 26 years is \>0.67.|GMT ratio|1.67|||<|0.001|TWO_SIDED|95.0|1.38|2.03|||ANOVA|One-sided non-inferiority test at alpha=0.025 level||||2.03|1.38|<0.001
72420891|NCT01984697|144352860|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the GMT ratio for Boys 9 to 14 Years / Young Women 16 to 26 years is \>0.67.|GMT Ratio|1.65|||<|0.001|TWO_SIDED|95.0|1.37|1.99|||ANOVA|One-sided non-inferiority test at alpha=0.025 level||||1.99|1.37|<0.001
72420892|NCT01984697|144352860|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the GMT ratio for Girls and Boys 9 to 14 Years / Young Women 16 to 26 years is \>0.67.|GMT Ratio|1.96|||<|0.001|TWO_SIDED|95.0|1.61|2.37|||ANOVA|One-sided non-inferiority test at alpha=0.025 level||||2.37|1.61|<0.001
72420893|NCT01984697|144352861|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the GMT ratio for Girls 9 to 14 Years / Young Women 16 to 26 years is \>0.67.|GMT ratio|1.6|||<|0.001|TWO_SIDED|95.0|1.36|1.87|||ANOVA|One-sided non-inferiority test at alpha=0.025 level||||1.87|1.36|<0.001
72420894|NCT01984697|144352861|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the GMT ratio for Boys 9 to 14 Years / Young Women 16 to 26 years is \>0.67.|GMT Ratio|1.76|||<|0.001|TWO_SIDED|95.0|1.51|2.05|||ANOVA|One-sided non-inferiority test at alpha=0.025 level||||2.05|1.51|<0.001
72420895|NCT01984697|144352861|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the GMT ratio for Girls and Boys 9 to 14 Years / Young Women 16 to 26 years is \>0.67.|GMT Ratio|3.08|||<|0.001|TWO_SIDED|95.0|2.64|3.61|||ANOVA|One-sided non-inferiority test at alpha=0.025 level||||3.61|2.64|<0.001
72420896|NCT01984697|144352862|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the GMT ratio for Girls 9 to 14 Years / Young Women 16 to 26 years is \>0.67.|GMT ratio|2.55|||<|0.001|TWO_SIDED|95.0|2.15|3.01|||ANOVA|One-sided non-inferiority test at alpha=0.025 level||||3.01|2.15|<0.001
72420897|NCT01984697|144352862|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the GMT ratio for Boys 9 to 14 Years / Young Women 16 to 26 years is \>0.67.|GMT Ratio|2.7|||<|0.001|TWO_SIDED|95.0|2.3|3.16|||ANOVA|One-sided non-inferiority test at alpha=0.025 level||||3.16|2.30|<0.001
72420898|NCT01984697|144352862|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the GMT ratio for Girls and Boys 9 to 14 Years / Young Women 16 to 26 years is \>0.67.|GMT Ratio|4.98|||<|0.001|TWO_SIDED|95.0|4.23|5.86|||ANOVA|One-sided non-inferiority test at alpha=0.025 level||||5.86|4.23|<0.001
72420899|NCT01984697|144352863|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the seroconversion percentage difference for Girls 9 to 14 Years - Young Women 16 to 26 years is \> -5.|Seroconversion percentage difference|0.4|||<|0.001|TWO_SIDED|95.0|-1.1|2.3|||Miettinen and Nurminen|One-sided non-inferiority test at alpha=0.025 level||||2.3|-1.1|<0.001
72420900|NCT01984697|144352863|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the seroconversion percentage difference for Boys 9 to 14 Years - Young Women 16 to 26 years is \> -5.|Seroconversion percentage difference|0.4|||<|0.001|TWO_SIDED|95.0|-1.0|2.3|||Miettinen and Nurminen|One-sided non-inferiority test at alpha=0.025 level||||2.3|-1.0|<0.001
72420901|NCT01984697|144352863|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the seroconversion percentage difference for Girls and Boys 9 to 14 Years - Young Women 16 to 26 years is \> -5.|Seroconversion percentage difference|0.4|||<|0.001|TWO_SIDED|95.0|-1.1|2.3|||Miettinen and Nurminen|One-sided non-inferiority test at alpha=0.025 level||||2.3|-1.1|<0.001
72420902|NCT01984697|144352864|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the seroconversion percentage difference for Girls 9 to 14 Years - Young Women 16 to 26 years is \> -5.|Seroconversion percentage difference|0.4|||<|0.001|TWO_SIDED|95.0|-1.0|2.2|||Miettinen and Nurminen|One-sided non-inferiority test at alpha=0.025 level||||2.2|-1.0|<0.001
72420903|NCT01984697|144352864|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the seroconversion percentage difference for Boys 9 to 14 Years - Young Women 16 to 26 years is \> -5.|Seroconversion percentage difference|0.4|||<|0.001|TWO_SIDED|95.0|-1.0|2.2|||Miettinen and Nurminen|One-sided non-inferiority test at alpha=0.025 level||||2.2|-1.0|<0.001
72420904|NCT01984697|144352864|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the seroconversion percentage difference for Girls and Boys 9 to 14 Years - Young Women 16 to 26 years is \> -5.|Seroconversion percentage difference|0.4|||<|0.001|TWO_SIDED|95.0|-1.0|2.2|||Miettinen and Nurminen|One-sided non-inferiority test at alpha=0.025 level||||2.2|-1.0|<0.001
72420905|NCT01984697|144352865|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the seroconversion percentage difference for Girls 9 to 14 Years - Young Women 16 to 26 years is \> -5.|Seroconversion percentage difference|1.5|||<|0.001|TWO_SIDED|95.0|0.1|3.8|||Miettinen and Nurminen|One-sided non-inferiority test at alpha=0.025 level||||3.8|0.1|<0.001
72420906|NCT01984697|144352865|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the seroconversion percentage difference for Boys 9 to 14 Years - Young Women 16 to 26 years is \> -5.|Seroconversion percentage difference|1.5|||<|0.001|TWO_SIDED|95.0|0.1|3.8|||Miettinen and Nurminen|One-sided non-inferiority test at alpha=0.025 level||||3.8|0.1|<0.001
72420907|NCT01984697|144352865|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the seroconversion percentage difference for Girls and Boys 9 to 14 Years - Young Women 16 to 26 years is \> -5.|Seroconversion percentage difference|1.5|||<|0.001|TWO_SIDED|95.0|0.1|3.8|||Miettinen and Nurminen|One-sided non-inferiority test at alpha=0.025 level||||3.8|0.1|<0.001
72420908|NCT01984697|144352866|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the seroconversion percentage difference for Girls 9 to 14 Years - Young Women 16 to 26 years is \> -5.|Seroconversion percentage difference|0.0|||<|0.001|TWO_SIDED|95.0|-1.7|1.8|||Miettinen and Nurminen|One-sided non-inferiority test at alpha=0.025 level||||1.8|-1.7|<0.001
72420909|NCT01984697|144352866|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the seroconversion percentage difference for Boys 9 to 14 Years - Young Women 16 to 26 years is \> -5.|Seroconversion percentage difference|0.4|||<|0.001|TWO_SIDED|95.0|-1.0|2.1|||Miettinen and Nurminen|One-sided non-inferiority test at alpha=0.025 level||||2.1|-1.0|<0.001
72420910|NCT01984697|144352866|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the seroconversion percentage difference for Girls and Boys 9 to 14 Years - Young Women 16 to 26 years is \> -5.|Seroconversion percentage difference|0.4|||<|0.001|TWO_SIDED|95.0|-1.0|2.1|||Miettinen and Nurminen|One-sided non-inferiority test at alpha=0.025 level||||2.1|-1.0|<0.001
72420911|NCT01984697|144352867|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the seroconversion percentage difference for Girls 9 to 14 Years - Young Women 16 to 26 years is \> -5.|Seroconversion percentage difference|0.0|||<|0.001|TWO_SIDED|95.0|-1.7|1.7|||Miettinen and Nurminen|One-sided non-inferiority test at alpha=0.025 level||||1.7|-1.7|<0.001
72420912|NCT01984697|144352867|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the seroconversion percentage difference for Boys 9 to 14 Years - Young Women 16 to 26 years is \> -5.|Seroconversion percentage difference|0.4|||<|0.001|TWO_SIDED|95.0|-1.0|2.0|||Miettinen and Nurminen|One-sided non-inferiority test at alpha=0.025 level||||2.0|-1.0|<0.001
72420913|NCT01984697|144352867|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the seroconversion percentage difference for Girls and Boys 9 to 14 Years - Young Women 16 to 26 years is \> -5.|Seroconversion percentage difference|0.4|||<|0.001|TWO_SIDED|95.0|-1.1|2.0|||Miettinen and Nurminen|One-sided non-inferiority test at alpha=0.025 level||||2.0|-1.1|<0.001
72420914|NCT01984697|144352868|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the seroconversion percentage difference for Girls 9 to 14 Years - Young Women 16 to 26 years is \> -5.|Seroconversion percentage difference|1.4|||<|0.001|TWO_SIDED|95.0|-0.7|4.0|||Miettinen and Nurminen|One-sided non-inferiority test at alpha=0.025 level||||4.0|-0.7|<0.001
72328945|NCT00803361|144182685|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.09||||0.731|TWO_SIDED|95.0|-0.63|0.44||p-value is for Interference of Pain, Sleep, Change.|ANCOVA|Change = Treatment + Pooled Investigator + Baseline||||0.44|-0.63|0.731
72420915|NCT01984697|144352868|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the seroconversion percentage difference for Boys 9 to 14 Years - Young Women 16 to 26 years is \> -5.|Seroconversion percentage difference|1.4|||<|0.001|TWO_SIDED|95.0|-0.7|4.0|||Miettinen and Nurminen|One-sided non-inferiority test at alpha=0.025 level||||4.0|-0.7|<0.001
72420916|NCT01984697|144352868|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the seroconversion percentage difference for Girls and Boys 9 to 14 Years - Young Women 16 to 26 years is \> -5.|Seroconversion percentage difference|2.1|||<|0.001|TWO_SIDED|95.0|0.7|4.6|||Miettinen and Nurminen|One-sided non-inferiority test at alpha=0.025 level||||4.6|0.7|<0.001
72420917|NCT01984697|144352869|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the seroconversion percentage difference for Girls 9 to 14 Years - Young Women 16 to 26 years is \> -5.|Seroconversion percentage difference|0.0|||<|0.001|TWO_SIDED|95.0|-1.7|1.7|||Miettinen and Nurminen|One-sided non-inferiority test at alpha=0.025 level||||1.7|-1.7|<0.001
72420918|NCT01984697|144352869|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the seroconversion percentage difference for Boys 9 to 14 Years - Young Women 16 to 26 years is \> -5.|Seroconversion percentage difference|0.4|||<|0.001|TWO_SIDED|95.0|-1.0|2.1|||Miettinen and Nurminen|One-sided non-inferiority test at alpha=0.025 level||||2.1|-1.0|<0.001
72420919|NCT01984697|144352869|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the seroconversion percentage difference for Girls and Boys 9 to 14 Years - Young Women 16 to 26 years is \> -5.|Seroconversion percentage difference|0.4|||<|0.001|TWO_SIDED|95.0|-1.0|2.1|||Miettinen and Nurminen|One-sided non-inferiority test at alpha=0.025 level||||2.1|-1.0|<0.001
72420920|NCT01984697|144352870|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the seroconversion percentage difference for Girls 9 to 14 Years - Young Women 16 to 26 years is \> -5.|Seroconversion percentage difference|0.4|||<|0.001|TWO_SIDED|95.0|-1.0|2.1|||Miettinen and Nurminen|One-sided non-inferiority test at alpha=0.025 level||||2.1|-1.0|<0.001
72420921|NCT01984697|144352870|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the seroconversion percentage difference for Boys 9 to 14 Years - Young Women 16 to 26 years is \> -5.|Seroconversion percentage difference|0.4|||<|0.001|TWO_SIDED|95.0|-1.0|2.1|||Miettinen and Nurminen|One-sided non-inferiority test at alpha=0.025 level||||2.1|-1.0|<0.001
72420922|NCT01984697|144352870|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the seroconversion percentage difference for Girls and Boys 9 to 14 Years - Young Women 16 to 26 years is \> -5.|Seroconversion percentage difference|0.4|||<|0.001|TWO_SIDED|95.0|-1.1|2.1|||Miettinen and Nurminen|One-sided non-inferiority test at alpha=0.025 level||||2.1|-1.1|<0.001
72420923|NCT00847405|144352885|NON_INFERIORITY_OR_EQUIVALENCE|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|103.64||||||90.0|95.93|111.97|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||111.97|95.93|
72420924|NCT00847405|144352886|NON_INFERIORITY_OR_EQUIVALENCE|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|102.81||||||90.0|97.95|107.91|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||107.91|97.95|
72420925|NCT00847405|144352887|NON_INFERIORITY_OR_EQUIVALENCE|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|103.25||||||90.0|98.35|108.41|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||108.41|98.35|
72420926|NCT00949715|144352892|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.0||||0.2352|TWO_SIDED|95.0|-2.7|10.8|||t-test, 2 sided|||HO: Pacing at selective RV sites (mid-septum or apex) has no different impact on the change in LVEF after 24 months follow-up. With 12% SD and 80 subjects in groups will have 90% power to detect an absolute difference in LVEF of 6.2% at 24 months follow-up at an alpha level of 0.05.||10.8|-2.7|0.2352
72420927|NCT00949715|144352893|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.1||||0.7405|TWO_SIDED|95.0|-7.6|5.5|||t-test, 2 sided|||Ho: Packing at selective RV sites (mid-Septum or apex) has no different impact on LVEF change from 2 weeks to 24 months.||5.5|-7.6|0.7405
72420928|NCT00949715|144352894|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-11.3||||0.1051|TWO_SIDED|95.0|-25.1|2.4|||t-test, 2 sided|||Ho: Pacing at selective sites (RVS or RVA) has no different impact on LV end systolic volume||2.4|-25.1|0.1051
72420929|NCT00949715|144352895|SUPERIORITY_OR_OTHER||Mean Difference (Net)|9.9||||0.9835||95.0||||Adjusting for age and gender|Wilcoxon (Mann-Whitney)|Rank Sum||Ho: The AT/AF burden in the RVS group is the same as the RVA group.||||0.9835
72420930|NCT00605202|144352948|SUPERIORITY_OR_OTHER|||||||0.007||95.0||||P-value of the change in the plasma potassium (baseline to 2 weeks) between arms|t-test, 2 sided|||Statistical analysis applies to the change in the plasma potassium (baseline to 2 weeks) between arms||||0.007
72420931|NCT02276066|144352949|OTHER|We performed a delta analysis, by graphing the difference between the two measurements, we wanted to visually assess the degree of agreement or discrepancy between the two methods. We were looking to evaluate the consistency, accuracy, or bias between different measurement techniques.|||||<|0.05|||||||Delta analysis|||||||<0.05
72420932|NCT03928028|144352955|SUPERIORITY|||||||0.507||||||a priori threshold for statistical significance = .15|generalized estimating equation|||This analysis compares mothers in FBT to mothers in FBT+Parent-focused CRT||||.507
72420933|NCT03928028|144352955|SUPERIORITY|||||||0.017||||||a priori threshold for statistical significance = .15|generalized estimating equation|||This analysis compares fathers in FBT to fathers in FBT+Parent-focused CRT||||.017
72420934|NCT03928028|144352955|SUPERIORITY|||||||0.139||||||a priori threshold for statistical significance = .15|generalized estimating equation|||This analysis compares adolescents in FBT to adolescents in FBT+Adolescent-focused CRT||||.139
72328946|NCT00803361|144182685|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.34||||0.186|TWO_SIDED|95.0|-0.85|0.17||p-value is for Interference of Pain, Enjoyment of Life, Change.|ANCOVA|Change = Treatment + Pooled Investigator + Baseline||||0.17|-0.85|0.186
72420935|NCT03928028|144352956|SUPERIORITY|||||||0.389|||||||generalized estimating equation|||This analysis compare mothers in FBT to mothers in FBT+CRTp||||.389
72420936|NCT03928028|144352956|SUPERIORITY|||||||0.447||||||a priori threshold for statistical significance = .15|generalized estimating equation|||This analysis compares fathers in FBT to fathers in FBT+Parent-focused CRT||||.447
72420937|NCT03928028|144352956|SUPERIORITY||||||<|0.001||||||a priori threshold for statistical significance = .15|generalized estimating equation|||This analysis compares adolescents in FBT to adolescents in FBT+Adolescent-focused CRT||||<.001
72420938|NCT03928028|144352957|SUPERIORITY|||||||0.778||||||a priori threshold for statistical significance = .15|generalized estimating equation|||This analysis compares mothers in FBT to mothers in FBT+Parent-focused CRT||||.778
72420939|NCT03928028|144352957|SUPERIORITY|||||||0.297||||||a priori threshold for statistical significance = .15|generalized estimating equation|||This analysis compares mothers in FBT to mothers in FBT+Parent-focused CRT||||.297
72420940|NCT03928028|144352957|SUPERIORITY|||||||0.062||||||a priori threshold for statistical significance = .15|generalized estimating equation|||This analysis compares adolescents in FBT to adolescents in FBT+Adolescent-focused CRT||||.062
72420941|NCT03928028|144352958|SUPERIORITY|||||||0.069||||||a priori threshold for statistical significance = .15|generalized estimating equation|||This analysis compares mothers in FBT to mothers in FBT+Parent-focused CRT||||.069
72420942|NCT03928028|144352958|SUPERIORITY|||||||0.323||||||a priori threshold for statistical significance = .15|generalized estimating equation|||This analysis compares fathers in FBT to fathers in FBT+Parent-focused CRT||||.323
72420943|NCT03928028|144352958|SUPERIORITY|||||||0.225|||||||generalized estimating equation|||This analysis compares adolescents in FBT to adolescents in FBT+Adolescent-focused CRT||||.225
72420944|NCT03928028|144352959|SUPERIORITY|||||||0.196||||||a priori threshold for statistical significance = .15|generalized estimating equation|||This analysis compares mothers in FBT to mothers in FBT+Parent-focused CRT||||.196
72420945|NCT03928028|144352959|SUPERIORITY|||||||0.812||||||a priori threshold for statistical significance = .15|generalized estimating equation|||This analysis compares fathers in FBT to fathers in FBT+Parent-focused CRT||||.812
72420946|NCT03928028|144352959|SUPERIORITY|||||||0.499||||||a priori threshold for statistical significance = .15|generalized estimating equation|||This analysis compares adolescents in FBT to adolescents in FBT+Adolescent-focused CRT||||.499
72420947|NCT03928028|144352960|SUPERIORITY|||||||0.446||||||a priori threshold for statistical significance = .15|generalized estimating equation|||This analysis compares mothers in FBT to mothers in FBT+Parent-focused CRT||||.446
72328947|NCT00803361|144182685|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.26||||0.22|TWO_SIDED|95.0|-0.67|0.16||p-value is for Mean Interference Score, Change.|ANCOVA|Change = Treatment + Pooled Investigator + Baseline||||0.16|-0.67|0.220
72420948|NCT03928028|144352960|SUPERIORITY|||||||0.647|||||||generalized estimating equation|||This analysis compares fathers in FBT to fathers in FBT+Parent-focused CRT||||.647
72420949|NCT03928028|144352960|SUPERIORITY|||||||0.765||||||a priori threshold for statistical significance = .15|generalized estimating equation|||This analysis compares adolescents in FBT to adolescents in FBT+Adolescent-focused CRT||||.765
72420950|NCT03928028|144352961|SUPERIORITY|||||||0.425||||||a priori threshold for statistical significance = .15|generalized estimating equation|||This analysis compares mothers in FBT to mothers in FBT+Parent-focused CRT||||.425
72420951|NCT03928028|144352961|SUPERIORITY|||||||0.63|||||||generalized estimating equation|||This analysis compares fathers in FBT to fathers in FBT+Parent-focused CRT||||.630
72420952|NCT03928028|144352961|SUPERIORITY|||||||0.854||||||a priori threshold for statistical significance = .15|generalized estimating equation|||This analysis compares adolescents in FBT to adolescents in FBT+Adolescent-focused CRT||||.854
72420953|NCT04525547|144352965|OTHER|||||||0.817|||||||t-test, 2 sided|||||||0.8170
72420954|NCT04525547|144352966|OTHER|||||||0.6533|||||||t-test, 2 sided|||||||0.6533
72420955|NCT04425902|144352974|OTHER||Ratio of geometric least square mean|1.11|||||TWO_SIDED|90.0|0.94|1.32|||||A mixed-effect model with treatment as a fixed effect and measurements within participant as repeated measures was performed on the natural ln-transformed parameter.|||1.32|0.94|
72420956|NCT04425902|144352975|OTHER||Ratio of geometric least square mean|1.12|||||TWO_SIDED|90.0|0.95|1.32|||||A mixed-effect model with treatment as a fixed effect and measurements within participant as repeated measures was performed on the natural ln-transformed parameter.|||1.32|0.95|
72420957|NCT04425902|144352976|OTHER||Ratio of geometric least square mean|0.95|||||TWO_SIDED|90.0|0.83|1.08|||||A mixed-effect model with treatment as a fixed effect and measurements within participant as repeated measures was performed on the natural ln-transformed parameter.|||1.08|0.83|
72420958|NCT04425902|144352979|OTHER||Ratio of geometric least square mean|1.23|||||TWO_SIDED|90.0|0.71|2.14|||||A mixed-effect model with treatment as a fixed effect and measurements within participant as repeated measures was performed on the natural ln-transformed parameter.|||2.14|0.71|
72420959|NCT04425902|144352980|OTHER||Ratio of geometric least square mean|1.23|||||TWO_SIDED|90.0|0.71|2.14|||||A mixed-effect model with treatment as a fixed effect and measurements within participant as repeated measures was performed on the natural ln-transformed parameter.|||2.14|0.71|
72420960|NCT04425902|144352981|OTHER||Ratio of geometric least square mean|1.11|||||TWO_SIDED|90.0|0.72|1.69|||||A mixed-effect model with treatment as a fixed effect and measurements within participant as repeated measures was performed on the natural ln-transformed parameter.|||1.69|0.72|
72420961|NCT04425902|144352984|OTHER||Ratio of geometric least square mean|1.08|||||TWO_SIDED|90.0|0.97|1.2|||||A mixed-effect model with treatment as a fixed effect and measurements within participant as repeated measures was performed on the natural ln-transformed parameter.|||1.20|0.97|
72420962|NCT04425902|144352985|OTHER||Ratio of geometric least square mean|1.09|||||TWO_SIDED|90.0|0.98|1.21|||||A mixed-effect model with treatment as a fixed effect and measurements within participant as repeated measures was performed on the natural ln-transformed parameter.|||1.21|0.98|
72420963|NCT04425902|144352986|OTHER||Ratio of geometric least square mean|1.04|||||TWO_SIDED|90.0|0.92|1.17|||||A mixed-effect model with treatment as a fixed effect and measurements within participant as repeated measures was performed on the natural ln-transformed parameter.|||1.17|0.92|
72420964|NCT04425902|144352989|OTHER||Ratio of geometric least square mean|1.02|||||TWO_SIDED|90.0|0.88|1.18|||||A mixed-effect model with treatment as a fixed effect and measurements within participant as repeated measures was performed on the natural ln-transformed parameter.|||1.18|0.88|
72420965|NCT04425902|144352990|OTHER||Ratio of geometric least square mean|1.03|||||TWO_SIDED|90.0|0.89|1.19|||||A mixed-effect model with treatment as a fixed effect and measurements within participant as repeated measures was performed on the natural ln-transformed parameter.|||1.19|0.89|
72420966|NCT04425902|144352991|OTHER||Ratio of geometric least square mean|1.05|||||TWO_SIDED|90.0|0.93|1.18|||||A mixed-effect model with treatment as a fixed effect and measurements within participant as repeated measures was performed on the natural ln-transformed parameter.|||1.18|0.93|
72328948|NCT00803361|144182686|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.61||||0.076|TWO_SIDED|95.0|-1.29|0.06||p-value is for symptoms have disrupted your work/schoolwork - change.|ANCOVA|Change = Treatment + Pooled Investigator + Baseline||||0.06|-1.29|0.076
72328949|NCT00803361|144182686|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5||||0.14|TWO_SIDED|95.0|-1.16|0.17||p-value is for symptoms disrupted social/leisure - change.|ANCOVA|Change = Treatment + Pooled Investigator + Baseline||||0.17|-1.16|0.140
72328950|NCT00803361|144182686|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.53||||0.087|TWO_SIDED|95.0|-1.14|0.08||p-value is for symptoms disrupted family life - change.|ANCOVA|Change = Treatment + Pooled Investigator + Baseline||||0.08|-1.14|0.087
72328951|NCT00803361|144182686|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.62||||0.083|TWO_SIDED|95.0|-3.46|0.21||p-value is for Global Functional Impairment Total Score - change|ANCOVA|Change = Treatment + Pooled Investigator + Baseline||||0.21|-3.46|0.083
72328952|NCT00803361|144182687|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.32||||0.063|TWO_SIDED|95.0|-10.93|0.3||p-value is for Severity of Overall Pain, Past Week, Change|ANCOVA|Model: Change = Treatment + Pooled Investigator + Baseline||||0.30|-10.93|0.063
72328953|NCT00803361|144182687|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.21||||0.66|TWO_SIDED|95.0|-6.64|4.22||p-value is for Severity of Headaches, Past Week, Change.|ANCOVA|Model: Change = Treatment + Pooled Investigator + Baseline||||4.22|-6.64|0.660
72420967|NCT04425902|144352994|OTHER||Ratio of geometric least square mean|1.12|||||TWO_SIDED|90.0|0.72|1.75|||||A mixed-effect model with treatment as a fixed effect and measurements within participant as repeated measures was performed on the natural ln-transformed parameter.|||1.75|0.72|
72420968|NCT04425902|144352995|OTHER||Ratio of geometric least square mean|0.97|||||TWO_SIDED|90.0|0.54|1.73|||||A mixed-effect model with treatment as a fixed effect and measurements within participant as repeated measures was performed on the natural ln-transformed parameter.|||1.73|0.54|
72420969|NCT04425902|144352996|OTHER||Ratio of geometric least square mean|1.14|||||TWO_SIDED|90.0|0.73|1.78|||||A mixed-effect model with treatment as a fixed effect and measurements within participant as repeated measures was performed on the natural ln-transformed parameter.|||1.78|0.73|
72420970|NCT04425902|144352999|OTHER||Ratio of geometric least square mean|0.94|||||TWO_SIDED|90.0|0.8|1.11|||||A mixed-effect model with treatment as a fixed effect and measurements within participant as repeated measures was performed on the natural ln-transformed parameter.|||1.11|0.80|
72420971|NCT04425902|144353000|OTHER||Ratio of geometric least square mean|0.93|||||TWO_SIDED|90.0|0.79|1.1|||||A mixed-effect model with treatment as a fixed effect and measurements within participant as repeated measures was performed on the natural ln-transformed parameter.|||1.10|0.79|
72420972|NCT04425902|144353001|OTHER||Ratio of geometric least square mean|0.9|||||TWO_SIDED|90.0|0.73|1.12|||||A mixed-effect model with treatment as a fixed effect and measurements within participant as repeated measures was performed on the natural ln-transformed parameter.|||1.12|0.73|
72420973|NCT04425902|144353004|OTHER||Ratio of geometric least square mean|1.07|||||TWO_SIDED|90.0|0.94|1.22|||||A mixed-effect model with treatment as a fixed effect and measurements within participant as repeated measures was performed on the natural ln-transformed parameter.|||1.22|0.94|
72420974|NCT04425902|144353005|OTHER||Ratio of geometric least square mean|1.05|||||TWO_SIDED|90.0|0.92|1.19|||||A mixed-effect model with treatment as a fixed effect and measurements within participant as repeated measures was performed on the natural ln-transformed parameter.|||1.19|0.92|
72420975|NCT04425902|144353006|OTHER||Ratio of geometric least square mean|1.25|||||TWO_SIDED|90.0|0.96|1.63|||||A mixed-effect model with treatment as a fixed effect and measurements within participant as repeated measures was performed on the natural ln-transformed parameter.|||1.63|0.96|
72420976|NCT04425902|144353009|OTHER||Ratio of geometric least square mean|0.73|||||TWO_SIDED|90.0|0.52|1.03|||||A mixed-effect model with treatment as a fixed effect and measurements within participant as repeated measures was performed on the natural ln-transformed parameter.|||1.03|0.52|
72328954|NCT00803361|144182687|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.03||||0.025|TWO_SIDED|95.0|-11.3|-0.76||p-value is for Severity of Back Pain, Past Week, Change.|ANCOVA|Change = Treatment + Pooled Investigator + Baseline||||-0.76|-11.30|0.025
72420977|NCT04425902|144353010|OTHER||Ratio of geometric least square mean|0.61|||||TWO_SIDED|90.0|0.45|0.82|||||A mixed-effect model with treatment as a fixed effect and measurements within participant as repeated measures was performed on the natural ln-transformed parameter.|||0.82|0.45|
72420978|NCT04425902|144353011|OTHER||Ratio of geometric least square mean|0.78|||||TWO_SIDED|90.0|0.54|1.14|||||A mixed-effect model with treatment as a fixed effect and measurements within participant as repeated measures was performed on the natural ln-transformed parameter.|||1.14|0.54|
72328955|NCT00803361|144182687|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.93||||0.26|TWO_SIDED|95.0|-8.06|2.19||p-value is for Severity of Shoulder Pain, Past Week, Change.|ANCOVA|Change = Treatment + Pooled Investigator + Baseline||||2.19|-8.06|0.260
72420979|NCT04425902|144353117|OTHER||Ratio of geometric least square mean|0.92|||||TWO_SIDED|90.0|0.49|1.71|||||A mixed-effect model with treatment as a fixed effect and measurements within participant as repeated measures was performed on the natural ln-transformed parameter.|||1.71|0.49|
72420980|NCT04425902|144353118|OTHER||Ratio of geometric least square mean|0.93|||||TWO_SIDED|90.0|0.74|1.16|||||A mixed-effect model with treatment as a fixed effect and measurements within participant as repeated measures was performed on the natural ln-transformed parameter.|||1.16|0.74|
72420981|NCT04425902|144353119|OTHER||Ratio of geometric least square mean|0.86|||||TWO_SIDED|90.0|0.43|1.72|||||A mixed-effect model with treatment as a fixed effect and measurements within participant as repeated measures was performed on the natural ln-transformed parameter.|||1.72|0.43|
72420982|NCT04425902|144353122|OTHER||Ratio of geometric least square mean|0.99|||||TWO_SIDED|90.0|0.75|1.29|||||A mixed-effect model with treatment as a fixed effect and measurements within participant as repeated measures was performed on the natural ln-transformed parameter.|||1.29|0.75|
72420983|NCT04425902|144353123|OTHER||Ratio of geometric least square mean|0.99|||||TWO_SIDED|90.0|0.75|1.29|||||A mixed-effect model with treatment as a fixed effect and measurements within participant as repeated measures was performed on the natural ln-transformed parameter.|||1.29|0.75|
72420984|NCT04425902|144353124|OTHER||Ratio of geometric least square mean|0.94|||||TWO_SIDED|90.0|0.73|1.22|||||A mixed-effect model with treatment as a fixed effect and measurements within participant as repeated measures was performed on the natural ln-transformed parameter.|||1.22|0.73|
72420985|NCT04425902|144353127|OTHER||Ratio of geometric least square mean|1.1|||||TWO_SIDED|90.0|0.93|1.3|||||A mixed-effect model with treatment as a fixed effect and measurements within participant as repeated measures was performed on the natural ln-transformed parameter.|||1.30|0.93|
72420986|NCT04425902|144353128|OTHER||Ratio of geometric least square mean|0.99|||||TWO_SIDED|90.0|0.83|1.19|||||A mixed-effect model with treatment as a fixed effect and measurements within participant as repeated measures was performed on the natural ln-transformed parameter.|||1.19|0.83|
72420987|NCT04425902|144353129|OTHER||Ratio of geometric least square mean|1.12|||||TWO_SIDED|90.0|0.88|1.44|||||A mixed-effect model with treatment as a fixed effect and measurements within participant as repeated measures was performed on the natural ln-transformed parameter.|||1.44|0.88|
72420988|NCT04425902|144353132|OTHER||Ratio of geometric least square mean|0.9|||||TWO_SIDED|90.0|0.75|1.09|||||A mixed-effect model with treatment as a fixed effect and measurements within participant as repeated measures was performed on the natural ln-transformed parameter.|||1.09|0.75|
72420989|NCT04425902|144353133|OTHER||Ratio of geometric least square mean|0.91|||||TWO_SIDED|90.0|0.76|1.09|||||A mixed-effect model with treatment as a fixed effect and measurements within participant as repeated measures was performed on the natural ln-transformed parameter.|||1.09|0.76|
72420990|NCT04425902|144353134|OTHER||Ratio of geometric least square mean|0.85|||||TWO_SIDED|90.0|0.65|1.1|||||A mixed-effect model with treatment as a fixed effect and measurements within participant as repeated measures was performed on the natural ln-transformed parameter.|||1.10|0.65|
72420991|NCT02901626|144353151|SUPERIORITY||Risk Ratio (RR)|1.0|||||TWO_SIDED|95.0|0.83|1.2||||||||1.20|0.83|
72420992|NCT02901626|144353152|SUPERIORITY||Median Difference (Net)|2.0|||||TWO_SIDED|95.0|-4.0|8.0||||||||8|-4|
72420993|NCT02901626|144353153|SUPERIORITY||Mean Difference (Net)|-0.1|||||TWO_SIDED|95.0|-1.06|0.8||||||||0.80|-1.06|
72420994|NCT02901626|144353154|SUPERIORITY||Risk Ratio (RR)|1.26|||||TWO_SIDED|95.0|0.92|1.71||||||||1.71|0.92|
72420995|NCT02901626|144353155|SUPERIORITY||Risk Ratio (RR)|1.2|||||TWO_SIDED|95.0|0.93|1.55||||||||1.55|0.93|
72420996|NCT02901626|144353156|SUPERIORITY||Risk Ratio (RR)|1.16|||||TWO_SIDED|95.0|0.93|1.45||||||||1.45|0.93|
72420997|NCT02901626|144353157|SUPERIORITY||Risk Ratio (RR)|1.3|||||TWO_SIDED|95.0|0.92|1.82||||||||1.82|0.92|
72420998|NCT02901626|144353158|SUPERIORITY||Risk Ratio (RR)|0.97|||||TWO_SIDED|95.0|0.79|1.19||||||||1.19|0.79|
72420999|NCT02901626|144353159|SUPERIORITY||Risk Ratio (RR)|1.21|||||TWO_SIDED|95.0|0.61|2.39||||||||2.39|0.61|
72421000|NCT02901626|144353160|SUPERIORITY||Risk Ratio (RR)|1.01|||||TWO_SIDED|95.0|0.79|1.31||||||||1.31|0.79|
72421001|NCT02901626|144353161|SUPERIORITY||Risk Ratio (RR)|1.06|||||TWO_SIDED|95.0|0.55|2.04||||||||2.04|0.55|
72328956|NCT00803361|144182687|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.67||||0.145|TWO_SIDED|95.0|-8.61|1.28||p-value is for Pain Interference, Daily Activities, Change|ANCOVA|Change = Treatment + Pooled Investigator + Baseline||||1.28|-8.61|0.145
72421002|NCT02901626|144353162|SUPERIORITY||Median Difference (Net)|0.0|||||TWO_SIDED|95.0|0.0|0.0||||||||0|0|
72421003|NCT02901626|144353163|SUPERIORITY||Risk Ratio (RR)|1.36|||||TWO_SIDED|95.0|0.95|1.94||||||||1.94|0.95|
72421004|NCT02901626|144353164|SUPERIORITY||Risk Ratio (RR)|1.45|||||TWO_SIDED|95.0|1.0|2.11||||||||2.11|1.00|
72421005|NCT02901626|144353165|SUPERIORITY||Risk Ratio (RR)|1.02|||||TWO_SIDED|95.0|0.88|1.18||||||||1.18|0.88|
72421006|NCT02901626|144353166|SUPERIORITY||Median Difference (Net)|0.0|||||TWO_SIDED|95.0|-12.0|12.0||||||||12|-12|
72421007|NCT02901626|144353167|SUPERIORITY||Risk Ratio (RR)|0.9|||||TWO_SIDED|95.0|0.69|1.17||||||||1.17|0.69|
72421008|NCT02901626|144353168|SUPERIORITY||Median Difference (Net)|1.0|||||TWO_SIDED|95.0|-12.0|14.0||||||||14|-12|
72421009|NCT02901626|144353169|SUPERIORITY||Risk Ratio (RR)|0.98|||||TWO_SIDED|95.0|0.06|15.7||||||||15.7|0.06|
72421010|NCT02901626|144353170|SUPERIORITY||Risk Ratio (RR)|0.82|||||TWO_SIDED|95.0|0.25|2.65||||||||2.65|0.25|
72421011|NCT02901626|144353171|SUPERIORITY||Risk Ratio (RR)|0.56|||||TWO_SIDED|95.0|0.17|1.9||||||||1.90|0.17|
72421012|NCT02901626|144353172|SUPERIORITY||Risk Ratio (RR)|1.15|||||TWO_SIDED|95.0|0.68|1.96||||||||1.96|0.68|
72421013|NCT02901626|144353173|SUPERIORITY||Risk Ratio (RR)|0.95|||||TWO_SIDED|95.0|0.71|1.27||||||||1.27|0.71|
72421014|NCT02901626|144353174|SUPERIORITY||Risk Ratio (RR)|0.72|||||TWO_SIDED|95.0|0.37|1.41||||||||1.41|0.37|
72421015|NCT02901626|144353175|SUPERIORITY||Risk Ratio (RR)|1.14|||||TWO_SIDED|95.0|0.39|3.37||||||||3.37|0.39|
72421016|NCT02901626|144353176|SUPERIORITY||Risk Ratio (RR)|1.0|||||TWO_SIDED|95.0|0.78|1.29||||||||1.29|0.78|
72421017|NCT02901626|144353177|SUPERIORITY||Risk Ratio (RR)|0.8|||||TWO_SIDED|95.0|0.58|1.1||||||||1.10|0.58|
72421018|NCT02901626|144353178|SUPERIORITY||Risk Ratio (RR)|2.45|||||TWO_SIDED|95.0|0.48|12.57||||||||12.57|0.48|
72421019|NCT02901626|144353179|SUPERIORITY||Risk Ratio (RR)|0.65|||||TWO_SIDED|95.0|0.27|1.58||||||||1.58|0.27|
72421020|NCT02901626|144353180|SUPERIORITY||Risk Ratio (RR)|0.67|||||TWO_SIDED|95.0|0.47|0.97||||||||0.97|0.47|
72421021|NCT02901626|144353181|SUPERIORITY||Risk Ratio (RR)|0.49|||||TWO_SIDED|95.0|0.09|2.66||||||||2.66|0.09|
72421022|NCT02901626|144353182|SUPERIORITY||Risk Ratio (RR)|1.05|||||TWO_SIDED|95.0|0.81|1.37||||||||1.37|0.81|
72421023|NCT02901626|144353183|SUPERIORITY||Median Difference (Net)|0.0|||||TWO_SIDED|95.0|0.0|0.0||||||||0|0|
72421024|NCT02901626|144353184|SUPERIORITY||Median Difference (Net)|10.0|||||TWO_SIDED|95.0|-16.0|36.0||||||||36|-16|
72421025|NCT00331344|144353187|OTHER||Dose Level VIa|1.0|||||TWO_SIDED||||||||Dose level VIa (mitoxantrone hydrochloride 12 mg/m2 IV over 30 minutes, ixabepilone 30mg/m2 IV over 3 hours on day 1, pegfilgrastim 6mg SC on day 2, oral prednisone twice daily on days 1-21) was determined to be MTD, based on 1 event of DLT at VIa.|Cohorts of 3 patients will be enrolled at each dose level; if 1 dose limiting toxicity (DLT) is observed then the cohort will be expanded to 6 patients. If a second DLT is observed, the previous dose level will be considered the MTD. If all observed DLT are due to neuropathy (specific to ixabepilone), then we would consider the previous dose level of Ixabepilone the MTD for that drug, and escalate mitoxantrone hydrochloride as described above to a maximum dose of 12 mg/m\^2.||||
72421026|NCT01373931|144353189|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Mean|0.976|||||TWO_SIDED|90.0|0.907|1.05|||Mixed Models Analysis|Ratio of Geometric LS mean is for ethinyl estradiol.||||1.05|0.907|
72421027|NCT01373931|144353189|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Mean|0.914|||||TWO_SIDED|90.0|0.842|0.991|||Mixed Models Analysis|Ratio of Geometric LS mean is for norelgestromin.||||0.991|0.842|
72328957|NCT00803361|144182687|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.15||||0.011|TWO_SIDED|95.0|-12.64|-1.66||p-value is for Pain During Waking Hours, Past Week, Change|ANCOVA|Change = Treatment + Pooled Investigator + Baseline||||-1.66|-12.64|0.011
72328958|NCT00803361|144182688|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.83||||0.068|TWO_SIDED|95.0|-1.72|0.06||p-value is for Change from Baseline|ANCOVA|Change = Treatment + Pooled Investigator + Baseline||||0.06|-1.72|0.068
72421028|NCT01373931|144353190|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.25|||||TWO_SIDED|90.0|-0.73|0.51|||Wilcoxon Signed Rank Test|Median difference is for ethinyl estradiol.||||0.51|-0.73|
72328959|NCT02819297|144182689|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
72328960|NCT01262638|144182728|SUPERIORITY||Difference in Least Squares Means|-15.7|||<|0.0001|TWO_SIDED|95.0|-21.8|-9.7|||ANCOVA|||||-9.7|-21.8|<0.0001
72328961|NCT01262638|144182728|SUPERIORITY||Difference in Least Squares Means|-22.9|||<|0.0001|TWO_SIDED|95.0|-28.9|-16.9|||ANCOVA|||||-16.9|-28.9|<0.0001
72421029|NCT01373931|144353190|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0|||||TWO_SIDED|90.0|-0.5|0.5|||Wilcoxon Signed Rank Test|Median difference is for norelgestromin.||||0.50|-0.50|
72328962|NCT01262638|144182728|SUPERIORITY||Difference in Least Squares Means|-24.5|||<|0.0001|TWO_SIDED|95.0|-30.5|-18.4|||ANCOVA|||||-18.4|-30.5|<0.0001
72328963|NCT00894699|144182746|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Fisher Exact|||||||<0.001
72328964|NCT00894699|144182746|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA|||||||<0.001
72328965|NCT03928418|144182788|SUPERIORITY||Mean Difference (Net)|3.5|||<|0.001|TWO_SIDED|95.0|2.1|4.9||p-value comparing live call booster to SOC arm: p \< 0.001 (calculated)|Mixed Models Analysis|Mixed effects model; random effects for participants; fixed effects for sex, baseline # of drinking days, visit, arm, interaction btwn visit and arm|SOC arm minus live call booster arm reported here.|||4.9|2.1|<0.001
72328966|NCT03928418|144182788|SUPERIORITY||Mean Difference (Net)|3.6|||<|0.001|TWO_SIDED|95.0|2.2|5.1||p-value comparing technology booster to SOC arm: p \< 0.001 (calculated)|Mixed Models Analysis|Mixed effects model; random effects for participants; fixed effects for sex, baseline # of drinking days, visit, arm, interaction btwn visit and arm|SOC arm minus technology booster arm reported here.|||5.1|2.2|<0.001
72328967|NCT03928418|144182789|SUPERIORITY||Mean Difference (Net)|36.4||||0.643|TWO_SIDED|95.0|-117.5|190.3||p-value comparing live call booster arm to SOC arm: p = 0.643|Mixed Models Analysis|Mixed effects model; random effects for participants; fixed effects for sex, baseline PEth level, visit, arm, interaction btwn visit and arm|SOC arm minus live call booster arm reported here.|||190.3|-117.5|0.643
72328968|NCT03928418|144182789|SUPERIORITY||Mean Difference (Net)|-30.9||||0.711|TWO_SIDED|95.0|-194.8|132.9||p-value comparing technology booster arm to SOC arm: p = 0.711|Mixed Models Analysis|Mixed effects model; random effects for participants; fixed effects for sex, baseline PEth level, visit, arm, interaction btwn visit and arm|SOC arm minus technology booster arm reported here.|||132.9|-194.8|0.711
72328969|NCT03928418|144182790|SUPERIORITY||Mean Difference (Net)|-2.3||||0.515|TWO_SIDED|95.0|-9.3|4.7||p-value comparing live call booster arm to SOC: p = 0.515|Regression, Logistic||SOC minus live call booster arm presented here.|||4.7|-9.3|0.515
72421030|NCT01373931|144353191|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Mean|1.07||||||90.0|1.0|1.15|||Mixed Models Analysis|Ratio of Geometric LS mean is for ethinyl estradiol.||||1.15|1.00|
72328970|NCT03928418|144182790|SUPERIORITY||Mean Difference (Net)|-0.9||||0.801|TWO_SIDED|95.0|-8.3|6.4||p-value comparing technology booster arm to SOC: p = 0.801|Regression, Logistic||SOC minus technology booster arm presented here.|||6.4|-8.3|0.801
72328971|NCT03928418|144182791|SUPERIORITY||Mean Difference (Net)|28.9|||<|0.001|TWO_SIDED|95.0|17.0|40.7||p-value comparing live call booster arm to SOC: p \< 0.001 (calculated)|Mixed Models Analysis|Mixed effects model; random effects for participants; fixed effects for sex, baseline alcohol use, visit, arm, interaction btwn visit and arm|SOC minus live call booster arm presented here.|||40.7|17.0|<0.001
72328972|NCT03928418|144182791|SUPERIORITY||Mean Difference (Net)|24.9|||<|0.001|TWO_SIDED|95.0|13.0|36.8||p-value comparing technology booster arm to SOC: p \< 0.001 (calculated)|Mixed Models Analysis|Mixed effects model; random effects for participants; fixed effects for sex, baseline alcohol use, visit, arm, interaction btwn visit and arm|SOC minus technology booster arm presented here.|||36.8|13.0|<0.001
72328973|NCT03928418|144182792|SUPERIORITY||Mean Difference (Net)|4.4||||0.002|TWO_SIDED|95.0|1.6|7.3||p-value comparing live call booster arm to SOC: p = 0.002|Mixed Models Analysis|Mixed effects model; random effects for participants; fixed effects for sex, baseline alcohol use, visit, arm, interaction btwn visit and arm|SOC arm minus live call booster arm presented here.|||7.3|1.6|0.002
72328974|NCT03928418|144182792|SUPERIORITY||Mean Difference (Net)|4.3||||0.003|TWO_SIDED|95.0|1.5|7.2||p-value comparing technology booster arm to SOC: p = 0.003|Mixed Models Analysis|Mixed effects model; random effects for participants; fixed effects for sex, baseline alcohol use, visit, arm, interaction btwn visit and arm|SOC arm minus technology booster arm presented here.|||7.2|1.5|0.003
72328975|NCT03928418|144182794|SUPERIORITY||Mean Difference (Net)|-0.8||||0.61|TWO_SIDED|95.0|-3.8|2.2||p-value comparing live call booster arm to SOC arm: p = 0.610.|Mixed Models Analysis|Mixed effects model; random effects for participants; fixed effects for sex, baseline ART adherence, visit, arm, interaction btwn visit and arm|SOC minus live call booster arm presented here.|||2.2|-3.8|0.610
72328976|NCT03928418|144182794|SUPERIORITY||Mean Difference (Net)|-1.1||||0.474|TWO_SIDED|95.0|-4.1|1.9||p-value comparing technology booster arm to SOC arm: p = 0.474.|Mixed Models Analysis|Mixed effects model; random effects for participants; fixed effects for sex, baseline ART adherence, visit, arm, interaction btwn visit and arm|SOC minus technology booster arm presented here.|||1.9|-4.1|0.474
72328977|NCT00763256|144182805|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||t-test, 2 sided|||The null hypothesis states that there is no difference between groups.||||0.05
72421031|NCT01373931|144353191|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Mean|1.0||||||90.0|0.944|1.07|||Mixed Models Analysis|Ratio of Geometric LS mean is for norelgestromin.||||1.07|0.944|
72328978|NCT00763256|144182806|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||t-test, 2 sided|||The null hypothesis states that there is no difference between groups.||||0.05
72328979|NCT00763256|144182807|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||t-test, 2 sided|||The null hypothesis states that there is no difference between groups.||||0.05
72328980|NCT00763256|144182808|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||t-test, 2 sided|||The null hypothesis states that there is no difference between groups.||||0.05
72328981|NCT00763256|144182809|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||t-test, 2 sided|||The null hypothesis states that there is no difference between groups.||||0.05
72328982|NCT02473471|144182898|OTHER|The sample size was calculated based on a type I error frequency of 5%. According to the power analysis and assuming a large effect size difference between groups (effect size= 0.8), the power analysis yielded 28 subjects per group at a conventional alpha level (p = 0.05) and desired power (1 - β) of 0.90||||||0.77|||||||t-test, 2 sided|||||||0.77
72421032|NCT02228967|144353236|OTHER||||||=|0.274||||||A priori threshold for statistical significance was 0.05|Repeated Measures--General Linear Model|||Data were analyzed using a GLM repeated measures approach. A priori means comparisons tests (usual care vs. SBIRT intervention) with Bonferroni corrections were used to compare mean differences at follow-up.||||=0.274
72421033|NCT02228967|144353237|OTHER||||||=|0.083|||||||Repeated Measures--General Linear Model|||Data were analyzed using a GLM repeated measures approach. A priori means comparisons tests (usual care vs. SBIRT intervention) with Bonferroni corrections were used to compare mean differences at follow-up.||||=0.083
72421034|NCT02228967|144353238|OTHER||||||=|0.028|||||||Repeated Measures--General Linear Model|||Data were analyzed using a GLM repeated measures approach. A priori means comparisons tests (usual care vs. SBIRT intervention) with Bonferroni corrections were used to compare mean differences at follow-up.||||=0.028
72421035|NCT02228967|144353239|OTHER||||||=|0.708|||||||Repeated Measures--General Linear Model|||Data were analyzed using a GLM repeated measures approach. A priori means comparisons tests (usual care vs. SBIRT intervention) with Bonferroni corrections were used to compare mean differences at follow-up.||||=0.708
72421036|NCT02228967|144353240|OTHER||||||=|0.197||||||A priori threshold for statistical significance was 0.05.|Repeated Measures--General Linear Model|||Data were analyzed using a GLM repeated measures approach. A priori means comparisons tets (usual care vs. SBIRT intervention) with Bonferroni corrections were used to compare mean differences at follow-up.||||=0.197
72421037|NCT02228967|144353241|OTHER||||||=|0.023||||||A priori threshold for statistical significance was 0.05.|Repeated Measures--General Linear Model|||Data were analyzed using a GLM repeated measures approach. A priori means comparisons tests (usual care vs. SBIRT intervention) with Bonferroni corrections were used to compare mean differences at follow-up.||||=0.023
72421038|NCT02228967|144353242|OTHER||||||<|0.001||||||A priori threshold for statistical significance was 0.05.|Repeated Measures--General Linear Model|||Data were analyzed using a GLM repeated measures approach. A priori means comparisons tests (usual care vs. SBIRT intervention) with Bonferroni corrections were used to compare mean differences at follow-up.||||<0.001
72421039|NCT02228967|144353243|OTHER||||||=|0.348||||||A priori threshold for statistical significance was 0.05.|Repeated Measures--General Linear Model|||Data were analyzed using a GLM repeated measures approach. A priori means comparison tests (usual care vs. SBIRT intervention) with Bonferroni corrections were used to compare means differences at follow-up.||||=0.348
72421040|NCT02228967|144353244|OTHER||Mean Difference (Final Values)|0.345|STANDARD_ERROR_OF_MEAN|0.203||0.091|TWO_SIDED|||||A priori threshold for statistical significance was 0.05.|Repeated Measures GLM|||Data were analyzed using a GLM repeated measures approach. A priori means comparison tests (usual care vs. SBIRT intervention) with Bonferroni corrections were used to compare means differences at follow-up.||||0.091
72421041|NCT02228967|144353245|OTHER||Mean Difference (Net)|0.393|STANDARD_ERROR_OF_MEAN|0.362||0.278|TWO_SIDED|||||A priori alpha set at 0.05|Repeated Measures GLM|||Data were analyzed using a GLM repeated measures approach. A priori means comparison tests (usual care vs. SBIRT intervention) with Bonferroni corrections were used to compare means differences at follow-up.||||.278
72421042|NCT02228967|144353246|OTHER||Mean Difference (Net)|3.163|STANDARD_ERROR_OF_MEAN|1.44||0.029|TWO_SIDED|||||A priori alpha set at 0.05.|Repeated Measures GLM|||Data were analyzed using a GLM repeated measures approach. A priori means comparison tests (usual care vs. SBIRT intervention) with Bonferroni corrections were used to compare means differences at follow-up.||||0.029
72421043|NCT02228967|144353247|OTHER||Mean Difference (Net)|-0.015||||0.897|TWO_SIDED|||||A priori alpha set at 0.05.|Repeated Measures GLM|||Data were analyzed using a GLM repeated measures approach. A priori means comparison tests (usual care vs. SBIRT intervention) with Bonferroni corrections were used to compare means differences at follow-up.||||0.897
72421044|NCT02228967|144353248|OTHER|||||||0.15|||||||Linear mixed effects|||Linear mixed-effects models were used to analyze 5 pooled datasets derived from multiple imputation for intent to treat analyses.||||0.15
72421045|NCT02228967|144353249|OTHER|||||||0.2||||||A priori alpha set at 0.05.|Linear mixed effects|||Linear mixed-effects models were used to analyze 5 pooled datasets derived from multiple imputation for intent to treat analyses.||||0.20
72421046|NCT02228967|144353250|OTHER|||||||0.38||||||A priori alpha set at 0.05.|Linear mixed effects|||Linear mixed-effects models were used to analyze 5 pooled datasets derived from multiple imputation for intent to treat analyses.||||0.38
72421047|NCT02228967|144353251|OTHER|A priori alpha set at 0.05||||||0.48|||||||Linear mixed effects|||Linear mixed-effects models were used to analyze 5 pooled datasets derived from multiple imputation for intent to treat analyses.||||0.48
72328983|NCT02473471|144182899|OTHER|||||||0.5|||||||t-test, 2 sided|||||||0.50
72328984|NCT02473471|144182900|OTHER|||||||0.76|||||||t-test, 2 sided|||||||0.76
72328985|NCT02473471|144182901|OTHER|||||||0.56|||||||t-test, 2 sided|||||||0.56
72328986|NCT02473471|144182902|OTHER|||||||0.88|||||||t-test, 2 sided|||||||0.88
72328987|NCT02473471|144182903|OTHER|||||||0.74||||||There was no significant difference in tooth movement between control and MOP sides from baseline to 1st, 2nd and 3rd months. P Value \< 0.05 was considered statistically significant.|t-test, 2 sided|||||||0.74
72421048|NCT02228967|144353252|OTHER|A priori alpha set at 0.05.||||||0.09|||||||Linear mixed effects|||Linear mixed-effects models were used to analyze 5 pooled datasets derived from multiple imputation for intent to treat analyses.||||0.09
72421049|NCT02228967|144353253|OTHER|||||||0.08|||||||Linear mixed effects|||A priori alpha set at 0.05||||0.08
72421050|NCT02228967|144353254|OTHER|||||||0.11|||||||Linear mixed effects|||A priori alpha set at 0.05||||0.11
72421051|NCT02228967|144353255|OTHER|||||||0.84|||||||Linear mixed effects|||A priori alpha set at 0.05||||0.84
72421052|NCT02347657|144353260|SUPERIORITY||Least Squares (LS) Mean Difference|4.0|||<|0.0001|TWO_SIDED|95.0|3.1|4.8|||Mixed model for repeated measures (MMRM)|||Testing was performed according to the hierarchical testing procedure to control the overall type I error for tested at α = 0.05.||4.8|3.1|<0.0001
72421053|NCT02347657|144353261|SUPERIORITY||LS mean difference|6.8|||<|0.0001|TWO_SIDED|95.0|5.3|8.3|||MMRM|||Testing was performed according to the hierarchical testing procedure to control the overall type I error for tested at α = 0.05.||8.3|5.3|<0.0001
72421054|NCT02347657|144353262|SUPERIORITY||Event Rate Ratio|0.65||||0.0054|TWO_SIDED|95.0|0.48|0.88|||Negative Binomial Regression|||Testing was performed according to the hierarchical testing procedure to control the overall type I error for tested at α = 0.05.||0.88|0.48|0.0054
72421055|NCT02347657|144353263|SUPERIORITY||LS mean difference|0.06||||0.4127|TWO_SIDED|95.0|-0.08|0.19|||MMRM|||Testing was performed according to the hierarchical testing procedure to control the overall type I error for tested at α = 0.05.||0.19|-0.08|0.4127
72328988|NCT02473471|144182904|OTHER|||||||0.59|||||||t-test, 2 sided|||Root length at baseline.||||0.59
72328989|NCT02473471|144182904|OTHER|||||||0.48|||||||t-test, 2 sided|||Root length at 3 months||||0.48
72328990|NCT02473471|144182905|OTHER|||||||0.388|||||||t-test, 2 sided|||Immediate after intervention||||0.388
72328991|NCT02473471|144182905|OTHER|||||||0.092|||||||t-test, 2 sided|||1 hour after intervention||||0.092
72328992|NCT02473471|144182905|OTHER|||||||0.1|||||||t-test, 2 sided|||12 hour after intervention||||0.100
72328993|NCT02473471|144182905|OTHER|||||||0.302|||||||t-test, 2 sided|||Day 1 after intervention||||0.302
72328994|NCT02473471|144182905|OTHER|||||||0.582|||||||t-test, 2 sided|||Day 3 after intervention||||0.582
72328995|NCT02473471|144182905|OTHER|||||||0.743|||||||t-test, 2 sided|||Day 5 after intervention||||0.743
72328996|NCT02473471|144182905|OTHER|||||||0.809|||||||t-test, 2 sided|||Day 7 after intervention||||0.809
72328997|NCT02473471|144182906|OTHER|||||||0.09|||||||t-test, 2 sided|||Day 1||||0.09
72328998|NCT02473471|144182906|OTHER|||||||0.29|||||||t-test, 2 sided|||Day 3||||0.29
72328999|NCT02473471|144182906|OTHER|||||||0.57|||||||t-test, 2 sided|||Day 5||||0.57
72329000|NCT02473471|144182906|OTHER|||||||0.82|||||||t-test, 2 sided|||Day 7||||0.82
72329001|NCT02473471|144182907|OTHER|||||||0.27|||||||t-test, 2 sided|||Day 1||||0.27
72329002|NCT02473471|144182907|OTHER|||||||0.37|||||||t-test, 2 sided|||Day 3||||0.37
72329003|NCT02473471|144182907|OTHER|||||||0.33|||||||t-test, 2 sided|||Day 5||||0.33
72329004|NCT02473471|144182907|OTHER||||||>|0.05|||||||t-test, 2 sided|||Day 7||||> 0.05
72329005|NCT02473471|144182908|OTHER|||||||0.05|||||||t-test, 2 sided|||Day 1||||0.05
72329006|NCT02473471|144182908|OTHER|||||||0.47|||||||t-test, 2 sided|||Day 3||||0.47
72329007|NCT02473471|144182908|OTHER|||||||0.09|||||||t-test, 2 sided|||Day 5||||0.09
72329008|NCT02473471|144182908|OTHER|||||||0.16|||||||t-test, 2 sided|||||||0.16
72329009|NCT02473471|144182909|OTHER|||||||0.18|||||||t-test, 2 sided|||Day 1||||0.18
72329010|NCT02473471|144182909|OTHER|||||||0.57|||||||t-test, 2 sided|||Day 3||||0.57
72329011|NCT02473471|144182909|OTHER|||||||0.3|||||||t-test, 2 sided|||Day 5||||0.30
72329012|NCT02473471|144182909|OTHER|||||||0.56|||||||t-test, 2 sided|||Day 7||||0.56
72329013|NCT02473471|144182910|OTHER||||||<|0.05|||||||Descriptive statistics|||||||< 0.05
72329014|NCT01625416|144182969|SUPERIORITY|||||||0.05|||||||Chi-squared|Chi square (2) =5.9, p=0.05|||This chi-square analysis was derived from a mixed repeated measures model comparing intervention results with control results over 4 time points.|||0.05
72329015|NCT01625416|144182970|SUPERIORITY|||||||0.69|||||||Chi-squared|Chi square(2) = 0.74, p = 0.69|||This chi-square analysis was derived from a mixed repeated measures model comparing intervention results with control results over 4 time points.|||0.69
72421056|NCT00261495|144353271|NON_INFERIORITY_OR_EQUIVALENCE|Tested using 95% confidence interval approach. The non-inferiority margin was 1.|Mean Difference (Net)|0.29||||0.011||95.0|-0.27|0.84||Statistical significance level was 0.05. Two-sided 95% CI of the treatment difference based on LS means \& error terms obtained from ANCOVA (covariate: baseline; factors: country, previous pain treatment, underlying disease, and treatment).|ANCOVA|If the right side of CI\<1 then the null hypothesis was rejected in favour of the alternative, and non-inferiority of OROS hydromorphone was concluded.|LS mean difference has been presented, which was calculated as hydromorphone minus oxycodone.|"Null hypothesis: Difference in change from baseline with OROS hydromorphone compared with SR oxycodone was less than or equal to 1.~Alternative hypothesis: Difference in change from baseline with OROS hydromorphone compared with SR oxycodone was greater than 1.~Sample size needed to detect a clinically significant difference of 1 was 151 per treatment arm (standard deviation = 2.4, significance level 0.025 one-sided, based on 90% power)."||0.84|-0.27|0.011
72421057|NCT00261495|144353272|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.08||||0.706||95.0|-0.32|0.47||A two-sided significance level of 0.05 was used. A closed hierarchical testing procedure was used to control the overall Type I error. Procedure was stopped here, subsequent tests were exploratory in nature.|ANCOVA|Superiority of OROS hydromorphone compared to SR oxycodone was evaluated.|Mean difference calculated: hydromorphone minus oxycodone|"Null hypothesis: Difference in change from baseline between hydromorphone and oxycodone was equal to zero.~Alternative hypothesis: Difference in change from baseline between hydromorphone and oxycodone was not equal to zero."||0.47|-0.32|0.706
72421058|NCT00261495|144353273|NON_INFERIORITY_OR_EQUIVALENCE|Tested using 95% confidence interval approach. The non-inferiority margin was 1.|Mean Difference (Net)|-0.12|||<|0.001||95.0|-0.53|0.29||Statistical significance level was 0.05. Two-sided 95% CI of the treatment difference based on LS means \& error terms obtained from ANCOVA (covariate: baseline; factors: country, previous pain treatment, underlying disease, and treatment).|ANCOVA|If the right side of CI\<1 then the null hypothesis was rejected in favour of the alternative, and non-inferiority of OROS hydromorphone was concluded.|Mean difference calculated: hydromorphone minus oxycodone|"Null hypothesis: Difference in change from baseline with OROS hydromorphone compared with SR oxycodone was less than or equal to 1.~Alternative hypothesis: Difference in change from baseline with OROS hydromorphone compared with SR oxycodone was greater than 1.~Sample size needed to detect a clinically significant difference of 1 was 151 per treatment arm (standard deviation = 2.4, significance level 0.025 one-sided, based on 90% power)."||0.29|-0.53|<0.001
72421059|NCT00261495|144353274|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.87||||0.065||95.0|-5.94|0.19||A two-sided significance level of 0.05 was used. A closed hierarchical testing procedure was used to control the overall Type I error. Procedure has been stopped, test is exploratory in nature.|ANCOVA|Superiority of OROS hydromorphone compared to SR oxycodone was evaluated.|Mean difference calculated: hydromorphone minus oxycodone|"Null hypothesis: Difference in change from baseline between hydromorphone and oxycodone was equal to zero.~Alternative hypothesis: Difference in change from baseline between hydromorphone and oxycodone was not equal to zero."||0.19|-5.94|0.065
72421060|NCT00261495|144353275|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.2||||0.348||95.0|-0.62|0.22||A two-sided significance level of 0.05 was used. A closed hierarchical testing approach was used to control the overall Type I error. Procedure has been stopped, test is exploratory in nature.|ANCOVA|Superiority of OROS hydromorphone compared to SR oxycodone was evaluated.|Mean difference was calculated: hydromorphone minus oxycodone|"Null hypothesis: Difference in change from baseline between hydromorphone and oxycodone was equal to zero.~Alternative hypothesis: Difference in change from baseline between hydromorphone and oxycodone was not equal to zero."||0.22|-0.62|0.348
72421061|NCT00261495|144353276|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.11||||0.616||95.0|-0.54|0.32||A two-sided significance level of 0.05 was used. A closed hierarchical testing approach was used to control the overall Type I error. Procedure has been stopped, test is exploratory in nature.|ANCOVA|Superiority of OROS hydromorphone compared to SR oxycodone was evaluated.|Mean difference was calculated: hydromorphone minus oxycodone|"Null hypothesis: Difference in change from baseline between hydromorphone and oxycodone was equal to zero.~Alternative hypothesis: Difference in change from baseline between hydromorphone and oxycodone was not equal to zero."||0.32|-0.54|0.616
72421062|NCT00261495|144353277|SUPERIORITY_OR_OTHER|||||||0.249||||||A two-sided significance level of 0.05 was used. A closed hierarchical testing approach was used to control the overall Type I error. Hierarchical testing procedure has been stopped, test is exploratory in nature.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel Chi-squared statistic stratified for country was used.||"Null hypothesis: There is no association between study medication and dose escalation.~Alternative hypothesis: There is an association between study medication and dose escalation."||||0.249
72421063|NCT00261495|144353278|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.42||||0.05||95.0|0.0|0.84||0.05 two-sided testing, exploratory comparison|ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison||0.84|-0.00|0.050
72421064|NCT00261495|144353279|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.3||||0.105||95.0|-0.06|0.67||0.05 two-sided test|ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison||0.67|-0.06|0.105
72421065|NCT00261495|144353280|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.39||||0.058||95.0|-0.01|0.79||0.05 two-sided test|ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison||0.79|-0.01|0.058
72421066|NCT00261495|144353281|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.23||||0.21||95.0|-0.13|0.59||0.05 two-sided test|ANCOVA||Mean difference calculated: hdromorphone minus oxycodone|Exploratory comparison||0.59|-0.13|0.210
72421067|NCT00261495|144353282|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.18||||0.941||95.0|-4.87|4.52||0.05 two-sided test|ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison||4.52|-4.87|0.941
72421068|NCT00261495|144353283|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.31||||0.073||95.0|-0.03|0.65||0.05 two-sided test|ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison||0.65|-0.03|0.073
72329016|NCT01625416|144182973|SUPERIORITY|||||||0.97||||||Chi square (2) = 0.06, p = 0.97|Chi-squared||||This chi-square analysis was derived from a mixed repeated measures model comparing intervention results with control results over 4 time points.|||0.97
72421069|NCT00261495|144353284|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.15||||0.431||95.0|-0.52|0.22||0.05 two-sided test|ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison||0.22|-0.52|0.431
72421070|NCT00261495|144353285|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.04||||0.835||95.0|-0.4|0.33||0.05 two-sided test|ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison||0.33|-0.40|0.835
72421071|NCT00261495|144353286|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.51||||0.837||95.0|-5.36|4.35||0.05 two-sided test|ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison||4.35|-5.36|0.837
72421072|NCT00261495|144353287|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.04||||0.832||95.0|-0.38|0.31||0.05 two-sided test|ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison||0.31|-0.38|0.832
72329017|NCT01625416|144182974|SUPERIORITY|||||||0.71|||||||Chi-squared|Chi-Square (2) =0.68, p=0.71|||This chi-square analysis was derived from a mixed repeated measures model comparing intervention results with control results over 4 time points.|||0.71
72329018|NCT02311881|144183033|SUPERIORITY_OR_OTHER||LS mean difference|-2.51||||0.1626|TWO_SIDED|95.0|-6.037|1.016|||ANCOVA||LS treatment means from mixed model analysis of covariance with treatment, target joint and center pools as fixed effects and baseline as a covariate.|"H0: There is no significant difference in mean change from baseline through week 12 of WOMAC Pain between twice daily Paracetamol 1000 mg SR tablets and placebo.~H1: There is a significant difference in mean change from baseline through week 12 of WOMAC Pain between twice daily Paracetamol 1000 mg SR tablets and placebo."||1.016|-6.037|0.1626
72329019|NCT02311881|144183033|NON_INFERIORITY_OR_EQUIVALENCE|Paracetamol 2000mg BID is non-inferior to Paracetamol 1330mg TID if the upper bound of the 95% confidence Interval is less than 5.3.|LS mean difference|-2.36|||||TWO_SIDED|95.0|-5.894|1.166|||ANCOVA||LS treatment means from mixed model analysis of covariance with treatment, target joint and center pools as fixed effects and baseline as a covariate.|"H0: Difference in mean change from baseline through week 12 of WOMAC Pain between Paracetamol 1000 mg SR tablet and Paracetamol 665 mg SR tablet is ≤ - 5.3 (inferiority).~H1: Difference in mean change from baseline through week 12 of WOMAC Pain between Paracetamol 1000 mg SR tablet and Paracetamol 665 mg SR tablet is \> - 5.3 (noninferiority)."||1.166|-5.894|
72329020|NCT02311881|144183033|SUPERIORITY_OR_OTHER||LS mean difference|-0.15||||0.9352|TWO_SIDED|95.0|-3.687|3.394|||ANCOVA||LS treatment means from mixed model analysis of covariance with treatment, target joint and center pools as fixed effects and baseline as a covariate.|"H0: There is no significant difference in mean change from baseline through week 12 of WOMAC Pain between Paracetamol 665 mg SR tablets and placebo.~H1: There is a significant difference in mean change from baseline through week 12 of WOMAC Pain between Paracetamol 665 mg SR tablets and placebo."||3.394|-3.687|0.9352
72329021|NCT00819156|144183043|SUPERIORITY_OR_OTHER_LEGACY||Percentage|61.0||||||95.0|41.0|78.0|||||The estimated value is the percentage of patients with Testosterone \<=0.5 nanograms/milliliter from Day 28 to Day 364. The 95% Confidence Interval was calculated by the Clopper-Pearson method.|||78|41|
72329022|NCT00819156|144183043|SUPERIORITY_OR_OTHER_LEGACY||Percentage|84.0||||||95.0|64.0|95.0|||||The estimated value is the percentage of patients with Testosterone \<=0.5 nanograms/milliliter from Day 28 to Day 364. The 95% Confidence Interval was calculated by the Clopper-Pearson method.|||95|64|
72329023|NCT00819156|144183043|SUPERIORITY_OR_OTHER_LEGACY||Percentage|96.0||||||95.0|81.0|100.0|||||The estimated value is the percentage of patients with Testosterone \<=0.5 nanograms/milliliter from Day 28 to Day 364. The 95% Confidence Interval was calculated by the Clopper-Pearson method.|||100|81|
72329024|NCT00819156|144183043|SUPERIORITY_OR_OTHER_LEGACY||Percentage|90.0||||||95.0|73.0|98.0|||||The estimated value is the percentage of patients with Testosterone \<=0.5 nanograms/milliliter from Day 28 to Day 364. The 95% Confidence Interval was calculated by the Clopper-Pearson method.|||98|73|
72329025|NCT00819156|144183043|SUPERIORITY_OR_OTHER_LEGACY||Percentage|90.0||||||95.0|73.0|98.0|||||The estimated value is the percentage of patients with Testosterone \<=0.5 nanograms/milliliter from Day 28 to Day 364. The 95% Confidence Interval was calculated by the Clopper-Pearson method.|||98|73|
72329026|NCT00819156|144183043|SUPERIORITY_OR_OTHER_LEGACY||Percentage|92.0||||||95.0|74.0|99.0|||||The estimated value is the percentage of patients with Testosterone \<=0.5 nanograms/milliliter from Day 28 to Day 364. The 95% Confidence Interval was calculated by the Clopper-Pearson method.|||99|74|
72329027|NCT00819156|144183044|SUPERIORITY_OR_OTHER_LEGACY||Percentage|92.0||||||95.0|80.0|98.0|||||The estimated value is the percentage of patients with Testosterone (T) \<=0.5 nanograms (ng)/milliliter (mL) from Day 28 to Day 364 for Patients With T \<=0.5 ng/mL at Day 28. The 95% Confidence Interval was calculated by the Clopper-Pearson method.|||98|80|
72329028|NCT00819156|144183044|SUPERIORITY_OR_OTHER_LEGACY||Percentage|96.0||||||95.0|86.0|100.0|||||The estimated value is the percentage of patients with Testosterone (T) \<=0.5 nanograms (ng)/milliliter (mL) from Day 28 to Day 364 for Patients With T \<=0.5 ng/mL at Day 28. The 95% Confidence Interval was calculated by the Clopper-Pearson method.|||100|86|
72329029|NCT00819156|144183044|SUPERIORITY_OR_OTHER_LEGACY||Percentage|100.0||||||95.0|93.0|100.0|||||The estimated value is the percentage of patients with Testosterone (T) \<=0.5 nanograms (ng)/milliliter (mL) from Day 28 to Day 364 for Patients With T \<=0.5 ng/mL at Day 28. The 95% Confidence Interval was calculated by the Clopper-Pearson method.|||100|93|
72329030|NCT00819156|144183045|SUPERIORITY_OR_OTHER_LEGACY||Percentage|70.0||||||95.0|51.0|85.0|||||The estimated value is the percentage of patients with Testosterone \<=0.5 nanograms/milliliter at Day 28. The 95% Confidence Interval was calculated with the Clopper-Pearson method.|||85|51|
72329031|NCT00819156|144183045|SUPERIORITY_OR_OTHER_LEGACY||Percentage|91.0||||||95.0|75.0|98.0|||||The estimated value is the percentage of patients with Testosterone \<=0.5 nanograms/milliliter at Day 28. The 95% Confidence Interval was calculated with the Clopper-Pearson method.|||98|75|
72329032|NCT00819156|144183045|SUPERIORITY_OR_OTHER_LEGACY||Percentage|97.0||||||95.0|84.0|100.0|||||The estimated value is the percentage of patients with Testosterone \<=0.5 nanograms/milliliter at Day 28. The 95% Confidence Interval was calculated with the Clopper-Pearson method.|||100|84|
72329033|NCT00819156|144183045|SUPERIORITY_OR_OTHER_LEGACY||Percentage|97.0||||||95.0|83.0|100.0|||||The estimated value is the percentage of patients with Testosterone \<=0.5 nanograms/milliliter at Day 28. The 95% Confidence Interval was calculated with the Clopper-Pearson method.|||100|83|
72329034|NCT00819156|144183045|SUPERIORITY_OR_OTHER_LEGACY||Percentage|94.0||||||95.0|80.0|99.0|||||The estimated value is the percentage of patients with Testosterone \<=0.5 nanograms/milliliter at Day 28. The 95% Confidence Interval was calculated with the Clopper-Pearson method.|||99|80|
72329035|NCT00819156|144183045|SUPERIORITY_OR_OTHER_LEGACY||Percentage|93.0||||||95.0|77.0|99.0|||||The estimated value is the percentage of patients with Testosterone \<=0.5 nanograms/milliliter at Day 28. The 95% Confidence Interval was calculated with the Clopper-Pearson method.|||99|77|
72329036|NCT00819156|144183046|SUPERIORITY_OR_OTHER_LEGACY||Percentage|83.0||||||95.0|65.0|94.0|||||The estimated value is the percentage of patients with Testosterone \<=0.5 nanograms/milliliter at Day 3. The 95% Confidence Interval was calculated with the Clopper-Pearson method.|||94|65|
72329037|NCT00819156|144183046|SUPERIORITY_OR_OTHER_LEGACY||Percentage|94.0||||||95.0|79.0|99.0|||||The estimated value is the percentage of patients with Testosterone \<=0.5 nanograms/milliliter at Day 3. The 95% Confidence Interval was calculated with the Clopper-Pearson method.|||99|79|
72329038|NCT00819156|144183046|SUPERIORITY_OR_OTHER_LEGACY||Percentage|87.0||||||95.0|70.0|96.0|||||The estimated value is the percentage of patients with Testosterone \<=0.5 nanograms/milliliter at Day 3. The 95% Confidence Interval was calculated with the Clopper-Pearson method.|||96|70|
72329039|NCT00819156|144183046|SUPERIORITY_OR_OTHER_LEGACY||Percentage|93.0||||||95.0|78.0|99.0|||||The estimated value is the percentage of patients with Testosterone \<=0.5 nanograms/milliliter at Day 3. The 95% Confidence Interval was calculated with the Clopper-Pearson method.|||99|78|
72329040|NCT00819156|144183046|SUPERIORITY_OR_OTHER_LEGACY||Percentage|91.0||||||95.0|76.0|98.0|||||The estimated value is the percentage of patients with Testosterone \<=0.5 nanograms/milliliter at Day 3. The 95% Confidence Interval was calculated with the Clopper-Pearson method.|||98|76|
72329041|NCT00819156|144183046|SUPERIORITY_OR_OTHER_LEGACY||Percentage|93.0||||||95.0|78.0|99.0|||||The estimated value is the percentage of patients with Testosterone \<=0.5 nanograms/milliliter at Day 3. The 95% Confidence Interval was calculated with the Clopper-Pearson method.|||99|78|
72329042|NCT00819156|144183047|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0933||95.0|||||Log Rank|||||||0.0933
72329043|NCT00819156|144183048|SUPERIORITY_OR_OTHER_LEGACY|||||||0.165||95.0|||||Log Rank|||||||0.165
72329044|NCT00819156|144183049|SUPERIORITY_OR_OTHER_LEGACY|||||||0.429||95.0|||||Log Rank|||||||0.429
72329045|NCT01575808|144183066|SUPERIORITY_OR_OTHER_LEGACY||Percentage|91.0|||<|0.0001|ONE_SIDED|95.0|86.3||||z-test|One-sided z-test||A literature-based Surgical Bypass Efficacy Goal of 65% was compared to the percentage of subjects maintaining primary assisted patency at 12 months. A one-sided z-test using a Type I error of 5% was performed to test the hypotheses that the 12-month primary assisted patency probability of GP1101 is superior to the SBEG of 65%.|||86.3|<0.0001
72329046|NCT01575808|144183067|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||Hypothesis is that the post-procedure hospital stay duration for GP1101 is superior to the post-procedure hospital stay for the retrospective surgical bypass group.||||<0.0001
72329047|NCT01575808|144183068|SUPERIORITY_OR_OTHER_LEGACY||Percentage|100.0|||<|0.0001|TWO_SIDED|95.0|96.5|100.0|||Fisher Exact||Confidence interval calculated with binomial exact method.|The hypothesis is that the rate of avoidance of general anesthesia for GP1101 is superior to the rate of avoidance of general anesthesis for the retrospective surgical bypass group.||100|96.5|<0.0001
72329048|NCT01575808|144183069|SUPERIORITY_OR_OTHER_LEGACY||Percentage|100.0|||||TWO_SIDED|95.0|96.5|100.0|||||Confidence intervals calculated using the binomial exact method.|||100.0|96.5|
72329049|NCT01575808|144183099|OTHER||Percentage|97.1|||||TWO_SIDED|95.0|91.7|99.4||||||||99.4|91.7|
72329050|NCT01575808|144183119|OTHER||Percentage|100.0|||||TWO_SIDED|95.0|96.5|100.0|||||Confidence Interval calculated with binomial exact method.|||100.0|96.5|
72329051|NCT02263326|144183133|NON_INFERIORITY|We considered DTG/3TC was noninferior to cART if the 90% confidence interval for the difference in proportions, calculated with Miettinen-Nurminen (score) confidence limits, excluded the 12% noninferiority margin.|Risk Difference (RD)|0.0015|||||TWO_SIDED|90.0|-0.098|0.102||||||A sample size of 41 participants per arm provided 80% power to show noninferiority of DTG/3TC to cART based on a 12% noninferiority margin, assuming an estimated treatment failure rate of 5% per arm by week 24 and 5% 1-sided type I error rate.||0.102|-0.098|
72329052|NCT02263326|144183134|NON_INFERIORITY|The difference in virologic outcomes based on the FDA snapshot algorithm at week 48 (HIV RNA \<50 copies/mL) was compared between arms, with 95% confidence intervals.|Risk Difference (RD)|0.02|||||TWO_SIDED|95.0|-0.126|0.165||||||||0.165|-0.126|
72329053|NCT02263326|144183135|OTHER|||||||0.866|||||||Wilcoxon (Mann-Whitney)|||||||0.866
72329054|NCT02263326|144183136|OTHER|||||||0.613|||||||Wilcoxon (Mann-Whitney)|||||||0.613
72329055|NCT02263326|144183137|OTHER|||||||0.42|||||||Wilcoxon (Mann-Whitney)|||||||0.420
72329056|NCT02263326|144183138|OTHER|||||||0.074|||||||Wilcoxon (Mann-Whitney)|||||||0.074
72329057|NCT02263326|144183140|OTHER||Mean Difference (Final Values)|0.5||||0.76|TWO_SIDED|95.0|-3.0|4.1|||Regression, Linear|||||4.1|-3.0|0.76
72329058|NCT01893411|144183141|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean difference|-0.04|||=|0.65|TWO_SIDED|95.0|-0.23|0.14|||Mixed Model Repeated Measure|||||0.14|-0.23|= 0.65
72329059|NCT01893411|144183141|SUPERIORITY_OR_OTHER_LEGACY||LS-Mean difference|-0.04|||=|0.741|TWO_SIDED|95.0|-0.26|0.18|||Mixed Model Repeated Measure|||||0.18|-0.26|= 0.741
72329060|NCT01893411|144183142|SUPERIORITY_OR_OTHER_LEGACY||LS-Mean difference|0.16|||=|0.075|TWO_SIDED|95.0|-0.02|0.34|||Mixed Model Repeated Measure|||||0.34|-0.02|= 0.075
72329061|NCT01893411|144183142|SUPERIORITY_OR_OTHER_LEGACY||LS-Mean difference|0.06|||=|0.603|TWO_SIDED|95.0|-0.16|0.27|||Mixed Model Repeated Measure|||||0.27|-0.16|= 0.603
72329062|NCT02397915|144183160|SUPERIORITY_OR_OTHER||||||<|0.001||||||Par. preferences were analyzed using Prescott's test, as approximated by a Cochran-Mantel-Haenszel test, adjusted for country and symptomatology. All preference p-values were also adjusted for multiplicity using Hochberg's method.|Cochran-Mantel-Haenszel|||||||<0.001
72329063|NCT02397915|144183161|SUPERIORITY_OR_OTHER|||||||0.065||||||Par. preferences were analyzed using Prescott's test, as approximated by a CMH test, adjusted for ctry and sym. All preference p-values were also adjusted for multiplicity using Hochberg's method. P-value is for product attribute scent/odor.|Cochran-Mantel-Haenszel|||||||0.065
72329064|NCT02397915|144183161|SUPERIORITY_OR_OTHER|||||||0.532||||||Par. preferences were analyzed using Prescott's test, as approximated by a CMH test, adjusted for ctry and sym. All preference p-values were also adjusted for multiplicity using Hochberg's method. P-value is for product attribute immediate taste.|Cochran-Mantel-Haenszel|||||||0.532
72329065|NCT02397915|144183161|SUPERIORITY_OR_OTHER|||||||0.138||||||Par. preferences were analyzed using Prescott's test, as approximated by a CMH test, adjusted for ctry and sym. All preference p-values were also adjusted for multiplicity using Hochberg's method. P-value is for product attribute after taste.|Cochran-Mantel-Haenszel|||||||0.138
72329066|NCT02397915|144183161|SUPERIORITY_OR_OTHER||||||<|0.001||||||Par. preferences were analyzed using Prescott's test, as approximated by a CMH test, adjusted for ctry and sym. All preference p-values were also adjusted for multiplicity using Hochberg's method. P-value is for product attribute LDTT.|Cochran-Mantel-Haenszel|||||||<0.001
72329067|NCT02397915|144183161|SUPERIORITY_OR_OTHER|||||||0.017||||||Par. preferences were analyzed using Prescott's test, as approximated by a CMH test, adjusted for ctry and sym. All preference p-values were also adjusted for multiplicity using Hochberg's method. P-value is for product attribute LRON.|Cochran-Mantel-Haenszel|||||||0.017
72329068|NCT02397915|144183161|SUPERIORITY_OR_OTHER|||||||0.046||||||Par. preferences were analyzed using Prescott's test, as approximated by a CMH test, adjusted for ctry and sym. All preference p-values were also adjusted for multiplicity using Hochberg's method. P-value is for product attribute more soothing.|Cochran-Mantel-Haenszel|||||||0.046
72329069|NCT02397915|144183161|SUPERIORITY_OR_OTHER||||||<|0.001||||||Par. preferences were analyzed using Prescott's test, as approximated by a CMH test, adjusted for ctry and sym. All preference p-values were also adjusted for multiplicity using Hochberg's method. P-value is for product attribute less irritating.|Cochran-Mantel-Haenszel|||||||<0.001
72329070|NCT02397915|144183161|SUPERIORITY_OR_OTHER|||||||0.532||||||Par. preferences were analyzed using Prescott's test, as approximated by a CMH test, adjusted for ctry and sym. All preference p-values were also adjusted for multiplicity using Hochberg's method. P-value is for product attribute UTS.|Cochran-Mantel-Haenszel|||||||0.532
72329071|NCT02397915|144183162|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||1||||||Analyzed using an ANOVA mixed model with par. as random effect, ctry, tmt, BL rhinitis sym subgrp, and tmt seq as main effects. P-values for all immediate attribute rating scores adjusted for multiplicity using Hochberg's method.|Cochran-Mantel-Haenszel|||||||1.000
72329072|NCT02397915|144183163|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||1||||||Analyzed using an ANOVA mixed model with par. as random effect, ctry, tmt, BL rhinitis sym subgrp, and tmt seq as main effects. P-values for all immediate attribute rating scores adjusted for multiplicity using Hochberg's method.|Cochran-Mantel-Haenszel|||||||1.00
72329073|NCT02397915|144183164|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||1||||||Analyzed using an ANOVA mixed model with par. as random effect, ctry, tmt, BL rhinitis sym subgrp, and tmt seq as main effects. P-values for all immediate attribute rating scores adjusted for multiplicity using Hochberg's method.|Cochran-Mantel-Haenszel|||||||1.00
72329074|NCT02397915|144183165|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.179||||||Analyzed using an ANOVA mixed model with par. as random effect, ctry, tmt, BL rhinitis sym subgrp, and tmt seq as main effects. P-values for all immediate attribute rating scores adjusted for multiplicity using Hochberg's method.|Cochran-Mantel-Haenszel|||||||0.179
72329075|NCT02397915|144183166|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||1||||||Analyzed using an ANOVA mixed model with par. as random effect, ctry, tmt, BL rhinitis sym subgrp, and tmt seq as main effects. P-values for all immediate attribute rating scores adjusted for multiplicity using Hochberg's method.|Cochran-Mantel-Haenszel|||||||1.00
72329076|NCT02397915|144183167|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0|||<|0.001||||||Analyzed using an ANOVA mixed model with par. as random effect, ctry, tmt, BL rhinitis sym subgrp, and tmt seq as main effects. P-values for all immediate attribute rating scores adjusted for multiplicity using Hochberg's method.|Cochran-Mantel-Haenszel|||||||<0.001
72329077|NCT02397915|144183168|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0|||<|0.001||||||Analyzed using an ANOVA mixed model with par. as random effect, ctry, tmt, BL rhinitis sym subgrp, and tmt seq as main effects. P-values for all immediate attribute rating scores adjusted for multiplicity using Hochberg's method.|Cochran-Mantel-Haenszel|||||||<0.001
72329078|NCT02397915|144183169|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||1||||||Analyzed using an ANOVA mixed model with par. as random effect, ctry, tmt, BL rhinitis sym subgrp, and tmt seq as main effects. P-values for all immediate attribute rating scores adjusted for multiplicity using Hochberg's method.|Cochran-Mantel-Haenszel|||||||1.000
72329079|NCT02397915|144183170|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.188||||||Analyzed using an ANOVA mixed model with par. as random effect, ctry, tmt, BL rhinitis sym subgrp, and tmt seq as main effects. P-values for all immediate attribute rating scores adjusted for multiplicity using Hochberg's method.|Cochran-Mantel-Haenszel|||||||0.188
72329080|NCT02397915|144183171|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.951||||||Analyzed using an ANOVA mixed model with par. as random effect, ctry, tmt, BL rhinitis sym subgrp, and tmt seq as main effects. P-values for all delayed attribute rating scores adjusted for multiplicity using Hochberg's method.|Cochran-Mantel-Haenszel|||||||0.951
72421073|NCT00261495|144353288|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.3||||0.143||95.0|-0.1|0.71||0.05 two-sided test|ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison||0.71|-0.10|0.143
72421074|NCT00261495|144353289|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.21||||0.345||95.0|-0.23|0.64||0.05 two-sided test|ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison||0.64|-0.23|0.345
72421075|NCT00261495|144353290|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.14||||0.552||95.0|-0.33|0.61||0.05 two-sided test|ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison||0.61|-0.33|0.552
72329081|NCT02397915|144183172|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.951||||||Analyzed using an ANOVA mixed model with par. as random effect, ctry, tmt, BL rhinitis sym subgrp, and tmt seq as main effects. P-values for all delayed attribute rating scores adjusted for multiplicity using Hochberg's method.|Cochran-Mantel-Haenszel|||||||0.951
72329082|NCT02397915|144183173|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.951||||||Analyzed using an ANOVA mixed model with par. as random effect, ctry, tmt, BL rhinitis sym subgrp, and tmt seq as main effects. P-values for all delayed attribute rating scores adjusted for multiplicity using Hochberg's method.|Cochran-Mantel-Haenszel|||||||0.951
72329083|NCT02397915|144183174|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.004||||||Analyzed using an ANOVA mixed model with par. as random effect, ctry, tmt, BL rhinitis sym subgrp, and tmt seq as main effects. P-values for all delayed attribute rating scores adjusted for multiplicity using Hochberg's method.|Cochran-Mantel-Haenszel|||||||0.004
72329084|NCT02397915|144183175|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.223||||||Analyzed using an ANOVA mixed model with par. as random effect, ctry, tmt, BL rhinitis sym subgrp, and tmt seq as main effects. P-values for all delayed attribute rating scores adjusted for multiplicity using Hochberg's method.|Cochran-Mantel-Haenszel|||||||0.223
72329085|NCT02397915|144183176|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0|||<|0.001||||||Analyzed using an ANOVA mixed model with par. as random effect, ctry, tmt, BL rhinitis sym subgrp, and tmt seq as main effects. P-values for all delayed attribute rating scores adjusted for multiplicity using Hochberg's method.|Cochran-Mantel-Haenszel|||||||<0.001
72329086|NCT02397915|144183177|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.008||||||Analyzed using an ANOVA mixed model with par. as random effect, ctry, tmt, BL rhinitis sym subgrp, and tmt seq as main effects. P-values for all delayed attribute rating scores adjusted for multiplicity using Hochberg's method.|Cochran-Mantel-Haenszel|||||||0.008
72329087|NCT02397915|144183178|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.831||||||Analyzed using an ANOVA mixed model with par. as random effect, ctry, tmt, BL rhinitis sym subgrp, and tmt seq as main effects. P-values for all delayed attribute rating scores adjusted for multiplicity using Hochberg's method.|Cochran-Mantel-Haenszel|||||||0.831
72329088|NCT02397915|144183179|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0|||<|0.001||||||Analyzed using an ANOVA mixed model with par. as random effect, ctry, tmt, BL rhinitis sym subgrp, and tmt seq as main effects. P-values for all delayed attribute rating scores adjusted for multiplicity using Hochberg's method.|Cochran-Mantel-Haenszel|||||||<0.001
72329089|NCT02397915|144183180|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.007||||||Analyzed using an ANOVA mixed model with par. as random effect, ctry, tmt, BL rhinitis sym subgrp, and tmt seq as main effects. P-values for all delayed attribute rating scores adjusted for multiplicity using Hochberg's method.|Cochran-Mantel-Haenszel|||||||0.007
72329090|NCT02397915|144183181|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.568||||||Analyzed using an ANOVA mixed model with par. as random effect, ctry, tmt, BL rhinitis sym subgrp, and tmt seq as main effects. P-values for all delayed attribute rating scores adjusted for multiplicity using Hochberg's method.|Cochran-Mantel-Haenszel|||||||0.568
72329091|NCT02397915|144183182|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.951||||||Analyzed using an ANOVA mixed model with par. as random effect, ctry, tmt, BL rhinitis sym subgrp, and tmt seq as main effects. P-values for all delayed attribute rating scores adjusted for multiplicity using Hochberg's method.|Cochran-Mantel-Haenszel|||||||0.951
72329092|NCT03292874|144183184|SUPERIORITY|||||||0.014||||||"Areas under the receiver operating characteristics curve (AUC) were compared between models with standard and high-resolution MRI variables using the nonparametric method described by DeLong.~DeLong. Biometrics 1988;44(3):837-45."|nonparametric method|||||||0.014
72329093|NCT03053440|144183215|SUPERIORITY||Risk Difference (RD)|10.2||||0.0921|TWO_SIDED|95.0|-1.5|22.0|||Cochran-Mantel-Haenszel|Based on Cochran-Mantel-Haenszel test stratified by the stratification factors per interactive response technology (IRT). p value is 2-sided||||22.0|-1.5|0.0921
72421076|NCT00261495|144353291|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.47||||0.042||95.0|0.02|0.93||0.05 two-sided test|ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison||0.93|0.02|0.042
72421077|NCT00261495|144353292|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.33||||0.171||95.0|-0.14|0.81||0.05 two-sided test|ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison||0.81|-0.14|0.171
72421078|NCT00261495|144353293|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.17||||0.475||95.0|-0.31|0.65||0.05 two-sided test|ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison||0.65|-0.31|0.475
72421079|NCT00261495|144353294|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.23||||0.359||95.0|-0.26|0.72||0.05 two-sided test|ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison||0.72|-0.26|0.359
72421080|NCT00261495|144353295|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.11||||0.611||95.0|-0.52|0.3||0.05 two-sided test|ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison||0.30|-0.52|0.611
72329094|NCT01701362|144183254|SUPERIORITY_OR_OTHER_LEGACY||least squares mean difference|-0.22|STANDARD_ERROR_OF_MEAN|0.16||0.1823||95.0|-0.54|0.1|||Mixed Model Repeated Measures Analysis|Mixed Model Repeated Measures = MMRM|MMRM analysis includes fixed categorical effects of treatment, country, trauma type, visit week, treatment-by-visit interaction, and fixed continuous effect of baseline value. Missing mean pain scores imputed by multiple imputation method|||0.10|-0.54|0.1823
72329095|NCT01701362|144183255|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0012||||||The p-value is derived from CMH test, stratified for pooled center and trauma type and excludes missing values.|Cochran-Mantel-Haenszel|||||||0.0012
72329096|NCT01701362|144183256|SUPERIORITY_OR_OTHER_LEGACY||least square mean difference|-0.35|STANDARD_ERROR_OF_MEAN|0.14||0.0119||95.0|-0.62|-0.08|||Mixed Model Repeated Measures Analysis|Analyzed for treatment, center, trauma type, week \& treatment-by-week interaction and fixed continuous effect of baseline value on the ITT population.||Week 1||-0.08|-0.62|0.0119
72329097|NCT01701362|144183256|SUPERIORITY_OR_OTHER_LEGACY||least square mean difference|-0.34|STANDARD_ERROR_OF_MEAN|0.14||0.0135||95.0|-0.62|-0.07|||Mixed Model Repeated Measures Analysis|Analyzed for treatment, center, trauma type, week \& treatment-by-week interaction and fixed continuous effect of baseline value on the ITT population.||Week 2||-0.07|-0.62|0.0135
72329098|NCT01701362|144183256|SUPERIORITY_OR_OTHER_LEGACY||least square mean difference|-0.42|STANDARD_ERROR_OF_MEAN|0.14||0.0028||95.0|-0.69|-0.14|||Mixed Model Repeated Measures Analysis|Analyzed for treatment, center, trauma type, week \& treatment-by-week interaction and fixed continuous effect of baseline value on the ITT population.||Week 3||-0.14|-0.69|0.0028
72329099|NCT01701362|144183256|SUPERIORITY_OR_OTHER_LEGACY||least square mean difference|-0.44|STANDARD_ERROR_OF_MEAN|0.14||0.0016||95.0|-0.72|-0.17|||Mixed Model Repeated Measures Analysis|Analyzed for treatment, center, trauma type, week \& treatment-by-week interaction and fixed continuous effect of baseline value on the ITT population.||Week 4||-0.17|-0.72|0.0016
72329100|NCT01701362|144183256|SUPERIORITY_OR_OTHER_LEGACY||least square mean difference|-0.48|STANDARD_ERROR_OF_MEAN|0.14||0.0007||95.0|-0.75|-0.2|||Mixed Model Repeated Measures Analysis|Analyzed for treatment, center, trauma type, week \& treatment-by-week interaction and fixed continuous effect of baseline value on the ITT population.||Week 5||-0.20|-0.75|0.0007
72421081|NCT00261495|144353296|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.15||||0.526||95.0|-0.6|0.31||0.05 two-sided test|ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison||0.31|-0.60|0.526
72329101|NCT01701362|144183256|SUPERIORITY_OR_OTHER_LEGACY||least square mean difference|-0.48|STANDARD_ERROR_OF_MEAN|0.14||0.0006||95.0|-0.76|-0.21|||Mixed Model Repeated Measures Analysis|Analyzed for treatment, center, trauma type, week \& treatment-by-week interaction and fixed continuous effect of baseline value on the ITT population.||Week 6||-0.21|-0.76|0.0006
72329102|NCT01701362|144183256|SUPERIORITY_OR_OTHER_LEGACY||least square mean difference|-0.48|STANDARD_ERROR_OF_MEAN|0.14||0.0008||95.0|-0.75|-0.2|||Mixed Model Repeated Measures Analysis|Analyzed for treatment, center, trauma type, week \& treatment-by-week interaction and fixed continuous effect of baseline value on the ITT population.||Week 7||-0.20|-0.75|0.0008
72329103|NCT01701362|144183256|SUPERIORITY_OR_OTHER_LEGACY||least square mean difference|-0.52|STANDARD_ERROR_OF_MEAN|0.14||0.0003||95.0|-0.79|-0.24|||Mixed Model Repeated Measures Analysis|Analyzed for treatment, center, trauma type, week \& treatment-by-week interaction and fixed continuous effect of baseline value on the ITT population.||Week 8||-0.24|-0.79|0.0003
72329104|NCT01701362|144183256|SUPERIORITY_OR_OTHER_LEGACY||least square mean difference|-0.54|STANDARD_ERROR_OF_MEAN|0.14||0.0001||95.0|-0.82|-0.26|||Mixed Model Repeated Measures Analysis|Analyzed for treatment, center, trauma type, week \& treatment-by-week interaction and fixed continuous effect of baseline value on the ITT population.||Week 9||-0.26|-0.82|0.0001
72329105|NCT01701362|144183256|SUPERIORITY_OR_OTHER_LEGACY||least square mean difference|-0.49|STANDARD_ERROR_OF_MEAN|0.14||0.0005||95.0|-0.77|-0.22|||Mixed Model Repeated Measures Analysis|Analyzed for treatment, center, trauma type, week \& treatment-by-week interaction and fixed continuous effect of baseline value on the ITT population.||Week 10||-0.22|-0.77|0.0005
72329106|NCT01701362|144183256|SUPERIORITY_OR_OTHER_LEGACY||least square mean difference|-0.48|STANDARD_ERROR_OF_MEAN|0.14||0.0007||95.0|-0.76|-0.2|||Mixed Model Repeated Measures Analysis|Analyzed for treatment, center, trauma type, week \& treatment-by-week interaction and fixed continuous effect of baseline value on the ITT population.||Week 11||-0.20|-0.76|0.0007
72329107|NCT01701362|144183256|SUPERIORITY_OR_OTHER_LEGACY||least square mean difference|-0.54|STANDARD_ERROR_OF_MEAN|0.14||0.0001||95.0|-0.82|-0.27|||Mixed Model Repeated Measures Analysis|Analyzed for treatment, center, trauma type, week \& treatment-by-week interaction and fixed continuous effect of baseline value on the ITT population.||Week 12||-0.27|-0.82|0.0001
72329108|NCT01701362|144183256|SUPERIORITY_OR_OTHER_LEGACY||least square mean difference|-0.56|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001||95.0|-0.84|-0.28|||Mixed Model Repeated Measures Analysis|Analyzed for treatment, center, trauma type, week \& treatment-by-week interaction and fixed continuous effect of baseline value on the ITT population.||Week 13||-0.28|-0.84|<0.0001
72329109|NCT01701362|144183256|SUPERIORITY_OR_OTHER_LEGACY||least square mean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.14||0.0005||95.0|-0.78|-0.22|||Mixed Model Repeated Measures Analysis|Analyzed for treatment, center, trauma type, week \& treatment-by-week interaction and fixed continuous effect of baseline value on the ITT population.||Week 14||-0.22|-0.78|0.0005
72329110|NCT01701362|144183256|SUPERIORITY_OR_OTHER_LEGACY||least square mean difference|-0.43|STANDARD_ERROR_OF_MEAN|0.15||0.0031||95.0|-0.71|-0.14|||Mixed Model Repeated Measures Analysis|Analyzed for treatment, center, trauma type, week \& treatment-by-week interaction and fixed continuous effect of baseline value on the ITT population.||Week 15||-0.14|-0.71|0.0031
72329111|NCT01701362|144183256|SUPERIORITY_OR_OTHER_LEGACY||least square mean difference|-0.47|STANDARD_ERROR_OF_MEAN|0.12||0.0001||95.0|-0.71|-0.23|||Mixed Model Repeated Measures Analysis|Analyzed for treatment, center, trauma type, week \& treatment-by-week interaction and fixed continuous effect of baseline value on the ITT population.||Overall||-0.23|-0.71|0.0001
72329112|NCT01701362|144183257|SUPERIORITY_OR_OTHER_LEGACY||least squares mean difference|-0.46|STANDARD_ERROR_OF_MEAN|0.16||0.005||95.0|-0.77|-0.14|||ANCOVA|This secondary endpoint has been analyzed using ANCOVA with model terms of treatment, center, trauma type and baseline value on the ITT population.||||-0.14|-0.77|0.0050
72329113|NCT01701362|144183258|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.38|STANDARD_ERROR_OF_MEAN|0.16||0.0168||95.0|-0.7|-0.07|||ANCOVA|This secondary endpoint has been analyzed using ANCOVA with model terms of treatment, center, trauma type and baseline value on the ITT population.||||-0.07|-0.70|0.0168
72329114|NCT01701362|144183259|SUPERIORITY_OR_OTHER_LEGACY||least squares mean difference|-0.01|STANDARD_ERROR_OF_MEAN|0.037||0.6841||95.0|-0.09|0.06|||ANCOVA|This sub-score has been analyzed using ANCOVA with model terms of treatment, center, trauma type and baseline value on the ITT population.||This statistical analysis is for mobility||0.06|-0.09|0.6841
72329115|NCT01701362|144183259|SUPERIORITY_OR_OTHER_LEGACY||least squares mean difference|-0.01|STANDARD_ERROR_OF_MEAN|0.029||0.6564||95.0|-0.07|0.04|||ANCOVA|This sub-score has been analyzed using ANCOVA with model terms of treatment, center, trauma type and baseline value on the ITT population.||This statistical analysis is for self-care||0.04|-0.07|0.6564
72329116|NCT01701362|144183259|SUPERIORITY_OR_OTHER_LEGACY||least squares mean difference|0.01|STANDARD_ERROR_OF_MEAN|0.043||0.859||95.0|-0.08|0.09|||ANCOVA|This sub-score has been analyzed using ANCOVA with model terms of treatment, center, trauma type and baseline value on the ITT population.||This statistical analysis is for usual activities||0.09|-0.08|0.8590
72329117|NCT01701362|144183259|SUPERIORITY_OR_OTHER_LEGACY||least squares mean difference|-0.06|STANDARD_ERROR_OF_MEAN|0.043||0.1628||95.0|-0.14|0.02|||ANCOVA|This sub-score has been analyzed using ANCOVA with model terms of treatment, center, trauma type and baseline value on the ITT population.||This statistical analysis is for pain/discomfort||0.02|-0.14|0.1628
72421082|NCT00261495|144353297|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.06||||0.769||95.0|-0.49|0.36||0.05 two-sided test|ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison||0.36|-0.49|0.769
72329118|NCT01701362|144183259|SUPERIORITY_OR_OTHER_LEGACY||leaset squares mean difference|0.03|STANDARD_ERROR_OF_MEAN|0.037||0.4654||95.0|-0.05|0.1|||ANCOVA|This sub-score has been analyzed using ANCOVA with model terms of treatment, center, trauma type and baseline value on the ITT population.||This statistical analysis is for anxiety/depression||0.10|-0.05|0.4654
72421083|NCT00261495|144353298|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.04||||0.843||95.0|-0.4|0.49||0.05 two-sided test|ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison||0.49|-0.40|0.843
72421084|NCT00261495|144353299|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.01||||0.977||95.0|-0.45|0.44||0.05 two-sided test|ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison||0.44|-0.45|0.977
72421085|NCT00261495|144353300|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.01||||0.977||95.0|-0.47|0.49||0.05 two-sided test|ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison||0.49|-0.47|0.977
72421086|NCT00261495|144353301|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.03||||0.902||95.0|-0.51|0.45||0.05 two-sided test|ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison||0.45|-0.51|0.902
72421087|NCT00261495|144353303|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.36||||0.169||95.0|-5.74|1.02||0.05 two-sided test|ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison||1.02|-5.74|0.169
72421088|NCT00261495|144353304|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.89||||0.245||95.0|-5.09|1.31||0.05 two-sided test|ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison||1.31|-5.09|0.245
72421089|NCT00261495|144353305|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.64||||0.071||95.0|-5.51|0.23||0.05 two-sided test|ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison||0.23|-5.51|0.071
72421090|NCT00261495|144353306|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.03||||0.297||95.0|-5.85|1.8||0.05 two-sided test|ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison||1.80|-5.85|0.297
72421091|NCT00261495|144353307|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.41||||0.205||95.0|-1.32|6.14||0.05 two-sided test|ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison||6.14|-1.32|0.205
72421092|NCT00261495|144353308|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.35||||0.107||95.0|-7.43|0.73||0.05 two-sided test|ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison||0.73|-7.43|0.107
72421093|NCT00261495|144353309|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.6||||0.475||95.0|-2.8|6.0||0.05 two-sided test|ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison||6.00|-2.80|0.475
72421094|NCT00261495|144353310|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.16||||0.02||95.0|-7.67|-0.65||0.05 two-sided test|ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison||-0.65|-7.67|0.020
72421095|NCT00261495|144353311|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.02||||0.88||95.0|-0.3|0.26||0.05 two-sided test|ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison||0.26|-0.30|0.880
72421096|NCT00261495|144353312|SUPERIORITY_OR_OTHER|||||||0.32|||||||Cochran-Mantel-Haenszel|||Exploratory comparison||||0.320
72421097|NCT00261495|144353317|SUPERIORITY_OR_OTHER|||||||0.575|||||||Cochran-Mantel-Haenszel|||Exploratory comparison||||0.575
72421098|NCT00261495|144353318|SUPERIORITY_OR_OTHER|||||||0.807|||||||Cochran-Mantel-Haenszel|||Exploratory comparison||||0.807
72421099|NCT00261495|144353319|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.61||||0.118||95.0|-5.88|0.67|||ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison||0.67|-5.88|0.118
72421100|NCT00261495|144353320|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.08||||0.956||95.0|-3.08|2.91|||ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison||2.91|-3.08|0.956
72421101|NCT00261495|144353321|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.09||||0.299||95.0|-0.08|0.26|||ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison||0.26|-0.08|0.299
72421102|NCT00261495|144353322|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.13||||0.471||95.0|-4.2|1.95|||ANCOVA||Mean difference calculated: hydromorphone minus oxymorphone|Exploratory comparison||1.95|-4.20|0.471
72421103|NCT00261495|144353323|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.84||||0.025||95.0|0.48|7.19|||ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison||7.19|0.48|0.025
72421104|NCT00261495|144353324|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.4||||0.556||95.0|-5.61|10.42|||ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison||10.42|-5.61|0.556
72421105|NCT00261495|144353325|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.12||||0.551||95.0|-9.11|4.88|||ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison||4.88|-9.11|0.551
72421106|NCT00261495|144353326|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.98||||0.207||95.0|-7.63|1.66|||ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison||1.66|-7.63|0.207
72421107|NCT00261495|144353327|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.46||||0.123||95.0|-5.6|0.68|||ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison||0.68|-5.60|0.123
72329119|NCT01701362|144183259|SUPERIORITY_OR_OTHER_LEGACY||least squares mean difference|0.01|STANDARD_ERROR_OF_MEAN|0.017||0.5||95.0|-0.02|0.04|||ANCOVA|This sub-score has been analyzed using ANCOVA with model terms of treatment, center, trauma type and baseline value on the ITT population.||This statistical analysis is for Dolan 1997 Index score||0.04|-0.02|0.5000
72329120|NCT01701362|144183259|SUPERIORITY_OR_OTHER_LEGACY||leaset squares mean difference|-0.02|STANDARD_ERROR_OF_MEAN|0.026||0.5493||95.0|-0.07|0.04|||ANCOVA|This sub-score has been analyzed using ANCOVA with model terms of treatment, center, trauma type and baseline value on the ITT population.||This statistical analysis is for Dolan 2001 Index Score||0.04|-0.07|0.5493
72421108|NCT00261495|144353328|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.9||||0.602||95.0|-4.27|2.48|||ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison||2.48|-4.27|0.602
72421109|NCT00261495|144353329|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.65||||0.647||95.0|-2.14|3.44|||ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison||3.44|-2.14|0.647
72421110|NCT00261495|144353330|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.03||||0.627||95.0|-0.17|0.1|||ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison||0.10|-0.17|0.627
72421111|NCT00261495|144353331|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.3||||0.414||95.0|-4.45|1.84|||ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison||1.84|-4.45|0.414
72329121|NCT01701362|144183261|SUPERIORITY_OR_OTHER_LEGACY||least square mean difference|3.5|STANDARD_ERROR_OF_MEAN|1.8||0.0545||95.0|-0.07|7.0|||ANCOVA|This sub-score has been analyzed using ANCOVA with model terms of treatment, center, trauma type and baseline value on the ITT population.||Statistical analysis for Sleep Disturbance Score||7.00|-0.07|0.0545
72329122|NCT01701362|144183261|SUPERIORITY_OR_OTHER_LEGACY||least square mean difference|-2.0|STANDARD_ERROR_OF_MEAN|2.29||0.3913||95.0|-6.47|2.54|||ANCOVA|This sub-score has been analyzed using ANCOVA with model terms of treatment, center, trauma type and baseline value on the ITT population.||Statistical analysis for Sleep Adequancy Score||2.54|-6.47|0.3913
72421112|NCT00261495|144353332|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.05||||0.01||95.0|0.94|7.16|||ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison||7.16|0.94|0.010
72421113|NCT00261495|144353333|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.21||||0.955||95.0|-7.2|7.62|||ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison||7.62|-7.20|0.955
72421114|NCT00261495|144353334|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.31||||0.669||95.0|-4.72|7.34|||ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison||7.34|-4.72|0.669
72421115|NCT00261495|144353335|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.17||||0.595||95.0|-3.15|5.49|||ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison||5.49|-3.15|0.595
72329123|NCT01701362|144183261|SUPERIORITY_OR_OTHER_LEGACY||least square mean difference|-1.1|STANDARD_ERROR_OF_MEAN|2.04||0.6059||95.0|-5.06|2.96|||ANCOVA|This sub-score has been analyzed using ANCOVA with model terms of treatment, center, trauma type and baseline value on the ITT population.||Statistical analysis for Snoring Score||2.96|-5.06|0.6059
72329124|NCT01701362|144183261|SUPERIORITY_OR_OTHER_LEGACY||least square mean difference|0.6|STANDARD_ERROR_OF_MEAN|1.7||0.7317||95.0|-2.76|3.93|||ANCOVA|This sub-score has been analyzed using ANCOVA with model terms of treatment, center, trauma type and baseline value on the ITT population.||Statistical analysis for Awaken Short of Breath Score||3.93|-2.76|0.7317
72329125|NCT01701362|144183261|SUPERIORITY_OR_OTHER_LEGACY||least square mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.15||0.2663||95.0|-0.45|0.12|||ANCOVA|This sub-score has been analyzed using ANCOVA with model terms of treatment, center, trauma type and baseline value on the ITT population.||Statistical analysis for Quantity of Sleep Score (hours)||0.12|-0.45|0.2663
72329126|NCT01701362|144183261|SUPERIORITY_OR_OTHER_LEGACY||least square mean difference|-2.1|STANDARD_ERROR_OF_MEAN|1.5||0.1562||95.0|-5.08|0.82|||ANCOVA|This sub-score has been analyzed using ANCOVA with model terms of treatment, center, trauma type and baseline value on the ITT population.||Statistical analysis for Somnolence Score||0.82|-5.08|0.1562
72421116|NCT00261495|144353336|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.94||||0.543||95.0|-3.98|2.1|||ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison||2.10|-3.98|0.543
72329127|NCT01701362|144183261|SUPERIORITY_OR_OTHER_LEGACY||least square mean difference|1.7|STANDARD_ERROR_OF_MEAN|1.45||0.249||95.0|-1.18|4.53|||ANCOVA|This sub-score has been analyzed using ANCOVA with model terms of treatment, center, trauma type and baseline value on the ITT population.||Statistical analysis for Sleep Problem Index (9) Score||4.53|-1.18|0.2490
72329128|NCT01701362|144183261|SUPERIORITY_OR_OTHER_LEGACY||leaet squares mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.04||0.0609||95.0|-0.15|0.0|||ANCOVA|This sub-score has been analyzed using ANCOVA with model terms of treatment, center, trauma type and baseline value on the ITT population.||Statistical analysis for Optimal Sleep Score||0.00|-0.15|0.0609
72329129|NCT01701362|144183262|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7165||||||p-values based on CMH test stratified by pooled center and trauma type, patients with unknown status at baseline or endpoint will not be included in the calculation of p-values.|Cochran-Mantel-Haenszel|||||||0.7165
72329130|NCT01701362|144183263|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|3.2||||0.0028||95.0|1.5|6.86|||Gen linear model-logistic link function|Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.||Statistical analysis at Week 1||6.86|1.50|0.0028
72421117|NCT01059630|144353362|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.53|||<|0.0001|TWO_SIDED|95.0|0.4|0.7|||Log Rank|||||0.70|0.40|<0.0001
72329131|NCT01701362|144183263|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.66||||0.036||95.0|1.03|2.68|||Gen linear model-logistic link function|Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.||Statistical analysis at Week 2||2.68|1.03|0.0360
72329132|NCT01701362|144183263|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.62||||0.0235||95.0|1.07|2.45|||Gen linear model-logistic link function|Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.||Statistical analysis at Week 3||2.45|1.07|0.0235
72329133|NCT01701362|144183263|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.48||||0.0619||95.0|0.98|2.24|||Gen linear model-logistic link function|Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.||Statistical analysis at Week 4||2.24|0.98|0.0619
72329134|NCT01701362|144183263|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.46||||0.0677||95.0|0.97|2.2|||Gen linear model-logistic link function|Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.||Statistical analysis at Week 5||2.20|0.97|0.0677
72329135|NCT01701362|144183263|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.45||||0.0707||95.0|0.97|2.16|||Gen linear model-logistic link function|Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.||Statistical analysis at Week 6||2.16|0.97|0.0707
72329136|NCT01701362|144183263|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.37||||0.1313||95.0|0.91|2.06|||Gen linear model-logistic link function|Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.||Statistical analysis at Week 7||2.06|0.91|0.1313
72329137|NCT01701362|144183263|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.24||||0.3072||95.0|0.82|1.86|||Gen linear model-logistic link function|Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.||Statistical analysis at Week 8||1.86|0.82|0.3072
72329138|NCT01701362|144183263|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.19||||0.3947||95.0|0.79|1.8|||Gen linear model-logistic link function|Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.||Statistical analysis at Week 9||1.80|0.79|0.3947
72421118|NCT01059630|144353364|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.57|||<|0.0001|TWO_SIDED|95.0|0.45|0.73|||Log Rank|||||0.73|0.45|<0.0001
72421119|NCT01059630|144353365|SUPERIORITY_OR_OTHER_LEGACY||Difference in response rate|0.98||||0.9298|TWO_SIDED|95.0|0.58|1.65|||Cochran-Mantel-Haenszel|||||1.65|0.58|0.9298
72421120|NCT01059630|144353366|SUPERIORITY_OR_OTHER_LEGACY||Difference in response rate|-0.9||||0.7857|TWO_SIDED|95.0|-8.44|6.64|||Cochran-Mantel-Haenszel|||||6.64|-8.44|0.7857
72421121|NCT01059630|144353371|SUPERIORITY_OR_OTHER_LEGACY||Difference in response rate|2.24||||0.8347|TWO_SIDED|95.0|-7.2|11.69|||Cochran-Mantel-Haenszel|||||11.69|-7.20|0.8347
72421122|NCT01059630|144353372|SUPERIORITY_OR_OTHER_LEGACY||Difference in response rate|8.55||||0.0466|TWO_SIDED|95.0|-0.22|17.32|||Cochran-Mantel-Haenszel|||||17.32|-0.22|0.0466
72421123|NCT01059630|144353373|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.43|||||TWO_SIDED|95.0|0.31|0.61||||||||0.61|0.31|
72421124|NCT01059630|144353374|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.51|||||TWO_SIDED|95.0|0.39|0.67||||||||0.67|0.39|
72421125|NCT01059630|144353375|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.13|||||TWO_SIDED|95.0|0.04|0.45||||||||0.45|0.04|
72421126|NCT01059630|144353376|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.48|||||TWO_SIDED|95.0|0.29|0.81||||||||0.81|0.29|
72421127|NCT01059630|144353377|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.57||||0.0001|TWO_SIDED|95.0|0.44|0.74|||Log Rank|||||0.74|0.44|0.0001
72421128|NCT01059630|144353379|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.77||||0.081|TWO_SIDED|95.0|0.57|1.03|||Log Rank|||||1.03|0.57|0.0810
72421129|NCT03170375|144353394|SUPERIORITY|||||||0.28|||||||Regression, Linear|adjusted for baseline carotid-femoral pulse wave velocity||||||0.28
72421130|NCT03170375|144353395|SUPERIORITY|||||||0.6|||||||Regression, Linear|adjusted for baseline left ventricular mass index||||||0.60
72421131|NCT03170375|144353396|SUPERIORITY|||||||0.27|||||||Regression, Linear|adjusted for baseline global left ventricular longitudinal strain||||||0.27
72421132|NCT03170375|144353397|SUPERIORITY|||||||0.03|||||||Regression, Linear|adjusted for baseline carotid-femoral pulse wave velocity||||||0.03
72421133|NCT03170375|144353401|SUPERIORITY|||||||0.47|||||||generalized estimating equations|Model includes time (baseline, phase 2 month 1, phase 2 month 6), randomization assignment, and time x randomization assignment||||||0.47
72421134|NCT03170375|144353402|SUPERIORITY|||||||0.28|||||||generalized estimating equation|Model includes time (baseline, phase 2 month 1, phase 2 month 6), randomization assignment, and time x randomization assignment||||||0.28
72421135|NCT03170375|144353403|SUPERIORITY|||||||0.43|||||||generalized estimating equations|Model includes time (baseline, phase 2 month 1, phase 2 month 6), randomization assignment, and time x randomization assignment||||||0.43
72421136|NCT03170375|144353404|SUPERIORITY|||||||0.94|||||||t-test, 2 sided|||||||0.94
72421137|NCT03170375|144353405|SUPERIORITY|||||||0.9|||||||t-test, 2 sided|||||||0.90
72421138|NCT00530062|144353409|OTHER||Difference in adjusted mean|0.946||||0.5595|TWO_SIDED|95.0|-2.293|4.185||Threshold for significance at 0.05 level.|ANCOVA|||The analysis was performed using the mixed-effect analysis of variance with fixed effects of center, sequence, treatment group and period, and random effect of the participant within sequence.||4.185|-2.293|0.5595
72421139|NCT01376323|144353425|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.24|||||TWO_SIDED|95.0|-0.13|0.6||||||||0.60|-0.13|
72421140|NCT01376323|144353425|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.01|||||TWO_SIDED|95.0|-0.37|0.35||||||||0.35|-0.37|
72421141|NCT01376323|144353425|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.13|||||TWO_SIDED|95.0|-0.49|0.23||||||||0.23|-0.49|
72421142|NCT01376323|144353425|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.3|||||TWO_SIDED|95.0|-0.66|0.06||||||||0.06|-0.66|
72421143|NCT01376323|144353426|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.551|||||TWO_SIDED|95.0|-1.645|0.543|||||Comparison for glucose.|||0.543|-1.645|
72421144|NCT01376323|144353426|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.382|||||TWO_SIDED|95.0|-1.472|0.708|||||Comparison for glucose.|||0.708|-1.472|
72421145|NCT01376323|144353426|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.59|||||TWO_SIDED|95.0|-1.696|0.516|||||Comparison for glucose.|||0.516|-1.696|
72421146|NCT01376323|144353426|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.595|||||TWO_SIDED|95.0|-1.669|0.48|||||Comparison for glucose.|||0.480|-1.669|
72421147|NCT01376323|144353426|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.036|||||TWO_SIDED|95.0|-0.042|0.113|||||Comparison for NEFA.|||0.113|-0.042|
72421148|NCT01376323|144353426|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.004|||||TWO_SIDED|95.0|-0.073|0.081|||||Comparison for NEFA.|||0.081|-0.073|
72421149|NCT01376323|144353426|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.021|||||TWO_SIDED|95.0|-0.058|0.099|||||Comparison for NEFA.|||0.099|-0.058|
72421150|NCT01376323|144353426|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.083|||||TWO_SIDED|95.0|-0.16|-0.007|||||Comparison for NEFA.|||-0.007|-0.160|
72421151|NCT01376323|144353428|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.07|||||TWO_SIDED|95.0|-0.79|0.94||||||||0.94|-0.79|
72421152|NCT01376323|144353428|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.04|||||TWO_SIDED|95.0|-0.9|0.82||||||||0.82|-0.90|
72421153|NCT01376323|144353428|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.02|||||TWO_SIDED|95.0|-0.9|0.85||||||||0.85|-0.90|
72421154|NCT01376323|144353428|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.42|||||TWO_SIDED|95.0|-1.27|0.42||||||||0.42|-1.27|
72421155|NCT01376323|144353429|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.27|||||TWO_SIDED|95.0|-48.62|53.16||||||||53.16|-48.62|
72421156|NCT01376323|144353429|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-7.67|||||TWO_SIDED|95.0|-58.04|42.7||||||||42.70|-58.04|
72421157|NCT01376323|144353429|SUPERIORITY_OR_OTHER||Median Difference (Net)|24.08|||||TWO_SIDED|95.0|-27.75|75.92||||||||75.92|-27.75|
72421158|NCT01376323|144353429|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.09|||||TWO_SIDED|95.0|-52.72|48.53||||||||48.53|-52.72|
72421159|NCT01376323|144353431|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.58|||||TWO_SIDED|95.0|-19.36|16.2||||||||16.20|-19.36|
72421160|NCT01376323|144353431|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-15.1|||||TWO_SIDED|95.0|-33.0|2.81||||||||2.81|-33.00|
72421161|NCT01376323|144353431|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-14.09|||||TWO_SIDED|95.0|-32.41|4.23||||||||4.23|-32.41|
72421162|NCT01376323|144353431|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-19.12|||||TWO_SIDED|95.0|-36.55|-1.68||||||||-1.68|-36.55|
72421163|NCT04681729|144353433|SUPERIORITY||Odds Ratio (OR)|1.03||||0.9492|TWO_SIDED|95.0|0.41|2.56||Cochran-Mantel-Haenszel test was performed on the association between the ice cube provocation test result and intervention group, stratified by region and background H1-antihistamine regular/daily use (Yes or No). Threshold of significance at 0.01.|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control the family-wise type-I error. Testing was then performed sequentially in order the endpoints were reported and continued when primary endpoint was statistically significant at two-sided 0.01.||2.56|0.41|0.9492
72421164|NCT04766086|144353486|OTHER||Risk difference|0.0||||||95.0|-3.8|3.7||||||||3.7|-3.8|
72421165|NCT04766086|144353487|OTHER||GMR|0.546|||||TWO_SIDED|95.0|0.405|0.736||||||GMR for Anti-PT Antibody: GMR for GBS6 + Tdap/Placebo + Tdap was calculated by back transforming the mean difference between the 2 measures on the logarithmic scale.||0.736|0.405|
72421166|NCT04766086|144353487|OTHER||GMR|0.567|||||TWO_SIDED|95.0|0.455|0.707||||||GMR for Anti-FHA Antibody: GMR for GBS6 + Tdap/Placebo + Tdap was calculated by back transforming the mean difference between the 2 measures on the logarithmic scale.||0.707|0.455|
72421167|NCT04766086|144353487|OTHER||GMR|0.588|||||TWO_SIDED|95.0|0.451|0.766||||||GMR for Anti-PRN Antibody: GMR for GBS6 + Tdap/Placebo + Tdap was calculated by back transforming the mean difference between the 2 measures on the logarithmic scale.||0.766|0.451|
72421168|NCT04766086|144353488|OTHER||GMR|0.89|||||TWO_SIDED|95.0|0.38|2.089||||||GMR for serotype Ia: GMR for GBS6 + GBS6/Placebo + Tdap was calculated by back transforming the mean difference between the 2 measures on the logarithmic scale.||2.089|0.380|
72421169|NCT04766086|144353488|OTHER||GMR|1.149|||||TWO_SIDED|95.0|0.455|2.901||||||GMR for serotype Ib: GMR for GBS6 + GBS6/Placebo + Tdap was calculated by back transforming the mean difference between the 2 measures on the logarithmic scale.||2.901|0.455|
72421170|NCT04766086|144353488|OTHER||GMR|1.032||||||95.0|0.551|1.931||||||GMR for serotype II: GMR for GBS6 + GBS6/Placebo + Tdap was calculated by back transforming the mean difference between the 2 measures on the logarithmic scale.||1.931|0.551|
72421171|NCT04766086|144353488|OTHER||GMR|0.635|||||TWO_SIDED|95.0|0.303|1.329||||||GMR for serotype III: GMR for GBS6 + GBS6/Placebo + Tdap was calculated by back transforming the mean difference between the 2 measures on the logarithmic scale.||1.329|0.303|
72421172|NCT04766086|144353488|OTHER||GMR|1.474|||||TWO_SIDED|95.0|0.842|2.58||||||GMR for serotype IV: GMR for GBS6 + GBS6/Placebo + Tdap was calculated by back transforming the mean difference between the 2 measures on the logarithmic scale.||2.580|0.842|
72421173|NCT04766086|144353488|OTHER||GMR|0.559|||||TWO_SIDED|95.0|0.232|1.349||||||GMR for serotype V: GMR for GBS6 + GBS6/Placebo + Tdap was calculated by back transforming the mean difference between the 2 measures on the logarithmic scale.||1.349|0.232|
72421174|NCT03138733|144353561|NON_INFERIORITY|The non-inferiority hypothesis test was a one-sided hypothesis test performed at the 2.5% level of significance. If the lower limit of the two sided 95% CI for the difference in response rates in the mITT population was greater than -15%, the non-inferiority of ceftobiprole to daptomycin therapy was to be concluded.|Adjusted proportion difference|2.0|||||TWO_SIDED|95.0|-7.1|11.1||||||The observed difference in percentage of responders at PTE (ceftobiprole group minus the daptomycin group) were determined and a two-sided 95% confidence interval (CI) for the observed difference was computed, with adjustment for actual stratum (dialysis status and prior antibacterial treatment use). Cochran-Mantel-Haenszel (CMH) weights were used for the stratum weight in the calculation of the CI||11.1|-7.1|
72421175|NCT03138733|144353562|OTHER||Adjusted proportion difference|0.6|||||TWO_SIDED|95.0|-8.3|9.5|||||The two-sided 95% CI was computed using Cochran-Mantel-Haenszel (CMH) weights method adjusted for actual stratum (dialysis status and prior antibacterial treatment use)|||9.5|-8.3|
72421176|NCT03138733|144353563|OTHER||Adjusted proportion difference|5.1|||||TWO_SIDED|95.0|-2.9|13.0|||||The two-sided 95% CI was computed using Cochran-Mantel-Haenszel (CMH) weights method adjusted for actual stratum (dialysis status and prior antibacterial treatment use)|||13|-2.9|
72421177|NCT03138733|144353564|OTHER||Adjusted proportion difference|-0.5|||||TWO_SIDED|95.0|-6.2|5.2|||||The two-sided 95% CI was computed using Cochran-Mantel-Haenszel (CMH) weights method adjusted for actual stratum (dialysis status and prior antibacterial treatment use)|||5.2|-6.2|
72421178|NCT03138733|144353565|OTHER||Adjusted proportion difference|0.1|||||TWO_SIDED|95.0|-4.6|4.8|||||The two-sided 95% CI was computed using Cochran-Mantel-Haenszel (CMH) weights method adjusted for actual stratum (dialysis status and prior antibacterial treatment use)|||4.8|-4.6|
72421179|NCT04506775|144353572|NON_INFERIORITY|As per the FDA standard ANSI/AAMI SP10:2008 or the newly adopted ISO 81060-3:2022 standard, the mean error should be \<5mmHg or \<6mmHg and the standard deviation should be \<8mmHg or \<10mmHg respectively.|Mean Error|0.9|||||TWO_SIDED|||||As per the FDA standard ANSI/AAMI SP10:2008 or the newly adopted ISO 81060-3:2022 standard, the mean error should be \<5mmHg or \<6mmHg and the standard deviation should be \<8mmHg or \<10mmHg respectively.||||||||
72421180|NCT04506775|144353573|NON_INFERIORITY|As per the FDA standard ANSI/AAMI SP10:2008 or the newly adopted ISO 81060-3:2022 standard, the mean error should be \< 5mmHg or \<6mmHg and the standard deviation should be \<8mmHg or \<10mmHg respectively|Mean Error|0.19|||||TWO_SIDED|||||As per the FDA standard ANSI/AAMI SP10:2008 or the newly adopted ISO 81060-3:2022 standard, the mean error should be \< 5mmHg or \<6mmHg and the standard deviation should be \<8mmHg or \<10mmHg respectively|||As per the FDA standard ANSI/AAMI SP10:2008 or the newly adopted ISO 81060-3:2022 standard, the mean error should be \< 5mmHg or \<6mmHg and the standard deviation should be \<8mmHg or \<10mmHg respectively||As per the FDA standard ANSI/AAMI SP10:2008 or the newly adopted ISO 81060-3:2022 standard, the mean error should be \< 5mmHg or \<6mmHg and the standard deviation should be \<8mmHg or \<10mmHg respectively|||
72421181|NCT02612064|144353583|SUPERIORITY_OR_OTHER||Least Square (LS) mean difference|-0.18||||0.1575|TWO_SIDED|95.0|-0.442|0.072|||ANCOVA|Change from baseline in Schiff Sensitivity Score as response, treatment as a factor and baseline Schiff sensitivity as a covariate.|Difference is first named dentifrice minus second named dentifrice such that a negative difference favours first named dentifrice.|All statistical analyses were conducted under the null hypothesis (H0) of no difference between treatments versus the alternate hypothesis (H1) of a difference between treatments.||0.072|-0.442|0.1575
72421182|NCT00985010|144353596|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|15.0|STANDARD_DEVIATION|5.0||0.05|||||||Chi-squared||The difference is between the percentage of deaths (males versus females) after six months in the patients with hepatic encephalophathy.|Clinical evolution was reported as percentage (still alive or death after six months of follow up).||||0.05
72421183|NCT00985010|144353597|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|23.05|STANDARD_DEVIATION|10.72||0.05||95.0|||||Wilcoxon (Mann-Whitney)||The difference is between manganese levels of women minus manganese levels of men.|Laboratory results were expressed in means and standard deviations. Between group comparisons (female versus male values) were made with the Mann-Whitney U test using the Statistical Package for Social Sciences (SPSS) program version 10 (SPSS Inc., North Carolina, USA).||||0.05
72421184|NCT01678131|144353598|SUPERIORITY_OR_OTHER_LEGACY||Posterior Percentage Probability|100.0||||||||||||||The posterior percentage probability of the true success rate of the FNA procedure for the 3 combined treatment groups (n=29) was determined by a Bayesian calculation, using a Jeffrey's prior distribution (i.e. Beta \[0.5,0.5\]) on the true success rate. Neither P-values, nor confidence intervals are estimated in this analysis. The primary hypothesis was met if the posterior percentage probability was \> 80% that the true success rate is at least 60%.||||
72421185|NCT00685945|144353616|SUPERIORITY_OR_OTHER|||||||0.04||95.0|||||ANOVA|||The effect of bradykinin on net t-PA release was determined using general linear model-repeated measures ANOVA in which the between-subject variable was gender, and the within-subjects variables were drug (control, +L-NMMA, +L-NMMA plus isosorbide, or +L-NMMA plus sildenafil) and dose of bradykinin.||||0.04
72421186|NCT00685945|144353617|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA|Repeated measures ANOVA||||||<0.001
72421187|NCT03183388|144353619|OTHER|Mixed model with time (baseline and endpoint) as within-subjects factor; compare Least Square (LS) estimate of endpoint minus baseline to zero. The best-fitting model was chosen based on information criteria.|Endpoint minus Baseline|-3.04|STANDARD_ERROR_OF_MEAN|0.5||0.0001|TWO_SIDED|95.0|-4.14|-1.93|||t-test, 2 sided|||||-1.93|-4.14|0.0001
72421188|NCT03183388|144353620|OTHER|Mixed model with time (baseline and midpoint) as within-subjects factor; compare LS estimate of midpoint minus baseline to zero.|Midpoint minus Baseline|-1.37|STANDARD_ERROR_OF_MEAN|2.51||0.6|TWO_SIDED|95.0|-6.97|4.23|||t-test, 2 sided|||||4.23|-6.97|0.60
72421189|NCT03183388|144353621|OTHER|Mixed model with time (baseline and endpoint) as within-subjects factor; compare LS estimate of endpoint minus baseline to zero.|Endpoint minus Baseline|0.11|STANDARD_ERROR_OF_MEAN|0.016||0.0001|TWO_SIDED|95.0|0.074|0.146|||t-test, 2 sided|||||0.146|0.074|0.0001
72421190|NCT03183388|144353622|OTHER|Mixed model with time (baseline and midpoint) as within-subjects factor; compare LS estimate of midpoint minus baseline to zero.|Midpoint minus Baseline|0.031|STANDARD_ERROR_OF_MEAN|0.055||0.58|TWO_SIDED|95.0|-0.095|0.157|||t-test, 2 sided|||||0.157|-0.095|0.58
72421191|NCT00071721|144353631|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.958||||0.88||95.0|||||Cox Proportional Hazards|||||||0.88
72421192|NCT03091673|144353649|OTHER||||||<|0.001||||||P-value was computed using a t-test to determine if change in plasma glucose from baseline to 30 minutes was zero.|t-test, 2 sided|||||||<0.001
72421193|NCT02802501|144353656|SUPERIORITY||Hazard Ratio (HR)|0.444|||<|0.001|TWO_SIDED|95.0|0.285|0.693|||Cox Proportional Hazard||If hazard ratio was found to be \<1 then there are lower chances of relapse with Tafenoquine+DHA-PQP compared to DHA-PQP only.|||0.693|0.285|<0.001
72421194|NCT02802501|144353657|SUPERIORITY||Hazard Ratio (HR)|1.722|||||TWO_SIDED|95.0|1.031|2.875|||||If hazard ratio was found to be \>1 then there are higher chances of relapse with Tafenoquine+DHA-PQP compared to Primaquine+DHA-PQP.|||2.875|1.031|
72421195|NCT02802501|144353658|SUPERIORITY||Hazard Ratio (HR)|0.258|||||TWO_SIDED|95.0|0.155|0.431|||||If hazard ratio was found to be \<1 then there are lower chances of relapse with Primaquine+DHA-PQP compared to DHA-PQP only.|||0.431|0.155|
72421196|NCT02802501|144353659|SUPERIORITY||Hazard Ratio (HR)|0.433|||||TWO_SIDED|95.0|0.273|0.686|||||If hazard ratio was found to be \<1 then there are lower chances of relapse with Tafenoquine+DHA-PQP compared to DHA-PQP only.|||0.686|0.273|
72421197|NCT01544998|144353689|SUPERIORITY_OR_OTHER|||||||0.26|TWO_SIDED||||||t-test, 2 sided|||This was a within PSD reporting group comparison; between PSD and PDD groups were not compared.||||0.26
72421198|NCT01544998|144353690|SUPERIORITY_OR_OTHER|||||||0.9|TWO_SIDED||||||t-test, 2 sided|||This was a within PDD reporting group comparison; between PSD and PDD groups were not compared.||||0.90
72421199|NCT01544998|144353691|SUPERIORITY|||||||0.003|||||||t-test, 2 sided|||This was a within PSD reporting group comparison; between PSD and PDD groups were not compared.||||0.003
72329139|NCT01701362|144183263|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.36||||0.1462||95.0|0.9|2.05|||Gen linear model-logistic link function|Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.||Statistical analysis at Week 10||2.05|0.90|0.1462
72329140|NCT01701362|144183263|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.09||||0.6854||95.0|0.72|1.64|||Gen linear model-logistic link function|Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.||Statistical analysis at Week 11||1.64|0.72|0.6854
72329141|NCT01701362|144183263|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.15||||0.5025||95.0|0.76|1.74|||Gen linear model-logistic link function|Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.||Statistical analysis at Week 12||1.74|0.76|0.5025
72329142|NCT01701362|144183263|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.16||||0.4908||95.0|0.76|1.76|||Gen linear model-logistic link function|Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.||Statistical analysis at Week 13||1.76|0.76|0.4908
72329143|NCT01701362|144183263|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.19||||0.4245||95.0|0.78|1.8|||Gen linear model-logistic link function|Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.||Statistical analysis at Week 14||1.80|0.78|0.4245
72329144|NCT01701362|144183263|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.96||||0.8464||95.0|0.61|1.49|||Gen linear model-logistic link function|Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.||Statistical analysis at Week 15||1.49|0.61|0.8464
72329145|NCT01701362|144183264|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.11||||0.1633||95.0|0.74|6.0|||Gen linear model-logistic link function|Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.||Statistical analysis at Week 1||6.00|0.74|0.1633
72329146|NCT01701362|144183264|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.92||||0.0652||95.0|0.96|3.85|||Gen linear model-logistic link function|Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.||Statistical analysis at Week 2||3.85|0.96|0.0652
72329147|NCT01701362|144183264|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.2||||0.0039||95.0|1.29|3.77|||Gen linear model-logistic link function|Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.||Statistical analysis at Week 3||3.77|1.29|0.0039
72329148|NCT01701362|144183264|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.71||||0.0382||95.0|1.03|2.83|||Gen linear model-logistic link function|Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.||Statistical analysis at Week 4||2.83|1.03|0.0382
72421200|NCT01544998|144353692|SUPERIORITY|||||||0.14|||||||t-test, 2 sided|||This was a within PDD reporting group comparison; between PSD and PDD groups were not compared.||||0.14
72329149|NCT01701362|144183264|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.86||||0.0137||95.0|1.14|3.05|||Gen linear model-logistic link function|Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.||Statistical analysis at Week 5||3.05|1.14|0.0137
72329150|NCT01701362|144183264|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.55||||0.0693||95.0|0.97|2.49|||Gen linear model-logistic link function|Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.||Statistical analysis at Week 6||2.49|0.97|0.0693
72329151|NCT01701362|144183264|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.68||||0.0349||95.0|1.04|2.73|||Gen linear model-logistic link function|Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.||Statistical analysis at Week 7||2.73|1.04|0.0349
72329152|NCT01701362|144183264|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.44||||0.1227||95.0|0.91|2.29|||Gen linear model-logistic link function|Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.||Statistical analysis at Week 8||2.29|0.91|0.1227
72329153|NCT01701362|144183264|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.65||||0.0364||95.0|1.03|2.63|||Gen linear model-logistic link function|Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.||Statistical analysis at Week 9||2.63|1.03|0.0364
72329154|NCT01701362|144183264|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.55||||0.0667||95.0|0.97|2.49|||Gen linear model-logistic link function|Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.||Statistical analysis at Week 10||2.49|0.97|0.0667
72421201|NCT01544998|144353693|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||This was a within PSD reporting group comparison; between PSD and PDD groups were not compared.||||<0.001
72421202|NCT01544998|144353694|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||This was a within PDD reporting group comparison; between PSD and PDD groups were not compared.||||<0.001
72421203|NCT00514683|144353698|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.016|STANDARD_ERROR_OF_MEAN|0.052||0.853|TWO_SIDED|95.0|-0.086|0.118||The p-value presented is computed in the course of the closing testing procedure.|Mixed Models Analysis|MMRM with fixed terms for treatment\*time, gender\*height, gender\*age and random terms for patient effect, patient\*time.|Mean difference to placebo is calculated. Negative change indicates worsening.|||0.118|-0.086|0.8530
72421204|NCT00514683|144353698|SUPERIORITY_OR_OTHER|||||||0.7558||||||The p-value from the hierarchical testing procedure was calculated as a sensitivity analysis|Mixed Models Analysis|MMRM with fixed terms for treatment\*time, gender\*height, gender\*age and random terms for patient effect, patient\*time.||||||0.7558
72421205|NCT00514683|144353698|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.051||0.792|TWO_SIDED|95.0|-0.119|0.08||The p-value presented is computed in the course of the closing testing procedure.|Mixed Models Analysis|MMRM with fixed terms for treatment\*time, gender\*height, gender\*age and random terms for patient effect, patient\*time.|Mean difference to placebo is calculated. Negative change indicates worsening.|||0.080|-0.119|0.7920
72421206|NCT00514683|144353698|SUPERIORITY_OR_OTHER|||||||0.6991||||||The p-value from the hierarchical testing procedure was calculated as a sensitivity analysis|Mixed Models Analysis|MMRM with fixed terms for treatment\*time, gender\*height, gender\*age and random terms for patient effect, patient\*time.||||||0.6991
72421207|NCT00514683|144353698|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.028|STANDARD_ERROR_OF_MEAN|0.051||0.853|TWO_SIDED|95.0|-0.071|0.128||The p-value presented is computed in the course of the closing testing procedure.|Mixed Models Analysis|MMRM with fixed terms for treatment\*time, gender\*height, gender\*age and random terms for patient effect, patient\*time.|Mean difference to placebo is calculated. Negative change indicates worsening.|||0.128|-0.071|0.8530
72421208|NCT00514683|144353698|SUPERIORITY_OR_OTHER|||||||0.5736||||||Additionally the p-value from the hierarchical testing procedure was calculated as a sensitivity analysis|Mixed Models Analysis|MMRM with fixed terms for treatment\*time, gender\*height, gender\*age and random terms for patient effect, patient\*time.||||||0.5736
72421209|NCT00514683|144353698|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.131|STANDARD_ERROR_OF_MEAN|0.053||0.0639|TWO_SIDED|95.0|0.027|0.235||The p-value presented is computed in the course of the closing testing procedure.|Mixed Models Analysis|MMRM with fixed terms for treatment\*time, gender\*height, gender\*age and random terms for patient effect, patient\*time.|Mean difference to placebo is calculated. Negative change indicates worsening.|||0.235|0.027|0.0639
72421210|NCT00514683|144353698|SUPERIORITY_OR_OTHER|||||||0.0136||||||Additionally the p-value from the hierarchical testing procedure was calculated as a sensitivity analysis|Mixed Models Analysis|MMRM with fixed terms for treatment\*time, gender\*height, gender\*age and random terms for patient effect, patient\*time.||||||0.0136
72421211|NCT00514683|144353699|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.43|STANDARD_ERROR_OF_MEAN|1.312||0.2774|TWO_SIDED|95.0|-1.15|4.01|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||4.01|-1.15|0.2774
72421212|NCT00514683|144353699|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.1|STANDARD_ERROR_OF_MEAN|1.312||0.4014|TWO_SIDED|95.0|-1.48|3.68|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||3.68|-1.48|0.4014
72421213|NCT00514683|144353699|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.86|STANDARD_ERROR_OF_MEAN|1.324||0.0314|TWO_SIDED|95.0|0.26|5.46|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||5.46|0.26|0.0314
72421214|NCT00514683|144353699|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.97|STANDARD_ERROR_OF_MEAN|1.319||0.0002|TWO_SIDED|95.0|2.37|7.56|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||7.56|2.37|0.0002
72421215|NCT00514683|144353700|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.04|STANDARD_ERROR_OF_MEAN|0.046||0.3644|TWO_SIDED|95.0|-0.05|0.13|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||0.13|-0.05|0.3644
72329155|NCT01701362|144183264|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.77||||0.0176||95.0|1.1|2.84|||Gen linear model-logistic link function|Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.||Statistical analysis at Week 11||2.84|1.10|0.0176
72329156|NCT01701362|144183264|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.03||||0.003||95.0|1.27|3.23|||Gen linear model-logistic link function|Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.||Statistical analysis at Week 12||3.23|1.27|0.0030
72329157|NCT01701362|144183264|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.71||||0.0256||95.0|1.07|2.74|||Gen linear model-logistic link function|Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.||Statistical analysis at Week 13||2.74|1.07|0.0256
72329158|NCT01701362|144183264|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.66||||0.0314||95.0|1.05|2.64|||Gen linear model-logistic link function|Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.||Statistical analysis at Week 14||2.64|1.05|0.0314
72329159|NCT01701362|144183264|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.38||||0.1889||95.0|0.85|2.21|||Gen linear model-logistic link function|Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.||Statistical analysis at Week 15||2.21|0.85|0.1889
72329160|NCT00485758|144183273|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.9|STANDARD_ERROR_OF_MEAN|1.8|<|0.001||95.0|-21.4|-14.4|||Wilcoxon (Mann-Whitney)|Study times: 4, 8 and 12 weeks. Terms: treatment-by-time, gender-by-time and baseline low-density lipoprotein cholesterol -by-time interaction.||||-14.4|-21.4|<0.001
72329161|NCT00485758|144183274|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|23.2|STANDARD_ERROR_OF_MEAN|1.3|<|0.001||95.0|20.7|25.7|||Repeated Measures Analysis|Study times: 4, 8 and 12 weeks. Terms: treatment-by-time, gender-by-time and baseline high-density lipoprotein cholesterol -by-time interaction.||||25.7|20.7|<0.001
72329162|NCT00485758|144183275|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-23.1|||<|0.001||95.0|-27.2|-18.9|||ANCOVA|Nonparametric Analysis of Covariance model based on Tukey's normalized ranks with term for treatment, gender and Tukey's normal score of baseline.|The median difference between treatments is based on the Hodges-Lehmann estimates of shift with a corresponding distribution-free Confidence Interval based on Wilcoxon's rank|||-18.9|-27.2|<0.001
72329163|NCT00654745|144183276|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-19.9|||<|0.0001|TWO_SIDED|95.0|-21.5|-18.4|||t-test, 2 sided|||||-18.4|-21.5|<0.0001
72329164|NCT00654745|144183277|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-11.2|||<|0.0001|TWO_SIDED|95.0|-12.2|-10.3||24-hour mean DBP change from baseline to week 12.|t-test, 2 sided|standard 1-sample confidence interval construction using t-distribution with 164 degrees of freedom||Primary null hypothesis is change from baseline to week12 in ABPM is 0. Change from baseline to week12 is primary efficacy variable and used all ABPM subjects. Null hypothesis used 1-sample t-test on change. Sample size of 200 expected to provide 99% power at significance level of 0.05%.||-10.3|-12.2|<0.0001
72329165|NCT00654745|144183277|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-11.7|||<|0.0001|TWO_SIDED|95.0|-12.9|-10.5||daytime mean DBP change from baseline to week 12.|t-test, 2 sided|standard 1-sample confidence interval construction using t-distribution with 164 degrees of freedom||Primary null hypothesis is change from baseline to week12 in ABPM is 0. Change from baseline to week12 is primary efficacy variable and used all ABPM subjects. Null hypothesis used 1-sample t-test on change. Sample size of 200 expected to provide 99% power at significance level of 0.05%.||-10.5|-12.9|<0.0001
72421216|NCT00514683|144353700|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.03|STANDARD_ERROR_OF_MEAN|0.046||0.4525|TWO_SIDED|95.0|-0.06|0.13|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||0.13|-0.06|0.4525
72421217|NCT00514683|144353700|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.09|STANDARD_ERROR_OF_MEAN|0.046||0.0471|TWO_SIDED|95.0|0.0|0.18|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||0.18|0.00|0.0471
72421218|NCT00514683|144353700|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.17|STANDARD_ERROR_OF_MEAN|0.046||0.0004|TWO_SIDED|95.0|0.08|0.26|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||0.26|0.08|0.0004
72421219|NCT00514683|144353701|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.91|STANDARD_ERROR_OF_MEAN|1.702||0.592|TWO_SIDED|95.0|-2.43|4.26|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||4.26|-2.43|0.5920
72421220|NCT00514683|144353701|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.86|STANDARD_ERROR_OF_MEAN|1.702||0.6155|TWO_SIDED|95.0|-2.49|4.2|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||4.20|-2.49|0.6155
72421221|NCT00514683|144353701|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.81|STANDARD_ERROR_OF_MEAN|1.716||0.0271|TWO_SIDED|95.0|0.43|7.18|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||7.18|0.43|0.0271
72329166|NCT00654745|144183277|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-10.4|||<|0.0001|TWO_SIDED|95.0|-11.7|-9.0||nighttime mean DBP change from baseline to week 12.|t-test, 2 sided|standard 1-sample confidence interval construction using t-distribution with 164 degrees of freedom||Primary null hypothesis is change from baseline to week12 in ABPM is 0. Change from baseline to week12 is primary efficacy variable and used all ABPM subjects. Null hypothesis used 1-sample t-test on change. Sample size of 200 expected to provide 99% power at significance level of 0.05%.||-9.0|-11.7|<0.0001
72329167|NCT00654745|144183277|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-10.9|||<|0.0001|TWO_SIDED|95.0|-12.2|-9.7||last 6 hours mean DBP change from baseline to week 12.|t-test, 2 sided|standard 1-sample confidence interval construction using t-distribution with 164 degrees of freedom||Primary null hypothesis is change from baseline to week12 in ABPM is 0. Change from baseline to week12 is primary efficacy variable and used all ABPM subjects. Null hypothesis used 1-sample t-test on change. Sample size of 200 expected to provide 99% power at significance level of 0.05%.||-9.7|-12.2|<0.0001
72329168|NCT00654745|144183277|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-11.1|||<|0.0001|TWO_SIDED|95.0|-12.4|-9.8||last 4 hours mean DBP change from baseline to week 12.|t-test, 2 sided|standard 1-sample confidence interval construction using t-distribution with 164 degrees of freedom||Primary null hypothesis is change from baseline to week12 in ABPM is 0. Change from baseline to week12 is primary efficacy variable and used all ABPM subjects. Null hypothesis used 1-sample t-test on change. Sample size of 200 expected to provide 99% power at significance level of 0.05%.||-9.8|-12.4|<0.0001
72329169|NCT00654745|144183277|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-11.5|||<|0.0001|TWO_SIDED|95.0|-13.1|-10.0||last 2 hours mean DBP change from baseline to week 12.|t-test, 2 sided|standard 1-sample confidence interval construction using t-distribution with 164 degrees of freedom||Primary null hypothesis is change from baseline to week12 in ABPM is 0. Change from baseline to week12 is primary efficacy variable and used all ABPM subjects. Null hypothesis used 1-sample t-test on change. Sample size of 200 expected to provide 99% power at significance level of 0.05%.||-10.0|-13.1|<0.0001
72329170|NCT00654745|144183278|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-20.8|||<|0.0001|TWO_SIDED|95.0|-22.6|-18.9||daytime mean SBP change from baseline to week 12.|t-test, 2 sided|standard 1-sample confidence interval construction using t-distribution with 164 degrees of freedom||Primary null hypothesis is change from baseline to week12 in ABPM is 0. Change from baseline to week12 is primary efficacy variable and used all ABPM subjects. Null hypothesis used 1-sample t-test on change. Sample size of 200 expected to provide 99% power at significance level of 0.05%.||-18.9|-22.6|<0.0001
72329171|NCT00654745|144183278|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-18.5|||<|0.0001|TWO_SIDED|95.0|-20.4|-16.6||nighttime mean SBP change from baseline to week 12.|t-test, 2 sided|standard 1-sample confidence interval construction using t-distribution with 164 degrees of freedom||Primary null hypothesis is change from baseline to week12 in ABPM is 0. Change from baseline to week12 is primary efficacy variable and used all ABPM subjects. Null hypothesis used 1-sample t-test on change. Sample size of 200 expected to provide 99% power at significance level of 0.05%.||-16.6|-20.4|<0.0001
72329172|NCT00654745|144183278|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-18.9|||<|0.0001|TWO_SIDED|95.0|-20.7|-17.0||last 6 hours mean SBP change from baseline to week 12.|t-test, 2 sided|standard 1-sample confidence interval construction using t-distribution with 164 degrees of freedom||Primary null hypothesis is change from baseline to week12 in ABPM is 0. Change from baseline to week12 is primary efficacy variable and used all ABPM subjects. Null hypothesis used 1-sample t-test on change. Sample size of 200 expected to provide 99% power at significance level of 0.05%.||-17.0|-20.7|<0.0001
72421222|NCT00514683|144353701|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.47|STANDARD_ERROR_OF_MEAN|1.71||0.0015|TWO_SIDED|95.0|2.11|8.83|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||8.83|2.11|0.0015
72421223|NCT00514683|144353702|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.99|STANDARD_ERROR_OF_MEAN|1.692||0.5601|TWO_SIDED|95.0|-2.34|4.31||ANCOVA with fixed terms for treatment, baseline, region.|ANCOVA||Mean difference to placebo is calculated. Negative change indicates worsening.|||4.31|-2.34|0.5601
72421224|NCT00514683|144353702|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.8|STANDARD_ERROR_OF_MEAN|1.694||0.6366|TWO_SIDED|95.0|-2.53|4.13|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||4.13|-2.53|0.6366
72329173|NCT00654745|144183278|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-19.1|||<|0.0001|TWO_SIDED|95.0|-21.1|-17.1||last 4 hours mean SBP change from baseline to week 12.|t-test, 2 sided|standard 1-sample confidence interval construction using t-distribution with 164 degrees of freedom||Primary null hypothesis is change from baseline to week12 in ABPM is 0. Change from baseline to week12 is primary efficacy variable and used all ABPM subjects. Null hypothesis used 1-sample t-test on change. Sample size of 200 expected to provide 99% power at significance level of 0.05%.||-17.1|-21.1|<0.0001
72421225|NCT00514683|144353702|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.84|STANDARD_ERROR_OF_MEAN|1.702||0.0246|TWO_SIDED|95.0|0.49|7.18|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||7.18|0.49|0.0246
72421226|NCT00514683|144353702|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.44|STANDARD_ERROR_OF_MEAN|1.7||0.0015|TWO_SIDED|95.0|2.1|8.78|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||8.78|2.10|0.0015
72421227|NCT00514683|144353703|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.911||||0.7543|TWO_SIDED|95.0|0.506|1.637|||Regression, Logistic|Logistic regression model with fixed terms for treatment, baseline of corresponding continuous value, region.|Odds ratio lower than 1 favours the treatment group over placebo.|||1.637|0.506|0.7543
72421228|NCT00514683|144353703|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.136||||0.6704|TWO_SIDED|95.0|0.631|2.045|||Regression, Logistic|Logistic regression model with fixed terms for treatment, baseline of corresponding continuous value, region.|Odds ratio lower than 1 favours the treatment group over placebo.|||2.045|0.631|0.6704
72421229|NCT00514683|144353703|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.657||||0.1649|TWO_SIDED|95.0|0.363|1.189|||Regression, Logistic|Logistic regression model with fixed terms for treatment, baseline of corresponding continuous value, region.|Odds ratio lower than 1 favours the treatment group over placebo.|||1.189|0.363|0.1649
72421230|NCT00514683|144353703|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.415||||0.0041|TWO_SIDED|95.0|0.227|0.757|||Regression, Logistic|Logistic regression model with fixed terms for treatment, baseline of corresponding continuous value, region.|Odds ratio lower than 1 favours the treatment group over placebo.|||0.757|0.227|0.0041
72421231|NCT00514683|144353704|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.278||||0.5882|TWO_SIDED|95.0|0.526|3.102|||Regression, Cox|Cox regression model with fixed terms for treatment, gender, age, height, region.|Hazard ratio lower than 1 favours the treatment group over placebo.|||3.102|0.526|0.5882
72421232|NCT00514683|144353704|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.29||||0.0653|TWO_SIDED|95.0|0.078|1.081|||Regression, Cox|Cox regression model with fixed terms for treatment, gender, age, height, region.|Hazard ratio lower than 1 favours the treatment group over placebo.|||1.081|0.078|0.0653
72421233|NCT00514683|144353704|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.35||||0.0847|TWO_SIDED|95.0|0.106|1.154|||Regression, Cox|Cox regression model with fixed terms for treatment, gender, age, height, region.|Hazard ratio lower than 1 favours the treatment group over placebo.|||1.154|0.106|0.0847
72421234|NCT00514683|144353704|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.732||||0.5383|TWO_SIDED|95.0|0.271|1.977|||Regression, Cox|Cox regression model with fixed terms for treatment, gender, age, height, region.|Hazard ratio lower than 1 favours the treatment group over placebo.|||1.977|0.271|0.5383
72421235|NCT00514683|144353705|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.44|STANDARD_ERROR_OF_MEAN|0.483||0.3658|TWO_SIDED|95.0|-0.51|1.39|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||1.39|-0.51|0.3658
72421236|NCT00514683|144353705|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.33|STANDARD_ERROR_OF_MEAN|0.478||0.4956|TWO_SIDED|95.0|-0.61|1.27|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||1.27|-0.61|0.4956
72421237|NCT00514683|144353705|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.36|STANDARD_ERROR_OF_MEAN|0.482||0.0051|TWO_SIDED|95.0|0.41|2.31|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||2.31|0.41|0.0051
72421238|NCT00514683|144353705|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.12|STANDARD_ERROR_OF_MEAN|0.483||0.0211|TWO_SIDED|95.0|0.17|2.07|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||2.07|0.17|0.0211
72421239|NCT00514683|144353706|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.428||||0.1021|TWO_SIDED|95.0|0.155|1.184|||Regression, Logistic|Logistic regression model with fixed terms for treatment, baseline of corresponding continuous value, region.|Odds ratio lower than 1 favours the treatment group over placebo.|||1.184|0.155|0.1021
72421240|NCT00514683|144353706|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.682||||0.4318|TWO_SIDED|95.0|0.262|1.773|||Regression, Logistic|Logistic regression model with fixed terms for treatment, baseline of corresponding continuous value, region.|Odds ratio lower than 1 favours the treatment group over placebo.|||1.773|0.262|0.4318
72421241|NCT00514683|144353706|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.412||||0.0934|TWO_SIDED|95.0|0.146|1.161|||Regression, Logistic|Logistic regression model with fixed terms for treatment, baseline of corresponding continuous value, region.|Odds ratio lower than 1 favours the treatment group over placebo.|||1.161|0.146|0.0934
72421242|NCT00514683|144353706|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.313||||0.0317|TWO_SIDED|95.0|0.108|0.903|||Regression, Logistic|Logistic regression model with fixed terms for treatment, baseline of corresponding continuous value, region.|Odds ratio lower than 1 favours the treatment group over placebo.|||0.903|0.108|0.0317
72421243|NCT00514683|144353707|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.08|STANDARD_ERROR_OF_MEAN|2.33||0.6443|TWO_SIDED|95.0|-5.66|3.51|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||3.51|-5.66|0.6443
72329174|NCT00654745|144183278|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-19.5|||<|0.0001|TWO_SIDED|95.0|-21.7|-17.4||last 2 hours mean SBP change from baseline to week 12.|t-test, 2 sided|standard 1-sample confidence interval construction using t-distribution with 164 degrees of freedom||Primary null hypothesis is change from baseline to week12 in ABPM is 0. Change from baseline to week12 is primary efficacy variable and used all ABPM subjects. Null hypothesis used 1-sample t-test on change. Sample size of 200 expected to provide 99% power at significance level of 0.05%.||-17.4|-21.7|<0.0001
72329175|NCT00654745|144183279|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-10.3|||<|0.0001|TWO_SIDED|95.0|-12.0|-8.6||Change in mean seated systolic blood pressure from baseline to week 3.|t-test, 2 sided|standard 1-sample confidence interval construction using t-distribution with n-1 degrees of freedom||Primary null hypothesis is change from baseline is 0. Null hypothesis used 1-sample t-test on change. Sample size of 200 expected to provide 99% power at significance level of 0.05%.||-8.6|-12.0|<0.0001
72329176|NCT00654745|144183279|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-17.9|||<|0.0001|TWO_SIDED|95.0|-19.8|-16.1||Change in mean seated systolic blood pressure from baseline to week 6.|t-test, 2 sided|standard 1-sample confidence interval construction using t-distribution with n-1 degrees of freedom||Primary null hypothesis is change from baseline is 0. Null hypothesis used 1-sample t-test on change. Sample size of 200 expected to provide 99% power at significance level of 0.05%.||-16.1|-19.8|<0.0001
72329177|NCT00654745|144183279|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-20.0|||<|0.0001|TWO_SIDED|95.0|-22.2|-17.8||Change in mean seated systolic blood pressure from baseline to week 9|t-test, 2 sided|standard 1-sample confidence interval construction using t-distribution with n-1 degrees of freedom||Primary null hypothesis is change from baseline is 0. Null hypothesis used 1-sample t-test on change. Sample size of 200 expected to provide 99% power at significance level of 0.05%.||-17.8|-22.2|<0.0001
72329178|NCT00654745|144183279|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-23.7|||<|0.0001|TWO_SIDED|95.0|-25.7|-21.7||Change in mean seated systolic blood pressure from baseline to week 12|t-test, 2 sided|standard 1-sample confidence interval construction using t-distribution with n-1 degrees of freedom||Primary null hypothesis is change from baseline is 0. Null hypothesis used 1-sample t-test on change. Sample size of 200 expected to provide 99% power at significance level of 0.05%.||-21.7|-25.7|<0.0001
72329179|NCT00654745|144183279|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-28.5|||<|0.0001|TWO_SIDED|95.0|-30.8|-26.2||Change in mean seated systolic blood pressure from baseline to week 15|t-test, 2 sided|standard 1-sample confidence interval construction using t-distribution with n-1 degrees of freedom||Primary null hypothesis is change from baseline is 0. Null hypothesis used 1-sample t-test on change. Sample size of 200 expected to provide 99% power at significance level of 0.05%.||-26.2|-30.8|<0.0001
72329180|NCT00654745|144183279|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-31.1|||<|0.0001|TWO_SIDED|95.0|-33.3|-28.8||Change in mean seated systolic blood pressure from baseline to week 18|t-test, 2 sided|standard 1-sample confidence interval construction using t-distribution with n-1 degrees of freedom||Primary null hypothesis is change from baseline is 0. Null hypothesis used 1-sample t-test on change. Sample size of 200 expected to provide 99% power at significance level of 0.05%.||-28.8|-33.3|<0.0001
72329181|NCT00654745|144183280|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.1|||<|0.0001|TWO_SIDED|95.0|-5.1|-3.1||Change in mean seated diastolic blood pressure from baseline to week 3.|t-test, 2 sided|standard 1-sample confidence interval construction using t-distribution with n-1 degrees of freedom||Primary null hypothesis is change from baseline is 0. Null hypothesis used 1-sample t-test on change. Sample size of 200 expected to provide 99% power at significance level of 0.05%.||-3.1|-5.1|<0.0001
72329182|NCT00654745|144183280|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-8.2|||<|0.0001|TWO_SIDED|95.0|-9.4|-7.1||Change in mean seated diastolic blood pressure from baseline to week 6|t-test, 2 sided|standard 1-sample confidence interval construction using t-distribution with n-1 degrees of freedom||Primary null hypothesis is change from baseline is 0. Null hypothesis used 1-sample t-test on change. Sample size of 200 expected to provide 99% power at significance level of 0.05%.||-7.1|-9.4|<0.0001
72329183|NCT00654745|144183280|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-9.7|||<|0.0001|TWO_SIDED|95.0|-10.9|-8.4||Change in mean seated diastolic blood pressure from baseline to week 9|t-test, 2 sided|standard 1-sample confidence interval construction using t-distribution with n-1 degrees of freedom||Primary null hypothesis is change from baseline is 0. Null hypothesis used 1-sample t-test on change. Sample size of 200 expected to provide 99% power at significance level of 0.05%.||-8.4|-10.9|<0.0001
72421244|NCT00514683|144353707|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.31|STANDARD_ERROR_OF_MEAN|2.28||0.5656|TWO_SIDED|95.0|-5.8|3.18|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||3.18|-5.80|0.5656
72421245|NCT00514683|144353707|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.23|STANDARD_ERROR_OF_MEAN|2.24||0.9181|TWO_SIDED|95.0|-4.18|4.64|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||4.64|-4.18|0.9181
72421246|NCT00514683|144353707|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.93|STANDARD_ERROR_OF_MEAN|2.387||0.697|TWO_SIDED|95.0|-3.77|5.63|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||5.63|-3.77|0.6970
72329184|NCT00654745|144183280|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-11.2|||<|0.0001|TWO_SIDED|95.0|-12.5|-9.9||Change in mean seated diastolic blood pressure from baseline to week 12|t-test, 2 sided|standard 1-sample confidence interval construction using t-distribution with n-1 degrees of freedom||Primary null hypothesis is change from baseline is 0. Null hypothesis used 1-sample t-test on change. Sample size of 200 expected to provide 99% power at significance level of 0.05%.||-9.9|-12.5|<0.0001
72421247|NCT00514683|144353708|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.06|STANDARD_ERROR_OF_MEAN|2.49||0.9811|TWO_SIDED|95.0|-4.84|4.96|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||4.96|-4.84|0.9811
72421248|NCT00514683|144353708|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.01|STANDARD_ERROR_OF_MEAN|2.412||0.6772|TWO_SIDED|95.0|-3.74|5.75|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||5.75|-3.74|0.6772
72329185|NCT00654745|144183280|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-14.4|||<|0.0001|TWO_SIDED|95.0|-15.7|-13.1||Change in mean seated diastolic blood pressure from baseline to week 15|t-test, 2 sided|standard 1-sample confidence interval construction using t-distribution with n-1 degrees of freedom||Primary null hypothesis is change from baseline is 0. Null hypothesis used 1-sample t-test on change. Sample size of 200 expected to provide 99% power at significance level of 0.05%.||-13.1|-15.7|<0.0001
72329186|NCT00654745|144183280|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-15.1|||<|0.0001|TWO_SIDED|95.0|-16.5|-13.6||Change in mean seated diastolic blood pressure from baseline to week 18|t-test, 2 sided|standard 1-sample confidence interval construction using t-distribution with n-1 degrees of freedom||Primary null hypothesis is change from baseline is 0. Null hypothesis used 1-sample t-test on change. Sample size of 200 expected to provide 99% power at significance level of 0.05%.||-13.6|-16.5|<0.0001
72329187|NCT00383331|144183367|SUPERIORITY_OR_OTHER|||||||0.48||95.0|||||Fisher Exact|||The response rates are separately evaluated for these two treatment arms. For each arm, a sample size of 48 achieves 91% power to detect a difference of 20% between the null hypothesis of 15% response rate and the alternative hypothesis of 35% using a one-sided, binomial hypothesis test with a target significance level of 2.5% (the actual significance level is 2.2%).||||0.48
72329188|NCT00383331|144183372|SUPERIORITY_OR_OTHER|||||||0.56||95.0|||||Log Rank|||||||0.56
72329189|NCT04852055|144183384|SUPERIORITY||average marginal effect|-2.8|||||TWO_SIDED|95.0|-6.1|0.5||||||||0.5|-6.1|
72329190|NCT04852055|144183385|SUPERIORITY||average marginal effect|-0.6|||||TWO_SIDED|95.0|-3.0|1.8||||||||1.8|-3.0|
72329191|NCT02550288|144183433|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Means|-36.3|||<|0.001|TWO_SIDED|95.0|-40.5|-32.2|||Constrained longitudinal data analysis|||||-32.2|-40.5|<0.001
72329192|NCT02550288|144183433|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Means|-11.6|||<|0.001|TWO_SIDED|95.0|-14.9|-8.2|||Constrained longitudinal data analysis|||||-8.2|-14.9|<0.001
72329193|NCT02550288|144183433|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Means|-39.9|||<|0.001|TWO_SIDED|95.0|-44.1|-35.8|||Constrained longitudinal data analysis|||||-35.8|-44.1|<0.001
72329194|NCT02550288|144183433|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Means|-10.1|||<|0.001|TWO_SIDED|95.0|-13.5|-6.8|||Constrained longitudinal data analysis|||||-6.8|-13.5|<0.001
72329195|NCT03629223|144183473|EQUIVALENCE|Analysis was performed with Equivalence acceptance range for 90% confidence interval (CI) as 80.00% - 125.00%. In the below, LS-means = least squares mean.|Percentage of Ratio of Geometric LS-Mean|115.35|||||TWO_SIDED|90.0|108.55|122.58||||||||122.58|108.55|
72329196|NCT03629223|144183473|OTHER||Percentage of ratio of Geometric LS-Mean|186.37|||||TWO_SIDED|90.0|163.61|212.28||||||||212.28|163.61|
72329197|NCT03629223|144183473|OTHER||Percentage of ratio of Geometric LS-Mean|163.15|||||TWO_SIDED|90.0|146.17|182.1||||||||182.10|146.17|
72329198|NCT03629223|144183474|EQUIVALENCE|Analysis was performed with Equivalence acceptance range for 90% confidence interval (CI) as 80.00% - 125.00%.|Percentage of ratio of Geometric LS-Mean|115.34|||||TWO_SIDED|90.0|108.51|122.6||||||||122.60|108.51|
72329199|NCT03629223|144183474|OTHER||Percentage of ratio of Geometric LS-Mean|186.67|||||TWO_SIDED|90.0|163.78|212.77||||||||212.77|163.78|
72329200|NCT03629223|144183474|OTHER||Percentage of ratio of Geometric LS-Mean|163.26|||||TWO_SIDED|90.0|146.09|182.46||||||||182.46|146.09|
72329201|NCT03629223|144183475|EQUIVALENCE|Analysis was performed with equivalence acceptance range for 90% confidence interval (CI) as 80.00% - 125.00%.|Percentage of ratio of Geometric LS-Mean|113.57|||||TWO_SIDED|90.0|107.62|119.85||||||||119.85|107.62|
72329202|NCT03629223|144183475|OTHER||Percentage of ratio of Geometric LS-Mean|236.51|||||TWO_SIDED|90.0|215.69|259.34||||||||259.34|215.69|
72329203|NCT03629223|144183475|OTHER||Percentage of ratio of Geometric LS-Mean|199.61|||||TWO_SIDED|90.0|176.44|225.82||||||||225.82|176.44|
72421249|NCT00514683|144353708|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.41|STANDARD_ERROR_OF_MEAN|2.379||0.8631|TWO_SIDED|95.0|-4.27|5.09|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||5.09|-4.27|0.8631
72421250|NCT00514683|144353708|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.35|STANDARD_ERROR_OF_MEAN|2.523||0.5942|TWO_SIDED|95.0|-3.62|6.31|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||6.31|-3.62|0.5942
72421251|NCT00514683|144353709|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.79|STANDARD_ERROR_OF_MEAN|0.715||0.2716|TWO_SIDED|95.0|-0.62|2.19|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||2.19|-0.62|0.2716
72421252|NCT00514683|144353709|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.19|STANDARD_ERROR_OF_MEAN|0.696||0.7871|TWO_SIDED|95.0|-1.18|1.56|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||1.56|-1.18|0.7871
72421253|NCT00514683|144353709|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.11|STANDARD_ERROR_OF_MEAN|0.685||0.8721|TWO_SIDED|95.0|-1.46|1.24|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||1.24|-1.46|0.8721
72421254|NCT00514683|144353709|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.14|STANDARD_ERROR_OF_MEAN|0.734||0.8523|TWO_SIDED|95.0|-1.58|1.31|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||1.31|-1.58|0.8523
72421255|NCT00514683|144353710|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.093||||0.7997|TWO_SIDED|95.0|0.549|2.175|||Regression, Logistic|Logistic regression model with fixed terms for treatment, baseline of corresponding continuous value, region.|Odds ratio lower than 1 favours the treatment group over placebo.|||2.175|0.549|0.7997
72421256|NCT00514683|144353710|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.916||||0.7989|TWO_SIDED|95.0|0.467|1.797|||Regression, Logistic|Logistic regression model with fixed terms for treatment, baseline of corresponding continuous value, region.|Odds ratio lower than 1 favours the treatment group over placebo.|||1.797|0.467|0.7989
72421257|NCT00514683|144353710|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.78||||0.4596|TWO_SIDED|95.0|0.403|1.508|||Regression, Logistic|Logistic regression model with fixed terms for treatment, baseline of corresponding continuous value, region.|Odds ratio lower than 1 favours the treatment group over placebo.|||1.508|0.403|0.4596
72421258|NCT00514683|144353710|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.665||||0.2548|TWO_SIDED|95.0|0.33|1.341|||Regression, Logistic|Logistic regression model with fixed terms for treatment, baseline of corresponding continuous value, region.|Odds ratio lower than 1 favours the treatment group over placebo.|||1.341|0.330|0.2548
72421259|NCT00514683|144353711|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.051||||0.8887|TWO_SIDED|95.0|0.521|2.122|||Regression, Logistic|Logistic regression model with fixed terms for treatment, baseline of corresponding continuous value, region.|Odds ratio lower than 1 favours the treatment group over placebo.|||2.122|0.521|0.8887
72421260|NCT00514683|144353711|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.216||||0.5758|TWO_SIDED|95.0|0.613|2.41|||Regression, Logistic|Logistic regression model with fixed terms for treatment, baseline of corresponding continuous value, region.|Odds ratio lower than 1 favours the treatment group over placebo.|||2.410|0.613|0.5758
72421261|NCT00514683|144353711|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.993||||0.9829|TWO_SIDED|95.0|0.506|1.949|||Regression, Logistic|Logistic regression model with fixed terms for treatment, baseline of corresponding continuous value, region.|Odds ratio lower than 1 favours the treatment group over placebo.|||1.949|0.506|0.9829
72421262|NCT00514683|144353711|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.972||||0.9375|TWO_SIDED|95.0|0.476|1.985|||Regression, Logistic|Logistic regression model with fixed terms for treatment, baseline of corresponding continuous value, region.|Odds ratio lower than 1 favours the treatment group over placebo.|||1.985|0.476|0.9375
72421263|NCT00514683|144353712|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.098|STANDARD_ERROR_OF_MEAN|0.1456||0.4998|TWO_SIDED|95.0|-0.188|0.385|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||0.385|-0.188|0.4998
72421264|NCT00514683|144353712|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.155|STANDARD_ERROR_OF_MEAN|0.1399||0.2679|TWO_SIDED|95.0|-0.43|0.12|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||0.120|-0.430|0.2679
72421265|NCT00514683|144353712|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.08|STANDARD_ERROR_OF_MEAN|0.14||0.5678|TWO_SIDED|95.0|-0.355|0.195|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||0.195|-0.355|0.5678
72421266|NCT00514683|144353712|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.121|STANDARD_ERROR_OF_MEAN|0.1448||0.4053|TWO_SIDED|95.0|-0.406|0.164|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||0.164|-0.406|0.4053
72421267|NCT00514683|144353713|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.892||||0.7307|TWO_SIDED|95.0|0.465|1.71|||Regression, Logistic|An ordinal logistic regression model with fixed terms for treatment, baseline of corresponding continuous value, region.|Odds ratio lower than 1 favours the treatment group over placebo.|||1.710|0.465|0.7307
72421268|NCT00514683|144353713|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.317||||0.3869|TWO_SIDED|95.0|0.706|2.458|||Regression, Logistic|An ordinal logistic regression model with fixed terms for treatment, baseline of corresponding continuous value, region.|Odds ratio lower than 1 favours the treatment group over placebo.|||2.458|0.706|0.3869
72421269|NCT00514683|144353713|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.931||||0.8237|TWO_SIDED|95.0|0.498|1.741|||Regression, Logistic|An ordinal logistic regression model with fixed terms for treatment, baseline of corresponding continuous value, region.|Odds ratio lower than 1 favours the treatment group over placebo.|||1.741|0.498|0.8237
72421270|NCT00514683|144353713|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.676||||0.1177|TWO_SIDED|95.0|0.878|3.202|||Regression, Logistic|An ordinal logistic regression model with fixed terms for treatment, baseline of corresponding continuous value, region.|Odds ratio lower than 1 favours the treatment group over placebo.|||3.202|0.878|0.1177
72421271|NCT00514683|144353714|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-11.24|STANDARD_ERROR_OF_MEAN|17.089||0.5111|TWO_SIDED|95.0|-44.86|22.37|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||22.37|-44.86|0.5111
72421272|NCT00514683|144353714|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.17|STANDARD_ERROR_OF_MEAN|16.234||0.4176|TWO_SIDED|95.0|-45.11|18.76|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||18.76|-45.11|0.4176
72421273|NCT00514683|144353714|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.13|STANDARD_ERROR_OF_MEAN|16.506||0.9454|TWO_SIDED|95.0|-33.6|31.34|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||31.34|-33.60|0.9454
72421274|NCT00514683|144353714|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.32|STANDARD_ERROR_OF_MEAN|16.98||0.7101|TWO_SIDED|95.0|-27.08|39.72|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||39.72|-27.08|0.7101
72421275|NCT00514683|144353715|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.055|STANDARD_ERROR_OF_MEAN|0.2271||0.809|TWO_SIDED|95.0|-0.392|0.502|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Positive change indicates worsening.|||0.502|-0.392|0.8090
72421276|NCT00514683|144353715|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.182|STANDARD_ERROR_OF_MEAN|0.2158||0.3995|TWO_SIDED|95.0|-0.606|0.242|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Positive change indicates worsening.|||0.242|-0.606|0.3995
72421277|NCT00514683|144353715|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.033|STANDARD_ERROR_OF_MEAN|0.2193||0.8822|TWO_SIDED|95.0|-0.399|0.464|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Positive change indicates worsening.|||0.464|-0.399|0.8822
72421278|NCT00514683|144353715|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.141|STANDARD_ERROR_OF_MEAN|0.2257||0.5338|TWO_SIDED|95.0|-0.584|0.303|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Positive change indicates worsening.|||0.303|-0.584|0.5338
72421279|NCT00514683|144353716|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.112|STANDARD_ERROR_OF_MEAN|0.3272||0.7329|TWO_SIDED|95.0|-0.532|0.755|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Positive change indicates worsening.|||0.755|-0.532|0.7329
72421280|NCT00514683|144353716|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.078|STANDARD_ERROR_OF_MEAN|0.3109||0.8009|TWO_SIDED|95.0|-0.69|0.533|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Positive change indicates worsening.|||0.533|-0.690|0.8009
72421281|NCT00514683|144353716|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.15|STANDARD_ERROR_OF_MEAN|0.3159||0.6358|TWO_SIDED|95.0|-0.771|0.472|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Positive change indicates worsening.|||0.472|-0.771|0.6358
72421282|NCT00514683|144353716|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.333|STANDARD_ERROR_OF_MEAN|0.3252||0.3064|TWO_SIDED|95.0|-0.973|0.307|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Positive change indicates worsening.|||0.307|-0.973|0.3064
72421283|NCT00514683|144353717|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.014||||0.9646|TWO_SIDED|95.0|0.54|1.906|||Regression, Logistic|An ordinal logistic regression model with fixed terms for treatment, baseline of corresponding continuous value, region.|Odds ratio lower than 1 favours the treatment group over placebo. Negative change indicates worsening.|||1.906|0.540|0.9646
72421284|NCT00514683|144353717|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.994||||0.985|TWO_SIDED|95.0|0.536|1.844|||Regression, Logistic|An ordinal logistic regression model with fixed terms for treatment, baseline of corresponding continuous value, region.|Odds ratio lower than 1 favours the treatment group over placebo. Negative change indicates worsening.|||1.844|0.536|0.9850
72421285|NCT00514683|144353717|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.123||||0.7136|TWO_SIDED|95.0|0.604|2.089|||Regression, Logistic|An ordinal logistic regression model with fixed terms for treatment, baseline of corresponding continuous value, region.|Odds ratio lower than 1 favours the treatment group over placebo. Negative change indicates worsening.|||2.089|0.604|0.7136
72421286|NCT00514683|144353717|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.551||||0.1705|TWO_SIDED|95.0|0.828|2.906|||Regression, Logistic|An ordinal logistic regression model with fixed terms for treatment, baseline of corresponding continuous value, region.|Odds ratio lower than 1 favours the treatment group over placebo. Negative change indicates worsening.|||2.906|0.828|0.1705
72421287|NCT00514683|144353718|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.35|STANDARD_ERROR_OF_MEAN|0.68||0.0479|TWO_SIDED|95.0|-2.69|-0.01|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated.|||-0.01|-2.69|0.0479
72421288|NCT00514683|144353718|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.24|STANDARD_ERROR_OF_MEAN|0.68||0.0685|TWO_SIDED|95.0|-2.58|0.09|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated.|||0.09|-2.58|0.0685
72421289|NCT00514683|144353718|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.77|STANDARD_ERROR_OF_MEAN|0.684||0.0099|TWO_SIDED|95.0|-3.12|-0.43|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated.|||-0.43|-3.12|0.0099
72421290|NCT00514683|144353718|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.67|STANDARD_ERROR_OF_MEAN|0.683||0.0152|TWO_SIDED|95.0|-3.01|-0.32|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated.|||-0.32|-3.01|0.0152
72421291|NCT00514683|144353719|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.79|STANDARD_ERROR_OF_MEAN|2.253||0.725|TWO_SIDED|95.0|-5.22|3.64|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Positive change indicates worsening.|||3.64|-5.22|0.7250
72421292|NCT00514683|144353719|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.28|STANDARD_ERROR_OF_MEAN|2.213||0.1389|TWO_SIDED|95.0|-7.63|1.07|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Positive change indicates worsening.|||1.07|-7.63|0.1389
72421293|NCT00514683|144353719|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.98|STANDARD_ERROR_OF_MEAN|2.221||0.0741|TWO_SIDED|95.0|-8.35|0.39|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Positive change indicates worsening.|||0.39|-8.35|0.0741
72421294|NCT00514683|144353719|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.12|STANDARD_ERROR_OF_MEAN|2.262||0.0071|TWO_SIDED|95.0|-10.57|-1.67|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Positive change indicates worsening.|||-1.67|-10.57|0.0071
72421295|NCT00514683|144353720|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.06|STANDARD_ERROR_OF_MEAN|3.183||0.337|TWO_SIDED|95.0|-9.32|3.2|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Positive change indicates worsening.|||3.20|-9.32|0.3370
72421296|NCT00514683|144353720|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.34|STANDARD_ERROR_OF_MEAN|3.126||0.1659|TWO_SIDED|95.0|-10.49|1.81|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Positive change indicates worsening.|||1.81|-10.49|0.1659
72329204|NCT02674464|144183494|SUPERIORITY||Odds Ratio (OR)|0.9||||0.68|TWO_SIDED|95.0|0.62|1.3||The a priori threshold for statistical significance was \<0.05.|Generalized Estimating Equations (GEE)|Assuming an exchangeable correlation structure|CC/SC arm compared to the SCP arm.|||1.30|0.62|0.68
72329205|NCT02674464|144183495|SUPERIORITY||Mean Difference (Final Values)|0.49||||0.6|TWO_SIDED|95.0|-1.32|2.3||The a priori threshold for statistical significance was \<0.05.|Mixed Effects Regression||CC/SC arm was compared to the SCP arm.|||2.30|-1.32|0.60
72329206|NCT02674464|144183496|SUPERIORITY||Mean Difference (Final Values)|0.83||||0.38|TWO_SIDED|95.0|-1.04|2.71||The a priori threshold for statistical significance was \<0.05.|Mixed Effects Regression|||||2.71|-1.04|0.38
72329207|NCT02674464|144183497|SUPERIORITY||Mean Difference (Final Values)|-1.2||||0.05|TWO_SIDED|95.0|-2.43|0.01||The a priori threshold for statistical significance was \<0.05.|Mixed Effects Regression||CC/SC arm compared to SCP arm.|||0.01|-2.43|0.05
72329208|NCT04660552|144183544|EQUIVALENCE|The post treatment cars scores of active and sham group will be statistically different as measured by independent sample t-test with p\<.05|Mean Difference (Net)|7.23|STANDARD_DEVIATION|4.2||0.01|TWO_SIDED|95.0|2.357|12.107|||t-test, 2 sided|||||12.107|2.357|0.01
72329209|NCT00191945|144183581|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-7.9|STANDARD_ERROR_OF_MEAN|1.6|<|0.001||95.0|-11.0|-4.8|||Mixed Models Analysis|Mixed Model Repeated Measures analysis method: treatment, study site, visit, treatment-by-visit interaction, baseline, baseline-by-visit interaction.|Least Squares Mean difference at week 12 (Atomoxetine minus Placebo)|||-4.8|-11.0|<0.001
72329210|NCT00191945|144183582|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-6.5|STANDARD_ERROR_OF_MEAN|1.5|<|0.001||95.0|-9.5|-3.6|||Mixed Models Analysis|Mixed Model Repeated Measures analysis method: treatment, study site, visit, treatment-by-visit interaction, baseline, baseline-by-visit interaction.|Least Squares Mean difference at Week 9 (Atomoxetine - Placebo)|A gatekeeper strategy was employed for sequentially testing the secondary hypotheses using a REML-based Mixed-Model Repeated Measures (MMRM) technique as defined for the primary efficacy analyses. If primary hypothesis is significant at 0.05 (2-sided), first secondary hypothesis will be tested at Visit 6 from MMRM. If comparison is significant, subsequent secondary hypotheses will be tested in sequence until first null hypothesis fails to be rejected.||-3.6|-9.5|<0.001
72329211|NCT00191945|144183583|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.2|STANDARD_ERROR_OF_MEAN|1.5||0.0009||95.0|-8.2|-2.2|||Mixed Models Analysis|Mixed Model Repeated Measures analysis method: treatment, study site, visit, treatment-by-visit interaction, baseline, baseline-by-visit interaction.|Least Squares Mean difference at 6 weeks (Atomoxetine - Placebo)|A gatekeeper strategy was employed for sequentially testing the secondary hypotheses using a REML-based Mixed-Model Repeated Measures (MMRM) technique as defined for the primary efficacy analyses. If primary hypothesis is significant at 0.05 (2-sided), first secondary hypothesis will be tested at Visit 6 from MMRM. If comparison is significant, subsequent secondary hypotheses will be tested in sequence until first null hypothesis fails to be rejected.||-2.2|-8.2|0.0009
72421297|NCT00514683|144353720|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.12|STANDARD_ERROR_OF_MEAN|3.138||0.1897|TWO_SIDED|95.0|-10.29|2.05|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Positive change indicates worsening.|||2.05|-10.29|0.1897
72421298|NCT00514683|144353720|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.6|STANDARD_ERROR_OF_MEAN|3.184||0.0028|TWO_SIDED|95.0|-15.86|-3.34|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Positive change indicates worsening.|||-3.34|-15.86|0.0028
72421299|NCT00514683|144353721|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|2.586||0.8458|TWO_SIDED|95.0|-5.59|4.58|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Positive change indicates worsening.|||4.58|-5.59|0.8458
72421300|NCT00514683|144353721|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.48|STANDARD_ERROR_OF_MEAN|2.54||0.3286|TWO_SIDED|95.0|-7.48|2.51|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Positive change indicates worsening.|||2.51|-7.48|0.3286
72421301|NCT00514683|144353721|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.42|STANDARD_ERROR_OF_MEAN|2.548||0.1799|TWO_SIDED|95.0|-8.43|1.59|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Positive change indicates worsening.|||1.59|-8.43|0.1799
72421302|NCT00514683|144353721|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.35|STANDARD_ERROR_OF_MEAN|2.597||0.0948|TWO_SIDED|95.0|-9.46|0.76|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Positive change indicates worsening.|||0.76|-9.46|0.0948
72421303|NCT00514683|144353722|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.09|STANDARD_ERROR_OF_MEAN|2.484||0.9708|TWO_SIDED|95.0|-4.98|4.79|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Positive change indicates worsening.|||4.79|-4.98|0.9708
72421304|NCT00514683|144353722|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.94|STANDARD_ERROR_OF_MEAN|2.44||0.1069|TWO_SIDED|95.0|-8.74|0.85|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Positive change indicates worsening.|||0.85|-8.74|0.1069
72421305|NCT00514683|144353722|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.49|STANDARD_ERROR_OF_MEAN|2.453||0.0682|TWO_SIDED|95.0|-9.31|0.34|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Positive change indicates worsening.|||0.34|-9.31|0.0682
72421306|NCT00514683|144353722|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.16|STANDARD_ERROR_OF_MEAN|2.494||0.0043|TWO_SIDED|95.0|-12.06|-2.26|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Positive change indicates worsening.|||-2.26|-12.06|0.0043
72421307|NCT00514683|144353723|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.54||||0.2698|TWO_SIDED|95.0|0.72|3.31|||Cochran-Mantel-Haenszel|Based on an Cochran-Mantel-Haenszel test to adjust for region effect.|In case of missing data, patient has been set to non-responder. Odds ratio lower than 1 favours the treatment group over placebo.|||3.31|0.72|0.2698
72421308|NCT00514683|144353723|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.9||||0.0891|TWO_SIDED|95.0|0.9|4.01|||Cochran-Mantel-Haenszel|Based on an Cochran-Mantel-Haenszel test to adjust for region effect.|In case of missing data, patient has been set to non-responder. Odds ratio lower than 1 favours the treatment group over placebo.|||4.01|0.90|0.0891
72421309|NCT00514683|144353723|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.7||||0.0069|TWO_SIDED|95.0|1.29|5.66|||Cochran-Mantel-Haenszel|Based on an Cochran-Mantel-Haenszel test to adjust for region effect.|In case of missing data, patient has been set to non-responder. Odds ratio lower than 1 favours the treatment group over placebo.|||5.66|1.29|0.0069
72421310|NCT00514683|144353723|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.2||||0.0341|TWO_SIDED|95.0|1.05|4.61|||Cochran-Mantel-Haenszel|Based on an Cochran-Mantel-Haenszel test to adjust for region effect.|In case of missing data, patient has been set to non-responder. Odds ratio lower than 1 favours the treatment group over placebo.|||4.61|1.05|0.0341
72421311|NCT00514683|144353724|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.022|STANDARD_ERROR_OF_MEAN|0.1015||0.8288|TWO_SIDED|95.0|-0.178|0.222|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||0.222|-0.178|0.8288
72421312|NCT00514683|144353724|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.14|STANDARD_ERROR_OF_MEAN|0.0974||0.1506|TWO_SIDED|95.0|-0.051|0.332|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||0.332|-0.051|0.1506
72421313|NCT00514683|144353724|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.158|STANDARD_ERROR_OF_MEAN|0.0977||0.1059|TWO_SIDED|95.0|-0.034|0.351|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||0.351|-0.034|0.1059
72421314|NCT00514683|144353724|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.358|STANDARD_ERROR_OF_MEAN|0.1008||0.0004|TWO_SIDED|95.0|0.16|0.556|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||0.556|0.160|0.0004
72421315|NCT00514683|144353725|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.019|STANDARD_ERROR_OF_MEAN|0.068||0.7789|TWO_SIDED|95.0|-0.153|0.115|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Positive change indicates worsening.|||0.115|-0.153|0.7789
72421316|NCT00514683|144353725|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.066|STANDARD_ERROR_OF_MEAN|0.0652||0.3149|TWO_SIDED|95.0|-0.063|0.194|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Positive change indicates worsening.|||0.194|-0.063|0.3149
72421317|NCT00514683|144353725|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.025|STANDARD_ERROR_OF_MEAN|0.0654||0.7062|TWO_SIDED|95.0|-0.104|0.153|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Positive change indicates worsening.|||0.153|-0.104|0.7062
72421318|NCT00514683|144353725|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.123|STANDARD_ERROR_OF_MEAN|0.0675||0.0703|TWO_SIDED|95.0|-0.01|0.255|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Positive change indicates worsening.|||0.255|-0.010|0.0703
72421319|NCT00514683|144353726|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.063|STANDARD_ERROR_OF_MEAN|0.0884||0.4792|TWO_SIDED|95.0|-0.111|0.236|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||0.236|-0.111|0.4792
72421320|NCT00514683|144353726|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.103|STANDARD_ERROR_OF_MEAN|0.0839||0.2221|TWO_SIDED|95.0|-0.062|0.268|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||0.268|-0.062|0.2221
72421321|NCT00514683|144353726|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.121|STANDARD_ERROR_OF_MEAN|0.0843||0.151|TWO_SIDED|95.0|-0.044|0.287|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||0.287|-0.044|0.1510
72421322|NCT00514683|144353726|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.337|STANDARD_ERROR_OF_MEAN|0.0874||0.0001|TWO_SIDED|95.0|0.165|0.509|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||0.509|0.165|0.0001
72329212|NCT00191945|144183584|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.8|STANDARD_ERROR_OF_MEAN|1.3||0.0033||95.0|-6.4|-1.3|||Mixed Models Analysis|Mixed Model Repeated Measures analysis method: treatment, study site, visit, treatment-by-visit interaction, baseline, baseline-by-visit interaction.|Least Squares Mean difference at 4 weeks (Atomoxetine - Placebo)|A gatekeeper strategy was employed for sequentially testing the secondary hypotheses using a REML-based Mixed-Model Repeated Measures (MMRM) technique as defined for the primary efficacy analyses. If primary hypothesis is significant at 0.05 (2-sided), first secondary hypothesis will be tested at Visit 6 from MMRM. If comparison is significant, subsequent secondary hypotheses will be tested in sequence until first null hypothesis fails to be rejected.||-1.3|-6.4|0.0033
72329213|NCT00191945|144183585|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.7|STANDARD_ERROR_OF_MEAN|1.1||0.013||95.0|-4.9|-0.6||P-value is for the difference between groups in the change from 12 weeks minus 6 weeks.|Mixed Models Analysis|Mixed Model Repeated Measures analysis method: treatment, study site, visit, treatment-by-visit interaction, baseline, baseline-by-visit interaction.|Least Squares Mean difference between groups (Atomoxetine - Placebo) in change from 6 weeks to 12 weeks|A gatekeeper strategy was employed for sequentially testing the secondary hypotheses using a REML-based Mixed-Model Repeated Measures (MMRM) technique as defined for the primary efficacy analyses. If primary hypothesis is significant at 0.05 (2-sided), first secondary hypothesis will be tested at Visit 6 from MMRM. If comparison is significant, subsequent secondary hypotheses will be tested in sequence until first null hypothesis fails to be rejected.||-0.6|-4.9|0.013
72329214|NCT00191945|144183588|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-10.7|STANDARD_ERROR_OF_MEAN|2.3|<|0.001||95.0|-15.1|-6.2||P-value is for the difference between groups in the change from 12 weeks minus baseline.|Mixed Models Analysis|mixed model repeated measures analyis: treatment, visit, patient, and CPRS-R: S Total score at baseline as covariate, with treatment\*visit interaction|Least Squares Mean difference between groups (Atomoxetine - Placebo) in change from baseline to 12 weeks.|||-6.2|-15.1|<0.001
72329215|NCT00191945|144183589|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.47||||0.81||95.0|-3.39|4.33||P-value for Parent: Satisfaction difference (Atomoxetine - Placebo) in the change from 12 weeks minus baseline.|ANCOVA|||ANCOVA model: Dependent variable=standardized mean scores of domain at Visit 7 minus scores at Visit 1; Factors=Treatment, Investigator, Rater; Covariate=standardized mean scores of domain at Visit 1. Both treatment by rater and treatment by covariate interaction terms included in model.||4.33|-3.39|0.810
72329216|NCT00191945|144183589|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.96||||0.243||95.0|-1.35|5.29||P-value for Parent: Comfort difference (Atomoxetine - Placebo) in the change from 12 weeks minus baseline.|ANCOVA|||ANCOVA model: Dependent variable=standardized mean scores of domain at Visit 7 minus scores at Visit 1; Factors=Treatment, Investigator, Rater; Covariate=standardized mean scores of domain at Visit 1. Both treatment by rater and treatment by covariate interaction terms included in model.||5.29|-1.35|0.243
72329217|NCT00191945|144183589|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.56||||0.419||95.0|-2.26|5.39||P-value for Parent: Resilience difference (Atomoxetine - Placebo) in the change from 12 weeks minus baseline.|ANCOVA|||ANCOVA model: Dependent variable=standardized mean scores of domain at Visit 7 minus scores at Visit 1; Factors=Treatment, Investigator, Rater; Covariate=standardized mean scores of domain at Visit 1. Both treatment by rater and treatment by covariate interaction terms included in model.||5.39|-2.26|0.419
72329218|NCT00191945|144183589|SUPERIORITY_OR_OTHER||Mean Difference (Net)|8.41|||<|0.001||95.0|4.27|12.55||P-value for Parent:Risk Avoidance difference (Atomoxetine - Placebo) in the change from 12 weeks minus baseline.|ANCOVA|||ANCOVA model: Dependent variable=standardized mean scores of domain at Visit 7 minus scores at Visit 1; Factors=Treatment, Investigator, Rater; Covariate=standardized mean scores of domain at Visit 1. Both treatment by rater and treatment by covariate interaction terms included in model.||12.55|4.27|<0.001
72329219|NCT00191945|144183589|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.39||||0.042||95.0|0.13|6.65||P-value for Parent:Achievement difference (Atomoxetine - Placebo) in the change from 12 weeks minus baseline.|ANCOVA|||ANCOVA model: Dependent variable=standardized mean scores of domain at Visit 7 minus scores at Visit 1; Factors=Treatment, Investigator, Rater; Covariate=standardized mean scores of domain at Visit 1. Both treatment by rater and treatment by covariate interaction terms included in model.||6.65|0.13|0.042
72329220|NCT00191945|144183589|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.36||||0.323||95.0|-4.06|1.35||P-value for Child/Adolescent:Satisfaction difference (Atomoxetine - Placebo) in the change from 12 weeks minus baseline.|ANCOVA|||ANCOVA model: Dependent variable=standardized mean scores of domain at Visit 7 minus scores at Visit 1; Factors=Treatment, Investigator, Rater; Covariate=standardized mean scores of domain at Visit 1. Both treatment by rater and treatment by covariate interaction terms included in model.||1.35|-4.06|0.323
72421323|NCT00514683|144353727|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.097|STANDARD_ERROR_OF_MEAN|0.0609||0.1129|TWO_SIDED|95.0|-0.023|0.217|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||0.217|-0.023|0.1129
72329221|NCT00191945|144183589|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.92||||0.452||95.0|-1.49|3.34||P-value for Child/Adolescent:Comfort difference (Atomoxetine - Placebo) in the change from 12 weeks minus baseline.|ANCOVA|||ANCOVA model: Dependent variable=standardized mean scores of domain at Visit 7 minus scores at Visit 1; Factors=Treatment, Investigator, Rater; Covariate=standardized mean scores of domain at Visit 1. Both treatment by rater and treatment by covariate interaction terms included in model.||3.34|-1.49|0.452
72421324|NCT00514683|144353727|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.084|STANDARD_ERROR_OF_MEAN|0.0584||0.1498|TWO_SIDED|95.0|-0.031|0.199|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||0.199|-0.031|0.1498
72421325|NCT00514683|144353727|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.109|STANDARD_ERROR_OF_MEAN|0.0585||0.0632|TWO_SIDED|95.0|-0.006|0.224|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||0.224|-0.006|0.0632
72421326|NCT00514683|144353727|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.201|STANDARD_ERROR_OF_MEAN|0.0604||0.0009|TWO_SIDED|95.0|0.083|0.32|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||0.320|0.083|0.0009
72421327|NCT00514683|144353728|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.033|STANDARD_ERROR_OF_MEAN|0.0676||0.6306|TWO_SIDED|95.0|-0.165|0.1|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||0.100|-0.165|0.6306
72421328|NCT00514683|144353728|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.021|STANDARD_ERROR_OF_MEAN|0.065||0.7426|TWO_SIDED|95.0|-0.149|0.106|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||0.106|-0.149|0.7426
72421329|NCT00514683|144353728|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.006|STANDARD_ERROR_OF_MEAN|0.0651||0.9209|TWO_SIDED|95.0|-0.134|0.121|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||0.121|-0.134|0.9209
72421330|NCT00514683|144353728|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.0671||0.7701|TWO_SIDED|95.0|-0.112|0.152|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||0.152|-0.112|0.7701
72421331|NCT00514683|144353729|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.83||||0.6671|TWO_SIDED|95.0|0.36|1.93||Based on the statistic of ln(risk ratio) having a normal distribution N\[0,\[ (1/number with at least one exacerbation in Nintedanib group) + (1//number with at least one exacerbation in placebo) \] \]|Negative binomial model|Default log link function and adjusted for an off-set variable (logarithm of the follow-up time), for gender, height, age and region as fixed effects.|Risk ratio lower than 1 favours the treatment group over placebo.|||1.93|0.36|0.6671
72421332|NCT00514683|144353729|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.8||||0.5926|TWO_SIDED|95.0|0.34|1.84||Based on the statistic of ln(risk ratio) having a normal distribution N\[0,\[ (1/number with at least one exacerbation in Nintedanib group) + (1//number with at least one exacerbation in placebo) \] \]|Negative binomial model|Default log link function and adjusted for an off-set variable (logarithm of the follow-up time), for gender, height, age and region as fixed effects.|Risk ratio lower than 1 favours the treatment group over placebo.|||1.84|0.34|0.5926
72421333|NCT00514683|144353729|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.48||||0.1381|TWO_SIDED|95.0|0.18|1.27||Based on the statistic of ln(risk ratio) having a normal distribution N\[0,\[ (1/number with at least one exacerbation in Nintedanib group) + (1//number with at least one exacerbation in placebo) \] \]|Negative binomial model|Default log link function and adjusted for an off-set variable (logarithm of the follow-up time), for gender, height, age and region as fixed effects.|Risk ratio lower than 1 favours the treatment group over placebo.|||1.27|0.18|0.1381
72421334|NCT00514683|144353729|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.16||||0.015|TWO_SIDED|95.0|0.03|0.7||Based on the statistic of ln(risk ratio) having a normal distribution N\[0,\[ (1/number with at least one exacerbation in Nintedanib group) + (1//number with at least one exacerbation in placebo) \] \]|Negative binomial model|Default log link function and adjusted for an off-set variable (logarithm of the follow-up time), for gender, height, age and region as fixed effects.|Risk ratio lower than 1 favours the treatment group over placebo.|||0.70|0.03|0.0150
72421335|NCT00514683|144353730|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.9||||0.8282|TWO_SIDED|95.0|0.347|2.336|||Negative binomial model||Risk ratio is actually Rate Ratio. Rate ratio is calculated based on Negative binomial model with default log link function and adjusted for an off-set variable and age, height, gender, region (all effects fixed).|||2.336|0.347|0.8282
72421336|NCT00514683|144353730|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.73||||0.5326|TWO_SIDED|95.0|0.278|1.938|||Negative Binomial model||Risk ratio is actually Rate Ratio. Rate ratio is calculated based on Negative binomial model with default log link function and adjusted for an off-set variable and age, height, gender, region (all effects fixed).|||1.938|0.278|0.5326
72421337|NCT00514683|144353730|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.49||||0.1944|TWO_SIDED|95.0|0.167|1.438|||Negative Binomial model||Risk ratio is actually Rate Ratio. Rate ratio is calculated based on Negative binomial model with default log link function and adjusted for an off-set variable and age, height, gender, region (all effects fixed).|||1.438|0.167|0.1944
72421338|NCT00514683|144353730|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.22||||0.0324|TWO_SIDED|95.0|0.056|0.882|||Negative Binomial model||Risk ratio is actually Rate Ratio. Rate ratio is calculated based on Negative binomial model with default log link function and adjusted for an off-set variable and age, height, gender, region (all effects fixed).|||0.882|0.056|0.0324
72421339|NCT00514683|144353731|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.758||||0.5206|TWO_SIDED|95.0|0.326|1.765|||Regression, Cox|Cox regression model with fixed terms for treatment, gender, age, height, region.|Hazard ratio lower than 1 favours the treatment group over placebo.|||1.765|0.326|0.5206
72421340|NCT00514683|144353731|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.841||||0.6862|TWO_SIDED|95.0|0.362|1.952|||Regression, Cox|Cox regression model with fixed terms for treatment, gender, age, height, region.|Hazard ratio lower than 1 favours the treatment group over placebo.|||1.952|0.362|0.6862
72421341|NCT00514683|144353731|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.517||||0.1891|TWO_SIDED|95.0|0.193|1.384|||Regression, Cox|Cox regression model with fixed terms for treatment, gender, age, height, region.|Hazard ratio lower than 1 favours the treatment group over placebo.|||1.384|0.193|0.1891
72421342|NCT00514683|144353731|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.158||||0.0161|TWO_SIDED|95.0|0.035|0.711|||Regression, Cox|Cox regression model with fixed terms for treatment, gender, age, height, region.|Hazard ratio lower than 1 favours the treatment group over placebo.|||0.711|0.035|0.0161
72421343|NCT00514683|144353732|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.173||||0.7449|TWO_SIDED|95.0|0.448|3.072|||Regression, Cox|Cox regression model with fixed terms for treatment, gender, age, height, region.|Hazard ratio lower than 1 favours the treatment group over placebo.|||3.072|0.448|0.7449
72329222|NCT00191945|144183589|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.16||||0.91||95.0|-2.59|2.9||P-value for Child/Adolescent:Resilience difference (Atomoxetine - Placebo) in the change from 12 weeks minus baseline.|ANCOVA|||ANCOVA model: Dependent variable=standardized mean scores of domain at Visit 7 minus scores at Visit 1; Factors=Treatment, Investigator, Rater; Covariate=standardized mean scores of domain at Visit 1. Both treatment by rater and treatment by covariate interaction terms included in model.||2.90|-2.59|0.910
72329223|NCT00191945|144183589|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.56||||0.006||95.0|1.04|6.08||P-value for Child/Adolescent:Risk Avoidance difference (Atomoxetine - Placebo) in the change from 12 weeks minus baseline.|ANCOVA|||ANCOVA model: Dependent variable=standardized mean scores of domain at Visit 7 minus scores at Visit 1; Factors=Treatment, Investigator, Rater; Covariate=standardized mean scores of domain at Visit 1. Both treatment by rater and treatment by covariate interaction terms included in model.||6.08|1.04|0.006
72421344|NCT00514683|144353732|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.316||||0.0925|TWO_SIDED|95.0|0.083|1.209|||Regression, Cox|Cox regression model with fixed terms for treatment, gender, age, height, region.|Hazard ratio lower than 1 favours the treatment group over placebo.|||1.209|0.083|0.0925
72421345|NCT00514683|144353732|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.19||||0.0379|TWO_SIDED|95.0|0.04|0.911|||Regression, Cox|Cox regression model with fixed terms for treatment, gender, age, height, region.|Hazard ratio lower than 1 favours the treatment group over placebo.|||0.911|0.040|0.0379
72329224|NCT00191945|144183589|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.99||||0.541||95.0|-2.21|4.19||P-value for Child/Adolescent:Achievement difference (Atomoxetine - Placebo) in the change from 12 weeks minus baseline.|ANCOVA|||ANCOVA model: Dependent variable=standardized mean scores of domain at Visit 7 minus scores at Visit 1; Factors=Treatment, Investigator, Rater; Covariate=standardized mean scores of domain at Visit 1. Both treatment by rater and treatment by covariate interaction terms included in model.||4.19|-2.21|0.541
72329225|NCT01576939|144183654|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.0||||0.9906|TWO_SIDED|95.0|0.979|1.022|||Regression, Cox|This was a Cox proportional hazards model with dose as the single predictor.||||1.022|0.979|0.9906
72329226|NCT01576939|144183655|SUPERIORITY_OR_OTHER||Slope|0.2795||||0.1209|TWO_SIDED|95.0|-0.077|0.634|||Regression, Linear|Linear regression model with dose as the single predictor in the model.||||0.634|-0.077|0.1209
72329227|NCT01576939|144183656|SUPERIORITY_OR_OTHER||Slope|-0.285||||0.9832|TWO_SIDED|95.0|-27.28|26.71|||Regression, Linear|Linear regression model with dose as the single predictor in the model.||||26.71|-27.28|0.9832
72329228|NCT01576939|144183657|SUPERIORITY_OR_OTHER||Slope|0.03795||||0.0263|TWO_SIDED|95.0|0.00483|0.071|||Mixed Models Analysis|A repeated measures model with dose as the single predictor. QoL values were measured for each patient every week.||||0.071|0.00483|0.0263
72329229|NCT01576939|144183658|SUPERIORITY_OR_OTHER||Slope|0.0567||||0.0039|TWO_SIDED|95.0|0.0199|0.0935|||Mixed Models Analysis|A repeated measures model with dose as the single predictor and QoL values measured each week for each patient.||||0.0935|0.0199|0.0039
72329230|NCT02470585|144183666|SUPERIORITY|Multiplicity considerations included 3 treatment arms, (2 pairwise comparisons), 3 sequentially inclusive populations (BRCA-mutation population, HRD population, and ITT population), and multiple endpoints. A fixed-sequence testing procedure was used to control the Type I error rate at 0.05 from the primary efficacy endpoints sequentially through the secondary efficacy endpoints.|Hazard Ratio (HR)|0.435|||<|0.001|TWO_SIDED|95.0|0.277|0.683||A 2-sided p-value of ≤ 0.05 was considered statistically significant in the following hierarchical testing sequence: PFS was to be compared first in the BRCA-mutation cohort, then in the HRD cohort, and then in the ITT population.|Log Rank|Stratified according to residual disease status and disease stage.|Cox proportional hazards model stratified according to the same factors as those used in the log-rank test above.|The primary efficacy analyses compared investigator-assessed PFS in the Veliparib + Carboplatin + Paclitaxel -\> Veliparib group (Arm 3) vs. the Placebo + Carboplatin + Paclitaxel -\> Placebo group (Arm 1).||0.683|0.277|<0.001
72329231|NCT02470585|144183667|SUPERIORITY|Multiplicity considerations included 3 treatment arms, (2 pairwise comparisons), 3 sequentially inclusive populations (BRCA-mutation population, HRD population, and ITT population), and multiple endpoints. A fixed-sequence testing procedure was used to control the Type I error rate at 0.05 from the primary efficacy endpoints sequentially through the secondary efficacy endpoints.|Hazard Ratio (HR)|0.572|||<|0.001|TWO_SIDED|95.0|0.433|0.756||A 2-sided p-value of ≤ 0.05 was considered statistically significant in the following hierarchical testing sequence: PFS was to be compared first in the BRCA-mutation cohort, then in the HRD cohort, and then in the ITT population.|Log Rank|Stratified according to residual disease status and disease stage.|Cox proportional hazards model stratified according to the same factors as those used in the log-rank test above.|The primary efficacy analyses compared investigator-assessed PFS in the Veliparib + Carboplatin + Paclitaxel -\> Veliparib group (Arm 3) vs. the Placebo + Carboplatin + Paclitaxel -\> Placebo group (Arm 1).||0.756|0.433|<0.001
72329232|NCT02470585|144183668|SUPERIORITY|Multiplicity considerations included 3 treatment arms, (2 pairwise comparisons), 3 sequentially inclusive populations (BRCA-mutation population, HRD population, and ITT population), and multiple endpoints. A fixed-sequence testing procedure was used to control the Type I error rate at 0.05 from the primary efficacy endpoints sequentially through the secondary efficacy endpoints.|Hazard Ratio (HR)|0.683|||<|0.001|TWO_SIDED|95.0|0.562|0.831||A 2-sided p-value of ≤ 0.05 was considered statistically significant in the following hierarchical testing sequence: PFS was to be compared first in the BRCA-mutation cohort, then in the HRD cohort, and then in the ITT population.|Log Rank|Stratified according to residual disease status and disease stage, choice of the paclitaxel regimen, and BRCA-mutation status|Cox proportional hazards model stratified according to the same factors as those used in the log-rank test above.|The primary efficacy analyses compared investigator-assessed PFS in the Veliparib + Carboplatin + Paclitaxel -\> Veliparib group (Arm 3) vs. the Placebo + Carboplatin + Paclitaxel -\> Placebo group (Arm 1).||0.831|0.562|<0.001
72329233|NCT02470585|144183669|SUPERIORITY|Multiplicity considerations included 3 treatment arms, (2 pairwise comparisons), 3 sequentially inclusive populations (BRCA-mutation population, HRD population, and ITT population), and multiple endpoints. A fixed-sequence testing procedure was used to control the Type I error rate at 0.05 from the primary efficacy endpoints sequentially through the secondary efficacy endpoints.|Hazard Ratio (HR)|1.215||||0.335|TWO_SIDED|95.0|0.821|1.799|||Log Rank|Stratified according to residual disease status and disease stage.|Cox proportional hazards model stratified according to the same factors as those used in the log-rank test above.|The secondary efficacy analyses compared investigator-assessed PFS in the Veliparib + Carboplatin + Paclitaxel -\> Placebo group (Arm 2) vs. the Placebo + Carboplatin + Paclitaxel -\> Placebo group (Arm 1).||1.799|0.821|0.335
72329234|NCT02470585|144183670|SUPERIORITY|Multiplicity considerations included 3 treatment arms, (2 pairwise comparisons), 3 sequentially inclusive populations (BRCA-mutation population, HRD population, and ITT population), and multiple endpoints. A fixed-sequence testing procedure was used to control the Type I error rate at 0.05 from the primary efficacy endpoints sequentially through the secondary efficacy endpoints.|Hazard Ratio (HR)|1.1||||0.462|TWO_SIDED|95.0|0.855|1.414|||Log Rank|Stratified according to residual disease status and disease stage.|Cox proportional hazards model stratified according to the same factors as those used in the log-rank test above.|The secondary efficacy analyses compared investigator-assessed PFS in the Veliparib + Carboplatin + Paclitaxel -\> Placebo group (Arm 2) vs. the Placebo + Carboplatin + Paclitaxel -\> Placebo group (Arm 1).||1.414|0.855|0.462
72329235|NCT02470585|144183671|SUPERIORITY|Multiplicity considerations included 3 treatment arms, (2 pairwise comparisons), 3 sequentially inclusive populations (BRCA-mutation population, HRD population, and ITT population), and multiple endpoints. A fixed-sequence testing procedure was used to control the Type I error rate at 0.05 from the primary efficacy endpoints sequentially through the secondary efficacy endpoints.|Hazard Ratio (HR)|1.073||||0.45|TWO_SIDED|95.0|0.895|1.287|||Log Rank|Stratified according to residual disease status and disease stage, choice of the paclitaxel regimen, and BRCA-mutation status|Cox proportional hazards model stratified according to the same factors as those used in the log-rank test above.|The secondary efficacy analyses compared investigator-assessed PFS in the Veliparib + Carboplatin + Paclitaxel -\> Placebo group (Arm 2) vs. the Placebo + Carboplatin + Paclitaxel -\> Placebo group (Arm 1).||1.287|0.895|0.450
72329236|NCT02470585|144183672|SUPERIORITY||Hazard Ratio (HR)|0.9||||0.328|TWO_SIDED|95.0|0.567|1.429||Stratified by residual disease (no residual disease after primary surgery versus any residual disease after primary surgery or interval surgery) and stage of disease (stage III versus stage IV)|Log Rank||Cox proportional hazards model stratified according to the same factors as those used in the log-rank test above|Veliparib + Carboplatin + Paclitaxel -\> Veliparib (Arm 3) versus Placebo + Carboplatin + Paclitaxel -\> Placebo (Arm 1)||1.429|0.567|0.328
72329237|NCT02470585|144183672|SUPERIORITY||Hazard Ratio (HR)|1.218||||0.808|TWO_SIDED|95.0|0.78|1.903||Stratified by residual disease (no residual disease after primary surgery versus any residual disease after primary surgery or interval surgery) and stage of disease (stage III versus stage IV)|Log Rank||Cox proportional hazards model stratified according to the same factors as those used in the log-rank test above.|Veliparib + Carboplatin + Paclitaxel -\> Placebo (Arm 2) versus Placebo + Carboplatin + Paclitaxel -\> Placebo (Arm 1)||1.903|0.780|0.808
72329238|NCT02470585|144183673|SUPERIORITY||Hazard Ratio (HR)|0.844||||0.116|TWO_SIDED|95.0|0.64|1.114||Stratified by residual disease (no residual disease after primary surgery versus any residual disease after primary surgery or interval surgery) and stage of disease (stage III versus stage IV)|Log Rank||Cox proportional hazards model stratified according to the same factors as those used in the log-rank test above.|Veliparib + Carboplatin + Paclitaxel -\> Veliparib (Arm 3) versus Placebo + Carboplatin + Paclitaxel -\> Placebo (Arm 1)||1.114|0.640|0.116
72329239|NCT02470585|144183673|SUPERIORITY||Hazard Ratio (HR)|0.949||||0.352|TWO_SIDED|95.0|0.726|1.242||Stratified by residual disease (no residual disease after primary surgery versus any residual disease after primary surgery or interval surgery) and stage of disease (stage III versus stage IV)|Log Rank||Cox proportional hazards model stratified according to the same factors as those used in the log-rank test above.|Veliparib + Carboplatin + Paclitaxel -\> Placebo (Arm 2) versus Placebo + Carboplatin + Paclitaxel -\> Placebo (Arm 1)||1.242|0.726|0.352
72329240|NCT02470585|144183674|SUPERIORITY||Hazard Ratio (HR)|0.946||||0.283|TWO_SIDED|95.0|0.782|1.144||Stratified by residual disease (none after primary surgery vs any residual disease after primary/interval surgery); disease stage (III vs IV); paclitaxel dosing (Q-weekly vs Q3-weekly); BRCA-Deficient status (Deficient vs wildtype or unknown/missing)|Log Rank|||Veliparib + Carboplatin + Paclitaxel -\> Veliparib (Arm 3) versus Placebo + Carboplatin + Paclitaxel -\> Placebo (Arm 1)||1.144|0.782|0.283
72329241|NCT02470585|144183674|SUPERIORITY||Hazard Ratio (HR)|1.034||||0.638|TWO_SIDED|95.0|0.859|1.244||Stratified by residual disease (none after primary surgery vs any residual disease after primary/interval surgery); disease stage (III vs IV); paclitaxel dosing (Q-weekly vs Q3-weekly); BRCA-Deficient status (Deficient vs wildtype or unknown/missing)|Log Rank||Cox proportional hazards model stratified according to the same factors as those used in the log-rank test above|Veliparib + Carboplatin + Paclitaxel -\> Placebo (Arm 2) versus Placebo + Carboplatin + Paclitaxel -\> Placebo (Arm 1)||1.244|0.859|0.638
72329242|NCT00434993|144183683|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.2|STANDARD_ERROR_OF_MEAN|1.3||0.087|TWO_SIDED|95.0|-4.7|0.3||The p-value was not adjusted for multiple comparisons.|ANCOVA|Adjusted for baseline shock.||The trial had a statistical power of 90.7% to detect a 2.25-day increase in VFDs,assuming a SD of 10.5 days. A group sequential design was used.||0.3|-4.7|0.087
72329243|NCT00434993|144183684|SUPERIORITY_OR_OTHER||Risk Difference (RD)|5.3||||0.302|TWO_SIDED|95.0|-4.0|14.7||The p-value was not adjusted for multiple comparisons.|Regression, Logistic|Adjusted for baseline shock.||||14.7|-4.0|0.302
72329244|NCT00434993|144183685|SUPERIORITY_OR_OTHER||Risk Difference (RD)|5.9||||0.261|TWO_SIDED|95.0|-3.7|15.4||The p-value was not adjusted for multiple comparisons.|Regression, Logistic|Adjusted for baseline shock.||||15.4|-3.7|0.261
72329245|NCT00434993|144183686|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.7||||0.023|TWO_SIDED|95.0|-4.9|-0.4||The p-value was not adjusted for multiple comparisons.|ANCOVA|Adjusted for baseline shock.||||-0.4|-4.9|0.023
72329246|NCT00434993|144183687|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.7||||0.226|TWO_SIDED|95.0|-4.3|0.9||The p-value was not adjusted for multiple comparisons.|ANCOVA|Adjusted for baseline shock.||||0.9|-4.3|0.226
72329247|NCT00434993|144183688|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.3||||0.13|TWO_SIDED|95.0|-5.3|0.6|||ANCOVA|Adjusted for baseline shock.||||0.6|-5.3|0.130
72329248|NCT00434993|144183689|SUPERIORITY_OR_OTHER||Risk Difference (RD)|8.2||||0.176|TWO_SIDED|95.0|-3.1|19.6|||Regression, Logistic|Adjusted for baseline shock.||||19.6|-3.1|0.176
72329249|NCT00434993|144183690|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.9||||0.048|TWO_SIDED|95.0|-7.8|0.0|||ANCOVA|||||-0.0|-7.8|0.048
72329250|NCT00434993|144183691|SUPERIORITY_OR_OTHER||Risk Difference (RD)|9.5||||0.265|TWO_SIDED|95.0|-6.9|25.9|||Regression, Logistic|||||25.9|-6.9|0.265
72329251|NCT02218697|144183705|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority criterion (for each of the 4 strains): UL of the 95% CI for the GMT ratio (Control Group / Co-Ad Group) does not exceed 2.0.|Adjusted GMT ratio|1.13|||||TWO_SIDED|95.0|0.88|1.46|||ANCOVA||The GMTs were used to calculate the Adjusted GMTs, which in turn were used to calculate the Adjusted GMT ratio with 95% confidence interval.|The adjusted GMT of HI antibodies for H1N1 strain at Day 28 post Influsplit™ Tetra vaccination, the GMT ratio of Control group/Co-Ad group and the two sided 95% CI were computed by fitting an ANCOVA model on the logarithm10 transformation of the titers, including the vaccine group as fixed effect and the pre-vaccination titer as covariate.||1.46|0.88|
72329252|NCT02218697|144183705|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority criterion (for each of the 4 strains): UL of the 95% CI for the GMT ratio (Control Group / Co-Ad Group) does not exceed 2.0.|Adjusted GMT ratio|0.97|||||TWO_SIDED|95.0|0.78|1.21|||ANCOVA||The GMTs were used to calculate the Adjusted GMTs, which in turn were used to calculate the Adjusted GMT ratio with 95% confidence interval.|The adjusted GMT of HI antibodies for H3N2 strain at Day 28 post Influsplit™ Tetra vaccination, the GMT ratio of Control group/Co-Ad group and the two sided 95% CI were computed by fitting an ANCOVA model on the logarithm10 transformation of the titers, including the vaccine group as fixed effect and the pre-vaccination titer as covariate.||1.21|0.78|
72329253|NCT02218697|144183705|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority criterion (for each of the 4 strains): UL of the 95% CI for the GMT ratio (Control Group / Co-Ad Group) does not exceed 2.0.|Adjusted GMT ratio|1.17|||||TWO_SIDED|95.0|0.98|1.4|||ANCOVA||The GMTs were used to calculate the Adjusted GMTs, which in turn were used to calculate the Adjusted GMT ratio with 95% confidence interval.|The adjusted GMT of HI antibodies for Victoria strain at Day 28 post Influsplit™ Tetra vaccination, the GMT ratio of Control group/Co-Ad group and the two sided 95% CI were computed by fitting an ANCOVA model on the logarithm10 transformation of the titers, including the vaccine group as fixed effect and the pre-vaccination titer as covariate.||1.40|0.98|
72329254|NCT02218697|144183705|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority criterion (for each of the 4 strains): UL of the 95% CI for the GMT ratio (Control Group / Co-Ad Group) does not exceed 2.0.|Adjusted GMT ratio|0.99|||||TWO_SIDED|95.0|0.84|1.16|||ANCOVA||The GMTs were used to calculate the Adjusted GMTs, which in turn were used to calculate the Adjusted GMT ratio with 95% confidence interval.|The adjusted GMT of HI antibodies for Yamagata strain at Day 28 post Influsplit™ Tetra vaccination, the GMT ratio of Control group/Co-Ad group and the two sided 95% CI were computed by fitting an ANCOVA model on the logarithm10 transformation of the titers, including the vaccine group as fixed effect and the pre-vaccination titer as covariate.||1.16|0.84|
72329255|NCT02218697|144183706|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority criterion (for each of six pneumococcal serotypes): UL of the 95% CI for the geometric mean concentration (GMC) ratio (Control group over Co-Ad group) does not exceed 2.0.|Adjusted GMC ratio|1.14|||||TWO_SIDED|95.0|0.86|1.5|||ANCOVA||The GMCs were used to calculate the Adjusted GMCs, which in turn were used to calculate the Adjusted GMC ratio with 95% confidence interval.|Anti-pneumococcal antibody concentrations for Polysaccharide 01 serotype at Day 28 post Pneumovax™ 23 vaccination, the GMC ratio of Control Group/Co-Ad Group and the two sided 95% CI were computed by fitting an ANCOVA model on the logarithm10 transformation of the titres/concentrations, including the vaccine group as fixed effect and the pre-vaccination titre/concentration as covariate.||1.50|0.86|
72329256|NCT02218697|144183706|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority criterion (for each of six pneumococcal serotypes): UL of the 95% CI for the geometric mean concentration (GMC) ratio (Control group over Co-Ad group) does not exceed 2.0.|Adjusted GMC ratio|1.18|||||TWO_SIDED|95.0|0.96|1.45|||ANCOVA||The GMCs were used to calculate the Adjusted GMCs, which in turn were used to calculate the Adjusted GMC ratio with 95% confidence interval.|Anti-pneumococcal antibody concentrations for Polysaccharide 03 serotype at Day 28 post Pneumovax™ 23 vaccination, the GMC ratio of Control Group/Co-Ad Group and the two sided 95% CI were computed by fitting an ANCOVA model on the logarithm10 transformation of the titres/concentrations, including the vaccine group as fixed effect and the pre-vaccination titre/concentration as covariate.||1.45|0.96|
72329257|NCT02218697|144183706|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority criterion (for each of six pneumococcal serotypes): UL of the 95% CI for the geometric mean concentration (GMC) ratio (Control group over Co-Ad group) does not exceed 2.0.|Adjusted GMC ratio|1.26|||||TWO_SIDED|95.0|0.98|1.62|||ANCOVA||The GMCs were used to calculate the Adjusted GMCs, which in turn were used to calculate the Adjusted GMC ratio with 95% confidence interval.|Anti-pneumococcal antibody concentrations for Polysaccharide 04 serotype at Day 28 post Pneumovax™ 23 vaccination, the GMC ratio of Control Group/Co-Ad Group and the two sided 95% CI were computed by fitting an ANCOVA model on the logarithm10 transformation of the titres/concentrations, including the vaccine group as fixed effect and the pre-vaccination titre/concentration as covariate.||1.62|0.98|
72329258|NCT02218697|144183706|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority criterion (for each of six pneumococcal serotypes): UL of the 95% CI for the geometric mean concentration (GMC) ratio (Control group over Co-Ad group) does not exceed 2.0.|Adjusted GMC ratio|1.24|||||TWO_SIDED|95.0|0.95|1.63|||ANCOVA||The GMCs were used to calculate the Adjusted GMCs, which in turn were used to calculate the Adjusted GMC ratio with 95% confidence interval.|Anti-pneumococcal antibody concentrations for Polysaccharide 7F serotype at Day 28 post Pneumovax™ 23 vaccination, the GMC ratio of Control Group/Co-Ad Group and the two sided 95% CI were computed by fitting an ANCOVA model on the logarithm10 transformation of the titres/concentrations, including the vaccine group as fixed effect and the pre-vaccination titre/concentration as covariate.||1.63|0.95|
72369788|NCT01621802|144249927|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The LL of the 2-sided 97.5% CI for the adjusted GMC ratio (Inv\_MMR\_CO group divided by pooled Com\_MMR\_CO group) was ≥ 0.67 for antibodies to measles, mumps and rubella viruses.|Adjusted GMC ratio|0.91|||||TWO_SIDED|97.5|0.83|1.0|||ANCOVA|Ancova model: adjustment for baseline concentration - pooled variance|The GMCs were used to calculate the Adjusted GMCs, which in turn were used to calculate the Adjusted GMC ratio with 97.5% confidence interval.|||1.00|0.83|
72421346|NCT00514683|144353732|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.225||||0.06|TWO_SIDED|95.0|0.048|1.065|||Regression, Cox|Cox regression model with fixed terms for treatment, gender, age, height, region.|Hazard ratio lower than 1 favours the treatment group over placebo.|||1.065|0.048|0.0600
72421347|NCT00514683|144353733|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.055||||0.7883|TWO_SIDED|95.0|0.713|1.563|||Regression, Cox|Cox regression model with fixed terms for treatment, gender, age, height, region.|Hazard ratio lower than 1 favours the treatment group over placebo.|||1.563|0.713|0.7883
72329259|NCT02218697|144183706|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority criterion (for each of six pneumococcal serotypes): UL of the 95% CI for the geometric mean concentration (GMC) ratio (Control group over Co-Ad group) does not exceed 2.0.|Adjusted GMC ratio|1.2|||||TWO_SIDED|95.0|0.91|1.57|||ANCOVA||The GMCs were used to calculate the Adjusted GMCs, which in turn were used to calculate the Adjusted GMC ratio with 95% confidence interval.|Anti-pneumococcal antibody concentrations for Polysaccharide 14 serotype at Day 28 post Pneumovax™ 23 vaccination, the GMC ratio of Control Group/Co-Ad Group and the two sided 95% CI were computed by fitting an ANCOVA model on the logarithm10 transformation of the titres/concentrations, including the vaccine group as fixed effect and the pre-vaccination titre/concentration as covariate.||1.57|0.91|
72421348|NCT00514683|144353733|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.958||||0.8293|TWO_SIDED|95.0|0.646|1.419|||Regression, Cox|Cox regression model with fixed terms for treatment, gender, age, height, region.|Hazard ratio lower than 1 favours the treatment group over placebo.|||1.419|0.646|0.8293
72421349|NCT00514683|144353733|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.805||||0.303|TWO_SIDED|95.0|0.534|1.216|||Regression, Cox|Cox regression model with fixed terms for treatment, gender, age, height, region.|Hazard ratio lower than 1 favours the treatment group over placebo.|||1.216|0.534|0.3030
72329260|NCT02218697|144183706|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority criterion (for each of six pneumococcal serotypes): UL of the 95% CI for the geometric mean concentration (GMC) ratio (Control group over Co-Ad group) does not exceed 2.0.|Adjusted GMC ratio|1.34|||||TWO_SIDED|95.0|1.05|1.7|||ANCOVA||The GMCs were used to calculate the Adjusted GMCs, which in turn were used to calculate the Adjusted GMC ratio with 95% confidence interval.|Anti-pneumococcal antibody concentrations for Polysaccharide 19A serotype at Day 28 post Pneumovax™ 23 vaccination, the GMC ratio of Control Group/Co-Ad Group and the two sided 95% CI were computed by fitting an ANCOVA model on the logarithm10 transformation of the titres/concentrations, including the vaccine group as fixed effect and the pre-vaccination titre/concentration as covariate.||1.70|1.05|
72329261|NCT03306433|144183735|EQUIVALENCE|The null hypothesis is that there are no significant paired differences between the groups. The power calculation is based on the observed variation and number of participants|Paired difference t-test|-12.139|STANDARD_DEVIATION|7.101||0.0003|TWO_SIDED|||||Paired difference p value comparing UDMA-K18 vs Adhesive Control|Paired difference test, 2 sided||There are 12 participants (pairs) for this comparison|Paired difference test within each participant.||||0.0003
72421350|NCT00514683|144353733|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.91||||0.6505|TWO_SIDED|95.0|0.605|1.369|||Regression, Cox|Cox regression model with fixed terms for treatment, gender, age, height, region.|Hazard ratio lower than 1 favours the treatment group over placebo.|||1.369|0.605|0.6505
72421351|NCT02736825|144353735|NON_INFERIORITY|Non-inferiority margin of 15% between two independent percentages using the z-test with unpooled variance||||||0.367|||||||Z-test|||||||0.3670
72421352|NCT01564368|144353754|SUPERIORITY||area under the curve (AUC)|0.53||||0.484|ONE_SIDED|95.0||0.61||Bonferroni's correction was used for multiple comparisons adjustment, where p\<0.003 (0.05/15) was considered statistically significant.|Z-test|The empirical AUC was tested by using variance derived from the method of DeLong|Receiver operating characteristic curve and AUC were estimated empirically, and its 95% CI was constructed using variance derived from DeLong's method|Receiver Operating Characteristic curves and the corresponding Area Under the Curve (AUC), were estimated for the change in Apparent Diffusion Coefficients (ADC1 - ADC0)/ADC0 (Test: %change in ADC; Reference: pCR) detect a difference of 0.15 between the AUC under H0: AUC=0.5 and an AUC under the alternative hypothesis of 0.65. It was assumed that the number of pCR non-responders would be approximately 2.7 times greater than the number of complete responders||0.61||0.484
72421353|NCT01564368|144353754|SUPERIORITY||area under the curve|0.6||||0.017|ONE_SIDED|95.0||0.68||Bonferroni's correction was used for multiple comparisons adjustment, where p\<0.003 (0.05/15) was considered statistically significant.|Z-test|The empirical AUC was tested by using variance derived from the method of DeLong|Receiver operating characteristic curve and AUC were estimated empirically, and its 95% CI was constructed using variance derived from DeLong's method|Receiver Operating Characteristic curves and the corresponding Area Under the Curve (AUC), were estimated for the change in Apparent Diffusion Coefficients (ADC2 - ADC0)/ADC0 (Test: %change in ADC; Reference: pCR) detect a difference of 0.15 between the AUC under H0: AUC=0.5 and an AUC under the alternative hypothesis of 0.65. It was assumed that the number of pCR non-responders would be approximately 2.7 times greater than the number of complete responders||0.68||0.017
72421354|NCT01564368|144353754|SUPERIORITY||area under the curve|0.61||||0.013|ONE_SIDED|95.0||0.69||Bonferroni's correction was used for multiple comparisons adjustment, where p\<0.003 (0.05/15) is considered statistically significant.|Z-test|The empirical AUC was tested by using variance derived from the method of DeLong|Receiver operating characteristic curve and AUC were estimated empirically, and its 95% CI was constructed using variance derived from DeLong's method|Receiver Operating Characteristic curves and the corresponding Area Under the Curve (AUC), were estimated for the change in Apparent Diffusion Coefficients (ADC3 - ADC0)/ADC0 (Test: %change in ADC; Reference: pCR) detect a difference of 0.15 between the AUC under H0: AUC=0.5 and an AUC under the alternative hypothesis of 0.65. It was assumed that the number of pCR non-responders would be approximately 2.7 times greater than the number of complete responders||0.69||0.013
72421355|NCT01564368|144353755|SUPERIORITY||area under the curve|0.68|||<|0.001|ONE_SIDED|95.0||0.75||Bonferroni's correction was used for multiple comparisons adjustment, where p\<0.003 (0.05/15) was considered statistically significant.|Z-test|The empirical AUC was tested by using variance derived from the method of DeLong|Receiver operating characteristic curve and AUC were estimated empirically, and its 95% CI was constructed using variance derived from DeLong's method|Receiver Operating Characteristic curves and the corresponding Area Under the Curve (AUC), were estimated for the change in functional tumor volumes (FTV1 - FTV0)/FTV0 (Test: %change in FTV; Reference: pCR) detect a difference of 0.15 between the AUC under H0: AUC=0.5 and an AUC under the alternative hypothesis of 0.65. It was assumed that the number of pCR non-responders would be approximately 2.7 times greater than the number of complete responders||0.75||<0.001
72421356|NCT01564368|144353755|SUPERIORITY||area under the curve|0.63|||<|0.001|ONE_SIDED|95.0||0.71||Bonferroni's correction was used for multiple comparisons adjustment, where p\<0.003 (0.05/15) was considered statistically significant.|Z-test|The empirical AUC was tested by using variance derived from the method of DeLong|Receiver operating characteristic curve and AUC were estimated empirically, and its 95% CI was constructed using variance derived from DeLong's method|Receiver Operating Characteristic curves and the corresponding Area Under the Curve (AUC), were estimated for the change in functional tumor volumes (FTV2 - FTV0)/FTV0 (Test: %change in FTV; Reference: pCR) detect a difference of 0.15 between the AUC under H0: AUC=0.5 and an AUC under the alternative hypothesis of 0.65. It was assumed that the number of pCR non-responders would be approximately 2.7 times greater than the number of complete responders||0.71||<0.001
72421357|NCT01564368|144353755|SUPERIORITY||area under the curve|0.68|||<|0.001|ONE_SIDED|95.0||0.75||Bonferroni's correction was used for multiple comparisons adjustment, where p\<0.003 (0.05/15) was considered statistically significant.|Z-test|The empirical AUC was tested by using variance derived from the method of DeLong|Receiver operating characteristic curve and AUC were estimated empirically, and its 95% CI was constructed using variance derived from DeLong's method|Receiver Operating Characteristic curves and the corresponding Area Under the Curve (AUC), were estimated for the change in functional tumor volumes (FTV3 - FTV0)/FTV0 (Test: %change in FTV; Reference: pCR) detect a difference of 0.15 between the AUC under H0: AUC=0.5 and an AUC under the alternative hypothesis of 0.65. It was assumed that the number of pCR non-responders would be approximately 2.7 times greater than the number of complete responders||0.75||<0.001
72421358|NCT01564368|144353756|EQUIVALENCE|no equivalence margin was used.||||||0.032|||||||z-test|||AUC (optimized) = AUC (ΔADC)||||0.032
72421359|NCT05674890|144353778|EQUIVALENCE|"Any deviation greater that +/- 0.60 (Effect size/Stdev OR 0.15/0.25=0.60) between device means was considered non-equivalent."|Mean Difference (Net)|-0.29|STANDARD_DEVIATION|2.49||0.297|TWO_SIDED||||||t-test, 2 sided|||Prior to patient enrollment, a power calculation was conducted to assess the ability of our analyses to reliably detect differences between the HFA and SSVR. With a sample size of 80, assumed effect size of 0.15, standard deviation of 0.25, intraclass correlation coefficient of 0.50, and significance level of 0.05, our analysis reaches a power of 0.87.||||0.297
72421360|NCT05674890|144353779|EQUIVALENCE|"Any deviation greater that +/- 0.60 (Effect size/Stdev OR 0.15/0.25=0.60) between device means was considered non-equivalent."|Mean Difference (Net)|-2.11|STANDARD_DEVIATION|2.81|<|0.001|TWO_SIDED||||||t-test, 2 sided|||Prior to patient enrollment, a power calculation was conducted to assess the ability of our analyses to reliably detect differences between the HFA and SSVR. With a sample size of 80, assumed effect size of 0.15, standard deviation of 0.25, intraclass correlation coefficient of 0.50, and significance level of 0.05, our analysis reaches a power of 0.87.||||<0.001
72421361|NCT05674890|144353780|EQUIVALENCE|"Any deviation greater that +/- 0.60 (Effect size/Stdev OR 0.15/0.25=0.60) between device means was considered non-equivalent."|Mean Difference (Net)|-48.75|STANDARD_DEVIATION|56.48|<|0.001|TWO_SIDED||||||t-test, 2 sided|||Prior to patient enrollment, a power calculation was conducted to assess the ability of our analyses to reliably detect differences between the HFA and SSVR. With a sample size of 80, assumed effect size of 0.15, standard deviation of 0.25, intraclass correlation coefficient of 0.50, and significance level of 0.05, our analysis reaches a power of 0.87.||||<0.001
72421362|NCT00520975|144353788|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.73||||0.24|TWO_SIDED|95.0|0.43|1.23|||Regression, Cox|||||1.23|0.43|0.24
72421363|NCT00520975|144353789|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.09||||0.75|TWO_SIDED|95.0|0.61|1.97|||Regression, Cox|||||1.97|0.61|0.75
72421364|NCT04810221|144353799|OTHER|Paired T-test 0|Mean Difference (Final Values)|0.18||||0.31|TWO_SIDED|95.0|-0.17|0.54|||Paired T-test 0||||Additional statistical analysis were: Bland Altman plot and linear regression analysis.|0.54|-0.17|0.31
72421365|NCT04810221|144353800|OTHER|Paired T test 0|Mean Difference (Final Values)|0.25||||0.32|TWO_SIDED|95.0|-0.24|0.75|||Paired T test 0||||Additional statistical analysis were: Bland Altman plot and linear regression analysis.|0.75|-0.24|0.32
72421366|NCT00105235|144353813|SUPERIORITY_OR_OTHER||Proportion|0.22|||||TWO_SIDED|95.0|0.086|0.423|||Exact Binomial Confidence Interval|||||.423|.086|
72421367|NCT00105235|144353814|SUPERIORITY_OR_OTHER||Proportion|0.0|||||TWO_SIDED|95.0|0.0|0.3|||Exact Binomial Confidence Interval|||||0.3|0|
72421368|NCT00105235|144353816|SUPERIORITY_OR_OTHER||Proportion|0.2|||||TWO_SIDED|95.0|0.04|0.3|||Exact Binomial Confidence Interval|||||0.3|0.04|
72421369|NCT00105235|144353817|SUPERIORITY_OR_OTHER||Proportion|0.1|||||TWO_SIDED|95.0|0.01|0.2|||Exact Binomial Confidence Interval|||||0.2|0.01|
72421370|NCT03532308|144353831|SUPERIORITY|||||||0.76||||||This is for the effect of treatment with time, risk stratification and treatment\*time interaction in the model.|Mixed Models Analysis|||||||0.76
72421371|NCT00499863|144353837|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||The null hypothesis was that there is no difference between MTS and placebo.||||< 0.001
72421372|NCT00499863|144353838|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||||||< 0.001
72421373|NCT00499863|144353839|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||||||< 0.001
72421374|NCT00499863|144353840|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||||||< 0.001
72421375|NCT00499863|144353841|SUPERIORITY_OR_OTHER|||||||0.288||95.0|||||ANCOVA|||||||0.288
72421376|NCT00571701|144353849|SUPERIORITY_OR_OTHER|||||||0.57|||||||Wilcoxon (Mann-Whitney)|||||||0.57
72421377|NCT00571701|144353850|SUPERIORITY_OR_OTHER|||||||0.43|||||||Fisher Exact|||||||0.43
72421378|NCT00571701|144353851|SUPERIORITY_OR_OTHER||||||>|0.3||||||Adjusted for multiple comparisons|Fisher Exact|||||||>0.3
72421379|NCT00571701|144353852|SUPERIORITY_OR_OTHER|||||||1||||||Adjusted for multiple comparisons|Fisher Exact|||||||1.00
72421380|NCT00571701|144353853|SUPERIORITY_OR_OTHER||||||>|0.5||||||Adjusted for multiple comparisons|Fisher Exact|||||||> 0.5
72421381|NCT00571701|144353854|SUPERIORITY_OR_OTHER||||||>|0.56|||||||t-test, 2 sided|||||||>0.56
72421382|NCT05701995|144353864|SUPERIORITY||Odds Ratio (OR)|7.7||||0.0001|TWO_SIDED|95.0|2.5|23.6|||Stratified Cochran-Mantel-Haenszel (CMH)|||Full Analysis Set||23.6|2.5|0.0001
72421383|NCT05701995|144353864|SUPERIORITY||Odds Ratio (OR)|8.5||||0.0003|TWO_SIDED|95.0|2.4|30.4|||Stratified Cochran-Mantel-Haenszel (CMH)|||Full Analysis Set Sub-population||30.4|2.4|0.0003
72421384|NCT05701995|144353865|SUPERIORITY||Odds Ratio (OR)|2.3||||0.0107|TWO_SIDED|95.0|1.2|4.4|||Stratified Cochran-Mantel-Haenszel (CMH)|||Full Analysis Set||4.4|1.2|0.0107
72421385|NCT05701995|144353865|SUPERIORITY||Odds Ratio (OR)|2.3||||0.0175|TWO_SIDED|95.0|1.2|4.7|||Stratified Cochran-Mantel-Haenszel (CMH)|||Full Analysis Set Sub-population||4.7|1.2|0.0175
72421386|NCT05701995|144353866|SUPERIORITY||Adjusted Mean Difference|-2.0|||<|0.0001|TWO_SIDED|95.0|-2.9|-1.2|||Covariance model|||Full Analysis Set||-1.2|-2.9|<0.0001
72421387|NCT05701995|144353866|SUPERIORITY||Adjusted Mean Difference|-2.2|||<|0.0001|TWO_SIDED|95.0|-3.0|-1.3|||Covariance model|||Full Analysis Set Sub-population||-1.3|-3.0|<0.0001
72421388|NCT05701995|144353867|SUPERIORITY||Odds Ratio (OR)|5.9||||0.0004|TWO_SIDED|95.0|2.0|17.4|||Stratified Cochran-Mantel-Haenszel (CMH)|||Full Analysis Set Sub-population||17.4|2.0|0.0004
72421389|NCT01091948|144353875|SUPERIORITY_OR_OTHER|||||||0.19|TWO_SIDED||||||Regression, Cox|Intubations accomplished with another device due to difficulty with assigned device and those took \>180 s were considered as failed intubations.||||||0.19
72421390|NCT01091948|144353876|SUPERIORITY_OR_OTHER||Ratio of Geometric Means|0.89||||0.58|TWO_SIDED|95.0|0.58|1.35|||ANCOVA||The mean intubation difficulty score was tested after logarithmic transformation, and then back transformed for the estimated treatment effect.|||1.35|0.58|0.58
72421391|NCT01091948|144353877|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.13||||0.15|TWO_SIDED|95.0|0.95|1.33|||Cochran-Mantel-Haenszel|||||1.33|0.95|0.15
72421392|NCT01091948|144353878|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.67||||0.57|TWO_SIDED|95.0|0.28|10.2|||Cochran-Mantel-Haenszel|||||10.2|0.28|0.57
72421393|NCT01091948|144353879|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.01||||0.79|TWO_SIDED|95.0|0.93|1.09|||Cochran-Mantel-Haenszel|||||1.09|0.93|0.79
72421394|NCT01091948|144353880|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.11||||0.82|TWO_SIDED|95.0|0.45|2.76|||Regression, Logistic|proportional odds logistic regression model||||2.76|0.45|0.82
72421395|NCT04803214|144353882|SUPERIORITY||||||<|0.001|TWO_SIDED|95.0|||||t-test, 2 sided|||||||<0.001
72421396|NCT04803214|144353883|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
72421397|NCT04803214|144353884|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
72421398|NCT00079001|144353903|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Superiority and futility analysis were conducted for time to first SRE. Lan-Demets analog of the Emerson-Fleming sequential boundary was used to maintain overall significance level of α = .05 while conducting interim analyses on time to first SRE.|Hazard Ratio (HR)|0.97||||0.385|TWO_SIDED|95.0|0.0|1.174||Because of early termination, conditional power was performed under the alternative hypothesis. This is the probability that zoledronic acid is superior to placebo, given time to first SRE data at interim analysis under alternative hypothesis.|Log Rank||Patients randomly assigned to zoledronic acid were compared with patients assigned to placebo|The null hypothesis was that the hazard ratio is greater than or equal to 1.0 versus the alternative hypothesis that the hazard ratio is less than 0.77. With a target of 470 SREs, log-rank statistic had 88% power to detect a 23% decrease in hazard of SRE (equivalent to an increase in median time to SRE from 30 months to 39 months), assuming a one-sided type I error rate of .05.||1.174|0|0.385
72421399|NCT00079001|144353904|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.88||||0.29|TWO_SIDED|95.0|0.7|1.12|||Log Rank|Adjusted for stratification factors: performance status, prior SRE, and serum alkaline phosphatase.|Zoledronic acid versus placebo group|||1.12|0.70|0.29
72421400|NCT00079001|144353905|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.89||||0.22|TWO_SIDED|95.0|0.74|1.07|||Log Rank|Adjusted for stratification factors: performance status, prior SRE, and serum alkaline phosphatase.|Zoledronic acid versus placebo group|||1.07|0.74|0.22
72421401|NCT00916032|144353906|SUPERIORITY_OR_OTHER_LEGACY|||||||0.103||95.0|||||paired t-test done on the Log(AUC 0-48h)|||||||0.103
72421402|NCT00916032|144353907|SUPERIORITY_OR_OTHER_LEGACY|||||||0.162||95.0|||||paired t-test done on the Log(AUC 0-48h)|||||||0.162
72421403|NCT03764072|144353924|SUPERIORITY|||||||0.2107||||||Dose response Model - Linear|Multiple Comparison Procedure-Modelling|||||||0.2107
72421404|NCT03764072|144353924|SUPERIORITY|||||||0.0766||||||Dose response Model - Emax|Multiple Comparison Procedure-Modelling|||||||0.0766
72421405|NCT03764072|144353924|SUPERIORITY|||||||0.0989||||||Dose response Model - Logistic|Multiple Comparison Procedure-Modelling|||||||0.0989
72421406|NCT03764072|144353924|SUPERIORITY|||||||0.0927||||||Dose-response Model - Sigmoid Emax|Multiple Comparison Procedure-Modelling|||||||0.0927
72421407|NCT03764072|144353926|SUPERIORITY|||||||0.3162|||||||Cochran-Mantel-Haenszel|||||||0.3162
72421408|NCT03764072|144353926|SUPERIORITY|||||||0.4613|||||||Cochran-Mantel-Haenszel|||||||0.4613
72421409|NCT03764072|144353926|SUPERIORITY|||||||0.4095|||||||Cochran-Mantel-Haenszel|||||||0.4095
72421410|NCT03764072|144353926|SUPERIORITY|||||||0.157|||||||Cochran-Mantel-Haenszel|||||||0.1570
72421411|NCT03764072|144353926|SUPERIORITY|||||||0.9843|||||||Cochran-Mantel-Haenszel|||||||0.9843
72421412|NCT03764072|144353927|SUPERIORITY|||||||0.8714|||||||Cochran-Mantel-Haenszel|||||||0.8714
72421413|NCT03764072|144353927|SUPERIORITY|||||||0.5815|||||||Cochran-Mantel-Haenszel|||||||0.5815
72421414|NCT03764072|144353927|SUPERIORITY|||||||0.4308|||||||Cochran-Mantel-Haenszel|||||||0.4308
72421415|NCT03764072|144353927|SUPERIORITY|||||||0.4434|||||||Cochran-Mantel-Haenszel|||||||0.4434
72421416|NCT03764072|144353927|SUPERIORITY|||||||0.855|||||||Cochran-Mantel-Haenszel|||||||0.8550
72421417|NCT03764072|144353928|SUPERIORITY|||||||0.687|||||||Cochran-Mantel-Haenszel|||||||0.6870
72421418|NCT03764072|144353928|SUPERIORITY|||||||0.1515|||||||Cochran-Mantel-Haenszel|||||||0.1515
72421419|NCT03764072|144353928|SUPERIORITY|||||||0.603|||||||Cochran-Mantel-Haenszel|||||||0.6030
72421420|NCT03764072|144353928|SUPERIORITY|||||||0.1361|||||||Cochran-Mantel-Haenszel|||||||0.1361
72421421|NCT03764072|144353928|SUPERIORITY|||||||0.564|||||||Cochran-Mantel-Haenszel|||||||0.5640
72421422|NCT03764072|144353929|SUPERIORITY||Hazard Ratio (HR)|1.26||||0.5405|TWO_SIDED|95.0|0.6|2.67|||Regression, Cox|||||2.67|0.60|0.5405
72421423|NCT03764072|144353929|SUPERIORITY||Hazard Ratio (HR)|1.05||||0.9011|TWO_SIDED|95.0|0.49|2.27|||Regression, Cox|||||2.27|0.49|0.9011
72421424|NCT03764072|144353929|SUPERIORITY||Hazard Ratio (HR)|1.04||||0.9127|TWO_SIDED|95.0|0.48|2.26|||Regression, Cox|||||2.26|0.48|0.9127
72421425|NCT03764072|144353929|SUPERIORITY||Hazard Ratio (HR)|1.24||||0.5619|TWO_SIDED|95.0|0.6|2.56|||Regression, Cox|||||2.56|0.60|0.5619
72329262|NCT03306433|144183735|EQUIVALENCE|Null hypothesis was that there were no differences between the groups|Paired difference t-test|-7.412|STANDARD_DEVIATION|6.049||0.0063|TWO_SIDED|||||Paired differrnce between UDMA-K18 and UDMA control|Paired difference test, 2 sided||There are 9 participant pairs for this comparison|Paired comparison||||0.0063
72329263|NCT03306433|144183736|EQUIVALENCE|The Null hypothesis was that there would be no differences between the groups|Chi Square on WSL Index frequency|15.77||||0.0033|TWO_SIDED||||||Chi-squared|||WSL Index is non-parametric||||0.0033
72329264|NCT03306433|144183736|EQUIVALENCE|The null hypothesis was that there would not be any differences between the groups|Chi Square on WSL Index frequency|6.8321||||0.145|TWO_SIDED||||||Chi-squared|||||||0.1450
72369789|NCT01621802|144249927|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The LL of the 2-sided 97.5% CI for the adjusted GMC ratio (Inv\_MMR\_I group divided by pooled Com\_MMR\_I group) was ≥ 0.67 for antibodies to measles, mumps and rubella viruses.|Adjusted GMC ratio|0.96|||||TWO_SIDED|97.5|0.87|1.06|||ANCOVA|Ancova model: adjustment for baseline concentration - pooled variance.|The GMCs were used to calculate the Adjusted GMCs, which in turn were used to calculate the Adjusted GMC ratio with 97.5% confidence interval.|||1.06|0.87|
72329265|NCT00803595|144183737|NON_INFERIORITY_OR_EQUIVALENCE|A noninferiority margin of 18 hours (h) was set to assure the superiority of laninamivir octanoate over a putative placebo. A meta-analysis using 3 placebo-controlled trials reported that the difference between the median time to illness alleviation in the placebo and oseltamivir groups was 33.1 h and the 95% confidence interval ranged from 19.1 to 47.1 h. From this, a margin that was less than the lower limit of this 95% CI was selected.|Median Difference (Final Values)|-0.6||||0.748|TWO_SIDED|95.0|-9.9|6.9||2-sided p-value without adjustments for multiple testing|Generalized Wilcoxon Test|||This trial was designed to confirm the efficacy of laninamivir octanoate by showing that the median time to illness alleviation in patients treated with laninamivir octanoate was not \>18 hours longer than that in patients treated with oseltamivir. Sample size of 300 patients in each group was determined to achieve a power of at least 80% to show noninferiority at both dose levels of laninamivir octanoate with use of a Monte Carlo simulation.||6.9|-9.9|0.748
72329266|NCT00803595|144183737|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-12.8||||0.038|TWO_SIDED|95.0|-18.2|-0.4||2-sided p-value without adjustments for multiple testing|Generalized Wilcoxon Test|||Null hypothesis was that there was no difference in the time to illness alleviation||-0.4|-18.2|0.038
72329267|NCT00803595|144183737|NON_INFERIORITY_OR_EQUIVALENCE|A noninferiority margin of 18 hours was set to assure the superiority of laninamivir octanoate over a putative placebo. A meta-analysis using 3 placebo-controlled trials reported that the difference between the median time to illness alleviation in the placebo and oseltamivir groups was 33.1 h and the 95% confidence interval ranged from 19.1 to 47.1 h. From this, a margin that was less than the lower limit of this 95% CI was selected.|Median Difference (Final Values)|12.2||||0.104|TWO_SIDED|95.0|-1.5|17.2|||Generalized Wilcoxon test|||This trial was designed to confirm the efficacy of laninamivir octanoate by showing that the median time to illness alleviation in patients treated with laninamivir octanoate was not \>18 hours longer than that in patients treated with oseltamivir. Sample size of 300 patients in each group was determined to achieve a power of at least 80% to show noninferiority at both dose levels of laninamivir octanoate with use of a Monte Carlo simulation.||17.2|-1.5|0.104
72329268|NCT00803595|144183738|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|3.3||||0.318|TWO_SIDED|95.0|-2.8|9.1||2-sided P value without adjustments for multiple testing.|Generalized Wilcoxon test|||Null hypothesis was that there was no difference in the time for return to normal axillary temperature.||9.1|-2.8|0.318
72329269|NCT00803595|144183738|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.6||||0.981|TWO_SIDED|95.0|-5.8|5.7||2-sided P value without adjustments for multiple testing.|Generalized Wilcoxon test|||Null hypothesis was that there was no difference in the time for return to normal axillary temperature.||5.7|-5.8|0.981
72329270|NCT00803595|144183738|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-2.7||||0.344|TWO_SIDED|95.0|-9.1|3.1||2-sided P value without adjustments for multiple testing.|Generalized Wilcoxon test|||Null hypothesis was that there was no difference in the time for return to normal axillary temperature.||3.1|-9.1|0.344
72329271|NCT00294671|144183739|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||Longitudinal analysis of the difference between placebo and diflunisal treatment groups in NIS+7 change from baseline to 2 years.||||<0.001
72329272|NCT00294671|144183739|SUPERIORITY_OR_OTHER|||||||0.02|||||||t-test, 2 sided|||Longitudinal analysis of the difference between placebo and diflunisal treatment groups in NIS+7 change from baseline to 1years.||||0.02
72329273|NCT00294671|144183740|SUPERIORITY_OR_OTHER|||||||0.002|||||||t-test, 2 sided|||Longitudinal analysis of the difference between placebo and diflunisal treatment groups in Kumamoto score change from baseline to 2 years.||||0.002
72329274|NCT00294671|144183740|SUPERIORITY_OR_OTHER|||||||0.1|||||||t-test, 2 sided|||Longitudinal analysis of the difference between placebo and diflunisal treatment groups in Kumamoto score change from baseline to 1 year.||||0.10
72329275|NCT00294671|144183741|SUPERIORITY_OR_OTHER|||||||0.21|||||||t-test, 2 sided|||Longitudinal analysis of the difference between placebo and diflunisal treatment groups in mBMI change from baseline to 2 years.||||0.21
72329276|NCT00294671|144183741|SUPERIORITY_OR_OTHER|||||||0.43|||||||t-test, 2 sided|||Longitudinal analysis of the difference between placebo and diflunisal treatment groups in mBMI change from baseline to 1 year.||||0.43
72329277|NCT00294671|144183742|SUPERIORITY_OR_OTHER|||||||0.001|||||||t-test, 2 sided|||Longitudinal analysis of the difference between placebo and diflunisal treatment groups in SF-36 physical component change from baseline to 2 years.||||0.001
72329278|NCT00294671|144183742|SUPERIORITY_OR_OTHER|||||||0.06|||||||t-test, 2 sided|||Longitudinal analysis of the difference between placebo and diflunisal treatment groups in SF-36 physical component change from baseline to 1 year.||||0.06
72329279|NCT00294671|144183743|SUPERIORITY_OR_OTHER|||||||0.06|||||||t-test, 2 sided|||Longitudinal analysis of the difference between placebo and diflunisal treatment groups in SF-36 mental component change from baseline to 2 years.||||0.06
72329280|NCT00294671|144183743|SUPERIORITY_OR_OTHER|||||||0.37|||||||t-test, 2 sided|||Longitudinal analysis of the difference between placebo and diflunisal treatment groups in SF-36 mental component change from baseline to 1 year.||||0.37
72329281|NCT02403817|144183752|OTHER|This is a small pilot study with no power calculations required (and no data upon which to base a priori power estimates).||||||5e-05|||||||t-test, 2 sided|||This analysis compares pre-intervention to post-intervention scores in the eye movement training group on the primary attention outcome measure. The hand movement Control in this pilot was not feasible and the sample is too small for analysis. This is a small pilot study and so power analyses were not computed. The null hypothesis was no difference between pre- and post-training outcome measure (alpha .05).||||0.00005
72329282|NCT02403817|144183753|OTHER|||||||0.018|||||||t-test, 2 sided|||This analysis compares pre-intervention to post-intervention scores in the eye movement training group on the primary eye movement outcome measure. The hand movement Control in this pilot was not feasible and the sample is too small for analysis. This is a small pilot study and so power analyses were not computed. The null hypothesis was no difference between pre- and post-training outcome measure (alpha .05).||||0.018
72329283|NCT02978157|144183759|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
72329284|NCT00924612|144183779|OTHER||Odds Ratio, log|130.83|STANDARD_ERROR_OF_MEAN|0.0844||0.0025|TWO_SIDED|90.0|113.59|150.7|||t-test, 2 sided|||Comparison of diets based on full crossover model|ANOVA of a multicenter, 4 sequence, 5 treatment crossover model using ln-transformed data. Normal fat diet compared to fasting, very low fat, low fat, and high fat diets as part of the overall analysis. No adjustments for multiplicity made.|150.70|113.59|0.0025
72329285|NCT00924612|144183779|OTHER||Odds Ratio, log|101.84|STANDARD_ERROR_OF_MEAN|0.0954||0.8494|TWO_SIDED|90.0|86.8|119.47|||t-test, 2 sided|||Comparison of diets based on full crossover model||119.47|86.80|0.8494
72329286|NCT00924612|144183779|OTHER||Odds Ratio, log|73.55|STANDARD_ERROR_OF_MEAN|0.0902||0.0013|TWO_SIDED|90.0|63.23|85.55|||t-test, 2 sided|||Comparison of diets based on full crossover model||85.55|63.23|0.0013
72329287|NCT00924612|144183779|OTHER||Odds Ratio, log|62.62|STANDARD_ERROR_OF_MEAN|0.0954|<|0.0001|TWO_SIDED|90.0|53.38|76.46|||t-test, 2 sided|||Comparison of diets based on full crossover model||76.46|53.38|<0.0001
72329288|NCT02229825|144183783|OTHER|||||||0.88||||||p-value for treatment effect|ANCOVA|ANCOVA with stratification factors (country and pretreatment) and baseline score and treatment as the main factor.||The null hypothesis was that the mean change in MADRS total score between week 4 and baseline was the same for the 2 duloxetine treatment groups.||||0.88
72329289|NCT02229825|144183784|OTHER|||||||0.86||||||Treatment effect.|ANCOVA|Analysis of covariance (ANCOVA) with stratification factors and HAMD6 baseline as covariates and treatment regimen as main factor.||Comparison between treatment regimes at Week 4.||||0.86
72329290|NCT02229825|144183785|OTHER||||||<|0.0001|||||||Signed Rank test|||Within-group comparisons, week 8 versus baseline.||||<0.0001
72329291|NCT02229825|144183785|OTHER||||||<|0.0001|||||||Singed Rank test|||Within-group comparison, week 8 versus baseline.||||<0.0001
72329292|NCT02229825|144183785|OTHER||||||<|0.0001|||||||Singed Rank test|||Within-group comparison, week 8 versus baseline.||||<0.0001
72329293|NCT02229825|144183785|OTHER||||||<|0.0001|||||||Signed Rank test|||Within-group comparison, week 8 versus baseline.||||<0.0001
72329294|NCT02229825|144183787|OTHER||||||<|0.0001|||||||McNemar|||Within group comparisons were performed at week 8 versus baseline.||||<0.0001
72329295|NCT02229825|144183787|OTHER||||||<|0.0001|||||||McNemar|||Within group comparisons were performed at week 8 versus baseline.||||<0.0001
72329296|NCT02229825|144183787|OTHER||||||<|0.0001|||||||McNemar|||Within group comparisons were performed at week 8 versus baseline.||||<0.0001
72329297|NCT02229825|144183787|OTHER||||||<|0.0001|||||||McNemar|||Within group comparisons were performed at week 8 versus baseline.||||<0.0001
72329298|NCT02229825|144183788|OTHER|||||||0.32||||||Treatment effect.|Regression, Logistic|||Treatment groups were compared regarding the number of responders and non-responders at week 4, using a logistic regression with stratification factors (country and pretreatment) and baseline scores as covariates and treatment regimen as main factor.||||0.32
72421426|NCT03764072|144353929|SUPERIORITY||Hazard Ratio (HR)|1.18||||0.709|TWO_SIDED|95.0|0.5|2.79|||Regression, Cox|||||2.79|0.50|0.7090
72421427|NCT03764072|144353930|SUPERIORITY||Hazard Ratio (HR)|1.28||||0.5141|TWO_SIDED|95.0|0.61|2.72|||Regression, Cox|||||2.72|0.61|0.5141
72421428|NCT03764072|144353930|SUPERIORITY||Hazard Ratio (HR)|0.98||||0.9614|TWO_SIDED|95.0|0.45|2.12|||Regression, Cox|||||2.12|0.45|0.9614
72421429|NCT03764072|144353930|SUPERIORITY||Hazard Ratio (HR)|0.99||||0.9756|TWO_SIDED|95.0|0.46|2.14|||Regression, Cox|||||2.14|0.46|0.9756
72421430|NCT03764072|144353930|SUPERIORITY||Hazard Ratio (HR)|1.24||||0.5582|TWO_SIDED|95.0|0.6|2.57|||Regression, Cox|||||2.57|0.60|0.5582
72421431|NCT03764072|144353930|SUPERIORITY||Hazard Ratio (HR)|1.15||||0.7543|TWO_SIDED|95.0|0.49|2.71|||Regression, Cox|||||2.71|0.49|0.7543
72421432|NCT00558064|144353934|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.11|STANDARD_ERROR_OF_MEAN|0.57|<|0.0001|TWO_SIDED|95.0|3.98|6.23|||Mixed Models Analysis||Difference calculated as telmisartan 40 mg plus amlodipine 5 mg fixed-dose combination minus amlodipine 5 mg monotherapy|||6.23|3.98|<0.0001
72421433|NCT03152084|144353942|OTHER|Within-group change|Least square mean|-5.21||||0.4462|TWO_SIDED|95.0|-19.542|9.12||Start of treatment vs baseline|Mixed Models Analysis|||||9.120|-19.542|0.4462
72421434|NCT03152084|144353943|OTHER|Within-group change|Least square mean|3.69||||0.7842|TWO_SIDED|95.0|-24.817|32.195||End of treatment vs baseline|Mixed Models Analysis|||||32.195|-24.817|0.7842
72329299|NCT02229825|144183790|OTHER|||||||0.57||||||Treatment effect.|Regression, Logistic|||Treatment groups were compared regarding the number of responders and non-responders at week 4, using a logistic regression with stratification factors (country and pretreatment) and baseline scores as covariates and treatment regimen as main factor.||||0.57
72329300|NCT02229825|144183793|OTHER|||||||0.68|||||||Cochran-Mantel-Haenszel|Stratified by country, 60 mg vs. 120 mg||"At week 4 CGI-S items were pooled to reduce the possible number of classes before formal testing. The 3 classes used (instead of 7 items) were: 1-2: normal, 3-5: moderate, 6-7: severe. Treatment groups were compared using the Cochran Mantel-Haenszel test with stratification by centre."||||0.68
72329301|NCT02229825|144183794|OTHER||Statistic|-528.0|||<|0.0001|||||||Signed Rank test||Difference is value at week 8 minus week 4.|At week 8, within-group comparison versus week 4 was performed.||||<0.0001
72329302|NCT02229825|144183794|OTHER||Statistic|-540.0|||<|0.0001|||||||Signed Rank test||Difference is value at week 8 minus week 4.|At week 8, within-group comparison versus week 4 was performed.||||<0.0001
72329303|NCT02229825|144183794|OTHER||Statistic|-1024.5|||<|0.0001|||||||Signed Rank test||Difference is value at week 8 minus week 4.|At week 8, within-group comparison versus week 4 was performed.||||<0.0001
72329304|NCT02229825|144183794|OTHER||Statistic|-279.0|||<|0.0001|||||||Signed Rank test||Difference is value at week 8 minus week 4.|At week 8, within-group comparison versus week 4 was performed.||||<0.0001
72329305|NCT02229825|144183795|OTHER|No formal hypothesis was tested.||||||0.07||||||Stratified by country, 60 mg vs. 120 mg|Cochran-Mantel-Haenszel|||"At week 4 CGI-S items were pooled to reduce the possible number of classes before formal testing. The 3 classes used (instead of 7 items) were: 1-2: normal, 3-5: moderate, 6-7: severe. Treatment groups were compared using the Cochran Mantel-Haenszel test with stratification by centre."||||0.07
72329306|NCT02229825|144183797|OTHER||CMH statistic|0.0||||1|||||||Cochran-Mantel-Haenszel|||"Before testing, PGI-I items were pooled to reduce the possible number of classes. The 3 classes used (instead of 7 items) were: 1-2= improved, 3-5=Stable, 6-7=Worsened. At week 4 treatment groups were compared using the Cochran Mantel-Haenszel test with stratification by centre."||||1.00
72329307|NCT02229825|144183799|OTHER|||||||0.92||||||Treatment effect|ANCOVA|||Comparison between HAMA scores between treatment regimens.||||0.92
72329308|NCT02229825|144183800|OTHER||||||<|0.0001|||||||Student statistic t-test|||Within-group comparison, week 8 versus baseline.||||<0.0001
72329309|NCT02229825|144183800|OTHER||||||<|0.0001|||||||Student statistic t-test|||Within-group comparison, week 8 versus baseline.||||<0.0001
72329310|NCT02229825|144183800|OTHER||||||<|0.0001|||||||Student statistic t-test|||Within-group comparison, week 8 versus baseline.||||<0.0001
72329311|NCT02229825|144183800|OTHER||||||<|0.0001|||||||Student statistic t-test|||Within-group comparison, week 8 versus baseline.||||<0.0001
72329312|NCT02229825|144183802|OTHER||||||<|0.0001|||||||Student statistic t-test|||Within-group comparison, Week 8 versus baseline.||||<0.0001
72329313|NCT02229825|144183802|OTHER|||||||0.001|||||||Student statistic t-test|||Within-group comparison, week 8 versus baseline.||||0.001
72329314|NCT02229825|144183802|OTHER||||||<|0.0001|||||||Student statistic t-test|||Within-group comparison, week 8 versus baseline.||||<0.0001
72329315|NCT02229825|144183802|OTHER|||||||0.28|||||||Student statistic t-test|||Within-group comparison, week 8 versus baseline.||||0.28
72329316|NCT00104416|144183809|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|31.6|||<|0.0001||95.0|15.8|48.1|||Cochran-Mantel-Haenszel|||||48.1|15.8|<0.0001
72329317|NCT01309997|144183832|SUPERIORITY_OR_OTHER|||||||0.01|||||||Wilcoxon (Mann-Whitney)|||||||0.01
72329318|NCT01309997|144183832|SUPERIORITY_OR_OTHER|||||||0.64|||||||Wilcoxon (Mann-Whitney)|||||||0.64
72329319|NCT04343534|144183833|OTHER||Mean Difference (Final Values)|0.15||||0.092|TWO_SIDED|95.0|-0.02|0.33|||t-test, 2 sided|||"SDM Process score distributions were compared to determine of the scores spanned the range of possible values, were normally distributed, had low rates of missing data, and whether there was indications of floor or ceiling effects.~we conducted independent t-tests to determine if there were differences in SDM Process scores between the two versions."||0.33|-0.02|0.092
72329320|NCT03462641|144183842|SUPERIORITY||t-value|-2.15|STANDARD_DEVIATION|1.32||0.0407|TWO_SIDED|||||Alpha was set to 0.05.|Paired-Sample Two-Tailed T-Test|||Null hypothesis was no difference in PIGD score within participants before and after flumazenil infusion.||||0.0407
72421435|NCT03152084|144353943|OTHER|Within-group change|Least square mean|-16.72||||0.0581|TWO_SIDED|95.0|-34.109|0.664||Follow-up vs End of treatment|Regression, Linear|||||0.664|-34.109|0.0581
72421436|NCT03152084|144353944|OTHER|Within-group change|Least square mean|344.85|||<|0.0001|TWO_SIDED|95.0|272.785|416.905||Start of treatment vs baseline|Mixed Models Analysis|||||416.905|272.785|<0.0001
72421437|NCT03152084|144353945|OTHER|Within-group change|Least square mean|311.3|||<|0.0001|TWO_SIDED|95.0|224.528|398.064||End of treatment vs baseline|Mixed Models Analysis|||||398.064|224.528|<0.0001
72421438|NCT03152084|144353946|OTHER|Within-group change|Least square mean|-203.07|||<|0.0001|TWO_SIDED|95.0|-235.983|-170.162||Follow-up vs end of treatment|Regression, Linear|||||-170.162|-235.983|<0.0001
72421439|NCT03152084|144353947|OTHER|Within-group change|Least square mean|-5.2658||||0.0047|TWO_SIDED|95.0|-8.5459|-1.9856||Start of treatment vs baseline|Mixed Models Analysis|||||-1.9856|-8.5459|0.0047
72421440|NCT03152084|144353948|OTHER|Within-group change|Least square mean|-7.0987||||0.0003|TWO_SIDED|95.0|-10.0379|-4.1595||End of treatment vs baseline|Mixed Models Analysis|||||-4.1595|-10.0379|0.0003
72421441|NCT03152084|144353949|OTHER|Within-group change|Least square mean|0.7287||||0.5592|TWO_SIDED|95.0|-1.9894|3.4468||Follow-up vs end of treatment|Regression, Linear|||||3.4468|-1.9894|0.5592
72421442|NCT03152084|144353950|OTHER|Within-group change|Least square mean|0.0315||||0.9288|TWO_SIDED|95.0|-0.7274|0.7904||Start of treatment vs baseline|Mixed Models Analysis|||||0.7904|-0.7274|0.9288
72421443|NCT03152084|144353951|OTHER|Within-group change|Least square mean|-0.4318||||0.1659|TWO_SIDED|95.0|-1.0761|0.2125||End of treatment vs baseline|Mixed Models Analysis|||||0.2125|-1.0761|0.1659
72421444|NCT03152084|144353952|OTHER|Within-group change|Least square mean|0.4755||||0.019|TWO_SIDED|95.0|0.0963|0.8548||Follow-up vs end of treatment|Regression, Linear|||||0.8548|0.0963|0.0190
72421445|NCT03152084|144353953|OTHER|Within-group change|Least square mean|-0.6713||||0.0157|TWO_SIDED|95.0|-1.1914|-0.1511||Start of treatment vs baseline|Mixed Models Analysis|||||-0.1511|-1.1914|0.0157
72421446|NCT03152084|144353954|OTHER|Within-group change|Least square mean|-0.0324||||0.87|TWO_SIDED|95.0|-0.4631|0.3984||End of treatment vs baseline|Mixed Models Analysis|||||0.3984|-0.4631|0.8700
72421447|NCT03152084|144353955|OTHER|Within-group change|Least square mean|0.1718||||0.2446|TWO_SIDED|95.0|-0.1358|0.4795||Follow-up vs end of treatment|Regression, Linear|||||0.4795|-0.1358|0.2446
72421448|NCT03152084|144353956|OTHER|Within-group change|Least square mean|-2.1||||0.0023|TWO_SIDED|95.0|-3.299|-0.902||Start of treatment vs baseline|Mixed Models Analysis|||||-0.902|-3.299|0.0023
72421449|NCT03152084|144353956|OTHER|Within-group change|Least square mean|-1.59|||<|0.0001|TWO_SIDED|95.0|-1.929|-1.256||End of treatment vs baseline|Mixed Models Analysis|||||-1.256|-1.929|<0.0001
72421450|NCT03152084|144353956|OTHER|Within-group change|Least square mean|3.88||||0.0002|TWO_SIDED|95.0|2.215|5.553||Follow-up vs end of treatment|Regression, Linear|||||5.553|2.215|0.0002
72421451|NCT03881696|144354025|SUPERIORITY||Odds Ratio (OR)|27.853|||<|1e-05|TWO_SIDED|95.0|9.1274|111.2144||The a priori threshold for statistical significance was p \< 0.0001 at the interim analysis OR p \< 0.05 at the final analysis. Gatekeeping and multiple testing strategies were performed to ensure the overall family-wise error rate was ≤ 5%.|Fisher Exact||The odds ratio (OR) represents the odds of success among subjects randomized to omalizumab (numerator) compared to the odds of success among subjects randomized to placebo (denominator, reference group).|The null hypothesis is that the odds of 'success' (defined as consumption of a single dose of ≥600 mg of peanut protein without dose-limiting symptoms during the DBPCFC at the end of Stage 1) in omalizumab and placebo for omalizumab arms are equal. Participants missing the blinded OFC to peanut at the end of Stage 1 will be considered a 'failure' for the primary efficacy endpoint.||111.2144|9.1274|<0.00001
72421452|NCT01392300|144354136|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.7|-0.3|||ANCOVA|||||-0.3|-0.7|<0.001
72421453|NCT01392300|144354137|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3|STANDARD_ERROR_OF_MEAN|0.11||0.003|TWO_SIDED|95.0|0.1|0.5|||ANCOVA|||||0.5|0.1|0.003
72421454|NCT01392300|144354138|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.28|||<|0.001|TWO_SIDED|95.0|2.43|7.52|||Regression, Logistic|||||7.52|2.43|<0.001
72421455|NCT01392300|144354139|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.69|||<|0.001|TWO_SIDED|95.0|1.56|4.63|||Regression, Logistic|||||4.63|1.56|<0.001
72421456|NCT01392300|144354140|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.48||||0.004|TWO_SIDED|95.0|1.33|4.61|||Regression, Logistic|||||4.61|1.33|0.004
72421457|NCT01392300|144354141|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.13|||<|0.001|TWO_SIDED|95.0|1.76|5.57|||Regression, Logistic|||||5.57|1.76|<0.001
72421458|NCT01392300|144354142|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.92||||0.021|TWO_SIDED|95.0|1.1|3.34|||Regression, Logistic|||||3.34|1.10|0.021
72421459|NCT01392300|144354143|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.58||||0.006|TWO_SIDED|95.0|1.32|5.05|||Regression, Logistic|||||5.05|1.32|0.006
72421460|NCT01392300|144354144|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.72|||<|0.001|TWO_SIDED|95.0|2.06|6.72|||Regression, Logistic|||||6.72|2.06|<0.001
72421461|NCT01392300|144354145|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.5||||0.002|TWO_SIDED|95.0|1.4|4.46|||Regression, Logistic|||||4.46|1.40|0.002
72329321|NCT03462641|144183842|OTHER||F-value|2.861||||0.103|TWO_SIDED|||||"P value is given for the Drug\*Time term, which represents interaction between time relative to administration (before infusion vs after infusion) and treatment administered (placebo vs flumazenil).~Alpha was set to 0.05."|Repeated Measures ANCOVA|||Null hypothesis is that there is no significant interaction between drug and time of administration (pre vs. post infusion).||||0.103
72329322|NCT03462641|144183843|OTHER||Standardized β Coefficient|0.6||||2.9e-07|TWO_SIDED|95.0|0.13|1.07||P value presented is for model comparison between interaction model and random intercept model.|Mixed Models Analysis|||A pair of maximum likelihood mixed linear models were estimated. The first was a random intercept model that merely accounted for individual differences in PIGD score before infusion. The second was an interaction model, that added an interaction term between baseline FMZ PET binding and PIGD score change from pre to post infusion. The interaction model was compared against the random intercept model to determine significance of the interaction using likelihood ratio goodness of fit test.||1.07|0.13|0.00000029
72329323|NCT00066222|144183856|OTHER|||||||||||||||||This study was designed to detect an improvement in the 2-year overall survival rate from 47% to 60%. Using a one-group chi-square test with a one-sided significance level of 0.10, a sample of 67 patients was deemed sufficient to detect the difference between the null hypothesis (H0: P .47) and the alternative hypothesis (HA: P .60) with 80% power.|If the point estimate for two-year survival is less than or equal to 0.54815, the upper bound of the one-sided 90% confidence interval on 47%, then H0 would not be rejected and the conclusion would be that the two-year survival rate did not statistically improve from 47% under the new treatment. If the point estimate is greater than 0.54815, then H0 would be rejected and the conclusion is that the two-year survival rate did improve from 47% to 60% under the new treatment.|||
72329324|NCT00066222|144183859|OTHER||||||||||||||||||The following rule would reject the null hypothesis that the proportion of severe esophagitis was 30% with an overall significance level of 0.05: 27 or more cases of severe esophagitis among the total sample of evaluable patients.|||
72329325|NCT00066222|144183860|OTHER||||||||||||||||||The following rule would reject the null hypothesis that the proportion of treatment-related fatalities was less than or equal to 5% with an overall significance level of 0.05: 6 or more instances of treatment-related fatalities among the total sample of evaluable patients.|||
72421462|NCT01392300|144354146|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.7||||0.102|TWO_SIDED|95.0|0.9|3.22|||Regression, Logistic|||||3.22|0.90|0.102
72329326|NCT02767869|144183870|SUPERIORITY_OR_OTHER_LEGACY|||||||0.021|||||||Wilcoxon (Mann-Whitney)|||||||0.021
72329327|NCT02767869|144183871|SUPERIORITY_OR_OTHER_LEGACY|||||||0.53|||||||Wilcoxon (Mann-Whitney)|||||||0.530
72329328|NCT02767869|144183872|SUPERIORITY_OR_OTHER_LEGACY|||||||0.034|||||||Wilcoxon (Mann-Whitney)|||||||0.034
72329329|NCT02767869|144183873|SUPERIORITY_OR_OTHER_LEGACY|||||||0.05|||||||Wilcoxon (Mann-Whitney)|||||||0.050
72329330|NCT02767869|144183874|SUPERIORITY_OR_OTHER_LEGACY|||||||0.799|||||||Wilcoxon (Mann-Whitney)|||||||0.799
72329331|NCT02767869|144183875|SUPERIORITY_OR_OTHER_LEGACY|||||||0.047|||||||Wilcoxon (Mann-Whitney)|||||||0.047
72329332|NCT02767869|144183876|SUPERIORITY_OR_OTHER_LEGACY|||||||0.878|||||||Wilcoxon (Mann-Whitney)|||||||0.878
72329333|NCT02767869|144183877|SUPERIORITY_OR_OTHER_LEGACY|||||||0.919|||||||Wilcoxon (Mann-Whitney)|||||||0.919
72329334|NCT02767869|144183878|SUPERIORITY_OR_OTHER_LEGACY|||||||0.254|||||||Wilcoxon (Mann-Whitney)|||||||0.254
72329335|NCT02767869|144183879|SUPERIORITY_OR_OTHER_LEGACY|||||||0.347|||||||Wilcoxon (Mann-Whitney)|||||||0.347
72329336|NCT02767869|144183880|SUPERIORITY_OR_OTHER_LEGACY|||||||0.227|||||||Wilcoxon (Mann-Whitney)|||||||0.227
72329337|NCT02767869|144183881|SUPERIORITY_OR_OTHER_LEGACY|||||||0.41|||||||Wilcoxon (Mann-Whitney)|||||||0.410
72329338|NCT02767869|144183882|SUPERIORITY_OR_OTHER_LEGACY|||||||0.021|||||||Wilcoxon (Mann-Whitney)|||||||0.021
72329339|NCT04301934|144183883|NON_INFERIORITY|The prevalence of UTI for the LASER group and vaginal estrogen group was calculated. Non-inferiority test using Farrington-Manning method was applied to test the risk difference against the pre-specified non-inferiority margin (20%).||||||0.034|||||||Farrington-Manning|||||||0.034
72329340|NCT00394329|144183956|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.56|STANDARD_ERROR_OF_MEAN|0.28||0.066|TWO_SIDED|95.0|0.32|0.96||Hochberg adjustment was applied to the p-value to account for each of three active group comparisons to the placebo group. The unadjusted p-value is 0.033.|Regression, Cox|||||0.96|0.32|0.066
72421463|NCT01392300|144354147|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.95|||<|0.001|TWO_SIDED|95.0|1.67|5.23|||Regression, Logistic|||||5.23|1.67|<0.001
72329341|NCT02091362|144183970|SUPERIORITY_OR_OTHER||LS Mean Difference|2.26|||<|0.001|TWO_SIDED|95.0|1.11|3.4|||Mixed Models Analysis|||||3.40|1.11|<.001
72329342|NCT02091362|144183971|SUPERIORITY_OR_OTHER||LS Mean Difference|1.37|||<|0.01|TWO_SIDED|95.0|0.66|2.08|||Mixed Models Analysis|||||2.08|0.66|<0.01
72329343|NCT00617097|144183988|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5||||0.94|TWO_SIDED|95.0|-13.7|12.6|||Regression, Linear|||expected level of pain during procedure greater number is worse (i.e., more pain) 100-mm Visual Analogue Scale (VAS): minimum: 0 mm (less pain); maximum: 100 mm (more pain)||12.6|-13.7|0.94
72329344|NCT00617097|144183988|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9||||0.9|TWO_SIDED|95.0|-15.1|13.2|||Regression, Linear|||after speculum insertion greater number is worse (i.e., more pain) 100-mm Visual Analogue Scale (VAS): minimum: 0 mm (less pain); maximum: 100 mm (more pain)||13.2|-15.1|0.9
72329345|NCT00617097|144183988|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.8||||0.49|TWO_SIDED|95.0|-18.6|9.0|||Regression, Linear|||during paracervical block administration greater number is worse (i.e., more pain) 100-mm Visual Analogue Scale (VAS): minimum: 0 mm (less pain); maximum: 100 mm (more pain)||9|-18.6|0.49
72329346|NCT00617097|144183988|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.0||||0.03|TWO_SIDED|95.0|-28.3|-1.7|||Regression, Linear|||after cervical dilation greater number is worse (i.e., more pain) 100-mm Visual Analogue Scale (VAS): minimum: 0 mm (less pain); maximum: 100 mm (more pain)||-1.7|-28.3|0.03
72329347|NCT00617097|144183988|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.7||||0.7|TWO_SIDED|95.0|-12.2|18.0|||Regression, Linear|||immediately after procedure greater number is worse (i.e., more pain) 100-mm Visual Analogue Scale (VAS): minimum: 0 mm (less pain); maximum: 100 mm (more pain)||18|-12.2|0.7
72329348|NCT00617097|144183988|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.1||||0.52|TWO_SIDED|95.0|-17.0|8.8|||Regression, Linear|||30 min after procedure greater number is worse (i.e., more pain) 100-mm Visual Analogue Scale (VAS): minimum: 0 mm (less pain); maximum: 100 mm (more pain)||8.8|-17|.52
72329349|NCT00617097|144183989|SUPERIORITY_OR_OTHER|||||||0.93|||||||Regression, Linear|||greater number is better (i.e., more satisfaction) 100-mm Visual Analogue Scale (VAS): minimum: 0 mm (less satisfaction); maximum: 100 mm (greater satisfaction) Measured at end of study (i.e., upon clinic discharge)||||0.93
72329350|NCT00617097|144183990|SUPERIORITY_OR_OTHER|||||||0.07|||||||Chi-squared|||greater number is worse (i.e., more symptoms)||||0.07
72329351|NCT00617097|144183991|SUPERIORITY_OR_OTHER|||||||1|||||||Chi-squared|||minor complications greater number is worse (i.e., more complications)||||1
72329352|NCT00617097|144183991|SUPERIORITY_OR_OTHER|||||||0.15|||||||Chi-squared|||serious complications||||0.15
72329353|NCT05319899|144183992|OTHER||Geometric Mean Ratio (%)|140.63|||||TWO_SIDED|90.0|118.94|166.26||||||Analysis was performed using analysis of variance (ANOVA).||166.26|118.94|
72329354|NCT05319899|144183992|OTHER||Geometric Mean Ratio (%)|77.65|||||TWO_SIDED|90.0|65.67|91.8||||||Analysis was performed using ANOVA.||91.80|65.67|
72329355|NCT05319899|144183993|OTHER||Geometric Mean Ratio (%)|128.23|||||TWO_SIDED|90.0|112.99|145.52||||||Analysis was performed using ANOVA.||145.52|112.99|
72329356|NCT05319899|144183993|OTHER||Geometric Mean Ratio (%)|95.94|||||TWO_SIDED|90.0|84.54|108.88||||||Analysis was performed using ANOVA.||108.88|84.54|
72329357|NCT03583359|144184060|SUPERIORITY||Difference in Responder Rate|66.8|||<|0.0001|TWO_SIDED|95.0|53.7|75.2|||Fisher's exact test|The Fisher's exact test was utilized to test the superiority of treatment (Radiesse \[+\]) over control group.|Two-sided Newcombe confidence intervals (CIs) were calculated for difference in responder rate.|||75.2|53.7|<0.0001
72329358|NCT01831466|144184085|SUPERIORITY_OR_OTHER||Difference in response rates|3.9|STANDARD_ERROR_OF_MEAN|6.36||0.5425|TWO_SIDED|80.0|-4.3|12.0|||Cochran-Mantel-Haenszel|||||12.0|-4.3|0.5425
72329359|NCT01831466|144184085|SUPERIORITY_OR_OTHER||Difference in response rates|-4.0|STANDARD_ERROR_OF_MEAN|5.87||0.4976|TWO_SIDED|80.0|-11.5|3.5|||Cochran-Mantel-Haenszel|||||3.5|-11.5|0.4976
72329360|NCT01831466|144184085|SUPERIORITY_OR_OTHER||Difference in response rates|3.3|STANDARD_ERROR_OF_MEAN|6.36||0.6039|TWO_SIDED|80.0|-4.9|11.5|||Cochran-Mantel-Haenszel|||||11.5|-4.9|0.6039
72329361|NCT01831466|144184085|SUPERIORITY_OR_OTHER||Difference in response rate|4.0|STANDARD_ERROR_OF_MEAN|6.34||0.5279|TWO_SIDED|80.0|-4.1|12.1|||Cochran-Mantel-Haenszel|||||12.1|-4.1|0.5279
72329362|NCT01831466|144184086|SUPERIORITY_OR_OTHER||Difference in response rates|10.8|STANDARD_ERROR_OF_MEAN|5.99||0.071|TWO_SIDED|80.0|3.1|18.5|||Cochran-Mantel-Haenszel|||||18.5|3.1|0.0710
72329363|NCT01831466|144184086|SUPERIORITY_OR_OTHER||Difference in response rates|-1.2|STANDARD_ERROR_OF_MEAN|5.2||0.8175|TWO_SIDED|80.0|-7.9|5.5|||Cochran-Mantel-Haenszel|||||5.5|-7.9|0.8175
72329364|NCT01831466|144184086|SUPERIORITY_OR_OTHER||Difference in response rates|11.0|STANDARD_ERROR_OF_MEAN|5.63||0.0513|TWO_SIDED|80.0|3.8|18.2|||Cochran-Mantel-Haenszel|||||18.2|3.8|0.0513
72329365|NCT01831466|144184086|SUPERIORITY_OR_OTHER||Difference in response rates|6.7|STANDARD_ERROR_OF_MEAN|5.23||0.2021|TWO_SIDED|80.0|0.0|13.4|||Cochran-Mantel-Haenszel|||||13.4|-0.0|0.2021
72329366|NCT00349349|144184141|SUPERIORITY_OR_OTHER||percentage of responders|0.49|||<|0.0001|TWO_SIDED|95.3|0.39|0.6||The p value is testing the hypothesis that the response rate is equal to 15% versus the response rate is not equal to 15%.|Two-sided exact binomial test||Two-sided 95.3% exact confidence intervals were calculated based on the binomial distribution.|||0.60|0.39|<0.0001
72329367|NCT00349349|144184141|SUPERIORITY_OR_OTHER||percentage of responders|0.43|||<|0.0001|TWO_SIDED|95.3|0.33|0.53||The p value is testing the hypothesis that the response rate is equal to 15% versus the response rate is not equal to 15%.|Two-sided exact binomial test||Two sided 95.3% exact confidence intervals were calculated based on the binomial distribution.|||0.53|0.33|<0.0001
72329368|NCT00349349|144184141|SUPERIORITY_OR_OTHER||percentage of responders|0.63|||<|0.001|TWO_SIDED|95.3|0.35|0.85||The p value is testing the hypothesis that the response rate is equal to 15% versus the response rate is not equal to 15%.|Two-sided exact binomial test||Two-sided 95.3% exact confidence intervals were calculated based on the binomial distribution.|||0.85|0.35|<0.001
72329369|NCT04776720|144184188|SUPERIORITY||Model based LS mean difference|0.19||||0.743|TWO_SIDED|95.0|-0.95|1.34|||Mixed Models Analysis|adjusted for baseline value Repeated measures mixed models, unstructured variance co-variance matrix||||1.34|-0.95|0.743
72329370|NCT04776720|144184189|SUPERIORITY||Model based LS mean difference|0.98||||0.043|TWO_SIDED|95.0|0.03|1.93|||Mixed Models Analysis|adjusted for baseline value Repeated measures mixed models, unstructured variance co-variance matrix||||1.93|0.03|0.043
72329371|NCT04776720|144184190|SUPERIORITY||Model based LS mean difference|0.99||||0.689|TWO_SIDED|95.0|-3.87|5.84|||Mixed Models Analysis|adjusted for baseline value Repeated measures mixed models, with variance co-variance matrix||||5.84|-3.87|0.689
72329372|NCT04776720|144184191|SUPERIORITY||Model based LS mean difference|-0.28||||0.685|TWO_SIDED|95.0|-1.63|1.07|||Mixed Models Analysis|adjusted for baseline value Repeated measures mixed models, unstructured variance co-variance matrix||||1.07|-1.63|0.685
72329373|NCT04776720|144184192|SUPERIORITY||Model based LS mean difference|0.3||||0.764|TWO_SIDED|95.0|-1.69|2.3|||Mixed Models Analysis|adjusted for baseline value Repeated measures mixed models, unstructured variance co-variance matrix||||2.3|-1.69|0.764
72329374|NCT04776720|144184193|SUPERIORITY||Model based LS mean difference|-0.12||||0.883|TWO_SIDED|95.0|-1.78|1.53|||Mixed Models Analysis|adjusted for baseline value Repeated measures mixed models, unstructured variance co-variance matrix||||1.53|-1.78|0.883
72329375|NCT04776720|144184194|SUPERIORITY||Model based LS mean difference|-0.11||||0.753|TWO_SIDED|95.0|-0.83|0.6|||Mixed Models Analysis|adjusted for baseline value Repeated measures mixed models, unstructured variance co-variance matrix||||0.6|-0.83|0.753
72329376|NCT04776720|144184195|SUPERIORITY||Model based LS mean difference|-3.4||||0.276|TWO_SIDED|95.0|-9.54|2.74|||Mixed Models Analysis|Adjusted for baseline value Repeated measures mixed models, unstructured variance co-variance matrix||||2.74|-9.54|0.276
72329377|NCT04776720|144184196|SUPERIORITY||Model based LS mean difference|-0.29||||0.319|TWO_SIDED|95.0|-0.86|0.28|||Mixed Models Analysis|adjusted for baseline value Repeated measures mixed models, unstructured variance co-variance matrix||||0.28|-0.86|0.319
72329378|NCT04776720|144184197|SUPERIORITY||Model based LS mean difference|0.1||||0.448|TWO_SIDED|95.0|-0.15|0.34|||Mixed Models Analysis|adjusted for baseline value Repeated measures mixed models, unstructured variance co-variance matrix||||0.34|-0.15|0.448
72329379|NCT00851890|144184235|SUPERIORITY_OR_OTHER|||||||0.012|TWO_SIDED|||||No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.|ANCOVA|The treatment group was the factor and log10 baseline HCV RNA level was the covariate.||Eight participants per ABT-333 group and 12 participants in the placebo group provided \>95% power to detect a 1.4 log10 difference with a common standard deviation of 0.7 log10 using a two-sided, non-paired t-test with a significance level of 0.05.||||0.012
72329380|NCT00851890|144184235|SUPERIORITY_OR_OTHER|||||||0.071|TWO_SIDED|||||No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.|ANCOVA|The treatment group was the factor and log10 baseline HCV RNA level was the covariate.||Eight participants per ABT-333 group and 12 participants in the placebo group provided \>95% power to detect a 1.4 log10 difference with a common standard deviation of 0.7 log10 using a two-sided, non-paired t-test with a significance level of 0.05.||||0.071
72329381|NCT00851890|144184235|SUPERIORITY_OR_OTHER|||||||0.14|TWO_SIDED|||||No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.|ANCOVA|The treatment group was the factor and log10 baseline HCV RNA level was the covariate.||Eight participants per ABT-333 group and 12 participants in the placebo group provided \>95% power to detect a 1.4 log10 difference with a common standard deviation of 0.7 log10 using a two-sided, non-paired t-test with a significance level of 0.05.||||0.140
72421464|NCT01392300|144354148|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.46||||0.002|TWO_SIDED|95.0|1.37|4.41|||Regression, Logistic|||||4.41|1.37|0.002
72421465|NCT01392300|144354149|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.87||||0.069|TWO_SIDED|95.0|0.95|3.69|||Regression, Logistic|||||3.69|0.95|0.069
72329382|NCT00851890|144184236|SUPERIORITY_OR_OTHER|||||||0.008|TWO_SIDED|||||No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.|ANCOVA|The treatment group was the factor and log10 baseline HCV RNA level was the covariate.||Eight participants per ABT-333 group and 12 participants in the placebo group provided \>95% power to detect a 1.4 log10 difference with a common standard deviation of 0.7 log10 using a two-sided, non-paired t-test with a significance level of 0.05.||||0.008
72329383|NCT00851890|144184236|SUPERIORITY_OR_OTHER|||||||0.003|TWO_SIDED|||||No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.|ANCOVA|The treatment group was the factor and log10 baseline HCV RNA level was the covariate.||Eight participants per ABT-333 group and 12 participants in the placebo group provided \>95% power to detect a 1.4 log10 difference with a common standard deviation of 0.7 log10 using a two-sided, non-paired t-test with a significance level of 0.05.||||0.003
72329384|NCT00851890|144184236|SUPERIORITY_OR_OTHER|||||||0.009|TWO_SIDED|||||No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.|ANCOVA|The treatment group was the factor and log10 baseline HCV RNA level was the covariate.||Eight participants per ABT-333 group and 12 participants in the placebo group provided \>95% power to detect a 1.4 log10 difference with a common standard deviation of 0.7 log10 using a two-sided, non-paired t-test with a significance level of 0.05.||||0.009
72329385|NCT00851890|144184243|SUPERIORITY_OR_OTHER|||||||0.018|TWO_SIDED|||||No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.|ANCOVA|The treatment group was the factor and log10 baseline HCV RNA level was the covariate.||The statistical analysis represents the Day 28 time point.||||0.018
72329386|NCT00851890|144184243|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED|||||No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.|ANCOVA|The treatment group was the factor and log10 baseline HCV RNA level was the covariate.||The statistical analysis represents the Day 28 time point.||||0.020
72329387|NCT00851890|144184243|SUPERIORITY_OR_OTHER|||||||0.054|TWO_SIDED|||||No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.|ANCOVA|The treatment group was the factor and log10 baseline HCV RNA level was the covariate.||The statistical analysis represents the Day 28 time point.||||0.054
72329388|NCT00851890|144184243|SUPERIORITY_OR_OTHER|||||||0.01|TWO_SIDED|||||No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.|ANCOVA|The treatment group was the factor and log10 baseline HCV RNA level was the covariate.||The statistical analysis represents the Final Visit time point.||||0.010
72329389|NCT00851890|144184243|SUPERIORITY_OR_OTHER|||||||0.005|TWO_SIDED|||||No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.|ANCOVA|The treatment group was the factor and log10 baseline HCV RNA level was the covariate.||The statistical analysis represents the Final Visit time point.||||0.005
72329390|NCT00851890|144184243|SUPERIORITY_OR_OTHER|||||||0.014|TWO_SIDED|||||No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.|ANCOVA|The treatment group was the factor and log10 baseline HCV RNA level was the covariate.||The statistical analysis represents the Final Visit time point.||||0.014
72329391|NCT00851890|144184244|SUPERIORITY_OR_OTHER|||||||0.026|TWO_SIDED|||||No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.|Fisher Exact|||||||0.026
72329392|NCT00851890|144184244|SUPERIORITY_OR_OTHER|||||||0.026|TWO_SIDED|||||No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.|Fisher Exact|||||||0.026
72329393|NCT00851890|144184244|SUPERIORITY_OR_OTHER|||||||0.138|TWO_SIDED|||||No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.|Fisher Exact|||||||0.138
72329394|NCT00851890|144184245|SUPERIORITY_OR_OTHER|||||||0.209|TWO_SIDED|||||No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.|Fisher Exact|||||||0.209
72329395|NCT00851890|144184245|SUPERIORITY_OR_OTHER|||||||0.473|TWO_SIDED|||||No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.|Fisher Exact|||||||0.473
72329396|NCT00851890|144184245|SUPERIORITY_OR_OTHER|||||||0.031|TWO_SIDED|||||No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.|Fisher Exact|||||||0.031
72329397|NCT00851890|144184246|SUPERIORITY_OR_OTHER|||||||0.209|TWO_SIDED|||||No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.|Fisher Exact|||||||0.209
72329398|NCT00851890|144184246|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED|||||No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.|Fisher Exact|||||||1.000
72421466|NCT01392300|144354150|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.05||||0.034|TWO_SIDED|95.0|1.05|4.0|||Regression, Logistic|||||4.00|1.05|0.034
72421467|NCT01392300|144354151|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.61||||0.169|TWO_SIDED|95.0|0.82|3.16|||Regression, Logistic|||||3.16|0.82|0.169
72421468|NCT01392300|144354152|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.04||||0.92|TWO_SIDED|95.0|0.49|2.18|||Regression, Logistic|||||2.18|0.49|0.920
72329399|NCT03135431|144184249|NON_INFERIORITY|\<=.5g/dl difference in the decrease in hemoglobin was considered equivalent as 1 unit of blood typically raises the hemoglobin by 1g/dl and would be a clinical significant difference.|Mean Difference (Final Values)|-0.04121||||0.08|ONE_SIDED|95.0||0.0712|||t-test, 1 sided|||Assuming that a difference of 0.5 g/dl in the drop in hemoglobin between study arms would be considered as equivalent, and assuming a common standard deviation of 1.1 based on previous studies of cesarean deliveries deliveries , the study would have 80% power to test for non-inferiority with 60 participants in each arm (120 total).|Based on new data from a retrospective study preformed at Mayo Clinic sites an additional power calculation was preformed. Based on the new information, our study was well powered (84%) to assess our primary aim with 38 participants (18 salpingectomy, 20 BTL); therefore, we discontinued recruitment and completed the study with the accrued subjects.|.0712||0.08
72329400|NCT03135431|144184250|SUPERIORITY||Mean Difference (Final Values)|-11.21|||||TWO_SIDED|95.0|-14.1|-8.3|||||Evidence to suggest salpingecotomy procedure had a longer operation time than a tubal ligation.|||-8.3|-14.1|
72329401|NCT03135431|144184251|SUPERIORITY||Mean Difference (Net)|-9.17||||0.77|TWO_SIDED|95.0|-72.5|54.17|||t-test, 2 sided|||Analysis preformed as categorical and categorical variable. Both analyzes had the same conclusion.||54.17|-72.5|0.77
72329402|NCT03122145|144184254|SUPERIORITY|Mann whitney U between groups comparison for voluntary cough parameters between healthy controls and individuals with ALS outcomes: peak expiratory cough flow and cough volume acceleration||||||0.0005|||||||ANOVA|||Hypothesis that voluntary cough \> reflex cough strength and effectiveness in healthy volunteers||||0.0005
72329403|NCT01597908|144184256|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.7|||||TWO_SIDED|95.0|0.58|0.83|||||Hazard ratios are estimated using a Pike estimator.|||0.83|0.58|
72329404|NCT01597908|144184257|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.62|||||TWO_SIDED|95.0|0.52|0.73|||||Hazard ratios are estimated using a Pike estimator.|||0.73|0.52|
72329405|NCT01597908|144184259|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.64|||||TWO_SIDED|95.0|0.51|0.81||||||||0.81|0.51|
72329406|NCT04114071|144184266|EQUIVALENCE|An independent sample t tests was used to examine the difference score for each of the four outcome measures of interest (steps, WC, weight, and HbA1c) between intervention and control groups.|||||<|0.05|||||||t-test, 2 sided|||||||<0.05
72421469|NCT01392300|144354153|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.56|||<|0.001|TWO_SIDED|95.0|1.83|6.91|||Regression, Logistic|||||6.91|1.83|<0.001
72421470|NCT01392300|144354154|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.41||||0.007|TWO_SIDED|95.0|1.28|4.56|||Regression, Logistic|||||4.56|1.28|0.007
72421471|NCT01392300|144354155|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.26||||0.018|TWO_SIDED|95.0|1.15|4.41|||Regression, Logistic|||||4.41|1.15|0.018
72421472|NCT01392300|144354156|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|||<|0.001|TWO_SIDED|95.0|-0.5|-0.2|||ANCOVA|||||-0.2|-0.5|<0.001
72421473|NCT01392300|144354157|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.09||0.011|TWO_SIDED|95.0|-0.4|-0.1|||ANCOVA|||||-0.1|-0.4|0.011
72421474|NCT01392300|144354158|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.08||0.032|TWO_SIDED|95.0|-0.3|0.0|||ANCOVA|||||0.0|-0.3|0.032
72421475|NCT01392300|144354159|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-0.6|-0.2|||ANCOVA|||||-0.2|-0.6|<0.001
72421476|NCT01392300|144354160|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.09|<|0.001|TWO_SIDED|95.0|-0.5|-0.1|||ANCOVA|||||-0.1|-0.5|<0.001
72421477|NCT01392300|144354161|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.08||0.029|TWO_SIDED|95.0|-0.3|0.0|||ANCOVA|||||0.0|-0.3|0.029
72421478|NCT01392300|144354162|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.09|<|0.001|TWO_SIDED|95.0|-0.5|-0.2|||ANCOVA|||||-0.2|-0.5|<0.001
72421479|NCT01392300|144354163|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.09||0.019|TWO_SIDED|95.0|-0.4|0.0|||ANCOVA|||||0.0|-0.4|0.019
72421480|NCT01392300|144354164|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.08||0.137|TWO_SIDED|95.0|-0.3|0.0|||ANCOVA|||||0.0|-0.3|0.137
72421481|NCT01392300|144354165|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.09||0.013|TWO_SIDED|95.0|-0.4|0.0|||ANCOVA|||||0.0|-0.4|0.013
72421482|NCT01392300|144354166|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.09||0.131|TWO_SIDED|95.0|-0.3|0.0|||ANCOVA|||||0.0|-0.3|0.131
72421483|NCT01392300|144354167|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.08||0.714|TWO_SIDED|95.0|-0.2|0.1|||ANCOVA|||||0.1|-0.2|0.714
72421484|NCT01392300|144354168|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-0.5|-0.2|||ANCOVA|||||-0.2|-0.5|<0.001
72421485|NCT01392300|144354169|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.09||0.008|TWO_SIDED|95.0|-0.4|-0.1|||ANCOVA|||||-0.1|-0.4|0.008
72421486|NCT01392300|144354170|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.08||0.062|TWO_SIDED|95.0|-0.3|0.0|||ANCOVA|||||0.0|-0.3|0.062
72421487|NCT01392300|144354171|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.08||0.006|TWO_SIDED|95.0|-0.4|-0.1|||ANCOVA|||||-0.1|-0.4|0.006
72421488|NCT01392300|144354172|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.08||0.076|TWO_SIDED|95.0|-0.3|0.0|||ANCOVA|||||0.0|-0.3|0.076
72421489|NCT01392300|144354173|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.08||0.416|TWO_SIDED|95.0|-0.2|0.1|||ANCOVA|||||0.1|-0.2|0.416
72421490|NCT01392300|144354174|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|95.0|-0.4|-0.1|||ANCOVA|||||-0.1|-0.4|<0.001
72421491|NCT01392300|144354175|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.08||0.175|TWO_SIDED|95.0|-0.3|0.1|||ANCOVA|||||0.1|-0.3|0.175
72421492|NCT01392300|144354176|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.08||0.14|TWO_SIDED|95.0|-0.3|0.0|||ANCOVA|||||0.0|-0.3|0.140
72421493|NCT01392300|144354177|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.07||0.007|TWO_SIDED|95.0|-0.4|-0.1|||ANCOVA|||||-0.1|-0.4|0.007
72421494|NCT01392300|144354178|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.08||0.018|TWO_SIDED|95.0|-0.3|0.0|||ANCOVA|||||0.0|-0.3|0.018
72421495|NCT01392300|144354179|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.07||0.105|TWO_SIDED|95.0|-0.3|0.0|||ANCOVA|||||0.0|-0.3|0.105
72421496|NCT01392300|144354180|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.08||0.016|TWO_SIDED|95.0|-0.4|0.0|||ANCOVA|||||0.0|-0.4|0.016
72421497|NCT01392300|144354181|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.08||0.014|TWO_SIDED|95.0|-0.4|0.0|||ANCOVA|||||0.0|-0.4|0.014
72421498|NCT01392300|144354182|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.07||0.22|TWO_SIDED|95.0|-0.2|0.1|||ANCOVA|||||0.1|-0.2|0.220
72329407|NCT01659996|144184267|NON_INFERIORITY_OR_EQUIVALENCE|If the upper limit of the two-sided 95% confidence interval (CI) of the difference between the two proportions was \< δ for serogroup A and assuming the difference between the two proportions was normally distributed, the inferiority assumption was to be rejected.|Difference between 2 percentages|-0.11|||||TWO_SIDED|95.0|-3.11|2.93||||||Meningococcal serogroup A: The null hypothesis (H0: pm - ppm \> δ) was tested against the alternative hypothesis (H1: pm - ppm ≤ δ), where pm and ppm were the proportions of subjects in Group 1 and in Group 2, respectively, who achieved a Menactra vaccine response for meningococcal serogroups A, C, Y and W-135, with δ = 0.10.||2.93|-3.11|
72329408|NCT01659996|144184267|NON_INFERIORITY_OR_EQUIVALENCE|If the upper limit of the two-sided 95% CI of the difference between the two proportions was \< δ for serogroup C and assuming the difference between the two proportions was normally distributed, the inferiority assumption was to be rejected.|Difference between 2 percentages|1.27|||||TWO_SIDED|95.0|-0.84|3.64||||||Meningococcal serogroup C: The null hypothesis (H0: pm - ppm \> δ) was tested against the alternative hypothesis (H1: pm - ppm ≤ δ), where pm and ppm were the proportions of subjects in Group 1 and in Group 2, respectively, who achieved a Menactra vaccine response for meningococcal serogroups A, C, Y and W-135, with δ = 0.10.||3.64|-0.84|
72329409|NCT01659996|144184267|NON_INFERIORITY_OR_EQUIVALENCE|If the upper limit of the two-sided 95% CI of the difference between the two proportions was \< δ for serogroup Y and assuming the difference between the two proportions was normally distributed, the inferiority assumption was to be rejected.|Difference between 2 percentages|2.46|||||TWO_SIDED|95.0|0.14|5.14||||||Meningococcal serogroup Y: The null hypothesis (H0: pm - ppm \> δ) was tested against the alternative hypothesis (H1: pm - ppm ≤ δ), where pm and ppm were the proportions of subjects in Group 1 and in Group 2, respectively, who achieved a Menactra vaccine response for meningococcal serogroups A, C, Y and W-135, with δ = 0.10.||5.14|0.14|
72329410|NCT01659996|144184267|NON_INFERIORITY_OR_EQUIVALENCE|If the upper limit of the two-sided 95% CI of the difference between the two proportions was \< δ for serogroup W-135 and assuming the difference between the two proportions was normally distributed, the inferiority assumption was to be rejected.|Difference between 2 percentages|1.28|||||TWO_SIDED|95.0|-0.84|3.67||||||Meningococcal serogroup W-135: The null hypothesis (H0: pm - ppm \> δ) was tested against the alternative hypothesis (H1: pm - ppm ≤ δ), where pm and ppm were the proportions of subjects in Group 1 and in Group 2, respectively, who achieved a Menactra vaccine response for meningococcal serogroups A, C, Y and W-135, with δ = 0.10.||3.67|-0.84|
72329411|NCT01659996|144184272|NON_INFERIORITY_OR_EQUIVALENCE|Assuming that the antibodies concentration was log normally distributed, if the upper limit of the two-sided 95% CI of the ratio of the two GMCs is ≤ 1.5 for each antigen, the inferiority assumption was to be rejected.|Mean Difference (Final Values)|0.949|||||TWO_SIDED|95.0|0.852|1.06||||||Pertussis toxoid (PT): The null hypothesis (H0: GMCp / GMCpm \> 1.5) was tested against the alternative hypothesis (H1: GMCp / GMCpm ≤ 1.5), where GMCp and GMCpm were the GMCs of antibodies against the pertussis antigen (PT) in Group 3 and in Group 2, respectively||1.06|0.852|
72329412|NCT01659996|144184272|NON_INFERIORITY_OR_EQUIVALENCE|Assuming that the antibodies concentration was log normally distributed, if the upper limit of the two-sided 95% CI of the ratio of the two GMCs is ≤ 1.5 for each antigen, the inferiority assumption was to be rejected.|Mean Difference (Final Values)|0.968|||||TWO_SIDED|95.0|0.866|1.08||||||Filamentous hemagglutinin (FHA): The null hypothesis (H0: GMCp / GMCpm \> 1.5) was tested against the alternative hypothesis (H1: GMCp / GMCpm ≤ 1.5), where GMCp and GMCpm were the GMCs of antibodies against the pertussis antigen (FHA) in Group 3 and in Group 2, respectively||1.08|0.866|
72329413|NCT01659996|144184272|NON_INFERIORITY_OR_EQUIVALENCE|Assuming that the antibodies concentration was log normally distributed, if the upper limit of the two-sided 95% CI of the ratio of the two GMCs is ≤ 1.5 for each antigen, the inferiority assumption was to be rejected.|Mean Difference (Final Values)|1.11|||||TWO_SIDED|95.0|0.937|1.31||||||Pertactin (PRN): The null hypothesis (H0: GMCp / GMCpm \> 1.5) was tested against the alternative hypothesis (H1: GMCp / GMCpm ≤ 1.5), where GMCp and GMCpm were the GMCs of antibodies against the pertussis antigen (PRN) in Group 3 and in Group 2, respectively||1.31|0.937|
72329414|NCT01659996|144184273|NON_INFERIORITY_OR_EQUIVALENCE|If the upper limit of the two-sided 95% CI of the difference between the two proportions was \< δ for each antibody and assuming the difference between the two proportions was normally distributed, the inferiority assumption was to be rejected.|Difference between 2 percentages|-1.22|||||TWO_SIDED|95.0|-5.44|3.19||||||Pertussis toxoid (PT) antigen: The null hypothesis (H0: pp - ppm \> δ) was tested against the alternative hypothesis (H1: pp - ppm ≤ δ), where pp and ppm were the proportions of subjects in Group 3 and Group 2, respectively, who achieved a pertussis vaccine response in antibodies against the pertussis antigen (PT), with δ = 0.10.||3.19|-5.44|
72329415|NCT01659996|144184273|NON_INFERIORITY_OR_EQUIVALENCE|If the upper limit of the two-sided 95% CI of the difference between the two proportions was \< δ for each antibody and assuming the difference between the two proportions was normally distributed, the inferiority assumption was to be rejected.|Difference between 2 percentages|0.867|||||TWO_SIDED|95.0|-2.54|4.53||||||Filamentous hemagglutinin (FHA) antigen: The null hypothesis (H0: pp - ppm \> δ) was tested against the alternative hypothesis (H1: pp - ppm ≤ δ), where pp and ppm were the proportions of subjects in Group 3 and Group 2, respectively, who achieved a pertussis vaccine response in antibodies against the pertussis antigen (FHA), with δ = 0.10.||4.53|-2.54|
72329416|NCT01659996|144184273|NON_INFERIORITY_OR_EQUIVALENCE|If the upper limit of the two-sided 95% CI of the difference between the two proportions was \< δ for each antibody and assuming the difference between the two proportions was normally distributed, the inferiority assumption was to be rejected.|Difference between 2 percentages|-0.092|||||TWO_SIDED|95.0|-3.62|3.66||||||Pertactin (PRN) antigen: The null hypothesis (H0: pp - ppm \> δ) was tested against the alternative hypothesis (H1: pp - ppm ≤ δ), where pp and ppm were the proportions of subjects in Group 3 and Group 2, respectively, who achieved a pertussis vaccine response in antibodies against the pertussis antigen (PRN), with δ = 0.10.||3.66|-3.62|
72329417|NCT00375674|144184278|SUPERIORITY||Cox Proportional Hazard|0.761||||0.03|TWO_SIDED|95.0|0.594|0.975|||Cox Proportional hazards model|Based on the Cox Proportional hazards model stratified by UISS High-Risk Group.||Superiority analysis||0.975|0.594|0.030
72329418|NCT00375674|144184279|SUPERIORITY||Cox Proportional Hazard|0.811||||0.077|TWO_SIDED|95.0|0.643|1.023|||Cox Proportional hazards model|Based on the Cox Proportional hazards model stratified by UISS High-Risk Group||Superiority analysis||1.023|0.643|0.077
72329419|NCT00375674|144184280|SUPERIORITY||Hazard Ratio (HR)|0.929||||0.661|TWO_SIDED|95.0|0.67|1.289|||Log-rank test|||Hazard ratio was based on the Cox Proportional hazards model stratified by UISS High-Risk Group.||1.289|0.670|0.661
72329532|NCT04283656|144184524|EQUIVALENCE|The no-effect (bioequivalence) boundaries of 80%-125% were used.|Geometric mean ratio|0.97|||||TWO_SIDED|90.0|0.76|1.24||A two-sided significance level of 0.05 with a mean ratio of 1 for no effect was assumed.||A post hoc power analysis determined 80% power would be achieved for 6 subjects to detect an effect size of 1.43 or greater at 5% significance level.|Ratio represents Treatment C (Single-dose oral doravirine/lamivudine/tenofovir disoproxil fumarate co-administered with estradiol and spironolactone) over Treatment A (Single-dose oral doravirine/lamivudine/tenofovir disoproxil fumarate alone)|6 participants completed the study and were included in the pharmacokinetic analysis. As all participants received the same treatment groups but not necessarily in the same order, calculations were done between arms (Sequence E and F). 10 subjects was determined to achieve 80% power to reject the null hypothesis (geometric mean ratio for doravirine AUC falls outside of the no-effect boundaries) with two-sided significance level of 0.05 assuming a mean ratio of 1 for no effect.||1.24|0.76|
72329533|NCT04283656|144184525|EQUIVALENCE|The no-effect (bioequivalence) boundaries of 80%-125% were used.|Geometric mean ratio|0.93|||||TWO_SIDED|90.0|0.66|1.32||A two-sided significance level of 0.05 with a mean ratio of 1 for no effect was assumed.||A post hoc power analysis determined 80% power would be achieved for 6 subjects to detect an effect size of 1.43 or greater at 5% significance level.|Ratio represents Treatment C (Single-dose oral doravirine/lamivudine/tenofovir disoproxil fumarate co-administered with estradiol and spironolactone) over Treatment A (Single-dose oral doravirine/lamivudine/tenofovir disoproxil fumarate alone)|6 participants completed the study and were included in the pharmacokinetic analysis. As all participants received the same treatment groups but not necessarily in the same order, calculations were done between arms (Sequence E and F). 10 subjects was determined to achieve 80% power to reject the null hypothesis (geometric mean ratio for doravirine Cmax falls outside of the no-effect boundaries) with two-sided significance level of 0.05 assuming a mean ratio of 1 for no effect.||1.32|0.66|
72329534|NCT04283656|144184526|EQUIVALENCE|The no-effect (bioequivalence) boundaries of 80%-125% were used.|Geometric mean ratio|0.97|||||TWO_SIDED|90.0|0.76|1.24||A two-sided significance level of 0.05 with a mean ratio of 1 for no effect was assumed.||A post hoc power analysis determined 80% power would be achieved for 6 subjects to detect an effect size of 1.43 or greater at 5% significance level.|Ratio represents Treatment C (Single-dose oral doravirine/lamivudine/tenofovir disoproxil fumarate co-administered with estradiol and spironolactone) over Treatment A (Single-dose oral doravirine/lamivudine/tenofovir disoproxil fumarate alone)|6 participants completed the study and were included in the pharmacokinetic analysis. As all participants received the same treatment groups but not necessarily in the same order, calculations were done between arms (Sequence E and F). 10 subjects was determined to achieve 80% power to reject the null hypothesis (geometric mean ratio for doravirine C24 falls outside of the no-effect boundaries) with two-sided significance level of 0.05 assuming a mean ratio of 1 for no effect.||1.24|0.76|
72329535|NCT04283656|144184527|EQUIVALENCE|The no-effect (bioequivalence) boundaries of 80%-125% were used.|Geometric mean ratio|1.17|||||TWO_SIDED|90.0|0.91|1.5||A two-sided significance level of 0.05 with a mean ratio of 1 for no effect was assumed.||A post hoc power analysis determined 80% power would be achieved for 6 subjects to detect an effect size of 1.43 or greater at 5% significance level.|Ratio represents Treatment C (Single-dose oral doravirine/lamivudine/tenofovir disoproxil fumarate co-administered with estradiol and spironolactone) over Treatment A (Single-dose oral doravirine/lamivudine/tenofovir disoproxil fumarate alone)|6 participants completed the study and were included in the pharmacokinetic analysis. As all participants received the same treatment groups but not necessarily in the same order, calculations were done between arms (Sequence E and F). 10 subjects was determined to achieve 80% power to reject the null hypothesis (geometric mean ratio for tenofovir AUC falls outside of the no-effect boundaries) with two-sided significance level of 0.05 assuming a mean ratio of 1 for no effect.||1.50|0.91|
72329536|NCT04283656|144184528|EQUIVALENCE|The no-effect (bioequivalence) boundaries of 80%-125% were used.|Geometric mean ratio|1.38|||||TWO_SIDED|90.0|0.73|2.6||A two-sided significance level of 0.05 with a mean ratio of 1 for no effect was assumed.||A post hoc power analysis determined 80% power would be achieved for 6 subjects to detect an effect size of 1.43 or greater at 5% significance level.|Ratio represents Treatment C (Single-dose oral doravirine/lamivudine/tenofovir disoproxil fumarate co-administered with estradiol and spironolactone) over Treatment A (Single-dose oral doravirine/lamivudine/tenofovir disoproxil fumarate alone)|6 participants completed the study and were included in the pharmacokinetic analysis. As all participants received the same treatment groups but not necessarily in the same order, calculations were done between arms (Sequence E and F). 10 subjects was determined to achieve 80% power to reject the null hypothesis (geometric mean ratio for tenofovir Cmax falls outside of the no-effect boundaries) with two-sided significance level of 0.05 assuming a mean ratio of 1 for no effect.||2.60|0.73|
72329537|NCT04283656|144184529|EQUIVALENCE|The no-effect (bioequivalence) boundaries of 80%-125% were used.|Geometric mean ratio|1.14|||||TWO_SIDED|90.0|0.93|1.4||A two-sided significance level of 0.05 with a mean ratio of 1 for no effect was assumed.||A post hoc power analysis determined 80% power would be achieved for 6 subjects to detect an effect size of 1.43 or greater at 5% significance level.|Ratio represents Treatment C (Single-dose oral doravirine/lamivudine/tenofovir disoproxil fumarate co-administered with estradiol and spironolactone) over Treatment A (Single-dose oral doravirine/lamivudine/tenofovir disoproxil fumarate alone)|6 participants completed the study and were included in the pharmacokinetic analysis. As all participants received the same treatment groups but not necessarily in the same order, calculations were done between arms (Sequence E and F). 10 subjects was determined to achieve 80% power to reject the null hypothesis (geometric mean ratio for tenofovir C24 falls outside of the no-effect boundaries) with two-sided significance level of 0.05 assuming a mean ratio of 1 for no effect.||1.40|0.93|
72368818|NCT02637037|144247321|NON_INFERIORITY_OR_EQUIVALENCE|If the 90% CIs for both dapagliflozin and metformin geometric mean ratio of AUC is entirely contained within an 80.00% to 125.00% interval, it will be concluded the 2 manufacturing sites are bioequivalent.|Ratios of Geometric means|0.98|||||TWO_SIDED|90.0|0.92|1.04||||||Metformin: Statistical Assessment of Bioequivalence for Metformin following administration Dapagliflozin/Metformin XR 5/500 mg for Treatment C and D.||1.04|0.92|
72368819|NCT02637037|144247321|NON_INFERIORITY_OR_EQUIVALENCE|If the 90% CIs for both dapagliflozin and metformin geometric mean ratio of AUC is entirely contained within an 80.00% to 125.00% interval, it will be concluded the 2 manufacturing sites are bioequivalent.|Ratios of geometric means|1.0|||||TWO_SIDED|90.0|0.95|1.06||||||Metformin: Statistical Assessment of Bioequivalence for Metformin following administration Dapagliflozin/Metformin XR 10/1000 mg for Treatment E and F.||1.06|0.95|
72329538|NCT04283656|144184530|EQUIVALENCE|The no-effect (bioequivalence) boundaries of 80%-125% were used.|Geometric mean ratio|0.97|||||TWO_SIDED|90.0|0.7|1.35||A two-sided significance level of 0.05 with a mean ratio of 1 for no effect was assumed.||A post hoc power analysis determined 80% power would be achieved for 6 subjects to detect an effect size of 1.43 or greater at 5% significance level.|Ratio represents Treatment C (Single-dose oral doravirine/lamivudine/tenofovir disoproxil fumarate co-administered with estradiol and spironolactone) over Treatment B (Single-dose estradiol and spironolactone co-administered with placebo)|6 participants completed the study and were included in the pharmacokinetic analysis. As all participants received the same treatment groups but not necessarily in the same order, calculations were done between arms (Sequence E and F). 10 subjects was determined to achieve 80% power to reject the null hypothesis (geometric mean ratio for estradiol AUC falls outside of the no-effect boundaries) with two-sided significance level of 0.05 assuming a mean ratio of 1 for no effect.||1.35|0.70|
72329539|NCT04283656|144184531|EQUIVALENCE|The no-effect (bioequivalence) boundaries of 80%-125% were used.|Geometric mean ratio|1.12|||||TWO_SIDED|90.0|0.92|1.36||A two-sided significance level of 0.05 with a mean ratio of 1 for no effect was assumed.||A post hoc power analysis determined 80% power would be achieved for 6 subjects to detect an effect size of 1.43 or greater at 5% significance level.|Ratio represents Treatment C (Single-dose oral doravirine/lamivudine/tenofovir disoproxil fumarate co-administered with estradiol and spironolactone) over Treatment B (Single-dose estradiol and spironolactone co-administered with placebo)|6 participants completed the study and were included in the pharmacokinetic analysis. As all participants received the same treatment groups but not necessarily in the same order, calculations were done between arms (Sequence E and F). 10 subjects was determined to achieve 80% power to reject the null hypothesis (geometric mean ratios for estradiol Cmax falls outside of the no-effect boundaries) with two-sided significance level of 0.05 assuming a mean ratio of 1 for no effect.||1.36|0.92|
72329540|NCT04283656|144184532|EQUIVALENCE|The no-effect (bioequivalence) boundaries of 80%-125% were used.|Geometric mean ratio|1.09|||||TWO_SIDED|90.0|0.88|1.35||A two-sided significance level of 0.05 with a mean ratio of 1 for no effect was assumed.||A post hoc power analysis determined 80% power would be achieved for 6 subjects to detect an effect size of 1.43 or greater at 5% significance level.|Ratio represents Treatment C (Single-dose oral doravirine/lamivudine/tenofovir disoproxil fumarate co-administered with estradiol and spironolactone) over Treatment B (Single-dose estradiol and spironolactone co-administered with placebo)|6 participants completed the study and were included in the pharmacokinetic analysis. As all participants received the same treatment groups but not necessarily in the same order, calculations were done between arms (Sequence E and F). 10 subjects was determined to achieve 80% power to reject the null hypothesis (geometric mean ratios for estradiol C12 falls outside of the no-effect boundaries) with two-sided significance level of 0.05 assuming a mean ratio of 1 for no effect.||1.35|0.88|
72329541|NCT00935493|144184533|SUPERIORITY_OR_OTHER|||||||0.06|||||||Regression, Linear|||||||0.06
72421664|NCT00803101|144354597|NON_INFERIORITY_OR_EQUIVALENCE|"The non-inferiority margin was -(minus)10%. If the lower limit of the 2-sided 95% CI was \>-10%, then the null-hypothesis was rejected and it was concluded that Beriplex was non-inferior to plasma.~The sample size estimation assumed that hemostatic efficacy would be rated 'effective' in 85% of participants in the plasma group and 90% of participants in the Beriplex group. The power to show non-inferiority with these assumptions was greater than 80% for two treatment groups of 80 participants."|Difference in effective hemostasis (%)|14.3|||||TWO_SIDED|95.0|2.8|25.8||No P-value is provided as non-inferiority was assessed via calculation of the 95% CI for the difference (Beriplex minus plasma) in the percentage of participants with effective hemostasis.|95% confidence interval|The Newcombe-Wilson score method was used to estimate the 95% CI for the difference (Beriplex-plasma) in the % participants with effective hemostasis||The analysis of hemostatic efficacy was via calculation of the 95% confidence interval (CI) for the difference (Beriplex minus plasma) in the percentage of participants with effective hemostasis.||25.8|2.8|
72421665|NCT00803101|144354598|NON_INFERIORITY_OR_EQUIVALENCE|"The non-inferiority margin was -(minus)10%. If the lower limit of the 2-sided 95% CI was \>-10%, then the null-hypothesis was rejected and it was concluded that Beriplex was non-inferior to plasma.~The sample size estimation assumed that hemostatic efficacy would be rated 'effective' in 85% of participants in the plasma group and 90% of participants in the Beriplex group. The power to show non-inferiority with these assumptions was greater than 80% for two treatment groups of 80 participants."|Difference in effective hemostasis (%)|45.3|||||TWO_SIDED|95.0|31.9|56.4||No P-value is provided as non-inferiority was assessed via calculation of the 95% CI for the difference (Beriplex minus plasma) in the percentage of participants with effective hemostasis.|Newcombe-Wilson score method|The Newcombe-Wilson score method was used to estimate the 95% CI for the difference (Beriplex-plasma) in the % pts with rapid decrease of the INR.||The analysis of rapid decrease of the INR was via calculation of the 95% CI for the difference (Beriplex minus plasma) in the percentage of participants with INR ≤ 1.3 at 30 minutes after the end of infusion.||56.4|31.9|
72329542|NCT00935493|144184533|SUPERIORITY_OR_OTHER|||||||0.47|||||||Regression, Linear|||||||0.47
72329543|NCT00935493|144184534|SUPERIORITY_OR_OTHER|||||||0.67|||||||Regression, Logistic|||||||0.67
72329544|NCT00935493|144184534|SUPERIORITY_OR_OTHER|||||||0.46|||||||Regression, Logistic|||||||0.46
72329545|NCT00935493|144184535|SUPERIORITY_OR_OTHER|||||||0.65|||||||Regression, Linear|||||||0.65
72329546|NCT00935493|144184535|SUPERIORITY_OR_OTHER|||||||0.46|||||||Regression, Linear|||||||0.46
72329547|NCT02565147|144184545|SUPERIORITY|||||||0.7505|||||||Wilcoxon Rank Sum Test|||||||0.7505
72329548|NCT00289289|144184603|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1|STANDARD_DEVIATION|4.8||0.629|ONE_SIDED|95.0||0.5||P-value is from a paired t-test since each subject had the intervention pacing features turned ON and OFF in this crossover study|t-test, 1 sided|One-sided paired t-test with 221 degrees of freedom|A mean difference greater than zero indicates an average increase in atrial fibrillation/atrial tachycardia symptomatic episodes while the intervention pacing features were programmed ON versus OFF.|Null Hypothesis: rate of symptomatic atrial tachycardia/atrial fibrillation episodes during periods when intervention pacing features ON is greater to or equal to the rate of symptomatic atrial tachycardia/atrial fibrillation episodes during periods where intervention pacing features were programmed OFF Alternative Hypothesis: rate of symptomatic AT/AF during periods of ON programming is less than the rate of symptomatic AT/AF during OFF programming||0.5||0.629
72329549|NCT00289289|144184604|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-1.0||||0.165|||||||Wilcoxon (Mann-Whitney)|P-value is from Koch's adaptation to the Wilcoxon Rank-Sum test comparing the within subject ON minus OFF differences to 0|A negative change means an improvement in AF symptom frequency with intervention pacing therapy programmed ON. Total possible improvement while intervention features are programmed ON is -64. Total possible worsening during ON programming is 64.|"The null hypothesis is that the symptom frequency score does not differ between while intervention pacing features were programmed ON versus OFF.~This secondary objective was not powered."||||0.165
72329550|NCT00289289|144184605|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.82||||0.603|TWO_SIDED|95.0|0.39|1.73||P-value is based on a repeated measures Cox proportional hazards model to the rate of AF cardioversion attempts between periods of ON and OFF programming|Regression, Cox||Hazard Ratio compares rate of first attempted cardioversion for AF while the intervention pacing features were programmed ON versus OFF.|"Null Hypothesis: AF Cardioversion attempt rate is the same during periods of ON and OFF programming~Alternative Hypothesis: AF Cardioversion attempt rate is different during periods of ON and OFF programming"||1.73|0.39|0.603
72329551|NCT00289289|144184606|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.0||||0.394||95.0||||Within each randomized subject, the ON minus OFF difference in AT/AF burden was computed. The Wilcoxon Signed-Rank test was used to determine if the ON minus OFF difference in AT/AF burden was different from zero.|Wilcoxon (Mann-Whitney)||A negative median difference represents an improvement (lessening) of AT/AF burden during periods of ON versus OFF programming. A positive median difference represents an increase in AT/AF burden during ON compared to OFF programming.|Null Hypothesis: There is no difference in AT/AF burden during periods on ON and OFF programming Alternative Hypothesis: AT/AF burden is lower during periods of ON programming compared to periods of OFF programming||||0.394
72329552|NCT01696981|144184681|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.98|||||TWO_SIDED|95.0|0.95|1.0|||Poisson regression|||||1.00|0.95|
72329553|NCT01696981|144184683|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.79|||||TWO_SIDED|95.0|0.72|0.85|||Poisson regression|||||0.85|0.72|
72329554|NCT01696981|144184685|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.74|||||TWO_SIDED|95.0|0.63|0.87|||Poisson regression|||||0.87|0.63|
72329555|NCT01433042|144184754|SUPERIORITY_OR_OTHER||percentage|98.0||||||||||since the study results analysis is purley discriptive no P value and confidence interval was used for the analysis|percentage|percentage of SB3 images graded as superior in image quality to SB2|since the study results analysis is purley discriptive no P value and confidence interval was used for the analysis|"Primary Endpoint~o Physician's subjective assessment questionnaire was evaluated in a quality manner.~The physicians were required to assess the performance of SB3 system as compare to SB2 by answering a short questionnaire.~The physicians were requested to indicate whether capsule SB3 was better as compared to SB2."||||
72329556|NCT00281099|144184757|NON_INFERIORITY_OR_EQUIVALENCE|A non-inferiority analysis was performed, with the hazard ratio as the parameter of interest and the non-inferiority threshold of 1.21. The one-sided upper confidence bound for the hazard ratio had to be less than 1.21 for the null hypothesis to be rejected. The threshold of 1.21 was derived by using a noninferiority threshold of a 5 percentage point difference in 24 month event-free rates.|Hazard Ratio (HR)|1.139||||||96.3|1.139|1.59||There were 167 events by 90 subjects in the VVI 40 arm, compared to 188 events among 104 subjects in the MVP arm.|Andersen-Gill Model|An Andersen-Gill model was used to account for multiple primary endpoints per subject.|4 interim analyses were performed \& the O'Brien-Fleming alpha-spending function required a 96.3% confidence interval.|"This is a multiple events survival analysis, with time to first primary endpoint, time between successive endpoints, and time from last endpoint to last follow-up visit determined for each subject. The null hypothesis is that the mortality/ heart failure (HF) urgent care/HF hospitalization hazard rate for patients with no Class I pacing indication and MVP is greater than that of similar patients with VVI 40."||1.590|1.139|
72329557|NCT00281099|144184758|NON_INFERIORITY_OR_EQUIVALENCE|A non-inferiority analysis was performed, with the hazard ratio as the parameter of interest and the non-inferiority threshold of 1.241. The one-sided upper confidence bound for the hazard ratio had to be less than 1.241 for the null hypothesis to be rejected. The threshold of 1.241 was derived by using a non-inferiority threshold of a 5 percentage point difference in 24 month HF event-free rates.|Hazard Ratio (HR)|1.029||||||95.0|1.029|1.381|||Andersen-Gill Model|An Andersen-Gill model was utilized to account for multiple HF events per subject.||This is a multiple events survival analysis, and so the time from randomization to first HF event, time between successive HF events, and time from last HF event to last follow-up visit was determined for each subject. Since non-inferiority analysis is intended to prove that one therapy is equivalent or superior to another therapy, the null hypothesis being tested is that the worsening HF hazard rate for patients with MVP programming is greater than that of patients with VVI 40 programming.||1.381|1.029|
72329558|NCT00281099|144184759|SUPERIORITY_OR_OTHER||||||>|0.05||95.0||||The a priori alpha level for each covariate was 0.05. The p-value outcome provided is for the randomization arm main effect and all interactions between randomization arm and time.|Cumulative Logits Model|The analysis included data for all four time points (baseline, 12, 24, and 36 months) and all NYHA levels.||A model with covariates for time and randomization arm was fit to test the null hypothesis that the risk of worsening NYHA status over time among patients with MVP programming was equal to that of patients with VVI 40 programming. This analysis combined NYHA IV and Death into one category. The model included interaction terms for time and randomization arm.||||> 0.05
72329559|NCT00281099|144184759|SUPERIORITY_OR_OTHER||||||>|0.05||95.0||||The a priori alpha level for each covariate was 0.05. The p-value outcome provided is for the randomization arm main effect and all interaction terms between randomization arm and time.|Cumulative Logit Model|The analysis included data for all four time points (baseline, 12, 24, and 36 months) and all NYHA levels.||The null hypothesis for this analysis was the same as for the prior analysis: that the risk of worsening NYHA status over time among patients with MVP programming was equal to that of patients with VVI 40 programming. In this analysis, however, death was considered a 5th category in addition to NYHA I-IV. An interaction term for time and randomization arm was also included.||||> 0.05
72368820|NCT02637037|144247321|NON_INFERIORITY_OR_EQUIVALENCE|If the 90% CIs for both dapagliflozin and metformin geometric mean ratio of AUC is entirely contained within an 80.00% to 125.00% interval, it will be concluded the 2 manufacturing sites are bioequivalent.|Ratios of Geometric means|1.02|||||TWO_SIDED|90.0|0.94|1.1||||||Metformin: Statistical Assessment of Bioequivalence for Metformin following administration Dapagliflozin/Metformin XR 10/1000 mg for Treatment G and H.||1.10|0.94|
72329560|NCT00281099|144184760|SUPERIORITY_OR_OTHER||||||>|0.1||95.0||||In each case the a priori threshold for significance for Arm was 0.05.|Mixed Models Analysis|Model fit with time and arm as covariates, the interaction between them included. Interaction shown to not be significant and model refit without it.||A linear mixed model was fit for each of the followoing: LVEDD, LVESD, Septal Wall Thickness, and Posterior Wall Thickness; the purpose was to test whether patients with MVP and no pacing indication over time had a different average value for that measure than patients with VVI and no pacing indication. Data were also collected from the 36 month visits but were excluded due to the trial being stopped early and only a subset of patients having data for those visits.||||> 0.10
72329561|NCT00281099|144184761|SUPERIORITY_OR_OTHER||||||>|0.1||95.0||||The a priori threshold for significance for Arm was 0.05, with no adjustment for multiple analyses.|Mixed Models Analysis|Models were fit with time and arm as covariates.||A linear mixed model was fit for each of the following: LV Ejection Fraction and LV Fractional Shortening; the purpose was to test whether patients with MVP and no pacing indication over time had a different average value for that measure than patients with VVI and no pacing indication. Two-sided tests were used. Data were also collected from the 36 month visits but were excluded due to the trial being stopped early and only a subset of patients having data for those visits.||||> 0.10
72329562|NCT00281099|144184762|SUPERIORITY_OR_OTHER|||||||0.0424||95.0||||The a priori threshold for statistical significance for Arm was 0.05, with no correction for multiple comparisons.|Mixed Models Analysis|The model was fit with time and arm as covariates.||"A linear mixed model was fit to test whether patients with MVP and no pacing indication had a different values for left ventricular end diastolic volume (LVEDV) over time than similar patients with VVI 40. A two-sided test was used. Data were collected from the 36 month visits but were excluded due to the trial being stopped early and only a subset of patients having data for those visits."||||0.0424
72329563|NCT00281099|144184762|SUPERIORITY_OR_OTHER||||||>|0.1||95.0||||In each case the a priori threshold for significance for Arm was 0.05.|Mixed Models Analysis|Models were fit with time and arm as covariates.||"Similar models were fit for left ventricle (LV) End Systolic Volume and Left Atrial Volume."||||>0.10
72329564|NCT00281099|144184763|SUPERIORITY_OR_OTHER|||||||0.0418||95.0||||The a priori threshold for significance for Arm was 0.05, with no adjustment for multiple analyses.|Mixed Models Analysis|The model fit with time and arm as covariates.||A linear mixed model was fit to test whether patients with MVP and no pacing indication had a different values of Left Ventricular Sphericity Index over time than similar patients with VVI 40. A two-sided test was used. Data were collected from the 36 month visits but were excluded due to the trial being stopped early and only a subset of patients having data for those visits.||||0.0418
72329565|NCT00281099|144184764|SUPERIORITY_OR_OTHER||||||>|0.1||95.0||||The a priori threshold for statistical significance for Arm was 0.05, with no correction for multiple comparisons.|Mixed Models Analysis|Models were fit with time and arm as covariates.||A linear mixed model was fit for each of the following: TR Velocity, Mitral Inflow-peak E and Mitral Inflow-peak A; the purpose was to test whether patients with MVP and no pacing indication over time had a different average value for that measure than patients with VVI and no pacing indication. Two-sided tests were used. Data were collected from the 36 month visits but were excluded due to the trial being stopped early and only a subset of patients having data for those visits.||||> 0.10
72329566|NCT00281099|144184765|SUPERIORITY_OR_OTHER|||||||0.949||95.0||||The a priori threshold for significance for Arm was 0.05, with no adjustment for multiple analyses.|Mixed Models Analysis|Model fit with time and arm as covariates.||A linear mixed model was fit for Mitral Inflow - Deceleration time; the purpose was to test whether patients with MVP and no pacing indication over time had a different average value for that measure than patients with VVI and no pacing indication. A two-sided test was used. Data were collected from the 36 month visits but were excluded due to the trial being stopped early and only a subset of patients having data for those visits.||||0.9490
72329567|NCT00281099|144184766|SUPERIORITY_OR_OTHER||||||>|0.1||95.0||||The a priori threshold for significance for Arm was 0.05, with no adjustment for multiple analyses.|Mixed Models Analysis|Models fit with time and arm as covariates.||A linear mixed model was fit for each of the following: Left Atrial Area and Mitral Regurgitation Area; the purpose was to test whether patients with MVP and no pacing indication over time had a different average value for that measure than patients with VVI and no pacing indication. Two-sided tests were used. Data were collected from the 36 month visits but were excluded due to the trial being stopped early and only a subset of patients having data for those visits.||||> 0.10
72329568|NCT00281099|144184767|SUPERIORITY_OR_OTHER|||||||0.8403||95.0||||The a priori threshold for significance for Arm was 0.05.|Cumulative Logits Model|Because Composite Mitral Regurgitation Score was measured on the ordinal scale, a GEE cumulative logits model was fit.||"A General Estimating Equation (GEE) Cumulative Logits model was fit with Arm, Time, and their interaction as covariates in the model to test the hypothesis that patients with no pacing indication and MVP programming have different Mitral Regurgation over time than similar patients with VVI 40 programming. A two-sided test was used. Data were collected from the 36 month visits but were excluded due to the trial being stopped early and only a subset of patients having data for those visits."||||0.8403
72329569|NCT00281099|144184768|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.949||||||95.0|0.949|1.209|||Andersen-Gill model|This model was fit to account for multiple events (i.e. days in which true VT/VF occurred) within subject.|Because of the possible correlation within subject of days with episodes, a subsequent analysis was done using a bootstrap confidence interval for the annualized rate of episodes per patient month.|The pre-specified analysis called for a comparison of the hazard rates of true VT/VF between the two arms by way of a one-sided 95% confidence interval on the hazard ratio (values less than one favor MVP) after fitting a model. The unit of time was days, not episodes, so the analysis did not account for multiple episodes on the same day. If the upper bound was less than 1, the null hypothesis of equal hazard rates would be rejected.||1.209|0.949|
72329570|NCT00281099|144184768|SUPERIORITY_OR_OTHER||Difference in Annualized Rates|-0.015||||||95.0|-0.015|0.033|||Bootstrap Confidence Interval|||A 95% one-sided bootstrap confidence interval was generated for the MVP - VVI 40 difference in annualized rates of true VT/VF per patient month. If the interval upper bound was less than 0, the null hypothesis of equal rates would be rejected.||0.033|-0.015|
72553869|NCT05342597|144639789|OTHER|Estimated difference in least squares means and corresponding 90%CI of log-transformed PK parameters were back transformed to obtain the estimate and CI of the geometric mean ratio of each meal condition to the fasted state.|LS Mean Ratio|1.083|||||TWO_SIDED|90.0|0.821|1.429|||ANOVA|||PK parameters of unchanged edaravone were analyzed for the assessments of food effect on PK.||1.429|0.821|
72329571|NCT00281099|144184768|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.31||||||95.0|1.31|1.858|||Andersen-Gill model|This model was fit to account for multiple events (i.e. days in which non-VT/VF detected by device as VT/VF) within subject.|Because of the possible correlation within a subject for days with episodes, a subsequent analysis was done using a bootstrap confidence interval for the annualized rate of episodes per patient month.|The pre-specified analysis called for a comparison of the hazard rates of inappropriately detected non-VT/VF between the two arms by way of a one-sided 95% confidence interval on the hazard ratio (MVP in numerator) after fitting a model. The unit of time was days, not episodes, so the analysis did not account for multiple episodes on the same day. If the upper bound was less than 1, the null hypothesis of equal hazard rates would be rejected.||1.858|1.310|
72329572|NCT00281099|144184768|SUPERIORITY_OR_OTHER||Difference in Annualized Rates|0.017||||||95.0|0.017|0.036|||Bootstrap Confidence Interval|||A 95% one-sided bootstrap confidence interval was generated for the MVP - VVI 40 difference in annualized rates of inappropriately detected non-VT/VF per patient month. If the interval upper bound was less than 0, the null hypothesis of equal rates would be rejected.||0.036|0.017|
72329573|NCT00281099|144184769|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.22||||0.7166||95.0|1.22|3.0||The threshold for significance was the one-sided upper confidence bound being less than 1.|Andersen-Gill model|||This analysis compared the hazard rates for clinically important AF (defined as a calendar day with \>20 hour of AT/AF as measured by the device). The null hypothesis was that this hazard rate for patients with MVP was equal to or greater than that of patients with VVI 40. The pre-specified model had Arm as a covariate, and accounted for time to first event and time between successive events per subject.||3.0|1.22|0.7166
72329574|NCT00281099|144184769|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.15|||||TWO_SIDED|95.0|-100.0|0.8||The threshold for significance was defined as the upper one-sided confidence bound being less than 0.|Bootstrap Confidence Interval|||This analysis compared the percentage of days with \>20 hours of AT/AF as measured by the device(definition of clinically important AF) between arms. The null hypothesis was that this percentage of days for patients with MVP was equal or greater to that of patients with VVI 40.||0.8|-100|
72329575|NCT00281099|144184769|SUPERIORITY_OR_OTHER|||||||0.325||95.0||||The a priori threshold for statistical significance was 0.05.|Log Rank|A one-sided test was used.||This analysis tested the null hypothesis that the hazard rate for development of persistent AF(defined as 2 consecutive visits presenting with AT/AF, 7 consecutive days of 22 or more hours per day of AT/AF, or \< 7 such days due to a cardioversion) in patients with MVP and no pacing indication was equal to or greater than that of similar patients with VVI 40.||||0.325
72329576|NCT00281099|144184769|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||||95.0|0.0|0.145||The a priori threshold for significance was defined as the one-sided upper 95% confidence bound for the MVP - VVI 40 difference in average AT/AF through 6 months being less than 0.|Bootstrap Confidence Interval|||This analysis tested the hypothesis that the average AT/AF burden (hours per day of AT/AF) through 6 months post-implant in patients with no Class I pacing indication and MVP is equal to or greater than that of similar patients with VVI 40. Only subjects with complete AT/AF data for this time interval were included in the analysis.||0.145|0|
72329577|NCT00281099|144184769|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||||95.0|0.0|0.227||The a priori threshold for significance was defined as the one-sided upper 95% confidence bound for the MVP - VVI 40 difference in average AT/AF burden from 6 to 12 months being less than 0.|Bootstrap Confidence Interval|||This analysis tested the hypothesis that the average AT/AF burden (hours per day of AT/AF) from 6 to 12 months post-implant in patients with no Class I pacing indication and MVP is equal to or greater than that of similar patients with VVI 40. Only subjects with complete AT/AF data for this time interval were included in the analysis.||0.227|0|
72329578|NCT00281099|144184769|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||||95.0|0.0|0.261||The a priori threshold for significance was defined as the one-sided upper 95% confidence bound for the MVP - VVI 40 difference in average AT/AF burden from 12 to 24 months being less than 0.|Bootstrap Confidence Interval|||This analysis tested the hypothesis that the average AT/AF burden (hours per day of AT/AF) from 12 to 24 months post-implant in patients with no Class I pacing indication and MVP is equal to or greater than that of similar patients with VVI 40. Only subjects with complete AT/AF data for this time interval were included in the analysis.||0.261|0|
72329579|NCT00281099|144184769|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||||95.0|-0.1|0.11||The a priori threshold for significance was defined as the one-sided upper 95% confidence bound for the MVP - VVI 40 difference in average AT/AF burden from 24 to 36 months being less than 0.|Bootstrap Confidence Interval|||This analysis tested the hypothesis that the average AT/AF burden (hours per day of AT/AF) from 24 to 36 months post-implant in patients with no Class I pacing indication and MVP is equal to or greater than that of similar patients with VVI 40. Only subjects with complete AT/AF data for this time interval were included in the analysis.||0.110|-0.1|
72329580|NCT00281099|144184770|SUPERIORITY_OR_OTHER|||||||0.0053||95.0||||The a priori threshold for statistical significance was 0.05. The threshold was met, and the null hypothesis rejected.|Log Rank|||Physicians recorded at each scheduled and unscheduled follow-up whether the subject had developed a Class I indication since their last visit. The time from randomization to Class I indication development or last visit if censored was determined for each subject. The null hypothesis was that the hazard rate for time to development of a Class I pacing indication among patients with MVP programming was equal to or greater than that of patients with VVI 40 programming.||||0.0053
72329581|NCT00281099|144184772|SUPERIORITY_OR_OTHER|||||||0.9791||95.0||||The one-sided Wilcoxon Rank Sum test yielded a p-value greater than 0.05, which was the a priori threshold for significance.|Wilcoxon (Mann-Whitney)|||All subjects from the analysis cohort with available data for the time period of interest were included in the corresponding analysis. The null hypothesis was that the average percent ventricular pacing through 6 months post-implant for patients with MVP programming and was greater than or equal to that of patients with VVI 40 programming.||||0.9791
72329582|NCT00281099|144184772|SUPERIORITY_OR_OTHER|||||||0.8984||95.0||||The one-sided Wilcoxon Rank Sum test yielded a p-value greater than 0.05, which was the a priori threshold for significance.|Wilcoxon (Mann-Whitney)|Alternative hypothesis:patients with MVP \& no pacing indication have less mean ventricular pacing through 12 months than similar patients with VVI 40.||All subjects from the analysis cohort with available data for the time period of interest were included in the corresponding analysis. The null hypothesis was that the average percent ventricular pacing through 12 months post-implant for patients with MVP programming was greater than or equal to that of patients with VVI 40 programming.||||0.8984
72329583|NCT00281099|144184772|SUPERIORITY_OR_OTHER|||||||0.7144||95.0||||The one-sided Wilcoxon Rank Sum test yielded a p-value greater than 0.05, which was the a priori threshold for significance.|Wilcoxon (Mann-Whitney)|Alternative hypothesis:patients with MVP \& no pacing indication have less mean ventricular pacing through 24 months than similar patients with VVI 40.||All subjects from the analysis cohort with available data for the time period of interest were included in the corresponding analysis. The null hypothesis was that the average percent ventricular pacing through 24 months post-implant for patients with MVP programming and no pacing indication was greater than or equal to that of patients with VVI 40 programming and no pacing indication.||||0.7144
72329584|NCT00281099|144184772|SUPERIORITY_OR_OTHER|||||||0.5165||95.0||||The one-sided Wilcoxon Rank Sum test yielded a p-value greater than 0.05, which was the a priori threshold for significance.|Wilcoxon (Mann-Whitney)|Alternative hypothesis:patients with MVP \& no pacing indication have less mean ventricular pacing through 36 months than similar patients with VVI 40.||All subjects from the analysis cohort with available data for the time period of interest were included in the corresponding analysis. The null hypothesis was that the average percent ventricular pacing through 36 months post-implant for patients with MVP programming and no pacing indication was greater than or equal to that of patients with VVI 40 programming and no pacing indication.||||0.5165
72329585|NCT00281099|144184773|SUPERIORITY_OR_OTHER|||||||0.0073||95.0||||The p-value is not adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|||For the KCCQ Physical Limitation Score, the change from baseline to 12 months was compared between the two arms, using a two-sided test. If a subject died prior to the time point, a score of 0 was imputed for their 12 month score.||||0.0073
72329586|NCT00281099|144184773|SUPERIORITY_OR_OTHER|||||||0.2493||95.0||||No adjustment was made for multiple comparisons, and the a priori threshold for statistical significance was 0.05.|Wilcoxon (Mann-Whitney)|||For the KCCQ Symptom Stability Score, the change from baseline to 12 months was compared between the two arms, using a two-sided test. If a subject died prior to the time point, a score of 0 was imputed for their 12 month score.||||0.2493
72329587|NCT00281099|144184773|SUPERIORITY_OR_OTHER|||||||0.7728||95.0||||The a priori threshold for statistical significance was 0.05, and no adjustment was made for multiple comparisons.|Wilcoxon (Mann-Whitney)|||For the KCCQ Symptom Frequency Score, the change from baseline to 12 months was compared between the two arms, using a two-sided test. If a subject died prior to the time point, a score of 0 was imputed for their 12 month score.||||0.7728
72329588|NCT00281099|144184773|SUPERIORITY_OR_OTHER|||||||0.3082||95.0||||The a priori threshold for statistical significance was 0.05, and no adjustment was made for multiple comparisons|Wilcoxon (Mann-Whitney)|||For the KCCQ Symptom Burden Score, the change from baseline to 12 months was compared between the two arms, using a two-sided test. If a subject died prior to the time point, a score of 0 was imputed for their 12 month score.||||0.3082
72329589|NCT00281099|144184773|SUPERIORITY_OR_OTHER|||||||0.5422||95.0||||The a priori threshold for statistical significance was 0.05, and no adjustment was made for multiple comparisons.|Wilcoxon (Mann-Whitney)|||For the KCCQ Total Symptom Score, the change from baseline to 12 months was compared between the two arms, using a two-sided test. If a subject died prior to the time point, a score of 0 was imputed for their 12 month score.||||0.5422
72329590|NCT00281099|144184773|SUPERIORITY_OR_OTHER|||||||0.0851||95.0||||The a priori threshold for statistical significance was 0.05, and no adjustment was made for multiple comparisons.|Wilcoxon (Mann-Whitney)|||For the KCCQ Self-Efficacy Score, the change from baseline to 12 months was compared between the two arms, using a two-sided test. If a subject died prior to the time point, a score of 0 was imputed for their 12 month score.||||0.0851
72329591|NCT00281099|144184773|SUPERIORITY_OR_OTHER|||||||0.0502||95.0||||The a priori threshold for statistical significance was 0.05, and no adjustment was made for multiple comparisons.|Wilcoxon (Mann-Whitney)|||For the KCCQ Quality of Life Score, the change from baseline to 12 months was compared between the two arms, using a two-sided test. If a subject died prior to the time point, a score of 0 was imputed for their 12 month score.||||0.0502
72329592|NCT00281099|144184773|SUPERIORITY_OR_OTHER|||||||0.0463||95.0||||The a priori threshold for statistical significance was 0.05, and no adjustment was made for multiple comparisons.|Wilcoxon (Mann-Whitney)|||For the KCCQ Social Limitation Score, the change from baseline to 12 months was compared between the two arms, using a two-sided test. If a subject died prior to the time point, a score of 0 was imputed for their 12 month score.||||0.0463
72329593|NCT00281099|144184773|SUPERIORITY_OR_OTHER|||||||0.0227||95.0||||The a priori threshold for statistical significance was 0.05, and no adjustment was made for multiple comparisons.|Wilcoxon (Mann-Whitney)|||For the KCCQ Overall Summary Score, the change from baseline to 12 months was compared between the two arms, using a two-sided test. If a subject died prior to the time point, a score of 0 was imputed for their 12 month score.||||0.0227
72329594|NCT00281099|144184773|SUPERIORITY_OR_OTHER|||||||0.0582||95.0||||The a priori threshold for statistical significance was 0.05, and no adjustment was made for multiple comparisons.|Wilcoxon (Mann-Whitney)|||For the KCCQ Overall Clinical Summary Score, the change from baseline to 12 months was compared between the two arms, using a two-sided test. If a subject died prior to the time point, a score of 0 was imputed for their 12 month score.||||0.0582
72329595|NCT00281099|144184773|SUPERIORITY_OR_OTHER||||||>|0.15||95.0||||Tests for all ten KCCQ subscores yielded p-values greater than 0.15 (the a priori threshold for statistical significance was 0.05).|Wilcoxon (Mann-Whitney)|||The 10 KCCQ analyses were repeated comparing changes from baseline to 24 months between arms. Again if a subject died prior to their 24 month visit, a value of 0 was imputed for their 24 month score.||||> 0.15
72329596|NCT00281099|144184773|SUPERIORITY_OR_OTHER||||||>|0.15||95.0||||Tests for all 10 KCCQ subscores yielded p-values greater than 0.15 (the a priori threshold for statistical significance was 0.05).|Wilcoxon (Mann-Whitney)|Because the trial was stopped early, only 178 subjects were included in these analyses.||The 10 KCCQ analyses were repeated comparing changes from baseline to 36 months between arms. Again if a subject died prior to their 36 month visit, a value of 0 was imputed for their 36 month score.||||> 0.15
72329597|NCT00281099|144184773|SUPERIORITY_OR_OTHER|||||||0.1399||95.0||||The a priori threshold for statistical significance was 0.05, and no adjustment was made for multiple comparisons.|Wilcoxon (Mann-Whitney)|||The change in Minnesota Living with Heart Failure Questionnaire score from baseline to 12 months was compared using a two-sided test. If a subject died before their 12 month visit, a value of 105 (worst possible MLWHF score) was imputed for their 12 month score.||||0.1399
72329598|NCT00281099|144184773|SUPERIORITY_OR_OTHER|||||||0.3573||95.0||||The a priori threshold for statistical significance was 0.05, and no adjustment was made for multiple comparisons.|Wilcoxon (Mann-Whitney)|||The change in Minnesota Living with Heart Failure Questionnaire score from baseline to 24 months was compared using a two-sided test. If a subject died before their 24 month visit, a value of 105 (worst possible MLWHF score) was imputed for their 24 month score.||||0.3573
72329599|NCT00281099|144184773|SUPERIORITY_OR_OTHER|||||||0.5183||95.0||||The a priori threshold for statistical significance was 0.05, with no adjustment made for multiple comparisons.|Wilcoxon (Mann-Whitney)|Because the trial was stopped early, only 178 subjects were included in this analysis.||The change in Minnesota Living with Heart Failure Questionnaire score from baseline to 36 months was compared using a two-sided test. If a subject died before their 36 month visit, a value of 105 (worst possible MLWHF score) was imputed for their 36 month score.||||0.5183
72329600|NCT00281099|144184774|NON_INFERIORITY_OR_EQUIVALENCE|A non-inferiority analysis was performed, with the hazard ratio as the parameter of interest and the non-inferiority threshold of 1.44. The one-sided upper confidence bound for the hazard ratio had to be less than 1.44 for the null hypothesis to be rejected. The threshold of 1.44 was derived by using a noninferiority threshold of a 5 percentage point difference in 24 month survival rates.|Hazard Ratio (HR)|1.26||||||95.0|1.26|1.75|||||This was a non-inferiority analysis, and so a one-sided 95% confidence interval was performed comparing the MVP arm to the VVI 40 arm.|The time from randomization to all cause mortality or last follow-up visit was determined for each subject. The null hypothesis was that the mortality hazard rate for patients with MVP programming was greater than that of patients with VVI40 programming.||1.75|1.26|
72329601|NCT00475085|144184788|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.013||||0.718|TWO_SIDED|95.0|-0.225|0.2||Response skewed. P-value determined after Box-Cox transformation (lambda=-1.6). Significance level set to 0.017 to account for three tested hypotheses.|ANOVA|Testing and estimation performed using contrasts in the context of an omnibus ANOVA.||Group 1 - Group 2 (palonosetron vs. granisetron)||0.200|-0.225|0.718
72329602|NCT00475085|144184788|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.195||||0.01|TWO_SIDED|95.0|-0.017|0.407||Response skewed. P-value determined after Box-Cox transformation (lambda=-1.6). Significance level set to 0.017 to account for three tested hypotheses.|ANOVA|Testing and estimation performed using contrasts in the context of an omnibus ANOVA.||Group 1 - Group 4 (adding dexamethasone)||0.407|-0.017|0.010
72329603|NCT00475085|144184788|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.025||||0.557|TWO_SIDED|95.0|-0.236|0.186||Response skewed. P-value determined after Box-Cox transformation (lambda=-1.6). Significance level set to 0.017 to account for three tested hypotheses.|ANOVA|Testing and estimation performed using contrasts in the context of an omnibus ANOVA.||Group 3 - Group 4 (aprepitant vs. prochlorperazine)||0.186|-0.236|0.557
72329604|NCT06899737|144184843|SUPERIORITY||Mean Difference (Final Values)|-2.55|STANDARD_ERROR_OF_MEAN|2.56||0.32|TWO_SIDED|95.0|-7.64|2.55|||t-test, 2 sided|||||2.55|-7.64|0.32
72329605|NCT06899737|144184844|SUPERIORITY||Mean Difference (Final Values)|4.18|STANDARD_ERROR_OF_MEAN|3.08||0.18|TWO_SIDED|95.0|-1.94|10.3|||t-test, 2 sided|||||10.30|-1.94|0.18
72329606|NCT06899737|144184845|SUPERIORITY||Mean Difference (Final Values)|0.18|STANDARD_ERROR_OF_MEAN|0.5||0.71|TWO_SIDED|95.0|-0.81|1.18|||t-test, 2 sided|||||1.18|-0.81|0.71
72329607|NCT06899737|144184846|SUPERIORITY||Mean Difference (Final Values)|0.61|STANDARD_ERROR_OF_MEAN|0.32||0.32|TWO_SIDED|95.0|-0.03|1.24|||t-test, 2 sided|||||1.24|-0.03|0.32
72329608|NCT06899737|144184847|SUPERIORITY||Median Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.44||0.91|TWO_SIDED|95.0|-0.82|0.92|||t-test, 2 sided|||||0.92|-0.82|0.91
72329609|NCT06899737|144184848|SUPERIORITY||Median Difference (Final Values)|0.69||||0.059|TWO_SIDED|95.0|-0.03|1.42|||t-test, 2 sided|||||1.42|-0.03|0.059
72329610|NCT06899737|144184849|SUPERIORITY||Median Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.41||0.79|TWO_SIDED|95.0|-0.92|0.71|||t-test, 2 sided|||||0.71|-0.92|0.79
72329611|NCT06899737|144184850|SUPERIORITY||Mean Difference (Final Values)|0.5|STANDARD_ERROR_OF_MEAN|0.33||0.14|TWO_SIDED|95.0|-0.16|1.15|||t-test, 2 sided|||||1.15|-0.16|0.14
72329612|NCT06899737|144184851|SUPERIORITY||Mean Difference (Final Values)|-0.34|STANDARD_ERROR_OF_MEAN|0.43||0.42|TWO_SIDED|95.0|-1.19|0.5|||t-test, 2 sided|||||0.50|-1.19|0.42
72329613|NCT06899737|144184852|SUPERIORITY||Mean Difference (Final Values)|0.33|STANDARD_ERROR_OF_MEAN|0.37||0.37|TWO_SIDED|95.0|-0.4|1.07|||t-test, 2 sided|||||1.07|-0.40|0.37
72329614|NCT06899737|144184854|SUPERIORITY||Mean Difference (Final Values)|6.72|STANDARD_ERROR_OF_MEAN|3.42||0.05|TWO_SIDED|95.0|-0.06|13.51|||t-test, 2 sided|||||13.51|-0.06|0.05
72329615|NCT06899737|144184855|SUPERIORITY||Mean Difference (Final Values)|0.42|STANDARD_ERROR_OF_MEAN|0.35||0.23|TWO_SIDED|95.0|-0.26|1.11|||t-test, 2 sided|||||1.11|-0.26|0.23
72329616|NCT06899737|144184856|SUPERIORITY||Mean Difference (Final Values)|0.65|STANDARD_ERROR_OF_MEAN|0.37||0.08|TWO_SIDED|95.0|-0.09|1.39|||t-test, 2 sided|||||1.39|-0.09|0.08
72329617|NCT06899737|144184857|SUPERIORITY||Mean Difference (Final Values)|0.59|STANDARD_ERROR_OF_MEAN|0.38||0.11|TWO_SIDED|95.0|-0.15|1.35|||t-test, 2 sided|||||1.35|-0.15|0.11
72329618|NCT06899737|144184858|SUPERIORITY||Mean Difference (Final Values)|0.67|STANDARD_ERROR_OF_MEAN|0.34||0.05|TWO_SIDED|95.0|-0.01|1.36|||t-test, 2 sided|||||1.36|-0.01|0.05
72329619|NCT00301262|144184890|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|18.13|STANDARD_ERROR_OF_MEAN|3.405|<|0.0001||95.0|11.4|24.86||Since there was only one primary endpoint no multiple comparison adjustments were made for primary analysis. Final stat. model included centre, treatment, smoking status and history of ED as factors, and age, duration of ED (baseline) as covariates.|ANCOVA||Mean difference between the sidenafil group compared to the placebo group was calculated along with 95% confidence intervals for these differences.|The primary analysis population was the FAS. The sample size was estimated based on an expected difference of 16.5 with a standard deviation of 28.4, based on previously observed data.||24.86|11.40|<0.0001
72329620|NCT00301262|144184891|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|5.09|STANDARD_DEVIATION|14.761||0.0028||95.0|1.8|8.37|||paired t-test||A paired t-test was used to examine the within treatment difference between week 8 and week 14 (open label phase).|||8.370|1.800|0.0028
72329621|NCT00301262|144184891|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|26.02|STANDARD_DEVIATION|22.294|<|0.0001||95.0|20.58|31.455|||paired t-test||A paired t-test was used to examine the within treatment difference between week 8 and week 14 (open label phase).|||31.455|20.580|<0.0001
72329622|NCT00301262|144184892|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.76|STANDARD_ERROR_OF_MEAN|0.656||0.008||95.0|0.47|3.06|||ANCOVA||Mean difference between the sidenafil group compared to the placebo group was calculated along with 95% confidence intervals for these differences.|||3.06|0.47|0.0080
72329623|NCT00301262|144184893|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.94|STANDARD_DEVIATION|2.909||0.0051||95.0|0.29|1.585|||paired t-test||A paired t-test was used to examine the within treatment difference between week 8 and week 14 (open label phase).|||1.585|0.290|0.0051
72329624|NCT00301262|144184893|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|2.79|STANDARD_DEVIATION|4.013|<|0.0001||95.0|1.812|3.77|||paired t-test||A paired t-test was used to examine the within treatment difference between week 8 and week 14 (open label phase).|||3.770|1.812|<0.0001
72329625|NCT00301262|144184894|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.61|STANDARD_ERROR_OF_MEAN|0.922||0.0054||95.0|0.78|4.43|||ANCOVA||Mean difference between the sidenafil group compared to the placebo group was calculated along with 95% confidence intervals for these differences.|||4.43|0.78|0.0054
72329626|NCT00301262|144184895|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.3|STANDARD_ERROR_OF_MEAN|0.368||0.4232||95.0|-0.43|1.02|||ANCOVA||Mean difference between the sidenafil group compared to the placebo group was calculated along with 95% confidence intervals for these differences.|||1.02|-0.43|0.4232
72329627|NCT00301262|144184896|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.68|STANDARD_ERROR_OF_MEAN|0.277||0.0156||95.0|0.13|1.22|||ANCOVA||Mean difference between the sidenafil group compared to the placebo group was calculated along with 95% confidence intervals for these differences.|||1.22|0.13|0.0156
72329628|NCT00301262|144184897|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.2|STANDARD_ERROR_OF_MEAN|0.458||0.0096||95.0|0.3|2.11|||ANCOVA||Mean difference between the sidenafil group compared to the placebo group was calculated along with 95% confidence intervals for these differences.|||2.11|0.30|0.0096
72329629|NCT00301262|144184898|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.9|STANDARD_ERROR_OF_MEAN|0.359||0.0135||95.0|0.19|1.61|||ANCOVA||Mean difference between the sidenafil group compared to the placebo group was calculated along with 95% confidence intervals for these differences.|||1.61|0.19|0.0135
72329630|NCT00301262|144184899|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|1.49|STANDARD_DEVIATION|4.392||0.0033||95.0|0.051|2.465|||paired t-test||A paired t-test was used to examine the within treatment difference between week 8 and week 14 (open label phase).|||2.465|0.0510|0.0033
72329631|NCT00301262|144184899|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|5.22|STANDARD_DEVIATION|6.346|<|0.0001||95.0|3.676|6.772|||paired t-test||A paired t-test was used to examine the within treatment difference between week 8 and week 14 (open label phase).|||6.772|3.676|<0.0001
72329632|NCT00301262|144184900|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.2|STANDARD_DEVIATION|1.57||0.2581||95.0|-0.149|0.549|||paired t-test||A paired t-test was used to examine the within treatment difference between week 8 and week 14 (open label phase).|||0.549|-0.149|0.2581
72329633|NCT00301262|144184900|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|1.39|STANDARD_DEVIATION|2.582|<|0.0001||95.0|0.758|2.018|||paired t-test||A paired t-test was used to examine the within treatment difference between week 8 and week 14 (open label phase).|||2.018|0.758|<0.0001
72329634|NCT00301262|144184901|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.18|STANDARD_DEVIATION|1.456||0.2857||95.0|-0.149|0.499|||paired t-test||A paired t-test was used to examine the within treatment difference between week 8 and week 14 (open label phase).|||0.499|-0.149|0.2857
72329635|NCT00301262|144184901|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.76|STANDARD_DEVIATION|1.706||0.0005||95.0|0.345|1.177|||paired t-test||A paired t-test was used to examine the within treatment difference between week 8 and week 14 (open label phase).|||1.177|0.345|0.0005
72329636|NCT00301262|144184902|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.75|STANDARD_DEVIATION|2.548||0.0102||95.0|0.183|1.317|||paired t-test||A paired t-test was used to examine the within treatment difference between week 8 and week 14 (open label phase).|||1.317|0.183|0.0102
72329637|NCT00301262|144184902|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|2.28|STANDARD_DEVIATION|2.979|<|0.0001||95.0|1.557|3.01|||paired t-test||A paired t-test was used to examine the within treatment difference between week 8 and week 14 (open label phase).|||3.010|1.557|<0.0001
72329638|NCT00301262|144184903|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.68|STANDARD_DEVIATION|1.847||0.0016||95.0|0.264|1.086|||paired t-test||A paired t-test was used to examine the within treatment difference between week 8 and week 14 (open label phase).|||1.086|0.264|0.0016
72329639|NCT00301262|144184903|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|1.9|STANDARD_DEVIATION|2.297|<|0.0001||95.0|1.335|2.456|||paired t-test||A paired t-test was used to examine the within treatment difference between week 8 and week 14 (open label phase).|||2.456|1.335|<0.0001
72329640|NCT00301262|144184904|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.78|STANDARD_ERROR_OF_MEAN|1.038||0.0083||95.0|0.73|4.83|||ANCOVA||Mean difference between the sidenafil group compared to the placebo group was calculated along with 95% confidence intervals for these differences.|||4.83|0.73|0.0083
72329641|NCT00301262|144184905|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.06|STANDARD_DEVIATION|5.193||0.9146||95.0|-1.218|1.093|||paired t-test||A paired t-test was used to examine the within treatment difference between week 8 and week 14 (open label phase).|||1.093|-1.218|0.9146
72329642|NCT00301262|144184905|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|5.54|STANDARD_DEVIATION|6.463|<|0.0001||95.0|3.961|7.114|||paired t-test||A paired t-test was used to examine the within treatment difference between week 8 and week 14 (open label phase).|||7.114|3.961|<0.0001
72329643|NCT00301262|144184906|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|18.42|STANDARD_ERROR_OF_MEAN|4.826||0.0002||95.0|8.88|27.96|||ANCOVA||Mean difference between the sidenafil group compared to the placebo group was calculated along with 95% confidence intervals for these differences.|||27.96|8.88|0.0002
72329644|NCT00301262|144184907|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|6.41|STANDARD_DEVIATION|20.444||0.0064||95.0|1.857|10.956|||paired t-test||A paired t-test was used to examine the within treatment difference between week 8 and week 14 (open label phase).|||10.956|1.857|0.0064
72329645|NCT00301262|144184907|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|26.8|STANDARD_DEVIATION|29.384|<|0.0001|TWO_SIDED|95.0|19.636|33.971|||paired t-test||A paired t-test was used to examine the within treatment difference between week 8 and week 14 (open label phase).|||33.971|19.636|<0.0001
72329646|NCT00301262|144184908|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|6.491||||0.0001||95.0|3.042|13.851|||Regression, Logistic|||||13.851|3.042|0.0001
72329647|NCT00301262|144184909|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|4.915|||<|0.0001||95.0|2.396|10.08|||Regression, Logistic|||||10.080|2.396|<0.0001
72329648|NCT00301262|144184910|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|3.676||||0.0187||95.0|1.242|10.875|||Regression, Logistic|||||10.875|1.242|0.0187
72329649|NCT00301262|144184911|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|13.9|STANDARD_ERROR_OF_MEAN|4.716||0.0037||95.0|4.59|23.22|||independent-samples t-test||Independent-samples t-test was used to test mean difference of zero between treatment groups (Viagra - Placebo) at each visit interval.|||23.22|4.59|0.0037
72329650|NCT00301262|144184912|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|9.72|STANDARD_ERROR_OF_MEAN|4.496||0.0321||95.0|0.84|18.6|||independent-samples t-test||Mean Difference = Week 8 - Baseline|||18.60|0.84|0.0321
72329651|NCT00301262|144184913|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-7.97|STANDARD_ERROR_OF_MEAN|3.901||0.0427||95.0|-15.68|-0.27|||independent-samples t-test||Independent-samples t-test was used to test mean difference of zero between treatment groups (Viagra - Placebo) at each visit interval.|||-0.27|-15.68|0.0427
72329652|NCT00301262|144184914|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-7.6|STANDARD_ERROR_OF_MEAN|3.903||0.0533||95.0|-15.32|0.11|||independent-samples t-test||Independent-samples t-test was used to test mean difference of zero between treatment groups (Viagra - Placebo) at each visit interval.|||0.11|-15.32|0.0533
72329653|NCT00301262|144184915|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|1.167|STANDARD_ERROR_OF_MEAN|0.3041||0.0002||95.0|0.566|1.768|||2-sample independent t-test||A 2-sample independent t-test was used to test the difference between treatment for the change between baseline and Week 8 (change = Week 8 - baseline).|||1.768|0.566|0.0002
72329654|NCT00301262|144184916|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|1.4454|STANDARD_ERROR_OF_MEAN|0.3638||0.0001||95.0|0.727|2.164|||2-sample independent t-test||A 2-sample independent t-test was used to test the difference between treatment for the change between baseline and Week 8 (change = Week 8 - baseline).|||2.164|0.727|0.0001
72329655|NCT00301262|144184917|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|1.1821|STANDARD_ERROR_OF_MEAN|0.3946||0.0032||95.0|0.403|1.961|||2-sample independent t-test||A 2-sample independent t-test was used to test the difference between treatment for the change between baseline and Week 8 (change = Week 8 - baseline).|||1.961|0.403|0.0032
72329656|NCT00301262|144184918|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|1.2123|STANDARD_ERROR_OF_MEAN|0.3549||0.0008||95.0|0.511|1.913|||2-sample independent t-test||A 2-sample independent t-test was used to test the difference between treatment for the change between baseline and Week 8 (change = Week 8 - baseline).|||1.913|0.511|0.0008
72329657|NCT00301262|144184919|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.39|STANDARD_DEVIATION|1.454||0.0195||95.0|0.064|0.711|||paired t-test||A paired t-test was used to examine the within treatment difference between week 8 and week 14 (open label phase).|||0.711|0.064|0.0195
72329658|NCT00301262|144184919|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|2.09|STANDARD_DEVIATION|2.207|<|0.0001||95.0|1.551|2.628|||paired t-test||A paired t-test was used to examine the within treatment difference between week 8 and week 14 (open label phase).|||2.628|1.551|<0.0001
72329659|NCT00301262|144184920|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.4|STANDARD_DEVIATION|1.489||0.0186||95.0|0.069|0.731|||paired t-test||A paired t-test was used to examine the within treatment difference between week 8 and week 14 (open label phase).|||0.731|0.069|0.0186
72329660|NCT00301262|144184920|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|2.67|STANDARD_DEVIATION|2.573|<|0.0001||95.0|2.044|3.299|||paired t-test||A paired t-test was used to examine the within treatment difference between week 8 and week 14 (open label phase).|||3.299|2.044|<0.0001
72329661|NCT00301262|144184921|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.65|STANDARD_DEVIATION|1.917||0.0033||95.0|0.223|1.077|||paired t-test||A paired t-test was used to examine the within treatment difference between week 8 and week 14 (open label phase).|||1.077|0.223|0.0033
72329662|NCT00301262|144184921|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|2.61|STANDARD_DEVIATION|2.335|<|0.0001||95.0|2.042|3.182|||paired t-test||A paired t-test was used to examine the within treatment difference between week 8 and week 14 (open label phase).|||3.182|2.042|<0.0001
72329663|NCT00301262|144184922|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.45|STANDARD_DEVIATION|1.606||0.0143||95.0|0.093|0.807|||paired t-test||A paired t-test was used to examine the within treatment difference between week 8 and week 14 (open label phase).|||0.807|0.093|0.0143
72329664|NCT00301262|144184922|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|1.99|STANDARD_DEVIATION|2.178|<|0.0001||95.0|1.454|2.516|||paired t-test||A paired t-test was used to examine the within treatment difference between week 8 and week 14 (open label phase).|||2.516|1.454|<0.0001
72329665|NCT00301262|144184923|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0325||95.0|||||McNemar|||Exact p-values calculated using McNemar's test for difference between Week 8 and Week 14.||||0.0325
72329666|NCT00301262|144184923|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||McNemar|||Exact p-values calculated using McNemar's test for difference between Week 8 and Week 14.||||<0.0001
72329667|NCT00301262|144184924|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0196||95.0|||||McNemar|||Exact p-values calculated using McNemar's test for difference between Week 8 and Week 14.||||0.0196
72329668|NCT00301262|144184924|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||McNemar|||Exact p-values calculated using McNemar's test for difference between Week 8 and Week 14.||||<0.0001
72329669|NCT00301262|144184925|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3173||95.0|||||McNemar|||Exact p-values calculated using McNemar's test for difference between Week 8 and Week 14.||||0.3173
72329670|NCT00301262|144184925|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0016||95.0|||||McNemar|||Exact p-values calculated using McNemar's test for difference between Week 8 and Week 14.||||0.0016
72329671|NCT00301262|144184926|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-5.55|STANDARD_ERROR_OF_MEAN|2.958||0.0624||95.0|-11.39|0.29|||Independent-samples t-test||Independent-samples t-test was used to test mean difference of zero between treatment groups (Viagra - Placebo) at each visit interval.|||0.29|-11.39|0.0624
72329672|NCT00301262|144184926|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|1.38|STANDARD_ERROR_OF_MEAN|1.835||0.4523||95.0|-2.24|5.01|||Independent-samples t-test||Independent-samples t-test was used to test mean difference of zero between treatment groups (Viagra - Placebo) at each visit interval.|||5.01|-2.24|0.4523
72329673|NCT00301262|144184927|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-2.48|STANDARD_ERROR_OF_MEAN|1.962||0.2081||95.0|-6.35|1.4|||Independent-samples t-test||Independent-samples t-test was used to test mean difference of zero between treatment groups (Viagra - Placebo) at each visit interval.|||1.40|-6.35|0.2081
72329674|NCT00301262|144184927|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|1.61|STANDARD_ERROR_OF_MEAN|1.958||0.4131||95.0|-2.26|5.48|||Independent-samples t-test||Independent-samples t-test was used to test mean difference of zero between treatment groups (Viagra - Placebo) at each visit interval.|||5.48|-2.26|0.4131
72329675|NCT00301262|144184928|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-1.77|STANDARD_ERROR_OF_MEAN|2.126||0.4069||95.0|-5.97|2.43|||Independent-samples t-test||Independent-samples t-test was used to test mean difference of zero between treatment groups (Viagra - Placebo) at each visit interval.|||2.43|-5.97|0.4069
72329676|NCT00301262|144184928|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|2.37|STANDARD_ERROR_OF_MEAN|1.489||0.1137||95.0|-0.57|5.31|||Independent-samples t-test||Independent-samples t-test was used to test mean difference of zero between treatment groups (Viagra - Placebo) at each visit interval.|||5.31|-0.57|0.1137
72329677|NCT00301262|144184929|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-12.23|STANDARD_ERROR_OF_MEAN|4.829||0.0123||95.0|-21.77|-2.7|||Independent-samples t-test||Independent-samples t-test was used to test mean difference of zero between treatment groups (Viagra - Placebo) at each visit interval.|||-2.70|-21.77|0.0123
72329678|NCT00301262|144184929|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.62|STANDARD_ERROR_OF_MEAN|4.883||0.8993||95.0|-10.27|9.03|||Independent-samples t-test||Independent-samples t-test was used to test mean difference of zero between treatment groups (Viagra - Placebo) at each visit interval.|||9.03|-10.27|0.8993
72329679|NCT00301262|144184930|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|22.03|STANDARD_ERROR_OF_MEAN|5.458|<|0.0001||95.0|11.25|32.81|||Independent-samples t-test||Independent-samples t-test was used to test mean difference of zero between treatment groups (Viagra - Placebo) at each visit interval.|||32.81|11.25|<0.0001
72329680|NCT00301262|144184930|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-4.74|STANDARD_ERROR_OF_MEAN|5.818||0.4165||95.0|-16.24|6.76|||Independent-samples t-test||Independent-samples t-test was used to test mean difference of zero between treatment groups (Viagra - Placebo) at each visit interval.|||6.76|-16.24|0.4165
72329681|NCT00301262|144184931|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|9.8|STANDARD_ERROR_OF_MEAN|4.351||0.0257||95.0|1.21|18.39|||Independent-samples t-test||Independent-samples t-test was used to test mean difference of zero between treatment groups (Viagra - Placebo) at each visit interval.|||18.39|1.21|0.0257
72329682|NCT00301262|144184931|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-5.36|STANDARD_ERROR_OF_MEAN|3.209||0.0971||95.0|-11.7|0.98|||Independent-samples t-test||Independent-samples t-test was used to test mean difference of zero between treatment groups (Viagra - Placebo) at each visit interval.|||0.98|-11.70|0.0971
72329683|NCT00301262|144184932|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-3.18|STANDARD_ERROR_OF_MEAN|1.754||0.0726||95.0|-6.66|0.3|||Independent-samples t-test||Independent-samples t-test was used to test mean difference of zero between treatment groups (Viagra - Placebo) at each visit interval.|||0.30|-6.66|0.0726
72329684|NCT00301262|144184932|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-2.04|STANDARD_ERROR_OF_MEAN|1.798||0.2581||95.0|-5.61|1.52|||Independent-samples t-test||Independent-samples t-test was used to test mean difference of zero between treatment groups (Viagra - Placebo) at each visit interval.|||1.52|-5.61|0.2581
72329685|NCT00301262|144184933|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-1.04|STANDARD_ERROR_OF_MEAN|4.45||0.8158||95.0|-9.86|7.78|||Independent-samples t-test||Independent-samples t-test was used to test mean difference of zero between treatment groups (Viagra - Placebo) at each visit interval.|||7.78|-9.86|0.8158
72329686|NCT00301262|144184933|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.33|STANDARD_ERROR_OF_MEAN|1.692||0.8464||95.0|-3.68|3.02|||Independent-samples t-test||Independent-samples t-test was used to test mean difference of zero between treatment groups (Viagra - Placebo) at each visit interval.|||3.02|-3.68|0.8464
72329687|NCT00301262|144184934|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.34|STANDARD_ERROR_OF_MEAN|5.789||0.9529||95.0|-11.82|11.13|||Independent-samples t-test||Independent-samples t-test was used to test mean difference of zero between treatment groups (Viagra - Placebo) at each visit interval.|||11.13|-11.82|0.9529
72329688|NCT00301262|144184934|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.69|STANDARD_ERROR_OF_MEAN|4.994||0.8899||95.0|-10.59|9.2|||Independent-samples t-test||Independent-samples t-test was used to test mean difference of zero between treatment groups (Viagra - Placebo) at each visit interval.|||9.20|-10.59|0.8899
72329689|NCT00301262|144184935|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-10.18|STANDARD_ERROR_OF_MEAN|7.897||0.2001||95.0|-25.83|5.47|||Independent-samples t-test||Independent-samples t-test was used to test mean difference of zero between treatment groups (Viagra - Placebo) at each visit interval.|||5.47|-25.83|0.2001
72329690|NCT00301262|144184935|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|9.68|STANDARD_ERROR_OF_MEAN|6.724||0.1527||95.0|-3.64|23.01|||Independent-samples t-test||Independent-samples t-test was used to test mean difference of zero between treatment groups (Viagra - Placebo) at each visit interval.|||23.01|-3.64|0.1527
72329691|NCT00301262|144184936|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|14.74|STANDARD_ERROR_OF_MEAN|7.774||0.0606||95.0|-0.67|30.15|||Independent-samples t-test||Independent-samples t-test was used to test mean difference of zero between treatment groups (Viagra - Placebo) at each visit interval.|||30.15|-0.67|0.0606
72329692|NCT00301262|144184936|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-6.62|STANDARD_ERROR_OF_MEAN|7.318||0.3678||95.0|-21.12|7.88|||Independent-samples t-test||Independent-samples t-test was used to test mean difference of zero between treatment groups (Viagra - Placebo) at each visit interval.|||7.88|-21.12|0.3678
72329693|NCT00301262|144184937|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|4.56|STANDARD_ERROR_OF_MEAN|7.474||0.5429||95.0|-10.25|19.37|||Independent-samples t-test||Independent-samples t-test was used to test mean difference of zero between treatment groups (Viagra - Placebo) at each visit interval.|||19.37|-10.25|0.5429
72329694|NCT00301262|144184937|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|3.07|STANDARD_ERROR_OF_MEAN|5.595||0.5849||95.0|-8.02|14.15|||Independent-samples t-test||Independent-samples t-test was used to test mean difference of zero between treatment groups (Viagra - Placebo) at each visit interval.|||14.15|-8.02|0.5849
72329695|NCT00301262|144184938|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|18.86|STANDARD_ERROR_OF_MEAN|4.952||0.0002||95.0|9.08|28.64|||Independent-samples t-test||Independent-samples t-test was used to test mean difference of zero between treatment groups (Viagra - Placebo) at each visit interval.|||28.64|9.08|0.0002
72329696|NCT00301262|144184938|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|4.93|STANDARD_ERROR_OF_MEAN|6.212||0.429||95.0|-7.35|17.2|||Independent-samples t-test||Independent-samples t-test was used to test mean difference of zero between treatment groups (Viagra - Placebo) at each visit interval.|||17.20|-7.35|0.4290
72329697|NCT00368745|144184939|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2838||95.0||||significance determined using 2-tailed significance level of 0.05|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) with country as a covariate||Primary objective: evaluate the efficacy of pregabalin in maintaining the benzodiazepine free state in subjects with prior stable alprazolam use.||||0.2838
72329698|NCT00368745|144184940|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.48|STANDARD_ERROR_OF_MEAN|0.81||0.0709||95.0|-3.1|0.13||contrasts performed using Dunnett's Test|ANCOVA|Least squares (LS) Means from the ANCOVA model with treatment as the main effect and country and baseline as covariate||Alprazolam Taper (AT) Week 1||0.13|-3.10|0.0709
72329699|NCT00368745|144184940|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.89|STANDARD_ERROR_OF_MEAN|1.08||0.0006||95.0|-6.04|-1.74||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country and baseline as covariate||AT Week 2||-1.74|-6.04|0.0006
72329700|NCT00368745|144184940|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.38|STANDARD_ERROR_OF_MEAN|1.3||0.0718||95.0|-4.98|0.22||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country and baseline as covariate||AT Week 3||0.22|-4.98|0.0718
72329701|NCT00368745|144184940|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.38|STANDARD_ERROR_OF_MEAN|1.92||0.092||95.0|-7.37|0.6||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country and baseline as covariate||AT Week 4||0.60|-7.37|0.0920
72329702|NCT00368745|144184940|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.22|STANDARD_ERROR_OF_MEAN|3.04||0.1371||95.0|-12.67|2.23||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country and baseline as covariate||AT week 5||2.23|-12.67|0.1371
72329703|NCT00368745|144184940|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.68|STANDARD_ERROR_OF_MEAN|2.04||0.0882||95.0|-7.96|0.61||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country and baseline as covariate||AT Week 6||0.61|-7.96|0.0882
72329704|NCT00368745|144184940|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.83|STANDARD_ERROR_OF_MEAN|1.11||0.0135||95.0|-5.05|-0.61||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country and baseline as covariate||Alprazolam Free (AF) Week 1||-0.61|-5.05|0.0135
72329705|NCT00368745|144184940|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.01|STANDARD_ERROR_OF_MEAN|1.18||0.3924||95.0|-3.38|1.35||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country and baseline as covariate||AF Week 2||1.35|-3.38|0.3924
72329706|NCT00368745|144184940|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.0|STANDARD_ERROR_OF_MEAN|1.14||0.3868||95.0|-3.29|1.3||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country and baseline as covariate||AF Week 3||1.30|-3.29|0.3868
72329707|NCT00368745|144184940|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|1.15||0.9966||95.0|-2.31|2.32||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country and baseline as covariate||AF Week 4||2.32|-2.31|0.9966
72329708|NCT00368745|144184940|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.51|STANDARD_ERROR_OF_MEAN|1.26||0.6873||95.0|-3.07|2.05||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country and baseline as covariate||AF Week 5||2.05|-3.07|0.6873
72329709|NCT00368745|144184940|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.85|STANDARD_ERROR_OF_MEAN|1.35||0.5337||95.0|-3.62|1.91||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country and baseline as covariate||AF Week 6||1.91|-3.62|0.5337
72329710|NCT00368745|144184940|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.79|STANDARD_ERROR_OF_MEAN|1.37||0.0008||95.0|-7.51|-2.07||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country and baseline as covariate||Endpoint \[LOCF\]||-2.07|-7.51|0.0008
72329711|NCT00368745|144184943|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.18|STANDARD_ERROR_OF_MEAN|1.4||0.122||95.0|-4.97|0.6||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country as covariate||Alprazolam Taper (AT) Week 1||0.60|-4.97|0.1220
72329712|NCT00368745|144184943|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.63|STANDARD_ERROR_OF_MEAN|1.26||0.0053||95.0|-6.15|-1.11||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country as covariate||AT Week 2||-1.11|-6.15|0.0053
72329713|NCT00368745|144184943|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.85|STANDARD_ERROR_OF_MEAN|1.73||0.1048||95.0|-6.32|0.62||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country as covariate||AT Week 3||0.62|-6.32|0.1048
72329714|NCT00368745|144184943|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.41|STANDARD_ERROR_OF_MEAN|1.52||0.0357||95.0|-6.57|-0.25||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country as covariate||AT Week 4||-0.25|-6.57|0.0357
72329715|NCT00368745|144184943|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.28|STANDARD_ERROR_OF_MEAN|2.67||0.4263||95.0|-8.82|4.26||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country as covariate||AT Week 5||4.26|-8.82|0.4263
72329716|NCT00368745|144184943|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.73|STANDARD_ERROR_OF_MEAN|2.02||0.0104||95.0|-9.96|-1.51||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country as covariate||AT Week 6||-1.51|-9.96|0.0104
72329717|NCT00368745|144184943|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.92|STANDARD_ERROR_OF_MEAN|1.4||0.0069||95.0|-6.73|-1.12||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country as covariate||Alprazolam Free (AF) Week 1||-1.12|-6.73|0.0069
72329718|NCT00368745|144184943|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.71|STANDARD_ERROR_OF_MEAN|1.37||0.2185||95.0|-4.47|1.05||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country as covariate||AF Week 2||1.05|-4.47|0.2185
72329719|NCT00368745|144184943|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.29|STANDARD_ERROR_OF_MEAN|1.06||0.7832||95.0|-2.41|1.83||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country as covariate||AF Week 3||1.83|-2.41|0.7832
72329720|NCT00368745|144184943|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.44|STANDARD_ERROR_OF_MEAN|1.16||0.7062||95.0|-1.9|2.79||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country as covariate||AF Week 4||2.79|-1.90|0.7062
72329721|NCT00368745|144184943|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.38|STANDARD_ERROR_OF_MEAN|1.04||0.7161||95.0|-2.49|1.73||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country as covariate||AF Week 5||1.73|-2.49|0.7161
72329722|NCT00368745|144184943|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.11|STANDARD_ERROR_OF_MEAN|1.43||0.0376||95.0|-6.03|-0.19||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country as covariate||AF Week 6||-0.19|-6.03|0.0376
72329723|NCT00368745|144184943|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.8|STANDARD_ERROR_OF_MEAN|1.48||0.0122||95.0|-6.74|-0.85||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country as covariate||Endpoint \[LOCF\]||-0.85|-6.74|0.0122
72329724|NCT00368745|144184945|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.45|STANDARD_ERROR_OF_MEAN|0.16||0.0052||95.0|-0.76|-0.14||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country and baseline as covariate||Alprazolam Taper (AT) Week 1||-0.14|-0.76|0.0052
72329725|NCT00368745|144184945|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.74|STANDARD_ERROR_OF_MEAN|0.18||0.0001||95.0|-1.11|-0.38||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country and baseline as covariate||AT Week 2||-0.38|-1.11|0.0001
72329726|NCT00368745|144184945|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|0.25||0.0528||95.0|-1.0|0.01||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country and baseline as covariate||AT Week 3||0.01|-1.00|0.0528
72329727|NCT00368745|144184945|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.37|STANDARD_ERROR_OF_MEAN|0.35||0.3085||95.0|-1.11|0.37||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country and baseline as covariate||AT Week 4||0.37|-1.11|0.3085
72329728|NCT00368745|144184945|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.72|STANDARD_ERROR_OF_MEAN|0.47||0.1807||95.0|-1.92|0.47||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country and baseline as covariate||AT Week 5||0.47|-1.92|0.1807
72329729|NCT00368745|144184945|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.71|STANDARD_ERROR_OF_MEAN|0.42||0.1074||95.0|-1.58|0.17||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country and baseline as covariate||AT Week 6||0.17|-1.58|0.1074
72329730|NCT00368745|144184945|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.69|STANDARD_ERROR_OF_MEAN|0.2||0.0013||95.0|-1.1|-0.28||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country and baseline as covariate||Alprazolam Free (AF) Week 1||-0.28|-1.10|0.0013
72329731|NCT00368745|144184945|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|0.25||0.0503||95.0|-0.99|0.0||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country and baseline as covariate||AF Week 2||0.00|-0.99|0.0503
72329732|NCT00368745|144184945|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.56|STANDARD_ERROR_OF_MEAN|0.26||0.0364||95.0|-1.09|-0.04||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country and baseline as covariate||AF Week 3||-0.04|-1.09|0.0364
72329733|NCT00368745|144184945|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.03|STANDARD_ERROR_OF_MEAN|0.24||0.914||95.0|-0.51|0.46||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country and baseline as covariate||AF Week 4||0.46|-0.51|0.9140
72329734|NCT00368745|144184945|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.08|STANDARD_ERROR_OF_MEAN|0.27||0.7789||95.0|-0.62|0.47||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country and baseline as covariate||AF Week 5||0.47|-0.62|0.7789
72329735|NCT00368745|144184945|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.32|STANDARD_ERROR_OF_MEAN|0.31||0.3189||95.0|-0.95|0.32||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country and baseline as covariate||AF Week 6||0.32|-0.95|0.3189
72329736|NCT00368745|144184945|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.76|STANDARD_ERROR_OF_MEAN|0.25||0.0031||95.0|-1.26|-0.27||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country and baseline as covariate||Endpoint \[LOCF\]||-0.27|-1.26|0.0031
72329737|NCT00368745|144184946|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.37|STANDARD_ERROR_OF_MEAN|0.24||0.126||95.0|-0.86|0.11||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country as covariate||Alprazolam Taper (AT) Week 1||0.11|-0.86|0.1260
72329738|NCT00368745|144184946|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.81|STANDARD_ERROR_OF_MEAN|0.29||0.0074||95.0|-1.4|-0.22||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country as covariate||AT Week 2||-0.22|-1.40|0.0074
72329739|NCT00368745|144184946|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.59|STANDARD_ERROR_OF_MEAN|0.38||0.125||95.0|-1.35|0.17||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country as covariate||AT Week 3||0.17|-1.35|0.1250
72329740|NCT00368745|144184946|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.08|STANDARD_ERROR_OF_MEAN|0.6||0.8991||95.0|-1.17|1.32||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country as covariate||AT Week 4||1.32|-1.17|0.8991
72329741|NCT00368745|144184946|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.81|STANDARD_ERROR_OF_MEAN|0.53||0.1747||95.0|-2.07|0.46||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country as covariate||AT Week 5||0.46|-2.07|0.1747
72329742|NCT00368745|144184946|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.85|STANDARD_ERROR_OF_MEAN|0.45||0.0744||95.0|-1.79|0.09||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country as covariate||AT Week 6||0.09|-1.79|0.0744
72329743|NCT00368745|144184946|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.98|STANDARD_ERROR_OF_MEAN|0.35||0.0063||95.0|-1.67|-0.29||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country as covariate||Alprazolam Free (AF) Week 1||-0.29|-1.67|0.0063
72329744|NCT00368745|144184946|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.87|STANDARD_ERROR_OF_MEAN|0.34||0.014||95.0|-1.56|-0.18||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country as covariate||AF Week 2||-0.18|-1.56|0.0140
72329745|NCT00368745|144184946|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.78|STANDARD_ERROR_OF_MEAN|0.34||0.0267||95.0|-1.46|-0.09||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country as covariate||AF Week 3||-0.09|-1.46|0.0267
72329746|NCT00368745|144184946|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.26|STANDARD_ERROR_OF_MEAN|0.38||0.5104||95.0|-1.03|0.52||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country as covariate||AF Week 4||0.52|-1.03|0.5104
72329747|NCT00368745|144184946|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.48|STANDARD_ERROR_OF_MEAN|0.43||0.2702||95.0|-1.35|0.39||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country as covariate||AF Week 5||0.39|-1.35|0.2702
72329748|NCT00368745|144184946|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.66|STANDARD_ERROR_OF_MEAN|0.42||0.1241||95.0|-1.52|0.19||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country as covariate||AF Week 6||0.19|-1.52|0.1241
72329749|NCT00368745|144184946|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.95|STANDARD_ERROR_OF_MEAN|0.36||0.0109||95.0|-1.67|-0.22||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country as covariate||Endpoint \[LOCF\]||-0.22|-1.67|0.0109
72329750|NCT00368745|144184947|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.66|STANDARD_ERROR_OF_MEAN|0.28||0.0226||95.0|-1.22|-0.09||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country as covariate||Alprazolam Taper (AT) Week 1||-0.09|-1.22|0.0226
72329751|NCT00368745|144184947|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.9|STANDARD_ERROR_OF_MEAN|0.34||0.0099||95.0|-1.58|-0.22||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country as covariate||AT Week 2||-0.22|-1.58|0.0099
72329752|NCT00368745|144184947|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.38|STANDARD_ERROR_OF_MEAN|0.35||0.2827||95.0|-1.07|0.32||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country as covariate||AT Week 3||0.32|-1.07|0.2827
72329753|NCT00368745|144184947|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.13|STANDARD_ERROR_OF_MEAN|0.58||0.8232||95.0|-1.07|1.34||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country as covariate||AT Week 4||1.34|-1.07|0.8232
72329754|NCT00368745|144184947|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.85|STANDARD_ERROR_OF_MEAN|0.66||0.2409||95.0|-2.41|0.72||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country as covariate||AT Week 5||0.72|-2.41|0.2409
72329755|NCT00368745|144184947|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.45|STANDARD_ERROR_OF_MEAN|0.61||0.476||95.0|-1.73|0.84||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country as covariate||AT Week 6||0.84|-1.73|0.4760
72329756|NCT00368745|144184947|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|0.32||0.1252||95.0|-1.14|0.14||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country as covariate||Alprazolam Free (AF) Week 1||0.14|-1.14|0.1252
72329757|NCT00368745|144184947|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.33||0.0717||95.0|-1.26|0.06||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country as covariate||AF Week 2||0.06|-1.26|0.0717
72329758|NCT00368745|144184947|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.64|STANDARD_ERROR_OF_MEAN|0.35||0.0707||95.0|-1.33|0.06||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country as covariate||AF Week 3||0.06|-1.33|0.0707
72329759|NCT00368745|144184947|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.39||0.4341||95.0|-1.08|0.47||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country as covariate||AF Week 4||0.47|-1.08|0.4341
72329760|NCT00368745|144184947|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.38|STANDARD_ERROR_OF_MEAN|0.42||0.37||95.0|-1.23|0.47||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country as covariate||AF Week 5||0.47|-1.23|0.3700
72329761|NCT00368745|144184947|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.96|STANDARD_ERROR_OF_MEAN|0.43||0.0328||95.0|-1.83|-0.08||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country as covariate||AF Week 6||-0.08|-1.83|0.0328
72329762|NCT00368745|144184947|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.03|STANDARD_ERROR_OF_MEAN|0.39||0.0096||95.0|-1.8|-0.26||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country as covariate||Endpoint \[LOCF\]||-0.26|-1.80|0.0096
72329763|NCT00368745|144184948|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.37|STANDARD_ERROR_OF_MEAN|2.68||0.8897||95.0|-5.74|4.99||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country and baseline as the covariate||||4.99|-5.74|0.8897
72329764|NCT00368745|144184949|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0626||95.0||||p-value is from the log-rank statistic from the tests for equality over treatment as strata and country used as covariate|Log Rank|||||||0.0626
72329765|NCT00368745|144184950|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0148||95.0||||p-value is from the log-rank statistic from the tests for equality over treatment as strata and country used as covariate|Log Rank|||||||0.0148
72329766|NCT00368745|144184951|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1159||95.0||||p-value is obtained using Cochran-Mantel-Haenszel option|Cochran-Mantel-Haenszel|||||||0.1159
72329767|NCT00501592|144184952|SUPERIORITY_OR_OTHER|||||||0.04|||||||t-test, 2 sided|||The primary endpoints are calculated as the change (post minus pre treatment) during low dose and high dose insulin infusion periods. These are compared between placebo and INT-747 25 mg using t-tests for independent samples. These tests will be made without correction for multiple comparisons using 0.05 as the alpha criterion for significance. Results will be described with the corresponding means and standard deviations.||||0.040
72329768|NCT00501592|144184952|SUPERIORITY_OR_OTHER|||||||0.28|||||||t-test, 2 sided|||The primary endpoints are calculated as the change (post minus pre treatment) during low dose and high dose insulin infusion periods. These are compared between placebo and INT-747 50 mg using t-tests for independent samples. These tests will be made without correction for multiple comparisons using 0.05 as the alpha criterion for significance. Results will be described with the corresponding means and standard deviations.||||0.28
72329769|NCT00501592|144184953|SUPERIORITY_OR_OTHER|||||||0.0031||95.0|||||t-test, 2 sided|||||||0.0031
72329770|NCT00501592|144184953|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||t-test, 2 sided|||||||>0.05
72329771|NCT00501592|144184953|SUPERIORITY_OR_OTHER|||||||0.0001||95.0|||||t-test, 2 sided|||||||0.0001
72329772|NCT00501592|144184953|SUPERIORITY_OR_OTHER|||||||0.0005||95.0|||||t-test, 2 sided|||||||0.0005
72329773|NCT01525862|144184956|SUPERIORITY||||||<|0.0001||||||P values \<0.05 are considered statistically significant.|t-test, 2 sided|||||||<0.0001
72329774|NCT00282087|144185001|SUPERIORITY_OR_OTHER||Two year PFS|78.0||||0.15|TWO_SIDED|95.0|67.0|91.0|||Bayesian Posterior Probability|||The primary endpoint is progression-free survival time, with progression defined as a patient having evidence of recurrent LMS on follow-up evaluation and CT scan. Futility monitoring will be based on the accumulating right-censored PFS time data. The monitoring rules will be based on a Bayesian model.||91|67|0.15
72329775|NCT00282087|144185003|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|-0.00269|||||TWO_SIDED||||||Cox Proportional Hazards|||Age correlation with progression-free survival for patients on study treatment.||||
72329776|NCT00282087|144185004|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.02|||||TWO_SIDED||||||Cox Proportional Hazards|||Menopausal status at diagnosis correlation with progression-free survival for patients on study treatment.||||
72329777|NCT00282087|144185005|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.101|||||TWO_SIDED||||||Cox Proportional Hazards|||Uterine serosal involvement correlation with progression-free survival for patients on study treatment.||||
72329778|NCT00282087|144185006|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|-0.00676|||||TWO_SIDED||||||Cox Proportional Hazards|||Mitotic rate correlation with progression-free survival for patients on study treatment.||||
72329779|NCT00282087|144185007|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|-0.708|||||TWO_SIDED||||||Cox Proportional Hazards|||Estrogen receptor (ER) status correlation with progression-free survival for patients on study treatment.||||
72329780|NCT00282087|144185008|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|-0.906|||||TWO_SIDED||||||Cox Proportional Hazards|||Progesterone receptor (PR) status correlation with progression-free survival for patients on study treatment.||||
72329781|NCT00282087|144185009|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.207|||||TWO_SIDED||||||Cox Proportional Hazards|||1988 FIGO Stage correlation with progression-free survival for patients on study treatment.||||
72329782|NCT00282087|144185010|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|-0.564|||||TWO_SIDED||||||Cox Proportional Hazards|||Estrogen receptor (ER) or progesterone receptor (PR) positive correlation with progression-free survival for patients on study treatment.||||
72329783|NCT01804049|144185012|SUPERIORITY|Hypothesis: metformin will reduce loss of total lean mass in insulin-resistant older adults over a three year period. It was determined (prior to the initiation of the study) that a sample size of 60 participants per group will have a 73% power to detect a 0.09 m/s difference in gait speed.||||||0.45||||||For lean total body mass, t(118)=0.744, p=0.45.|t-test, 2 sided|T-test calculation for total lean mass: 0.74.||||||0.45
72329784|NCT01804049|144185012|SUPERIORITY|Hypothesis: metformin will reduce loss of total appendicular lean mass in insulin-resistant older adults over a three year period. It was determined (prior to the initiation of the study) that a sample size of 60 participants per group will have a 73% power to detect a 0.09 m/s difference in gait speed.||||||0.79||||||For lean appendicular body mass, t(118) = 0.264, p=0.79.|t-test, 2 sided|T-test calculation appendicular lean mass: 0.26.||||||0.79
72329785|NCT01804049|144185013|SUPERIORITY|||||||0.48|||||||t-test, 2 sided|t(118)=0.703, p=0.48||||||0.48
72329786|NCT03938103|144185030|OTHER|||||||0.101|||||||Mixed Models Analysis|||||||0.101
72329787|NCT03938103|144185031|OTHER|||||||0.383|||||||Mixed Models Analysis|||||||0.383
72329788|NCT01147250|144185044|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority of lixisenatide versus placebo was to be claimed if the upper bound of the 2-sided 95% CI of the hazard ratio was \<1.3.|Hazard Ratio (HR)|1.017|||||TWO_SIDED|95.0|0.886|1.168|||||Lixisenatide vs Placebo|Analysis was performed using Cox proportional hazards model with treatment groups, and region (North America, South and Central America, Western Europe, Eastern Europe, Africa/Near East, and Asia/Pacific) as covariates, and the associated two-sided 95% confidence interval (CI).||1.168|0.886|
72329789|NCT01147250|144185044|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.017||||0.8542|TWO_SIDED|95.0|0.886|1.168|||Log Rank||Lixisenatide vs Placebo|Analysis was performed using Cox proportional hazards model with treatment groups, and region (North America, South and Central America, Western Europe, Eastern Europe, Africa/Near East, and Asia/Pacific) as covariates, and the associated two-sided 95% CI. Superiority of lixisenatide versus placebo was to be claimed if the upper bound of the 2-sided 95% CI of the hazard ratio was \<1.0.||1.168|0.886|0.8542
72329790|NCT03588806|144185048|SUPERIORITY|||||||0.218|||||||ANOVA|Univariate repeated measures ANOVA||||||0.218
72329791|NCT03588806|144185049|SUPERIORITY|||||||0.268|||||||ANOVA|Univariate repeated measures||||||0.268
72329792|NCT03588806|144185050|SUPERIORITY||||||<|0.001|||||||ANOVA|Univariate repeated measures ANOVA||||||<0.001
72329793|NCT03588806|144185051|SUPERIORITY|||||||0.228|||||||ANOVA|Univariate repeated measures ANOVA||||||0.228
72329794|NCT03588806|144185052|SUPERIORITY|||||||0.043|||||||ANOVA|Univariate repeated measures ANOVA||||||0.043
72329795|NCT03588806|144185053|SUPERIORITY|||||||0.486|||||||ANOVA|Univariate repeated measures ANOVA||PROMIS Social Roles score||||0.486
72329796|NCT03588806|144185053|SUPERIORITY|||||||0.078|||||||ANOVA|Univariate repeated measures ANOVA||PROMIS Sleep Disturbance T-Scores||||0.078
72329797|NCT03588806|144185053|SUPERIORITY|||||||0.874|||||||ANOVA|Univariate repeated measures ANOVA||PROMIS Depression T-Scores||||0.874
72329798|NCT03588806|144185053|SUPERIORITY|||||||0.389|||||||ANOVA|Univariate repeated measures ANOVA||PROMIS Anxiety T-Score||||0.389
72329799|NCT03588806|144185054|SUPERIORITY|||||||0.676|||||||ANOVA|Univariate repeated measures ANOVA||||||0.676
72329800|NCT00716482|144185087|SUPERIORITY_OR_OTHER||Specificity of lesion shape|0.694|||<|0.001|TWO_SIDED|95.0||||"P-value was that to test the null hypothesis that there is no change in specificity with addition of the ShearWave elastographic feature.~Significance threshold P-value = 0.05"|McNemar|||Null hypothesis is that there is no difference between the two tests.||||<0.001
72329801|NCT00716482|144185087|SUPERIORITY_OR_OTHER||Lesion homogeneity spec, conservative|0.714|||<|0.001|TWO_SIDED|95.0||||"P-value was that to test the null hypothesis that there is no change in specificity with addition of the ShearWave elastographic feature.~Significance threshold P-value = 0.05"|McNemar|||"Elastography image specificity of the homogeneity of elasticity with the lesion and surrounding tissue using conservative strategy (BIRADS 3 mass upgraded to BIRADS 4a' if they were not homogeneous on the color overlay SW elastographic image; BIRADS 4a mass downgraded to BIRADS 3' if they were very homogeneous).~Null hypothesis is that there is no difference between the two tests."||||<0.001
72329802|NCT00716482|144185087|SUPERIORITY_OR_OTHER||Lesion homogeneity spec, agressive|0.785|||<|0.001|TWO_SIDED|95.0||||"P-value was that to test the null hypothesis that there is no change in specificity with addition of the ShearWave elastographic feature.~Significance threshold P-value = 0.05"|McNemar|||"Elastography image specificity of the homogeneity of elasticity with the lesion and surrounding tissue using aggressive strategy (BIRADS 3 mass upgraded to BIRADS 4a' if they were not homogeneous on the color overlay SW elastographic image; BIRADS 4a mass downgraded to BIRADS 3' if they were very or reasonably homogeneous).~Null hypothesis is that there is no difference between the two tests."||||<0.001
72329803|NCT00716482|144185087|SUPERIORITY_OR_OTHER||Max. elasticity specificity,conservative|0.657||||0.001|TWO_SIDED|95.0||||"P-value was that to test the null hypothesis that there is no change in specificity with addition of the ShearWave elastographic feature.~Significance threshold P-value = 0.05"|McNemar|||"Elastography image specificity of the maximum elasticity using conservative strategy (BIRADS 3 mass upgraded to BIRADS 4a' if maximum elasticity was 160 kiloPascals (kPa) (7.3 m/sec) or more; BIRADS 4a mass downgraded to BIRADS 3' if the maximum elasticity was 30 kPa (3.2 m/sec) or less).~Null hypothesis is that there is no difference between the two tests."||||0.001
72329804|NCT00716482|144185087|SUPERIORITY_OR_OTHER||Max. elasticity specificity, aggressive|0.774|||<|0.001|TWO_SIDED|95.0||||"P-value was that to test the null hypothesis that there is no change in specificity with addition of the ShearWave elastographic feature.~Significance threshold P-value = 0.05"|McNemar|||"Elastography image specificity of the maximum elasticity using aggressive strategy (BIRADS 3 mass upgraded to BIRADS 4a' if maximum elasticity was 160 kPa(7.3 m/sec) or more; BIRADS 4a mass downgraded to BIRADS 3' if the maximum elasticity was 80 kPa (5.2 m/sec) or less).~Null hypothesis is that there is no difference between the two tests."||||<0.001
72329805|NCT00716482|144185087|SUPERIORITY_OR_OTHER||median mean elasticity value specificity|0.626||||0.18|TWO_SIDED|95.0||||"P-value was that to test the null hypothesis that there is no change in specificity with addition of the ShearWave elastographic feature.~Significance threshold P-value = 0.05"|McNemar|||"Elastography image median mean elasticity value.~Null hypothesis is that there is no difference between the two tests."||||0.18
72329806|NCT00716482|144185087|SUPERIORITY_OR_OTHER||Diameter ratio specificity|0.512||||0.006|TWO_SIDED|95.0||||"P-value was that to test the null hypothesis that there is no change in specificity with addition of the ShearWave elastographic feature.~Significance threshold P-value = 0.05"|McNemar|||"Elastography image diameter ratio.~Null hypothesis is that there is no difference between the two tests."||||0.006
72329807|NCT00716482|144185087|SUPERIORITY_OR_OTHER||Median elasticity ratio specificity|0.649||||0.006|TWO_SIDED|95.0||||"P-value was that to test the null hypothesis that there is no change in specificity with addition of the ShearWave elastographic feature.~Significance threshold P-value = 0.05"|McNemar|||"Elastography image median elasticity ratio.~Null hypothesis is that there is no difference between the two tests."||||0.006
72329808|NCT00716482|144185087|SUPERIORITY_OR_OTHER||Max.color scale specificity,conservative|0.703|||<|0.001|TWO_SIDED|95.0||||"P-value was that to test the null hypothesis that there is no change in specificity with addition of the ShearWave elastographic feature.~Significance threshold P-value = 0.05"|McNemar|||"Elastography image specificity of color using a six-point color scale of maximum elasticity in the mass and surrounding parenchyma using conservative strategy (BIRADS 3 mass upgraded to BIRADS 4a' if the max stiffness on the color overlay SW elastographic image was red; BIRADS 4a mass downgraded to BIRADS 3' if the max stiffness on the color overlay SW elastographic image was black to dark blue).~Null hypothesis is that there is no difference between the two tests."||||<0.001
72329809|NCT00716482|144185087|SUPERIORITY_OR_OTHER||Max. color scale specificity, aggressive|0.785|||<|0.001|TWO_SIDED|95.0||||"P-value was that to test the null hypothesis that there is no change in specificity with addition of the ShearWave elastographic feature.~Significance threshold P-value = 0.05~Overall specificity = 78.5%"|McNemar|||"Elastography image specificity of color using a six-point color scale of maximum elasticity in the mass and surrounding parenchyma using aggressive strategy (BIRADS 3 mass upgraded to BIRADS 4a' if the max stiffness on the color overlay SW elastographic image was red; BIRADS 4a mass downgraded to BIRADS 3' if the max stiffness on the color overlay SW elastographic image was black to dark blue, or light blue).~Null hypothesis is that there is no difference between the two tests."||||<0.001
72329810|NCT00716482|144185087|SUPERIORITY_OR_OTHER||Lesion shape sensitivity|0.979||||0.48|TWO_SIDED|95.0||||"P-value was that to test the null hypothesis that there is no change in sensitivity with addition of the ShearWave elastographic feature.~Significance threshold P-value = 0.05"|McNemar|||"Elastography image lesion shape.~Null hypothesis is that there is no difference between the two tests."||||0.48
72329811|NCT00716482|144185087|SUPERIORITY_OR_OTHER||Lesion homogeneity sens, conservative|0.969||||0.74|TWO_SIDED|95.0||||"P-value was that to test the null hypothesis that there is no change in sensitivity with addition of the ShearWave elastographic feature.~Significance threshold P-value = 0.05"|McNemar|||"Elastography image sensitivity of the homogeneity of elasticity with the lesion and surrounding tissue using conservative strategy (BIRADS 3 mass upgraded to BIRADS 4a' if they were not homogeneous on the color overlay SW elastographic image; BIRADS 4a mass downgraded to BIRADS 3' if they were very homogeneous).~Null hypothesis is that there is no difference between the two tests."||||0.74
72329812|NCT00716482|144185087|SUPERIORITY_OR_OTHER||elasticity homogeneity,aggressive,sensit|0.962||||0.37|TWO_SIDED|95.0||||"P-value was that to test the null hypothesis that there is no change in sensitivity with addition of the ShearWave elastographic feature.~Significance threshold P-value = 0.05"|McNemar|||"Elastography image sensitivity of the homogeneity of elasticity with the lesion and surrounding tissue using aggressive strategy (BIRADS 3 mass upgraded to BIRADS 4a' if they were not homogeneous on the color overlay SW elastographic image; BIRADS 4a mass downgraded to BIRADS 3' if they were very or reasonably homogeneous).~Null hypothesis is that there is no difference between the two tests."||||0.37
72329813|NCT00716482|144185087|SUPERIORITY_OR_OTHER||elasticity homegeneity,conservative,sens|0.99||||0.025|TWO_SIDED|95.0||||"P-value was that to test the null hypothesis that there is no change in sensitivity with addition of the ShearWave elastographic feature.~Significance threshold P-value = 0.05~Overall sensitivity = 99.0%"|McNemar|||"Elastography image sensitivity of the maximum elasticity using conservative strategy (BIRADS 3 mass upgraded to BIRADS 4a' if maximum elasticity was 160 kPa(7.3 m/sec) or more; BIRADS 4a mass downgraded to BIRADS 3' if the maximum elasticity was 30 kPa (3.2 m/sec) or less).~Null hypothesis is that there is no difference between the two tests."||||0.025
72329814|NCT00716482|144185087|SUPERIORITY_OR_OTHER||max. elasticity sensitivity,aggressive|0.972|||>|0.99|TWO_SIDED|95.0||||"P-value was that to test the null hypothesis that there is no change in sensitivity with addition of the ShearWave elastographic feature.~Significance threshold P-value = 0.05"|McNemar|||"Elastography image sensitivity of the maximum elasticity using aggressive strategy (BIRADS 3 mass upgraded to BIRADS 4a' if maximum elasticity was 160 kPa(7.3 m/sec) or more; BIRADS 4a mass downgraded to BIRADS 3' if the maximum elasticity was 80 kPa (5.2 m/sec) or less).~Null hypothesis is that there is no difference between the two tests."||||>0.99
72329815|NCT00716482|144185087|SUPERIORITY_OR_OTHER||median mean elasticity value sensitivity|0.986||||0.046|TWO_SIDED|95.0||||"P-value was that to test the null hypothesis that there is no change in sensitivity with addition of the ShearWave elastographic feature.~Significance threshold P-value = 0.05"|McNemar|||"Elastography image median mean elasticity value.~Null hypothesis is that there is no difference between the two tests."||||0.046
72329816|NCT00716482|144185087|SUPERIORITY_OR_OTHER||diameter ratio sensitivity|0.99||||0.025|TWO_SIDED|95.0||||"P-value was that to test the null hypothesis that there is no change in sensitivity with addition of the ShearWave elastographic feature.~Significance threshold P-value = 0.05"|McNemar|||"Elastography image diameter ratio.~Null hypothesis is that there is no difference between the two tests."||||0.025
72329817|NCT00716482|144185087|SUPERIORITY_OR_OTHER||median elasticity ratio sensitivity|0.983||||0.083|TWO_SIDED|95.0||||"P-value was that to test the null hypothesis that there is no change in sensitivity with addition of the ShearWave elastographic feature.~Significance threshold P-value = 0.05"|McNemar|||"Elastography image median elasticity ratio.~Null hypothesis is that there is no difference between the two tests."||||0.083
72329818|NCT00716482|144185087|SUPERIORITY_OR_OTHER||Max.color scale sensitivity,conservative|0.997||||0.008|TWO_SIDED|95.0||||"P-value was that to test the null hypothesis that there is no change in sensitivity with addition of the ShearWave elastographic feature.~Significance threshold P-value = 0.05"|McNemar|||"Elastography image sensitivity of color using a six-point color scale of maximum elasticity in the mass and surrounding parenchyma using conservative strategy (BIRADS 3 mass upgraded to BIRADS 4a' if the max stiffness on the color overlay SW elastographic image was red; BIRADS 4a mass downgraded to BIRADS 3' if the max stiffness on the color overlay SW elastographic image was black to dark blue).~Null hypothesis is that there is no difference between the two tests."||||0.008
72329819|NCT00716482|144185087|SUPERIORITY_OR_OTHER||Max. color scale sensitivity, aggressive|0.986||||0.21|TWO_SIDED|95.0||||"P-value was that to test the null hypothesis that there is no change in sensitivity with addition of the ShearWave elastographic feature.~Significance threshold P-value = 0.05"|McNemar|||"Elastography image sensitivity of color using a six-point color scale of maximum elasticity in the mass and surrounding parenchyma using aggressive strategy (BIRADS 3 mass upgraded to BIRADS 4a' if the max stiffness on the color overlay SW elastographic image was red; BIRADS 4a mass downgraded to BIRADS 3' if the max stiffness on the color overlay SW elastographic image was black to dark blue, or light blue).~Null hypothesis is that there is no difference between the two tests."||||0.21
72329820|NCT00716482|144185088|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Kruskal-Wallis|Kruskal-Wallis one-way ANOVA. Kruskal-Wallis was performed once to get p-values for all of the 9 categories at once.||Null hypothesis: no variance of similarity exists between the three groups||||<0.001
72329821|NCT03248531|144185091|OTHER||Mean posterior difference|31.2|STANDARD_DEVIATION|10.1|||TWO_SIDED|95.0|11.0|50.4|||Regression, Logistic|||Results were based on a Bayesian logistic regression model where the number of responders were assumed to follow a binomial distribution. Treatment and Baseline Hurley Stage were included as predictors in the model. 95% credible intervals were presented for the bimekizumab (BKZ) vs placebo (PBO) comparison.||50.4|11.0|
72329822|NCT03248531|144185091|OTHER||Mean posterior difference|-2.2|STANDARD_DEVIATION|10.6|||TWO_SIDED|60.0|-11.2|6.6|||Regression, Logistic|||Results were based on a Bayesian logistic regression model where the number of responders were assumed to follow a binomial distribution. Treatment and Baseline Hurley Stage were included as predictors in the model. 60% credible intervals were presented for the BKZ vs adalimumab (ADA) comparison.||6.6|-11.2|
72329823|NCT03248531|144185091|OTHER||Pr [Diff>0%] (%)|99.8|||||||||||Regression, Logistic|||Results were based on a Bayesian logistic regression model where the number of responders were assumed to follow a binomial distribution. Treatment and Baseline Hurley Stage were included as predictors in the model.||||
72329824|NCT03248531|144185091|OTHER||Pr[Diff > 0%](%)|42.1|||||||||||Regression, Logistic|||Results were based on a Bayesian logistic regression model where the number of responders were assumed to follow a binomial distribution. Treatment and Baseline Hurley Stage were included as predictors in the model.||||
72329825|NCT04075513|144185133|NON_INFERIORITY|Non-inferiority was based on a relative margin of 10%. Since higher time in range means better outcome, non-inferiority was demonstrated if the lower bound of the two-sided 95% confidence interval (CI) of the difference between Toujeo LS mean and 90% of Tresiba LS mean at Week 12 was \> 0.|Least square mean difference|3.16|STANDARD_ERROR_OF_MEAN|1.163||0.0067|TWO_SIDED|95.0|0.88|5.44||Threshold of significance at \<0.05.|ANCOVA||This estimation parameter corresponds to the difference between Toujeo LS mean and 90% of Tresiba LS mean.|Analysis was performed using ANCOVA model including the fixed categorical effect of treatment groups and randomization stratum of screening HbA1c (\<8.0%, \>=8.0%) and the continuous fixed covariate of Baseline percent time in range value.||5.44|0.88|0.0067
72329826|NCT04075513|144185134|NON_INFERIORITY|Non-inferiority was based on a relative margin of 10%. Since lower CV means better outcome, non-inferiority was demonstrated if the upper bound of the two-sided 95% CI of the difference between Toujeo LS mean and 110% of Tresiba LS mean at Week 12 was \< 0.|Least square mean difference|-5.44|STANDARD_ERROR_OF_MEAN|0.542|<|0.0001|TWO_SIDED|95.0|-6.5|-4.38||Threshold of significance at \<0.05.|ANCOVA||This estimation parameter corresponds to the difference between Toujeo LS mean and 110% of Tresiba LS mean.|A hierarchical step-down testing procedure was used to control type I error. The hierarchical testing was then performed sequentially only when the primary endpoint demonstrated non-inferiority. Analysis was performed using ANCOVA model including the fixed categorical effect of treatment groups and randomization stratum of screening HbA1c (\<8.0%, \>=8.0%) and the continuous fixed covariate of Baseline percent time in range value.||-4.38|-6.50|<0.0001
72329827|NCT04075513|144185135|SUPERIORITY|Superiority was demonstrated if the lower bound of the two-sided 95% CI of the adjusted difference estimate of Toujeo and Tresiba at Week 12 was \>0.|Least square mean difference|-2.35|STANDARD_ERROR_OF_MEAN|1.225||0.0548|TWO_SIDED|95.0|-4.75|0.05||Threshold of significance at \<0.05.|ANCOVA|||A hierarchical step-down testing procedure was used to control type I error. The hierarchical testing was then performed sequentially when the primary endpoint and the secondary endpoint of total CV demonstrated non-inferiority. Analysis was performed using ANCOVA model including the fixed categorical effect of treatment groups and randomization stratum of screening HbA1c (\<8.0%, \>=8.0%) and the continuous fixed covariate of Baseline percent time in range value.||0.05|-4.75|0.0548
72329828|NCT01092780|144185148|SUPERIORITY_OR_OTHER||Difference in LS means|8.16|||||TWO_SIDED|95.0|6.11|10.2||||||Difference in least squares (LS) means||10.20|6.11|
72329829|NCT01092780|144185148|SUPERIORITY_OR_OTHER||Difference in LS means|8.11|||||TWO_SIDED|95.0|6.07|10.15||||||Difference in LS means||10.15|6.07|
72329830|NCT01092780|144185149|SUPERIORITY_OR_OTHER||Difference in LS means|-0.07|||||TWO_SIDED|95.0|-0.1|-0.05||||||Difference in LS means||-0.05|-0.10|
72329831|NCT01092780|144185149|SUPERIORITY_OR_OTHER||Difference in LS means|-0.07|||||TWO_SIDED|95.0|-0.09|-0.05||||||Difference in LS means||-0.05|-0.09|
72329832|NCT01092780|144185151|SUPERIORITY_OR_OTHER||Difference in LS means|-2.05|||||TWO_SIDED|90.0|-3.76|-0.35||||||Difference in LS means||-0.35|-3.76|
72329833|NCT01092780|144185151|SUPERIORITY_OR_OTHER||Difference in LS means|-2.1|||||TWO_SIDED|90.0|-3.79|-0.4||||||Difference in LS means||-0.40|-3.79|
72329834|NCT01092780|144185152|SUPERIORITY_OR_OTHER||Difference in LS means|10.21|||||TWO_SIDED|90.0|8.49|11.92||||||||11.92|8.49|
72329835|NCT01092780|144185153|SUPERIORITY_OR_OTHER||Difference in LS means|-0.07|||||TWO_SIDED|90.0|-0.08|-0.05||||||Difference in LS means||-0.05|-0.08|
72329836|NCT01407952|144185165|SUPERIORITY||Odds Ratio (OR)|2.32||||0.002|TWO_SIDED|95.0|1.36|3.97|||Regression, Logistic|||A intent to treat analysis was performed, using multiple imputation methods.||3.97|1.36|0.002
72329837|NCT01407952|144185165|SUPERIORITY||Odds Ratio (OR)|3.97|||<|0.01|TWO_SIDED|95.0|1.99|7.92||Chi-squared test statistic with one degree of freedom=17.37|Chi-squared|||||7.92|1.99|<0.01
72329838|NCT01407952|144185166|SUPERIORITY||||||<|0.01|||||||t-test, 2 sided|||||||<0.01
72329839|NCT01407952|144185167|SUPERIORITY|||||||0.578|||||||Wilcoxon (Mann-Whitney)|||||||0.578
72329840|NCT01407952|144185168|SUPERIORITY|||||||0.352|||||||Chi-squared|Chi-squared test statistic with one degree of freedom = 0.865||||||0.352
72329841|NCT01407952|144185169|SUPERIORITY|||||||0.769|||||||Cochran-Armitage Trend Test|||||||0.769
72329842|NCT01407952|144185170|SUPERIORITY|||||||0.641|||||||Chi-squared|Chi-square test statistic with one degree of freedom=0.217||||||0.641
72329843|NCT01407952|144185171|SUPERIORITY|||||||0.003|||||||Chi-squared|chi-square test statistic with one degree of freedom=8.82||||||0.003
72329844|NCT01407952|144185172|SUPERIORITY|||||||0.162|||||||Chi-squared|Chi-squared test statistic with one degree of freedom=1.955||||||0.162
72329845|NCT01407952|144185173|SUPERIORITY|||||||0.245|||||||Fisher Exact|||||||0.245
72329846|NCT01407952|144185174|SUPERIORITY||||||<|0.01|||||||Chi-squared|Chi-squared test statistic with one degree of freedom=14.743||||||<0.01
72329847|NCT01407952|144185175|SUPERIORITY||||||<|0.01|||||||Chi-squared|||||||<0.01
72329848|NCT00904670|144185194|SUPERIORITY_OR_OTHER||Least Square (LS) mean difference|-12.46|STANDARD_ERROR_OF_MEAN|1.13|<|0.0001|TWO_SIDED|95.0|-14.75|-10.17|||ANOVA|||Treatment comparisons for observed scores were assessed using linear models with sequence (Placebo/NWP06 and NWP06/Placebo), period, and treatment (NWP06 and Placebo) as fixed effects, and participant within sequence as a repeated effect with a compound symmetry correlation structure. A negative point difference indicated a positive effect of NWP06 over Placebo.||-10.17|-14.75|<0.0001
72329849|NCT00904670|144185195|SUPERIORITY_OR_OTHER||LS mean difference|-6.32|STANDARD_ERROR_OF_MEAN|1.09|<|0.0001|TWO_SIDED|95.0|-8.53|-4.11|||ANOVA|||Hour 0.75: Treatment comparisons for observed scores were assessed using linear models with sequence (Placebo/NWP06 and NWP06/Placebo), period, and treatment (NWP06 and Placebo) as fixed effects, and participant within sequence as a repeated effect with a compound symmetry correlation structure. A negative point difference indicated a positive effect of NWP06 over Placebo.||-4.11|-8.53|<0.0001
72329850|NCT00904670|144185195|SUPERIORITY_OR_OTHER||LS mean difference|-9.98|STANDARD_ERROR_OF_MEAN|1.02|<|0.0001|TWO_SIDED|95.0|-12.04|-7.91|||ANOVA|||Hour 2: Treatment comparisons for observed scores were assessed using linear models with sequence (Placebo/NWP06 and NWP06/Placebo), period, and treatment (NWP06 and Placebo) as fixed effects, and participant within sequence as a repeated effect with a compound symmetry correlation structure. A negative point difference indicated a positive effect of NWP06 over Placebo.||-7.91|-12.04|<0.0001
72329851|NCT00904670|144185195|SUPERIORITY_OR_OTHER||LS mean difference|-9.33|STANDARD_ERROR_OF_MEAN|1.28|<|0.0001|TWO_SIDED|95.0|-11.92|-6.75|||ANOVA|||Hour 8: Treatment comparisons for observed scores were assessed using linear models with sequence (Placebo/NWP06 and NWP06/Placebo), period, and treatment (NWP06 and Placebo) as fixed effects, and participant within sequence as a repeated effect with a compound symmetry correlation structure. A negative point difference indicated a positive effect of NWP06 over Placebo.||-6.75|-11.92|<0.0001
72329852|NCT00904670|144185195|SUPERIORITY_OR_OTHER||LS mean difference|-3.79|STANDARD_ERROR_OF_MEAN|1.11||0.0016|TWO_SIDED|95.0|-6.04|-1.54|||ANOVA|||Hour 10: Treatment comparisons for observed scores were assessed using linear models with sequence (Placebo/NWP06 and NWP06/Placebo), period, and treatment (NWP06 and Placebo) as fixed effects, and participant within sequence as a repeated effect with a compound symmetry correlation structure. A negative point difference indicated a positive effect of NWP06 over Placebo.||-1.54|-6.04|0.0016
72329853|NCT00904670|144185195|SUPERIORITY_OR_OTHER||LS mean difference|-4.77|STANDARD_ERROR_OF_MEAN|1.4||0.0016|TWO_SIDED|95.0|-7.61|-1.94|||ANOVA|||Hour 12: Treatment comparisons for observed scores were assessed using linear models with sequence (Placebo/NWP06 and NWP06/Placebo), period, and treatment (NWP06 and Placebo) as fixed effects, and participant within sequence as a repeated effect with a compound symmetry correlation structure. A negative point difference indicated a positive effect of NWP06 over Placebo.||-1.94|-7.61|0.0016
72329854|NCT00904670|144185196|SUPERIORITY_OR_OTHER||LS mean difference|-1.12|STANDARD_ERROR_OF_MEAN|0.38||0.0051|TWO_SIDED|95.0|-1.88|-0.36|||ANOVA|||Hour 0.75: Treatment comparisons for observed scores were assessed using linear models with sequence (Placebo/NWP06 and NWP06/Placebo), period, and treatment (NWP06 and Placebo) as fixed effects, and participant within sequence as a repeated effect with a compound symmetry correlation structure. A negative point difference indicated a positive effect of NWP06 over Placebo.||-0.36|-1.88|0.0051
72329855|NCT00904670|144185196|SUPERIORITY_OR_OTHER||LS mean difference|-1.59|STANDARD_ERROR_OF_MEAN|0.31|<|0.0001|TWO_SIDED|95.0|-2.23|-0.95|||ANOVA|||Hour 2: Treatment comparisons for observed scores were assessed using linear models with sequence (Placebo/NWP06 and NWP06/Placebo), period, and treatment (NWP06 and Placebo) as fixed effects, and participant within sequence as a repeated effect with a compound symmetry correlation structure. A negative point difference indicated a positive effect of NWP06 over Placebo.||-0.95|-2.23|<0.0001
72329856|NCT00904670|144185196|SUPERIORITY_OR_OTHER||LS mean difference|-2.28|STANDARD_ERROR_OF_MEAN|0.54||0.0001|TWO_SIDED|95.0|-3.37|-1.2|||ANOVA|||Hour 4: Treatment comparisons for observed scores were assessed using linear models with sequence (Placebo/NWP06 and NWP06/Placebo), period, and treatment (NWP06 and Placebo) as fixed effects, and participant within sequence as a repeated effect with a compound symmetry correlation structure. A negative point difference indicated a positive effect of NWP06 over Placebo.||-1.20|-3.37|0.0001
72329857|NCT00904670|144185196|SUPERIORITY_OR_OTHER||LS mean difference|-1.49|STANDARD_ERROR_OF_MEAN|0.51||0.0055|TWO_SIDED|95.0|-2.52|-0.47|||ANOVA|||Hour 8: Treatment comparisons for observed scores were assessed using linear models with sequence (Placebo/NWP06 and NWP06/Placebo), period, and treatment (NWP06 and Placebo) as fixed effects, and participant within sequence as a repeated effect with a compound symmetry correlation structure. A negative point difference indicated a positive effect of NWP06 over Placebo.||-0.47|-2.52|0.0055
72329858|NCT00904670|144185196|SUPERIORITY_OR_OTHER||LS mean difference|-0.54|STANDARD_ERROR_OF_MEAN|0.41||0.1977|TWO_SIDED|95.0|-1.38|0.29|||ANOVA|||Hour 10: Treatment comparisons for observed scores were assessed using linear models with sequence (Placebo/NWP06 and NWP06/Placebo), period, and treatment (NWP06 and Placebo) as fixed effects, and participant within sequence as a repeated effect with a compound symmetry correlation structure. A negative point difference indicated a positive effect of NWP06 over Placebo.||0.29|-1.38|0.1977
72329859|NCT00904670|144185196|SUPERIORITY_OR_OTHER||LS mean difference|-0.88|STANDARD_ERROR_OF_MEAN|0.43||0.0491|TWO_SIDED|95.0|-1.76|0.0|||ANOVA|||Hour 12: Treatment comparisons for observed scores were assessed using linear models with sequence (Placebo/NWP06 and NWP06/Placebo), period, and treatment (NWP06 and Placebo) as fixed effects, and participant within sequence as a repeated effect with a compound symmetry correlation structure. A negative point difference indicated a positive effect of NWP06 over Placebo.||0.00|-1.76|0.0491
72329860|NCT00904670|144185197|SUPERIORITY_OR_OTHER||LS mean difference|-1.69|STANDARD_ERROR_OF_MEAN|0.33|<|0.0001|TWO_SIDED|95.0|-2.36|-1.02|||ANOVA|||Hour 0.75: Treatment comparisons for observed scores were assessed using linear models with sequence (Placebo/NWP06 and NWP06/Placebo), period, and treatment (NWP06 and Placebo) as fixed effects, and participant within sequence as a repeated effect with a compound symmetry correlation structure. A negative point difference indicated a positive effect of NWP06 over Placebo.||-1.02|-2.36|<0.0001
72329861|NCT00904670|144185197|SUPERIORITY_OR_OTHER||LS mean difference|-2.66|STANDARD_ERROR_OF_MEAN|0.41|<|0.0001|TWO_SIDED|95.0|-3.5|-1.82|||ANOVA|||Hour 2: Treatment comparisons for observed scores were assessed using linear models with sequence (Placebo/NWP06 and NWP06/Placebo), period, and treatment (NWP06 and Placebo) as fixed effects, and participant within sequence as a repeated effect with a compound symmetry correlation structure. A negative point difference indicated a positive effect of NWP06 over Placebo.||-1.82|-3.50|<0.0001
72329862|NCT00904670|144185197|SUPERIORITY_OR_OTHER||LS mean difference|-2.95|STANDARD_ERROR_OF_MEAN|0.4|<|0.0001|TWO_SIDED|95.0|-3.77|-2.13|||ANOVA|||Hour 4: Treatment comparisons for observed scores were assessed using linear models with sequence (Placebo/NWP06 and NWP06/Placebo), period, and treatment (NWP06 and Placebo) as fixed effects, and participant within sequence as a repeated effect with a compound symmetry correlation structure. A negative point difference indicated a positive effect of NWP06 over Placebo.||-2.13|-3.77|<0.0001
72329863|NCT00904670|144185197|SUPERIORITY_OR_OTHER||LS mean difference|-2.49|STANDARD_ERROR_OF_MEAN|0.41|<|0.0001|TWO_SIDED|95.0|-3.33|-1.66|||ANOVA|||Hour 8: Treatment comparisons for observed scores were assessed using linear models with sequence (Placebo/NWP06 and NWP06/Placebo), period, and treatment (NWP06 and Placebo) as fixed effects, and participant within sequence as a repeated effect with a compound symmetry correlation structure. A negative point difference indicated a positive effect of NWP06 over Placebo.||-1.66|-3.33|<0.0001
72329864|NCT00904670|144185197|SUPERIORITY_OR_OTHER||LS mean difference|-1.26|STANDARD_ERROR_OF_MEAN|0.4||0.0035|TWO_SIDED|95.0|-2.07|-0.44|||ANOVA|||Hour 10: Treatment comparisons for observed scores were assessed using linear models with sequence (Placebo/NWP06 and NWP06/Placebo), period, and treatment (NWP06 and Placebo) as fixed effects, and participant within sequence as a repeated effect with a compound symmetry correlation structure. A negative point difference indicated a positive effect of NWP06 over Placebo.||-0.44|-2.07|0.0035
72329865|NCT00904670|144185197|SUPERIORITY_OR_OTHER||LS mean difference|-1.43|STANDARD_ERROR_OF_MEAN|0.53||0.0109|TWO_SIDED|95.0|-2.51|-0.35|||ANOVA|||Hour 12: Treatment comparisons for observed scores were assessed using linear models with sequence (Placebo/NWP06 and NWP06/Placebo), period, and treatment (NWP06 and Placebo) as fixed effects, and participant within sequence as a repeated effect with a compound symmetry correlation structure. A negative point difference indicated a positive effect of NWP06 over Placebo.||-0.35|-2.51|0.0109
72329866|NCT00904670|144185198|SUPERIORITY_OR_OTHER||LS mean difference|25.61|STANDARD_ERROR_OF_MEAN|4.61|<|0.0001|TWO_SIDED|95.0|16.26|34.96|||ANOVA|||Hour 0.75: Treatment comparisons for observed scores were assessed using linear models with sequence (Placebo/NWP06 and NWP06/Placebo), period, and treatment (NWP06 and Placebo) as fixed effects, and participant within sequence as a repeated effect with a compound symmetry correlation structure. A negative point difference indicated a positive effect of NWP06 over Placebo.||34.96|16.26|<0.0001
72329867|NCT00904670|144185198|SUPERIORITY_OR_OTHER||LS mean difference|37.1|STANDARD_ERROR_OF_MEAN|5.21|<|0.0001|TWO_SIDED|95.0|26.54|47.66|||ANOVA|||Hour 2: Treatment comparisons for observed scores were assessed using linear models with sequence (Placebo/NWP06 and NWP06/Placebo), period, and treatment (NWP06 and Placebo) as fixed effects, and participant within sequence as a repeated effect with a compound symmetry correlation structure. A negative point difference indicated a positive effect of NWP06 over Placebo.||47.66|26.54|<0.0001
72329868|NCT00904670|144185198|SUPERIORITY_OR_OTHER||LS mean difference|45.77|STANDARD_ERROR_OF_MEAN|7.35|<|0.0001|TWO_SIDED|95.0|30.89|60.65|||ANOVA|||Hour 4: Treatment comparisons for observed scores were assessed using linear models with sequence (Placebo/NWP06 and NWP06/Placebo), period, and treatment (NWP06 and Placebo) as fixed effects, and participant within sequence as a repeated effect with a compound symmetry correlation structure. A negative point difference indicated a positive effect of NWP06 over Placebo.||60.65|30.89|<0.0001
72329869|NCT00904670|144185198|SUPERIORITY_OR_OTHER||LS mean difference|35.46|STANDARD_ERROR_OF_MEAN|6.57|<|0.0001|TWO_SIDED|95.0|22.14|48.78|||ANOVA|||Hour 8: Treatment comparisons for observed scores were assessed using linear models with sequence (Placebo/NWP06 and NWP06/Placebo), period, and treatment (NWP06 and Placebo) as fixed effects, and participant within sequence as a repeated effect with a compound symmetry correlation structure. A negative point difference indicated a positive effect of NWP06 over Placebo.||48.78|22.14|<0.0001
72329870|NCT00904670|144185198|SUPERIORITY_OR_OTHER||LS mean difference|14.86|STANDARD_ERROR_OF_MEAN|5.86||0.0155|TWO_SIDED|95.0|3.0|26.73|||ANOVA|||Hour 10: Treatment comparisons for observed scores were assessed using linear models with sequence (Placebo/NWP06 and NWP06/Placebo), period, and treatment (NWP06 and Placebo) as fixed effects, and participant within sequence as a repeated effect with a compound symmetry correlation structure. A negative point difference indicated a positive effect of NWP06 over Placebo.||26.73|3.00|0.0155
72329871|NCT00904670|144185198|SUPERIORITY_OR_OTHER||LS mean difference|20.69|STANDARD_ERROR_OF_MEAN|6.18||0.0019|TWO_SIDED|95.0|8.17|33.22|||ANOVA|||Hour 12: Treatment comparisons for observed scores were assessed using linear models with sequence (Placebo/NWP06 and NWP06/Placebo), period, and treatment (NWP06 and Placebo) as fixed effects, and participant within sequence as a repeated effect with a compound symmetry correlation structure. A negative point difference indicated a positive effect of NWP06 over Placebo.||33.22|8.17|0.0019
72329872|NCT00904670|144185200|SUPERIORITY_OR_OTHER||LS mean difference|-1.8|STANDARD_ERROR_OF_MEAN|0.52||0.0014|TWO_SIDED|95.0|-2.85|-0.74|||ANOVA|||Hour 0.75: Treatment comparisons for observed scores were assessed using linear models with sequence (Placebo/NWP06 and NWP06/Placebo), period, and treatment (NWP06 and Placebo) as fixed effects, and participant within sequence as a repeated effect with a compound symmetry correlation structure. A negative point difference indicated a positive effect of NWP06 over Placebo.||-0.74|-2.85|0.0014
72329873|NCT00904670|144185200|SUPERIORITY_OR_OTHER||LS mean difference|-2.79|STANDARD_ERROR_OF_MEAN|0.48|<|0.0001|TWO_SIDED|95.0|-3.76|-1.82|||ANOVA|||Hour 2: Treatment comparisons for observed scores were assessed using linear models with sequence (Placebo/NWP06 and NWP06/Placebo), period, and treatment (NWP06 and Placebo) as fixed effects, and participant within sequence as a repeated effect with a compound symmetry correlation structure. A negative point difference indicated a positive effect of NWP06 over Placebo.||-1.82|-3.76|<0.0001
72329874|NCT00904670|144185200|SUPERIORITY_OR_OTHER||LS mean difference|-3.89|STANDARD_ERROR_OF_MEAN|0.6|<|0.0001|TWO_SIDED|95.0|-5.12|-2.67|||ANOVA|||Hour 4: Treatment comparisons for observed scores were assessed using linear models with sequence (Placebo/NWP06 and NWP06/Placebo), period, and treatment (NWP06 and Placebo) as fixed effects, and participant within sequence as a repeated effect with a compound symmetry correlation structure. A negative point difference indicated a positive effect of NWP06 over Placebo.||-2.67|-5.12|<0.0001
72329875|NCT00904670|144185200|SUPERIORITY_OR_OTHER||LS mean difference|-2.65|STANDARD_ERROR_OF_MEAN|0.65||0.0002|TWO_SIDED|95.0|-3.97|-1.33|||ANOVA|||Hour 8: Treatment comparisons for observed scores were assessed using linear models with sequence (Placebo/NWP06 and NWP06/Placebo), period, and treatment (NWP06 and Placebo) as fixed effects, and participant within sequence as a repeated effect with a compound symmetry correlation structure. A negative point difference indicated a positive effect of NWP06 over Placebo.||-1.33|-3.97|0.0002
72329876|NCT00904670|144185200|SUPERIORITY_OR_OTHER||LS mean difference|-0.43|STANDARD_ERROR_OF_MEAN|0.45||0.3492|TWO_SIDED|95.0|-1.34|0.49|||ANOVA|||Hour 10: Treatment comparisons for observed scores were assessed using linear models with sequence (Placebo/NWP06 and NWP06/Placebo), period, and treatment (NWP06 and Placebo) as fixed effects, and participant within sequence as a repeated effect with a compound symmetry correlation structure. A negative point difference indicated a positive effect of NWP06 over Placebo.||0.49|-1.34|0.3492
72329877|NCT00904670|144185200|SUPERIORITY_OR_OTHER||LS mean difference|-1.34|STANDARD_ERROR_OF_MEAN|0.5||0.0105|TWO_SIDED|95.0|-2.34|-0.33|||ANOVA|||Hour 12: Treatment comparisons for observed scores were assessed using linear models with sequence (Placebo/NWP06 and NWP06/Placebo), period, and treatment (NWP06 and Placebo) as fixed effects, and participant within sequence as a repeated effect with a compound symmetry correlation structure. A negative point difference indicated a positive effect of NWP06 over Placebo.||-0.33|-2.34|0.0105
72329878|NCT00904670|144185201|SUPERIORITY_OR_OTHER||LS mean difference|-1.72|STANDARD_ERROR_OF_MEAN|0.35|<|0.0001|TWO_SIDED|95.0|-2.43|-1.0|||ANOVA|||Hour 0.75: Treatment comparisons for observed scores were assessed using linear models with sequence (Placebo/NWP06 and NWP06/Placebo), period, and treatment (NWP06 and Placebo) as fixed effects, and participant within sequence as a repeated effect with a compound symmetry correlation structure. A negative point difference indicated a positive effect of NWP06 over Placebo.||-1.00|-2.43|<0.0001
72329879|NCT00904670|144185201|SUPERIORITY_OR_OTHER||LS mean difference|-2.94|STANDARD_ERROR_OF_MEAN|0.41|<|0.0001|TWO_SIDED|95.0|-3.78|-2.1|||ANOVA|||Hour 2: Treatment comparisons for observed scores were assessed using linear models with sequence (Placebo/NWP06 and NWP06/Placebo), period, and treatment (NWP06 and Placebo) as fixed effects, and participant within sequence as a repeated effect with a compound symmetry correlation structure. A negative point difference indicated a positive effect of NWP06 over Placebo.||-2.10|-3.78|<0.0001
72329880|NCT00904670|144185201|SUPERIORITY_OR_OTHER||LS mean difference|-3.34|STANDARD_ERROR_OF_MEAN|0.38|<|0.0001|TWO_SIDED|95.0|-4.11|-2.57|||ANOVA|||Hour 4: Treatment comparisons for observed scores were assessed using linear models with sequence (Placebo/NWP06 and NWP06/Placebo), period, and treatment (NWP06 and Placebo) as fixed effects, and participant within sequence as a repeated effect with a compound symmetry correlation structure. A negative point difference indicated a positive effect of NWP06 over Placebo.||-2.57|-4.11|<0.0001
72329881|NCT00904670|144185201|SUPERIORITY_OR_OTHER||LS mean difference|-2.7|STANDARD_ERROR_OF_MEAN|0.46|<|0.0001|TWO_SIDED|95.0|-3.64|-1.76|||ANOVA|||Hour 8: Treatment comparisons for observed scores were assessed using linear models with sequence (Placebo/NWP06 and NWP06/Placebo), period, and treatment (NWP06 and Placebo) as fixed effects, and participant within sequence as a repeated effect with a compound symmetry correlation structure. A negative point difference indicated a positive effect of NWP06 over Placebo.||-1.76|-3.64|<0.0001
72329882|NCT00904670|144185201|SUPERIORITY_OR_OTHER||LS mean difference|-1.57|STANDARD_ERROR_OF_MEAN|0.41||0.0006|TWO_SIDED|95.0|-2.4|-0.73|||ANOVA|||Hour 10: Treatment comparisons for observed scores were assessed using linear models with sequence (Placebo/NWP06 and NWP06/Placebo), period, and treatment (NWP06 and Placebo) as fixed effects, and participant within sequence as a repeated effect with a compound symmetry correlation structure. A negative point difference indicated a positive effect of NWP06 over Placebo.||-0.73|-2.40|0.0006
72329883|NCT00904670|144185201|SUPERIORITY_OR_OTHER||LS mean difference|-1.12|STANDARD_ERROR_OF_MEAN|0.4||0.0087|TWO_SIDED|95.0|-1.94|-0.3|||ANOVA|||Hour 12: Treatment comparisons for observed scores were assessed using linear models with sequence (Placebo/NWP06 and NWP06/Placebo), period, and treatment (NWP06 and Placebo) as fixed effects, and participant within sequence as a repeated effect with a compound symmetry correlation structure. A negative point difference indicated a positive effect of NWP06 over Placebo.||-0.30|-1.94|0.0087
72329884|NCT00286091|144185202|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.85||||0.0284|TWO_SIDED|95.0|0.73|0.98|||Wald test||Based on the Cox proportional hazards model stratified by PSA ≥ 8.0 ng/mL, PSA doubling time ≤ 10 months and previous or current chemotherapy for prostate cancer. A hazard ratio \< 1 favors denosumab.|Primary and secondary endpoint analyses were conducted hierarchically. To preserve an overall type I error rate of 0.05, a 0.0488 2-sided test of bone metastasis-free survival was performed. If superiority of denosumab over placebo was established, time to first bone metastasis was tested with a 2-sided significance level of 0.050. If superiority of denosumab over placebo was also established, overall survival time was tested at a 2-sided significance level of 0.050.||0.98|0.73|0.0284
72329885|NCT00286091|144185203|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.84||||0.0317|TWO_SIDED|95.0|0.71|0.98|||Wald test||Based on the Cox proportional hazards model stratified by PSA ≥ 8.0 ng/mL, PSA doubling time ≤ 10 months and previous or current chemotherapy for prostate cancer. A hazard ratio \< 1 favors denosumab.|||0.98|0.71|0.0317
72329886|NCT00286091|144185204|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.01||||0.9125|TWO_SIDED|95.0|0.85|1.2|||Wald test||Based on the Cox proportional hazards model stratified by PSA ≥ 8.0 ng/mL, PSA doubling time ≤ 10 months and previous or current chemotherapy for prostate cancer. A hazard ratio \< 1 favors denosumab.|||1.20|0.85|0.9125
72329887|NCT03423238|144185208|SUPERIORITY|||||||0.388|||||||t-test, 2 sided|||Baseline||||0.388
72329888|NCT03423238|144185209|SUPERIORITY|||||||0.017|||||||ANCOVA|||Month 3||||0.017
72329889|NCT03423238|144185209|SUPERIORITY|||||||0.002|||||||ANCOVA|||Month 6||||0.002
72329890|NCT03423238|144185210|SUPERIORITY|||||||0.653|||||||t-test, 2 sided|||Baseline||||0.653
72329891|NCT03423238|144185211|SUPERIORITY|||||||0.684|||||||ANCOVA|||Month 3||||0.684
72329892|NCT03423238|144185211|SUPERIORITY|||||||0.458|||||||ANCOVA|||Month 6||||0.458
72329893|NCT03423238|144185212|SUPERIORITY|||||||0.55|||||||t-test, 2 sided|||Baseline||||0.550
72329894|NCT03423238|144185213|SUPERIORITY|||||||0.973|||||||ANCOVA|||Month 3||||0.973
72329895|NCT03423238|144185213|SUPERIORITY|||||||0.432|||||||ANCOVA|||Month 6||||0.432
72329896|NCT03423238|144185214|SUPERIORITY|||||||0.23063|||||||t-test, 2 sided|||Baseline||||0.23063
72329897|NCT03423238|144185215|SUPERIORITY|||||||0.854|||||||ANCOVA|||Month 3||||0.854
72329898|NCT03423238|144185215|SUPERIORITY|||||||0.874|||||||ANCOVA|||Month 6||||0.874
72329899|NCT03423238|144185216|SUPERIORITY|||||||0.563|||||||t-test, 2 sided|||Baseline||||0.563
72329900|NCT03423238|144185217|SUPERIORITY|||||||0.008|||||||ANCOVA|||Month 3||||0.008
72329901|NCT03423238|144185217|SUPERIORITY|||||||0.922|||||||ANCOVA|||Month 6||||0.922
72329902|NCT03423238|144185218|SUPERIORITY|||||||0.667|||||||t-test, 2 sided|||Baseline||||0.667
72329903|NCT03423238|144185219|SUPERIORITY|||||||0.692|||||||ANCOVA|||Month 3||||0.692
72329904|NCT03423238|144185219|SUPERIORITY|||||||0.59|||||||ANCOVA|||Month 6||||0.590
72329905|NCT03423238|144185220|SUPERIORITY|||||||0.844|||||||t-test, 2 sided|||Baseline||||0.844
72329906|NCT03423238|144185221|SUPERIORITY|||||||0.721|||||||ANCOVA|||Month 3||||0.721
72329907|NCT03423238|144185221|SUPERIORITY|||||||0.851|||||||ANCOVA|||Month 6||||0.851
72329908|NCT03423238|144185222|SUPERIORITY|||||||0.815|||||||t-test, 2 sided|||Baseline||||0.815
72329909|NCT03423238|144185223|SUPERIORITY|||||||0.488|||||||ANCOVA|||Month 3||||0.488
72329910|NCT03423238|144185223|SUPERIORITY|||||||0.237|||||||ANCOVA|||Month 6||||0.237
72329911|NCT03423238|144185224|SUPERIORITY|||||||0.506|||||||t-test, 2 sided|||||||0.506
72329912|NCT03423238|144185225|SUPERIORITY|||||||0.549|||||||ANCOVA|||Month 3||||0.549
72329913|NCT03423238|144185225|SUPERIORITY|||||||0.303|||||||ANCOVA|||Month 6||||0.303
72329914|NCT03423238|144185226|SUPERIORITY|||||||0.934|||||||t-test, 2 sided|||Baseline||||0.934
72329915|NCT03423238|144185227|SUPERIORITY|||||||0.792|||||||ANCOVA|||Month 3||||0.792
72329916|NCT03423238|144185227|SUPERIORITY|||||||0.417|||||||ANCOVA|||Month 6||||0.417
72329917|NCT03423238|144185228|SUPERIORITY|||||||0.685|||||||t-test, 2 sided|||Baseline||||0.685
72329918|NCT03423238|144185229|SUPERIORITY|||||||0.854|||||||ANCOVA|||Month 3||||0.854
72329919|NCT03423238|144185229|SUPERIORITY|||||||0.903|||||||ANCOVA|||Month 6||||0.903
72329920|NCT03423238|144185230|SUPERIORITY|||||||0.569|||||||t-test, 2 sided|||Baseline||||0.569
72329921|NCT03423238|144185231|SUPERIORITY|||||||0.824|||||||ANCOVA|||Month 3||||0.824
72329922|NCT03423238|144185231|SUPERIORITY|||||||0.401|||||||ANCOVA|||Month 6||||0.401
72329923|NCT03423238|144185232|SUPERIORITY|||||||0.188|||||||t-test, 2 sided|||Baseline||||0.188
72329924|NCT03423238|144185233|SUPERIORITY|||||||0.338|||||||ANCOVA|||Month 3||||0.338
72329925|NCT03423238|144185233|SUPERIORITY|||||||0.484|||||||ANCOVA|||Month 6||||0.484
72329926|NCT03423238|144185234|SUPERIORITY|||||||0.533|||||||t-test, 2 sided|||Baseline||||0.533
72329927|NCT03423238|144185235|SUPERIORITY|||||||0.992|||||||ANCOVA|||Month 3||||0.992
72329928|NCT03423238|144185235|SUPERIORITY|||||||0.639|||||||ANCOVA|||Month 6||||0.639
72329929|NCT01479764|144185255|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.0|||<|0.0001|TWO_SIDED|95.0|0.0|0.059|||Pearson's Chi-square test|||Sugammadex is the numerator and Neostigmine/Glycopyrrolate is the denominator.||0.059|0.000|<0.0001
72329930|NCT01479764|144185256|SUPERIORITY_OR_OTHER||Estimated Ratio of Geometric Means|0.83||||0.021|TWO_SIDED|95.0|0.71|0.97|||ANCOVA|Adjusted for age, American Society of Anesthesiologists class, Body Mass Index, comorbidity index \& length of surgical procedure||Sugammadex is the numerator and neostigmine/glycopyrrolate is the denominator. Used log-transformed time intervals.||0.97|0.71|0.021
72329931|NCT00260832|144185259|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1079|TWO_SIDED|95.0|||||Kaplan-Meier|||The primary treatment comparison was based on two sided long-rank test stratified by age, cytogenetic risk, ECOG performance status||||0.1079
72329932|NCT00260832|144185260|SUPERIORITY||Odds Ratio (OR)|2.5||||0.0011|TWO_SIDED|95.0|1.4|4.78|||Fisher Exact|||||4.78|1.40|0.0011
72329933|NCT03745638|144185261|SUPERIORITY||Odds Ratio (OR)|6.38|||<|0.0001|TWO_SIDED|95.0|3.556|11.923||The unadjusted p-values between each treatment group and vehicle were calculated based on Exact Logistic Regression including treatment and stratification factors to test the treatment difference.|Exact Logistic Regression|||||11.923|3.556|< 0.0001
72329934|NCT03745638|144185261|SUPERIORITY||Odds Ratio (OR)|7.5|||<|0.0001|TWO_SIDED|95.0|4.178|14.04||The unadjusted p-values between each treatment group and vehicle were calculated based on Exact Logistic Regression including treatment and stratification factors to test the treatment difference.|Exact Logistic Regression|||||14.040|4.178|< 0.0001
72329935|NCT03745638|144185262|SUPERIORITY||Odds Ratio (OR)|4.04|||<|0.0001|TWO_SIDED|95.0|2.441|6.808||The unadjusted p-values between each treatment group and vehicle were calculated based on Exact Logistic Regression including treatment and stratification factors to test the treatment difference.|Exact Logistic Regression|||||6.808|2.441|< 0.0001
72329936|NCT03745638|144185262|SUPERIORITY||Odds Ratio (OR)|5.22|||<|0.0001|TWO_SIDED|95.0|3.145|8.831||The unadjusted p-values between each treatment group and vehicle were calculated based on Exact Logistic Regression including treatment and stratification factors to test the treatment difference.|Exact Logistic Regression|||||8.831|3.145|< 0.0001
72329937|NCT03745638|144185263|SUPERIORITY||Odds Ratio (OR)|3.66||||0.0002|TWO_SIDED|95.0|1.773|8.083||The unadjusted p-values between each treatment group and vehicle were calculated based on Exact Logistic Regression including treatment and stratification factors to test the treatment difference.|Exact Logistic Regression|||||8.083|1.773|0.0002
72329938|NCT03745638|144185263|SUPERIORITY||Odds Ratio (OR)|6.01|||<|0.0001|TWO_SIDED|95.0|2.931|13.22||The unadjusted p-values between each treatment group and vehicle were calculated based on Exact Logistic Regression including treatment and stratification factors to test the treatment difference.|Exact Logistic Regression|||||13.220|2.931|< 0.0001
72329939|NCT03745638|144185264|SUPERIORITY||Odds Ratio (OR)|2.56||||0.0081|TWO_SIDED|95.0|1.242|5.723||The unadjusted p-values between each treatment group and vehicle were calculated based on Exact Logistic Regression including treatment and stratification factors to test the treatment difference.|Exact Logistic Regression|||||5.723|1.242|0.0081
72329940|NCT03745638|144185264|SUPERIORITY||Odds Ratio (OR)|2.74||||0.0039|TWO_SIDED|95.0|1.334|6.083||The unadjusted p-values between each treatment group and vehicle were calculated based on Exact Logistic Regression including treatment and stratification factors to test the treatment difference.|Exact Logistic Regression|||||6.083|1.334|0.0039
72329941|NCT03745638|144185265|SUPERIORITY||Odds Ratio (OR)|1.67||||0.1421|TWO_SIDED|95.0|0.862|3.391||The unadjusted p-values between each treatment group and vehicle were calculated based on Exact Logistic Regression including treatment and stratification factors to test the treatment difference.|Exact Logistic Regression|||||3.391|0.862|0.1421
72329942|NCT03745638|144185265|SUPERIORITY||Odds Ratio (OR)|1.82||||0.0746|TWO_SIDED|95.0|0.949|3.665||The unadjusted p-values between each treatment group and vehicle were calculated based on Exact Logistic Regression including treatment and stratification factors to test the treatment difference.|Exact Logistic Regression|||||3.665|0.949|0.0746
72329943|NCT03745638|144185275|SUPERIORITY||Least Squares Mean Difference|-35.48|STANDARD_ERROR_OF_MEAN|4.16|<|0.0001|TWO_SIDED|95.0|-43.64|-27.32|||Mixed-Model with Repeated Measures|The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.||Percent change from Baseline in EASI score at Week 2||-27.32|-43.64|< 0.0001
72329944|NCT03745638|144185275|SUPERIORITY||Least Squares Method of Mean Difference]|-40.29|STANDARD_ERROR_OF_MEAN|4.15|<|0.0001|TWO_SIDED|95.0|-48.44|-32.13|||Mixed-Model with Repeated Measures|The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.||Percent change from Baseline in EASI score at Week 2||-32.13|-48.44|< 0.0001
72329945|NCT03745638|144185275|SUPERIORITY||Least Squares Mean Difference|-45.01|STANDARD_ERROR_OF_MEAN|4.72|<|0.0001|TWO_SIDED|95.0|-54.28|-35.74|||Mixed-Model with Repeated Measures|The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.||Percent change from Baseline in EASI score at Week 4||-35.74|-54.28|< 0.0001
72329946|NCT03745638|144185275|SUPERIORITY||Least Squares Mean Difference|-48.05|STANDARD_ERROR_OF_MEAN|4.71|<|0.0001|TWO_SIDED|95.0|-57.3|-38.79|||Mixed-Model with Repeated Measures|The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.||Percent change from Baseline in EASI score at Week 4||-38.79|-57.30|< 0.0001
72329947|NCT03745638|144185275|SUPERIORITY||Least Squares Mean Difference|-33.13|STANDARD_ERROR_OF_MEAN|4.49|<|0.0001|TWO_SIDED|95.0|-41.95|-24.3||The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.|Mixed-Model with Repeated Measures|||Percent change from Baseline in EASI score at Week 8||-24.30|-41.95|< 0.0001
72329948|NCT03745638|144185275|SUPERIORITY||Least Squares Mean Difference|-39.52|STANDARD_ERROR_OF_MEAN|4.48|<|0.0001|TWO_SIDED|95.0|-48.32|-30.72|||Mixed-Model with Repeated Measures|The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.||Percent change from Baseline in EASI score at Week 8||-30.72|-48.32|< 0.0001
72329949|NCT03745638|144185276|SUPERIORITY||Least Squares Mean Difference|-25.3|STANDARD_ERROR_OF_MEAN|3.74|<|0.0001|TWO_SIDED|95.0|-32.62|-17.95|||ANCOVA|P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable.||Percent change from Baseline in SCORAD score at Week 8||-17.95|-32.62|< 0.0001
72329950|NCT03745638|144185276|SUPERIORITY||Least Squares Mean Difference|-30.4|STANDARD_ERROR_OF_MEAN|3.72|<|0.0001|TWO_SIDED|95.0|-37.68|-23.06|||ANCOVA|P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable.||Percent change from Baseline in SCORAD score at Week 8||-23.06|-37.68|< 0.0001
72329951|NCT03745638|144185277|SUPERIORITY||Least Squares Mean Difference|-1.39|STANDARD_ERROR_OF_MEAN|0.24|<|0.0001|TWO_SIDED|95.0|-1.87|-0.91|||Mixed-Model with Repeated Measures|The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.||Change from Baseline in Itch NRS score at Week 2||-0.91|-1.87|<0.0001
72329952|NCT03745638|144185277|SUPERIORITY||Least Squares Mean Difference|-1.64|STANDARD_ERROR_OF_MEAN|0.24|<|0.0001|TWO_SIDED|95.0|-2.11|-1.16|||Mixed-Model with Repeated Measures|The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.||Change from Baseline in Itch NRS score at Week 2||-1.16|-2.11|<0.0001
72329953|NCT03745638|144185277|SUPERIORITY||Least Squares Mean Difference|-1.7|STANDARD_ERROR_OF_MEAN|0.28|<|0.0001|TWO_SIDED|95.0|-2.25|-1.15|||Mixed-Model with Repeated Measures|The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.||Change from Baseline in Itch NRS score at Week 4||-1.15|-2.25|<0.0001
72329954|NCT03745638|144185277|SUPERIORITY||Least Squares Mean Difference|-2.08|STANDARD_ERROR_OF_MEAN|0.28|<|0.0001|TWO_SIDED|95.0|-2.63|-1.53|||Mixed-Model with Repeated Measures|The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.||Change from Baseline in Itch NRS score at Week 4||-1.53|-2.63|<0.0001
72329955|NCT03745638|144185277|SUPERIORITY||Least Squares Mean Difference|-1.6|STANDARD_ERROR_OF_MEAN|0.3|<|0.0001|TWO_SIDED|95.0|-2.2|-1.01|||Mixed-Model with Repeated Measures|The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.||Change from Baseline in Itch NRS score at Week 8||-1.01|-2.20|<0.0001
72329956|NCT03745638|144185277|SUPERIORITY||Least Squares Mean Difference|-1.99|STANDARD_ERROR_OF_MEAN|0.3|<|0.0001|TWO_SIDED|95.0|-2.58|-1.4|||Mixed-Model with Repeated Measures|The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.||Change from Baseline in Itch NRS score at Week 8||-1.40|-2.58|<0.0001
72329957|NCT03745638|144185279|SUPERIORITY||Least Squares Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|0.25|<|0.0001|TWO_SIDED|95.0|-1.74|-0.74|||ANCOVA|P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable.||Change from Baseline in Skin Pain NRS score at Week 8||-0.74|-1.74|<0.0001
72329958|NCT03745638|144185279|SUPERIORITY||Least Squares Mean Difference|-1.6|STANDARD_ERROR_OF_MEAN|0.25|<|0.0001|TWO_SIDED|95.0|-2.11|-1.13|||ANCOVA|P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable.||Change from Baseline in Skin Pain NRS score at Week 8||-1.13|-2.11|<0.0001
72329959|NCT03745638|144185282|SUPERIORITY||Least Squares Mean Difference|-1.53|STANDARD_ERROR_OF_MEAN|0.54||0.0049|TWO_SIDED|95.0|-2.6|-0.47|||Mixed-Model with Repeated Measures|The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.||Change from Baseline in PROMIS Short Form-Sleep Disturbance (8b) 24-hour recall score at Week 2||-0.47|-2.60|0.0049
72329960|NCT03745638|144185282|SUPERIORITY||Least Squares Mean Difference|-2.31|STANDARD_ERROR_OF_MEAN|0.54|<|0.0001|TWO_SIDED|95.0|-3.37|-1.25|||Mixed-Model with Repeated Measures|The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.||Change from Baseline in PROMIS Short Form-Sleep Disturbance (8b) 24-hour recall score at Week 2||-1.25|-3.37|<0.0001
72329961|NCT03745638|144185282|SUPERIORITY||Least Squares Mean Difference|-2.33|STANDARD_ERROR_OF_MEAN|0.6||0.0001|TWO_SIDED|95.0|-3.52|-1.15|||Mixed-Model with Repeated Measures|The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.||Change from Baseline in PROMIS Short Form-Sleep Disturbance (8b) 24-hour recall score at Week 4||-1.15|-3.52|0.0001
72329962|NCT03745638|144185282|SUPERIORITY||Least Squares Mean Difference|-2.85|STANDARD_ERROR_OF_MEAN|0.6|<|0.0001|TWO_SIDED|95.0|-4.03|-1.67|||Mixed-Model with Repeated Measures|The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.||Change from Baseline in PROMIS Short Form-Sleep Disturbance (8b) 24-hour recall score at Week 4||-1.67|-4.03|<0.0001
72329963|NCT03745638|144185282|SUPERIORITY||Least Squares Mean Difference|-2.54|STANDARD_ERROR_OF_MEAN|0.71||0.0004|TWO_SIDED|95.0|-3.93|-1.14|||Mixed-Model with Repeated Measures|The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.||Change from Baseline in PROMIS Short Form-Sleep Disturbance (8b) 24-hour recall score at Week 8||-1.14|-3.93|0.0004
72329964|NCT03745638|144185282|SUPERIORITY||Least Squares Mean Difference|-3.18|STANDARD_ERROR_OF_MEAN|0.71|<|0.0001|TWO_SIDED|95.0|-4.57|-1.79|||Mixed-Model with Repeated Measures|The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.||Change from Baseline in PROMIS Short Form-Sleep Disturbance (8b) 24-hour recall score at Week 8||-1.79|-4.57|<0.0001
72329965|NCT03745638|144185283|SUPERIORITY||Least Squares Mean Difference|-1.18|STANDARD_ERROR_OF_MEAN|0.6||0.0487|TWO_SIDED|95.0|-2.35|-0.01|||Mixed-Model with Repeated Measures|The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.||Change from Baseline in PROMIS Short Form - Sleep-Related Impairment (8a) 24-hour recall score at Week 2||-0.01|-2.35|0.0487
72329966|NCT03745638|144185283|SUPERIORITY||Least Squares Mean Difference|-1.68|STANDARD_ERROR_OF_MEAN|0.59||0.0049|TWO_SIDED|95.0|-2.84|-0.51|||Mixed-Model with Repeated Measures|The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.||Change from Baseline in PROMIS Short Form - Sleep-Related Impairment (8a) 24-hour recall score at Week 2||-0.51|-2.84|0.0049
72329967|NCT03745638|144185283|SUPERIORITY||Least Squares Mean Difference|-1.64|STANDARD_ERROR_OF_MEAN|0.66||0.0128|TWO_SIDED|95.0|-2.94|-0.35|||Mixed-Model with Repeated Measures|The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.||Change from Baseline in PROMIS Short Form - Sleep-Related Impairment (8a) 24-hour recall score at Week 4||-0.35|-2.94|0.0128
72329968|NCT03745638|144185283|SUPERIORITY||Least Squares Mean Difference|-1.91|STANDARD_ERROR_OF_MEAN|0.66||0.0037|TWO_SIDED|95.0|-3.2|-0.62|||Mixed-Model with Repeated Measures|The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.||Change from Baseline in PROMIS Short Form - Sleep-Related Impairment (8a) 24-hour recall score at Week 4||-0.62|-3.20|0.0037
72329969|NCT03745638|144185283|SUPERIORITY||Least Squares Mean Difference|-2.11|STANDARD_ERROR_OF_MEAN|0.75||0.0048|TWO_SIDED|95.0|-3.58|-0.65|||Mixed-Model with Repeated Measures|The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.||Change from Baseline in PROMIS Short Form - Sleep-Related Impairment (8a) 24-hour recall score at Week 8||-0.65|-3.58|0.0048
72329970|NCT03745638|144185283|SUPERIORITY||Least Squares Mean Difference|-2.3|STANDARD_ERROR_OF_MEAN|0.74||0.002|TWO_SIDED|95.0|-3.75|-0.84|||Mixed-Model with Repeated Measures|The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.||Change from Baseline in PROMIS Short Form - Sleep-Related Impairment (8a) 24-hour recall score at Week 8||-0.84|-3.75|0.0020
72329971|NCT03745638|144185286|SUPERIORITY||Least Squares Mean Difference|-3.1|STANDARD_ERROR_OF_MEAN|0.48|<|0.0001|TWO_SIDED|95.0|-4.07|-2.18|||ANCOVA|P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable.||Change from Baseline in %BSA at Week 8||-2.18|-4.07|<0.0001
72329972|NCT03745638|144185286|SUPERIORITY||Least Squares Mean Difference|-3.7|STANDARD_ERROR_OF_MEAN|0.48|<|0.0001|TWO_SIDED|95.0|-4.67|-2.79|||ANCOVA|P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable.||Change from Baseline in %BSA at Week 8||-2.79|-4.67|<0.0001
72329973|NCT03745638|144185288|SUPERIORITY||Least Squares Mean Difference|-5.1|STANDARD_ERROR_OF_MEAN|0.67|<|0.0001|TWO_SIDED|95.0|-6.43|-3.8|||ANCOVA|P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable.||Change from Baseline in POEM score at Week 8||-3.80|-6.43|<0.0001
72329974|NCT03745638|144185288|SUPERIORITY||Least Squares Mean Difference|-6.3|STANDARD_ERROR_OF_MEAN|0.67|<|0.0001|TWO_SIDED|95.0|-7.62|-5.0|||ANCOVA|P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable.||Change from Baseline in POEM score at Week 8||-5.00|-7.62|<0.0001
72329975|NCT03745638|144185290|SUPERIORITY||Least Squares Mean Difference|-3.8|STANDARD_ERROR_OF_MEAN|0.55|<|0.0001|TWO_SIDED|95.0|-4.85|-2.68|||ANCOVA|P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable.||Change from Baseline in total DLQI score at Week 8||-2.68|-4.85|<0.0001
72329976|NCT03745638|144185290|SUPERIORITY||Least Squares Mean Difference|-4.5|STANDARD_ERROR_OF_MEAN|0.55|<|0.0001|TWO_SIDED|95.0|-5.56|-3.42|||ANCOVA|P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable.||Change from Baseline in total DLQI score at Week 8||-3.42|-5.56|<0.0001
72329977|NCT03745638|144185292|SUPERIORITY||Least Squares Mean Difference|-3.3|STANDARD_ERROR_OF_MEAN|1.01||0.0018|TWO_SIDED|95.0|-5.29|-1.26|||ANCOVA|P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable.||Change from Baseline in total CDLQI score at Week 8||-1.26|-5.29|0.0018
72329978|NCT03745638|144185292|SUPERIORITY||Least Squares Mean Difference|-2.3|STANDARD_ERROR_OF_MEAN|1.08||0.0378|TWO_SIDED|95.0|-4.43|-0.13|||ANCOVA|P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable.||Change from Baseline in total CDLQI score at Week 8||-0.13|-4.43|0.0378
72329979|NCT03745638|144185296|SUPERIORITY||Odds Ratio (OR)|6.28|||<|0.0001|TWO_SIDED|95.0|3.632|11.018||The unadjusted p-values between each treatment group and vehicle were calculated based on Exact Logistic Regression including treatment and stratification factors to test the treatment difference.|Exact Logistic Regression|||Percentage of participants with a score of either 1 or 2 on the PGIC at Week 8||11.018|3.632|<0.0001
72329980|NCT03745638|144185296|SUPERIORITY||Odds Ratio (OR)|8.39|||<|0.0001|TWO_SIDED|95.0|4.755|15.083||The unadjusted p-values between each treatment group and vehicle were calculated based on Exact Logistic Regression including treatment and stratification factors to test the treatment difference.|Exact Logistic Regression|||Percentage of participants with a score of either 1 or 2 on the PGIC at Week 8||15.083|4.755|<0.0001
72329981|NCT03745638|144185297|SUPERIORITY||Least Squares Mean Difference|4.9|STANDARD_ERROR_OF_MEAN|1.67||0.0037|TWO_SIDED|95.0|1.59|8.15|||ANCOVA|P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable.||Change from Baseline in EQ VAS score at Week 8||8.15|1.59|0.0037
72421666|NCT04858802|144354606|SUPERIORITY||Mean Difference (Net)|4.19|STANDARD_DEVIATION|19.08||0.059|TWO_SIDED|95.0|-0.2|8.6||Paired; the threshold for statistical significance was p = 0.05.|t-test, 2 sided||Difference = PROPEL Contour Sinus Implant mean FSO cross-sectional area minus balloon sinus dilation alone mean FSO cross-sectional area|The null hypothesis was that there would no difference in FSO cross-sectional area between treatment and control sides at Day 45.||8.6|-0.2|0.059
72421667|NCT04858802|144354607|SUPERIORITY||Mean Difference (Final Values)|1.48|STANDARD_DEVIATION|12.98||0.328|TWO_SIDED|95.0|-1.5|4.5||Paired; the threshold for statistical significance was p = 0.05.|t-test, 2 sided||Difference = PROPEL Contour Sinus Implant mean FSO cross-sectional area change from baseline to Day 45 minus balloon sinus dilation alone mean FSO cross-sectional area change from baseline to Day 45|Day 45||4.5|-1.5|0.328
72421668|NCT04858802|144354607|SUPERIORITY||Mean Difference (Final Values)|-2.75|STANDARD_DEVIATION|12.64||0.063|TWO_SIDED|95.0|-5.7|0.2||Paired; the threshold for statistical significance was p = 0.05.|t-test, 2 sided||Difference = PROPEL Contour Sinus Implant mean FSO cross-sectional area change from baseline to Day 180 minus balloon sinus dilation alone mean FSO cross-sectional area change from baseline to Day 180|Day 180||0.2|-5.7|0.063
72421669|NCT04858802|144354608|SUPERIORITY||Mean Difference (Final Values)|50.94|STANDARD_DEVIATION|430.8||0.306|TWO_SIDED|95.0|-47.5|149.4||Paired; the threshold for statistical significance was p = 0.05.|t-test, 2 sided||Difference = PROPEL Contour Sinus Implant mean FSOT volume minus balloon sinus dilation alone mean FSOT volume|Day 45||149.4|-47.5|0.306
72421670|NCT04858802|144354608|SUPERIORITY||Mean Difference (Final Values)|-27.44|STANDARD_DEVIATION|413.22||0.567|TWO_SIDED|95.0|-122.5|67.6|||t-test, 2 sided|Paired; the threshold for statistical significance was p = 0.05.|Difference = PROPEL Contour Sinus Implant mean FSOT volume minus balloon sinus dilation alone mean FSOT volume|Day 180||67.6|-122.5|0.567
72421671|NCT04858802|144354609|SUPERIORITY||Mean Difference (Net)|0.48|STANDARD_DEVIATION|1.92||0.031|TWO_SIDED|95.0|0.0|0.9||Paired; the threshold for statistical significance was p = 0.05.|t-test, 2 sided||Difference = PROPEL Contour Sinus Implant mean FSO minimum diameter minus balloon sinus dilation alone mean FSO minimum diameter|Day 45||0.9|0.0|0.031
72329982|NCT03745638|144185297|SUPERIORITY||Least Squares Mean Difference|5.7|STANDARD_ERROR_OF_MEAN|1.66||0.0006|TWO_SIDED|95.0|2.45|8.96|||ANCOVA|P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable.||Change from Baseline in EQ VAS score at Week 8||8.96|2.45|0.0006
72329983|NCT03745638|144185298|SUPERIORITY||Least Squares Mean Difference|-4.9|STANDARD_ERROR_OF_MEAN|3.34||0.1417|TWO_SIDED|95.0|-11.49|1.65|||ANCOVA|P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable.||Percent work time missed due to AD: Change from Baseline in WPAI-SHP v2.0 at Week 8||1.65|-11.49|0.1417
72329984|NCT03745638|144185298|SUPERIORITY||Least Squares Mean Difference|-1.7|STANDARD_ERROR_OF_MEAN|3.29||0.6037|TWO_SIDED|95.0|-8.19|4.77|||ANCOVA|P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable.||Percent work time missed due to AD: Change from Baseline in WPAI-SHP v2.0 at Week 8||4.77|-8.19|0.6037
72329985|NCT03745638|144185298|SUPERIORITY||Least Squares Mean Difference|-11.0|STANDARD_ERROR_OF_MEAN|2.99||0.0003|TWO_SIDED|95.0|-16.89|-5.12|||ANCOVA|P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable.||Percent impairment while working due to AD: Change from Baseline in WPAI-SHP v2.0 at Week 8||-5.12|-16.89|0.0003
72329986|NCT03745638|144185298|SUPERIORITY||Least Squares Mean Difference|-12.2|STANDARD_ERROR_OF_MEAN|2.93|<|0.0001|TWO_SIDED|95.0|-17.98|-6.47|||ANCOVA|P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable.||Percent impairment while working due to AD: Change from Baseline in WPAI-SHP v2.0 at Week 8||-6.47|-17.98|<0.0001
72329987|NCT03745638|144185298|SUPERIORITY||Least Squares Mean Difference|-15.4|STANDARD_ERROR_OF_MEAN|3.85|<|0.0001|TWO_SIDED|95.0|-22.95|-7.81|||ANCOVA|P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable.||Percent overall work impairment due to AD: Change from Baseline in WPAI-SHP v2.0 at Week 8||-7.81|-22.95|<0.0001
72329988|NCT03745638|144185298|SUPERIORITY||Least Squares Mean Difference|-12.4|STANDARD_ERROR_OF_MEAN|3.77||0.0011|TWO_SIDED|95.0|-19.85|-5.01|||ANCOVA|P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable.||Percent overall work impairment due to AD: Change from Baseline in WPAI-SHP v2.0 at Week 8||-5.01|-19.85|0.0011
72329989|NCT03745638|144185298|SUPERIORITY||Least Squares Mean Difference|-10.5|STANDARD_ERROR_OF_MEAN|2.13|<|0.0001|TWO_SIDED|95.0|-14.64|-6.29|||ANCOVA|P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable.||Percent activity impairment due to AD: Change from Baseline in WPAI-SHP v2.0 at Week 8||-6.29|-14.64|<0.0001
72329990|NCT03745638|144185298|SUPERIORITY||Least Squares Mean Difference|-12.4|STANDARD_ERROR_OF_MEAN|2.12|<|0.0001|TWO_SIDED|95.0|-16.6|-8.29|||ANCOVA|P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable.||Percent activity impairment due to AD: Change from Baseline in WPAI-SHP v2.0 at Week 8||-8.29|-16.60|<0.0001
72329991|NCT01032603|144185302|SUPERIORITY||Difference in percentage of participants|9.0||||0.24|TWO_SIDED|95.0|-6.0|23.0|||Z test||Proportion of participants meeting criteria was obtained by Kaplan-Meier method. BLR group=46%, RR group=37%. Probability was compared b/w groups using Z test. A group difference and 95% CI were calculated. Positive differences favor the RR group.|||23|-6|0.24
72329992|NCT01032603|144185303|SUPERIORITY||Difference in percentage of participants|8.0||||0.25|TWO_SIDED|95.0|-6.0|21.0|||Z test||Proportion of participants meeting criteria was obtained by Kaplan-Meier method. BLR group=34%, RR group=26%. Probability was compared b/w groups using Z test. A group difference and 95% CI were calculated. Positive differences favor the RR group.|||21|-6|0.25
72329993|NCT01032603|144185304|SUPERIORITY||Difference in percentage of participants|-7.0||||0.06|TWO_SIDED|95.0|-14.0|0.23|||Z test||Proportion of participants meeting criteria was obtained by Kaplan-Meier method. BLR group=3%, RR group=10%. Probability was compared b/w groups using Z test. A group difference and 95% CI were calculated. Positive differences favor the RR group.|||0.23|-14|0.06
72421672|NCT04858802|144354609|SUPERIORITY||Mean Difference (Final Values)|0.02|STANDARD_DEVIATION|2.27||0.943|TWO_SIDED|95.0|-0.5|0.5||Paired; the threshold for statistical significance was p = 0.05.|t-test, 2 sided||Difference = PROPEL Contour Sinus Implant mean FSO minimum diameter minus balloon sinus dilation alone mean FSO minimum diameter|Day 180||0.5|-0.5|0.943
72421673|NCT04858802|144354610|SUPERIORITY||Mean Difference (Final Values)|-0.05|STANDARD_DEVIATION|1.24||0.715|TWO_SIDED|95.0|-0.3|0.2|||t-test, 2 sided||Difference = PROPEL Contour Sinus Implant mean Zinreich's modified Lund-Mackay score for the frontal sinus minus balloon sinus dilation alone mean Zinreich's modified Lund-Mackay score for the frontal sinus|Day 45||0.2|-0.3|0.715
72421674|NCT04858802|144354610|SUPERIORITY||Mean Difference (Final Values)|0.17|STANDARD_DEVIATION|0.96||0.129|TWO_SIDED|95.0|0.0|0.4|||t-test, 2 sided||Difference = PROPEL Contour Sinus Implant mean Zinreich's modified Lund-Mackay score for the frontal sinus minus balloon sinus dilation alone mean Zinreich's modified Lund-Mackay score for the frontal sinus|Day 180||0.4|0.0|0.129
72329994|NCT01032603|144185305|SUPERIORITY||Difference in percentage of participants|4.0||||0.36|TWO_SIDED|95.0|-5.0|14.0|||Z test||Proportion of participants meeting criteria by 3 yrs was obtained by KM method. BLR group=14%, RR group=10%. Probability was compared b/w groups using Z test. A group difference and 95% CI were calculated. Positive differences favor the RR group.|||14|-5|0.36
72329995|NCT01032603|144185307|SUPERIORITY|||||||0.44|||||||ANOVA|||3-year control outcomes were analyzed as continuous variables and compared between treatment groups using analysis of covariance (ANOVA) models that adjust for the corresponding baseline value (e.g. ANCOVA model of 3-year distance control will adjust for baseline distance control).||||0.44
72329996|NCT01032603|144185310|SUPERIORITY|||||||0.64|||||||ANOVA|||3-year control outcomes were analyzed as continuous variables and compared between treatment groups using analysis of covariance (ANOVA) models that adjust for the corresponding baseline value (e.g. ANCOVA model of 3-year near control will adjust for baseline near control).||||0.64
72329997|NCT01032603|144185313|SUPERIORITY|||||||0.21|||||||ANOVA|||3-year PACT outcomes were analyzed as continuous variables and compared between treatment groups using analysis of covariance (ANOVA) models that adjust for the corresponding baseline value.||||0.21
72329998|NCT01032603|144185316|SUPERIORITY|||||||0.38|||||||ANOVA|||3-year PACT outcomes were analyzed as continuous variables and compared between treatment groups using analysis of covariance (ANOVA) models that adjust for the corresponding baseline value.||||0.38
72329999|NCT01032603|144185319|SUPERIORITY|||||||0.93|||||||ANOVA|||3-year stereoacuity outcomes were analyzed as continuous variables and compared between treatment groups using analysis of covariance (ANOVA) models that adjust for the corresponding baseline value.||||0.93
72330000|NCT01032603|144185322|SUPERIORITY|||||||0.82|||||||ANOVA|||3-year stereoacuity outcomes were analyzed as continuous variables and compared between treatment groups using analysis of covariance (ANOVA) models that adjust for the corresponding baseline value.||||0.82
72330001|NCT01032603|144185324|SUPERIORITY|||||||0.3||||||Child 5 to 7 years old|Wilcoxon (Mann-Whitney)|||For the each of the two age-specific versions of the child IXTQ, the proxy questionnaire, and for each of the three parent questionnaire subscales, mean Rasch-based HRQOL scores at 3 years were compared between treatment groups using the Wilcoxon rank sum test.||||0.30
72330002|NCT01032603|144185324|SUPERIORITY|||||||0.77||||||Child 8 to 13 years old|Wilcoxon (Mann-Whitney)|||For the each of the two age-specific versions of the child IXTQ, the proxy questionnaire, and for each of the three parent questionnaire subscales, mean Rasch-based HRQOL scores9, 10 at 3 years were compared between treatment groups using the Wilcoxon rank sum test.||||0.77
72330003|NCT01032603|144185324|SUPERIORITY|||||||0.51||||||Parent Proxy IXTQ|Wilcoxon (Mann-Whitney)|||For the each of the two age-specific versions of the child IXTQ, the proxy questionnaire, and for each of the three parent questionnaire subscales, mean Rasch-based HRQOL scores9, 10 at 3 years were compared between treatment groups using the Wilcoxon rank sum test.||||0.51
72330004|NCT01032603|144185324|SUPERIORITY|||||||0.42||||||Parent Psychosocial|Wilcoxon (Mann-Whitney)|||For the each of the two age-specific versions of the child IXTQ, the proxy questionnaire, and for each of the three parent questionnaire subscales, mean Rasch-based HRQOL scores9, 10 at 3 years were compared between treatment groups using the Wilcoxon rank sum test.||||0.42
72330005|NCT01032603|144185324|SUPERIORITY|||||||0.68||||||Parent Function|Wilcoxon (Mann-Whitney)|||For the each of the two age-specific versions of the child IXTQ, the proxy questionnaire, and for each of the three parent questionnaire subscales, mean Rasch-based HRQOL scores9, 10 at 3 years were compared between treatment groups using the Wilcoxon rank sum test.||||0.68
72330006|NCT01032603|144185324|SUPERIORITY|||||||0.64||||||Parent Surgical|Wilcoxon (Mann-Whitney)|||For the each of the two age-specific versions of the child IXTQ, the proxy questionnaire, and for each of the three parent questionnaire subscales, mean Rasch-based HRQOL scores9, 10 at 3 years were compared between treatment groups using the Wilcoxon rank sum test.||||0.64
72421675|NCT04858802|144354611|SUPERIORITY||Odds Ratio (OR)|1.0||||1|TWO_SIDED|95.0|0.28|3.6||Paired; the threshold for statistical significance was p = 0.05.|t-test, 2 sided|||Day 21||3.60|0.28|1.00
72330007|NCT01032603|144185325|SUPERIORITY||Difference in percentage|5.0|||||TWO_SIDED|95.0|-2.0|13.0||||||"The cumulative proportion of participants with re-operation by 3 years was obtained using the Kaplan-Meier (K-M) method.~A treatment-group difference and a corresponding 95% confidence interval were calculated.~Treatment-group differences were calculated as BLR minus RR."||13|-2|
72330008|NCT01032603|144185326|SUPERIORITY||Difference in percentage of participants|-15.0|||||TWO_SIDED|95.0|-30.0|-0.0003||||||All treatment-group differences were calculated as the BLRc group minus the R\&R group. A treatment-group difference and a corresponding 95% confidence interval were calculated.||-.0003|-30|
72330009|NCT01032603|144185327|SUPERIORITY||Difference in percentage of participants|12.0|||||TWO_SIDED|95.0|-1.0|25.0||||||The proportion of participants with suboptimal surgical outcome at 3 years was compared between treatment groups using Barnard's exact test, and an exact 95% CI on the treatment-group difference was calculated using Farrington-Manning scores.||25|-1|
72330010|NCT01104545|144185355|OTHER||Geometric mean ratio (GMR)|1.0|||||||||||||GMR = Fed/Fasted|||||
72330011|NCT01104545|144185356|OTHER||GMR|0.73|||||||||||||GMR = Fed/fasted|||||
72330012|NCT02168062|144185396|OTHER|||||||0.109|||||||Wilcoxon (Mann-Whitney)|||||||0.109
72330013|NCT02168062|144185398|OTHER|||||||0.85|||||||Wilcoxon (Mann-Whitney)|||Systolic Blood Pressure measurement comparison||||0.85
72330014|NCT02168062|144185398|OTHER|||||||0.1|||||||Wilcoxon (Mann-Whitney)|||Diastolic Blood Pressure measurement comparison||||0.10
72330015|NCT02168062|144185399|OTHER|||||||0.7|||||||Wilcoxon (Mann-Whitney)|||Weight measurement comparison||||0.70
72330016|NCT02168062|144185400|OTHER|||||||0.11|||||||Wilcoxon (Mann-Whitney)|||Percentage body fat measurement comparison||||0.11
72330017|NCT02168062|144185401|OTHER|||||||0.32|||||||Wilcoxon (Mann-Whitney)|||Waist measurement comparison||||0.32
72330018|NCT02168062|144185402|OTHER|||||||0.7|||||||Wilcoxon (Mann-Whitney)|||Hemoglobin A1C measurement comparison||||0.70
72330019|NCT02168062|144185403|OTHER|||||||0.46|||||||Wilcoxon (Mann-Whitney)|||Insulin resistance score comparison||||0.46
72330020|NCT02168062|144185404|OTHER|||||||0.44|||||||Wilcoxon (Mann-Whitney)|||Total Cholesterol measurement comparison||||0.44
72330021|NCT02168062|144185404|OTHER|||||||0.52|||||||Wilcoxon (Mann-Whitney)|||Total low density lipid measurement comparison||||0.52
72330022|NCT02168062|144185404|OTHER|||||||0.4|||||||Wilcoxon (Mann-Whitney)|||Total high density lipid measurement comparison||||0.40
72330023|NCT02168062|144185404|OTHER|||||||0.53|||||||Wilcoxon (Mann-Whitney)|||Total triglyceride measurement comparison||||0.53
72330024|NCT02168062|144185405|OTHER|||||||0.38|||||||Wilcoxon (Mann-Whitney)|||Non-vigorous physical activity comparison||||0.38
72330025|NCT02168062|144185405|OTHER|||||||0.979|||||||Wilcoxon (Mann-Whitney)|||Moderate physical activity comparison||||0.979
72330026|NCT02168062|144185405|OTHER|||||||0.884|||||||Wilcoxon (Mann-Whitney)|||Moderate-Vigorous physical activity comparison||||0.884
72330027|NCT02168062|144185405|OTHER|||||||0.678|||||||Wilcoxon (Mann-Whitney)|||Vigorous physical activity comparison||||0.678
72330028|NCT02168062|144185405|OTHER|||||||0.464|||||||Wilcoxon (Mann-Whitney)|||Total physical activity comparison||||0.464
72330029|NCT02168062|144185406|OTHER|||||||0.838|||||||Wilcoxon (Mann-Whitney)|||Average MVPA Minutes per Day Comparison||||0.838
72330030|NCT02168062|144185407|OTHER|||||||0.677|||||||Wilcoxon (Mann-Whitney)|||Bone Density at the lumbar spine comparison||||0.677
72330031|NCT02168062|144185407|OTHER|||||||0.493|||||||Wilcoxon (Mann-Whitney)|||Bone Density at the femoral neck comparison||||0.493
72330032|NCT02168062|144185407|OTHER|||||||0.807|||||||Wilcoxon (Mann-Whitney)|||Bone Density of the total hip comparison||||0.807
72330033|NCT02168062|144185408|OTHER|||||||0.403|||||||Wilcoxon (Mann-Whitney)|||Serum 25-(OH) vitamin D level comparison||||0.403
72330034|NCT02168062|144185409|OTHER|||||||0.385|||||||Wilcoxon (Mann-Whitney)|||||||.385
72330035|NCT02168062|144185410|OTHER|||||||0.148|||||||Wilcoxon (Mann-Whitney)|||Attention Function Index (AFI) Score Comparison||||.148
72330036|NCT02168062|144185411|OTHER|||||||0.077|||||||Wilcoxon (Mann-Whitney)|||Mental Composite Score Comparison||||.077
72330037|NCT02168062|144185411|OTHER|||||||0.401|||||||Wilcoxon (Mann-Whitney)|||Physical Composite Score Comparison||||0.401
72330038|NCT02168062|144185412|OTHER|||||||0.085|||||||Wilcoxon (Mann-Whitney)|||||||0.085
72330039|NCT02168062|144185413|OTHER|||||||0.676|||||||Wilcoxon (Mann-Whitney)|||||||0.676
72330040|NCT02168062|144185414|OTHER|||||||0.183|||||||Wilcoxon (Mann-Whitney)|||||||0.183
72330041|NCT02168062|144185415|OTHER|||||||0.66|||||||Wilcoxon (Mann-Whitney)|||EPIC-26 Total Score Comparison||||0.66
72330042|NCT02168062|144185415|OTHER|||||||0.844|||||||Wilcoxon (Mann-Whitney)|||EPIC-26 Urinary Incontinence Score Comparison||||0.844
72330043|NCT02168062|144185415|OTHER|||||||0.175|||||||Wilcoxon (Mann-Whitney)|||EPIC-26 Urinary Irriation Score Comparison||||0.175
72330044|NCT02168062|144185415|OTHER|||||||0.472|||||||Wilcoxon (Mann-Whitney)|||EPIC-26 Bowel Function Score Comparison||||0.472
72330045|NCT02168062|144185415|OTHER|||||||0.405|||||||Wilcoxon (Mann-Whitney)|||EPIC-26 Sexual Function Score Comparison||||0.405
72330046|NCT02168062|144185415|OTHER|||||||0.749|||||||Wilcoxon (Mann-Whitney)|||EPIC-26 Hormonal Function Score Comparison||||0.749
72330047|NCT02168062|144185416|OTHER|||||||0.907|||||||Wilcoxon (Mann-Whitney)|||Fatigue Scale Score Comparison||||0.907
72330048|NCT02168062|144185416|OTHER|||||||0.792|||||||Wilcoxon (Mann-Whitney)|||Energy Scale Score Comparison||||0.792
72330049|NCT00923351|144185434|SUPERIORITY_OR_OTHER|||||||0.043|TWO_SIDED||||||Fisher Exact|||||||0.043
72330050|NCT00940290|144185437|SUPERIORITY_OR_OTHER|||||||0.007||95.0|||||Kruskal-Wallis|||After reading the clinical practice guideline, the median response from the four groups were compared using the Kruskal-Wallis statistic||||0.007
72330051|NCT02993822|144185462|SUPERIORITY||Mean Difference (Final Values)|1.14||||0.324|TWO_SIDED|95.0|0.88|1.49|||Mixed model repeated measures|||Change from baseline to each visit (Week 2, Week 4 and Week 12) in log transformed awake objective cough frequency was analysed using a mixed model for repeated measures (MMRM) with restricted maximum likelihood (REML) estimation. The treatment effect at Week 12 was estimated using the ratio of geometric means (i.e. the difference between the treatments least squares means \[adjusted means\] on the log scale, back transformed to the original scale).||1.49|0.88|0.324
72330052|NCT02993822|144185462|SUPERIORITY||Mean Difference (Final Values)|1.14||||0.332|TWO_SIDED|95.0|0.88|1.48|||Mixed model repeated measures|||Change from baseline to each visit (Week 2, Week 4 and Week 12) in log transformed awake objective cough frequency was analysed using a mixed model for repeated measures (MMRM) with restricted maximum likelihood (REML) estimation. The treatment effect at Week 12 was estimated using the ratio of geometric means (i.e. the difference between the treatments least squares means \[adjusted means\] on the log scale, back transformed to the original scale).||1.48|0.88|0.332
72330053|NCT02993822|144185462|SUPERIORITY||Mean Difference (Final Values)|0.92||||0.531|TWO_SIDED|95.0|0.71|1.2|||Mixed model repeated measures|||Change from baseline to each visit (Week 2, Week 4 and Week 12) in log transformed awake objective cough frequency was analysed using a mixed model for repeated measures (MMRM) with restricted maximum likelihood (REML) estimation. The treatment effect at Week 12 was estimated using the ratio of geometric means (i.e. the difference between the treatments least squares means \[adjusted means\] on the log scale, back transformed to the original scale).||1.20|0.71|0.531
72330054|NCT02993822|144185463|SUPERIORITY||Mean Difference (Final Values)|0.93||||0.482|TWO_SIDED|95.0|0.75|1.15|||Mixed model repeated measures|||Change from baseline to each visit (Week 2, Week 4 and Week 12) in log transformed awake objective cough frequency was analysed using a mixed model for repeated measures (MMRM) with restricted maximum likelihood (REML) estimation. The treatment effect at Week 12 was estimated using the ratio of geometric means (i.e. the difference between the treatments least squares means \[adjusted means\] on the log scale, back transformed to the original scale).||1.15|0.75|0.482
72330055|NCT02993822|144185463|SUPERIORITY||Mean Difference (Final Values)|0.92||||0.46|TWO_SIDED|95.0|0.75|1.14|||Mixed model repeated measures|||Change from baseline to each visit (Week 2, Week 4 and Week 12) in log transformed awake objective cough frequency was analysed using a mixed model for repeated measures (MMRM) with restricted maximum likelihood (REML) estimation. The treatment effect at Week 12 was estimated using the ratio of geometric means (i.e. the difference between the treatments least squares means \[adjusted means\] on the log scale, back transformed to the original scale).||1.14|0.75|0.460
72330056|NCT02993822|144185463|SUPERIORITY||Mean Difference (Final Values)|0.86||||0.144|TWO_SIDED|95.0|0.69|1.06|||Mixed model repeated measures|||Change from baseline to each visit (Week 2, Week 4 and Week 12) in log transformed awake objective cough frequency was analysed using a mixed model for repeated measures (MMRM) with restricted maximum likelihood (REML) estimation. The treatment effect at Week 12 was estimated using the ratio of geometric means (i.e. the difference between the treatments least squares means \[adjusted means\] on the log scale, back transformed to the original scale).||1.06|0.69|0.144
72330057|NCT02993822|144185464|SUPERIORITY||Mean Difference (Final Values)|1.0||||0.992|TWO_SIDED|95.0|0.78|1.27|||Mixed model repeated measures|||Change from baseline to each visit (Week 2, Week 4 and Week 12) in log transformed awake objective cough frequency was analysed using a mixed model for repeated measures (MMRM) with restricted maximum likelihood (REML) estimation. The treatment effect at Week 12 was estimated using the ratio of geometric means (i.e. the difference between the treatments least squares means \[adjusted means\] on the log scale, back transformed to the original scale).||1.27|0.78|0.992
72330058|NCT02993822|144185464|SUPERIORITY||Mean Difference (Final Values)|0.9||||0.387|TWO_SIDED|95.0|0.71|1.14|||Mixed model repeated measures|||Change from baseline to each visit (Week 2, Week 4 and Week 12) in log transformed awake objective cough frequency was analysed using a mixed model for repeated measures (MMRM) with restricted maximum likelihood (REML) estimation. The treatment effect at Week 12 was estimated using the ratio of geometric means (i.e. the difference between the treatments least squares means \[adjusted means\] on the log scale, back transformed to the original scale).||1.14|0.71|0.387
72330059|NCT02993822|144185464|SUPERIORITY||Mean Difference (Final Values)|0.94||||0.6|TWO_SIDED|95.0|0.74|1.19|||Mixed model repeated measures|||Change from baseline to each visit (Week 2, Week 4 and Week 12) in log transformed awake objective cough frequency was analysed using a mixed model for repeated measures (MMRM) with restricted maximum likelihood (REML) estimation. The treatment effect at Week 12 was estimated using the ratio of geometric means (i.e. the difference between the treatments least squares means \[adjusted means\] on the log scale, back transformed to the original scale).||1.19|0.74|0.600
72330060|NCT02993822|144185465|SUPERIORITY||Mean Difference (Final Values)|1.0||||0.042|TWO_SIDED|95.0|0.0|2.0|||Mixed model repeated measures|||"The change from baseline in LCQ total score and the three domain scores was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline.~The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in LCQ total score and the three domain scores was analysed using a MMRM with REML estimation."||2.0|0.0|0.042
72330061|NCT02993822|144185465|SUPERIORITY||Median Difference (Final Values)|1.1||||0.026|TWO_SIDED|95.0|0.1|2.0|||Mixed model repeated measures|||"The change from baseline in LCQ total score and the three domain scores was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline.~The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in LCQ total score and the three domain scores was analysed using a MMRM with REML estimation."||2.0|0.1|0.026
72330062|NCT02993822|144185465|SUPERIORITY||Mean Difference (Final Values)|1.4||||0.003|TWO_SIDED|95.0|0.5|2.4|||Mixed model repeated measures|||"The change from baseline in LCQ total score and the three domain scores was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline.~The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in LCQ total score and the three domain scores was analysed using a MMRM with REML estimation."||2.4|0.5|0.003
72330063|NCT02993822|144185466|SUPERIORITY||Mean Difference (Final Values)|0.6||||0.25|TWO_SIDED|95.0|-0.4|1.7|||Mixed model repeated measures|||"The change from baseline in LCQ total score and the three domain scores was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline.~The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in LCQ total score and the three domain scores was analysed using a MMRM with REML estimation."||1.7|-0.4|0.250
72330064|NCT02993822|144185466|SUPERIORITY||Mean Difference (Final Values)|0.5||||0.325|TWO_SIDED|95.0|-0.5|1.5|||Mixed model repeated measures|||"The change from baseline in LCQ total score and the three domain scores was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline.~The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in LCQ total score and the three domain scores was analysed using a MMRM with REML estimation."||1.5|-0.5|0.325
72330065|NCT02993822|144185466|SUPERIORITY||Mean Difference (Final Values)|1.1||||0.029|TWO_SIDED|95.0|0.1|2.2|||Mixed model repeated measures|||"The change from baseline in LCQ total score and the three domain scores was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline.~The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in LCQ total score and the three domain scores was analysed using a MMRM with REML estimation."||2.2|0.1|0.029
72330066|NCT02993822|144185467|SUPERIORITY||Mean Difference (Final Values)|1.2||||0.038|TWO_SIDED|95.0|0.1|2.3|||Mixed model repeated measures|||"The change from baseline in LCQ total score and the three domain scores was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline.~The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in LCQ total score and the three domain scores was analysed using a MMRM with REML estimation."||2.3|0.1|0.038
72330067|NCT02993822|144185467|SUPERIORITY||Mean Difference (Final Values)|0.9||||0.118|TWO_SIDED|95.0|-0.2|2.0|||Mixed model repeated measures|||"The change from baseline in LCQ total score and the three domain scores was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline.~The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in LCQ total score and the three domain scores was analysed using a MMRM with REML estimation."||2.0|-0.2|0.118
72330068|NCT02993822|144185467|SUPERIORITY||Mean Difference (Final Values)|1.3||||0.025|TWO_SIDED|95.0|0.2|2.4|||Mixed model repeated measures|||"The change from baseline in LCQ total score and the three domain scores was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline.~The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in LCQ total score and the three domain scores was analysed using a MMRM with REML estimation."||2.4|0.2|0.025
72421676|NCT04858802|144354611|SUPERIORITY||Odds Ratio (OR)|0.79||||0.453|TWO_SIDED|95.0|0.36|1.73||Paired; the threshold for statistical significance was p = 0.05.|t-test, 2 sided|||Day 45||1.73|0.36|0.453
72330069|NCT02993822|144185468|SUPERIORITY||Mean Difference (Final Values)|0.7||||0.258|TWO_SIDED|95.0|-0.5|1.9|||Mixed model repeated measures|||"The change from baseline in LCQ total score and the three domain scores was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline.~The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in LCQ total score and the three domain scores was analysed using a MMRM with REML estimation."||1.9|-0.5|0.258
72330070|NCT02993822|144185468|SUPERIORITY||Mean Difference (Final Values)|0.7||||0.243|TWO_SIDED|95.0|-0.5|1.8|||Mixed model repeated measures|||"The change from baseline in LCQ total score and the three domain scores was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline.~The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in LCQ total score and the three domain scores was analysed using a MMRM with REML estimation."||1.8|-0.5|0.243
72330071|NCT02993822|144185468|SUPERIORITY||Mean Difference (Final Values)|1.6||||0.009|TWO_SIDED|95.0|0.4|2.8|||Mixed model repeated measures|||"The change from baseline in LCQ total score and the three domain scores was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline.~The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in LCQ total score and the three domain scores was analysed using a MMRM with REML estimation."||2.8|0.4|0.009
72330072|NCT02993822|144185469|SUPERIORITY||Mean Difference (Final Values)|-9.6||||0.008|TWO_SIDED|95.0|-16.6|-2.5|||Mixed model repeated measures|||Change in the Cough Severity VAS was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline. The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in Cough Severity VAS was analysed using a MMRM with REML estimation.||-2.5|-16.6|0.008
72330073|NCT02993822|144185469|SUPERIORITY||Mean Difference (Final Values)|-4.5||||0.198|TWO_SIDED|95.0|-11.4|2.4|||Mixed model repeated measures|||Change in the Cough Severity VAS was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline. The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in Cough Severity VAS was analysed using a MMRM with REML estimation.||2.4|-11.4|0.198
72330074|NCT02993822|144185469|SUPERIORITY||Mean Difference (Final Values)|-6.8||||0.055|TWO_SIDED|95.0|-13.7|0.1|||Mixed model repeated measures|||Change in the Cough Severity VAS was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline. The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in Cough Severity VAS was analysed using a MMRM with REML estimation.||0.1|-13.7|0.055
72330075|NCT02993822|144185470|SUPERIORITY||Mean Difference (Final Values)|-8.7||||0.026|TWO_SIDED|95.0|-16.3|-1.1|||Mixed model repeated measures|||Change in the Cough Severity VAS was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline. The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in Cough Severity VAS was analysed using a MMRM with REML estimation.||-1.1|-16.3|0.026
72330076|NCT02993822|144185470|SUPERIORITY||Mean Difference (Final Values)|-2.1||||0.571|TWO_SIDED|95.0|-9.6|5.3|||Mixed model repeated measures|||Change in the Cough Severity VAS was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline. The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in Cough Severity VAS was analysed using a MMRM with REML estimation.||5.3|-9.6|0.571
72330077|NCT02993822|144185470|SUPERIORITY||Mean Difference (Final Values)|-7.7||||0.043|TWO_SIDED|95.0|-15.2|-0.3|||Mixed model repeated measures|||Change in the Cough Severity VAS was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline. The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in Cough Severity VAS was analysed using a MMRM with REML estimation.||-0.3|-15.2|0.043
72330078|NCT02993822|144185471|SUPERIORITY||Mean Difference (Final Values)|-11.5||||0.006|TWO_SIDED|95.0|-19.7|-3.3|||Mixed model repeated measures|||Change in the Cough Severity VAS was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline. The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in Cough Severity VAS was analysed using a MMRM with REML estimation.||-3.3|-19.7|0.006
72330079|NCT02993822|144185471|SUPERIORITY||Mean Difference (Final Values)|-3.1||||0.435|TWO_SIDED|95.0|-11.1|4.8|||Mixed model repeated measures|||Change in the Cough Severity VAS was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline. The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in Cough Severity VAS was analysed using a MMRM with REML estimation.||4.8|-11.1|0.435
72421677|NCT04858802|144354611|SUPERIORITY||Odds Ratio (OR)|0.71||||0.219|TWO_SIDED|95.0|0.31|1.61||Paired; the threshold for statistical significance was p = 0.05.|t-test, 2 sided|||Day 90||1.61|0.31|0.219
72330080|NCT02993822|144185471|SUPERIORITY||Mean Difference (Final Values)|-9.4||||0.022|TWO_SIDED|95.0|-17.4|-1.4|||Mixed model repeated measures|||Change in the Cough Severity VAS was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline. The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in Cough Severity VAS was analysed using a MMRM with REML estimation.||-1.4|-17.4|0.022
72330081|NCT02993822|144185472|SUPERIORITY||Mean Difference (Final Values)|-7.0||||0.103|TWO_SIDED|95.0|-15.3|1.4|||Mixed model repeated measures|||Change in the Cough Severity VAS was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline. The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in Cough Severity VAS was analysed using a MMRM with REML estimation.||1.4|-15.3|0.103
72330082|NCT02993822|144185472|SUPERIORITY||Mean Difference (Final Values)|-2.5||||0.546|TWO_SIDED|95.0|-10.6|5.6|||Mixed model repeated measures|||Change in the Cough Severity VAS was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline. The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in Cough Severity VAS was analysed using a MMRM with REML estimation.||5.6|-10.6|0.546
72330083|NCT02993822|144185472|SUPERIORITY||Mean Difference (Final Values)|-9.0||||0.034|TWO_SIDED|95.0|-17.2|-0.7|||Mixed model repeated measures|||Change in the Cough Severity VAS was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline. The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in Cough Severity VAS was analysed using a MMRM with REML estimation.||-0.7|-17.2|0.034
72330084|NCT02993822|144185473|SUPERIORITY||Mean Difference (Final Values)|-11.2||||0.004|TWO_SIDED|95.0|-18.8|-3.6|||Mixed model repeated measures|||Change in the Cough Severity VAS was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline. The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in Cough Severity VAS was analysed using a MMRM with REML estimation.||-3.6|-18.8|0.004
72330085|NCT02993822|144185473|SUPERIORITY||Mean Difference (Final Values)|-4.1||||0.282|TWO_SIDED|95.0|-11.5|3.4|||Mixed model repeated measures|||Change in the Cough Severity VAS was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline. The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in Cough Severity VAS was analysed using a MMRM with REML estimation.||3.4|-11.5|0.282
72330086|NCT02993822|144185473|SUPERIORITY||Mean Difference (Final Values)|-3.2||||0.398|TWO_SIDED|95.0|-10.7|4.3|||Mixed model repeated measures|||Change in the Cough Severity VAS was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline. The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in Cough Severity VAS was analysed using a MMRM with REML estimation.||4.3|-10.7|0.398
72330087|NCT02993822|144185474|SUPERIORITY||Mean Difference (Final Values)|-10.0||||0.019|TWO_SIDED|95.0|-18.3|-1.7|||Mixed model repeated measures|||Change in the Cough Severity VAS was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline. The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in Cough Severity VAS was analysed using a MMRM with REML estimation.||-1.7|-18.3|0.019
72330088|NCT02993822|144185474|SUPERIORITY||Mean Difference (Final Values)|-5.6||||0.17|TWO_SIDED|95.0|-13.7|2.4|||Mixed model repeated measures|||Change in the Cough Severity VAS was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline. The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in Cough Severity VAS was analysed using a MMRM with REML estimation.||2.4|-13.7|0.170
72330089|NCT02993822|144185474|SUPERIORITY||Mean Difference (Final Values)|-3.6||||0.384|TWO_SIDED|95.0|-11.7|4.5|||Mixed model repeated measures|||Change in the Cough Severity VAS was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline. The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in Cough Severity VAS was analysed using a MMRM with REML estimation.||4.5|-11.7|0.384
72330090|NCT02993822|144185475|SUPERIORITY||Mean Difference (Final Values)|-11.7||||0.006|TWO_SIDED|95.0|-20.0|-3.3|||Mixed model repeated measures|||Change in the Cough Severity VAS was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline. The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in Cough Severity VAS was analysed using a MMRM with REML estimation.||-3.3|-20.0|0.006
72330091|NCT02993822|144185475|SUPERIORITY||Mean Difference (Final Values)|-5.0||||0.222|TWO_SIDED|95.0|-13.0|3.0|||Mixed model repeated measures|||Change in the Cough Severity VAS was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline. The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in Cough Severity VAS was analysed using a MMRM with REML estimation.||3.0|-13.0|0.222
72330092|NCT02993822|144185475|SUPERIORITY||Mean Difference (Final Values)|-7.9||||0.058|TWO_SIDED|95.0|-16.0|0.3|||Mixed model repeated measures|||Change in the Cough Severity VAS was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline. The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in Cough Severity VAS was analysed using a MMRM with REML estimation.||0.3|-16.0|0.058
72330093|NCT02993822|144185476|SUPERIORITY||Mean Difference (Final Values)|-10.0||||0.027|TWO_SIDED|95.0|-18.9|-1.2|||Mixed model repeated measures|||Change in the Cough Severity VAS was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline. The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in Cough Severity VAS was analysed using a MMRM with REML estimation.||-1.2|-18.9|0.027
72330094|NCT02993822|144185476|SUPERIORITY||Mean Difference (Final Values)|-6.4||||0.147|TWO_SIDED|95.0|-14.9|2.2|||Mixed model repeated measures|||Change in the Cough Severity VAS was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline. The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in Cough Severity VAS was analysed using a MMRM with REML estimation.||2.2|-14.9|0.147
72421678|NCT04858802|144354611|SUPERIORITY||Odds Ratio (OR)|0.71||||0.289|TWO_SIDED|95.0|0.31|1.61|||t-test, 2 sided|||Day 180||1.61|0.31|0.289
72330095|NCT02993822|144185476|SUPERIORITY||Mean Difference (Final Values)|-8.9||||0.046|TWO_SIDED|95.0|-17.6|-0.1|||Mixed model repeated measures|||Change in the Cough Severity VAS was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline. The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in Cough Severity VAS was analysed using a MMRM with REML estimation.||-0.1|-17.6|0.046
72421679|NCT04858802|144354612|SUPERIORITY||Mean Difference (Final Values)|-0.09|STANDARD_DEVIATION|21.12||0.971|TWO_SIDED|95.0|-4.9|4.8||Paired; the threshold for statistical significance was p = 0.05.|t-test, 2 sided||Difference = PROPEL Contour Sinus Implant mean FSO cross-sectional area minus balloon sinus dilation alone mean FSO cross-sectional area|Day 180||4.8|-4.9|0.971
72330096|NCT02993822|144185477|SUPERIORITY||Mean Difference (Final Values)|-12.5|||<|0.001|TWO_SIDED|95.0|-19.5|-5.5|||Mixed model repeated measures|||Change in the urge-to-cough VAS was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline. The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in urge-to cough VAS was analysed using a MMRM with REML estimation.||-5.5|-19.5|<0.001
72330097|NCT02993822|144185477|SUPERIORITY||Mean Difference (Final Values)|-5.5||||0.114|TWO_SIDED|95.0|-12.4|1.3|||Mixed model repeated measures|||Change in the urge-to-cough VAS was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline. The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in urge-to cough VAS was analysed using a MMRM with REML estimation.||1.3|-12.4|0.114
72330098|NCT02993822|144185477|SUPERIORITY||Mean Difference (Final Values)|-6.8||||0.056|TWO_SIDED|95.0|-13.7|0.2|||Mixed model repeated measures|||Change in the urge-to-cough VAS was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline. The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in urge-to cough VAS was analysed using a MMRM with REML estimation.||0.2|-13.7|0.056
72330099|NCT02993822|144185478|SUPERIORITY||Mean Difference (Final Values)|-8.9||||0.027|TWO_SIDED|95.0|-16.8|-1.0|||Mixed model repeated measures|||Change in the urge-to-cough VAS was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline. The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in urge-to cough VAS was analysed using a MMRM with REML estimation.||-1.0|-16.8|0.027
72330100|NCT02993822|144185478|SUPERIORITY||Mean Difference (Final Values)|-3.6||||0.357|TWO_SIDED|95.0|-11.3|4.1|||Mixed model repeated measures|||Change in the urge-to-cough VAS was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline. The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in urge-to cough VAS was analysed using a MMRM with REML estimation.||4.1|-11.3|0.357
72330101|NCT02993822|144185478|SUPERIORITY||Mean Difference (Final Values)|-8.5||||0.031|TWO_SIDED|95.0|-16.2|-0.8|||Mixed model repeated measures|||Change in the urge-to-cough VAS was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline. The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in urge-to cough VAS was analysed using a MMRM with REML estimation.||-0.8|-16.2|0.031
72330102|NCT02993822|144185479|SUPERIORITY||Mean Difference (Final Values)|-11.1||||0.008|TWO_SIDED|95.0|-19.2|-2.9|||Mixed model repeated measures|||Change in the urge-to-cough VAS was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline. The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in urge-to cough VAS was analysed using a MMRM with REML estimation.||-2.9|-19.2|0.008
72330103|NCT02993822|144185479|SUPERIORITY||Mean Difference (Final Values)|-4.0||||0.321|TWO_SIDED|95.0|-11.8|3.9|||Mixed model repeated measures|||Change in the urge-to-cough VAS was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline. The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in urge-to cough VAS was analysed using a MMRM with REML estimation.||3.9|-11.8|0.321
72330104|NCT02993822|144185479|SUPERIORITY||Mean Difference (Final Values)|-8.1||||0.047|TWO_SIDED|95.0|-16.0|-0.1|||Mixed model repeated measures|||Change in the urge-to-cough VAS was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline. The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in urge-to cough VAS was analysed using a MMRM with REML estimation.||-0.1|-16.0|0.047
72330105|NCT02993822|144185480|SUPERIORITY||Mean Difference (Final Values)|-10.1||||0.018|TWO_SIDED|95.0|-18.4|-1.8|||Mixed model repeated measures|||Change in the urge-to-cough VAS was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline. The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in urge-to cough VAS was analysed using a MMRM with REML estimation.||-1.8|-18.4|0.018
72330106|NCT02993822|144185480|SUPERIORITY||Mean Difference (Final Values)|-1.7||||0.682|TWO_SIDED|95.0|-9.8|6.4|||Mixed model repeated measures|||Change in the urge-to-cough VAS was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline. The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in urge-to cough VAS was analysed using a MMRM with REML estimation.||6.4|-9.8|0.682
72330107|NCT02993822|144185480|SUPERIORITY||Mean Difference (Final Values)|-11.8||||0.005|TWO_SIDED|95.0|-20.0|-3.6|||Mixed model repeated measures|||Change in the urge-to-cough VAS was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline. The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in urge-to cough VAS was analysed using a MMRM with REML estimation.||-3.6|-20.0|0.005
72330108|NCT02993822|144185481|SUPERIORITY|||||||0.004|||||||Cochran-Mantel-Haenszel|||"The Global Rating of Change responses were summarised by treatment group and visit (Weeks 2, 4, 8 and 12) as categorical endpoints (worse, about the same and better). Pairwise comparisons were performed using the Cochran Mantel Haenszel test stratified by region using modified ridit scores (row mean scores differ)."||||0.004
72330109|NCT02993822|144185481|SUPERIORITY|||||||0.134|||||||Cochran-Mantel-Haenszel|||"The Global Rating of Change responses were summarised by treatment group and visit (Weeks 2, 4, 8 and 12) as categorical endpoints (worse, about the same and better). Pairwise comparisons were performed using the Cochran Mantel Haenszel test stratified by region using modified ridit scores (row mean scores differ)."||||0.134
72330110|NCT02993822|144185481|SUPERIORITY|||||||0.003|||||||Cochran-Mantel-Haenszel|||"The Global Rating of Change responses were summarised by treatment group and visit (Weeks 2, 4, 8 and 12) as categorical endpoints (worse, about the same and better). Pairwise comparisons were performed using the Cochran Mantel Haenszel test stratified by region using modified ridit scores (row mean scores differ)."||||0.003
72330111|NCT02993822|144185482|SUPERIORITY|||||||0.401|||||||Cochran-Mantel-Haenszel|||"The Global Rating of Change responses were summarised by treatment group and visit (Weeks 2, 4, 8 and 12) as categorical endpoints (worse, about the same and better). Pairwise comparisons were performed using the Cochran Mantel Haenszel test stratified by region using modified ridit scores (row mean scores differ)."||||0.401
72330112|NCT02993822|144185482|SUPERIORITY|||||||0.175|||||||Cochran-Mantel-Haenszel|||"The Global Rating of Change responses were summarised by treatment group and visit (Weeks 2, 4, 8 and 12) as categorical endpoints (worse, about the same and better). Pairwise comparisons were performed using the Cochran Mantel Haenszel test stratified by region using modified ridit scores (row mean scores differ)."||||0.175
72330113|NCT02993822|144185482|SUPERIORITY|||||||0.126|||||||Cochran-Mantel-Haenszel|||"The Global Rating of Change responses were summarised by treatment group and visit (Weeks 2, 4, 8 and 12) as categorical endpoints (worse, about the same and better). Pairwise comparisons were performed using the Cochran Mantel Haenszel test stratified by region using modified ridit scores (row mean scores differ)."||||0.126
72330114|NCT02993822|144185483|SUPERIORITY|||||||0.002|||||||Cochran-Mantel-Haenszel|||"The Global Rating of Change responses were summarised by treatment group and visit (Weeks 2, 4, 8 and 12) as categorical endpoints (worse, about the same and better). Pairwise comparisons were performed using the Cochran Mantel Haenszel test stratified by region using modified ridit scores (row mean scores differ)."||||0.002
72330115|NCT02993822|144185483|SUPERIORITY|||||||0.144|||||||Cochran-Mantel-Haenszel|||"The Global Rating of Change responses were summarised by treatment group and visit (Weeks 2, 4, 8 and 12) as categorical endpoints (worse, about the same and better). Pairwise comparisons were performed using the Cochran Mantel Haenszel test stratified by region using modified ridit scores (row mean scores differ)."||||0.144
72330116|NCT02993822|144185483|SUPERIORITY|||||||0.025|||||||Cochran-Mantel-Haenszel|||"The Global Rating of Change responses were summarised by treatment group and visit (Weeks 2, 4, 8 and 12) as categorical endpoints (worse, about the same and better). Pairwise comparisons were performed using the Cochran Mantel Haenszel test stratified by region using modified ridit scores (row mean scores differ)."||||0.025
72330117|NCT02993822|144185484|SUPERIORITY|||||||0.158|||||||Cochran-Mantel-Haenszel|||"The Global Rating of Change responses were summarised by treatment group and visit (Weeks 2, 4, 8 and 12) as categorical endpoints (worse, about the same and better). Pairwise comparisons were performed using the Cochran Mantel Haenszel test stratified by region using modified ridit scores (row mean scores differ)."||||0.158
72330118|NCT02993822|144185484|SUPERIORITY|||||||0.597|||||||Cochran-Mantel-Haenszel|||"The Global Rating of Change responses were summarised by treatment group and visit (Weeks 2, 4, 8 and 12) as categorical endpoints (worse, about the same and better). Pairwise comparisons were performed using the Cochran Mantel Haenszel test stratified by region using modified ridit scores (row mean scores differ)."||||0.597
72330119|NCT02993822|144185484|SUPERIORITY|||||||0.124|||||||Cochran-Mantel-Haenszel|||"The Global Rating of Change responses were summarised by treatment group and visit (Weeks 2, 4, 8 and 12) as categorical endpoints (worse, about the same and better). Pairwise comparisons were performed using the Cochran Mantel Haenszel test stratified by region using modified ridit scores (row mean scores differ)."||||0.124
72330120|NCT02993822|144185485|SUPERIORITY|||||||0.01|||||||Cochran-Mantel-Haenszel|||"The Global Rating of Change responses were summarised by treatment group and visit (Weeks 2, 4, 8 and 12) as categorical endpoints (worse, about the same and better). Pairwise comparisons were performed using the Cochran Mantel Haenszel test stratified by region using modified ridit scores (row mean scores differ)."||||0.01
72330121|NCT02993822|144185485|SUPERIORITY|||||||0.049|||||||Cochran-Mantel-Haenszel|||"The Global Rating of Change responses were summarised by treatment group and visit (Weeks 2, 4, 8 and 12) as categorical endpoints (worse, about the same and better). Pairwise comparisons were performed using the Cochran Mantel Haenszel test stratified by region using modified ridit scores (row mean scores differ)."||||0.049
72330122|NCT02993822|144185485|SUPERIORITY|||||||0.001|||||||Cochran-Mantel-Haenszel|||"The Global Rating of Change responses were summarised by treatment group and visit (Weeks 2, 4, 8 and 12) as categorical endpoints (worse, about the same and better). Pairwise comparisons were performed using the Cochran Mantel Haenszel test stratified by region using modified ridit scores (row mean scores differ)."||||0.001
72330123|NCT02993822|144185486|SUPERIORITY|||||||0.309|||||||Cochran-Mantel-Haenszel|||"The Global Rating of Change responses were summarised by treatment group and visit (Weeks 2, 4, 8 and 12) as categorical endpoints (worse, about the same and better). Pairwise comparisons were performed using the Cochran Mantel Haenszel test stratified by region using modified ridit scores (row mean scores differ)."||||0.309
72330124|NCT02993822|144185486|SUPERIORITY|||||||0.387|||||||Cochran-Mantel-Haenszel|||"The Global Rating of Change responses were summarised by treatment group and visit (Weeks 2, 4, 8 and 12) as categorical endpoints (worse, about the same and better). Pairwise comparisons were performed using the Cochran Mantel Haenszel test stratified by region using modified ridit scores (row mean scores differ)."||||0.387
72330125|NCT02993822|144185486|SUPERIORITY|||||||0.025|||||||Cochran-Mantel-Haenszel|||"The Global Rating of Change responses were summarised by treatment group and visit (Weeks 2, 4, 8 and 12) as categorical endpoints (worse, about the same and better). Pairwise comparisons were performed using the Cochran Mantel Haenszel test stratified by region using modified ridit scores (row mean scores differ)."||||0.025
72330126|NCT02993822|144185487|SUPERIORITY|||||||0.003|||||||Cochran-Mantel-Haenszel|||"The Global Rating of Change responses were summarised by treatment group and visit (Weeks 2, 4, 8 and 12) as categorical endpoints (worse, about the same and better). Pairwise comparisons were performed using the Cochran Mantel Haenszel test stratified by region using modified ridit scores (row mean scores differ)."||||0.003
72330127|NCT02993822|144185487|SUPERIORITY|||||||0.152|||||||Cochran-Mantel-Haenszel|||"The Global Rating of Change responses were summarised by treatment group and visit (Weeks 2, 4, 8 and 12) as categorical endpoints (worse, about the same and better). Pairwise comparisons were performed using the Cochran Mantel Haenszel test stratified by region using modified ridit scores (row mean scores differ)."||||0.152
72330128|NCT02993822|144185487|SUPERIORITY|||||||0.004|||||||Cochran-Mantel-Haenszel|||"The Global Rating of Change responses were summarised by treatment group and visit (Weeks 2, 4, 8 and 12) as categorical endpoints (worse, about the same and better). Pairwise comparisons were performed using the Cochran Mantel Haenszel test stratified by region using modified ridit scores (row mean scores differ)."||||0.004
72421680|NCT04858802|144354613|SUPERIORITY||Mean Difference (Final Values)|0.0|STANDARD_DEVIATION|0.56||1|TWO_SIDED|95.0|-0.1|0.1||Paired; the threshold for statistical significance was p = 0.05.|t-test, 2 sided|||Day 45|Difference = PROPEL Contour Sinus Implant mean Lund-Mackay score for the frontal sinus at Day 45 minus balloon sinus dilation alone mean Lund-Mackay score for the frontal sinus at Day 45|0.1|-0.1|1.00
72421681|NCT04858802|144354613|SUPERIORITY||Mean Difference (Final Values)|0.05|STANDARD_DEVIATION|0.42||0.288|TWO_SIDED|95.0|0.0|0.1||Paired; the threshold for statistical significance was p = 0.05.|t-test, 2 sided||Difference = PROPEL Contour Sinus Implant mean Lund-Mackay score for the frontal sinus at Day 180 minus balloon sinus dilation alone mean Lund-Mackay score for the frontal sinus at Day 180|Day 180||0.1|0.0|0.288
72421682|NCT04858802|144354614|SUPERIORITY||Mean Difference (Final Values)|-0.09|STANDARD_DEVIATION|0.64||0.225|TWO_SIDED|95.0|-0.2|0.1||Paired; the threshold for statistical significance was p = 0.05.|t-test, 2 sided||Difference = PROPEL Contour Sinus Implant mean Lund-Mackay score for the frontal sinus at Day 45 minus balloon sinus dilation alone mean Lund-Mackay score for the frontal sinus at Day 45|Day 45||0.1|-0.2|0.225
72330129|NCT02993822|144185488|SUPERIORITY|||||||0.1|||||||Cochran-Mantel-Haenszel|||"The Global Rating of Change responses were summarised by treatment group and visit (Weeks 2, 4, 8 and 12) as categorical endpoints (worse, about the same and better). Pairwise comparisons were performed using the Cochran Mantel Haenszel test stratified by region using modified ridit scores (row mean scores differ)."||||0.100
72330130|NCT02993822|144185488|SUPERIORITY|||||||0.557|||||||Cochran-Mantel-Haenszel|||"The Global Rating of Change responses were summarised by treatment group and visit (Weeks 2, 4, 8 and 12) as categorical endpoints (worse, about the same and better). Pairwise comparisons were performed using the Cochran Mantel Haenszel test stratified by region using modified ridit scores (row mean scores differ)."||||0.557
72330131|NCT02993822|144185488|SUPERIORITY|||||||0.054|||||||Cochran-Mantel-Haenszel|||"The Global Rating of Change responses were summarised by treatment group and visit (Weeks 2, 4, 8 and 12) as categorical endpoints (worse, about the same and better). Pairwise comparisons were performed using the Cochran Mantel Haenszel test stratified by region using modified ridit scores (row mean scores differ)."||||0.054
72421683|NCT04858802|144354614|SUPERIORITY||Mean Difference (Final Values)|-0.06|STANDARD_DEVIATION|0.65||0.388|TWO_SIDED|95.0|-0.2|0.1||Paired; the threshold for statistical significance was p = 0.05.|t-test, 2 sided||Difference = PROPEL Contour Sinus Implant mean Lund-Mackay score for the frontal sinus at Day 180 minus balloon sinus dilation alone modified Lund-Mackay score for the frontal sinus at Day 180|Day 180||0.1|-0.2|0.388
72421684|NCT04858802|144354615|SUPERIORITY||Mean Difference (Final Values)|-0.06|STANDARD_DEVIATION|0.68||0.537|TWO_SIDED|95.0|-0.2|0.1||Paired; the threshold for statistical significance was p = 0.05.|t-test, 2 sided||Difference = PROPEL Contour Sinus Implant mean adhesion/scarring grade in the frontal recess/FSO minus balloon sinus dilation alone mean adhesion/scarring grade in the frontal recess/FSO|Day 21||0.1|-0.2|0.537
72421685|NCT04858802|144354615|SUPERIORITY||Mean Difference (Final Values)|-0.18|STANDARD_DEVIATION|0.54||0.01|TWO_SIDED|95.0|-0.3|0.0||Paired; the threshold for statistical significance was p = 0.05.|t-test, 2 sided||Difference = PROPEL Contour Sinus Implant mean adhesion/scarring grade in the frontal recess/FSO minus balloon sinus dilation alone mean adhesion/scarring grade in the frontal recess/FSO|Day 45||0.0|-0.3|0.010
72421686|NCT04858802|144354615|SUPERIORITY||Mean Difference (Final Values)|-0.26|STANDARD_DEVIATION|0.7||0.003|TWO_SIDED|95.0|-0.4|-0.1||Paired; the threshold for statistical significance was p = 0.05.|t-test, 2 sided||Difference = PROPEL Contour Sinus Implant mean adhesion/scarring grade in the frontal recess/FSO minus balloon sinus dilation alone mean adhesion/scarring grade in the frontal recess/FSO|Day 90||-0.1|-0.4|0.003
72330132|NCT05285644|144185503|OTHER|Difference (2-sided)|Difference in Percentages|34.4|||<|0.0001|TWO_SIDED|95.0|26.9|42.0||Multiple imputation methodology was implemented in handling missing data, both related to and unrelated to intercurrent events.|Pearson's Chi-squared test||Difference equals 0.003% AR-15512 minus AR-15512 Vehicle|The primary estimand targeted the treatment effect attributable to the randomly assigned treatment, regardless of compliance to study treatment and assuming subjects who discontinued due to lack of efficacy, AEs, or disallowed concurrent treatments followed the behavior of subjects in the reference arm for the duration of the study and subjects who discontinued for other reasons would have followed the behavior of subjects who were still in the study under same randomly assigned treatment.|For binary endpoint, the underlying continuous measurement of unanesthetized Schirmer score was imputed, change score calculated and then dichotomized to ascertain attainment of greater than or equal to 10 millimeter increase from pre-drop baseline.|42.0|26.9|<0.0001
72330133|NCT05285644|144185504|OTHER|Difference (2-sided)|Least Squares Mean Difference|-5.1|STANDARD_ERROR_OF_MEAN|2.06||0.0138|TWO_SIDED|95.0|-9.1|-1.0||Multiple imputation methodology was implemented in handling missing data, both related to and unrelated to intercurrent events.|ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center.|Difference equals 0.003% AR-15512 minus AR-15512 Vehicle|The primary estimand targeted the treatment effect attributable to the randomly assigned treatment, regardless of compliance to study treatment and assuming subjects who discontinued due to lack of efficacy, AEs, or disallowed concurrent treatments followed the behavior of subjects in the reference arm for the duration of the study and subjects who discontinued for other reasons would have followed the behavior of subjects who were still in the study under same randomly assigned treatment.||-1.0|-9.1|0.0138
72330134|NCT05285644|144185505|OTHER|Difference (2-sided)|Least Squares Mean Difference|7.2|STANDARD_ERROR_OF_MEAN|0.7|<|0.0001|TWO_SIDED|95.0|5.8|8.6||Multiple imputation methodology was implemented in handling missing data, both related to and unrelated to intercurrent events.|ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||The primary estimand targeted the treatment effect attributable to the randomly assigned treatment, regardless of compliance to study treatment and assuming subjects who discontinued due to lack of efficacy, AEs, or disallowed concurrent treatments followed the behavior of subjects in the reference arm for the duration of the study and subjects who discontinued for other reasons would have followed the behavior of subjects who were still in the study under same randomly assigned treatment.|Difference equals 0.003% AR-15512 minus AR-15512 Vehicle|8.6|5.8|<0.0001
72368821|NCT01469377|144247340|SUPERIORITY||Least squares mean difference|-0.9||||0.2404|TWO_SIDED|95.0|-2.4|0.6||p-values were from an mixed-effects model for repeated measures with treatment group, pooled study center, visit, and treatment-group-by-visit interaction as fixed effects and the baseline value and baseline value-by-visit interaction as covariates.|Mixed-effect model for repeated measures|p-values were adjusted for multiple comparisons using the matched parallel gate-keeping procedure.||||0.6|-2.4|0.2404
72368822|NCT01469377|144247340|SUPERIORITY||Least squares mean difference|-2.2||||0.0114|TWO_SIDED|95.0|-3.7|-0.6||p-values were from an mixed-effects model for repeated measures with treatment group, pooled study center, visit, and treatment-group-by-visit interaction as fixed effects and the baseline value and baseline value-by-visit interaction as covariates.|Mixed-effect model for repeated measures|p-values were adjusted for multiple comparisons using the matched parallel gate-keeping procedure.||||-0.6|-3.7|0.0114
72330135|NCT05285644|144185506|OTHER|Difference (2-sided)|Difference in Percentages|26.7|||<|0.0001|TWO_SIDED|95.0|19.5|34.0||Multiple imputation methodology was implemented in handling missing data, both related to and unrelated to intercurrent events.|Pearson's Chi-squared test||Difference equals 0.003% AR-15512 minus AR-15512 Vehicle|The primary estimand targeted the treatment effect attributable to the randomly assigned treatment, regardless of compliance to study treatment and assuming subjects who discontinued due to lack of efficacy, AEs, or disallowed concurrent treatments followed the behavior of subjects in the reference arm for the duration of the study and subjects who discontinued for other reasons would have followed the behavior of subjects who were still in the study under same randomly assigned treatment.|For binary endpoint, the underlying continuous measurement of unanesthetized Schirmer score was imputed, change score calculated and then dichotomized to ascertain attainment of greater than or equal to 10 millimeter increase from pre-drop baseline.|34.0|19.5|<0.0001
72330136|NCT05285644|144185507|OTHER|Difference (2-sided)|Least Squares Mean Difference|6.2|STANDARD_ERROR_OF_MEAN|0.68|<|0.0001|TWO_SIDED|95.0|4.9|7.5||Multiple imputation methodology was implemented in handling missing data, both related to and unrelated to intercurrent events.|ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center|Difference equals 0.003% AR-15512 minus AR-15512 Vehicle|The primary estimand targeted the treatment effect attributable to the randomly assigned treatment, regardless of compliance to study treatment and assuming subjects who discontinued due to lack of efficacy, AEs, or disallowed concurrent treatments followed the behavior of subjects in the reference arm for the duration of the study and subjects who discontinued for other reasons would have followed the behavior of subjects who were still in the study under same randomly assigned treatment.||7.5|4.9|<0.0001
72330137|NCT05285644|144185508|OTHER|Difference (2 sided)|Difference in Percentages|33.1|||<|0.0001|TWO_SIDED|95.0|24.8|41.4||Multiple imputation methodology was implemented in handling missing data, both related to and unrelated to intercurrent events.|Pearson's Chi-squared test||Difference equals 0.003% AR-15512 minus AR-15512 Vehicle|The primary estimand targeted the treatment effect attributable to the randomly assigned treatment, regardless of compliance to study treatment and assuming subjects who discontinued due to lack of efficacy, AEs, or disallowed concurrent treatments followed the behavior of subjects in the reference arm for the duration of the study and subjects who discontinued for other reasons would have followed the behavior of subjects who were still in the study under same randomly assigned treatment.|For binary endpoint, the underlying continuous measurement of unanesthetized Schirmer score was imputed, change score calculated and then dichotomized to ascertain attainment of greater than or equal to 10 millimeter increase from pre-drop baseline.|41.4|24.8|<0.0001
72330138|NCT05285644|144185509|OTHER|Difference (2-sided)|Least Squares Mean Difference|7.5|STANDARD_ERROR_OF_MEAN|0.76|<|0.0001|TWO_SIDED|95.0|6.0|9.0||Multiple imputation methodology was implemented in handling missing data, both related to and unrelated to intercurrent events.|ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center|Difference equals 0.003% AR-15512 minus AR-15512 Vehicle|The primary estimand targeted the treatment effect attributable to the randomly assigned treatment, regardless of compliance to study treatment and assuming subjects who discontinued due to lack of efficacy, AEs, or disallowed concurrent treatments followed the behavior of subjects in the reference arm for the duration of the study and subjects who discontinued for other reasons would have followed the behavior of subjects who were still in the study under same randomly assigned treatment.||9.0|6.0|<0.0001
72330139|NCT05285644|144185510|OTHER|Difference (2-sided)|Least Squares Mean Difference|-2.8|STANDARD_ERROR_OF_MEAN|2.28||0.2184|TWO_SIDED|95.0|-7.3|1.7||Multiple imputation methodology was implemented in handling missing data, both related to and unrelated to intercurrent events.|ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center|Difference equals 0.003% AR-15512 minus AR-15512 Vehicle|The primary estimand targeted the treatment effect attributable to the randomly assigned treatment, regardless of compliance to study treatment and assuming subjects who discontinued due to lack of efficacy, AEs, or disallowed concurrent treatments followed the behavior of subjects in the reference arm for the duration of the study and subjects who discontinued for other reasons would have followed the behavior of subjects who were still in the study under same randomly assigned treatment.||1.7|-7.3|0.2184
72368823|NCT01469377|144247341|SUPERIORITY||Least squares mean difference|-1.1||||0.2404|TWO_SIDED|95.0|-2.5|0.3||p-values were from an mixed-effects model for repeated measures with treatment group, pooled study center, visit, and treatment-group-by-visit interaction as fixed effects and the baseline value and baseline value-by-visit interaction as covariates.|Mixed-effect model for repeated measures|p-values were adjusted for multiple comparisons using the matched parallel gate-keeping procedure.||||0.3|-2.5|0.2404
72368824|NCT01469377|144247341|SUPERIORITY||Least squares mean difference|-1.4||||0.114|TWO_SIDED|95.0|-2.8|0.0||p-values were from an mixed-effects model for repeated measures with treatment group, pooled study center, visit, and treatment-group-by-visit interaction as fixed effects and the baseline value and baseline value-by-visit interaction as covariates.|Mixed-effect model for repeated measures|p-values were adjusted for multiple comparisons using the matched parallel gate-keeping procedure.||||0.0|-2.8|0.1140
72330140|NCT05285644|144185511|OTHER|Difference (2-sided)|Least Squares Mean Difference|-2.7|STANDARD_ERROR_OF_MEAN|2.43||0.266|TWO_SIDED|94.0|-7.5|2.1||Multiple imputation methodology was implemented in handling missing data, both related to and unrelated to intercurrent events.|ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center|Difference equals 0.003% AR-15512 minus AR-15512 Vehicle|The primary estimand targeted the treatment effect attributable to the randomly assigned treatment, regardless of compliance to study treatment and assuming subjects who discontinued due to lack of efficacy, AEs, or disallowed concurrent treatments followed the behavior of subjects in the reference arm for the duration of the study and subjects who discontinued for other reasons would have followed the behavior of subjects who were still in the study under same randomly assigned treatment.||2.1|-7.5|0.2660
72330141|NCT05285644|144185512|OTHER|Difference (2-sided)|Least Squares Mean Difference|-2.6|STANDARD_ERROR_OF_MEAN|2.37||0.2741|TWO_SIDED|95.0|-7.2|2.0||Multiple imputation methodology was implemented in handling missing data, both related to and unrelated to intercurrent events.|ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center|Difference equals 0.003% AR-15512 minus AR-15512 Vehicle|The primary estimand targeted the treatment effect attributable to the randomly assigned treatment, regardless of compliance to study treatment and assuming subjects who discontinued due to lack of efficacy, AEs, or disallowed concurrent treatments followed the behavior of subjects in the reference arm for the duration of the study and subjects who discontinued for other reasons would have followed the behavior of subjects who were still in the study under same randomly assigned treatment.||2.0|-7.2|0.2741
72330142|NCT05285644|144185513|OTHER|Difference (2-sided)|Least Squares Mean Difference|-3.4|STANDARD_ERROR_OF_MEAN|2.43||0.159|TWO_SIDED|95.0|-8.2|1.3||Multiple imputation methodology was implemented in handling missing data, both related to and unrelated to intercurrent events.|ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center|Difference equals 0.003% AR-15512 minus AR-15512 Vehicle|The primary estimand targeted the treatment effect attributable to the randomly assigned treatment, regardless of compliance to study treatment and assuming subjects who discontinued due to lack of efficacy, AEs, or disallowed concurrent treatments followed the behavior of subjects in the reference arm for the duration of the study and subjects who discontinued for other reasons would have followed the behavior of subjects who were still in the study under same randomly assigned treatment.||1.3|-8.2|0.1590
72368825|NCT01322945|144247388|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||t-test, 2 sided|||||||0.001
72368826|NCT02605122|144247416|OTHER||Proportion experiencing TEAE or TESAE|34.3|||||TWO_SIDED|95.0|23.0|47.0||No p-value was performed. Study prematurely discontinued. Clopper-Pearson analysis was used to determine confidence intervals.|Clopper-Pearson|||||47|23|
72421687|NCT04858802|144354615|SUPERIORITY||Mean Difference (Final Values)|-0.21|STANDARD_DEVIATION|0.66||0.007|TWO_SIDED|95.0|-0.4|-0.1||Paired; the threshold for statistical significance was p = 0.05.|t-test, 2 sided||Difference = PROPEL Contour Sinus Implant mean adhesion/scarring grade in the frontal recess/FSO minus balloon sinus dilation alone mean adhesion/scarring grade in the frontal recess/FSO|Day 180||-0.1|-0.4|0.007
72368827|NCT02605122|144247417|OTHER||Achievement of ECR|62.1|||||TWO_SIDED|95.0|49.0|74.0||No p-value was performed. Study prematurely discontinued. Clopper-Pearson analysis was used to determine confidence intervals.|Clopper-Pearson|||||74|49|
72368828|NCT02605122|144247418|OTHER||Achievement of Clinical Improvement|68.7|||||TWO_SIDED|95.0|58.0|78.0||No p-value was performed. Study prematurely discontinued. Clopper-Pearson analysis was used to determine confidence intervals.|Clopper-Pearson|||||78|58|
72421688|NCT04858802|144354616|SUPERIORITY||Mean Difference (Final Values)|-2.46|STANDARD_DEVIATION|35.55||0.634|TWO_SIDED|95.0|-12.8|7.9||Paired; the threshold for statistical significance was p = 0.05.|t-test, 2 sided||Difference = PROPEL Contour Sinus Implant mean inflammation score in the frontal recess/FSO minus balloon sinus dilation alone mean inflammation score in the frontal recess/FSO|Day 21||7.9|-12.8|0.634
72330143|NCT05285644|144185514|OTHER|Difference (2-sided)|Least Squares Mean Difference|-4.0|STANDARD_ERROR_OF_MEAN|2.67||0.1369|TWO_SIDED|95.0|-9.2|1.3||Multiple imputation methodology was implemented in handling missing data, both related to and unrelated to intercurrent events.|ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center|Difference equals 0.003% AR-15512 minus AR-15512 Vehicle|The primary estimand targeted the treatment effect attributable to the randomly assigned treatment, regardless of compliance to study treatment and assuming subjects who discontinued due to lack of efficacy, AEs, or disallowed concurrent treatments followed the behavior of subjects in the reference arm for the duration of the study and subjects who discontinued for other reasons would have followed the behavior of subjects who were still in the study under same randomly assigned treatment.||1.3|-9.2|0.1369
72330144|NCT03335150|144185555|OTHER|Equality|Mean Difference (Final Values)|0.4856||||0.6662|TWO_SIDED|||||Interaction term|Mixed Models Analysis||Estimated Value = Standard Error (SE) of the interaction term.|||||0.6662
72330145|NCT03335150|144185555|OTHER|Equality|Mean Difference (Final Values)|0.2415||||0.1617|TWO_SIDED||||||Mixed Models Analysis|Mean Matrix Reasoning Total (MRT) difference between two visits while controlling for intervention.|estimated value = SE|||||0.1617
72330146|NCT03335150|144185555|OTHER|Equality|Mean Difference (Final Values)|0.5087||||0.6236|TWO_SIDED||||||Mixed Models Analysis|Mean MRT difference between two interventions while controlling for visit.|estimated value = SE|||||0.6236
72330147|NCT03335150|144185556|OTHER|Equality|Mean Difference (Final Values)|0.58||||0.0496|TWO_SIDED|||||Interaction term|Mixed Models Analysis||Estimated value = SE of interaction term|||||0.0496
72330148|NCT03335150|144185557|OTHER|Equality|Mean Difference (Final Values)|1.62||||0.047|TWO_SIDED|||||Interaction term|Mixed Models Analysis||Estimated Value = SE of interaction term|||||0.047
72330149|NCT03335150|144185558|OTHER|Equality|Mean Difference (Final Values)|2.97||||0.001|TWO_SIDED|||||Interaction Term|Mixed Models Analysis||Estimated Value = SE of interaction term|||||0.001
72330150|NCT03335150|144185559|OTHER|Equality|Mean Difference (Final Values)|2.25||||0.02|TWO_SIDED|||||Interaction term|Mixed Models Analysis||Estimated Value = SE of interaction term|||||0.020
72330151|NCT03335150|144185560|OTHER|Equality|Mean Difference (Final Values)|1.26||||0.444|TWO_SIDED|||||Interaction term|Mixed Models Analysis||Estimated Value = SE of interaction term|||||0.444
72330152|NCT03335150|144185560|OTHER|Equality|Mean Difference (Final Values)|1.145||||0.0233|TWO_SIDED||||||Mixed Models Analysis|There is significant difference in MIST between intervention groups controlling for visit and other significant covariates.|estimated value = SE|||||0.0233
72330153|NCT03335150|144185560|OTHER|Equality|Mean Difference (Final Values)|0.6281|||<|0|TWO_SIDED||||||Mixed Models Analysis|There is significant difference in MIST between baseline and week 10 controlling for intervention group and other significant covariates|estimated value = SE|||||<0.000
72330154|NCT03335150|144185561|OTHER|Equality|Mean Difference (Final Values)|2.205||||0.073|TWO_SIDED|||||Interaction term|Mixed Models Analysis||estimated value = SE of interaction term|||||0.073
72330155|NCT03335150|144185562|OTHER|Equality|Mean Difference (Final Values)|2.25||||0.82|TWO_SIDED|||||Interaction Term|Mixed Models Analysis|||||||0.82
72330156|NCT03335150|144185562|OTHER|Equality|Mean Difference (Final Values)|1.1172||||0.0257|TWO_SIDED||||||Mixed Models Analysis|Mean PDQ-39 difference between baseline and week 10 controlling for intervention and covariates.|estimated value = SE|||||0.0257
72330157|NCT03335150|144185562|OTHER|Equality|Mean Difference (Final Values)|3.8649||||0.1101|TWO_SIDED||||||Mixed Models Analysis|Difference in PDQ-39 between two interventions controlling for visit and covariates.|estimated value = SE|||||0.1101
72330158|NCT03335150|144185563|OTHER|Equality|Median Difference (Final Values)|1.784||||0.0263|TWO_SIDED|||||Interaction term|Mixed Models Analysis||Estimated Value = SE of the interaction term.|||||0.0263
72330159|NCT02712983|144185582|OTHER||LS Mean Diff (SE) vs pooled placebo|-2.4|STANDARD_ERROR_OF_MEAN|0.6|||TWO_SIDED|95.0|-3.62|-1.22||||||Day 8 Cohort A: TIP, Pooled PBO||-1.22|-3.62|
72330160|NCT02712983|144185582|OTHER||LS Mean Diff (SE) vs pooled placebo|-2.1|STANDARD_ERROR_OF_MEAN|0.58|||TWO_SIDED|95.0|-3.3|-0.98||||||Day 8 Cohort A: TIP/PBO, Pooled PBO||-0.98|-3.30|
72330161|NCT02712983|144185582|OTHER||LS Mean Diff (SE) vs pooled placebo|-1.9|STANDARD_ERROR_OF_MEAN|0.63|||TWO_SIDED|95.0|-3.2|-0.68||||||Day 8 Cohort B: TIP, Pooled PBO||-0.68|-3.20|
72330162|NCT02712983|144185582|OTHER||LS Mean Diff (SE) vs pooled placebo|-3.3|STANDARD_ERROR_OF_MEAN|0.56|||TWO_SIDED|95.0|-4.38|-2.15||||||Day 8 Cohort B: TIP/PBO, Pooled PBO|LS Mean Diff (SE) vs pooled placebo|-2.15|-4.38|
72330163|NCT02712983|144185582|OTHER||LS Mean Diff (SE) vs pooled placebo|-4.0|STANDARD_ERROR_OF_MEAN|0.55|||TWO_SIDED|95.0|-5.06|-2.88||||||Day 8 Cohort C: TIP, Pooled PBO||-2.88|-5.06|
72330164|NCT02712983|144185582|OTHER||LS Mean Diff (SE) vs pooled placebo|-3.4|STANDARD_ERROR_OF_MEAN|0.61|||TWO_SIDED|95.0|-4.57|-2.14||||||Day 8 Cohort C: TIP/PBO, Pooled PBO||-2.14|-4.57|
72330165|NCT02712983|144185582|OTHER||LS Mean Diff (SE) vs pooled placebo|-2.8|STANDARD_ERROR_OF_MEAN|0.44|||TWO_SIDED|95.0|-3.66|-1.89||||||Day 8: Pooled TIP, Pooled PBO||-1.89|-3.66|
72330166|NCT02712983|144185582|OTHER||LS Mean Diff (SE) vs pooled placebo|-2.9|STANDARD_ERROR_OF_MEAN|0.43|||TWO_SIDED|95.0|-3.79|-2.05||||||Day 8: Pooled TIP/PBO, Pooled PBO||-2.05|-3.79|
72330167|NCT02712983|144185582|OTHER||LS Mean Diff (SE) vs pooled placebo|-2.8|STANDARD_ERROR_OF_MEAN|0.75|||TWO_SIDED|95.0|-4.28|-1.31||||||Day 29 Cohort A: TIP, Pooled PBO||-1.31|-4.28|
72330168|NCT02712983|144185582|OTHER||LS Mean Diff (SE) vs pooled placebo|-2.4|STANDARD_ERROR_OF_MEAN|0.84|||TWO_SIDED|95.0|-4.03|-0.67||||||Day 29 Cohort A: TIP/PBO, Pooled PBO||-0.67|-4.03|
72330169|NCT02712983|144185582|OTHER||LS Mean Diff (SE) vs pooled placebo|-2.3|STANDARD_ERROR_OF_MEAN|0.88|||TWO_SIDED|95.0|-4.04|-0.52||||||Day 29 Cohort B: TIP, Pooled PBO||-0.52|-4.04|
72330170|NCT02712983|144185582|OTHER||LS Mean Diff (SE) vs pooled placebo|-3.5|STANDARD_ERROR_OF_MEAN|0.83|||TWO_SIDED|95.0|-5.16|-1.85||||||Day 29 Cohort B: TIP/PBO, Pooled PBO||-1.85|-5.16|
72330171|NCT02712983|144185582|OTHER||LS Mean Diff (SE) vs pooled placebo|-4.6|STANDARD_ERROR_OF_MEAN|0.76|||TWO_SIDED|95.0|-6.13|-3.09||||||Day 29 Cohort C: TIP, Pooled PBO||-3.09|-6.13|
72330172|NCT02712983|144185582|OTHER||LS Mean Diff (SE) vs pooled placebo|-3.1|STANDARD_ERROR_OF_MEAN|0.79|||TWO_SIDED|95.0|-4.68|-1.52||||||Day 29 Cohort C: TIP/PBO, Pooled PBO||-1.52|-4.68|
72330173|NCT02712983|144185582|OTHER||LS Mean Diff (SE) vs pooled placebo|-3.2|STANDARD_ERROR_OF_MEAN|0.61|||TWO_SIDED|95.0|-4.43|-2.02||||||Day 29: Pooled TIP, Pooled PBO||-2.02|-4.43|
72330174|NCT02712983|144185582|OTHER||LS Mean Diff (SE) vs pooled placebo|-3.0|STANDARD_ERROR_OF_MEAN|0.61|||TWO_SIDED|95.0|-4.19|-1.78||||||Day 29: Pooled TIP/PBO, Pooled PBO||-1.78|-4.19|
72330175|NCT02712983|144185583|OTHER||LS Mean Diff (SE) vs pooled placebo|-2.1|STANDARD_ERROR_OF_MEAN|0.87|||TWO_SIDED|95.0|-3.82|-0.36||||||Day 57 Cohort A: TIP, Pooled PBO||-0.36|-3.82|
72421689|NCT04858802|144354616|SUPERIORITY||Mean Difference (Final Values)|-7.63|STANDARD_DEVIATION|29.04||0.048|TWO_SIDED|95.0|-15.2|-0.1||Paired; the threshold for statistical significance was p = 0.05.|t-test, 2 sided||Difference = PROPEL Contour Sinus Implant mean inflammation score in the frontal recess/FSO minus balloon sinus dilation alone mean inflammation score in the frontal recess/FSO|Day 45||-0.1|-15.2|0.048
72421690|NCT04858802|144354616|SUPERIORITY||Mean Difference (Final Values)|-7.78|STANDARD_DEVIATION|28.79||0.028|TWO_SIDED|95.0|-14.7|-0.9||Paired; the threshold for statistical significance was p = 0.05.|t-test, 2 sided||Difference = PROPEL Contour Sinus Implant mean inflammation score in the frontal recess/FSO minus balloon sinus dilation alone mean inflammation score in the frontal recess/FSO|Day 90||-0.9|-14.7|0.028
72421691|NCT04858802|144354616|SUPERIORITY||Mean Difference (Final Values)|-6.76|STANDARD_DEVIATION|27.99||0.041|TWO_SIDED|95.0|-13.2|-0.3||Paired; the threshold for statistical significance was p = 0.05.|t-test, 2 sided||Difference = PROPEL Contour Sinus Implant mean inflammation score in the frontal recess/FSO minus balloon sinus dilation alone mean inflammation score in the frontal recess/FSO|Day 180||-0.3|-13.2|0.041
72421692|NCT04858802|144354617|SUPERIORITY||Mean Difference (Final Values)|-0.26|STANDARD_DEVIATION|0.96||0.063|TWO_SIDED|95.0|-0.5|0.0||Paired; the threshold for statistical significance was p = 0.05.|t-test, 2 sided||Difference = PROPEL Contour Sinus Implant mean polypoid edema grade in the frontal recess/FSO minus balloon sinus dilation alone mean polypoid edema grade in the frontal recess/FSO|Day 21||0.0|-0.5|0.063
72421693|NCT04858802|144354617|SUPERIORITY||Mean Difference (Final Values)|-0.25|STANDARD_DEVIATION|0.77||0.015|TWO_SIDED|95.0|-0.4|-0.1||Paired; the threshold for statistical significance was p = 0.05.|t-test, 2 sided||Difference = PROPEL Contour Sinus Implant mean polypoid edema grade in the frontal recess/FSO minus balloon sinus dilation alone mean polypoid edema grade in the frontal recess/FSO|Day 45||-0.1|-0.4|0.015
72421694|NCT04858802|144354617|SUPERIORITY||Mean Difference (Final Values)|-0.26|STANDARD_DEVIATION|0.78||0.007|TWO_SIDED|95.0|-0.4|-0.1||Paired; the threshold for statistical significance was p = 0.05.|t-test, 2 sided||Difference = PROPEL Contour Sinus Implant mean polypoid edema grade in the frontal recess/FSO minus balloon sinus dilation alone mean polypoid edema grade in the frontal recess/FSO|Day 90||-0.1|-0.4|0.007
72421695|NCT04858802|144354617|SUPERIORITY||Mean Difference (Final Values)|-0.19|STANDARD_DEVIATION|0.75||0.034|TWO_SIDED|95.0|-0.4|0.0||Paired; the threshold for statistical significance was p = 0.05.|t-test, 2 sided||Difference = PROPEL Contour Sinus Implant mean polypoid edema grade in the frontal recess/FSO minus balloon sinus dilation alone mean polypoid edema grade in the frontal recess/FSO|Day 180||0.0|-0.4|0.034
72421696|NCT04858802|144354618|SUPERIORITY||Mean Difference (Final Values)|-0.2|STANDARD_DEVIATION|0.65||0.83|TWO_SIDED|95.0|-0.2|0.2||Paired; the threshold for statistical significance was p = 0.05.|t-test, 2 sided||Difference = PROPEL Contour Sinus Implant mean adhesion/scarring grade in the ethmoid sinus minus balloon sinus dilation alone mean adhesion/scarring grade in the ethmoid sinus|Day 21||0.2|-0.2|0.830
72421697|NCT04858802|144354618|SUPERIORITY||Mean Difference (Final Values)|-0.02|STANDARD_DEVIATION|0.59||0.829|TWO_SIDED|95.0|-0.2|0.1||Paired; the threshold for statistical significance was p = 0.05.|t-test, 2 sided||Difference = PROPEL Contour Sinus Implant mean adhesion/scarring grade in the ethmoid sinus minus balloon sinus dilation alone mean adhesion/scarring grade in the ethmoid sinus|Day 45||0.1|-0.2|0.829
72421698|NCT04858802|144354618|SUPERIORITY||Mean Difference (Final Values)|-0.12|STANDARD_DEVIATION|0.64||0.132|TWO_SIDED|95.0|-0.3|0.0||Paired; the threshold for statistical significance was p = 0.05.|t-test, 2 sided||Difference = PROPEL Contour Sinus Implant mean adhesion/scarring grade in the ethmoid sinus minus balloon sinus dilation alone mean adhesion/scarring grade in the ethmoid sinus|Day 90||0.0|-0.3|0.132
72330176|NCT02712983|144185583|OTHER||LS Mean Diff (SE) vs pooled placebo|-0.5|STANDARD_ERROR_OF_MEAN|0.88|||TWO_SIDED|95.0|-2.21|1.29||||||Day 57 Cohort A: TIP/PBO, Pooled PBO||1.29|-2.21|
72330177|NCT02712983|144185583|OTHER||LS Mean Diff (SE) vs pooled placebo|-1.9|STANDARD_ERROR_OF_MEAN|0.99|||TWO_SIDED|95.0|-3.87|0.08||||||Day 57 Cohort B: TIP, Pooled PBO||0.08|-3.87|
72330178|NCT02712983|144185583|OTHER||LS Mean Diff (SE) vs pooled placebo|-1.6|STANDARD_ERROR_OF_MEAN|0.88|||TWO_SIDED|95.0|-3.34|0.16||||||Day 57 Cohort B: TIP/PBO, Pooled PBO||0.16|-3.34|
72330179|NCT02712983|144185583|OTHER||LS Mean Diff (SE) vs pooled placebo|-3.9|STANDARD_ERROR_OF_MEAN|0.82|||TWO_SIDED|95.0|-5.5|-2.22||||||Day 57 Cohort C: TIP, Pooled PBO||-2.22|-5.50|
72330180|NCT02712983|144185583|OTHER||LS Mean Diff (SE) vs pooled placebo|-1.4|STANDARD_ERROR_OF_MEAN|0.92|||TWO_SIDED|95.0|-3.26|0.41||||||Day 57 Cohort C: TIP/PBO, Pooled PBO||0.41|-3.26|
72330181|NCT02712983|144185583|OTHER||LS Mean Diff (SE) vs pooled placebo|-2.6|STANDARD_ERROR_OF_MEAN|0.68|||TWO_SIDED|95.0|-3.98|-1.25||||||Day 57: Pooled TIP, Pooled PBO||-1.25|-3.98|
72330182|NCT02712983|144185583|OTHER||LS Mean Diff (SE) vs pooled placebo|-1.2|STANDARD_ERROR_OF_MEAN|0.67|||TWO_SIDED|95.0|-2.5|0.19||||||Day 57: Pooled TIP/PBO, Pooled PBO||0.19|-2.50|
72330183|NCT02712983|144185583|OTHER||LS Mean Diff (SE) vs pooled placebo|-2.2|STANDARD_ERROR_OF_MEAN|0.9|||TWO_SIDED|95.0|-4.0|-0.38||||||Day 85 Cohort A: TIP, Pooled PBO||-0.38|-4.00|
72330184|NCT02712983|144185583|OTHER||LS Mean Diff (SE) vs pooled placebo|-1.8|STANDARD_ERROR_OF_MEAN|0.99|||TWO_SIDED|95.0|-3.81|0.13||||||Day 85 Cohort A: TIP/PBO, Pooled PBO||0.13|-3.81|
72330185|NCT02712983|144185583|OTHER||LS Mean Diff (SE) vs pooled placebo|-2.7|STANDARD_ERROR_OF_MEAN|1.11|||TWO_SIDED|95.0|-4.96|-0.53||||||Day 85 Cohort B: TIP, Pooled PBO||-0.53|-4.96|
72330186|NCT02712983|144185583|OTHER||LS Mean Diff (SE) vs pooled placebo|-3.6|STANDARD_ERROR_OF_MEAN|0.93|||TWO_SIDED|95.0|-5.44|-1.73||||||Day 85 Cohort B: TIP/PBO, Pooled PBO||-1.73|-5.44|
72330187|NCT02712983|144185583|OTHER||LS Mean Diff (SE) vs pooled placebo|-3.0|STANDARD_ERROR_OF_MEAN|0.96|||TWO_SIDED|95.0|-4.9|-1.07||||||Day 85 Cohort C: TIP, Pooled PBO||-1.07|-4.90|
72330188|NCT02712983|144185583|OTHER||LS Mean Diff (SE) vs pooled placebo|-2.6|STANDARD_ERROR_OF_MEAN|1.03|||TWO_SIDED|95.0|-4.66|-0.53||||||Day 85 Cohort C: TIP/PBO, Pooled PBO||-0.53|-4.66|
72330189|NCT02712983|144185583|OTHER||LS Mean Diff (SE) vs pooled placebo|-2.6|STANDARD_ERROR_OF_MEAN|0.74|||TWO_SIDED|95.0|-4.11|-1.17||||||Day 85: Pooled TIP, Pooled PBO||-1.17|-4.11|
72330190|NCT02712983|144185583|OTHER||LS Mean Diff (SE) vs pooled placebo|-2.7|STANDARD_ERROR_OF_MEAN|0.72|||TWO_SIDED|95.0|-4.12|-1.23||||||Day 85: Pooled TIP/PBO, Pooled PBO||-1.23|-4.12|
72330191|NCT02712983|144185583|OTHER||LS Mean Diff (SE) vs pooled placebo|-2.8|STANDARD_ERROR_OF_MEAN|0.87|||TWO_SIDED|95.0|-4.55|-1.08||||||Day 113 Cohort A: TIP, Pooled PBO||-1.08|-4.55|
72330192|NCT02712983|144185583|OTHER||LS Mean Diff (SE) vs pooled placebo|0.1|STANDARD_ERROR_OF_MEAN|0.83|||TWO_SIDED|95.0|-1.61|1.71||||||Day 113 Cohort A: TIP/PBO, Pooled PBO||1.71|-1.61|
72330193|NCT02712983|144185583|OTHER||LS Mean Diff (SE) vs pooled placebo|-2.6|STANDARD_ERROR_OF_MEAN|1.16|||TWO_SIDED|95.0|-4.93|-0.29||||||Day 113 Cohort B: TIP, Pooled PBO||-0.29|-4.93|
72421699|NCT04858802|144354618|SUPERIORITY||Mean Difference (Final Values)|-0.09|STANDARD_DEVIATION|0.79||0.31|TWO_SIDED|95.0|-0.3|0.1|||t-test, 2 sided||Difference = PROPEL Contour Sinus Implant mean adhesion/scarring grade in the ethmoid sinus minus balloon sinus dilation alone mean adhesion/scarring grade in the ethmoid sinus|Day 180||0.1|-0.3|0.310
72330194|NCT02712983|144185583|OTHER||LS Mean Diff (SE) vs pooled placebo|-1.9|STANDARD_ERROR_OF_MEAN|0.84|||TWO_SIDED|95.0|-3.62|-0.25||||||Day 113 Cohort B: TIP/PBO, Pooled PBO||-0.25|-3.62|
72330195|NCT02712983|144185583|OTHER||LS Mean Diff (SE) vs pooled placebo|-3.1|STANDARD_ERROR_OF_MEAN|0.91|||TWO_SIDED|95.0|-4.94|-1.3||||||Day 113 Cohort C: TIP, Pooled PBO||-1.30|-4.94|
72330196|NCT02712983|144185583|OTHER||LS Mean Diff (SE) vs pooled placebo|-2.4|STANDARD_ERROR_OF_MEAN|0.98|||TWO_SIDED|95.0|-4.37|-0.43||||||Day 113 Cohort C: TIP/PBO, Pooled PBO||-0.43|-4.37|
72330197|NCT02712983|144185583|OTHER||LS Mean Diff (SE) vs pooled placebo|-2.8|STANDARD_ERROR_OF_MEAN|0.7|||TWO_SIDED|95.0|-4.24|-1.45||||||Day 113: Pooled TIP, Pooled PBO||-1.45|-4.24|
72330198|NCT02712983|144185583|OTHER||LS Mean Diff (SE) vs pooled placebo|-1.4|STANDARD_ERROR_OF_MEAN|0.65|||TWO_SIDED|95.0|-2.73|-0.13||||||Day 113: Pooled TIP/PBO, Pooled PBO||-0.13|-2.73|
72330199|NCT02712983|144185583|OTHER||LS Mean Diff (SE) vs pooled placebo|-2.2|STANDARD_ERROR_OF_MEAN|0.73|||TWO_SIDED|95.0|-3.64|-0.73||||||EoT Cohort A: TIP, Pooled PBO||-0.73|-3.64|
72330200|NCT02712983|144185583|OTHER||LS Mean Diff (SE) vs pooled placebo|-0.1|STANDARD_ERROR_OF_MEAN|0.76|||TWO_SIDED|95.0|-1.61|1.43||||||EoT Cohort A: TIP/PBO, Pooled PBO||1.43|-1.61|
72330201|NCT02712983|144185583|OTHER||LS Mean Diff (SE) vs pooled placebo|-1.3|STANDARD_ERROR_OF_MEAN|0.77|||TWO_SIDED|95.0|-2.81|0.25||||||EoT Cohort B: TIP, Pooled PBO||0.25|-2.81|
72330202|NCT02712983|144185583|OTHER||LS Mean Diff (SE) vs pooled placebo|-1.7|STANDARD_ERROR_OF_MEAN|0.73|||TWO_SIDED|95.0|-3.14|-0.22||||||EoT Cohort B: TIP/PBO, Pooled PBO||-0.22|-3.14|
72330203|NCT02712983|144185583|OTHER||LS Mean Diff (SE) vs pooled placebo|-2.4|STANDARD_ERROR_OF_MEAN|0.73|||TWO_SIDED|95.0|-3.89|-0.98||||||EoT Cohort C: TIP, Pooled PBO||-0.98|-3.89|
72330204|NCT02712983|144185583|OTHER||LS Mean Diff (SE) vs pooled placebo|-1.7|STANDARD_ERROR_OF_MEAN|0.73|||TWO_SIDED|95.0|-3.12|-0.22||||||EoT Cohort C: TIP/PBO, Pooled PBO||-0.22|-3.12|
72330205|NCT02712983|144185583|OTHER||LS Mean Diff (SE) vs pooled placebo|-2.0|STANDARD_ERROR_OF_MEAN|0.56|||TWO_SIDED|95.0|-3.08|-0.85||||||EoT: Pooled TIP, Pooled PBO||-0.85|-3.08|
72330206|NCT02712983|144185583|OTHER||LS Mean Diff (SE) vs pooled placebo|-1.1|STANDARD_ERROR_OF_MEAN|0.56|||TWO_SIDED|95.0|-2.25|-0.04||||||EoT: Pooled TIP/PBO, Pooled PBO||-0.04|-2.25|
72330207|NCT02712983|144185583|OTHER||LS Mean Diff (SE) vs pooled placebo|-0.8|STANDARD_ERROR_OF_MEAN|0.91|||TWO_SIDED|95.0|-2.63|0.99||||||Day 141 Cohort A: TIP, Pooled PBO||0.99|-2.63|
72330208|NCT02712983|144185583|OTHER||LS Mean Diff (SE) vs pooled placebo|0.1|STANDARD_ERROR_OF_MEAN|0.95|||TWO_SIDED|95.0|-1.83|1.98||||||Day 141 Cohort A: TIP/PBO, Pooled PBO||1.98|-1.83|
72330209|NCT02712983|144185583|OTHER||LS Mean Diff (SE) vs pooled placebo|0.2|STANDARD_ERROR_OF_MEAN|1.11|||TWO_SIDED|95.0|-2.03|2.41||||||Day 141 Cohort B: TIP, Pooled PBO||2.41|-2.03|
72330210|NCT02712983|144185583|OTHER||LS Mean Diff (SE) vs pooled placebo|-1.8|STANDARD_ERROR_OF_MEAN|0.92|||TWO_SIDED|95.0|-3.68|-0.01||||||Day 141 Cohort B: TIP/PBO, Pooled PBO||-0.01|-3.68|
72330211|NCT02712983|144185583|OTHER||LS Mean Diff (SE) vs pooled placebo|-0.9|STANDARD_ERROR_OF_MEAN|0.96|||TWO_SIDED|95.0|-2.78|1.07||||||Day 141 Cohort C (4 capsules b.i.d.): TIP, Pooled PBO||1.07|-2.78|
72330212|NCT02712983|144185583|OTHER||LS Mean Diff (SE) vs pooled placebo|-1.2|STANDARD_ERROR_OF_MEAN|1.06|||TWO_SIDED|95.0|-3.36|0.89||||||Day 141 Cohort C: TIP/PBO, Pooled PBO||0.89|-3.36|
72330213|NCT02712983|144185583|OTHER||LS Mean Diff (SE) vs pooled placebo|-0.5|STANDARD_ERROR_OF_MEAN|0.74|||TWO_SIDED|95.0|-1.97|0.98||||||Day 141: Pooled TIP, Pooled PBO||0.98|-1.97|
72330214|NCT02712983|144185583|OTHER||LS Mean Diff (SE) vs pooled placebo|-1.0|STANDARD_ERROR_OF_MEAN|0.73|||TWO_SIDED|95.0|-2.45|0.45||||||Day 141: Pooled TIP/PBO, Pooled PBO||0.45|-2.45|
72330215|NCT02712983|144185583|OTHER||LS Mean Diff (SE) vs pooled placebo|-1.3|STANDARD_ERROR_OF_MEAN|0.96|||TWO_SIDED|95.0|-3.24|0.61||||||Day 169 Cohort A: TIP, Pooled PBO||0.61|-3.24|
72330216|NCT02712983|144185583|OTHER||LS Mean Diff (SE) vs pooled placebo|-1.1|STANDARD_ERROR_OF_MEAN|0.99|||TWO_SIDED|95.0|-3.05|0.91||||||Day 169 Cohort A: TIP/PBO, Pooled PBO||0.91|-3.05|
72330217|NCT02712983|144185583|OTHER||LS Mean Diff (SE) vs pooled placebo|-0.6|STANDARD_ERROR_OF_MEAN|1.09|||TWO_SIDED|95.0|-2.73|1.62||||||Day 169 Cohort B: TIP, Pooled PBO||1.62|-2.73|
72330218|NCT02712983|144185583|OTHER||LS Mean Diff (SE) vs pooled placebo|-2.1|STANDARD_ERROR_OF_MEAN|1.03|||TWO_SIDED|95.0|-4.22|-0.08||||||Day 169 Cohort B: TIP/PBO, Pooled PBO||-0.08|-4.22|
72330219|NCT02712983|144185583|OTHER||LS Mean Diff (SE) vs pooled placebo|-0.2|STANDARD_ERROR_OF_MEAN|1.14|||TWO_SIDED|95.0|-2.48|2.1||||||Day 169 Cohort C: TIP, Pooled PBO||2.10|-2.48|
72421700|NCT04858802|144354619|SUPERIORITY||Mean Difference (Final Values)|-0.03|STANDARD_DEVIATION|0.48||0.666|TWO_SIDED|95.0|-0.2|0.1||Paired; the threshold for statistical significance was p = 0.05.|t-test, 2 sided||Difference = PROPEL Contour Sinus Implant mean polyp grade in the ethmoid sinus minus balloon sinus dilation alone mean polyp grade in the ethmoid sinus|Day 21||0.1|-0.2|0.666
72421701|NCT04858802|144354619|SUPERIORITY||Mean Difference (Final Values)|-0.04|STANDARD_DEVIATION|0.46||0.497|TWO_SIDED|95.0|-0.2|0.1||Paired; the threshold for statistical significance was p = 0.05.|t-test, 2 sided||Difference = PROPEL Contour Sinus Implant mean polyp grade in the ethmoid sinus minus balloon sinus dilation alone mean polyp grade in the ethmoid sinus|Day 45||0.1|-0.2|0.497
72330220|NCT02712983|144185583|OTHER||LS Mean Diff (SE) vs pooled placebo|-0.1|STANDARD_ERROR_OF_MEAN|1.12|||TWO_SIDED|95.0|-2.33|2.13||||||Day 169 Cohort C: TIP/PBO, Pooled PBO||2.13|-2.33|
72330221|NCT02712983|144185583|OTHER||LS Mean Diff (SE) vs pooled placebo|-0.7|STANDARD_ERROR_OF_MEAN|0.77|||TWO_SIDED|95.0|-2.24|0.86||||||Day 169: Pooled TIP, Pooled PBO||0.86|-2.24|
72330222|NCT02712983|144185583|OTHER||LS Mean Diff (SE) vs pooled placebo|-1.1|STANDARD_ERROR_OF_MEAN|0.75|||TWO_SIDED|95.0|-2.61|0.4||||||Day 169: Pooled TIP/PBO, Pooled PBO||0.40|-2.61|
72330223|NCT02712983|144185584|OTHER||Hazard Ratio (HR)|1.14|||||TWO_SIDED|95.0|0.14|3.18|||||Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.|Overall Cohort A: TIP, Pooled PBO||3.18|0.14|
72330224|NCT02712983|144185584|OTHER||Hazard Ratio (HR)|0.57|||||TWO_SIDED|95.0|0.18|1.85|||||Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.|Overall Cohort A: TIP/PBO, Pooled PBO||1.85|0.18|
72330225|NCT02712983|144185584|OTHER||Hazard Ratio (HR)|1.26|||||TWO_SIDED|95.0|0.42|3.77|||||Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.|Overall Cohort B: TIP, Pooled PBO||3.77|0.42|
72330226|NCT02712983|144185584|OTHER||Hazard Ratio (HR)|0.61|||||TWO_SIDED|95.0|0.2|1.83|||||Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.|Overall Cohort B: TIP/PBO, Pooled PBO||1.83|0.20|
72330227|NCT02712983|144185584|OTHER||Hazard Ratio (HR)|0.67|||||TWO_SIDED|95.0|0.21|2.17|||||Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.|Overall Cohort C: TIP, Pooled PBO||2.17|0.21|
72330228|NCT02712983|144185584|OTHER||Hazard Ratio (HR)|1.27|||||TWO_SIDED|95.0|0.44|3.62|||||Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.|Overall Cohort C: TIP/PBO, Pooled PBO||3.62|0.44|
72330229|NCT02712983|144185584|OTHER||Hazard Ratio (HR)|0.99|||||TWO_SIDED|95.0|0.44|2.23|||||Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.|Overall Pooled TIP, Pooled PBO||2.23|0.44|
72330230|NCT02712983|144185584|OTHER||Hazard Ratio (HR)|0.76|||||TWO_SIDED|95.0|0.34|1.71|||||Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.|Overall Pooled TIP/PBO, Pooled PBO||1.71|0.34|
72330231|NCT02712983|144185584|OTHER||Hazard Ratio (HR)|0.39|||||TWO_SIDED|95.0|0.08|1.83|||||Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.|Oral Cohort A: TIP, Pooled PBO||1.83|0.08|
72330232|NCT02712983|144185584|OTHER||Hazard Ratio (HR)|0.85|||||TWO_SIDED|95.0|0.25|2.89|||||Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.|Oral Cohort A: TIP/PBO, Pooled PBO||2.89|0.25|
72330233|NCT02712983|144185584|OTHER||Hazard Ratio (HR)|0.98|||||TWO_SIDED|95.0|0.25|3.93|||||Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.|Oral Cohort B: TIP, Pooled PBO||3.93|0.25|
72330234|NCT02712983|144185584|OTHER||Hazard Ratio (HR)|0.67|||||TWO_SIDED|95.0|0.19|2.36|||||Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.|Oral Cohort B: TIP/PBO, Pooled PBO||2.36|0.19|
72330235|NCT02712983|144185584|OTHER||Hazard Ratio (HR)|0.19|||||TWO_SIDED|95.0|0.02|1.57|||||Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.|Oral Cohort C: TIP, Pooled PBO||1.57|0.02|
72330236|NCT02712983|144185584|OTHER||Hazard Ratio (HR)|0.62|||||TWO_SIDED|95.0|0.16|2.41|||||Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.|Oral Cohort C: TIP/PBO, Pooled PBO||2.41|0.16|
72330237|NCT02712983|144185584|OTHER||Hazard Ratio (HR)|0.42|||||TWO_SIDED|95.0|0.13|1.31|||||Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.|Oral Pooled TIP, Pooled PBO||1.31|0.13|
72330238|NCT02712983|144185584|OTHER||Hazard Ratio (HR)|0.71|||||TWO_SIDED|95.0|0.28|1.8|||||Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.|Oral Pooled TIP/PBO, Pooled PBO||1.80|0.28|
72330239|NCT02712983|144185584|OTHER||Hazard Ratio (HR)|10.71|||||TWO_SIDED|95.0|1.1|104.19|||||Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.|Parenteral Cohort A: TIP, Pooled PBO||104.19|1.10|
72330240|NCT02712983|144185584|OTHER||Hazard Ratio (HR)|4.62|||||TWO_SIDED|95.0|0.41|52.29|||||Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.|Parenteral Cohort B: TIP, Pooled PBO||52.29|0.41|
72330241|NCT02712983|144185584|OTHER||Hazard Ratio (HR)|3.23|||||TWO_SIDED|95.0|0.28|37.06|||||Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.|Parenteral Cohort B: TIP/PBO, Pooled PBO||37.06|0.28|
72330242|NCT02712983|144185584|OTHER||Hazard Ratio (HR)|1.61|||||TWO_SIDED|95.0|0.1|25.94|||||Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.|Parenteral Cohort C: TIP, Pooled PBO||25.94|0.10|
72330243|NCT02712983|144185584|OTHER||Hazard Ratio (HR)|11.3|||||TWO_SIDED|95.0|1.09|117.34|||||Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.|Parenteral Cohort C: TIP/PBO, Pooled PBO||117.34|1.09|
72330244|NCT02712983|144185584|OTHER||Hazard Ratio (HR)|4.3|||||TWO_SIDED|95.0|0.5|37.32|||||Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.|Parenteral Pooled TIP, Pooled PBO||37.32|0.50|
72330245|NCT02712983|144185585|OTHER||LS Mean Diff (SE) vs pooled placebo|9.8|STANDARD_ERROR_OF_MEAN|18.15|||TWO_SIDED|95.0|-27.15|46.81|||||ANCOVA model includes treatment as a fixed-effect factor and number of pulmonary exacerbations in the 12 months prior to screening as a covariate.|Overall Cohort A: TIP, Pooled PBO||46.81|-27.15|
72330246|NCT02712983|144185585|OTHER||LS Mean Diff (SE) vs pooled placebo|19.8|STANDARD_ERROR_OF_MEAN|20.81|||TWO_SIDED|95.0|-22.63|62.14|||||ANCOVA model includes treatment as a fixed-effect factor and number of pulmonary exacerbations in the 12 months prior to screening as a covariate.|Overall Cohort A: TIP/PBO, Pooled PBO||62.14|-22.63|
72330247|NCT02712983|144185585|OTHER||LS Mean Diff (SE) vs pooled placebo|8.0|STANDARD_ERROR_OF_MEAN|19.29|||TWO_SIDED|95.0|-31.32|47.26|||||ANCOVA model includes treatment as a fixed-effect factor and number of pulmonary exacerbations in the 12 months prior to screening as a covariate.|Overall Cohort B: TIP, Pooled PBO||47.26|-31.32|
72330248|NCT02712983|144185585|OTHER||LS Mean Diff (SE) vs pooled placebo|12.7|STANDARD_ERROR_OF_MEAN|19.24|||TWO_SIDED|95.0|-26.49|51.89|||||ANCOVA model includes treatment as a fixed-effect factor and number of pulmonary exacerbations in the 12 months prior to screening as a covariate.|Overall Cohort B: TIP/PBO, Pooled PBO||51.89|-26.49|
72330249|NCT02712983|144185585|OTHER||LS Mean Diff (SE) vs pooled placebo|46.5|STANDARD_ERROR_OF_MEAN|21.17|||TWO_SIDED|95.0|3.37|89.61|||||ANCOVA model includes treatment as a fixed-effect factor and number of pulmonary exacerbations in the 12 months prior to screening as a covariate.|Overall Cohort C: TIP, Pooled PBO||89.61|3.37|
72330250|NCT02712983|144185585|OTHER||LS Mean Diff (SE) vs pooled placebo|3.2|STANDARD_ERROR_OF_MEAN|18.37|||TWO_SIDED|95.0|-34.21|40.64|||||ANCOVA model includes treatment as a fixed-effect factor and number of pulmonary exacerbations in the 12 months prior to screening as a covariate.|Overall Cohort C: TIP/PBO, Pooled PBO||40.64|-34.21|
72330251|NCT02712983|144185585|OTHER||LS Mean Diff (SE) vs pooled placebo|21.4|STANDARD_ERROR_OF_MEAN|14.46|||TWO_SIDED|95.0|-8.03|50.89|||||ANCOVA model includes treatment as a fixed-effect factor and number of pulmonary exacerbations in the 12 months prior to screening as a covariate.|Overall Pooled TIP, Pooled PBO||50.89|-8.03|
72330252|NCT02712983|144185585|OTHER||LS Mean Diff (SE) vs pooled placebo|11.9|STANDARD_ERROR_OF_MEAN|14.44|||TWO_SIDED|95.0|-17.52|41.29|||||ANCOVA model includes treatment as a fixed-effect factor and number of pulmonary exacerbations in the 12 months prior to screening as a covariate.|Overall Pooled TIP/PBO, Pooled PBO||41.29|-17.52|
72330253|NCT02712983|144185590|OTHER||Hazard Ratio (HR)|1.26|||||TWO_SIDED|95.0|0.51|3.13|||||Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.|Overall Cohort A: TIP, Pooled PBO||3.13|0.51|
72330254|NCT02712983|144185590|OTHER||Hazard Ratio (HR)|0.47|||||TWO_SIDED|95.0|0.15|1.46|||||Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.|Overall Cohort A: TIP/PBO, Pooled PBO||1.46|0.15|
72330255|NCT02712983|144185590|OTHER||Hazard Ratio (HR)|1.18|||||TWO_SIDED|95.0|0.44|3.21|||||Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.|Overall Cohort B: TIP, Pooled PBO||3.21|0.44|
72368829|NCT02605122|144247419|OTHER||Achievement of Clinical Cure|62.0|||||TWO_SIDED|95.0|50.0|73.0||No p-value was performed. Study prematurely discontinued. Clopper-Pearson was used to determine confidence intervals.|Clopper-Pearson|||||73|50|
72368830|NCT04603027|144247420|SUPERIORITY||Posterior Mean difference|-5.99|||||TWO_SIDED|95.0|-20.28|7.12||||||||7.12|-20.28|
72368831|NCT04603027|144247420|SUPERIORITY||Posterior Mean difference|-8.35|||||TWO_SIDED|95.0|-22.07|5.04||||||||5.04|-22.07|
72368832|NCT04603027|144247420|SUPERIORITY||Posterior Mean difference|-9.1|||||TWO_SIDED|95.0|-23.22|4.65||||||||4.65|-23.22|
72421702|NCT04858802|144354619|SUPERIORITY||Mean Difference (Final Values)|-0.07|STANDARD_DEVIATION|0.5||0.235|TWO_SIDED|95.0|-0.2|0.0||Paired; the threshold for statistical significance was p = 0.05.|t-test, 2 sided||Difference = PROPEL Contour Sinus Implant mean polyp grade in the ethmoid sinus minus balloon sinus dilation alone mean polyp grade in the ethmoid sinus|Day 90||0.0|-0.2|0.235
72330256|NCT02712983|144185590|OTHER||Hazard Ratio (HR)|0.83|||||TWO_SIDED|95.0|0.32|2.18|||||Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.|Overall Cohort B: TIP/PBO, Pooled PBO||2.18|0.32|
72330257|NCT02712983|144185590|OTHER||Hazard Ratio (HR)|0.35|||||TWO_SIDED|95.0|0.1|1.27|||||Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.|Overall Cohort C: TIP, Pooled PBO||1.27|0.10|
72330258|NCT02712983|144185590|OTHER||Hazard Ratio (HR)|1.13|||||TWO_SIDED|95.0|0.43|2.99|||||Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.|Overall Cohort C: TIP/PBO, Pooled PBO||2.99|0.43|
72330259|NCT02712983|144185590|OTHER||Hazard Ratio (HR)|0.81|||||TWO_SIDED|95.0|0.37|1.76|||||Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.|Overall Pooled TIP, Pooled PBO||1.76|0.37|
72330260|NCT02712983|144185590|OTHER||Hazard Ratio (HR)|0.76|||||TWO_SIDED|95.0|0.36|1.61|||||Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.|Overall Pooled TIP/PBO, Pooled PBO||1.61|0.36|
72330261|NCT02712983|144185590|OTHER||Hazard Ratio (HR)|0.87|||||TWO_SIDED|95.0|0.3|2.55|||||Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.|Oral Cohort A: TIP, Pooled PBO||2.55|0.30|
72330262|NCT02712983|144185590|OTHER||Hazard Ratio (HR)|0.63|||||TWO_SIDED|95.0|0.2|2.03|||||Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.|Oral Cohort A: TIP/PBO, Pooled PBO||2.03|0.20|
72330263|NCT02712983|144185590|OTHER||Hazard Ratio (HR)|1.2|||||TWO_SIDED|95.0|0.4|3.6|||||Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.|Oral Cohort B: TIP, Pooled PBO||3.60|0.40|
72330264|NCT02712983|144185590|OTHER||Hazard Ratio (HR)|0.89|||||TWO_SIDED|95.0|0.31|2.55|||||Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.|Oral Cohort B: TIP/PBO, Pooled PBO||2.55|0.31|
72330265|NCT02712983|144185590|OTHER||Hazard Ratio (HR)|0.28|||||TWO_SIDED|95.0|0.06|1.27|||||Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.|Oral Cohort C: TIP, Pooled PBO||1.27|0.06|
72330266|NCT02712983|144185590|OTHER||Hazard Ratio (HR)|1.3|||||TWO_SIDED|95.0|0.45|3.73|||||Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.|Oral Cohort C: TIP/PBO, Pooled PBO||3.73|0.45|
72330267|NCT02712983|144185590|OTHER||Hazard Ratio (HR)|0.66|||||TWO_SIDED|95.0|0.27|1.6|||||Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.|Oral Pooled TIP, Pooled PBO||1.60|0.27|
72368833|NCT04603027|144247421|SUPERIORITY||Posterior Mean difference|-2.6|||||TWO_SIDED|95.0|-13.91|9.9||||||||9.90|-13.91|
72368834|NCT04603027|144247421|SUPERIORITY||Posterior Mean difference|-3.33|||||TWO_SIDED|95.0|-15.21|8.52||||||||8.52|-15.21|
72368835|NCT04603027|144247421|SUPERIORITY||Posterior Mean difference|0.11|||||TWO_SIDED|95.0|-12.33|11.53||||||||11.53|-12.33|
72368836|NCT04603027|144247422|SUPERIORITY||Posterior Mean difference|-0.69|||||TWO_SIDED|95.0|-1.88|0.46||||||||0.46|-1.88|
72368837|NCT04603027|144247422|SUPERIORITY||Posterior Mean difference|-0.73|||||TWO_SIDED|95.0|-1.82|0.45||||||||0.45|-1.82|
72330268|NCT02712983|144185590|OTHER||Hazard Ratio (HR)|0.9|||||TWO_SIDED|95.0|0.4|2.02|||||Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.|Oral Pooled TIP/PBO, Pooled PBO||2.02|0.40|
72330269|NCT02712983|144185590|OTHER||Hazard Ratio (HR)|3.72|||||TWO_SIDED|95.0|0.84|16.52|||||Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.|Parenteral Cohort A: TIP, Pooled PBO||16.52|0.84|
72330270|NCT02712983|144185590|OTHER||Hazard Ratio (HR)|1.34|||||TWO_SIDED|95.0|0.22|8.16|||||Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.|Parenteral Cohort B: TIP, Pooled PBO||8.16|0.22|
72330271|NCT02712983|144185590|OTHER||Hazard Ratio (HR)|2.15|||||TWO_SIDED|95.0|0.46|10.05|||||Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.|Parenteral Cohort B: TIP/PBO, Pooled PBO||10.05|0.46|
72330272|NCT02712983|144185590|OTHER||Hazard Ratio (HR)|0.5|||||TWO_SIDED|95.0|0.05|4.87|||||Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.|Parenteral Cohort C: TIP, Pooled PBO||4.87|0.05|
72330273|NCT02712983|144185590|OTHER||Hazard Ratio (HR)|2.56|||||TWO_SIDED|95.0|0.53|12.49|||||Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.|Parenteral Cohort C: TIP/PBO, Pooled PBO||12.49|0.53|
72330274|NCT02712983|144185590|OTHER||Hazard Ratio (HR)|1.36|||||TWO_SIDED|95.0|0.33|5.68|||||Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.|Paremteral Pooled TIP, Pooled PBO||5.68|0.33|
72330275|NCT02712983|144185595|OTHER||Odds Ratio, log|5.62|||||TWO_SIDED|95.0|0.83|38.18|||||Generalized linear model assuming the negative binomial distribution including treatment and baseline macrolide use as class-effect factors. The log exposure to study in years is included as an offset variable in the model.|Cohort A (3 capsules o.d.): TIP, Pooled PBO||38.18|0.83|
72330276|NCT02712983|144185595|OTHER||Odds Ratio, log|2.0|||||TWO_SIDED|95.0|0.21|19.16|||||Generalized linear model assuming the negative binomial distribution including treatment and baseline macrolide use as class-effect factors. The log exposure to study in years is included as an offset variable in the model.|Cohort B (5 capsules o.d.): TIP, Pooled PBO||19.16|0.21|
72330277|NCT02712983|144185595|OTHER||Odds Ratio, log|3.05|||||TWO_SIDED|95.0|0.43|21.8|||||Generalized linear model assuming the negative binomial distribution including treatment and baseline macrolide use as class-effect factors. The log exposure to study in years is included as an offset variable in the model.|Cohort B (5 capsules o.d.): TIP/PBO, Pooled PBO||21.80|0.43|
72330278|NCT02712983|144185595|OTHER||Odds Ratio, log|1.84|||||TWO_SIDED|95.0|0.19|17.42|||||Generalized linear model assuming the negative binomial distribution including treatment and baseline macrolide use as class-effect factors. The log exposure to study in years is included as an offset variable in the model.|Cohort C (4 capsules b.i.d.): TIP, Pooled PBO||17.42|0.19|
72330279|NCT02712983|144185595|OTHER||Odds Ratio, log|3.41|||||TWO_SIDED|95.0|0.47|25.03|||||Generalized linear model assuming the negative binomial distribution including treatment and baseline macrolide use as class-effect factors. The log exposure to study in years is included as an offset variable in the model.|Cohort C (4 capsules b.i.d.): TIP/PBO, Pooled PBO||25.03|0.47|
72330280|NCT02712983|144185595|OTHER||Odds Ratio, log|2.74|||||TWO_SIDED|95.0|0.47|16.07|||||Generalized linear model assuming the negative binomial distribution including treatment and baseline macrolide use as class-effect factors. The log exposure to study in years is included as an offset variable in the model.|||16.07|0.47|
72330281|NCT02712983|144185596|OTHER||Hazard Ratio (HR)|4.5|||||TWO_SIDED|95.0|0.77|26.42|||||Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.|Cohort A (3 capsules o.d.): TIP, Pooled PBO||26.42|0.77|
72421703|NCT04858802|144354619|SUPERIORITY||Mean Difference (Final Values)|-0.02|STANDARD_DEVIATION|0.41||0.677|TWO_SIDED|95.0|-0.1|0.1||Paired; the threshold for statistical significance was p = 0.05.|t-test, 2 sided||Difference = PROPEL Contour Sinus Implant mean polyp grade in the ethmoid sinus minus balloon sinus dilation alone mean polyp grade in the ethmoid sinus|Day 180||0.1|-0.1|0.677
72330282|NCT02712983|144185596|OTHER||Hazard Ratio (HR)|2.0|||||TWO_SIDED|95.0|0.28|14.47|||||Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.|Cohort B (5 capsules o.d.): TIP, Pooled PBO||14.47|0.28|
72330283|NCT02712983|144185596|OTHER||Hazard Ratio (HR)|1.54|||||TWO_SIDED|95.0|0.2|11.6|||||Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.|Cohort B (5 capsules o.d.): TIP/PBO, Pooled PBO||11.60|0.20|
72330284|NCT02712983|144185596|OTHER||Hazard Ratio (HR)|0.67|||||TWO_SIDED|95.0|0.06|7.49|||||Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.|Cohort C (4 capsules b.i.d.): TIP, Pooled PBO||7.49|0.06|
72330285|NCT02712983|144185596|OTHER||Hazard Ratio (HR)|3.81|||||TWO_SIDED|95.0|0.62|23.29|||||Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.|Cohort C (4 capsules b.i.d.): TIP/PBO, Pooled PBO||23.29|0.62|
72330286|NCT02712983|144185596|OTHER||Hazard Ratio (HR)|1.82|||||TWO_SIDED|95.0|0.35|9.45|||||Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.|Pooled TIP, Pooled PBO||9.45|0.35|
72330287|NCT05360966|144185611|OTHER|Difference (2-sided)|Difference in Percentages|38.8|||<|0.0001|TWO_SIDED|95.0|30.8|46.8||Multiple imputation methodology was implemented in handling missing data, both related to and unrelated to intercurrent events.|Pearson's Chi-squared test||Difference equals 0.003% AR-15512 minus AR-15512 Vehicle|The primary estimand targeted the treatment effect attributable to the randomly assigned treatment, regardless of compliance to study treatment and assuming subjects who discontinued due to lack of efficacy, AEs, or disallowed concurrent treatments followed the behavior of subjects in the reference arm for the duration of the study and subjects who discontinued for other reasons would have followed the behavior of subjects who were still in the study under same randomly assigned treatment.|For binary endpoint, the underlying continuous measurement of unanesthetized Schirmer score was imputed, change score calculated and then dichotomized to ascertain attainment of greater than or equal to 10 millimeter increase from pre-drop baseline.|46.8|30.8|<0.0001
72330288|NCT05360966|144185612|OTHER|Difference (2-sided)|Least Squares Mean Difference|-3.1|STANDARD_ERROR_OF_MEAN|2.08||0.1321|TWO_SIDED|95.0|-7.2|0.9||Multiple imputation methodology was implemented in handling missing data, both related to and unrelated to intercurrent events.|ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center.|Difference equals 0.003% AR-15512 minus AR-15512 Vehicle|The primary estimand targeted the treatment effect attributable to the randomly assigned treatment, regardless of compliance to study treatment and assuming subjects who discontinued due to lack of efficacy, AEs, or disallowed concurrent treatments followed the behavior of subjects in the reference arm for the duration of the study and subjects who discontinued for other reasons would have followed the behavior of subjects who were still in the study under same randomly assigned treatment.||0.9|-7.2|0.1321
72330289|NCT05360966|144185613|OTHER|Difference (2-sided)|Least Squares Mean Difference|8.3|STANDARD_ERROR_OF_MEAN|0.75|<|0.0001|TWO_SIDED|95.0|6.9|9.8||Multiple imputation methodology was implemented in handling missing data, both related to and unrelated to intercurrent events.|ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center|Difference equals 0.003% AR-15512 minus AR-15512 Vehicle|The primary estimand targeted the treatment effect attributable to the randomly assigned treatment, regardless of compliance to study treatment and assuming subjects who discontinued due to lack of efficacy, AEs, or disallowed concurrent treatments followed the behavior of subjects in the reference arm for the duration of the study and subjects who discontinued for other reasons would have followed the behavior of subjects who were still in the study under same randomly assigned treatment.||9.8|6.9|<0.0001
72330290|NCT05360966|144185614|OTHER|Difference (2-sided)|Difference in Percentages|40.1|||<|0.0001|TWO_SIDED|95.0|32.3|47.9||Multiple imputation methodology was implemented in handling missing data, both related to and unrelated to intercurrent events.|Pearson's Chi-squared test||Difference equals 0.003% AR-15512 minus AR-15512 Vehicle|The primary estimand targeted the treatment effect attributable to the randomly assigned treatment, regardless of compliance to study treatment and assuming subjects who discontinued due to lack of efficacy, AEs, or disallowed concurrent treatments followed the behavior of subjects in the reference arm for the duration of the study and subjects who discontinued for other reasons would have followed the behavior of subjects who were still in the study under same randomly assigned treatment.|For binary endpoint, the underlying continuous measurement of unanesthetized Schirmer score was imputed, change score calculated and then dichotomized to ascertain attainment of greater than or equal to 10 millimeter increase from pre-drop baseline.|47.9|32.3|<0.0001
72368838|NCT04603027|144247422|SUPERIORITY||Posterior Mean difference|-0.81|||||TWO_SIDED|95.0|-2.05|0.33||||||||0.33|-2.05|
72368839|NCT04603027|144247423|SUPERIORITY||Odds Ratio (OR)|2.64|||||TWO_SIDED|95.0|1.01|6.94||||||||6.94|1.01|
72368840|NCT04603027|144247423|SUPERIORITY||Odds Ratio (OR)|2.93|||||TWO_SIDED|95.0|1.17|7.37||||||||7.37|1.17|
72368841|NCT04603027|144247423|SUPERIORITY||Odds Ratio (OR)|1.73|||||TWO_SIDED|95.0|0.63|4.7||||||||4.70|0.63|
72330291|NCT05360966|144185615|OTHER|Difference (2-sided)|Least Squares Mean Difference|7.6|STANDARD_ERROR_OF_MEAN|0.67|<|0.0001|TWO_SIDED|95.0|6.3|8.9||Multiple imputation methodology was implemented in handling missing data, both related to and unrelated to intercurrent events.|ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center|Difference equals 0.003% AR-15512 minus AR-15512 Vehicle|The primary estimand targeted the treatment effect attributable to the randomly assigned treatment, regardless of compliance to study treatment and assuming subjects who discontinued due to lack of efficacy, AEs, or disallowed concurrent treatments followed the behavior of subjects in the reference arm for the duration of the study and subjects who discontinued for other reasons would have followed the behavior of subjects who were still in the study under same randomly assigned treatment.||8.9|6.3|<0.0001
72330292|NCT05360966|144185616|OTHER|Difference (2 sided)|Difference in Percentages|37.3|||<|0.0001|TWO_SIDED|95.0|28.7|45.9||Multiple imputation methodology was implemented in handling missing data, both related to and unrelated to intercurrent events.|Pearson's Chi-squared test||Difference equals 0.003% AR-15512 minus AR-15512 Vehicle|The primary estimand targeted the treatment effect attributable to the randomly assigned treatment, regardless of compliance to study treatment and assuming subjects who discontinued due to lack of efficacy, AEs, or disallowed concurrent treatments followed the behavior of subjects in the reference arm for the duration of the study and subjects who discontinued for other reasons would have followed the behavior of subjects who were still in the study under same randomly assigned treatment.|For binary endpoint, the underlying continuous measurement of unanesthetized Schirmer score was imputed, change score calculated and then dichotomized to ascertain attainment of greater than or equal to 10 millimeter increase from pre-drop baseline.|45.9|28.7|<0.0001
72330293|NCT05360966|144185617|OTHER|Difference (2-sided)|Least Squares Mean Difference|8.1|STANDARD_ERROR_OF_MEAN|0.78|<|0.0001|TWO_SIDED|95.0|6.5|9.6||Multiple imputation methodology was implemented in handling missing data, both related to and unrelated to intercurrent events.|ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center|Difference equals 0.003% AR-15512 minus AR-15512 Vehicle|The primary estimand targeted the treatment effect attributable to the randomly assigned treatment, regardless of compliance to study treatment and assuming subjects who discontinued due to lack of efficacy, AEs, or disallowed concurrent treatments followed the behavior of subjects in the reference arm for the duration of the study and subjects who discontinued for other reasons would have followed the behavior of subjects who were still in the study under same randomly assigned treatment.||9.6|6.5|<0.0001
72330294|NCT05360966|144185618|OTHER|Difference (2-sided)|Least Squares Mean Difference|-1.4|STANDARD_ERROR_OF_MEAN|2.4||0.5626|TWO_SIDED|95.0|-6.1|3.3||Multiple imputation methodology was implemented in handling missing data, both related to and unrelated to intercurrent events.|ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center|Difference equals 0.003% AR-15512 minus AR-15512 Vehicle|The primary estimand targeted the treatment effect attributable to the randomly assigned treatment, regardless of compliance to study treatment and assuming subjects who discontinued due to lack of efficacy, AEs, or disallowed concurrent treatments followed the behavior of subjects in the reference arm for the duration of the study and subjects who discontinued for other reasons would have followed the behavior of subjects who were still in the study under same randomly assigned treatment.||3.3|-6.1|0.5626
72330295|NCT05360966|144185619|OTHER|Difference (2-sided)|Least Squares Mean Difference|-1.3|STANDARD_ERROR_OF_MEAN|2.53||0.5981|TWO_SIDED|95.0|-6.3|3.6||Multiple imputation methodology was implemented in handling missing data, both related to and unrelated to intercurrent events.|ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center|Difference equals 0.003% AR-15512 minus AR-15512 Vehicle|The primary estimand targeted the treatment effect attributable to the randomly assigned treatment, regardless of compliance to study treatment and assuming subjects who discontinued due to lack of efficacy, AEs, or disallowed concurrent treatments followed the behavior of subjects in the reference arm for the duration of the study and subjects who discontinued for other reasons would have followed the behavior of subjects who were still in the study under same randomly assigned treatment.||3.6|-6.3|0.5981
72330296|NCT05360966|144185620|OTHER|Difference (2-sided)|Least Squares Mean Difference|-1.6|STANDARD_ERROR_OF_MEAN|2.44||0.5161|TWO_SIDED|95.0|-6.4|3.2||Multiple imputation methodology was implemented in handling missing data, both related to and unrelated to intercurrent events.|ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center|Difference equals 0.003% AR-15512 minus AR-15512 Vehicle|The primary estimand targeted the treatment effect attributable to the randomly assigned treatment, regardless of compliance to study treatment and assuming subjects who discontinued due to lack of efficacy, AEs, or disallowed concurrent treatments followed the behavior of subjects in the reference arm for the duration of the study and subjects who discontinued for other reasons would have followed the behavior of subjects who were still in the study under same randomly assigned treatment.||3.2|-6.4|0.5161
72368842|NCT04603027|144247424|SUPERIORITY|||||||0.1|||||||nonparametric survival analysis|Method used was a nonparametric survival analysis for interval censored data||||||0.100
72368843|NCT04603027|144247424|SUPERIORITY|||||||0.034|||||||nonparametric survival analysis|Method used was a nonparametric survival analysis for interval censored data||||||0.034
72368844|NCT04603027|144247424|SUPERIORITY|||||||0.094|||||||nonparametric survival analysis|Method used was a nonparametric survival analysis for interval censored data||||||0.094
72368845|NCT04603027|144247428|SUPERIORITY||Posterior Mean Odds Ratio|2.14|||||TWO_SIDED|95.0|0.45|10.96||||||||10.96|0.45|
72368846|NCT04603027|144247428|SUPERIORITY||Posterior Mean Odds Ratio|2.02|||||TWO_SIDED|95.0|0.42|8.78||||||||8.78|0.42|
72368847|NCT04603027|144247428|SUPERIORITY||Posterior Mean Odds Ratio|2.12|||||TWO_SIDED|95.0|0.46|9.51||||||||9.51|0.46|
72368848|NCT04603027|144247429|SUPERIORITY||||||||||||||||||There were not enough responders to model using GLMM or a Bayesian logistic model, and no treatment difference analysis was conducted.|||
72421704|NCT04858802|144354620|SUPERIORITY||Mean Difference (Final Values)|-0.06|STANDARD_DEVIATION|2.48||0.868|TWO_SIDED|95.0|-0.7|0.6||Paired; the threshold for statistical significance was p = 0.05.|t-test, 2 sided||Difference = PROPEL Contour Sinus Implant mean CRS side-specific symptom total score minus balloon sinus dilation alone mean CRS side-specific symptom total score|Day 21||0.6|-0.7|0.868
72421705|NCT04858802|144354620|SUPERIORITY||Mean Difference (Final Values)|0.07|STANDARD_DEVIATION|2.3||0.823|TWO_SIDED|95.0|-0.5|0.7||Paired; the threshold for statistical significance was p = 0.05.|t-test, 2 sided||Difference = PROPEL Contour Sinus Implant mean CRS side-specific symptom total score minus balloon sinus dilation alone mean CRS side-specific symptom total score|Day 45||0.7|-0.5|0.823
72421706|NCT04858802|144354620|SUPERIORITY||Mean Difference (Final Values)|0.0|STANDARD_DEVIATION|2.26||1|TWO_SIDED|95.0|-0.5|0.5||Paired; the threshold for statistical significance was p = 0.05.|t-test, 2 sided||Difference = PROPEL Contour Sinus Implant mean CRS side-specific symptom total score minus balloon sinus dilation alone mean CRS side-specific symptom total score|Day 90||0.5|-0.5|1.00
72421707|NCT04858802|144354620|SUPERIORITY||Mean Difference (Final Values)|-0.33|STANDARD_DEVIATION|2.16||0.188|TWO_SIDED|95.0|-0.8|0.2||Paired; the threshold for statistical significance was p = 0.05.|t-test, 2 sided||Difference = PROPEL Contour Sinus Implant mean CRS side-specific symptom total score minus balloon sinus dilation alone mean CRS side-specific symptom total score|Day 180||0.2|-0.8|0.188
72330297|NCT05360966|144185621|OTHER|Difference (2-sided)|Least Squares Mean Difference|0.5|STANDARD_ERROR_OF_MEAN|2.51||0.8574|TWO_SIDED|95.0|-4.5|5.4||Multiple imputation methodology was implemented in handling missing data, both related to and unrelated to intercurrent events.|ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center|Difference equals 0.003% AR-15512 minus AR-15512 Vehicle|The primary estimand targeted the treatment effect attributable to the randomly assigned treatment, regardless of compliance to study treatment and assuming subjects who discontinued due to lack of efficacy, AEs, or disallowed concurrent treatments followed the behavior of subjects in the reference arm for the duration of the study and subjects who discontinued for other reasons would have followed the behavior of subjects who were still in the study under same randomly assigned treatment.||5.4|-4.5|0.8574
72421708|NCT04858802|144354624|SUPERIORITY||Mean Difference (Net)|6.28|STANDARD_DEVIATION|18.12||0.025|TWO_SIDED|95.0|0.8|11.7||Paired; the threshold for statistical significance was p = 0.05.|t-test, 2 sided||Difference = PROPEL Contour Sinus Implant mean FSO cross-sectional area minus balloon sinus dilation alone mean FSO cross-sectional area|||11.7|0.8|0.025
72421709|NCT04858802|144354625|SUPERIORITY||Mean Difference (Final Values)|3.98|STANDARD_DEVIATION|12.49||0.04|TWO_SIDED|95.0|0.2|7.8||Paired; the threshold for statistical significance was p = 0.05.|t-test, 2 sided||Difference = PROPEL Contour Sinus Implant mean FSO cross-sectional area change from baseline to Day 45 minus balloon sinus dilation alone mean FSO cross-sectional area change from baseline to Day 45|Day 45||7.8|0.2|0.04
72330298|NCT05360966|144185622|OTHER|Difference (2-sided)|Least Squares Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|2.69||0.698|TWO_SIDED|95.0|-6.3|4.2||Multiple imputation methodology was implemented in handling missing data, both related to and unrelated to intercurrent events.|ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center|Difference equals 0.003% AR-15512 minus AR-15512 Vehicle|The primary estimand targeted the treatment effect attributable to the randomly assigned treatment, regardless of compliance to study treatment and assuming subjects who discontinued due to lack of efficacy, AEs, or disallowed concurrent treatments followed the behavior of subjects in the reference arm for the duration of the study and subjects who discontinued for other reasons would have followed the behavior of subjects who were still in the study under same randomly assigned treatment.||4.2|-6.3|0.6980
72330299|NCT01477710|144185664|SUPERIORITY_OR_OTHER_LEGACY||ANOVA F-value|266.39|||<|0.0001||||||This p-value is for the omnibus F-test of between-treatment differences in tidal volume|ANOVA|The p-value for the omnibus F-test was \<0.0001||Using ANOVA, pairwise comparisons of treatment means were made using a Tukey adjustment for multiple comparisons.||||<0.0001
72330300|NCT01477710|144185664|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|314.4|||<|0.0001||95.0|264.7|364.1|||t-test, 2 sided|||||364.1|264.7|<0.0001
72330301|NCT01477710|144185664|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|576.6|STANDARD_ERROR_OF_MEAN|25.0|<|0.0001|TWO_SIDED|95.0|526.9|626.3|||t-test, 2 sided|||||626.3|526.9|<0.0001
72330302|NCT01477710|144185664|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|262.2|STANDARD_DEVIATION|25.0|<|0.0001|TWO_SIDED|95.0|212.5|312.0|||t-test, 2 sided|||||312.0|212.5|<0.0001
72330303|NCT00241176|144185757|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.003|||<|0.05|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)||YGTSS Global Severity score (M=61.8 SD=13.49) declined significantly to end point (M=33.7 SD=15.18; p=0.003).|Group 1 Baseline vs. Endpoint||||<.05
72330304|NCT00241176|144185758|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.004|||<|0.05||95.0|||||Wilcoxon (Mann-Whitney)||Mean (SD) CGI-Tic severity scores reduced significantly from (M=4.45 SD=0.52) (moderate-marked) at baseline to (M=3.18 SD =0.60) (mild) at end point ( p=0.004).|Mean scores baseline to endpoint||||<.05
72330305|NCT03206970|144185776|OTHER||Clopper-Pearson|83.7|||<|0.0001|TWO_SIDED|95.0|74.2|90.8|||Binomial Exact Test|||A binomial exact test was performed to test against the null hypothesis H0: ORR=0.40 using the significant level of 0.025 (1-sided)||90.8|74.2|<.0001
72330306|NCT03206970|144185780|SUPERIORITY||Clopper-Pearson|83.7|||<|0.0001|TWO_SIDED|95.0|74.2|90.8|||Binomial Exact Test|||A binomial exact test was performed to test against the null hypothesis H0: ORR=0.40 using the significant level of 0.025 (1-sided)||90.8|74.2|<0.0001
72330307|NCT02516982|144185785|SUPERIORITY|||||||0.994|||||||Chi-squared, Corrected|||||||0.994
72330308|NCT02516982|144185786|SUPERIORITY|||||||0.7|||||||Wilcoxon (Mann-Whitney)|||||||0.7
72330309|NCT02516982|144185787|SUPERIORITY|||||||0.008|||||||Chi-squared, Corrected|||||||0.008
72330310|NCT02516982|144185788|SUPERIORITY|||||||0.919|||||||Chi-squared, Corrected|||||||0.919
72330311|NCT02516982|144185789|SUPERIORITY|||||||0.0001467|||||||Chi-squared, Corrected|||||||0.0001467
72330312|NCT02516982|144185790|SUPERIORITY|||||||0.024|||||||Wilcoxon (Mann-Whitney)|||||||0.024
72330313|NCT02516982|144185791|SUPERIORITY|||||||0.869|||||||Chi-squared, Corrected|||||||0.869
72330314|NCT01129765|144185793|SUPERIORITY_OR_OTHER||Proportion|0.97|||||TWO_SIDED|95.0|0.83|1.0|||Descriptive|||Proportion responding \>=3 on a 5-point likert scale, with exact 95% confidence interval from the binomial distribution.||1.0|0.83|
72330315|NCT01129765|144185794|SUPERIORITY_OR_OTHER||Proportion|0.97|||||TWO_SIDED|95.0|0.83|1.0|||Descriptive|||Descriptive summary of proportion responding \>=3 on 5-point Likert scale, with exact 95% confidnce interval from the binomial distribution.||1.0|0.83|
72330316|NCT01129765|144185795|SUPERIORITY_OR_OTHER||Proportion|0.97||||0.0005|TWO_SIDED|95.0|0.83|1.0|||One-sample proportion|||"Null hypothesis: Pr ≤ 0.7 versus HA: Pr \> 0.7; Pr is proportion using device appropriately. Observed rate calculated with exact 95% confidence interval from the binomial distribution. 2-sided p-value from binomial distribution.~With the proposed sample size of 30 subjects, we will reject the primary null hypothesis if at least 27 are observed to use the device properly. We will have 80% power for this to occur provided that the true rate in the population is at least 92%."||1.0|0.83|0.0005
72330317|NCT01129765|144185796|SUPERIORITY_OR_OTHER||Proportion|1.0|||||TWO_SIDED|95.0|0.88|1.0|||Descriptive|||Descriptive summary of proportion responding \>=3 on a 5-point Likert scale, with exact 95% confidnce interval from the binomial distribution.||1.0|0.88|
72330318|NCT01129765|144185797|SUPERIORITY_OR_OTHER||Proportion|0.0|||||TWO_SIDED|95.0|0.0|0.12|||Descriptive|||Descriptive summary of proportion observed to have a safety issue, with exact 95% confidnce interval from the binomial distribution.||0.12|0|
72330319|NCT01129765|144185798|SUPERIORITY_OR_OTHER||Proportion|0.0|||||TWO_SIDED|95.0|0.0|0.12|||Descriptive|||Descriptive summary of proportion found to have injury, with exact 95% confidnce interval from the binomial distribution.||0.12|0|
72330320|NCT01814878|144185890|NON_INFERIORITY_OR_EQUIVALENCE|Study drug treatment group was considered non-inferior to comparator treatment group, if lower limit of the confidence interval was larger than -2.0|Mean Difference (Final Values)|-4.68||||0.1648|TWO_SIDED|95.0|-11.29|1.93||Hour 48: P-value was calculated using Student's t-test|Student's t-test|||Non-inferiority comparison for Tramadol Hydrochloride/Acetaminophen ER to Tramadol HCl/Acetaminophen IR was performed.||1.93|-11.29|0.1648
72330321|NCT01814878|144185891|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.32||||0.4082|TWO_SIDED|95.0|-1.1|0.45||Hour 6: P-value was calculated using Student's t-test|Student's t-test|||||0.45|-1.10|0.4082
72330322|NCT01814878|144185891|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.1||||0.172|TWO_SIDED|95.0|-2.68|0.48||Hour 12: P-value was calculated using Student's t-test|Student's t-test|||||0.48|-2.68|0.1720
72330323|NCT01814878|144185891|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.99||||0.0589|TWO_SIDED|95.0|-6.09|0.11||Hour 24: P-value was calculated using Student's t-test|Student's t-test|||||0.11|-6.09|0.0589
72330324|NCT01814878|144185892|SUPERIORITY_OR_OTHER|||||||0.1542||||||Hour 6: P-value was calculated using Student's t-test|Student's t-test|||||||0.1542
72330325|NCT01814878|144185892|SUPERIORITY_OR_OTHER|||||||0.0714||||||Hour 12: P-value was calculated using Student's t-test|Student's t-test|||||||0.0714
72330326|NCT01814878|144185892|SUPERIORITY_OR_OTHER|||||||0.1147||||||Hour 24: P-value was calculated using Student's t-test|Student's t-test|||||||0.1147
72330327|NCT01814878|144185892|SUPERIORITY_OR_OTHER|||||||0.2209||||||Hour 48: P-value was calculated using Student's t-test|Student's t-test|||||||0.2209
72330328|NCT01814878|144185893|SUPERIORITY_OR_OTHER|||||||0.1498||||||Hour 6: P-value was calculated using Student's t-test|Student's t-test|||||||0.1498
72330329|NCT01814878|144185893|SUPERIORITY_OR_OTHER|||||||0.0485||||||Hour 12: P-value was calculated using Student's t-test|Student's t-test|||||||0.0485
72330330|NCT01814878|144185893|SUPERIORITY_OR_OTHER|||||||0.0404||||||Hour 24: P-value was calculated using Student's t-test|Student's t-test|||||||0.0404
72330331|NCT01814878|144185893|SUPERIORITY_OR_OTHER|||||||0.121||||||Hour 48: P-value was calculated using Student's t-test|Student's t-test|||||||0.1210
72330332|NCT01814878|144185894|SUPERIORITY_OR_OTHER|||||||0.4216||||||P-value was calculated using Mann-Whitney's U test.|Wilcoxon (Mann-Whitney)|||||||0.4216
72330333|NCT01814878|144185895|SUPERIORITY_OR_OTHER|||||||0.1||||||P-value was calculated using Mann-Whitney's U test.|Wilcoxon (Mann-Whitney)|||||||0.1000
72330334|NCT01814878|144185896|SUPERIORITY_OR_OTHER|||||||0.3255||||||P-value was calculated using Mann-Whitney's U test.|Wilcoxon (Mann-Whitney)|||||||0.3255
72330335|NCT01814878|144185897|SUPERIORITY_OR_OTHER|||||||0.2848||||||Day 3: P-value was calculated using student's t-test|Student's t-test|||||||0.2848
72330336|NCT03645421|144185900|OTHER||Least squares (LS) mean difference|-42.11|STANDARD_ERROR_OF_MEAN|4.16|<|0.0001|TWO_SIDED|95.0|-50.47|-33.75|||ANCOVA|Analysis used treatment group as a factor and baseline as a covariate.|Treatment difference = MEDI0382 100 mcg - Placebo|Pair-wise comparison of MEDI0382 100 mcg versus Placebo.||-33.75|-50.47|<0.0001
72330337|NCT03645421|144185900|OTHER||LS mean difference|-33.61|STANDARD_ERROR_OF_MEAN|4.69|<|0.0001|TWO_SIDED|95.0|-43.04|-24.18|||ANCOVA|Analysis used treatment group as a factor and baseline as a covariate.|Treatment difference = MEDI0382 200 mcg - Placebo|Pair-wise comparison of MEDI0382 200 mcg versus Placebo.||-24.18|-43.04|<0.0001
72330338|NCT03645421|144185900|OTHER||LS mean difference|-40.3|STANDARD_ERROR_OF_MEAN|4.57|<|0.0001|TWO_SIDED|95.0|-49.49|-31.12|||ANCOVA|Analysis used treatment group as a factor and baseline as a covariate.|Treatment difference = MEDI0382 300 mcg - Placebo|Pair-wise comparison of MEDI0382 300 mcg versus Placebo.||-31.12|-49.49|<0.0001
72330339|NCT03645421|144185901|OTHER||LS mean difference|-1.3|STANDARD_ERROR_OF_MEAN|0.89||0.1476|TWO_SIDED|95.0|-3.08|0.47|||ANCOVA|Analysis used treatment group as a factor and baseline as a covariate.|Treatment difference = MEDI0382 100 mcg - Placebo|Pair-wise comparison of MEDI0382 100 mcg versus Placebo.||0.47|-3.08|0.1476
72330340|NCT03645421|144185901|OTHER||LS mean difference|-2.53|STANDARD_ERROR_OF_MEAN|0.92||0.008|TWO_SIDED|95.0|-4.37|-0.69|||ANCOVA|Analysis used treatment group as a factor and baseline as a covariate.|Treatment difference = MEDI0382 200 mcg - Placebo|Pair-wise comparison of MEDI0382 200 mcg versus Placebo.||-0.69|-4.37|0.0080
72330341|NCT03645421|144185901|OTHER||LS mean difference|-2.52|STANDARD_ERROR_OF_MEAN|0.89||0.0063|TWO_SIDED|95.0|-4.3|-0.74|||ANCOVA|Analysis used treatment group as a factor and baseline as a covariate.|Treatment difference = MEDI0382 300 mcg - Placebo|Pair-wise comparison of MEDI0382 300 mcg versus Placebo.||-0.74|-4.30|0.0063
72330342|NCT03645421|144185904|OTHER||LS mean difference|-1.09|STANDARD_ERROR_OF_MEAN|0.19|<|0.0001|TWO_SIDED|95.0|-1.48|-0.7|||ANCOVA|Analysis used treatment group as a factor and baseline as a covariate.|Treatment difference = MEDI0382 100 mcg - Placebo|Pair-wise comparison of MEDI0382 100 mcg versus Placebo.||-0.70|-1.48|<0.0001
72330343|NCT03645421|144185904|OTHER||LS mean difference|-1.1|STANDARD_ERROR_OF_MEAN|0.19|<|0.0001|TWO_SIDED|95.0|-1.49|-0.71|||ANCOVA|Analysis used treatment group as a factor and baseline as a covariate.|Treatment difference = MEDI0382 200 mcg - Placebo|Pair-wise comparison of MEDI0382 200 mcg versus Placebo.||-0.71|-1.49|<0.0001
72421710|NCT04858802|144354625|SUPERIORITY||Median Difference (Final Values)|-3.45|STANDARD_DEVIATION|13.02||0.09|TWO_SIDED|95.0|-7.5|0.6||Paired; the threshold for statistical significance was p = 0.05.|t-test, 2 sided||Difference = PROPEL Contour Sinus Implant mean FSO cross-sectional area change from baseline to Day 180 minus balloon sinus dilation alone mean FSO cross-sectional area change from baseline to Day 180|Day 180||0.6|-7.5|0.09
72330344|NCT03645421|144185904|OTHER||LS mean difference|-0.76|STANDARD_ERROR_OF_MEAN|0.19||0.0002|TWO_SIDED|95.0|-1.15|-0.38|||ANCOVA|Analysis used treatment group as a factor and baseline as a covariate.|Treatment difference = MEDI0382 300 mcg - Placebo|Pair-wise comparison of MEDI0382 300 mcg versus Placebo.||-0.38|-1.15|0.0002
72330345|NCT03645421|144185905|OTHER||LS mean difference|-56.69|STANDARD_ERROR_OF_MEAN|8.75|<|0.0001|TWO_SIDED|95.0|-74.3|-39.09|||ANCOVA|Analysis used treatment group as a factor and baseline as a covariate.|Treatment difference = MEDI0382 100 mcg - Placebo|Pair-wise comparison of MEDI0382 100 mcg versus Placebo.||-39.09|-74.30|<0.0001
72330346|NCT03645421|144185905|OTHER||LS mean difference|-60.58|STANDARD_ERROR_OF_MEAN|9.92|<|0.0001|TWO_SIDED|95.0|-80.53|-40.63|||ANCOVA|Analysis used treatment group as a factor and baseline as a covariate.|Treatment difference = MEDI0382 200 mcg - Placebo|Pair-wise comparison of MEDI0382 200 mcg versus Placebo.||-40.63|-80.53|<0.0001
72330347|NCT03645421|144185905|OTHER||LS mean difference|-55.07|STANDARD_ERROR_OF_MEAN|9.55|<|0.0001|TWO_SIDED|95.0|-74.28|-35.86|||ANCOVA|Analysis used treatment group as a factor and baseline as a covariate.|Treatment difference = MEDI0382 300 mcg - Placebo|Pair-wise comparison of MEDI0382 300 mcg versus Placebo.||-35.86|-74.28|<0.0001
72330348|NCT03645421|144185906|OTHER||LS mean difference|-0.071|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|-0.094|-0.047|||ANCOVA|Analysis used treatment group as a factor and baseline as a covariate.|Treatment difference = MEDI0382 100 mcg - Placebo|Pair-wise comparison of MEDI0382 100 mcg versus Placebo.||-0.047|-0.094|<0.0001
72330349|NCT03645421|144185906|OTHER||LS mean difference|-0.053|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|-0.077|-0.03|||ANCOVA|Analysis used treatment group as a factor and baseline as a covariate.|Treatment difference = MEDI0382 200 mcg - Placebo|Pair-wise comparison of MEDI0382 200 mcg versus Placebo.||-0.030|-0.077|<0.0001
72330350|NCT03645421|144185906|OTHER||LS mean difference|-0.049|STANDARD_ERROR_OF_MEAN|0.012||0.0002|TWO_SIDED|95.0|-0.074|-0.024|||ANCOVA|Analysis used treatment group as a factor and baseline as a covariate.|Treatment difference = MEDI0382 300 mcg - Placebo|Pair-wise comparison of MEDI0382 300 mcg versus Placebo.||-0.024|-0.074|0.0002
72330351|NCT02253433|144185918|SUPERIORITY||Mean Difference (Final Values)|0.6||||0.575|TWO_SIDED|95.0|-0.87|2.07|||Mixed Models Analysis|||||2.07|-.87|0.575
72330352|NCT02253433|144185919|SUPERIORITY||Mean Difference (Final Values)|0.25||||0.141|TWO_SIDED|95.0|-0.18|0.68|||Mixed Models Analysis|||||.68|-.18|0.141
72330353|NCT02253433|144185920|SUPERIORITY||Odds Ratio (OR)|0.86||||0.043|TWO_SIDED|95.0|0.47|1.57|||Mixed Models Analysis|ED visits over the previous 12 months were positively skewed (skewness 2.95; kurtosis 14.1); the responses were dichotomized (0 vs. 1 or more).||||1.57|.47|0.043
72330354|NCT03985943|144185941|OTHER||Strata-adjusted percentage difference|11.5||||0.0003|TWO_SIDED|97.5|4.7|18.3||Strata-adjusted p-values were calculated from Cochran-Mantel-Haenszel test adjusting randomized stratification variables (IGA severity \[3=moderate, 4=severe\] and PP NRS \[\>=7, \<7\]).|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control the overall type I error. Testing was performed sequentially in order the outcome measures were reported and continued when the test for the preceding outcome measure was statistically significant at two-sided 2.5% significance level.||18.3|4.7|0.0003
72330355|NCT03985943|144185942|OTHER||Strata-adjusted percentage difference|14.3||||0.0002|TWO_SIDED|97.5|6.1|22.5||Strata-adjusted p-values were calculated from Cochran-Mantel-Haenszel test adjusting randomized stratification variables (IGA severity \[3=moderate, 4=severe\]).|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control the overall type I error. Testing was performed sequentially in order the outcome measures were reported and continued when the test for the preceding outcome measure was statistically significant at two-sided 2.5% significance level.||22.5|6.1|0.0002
72330356|NCT03985943|144185943|OTHER||Strata-adjusted percentage difference|14.9|||<|0.0001|TWO_SIDED|97.5|7.8|22.0||Strata-adjusted p-values were calculated from Cochran-Mantel-Haenszel test adjusting randomized stratification variables (IGA severity \[3=moderate, 4=severe\] and PP NRS \[\>=7, \<7\]).|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control the overall type I error. Testing was performed sequentially in order the outcome measures were reported and continued when the test for the preceding outcome measure was statistically significant at two-sided 2.5% significance level.||22.0|7.8|<0.0001
72330357|NCT03985943|144185944|OTHER||Strata-adjusted percentage difference|18.1|||<|0.0001|TWO_SIDED|97.5|9.6|26.6||Strata-adjusted p-values were calculated from Cochran-Mantel-Haenszel test adjusting randomized stratification variables (IGA severity \[3=moderate, 4=severe\]).|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control the overall type I error. Testing was performed sequentially in order the outcome measures were reported and continued when the test for the preceding outcome measure was statistically significant at two-sided 2.5% significance level.||26.6|9.6|<0.0001
72330358|NCT03985943|144185945|OTHER||Strata-adjusted percentage difference|24.9|||<|0.0001|TWO_SIDED|97.5|18.4|31.5||Strata-adjusted p-values were calculated from Cochran-Mantel-Haenszel test adjusting randomized stratification variables (IGA severity \[3=moderate, 4=severe\] and PP NRS \[\>=7, \<7\]).|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control the overall type I error. Testing was performed sequentially in order the outcome measures were reported and continued when the test for the preceding outcome measure was statistically significant at two-sided 2.5% significance level. Participants with missing data were considered non-responders.||31.5|18.4|<0.0001
72330359|NCT03985943|144185945|OTHER||Strata-adjusted percentage difference|28.1|||<|0.0001|TWO_SIDED|97.5|22.0|34.3||Strata-adjusted p-values were calculated from Cochran-Mantel-Haenszel test adjusting randomized stratification variables (IGA severity \[3=moderate, 4=severe\] and PP NRS \[\>=7, \<7\]).|Cochran-Mantel-Haenszel||The estimates are from 50 complete datasets by MI-MAR assumption.|Nemolizumab 30 mg versus Placebo using multiple imputation (MI) with missing at random (MAR) assumption.||34.3|22.0|<0.0001
72330360|NCT03985943|144185946|OTHER||Strata-adjusted percentage difference|27.5|||<|0.0001|TWO_SIDED|97.5|19.4|35.7||Strata-adjusted p-values were calculated from Cochran-Mantel-Haenszel test adjusting randomized stratification variables (IGA severity \[3=moderate, 4=severe\].|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control the overall type I error. Testing was performed sequentially in order the outcome measures were reported and continued when the test for the preceding outcome measure was statistically significant at two-sided 2.5% significance level. Participants with missing data were considered non-responders.||35.7|19.4|<0.0001
72421711|NCT04858802|144354626|SUPERIORITY||Mean Difference (Final Values)|61.54|STANDARD_DEVIATION|460.18||0.375|TWO_SIDED|95.0|-76.7|199.8||Paired; the threshold for statistical significance was p = 0.05.|t-test, 2 sided||Difference = PROPEL Contour Sinus Implant mean FSOT volume minus balloon sinus dilation alone mean FSOT volume|Day 45||199.8|-76.7|0.375
72330361|NCT03985943|144185946|OTHER||Strata-adjusted percentage difference|32.1|||<|0.0001|TWO_SIDED|97.5|24.4|39.8||Strata-adjusted p-values were calculated from Cochran-Mantel-Haenszel test adjusting randomized stratification variables (IGA severity \[3=moderate, 4=severe\].|Cochran-Mantel-Haenszel||The estimates are from 50 complete datasets by MI-MAR assumption.|Nemolizumab 30 mg versus Placebo using MI-MAR assumption.||39.8|24.4|<0.0001
72330362|NCT03985943|144185947|OTHER||Strata-adjusted percentage difference|19.5|||<|0.0001|TWO_SIDED|97.5|13.7|25.2||Strata-adjusted p-values were calculated from Cochran-Mantel-Haenszel test adjusting randomized stratification variables (IGA severity \[3=moderate, 4=severe\] and PP NRS \[\>=7, \<7\]).|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control the overall type I error. Testing was performed sequentially in order the outcome measures were reported and continued when the test for the preceding outcome measure was statistically significant at two-sided 2.5% significance level.||25.2|13.7|<0.0001
72330363|NCT03985943|144185948|OTHER||Strata-adjusted percentage difference|20.3|||<|0.0001|TWO_SIDED|97.5|13.8|26.8||Strata-adjusted p-values were calculated from Cochran-Mantel-Haenszel test adjusting randomized stratification variables (IGA severity \[3=moderate, 4=severe\]).|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control the overall type I error. Testing was performed sequentially in order the outcome measures were reported and continued when the test for the preceding outcome measure was statistically significant at two-sided 2.5% significance level.||26.8|13.8|<0.0001
72330364|NCT03985943|144185949|OTHER||Strata-adjusted percentage difference|17.9|||<|0.0001|TWO_SIDED|97.5|11.3|24.5||Strata-adjusted p-values were calculated from Cochran-Mantel-Haenszel test adjusting randomized stratification variables (IGA severity \[3=moderate, 4=severe\] and PP NRS \[\>=7, \<7\]).|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control the overall type I error. Testing was performed sequentially in order the outcome measures were reported and continued when the test for the preceding outcome measure was statistically significant at two-sided 2.5% significance level.||24.5|11.3|<0.0001
72330365|NCT03985943|144185950|OTHER||Strata-adjusted percentage difference|19.7|||<|0.0001|TWO_SIDED|97.5|11.2|28.2||Strata-adjusted p-values were calculated from Cochran-Mantel-Haenszel test adjusting randomized stratification variables (IGA severity \[3=moderate, 4=severe\]).|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control the overall type I error. Testing was performed sequentially in order the outcome measures were reported and continued when the test for the preceding outcome measure was statistically significant at two-sided 2.5% significance level.||28.2|11.2|<0.0001
72330366|NCT03985943|144185951|OTHER||Strata-adjusted percentage difference|20.9|||<|0.0001|TWO_SIDED|97.5|15.8|26.0||Strata-adjusted p-values were calculated from Cochran-Mantel-Haenszel test adjusting randomized stratification variables (IGA severity \[3=moderate, 4=severe\] and PP NRS \[\>=7, \<7\]).|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control the overall type I error. Testing was performed sequentially in order the outcome measures were reported and continued when the test for the preceding outcome measure was statistically significant at two-sided 2.5% significance level.||26|15.8|<0.0001
72368849|NCT04603027|144247429|SUPERIORITY||||||||||||||||||There were not enough responders to model using GLMM or a Bayesian logistic model, and no treatment difference analysis was conducted.|||
72330367|NCT03985943|144185952|OTHER||Strata-adjusted percentage difference|21.2|||<|0.0001|TWO_SIDED|97.5|14.8|27.6||Strata-adjusted p-values were calculated from Cochran-Mantel-Haenszel test adjusting randomized stratification variables (IGA severity \[3=moderate, 4=severe\]).|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control the overall type I error. Testing was performed sequentially in order the outcome measures were reported and continued when the test for the preceding outcome measure was statistically significant at two-sided 2.5% significance level.||27.6|14.8|<0.0001
72330368|NCT03985943|144185953|OTHER||Strata-adjusted percentage difference|12.2|||<|0.0001|TWO_SIDED|97.5|8.2|16.3||Strata-adjusted p-values were calculated from Cochran-Mantel-Haenszel test adjusting randomized stratification variables (IGA severity \[3=moderate, 4=severe\] and PP NRS \[\>=7, \<7\]).|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control the overall type I error. Testing was performed sequentially in order the outcome measures were reported and continued when the test for the preceding outcome measure was statistically significant at two-sided 2.5% significance level.||16.3|8.2|<0.0001
72330369|NCT03985943|144185954|OTHER||Strata-adjusted percentage difference|9.7|||<|0.0001|TWO_SIDED|97.5|5.2|14.2||Strata-adjusted p-values were calculated from Cochran-Mantel-Haenszel test adjusting randomized stratification variables (IGA severity \[3=moderate, 4=severe\]).|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control the overall type I error. Testing was performed sequentially in order the outcome measures were reported and continued when the test for the preceding outcome measure was statistically significant at two-sided 2.5% significance level.||14.2|5.2|<0.0001
72330370|NCT03985943|144185955|OTHER||Strata-adjusted percentage difference|14.6|||<|0.0001|TWO_SIDED|97.5|10.6|18.7||Strata-adjusted p-values were calculated from Cochran-Mantel-Haenszel test adjusting randomized stratification variables (IGA severity \[3=moderate, 4=severe\] and PP NRS \[\>=7, \<7\]).|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control the overall type I error. Testing was performed sequentially in order the outcome measures were reported and continued when the test for the preceding outcome measure was statistically significant at two-sided 2.5% significance level.||18.7|10.6|<0.0001
72330371|NCT03985943|144185956|OTHER||Strata-adjusted percentage difference|16.9|||<|0.0001|TWO_SIDED|97.5|11.5|22.3||Strata-adjusted p-values were calculated from Cochran-Mantel-Haenszel test adjusting randomized stratification variables (IGA severity \[3=moderate, 4=severe\]).|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control the overall type I error. Testing was performed sequentially in order the outcome measures were reported and continued when the test for the preceding outcome measure was statistically significant at two-sided 2.5% significance level.||22.3|11.5|<0.0001
72330372|NCT03985943|144185957|OTHER||Strata-adjusted percentage difference|3.4||||0.0064|TWO_SIDED|97.5|1.1|5.8||Strata-adjusted p-values were calculated from Cochran-Mantel-Haenszel test adjusting randomized stratification variables (IGA severity \[3=moderate, 4=severe\] and PP NRS \[\>=7, \<7\]).|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control the overall type I error. Testing was performed sequentially in order the outcome measures were reported and continued when the test for the preceding outcome measure was statistically significant at two-sided 2.5% significance level.||5.8|1.1|0.0064
72330373|NCT03985943|144185958|OTHER||Strata-adjusted percentage difference|4.3||||0.0177|TWO_SIDED|97.5|0.9|7.7||Strata-adjusted p-values were calculated from Cochran-Mantel-Haenszel test adjusting randomized stratification variables (IGA severity \[3=moderate, 4=severe\]).|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control the overall type I error. Testing was performed sequentially in order the outcome measures were reported and continued when the test for preceding outcome measure was statistically significant at two-sided 2.5% significance level.||7.7|0.9|0.0177
72330374|NCT03587428|144185969|SUPERIORITY||Mean Difference (Final Values)|-0.3252||||0.1787|TWO_SIDED|95.0|-0.8101|0.1596|||ANCOVA|ANCOVA for treatment and period as fixed effects and subject as random effect and two baseline terms as covariates.|Difference is first named treatment minus second named treatment; a positive difference favors the first named treatment.|||0.1596|-0.8101|0.1787
72330375|NCT03587428|144185969|SUPERIORITY||Mean Difference (Final Values)|-0.7037||||0.0063|TWO_SIDED|95.0|-1.1886|-0.2187|||ANCOVA|ANCOVA for treatment and period as fixed effects and subject as random effect and two baseline terms as covariates.|Difference is first named treatment minus second named treatment; a positive difference favors the first named treatment.|||-0.2187|-1.1886|0.0063
72330376|NCT04004221|144185975|OTHER||||||<|0.0001|||||||Exact Binomial Test|1-sided p-value was based on binomial exact test of Tislelizumab versus historical rate of 0.1||||||< 0.0001
72330377|NCT02689206|144185988|OTHER||Mean Difference (Final Values)|0.57|||||TWO_SIDED|95.0|-0.31|1.45|||||Analysis using a Repeated Measures Model with terms included for baseline, treatment, time and treatment\*time. Model-adjusted treatment difference of dapro 10 mg arm from Placebo along with 95 percent CI are presented.|||1.45|-0.31|
72330378|NCT02689206|144185988|OTHER||Mean Difference (Final Values)|0.51|||||TWO_SIDED|95.0|-0.4|1.42|||||Analysis using a Repeated Measures Model with terms included for baseline, treatment, time and treatment\*time. Model-adjusted treatment difference of dapro 15 mg arm from Placebo along with 95 percent CI are presented.|||1.42|-0.40|
72330379|NCT02689206|144185988|OTHER||Mean Difference (Final Values)|1.47|||||TWO_SIDED|95.0|0.59|2.35|||||Analysis using a Repeated Measures Model with terms included for baseline, treatment, time and treatment\*time. Model-adjusted treatment difference of dapro 25 mg arm from Placebo along with 95 percent CI are presented.|||2.35|0.59|
72330380|NCT02689206|144185988|OTHER||Mean Difference (Final Values)|1.67|||||TWO_SIDED|95.0|0.77|2.57|||||Analysis using a Repeated Measures Model with terms included for baseline, treatment, time and treatment\*time. Model-adjusted treatment difference of dapro 30 mg arm from Placebo along with 95 percent CI are presented.|||2.57|0.77|
72330381|NCT00595881|144186034|SUPERIORITY_OR_OTHER||Difference in sensitivity|-1.7|||||TWO_SIDED|95.0|-3.4|0.0||"We calculated the differences between the sensitivities and specificities. The difference in sensitivity between the clinical exam alone vs clinical exam + ultrasound was -1.7% (-3.4%, 0%).~The difference in specificity was -2.8% (-9.7%, 4.1%)."|Mixed effects logistic regression|We used the bootstrap method to obtain valid confidence intervals and compare sensitivity and specificity for the 2 tests.|The clinical exam alone was compared to the clinical exam + ultrasound.|See sample size calculations already entered. Null hypothesis is that there is no difference in the sensitivity or specificity of clinical exam alone compared with clinical exam+ultrasound.||0|-3.4|
72330382|NCT00595881|144186034|SUPERIORITY_OR_OTHER||Difference in specificity|-2.8||||||95.0|-9.7|4.1||Statistical significance was defined as a CI surrounding the difference between groups not including 0.||as previously described for sensitivity||as previously described for sensitivity||4.1|-9.7|
72330383|NCT01939977|144186040|SUPERIORITY|||||||0.0083|||||||Chi-squared|||"Taking per protocol population, the percentage of patients with iPTH\> 110 pg / ml at 6 months post-transplant treated with Paricalcitol was statistically lower than in patients treated with Calcifediol"||||0.0083
72421712|NCT04858802|144354626|SUPERIORITY||Mean Difference (Final Values)|-51.98|STANDARD_DEVIATION|434.64||0.432|TWO_SIDED|95.0|-184.1|80.2||Paired; the threshold for statistical significance was p = 0.05.|t-test, 2 sided||Difference = PROPEL Contour Sinus Implant mean FSOT volume minus balloon sinus dilation alone mean FSOT volume|Day 180||80.2|-184.1|0.432
72330384|NCT01262560|144186065|SUPERIORITY_OR_OTHER|||||||0.92||||||Due to the skewed nature of the data, median was reported instead of mean.|Wilcoxon (Mann-Whitney)|Each arm had less than the designed sample size. Therefore the statistical power was reduced (76% instead of 80%).||Null hypothesis: Manuka honey in liquid form is/not effective at reducing esophagitis-related pain, measured by mean change score from 0 to 4 weeks. A 2-sample t-test for difference of means with alpha 0.05 after adjusting for multiple comparisons (1-sided with overall alpha 0.1 before the Bonferroni adjustment) and 80% statistical power for each hypothesis test requires 45 patients per arm to detect \>= 15% relative reduction (absolute difference of mean change score of 3.1; effect size=0.53).||||0.92
72330385|NCT01262560|144186065|SUPERIORITY_OR_OTHER|||||||0.93||||||Due to the skewed nature of the data, median was reported instead of mean.|Wilcoxon (Mann-Whitney)|Each arm had less than the designed sample size. Therefore the statistical power was reduced (76% instead of 80%)||Null hypothesis: Manuka honey in lozenge form is/not effective at reducing esophagitis-related pain, measured by mean change score from 0 to 4 weeks. A 2-sample t-test for difference of means with alpha 0.05 after adjusting for multiple comparisons (1-sided with overall alpha 0.1 before the Bonferroni adjustment) and 80% statistical power for each hypothesis test requires 45 patients per arm to detect \>= 15% relative reduction (absolute difference of mean change score of 3.1; effect size=0.53).||||0.93
72330386|NCT01262560|144186066|SUPERIORITY_OR_OTHER|||||||0.87|||||||Mixed Models Analysis|Explanatory variables are reported separately.||"A linear fixed effects model using maximum likelihood estimation was run with NRPS score (baseline, weekly during treatment and 12 weeks from the end of treatment) as the outcome of interest. Percentage of esophagus (V60\>=30% as reference level), opioid use (yes as reference level), time, and treatment arm were factors in the model. The results for each explanatory variable are reported separately. Treatment (Liquid Honey vs. Supportive Care) is reported here."||||0.87
72330387|NCT01262560|144186066|SUPERIORITY|||||||0.46|||||||Mixed Models Analysis|Each explanatory variable is reported separately.||"A linear fixed effects model using maximum likelihood estimation was run with NRPS score (baseline, weekly during treatment and 12 weeks from the end of treatment) as the outcome of interest. Percentage of esophagus (V60\>=30% as reference level), opioid use (yes as reference level), time, and treatment arm were factors in the model. The results for each explanatory variable are reported separately. Treatment (Lozenge Honey vs. Supportive Care) is reported here."||||0.46
72330388|NCT01262560|144186066|SUPERIORITY|||||||0.0023|||||||Mixed Models Analysis|Each explanatory variable is reported separately.||"A linear fixed effects model using maximum likelihood estimation was run with NRPS score (baseline, weekly during treatment and 12 weeks from the end of treatment) as the outcome of interest. Percentage of esophagus (V60\>=30% as reference level), opioid use (yes as reference level), time, and treatment arm were factors in the model. The results for each explanatory variable are reported separately. Percentage of esophagus is reported here."||||0.0023
72330389|NCT01262560|144186066|SUPERIORITY|||||||0.0025|||||||Mixed Models Analysis|Each explanatory variable is reported separately.||"A linear fixed effects model using maximum likelihood estimation was run with NRPS score (baseline, weekly during treatment and 12 weeks from the end of treatment) as the outcome of interest. Percentage of esophagus (V60\>=30% as reference level), opioid use (yes as reference level), time, and treatment arm were factors in the model. The results for each explanatory variable are reported separately. Opioid use is reported here."||||0.0025
72421713|NCT04858802|144354627|SUPERIORITY||Mean Difference (Final Values)|0.74|STANDARD_DEVIATION|2.13||0.023|TWO_SIDED|95.0|0.1|1.4||Paired; the threshold for statistical significance was p = 0.05.|t-test, 2 sided||Difference = PROPEL Contour Sinus Implant mean FSO minimum diameter minus balloon sinus dilation alone mean FSO minimum diameter|Day 45||1.4|0.1|0.023
72421714|NCT04858802|144354627|SUPERIORITY||Mean Difference (Final Values)|-0.16|STANDARD_DEVIATION|2.24||0.646|TWO_SIDED|95.0|-0.8|0.5||Paired; the threshold for statistical significance was p = 0.05.|t-test, 2 sided||Difference = PROPEL Contour Sinus Implant mean FSO minimum diameter minus balloon sinus dilation alone mean FSO minimum diameter|Day 180||0.5|-0.8|0.646
72421715|NCT02026232|144354628|SUPERIORITY|||||||0.05|||||||t-test, 2 sided|||||||0.05
72421716|NCT01529008|144354630|SUPERIORITY||Proportion treatment responder Differenc|-0.08||||0.539|TWO_SIDED|95.0|-0.35|0.18|||Fisher Exact||"Percentage of treatment responders in PREOB® group is 60.9% ((14/23)\*100), compared with 69.2% ((18/26)\*100) in Placebo.~Difference in percentage is -8.3 Difference in treatment responders proportion: PREOB® (0.609) - Placebo (0.692) = -0.08"|||0.18|-0.35|0.539
72421717|NCT05056870|144354637|SUPERIORITY|Superiority was declared if the upper limit of the 95% confidence interval of was below 0.00 logMAR.|Mean Difference|-0.097|STANDARD_ERROR_OF_MEAN|0.008|||TWO_SIDED|95.0|-0.113|-0.081|||Linear Mixed Model|Kenward and Roger method was used for denominator degrees of freedom.|Mean difference was calculated as Test - Control|||-0.081|-0.113|
72421718|NCT05056870|144354638|SUPERIORITY|Superiority was declared if the lower limit of the 95% confidence interval of was above 0.|Mean Difference|28.0|STANDARD_ERROR_OF_MEAN|2.69|||TWO_SIDED|95.0|22.6|33.3|||Linear Mixed Model|Kenward and Roger method was used for denominator degrees of freedom.|Mean difference was calculated as Test - Control|||33.3|22.6|
72421719|NCT05056870|144354639|NON_INFERIORITY|Non-Inferiority was declared if the upper limit of the 95% confidence interval of was below 0.05 logMAR.|Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.0061|||TWO_SIDED|95.0|-0.032|-0.008|||Linear Mixed Model|Kenward and Roger method was used for denominator degrees of freedom.|Mean difference was calculated as Test - Control|||-0.008|-0.032|
72421720|NCT05056870|144354640|SUPERIORITY|Superiority was declared if the lower limit of the 95% confidence interval of was above 1.|Mean Ratio|2.98|||||TWO_SIDED|95.0|1.73|5.11|||Generalized Linear Mixed Model||Mean Ratio was calculated as Test over Control|||5.11|1.73|
72330390|NCT01262560|144186066|SUPERIORITY||||||<|0.0001||||||Each explanatory variable is reported separately.|Mixed Models Analysis|||"A linear fixed effects model using maximum likelihood estimation was run with NRPS score (baseline, weekly during treatment and 12 weeks from the end of treatment) as the outcome of interest. Percentage of esophagus (V60\>=30% as reference level), opioid use (yes as reference level), time, and treatment arm were factors in the model. The results for each explanatory variable are reported separately. Time is reported here."||||<0.0001
72421721|NCT02466646|144354657|OTHER||Mean Difference (Net)|0.3|||<|0.01|TWO_SIDED|||||The threshold for statistical significance was p=0.05|Kruskal-Wallis|||||||<0.01
72421722|NCT02466646|144354658|OTHER||Mean Difference (Net)|2.0|||>|0.05|TWO_SIDED|||||The threshold for statistical significance was P=0.05|Kruskal-Wallis|||||||>0.05
72421723|NCT02466646|144354659|OTHER|||||||0.229||||||Threshold for statistical significance is p=0.05.|Kruskal-Wallis|||||||0.229
72421724|NCT02466646|144354660|OTHER|||||||0.28||||||Threshold for statistical significance is p=0.05.|Kruskal-Wallis|||||||0.280
72421725|NCT02466646|144354661|OTHER|||||||0.712|||||||Kruskal-Wallis|Threshold for statistical significance is p=0.05.||||||0.712
72421726|NCT02466646|144354662|OTHER|||||||0.674||||||The threshold for statistical significance is p=0.05.|Kruskal-Wallis|||||||0.674
72421727|NCT02466646|144354663|OTHER||Mean Difference (Net)|30.0||||0.006|TWO_SIDED|||||The threshold for statistical significance was p=0.05|Kruskal-Wallis|||||||0.006
72421728|NCT02466646|144354664|OTHER||Mean Difference (Net)|0.5||||0.373|TWO_SIDED||||||Kruskal-Wallis|||||||0.373
72421729|NCT02466646|144354665|OTHER||Mean Difference (Net)|0.6||||0.528|TWO_SIDED||||||Kruskal-Wallis|||||||0.528
72421730|NCT02466646|144354666|OTHER||Mean Difference (Net)|1.0||||0.208|TWO_SIDED||||||Kruskal-Wallis|||||||0.208
72421731|NCT02466646|144354667|OTHER|||||||0.051|||||||Kruskal-Wallis|||||||0.051
72421732|NCT02466646|144354668|OTHER|||||||0.647||||||The threshold for statistical significance is p=0.05.|Kruskal-Wallis|||||||0.647
72421733|NCT03261271|144354669|SUPERIORITY|||||||0.6489||||||P value less than 0.05 was considered statistically significant.|Mixed Models Analysis|||||||0.6489
72421734|NCT03261271|144354670|SUPERIORITY|||||||0.0323|||||||Mixed Models Analysis|||||||0.0323
72421735|NCT03261271|144354671|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||||||<0.0001
72330391|NCT01262560|144186067|SUPERIORITY_OR_OTHER|||||||0.7|||||||Mixed Models Analysis|Explanatory variables are reported separately.||"A linear fixed effects model using maximum likelihood estimation was run with dysphagia score (baseline, weekly during treatment and 12 weeks from the end of treatment) as the outcome of interest. Percentage of esophagus (V60\>=30% as reference level), opioid use (yes as reference level), time, and treatment arm were factors in the model. Treatment (Liquid Honey vs. Supportive Care) is reported here."||||0.70
72421736|NCT03261271|144354672|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||||||<0.0001
72330392|NCT01262560|144186067|SUPERIORITY_OR_OTHER|||||||0.71|||||||Mixed Models Analysis|Explanatory variables are reported separately.||"A linear fixed effects model using maximum likelihood estimation was run with dysphagia score (baseline, weekly during treatment and 12 weeks from the end of treatment) as the outcome of interest. Percentage of esophagus (V60\>=30% as reference level), opioid use (yes as reference level), time, and treatment arm were factors in the model. The results for each explanatory variable are reported separately. Treatment (Lozenge Honey vs. Supportive Care) is reported here."||||0.71
72421737|NCT03261271|144354673|SUPERIORITY|||||||0.09|||||||Mixed Models Analysis|||Difference between groups from Baseline to Study End.||||0.09
72421738|NCT03261271|144354673|SUPERIORITY|||||||0.04|||||||Mixed Models Analysis|||Difference between groups from baseline to pre-surgery.||||0.04
72421739|NCT01114204|144354674|NON_INFERIORITY|The 95% confidence interval (CI) was calculated using the large sample assumption. The pre-defined non-inferiority margin for testing the difference between treatment groups was -15%.|Treatment Difference|2.58||||0.2833|TWO_SIDED|95.0|-3.89|9.06|||Cochran-Mantel-Haenszel|The p-value is the result of the Cochran-Mantel-Haenszel test, adjusted for Baseline hemoglobin level and underlying condition.|The treatment difference (ferumoxytol - iron sucrose) was expressed as a percentage.|"Participants who achieved a ≥2.0 g/dL increase in hemoglobin from Baseline up to Week 5 were analyzed. Statistical comparison was performed for data up to Week 5 only.~Baseline was defined as the Day 1 value (prior to injection of study drug). The screening or most recent value prior to Day 1 was used for any participant with missing Day 1 information."||9.06|-3.89|0.2833
72330393|NCT01262560|144186067|SUPERIORITY|||||||0.0002|||||||Mixed Models Analysis|Each explanatory variable is reported separately.||"A linear fixed effects model using maximum likelihood estimation was run with dysphagia score (baseline, weekly during treatment and 12 weeks from the end of treatment) as the outcome of interest. Percentage of esophagus (V60\>=30% as reference level), opioid use (yes as reference level), time, and treatment arm were factors in the model. The results for each explanatory variable are reported separately. Percentage of esophagus is reported here."||||0.0002
72330394|NCT01262560|144186067|SUPERIORITY|||||||0.0051|||||||Mixed Models Analysis|Each explanatory variable is reported separately.||"A linear fixed effects model using maximum likelihood estimation was run with dysphagia score (baseline, weekly during treatment and 12 weeks from the end of treatment) as the outcome of interest. Percentage of esophagus (V60\>=30% as reference level), opioid use (yes as reference level), time, and treatment arm were factors in the model. The results for each explanatory variable are reported separately. Opioid use is reported here."||||0.0051
72330395|NCT01262560|144186067|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|Each explanatory variable is reported separately.||"A linear fixed effects model using maximum likelihood estimation was run with dysphagia score (baseline, weekly during treatment and 12 weeks from the end of treatment) as the outcome of interest. Percentage of esophagus (V60\>=30% as reference level), opioid use (yes as reference level), time, and treatment arm were factors in the model. The results for each explanatory variable are reported separately. Time is reported here."||||<0.0001
72421740|NCT00246337|144354697|SUPERIORITY_OR_OTHER|||||||0.015||95.0||||0.05 is the pre-specified significance level.|generalized linear model|The p-value is based on the average response of the MK0974 200mg, 400mg, and 600mg groups vs. placebo.||Only the MK0974 300mg, 400mg, and 600mg groups are included in the comparison with placebo based on the protocol-specified test statistics selection and the fact that all lower doses were discontinued after the interim analysis. Overall power =85%||||0.015
72330396|NCT01262560|144186068|SUPERIORITY_OR_OTHER|||||||0.086|||||||Mixed Models Analysis|Explanatory variables are reported separately.||"A linear fixed effects model using maximum likelihood estimation was run with EORTC global health status (baseline, weekly during treatment and 12 weeks from the end of treatment) as the outcome of interest. Percentage of esophagus (V60\>=30% as reference level), opioid use (yes as reference level), time, and treatment arm were factors in the model. The results for each explanatory variable are reported separately. Treatment (Liquid Honey vs. Supportive Care) is reported here."||||0.086
72368850|NCT04603027|144247429|SUPERIORITY||||||||||||||||||There were not enough responders to model using GLMM or a Bayesian logistic model, and no treatment difference analysis was conducted.|||
72330397|NCT01262560|144186068|SUPERIORITY_OR_OTHER|||||||0.2|||||||Mixed Models Analysis|Each explanatory variable is reported separately.||"A linear fixed effects model using maximum likelihood estimation was run with EORTC global health status (baseline, weekly during treatment and 12 weeks from the end of treatment) as the outcome of interest. Percentage of esophagus (V60\>=30% as reference level), opioid use (yes as reference level), time, and treatment arm were factors in the model. The results for each explanatory variable are reported separately. Treatment (Lozenge Honey vs. Supportive Care) is reported here."||||0.20
72330398|NCT01262560|144186068|SUPERIORITY|||||||0.44|||||||Mixed Models Analysis|Each explanatory variable is reported separately.||"A linear fixed effects model using maximum likelihood estimation was run with EORTC global health status (baseline, weekly during treatment and 12 weeks from the end of treatment) as the outcome of interest. Percentage of esophagus (V60\>=30% as reference level), opioid use (yes as reference level), time, and treatment arm were factors in the model. The results for each explanatory variable are reported separately. Percentage of esophagus is reported here."||||0.44
72330399|NCT01262560|144186068|SUPERIORITY|||||||0.0066|||||||Mixed Models Analysis|Each explanatory variable is reported separately.||"A linear fixed effects model using maximum likelihood estimation was run with EORTC global health status (baseline, weekly during treatment and 12 weeks from the end of treatment) as the outcome of interest. Percentage of esophagus (V60\>=30% as reference level), opioid use (yes as reference level), time, and treatment arm were factors in the model. The results for each explanatory variable are reported separately. Opioid use is reported here."||||0.0066
72330400|NCT01262560|144186068|SUPERIORITY|||||||0.36|||||||Mixed Models Analysis|Each explanatory variable is reported separately.||"A linear fixed effects model using maximum likelihood estimation was run with EORTC global health status (baseline, weekly during treatment and 12 weeks from the end of treatment) as the outcome of interest. Percentage of esophagus (V60\>=30% as reference level), opioid use (yes as reference level), time, and treatment arm were factors in the model. The results for each explanatory variable are reported separately. Time is reported here."||||0.36
72330401|NCT01262560|144186068|SUPERIORITY_OR_OTHER|||||||0.94|||||||Mixed Models Analysis|Explanatory variables are reported separately.||"A linear fixed effects model using maximum likelihood estimation was run with EORTC pain score (baseline, weekly during treatment and 12 weeks from the end of treatment) as the outcome of interest. Percentage of esophagus (V60\>=30% as reference level), opioid use (yes as reference level), time, and treatment arm were factors in the model. The results for each explanatory variable are reported separately. Treatment (Liquid Honey vs. Supportive Care) is reported here."||||0.94
72330402|NCT01262560|144186068|SUPERIORITY_OR_OTHER|||||||0.58|||||||Mixed Models Analysis|Each explanatory variable is reported separately.||"A linear fixed effects model using maximum likelihood estimation was run with EORTC pain score (baseline, weekly during treatment and 12 weeks from the end of treatment) as the outcome of interest. Percentage of esophagus (V60\>=30% as reference level), opioid use (yes as reference level), time, and treatment arm were factors in the model. The results for each explanatory variable are reported separately. Treatment (Lozenge Honey vs. Supportive Care) is reported here."||||0.58
72330403|NCT01262560|144186068|SUPERIORITY|||||||0.28|||||||Mixed Models Analysis|Each explanatory variable is reported separately.||"A linear fixed effects model using maximum likelihood estimation was run with EORTC pain score (baseline, weekly during treatment and 12 weeks from the end of treatment) as the outcome of interest. Percentage of esophagus (V60\>=30% as reference level), opioid use (yes as reference level), time, and treatment arm were factors in the model. The results for each explanatory variable are reported separately. Percentage of esophagus is reported here."||||0.28
72330404|NCT01262560|144186068|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|Each exploratory variable is reported separately.||"A linear fixed effects model using maximum likelihood estimation was run with EORTC pain score (baseline, weekly during treatment and 12 weeks from the end of treatment) as the outcome of interest. Percentage of esophagus (V60\>=30% as reference level), opioid use (yes as reference level), time, and treatment arm were factors in the model. The results for each explanatory variable are reported separately. Opioid use is reported here."||||<0.0001
72330405|NCT01262560|144186068|SUPERIORITY|||||||0.28|||||||Mixed Models Analysis|Each explanatory variable is reported separately.||"A linear fixed effects model using maximum likelihood estimation was run with EORTC pain score (baseline, weekly during treatment and 12 weeks from the end of treatment) as the outcome of interest. Percentage of esophagus (V60\>=30% as reference level), opioid use (yes as reference level), time, and treatment arm were factors in the model. The results for each explanatory variable are reported separately. Time is reported here."||||0.28
72330406|NCT01262560|144186069|SUPERIORITY_OR_OTHER|||||||0.06||||||Significance level = 0.05|Fisher Exact|||||||0.06
72330407|NCT01262560|144186069|SUPERIORITY_OR_OTHER|||||||0.31||||||Significance level = 0.05|Fisher Exact|||||||0.31
72330408|NCT01262560|144186070|SUPERIORITY_OR_OTHER|||||||0.53||||||significance level = 0.05|t-test, 2 sided|||||||0.53
72330409|NCT01262560|144186070|SUPERIORITY_OR_OTHER|||||||0.88||||||significance level = 0.05|t-test, 2 sided|||||||0.88
72330410|NCT01262560|144186071|SUPERIORITY_OR_OTHER|||||||0.2|||||||t-test, 2 sided|||||||0.20
72330411|NCT01262560|144186071|SUPERIORITY_OR_OTHER|||||||0.28|||||||t-test, 2 sided|||||||0.28
72368851|NCT04603027|144247430|SUPERIORITY||Posterior Mean difference|-9.08|||||TWO_SIDED|95.0|-30.22|12.4||||||||12.40|-30.22|
72368852|NCT04603027|144247430|SUPERIORITY||Posterior Mean difference|2.99|||||TWO_SIDED|95.0|-23.41|18.15||||||||18.15|-23.41|
72368853|NCT04603027|144247430|SUPERIORITY||Posterior Mean difference|-17.1|||||TWO_SIDED|95.0|-38.29|3.25||||||||3.25|-38.29|
72368854|NCT04603027|144247431|SUPERIORITY||Posterior Mean difference|-2.66|||||TWO_SIDED|95.0|-6.79|1.52||||||||1.52|-6.79|
72368855|NCT04603027|144247431|SUPERIORITY||Posterior Mean difference|-0.83|||||TWO_SIDED|95.0|-4.7|3.16||||||||3.16|-4.70|
72368856|NCT04603027|144247431|SUPERIORITY||Posterior Mean difference|-3.53|||||TWO_SIDED|95.0|-7.49|0.63||||||||0.63|-7.49|
72368857|NCT04603027|144247432|SUPERIORITY||Posterior Mean difference|-9.08|||||TWO_SIDED|95.0|-30.22|12.4||||||||12.40|-30.22|
72368858|NCT04603027|144247432|SUPERIORITY||Posterior Mean difference|-2.99|||||TWO_SIDED|95.0|-23.41|18.15||||||||18.15|-23.41|
72368859|NCT04603027|144247432|SUPERIORITY||Posterior Mean difference|-17.1|||||TWO_SIDED|95.0|-38.29|3.25||||||||3.25|-38.29|
72368860|NCT04603027|144247433|SUPERIORITY||Posterior Mean difference|-2.66|||||TWO_SIDED|95.0|-6.79|1.52||||||||1.52|-6.79|
72368861|NCT04603027|144247433|SUPERIORITY||Posterior Mean difference|-0.83|||||TWO_SIDED|95.0|-4.7|3.16||||||||3.16|-4.70|
72368862|NCT04603027|144247433|SUPERIORITY||Posterior Mean difference|-3.53|||||TWO_SIDED|95.0|-7.49|0.63||||||||0.63|-7.49|
72368863|NCT04603027|144247434|SUPERIORITY||Posterior Mean difference|2.99|||||TWO_SIDED|95.0|-19.99|28.84||||||||28.84|-19.99|
72368864|NCT04603027|144247434|SUPERIORITY||Posterior Mean difference|-2.49|||||TWO_SIDED|95.0|-26.47|21.55||||||||21.55|-26.47|
72368865|NCT04603027|144247434|SUPERIORITY||Posterior Mean difference|13.36|||||TWO_SIDED|95.0|-12.03|36.92||||||||36.92|-12.03|
72368866|NCT04603027|144247435|SUPERIORITY||Posterior Mean difference|0.62|||||TWO_SIDED|95.0|-1.1|2.3||||||||2.30|-1.10|
72368867|NCT04603027|144247435|SUPERIORITY||Posterior Mean difference|-0.21|||||TWO_SIDED|95.0|-1.96|1.37||||||||1.37|-1.96|
72368868|NCT04603027|144247435|SUPERIORITY||Posterior Mean difference|-0.08|||||TWO_SIDED|95.0|-1.73|1.75||||||||1.75|-1.73|
72368869|NCT04603027|144247436|SUPERIORITY||Posterior Mean difference|13.71|||||TWO_SIDED|95.0|-50.62|73.35||||||||73.35|-50.62|
72368870|NCT04603027|144247436|SUPERIORITY||Posterior Mean difference|73.69|||||TWO_SIDED|95.0|21.69|126.92||||||||126.92|21.69|
72368871|NCT04603027|144247436|SUPERIORITY||Posterior Mean difference|8.41|||||TWO_SIDED|95.0|-44.58|56.81||||||||56.81|-44.58|
72368872|NCT04603027|144247437|SUPERIORITY||Posterior Mean difference|0.62|||||TWO_SIDED|95.0|-1.1|2.3||||||||2.30|-1.10|
72368873|NCT04603027|144247437|SUPERIORITY||Posterior Mean difference|-0.21|||||TWO_SIDED|95.0|-1.96|1.37||||||||1.37|-1.96|
72330412|NCT01262560|144186074|SUPERIORITY_OR_OTHER|||||||0.39|||||||Wilcoxon (Mann-Whitney)|Because data was not normally distributed, this test was used instead of the t-test.||Each experimental arm was compared to the control arm (i.e. 2 comparisons) using two-sample t-tests. Forty-five patients with data in each arm, provides 80% power to detect an effect size (in standard deviation units) of 0.60 and 90% power to detect an effect size of 0.69 using a two-sided T-test with a Bonferroni adjusted significance level of 0.05 for each comparison (overall alpha 0.10). Due to the lack of prior data on the PRO-CTCAE, moderate effect sizes were used.||||0.39
72330413|NCT01262560|144186074|SUPERIORITY_OR_OTHER|||||||0.69|||||||Wilcoxon (Mann-Whitney)|Because data was not normally distributed, this test was used instead of the t-test.||Each experimental arm was compared to the control arm (i.e. 2 comparisons) using two-sample t-tests. Forty-five patients with data in each arm, provides 80% power to detect an effect size (in standard deviation units) of 0.60 and 90% power to detect an effect size of 0.69 using a two-sided T-test with a Bonferroni adjusted significance level of 0.05 for each comparison (overall alpha 0.10). Due to the lack of prior data on the PRO-CTCAE, moderate effect sizes were used.||||0.69
72368874|NCT04603027|144247437|SUPERIORITY||Posterior Mean difference|-0.08|||||TWO_SIDED|95.0|-1.73|1.75||||||||1.75|-1.73|
72330414|NCT00673231|144186093|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.45|STANDARD_ERROR_OF_MEAN|0.0726|<|0.0001|TWO_SIDED|95.0|-0.59|-0.31||significant at alpha=0.019 (2-sided) applying Dunnett's adjustment. A hierarchical closed testing procedure was used to control the Type I error rate across the primary and key secondary endpoints.|ANCOVA|with treatment group (all treatment groups included) and stratum (other oral anti-diabetic med use) as effect and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0 (with alpha = 0.019 applying Dunnett's adjustment, two-sided)||-0.31|-0.59|<0.0001
72330415|NCT00673231|144186093|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.52|STANDARD_ERROR_OF_MEAN|0.0718|<|0.0001|TWO_SIDED|95.0|-0.66|-0.38||significant at alpha=0.019 (2-sided) applying Dunnett's adjustment. A hierarchical closed testing procedure was used to control the Type I error rate across the primary and key secondary endpoints.|ANCOVA|with treatment group (all treatment groups included) and stratum (other oral anti-diabetic med use) as effect and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0 (with alpha = 0.019 applying Dunnett's adjustment, two-sided)||-0.38|-0.66|<0.0001
72330416|NCT00673231|144186093|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.0733|<|0.0001|TWO_SIDED|95.0|-0.74|-0.45||significant at alpha=0.019 (2-sided) applying Dunnett's adjustment. A hierarchical closed testing procedure was used to control the Type I error rate across the primary and key secondary endpoints.|ANCOVA|with treatment group (all treatment groups included) and stratum (other oral anti-diabetic med use) as effect and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0 (with alpha = 0.019 applying Dunnett's adjustment, two-sided)||-0.45|-0.74|<0.0001
72330417|NCT00673231|144186094|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0|STANDARD_ERROR_OF_MEAN|0.256||0.0001|TWO_SIDED|95.0|-1.5|-0.49||significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure within treatment group.|ANCOVA|with treatment group (all treatment groups included) and stratum (other oral anti-diabetic med use) as effect and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0||-0.49|-1.50|0.0001
72330418|NCT00673231|144186094|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0|STANDARD_ERROR_OF_MEAN|0.2523|<|0.0001|TWO_SIDED|95.0|-1.5|-0.5||significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure within treatment group.|ANCOVA|||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0||-0.50|-1.50|<0.0001
72330419|NCT00673231|144186094|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.68|STANDARD_ERROR_OF_MEAN|0.2578|<|0.0001|TWO_SIDED|95.0|-2.19|-1.18||significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure within treatment group.|ANCOVA|with treatment group (all treatment groups included) and stratum (other oral anti-diabetic med use) as effect and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0||-1.18|-2.19|<0.0001
72330420|NCT00673231|144186095|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.87|STANDARD_ERROR_OF_MEAN|1.3195|<|0.0001|TWO_SIDED|95.0|-9.46|-4.28||significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure within treatment group.|ANCOVA|with treatment group (all treatment groups included) and stratum (other oral anti-diabetic med use) as effect and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0||-4.28|-9.46|<0.0001
72330421|NCT00673231|144186095|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.69|STANDARD_ERROR_OF_MEAN|1.3045|<|0.0001|TWO_SIDED|95.0|-8.25|-3.13||significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure within treatment group.|ANCOVA|with treatment group (all treatment groups included) and stratum (other oral anti-diabetic med use) as effect and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0||-3.13|-8.25|<0.0001
72330422|NCT00673231|144186095|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.23|STANDARD_ERROR_OF_MEAN|1.3286|<|0.0001|TWO_SIDED|95.0|-8.84|-3.63||significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure within treatment group.|ANCOVA|with treatment group (all treatment groups included) and stratum (other oral anti-diabetic med use) as effect and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0||-3.63|-8.84|<0.0001
72330423|NCT00673231|144186096|SUPERIORITY_OR_OTHER||Risk Difference (RD)|7.2|STANDARD_ERROR_OF_MEAN|3.536||0.0427|TWO_SIDED|95.0|0.2|14.1||significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure within treatment group.|Regression, Logistic|Methodology of Zhang, Tsiatis \& Davidian and Davidian, Tsiatis, Zhang \& Lu, adjustment for stratum (other oral anti-diab med use) and baseline value.||H0: proportion(treat) minus proportion(placebo) = 0 versus the alternative HA: proportion(treat) minus proportion(placebo) =/= 0||14.1|0.2|0.0427
72330424|NCT00673231|144186096|SUPERIORITY_OR_OTHER||Risk Difference (RD)|5.8|STANDARD_ERROR_OF_MEAN|3.434||0.0903|TWO_SIDED|95.0|-0.9|12.5||not significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure within treatment group.|Regression, Logistic|Methodology of Zhang, Tsiatis \& Davidian and Davidian, Tsiatis, Zhang \& Lu, adjustment for stratum (other oral anti-diab med use) and baseline value.||H0: proportion(treat) minus proportion(placebo) = 0 versus the alternative HA: proportion(treat) minus proportion(placebo) =/= 0||12.5|-0.9|0.0903
72421741|NCT00246337|144354698|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||0.05 is the pre-specified significance level.|generalized linear model|The p-value is based on the average response of the MK0974 200mg, 400mg, and 600mg groups vs. placebo.||Only the MK0974 300mg, 400mg, and 600mg groups are included in the comparison with placebo based on the protocol-specified test statistics selection and the fact that all lower doses were discontinued after the interim analysis.||||<0.001
72330425|NCT00673231|144186096|SUPERIORITY_OR_OTHER||Risk Difference (RD)|8.7|STANDARD_ERROR_OF_MEAN|3.634||0.0166|TWO_SIDED|95.0|1.6|15.8||significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure within treatment group.|Regression, Logistic|Methodology of Zhang, Tsiatis \& Davidian and Davidian, Tsiatis, Zhang \& Lu, adjustment for stratum (other oral anti-diab med use) and baseline value.||H0: proportion(treat) minus proportion(placebo) = 0 versus the alternative HA: proportion(treat) minus proportion(placebo) =/= 0||15.8|1.6|0.0166
72330426|NCT00673231|144186097|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.8|STANDARD_ERROR_OF_MEAN|4.684||0.0008|TWO_SIDED|95.0|-25.0|-6.6||significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure within treatment group.|ANCOVA|with treatment group (all treatment groups included) and stratum (other oral anti-diabetic med use) as effect and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0||-6.6|-25.0|0.0008
72330427|NCT00673231|144186097|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-22.1|STANDARD_ERROR_OF_MEAN|4.616|||TWO_SIDED|95.0|-31.2|-13.1||Not significant. Hierarchical closed testing procedure within treatment group stopped at previous endpoint.|ANCOVA|with treatment group (all treatment groups included) and stratum (other oral anti-diabetic med use) as effect and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0||-13.1|-31.2|
72330428|NCT00673231|144186097|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-25.0|STANDARD_ERROR_OF_MEAN|4.718|<|0.0001|TWO_SIDED|95.0|-34.3|-15.8||significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure within treatment group.|ANCOVA|with treatment group (all treatment groups included) and stratum (other oral anti-diabetic med use) as effect and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0||-15.8|-34.3|<0.0001
72330429|NCT02907216|144186118|NON_INFERIORITY|Criteria for non-inferiority: The Lower Limit (LL) of the standardised asymptotic 95% Confidence Interval (CI) on the difference (Co-administration Group minus Staggered Group) in the percentage of subjects with seroprotective concentrations ≥ 0.1 IU/mL for anti-D antibodies should be ≥ -10%.|Difference-Seroprotective concentration|0.0|||||TWO_SIDED|95.0|-2.66|2.74|||||The 2-sided asymptotic standardised 95% CIs for the difference between groups in terms of percentage of subjects with antibody concentration ≥ to the pre-defined cut-off.|Difference between Co-administration Group minus Staggered Group in terms of percentage of subjects with anti-D antibody concentration ≥ 0.1 IU/mL.||2.74|-2.66|
72421742|NCT00246337|144354699|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||0.05 is the pre-specified significance level.|generalized linear model|||Only the MK0974 300mg, 400mg, and 600mg groups are included in the comparison with placebo based on the protocol-specified test statistics selection and the fact that all lower doses were discontinued after the interim analysis.||||<0.001
72421743|NCT00246337|144354700|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||0.05 is the pre-specified significance level.|generalized linear model|The p-value is based on the average response of the MK0974 200mg, 400mg, and 600mg groups vs. placebo.||Only the MK0974 300mg, 400mg, and 600mg groups are included in the comparison with placebo based on the protocol-specified test statistics selection and the fact that all lower doses were discontinued after the interim analysis.||||<0.001
72421744|NCT00141739|144354711|SUPERIORITY_OR_OTHER|||||||0.001|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test||||||0.001
72421745|NCT04074590|144354733|OTHER|A Bayesian analysis of clinical remission rate (based on total Mayo score) with binomial distribution, was modelled with baseline total Mayo score and treatment group as explanatory variables, to compare the remission rates between LYS006 and placebo groups.|Posterior estimate treatment difference|-3.29||||0.314|TWO_SIDED|90.0|-18.02|13.23||Posterior probability that clinical remission rate is better than placebo: Prob (diff\>0)|Bayesian analysis||90% credible intervals are reported on the treatment difference|||13.23|-18.02|0.314
72421746|NCT04074590|144354733|OTHER|A Bayesian analysis of clinical remission rate (based on total Mayo score) with binomial distribution, was modelled with baseline total Mayo score and treatment group as explanatory variables, to compare the remission rates between LYS006 and placebo groups.|Posterior estimate treatment difference|-3.29||||0.037|TWO_SIDED|90.0|-18.02|13.23||Posterior probability that clinical remission rate \>15% over placebo: Prob (diff\>0.15)|Bayesian analysis||90% credible intervals are reported on the treatment difference|||13.23|-18.02|0.037
72421747|NCT00691132|144354736|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.7||||0.023|TWO_SIDED|95.0|-13.8|-1.2|||Mixed Models Analysis|||% difference between Placebo and PEITC periods in the ratio of \[pyridine-D4\]Hydroxy acid : \[pyridine-D4\] total NNAL||-1.2|-13.8|0.023
72421748|NCT00691132|144354737|SUPERIORITY_OR_OTHER|||||||0.005|TWO_SIDED||||||ANOVA|||Total ITC||||0.005
72421749|NCT00691132|144354739|SUPERIORITY_OR_OTHER|||||||0.017|TWO_SIDED||||||ANOVA|||Total ITC||||0.017
72421750|NCT00691132|144354740|SUPERIORITY_OR_OTHER|||||||0.039|||||||Mixed Models Analysis|||||||0.039
72421751|NCT00691132|144354740|SUPERIORITY_OR_OTHER|||||||0.623|||||||Mixed Models Analysis|||||||0.623
72421752|NCT00691132|144354740|SUPERIORITY_OR_OTHER|||||||0.045|||||||Mixed Models Analysis|||||||0.045
72421753|NCT02037438|144354773|SUPERIORITY_OR_OTHER||Provider-Effect Adjusted Difference|0.03|STANDARD_ERROR_OF_MEAN|0.075||0.687|TWO_SIDED||||||see Comments|Finite-Mixture Models with Fixed Effects for Providers||||||0.687
72421754|NCT02037438|144354774|SUPERIORITY_OR_OTHER||Provider-Effect Adjusted Difference|-0.007|STANDARD_ERROR_OF_MEAN|0.539||0.989|TWO_SIDED||||||see Comments|Heteroscedasticity-Consistent Linear Regression with Fixed Effects for Providers and Baseline Covariate||||||0.989
72421755|NCT02037438|144354775|SUPERIORITY_OR_OTHER||Provider-Effect Adjusted Difference|0.114|STANDARD_ERROR_OF_MEAN|0.141||0.417|TWO_SIDED||||||see Comments|Finite-Mixture Models with Fixed Effects for Providers||||||0.417
72421756|NCT02037438|144354776|SUPERIORITY_OR_OTHER||Provider-Effect Adjusted Difference|0.057|STANDARD_ERROR_OF_MEAN|0.078||0.468|TWO_SIDED||||||see Comments|Finite-Mixture Models with Fixed Effects for Providers||||||0.468
72421757|NCT02037438|144354777|SUPERIORITY_OR_OTHER||Provider-Effect Adjusted Difference|0.177|STANDARD_ERROR_OF_MEAN|0.061||0.003|TWO_SIDED||||||see Comments|Finite-Mixture Models with Fixed Effects for Providers||||||0.003
72421758|NCT02255032|144354778|SUPERIORITY||Mean Difference (Final Values)|-164.44|STANDARD_DEVIATION|173.148||0.0017|TWO_SIDED|95.0|-256.7|-72.2||The primary analysis of the primary efficacy endpoint was the comparison between the Baseline and Month 2 values for the 4 mg treatment group. No adjustments for multiplicity were necessary.|Paired t-test, two-sided|||"A paired t-test was used to assess the statistical significance of the change between Baseline and Month 2.~A sample size of 16 subjects would have 80% power to detect a difference of 75, assuming a standard deviation of 100, using a paired t-test with a 0.050 two-sided significance level."||-72.2|-256.7|0.0017
72421759|NCT05375955|144354779|OTHER||Risk Difference (RD)|12.4||||0.0711|TWO_SIDED|95.0|-4.1|29.4|||Chan and Zhang (1999) method|||||29.4|-4.1|0.0711
72421760|NCT05375955|144354779|OTHER||Risk Difference (RD)|10.1||||0.129|TWO_SIDED|95.0|-6.1|26.8|||Chan and Zhang (1999) method|||||26.8|-6.1|0.1290
72421761|NCT05375955|144354780|OTHER||Risk Difference (RD)|6.3||||0.2712|TWO_SIDED|95.0|-10.8|24.3|||Chan and Zhang (1999) method|||||24.3|-10.8|0.2712
72330430|NCT02907216|144186118|NON_INFERIORITY|Criteria for non-inferiority: The LL of the standardised asymptotic 95% CI on the difference (Co-administration Group minus Staggered Group) in the percentage of subjects with seroprotective concentrations ≥ 0.1 IU/mL for anti-T antibodies should be ≥ -10%.|Difference-Seroprotective concentration|-0.69|||||TWO_SIDED|95.0|-4.39|2.71|||||The 2-sided asymptotic standardised 95% CIs for the difference between groups in terms of percentage of subjects with antibody concentration ≥ to the pre-defined cut-off.|Difference between Co-administration Group minus Staggered Group in terms of percentage of subjects with anti-T antibody concentration ≥ 0.1 IU/mL.||2.71|-4.39|
72330431|NCT02907216|144186119|NON_INFERIORITY|Criteria for non-inferiority: The LL of the standardised asymptotic 95% CI on the difference (Co-administration Group minus Staggered Group) in the percentage of subjects with seroprotective concentrations ≥ 10 IU/mL for anti-PT antibodies should be ≥ -10%.|Difference-Seroprotective concentration|2.99|||||TWO_SIDED|95.0|-2.7|9.12|||||The 2-sided asymptotic standardised 95% CIs for the difference between groups in terms of percentage of subjects with antibody concentration ≥ to the pre-defined cut-off.|Difference between Co-administration Group minus Staggered Group in terms of percentage of subjects with anti-PT antibody concentration ≥ 10 IU/mL.||9.12|-2.7|
72421762|NCT05375955|144354780|OTHER||Risk Difference (RD)|28.3||||0.0028|TWO_SIDED|95.0|7.7|47.5|||Chan and Zhang (1999) method|||||47.5|7.7|0.0028
72421763|NCT05375955|144354780|OTHER||Risk Difference (RD)|36.6||||0.0003|TWO_SIDED|95.0|14.7|56.4|||Chan and Zhang (1999) method|||||56.4|14.7|0.0003
72421764|NCT05375955|144354781|OTHER||Risk Difference (RD)|0.1||||0.5701|TWO_SIDED|95.0|-10.2|10.7|||Chan and Zhang (1999) method|||Week 1||10.7|-10.2|0.5701
72421765|NCT05375955|144354781|OTHER||Risk Difference (RD)|2.5||||0.3269|TWO_SIDED|95.0|-8.4|14.1|||Chan and Zhang (1999) method|||Week 1||14.1|-8.4|0.3269
72421766|NCT05375955|144354781|OTHER||Risk Difference (RD)|9.6||||0.0532|TWO_SIDED|95.0|-2.0|23.7|||Chan and Zhang (1999) method|||Week 2||23.7|-2.0|0.0532
72421767|NCT05375955|144354781|OTHER||Risk Difference (RD)|4.9||||0.1705|TWO_SIDED|95.0|-6.1|17.6|||Chan and Zhang (1999) method|||Week 2||17.6|-6.1|0.1705
72421768|NCT05375955|144354781|OTHER||Risk Difference (RD)|0.5||||0.5123|TWO_SIDED|95.0|-14.4|15.7|||Chan and Zhang (1999) method|||Week 4||15.7|-14.4|0.5123
72421769|NCT05375955|144354781|OTHER||Risk Difference (RD)|5.3||||0.2751|TWO_SIDED|95.0|-10.7|22.1|||Chan and Zhang (1999) method|||Week 4||22.1|-10.7|0.2751
72421770|NCT05375955|144354781|OTHER||Risk Difference (RD)|7.8||||0.2736|TWO_SIDED|95.0|-8.9|24.8|||Chan and Zhang (1999) method|||Week 6||24.8|-8.9|0.2736
72421771|NCT05375955|144354781|OTHER||Risk Difference (RD)|3.0||||0.3967|TWO_SIDED|95.0|-13.0|19.8|||Chan and Zhang (1999) method|||Week 6||19.8|-13.0|0.3967
72421772|NCT05375955|144354781|OTHER||Risk Difference (RD)|3.1||||0.3997|TWO_SIDED|95.0|-13.6|20.2|||Chan and Zhang (1999) method|||Week 8||20.2|-13.6|0.3997
72421773|NCT05375955|144354781|OTHER||Risk Difference (RD)|-1.6||||0.5461|TWO_SIDED|95.0|-17.7|15.3|||Chan and Zhang (1999) method|||Week 8||15.3|-17.7|0.5461
72421774|NCT05375955|144354781|OTHER||Risk Difference (RD)|7.8||||0.2736|TWO_SIDED|95.0|-8.9|24.8|||Chan and Zhang (1999) method|||Week 10||24.8|-8.9|0.2736
72421775|NCT05375955|144354781|OTHER||Risk Difference (RD)|5.4||||0.2754|TWO_SIDED|95.0|-11.0|22.1|||Chan and Zhang (1999) method|||Week 10||22.1|-11.0|0.2754
72421776|NCT05375955|144354781|OTHER||Risk Difference (RD)|12.6||||0.0977|TWO_SIDED|95.0|-4.8|30.3|||Chan and Zhang (1999) method|||Week 12||30.3|-4.8|0.0977
72421777|NCT05375955|144354781|OTHER||Risk Difference (RD)|14.9||||0.0542|TWO_SIDED|95.0|-2.8|33.2|||Chan and Zhang (1999) method|||Week 12||33.2|-2.8|0.0542
72421778|NCT05375955|144354782|OTHER||Risk Difference (RD)|3.0||||0.2578|TWO_SIDED|95.0|-7.8|15.8|||Chan and Zhang (1999) method|||Week 1||15.8|-7.8|0.2578
72421779|NCT05375955|144354782|OTHER||Risk Difference (RD)|0.0||||1|TWO_SIDED|95.0|-10.6|10.1|||Chan and Zhang (1999) method|||Week 1||10.1|-10.6|1.0000
72421780|NCT05375955|144354782|OTHER||Risk Difference (RD)|9.1||||0.0436|TWO_SIDED|95.0|-2.1|24.3|||Chan and Zhang (1999) method|||Week 1||24.3|-2.1|0.0436
72421781|NCT05375955|144354782|OTHER||Risk Difference (RD)|9.1||||0.0436|TWO_SIDED|95.0|-2.1|24.3|||Chan and Zhang (1999) method|||Week 2||24.3|-2.1|0.0436
72421782|NCT05375955|144354782|OTHER||Risk Difference (RD)|2.9||||0.2697|TWO_SIDED|95.0|-7.8|14.9|||Chan and Zhang (1999) method|||Week 2||14.9|-7.8|0.2697
72421783|NCT05375955|144354782|OTHER||Risk Difference (RD)|15.2||||0.0104|TWO_SIDED|95.0|3.2|32.0|||Chan and Zhang (1999) method|||Week 2||32.0|3.2|0.0104
72421784|NCT05375955|144354782|OTHER||Risk Difference (RD)|15.2||||0.0104|TWO_SIDED|95.0|3.2|32.0|||Chan and Zhang (1999) method|||Week 4||32.0|3.2|0.0104
72421785|NCT05375955|144354782|OTHER||Risk Difference (RD)|14.3||||0.0129|TWO_SIDED|95.0|2.6|30.3|||Chan and Zhang (1999) method|||Week 4||30.3|2.6|0.0129
72421786|NCT05375955|144354782|OTHER||Risk Difference (RD)|21.2||||0.0024|TWO_SIDED|95.0|8.0|38.9|||Chan and Zhang (1999) method|||Week 4||38.9|8.0|0.0024
72421787|NCT05375955|144354782|OTHER||Risk Difference (RD)|21.2||||0.0024|TWO_SIDED|95.0|8.0|38.9|||Chan and Zhang (1999) method|||Week 6||38.9|8.0|0.0024
72421788|NCT05375955|144354782|OTHER||Risk Difference (RD)|22.9||||0.0018|TWO_SIDED|95.0|9.5|40.1|||Chan and Zhang (1999) method|||Week 6||40.1|9.5|0.0018
72421789|NCT05375955|144354782|OTHER||Risk Difference (RD)|33.3||||0.0001|TWO_SIDED|95.0|17.8|51.8|||Chan and Zhang (1999) method|||Week 6||51.8|17.8|0.0001
72421790|NCT05375955|144354782|OTHER||Risk Difference (RD)|15.2||||0.0259|TWO_SIDED|95.0|-0.1|32.5|||Chan and Zhang (1999) method|||Week 8||32.5|-0.1|0.0259
72421791|NCT05375955|144354782|OTHER||Risk Difference (RD)|22.8||||0.0038|TWO_SIDED|95.0|6.3|40.4|||Chan and Zhang (1999) method|||Week 8||40.4|6.3|0.0038
72421792|NCT05375955|144354782|OTHER||Risk Difference (RD)|30.4||||0.0007|TWO_SIDED|95.0|12.2|48.9|||Chan and Zhang (1999) method|||Week 8||48.9|12.2|0.0007
72421793|NCT05375955|144354782|OTHER||Risk Difference (RD)|21.5||||0.0146|TWO_SIDED|95.0|2.1|41.2|||Chan and Zhang (1999) method|||Week 10||41.2|2.1|0.0146
72421794|NCT05375955|144354782|OTHER||Risk Difference (RD)|19.7||||0.0205|TWO_SIDED|95.0|1.0|38.9|||Chan and Zhang (1999) method|||Week 10||38.9|1.0|0.0205
72421795|NCT05375955|144354782|OTHER||Risk Difference (RD)|39.7||||0.0002|TWO_SIDED|95.0|17.1|59.3|||Chan and Zhang (1999) method|||Week 10||59.3|17.1|0.0002
72421796|NCT05375955|144354782|OTHER||Risk Difference (RD)|12.6||||0.1245|TWO_SIDED|95.0|-7.8|32.6|||Chan and Zhang (1999) method|||Week 12||32.6|-7.8|0.1245
72421797|NCT05375955|144354782|OTHER||Risk Difference (RD)|11.0||||0.1431|TWO_SIDED|95.0|-9.1|31.5|||Chan and Zhang (1999) method|||Week 12||31.5|-9.1|0.1431
72421798|NCT05375955|144354782|OTHER||Risk Difference (RD)|36.8||||0.0007|TWO_SIDED|95.0|12.2|56.8|||Chan and Zhang (1999) method|||Week 12||56.8|12.2|0.0007
72421799|NCT05375955|144354783|OTHER||Risk Difference (RD)|2.5||||0.3269|TWO_SIDED|95.0|-8.4|14.1|||Chan and Zhang (1999) method|||Week 1||14.1|-8.4|0.3269
72421800|NCT05375955|144354783|OTHER||Risk Difference (RD)|2.5||||0.3269|TWO_SIDED|95.0|-8.4|14.1|||Chan and Zhang (1999) method|||Week 1||14.1|-8.4|0.3269
72421801|NCT05375955|144354783|OTHER||Risk Difference (RD)|4.9||||0.1705|TWO_SIDED|95.0|-6.1|17.6|||Chan and Zhang (1999) method|||Week 2||17.6|-6.1|0.1705
72421802|NCT05375955|144354783|OTHER||Risk Difference (RD)|7.3||||0.1118|TWO_SIDED|95.0|-3.9|20.5|||Chan and Zhang (1999) method|||Week 2||20.5|-3.9|0.1118
72421803|NCT05375955|144354783|OTHER||Risk Difference (RD)|5.2||||0.2751|TWO_SIDED|95.0|-9.5|20.5|||Chan and Zhang (1999) method|||Week 4||20.5|-9.5|0.2751
72421804|NCT05375955|144354783|OTHER||Risk Difference (RD)|2.8||||0.3857|TWO_SIDED|95.0|-11.4|17.6|||Chan and Zhang (1999) method|||Week 4||17.6|-11.4|0.3857
72421805|NCT05375955|144354783|OTHER||Risk Difference (RD)|7.5||||0.1429|TWO_SIDED|95.0|-6.4|22.6|||Chan and Zhang (1999) method|||Week 6||22.6|-6.4|0.1429
72421806|NCT05375955|144354783|OTHER||Risk Difference (RD)|7.5||||0.1429|TWO_SIDED|95.0|-6.4|22.6|||Chan and Zhang (1999) method|||Week 6||22.6|-6.4|0.1429
72421807|NCT05375955|144354783|OTHER||Risk Difference (RD)|9.8||||0.1119|TWO_SIDED|95.0|-4.4|25.3|||Chan and Zhang (1999) method|||Week 8||25.3|-4.4|0.1119
72421808|NCT05375955|144354783|OTHER||Risk Difference (RD)|2.7||||0.3755|TWO_SIDED|95.0|-10.7|16.7|||Chan and Zhang (1999) method|||Week 8||16.7|-10.7|0.3755
72421809|NCT05375955|144354783|OTHER||Risk Difference (RD)|7.7||||0.2547|TWO_SIDED|95.0|-8.4|24.3|||Chan and Zhang (1999) method|||Week 10||24.3|-8.4|0.2547
72421810|NCT05375955|144354783|OTHER||Risk Difference (RD)|2.9||||0.3928|TWO_SIDED|95.0|-12.7|18.6|||Chan and Zhang (1999) method|||Week 10||18.6|-12.7|0.3928
72421811|NCT05375955|144354784|OTHER||Risk Difference (RD)|0.0||||1|TWO_SIDED|95.0|-10.6|11.0|||Chan and Zhang (1999) method|||Week 1||11.0|-10.6|1.0000
72421812|NCT05375955|144354784|OTHER||Risk Difference (RD)|0.0||||1|TWO_SIDED|95.0|-10.6|10.1|||Chan and Zhang (1999) method|||Week 1||10.1|-10.6|1.0000
72421813|NCT05375955|144354784|OTHER||Risk Difference (RD)|3.0||||0.2578|TWO_SIDED|95.0|-7.8|15.8|||Chan and Zhang (1999) method|||Week 1||15.8|-7.8|0.2578
72421814|NCT05375955|144354784|OTHER||Risk Difference (RD)|6.1||||0.0993|TWO_SIDED|95.0|-4.9|20.7|||Chan and Zhang (1999) method|||Week 2||20.7|-4.9|0.0993
72421815|NCT05375955|144354784|OTHER||Risk Difference (RD)|5.7||||0.114|TWO_SIDED|95.0|-5.3|19.2|||Chan and Zhang (1999) method|||Week 2||19.2|-5.3|0.1140
72330432|NCT02907216|144186119|NON_INFERIORITY|Criteria for non-inferiority: The LL of the standardised asymptotic 95% CI on the difference (Co-administration Group minus Staggered Group) in the percentage of subjects with seroprotective concentrations ≥ 10 IU/mL for anti-FHA antibodies should be ≥ -10%.|Difference-Seroprotective concentration|0.0|||||TWO_SIDED|95.0|-2.66|2.72|||||The 2-sided asymptotic standardised 95% CIs for the difference between groups in terms of percentage of subjects with antibody concentration ≥ to the pre-defined cut-off.|Difference between Co-administration Group minus Staggered Group in terms of percentage of subjects with anti-FHA antibody concentration ≥ 10 IU/mL.||2.72|-2.66|
72330433|NCT02907216|144186120|NON_INFERIORITY|Criteria for non-inferiority: The LL of the standardised asymptotic 95% CI on the difference (Co-administration Group minus Staggered Group) in the percentage of subjects with seroprotective titers ≥ 8 ED50 for anti-polio 1 antibodies should be ≥ -10%.|Difference in seroprotective titer|0.0|||||TWO_SIDED|95.0|-2.68|2.74|||||The 2-sided asymptotic standardised 95% CIs for the difference between groups in terms of percentage of subjects with antibody concentration ≥ to the pre-defined cut-off.|Difference between Co-administration Group minus Staggered Group in terms of percentage of subjects with anti-polio 1 seroprotective titres ≥ 8 ED50.||2.74|-2.68|
72330434|NCT02907216|144186120|NON_INFERIORITY|Criteria for non-inferiority: The LL of the standardised asymptotic 95% CI on the difference (Co-administration Group minus Staggered Group) in the percentage of subjects with seroprotective titers ≥ 8 ED50 for anti-polio 2 antibodies should be ≥ -10%.|Difference in seroprotective titer|0.0|||||TWO_SIDED|95.0|-2.92|2.95|||||The 2-sided asymptotic standardised 95% CIs for the difference between groups in terms of percentage of subjects with antibody concentration ≥ to the pre-defined cut-off.|Difference between Co-administration Group minus Staggered Group in terms of percentage of subjects with anti-polio 2 seroprotective titres ≥ 8 ED50.||2.95|-2.92|
72330435|NCT02907216|144186120|NON_INFERIORITY|Criteria for non-inferiority: The LL of the standardised asymptotic 95% CI on the difference (Co-administration Group minus Staggered Group) in the percentage of subjects with seroprotective titers ≥ 8 ED50 for anti-polio 3 antibodies should be ≥ -10%.|Difference in seroprotective titer|0.81|||||TWO_SIDED|95.0|-2.04|4.47|||||The 2-sided asymptotic standardised 95% CIs for the difference between groups in terms of percentage of subjects with antibody concentration ≥ to the pre-defined cut-off.|Difference between Co-administration Group minus Staggered Group in terms of percentage of subjects with anti-polio 3 seroprotective titres ≥ 8 ED50.||4.47|-2.04|
72368875|NCT03284307|144247453|SUPERIORITY||Slope|0.11|STANDARD_ERROR_OF_MEAN|0.043||0.012|TWO_SIDED|||||Statistical significance defined by p \< 0.05.|Mixed Models Analysis||Estimate is a slope from a linear mixed effects model representing the difference in occipital delta power between unconsciousness and disconnected consciousness after adjusting for within-subject effects.|Dexmedetomidine, Unconsciousness vs Disconnected Consciousness||||0.012
72421816|NCT05375955|144354784|OTHER||Risk Difference (RD)|9.1||||0.0436|TWO_SIDED|95.0|-2.1|24.3|||Chan and Zhang (1999) method|||Week 2||24.3|-2.1|0.0436
72421817|NCT05375955|144354784|OTHER||Risk Difference (RD)|6.1||||0.0993|TWO_SIDED|95.0|-4.9|20.7|||Chan and Zhang (1999) method|||Week 4||20.7|-4.9|0.0993
72421818|NCT05375955|144354784|OTHER||Risk Difference (RD)|17.1||||0.0071|TWO_SIDED|95.0|4.9|33.9|||Chan and Zhang (1999) method|||Week 4||33.9|4.9|0.0071
72421819|NCT05375955|144354784|OTHER||Risk Difference (RD)|15.2||||0.0104|TWO_SIDED|95.0|3.2|32.0|||Chan and Zhang (1999) method|||Week 4||32.0|3.2|0.0104
72421820|NCT05375955|144354784|OTHER||Risk Difference (RD)|15.2||||0.0104|TWO_SIDED|95.0|3.2|32.0|||Chan and Zhang (1999) method|||Week 6||32.0|3.2|0.0104
72421821|NCT05375955|144354784|OTHER||Risk Difference (RD)|17.1||||0.0071|TWO_SIDED|95.0|4.9|33.9|||Chan and Zhang (1999) method|||Week 6||33.9|4.9|0.0071
72421822|NCT05375955|144354784|OTHER||Risk Difference (RD)|24.2||||0.0011|TWO_SIDED|95.0|10.4|42.3|||Chan and Zhang (1999) method|||Week 6||42.3|10.4|0.0011
72421823|NCT05375955|144354784|OTHER||Risk Difference (RD)|9.1||||0.0436|TWO_SIDED|95.0|-2.1|24.3|||Chan and Zhang (1999) method|||Week 8||24.3|-2.1|0.0436
72421824|NCT05375955|144354784|OTHER||Risk Difference (RD)|28.6||||0.0003|TWO_SIDED|95.0|14.2|46.3|||Chan and Zhang (1999) method|||Week 8||46.3|14.2|0.0003
72421825|NCT05375955|144354784|OTHER||Risk Difference (RD)|27.3||||0.0007|TWO_SIDED|95.0|12.9|45.8|||Chan and Zhang (1999) method|||Week 8||45.8|12.9|0.0007
72421826|NCT05375955|144354784|OTHER||Risk Difference (RD)|9.3||||0.1256|TWO_SIDED|95.0|-6.6|26.4|||Chan and Zhang (1999) method|||Week 10||26.4|-6.6|0.1256
72421827|NCT05375955|144354784|OTHER||Risk Difference (RD)|25.5||||0.0038|TWO_SIDED|95.0|7.0|44.8|||Chan and Zhang (1999) method|||Week 10||44.8|7.0|0.0038
72421828|NCT05375955|144354784|OTHER||Risk Difference (RD)|33.5||||0.0007|TWO_SIDED|95.0|12.8|52.6|||Chan and Zhang (1999) method|||Week 10||52.6|12.8|0.0007
72421829|NCT05375955|144354785|OTHER||Risk Difference (RD)|2.5||||0.3269|TWO_SIDED|95.0|-8.4|14.1|||Chan and Zhang (1999) method|||Week 1||14.1|-8.4|0.3269
72421830|NCT05375955|144354785|OTHER||Risk Difference (RD)|2.5||||0.3269|TWO_SIDED|95.0|-8.4|14.1|||Chan and Zhang (1999) method|||Week 1||14.1|-8.4|0.3269
72421831|NCT05375955|144354785|OTHER||Risk Difference (RD)|2.6||||0.3585|TWO_SIDED|95.0|-9.2|15.5|||Chan and Zhang (1999) method|||Week 2||15.5|-9.2|0.3585
72421832|NCT05375955|144354785|OTHER||Risk Difference (RD)|7.4||||0.129|TWO_SIDED|95.0|-5.3|22.1|||Chan and Zhang (1999) method|||Week 2||22.1|-5.3|0.1290
72421833|NCT05375955|144354785|OTHER||Risk Difference (RD)|5.3||||0.2751|TWO_SIDED|95.0|-10.7|22.1|||Chan and Zhang (1999) method|||Week 4||22.1|-10.7|0.2751
72421834|NCT05375955|144354785|OTHER||Risk Difference (RD)|7.7||||0.2547|TWO_SIDED|95.0|-8.4|24.3|||Chan and Zhang (1999) method|||Week 4||24.3|-8.4|0.2547
72421835|NCT05375955|144354785|OTHER||Risk Difference (RD)|5.2||||0.2751|TWO_SIDED|95.0|-9.5|20.5|||Chan and Zhang (1999) method|||Week 6||20.5|-9.5|0.2751
72421836|NCT05375955|144354785|OTHER||Risk Difference (RD)|12.3||||0.0658|TWO_SIDED|95.0|-3.8|28.8|||Chan and Zhang (1999) method|||Week 6||28.8|-3.8|0.0658
72421837|NCT05375955|144354785|OTHER||Risk Difference (RD)|5.3||||0.2751|TWO_SIDED|95.0|-10.7|22.1|||Chan and Zhang (1999) method|||Week 8||22.1|-10.7|0.2751
72421838|NCT05375955|144354785|OTHER||Risk Difference (RD)|5.3||||0.2751|TWO_SIDED|95.0|-10.7|22.1|||Chan and Zhang (1999) method|||Week 8||22.1|-10.7|0.2751
72421839|NCT05375955|144354785|OTHER||Risk Difference (RD)|3.1||||0.3997|TWO_SIDED|95.0|-13.6|20.2|||Chan and Zhang (1999) method|||Week 10||20.2|-13.6|0.3997
72421840|NCT05375955|144354785|OTHER||Risk Difference (RD)|3.1||||0.3997|TWO_SIDED|95.0|-13.6|20.2|||Chan and Zhang (1999) method|||Week 10||20.2|-13.6|0.3997
72421841|NCT05375955|144354785|OTHER||Risk Difference (RD)|7.9||||0.2736|TWO_SIDED|95.0|-9.5|25.7|||Chan and Zhang (1999) method|||Week 12||25.7|-9.5|0.2736
72421842|NCT05375955|144354785|OTHER||Risk Difference (RD)|12.7||||0.1119|TWO_SIDED|95.0|-5.6|31.0|||Chan and Zhang (1999) method|||Week 12||31.0|-5.6|0.1119
72421843|NCT05375955|144354786|OTHER||Risk Difference (RD)|0.0||||1|TWO_SIDED|95.0|-10.6|11.0|||Chan and Zhang (1999) method|||Week 1||11.0|-10.6|1.0000
72421844|NCT05375955|144354786|OTHER||Risk Difference (RD)|2.9||||0.2697|TWO_SIDED|95.0|-7.8|14.9|||Chan and Zhang (1999) method|||Week 1||14.9|-7.8|0.2697
72421845|NCT05375955|144354786|OTHER||Risk Difference (RD)|3.0||||0.2578|TWO_SIDED|95.0|-7.8|15.8|||Chan and Zhang (1999) method|||Week 1||15.8|-7.8|0.2578
72421846|NCT05375955|144354786|OTHER||Risk Difference (RD)|6.1||||0.0993|TWO_SIDED|95.0|-4.9|20.7|||Chan and Zhang (1999) method|||Week 2||20.7|-4.9|0.0993
72330436|NCT00943098|144186202|NON_INFERIORITY_OR_EQUIVALENCE|The sample size calculation was based on a hypothesis of non-inferiority of Diclofenac HPBCD 75mg/ml s.c. versus Voltarol® 75mg/3ml i.m. with regard to the primary efficacy variable (PID at 1.5 hours after study drug administration). The clinically significant difference (delta) between groups was defined in 15 mm of pain intensity difference (a 30% decline from starting levels of pain intensity of 50 mm or greater on a 0 to 100 VAS).|Mean Difference (Final Values)|-0.71||||0.813|TWO_SIDED|95.0|-6.62|5.2|||ANCOVA|||Assuming a difference in means of 0 mm, a common standard deviation of 22.5 mm, a sample size of 60 subjects in each group had 95% power to reject the null hypothesis.||5.20|-6.62|0.813
72368876|NCT03284307|144247453|SUPERIORITY||Slope|-0.238|STANDARD_ERROR_OF_MEAN|0.199||0.236|TWO_SIDED|||||Statistical significance defined by p \< 0.05.|Mixed Models Analysis||Estimate is a slope from a linear mixed effects model representing the difference in occipital delta power between unconsciousness and disconnected consciousness after adjusting for within-subject effects.|Ketamine, Unconsciousness vs Disconnected Consciousness||||0.236
72421847|NCT05375955|144354786|OTHER||Risk Difference (RD)|5.7||||0.114|TWO_SIDED|95.0|-5.3|19.2|||Chan and Zhang (1999) method|||Week 2||19.2|-5.3|0.1140
72330437|NCT00943098|144186215|NON_INFERIORITY_OR_EQUIVALENCE|The sample size calculation was based on a hypothesis of non-inferiority of Diclofenac HPBCD 75mg/ml s.c. versus Voltarol® 75mg/3ml i.m. with regard to the primary efficacy variable (PID at 1.5 hours after study drug administration). The clinically significant difference (delta) between groups was defined in 15 mm of pain intensity difference (a 30% decline from starting levels of pain intensity of 50 mm or greater on a 0 to 100 VAS).|Mean Difference (Final Values)|-0.51||||0.862|TWO_SIDED|95.0|-6.23|5.22|||ANCOVA|||Assuming a difference in means of 0 mm, a common standard deviation of 22.5 mm, a sample size of 60 subjects in each group had 95% power to reject the null hypothesis.||5.22|-6.23|0.862
72330438|NCT04621240|144186221|SUPERIORITY|Mean level change from pre- to post-testing|Mean Difference (Net)|10.3|||<|0.001|TWO_SIDED||||||t-test, 2 sided|||||||<0.001
72330439|NCT04621240|144186221|OTHER|Regression of the change in BrainHealth Index on age|Slope|0.03||||0.55|TWO_SIDED||||||Regression, Linear|||||||0.55
72330440|NCT05926544|144186237|SUPERIORITY||Risk Ratio (RR)|0.46|||||TWO_SIDED|95.0|0.18|1.16|||||The Standard implementation arm was the reference group.|||1.16|0.18|
72330441|NCT03522246|144186238|SUPERIORITY|Rucaparib vs Placebo|Hazard Ratio (HR)|0.47||||0.0004|TWO_SIDED|95.0|0.31|0.72|||Log Rank||The stratified cox proportional hazard model is adjusted for the randomization strata of HRD classification and timing of surgery.|||0.72|0.31|0.0004
72330442|NCT03522246|144186239|SUPERIORITY|Rucaparib vs Placebo|Hazard Ratio (HR)|0.52|||<|0.0001|TWO_SIDED|95.0|0.4|0.68|||Log Rank||The stratified cox proportional hazard model is adjusted for the randomization strata of HRD classification, disease status post-chemotherapy, and timing of surgery.|||0.68|0.40|<0.0001
72330443|NCT03522246|144186240|SUPERIORITY|Rucaparib + Nivolumab vs Rucaparib + Placebo|Hazard Ratio (HR)|1.29||||0.0038|TWO_SIDED|95.0|1.08|1.53|||Log Rank||The stratified cox proportional hazard model is adjusted for the randomization strata of HRD classification, disease status post-chemotherapy, and timing of surgery.|||1.53|1.08|0.0038
72330444|NCT04683029|144186253|SUPERIORITY||LS Mean Difference|-12.6|||<|0.001|TWO_SIDED|80.0|-13.8|-11.4|||MMRM model|||||-11.4|-13.8|< 0.001
72330445|NCT04683029|144186254|SUPERIORITY||LS Mean Difference|-12.0|||||TWO_SIDED|80.0|-13.3|-10.7||||||||-10.7|-13.3|
72330446|NCT04683029|144186255|SUPERIORITY||Odds Ratio (OR)|0.1|||||TWO_SIDED|80.0|0.0|0.3||||||Week 24||0.3|0.0|
72330447|NCT04683029|144186255|SUPERIORITY||Odds Ratio (OR)|0.1|||||TWO_SIDED|80.0|0.0|0.2||||||Week 52||0.2|0.0|
72330448|NCT04683029|144186256|SUPERIORITY||Odds Ratio (OR)|203.2|||||TWO_SIDED|80.0|42.1|980.6||||||Week 24||980.6|42.1|
72330449|NCT04683029|144186256|SUPERIORITY||Odds Ratio (OR)|130.3|||||TWO_SIDED|80.0|28.2|601.9||||||Week 52||601.9|28.2|
72330450|NCT04683029|144186257|SUPERIORITY||LS Mean Difference|-47.2|||||TWO_SIDED|80.0|-96.8|2.4||||||Week 24||2.4|-96.8|
72330451|NCT04683029|144186257|SUPERIORITY||LS Mean difference|-14.2|||||TWO_SIDED|80.0|-57.2|28.8||||||Week 52||28.8|-57.2|
72330452|NCT04683029|144186258|SUPERIORITY||LS Mean Difference|0.0|||||TWO_SIDED|80.0|-1.7|1.6||||||Week 24||1.6|-1.7|
72330453|NCT04683029|144186258|SUPERIORITY||LS Mean Difference|0.1|||||TWO_SIDED|80.0|-1.4|1.7||||||Week 52||1.7|-1.4|
72330454|NCT04683029|144186259|SUPERIORITY||LS Mean Difference|-0.08|||||TWO_SIDED|80.0|-0.44|0.27||||||Week 24||0.27|-0.44|
72330455|NCT04683029|144186259|SUPERIORITY||LS Mean Difference|0.21|||||TWO_SIDED|80.0|-0.29|0.71||||||Week 52||0.71|-0.29|
72330456|NCT04683029|144186260|SUPERIORITY||LS Mean Difference|-2.08|||||TWO_SIDED|80.0|-3.81|-0.34||||||Week 24||-0.34|-3.81|
72330457|NCT04683029|144186260|SUPERIORITY||LS Mean Difference|0.14|||||TWO_SIDED|80.0|-2.13|2.42||||||Week 52||2.42|-2.13|
72330458|NCT04683029|144186261|SUPERIORITY||LS Mean Difference|-4.9|||||TWO_SIDED|80.0|-5.7|-4.0||||||Week 24||-4.0|-5.7|
72330459|NCT04683029|144186261|SUPERIORITY||LS Mean Difference|-4.3|||||TWO_SIDED|80.0|-5.1|-3.5||||||Week 52||-3.5|-5.1|
72330460|NCT04683029|144186262|SUPERIORITY||LS Mean Difference|-0.4006|||||TWO_SIDED|80.0|-0.5344|-0.2668||||||Week 24||-0.2668|-0.5344|
72330461|NCT04683029|144186262|SUPERIORITY||LS Mean Difference|-0.2355|||||TWO_SIDED|80.0|-0.373|-0.098||||||Week 52||-0.0980|-0.3730|
72330462|NCT00814580|144186273|NON_INFERIORITY_OR_EQUIVALENCE|Primary hypothesis test for non-inferiority of tapentadol IR over oxycodone IR required that upper limit of 95% CI for LS mean difference (oxycodone IR minus tapentadol IR) was less than the inferiority margin (\< 72). If the upper limit was less than 0 then tapentadol IR was superior to oxycodone IR for SPID over 3 days at a 5% level of significance.|Least square mean difference|9.0|STANDARD_ERROR_OF_MEAN|14.2||0.5265|TWO_SIDED|95.0|-18.9|36.9||Analysis of covariance (ANCOVA) model included baseline pain intensity score as the covariate and treatment and pooled center as class variables.|ANCOVA|||Tapentadol IR versus Oxycodone IR||36.9|-18.9|0.5265
72330463|NCT00814580|144186274|SUPERIORITY_OR_OTHER|||||||0.7306||95.0|||||Log Rank|||||||0.7306
72330464|NCT00814580|144186275|SUPERIORITY_OR_OTHER|||||||0.8524||95.0|||||Log Rank|||||||0.8524
72330465|NCT00814580|144186276|SUPERIORITY_OR_OTHER|||||||0.9078||95.0||||Cochran-Mantel-Haenszel test (Row Mean Score option) controlling for pooled investigator centers.|Cochran-Mantel-Haenszel|||||||0.9078
72330466|NCT00814580|144186277|SUPERIORITY_OR_OTHER|||||||0.2633||95.0||||Cochran-Mantel-Haenszel test (Row Mean Score option) controlling for pooled investigator centers.|Cochran-Mantel-Haenszel|||||||0.2633
72330467|NCT00814580|144186278|SUPERIORITY_OR_OTHER|||||||0.4498||95.0||||Cochran-Mantel-Haenszel test (Row Mean Score option) controlling for pooled investigator centers.|Cochran-Mantel-Haenszel|||||||0.4498
72330468|NCT00814580|144186279|SUPERIORITY_OR_OTHER|||||||0.2158||95.0||||Cochran-Mantel-Haenszel test (Row Mean Score option) controlling for pooled investigator centers.|Cochran-Mantel-Haenszel|||||||0.2158
72330469|NCT00814580|144186280|SUPERIORITY_OR_OTHER||Least square mean difference|6.6|STANDARD_ERROR_OF_MEAN|9.34||0.4811|TWO_SIDED|95.0|-11.8|25.0||Analysis of covariance (ANCOVA) model included baseline pain intensity score as the covariate and treatment and pooled center as class variables.|ANCOVA|||||25.0|-11.8|0.4811
72330470|NCT00814580|144186281|SUPERIORITY_OR_OTHER||Least square mean difference|-9.3|STANDARD_ERROR_OF_MEAN|28.13||0.7405|TWO_SIDED|95.0|-64.7|46.0||Analysis of covariance (ANCOVA) model included baseline pain intensity score as the covariate and treatment and pooled center as class variables.|ANCOVA|||||46.0|-64.7|0.7405
72330471|NCT00814580|144186282|SUPERIORITY_OR_OTHER||Least square mean difference|-5.6|STANDARD_ERROR_OF_MEAN|5.53||0.3097|TWO_SIDED|95.0|-16.5|5.3||Analysis of covariance (ANCOVA) model included baseline pain intensity score as the covariate and treatment and pooled center as class variables.|ANCOVA|||||5.3|-16.5|0.3097
72330472|NCT00814580|144186283|SUPERIORITY_OR_OTHER||Least square mean difference|-10.3|STANDARD_ERROR_OF_MEAN|8.34||0.2179|TWO_SIDED|95.0|-26.7|6.1||Analysis of covariance (ANCOVA) model included baseline pain intensity score as the covariate and treatment and pooled center as class variables.|ANCOVA|||||6.1|-26.7|0.2179
72330473|NCT00814580|144186284|SUPERIORITY_OR_OTHER||Least square mean difference|-26.3|STANDARD_ERROR_OF_MEAN|16.16||0.1051|TWO_SIDED|95.0|-58.1|5.5||Analysis of covariance (ANCOVA) model included baseline pain intensity score as the covariate and treatment and pooled center as class variables.|ANCOVA|||||5.5|-58.1|0.1051
72330474|NCT00814580|144186285|SUPERIORITY_OR_OTHER||Least square mean difference|1.0|STANDARD_ERROR_OF_MEAN|12.09||0.9367|TWO_SIDED|95.0|-22.8|24.8||Analysis of covariance (ANCOVA) model included baseline pain intensity score as the covariate and treatment and pooled center as class variables.|ANCOVA|||||24.8|-22.8|0.9367
72330475|NCT00814580|144186286|SUPERIORITY_OR_OTHER||Least square mean difference|-1.3|STANDARD_ERROR_OF_MEAN|18.53||0.9441|TWO_SIDED|95.0|-37.8|35.2||Analysis of covariance (ANCOVA) model included baseline pain intensity score as the covariate and treatment and pooled center as class variables.|ANCOVA|||||35.2|-37.8|0.9441
72330476|NCT00814580|144186287|SUPERIORITY_OR_OTHER||Least square mean difference|-35.6|STANDARD_ERROR_OF_MEAN|37.45||0.3427|TWO_SIDED|95.0|-109.3|38.1||Analysis of covariance (ANCOVA) model included baseline pain intensity score as the covariate and treatment and pooled center as class variables.|ANCOVA|||||38.1|-109.3|0.3427
72330477|NCT00814580|144186288|SUPERIORITY_OR_OTHER|||||||0.1618||95.0||||Cochran-Mantel-Haenszel test (row mean score option) controlling for pooled investigator centers.|Cochran-Mantel-Haenszel|||||||0.1618
72330478|NCT00814580|144186289|SUPERIORITY_OR_OTHER|||||||0.0481||95.0||||Cochran-Mantel-Haenszel test (row mean score option) controlling for pooled investigator centers.|Cochran-Mantel-Haenszel|||||||0.0481
72330479|NCT00814580|144186290|SUPERIORITY_OR_OTHER|||||||0.0109||95.0||||Cochran-Mantel-Haenszel test (row mean score option) controlling for pooled investigator centers|Cochran-Mantel-Haenszel|||||||0.0109
72421848|NCT05375955|144354786|OTHER||Risk Difference (RD)|9.1||||0.0436|TWO_SIDED|95.0|-2.1|24.3|||Chan and Zhang (1999) method|||Week 2||24.3|-2.1|0.0436
72421849|NCT05375955|144354786|OTHER||Risk Difference (RD)|6.1||||0.0993|TWO_SIDED|95.0|-4.9|20.7|||Chan and Zhang (1999) method|||Week 4||20.7|-4.9|0.0993
72421850|NCT05375955|144354786|OTHER||Risk Difference (RD)|17.1||||0.0071|TWO_SIDED|95.0|4.9|33.9|||Chan and Zhang (1999) method|||Week 4||33.9|4.9|0.0071
72421851|NCT05375955|144354786|OTHER||Risk Difference (RD)|15.2||||0.0104|TWO_SIDED|95.0|3.2|32.0|||Chan and Zhang (1999) method|||Week 4||32.0|3.2|0.0104
72421852|NCT05375955|144354786|OTHER||Risk Difference (RD)|15.2||||0.0104|TWO_SIDED|95.0|3.2|32.0|||Chan and Zhang (1999) method|||Week 6||32.0|3.2|0.0104
72330480|NCT02482428|144186307|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|p value is provided|Mean Difference (Net)|0.05|STANDARD_DEVIATION|0.07||0.862|TWO_SIDED|90.0|-0.03|0.2|||Posterior mean|||||0.20|-0.03|0.862
72330481|NCT02482428|144186307|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|p value is provided|Mean Difference (Net)|0.02|STANDARD_DEVIATION|0.07||0.541|TWO_SIDED|90.0|-0.07|0.19|||posterior mean|||||0.19|-0.07|0.541
72330482|NCT00335283|144186366|SUPERIORITY_OR_OTHER||Odds Ratio, log|3.12||||0.01|TWO_SIDED|95.0|1.28|7.59|||Regression, Logistic|||This applies to the 8 week treatment effect. A sample size of 33 patients in treated arm was considered sufficient to detect a difference of 35% between groups, assuming a lansoprazole treatment response of 70% and a placebo response of 35% with an alpha level of .05 and 90% power. A total of 75 patienst was considered an adequate sample size to allow for a 10% dropout rate.||7.59|1.28|.01
72330483|NCT00335283|144186366|SUPERIORITY_OR_OTHER||Odds Ratio, log|3.5||||0.006|TWO_SIDED|95.0|1.41|8.67|||Regression, Logistic|||This applies to the 16 week treatment affect. A sample size of 33 patients in treated arm was considered sufficient to detect a difference of 35% between groups, assuming a lansoprazole treatment response of 70% and a placebo response of 35% with an alpha level of .05 and 90% power. A total of 75 patienst was considered an adequate sample size to allow for a 10% dropout rate.||8.67|1.41|.006
72330484|NCT00335283|144186367|SUPERIORITY_OR_OTHER||Odds Ratio, log|1.01||||0.97|TWO_SIDED|95.0|0.38|2.7|||Regression, Logistic|||This applies to the 8 week treatment effect. A sample size of 33 patients in treated arm was considered sufficient to detect a difference of 35% between groups, assuming a lansoprazole treatment response of 70% and a placebo response of 35% with an alpha level of .05 and 90% power. A total of 75 patienst was considered an adequate sample size to allow for a 10% dropout rate.||2.70|0.38|.97
72421853|NCT05375955|144354786|OTHER||Risk Difference (RD)|17.1||||0.0071|TWO_SIDED|95.0|4.9|33.9|||Chan and Zhang (1999) method|||Week 6||33.9|4.9|0.0071
72421854|NCT05375955|144354786|OTHER||Risk Difference (RD)|24.2||||0.0011|TWO_SIDED|95.0|10.4|42.3|||Chan and Zhang (1999) method|||Week 6||42.3|10.4|0.0011
72421855|NCT05375955|144354786|OTHER||Risk Difference (RD)|9.1||||0.0436|TWO_SIDED|95.0|-2.1|24.3|||Chan and Zhang (1999) method|||Week 8||24.3|-2.1|0.0436
72421856|NCT05375955|144354786|OTHER||Risk Difference (RD)|28.6||||0.0003|TWO_SIDED|95.0|14.2|46.3|||Chan and Zhang (1999) method|||Week 8||46.3|14.2|0.0003
72421857|NCT05375955|144354786|OTHER||Risk Difference (RD)|27.3||||0.0007|TWO_SIDED|95.0|12.9|45.8|||Chan and Zhang (1999) method|||Week 8||45.8|12.9|0.0007
72421858|NCT05375955|144354786|OTHER||Risk Difference (RD)|6.3||||0.2712|TWO_SIDED|95.0|-10.8|24.3|||Chan and Zhang (1999) method|||Week 10||24.3|-10.8|0.2712
72421859|NCT05375955|144354786|OTHER||Risk Difference (RD)|25.5||||0.0056|TWO_SIDED|95.0|5.4|44.8|||Chan and Zhang (1999) method|||Week 10||44.8|5.4|0.0056
72421860|NCT05375955|144354786|OTHER||Risk Difference (RD)|30.6||||0.0017|TWO_SIDED|95.0|9.7|50.5|||Chan and Zhang (1999) method|||Week 10||50.5|9.7|0.0017
72421861|NCT05375955|144354786|OTHER||Risk Difference (RD)|3.4||||0.3929|TWO_SIDED|95.0|-14.9|21.6|||Chan and Zhang (1999) method|||Week 12||21.6|-14.9|0.3929
72421862|NCT05375955|144354786|OTHER||Risk Difference (RD)|28.2||||0.004|TWO_SIDED|95.0|7.0|47.7|||Chan and Zhang (1999) method|||Week 12||47.7|7.0|0.0040
72421863|NCT05375955|144354786|OTHER||Risk Difference (RD)|33.7||||0.0012|TWO_SIDED|95.0|10.4|53.7|||Chan and Zhang (1999) method|||Week 12||53.7|10.4|0.0012
72421864|NCT05375955|144354789|OTHER||Risk Difference (RD)|2.8||||0.3255|TWO_SIDED|95.0|-8.5|15.8|||Chan and Zhang (1999) method|||Week 1||15.8|-8.5|0.3255
72421865|NCT05375955|144354789|OTHER||Risk Difference (RD)|-2.5||||0.7181|TWO_SIDED|95.0|-13.3|8.3|||Chan and Zhang (1999) method|||Week 1||8.3|-13.3|0.7181
72421866|NCT05375955|144354789|OTHER||Risk Difference (RD)|18.4||||0.0022|TWO_SIDED|95.0|7.0|34.3|||Chan and Zhang (1999) method|||Week 2||34.3|7.0|0.0022
72330485|NCT00335283|144186367|SUPERIORITY_OR_OTHER||Odds Ratio, log|1.11||||0.84|TWO_SIDED|95.0|0.4|3.06|||Regression, Logistic|||This applies to the 16 week treatment effect. A sample size of 33 patients in treated arm was considered sufficient to detect a difference of 35% between groups, assuming a lansoprazole treatment response of 70% and a placebo response of 35% with an alpha level of .05 and 90% power. A total of 75 patienst was considered an adequate sample size to allow for a 10% dropout rate.||3.06|0.40|.84
72330486|NCT00335283|144186368|SUPERIORITY_OR_OTHER||Odds Ratio, log|2.44||||0.06|TWO_SIDED|95.0|0.95|6.31|||Regression, Logistic|||This applies to the 8 week treatment effect. A sample size of 33 patients in treated arm was considered sufficient to detect a difference of 35% between groups, assuming a lansoprazole treatment response of 70% and a placebo response of 35% with an alpha level of .05 and 90% power. A total of 75 patienst was considered an adequate sample size to allow for a 10% dropout rate.||6.31|.95|.06
72330487|NCT00335283|144186368|SUPERIORITY_OR_OTHER||Odds Ratio, log|4.51||||0.007|TWO_SIDED|95.0|1.5|13.6|||Regression, Logistic|||This applies to the 16 week treatment effect. A sample size of 33 patients in treated arm was considered sufficient to detect a difference of 35% between groups, assuming a lansoprazole treatment response of 70% and a placebo response of 35% with an alpha level of .05 and 90% power. A total of 75 patienst was considered an adequate sample size to allow for a 10% dropout rate.||13.6|1.5|.007
72330488|NCT00335283|144186369|SUPERIORITY_OR_OTHER||Odds Ratio, log|5.17||||0.006|TWO_SIDED|95.0|2.02|13.2|||Regression, Logistic|||This applies to the 8 week treatment effect. A sample size of 33 patients in treated arm was considered sufficient to detect a difference of 35% between groups, assuming a lansoprazole treatment response of 70% and a placebo response of 35% with an alpha level of .05 and 90% power. A total of 75 patienst was considered an adequate sample size to allow for a 10% dropout rate.||13.2|2.02|.006
72330489|NCT00335283|144186369|SUPERIORITY_OR_OTHER||Odds Ratio, log|5.31||||0.001|TWO_SIDED|95.0|1.97|14.3|||Regression, Logistic|||This applies to the 16 week treatment effect. A sample size of 33 patients in treated arm was considered sufficient to detect a difference of 35% between groups, assuming a lansoprazole treatment response of 70% and a placebo response of 35% with an alpha level of .05 and 90% power. A total of 75 patienst was considered an adequate sample size to allow for a 10% dropout rate.||14.3|1.97|.001
72330490|NCT03086408|144186407|OTHER||Mean Difference (Final Values)|-4.0||||0.09|TWO_SIDED|95.0|-9.0|1.0|||t-test, 2 sided|||||1.00|-9.00|0.09
72421867|NCT05375955|144354789|OTHER||Risk Difference (RD)|14.7||||0.0064|TWO_SIDED|95.0|3.7|31.1|||Chan and Zhang (1999) method|||Week 2||31.1|3.7|0.0064
72330491|NCT03086408|144186408|OTHER||Mean Difference (Final Values)|0.9||||0.61|TWO_SIDED|95.0|-2.89|4.69|||t-test, 2 sided|||||4.69|-2.89|0.61
72330492|NCT03086408|144186409|OTHER||Mean Difference (Final Values)|-0.07||||0.78|TWO_SIDED|95.0|-0.61|0.47|||t-test, 2 sided|||||0.47|-0.61|0.78
72330493|NCT03086408|144186410|OTHER||Mean Difference (Final Values)|-0.4||||0.3|TWO_SIDED|95.0|-1.3|0.5|||t-test, 2 sided|||||0.50|-1.30|0.30
72421868|NCT05375955|144354789|OTHER||Risk Difference (RD)|13.7||||0.0659|TWO_SIDED|95.0|-3.4|31.5|||Chan and Zhang (1999) method|||Week 4||31.5|-3.4|0.0659
72421869|NCT05375955|144354789|OTHER||Risk Difference (RD)|19.4||||0.0189|TWO_SIDED|95.0|0.9|38.5|||Chan and Zhang (1999) method|||Week 4||38.5|0.9|0.0189
72330494|NCT03086408|144186411|OTHER||Mean Difference (Final Values)|0.1||||0.98|TWO_SIDED|95.0|-8.62|8.82|||t-test, 2 sided|||||8.82|-8.62|0.98
72330495|NCT03086408|144186412|OTHER||Mean Difference (Final Values)|0.6||||0.61|TWO_SIDED|95.0|-1.64|2.84|||t-test, 2 sided|||||2.84|-1.64|0.61
72330496|NCT03086408|144186413|OTHER||Mean Difference (Final Values)|13.7||||0.04|TWO_SIDED|95.0|0.63|26.77|||t-test, 2 sided|||||26.77|0.63|0.04
72330497|NCT03086408|144186414|OTHER||Mean Difference (Final Values)|0.0||||1|TWO_SIDED|95.0|-2.8|2.8|||t-test, 2 sided|||||2.80|-2.80|1
72330498|NCT03086408|144186415|OTHER||Mean Difference (Final Values)|-0.2||||0.82|TWO_SIDED|95.0|-2.38|1.98|||t-test, 2 sided|||||1.98|-2.38|0.82
72330499|NCT03086408|144186416|OTHER||Mean Difference (Final Values)|-1.5||||0.37|TWO_SIDED|95.0|-5.29|2.29|||t-test, 2 sided|||||2.29|-5.29|0.37
72330500|NCT02277691|144186437|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||One sample t-test|||P-value has been estimated for change from baseline in office trough SBP at Week 12 (LOCF).||||<0.0001
72330501|NCT02277691|144186437|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||One sample t-test|||P-value has been estimated for change from baseline in office trough SBP at Week 52 (LOCF).||||<0.0001
72421870|NCT05375955|144354789|OTHER||Risk Difference (RD)|3.6||||0.3962|TWO_SIDED|95.0|-14.9|22.3|||Chan and Zhang (1999) method|||Week 6||22.3|-14.9|0.3962
72421871|NCT05375955|144354789|OTHER||Risk Difference (RD)|9.0||||0.2333|TWO_SIDED|95.0|-10.4|29.1|||Chan and Zhang (1999) method|||Week 6||29.1|-10.4|0.2333
72421872|NCT05375955|144354789|OTHER||Risk Difference (RD)|3.6||||0.3962|TWO_SIDED|95.0|-14.9|22.3|||Chan and Zhang (1999) method|||Week 8||22.3|-14.9|0.3962
72421873|NCT05375955|144354789|OTHER||Risk Difference (RD)|11.9||||0.1353|TWO_SIDED|95.0|-7.9|32.7|||Chan and Zhang (1999) method|||Week 8||32.7|-7.9|0.1353
72421874|NCT05375955|144354789|OTHER||Risk Difference (RD)|6.2||||0.2791|TWO_SIDED|95.0|-12.8|25.7|||Chan and Zhang (1999) method|||Week 10||25.7|-12.8|0.2791
72330502|NCT02277691|144186437|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||One sample t-test|||P-value has been estimated for change from baseline in office trough sitting DBP at Week 12 (LOCF).||||<0.0001
72330503|NCT02277691|144186437|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||One sample t-test|||P-value has been estimated for change from baseline in office trough sitting DBP at Week 52 (LOCF).||||<0.0001
72330504|NCT02277691|144186438|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||One sample t-test|||P-value has been estimated for change from baseline in home SBP, morning at End of Week 12.||||<0.0001
72330505|NCT02277691|144186438|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||One sample t-test|||P-value has been estimated for change from baseline in home SBP, morning at EOT (Up to Week 52).||||<0.0001
72330506|NCT02277691|144186438|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||One sample t-test|||P-value has been estimated for change from baseline in home DBP, morning at End of Week 12.||||<0.0001
72330507|NCT02277691|144186438|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||One sample t-test|||P-value has been estimated for change from baseline in home DBP, morning at EOT (Up to Week 52).||||<0.0001
72330508|NCT03818607|144186439|NON_INFERIORITY|The clinical similarity of the Week 27 LDH between treatments was assessed by comparing the 1-sided 97.5% upper confidence interval (CI) limit for the geometric mean ratio of LDH at Week 27 between ABP 959 treatment and eculizumab treatment with a non-inferiority margin of 2.873.|Geometric LS mean ratio (GMR)|1.0628|||||ONE_SIDED|97.5||1.1576||||||||1.1576||
72330509|NCT03818607|144186440|OTHER|The clinical similarity of the AUEC between treatments was assessed by comparing 2-sided 90% CI for the GMR of the time-adjusted AUEC of LDH (Week 13 to Week 27, Week 39 to Week 53, and Week 65 to Week 79) between ABP 959 treatment and eculizumab treatment with a similarity margin of (0.77, 1.30).|GMR|0.9812|||||TWO_SIDED|90.0|0.9403|1.0239||||||||1.0239|0.9403|
72330510|NCT03818607|144186448|OTHER||GMR|1.0314|||||ONE_SIDED|97.5||1.1201||||||||1.1201||
72330511|NCT03818607|144186451|OTHER||GMR|0.9122|||||TWO_SIDED|90.0|0.7586|1.0968||||||Total PK AUC GMR (ABP 959/Eculizumab)||1.0968|0.7586|
72330512|NCT03818607|144186451|OTHER||GMR|0.9508|||||TWO_SIDED|90.0|0.7454|1.213||||||Unbound PK AUC GMR (ABP 959/Eculizumab)||1.2130|0.7454|
72421875|NCT05375955|144354789|OTHER||Risk Difference (RD)|9.0||||0.2333|TWO_SIDED|95.0|-10.4|29.1|||Chan and Zhang (1999) method|||Week 10||29.1|-10.4|0.2333
72330513|NCT05059301|144186458|EQUIVALENCE|Clinical equivalence is demonstrated if the 2 sided 95% confidence interval (CI) of the GMC ratios (RSV OA\_Lot 1 divided by RSV OA\_Lot 2) is within the pre defined limit of \[0.67, 1.5\].|Adjusted group GMC ratio|1.06|||||TWO_SIDED|95.0|0.94|1.21||||||To demonstrate the clinical equivalence of RSV OA\_Lot 1 versus RSV OA\_Lot 2 in terms of RSV PreF3 IgG concentrations expressed as group GMC ratio at one month post vaccination. The 2-sided 95% CI for group GMC ratio was derived from an ANCOVA model on log10 transformed RSV PreF3 IgG antibody titers. The ANCOVA model included the treatment group and the age category (age at vaccination: 60-69, 70-79 or \>=80 years) and the center as fixed effects and the pre-dose log10 titer as covariate.||1.21|0.94|
72330514|NCT05059301|144186458|EQUIVALENCE|Clinical equivalence is demonstrated if the 2 sided 95% CI of the GMC ratios (RSV OA\_Lot 1 divided by RSV OA\_Lot 3) is within the pre defined limit of \[0.67, 1.5\].|Adjusted group GMC ratio|0.92|||||TWO_SIDED|95.0|0.81|1.04||||||To demonstrate the clinical equivalence of RSV OA\_Lot 1 versus RSV OA\_Lot 3 in terms of RSV PreF3 IgG concentrations expressed as group GMC ratio at one month post vaccination. The 2-sided 95% CI for group GMC ratio was derived from an ANCOVA model on log10 transformed RSV PreF3 IgG antibody titers. The ANCOVA model included the treatment group and the age category (age at vaccination: 60-69, 70-79 or \>=80 years) and the center as fixed effects and the pre-dose log10 titer as covariate.||1.04|0.81|
72421876|NCT05375955|144354789|OTHER||Risk Difference (RD)|11.3||||0.1295|TWO_SIDED|95.0|-7.3|30.6|||Chan and Zhang (1999) method|||Week 12||30.6|-7.3|0.1295
72421877|NCT05375955|144354789|OTHER||Risk Difference (RD)|20.3||||0.0247|TWO_SIDED|95.0|0.1|40.2|||Chan and Zhang (1999) method|||Week 12||40.2|0.1|0.0247
72421878|NCT05375955|144354790|OTHER||Risk Difference (RD)|-4.3||||0.7278|TWO_SIDED|95.0|-21.9|11.5|||Chan and Zhang (1999) method|||Week 1||11.5|-21.9|0.7278
72330515|NCT05059301|144186458|EQUIVALENCE|Clinical equivalence is demonstrated if the 2 sided 95% CI of the GMC ratios (RSV OA\_Lot 2 divided by RSV OA\_Lot 3) is within the pre defined limit of \[0.67, 1.5\].|Adjusted group GMC ratio|0.87|||||TWO_SIDED|95.0|0.77|0.99||||||To demonstrate the clinical equivalence of RSV OA\_Lot 2 versus RSV OA\_Lot 3 in terms of RSV PreF3 IgG concentrations expressed as group GMC ratio at one month post vaccination. The 2-sided 95% CI for group GMC ratio was derived from an ANCOVA model on log10 transformed RSV PreF3 IgG antibody titers. The ANCOVA model included the treatment group and the age category (age at vaccination: 60-69, 70-79 or \>=80 years) and the center as fixed effects and the pre-dose log10 titer as covariate.||0.99|0.77|
72330516|NCT03249909|144186504|NON_INFERIORITY|Analysis of the change in exudate status (Decrease, Equal/Unchanged, Increase) from baseline to 4 weeks in the treatment groups with the two-sided Sign test on the Intent To Treat (ITT) population at 95% confidence interval.||||||0.0019|||||||Sign test|||||||0.0019
72330517|NCT01864148|144186536|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.98||||0.9584|TWO_SIDED|95.0|0.46|2.07|||Regression, Logistic|Odds ratios, 95% CI and p-values are based on logistic regression adjusted for MS type, region and baseline component assessments.||||2.07|0.46|0.9584
72330518|NCT01864148|144186536|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.79||||0.0636|TWO_SIDED|95.0|0.97|3.31|||Regression, Logistic|Odds ratios, 95% CI and p-values are based on logistic regression adjusted for MS type, region and baseline component assessments.||||3.31|0.97|0.0636
72330519|NCT01864148|144186536|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.06||||0.022|TWO_SIDED|95.0|1.11|3.84|||Regression, Logistic|Odds ratios, 95% CI and p-values are based on logistic regression adjusted for MS type, region and baseline component assessments.||||3.84|1.11|0.0220
72421879|NCT05375955|144354790|OTHER||Risk Difference (RD)|8.2||||0.2548|TWO_SIDED|95.0|-11.5|28.2|||Chan and Zhang (1999) method|||Week 1||28.2|-11.5|0.2548
72421880|NCT05375955|144354790|OTHER||Risk Difference (RD)|0.9||||0.5162|TWO_SIDED|95.0|-17.5|21.9|||Chan and Zhang (1999) method|||Week 1||21.9|-17.5|0.5162
72421881|NCT05375955|144354790|OTHER||Risk Difference (RD)|9.3||||0.1663|TWO_SIDED|95.0|-11.4|30.7|||Chan and Zhang (1999) method|||Week 2||30.7|-11.4|0.1663
72421882|NCT05375955|144354790|OTHER||Risk Difference (RD)|16.5||||0.0605|TWO_SIDED|95.0|-4.2|38.3|||Chan and Zhang (1999) method|||Week 2||38.3|-4.2|0.0605
72421883|NCT05375955|144354790|OTHER||Risk Difference (RD)|16.7||||0.0592|TWO_SIDED|95.0|-5.4|41.6|||Chan and Zhang (1999) method|||Week 2||41.6|-5.4|0.0592
72421884|NCT05375955|144354790|OTHER||Risk Difference (RD)|14.0||||0.1246|TWO_SIDED|95.0|-8.6|37.4|||Chan and Zhang (1999) method|||Week 4||37.4|-8.6|0.1246
72421885|NCT05375955|144354790|OTHER||Risk Difference (RD)|16.3||||0.0789|TWO_SIDED|95.0|-7.3|39.7|||Chan and Zhang (1999) method|||Week 4||39.7|-7.3|0.0789
72421886|NCT05375955|144354790|OTHER||Risk Difference (RD)|17.6||||0.0889|TWO_SIDED|95.0|-6.4|43.7|||Chan and Zhang (1999) method|||Week 4||43.7|-6.4|0.0889
72421887|NCT05375955|144354790|OTHER||Risk Difference (RD)|27.5||||0.0097|TWO_SIDED|95.0|4.2|50.7|||Chan and Zhang (1999) method|||Week 6||50.7|4.2|0.0097
72421888|NCT05375955|144354790|OTHER||Risk Difference (RD)|20.7||||0.0294|TWO_SIDED|95.0|-0.8|43.6|||Chan and Zhang (1999) method|||Week 6||43.6|-0.8|0.0294
72421889|NCT05375955|144354790|OTHER||Risk Difference (RD)|37.8||||0.0018|TWO_SIDED|95.0|10.9|62.2|||Chan and Zhang (1999) method|||Week 6||62.2|10.9|0.0018
72421890|NCT05375955|144354790|OTHER||Risk Difference (RD)|23.5||||0.0495|TWO_SIDED|95.0|-3.8|48.9|||Chan and Zhang (1999) method|||Week 8||48.9|-3.8|0.0495
72421891|NCT05375955|144354790|OTHER||Risk Difference (RD)|7.6||||0.289|TWO_SIDED|95.0|-17.3|32.4|||Chan and Zhang (1999) method|||Week 8||32.4|-17.3|0.2890
72421892|NCT05375955|144354790|OTHER||Risk Difference (RD)|35.2||||0.0103|TWO_SIDED|95.0|5.1|62.0|||Chan and Zhang (1999) method|||Week 8||62.0|5.1|0.0103
72421893|NCT05375955|144354790|OTHER||Risk Difference (RD)|19.0||||0.1088|TWO_SIDED|95.0|-7.8|44.8|||Chan and Zhang (1999) method|||Week 10||44.8|-7.8|0.1088
72421894|NCT05375955|144354790|OTHER||Risk Difference (RD)|11.8||||0.2719|TWO_SIDED|95.0|-14.0|36.2|||Chan and Zhang (1999) method|||Week 10||36.2|-14.0|0.2719
72421895|NCT05375955|144354790|OTHER||Risk Difference (RD)|30.0||||0.0227|TWO_SIDED|95.0|0.4|56.6|||Chan and Zhang (1999) method|||Week 10||56.6|0.4|0.0227
72421896|NCT05375955|144354790|OTHER||Risk Difference (RD)|23.5||||0.0495|TWO_SIDED|95.0|-3.8|48.9|||Chan and Zhang (1999) method|||Week 12||48.9|-3.8|0.0495
72421897|NCT05375955|144354790|OTHER||Risk Difference (RD)|15.9||||0.1246|TWO_SIDED|95.0|-10.6|40.6|||Chan and Zhang (1999) method|||Week 12||40.6|-10.6|0.1246
72421898|NCT05375955|144354790|OTHER||Risk Difference (RD)|30.0||||0.0227|TWO_SIDED|95.0|0.4|56.6|||Chan and Zhang (1999) method|||Week 12||56.6|0.4|0.0227
72421899|NCT01320943|144354798|SUPERIORITY|||||||0.022||||||Log-rank test statistic was used to compare the time to HBsAg loss between the two treatment arms.|Log Rank|||||||0.022
72421900|NCT03937219|144354818|SUPERIORITY||Hazard Ratio (HR)|0.73||||0.0131|TWO_SIDED|95.0|0.57|0.94|||Log Rank|||||0.94|0.57|0.0131
72421901|NCT00361439|144354826|SUPERIORITY_OR_OTHER||||||<|0.02||95.0|||||Wilcoxon (Mann-Whitney)|||||||< 0.02
72421902|NCT00361439|144354827|SUPERIORITY_OR_OTHER||||||<|0.023||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.023
72421903|NCT00361439|144354828|SUPERIORITY_OR_OTHER||||||<|0.002||95.0|||||t-test, 2 sided|||||||<0.002
72421904|NCT00361439|144354829|SUPERIORITY_OR_OTHER||||||<|0.01||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.010
72421905|NCT00462280|144354861|SUPERIORITY_OR_OTHER|||||||0.61|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.61
72421906|NCT01313286|144354887|SUPERIORITY_OR_OTHER||Ratio of Geometric Least Square means|1.08|||||TWO_SIDED|90.0|1.0|1.16|||Mixed Models Analysis|Ratio of test formulation (HCl salt) to reference formulation (free base).||||1.16|1.00|
72421907|NCT01313286|144354888|SUPERIORITY_OR_OTHER||Ratio of Geometric Least Square means|1.18|||||TWO_SIDED|90.0|1.07|1.31|||Mixed Models Analysis|Ratio of test formulation (HCl salt) to reference formulation (free base).||||1.31|1.07|
72421908|NCT00755040|144354889|SUPERIORITY||Odds Ratio (OR)|1.11|||>|0.99|TWO_SIDED|95.0|||||Fisher Exact|||||||>0.99
72421909|NCT00733980|144354891|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.2479||||0.703||80.0|-0.5887|1.0846|||Mixed-Model Repeated-Measure analysis|||||1.0846|-0.5887|0.703
72421910|NCT00733980|144354892|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.0169||||0.966|TWO_SIDED|80.0|-0.5231|0.4893|||Mixed Models Analysis|||GSK561679 Vs Placebo, Week 1||0.4893|-0.5231|0.966
72421911|NCT00733980|144354892|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.4299||||0.386|TWO_SIDED|80.0|-0.2063|1.0661|||Mixed Models Analysis|||GSK561679 Vs Placebo, Week 2||1.0661|-0.2063|0.386
72421912|NCT00733980|144354892|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.9413||||0.095|TWO_SIDED|80.0|0.2203|1.6624|||Mixed Models Analysis|||GSK561679 Vs Placebo, Week 4||1.6624|0.2203|0.095
72421913|NCT00733980|144354893|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.9495||||0.209|TWO_SIDED|80.0|-0.0185|1.9175|||Mixed Models Analysis|||GSK561679 350 mg Vs Placebo, Week 1||1.9175|-0.0185|0.209
72421914|NCT00733980|144354893|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.7638||||0.409|TWO_SIDED|80.0|-0.4243|1.9519|||Mixed Models Analysis|||GSK561679 350 mg Vs Placebo, Week 2||1.9519|-0.4243|0.409
72421915|NCT00733980|144354893|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.5363||||0.156|TWO_SIDED|80.0|0.1485|2.9241|||Mixed Models Analysis|||GSK561679 350 mg Vs Placebo, Week 4||2.9241|0.1485|0.156
72421916|NCT00733980|144354893|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.6327||||0.599|TWO_SIDED|80.0|-0.9135|2.1789|||Mixed Models Analysis|||GSK561679 350 mg Vs Placebo, Week 6||2.1789|-0.9135|0.599
72421917|NCT00733980|144354894|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.9866||||0.181|TWO_SIDED|80.0|-3.8876|-0.0856|||Mixed Models Analysis|||GSK561679 350 mg Vs Placebo, Week 1||-0.0856|-3.8876|0.181
72330520|NCT01864148|144186536|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.66||||0.1771|TWO_SIDED|95.0|0.36|1.21|||Regression, Logistic|Odds ratios, 95% CI and p-values are based on logistic regression adjusted for MS type, region and baseline component assessments.||||1.21|0.36|0.1771
72421918|NCT00733980|144354894|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.2538||||0.889|TWO_SIDED|80.0|-2.5922|2.0846|||Mixed Models Analysis|||GSK561679 350 mg Vs Placebo, Week 2||2.0846|-2.5922|0.889
72330521|NCT01864148|144186536|SUPERIORITY_OR_OTHER|||||||0.8931|||||||Trend test|Trend test p-value is based on a linear contrast in logistic regression.||||||0.8931
72330522|NCT01864148|144186537|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.65||||0.3058|TWO_SIDED|95.0|0.28|1.49|||Regression, Logistic|Odds ratios, 95% CI and p-values are based on logistic regression adjusted for MS type, region and baseline component assessments.||||1.49|0.28|0.3058
72330523|NCT01864148|144186537|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.53||||0.1873|TWO_SIDED|95.0|0.81|2.89|||Regression, Logistic|Odds ratios, 95% CI and p-values are based on logistic regression adjusted for MS type, region and baseline component assessments.||||2.89|0.81|0.1873
72330524|NCT01864148|144186537|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.42||||0.2766|TWO_SIDED|95.0|0.76|2.65|||Regression, Logistic|Odds ratios, 95% CI and p-values are based on logistic regression adjusted for MS type, region and baseline component assessments.||||2.65|0.76|0.2766
72330525|NCT01864148|144186537|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.86||||0.6578|TWO_SIDED|95.0|0.45|1.65|||Regression, Logistic|Odds ratios, 95% CI and p-values are based on logistic regression adjusted for MS type, region and baseline component assessments.||||1.65|0.45|0.6578
72330526|NCT01864148|144186537|SUPERIORITY_OR_OTHER|||||||0.5255|||||||Trend test|Trend test p-value is based on a linear contrast in logistic regression.||||||0.5255
72330527|NCT02027311|144186540|SUPERIORITY_OR_OTHER|||||||0.05|TWO_SIDED|95.0||||For two-sided tests, p \< 0.05 was considered statistically significant.|Regression, Logistic|Logistic regression model used to identify the factors related to the presence of intervention (frequency of intervention = 0, vs. ≥ 1).||If the true difference in the experimental and control means is 4, total 26 experimental subjects and 26 control subjects was required to reject the null hypothesis that the means of the primary outcome values of experimental and control groups are equal with probability (power) 0.8. The Type I error probability associated with this test of this null hypothesis is 0.05.||||0.05
72421919|NCT00733980|144354894|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.3242||||0.867|TWO_SIDED|80.0|-2.8165|2.1681|||Mixed Models Analysis|||GSK561679 350 mg Vs Placebo, Week 3||2.1681|-2.8165|0.867
72421920|NCT00733980|144354894|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.8107||||0.721|TWO_SIDED|80.0|-2.1036|3.7251|||Mixed Models Analysis|||GSK561679 350 mg Vs Placebo, Week 4||3.7251|-2.1036|0.721
72421921|NCT00733980|144354894|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.6273||||0.801|TWO_SIDED|80.0|-3.8337|2.5791|||Mixed Models Analysis|||GSK561679 350 mg Vs Placebo, Week 6||2.5791|-3.8337|0.801
72421922|NCT00733980|144354895|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.644||||0.355|TWO_SIDED|80.0|-0.2498|1.5378|||Mixed Models Analysis|||GSK561679 350 mg Vs Placebo, Week 1||1.5378|-0.2498|0.355
72421923|NCT00733980|144354895|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.0524||||0.249|TWO_SIDED|80.0|-0.1194|2.2243|||Mixed Models Analysis|||GSK561679 350 mg Vs Placebo, Week 2||2.2243|-0.1194|0.249
72421924|NCT00733980|144354895|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.6473||||0.116|TWO_SIDED|80.0|0.3078|2.9868|||Mixed Models Analysis|||GSK561679 350 mg Vs Placebo, Week 4||2.9868|0.3078|0.116
72421925|NCT00733980|144354895|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.7283||||0.55|TWO_SIDED|80.0|-0.8353|2.292|||Mixed Models Analysis|||GSK561679 350 mg Vs Placebo, Week 6||2.2920|-0.8353|0.550
72421926|NCT00733980|144354899|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.6359||||0.3588|TWO_SIDED|80.0|0.3378|1.1968|||Logistic Model|||GSK561679 350 mg Vs Placebo, Week 2||1.1968|0.3378|0.3588
72421927|NCT00733980|144354899|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.7347||||0.4088|TWO_SIDED|80.0|0.4554|1.1853|||Logistic Model|||GSK561679 350 mg Vs Placebo, Week 4||1.1853|0.4554|0.4088
72421928|NCT00733980|144354899|SUPERIORITY_OR_OTHER||Logistic Model|0.9211||||0.8156|TWO_SIDED|80.0|0.5863|1.4471|||Logistic Model|||GSK561679 350 mg Vs Placebo, Week 6/ Early withdrawal||1.4471|0.5863|0.8156
72421929|NCT00733980|144354900|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.4466||||0.361|TWO_SIDED|80.0|-1.3986|8.2917|||ANCOVA|||||8.2917|-1.3986|0.361
72421930|NCT00733980|144354901|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.1167||||0.932|TWO_SIDED|80.0|-1.6387|1.8722|||ANCOVA|||||1.8722|-1.6387|0.932
72421931|NCT03750006|144354927|SUPERIORITY|||||||0.0238||||||Not adjusted for multiple comparisons, P \< 0.05 is considered significant.|t-test, 2 sided|paired T-test||||||0.0238
72421932|NCT03750006|144354928|SUPERIORITY|||||||0.3029|||||||t-test, 2 sided|Paired, P \< 0.05 is considered significant.||||||0.3029
72421933|NCT03750006|144354929|SUPERIORITY|||||||0.1713|||||||t-test, 2 sided|Paired, P \< 0.05 is considered significant.||||||0.1713
72421934|NCT03750006|144354930|SUPERIORITY|||||||0.1261|||||||t-test, 2 sided|paired, P \< 0.05 is considered significant.||||||0.1261
72421935|NCT03750006|144354931|SUPERIORITY|||||||0.1367|||||||t-test, 2 sided|paired, P \< 0.05 is considered significant.||||||0.1367
72421936|NCT03750006|144354932|SUPERIORITY|||||||0.0111|||||||t-test, 2 sided|paired, P \< 0.05 is considered significant.||||||0.0111
72421937|NCT03750006|144354933|SUPERIORITY|||||||0.0219|||||||t-test, 2 sided|Paired, P \< 0.05 is considered significant.||||||0.0219
72421938|NCT03750006|144354934|SUPERIORITY|||||||0.366|||||||t-test, 2 sided|Paired, P \< 0.05 considered significant.||||||0.3660
72421939|NCT03750006|144354937|SUPERIORITY|||||||0.1563|||||||t-test, 2 sided|Paired, P \< 0.05 is considered significant.||||||0.1563
72421940|NCT03750006|144354938|SUPERIORITY|||||||0.011|||||||t-test, 2 sided|Paired, P \< 0.05 is considered significant.||||||0.0110
72421941|NCT03750006|144354939|OTHER|||||||0.3282|||||||t-test, 2 sided|Paired, P \< 0.05 is considered significant.||||||0.3282
72421942|NCT03750006|144354940|SUPERIORITY|||||||0.5244|||||||t-test, 2 sided|Paired, P \< 0.05 is considered significant.||||||0.5244
72421943|NCT03750006|144354941|SUPERIORITY|||||||0.5718|||||||t-test, 2 sided|Paired, P \< 0.05 is considered significant.||||||0.5718
72421944|NCT01061333|144354987|SUPERIORITY_OR_OTHER||Difference in LS mean|16.22|||<|0.0001|TWO_SIDED|90.0|10.74|21.69||p-value not adjusted for simultaneous multiple comparisons|ANCOVA|||||21.69|10.74|<0.0001
72421945|NCT01061333|144354987|SUPERIORITY_OR_OTHER||Difference in LS Mean|15.51||||0.0001|TWO_SIDED|90.0|10.0|21.02||p-value not adjusted for simultaneous multiple comparisons|ANCOVA|||||21.02|10.00|0.0001
72421946|NCT01061333|144354987|SUPERIORITY_OR_OTHER||Difference in LS Mean|8.49||||0.0432|TWO_SIDED|90.0|1.78|15.2||p-value not adjusted for simultaneous multiple comparisons|ANCOVA|||||15.20|1.78|0.0432
72421947|NCT01061333|144354988|SUPERIORITY_OR_OTHER||Geom. Mean Ratio of fold over baseline|1.27||||0.043|TWO_SIDED|90.0|1.05|1.54||p-Value not adjusted for simultaneous multiple comparisons|ANCOVA|concentrations evaluated at log scale||||1.54|1.05|0.0430
72421948|NCT01061333|144354988|SUPERIORITY_OR_OTHER||Geom. Mean Ratio of fold over baseline|1.41||||0.01|TWO_SIDED|90.0|1.15|1.72||p-Value not adjusted for simultaneous multiple comparisons|ANCOVA|concentrations evaluated at log scale||||1.72|1.15|0.0100
72421949|NCT01061333|144354988|SUPERIORITY_OR_OTHER||Geom. Mean Ratio of fold over baseline|1.3||||0.086|TWO_SIDED|90.0|1.01|1.67||p-Value not adjusted for simultaneous multiple comparisons|ANCOVA|concentrations evaluated at log scale||||1.67|1.01|0.0860
72421950|NCT01061333|144354989|SUPERIORITY_OR_OTHER||Geom. Mean Ratio of fold over baseline|0.59|||<|0.0001|TWO_SIDED|90.0|0.5|0.7||p-Value not adjusted for simultaneous multiple comparisons|ANCOVA|concentrations evaluated at log scale||||0.70|0.50|<0.0001
72421951|NCT01061333|144354989|SUPERIORITY_OR_OTHER||Geom. Mean Ratio of fold over baseline|0.59|||<|0.0001|TWO_SIDED|90.0|0.49|0.7||p-Value not adjusted for simultaneous multiple comparisons|ANCOVA|concentrations evaluated at log scale||||0.70|0.49|<0.0001
72421952|NCT01061333|144354989|SUPERIORITY_OR_OTHER||Geom. Mean Ratio of fold over baseline|0.87||||0.2679|TWO_SIDED|90.0|0.69|1.08||p-Value not adjusted for simultaneous multiple comparisons|ANCOVA|concentrations evaluated at log scale||||1.08|0.69|0.2679
72421953|NCT01061333|144354990|SUPERIORITY_OR_OTHER||Geom. Mean Ratio of fold over baseline|0.9||||0.7622|TWO_SIDED|90.0|0.51|1.59||p-Value not adjusted for simultaneous multiple comparisons|ANCOVA|concentrations evaluated at log scale||||1.59|0.51|0.7622
72421954|NCT01061333|144354990|SUPERIORITY_OR_OTHER||Geom. Mean Ratio of fold over baseline|0.94||||0.8468|TWO_SIDED|90.0|0.53|1.65||p-Value not adjusted for simultaneous multiple comparisons|ANCOVA|concentrations evaluated on log scale||||1.65|0.53|0.8468
72421955|NCT01061333|144354990|SUPERIORITY_OR_OTHER||Geom. Mean Ratio of fold over baseline|0.91||||0.614|TWO_SIDED|90.0|0.65|1.26||p-Value not adjusted for simultaneous multiple comparisons|ANCOVA|concentrations evaluated at log scale||||1.26|0.65|0.6140
72421956|NCT01061333|144354991|SUPERIORITY_OR_OTHER||Geom. Mean Ratio of fold over baseline|0.67||||0.0006|TWO_SIDED|90.0|0.57|0.8||p-Value not adjusted for simultaneous multiple comparisons|ANCOVA|concentrations evaluated at log scale||||0.80|0.57|0.0006
72421957|NCT01061333|144354991|SUPERIORITY_OR_OTHER||Geom. Mean Ratio of fold over baseline|0.79||||0.0291|TWO_SIDED|90.0|0.67|0.94||p-Value not adjusted for simultaneous multiple comparisons|ANCOVA|concentrations evaluated at log scale||||0.94|0.67|0.0291
72330528|NCT02027311|144186541|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|11.09||||0.002|TWO_SIDED|95.0|2.41|50.94||Logistic regression model were used in univariate and corrected multivariate analyses to identify the factors related to the primary outcome variables, such as, presence of intervention (frequency of intervention = 0, vs. ≥ 1).|Regression, Logistic|||All the continuous variables were compared using the Mann-Whitney U test and dichotomous categorical variables was used and the Pearson chi-square with Fisher exact test. We used the linear mixed model to compare the differences of paired data, such as mean values of RR, SpO2, MAP, HR, and RSS at different time points of the two different sedation groups. For two-sided tests, p \< 0.05 was considered statistically significant.||50.94|2.41|0.002
72330529|NCT01825512|144186542|NON_INFERIORITY|Deferiprone was declared non inferior to Deferasirox if the lower limit of the 95% confidence interval for the difference in the proportion of successful chelation in the two groups is above -12.5%.|Treatment success rate|-12.5|||||ONE_SIDED|95.0|-12.5||||||||||-12.5|
72330530|NCT01825512|144186543|OTHER|GLM model|Mean Difference (Final Values)|2.128|STANDARD_ERROR_OF_MEAN|1.18||0.074|TWO_SIDED|95.0|-0.213|4.468|||ANCOVA|||||4.468|-0.213|0.074
72330531|NCT01825512|144186544|OTHER|GLM Analysis|Mean Difference (Final Values)|-0.633|STANDARD_ERROR_OF_MEAN|1.741||0.717|TWO_SIDED|95.0|-4.085|2.819|||ANCOVA|||||2.819|-4.085|0.717
72330532|NCT01825512|144186545|NON_INFERIORITY|Non inferiority of Deferiprone to Deferasirox is tested considering a non-inferiority margin of 400 ng/mL.|Mean Difference (Final Values)|0.601|STANDARD_ERROR_OF_MEAN|164.734||0.997|TWO_SIDED|95.0|-323.58|324.781|||GLM|||||324.781|-323.580|0.997
72330533|NCT02466425|144186546|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-9.9|STANDARD_ERROR_OF_MEAN|1.59|<|0.001|TWO_SIDED|95.0|-13.0|-6.8|||Mixed-effects model for repeated measure||Between treatment groups|||-6.8|-13.0|<0.001
72330534|NCT03231917|144186572|OTHER|||||||0.48|||||||Chi-squared|||||||0.48
72330535|NCT01901289|144186589|OTHER||Cumulative Probability|0.927|STANDARD_ERROR_OF_MEAN|0.019|||TWO_SIDED|95.0|0.881|0.956|||||The estimate of the variance of the Kaplan-Meier estimate used the methods described by Peto et al.|||0.956|0.881|
72330536|NCT01813058|144186590|SUPERIORITY||Mean Difference (Final Values)|195.0|||<|0.001|TWO_SIDED||||||Fisher Exact|||||||<0.001
72330537|NCT00182078|144186599|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.8|STANDARD_DEVIATION|3.4|=|0.017|TWO_SIDED|95.0|||||t-test, 2 sided|||||||=0.017
72330538|NCT00182078|144186600|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.1|STANDARD_DEVIATION|3.9|<|0.001|TWO_SIDED|95.0|||||t-test, 2 sided|||||||<0.001
72330539|NCT00182078|144186601|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.9|STANDARD_DEVIATION|4.4|=|0.65|TWO_SIDED|95.0|||||t-test, 2 sided|||||||=0.65
72330540|NCT01153711|144186602|NON_INFERIORITY_OR_EQUIVALENCE|Relative bioavailability|Adjusted geometric mean ratio|168.4|STANDARD_DEVIATION|16.4||1|TWO_SIDED|90.0|155.5|182.4||P-value for ratio outside interval 0.8-1.25|ANOVA|Adjusted geometric mean ratio|The standard deviation is actually the geometric coefficient of variation|Ratio Olodaterol plus Ketoconazole and Olodaterol||182.4|155.5|1.0000
72330541|NCT01153711|144186603|NON_INFERIORITY_OR_EQUIVALENCE|Relative bioavailability|Adjusted geometric mean ratio|166.1|STANDARD_DEVIATION|16.8||1|TWO_SIDED|90.0|153.6|179.6||P-value for ratio outside 0.8-1.25|ANOVA|Adjusted geometric mean ratio|The standard deviation is actually the geometric coefficient of variation|Ratio Olodaterol plus Ketoconazole and Olodaterol for the category Olodaterol||179.6|153.6|1.0000
72330542|NCT01153711|144186603|NON_INFERIORITY_OR_EQUIVALENCE|Relative bioavailability|Adjusted geometric mean ratio|106.63|STANDARD_DEVIATION|14.7||0.0001|TWO_SIDED|90.0|100.211|113.463||P-value for ratio outside 0.8-1.25|ANOVA|Adjusted geometric mean ratio|The standard deviation is actually the geometric coefficient of variation|Ratio Olodaterol plus Ketoconazole and Olodaterol for the category Olodaterol glucuronide||113.463|100.211|0.0001
72330543|NCT01153711|144186606|NON_INFERIORITY_OR_EQUIVALENCE|Relative bioavailability|Adjusted geometric mean ratio|144.23|STANDARD_DEVIATION|17.8||0.9986|TWO_SIDED|90.0|133.853|155.417||P-value for ratio outside 0.8-1.25|ANOVA|Adjusted geometric mean ratio|The standard deviation is actually the geometric coefficient of variation|Ratio Olodaterol plus Ketoconazole and Olodaterol for the category Olodaterol||155.417|133.853|0.9986
72330544|NCT01153711|144186606|NON_INFERIORITY_OR_EQUIVALENCE|Relative bioavailability|Adjusted geometric mean ratio|132.87|STANDARD_DEVIATION|18.9||0.8991|TWO_SIDED|90.0|122.732|143.843||P-value for ratio outside 0.8-1.25|ANOVA|Adjusted geometric mean ratio|The standard deviation is actually the geometric coefficient of variation|Ratio Olodaterol plus Ketoconazole and Olodaterol for the category Olodaterol glucuronide||143.843|122.732|0.8991
72421958|NCT01061333|144354991|SUPERIORITY_OR_OTHER||Geom. Mean Ratio of fold over baseline|0.92||||0.3738|TWO_SIDED|90.0|0.77|1.08||p-Value not adjusted for simultaneous multiple comparisons|ANCOVA|concentrations evaluated at log scale||||1.08|0.77|0.3738
72421959|NCT01061333|144354992|SUPERIORITY_OR_OTHER||Geom. mean of fold change over Placebo|1.03||||0.7501||90.0|0.88|1.2||p-Value not adjusted for simultaneous multiple comparisons|ANOVA|concentrations evaluated at log scale||||1.20|0.88|0.7501
72421960|NCT01061333|144354992|SUPERIORITY_OR_OTHER||Geom. mean of fold change over Placebo|1.01||||0.941|TWO_SIDED|90.0|0.81|1.25||p-Value not adjusted for simultaneous multiple comparisons|ANOVA|concentrations evaluated at log scale||||1.25|0.81|0.9410
72421961|NCT01061333|144354992|SUPERIORITY_OR_OTHER||Geom. mean of fold change over Placebo|0.89||||0.1165|TWO_SIDED|90.0|0.79|1.01||p-Value not adjusted for simultaneous multiple comparisons|ANOVA|concentrations evaluated at log scale||||1.01|0.79|0.1165
72421962|NCT01061333|144354993|SUPERIORITY_OR_OTHER||Geom. mean of fold change over Placebo|1.03||||0.8616|TWO_SIDED|90.0|0.76|1.41||p-Value not adjusted for simultaneous multiple comparisons|ANOVA|concentrations evaluated at log scale||||1.41|0.76|0.8616
72421963|NCT01061333|144354993|SUPERIORITY_OR_OTHER||Geom. mean of fold change over Placebo|1.06||||0.7512|TWO_SIDED|90.0|0.77|1.45||p-Value not adjusted for simultaneous multiple comparisons|ANOVA|concentrations evaluated at log scale||||1.45|0.77|0.7512
72421964|NCT01061333|144354993|SUPERIORITY_OR_OTHER||Geom. mean of fold change over Placebo|0.99||||0.9723|TWO_SIDED|90.0|0.72|1.37||p-Value not adjusted for simultaneous multiple comparisons|ANOVA|concentrations evaluated at log scale||||1.37|0.72|0.9723
72421965|NCT01061333|144354994|SUPERIORITY_OR_OTHER||Geom. mean of fold change over Placebo|1.3||||0.1983|TWO_SIDED|90.0|0.92|1.82||p-Value not adjusted for simultaneous multiple comparisons|ANOVA|concentrations evaluated at log scale||||1.82|0.92|0.1983
72421966|NCT01061333|144354994|SUPERIORITY_OR_OTHER||Geom. mean of fold change over Placebo|1.57||||0.0872|TWO_SIDED|90.0|1.02|2.42||p-Value not adjusted for simultaneous multiple comparisons|ANOVA|concentrations evaluated at log scale||||2.42|1.02|0.0872
72421967|NCT01061333|144354994|SUPERIORITY_OR_OTHER||Geom. mean of fold change over Placebo|1.22||||0.2499|TWO_SIDED|90.0|0.91|1.62||p-Value not adjusted for simultaneous multiple comparisons|ANOVA|concentrations evaluated at log scale||||1.62|0.91|0.2499
72421968|NCT01782742|144355034|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.05||||0.22|TWO_SIDED|95.0|-0.13|0.03|||t-test, 2 sided|||||0.03|-0.13|0.22
72421969|NCT01782742|144355035|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0||||0.57|TWO_SIDED|95.0|-4.428|2.428|||t-test, 2 sided|||||2.428|-4.428|0.57
72421970|NCT01782742|144355036|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.625||||0.83|TWO_SIDED|95.0|-5.029|6.279|||t-test, 2 sided|||||6.279|-5.029|0.83
72421971|NCT01782742|144355037|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|||||TWO_SIDED|95.0|0.0|0.0||||||||0.000|0.000|
72421972|NCT01782742|144355038|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.375||||0.94|TWO_SIDED|95.0|-9.674|8.924|||t-test, 2 sided|||||8.924|-9.674|0.94
72421973|NCT01782742|144355039|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.563||||0.18|TWO_SIDED|95.0|-1.975|11.1|||t-test, 2 sided|||||11.100|-1.975|0.18
72421974|NCT01782742|144355047|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.006||||0.46|TWO_SIDED|95.0|-0.01|0.021|||t-test, 2 sided|||||0.021|-0.010|0.46
72421975|NCT01782742|144355048|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01||||0.53|TWO_SIDED|95.0|-0.02|0.04|||t-test, 2 sided|||||0.040|-0.020|0.53
72553870|NCT05342597|144639789|OTHER|Estimated difference in least squares means and corresponding 90%CI of log-transformed PK parameters were back transformed to obtain the estimate and CI of the geometric mean ratio of each meal condition to the fasted state.|LS Mean Ratio|0.872|||||TWO_SIDED|90.0|0.661|1.15|||ANOVA|||PK parameters of unchanged edaravone were analyzed for the assessments of food effect on PK.||1.150|0.661|
72330545|NCT01153711|144186607|NON_INFERIORITY_OR_EQUIVALENCE|Relative bioavailability|Adjusted geometric mean ratio|100.75|STANDARD_DEVIATION|17.9||0.0001|TWO_SIDED|90.0|92.534|109.692||P-value for ratio outside interval 0.8-1.25|ANOVA|Adjusted geometric mean ratio|The standard deviation is actually the geometric coefficient of variation|Ratio Olodaterol plus Ketoconazole and Olodaterol||109.692|92.534|0.0001
72421976|NCT02305381|144355050|SUPERIORITY_OR_OTHER||Treatment difference|-1.75|||<|0.0001|TWO_SIDED|95.0|-2.01|-1.5|||Mixed Models Analysis||Superiority for change in HbA1c was claimed if the upper limit of the 2-sided 95% CI for the estimated difference was below 0%.|Hierarchical testing was performed as per sequence listed below:Change in HbA1c: semaglutide 1.0 mg vs placebo. Change in HbA1c: semaglutide 0.5 mg vs placebo. Change in body weight: semaglutide 1.0 mg vs placebo. Change in body weight: semaglutide 0.5 mg vs placebo. Analysis was performed using MMRM with treatment, country and stratification variable (HbA1c at screening \[≤8.0% or \>8.0%\] crossed with use of metformin \[yes or no\]; 2 by 2 levels) as fixed factors and baseline value as covariate||-1.50|-2.01|< 0.0001
72421977|NCT02305381|144355050|SUPERIORITY_OR_OTHER||Treatment difference|-1.35|||<|0.0001|TWO_SIDED|95.0|-1.61|-1.1|||Mixed Models Analysis||Superiority for change in HbA1c was claimed if the upper limit of the 2-sided 95% CI for the estimated difference was below 0%.|Hierarchical testing was performed as per sequence listed below:Change in HbA1c: semaglutide 1.0 mg vs placebo. Change in HbA1c: semaglutide 0.5 mg vs placebo. Change in body weight: semaglutide 1.0 mg vs placebo. Change in body weight: semaglutide 0.5 mg vs placebo. Analysis was performed using MMRM with treatment, country and stratification variable (HbA1c at screening \[≤8.0% or \>8.0%\] crossed with use of metformin \[yes or no\]; 2 by 2 levels) as fixed factors and baseline value as covariate||-1.10|-1.61|< 0.0001
72421978|NCT02487498|144355066|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was demonstrated if the lower limit (LL) of the 97.5% one -sided confidence interval (CI) \> -20 mL|Mean Difference (Net)|-0.0182|STANDARD_ERROR_OF_MEAN|0.00813||0.415|TWO_SIDED|95.0|-0.0342|-0.0023|||Linear Mixed Model|||Ho: QVA149 27.5/12.5 μg b.i.d. is inferior to umeclidinium/vilanterol 62.5/25 μg q.d; Ha: QVA149 27.5/12.5 μg b.i.d. is non-inferior to umeclidinium/vilanterol 62.5/25 μg q.d.||-0.0023|-0.0342|0.415
72421979|NCT02487498|144355067|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.0182|STANDARD_ERROR_OF_MEAN|0.00813|||TWO_SIDED|95.0|-0.0342|-0.0023||||||||-0.0023|-0.0342|
72421980|NCT02487498|144355068|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.0091|STANDARD_ERROR_OF_MEAN|0.01132|||TWO_SIDED|95.0|-0.0313|0.0131||||||||0.0131|-0.0313|
72421981|NCT02487498|144355069|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0086|STANDARD_ERROR_OF_MEAN|0.00874|||TWO_SIDED|95.0|-0.0086|0.0258||||||||0.0258|-0.0086|
72421982|NCT00676130|144355075|SUPERIORITY_OR_OTHER||Risk Difference (RD)|2.7|||<|0.05||95.0|-9.3|15.0|||Chi-squared|||The study was powered to detect a difference in cure rate of 98% in the intervention group vs. 85% in the control group, with 2-sided alpha 0.05. This would yield a number needed to treat of 7.7 for intervention vs. control, and required 144 subjects to achieve 80% power. No data were analyzed until study completion.||15|-9.3|<0.05
72330546|NCT01606176|144186610|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-0.39||||0.332|TWO_SIDED|95.0|-1.18|0.4|||ANCOVA|||"The change was compared between treatment groups using analysis of covariance (ANCOVA). The significance of the treatment effect, after adjusting for baseline pain score, was assessed using the F-test from the ANCOVA. The model was as follows:~Change in Box Scale-11 Pain Score = Baseline Pain Score + Treatment"||0.40|-1.18|0.332
72330547|NCT01606176|144186611|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-29.55||||0.002|TWO_SIDED|95.0|-48.08|-11.02|||ANOVA|||The proportions were compared between treatment groups using analysis of variance (ANOVA) with treatment as a factor.||-11.02|-48.08|0.002
72330548|NCT01606176|144186612|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-0.34||||0.052|TWO_SIDED|95.0|-0.68|0.0|||ANCOVA|||"The change was compared between treatment groups using ANCOVA. The significance of the treatment effect, after adjusting for baseline sleep disturbance score, was assessed using the F-test from the ANCOVA. The model was as follows:~Change in Sleep Disturbance Score = Baseline Sleep Disturbance Score + Treatment"||0.00|-0.68|0.052
72330549|NCT01606176|144186613|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.79||||0.3|TWO_SIDED|95.0|-8.14|2.56|||ANCOVA|||"The change was compared between treatment groups using ANCOVA. The significance of the treatment effect, after adjusting for baseline Pain Disability Index score, was assessed using the F-test from the ANCOVA. The model was as follows:~Change in Pain Disability Index Score = Baseline Pain Disability Index Score + Treatment"||2.56|-8.14|0.300
72330550|NCT01606176|144186614|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-1.66||||0.233|TWO_SIDED|95.0|-4.42|1.1|||ANCOVA|||"The change was compared between treatment groups using ANCOVA. The significance of the treatment effect, after adjusting for baseline Total Brief Pain Inventory (Short Form) score, was assessed using the F-test from the ANCOVA. The model was as follows:~Change in Total Brief Pain Inventory (Short Form) Score = Baseline Total Brief Pain Inventory (Short Form) Score + Treatment"||1.10|-4.42|0.233
72330551|NCT01606176|144186615|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|0.28||||0.387|TWO_SIDED|95.0|-0.36|0.91|||ANCOVA|||"The change was compared between treatment groups using ANCOVA. The significance of the treatment effect, after adjusting for baseline Total Spitzer Quality of Life Index score, was assessed using the F-test from the ANCOVA. The model was as follows:~Change in Total Spitzer Quality of Life Index Score = Baseline Total Spitzer Quality of Life Index Score + Treatment"||0.91|-0.36|0.387
72330552|NCT01606176|144186616|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-1.47||||1|TWO_SIDED|95.0|-21.56|18.51|||Fisher Exact|||"The proportion of patients who considered their condition Very Much Improved or Much Improved was compared between treatment groups using a Fisher's Exact Test."||18.51|-21.56|1.000
72330553|NCT01606176|144186617|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-0.86||||0.128|TWO_SIDED|95.0|-1.97|0.26|||ANCOVA|||"The change was compared between treatment groups using analysis of covariance (ANCOVA). The significance of the treatment effect, after adjusting for baseline pain score, was assessed using the F-test from the ANCOVA. The model was as follows:~Change in Box Scale-11 Pain Score = Baseline Pain Score + Treatment"||0.26|-1.97|0.128
72330554|NCT01606176|144186618|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-31.77||||0.009|TWO_SIDED|95.0|-55.07|-8.47|||ANOVA|||The proportions were compared between treatment groups using ANOVA with treatment as a factor.||-8.47|-55.07|0.009
72330555|NCT01606176|144186619|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-0.32||||0.184|TWO_SIDED|95.0|-0.8|0.16|||ANCOVA|||"The change was compared between treatment groups using ANCOVA. The significance of the treatment effect, after adjusting for baseline sleep disturbance score, was assessed using the F-test from the ANCOVA. The model was as follows:~Change in Sleep Disturbance Score = Baseline Sleep Disturbance Score + Treatment"||0.16|-0.80|0.184
72330556|NCT01606176|144186620|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-5.18||||0.134|TWO_SIDED|95.0|-12.05|1.68|||ANCOVA|||"The change was compared between treatment groups using ANCOVA. The significance of the treatment effect, after adjusting for baseline Pain Disability Index score, was assessed using the F-test from the ANCOVA. The model was as follows:~Change in Pain Disability Index Score = Baseline Pain Disability Index Score + Treatment"||1.68|-12.05|0.134
72330557|NCT01606176|144186621|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-3.77||||0.031|TWO_SIDED|95.0|-7.17|-0.36|||ANCOVA|||"The change was compared between treatment groups using ANCOVA. The significance of the treatment effect, after adjusting for baseline Total Brief Pain Inventory (Short Form) score, was assessed using the F-test from the ANCOVA. The model was as follows:~Change in Total Brief Pain Inventory (Short Form) Score = Baseline Total Brief Pain Inventory (Short Form) Score + Treatment"||-0.36|-7.17|0.031
72330558|NCT01606176|144186622|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|0.04||||0.915|TWO_SIDED|95.0|-0.79|0.88|||ANCOVA|||"The change was compared between treatment groups using ANCOVA. The significance of the treatment effect, after adjusting for baseline Total Spitzer Quality of Life Index score, was assessed using the F-test from the ANCOVA. The model was as follows:~Change in Total Spitzer Quality of Life Index Score = Baseline Total Spitzer Quality of Life Index Score + Treatment"||0.88|-0.79|0.915
72421983|NCT00676130|144355076|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.0|||<|0.05|TWO_SIDED|95.0|-6.5|6.3|||Chi-squared|||We assessed the rate of progression to abscess in the two groups.||6.3|-6.5|<0.05
72421984|NCT00755222|144355109|SUPERIORITY_OR_OTHER|||||||0.001|||||||ANOVA|||||||0.001
72421985|NCT00755222|144355110|SUPERIORITY_OR_OTHER|||||||0.046||95.0|||||ANOVA|||||||0.046
72421986|NCT00755222|144355111|SUPERIORITY_OR_OTHER|||||||0.164|||||||ANOVA|||||||0.164
72421987|NCT00755222|144355112|SUPERIORITY_OR_OTHER|||||||0.442|||||||ANOVA|||||||0.442
72421988|NCT00755222|144355113|SUPERIORITY_OR_OTHER|||||||0.095|||||||ANOVA|||||||0.095
72421989|NCT04382924|144355126|SUPERIORITY||Odds Ratio, log|0.0001|||<|0.025|TWO_SIDED||||||Chi-squared|||||||<0.025
72330559|NCT01606176|144186623|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|3.95||||1|TWO_SIDED|95.0|-21.85|27.47|||Fisher Exact|||"The proportion of patients who considered their condition Very Much Improved or Much Improved was compared between treatment groups using a Fisher's Exact Test."||27.47|-21.85|1.00
72330560|NCT01732510|144186659|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.82||||0.015|TWO_SIDED|95.0|-16.87|-2.77|||Constrained longitudinal data analysis|||The reduction from baseline in EASI at week 12 for participants receiving MK-8226 3 mg/kg was compared to placebo (MK-8226 3 mg - Placebo). The constrained longitudinal data analysis model used variance component covariance matrix to model correlation among repeated visits, without adjustment for interaction of treatment group by visit.||-2.77|-16.87|0.015
72330561|NCT00313144|144186679|SUPERIORITY_OR_OTHER_LEGACY|||||||0.044||95.0|||||Paired t-test|||||||0.044
72330562|NCT00313144|144186681|SUPERIORITY_OR_OTHER_LEGACY|||||||0.009||95.0|||||Paired t-test|||||||0.009
72330563|NCT00313144|144186682|SUPERIORITY_OR_OTHER_LEGACY|||||||0.005||95.0|||||Paired t-test|||||||0.005
72330564|NCT00313144|144186684|SUPERIORITY_OR_OTHER_LEGACY|||||||0.006||95.0|||||Paired t-test|||||||0.006
72330565|NCT00313144|144186685|SUPERIORITY_OR_OTHER_LEGACY|||||||0.044||95.0|||||Paired t-test|||||||0.044
72421990|NCT01559454|144355138|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|35.4167||||0.097|TWO_SIDED|95.0|-8.7519|79.5852|||t-test, 2 sided|||||79.5852|-8.7519|0.097
72330566|NCT00313144|144186686|SUPERIORITY_OR_OTHER_LEGACY|||||||0.046||95.0|||||Paired t-test|||||||0.046
72330567|NCT01178944|144186706|OTHER||Mean Difference (Final Values)|1.08||||0.585|TWO_SIDED|95.0|0.78|1.38|||t-test, 2 sided|||Comparison is CR+PR vs stable disease/progression||1.38|0.78|0.585
72421991|NCT01559454|144355139|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.5||||1|TWO_SIDED|95.0|0.0713|1.8248|||Fisher Exact|||||1.8248|0.0713|1.00
72330568|NCT00893152|144186707|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Chi-squared|||||||<0.05
72330569|NCT03594747|144186725|SUPERIORITY||Hazard Ratio (HR)|0.52||||0.0001|TWO_SIDED|95.0|0.37|0.74|||One-sided stratified log-rank test|||||0.74|0.37|0.0001
72330570|NCT03594747|144186725|SUPERIORITY||Hazard Ratio (HR)|0.47|||<|0.0001|TWO_SIDED|95.0|0.33|0.67|||One-sided stratified log-rank test|||||0.67|0.33|<0.0001
72330571|NCT03594747|144186726|SUPERIORITY||Hazard Ratio (HR)|0.45|||||TWO_SIDED|95.0|0.32|0.61||||||||0.61|0.32|
72330572|NCT03594747|144186726|SUPERIORITY||Hazard Ratio (HR)|0.42|||||TWO_SIDED|95.0|0.3|0.59||||||||0.59|0.30|
72330573|NCT03206918|144186772|SUPERIORITY||2-side Clopper-Pearson|87.9|||<|0.0001|TWO_SIDED|95.0|79.4|93.81|||Exact Binomial Test|The null hypothesis is ORR = 32%||||93.81|79.40|<0.0001
72368877|NCT03284307|144247453|SUPERIORITY||Slope|0.166|STANDARD_ERROR_OF_MEAN|0.12||0.174|TWO_SIDED|||||Statistical significance defined by p \< 0.05.|Mixed Models Analysis||Estimate is a slope from a linear mixed effects model representing the difference in occipital delta power between unconsciousness and disconnected consciousness after adjusting for within-subject effects.|Propofol, Unconsciousness vs Disconnected Consciousness||||0.174
72421992|NCT01559454|144355140|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|15.55075||||0.348|TWO_SIDED|95.0|-20.37051|51.34968|||t-test, 2 sided|||||51.34968|-20.37051|0.348
72421993|NCT01559454|144355141|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|39.5833||||0.088|TWO_SIDED|95.0|-7.9653|87.132|||t-test, 2 sided|||||87.1320|-7.9653|0.088
72368878|NCT03284307|144247453|SUPERIORITY||Slope|0.052|STANDARD_ERROR_OF_MEAN|0.111||0.64|TWO_SIDED|||||Statistical significance defined by p \< 0.05.|Mixed Models Analysis||Estimate is a slope from a linear mixed effects model representing the difference in occipital delta power between unconsciousness and disconnected consciousness after adjusting for within-subject effects.|Sleep, Unconsciousness vs Disconnected Consciousness||||0.640
72368879|NCT03284307|144247455|SUPERIORITY|||||||0.134||||||Statistical significance defined by p \< 0.05.|t-test, 2 sided|3 degrees of freedom||NIH Toolbox Card Sorting Score||||0.134
72421994|NCT01559454|144355142|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|12.1499||||0.895|TWO_SIDED|95.0|-30.3965|27.0632|||t-test, 2 sided|||||27.0632|-30.3965|0.895
72421995|NCT01559454|144355143|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.6||||0.6999|TWO_SIDED|95.0|0.127|2.8352|||Fisher Exact|||||2.8352|0.127|0.6999
72421996|NCT01083654|144355144|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.56||||0.262|TWO_SIDED|95.0|0.2|1.55|||Regression, Logistic|||||1.55|0.20|.262
72330574|NCT03823287|144186778|NON_INFERIORITY|If the lower bound of a two-sided 95.03% confidence interval (CI) for the difference in adjusted means of the two treatments (faricimab minus aflibercept) is greater than -4 letters (the non-inferiority margin), then faricimab is considered non-inferior to aflibercept.|Adjusted mean difference|0.7|STANDARD_ERROR_OF_MEAN|0.91|||TWO_SIDED|95.0|-1.1|2.5|||||The treatment difference in adjusted means of change from baseline BCVA is the calculated difference of Arm A: Faricimab and Arm B: Aflibercept. MMRM adjustments are listed in the outcome measure description.|The null hypothesis, H0: μ(faricimab) - μ(aflibercept) ≤-4 letters; the alternative hypothesis, Ha: μ(faricimab) - μ(aflibercept) \>-4 letters. A sample size of approximately 320 participants in each arm provided greater than 90% power to show non-inferiority of faricimab to aflibercept in the change from baseline BCVA averaged over Weeks 40, 44, and 48 in the ITT population, using a non-inferiority margin of 4 letters at the one-sided 0.02485 significance level.||2.5|-1.1|
72330575|NCT03823287|144186779|OTHER||Adjusted mean difference|0.7|STANDARD_ERROR_OF_MEAN|0.99|||TWO_SIDED|95.0|-1.2|2.7|||||The treatment difference in adjusted means of change from baseline BCVA is the calculated difference of Arm A: Faricimab and Arm B: Aflibercept. MMRM adjustments are listed in the outcome measure description.|Treatment Difference in Adjusted Means at Weeks 52-60||2.7|-1.2|
72330576|NCT03823287|144186781|OTHER||Difference in CMH Weighted Percentage|4.3|||||TWO_SIDED|95.0|-1.6|10.1|||||The treatment difference in CMH weighted percentage of participants gaining ≥15 letters is the calculated difference of Arm A: Faricimab and Arm B: Aflibercept.|Gaining ≥15 Letters: Treatment Difference at Weeks 40-48||10.1|-1.6|
72330577|NCT03823287|144186781|OTHER||Difference in CMH Weighted Percentage|5.4|||||TWO_SIDED|95.0|-2.0|12.7|||||The treatment difference in CMH weighted percentage of participants gaining ≥10 letters is the calculated difference of Arm A: Faricimab and Arm B: Aflibercept.|Gaining ≥10 Letters: Treatment Difference at Weeks 40-48||12.7|-2.0|
72330578|NCT03823287|144186781|OTHER||Difference in CMH Weighted Percentage|1.2|||||TWO_SIDED|95.0|-6.6|8.9|||||The treatment difference in CMH weighted percentage of participants gaining ≥5 letters is the calculated difference of Arm A: Faricimab and Arm B: Aflibercept.|Gaining ≥5 Letters: Treatment Difference at Weeks 40-48||8.9|-6.6|
72330579|NCT03823287|144186781|OTHER||Difference in CMH Weighted Percentage|-1.2|||||TWO_SIDED|95.0|-7.9|5.4|||||The treatment difference in CMH weighted percentage of participants gaining ≥0 letters is the calculated difference of Arm A: Faricimab and Arm B: Aflibercept.|Gaining ≥0 Letters: Treatment Difference at Weeks 40-48||5.4|-7.9|
72330580|NCT03823287|144186782|OTHER||Difference in CMH Weighted Percentage|2.7|||||TWO_SIDED|95.0|-3.2|8.5|||||The treatment difference in CMH weighted percentage of participants gaining ≥15 letters is the calculated difference of Arm A: Faricimab and Arm B: Aflibercept.|Treatment Difference in CMH Weighted Percentages at Weeks 52-60||8.5|-3.2|
72330581|NCT03823287|144186787|OTHER||Difference in CMH Weighted Percentage|1.3|||||TWO_SIDED|95.0|-2.2|4.8|||||The treatment difference in CMH weighted percentage of participants avoiding a loss of ≥15 letters is the calculated difference of Arm A: Faricimab and Arm B: Aflibercept.|Avoiding a Loss of ≥15 Letters: Treatment Difference at Weeks 40-48||4.8|-2.2|
72330582|NCT03823287|144186787|OTHER||Difference in CMH Weighted Percentage|-0.4|||||TWO_SIDED|95.0|-4.6|3.9|||||The treatment difference in CMH weighted percentage of participants avoiding a loss of ≥10 letters is the calculated difference of Arm A: Faricimab and Arm B: Aflibercept.|Avoiding a Loss of ≥10 Letters: Treatment Difference at Weeks 40-48||3.9|-4.6|
72330583|NCT03823287|144186787|OTHER||Difference in CMH Weighted Percentage|1.2|||||TWO_SIDED|95.0|-4.0|6.4|||||The treatment difference in CMH weighted percentage of participants avoiding a loss of ≥5 letters is the calculated difference of Arm A: Faricimab and Arm B: Aflibercept.|Avoiding a Loss of ≥5 Letters: Treatment Difference at Weeks 40-48||6.4|-4.0|
72330584|NCT03823287|144186788|OTHER||Difference in CMH Weighted Percentage|-0.2|||||TWO_SIDED|95.0|-3.9|3.6|||||The treatment difference in CMH weighted percentage of participants avoiding a loss of ≥15 letters is the calculated difference of Arm A: Faricimab and Arm B: Aflibercept.|Treatment Difference in CMH Weighted Percentages at Weeks 52-60||3.6|-3.9|
72330585|NCT03823287|144186792|OTHER||Difference in CMH Weighted Percentage|3.0|||||TWO_SIDED|95.0|-3.6|9.5|||||The treatment difference in CMH weighted percentage of participants gaining ≥15 letters or achieving BCVA ≥84 letters is the calculated difference of Arm A: Faricimab and Arm B: Aflibercept.|Treatment Difference in CMH Weighted Percentages at Weeks 40-48||9.5|-3.6|
72421997|NCT00991341|144355147|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.17||||0.44|TWO_SIDED|95.0|-0.6|0.26|||ANCOVA|The treatment groups were compared with respect to the change in MODS, adjusting for baseline MODS.|The longer storage red blood cell units arm is the reference category. After adjusting for baseline MODS, the difference in the means was -0.17, positive values are in favor of longer storage duration.|||0.26|-0.60|0.44
72330586|NCT03823287|144186794|OTHER||Difference in CMH Weighted Percentage|-0.5|||||TWO_SIDED|95.0|-7.7|6.6|||||The treatment difference in CMH weighted percentage of participants achieving BCVA ≥69 letters is the calculated difference of Arm A: Faricimab and Arm B: Aflibercept.|Treatment Difference in CMH Weighted Percentages at Weeks 40-48||6.6|-7.7|
72330587|NCT03823287|144186796|OTHER||Difference in CMH Weighted Percentage|-0.5|||||TWO_SIDED|95.0|-4.2|3.3|||||The treatment difference in CMH weighted percentage of participants with BCVA ≤38 letters is the calculated difference of Arm A: Faricimab and Arm B: Aflibercept.|Treatment Difference in CMH Weighted Percentages at Weeks 40-48||3.3|-4.2|
72330588|NCT03823287|144186804|OTHER||Adjusted mean difference|-7.4|STANDARD_ERROR_OF_MEAN|4.19|||TWO_SIDED|95.0|-15.7|0.8|||||The treatment difference in adjusted means of change from baseline CST is the calculated difference of Arm A: Faricimab and Arm B: Aflibercept. MMRM adjustments are listed in the outcome measure description.|Treatment Difference in Adjusted Means at Weeks 40-48||0.8|-15.7|
72330589|NCT03823287|144186805|OTHER||Adjusted mean difference|1.0|STANDARD_ERROR_OF_MEAN|4.26|||TWO_SIDED|95.0|-7.4|9.4|||||The treatment difference in adjusted means of change from baseline CST is the calculated difference of Arm A: Faricimab and Arm B: Aflibercept. MMRM adjustments are listed in the outcome measure description.|Treatment Difference in Adjusted Means at Weeks 52-60||9.4|-7.4|
72330590|NCT03304054|144186845|OTHER|||||||0.2196||||||P-value for Wilcoxon-Mann-Whitney Test of Equality of change from baseline distributions between the amifampridine phosphate and placebo treatment groups.|Wilcoxon (Mann-Whitney)|||A Wilcoxon-Mann-Whitney Rank Sum Test of equality of change from baseline distributions between subjects diagnosed with MuSK-MG treated with amifampridine and placebo was conducted.||||0.2196
72330591|NCT03304054|144186846|OTHER|||||||0.3736||||||P-value for Wilcoxon-Mann-Whitney Test of Equality of change from baseline distributions between the amifampridine phosphate and placebo treatment groups.|Wilcoxon (Mann-Whitney)|||A Wilcoxon-Mann-Whitney Rank Sum Test of equality of change from baseline distributions between subjects diagnosed with MuSK-MG treated with amifampridine and placebo was conducted.||||0.3736
72421998|NCT00991341|144355148|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.83||||0.5|TWO_SIDED|95.0|0.48|1.43|||Regression, Cox|The treatment groups were compared with respect to all-cause mortality, adjusting for baseline MODS.|The longer storage duration arm is the reference category.|||1.43|0.48|0.50
72330592|NCT04075292|144186889|SUPERIORITY||Hazard Ratio (HR)|0.08|||<|0.0001|TWO_SIDED|95.0|0.03|0.18|||Log Rank|The analysis was performed using the unstratified log-rank test.|HR was calculated using an unstratified Cox model with treatment as the only covariate. The CI for HR was calculated using the profile likelihood method.|||0.18|0.03|<0.0001
72330593|NCT03367403|144187029|SUPERIORITY||Mean Difference (Final Values)|3.2|STANDARD_ERROR_OF_MEAN|1.56||0.042|TWO_SIDED|95.0|0.12|6.27|||Mixed Models Analysis|||||6.27|0.12|0.042
72421999|NCT00991341|144355149|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.32||||0.2|TWO_SIDED|95.0|-0.82|0.17|||ANCOVA|The treatment groups were compared with respect to 28-day change in MODS, adjusting for baseline MODS.|The longer storage red blood cell units arm is the reference category. After adjusting for baseline MODS, the difference in the means was -0.32; positive values are in favor of longer storage duration.|||0.17|-0.82|0.20
72330594|NCT03367403|144187030|SUPERIORITY||Mean Difference (Final Values)|-1.86|STANDARD_ERROR_OF_MEAN|0.898||0.04|TWO_SIDED|95.0|-3.63|-0.09|||Mixed Models Analysis|||||-0.09|-3.63|0.040
72330595|NCT03367403|144187031|SUPERIORITY||Mean Difference (Final Values)|-0.36|STANDARD_ERROR_OF_MEAN|0.239||0.139|TWO_SIDED|95.0|-0.83|0.12|||Mixed Models Analysis|||||0.12|-0.83|0.139
72330596|NCT03367403|144187032|SUPERIORITY||Mean Difference (Final Values)|0.64|STANDARD_ERROR_OF_MEAN|0.525||0.227|TWO_SIDED|95.0|-0.4|1.67|||Mixed Models Analysis|||||1.67|-0.40|0.227
72330597|NCT03367403|144187033|SUPERIORITY||Mean Difference (Final Values)|1.21|STANDARD_ERROR_OF_MEAN|1.009||0.23|TWO_SIDED|95.0|-0.77|3.2|||Mixed Models Analysis|||||3.20|-0.77|0.230
72330598|NCT03367403|144187034|SUPERIORITY||Mean Difference (Final Values)|-85.06|STANDARD_ERROR_OF_MEAN|3.867|<|0.001|TWO_SIDED|95.0|-92.68|-77.43|||Mixed Models Analysis|||||-77.43|-92.68|<0.001
72330599|NCT03367403|144187035|SUPERIORITY||Mean Difference (Final Values)|0.01||||0.56|TWO_SIDED|95.0|-0.01|0.03|||ANCOVA|||Tau-IQ||0.03|-0.01|0.560
72330600|NCT03367403|144187035|SUPERIORITY||Mean Difference (Final Values)|0.035||||0.012|TWO_SIDED|95.0|0.007|0.062|||ANCOVA|||MUBADA-Cerebellum||0.062|0.007|0.012
72330601|NCT03367403|144187036|SUPERIORITY||Mean Difference (Final Values)|-2.67|STANDARD_ERROR_OF_MEAN|0.631|<|0.001|TWO_SIDED|95.0|-3.92|-1.43|||Mixed Models Analysis|||Bilateral Cortical||-1.43|-3.92|< 0.001
72330602|NCT03367403|144187036|SUPERIORITY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.011||0.916|TWO_SIDED|95.0|-0.02|0.02|||Mixed Models Analysis|||Bilateral Entorhinal Cortex||0.02|-0.02|0.916
72422000|NCT00991341|144355150|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.018||||0.5|TWO_SIDED|95.0|-0.033|0.069|||Fisher Exact||The difference in proportions between the two treatment arms was computed as the proportion of subjects with the event in the shorter storage duration arm minus the proportion of subjects with the event in the longer storage duration arm.|||0.069|-0.033|0.50
72422001|NCT00991341|144355151|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.027||||0.4|TWO_SIDED|95.0|-0.09|0.035|||Fisher Exact||The difference in proportions between the two treatment arms was computed as the proportion of subjects with the event in the shorter storage duration arm minus the proportion of subjects with the event in the longer storage duration arm.|||0.035|-0.090|0.40
72422002|NCT00991341|144355152|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.018||||0.41|TWO_SIDED|95.0|-0.059|0.023|||Fisher Exact||The difference in proportions between the two treatment arms was computed as the proportion of subjects with the event in the shorter storage duration arm minus the proportion of subjects with the event in the longer storage duration arm.|||0.023|-0.059|0.41
72422003|NCT00991341|144355153|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.12||||0.75|TWO_SIDED|95.0|-0.62|0.37|||Kruskal-Wallis|||||0.37|-0.62|0.75
72422004|NCT00991341|144355154|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.02||||0.62|TWO_SIDED|95.0|-0.08|0.05|||ANCOVA|The treatment arms were compared with respect to the change in creatinine, adjusting for the baseline creatinine value.|The longer storage red blood cell units arm is the reference category. After adjusting for baseline creatinine, the difference in the means was -0.02, positive values are in favor of longer storage duration.|||0.05|-0.08|0.62
72422005|NCT00991341|144355155|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.93||||0.35|TWO_SIDED|95.0|-2.11|5.98||The treatment arms were compared with respect to the change in troponin-I, adjusting for the baseline troponin-I value.|ANCOVA||The longer storage red blood cell units arm is the reference category. After adjusting for baseline troponin-I, the change in troponin-I values was 1.9 ng/mL higher in the shorter storage red blood cell units arm.|Troponin-I values recorded as 'too low to detect' were recoded as 0 since the median value of the minimum quantitative troponin-I value obtained among all participating sites was 0.01.||5.98|-2.11|0.35
72330603|NCT03367403|144187036|SUPERIORITY|Bilateral Hippocampus|Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.019||0.771|TWO_SIDED|95.0|-0.03|0.04|||Mixed Models Analysis|||||0.04|-0.03|0.771
72422006|NCT00991341|144355156|SUPERIORITY_OR_OTHER|||||||0.1|TWO_SIDED||||||Kruskal-Wallis|||||||0.10
72422007|NCT00991341|144355157|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.65|||<|0.01|TWO_SIDED|95.0|-0.89|-0.41|||ANCOVA||The longer storage red blood cell units arm is the reference category. After adjusting for baseline bilirubin, the change in bilirubin values was 0.65 mg/dL lower in the shorter storage red blood cell units arm.|||-0.41|-0.89|<0.01
72422008|NCT00991341|144355159|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.11||||0.11|TWO_SIDED|95.0|0.98|1.25||The treatment groups were compared with respect to days to first post-operative bowel movement, adjusting for baseline MODS.|Regression, Cox||The longer storage duration arm is reference category.|||1.25|0.98|0.11
72422009|NCT00991341|144355160|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.08||||0.22|TWO_SIDED|95.0|0.96|1.22|||Regression, Cox|The treatment groups were compared with respect to days to first post-operative solid food, adjusting for baseline MODS.|The longer storage duration arm is reference category.|||1.22|0.96|0.22
72422010|NCT00991341|144355161|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.21||||0.71|TWO_SIDED|95.0|-0.59|1.0|||Kruskal-Wallis||The longer storage duration arm is reference category.|||1.00|-0.59|0.71
72422011|NCT00991341|144355162|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.015||||0.53|TWO_SIDED|95.0|-0.057|0.027|||Fisher Exact||The difference in proportions between the two treatment arms was computed as the proportion of subjects with the event in the shorter storage duration arm minus the proportion of subjects with the event in the longer storage duration arm.|||0.027|-0.057|0.53
72422012|NCT00215540|144355163|SUPERIORITY_OR_OTHER|||||||0.476||95.0|||||Cochran-Mantel-Haenszel|Adjusting for pooled study center||Null hypothesis: No difference between treatment groups||||0.476
72422013|NCT00215540|144355163|SUPERIORITY_OR_OTHER|||||||0.208||95.0|||||Cochran-Mantel-Haenszel|Adjusting for pooled study center||Null hypothesis: No difference between treatment groups||||0.208
72422014|NCT00215540|144355164|SUPERIORITY_OR_OTHER|||||||0.5||95.0|||||Cochran-Mantel-Haenszel|Adjusting for pooled study center||Null hypothesis: No difference between treatment groups||||0.500
72422015|NCT00215540|144355164|SUPERIORITY_OR_OTHER|||||||0.146||95.0|||||Cochran-Mantel-Haenszel|Adjusting for pooled study center||Null hypothesis: No difference between treatment groups||||0.146
72330604|NCT03367403|144187036|SUPERIORITY||Mean Difference (Final Values)|-0.08|STANDARD_ERROR_OF_MEAN|0.047||0.094|TWO_SIDED|95.0|-0.17|0.01|||Mixed Models Analysis|||Bilateral Inferior Parietal Lobe||0.01|-0.17|0.094
72330605|NCT03367403|144187036|SUPERIORITY||Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.011||0.052|TWO_SIDED|95.0|-0.04|0.0|||Mixed Models Analysis|||Bilateral Isthmuscingulate||0.00|-0.04|0.052
72330606|NCT03367403|144187036|SUPERIORITY||Mean Difference (Final Values)|-0.34|STANDARD_ERROR_OF_MEAN|0.118||0.005|TWO_SIDED|95.0|-0.57|-0.11|||Mixed Models Analysis|||Bilateral Lateral Parietal Lobe||-0.11|-0.57|0.005
72330607|NCT03367403|144187036|SUPERIORITY||Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.036||0.731|TWO_SIDED|95.0|-0.08|0.06|||Mixed Models Analysis|||Bilateral Medial Temporal Lobe||0.06|-0.08|0.731
72330608|NCT03367403|144187036|SUPERIORITY||Mean Difference (Final Values)|-0.16|STANDARD_ERROR_OF_MEAN|0.046|<|0.001|TWO_SIDED|95.0|-0.25|-0.07|||Mixed Models Analysis|||Bilateral Precuneus||-0.07|-0.25|<0.001
72330609|NCT03367403|144187036|SUPERIORITY||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.114|<|0.001|TWO_SIDED|95.0|-0.62|-0.17|||Mixed Models Analysis|||Bilateral Prefrontal Lobe||-0.17|-0.62|<0.001
72422016|NCT00215540|144355165|SUPERIORITY_OR_OTHER|||||||0.267||95.0|||||Cochran-Mantel-Haenszel|Adjusting for pooled study center||||||0.267
72422017|NCT00215540|144355165|SUPERIORITY_OR_OTHER|||||||0.313||95.0|||||Cochran-Mantel-Haenszel|Adjusting for pooled study center||||||0.313
72422018|NCT00215540|144355165|SUPERIORITY_OR_OTHER|||||||0.944||95.0|||||Cochran-Mantel-Haenszel|Adjusting for pooled study center||||||0.944
72422019|NCT00215540|144355166|SUPERIORITY_OR_OTHER|||||||0.476||95.0|||||Cochran-Mantel-Haenszel|Adjusting for pooled study center||||||0.476
72422020|NCT00215540|144355166|SUPERIORITY_OR_OTHER|||||||0.208||95.0|||||Cochran-Mantel-Haenszel|Adjusting for pooled study center||||||0.208
72330610|NCT03367403|144187036|SUPERIORITY||Mean Difference (Final Values)|-0.21|STANDARD_ERROR_OF_MEAN|0.044|<|0.001|TWO_SIDED|95.0|-0.3|-0.12|||Mixed Models Analysis|||Bilateral Superior Temporal Lobe||-0.12|-0.30|<0.001
72422021|NCT00215540|144355166|SUPERIORITY_OR_OTHER|||||||0.046||95.0|||||Cochran-Mantel-Haenszel|Adjusting for pooled study center||||||0.046
72422022|NCT00215540|144355167|SUPERIORITY_OR_OTHER|||||||0.285||95.0|||||ANOVA|On rank adjusting for pooled study center||||||0.285
72422023|NCT00215540|144355167|SUPERIORITY_OR_OTHER|||||||0.229||95.0|||||ANOVA|On rank adjusting for pooled study center||||||0.229
72422024|NCT00215540|144355167|SUPERIORITY_OR_OTHER|||||||0.03||95.0|||||ANOVA|On rank adjusting for pooled study center||||||0.030
72422025|NCT00215540|144355168|SUPERIORITY_OR_OTHER|||||||0.483||95.0|||||ANOVA|On rank adjusting for pooled study center||||||0.483
72422026|NCT00215540|144355168|SUPERIORITY_OR_OTHER|||||||0.123||95.0|||||ANOVA|On rank adjusting for pooled study center||||||0.123
72422027|NCT00215540|144355168|SUPERIORITY_OR_OTHER|||||||0.006||95.0|||||ANOVA|On rank adjusting for pooled study center||||||0.006
72422028|NCT00215540|144355169|SUPERIORITY_OR_OTHER|||||||0.843||95.0|||||ANOVA|Adjusting for pooled study center||||||0.843
72422029|NCT00215540|144355169|SUPERIORITY_OR_OTHER|||||||0.543||95.0|||||ANOVA|Adjusting for pooled study center||||||0.543
72422030|NCT00215540|144355169|SUPERIORITY_OR_OTHER|||||||0.537||95.0|||||ANOVA|Adjusting for pooled study center||||||0.537
72330611|NCT03367403|144187036|SUPERIORITY||Mean Difference (Final Values)|2.28|STANDARD_ERROR_OF_MEAN|0.581|<|0.001|TWO_SIDED|95.0|1.14|3.43|||Mixed Models Analysis|||Bilateral Ventricles||3.43|1.14|< 0.001
72330612|NCT03367403|144187036|SUPERIORITY||Mean Difference (Final Values)|-4.58|STANDARD_ERROR_OF_MEAN|1.519||0.003|TWO_SIDED|95.0|-7.58|-1.59|||Mixed Models Analysis|||Bilateral Whole Brain||-1.59|-7.58|0.003
72330613|NCT03367403|144187036|SUPERIORITY||Mean Difference (Final Values)|-0.68|STANDARD_ERROR_OF_MEAN|0.178|<|0.001|TWO_SIDED|95.0|-1.03|-0.33|||Mixed Models Analysis|||Bilateral Whole Temporal Lobe||-0.33|-1.03|<0.001
72330614|NCT03367403|144187036|SUPERIORITY||Mean Difference (Final Values)|-2.28|STANDARD_ERROR_OF_MEAN|0.987||0.022|TWO_SIDED|95.0|-4.23|-0.33|||Mixed Models Analysis|||Bilateral White Matter||-0.33|-4.23|0.022
72330615|NCT03470194|144187045|OTHER||||||=|0.002|||||||Wilcoxon (Mann-Whitney)|||||||=0.002
72330616|NCT01822899|144187066|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.08|||<|0.001|TWO_SIDED|95.0|0.046|0.113|||ANCOVA|||||0.113|0.046|<0.001
72368880|NCT03284307|144247455|SUPERIORITY|||||||0.012||||||Statistical significance defined by p \< 0.05.|t-test, 2 sided|6 degrees of freedom||NIH Toolbox Card Sorting Score||||0.012
72368881|NCT03284307|144247455|SUPERIORITY|||||||0.487||||||Statistical significance defined by p \< 0.05.|t-test, 2 sided|1 degree of freedom||NIH Toolbox Card Sorting Score||||0.487
72330617|NCT03636893|144187101|OTHER|Two-sided log-rank test comparing disease-free survival between treatment groups. No adjustment for multiple comparisons as this was a pre-specified secondary endpoint. Statistical significance set at P \<0.05.|Hazard Ratio (HR)|1.06||||0.842|TWO_SIDED|95.0|0.597|1.884||P-value from two-sided log-rank test. Alpha level set at 0.05.|Log Rank|Kaplan-Meier survival analysis with log-rank test for between-group comparison. Analysis performed using SPSS version 30.0.|Hazard ratio from Cox proportional hazards regression with FLOT as reference group.|Disease-free survival analysis in intention-to-treat population. DFS defined as time from randomization to first occurrence of local recurrence, regional recurrence, distant metastases, or death from any cause.|Kaplan-Meier method used to estimate DFS curves. Cox regression performed to calculate hazard ratios.|1.884|0.597|0.842
72330618|NCT03636893|144187102|OTHER|Two-sided log-rank test comparing overall survival between treatment groups. No adjustment for multiple comparisons as this was a pre-specified secondary endpoint. Statistical significance set at P \<0.05.|Hazard Ratio (HR)|1.101||||0.759|TWO_SIDED|95.0|0.595|2.036||P-value from two-sided log-rank test. No adjustment for multiple comparisons as overall survival was a pre-specified secondary endpoint. Alpha level set at 0.05.|Log Rank|Kaplan-Meier survival analysis with log-rank test for between-group comparison. Analysis performed using SPSS version 30.0.|Hazard ratio from Cox proportional hazards regression with FLOT as reference group.|Primary survival analysis comparing overall survival between neoadjuvant FLOT and SOX regimens in intention-to-treat population.|Kaplan-Meier method used to estimate survival curves. Cox regression performed to calculate hazard ratios. Multivariable analysis performed to identify independent predictors.|2.036|0.595|0.759
72422031|NCT00215540|144355170|SUPERIORITY_OR_OTHER|||||||0.813||95.0|||||ANOVA|Adjusting for pooled study center||||||0.813
72422032|NCT00215540|144355170|SUPERIORITY_OR_OTHER|||||||0.449||95.0|||||ANOVA|Adjusting for pooled study center||||||0.449
72422033|NCT00215540|144355170|SUPERIORITY_OR_OTHER|||||||0.275||95.0|||||ANOVA|Adjusting for pooled study center||||||0.275
72422034|NCT00215540|144355171|SUPERIORITY_OR_OTHER|||||||0.267||95.0|||||Cochran-Mantel-Haenszel|Adjusting for pooled study center||||||0.267
72422035|NCT00215540|144355171|SUPERIORITY_OR_OTHER|||||||0.313||95.0|||||Cochran-Mantel-Haenszel|Adjusting for pooled study center||||||0.313
72330619|NCT00758069|144187103|SUPERIORITY_OR_OTHER||Least-squares Mean Difference|-25.9|||<|0.001||95.0|-34.2|-17.5||No multiplicity adjustment among the pairwise comparisons of sitagliptin against placebo|ANCOVA|ANCOVA model with terms of treatment as a factor and baseline value as a covariate was used for pairwise comparison|ANCOVA model with terms of treatment as a factor and baseline value as a covariate was used to estimate difference of two groups and its 95% confidence interval|||-17.5|-34.2|<0.001
72330620|NCT00758069|144187103|SUPERIORITY_OR_OTHER||Least-squares Mean Difference|-19.5|||<|0.001||95.0|-28.0|-11.1||No multiplicity adjustment among the pairwise comparisons of sitagliptin against placebo|ANCOVA|ANCOVA model with terms of treatment as a factor and baseline value as a covariate was used for pairwise comparison|ANCOVA model with terms of treatment as a factor and baseline value as a covariate was used to estimate difference of two groups and its 95% confidence interval|||-11.1|-28.0|<0.001
72330621|NCT00758069|144187104|SUPERIORITY_OR_OTHER||Least-squares Mean Difference|-19.3|||<|0.001||95.0|-26.6|-11.9||No multiplicity adjustment among the pairwise comparisons of sitagliptin against placebo|ANCOVA|ANCOVA model with terms of treatment as a factor and baseline value as a covariate was used for pairwise comparison|ANCOVA model with terms of treatment as a factor and baseline value as a covariate was used to estimate difference of two groups and its 95% confidence interval|||-11.9|-26.6|<0.001
72422036|NCT00215540|144355172|SUPERIORITY_OR_OTHER|||||||0.311||95.0|||||ANOVA|On rank adjusting for pooled study center||||||0.311
72422037|NCT00215540|144355172|SUPERIORITY_OR_OTHER|||||||0.516||95.0|||||ANOVA|On rank adjusting for pooled study center||||||0.516
72422038|NCT00215540|144355172|SUPERIORITY_OR_OTHER|||||||0.094||95.0|||||ANOVA|On rank adjusting for pooled study center||||||0.094
72422039|NCT03010462|144355173|SUPERIORITY|||||||0.62|||||||Chi-squared, Corrected|||||||0.62
72422040|NCT03010462|144355174|SUPERIORITY|||||||0.46|||||||Wilcoxon (Mann-Whitney)|||||||0.46
72422041|NCT03010462|144355175|SUPERIORITY|||||||0.54|||||||Wilcoxon (Mann-Whitney)|||||||0.54
72368882|NCT03284307|144247455|SUPERIORITY|||||||0.046||||||Statistical significance defined by p \< 0.05.|t-test, 2 sided|3 degrees of freedom||NIH Toolbox Flanker Score||||0.046
72368883|NCT03284307|144247455|SUPERIORITY|||||||0.01||||||Statistical significance defined by p \< 0.05.|t-test, 2 sided|6 degrees of freedom||NIH Toolbox Flanker Score||||0.010
72368884|NCT03284307|144247455|SUPERIORITY|||||||0.356||||||Statistical significance defined by p \< 0.05.|t-test, 2 sided|||NIH Toolbox Flanker Score||||0.356
72368885|NCT03284307|144247456|SUPERIORITY||||||<|0.001||||||Statistical significance defined by p \< 0.05.|t-test, 2 sided|17 degrees of freedom||Predictive Coding Task Accuracy||||<0.001
72368886|NCT03284307|144247456|SUPERIORITY||||||<|0.001||||||Statistical significance defined by p \< 0.05.|t-test, 2 sided|14 degrees of freedom||Predictive Coding Task Accuracy||||<0.001
72368887|NCT03284307|144247456|SUPERIORITY|||||||0.067||||||Statistical significance defined by p \< 0.05.|t-test, 2 sided|4 degrees of freedom||Predictive Coding Task Accuracy||||0.067
72368888|NCT03284307|144247457|SUPERIORITY|||||||0.5||||||Statistical significance defined by p \< 0.05.|t-test, 2 sided|17 degrees of freedom||Null hypothesis is a 50% recall rate.||||0.5
72368889|NCT03284307|144247457|SUPERIORITY|||||||0.37||||||Statistical significance defined by p \< 0.05.|t-test, 2 sided|11 degrees of freedom||Null hypothesis is a 50% recall rate.||||0.37
72368890|NCT03284307|144247457|SUPERIORITY|||||||0.12||||||Statistical significance defined by p \< 0.05.|t-test, 2 sided|4 degrees of freedom||Null hypothesis is a 50% recall rate.||||0.12
72368891|NCT03249116|144247510|SUPERIORITY||F statistic|0.33||||0.723|TWO_SIDED|||||The threshold for statistical significance was p\<.05|ANOVA|dependent variable: self-reported anxiety between-subjects factors: condition, social anxiety within-subjects factor: time||||||.723
72368892|NCT03249116|144247511|SUPERIORITY||F statistic|1.34||||0.271|TWO_SIDED|||||The threshold for statistical significance was p\<.05|ANOVA|dependent variable: electrodermal activity between-subjects factors: condition, social anxiety within-subjects factor: time||||||.271
72368893|NCT03249116|144247512|SUPERIORITY||F statistic|0.45||||0.638|TWO_SIDED|||||The threshold for statistical significance was p\<.05|ANOVA|dependent variable: heart rate between-subjects factors: condition, social anxiety within-subjects factor: time||||||.638
72368894|NCT03249116|144247513|SUPERIORITY||F statistic|0.14||||0.868|TWO_SIDED|||||The threshold for statistical significance was p\<.05|ANOVA|dependent variable: number of errors between-subjects factors: condition, social anxiety||||||.868
72368895|NCT03249116|144247514|SUPERIORITY||F statistic|0.21||||0.809|TWO_SIDED|||||The threshold for statistical significance was p\<.05|ANOVA|dependent variable: lowest number reached/highest number of correct responses between-subjects factors: condition, social anxiety||||||.809
72368896|NCT00221117|144247515|OTHER|||||||0.015|||||||Wilcoxon (Mann-Whitney)|||||||.015
72368897|NCT00221117|144247516|SUPERIORITY_OR_OTHER|||||||0.05|TWO_SIDED|95.0|||||Regression, Linear|||The subject's impairment and demographic characteristics were analyzed using descriptive statistics for parametric and nonparametric data. The baseline outcome data of the intervention and control groups were compared using Fisher exact test (for categorical variables) and Mann-Whitney U test (for continuous variables). Comparisons between the intervention and control groups were carried out using linear regression analysis adjusted for the baseline degree of disability (baseline AIS).||||0.05
72368898|NCT02974543|144247526|SUPERIORITY||||||<|0.05|||||||Mixed Models Analysis|||||||<0.05
72330622|NCT00758069|144187104|SUPERIORITY_OR_OTHER||Least-squares Mean Difference|-12.9|||<|0.001||95.0|-20.4|-5.4||No multiplicity adjustment among the pairwise comparisons of sitagliptin against placebo|ANCOVA|ANCOVA model with terms of treatment as a factor and baseline value as a covariate was used for pairwise comparison|ANCOVA model with terms of treatment as a factor and baseline value as a covariate was used to estimate difference of two groups and its 95% confidence interval|||-5.4|-20.4|<0.001
72330623|NCT02443116|144187230|SUPERIORITY||Difference in least squares means|-8.84|STANDARD_ERROR_OF_MEAN|1.37|<|0.001|TWO_SIDED|96.0|-12.09|-5.59||p-values are adjusted using a stepdown-Bonferroni method to adjust for multiple testing.|t-test, 2 sided|||The absolute change in liver fat content from baseline to Week 12 was compared between treatment groups using an ANCOVA model with treatment group and diabetic status as cofactors and baseline endpoint and baseline alanine aminotransferase (ALT) as covariates.||-5.59|-12.09|<0.001
72330624|NCT02443116|144187230|SUPERIORITY||Difference in least squares means|-11.06|STANDARD_ERROR_OF_MEAN|1.4|<|0.001|TWO_SIDED|96.0|-14.39|-7.74||p-values are adjusted using a stepdown-Bonferroni method to adjust for multiple testing.|t-test, 2 sided|||The absolute change in liver fat content from baseline to Week 12 was compared between treatment groups using an ANCOVA model with treatment group and diabetic status as cofactors and baseline endpoint and baseline alanine aminotransferase (ALT) as covariates.||-7.74|-14.39|<0.001
72368899|NCT02974543|144247527|SUPERIORITY||||||<|0.05|||||||Mixed Models Analysis|||||||<0.05
72368900|NCT04730271|144247534|NON_INFERIORITY|Test of non-inferiority: Absolute value deviation from plan with ROBOTIC is less than it is with manual instruments (not using ROBOTIC) under a non-inferiority margin of 1.5 degrees|||||<|0.0001|||||||t-test, 1 sided|||||||<0.0001
72368901|NCT04730271|144247535|SUPERIORITY|||||||0.0058|||||||t-test, 2 sided|||||||0.0058
72368902|NCT04730271|144247536|SUPERIORITY|||||||0.0282|||||||t-test, 2 sided|||||||0.0282
72368903|NCT04730271|144247537|SUPERIORITY|||||||0.0004|||||||t-test, 2 sided|||||||0.0004
72368904|NCT04730271|144247538|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
72368905|NCT04730271|144247539|SUPERIORITY|||||||0.633|||||||Chi-squared|||Comparison between the proportion of Robotic and Manual subjects who had a local adverse event within 1 year of the procedure.||||0.6330
72368906|NCT04730271|144247539|SUPERIORITY|||||||0.04|||||||Fisher Exact|||Comparison between the proportion of Robotic and Manual subjects who had a serious local adverse event within 1 year of the procedure.||||0.0400
72422042|NCT03010462|144355176|SUPERIORITY|||||||0.59|||||||Wilcoxon (Mann-Whitney)|||||||0.59
72422043|NCT03010462|144355177|SUPERIORITY|||||||0.7|||||||Wilcoxon (Mann-Whitney)|||||||0.70
72422044|NCT02207725|144355179|SUPERIORITY||Hodges-Lehman estimate of shift|-74.55|||<|0.0001|TWO_SIDED|95.0|-78.39|-66.28|||2-sided test exact Wilcoxon rank-sum tes|||||-66.28|-78.39|<0.0001
72330625|NCT02443116|144187230|SUPERIORITY||Difference in least squares means|-2.22|STANDARD_ERROR_OF_MEAN|1.38||0.112|TWO_SIDED|96.0|-5.11|0.67|||t-test, 2 sided|||The absolute change in liver fat content from baseline to Week 12 was compared between treatment groups using an ANCOVA model with treatment group and diabetic status as cofactors and baseline endpoint and baseline alanine aminotransferase (ALT) as covariates.||0.67|-5.11|0.112
72422045|NCT02207725|144355179|SUPERIORITY||Hodges-Lehman estimate of shift|-59.5|||<|0.0001|TWO_SIDED|95.0|-64.1|-55.17|||2-sided test exact Wilcoxon rank-sum tes|||||-55.17|-64.10|<0.0001
72422046|NCT02207725|144355180|SUPERIORITY||Hodges-Lehman estimate of shift|-77.14|||<|0.0001|TWO_SIDED|95.0|-79.98|-74.04|||2-sided test exact Wilcoxon rank-sum tes|||||-74.04|-79.98|<0.0001
72422047|NCT02207725|144355182|SUPERIORITY||Hodges-Lehman estimate of shift|-7.09|||<|0.0001|TWO_SIDED|95.0|-8.86|-5.42|||2-sided test exact Wilcoxon rank-sum tes|||||-5.42|-8.86|<0.0001
72330626|NCT02443116|144187231|SUPERIORITY||Difference in least squares means|-5.73|STANDARD_ERROR_OF_MEAN|1.38|<|0.0001|TWO_SIDED|95.0|-8.48|-2.99|||t-test, 2 sided|||The absolute change in liver fat content from baseline to Week 12 was compared between treatment groups using an ANCOVA model with treatment group and diabetic status as cofactors and baseline endpoint and baseline alanine aminotransferase (ALT) as covariates.||-2.99|-8.48|<0.0001
72422048|NCT02207725|144355182|SUPERIORITY||Hodges-Lehman estimate of shift|-3.02||||0.0002|TWO_SIDED|95.0|-5.66|-1.25|||2-sided test exact Wilcoxon rank-sum tes|||||-1.25|-5.66|0.0002
72422049|NCT02207725|144355183|SUPERIORITY||Hodges-Lehman estimate of shift|1227.35|||<|0.0001|TWO_SIDED|95.0|984.01|1456.38|||2-sided test exact Wilcoxon rank-sum tes|||||1456.38|984.01|<0.0001
72422050|NCT02207725|144355183|SUPERIORITY||Hodges-Lehman estimate of shift|999.33|||<|0.0001|TWO_SIDED|95.0|819.5|1200.53|||2-sided test exact Wilcoxon rank-sum tes|||||1200.53|819.50|<0.0001
72422051|NCT00431184|144355209|SUPERIORITY_OR_OTHER|||||||0.22|||||||Mixed Models Analysis|||||||0.22
72422052|NCT00431184|144355210|SUPERIORITY_OR_OTHER|||||||0.83|||||||Mixed Models Analysis|||||||0.83
72422053|NCT02799472|144355224|OTHER||Ratio|14.201|||<|0.001|TWO_SIDED|95.0|6.251|32.262|||Repeated measures analysis|||GM-CSF - Complex, Week 1||32.262|6.251|<0.001
72422054|NCT02799472|144355224|OTHER||Ratio|32.36|||<|0.001|TWO_SIDED|95.0|15.828|66.156|||Repeated measures analysis|||GM-CSF - Complex, Week 2||66.156|15.828|<0.001
72422055|NCT02799472|144355224|OTHER||Ratio|55.772|||<|0.001|TWO_SIDED|95.0|25.646|121.287|||Repeated measures analysis|||GM-CSF - Complex, Week 4||121.287|25.646|<0.001
72422056|NCT02799472|144355224|OTHER||Ratio|48.336|||<|0.001|TWO_SIDED|95.0|19.341|120.798|||Repeated measures analysis|||GM-CSF - Complex, Week 6||120.798|19.341|<0.001
72422057|NCT02799472|144355224|OTHER||Ratio|34.635|||<|0.001|TWO_SIDED|95.0|13.69|87.629|||Repeated measures analysis|||GM-CSF - Complex, Week 8||87.629|13.690|<0.001
72422058|NCT02799472|144355224|OTHER||Ratio|23.249|||<|0.001|TWO_SIDED|95.0|8.579|63.005|||Repeated measures analysis|||GM-CSF - Complex, Week 12||63.005|8.579|<0.001
72422059|NCT02799472|144355224|OTHER||Ratio|1.233||||0.401|TWO_SIDED|95.0|0.742|2.048|||Repeated measures analysis|||GM-CSF - Complex, 12-Week FU||2.048|0.742|0.401
72422060|NCT02799472|144355225|OTHER||Ratio|0.943||||0.193|TWO_SIDED|95.0|0.861|1.032|||Repeated measures analysis|||14-3-3 ETA Protein, Week 1||1.032|0.861|0.193
72422061|NCT02799472|144355225|OTHER||Ratio|1.028||||0.842|TWO_SIDED|95.0|0.776|1.362|||Repeated measures analysis|||14-3-3 ETA Protein, Week 2||1.362|0.776|0.842
72422062|NCT02799472|144355225|OTHER||Ratio|0.743||||0.127|TWO_SIDED|95.0|0.505|1.093|||Repeated measures analysis|||14-3-3 ETA Protein, Week 4||1.093|0.505|0.127
72422063|NCT02799472|144355225|OTHER||Ratio|0.762||||0.137|TWO_SIDED|95.0|0.531|1.095|||Repeated measures analysis|||14-3-3 ETA Protein, Week 6||1.095|0.531|0.137
72330627|NCT02443116|144187231|SUPERIORITY||Difference in least squares means|-6.6|STANDARD_ERROR_OF_MEAN|1.41|<|0.0001|TWO_SIDED|95.0|-9.41|-3.79|||t-test, 2 sided|||The absolute change in liver fat content from baseline to Week 12 was compared between treatment groups using an ANCOVA model with treatment group and diabetic status as cofactors and baseline endpoint and baseline alanine aminotransferase (ALT) as covariates.||-3.79|-9.41|<0.0001
72330628|NCT02443116|144187231|SUPERIORITY||Difference in least squares means|-0.87|STANDARD_ERROR_OF_MEAN|1.43||0.5467|TWO_SIDED|95.0|-3.71|1.98|||t-test, 2 sided|||The absolute change in liver fat content from baseline to Week 12 was compared between treatment groups using an ANCOVA model with treatment group and diabetic status as cofactors and baseline endpoint and baseline alanine aminotransferase (ALT) as covariates.||1.98|-3.71|0.5467
72422064|NCT02799472|144355225|OTHER||Ratio|0.886||||0.488|TWO_SIDED|95.0|0.623|1.259|||Repeated measures analysis|||14-3-3 ETA Protein, Week 8||1.259|0.623|0.488
72330629|NCT02443116|144187231|SUPERIORITY||Difference in least squares means|-5.9|STANDARD_ERROR_OF_MEAN|1.33|<|0.0001|TWO_SIDED|95.0|-8.55|-3.25|||t-test, 2 sided|||The absolute change in liver fat content from baseline to Week 12 was compared between treatment groups using an ANCOVA model with treatment group and diabetic status as cofactors and baseline endpoint and baseline alanine aminotransferase (ALT) as covariates.||-3.25|-8.55|<0.0001
72422065|NCT02799472|144355225|OTHER||Ratio|0.793||||0.338|TWO_SIDED|95.0|0.488|1.29|||Repeated measures analysis|||14-3-3 ETA Protein, Week 12||1.290|0.488|0.338
72330630|NCT02443116|144187231|SUPERIORITY||Difference in least squares means|-0.17|STANDARD_ERROR_OF_MEAN|1.37||0.9037|TWO_SIDED|95.0|-2.89|2.55|||t-test, 2 sided|||The absolute change in liver fat content from baseline to Week 12 was compared between treatment groups using an ANCOVA model with treatment group and diabetic status as cofactors and baseline endpoint and baseline alanine aminotransferase (ALT) as covariates.||2.55|-2.89|0.9037
72330631|NCT02443116|144187231|SUPERIORITY||Difference in least squares means|0.7|STANDARD_ERROR_OF_MEAN|1.38||0.6134|TWO_SIDED|95.0|-2.05|3.45|||t-test, 2 sided|||The absolute change in liver fat content from baseline to Week 12 was compared between treatment groups using an ANCOVA model with treatment group and diabetic status as cofactors and baseline endpoint and baseline alanine aminotransferase (ALT) as covariates.||3.45|-2.05|0.6134
72422066|NCT02799472|144355225|OTHER||Ratio|0.859||||0.582|TWO_SIDED|95.0|0.491|1.502|||Repeated measures analysis|||14-3-3 ETA Protein, 12-Week FU||1.502|0.491|0.582
72422067|NCT02799472|144355225|OTHER||Ratio|0.999||||0.996|TWO_SIDED|95.0|0.699|1.427|||Repeated measures analysis|||S100 CBP A8 and A9, Week 1||1.427|0.699|0.996
72422068|NCT02799472|144355225|OTHER||Ratio|0.944||||0.745|TWO_SIDED|95.0|0.662|1.346|||Repeated measures analysis|||S100 CBP A8 and A9, Week 2||1.346|0.662|0.745
72422069|NCT02799472|144355225|OTHER||Ratio|1.017||||0.939|TWO_SIDED|95.0|0.649|1.593|||Repeated measures analysis|||S100 CBP A8 and A9, Week 4||1.593|0.649|0.939
72422070|NCT02799472|144355225|OTHER||Ratio|0.981||||0.937|TWO_SIDED|95.0|0.595|1.617|||Repeated measures analysis|||S100 CBP A8 and A9, Week 6||1.617|0.595|0.937
72422071|NCT02799472|144355225|OTHER||Ratio|1.067||||0.787|TWO_SIDED|95.0|0.659|1.727|||Repeated measures analysis|||S100 CBP A8 and A9, Week 8||1.727|0.659|0.787
72422072|NCT02799472|144355225|OTHER||Ratio|1.267||||0.342|TWO_SIDED|95.0|0.769|2.086|||Repeated measures analysis|||S100 CBP A8 and A9, Week 12||2.086|0.769|0.342
72422073|NCT02799472|144355225|OTHER||Ratio|1.748||||0.026|TWO_SIDED|95.0|1.076|2.838|||Repeated measures analysis|||S100 CBP A8 and A9, 12-Week FU||2.838|1.076|0.026
72422074|NCT02799472|144355226|OTHER||Ratio|0.774||||0.632|TWO_SIDED|95.0|0.261|2.29|||Repeated measures analysis|||Amyloid A, Week 12||2.290|0.261|0.632
72422075|NCT02799472|144355226|OTHER||Ratio|1.176||||0.685|TWO_SIDED|95.0|0.519|2.663|||Repeated measures analysis|||Amyloid A, 12-Week FU||2.663|0.519|0.685
72422076|NCT02799472|144355227|OTHER||Ratio|0.692||||0.097|TWO_SIDED|95.0|0.445|1.074|||Repeated measures analysis|||CL17, Week 1||1.074|0.445|0.097
72422077|NCT02799472|144355227|OTHER||Ratio|0.713||||0.229|TWO_SIDED|95.0|0.407|1.249|||Repeated measures analysis|||CL17, Week 2||1.249|0.407|0.229
72422078|NCT02799472|144355227|OTHER||Ratio|0.608||||0.055|TWO_SIDED|95.0|0.365|1.012|||Repeated measures analysis|||CL17, Week 4||1.012|0.365|0.055
72422079|NCT02799472|144355227|OTHER||Ratio|0.755||||0.307|TWO_SIDED|95.0|0.435|1.309|||Repeated measures analysis|||CL17, Week 6||1.309|0.435|0.307
72422080|NCT02799472|144355227|OTHER||Ratio|0.557||||0.017|TWO_SIDED|95.0|0.348|0.894|||Repeated measures analysis|||CL17, Week 8||0.894|0.348|0.017
72422081|NCT02799472|144355227|OTHER||Ratio|0.52||||0.026|TWO_SIDED|95.0|0.294|0.922|||Repeated measures analysis|||||0.922|0.294|0.026
72422082|NCT02799472|144355227|OTHER||Ratio|0.947||||0.839|TWO_SIDED|95.0|0.548|1.636|||Repeated measures analysis|||CL17, 12-Week FU||1.636|0.548|0.839
72422083|NCT02799472|144355227|OTHER||Ratio|0.764||||0.142|TWO_SIDED|95.0|0.53|1.1|||Repeated measures analysis|||CL13, Week 1||1.100|0.530|0.142
72422084|NCT02799472|144355227|OTHER||Ratio|1.005||||0.976|TWO_SIDED|95.0|0.726|1.39|||Repeated measures analysis|||CL13, Week 2||1.390|0.726|0.976
72422085|NCT02799472|144355227|OTHER||Ratio|1.236||||0.244|TWO_SIDED|95.0|0.859|1.778|||Repeated measures analysis|||CL13, Week 4||1.778|0.859|0.244
72422086|NCT02799472|144355227|OTHER||Ratio|1.237||||0.278|TWO_SIDED|95.0|0.836|1.83|||Repeated measures analysis|||CL13, Week 6||1.830|0.836|0.278
72422087|NCT02799472|144355227|OTHER||Ratio|1.118||||0.677|TWO_SIDED|95.0|0.651|1.92|||Repeated measures analysis|||CL13, Week 8||1.920|0.651|0.677
72422088|NCT02799472|144355227|OTHER||Ratio|1.165||||0.661|TWO_SIDED|95.0|0.573|2.369|||Repeated measures analysis|||CL13, Week 12||2.369|0.573|0.661
72422089|NCT02799472|144355227|OTHER||Ratio|1.581||||0.154|TWO_SIDED|95.0|0.832|3.007|||Repeated measures analysis|||CL13, 12-Week FU||3.007|0.832|0.154
72422090|NCT02799472|144355227|OTHER||Ratio|0.903||||0.751|TWO_SIDED|95.0|0.471|1.729|||Repeated measures analysis|||Interleukin 6, Week 1||1.729|0.471|0.751
72422091|NCT02799472|144355227|OTHER||Ratio|0.72||||0.33|TWO_SIDED|95.0|0.367|1.413|||Repeated measures analysis|||Interleukin 6, Week 2||1.413|0.367|0.330
72422092|NCT02799472|144355227|OTHER||Ratio|0.822||||0.519|TWO_SIDED|95.0|0.447|1.512|||Repeated measures analysis|||Interleukin 6, Week 4||1.512|0.447|0.519
72422093|NCT02799472|144355227|OTHER||Ratio|0.659||||0.147|TWO_SIDED|95.0|0.372|1.167|||Repeated measures analysis|||Interleukin 6, Week 6||1.167|0.372|0.147
72422094|NCT02799472|144355227|OTHER||Ratio|0.684||||0.166|TWO_SIDED|95.0|0.396|1.18|||Repeated measures analysis|||Interleukin 6, Week 8||1.180|0.396|0.166
72422095|NCT02799472|144355227|OTHER||Ratio|1.221||||0.432|TWO_SIDED|95.0|0.734|2.031|||Repeated measures analysis|||Interleukin 6, Week 12||2.031|0.734|0.432
72422096|NCT02799472|144355227|OTHER||Ratio|1.602||||0.216|TWO_SIDED|95.0|0.75|3.423|||Repeated measures analysis|||Interleukin 6, 12-Week FU||3.423|0.750|0.216
72422097|NCT02799472|144355227|OTHER||Ratio|0.926||||0.195|TWO_SIDED|95.0|0.823|1.042|||Repeated measures analysis|||MDC, Week 1||1.042|0.823|0.195
72422098|NCT02799472|144355227|OTHER||Ratio|0.984||||0.851|TWO_SIDED|95.0|0.829|1.168|||Repeated measures analysis|||MDC, Week 2||1.168|0.829|0.851
72422099|NCT02799472|144355227|OTHER||Ratio|0.956||||0.637|TWO_SIDED|95.0|0.79|1.158|||Repeated measures analysis|||MDC, Week 4||1.158|0.790|0.637
72330632|NCT02443116|144187232|SUPERIORITY||Difference in least squares means|-4.97|STANDARD_ERROR_OF_MEAN|1.53||0.0018|TWO_SIDED|95.0|-8.03|-1.91|||t-test, 2 sided|||The absolute change in liver fat content from baseline to Week 12 was compared between treatment groups using an ANCOVA model with treatment group and diabetic status as cofactors and baseline endpoint and baseline alanine aminotransferase (ALT) as covariates.||-1.91|-8.03|0.0018
72330633|NCT01932372|144187239|OTHER||Incidence rate ratio (unadjusted)|4.85|||||TWO_SIDED|95.0|3.34|7.03||||||||7.03|3.34|
72330634|NCT01932372|144187239|OTHER||Hazard ratio (unadjusted)|4.8|||||TWO_SIDED|95.0|3.31|6.96||||||||6.96|3.31|
72422100|NCT02799472|144355227|OTHER||Ratio|1.01||||0.915|TWO_SIDED|95.0|0.833|1.225|||Repeated measures analysis|||MDC, Week 6||1.225|0.833|0.915
72422101|NCT02799472|144355227|OTHER||Ratio|0.857||||0.157|TWO_SIDED|95.0|0.69|1.064|||Repeated measures analysis|||MDC, Week 8||1.064|0.690|0.157
72422102|NCT02799472|144355227|OTHER||Ratio|0.849||||0.142|TWO_SIDED|95.0|0.681|1.059|||Repeated measures analysis|||MDC, Week 12||1.059|0.681|0.142
72422103|NCT02799472|144355227|OTHER||Ratio|1.013||||0.929|TWO_SIDED|95.0|0.745|1.378|||Repeated measures analysis|||MDC, 12-Week FU||1.378|0.745|0.929
72422104|NCT02799472|144355228|OTHER||Ratio|0.887||||0.463|TWO_SIDED|95.0|0.64|1.231|||Repeated measures analysis|||Chitinase 3 Like 1, Week 1||1.231|0.640|0.463
72422105|NCT02799472|144355228|OTHER||Ratio|0.953||||0.782|TWO_SIDED|95.0|0.672|1.352|||Repeated measures analysis|||Chitinase 3 Like 1, Week 2||1.352|0.672|0.782
72422106|NCT02799472|144355228|OTHER||Ratio|1.132||||0.533|TWO_SIDED|95.0|0.759|1.69|||Repeated measures analysis|||Chitinase 3 Like 1, Week 4||1.690|0.759|0.533
72422107|NCT02799472|144355228|OTHER||Ratio|1.149||||0.473|TWO_SIDED|95.0|0.779|1.694|||Repeated measures analysis|||Chitinase 3 Like 1, Week 6||1.694|0.779|0.473
72422108|NCT02799472|144355228|OTHER||Ratio|1.112||||0.608|TWO_SIDED|95.0|0.733|1.687|||Repeated measures analysis|||Chitinase 3 Like 1, Week 8||1.687|0.733|0.608
72422109|NCT02799472|144355228|OTHER||Ratio|1.005||||0.985|TWO_SIDED|95.0|0.613|1.645|||Repeated measures analysis|||Chitinase 3 Like 1, Week 12||1.645|0.613|0.985
72422110|NCT02799472|144355228|OTHER||Ratio|1.386||||0.102|TWO_SIDED|95.0|0.934|2.057|||Repeated measures analysis|||Chitinase 3 Like 1, 12-Week FU||2.057|0.934|0.102
72330635|NCT01932372|144187239|OTHER||Hazard ratio (adjusted 1)|2.07|||||TWO_SIDED|95.0|0.95|4.51||||||||4.51|0.95|
72330636|NCT01932372|144187239|OTHER||Hazard ratio (adjusted 2)|3.81|||||TWO_SIDED|95.0|2.24|6.47||||||||6.47|2.24|
72330637|NCT01932372|144187239|OTHER||Hazard ratio (adjusted 3)|3.55|||||TWO_SIDED|95.0|2.08|6.09||||||||6.09|2.08|
72422111|NCT02799472|144355228|OTHER||Ratio|0.915||||0.259|TWO_SIDED|95.0|0.781|1.071|||Repeated measures analysis|||MMP-3, Week 1||1.071|0.781|0.259
72422112|NCT02799472|144355228|OTHER||Ratio|0.959||||0.621|TWO_SIDED|95.0|0.809|1.137|||Repeated measures analysis|||MMP-3, Week 2||1.137|0.809|0.621
72422113|NCT02799472|144355228|OTHER||Ratio|0.914||||0.354|TWO_SIDED|95.0|0.752|1.11|||Repeated measures analysis|||MMP-3, Week 4||1.110|0.752|0.354
72422114|NCT02799472|144355228|OTHER||Ratio|0.8||||0.448|TWO_SIDED|95.0|0.443|1.444|||Repeated measures analysis|||MMP-3, Week 6||1.444|0.443|0.448
72422115|NCT02799472|144355228|OTHER||Ratio|1.16||||0.402|TWO_SIDED|95.0|0.813|1.653|||Repeated measures analysis|||MMP-3, Week 8||1.653|0.813|0.402
72422116|NCT02799472|144355228|OTHER||Ratio|0.951||||0.745|TWO_SIDED|95.0|0.695|1.301|||Repeated measures analysis|||MMP-3, Week 12||1.301|0.695|0.745
72422117|NCT02799472|144355228|OTHER||Ratio|1.226||||0.279|TWO_SIDED|95.0|0.837|1.796|||Repeated measures analysis|||MMP-3, 12-Week FU||1.796|0.837|0.279
72422118|NCT02799472|144355229|OTHER||Ratio|1.098||||0.621|TWO_SIDED|95.0|0.75|1.606|||Repeated measures analysis|||ARGS Neo-Epitope, Week 1||1.606|0.750|0.621
72422119|NCT02799472|144355229|OTHER||Ratio|1.581||||0.031|TWO_SIDED|95.0|1.046|2.388|||Repeated measures analysis|||ARGS Neo-Epitope, Week 2||2.388|1.046|0.031
72422120|NCT02799472|144355229|OTHER||Ratio|1.222||||0.317|TWO_SIDED|95.0|0.817|1.827|||Repeated measures analysis|||ARGS Neo-Epitope, Week 4||1.827|0.817|0.317
72422121|NCT02799472|144355229|OTHER||Ratio|1.302||||0.113|TWO_SIDED|95.0|0.936|1.81|||Repeated measures analysis|||ARGS Neo-Epitope, Week 6||1.810|0.936|0.113
72422122|NCT02799472|144355229|OTHER||Ratio|1.45||||0.217|TWO_SIDED|95.0|0.795|2.645|||Repeated measures analysis|||ARGS Neo-Epitope, Week 8||2.645|0.795|0.217
72422123|NCT02799472|144355229|OTHER||Ratio|1.266||||0.147|TWO_SIDED|95.0|0.916|1.75|||Repeated measures analysis|||ARGS Neo-Epitope, Week 12||1.750|0.916|0.147
72422124|NCT02799472|144355229|OTHER||Ratio|0.996||||0.985|TWO_SIDED|95.0|0.662|1.499|||Repeated measures analysis|||ARGS Neo-Epitope, 12-Week FU||1.499|0.662|0.985
72422125|NCT02799472|144355229|OTHER||Ratio|0.892||||0.681|TWO_SIDED|95.0|0.511|1.56|||Repeated measures analysis|||CMDV, Week 1||1.560|0.511|0.681
72422126|NCT02799472|144355229|OTHER||Ratio|0.87||||0.668|TWO_SIDED|95.0|0.454|1.669|||Repeated measures analysis|||CMDV, Week 2||1.669|0.454|0.668
72330638|NCT01932372|144187239|OTHER||Hazard ratio (adjusted 4)|3.8|||||TWO_SIDED|95.0|2.31|6.25||||||||6.25|2.31|
72330639|NCT01932372|144187240|OTHER||Incidence rate ratio (unadjusted)|1.6|||||TWO_SIDED|95.0|1.16|2.19||||||||2.19|1.16|
72422127|NCT02799472|144355229|OTHER||Ratio|1.12||||0.717|TWO_SIDED|95.0|0.597|2.101|||Repeated measures analysis|||CMDV, Week 4||2.101|0.597|0.717
72422128|NCT02799472|144355229|OTHER||Ratio|0.661||||0.227|TWO_SIDED|95.0|0.333|1.31|||Repeated measures analysis|||CMDV, Week 6||1.310|0.333|0.227
72422129|NCT02799472|144355229|OTHER||Ratio|0.817||||0.471|TWO_SIDED|95.0|0.464|1.437|||Repeated measures analysis|||CMDV, Week 8||1.437|0.464|0.471
72422130|NCT02799472|144355229|OTHER||Ratio|0.816||||0.541|TWO_SIDED|95.0|0.417|1.597|||Repeated measures analysis|||CMDV, Week 12||1.597|0.417|0.541
72422131|NCT02799472|144355229|OTHER||Ratio|0.822||||0.544|TWO_SIDED|95.0|0.422|1.602|||Repeated measures analysis|||CMDV, 12-Week FU||1.602|0.422|0.544
72422132|NCT02799472|144355229|OTHER||Ratio|1.051||||0.537|TWO_SIDED|95.0|0.895|1.233|||Repeated measures analysis|||MMP-Degraded CRP, Week 1||1.233|0.895|0.537
72422133|NCT02799472|144355229|OTHER||Ratio|1.031||||0.635|TWO_SIDED|95.0|0.906|1.173|||Repeated measures analysis|||MMP-Degraded CRP, Week 2||1.173|0.906|0.635
72422134|NCT02799472|144355229|OTHER||Ratio|1.012||||0.866|TWO_SIDED|95.0|0.879|1.165|||Repeated measures analysis|||MMP-Degraded CRP, Week 4||1.165|0.879|0.866
72422135|NCT02799472|144355229|OTHER||Ratio|0.979||||0.78|TWO_SIDED|95.0|0.842|1.139|||Repeated measures analysis|||MMP-Degraded CRP, Week 6||1.139|0.842|0.780
72422136|NCT02799472|144355229|OTHER||Ratio|1.113||||0.212|TWO_SIDED|95.0|0.938|1.32|||Repeated measures analysis|||MMP-Degraded CRP, Week 8||1.320|0.938|0.212
72422137|NCT02799472|144355229|OTHER||Ratio|1.102||||0.242|TWO_SIDED|95.0|0.934|1.3|||Repeated measures analysis|||MMP-Degraded CRP, Week 12||1.300|0.934|0.242
72422138|NCT02799472|144355229|OTHER||Ratio|1.05||||0.597|TWO_SIDED|95.0|0.87|1.267|||Repeated measures analysis|||MMP-Degraded CRP, 12-Week FU||1.267|0.870|0.597
72422139|NCT02799472|144355229|OTHER||Ratio|0.795||||0.047|TWO_SIDED|95.0|0.634|0.997|||Repeated measures analysis|||MD1C, Week 1||0.997|0.634|0.047
72422140|NCT02799472|144355229|OTHER||Ratio|0.883||||0.367|TWO_SIDED|95.0|0.668|1.165|||Repeated measures analysis|||MD1C, Week 2||1.165|0.668|0.367
72422141|NCT02799472|144355229|OTHER||Ratio|0.784||||0.155|TWO_SIDED|95.0|0.558|1.102|||Repeated measures analysis|||MD1C, Week 4||1.102|0.558|0.155
72422142|NCT02799472|144355229|OTHER||Ratio|0.638||||0.004|TWO_SIDED|95.0|0.477|0.855|||Repeated measures analysis|||MD1C, Week 6||0.855|0.477|0.004
72330640|NCT01932372|144187240|OTHER||Hazard ratio (unadjusted)|1.55|||||TWO_SIDED|95.0|1.12|2.13||||||||2.13|1.12|
72330641|NCT01932372|144187240|OTHER||Hazard ratio (adjusted 1)|1.86|||||TWO_SIDED|95.0|1.16|2.99||||||||2.99|1.16|
72330642|NCT01932372|144187240|OTHER||Hazard ratio (adjusted 2)|1.61|||||TWO_SIDED|95.0|1.06|2.43||||||||2.43|1.06|
72330643|NCT01932372|144187240|OTHER||Hazard ratio (adjusted 3)|1.53|||||TWO_SIDED|95.0|1.0|2.35||||||||2.35|1.00|
72330644|NCT01932372|144187240|OTHER||Hazard ratio (adjusted 4)|1.51|||||TWO_SIDED|95.0|1.03|2.22||||||||2.22|1.03|
72330645|NCT01932372|144187241|OTHER||Mortality rate ratio (unadjusted)|3.39|||||TWO_SIDED|95.0|1.99|5.78||||||||5.78|1.99|
72330646|NCT01932372|144187241|OTHER||Hazard ratio (unadjusted)|3.29|||||TWO_SIDED|95.0|1.93|5.61||||||||5.61|1.93|
72330647|NCT02241733|144187248|SUPERIORITY|||||||0.94|||||||t-test, 2 sided|||An independent t-test was completed.||||0.94
72330648|NCT02241733|144187249|SUPERIORITY|||||||0.078|||||||t-test, 2 sided|||||||0.078
72422143|NCT02799472|144355229|OTHER||Ratio|0.799||||0.14|TWO_SIDED|95.0|0.591|1.08|||Repeated measures analysis|||MD1C, Week 8||1.080|0.591|0.140
72422144|NCT02799472|144355229|OTHER||Ratio|0.891||||0.47|TWO_SIDED|95.0|0.647|1.228|||Repeated measures analysis|||MD1C, Week 12||1.228|0.647|0.470
72422145|NCT02799472|144355229|OTHER||Ratio|0.869||||0.401|TWO_SIDED|95.0|0.621|1.217|||Repeated measures analysis|||MD1C, 12-Week FU||1.217|0.621|0.401
72422146|NCT02799472|144355229|OTHER||Ratio|0.981||||0.887|TWO_SIDED|95.0|0.742|1.296|||Repeated measures analysis|||MD2C, Week 1||1.296|0.742|0.887
72422147|NCT02799472|144355229|OTHER||Ratio|0.97||||0.814|TWO_SIDED|95.0|0.744|1.263|||Repeated measures analysis|||MD2C, Week 2||1.263|0.744|0.814
72422148|NCT02799472|144355229|OTHER||Ratio|0.969||||0.794|TWO_SIDED|95.0|0.762|1.233|||Repeated measures analysis|||MD2C, Week 4||1.233|0.762|0.794
72422149|NCT02799472|144355229|OTHER||Ratio|0.919||||0.539|TWO_SIDED|95.0|0.696|1.213|||Repeated measures analysis|||MD2C, Week 6||1.213|0.696|0.539
72422150|NCT02799472|144355229|OTHER||Ratio|0.937||||0.623|TWO_SIDED|95.0|0.719|1.221|||Repeated measures analysis|||MD2C, Week 8||1.221|0.719|0.623
72422151|NCT02799472|144355229|OTHER||Ratio|0.913||||0.467|TWO_SIDED|95.0|0.711|1.173|||Repeated measures analysis|||MD2C, Week 12||1.173|0.711|0.467
72422152|NCT02799472|144355229|OTHER||Ratio|0.778||||0.108|TWO_SIDED|95.0|0.57|1.061|||Repeated measures analysis|||MD2C, 12-Week FU||1.061|0.570|0.108
72422153|NCT02799472|144355229|OTHER||Ratio|1.01||||0.897|TWO_SIDED|95.0|0.868|1.175|||Repeated measures analysis|||MD3C, Week 1||1.175|0.868|0.897
72422154|NCT02799472|144355229|OTHER||Ratio|1.037||||0.644|TWO_SIDED|95.0|0.884|1.218|||Repeated measures analysis|||MD3C, Week 2||1.218|0.884|0.644
72330649|NCT02241733|144187250|SUPERIORITY|||||||0.8|||||||t-test, 2 sided|||||||0.80
72330650|NCT02241733|144187251|SUPERIORITY|||||||0.76|||||||t-test, 2 sided|||||||0.76
72422155|NCT02799472|144355229|OTHER||Ratio|0.943||||0.53|TWO_SIDED|95.0|0.78|1.139|||Repeated measures analysis|||MD3C, Week 4||1.139|0.780|0.530
72422156|NCT02799472|144355229|OTHER||Ratio|0.882||||0.182|TWO_SIDED|95.0|0.733|1.063|||Repeated measures analysis|||MD3C, Week 6||1.063|0.733|0.182
72422157|NCT02799472|144355229|OTHER||Ratio|0.96||||0.691|TWO_SIDED|10.0|0.779|1.182|||Repeated measures analysis|||MD3C, Week 8||1.182|0.779|0.691
72422158|NCT02799472|144355229|OTHER||Ratio|0.979||||0.843|TWO_SIDED|95.0|0.79|1.214|||Repeated measures analysis|||MD3C, Week 12||1.214|0.790|0.843
72422159|NCT02799472|144355229|OTHER||Ratio|1.075||||0.524|TWO_SIDED|95.0|0.855|1.351|||Repeated measures analysis|||MD3C, 12-Week FU||1.351|0.855|0.524
72422160|NCT02799472|144355230|OTHER||Ratio|0.953||||0.558|TWO_SIDED|95.0|0.809|1.123|||Repeated measures analysis|||Helper/Suppressor, Week 1||1.123|0.809|0.558
72422161|NCT02799472|144355230|OTHER||Ratio|0.947||||0.515|TWO_SIDED|95.0|0.801|1.12|||Repeated measures analysis|||Helper/Suppressor, Week 4||1.120|0.801|0.515
72422162|NCT02799472|144355230|OTHER||Ratio|1.046||||0.565|TWO_SIDED|95.0|0.895|1.222|||Repeated measures analysis|||Helper/Suppressor, Week 12||1.222|0.895|0.565
72422163|NCT02799472|144355230|OTHER||Ratio|1.013||||0.897|TWO_SIDED|95.0|0.822|1.249|||Repeated measures analysis|||Helper/Suppressor, 12-Week FU||1.249|0.822|0.897
72422164|NCT02799472|144355231|OTHER||Ratio|1.037||||0.786|TWO_SIDED|95.0|0.794|1.354|||Repeated measures analysis|||CD16+CD56+, Week 1||1.354|0.794|0.786
72422165|NCT02799472|144355231|OTHER||Ratio|0.818||||0.188|TWO_SIDED|95.0|0.603|1.109|||Repeated measures analysis|||CD16+CD56+, Week 4||1.109|0.603|0.188
72422166|NCT02799472|144355231|OTHER||Ratio|0.763||||0.129|TWO_SIDED|95.0|0.536|1.087|||Repeated measures analysis|||CD16+CD56+, Week 12||1.087|0.536|0.129
72422167|NCT02799472|144355231|OTHER||Ratio|0.709||||0.054|TWO_SIDED|95.0|0.499|1.006|||Repeated measures analysis|||CD16+CD56+, 12-Week FU||1.006|0.499|0.054
72422168|NCT02799472|144355231|OTHER||Ratio|1.119||||0.383|TWO_SIDED|95.0|0.863|1.45|||Repeated measures analysis|||CD19, Week 1||1.450|0.863|0.383
72422169|NCT02799472|144355231|OTHER||Ratio|0.89||||0.51|TWO_SIDED|95.0|0.623|1.271|||Repeated measures analysis|||CD19, Week 4||1.271|0.623|0.510
72422170|NCT02799472|144355231|OTHER||Ratio|0.952||||0.724|TWO_SIDED|95.0|0.718|1.262|||Repeated measures analysis|||CD19, Week 12||1.262|0.718|0.724
72422171|NCT02799472|144355231|OTHER||Ratio|0.958||||0.831|TWO_SIDED|95.0|0.635|1.443|||Repeated measures analysis|||CD19, 12-Week FU||1.443|0.635|0.831
72422172|NCT02799472|144355231|OTHER||Ratio|1.082||||0.437|TWO_SIDED|95.0|0.882|1.328|||Repeated measures analysis|||CD3, Week 1||1.328|0.882|0.437
72422173|NCT02799472|144355231|OTHER||Ratio|0.937||||0.632|TWO_SIDED|95.0|0.711|1.234|||Repeated measures analysis|||CD3, Week 4||1.234|0.711|0.632
72422174|NCT02799472|144355231|OTHER||Ratio|1.088||||0.413|TWO_SIDED|95.0|0.885|1.336|||Repeated measures analysis|||CD3, Week 12||1.336|0.885|0.413
72330651|NCT04576455|144187270|SUPERIORITY||Hazard Ratio (HR)|0.81||||0.1757|TWO_SIDED|95.0|0.6|1.1|||Log Rank|Stratified analysis (strata are: site of disease, prior CDK4/6i treatment, and prior fulvestrant treatment).|Giredestrant vs. PCET|||1.10|0.60|0.1757
72330652|NCT04576455|144187271|SUPERIORITY||Hazard Ratio (HR)|1.16||||0.3446|TWO_SIDED|95.0|0.85|1.6|||Log Rank|Stratified analysis (strata are: site of disease, prior CDK4/6i treatment, and prior fulvestrant treatment).|Giredestrant vs. PCET|||1.60|0.85|0.3446
72330653|NCT04576455|144187272|SUPERIORITY||Odds Ratio (OR)|1.87||||0.1126|TWO_SIDED|95.0|0.86|4.07|||Cochran-Mantel-Haenszel||Giredestrant vs. PCET|||4.07|0.86|0.1126
72330654|NCT04576455|144187272|SUPERIORITY||Difference in Objective Response Rates|5.35|||||TWO_SIDED|95.0|-1.97|12.78|||||Giredestrant vs. PCET|||12.78|-1.97|
72330655|NCT04576455|144187274|SUPERIORITY||Odds Ratio (OR)|1.79||||0.0289|TWO_SIDED|95.0|1.06|3.04|||Cochran-Mantel-Haenszel||Giredestrant vs. PCET|||3.04|1.06|0.0289
72330656|NCT04576455|144187274|SUPERIORITY||Difference in Clinical Benefit Rates|10.74|||||TWO_SIDED|95.0|0.33|20.86|||||Giredestrant vs. PCET|||20.86|0.33|
72330657|NCT04576455|144187275|SUPERIORITY||Hazard Ratio (HR)|0.6||||0.061|TWO_SIDED|95.0|0.35|1.03|||Log Rank|Stratified analysis (strata are: site of disease, prior CDK4/6i treatment, and prior fulvestrant treatment).|Giredestrant vs. PCET|This statistical analysis is done for PFS by ESR1 mutation detected at baseline||1.03|0.35|0.0610
72330658|NCT04576455|144187275|SUPERIORITY||Hazard Ratio (HR)|0.88||||0.5947|TWO_SIDED|95.0|0.54|1.42|||Log Rank|Stratified analysis (strata are: site of disease, prior CDK4/6i treatment, and prior fulvestrant treatment).|Giredestrant vs. PCET|This statistical analysis is done for PFS by ESR1 Mutation not detected at baseline||1.42|0.54|0.5947
72330659|NCT04576455|144187276|OTHER||Hazard Ratio (HR)|0.9|||||TWO_SIDED|95.0|0.58|1.4|||||Giredestrant vs. PCET|||1.40|0.58|
72330660|NCT04576455|144187277|OTHER||Hazard Ratio (HR)|0.74|||||TWO_SIDED|95.0|0.49|1.12|||||Giredestrant vs. PCET|||1.12|0.49|
72330661|NCT04576455|144187278|OTHER||Hazard Ratio (HR)|0.85|||||TWO_SIDED|95.0|0.53|1.35|||||Giredestrant vs. PCET|||1.35|0.53|
72330662|NCT04576455|144187279|OTHER||Hazard Ratio (HR)|1.1|||||TWO_SIDED|95.0|0.72|1.69|||||Giredestrant vs. PCET|||1.69|0.72|
72330663|NCT04576455|144187280|OTHER||Hazard Ratio (HR)|0.74|||||TWO_SIDED|95.0|0.47|1.18|||||Giredestrant vs. PCET|||1.18|0.47|
72330664|NCT02059499|144187286|SUPERIORITY|||||||0.1877||||||The threshold for statistical significance was p=0.05.|Cochran-Mantel-Haenszel|||||||0.1877
72330665|NCT02059499|144187287|SUPERIORITY|||||||0.1068||||||A priori threshold for statistical significance was p=0.05.|Cochran-Mantel-Haenszel|||||||0.1068
72330666|NCT02059499|144187288|SUPERIORITY|||||||0.8071||||||The threshold for statistical significance was p=0.05|Cochran-Mantel-Haenszel|||||||0.8071
72330667|NCT02059499|144187289|SUPERIORITY|||||||0.6562||||||The threshold for statistical significance was p=0.05|Cochran-Mantel-Haenszel|||||||0.6562
72330668|NCT02059499|144187290|SUPERIORITY|||||||0.0141||||||The threshold for statistical significance was p=0.05.|Cochran-Mantel-Haenszel|||||||0.0141
72330669|NCT02059499|144187291|SUPERIORITY|||||||0.0141||||||The threshold for statistical significance was p=0.05.|Cochran-Mantel-Haenszel|||||||0.0141
72330670|NCT02059499|144187295|SUPERIORITY|||||||0.1409||||||The threshold for statistical significance was p=0.05|Cochran-Mantel-Haenszel|||||||0.1409
72330671|NCT02059499|144187296|SUPERIORITY|||||||0.0805||||||The threshold for statistical significance was p=0.05|Cochran-Mantel-Haenszel|||||||0.0805
72330672|NCT02059499|144187298|SUPERIORITY|||||||0.5726|||||||Cochran-Mantel-Haenszel|||||||0.5726
72330673|NCT02059499|144187299|SUPERIORITY|||||||0.6184||||||The threshold for statistical significance was p=0.05.|Cochran-Mantel-Haenszel|||||||0.6184
72368907|NCT04730271|144247539|SUPERIORITY|||||||0.4079|||||||Chi-squared|||Comparison between the proportion of Robotic and Manual subjects who had a local adverse event within 90 days of the procedure.||||0.4079
72368908|NCT04730271|144247539|SUPERIORITY|||||||0.1262|||||||Chi-squared|||Comparison between the proportion of Robotic and Manual subjects who had a local serious adverse event within 90 days of the procedure.||||0.1262
72368909|NCT04730271|144247541|SUPERIORITY|||||||0.6662|||||||t-test, 2 sided|||T-test P-value for difference in change from baseline between ROBOTIC and MANUAL at 1 year||||0.6662
72422175|NCT02799472|144355231|OTHER||Ratio|1.062||||0.567|TWO_SIDED|95.0|0.858|1.316|||Repeated measures analysis|||CD3, 12-Week FU||1.316|0.858|0.567
72422176|NCT02799472|144355231|OTHER||Ratio|1.069||||0.547|TWO_SIDED|95.0|0.855|1.338|||Repeated measures analysis|||CD3+CD4+, Week 1||1.338|0.855|0.547
72422177|NCT02799472|144355231|OTHER||Ratio|0.907||||0.512|TWO_SIDED|95.0|0.673|1.223|||Repeated measures analysis|||CD3+CD4+, Week 4||1.223|0.673|0.512
72422178|NCT02799472|144355231|OTHER||Ratio|1.064||||0.573|TWO_SIDED|95.0|0.853|1.328|||Repeated measures analysis|||CD3+CD4+, Week 12||1.328|0.853|0.573
72422179|NCT02799472|144355231|OTHER||Ratio|1.031||||0.789|TWO_SIDED|95.0|0.818|1.3|||Repeated measures analysis|||CD3+CD4+, 12-Week FU||1.300|0.818|0.789
72422180|NCT02799472|144355232|OTHER||Mean Difference (Net)|0.036||||0.428|TWO_SIDED|95.0|-0.056|0.128|||Repeated measures analysis|||CD3+CD8+, Week 1||0.128|-0.056|0.428
72422181|NCT02799472|144355232|OTHER||Mean Difference (Net)|-0.023||||0.733|TWO_SIDED|95.0|-0.159|0.113|||Repeated measures analysis|||CD3+CD8+, Week 4||0.113|-0.159|0.733
72422182|NCT02799472|144355232|OTHER||Mean Difference (Net)|0.02||||0.677|TWO_SIDED|95.0|-0.076|0.115|||Repeated measures analysis|||CD3+CD8+, Week 12||0.115|-0.076|0.677
72422183|NCT02799472|144355232|OTHER||Mean Difference (Net)|0.033||||0.569|TWO_SIDED|95.0|-0.084|0.151|||Repeated measures analysis|||CD3+CD8+, 12-Week FU||0.151|-0.084|0.569
72422184|NCT02799472|144355232|OTHER||Mean Difference (Net)|0.103||||0.569|TWO_SIDED|95.0|-0.263|0.469|||Repeated measures analysis|||T Cell B Cell NKL, Week 1||0.469|-0.263|0.569
72422185|NCT02799472|144355232|OTHER||Mean Difference (Net)|-0.157||||0.534|TWO_SIDED|95.0|-0.668|0.354|||Repeated measures analysis|||T Cell B Cell NKL, Week 4||0.354|-0.668|0.534
72422186|NCT02799472|144355232|OTHER||Mean Difference (Net)|0.087||||0.668|TWO_SIDED|95.0|-0.323|0.498|||Repeated measures analysis|||T Cell B Cell NKL, Week 12||0.498|-0.323|0.668
72422187|NCT02799472|144355232|OTHER||Mean Difference (Net)|-0.021||||0.934|TWO_SIDED|95.0|-0.526|0.484|||Repeated measures analysis|||T Cell B Cell NKL, 12-Week FU||0.484|-0.526|0.934
72422188|NCT02799472|144355233|OTHER||Ratio|1.112||||0.369|TWO_SIDED|95.0|0.876|1.412|||Repeated measures analysis|||CD3+ CD4+, Week 1||1.412|0.876|0.369
72422189|NCT02799472|144355233|OTHER||Ratio|0.941||||0.641|TWO_SIDED|95.0|0.721|1.228|||Repeated measures analysis|||CD3+ CD4+, Week 4||1.228|0.721|0.641
72422190|NCT02799472|144355233|OTHER||Ratio|1.024||||0.844|TWO_SIDED|95.0|0.804|1.303|||Repeated measures analysis|||CD3+ CD4+, Week 12||1.303|0.804|0.844
72422191|NCT02799472|144355233|OTHER||Ratio|1.082||||0.558|TWO_SIDED|95.0|0.821|1.427|||Repeated measures analysis|||CD3+ CD4+, 12-Week FU||1.427|0.821|0.558
72422192|NCT02799472|144355233|OTHER||Ratio|1.111||||0.363|TWO_SIDED|95.0|0.88|1.402|||Repeated measures analysis|||CD3+ CD8+, Week 1||1.402|0.880|0.363
72422193|NCT02799472|144355233|OTHER||Ratio|0.957||||0.751|TWO_SIDED|95.0|0.724|1.265|||Repeated measures analysis|||CD3+ CD8+, Week 4||1.265|0.724|0.751
72422194|NCT02799472|144355233|OTHER||Ratio|1.076||||0.537|TWO_SIDED|95.0|0.846|1.37|||Repeated measures analysis|||CD3+ CD8+, Week 12||1.370|0.846|0.537
72422195|NCT02799472|144355233|OTHER||Ratio|1.032||||0.806|TWO_SIDED|95.0|0.797|1.335|||Repeated measures analysis|||CD3+ CD8+, 12-Week FU||1.335|0.797|0.806
72422196|NCT02799472|144355233|OTHER||Ratio|1.101||||0.405|TWO_SIDED|95.0|0.872|1.391|||Repeated measures analysis|||CD3+, Week 1||1.391|0.872|0.405
72422197|NCT02799472|144355233|OTHER||Ratio|0.907||||0.519|TWO_SIDED|95.0|0.668|1.232|||Repeated measures analysis|||CD3+, Week 4||1.232|0.668|0.519
72422198|NCT02799472|144355233|OTHER||Ratio|1.036||||0.748|TWO_SIDED|95.0|0.831|1.291|||Repeated measures analysis|||CD3+, Week 12||1.291|0.831|0.748
72422199|NCT02799472|144355233|OTHER||Ratio|1.049||||0.704|TWO_SIDED|95.0|0.811|1.356|||Repeated measures analysis|||CD3+, 12-Week FU||1.356|0.811|0.704
72330674|NCT02059499|144187301|EQUIVALENCE|Comparison of mean between count of hrHPV genotypes observed at baseline vs at week 20 in imiquimod arm||||||0.3||||||A priori threshold for interpreting significance : 0.05|Wilcoxon (Mann-Whitney)|||Comparison of number of hrHPV genotypes in each arm observed at baseline vs at week 20 in imiquimod arm||||0.3
72330675|NCT02059499|144187301|EQUIVALENCE|Comparison of mean number of hrHPV genotypes observed at baseline vs at week 20 in 5FU arm||||||0.3||||||A priori threshold to interpret significance: 0.05|Wilcoxon (Mann-Whitney)|||Comparison of the count of hrHPV genotypes observed at baseline vs at week 20 in 5FU arm||||0.3
72330676|NCT02059499|144187301|EQUIVALENCE|Comparison of mean number of hrHPV genotypes observed at baseline vs at week 20 in observation arm||||||0.26||||||A priori cutoff of significance: 0.05|Wilcoxon (Mann-Whitney)|||Comparison of the count of hrHPV genotypes observed at baseline vs at week 20 in observation arm||||0.26
72422200|NCT02799472|144355234|OTHER||Mean Difference (Net)|6.5||||0.501|TWO_SIDED|95.0|-13.1|26.1|||Repeated measures analysis|||CD3+CD4+CD25+CD127-, Week 1||26.1|-13.1|0.501
72422201|NCT02799472|144355234|OTHER||Mean Difference (Net)|-1.8||||0.852|TWO_SIDED|95.0|-21.6|18.0|||Repeated measures analysis|||CD3+CD4+CD25+CD127-, Week 4||18.0|-21.6|0.852
72422202|NCT02799472|144355234|OTHER||Mean Difference (Net)|6.3||||0.572|TWO_SIDED|95.0|-16.4|29.0|||Repeated measures analysis|||CD3+CD4+CD25+CD127-, Week 12||29.0|-16.4|0.572
72422203|NCT02799472|144355234|OTHER||Mean Difference (Net)|10.5||||0.363|TWO_SIDED|95.0|-13.0|34.1|||Repeated measures analysis|||CD3+CD4+CD25+CD127-, 12-Week FU||34.1|-13.0|0.363
72422204|NCT02799472|144355234|OTHER||Mean Difference (Net)|2.0||||0.788|TWO_SIDED|95.0|-13.0|17.0|||Repeated measures analysis|||CD3+CD4+foxP3+CD25+CD127-, Week 1||17.0|-13.0|0.788
72422205|NCT02799472|144355234|OTHER||Mean Difference (Net)|-2.2||||0.786|TWO_SIDED|95.0|-18.8|14.4|||Repeated measures analysis|||CD3+CD4+foxP3+CD25+CD127-, Week 4||14.4|-18.8|0.786
72422206|NCT02799472|144355234|OTHER||Mean Difference (Net)|-7.1||||0.433|TWO_SIDED|95.0|-25.4|11.2|||Repeated measures analysis|||CD3+CD4+foxP3+CD25+CD127-, Week 12||11.2|-25.4|0.433
72422207|NCT02799472|144355234|OTHER||Mean Difference (Net)|4.1||||0.55|TWO_SIDED|95.0|-9.8|18.0|||Repeated measures analysis|||CD3+CD4+foxP3+CD25+CD127-, 12-Week FU||18.0|-9.8|0.550
72422208|NCT02799472|144355235|OTHER||Mean Difference (Net)|14.6||||0.35|TWO_SIDED|95.0|-16.9|46.1|||Repeated measures analysis|||CD45+3+8-4+CCR6+CXCR3+38+DR+, Week 1||46.1|-16.9|0.350
72422209|NCT02799472|144355235|OTHER||Mean Difference (Net)|8.4||||0.697|TWO_SIDED|95.0|-35.3|52.0|||Repeated measures analysis|||CD45+3+8-4+CCR6+CXCR3+38+DR+, Week 4||52.0|-35.3|0.697
72422210|NCT02799472|144355235|OTHER||Mean Difference (Net)|-49.2||||0.249|TWO_SIDED|95.0|-135.2|36.8|||Repeated measures analysis|||CD45+3+8-4+CCR6+CXCR3+38+DR+, Week 12||36.8|-135.2|0.249
72422211|NCT02799472|144355235|OTHER||Mean Difference (Net)|-30.1||||0.119|TWO_SIDED|95.0|-68.6|8.3|||Repeated measures analysis|||CD45+3+8-4+CCR6+CXCR3+38+DR+, 12-Week FU||8.3|-68.6|0.119
72422212|NCT02799472|144355235|OTHER||Mean Difference (Net)|6.5||||0.403|TWO_SIDED|95.0|-9.3|22.4|||Repeated measures analysis|||CD45+3+8-4+CCR6+CXCR3-38+DR+, Week 1||22.4|-9.3|0.403
72422213|NCT02799472|144355235|OTHER||Mean Difference (Net)|-2.1||||0.91|TWO_SIDED|95.0|-39.4|35.2|||Repeated measures analysis|||CD45+3+8-4+CCR6+CXCR3-38+DR+, Week 4||35.2|-39.4|0.910
72422214|NCT02799472|144355235|OTHER||Mean Difference (Net)|-6.5||||0.718|TWO_SIDED|95.0|-43.1|30.1|||Repeated measures analysis|||CD45+3+8-4+CCR6+CXCR3-38+DR+, Week 12||30.1|-43.1|0.718
72422215|NCT02799472|144355235|OTHER||Mean Difference (Net)|-5.7||||0.687|TWO_SIDED|95.0|-34.4|23.0|||Repeated measures analysis|||CD45+3+8-4+CCR6+CXCR3-38+DR+, 12-Week FU||23.0|-34.4|0.687
72330677|NCT01751906|144187367|SUPERIORITY|||||||0.9256|||||||Chi-squared|||||||0.9256
72330678|NCT01751906|144187368|SUPERIORITY|||||||0.504|||||||Fisher Exact|||||||0.5040
72330679|NCT01751906|144187369|SUPERIORITY|||||||0.2126|||||||Fisher Exact|||||||0.2126
72330680|NCT01751906|144187396|SUPERIORITY|||||||0.0665|||||||Chi-squared|||||||0.0665
72422216|NCT02799472|144355235|OTHER||Mean Difference (Net)|-56.0||||0.559|TWO_SIDED|95.0|-249.8|137.7|||Repeated measures analysis|||CD45+3+8-4+CCR6-CXCR3+38+DR+, Week 1||137.7|-249.8|0.559
72422217|NCT02799472|144355235|OTHER||Mean Difference (Net)|51.6||||0.47|TWO_SIDED|95.0|-93.9|197.0|||Repeated measures analysis|||CD45+3+8-4+CCR6-CXCR3+38+DR+, Week 4||197.0|-93.9|0.470
72422218|NCT02799472|144355235|OTHER||Mean Difference (Net)|-141.5||||0.675|TWO_SIDED|95.0|-829.2|546.3|||Repeated measures analysis|||CD45+3+8-4+CCR6-CXCR3+38+DR+, Week 12||546.3|-829.2|0.675
72422219|NCT02799472|144355235|OTHER||Mean Difference (Net)|-137.9||||0.08|TWO_SIDED|95.0|-294.0|18.2|||Repeated measures analysis|||CD45+3+8-4+CCR6-CXCR3+38+DR+, 12-Week FU||18.2|-294.0|0.080
72422220|NCT02799472|144355235|OTHER||Mean Difference (Net)|0.4||||0.989|TWO_SIDED|95.0|-60.5|61.3|||Repeated measures analysis|||CD45+3+8-4+CCR6-CXCR3-38+DR+, Week 1||61.3|-60.5|0.989
72422221|NCT02799472|144355235|OTHER||Mean Difference (Net)|-17.4||||0.634|TWO_SIDED|95.0|-94.3|59.6|||Repeated measures analysis|||CD45+3+8-4+CCR6-CXCR3-38+DR+, Week 4||59.6|-94.3|0.634
72422222|NCT02799472|144355235|OTHER||Mean Difference (Net)|59.4||||0.789|TWO_SIDED|95.0|-395.2|513.9|||Repeated measures analysis|||CD45+3+8-4+CCR6-CXCR3-38+DR+, Week 12||513.9|-395.2|0.789
72422223|NCT02799472|144355235|OTHER||Mean Difference (Net)|-47.2||||0.249|TWO_SIDED|95.0|-135.5|41.0|||Repeated measures analysis|||CD45+3+8-4+CCR6-CXCR3-38+DR+, 12-Week FU||41.0|-135.5|0.249
72422224|NCT02799472|144355235|OTHER||Mean Difference (Net)|3682.3||||0.234|TWO_SIDED|95.0|-2511.9|9876.5|||Repeated measures analysis|||CD45+CD3+CD8-CD4+, Week 1||9876.5|-2511.9|0.234
72422225|NCT02799472|144355235|OTHER||Mean Difference (Net)|-547.6||||0.875|TWO_SIDED|95.0|-7612.6|6517.3|||Repeated measures analysis|||CD45+CD3+CD8-CD4+, Week 4||6517.3|-7612.6|0.875
72422226|NCT02799472|144355235|OTHER||Mean Difference (Net)|-1106.0||||0.815|TWO_SIDED|95.0|-10706.0|8494.1|||Repeated measures analysis|||CD45+CD3+CD8-CD4+, Week 12||8494.1|-10706.0|0.815
72368910|NCT04730271|144247541|SUPERIORITY|||||||0.8154|||||||t-test, 2 sided|||T-test P-value for difference in change from baseline between ROBOTIC and MANUAL at 12 weeks||||0.8154
72422227|NCT02799472|144355235|OTHER||Mean Difference (Net)|-3631.0||||0.23|TWO_SIDED|95.0|-9738.9|2476.8|||Repeated measures analysis|||CD45+CD3+CD8-CD4+, 12-Week FU||2476.8|-9738.9|0.230
72422228|NCT02799472|144355235|OTHER||Mean Difference (Net)|-515.6||||0.489|TWO_SIDED|95.0|-2021.4|990.1|||Repeated measures analysis|||CD45+CD3+CD8-CD4+CCR6+CXCR3+, Week 1||990.1|-2021.4|0.489
72422229|NCT02799472|144355235|OTHER||Mean Difference (Net)|-199.8||||0.822|TWO_SIDED|95.0|-2001.7|1602.0|||Repeated measures analysis|||CD45+CD3+CD8-CD4+CCR6+CXCR3+, Week 4||1602.0|-2001.7|0.822
72422230|NCT02799472|144355235|OTHER||Mean Difference (Net)|-253.5||||0.784|TWO_SIDED|95.0|-2136.7|1629.7|||Repeated measures analysis|||CD45+CD3+CD8-CD4+CCR6+CXCR3+, Week 12||1629.7|-2136.7|0.784
72422231|NCT02799472|144355235|OTHER||Mean Difference (Net)|225.1||||0.804|TWO_SIDED|95.0|-1633.1|2083.2|||Repeated measures analysis|||CD45+CD3+CD8-CD4+CCR6+CXCR3+, 12-Week FU||2083.2|-1633.1|0.804
72422232|NCT02799472|144355235|OTHER||Mean Difference (Net)|162.7||||0.719|TWO_SIDED|95.0|-754.5|1079.9|||Repeated measures analysis|||CD45+CD3+CD8-CD4+CCR6+CXCR3-, Week 1||1079.9|-754.5|0.719
72422233|NCT02799472|144355235|OTHER||Mean Difference (Net)|-183.5||||0.742|TWO_SIDED|95.0|-1317.4|950.3|||Repeated measures analysis|||CD45+CD3+CD8-CD4+CCR6+CXCR3-, Week 4||950.3|-1317.4|0.742
72422234|NCT02799472|144355235|OTHER||Mean Difference (Net)|-268.5||||0.658|TWO_SIDED|95.0|-1507.5|970.5|||Repeated measures analysis|||CD45+CD3+CD8-CD4+CCR6+CXCR3-, Week 12||970.5|-1507.5|0.658
72422235|NCT02799472|144355235|OTHER||Mean Difference (Net)|-197.6||||0.755|TWO_SIDED|95.0|-1499.3|1104.2|||Repeated measures analysis|||CD45+CD3+CD8-CD4+CCR6+CXCR3-, 12-Week FU||1104.2|-1499.3|0.755
72422236|NCT02799472|144355235|OTHER||Mean Difference (Net)|1150.0||||0.333|TWO_SIDED|95.0|-1250.0|3550.0|||Repeated measures analysis|||CD45+CD3+CD8-CD4+CCR6-CXCR3+, Week 1||3550.0|-1250.0|0.333
72422237|NCT02799472|144355235|OTHER||Mean Difference (Net)|-268.0||||0.891|TWO_SIDED|95.0|-4269.2|3733.3|||Repeated measures analysis|||CD45+CD3+CD8-CD4+CCR6-CXCR3+, Week 4||3733.3|-4269.2|0.891
72422238|NCT02799472|144355235|OTHER||Mean Difference (Net)|-1347.4||||0.633|TWO_SIDED|95.0|-7073.1|4378.3|||Repeated measures analysis|||CD45+CD3+CD8-CD4+CCR6-CXCR3+, Week 12||4378.3|-7073.1|0.633
72422239|NCT02799472|144355235|OTHER||Mean Difference (Net)|-1688.9||||0.41|TWO_SIDED|95.0|-5864.1|2486.2|||Repeated measures analysis|||CD45+CD3+CD8-CD4+CCR6-CXCR3+, 12-Week FU||2486.2|-5864.1|0.410
72422240|NCT02799472|144355235|OTHER||Mean Difference (Net)|3276.8||||0.196|TWO_SIDED|95.0|-1786.0|8339.6|||Repeated measures analysis|||CD45+CD3+CD8-CD4+CCR6-CXCR3-, Week 1||8339.6|-1786.0|0.196
72422241|NCT02799472|144355235|OTHER||Mean Difference (Net)|-447.3||||0.894|TWO_SIDED|95.0|-7285.5|6390.8|||Repeated measures analysis|||CD45+CD3+CD8-CD4+CCR6-CXCR3-, Week 4||6390.8|-7285.5|0.894
72422242|NCT02799472|144355235|OTHER||Mean Difference (Net)|1435.3||||0.6|TWO_SIDED|95.0|-4101.4|6972.0|||Repeated measures analysis|||CD45+CD3+CD8-CD4+CCR6-CXCR3-, Week 12||6972.0|-4101.4|0.600
72422243|NCT02799472|144355235|OTHER||Mean Difference (Net)|-1210.2||||0.534|TWO_SIDED|95.0|-5213.1|2792.7|||Repeated measures analysis|||CD45+CD3+CD8-CD4+CCR6-CXCR3-, 12-Week FU||2792.7|-5213.1|0.534
72422244|NCT02799472|144355236|OTHER||Mean Difference (Net)|2756.3||||0.328|TWO_SIDED|95.0|-2953.7|8466.3|||Repeated measures analysis|||CD14-HLA-DR+CD11cbr+CD123-, Week 1||8466.3|-2953.7|0.328
72422245|NCT02799472|144355236|OTHER||Mean Difference (Net)|-487.5||||0.895|TWO_SIDED|95.0|-8003.7|7028.6|||Repeated measures analysis|||CD14-HLA-DR+CD11cbr+CD123-, Week 4||7028.6|-8003.7|0.895
72422246|NCT02799472|144355236|OTHER||Mean Difference (Net)|-277.4||||0.961|TWO_SIDED|95.0|-12001.0|11446.2|||Repeated measures analysis|||CD14-HLA-DR+CD11cbr+CD123-, Week 12||11446.2|-12001.0|0.961
72422247|NCT02799472|144355236|OTHER||Mean Difference (Net)|-311.6||||0.956|TWO_SIDED|95.0|-11960.5|11337.4|||Repeated measures analysis|||CD14-HLA-DR+CD11cbr+CD123-, 12-Week FU||11337.4|-11960.5|0.956
72422248|NCT02799472|144355236|OTHER||Mean Difference (Net)|6866.9||||0.212|TWO_SIDED|95.0|-4230.7|17964.6|||Repeated measures analysis|||CD14br+CD16+, Week 1||17964.6|-4230.7|0.212
72422249|NCT02799472|144355236|OTHER||Mean Difference (Net)|8359.6||||0.227|TWO_SIDED|95.0|-5533.3|22252.5|||Repeated measures analysis|||CD14br+CD16+, Week 4||22252.5|-5533.3|0.227
72422250|NCT02799472|144355236|OTHER||Mean Difference (Net)|-22683.6||||0.04|TWO_SIDED|95.0|-44298.5|-1068.8|||Repeated measures analysis|||CD14br+CD16+, Week 12||-1068.8|-44298.5|0.040
72422251|NCT02799472|144355236|OTHER||Mean Difference (Net)|-3757.2||||0.741|TWO_SIDED|95.0|-27146.0|19631.6|||Repeated measures analysis|||CD14br+CD16+, 12-Week FU||19631.6|-27146.0|0.741
72422252|NCT02799472|144355236|OTHER||Mean Difference (Net)|-22417.0||||0.628|TWO_SIDED|95.0|-116677.8|71843.8|||Repeated measures analysis|||CD14br+CD16-, Week 1||71843.8|-116677.8|0.628
72422253|NCT02799472|144355236|OTHER||Mean Difference (Net)|27659.7||||0.321|TWO_SIDED|95.0|-28567.8|83887.1|||Repeated measures analysis|||CD14br+CD16-, Week 4||83887.1|-28567.8|0.321
72422254|NCT02799472|144355236|OTHER||Mean Difference (Net)|16182.9||||0.704|TWO_SIDED|95.0|-70377.0|102742.9|||Repeated measures analysis|||CD14br+CD16-, Week 12||102742.9|-70377.0|0.704
72422255|NCT02799472|144355236|OTHER||Mean Difference (Net)|-63419.4||||0.232|TWO_SIDED|95.0|-170364.9|43526.1|||Repeated measures analysis|||CD14br+CD16-, 12-Week FU||43526.1|-170364.9|0.232
72422256|NCT02799472|144355236|OTHER||Mean Difference (Net)|-6913.6||||0.366|TWO_SIDED|95.0|-22588.4|8761.1|||Repeated measures analysis|||CD14lo+CD16br+, Week 1||8761.1|-22588.4|0.366
72422257|NCT02799472|144355236|OTHER||Mean Difference (Net)|-2231.6||||0.603|TWO_SIDED|95.0|-10976.8|6513.6|||Repeated measures analysis|||CD14lo+CD16br+, Week 4||6513.6|-10976.8|0.603
72422258|NCT02799472|144355236|OTHER||Mean Difference (Net)|-10179.1||||0.084|TWO_SIDED|95.0|-21827.4|1469.2|||Repeated measures analysis|||CD14lo+CD16br+, Week 12||1469.2|-21827.4|0.084
72422259|NCT02799472|144355236|OTHER||Mean Difference (Net)|-20744.2||||0.026|TWO_SIDED|95.0|-38771.8|-2716.5|||Repeated measures analysis|||CD14lo+CD16br+, 12-Week FU||-2716.5|-38771.8|0.026
72422260|NCT02799472|144355237|OTHER||Mean Difference (Net)|178.2||||0.564|TWO_SIDED|95.0|-448.3|804.6|||Repeated measures analysis|||Week 1||804.6|-448.3|0.564
72422261|NCT02799472|144355237|OTHER||Mean Difference (Net)|540.4||||0.216|TWO_SIDED|95.0|-335.7|1416.5|||Repeated measures analysis|||Week 4||1416.5|-335.7|0.216
72422262|NCT02799472|144355237|OTHER||Mean Difference (Net)|-252.6||||0.629|TWO_SIDED|95.0|-1326.0|820.8|||Repeated measures analysis|||Week 12||820.8|-1326.0|0.629
72422263|NCT02799472|144355237|OTHER||Mean Difference (Net)|41.6||||0.932|TWO_SIDED|95.0|-962.2|1045.5|||Repeated measures analysis|||12-Week FU||1045.5|-962.2|0.932
72422264|NCT02799472|144355245|OTHER||Median Difference (Net)|-0.13||||0.547|TWO_SIDED|95.0|-2.32|2.23|||Repeated Measures Bayesian Model|||Week 4, For Posterior Probability Difference \<0||2.23|-2.32|0.547
72422265|NCT02799472|144355245|OTHER||Median Difference (Net)|-2.18||||0.948|TWO_SIDED|95.0|-4.77|0.51|||Repeated Measures Bayesian Model|||Week 12, For Posterior Probability Difference \<0||0.51|-4.77|0.948
72422266|NCT02799472|144355245|OTHER||Median Difference (Net)|-2.28||||0.949|TWO_SIDED|95.0|-5.02|0.45|||Repeated Measures Bayesian Model|||12-Week FU, For Posterior Probability Difference \<0||0.45|-5.02|0.949
72422267|NCT02799472|144355245|OTHER||Median Difference (Net)|-0.13||||0.453|TWO_SIDED|95.0|-2.32|2.23|||Repeated Measures Bayesian Model|||Week 4, For Posterior Probability Difference \>0||2.23|-2.32|0.453
72422268|NCT02799472|144355245|OTHER||Median Difference (Net)|-2.18||||0.052|TWO_SIDED|95.0|-4.77|0.51|||Repeated Measures Bayesian Model|||Week 12, For Posterior Probability Difference \>0||0.51|-4.77|0.052
72422269|NCT02799472|144355245|OTHER||Median Difference (Net)|-2.28||||0.051|TWO_SIDED|95.0|-5.02|0.45|||Repeated Measures Bayesian Model|||12-Week FU, For Posterior Probability Difference \>0||0.45|-5.02|0.051
72422270|NCT02799472|144355246|OTHER||Mean Difference (Net)|0.0||||0.94|TWO_SIDED|95.0|-0.2|0.3|||Repeated measures analysis|||Week 4||0.3|-0.2|0.940
72422271|NCT02799472|144355246|OTHER||Mean Difference (Net)|-0.8||||0.521|TWO_SIDED|95.0|-3.2|1.6|||Repeated measures analysis|||Week 12||1.6|-3.2|0.521
72422272|NCT02799472|144355246|OTHER||Mean Difference (Net)|-1.3||||0.396|TWO_SIDED|95.0|-4.4|1.8|||Repeated measures analysis|||12-Week FU||1.8|-4.4|0.396
72422273|NCT02799472|144355247|OTHER||Mean Difference (Net)|0.0||||0.945|TWO_SIDED|95.0|-1.1|1.2|||Repeated measures analysis|||Week 4||1.2|-1.1|0.945
72422274|NCT02799472|144355247|OTHER||Mean Difference (Net)|-0.4||||0.475|TWO_SIDED|95.0|-1.5|0.7|||Repeated measures analysis|||Week 12||0.7|-1.5|0.475
72422275|NCT02799472|144355247|OTHER||Mean Difference (Net)|-0.9||||0.086|TWO_SIDED|95.0|-2.0|0.1|||Repeated measures analysis|||12-Week FU||0.1|-2.0|0.086
72422276|NCT02799472|144355248|OTHER||Mean Difference (Net)|211.4||||0.874|TWO_SIDED|95.0|-2589.2|3012.0|||Repeated measures analysis|||Week 4||3012.0|-2589.2|0.874
72422277|NCT02799472|144355248|OTHER||Mean Difference (Net)|-504.8||||0.749|TWO_SIDED|95.0|-3730.4|2720.9|||Repeated measures analysis|||Week 12||2720.9|-3730.4|0.749
72422278|NCT02799472|144355248|OTHER||Mean Difference (Net)|-1536.0||||0.352|TWO_SIDED|95.0|-4884.2|1812.1|||Repeated measures analysis|||12-Week FU||1812.1|-4884.2|0.352
72422279|NCT02799472|144355249|OTHER||Mean Difference (Net)|0.0128||||0.291|TWO_SIDED|95.0|-0.0123|0.038|||Repeated measures analysis|||Week 4||0.0380|-0.0123|0.291
72422280|NCT02799472|144355249|OTHER||Mean Difference (Net)|0.0036||||0.375|TWO_SIDED|95.0|-0.0046|0.0118|||Repeated measures analysis|||Week 12||0.0118|-0.0046|0.375
72422281|NCT02799472|144355249|OTHER||Mean Difference (Net)|0.001||||0.588|TWO_SIDED|95.0|-0.0028|0.0049|||Repeated measures analysis|||12-Week FU||0.0049|-0.0028|0.588
72422282|NCT02799472|144355250|OTHER||Mean Difference (Net)|-0.0002||||0.915|TWO_SIDED|95.0|-0.0033|0.0029|||Repeated measures analysis|||Week 4||0.0029|-0.0033|0.915
72422283|NCT02799472|144355250|OTHER||Mean Difference (Net)|-0.0004||||0.771|TWO_SIDED|95.0|-0.0028|0.0021|||Repeated measures analysis|||Week 12||0.0021|-0.0028|0.771
72422284|NCT02799472|144355250|OTHER||Mean Difference (Net)|0.0005||||0.85|TWO_SIDED|95.0|-0.0048|0.0058|||Repeated measures analysis|||12-Week FU||0.0058|-0.0048|0.850
72422285|NCT00674570|144355251|SUPERIORITY||Mean Difference (Net)|-0.02|STANDARD_ERROR_OF_MEAN|0.06|=|0.66|TWO_SIDED|95.0|-0.15|0.1|||Mixed Models Analysis|||Fear Conditioning Beginning (first trial)||.10|-.15|=.66
72422286|NCT00674570|144355251|SUPERIORITY||Mean Difference (Net)|-0.05|STANDARD_ERROR_OF_MEAN|0.06|=|0.41|TWO_SIDED|95.0|-0.17|0.07|||Mixed Models Analysis|||Fear Conditioning Beginning (first trial)||.07|-.17|=.41
72422287|NCT00674570|144355251|SUPERIORITY||Median Difference (Net)|0.05|STANDARD_ERROR_OF_MEAN|0.06|=|0.43|TWO_SIDED|95.0|-0.07|0.18|||Mixed Models Analysis|||Fear Conditioning End (last trial)||.18|-.07|=.43
72422288|NCT00674570|144355251|SUPERIORITY||Median Difference (Net)|0.04|STANDARD_ERROR_OF_MEAN|0.06|=|0.47|TWO_SIDED|95.0|-0.07|0.17|||Mixed Models Analysis|||Fear Conditioning End (last trial)||.17|-.07|=.47
72422289|NCT00674570|144355251|SUPERIORITY||Mean Difference (Net)|0.09|STANDARD_ERROR_OF_MEAN|0.05|=|0.065|TWO_SIDED|95.0|-0.01|0.2|||Mixed Models Analysis|||Fear Extinction Beginning (first trial)||.20|-.01|=.065
72330681|NCT01460875|144187427|NON_INFERIORITY|The method to be developed will allow us to declare that a response at a lower dose is not inferior to that at the standard dose for a particular patient, using a patient specific inferiority test.||||||0.22|||||||Wilcoxon (Mann-Whitney)|||||||.22
72330682|NCT02150057|144187446|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<0.05
72330683|NCT00394251|144187457|SUPERIORITY_OR_OTHER_LEGACY|||||||0.641|||||||Fisher Exact|||Comparison of percentage of participants with at least one taxane-emergent toxicity||||0.641
72330684|NCT00394251|144187463|SUPERIORITY_OR_OTHER_LEGACY|||||||0.323||95.0|||||Fisher Exact|||Comparison of percentage of participants with at least one taxane-emergent toxicity||||0.323
72330685|NCT01696994|144187469|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.99|||||TWO_SIDED|95.0|0.95|1.04|||Poisson regression|Two-sided. Not adjusted for multiple comparisons. A-priori threshold for significance 0.05.||||1.04|0.95|
72330686|NCT01696994|144187471|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.21|||||TWO_SIDED|95.0|0.99|1.48|||Poisson regression|||||1.48|0.99|
72330687|NCT01696994|144187481|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.18|||||TWO_SIDED|95.0|0.91|1.54||Two-sided. Not adjusted for multiple comparisons. A-priori threshold for significance 0.05.|Poisson regression|||||1.54|.91|
72330688|NCT04644276|144187486|SUPERIORITY||Median Difference (Final Values)|-37.0|STANDARD_DEVIATION|102.0||0.8125|TWO_SIDED|95.0|-112.6|140.7|||Wilcoxon Signed-Ranks test||Unit is percent change.|Percent change in leak 100% x (\[Mask with mask adhesive\] - \[Mask without mask adhesive\])/ \[Mask without mask adhesive\]. The comparison between the two arms is captured in the reported percentage change.||140.7|-112.6|0.8125
72330689|NCT01951586|144187504|SUPERIORITY||Hazard Ratio (HR)|1.11||||0.5157|TWO_SIDED|95.0|0.81|1.53|||Log Rank|Log rank test stratified by the randomization stratification factors.|"Based on a Cox proportional hazards model stratified by the randomized stratification factors.~Hazard ratio \< 1 favors denosumab."|||1.53|0.81|0.5157
72330690|NCT01951586|144187505|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3759|||||||Cox propotional hazard model|||The interaction of RANK expression level measured in the cytoplasm (all intensity) and treatment effect was evaluated using a Cox proportional hazard model that included treatment group, RANK expression level and treatment-by-RANK expression level interaction stratified by the randomization stratification factors.||||0.3759
72330691|NCT01951586|144187505|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3666|||||||Cox propotional hazard model|||The interaction of RANK expression level measured in membranes (all intensity) and treatment effect was evaluated using a Cox proportional hazard model that included treatment group, RANK expression level and treatment-by-RANK expression level interaction stratified by the randomization stratification factors.||||0.3666
72330692|NCT01951586|144187505|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1917|||||||Cox propotional hazard model|||The interaction of RANK expression level total (cytoplasm + membranes; all intensity) and treatment effect was evaluated using a Cox proportional hazard model that included treatment group, RANK expression level and treatment-by-RANK expression level interaction stratified by the randomization stratification factors.||||0.1917
72330693|NCT01951586|144187505|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3353|||||||Cox propotional hazard model|||The interaction of RANK expression level measured in the cytoplasm (H-score) and treatment effect was evaluated using a Cox proportional hazard model that included treatment group, RANK expression level and treatment-by-RANK expression level interaction stratified by the randomization stratification factors.||||0.3353
72330694|NCT01951586|144187505|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3179|||||||Cox propotional hazard model|||The interaction of RANK expression level measured in membranes (H-score) and treatment effect was evaluated using a Cox proportional hazard model that included treatment group, RANK expression level and treatment-by-RANK expression level interaction stratified by the randomization stratification factors.||||0.3179
72330695|NCT01951586|144187505|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1583|||||||Cox propotional hazard model|||The interaction of RANK expression level total (cytoplasm + membranes; H-score) and treatment effect was evaluated using a Cox proportional hazard model that included treatment group, RANK expression level and treatment-by-RANK expression level interaction stratified by the randomization stratification factors.||||0.1583
72368911|NCT04730271|144247542|SUPERIORITY|||||||0.0165|||||||t-test, 2 sided|||Comparison of FJS at 12 weeks||||0.0165
72368912|NCT04730271|144247542|SUPERIORITY|||||||0.1331|||||||t-test, 2 sided|||Comparison of FJS at 1 year||||0.1331
72368913|NCT04730271|144247543|SUPERIORITY|||||||0.1596|||||||t-test, 2 sided|||T-test P-value for difference in change from baseline between ROBOTIC and MANUAL at 1 year||||0.1596
72368914|NCT04730271|144247543|SUPERIORITY|||||||0.6834|||||||t-test, 2 sided|||T-test P-value for difference in change from baseline between ROBOTIC and MANUAL at 12 weeks||||0.6834
72368915|NCT04730271|144247544|SUPERIORITY|||||||0.5675|||||||t-test, 2 sided|||T-test P-value for difference in change from baseline between ROBOTIC and MANUAL at 1 year||||0.5675
72368916|NCT04730271|144247544|SUPERIORITY|||||||0.924|||||||t-test, 2 sided|||T-test P-value for difference in change from baseline between ROBOTIC and MANUAL at 12 weeks||||0.9240
72368917|NCT04730271|144247545|SUPERIORITY|||||||0.4586|||||||t-test, 2 sided|||T-test P-value for difference in change from baseline between ROBOTIC and MANUAL at 1 year||||0.4586
72368918|NCT04730271|144247545|SUPERIORITY|||||||0.6951|||||||t-test, 2 sided|||T-test P-value for difference in change from baseline between ROBOTIC and MANUAL at 12 weeks||||0.6951
72368919|NCT04730271|144247546|SUPERIORITY|||||||0.8|||||||t-test, 2 sided|||T-test P-value for difference in change from baseline between ROBOTIC and MANUAL at 1 year||||0.8000
72330696|NCT01951586|144187506|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3946|||||||Cox propotional hazard model|||The interaction of RANKL expression level measured in the cytoplasm (all intensity) and treatment effect was evaluated using a Cox proportional hazard model that included treatment group, RANKL expression level and treatment-by-RANKL expression level interaction stratified by the randomization stratification factors.||||0.3946
72330697|NCT01951586|144187506|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3735|||||||Cox propotional hazard model|||The interaction of RANKL expression level measured in the cytoplasm (H-score) and treatment effect was evaluated using a Cox proportional hazard model that included treatment group, RANKL expression level and treatment-by-RANKL expression level interaction stratified by the randomization stratification factors.||||0.3735
72330698|NCT01951586|144187507|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.76||||0.3491|TWO_SIDED|95.0|0.43|1.35|||Regression, Logistic|Logistic regression model adjusted for the randomization stratification factors.|Based on a logistic regression model adjusted for the randomization stratification factors; an odds ratio ≥ 1 favors denosumab.|||1.35|0.43|0.3491
72330699|NCT01951586|144187508|SUPERIORITY_OR_OTHER_LEGACY|||||||0.476|||||||Regression, Logistic|||The interaction of RANK expression level measured in the cytoplasm (all intensity) and treatment effect was evaluated using a logistic regression model that included treatment group, RANK expression level and treatment-by-RANK expression level interaction stratified by the randomization stratification factors.||||0.4760
72330700|NCT01951586|144187508|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2582|||||||Regression, Logistic|||The interaction of RANK expression level measured in the membranes (all intensity) and treatment effect was evaluated using a logistic regression model that included treatment group, RANK expression level and treatment-by-RANK expression level interaction stratified by the randomization stratification factors.||||0.2582
72330701|NCT01951586|144187508|SUPERIORITY_OR_OTHER_LEGACY|||||||0.223|||||||Regression, Logistic|||The interaction of RANK expression level total (cytoplasm + membrane; all intensity) and treatment effect was evaluated using a logistic regression model that included treatment group, RANK expression level and treatment-by-RANK expression level interaction stratified by the randomization stratification factors.||||0.2230
72330702|NCT01951586|144187508|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4329|||||||Regression, Logistic|||The interaction of RANK expression level measured in the cytoplasm (H-score) and treatment effect was evaluated using a logistic regression model that included treatment group, RANK expression level and treatment-by-RANK expression level interaction stratified by the randomization stratification factors.||||0.4329
72330703|NCT01951586|144187508|SUPERIORITY_OR_OTHER_LEGACY|||||||0.262|||||||Regression, Logistic|||The interaction of RANK expression level measured in the membranes (H-score) and treatment effect was evaluated using a logistic regression model that included treatment group, RANK expression level and treatment-by-RANK expression level interaction stratified by the randomization stratification factors.||||0.2620
72330704|NCT01951586|144187508|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2081|||||||Regression, Logistic|||The interaction of RANK expression level total (cytoplasm + membrane; H-score) and treatment effect was evaluated using a logistic regression model that included treatment group, RANK expression level and treatment-by-RANK expression level interaction stratified by the randomization stratification factors.||||0.2081
72330705|NCT01951586|144187509|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4671|||||||Regression, Logistic|||The interaction of RANKL expression level measured in the cytoplasm (all intensity) and treatment effect was evaluated using a logistic regression model that included treatment group, RANKL expression level and treatment-by-RANKL expression level interaction stratified by the randomization stratification factors.||||0.4671
72330706|NCT01951586|144187509|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4236|||||||Regression, Logistic|||The interaction of RANKL expression level measured in the cytoplasm (H-score) and treatment effect was evaluated using a logistic regression model that included treatment group, RANKL expression level and treatment-by-RANKL expression level interaction stratified by the randomization stratification factors.||||0.4236
72368920|NCT04730271|144247546|SUPERIORITY|||||||0.973|||||||t-test, 2 sided|||T-test P-value for difference in change from baseline between ROBOTIC and MANUAL at 12 weeks||||0.9730
72368921|NCT04730271|144247547|SUPERIORITY|||||||0.4636|||||||t-test, 2 sided|||T-test P-value for difference in change from baseline between ROBOTIC and MANUAL at 1 year||||0.4636
72368922|NCT04730271|144247547|SUPERIORITY|||||||0.8088|||||||t-test, 2 sided|||T-test P-value for difference in change from baseline between ROBOTIC and MANUAL at 12 weeks||||0.8088
72368923|NCT04730271|144247548|SUPERIORITY|||||||0.4851|||||||t-test, 2 sided|||T-Test P-value tests the significance of the difference between ROBOTIC and MANUAL at 12 weeks||||0.4851
72368924|NCT04730271|144247548|SUPERIORITY|||||||0.6486|||||||t-test, 2 sided|||T-Test P-value tests the significance of the difference between ROBOTIC and MANUAL at 1 year||||0.6486
72422290|NCT00674570|144355251|SUPERIORITY||Mean Difference (Net)|0.05|STANDARD_ERROR_OF_MEAN|0.05|=|0.34|TWO_SIDED|95.0|-0.05|0.15|||Mixed Models Analysis|||Fear Extinction Beginning (first trial)||.15|-.05|=.34
72422291|NCT00674570|144355251|SUPERIORITY||Mean Difference (Net)|0.16|STANDARD_ERROR_OF_MEAN|0.05|=|0.003|TWO_SIDED|95.0|0.06|0.26|||Mixed Models Analysis|||Extinction End (last trial)||.26|.06|=.003
72330707|NCT01951586|144187510|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.81||||0.4654|TWO_SIDED|95.0|0.46|1.43|||Regression, Logistic|Logistic regression model adjusted for the randomization stratification factors.|Based on a logistic regression model adjusted for the randomization stratification factors; an odds ratio ≥ 1 favors denosumab.|||1.43|0.46|0.4654
72330708|NCT01951586|144187511|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.05||||0.7363|TWO_SIDED|95.0|0.78|1.43|||Log Rank|Log rank test stratified by the randomized stratification factors.|"Based on a Cox proportional hazards model stratified by the randomized stratification factors.~Hazard ratio \< 1 favors denosumab."|||1.43|0.78|0.7363
72330709|NCT01667224|144187523|NON_INFERIORITY_OR_EQUIVALENCE|Data are present as the mean±S.E. to detect a 0.3kg(S.D.=0.6kg) difference in body weight between groups with 80% power and a two-tailed α-value of 0.05.|||||<|0.05|||||||Mixed Models Analysis|||Data are present as the mean±S.E. to detect a 0.3kg(S.D.=0.6kg) difference in body weight between groups with 80% power and a two-tailed α-value of 0.05.||||<0.05
72368925|NCT04730271|144247549|SUPERIORITY|||||||0.8887|||||||t-test, 2 sided|||T-test P-value for difference in change from baseline for Pain at rest between ROBOTIC and MANUAL at 1 year||||0.8887
72368926|NCT04730271|144247549|SUPERIORITY|||||||0.4007|||||||t-test, 2 sided|||T-test P-value for difference in change from baseline for pain at rest between ROBOTIC and MANUAL at 12 weeks||||0.4007
72422292|NCT00674570|144355251|SUPERIORITY||Mean Difference (Net)|0.12|STANDARD_ERROR_OF_MEAN|0.05||0.02|TWO_SIDED|95.0|0.02|0.22|||Mixed Models Analysis|||Extinction End (last trial)||.22|.02|.02
72330710|NCT01667224|144187524|NON_INFERIORITY_OR_EQUIVALENCE|Data are present as the mean±S.D. to detect a 0.3kg(S.E.=0.6kg) difference in body weight between groups with 80% power and a two-tailed α-value of 0.05.|||||<|0.05|||||||Mixed Models Analysis|||Data are present as the mean±S.D. to detect a 0.3kg(S.E.=0.6kg) difference in body weight between groups with 80% power and a two-tailed α-value of 0.05.||||<0.05
72330711|NCT01667224|144187525|NON_INFERIORITY_OR_EQUIVALENCE|Data are present as the mean±S.D. to detect a 0.3kg(S.E.=0.6kg) difference in body weight between groups with 80% power and a two-tailed α-value of 0.05.|||||<|0.05|||||||Mixed Models Analysis|||Data are present as the mean±S.D. to detect a 0.3kg(S.E.=0.6kg) difference in body weight between groups with 80% power and a two-tailed α-value of 0.05.||||<0.05
72330712|NCT01667224|144187526|NON_INFERIORITY_OR_EQUIVALENCE|Data are present as the mean±S.E. to detect a 0.3kg(S.D.=0.60kg) difference in body weight between groups with 80% power and a two-tailed α-value of 0.05.|||||<|0.05|||||||Mixed Models Analysis|||Data are present as the mean±S.E. to detect a 0.3kg(S.D.=0.60kg) difference in body weight between groups with 80% power and a two-tailed α-value of 0.05.||||<0.05
72330713|NCT02752633|144187574|OTHER||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||Data are presented as the urinary DHA excretion (mg/24 hr) and as the DHA-to-creatinine ratio (mg/mmol) in first morning void urine samples. Data are presented as a median (range). Differences in the median urinary DHA excretion and the urinary DHA-to-creatinine ratio between periods off pharmacotherapy and on the two study drugs, febuxostat and allopurinol, were assessed using the Wilcoxon signed rank test.||||<.05
72330714|NCT01988662|144187602|NON_INFERIORITY_OR_EQUIVALENCE|"H0: There is no difference in the percent change in VEGF level after 3 months for patients with nAMD treated with ranibizumab compared to aflibercept.~HA: There is a difference in the percent change in VEGF level after 3 months for patients with nAMD treated with ranibizumab compared to aflibercept."|Mean Difference (Net)|62.57|STANDARD_ERROR_OF_MEAN|24.639||0.012|TWO_SIDED|95.0|13.96|111.17|||Mixed Models Analysis|||H0: μR = μA versus HA: μR ≠ μA||111.17|13.96|0.012
72330715|NCT00842153|144187609|SUPERIORITY_OR_OTHER|||||||0.1269||95.0||||P-value for Week 1|Fisher Exact|||||||0.1269
72330716|NCT00842153|144187609|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||P-value for Week 2|Chi-squared|||||||<0.0001
72330717|NCT00842153|144187609|SUPERIORITY_OR_OTHER|||||||0.0015||95.0||||P-value for Week 4|Chi-squared|||||||0.0015
72330718|NCT00002540|144187626|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.09|||||TWO_SIDED|95.0|0.87|1.36||Two-sided. Not adjusted for multiple comparisons. A-priori threshold for significance 0.05.|Poisson regression|||||1.36|0.87|
72330719|NCT00002540|144187628|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.96|||||TWO_SIDED|95.0|0.93|1.0|||Poisson regression|Two-sided. Not adjusted for multiple comparisons. A-priori threshold for significance 0.05.||||1.00|0.93|
72330720|NCT00002540|144187630|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.12|||||TWO_SIDED|95.0|1.07|1.17|||Poisson regression|Two-sided. Not adjusted for multiple comparisons. A-priori threshold for significance 0.05.||||1.17|1.07|
72330721|NCT00002540|144187640|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.09|||||TWO_SIDED|95.0|0.87|1.36|||Poisson regression|||||1.36|0.87|
72330722|NCT04445519|144187646|NON_INFERIORITY|Non-inferiority was concluded if the lower limit of the 95.1% CIs around the difference (NCX 470 minus latanoprost 0.005%) in mean IOP reduction from time-matched baseline in the study eye was greater than or equal to -1.5 mmHg at all time points and was greater than or equal to -1.0 mmHg at a majority of the time points.|Mean Difference (Net)|1.0|STANDARD_DEVIATION|3.25|||TWO_SIDED|95.1||||The primary efficacy assessment was the non-inferiority analysis of the difference in the treatment effect between NCX 470 and latanoprost 0.005% for mean IOP reduction from time-matched baseline at the 8AM and 4PM time-points.|||The analysis assumed a true difference of 1.0 mmHg at the Week 2 time points and 1.25 mmHg at the Week 6 and Month 3 time points; a common standard deviation (SD) at each time-point of 3.25 mmHg; and a two-sided significance level of 4.9%.|||||
72330723|NCT01345929|144187650|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower bound of the 2-sided 95% CI was greater than -10%.|Risk Difference (RD)|8.5|||||TWO_SIDED|95.0|2.31|14.57||||||||14.57|2.31|
72330724|NCT01345929|144187651|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower bound of the 2-sided 95% CI was greater than -10%.|Risk Difference (RD)|8.0|||||TWO_SIDED|95.0|1.95|13.97||||||||13.97|1.95|
72330725|NCT01500252|144187667|SUPERIORITY_OR_OTHER_LEGACY|||||||0.59||95.0|||||t-test, 2 sided|||||||0.59
72330726|NCT01500252|144187668|SUPERIORITY_OR_OTHER_LEGACY|||||||0.83||95.0|||||t-test, 2 sided|||||||0.83
72330727|NCT01500252|144187670|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1||95.0|||||t-test, 2 sided|||||||0.10
72330728|NCT01500252|144187671|SUPERIORITY_OR_OTHER_LEGACY|||||||0.39||95.0|||||t-test, 2 sided|||||||0.39
72330729|NCT01500252|144187672|SUPERIORITY_OR_OTHER_LEGACY|||||||0.43||95.0|||||t-test, 2 sided|||||||0.43
72422293|NCT00674570|144355251|OTHER||Mean Difference (Net)|0.18|STANDARD_ERROR_OF_MEAN|0.06|=|0.006|TWO_SIDED|95.0|0.05|0.3|||Mixed Models Analysis|||Extinction Retention (first 2 trials) First trials were selected as a test of extinction retention, since repeated presentations of the CS without a UCS were expected to result in additional fear extinction.||.30|.05|=.006
72330730|NCT01500252|144187673|SUPERIORITY_OR_OTHER_LEGACY|||||||0.71||95.0|||||t-test, 2 sided|||||||0.71
72330731|NCT01500252|144187674|SUPERIORITY_OR_OTHER_LEGACY|||||||0.98||95.0|||||t-test, 2 sided|||||||0.98
72422294|NCT00674570|144355251|OTHER||Mean Difference (Net)|0.16|STANDARD_ERROR_OF_MEAN|0.06|=|0.01|TWO_SIDED|95.0|0.04|0.28|||Mixed Models Analysis|||Extinction retention||.28|.04|=.01
72422295|NCT02801669|144355252|OTHER||Cox Proportional Hazard|0.339||||0.0003|TWO_SIDED|95.0|0.188|0.608|||Regression, Cox|The treatment groups were compared using a Cox proportional hazard model with the CHADS2 score (\<= 2 or \>= 3) as covariate.||This statistical analysis assesses the annual incidence of composite event of stroke and SEE between treatment groups.||0.608|0.188|0.0003
72422296|NCT02801669|144355253|OTHER||Cox Proportional Hazard|0.299|||||TWO_SIDED|95.0|0.157|0.57|||||The treatment groups were compared using a Cox proportional hazard model with the CHADS2 score (\<= 2 or \>= 3) as covariate.|This statistical analysis assesses the annual incidence of stroke between treatment groups.||0.570|0.157|
72330732|NCT01500252|144187675|SUPERIORITY_OR_OTHER_LEGACY|||||||0.35||95.0|||||t-test, 2 sided|||||||0.35
72330733|NCT01500252|144187676|SUPERIORITY_OR_OTHER_LEGACY|||||||0.31||95.0|||||Chi-squared|||||||0.31
72330734|NCT03115827|144187681|OTHER|||||||0.6|||||||t-test, 2 sided|||||||0.6
72330735|NCT05319600|144187682|SUPERIORITY|treatment group as predictor baseline-residualized week 12 scores in linear regression|Slope|129.2|STANDARD_ERROR_OF_MEAN|73.96|<|0.05|TWO_SIDED|95.0|-22.52|280.98|||Regression, Linear||Control coded as 0 and treatment as 1|||280.98|-22.52|<0.05
72330736|NCT00323960|144187683|SUPERIORITY|||||||0.0228||||||For multiple hypothesis testing, we used Bonferroni's correction (with n=3 posterior comparisons).|Chi-squared|To assess proportions we used the χ² test or Fisher's exact test||We calculated that a sample size of 40 patients would be needed in each study group (total 120 patients) to have 80% power for comparison of combination treatments (prednisone plus methotrexate or prednisone plus ciclosporin) with the reference treatment (prednisone alone).||||0.0228
72330737|NCT00323960|144187684|SUPERIORITY||Relative risk|2.45||||0.012|TWO_SIDED|95.0|1.2|5.0|||Log Rank||RR related to prednisone plus methotrexate arm (group 3) versus prednisone alone (group 1) and prednisone plus ciclosporin (group 2).|We used the Kaplan-Meier method to produce survival curves (groups 1 and 2 versus group 3) and compared them with the Log-Rank test. We judged a p value less than 0·05 significant. We reported in the table the incidence rates with 95% confidence intervals of the 3 groups.||5.0|1.2|0.012
72330738|NCT00323960|144187685|SUPERIORITY||Relative risk|1.95||||0.009|TWO_SIDED|95.0|1.2|3.15|||Log Rank||RR related to prednisone alone (group 1) versus prednisone plus ciclosporin (group 2) and prednisone plus methotrexate arm (group 3).|We used the Kaplan-Meier method to produce survival curves (group 1 versus groups 2 and 3) and compared them with the Log-Rank test. We judged a p value less than 0·05 significant. We reported in the table the incidence rates with 95% confidence intervals of the 3 groups.||3.15|1.2|0.009
72330739|NCT00323960|144187686|SUPERIORITY||Relative risk|1.65||||0.002|TWO_SIDED|95.0|1.24|2.14|||Log Rank||RR related to prednisone+methotrexate arm or prednisone+ciclosporin versus prednisone alone.|We used the Kaplan-Meier method to produce survival curves (groups 2 and 3 versus group 1) and compared them with the Log-Rank test. We judged a p value less than 0·05 significant. We reported in the table the incidence rates with 95% confidence intervals of the 3 groups.||2.14|1.24|0.002
72330740|NCT00323960|144187686|SUPERIORITY||Relative risk|1.65||||0.002|TWO_SIDED|95.0|1.24|2.14|||Log Rank||RR related to prednisone alone (group 1) versus prednisone plus ciclosporin (group 2) and prednisone plus methotrexate arm (group 3).|We used the Kaplan-Meier method to produce survival curves (groups 1 versus groups 2 and 3) and compared them with the Log-Rank test. We judged a p value less than 0·05 significant. We reported in the table the incidence rates with 95% confidence intervals of the 3 groups.||2.14|1.24|0.002
72330741|NCT00177294|144187717|SUPERIORITY_OR_OTHER|||||||0.14||95.0|||||Regression, Logistic|||We conducted Cox regreassion analyses of time to remission and logistic modeling for rates of remission. We tested group difference in Hamilton depession ratings over time via mixed-effects modeling.||||0.14
72330742|NCT00361231|144187735|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Kaplan-Meier|||||||<0.05
72330743|NCT00361231|144187736|SUPERIORITY_OR_OTHER|||||||0.05|TWO_SIDED||||||Kaplan-Meier|||||||0.05
72330744|NCT00744380|144187806|SUPERIORITY_OR_OTHER|||||||0.8|||||||Wilcoxon (Mann-Whitney)|||||||0.8
72330745|NCT00744380|144187807|SUPERIORITY_OR_OTHER|||||||0.25|||||||Wilcoxon (Mann-Whitney)|||For open label midazolam||||0.25
72330746|NCT00744380|144187807|SUPERIORITY_OR_OTHER|||||||0.048|||||||Wilcoxon (Mann-Whitney)|||For all midazolam||||0.048
72330747|NCT00744380|144187807|SUPERIORITY_OR_OTHER|||||||0.88|||||||Wilcoxon (Mann-Whitney)|||For fentanyl||||0.88
72330748|NCT00744380|144187808|SUPERIORITY_OR_OTHER|||||||0.75|||||||Chi-squared, Corrected|||For Riker scores||||0.75
72330749|NCT00744380|144187808|SUPERIORITY_OR_OTHER|||||||0.17|||||||Chi-squared|||For pain scores||||0.17
72330750|NCT00744380|144187809|SUPERIORITY_OR_OTHER||||||>|0.1|||||||Chi-squared, Corrected|||For hypotension||||>0.1
72330751|NCT00744380|144187809|SUPERIORITY_OR_OTHER||||||>|0.1|||||||Chi-squared, Corrected|||For bradycardia||||>0.1
72330752|NCT00744380|144187809|SUPERIORITY_OR_OTHER||||||>|0.1|||||||Fisher Exact|||For tachycardia||||>0.1
72330753|NCT00744380|144187809|SUPERIORITY_OR_OTHER|||||||0.07|||||||Fisher Exact|||For delirium, new onset||||0.07
72330754|NCT00744380|144187810|SUPERIORITY_OR_OTHER|||||||0.015|||||||Wilcoxon (Mann-Whitney)|||Median number of experiences remembered||||0.015
72330755|NCT00744380|144187811|SUPERIORITY_OR_OTHER|||||||0.5|||||||Wilcoxon (Mann-Whitney)|||||||0.5
72330756|NCT00744380|144187812|SUPERIORITY_OR_OTHER|||||||0.029|||||||t-test, 2 sided|||||||0.029
72330757|NCT00744380|144187813|SUPERIORITY_OR_OTHER||||||>|0.1|||||||t-test, 2 sided|||For anxiety||||>0.1
72330758|NCT00744380|144187813|SUPERIORITY_OR_OTHER||||||>|0.1|||||||t-test, 2 sided|||For depression||||>0.1
72330759|NCT00810771|144187815|SUPERIORITY_OR_OTHER|||||||0.873|TWO_SIDED||||||Chi-squared|||||||0.873
72330760|NCT00810771|144187816|SUPERIORITY_OR_OTHER|||||||0.671|TWO_SIDED||||||Chi-squared|||||||0.671
72330761|NCT00810771|144187817|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED||||||Chi-squared|||||||0.002
72330762|NCT00810771|144187818|SUPERIORITY_OR_OTHER|||||||0.186|TWO_SIDED||||||Chi-squared|||||||0.186
72330763|NCT00810771|144187819|SUPERIORITY_OR_OTHER|||||||0.576|TWO_SIDED||||||Chi-squared|||||||0.576
72330764|NCT00810771|144187820|SUPERIORITY_OR_OTHER|||||||0.35|TWO_SIDED||||||Chi-squared|||||||0.35
72368927|NCT04730271|144247549|SUPERIORITY|||||||0.0074|||||||t-test, 2 sided|||T-Test P-value tests the significance of the difference between ROBOTIC and MANUAL for pain at rest at 12 weeks||||0.0074
72368928|NCT04730271|144247549|SUPERIORITY|||||||0.0663|||||||t-test, 2 sided|||T-Test P-value tests the significance of the difference between ROBOTIC and MANUAL for Pain at rest at 1 year||||0.0663
72368929|NCT04730271|144247549|SUPERIORITY|||||||0.7096|||||||t-test, 2 sided|||T-test P-value for difference in change from baseline between ROBOTIC and MANUAL for Pain with Activity at 1 year||||0.7096
72368930|NCT04730271|144247549|SUPERIORITY|||||||0.5321|||||||t-test, 2 sided|||T-test P-value for difference in change from baseline between ROBOTIC and MANUAL for pain with activity at 12 weeks||||0.5321
72368931|NCT04730271|144247549|SUPERIORITY|||||||0.0709|||||||t-test, 2 sided|||T-Test P-value tests the significance of the difference between ROBOTIC and MANUAL for Pain with activity at 12 weeks||||0.0709
72368932|NCT04730271|144247549|SUPERIORITY|||||||0.1274|||||||t-test, 2 sided|||T-Test P-value tests the significance of the difference between ROBOTIC and MANUAL for Pain with activity at 1 year||||0.1274
72368933|NCT04730271|144247550|SUPERIORITY|||||||0.6745|||||||t-test, 2 sided|||Comparison between the accuracy achieved in the first 10 cases compared to the subsequent cases||||0.6745
72368934|NCT03599089|144247557|SUPERIORITY|||||||0.005|||||||ANOVA|||||||0.005
72368935|NCT03599089|144247558|SUPERIORITY|||||||0.0245|||||||Regression, Logistic|||||||0.0245
72368936|NCT03599089|144247559|SUPERIORITY|||||||0.0019|||||||ANOVA|||||||0.0019
72368937|NCT01354314|144247642|SUPERIORITY|||||||0.893|||||||Regression, Linear|||||||0.893
72368938|NCT01354314|144247642|SUPERIORITY|||||||0.594|||||||Regression, Linear|||||||0.594
72368939|NCT01354314|144247642|SUPERIORITY|||||||0.712|||||||Regression, Linear|||||||0.712
72368940|NCT01354314|144247643|SUPERIORITY|||||||0.673|||||||Regression, Linear|||||||0.673
72368941|NCT01354314|144247643|SUPERIORITY|||||||0.153|||||||Regression, Linear|||||||0.153
72368942|NCT01354314|144247643|SUPERIORITY|||||||0.282|||||||Regression, Linear|||||||0.282
72368943|NCT01354314|144247644|SUPERIORITY|||||||0.327|||||||Regression, Linear|||||||0.327
72368944|NCT01354314|144247644|SUPERIORITY|||||||0.178|||||||Regression, Linear|||||||0.178
72368945|NCT01354314|144247644|SUPERIORITY|||||||0.48|||||||Regression, Linear|||||||0.480
72368946|NCT01354314|144247645|SUPERIORITY|||||||0.267|||||||Regression, Linear|||||||0.267
72368947|NCT01354314|144247645|SUPERIORITY|||||||0.368|||||||Regression, Linear|||||||0.368
72368948|NCT01354314|144247645|SUPERIORITY|||||||0.672|||||||Regression, Linear|||||||0.672
72368949|NCT01931566|144247720|OTHER|||||||0.023|||||||Regression, Cox|||||||0.023
72368950|NCT01931566|144247721|SUPERIORITY|||||||0.307|||||||Regression, Cox|||||||0.307
72368951|NCT04625101|144247759|SUPERIORITY|||||||0.4326|||||||ANCOVA|||||||0.4326
72368952|NCT02817464|144247800|OTHER||Geometric Mean Ratio|1.84|||||TWO_SIDED|90.0|1.44|2.36||||||||2.36|1.44|
72368953|NCT02817464|144247801|OTHER||Geometric Mean Ratio|0.66|||||TWO_SIDED|90.0|0.33|1.33||||||||1.33|0.33|
72368954|NCT02817464|144247803|OTHER||Geometric Mean Ratio|1.67|||||TWO_SIDED|90.0|1.33|2.09||||||||2.09|1.33|
72368955|NCT02817464|144247804|OTHER||Geometric Mean Ratio|1.61|||||TWO_SIDED|90.0|1.3|2.01||||||||2.01|1.30|
72368956|NCT02817464|144247805|OTHER||Geometric Mean Ratio|1.21|||||TWO_SIDED|90.0|1.04|1.4||||||||1.40|1.04|
72368957|NCT02817464|144247806|OTHER||Geometric Mean Ratio|0.51|||||TWO_SIDED|90.0|0.23|1.13||||||||1.13|0.23|
72368958|NCT02817464|144247808|OTHER|||||||0.0073|||||||Log Rank|||||||0.0073
72368959|NCT02453711|144247819|OTHER||Treatment difference (%-points)|-3.7|STANDARD_ERROR_OF_MEAN|1.13|=|0.0055|TWO_SIDED|95.0|-6.55|-0.85|||ANCOVA||Semaglutide 0.05 mg - placebo pool|J2R-MI: Analysis of in-trial data with missing observations imputed from the pooled placebo arms based on a jump to reference multiple (x1000) imputation (J2R-MI) approach. Week 52 responses were analysed using an analysis of covariance model with treatment, region and sex as factors and baseline body weight as covariate. Dunnett's method was used to adjust for multiple comparisons.||-0.85|-6.55|=0.0055
72422297|NCT02801669|144355253|OTHER||Cox Proportional Hazard|0.503|||||TWO_SIDED|95.0|0.126|2.011|||||The treatment groups were compared using a Cox proportional hazard model with the CHADS2 score (\<= 2 or \>= 3) as covariate.|This statistical analysis assesses the annual incidence of SEE between treatment groups.||2.011|0.126|
72422298|NCT02801669|144355253|OTHER||Cox Proportional Hazard|0.306|||||TWO_SIDED|95.0|0.16|0.585|||||The treatment groups were compared using a Cox proportional hazard model with the CHADS2 score (\<= 2 or \>= 3) as covariate.|This statistical analysis assesses the annual incidence of ischemic stroke between treatment groups.||0.585|0.160|
72422299|NCT02801669|144355253|OTHER||Cox Proportional Hazard|0.347|||||TWO_SIDED|95.0|0.193|0.624|||||The treatment groups were compared using a Cox proportional hazard model with the CHADS2 score (\<= 2 or \>= 3) as covariate.|This statistical analysis assesses the annual incidence of ischemic stroke/SEE between treatment groups.||0.624|0.193|
72422300|NCT01966003|144355263|NON_INFERIORITY_OR_EQUIVALENCE|Clinical equivalence of the primary endpoint was demonstrated by comparing the 2-sided 90% CI of the risk ratio in objective response rate between ABP 215 and bevacizumab with an equivalence margin of (0.67, 1.5).|Risk Ratio (RR)|0.93|||||TWO_SIDED|90.0|0.8|1.09||||||The risk ratio (ABP 215/Bevacizumab) and 90% confidence interval (CI) were estimated using a generalized linear model adjusted for the stratification factors (region, sex, and ECOG performance status).||1.09|0.80|
72422301|NCT01966003|144355263|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-2.9|||||TWO_SIDED|90.0|-9.26|3.45||||||Risk difference (ABP 215 - Bevacizumab) and 90% CI were estimated using a generalized linear model adjusted for the randomization stratification factors geographic region, ECOG performance status, and sex.||3.45|-9.26|
72422302|NCT01966003|144355265|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.03|||||TWO_SIDED|90.0|0.83|1.29||||||The hazard ratio for ABP 215 relative to bevacizumab was based on a stratified Cox proportional hazards model. Stratification factors are geographic region, ECOG performance status, and sex.||1.29|0.83|
72422303|NCT01966003|144355268|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.1|||||TWO_SIDED|90.0|0.75|1.61||||||Hazard ratio for ABP 215 relative to bevacizumab, based on a stratified Cox proportional hazards model. Stratification factors are geographic region, ECOG performance status, and sex.||1.61|0.75|
72422304|NCT02696564|144355269|SUPERIORITY|We will estimate a 95% confidence interval for the losartan vs placebo mean difference, using the regression estimate and the t-distribution; we will reject the null that losartan is equivalent to placebo if the 95% interval excludes 0.0.||||||0.133|||||||Mixed Models Analysis|P-value based on generalized linear mixed models with covariates for site, baseline value, and for treatment group.||||||0.133
72422305|NCT02696564|144355270|SUPERIORITY|Statistical differences were inferred if the 95% confidence intervals (CI) did not include zero.||||||0.762||||||P-value based on generalized linear mixed models with covariates for site, baseline value, and for treatment group.|Mixed Models Analysis|||||||0.762
72422306|NCT02696564|144355271|SUPERIORITY|Statistical differences were inferred if the 95% confidence intervals (CI) did not include zero.||||||0.834||||||P-value based on generalized linear mixed models with covariates for site, baseline value, and for treatment group.|Mixed Models Analysis|||||||0.834
72422307|NCT02696564|144355272|SUPERIORITY|Statistical differences were inferred if the 95% confidence intervals (CI) did not include zero.||||||0.783||||||P-value based on generalized linear mixed models with covariates for site, baseline value, and for treatment group.|Mixed Models Analysis|||||||0.783
72422308|NCT02696564|144355273|SUPERIORITY|Statistical differences were inferred if the 95% confidence intervals (CI) did not include zero.||||||0.053||||||P-value based on generalized linear mixed models with covariates for site, baseline value, and for treatment group.|Mixed Models Analysis|||||||0.053
72422309|NCT02696564|144355274|SUPERIORITY|Statistical differences were inferred if the 95% confidence intervals (CI) did not include zero.||||||0.016||||||P-value based on generalized linear mixed models with covariates for site, baseline value, and for treatment group.|Mixed Models Analysis|||||||0.016
72422310|NCT02696564|144355275|SUPERIORITY|Statistical differences were inferred if the 95% confidence intervals (CI) did not include zero.||||||0.065||||||P-value based on generalized linear mixed models with covariates for site, baseline value, and for treatment group.|Mixed Models Analysis|||||||0.065
72422311|NCT02696564|144355276|SUPERIORITY|Statistical differences were inferred if the 95% confidence intervals (CI) did not include zero.||||||0.293||||||P-value based on generalized linear mixed models with covariates for site, baseline value, and for treatment group.|Mixed Models Analysis|||||||0.293
72422312|NCT02696564|144355277|SUPERIORITY|Statistical differences were inferred if the 95% confidence intervals (CI) did not include zero.||||||0.356||||||P-value based on generalized linear mixed models with covariates for site, baseline value, and for treatment group.|Mixed Models Analysis|||||||0.356
72368960|NCT02453711|144247819|OTHER||Treatment difference (%-points)|-6.32|STANDARD_ERROR_OF_MEAN|1.12|<|0.0001|TWO_SIDED|95.0|-9.16|-3.49|||ANCOVA||Semaglutide 0.1 mg - placebo pool|J2R-MI: Analysis of in-trial data with missing observations imputed from the pooled placebo arms based on a jump to reference multiple (x1000) imputation (J2R-MI) approach. Week 52 responses were analysed using an analysis of covariance model with treatment, region and sex as factors and baseline body weight as covariate. Dunnett's method was used to adjust for multiple comparisons.||-3.49|-9.16|<0.0001
72368961|NCT02453711|144247819|OTHER||Treatment difference (%-points)|-9.31|STANDARD_ERROR_OF_MEAN|1.12|<|0.0001|TWO_SIDED|95.0|-12.15|-6.46|||ANCOVA||Semaglutide 0.2 mg - placebo pool|J2R-MI: Analysis of in-trial data with missing observations imputed from the pooled placebo arms based on a jump to reference multiple (x1000) imputation (J2R-MI) approach. Week 52 responses were analysed using an analysis of covariance model with treatment, region and sex as factors and baseline body weight as covariate. Dunnett's method was used to adjust for multiple comparisons.||-6.46|-12.15|<0.0001
72368962|NCT02453711|144247819|OTHER||Treatment difference (%-points)|-8.88|STANDARD_ERROR_OF_MEAN|1.12|<|0.0001|TWO_SIDED|95.0|-11.72|-6.03|||ANCOVA||Semaglutide 0.3 mg - placebo pool|J2R-MI: Analysis of in-trial data with missing observations imputed from the pooled placebo arms based on a jump to reference multiple (x1000) imputation (J2R-MI) approach. Week 52 responses were analysed using an analysis of covariance model with treatment, region and sex as factors and baseline body weight as covariate. Dunnett's method was used to adjust for multiple comparisons.||-6.03|-11.72|<0.0001
72369547|NCT00233064|144249499|SUPERIORITY_OR_OTHER||Overall percentage of immune reactivity|0.3||||||95.0|0.0|1.5|||||The number and percentage of subjects with immune reactivity at Study Day 240-300 were constructed using the Clopper-Pearson Method.|The subject number of 200 per treatment group was derived to demonstrate a percentage of immune reactivity in either the liquid or lyophilized formulations of palivizumab of \<2-3% based on 95% confidence intervals \[(0%; 0.00, 1.83), (0.5%; 0.01, 2.75), (1%; 0.12, 3.57)\].||1.5|0.0|
72369548|NCT03508908|144249504|OTHER||US dollars per DALY averted|3098.0|||||TWO_SIDED||||||||Cost (in US dollars) per DALY averted (Intervention referenced to Observation)|Cost (in US dollars) per DALY averted (Intervention referenced to Observation)||||
72369549|NCT01120964|144249523|OTHER|Analyses presented herein are for re-intubation time included.|Mean Difference (Final Values)|32.0||||0.0222|TWO_SIDED|95.0|-9.5|73.4||The threshold for statistical significance was p\<0.05|Wilcoxon (Mann-Whitney)|||"Total duration of postoperative invasive mechanical ventilation was analyzed by treatment group using summary statistics, and was compared between citrulline and placebo groups using an ANOVA.~Kaplan-Meier analyses were performed for: 1) zero durations censored, 2) zero durations uncensored, 3) patients with zero duration excluded. The same analyses were performed with re-intubation time removed."||73.4|-9.5|0.0222
72369550|NCT01120964|144249524|OTHER||Mean Difference (Final Values)|32.0||||0.0222|TWO_SIDED|95.0|-9.5|73.4||Re-intubation time included. Threshold for significance was p\<0.05|t-test, 2 sided|||Analyses presented herein are for re-intubation time included.||73.4|-9.5|0.0222
72369551|NCT01120964|144249525|OTHER||Mean Difference (Final Values)|50.7||||0.0418|TWO_SIDED|95.0|5.4|96.0||The threshold for significance was P\<0.05|Wilcoxon (Mann-Whitney)|||||96.0|5.4|0.0418
72369552|NCT01120964|144249526|OTHER||Mean Difference (Final Values)|12.7||||0.0727|TWO_SIDED|95.0|-2.6|28.1||The threshold for significance was p\<0.05|Wilcoxon (Mann-Whitney)|||||28.1|-2.6|0.0727
72369553|NCT01120964|144249527|OTHER||Mean Difference (Final Values)|559.8||||0.1271|TWO_SIDED|95.0|-193.5|1313.2|||Wilcoxon (Mann-Whitney)|||||1313.2|-193.5|0.1271
72369554|NCT01120964|144249528|OTHER||Mean Difference (Final Values)|3.5||||0.972|TWO_SIDED|95.0|-7.0|14.1|||Wilcoxon (Mann-Whitney)|||||14.1|-7.0|0.9720
72369555|NCT01120964|144249529|OTHER||Mean Difference (Final Values)|5.2||||0.8884|TWO_SIDED|95.0|-7.7|18.0|||Wilcoxon (Mann-Whitney)|||||18.0|-7.7|0.8884
72369556|NCT01120964|144249530|OTHER|Total number of postoperative hours spent in PICU|Mean Difference (Final Values)|69.14||||0.1891|TWO_SIDED|95.0|-49.39|187.67||The threshold for significance was p\<0.05|Wilcoxon (Mann-Whitney)|||||187.67|-49.39|0.1891
72330765|NCT02285023|144187821|NON_INFERIORITY_OR_EQUIVALENCE|Principal component analysis with varimax rotation was employed. An eigenvalue ≥ 1 was chosen as the criterion to retain domains. Each item was classified into the domain when loading with a domain loading ≥ 0.5.|||||<|0.01||||||An eigenvalue ≥ 1 was chosen as the criterion to retain domains. Each item was classified into the domain when loading with a domain loading ≥ 0.5|exploratory factor analysis|An eigenvalue ≥ 1 was chosen as the criterion to retain domains. Each item was classified into the domain when loading with a domain loading ≥ 0.5||Exploratory factor analysis||||<0.01
72422313|NCT02696564|144355278|SUPERIORITY|Statistical differences were inferred if the 95% confidence intervals (CI) did not include zero.||||||0.009||||||P-value based on generalized linear mixed models with covariates for site, baseline value, and for treatment group.|Mixed Models Analysis|||||||0.009
72422314|NCT02696564|144355279|SUPERIORITY||Relative rate (losartan to placebo)|0.8||||0.892|TWO_SIDED|95.0|0.03|18.77|||Negative binomial model|||P-value for rate of mild exacerbations between treatment groups (measured in events per 100 person-years).||18.77|0.03|0.892
72422315|NCT02696564|144355279|SUPERIORITY||Relative rate (losartan to placebo)|0.91||||0.946|TWO_SIDED|95.0|0.05|14.97|||Negative binomial model|||P-value for rate of moderate exacerbations between treatment groups (measured in events per 100 person-years).||14.97|0.05|0.946
72422316|NCT02696564|144355279|SUPERIORITY||Relative rate (losartan to placebo)|0.36||||0.487|TWO_SIDED|95.0|0.02|6.51|||Negative binomial model|||P-value for rate of severe exacerbations between treatment groups (measured in events per 100 person-years).||6.51|0.02|0.487
72422317|NCT02287584|144355293|SUPERIORITY||Mean Difference (Final Values)|-5.6|STANDARD_ERROR_OF_MEAN|2.04||0.007|TWO_SIDED|95.0|-9.6|-1.6||adjusted p value, Hochberg procedure|Mixed Models Analysis|||Using Mixed Model for Repeated Measures||-1.6|-9.6|0.007
72330766|NCT02285023|144187822|SUPERIORITY_OR_OTHER||Cronbach's alpha|0.94|||<|0.05|TWO_SIDED||||||Crohbach's alpha|||||||<0.05
72422318|NCT02287584|144355293|SUPERIORITY||Mean Difference (Final Values)|-10.4|STANDARD_ERROR_OF_MEAN|2.03|<|0.001|TWO_SIDED|95.0|-14.4|-6.4||adjusted p-value, Hochberg procedure|Mixed Models Analysis|||||-6.4|-14.4|<0.001
72422319|NCT02884414|144355306|OTHER|Paired Student's t-test.||||||0.44|||||||t-test, 2 sided|||||||0.44
72330767|NCT03989349|144187836|OTHER||Strata-adjusted percentage difference|12.2||||0.0006|TWO_SIDED|97.5|4.6|19.8||Strata-adjusted p-values were calculated from Cochran-Mantel-Haenszel test adjusting randomized stratification variables (IGA severity \[3=moderate, 4=severe\] and PP NRS \[\>=7, \<7\]).|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control the overall type I error. Testing was performed sequentially in order the outcome measures were reported and continued when the test for the preceding outcome measure was statistically significant at two-sided 2.5% significance level.||19.8|4.6|0.0006
72330768|NCT03989349|144187837|OTHER||Strata-adjusted percentage difference|14.9||||0.0008|TWO_SIDED|97.5|5.6|24.3||Strata-adjusted p-values were calculated from Cochran-Mantel-Haenszel test adjusting randomized stratification variables (IGA severity \[3=moderate, 4=severe\]).|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control the overall type I error. Testing was performed sequentially in order the outcome measures were reported and continued when the test for the preceding outcome measure was statistically significant at two-sided 2.5% significance level.||24.3|5.6|0.0008
72422320|NCT02798211|144355313|SUPERIORITY||Odds Ratio (OR)|3.51||||0.0011|TWO_SIDED|95.0|1.65|7.45|||Regression, Logistic|Statistical analysis (logistic regression) of ACR20 response in treatment period 1 (non-responder imputation)||secukinumab 300mg s.c. injection, 16 weeks||7.45|1.65|0.0011
72330769|NCT03989349|144187838|OTHER||Strata-adjusted percentage difference|12.5||||0.0006|TWO_SIDED|97.5|4.6|20.3||Strata-adjusted p-values were calculated from Cochran-Mantel-Haenszel test adjusting randomized stratification variables (IGA severity \[3=moderate, 4=severe\] and PP NRS \[\>=7, \<7\]).|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control the overall type I error. Testing was performed sequentially in order the outcome measures were reported and continued when the test for the preceding outcome measure was statistically significant at two-sided 2.5% significance level.||20.3|4.6|0.0006
72422321|NCT02798211|144355313|SUPERIORITY||Odds Ratio (OR)|1.92||||0.0961|TWO_SIDED|95.0|0.89|4.15|||Regression, Logistic|Statistical analysis (logistic regression) of ACR20 response in treatment period 1 (non-responder imputation)||secukinumab 150 mg s.c. injection, 16 weeks||4.15|0.89|0.0961
72422322|NCT02798211|144355314|SUPERIORITY||Odds Ratio (OR)|0.6||||0.333|TWO_SIDED|95.0|0.22|1.68|||Regression, Logistic|Statistical analysis (logistic regression) of presence of dactylitis by visit in treatment period 1 (non-responder imputation)||secukinumab 300 mg s.c. injection, 16 weeks||1.68|0.22|0.3330
72422323|NCT02798211|144355314|SUPERIORITY||Odds Ratio (OR)|0.4||||0.0841|TWO_SIDED|95.0|0.14|1.13|||Regression, Logistic|Statistical analysis (logistic regression) of presence of dactylitis in treatment period 1 (non-responder imputation)||secukinumab 150 mg s.c. injection, 16 weeks||1.13|0.14|0.0841
72330770|NCT03989349|144187839|OTHER||Strata-adjusted percentage difference|16.3||||0.0004|TWO_SIDED|97.5|6.6|26.0||Strata-adjusted p-values were calculated from Cochran-Mantel-Haenszel test adjusting randomized stratification variables (IGA severity \[3=moderate, 4=severe\]).|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control the overall type I error. Testing was performed sequentially in order the outcome measures were reported and continued when the test for the preceding outcome measure was statistically significant at two-sided 2.5% significance level.||26.0|6.6|0.0004
72369557|NCT01120964|144249531|OTHER||Mean Difference (Final Values)|30.2||||0.0479|TWO_SIDED|95.0|-10.8|71.1||Duration including re-intubation time. Threshold for significance was p\<0.05|Wilcoxon (Mann-Whitney)|||||71.1|-10.8|0.0479
72369558|NCT01120964|144249532|OTHER||Mean Difference (Final Values)|3.7||||0.2637|TWO_SIDED|95.0|-2.2|9.7|||Wilcoxon (Mann-Whitney)|||||9.7|-2.2|0.2637
72369559|NCT01120964|144249534|OTHER||Mean Difference (Final Values)|7.5||||0.6431|TWO_SIDED|95.0|-25.9|41.0|||t-test, 2 sided|||||41.0|-25.9|0.6431
72369560|NCT01120964|144249535|OTHER||Mean Difference (Final Values)|39.5||||0.6408|TWO_SIDED|95.0|-134.2|213.1|||ANOVA|||||213.1|-134.2|0.6408
72369561|NCT00826202|144249547|SUPERIORITY_OR_OTHER|||||||0.07|TWO_SIDED||||||Mixed Models Analysis|cohen's d= 0.67||||||0.07
72369562|NCT00826202|144249548|SUPERIORITY_OR_OTHER|||||||0.056|TWO_SIDED||||||t-test, 2 sided|cohen's d=0.84||||||.056
72369563|NCT00826202|144249549|SUPERIORITY_OR_OTHER|||||||0.03|TWO_SIDED||||||Mixed Models Analysis|Cohen's d=0.68||||||0.03
72369564|NCT00826202|144249550|SUPERIORITY_OR_OTHER|||||||0.12|TWO_SIDED||||||Mixed Models Analysis|cohen's d=0.93||||||0.12
72369565|NCT00829504|144249561|NON_INFERIORITY_OR_EQUIVALENCE|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|100.16||||||90.0|95.5|105.04|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||105.04|95.5|
72369566|NCT00829504|144249562|NON_INFERIORITY_OR_EQUIVALENCE|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|101.76||||||90.0|95.45|108.49|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||108.49|95.45|
72422324|NCT02798211|144355315|SUPERIORITY||Odds Ratio (OR)|0.52||||0.1618|TWO_SIDED|95.0|0.21|1.3|||Regression, Logistic|Statistical analysis (logistic regression) of presence of enthesitis (SPARCC) in treatment period 1 (non-responder imputation)||secukinumab 300mg s.c. injection, 16 weeks||1.30|0.21|0.1618
72422325|NCT02798211|144355315|SUPERIORITY||Odds Ratio (OR)|0.46||||0.0898|TWO_SIDED|95.0|0.19|1.13|||Regression, Logistic|Statistical analysis (logistic regression) of presence of enthesitis (SPARCC) in treatment period 1 (non-responder imputation)||secukinumab 150mg s.c. injection, 16 weeks||1.13|0.19|0.0898
72422326|NCT02798211|144355316|SUPERIORITY||Odds Ratio (OR)|0.27||||0.0125|TWO_SIDED|95.0|0.09|0.75|||Regression, Logistic|Statistical analysis (logistic regression) of presence of enthesitis (LEI) in treatment period 1 (non-responder imputation)||secukinumab 300mg s.c. injection, 16 weeks||0.75|0.09|0.0125
72330771|NCT03989349|144187840|OTHER||Strata-adjusted percentage difference|23.2|||<|0.0001|TWO_SIDED|97.5|16.1|30.3||Strata-adjusted p-values were calculated from Cochran-Mantel-Haenszel test adjusting randomized stratification variables (IGA severity \[3=moderate, 4=severe\] and PP NRS \[\>=7, \<7\]).|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control the overall type I error. Testing was performed sequentially in order the outcome measures were reported and continued when the test for the preceding outcome measure was statistically significant at two-sided 2.5% significance level. Participants with missing data were considered non-responders.||30.3|16.1|<0.0001
72330772|NCT03989349|144187840|OTHER||Strata-adjusted percentage difference|27.8|||<|0.0001|TWO_SIDED|97.5|21.2|34.5||Strata-adjusted p-values were calculated from Cochran-Mantel-Haenszel test adjusting randomized stratification variables (IGA severity \[3=moderate, 4=severe\] and PP NRS \[\>=7, \<7\]).|Cochran-Mantel-Haenszel||The estimates are from 50 complete datasets by MI-MAR assumption.|Nemolizumab 30 mg versus Placebo using multiple imputation (MI) with missing at random (MAR) assumption.||34.5|21.2|<0.0001
72330773|NCT03989349|144187841|OTHER||Strata-adjusted percentage difference|27.1|||<|0.0001|TWO_SIDED|97.5|17.5|36.6||Strata-adjusted p-values were calculated from Cochran-Mantel-Haenszel test adjusting randomized stratification variables (IGA severity \[3=moderate, 4=severe\].|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control the overall type I error. Testing was performed sequentially in order the outcome measures were reported and continued when the test for the preceding outcome measure was statistically significant at two-sided 2.5% significance level. Participants with missing data were considered non-responders.||36.6|17.5|<0.0001
72330774|NCT03989349|144187841|OTHER||Strata-adjusted percentage difference|33.4|||<|0.0001|TWO_SIDED|97.5|24.5|42.3||Strata-adjusted p-values were calculated from Cochran-Mantel-Haenszel test adjusting randomized stratification variables (IGA severity \[3=moderate, 4=severe\].|Cochran-Mantel-Haenszel||The estimates are from 50 complete datasets by MI-MAR assumption.|Nemolizumab 30 mg versus Placebo using MI-MAR assumption.||42.3|24.5|<0.0001
72330775|NCT03989349|144187842|OTHER||Strata-adjusted percentage difference|17.1|||<|0.0001|TWO_SIDED|97.5|10.9|23.3||Strata-adjusted p-values were calculated from Cochran-Mantel-Haenszel test adjusting randomized stratification variables (IGA severity \[3=moderate, 4=severe\] and PP NRS \[\>=7, \<7\]).|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control the overall type I error. Testing was performed sequentially in order the outcome measures were reported and continued when the test for the preceding outcome measure was statistically significant at two-sided 2.5% significance level.||23.3|10.9|<0.0001
72330776|NCT03989349|144187843|OTHER||Strata-adjusted percentage difference|18.4|||<|0.0001|TWO_SIDED|97.5|11.0|25.8||Strata-adjusted p-values were calculated from Cochran-Mantel-Haenszel test adjusting randomized stratification variables (IGA severity \[3=moderate, 4=severe\]).|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control the overall type I error. Testing was performed sequentially in order the outcome measures were reported and continued when the test for the preceding outcome measure was statistically significant at two-sided 2.5% significance level.||25.8|11.0|<0.0001
72422327|NCT02798211|144355316|SUPERIORITY||Odds Ratio (OR)|0.25||||0.0086|TWO_SIDED|95.0|0.09|0.7|||Regression, Logistic|Statistical analysis (logistic regression) of presence of enthesitis (SPARCC) in treatment period 1 (non-responder imputation)||secukinumab 150mg s.c. injection, 16 weeks||0.70|0.09|0.0086
72422328|NCT02798211|144355317|SUPERIORITY||Odds Ratio (OR)|0.35||||0.0338|TWO_SIDED|95.0|0.13|0.92|||Regression, Logistic|Statistical analysis (logistic regression) of presence of enthesitis (SPARCC and LEI) in treatment period 1 (non-responder imputation)||secukinumab 300mg s.c. injection, 16 weeks||0.92|0.13|0.0338
72330777|NCT03989349|144187844|OTHER||Strata-adjusted percentage difference|17.5|||<|0.0001|TWO_SIDED|97.5|10.8|24.3||Strata-adjusted p-values were calculated from Cochran-Mantel-Haenszel test adjusting randomized stratification variables (IGA severity \[3=moderate, 4=severe\] and PP NRS \[\>=7, \<7\]).|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control the overall type I error. Testing was performed sequentially in order the outcome measures were reported and continued when the test for the preceding outcome measure was statistically significant at two-sided 2.5% significance level.||24.3|10.8|< 0.0001
72330778|NCT03989349|144187845|OTHER||Strata-adjusted percentage difference|21.9|||<|0.0001|TWO_SIDED|97.5|12.5|31.4||Strata-adjusted p-values were calculated from Cochran-Mantel-Haenszel test adjusting randomized stratification variables (IGA severity \[3=moderate, 4=severe\]).|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control the overall type I error. Testing was performed sequentially in order the outcome measures were reported and continued when the test for the preceding outcome measure was statistically significant at two-sided 2.5% significance level.||31.4|12.5|<0.0001
72330779|NCT03989349|144187846|OTHER||Strata-adjusted percentage difference|20.9|||<|0.0001|TWO_SIDED|97.5|15.6|26.1||Strata-adjusted p-values were calculated from Cochran-Mantel-Haenszel test adjusting the randomized stratification variables (IGA severity and PP NRS).|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control the overall type I error. Testing was performed sequentially in order the outcome measures were reported and continued when the test for the preceding outcome measure was statistically significant at two-sided 2.5% significance level.||26.1|15.6|< 0.0001
72330780|NCT03989349|144187847|OTHER||Strata-adjusted percentage difference|22.5|||<|0.0001|TWO_SIDED|97.5|15.0|29.9||Strata-adjusted p-values were calculated from Cochran-Mantel-Haenszel test adjusting randomized stratification variables (IGA severity \[3=moderate, 4=severe\]).|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control the overall type I error. Testing was performed sequentially in order the outcome measures were reported and continued when the test for the preceding outcome measure was statistically significant at two-sided 2.5% significance level.||29.9|15.0|<0.0001
72422329|NCT02798211|144355317|SUPERIORITY||Odds Ratio (OR)|0.36||||0.0359|TWO_SIDED|95.0|0.14|0.93|||Regression, Logistic|Statistical analysis (logistic regression) of presence of enthesitis (SPARCC and LEI) in treatment period 1 (non-responder imputation)||secukinumab 150mg s.c. injection, 16 weeks||0.93|0.14|0.0359
72330781|NCT03989349|144187848|OTHER||Strata-adjusted percentage difference|13.2|||<|0.0001|TWO_SIDED|97.5|9.0|17.4||Strata-adjusted p-values were calculated from Cochran-Mantel-Haenszel test adjusting randomized stratification variables (IGA severity \[3=moderate, 4=severe\] and PP NRS \[\>=7, \<7\]).|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control the overall type I error. Testing was performed sequentially in order the outcome measures were reported and continued when the test for the preceding outcome measure was statistically significant at two-sided 2.5% significance level.||17.4|9|< 0.0001
72330782|NCT03989349|144187849|OTHER||Strata-adjusted percentage difference|9.9||||0.0001|TWO_SIDED|97.5|5.5|14.3||Strata-adjusted p-values were calculated from Cochran-Mantel-Haenszel test adjusting randomized stratification variables (IGA severity \[3=moderate, 4=severe\]).|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control the overall type I error. Testing was performed sequentially in order the outcome measures were reported and continued when the test for the preceding outcome measure was statistically significant at two-sided 2.5% significance level.||14.3|5.5|0.0001
72330783|NCT03989349|144187850|OTHER||Strata-adjusted percentage difference|15.1|||<|0.0001|TWO_SIDED|97.5|11.0|19.2||Strata-adjusted p-values were calculated from Cochran-Mantel-Haenszel test adjusting randomized stratification variables (IGA severity \[3=moderate, 4=severe\] and PP NRS \[\>=7, \<7\]).|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control the overall type I error. Testing was performed sequentially in order the outcome measures were reported and continued when the test for the preceding outcome measure was statistically significant at two-sided 2.5% significance level||19.2|11|< 0.0001
72330784|NCT03989349|144187851|OTHER||Strata-adjusted percentage difference|16.3|||<|0.0001|TWO_SIDED|97.5|10.5|22.1||Strata-adjusted p-values were calculated from Cochran-Mantel-Haenszel test adjusting randomized stratification variables (IGA severity \[3=moderate, 4=severe\]).|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control the overall type I error. Testing was performed sequentially in order the outcome measures were reported and continued when the test for the preceding outcome measure was statistically significant at two-sided 2.5% significance level.||22.1|10.5|<0.0001
72330785|NCT03989349|144187852|OTHER||Strata-adjusted percentage difference|6.4|||<|0.0001|TWO_SIDED|97.5|3.8|9.1||Strata-adjusted p-values were calculated from Cochran-Mantel-Haenszel test adjusting randomized stratification variables (IGA severity \[3=moderate, 4=severe\] and PP NRS \[\>=7, \<7\]).|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control the overall type I error. Testing was performed sequentially in order the outcome measures were reported and continued when the test for the preceding outcome measure was statistically significant at two-sided 2.5% significance level.||9.1|3.8|<0.0001
72330786|NCT03989349|144187853|OTHER||Strata-adjusted percentage difference|8.0||||0.0004|TWO_SIDED|97.5|4.2|11.8||Strata-adjusted p-values were calculated from Cochran-Mantel-Haenszel test adjusting randomized stratification variables (IGA severity \[3=moderate, 4=severe\]).|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control the overall type I error. Testing was performed sequentially in order the outcome measures were reported and continued when the test for preceding outcome measure was statistically significant at two-sided 2.5% significance level.||11.8|4.2|0.0004
72330787|NCT01352221|144187854|SUPERIORITY||Mean Difference (Final Values)|2.18|STANDARD_ERROR_OF_MEAN|0.19|<|0.0001|ONE_SIDED|97.5|1.81||||ANCOVA|||ANCOVA for primary endpoint, Change in Hb concentration from Baseline to Week 12 in double-blind phase, FAS|||1.81|< 0.0001
72330788|NCT01352221|144187858|SUPERIORITY||Mean Difference (Final Values)|1.04|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001|ONE_SIDED|97.5|0.82||||ANCOVA|||ANCOVA analysis of the change in Hb concentration from Baseline to Week 4 of the double-blind phase - Full Analysis Set, multiple imputation|||0.82|< 0.0001
72330789|NCT01352221|144187859|SUPERIORITY||Mean Difference (Final Values)|1.73|STANDARD_ERROR_OF_MEAN|0.15|<|0.0001|ONE_SIDED|97.5|1.43|||ANCOVA analysis of Change in Hb concentration from Baseline to Week 8 of double-blind phase - FAS, multiple imputation|ANCOVA||||||1.43|< 0.0001
72330790|NCT01352221|144187870|SUPERIORITY||Mean Difference (Final Values)|2.18|STANDARD_ERROR_OF_MEAN|0.17|<|0.0001|ONE_SIDED|97.5|1.87||||ANCOVA|||ANCOVA sensitivity analysis of the Primary efficacy endpoint analysis on the PPAS|||1.87|< 0.0001
72330791|NCT01352221|144187871|SUPERIORITY||Mean Difference (Final Values)|2.15|STANDARD_ERROR_OF_MEAN|0.16|<|0.0001|ONE_SIDED|97.5|1.82||||ANCOVA|||ANCOVA sensitivity analysis of the Primary efficacy endpoint analysis on the FAS LOCF Change in Haemoglobin Concentration from Baseline to Week 12|||1.82|< 0.0001
72330792|NCT02016716|144187880|NON_INFERIORITY|Non-inferiority was claimed if the lower bound of the 1-sided 97.5% CI (or the lower bound of 2-sided 95% CI) of the mean difference between the 2 romosozumab groups was \> -2.0%.|Least Squares Mean Difference|-0.4|||||TWO_SIDED|95.0|-1.5|0.7|||||Based on ANCOVA model adjusting for treatment, and baseline lumbar spine BMD T-score.|The primary hypothesis was that the mean percent change from baseline in lumbar spine BMD at month 6 in participants receiving romosozumab 210 mg QM using the 90 mg/mL concentration would not be inferior to that in participants receiving romosozumab 210 mg QM using the 70 mg/mL concentration.||0.7|-1.5|
72330793|NCT02248649|144187885|SUPERIORITY|||||||0.2|||||||Mixed Models Analysis|covariates: baseline age and years of education||||||0.2
72330794|NCT02248649|144187886|SUPERIORITY|||||||0.04|||||||Mixed Models Analysis|||||||0.04
72330795|NCT02248649|144187887|SUPERIORITY|||||||0.02|||||||Mixed Models Analysis|||||||0.02
72330796|NCT00147017|144187927|SUPERIORITY|||||||0.05||||||calculated|Kruskal-Wallis|||||||0.05
72330797|NCT00147017|144187928|SUPERIORITY|||||||0.05||||||calculated|Kruskal-Wallis|||||||0.05
72330798|NCT00147017|144187929|SUPERIORITY|||||||0.05||||||calculated|Kruskal-Wallis|||||||0.05
72330799|NCT02374060|144187933|SUPERIORITY||Ratio of the proportion of BL|0.79|||<|0.0001|TWO_SIDED|99.87|0.65|0.96||Two sided type I error threshold was 0.00132 since recruitment was halted after the single pre-planned interim analysis|mixed effects model||Ratio of intravitreal over periocular|||.96|.65|<0.0001
72330800|NCT02374060|144187933|SUPERIORITY||Ratio of the proportion of BL|0.69|||<|0.0001|TWO_SIDED|99.87|0.56|0.86||the 2 sided type 1 error threshold was 0.000132 since recruitment was halted after the single preplanned interim analysis|mixed effects model||ratio of dexamethasone over periocular|||0.86|0.56|<0.0001
72330801|NCT02374060|144187933|NON_INFERIORITY|The non inferiority margin was 1.16|Ratio of the proportion of BL|0.88|||||TWO_SIDED|99.87|0.71|1.08|||||A mixed effects model was used to create the confidence interval for testing non-inferiority. The direction is the ratio of dexamethasone over intravitreal|||1.08|.71|
72422330|NCT02798211|144355318|SUPERIORITY||Odds Ratio, log|6.3||||0.0038|TWO_SIDED|95.0|1.81|21.88|||Regression, Logistic|Statistical analysis (logistic regression) of ACR50 response in treatment period 1 (non-responder imputation)||secukinumab 300mg s.c. injection, week 16||21.88|1.81|0.0038
72422331|NCT02798211|144355318|SUPERIORITY||Odds Ratio (OR)|4.77||||0.0149|TWO_SIDED|95.0|1.36|16.77|||Regression, Logistic|Statistical analysis (logistic regression) of ACR50 response by visit in treatment period 1 (non-responder imputation)||secukinumab 150 mg s.c. injection, week 16||16.77|1.36|0.0149
72422332|NCT02798211|144355319|SUPERIORITY||Odds Ratio, log|10.5||||0.0243|TWO_SIDED|95.0|1.36|81.3|||Regression, Logistic|Statistical analysis (logistic regression) of ACR70 response in treatment period 1 (non-responder imputation)||secukinumab 300mg s.c. injection, week 16||81.30|1.36|0.0243
72330802|NCT02374060|144187934|SUPERIORITY||Ratio of the proportion of BL|0.95||||0.35|TWO_SIDED|99.87|0.77|1.16||Two sided type I error threshold was 0.00132 since recruitment was halted after the single Two sided type I error threshold was 0.00132 since recruitment was halted after the single preplanned interim analysis|mixed effects model||Ratio of intravitreal over periocular|||1.16|0.77|0.35
72330803|NCT02374060|144187934|SUPERIORITY||Ratio of the proportion of BL|0.89||||0.07|TWO_SIDED|99.87|0.72|1.1||the 2 sided type 1 error threshold was 0.000132 since recruitment was halted after the single preplanned interim analysis|mixed effects model||ratio of dexamethasone over periocular|||1.10|0.72|0.07
72330804|NCT02374060|144187934|NON_INFERIORITY|The non inferiority margin was 1.16|Ratio of the proportion of BL|0.94|||||TWO_SIDED|99.87|0.77|1.16|||||A mixed effects model was used to create the confidence interval for testing non-inferiority. The direction is the ratio of dexamethasone over intravitreal|||1.16|0.77|
72330805|NCT02374060|144187935|SUPERIORITY||Difference in proportion|0.39|||<|0.0001|TWO_SIDED|95.0|0.24|0.53|||mixed effects model||Intravitreal - periocular|||0.53|0.24|<0.0001
72330806|NCT02374060|144187935|SUPERIORITY||Difference in proportion|0.44|||<|0.0001|TWO_SIDED|95.0|0.29|0.59|||mixed effects model||Dexamethasone - periocular|||0.59|0.29|<0.0001
72330807|NCT02374060|144187935|SUPERIORITY||Difference in proportion|0.05||||0.45|TWO_SIDED|95.0|-0.09|0.19|||mixed effects model||Dexamethasone - intravitreal|||0.19|-0.09|0.45
72330808|NCT02374060|144187936|SUPERIORITY||Difference in proportion|0.12||||0.1|TWO_SIDED|95.0|-0.03|0.27|||mixed effects model||Intravitreal - Periocular|||0.27|-0.03|0.10
72330809|NCT02374060|144187936|SUPERIORITY||Difference in proportion|0.12||||0.11|TWO_SIDED|95.0|-0.03|0.28|||mixed effects model||Dexamethasone - Periocular|||0.28|-0.03|0.11
72330810|NCT02374060|144187936|SUPERIORITY||Difference in proportion|0.002||||0.98|TWO_SIDED|95.0|-0.16|0.16|||mixed effects model||Dexamethasone - Intravitreal|||0.16|-0.16|0.98
72422333|NCT02798211|144355319|SUPERIORITY||Odds Ratio (OR)|5.42||||0.112|TWO_SIDED|95.0|0.67|43.64|||Regression, Logistic|Statistical analysis (logistic regression) of ACR70 response by visit in treatment period 1 (non-responder imputation)||secukinumab 150 mg s.c. injection, week 16||43.64|0.67|0.1120
72330811|NCT02374060|144187937|SUPERIORITY||Difference in proportion|0.27||||0.0005|TWO_SIDED|95.0|0.11|0.43|||mixed effects model||Intravitreal - periocular|||0.43|0.11|0.0005
72330812|NCT02374060|144187937|SUPERIORITY||Difference in proportion|0.4|||<|0.0001|TWO_SIDED|95.0|0.25|0.56|||mixed effects model||Dexamethasone - periocular|||0.56|0.25|<0.0001
72330813|NCT02374060|144187937|SUPERIORITY||Difference in proportion|0.13||||0.12|TWO_SIDED|95.0|-0.04|0.3|||mixed effects model||Dexamethasone - intravitreal|||0.30|-0.04|0.12
72330814|NCT02374060|144187938|SUPERIORITY||Difference in proportion|0.004||||0.96|TWO_SIDED|95.0|-0.16|0.17|||mixed effects model||Intravitreal - periocular|||0.17|-0.16|0.96
72330815|NCT02374060|144187938|SUPERIORITY||Difference in proportion|0.06||||0.51|TWO_SIDED|95.0|-0.11|0.23|||mixed effects model||Dexamethasone - periocular|||0.23|-0.11|0.51
72330816|NCT02374060|144187938|SUPERIORITY||Difference in proportion|0.05||||0.54|TWO_SIDED|95.0|-0.12|0.22|||mixed effects model||Dexamethasone - intravitreal|||0.22|-0.12|0.54
72422334|NCT02798211|144355320|SUPERIORITY||Odds Ratio, log|9.49|||<|0.0001|TWO_SIDED|95.0|3.73|24.16|||Regression, Logistic|Statistical analysis (logistic regression) of PASI75 response by visit in treatment period 1 (non-responder imputation)||secukinumab 300 mg s.c. injection, week 16||24.16|3.73|<0.0001
72330817|NCT02374060|144187939|SUPERIORITY||Difference in mean change from BL|5.32||||0.003|TWO_SIDED|95.0|1.82|8.82|||mixed effects model||Intravitreal - periocular|||8.82|1.82|0.003
72330818|NCT02374060|144187939|SUPERIORITY||Difference in mean change from BL|5.16||||0.004|TWO_SIDED|95.0|1.6|8.72|||mixed effects model||Dexamethasone - periocular|||8.72|1.60|0.004
72330819|NCT02374060|144187939|SUPERIORITY||Difference in mean change from BL|-0.16||||0.93|TWO_SIDED|95.0|-3.67|3.34|||mixed effects model||Dexamethasone - intravitreal|||3.34|-3.67|0.93
72330820|NCT02374060|144187940|SUPERIORITY||Difference in mean change from BL|5.53||||0.013|TWO_SIDED|95.0|1.14|9.92|||mixed effects model||Intravitreal - periocular|||9.92|1.14|0.013
72330821|NCT02374060|144187940|SUPERIORITY||Difference in mean change from BL|5.14||||0.019|TWO_SIDED|95.0|0.84|9.44|||mixed effects model||Dexamethasone - periocular|||9.44|0.84|0.019
72330822|NCT02374060|144187940|SUPERIORITY||Difference in mean change from BL|-0.4||||0.84|TWO_SIDED|95.0|-4.16|3.37|||mixed effects model||Dexamethasone-intravitreal|||3.37|-4.16|0.84
72330823|NCT02374060|144187944|SUPERIORITY||Hazard Ratio (HR)|0.33||||0.1|TWO_SIDED|95.0|0.09|1.24|||Regression, Cox||Intravitreal/Periocular|||1.24|0.09|0.10
72330824|NCT02374060|144187944|SUPERIORITY||Hazard Ratio (HR)|0.46||||0.2|TWO_SIDED|95.0|0.14|1.5|||Regression, Cox||Dexamethasone/Periocular|||1.50|0.14|0.20
72330825|NCT02374060|144187944|SUPERIORITY||Hazard Ratio (HR)|1.45||||0.62|TWO_SIDED|95.0|0.34|6.26|||Regression, Cox||Dexamethasone/Intravitreal|||6.26|0.34|0.62
72330826|NCT02374060|144187945|SUPERIORITY||Hazard Ratio (HR)|1.92||||0.11|TWO_SIDED|95.0|0.86|4.29|||Regression, Cox||Intravitreal/Periocular|||4.29|0.86|0.11
72330827|NCT02374060|144187945|SUPERIORITY||Hazard Ratio (HR)|2.85||||0.009|TWO_SIDED|95.0|1.3|6.28|||Regression, Cox||Dexamethasone/Intravitreal|||6.28|1.30|0.009
72330828|NCT02374060|144187945|SUPERIORITY||Hazard Ratio (HR)|1.43||||0.3|TWO_SIDED|95.0|0.72|2.81|||Regression, Cox||Dexamethasone/intravitreal|||2.81|0.72|0.30
72330829|NCT02374060|144187946|SUPERIORITY||Hazard Ratio (HR)|1.83||||0.09|TWO_SIDED|95.0|0.91|3.65|||Regression, Cox||Intravitreal/periocular|||3.65|0.91|0.09
72330830|NCT02374060|144187946|SUPERIORITY||Hazard Ratio (HR)|2.52||||0.007|TWO_SIDED|95.0|1.29|4.91|||Regression, Cox||Dexamethasone/periocular|||4.91|1.29|0.007
72330831|NCT02374060|144187946|SUPERIORITY||Hazard Ratio (HR)|1.32||||0.37|TWO_SIDED|95.0|0.72|2.43|||Regression, Cox||Dexamethasone/intravitreal|||2.43|0.72|0.37
72330832|NCT02374060|144187947|SUPERIORITY||Hazard Ratio (HR)|1.07||||0.92|TWO_SIDED|95.0|0.28|4.01|||Regression, Cox||Intravitreal/Periocular|||4.01|0.28|0.92
72330833|NCT02374060|144187947|SUPERIORITY||Hazard Ratio (HR)|0.71||||0.65|TWO_SIDED|95.0|0.16|3.11|||Regression, Cox||Dexamethasone/Periocular|||3.11|0.16|0.65
72330834|NCT02374060|144187947|SUPERIORITY||Hazard Ratio (HR)|0.64||||0.53|TWO_SIDED|95.0|0.16|2.59|||Regression, Cox||Dexamthasone/Intravitreal|||2.59|0.16|0.53
72330835|NCT01631747|144187976|SUPERIORITY|||||||0.01||||||p-value is not adjusted for multiple comparisons, and tested at an a priori type I error rate of 0.05.|t-test, 2 sided|||Sample size was based on an independent 2-sample t-test using a two-sided type 1 error rate of 0.05, and 80% power. Assuming a standard deviation (SD) of 15lbs (6.8kg), a clinically meaningful difference of 5lbs (2.4kg) between groups, and 10% attrition, a sample size of 150/group was required.||||0.01
72330836|NCT01631747|144187976|SUPERIORITY|||||||0.02|||||||Regression, Linear|adjusted for actual gestational age of 36 week weight, gestational age, bmi, and maternal age at randomization, maternal race and paternal race.||||||0.02
72330837|NCT01631747|144187977|SUPERIORITY|||||||0.54|||||||Chi-squared|||||||0.54
72330838|NCT01631747|144187978|SUPERIORITY|||||||0.89|||||||t-test, 2 sided|T-test performed on change in glucose (log scale), but presented as Median and inter-quartile range for interpretability||||||0.89
72422335|NCT02798211|144355320|SUPERIORITY||Odds Ratio (OR)|6.38||||0.0001|TWO_SIDED|95.0|2.51|16.24|||Regression, Logistic|Statistical analysis (logistic regression) of PASI75 response by visit - in treatment period 1 (non-responder imputation)||secukinumab 150 mg s.c. injection, week 16||16.24|2.51|0.0001
72422336|NCT02798211|144355321|SUPERIORITY||Odds Ratio, log|9.86|||<|0.0001|TWO_SIDED|95.0|3.19|30.45|||Regression, Logistic|Statistical analysis (logistic regression) of PASI90 response in treatment period 1 (non-responder imputation)||secukinumab 300 mg s.c. injection, week 16||30.45|3.19|<.0001
72330839|NCT01631747|144187979|SUPERIORITY|||||||0.3|||||||t-test, 2 sided|t-test performed on changes in HDL, but presented as median and IQR for ease of interpretation||||||0.30
72330840|NCT01631747|144187980|SUPERIORITY|||||||0.69|||||||t-test, 2 sided|t-test run on changes between groups. Data presented as median and IQR for ease of interpretation||||||0.69
72330841|NCT01631747|144187981|SUPERIORITY|||||||0.19|||||||t-test, 2 sided|t-test run on change between groups (log scale), but presented as median and IQR for ease of interpretation||||||0.19
72330842|NCT01631747|144187982|SUPERIORITY|||||||0.27|||||||t-test, 2 sided|t-test used to compare changes between groups (log scale). Median and IQR are presented for ease of interpretation.||||||0.27
72330843|NCT01631747|144187983|SUPERIORITY|||||||0.003|||||||t-test, 2 sided|t-test performed on changes between groups (log scale). Median and IQR are presented for ease of interpretation||||||0.003
72330844|NCT01631747|144187984|SUPERIORITY|||||||0.24|||||||t-test, 2 sided|t-test run on change between groups (log scale), but presented as median and IQR for ease of interpretation||||||0.24
72330845|NCT01631747|144187985|SUPERIORITY|||||||0.32|||||||t-test, 2 sided|t-test run on change between groups (log scale), but presented as median and IQR for ease of interpretation||||||0.32
72330846|NCT01631747|144187986|SUPERIORITY|||||||0.26|||||||t-test, 2 sided|T-test performed on change between groups (log scale). Median and IQR are presented for ease of interpretation||||||0.26
72330847|NCT01631747|144187987|SUPERIORITY|||||||0.62|||||||t-test, 2 sided|||||||0.62
72330848|NCT01631747|144187988|SUPERIORITY|||||||0.61|||||||t-test, 2 sided|||||||0.61
72330849|NCT01631747|144187989|SUPERIORITY|||||||0.42|||||||t-test, 2 sided|||||||0.42
72330850|NCT01631747|144187990|SUPERIORITY|||||||0.25|||||||t-test, 2 sided|||||||0.25
72330851|NCT01631747|144187991|SUPERIORITY|||||||0.66|||||||t-test, 2 sided|||||||0.66
72330852|NCT01631747|144187992|SUPERIORITY|||||||0.94|||||||t-test, 2 sided|||||||0.94
72330853|NCT02908685|144187995|SUPERIORITY|This is the first end point and first family tested in the hierarchical testing. The variables included in the MMRM model are: baseline total score, treatment, age group, visit, treatment-by-visit and baseline score-by-visit interaction.|Least Square Mean Difference|1.55||||0.0156|TWO_SIDED|95.0|0.3|2.81|||Mixed Model Repeated Measure Analysis|||||2.81|0.30|0.0156
72422337|NCT02798211|144355321|SUPERIORITY||Odds Ratio (OR)|5.21||||0.0043|TWO_SIDED|95.0|1.68|16.21|||Regression, Logistic|Statistical analysis (logistic regression) of PASI90 response in treatment period 1 (non-responder imputation)||secukinumab 150 mg s.c. injection, week 16||16.21|1.68|0.0043
72330854|NCT02908685|144187996|SUPERIORITY|This is the second end point and second family tested in the hierarchical testing. Logistic Regression Model.The variables included in the logistic regression are: baseline total score, treatment and age group.|Odds Ratio (OR)|2.35||||0.0469|TWO_SIDED|95.0|1.01|5.44||Adjusted p-Value The adjusted p-values were derived based on all the p-values from end points in order of the hierarchical testing up to the current endpoint.|Wald test|||||5.44|1.01|0.0469
72330855|NCT02908685|144187997|SUPERIORITY|This is the third end point and third family tested in the hierarchical testing. The variables included in the MMRM model are: baseline total score, treatment, age group, visit, treatment-by-visit and baseline score-by-visit interaction.|Least Square Mean Difference|1.59||||0.0469|TWO_SIDED|95.0|0.55|2.62||Adjusted p-Value The adjusted p-values were derived based on all the p-values from end points in order of the hierarchical testing up to the current endpoint.|Mixed Model Repeated Measure Analysis|||||2.62|0.55|0.0469
72330856|NCT02908685|144187998|SUPERIORITY|This is one of the two end points in family four in the hierarchical testing. The variables included in the MMRM model are: baseline total score, treatment, age group, visit, treatment-by-visit and baseline score-by-visit interaction.|Least Square Mean Difference|0.58||||0.3902|TWO_SIDED|95.0|-0.53|1.69||Adjusted p-Value The adjusted p-values were derived based on all the p-values from end points in order of the hierarchical testing up to the current endpoint.|Mixed Model Repeated Measure Analysis|||||1.69|-0.53|0.3902
72330857|NCT02908685|144187999|SUPERIORITY|This is one of the two end points in family four in the hierarchical testing. The variables included in the MMRM model are: baseline total score, treatment, age group, visit, treatment-by-visit and baseline score-by-visit interaction.|Least Square Mean Difference|-2.05||||0.3902|TWO_SIDED|95.0|-6.67|2.56||Adjusted p-Value The adjusted p-values were derived based on all the p-values from end points in order of the hierarchical testing up to the current endpoint.|Mixed Model Repeated Measure Analysis|||||2.56|-6.67|0.3902
72422338|NCT02798211|144355322|SUPERIORITY||Odds Ratio, log|14.38||||0.0107|TWO_SIDED|95.0|1.86|111.53|||Regression, Logistic|Statistical analysis (logistic regression) of PASI100 response by visit in treatment period 1 (non-responder imputation)||secukinumab 300 mg s.c. injection, week 16||111.53|1.86|0.0107
72422339|NCT02798211|144355322|SUPERIORITY||Odds Ratio (OR)|9.82||||0.0307|TWO_SIDED|95.0|1.24|77.9|||Regression, Logistic|Statistical analysis (logistic regression) of PAS100 response by in treatment period 1 (non-responder imputation)||secukinumab 150 mg s.c. injection, week 16||77.90|1.24|0.0307
72422340|NCT02798211|144355323|SUPERIORITY||LS Mean of Treatment Difference|-1.05|||<|0.0001|TWO_SIDED|95.0|-1.45|-0.65|||ANCOVA|Statistical analysis (ANCOVA) of change from baseline in DAS28-CRP score in treatment period 1 (LOCF)||secukinumab 300mg s.c. injection, 16 weeks|"Standard Error of Treatment Difference~0.203"|-0.65|-1.45|<.0001
72422341|NCT02798211|144355323|SUPERIORITY||LS Means of Treatment Difference|-0.83|||<|0.0001|TWO_SIDED|95.0|-1.24|-0.43|||ANCOVA|Statistical analysis (ANCOVA) of change from baseline in DAS28-CRP score in treatment period 1 (LOCF)||secukinumab 150 mg s.c. injection|"LS Mean of Treatment Difference~0.207"|-0.43|-1.24|<.0001
72422342|NCT02798211|144355324|SUPERIORITY||LS Mean of Treatment Difference|-0.21||||0.0107|TWO_SIDED|95.0|-0.37|-0.05|||ANCOVA|Statistical analysis (ANCOVA) of change from baseline in HAQ-DI score by in treatment period 1 (LOCF)||secukinumab 300mg s.c. injection|"Standard Error of Treatment Difference~0.081"|-0.05|-0.37|0.0107
72422343|NCT02798211|144355324|SUPERIORITY|secukinumab 150 mg s.c. injection|LS Mean Treatment Difference|-0.13||||0.1109|TWO_SIDED|95.0|-0.3|0.03|||ANCOVA|Statistical analysis (ANCOVA) of change from baseline in HAQ-DI score by visit - in treatment period 1 (LOCF)|||"Standard Error of Treatment Difference~-0.083"|0.03|-0.30|0.1109
72422344|NCT01982435|144355331|OTHER|Measures were summarized using means, range and standard error of the means (SEM).|||||<|0.05||||||Two-sided paired t-tests and two-sided unpaired t-tests were respectively conducted to analyze efficacy endpoints between study initiation to end, and between monthly and TAE injection regimens.|t-test, 2 sided|||All analyses were performed with a significance level of 0.05 being assumed for all tests.||||<0.05
72330858|NCT02908685|144188000|SUPERIORITY|This is the sixth endpoint and the fifth family tested in the hierarchical testing. The variables included in the MMRM model are: baseline total score, treatment, age group, visit, treatment-by-visit and baseline score-by-visit interaction.|Least Square Mean Difference|2.55||||0.3902|TWO_SIDED|95.0|0.93|4.17||Adjusted p-Value The adjusted p-values were derived based on all the p-values from end points in order of the hierarchical testing up to the current endpoint.|Mixed Model Repeated Measure Analysis|||||4.17|0.93|0.3902
72330859|NCT02908685|144188001|SUPERIORITY|This is the seventh endpoint and the sixth family tested in the hierarchical testing. Logistic Regression Model. The variables included in the logistic regression are: baseline total score, treatment and age group.|Odds Ratio (OR)|1.38||||0.3902|TWO_SIDED|95.0|0.7|2.74||Adjusted p-Value The adjusted p-values were derived based on all the p-values from end points in order of the hierarchical testing up to the current endpoint.|Wald-test|||CGI Improved||2.74|0.70|0.3902
72422345|NCT01892345|144355349|OTHER|Treatment Effect|Hazard Ratio (HR)|0.058|||<|0.0001|TWO_SIDED|95.0|0.017|0.197|||Stratified Log-Rank Test||HR based on a stratified Cox proportional hazards model. Confidence interval = Wald confidence interval. HR for eculizumab compared with placebo represented a 94.2% reduction in the risk of relapse, 95% Wald confidence interval (80.3%, 98.3%).|||0.197|0.017|<0.0001
72422346|NCT01473381|144355356|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.57||||0.0073|TWO_SIDED|95.0|-4.3|-0.84||P-value was adjusted for multiplicity.|Mixed-effect model|||||-0.84|-4.30|0.0073
72422347|NCT01473381|144355356|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.82||||0.0034|TWO_SIDED|95.0|-4.57|-1.06||P-value was adjusted for multiplicity.|Mixed-effect model|||||-1.06|-4.57|0.0034
72330860|NCT02908685|144188002|SUPERIORITY|Logistic Regression Model. The variables included in the logistic regression are: baseline total score, treatment and age group.|Odds Ratio (OR)|2.0||||0.043|TWO_SIDED|95.0|1.02|3.93|||Wald test|||||3.93|1.02|0.0430
72422348|NCT01473381|144355356|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.74||||0.002|TWO_SIDED|95.0|-4.48|-1.0||P-value was provided for assay sensitivity. It was not adjusted for multiplicity.|Mixed-effect model|||||-1.00|-4.48|0.0020
72422349|NCT01473381|144355357|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.35||||0.0073|TWO_SIDED|95.0|-0.58|-0.13||P-value was adjusted for multiplicity.|Mixed-effect model|||||-0.13|-0.58|0.0073
72422350|NCT01473381|144355357|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.33||||0.0097|TWO_SIDED|95.0|-0.55|-0.1||P-value was adjusted for multiplicity.|Mixed-effect model|||||-0.10|-0.55|0.0097
72422351|NCT01473381|144355357|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.35||||0.0025|TWO_SIDED|95.0|-0.57|-0.12||P-value was provided for assay sensitivity. It was not adjusted for multiplicity.|Mixed-effect model|||||-0.12|-0.57|0.0025
72422352|NCT01473381|144355358|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.5||||0.3563|TWO_SIDED|95.0|-3.9|10.9||P-value was adjusted for multiplicity.|Cochran-Mantel-Haenszel|The Mean Difference (Final Values), as well as 95% Confidence Interval, are in units of percentage.||||10.9|-3.9|0.3563
72422353|NCT01473381|144355358|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.1||||0.1611|TWO_SIDED|95.0|-0.4|14.6||P-value was adjusted for multiplicity.|Cochran-Mantel-Haenszel|The Mean Difference (Final Values), as well as 95% Confidence Interval, are in units of percentage.||||14.6|-0.4|0.1611
72330861|NCT02908685|144188004|SUPERIORITY|The variables included in the MMRM model are: baseline total score, treatment, age group, visit, treatment-by-visit and baseline score-by-visit interaction.|Least Square Mean Difference|0.64||||0.1328|TWO_SIDED|95.0|-0.2|1.47|||Mixed Model Repeated Measure Analysis|||||1.47|-0.20|0.1328
72330862|NCT02908685|144188005|SUPERIORITY|The variables included in the MMRM model are: baseline total score, treatment, age group, visit, treatment-by-visit and baseline score-by-visit interaction.|Least Square Mean Difference|1.97||||0.103|TWO_SIDED|95.0|-0.4|4.34|||Mixed Model Repeated Measure Analysis|||||4.34|-0.40|0.1030
72330863|NCT02908685|144188006|SUPERIORITY|The variables included in the MMRM model are: baseline total score, treatment, age group, visit, treatment-by-visit and baseline score-by-visit interaction.|Least Square Mean Difference|2.34||||0.0451|TWO_SIDED|95.0|0.05|4.62|||Mixed Model Repeated Measure Analysis|||||4.62|0.05|0.0451
72330864|NCT02908685|144188007|SUPERIORITY|The variables included in the MMRM model are: baseline total score, treatment, age group, visit, treatment-by-visit and baseline score-by-visit interaction.|Least Square Mean Difference|1.28||||0.0489|TWO_SIDED|95.0|0.01|2.56|||Mixed Model Repeated Measure Analysis|||||2.56|0.01|0.0489
72330865|NCT02908685|144188008|SUPERIORITY|The variables included in the MMRM model are: baseline total score, treatment, age group, visit, treatment-by-visit and baseline score-by-visit interaction.|Least Square Mean Difference|2.16||||0.0326|TWO_SIDED|95.0|0.18|4.14|||Mixed Model Repeated Measure Analysis|||||4.14|0.18|0.0326
72422354|NCT01473381|144355358|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.7||||0.2672|TWO_SIDED|95.0|-2.7|12.2||P-value was provided for assay sensitivity. It was not adjusted for multiplicity.|Cochran-Mantel-Haenszel|The Mean Difference (Final Values), as well as 95% Confidence Interval, are in units of percentage.||||12.2|-2.7|0.2672
72422355|NCT04026165|144355371|SUPERIORITY||Difference in Adjusted Mean|1.2|STANDARD_ERROR_OF_MEAN|0.82||0.1439|TWO_SIDED|95.0|-0.41|2.81|||Random Slope Model|||Estimates were from a random slope model with change in eGFRcr from treatment-specific Baselines at Weeks 4, 8, 12, 24, 36, 48, 60, 72, and 84 as outcome, including terms for treatment-specific Baseline eGFRcr, pre-run-in urine albumin to creatinine ratio (UACR) category (\< 1500 mg/g vs. \>= 1500 mg/g), concomitant use of sodium-glucose co-transporter-2 (SGLT-2) inhibitors at Randomization, treatment group, week, and treatment-by-week interaction, where week has a random effect.||2.81|-0.41|0.1439
72422356|NCT04026165|144355372|SUPERIORITY||Difference in Percentage|0.1||||0.8353|TWO_SIDED|95.0|-10.9|11.4||p-value was based on Cochran-Mantel-Haenszel test stratified by Randomization stratification factors. Randomization stratification factors= pre-run-in eGFRcr stratum, pre-run-in UACR category and concomitant use of SGLT-2 inhibitors at Randomization.|Cochran-Mantel-Haenszel||95% exact CI based on the Santner-Snell method was presented for the difference in proportions between SEL and placebo arms.|||11.4|-10.9|0.8353
72422357|NCT04026165|144355373|SUPERIORITY||Hazard Ratio (HR)|1.48||||0.201|TWO_SIDED|95.0|0.81|2.72|||Stratified Log-Rank|P-value was calculated using a stratified log-rank test, stratified by randomization stratification factors.|Hazard ratio and 95% CI were estimated using a stratified Cox proportional hazard model, stratified by randomization stratification factors and were reported only for outcomes with more than 10 events, and have at least 1 event in each treatment arm.|||2.72|0.81|0.2010
72330866|NCT02908685|144188009|SUPERIORITY|The variables included in the MMRM model are: baseline total score, treatment, age group, visit, treatment-by-visit and baseline score-by-visit interaction.|Least Square Mean Difference|-2.87||||0.3029|TWO_SIDED|95.0|-8.36|2.62|||Mixed Model Repeated Measure Analysis|||||2.62|-8.36|0.3029
72330867|NCT02908685|144188010|SUPERIORITY|The variables included in the MMRM model are: baseline total score, treatment, age group, visit, treatment-by-visit and baseline score-by-visit interaction.|Least Square Mean Difference|1.28||||0.4937|TWO_SIDED|95.0|-2.42|4.99|||Mixed Model Repeated Measure Analysis|||||4.99|-2.42|0.4937
72422358|NCT04026165|144355375|SUPERIORITY||Difference in Adjusted Mean|0.44|STANDARD_ERROR_OF_MEAN|0.72||0.5399|TWO_SIDED|95.0|-0.97|1.86|||Random Slope Model|||Estimates were from a random slope model with change in eGFRcys from pre-run-in Baseline at Weeks 4, 8, 12, 24, 36, 48, 60, 72, and 84 as outcome, including terms for pre-run-in Baseline eGFRcys, pre-run-in UACR category (\< 1500 mg/g vs. \>= 1500 mg/g), concomitant use of SGLT-2 inhibitors at Randomization, treatment group, week, and treatment-by-week interaction, where week has a random effect.||1.86|-0.97|0.5399
72422359|NCT01889186|144355389|SUPERIORITY||||||<|0.001|||||||Clopper-Pearson exact method|||The ORR for ABT-199 was tested to reject the null hypothesis of ORR = 40%. If the null hypothesis is rejected and the ORR is higher than 40%, then ABT-199 has been shown to have an ORR significantly higher than 40%.The p-value is from the exact binomial distribution comparing ABT-199 ORR to the 40% historical control rate.||||<0.001
72422360|NCT01257880|144355403|SUPERIORITY_OR_OTHER|||||||0.39||95.0|||||Wilcoxon (Mann-Whitney)|||Mann-Whitney U test was used to test the null hypothesis that basilar artery vasomotor reactivity was equivalent between the two groups.||||0.39
72422361|NCT04710927|144355428|OTHER||Odds Ratio (OR)|0.7|||<|0.05|TWO_SIDED||||||t-test, 2 sided|||||||<0.05
72422362|NCT04710927|144355428|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
72330868|NCT02908685|144188011|SUPERIORITY|The variables included in the MMRM model are: baseline total score, treatment, age group, visit, treatment-by-visit and baseline score-by-visit interaction.|Least Square Mean Difference|2.35||||0.3967|TWO_SIDED|95.0|-3.11|7.8|||Mixed Model Repeated Measure Analysis|||||7.80|-3.11|0.3967
72330869|NCT02908685|144188012|SUPERIORITY|The variables included in the MMRM model are: baseline total score, treatment, age group, visit, treatment-by-visit and baseline score-by-visit interaction.|Least Square Mean Difference|2.96||||0.6704|TWO_SIDED|95.0|-10.78|16.7|||Mixed Model Repeated Measure Analysis|||||16.70|-10.78|0.6704
72330870|NCT02908685|144188013|SUPERIORITY|The variables included in the MMRM model are: baseline total score, treatment, age group, visit, treatment-by-visit and baseline score-by-visit interaction.|Least Square Mean Difference|-0.43||||0.8856|TWO_SIDED|95.0|-6.3|5.45|||Mixed Model Repeated Measure Analysis|||||5.45|-6.30|0.8856
72330871|NCT02908685|144188014|SUPERIORITY|The variables included in the MMRM model are: baseline total score, treatment, age group, visit, treatment-by-visit and baseline score-by-visit interaction.|Least Square Mean Difference|1.45||||0.1778|TWO_SIDED|95.0|-0.68|3.57|||Mixed Model Repeated Measure Analysis|||||3.57|-0.68|0.1778
72330872|NCT02908685|144188015|SUPERIORITY|Logistic Regression Model. The variables included in the logistic regression are: baseline total score, treatment and age group.|Odds Ratio (OR)|1.21||||0.6636|TWO_SIDED|95.0|0.52|2.83|||Wald-test|||CGI No Change or Improved||2.83|0.52|0.6636
72330873|NCT02370537|144188037|NON_INFERIORITY_OR_EQUIVALENCE|The exposure of a single dose of EPANOVA® 4 g (reference) relative to OMACOR® 4 g (test) was estimated by degree of pancreatic exocrine function using level of FEC. Natural log estimates of least-square means (LSmeans) for each treatment and differences of the LSmeans (OMACOR®-EPANOVA®) along with 90% Confidence Intervals (CIs) by degree of pancreatic exocrine function using level of FEC were exponentiated.|Geometric least-squares (GLS) Mean Ratio|0.75|||||TWO_SIDED|90.0|0.52|1.1|||||OMACOR®/EPANOVA®|Back transformed results are based on the analysis of natural log-transformed data with a Linear Mixed Model containing the terms of FEC classification, treatment, FEC x treatment, sequence, and period as fixed effects and patient nested within sequence as random effect.||1.10|0.52|
72330874|NCT02370537|144188037|NON_INFERIORITY_OR_EQUIVALENCE|The exposure of a single dose of EPANOVA® 4 g (reference) relative to OMACOR® 4 g (test) was estimated by degree of pancreatic exocrine function using level of FEC. Natural log estimates of LSmeans for each treatment and differences of the LSmeans (OMACOR®-EPANOVA®) along with 90% CIs by degree of pancreatic exocrine function using level of FEC were exponentiated.|GLS Mean ratio|0.48|||||TWO_SIDED|90.0|0.32|0.72|||||OMACOR®/EPANOVA®|Back transformed results are based on the analysis of natural log-transformed data with a Linear Mixed Model containing the terms of FEC classification, treatment, FEC x treatment, sequence, and period as fixed effects and patient nested within sequence as random effect.||0.72|0.32|
72330875|NCT02370537|144188037|NON_INFERIORITY_OR_EQUIVALENCE|The exposure of a single dose of EPANOVA® 4 g (reference) relative to OMACOR® 4 g (test) was estimated by degree of pancreatic exocrine function using level of FEC. Natural log estimates of LSmeans for each treatment and differences of the LSmeans (OMACOR®-EPANOVA®) along with 90% CIs by degree of pancreatic exocrine function using level of FEC were exponentiated.|GLS Mean Ratio|0.6|||||TWO_SIDED|90.0|0.44|0.82|||||OMACOR®/EPANOVA®|Back transformed results are based on the analysis of natural log-transformed data with a Linear Mixed Model containing the terms of FEC classification, treatment, FEC x treatment, sequence, and period as fixed effects and patient nested within sequence as random effect.||0.82|0.44|
72330876|NCT02370537|144188038|NON_INFERIORITY_OR_EQUIVALENCE|The exposure of a single dose of EPANOVA® 4 g (reference) relative to OMACOR® 4 g (test) was estimated by degree of pancreatic exocrine function using level of FEC. Natural log estimates of LSmeans for each treatment and differences of the LSmeans (OMACOR®-EPANOVA®) along with 90% CIs by degree of pancreatic exocrine function using level of FEC were exponentiated.|GLS Mean Ratio|1.28|||||TWO_SIDED|90.0|0.84|1.93|||||OMACOR®/EPANOVA®|Back transformed results are based on the analysis of natural log-transformed data with a Linear Mixed Model containing the terms of FEC classification, treatment, FEC x treatment, sequence, and period as fixed effects and patient nested within sequence as random effect.||1.93|0.84|
72330877|NCT02370537|144188038|NON_INFERIORITY_OR_EQUIVALENCE|The exposure of a single dose of EPANOVA® 4 g (reference) relative to OMACOR® 4 g (test) was estimated by degree of pancreatic exocrine function using level of FEC. Natural log estimates of LSmeans for each treatment and differences of the LSmeans (OMACOR®-EPANOVA®) along with 90% CIs by degree of pancreatic exocrine function using level of FEC were exponentiated.|GLS Mean Ratio|0.8|||||TWO_SIDED|90.0|0.51|1.25|||||OMACOR®/EPANOVA®|Back transformed results are based on the analysis of natural log-transformed data with a Linear Mixed Model containing the terms of FEC classification, treatment, FEC x treatment, sequence, and period as fixed effects and patient nested within sequence as random effect.||1.25|0.51|
72422363|NCT02007434|144355447|SUPERIORITY_OR_OTHER||LS Mean Placebo-adjusted Difference|0.24|STANDARD_ERROR_OF_MEAN|0.59||0.6803|TWO_SIDED|95.0|-0.93|1.41|||ANCOVA||Paradigm 1 - Paradigm 2|Pairwise differences between paradigms for the placebo-adjusted differences were conducted using a two-way analysis of covariance (ANCOVA) with factors for treatment, paradigm, treatment-by-paradigm interaction, and covariate of baseline CR-SMFRS score.||1.41|-0.93|0.6803
72422364|NCT02007434|144355447|SUPERIORITY_OR_OTHER||LS Mean Placebo-adjusted Difference|0.39|STANDARD_ERROR_OF_MEAN|0.61||0.5206|TWO_SIDED|95.0|-0.82|1.6|||ANCOVA||Paradigm 1 - Paradigm 3|Day 0, 1 Minute. Pairwise differences between paradigms for the placebo-adjusted differences were conducted using a two-way analysis of covariance (ANCOVA) with factors for treatment, paradigm, treatment-by-paradigm interaction, and covariate of baseline CR-SMFRS score.||1.60|-0.82|0.5206
72422365|NCT02007434|144355447|SUPERIORITY_OR_OTHER||LS Mean Placebo-adjusted Difference|0.3|STANDARD_ERROR_OF_MEAN|0.58||0.606|TWO_SIDED|395.0|-0.86|1.46|||ANCOVA||Paradigm 1 - Paradigm 4|Pairwise differences between paradigms for the placebo-adjusted differences were conducted using a two-way analysis of covariance (ANCOVA) with factors for treatment, paradigm, treatment-by-paradigm interaction, and covariate of baseline CR-SMFRS score.||1.46|-0.86|0.6060
72330878|NCT02370537|144188038|NON_INFERIORITY_OR_EQUIVALENCE|The exposure of a single dose of EPANOVA® 4 g (reference) relative to OMACOR® 4 g (test) was estimated by degree of pancreatic exocrine function using level of FEC. Natural log estimates of LSmeans for each treatment and differences of the LSmeans (OMACOR®-EPANOVA®) along with 90% CIs by degree of pancreatic exocrine function using level of FEC were exponentiated.|GLS Mean Ratio|1.29|||||TWO_SIDED|90.0|0.92|1.82|||||OMACOR®/EPANOVA®|Back transformed results are based on the analysis of natural log-transformed data with a Linear Mixed Model containing the terms of FEC classification, treatment, FEC x treatment, sequence, and period as fixed effects and patient nested within sequence as random effect.||1.82|0.92|
72422366|NCT02007434|144355447|SUPERIORITY_OR_OTHER||LS Mean Placebo-adjusted Difference|0.15|STANDARD_ERROR_OF_MEAN|0.56||0.7935|TWO_SIDED|95.0|-0.98|1.27|||ANCOVA||Paradigm 2 - Paradigm 3|Pairwise differences between paradigms for the placebo-adjusted differences were conducted using a two-way analysis of covariance (ANCOVA) with factors for treatment, paradigm, treatment-by-paradigm interaction, and covariate of baseline CR-SMFRS score.||1.27|-0.98|0.7935
72422367|NCT02007434|144355447|SUPERIORITY_OR_OTHER||LS Mean Placebo-adjusted Difference|0.06|STANDARD_ERROR_OF_MEAN|0.55||0.914|TWO_SIDED|95.0|-1.03|1.15|||ANCOVA||Paradigm 2 - Paradigm 4|Pairwise differences between paradigms for the placebo-adjusted differences were conducted using a two-way analysis of covariance (ANCOVA) with factors for treatment, paradigm, treatment-by-paradigm interaction, and covariate of baseline CR-SMFRS score.||1.15|-1.03|0.9140
72330879|NCT02370537|144188039|NON_INFERIORITY_OR_EQUIVALENCE|The exposure of a single dose of EPANOVA® 4 g (reference) relative to OMACOR® 4 g (test) was estimated by degree of pancreatic exocrine function using level of FEC. Natural log estimates of LSmeans for each treatment and differences of the LSmeans (OMACOR®-EPANOVA®) along with 90% CIs by degree of pancreatic exocrine function using level of FEC were exponentiated.|GLS Mean Ratio|0.9|||||TWO_SIDED|90.0|0.63|1.28|||||OMACOR®/EPANOVA®|Back transformed results are based on the analysis of natural log-transformed data with a Linear Mixed Model containing the terms of FEC classification, treatment, FEC x treatment, sequence, and period as fixed effects and patient nested within sequence as random effect.||1.28|0.63|
72330880|NCT02370537|144188039|NON_INFERIORITY_OR_EQUIVALENCE|The exposure of a single dose of EPANOVA® 4 g (reference) relative to OMACOR® 4 g (test) was estimated by degree of pancreatic exocrine function using level of FEC. Natural log estimates of LSmeans for each treatment and differences of the LSmeans (OMACOR®-EPANOVA®) along with 90% CIs by degree of pancreatic exocrine function using level of FEC were exponentiated.|GLS Mean Ratio|0.58|||||TWO_SIDED|90.0|0.39|0.85|||||OMACOR®/EPANOVA®|Back transformed results are based on the analysis of natural log-transformed data with a Linear Mixed Model containing the terms of FEC classification, treatment, FEC x treatment, sequence, and period as fixed effects and patient nested within sequence as random effect.||0.85|0.39|
72330881|NCT02370537|144188039|NON_INFERIORITY_OR_EQUIVALENCE|The exposure of a single dose of EPANOVA® 4 g (reference) relative to OMACOR® 4 g (test) was estimated by degree of pancreatic exocrine function using level of FEC. Natural log estimates of LSmeans for each treatment and differences of the LSmeans (OMACOR®-EPANOVA®) along with 90% CIs by degree of pancreatic exocrine function using level of FEC were exponentiated.|GLS Mean Ratio|0.75|||||TWO_SIDED|90.0|0.55|1.0|||||OMACOR®/EPANOVA®|Back transformed results are based on the analysis of natural log-transformed data with a Linear Mixed Model containing the terms of FEC classification, treatment, FEC x treatment, sequence, and period as fixed effects and patient nested within sequence as random effect.||1.00|0.55|
72330882|NCT02370537|144188040|NON_INFERIORITY_OR_EQUIVALENCE|The exposure of a single dose of EPANOVA® 4 g (reference) relative to OMACOR® 4 g (test) was estimated by degree of pancreatic exocrine function using level of FEC. Natural log estimates of LSmeans for each treatment and differences of the LSmeans (OMACOR®-EPANOVA®) along with 90% CIs by degree of pancreatic exocrine function using level of FEC were exponentiated.|GLS Mean Ratio|0.52|||||TWO_SIDED|90.0|0.37|0.73|||||OMACOR®/EPANOVA®|Back transformed results are based on the analysis of natural log-transformed data with a Linear Mixed Model containing the terms of FEC classification, treatment, FEC x treatment, sequence, and period as fixed effects and patient nested within sequence as random effect.||0.73|0.37|
72368963|NCT02453711|144247819|OTHER||Treatment difference (%-points)|-11.55|STANDARD_ERROR_OF_MEAN|1.12|<|0.0001|TWO_SIDED|95.0|-14.38|-8.72|||ANCOVA||Semaglutide 0.4 mg - placebo pool|J2R-MI: Analysis of in-trial data with missing observations imputed from the pooled placebo arms based on a jump to reference multiple (x1000) imputation (J2R-MI) approach. Week 52 responses were analysed using an analysis of covariance model with treatment, region and sex as factors and baseline body weight as covariate. Dunnett's method was used to adjust for multiple comparisons.||-8.72|-14.38|<0.0001
72368964|NCT04292899|144247883|SUPERIORITY||Odds Ratio (OR)|0.75||||0.1563|TWO_SIDED|95.0|0.507|1.115||P-value was calculated using a proportional odds model with treatment as the independent variable and baseline clinical status as a continuous covariate.|Proportional odds model|||||1.115|0.507|0.1563
72330883|NCT02370537|144188040|NON_INFERIORITY_OR_EQUIVALENCE|The exposure of a single dose of EPANOVA® 4 g (reference) relative to OMACOR® 4 g (test) was estimated by degree of pancreatic exocrine function using level of FEC. Natural log estimates of LSmeans for each treatment and differences of the LSmeans (OMACOR®-EPANOVA®) along with 90% CIs by degree of pancreatic exocrine function using level of FEC were exponentiated.|GLS Mean Ratio|0.46|||||TWO_SIDED|90.0|0.32|0.67|||||OMACOR®/EPANOVA®|Back transformed results are based on the analysis of natural log-transformed data with a Linear Mixed Model containing the terms of FEC classification, treatment, FEC x treatment, sequence, and period as fixed effects and patient nested within sequence as random effect.||0.67|0.32|
72330884|NCT02370537|144188040|NON_INFERIORITY_OR_EQUIVALENCE|The exposure of a single dose of EPANOVA® 4 g (reference) relative to OMACOR® 4 g (test) was estimated by degree of pancreatic exocrine function using level of FEC. Natural log estimates of LSmeans for each treatment and differences of the LSmeans (OMACOR®-EPANOVA®) along with 90% CIs by degree of pancreatic exocrine function using level of FEC were exponentiated.|GLS Mean Ratio|0.53|||||TWO_SIDED|90.0|0.4|0.7|||||OMACOR®/EPANOVA®|Back transformed results are based on the analysis of natural log-transformed data with a Linear Mixed Model containing the terms of FEC classification, treatment, FEC x treatment, sequence, and period as fixed effects and patient nested within sequence as random effect.||0.70|0.40|
72330885|NCT02370537|144188041|NON_INFERIORITY_OR_EQUIVALENCE|The exposure of a single dose of EPANOVA® 4 g (reference) relative to OMACOR® 4 g (test) was estimated by degree of pancreatic exocrine function using level of FEC. Natural log estimates of least-squares LSmeans for each treatment and differences of the LSmeans (OMACOR®-EPANOVA®) along with 90% CIs by degree of pancreatic exocrine function using level of FEC were exponentiated.|GLS Mean Ratio|1.02|||||TWO_SIDED|90.0|0.77|1.36|||||OMACOR®/EPANOVA®|Back transformed results are based on the analysis of natural log-transformed data with a Linear Mixed Model containing the terms of FEC classification, treatment, FEC x treatment, sequence, and period as fixed effects and patient nested within sequence as random effect.||1.36|0.77|
72330886|NCT02370537|144188041|NON_INFERIORITY_OR_EQUIVALENCE|The exposure of a single dose of EPANOVA® 4 g (reference) relative to OMACOR® 4 g (test) was estimated by degree of pancreatic exocrine function using level of FEC. Natural log estimates of LSmeans for each treatment and differences of the LSmeans (OMACOR®-EPANOVA®) along with 90% CIs by degree of pancreatic exocrine function using level of FEC were exponentiated.|GLS mean Ratio|0.92|||||TWO_SIDED|90.0|0.67|1.25|||||OMACOR®/EPANOVA®|Back transformed results are based on the analysis of natural log-transformed data with a Linear Mixed Model containing the terms of FEC classification, treatment, FEC x treatment, sequence, and period as fixed effects and patient nested within sequence as random effect.||1.25|0.67|
72368965|NCT04292899|144247883|SUPERIORITY||Odds Ratio (OR)|0.67||||0.0368|TWO_SIDED|95.0|0.458|0.976||P-value was calculated using a proportional odds model with treatment as the independent variable.|Proportional odds model|||||0.976|0.458|0.0368
72368966|NCT04292899|144247884|SUPERIORITY||Difference in Percentages|1.3||||0.7678|TWO_SIDED|95.0|-7.4|10.0||P-value for comparison of the percentages between the two groups was calculated using the Cochran-Mantel-Haenszel test stratified on baseline clinical status.|Cochran-Mantel-Haenszel|||||10.0|-7.4|0.7678
72422368|NCT02007434|144355447|SUPERIORITY_OR_OTHER||LS Mean Placebo-adjusted Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.56||0.8754|TWO_SIDED|95.0|-1.21|1.04|||ANCOVA||Paradigm 3 - Paradigm 4|Pairwise differences between paradigms for the placebo-adjusted differences were conducted using a two-way analysis of covariance (ANCOVA) with factors for treatment, paradigm, treatment-by-paradigm interaction, and covariate of baseline CR-SMFRS score.||1.04|-1.21|0.8754
72422369|NCT01287611|144355458|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Group sample sizes of 51 in study group and 65 in control group achieve 98% power to detect a difference between the group proportions of -0.3300. The proportion in study group is assumed to be 0.4800 under the null hypothesis and 0.1500 under the alternative hypothesis. The proportion in control group is 0.4800. The test statistic used is the two-sided Z test with pooled variance. The significance level of the test was targeted at 0.0500.||||||0.0001|||||||Chi-squared|||||||0.0001
72422370|NCT01287611|144355459|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Group sample sizes of 51 in study group and 65 in control group achieve 98% power to detect a difference between the group proportions of -0.3300. The proportion in study group is assumed to be 0.4800 under the null hypothesis and 0.1500 under the alternative hypothesis. The proportion in control group is 0.4800. The test statistic used is the two-sided Z test with pooled variance. The significance level of the test was targeted at 0.0500.||||||0.001|||||||t-test, 2 sided|||||||0.001
72422371|NCT01856712|144355460|SUPERIORITY||Odds Ratio (OR)|1.71|||||TWO_SIDED|95.0|0.35|9.98||||||||9.98|0.35|
72422372|NCT03299686|144355479|SUPERIORITY||Mean Difference (Net)|0.027|STANDARD_DEVIATION|0.043||0.7374|TWO_SIDED|80.0|-0.029|0.082||Probability CJM112 better than placebo|Bayesian linear repeated measures model||||Lower limit and upper limit represents the Credibility Interval from the Bayesian analysis.|0.082|-0.029|0.7374
72422373|NCT03299686|144355480|SUPERIORITY||Mean Difference (Net)|0.913|STANDARD_ERROR_OF_MEAN|1.434||0.263|TWO_SIDED|80.0|-0.939|2.766||1-sided p-value; p-value smaller than 0.1 is considered as statistically significant|Mixed Models Analysis|||||2.766|-0.939|0.263
72368967|NCT02469870|144247890|SUPERIORITY|||||||0.598|||||||ANCOVA|||To address hypotheses predicting differential change in outcome measures between condition over time we used analysis of covariance (ANCOVA) models that allow for examination of cross-sectional effects and mean adjusted outcomes. The ANCOVA models (adjusted for baseline scores) were used for analyses of change in the outcome measures at posttest.||||.598
72368968|NCT02469870|144247891|SUPERIORITY|||||||0.81|||||||ANCOVA|||. To address hypotheses predicting differential change in outcome measures between condition over time we used analysis of covariance (ANCOVA) models that allow for examination of cross-sectional effects and mean adjusted outcomes. The ANCOVA models (adjusted for baseline scores) were used for analyses of change in the outcome measures at posttest.||||.81
72422374|NCT03299686|144355481|SUPERIORITY||Mean Difference (Net)|-0.22|STANDARD_ERROR_OF_MEAN|0.14||0.061|TWO_SIDED|80.0|-0.41|-0.04||1-sided p-value; p-value smaller than 0.1 is considered as statistically significant|Mixed Models Analysis|||||-0.04|-0.41|0.061
72422375|NCT03299686|144355482|SUPERIORITY||Mean Difference (Net)|-0.23|STANDARD_ERROR_OF_MEAN|0.13||0.04|TWO_SIDED|80.0|-0.4|-0.06||1-sided p-value; p-value smaller than 0.1 is considered as statistically significant|Mixed Models Analysis|||||-0.06|-0.40|0.040
72422376|NCT02709005|144355485|SUPERIORITY||Risk Difference (RD)|-0.08||||0.42|TWO_SIDED|95.0|-0.26|0.08||The test was conducted using a Fisher's exact test at the 5% two-sided level of significance level without adjustment for multiplicity.|Fisher Exact||Difference in Proportion of Participants with Clinical Cure between 5% Monolaurin Vaginal Gel and Placebo Gel|The null hypothesis was that there was no difference in participants with clinical cure between study arms, with a two-sided alternative considering the possibility of a difference in either direction. The statistical informational goal for the study of 90 participants eligible in the modified Intent-to-Treat (mITT) efficacy population was an ad-hoc sample size determined by logistical considerations, as there was insufficient pilot data upon which to base more formal sample size calculations.||0.08|-0.26|0.420
72422377|NCT02709005|144355486|SUPERIORITY||Risk Difference (RD)|0.14||||0.2|TWO_SIDED|95.0|-0.06|0.33||The test was conducted using a Fisher's exact test at the 5% two-sided level of significance level without adjustment for multiplicity.|Fisher Exact||Difference in Proportion of Participants Experiencing Solicited Events between 5% Monolaurin Vaginal Gel and Placebo Gel|The null hypothesis was that there was no difference in participants with solicited urogenital AEs between study arms, with a two-sided alternative considering the possibility of a difference in either direction.||0.33|-0.06|0.200
72422378|NCT02709005|144355487|SUPERIORITY||Risk Difference (RD)|0.0|||||TWO_SIDED|||||No SAEs were reported; therefore the Fisher's Exact Test was not performed.||||The null hypothesis was that there was no difference in participants with related SAEs between study arms, with a two-sided alternative considering the possibility of a difference in either direction.||||
72330887|NCT02370537|144188041|NON_INFERIORITY_OR_EQUIVALENCE|The exposure of a single dose of EPANOVA® 4 g (reference) relative to OMACOR® 4 g (test) was estimated by degree of pancreatic exocrine function using level of FEC. Natural log estimates of LSmeans for each treatment and differences of the LSmeans (OMACOR®-EPANOVA®) along with 90% CIs by degree of pancreatic exocrine function using level of FEC were exponentiated.|GLS Mean Ratio|1.11|||||TWO_SIDED|90.0|0.88|1.4|||||OMACOR®/EPANOVA®|Back transformed results are based on the analysis of natural log-transformed data with a Linear Mixed Model containing the terms of FEC classification, treatment, FEC x treatment, sequence, and period as fixed effects and patient nested within sequence as random effect.||1.40|0.88|
72330888|NCT02370537|144188042|NON_INFERIORITY_OR_EQUIVALENCE|The exposure of a single dose of EPANOVA® 4 g (reference) relative to OMACOR® 4 g (test) was estimated by degree of pancreatic exocrine function using level of FEC. Natural log estimates of LSmeans for each treatment and differences of the LSmeans (OMACOR®-EPANOVA®) along with 90% CIs by degree of pancreatic exocrine function using level of FEC were exponentiated.|GLS Mean|0.68|||||TWO_SIDED|90.0|0.49|0.92|||||OMACOR®/EPANOVA®|Back transformed results are based on the analysis of natural log-transformed data with a Linear Mixed Model containing the terms of FEC classification, treatment, FEC x treatment, sequence, and period as fixed effects and patient nested within sequence as random effect.||0.92|0.49|
72368969|NCT02469870|144247892|SUPERIORITY|||||||0.404|||||||ANCOVA|||. To address hypotheses predicting differential change in outcome measures between condition over time we used analysis of covariance (ANCOVA) models that allow for examination of cross-sectional effects and mean adjusted outcomes. The ANCOVA models (adjusted for baseline scores) were used for analyses of change in the outcome measures at posttest.||||.404
72368970|NCT02469870|144247893|SUPERIORITY|||||||0.246|||||||ANCOVA|||. To address hypotheses predicting differential change in outcome measures between condition over time we used analysis of covariance (ANCOVA) models that allow for examination of cross-sectional effects and mean adjusted outcomes. The ANCOVA models (adjusted for baseline scores) were used for analyses of change in the outcome measures at posttest.||||.246
72368971|NCT02469870|144247894|SUPERIORITY|||||||0.007|||||||ANCOVA|||. To address hypotheses predicting differential change in outcome measures between condition over time we used analysis of covariance (ANCOVA) models that allow for examination of cross-sectional effects and mean adjusted outcomes. The ANCOVA models (adjusted for baseline scores) were used for analyses of change in the outcome measures at posttest.||||.007
72368972|NCT02469870|144247895|SUPERIORITY|||||||0.045|||||||t-test, 2 sided|||Two-sample t-test||||.045
72368973|NCT01600170|144247896|SUPERIORITY|||||||0.39||||||The threshold for statistical significance was p = 0.01|Mixed Models Analysis|||Analysis focused on a comparison of change in response over 12 wks for each treatment under a 2x2 crossover design. Mixed effects model was used to estimate within subject treatment differences, trends over time \& at each wk(0,2,6,12). Log-transformations were applied to meet normality assumption \& models adjusted for period \& sequence effects. Primary outcomes were pre-specified to use p\<0.01 for statistical significance. All other analyses used p\<0.05 after adjustment for multiple comparisons.||||0.39
72369567|NCT00829504|144249563|NON_INFERIORITY_OR_EQUIVALENCE|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|102.1||||||90.0|95.64|109.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||109|95.64|
72369568|NCT00912197|144249573|SUPERIORITY|||||||0.135|||||||ANCOVA|||||||0.135
72368974|NCT01600170|144247897|SUPERIORITY||||||<|0.45||||||Threshold of statistical significance was p=0.01|Mixed Models Analysis|||Analysis focused on a comparison of change in response over 12 wks for each treatment under a 2x2 crossover design. Mixed effects model was used to estimate within subject treatment differences, trends over time \& at each wk(0,2,6,12). Log-transformations were applied to meet normality assumption \& models adjusted for period \& sequence effects. Primary outcomes were pre-specified to use p\<0.01 for statistical significance. All other analyses used p\<0.05 after adjustment for multiple comparisons.||||<0.45
72368975|NCT01600170|144247898|SUPERIORITY|||||||0.8||||||The threshold for statistical significance was p = 0.01|Mixed Models Analysis|||Analysis focused on a comparison of change in response over 12 wks for each treatment under a 2x2 crossover design. Mixed effects model was used to estimate within subject treatment differences, trends over time \& at each wk(0,2,6,12). Log-transformations were applied to meet normality assumption \& models adjusted for period \& sequence effects. Primary outcomes were pre-specified to use p\<0.01 for statistical significance. All other analyses used p\<0.05 after adjustment for multiple comparisons.||||0.80
72368976|NCT01600170|144247899|SUPERIORITY|||||||0.04||||||The threshold of statistical significance was p=0.01|Mixed Models Analysis|||Analysis focused on a comparison of change in response over 12 wks for each treatment under a 2x2 crossover design. Mixed effects model was used to estimate within subject treatment differences, trends over time \& at each wk(0,2,6,12). Log-transformations were applied to meet normality assumption \& models adjusted for period \& sequence effects. Primary outcomes were pre-specified to use p\<0.01 for statistical significance. All other analyses used p\<0.05 after adjustment for multiple comparisons.||||0.04
72368977|NCT01600170|144247900|SUPERIORITY|||||||0.15||||||The threshold of statistical significance was p=0.01|Mixed Models Analysis|||Analysis focused on a comparison of change in response over 12 wks for each treatment under a 2x2 crossover design. Mixed effects model was used to estimate within subject treatment differences, trends over time \& at each wk(0,2,6,12). Log-transformations were applied to meet normality assumption \& models adjusted for period \& sequence effects. Primary outcomes were pre-specified to use p\<0.01 for statistical significance. All other analyses used p\<0.05 after adjustment for multiple comparisons.||||0.15
72368978|NCT01600170|144247901|SUPERIORITY|||||||0.63||||||The threshold for statistical significance was p = 0.05|Mixed Models Analysis|||Analysis focused on a comparison of change in response over 12 wks for each treatment under a 2x2 crossover design. Mixed effects model was used to estimate within subject treatment differences, trends over time \& at each wk(0,2,6,12). Log-transformations were applied to meet normality assumption \& models adjusted for period \& sequence effects. Secondary outcome analyses used p\<0.05 for statistical significance after adjustment for multiple comparisons.||||0.63
72368979|NCT01600170|144247902|SUPERIORITY|||||||0.035||||||Threshold for statistical significance was p = 0.05|Mixed Models Analysis|||Analysis focused on a comparison of change in response over 12 wks for each treatment under a 2x2 crossover design. Mixed effects model was used to estimate within subject treatment differences, trends over time \& at each wk(0,2,6,12). Log-transformations were applied to meet normality assumption \& models adjusted for period \& sequence effects. Secondary outcome analyses used p\<0.05 for statistical significance after adjustment for multiple comparisons.||||0.035
72369569|NCT00912197|144249574|SUPERIORITY|||||||0.688|||||||ANCOVA|||||||0.688
72369570|NCT00912197|144249575|SUPERIORITY|||||||0.715|||||||t-test, 2 sided|||after treatment, 56 days||||0.715
72369571|NCT00912197|144249576|SUPERIORITY|||||||0.578|||||||ANCOVA|||||||0.578
72369572|NCT00912197|144249576|SUPERIORITY|||||||0.007|||||||t-test, 2 sided|||baseline to after treatment, at 56 days||||0.007
72369573|NCT00912197|144249576|SUPERIORITY|||||||0.05||||||calculated|t-test, 2 sided|||baseline to after treatment, at 56 days||||0.05
72369574|NCT00912197|144249580|SUPERIORITY|||||||0.024|||||||ANCOVA|||Acetate||||0.024
72330889|NCT02370537|144188042|NON_INFERIORITY_OR_EQUIVALENCE|The exposure of a single dose of EPANOVA® 4 g (reference) relative to OMACOR® 4 g (test) was estimated by degree of pancreatic exocrine function using level of FEC. Natural log estimates of LSmeans for each treatment and differences of the LSmeans (OMACOR®-EPANOVA®) along with 90% CIs by degree of pancreatic exocrine function using level of FEC were exponentiated.|GLS Mean Ratio|0.6|||||TWO_SIDED|90.0|0.42|0.84|||||OMACOR®/EPANOVA®|Back transformed results are based on the analysis of natural log-transformed data with a Linear Mixed Model containing the terms of FEC classification, treatment, FEC x treatment, sequence, and period as fixed effects and patient nested within sequence as random effect.||0.84|0.42|
72330890|NCT02370537|144188042|NON_INFERIORITY_OR_EQUIVALENCE|The exposure of a single dose of EPANOVA® 4 g (reference) relative to OMACOR® 4 g (test) was estimated by degree of pancreatic exocrine function using level of FEC. Natural log estimates of LSmeans for each treatment and differences of the LSmeans (OMACOR®-EPANOVA®) along with 90% CIs by degree of pancreatic exocrine function using level of FEC were exponentiated.|GLS Mean Ratio|0.7|||||TWO_SIDED|90.0|0.54|0.9|||||OMACOR®/EPANOVA®|Back transformed results are based on the analysis of natural log-transformed data with a Linear Mixed Model containing the terms of FEC classification, treatment, FEC x treatment, sequence, and period as fixed effects and patient nested within sequence as random effect.||0.90|0.54|
72330891|NCT01691014|144188050|SUPERIORITY_OR_OTHER|||||||0.99|||||||Fisher Exact|||DAS28: Month 3: Continuous variables were compared between treatment groups using one way analysis of variance (ANOVA).||||0.990
72330892|NCT01691014|144188050|SUPERIORITY_OR_OTHER|||||||0.586|||||||Fisher Exact|||DAS28: Month 6: Continuous variables were compared between treatment groups using one way ANOVA.||||0.586
72330893|NCT01691014|144188050|SUPERIORITY_OR_OTHER|||||||0.98|||||||Fisher Exact|||DAS28: Month 12: Continuous variables were compared between treatment groups using one way ANOVA.||||0.980
72330894|NCT01691014|144188051|SUPERIORITY_OR_OTHER|||||||0.945|||||||Fisher Exact|||HAQ: Baseline: Continuous variables were compared between treatment groups using one way ANOVA.||||0.945
72330895|NCT01691014|144188051|SUPERIORITY_OR_OTHER|||||||0.458|||||||Fisher Exact|||HAQ: Month 3: Continuous variables were compared between treatment groups using one way ANOVA.||||0.458
72422379|NCT02709005|144355488|SUPERIORITY||Risk Difference (RD)|0.0|||>|0.999|TWO_SIDED|95.0|-0.13|0.08||The test was conducted using a Fisher's exact test at the 5% two-sided level of significance level without adjustment for multiplicity.|Fisher Exact||Difference in Proportion of Participants with Therapeutic Cure between 5% Monolaurin Vaginal Gel and Placebo Gel|The null hypothesis was that there was no difference in participants with therapeutic cure between study arms, with a two-sided alternative considering the possibility of a difference in either direction.||0.08|-0.13|>0.999
72330896|NCT01691014|144188051|SUPERIORITY_OR_OTHER|||||||0.896|||||||Fisher Exact|||HAQ: Month 6: Continuous variables were compared between treatment groups using one way ANOVA.||||0.896
72422380|NCT02709005|144355489|SUPERIORITY||Risk Difference (RD)|-0.09||||0.035|TWO_SIDED|95.0|-0.24|-0.01||The test was conducted using a Fisher's exact test at the 5% two-sided level of significance level without adjustment for multiplicity.|Fisher Exact||Difference in Proportion of Participants with Therapeutic Cure between 5% Monolaurin Vaginal Gel and Placebo Gel|The null hypothesis was that there was no difference in participants with therapeutic cure between study arms, with a two-sided alternative considering the possibility of a difference in either direction.||-0.01|-0.24|0.035
72330897|NCT01691014|144188051|SUPERIORITY_OR_OTHER|||||||0.39|||||||Fisher Exact|||HAQ: Month 12: Continuous variables were compared between treatment groups using one way ANOVA.||||0.390
72330898|NCT05791565|144188148|OTHER||Ratio of Geometric LS Means|1.1609|||||TWO_SIDED|90.0|1.0221|1.3185|||||Ratio of the Geometric LS means = Geometric LS mean of the Salbutamol HFA-152a MDI to the Geometric LS mean of the Salbutamol HFA-134a MDI.|||1.3185|1.0221|
72330899|NCT05791565|144188149|OTHER||Ratio of the Geometric LS Means|1.4081|||||TWO_SIDED|90.0|1.2998|1.5255|||||Ratio of the Geometric LS means = Geometric LS mean of the Salbutamol HFA-152a MDI to the Geometric LS mean of the Salbutamol HFA-134a MDI.|||1.5255|1.2998|
72330900|NCT05791565|144188150|OTHER||Ratio of the Geometric LS Means|1.3885|||||TWO_SIDED|90.0|1.2793|1.507|||||Ratio of the Geometric LS means = Geometric LS mean of the Salbutamol HFA-152a MDI to the Geometric LS mean of the Salbutamol HFA-134a MDI.|||1.5070|1.2793|
72330901|NCT05791565|144188151|OTHER||Ratio of the Geometric LS Means|1.3141|||||TWO_SIDED|90.0|1.1816|1.4614|||||Ratio of the Geometric LS means = Geometric LS mean of the Salbutamol HFA-152a MDI to the Geometric LS mean of the Salbutamol HFA-134a MDI.|||1.4614|1.1816|
72330902|NCT02388165|144188179|SUPERIORITY||Vaccine Efficacy (VE)|0.0|||||TWO_SIDED|95.0|-126.3|55.81|||||VE was calculated as 1-(P/\[1-P\]\*100), where P is the number of SA4Ag cases divided by the total number of cases. The confidence interval (CI) was calculated using the Clopper-Pearson method.|||55.81|-126.30|
72330903|NCT02388165|144188180|SUPERIORITY||Difference in percentage of participants|8.3|||<|0.001|TWO_SIDED|95.0|6.9|9.8|||Miettinen and Nurminen|||Redness: Any||9.8|6.9|<0.001
72330904|NCT02388165|144188180|SUPERIORITY||Difference in percentage of participants|4.4|||||TWO_SIDED|95.0|3.3|5.6||||||Redness: Mild||5.6|3.3|
72330905|NCT02388165|144188180|SUPERIORITY||Difference in percentage of participants|3.0|||||TWO_SIDED|95.0|2.3|4.0||||||Redness: Moderate||4.0|2.3|
72330906|NCT02388165|144188180|SUPERIORITY||Difference in percentage of participants|0.8|||||TWO_SIDED|95.0|0.5|1.4||||||Redness: Severe||1.4|0.5|
72330907|NCT02388165|144188180|SUPERIORITY||Difference in percentage of participants|7.0|||<|0.001|TWO_SIDED|95.0|5.7|8.4|||Miettinen and Nurminen|||Swelling: Any||8.4|5.7|<0.001
72330908|NCT02388165|144188180|SUPERIORITY||Difference in percentage of participants|3.9|||||TWO_SIDED|95.0|2.8|5.0||||||Swelling: Mild||5.0|2.8|
72330909|NCT02388165|144188180|SUPERIORITY||Difference in percentage of participants|2.4|||||TWO_SIDED|95.0|1.7|3.3||||||Swelling: Moderate||3.3|1.7|
72330910|NCT02388165|144188180|SUPERIORITY||Difference in percentage of participants|0.7|||||TWO_SIDED|95.0|0.4|1.2||||||Swelling: Severe||1.2|0.4|
72330911|NCT02388165|144188180|SUPERIORITY||Difference in percentage of participants|15.7|||<|0.001|TWO_SIDED|95.0|13.3|18.1|||Miettinen and Nurminen|||Pain at the injection site: Any||18.1|13.3|<0.001
72330912|NCT02388165|144188180|SUPERIORITY||Difference in percentage of participants|12.2|||||TWO_SIDED|95.0|10.0|14.5||||||Pain at the injection site: Mild||14.5|10.0|
72422381|NCT02709005|144355494|SUPERIORITY||Risk Difference (RD)|0.0|||>|0.999|TWO_SIDED|95.0|-0.18|0.14||The test was conducted using a Fisher's exact test at the 5% two-sided level of significance level without adjustment for multiplicity.|Fisher Exact||Difference in Proportion of Participants with Clinical Cure between 5% Monolaurin Vaginal Gel and Placebo Gel|The null hypothesis was that there was no difference in participants with clinical cure between study arms, with a two-sided alternative considering the possibility of a difference in either direction.||0.14|-0.18|>0.999
72422382|NCT00860067|144355547|NON_INFERIORITY_OR_EQUIVALENCE|The immune response of Q/LAIV was to be declared noninferior to that of trivalent FluMist if the upper bound of the 95% CI for post dose A/H1N1 GMT ratio was ≤ 1.5. This corresponded to the statistical hypothesis of: Ho: Rj \> 1.5 for any j and Ha: Rj ≤ 1.5 for all j, where Rj was the A/H1N1 post-dose GMT ratio: (FluMist B/Yamagata A/H1N1 + FluMist B/Victoria A/H1N1) divided by Q/LAIV A/H1N1.|Ratio of geometric mean|1.09|||||TWO_SIDED|95.0|1.01|1.18|||Bootstrapping|Confidence intervals calculated based on bootstrapping method.||A/H1N1: Noninferior immune response was assessed by evaluating the upper bound of the 2-sided 95% CI for the ratio of A/H1N1 GMTs for the specified comparison. Geometric mean titers for the A/H1N1 influenza antibody measurements were calculated as: GMT = antilog\^e (mean \[log\^e x\]) where x was the assay result and e was the natural logarithm.||1.18|1.01|
72422383|NCT00860067|144355547|NON_INFERIORITY_OR_EQUIVALENCE|The immune response of Q/LAIV was to be declared noninferior to that of trivalent FluMist if the upper bound of the 95% CI for post dose A/H3N2 GMT ratio was ≤ 1.5. This corresponded to the statistical hypothesis of: Ho: Rj \> 1.5 for any j and Ha: Rj ≤ 1.5 for all j, where Rj was the A/H3N2 post-dose GMT ratio: (FluMist B/Yamagata A/H3N2 + FluMist B/Victoria A/H3N2) divided by Q/LAIV A/H3N2.|Ratio of geometric means|1.05|||||TWO_SIDED|95.0|0.96|1.14|||Bootstrapping|Confidence intervals calculated based on bootstrapping method.||A/H3N2: Noninferior immune response was assessed by evaluating the upper bound of the 2-sided 95% CI for the ratio of A/H3N2 GMTs for the specified comparison. Geometric mean titers for the A/H3N2 influenza antibody measurements were calculated as: GMT = antilog\^e (mean \[log\^e x\]) where x was the assay result and e was the natural logarithm.||1.14|0.96|
72422384|NCT00860067|144355547|NON_INFERIORITY_OR_EQUIVALENCE|The immune response of Q/LAIV was to be declared noninferior to that of trivalent FluMist if the upper bound of the 95% CI for post dose B/Yamagata GMT ratio was ≤ 1.5. This corresponded to the statistical hypothesis of: Ho: Rj \> 1.5 for any j and Ha: Rj ≤ 1.5 for all j, where Rj was the B/Yamagata post-dose GMT ratio: (FluMist B/Yamagata) divided by (Q/LAIV B/Yamagata).|Ratio of geometric mean|1.1|||||TWO_SIDED|95.0|0.97|1.25|||Bootstrapping|Confidence intervals calculated based on bootstrapping method.||Noninferior immune response was assessed by evaluating the upper bound of the 2-sided 95% CI for the ratio of B/Yamagata GMTs for the specified comparison. Geometric mean titers for the B/Yamagata influenza antibody measurements were calculated as: GMT = antilog\^e (mean \[log\^e x\]) where x was the assay result and e was the natural logarithm.||1.25|0.97|
72422385|NCT00860067|144355547|NON_INFERIORITY_OR_EQUIVALENCE|The immune response of Q/LAIV was to be declared noninferior to that of trivalent FluMist if the upper bound of the 95% CI for post dose B/Victoria GMT ratio was ≤ 1.5. This corresponded to the statistical hypothesis of: Ho: Rj \> 1.5 for any j and Ha: Rj ≤ 1.5 for all j, where Rj was the B/Victoria post-dose GMT ratio: (FluMist B/Victoria) divided by (Q/LAIV B/Victoria).|Ratio of geometric means|0.92|||||TWO_SIDED|95.0|0.82|1.03|||Bootstrapping|Confidence intervals were calculated based on bootstrapping method.||Noninferior immune response was assessed by evaluating the upper bound of the 2-sided 95% CI for the ratio of B/Victoria GMTs for the specified comparison. Geometric mean titers for the B/Victoria influenza antibody measurements were calculated as: GMT = antilog\^e (mean \[log\^e x\]) where x was the assay result and e was the natural logarithm.||1.03|0.82|
72422386|NCT00560612|144355577|SUPERIORITY|||||||0.7054|||||||t-test, 2 sided|||||||0.7054
72422387|NCT00560612|144355578|SUPERIORITY|||||||0.4583|||||||t-test, 2 sided|||||||0.4583
72422388|NCT00560612|144355579|SUPERIORITY|||||||0.7443|||||||t-test, 2 sided|||||||0.7443
72422389|NCT00560612|144355580|SUPERIORITY|||||||0.065|||||||t-test, 2 sided|||||||0.065
72330913|NCT02388165|144188180|SUPERIORITY||Difference in percentage of participants|3.0|||||TWO_SIDED|95.0|1.9|4.2||||||Pain at the injection site: Moderate||4.2|1.9|
72422390|NCT01060553|144355581|SUPERIORITY_OR_OTHER|||||||0.15|TWO_SIDED||||||t-test, 2 sided|||for mcs||||.15
72422391|NCT01060553|144355581|SUPERIORITY_OR_OTHER|||||||0.28|TWO_SIDED||||||t-test, 2 sided|||for pcs||||.28
72330914|NCT02388165|144188180|SUPERIORITY||Difference in percentage of participants|0.5|||||TWO_SIDED|95.0|0.1|1.0||||||Pain at the injection site: Severe||1.0|0.1|
72422392|NCT01060553|144355582|SUPERIORITY_OR_OTHER|||||||0.34|TWO_SIDED||||||t-test, 2 sided|||for sleep duration||||.34
72422393|NCT01060553|144355582|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED||||||t-test, 2 sided|||for sleep disturbance||||.001
72422394|NCT01060553|144355582|SUPERIORITY_OR_OTHER|||||||0.015|TWO_SIDED||||||t-test, 2 sided|||for sleep latency||||.015
72422395|NCT04037436|144355598|OTHER|GEE|GEE|1.65||||0.05|TWO_SIDED|95.0|-4.44|7.73|||GEE|To model the interaction between exposure to the MoveStrong program and site on secondary outcomes we applied a generalized estimating equation (GEE).||To model the interaction between exposure to the MoveStrong program and site on secondary outcomes we applied a generalized estimating equation (GEE).||7.73|-4.44|0.05
72422396|NCT00332332|144355675|SUPERIORITY_OR_OTHER||Percentage of participants|73.5||||||95.0|67.2|79.1||||||||79.1|67.2|
72422397|NCT02790073|144355685|OTHER|Within group comparison vs baseline|||||<|0.001|TWO_SIDED|95.0|||||t-test, 2 sided|||||||<0.001
72422398|NCT02790073|144355686|OTHER|Within group comparison vs baseline||||||0.015|TWO_SIDED|95.0|||||t-test, 2 sided|||||||0.015
72422399|NCT02790073|144355687|OTHER|Within group comparison vs baseline||||||0.003|TWO_SIDED|95.0|||||t-test, 2 sided|||||||0.003
72422400|NCT02243202|144355704|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-3.5|STANDARD_ERROR_OF_MEAN|0.9|<|0.001|TWO_SIDED|95.0|-5.3|-1.8|||Mixed Model for Repeated Measures|||||-1.8|-5.3|<0.001
72422401|NCT02243202|144355704|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-1.3|STANDARD_ERROR_OF_MEAN|0.9||0.142|TWO_SIDED|95.0|-3.1|0.4|||Mixed Model for Repeated Measures|||||0.4|-3.1|0.142
72422402|NCT02243202|144355704|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-6.9|STANDARD_ERROR_OF_MEAN|0.9|<|0.001|TWO_SIDED|95.0|-8.6|-5.2|||Mixed Model for Repeated Measures|||||-5.2|-8.6|<0.001
72422403|NCT02243202|144355705|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.15||||0.002|TWO_SIDED|95.0|1.7|10.14|||Generalized linear Mixed Model|||||10.14|1.70|0.002
72422404|NCT02243202|144355705|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.12||||0.825|TWO_SIDED|95.0|0.41|3.06|||Generalized linear Mixed Model|||||3.06|0.41|0.825
72422405|NCT02243202|144355705|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|10.2|||<|0.001|TWO_SIDED|95.0|4.15|25.05|||Generalized linear Mixed Model|||||25.05|4.15|<0.001
72422406|NCT02243202|144355706|SUPERIORITY_OR_OTHER||Least Square Mean Difference|1.3|STANDARD_ERROR_OF_MEAN|1.8||0.456|TWO_SIDED|95.0|-2.1|4.8|||Mixed Model for Repeated Measures|||||4.8|-2.1|0.456
72422407|NCT02243202|144355706|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|1.8||0.827|TWO_SIDED|95.0|-3.9|3.1|||Mixed Model for Repeated Measures|||||3.1|-3.9|0.827
72422408|NCT02243202|144355706|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-4.2|STANDARD_ERROR_OF_MEAN|1.7||0.015|TWO_SIDED|95.0|-7.7|-0.8|||Mixed Model for Repeated Measures|||||-0.8|-7.7|0.015
72422409|NCT02243202|144355707|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-3.5|STANDARD_ERROR_OF_MEAN|0.9|<|0.001|TWO_SIDED|95.0|-5.3|-1.7|||Mixed Model for Repeated Measures|||||-1.7|-5.3|<0.001
72422410|NCT02243202|144355707|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-1.3|STANDARD_ERROR_OF_MEAN|0.9||0.153|TWO_SIDED|95.0|-3.1|0.5|||Mixed Model for Repeated Measures|||||0.5|-3.1|0.153
72330915|NCT02388165|144188181|SUPERIORITY||Difference in percentage of participants|0.6||||0.146|TWO_SIDED|95.0|-0.2|1.6|||Miettinen and Nurminen|||Fever: Any||1.6|-0.2|0.146
72422411|NCT02243202|144355707|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-6.7|STANDARD_ERROR_OF_MEAN|0.9|<|0.001||95.0|-8.5|-4.9|||Mixed Model for Repeated Measures|||||-4.9|-8.5|<0.001
72422412|NCT03243422|144355718|SUPERIORITY||change in Standard Deviation|0.002||||0.96|TWO_SIDED|95.0|-0.077|0.081|||Mixed Models Analysis|Three-level linear mixed effects model with an unstructured covariance matrix from the baseline and the year 3 in-person neurocognitive assessment||||0.081|-0.077|0.96
72422413|NCT03243422|144355719|SUPERIORITY||Slope|0.079||||0.15|TWO_SIDED|95.0|-0.029|0.187||Secondary outcomes were evaluated with Hochberg modification to the Bonferroni adjustment estimates are considered statistically significant if the largest p-value is \<0·05.|Mixed Models Analysis|||||0.187|-0.029|0.15
72422414|NCT03243422|144355720|SUPERIORITY||Slope|-0.02||||0.69|TWO_SIDED|95.0|-0.118|0.078||Secondary outcomes were evaluated with Hochberg modification to the Bonferroni adjustment estimates are considered statistically significant if the largest p-value is \<0·05.|Mixed Models Analysis|||||0.078|-0.118|0.69
72422415|NCT03243422|144355721|SUPERIORITY||Slope|0.017||||0.7|TWO_SIDED|95.0|-0.07|0.104||Secondary outcomes were evaluated with Hochberg modification to the Bonferroni adjustment estimates are considered statistically significant if the largest p-value is \<0·05.|Mixed Models Analysis|||||0.104|-0.070|0.70
72422416|NCT03243422|144355722|SUPERIORITY||Hazard Ratio (HR)|0.9||||0.59|TWO_SIDED|95.0|0.61|1.33||Secondary outcomes were evaluated with Hochberg modification to the Bonferroni adjustment estimates are considered statistically significant if the largest p-value is \<0·05.|Regression, Cox|Discrete-time interval model||||1.33|0.61|0.59
72422417|NCT03243422|144355723|SUPERIORITY||Slope|0.191||||0.027|TWO_SIDED|95.0|0.022|0.36|||Mixed Models Analysis|||Analysis was restricted to ARIC participants who were enrolled in ACHIEVE||0.360|0.022|0.027
72422418|NCT03243422|144355724|SUPERIORITY||Slope|-0.061||||0.18|TWO_SIDED|95.0|-0.151|0.028|||Mixed Models Analysis|||||0.028|-0.151|0.18
72422419|NCT02173054|144355738|SUPERIORITY_OR_OTHER|||||||0.001||||||This statistical analysis was used to compare number of participants who had erythema among 3 groups.|Kruskal-Wallis|||||||0.001
72422420|NCT02173054|144355738|SUPERIORITY_OR_OTHER|||||||0.016||||||This statistical analysis was used to compare number of participants who had dryness among 3 groups|Kruskal-Wallis|||||||0.016
72422421|NCT02173054|144355738|SUPERIORITY_OR_OTHER|||||||0.025||||||This statistical analysis was used to compare number of participants who had scaling among 3 groups.|Kruskal-Wallis|||||||0.025
72422422|NCT02173054|144355738|SUPERIORITY_OR_OTHER|||||||0.571||||||This statistical analysis was used to compare number of participants who had stinging among 3 groups.|Kruskal-Wallis|||||||0.571
72422423|NCT02173054|144355738|SUPERIORITY_OR_OTHER|||||||0.449||||||This statistical analysis was used to compare number of participants who had pruritus among 3 groups.|Kruskal-Wallis|||||||0.449
72422424|NCT02173054|144355739|SUPERIORITY_OR_OTHER|||||||0.059||||||This statistical analysis was used to evaluate the change in total lesion counts at baseline and 8th week|wilcoxan signed ranks test|||||||0.059
72422425|NCT02173054|144355739|SUPERIORITY_OR_OTHER|||||||0.697||||||This statistical analysis was used to evaluate the change in total lesion counts at baseline and 8th week|wilcoxan signed ranks test|||||||0.697
72422426|NCT02173054|144355739|SUPERIORITY_OR_OTHER|||||||0.028||||||This statistical analysis was used to evaluate the change in total lesion counts at baseline and 8th week.|wilcoxan signed ranks test|||||||0.028
72330916|NCT02388165|144188181|SUPERIORITY||Difference in percentage of participants|0.4|||||TWO_SIDED|95.0|-0.3|1.2||||||Fever: 38.0 degree C to 38.4 degree C||1.2|-0.3|
72422427|NCT02173054|144355739|SUPERIORITY_OR_OTHER|||||||0.001||||||This statistical analysis was used to evaluate the change in inflammatory lesion counts at baseline and 8th week.|wilcoxan signed ranks test|||||||0.001
72422428|NCT02173054|144355739|SUPERIORITY_OR_OTHER|||||||0.755||||||This statistical analysis was used to evaluate the change in inflammatory lesion counts at baseline and 8th week.|wilcoxan signed ranks test|||||||0.755
72422429|NCT02173054|144355739|SUPERIORITY_OR_OTHER|||||||0.003||||||This statistical analysis was used to evaluate the change in inflammatory lesion counts at baseline and 8th week.|wilcoxan signed ranks test|||||||0.003
72422430|NCT02173054|144355739|SUPERIORITY_OR_OTHER|||||||0.205||||||This statistical analysis was used to evaluate the change in non inflammatory lesion counts at baseline and 8th week.|wilcoxan signed ranks test|||||||0.205
72422431|NCT02173054|144355739|SUPERIORITY_OR_OTHER|||||||0.576||||||This statistical analysis was used to evaluate the change in non inflammatory lesion counts at baseline and 8th week.|wilcoxan signed ranks test|||||||0.576
72422432|NCT02173054|144355739|SUPERIORITY_OR_OTHER|||||||0.16||||||This statistical analysis was used to evaluate the change in non inflammatory lesion counts at baseline and 8th week.|wilcoxan signed ranks test|||||||0.160
72422433|NCT02173054|144355740|SUPERIORITY_OR_OTHER|||||||0.078||||||This statistical analysis was used to evaluate the change in skin sebum content at baseline and 8th week of the Adapalene gel group|Paired t-test|||||||0.078
72422434|NCT02173054|144355740|SUPERIORITY_OR_OTHER|||||||0.167||||||This statistical analysis was used to evaluate the change in skin sebum content at baseline and 8th week of the Adapalene gel with placebo moisturizer group|Paired t-test|||||||0.167
72422435|NCT02173054|144355740|SUPERIORITY_OR_OTHER|||||||0.134||||||This statistical analysis was used to evaluate the change in skin sebum content at baseline and 8th week of the Adapalene gel with Eucerin group|Paired t-test|||||||0.134
72422436|NCT02173054|144355740|SUPERIORITY_OR_OTHER|||||||0.978||||||This statistical analysis was used to evaluate the change in skin hydration at baseline and 8th week of the Adapalene gel group|Paired t-test|||||||0.978
72422437|NCT02173054|144355740|SUPERIORITY_OR_OTHER|||||||0.273||||||This statistical analysis was used to evaluate the change in skin hydration at baseline and 8th week of the Adapalene gel with placebo moisturizer group|Paired t-test|||||||0.273
72422438|NCT02173054|144355740|SUPERIORITY_OR_OTHER|||||||0.735||||||This statistical analysis was used to evaluate the change in skin hydration at baseline and 8th week of the Adapalene gel with Eucerin group.|Paired t-test|||||||0.735
72422439|NCT02173054|144355741|SUPERIORITY_OR_OTHER|||||||0.0002||||||This statistical analysis was used to evaluate the change in TEWL at baseline and 8th week of the Adapalene gel group.|Paired t-test|||||||0.0002
72422440|NCT02173054|144355741|SUPERIORITY_OR_OTHER|||||||0.007||||||This statistical analysis was used to evaluate the change in TEWL at baseline and 8th week of the Adapalene gel with placebo moisturizer group.|Paired t-test|||||||0.007
72330917|NCT02388165|144188181|SUPERIORITY||Difference in percentage of participants|0.1|||||TWO_SIDED|95.0|-0.4|0.6||||||Fever: 38.5 degree C to 38.9 degree C||0.6|-0.4|
72422441|NCT02173054|144355741|SUPERIORITY_OR_OTHER|||||||0.123||||||This statistical analysis was used to evaluate the change in TEWL at baseline and 8th week of the Adapalene gel with Eucerin group.|Paired t-test|||||||0.123
72422442|NCT02173054|144355742|SUPERIORITY_OR_OTHER|||||||0.005||||||This statistical analysis was used to evaluate the change in ASI score at baseline and 8th week.|wilcoxan signed ranks test|||||||0.005
72422443|NCT02173054|144355742|SUPERIORITY_OR_OTHER|||||||0.606||||||This statistical analysis was used to evaluate the change in ASI score at baseline and 8th week.|wilcoxan signed ranks test|||||||0.606
72422444|NCT02173054|144355742|SUPERIORITY_OR_OTHER|||||||0.001||||||This statistical analysis was used to evaluate the change in ASI score at baseline and 8th week.|wilcoxan signed ranks test|||||||0.001
72422445|NCT02401464|144355744|NON_INFERIORITY_OR_EQUIVALENCE|Formulations were considered bioequivalent if: 1) 90% Cls of the differences in the means of the natural log-transformed AUC(0-48) and Cmax between commercial and pediatric formulations was within ln(0.80)- ln(1.25);2) Differences in the means of the natural log-transformed AUC(0-48) and Cmax between commercial and pediatric formulations was within ln(0.9)-ln(1.11),and results of the dissolution test met the conditions specified in the Guideline for Bioequivalence Studies of Generic Products.|Least Squares (LS) mean difference (ln)|0.963|||||TWO_SIDED|90.0|0.927|1.001||||||Based on the analysis of variance (ANOVA) in which the natural logarithms of AUC(0-48) of TAK-536 were used as dependent variables, and formulation, sequence (administration order) and administration period were used as fixed effects, bioequivalence was assessed providing two-sided 90% confidence intervals (CIs) for the differences between the formulations and between the periods.||1.001|0.927|
72330918|NCT02388165|144188181|SUPERIORITY||Difference in percentage of participants|0.1|||||TWO_SIDED|95.0|-0.2|0.5||||||Fever: 39.0 degree C to 40.0 degree C||0.5|-0.2|
72330919|NCT02388165|144188181|SUPERIORITY||Difference in percentage of participants|0.1|||||TWO_SIDED|95.0|-0.2|0.3||||||Fever: \>40.0 degree C||0.3|-0.2|
72330920|NCT02388165|144188181|SUPERIORITY||Difference in percentage of participants|2.9||||0.093||95.0|-0.5|6.2|||Miettinen and Nurminen|||Fatigue: Any||6.2|-0.5|0.093
72330921|NCT02388165|144188181|SUPERIORITY||Difference in percentage of participants|1.4|||||TWO_SIDED|95.0|-0.9|3.7||||||Fatigue: Mild||3.7|-0.9|
72330922|NCT02388165|144188181|SUPERIORITY||Difference in percentage of participants|1.3|||||TWO_SIDED|95.0|-1.6|4.2||||||Fatigue: Moderate||4.2|-1.6|
72330923|NCT02388165|144188181|SUPERIORITY||Difference in percentage of participants|0.2|||||TWO_SIDED|95.0|-1.2|1.6||||||Fatigue: Severe||1.6|-1.2|
72330924|NCT02388165|144188181|SUPERIORITY||Difference in percentage of participants|1.2||||0.443|TWO_SIDED|95.0|-1.9|4.4|||Miettinen and Nurminen|||Headache: Any||4.4|-1.9|0.443
72330925|NCT02388165|144188181|SUPERIORITY||Difference in percentage of participants|-0.3|||||TWO_SIDED|95.0|-2.9|2.3||||||Headache: Mild||2.3|-2.9|
72330926|NCT02388165|144188181|SUPERIORITY||Difference in percentage of participants|1.5|||||TWO_SIDED|95.0|-0.7|3.8||||||Headache: Moderate||3.8|-0.7|
72330927|NCT02388165|144188181|SUPERIORITY||Difference in percentage of participants|0.0|||||TWO_SIDED|95.0|-0.8|0.8||||||Headache: Severe||0.8|-0.8|
72330928|NCT02388165|144188181|SUPERIORITY||Difference in percentage of participants|1.0||||0.462|TWO_SIDED|95.0|-1.6|3.4|||Miettinen and Nurminen|||Diarrhea: Any||3.4|-1.6|0.462
72330929|NCT02388165|144188181|SUPERIORITY||Difference in percentage of participants|0.8|||||TWO_SIDED|95.0|-1.5|3.0||||||Diarrhea: Mild||3.0|-1.5|
72330930|NCT02388165|144188181|SUPERIORITY||Difference in percentage of participants|0.5||||||95.0|-0.7|1.7||||||Diarrhea: Moderate||1.7|-0.7|
72330931|NCT02388165|144188181|SUPERIORITY||Difference in percentage of participants|-0.4|||||TWO_SIDED|95.0|-1.0|0.2||||||Diarrhea: Severe||0.2|-1.0|
72330932|NCT02388165|144188181|SUPERIORITY||Difference in percentage of participants|-0.6||||0.3||95.0|-1.8|0.5|||Miettinen and Nurminen|||Vomiting: Any||0.5|-1.8|0.300
72330933|NCT02388165|144188181|SUPERIORITY||Difference in percentage of participants|-0.2|||||TWO_SIDED|95.0|-1.3|0.8||||||Vomiting: Mild||0.8|-1.3|
72553871|NCT05342597|144639789|OTHER|Estimated difference in least squares means and corresponding 90%CI of log-transformed PK parameters were back transformed to obtain the estimate and CI of the geometric mean ratio of each meal condition to the fasted state.|LS Mean Ratio|0.82|||||TWO_SIDED|90.0|0.621|1.082|||ANOVA|||PK parameters of unchanged edaravone were analyzed for the assessments of food effect on PK.||1.082|0.621|
72330934|NCT02388165|144188181|SUPERIORITY||Difference in percentage of participants|-0.4||||||95.0|-0.9|0.1||||||Vomiting: Moderate||0.1|-0.9|
72330935|NCT02388165|144188181|SUPERIORITY||Difference in percentage of participants|1.7||||0.276||95.0|-1.3|4.7|||Miettinen and Nurminen|||Muscle pain: Any||4.7|-1.3|0.276
72330936|NCT02388165|144188181|SUPERIORITY||Difference in percentage of participants|0.8|||||TWO_SIDED|95.0|-1.2|2.8||||||Muscle pain: Mild||2.8|-1.2|
72330937|NCT02388165|144188181|SUPERIORITY||Difference in percentage of participants|1.1|||||TWO_SIDED|95.0|-1.4|3.5||||||Muscle pain: Moderate||3.5|-1.4|
72330938|NCT02388165|144188181|SUPERIORITY||Difference in percentage of participants|-0.2||||||95.0|-1.2|0.8||||||Muscle pain: Severe||0.8|-1.2|
72330939|NCT02388165|144188181|SUPERIORITY||Difference in percentage of participants|1.7||||0.273|TWO_SIDED|95.0|-1.3|4.6|||Miettinen and Nurminen|||Joint pain: Any||4.6|-1.3|0.273
72330940|NCT02388165|144188181|SUPERIORITY||Difference in percentage of participants|1.6|||||TWO_SIDED|95.0|-0.2|3.6||||||Joint pain: Mild||3.6|-0.2|
72330941|NCT02388165|144188181|SUPERIORITY||Difference in percentage of participants|0.0|||||TWO_SIDED|95.0|-2.6|2.4||||||Joint pain: Moderate||2.4|-2.6|
72330942|NCT02388165|144188181|SUPERIORITY||Difference in percentage of participants|0.1||||||95.0|-0.9|1.0||||||Joint pain: Severe||1.0|-0.9|
72330943|NCT02388165|144188189|SUPERIORITY||VE|0.0|||||TWO_SIDED|95.0|-126.3|55.81|||||VE was calculated as 1-(P/\[1-P\]\*100), where P is the number of SA4Ag cases divided by the total number of cases. The CI was calculated using the Clopper-Pearson method.|||55.81|-126.30|
72330944|NCT02388165|144188190|SUPERIORITY||VE|-9.09|||||TWO_SIDED|95.0|-104.06|41.41|||||VE was calculated as 1-(P/\[1-P\]\*100), where P is the number of SA4Ag cases divided by the total number of cases. The CI was calculated using the Clopper-Pearson method.|||41.41|-104.06|
72330945|NCT02388165|144188191|SUPERIORITY||VE|-8.7|||||TWO_SIDED|95.0|-100.42|40.8|||||VE was calculated as 1-(P/\[1-P\]\*100), where P is the number of SA4Ag cases divided by the total number of cases. The CI was calculated using the Clopper-Pearson method.|||40.80|-100.42|
72330946|NCT03215758|144188244|SUPERIORITY||Mean Difference (Net)|0.0238||||0.088|TWO_SIDED|95.0|-0.006|0.088|||ANCOVA|||||0.088|-0.006|0.088
72330947|NCT03215758|144188245|SUPERIORITY||Mean Difference (Net)|-0.06||||0.278|TWO_SIDED|95.0|-0.16|0.05|||ANCOVA|||||0.05|-0.16|0.278
72330948|NCT03215758|144188246|SUPERIORITY||Mean Difference (Net)|-0.08||||0.429|TWO_SIDED|95.0|-0.3|0.13|||ANCOVA|||||0.13|-0.30|0.429
72330949|NCT03215758|144188247|SUPERIORITY||Mean Difference (Net)|0.069||||0.777|TWO_SIDED|95.0|-0.12|0.15|||ANCOVA|||||0.15|-0.12|0.777
72330950|NCT01942668|144188248|SUPERIORITY||Mean Difference (Final Values)|-12.81|STANDARD_ERROR_OF_MEAN|3.3|<|0.001|TWO_SIDED|95.0|-19.29|-6.32||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 4|Mixed Models Analysis|Each co-primary endpt in each dose group tested at alpha=0.05;multiple dose groups vs. PBO comparisons are conducted using gatekeeping procedure|Adjusted for baseline using MMRM|||-6.32|-19.29|<0.001
72422446|NCT02401464|144355745|NON_INFERIORITY_OR_EQUIVALENCE|Formulations were considered bioequivalent if: 1)90% Cls of the differences in the means of the natural log-transformed AUC(0-48) and Cmax between commercial and pediatric formulations was within ln(0.80)- ln(1.25);2) Differences in the means of the natural log-transformed AUC(0-48) and Cmax between commercial and pediatric formulations was within ln(0.9)-ln(1.11),and results of the dissolution test met the conditions specified in the Guideline for Bioequivalence Studies of Generic Products.|LS mean difference (ln)|0.906|||||TWO_SIDED|90.0|0.88|0.933||||||Based on the ANOVA in which the natural logarithms of Cmax of TAK-536 were used as dependent variables, and formulation, sequence (administration order) and administration period were used as fixed effects, bioequivalence was assessed providing two-sided 90% CIs for the differences between the formulations and between the periods.||0.933|0.880|
72422447|NCT02401464|144355746|NON_INFERIORITY_OR_EQUIVALENCE|Formulations were considered bioequivalent if: 1) 90% Cls of the differences in the means of the natural log-transformed AUC(0-48) and Cmax between commercial and pediatric formulations was within ln(0.80)- ln(1.25);2) Differences in the means of the natural log-transformed AUC(0-48) and Cmax between commercial and pediatric formulations was within ln(0.9)-ln(1.11),and results of the dissolution test met the conditions specified in the Guideline for Bioequivalence Studies of Generic Products.|LS mean difference (ln)|0.985|||||TWO_SIDED|90.0|0.958|1.011||||||Based on the ANOVA in which the natural logarithms of AUC(0-48) of TAK-536 were used as dependent variables, and formulation, sequence (administration order) and administration period were used as fixed effects, bioequivalence was assessed providing two-sided 90% CIs for the differences between the formulations and between the periods.||1.011|0.958|
72422448|NCT02401464|144355747|NON_INFERIORITY_OR_EQUIVALENCE|Formulations were considered bioequivalent if: 1) 90% Cls of the differences in the means of the natural log-transformed AUC(0-48) and Cmax between commercial and pediatric formulations was within ln(0.80)- ln(1.25);2) Differences in the means of the natural log-transformed AUC(0-48) and Cmax between commercial and pediatric formulations was within ln(0.9)-ln(1.11),and results of the dissolution test met the conditions specified in the Guideline for Bioequivalence Studies of Generic Products.|LS mean difference (ln)|0.979|||||TWO_SIDED|90.0|0.938|1.022||||||Based on the ANOVA in which the natural logarithms of Cmax of TAK-536 were used as dependent variables, and formulation, sequence (administration order) and administration period were used as fixed effects, bioequivalence was assessed providing two-sided 90% CIs for the differences between the formulations and between the periods.||1.022|0.938|
72422449|NCT00615264|144355794|SUPERIORITY_OR_OTHER|||||||0.2851|||||||Mixed Models Analysis|Calculated with terms for treatment, visit, treatment by visit interaction, baseline C-peptide and country with the unstructured option for the matrix||||||0.2851
72422450|NCT00615264|144355795|SUPERIORITY_OR_OTHER|||||||0.769|||||||Mixed Models Analysis|Calculated with terms for treatment, visit, treatment by visit interaction, baseline C-peptide and country with the unstructured option for the matrix||||||0.7690
72422451|NCT01187914|144355796|SUPERIORITY_OR_OTHER||Regression coefficient|0.13||||0.48||95.0|||||Regression, Linear|||||||0.48
72422452|NCT03802864|144355891|SUPERIORITY|||||||0.41|||||||t-test, 2 sided|||||||0.41
72422453|NCT03802864|144355892|SUPERIORITY|||||||0.37|||||||t-test, 2 sided|||||||0.37
72422454|NCT03802864|144355893|SUPERIORITY|||||||0.36|||||||t-test, 2 sided|||||||0.36
72422455|NCT03802864|144355894|SUPERIORITY|||||||0.28|||||||Regression, Linear|||||||0.28
72422456|NCT03802864|144355895|SUPERIORITY|||||||0.78|||||||Log Rank|||||||0.78
72422457|NCT03802864|144355896|SUPERIORITY|||||||0.49|||||||Fisher Exact|||||||0.49
72422458|NCT03802864|144355897|SUPERIORITY|||||||0.99|||||||Fisher Exact|||||||0.99
72422459|NCT00708435|144355910|NON_INFERIORITY_OR_EQUIVALENCE|"The non-inferiority margin was -(minus)10%. If the lower limit of the 2-sided 95% CI was \>-10%, then the null-hypothesis was rejected and it was concluded that Beriplex was non-inferior to plasma.~The sample size estimation assumed that hemostatic efficacy would be rated 'effective' in 85% of participants in the plasma group and 90% of participants in the Beriplex group. The power to show non-inferiority with these assumptions was greater than 80% for two treatment groups of 83 participants."|Difference in effective hemostasis (%)|7.1|||||TWO_SIDED|95.0|-5.8|19.9||Both primary endpoints had to be non-inferior for Beriplex to be non-inferior. No P-value is entered as non-inferiority was assessed via the 95% CI calculation for the difference (Beriplex minus plasma) in the % of subjects with effective hemostasis.|95% confidence interval|Farrington and Manning's method was used to estimate the 95% CI for the difference in the percentage of participants with hemostasis.|Both primary endpoints had to be non-inferior for Beriplex to be non-inferior. There is no P-value as non-inferiority was assessed via the 95% CI calculation for the difference (Beriplex minus plasma) in the % of subjects with effective hemostasis.|The analysis of hemostatic efficacy was via calculation of the 95% confidence interval (CI) for the difference (Beriplex minus plasma) in the percentage of participants with effective hemostasis.||19.9|-5.8|
72553872|NCT05342597|144639789|OTHER|Estimated difference in least squares means and corresponding 90%CI of log-transformed PK parameters were back transformed to obtain the estimate and CI of the geometric mean ratio of each meal condition to the fasted state.|LS Mean Ratio|0.536|||||TWO_SIDED|90.0|0.362|0.794|||ANOVA|||PK parameters of unchanged edaravone were analyzed for the assessments of food effect on PK.||0.794|0.362|
72553873|NCT00968812|144639818|NON_INFERIORITY_OR_EQUIVALENCE|Power calculation: assuming a difference between canagliflozin and glimepiride of 0.0% and a common standard deviation of 1.0%, and using a 2-sample, 1-sided t-test with a Type I error rate of 0.0125, and assuming a drop-out rate of 35% in 52 weeks, it was estimated that approximately 427 patients per group would provide 90% power to demonstrate non-inferiority with the non-inferiority margin of 0.3, comparing canagliflozin with glimepiride.|Least-Squares Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.05|||TWO_SIDED|95.0|-0.109|0.085|||ANCOVA|||If the hypothesis of non-inferiority of canagliflozin to glimepiride at Week 52 was demonstrated (ie, upper bound of the 95% Confidence Interval of the treatment difference \[canagliflozin minus glimepiride\] was less than 0.3) and the upper bound was less than 0.0, the superiority of the canagliflozin dose relative to glimepiride would be concluded.||0.085|-0.109|
72553901|NCT00571064|144639896|SUPERIORITY_OR_OTHER|||||||0.4724|TWO_SIDED|||||Significance level of 0.05|t-test, 2 sided|||Week 12 LOCF - Study Endpoint||||0.4724
72553902|NCT05615935|144639904|SUPERIORITY||Adjusted Mean Difference (ANCOVA)|2.07|||<|0.001|TWO_SIDED|||||The p-value is adjusted for multiple comparisons using the Bonferroni correction, with a significance threshold of 0.05.|ANCOVA|||Using G\*Power 3.1, the required sample size for ANCOVA with two groups was estimated with a significance level of 0.05, statistical power of 0.80, and an effect size of 0.35, based on Cohen's guidelines for a medium-to-large effect commonly applied in behavioral research (Cohen, 1988). Assuming up to two covariates, a minimum of 67 participants was required. Accounting for a 10% attrition rate, the final target was set at 74 participants.||||<0.001
72553903|NCT05615935|144639905|SUPERIORITY||Adjusted Mean Difference (ANCOVA)|4.58||||0.15|TWO_SIDED|||||The p-value is adjusted for multiple comparisons using the Bonferroni correction, with a significance threshold of 0.05.|ANCOVA|||||||0.15
72330951|NCT01942668|144188248|SUPERIORITY||Mean Difference (Final Values)|-8.07|STANDARD_ERROR_OF_MEAN|3.25||0.013|TWO_SIDED|95.0|-14.46|-1.68||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 4|Mixed Models Analysis|Each co-primary endpt in each dose group tested at alpha=0.05;multiple dose groups vs. PBO comparisons are conducted using gatekeeping procedure|Adjusted for baseline using MMRM|||-1.68|-14.46|0.013
72330952|NCT01942668|144188248|SUPERIORITY||Mean Difference (Final Values)|-4.81|STANDARD_ERROR_OF_MEAN|3.26||0.141|TWO_SIDED|95.0|-11.21|1.59||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 4|Mixed Models Analysis|Each co-primary endpt in each dose group tested at alpha=0.05;multiple dose groups vs. PBO comparisons are conducted using gatekeeping procedure|Adjusted for baseline using MMRM|||1.59|-11.21|0.141
72330953|NCT01942668|144188248|SUPERIORITY||Mean Difference (Final Values)|-10.4|STANDARD_ERROR_OF_MEAN|3.22||0.001|TWO_SIDED|95.0|-16.73|-4.08||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 4|Mixed Models Analysis|Each co-primary endpt in each dose group tested at alpha=0.05;multiple dose groups vs. PBO comparisons are conducted using gatekeeping procedure|Adjusted for baseline using MMRM|||-4.08|-16.73|0.001
72422460|NCT00708435|144355911|NON_INFERIORITY_OR_EQUIVALENCE|"The non-inferiority margin was -(minus)10%. If the lower limit of the 2-sided 95% CI was \>-10%, then the null-hypothesis was rejected and it was concluded that Beriplex was non-inferior to plasma.~The sample size estimation assumed that hemostatic efficacy would be rated 'effective' in 85% of participants in the plasma group and 90% of participants in the Beriplex group. The power to show non-inferiority with these assumptions was greater than 80% for two treatment groups of 83 participants."|Difference in the decrease of INR (%)|52.6|||||TWO_SIDED|95.0|39.4|65.9||Both primary endpoints had to be non-inferior for Beriplex to be non-inferior. No P-value is entered as non-inferiority was assessed via the 95% CI for the difference (Beriplex minus plasma) in the % of subjects with a rapid decrease of the INR.|95% confidence interval|Farrington and Manning's method was used to estimate the 95% CI for the difference in the percentage of participants with a rapid decrease of the INR.|Both primary endpoints had to be non-inferior for Beriplex to be non-inferior. There is no P-value as non-inferiority was assessed via the 95% CI for the difference (Beriplex minus plasma) in the % of subjects with a rapid decrease of the INR.|The analysis of the percentage of participants who had a rapid decrease of the INR was via calculation of the 95% confidence interval (CI) for the difference (Beriplex minus plasma) in the percentage of participants with a rapid decrease of the INR.||65.9|39.4|
72422461|NCT01498822|144355944|NON_INFERIORITY_OR_EQUIVALENCE|The primary analysis of this study aimed to demonstrate that LEV was noninferior to OXC with respect to the treatment failure rate in the Per Protocol Set. The noninferiority margin was 15 %.|Absolut difference|-10.7|||||TWO_SIDED|95.0|-20.2|-1.2|||Wald methodology||"Absolute difference in treatment failure rates of LEV versus OXC is defined as Treatment Failure Rate LEV minus Treatment Failure Rate OXC."|||-1.2|-20.2|
72422462|NCT03131960|144355968|SUPERIORITY|||||||0.0014|||||||ANCOVA|||||||0.0014
72422463|NCT03131960|144355969|SUPERIORITY|||||||0.0077|||||||ANCOVA|||ANCOVA||||0.0077
72422464|NCT03131960|144355970|SUPERIORITY|||||||0.0098|||||||Regression, Logistic|||||||0.0098
72422465|NCT03131960|144355971|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
72422466|NCT02481375|144355972|OTHER||Marginal means|0.0|||<|0.05|TWO_SIDED|95.0|||||Regression, Linear|||Marginal means (95% CI) of ferritin concentrations at 12-weeks using a generalized mixed-effects model with adjustments for baseline values and village clusters||||<0.05
72422467|NCT01674621|144355973|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0066||||||Threshold for significance at 0.05 level.|Dunnett's test|P-value from Dunnett's test comparing percent change of BMD from baseline to end-of-treatment to each transdermal dose group versus placebo.||||||0.0066
72422468|NCT01674621|144355973|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0005||||||Threshold for significance at 0.05 level.|Dunnett's test|P-value from Dunnett's test comparing percent change of BMD from baseline to end-of-treatment to each transdermal dose group versus placebo.||||||0.0005
72422469|NCT01674621|144355973|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Threshold for significance at 0.05 level.|Dunnett's test|P-value from Dunnett's test comparing percent change of BMD from baseline to end-of-treatment to each transdermal dose group versus placebo.||||||<0.0001
72422470|NCT01674621|144355973|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.93|||||TWO_SIDED|95.0|-5.555|-2.305|||||Mean difference of percent change of BMD from baseline to end-of-treatment between treatment groups (transdermal and SC injection).|||-2.305|-5.555|
72422471|NCT01674621|144355973|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.47|||||TWO_SIDED|95.0|-5.104|-1.837|||||Mean difference of percent change of BMD from baseline to end-of-treatment between treatment groups (transdermal and SC injection).|||-1.837|-5.104|
72422472|NCT01674621|144355973|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.856|||||TWO_SIDED|95.0|-4.519|-1.193|||||Mean difference of percent change of BMD from baseline to end-of-treatment between treatment groups (transdermal and SC injection).|||-1.193|-4.519|
72422473|NCT01674621|144355974|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0547||||||Threshold for significance at 0.05 level.|Dunnett's test|P-value from Dunnett's test comparing percent change of BMD from baseline to end-of-treatment to each transdermal dose group versus placebo.||||||0.0547
72422474|NCT01674621|144355974|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0056||||||Threshold for significance at 0.05 level.|Dunnett's test|P-value from Dunnett's test comparing percent change of BMD from baseline to end-of-treatment to each transdermal dose group versus placebo.||||||0.0056
72422475|NCT01674621|144355974|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0018||||||Threshold for significance at 0.05 level.|Dunnett's test|P-value from Dunnett's test comparing percent change of BMD from baseline to end-of-treatment to each transdermal dose group versus placebo.||||||0.0018
72422476|NCT01674621|144355974|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.768|||||TWO_SIDED|95.0|-2.864|-0.672|||||Mean difference of percent change off BMD from baseline to end-of-treatment between active treatment groups (transdermal and SC injection).|||-0.672|-2.864|
72422477|NCT01674621|144355974|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.42|||||TWO_SIDED|95.0|-2.522|-0.318|||||Mean difference of percent change of BMD from baseline to end-of-treatment between treatment groups (transdermal and SC injection).|||-0.318|-2.522|
72422478|NCT01674621|144355974|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.247|||||TWO_SIDED|95.0|-2.368|-0.126|||||Mean difference of percent change of BMD from baseline to end-of-treatment between treatment groups (transdermal and SC injection).|||-0.126|-2.368|
72422479|NCT01674621|144355975|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9493||||||Threshold for significance at 0.05 level.|Dunnett's test|P-value from Dunnett's test comparing percent change of BMD from baseline to end-of treatment to each transdermal dose group versus placebo.||||||0.9493
72422480|NCT01674621|144355975|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9806||||||Threshold for significance at 0.05 level.|Dunnett's test|P-value from Dunnett's test comparing percent change of BMD from baseline to end-of treatment to each transdermal dose group versus placebo.||||||0.9806
72422481|NCT01674621|144355975|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5191||||||Threshold for significance at 0.05 level.|Dunnett's test|P-value from Dunnett's test comparing percent change of BMD from baseline to end-of treatment to each transdermal dose group versus placebo.||||||0.5191
72422482|NCT01674621|144355975|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.564|||||TWO_SIDED|95.0|-2.168|1.04|||||Mean difference of percent change off BMD from baseline to end-of-treatment between active treatment groups (transdermal and SC injection).|||1.040|-2.168|
72422483|NCT01674621|144355975|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.483|||||TWO_SIDED|95.0|-2.115|1.15|||||Mean difference of percent change off BMD from baseline to end-of-treatment between active treatment groups (transdermal and SC injection).|||1.150|-2.115|
72330954|NCT01942668|144188249|SUPERIORITY||Mean Difference (Final Values)|-16.58|STANDARD_ERROR_OF_MEAN|3.44|<|0.001|TWO_SIDED|95.0|-23.33|-9.82||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|Each co-primary endpt in each dose group tested at alpha=0.05;multiple dose groups vs. PBO comparisons are conducted using gatekeeping procedure|Adjusted for baseline using MMRM|||-9.82|-23.33|<0.001
72330955|NCT01942668|144188249|SUPERIORITY||Mean Difference (Final Values)|-15.07|STANDARD_ERROR_OF_MEAN|3.39|<|0.001|TWO_SIDED|95.0|-21.72|-8.42||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|Each co-primary endpt in each dose group tested at alpha=0.05;multiple dose groups vs. PBO comparisons are conducted using gatekeeping procedure|Adjusted for baseline using MMRM|||-8.42|-21.72|<0.001
72330956|NCT01942668|144188249|SUPERIORITY||Mean Difference (Final Values)|-10.79|STANDARD_ERROR_OF_MEAN|3.41||0.002|TWO_SIDED|95.0|-17.48|-4.1||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|Each co-primary endpt in each dose group tested at alpha=0.05;multiple dose groups vs. PBO comparisons are conducted using gatekeeping procedure|Adjusted for baseline using MMRM|||-4.10|-17.48|0.002
72330957|NCT01942668|144188249|SUPERIORITY||Mean Difference (Final Values)|-11.71|STANDARD_ERROR_OF_MEAN|3.36|<|0.001|TWO_SIDED|95.0|-18.31|-5.11||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|Each co-primary endpt in each dose group tested at alpha=0.05;multiple dose groups vs. PBO comparisons are conducted using gatekeeping procedure|Adjusted for baseline using MMRM|||-5.11|-18.31|<0.001
72330958|NCT01942668|144188250|SUPERIORITY||Mean Difference (Final Values)|-0.13|STANDARD_ERROR_OF_MEAN|0.061||0.031|TWO_SIDED|95.0|-0.25|-0.01||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 4|Mixed Models Analysis|Each co-primary endpt in each dose group tested at alpha=0.05;multiple dose groups vs. PBO comparisons are conducted using gatekeeping procedure|Adjusted for baseline using MMRM|||-0.01|-0.25|0.031
72330959|NCT01942668|144188250|SUPERIORITY||Mean Difference (Final Values)|-0.17|STANDARD_ERROR_OF_MEAN|0.06||0.005|TWO_SIDED|95.0|-0.28|-0.05||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 4|Mixed Models Analysis|Each co-primary endpt in each dose group tested at alpha=0.05;multiple dose groups vs. PBO comparisons are conducted using gatekeeping procedure|Adjusted for baseline using MMRM|||-0.05|-0.28|0.005
72330960|NCT01942668|144188250|SUPERIORITY||Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.06||0.401|TWO_SIDED|95.0|-0.17|0.07||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 4|Mixed Models Analysis|Each co-primary endpt in each dose group tested at alpha=0.05;multiple dose groups vs. PBO comparisons are conducted using gatekeeping procedure|Adjusted for baseline using MMRM|||0.07|-0.17|0.401
72330961|NCT01942668|144188250|SUPERIORITY||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.059||0.1|TWO_SIDED|95.0|-0.21|0.02||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 4|Mixed Models Analysis|Each co-primary endpt in each dose group tested at alpha=0.05;multiple dose groups vs. PBO comparisons are conducted using gatekeeping procedure|Adjusted for baseline using MMRM|||0.02|-0.21|0.100
72330962|NCT01942668|144188251|SUPERIORITY||Mean Difference (Final Values)|-0.57|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.77|-0.38||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|Each co-primary endpt in each dose group tested at alpha=0.05;multiple dose groups vs. PBO comparisons are conducted using gatekeeping procedure|Adjusted for baseline using MMRM|||-0.38|-0.77|<0.001
72330963|NCT01942668|144188251|SUPERIORITY||Mean Difference (Final Values)|-0.39|STANDARD_ERROR_OF_MEAN|0.099|<|0.001|TWO_SIDED|95.0|-0.59|-0.2||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|Each co-primary endpt in each dose group tested at alpha=0.05;multiple dose groups vs. PBO comparisons are conducted using gatekeeping procedure|Adjusted for baseline using MMRM|||-0.20|-0.59|<0.001
72330964|NCT01942668|144188251|SUPERIORITY||Mean Difference (Final Values)|-0.24|STANDARD_ERROR_OF_MEAN|0.1||0.018|TWO_SIDED|95.0|-0.43|-0.04||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|Each co-primary endpt in each dose group tested at alpha=0.05;multiple dose groups vs. PBO comparisons are conducted using gatekeeping procedure|Adjusted for baseline using MMRM|||-0.04|-0.43|0.018
72330965|NCT01942668|144188251|SUPERIORITY||Mean Difference (Final Values)|-0.16|STANDARD_ERROR_OF_MEAN|0.098||0.096|TWO_SIDED|95.0|-0.36|0.03||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|Each co-primary endpt in each dose group tested at alpha=0.05;multiple dose groups vs. PBO comparisons are conducted using gatekeeping procedure|Adjusted for baseline using MMRM|||0.03|-0.36|0.096
72330966|NCT01942668|144188252|OTHER|Per FDA guidance hyperplasia proportion must be \<=1% with an upper bound of the one-sided 95% confidence interval \<=4%.|incidence rate|0.0|||||ONE_SIDED|95.0||1.06||Between group comparison was not performed.|||This calculation is based on a binomial distribution.|Between group comparison is not intended. The purpose of the analysis is to calculate the incidence rate and the 95% CI of endometrial hyperplasia per FDA published guidance for Combined Estradiol 1 mg / Progesterone 100 mg.||1.06||
72330967|NCT01942668|144188252|OTHER|Per FDA guidance hyperplasia proportion must be \<=1% with an upper bound of the one-sided 95% confidence interval \<=4%.|incidence rate|0.0|||||ONE_SIDED|95.0||0.98||Between group comparison was not performed.|||This calculation is based on a binomial distribution.|Between group comparison is not intended. The purpose of the analysis is to calculate the incidence rate and the 95% CI of endometrial hyperplasia per FDA published guidance for Combined Estradiol 0.5 mg / Progesterone 100 mg.||0.98||
72330968|NCT01942668|144188252|OTHER|Per FDA guidance hyperplasia proportion must be \<=1% with an upper bound of the one-sided 95% confidence interval \<=4%.|incidence rate|0.0|||||ONE_SIDED|95.0||0.97||Between group comparison was not performed.|||This calculation is based on a binomial distribution.|Between group comparison is not intended. The purpose of the analysis is to calculate the incidence rate and the 95% CI of endometrial hyperplasia per FDA published guidance for Combined Estradiol 0.5 mg / Progesterone 50 mg.||0.97||
72330969|NCT01942668|144188252|OTHER|Per FDA guidance hyperplasia proportion must be \<=1% with an upper bound of the one-sided 95% confidence interval \<=4%.|incidence rate|0.0|||||ONE_SIDED|95.0||1.09||Between group comparison was not performed.|||This calculation is based on a binomial distribution.|Between group comparison is not intended. The purpose of the analysis is to calculate the incidence rate and the 95% CI of endometrial hyperplasia per FDA published guidance for Combined Estradiol 0.25 mg / Progesterone 50 mg.||1.09||
72330970|NCT01942668|144188252|OTHER|Per FDA guidance hyperplasia proportion must be \<=1% with an upper bound of the one-sided 95% confidence interval \<=4%.|incidence rate|0.0|||||ONE_SIDED|95.0||3.2||Between group comparison was not performed.|||This calculation is based on a binomial distribution.|Between group comparison is not intended. The purpose of the analysis is to calculate the incidence rate and the 95% CI of endometrial hyperplasia per FDA published guidance for Placebo.||3.20||
72330971|NCT01942668|144188253|OTHER|Per FDA guidance hyperplasia proportion must be \<=1% with an upper bound of the one-sided 95% confidence interval \<=4%.|incidence rate|0.0|||||ONE_SIDED|95.0||1.06||Between group comparison was not performed.|||This calculation is based on a binomial distribution.|Between group comparison is not intended. The purpose of the analysis is to calculate the incidence rate and the 95% CI of endometrial hyperplasia per FDA published guidance for Combined Estradiol 1 mg / Progesterone 100 mg.||1.06||
72330972|NCT01942668|144188253|OTHER|Per FDA guidance hyperplasia proportion must be \<=1% with an upper bound of the one-sided 95% confidence interval \<=4%.|incidence rate|0.0|||||ONE_SIDED|95.0||0.98||Between group comparison was not performed.|||This calculation is based on a binomial distribution.|Between group comparison is not intended. The purpose of the analysis is to calculate the incidence rate and the 95% CI of endometrial hyperplasia per FDA published guidance for Combined Estradiol 0.5 mg / Progesterone 100 mg.||0.98||
72330973|NCT01942668|144188253|OTHER|Per FDA guidance hyperplasia proportion must be \<=1% with an upper bound of the one-sided 95% confidence interval \<=4%.|incidence rate|0.0|||||ONE_SIDED|95.0||0.97||Between group comparison was not performed.|||This calculation is based on a binomial distribution.|Between group comparison is not intended. The purpose of the analysis is to calculate the incidence rate and the 95% CI of endometrial hyperplasia per FDA published guidance for Combined Estradiol 0.5 mg / Progesterone 50 mg.||0.97||
72330974|NCT01942668|144188253|OTHER|Per FDA guidance hyperplasia proportion must be \<=1% with an upper bound of the one-sided 95% confidence interval \<=4%.|incidence rate|0.0|||||ONE_SIDED|95.0||1.09||Between group comparison was not performed.|||This calculation is based on a binomial distribution.|Between group comparison is not intended. The purpose of the analysis is to calculate the incidence rate and the 95% CI of endometrial hyperplasia per FDA published guidance for Combined Estradiol 0.25 mg / Progesterone 50 mg.||1.09||
72330975|NCT01942668|144188253|OTHER|Per FDA guidance hyperplasia proportion must be \<=1% with an upper bound of the one-sided 95% confidence interval \<=4%.|incidence rate|0.0|||||ONE_SIDED|95.0||3.2||Between group comparison was not performed.|||This calculation is based on a binomial distribution.|Between group comparison is not intended. The purpose of the analysis is to calculate the incidence rate and the 95% CI of endometrial hyperplasia per FDA published guidance for Placebo.||3.20||
72330976|NCT01942668|144188254|SUPERIORITY||Mean Difference (Final Values)|1.36|STANDARD_ERROR_OF_MEAN|2.51||0.588|TWO_SIDED|95.0|-3.57|6.3||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 1|Mixed Models Analysis||Adjusted for baseline using MMRM|||6.30|-3.57|0.588
72330977|NCT01942668|144188254|SUPERIORITY||Mean Difference (Final Values)|1.29|STANDARD_ERROR_OF_MEAN|2.47||0.601|TWO_SIDED|95.0|-3.56|6.15||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 1|Mixed Models Analysis||Adjusted for baseline using MMRM|||6.15|-3.56|0.601
72330978|NCT01942668|144188254|SUPERIORITY||Mean Difference (Final Values)|3.17|STANDARD_ERROR_OF_MEAN|2.49||0.202|TWO_SIDED|95.0|-1.71|8.06||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 1|Mixed Models Analysis||Adjusted for baseline using MMRM|||8.06|-1.71|0.202
72330979|NCT01942668|144188254|SUPERIORITY||Mean Difference (Final Values)|-1.93|STANDARD_ERROR_OF_MEAN|2.46||0.431|TWO_SIDED|95.0|-6.76|2.89||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 1|Mixed Models Analysis||Adjusted for baseline using MMRM|||2.89|-6.76|0.431
72330980|NCT01942668|144188255|SUPERIORITY||Mean Difference (Final Values)|-4.35|STANDARD_ERROR_OF_MEAN|3.05||0.154|TWO_SIDED|95.0|-10.34|1.64||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 2|Mixed Models Analysis||Adjusted for baseline using MMRM|||1.64|-10.34|0.154
72330981|NCT01942668|144188255|SUPERIORITY||Mean Difference (Final Values)|-0.17|STANDARD_ERROR_OF_MEAN|3.0||0.956|TWO_SIDED|95.0|-6.06|5.73||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 2|Mixed Models Analysis||Adjusted for baseline using MMRM|||5.73|-6.06|0.956
72330982|NCT01942668|144188255|SUPERIORITY||Mean Difference (Final Values)|3.54|STANDARD_ERROR_OF_MEAN|3.01||0.24|TWO_SIDED|95.0|-2.37|9.46||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 2|Mixed Models Analysis||Adjusted for baseline using MMRM|||9.46|-2.37|0.240
72330983|NCT01942668|144188255|SUPERIORITY||Mean Difference (Final Values)|-2.77|STANDARD_ERROR_OF_MEAN|2.98||0.353|TWO_SIDED|95.0|-8.62|3.08||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 2|Mixed Models Analysis||Adjusted for baseline using MMRM|||3.08|-8.62|0.353
72330984|NCT01942668|144188256|SUPERIORITY||Mean Difference (Final Values)|-8.56|STANDARD_ERROR_OF_MEAN|3.16||0.007|TWO_SIDED|95.0|-14.75|-2.36||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 3|Mixed Models Analysis||Adjusted for baseline using MMRM|||-2.36|-14.75|0.007
72422484|NCT01674621|144355975|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.517|||||TWO_SIDED|95.0|-1.106|2.139|||||Mean difference of percent change off BMD from baseline to end-of-treatment between active treatment groups (transdermal and SC injection).|||2.139|-1.106|
72330985|NCT01942668|144188256|SUPERIORITY||Mean Difference (Final Values)|-3.76|STANDARD_ERROR_OF_MEAN|3.11||0.227|TWO_SIDED|95.0|-9.86|2.35||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 3|Mixed Models Analysis||Adjusted for baseline using MMRM|||2.35|-9.86|0.227
72330986|NCT01942668|144188256|SUPERIORITY||Mean Difference (Final Values)|-1.65|STANDARD_ERROR_OF_MEAN|3.12||0.597|TWO_SIDED|95.0|-7.77|4.47||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 3|Mixed Models Analysis||Adjusted for baseline using MMRM|||4.47|-7.77|0.597
72330987|NCT01942668|144188256|SUPERIORITY||Mean Difference (Final Values)|-7.24|STANDARD_ERROR_OF_MEAN|3.08||0.019|TWO_SIDED|95.0|-13.28|-1.19||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 3|Mixed Models Analysis||Adjusted for baseline using MMRM|||-1.19|-13.28|0.019
72330988|NCT01942668|144188257|SUPERIORITY||Mean Difference (Final Values)|-12.81|STANDARD_ERROR_OF_MEAN|3.3|<|0.001|TWO_SIDED|95.0|-19.29|-6.32||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 4|Mixed Models Analysis||Adjusted for baseline using MMRM|||-6.32|-19.29|<0.001
72330989|NCT01942668|144188257|SUPERIORITY||Mean Difference (Final Values)|-8.07|STANDARD_ERROR_OF_MEAN|3.25||0.013|TWO_SIDED|95.0|-14.46|-1.68||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 4|Mixed Models Analysis||Adjusted for baseline using MMRM|||-1.68|-14.46|0.013
72330990|NCT01942668|144188257|SUPERIORITY||Mean Difference (Final Values)|-4.81|STANDARD_ERROR_OF_MEAN|3.26||0.141|TWO_SIDED|95.0|-11.21|1.59||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 4|Mixed Models Analysis||Adjusted for baseline using MMRM|||1.59|-11.21|0.141
72330991|NCT01942668|144188257|SUPERIORITY||Mean Difference (Final Values)|-10.4|STANDARD_ERROR_OF_MEAN|3.22||0.001|TWO_SIDED|95.0|-16.73|-4.08||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 4|Mixed Models Analysis||Adjusted for baseline using MMRM|||-4.08|-16.73|0.001
72330992|NCT01942668|144188258|SUPERIORITY||Mean Difference (Final Values)|-15.59|STANDARD_ERROR_OF_MEAN|3.35|<|0.001|TWO_SIDED|95.0|-22.16|-9.02||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 5|Mixed Models Analysis||Adjusted for baseline using MMRM|||-9.02|-22.16|<0.001
72330993|NCT01942668|144188258|SUPERIORITY||Mean Difference (Final Values)|-9.88|STANDARD_ERROR_OF_MEAN|3.29||0.003|TWO_SIDED|95.0|-16.34|-3.41||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 5|Mixed Models Analysis||Adjusted for baseline using MMRM|||-3.41|-16.34|0.003
72330994|NCT01942668|144188258|SUPERIORITY||Mean Difference (Final Values)|-5.9|STANDARD_ERROR_OF_MEAN|3.31||0.075|TWO_SIDED|95.0|-12.4|0.59||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 5|Mixed Models Analysis||Adjusted for baseline using MMRM|||0.59|-12.40|0.075
72330995|NCT01942668|144188258|SUPERIORITY||Mean Difference (Final Values)|-12.05|STANDARD_ERROR_OF_MEAN|3.27|<|0.001|TWO_SIDED|95.0|-18.47|-5.64||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 5|Mixed Models Analysis||Adjusted for baseline using MMRM|||-5.64|-18.47|<0.001
72330996|NCT01942668|144188259|SUPERIORITY||Mean Difference (Final Values)|-17.87|STANDARD_ERROR_OF_MEAN|3.44|<|0.001|TWO_SIDED|95.0|-24.57|-11.05||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 6|Mixed Models Analysis||Adjusted for baseline using MMRM|||-11.05|-24.57|<0.001
72330997|NCT01942668|144188259|SUPERIORITY||Mean Difference (Final Values)|-11.35|STANDARD_ERROR_OF_MEAN|3.39|<|0.001|TWO_SIDED|95.0|-18.0|-4.7||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 6|Mixed Models Analysis||Adjusted for baseline using MMRM|||-4.70|-18.00|<0.001
72330998|NCT01942668|144188259|SUPERIORITY||Mean Difference (Final Values)|-7.82|STANDARD_ERROR_OF_MEAN|3.4||0.022|TWO_SIDED|95.0|-14.5|-1.14||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 6|Mixed Models Analysis||Adjusted for baseline using MMRM|||-1.14|-14.50|0.022
72330999|NCT01942668|144188259|SUPERIORITY||Mean Difference (Final Values)|-12.51|STANDARD_ERROR_OF_MEAN|3.36|<|0.001|TWO_SIDED|95.0|-19.11|-5.91||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 6|Mixed Models Analysis||Adjusted for baseline using MMRM|||-5.91|-19.11|<0.001
72331000|NCT01942668|144188260|SUPERIORITY||Mean Difference (Final Values)|-17.75|STANDARD_ERROR_OF_MEAN|3.41|<|0.001|TWO_SIDED|95.0|-24.45|-11.06||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 7|Mixed Models Analysis||Adjusted for baseline using MMRM|||-11.06|-24.45|<0.001
72422485|NCT01674621|144355976|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2549||||||Threshold for significance at 0.05 level.|Dunnett's test|P-value from Dunnett's test comparing percent change of BSAP from baseline to end-of-treatment to each transdermal dose group versus placebo.||||||0.2549
72422486|NCT01674621|144355976|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9115||||||Threshold for significance at 0.05 level.|Dunnett's test|P-value from Dunnett's test comparing percent change of BSAP from baseline to end-of-treatment to each transdermal dose group versus placebo.||||||0.9115
72422487|NCT01674621|144355976|SUPERIORITY_OR_OTHER_LEGACY|||||||0.239||||||Threshold for significance at 0.05 level.|Dunnett's test|P-value from Dunnett's test comparing percent change of BSAP from baseline to end-of-treatment to each transdermal dose group versus placebo.||||||0.2390
72422488|NCT01674621|144355976|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-22.146|||||TWO_SIDED|95.0|-40.501|-3.79|||||Mean difference of percent change from baseline to end-of-treatment between active treatment groups (transdermal and SC injection).|||-3.790|-40.501|
72422489|NCT01674621|144355976|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-12.086|||||TWO_SIDED|95.0|-30.543|6.372|||||Mean difference of percent change from baseline to end-of-treatment between active treatment groups (transdermal and SC injection).|||6.372|-30.543|
72422490|NCT01674621|144355976|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-22.828|||||TWO_SIDED|95.0|-41.614|-4.041|||||Mean difference of percent change from baseline to end-of-treatment between active treatment groups (transdermal and SC injection).|||-4.041|-41.614|
72422491|NCT01674621|144355977|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1632||||||Threshold for significance at 0.05 level.|Dunnett's test|P-value from Dunnett's test comparing percent change of PICP from baseline to end-of-treatment to each transdermal dose group versus placebo.||||||0.1632
72422492|NCT01674621|144355977|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9834||||||Threshold for significance at 0.05 level.|Dunnett's test|P-value from Dunnett's test comparing percent change of PICP from baseline to end-of-treatment to each transdermal dose group versus placebo.||||||0.9834
72422493|NCT01674621|144355977|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2179||||||Threshold for significance at 0.05 level.|Dunnett's test|P-value from Dunnett's test comparing percent change of PICP from baseline to end-of-treatment (EOT) to each transdermal dose group versus placebo.||||||0.2179
72422494|NCT01674621|144355977|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-27.541|||||TWO_SIDED|95.0|-48.557|-6.525|||||Mean difference of percent change from baseline to end of treatment between the active treatment groups (transdermal and SC injection).|||-6.525|-48.557|
72422495|NCT01674621|144355977|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-18.702|||||TWO_SIDED|95.0|-39.835|2.43|||||Mean difference of percent change from baseline to end of treatment between the active treatment groups (transdermal and SC injection).|||2.430|-39.835|
72422496|NCT01674621|144355977|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-26.914|||||TWO_SIDED|95.0|-48.424|-5.405|||||Mean difference of percent change from baseline to end of treatment between the active treatment groups (transdermal and SC injection).|||-5.405|-48.424|
72422497|NCT01674621|144355978|SUPERIORITY_OR_OTHER_LEGACY|||||||1||||||Threshold for significance at 0.05 level.|Dunnett's test|P-value from Dunnett's test comparing percent change of serum osteocalcin from baseline to EOT to each transdermal dose group versus placebo.||||||1.0000
72422498|NCT01674621|144355978|SUPERIORITY_OR_OTHER_LEGACY|||||||0.12||||||Threshold for significance at 0.05 level.|Dunnett's test|P-value from Dunnett's test comparing percent change of serum osteocalcin from baseline to EOT to each transdermal dose group versus placebo.||||||0.1200
72422499|NCT01674621|144355978|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9998||||||Threshold for significance at 0.05 level.|Dunnett's test|P-value from Dunnett's test comparing percent change of serum osteocalcin from baseline to EOT to each transdermal dose group versus placebo.||||||0.9998
72422500|NCT01674621|144355978|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-73.906|||||TWO_SIDED|95.0|-96.926|-50.886|||||Mean difference of percent change from baseline to end of treatment between the active treatment groups (transdermal and SC injection).|||-50.886|-96.926|
72422501|NCT01674621|144355978|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-62.872|||||TWO_SIDED|95.0|-86.019|-39.725|||||Mean difference of percent change from baseline to end of treatment between the active treatment groups (transdermal and SC injection).|||-39.725|-86.019|
72422502|NCT01674621|144355978|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-73.367|||||TWO_SIDED|95.0|-96.927|-49.807|||||Mean difference of percent change from baseline to end of treatment between the active treatment groups (transdermal and SC injection).|||-49.807|-96.927|
72422503|NCT01674621|144355979|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8569||||||Threshold for significance at 0.05 level.|Dunnett's test|P-value from Dunnett's test comparing percent change of PINP from baseline to end-of-treatment to each transdermal dose group versus placebo.||||||0.8569
72422504|NCT01674621|144355979|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6091||||||Threshold for significance at 0.05 level.|Dunnett's test|P-value from Dunnett's test comparing percent change of PINP from baseline to end-of-treatment to each transdermal dose group versus placebo.||||||0.6091
72422505|NCT01674621|144355979|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9999||||||Threshold for significance at 0.05 level.|Dunnett's test|P-value from Dunnett's test comparing percent change of PINP from baseline to EOT to each transdermal dose group versus placebo.||||||0.9999
72422506|NCT01674621|144355979|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-110.398|||||TWO_SIDED|95.0|-156.966|-63.831|||||Mean difference of percent change from baseline to end of treatment between the active treatment groups (transdermal and SC injection).|||-63.831|-156.966|
72422507|NCT01674621|144355979|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-96.115|||||TWO_SIDED|95.0|-142.94|-49.29|||||Mean difference of percent change from baseline to end of treatment between the active treatment groups (transdermal and SC injection).|||-49.290|-142.940|
72331001|NCT01942668|144188260|SUPERIORITY||Mean Difference (Final Values)|-13.29|STANDARD_ERROR_OF_MEAN|3.36|<|0.001|TWO_SIDED|95.0|-19.88|-6.7||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 7|Mixed Models Analysis||Adjusted for baseline using MMRM|||-6.70|-19.88|<0.001
72331002|NCT01942668|144188260|SUPERIORITY||Mean Difference (Final Values)|-10.22|STANDARD_ERROR_OF_MEAN|3.37||0.003|TWO_SIDED|95.0|-16.83|-3.6||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 7|Mixed Models Analysis||Adjusted for baseline using MMRM|||-3.60|-16.83|0.003
72331003|NCT01942668|144188260|SUPERIORITY||Mean Difference (Final Values)|-13.61|STANDARD_ERROR_OF_MEAN|3.33|<|0.001|TWO_SIDED|95.0|-20.15|-7.07||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 7|Mixed Models Analysis||Adjusted for baseline using MMRM|||-7.07|-20.15|<0.001
72331004|NCT01942668|144188261|SUPERIORITY||Mean Difference (Final Values)|-16.63|STANDARD_ERROR_OF_MEAN|3.42|<|0.001|TWO_SIDED|95.0|-23.35|-9.91||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 8|Mixed Models Analysis||Adjusted for baseline using MMRM|||-9.91|-23.35|<0.001
72331005|NCT01942668|144188261|SUPERIORITY||Mean Difference (Final Values)|-12.97|STANDARD_ERROR_OF_MEAN|3.37|<|0.001|TWO_SIDED|95.0|-19.58|-6.36||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 8|Mixed Models Analysis||Adjusted for baseline using MMRM|||-6.36|-19.58|<0.001
72331006|NCT01942668|144188261|SUPERIORITY||Mean Difference (Final Values)|-9.63|STANDARD_ERROR_OF_MEAN|3.38||0.005|TWO_SIDED|95.0|-16.27|-2.99||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 8|Mixed Models Analysis||Adjusted for baseline using MMRM|||-2.99|-16.27|0.005
72331007|NCT01942668|144188261|SUPERIORITY||Mean Difference (Final Values)|-11.97|STANDARD_ERROR_OF_MEAN|3.34|<|0.001|TWO_SIDED|95.0|-18.53|-5.41||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 8|Mixed Models Analysis||Adjusted for baseline using MMRM|||-5.41|-18.53|<0.001
72331008|NCT01942668|144188262|SUPERIORITY||Mean Difference (Final Values)|-17.12|STANDARD_ERROR_OF_MEAN|3.4|<|0.001|TWO_SIDED|95.0|-23.79|-10.44||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 9|Mixed Models Analysis||Adjusted for baseline using MMRM|||-10.44|-23.79|<0.001
72331009|NCT01942668|144188262|SUPERIORITY||Mean Difference (Final Values)|-15.58|STANDARD_ERROR_OF_MEAN|3.34|<|0.001|TWO_SIDED|95.0|-22.15|-9.01||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 9|Mixed Models Analysis||Adjusted for baseline using MMRM|||-9.01|-22.15|<0.001
72331010|NCT01942668|144188262|SUPERIORITY||Mean Difference (Final Values)|-11.05|STANDARD_ERROR_OF_MEAN|3.36||0.001|TWO_SIDED|95.0|-17.65|-4.44||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 9|Mixed Models Analysis||Adjusted for baseline using MMRM|||-4.44|-17.65|0.001
72331011|NCT01942668|144188262|SUPERIORITY||Mean Difference (Final Values)|-13.02|STANDARD_ERROR_OF_MEAN|3.32|<|0.001|TWO_SIDED|95.0|-19.54|-6.5||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 9|Mixed Models Analysis||Adjusted for baseline using MMRM|||-6.50|-19.54|<0.001
72422508|NCT01674621|144355979|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-104.418|||||TWO_SIDED|95.0|-152.079|-56.758|||||Mean difference of percent change from baseline to end of treatment between the active treatment groups (transdermal and SC injection).|||-56.758|-152.079|
72422509|NCT01674621|144355980|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3483||||||Threshold for significance at 0.05 level.|Dunnett's test|P-value from Dunnett's test comparing percent change of CTXI from baseline to end-of-treatment to each transdermal dose group versus placebo.||||||0.3483
72331012|NCT01942668|144188263|SUPERIORITY||Mean Difference (Final Values)|-16.8|STANDARD_ERROR_OF_MEAN|3.45|<|0.001|TWO_SIDED|95.0|-23.58|-10.03||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 10|Mixed Models Analysis||Adjusted for baseline using MMRM|||-10.03|-23.58|<0.001
72331013|NCT01942668|144188263|SUPERIORITY||Mean Difference (Final Values)|-15.66|STANDARD_ERROR_OF_MEAN|3.4|<|0.001|TWO_SIDED|95.0|-22.32|-8.99||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 10|Mixed Models Analysis||Adjusted for baseline using MMRM|||-8.99|-22.32|<0.001
72422510|NCT01674621|144355980|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6839||||||Threshold for significance at 0.05 level.|Dunnett's test|P-value from Dunnett's test comparing percent change of CTXI from baseline to end-of-treatment to each transdermal dose group versus placebo.||||||0.6839
72331014|NCT01942668|144188263|SUPERIORITY||Mean Difference (Final Values)|-11.2|STANDARD_ERROR_OF_MEAN|3.41||0.001|TWO_SIDED|95.0|-17.9|-4.49||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 10|Mixed Models Analysis||Adjusted for baseline using MMRM|||-4.49|-17.90|0.001
72331015|NCT01942668|144188263|SUPERIORITY||Mean Difference (Final Values)|-12.16|STANDARD_ERROR_OF_MEAN|3.37|<|0.001|TWO_SIDED|95.0|-18.78|-5.55||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 10|Mixed Models Analysis||Adjusted for baseline using MMRM|||-5.55|-18.78|<0.001
72331016|NCT01942668|144188264|SUPERIORITY||Mean Difference (Final Values)|-18.11|STANDARD_ERROR_OF_MEAN|3.47|<|0.001|TWO_SIDED|95.0|-24.92|-11.29||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 11|Mixed Models Analysis||Adjusted for baseline using MMRM|||-11.29|-24.92|<0.001
72422511|NCT01674621|144355980|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1067||||||Threshold for significance at 0.05 level.|Dunnett's test|P-value from Dunnett's test comparing percent change of CTXI from baseline to end-of-treatment to each transdermal dose group versus placebo.||||||0.1067
72331017|NCT01942668|144188264|SUPERIORITY||Mean Difference (Final Values)|-16.45|STANDARD_ERROR_OF_MEAN|3.42|<|0.001|TWO_SIDED|95.0|-23.17|-9.74||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 11|Mixed Models Analysis||Adjusted for baseline using MMRM|||-9.74|-23.17|<0.001
72331018|NCT01942668|144188264|SUPERIORITY||Mean Difference (Final Values)|-12.41|STANDARD_ERROR_OF_MEAN|3.44|<|0.001|TWO_SIDED|95.0|-19.15|-5.66||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 11|Mixed Models Analysis||Adjusted for baseline using MMRM|||-5.66|-19.15|<0.001
72331019|NCT01942668|144188264|SUPERIORITY||Mean Difference (Final Values)|-13.6|STANDARD_ERROR_OF_MEAN|3.39|<|0.001|TWO_SIDED|95.0|-20.26|-6.93||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 11|Mixed Models Analysis||Adjusted for baseline using MMRM|||-6.93|-20.26|<0.001
72331020|NCT01942668|144188265|SUPERIORITY||Mean Difference (Final Values)|-16.58|STANDARD_ERROR_OF_MEAN|3.44|<|0.001|TWO_SIDED|95.0|-23.33|-9.82||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis||Adjusted for baseline using MMRM|||-9.82|-23.33|<0.001
72331021|NCT01942668|144188265|SUPERIORITY||Mean Difference (Final Values)|-15.07|STANDARD_ERROR_OF_MEAN|3.39|<|0.001|TWO_SIDED|95.0|-21.72|-8.42||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis||Adjusted for baseline using MMRM|||-8.42|-21.72|<0.001
72331022|NCT01942668|144188265|SUPERIORITY||Mean Difference (Final Values)|-10.79|STANDARD_ERROR_OF_MEAN|3.41||0.002|TWO_SIDED|95.0|-17.48|-4.1||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis||Adjusted for baseline using MMRM|||-4.10|-17.48|0.002
72331023|NCT01942668|144188265|SUPERIORITY||Mean Difference (Final Values)|-11.71|STANDARD_ERROR_OF_MEAN|3.36|<|0.001|TWO_SIDED|95.0|-18.31|-5.11||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis||Adjusted for baseline using MMRM|||-5.11|-18.31|<0.001
72331024|NCT01942668|144188266|SUPERIORITY||Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.034||0.801|TWO_SIDED|95.0|-0.06|0.08||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 1|Mixed Models Analysis||Adjusted for baseline using MMRM|||0.08|-0.06|0.801
72331025|NCT01942668|144188266|SUPERIORITY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.034||0.991|TWO_SIDED|95.0|-0.07|0.07||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 1|Mixed Models Analysis||Adjusted for baseline using MMRM|||0.07|-0.07|0.991
72331026|NCT01942668|144188266|SUPERIORITY||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.034||0.642|TWO_SIDED|95.0|-0.05|0.08||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 1|Mixed Models Analysis||Adjusted for baseline using MMRM|||0.08|-0.05|0.642
72331027|NCT01942668|144188266|SUPERIORITY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.034||0.928|TWO_SIDED|95.0|-0.07|0.06||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 1|Mixed Models Analysis||Adjusted for baseline using MMRM|||0.06|-0.07|0.928
72331028|NCT01942668|144188267|SUPERIORITY||Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.043||0.231|TWO_SIDED|95.0|-0.14|0.03||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 2|Mixed Models Analysis||Adjusted for baseline using MMRM|||0.03|-0.14|0.231
72331029|NCT01942668|144188267|SUPERIORITY||Mean Difference (Final Values)|-0.06|STANDARD_ERROR_OF_MEAN|0.042||0.173|TWO_SIDED|95.0|-0.14|0.03||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 2|Mixed Models Analysis||Adjusted for baseline using MMRM|||0.03|-0.14|0.173
72331030|NCT01942668|144188267|SUPERIORITY||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.042||0.717|TWO_SIDED|95.0|-0.07|0.1||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 2|Mixed Models Analysis||Adjusted for baseline using MMRM|||0.10|-0.07|0.717
72331031|NCT01942668|144188267|SUPERIORITY||Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.042||0.849|TWO_SIDED|95.0|-0.09|0.07||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 2|Mixed Models Analysis||Adjusted for baseline using MMRM|||0.07|-0.09|0.849
72331032|NCT01942668|144188268|SUPERIORITY||Mean Difference (Final Values)|-0.11|STANDARD_ERROR_OF_MEAN|0.052||0.039|TWO_SIDED|95.0|-0.21|-0.01||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 3|Mixed Models Analysis||Adjusted for baseline using MMRM|||-0.01|-0.21|0.039
72331033|NCT01942668|144188268|SUPERIORITY||Mean Difference (Final Values)|-0.11|STANDARD_ERROR_OF_MEAN|0.052||0.03|TWO_SIDED|95.0|-0.21|-0.01||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 3|Mixed Models Analysis||Adjusted for baseline using MMRM|||-0.01|-0.21|0.030
72331034|NCT01942668|144188268|SUPERIORITY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.052||0.946|TWO_SIDED|95.0|-0.1|0.1||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 3|Mixed Models Analysis||Adjusted for baseline using MMRM|||0.10|-0.10|0.946
72331035|NCT01942668|144188268|SUPERIORITY||Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.051||0.309|TWO_SIDED|95.0|-0.15|0.05||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 3|Mixed Models Analysis||Adjusted for baseline using MMRM|||0.05|-0.15|0.309
72331036|NCT01942668|144188269|SUPERIORITY||Mean Difference (Final Values)|-0.13|STANDARD_ERROR_OF_MEAN|0.061||0.031|TWO_SIDED|95.0|-0.25|-0.01||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 4|Mixed Models Analysis||Adjusted for baseline using MMRM|||-0.01|-0.25|0.031
72331037|NCT01942668|144188269|SUPERIORITY||Mean Difference (Final Values)|-0.17|STANDARD_ERROR_OF_MEAN|0.06||0.005|TWO_SIDED|95.0|-0.28|-0.05||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 4|Mixed Models Analysis||Adjusted for baseline using MMRM|||-0.05|-0.28|0.005
72331038|NCT01942668|144188269|SUPERIORITY||Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.06||0.401|TWO_SIDED|95.0|-0.17|0.07||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 4|Mixed Models Analysis||Adjusted for baseline using MMRM|||0.07|-0.17|0.401
72331039|NCT01942668|144188269|SUPERIORITY||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.059||0.1|TWO_SIDED|95.0|-0.21|0.02||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 4|Mixed Models Analysis||Adjusted for baseline using MMRM|||0.02|-0.21|0.100
72331040|NCT01942668|144188270|SUPERIORITY||Mean Difference (Final Values)|-0.23|STANDARD_ERROR_OF_MEAN|0.071||0.001|TWO_SIDED|95.0|-0.37|-0.09||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 5|Mixed Models Analysis||Adjusted for baseline using MMRM|||-0.09|-0.37|0.001
72331041|NCT01942668|144188270|SUPERIORITY||Mean Difference (Final Values)|-0.15|STANDARD_ERROR_OF_MEAN|0.07||0.034|TWO_SIDED|95.0|-0.28|-0.01||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 5|Mixed Models Analysis||Adjusted for baseline using MMRM|||-0.01|-0.28|0.034
72331042|NCT01942668|144188270|SUPERIORITY||Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.07||0.79|TWO_SIDED|95.0|-0.16|0.12||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 5|Mixed Models Analysis||Adjusted for baseline using MMRM|||0.12|-0.16|0.790
72331043|NCT01942668|144188270|SUPERIORITY||Mean Difference (Final Values)|-0.12|STANDARD_ERROR_OF_MEAN|0.069||0.086|TWO_SIDED|95.0|-0.25|0.02||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 5|Mixed Models Analysis||Adjusted for baseline using MMRM|||0.02|-0.25|0.086
72331044|NCT01942668|144188271|SUPERIORITY||Mean Difference (Final Values)|-0.36|STANDARD_ERROR_OF_MEAN|0.084|<|0.001|TWO_SIDED|95.0|-0.53|-0.2||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 6|Mixed Models Analysis||Adjusted for baseline using MMRM|||-0.20|-0.53|<0.001
72422512|NCT01674621|144355980|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-43.721|||||TWO_SIDED|95.0|-75.748|-11.694|||||Mean difference of percent change from baseline to end of treatment between the active treatment groups (transdermal and SC injection).|||-11.694|-75.748|
72331045|NCT01942668|144188271|SUPERIORITY||Mean Difference (Final Values)|-0.18|STANDARD_ERROR_OF_MEAN|0.083||0.03|TWO_SIDED|95.0|-0.34|-0.02||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 6|Mixed Models Analysis||Adjusted for baseline using MMRM|||-0.02|-0.34|0.030
72331046|NCT01942668|144188271|SUPERIORITY||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.083||0.247|TWO_SIDED|95.0|-0.26|0.07||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 6|Mixed Models Analysis||Adjusted for baseline using MMRM|||0.07|-0.26|0.247
72331047|NCT01942668|144188271|SUPERIORITY||Mean Difference (Final Values)|-0.19|STANDARD_ERROR_OF_MEAN|0.082||0.022|TWO_SIDED|95.0|-0.35|-0.03||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 6|Mixed Models Analysis||Adjusted for baseline using MMRM|||-0.03|-0.35|0.022
72331048|NCT01942668|144188272|SUPERIORITY||Mean Difference (Final Values)|-0.37|STANDARD_ERROR_OF_MEAN|0.085|<|0.001|TWO_SIDED|95.0|-0.54|-0.2||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 7|Mixed Models Analysis||Adjusted for baseline using MMRM|||-0.20|-0.54|<0.001
72422513|NCT01674621|144355980|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-39.461|||||TWO_SIDED|95.0|-71.665|-7.257|||||Mean difference of percent change from baseline to end of treatment between the active treatment groups (transdermal and SC injection).|||-7.257|-71.665|
72422514|NCT01674621|144355980|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-49.334|||||TWO_SIDED|95.0|-82.113|-16.555|||||Mean difference of percent change from baseline to end of treatment between the active treatment groups (transdermal and SC injection).|||-16.555|-82.113|
72422515|NCT01148862|144355987|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|32.2||||0.006|||||||ANCOVA|||||||0.006
72331049|NCT01942668|144188272|SUPERIORITY||Mean Difference (Final Values)|-0.25|STANDARD_ERROR_OF_MEAN|0.083||0.002|TWO_SIDED|95.0|-0.42|-0.09||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 7|Mixed Models Analysis||Adjusted for baseline using MMRM|||-0.09|-0.42|0.002
72331050|NCT01942668|144188272|SUPERIORITY||Mean Difference (Final Values)|-0.18|STANDARD_ERROR_OF_MEAN|0.084||0.031|TWO_SIDED|95.0|-0.34|-0.02||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 7|Mixed Models Analysis||Adjusted for baseline using MMRM|||-0.02|-0.34|0.031
72331051|NCT01942668|144188272|SUPERIORITY||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.083||0.016|TWO_SIDED|95.0|-0.36|-0.04||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 7|Mixed Models Analysis||Adjusted for baseline using MMRM|||-0.04|-0.36|0.016
72331052|NCT01942668|144188273|SUPERIORITY||Mean Difference (Final Values)|-0.38|STANDARD_ERROR_OF_MEAN|0.087|<|0.001|TWO_SIDED|95.0|-0.55|-0.21||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 8|Mixed Models Analysis||Adjusted for baseline using MMRM|||-0.21|-0.55|<0.001
72331053|NCT01942668|144188273|SUPERIORITY||Mean Difference (Final Values)|-0.23|STANDARD_ERROR_OF_MEAN|0.086||0.008|TWO_SIDED|95.0|-0.4|-0.06||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 8|Mixed Models Analysis||Adjusted for baseline using MMRM|||-0.06|-0.40|0.008
72331054|NCT01942668|144188273|SUPERIORITY||Mean Difference (Final Values)|-0.15|STANDARD_ERROR_OF_MEAN|0.086||0.087|TWO_SIDED|95.0|-0.32|0.02||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 8|Mixed Models Analysis||Adjusted for baseline using MMRM|||0.02|-0.32|0.087
72331055|NCT01942668|144188273|SUPERIORITY||Mean Difference (Final Values)|-0.14|STANDARD_ERROR_OF_MEAN|0.085||0.092|TWO_SIDED|95.0|-0.31|0.02||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 8|Mixed Models Analysis||Adjusted for baseline using MMRM|||0.02|-0.31|0.092
72331056|NCT01942668|144188274|SUPERIORITY||Mean Difference (Final Values)|-0.48|STANDARD_ERROR_OF_MEAN|0.092|<|0.001|TWO_SIDED|95.0|-0.66|-0.3||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 9|Mixed Models Analysis||Adjusted for baseline using MMRM|||-0.30|-0.66|<0.001
72331057|NCT01942668|144188274|SUPERIORITY||Mean Difference (Final Values)|-0.29|STANDARD_ERROR_OF_MEAN|0.09||0.001|TWO_SIDED|95.0|-0.47|-0.12||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 9|Mixed Models Analysis||Adjusted for baseline using MMRM|||-0.12|-0.47|0.001
72331058|NCT01942668|144188274|SUPERIORITY||Mean Difference (Final Values)|-0.24|STANDARD_ERROR_OF_MEAN|0.091||0.009|TWO_SIDED|95.0|-0.42|-0.06||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 9|Mixed Models Analysis||Adjusted for baseline using MMRM|||-0.06|-0.42|0.009
72331059|NCT01942668|144188274|SUPERIORITY||Mean Difference (Final Values)|-0.24|STANDARD_ERROR_OF_MEAN|0.09||0.007|TWO_SIDED|95.0|-0.42|-0.07||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 9|Mixed Models Analysis||Adjusted for baseline using MMRM|||-0.07|-0.42|0.007
72331060|NCT01942668|144188275|SUPERIORITY||Mean Difference (Final Values)|-0.52|STANDARD_ERROR_OF_MEAN|0.096|<|0.001|TWO_SIDED|95.0|-0.71|-0.33||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 10|Mixed Models Analysis||Adjusted for baseline using MMRM|||-0.33|-0.71|<0.001
72331061|NCT01942668|144188275|SUPERIORITY||Mean Difference (Final Values)|-0.28|STANDARD_ERROR_OF_MEAN|0.094||0.003|TWO_SIDED|95.0|-0.46|-0.09||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 10|Mixed Models Analysis||Adjusted for baseline using MMRM|||-0.09|-0.46|0.003
72331062|NCT01942668|144188275|SUPERIORITY||Mean Difference (Final Values)|-0.23|STANDARD_ERROR_OF_MEAN|0.095||0.016|TWO_SIDED|95.0|-0.41|-0.04||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 10|Mixed Models Analysis||Adjusted for baseline using MMRM|||-0.04|-0.41|0.016
72331063|NCT01942668|144188275|SUPERIORITY||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.094||0.31|TWO_SIDED|95.0|-0.28|0.09||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 10|Mixed Models Analysis||Adjusted for baseline using MMRM|||0.09|-0.28|0.310
72331064|NCT01942668|144188276|SUPERIORITY||Mean Difference (Final Values)|-0.53|STANDARD_ERROR_OF_MEAN|0.098|<|0.001|TWO_SIDED|95.0|-0.72|-0.34||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 11|Mixed Models Analysis||Adjusted for baseline using MMRM|||-0.34|-0.72|<0.001
72331065|NCT01942668|144188276|SUPERIORITY||Mean Difference (Final Values)|-0.37|STANDARD_ERROR_OF_MEAN|0.096|<|0.001|TWO_SIDED|95.0|-0.56|-0.19||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 11|Mixed Models Analysis||Adjusted for baseline using MMRM|||-0.19|-0.56|<0.001
72331066|NCT01942668|144188276|SUPERIORITY||Mean Difference (Final Values)|-0.25|STANDARD_ERROR_OF_MEAN|0.097||0.011|TWO_SIDED|95.0|-0.44|-0.06||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 11|Mixed Models Analysis||Adjusted for baseline using MMRM|||-0.06|-0.44|0.011
72422516|NCT01148862|144355988|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.0||||0.015||95.0|||||ANCOVA|||||||0.015
72422517|NCT00895622|144355997|OTHER||Kappa statistic|0.79|||<|0.0001|TWO_SIDED|95.0|0.71|0.87|||Z test|||"The Kappa (κ) coefficient was used to assess the measure of agreement between the reviewers. κ can be interpreted as follows (κ / Agreement):~\< 0 / Less than chance agreement; 0.01-0.20 / Slight agreement; 0.21-0.40 / Fair agreement; 0.41-0.60 / Moderate agreement; 0.61-0.80 / Substantial agreement; 0.81-0.99 / Almost perfect agreement.~The asymptotic test of the null hypothesis: κ=0 will be performed using the Z-statistic to determine the strength of agreement."||0.87|0.71|<0.0001
72553904|NCT05615935|144639905|SUPERIORITY||Median Difference (Final Values)|-2.64|STANDARD_DEVIATION|6.35||0.02|TWO_SIDED|||||The p-value is adjusted for multiple comparisons using the Bonferroni correction, with a significance threshold of 0.05.|t-test, 2 sided|||||||0.02
72331067|NCT01942668|144188276|SUPERIORITY||Mean Difference (Final Values)|-0.17|STANDARD_ERROR_OF_MEAN|0.096||0.076|TWO_SIDED|95.0|-0.36|0.02||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 11|Mixed Models Analysis||Adjusted for baseline using MMRM|||0.02|-0.36|0.076
72331068|NCT01942668|144188277|SUPERIORITY||Mean Difference (Final Values)|-0.57|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.77|-0.38||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis||Adjusted for baseline using MMRM|||-0.38|-0.77|<0.001
72331069|NCT01942668|144188277|SUPERIORITY||Mean Difference (Final Values)|-0.39|STANDARD_ERROR_OF_MEAN|0.099|<|0.001|TWO_SIDED|95.0|-0.59|-0.2||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis||Adjusted for baseline using MMRM|||-0.20|-0.59|<0.001
72331070|NCT01942668|144188277|SUPERIORITY||Mean Difference (Final Values)|-0.24|STANDARD_ERROR_OF_MEAN|0.1||0.018|TWO_SIDED|95.0|-0.43|-0.04||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis||Adjusted for baseline using MMRM|||-0.04|-0.43|0.018
72331071|NCT01942668|144188277|SUPERIORITY||Mean Difference (Final Values)|-0.16|STANDARD_ERROR_OF_MEAN|0.098||0.096|TWO_SIDED|95.0|-0.36|0.03||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis||Adjusted for baseline using MMRM|||0.03|-0.36|0.096
72331072|NCT01942668|144188278|SUPERIORITY||Mean Difference (Final Values)|0.49|STANDARD_ERROR_OF_MEAN|2.88||0.865|TWO_SIDED|95.0|-5.16|6.14||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 1|Mixed Models Analysis||Adjusted for baseline using MMRM|||6.14|-5.16|0.865
72331073|NCT01942668|144188278|SUPERIORITY||Mean Difference (Final Values)|0.55|STANDARD_ERROR_OF_MEAN|2.83||0.847|TWO_SIDED|95.0|-5.01|6.1||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 1|Mixed Models Analysis||Adjusted for baseline using MMRM|||6.10|-5.01|0.847
72331074|NCT01942668|144188278|SUPERIORITY||Mean Difference (Final Values)|2.09|STANDARD_ERROR_OF_MEAN|2.85||0.463|TWO_SIDED|95.0|-3.5|7.68||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 1|Mixed Models Analysis||Adjusted for baseline using MMRM|||7.68|-3.50|0.463
72331075|NCT01942668|144188278|SUPERIORITY||Mean Difference (Final Values)|-3.55|STANDARD_ERROR_OF_MEAN|2.81||0.207|TWO_SIDED|95.0|-9.07|1.97||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 1|Mixed Models Analysis||Adjusted for baseline using MMRM|||1.97|-9.07|0.207
72331076|NCT01942668|144188279|SUPERIORITY||Mean Difference (Final Values)|-5.07|STANDARD_ERROR_OF_MEAN|3.43||0.14|TWO_SIDED|95.0|-11.8|1.67||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 2|Mixed Models Analysis||Adjusted for baseline using MMRM|||1.67|-11.80|0.140
72331077|NCT01942668|144188279|SUPERIORITY||Mean Difference (Final Values)|-0.08|STANDARD_ERROR_OF_MEAN|3.38||0.982|TWO_SIDED|95.0|-6.7|6.55||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 2|Mixed Models Analysis||Adjusted for baseline using MMRM|||6.55|-6.70|0.982
72331078|NCT01942668|144188279|SUPERIORITY||Mean Difference (Final Values)|2.33|STANDARD_ERROR_OF_MEAN|3.39||0.492|TWO_SIDED|95.0|-4.32|8.98||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 2|Mixed Models Analysis||Adjusted for baseline using MMRM|||8.98|-4.32|0.492
72331079|NCT01942668|144188279|SUPERIORITY||Mean Difference (Final Values)|-4.14|STANDARD_ERROR_OF_MEAN|3.35||0.216|TWO_SIDED|95.0|-10.72|2.43||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 2|Mixed Models Analysis||Adjusted for baseline using MMRM|||2.43|-10.72|0.216
72331080|NCT01942668|144188280|SUPERIORITY||Mean Difference (Final Values)|-10.38|STANDARD_ERROR_OF_MEAN|3.5||0.003|TWO_SIDED|95.0|-17.26|-3.5||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 3|Mixed Models Analysis||Adjusted for baseline using MMRM|||-3.50|-17.26|0.003
72331081|NCT01942668|144188280|SUPERIORITY||Mean Difference (Final Values)|-3.75|STANDARD_ERROR_OF_MEAN|3.45||0.277|TWO_SIDED|95.0|-10.53|3.02||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 3|Mixed Models Analysis||Adjusted for baseline using MMRM|||3.02|-10.53|0.277
72553905|NCT05446870|144639907|OTHER||Posterior probability (%)|100.0|||||||||||||||Posterior probability (based on 20000 sets of model parameters) ctDNA fold change (square root scale) coefficient less than zero in the multivariable logistic regression model of pCR, adjusted for baseline ctDNA and treatment assignment.|||
72331082|NCT01942668|144188280|SUPERIORITY||Mean Difference (Final Values)|-2.95|STANDARD_ERROR_OF_MEAN|3.46||0.394|TWO_SIDED|95.0|-9.75|3.84||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 3|Mixed Models Analysis||Adjusted for baseline using MMRM|||3.84|-9.75|0.394
72331083|NCT01942668|144188280|SUPERIORITY||Mean Difference (Final Values)|-7.86|STANDARD_ERROR_OF_MEAN|3.42||0.022|TWO_SIDED|95.0|-14.58|-1.15||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 3|Mixed Models Analysis||Adjusted for baseline using MMRM|||-1.15|-14.58|0.022
72331084|NCT01942668|144188281|SUPERIORITY||Mean Difference (Final Values)|-15.32|STANDARD_ERROR_OF_MEAN|3.78|<|0.001|TWO_SIDED|95.0|-22.75|-7.89||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 4|Mixed Models Analysis||Adjusted for baseline using MMRM|||-7.89|-22.75|<0.001
72331085|NCT01942668|144188281|SUPERIORITY||Mean Difference (Final Values)|-8.92|STANDARD_ERROR_OF_MEAN|3.73||0.017|TWO_SIDED|95.0|-16.24|-1.6||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 4|Mixed Models Analysis||Adjusted for baseline using MMRM|||-1.60|-16.24|0.017
72331086|NCT01942668|144188281|SUPERIORITY||Mean Difference (Final Values)|-4.56|STANDARD_ERROR_OF_MEAN|3.74||0.223|TWO_SIDED|95.0|-11.9|2.78||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 4|Mixed Models Analysis||Adjusted for baseline using MMRM|||2.78|-11.90|0.223
72331087|NCT01942668|144188281|SUPERIORITY||Mean Difference (Final Values)|-11.32|STANDARD_ERROR_OF_MEAN|3.69||0.002|TWO_SIDED|95.0|-18.57|-4.07||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 4|Mixed Models Analysis||Adjusted for baseline using MMRM|||-4.07|-18.57|0.002
72331088|NCT01942668|144188282|SUPERIORITY||Mean Difference (Final Values)|-17.47|STANDARD_ERROR_OF_MEAN|3.66|<|0.001|TWO_SIDED|95.0|-24.65|-10.28||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 5|Mixed Models Analysis||Adjusted for baseline using MMRM|||-10.28|-24.65|<0.001
72331089|NCT01942668|144188282|SUPERIORITY||Mean Difference (Final Values)|-10.26|STANDARD_ERROR_OF_MEAN|3.6||0.005|TWO_SIDED|95.0|-17.33|-3.18||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 5|Mixed Models Analysis||Adjusted for baseline using MMRM|||-3.18|-17.33|0.005
72331090|NCT01942668|144188282|SUPERIORITY||Mean Difference (Final Values)|-6.21|STANDARD_ERROR_OF_MEAN|3.62||0.087|TWO_SIDED|95.0|-13.31|0.89||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 5|Mixed Models Analysis||Adjusted for baseline using MMRM|||0.89|-13.31|0.087
72331091|NCT01942668|144188282|SUPERIORITY||Mean Difference (Final Values)|-12.66|STANDARD_ERROR_OF_MEAN|3.57|<|0.001|TWO_SIDED|95.0|-19.68|-5.65||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 5|Mixed Models Analysis||Adjusted for baseline using MMRM|||-5.65|-19.68|<0.001
72331092|NCT01942668|144188283|SUPERIORITY||Mean Difference (Final Values)|-20.32|STANDARD_ERROR_OF_MEAN|3.8|<|0.001|TWO_SIDED|95.0|-27.77|-12.87||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 6|Mixed Models Analysis||Adjusted for baseline using MMRM|||-12.87|-27.77|<0.001
72331093|NCT01942668|144188283|SUPERIORITY||Mean Difference (Final Values)|-12.61|STANDARD_ERROR_OF_MEAN|3.73|<|0.001|TWO_SIDED|95.0|-19.95|-5.28||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 6|Mixed Models Analysis||Adjusted for baseline using MMRM|||-5.28|-19.95|<0.001
72422518|NCT02237508|144356014|EQUIVALENCE|"Z7200 was considered bioequivalent to the reference if the following criteria were satisfied:~* the 90%CI for the geometric mean AUC0-t ratio was within the interval 80.00% to 125.00% for both budesonide and formoterol, with and without charcoal blockade and~* the 90%CI for the geometric mean ratio for Cmax was within the wider bioequivalence acceptance limits of (69.84%, 143.19%) for budesonide and (71.92%, 139.04%) for formoterol, respectively with and without charcoal blockade."|Adjusted geometric means ratio|138.87|||<|0.001|TWO_SIDED|90.0|129.09|149.39|||Mixed Models Analysis|||||149.39|129.09|<0.001
72422519|NCT02237508|144356014|EQUIVALENCE|"Z7200 was considered bioequivalent to the reference if the following criteria were satisfied:~* the 90%CI for the geometric mean AUC0-t ratio was within the interval 80.00% to 125.00% for both budesonide and formoterol, with and without charcoal blockade and~* the 90%CI for the geometric mean ratio for Cmax was within the wider bioequivalence acceptance limits of (69.84%, 143.19%) for budesonide and (71.92%, 139.04%) for formoterol, respectively with and without charcoal blockade."|Adjusted geometric means ratio|136.18|||<|0.001|TWO_SIDED|90.0|126.13|147.04|||Mixed Models Analysis|||||147.04|126.13|<0.001
72422520|NCT02237508|144356015|EQUIVALENCE|"Z7200 was considered bioequivalent to the reference if the following criteria were satisfied:~* the 90%CI for the geometric mean AUC0-t ratio was within the interval 80.00% to 125.00% for both budesonide and formoterol, with and without charcoal blockade and~* the 90%CI for the geometric mean ratio for Cmax was within the wider bioequivalence acceptance limits of (69.84%, 143.19%) for budesonide and (71.92%, 139.04%) for formoterol, respectively with and without charcoal blockade."|Adjusted geometric means ratio|119.73||||0.001|TWO_SIDED|90.0|109.4|131.03|||Mixed Models Analysis|||||131.03|109.40|0.001
72422521|NCT02237508|144356015|EQUIVALENCE|"Z7200 was considered bioequivalent to the reference if the following criteria were satisfied:~* the 90%CI for the geometric mean AUC0-t ratio was within the interval 80.00% to 125.00% for both budesonide and formoterol, with and without charcoal blockade and~* the 90%CI for the geometric mean ratio for Cmax was within the wider bioequivalence acceptance limits of (69.84%, 143.19%) for budesonide and (71.92%, 139.04%) for formoterol, respectively with and without charcoal blockade."|Adjusted geometric means ratio|129.62|||<|0.001|TWO_SIDED|90.0|117.33|143.2|||Mixed Models Analysis|||||143.20|117.33|<0.001
72331094|NCT01942668|144188283|SUPERIORITY||Mean Difference (Final Values)|-8.33|STANDARD_ERROR_OF_MEAN|3.75||0.027|TWO_SIDED|95.0|-15.7|-0.96||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 6|Mixed Models Analysis||Adjusted for baseline using MMRM|||-0.96|-15.70|0.027
72331095|NCT01942668|144188283|SUPERIORITY||Mean Difference (Final Values)|-13.85|STANDARD_ERROR_OF_MEAN|3.71|<|0.001|TWO_SIDED|95.0|-21.13|-6.58||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 6|Mixed Models Analysis||Adjusted for baseline using MMRM|||-6.58|-21.13|<0.001
72331096|NCT01942668|144188284|SUPERIORITY||Mean Difference (Final Values)|-21.45|STANDARD_ERROR_OF_MEAN|3.78|<|0.001|TWO_SIDED|95.0|-28.87|-14.04||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 7|Mixed Models Analysis||Adjusted for baseline using MMRM|||-14.04|-28.87|<0.001
72331097|NCT01942668|144188284|SUPERIORITY||Mean Difference (Final Values)|-16.1|STANDARD_ERROR_OF_MEAN|3.71|<|0.001|TWO_SIDED|95.0|-23.39|-8.8||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 7|Mixed Models Analysis||Adjusted for baseline using MMRM|||-8.80|-23.39|<0.001
72331098|NCT01942668|144188284|SUPERIORITY||Mean Difference (Final Values)|-12.01|STANDARD_ERROR_OF_MEAN|3.73||0.001|TWO_SIDED|95.0|-19.34|-4.68||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 7|Mixed Models Analysis||Adjusted for baseline using MMRM|||-4.68|-19.34|0.001
72422522|NCT02237508|144356016|EQUIVALENCE|"Z7200 was considered bioequivalent to the reference if the following criteria were satisfied:~* the 90%CI for the geometric mean AUC0-t ratio was within the interval 80.00% to 125.00% for both budesonide and formoterol, with and without charcoal blockade and~* the 90%CI for the geometric mean ratio for Cmax was within the wider bioequivalence acceptance limits of (69.84%, 143.19%) for budesonide and (71.92%, 139.04%) for formoterol, respectively with and without charcoal blockade."|Adjusted geometric means ratio|218.13|||<|0.001|TWO_SIDED|90.0|194.02|245.24|||Mixed Models Analysis|||||245.24|194.02|<0.001
72553906|NCT05446870|144639909|OTHER||Posterior probability (%)|90.99|||||||||||||||Posterior probability (based on 20000 sets of model parameters) ctDNA fold change (square root scale) coefficient less than zero in the multivariable logistic regression model of CRS (CRS3 coded as 1 and CRS1 or 2 coded as 0), adjusted for baseline ctDNA and treatment assignment.|||
72331099|NCT01942668|144188284|SUPERIORITY||Mean Difference (Final Values)|-15.73|STANDARD_ERROR_OF_MEAN|3.69|<|0.001|TWO_SIDED|95.0|-22.97|-8.49||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 7|Mixed Models Analysis||Adjusted for baseline using MMRM|||-8.49|-22.97|<0.001
72331100|NCT01942668|144188285|SUPERIORITY||Mean Difference (Final Values)|-20.52|STANDARD_ERROR_OF_MEAN|3.84|<|0.001|TWO_SIDED|95.0|-28.06|-12.97||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 8|Mixed Models Analysis||Adjusted for baseline using MMRM|||-12.97|-28.06|<0.001
72331101|NCT01942668|144188285|SUPERIORITY||Mean Difference (Final Values)|-15.37|STANDARD_ERROR_OF_MEAN|3.78|<|0.001|TWO_SIDED|95.0|-22.8|-7.95||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 8|Mixed Models Analysis||Adjusted for baseline using MMRM|||-7.95|-22.80|<0.001
72331102|NCT01942668|144188285|SUPERIORITY||Mean Difference (Final Values)|-11.49|STANDARD_ERROR_OF_MEAN|3.8||0.003|TWO_SIDED|95.0|-18.95|-4.03||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 8|Mixed Models Analysis||Adjusted for baseline using MMRM|||-4.03|-18.95|0.003
72331103|NCT01942668|144188285|SUPERIORITY||Mean Difference (Final Values)|-13.82|STANDARD_ERROR_OF_MEAN|3.75|<|0.001|TWO_SIDED|95.0|-21.19|-6.46||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 8|Mixed Models Analysis||Adjusted for baseline using MMRM|||-6.46|-21.19|<0.001
72331104|NCT01942668|144188286|SUPERIORITY||Mean Difference (Final Values)|-20.34|STANDARD_ERROR_OF_MEAN|3.87|<|0.001|TWO_SIDED|95.0|-27.93|-12.74||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 9|Mixed Models Analysis||Adjusted for baseline using MMRM|||-12.74|-27.93|<0.001
72331105|NCT01942668|144188286|SUPERIORITY||Mean Difference (Final Values)|-17.92|STANDARD_ERROR_OF_MEAN|3.8|<|0.001|TWO_SIDED|95.0|-25.39|-10.45||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 9|Mixed Models Analysis||Adjusted for baseline using MMRM|||-10.45|-25.39|<0.001
72331106|NCT01942668|144188286|SUPERIORITY||Mean Difference (Final Values)|-12.97|STANDARD_ERROR_OF_MEAN|3.82|<|0.001|TWO_SIDED|95.0|-20.49|-5.46||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 9|Mixed Models Analysis||Adjusted for baseline using MMRM|||-5.46|-20.49|<0.001
72553907|NCT05446870|144639910|OTHER|Difference in percentage (calculated as % Pembrolizumab + SOC + MK-4830 arm - % Pembrolizumab + SOC arm) and 95% confidence interval (CI) were based on Miettinen \& Nurminen method.|Difference in Percentage|1.1|||||TWO_SIDED|95.0|-10.0|12.9||||||||12.9|-10.0|
72331107|NCT01942668|144188286|SUPERIORITY||Mean Difference (Final Values)|-14.28|STANDARD_ERROR_OF_MEAN|3.78|<|0.001|TWO_SIDED|95.0|-21.7|-6.87||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 9|Mixed Models Analysis||Adjusted for baseline using MMRM|||-6.87|-21.70|<0.001
72331108|NCT01942668|144188287|SUPERIORITY||Mean Difference (Final Values)|-21.01|STANDARD_ERROR_OF_MEAN|3.93|<|0.001|TWO_SIDED|95.0|-28.72|-13.29||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 10|Mixed Models Analysis||Adjusted for baseline using MMRM|||-13.29|-28.72|<0.001
72331109|NCT01942668|144188287|SUPERIORITY||Mean Difference (Final Values)|-18.37|STANDARD_ERROR_OF_MEAN|3.87|<|0.001|TWO_SIDED|95.0|-25.96|-10.78||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 10|Mixed Models Analysis||Adjusted for baseline using MMRM|||-10.78|-25.96|<0.001
72422523|NCT02237508|144356016|EQUIVALENCE|"Z7200 was considered bioequivalent to the reference if the following criteria were satisfied:~* the 90%CI for the geometric mean AUC0-t ratio was within the interval 80.00% to 125.00% for both budesonide and formoterol, with and without charcoal blockade and~* the 90%CI for the geometric mean ratio for Cmax was within the wider bioequivalence acceptance limits of (69.84%, 143.19%) for budesonide and (71.92%, 139.04%) for formoterol, respectively with and without charcoal blockade."|Adjusted geometric means ratio|200.66|||<|0.001|TWO_SIDED|90.0|174.3|231.01|||Mixed Models Analysis|||||231.01|174.30|<0.001
72331110|NCT01942668|144188287|SUPERIORITY||Mean Difference (Final Values)|-13.03|STANDARD_ERROR_OF_MEAN|3.89|<|0.001|TWO_SIDED|95.0|-20.66|-5.39||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 10|Mixed Models Analysis||Adjusted for baseline using MMRM|||-5.39|-20.66|<0.001
72331111|NCT01942668|144188287|SUPERIORITY||Mean Difference (Final Values)|-14.65|STANDARD_ERROR_OF_MEAN|3.84|<|0.001|TWO_SIDED|95.0|-22.19|-7.12||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 10|Mixed Models Analysis||Adjusted for baseline using MMRM|||-7.12|-22.19|<0.001
72331112|NCT01942668|144188288|SUPERIORITY||Mean Difference (Final Values)|-21.83|STANDARD_ERROR_OF_MEAN|3.94|<|0.001|TWO_SIDED|95.0|-29.57|-14.08||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 11|Mixed Models Analysis||Adjusted for baseline using MMRM|||-14.08|-29.57|<0.001
72331113|NCT01942668|144188288|SUPERIORITY||Mean Difference (Final Values)|-19.4|STANDARD_ERROR_OF_MEAN|3.88|<|0.001|TWO_SIDED|95.0|-27.02|-11.77||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 11|Mixed Models Analysis||Adjusted for baseline using MMRM|||-11.77|-27.02|<0.001
72331114|NCT01942668|144188288|SUPERIORITY||Mean Difference (Final Values)|-13.98|STANDARD_ERROR_OF_MEAN|3.9|<|0.001|TWO_SIDED|95.0|-21.65|-6.32||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 11|Mixed Models Analysis||Adjusted for baseline using MMRM|||-6.32|-21.65|<0.001
72331115|NCT01942668|144188288|SUPERIORITY||Mean Difference (Final Values)|-15.66|STANDARD_ERROR_OF_MEAN|3.85|<|0.001|TWO_SIDED|95.0|-23.23|-8.1||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 11|Mixed Models Analysis||Adjusted for baseline using MMRM|||-8.10|-23.23|<0.001
72331116|NCT01942668|144188289|SUPERIORITY||Mean Difference (Final Values)|-20.61|STANDARD_ERROR_OF_MEAN|3.93|<|0.001|TWO_SIDED|95.0|-28.32|-12.89||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis||Adjusted for baseline using MMRM|||-12.89|-28.32|<0.001
72331117|NCT01942668|144188289|SUPERIORITY||Mean Difference (Final Values)|-18.24|STANDARD_ERROR_OF_MEAN|3.87|<|0.001|TWO_SIDED|95.0|-25.84|-10.65||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis||Adjusted for baseline using MMRM|||-10.65|-25.84|<0.001
72331118|NCT01942668|144188289|SUPERIORITY||Mean Difference (Final Values)|-12.62|STANDARD_ERROR_OF_MEAN|3.89||0.001|TWO_SIDED|95.0|-20.26|-4.98||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis||Adjusted for baseline using MMRM|||-4.98|-20.26|0.001
72331119|NCT01942668|144188289|SUPERIORITY||Mean Difference (Final Values)|-13.97|STANDARD_ERROR_OF_MEAN|3.84|<|0.001|TWO_SIDED|95.0|-21.51|-6.43||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis||Adjusted for baseline using MMRM|||-6.43|-21.51|<0.001
72331120|NCT01942668|144188290|SUPERIORITY||Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.027||0.676|TWO_SIDED|95.0|-0.04|0.07||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 1|Mixed Models Analysis||Adjusted for baseline using MMRM|||0.07|-0.04|0.676
72331121|NCT01942668|144188290|SUPERIORITY||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.027||0.436|TWO_SIDED|95.0|-0.03|0.07||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 1|Mixed Models Analysis||Adjusted for baseline using MMRM|||0.07|-0.03|0.436
72331122|NCT01942668|144188290|SUPERIORITY||Mean Difference (Final Values)|0.04|STANDARD_ERROR_OF_MEAN|0.027||0.106|TWO_SIDED|95.0|-0.01|0.1||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 1|Mixed Models Analysis||Adjusted for baseline using MMRM|||0.10|-0.01|0.106
72331123|NCT01942668|144188290|SUPERIORITY||Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.027||0.752|TWO_SIDED|95.0|-0.06|0.04||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 1|Mixed Models Analysis||Adjusted for baseline using MMRM|||0.04|-0.06|0.752
72331124|NCT01942668|144188291|SUPERIORITY||Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.038||0.193|TWO_SIDED|95.0|-0.12|0.02||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 2|Mixed Models Analysis||Adjusted for baseline using MMRM|||0.02|-0.12|0.193
72331125|NCT01942668|144188291|SUPERIORITY||Mean Difference (Final Values)|-0.04|STANDARD_ERROR_OF_MEAN|0.037||0.319|TWO_SIDED|95.0|-0.11|0.04||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 2|Mixed Models Analysis||Adjusted for baseline using MMRM|||0.04|-0.11|0.319
72331126|NCT01942668|144188291|SUPERIORITY||Mean Difference (Final Values)|0.04|STANDARD_ERROR_OF_MEAN|0.037||0.239|TWO_SIDED|95.0|-0.03|0.12||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 2|Mixed Models Analysis||Adjusted for baseline using MMRM|||0.12|-0.03|0.239
72331127|NCT01942668|144188291|SUPERIORITY||Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.037||0.72|TWO_SIDED|95.0|-0.09|0.06||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 2|Mixed Models Analysis||Adjusted for baseline using MMRM|||0.06|-0.09|0.720
72331128|NCT01942668|144188292|SUPERIORITY||Mean Difference (Final Values)|-0.11|STANDARD_ERROR_OF_MEAN|0.049||0.03|TWO_SIDED|95.0|-0.2|-0.01||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 3|Mixed Models Analysis||Adjusted for baseline using MMRM|||-0.01|-0.20|0.030
72331129|NCT01942668|144188292|SUPERIORITY||Mean Difference (Final Values)|-0.09|STANDARD_ERROR_OF_MEAN|0.048||0.06|TWO_SIDED|95.0|-0.19|0.0||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 3|Mixed Models Analysis||Adjusted for baseline using MMRM|||0.00|-0.19|0.060
72331130|NCT01942668|144188292|SUPERIORITY||Mean Difference (Final Values)|0.03|STANDARD_ERROR_OF_MEAN|0.048||0.506|TWO_SIDED|95.0|-0.06|0.13||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 3|Mixed Models Analysis||Adjusted for baseline using MMRM|||0.13|-0.06|0.506
72331131|NCT01942668|144188292|SUPERIORITY||Mean Difference (Final Values)|-0.06|STANDARD_ERROR_OF_MEAN|0.048||0.232|TWO_SIDED|95.0|-0.15|0.04||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 3|Mixed Models Analysis||Adjusted for baseline using MMRM|||0.04|-0.15|0.232
72422524|NCT02237508|144356017|EQUIVALENCE|"Z7200 was considered bioequivalent to the reference if the following criteria were satisfied:~* the 90%CI for the geometric mean AUC0-t ratio was within the interval 80.00% to 125.00% for both budesonide and formoterol, with and without charcoal blockade and~* the 90%CI for the geometric mean ratio for Cmax was within the wider bioequivalence acceptance limits of (69.84%, 143.19%) for budesonide and (71.92%, 139.04%) for formoterol, respectively with and without charcoal blockade."|Adjusted geometric means ratio|126.17|||<|0.001|TWO_SIDED|90.0|115.93|137.32|||Mixed Models Analysis|||||137.32|115.93|<0.001
72422525|NCT02237508|144356017|EQUIVALENCE|"Z7200 was considered bioequivalent to the reference if the following criteria were satisfied:~* the 90%CI for the geometric mean AUC0-t ratio was within the interval 80.00% to 125.00% for both budesonide and formoterol, with and without charcoal blockade and~* the 90%CI for the geometric mean ratio for Cmax was within the wider bioequivalence acceptance limits of (69.84%, 143.19%) for budesonide and (71.92%, 139.04%) for formoterol, respectively with and without charcoal blockade."|Adjusted geometric means ratio|117.08||||0.004|TWO_SIDED|90.0|107.05|128.05|||Mixed Models Analysis|||||128.05|107.05|0.004
72422526|NCT01905046|144356066|SUPERIORITY||Odds Ratio (OR)|0.97||||0.951|TWO_SIDED|95.0|0.36|2.62|||Chi-squared|||||2.62|0.36|0.951
72422527|NCT03489057|144356079|SUPERIORITY|||||||0.19|||||||Mixed Models Analysis|||||||0.19
72331132|NCT01942668|144188293|SUPERIORITY||Mean Difference (Final Values)|-0.13|STANDARD_ERROR_OF_MEAN|0.058||0.027|TWO_SIDED|95.0|-0.24|-0.01||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 4|Mixed Models Analysis||Adjusted for baseline using MMRM|||-0.01|-0.24|0.027
72331133|NCT01942668|144188293|SUPERIORITY||Mean Difference (Final Values)|-0.15|STANDARD_ERROR_OF_MEAN|0.057||0.011|TWO_SIDED|95.0|-0.26|-0.03||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 4|Mixed Models Analysis||Adjusted for baseline using MMRM|||-0.03|-0.26|0.011
72331134|NCT01942668|144188293|SUPERIORITY||Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.057||0.71|TWO_SIDED|95.0|-0.13|0.09||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 4|Mixed Models Analysis||Adjusted for baseline using MMRM|||0.09|-0.13|0.710
72331135|NCT01942668|144188293|SUPERIORITY||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.057||0.072|TWO_SIDED|95.0|-0.21|0.01||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 4|Mixed Models Analysis||Adjusted for baseline using MMRM|||0.01|-0.21|0.072
72331136|NCT01942668|144188294|SUPERIORITY||Mean Difference (Final Values)|-0.23|STANDARD_ERROR_OF_MEAN|0.069|<|0.001|TWO_SIDED|95.0|-0.36|-0.09||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 5|Mixed Models Analysis||Adjusted for baseline using MMRM|||-0.09|-0.36|<0.001
72331137|NCT01942668|144188294|SUPERIORITY||Mean Difference (Final Values)|-0.13|STANDARD_ERROR_OF_MEAN|0.068||0.062|TWO_SIDED|95.0|-0.26|0.01||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 5|Mixed Models Analysis||Adjusted for baseline using MMRM|||0.01|-0.26|0.062
72331138|NCT01942668|144188294|SUPERIORITY||Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.068||0.886|TWO_SIDED|95.0|-0.12|0.14||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 5|Mixed Models Analysis||Adjusted for baseline using MMRM|||0.14|-0.12|0.886
72331139|NCT01942668|144188294|SUPERIORITY||Mean Difference (Final Values)|-0.12|STANDARD_ERROR_OF_MEAN|0.067||0.067|TWO_SIDED|95.0|-0.26|0.01||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 5|Mixed Models Analysis||Adjusted for baseline using MMRM|||0.01|-0.26|0.067
72331140|NCT01942668|144188295|SUPERIORITY||Mean Difference (Final Values)|-0.36|STANDARD_ERROR_OF_MEAN|0.084|<|0.001|TWO_SIDED|95.0|-0.53|-0.2||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 6|Mixed Models Analysis||Adjusted for baseline using MMRM|||-0.20|-0.53|<0.001
72422528|NCT03489057|144356093|SUPERIORITY|||||||0.48|||||||Mixed Models Analysis|||||||0.48
72422529|NCT01552954|144356110|SUPERIORITY_OR_OTHER|||||||0.006|TWO_SIDED|||||for albuminuria changes from week 8 at week 16 (week 8 - week 16)|t-test, 2 sided|||Differences with two-tailed P\<0.05 were considered statistically significant.||||0.006
72422530|NCT01552954|144356110|SUPERIORITY_OR_OTHER|||||||0.99|TWO_SIDED|||||for 24-hour urine albumin excretion between 8 weeks and 16 weeks|Mixed Models Analysis|||||||0.99
72422531|NCT01552954|144356110|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED|||||for 24-hour urine albumin excretion between 8 weeks and 16 weeks in intensive education group|Mixed Models Analysis|||||||0.001
72422532|NCT01552954|144356111|SUPERIORITY_OR_OTHER|||||||0.187|TWO_SIDED|||||for hemoglobin changes from week 0 at week 16 (week 0 - week 16)|t-test, 2 sided|||||||0.187
72422533|NCT01552954|144356112|SUPERIORITY_OR_OTHER|||||||0.001||||||for changes from week 8 at week 16 (week 8 - week 16)|t-test, 2 sided|||||||0.001
72422534|NCT01552954|144356113|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||for sBP changes from week 8 at week 16 (week 8 - week 16)|t-test, 2 sided|||||||>0.05
72422535|NCT01552954|144356113|SUPERIORITY_OR_OTHER|||||||0.585|TWO_SIDED|||||for dBP changes from week 8 at week 16 (week 8 - week 16)|t-test, 2 sided|||||||0.585
72422536|NCT04843930|144356114|SUPERIORITY||Mean Difference (Final Values)|0.12||||0.54|TWO_SIDED|||||Threshold for statistical significance: p \< 0.05. Exploratory efficacy analysis - p-value not adjusted for multiple comparisons.|Mixed Models Analysis|Degrees of freedom for the group x timepoint interaction: 3, 261.|Linear mixed effects interaction reported for group (intervention vs. waitlist control) and timepoint (all measures baseline to week 6).|"Linear Mixed Effects Model: main effects of arm group (intervention vs. waitlist control) and timepoint (all measures from baseline to week 6), arm group x timepoint interaction.~Modified intent-to-treat analysis with all participants who were randomized and completed at least the baseline study visit included in the analysis.~Participants in the intervention hypothesized to improve relative to waitlist control."||||0.54
72422537|NCT04843930|144356115|SUPERIORITY||Mean Difference (Final Values)|2.83||||0.04|TWO_SIDED|||||Threshold for statistical significance: p \< 0.05. Exploratory efficacy analysis - p-value not adjusted for multiple comparisons.|Mixed Models Analysis|Degrees of freedom for the group x timepoint interaction: 3, 239.|Linear mixed effects interaction reported for group (intervention vs. waitlist control) and timepoint (all measures baseline to week 6).|"Linear Mixed Effects Model: main effects of arm group (intervention vs. waitlist control) and timepoint (all measures from baseline to week 6), arm group x timepoint interaction.~Modified intent-to-treat analysis with all participants who were randomized and completed at least the baseline study visit included in the analysis."||||0.04
72422538|NCT04843930|144356116|SUPERIORITY||Mean Difference (Final Values)|0.07||||0.79|TWO_SIDED|||||Threshold for statistical significance: p \< 0.05. Exploratory efficacy analysis - p-value not adjusted for multiple comparisons.|Mixed Models Analysis|Degrees of freedom for the group x timepoint interaction: 3, 229.|Linear mixed effects interaction reported for group (intervention vs. waitlist control) and timepoint (all measures baseline to week 6).|"Linear Mixed Effects Model: main effects of arm group (intervention vs. waitlist control) and timepoint (all measures from baseline to week 6), arm group x timepoint interaction.~Modified intent-to-treat analysis with all participants who were randomized and completed at least the baseline study visit included in the analysis.~Participants in the intervention hypothesized to improve relative to waitlist control."||||0.79
72422539|NCT04843930|144356117|SUPERIORITY||Mean Difference (Final Values)|0.89||||0.45|TWO_SIDED|||||Threshold for statistical significance: p \< 0.05. Exploratory efficacy analysis - p-value not adjusted for multiple comparisons.|Mixed Models Analysis|Degrees of freedom for the group x timepoint interaction: 3, 269.|Linear mixed effects interaction reported for group (intervention vs. waitlist control) and timepoint (all measures baseline to week 6).|"Linear Mixed Effects Model: main effects of arm group (intervention vs. waitlist control) and timepoint (all measures from baseline to week 6), arm group x timepoint interaction.~Modified intent-to-treat analysis with all participants who were randomized and completed at least the baseline study visit included in the analysis.~Participants in the intervention hypothesized to improve relative to waitlist control."||||0.45
72422540|NCT04843930|144356118|SUPERIORITY||Mean Difference (Final Values)|5.0||||0.02|TWO_SIDED|||||Threshold for statistical significance: p \< 0.05. Exploratory efficacy analysis - p-value not adjusted for multiple comparisons.|Mixed Models Analysis|Degrees of freedom for the group x timepoint interaction: 3, 236.|Linear mixed effects interaction reported for group (intervention vs. waitlist control) and timepoint (all measures baseline to week 6).|"Linear Mixed Effects Model: main effects of arm group (intervention vs. waitlist control) and timepoint (all measures from baseline to week 6), arm group x timepoint interaction.~Modified intent-to-treat analysis with all participants who were randomized and completed at least the baseline study visit included in the analysis.~Participants in the intervention hypothesized to improve relative to waitlist control."||||0.02
72422541|NCT04843930|144356119|SUPERIORITY||Mean Difference (Final Values)|0.11||||0.96|TWO_SIDED|||||Threshold for statistical significance: p \< 0.05. Exploratory efficacy analysis - p-value not adjusted for multiple comparisons.|Mixed Models Analysis|Degrees of freedom for the group x timepoint interaction: 3, 257.|Linear mixed effects interaction reported for group (intervention vs. waitlist control) and timepoint (all measures baseline to week 6).|"Linear Mixed Effects Model: main effects of arm group (intervention vs. waitlist control) and timepoint (all measures from baseline to week 6), arm group x timepoint interaction.~Modified intent-to-treat analysis with all participants who were randomized and completed at least the baseline study visit included in the analysis.~Participants in the intervention hypothesized to improve relative to waitlist control."||||0.96
72553908|NCT05446870|144639911|OTHER|Difference in percentage (calculated as % Pembrolizumab + SOC + MK-4830 arm - % Pembrolizumab + SOC arm) and 95% CI were based on Miettinen \& Nurminen method.|Difference in Percentage|20.7|||||TWO_SIDED|95.0|3.5|37.0||||||||37.0|3.5|
72553909|NCT05446870|144639914|OTHER||Posterior probability (%)|38.75|||||||||||||||Posterior probability (based on 20000 sets of model parameters) coefficient for treatment assignment (MK-4830 containing vs. not) less than zero in Bayesian parametrization of the constrained longitudinal data analysis (cLDA) model, modeling ctDNA value at Cycle 3 and ctDNA value at baseline as bivariate normal.|||
72331141|NCT01942668|144188295|SUPERIORITY||Mean Difference (Final Values)|-0.16|STANDARD_ERROR_OF_MEAN|0.082||0.053|TWO_SIDED|95.0|-0.32|0.0||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 6|Mixed Models Analysis||Adjusted for baseline using MMRM|||0.00|-0.32|0.053
72331142|NCT01942668|144188295|SUPERIORITY||Mean Difference (Final Values)|-0.07|STANDARD_ERROR_OF_MEAN|0.083||0.413|TWO_SIDED|95.0|-0.23|0.09||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 6|Mixed Models Analysis||Adjusted for baseline using MMRM|||0.09|-0.23|0.413
72331143|NCT01942668|144188295|SUPERIORITY||Mean Difference (Final Values)|-0.19|STANDARD_ERROR_OF_MEAN|0.082||0.018|TWO_SIDED|95.0|-0.35|-0.03||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 6|Mixed Models Analysis||Adjusted for baseline using MMRM|||-0.03|-0.35|0.018
72331144|NCT01942668|144188296|SUPERIORITY||Mean Difference (Final Values)|-0.37|STANDARD_ERROR_OF_MEAN|0.085|<|0.001|TWO_SIDED|95.0|-0.54|-0.2||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 7|Mixed Models Analysis||Adjusted for baseline using MMRM|||-0.20|-0.54|<0.001
72422542|NCT04843930|144356120|SUPERIORITY||Mean Difference (Final Values)|2.78||||0.04|TWO_SIDED|||||Threshold for statistical significance: p \< 0.05. Exploratory efficacy analysis - p-value not adjusted for multiple comparisons.|Mixed Models Analysis|Degrees of freedom for the group x timepoint interaction: 3, 262.|Linear mixed effects interaction reported for group (intervention vs. waitlist control) and timepoint (all measures baseline to week 6).|"Linear Mixed Effects Model: main effects of arm group (intervention vs. waitlist control) and timepoint (all measures from baseline to week 6), arm group x timepoint interaction.~Modified intent-to-treat analysis with all participants who were randomized and completed at least the baseline study visit included in the analysis.~Participants in the intervention hypothesized to improve relative to waitlist control."||||0.04
72422543|NCT04843930|144356121|SUPERIORITY||Mean Difference (Final Values)|0.62||||0.6|TWO_SIDED|||||Threshold for statistical significance: p \< 0.05. Exploratory efficacy analysis - p-value not adjusted for multiple comparisons.|Mixed Models Analysis|Degrees of freedom for the group x timepoint interaction: 3, 227.|Linear mixed effects interaction reported for group (intervention vs. waitlist control) and timepoint (all measures baseline to week 6).|"Linear Mixed Effects Model: main effects of arm group (intervention vs. waitlist control) and timepoint (all measures from baseline to week 6), arm group x timepoint interaction.~Modified intent-to-treat analysis with all participants who were randomized and completed at least the baseline study visit included in the analysis.~Participants in the intervention hypothesized to improve relative to waitlist control."||||0.60
72422544|NCT04843930|144356122|SUPERIORITY||Mean Difference (Final Values)|3.77||||0.06|TWO_SIDED|||||Threshold for statistical significance: p \< 0.05. Exploratory efficacy analysis - p-value not adjusted for multiple comparisons.|Mixed Models Analysis|Degrees of freedom for the group x timepoint interaction: 1, 89.|Linear mixed effects interaction reported for group (intervention vs. waitlist control) and timepoint (all measures baseline to week 6).|"Linear Mixed Effects Model: main effects of arm group (intervention vs. waitlist control) and timepoint (all measures from baseline to week 6), arm group x timepoint interaction.~Modified intent-to-treat analysis with all participants who were randomized and completed at least the baseline study visit included in the analysis.~Participants in the intervention hypothesized to improve relative to waitlist control."||||0.06
72422545|NCT04843930|144356123|SUPERIORITY||Mean Difference (Final Values)|4.37||||0.04|TWO_SIDED|||||Threshold for statistical significance: p \< 0.05. Exploratory efficacy analysis - p-value not adjusted for multiple comparisons.|Mixed Models Analysis|Degrees of freedom for the group x timepoint interaction: 1, 73.|Linear mixed effects interaction reported for group (intervention vs. waitlist control) and timepoint (all measures baseline to week 6).|"Linear Mixed Effects Model: main effects of arm group (intervention vs. waitlist control) and timepoint (all measures from baseline to week 6), arm group x timepoint interaction.~Modified intent-to-treat analysis with all participants who were randomized and completed at least the baseline study visit included in the analysis.~Participants in the intervention hypothesized to improve relative to waitlist control."||||0.04
72422546|NCT00335257|144356124|NON_INFERIORITY_OR_EQUIVALENCE|Sample size calculations were based on a non-inferiority test of two exponential survival curves.These calculations are based on the following assumptions: 1) one-sided α 0.025; 2) power (1-β) of 0.90; 3) VTE incidence rate of 9/10.000 WY and 4) non-inferiority limit hazard ratio of 2. Furthermore, a study of this size would exclude a threefold risk of ATE.|Hazard Ratio (HR)|0.8|||||TWO_SIDED|95.0|0.5|1.3|||||Hazard ratio was adjusted for age, BMI, duration of current use, family history of VTE|Tested null hypotheses: the VTE hazard ratio for DRSP(24d) vs. Non-DRSP is higher or equal to 2||1.3|0.5|
72422547|NCT01576718|144356157|SUPERIORITY_OR_OTHER|||||||0.0604||||||If the Fp MDPI showed a significantly positive trend, then contrasts for pairwise comparisons of each Fp MDPI dose versus placebo were done in the sequence of highest to lowest Fp MDPI dose.|Regression, Linear|||A linear in log-dose trend contrast was constructed to evaluate the time-averaged dose-response trend, where the logarithm of dose was defined as log(dose+1) to accommodate the case of a zero dose (placebo). A fixed-sequence testing procedure was employed to control the overall Type I error rate at the 0.05 level. Specifically, the 2-sided linear in log-dose time-averaged trend test was first performed at the 0.05 level of significance.||||0.0604
72422548|NCT01576718|144356157|SUPERIORITY_OR_OTHER||LSM difference|0.072||||0.0637|TWO_SIDED|95.0|-0.004|0.149||Significance at the 0.05 level.|mixed model for repeated measures||Fp 400 - Placebo|No explicit structure was assumed for the covariance among the repeated measures. Analyses for comparison of Fp MDPI to placebo did not contain FLOVENT DISKUS data.||0.149|-0.004|0.0637
72422549|NCT01576718|144356157|SUPERIORITY_OR_OTHER||LSM difference|0.056||||0.1585|TWO_SIDED|95.0|-0.022|0.133||Significance at the 0.05 level|mixed model for repeated measures||Fp 200 - Placebo|No explicit structure was assumed for the covariance among the repeated measures. Analyses for comparison of Fp MDPI to placebo did not contain FLOVENT DISKUS data.||0.133|-0.022|0.1585
72331145|NCT01942668|144188296|SUPERIORITY||Mean Difference (Final Values)|-0.23|STANDARD_ERROR_OF_MEAN|0.083||0.006|TWO_SIDED|95.0|-0.4|-0.07||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 7|Mixed Models Analysis||Adjusted for baseline using MMRM|||-0.07|-0.40|0.006
72422550|NCT01576718|144356157|SUPERIORITY_OR_OTHER||LSM difference|0.048||||0.2221|TWO_SIDED|95.0|-0.029|0.124||Significance at the 0.05 level|mixed model for repeated measures||Fp 100 - Placebo|No explicit structure was assumed for the covariance among the repeated measures. Analyses for comparison of Fp MDPI to placebo did not contain FLOVENT DISKUS data.||0.124|-0.029|0.2221
72331146|NCT01942668|144188296|SUPERIORITY||Mean Difference (Final Values)|-0.15|STANDARD_ERROR_OF_MEAN|0.084||0.072|TWO_SIDED|95.0|-0.32|0.01||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 7|Mixed Models Analysis||Adjusted for baseline using MMRM|||0.01|-0.32|0.072
72331147|NCT01942668|144188296|SUPERIORITY||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.083||0.014|TWO_SIDED|95.0|-0.37|-0.04||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 7|Mixed Models Analysis||Adjusted for baseline using MMRM|||-0.04|-0.37|0.014
72331148|NCT01942668|144188297|SUPERIORITY||Mean Difference (Final Values)|-0.38|STANDARD_ERROR_OF_MEAN|0.087|<|0.001|TWO_SIDED|95.0|-0.55|-0.21||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 8|Mixed Models Analysis||Adjusted for baseline using MMRM|||-0.21|-0.55|<0.001
72331149|NCT01942668|144188297|SUPERIORITY||Mean Difference (Final Values)|-0.21|STANDARD_ERROR_OF_MEAN|0.085||0.016|TWO_SIDED|95.0|-0.37|-0.04||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 8|Mixed Models Analysis||Adjusted for baseline using MMRM|||-0.04|-0.37|0.016
72331150|NCT01942668|144188297|SUPERIORITY||Mean Difference (Final Values)|-0.12|STANDARD_ERROR_OF_MEAN|0.086||0.169|TWO_SIDED|95.0|-0.29|0.05||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 8|Mixed Models Analysis||Adjusted for baseline using MMRM|||0.05|-0.29|0.169
72331151|NCT01942668|144188297|SUPERIORITY||Mean Difference (Final Values)|-0.15|STANDARD_ERROR_OF_MEAN|0.085||0.081|TWO_SIDED|95.0|-0.31|0.02||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 8|Mixed Models Analysis||Adjusted for baseline using MMRM|||0.02|-0.31|0.081
72331152|NCT01942668|144188298|SUPERIORITY||Mean Difference (Final Values)|-0.48|STANDARD_ERROR_OF_MEAN|0.092|<|0.001|TWO_SIDED|95.0|-0.66|-0.3||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 9|Mixed Models Analysis||Adjusted for baseline using MMRM|||-0.30|-0.66|<0.001
72331153|NCT01942668|144188298|SUPERIORITY||Mean Difference (Final Values)|-0.27|STANDARD_ERROR_OF_MEAN|0.091||0.003|TWO_SIDED|95.0|-0.45|-0.1||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 9|Mixed Models Analysis||Adjusted for baseline using MMRM|||-0.10|-0.45|0.003
72331154|NCT01942668|144188298|SUPERIORITY||Mean Difference (Final Values)|-0.21|STANDARD_ERROR_OF_MEAN|0.091||0.022|TWO_SIDED|95.0|-0.39|-0.03||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 9|Mixed Models Analysis||Adjusted for baseline using MMRM|||-0.03|-0.39|0.022
72331155|NCT01942668|144188298|SUPERIORITY||Mean Difference (Final Values)|-0.25|STANDARD_ERROR_OF_MEAN|0.09||0.006|TWO_SIDED|95.0|-0.43|-0.07||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 9|Mixed Models Analysis||Adjusted for baseline using MMRM|||-0.07|-0.43|0.006
72331156|NCT01942668|144188299|SUPERIORITY||Mean Difference (Final Values)|-0.52|STANDARD_ERROR_OF_MEAN|0.096|<|0.001|TWO_SIDED|95.0|-0.71|-0.33||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 10|Mixed Models Analysis||Adjusted for baseline using MMRM|||-0.33|-0.71|<0.001
72422551|NCT01576718|144356157|SUPERIORITY_OR_OTHER||LSM difference|0.006|||=|0.8694|TWO_SIDED|95.0|-0.07|0.083||Significance at the 0.05 level|mixed model for repeated measures||Fp 50 - Placebo|No explicit structure was assumed for the covariance among the repeated measures. Analyses for comparison of Fp MDPI to placebo did not contain FLOVENT DISKUS data.||0.083|-0.070|=0.8694
72331157|NCT01942668|144188299|SUPERIORITY||Mean Difference (Final Values)|-0.26|STANDARD_ERROR_OF_MEAN|0.095||0.007|TWO_SIDED|95.0|-0.44|-0.07||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 10|Mixed Models Analysis||Adjusted for baseline using MMRM|||-0.07|-0.44|0.007
72331158|NCT01942668|144188299|SUPERIORITY||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.095||0.038|TWO_SIDED|95.0|-0.39|-0.01||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 10|Mixed Models Analysis||Adjusted for baseline using MMRM|||-0.01|-0.39|0.038
72331159|NCT01942668|144188299|SUPERIORITY||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.094||0.283|TWO_SIDED|95.0|-0.29|0.08||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 10|Mixed Models Analysis||Adjusted for baseline using MMRM|||0.08|-0.29|0.283
72331160|NCT01942668|144188300|SUPERIORITY||Mean Difference (Final Values)|-0.53|STANDARD_ERROR_OF_MEAN|0.099|<|0.001|TWO_SIDED|95.0|-0.72|-0.34||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 11|Mixed Models Analysis||Adjusted for baseline using MMRM|||-0.34|-0.72|<0.001
72331161|NCT01942668|144188300|SUPERIORITY||Mean Difference (Final Values)|-0.35|STANDARD_ERROR_OF_MEAN|0.097|<|0.001|TWO_SIDED|95.0|-0.54|-0.16||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 11|Mixed Models Analysis||Adjusted for baseline using MMRM|||-0.16|-0.54|<0.001
72331162|NCT01942668|144188300|SUPERIORITY||Mean Difference (Final Values)|-0.22|STANDARD_ERROR_OF_MEAN|0.098||0.027|TWO_SIDED|95.0|-0.41|-0.02||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 11|Mixed Models Analysis||Adjusted for baseline using MMRM|||-0.02|-0.41|0.027
72331163|NCT01942668|144188300|SUPERIORITY||Mean Difference (Final Values)|-0.17|STANDARD_ERROR_OF_MEAN|0.096||0.071|TWO_SIDED|95.0|-0.36|0.01||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 11|Mixed Models Analysis||Adjusted for baseline using MMRM|||0.01|-0.36|0.071
72553910|NCT02446600|144639922|SUPERIORITY||Hazard Ratio (HR)|0.856||||0.077|TWO_SIDED|95.0|0.663|1.105||The p-value is one-sided. Per the protocol, the statistical significance threshold was \<0.025. Type 1 error was controlled using hierarchical testing strategy.|Log Rank|The log rank test was stratified by the minimization factors provided at randomization|The hazard ratio estimate compares olaparib+cedirinib to chemotherapy. If olaparib+cedirinib is superior, the hazard ratio is \<1.0.|Arm II was suspended for futility at the interim analysis so was not analyzed at the final analysis.||1.105|0.663|0.077
72331164|NCT01942668|144188301|SUPERIORITY||Mean Difference (Final Values)|-0.57|STANDARD_ERROR_OF_MEAN|0.101|<|0.001|TWO_SIDED|95.0|-0.77|-0.37||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis||Adjusted for baseline using MMRM|||-0.37|-0.77|<0.001
72422552|NCT01576718|144356158|SUPERIORITY_OR_OTHER|||||||0.1512||||||If the Fp MDPI showed a significantly positive trend, then contrasts for pairwise comparisons of each Fp MDPI dose versus placebo were done in the sequence of highest to lowest Fp MDPI dose.|Regression, Linear|||A linear in log-dose trend contrast was constructed to evaluate the time-averaged dose-response trend, where the logarithm of dose was defined as log(dose+1) to accommodate the case of a zero dose (placebo). A fixed-sequence testing procedure was employed to control the overall Type I error rate at the 0.05 level. Specifically, the 2-sided linear in log-dose time-averaged trend test was first performed at the 0.05 level of significance.||||0.1512
72553911|NCT04608188|144639935|SUPERIORITY|||||||0.05|||||||Mixed Models Analysis|||||||0.05
72422553|NCT01576718|144356158|SUPERIORITY_OR_OTHER||LSM difference|7.36||||0.2361|TWO_SIDED|95.0|-4.83|19.56||Significance at the 0.05 level|Regression, Linear|||No explicit structure was assumed for the covariance among the repeated measures. Analyses for comparison of Fp MDPI to placebo did not contain FLOVENT DISKUS data.||19.56|-4.83|0.2361
72422554|NCT01576718|144356158|SUPERIORITY_OR_OTHER||LSM difference|7.78||||0.2169|TWO_SIDED|95.0|-4.59|20.15|||Regression, Linear|Significance at the 0.05 level||No explicit structure was assumed for the covariance among the repeated measures. Analyses for comparison of Fp MDPI to placebo did not contain FLOVENT DISKUS data.||20.15|-4.59|0.2169
72422555|NCT01576718|144356158|SUPERIORITY_OR_OTHER||LSM difference|7.09||||0.2523|TWO_SIDED|95.0|-5.07|19.26||Significance at the 0.05 level|Regression, Linear|||No explicit structure was assumed for the covariance among the repeated measures. Analyses for comparison of Fp MDPI to placebo did not contain FLOVENT DISKUS data.||19.26|-5.07|0.2523
72422556|NCT01576718|144356158|SUPERIORITY_OR_OTHER||LSM difference|8.23||||0.1858|TWO_SIDED|95.0|-3.98|20.45||Significance at the 0.05 level|Regression, Linear|||No explicit structure was assumed for the covariance among the repeated measures. Analyses for comparison of Fp MDPI to placebo did not contain FLOVENT DISKUS data.||20.45|-3.98|0.1858
72331165|NCT01942668|144188301|SUPERIORITY||Mean Difference (Final Values)|-0.37|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.57|-0.18||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis||Adjusted for baseline using MMRM|||-0.18|-0.57|<0.001
72553912|NCT04608188|144639936|SUPERIORITY|||||||0.05|||||||Mixed Models Analysis|||||||0.05
72331166|NCT01942668|144188301|SUPERIORITY||Mean Difference (Final Values)|-0.21|STANDARD_ERROR_OF_MEAN|0.1||0.039|TWO_SIDED|95.0|-0.4|-0.01||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis||Adjusted for baseline using MMRM|||-0.01|-0.40|0.039
72331167|NCT01942668|144188301|SUPERIORITY||Mean Difference (Final Values)|-0.17|STANDARD_ERROR_OF_MEAN|0.099||0.088|TWO_SIDED|95.0|-0.36|0.03||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis||Adjusted for baseline using MMRM|||0.03|-0.36|0.088
72331168|NCT01942668|144188302|SUPERIORITY|||||||0.85||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 1|Fisher Exact|||\>=50% Reduction||||0.850
72331169|NCT01942668|144188302|SUPERIORITY|||||||0.622||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 1|Fisher Exact|||\>=75% Reduction||||0.622
72331170|NCT01942668|144188302|SUPERIORITY|||||||1||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 1|Fisher Exact|||\>=50% Reduction||||1.000
72331171|NCT01942668|144188302|SUPERIORITY|||||||0.374||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 1|Fisher Exact|||\>=75% Reduction||||0.374
72553913|NCT04608188|144639937|SUPERIORITY|||||||0.05|||||||Mixed Models Analysis|||||||0.05
72553914|NCT04608188|144639938|SUPERIORITY|||||||0.05|||||||Mixed Models Analysis|||||||0.05
72331172|NCT01942668|144188302|SUPERIORITY|||||||0.706||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 1|Fisher Exact|||\>=50% Reduction||||0.706
72331173|NCT01942668|144188302|SUPERIORITY|||||||0.372||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 1|Fisher Exact|||\>=75% Reduction||||0.372
72331174|NCT01942668|144188302|SUPERIORITY|||||||0.316||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 1|Fisher Exact|||\>=50% Reduction||||0.316
72331175|NCT01942668|144188302|SUPERIORITY|||||||0.221||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 1|Fisher Exact|||\>=75% Reduction||||0.221
72331176|NCT01942668|144188303|SUPERIORITY|||||||0.283||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 2|Fisher Exact|||\>=50% Reduction||||0.283
72331177|NCT01942668|144188303|SUPERIORITY|||||||0.004||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 2|Fisher Exact|||\>=75% Reduction||||0.004
72331178|NCT01942668|144188303|SUPERIORITY|||||||0.68||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 2|Fisher Exact|||\>=50% Reduction||||0.680
72331179|NCT01942668|144188303|SUPERIORITY|||||||0.232||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 2|Fisher Exact|||\>=75% Reduction||||0.232
72331180|NCT01942668|144188303|SUPERIORITY|||||||0.677||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 2|Fisher Exact|||\>=50% Reduction||||0.677
72331181|NCT01942668|144188303|SUPERIORITY|||||||0.073||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 2|Fisher Exact|||\>=75% Reduction||||0.073
72331182|NCT01942668|144188303|SUPERIORITY|||||||0.301||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 2|Fisher Exact|||\>=50% Reduction||||0.301
72331183|NCT01942668|144188303|SUPERIORITY|||||||0.013||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 2|Fisher Exact|||\>=75% Reduction||||0.013
72331184|NCT01942668|144188304|SUPERIORITY|||||||0.003||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 3|Fisher Exact|||\>=50% Reduction||||0.003
72331185|NCT01942668|144188304|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 3|Fisher Exact|||\>=75% Reduction||||<0.001
72331186|NCT01942668|144188304|SUPERIORITY|||||||0.135||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 3|Fisher Exact|||\>=50% Reduction||||0.135
72331187|NCT01942668|144188304|SUPERIORITY|||||||0.231||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 3|Fisher Exact|||\>=75% Reduction||||0.231
72331188|NCT01942668|144188304|SUPERIORITY|||||||0.377||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 3|Fisher Exact|||\>=50% Reduction||||0.377
72331189|NCT01942668|144188304|SUPERIORITY|||||||0.478||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 3|Fisher Exact|||\>=75% Reduction||||0.478
72331190|NCT01942668|144188304|SUPERIORITY|||||||0.015||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 3|Fisher Exact|||\>=50% Reduction||||0.015
72331191|NCT01942668|144188304|SUPERIORITY|||||||0.1||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 3|Fisher Exact|||\>=75% Reduction||||0.100
72331192|NCT01942668|144188305|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 4|Fisher Exact|||\>=50% Reduction||||<0.001
72331193|NCT01942668|144188305|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 4|Fisher Exact|||\>=75% Reduction||||<0.001
72331194|NCT01942668|144188305|SUPERIORITY|||||||0.009||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 4|Fisher Exact|||\>=50% Reduction||||0.009
72331195|NCT01942668|144188305|SUPERIORITY|||||||0.017||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 4|Fisher Exact|||\>=75% Reduction||||0.017
72331196|NCT01942668|144188305|SUPERIORITY|||||||0.001||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 4|Fisher Exact|||||||0.001
72331197|NCT01942668|144188305|SUPERIORITY|||||||0.025||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 4|Fisher Exact|||\>=75% Reduction||||0.025
72331198|NCT01942668|144188305|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 4|Fisher Exact|||\>=50% Reduction||||<0.001
72331199|NCT01942668|144188305|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 4|Fisher Exact|||\>=75% Reduction||||<0.001
72422557|NCT01576718|144356159|SUPERIORITY_OR_OTHER|||||||0.2879||||||If the Fp MDPI showed a significantly positive trend, then contrasts for pairwise comparisons of each Fp MDPI dose versus placebo were done in the sequence of highest to lowest Fp MDPI dose.|Regression, Linear|||A linear in log-dose trend contrast was constructed to evaluate the time-averaged dose-response trend, where the logarithm of dose was defined as log(dose+1) to accommodate the case of a zero dose (placebo). A fixed-sequence testing procedure was employed to control the overall Type I error rate at the 0.05 level. Specifically, the 2-sided linear in log-dose time-averaged trend test was first performed at the 0.05 level of significance.||||0.2879
72422558|NCT01576718|144356159|SUPERIORITY_OR_OTHER||LSM difference|7.56||||0.2166|TWO_SIDED|95.0|-4.45|19.56||Significance at the 0.05 level|Regression, Linear|||No explicit structure was assumed for the covariance among the repeated measures. Analyses for comparison of Fp MDPI to placebo did not contain FLOVENT DISKUS data.||19.56|-4.45|0.2166
72422559|NCT01576718|144356159|SUPERIORITY_OR_OTHER||LSM difference|4.03||||0.5167|TWO_SIDED|95.0|-8.17|16.23||Significance at the 0.05 level|Regression, Linear|||No explicit structure was assumed for the covariance among the repeated measures. Analyses for comparison of Fp MDPI to placebo did not contain FLOVENT DISKUS data.||16.23|-8.17|0.5167
72422560|NCT01576718|144356159|SUPERIORITY_OR_OTHER||LSM difference|2.99||||0.6258|TWO_SIDED|95.0|-9.06|15.05||Significance at the 0.05 level|Regression, Linear|||No explicit structure was assumed for the covariance among the repeated measures. Analyses for comparison of Fp MDPI to placebo did not contain FLOVENT DISKUS data.||15.05|-9.06|0.6258
72422561|NCT01576718|144356159|SUPERIORITY_OR_OTHER||LSM difference|0.39||||0.9487|TWO_SIDED|95.0|-11.6|12.39||Significance at the 0.05 level|Regression, Linear|||No explicit structure was assumed for the covariance among the repeated measures. Analyses for comparison of Fp MDPI to placebo did not contain FLOVENT DISKUS data.||12.39|-11.60|0.9487
72422562|NCT01576718|144356160|SUPERIORITY_OR_OTHER|||||||0.0341||||||Significance level of 0.05.|Log Rank|||P-value for comparison of survival curve to placebo||||0.0341
72331200|NCT01942668|144188306|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 5|Fisher Exact|||\>=50% Reduction||||<0.001
72331201|NCT01942668|144188306|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 5|Fisher Exact|||\>=75% Reduction||||<0.001
72422563|NCT01576718|144356160|SUPERIORITY_OR_OTHER|||||||0.034||||||Significance level of 0.05.|Log Rank|||P-value for comparison of survival curve to placebo||||0.0340
72422564|NCT01576718|144356160|SUPERIORITY_OR_OTHER|||||||0.0058||||||Significance level of 0.05.|Log Rank|||P-value for comparison of survival curve to placebo||||0.0058
72422565|NCT01576718|144356160|SUPERIORITY_OR_OTHER|||||||0.0018||||||Significance level of 0.05.|Log Rank|||P-value for comparison of survival curve to placebo||||0.0018
72422566|NCT01576718|144356160|SUPERIORITY_OR_OTHER|||||||0.1006||||||Significance level of 0.05.|Log Rank|||P-value for comparison of survival curve to placebo||||0.1006
72422567|NCT01576718|144356161|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.9||||0.88116|TWO_SIDED|95.0|-11.12|12.91||Significance at the 0.05 level|Regression, Linear|||Estimates computed from a generalized linear logistic model with gender and age as covariates and allows correlation between estimates on the same subject. Interpretation of the estimates is that they are the average over the population at the average level of continuous covariate (age) averaged over discrete covariate (gender).||12.91|-11.12|0.88116
72422568|NCT01576718|144356161|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.98||||0.05977|TWO_SIDED|95.0|-22.64|0.68||Significance at the 0.05 level|Regression, Linear|||Estimates computed from a generalized linear logistic model with gender and age as covariates and allows correlation between estimates on the same subject. Interpretation of the estimates is that they are the average over the population at the average level of continuous covariate (age) averaged over discrete covariate (gender).||0.68|-22.64|0.05977
72331202|NCT01942668|144188306|SUPERIORITY|||||||0.066||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 5|Fisher Exact|||\>=50% Reduction||||0.066
72331203|NCT01942668|144188306|SUPERIORITY|||||||0.055||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 5|Fisher Exact|||\>=75% Reduction||||0.055
72331204|NCT01942668|144188306|SUPERIORITY|||||||0.174||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 5|Fisher Exact|||\>=50% Reduction||||0.174
72331205|NCT01942668|144188306|SUPERIORITY|||||||0.319||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 5|Fisher Exact|||\>=75% Reduction||||0.319
72331206|NCT01942668|144188306|SUPERIORITY|||||||0.007||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 5|Fisher Exact|||\>=50% Reduction||||0.007
72331207|NCT01942668|144188306|SUPERIORITY|||||||0.008||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 5|Fisher Exact|||\>=75% Reduction||||0.008
72331208|NCT01942668|144188307|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 6|Fisher Exact|||\>=50% Reduction||||<0.001
72331209|NCT01942668|144188307|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 6|Fisher Exact|||\>=75% Reduction||||<0.001
72331210|NCT01942668|144188307|SUPERIORITY|||||||0.019||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 6|Fisher Exact|||\>=50% Reduction||||0.019
72331211|NCT01942668|144188307|SUPERIORITY|||||||0.061||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 6|Fisher Exact|||\>=75% Reduction||||0.061
72331212|NCT01942668|144188307|SUPERIORITY|||||||0.026||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 6|Fisher Exact|||\>=50% Reduction||||0.026
72331213|NCT01942668|144188307|SUPERIORITY|||||||0.104||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 6|Fisher Exact|||\>=75% Reduction||||0.104
72331214|NCT01942668|144188307|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 6|Fisher Exact|||\>=50% Reduction||||<0.001
72331215|NCT01942668|144188307|SUPERIORITY|||||||0.018||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 6|Fisher Exact|||\>=75% Reduction||||0.018
72331216|NCT01942668|144188308|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 7|Fisher Exact|||\>=50% Reduction||||<0.001
72331217|NCT01942668|144188308|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 7|Fisher Exact|||\>=75% Reduction||||<0.001
72331218|NCT01942668|144188308|SUPERIORITY|||||||0.006||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 7|Fisher Exact|||\>=50% Reduction||||0.006
72331219|NCT01942668|144188308|SUPERIORITY|||||||0.003||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 7|Fisher Exact|||\>=75% Reduction||||0.003
72331220|NCT01942668|144188308|SUPERIORITY|||||||0.017||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 7|Fisher Exact|||\>=50% Reduction||||0.017
72331221|NCT01942668|144188308|SUPERIORITY|||||||0.025||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 7|Fisher Exact|||\>=75% Reduction||||0.025
72331222|NCT01942668|144188308|SUPERIORITY|||||||0.001||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 7|Fisher Exact|||\>=50% Reduction||||0.001
72331223|NCT01942668|144188308|SUPERIORITY|||||||0.037||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 7|Fisher Exact|||\>=75% Reduction||||0.037
72331224|NCT01942668|144188309|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 8|Fisher Exact|||\>=50% Reduction||||<0.001
72331225|NCT01942668|144188309|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 8|Fisher Exact|||\>=75% Reduction||||<0.001
72331226|NCT01942668|144188309|SUPERIORITY|||||||0.001||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 8|Fisher Exact|||\>=50% Reduction||||0.001
72331227|NCT01942668|144188309|SUPERIORITY|||||||0.016||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 8|Fisher Exact|||\>=75% Reduction||||0.016
72331228|NCT01942668|144188309|SUPERIORITY|||||||0.012||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 8|Fisher Exact|||\>=50% Reduction||||0.012
72331229|NCT01942668|144188309|SUPERIORITY|||||||0.053||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 8|Fisher Exact|||\>=75% Reduction||||0.053
72331230|NCT01942668|144188309|SUPERIORITY|||||||0.004||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 8|Fisher Exact|||\>=50% Reduction||||0.004
72331231|NCT01942668|144188309|SUPERIORITY|||||||0.074||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 8|Fisher Exact|||\>=75% Reduction||||0.074
72331232|NCT01942668|144188310|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 9|Fisher Exact|||\>=50% Reduction||||<0.001
72331233|NCT01942668|144188310|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 9|Fisher Exact|||\>=75% Reduction||||<0.001
72331234|NCT01942668|144188310|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 9|Fisher Exact|||\>=50% Reduction||||<0.001
72331235|NCT01942668|144188310|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 9|Fisher Exact|||\>=75% Reduction||||<0.001
72422569|NCT01576718|144356161|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.74||||0.90426|TWO_SIDED|95.0|-13.02|11.54||Significance at the 0.05 level|Regression, Linear|||Estimates computed from a generalized linear logistic model with gender and age as covariates and allows correlation between estimates on the same subject. Interpretation of the estimates is that they are the average over the population at the average level of continuous covariate (age) averaged over discrete covariate (gender).||11.54|-13.02|0.90426
72331236|NCT01942668|144188310|SUPERIORITY|||||||0.009||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 9|Fisher Exact|||\>=50% Reduction||||0.009
72331237|NCT01942668|144188310|SUPERIORITY|||||||0.004||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 9|Fisher Exact|||\>=75% Reduction||||0.004
72331238|NCT01942668|144188310|SUPERIORITY|||||||0.002||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 9|Fisher Exact|||\>=50% Reduction||||0.002
72331239|NCT01942668|144188310|SUPERIORITY|||||||0.015||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 9|Fisher Exact|||\>=75% Reduction||||0.015
72331240|NCT01942668|144188311|SUPERIORITY|||||||0.004||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 10|Fisher Exact|||\>=50% Reduction||||0.004
72553915|NCT00838136|144639939|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|101.23||||||90.0|99.88|102.6|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||102.60|99.88|
72331241|NCT01942668|144188311|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 10|Fisher Exact|||\>=75% Reduction||||<0.001
72331242|NCT01942668|144188311|SUPERIORITY|||||||0.002||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 10|Fisher Exact|||\>=50% Reduction||||0.002
72331243|NCT01942668|144188311|SUPERIORITY|||||||0.001||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 10|Fisher Exact|||\>=75% Reduction||||0.001
72331244|NCT01942668|144188311|SUPERIORITY|||||||0.001||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 10|Fisher Exact|||\>=50% Reduction||||0.001
72331245|NCT01942668|144188311|SUPERIORITY|||||||0.009||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 10|Fisher Exact|||\>=75% Reduction||||0.009
72331246|NCT01942668|144188311|SUPERIORITY|||||||0.018||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 10|Fisher Exact|||\>=50% Reduction||||0.018
72331247|NCT01942668|144188311|SUPERIORITY|||||||0.021||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 10|Fisher Exact|||\>=75% Reduction||||0.021
72331248|NCT01942668|144188312|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 11|Fisher Exact|||\>=50% Reduction||||<0.001
72331249|NCT01942668|144188312|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 11|Fisher Exact|||\>=75% Reduction||||<0.001
72331250|NCT01942668|144188312|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 11|Fisher Exact|||\>=50% Reduction||||<0.001
72331251|NCT01942668|144188312|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 11|Fisher Exact|||\>=75% Reduction||||<0.001
72331252|NCT01942668|144188312|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 11|Fisher Exact|||\>=50% Reduction||||<0.001
72331253|NCT01942668|144188312|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 11|Fisher Exact|||\>=75% Reduction||||<0.001
72331254|NCT01942668|144188312|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 11|Fisher Exact|||\>=50% Reduction||||<0.001
72331255|NCT01942668|144188312|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 11|Fisher Exact|||\>=75% Reduction||||<0.001
72331256|NCT01942668|144188313|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 12|Fisher Exact|||\>=50% Reduction||||<0.001
72331257|NCT01942668|144188313|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 12|Fisher Exact|||\>=75% Reduction||||<0.001
72331258|NCT01942668|144188313|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 12|Fisher Exact|||\>=50% Reduction||||<0.001
72331259|NCT01942668|144188313|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 12|Fisher Exact|||\>=75% Reduction||||<0.001
72331260|NCT01942668|144188313|SUPERIORITY|||||||0.006||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 12|Fisher Exact|||\>=50% Reduction||||0.006
72422570|NCT01576718|144356161|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.38||||0.4731|TWO_SIDED|95.0|-16.57|7.82||Significance at the 0.05 level|Regression, Linear|||Estimates computed from a generalized linear logistic model with gender and age as covariates and allows correlation between estimates on the same subject. Interpretation of the estimates is that they are the average over the population at the average level of continuous covariate (age) averaged over discrete covariate (gender).||7.82|-16.57|0.47310
72422571|NCT01576718|144356168|SUPERIORITY_OR_OTHER||LSM difference|0.019|||=|0.6161|TWO_SIDED|95.0|-0.057|0.096||0.05 level of significance.|mixed model for repeated measures|||||0.096|-0.057|=0.6161
72422572|NCT01576718|144356168|SUPERIORITY_OR_OTHER||LSM difference|0.004||||0.9245|TWO_SIDED|95.0|-0.973|0.08||0.05 level of significance.|mixed model for repeated measures|||||0.080|-0.973|0.9245
72422573|NCT01576718|144356168|SUPERIORITY_OR_OTHER||LSM difference|-0.008||||0.8434|TWO_SIDED|95.0|-0.083|0.068||0.05 level of significance.|mixed model for repeated measures|||||0.068|-0.083|0.8434
72422574|NCT01576718|144356168|SUPERIORITY_OR_OTHER||LSM difference|-0.047||||0.2241|TWO_SIDED|95.0|-0.122|0.029||0.05 level of significance.|mixed model for repeated measures|||||0.029|-0.122|0.2241
72422575|NCT01576718|144356168|SUPERIORITY_OR_OTHER||LSM difference|-0.053||||0.1822|TWO_SIDED|95.0|-0.13|0.025||0.05 level of significance.|mixed model for repeated measures|||||0.025|-0.130|0.1822
72422576|NCT01576718|144356169|SUPERIORITY_OR_OTHER||LSM difference|-5.56||||0.3568|TWO_SIDED|95.0|-17.42|6.29||0.05 level of significance.|Regression, Linear|||||6.29|-17.42|0.3568
72422577|NCT01576718|144356169|SUPERIORITY_OR_OTHER||LSM difference|-5.68||||0.3531|TWO_SIDED|95.0|-17.67|6.32||0.05 level of significance.|Regression, Linear|||||6.32|-17.67|0.3531
72331261|NCT01942668|144188313|SUPERIORITY|||||||0.001||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 12|Fisher Exact|||\>=75% Reduction||||0.001
72422578|NCT01576718|144356169|SUPERIORITY_OR_OTHER||LSM difference|-6.58||||0.2724|TWO_SIDED|95.0|-18.35|5.19||0.05 level of significance.|Regression, Linear|||||5.19|-18.35|0.2724
72422579|NCT01576718|144356169|SUPERIORITY_OR_OTHER||LSM difference|-5.11|||=|0.3964|TWO_SIDED|95.0|-16.95|6.72||0.05 level of significance.|Regression, Linear|||||6.72|-16.95|=0.3964
72422580|NCT01576718|144356169|SUPERIORITY_OR_OTHER||LSM difference|-13.45||||0.0296|TWO_SIDED|95.0|-25.57|-1.33||0.05 level of significance.|Regression, Linear|||||-1.33|-25.57|0.0296
72422581|NCT01576718|144356170|SUPERIORITY_OR_OTHER||LSM difference|-0.69||||0.9101|TWO_SIDED|95.0|-12.59|11.22||0.05 level of significance.|Regression, Linear|||||11.22|-12.59|0.9101
72422582|NCT01576718|144356170|SUPERIORITY_OR_OTHER||LSM difference|-4.51||||0.4634|TWO_SIDED|95.0|-16.6|7.57||0.05 level of significance.|Regression, Linear|||||7.57|-16.6|0.4634
72422583|NCT01576718|144356170|SUPERIORITY_OR_OTHER||LSM difference|-5.88||||0.3333|TWO_SIDED|95.0|-17.8|6.05||0.05 level of significance.|Regression, Linear|||||6.05|-17.8|0.3333
72422584|NCT01576718|144356170|SUPERIORITY_OR_OTHER||LSM difference|-8.19||||0.1763|TWO_SIDED|95.0|-20.06|3.69||0.05 level of significance.|Regression, Linear|||||3.69|-20.06|0.1763
72422585|NCT01576718|144356170|SUPERIORITY_OR_OTHER||Slope|-9.05||||0.1469|TWO_SIDED|95.0|-21.3|3.19||0.05 level of significance.|Regression, Linear|||||3.19|-21.3|0.1469
72422586|NCT01742364|144356171|SUPERIORITY_OR_OTHER|||||||0.475|||||||Fisher Exact|||Comparison of all adverse events (both injection site and systemic AEs).||||0.475
72422587|NCT01742364|144356171|SUPERIORITY_OR_OTHER|||||||0.187|||||||Fisher Exact|||Comparison of all adverse events (both injection site and systemic AEs).||||0.187
72422588|NCT01742364|144356173|SUPERIORITY_OR_OTHER|||||||0.205|||||||Wilcoxon (Mann-Whitney)|||||||0.205
72422589|NCT01742364|144356174|SUPERIORITY_OR_OTHER|||||||0.325|||||||Wilcoxon (Mann-Whitney)|||||||0.325
72422590|NCT01742364|144356175|SUPERIORITY_OR_OTHER|||||||0.001|||||||Kruskal-Wallis|||||||0.001
72422591|NCT01742364|144356175|SUPERIORITY_OR_OTHER|||||||0.13|||||||Kruskal-Wallis|||||||0.130
72422592|NCT01742364|144356176|SUPERIORITY_OR_OTHER|||||||0.001|||||||Chi-squared|||||||0.001
72422593|NCT01742364|144356176|SUPERIORITY_OR_OTHER|||||||0.003|||||||Chi-squared|||||||0.003
72422594|NCT00975221|144356223|SUPERIORITY_OR_OTHER||Cochran-Mantel-Haenszel (CMH) statistic|39.866|||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
72422595|NCT00975221|144356224|SUPERIORITY_OR_OTHER||CMH statistic|40.953|||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
72422596|NCT00975221|144356225|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-13.55|STANDARD_ERROR_OF_MEAN|1.34|<|0.001|TWO_SIDED|95.0|-16.23|-10.88|||ANCOVA|Analysis of covariance (ANCOVA) with baseline corrected serum calcium and baseline bisphosphonate included as covariates.|Treatment difference: cinacalcet-placebo|||-10.88|-16.23|<0.001
72422597|NCT00975221|144356226|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-22.79|STANDARD_ERROR_OF_MEAN|5.61|<|0.001|TWO_SIDED|95.0|-34.01|-11.57|||ANCOVA|Analysis of covariance (ANCOVA) with baseline corrected serum calcium and baseline bisphosphonate included as covariates.|Treatment difference: cinacalcet-placebo|||-11.57|-34.01|<0.001
72422598|NCT00201864|144356229|SUPERIORITY_OR_OTHER|||||||0.9102|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.9102
72422599|NCT00985985|144356287|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.22||||0.3851|TWO_SIDED|95.0|0.78|1.92|||Cochran-Mantel-Haenszel||Odds Ratio based on logistic model (adjusted by center)|Null hypothesis considered no treatment difference in the smoking cessation success rate for the active treatment versus its matching placebo.||1.92|0.78|0.3851
72331262|NCT01942668|144188313|SUPERIORITY|||||||0.015||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 12|Fisher Exact|||\>=50% Reduction||||0.015
72331263|NCT01942668|144188313|SUPERIORITY|||||||0.005||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 12|Fisher Exact|||\>=75% Reduction||||0.005
72331264|NCT01942668|144188314|SUPERIORITY|||||||0.523||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 1|Fisher Exact|||\>=50% Reduction||||0.523
72331265|NCT01942668|144188314|SUPERIORITY|||||||1||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 1|Fisher Exact|||\>=75% Reduction||||1.000
72331266|NCT01942668|144188314|SUPERIORITY|||||||0.821||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 1|Fisher Exact|||\>=50% Reduction||||0.821
72331267|NCT01942668|144188314|SUPERIORITY|||||||1||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 1|Fisher Exact|||\>=75% Reduction||||1.000
72331268|NCT01942668|144188314|SUPERIORITY|||||||0.828||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 1|Fisher Exact|||\>=50% Reduction||||0.828
72331269|NCT01942668|144188314|SUPERIORITY|||||||1||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 1|Fisher Exact|||\>=75% Reduction||||1.000
72331270|NCT01942668|144188314|SUPERIORITY|||||||0.239||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 1|Fisher Exact|||\>=50% Reduction||||0.239
72422600|NCT00985985|144356287|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.82||||0.0565|TWO_SIDED|95.0|0.99|3.32|||Cochran-Mantel-Haenszel||Odds Ratio based on logistic model (adjusted by center).|Null hypothesis considered no treatment difference in the smoking cessation success rate for the active treatment versus its matching placebo.||3.32|0.99|0.0565
72331271|NCT01942668|144188314|SUPERIORITY|||||||0.377||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 1|Fisher Exact|||\>=75% Reduction||||0.377
72331272|NCT01942668|144188315|SUPERIORITY|||||||0.036||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 2|Fisher Exact|||\>=50% Reduction||||0.036
72331273|NCT01942668|144188315|SUPERIORITY|||||||0.015||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 2|Fisher Exact|||\>=75% Reduction||||0.015
72422601|NCT00509236|144356296|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Model terms: treatment, prior diabetes pharmacotherapy (not on oral antihyperglycemic agent, or on oral antihyperglycemic agent), and a covariate for baseline A1c.||||<0.001
72331274|NCT01942668|144188315|SUPERIORITY|||||||1||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 2|Fisher Exact|||\>=50% Reduction||||1.000
72331275|NCT01942668|144188315|SUPERIORITY|||||||0.546||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 2|Fisher Exact|||\>=75% Reduction||||0.546
72331276|NCT01942668|144188315|SUPERIORITY|||||||0.352||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 2|Fisher Exact|||\>=50% Reduction||||0.352
72331277|NCT01942668|144188315|SUPERIORITY|||||||0.261||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 2|Fisher Exact|||\>=75% Reduction||||0.261
72331278|NCT01942668|144188315|SUPERIORITY|||||||0.058||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 2|Fisher Exact|||\>=50% Reduction||||0.058
72331279|NCT01942668|144188315|SUPERIORITY|||||||0.011||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 2|Fisher Exact|||\>=75% Reduction||||0.011
72331280|NCT01942668|144188316|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 3|Fisher Exact|||\>=50% Reduction||||<0.001
72331281|NCT01942668|144188316|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 3|Fisher Exact|||\>=75% Reduction||||<0.001
72331282|NCT01942668|144188316|SUPERIORITY|||||||0.115||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 3|Fisher Exact|||\>=50% Reduction||||0.115
72331283|NCT01942668|144188316|SUPERIORITY|||||||0.11||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 3|Fisher Exact|||\>=75% Reduction||||0.110
72331284|NCT01942668|144188316|SUPERIORITY|||||||0.089||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 3|Fisher Exact|||\>=50% Reduction||||0.089
72331285|NCT01942668|144188316|SUPERIORITY|||||||0.074||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 3|Fisher Exact|||\>=75% Reduction||||0.074
72331286|NCT01942668|144188316|SUPERIORITY|||||||0.011||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 3|Fisher Exact|||\>=50% Reduction||||0.011
72331287|NCT01942668|144188316|SUPERIORITY|||||||0.008||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 3|Fisher Exact|||\>=75% Reduction||||0.008
72331288|NCT01942668|144188317|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 4|Fisher Exact|||\>=50% Reduction||||<0.001
72422602|NCT00509236|144356297|SUPERIORITY_OR_OTHER||Difference in % Affected|-4.8||||0.336|TWO_SIDED|95.0|-15.7|5.6||Miettinen \& Nurminen method stratified by prior diabetes pharmacotherapy (not on oral antihyperglycemic agent, or on oral antihyperglycemic agent).|Miettinen & Nurminen|||||5.6|-15.7|0.336
72422603|NCT00509236|144356298|SUPERIORITY_OR_OTHER||Difference in % Affected|2.8|||||TWO_SIDED|95.0|-10.9|16.5||||||||16.5|-10.9|
72422604|NCT00509236|144356299|SUPERIORITY_OR_OTHER||Change from Baseline in LS Mean|-26.6|||<|0.001|TWO_SIDED|95.0|-38.0|-15.3|||ANCOVA|||Model terms: treatment, prior diabetes pharmacotherapy (not on oral antihyperglycemic agent, or on oral antihyperglycemic agent), and a covariate for baseline FPG.||-15.3|-38.0|<0.001
72331289|NCT01942668|144188317|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 4|Fisher Exact|||\>=75% Reduction||||<0.001
72331290|NCT01942668|144188317|SUPERIORITY|||||||0.011||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 4|Fisher Exact|||\>=50% Reduction||||0.011
72331291|NCT01942668|144188317|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 4|Fisher Exact|||\>=75% Reduction||||<0.001
72331292|NCT01942668|144188317|SUPERIORITY|||||||0.002||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 4|Fisher Exact|||\>=50% Reduction||||0.002
72331293|NCT01942668|144188317|SUPERIORITY|||||||0.002||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 4|Fisher Exact|||\>=75% Reduction||||0.002
72422605|NCT00509236|144356299|SUPERIORITY_OR_OTHER||Change from Baseline in LS Mean|-31.2|||<|0.001|TWO_SIDED|95.0|-42.6|-19.9|||ANCOVA|||Model terms: treatment, prior diabetes pharmacotherapy (not on oral antihyperglycemic agent, or on oral antihyperglycemic agent), and a covariate for baseline FPG.||-19.9|-42.6|<0.001
72422606|NCT00509236|144356299|SUPERIORITY_OR_OTHER||Difference in LS Means|4.6|||||TWO_SIDED|95.0|-11.5|20.7||||||Model terms: treatment, prior diabetes pharmacotherapy (not on oral antihyperglycemic agent, or on oral antihyperglycemic agent), and a covariate for baseline FPG.||20.7|-11.5|
72422607|NCT00509236|144356300|SUPERIORITY_OR_OTHER||Difference in LS Means|0.15|||||TWO_SIDED|95.0|-0.18|0.49|||ANCOVA|||Model terms: treatment, prior diabetes pharmacotherapy (not on oral antihyperglycemic agent, or on oral antihyperglycemic agent), and a covariate for baseline A1c.||0.49|-0.18|
72553916|NCT00838136|144639940|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|101.87||||||90.0|99.18|104.63|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||104.63|99.18|
72331294|NCT01942668|144188317|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 4|Fisher Exact|||\>=50% Reduction||||<0.001
72331295|NCT01942668|144188317|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 4|Fisher Exact|||\>=75% Reduction||||<0.001
72331296|NCT01942668|144188318|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 5|Fisher Exact|||\>=50% Reduction||||<0.001
72331297|NCT01942668|144188318|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 5|Fisher Exact|||\>=75% Reduction||||<0.001
72331298|NCT01942668|144188318|SUPERIORITY|||||||0.048||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 5|Fisher Exact|||\>=50% Reduction||||0.048
72331299|NCT01942668|144188318|SUPERIORITY|||||||0.006||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 5|Fisher Exact|||\>=75% Reduction||||0.006
72331300|NCT01942668|144188318|SUPERIORITY|||||||0.063||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 5|Fisher Exact|||\>=50% Reduction||||0.063
72331301|NCT01942668|144188318|SUPERIORITY|||||||0.058||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 5|Fisher Exact|||\>=75% Reduction||||0.058
72331302|NCT01942668|144188318|SUPERIORITY|||||||0.004||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 5|Fisher Exact|||\>=50% Reduction||||0.004
72331303|NCT01942668|144188318|SUPERIORITY|||||||0.003||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 5|Fisher Exact|||\>=75% Reduction||||0.003
72331304|NCT01942668|144188319|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 6|Fisher Exact|||\>=50% Reduction||||<0.001
72331305|NCT01942668|144188319|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 6|Fisher Exact|||\>=75% Reduction||||<0.001
72331306|NCT01942668|144188319|SUPERIORITY|||||||0.05||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 6|Fisher Exact|||\>=50% Reduction||||0.050
72553917|NCT00838136|144639941|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|100.76||||||90.0|98.6|102.97|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||102.97|98.60|
72331307|NCT01942668|144188319|SUPERIORITY|||||||0.006||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 6|Fisher Exact|||\>=75% Reduction||||0.006
72331308|NCT01942668|144188319|SUPERIORITY|||||||0.048||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 6|Fisher Exact|||\>=50% Reduction||||0.048
72331309|NCT01942668|144188319|SUPERIORITY|||||||0.004||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 6|Fisher Exact|||\>=75% Reduction||||0.004
72331310|NCT01942668|144188319|SUPERIORITY|||||||0.02||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 6|Fisher Exact|||\>=50% Reduction||||0.020
72331311|NCT01942668|144188319|SUPERIORITY|||||||0.001||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 6|Fisher Exact|||\>=75% Reduction||||0.001
72331312|NCT01942668|144188320|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 7|Fisher Exact|||\>=50% Reduction||||<0.001
72331313|NCT01942668|144188320|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 7|Fisher Exact|||\>=75% Reduction||||<0.001
72331314|NCT01942668|144188320|SUPERIORITY|||||||0.001||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 7|Fisher Exact|||\>=50% Reduction||||0.001
72331315|NCT01942668|144188320|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 7|Fisher Exact|||\>=75% Reduction||||<0.001
72331316|NCT01942668|144188320|SUPERIORITY|||||||0.006||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 7|Fisher Exact|||\>=50% Reduction||||0.006
72331317|NCT01942668|144188320|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 7|Fisher Exact|||\>=75% Reduction||||<0.001
72331318|NCT01942668|144188320|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 7|Fisher Exact|||\>=50% Reduction||||<0.001
72331319|NCT01942668|144188320|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 7|Fisher Exact|||\>=75% Reduction||||<0.001
72331320|NCT01942668|144188321|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 8|Fisher Exact|||\>=50% Reduction||||<0.001
72331321|NCT01942668|144188321|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 8|Fisher Exact|||\>=75% Reduction||||<0.001
72331322|NCT01942668|144188321|SUPERIORITY|||||||0.013||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 8|Fisher Exact|||\>=50% Reduction||||0.013
72331323|NCT01942668|144188321|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 8|Fisher Exact|||\>=75% Reduction||||<0.001
72331324|NCT01942668|144188321|SUPERIORITY|||||||0.001||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 8|Fisher Exact|||\>=50% Reduction||||0.001
72331325|NCT01942668|144188321|SUPERIORITY|||||||0.004||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 8|Fisher Exact|||\>=75% Reduction||||0.004
72331326|NCT01942668|144188321|SUPERIORITY|||||||0.003||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 8|Fisher Exact|||\>=50% Reduction||||0.003
72331327|NCT01942668|144188321|SUPERIORITY|||||||0.001||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 8|Fisher Exact|||\>=75% Reduction||||0.001
72331328|NCT01942668|144188322|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 9|Fisher Exact|||\>=50% Reduction||||<0.001
72331329|NCT01942668|144188322|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 9|Fisher Exact|||\>=75% Reduction||||<0.001
72331330|NCT01942668|144188322|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 9|Fisher Exact|||\>=50% Reduction||||<0.001
72331331|NCT01942668|144188322|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 9|Fisher Exact|||\>=75% Reduction||||<0.001
72331332|NCT01942668|144188322|SUPERIORITY|||||||0.001||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 9|Fisher Exact|||\>=50% Reduction||||0.001
72331333|NCT01942668|144188322|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 9|Fisher Exact|||\>=75% Reduction||||<0.001
72331334|NCT01942668|144188322|SUPERIORITY|||||||0.004||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 9|Fisher Exact|||\>=50% Reduction||||0.004
72331335|NCT01942668|144188322|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 9|Fisher Exact|||\>=75% Reduction||||<0.001
72331336|NCT01942668|144188323|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 10|Fisher Exact|||\>=50% Reduction||||<0.001
72331337|NCT01942668|144188323|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 10|Fisher Exact|||\>=75% Reduction||||<0.001
72331338|NCT01942668|144188323|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 10|Fisher Exact|||\>=50% Reduction||||<0.001
72331339|NCT01942668|144188323|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 10|Fisher Exact|||\>=75% Reduction||||<0.001
72331340|NCT01942668|144188323|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 10|Fisher Exact|||\>=50% Reduction||||<0.001
72331341|NCT01942668|144188323|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 10|Fisher Exact|||\>=75% Reduction||||<0.001
72331342|NCT01942668|144188323|SUPERIORITY|||||||0.001||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 10|Fisher Exact|||\>=50% Reduction||||0.001
72331343|NCT01942668|144188323|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 10|Fisher Exact|||\>=75% Reduction||||<0.001
72331344|NCT01942668|144188324|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 11|Fisher Exact|||\>=50% Reduction||||<0.001
72331345|NCT01942668|144188324|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 11|Fisher Exact|||\>=75% Reduction||||<0.001
72331346|NCT01942668|144188324|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 11|Fisher Exact|||\>=50% Reduction||||<0.001
72331347|NCT01942668|144188324|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 11|Fisher Exact|||\>=75% Reduction||||<0.001
72331348|NCT01942668|144188324|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 11|Fisher Exact|||\>=50% Reduction||||<0.001
72331349|NCT01942668|144188324|SUPERIORITY|||||||0.003||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 11|Fisher Exact|||\>=75% Reduction||||0.003
72331350|NCT01942668|144188324|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 11|Fisher Exact|||\>=50% Reduction||||<0.001
72331351|NCT01942668|144188324|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 11|Fisher Exact|||\>=75% Reduction||||<0.001
72422608|NCT03587142|144356322|SUPERIORITY||Mean Difference (Net)|-0.11||||0.69|TWO_SIDED|95.0|-0.68|0.45||Nominal P value. Power was determined at a level of P=0.05.|ANCOVA|Multiple imputation using regression and 50 datasets to estimate the outcome for the 18/96 (19%) randomized patients without the f4 visit data.||Primary outcome analysis uses a difference of differences analysis between Buspirone compared to the Placebo arm in which the adjusted mean difference of differences, Wald 95% Confidence interval and 2-sided P values are determined from a Wald Chi-Square test. Adjusted mean difference of differences (DoD) from baseline were computed using ANCOVA, regressing change from baseline to 4-weeks on treatment group and baseline value of the outcome. Negative change indicates symptom improvement.||0.45|-0.68|0.69
72331352|NCT01942668|144188325|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 12|Fisher Exact|||\>=50% Reduction||||<0.001
72331353|NCT01942668|144188325|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 12|Fisher Exact|||\>=75% Reduction||||<0.001
72331354|NCT01942668|144188325|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 12|Fisher Exact|||\>=50% Reduction||||<0.001
72331355|NCT01942668|144188325|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 12|Fisher Exact|||\>=75% Reduction||||<0.001
72331356|NCT01942668|144188325|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 12|Fisher Exact|||\>=50% Reduction||||<0.001
72331357|NCT01942668|144188325|SUPERIORITY|||||||0.056||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 12|Fisher Exact|||\>=75% Reduction||||0.056
72331358|NCT01942668|144188325|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 12|Fisher Exact|||\>=50% Reduction||||<0.001
72331359|NCT01942668|144188325|SUPERIORITY|||||||0.017||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 12|Fisher Exact|||\>=75% Reduction||||0.017
72331360|NCT01942668|144188326|SUPERIORITY||||||<|0.001||||||P-value is derived from comparing % Very Much Improved+Much Improved between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 4|Fisher Exact|||||||<0.001
72331361|NCT01942668|144188326|SUPERIORITY|||||||0.005||||||P-value is derived from comparing % Very Much Improved+Much Improved between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 4|Fisher Exact|||||||0.005
72331362|NCT01942668|144188326|SUPERIORITY|||||||0.007||||||P-value is derived from comparing % Very Much Improved+Much Improved between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 4|Fisher Exact|||||||0.007
72331363|NCT01942668|144188326|SUPERIORITY|||||||0.004||||||P-value is derived from comparing % Very Much Improved+Much Improved between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 4|Fisher Exact|||||||0.004
72331364|NCT01942668|144188328|SUPERIORITY||||||<|0.001||||||P-value is derived from comparing % Very Much Improved+Much Improved between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 8|Fisher Exact|||||||<0.001
72331365|NCT01942668|144188328|SUPERIORITY||||||<|0.001||||||P-value is derived from comparing % Very Much Improved+Much Improved between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 8|Fisher Exact|||||||<0.001
72331366|NCT01942668|144188328|SUPERIORITY|||||||0.001||||||P-value is derived from comparing % Very Much Improved+Much Improved between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 8|Fisher Exact|||||||0.001
72331367|NCT01942668|144188328|SUPERIORITY|||||||0.002||||||P-value is derived from comparing % Very Much Improved+Much Improved between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 8|Fisher Exact|||||||0.002
72331368|NCT01942668|144188330|SUPERIORITY||||||<|0.001||||||P-value is derived from comparing % Very Much Improved+Much Improved between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 12|Fisher Exact|||||||<0.001
72331369|NCT01942668|144188330|SUPERIORITY||||||<|0.001||||||P-value is derived from comparing % Very Much Improved+Much Improved between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 12|Fisher Exact|||||||<0.001
72331370|NCT01942668|144188330|SUPERIORITY||||||<|0.001||||||P-value is derived from comparing % Very Much Improved+Much Improved between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 12|Fisher Exact|||||||<0.001
72331371|NCT01942668|144188330|SUPERIORITY|||||||0.002||||||P-value is derived from comparing % Very Much Improved+Much Improved between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 12|Fisher Exact|||||||0.002
72331372|NCT01942668|144188332|SUPERIORITY|||||||0|||||||Fisher Exact|||||||0.000
72331373|NCT01942668|144188332|SUPERIORITY|||||||0.122|||||||Fisher Exact|||||||0.122
72331374|NCT01942668|144188332|SUPERIORITY|||||||0.28|||||||Fisher Exact|||||||0.280
72331375|NCT01942668|144188332|SUPERIORITY|||||||0.692|||||||Fisher Exact|||||||0.692
72331376|NCT01942668|144188333|SUPERIORITY|||||||0|||||||Fisher Exact|||||||0.000
72331377|NCT01942668|144188333|SUPERIORITY|||||||0.069|||||||Fisher Exact|||||||0.069
72331378|NCT01942668|144188333|SUPERIORITY|||||||0.131|||||||Fisher Exact|||||||0.131
72331379|NCT01942668|144188333|SUPERIORITY|||||||0.661|||||||Fisher Exact|||||||0.661
72331380|NCT01942668|144188334|SUPERIORITY|||||||0|||||||Fisher Exact|||||||0.000
72331381|NCT01942668|144188334|SUPERIORITY|||||||0.04|||||||Fisher Exact|||||||0.040
72331382|NCT01942668|144188334|SUPERIORITY|||||||0.082|||||||Fisher Exact|||||||0.082
72331383|NCT01942668|144188334|SUPERIORITY|||||||0.495|||||||Fisher Exact|||||||0.495
72331384|NCT01942668|144188335|SUPERIORITY|||||||0|||||||Fisher Exact|||||||0.000
72331385|NCT01942668|144188335|SUPERIORITY|||||||0.032|||||||Fisher Exact|||||||0.032
72331386|NCT01942668|144188335|SUPERIORITY|||||||0.137|||||||Fisher Exact|||||||0.137
72331387|NCT01942668|144188335|SUPERIORITY|||||||0.792|||||||Fisher Exact|||||||0.792
72331388|NCT01942668|144188336|SUPERIORITY|||||||0|||||||Fisher Exact|||||||0.000
72331389|NCT01942668|144188336|SUPERIORITY|||||||0.067|||||||Fisher Exact|||||||0.067
72422609|NCT03587142|144356322|SUPERIORITY||Mean Difference (Net)|-0.13||||0.62|TWO_SIDED|95.0|-0.65|0.39||P value is nominal; no adjustments made from multiple comparisons. Bonferroni p-value for the 10 sensitivity outcomes is \<0.005.|ANCOVA|||Sensitivity analysis of change from a baseline in ES/PPF (Early Satiety/Postprandial Fullness subscore) using all completers: 39 participants in Buspirone arm, 39 participants in placebo arm.||0.39|-0.65|0.62
72331390|NCT01942668|144188336|SUPERIORITY|||||||0.26|||||||Fisher Exact|||||||0.260
72331391|NCT01942668|144188336|SUPERIORITY|||||||0.792|||||||Fisher Exact|||||||0.792
72331392|NCT01942668|144188337|SUPERIORITY|||||||0.001|||||||Fisher Exact|||||||0.001
72331393|NCT01942668|144188337|SUPERIORITY|||||||0.095|||||||Fisher Exact|||||||0.095
72331394|NCT01942668|144188337|SUPERIORITY|||||||0.352|||||||Fisher Exact|||||||0.352
72331395|NCT01942668|144188337|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.000
72331396|NCT01942668|144188338|SUPERIORITY|||||||0.002|||||||Fisher Exact|||||||0.002
72331397|NCT01942668|144188338|SUPERIORITY|||||||0.075|||||||Fisher Exact|||||||0.075
72331398|NCT01942668|144188338|SUPERIORITY|||||||0.225|||||||Fisher Exact|||||||0.225
72331399|NCT01942668|144188338|SUPERIORITY|||||||0.769|||||||Fisher Exact|||||||0.769
72331400|NCT01942668|144188339|SUPERIORITY|||||||0.002|||||||Fisher Exact|||||||0.002
72331401|NCT01942668|144188339|SUPERIORITY|||||||0.084|||||||Fisher Exact|||||||0.084
72331402|NCT01942668|144188339|SUPERIORITY|||||||0.183|||||||Fisher Exact|||||||0.183
72331403|NCT01942668|144188339|SUPERIORITY|||||||0.738|||||||Fisher Exact|||||||0.738
72331404|NCT01942668|144188340|SUPERIORITY|||||||0.006|||||||Fisher Exact|||||||0.006
72331405|NCT01942668|144188340|SUPERIORITY|||||||0.125|||||||Fisher Exact|||||||0.125
72331406|NCT01942668|144188340|SUPERIORITY|||||||0.386|||||||Fisher Exact|||||||0.386
72331407|NCT01942668|144188340|SUPERIORITY|||||||0.737|||||||Fisher Exact|||||||0.737
72331408|NCT01942668|144188341|SUPERIORITY|||||||0.009|||||||Fisher Exact|||||||0.009
72331409|NCT01942668|144188341|SUPERIORITY|||||||0.183|||||||Fisher Exact|||||||0.183
72331410|NCT01942668|144188341|SUPERIORITY|||||||0.745|||||||Fisher Exact|||||||0.745
72331411|NCT01942668|144188341|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.000
72331412|NCT01942668|144188342|SUPERIORITY|||||||0.035|||||||Fisher Exact|||||||0.035
72331413|NCT01942668|144188342|SUPERIORITY|||||||0.536|||||||Fisher Exact|||||||0.536
72331414|NCT01942668|144188342|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.000
72331415|NCT01942668|144188342|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.000
72331416|NCT01942668|144188343|SUPERIORITY|||||||0.261|||||||Fisher Exact|||||||0.261
72331417|NCT01942668|144188343|SUPERIORITY|||||||0.536|||||||Fisher Exact|||||||0.536
72331418|NCT01942668|144188343|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.000
72331419|NCT01942668|144188343|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.000
72331420|NCT01942668|144188344|SUPERIORITY|||||||0.463|||||||Fisher Exact|||||||0.463
72331421|NCT01942668|144188344|SUPERIORITY|||||||0.687|||||||Fisher Exact|||||||0.687
72331422|NCT01942668|144188344|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.000
72331423|NCT01942668|144188344|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.000
72331424|NCT01942668|144188345|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||<0.001
72331425|NCT01942668|144188345|SUPERIORITY|||||||0.048|||||||Fisher Exact|||||||0.048
72331426|NCT01942668|144188345|SUPERIORITY|||||||0.049|||||||Fisher Exact|||||||0.049
72331427|NCT01942668|144188345|SUPERIORITY|||||||0.328|||||||Fisher Exact|||||||0.328
72331428|NCT01942668|144188346|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||<0.001
72331429|NCT01942668|144188346|SUPERIORITY|||||||0.123|||||||Fisher Exact|||||||0.123
72331430|NCT01942668|144188346|SUPERIORITY|||||||0.03|||||||Fisher Exact|||||||0.030
72331431|NCT01942668|144188346|SUPERIORITY|||||||0.649|||||||Fisher Exact|||||||0.649
72331432|NCT01942668|144188347|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||<0.001
72331433|NCT01942668|144188347|SUPERIORITY|||||||0.059|||||||Fisher Exact|||||||0.059
72331434|NCT01942668|144188347|SUPERIORITY|||||||0.023|||||||Fisher Exact|||||||0.023
72331435|NCT01942668|144188347|SUPERIORITY|||||||0.426|||||||Fisher Exact|||||||0.426
72331436|NCT01942668|144188348|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||<0.001
72331437|NCT01942668|144188348|SUPERIORITY|||||||0.044|||||||Fisher Exact|||||||0.044
72331438|NCT01942668|144188348|SUPERIORITY|||||||0.011|||||||Fisher Exact|||||||0.011
72331439|NCT01942668|144188348|SUPERIORITY|||||||0.481|||||||Fisher Exact|||||||0.481
72331440|NCT01942668|144188349|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||<0.001
72331441|NCT01942668|144188349|SUPERIORITY|||||||0.11|||||||Fisher Exact|||||||0.110
72331442|NCT01942668|144188349|SUPERIORITY|||||||0.045|||||||Fisher Exact|||||||0.045
72331443|NCT01942668|144188349|SUPERIORITY|||||||0.853|||||||Fisher Exact|||||||0.853
72422610|NCT03587142|144356322|SUPERIORITY||Mean Difference (Net)|-0.25||||0.62|TWO_SIDED|95.0|-0.89|0.38||P value is nominal; no adjustments made for multiple comparisons. Bonferroni p-value for the 10 sensitivity outcomes is \<0.005|ANCOVA|||Sensitivity analyses: change in ES/PPF in treatment adherent patients: 23 participants in Buspirone arm, 29 patients in placebo arm.||0.38|-0.89|0.62
72422611|NCT03587142|144356323|SUPERIORITY||Mean Difference (Net)|-0.09||||0.76|TWO_SIDED|95.0|-0.69|0.5||Nominal P value reported. Bonferroni p-value for the 10 sensitivity outcomes is \<0.005|ANCOVA|||The mean difference of differences (DoD) between Buspirone and Placebo, 95% confidence interval and P (2-sided) were derived from an ANCOVA, regressing an indicator for treatment group on fullness severity score, adjusting for the baseline value of fullness severity score.||0.50|-0.69|0.76
72422612|NCT03587142|144356324|SUPERIORITY||Mean Difference (Net)|-0.15||||0.64|TWO_SIDED|95.0|-0.76|0.47||Nominal P values; Bonferroni p value for the 10 sensitivity outcomes is \<0.005|ANCOVA|||Adjusted mean difference of differences (DoD) from baseline were computed using ANCOVA, regressing change from baseline to 4-weeks on treatment group and baseline value of the outcome. Wald 95% Confidence Limits (CI) are reported; P (2-sided) determined from a Wald Chi-Square test.||0.47|-0.76|0.64
72422613|NCT03587142|144356325|SUPERIORITY||Mean Difference (Net)|-0.14||||0.66|TWO_SIDED|95.0|-0.79|0.5||P values are nominal; Bonferroni p-value for the 10 sensitivity outcomes is \<0.005|ANCOVA|||Adjusted mean difference of differences (DoD) from baseline were computed using ANCOVA, regressing change from baseline to 4-weeks on treatment group and baseline value of the outcome. Wald 95% Confidence Limits (CI) are reported; P (2-sided) determined from a Wald Chi-Square test.||0.50|-0.79|0.66
72422614|NCT03587142|144356326|SUPERIORITY||Mean Difference (Net)|-0.12||||0.7|TWO_SIDED|95.0|-0.75|0.5||Nominal P values; Bonferroni p-value for the 10 sensitivity outcomes is \<0.005|ANCOVA|||Adjusted mean difference of differences (DoD) from baseline were computed using ANCOVA, regressing change from baseline to 4-weeks on treatment group and baseline value of the outcome. Wald 95% Confidence Limits (CI) are reported; P (s-sided) determined from a Wald Chi-Square test.||0.50|-0.75|0.70
72422615|NCT03587142|144356327|SUPERIORITY||Mean Difference (Net)|-0.2||||0.4|TWO_SIDED|95.0|-0.66|0.27||P value is nominal; no adjustments made for multiple comparisons. Bonferrini p-value is \<0.002|ANCOVA|||Adjusted mean difference of differences (DoD) of change in outcome from baseline and 95% Confidence Intervals were computed using ANCOVA, regressing change from baseline to 4-weeks on treatment group and baseline value of the outcome. P (2-sided) were determined from a Wald Chi-Square test.||0.27|-0.66|0.40
72331444|NCT01942668|144188350|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||<0.001
72331445|NCT01942668|144188350|SUPERIORITY|||||||0.245|||||||Fisher Exact|||||||0.245
72331446|NCT01942668|144188350|SUPERIORITY|||||||0.145|||||||Fisher Exact|||||||0.145
72331447|NCT01942668|144188350|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.000
72331448|NCT01942668|144188351|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||<0.001
72331449|NCT01942668|144188351|SUPERIORITY|||||||0.163|||||||Fisher Exact|||||||0.163
72331450|NCT01942668|144188351|SUPERIORITY|||||||0.091|||||||Fisher Exact|||||||0.091
72331451|NCT01942668|144188351|SUPERIORITY|||||||0.693|||||||Fisher Exact|||||||0.693
72331452|NCT01942668|144188352|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||<0.001
72331453|NCT01942668|144188352|SUPERIORITY|||||||0.178|||||||Fisher Exact|||||||0.178
72422616|NCT03587142|144356327|SUPERIORITY||Odds Ratio (OR)|1.31||||0.56|TWO_SIDED|95.0|0.53|3.21||Nominal P value without adjustment for multiple comparisons. Bonferroni threshold for level of significance is \<0.002.|Regression, Logistic|Odds ratio, 95% C.I. and P (two-sided) from a logistic regression of the binary outcome on treatment group for symptomatic improvement in GCSI.||GCSI symptomatic improvement of 1+ points in total GCSI symptom score defined as change in GCSI total score at week 4 from baseline being a decrease of 1 or more points. This is a binary variable where 1=1+ reduction in change in GCSI total score, 0=change in GCSI total score from baseline at 4-weeks is \< 1.0.||3.21|0.53|0.56
72422617|NCT03587142|144356328|SUPERIORITY||Mean Difference (Net)|-0.05||||0.86|TWO_SIDED|95.0|-0.58|0.48||P value is nominal: no adjustments made for multiple comparisons. Bonferroni p-value threshold for the level of significance is \<0.002|ANCOVA|||Adjusted mean difference of differences (DoD) from baseline were computed using ANCOVA, regressing change from baseline to 4-weeks on treatment group and baseline value of the outcome. Wald 95% Confidence Limits (CI) are reported; P (2-sided) determined from a Wald Chi-Squares test.||0.48|-0.58|0.86
72422618|NCT03587142|144356329|SUPERIORITY||Mean Difference (Net)|-0.06||||0.85|TWO_SIDED|95.0|-0.64|0.53||P value is nominal; no adjustments made for multiple comparisons. Bonferroni p-value is \<0.002|ANCOVA|||Adjusted mean difference of differences (DoD) from baseline were computed using ANCOVA, regressing change from baseline to 4-weeks on treatment group and baseline value of outcome. Wald 95% Confidence Limits (CI) are reported; P (2-sided) determined from a Wald-Chi Square test.||0.53|-0.64|0.85
72331454|NCT01942668|144188352|SUPERIORITY|||||||0.097|||||||Fisher Exact|||||||0.097
72331455|NCT01942668|144188352|SUPERIORITY|||||||0.522|||||||Fisher Exact|||||||0.522
72331456|NCT01942668|144188353|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||<0.001
72331457|NCT01942668|144188353|SUPERIORITY|||||||0.315|||||||Fisher Exact|||||||0.315
72331458|NCT01942668|144188353|SUPERIORITY|||||||0.181|||||||Fisher Exact|||||||0.181
72331459|NCT01942668|144188353|SUPERIORITY|||||||0.821|||||||Fisher Exact|||||||0.821
72331460|NCT01942668|144188354|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||<0.001
72331461|NCT01942668|144188354|SUPERIORITY|||||||0.387|||||||Fisher Exact|||||||0.387
72331462|NCT01942668|144188354|SUPERIORITY|||||||0.215|||||||Fisher Exact|||||||0.215
72331463|NCT01942668|144188354|SUPERIORITY|||||||0.639|||||||Fisher Exact|||||||0.639
72331464|NCT01942668|144188355|SUPERIORITY|||||||0.008|||||||Fisher Exact|||||||0.008
72331465|NCT01942668|144188355|SUPERIORITY|||||||0.643|||||||Fisher Exact|||||||0.643
72331466|NCT01942668|144188355|SUPERIORITY|||||||0.501|||||||Fisher Exact|||||||0.501
72331467|NCT01942668|144188355|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.000
72331468|NCT01942668|144188356|SUPERIORITY|||||||0.013|||||||Fisher Exact|||||||0.013
72331469|NCT01942668|144188356|SUPERIORITY|||||||0.616|||||||Fisher Exact|||||||0.616
72422619|NCT03587142|144356330|SUPERIORITY||Mean Difference (Net)|-0.14||||0.65|TWO_SIDED|95.0|-0.76|0.47||P value is nominal; no adjustments made for multiple comparisons. Bonferroni p-value is \<0.002|ANCOVA|||Adjusted mean difference of differences (DoD) from baseline were computed using ANCOVA, regressing change from baseline to 4-weeks on treatment group and baseline value of the outcome. Wald 95% Confidence Limits (CI) are reported; P (2-sided) determined from a Wald Chi-Square test||0.47|-0.76|0.65
72422620|NCT03587142|144356331|SUPERIORITY||Mean Difference (Net)|-0.41||||0.16|TWO_SIDED|95.0|-0.99|0.16||P value is nominal: no adjustments made for multiple comparisons. Bonferroni p-value threshold level of significance is \<0.002|ANCOVA|||Adjusted mean difference of differences (DoD) from baseline were computed using ANCOVA, regressing change from baseline to 4-weeks on treatment group and baseline value of the outcome. Wald 95% Confidence Limits (CI) are reported; P (2-sided) determined from a Wald Chi-Square test.||0.16|-0.99|0.16
72422621|NCT03587142|144356332|SUPERIORITY||Mean Difference (Net)|-0.65||||0.03|TWO_SIDED|95.0|-1.23|-0.08||P values are nominal; no adjustments made for multiple comparisons.|ANCOVA|||Adjusted mean difference of differences (DoD) from baseline were computed using ANCOVA, regressing change from baseline to 4-weeks on treatment group and baseline value of the outcome. Wald 95% Confidence Limits (CI) are reported; P (2-sided) determined from a Wald Chi-Square test.||-0.08|-1.23|0.03
72422622|NCT03587142|144356333|SUPERIORITY||Mean Difference (Net)|0.17||||0.59|TWO_SIDED|95.0|-0.44|0.77||P value is nominal: no adjustments made for multiple comparisons. Bonferroni p-value threshold for the level of significance is \<0.002|ANCOVA|||Adjusted mean difference of differences (DoD) from baseline were computed using ANCOVA, regressing change from baseline to 4-weeks on treatment group and baseline value of the outcome. Wald 95% Confidence Limits (CI) are reported; P (2-sided) determined from a Wald Chi-Square test.||0.77|-0.44|0.59
72422623|NCT03587142|144356334|SUPERIORITY||Mean Difference (Net)|0.24||||0.46|TWO_SIDED|95.0|-0.39|0.88||P value is nominal: no adjustments made for multiple comparisons. Bonferroni p-value threshold for the level of significance is \<0.002|ANCOVA|||Adjusted mean difference of differences (DoD) from baseline were computed using ANCOVA, regressing change from baseline to 4-weeks on treatment group and baseline value of the outcome. Wald 95% Confidence Limits (CI) are reported; P (2-sided) determined from a Wald Chi-Square test.||0.88|-0.39|0.46
72331470|NCT01942668|144188356|SUPERIORITY|||||||0.352|||||||Fisher Exact|||||||0.352
72331471|NCT01942668|144188356|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.000
72422624|NCT03587142|144356335|SUPERIORITY||Mean Difference (Net)|0.09||||0.73|TWO_SIDED|95.0|-0.42|0.59||P value is nominal: no adjustments made for multiple comparisons. Bonferroni p-value threshold for the level of significance is \<0.002|ANCOVA|||Adjusted mean difference of differences (DoD) from baseline were computed using ANCOVA, regressing change from baseline to 4-weeks on treatment group and baseline value of the outcome. Wald 95% Confidence Limits (CI) are reported; P (2-sided) determined from a Wald Chi-Square test.||0.59|-0.42|0.73
72422625|NCT03587142|144356336|SUPERIORITY||Mean Difference (Net)|-0.14||||0.5|TWO_SIDED|95.0|-0.55|0.27||P value is nominal: no adjustments made for multiple comparisons. Bonferroni p-value threshold for the level of significance is \<0.002|ANCOVA|||Adjusted mean difference of differences (DoD) from baseline were computed using ANCOVA, regressing change from baseline to 4-weeks on treatment group and baseline value of the outcome. Wald 95% Confidence Limits (CI) are reported; P (2-sided) determined from a Wald Chi-Square test.||0.27|-0.55|0.50
72331472|NCT01942668|144188357|SUPERIORITY|||||||0.023|||||||Fisher Exact|||||||0.023
72331473|NCT01942668|144188357|SUPERIORITY|||||||0.535|||||||Fisher Exact|||||||0.535
72331474|NCT01942668|144188357|SUPERIORITY|||||||0.183|||||||Fisher Exact|||||||0.183
72331475|NCT01942668|144188357|SUPERIORITY|||||||0.738|||||||Fisher Exact|||||||0.738
72422626|NCT03587142|144356337|SUPERIORITY||Mean Difference (Net)|0.32||||0.18|TWO_SIDED|95.0|-0.15|0.79||P value is nominal: no adjustments made for multiple comparisons. Bonferroni p-value threshold for the level of significance is \<0.002|ANOVA|||Adjusted mean difference of differences (DoD) from baseline were computed using ANCOVA, regressing change from baseline to 4-weeks on treatment group and baseline value of the outcome. Wald 95% Confidence Limits (CI) are reported; P (2-sided) determined from a Wald Chi-Square test.||0.79|-0.15|0.18
72331476|NCT01942668|144188358|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo during Trimester 1|Fisher Exact|||||||<0.001
72422627|NCT03587142|144356338|SUPERIORITY||Mean Difference (Net)|1.01||||0.19|TWO_SIDED|95.0|-0.49|2.51||P value is nominal: no adjustments made from multiple comparisons. Bonferroni p-value threshold for the level of significance is \<0.002.|ANCOVA|||Adjusted mean difference from differences (DoD) from the baseline were computed using ANCOVA, regressing change from baseline to 4-weeks on treatment group and baseline value of the outcome. Wald 95% Confidence Intervals are reported; P value (2-sided) determined from a Wald Chi-Square test.||2.51|-0.49|0.19
72422628|NCT03587142|144356339|SUPERIORITY||Mean Difference (Net)|1.86||||0.02|TWO_SIDED|95.0|0.33|3.38||P value is nominal: no adjustments made for multiple comparisons. Bonferroni P-value threshold for the level of significance is \<=0.002|ANCOVA|||Adjusted mean difference of differences (DoD) from baseline were computed using ANCOVA, regressing change from baseline to 4-weeks on treatment group and baseline value of the HADS depression score.||3.38|0.33|0.02
72422629|NCT03587142|144356340|SUPERIORITY||Mean Difference (Net)|0.76||||0.4|TWO_SIDED|95.0|-1.02|2.54||P values are nominal; no adjustments for multiple comparisons|ANCOVA|||Adjusted mean difference of differences (DoD) from baseline were computed using ANCOVA, regressing change from baseline to 4-weeks on treatment group and baseline value of the HADS anxiety total score. 95% Wald Confidence Intervals are reported; P (2-sided) determined from a Wald Chi-Square test||2.54|-1.02|0.40
72331477|NCT01942668|144188358|SUPERIORITY|||||||0.004||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo during Trimester 1|Fisher Exact|||||||0.004
72422630|NCT03587142|144356341|SUPERIORITY||Mean Difference (Net)|-0.21||||0.25|TWO_SIDED|95.0|-0.57|0.15||P value is nominal with no adjustment for multiple comparisons. The Bonferroni level of significance threshold is \<=0.002.|ANCOVA|||Adjusted mean difference of differences (DoD) from baseline were computed using ANCOVA, regressing change from baseline to 4-weeks on treatment group and baseline value of PAGI-QOL total score.||0.15|-0.57|0.25
72422631|NCT03587142|144356342|SUPERIORITY||Mean Difference (Net)|-1.98||||0.36|TWO_SIDED|95.0|-6.2|2.24|||ANCOVA|||Adjusted mean difference of differences (DoD) of change in outcome from baseline and 95% Confidence Intervals were computed using ANCOVA, regressing change from baseline to 4-weeks on treatment group and baseline value of outcome. P (2-sided) were determined from a Wald-Chi-Square test.||2.24|-6.20|0.36
72422632|NCT03587142|144356343|SUPERIORITY||Mean Difference (Net)|-2.07||||0.15|TWO_SIDED|95.0|-4.91|0.76||P value is nominal; no adjustments made for multiple comparisons Bonferroni p-value is \<0.002|ANCOVA|||Adjusted mean difference of differences (DoD) from baseline were computed using ANCOVA, regressing change from baseline to 4-weeks on treatment group and baseline value of the outcome. Wald 95% Confidence Limits (CI) are reported; P (2-sided) determined from a Wald Chi-Square test.||0.76|-4.91|0.15
72422633|NCT03587142|144356344|SUPERIORITY||Mean Difference (Net)|1.37||||0.76|TWO_SIDED|95.0|-7.51|10.25||P value is nominal: no adjustments made for multiple comparisons. Bonferrini p-value is \<0.002|ANCOVA|||Adjusted mean difference of differences (DoD) from baseline were computed using ANCOVA regressing change from baseline to 4-weeks on treatment group and baseline value of the outcome. Wald 95% Confidence Intervals are reported. P (2-sided) determined from a Wald Chi-Square test.||10.25|-7.51|0.76
72422634|NCT03587142|144356345|SUPERIORITY||Mean Difference (Net)|-0.05||||0.1|TWO_SIDED|95.0|-0.12|0.01||Nominal P values; no adjustment for multiple comparisons.|ANCOVA|||Adjusted mean difference of differences (DoD) were computed using ANCOVA, regressing change in IMD from baseline to 4-weeks on treatment group and the baseline value of IMD. Wald 95% Confidence Intervals are reported; P (2-sided) determined from a Wald Chi-Square test.||0.01|-0.12|0.10
72422635|NCT03587142|144356346|SUPERIORITY||Mean Difference (Net)|-21.51||||0.29|TWO_SIDED|95.0|-99.4|56.4||Nominal P values; no adjustments for multiple comparisons.|ANCOVA|||Adjusted mean difference of differences (DoD) from baseline were computed using ANCOVA, regressing change from baseline to 4-weeks on treatment group and baseline value of teh outcome. Wald 95% Confidence Limits are reported; P (2-sided) determined from a Wald Chi-Square test.||56.4|-99.4|0.29
72331478|NCT01942668|144188358|SUPERIORITY|||||||0.012||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo during Trimester 1|Fisher Exact|||||||0.012
72331479|NCT01942668|144188358|SUPERIORITY|||||||0.032||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo during Trimester 1|Fisher Exact|||||||0.032
72331480|NCT01942668|144188359|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo during Trimester 2|Fisher Exact|||||||<0.001
72331481|NCT01942668|144188359|SUPERIORITY|||||||0.022||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo during Trimester 2|Fisher Exact|||||||0.022
72331482|NCT01942668|144188359|SUPERIORITY|||||||0.004||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo during Trimester 2|Fisher Exact|||||||0.004
72331483|NCT01942668|144188359|SUPERIORITY|||||||0.256||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo during Trimester 2|Fisher Exact|||||||0.256
72331484|NCT01942668|144188360|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo during Trimester 3|Fisher Exact|||||||<0.001
72331485|NCT01942668|144188360|SUPERIORITY|||||||0.006||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo during Trimester 3|Fisher Exact|||||||0.006
72331486|NCT01942668|144188360|SUPERIORITY|||||||0.025||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo during Trimester 3|Fisher Exact|||||||0.025
72331487|NCT01942668|144188360|SUPERIORITY|||||||0.182||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo during Trimester 3|Fisher Exact|||||||0.182
72331488|NCT01942668|144188361|SUPERIORITY|||||||0.002||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo during Trimester 4|Fisher Exact|||||||0.002
72331489|NCT01942668|144188361|SUPERIORITY|||||||0.469||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo during Trimester 4|Fisher Exact|||||||0.469
72331490|NCT01942668|144188361|SUPERIORITY|||||||0.188||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo during Trimester 4|Fisher Exact|||||||0.188
72331491|NCT01942668|144188361|SUPERIORITY|||||||0.613||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo during Trimester 4|Fisher Exact|||||||0.613
72331492|NCT01942668|144188366|SUPERIORITY|||||||0.002||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo during Trimester 1|Fisher Exact|||||||0.002
72331493|NCT01942668|144188366|SUPERIORITY|||||||0.135||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo during Trimester 1|Fisher Exact|||||||0.135
72331494|NCT01942668|144188366|SUPERIORITY|||||||0.26||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo during Trimester 1|Fisher Exact|||||||0.260
72331495|NCT01942668|144188366|SUPERIORITY|||||||0.257||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo during Trimester 1|Fisher Exact|||||||0.257
72331496|NCT01942668|144188367|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo during Trimester 2|Fisher Exact|||||||<0.001
72331497|NCT01942668|144188367|SUPERIORITY|||||||0.085||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo during Trimester 2|Fisher Exact|||||||0.085
72331498|NCT01942668|144188367|SUPERIORITY|||||||0.184||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo during Trimester 2|Fisher Exact|||||||0.184
72331499|NCT01942668|144188367|SUPERIORITY|||||||0.681||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo during Trimester 2|Fisher Exact|||||||0.681
72331500|NCT01942668|144188368|SUPERIORITY|||||||0.008||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo during Trimester 3|Fisher Exact|||||||0.008
72331501|NCT01942668|144188368|SUPERIORITY|||||||0.036||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo during Trimester 3|Fisher Exact|||||||0.036
72331502|NCT01942668|144188368|SUPERIORITY|||||||0.138||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo during Trimester 3|Fisher Exact|||||||0.138
72331503|NCT01942668|144188368|SUPERIORITY|||||||0.685||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo during Trimester 3|Fisher Exact|||||||0.685
72331504|NCT01942668|144188369|SUPERIORITY|||||||0.023||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo during Trimester 4|Fisher Exact|||||||0.023
72331505|NCT01942668|144188369|SUPERIORITY|||||||0.265||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo during Trimester 4|Fisher Exact|||||||0.265
72331506|NCT01942668|144188369|SUPERIORITY|||||||1||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo during Trimester 4|Fisher Exact|||||||1.000
72331507|NCT01942668|144188369|SUPERIORITY|||||||1||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo during Trimester 4|Fisher Exact|||||||1.000
72331508|NCT01942668|144188374|SUPERIORITY||Mean Difference (Final Values)|-1.65|STANDARD_ERROR_OF_MEAN|0.246|<|0.001|TWO_SIDED|95.0|-2.13|-1.17||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||-1.17|-2.13|<0.001
72331509|NCT01942668|144188374|SUPERIORITY||Mean Difference (Final Values)|-1.31|STANDARD_ERROR_OF_MEAN|0.242|<|0.001|TWO_SIDED|95.0|-1.79|-0.84||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||-0.84|-1.79|<0.001
72331510|NCT01942668|144188374|SUPERIORITY||Mean Difference (Final Values)|-1.17|STANDARD_ERROR_OF_MEAN|0.242|<|0.001|TWO_SIDED|95.0|-1.64|-0.69||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||-0.69|-1.64|<0.001
72331511|NCT01942668|144188374|SUPERIORITY||Mean Difference (Final Values)|-1.04|STANDARD_ERROR_OF_MEAN|0.238|<|0.001|TWO_SIDED|95.0|-1.51|-0.58||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||-0.58|-1.51|<0.001
72331512|NCT01942668|144188375|SUPERIORITY||Mean Difference (Final Values)|-1.4|STANDARD_ERROR_OF_MEAN|0.258|<|0.001|TWO_SIDED|95.0|-1.91|-0.89||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||-0.89|-1.91|<0.001
72331513|NCT01942668|144188375|SUPERIORITY||Mean Difference (Final Values)|-1.32|STANDARD_ERROR_OF_MEAN|0.253|<|0.001|TWO_SIDED|95.0|-1.81|-0.82||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||-0.82|-1.81|<0.001
72331514|NCT01942668|144188375|SUPERIORITY||Mean Difference (Final Values)|-1.12|STANDARD_ERROR_OF_MEAN|0.257|<|0.001|TWO_SIDED|95.0|-1.63|-0.62||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||-0.62|-1.63|<0.001
72331515|NCT01942668|144188375|SUPERIORITY||Mean Difference (Final Values)|-0.69|STANDARD_ERROR_OF_MEAN|0.254||0.007|TWO_SIDED|95.0|-1.19|-0.19||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||-0.19|-1.19|0.007
72331516|NCT01942668|144188376|SUPERIORITY||Mean Difference (Final Values)|-1.2|STANDARD_ERROR_OF_MEAN|0.276|<|0.001|TWO_SIDED|95.0|-1.75|-0.66||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||-0.66|-1.75|<0.001
72331517|NCT01942668|144188376|SUPERIORITY||Mean Difference (Final Values)|-1.46|STANDARD_ERROR_OF_MEAN|0.265|<|0.001|TWO_SIDED|95.0|-1.98|-0.94||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||-0.94|-1.98|<0.001
72331518|NCT01942668|144188376|SUPERIORITY||Mean Difference (Final Values)|-1.23|STANDARD_ERROR_OF_MEAN|0.272|<|0.001|TWO_SIDED|95.0|-1.76|-0.69||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||-0.69|-1.76|<0.001
72331519|NCT01942668|144188376|SUPERIORITY||Mean Difference (Final Values)|-0.72|STANDARD_ERROR_OF_MEAN|0.272||0.008|TWO_SIDED|95.0|-1.26|-0.19||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||-0.19|-1.26|0.008
72331520|NCT01942668|144188377|SUPERIORITY||Mean Difference (Final Values)|-0.17|STANDARD_ERROR_OF_MEAN|0.161||0.284|TWO_SIDED|95.0|-0.49|0.14||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||0.14|-0.49|0.284
72331521|NCT01942668|144188377|SUPERIORITY||Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.158||0.732|TWO_SIDED|95.0|-0.36|0.26||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||0.26|-0.36|0.732
72331522|NCT01942668|144188377|SUPERIORITY||Mean Difference (Final Values)|-0.12|STANDARD_ERROR_OF_MEAN|0.159||0.437|TWO_SIDED|95.0|-0.44|0.19||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||0.19|-0.44|0.437
72331523|NCT01942668|144188377|SUPERIORITY||Mean Difference (Final Values)|-0.12|STANDARD_ERROR_OF_MEAN|0.156||0.439|TWO_SIDED|95.0|-0.43|0.19||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||0.19|-0.43|0.439
72331524|NCT01942668|144188378|SUPERIORITY||Mean Difference (Final Values)|-0.35|STANDARD_ERROR_OF_MEAN|0.169||0.04|TWO_SIDED|95.0|-0.68|-0.02||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||-0.02|-0.68|0.040
72331525|NCT01942668|144188378|SUPERIORITY||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.165||0.066|TWO_SIDED|95.0|-0.63|0.02||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||0.02|-0.63|0.066
72331526|NCT01942668|144188378|SUPERIORITY||Mean Difference (Final Values)|-0.12|STANDARD_ERROR_OF_MEAN|0.168||0.469|TWO_SIDED|95.0|-0.45|0.21||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||0.21|-0.45|0.469
72331527|NCT01942668|144188378|SUPERIORITY||Mean Difference (Final Values)|-0.08|STANDARD_ERROR_OF_MEAN|0.166||0.616|TWO_SIDED|95.0|-0.41|0.24||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||0.24|-0.41|0.616
72331528|NCT01942668|144188379|SUPERIORITY||Mean Difference (Final Values)|-0.21|STANDARD_ERROR_OF_MEAN|0.183||0.25|TWO_SIDED|95.0|-0.57|0.15||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||0.15|-0.57|0.250
72331529|NCT01942668|144188379|SUPERIORITY||Mean Difference (Final Values)|-0.54|STANDARD_ERROR_OF_MEAN|0.175||0.002|TWO_SIDED|95.0|-0.88|-0.2||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||-0.20|-0.88|0.002
72331530|NCT01942668|144188379|SUPERIORITY||Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.179||0.796|TWO_SIDED|95.0|-0.4|0.31||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||0.31|-0.40|0.796
72331531|NCT01942668|144188379|SUPERIORITY||Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.179||0.955|TWO_SIDED|95.0|-0.36|0.34||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||0.34|-0.36|0.955
72331532|NCT01942668|144188380|SUPERIORITY||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.143||0.474|TWO_SIDED|95.0|-0.38|0.18||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||0.18|-0.38|0.474
72331533|NCT01942668|144188380|SUPERIORITY||Mean Difference (Final Values)|-0.12|STANDARD_ERROR_OF_MEAN|0.14||0.378|TWO_SIDED|95.0|-0.4|0.15||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||0.15|-0.40|0.378
72331534|NCT01942668|144188380|SUPERIORITY||Mean Difference (Final Values)|-0.33|STANDARD_ERROR_OF_MEAN|0.141||0.018|TWO_SIDED|95.0|-0.61|-0.06||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||-0.06|-0.61|0.018
72331535|NCT01942668|144188380|SUPERIORITY||Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.138||0.73|TWO_SIDED|95.0|-0.32|0.22||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||0.22|-0.32|0.730
72331536|NCT01942668|144188381|SUPERIORITY||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.152||0.197|TWO_SIDED|95.0|-0.49|0.1||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||0.10|-0.49|0.197
72331537|NCT01942668|144188381|SUPERIORITY||Mean Difference (Final Values)|-0.15|STANDARD_ERROR_OF_MEAN|0.148||0.308|TWO_SIDED|95.0|-0.44|0.14||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||0.14|-0.44|0.308
72331538|NCT01942668|144188381|SUPERIORITY||Mean Difference (Final Values)|-0.24|STANDARD_ERROR_OF_MEAN|0.152||0.117|TWO_SIDED|95.0|-0.54|0.06||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||0.06|-0.54|0.117
72331539|NCT01942668|144188381|SUPERIORITY||Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.149||0.739|TWO_SIDED|95.0|-0.34|0.24||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||0.24|-0.34|0.739
72331540|NCT01942668|144188382|SUPERIORITY||Mean Difference (Final Values)|-0.08|STANDARD_ERROR_OF_MEAN|0.171||0.635|TWO_SIDED|95.0|-0.42|0.26||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||0.26|-0.42|0.635
72331541|NCT01942668|144188382|SUPERIORITY||Mean Difference (Final Values)|-0.43|STANDARD_ERROR_OF_MEAN|0.164||0.01|TWO_SIDED|95.0|-0.75|-0.1||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||-0.10|-0.75|0.010
72331542|NCT01942668|144188382|SUPERIORITY||Mean Difference (Final Values)|-0.28|STANDARD_ERROR_OF_MEAN|0.169||0.092|TWO_SIDED|95.0|-0.62|0.05||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||0.05|-0.62|0.092
72331543|NCT01942668|144188382|SUPERIORITY||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.168||0.243|TWO_SIDED|95.0|-0.53|0.13||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||0.13|-0.53|0.243
72331544|NCT01942668|144188383|SUPERIORITY||Mean Difference (Final Values)|-0.41|STANDARD_ERROR_OF_MEAN|0.21||0.049|TWO_SIDED|95.0|-0.83|0.0||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||-0.00|-0.83|0.049
72331545|NCT01942668|144188383|SUPERIORITY||Mean Difference (Final Values)|0.06|STANDARD_ERROR_OF_MEAN|0.206||0.773|TWO_SIDED|95.0|-0.34|0.46||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||0.46|-0.34|0.773
72331546|NCT01942668|144188383|SUPERIORITY||Mean Difference (Final Values)|-0.36|STANDARD_ERROR_OF_MEAN|0.208||0.081|TWO_SIDED|95.0|-0.77|0.05||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||0.05|-0.77|0.081
72331547|NCT01942668|144188383|SUPERIORITY||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.204||0.625|TWO_SIDED|95.0|-0.5|0.3||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||0.30|-0.50|0.625
72331548|NCT01942668|144188384|SUPERIORITY||Mean Difference (Final Values)|-0.27|STANDARD_ERROR_OF_MEAN|0.221||0.221|TWO_SIDED|95.0|-0.7|0.16||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||0.16|-0.70|0.221
72331549|NCT01942668|144188384|SUPERIORITY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.214||0.992|TWO_SIDED|95.0|-0.42|0.42||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||0.42|-0.42|0.992
72331550|NCT01942668|144188384|SUPERIORITY||Mean Difference (Final Values)|-0.29|STANDARD_ERROR_OF_MEAN|0.219||0.181|TWO_SIDED|95.0|-0.72|0.14||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||0.14|-0.72|0.181
72331551|NCT01942668|144188384|SUPERIORITY||Mean Difference (Final Values)|-0.04|STANDARD_ERROR_OF_MEAN|0.216||0.846|TWO_SIDED|95.0|-0.47|0.38||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||0.38|-0.47|0.846
72331552|NCT01942668|144188385|SUPERIORITY||Mean Difference (Final Values)|-0.21|STANDARD_ERROR_OF_MEAN|0.257||0.421|TWO_SIDED|95.0|-0.71|0.3||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||0.30|-0.71|0.421
72331553|NCT01942668|144188385|SUPERIORITY||Mean Difference (Final Values)|-0.49|STANDARD_ERROR_OF_MEAN|0.244||0.044|TWO_SIDED|95.0|-0.97|-0.01||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||-0.01|-0.97|0.044
72331554|NCT01942668|144188385|SUPERIORITY||Mean Difference (Final Values)|-0.42|STANDARD_ERROR_OF_MEAN|0.252||0.093|TWO_SIDED|95.0|-0.92|0.07||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||0.07|-0.92|0.093
72331555|NCT01942668|144188385|SUPERIORITY||Mean Difference (Final Values)|-0.29|STANDARD_ERROR_OF_MEAN|0.252||0.247|TWO_SIDED|95.0|-0.79|0.2||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||0.20|-0.79|0.247
72331556|NCT01942668|144188386|SUPERIORITY||Mean Difference (Final Values)|-0.58|STANDARD_ERROR_OF_MEAN|0.145|<|0.001|TWO_SIDED|95.0|-0.87|-0.29||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||-0.29|-0.87|<0.001
72331557|NCT01942668|144188386|SUPERIORITY||Mean Difference (Final Values)|-0.34|STANDARD_ERROR_OF_MEAN|0.143||0.016|TWO_SIDED|95.0|-0.62|-0.06||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||-0.06|-0.62|0.016
72331558|NCT01942668|144188386|SUPERIORITY||Mean Difference (Final Values)|-0.48|STANDARD_ERROR_OF_MEAN|0.143|<|0.001|TWO_SIDED|95.0|-0.76|-0.2||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||-0.20|-0.76|<0.001
72331559|NCT01942668|144188386|SUPERIORITY||Mean Difference (Final Values)|-0.32|STANDARD_ERROR_OF_MEAN|0.141||0.023|TWO_SIDED|95.0|-0.6|-0.05||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||-0.05|-0.60|0.023
72331560|NCT01942668|144188387|SUPERIORITY||Mean Difference (Final Values)|-0.55|STANDARD_ERROR_OF_MEAN|0.15|<|0.001|TWO_SIDED|95.0|-0.84|-0.25||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||-0.25|-0.84|<0.001
72331561|NCT01942668|144188387|SUPERIORITY||Mean Difference (Final Values)|-0.42|STANDARD_ERROR_OF_MEAN|0.146||0.004|TWO_SIDED|95.0|-0.71|-0.13||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||-0.13|-0.71|0.004
72331562|NCT01942668|144188387|SUPERIORITY||Mean Difference (Final Values)|-0.44|STANDARD_ERROR_OF_MEAN|0.149||0.003|TWO_SIDED|95.0|-0.73|-0.14||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||-0.14|-0.73|0.003
72331563|NCT01942668|144188387|SUPERIORITY||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.147||0.179|TWO_SIDED|95.0|-0.49|0.09||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||0.09|-0.49|0.179
72331564|NCT01942668|144188388|SUPERIORITY||Mean Difference (Final Values)|-0.43|STANDARD_ERROR_OF_MEAN|0.169||0.012|TWO_SIDED|95.0|-0.76|-0.1||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||-0.10|-0.76|0.012
72331565|NCT01942668|144188388|SUPERIORITY||Mean Difference (Final Values)|-0.73|STANDARD_ERROR_OF_MEAN|0.162|<|0.001|TWO_SIDED|95.0|-1.05|-0.41||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||-0.41|-1.05|<0.001
72331566|NCT01942668|144188388|SUPERIORITY||Mean Difference (Final Values)|-0.49|STANDARD_ERROR_OF_MEAN|0.166||0.004|TWO_SIDED|95.0|-0.81|-0.16||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||-0.16|-0.81|0.004
72331567|NCT01942668|144188388|SUPERIORITY||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.166||0.07|TWO_SIDED|95.0|-0.63|0.03||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||0.03|-0.63|0.070
72331568|NCT01942668|144188389|SUPERIORITY||Mean Difference (Final Values)|-4.39|STANDARD_ERROR_OF_MEAN|2.059||0.033|TWO_SIDED|95.0|-8.44|-0.35||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||-0.35|-8.44|0.033
72331569|NCT01942668|144188389|SUPERIORITY||Mean Difference (Final Values)|-2.54|STANDARD_ERROR_OF_MEAN|2.015||0.207|TWO_SIDED|95.0|-6.5|1.41||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||1.41|-6.50|0.207
72331570|NCT01942668|144188389|SUPERIORITY||Mean Difference (Final Values)|-4.6|STANDARD_ERROR_OF_MEAN|2.03||0.024|TWO_SIDED|95.0|-8.58|-0.61||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||-0.61|-8.58|0.024
72331571|NCT01942668|144188389|SUPERIORITY||Mean Difference (Final Values)|-2.53|STANDARD_ERROR_OF_MEAN|2.007||0.207|TWO_SIDED|95.0|-6.47|1.41||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||1.41|-6.47|0.207
72331572|NCT01942668|144188390|SUPERIORITY||Mean Difference (Final Values)|-5.48|STANDARD_ERROR_OF_MEAN|2.138||0.011|TWO_SIDED|95.0|-9.68|-1.28||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||-1.28|-9.68|0.011
72331573|NCT01942668|144188390|SUPERIORITY||Mean Difference (Final Values)|-5.25|STANDARD_ERROR_OF_MEAN|2.093||0.012|TWO_SIDED|95.0|-9.36|-1.14||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||-1.14|-9.36|0.012
72331574|NCT01942668|144188390|SUPERIORITY||Mean Difference (Final Values)|-5.58|STANDARD_ERROR_OF_MEAN|2.122||0.009|TWO_SIDED|95.0|-9.75|-1.41||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||-1.41|-9.75|0.009
72331575|NCT01942668|144188390|SUPERIORITY||Mean Difference (Final Values)|-4.99|STANDARD_ERROR_OF_MEAN|2.096||0.018|TWO_SIDED|95.0|-9.11|-0.87||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||-0.87|-9.11|0.018
72331576|NCT01942668|144188391|SUPERIORITY||Mean Difference (Final Values)|-4.61|STANDARD_ERROR_OF_MEAN|2.427||0.058|TWO_SIDED|95.0|-9.38|0.16||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||0.16|-9.38|0.058
72331577|NCT01942668|144188391|SUPERIORITY||Mean Difference (Final Values)|-7.48|STANDARD_ERROR_OF_MEAN|2.322||0.001|TWO_SIDED|95.0|-12.04|-2.92||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||-2.92|-12.04|0.001
72331578|NCT01942668|144188391|SUPERIORITY||Mean Difference (Final Values)|-7.96|STANDARD_ERROR_OF_MEAN|2.397|<|0.001|TWO_SIDED|95.0|-12.67|-3.25||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||-3.25|-12.67|<0.001
72331579|NCT01942668|144188391|SUPERIORITY||Mean Difference (Final Values)|-6.78|STANDARD_ERROR_OF_MEAN|2.404||0.005|TWO_SIDED|95.0|-11.5|-2.06||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||-2.06|-11.50|0.005
72331580|NCT01942668|144188392|SUPERIORITY||Mean Difference (Final Values)|-6.48|STANDARD_ERROR_OF_MEAN|2.77||0.02|TWO_SIDED|95.0|-11.92|-1.04||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||-1.04|-11.92|0.020
72331581|NCT01942668|144188392|SUPERIORITY||Mean Difference (Final Values)|-3.36|STANDARD_ERROR_OF_MEAN|2.715||0.216|TWO_SIDED|95.0|-8.69|1.97||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||1.97|-8.69|0.216
72331582|NCT01942668|144188392|SUPERIORITY||Mean Difference (Final Values)|-5.85|STANDARD_ERROR_OF_MEAN|2.734||0.033|TWO_SIDED|95.0|-11.22|-0.48||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||-0.48|-11.22|0.033
72331583|NCT01942668|144188392|SUPERIORITY||Mean Difference (Final Values)|-2.99|STANDARD_ERROR_OF_MEAN|2.685||0.265|TWO_SIDED|95.0|-8.27|2.28||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||2.28|-8.27|0.265
72331584|NCT01942668|144188393|SUPERIORITY||Mean Difference (Final Values)|-7.54|STANDARD_ERROR_OF_MEAN|2.854||0.008|TWO_SIDED|95.0|-13.14|-1.93||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||-1.93|-13.14|0.008
72331585|NCT01942668|144188393|SUPERIORITY||Mean Difference (Final Values)|-6.72|STANDARD_ERROR_OF_MEAN|2.781||0.016|TWO_SIDED|95.0|-12.18|-1.26||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||-1.26|-12.18|0.016
72331586|NCT01942668|144188393|SUPERIORITY||Mean Difference (Final Values)|-8.69|STANDARD_ERROR_OF_MEAN|2.847||0.002|TWO_SIDED|95.0|-14.28|-3.1||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||-3.10|-14.28|0.002
72331587|NCT01942668|144188393|SUPERIORITY||Mean Difference (Final Values)|-6.18|STANDARD_ERROR_OF_MEAN|2.8||0.028|TWO_SIDED|95.0|-11.68|-0.68||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||-0.68|-11.68|0.028
72331588|NCT01942668|144188394|SUPERIORITY||Mean Difference (Final Values)|-6.56|STANDARD_ERROR_OF_MEAN|3.18||0.04|TWO_SIDED|95.0|-12.8|-0.31||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||-0.31|-12.80|0.040
72331589|NCT01942668|144188394|SUPERIORITY||Mean Difference (Final Values)|-10.02|STANDARD_ERROR_OF_MEAN|3.04||0.001|TWO_SIDED|95.0|-15.99|-4.04||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||-4.04|-15.99|0.001
72331590|NCT01942668|144188394|SUPERIORITY||Mean Difference (Final Values)|-9.96|STANDARD_ERROR_OF_MEAN|3.129||0.002|TWO_SIDED|95.0|-16.11|-3.81||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||-3.81|-16.11|0.002
72331591|NCT01942668|144188394|SUPERIORITY||Mean Difference (Final Values)|-6.85|STANDARD_ERROR_OF_MEAN|3.127||0.029|TWO_SIDED|95.0|-12.99|-0.7||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||-0.70|-12.99|0.029
72331592|NCT01942668|144188395|SUPERIORITY||Mean Difference (Final Values)|3.15|STANDARD_ERROR_OF_MEAN|3.003||0.294|TWO_SIDED|95.0|-2.75|9.05||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||9.05|-2.75|0.294
72331593|NCT01942668|144188395|SUPERIORITY||Mean Difference (Final Values)|2.86|STANDARD_ERROR_OF_MEAN|2.922||0.327|TWO_SIDED|95.0|-2.87|8.6||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||8.60|-2.87|0.327
72331594|NCT01942668|144188395|SUPERIORITY||Mean Difference (Final Values)|-1.39|STANDARD_ERROR_OF_MEAN|2.947||0.637|TWO_SIDED|95.0|-7.18|4.39||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||4.39|-7.18|0.637
72331595|NCT01942668|144188395|SUPERIORITY||Mean Difference (Final Values)|0.17|STANDARD_ERROR_OF_MEAN|2.893||0.952|TWO_SIDED|95.0|-5.51|5.86||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||5.86|-5.51|0.952
72331596|NCT01942668|144188396|SUPERIORITY||Mean Difference (Final Values)|1.82|STANDARD_ERROR_OF_MEAN|3.219||0.573|TWO_SIDED|95.0|-4.51|8.14||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||8.14|-4.51|0.573
72422636|NCT03587142|144356347|SUPERIORITY||Mean Difference (Net)|0.09||||0.84|TWO_SIDED|95.0|-0.78|0.95||P value is nominal; no adjustments made for multiple comparisons. Bonferroni p-value \<0.002|ANCOVA|||Adjusted mean difference of differences (DoD) from baseline were computed using ANCOVA, regressing change from baseline to week 4 on treatment group and baseline value of the outcome. Wald 95% Confidence Limits (CI) are reported: P (2-sided) determined from Wald Chi-Square test.||0.95|-0.78|0.84
72331597|NCT01942668|144188396|SUPERIORITY||Mean Difference (Final Values)|-0.91|STANDARD_ERROR_OF_MEAN|3.107||0.769|TWO_SIDED|95.0|-7.01|5.19||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||5.19|-7.01|0.769
72331598|NCT01942668|144188396|SUPERIORITY||Mean Difference (Final Values)|-6.33|STANDARD_ERROR_OF_MEAN|3.176||0.047|TWO_SIDED|95.0|-12.56|-0.09||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||-0.09|-12.56|0.047
72422637|NCT03587142|144356348|SUPERIORITY||Mean Difference (Net)|-6.43||||0.27|TWO_SIDED|95.0|-17.9|5.03||P value is nominal|ANCOVA|||Adjusted mean difference of differences (DoD) from baseline were computed using ANCOVA, regressing change from baseline to 4-weeks on treatment group and baseline value of the outcome. Wald 95% Confidence Limits (CI) are reported; P (2-sided) determined from a Wald Chi-Square test.||5.03|-17.90|0.27
72331599|NCT01942668|144188396|SUPERIORITY||Mean Difference (Final Values)|-2.59|STANDARD_ERROR_OF_MEAN|3.133||0.409|TWO_SIDED|95.0|-8.74|3.56||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||3.56|-8.74|0.409
72331600|NCT01942668|144188397|SUPERIORITY||Mean Difference (Final Values)|1.91|STANDARD_ERROR_OF_MEAN|3.443||0.579|TWO_SIDED|95.0|-4.85|8.67||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||8.67|-4.85|0.579
72331601|NCT01942668|144188397|SUPERIORITY||Mean Difference (Final Values)|-3.99|STANDARD_ERROR_OF_MEAN|3.275||0.223|TWO_SIDED|95.0|-10.43|2.44||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||2.44|-10.43|0.223
72331602|NCT01942668|144188397|SUPERIORITY||Mean Difference (Final Values)|-2.05|STANDARD_ERROR_OF_MEAN|3.367||0.542|TWO_SIDED|95.0|-8.67|4.56||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||4.56|-8.67|0.542
72331603|NCT01942668|144188397|SUPERIORITY||Mean Difference (Final Values)|-2.41|STANDARD_ERROR_OF_MEAN|3.376||0.476|TWO_SIDED|95.0|-9.04|4.23||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||4.23|-9.04|0.476
72331604|NCT01942668|144188398|SUPERIORITY||Mean Difference (Final Values)|-1.25|STANDARD_ERROR_OF_MEAN|2.593||0.631|TWO_SIDED|95.0|-6.34|3.84||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||3.84|-6.34|0.631
72331605|NCT01942668|144188398|SUPERIORITY||Mean Difference (Final Values)|1.15|STANDARD_ERROR_OF_MEAN|2.54||0.651|TWO_SIDED|95.0|-3.84|6.14||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||6.14|-3.84|0.651
72331606|NCT01942668|144188398|SUPERIORITY||Mean Difference (Final Values)|-0.61|STANDARD_ERROR_OF_MEAN|2.578||0.813|TWO_SIDED|95.0|-5.67|4.45||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||4.45|-5.67|0.813
72331607|NCT01942668|144188398|SUPERIORITY||Mean Difference (Final Values)|-0.42|STANDARD_ERROR_OF_MEAN|2.515||0.869|TWO_SIDED|95.0|-5.35|4.52||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||4.52|-5.35|0.869
72331608|NCT01942668|144188399|SUPERIORITY||Mean Difference (Final Values)|-5.0|STANDARD_ERROR_OF_MEAN|2.79||0.074|TWO_SIDED|95.0|-10.48|0.48||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||0.48|-10.48|0.074
72331609|NCT01942668|144188399|SUPERIORITY||Mean Difference (Final Values)|-0.87|STANDARD_ERROR_OF_MEAN|2.722||0.748|TWO_SIDED|95.0|-6.22|4.47||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||4.47|-6.22|0.748
72331610|NCT01942668|144188399|SUPERIORITY||Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|2.805||0.987|TWO_SIDED|95.0|-5.46|5.56||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||5.56|-5.46|0.987
72331611|NCT01942668|144188399|SUPERIORITY||Mean Difference (Final Values)|-1.02|STANDARD_ERROR_OF_MEAN|2.741||0.709|TWO_SIDED|95.0|-6.41|4.36||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||4.36|-6.41|0.709
72331612|NCT01942668|144188400|SUPERIORITY||Mean Difference (Final Values)|-2.61|STANDARD_ERROR_OF_MEAN|2.968||0.379|TWO_SIDED|95.0|-8.44|3.22||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||3.22|-8.44|0.379
72331613|NCT01942668|144188400|SUPERIORITY||Mean Difference (Final Values)|-3.07|STANDARD_ERROR_OF_MEAN|2.832||0.279|TWO_SIDED|95.0|-8.64|2.49||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||2.49|-8.64|0.279
72331614|NCT01942668|144188400|SUPERIORITY||Mean Difference (Final Values)|-0.39|STANDARD_ERROR_OF_MEAN|2.949||0.894|TWO_SIDED|95.0|-6.19|5.4||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||5.40|-6.19|0.894
72331615|NCT01942668|144188400|SUPERIORITY||Mean Difference (Final Values)|-2.98|STANDARD_ERROR_OF_MEAN|2.923||0.308|TWO_SIDED|95.0|-8.72|2.76||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||2.76|-8.72|0.308
72331616|NCT01942668|144188401|SUPERIORITY||Mean Difference (Final Values)|1.81|STANDARD_ERROR_OF_MEAN|3.081||0.558|TWO_SIDED|95.0|-4.24|7.86||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||7.86|-4.24|0.558
72331617|NCT01942668|144188401|SUPERIORITY||Mean Difference (Final Values)|3.61|STANDARD_ERROR_OF_MEAN|3.031||0.233|TWO_SIDED|95.0|-2.34|9.57||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||9.57|-2.34|0.233
72331618|NCT01942668|144188401|SUPERIORITY||Mean Difference (Final Values)|6.16|STANDARD_ERROR_OF_MEAN|3.036||0.043|TWO_SIDED|95.0|0.2|12.13||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||12.13|0.20|0.043
72331619|NCT01942668|144188401|SUPERIORITY||Mean Difference (Final Values)|2.07|STANDARD_ERROR_OF_MEAN|2.99||0.488|TWO_SIDED|95.0|-3.8|7.95||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||7.95|-3.80|0.488
72331620|NCT01942668|144188402|SUPERIORITY||Mean Difference (Final Values)|4.07|STANDARD_ERROR_OF_MEAN|3.206||0.205|TWO_SIDED|95.0|-2.23|10.37||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||10.37|-2.23|0.205
72331621|NCT01942668|144188402|SUPERIORITY||Mean Difference (Final Values)|9.58|STANDARD_ERROR_OF_MEAN|3.133||0.002|TWO_SIDED|95.0|3.43|15.74||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||15.74|3.43|0.002
72331622|NCT01942668|144188402|SUPERIORITY||Mean Difference (Final Values)|5.04|STANDARD_ERROR_OF_MEAN|3.193||0.115|TWO_SIDED|95.0|-1.23|11.32||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||11.32|-1.23|0.115
72331623|NCT01942668|144188402|SUPERIORITY||Mean Difference (Final Values)|8.94|STANDARD_ERROR_OF_MEAN|3.152||0.005|TWO_SIDED|95.0|2.75|15.13||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||15.13|2.75|0.005
72331624|NCT01942668|144188403|SUPERIORITY||Mean Difference (Final Values)|0.96|STANDARD_ERROR_OF_MEAN|3.719||0.796|TWO_SIDED|95.0|-6.34|8.27||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||8.27|-6.34|0.796
72331625|NCT01942668|144188403|SUPERIORITY||Mean Difference (Final Values)|5.14|STANDARD_ERROR_OF_MEAN|3.568||0.15|TWO_SIDED|95.0|-1.87|12.15||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||12.15|-1.87|0.150
72331626|NCT01942668|144188403|SUPERIORITY||Mean Difference (Final Values)|8.58|STANDARD_ERROR_OF_MEAN|3.657||0.019|TWO_SIDED|95.0|1.39|15.77||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||15.77|1.39|0.019
72331627|NCT01942668|144188403|SUPERIORITY||Mean Difference (Final Values)|7.51|STANDARD_ERROR_OF_MEAN|3.667||0.041|TWO_SIDED|95.0|0.3|14.71||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||14.71|0.30|0.041
72331628|NCT01942668|144188404|SUPERIORITY||Mean Difference (Final Values)|-2.69|STANDARD_ERROR_OF_MEAN|2.197||0.221|TWO_SIDED|95.0|-7.0|1.62||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||1.62|-7.00|0.221
72331629|NCT01942668|144188404|SUPERIORITY||Mean Difference (Final Values)|-1.42|STANDARD_ERROR_OF_MEAN|2.154||0.511|TWO_SIDED|95.0|-5.65|2.81||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||2.81|-5.65|0.511
72331630|NCT01942668|144188404|SUPERIORITY||Mean Difference (Final Values)|0.66|STANDARD_ERROR_OF_MEAN|2.168||0.761|TWO_SIDED|95.0|-3.6|4.92||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||4.92|-3.60|0.761
72331631|NCT01942668|144188404|SUPERIORITY||Mean Difference (Final Values)|-2.07|STANDARD_ERROR_OF_MEAN|2.128||0.332|TWO_SIDED|95.0|-6.25|2.11||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||2.11|-6.25|0.332
72331632|NCT01942668|144188405|SUPERIORITY||Mean Difference (Final Values)|-1.0|STANDARD_ERROR_OF_MEAN|2.474||0.687|TWO_SIDED|95.0|-5.86|3.86||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||3.86|-5.86|0.687
72331633|NCT01942668|144188405|SUPERIORITY||Mean Difference (Final Values)|-2.15|STANDARD_ERROR_OF_MEAN|2.411||0.373|TWO_SIDED|95.0|-6.88|2.58||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||2.58|-6.88|0.373
72331634|NCT01942668|144188405|SUPERIORITY||Mean Difference (Final Values)|-0.91|STANDARD_ERROR_OF_MEAN|2.466||0.714|TWO_SIDED|95.0|-5.75|3.94||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||3.94|-5.75|0.714
72331635|NCT01942668|144188405|SUPERIORITY||Mean Difference (Final Values)|-0.9|STANDARD_ERROR_OF_MEAN|2.427||0.711|TWO_SIDED|95.0|-5.67|3.87||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||3.87|-5.67|0.711
72331636|NCT01942668|144188406|SUPERIORITY||Mean Difference (Final Values)|-2.19|STANDARD_ERROR_OF_MEAN|2.682||0.415|TWO_SIDED|95.0|-7.46|3.08||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||3.08|-7.46|0.415
72331637|NCT01942668|144188406|SUPERIORITY||Mean Difference (Final Values)|-6.01|STANDARD_ERROR_OF_MEAN|2.564||0.019|TWO_SIDED|95.0|-11.04|-0.97||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||-0.97|-11.04|0.019
72331638|NCT01942668|144188406|SUPERIORITY||Mean Difference (Final Values)|-4.72|STANDARD_ERROR_OF_MEAN|2.639||0.074|TWO_SIDED|95.0|-9.9|0.46||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||0.46|-9.90|0.074
72331639|NCT01942668|144188406|SUPERIORITY||Mean Difference (Final Values)|-5.75|STANDARD_ERROR_OF_MEAN|2.637||0.03|TWO_SIDED|95.0|-10.94|-0.57||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||-0.57|-10.94|0.030
72331640|NCT01942668|144188407|SUPERIORITY||Mean Difference (Final Values)|-3.99|STANDARD_ERROR_OF_MEAN|2.109||0.059|TWO_SIDED|95.0|-8.13|0.16||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||0.16|-8.13|0.059
72331641|NCT01942668|144188407|SUPERIORITY||Mean Difference (Final Values)|-2.57|STANDARD_ERROR_OF_MEAN|2.067||0.215|TWO_SIDED|95.0|-6.63|1.49||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||1.49|-6.63|0.215
72331642|NCT01942668|144188407|SUPERIORITY||Mean Difference (Final Values)|-5.1|STANDARD_ERROR_OF_MEAN|2.084||0.015|TWO_SIDED|95.0|-9.19|-1.0||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||-1.00|-9.19|0.015
72331643|NCT01942668|144188407|SUPERIORITY||Mean Difference (Final Values)|-3.16|STANDARD_ERROR_OF_MEAN|2.042||0.122|TWO_SIDED|95.0|-7.17|0.85||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||0.85|-7.17|0.122
72331644|NCT01942668|144188408|SUPERIORITY||Mean Difference (Final Values)|-5.32|STANDARD_ERROR_OF_MEAN|2.135||0.013|TWO_SIDED|95.0|-9.52|-1.13||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||-1.13|-9.52|0.013
72331645|NCT01942668|144188408|SUPERIORITY||Mean Difference (Final Values)|-5.76|STANDARD_ERROR_OF_MEAN|2.08||0.006|TWO_SIDED|95.0|-9.85|-1.68||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||-1.68|-9.85|0.006
72331646|NCT01942668|144188408|SUPERIORITY||Mean Difference (Final Values)|-5.59|STANDARD_ERROR_OF_MEAN|2.132||0.009|TWO_SIDED|95.0|-9.77|-1.4||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||-1.40|-9.77|0.009
72331647|NCT01942668|144188408|SUPERIORITY||Mean Difference (Final Values)|-5.68|STANDARD_ERROR_OF_MEAN|2.093||0.007|TWO_SIDED|95.0|-9.79|-1.57||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||-1.57|-9.79|0.007
72331648|NCT01942668|144188409|SUPERIORITY||Mean Difference (Final Values)|-3.39|STANDARD_ERROR_OF_MEAN|2.47||0.171|TWO_SIDED|95.0|-8.24|1.47||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||1.47|-8.24|0.171
72331649|NCT01942668|144188409|SUPERIORITY||Mean Difference (Final Values)|-6.49|STANDARD_ERROR_OF_MEAN|2.364||0.006|TWO_SIDED|95.0|-11.14|-1.85||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||-1.85|-11.14|0.006
72422638|NCT03587142|144356349|SUPERIORITY||Mean Difference (Net)|-1.02||||0.74|TWO_SIDED|95.0|-6.93|4.89||P value is nominal: no adjustments made for multiple comparisons. Bonferroni p-value threshold for the level of significance is \<0.002|ANCOVA|||Adjusted mean difference of differences (DoD) from baseline were computed using ANCOVA, regressing change from baseline to 4-weeks on treatment group and baseline value of the outcome. Wald 95% Confidence Intervals are reported; P (2-sided) determined from a Wald Chi-Square test.||4.89|-6.93|0.74
72422639|NCT03587142|144356350|SUPERIORITY||Mean Difference (Net)|0.03||||0.18|TWO_SIDED|95.0|-0.01|0.08|||ANCOVA|P value is nominal: no adjustments made for multiple comparisons. Bonferroni p-value threshold level of significance \<0.002||Adjusted mean difference of differences (DoD) from baseline were computed using ANCOVA, regressing change from baseline to 4-weeks on treatment group and baseline value of the outcome. 95% Wald Confidence Intervals are reported; P (2-sided) determined from a Wald Chi-Square test.||0.08|-0.01|0.18
72422640|NCT03587142|144356351|SUPERIORITY||Mean Difference (Net)|-0.39||||0.97|TWO_SIDED|95.0|-20.42|19.64||P value is nominal: no adjustments made for multiple comparisons. Bonferroni p-value threshold level of significance is \<0.002|ANCOVA|||Adjusted mean difference of differences (DoD) from baseline were computed using ANCOVA, regressing change from baseline to 4-weeks on treatment group and baseline value of the outcome. 95% Wald Confidence Intervals are reported; P (2-sided) determined from a Wald Chi-Square test.||19.64|-20.42|0.97
72422641|NCT03587142|144356352|SUPERIORITY||Incident rate ratio|1.27||||0.64|TWO_SIDED|95.0|0.57|2.82||P values are nominal and not adjusted for multiple comparisons.|Exact poisson regression|||Event rates are computed by treatment arm by dividing the total adverse events over 4-weeks by the number of patient-months of follow-up to 4-weeks. Event rates are compared by treatment arm using an exact poisson regression for event rates.||2.82|0.57|0.64
72422642|NCT03587142|144356353|SUPERIORITY||Incident rate ratio|0.95||||0.54|TWO_SIDED|95.0|0.35|2.62||P values are nominal.|Fisher Exact|||A Fisher's Exact test was used for comparisons of events by treatment by severity grade. One patient in the Buspirone arm had 2 AEs during the trial; for analysis by severity grade the maximum severity grade was used.|An exact poisson regression stratified by severity level was used to compute the incident rate ratio and 95% Confidence Intervals for adverse events by severity level.|2.62|0.35|0.54
72422643|NCT03587142|144356354|SUPERIORITY|||||||1||||||P value is nominal.|Fisher Exact|||||||1.00
72422644|NCT03587142|144356355|SUPERIORITY||Incident rate ratio|1.03||||1|TWO_SIDED|95.0|0.0|40.36||P-values are nominal.|Exact poisson regression|||Event rates were computed by dividing the number of hospitalizations over 4-weeks by the number of person-years. An exact poisson regression was used to compare events by treatment group.||40.36|0|1.00
72422645|NCT03587142|144356356|SUPERIORITY|||||||0.52||||||Nominal P value.|Binomial probability test|2-sided test with probability of success=0||||||0.52
72331650|NCT01942668|144188409|SUPERIORITY||Mean Difference (Final Values)|-7.39|STANDARD_ERROR_OF_MEAN|2.434||0.003|TWO_SIDED|95.0|-12.17|-2.61||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||-2.61|-12.17|0.003
72422646|NCT03502616|144356402|SUPERIORITY||Difference in percentage|27.08|STANDARD_ERROR_OF_MEAN|5.71|<|0.0001|TWO_SIDED|95.0|15.89|38.28|||Cochran-Mantel-Haenszel|||Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via Cochran-Mantel-Haenszel (CMH) approach.||38.28|15.89|<0.0001
72422647|NCT03502616|144356403|SUPERIORITY||Difference in percentage|28.17|STANDARD_ERROR_OF_MEAN|5.06|<|0.0001|TWO_SIDED|95.0|18.26|38.09|||Cochran-Mantel-Haenszel|||Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||38.09|18.26|<0.0001
72422648|NCT03502616|144356410|SUPERIORITY||Difference in percentage|18.28|STANDARD_ERROR_OF_MEAN|4.7||0.0001|TWO_SIDED|95.0|9.06|27.5|||Cochran-Mantel-Haenszel|||Week 2: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||27.50|9.06|0.0001
72422649|NCT03502616|144356410|SUPERIORITY||Difference in percentage|31.35|STANDARD_ERROR_OF_MEAN|5.47|<|0.0001|TWO_SIDED|95.0|20.64|42.06|||Cochran-Mantel-Haenszel|||Week 4: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||42.06|20.64|<0.0001
72422650|NCT03502616|144356410|SUPERIORITY||Difference in percentage|32.24|STANDARD_ERROR_OF_MEAN|5.57|<|0.0001|TWO_SIDED|95.0|21.32|43.17|||Cochran-Mantel-Haenszel|||Week 8: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||43.17|21.32|<0.0001
72422651|NCT03502616|144356410|SUPERIORITY||Difference in percentage|34.61|STANDARD_ERROR_OF_MEAN|5.6|<|0.0001|TWO_SIDED|95.0|23.63|45.58|||Cochran-Mantel-Haenszel|||Week 12: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||45.58|23.63|<0.0001
72422652|NCT03502616|144356410|SUPERIORITY||Difference in percentage|3.65|STANDARD_ERROR_OF_MEAN|5.9||0.536|TWO_SIDED|95.0|-7.92|15.22|||Cochran-Mantel-Haenszel|||Week 24: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||15.22|-7.92|0.5360
72422653|NCT03502616|144356410|SUPERIORITY||Difference in percentage|3.83|STANDARD_ERROR_OF_MEAN|5.63||0.4971|TWO_SIDED|95.0|-7.22|14.87|||Cochran-Mantel-Haenszel|||Week 32: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||14.87|-7.22|0.4971
72422654|NCT03502616|144356410|SUPERIORITY||Difference in percentage|1.58|STANDARD_ERROR_OF_MEAN|5.65||0.7792|TWO_SIDED|95.0|-9.49|12.66|||Cochran-Mantel-Haenszel|||Week 40: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||12.66|-9.49|0.7792
72422655|NCT03502616|144356410|SUPERIORITY||Difference in percentage|5.22|STANDARD_ERROR_OF_MEAN|5.8||0.3685|TWO_SIDED|95.0|-6.15|16.58|||Cochran-Mantel-Haenszel|||Week 48: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||16.58|-6.15|0.3685
72422656|NCT03502616|144356411|SUPERIORITY||Difference in percentage|6.12|STANDARD_ERROR_OF_MEAN|3.19||0.0548|TWO_SIDED|95.0|-0.13|12.37|||Cochran-Mantel-Haenszel|||Week 2: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||12.37|-0.13|0.0548
72331651|NCT01942668|144188409|SUPERIORITY||Mean Difference (Final Values)|-6.69|STANDARD_ERROR_OF_MEAN|2.429||0.006|TWO_SIDED|95.0|-11.46|-1.92||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||-1.92|-11.46|0.006
72331652|NCT01942668|144188410|SUPERIORITY||Mean Difference (Final Values)|-4.21|STANDARD_ERROR_OF_MEAN|2.037||0.039|TWO_SIDED|95.0|-8.21|-0.21||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||-0.21|-8.21|0.039
72331653|NCT01942668|144188410|SUPERIORITY||Mean Difference (Final Values)|-2.39|STANDARD_ERROR_OF_MEAN|1.997||0.232|TWO_SIDED|95.0|-6.31|1.53||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||1.53|-6.31|0.232
72331654|NCT01942668|144188410|SUPERIORITY||Mean Difference (Final Values)|-4.37|STANDARD_ERROR_OF_MEAN|2.012||0.03|TWO_SIDED|95.0|-8.32|-0.42||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||-0.42|-8.32|0.030
72331655|NCT01942668|144188410|SUPERIORITY||Mean Difference (Final Values)|-2.22|STANDARD_ERROR_OF_MEAN|1.973||0.262|TWO_SIDED|95.0|-6.09|1.66||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||1.66|-6.09|0.262
72331656|NCT01942668|144188411|SUPERIORITY||Mean Difference (Final Values)|-5.41|STANDARD_ERROR_OF_MEAN|2.119||0.011|TWO_SIDED|95.0|-9.57|-1.25||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||-1.25|-9.57|0.011
72331657|NCT01942668|144188411|SUPERIORITY||Mean Difference (Final Values)|-5.54|STANDARD_ERROR_OF_MEAN|2.065||0.008|TWO_SIDED|95.0|-9.6|-1.48||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||-1.48|-9.60|0.008
72331658|NCT01942668|144188411|SUPERIORITY||Mean Difference (Final Values)|-5.74|STANDARD_ERROR_OF_MEAN|2.115||0.007|TWO_SIDED|95.0|-9.9|-1.59||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||-1.59|-9.90|0.007
72331659|NCT01942668|144188411|SUPERIORITY||Mean Difference (Final Values)|-5.32|STANDARD_ERROR_OF_MEAN|2.078||0.011|TWO_SIDED|95.0|-9.4|-1.24||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||-1.24|-9.40|0.011
72331660|NCT01942668|144188412|SUPERIORITY||Mean Difference (Final Values)|-4.21|STANDARD_ERROR_OF_MEAN|2.421||0.083|TWO_SIDED|95.0|-8.96|0.55||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||0.55|-8.96|0.083
72331661|NCT01942668|144188412|SUPERIORITY||Mean Difference (Final Values)|-7.36|STANDARD_ERROR_OF_MEAN|2.317||0.002|TWO_SIDED|95.0|-11.91|-2.81||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||-2.81|-11.91|0.002
72331662|NCT01942668|144188412|SUPERIORITY||Mean Difference (Final Values)|-7.92|STANDARD_ERROR_OF_MEAN|2.384|<|0.001|TWO_SIDED|95.0|-12.6|-3.23||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||-3.23|-12.60|<0.001
72331663|NCT01942668|144188412|SUPERIORITY||Mean Difference (Final Values)|-6.78|STANDARD_ERROR_OF_MEAN|2.381||0.005|TWO_SIDED|95.0|-11.46|-2.1||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||-2.10|-11.46|0.005
72331664|NCT01942668|144188413|SUPERIORITY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.06||0.938|TWO_SIDED|95.0|-0.12|0.11||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||0.11|-0.12|0.938
72331665|NCT01942668|144188413|SUPERIORITY||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.059||0.779|TWO_SIDED|95.0|-0.1|0.13||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||0.13|-0.10|0.779
72422657|NCT03502616|144356411|SUPERIORITY||Difference in percentage|23.43|STANDARD_ERROR_OF_MEAN|4.15|<|0.0001|TWO_SIDED|95.0|15.3|31.56|||Cochran-Mantel-Haenszel|||Week 4: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||31.56|15.30|<0.0001
72422658|NCT03502616|144356411|SUPERIORITY||Difference in percentage|28.56|STANDARD_ERROR_OF_MEAN|4.54|<|0.0001|TWO_SIDED|95.0|19.66|37.47|||Cochran-Mantel-Haenszel|||Week 8: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||37.47|19.66|<0.0001
72331666|NCT01942668|144188413|SUPERIORITY||Mean Difference (Final Values)|-0.03|STANDARD_ERROR_OF_MEAN|0.059||0.646|TWO_SIDED|95.0|-0.14|0.09||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||0.09|-0.14|0.646
72331667|NCT01942668|144188413|SUPERIORITY||Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.058||0.421|TWO_SIDED|95.0|-0.07|0.16||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||0.16|-0.07|0.421
72331668|NCT01942668|144188414|SUPERIORITY||Mean Difference (Final Values)|0.11|STANDARD_ERROR_OF_MEAN|0.063||0.075|TWO_SIDED|95.0|-0.01|0.24||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||0.24|-0.01|0.075
72422659|NCT03502616|144356411|SUPERIORITY||Difference in percentage|31.18|STANDARD_ERROR_OF_MEAN|5.02|<|0.0001|TWO_SIDED|95.0|21.34|41.02|||Cochran-Mantel-Haenszel|||Week 12: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||41.02|21.34|<0.0001
72331669|NCT01942668|144188414|SUPERIORITY||Mean Difference (Final Values)|0.11|STANDARD_ERROR_OF_MEAN|0.062||0.074|TWO_SIDED|95.0|-0.01|0.23||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||0.23|-0.01|0.074
72331670|NCT01942668|144188414|SUPERIORITY||Mean Difference (Final Values)|0.06|STANDARD_ERROR_OF_MEAN|0.063||0.37|TWO_SIDED|95.0|-0.07|0.18||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||0.18|-0.07|0.370
72331671|NCT01942668|144188414|SUPERIORITY||Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.062||0.851|TWO_SIDED|95.0|-0.11|0.13||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||0.13|-0.11|0.851
72331672|NCT01942668|144188415|SUPERIORITY||Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.067||0.452|TWO_SIDED|95.0|-0.18|0.08||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||0.08|-0.18|0.452
72331673|NCT01942668|144188415|SUPERIORITY||Mean Difference (Final Values)|0.07|STANDARD_ERROR_OF_MEAN|0.064||0.244|TWO_SIDED|95.0|-0.05|0.2||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||0.20|-0.05|0.244
72331674|NCT01942668|144188415|SUPERIORITY||Mean Difference (Final Values)|-0.06|STANDARD_ERROR_OF_MEAN|0.065||0.354|TWO_SIDED|95.0|-0.19|0.07||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||0.07|-0.19|0.354
72331675|NCT01942668|144188415|SUPERIORITY||Mean Difference (Final Values)|-0.04|STANDARD_ERROR_OF_MEAN|0.065||0.527|TWO_SIDED|95.0|-0.17|0.09||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||0.09|-0.17|0.527
72331676|NCT01942668|144188416|SUPERIORITY||Mean Difference (Final Values)|-1.92|STANDARD_ERROR_OF_MEAN|0.19|<|0.001|TWO_SIDED|95.0|-2.29|-1.55||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||-1.55|-2.29|<0.001
72331677|NCT01942668|144188416|SUPERIORITY||Mean Difference (Final Values)|-1.44|STANDARD_ERROR_OF_MEAN|0.189|<|0.001|TWO_SIDED|95.0|-1.81|-1.07||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||-1.07|-1.81|<0.001
72331678|NCT01942668|144188416|SUPERIORITY||Mean Difference (Final Values)|-1.44|STANDARD_ERROR_OF_MEAN|0.189|<|0.001|TWO_SIDED|95.0|-1.81|-1.07||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||-1.07|-1.81|<0.001
72422660|NCT03502616|144356411|SUPERIORITY||Difference in percentage|6.29|STANDARD_ERROR_OF_MEAN|5.98||0.2926|TWO_SIDED|95.0|-5.43|18.01|||Cochran-Mantel-Haenszel|||Week 24: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||18.01|-5.43|0.2926
72422661|NCT03502616|144356411|SUPERIORITY||Difference in percentage|6.37|STANDARD_ERROR_OF_MEAN|5.97||0.2856|TWO_SIDED|95.0|-5.32|18.06|||Cochran-Mantel-Haenszel|||Week 32: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||18.06|-5.32|0.2856
72422662|NCT03502616|144356411|SUPERIORITY||Difference in percentage|7.83|STANDARD_ERROR_OF_MEAN|5.97||0.1894|TWO_SIDED|95.0|-3.87|19.54|||Cochran-Mantel-Haenszel|||Week 40: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach||19.54|-3.87|0.1894
72422663|NCT03502616|144356411|SUPERIORITY||Difference in percentage|5.59|STANDARD_ERROR_OF_MEAN|6.04||0.3544|TWO_SIDED|95.0|-6.24|17.43|||Cochran-Mantel-Haenszel|||Week 48: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach||17.43|-6.24|0.3544
72422664|NCT03502616|144356412|SUPERIORITY||LS mean difference|-0.71|STANDARD_ERROR_OF_MEAN|0.072|<|0.0001|TWO_SIDED|95.0|-0.85|-0.57|||Mixed Models Analysis|||Week 2: Analysis performed using Mixed model for repeated measures (MMRM) which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-0.57|-0.85|<0.0001
72422665|NCT03502616|144356412|SUPERIORITY||LS mean difference|-0.9|STANDARD_ERROR_OF_MEAN|0.083|<|0.0001|TWO_SIDED|95.0|-1.07|-0.74|||Mixed Models Analysis|||Week 4: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-0.74|-1.07|<0.0001
72331679|NCT01942668|144188416|SUPERIORITY||Mean Difference (Final Values)|-1.25|STANDARD_ERROR_OF_MEAN|0.188|<|0.001|TWO_SIDED|95.0|-1.62|-0.88||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||-0.88|-1.62|<0.001
72331680|NCT01942668|144188417|SUPERIORITY||Mean Difference (Final Values)|-1.73|STANDARD_ERROR_OF_MEAN|0.199|<|0.001|TWO_SIDED|95.0|-2.12|-1.34||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||-1.34|-2.12|<0.001
72422666|NCT03502616|144356412|SUPERIORITY||LS mean difference|-1.06|STANDARD_ERROR_OF_MEAN|0.095|<|0.0001|TWO_SIDED|95.0|-1.25|-0.87|||Mixed Models Analysis|||Week 8: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-0.87|-1.25|<0.0001
72422667|NCT03502616|144356412|SUPERIORITY||LS mean difference|-1.09|STANDARD_ERROR_OF_MEAN|0.096|<|0.0001|TWO_SIDED|95.0|-1.28|-0.9|||Mixed Models Analysis|||Week 12: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-0.90|-1.28|<0.0001
72422668|NCT03502616|144356412|SUPERIORITY||LS mean difference|-0.98|STANDARD_ERROR_OF_MEAN|0.093|<|0.0001|TWO_SIDED|95.0|-1.16|-0.79|||Mixed Models Analysis|||Week 16: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-0.79|-1.16|<0.0001
72422669|NCT03502616|144356412|SUPERIORITY||LS mean difference|-0.19|STANDARD_ERROR_OF_MEAN|0.103||0.0623|TWO_SIDED|95.0|-0.4|0.01|||Mixed Models Analysis|||Week 24: Analysis performed using Mixed model for repeated measures (MMRM) which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.01|-0.40|0.0623
72422670|NCT03502616|144356412|SUPERIORITY||LS mean difference|-0.18|STANDARD_ERROR_OF_MEAN|0.106||0.0836|TWO_SIDED|95.0|-0.39|0.02|||Mixed Models Analysis|||Week 32: Analysis performed using Mixed model for repeated measures (MMRM) which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.02|-0.39|0.0836
72422671|NCT03502616|144356412|SUPERIORITY||LS mean difference|-0.25|STANDARD_ERROR_OF_MEAN|0.108||0.0205|TWO_SIDED|95.0|-0.47|-0.04|||Mixed Models Analysis|||Week 40: Analysis performed using Mixed model for repeated measures (MMRM) which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-0.04|-0.47|0.0205
72422672|NCT03502616|144356412|SUPERIORITY||LS mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.108||0.0614|TWO_SIDED|95.0|-0.42|0.01|||Mixed Models Analysis|||Week 48: Analysis performed using Mixed model for repeated measures (MMRM) which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.01|-0.42|0.0614
72422673|NCT03502616|144356413|SUPERIORITY||LS mean difference|-0.93|STANDARD_ERROR_OF_MEAN|0.113|<|0.0001|TWO_SIDED|95.0|-1.15|-0.7|||Mixed Models Analysis|||Week 2: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-0.70|-1.15|<0.0001
72422674|NCT03502616|144356413|SUPERIORITY||LS mean difference|-0.92|STANDARD_ERROR_OF_MEAN|0.121|<|0.0001|TWO_SIDED|95.0|-1.16|-0.68|||Mixed Models Analysis|||Week 4: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-0.68|-1.16|<0.0001
72331681|NCT01942668|144188417|SUPERIORITY||Mean Difference (Final Values)|-1.29|STANDARD_ERROR_OF_MEAN|0.197|<|0.001|TWO_SIDED|95.0|-1.68|-0.91||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||-0.91|-1.68|<0.001
72331682|NCT01942668|144188417|SUPERIORITY||Mean Difference (Final Values)|-1.2|STANDARD_ERROR_OF_MEAN|0.197|<|0.001|TWO_SIDED|95.0|-1.58|-0.81||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||-0.81|-1.58|<0.001
72331683|NCT01942668|144188417|SUPERIORITY||Mean Difference (Final Values)|-0.96|STANDARD_ERROR_OF_MEAN|0.198|<|0.001|TWO_SIDED|95.0|-1.34|-0.57||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||-0.57|-1.34|<0.001
72331684|NCT01942668|144188418|SUPERIORITY||Mean Difference (Final Values)|-1.65|STANDARD_ERROR_OF_MEAN|0.207|<|0.001|TWO_SIDED|95.0|-2.06|-1.25||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||-1.25|-2.06|<0.001
72331685|NCT01942668|144188418|SUPERIORITY||Mean Difference (Final Values)|-1.47|STANDARD_ERROR_OF_MEAN|0.204|<|0.001|TWO_SIDED|95.0|-1.87|-1.07||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||-1.07|-1.87|<0.001
72422675|NCT03502616|144356413|SUPERIORITY||LS mean difference|-1.02|STANDARD_ERROR_OF_MEAN|0.196|<|0.0001|TWO_SIDED|95.0|-1.4|-0.63|||Mixed Models Analysis|||Week 8: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-0.63|-1.40|<0.0001
72422676|NCT03502616|144356413|SUPERIORITY||LS mean difference|-0.96|STANDARD_ERROR_OF_MEAN|0.115|<|0.0001|TWO_SIDED|95.0|-1.19|-0.74|||Mixed Models Analysis|||Week 12: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-0.74|-1.19|<0.0001
72331686|NCT01942668|144188418|SUPERIORITY||Mean Difference (Final Values)|-1.3|STANDARD_ERROR_OF_MEAN|0.205|<|0.001|TWO_SIDED|95.0|-1.7|-0.9||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||-0.90|-1.70|<0.001
72331687|NCT01942668|144188418|SUPERIORITY||Mean Difference (Final Values)|-1.08|STANDARD_ERROR_OF_MEAN|0.207|<|0.001|TWO_SIDED|95.0|-1.48|-0.67||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||-0.67|-1.48|<0.001
72331688|NCT01942668|144188419|SUPERIORITY||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.131||0.126|TWO_SIDED|95.0|-0.46|0.06||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||0.06|-0.46|0.126
72331689|NCT01942668|144188419|SUPERIORITY||Mean Difference (Final Values)|-0.17|STANDARD_ERROR_OF_MEAN|0.13||0.2|TWO_SIDED|95.0|-0.42|0.09||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||0.09|-0.42|0.200
72331690|NCT01942668|144188419|SUPERIORITY||Mean Difference (Final Values)|-0.16|STANDARD_ERROR_OF_MEAN|0.13||0.222|TWO_SIDED|95.0|-0.41|0.1||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||0.10|-0.41|0.222
72331691|NCT01942668|144188419|SUPERIORITY||Mean Difference (Final Values)|-0.12|STANDARD_ERROR_OF_MEAN|0.13||0.358|TWO_SIDED|95.0|-0.37|0.14||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||0.14|-0.37|0.358
72331692|NCT01942668|144188420|SUPERIORITY||Mean Difference (Final Values)|-0.31|STANDARD_ERROR_OF_MEAN|0.138||0.023|TWO_SIDED|95.0|-0.59|-0.04||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||-0.04|-0.59|0.023
72331693|NCT01942668|144188420|SUPERIORITY||Mean Difference (Final Values)|-0.28|STANDARD_ERROR_OF_MEAN|0.138||0.045|TWO_SIDED|95.0|-0.55|-0.01||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||-0.01|-0.55|0.045
72331694|NCT01942668|144188420|SUPERIORITY||Mean Difference (Final Values)|-0.12|STANDARD_ERROR_OF_MEAN|0.137||0.384|TWO_SIDED|95.0|-0.39|0.15||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||0.15|-0.39|0.384
72331695|NCT01942668|144188420|SUPERIORITY||Mean Difference (Final Values)|-0.11|STANDARD_ERROR_OF_MEAN|0.138||0.424|TWO_SIDED|95.0|-0.38|0.16||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||0.16|-0.38|0.424
72331696|NCT01942668|144188421|SUPERIORITY||Mean Difference (Final Values)|-0.22|STANDARD_ERROR_OF_MEAN|0.152||0.153|TWO_SIDED|95.0|-0.52|0.08||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||0.08|-0.52|0.153
72331697|NCT01942668|144188421|SUPERIORITY||Mean Difference (Final Values)|-0.29|STANDARD_ERROR_OF_MEAN|0.151||0.058|TWO_SIDED|95.0|-0.58|0.01||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||0.01|-0.58|0.058
72331698|NCT01942668|144188421|SUPERIORITY||Mean Difference (Final Values)|-0.09|STANDARD_ERROR_OF_MEAN|0.151||0.55|TWO_SIDED|95.0|-0.39|0.21||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||0.21|-0.39|0.550
72331699|NCT01942668|144188421|SUPERIORITY||Mean Difference (Final Values)|-0.03|STANDARD_ERROR_OF_MEAN|0.153||0.854|TWO_SIDED|95.0|-0.33|0.27||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||0.27|-0.33|0.854
72331700|NCT01942668|144188422|SUPERIORITY||Mean Difference (Final Values)|-0.16|STANDARD_ERROR_OF_MEAN|0.116||0.181|TWO_SIDED|95.0|-0.38|0.07||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||0.07|-0.38|0.181
72331701|NCT01942668|144188422|SUPERIORITY||Mean Difference (Final Values)|-0.19|STANDARD_ERROR_OF_MEAN|0.116||0.108|TWO_SIDED|95.0|-0.41|0.04||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||0.04|-0.41|0.108
72331702|NCT01942668|144188422|SUPERIORITY||Mean Difference (Final Values)|-0.28|STANDARD_ERROR_OF_MEAN|0.115||0.014|TWO_SIDED|95.0|-0.51|-0.06||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||-0.06|-0.51|0.014
72331703|NCT01942668|144188422|SUPERIORITY||Mean Difference (Final Values)|-0.11|STANDARD_ERROR_OF_MEAN|0.115||0.323|TWO_SIDED|95.0|-0.34|0.11||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||0.11|-0.34|0.323
72331704|NCT01942668|144188423|SUPERIORITY||Mean Difference (Final Values)|-0.24|STANDARD_ERROR_OF_MEAN|0.124||0.056|TWO_SIDED|95.0|-0.48|0.01||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||0.01|-0.48|0.056
72331705|NCT01942668|144188423|SUPERIORITY||Mean Difference (Final Values)|-0.13|STANDARD_ERROR_OF_MEAN|0.124||0.279|TWO_SIDED|95.0|-0.38|0.11||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||0.11|-0.38|0.279
72331706|NCT01942668|144188423|SUPERIORITY||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.123||0.435|TWO_SIDED|95.0|-0.34|0.15||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||0.15|-0.34|0.435
72331707|NCT01942668|144188423|SUPERIORITY||Mean Difference (Final Values)|-0.06|STANDARD_ERROR_OF_MEAN|0.124||0.607|TWO_SIDED|95.0|-0.31|0.18||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||0.18|-0.31|0.607
72331708|NCT01942668|144188424|SUPERIORITY||Mean Difference (Final Values)|-0.26|STANDARD_ERROR_OF_MEAN|0.138||0.06|TWO_SIDED|95.0|-0.53|0.01||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||0.01|-0.53|0.060
72331709|NCT01942668|144188424|SUPERIORITY||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.137||0.026|TWO_SIDED|95.0|-0.57|-0.04||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||-0.04|-0.57|0.026
72331710|NCT01942668|144188424|SUPERIORITY||Mean Difference (Final Values)|-0.23|STANDARD_ERROR_OF_MEAN|0.136||0.097|TWO_SIDED|95.0|-0.49|0.04||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||0.04|-0.49|0.097
72331711|NCT01942668|144188424|SUPERIORITY||Mean Difference (Final Values)|-0.17|STANDARD_ERROR_OF_MEAN|0.138||0.23|TWO_SIDED|95.0|-0.44|0.1||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||0.10|-0.44|0.230
72331712|NCT01942668|144188425|SUPERIORITY||Mean Difference (Final Values)|-0.27|STANDARD_ERROR_OF_MEAN|0.17||0.107|TWO_SIDED|95.0|-0.61|0.06||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||0.06|-0.61|0.107
72331713|NCT01942668|144188425|SUPERIORITY||Mean Difference (Final Values)|-0.17|STANDARD_ERROR_OF_MEAN|0.169||0.302|TWO_SIDED|95.0|-0.51|0.16||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||0.16|-0.51|0.302
72331714|NCT01942668|144188425|SUPERIORITY||Mean Difference (Final Values)|-0.27|STANDARD_ERROR_OF_MEAN|0.169||0.106|TWO_SIDED|95.0|-0.6|0.06||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||0.06|-0.60|0.106
72331715|NCT01942668|144188425|SUPERIORITY||Mean Difference (Final Values)|-0.24|STANDARD_ERROR_OF_MEAN|0.169||0.156|TWO_SIDED|95.0|-0.57|0.09||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||0.09|-0.57|0.156
72331716|NCT01942668|144188426|SUPERIORITY||Mean Difference (Final Values)|-0.31|STANDARD_ERROR_OF_MEAN|0.177||0.081|TWO_SIDED|95.0|-0.65|0.04||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||0.04|-0.65|0.081
72331717|NCT01942668|144188426|SUPERIORITY||Mean Difference (Final Values)|-0.22|STANDARD_ERROR_OF_MEAN|0.175||0.212|TWO_SIDED|95.0|-0.56|0.12||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||0.12|-0.56|0.212
72331718|NCT01942668|144188426|SUPERIORITY||Mean Difference (Final Values)|-0.17|STANDARD_ERROR_OF_MEAN|0.175||0.345|TWO_SIDED|95.0|-0.51|0.18||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||0.18|-0.51|0.345
72331719|NCT01942668|144188426|SUPERIORITY||Mean Difference (Final Values)|-0.04|STANDARD_ERROR_OF_MEAN|0.176||0.829|TWO_SIDED|95.0|-0.38|0.31||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||0.31|-0.38|0.829
72331720|NCT01942668|144188427|SUPERIORITY||Mean Difference (Final Values)|-0.44|STANDARD_ERROR_OF_MEAN|0.201||0.029|TWO_SIDED|95.0|-0.84|-0.05||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||-0.05|-0.84|0.029
72331721|NCT01942668|144188427|SUPERIORITY||Mean Difference (Final Values)|-0.45|STANDARD_ERROR_OF_MEAN|0.199||0.026|TWO_SIDED|95.0|-0.84|-0.05||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||-0.05|-0.84|0.026
72331722|NCT01942668|144188427|SUPERIORITY||Mean Difference (Final Values)|-0.33|STANDARD_ERROR_OF_MEAN|0.199||0.093|TWO_SIDED|95.0|-0.72|0.06||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||0.06|-0.72|0.093
72331723|NCT01942668|144188427|SUPERIORITY||Mean Difference (Final Values)|-0.25|STANDARD_ERROR_OF_MEAN|0.202||0.223|TWO_SIDED|95.0|-0.64|0.15||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||0.15|-0.64|0.223
72331724|NCT01942668|144188428|SUPERIORITY||Mean Difference (Final Values)|-0.62|STANDARD_ERROR_OF_MEAN|0.12|<|0.001|TWO_SIDED|95.0|-0.85|-0.4||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||-0.40|-0.85|<0.001
72331725|NCT01942668|144188428|SUPERIORITY||Mean Difference (Final Values)|-0.49|STANDARD_ERROR_OF_MEAN|0.11|<|0.001|TWO_SIDED|95.0|-0.71|-0.26||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||-0.26|-0.71|<0.001
72331726|NCT01942668|144188428|SUPERIORITY||Mean Difference (Final Values)|-0.52|STANDARD_ERROR_OF_MEAN|0.11|<|0.001|TWO_SIDED|95.0|-0.75|-0.3||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||-0.30|-0.75|<0.001
72331727|NCT01942668|144188428|SUPERIORITY||Mean Difference (Final Values)|-0.42|STANDARD_ERROR_OF_MEAN|0.11|<|0.001|TWO_SIDED|95.0|-0.64|-0.2||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||-0.20|-0.64|<0.001
72331728|NCT01942668|144188429|SUPERIORITY||Mean Difference (Final Values)|-0.61|STANDARD_ERROR_OF_MEAN|0.12|<|0.001|TWO_SIDED|95.0|-0.85|-0.38||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||-0.38|-0.85|<0.001
72331729|NCT01942668|144188429|SUPERIORITY||Mean Difference (Final Values)|-0.45|STANDARD_ERROR_OF_MEAN|0.12|<|0.001|TWO_SIDED|95.0|-0.69|-0.22||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||-0.22|-0.69|<0.001
72331730|NCT01942668|144188429|SUPERIORITY||Mean Difference (Final Values)|-0.36|STANDARD_ERROR_OF_MEAN|0.12||0.003|TWO_SIDED|95.0|-0.59|-0.12||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||-0.12|-0.59|0.003
72331731|NCT01942668|144188429|SUPERIORITY||Mean Difference (Final Values)|-0.26|STANDARD_ERROR_OF_MEAN|0.12||0.03|TWO_SIDED|95.0|-0.5|-0.03||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||-0.03|-0.50|0.030
72422677|NCT03502616|144356413|SUPERIORITY||LS mean difference|-0.96|STANDARD_ERROR_OF_MEAN|0.122|<|0.0001|TWO_SIDED|95.0|-1.2|-0.72|||Mixed Models Analysis|||Week 16: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-0.72|-1.20|<0.0001
72331732|NCT01942668|144188430|SUPERIORITY||Mean Difference (Final Values)|-0.62|STANDARD_ERROR_OF_MEAN|0.13|<|0.001|TWO_SIDED|95.0|-0.89|-0.36||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||-0.36|-0.89|<0.001
72331733|NCT01942668|144188430|SUPERIORITY||Mean Difference (Final Values)|-0.62|STANDARD_ERROR_OF_MEAN|0.13|<|0.001|TWO_SIDED|95.0|-0.88|-0.36||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||-0.36|-0.88|<0.001
72331734|NCT01942668|144188430|SUPERIORITY||Mean Difference (Final Values)|-0.47|STANDARD_ERROR_OF_MEAN|0.13|<|0.001|TWO_SIDED|95.0|-0.73|-0.21||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||-0.21|-0.73|<0.001
72331735|NCT01942668|144188430|SUPERIORITY||Mean Difference (Final Values)|-0.37|STANDARD_ERROR_OF_MEAN|0.13||0.006|TWO_SIDED|95.0|-0.63|-0.1||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||-0.10|-0.63|0.006
72422678|NCT03502616|144356413|SUPERIORITY||LS mean difference|-0.05|STANDARD_ERROR_OF_MEAN|0.073||0.4731|TWO_SIDED|95.0|-0.2|0.09|||Mixed Models Analysis|||Week 24: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.09|-0.20|0.4731
72331736|NCT01942668|144188431|SUPERIORITY||Mean Difference (Final Values)|-4.88|STANDARD_ERROR_OF_MEAN|1.629||0.003|TWO_SIDED|95.0|-8.08|-1.69||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||-1.69|-8.08|0.003
72331737|NCT01942668|144188431|SUPERIORITY||Mean Difference (Final Values)|-3.61|STANDARD_ERROR_OF_MEAN|1.626||0.027|TWO_SIDED|95.0|-6.8|-0.42||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||-0.42|-6.80|0.027
72331738|NCT01942668|144188431|SUPERIORITY||Mean Difference (Final Values)|-3.44|STANDARD_ERROR_OF_MEAN|1.618||0.034|TWO_SIDED|95.0|-6.61|-0.26||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||-0.26|-6.61|0.034
72331739|NCT01942668|144188431|SUPERIORITY||Mean Difference (Final Values)|-2.53|STANDARD_ERROR_OF_MEAN|1.621||0.119|TWO_SIDED|95.0|-5.71|0.65||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||0.65|-5.71|0.119
72331740|NCT01942668|144188432|SUPERIORITY||Mean Difference (Final Values)|-5.39|STANDARD_ERROR_OF_MEAN|1.7||0.002|TWO_SIDED|95.0|-8.73|-2.05||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||-2.05|-8.73|0.002
72331741|NCT01942668|144188432|SUPERIORITY||Mean Difference (Final Values)|-5.39|STANDARD_ERROR_OF_MEAN|1.696||0.002|TWO_SIDED|95.0|-8.72|-2.06||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||-2.06|-8.72|0.002
72422679|NCT03502616|144356413|SUPERIORITY||LS mean difference|-0.08|STANDARD_ERROR_OF_MEAN|0.094||0.4055|TWO_SIDED|95.0|-0.26|0.11|||Mixed Models Analysis|||Week 32: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.11|-0.26|0.4055
72331742|NCT01942668|144188432|SUPERIORITY||Mean Difference (Final Values)|-4.88|STANDARD_ERROR_OF_MEAN|1.685||0.004|TWO_SIDED|95.0|-8.19|-1.58||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||-1.58|-8.19|0.004
72331743|NCT01942668|144188432|SUPERIORITY||Mean Difference (Final Values)|-4.42|STANDARD_ERROR_OF_MEAN|1.698||0.009|TWO_SIDED|95.0|-7.75|-1.09||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||-1.09|-7.75|0.009
72331744|NCT01942668|144188433|SUPERIORITY||Mean Difference (Final Values)|-6.54|STANDARD_ERROR_OF_MEAN|1.855|<|0.001|TWO_SIDED|95.0|-10.18|-2.9||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||-2.90|-10.18|<0.001
72331745|NCT01942668|144188433|SUPERIORITY||Mean Difference (Final Values)|-7.61|STANDARD_ERROR_OF_MEAN|1.843|<|0.001|TWO_SIDED|95.0|-11.23|-4.0||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||-4.00|-11.23|<0.001
72331746|NCT01942668|144188433|SUPERIORITY||Mean Difference (Final Values)|-7.44|STANDARD_ERROR_OF_MEAN|1.835|<|0.001|TWO_SIDED|95.0|-11.04|-3.84||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||-3.84|-11.04|<0.001
72331747|NCT01942668|144188433|SUPERIORITY||Mean Difference (Final Values)|-6.76|STANDARD_ERROR_OF_MEAN|1.863|<|0.001|TWO_SIDED|95.0|-10.41|-3.1||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||-3.10|-10.41|<0.001
72331748|NCT01942668|144188434|SUPERIORITY||Mean Difference (Final Values)|-7.34|STANDARD_ERROR_OF_MEAN|2.146|<|0.001|TWO_SIDED|95.0|-11.55|-3.13||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||-3.13|-11.55|<0.001
72331749|NCT01942668|144188434|SUPERIORITY||Mean Difference (Final Values)|-5.6|STANDARD_ERROR_OF_MEAN|2.139||0.009|TWO_SIDED|95.0|-9.8|-1.4||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||-1.40|-9.80|0.009
72331750|NCT01942668|144188434|SUPERIORITY||Mean Difference (Final Values)|-5.13|STANDARD_ERROR_OF_MEAN|2.132||0.016|TWO_SIDED|95.0|-9.31|-0.95||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||-0.95|-9.31|0.016
72331751|NCT01942668|144188434|SUPERIORITY||Mean Difference (Final Values)|-3.04|STANDARD_ERROR_OF_MEAN|2.13||0.154|TWO_SIDED|95.0|-7.22|1.14||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||1.14|-7.22|0.154
72331752|NCT01942668|144188435|SUPERIORITY||Mean Difference (Final Values)|-8.38|STANDARD_ERROR_OF_MEAN|2.213|<|0.001|TWO_SIDED|95.0|-12.72|-4.04||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||-4.04|-12.72|<0.001
72331753|NCT01942668|144188435|SUPERIORITY||Mean Difference (Final Values)|-7.52|STANDARD_ERROR_OF_MEAN|2.201|<|0.001|TWO_SIDED|95.0|-11.83|-3.2||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||-3.20|-11.83|<0.001
72331754|NCT01942668|144188435|SUPERIORITY||Mean Difference (Final Values)|-7.32|STANDARD_ERROR_OF_MEAN|2.193|<|0.001|TWO_SIDED|95.0|-11.63|-3.02||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||-3.02|-11.63|<0.001
72331755|NCT01942668|144188435|SUPERIORITY||Mean Difference (Final Values)|-5.6|STANDARD_ERROR_OF_MEAN|2.207||0.011|TWO_SIDED|95.0|-9.93|-1.27||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||-1.27|-9.93|0.011
72331756|NCT01942668|144188436|SUPERIORITY||Mean Difference (Final Values)|-8.97|STANDARD_ERROR_OF_MEAN|2.439|<|0.001|TWO_SIDED|95.0|-13.76|-4.19||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||-4.19|-13.76|<0.001
72331757|NCT01942668|144188436|SUPERIORITY||Mean Difference (Final Values)|-9.6|STANDARD_ERROR_OF_MEAN|2.42|<|0.001|TWO_SIDED|95.0|-14.34|-4.85||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||-4.85|-14.34|<0.001
72331758|NCT01942668|144188436|SUPERIORITY||Mean Difference (Final Values)|-9.3|STANDARD_ERROR_OF_MEAN|2.412|<|0.001|TWO_SIDED|95.0|-14.03|-4.56||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||-4.56|-14.03|<0.001
72331759|NCT01942668|144188436|SUPERIORITY||Mean Difference (Final Values)|-7.72|STANDARD_ERROR_OF_MEAN|2.442||0.002|TWO_SIDED|95.0|-12.51|-2.93||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||-2.93|-12.51|0.002
72331760|NCT01942668|144188437|SUPERIORITY||Mean Difference (Final Values)|2.02|STANDARD_ERROR_OF_MEAN|2.576||0.434|TWO_SIDED|95.0|-3.03|7.07||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||7.07|-3.03|0.434
72331761|NCT01942668|144188437|SUPERIORITY||Mean Difference (Final Values)|1.97|STANDARD_ERROR_OF_MEAN|2.564||0.442|TWO_SIDED|95.0|-3.06|7.0||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||7.00|-3.06|0.442
72331762|NCT01942668|144188437|SUPERIORITY||Mean Difference (Final Values)|1.5|STANDARD_ERROR_OF_MEAN|2.558||0.558|TWO_SIDED|95.0|-3.52|6.51||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||6.51|-3.52|0.558
72422680|NCT03502616|144356413|SUPERIORITY||LS mean difference|-0.12|STANDARD_ERROR_OF_MEAN|0.111||0.2648|TWO_SIDED|95.0|-0.34|0.09|||Mixed Models Analysis|||Week 40: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.09|-0.34|0.2648
72422681|NCT03502616|144356413|SUPERIORITY||LS mean difference|-0.06|STANDARD_ERROR_OF_MEAN|0.099||0.5558|TWO_SIDED|95.0|-0.25|0.14|||Mixed Models Analysis|||Week 48: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.14|-0.25|0.5558
72422682|NCT03502616|144356414|SUPERIORITY||LS mean difference|-2.02|STANDARD_ERROR_OF_MEAN|0.513||0.0001|TWO_SIDED|95.0|-3.03|-1.01|||ANCOVA|||Week 16: Analysis performed using Analysis of covariance (ANCOVA) model which included fixed effects of treatment group, stratification factor derived from clinical database, and baseline value.||-1.01|-3.03|0.0001
72331763|NCT01942668|144188437|SUPERIORITY||Mean Difference (Final Values)|1.59|STANDARD_ERROR_OF_MEAN|2.555||0.534|TWO_SIDED|95.0|-3.42|6.6||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||6.60|-3.42|0.534
72331764|NCT01942668|144188438|SUPERIORITY||Mean Difference (Final Values)|0.25|STANDARD_ERROR_OF_MEAN|2.719||0.927|TWO_SIDED|95.0|-5.08|5.58||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||5.58|-5.08|0.927
72331765|NCT01942668|144188438|SUPERIORITY||Mean Difference (Final Values)|-1.65|STANDARD_ERROR_OF_MEAN|2.699||0.541|TWO_SIDED|95.0|-6.95|3.64||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||3.64|-6.95|0.541
72331766|NCT01942668|144188438|SUPERIORITY||Mean Difference (Final Values)|-3.68|STANDARD_ERROR_OF_MEAN|2.691||0.171|TWO_SIDED|95.0|-8.96|1.6||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||1.60|-8.96|0.171
72331767|NCT01942668|144188438|SUPERIORITY||Mean Difference (Final Values)|-1.17|STANDARD_ERROR_OF_MEAN|2.708||0.667|TWO_SIDED|95.0|-6.48|4.15||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||4.15|-6.48|0.667
72422683|NCT03502616|144356414|SUPERIORITY||LS mean difference|-1.26|STANDARD_ERROR_OF_MEAN|0.567||0.027|TWO_SIDED|95.0|-2.38|-0.14|||Mixed Models Analysis|||Week 48: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-0.14|-2.38|0.0270
72422684|NCT03502616|144356415|SUPERIORITY||LS mean difference|2.22|STANDARD_ERROR_OF_MEAN|0.841||0.0088|TWO_SIDED|95.0|0.56|3.88|||ANCOVA|||Week 16, Physical Functioning: Analysis performed using ANCOVA model which included fixed effects of treatment group, stratification factor derived from clinical database, and baseline value.||3.88|0.56|0.0088
72422685|NCT03502616|144356415|SUPERIORITY||LS mean difference|3.0|STANDARD_ERROR_OF_MEAN|0.939||0.0016|TWO_SIDED|95.0|1.15|4.85|||ANCOVA|||Week 16, Role-Physical: Analysis performed using ANCOVA model which included fixed effects of treatment group, stratification factor derived from clinical database, and baseline value.||4.85|1.15|0.0016
72331768|NCT01942668|144188439|SUPERIORITY||Mean Difference (Final Values)|1.25|STANDARD_ERROR_OF_MEAN|2.863||0.662|TWO_SIDED|95.0|-4.36|6.87||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||6.87|-4.36|0.662
72331769|NCT01942668|144188439|SUPERIORITY||Mean Difference (Final Values)|-1.35|STANDARD_ERROR_OF_MEAN|2.834||0.635|TWO_SIDED|95.0|-6.91|4.21||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||4.21|-6.91|0.635
72331770|NCT01942668|144188439|SUPERIORITY||Mean Difference (Final Values)|-0.44|STANDARD_ERROR_OF_MEAN|2.827||0.877|TWO_SIDED|95.0|-5.98|5.11||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||5.11|-5.98|0.877
72331771|NCT01942668|144188439|SUPERIORITY||Mean Difference (Final Values)|-0.39|STANDARD_ERROR_OF_MEAN|2.867||0.893|TWO_SIDED|95.0|-6.01|5.24||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||5.24|-6.01|0.893
72331772|NCT01942668|144188440|SUPERIORITY||Mean Difference (Final Values)|-0.44|STANDARD_ERROR_OF_MEAN|2.058||0.83|TWO_SIDED|95.0|-4.48|3.59||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||3.59|-4.48|0.830
72331773|NCT01942668|144188440|SUPERIORITY||Mean Difference (Final Values)|-0.64|STANDARD_ERROR_OF_MEAN|2.05||0.755|TWO_SIDED|95.0|-4.66|3.38||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||3.38|-4.66|0.755
72331774|NCT01942668|144188440|SUPERIORITY||Mean Difference (Final Values)|0.51|STANDARD_ERROR_OF_MEAN|2.046||0.802|TWO_SIDED|95.0|-3.5|4.53||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||4.53|-3.50|0.802
72331775|NCT01942668|144188440|SUPERIORITY||Mean Difference (Final Values)|-0.46|STANDARD_ERROR_OF_MEAN|2.043||0.823|TWO_SIDED|95.0|-4.46|3.55||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||3.55|-4.46|0.823
72422686|NCT03502616|144356415|SUPERIORITY||LS mean difference|4.46|STANDARD_ERROR_OF_MEAN|0.9|<|0.0001|TWO_SIDED|95.0|2.69|6.23|||ANCOVA|||Week 16, Bodily Pain: Analysis performed using ANCOVA model which included fixed effects of treatment group, stratification factor derived from clinical database, and baseline value.||6.23|2.69|<0.0001
72422687|NCT03502616|144356415|SUPERIORITY||LS mean difference|3.24|STANDARD_ERROR_OF_MEAN|0.781|<|0.0001|TWO_SIDED|95.0|1.7|4.78|||ANCOVA|||Week 16, General Health: Analysis performed using ANCOVA model which included fixed effects of treatment group, stratification factor derived from clinical database, and baseline value.||4.78|1.70|<0.0001
72422688|NCT03502616|144356415|SUPERIORITY||LS mean difference|1.78|STANDARD_ERROR_OF_MEAN|1.098||0.1065|TWO_SIDED|95.0|-0.38|3.94|||ANCOVA|||Week 16, Vitality: Analysis performed using ANCOVA model which included fixed effects of treatment group, stratification factor derived from clinical database, and baseline value.||3.94|-0.38|0.1065
72331776|NCT01942668|144188441|SUPERIORITY||Mean Difference (Final Values)|-2.46|STANDARD_ERROR_OF_MEAN|2.166||0.255|TWO_SIDED|95.0|-6.71|1.78||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||1.78|-6.71|0.255
72331777|NCT01942668|144188441|SUPERIORITY||Mean Difference (Final Values)|-2.27|STANDARD_ERROR_OF_MEAN|2.154||0.293|TWO_SIDED|95.0|-6.49|1.96||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||1.96|-6.49|0.293
72331778|NCT01942668|144188441|SUPERIORITY||Mean Difference (Final Values)|-1.44|STANDARD_ERROR_OF_MEAN|2.148||0.502|TWO_SIDED|95.0|-5.66|2.77||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||2.77|-5.66|0.502
72422689|NCT03502616|144356415|SUPERIORITY||LS mean difference|2.96|STANDARD_ERROR_OF_MEAN|1.059||0.0055|TWO_SIDED|95.0|0.88|5.05|||ANCOVA|||Week 16, Social Functioning: Analysis performed using ANCOVA model which included fixed effects of treatment group, stratification factor derived from clinical database, and baseline value.||5.05|0.88|0.0055
72422690|NCT03502616|144356415|SUPERIORITY||LS mean difference|2.08|STANDARD_ERROR_OF_MEAN|1.289||0.1084|TWO_SIDED|95.0|-0.46|4.61|||ANCOVA|||Week 16, Role-Emotional: Analysis performed using ANCOVA model which included fixed effects of treatment group, stratification factor derived from clinical database, and baseline value.||4.61|-0.46|0.1084
72422691|NCT03502616|144356415|SUPERIORITY||LS mean difference|1.08|STANDARD_ERROR_OF_MEAN|1.124||0.3379|TWO_SIDED|95.0|-1.13|3.29|||ANCOVA|||Week 16, Mental Health: Analysis performed using ANCOVA model which included fixed effects of treatment group, stratification factor derived from clinical database, and baseline value.||3.29|-1.13|0.3379
72331779|NCT01942668|144188441|SUPERIORITY||Mean Difference (Final Values)|-1.47|STANDARD_ERROR_OF_MEAN|2.161||0.495|TWO_SIDED|95.0|-5.71|2.76||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||2.76|-5.71|0.495
72331780|NCT01942668|144188442|SUPERIORITY||Mean Difference (Final Values)|-1.96|STANDARD_ERROR_OF_MEAN|2.274||0.389|TWO_SIDED|95.0|-6.42|2.5||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||2.50|-6.42|0.389
72422692|NCT03502616|144356415|SUPERIORITY||LS mean difference|3.55|STANDARD_ERROR_OF_MEAN|0.744|<|0.0001|TWO_SIDED|95.0|2.09|5.02|||ANCOVA|||Week 16, Physical Component Summary: Analysis performed using ANCOVA model which included fixed effects of treatment group, stratification factor derived from clinical database, and baseline value.||5.02|2.09|<0.0001
72422693|NCT03502616|144356415|SUPERIORITY||LS mean difference|1.33|STANDARD_ERROR_OF_MEAN|1.158||0.2529|TWO_SIDED|95.0|-0.95|3.61|||ANCOVA|||Week 16, Mental Component Summary: Analysis performed using ANCOVA model which included fixed effects of treatment group, stratification factor derived from clinical database, and baseline value.||3.61|-0.95|0.2529
72422694|NCT03502616|144356415|SUPERIORITY||LS mean difference|0.86|STANDARD_ERROR_OF_MEAN|0.964||0.3744|TWO_SIDED|95.0|-1.04|2.76|||Mixed Models Analysis|||Week 48, Physical Functioning: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||2.76|-1.04|0.3744
72422695|NCT03502616|144356415|SUPERIORITY||LS mean difference|1.36|STANDARD_ERROR_OF_MEAN|1.083||0.2091|TWO_SIDED|95.0|-0.77|3.5|||Mixed Models Analysis|||Week 48, Role-Physical: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||3.50|-0.77|0.2091
72422696|NCT03502616|144356415|SUPERIORITY||LS mean difference|2.12|STANDARD_ERROR_OF_MEAN|1.146||0.0654|TWO_SIDED|95.0|-0.14|4.38|||Mixed Models Analysis|||Week 48, Bodily Pain: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||4.38|-0.14|0.0654
72422697|NCT03502616|144356415|SUPERIORITY||LS mean difference|1.22|STANDARD_ERROR_OF_MEAN|0.968||0.21|TWO_SIDED|95.0|-0.69|3.12|||Mixed Models Analysis|||Week 48, General Health: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||3.12|-0.69|0.2100
72422698|NCT03502616|144356415|SUPERIORITY||LS mean difference|0.56|STANDARD_ERROR_OF_MEAN|1.248||0.6568|TWO_SIDED|95.0|-1.9|3.01|||Mixed Models Analysis|||Week 48, Vitality: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||3.01|-1.90|0.6568
72422699|NCT03502616|144356415|SUPERIORITY||LS mean difference|1.39|STANDARD_ERROR_OF_MEAN|1.152||0.2288|TWO_SIDED|95.0|-0.88|3.66|||Mixed Models Analysis|||Week 48, Social Functioning: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||3.66|-0.88|0.2288
72331781|NCT01942668|144188442|SUPERIORITY||Mean Difference (Final Values)|-2.43|STANDARD_ERROR_OF_MEAN|2.253||0.281|TWO_SIDED|95.0|-6.85|1.99||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||1.99|-6.85|0.281
72331782|NCT01942668|144188442|SUPERIORITY||Mean Difference (Final Values)|-1.51|STANDARD_ERROR_OF_MEAN|2.25||0.504|TWO_SIDED|95.0|-5.92|2.91||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||2.91|-5.92|0.504
72422700|NCT03502616|144356415|SUPERIORITY||LS mean difference|0.85|STANDARD_ERROR_OF_MEAN|1.25||0.4955|TWO_SIDED|95.0|-1.61|3.32|||Mixed Models Analysis|||Week 48, Role-Emotional: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||3.32|-1.61|0.4955
72422701|NCT03502616|144356415|SUPERIORITY||LS mean difference|0.65|STANDARD_ERROR_OF_MEAN|1.2||0.5888|TWO_SIDED|95.0|-1.71|3.01|||Mixed Models Analysis|||Week 48, Mental Health: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||3.01|-1.71|0.5888
72422702|NCT03502616|144356415|SUPERIORITY||LS mean difference|1.42|STANDARD_ERROR_OF_MEAN|0.896||0.115|TWO_SIDED|95.0|-0.35|3.18|||Mixed Models Analysis|||Week 48, Physical Component Summary: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||3.18|-0.35|0.1150
72422703|NCT03502616|144356415|SUPERIORITY||LS mean difference|0.72|STANDARD_ERROR_OF_MEAN|1.158||0.5347|TWO_SIDED|95.0|-1.56|3.0|||Mixed Models Analysis|||Week 48, Mental Component Summary: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||3.00|-1.56|0.5347
72422704|NCT03502616|144356416|SUPERIORITY||LS mean difference|1.29|STANDARD_ERROR_OF_MEAN|0.898||0.1513|TWO_SIDED|95.0|-0.48|3.06|||Mixed Models Analysis|||Week 2: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||3.06|-0.48|0.1513
72331783|NCT01942668|144188442|SUPERIORITY||Mean Difference (Final Values)|-1.68|STANDARD_ERROR_OF_MEAN|2.277||0.46|TWO_SIDED|95.0|-6.15|2.78||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||2.78|-6.15|0.460
72331784|NCT01942668|144188443|SUPERIORITY||Mean Difference (Final Values)|4.35|STANDARD_ERROR_OF_MEAN|2.513||0.084|TWO_SIDED|95.0|-0.58|9.28||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||9.28|-0.58|0.084
72331785|NCT01942668|144188443|SUPERIORITY||Mean Difference (Final Values)|2.61|STANDARD_ERROR_OF_MEAN|2.506||0.298|TWO_SIDED|95.0|-2.3|7.53||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||7.53|-2.30|0.298
72331786|NCT01942668|144188443|SUPERIORITY||Mean Difference (Final Values)|3.72|STANDARD_ERROR_OF_MEAN|2.496||0.136|TWO_SIDED|95.0|-1.17|8.62||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||8.62|-1.17|0.136
72331787|NCT01942668|144188443|SUPERIORITY||Mean Difference (Final Values)|3.48|STANDARD_ERROR_OF_MEAN|2.492||0.163|TWO_SIDED|95.0|-1.41|8.37||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||8.37|-1.41|0.163
72331788|NCT01942668|144188444|SUPERIORITY||Mean Difference (Final Values)|5.11|STANDARD_ERROR_OF_MEAN|2.647||0.054|TWO_SIDED|95.0|-0.08|10.31||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||10.31|-0.08|0.054
72331789|NCT01942668|144188444|SUPERIORITY||Mean Difference (Final Values)|7.1|STANDARD_ERROR_OF_MEAN|2.634||0.007|TWO_SIDED|95.0|1.93|12.26||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||12.26|1.93|0.007
72331790|NCT01942668|144188444|SUPERIORITY||Mean Difference (Final Values)|5.9|STANDARD_ERROR_OF_MEAN|2.623||0.025|TWO_SIDED|95.0|0.75|11.04||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||11.04|0.75|0.025
72331791|NCT01942668|144188444|SUPERIORITY||Mean Difference (Final Values)|8.38|STANDARD_ERROR_OF_MEAN|2.638||0.002|TWO_SIDED|95.0|3.2|13.55||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||13.55|3.20|0.002
72331792|NCT01942668|144188445|SUPERIORITY||Mean Difference (Final Values)|5.02|STANDARD_ERROR_OF_MEAN|2.945||0.089|TWO_SIDED|95.0|-0.76|10.8||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||10.80|-0.76|0.089
72331793|NCT01942668|144188445|SUPERIORITY||Mean Difference (Final Values)|7.56|STANDARD_ERROR_OF_MEAN|2.92||0.01|TWO_SIDED|95.0|1.83|13.29||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||13.29|1.83|0.010
72331794|NCT01942668|144188445|SUPERIORITY||Mean Difference (Final Values)|7.65|STANDARD_ERROR_OF_MEAN|2.911||0.009|TWO_SIDED|95.0|1.94|13.36||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||13.36|1.94|0.009
72331795|NCT01942668|144188445|SUPERIORITY||Mean Difference (Final Values)|7.89|STANDARD_ERROR_OF_MEAN|2.944||0.007|TWO_SIDED|95.0|2.11|13.67||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||13.67|2.11|0.007
72331796|NCT01942668|144188446|SUPERIORITY||Mean Difference (Final Values)|-1.64|STANDARD_ERROR_OF_MEAN|1.749||0.349|TWO_SIDED|95.0|-5.07|1.79||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||1.79|-5.07|0.349
72331797|NCT01942668|144188446|SUPERIORITY||Mean Difference (Final Values)|-1.18|STANDARD_ERROR_OF_MEAN|1.743||0.499|TWO_SIDED|95.0|-4.6|2.24||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||2.24|-4.60|0.499
72331798|NCT01942668|144188446|SUPERIORITY||Mean Difference (Final Values)|0.14|STANDARD_ERROR_OF_MEAN|1.737||0.936|TWO_SIDED|95.0|-3.27|3.55||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||3.55|-3.27|0.936
72331799|NCT01942668|144188446|SUPERIORITY||Mean Difference (Final Values)|-0.68|STANDARD_ERROR_OF_MEAN|1.736||0.696|TWO_SIDED|95.0|-4.08|2.72||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||2.72|-4.08|0.696
72331800|NCT01942668|144188447|SUPERIORITY||Mean Difference (Final Values)|-1.09|STANDARD_ERROR_OF_MEAN|1.924||0.572|TWO_SIDED|95.0|-4.86|2.69||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||2.69|-4.86|0.572
72331801|NCT01942668|144188447|SUPERIORITY||Mean Difference (Final Values)|-1.14|STANDARD_ERROR_OF_MEAN|1.914||0.553|TWO_SIDED|95.0|-4.89|2.62||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||2.62|-4.89|0.553
72331802|NCT01942668|144188447|SUPERIORITY||Mean Difference (Final Values)|-1.42|STANDARD_ERROR_OF_MEAN|1.907||0.456|TWO_SIDED|95.0|-5.16|2.32||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||2.32|-5.16|0.456
72331803|NCT01942668|144188447|SUPERIORITY||Mean Difference (Final Values)|-0.12|STANDARD_ERROR_OF_MEAN|1.919||0.949|TWO_SIDED|95.0|-3.89|3.64||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||3.64|-3.89|0.949
72331804|NCT01942668|144188448|SUPERIORITY||Mean Difference (Final Values)|-3.36|STANDARD_ERROR_OF_MEAN|2.026||0.097|TWO_SIDED|95.0|-7.34|0.61||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||0.61|-7.34|0.097
72331805|NCT01942668|144188448|SUPERIORITY||Mean Difference (Final Values)|-5.34|STANDARD_ERROR_OF_MEAN|2.01||0.008|TWO_SIDED|95.0|-9.28|-1.4||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||-1.40|-9.28|0.008
72331806|NCT01942668|144188448|SUPERIORITY||Mean Difference (Final Values)|-4.94|STANDARD_ERROR_OF_MEAN|2.003||0.014|TWO_SIDED|95.0|-8.87|-1.01||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||-1.01|-8.87|0.014
72331807|NCT01942668|144188448|SUPERIORITY||Mean Difference (Final Values)|-3.88|STANDARD_ERROR_OF_MEAN|2.029||0.056|TWO_SIDED|95.0|-7.86|0.1||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||0.10|-7.86|0.056
72331808|NCT01942668|144188449|SUPERIORITY||Mean Difference (Final Values)|-4.92|STANDARD_ERROR_OF_MEAN|1.665||0.003|TWO_SIDED|95.0|-8.18|-1.65||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||-1.65|-8.18|0.003
72331809|NCT01942668|144188449|SUPERIORITY||Mean Difference (Final Values)|-3.79|STANDARD_ERROR_OF_MEAN|1.66||0.023|TWO_SIDED|95.0|-7.05|-0.53||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||-0.53|-7.05|0.023
72331810|NCT01942668|144188449|SUPERIORITY||Mean Difference (Final Values)|-3.28|STANDARD_ERROR_OF_MEAN|1.653||0.047|TWO_SIDED|95.0|-6.52|-0.04||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||-0.04|-6.52|0.047
72331811|NCT01942668|144188449|SUPERIORITY||Mean Difference (Final Values)|-3.41|STANDARD_ERROR_OF_MEAN|1.652||0.039|TWO_SIDED|95.0|-6.65|-0.17||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||-0.17|-6.65|0.039
72331812|NCT01942668|144188450|SUPERIORITY||Mean Difference (Final Values)|-5.69|STANDARD_ERROR_OF_MEAN|1.713|<|0.001|TWO_SIDED|95.0|-9.05|-2.33||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||-2.33|-9.05|<0.001
72331813|NCT01942668|144188450|SUPERIORITY||Mean Difference (Final Values)|-5.58|STANDARD_ERROR_OF_MEAN|1.704||0.001|TWO_SIDED|95.0|-8.93|-2.24||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||-2.24|-8.93|0.001
72331814|NCT01942668|144188450|SUPERIORITY||Mean Difference (Final Values)|-5.12|STANDARD_ERROR_OF_MEAN|1.697||0.003|TWO_SIDED|95.0|-8.45|-1.79||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||-1.79|-8.45|0.003
72331815|NCT01942668|144188450|SUPERIORITY||Mean Difference (Final Values)|-5.11|STANDARD_ERROR_OF_MEAN|1.708||0.003|TWO_SIDED|95.0|-8.46|-1.76||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||-1.76|-8.46|0.003
72331816|NCT01942668|144188451|SUPERIORITY||Mean Difference (Final Values)|-6.01|STANDARD_ERROR_OF_MEAN|1.885||0.001|TWO_SIDED|95.0|-9.71|-2.32||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||-2.32|-9.71|0.001
72331817|NCT01942668|144188451|SUPERIORITY||Mean Difference (Final Values)|-7.22|STANDARD_ERROR_OF_MEAN|1.871|<|0.001|TWO_SIDED|95.0|-10.89|-3.55||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||-3.55|-10.89|<0.001
72422705|NCT03502616|144356416|SUPERIORITY||LS mean difference|1.56|STANDARD_ERROR_OF_MEAN|1.02||0.1279|TWO_SIDED|95.0|-0.45|3.56|||Mixed Models Analysis|||Week 4: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||3.56|-0.45|0.1279
72331818|NCT01942668|144188451|SUPERIORITY||Mean Difference (Final Values)|-6.92|STANDARD_ERROR_OF_MEAN|1.863|<|0.001|TWO_SIDED|95.0|-10.58|-3.27||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||-3.27|-10.58|<0.001
72331819|NCT01942668|144188451|SUPERIORITY||Mean Difference (Final Values)|-6.42|STANDARD_ERROR_OF_MEAN|1.886|<|0.001|TWO_SIDED|95.0|-10.12|-2.72||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||-2.72|-10.12|<0.001
72331820|NCT01942668|144188452|SUPERIORITY||Mean Difference (Final Values)|-4.6|STANDARD_ERROR_OF_MEAN|1.609||0.004|TWO_SIDED|95.0|-7.75|-1.44||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||-1.44|-7.75|0.004
72331821|NCT01942668|144188452|SUPERIORITY||Mean Difference (Final Values)|-3.49|STANDARD_ERROR_OF_MEAN|1.605||0.03|TWO_SIDED|95.0|-6.64|-0.34||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||-0.34|-6.64|0.030
72331822|NCT01942668|144188452|SUPERIORITY||Mean Difference (Final Values)|-3.15|STANDARD_ERROR_OF_MEAN|1.598||0.049|TWO_SIDED|95.0|-6.29|-0.02||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||-0.02|-6.29|0.049
72331823|NCT01942668|144188452|SUPERIORITY||Mean Difference (Final Values)|-2.48|STANDARD_ERROR_OF_MEAN|1.597||0.121|TWO_SIDED|95.0|-5.61|0.65||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||0.65|-5.61|0.121
72331824|NCT01942668|144188453|SUPERIORITY||Mean Difference (Final Values)|-5.44|STANDARD_ERROR_OF_MEAN|1.682||0.001|TWO_SIDED|95.0|-8.74|-2.14||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||-2.14|-8.74|0.001
72331825|NCT01942668|144188453|SUPERIORITY||Mean Difference (Final Values)|-5.53|STANDARD_ERROR_OF_MEAN|1.674|<|0.001|TWO_SIDED|95.0|-8.81|-2.25||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||-2.25|-8.81|<0.001
72331826|NCT01942668|144188453|SUPERIORITY||Mean Difference (Final Values)|-5.12|STANDARD_ERROR_OF_MEAN|1.667||0.002|TWO_SIDED|95.0|-8.39|-1.85||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||-1.85|-8.39|0.002
72331827|NCT01942668|144188453|SUPERIORITY||Mean Difference (Final Values)|-4.64|STANDARD_ERROR_OF_MEAN|1.677||0.006|TWO_SIDED|95.0|-7.93|-1.35||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||-1.35|-7.93|0.006
72331828|NCT01942668|144188454|SUPERIORITY||Mean Difference (Final Values)|-6.28|STANDARD_ERROR_OF_MEAN|1.849|<|0.001|TWO_SIDED|95.0|-9.91|-2.65||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||-2.65|-9.91|<0.001
72331829|NCT01942668|144188454|SUPERIORITY||Mean Difference (Final Values)|-7.58|STANDARD_ERROR_OF_MEAN|1.835|<|0.001|TWO_SIDED|95.0|-11.18|-3.98||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||-3.98|-11.18|<0.001
72331830|NCT01942668|144188454|SUPERIORITY||Mean Difference (Final Values)|-7.43|STANDARD_ERROR_OF_MEAN|1.828|<|0.001|TWO_SIDED|95.0|-11.02|-3.84||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||-3.84|-11.02|<0.001
72331831|NCT01942668|144188454|SUPERIORITY||Mean Difference (Final Values)|-6.54|STANDARD_ERROR_OF_MEAN|1.851|<|0.001|TWO_SIDED|95.0|-10.17|-2.91||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||-2.91|-10.17|<0.001
72331832|NCT01942668|144188455|SUPERIORITY||Mean Difference (Final Values)|0.06|STANDARD_ERROR_OF_MEAN|0.049||0.225|TWO_SIDED|95.0|-0.04|0.16||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||0.16|-0.04|0.225
72422706|NCT03502616|144356416|SUPERIORITY||LS mean difference|3.83|STANDARD_ERROR_OF_MEAN|1.056||0.0003|TWO_SIDED|95.0|1.75|5.9|||Mixed Models Analysis|||Week 8: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||5.90|1.75|0.0003
72331833|NCT01942668|144188455|SUPERIORITY||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.049||0.741|TWO_SIDED|95.0|-0.08|0.11||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||0.11|-0.08|0.741
72331834|NCT01942668|144188455|SUPERIORITY||Mean Difference (Final Values)|0.04|STANDARD_ERROR_OF_MEAN|0.049||0.414|TWO_SIDED|95.0|-0.06|0.14||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||0.14|-0.06|0.414
72331835|NCT01942668|144188455|SUPERIORITY||Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.049||0.69|TWO_SIDED|95.0|-0.11|0.08||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||0.08|-0.11|0.690
72331836|NCT01942668|144188456|SUPERIORITY||Mean Difference (Final Values)|0.11|STANDARD_ERROR_OF_MEAN|0.052||0.045|TWO_SIDED|95.0|0.0|0.21||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||0.21|0.00|0.045
72331837|NCT01942668|144188456|SUPERIORITY||Mean Difference (Final Values)|0.09|STANDARD_ERROR_OF_MEAN|0.052||0.069|TWO_SIDED|95.0|-0.01|0.2||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||0.20|-0.01|0.069
72331838|NCT01942668|144188456|SUPERIORITY||Mean Difference (Final Values)|0.08|STANDARD_ERROR_OF_MEAN|0.052||0.126|TWO_SIDED|95.0|-0.02|0.18||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||0.18|-0.02|0.126
72331839|NCT01942668|144188456|SUPERIORITY||Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.052||0.907|TWO_SIDED|95.0|-0.1|0.11||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||0.11|-0.10|0.907
72331840|NCT01942668|144188457|SUPERIORITY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.055||0.992|TWO_SIDED|95.0|-0.11|0.11||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||0.11|-0.11|0.992
72331841|NCT01942668|144188457|SUPERIORITY||Mean Difference (Final Values)|0.04|STANDARD_ERROR_OF_MEAN|0.054||0.45|TWO_SIDED|95.0|-0.07|0.15||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||0.15|-0.07|0.450
72331842|NCT01942668|144188457|SUPERIORITY||Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.054||0.663|TWO_SIDED|95.0|-0.13|0.08||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||0.08|-0.13|0.663
72331843|NCT01942668|144188457|SUPERIORITY||Mean Difference (Final Values)|-0.06|STANDARD_ERROR_OF_MEAN|0.055||0.309|TWO_SIDED|95.0|-0.16|0.05||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||0.05|-0.16|0.309
72331844|NCT01200407|144188468|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-35.8||||0|TWO_SIDED|95.0|-37.2|-34.4|||t-test, 2 sided|||SBP with LOCF (Week 12)||-34.4|-37.2|0.000
72331845|NCT01200407|144188468|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-19.4||||0|TWO_SIDED|95.0|-20.3|-18.6|||t-test, 2 sided|||DBP with LOCF (Week 12)||-18.6|-20.3|0.000
72331846|NCT01200407|144188469|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-24.7||||0|TWO_SIDED|95.0|-26.1|-23.4|||t-test, 2 sided|||SBP w/o LOCF (Week 4)||-23.4|-26.1|0.000
72331847|NCT01200407|144188469|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-33.0||||0|TWO_SIDED|95.0|-34.4|-31.6|||t-test, 2 sided|||SBP w/o LOCF (Week 8)||-31.6|-34.4|0.000
72422707|NCT03502616|144356416|SUPERIORITY||LS mean difference|3.32|STANDARD_ERROR_OF_MEAN|1.282||0.0102|TWO_SIDED|95.0|0.79|5.84|||Mixed Models Analysis|||Week 12: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||5.84|0.79|0.0102
72422708|NCT03502616|144356416|SUPERIORITY||LS mean difference|4.73|STANDARD_ERROR_OF_MEAN|1.285||0.0003|TWO_SIDED|95.0|2.2|7.26|||Mixed Models Analysis|||Week 16: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||7.26|2.20|0.0003
72331848|NCT01200407|144188469|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-36.3||||0|TWO_SIDED|95.0|-37.9|-34.7|||t-test, 2 sided|||SBP w/o LOCF (Week 12)||-34.7|-37.9|0.000
72331849|NCT01200407|144188469|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-13.2||||0|TWO_SIDED|95.0|-14.0|-12.4|||t-test, 2 sided|||DBP w/o LOCF (Week 4)||-12.4|-14.0|0.000
72331850|NCT01200407|144188469|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-17.6||||0|TWO_SIDED|95.0|-18.4|-16.7|||t-test, 2 sided|||DBP w/o LOCF (Week 8)||-16.7|-18.4|0.000
72331851|NCT01200407|144188469|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-19.9||||0|TWO_SIDED|95.0|-20.8|-18.9|||t-test, 2 sided|||DBP w/o LOCF (Week 12)||-18.9|-20.8|0.000
72331852|NCT00853242|144188555|SUPERIORITY_OR_OTHER|||||||0.0249|TWO_SIDED||||||Wilcoxon Rank Sum Tests|||Analysis was performed using Wilcoxon rank sum tests.||||0.0249
72331853|NCT00853242|144188555|SUPERIORITY_OR_OTHER|||||||0.0001|TWO_SIDED||||||Wilcoxon Rank Sum Tests|||Analysis was performed using Wilcoxon rank sum tests.||||0.0001
72331854|NCT00853242|144188555|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Wilcoxon Rank Sum Tests|||Analysis was performed using Wilcoxon rank sum tests.||||<0.0001
72331855|NCT00853242|144188556|SUPERIORITY_OR_OTHER|||||||0.2647|TWO_SIDED||||||Wilcoxon Rank Sum Tests|||Analysis was performed using Wilcoxon rank sum tests.||||0.2647
72422709|NCT03502616|144356416|SUPERIORITY||LS mean difference|0.19|STANDARD_ERROR_OF_MEAN|1.439||0.895|TWO_SIDED|95.0|-2.64|3.02|||Mixed Models Analysis|||Week 24: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||3.02|-2.64|0.8950
72331856|NCT00853242|144188556|SUPERIORITY_OR_OTHER|||||||0.7944|TWO_SIDED||||||Wilcoxon Rank Sum Tests|||Analysis was performed using Wilcoxon rank sum tests.||||0.7944
72331857|NCT00853242|144188556|SUPERIORITY_OR_OTHER|||||||0.3724|TWO_SIDED||||||Wilcoxon Rank Sum Tests|||Analysis was performed using Wilcoxon rank sum tests.||||0.3724
72331858|NCT03497975|144188560|SUPERIORITY||Odds Ratio (OR)|2.1||||0.0309|TWO_SIDED|95.0|1.07|4.13||Logistic regression model includes WI-NRS baseline score as a covariate, treatment and the study site (with pooling) as a fixed effect.|Regression, Logistic|||||4.13|1.07|0.0309
72331859|NCT03497975|144188561|SUPERIORITY||Difference in LS Mean|-7.06|STANDARD_ERROR_OF_MEAN|1.91||0.0002|TWO_SIDED|95.0|-10.82|-3.3||Repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline ItchyQoL value. An unstructured covariance matrix is used.|Mixed Model for Repeated Measurements|||||-3.30|-10.82|0.0002
72331860|NCT03497975|144188562|SUPERIORITY||Odds Ratio (OR)|1.85||||0.0179|TWO_SIDED|95.0|1.11|3.07||Logistic regression model includes PAS (Item 5a) baseline score as a covariate, treatment as a fixed effect and the study site (with pooling) as a fixed effect.|Regression, Logistic|||||3.07|1.11|0.0179
72331861|NCT03497975|144188563|SUPERIORITY||Difference in LS Mean|-4.43|STANDARD_ERROR_OF_MEAN|1.08|<|0.0001|TWO_SIDED|95.0|-6.55|-2.31||Repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline PROMIS value. An unstructured covariance matrix is used.|Mixed Model for Repeated Measurements|||||-2.31|-6.55|<0.0001
72331862|NCT01257230|144188572|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.134|STANDARD_ERROR_OF_MEAN|0.051||0.0085|TWO_SIDED|95.0|0.034|0.234|||Mixed Models Analysis||Difference calculated as Tio R2.5 minus placebo|||0.234|0.034|0.0085
72331863|NCT01257230|144188572|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.174|STANDARD_ERROR_OF_MEAN|0.05||0.0005|TWO_SIDED|95.0|0.076|0.272|||Mixed Models Analysis||Difference calculated as Tio R5 minus placebo|||0.272|0.076|0.0005
72331864|NCT01257230|144188573|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.084|STANDARD_ERROR_OF_MEAN|0.056||0.1307|TWO_SIDED|95.0|-0.025|0.194|||Mixed Models Analysis||Difference calculated as Tio R2.5 minus placebo|||0.194|-0.025|0.1307
72331865|NCT01257230|144188573|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.117|STANDARD_ERROR_OF_MEAN|0.054||0.032|TWO_SIDED|95.0|0.01|0.223|||Mixed Models Analysis||Difference calculated as Tio R5 minus placebo|||0.223|0.010|0.0320
72331866|NCT01257230|144188574|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.088|STANDARD_ERROR_OF_MEAN|0.057||0.1231|TWO_SIDED|95.0|-0.024|0.2|||Mixed Models Analysis||Difference calculated as Tio R2.5 minus placebo|||0.200|-0.024|0.1231
72331867|NCT01257230|144188574|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.072|STANDARD_ERROR_OF_MEAN|0.056||0.195|TWO_SIDED|95.0|-0.037|0.182|||Mixed Models Analysis||Difference calculated as Tio R5 minus placebo|||0.182|-0.037|0.1950
72331868|NCT01257230|144188575|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.063|STANDARD_ERROR_OF_MEAN|0.06||0.2921|TWO_SIDED|95.0|-0.055|0.181|||Mixed Models Analysis||Difference calculated as Tio R2.5 minus placebo|||0.181|-0.055|0.2921
72331869|NCT01257230|144188575|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.035|STANDARD_ERROR_OF_MEAN|0.059||0.5495|TWO_SIDED|95.0|-0.08|0.15|||Mixed Models Analysis||Difference calculated as Tio R5 minus placebo|||0.150|-0.080|0.5495
72331870|NCT01257230|144188576|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.13|STANDARD_ERROR_OF_MEAN|0.049||0.0079|TWO_SIDED|95.0|0.034|0.225|||Mixed Models Analysis||Difference calculated as Tio R2.5 minus placebo|||0.225|0.034|0.0079
72331871|NCT01257230|144188576|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.181|STANDARD_ERROR_OF_MEAN|0.048||0.0002|TWO_SIDED|95.0|0.088|0.275|||Mixed Models Analysis||Difference calculated as Tio R5 minus placebo|||0.275|0.088|0.0002
72331872|NCT01257230|144188577|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.09|STANDARD_ERROR_OF_MEAN|0.054||0.0945|TWO_SIDED|95.0|-0.016|0.196|||Mixed Models Analysis||Difference calculated as Tio R2.5 minus placebo|||0.196|-0.016|0.0945
72331873|NCT01257230|144188577|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.071|STANDARD_ERROR_OF_MEAN|0.053||0.1755|TWO_SIDED|95.0|-0.032|0.175|||Mixed Models Analysis||Difference calculated as Tio R5 minus placebo|||0.175|-0.032|0.1755
72331874|NCT01257230|144188579|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.003|STANDARD_ERROR_OF_MEAN|0.092||0.976|TWO_SIDED|95.0|-0.184|0.178|||Mixed Models Analysis||Difference calculated as Tio R2.5 minus placebo|||0.178|-0.184|0.9760
72331875|NCT01257230|144188579|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.009|STANDARD_ERROR_OF_MEAN|0.09||0.9224|TWO_SIDED|95.0|-0.186|0.168|||Mixed Models Analysis||Difference calculated as Tio R5 minus placebo|||0.168|-0.186|0.9224
72331876|NCT01257230|144188580|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.023|STANDARD_ERROR_OF_MEAN|0.083||0.7852|TWO_SIDED|95.0|-0.14|0.185|||Mixed Models Analysis||Difference calculated as Tio R2.5 minus placebo|||0.185|-0.140|0.7852
72331877|NCT01257230|144188580|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.112|STANDARD_ERROR_OF_MEAN|0.081||0.1649|TWO_SIDED|95.0|-0.046|0.271|||Mixed Models Analysis||Difference calculated as Tio R5 minus placebo|||0.271|-0.046|0.1649
72331878|NCT01257230|144188581|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.032|STANDARD_ERROR_OF_MEAN|0.143||0.8253|TWO_SIDED|95.0|-0.312|0.249|||Mixed Models Analysis||Difference calculated as Tio R2.5 minus placebo|||0.249|-0.312|0.8253
72331879|NCT01257230|144188581|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.044|STANDARD_ERROR_OF_MEAN|0.14||0.7559|TWO_SIDED|95.0|-0.232|0.319|||Mixed Models Analysis||Difference calculated as Tio R5 minus placebo|||0.319|-0.232|0.7559
72331880|NCT01257230|144188582|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.16|STANDARD_ERROR_OF_MEAN|0.087||0.0653|TWO_SIDED|95.0|-0.33|0.01|||Mixed Models Analysis||Difference calculated as Tio R2.5 minus placebo|||0.010|-0.330|0.0653
72331881|NCT01257230|144188582|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.097|STANDARD_ERROR_OF_MEAN|0.084||0.2516|TWO_SIDED|95.0|-0.263|0.069|||Mixed Models Analysis||Difference calculated as Tio R5 minus placebo|||0.069|-0.263|0.2516
72331882|NCT01257230|144188584|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.147|STANDARD_ERROR_OF_MEAN|0.095||0.12|TWO_SIDED|95.0|-0.333|0.038|||Mixed Models Analysis||Difference calculated as Tio R2.5 minus placebo|||0.038|-0.333|0.1200
72331883|NCT01257230|144188584|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.054|STANDARD_ERROR_OF_MEAN|0.092||0.5589|TWO_SIDED|95.0|-0.235|0.127|||Mixed Models Analysis||Difference calculated as Tio R5 minus placebo|||0.127|-0.235|0.5589
72331884|NCT01257230|144188586|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.63||||0.4023|TWO_SIDED|95.0|0.21|1.87|||Regression, Cox|||||1.87|0.21|0.4023
72331885|NCT01257230|144188586|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.23||||0.062|TWO_SIDED|95.0|0.05|1.08|||Regression, Cox|||||1.08|0.05|0.0620
72331886|NCT01257230|144188587|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.04||||0.87|TWO_SIDED|95.0|0.65|1.66|||Regression, Cox|||||1.66|0.65|0.8700
72331887|NCT01257230|144188587|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.82||||0.4198|TWO_SIDED|95.0|0.51|1.33|||Regression, Cox|||||1.33|0.51|0.4198
72331888|NCT03070171|144188604|EQUIVALENCE|Bioequivalence was established by ensuring that the T/R ratio of AUC0-tz of free dabigatran was within the pre-specified acceptance range (80%-125%).|T/R Ratio|108.46909|||||TWO_SIDED|90.0|101.44605|115.97833|||ANOVA||Confidence intervals were calculated based on the residual error from ANOVA. Ratio calculated as Dabigatran Etexilate Tablet (T) divided by Dabigatran Etexilate capsule (R).|The statistical model was an analysis of variance (ANOVA) on the logarithmic scale including effects for 'sequence', 'subjects nested within sequences', 'period' and 'treatment'.||115.97833|101.44605|
72331889|NCT03070171|144188605|EQUIVALENCE|Bioequivalence was established by ensuring that the T/R ratio of Cmax of free dabigatran was within the pre-specified acceptance range (80%-125%).|T/R Ratio|108.9587|||||TWO_SIDED|90.0|101.78627|116.63654|||ANOVA||Confidence intervals were calculated based on the residual error from ANOVA. Ratio calculated as Dabigatran Etexilate Tablet (T) divided by Dabigatran Etexilate capsule (R).|The statistical model was an analysis of variance (ANOVA) on the logarithmic scale including effects for 'sequence', 'subjects nested within sequences', 'period' and 'treatment'.||116.63654|101.78627|
72422710|NCT03502616|144356416|SUPERIORITY||LS mean difference|-0.98|STANDARD_ERROR_OF_MEAN|1.365||0.4732|TWO_SIDED|95.0|-3.67|1.71|||Mixed Models Analysis|||Week 32: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||1.71|-3.67|0.4732
72422711|NCT03502616|144356416|SUPERIORITY||LS mean difference|-0.72|STANDARD_ERROR_OF_MEAN|1.523||0.6359|TWO_SIDED|95.0|-3.72|2.28|||Mixed Models Analysis|||Week 40: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||2.28|-3.72|0.6359
72331890|NCT03070171|144188606|EQUIVALENCE|Bioequivalence was established by ensuring that the T/R ratio of Cmax of free dabigatran was within the pre-specified acceptance range (80%-125%).|T/R Ratio|107.61507|||||TWO_SIDED|90.0|100.61938|115.09714|||ANOVA||Confidence intervals were calculated based on the residual error from ANOVA. Ratio calculated as Dabigatran Etexilate Tablet (T) divided by Dabigatran Etexilate capsule (R).|The statistical model was an analysis of variance (ANOVA) on the logarithmic scale including effects for 'sequence', 'subjects nested within sequences', 'period' and 'treatment'.||115.09714|100.61938|
72331891|NCT03070171|144188607|EQUIVALENCE|Bioequivalence was established by ensuring that the T/R ratio of Cmax of total dabigatran was within the pre-specified acceptance range (80%-125%).|T/R Ratio|106.69566|||||TWO_SIDED|90.0|99.50139|114.4101|||ANOVA||Confidence intervals were calculated based on the residual error from ANOVA. Ratio calculated as Dabigatran Etexilate Tablet (T) divided by Dabigatran Etexilate capsule (R).|The statistical model was an analysis of variance (ANOVA) on the logarithmic scale including effects for 'sequence', 'subjects nested within sequences', 'period' and 'treatment'.||114.41010|99.50139|
72331892|NCT03070171|144188608|EQUIVALENCE|Bioequivalence was established by ensuring that the T/R ratio of AUC0-∞ of total dabigatran was within the pre-specified acceptance range (80%-125%).|T/R Ratio|107.83324|||||TWO_SIDED|90.0|101.25584|114.8379|||ANOVA||Confidence intervals were calculated based on the residual error from ANOVA. Ratio calculated as Dabigatran Etexilate Tablet (T) divided by Dabigatran Etexilate capsule (R).|The statistical model was an analysis of variance (ANOVA) on the logarithmic scale including effects for 'sequence', 'subjects nested within sequences', 'period' and 'treatment'.||114.83790|101.25584|
72422712|NCT03502616|144356416|SUPERIORITY||LS mean difference|-0.6|STANDARD_ERROR_OF_MEAN|1.495||0.6894|TWO_SIDED|95.0|-3.54|2.35|||Mixed Models Analysis|||Week 48: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||2.35|-3.54|0.6894
72422713|NCT03502616|144356417|SUPERIORITY||LS mean difference|1.39|STANDARD_ERROR_OF_MEAN|0.94||0.141|TWO_SIDED|95.0|-0.46|3.24|||Mixed Models Analysis|||Week 2: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||3.24|-0.46|0.1410
72331893|NCT03070171|144188609|EQUIVALENCE|Bioequivalence was established by ensuring that the T/R ratio of AUC0-∞ of free dabigatran was within the pre-specified acceptance range (80%-125%).|T/R Ratio|108.43158|||||TWO_SIDED|90.0|101.87254|115.41292|||ANOVA||Confidence intervals were calculated based on the residual error from ANOVA. Ratio calculated as Dabigatran Etexilate Tablet (T) divided by Dabigatran Etexilate capsule (R).|The statistical model was an analysis of variance (ANOVA) on the logarithmic scale including effects for 'sequence', 'subjects nested within sequences', 'period' and 'treatment'.||115.41292|101.87254|
72331894|NCT01471028|144188612|SUPERIORITY||Hazard Ratio (HR)|1.027||||0.904|TWO_SIDED|95.0|0.689|1.53|||Log Rank|||The primary endpoint was assessed using a Kaplan-Meier survival analysis of the Intent-to-treat (ITT) population utilizing a log-rank test.||1.53|0.689|0.904
72331895|NCT01471028|144188613|SUPERIORITY|||||||0.737|||||||Chi-squared|||||||0.737
72331896|NCT01471028|144188614|SUPERIORITY||Hazard Ratio (HR)|1.315||||0.168|TWO_SIDED|95.0|0.886|1.952|||Log Rank|||||1.952|0.886|0.168
72422714|NCT03502616|144356417|SUPERIORITY||LS mean difference|2.78|STANDARD_ERROR_OF_MEAN|1.102||0.0122|TWO_SIDED|95.0|0.61|4.95|||Mixed Models Analysis|||Week 4: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||4.95|0.61|0.0122
72331897|NCT01471028|144188615|SUPERIORITY||Hazard Ratio (HR)|0.283||||0.007|TWO_SIDED|95.0|0.109|0.732|||Log Rank|||||0.732|0.109|0.007
72331898|NCT00683930|144188659|SUPERIORITY_OR_OTHER||Treatment difference in response rate|5.1||||0.6558||97.5|-17.4|27.6|||Fisher Exact|Alpha = 0.025||||27.6|-17.4|0.6558
72422715|NCT03502616|144356417|SUPERIORITY||LS mean difference|3.32|STANDARD_ERROR_OF_MEAN|1.252||0.0085|TWO_SIDED|95.0|0.86|5.79|||Mixed Models Analysis|||Week 8: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||5.79|0.86|0.0085
72422716|NCT03502616|144356417|SUPERIORITY||LS mean difference|3.36|STANDARD_ERROR_OF_MEAN|1.416||0.0184|TWO_SIDED|95.0|0.57|6.15|||Mixed Models Analysis|||Week 12: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||6.15|0.57|0.0184
72422717|NCT03502616|144356417|SUPERIORITY||LS mean difference|4.19|STANDARD_ERROR_OF_MEAN|1.38||0.0026|TWO_SIDED|95.0|1.47|6.91|||Mixed Models Analysis|||Week 16: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||6.91|1.47|0.0026
72331899|NCT01208961|144188667|SUPERIORITY_OR_OTHER||Ratio of Geometric Means|400.36|||<|0.001|TWO_SIDED|90.0|326.87|490.36|||ANOVA|ANOVA on log-trans baseline-adj PK values using sequence, period, and treatments as fixed effects and subject nested within sequence as random effect||Results for the analyses of the High-Fat Periods were not posted because the critical comparison was the response of Lovaza versus Epanova to the clinically relevant low-fat diet to be used as adjunct in hypertriglyceridemia.||490.36|326.87|<0.001
72331900|NCT01208961|144188668|SUPERIORITY_OR_OTHER||Ratio of Geometric Mans|649.66|||<|0.01|TWO_SIDED|90.0|511.75|824.75||ANOVA model with baseline value as covariate, and treatment and user/non-user of lipid-altering drugs as factors. LSM estimate performed on log-scale|ANOVA|||Results for the analyses of the High-Fat Periods were not posted because the critical comparison was the response of Lovaza versus Epanova to the clinically relevant low-fat diet to be used as adjunct in hypertriglyceridemia.||824.75|511.75|<0.01
72331901|NCT01208961|144188669|SUPERIORITY_OR_OTHER||Ratio of Geometric Means|369.66|||<|0.001|TWO_SIDED|90.0|301.74|452.86|||ANOVA|||Results for the analyses of the High-Fat Periods were not posted because the critical comparison was the response of Lovaza versus Epanova to the clinically relevant low-fat diet to be used as adjunct in hypertriglyceridemia.||452.86|301.74|<0.001
72331902|NCT02152371|144188673|SUPERIORITY_OR_OTHER_LEGACY||LS Means Diff|-0.77|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.97|-0.56|||Mixed Model for Repeated Measures (MMRM)|||||-0.56|-0.97|<.001
72331903|NCT02152371|144188674|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Diff|-16.73|STANDARD_ERROR_OF_MEAN|4.72|<|0.001|TWO_SIDED|95.0|-26.02|-7.44|||Mixed Models Analysis|||||-7.44|-26.02|<.001
72331904|NCT02152371|144188675|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Diff|-8.06|STANDARD_ERROR_OF_MEAN|2.95||0.007|TWO_SIDED|95.0|-13.87|-2.25|||Mixed Models Analysis|||Pre-Morning Meal||-2.25|-13.87|.007
72331905|NCT02152371|144188675|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Diff|-17.18|STANDARD_ERROR_OF_MEAN|4.45|<|0.001|TWO_SIDED|95.0|-25.96|-8.4|||Mixed Models Analysis|||Morning Meal 2-Hour Postprandial||-8.40|-25.96|<.001
72331906|NCT02152371|144188675|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Diff|-15.55|STANDARD_ERROR_OF_MEAN|4.08|<|0.001|TWO_SIDED|95.0|-23.58|-7.52|||Mixed Models Analysis|||Pre-Midday Meal||-7.52|-23.58|<.001
72331907|NCT02152371|144188675|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Diff|-18.15|STANDARD_ERROR_OF_MEAN|4.58|<|0.001|TWO_SIDED|95.0|-27.18|-9.12|||Mixed Models Analysis|||Midday Meal 2-Hour Postprandial||-9.12|-27.18|<.001
72331908|NCT02152371|144188675|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Diff|-14.96|STANDARD_ERROR_OF_MEAN|4.55||0.001|TWO_SIDED|95.0|-23.93|-5.99|||Mixed Models Analysis|||Pre-Evening Meal||-5.99|-23.93|.001
72331909|NCT02152371|144188675|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Diff|-21.28|STANDARD_ERROR_OF_MEAN|5.68|<|0.001|TWO_SIDED|95.0|-32.46|-10.1|||Mixed Models Analysis|||Evening Meal 2-Hour Postprandial||-10.10|-32.46|<.001
72331910|NCT02152371|144188675|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Diff|-19.48|STANDARD_ERROR_OF_MEAN|4.72|<|0.001|TWO_SIDED|95.0|-28.77|-10.18|||Mixed Models Analysis|||3:00AM (Morning)||-10.18|-28.77|<.001
72331911|NCT02152371|144188676|SUPERIORITY_OR_OTHER_LEGACY||LS Means Difference|-2.41|STANDARD_ERROR_OF_MEAN|0.39|<|0.001|TWO_SIDED|95.0|-3.19|-1.64|||Mixed Models Analysis|||||-1.64|-3.19|<.001
72331912|NCT02152371|144188677|SUPERIORITY_OR_OTHER_LEGACY||LS Means Diff|-13.19|STANDARD_ERROR_OF_MEAN|3.21|<|0.001|TWO_SIDED|95.0|-19.55|-6.84|||MMRM|||||-6.84|-19.55|<.001
72331913|NCT02152371|144188684|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|6.66|||<|0.001|TWO_SIDED|95.0|3.7|12.0|||Regression, Logistic|||||12.00|3.70|<.001
72331914|NCT02152371|144188684|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio, log|5.71|||<|0.001|TWO_SIDED|95.0|3.35|9.73|||Regression, Logistic|||||9.73|3.35|<.001
72331915|NCT02152371|144188685|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|4.17|||<|0.001|TWO_SIDED|95.0|2.32|7.47|||Regression, Logistic|||||7.47|2.32|<.001
72331916|NCT02152371|144188686|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|3.61|||<|0.001|TWO_SIDED|95.0|2.09|6.23|||Regression, Logistic|||||6.23|2.09|<.001
72331917|NCT02152371|144188687|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|5.6|||<|0.001|TWO_SIDED|95.0|3.26|9.62|||Regression, Logistic|||||9.62|3.26|<.001
72331918|NCT05352412|144188689|OTHER|Mann-Whitney U|Mann-Whitney U|0.32||||0.32|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.32
72331919|NCT05352412|144188689|OTHER|Mann-Whitney U|Mann-Whitney U|0.39||||0.39|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Baseline survey compared with immediate follow-up survey||||0.39
72331920|NCT05352412|144188689|OTHER|Mann-Whitney U|Mann-Whitney U|0.21||||0.21|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||2 weeks post-discharge compared with baseline survey||||0.21
72331921|NCT05352412|144188689|OTHER||Mann-Whitney U|0.19||||0.19|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||90 days post-discharge compared with baseline survey||||0.19
72331922|NCT05352412|144188689|OTHER||Mann-Whitney U|0.38||||0.38|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Baseline survey versus immediate follow-up||||0.38
72331923|NCT05352412|144188689|OTHER||Mann-Whitney U|0.25||||0.25|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||2 weeks post-discharge compared with baseline survey||||0.25
72331924|NCT05352412|144188689|OTHER||Mann-Whitney U|0.07||||0.07|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||90 days post-discharge compared with baseline survey||||0.07
72331925|NCT05352412|144188689|OTHER||Mann-Whitney U|0.03||||0.03|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Immediate follow-up between the two arms||||0.03
72331926|NCT05352412|144188689|OTHER||Mann-Whitney U|0.65||||0.65|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||2 weeks post-discharge comparison between the 2 arms||||0.65
72331927|NCT05352412|144188689|OTHER||Mann-Whitney U|0.97||||0.97|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||90-days post discharge compared between the 2 arms||||0.97
72331928|NCT05352412|144188690|OTHER||Mann-Whitney U|0.77||||0.77|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Baseline comparison between the 2 arms||||0.77
72331929|NCT05352412|144188690|OTHER||Mann-Whitney U|0.85||||0.85|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Immediate follow-up compared with baseline survey||||0.85
72331930|NCT05352412|144188690|OTHER||Mann-Whitney U|0.38||||0.38|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||2-week post-discharge compared with baseline survey||||0.38
72331931|NCT05352412|144188690|OTHER||Mann-Whitney U|0.21||||0.21|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||90-day post discharge compared with baseline survey||||0.21
72331932|NCT05352412|144188690|OTHER||Mann-Whitney U|0.32||||0.32|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Immediate follow-up compared with baseline survey||||0.32
72331933|NCT05352412|144188690|OTHER||Mann-Whitney U|0.09||||0.09|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||2 week post-discharge compared with baseline survey||||0.09
72331934|NCT05352412|144188690|OTHER||Mann-Whitney U|0.07||||0.07|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||90-day post-discharge compared with baseline survey||||0.07
72331935|NCT05352412|144188690|OTHER||Mann-Whitney U|0.26||||0.26|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||2 weeks post-discharge compared between the 2 arms||||0.26
72331936|NCT05352412|144188690|OTHER||Mann-Whitney U|0.69||||0.69|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Immediate follow-up compared between the 2 arms||||0.69
72331937|NCT05352412|144188690|OTHER||Mann-Whitney U|0.32||||0.32|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||90-day post-discharge compared between the 2 arms||||0.32
72331938|NCT05352412|144188694|OTHER|Mann-Whitney U|Mann-Whitney U|1.0||||1|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||1.00
72331939|NCT05352412|144188694|OTHER|Mann-Whitney U|Mann-Whitney U|1.0||||1|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||1.00
72331940|NCT05352412|144188694|OTHER|Mann-Whitney U|Mann-Whitney U|0.12||||0.12|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.12
72331941|NCT05352412|144188694|OTHER|Mann-Whitney U|Mann-Whitney U|0.12||||0.12|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Immediate follow-up||||0.12
72331942|NCT05352412|144188695|OTHER|Mann-Whitney U|Mann-Whitney U|0.48||||0.48|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.48
72331943|NCT05352412|144188695|OTHER|Mann-Whitney U|Mann-Whitney U|1.0||||1|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||1.00
72331944|NCT05352412|144188695|OTHER|Mann-Whitney U|Mann-Whitney U|0.17||||0.17|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.17
72331945|NCT05352412|144188695|OTHER|Mann-Whitney U|Mann-Whitney U|0.42||||0.42|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Immediate follow-up||||0.42
72331946|NCT05352412|144188696|OTHER|Mann-Whitney U|Mann-Whitney U|1.0||||1|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Baseline||||1.00
72331947|NCT05352412|144188696|OTHER|Mann-Whitney U|Mann-Whitney U|0.11||||0.11|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Baseline versus immediate follow-up||||0.11
72331948|NCT05352412|144188696|OTHER|Mann-Whitney U|Mann-Whitney U|0.89||||0.89|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Baseline versus immediate follow-up||||0.89
72331949|NCT05352412|144188696|OTHER|Mann-Whitney U|Mann-Whitney U|0.55||||0.55|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Immediate follow-up||||0.55
72331950|NCT05352412|144188697|OTHER|Mann-Whitney U|Mann-Whitney U|0.66||||0.66|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Baseline||||0.66
72331951|NCT05352412|144188697|OTHER|Mann-Whitney U|Mann-Whitney U|0.2||||0.2|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Baseline versus immediate follow-up post randomization||||0.20
72331952|NCT05352412|144188697|OTHER|Mann-Whitney U|Mann-Whitney U|0.85||||0.85|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Baseline versus immediate follow-up post randomization||||0.85
72331953|NCT05352412|144188697|OTHER|Mann-Whitney U|Mann-Whitney U|0.07||||0.07|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Immediate follow-up post randomization||||0.07
72331954|NCT06359028|144188698|SUPERIORITY||Adjusted Mean Difference|-1.94|STANDARD_ERROR_OF_MEAN|0.113|<|0.0001|TWO_SIDED|95.0|-2.16|-1.72|||Mixed Model with Repeated Measures|||||-1.72|-2.16|<0.0001
72331955|NCT06359028|144188699|SUPERIORITY||Adjusted Mean Difference|57.37|STANDARD_ERROR_OF_MEAN|3.599|<|0.0001|TWO_SIDED|95.0|50.23|64.51|||Mixed Model with Repeated Measures|||||64.51|50.23|<0.0001
72331956|NCT06359028|144188700|SUPERIORITY||Adjusted Mean Difference|-1.65|STANDARD_ERROR_OF_MEAN|0.121|<|0.0001|TWO_SIDED|95.0|-1.89|-1.41|||Mixed Model with Repeated Measures|||||-1.41|-1.89|<0.0001
72331957|NCT06359028|144188701|SUPERIORITY||Adjusted Mean Difference|35.37|STANDARD_ERROR_OF_MEAN|4.28|<|0.0001|TWO_SIDED|95.0|26.88|43.86|||Mixed Model with Repeated Measures|||||43.86|26.88|<0.0001
72331958|NCT06359028|144188702|SUPERIORITY||Adjusted Mean Difference|-0.46|STANDARD_ERROR_OF_MEAN|0.296||0.1268|TWO_SIDED|95.0|-1.04|0.13|||Mixed Model with Repeated Measures|||Q7, Day 28||0.13|-1.04|0.1268
72331959|NCT06359028|144188702|SUPERIORITY||Adjusted Mean Difference|-1.75|STANDARD_ERROR_OF_MEAN|0.316|<|0.0001|TWO_SIDED|95.0|-2.38|-1.13|||Mixed Model with Repeated Measures|||Q7, Day 56||-1.13|-2.38|<0.0001
72331960|NCT06359028|144188702|SUPERIORITY||Adjusted Mean Difference|-0.72|STANDARD_ERROR_OF_MEAN|0.315||0.0245|TWO_SIDED|95.0|-1.35|-0.09|||Mixed Model with Repeated Measures|||Q8, Day 28||-0.09|-1.35|0.0245
72331961|NCT06359028|144188702|SUPERIORITY||Adjusted Mean Difference|-1.81|STANDARD_ERROR_OF_MEAN|0.318|<|0.0001|TWO_SIDED|95.0|-2.44|-1.18|||Mixed Model with Repeated Measures|||Q8, Day 56||-1.18|-2.44|<0.0001
72331962|NCT06359028|144188702|SUPERIORITY||Adjusted Mean Difference|-0.29|STANDARD_ERROR_OF_MEAN|0.337||0.3851|TWO_SIDED|95.0|-0.96|0.37|||Mixed Model with Repeated Measures|||Q9, Day 28||0.37|-0.96|0.3851
72331963|NCT06359028|144188702|SUPERIORITY||Adjusted Mean Difference|-1.48|STANDARD_ERROR_OF_MEAN|0.375||0.0002|TWO_SIDED|95.0|-2.22|-0.73|||Mixed Model with Repeated Measures|||Q9, Day 56||-0.73|-2.22|0.0002
72331964|NCT06359028|144188703|SUPERIORITY||Adjusted Mean Difference|-6.19|STANDARD_ERROR_OF_MEAN|4.674||0.1884|TWO_SIDED|95.0|-15.46|3.08|||Mixed Model with Repeated Measures|||Day 28||3.08|-15.46|0.1884
72331965|NCT06359028|144188703|SUPERIORITY||Adjusted Mean Difference|-24.49|STANDARD_ERROR_OF_MEAN|6.308||0.0002|TWO_SIDED|95.0|-37.0|-11.97|||Mixed Model with Repeated Measures|||Day 56||-11.97|-37.00|0.0002
72331966|NCT06359028|144188704|SUPERIORITY||Adjusted Mean Difference|-0.81|STANDARD_ERROR_OF_MEAN|0.774||0.3003|TWO_SIDED|95.0|-2.34|0.73|||Mixed Model with Repeated Measures|||Day 28||0.73|-2.34|0.3003
72331967|NCT06359028|144188704|SUPERIORITY||Adjusted Mean Difference|-2.77|STANDARD_ERROR_OF_MEAN|0.903||0.0028|TWO_SIDED|95.0|-4.56|-0.97|||Mixed Model with Repeated Measures|||Day 56||-0.97|-4.56|0.0028
72331968|NCT06359028|144188705|SUPERIORITY||Adjusted Mean Difference|-3.78|STANDARD_ERROR_OF_MEAN|2.127||0.0784|TWO_SIDED|95.0|-8.0|0.44|||Mixed Model with Repeated Measures|||Day 28||0.44|-8.00|0.0784
72422718|NCT03502616|144356417|SUPERIORITY||LS mean difference|3.4|STANDARD_ERROR_OF_MEAN|1.495||0.0236|TWO_SIDED|95.0|0.46|6.35|||Mixed Models Analysis|||Week 24: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||6.35|0.46|0.0236
72331969|NCT06359028|144188705|SUPERIORITY||Adjusted Mean Difference|-8.17|STANDARD_ERROR_OF_MEAN|3.074||0.0092|TWO_SIDED|95.0|-14.27|-2.07|||Mixed Model with Repeated Measures|||Day 56||-2.07|-14.27|0.0092
72331970|NCT06359028|144188706|SUPERIORITY||Adjusted Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.846||0.8686|TWO_SIDED|95.0|-1.82|1.54|||Mixed Model with Repeated Measures|||Day 28||1.54|-1.82|0.8686
72331971|NCT06359028|144188706|SUPERIORITY||Adjusted Mean Difference|-3.24|STANDARD_ERROR_OF_MEAN|0.976||0.0012|TWO_SIDED|95.0|-5.18|-1.31|||Mixed Model with Repeated Measures|||Day 56||-1.31|-5.18|0.0012
72331972|NCT06359028|144188707|SUPERIORITY||Adjusted Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|1.444||0.9047|TWO_SIDED|95.0|-3.04|2.69|||Mixed Model with Repeated Measures|||Day 28||2.69|-3.04|0.9047
72331973|NCT06359028|144188707|SUPERIORITY||Adjusted Mean Difference|-6.66|STANDARD_ERROR_OF_MEAN|1.656||0.0001|TWO_SIDED|95.0|-9.95|-3.38|||Mixed Model with Repeated Measures|||Day 56||-3.38|-9.95|0.0001
72331974|NCT06359028|144188708|SUPERIORITY||Adjusted Mean Difference|-0.47|STANDARD_ERROR_OF_MEAN|0.84||0.5733|TWO_SIDED|95.0|-2.14|1.19|||Mixed Model with Repeated Measures|||Day 28||1.19|-2.14|0.5733
72331975|NCT06359028|144188708|SUPERIORITY||Adjusted Mean Difference|-2.88|STANDARD_ERROR_OF_MEAN|1.026||0.006|TWO_SIDED|95.0|-4.92|-0.84|||Mixed Model with Repeated Measures|||Day 56||-0.84|-4.92|0.0060
72331976|NCT06359028|144188709|SUPERIORITY||Adjusted Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.127||0.2768|TWO_SIDED|95.0|-0.39|0.11|||Mixed Model with Repeated Measures|||Day 28||0.11|-0.39|0.2768
72331977|NCT06359028|144188709|SUPERIORITY||Adjusted Mean Difference|-0.26|STANDARD_ERROR_OF_MEAN|0.113||0.0232|TWO_SIDED|95.0|-0.48|-0.04|||Mixed Model with Repeated Measures|||Day 56||-0.04|-0.48|0.0232
72331978|NCT06359028|144188710|SUPERIORITY||Adjusted Mean Difference|0.05|STANDARD_ERROR_OF_MEAN|0.403||0.8996|TWO_SIDED|95.0|-0.75|0.85|||Mixed Model with Repeated Measures|||Day 28||0.85|-0.75|0.8996
72331979|NCT06359028|144188710|SUPERIORITY||Adjusted Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|0.383||0.0204|TWO_SIDED|95.0|-1.66|-0.14|||Mixed Model with Repeated Measures|||Day 56||-0.14|-1.66|0.0204
72331980|NCT04382586|144188711|SUPERIORITY||Odds Ratio (OR)|1.61||||0.4099|TWO_SIDED|95.0|0.349|7.391|||Unstratified 1-sided Fisher's exact test|||||7.391|0.349|0.4099
72331981|NCT04382586|144188712|SUPERIORITY||Hazard Ratio (HR)|0.918||||0.7619|TWO_SIDED|95.0|0.511|1.648|||Log Rank|||||1.648|0.511|0.7619
72331982|NCT01866111|144188725|SUPERIORITY||||||<|0.001|||||||ANCOVA|||A step down procedure was used for the primary efficacy analyses to ensure the type one error rate for multiple comparisons was controlled at the 5% level using the following hierarchy: 200 mg vs placebo, 400 mg vs placebo, 100 mg vs placebo, in which a statistically significant difference had to be detected in this order for each subsequent comparison to occur.||||<0.001
72331983|NCT01866111|144188725|SUPERIORITY||||||<|0.001|||||||ANCOVA|||||||<0.001
72331984|NCT01866111|144188725|SUPERIORITY|||||||0.007|||||||ANCOVA|||||||0.007
72331985|NCT01866111|144188726|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||<0.001
72331986|NCT01866111|144188726|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||<0.001
72331987|NCT01866111|144188726|SUPERIORITY|||||||0.003|||||||Fisher Exact|||||||0.003
72331988|NCT01221623|144188737|SUPERIORITY_OR_OTHER|||||||0.0059|TWO_SIDED||||||ANOVA|||||||.0059
72331989|NCT01221623|144188738|SUPERIORITY_OR_OTHER|||||||0.0496|TWO_SIDED||||||ANOVA|||||||.0496
72331990|NCT01221623|144188739|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<.0001
72331991|NCT01221623|144188740|SUPERIORITY_OR_OTHER|||||||0.034|TWO_SIDED||||||ANOVA|||||||.0340
72331992|NCT01221623|144188741|SUPERIORITY_OR_OTHER|||||||0.1168|TWO_SIDED||||||ANOVA|||||||.1168
72331993|NCT01221623|144188742|SUPERIORITY_OR_OTHER|||||||0.0144|TWO_SIDED||||||ANOVA|||||||.0144
72331994|NCT01221623|144188743|SUPERIORITY_OR_OTHER|||||||0.0248|TWO_SIDED||||||ANOVA|||||||.0248
72331995|NCT01221623|144188744|SUPERIORITY_OR_OTHER|||||||0.6949|TWO_SIDED||||||ANOVA|||||||.6949
72331996|NCT01221623|144188745|SUPERIORITY_OR_OTHER|||||||0.0249|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||.0249
72331997|NCT03479541|144188746|OTHER|Linear mixed effect model containing fixed effects for group (earlier or later), time since injury, and group x time since injury interaction with random intercepts, covariates (age, gender, and Initial SCAT symptom severity total score), and inverse probability weights. Later Physical Therapy Group served as the reference.|Slope|-0.097||||0.013|TWO_SIDED|95.0|-0.173|-0.02||a priori threshold p \< 0.05|Mixed Models Analysis||The slope estimate is the group difference (Early Physical Therapy Group - Later Physical Therapy Group) in change per day per day (the interaction effect of the mixed model analysis).|||-0.020|-0.173|0.013
72331998|NCT03479541|144188747|OTHER|Linear mixed effect model containing fixed effects for group (earlier or later), time since injury, and group x time since injury interaction with random intercepts, covariates (age, gender, and Initial SCAT symptom severity total score), and inverse probability weights. Later Physical Therapy Group served as the reference.|Slope|-0.073||||0.013|TWO_SIDED|95.0|-0.13|-0.016||a priori threshold p \< 0.05|Mixed Models Analysis||The slope estimate is the group difference (Early Physical Therapy Group - Later Physical Therapy Group) in change per day per day (the interaction effect of the mixed model analysis).|||-0.016|-0.130|0.013
72331999|NCT03479541|144188748|OTHER|Linear mixed effect model containing fixed effects for group (earlier or later), time since injury, and group x time since injury interaction with random intercepts, covariates (age, gender, and Initial SCAT symptom severity total score), and inverse probability weights. Later Physical Therapy Group served as the reference.|Slope|0.098||||0.01|TWO_SIDED|95.0|0.024|0.173||a priori threshold p \< 0.05|Mixed Models Analysis||The slope estimate is the group difference (Early Physical Therapy Group - Later Physical Therapy Group) in change per day per day (the interaction effect of the mixed model analysis).|||0.173|0.024|0.010
72332000|NCT03479541|144188749|OTHER|||||||0.5158|||||||Wilcoxon (Mann-Whitney)|||||||0.5158
72332001|NCT03479541|144188750|OTHER|Linear mixed effect model containing fixed effects for group (earlier or later), time since injury, and group x time since injury interaction with random intercepts, covariates (age, gender, and Initial SCAT symptom severity total score), and inverse probability weights. Later Physical Therapy Group served as the reference.|Slope|0.0404||||0.45|TWO_SIDED|95.0|-0.0648|0.146||a priori threshold p \< 0.05|Mixed Models Analysis||The slope estimate is the group difference (Early Physical Therapy Group - Later Physical Therapy Group) in change per day per day (the interaction effect of the mixed model analysis).|||0.146|-0.0648|0.450
72332002|NCT03479541|144188751|OTHER|Linear mixed effect model containing fixed effects for group (earlier or later), time point (pre-physical therapy and post-physical therapy), and group x time point injury interaction with random intercepts, covariates (age, gender, Initial SCAT symptom severity total score, and days since injury before physical therapy), and inverse probability weights. Later Physical Therapy Group and pre-physical therapy time point served as the reference. Values were log-transformed for model assumptions.|Slope|0.05353||||0.6039|TWO_SIDED|95.0|-0.1503|0.2574||a priori threshold p \< 0.05|Mixed Models Analysis||The slope estimate is the group difference (Early Physical Therapy Group - Later Physical Therapy Group) in change from pre-physical therapy to post-physical therapy time points (the interaction effect of the mixed model analysis).|Analysis for Horizontal DVA Lines Lost||0.2574|-0.1503|0.6039
72332003|NCT03479541|144188751|OTHER|Linear mixed effect model containing fixed effects for group (earlier or later), time point (pre-physical therapy and post-physical therapy), and group x time point injury interaction with random intercepts, covariates (age, gender, Initial SCAT symptom severity total score, and days since injury before physical therapy), and inverse probability weights. Later Physical Therapy Group and pre-physical therapy time point served as the references. Values were log-transformed for model assumptions.|Slope|-0.235||||0.0414|TWO_SIDED|95.0|-0.461|-0.0093||a priori threshold p \< 0.05|Mixed Models Analysis||The slope estimate is the group difference (Early Physical Therapy Group - Later Physical Therapy Group) in change from pre-physical therapy to post-physical therapy time points (the interaction effect of the mixed model analysis).|Analysis for Vertical DVA Lines Lost||-0.0093|-0.461|0.0414
72332004|NCT03479541|144188752|OTHER|Linear mixed effect model containing fixed effects for group (earlier or later), time since injury, and group x time since injury interaction with random intercepts, covariates (age, gender, and Initial SCAT symptom severity total score), and inverse probability weights. Later Physical Therapy Group served as the reference.|Slope|-0.028||||0.387|TWO_SIDED|95.0|-0.09|0.035||a priori threshold p \< 0.05|Mixed Models Analysis||The slope estimate is the group difference (Early Physical Therapy Group - Later Physical Therapy Group) in change per day per day (the interaction effect of the mixed model analysis).|||0.035|-0.090|0.387
72332005|NCT03479541|144188753|OTHER|Linear mixed effect model containing fixed effects for group (earlier or later), time since injury, and group x time since injury interaction with random intercepts, covariates (age, gender, and Initial SCAT symptom severity total score), and inverse probability weights. Later Physical Therapy Group served as the reference.|Slope|0.008||||0.135|TWO_SIDED|95.0|-0.003|0.019||a priori threshold p \< 0.05|Mixed Models Analysis||The slope estimate is the group difference (Early Physical Therapy Group - Later Physical Therapy Group) in change per day per day (the interaction effect of the mixed model analysis).|||0.019|-0.003|0.135
72332006|NCT03479541|144188754|OTHER|Linear mixed effect model containing fixed effects for group (earlier or later), time since injury, and group x time since injury interaction with random intercepts, covariates (age, gender, and Initial SCAT symptom severity total score), and inverse probability weights. Later Physical Therapy Group served as the reference.|Slope|-0.0107||||0.406|TWO_SIDED|95.0|-0.036|0.0146||a priori threshold p \< 0.05|Mixed Models Analysis||||The slope estimate is the group difference (Early Physical Therapy Group - Later Physical Therapy Group) in change per day per day (the interaction effect of the mixed model analysis).|0.0146|-0.0360|0.406
72332007|NCT03479541|144188755|OTHER|Linear mixed effect model containing fixed effects for group (earlier or later), time since injury, and group x time since injury interaction with random intercepts, covariates (age, gender, and Initial SCAT symptom severity total score), and inverse probability weights. Later Physical Therapy Group served as the reference.|Slope|0.00391||||0.083|TWO_SIDED|95.0|-0.00052|0.00835||a priori threshold p \< 0.05|Mixed Models Analysis||The slope estimate is the group difference (Early Physical Therapy Group - Later Physical Therapy Group) in change per day per day (the interaction effect of the mixed model analysis).|||0.00835|-0.00052|0.083
72332008|NCT03479541|144188756|OTHER|Linear mixed effect model containing fixed effects for group (earlier or later), time since injury, and group x time since injury interaction with random intercepts, covariates (age, gender, and Initial SCAT symptom severity total score), and inverse probability weights. Later Physical Therapy Group served as the reference.|Slope|-0.003||||0.24|TWO_SIDED|95.0|-0.007|0.002||a priori threshold p \< 0.05|Mixed Models Analysis||The slope estimate is the group difference (Early Physical Therapy Group - Later Physical Therapy Group) in change per day per day (the interaction effect of the mixed model analysis).|Analysis for EcFi condition||0.002|-0.007|0.240
72332009|NCT03479541|144188756|OTHER|Linear mixed effect model containing fixed effects for group (earlier or later), time since injury, and group x time since injury interaction with random intercepts, covariates (age, gender, and Initial SCAT symptom severity total score), and inverse probability weights. Later Physical Therapy Group served as the reference.|Slope|-0.005||||0.003|TWO_SIDED|95.0|-0.009|-0.002||a priori threshold p \< 0.05|Mixed Models Analysis||The slope estimate is the group difference (Early Physical Therapy Group - Later Physical Therapy Group) in change per day per day (the interaction effect of the mixed model analysis).|Analysis for EcFo condition||-0.002|-0.009|0.003
72332010|NCT03479541|144188757|OTHER|Linear mixed effect model containing fixed effects for group (earlier or later), time since injury, and group x time since injury interaction with random intercepts, covariates (age, gender, and Initial SCAT symptom severity total score), and inverse probability weights. Later Physical Therapy Group served as the reference.|Slope|-0.0112||||0.042|TWO_SIDED|95.0|-0.0219|-0.0004||a priori threshold p \< 0.05|Mixed Models Analysis||The slope estimate is the group difference (Early Physical Therapy Group - Later Physical Therapy Group) in change per day per day (the interaction effect of the mixed model analysis).|Analysis for Single Task Average Lap Time||-0.0004|-0.0219|0.042
72332011|NCT03479541|144188757|OTHER|Linear mixed effect model containing fixed effects for group (earlier or later), time since injury, and group x time since injury interaction with random intercepts, covariates (age, gender, and Initial SCAT symptom severity total score), and inverse probability weights. Later Physical Therapy Group served as the reference.|Slope|-0.0111||||0.0311|TWO_SIDED|95.0|-0.0211|-0.001||a priori threshold p \< 0.05|Mixed Models Analysis||The slope estimate is the group difference (Early Physical Therapy Group - Later Physical Therapy Group) in change per day per day (the interaction effect of the mixed model analysis).|Analysis for Auditory Stroop Average Lap Time||-0.0010|-0.0211|0.0311
72332012|NCT03479541|144188758|OTHER|Linear mixed effect model containing fixed effects for group (earlier or later), time since injury, and group x time since injury interaction with random intercepts, covariates (age, gender, and Initial SCAT symptom severity total score), and inverse probability weights. Later Physical Therapy Group served as the reference.|Slope|0.00029||||0.3226|TWO_SIDED|95.0|-0.0003|0.00087||a priori threshold p \< 0.05|Mixed Models Analysis||The slope estimate is the group difference (Early Physical Therapy Group - Later Physical Therapy Group) in change per day per day (the interaction effect of the mixed model analysis).|Analysis for Single Task Gait Speed||0.00087|-0.0003|0.3226
72422719|NCT03502616|144356417|SUPERIORITY||LS mean difference|3.66|STANDARD_ERROR_OF_MEAN|1.541||0.0182|TWO_SIDED|95.0|0.63|6.7|||Mixed Models Analysis|||Week 32: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||6.70|0.63|0.0182
72332013|NCT03479541|144188758|OTHER|Linear mixed effect model containing fixed effects for group (earlier or later), time since injury, and group x time since injury interaction with random intercepts, covariates (age, gender, and Initial SCAT symptom severity total score), and inverse probability weights. Later Physical Therapy Group served as the reference.|Slope|0.00035||||0.2218|TWO_SIDED|95.0|-0.0002|0.0009||a priori threshold p \< 0.05|Mixed Models Analysis|||Analysis for Auditory Stroop Gait Speed|The slope estimate is the group difference (Early Physical Therapy Group - Later Physical Therapy Group) in change per day per day (the interaction effect of the mixed model analysis).|0.00090|-0.0002|0.2218
72422720|NCT03502616|144356417|SUPERIORITY||LS mean difference|3.85|STANDARD_ERROR_OF_MEAN|1.545||0.0133|TWO_SIDED|95.0|0.81|6.9|||Mixed Models Analysis|||Week 40: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||6.90|0.81|0.0133
72422721|NCT03502616|144356417|SUPERIORITY||LS mean difference|3.49|STANDARD_ERROR_OF_MEAN|1.541||0.0245|TWO_SIDED|95.0|0.45|6.52|||Mixed Models Analysis|||Week 48: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||6.52|0.45|0.0245
72422722|NCT03502616|144356418|SUPERIORITY||LS mean difference|0.81|STANDARD_ERROR_OF_MEAN|0.257||0.0018|TWO_SIDED|95.0|0.3|1.32|||Mixed Models Analysis|||Week 2: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||1.32|0.30|0.0018
72422723|NCT03502616|144356418|SUPERIORITY||LS mean difference|1.06|STANDARD_ERROR_OF_MEAN|0.301||0.0005|TWO_SIDED|95.0|0.47|1.65|||Mixed Models Analysis|||Week 4: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||1.65|0.47|0.0005
72332014|NCT03479541|144188759|OTHER|Linear mixed effect model containing fixed effects for group (earlier or later), time since injury, and group x time since injury interaction with random intercepts, covariates (age, gender, and Initial SCAT symptom severity total score), and inverse probability weights. Later Physical Therapy Group served as the reference.|Slope|0.161||||0.0742|TWO_SIDED|95.0|-0.0159|0.338||a priori threshold p \< 0.05|Mixed Models Analysis||The slope estimate is the group difference (Early Physical Therapy Group - Later Physical Therapy Group) in change per day per day (the interaction effect of the mixed model analysis).|Analysis for Single Task 180 Degree Turn Velocity||0.338|-0.0159|0.0742
72332015|NCT03479541|144188759|OTHER|Linear mixed effect model containing fixed effects for group (earlier or later), time since injury, and group x time since injury interaction with random intercepts, covariates (age, gender, and Initial SCAT symptom severity total score), and inverse probability weights. Later Physical Therapy Group served as the reference.|Slope|0.217||||0.0121|TWO_SIDED|95.0|0.048|0.385||a priori threshold p \< 0.05|Mixed Models Analysis||The slope estimate is the group difference (Early Physical Therapy Group - Later Physical Therapy Group) in change per day per day (the interaction effect of the mixed model analysis).|Analysis for Auditory Stroop 180 Degree Turn Velocity||0.385|0.0480|0.0121
72332016|NCT03479541|144188760|OTHER|Linear mixed effect model containing fixed effects for group (earlier or later), time since injury, and group x time since injury interaction with random intercepts, covariates (age, gender, and Initial SCAT symptom severity total score), and inverse probability weights. Later Physical Therapy Group served as the reference.|Slope|0.00063||||0.8906|TWO_SIDED|95.0|-0.0084|0.00961||a priori threshold p \< 0.05|Mixed Models Analysis||The slope estimate is the group difference (Early Physical Therapy Group - Later Physical Therapy Group) in change per day per day (the interaction effect of the mixed model analysis).|Analysis for Single Task Percentage of Double Support Time of Gait Cycle||0.00961|-0.0084|0.8906
72368980|NCT01600170|144247903|SUPERIORITY|||||||0.62||||||The threshold of statistical significance was p = 0.05|Mixed Models Analysis|||Analysis focused on a comparison of change in response over 12 wks for each treatment under a 2x2 crossover design. Mixed effects model was used to estimate within subject treatment differences, trends over time \& at each wk(0,2,6,12). Log-transformations were applied to meet normality assumption \& models adjusted for period \& sequence effects. Secondary outcome analyses used p\<0.05 for statistical significance after adjustment for multiple comparisons.||||0.62
72332017|NCT03479541|144188760|OTHER|Linear mixed effect model containing fixed effects for group (earlier or later), time since injury, and group x time since injury interaction with random intercepts, covariates (age, gender, and Initial SCAT symptom severity total score), and inverse probability weights. Later Physical Therapy Group served as the reference.|Slope|-0.001||||0.8447|TWO_SIDED|95.0|-0.0107|0.00874||a priori threshold p \< 0.05|Mixed Models Analysis||The slope estimate is the group difference (Early Physical Therapy Group - Later Physical Therapy Group) in change per day per day (the interaction effect of the mixed model analysis).|Analysis for Auditory Stroop Percentage of Double Support Time of Gait Cycle||0.00874|-0.0107|0.8447
72422724|NCT03502616|144356418|SUPERIORITY||LS mean difference|1.19|STANDARD_ERROR_OF_MEAN|0.305||0.0001|TWO_SIDED|95.0|0.59|1.79|||Mixed Models Analysis|||Week 8: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||1.79|0.59|0.0001
72332018|NCT03479541|144188761|OTHER|Linear mixed effect model containing fixed effects for group (earlier or later), time since injury, and group x time since injury interaction with random intercepts, covariates (age, gender, and Initial SCAT symptom severity total score), and inverse probability weights. Later Physical Therapy Group served as the reference.|Slope|-0.0003||||0.013|TWO_SIDED|95.0|-0.0005|-0.0001||a priori threshold p \< 0.05|Mixed Models Analysis||The slope estimate is the group difference (Early Physical Therapy Group - Later Physical Therapy Group) in change per day per day (the interaction effect of the mixed model analysis).|Analysis for CSMI Outcome - Visual Weight (VS/EO)||-0.0001|-0.0005|0.013
72332019|NCT03479541|144188761|OTHER|Linear mixed effect model containing fixed effects for group (earlier or later), time since injury, and group x time since injury interaction with random intercepts, covariates (age, gender, and Initial SCAT symptom severity total score), and inverse probability weights. Later Physical Therapy Group served as the reference.|Slope|0.0001||||0.78|TWO_SIDED|95.0|-0.0003|0.0004||a priori threshold p \< 0.05|Mixed Models Analysis||The slope estimate is the group difference (Early Physical Therapy Group - Later Physical Therapy Group) in change per day per day (the interaction effect of the mixed model analysis).|Analysis for CSMI Outcome - Vestibular Weight (SS+VS/EO)||0.0004|-0.0003|0.780
72332020|NCT03479541|144188762|OTHER|Linear mixed effect model containing fixed effects for group (earlier or later), time since injury, and group x time since injury interaction with random intercepts, covariates (age, gender, and Initial SCAT symptom severity total score), and inverse probability weights. Later Physical Therapy Group served as the reference.|Slope|-0.235|||<|0.001|TWO_SIDED|95.0|-0.361|-0.11||a priori threshold p \< 0.05|Mixed Models Analysis||The slope estimate is the group difference (Early Physical Therapy Group - Later Physical Therapy Group) in change per day per day (the interaction effect of the mixed model analysis).|Analysis for CSMI Outcome - Time Delay (VS/EO)||-0.110|-0.361|<0.001
72332021|NCT03479541|144188762|OTHER|Linear mixed effect model containing fixed effects for group (earlier or later), time since injury, and group x time since injury interaction with random intercepts, covariates (age, gender, and Initial SCAT symptom severity total score), and inverse probability weights. Later Physical Therapy Group served as the reference.|Slope|-0.142||||0.002|TWO_SIDED|95.0|-0.233|-0.052||a priori threshold p \< 0.05|Mixed Models Analysis||The slope estimate is the group difference (Early Physical Therapy Group - Later Physical Therapy Group) in change per day per day (the interaction effect of the mixed model analysis).|Analysis for CSMI Outcome - Time Delay (SS+VS/EO)||-0.052|-0.233|0.002
72332022|NCT03479541|144188763|OTHER|Linear mixed effect model containing fixed effects for group (earlier or later), time since injury, and group x time since injury interaction with random intercepts, covariates (age, gender, and Initial SCAT symptom severity total score), and inverse probability weights. Later Physical Therapy Group served as the reference.|Slope|0.0003||||0.237|TWO_SIDED|95.0|-0.0002|0.0007||a priori threshold p \< 0.05|Mixed Models Analysis||The slope estimate is the group difference (Early Physical Therapy Group - Later Physical Therapy Group) in change per day per day (the interaction effect of the mixed model analysis).|Analysis for CSMI Outcome - Normalized Stiffness (VS/EO)||0.0007|-0.0002|0.237
72332023|NCT03479541|144188763|OTHER|Linear mixed effect model containing fixed effects for group (earlier or later), time since injury, and group x time since injury interaction with random intercepts, covariates (age, gender, and Initial SCAT symptom severity total score), and inverse probability weights. Later Physical Therapy Group served as the reference.|Slope|0.0008||||0.002|TWO_SIDED|95.0|0.0003|0.001||a priori threshold p \< 0.05|Mixed Models Analysis||The slope estimate is the group difference (Early Physical Therapy Group - Later Physical Therapy Group) in change per day per day (the interaction effect of the mixed model analysis).|Analysis for CSMI Outcome - Normalized Stiffness (SS+VS/EO)||0.001|0.0003|0.002
72332024|NCT03479541|144188764|OTHER|Linear mixed effect model containing fixed effects for group (earlier or later), time since injury, and group x time since injury interaction with random intercepts, covariates (age, gender, and Initial SCAT symptom severity total score), and inverse probability weights. Later Physical Therapy Group served as the reference.|Slope|0.0001||||0.247|TWO_SIDED|95.0|-0.0001|0.0004||a priori threshold p \< 0.05|Mixed Models Analysis||The slope estimate is the group difference (Early Physical Therapy Group - Later Physical Therapy Group) in change per day per day (the interaction effect of the mixed model analysis).|Analysis for CSMI Outcome - Normalized Damping (VS/EO)||0.0004|-0.0001|0.247
72368981|NCT01600170|144247904|SUPERIORITY|||||||0.99||||||The threshold of statistical significance was p = 0.05|Mixed Models Analysis|||Analysis focused on a comparison of change in response over 12 wks for each treatment under a 2x2 crossover design. Mixed effects model was used to estimate within subject treatment differences, trends over time \& at each wk(0,2,6,12). Log-transformations were applied to meet normality assumption \& models adjusted for period \& sequence effects. Secondary outcome analyses used p\<0.05 for statistical significance after adjustment for multiple comparisons.||||0.99
72368982|NCT02873702|144247949|NON_INFERIORITY|Non-inferiority to lansoprazole if the lower bound of confidence interval (CI) for the treatment difference is greater than -10%.|Difference in Percentage|-2.65|||||TWO_SIDED|95.0|-26.59|21.3||||||Healing Period: Dexlansoprazole 60 mg versus Healing Period: Lansoprazole 30 mg||21.30|-26.59|
72332025|NCT03479541|144188764|OTHER|Linear mixed effect model containing fixed effects for group (earlier or later), time since injury, and group x time since injury interaction with random intercepts, covariates (age, gender, and Initial SCAT symptom severity total score), and inverse probability weights. Later Physical Therapy Group served as the reference.|Slope|0.0004||||0.008|TWO_SIDED|95.0|0.0001|0.0007||a priori threshold p \< 0.05|Mixed Models Analysis||The slope estimate is the group difference (Early Physical Therapy Group - Later Physical Therapy Group) in change per day per day (the interaction effect of the mixed model analysis).|Analysis for CSMI Outcome - Normalized Damping (SS+VSEO)||0.0007|0.0001|0.008
72368983|NCT01039376|144247957|SUPERIORITY||Hazard Ratio (HR)|0.55|||<|0.0001|TWO_SIDED|95.0|0.43|0.7|||Stratified log rank test||Hazard ratios were obtained using the Pike estimator. A hazard ratio of \<1 indicated a lower risk with ofatumumab maintenance compared with no further treatment.|||0.70|0.43|<0.0001
72368984|NCT01039376|144247958|SUPERIORITY||Hazard Ratio (HR)|0.54|||<|0.0001|TWO_SIDED|95.0|0.42|0.68|||Stratified log rank test||Hazard ratios were obtained using the Pike estimator. A hazard ratio of \<1 indicated a lower risk with ofatumumab maintenance compared with no further treatment.|||0.68|0.42|<0.0001
72368985|NCT01039376|144247959|SUPERIORITY||Hazard Ratio (HR)|0.93||||0.6046|TWO_SIDED|95.0|0.69|1.25|||Stratified log rank test||Hazard ratios were obtained using the Pike estimator. A hazard ratio of \<1 indicated a lower risk with ofatumumab maintenance compared with no further treatment.|||1.25|0.69|0.6046
72368986|NCT01039376|144247961|SUPERIORITY||Hazard Ratio (HR)|0.77||||0.0178|TWO_SIDED|95.0|0.62|0.96|||Stratified log rank test||Hazard ratios were obtained using the Pike estimator. A hazard ratio of \<1 indicated a lower risk with ofatumumab maintenance compared with no further treatment.|||0.96|0.62|0.0178
72368987|NCT01039376|144247962|SUPERIORITY||Hazard Ratio (HR)|0.74||||0.3136|TWO_SIDED|95.0|0.42|1.32|||log rank test||Hazard ratios were obtained using the Pike estimator. A hazard ratio of \<1 indicated a lower risk with ofatumumab maintenance compared with no further treatment.|||1.32|0.42|0.3136
72368988|NCT01039376|144247963|SUPERIORITY||Hazard Ratio (HR)|0.59||||0.1603|TWO_SIDED|95.0|0.29|1.19|||log rank test||Hazard ratios were obtained using the Pike estimator. A hazard ratio of \<1 indicated a lower risk with ofatumumab maintenance compared with no further treatment.|||1.19|0.29|0.1603
72332026|NCT03479541|144188765|OTHER|Linear mixed effect model containing fixed effects for group (earlier or later), time since injury, and group x time since injury interaction with random intercepts, covariates (age, gender, and Initial SCAT symptom severity total score), and inverse probability weights. Later Physical Therapy Group served as the reference.|Slope|-0.004||||0.003|TWO_SIDED|95.0|-0.006|-0.001||a priori threshold p \< 0.05|Mixed Models Analysis||The slope estimate is the group difference (Early Physical Therapy Group - Later Physical Therapy Group) in change per day per day (the interaction effect of the mixed model analysis).|Analysis for CSMI Outcome - Evoked Center of Mass (CoM) Sway (VS/EO)||-0.001|-0.006|0.003
72368989|NCT01039376|144247964|SUPERIORITY||Mean Difference (Final Values)|-2.19||||0.0199|TWO_SIDED|95.0|-4.04|-0.35||The analysis is adjusted for BL score, actual strata, age group, BL ECOG performance status and Binet stage at Screening using mixed-model (Proc Mixed) repeated with intercept, BL score by time and treatment by time interaction.|Repeated measures analysis of covariance||Disease Effects Scale|||-0.35|-4.04|0.0199
72368990|NCT01039376|144247964|SUPERIORITY||Mean Difference (Final Values)|-3.79||||0.0085|TWO_SIDED|95.0|-6.61|-0.97||The analysis is adjusted for BL score, actual strata, age group, BL ECOG performance status and Binet stage at Screening using mixed-model (Proc Mixed) repeated with intercept, BL score by time and treatment by time interaction.|Repeated measures analysis of covariance||Fatigue Scale|||-0.97|-6.61|0.0085
72422725|NCT03502616|144356418|SUPERIORITY||LS mean difference|1.63|STANDARD_ERROR_OF_MEAN|0.274|<|0.0001|TWO_SIDED|95.0|1.09|2.17|||Mixed Models Analysis|||Week 12: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||2.17|1.09|<0.0001
72332027|NCT03479541|144188765|OTHER|Linear mixed effect model containing fixed effects for group (earlier or later), time since injury, and group x time since injury interaction with random intercepts, covariates (age, gender, and Initial SCAT symptom severity total score), and inverse probability weights. Later Physical Therapy Group served as the reference.|Slope|-0.001||||0.004|TWO_SIDED|95.0|-0.003|-0.0005||a priori threshold p \< 0.05|Mixed Models Analysis||The slope estimate is the group difference (Early Physical Therapy Group - Later Physical Therapy Group) in change per day per day (the interaction effect of the mixed model analysis).|Analysis for CSMI Outcome - Evoked CoM Sway (SS+VS/EO)||-0.0005|-0.003|0.004
72368991|NCT01039376|144247964|SUPERIORITY||Mean Difference (Final Values)|-3.58||||0.0642|TWO_SIDED|95.0|-7.37|0.21||The analysis is adjusted for BL score, actual strata, age group, BL ECOG performance status and Binet stage at Screening using mixed-model (Proc Mixed) repeated with intercept, BL score by time and treatment by time interaction.|Repeated measures analysis of covariance||Future Health Scale|||0.21|-7.37|0.0642
72332028|NCT03479541|144188766|OTHER|Linear mixed effect model containing fixed effects for group (earlier or later), time since injury, and group x time since injury interaction with random intercepts, covariates (age, gender, and Initial SCAT symptom severity total score), and inverse probability weights. Later Physical Therapy Group served as the reference.|Slope|-0.004||||0.031|TWO_SIDED|95.0|-0.007|-0.0003||a priori threshold p \< 0.05|Mixed Models Analysis||The slope estimate is the group difference (Early Physical Therapy Group - Later Physical Therapy Group) in change per day per day (the interaction effect of the mixed model analysis).|Analysis for CSMI Outcome - Internal Sensory Noise (VS/EO)||-0.0003|-0.007|0.031
72422726|NCT03502616|144356418|SUPERIORITY||LS mean difference|1.87|STANDARD_ERROR_OF_MEAN|0.344|<|0.0001|TWO_SIDED|95.0|1.2|2.55|||Mixed Models Analysis|||Week 16: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||2.55|1.20|<0.0001
72368992|NCT01039376|144247964|SUPERIORITY||Mean Difference (Final Values)|0.52||||0.6398|TWO_SIDED|95.0|-1.67|2.72||The analysis is adjusted for BL score, actual strata, age group, BL ECOG performance status and Binet stage at Screening using mixed-model (Proc Mixed) repeated with intercept, BL score by time and treatment by time interaction.|Repeated measures analysis of covariance||Infection Scale|||2.72|-1.67|0.6398
72332029|NCT03479541|144188766|OTHER|Linear mixed effect model containing fixed effects for group (earlier or later), time since injury, and group x time since injury interaction with random intercepts, covariates (age, gender, and Initial SCAT symptom severity total score), and inverse probability weights. Later Physical Therapy Group served as the reference.|Slope|-0.003||||0.003|TWO_SIDED|95.0|-0.005|-0.0003||a priori threshold p \< 0.05|Mixed Models Analysis||The slope estimate is the group difference (Early Physical Therapy Group - Later Physical Therapy Group) in change per day per day (the interaction effect of the mixed model analysis).|Analysis for CSMI Outcome - Internal Sensory Noise (SS+VS/EO)||-0.0003|-0.005|0.003
72332030|NCT03479541|144188767|OTHER|Linear mixed effect model containing fixed effects for group (earlier or later), time since injury, and group x time since injury interaction with random intercepts, covariates (age and gender), and inverse probability weights. Later Physical Therapy Group served as the reference.|Slope|-0.0321||||0.3221|TWO_SIDED|95.0|-0.0957|0.0315||a priori threshold p \< 0.05|Mixed Models Analysis||The slope estimate is the group difference (Early Physical Therapy Group - Later Physical Therapy Group) in change per day per day (the interaction effect of the mixed model analysis).|||0.0315|-0.0957|0.3221
72332031|NCT03479541|144188768|OTHER|Linear mixed effect model containing fixed effects for group (earlier or later), time since injury, and group x time since injury interaction with random intercepts, covariates (age, gender, and Initial SCAT symptom severity total score), and inverse probability weights. Later Physical Therapy Group served as the reference.|Slope|-0.0136||||0.336|TWO_SIDED|95.0|-0.0413|0.0142||a priori threshold p \< 0.05|Mixed Models Analysis||The slope estimate is the group difference (Early Physical Therapy Group - Later Physical Therapy Group) in change per day per day (the interaction effect of the mixed model analysis).|||0.0142|-0.0413|0.336
72332032|NCT03479541|144188769|OTHER|Linear mixed effect model containing fixed effects for group (earlier or later), time since injury, and group x time since injury interaction with random intercepts, covariates (age, gender, and Initial SCAT symptom severity total score), and inverse probability weights. Later Physical Therapy Group served as the reference.|Slope|-0.0406||||0.033|TWO_SIDED|95.0|-0.0779|-0.0032||a priori threshold p \< 0.05|Mixed Models Analysis||The slope estimate is the group difference (Early Physical Therapy Group - Later Physical Therapy Group) in change per day per day (the interaction effect of the mixed model analysis).|||-0.0032|-0.0779|0.033
72332033|NCT00661726|144188770|SUPERIORITY_OR_OTHER||||||<|0.01||95.0|||||Regression, Linear|||Linear regression after adjusting for time duration was used to test the mean difference between baseline and follow-up values.||||<0.01
72332034|NCT00661726|144188772|SUPERIORITY_OR_OTHER|||||||0.045||95.0|||||Regression, Linear|||Linear regression after adjusting for time duration was used to test the mean difference between baseline and follow-up values.||||0.045
72332035|NCT00661726|144188773|SUPERIORITY_OR_OTHER|||||||0.083||95.0|||||Regression, Linear|||Linear regression after adjusting for time duration was used to test the mean difference between baseline and follow-up values.||||0.083
72332036|NCT00661726|144188774|SUPERIORITY_OR_OTHER|||||||0.039||95.0|||||Regression, Linear|||Linear regression after adjusting for time duration was used to test the mean difference between baseline and follow-up values.||||0.039
72332037|NCT00661726|144188775|SUPERIORITY_OR_OTHER|||||||0.18||95.0|||||Regression, Linear|||Linear regression after adjusting for time duration was used to test the mean difference between baseline and follow-up values.||||0.18
72332038|NCT00661726|144188776|SUPERIORITY_OR_OTHER||||||<|0.01||95.0|||||Regression, Linear|||Linear regression after adjusting for time duration was used to test the mean difference between baseline and follow-up values.||||<0.01
72332039|NCT00661726|144188777|SUPERIORITY_OR_OTHER|||||||0.069||95.0|||||Regression, Linear|||Linear regression after adjusting for time duration was used to test the mean difference between baseline and follow-up values.||||0.069
72332040|NCT00661726|144188778|SUPERIORITY_OR_OTHER|||||||0.18||95.0|||||Regression, Linear|||Linear regression after adjusting for time duration was used to test the mean difference between baseline and follow-up values.||||0.18
72332041|NCT00661726|144188779|SUPERIORITY_OR_OTHER|||||||0.022||95.0|||||Regression, Linear|||Linear regression after adjusting for time duration was used to test the mean difference between baseline and follow-up values.||||0.022
72332042|NCT00661726|144188780|SUPERIORITY_OR_OTHER|||||||0.11||95.0|||||Regression, Linear|||Linear regression after adjusting for time duration was used to test the mean difference between baseline and follow-up values.||||0.11
72332043|NCT00661726|144188781|SUPERIORITY_OR_OTHER||||||<|0.01||95.0|||||Regression, Linear|||Linear regression after adjusting for time duration was used to test the mean difference between baseline and follow-up values.||||<0.01
72332044|NCT00107900|144188783|SUPERIORITY_OR_OTHER|||||||0.238|TWO_SIDED||||||Fisher Exact|||||||0.238
72332045|NCT03088930|144188795|OTHER||Summary statistics|0.0|||||TWO_SIDED|||||||||Three subjects enrolled. No statistical analysis completed due to low accrual.|Three subjects enrolled. No statistical analysis completed due to low accrual.|||
72332046|NCT00066703|144188807|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.717||||0.0002|TWO_SIDED|95.0|0.602|0.855|||Log Rank||T+OFS is the reference group in the estimation of the hazard ratio.|||0.855|0.602|.0002
72332047|NCT00066703|144188808|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.664|||<|0.0001|TWO_SIDED|95.0|0.548|0.804|||Log Rank||T+OFS is the reference group for the estimation of the hazard ratio.|||.804|.548|<.0001
72332048|NCT00066703|144188809|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.777||||0.02|TWO_SIDED|95.0|0.624|0.967|||Log Rank||T+OFS was the reference group in the estimation of the hazard ratio|||0.967|0.624|0.02
72332049|NCT00066703|144188810|SUPERIORITY||Hazard Ratio (HR)|0.98||||0.84|TWO_SIDED|95.0|0.79|1.22|||Log Rank||T+OFS was the reference group in the estimation of the hazard ratio|||1.22|0.79|0.84
72332050|NCT01696968|144188811|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.99|||||TWO_SIDED|95.0|0.91|1.07|||Poisson regression|||||1.07|0.91|
72332051|NCT01696968|144188813|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.98|||||TWO_SIDED|95.0|0.95|1.0|||Poisson regression|||||1.00|0.95|
72332052|NCT01696968|144188815|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.05|||||TWO_SIDED|95.0|0.98|1.12|||Poisson regression|||||1.12|0.98|
72332053|NCT01696968|144188819|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.99|||||TWO_SIDED|95.0|0.91|1.07|||Poisson regression|||||1.07|0.91|
72332054|NCT01716039|144188826|OTHER|Comparing the change in the modified Baron score from baseline to week 18 between the treatment groups||||||0.758|||||||Wilcoxon (Mann-Whitney)|||||||0.758
72332055|NCT01716039|144188826|OTHER|||||||1|||||||Wilcoxon (Mann-Whitney)|||||||1.00
72332056|NCT01716039|144188827|OTHER|||||||0.908||||||p-value for the overall treatment difference is based on an analysis of covariance adjusting for baseline UCEIS|ANCOVA|||||||0.908
72332057|NCT04925076|144188835|SUPERIORITY|||||||0.92|||||||ANOVA|F(1,108)=.01||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on pain threshold. Here we report the results of the analysis of the condition X family history X sex interaction.||||.92
72332058|NCT04925076|144188835|SUPERIORITY|||||||0.92|||||||ANOVA|F(1,108) = .01||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on pain threshold. Here we report the results of the analysis of the condition X sex interaction.||||.92
72332059|NCT04925076|144188835|SUPERIORITY|||||||0.61|||||||Chi-squared|F(1,108) = 0.27||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on pain threshold. Here we report the results of the analysis of the condition X family history interaction.||||.61
72332060|NCT04925076|144188835|SUPERIORITY|||||||0.01|||||||ANOVA|F(1,108) = 6.75||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on pain threshold. Here we report the results of the analysis of the family history X sex interaction.||||.01
72332061|NCT04925076|144188835|SUPERIORITY|||||||0.05|||||||ANOVA|F(1,108) = 3.83||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on pain threshold. Here we report the results of the analysis of the main effect of condition.||||.05
72332062|NCT04925076|144188835|SUPERIORITY|||||||0.003|||||||ANOVA|F(1,108) = 9.53||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on pain threshold. Here we report the results of the analysis of the main effect of family history.||||.003
72332063|NCT04925076|144188835|SUPERIORITY|||||||0.12|||||||ANOVA|F(1,108) = 2.41||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on pain threshold. Here we report the results of the analysis of the main effect of sex.||||.12
72332064|NCT04925076|144188836|SUPERIORITY|||||||0.38|||||||ANOVA|F(1,107) = 0.78||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on pain tolerance. Here we report the results of the analysis of the condition X family history X sex interaction.||||.38
72332065|NCT04925076|144188836|SUPERIORITY|||||||0.27|||||||ANOVA|F(1,107) = 0.27||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on pain tolerance. Here we report the results of the analysis of the condition X sex interaction.||||.27
72332066|NCT04925076|144188836|SUPERIORITY|||||||0.7|||||||ANOVA|F(1,107) = 0.15||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on pain tolerance. Here we report the results of the analysis of the condition X family history interaction.||||.70
72332067|NCT04925076|144188836|SUPERIORITY|||||||0.05|||||||ANOVA|F(1,107) = 3.87||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on pain tolerance. Here we report the results of the analysis of the family history X sex interaction.||||.05
72332068|NCT04925076|144188836|SUPERIORITY|||||||0.03|||||||ANOVA|F(1,107) = 5.18||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on pain tolerance. Here we report the results of the analysis of the main effect of condition.||||.03
72332069|NCT04925076|144188836|SUPERIORITY|||||||0.14|||||||ANOVA|F(1,107) = 2.24||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on pain tolerance. Here we report the results of the analysis of the main effect of family history.||||.14
72332070|NCT04925076|144188836|SUPERIORITY||||||<|0.001|||||||ANOVA|F(1,107) = 17.25||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on pain tolerance. Here we report the results of the analysis of the main effect of sex.||||<.001
72332071|NCT04925076|144188837|SUPERIORITY|||||||0.83|||||||ANOVA|F(1,107) = 0.05||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on pain intensity. Here we report the results of the analysis of the condition X family history X sex interaction.||||.83
72332072|NCT04925076|144188837|SUPERIORITY|||||||0.12|||||||ANOVA|F(1,107) = 2.43||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on pain intensity. Here we report the results of the analysis of the condition X sex interaction.||||.12
72332073|NCT04925076|144188837|SUPERIORITY|||||||0.25|||||||ANOVA|F(1,107) = 1.36||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on pain intensity. Here we report the results of the analysis of the condition X family history interaction.||||.25
72332074|NCT04925076|144188837|SUPERIORITY|||||||0.58|||||||ANOVA|F(1,107) = 0.31||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on pain intensity. Here we report the results of the analysis of the family history X sex interaction.||||.58
72332075|NCT04925076|144188837|SUPERIORITY|||||||0.9|||||||ANOVA|F(1,107) = 0.02||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on pain intensity. Here we report the results of the analysis of the main effect of condition.||||.90
72422727|NCT03502616|144356418|SUPERIORITY||LS mean difference|0.95|STANDARD_ERROR_OF_MEAN|0.353||0.0075|TWO_SIDED|95.0|0.26|1.65|||Mixed Models Analysis|||Week 24: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||1.65|0.26|0.0075
72422728|NCT03502616|144356418|SUPERIORITY||LS mean difference|0.58|STANDARD_ERROR_OF_MEAN|0.403||0.1489|TWO_SIDED|95.0|-0.21|1.38|||Mixed Models Analysis|||Week 32: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||1.38|-0.21|0.1489
72422729|NCT03502616|144356418|SUPERIORITY||LS mean difference|0.78|STANDARD_ERROR_OF_MEAN|0.417||0.0609|TWO_SIDED|95.0|-0.04|1.61|||Mixed Models Analysis|||Week 40: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||1.61|-0.04|0.0609
72422730|NCT03502616|144356418|SUPERIORITY||LS mean difference|0.3|STANDARD_ERROR_OF_MEAN|0.429||0.4822|TWO_SIDED|95.0|-0.54|1.15|||Mixed Models Analysis|||Week 48: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||1.15|-0.54|0.4822
72332076|NCT04925076|144188837|SUPERIORITY|||||||0.95|||||||ANOVA|F(1,107) = .004||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on pain intensity. Here we report the results of the analysis of the main effect of family history.||||.95
72422731|NCT03502616|144356419|SUPERIORITY||LS mean difference|0.37|STANDARD_ERROR_OF_MEAN|0.131||0.0047|TWO_SIDED|95.0|0.12|0.63|||Mixed Models Analysis|||Week 2: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.63|0.12|0.0047
72332077|NCT04925076|144188837|SUPERIORITY|||||||0.68|||||||ANOVA|F(1,107) = 0.17||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on pain intensity. Here we report the results of the analysis of the main effect of sex.||||.68
72332078|NCT04925076|144188838|SUPERIORITY|||||||0.36|||||||ANOVA|F(1,107) = 0.83||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on pain relief. Here we report the results of the analysis of the condition X family history X sex interaction.||||.36
72332079|NCT04925076|144188838|SUPERIORITY|||||||0.24|||||||ANOVA|F(1,108) = 1.41||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on pain relief. Here we report the results of the analysis of the condition X sex interaction.||||.24
72332080|NCT04925076|144188838|SUPERIORITY|||||||0.6|||||||ANOVA|F(1,108) = 0.28||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on pain relief. Here we report the results of the analysis of the condition X family history interaction.||||.60
72332081|NCT04925076|144188838|SUPERIORITY|||||||0.99|||||||ANOVA|F(1,108) = 0.00||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on pain relief. Here we report the results of the analysis of the family history X sex interaction.||||.99
72332082|NCT04925076|144188838|SUPERIORITY||||||<|0.001|||||||ANOVA|F(1,108) = 139.63||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on pain relief. Here we report the results of the analysis of the main effect of condition.||||<.001
72332083|NCT04925076|144188838|SUPERIORITY|||||||0.84|||||||ANOVA|F(1,108) = 0.04||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on pain relief. Here we report the results of the analysis of the main effect of family history.||||.84
72422732|NCT03502616|144356419|SUPERIORITY||LS mean difference|0.52|STANDARD_ERROR_OF_MEAN|0.131||0.0001|TWO_SIDED|95.0|0.26|0.77|||Mixed Models Analysis|||Week 4: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.77|0.26|0.0001
72332084|NCT04925076|144188838|SUPERIORITY|||||||0.59|||||||ANOVA|F(1,108) = 0.30||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on pain relief. Here we report the results of the analysis of the main effect of sex.||||.59
72332085|NCT04925076|144188839|SUPERIORITY|||||||0.66|||||||ANOVA|F(1,93)=0.19||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on dorsolateral prefrontal cortex activation. Here we report the results of the analysis of the condition X family history X sex interaction.||||.66
72332086|NCT04925076|144188839|SUPERIORITY|||||||0.41|||||||ANOVA|F(1,93)=0.69||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on dorsolateral prefrontal cortex activation. Here we report the results of the analysis of the condition X sex interaction.||||.41
72332087|NCT04925076|144188839|SUPERIORITY|||||||0.39|||||||ANOVA|F(1,93)=0.74||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on dorsolateral prefrontal cortex activation. Here we report the results of the analysis of the condition X family history interaction.||||.39
72332088|NCT04925076|144188839|SUPERIORITY|||||||0.22|||||||ANOVA|F(1,93)=1.54||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on dorsolateral prefrontal cortex activation. Here we report the results of the analysis of the family history X sex interaction.||||.22
72332089|NCT04925076|144188839|SUPERIORITY|||||||0.06|||||||ANOVA|F(1,93)=3.64||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on dorsolateral prefrontal cortex activation. Here we report the results of the analysis of the main effect of condition.||||.06
72422733|NCT03502616|144356419|SUPERIORITY||LS mean difference|0.49|STANDARD_ERROR_OF_MEAN|0.148||0.0012|TWO_SIDED|95.0|0.19|0.78|||Mixed Models Analysis|||Week 8: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.78|0.19|0.0012
72332090|NCT04925076|144188839|SUPERIORITY|||||||0.99|||||||ANOVA|F(1,93)=0.000||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on dorsolateral prefrontal cortex activation. Here we report the results of the analysis of the main effect of family history.||||.99
72332091|NCT04925076|144188839|SUPERIORITY|||||||0.09|||||||ANOVA|F(1,93)=2.88||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on dorsolateral prefrontal cortex activation. Here we report the results of the analysis of the main effect of sex.||||.09
72332092|NCT04925076|144188840|SUPERIORITY|||||||0.55|||||||ANOVA|F(1,93)=0.36||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on hypothalamus activation. Here we report the results of the analysis of the condition X family history X sex interaction.||||.55
72332093|NCT04925076|144188840|SUPERIORITY|||||||0.36|||||||ANOVA|F(1,93)=0.84||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on hypothalamus activation. Here we report the results of the analysis of the condition X sex interaction.||||.36
72332094|NCT04925076|144188840|SUPERIORITY|||||||0.36|||||||ANOVA|F(1,93)=0.84||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on hypothalamus activation. Here we report the results of the analysis of the condition X family history interaction.||||.36
72332095|NCT04925076|144188840|SUPERIORITY|||||||0.17|||||||ANOVA|F(1,93)=1.93||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on hypothalamus activation. Here we report the results of the analysis of the family history X sex interaction.||||.17
72332096|NCT04925076|144188840|SUPERIORITY|||||||0.55|||||||ANOVA|F(1,93)=0.36||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on hypothalamus activation. Here we report the results of the analysis of the main effect of condition.||||.55
72422734|NCT03502616|144356419|SUPERIORITY||LS mean difference|0.48|STANDARD_ERROR_OF_MEAN|0.142||0.0008|TWO_SIDED|95.0|0.2|0.76|||Mixed Models Analysis|||Week 12: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.76|0.20|0.0008
72332097|NCT04925076|144188840|SUPERIORITY|||||||0.43|||||||ANOVA|F(1,93)=0.63||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on hypothalamus activation. Here we report the results of the analysis of the main effect of family history.||||.43
72332098|NCT04925076|144188840|SUPERIORITY|||||||0.33|||||||ANOVA|F(1,93)=0.96||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on pain threshold. Here we report the results of the analysis of the main effect of sex.||||.33
72332099|NCT04925076|144188841|SUPERIORITY|||||||0.34|||||||ANOVA|F(1,93)=0.34||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on medial prefrontal cortex activation. Here we report the results of the analysis of the condition X family history X sex interaction.||||.34
72332100|NCT04925076|144188841|SUPERIORITY|||||||0.88|||||||ANOVA|F(1,93)=0.02||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on medial prefrontal cortex activation. Here we report the results of the analysis of the condition X sex interaction.||||.88
72332101|NCT04925076|144188841|SUPERIORITY|||||||0.56|||||||ANOVA|F(1,93)=0.34||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on medial prefrontal cortex activation. Here we report the results of the analysis of the condition X family history interaction.||||.56
72332102|NCT04925076|144188841|SUPERIORITY|||||||0.9|||||||ANOVA|F(1,93)=0.02||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on medial prefrontal cortex activation. Here we report the results of the analysis of the family history X sex interaction.||||.90
72332103|NCT04925076|144188841|SUPERIORITY|||||||0.45|||||||ANOVA|F(1,93)=0.59||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on medial prefrontal cortex activation. Here we report the results of the analysis of the main effect of condition.||||.45
72332104|NCT04925076|144188841|SUPERIORITY|||||||0.85|||||||ANOVA|F(1,93)=0.04||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on medial prefrontal cortex activation. Here we report the results of the analysis of the main effect of family history.||||.85
72332105|NCT04925076|144188841|SUPERIORITY|||||||0.64|||||||ANOVA|F(1,93)=0.22||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on medial prefrontal cortex. Here we report the results of the analysis of the main effect of sex.||||.64
72332106|NCT04925076|144188842|SUPERIORITY|||||||0.3|||||||ANOVA|F(1,93)=1.07||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on nucleus accumbens activation. Here we report the results of the analysis of the condition X family history X sex interaction.||||.30
72332107|NCT04925076|144188842|SUPERIORITY|||||||0.11|||||||ANOVA|F(1,93)=2.62||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on nucleus accumbens activation. Here we report the results of the analysis of the condition X sex interaction.||||.11
72332108|NCT04925076|144188842|SUPERIORITY|||||||0.39|||||||ANOVA|F(1,93)=0.76||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on nucleus accumbens activation. Here we report the results of the analysis of the condition X family history interaction.||||.39
72332109|NCT04925076|144188842|SUPERIORITY|||||||0.89|||||||ANOVA|F(1,93)=0.02||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on nucleus accumbens activation. Here we report the results of the analysis of the family history X sex interaction.||||.89
72332110|NCT04925076|144188842|SUPERIORITY|||||||0.01|||||||ANOVA|F(1,93)=6.72||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on nucleus accumbens activation. Here we report the results of the analysis of the main effect of condition.||||.01
72332111|NCT04925076|144188842|SUPERIORITY|||||||0.08|||||||ANOVA|F(1,93)=3.15||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on nucleus accumbens activation. Here we report the results of the analysis of the main effect of family history.||||.08
72332112|NCT04925076|144188842|SUPERIORITY|||||||0.06|||||||ANOVA|F(1,93)=3.71||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on nucleus accumbens activation. Here we report the results of the analysis of the main effect of sex.||||.06
72332113|NCT04925076|144188843|SUPERIORITY|||||||0.29|||||||ANOVA|F(1,93)=1.14||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on periaqueductal gray activation. Here we report the results of the analysis of the condition X family history X sex interaction.||||.29
72332114|NCT04925076|144188843|SUPERIORITY|||||||0.1|||||||ANOVA|F(1,93)=2.84||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on nucleus accumbens activation. Here we report the results of the analysis of the condition X sex interaction.||||.10
72332115|NCT04925076|144188843|SUPERIORITY|||||||0.49|||||||ANOVA|F(1,93)=0.47||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on periaqueductal gray activation. Here we report the results of the analysis of the condition X family history interaction.||||.49
72332116|NCT04925076|144188843|SUPERIORITY|||||||0.99|||||||ANOVA|F(1,93)=0.000||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on periaqueductal gray activation. Here we report the results of the analysis of the family history X sex interaction.||||.99
72332117|NCT04925076|144188843|SUPERIORITY|||||||0.13|||||||ANOVA|F(1,93)=2.29||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on periaqueductal gray activation. Here we report the results of the analysis of the main effect of condition.||||.13
72332118|NCT04925076|144188843|SUPERIORITY|||||||0.82|||||||ANOVA|F(1,93)=0.05||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on periaqueductal gray activation. Here we report the results of the analysis of the main effect of family history.||||.82
72332119|NCT04925076|144188843|SUPERIORITY|||||||0.02|||||||ANOVA|F(1,93)=6.09||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on periaqueductal gray activation. Here we report the results of the analysis of the main effect of sex.||||0.02
72332120|NCT04925076|144188844|SUPERIORITY|||||||0.32|||||||ANOVA|F(1,93)=1.01||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on anterior cingulate cortex activation. Here we report the results of the analysis of the condition X family history X sex interaction.||||.32
72332121|NCT04925076|144188844|SUPERIORITY|||||||0.99|||||||ANOVA|F(1,93)=0.000||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on anterior cingulate cortex activation. Here we report the results of the analysis of the condition X sex interaction.||||.99
72332122|NCT04925076|144188844|SUPERIORITY|||||||0.83|||||||ANOVA|F(1,93)=0.05||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on anterior cingulate cortex activation. Here we report the results of the analysis of the condition X family history interaction.||||.83
72332123|NCT04925076|144188844|SUPERIORITY|||||||0.75|||||||ANOVA|F(1,93)=0.10||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on anterior cingulate cortex activation. Here we report the results of the analysis of the family history X sex interaction.||||.75
72332124|NCT04925076|144188844|SUPERIORITY|||||||0.62|||||||ANOVA|F(1,93)=0.25||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on anterior cingulate cortex activation. Here we report the results of the analysis of the main effect of condition.||||.62
72332125|NCT04925076|144188844|SUPERIORITY|||||||0.92|||||||ANOVA|F(1,93)=0.01||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on anterior cingulate cortex activation. Here we report the results of the analysis of the main effect of family history.||||.92
72332126|NCT04925076|144188844|SUPERIORITY|||||||0.39|||||||ANOVA|F(1,93)=0.76||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on anterior cingulate cortex activation. Here we report the results of the analysis of the main effect of sex.||||.39
72332127|NCT04925076|144188845|SUPERIORITY|||||||0.5|||||||ANOVA|F(1,93)=0.45||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on amygdala activation. Here we report the results of the analysis of the condition X family history X sex interaction.||||.50
72422735|NCT03502616|144356419|SUPERIORITY||LS mean difference|0.53|STANDARD_ERROR_OF_MEAN|0.147||0.0004|TWO_SIDED|95.0|0.24|0.81|||Mixed Models Analysis|||Week 16: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.81|0.24|0.0004
72332128|NCT04925076|144188845|SUPERIORITY|||||||0.28|||||||ANOVA|F(1,93)=1.20||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on amygdala activation. Here we report the results of the analysis of the condition X sex interaction.||||.28
72332129|NCT04925076|144188845|SUPERIORITY|||||||0.6|||||||ANOVA|F(1,93)=0.28||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on amygdala activation. Here we report the results of the analysis of the condition X family history interaction.||||.60
72332130|NCT04925076|144188845|SUPERIORITY|||||||0.04|||||||ANOVA|F(1,93)=4.48||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on amygdala activation. Here we report the results of the analysis of the family history X sex interaction.||||.04
72332131|NCT04925076|144188845|SUPERIORITY|||||||0.25|||||||ANOVA|F(1,93)=1.37||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on amygdala activation. Here we report the results of the analysis of the main effect of condition.||||.25
72332132|NCT04925076|144188845|SUPERIORITY|||||||0.89|||||||ANOVA|F(1,93)=0.01||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on amygdala activation. Here we report the results of the analysis of the main effect of family history.||||.89
72422736|NCT03502616|144356419|SUPERIORITY||LS mean difference|0.32|STANDARD_ERROR_OF_MEAN|0.188||0.0918|TWO_SIDED|95.0|-0.05|0.69|||Mixed Models Analysis|||Week 24: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.69|-0.05|0.0918
72422737|NCT03502616|144356419|SUPERIORITY||LS mean difference|0.25|STANDARD_ERROR_OF_MEAN|0.179||0.16|TWO_SIDED|95.0|-0.1|0.61|||Mixed Models Analysis|||Week 32: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.61|-0.10|0.1600
72332133|NCT04925076|144188845|SUPERIORITY|||||||0.26|||||||ANOVA|F(1,93)=1.28||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on amygdala activation. Here we report the results of the analysis of the main effect of sex.||||.26
72332134|NCT04925076|144188846|SUPERIORITY|||||||0.76|||||||ANOVA|F(1,93)=0.09||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on hippocampus activation. Here we report the results of the analysis of the condition X family history X sex interaction.||||.76
72422738|NCT03502616|144356419|SUPERIORITY||LS mean difference|0.08|STANDARD_ERROR_OF_MEAN|0.195||0.6776|TWO_SIDED|95.0|-0.3|0.47|||Mixed Models Analysis|||Week 40: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.47|-0.30|0.6776
72332135|NCT04925076|144188846|SUPERIORITY|||||||0.09|||||||ANOVA|F(1,93)=3.00||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on hippocampus activation. Here we report the results of the analysis of the condition X sex interaction.||||.09
72332136|NCT04925076|144188846|SUPERIORITY|||||||0.76|||||||ANOVA|F(1,93)=0.10||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on hippocampus activation. Here we report the results of the analysis of the condition X family history interaction.||||.76
72332137|NCT04925076|144188846|SUPERIORITY|||||||0.77|||||||ANOVA|F(1,93)=0.09||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on hippocampus activation. Here we report the results of the analysis of the family history X sex interaction.||||.77
72332138|NCT04925076|144188846|SUPERIORITY|||||||0.52|||||||ANOVA|F(1,93)=0.41||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on hippocampus activation. Here we report the results of the analysis of the main effect of condition.||||.52
72332139|NCT04925076|144188846|SUPERIORITY|||||||0.93|||||||ANOVA|F(1,93)=0.007||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on pain hippocampus activation. Here we report the results of the analysis of the main effect of family history.||||.93
72332140|NCT04925076|144188846|SUPERIORITY|||||||0.42|||||||ANOVA|F(1,93)=0.64||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on hippocampus activation. Here we report the results of the analysis of the main effect of sex.||||.42
72422739|NCT03502616|144356419|SUPERIORITY||LS mean difference|0.1|STANDARD_ERROR_OF_MEAN|0.18||0.5646|TWO_SIDED|95.0|-0.25|0.46|||Mixed Models Analysis|||Week 48: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.46|-0.25|0.5646
72332141|NCT04925076|144188847|SUPERIORITY|||||||0.44|||||||ANOVA|F(1,93)=0.62||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on insula activation. Here we report the results of the analysis of the condition X family history X sex interaction.||||.44
72332142|NCT04925076|144188847|SUPERIORITY|||||||0.27|||||||ANOVA|F(1,93)=1.23||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on insula activation. Here we report the results of the analysis of the condition X sex interaction.||||.27
72332143|NCT04925076|144188847|SUPERIORITY|||||||0.06|||||||ANOVA|F(1,93)=3.66||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on insula activation. Here we report the results of the analysis of the condition X family history interaction.||||.06
72332144|NCT04925076|144188847|SUPERIORITY|||||||0.73|||||||ANOVA|F(1,93)=0.13||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on insula activation. Here we report the results of the analysis of the family history X sex interaction.||||.73
72332145|NCT04925076|144188847|SUPERIORITY|||||||0.047|||||||ANOVA|F(1,93)=4.04||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on insula activation. Here we report the results of the analysis of the main effect of condition.||||.047
72332146|NCT04925076|144188847|SUPERIORITY|||||||0.97|||||||ANOVA|F(1,93)=0.001||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on insula activation. Here we report the results of the analysis of the main effect of family history.||||.97
72332147|NCT04925076|144188847|SUPERIORITY|||||||0.82|||||||ANOVA|F(1,93)=0.05||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on insula activation. Here we report the results of the analysis of the main effect of sex.||||.82
72332148|NCT04925076|144188848|SUPERIORITY|||||||0.45|||||||ANOVA|F(1,93)=0.57||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on postcentral gyrus activation. Here we report the results of the analysis of the condition X family history X sex interaction.||||0.45
72332149|NCT04925076|144188848|SUPERIORITY|||||||0.59|||||||ANOVA|F(1,93)=0.29||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on postcentral gyrus activation. Here we report the results of the analysis of the condition X sex interaction.||||.59
72332150|NCT04925076|144188848|SUPERIORITY|||||||0.07|||||||ANOVA|F(1,93)=3.41||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on postcentral gyrus activation. Here we report the results of the analysis of the condition X family history interaction.||||.07
72332151|NCT04925076|144188848|SUPERIORITY|||||||0.61|||||||ANOVA|F(1,93)=0.26||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on postcentral gyrus activation. Here we report the results of the analysis of the family history X sex interaction.||||.61
72332152|NCT04925076|144188848|SUPERIORITY|||||||0.82|||||||ANOVA|F(1,93)=0.05||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on postcentral gyrus activation. Here we report the results of the analysis of the main effect of condition.||||.82
72332153|NCT04925076|144188848|SUPERIORITY|||||||0.63|||||||ANOVA|F(1,93)=0.23||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on postcentral gyrus activation. Here we report the results of the analysis of the main effect of family history.||||.63
72332154|NCT04925076|144188848|SUPERIORITY|||||||0.55|||||||ANOVA|F(1,93)=0.36||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on postcentral gyrus activation. Here we report the results of the analysis of the main effect of sex.||||.55
72332155|NCT04925076|144188849|SUPERIORITY|||||||0.57|||||||ANOVA|F(1,93)=0.32||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on thalamus activation. Here we report the results of the analysis of the condition X family history X sex interaction.||||.57
72332156|NCT04925076|144188849|SUPERIORITY|||||||0.14|||||||ANOVA|F(1,93)=2.17||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on thalamus activation. Here we report the results of the analysis of the condition X sex interaction.||||.14
72332157|NCT04925076|144188849|SUPERIORITY|||||||0.69|||||||ANOVA|F(1,93)=0.32||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on thalamus activation. Here we report the results of the analysis of the condition X family history interaction.||||.69
72332158|NCT04925076|144188849|SUPERIORITY|||||||0.34|||||||ANOVA|F(1,93)=0.92||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on thalamus activation. Here we report the results of the analysis of the family history X sex interaction.||||.34
72332159|NCT04925076|144188849|SUPERIORITY|||||||0.29|||||||ANOVA|F(1,93)=1.16||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on thalamus activation. Here we report the results of the analysis of the main effect of condition.||||0.29
72332160|NCT04925076|144188849|SUPERIORITY|||||||0.95|||||||ANOVA|F(1,93)=0.004||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on thalamus activation. Here we report the results of the analysis of the main effect of family history.||||.95
72332161|NCT04925076|144188849|SUPERIORITY|||||||0.11|||||||ANOVA|F(1,93)=2.65||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on thalamus activation. Here we report the results of the analysis of the main effect of sex.||||.11
72422740|NCT03502616|144356420|SUPERIORITY||LS mean difference|0.06|STANDARD_ERROR_OF_MEAN|0.161||0.7291|TWO_SIDED|95.0|-0.26|0.37|||Mixed Models Analysis|||Week 2: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.37|-0.26|0.7291
72332162|NCT04115748|144188871|SUPERIORITY||Difference in response rates|32.1||||0.048|TWO_SIDED|95.0|2.6|61.6||The stratification factors (Geographic Region, Concurrent Use of conventional synthetic (cs) DMARD(s) and/or Apremilast at Randomization, Prior Use of biologic (bio) DMARD(s)) and treatment groups were included in the imputation model as covariates.|Multiple imputation method|||||61.6|2.6|0.048
72332163|NCT04115748|144188871|SUPERIORITY||Difference in response rates|18.4||||0.23|TWO_SIDED|95.0|-12.4|49.2||The stratification factors (geographic region, concurrent use of csDMARD(s) and/or apremilast at randomization, prior use of bioDMARD(s)) and treatment groups were included in the imputation model as covariates.|Multiple imputation method|||||49.2|-12.4|0.23
72332164|NCT04115748|144188873|SUPERIORITY||Difference in response rates|16.1||||0.17|TWO_SIDED|95.0|-9.7|41.9||P-value was calculated by logistic regression with treatment group and stratification factors (geographic region and concurrent use of csDMARDs and/or apremilast at randomization) in the model.|Regression, Logistic||95% confidence interval (CI) for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||41.9|-9.7|0.17
72332165|NCT04115748|144188873|SUPERIORITY||Difference in response rates|11.7||||0.27|TWO_SIDED|95.0|-13.3|36.6||P-value was calculated by logistic regression with treatment group and stratification factors (geographic region and concurrent use of csDMARDs and/or apremilast at randomization) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||36.6|-13.3|0.27
72332166|NCT04115748|144188873|SUPERIORITY||Difference in response rates|10.5||||0.42|TWO_SIDED|95.0|-20.4|41.5||P-value was calculated by logistic regression with treatment group and stratification factors (geographic region and concurrent use of csDMARDs and/or apremilast at randomization) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 8||41.5|-20.4|0.42
72332167|NCT04115748|144188873|SUPERIORITY||Difference in response rates|15.8||||0.26|TWO_SIDED|95.0|-16.0|47.6||P-value was calculated by logistic regression with treatment group and stratification factors (geographic region and concurrent use of csDMARDs and/or apremilast at randomization) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 8||47.6|-16.0|0.26
72332168|NCT04115748|144188873|SUPERIORITY||Difference in response rates|28.7||||0.062|TWO_SIDED|95.0|-5.0|62.3||P-value was calculated by logistic regression with treatment group and stratification factors (geographic region and concurrent use of csDMARDs and/or apremilast at randomization) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 12||62.3|-5.0|0.062
72332169|NCT04115748|144188873|SUPERIORITY||Difference in response rates|31.6||||0.047|TWO_SIDED|95.0|-1.5|64.6||P-value was calculated by logistic regression with treatment group and stratification factors (geographic region and concurrent use of csDMARDs and/or apremilast at randomization) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 12||64.6|-1.5|0.047
72332170|NCT04115748|144188873|SUPERIORITY||Difference in response rates|7.8||||0.58|TWO_SIDED|95.0|-24.6|40.2||P-value was calculated by logistic regression with treatment group and stratification factors (geographic region and concurrent use of csDMARDs and/or apremilast at randomization) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||40.2|-24.6|0.58
72332171|NCT04115748|144188873|SUPERIORITY||Difference in response rates|16.8||||0.27|TWO_SIDED|95.0|-16.2|49.9||P-value was calculated by logistic regression with treatment group and stratification factors (geographic region and concurrent use of csDMARDs and/or apremilast at randomization) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||49.9|-16.2|0.27
72332172|NCT04115748|144188874|SUPERIORITY||Difference in response rates|5.3|||||TWO_SIDED|95.0|-9.9|20.4|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||20.4|-9.9|
72332173|NCT04115748|144188874|SUPERIORITY||Difference in response rates|0.0|||||TWO_SIDED|95.0|-5.3|5.3|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||5.3|-5.3|
72332174|NCT04115748|144188874|SUPERIORITY||Difference in response rates|-5.3|||||TWO_SIDED|95.0|-27.6|17.1|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 8||17.1|-27.6|
72332175|NCT04115748|144188874|SUPERIORITY||Difference in response rates|-10.5|||||TWO_SIDED|95.0|-29.6|8.5|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 8||8.5|-29.6|
72332176|NCT04115748|144188874|SUPERIORITY||Difference in response rates|5.8|||||TWO_SIDED|95.0|-17.2|28.9|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 12||28.9|-17.2|
72332177|NCT04115748|144188874|SUPERIORITY||Difference in response rates|0.0|||||TWO_SIDED|95.0|-19.5|19.5|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 12||19.5|-19.5|
72332178|NCT04115748|144188874|SUPERIORITY||Difference in response rates|5.6|||||TWO_SIDED|95.0|-10.3|21.4|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||21.4|-10.3|
72422741|NCT03502616|144356420|SUPERIORITY||LS mean difference|-0.41|STANDARD_ERROR_OF_MEAN|0.184||0.0257|TWO_SIDED|95.0|-0.78|-0.05|||Mixed Models Analysis|||Week 4: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-0.05|-0.78|0.0257
72422742|NCT03502616|144356420|SUPERIORITY||LS mean difference|-0.86|STANDARD_ERROR_OF_MEAN|0.227||0.0002|TWO_SIDED|95.0|-1.31|-0.42|||Mixed Models Analysis|||Week 8: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-0.42|-1.31|0.0002
72422743|NCT03502616|144356420|SUPERIORITY||LS mean difference|-0.63|STANDARD_ERROR_OF_MEAN|0.216||0.0041|TWO_SIDED|95.0|-1.05|-0.2|||Mixed Models Analysis|||Week 12: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-0.20|-1.05|0.0041
72332179|NCT04115748|144188874|SUPERIORITY||Difference in response rates|10.5|||||TWO_SIDED|95.0|-8.4|29.5|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||29.5|-8.4|
72422744|NCT03502616|144356420|SUPERIORITY||LS mean difference|-0.59|STANDARD_ERROR_OF_MEAN|0.215||0.0062|TWO_SIDED|95.0|-1.02|-0.17|||Mixed Models Analysis|||Week 16: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-0.17|-1.02|0.0062
72422745|NCT03502616|144356420|SUPERIORITY||LS mean difference|-0.63|STANDARD_ERROR_OF_MEAN|0.255||0.014|TWO_SIDED|95.0|-1.13|-0.13|||Mixed Models Analysis|||Week 24: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-0.13|-1.13|0.0140
72422746|NCT03502616|144356420|SUPERIORITY||LS mean difference|-0.66|STANDARD_ERROR_OF_MEAN|0.225||0.0035|TWO_SIDED|95.0|-1.11|-0.22|||Mixed Models Analysis|||Week 32: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-0.22|-1.11|0.0035
72422747|NCT03502616|144356420|SUPERIORITY||LS mean difference|-0.47|STANDARD_ERROR_OF_MEAN|0.253||0.0645|TWO_SIDED|95.0|-0.97|0.03|||Mixed Models Analysis|||Week 40: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.03|-0.97|0.0645
72332180|NCT04115748|144188880|SUPERIORITY||Difference in response rates|16.1|||||TWO_SIDED|95.0|-9.7|41.9|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||41.9|-9.7|
72332181|NCT04115748|144188880|SUPERIORITY||Difference in response rates|6.1|||||TWO_SIDED|95.0|-16.5|28.8|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||28.8|-16.5|
72332182|NCT04115748|144188880|SUPERIORITY||Difference in response rates|23.9|||||TWO_SIDED|95.0|-8.8|56.6|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||56.6|-8.8|
72422748|NCT03502616|144356420|SUPERIORITY||LS mean difference|-0.54|STANDARD_ERROR_OF_MEAN|0.255||0.0341|TWO_SIDED|95.0|-1.05|-0.04|||Mixed Models Analysis|||Week 48: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-0.04|-1.05|0.0341
72422749|NCT03502616|144356421|SUPERIORITY||LS mean difference|-0.22|STANDARD_ERROR_OF_MEAN|0.056||0.0001|TWO_SIDED|95.0|-0.33|-0.11|||Mixed Models Analysis|||Week 2: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-0.11|-0.33|0.0001
72422750|NCT03502616|144356421|SUPERIORITY||LS mean difference|-0.33|STANDARD_ERROR_OF_MEAN|0.068|<|0.0001|TWO_SIDED|95.0|-0.47|-0.2|||Mixed Models Analysis|||Week 4: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-0.20|-0.47|<0.0001
72422751|NCT03502616|144356421|SUPERIORITY||LS mean difference|-0.46|STANDARD_ERROR_OF_MEAN|0.075|<|0.0001|TWO_SIDED|95.0|-0.61|-0.31|||Mixed Models Analysis|||Week 8: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-0.31|-0.61|<0.0001
72422752|NCT03502616|144356421|SUPERIORITY||LS mean difference|-0.47|STANDARD_ERROR_OF_MEAN|0.075|<|0.0001|TWO_SIDED|95.0|-0.62|-0.32|||Mixed Models Analysis|||Week 12: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-0.32|-0.62|<0.0001
72422753|NCT03502616|144356421|SUPERIORITY||LS mean difference|-0.52|STANDARD_ERROR_OF_MEAN|0.077|<|0.0001|TWO_SIDED|95.0|-0.67|-0.37|||Mixed Models Analysis|||Week 16: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-0.37|-0.67|<0.0001
72422754|NCT03502616|144356421|SUPERIORITY||LS mean difference|-0.29|STANDARD_ERROR_OF_MEAN|0.086||0.0008|TWO_SIDED|95.0|-0.46|-0.12|||LS mean difference|||Week 24: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-0.12|-0.46|0.0008
72422755|NCT03502616|144356421|SUPERIORITY||LS mean difference|-0.22|STANDARD_ERROR_OF_MEAN|0.086||0.0116|TWO_SIDED|95.0|-0.39|-0.05|||Mixed Models Analysis|||Week 32: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-0.05|-0.39|0.0116
72422756|NCT03502616|144356421|SUPERIORITY||LS mean difference|-0.19|STANDARD_ERROR_OF_MEAN|0.093||0.0416|TWO_SIDED|95.0|-0.37|-0.01|||Mixed Models Analysis|||Week 40: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-0.01|-0.37|0.0416
72422757|NCT03502616|144356421|SUPERIORITY||LS mean difference|-0.16|STANDARD_ERROR_OF_MEAN|0.092||0.0915|TWO_SIDED|95.0|-0.34|0.03|||Mixed Models Analysis|||Week 48: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.03|-0.34|0.0915
72422758|NCT03502616|144356422|SUPERIORITY||LS mean difference|2.85|STANDARD_ERROR_OF_MEAN|0.706|<|0.0001|TWO_SIDED|95.0|1.46|4.24|||Mixed Models Analysis|||Week 2: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||4.24|1.46|<0.0001
72422759|NCT03502616|144356422|SUPERIORITY||LS mean difference|3.61|STANDARD_ERROR_OF_MEAN|0.761|<|0.0001|TWO_SIDED|95.0|2.11|5.1|||Mixed Models Analysis|||Week 4: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||5.10|2.11|<0.0001
72422760|NCT03502616|144356422|SUPERIORITY||LS mean difference|5.42|STANDARD_ERROR_OF_MEAN|0.902|<|0.0001|TWO_SIDED|95.0|3.65|7.2|||Mixed Models Analysis|||Week 8: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||7.20|3.65|<0.0001
72422761|NCT03502616|144356422|SUPERIORITY||LS mean difference|5.01|STANDARD_ERROR_OF_MEAN|0.943|<|0.0001|TWO_SIDED|95.0|3.15|6.86|||Mixed Models Analysis|||Week 12: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||6.86|3.15|<0.0001
72422762|NCT03502616|144356422|SUPERIORITY||LS mean difference|3.43|STANDARD_ERROR_OF_MEAN|1.012||0.0008|TWO_SIDED|95.0|1.44|5.42|||Mixed Models Analysis|||Week 16: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||5.42|1.44|0.0008
72422763|NCT03502616|144356422|SUPERIORITY||LS mean difference|1.58|STANDARD_ERROR_OF_MEAN|1.064||0.139|TWO_SIDED|95.0|-0.52|3.68|||Mixed Models Analysis|||Week 24: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||3.68|-0.52|0.1390
72422764|NCT03502616|144356422|SUPERIORITY||LS mean difference|0.66|STANDARD_ERROR_OF_MEAN|1.024||0.5217|TWO_SIDED|95.0|-1.36|2.67|||Mixed Models Analysis|||Week 32: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||2.67|-1.36|0.5217
72422765|NCT03502616|144356422|SUPERIORITY||LS mean difference|1.51|STANDARD_ERROR_OF_MEAN|1.027||0.1415|TWO_SIDED|95.0|-0.51|3.54|||Mixed Models Analysis|||Week 40: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||3.54|-0.51|0.1415
72422766|NCT03502616|144356422|SUPERIORITY||LS mean difference|2.19|STANDARD_ERROR_OF_MEAN|1.128||0.0533|TWO_SIDED|95.0|-0.03|4.41|||Mixed Models Analysis|||Week 48: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||4.41|-0.03|0.0533
72422767|NCT03502616|144356423|SUPERIORITY||LS mean difference|1.25|STANDARD_ERROR_OF_MEAN|0.352||0.0005|TWO_SIDED|95.0|0.55|1.94|||Mixed Models Analysis|||Week 2: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||1.94|0.55|0.0005
72422768|NCT03502616|144356423|SUPERIORITY||LS mean difference|1.7|STANDARD_ERROR_OF_MEAN|0.381|<|0.0001|TWO_SIDED|95.0|0.95|2.45|||Mixed Models Analysis|||Week 4: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||2.45|0.95|<0.0001
72422769|NCT03502616|144356423|SUPERIORITY||LS mean difference|2.19|STANDARD_ERROR_OF_MEAN|0.423|<|0.0001|TWO_SIDED|95.0|1.35|3.02|||Mixed Models Analysis|||Week 8: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||3.02|1.35|<0.0001
72422770|NCT03502616|144356423|SUPERIORITY||LS mean difference|1.98|STANDARD_ERROR_OF_MEAN|0.439|<|0.0001|TWO_SIDED|95.0|1.11|2.84|||Mixed Models Analysis|||Week 12: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||2.84|1.11|<0.0001
72422771|NCT03502616|144356423|SUPERIORITY||LS mean difference|1.56|STANDARD_ERROR_OF_MEAN|0.454||0.0007|TWO_SIDED|95.0|0.67|2.45|||Mixed Models Analysis|||Week 16: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||2.45|0.67|0.0007
72422772|NCT03502616|144356423|SUPERIORITY||LS mean difference|0.62|STANDARD_ERROR_OF_MEAN|0.485||0.2018|TWO_SIDED|95.0|-0.33|1.58|||Mixed Models Analysis|||Week 24: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||1.58|-0.33|0.2018
72422773|NCT03502616|144356423|SUPERIORITY||LS mean difference|0.22|STANDARD_ERROR_OF_MEAN|0.465||0.6432|TWO_SIDED|95.0|-0.7|1.13|||Mixed Models Analysis|||Week 32: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||1.13|-0.70|0.6432
72422774|NCT03502616|144356423|SUPERIORITY||LS mean difference|0.39|STANDARD_ERROR_OF_MEAN|0.47||0.4092|TWO_SIDED|95.0|-0.54|1.31|||Mixed Models Analysis|||Week 40: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||1.31|-0.54|0.4092
72422775|NCT03502616|144356423|SUPERIORITY||LS mean difference|0.82|STANDARD_ERROR_OF_MEAN|0.506||0.107|TWO_SIDED|95.0|-0.18|1.81|||Mixed Models Analysis|||Week 48: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||1.81|-0.18|0.1070
72422776|NCT03502616|144356424|SUPERIORITY||LS mean difference|1.62|STANDARD_ERROR_OF_MEAN|0.428||0.0002|TWO_SIDED|95.0|0.78|2.46|||Mixed Models Analysis|||Week 2: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||2.46|0.78|0.0002
72422777|NCT03502616|144356424|SUPERIORITY||LS mean difference|1.92|STANDARD_ERROR_OF_MEAN|0.466|<|0.0001|TWO_SIDED|95.0|1.0|2.84|||Mixed Models Analysis|||Week 4: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||2.84|1.00|<0.0001
72422778|NCT03502616|144356424|SUPERIORITY||LS mean difference|3.26|STANDARD_ERROR_OF_MEAN|0.549|<|0.0001|TWO_SIDED|95.0|2.18|4.34|||Mixed Models Analysis|||Week 8: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||4.34|2.18|<0.0001
72422779|NCT03502616|144356424|SUPERIORITY||LS mean difference|3.04|STANDARD_ERROR_OF_MEAN|0.564|<|0.0001|TWO_SIDED|95.0|1.93|4.15|||Mixed Models Analysis|||Week 12: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||4.15|1.93|<0.0001
72422780|NCT03502616|144356424|SUPERIORITY||LS mean difference|1.87|STANDARD_ERROR_OF_MEAN|0.621||0.0028|TWO_SIDED|95.0|0.65|3.09|||Mixed Models Analysis|||Week 16: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||3.09|0.65|0.0028
72422781|NCT03502616|144356424|SUPERIORITY||LS mean difference|0.97|STANDARD_ERROR_OF_MEAN|0.638||0.1289|TWO_SIDED|95.0|-0.28|2.23|||Mixed Models Analysis|||Week 24: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||2.23|-0.28|0.1289
72422782|NCT03502616|144356424|SUPERIORITY||LS mean difference|0.45|STANDARD_ERROR_OF_MEAN|0.616||0.4698|TWO_SIDED|95.0|-0.77|1.66|||Mixed Models Analysis|||Week 32: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||1.66|-0.77|0.4698
72422783|NCT03502616|144356424|SUPERIORITY||LS mean difference|1.13|STANDARD_ERROR_OF_MEAN|0.603||0.0616|TWO_SIDED|95.0|-0.06|2.32|||Mixed Models Analysis|||Week 40: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||2.32|-0.06|0.0616
72422784|NCT03502616|144356424|SUPERIORITY||LS mean difference|1.37|STANDARD_ERROR_OF_MEAN|0.681||0.0455|TWO_SIDED|95.0|0.03|2.71|||Mixed Models Analysis|||Week 48: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||2.71|0.03|0.0455
72422785|NCT03502616|144356425|SUPERIORITY||LS mean difference|-0.88|STANDARD_ERROR_OF_MEAN|0.185|<|0.0001|TWO_SIDED|95.0|-1.25|-0.52|||Mixed Models Analysis|||Week 2: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-0.52|-1.25|<0.0001
72422786|NCT03502616|144356425|SUPERIORITY||LS mean difference|-1.22|STANDARD_ERROR_OF_MEAN|0.215|<|0.0001|TWO_SIDED|95.0|-1.65|-0.8|||Mixed Models Analysis|||Week 4: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-0.80|-1.65|<0.0001
72422787|NCT03502616|144356425|SUPERIORITY||LS mean difference|-1.71|STANDARD_ERROR_OF_MEAN|0.232|<|0.0001|TWO_SIDED|95.0|-2.17|-1.26|||Mixed Models Analysis|||Week 8: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-1.26|-2.17|<0.0001
72422788|NCT03502616|144356425|SUPERIORITY||LS mean difference|-1.72|STANDARD_ERROR_OF_MEAN|0.247|<|0.0001|TWO_SIDED|95.0|-2.2|-1.23|||Mixed Models Analysis|||Week 12: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-1.23|-2.20|<0.0001
72422789|NCT03502616|144356425|SUPERIORITY||LS mean difference|-1.56|STANDARD_ERROR_OF_MEAN|0.26|<|0.0001|TWO_SIDED|95.0|-2.07|-1.05|||Mixed Models Analysis|||Week 16: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-1.05|-2.07|<0.0001
72422790|NCT03502616|144356425|SUPERIORITY||LS mean difference|-0.56|STANDARD_ERROR_OF_MEAN|0.281||0.0483|TWO_SIDED|95.0|-1.11|0.0|||Mixed Models Analysis|||Week 24: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-0.00|-1.11|0.0483
72422791|NCT03502616|144356425|SUPERIORITY||LS mean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.286||0.0357|TWO_SIDED|95.0|-1.17|-0.04|||Mixed Models Analysis|||Week 32: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-0.04|-1.17|0.0357
72422792|NCT03502616|144356425|SUPERIORITY||LS mean difference|-0.55|STANDARD_ERROR_OF_MEAN|0.278||0.0508|TWO_SIDED|95.0|-1.09|0.0|||Mixed Models Analysis|||Week 40: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.00|-1.09|0.0508
72422793|NCT03502616|144356425|SUPERIORITY||LS mean difference|-0.53|STANDARD_ERROR_OF_MEAN|0.282||0.0614|TWO_SIDED|95.0|-1.08|0.03|||Mixed Models Analysis|||Week 48: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.03|-1.08|0.0614
72422794|NCT03502616|144356426|SUPERIORITY||LS mean difference|-0.89|STANDARD_ERROR_OF_MEAN|0.186|<|0.0001|TWO_SIDED|95.0|-1.26|-0.53|||Mixed Models Analysis|||Week 2: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-0.53|-1.26|<0.0001
72422795|NCT03502616|144356426|SUPERIORITY||LS mean difference|-1.34|STANDARD_ERROR_OF_MEAN|0.21|<|0.0001|TWO_SIDED|95.0|-1.75|-0.92|||Mixed Models Analysis|||Week 4: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-0.92|-1.75|<0.0001
72422796|NCT03502616|144356426|SUPERIORITY||LS mean difference|-1.98|STANDARD_ERROR_OF_MEAN|0.221|<|0.0001|TWO_SIDED|95.0|-2.41|-1.54|||Mixed Models Analysis|||Week 8: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-1.54|-2.41|<0.0001
72422797|NCT03502616|144356426|SUPERIORITY||LS mean difference|-1.89|STANDARD_ERROR_OF_MEAN|0.245|<|0.0001|TWO_SIDED|95.0|-2.37|-1.4|||Mixed Models Analysis|||Week 12: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-1.40|-2.37|<0.0001
72422798|NCT03502616|144356426|SUPERIORITY||LS mean difference|-1.62|STANDARD_ERROR_OF_MEAN|0.243|<|0.0001|TWO_SIDED|95.0|-2.1|-1.14|||Mixed Models Analysis|||Week 16: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-1.14|-2.10|<0.0001
72422799|NCT03502616|144356426|SUPERIORITY||LS mean difference|-0.51|STANDARD_ERROR_OF_MEAN|0.261||0.0492|TWO_SIDED|95.0|-1.03|0.0|||Mixed Models Analysis|||Week 24: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-0.00|-1.03|0.0492
72422800|NCT03502616|144356426|SUPERIORITY||LS mean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.266||0.2614|TWO_SIDED|95.0|-0.82|0.22|||Mixed Models Analysis|||Week 32: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.22|-0.82|0.2614
72422801|NCT03502616|144356426|SUPERIORITY||LS mean difference|-0.49|STANDARD_ERROR_OF_MEAN|0.272||0.0722|TWO_SIDED|95.0|-1.03|0.04|||Mixed Models Analysis|||Week 40: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.04|-1.03|0.0722
72422802|NCT03502616|144356426|SUPERIORITY||LS mean difference|-0.7|STANDARD_ERROR_OF_MEAN|0.275||0.0121|TWO_SIDED|95.0|-1.24|-0.15|||Mixed Models Analysis|||Week 48: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-0.15|-1.24|0.0121
72422803|NCT03502616|144356427|SUPERIORITY||LS mean difference|-0.92|STANDARD_ERROR_OF_MEAN|0.207|<|0.0001|TWO_SIDED|95.0|-1.33|-0.51|||Mixed Models Analysis|||Week 2: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-0.51|-1.33|<0.0001
72422804|NCT03502616|144356427|SUPERIORITY||LS mean difference|-1.6|STANDARD_ERROR_OF_MEAN|0.216|<|0.0001|TWO_SIDED|95.0|-2.02|-1.17|||Mixed Models Analysis|||Week 4: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-1.17|-2.02|<0.0001
72422805|NCT03502616|144356427|SUPERIORITY||LS mean difference|-2.02|STANDARD_ERROR_OF_MEAN|0.244|<|0.0001|TWO_SIDED|95.0|-2.5|-1.54|||Mixed Models Analysis|||Week 8: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-1.54|-2.50|<0.0001
72422806|NCT03502616|144356427|SUPERIORITY||LS mean difference|-2.0|STANDARD_ERROR_OF_MEAN|0.254|<|0.0001|TWO_SIDED|95.0|-2.5|-1.5|||Mixed Models Analysis|||Week 12: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-1.50|-2.50|<0.0001
72422807|NCT03502616|144356427|SUPERIORITY||LS mean difference|-1.84|STANDARD_ERROR_OF_MEAN|0.26|<|0.0001|TWO_SIDED|95.0|-2.35|-1.32|||Mixed Models Analysis|||Week 16: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-1.32|-2.35|<0.0001
72422808|NCT03502616|144356427|SUPERIORITY||LS mean difference|-0.48|STANDARD_ERROR_OF_MEAN|0.274||0.0785|TWO_SIDED|95.0|-1.02|0.06|||Mixed Models Analysis|||Week 24: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.06|-1.02|0.0785
72422809|NCT03502616|144356427|SUPERIORITY||LS mean difference|-0.28|STANDARD_ERROR_OF_MEAN|0.275||0.3047|TWO_SIDED|95.0|-0.82|0.26|||Mixed Models Analysis|||Week 32: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.26|-0.82|0.3047
72422810|NCT03502616|144356427|SUPERIORITY||LS mean difference|-0.47|STANDARD_ERROR_OF_MEAN|0.283||0.1009|TWO_SIDED|95.0|-1.02|0.09|||Mixed Models Analysis|||Week 40: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.09|-1.02|0.1009
72332183|NCT04115748|144188880|SUPERIORITY||Difference in response rates|27.1|||||TWO_SIDED|95.0|-5.2|59.4|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||59.4|-5.2|
72332184|NCT04115748|144188881|SUPERIORITY||Difference in response rates|0.0|||||TWO_SIDED|95.0|-5.1|5.1|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||5.1|-5.1|
72332185|NCT04115748|144188881|SUPERIORITY||Difference in response rates|0.0|||||TWO_SIDED|95.0|-5.3|5.3|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||5.3|-5.3|
72422811|NCT03502616|144356427|SUPERIORITY||LS mean difference|-0.51|STANDARD_ERROR_OF_MEAN|0.287||0.0764|TWO_SIDED|95.0|-1.08|0.05|||Mixed Models Analysis|||Week 48: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.05|-1.08|0.0764
72422812|NCT03502616|144356428|SUPERIORITY||LS mean difference|-0.42|STANDARD_ERROR_OF_MEAN|0.159||0.0089|TWO_SIDED|95.0|-0.73|-0.11|||Mixed Models Analysis|||Week 2: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-0.11|-0.73|0.0089
72332186|NCT04115748|144188881|SUPERIORITY||Difference in response rates|11.7|||||TWO_SIDED|95.0|-13.3|36.6|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||36.6|-13.3|
72332187|NCT04115748|144188881|SUPERIORITY||Difference in response rates|5.5|||||TWO_SIDED|95.0|-16.4|27.4|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||27.4|-16.4|
72332188|NCT04115748|144188882|SUPERIORITY||Difference in response rates|15.8||||0.2|TWO_SIDED|95.0|-13.6|45.2||P-value was calculated by logistic regression with treatment group and stratification factors (geographic region and concurrent use of csDMARDs and/or apremilast at randomization) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 2||45.2|-13.6|0.20
72332189|NCT04115748|144188882|SUPERIORITY||Difference in response rates|-5.0||||0.6|TWO_SIDED|95.0|-27.8|17.8||P-value was calculated by logistic regression with treatment group and stratification factors (geographic region and concurrent use of csDMARDs and/or apremilast at randomization) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 2||17.8|-27.8|0.60
72332190|NCT04115748|144188882|SUPERIORITY||Difference in response rates|42.6||||0.008|TWO_SIDED|95.0|11.5|73.8||P-value was calculated by logistic regression with treatment group and stratification factors (geographic region and concurrent use of csDMARDs and/or apremilast at randomization) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||73.8|11.5|0.008
72332191|NCT04115748|144188882|SUPERIORITY||Difference in response rates|17.8||||0.17|TWO_SIDED|95.0|-12.0|47.6||P-value was calculated by logistic regression with treatment group and stratification factors (geographic region and concurrent use of csDMARDs and/or apremilast at randomization) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||47.6|-12.0|0.17
72332192|NCT04115748|144188882|SUPERIORITY||Difference in response rates|42.1||||0.011|TWO_SIDED|95.0|8.1|76.2||P-value was calculated by logistic regression with treatment group and stratification factors (geographic region and concurrent use of csDMARDs and/or apremilast at randomization) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 8||76.2|8.1|0.011
72422813|NCT03502616|144356428|SUPERIORITY||LS mean difference|-0.77|STANDARD_ERROR_OF_MEAN|0.179|<|0.0001|TWO_SIDED|95.0|-1.12|-0.42|||Mixed Models Analysis|||Week 4: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-0.42|-1.12|<0.0001
72422814|NCT03502616|144356428|SUPERIORITY||LS mean difference|-1.1|STANDARD_ERROR_OF_MEAN|0.202|<|0.0001|TWO_SIDED|95.0|-1.5|-0.7|||Mixed Models Analysis|||Week 8: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-0.70|-1.50|<0.0001
72332193|NCT04115748|144188882|SUPERIORITY||Difference in response rates|5.3||||0.69|TWO_SIDED|95.0|-30.1|40.6||P-value was calculated by logistic regression with treatment group and stratification factors (geographic region and concurrent use of csDMARDs and/or apremilast at randomization) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 8||40.6|-30.1|0.69
72332194|NCT04115748|144188882|SUPERIORITY||Difference in response rates|35.7||||0.033|TWO_SIDED|95.0|0.9|70.4||P-value was calculated by logistic regression with treatment group and stratification factors (geographic region and concurrent use of csDMARDs and/or apremilast at randomization) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 12||70.4|0.9|0.033
72332195|NCT04115748|144188882|SUPERIORITY||Difference in response rates|21.1||||0.19|TWO_SIDED|95.0|-15.2|57.4||P-value was calculated by logistic regression with treatment group and stratification factors (geographic region and concurrent use of csDMARDs and/or apremilast at randomization) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 12||57.4|-15.2|0.19
72332196|NCT04115748|144188882|SUPERIORITY||Difference in response rates|43.9||||0.007|TWO_SIDED|95.0|12.4|75.4||P-value was calculated by logistic regression with treatment group and stratification factors (geographic region and concurrent use of csDMARDs and/or apremilast at randomization) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||75.4|12.4|0.007
72332197|NCT04115748|144188882|SUPERIORITY||Difference in response rates|7.6||||0.63|TWO_SIDED|95.0|-28.8|44.1||P-value was calculated by logistic regression with treatment group and stratification factors (geographic region and concurrent use of csDMARDs and/or apremilast at randomization) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||44.1|-28.8|0.63
72422815|NCT03502616|144356428|SUPERIORITY||LS mean difference|-1.29|STANDARD_ERROR_OF_MEAN|0.21|<|0.0001|TWO_SIDED|95.0|-1.71|-0.88|||Mixed Models Analysis|||Week 12: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-0.88|-1.71|<0.0001
72422816|NCT03502616|144356428|SUPERIORITY||LS mean difference|-1.23|STANDARD_ERROR_OF_MEAN|0.217|<|0.0001|TWO_SIDED|95.0|-1.66|-0.8|||Mixed Models Analysis|||Week 16: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-0.80|-1.66|<0.0001
72422817|NCT03502616|144356428|SUPERIORITY||LS mean difference|-0.33|STANDARD_ERROR_OF_MEAN|0.242||0.1686|TWO_SIDED|95.0|-0.81|0.14|||Mixed Models Analysis|||Week 24: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.14|-0.81|0.1686
72332198|NCT04115748|144188883|SUPERIORITY||Difference in response rates|0.0||||0.98|TWO_SIDED|95.0|-19.5|19.5||P-value was calculated by logistic regression with treatment group and stratification factors (geographic region and concurrent use of csDMARDs and/or apremilast at randomization) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 2||19.5|-19.5|0.98
72332199|NCT04115748|144188883|SUPERIORITY||Difference in response rates|-5.3||||0.5|TWO_SIDED|95.0|-20.7|10.2||P-value was calculated by logistic regression with treatment group and stratification factors (geographic region and concurrent use of csDMARDs and/or apremilast at randomization) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 2||10.2|-20.7|0.50
72332200|NCT04115748|144188883|SUPERIORITY||Difference in response rates|5.5||||0.54|TWO_SIDED|95.0|-16.4|27.4||P-value was calculated by logistic regression with treatment group and stratification factors (geographic region and concurrent use of csDMARDs and/or apremilast at randomization) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||27.4|-16.4|0.54
72332201|NCT04115748|144188883|SUPERIORITY||Difference in response rates|0.6||||0.92|TWO_SIDED|95.0|-19.0|20.1||P-value was calculated by logistic regression with treatment group and stratification factors (geographic region and concurrent use of csDMARDs and/or apremilast at randomization) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||20.1|-19.0|0.92
72332202|NCT04115748|144188883|SUPERIORITY||Difference in response rates|21.1||||0.13|TWO_SIDED|95.0|-9.3|51.4||P-value was calculated by logistic regression with treatment group and stratification factors (geographic region and concurrent use of csDMARDs and/or apremilast at randomization) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 8||51.4|-9.3|0.13
72332203|NCT04115748|144188883|SUPERIORITY||Difference in response rates|15.8||||0.22|TWO_SIDED|95.0|-13.6|45.2||P-value was calculated by logistic regression with treatment group and stratification factors (geographic region and concurrent use of csDMARDs and/or apremilast at randomization) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 8||45.2|-13.6|0.22
72332204|NCT04115748|144188883|SUPERIORITY||Difference in response rates|45.0||||0.007|TWO_SIDED|95.0|12.8|77.2||P-value was calculated by logistic regression with treatment group and stratification factors (geographic region and concurrent use of csDMARDs and/or apremilast at randomization) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 12||77.2|12.8|0.007
72332205|NCT04115748|144188883|SUPERIORITY||Difference in response rates|31.6||||0.039|TWO_SIDED|95.0|0.2|63.0||P-value was calculated by logistic regression with treatment group and stratification factors (geographic region and concurrent use of csDMARDs and/or apremilast at randomization) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 12||63.0|0.2|0.039
72332206|NCT04115748|144188883|SUPERIORITY||Difference in response rates|12.8||||0.34|TWO_SIDED|95.0|-18.4|44.0||P-value was calculated by logistic regression with treatment group and stratification factors (geographic region and concurrent use of csDMARDs and/or apremilast at randomization) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||44.0|-18.4|0.34
72332207|NCT04115748|144188883|SUPERIORITY||Difference in response rates|32.4||||0.04|TWO_SIDED|95.0|-0.1|64.9||P-value was calculated by logistic regression with treatment group and stratification factors (geographic region and concurrent use of csDMARDs and/or apremilast at randomization) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||64.9|-0.1|0.040
72332208|NCT04115748|144188884|SUPERIORITY||Difference in response rates|5.3|||||TWO_SIDED|95.0|-10.0|20.6|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 2||20.6|-10.0|
72332209|NCT04115748|144188884|SUPERIORITY||Difference in response rates|0.0|||||TWO_SIDED|95.0|-5.4|5.4|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 2||5.4|-5.4|
72332210|NCT04115748|144188884|SUPERIORITY||Difference in response rates|5.3|||||TWO_SIDED|95.0|-9.9|20.4|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||20.4|-9.9|
72332211|NCT04115748|144188884|SUPERIORITY||Difference in response rates|0.0|||||TWO_SIDED|95.0|-5.3|5.3|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||5.3|-5.3|
72332212|NCT04115748|144188884|SUPERIORITY||Difference in response rates|10.5|||||TWO_SIDED|95.0|-14.0|35.0|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 8||35.0|-14.0|
72332213|NCT04115748|144188884|SUPERIORITY||Difference in response rates|5.3|||||TWO_SIDED|95.0|-17.1|27.6|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 8||27.6|-17.1|
72332214|NCT04115748|144188884|SUPERIORITY||Difference in response rates|27.8|||||TWO_SIDED|95.0|1.7|53.9|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 12||53.9|1.7|
72332215|NCT04115748|144188884|SUPERIORITY||Difference in response rates|26.3|||||TWO_SIDED|95.0|1.3|51.4|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 12||51.4|1.3|
72332216|NCT04115748|144188884|SUPERIORITY||Difference in response rates|12.2|||||TWO_SIDED|95.0|-16.3|40.8|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||40.8|-16.3|
72332217|NCT04115748|144188884|SUPERIORITY||Difference in response rates|21.6|||||TWO_SIDED|95.0|-8.2|51.4|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||51.4|-8.2|
72332218|NCT04115748|144188892|SUPERIORITY||Difference in response rates|-10.5|||||TWO_SIDED|95.0|-46.3|25.2|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 2||25.2|-46.3|
72422818|NCT03502616|144356428|SUPERIORITY||LS mean difference|-0.26|STANDARD_ERROR_OF_MEAN|0.238||0.28|TWO_SIDED|95.0|-0.72|0.21|||Mixed Models Analysis|||Week 32: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.21|-0.72|0.2800
72422819|NCT03502616|144356428|SUPERIORITY||LS mean difference|-0.39|STANDARD_ERROR_OF_MEAN|0.243||0.1135|TWO_SIDED|95.0|-0.86|0.09|||Mixed Models Analysis|||Week 40: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.09|-0.86|0.1135
72422820|NCT03502616|144356428|SUPERIORITY||LS mean difference|-0.29|STANDARD_ERROR_OF_MEAN|0.247||0.2496|TWO_SIDED|95.0|-0.77|0.2|||Mixed Models Analysis|||Week 48: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.20|-0.77|0.2496
72422821|NCT03502616|144356429|SUPERIORITY||LS mean difference|-0.84|STANDARD_ERROR_OF_MEAN|0.191|<|0.0001|TWO_SIDED|95.0|-1.22|-0.47|||Mixed Models Analysis|||Week 2: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-0.47|-1.22|<0.0001
72422822|NCT03502616|144356429|SUPERIORITY||LS mean difference|-1.48|STANDARD_ERROR_OF_MEAN|0.21|<|0.0001|TWO_SIDED|95.0|-1.89|-1.07|||Mixed Models Analysis|||Week 4: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-1.07|-1.89|<0.0001
72422823|NCT03502616|144356429|SUPERIORITY||LS mean difference|-1.61|STANDARD_ERROR_OF_MEAN|0.228|<|0.0001|TWO_SIDED|95.0|-2.06|-1.16|||Mixed Models Analysis|||Week 8: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-1.16|-2.06|<0.0001
72332219|NCT04115748|144188892|SUPERIORITY||Difference in response rates|-8.8|||||TWO_SIDED|95.0|-45.3|27.7|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 2||27.7|-45.3|
72332220|NCT04115748|144188892|SUPERIORITY||Difference in response rates|11.8|||||TWO_SIDED|95.0|-22.1|45.8|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||45.8|-22.1|
72332221|NCT04115748|144188892|SUPERIORITY||Difference in response rates|19.4|||||TWO_SIDED|95.0|-15.6|54.5|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||54.5|-15.6|
72332222|NCT04115748|144188892|SUPERIORITY||Difference in response rates|10.5|||||TWO_SIDED|95.0|-26.0|47.0|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 8||47.0|-26.0|
72422824|NCT03502616|144356429|SUPERIORITY||LS mean difference|-1.87|STANDARD_ERROR_OF_MEAN|0.237|<|0.0001|TWO_SIDED|95.0|-2.34|-1.4|||Mixed Models Analysis|||Week 12: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-1.40|-2.34|<0.0001
72332223|NCT04115748|144188892|SUPERIORITY||Difference in response rates|10.5|||||TWO_SIDED|95.0|-26.0|47.0|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 8||47.0|-26.0|
72422825|NCT03502616|144356429|SUPERIORITY||LS mean difference|-1.72|STANDARD_ERROR_OF_MEAN|0.236|<|0.0001|TWO_SIDED|95.0|-2.18|-1.25|||Mixed Models Analysis|||Week 16: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-1.25|-2.18|<0.0001
72422826|NCT03502616|144356429|SUPERIORITY||LS mean difference|-0.51|STANDARD_ERROR_OF_MEAN|0.245||0.0385|TWO_SIDED|95.0|-0.99|-0.03|||Mixed Models Analysis|||Week 24: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-0.03|-0.99|0.0385
72422827|NCT03502616|144356429|SUPERIORITY||LS mean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.252||0.0463|TWO_SIDED|95.0|-1.0|-0.01|||Mixed Models Analysis|||Week 32: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-0.01|-1.00|0.0463
72332224|NCT04115748|144188892|SUPERIORITY||Difference in response rates|29.8|||||TWO_SIDED|95.0|-6.3|66.0|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 12||66.0|-6.3|
72332225|NCT04115748|144188892|SUPERIORITY||Difference in response rates|31.6|||||TWO_SIDED|95.0|-3.8|67.0|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 12||67.0|-3.8|
72332226|NCT04115748|144188892|SUPERIORITY||Difference in response rates|5.0|||||TWO_SIDED|95.0|-32.0|42.0|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||42.0|-32.0|
72422828|NCT03502616|144356429|SUPERIORITY||LS mean difference|-0.65|STANDARD_ERROR_OF_MEAN|0.257||0.0126|TWO_SIDED|95.0|-1.15|-0.14|||Mixed Models Analysis|||Week 40: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-0.14|-1.15|0.0126
72422829|NCT03502616|144356429|SUPERIORITY||LS mean difference|-0.56|STANDARD_ERROR_OF_MEAN|0.268||0.0372|TWO_SIDED|95.0|-1.09|-0.03|||Mixed Models Analysis|||Week 48: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-0.03|-1.09|0.0372
72422830|NCT03502616|144356430|SUPERIORITY||Difference in percentage|13.6|STANDARD_ERROR_OF_MEAN|3.53||0.0001|TWO_SIDED|95.0|6.68|20.52|||Cochran-Mantel-Haenszel|||Week 2: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||20.52|6.68|0.0001
72422831|NCT03502616|144356430|SUPERIORITY||Difference in percentage|28.79|STANDARD_ERROR_OF_MEAN|4.6|<|0.0001|TWO_SIDED|95.0|19.78|37.8|||Cochran-Mantel-Haenszel|||Week 4: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||37.80|19.78|<0.0001
72422832|NCT03502616|144356430|SUPERIORITY||Difference in percentage|33.31|STANDARD_ERROR_OF_MEAN|4.83|<|0.0001|TWO_SIDED|95.0|23.84|42.78|||Cochran-Mantel-Haenszel|||Week 8: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||42.78|23.84|<0.0001
72422833|NCT03502616|144356430|SUPERIORITY||Difference in percentage|36.37|STANDARD_ERROR_OF_MEAN|4.95|<|0.0001|TWO_SIDED|95.0|26.67|46.07|||Cochran-Mantel-Haenszel|||Week 12: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||46.07|26.67|<0.0001
72422834|NCT03502616|144356430|SUPERIORITY||Difference in percentage|36.34|STANDARD_ERROR_OF_MEAN|4.74|<|0.0001|TWO_SIDED|95.0|27.05|45.63|||Cochran-Mantel-Haenszel|||Week 16: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||45.63|27.05|<0.0001
72332227|NCT04115748|144188892|SUPERIORITY||Difference in response rates|39.2|||||TWO_SIDED|95.0|6.8|71.6|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||71.6|6.8|
72332228|NCT04115748|144188893|SUPERIORITY||Difference in response rates|0.0|||||TWO_SIDED|95.0|-24.8|24.8|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 2||24.8|-24.8|
72332229|NCT04115748|144188893|SUPERIORITY||Difference in response rates|0.6|||||TWO_SIDED|95.0|-24.9|26.0|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 2||26.0|-24.9|
72332230|NCT04115748|144188893|SUPERIORITY||Difference in response rates|-4.5|||||TWO_SIDED|95.0|-30.5|21.5|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||21.5|-30.5|
72332231|NCT04115748|144188893|SUPERIORITY||Difference in response rates|12.8|||||TWO_SIDED|95.0|-18.4|44.0|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||44.0|-18.4|
72422835|NCT03502616|144356430|SUPERIORITY||Difference in percentage|5.6|STANDARD_ERROR_OF_MEAN|5.99||0.3498|TWO_SIDED|95.0|-6.14|17.35|||Cochran-Mantel-Haenszel|||Week 24: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||17.35|-6.14|0.3498
72332232|NCT04115748|144188893|SUPERIORITY||Difference in response rates|21.1|||||TWO_SIDED|95.0|-14.1|56.3|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 8||56.3|-14.1|
72332233|NCT04115748|144188893|SUPERIORITY||Difference in response rates|0.0|||||TWO_SIDED|95.0|-33.3|33.3|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 8||33.3|-33.3|
72332234|NCT04115748|144188893|SUPERIORITY||Difference in response rates|34.5|||||TWO_SIDED|95.0|-0.3|69.3|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 12||69.3|-0.3|
72332235|NCT04115748|144188893|SUPERIORITY||Difference in response rates|21.1|||||TWO_SIDED|95.0|-13.0|55.1|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 12||55.1|-13.0|
72332236|NCT04115748|144188893|SUPERIORITY||Difference in response rates|24.4|||||TWO_SIDED|95.0|-9.7|58.6|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||58.6|-9.7|
72332237|NCT04115748|144188893|SUPERIORITY||Difference in response rates|32.6|||||TWO_SIDED|95.0|-1.0|66.2|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||66.2|-1.0|
72332238|NCT04115748|144188895|SUPERIORITY||Difference in response rates|-15.8|||||TWO_SIDED|95.0|-47.6|16.0|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 2||16.0|-47.6|
72332239|NCT04115748|144188895|SUPERIORITY||Difference in response rates|-20.5|||||TWO_SIDED|95.0|-51.3|10.4|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 2||10.4|-51.3|
72332240|NCT04115748|144188895|SUPERIORITY||Difference in response rates|6.6|||||TWO_SIDED|95.0|-26.8|39.9|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||39.9|-26.8|
72332241|NCT04115748|144188895|SUPERIORITY||Difference in response rates|13.9|||||TWO_SIDED|95.0|-20.8|48.6|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||48.6|-20.8|
72332242|NCT04115748|144188895|SUPERIORITY||Difference in response rates|15.8|||||TWO_SIDED|95.0|-20.7|52.3|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 8||52.3|-20.7|
72332243|NCT04115748|144188895|SUPERIORITY||Difference in response rates|5.3|||||TWO_SIDED|95.0|-31.0|41.6|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 8||41.6|-31.0|
72332244|NCT04115748|144188895|SUPERIORITY||Difference in response rates|24.3|||||TWO_SIDED|95.0|-12.4|60.9|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 12||60.9|-12.4|
72332245|NCT04115748|144188895|SUPERIORITY||Difference in response rates|21.1|||||TWO_SIDED|95.0|-15.2|57.4|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 12||57.4|-15.2|
72332246|NCT04115748|144188895|SUPERIORITY||Difference in response rates|4.4|||||TWO_SIDED|95.0|-32.3|41.2|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||41.2|-32.3|
72332247|NCT04115748|144188895|SUPERIORITY||Difference in response rates|23.2|||||TWO_SIDED|95.0|-12.5|58.8|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||58.8|-12.5|
72332248|NCT04115748|144188896|SUPERIORITY||Difference in response rates|0.0|||||TWO_SIDED|95.0|-19.5|19.5|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 2||19.5|-19.5|
72332249|NCT04115748|144188896|SUPERIORITY||Difference in response rates|-5.3|||||TWO_SIDED|95.0|-20.7|10.2|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 2||10.2|-20.7|
72332250|NCT04115748|144188896|SUPERIORITY||Difference in response rates|0.3|||||TWO_SIDED|95.0|-18.7|19.3|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||19.3|-18.7|
72332251|NCT04115748|144188896|SUPERIORITY||Difference in response rates|0.6|||||TWO_SIDED|95.0|-19.0|20.1|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||20.1|-19.0|
72332252|NCT04115748|144188896|SUPERIORITY||Difference in response rates|0.0|||||TWO_SIDED|95.0|-24.8|24.8|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 8||24.8|-24.8|
72422836|NCT03502616|144356430|SUPERIORITY||Difference in percentage|-2.4|STANDARD_ERROR_OF_MEAN|5.89||0.6835|TWO_SIDED|95.0|-13.96|9.15|||Cochran-Mantel-Haenszel|||Week 32: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||9.15|-13.96|0.6835
72332253|NCT04115748|144188896|SUPERIORITY||Difference in response rates|-5.3|||||TWO_SIDED|95.0|-27.6|17.1|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 8||17.1|-27.6|
72332254|NCT04115748|144188896|SUPERIORITY||Difference in response rates|17.0|||||TWO_SIDED|95.0|-10.1|44.0|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 12||44.0|-10.1|
72332255|NCT04115748|144188896|SUPERIORITY||Difference in response rates|26.3|||||TWO_SIDED|95.0|-2.1|54.8|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 12||54.8|-2.1|
72332256|NCT04115748|144188896|SUPERIORITY||Difference in response rates|6.7|||||TWO_SIDED|95.0|-20.3|33.6|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||33.6|-20.3|
72332257|NCT04115748|144188896|SUPERIORITY||Difference in response rates|11.1|||||TWO_SIDED|95.0|-16.6|38.7|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||38.7|-16.6|
72332258|NCT04115748|144188898|SUPERIORITY||Difference in response rates|0.0|||||TWO_SIDED|95.0|-34.8|34.8|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 2||34.8|-34.8|
72332259|NCT04115748|144188898|SUPERIORITY||Difference in response rates|-14.9|||||TWO_SIDED|95.0|-47.4|17.6|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 2||17.6|-47.4|
72332260|NCT04115748|144188898|SUPERIORITY||Difference in response rates|27.9|||||TWO_SIDED|95.0|-7.2|63.0|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||63.0|-7.2|
72332261|NCT04115748|144188898|SUPERIORITY||Difference in response rates|8.9|||||TWO_SIDED|95.0|-26.6|44.3|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||44.3|-26.6|
72332262|NCT04115748|144188898|SUPERIORITY||Difference in response rates|21.1|||||TWO_SIDED|95.0|-13.0|55.1|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 8||55.1|-13.0|
72332263|NCT04115748|144188898|SUPERIORITY||Difference in response rates|-10.5|||||TWO_SIDED|95.0|-47.4|26.3|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 8||26.3|-47.4|
72332264|NCT04115748|144188898|SUPERIORITY||Difference in response rates|24.9|||||TWO_SIDED|95.0|-11.1|60.8|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 12||60.8|-11.1|
72332265|NCT04115748|144188898|SUPERIORITY||Difference in response rates|21.1|||||TWO_SIDED|95.0|-14.9|57.0|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 12||57.0|-14.9|
72332266|NCT04115748|144188898|SUPERIORITY||Difference in response rates|43.9|||||TWO_SIDED|95.0|12.4|75.4|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||75.4|12.4|
72332267|NCT04115748|144188898|SUPERIORITY||Difference in response rates|12.9|||||TWO_SIDED|95.0|-23.4|49.1|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||49.1|-23.4|
72332268|NCT04115748|144188900|SUPERIORITY||Difference in response rates|37.5|||||TWO_SIDED|95.0|-14.8|89.8|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||89.8|-14.8|
72332269|NCT04115748|144188900|SUPERIORITY||Difference in response rates|40.0|||||TWO_SIDED|95.0|-25.4|100.0|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||100.0|-25.4|
72332270|NCT04115748|144188900|SUPERIORITY||Difference in response rates|-25.0|||||TWO_SIDED|95.0|-100.0|51.2|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 8||51.2|-100.0|
72332271|NCT04115748|144188900|SUPERIORITY||Difference in response rates|-10.0|||||TWO_SIDED|95.0|-97.7|77.7|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 8||77.7|-97.7|
72332272|NCT04115748|144188900|SUPERIORITY||Difference in response rates|7.1|||||TWO_SIDED|95.0|-73.7|88.0|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 12||88.0|-73.7|
72332273|NCT04115748|144188900|SUPERIORITY||Difference in response rates|-10.0|||||TWO_SIDED|95.0|-97.7|77.7|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 12||77.7|-97.7|
72422837|NCT03502616|144356430|SUPERIORITY||Difference in percentage|-1.75|STANDARD_ERROR_OF_MEAN|5.98||0.7704|TWO_SIDED|95.0|-13.47|9.98|||Cochran-Mantel-Haenszel|||Week 40: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||9.98|-13.47|0.7704
72332274|NCT04115748|144188900|SUPERIORITY||Difference in response rates|37.5|||||TWO_SIDED|95.0|-35.3|100.0|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||100.0|-35.3|
72332275|NCT04115748|144188900|SUPERIORITY||Difference in response rates|15.0|||||TWO_SIDED|95.0|-67.9|97.9|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||97.9|-67.9|
72332276|NCT04115748|144188901|SUPERIORITY||Difference in response rates|12.5|||||TWO_SIDED|95.0|-29.2|54.2|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||54.2|-29.2|
72332277|NCT04115748|144188901|SUPERIORITY||Difference in response rates|20.0|||||TWO_SIDED|95.0|-37.6|77.6|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||77.6|-37.6|
72332278|NCT04115748|144188901|SUPERIORITY||Difference in response rates|25.0|||||TWO_SIDED|95.0|-23.8|73.8|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 8||73.8|-23.8|
72332279|NCT04115748|144188901|SUPERIORITY||Difference in response rates|40.0|||||TWO_SIDED|95.0|-25.4|100.0|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 8||100.0|-25.4|
72422838|NCT03502616|144356430|SUPERIORITY||Difference in percentage|-1.13|STANDARD_ERROR_OF_MEAN|5.95||0.8492|TWO_SIDED|95.0|-12.8|10.53|||Cochran-Mantel-Haenszel|||Week 48: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||10.53|-12.80|0.8492
72422839|NCT03502616|144356431|SUPERIORITY||Difference in percentage|2.24|STANDARD_ERROR_OF_MEAN|1.63||0.1692|TWO_SIDED|95.0|-0.95|5.43|||Cochran-Mantel-Haenszel|||Week 2: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||5.43|-0.95|0.1692
72422840|NCT03502616|144356431|SUPERIORITY||Difference in percentage|4.46|STANDARD_ERROR_OF_MEAN|2.04||0.0289|TWO_SIDED|95.0|0.46|8.46|||Cochran-Mantel-Haenszel|||Week 4: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||8.46|0.46|0.0289
72422841|NCT03502616|144356431|SUPERIORITY||Difference in percentage|6.02|STANDARD_ERROR_OF_MEAN|2.59||0.0199|TWO_SIDED|95.0|0.95|11.09|||Cochran-Mantel-Haenszel|||Week 8: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||11.09|0.95|0.0199
72422842|NCT03502616|144356431|SUPERIORITY||Difference in percentage|12.03|STANDARD_ERROR_OF_MEAN|3.46||0.0005|TWO_SIDED|95.0|5.26|18.81|||Difference in percentage|||Week 12: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||18.81|5.26|0.0005
72422843|NCT03502616|144356431|SUPERIORITY||Difference in percentage|12.05|STANDARD_ERROR_OF_MEAN|3.45||0.0005|TWO_SIDED|95.0|5.29|18.8|||Cochran-Mantel-Haenszel|||Week 16: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||18.80|5.29|0.0005
72332280|NCT04115748|144188901|SUPERIORITY||Difference in response rates|42.9|||||TWO_SIDED|95.0|-13.4|99.2|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 12||99.2|-13.4|
72332281|NCT04115748|144188901|SUPERIORITY||Difference in response rates|40.0|||||TWO_SIDED|95.0|-25.4|100.0|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 12||100.0|-25.4|
72332282|NCT04115748|144188901|SUPERIORITY||Difference in response rates|37.5|||||TWO_SIDED|95.0|-35.3|100.0|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||100.0|-35.3|
72332283|NCT04115748|144188901|SUPERIORITY||Difference in response rates|-5.0|||||TWO_SIDED|95.0|-82.5|72.5|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||72.5|-82.5|
72332284|NCT04115748|144188902|SUPERIORITY||Difference in response rates|0.0|||||TWO_SIDED|95.0|-18.8|18.8|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||18.8|-18.8|
72332285|NCT04115748|144188902|SUPERIORITY||Difference in response rates|0.0|||||TWO_SIDED|95.0|-22.5|22.5|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||22.5|-22.5|
72332286|NCT04115748|144188902|SUPERIORITY||Difference in response rates|12.5|||||TWO_SIDED|95.0|-29.2|54.2|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 8||54.2|-29.2|
72332287|NCT04115748|144188902|SUPERIORITY||Difference in response rates|0.0|||||TWO_SIDED|95.0|-22.5|22.5|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 8||22.5|-22.5|
72332288|NCT04115748|144188902|SUPERIORITY||Difference in response rates|14.3|||||TWO_SIDED|95.0|-31.3|59.9|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 12||59.9|-31.3|
72332289|NCT04115748|144188902|SUPERIORITY||Difference in response rates|20.0|||||TWO_SIDED|95.0|-37.6|77.6|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 12||77.6|-37.6|
72332290|NCT04115748|144188902|SUPERIORITY||Difference in response rates|25.0|||||TWO_SIDED|95.0|-23.8|73.8|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||73.8|-23.8|
72332291|NCT04115748|144188902|SUPERIORITY||Difference in response rates|20.0|||||TWO_SIDED|95.0|-37.6|77.6|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||77.6|-37.6|
72332292|NCT04115748|144188903|SUPERIORITY||Difference in response rates|0.0|||||TWO_SIDED|95.0|-18.8|18.8|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||18.8|-18.8|
72422844|NCT03502616|144356431|SUPERIORITY||Difference in percentage|10.03|STANDARD_ERROR_OF_MEAN|4.49||0.0253|TWO_SIDED|95.0|1.24|18.83|||Cochran-Mantel-Haenszel|||Week 24: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||18.83|1.24|0.0253
72332293|NCT04115748|144188903|SUPERIORITY||Difference in response rates|0.0|||||TWO_SIDED|95.0|-22.5|22.5|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||22.5|-22.5|
72332294|NCT04115748|144188903|SUPERIORITY||Difference in response rates|0.0|||||TWO_SIDED|95.0|-18.8|18.8|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 8||18.8|-18.8|
72332295|NCT04115748|144188903|SUPERIORITY||Difference in response rates|0.0|||||TWO_SIDED|95.0|-22.5|22.5|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 8||22.5|-22.5|
72332296|NCT04115748|144188903|SUPERIORITY||Difference in response rates|14.3|||||TWO_SIDED|95.0|-31.3|59.9|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 12||59.9|-31.3|
72332297|NCT04115748|144188903|SUPERIORITY||Difference in response rates|0.0|||||TWO_SIDED|95.0|-22.5|22.5|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 12||22.5|-22.5|
72332298|NCT04115748|144188903|SUPERIORITY||Difference in response rates|12.5|||||TWO_SIDED|95.0|-29.2|54.2|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||54.2|-29.2|
72332299|NCT04115748|144188903|SUPERIORITY||Difference in response rates|20.0|||||TWO_SIDED|95.0|-37.6|77.6|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||77.6|-37.6|
72332300|NCT04115748|144188907|SUPERIORITY||LS Mean Treatment Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.104||0.94|TWO_SIDED|95.0|-0.22|0.2||P-value was calculated from mixed-effects model for repeated measures (MMRM) including treatment, visit (categorical), treatment by visit, stratification factors, baseline value as fixed effects, and participants being the random effect.|MMRM|||Week 2||0.20|-0.22|0.94
72332301|NCT04115748|144188907|SUPERIORITY||LS Mean Treatment Difference|0.03|STANDARD_ERROR_OF_MEAN|0.105||0.81|TWO_SIDED|95.0|-0.18|0.24||P-value was calculated from MMRM including treatment, visit (categorical), treatment by visit, stratification factors, baseline value as fixed effects, and participants being the random effect.|MMRM|||Week 2||0.24|-0.18|0.81
72332302|NCT04115748|144188907|SUPERIORITY||LS Mean Treatment Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.112||0.13|TWO_SIDED|95.0|-0.39|0.05||P-value was calculated from MMRM including treatment, visit (categorical), treatment by visit, stratification factors, baseline value as fixed effects, and participants being the random effect.|MMRM|||Week 4||0.05|-0.39|0.13
72332303|NCT04115748|144188907|SUPERIORITY||LS Mean Treatment Difference|-0.21|STANDARD_ERROR_OF_MEAN|0.113||0.073|TWO_SIDED|95.0|-0.43|0.02||P-value was calculated from MMRM including treatment, visit (categorical), treatment by visit, stratification factors, baseline value as fixed effects, and participants being the random effect.|MMRM|||Week 4||0.02|-0.43|0.073
72332304|NCT04115748|144188907|SUPERIORITY||LS Mean Treatment Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.124||0.083|TWO_SIDED|95.0|-0.46|0.03||P-value was calculated from MMRM including treatment, visit (categorical), treatment by visit, stratification factors, baseline value as fixed effects, and participants being the random effect.|MMRM|||Week 8||0.03|-0.46|0.083
72332305|NCT04115748|144188907|SUPERIORITY||LS Mean Treatment Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.124||0.28|TWO_SIDED|95.0|-0.38|0.11||P-value was calculated from MMRM including treatment, visit (categorical), treatment by visit, stratification factors, baseline value as fixed effects, and participants being the random effect.|MMRM|||Week 8||0.11|-0.38|0.28
72332306|NCT04115748|144188907|SUPERIORITY||LS Mean Treatment Difference|-0.28|STANDARD_ERROR_OF_MEAN|0.13||0.038|TWO_SIDED|95.0|-0.54|-0.02||P-value was calculated from MMRM including treatment, visit (categorical), treatment by visit, stratification factors, baseline value as fixed effects, and participants being the random effect.|MMRM|||Week 12||-0.02|-0.54|0.038
72332307|NCT04115748|144188907|SUPERIORITY||LS Mean Treatment Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.129||0.25|TWO_SIDED|95.0|-0.41|0.11||P-value was calculated from MMRM including treatment, visit (categorical), treatment by visit, stratification factors, baseline value as fixed effects, and participants being the random effect.|MMRM|||Week 12||0.11|-0.41|0.25
72332308|NCT04115748|144188907|SUPERIORITY||LS Mean Treatment Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.139||0.41|TWO_SIDED|95.0|-0.39|0.16||P-value was calculated from MMRM including treatment, visit (categorical), treatment by visit, stratification factors, baseline value as fixed effects, and participants being the random effect.|MMRM|||Week 16||0.16|-0.39|0.41
72332309|NCT04115748|144188907|SUPERIORITY||LS Mean Treatment Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.138||0.26|TWO_SIDED|95.0|-0.43|0.12||P-value was calculated from MMRM including treatment, visit (categorical), treatment by visit, stratification factors, baseline value as fixed effects, and participants being the random effect.|MMRM|||Week 16||0.12|-0.43|0.26
72332310|NCT04115748|144188908|SUPERIORITY||LS Mean Treatment Difference|3.4|STANDARD_ERROR_OF_MEAN|2.26||0.14|TWO_SIDED|95.0|-1.1|7.9||P-value was calculated from MMRM including treatment, visit (categorical), treatment by visit, stratification factors, baseline value as fixed effects, and participants being the random effect.|MMRM|||Week 4||7.9|-1.1|0.14
72332311|NCT04115748|144188908|SUPERIORITY||LS Mean Treatment Difference|3.1|STANDARD_ERROR_OF_MEAN|2.3||0.18|TWO_SIDED|95.0|-1.5|7.7||P-value was calculated from MMRM including treatment, visit (categorical), treatment by visit, stratification factors, baseline value as fixed effects, and participants being the random effect.|MMRM|||Week 4||7.7|-1.5|0.18
72332312|NCT04115748|144188908|SUPERIORITY||LS Mean Treatment Difference|3.7|STANDARD_ERROR_OF_MEAN|2.53||0.15|TWO_SIDED|95.0|-1.4|8.7||P-value was calculated from MMRM including treatment, visit (categorical), treatment by visit, stratification factors, baseline value as fixed effects, and participants being the random effect.|MMRM|||Week 16||8.7|-1.4|0.15
72332313|NCT04115748|144188908|SUPERIORITY||LS Mean Treatment Difference|4.8|STANDARD_ERROR_OF_MEAN|2.54||0.062|TWO_SIDED|95.0|-0.3|9.9||P-value was calculated from MMRM including treatment, visit (categorical), treatment by visit, stratification factors, baseline value as fixed effects, and participants being the random effect.|MMRM|||Week 16||9.9|-0.3|0.062
72332314|NCT04115748|144188910|SUPERIORITY||LS Mean Treatment Difference|5.3|STANDARD_ERROR_OF_MEAN|1.68||0.003|TWO_SIDED|95.0|1.9|8.6||P-value was calculated from MMRM including treatment, visit (categorical), treatment by visit, stratification factors, baseline value as fixed effects, and participants being the random effect.|MMRM|||Week 4||8.6|1.9|0.003
72332315|NCT04115748|144188910|SUPERIORITY||LS Mean Treatment Difference|4.9|STANDARD_ERROR_OF_MEAN|1.71||0.006|TWO_SIDED|95.0|1.5|8.3||P-value was calculated from MMRM including treatment, visit (categorical), treatment by visit, stratification factors, baseline value as fixed effects, and participants being the random effect.|MMRM|||Week 4||8.3|1.5|0.006
72332316|NCT04115748|144188910|SUPERIORITY||LS Mean Treatment Difference|3.8|STANDARD_ERROR_OF_MEAN|2.09||0.076|TWO_SIDED|95.0|-0.4|8.0||P-value was calculated from MMRM including treatment, visit (categorical), treatment by visit, stratification factors, baseline value as fixed effects, and participants being the random effect.|MMRM|||Week 16||8.0|-0.4|0.076
72332317|NCT04115748|144188910|SUPERIORITY||LS Mean Treatment Difference|3.5|STANDARD_ERROR_OF_MEAN|2.1||0.1|TWO_SIDED|95.0|-0.7|7.7||P-value was calculated from MMRM including treatment, visit (categorical), treatment by visit, stratification factors, baseline value as fixed effects, and participants being the random effect.|MMRM|||Week 16||7.7|-0.7|0.10
72332318|NCT00967694|144188914|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Mixed Models Analysis|||A linear mixed effects model was used to assess change in IOP over time using time-points as the primary independent variable with significance set at p \< 0.05. Power calculations showed that 20 subjects would allow detection of a 2.8-mmHg difference in IOP between any two time-points with 80% power assuming a standard deviation of 3.5 mmHg for IOP and a correlation between two time- points of 0.25||||>0.05
72332319|NCT01626118|144188957|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|317.612|STANDARD_ERROR_OF_MEAN|149.6694||0.034|TWO_SIDED|95.0|23.297|611.926|||ANCOVA|||The p value was obtained from an analysis of covariance (ANCOVA) model that included treatment effect as the factor and baseline pain intensity as the covariate. This was the primary analysis of the primary efficacy parameter.||611.926|23.297|0.034
72332320|NCT01626118|144188957|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|342.132|STANDARD_ERROR_OF_MEAN|150.0397||0.023|TWO_SIDED|95.0|47.09|637.175|||ANCOVA|||The p value was obtained from an analysis of covariance (ANCOVA) model that included treatment effect as the factor and baseline pain intensity as the covariate. This was the primary analysis of the primary efficacy parameter.||637.175|47.090|0.023
72332321|NCT01626118|144188957|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|61.972|STANDARD_ERROR_OF_MEAN|150.2717||0.68|TWO_SIDED|95.0|-233.527|357.471|||ANCOVA|||The p value was obtained from an analysis of covariance (ANCOVA) model that included treatment effect as the factor and baseline pain intensity as the covariate. This was the primary analysis of the primary efficacy parameter.||357.471|-233.527|0.680
72332322|NCT01626118|144188957|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|503.008|STANDARD_ERROR_OF_MEAN|102.3149|<|0.001|TWO_SIDED|95.0|301.93|704.086|||Mixed Models Analysis|||"The p value was obtained from a mixed-model repeated-measure (MMRM) model that used all available data from all subjects to derive an estimate of pain intensity scores for subjects following study withdrawal, rather than imputing a score for individual subjects. The MMRM analysis was a sensitivity analysis of the primary efficacy parameter."||704.086|301.930|<0.001
72332323|NCT01626118|144188957|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|511.357|STANDARD_ERROR_OF_MEAN|102.5851|<|0.001|TWO_SIDED|95.0|309.749|712.965|||Mixed Models Analysis|||"The p value was obtained from a mixed-model repeated-measure (MMRM) model that used all available data from all subjects to derive an estimate of pain intensity scores for subjects following study withdrawal, rather than imputing a score for individual subjects. The MMRM analysis was a sensitivity analysis of the primary efficacy parameter."||712.965|309.749|<0.001
72332324|NCT01626118|144188957|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|341.232|STANDARD_ERROR_OF_MEAN|102.7761|<|0.001|TWO_SIDED|95.0|139.249|543.215|||Mixed Models Analysis|||"The p value was obtained from a mixed-model repeated-measure (MMRM) model that used all available data from all subjects to derive an estimate of pain intensity scores for subjects following study withdrawal, rather than imputing a score for individual subjects. The MMRM analysis was a sensitivity analysis of the primary efficacy parameter."||543.215|139.249|<0.001
72332325|NCT01626118|144188958|SUPERIORITY_OR_OTHER|||||||0.191|||||||t-test, 2 sided|||||||0.191
72332326|NCT01626118|144188958|SUPERIORITY_OR_OTHER|||||||0.108|||||||t-test, 2 sided|||||||0.108
72332327|NCT01626118|144188958|SUPERIORITY_OR_OTHER|||||||0.461|||||||t-test, 2 sided|||||||0.461
72332328|NCT01626118|144188959|SUPERIORITY_OR_OTHER|||||||0.079|||||||t-test, 2 sided|||||||0.079
72332329|NCT01626118|144188959|SUPERIORITY_OR_OTHER|||||||0.041|||||||t-test, 2 sided|||||||0.041
72332330|NCT01626118|144188959|SUPERIORITY_OR_OTHER|||||||0.458|||||||t-test, 2 sided|||||||0.458
72332331|NCT01626118|144188960|SUPERIORITY_OR_OTHER|||||||0.02|||||||t-test, 2 sided|||||||0.020
72332332|NCT01626118|144188960|SUPERIORITY_OR_OTHER|||||||0.021|||||||t-test, 2 sided|||||||0.021
72332333|NCT01626118|144188960|SUPERIORITY_OR_OTHER|||||||0.441|||||||t-test, 2 sided|||||||0.441
72332334|NCT01626118|144188961|SUPERIORITY_OR_OTHER|||||||0.141|||||||t-test, 2 sided|||||||0.141
72332335|NCT01626118|144188961|SUPERIORITY_OR_OTHER|||||||0.071|||||||t-test, 2 sided|||||||0.071
72332336|NCT01626118|144188961|SUPERIORITY_OR_OTHER|||||||0.716|||||||t-test, 2 sided|||||||0.716
72422845|NCT03502616|144356431|SUPERIORITY||Difference in percentage|7.93|STANDARD_ERROR_OF_MEAN|4.75||0.095|TWO_SIDED|95.0|-1.38|17.24|||Cochran-Mantel-Haenszel|||Week 32: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||17.24|-1.38|0.0950
72422846|NCT03502616|144356431|SUPERIORITY||Difference in percentage|7.21|STANDARD_ERROR_OF_MEAN|4.86||0.1377|TWO_SIDED|95.0|-2.31|16.73|||Cochran-Mantel-Haenszel|||Week 40: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||16.73|-2.31|0.1377
72422847|NCT03502616|144356431|SUPERIORITY||Difference in percentage|5.68|STANDARD_ERROR_OF_MEAN|4.91||0.2472|TWO_SIDED|95.0|-3.94|15.3|||Cochran-Mantel-Haenszel|||Week 48: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||15.30|-3.94|0.2472
72422848|NCT03502616|144356432|SUPERIORITY||LS mean difference|-0.73|STANDARD_ERROR_OF_MEAN|0.163|<|0.0001|TWO_SIDED|95.0|-1.05|-0.41|||Mixed Models Analysis|||Week 2: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-0.41|-1.05|<0.0001
72422849|NCT03502616|144356432|SUPERIORITY||LS mean difference|-1.28|STANDARD_ERROR_OF_MEAN|0.187|<|0.0001|TWO_SIDED|95.0|-1.65|-0.91|||Mixed Models Analysis|||Week 4: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-0.91|-1.65|<0.0001
72422850|NCT03502616|144356432|SUPERIORITY||LS mean difference|-1.5|STANDARD_ERROR_OF_MEAN|0.21|<|0.0001|TWO_SIDED|95.0|-1.92|-1.09|||Mixed Models Analysis|||Week 8: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-1.09|-1.92|<0.0001
72422851|NCT03502616|144356432|SUPERIORITY||LS mean difference|-1.68|STANDARD_ERROR_OF_MEAN|0.221|<|0.0001|TWO_SIDED|95.0|-2.11|-1.24|||Mixed Models Analysis|||Week 12: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-1.24|-2.11|<0.0001
72422852|NCT03502616|144356432|SUPERIORITY||LS mean difference|-1.44|STANDARD_ERROR_OF_MEAN|0.223|<|0.0001|TWO_SIDED|95.0|-1.88|-1.0|||Mixed Models Analysis|||Week 16: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-1.00|-1.88|<0.0001
72422853|NCT03502616|144356432|SUPERIORITY||LS mean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.235||0.088|TWO_SIDED|95.0|-0.86|0.06|||Mixed Models Analysis|||Week 24: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.06|-0.86|0.0880
72332337|NCT01626118|144188962|SUPERIORITY_OR_OTHER|||||||0.049|||||||t-test, 2 sided|||||||0.049
72332338|NCT01626118|144188962|SUPERIORITY_OR_OTHER|||||||0.02|||||||t-test, 2 sided|||||||0.020
72332339|NCT01626118|144188962|SUPERIORITY_OR_OTHER|||||||0.593|||||||t-test, 2 sided|||||||0.593
72422854|NCT03502616|144356432|SUPERIORITY||LS mean difference|-0.41|STANDARD_ERROR_OF_MEAN|0.241||0.0921|TWO_SIDED|95.0|-0.88|0.07|||Mixed Models Analysis|||Week 32: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.07|-0.88|0.0921
72332340|NCT01626118|144188963|SUPERIORITY_OR_OTHER|||||||0.021|||||||t-test, 2 sided|||||||0.021
72332341|NCT01626118|144188963|SUPERIORITY_OR_OTHER|||||||0.012|||||||t-test, 2 sided|||||||0.012
72332342|NCT01626118|144188963|SUPERIORITY_OR_OTHER|||||||0.447|||||||t-test, 2 sided|||||||0.447
72332343|NCT01626118|144188964|SUPERIORITY_OR_OTHER|||||||0.036|||||||t-test, 2 sided|||||||0.036
72332344|NCT01626118|144188964|SUPERIORITY_OR_OTHER|||||||0.017|||||||t-test, 2 sided|||||||0.017
72332345|NCT01626118|144188964|SUPERIORITY_OR_OTHER|||||||0.577|||||||t-test, 2 sided|||||||0.577
72332346|NCT04590404|144188995|SUPERIORITY||Odds Ratio (OR)|1.18||||0.461|TWO_SIDED|95.0|0.76|1.82|||Regression, Logistic|Adjusted for arm, randomization strata (cigarettes/day (CPD), insurance category, cardiac admission, NMR category), \& plan to quit after discharge||The primary outcome was biochemically-verified self-reported 7-day point prevalence abstinence (7dPPA) at 6 months. We modeled outcomes using logistic regression adjusted for randomization stratification factors and plan to quit (stay quit vs. try).||1.82|0.76|0.461
72332347|NCT00344318|144189026|NON_INFERIORITY_OR_EQUIVALENCE|Standardized asymptotic 95% confidence interval (CI) for the difference \[Synflorix™ minus Prevenar™\] in terms of percentages of subjects reporting rectal fever \>39.0°C after Dose 1 was computed.|Difference in percentage|2.17|||||TWO_SIDED|95.0|-1.51|4.88||||||Analysis aimed to demonstrate that Synflorix™ vaccine administered as a 3-dose primary vaccination course (either at 6-10-14 weeks or at 2-4-6 months of age), is non-inferior to Prevenar™ in terms of the incidence of post-immunization rectal fever \>39.0°C, when co-administered with Tritanrix™-HepB/Hiberix™ and Polio Sabin™ or Poliorix™ vaccines.||4.88|-1.51|
72332348|NCT00344318|144189026|NON_INFERIORITY_OR_EQUIVALENCE|Towards this, standardized asymptotic 95% confidence interval (CI) for the difference \[Synflorix™ minus Prevenar™\] in terms of percentages of subjects reporting rectal fever \>39.0°C after Dose 2 was computed|Difference in percentage|-1.48||||||95.0|-6.05|1.92||||||Analysis aimed to demonstrate that Synflorix™ vaccine administered as a 3-dose primary vaccination course (either at 6-10-14 weeks or at 2-4-6 months of age), is non-inferior to Prevenar™ in terms of the incidence of post-immunization rectal fever \>39.0°C, when co-administered with Tritanrix™-HepB/Hiberix™ and Polio Sabin™ or Poliorix™ vaccines.||1.92|-6.05|
72332349|NCT00344318|144189026|NON_INFERIORITY_OR_EQUIVALENCE|Towards this, standardized asymptotic 95% confidence interval (CI) for the difference \[Synflorix™ minus Prevenar™\] in terms of percentages of subjects reporting rectal fever \>39.0°C after Dose 3 was computed.|Difference in percentage|3.05|||||TWO_SIDED|95.0|-1.02|6.19||||||Analysis aimed to demonstrate that Synflorix™ vaccine administered as a 3-dose primary vaccination course (either at 6-10-14 weeks or at 2-4-6 months of age), is non-inferior to Prevenar™ in terms of the incidence of post-immunization rectal fever \>39.0°C, when co-administered with Tritanrix™-HepB/Hiberix™ and Polio Sabin™ or Poliorix™ vaccines.||6.19|-1.02|
72332350|NCT00344318|144189026|NON_INFERIORITY_OR_EQUIVALENCE|Standardized asymptotic 95% confidence interval (CI) for the difference \[Synflorix™ minus Prevenar™\] in terms of percentages of subjects reporting rectal fever \>39.0°C across doses was computed.|Difference in percentage|3.13|||||TWO_SIDED|95.0|-2.65|8.01||||||Analysis aimed to demonstrate that Synflorix™ vaccine administered as a 3-dose primary vaccination course (either at 6-10-14 weeks or at 2-4-6 months of age), is non-inferior to Prevenar™ in terms of the incidence of post-immunization rectal fever \>39.0°C, when co-administered with Tritanrix™-HepB/Hiberix™ and Polio Sabin™ or Poliorix™ vaccines.||8.01|-2.65|
72422855|NCT03502616|144356432|SUPERIORITY||LS mean difference|-0.46|STANDARD_ERROR_OF_MEAN|0.243||0.0597|TWO_SIDED|95.0|-0.94|0.02|||Mixed Models Analysis|||Week 40: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.02|-0.94|0.0597
72332351|NCT04113018|144189146|SUPERIORITY||Response rate|0.5385||||0.375|TWO_SIDED|95.0|0.3718|0.6991|||Fisher Exact||Confidence interval estimated using the Clopper Pearson method.|A minimax 2-stage design was used to test the hypothesis that the CR+ rate less than or equal to 50%. Twenty-three evaluable subjects were enrolled in the first stage, followed by an additional 16 subjects for a total of 39 subjects. This design provided 90% power to detect a difference of 20% under the alternative hypothesis, assuming a one-sided alpha=0.10 significance level. If at least 24 of 39 participants had achieved CR or better to induction, the null hypothesis would have been rejected.||0.6991|0.3718|0.375
72332352|NCT04113018|144189153|OTHER|Estimation only|Rate|0.0513|||||TWO_SIDED|95.0|0.0063|0.1732|||||Confidence interval estimated using the Clopper Pearson method.|||0.1732|0.0063|
72332353|NCT04113018|144189154|OTHER|Estimation only.|Rate|0.0256|||||TWO_SIDED|95.0|0.0006|0.1348|||||Confidence interval estimated using the Clopper Pearson method.|||0.1348|0.0006|
72332354|NCT06099223|144189175|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
72332355|NCT06099223|144189176|SUPERIORITY|||||||0.029|TWO_SIDED|95.0|||||t-test, 2 sided|||||||0.029
72332356|NCT06099223|144189178|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
72332357|NCT06099223|144189179|SUPERIORITY|||||||0.38|||||||t-test, 2 sided|||||||0.38
72332358|NCT06099223|144189180|SUPERIORITY|||||||0.61|||||||t-test, 2 sided|||||||0.61
72332359|NCT06099223|144189181|SUPERIORITY|||||||0.37|||||||Chi-squared|||||||0.37
72332360|NCT06099223|144189182|SUPERIORITY|||||||0.11|||||||Fisher Exact|||||||0.11
72332361|NCT06099223|144189183|SUPERIORITY|||||||0.37|||||||Wilcoxon (Mann-Whitney)|||||||0.37
72332362|NCT06099223|144189184|SUPERIORITY|||||||0.38|||||||Wilcoxon (Mann-Whitney)|||||||0.38
72332363|NCT06099223|144189185|SUPERIORITY|||||||0.087|||||||t-test, 2 sided|||||||0.087
72332364|NCT06099223|144189186|SUPERIORITY|||||||0.147|||||||t-test, 2 sided|||||||0.147
72332365|NCT06099223|144189187|SUPERIORITY|||||||0.098|||||||t-test, 2 sided|||||||0.098
72332366|NCT06099223|144189188|SUPERIORITY|||||||0.41|||||||Chi-squared|||||||0.41
72332367|NCT06099223|144189189|SUPERIORITY|||||||0.79|||||||Chi-squared|||||||0.79
72332368|NCT06099223|144189190|SUPERIORITY|||||||0.58|||||||Chi-squared|||||||0.58
72332369|NCT06099223|144189192|SUPERIORITY|||||||1|||||||Chi-squared|||||||1.00
72332370|NCT06099223|144189193|SUPERIORITY|||||||0.919|||||||ANCOVA|||||||0.919
72332371|NCT02488135|144189200|NON_INFERIORITY|An a priori sample size was calculated using a non-inferiority limit (d) set at 25%, significance level (α) of 5% and power of 80%. We assumed that success in each group would be 93% based on the literature examining anterior nasal packing in ideal conditions and considering our selection criteria in the Floseal® (Baxter, USA) population. Attrition was assumed to be 0% due to the short duration of treatment. This yielded 26 participants with 13 patients in each study arm.||||||1|||||||Fisher Exact|||||||1.000
72332372|NCT02488135|144189201|SUPERIORITY|||||||0.0022|||||||Wilcoxon (Mann-Whitney)|||Comparison between groups for pain during placement.||||0.0022
72332373|NCT02488135|144189201|SUPERIORITY|||||||0.0007|||||||Wilcoxon (Mann-Whitney)|||Comparison between groups for pain during treatment.||||0.0007
72422856|NCT03502616|144356432|SUPERIORITY||LS mean difference|-0.49|STANDARD_ERROR_OF_MEAN|0.25||0.0492|TWO_SIDED|95.0|-0.99|0.0|||Mixed Models Analysis|||Week 48: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-0.00|-0.99|0.0492
72422857|NCT03502616|144356433|SUPERIORITY||Difference in percentage|8.31|STANDARD_ERROR_OF_MEAN|3.29||0.0116|TWO_SIDED|95.0|1.86|14.77|||Cochran-Mantel-Haenszel|||Week 2: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||14.77|1.86|0.0116
72422858|NCT03502616|144356433|SUPERIORITY||Difference in percentage|22.74|STANDARD_ERROR_OF_MEAN|4.46|<|0.0001|TWO_SIDED|95.0|13.99|31.49|||Cochran-Mantel-Haenszel|||Week 4: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||31.49|13.99|<0.0001
72422859|NCT03502616|144356433|SUPERIORITY||Difference in percentage|28.87|STANDARD_ERROR_OF_MEAN|4.99|<|0.0001|TWO_SIDED|95.0|19.09|38.66|||Cochran-Mantel-Haenszel|||Week 8: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||38.66|19.09|<0.0001
72422860|NCT03502616|144356433|SUPERIORITY||Difference in percentage|31.93|STANDARD_ERROR_OF_MEAN|4.92|<|0.0001|TWO_SIDED|95.0|22.28|41.58|||Cochran-Mantel-Haenszel|||Week 12: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||41.58|22.28|<0.0001
72422861|NCT03502616|144356433|SUPERIORITY||Difference in percentage|25.28|STANDARD_ERROR_OF_MEAN|5.34|<|0.0001|TWO_SIDED|95.0|14.82|35.75|||Cochran-Mantel-Haenszel|||Week 16: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||35.75|14.82|<0.0001
72332374|NCT02488135|144189201|SUPERIORITY|||||||0.0021|||||||Wilcoxon (Mann-Whitney)|||Comparison between scores for pain during removal.||||0.0021
72422862|NCT03502616|144356433|SUPERIORITY||Difference in percentage|10.71|STANDARD_ERROR_OF_MEAN|5.88||0.0683|TWO_SIDED|95.0|-0.8|22.23|||Cochran-Mantel-Haenszel|||Week 24: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||22.23|-0.80|0.0683
72422863|NCT03502616|144356433|SUPERIORITY||Difference in percentage|10.05|STANDARD_ERROR_OF_MEAN|5.94||0.0906|TWO_SIDED|95.0|-1.59|21.7|||Cochran-Mantel-Haenszel|||Week 32: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||21.70|-1.59|0.0906
72332375|NCT02791516|144189202|SUPERIORITY||LS Mean Difference|9.6|STANDARD_ERROR_OF_MEAN|1.0|<|0.001|TWO_SIDED|95.0|7.6|11.5|||ANCOVA|ANCOVA model adjusting for treatment, baseline DXA BMD value, machine type, and machine type-by-baseline DXA BMD value.||||11.5|7.6|<0.001
72422864|NCT03502616|144356433|SUPERIORITY||Difference in percentage|13.03|STANDARD_ERROR_OF_MEAN|5.94||0.0282|TWO_SIDED|95.0|1.39|24.66|||Cochran-Mantel-Haenszel|||Week 40: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||24.66|1.39|0.0282
72422865|NCT03502616|144356433|SUPERIORITY||Difference in percentage|10.77|STANDARD_ERROR_OF_MEAN|5.98||0.0719|TWO_SIDED|95.0|-0.96|22.49|||Cochran-Mantel-Haenszel|||Week 48: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||22.49|-0.96|0.0719
72422866|NCT03502616|144356434|SUPERIORITY||Difference in percentage|32.79|STANDARD_ERROR_OF_MEAN|4.75|<|0.0001|TWO_SIDED|95.0|23.48|42.11|||Cochran-Mantel-Haenszel|||Week 2: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||42.11|23.48|<0.0001
72422867|NCT03502616|144356434|SUPERIORITY||Difference in percentage|40.53|STANDARD_ERROR_OF_MEAN|5.19|<|0.0001|TWO_SIDED|95.0|30.37|50.7|||Cochran-Mantel-Haenszel|||Week 4: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||50.70|30.37|<0.0001
72422868|NCT03502616|144356434|SUPERIORITY||Difference in percentage|45.22|STANDARD_ERROR_OF_MEAN|5.2|<|0.0001|TWO_SIDED|95.0|35.03|55.41|||Cochran-Mantel-Haenszel|||Week 8: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||55.41|35.03|<0.0001
72332376|NCT02791516|144189203|SUPERIORITY||LS Mean Difference|2.6|STANDARD_ERROR_OF_MEAN|0.6|<|0.001|TWO_SIDED|95.0|1.4|3.7|||ANCOVA|ANCOVA model adjusting for treatment, baseline DXA BMD value, machine type, and machine type-by-baseline DXA BMD value.||||3.7|1.4|<0.001
72422869|NCT03502616|144356434|SUPERIORITY||Difference in percentage|45.23|STANDARD_ERROR_OF_MEAN|5.23|<|0.0001|TWO_SIDED|95.0|34.97|55.49|||Cochran-Mantel-Haenszel|||Week 12: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||55.49|34.97|<0.0001
72422870|NCT03502616|144356434|SUPERIORITY||Difference in percentage|42.3|STANDARD_ERROR_OF_MEAN|5.4|<|0.0001|TWO_SIDED|95.0|31.73|52.88|||Cochran-Mantel-Haenszel|||Week 16: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||52.88|31.73|<0.0001
72422871|NCT03502616|144356434|SUPERIORITY||Difference in percentage|4.96|STANDARD_ERROR_OF_MEAN|5.85||0.3967|TWO_SIDED|95.0|-6.51|16.42|||Cochran-Mantel-Haenszel|||Week 24: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||16.42|-6.51|0.3967
72332377|NCT02791516|144189204|SUPERIORITY||LS Mean Difference|2.2|STANDARD_ERROR_OF_MEAN|0.7||0.004|TWO_SIDED|95.0|0.7|3.6|||ANCOVA|ANCOVA model adjusting for treatment, baseline DXA BMD value, machine type, and machine type-by-baseline DXA BMD value.||||3.6|0.7|0.004
72332378|NCT02644096|144189213|SUPERIORITY_OR_OTHER||||||<|0.05||||||Changes in physical function after 3 months|unpaired t-test|||"Power calculation in this study was based on findings in a previous cross-sectional study.~The physical dimensions in health status was the primary outcome variable. The mean physical score was 49.4, SD was 26.1; alpha in this study was set to 5% and β to 20%. We considered that the intervention could lead to an improvement of 50% in the physical health score and were willing to overlook a difference in score of 12. When the sample size was calculated, 68 patients were needed in both groups."||||<0.05
72332379|NCT04091581|144189214|OTHER|||||||0.002|||||||ANOVA|||||||0.002
72332380|NCT04091581|144189214|OTHER|||||||0.022|||||||t-test, 2 sided|||Comparison of the baseline tear evaporation rate of the non-dry eye and dry eye group.||||0.022
72332381|NCT03224403|144189221|SUPERIORITY||||||<|0.001||||||The significance threshold level was 0.049 (two-sided). P-values are based on the Wilcoxon test from PROC LIFETEST that compared survival curves.|Wilcoxon test from SAS PROC LIFETEST|||||||<0.001
72332382|NCT03224403|144189221|SUPERIORITY||||||<|0.001||||||The significance threshold level was 0.049 (two-sided). P-values are based on the Wilcoxon test from PROC LIFETEST that compared survival curves.|Wilcoxon test from SAS PROC LIFETEST|||||||<0.001
72332383|NCT03224403|144189221|SUPERIORITY||||||<|0.001||||||The significance threshold level was 0.049 (two-sided). P-values are based on the Wilcoxon test from PROC LIFETEST that compared survival curves.|Wilcoxon test from SAS PROC LIFETEST|||||||<0.001
72332384|NCT03224403|144189221|SUPERIORITY|||||||0.035||||||The significance threshold level was 0.049 (two-sided). P-values are from the comparison of median survival time using the bootstrap re-sampling method.|bootstrap re-sampling method|||||||0.035
72422872|NCT03502616|144356434|SUPERIORITY||Difference in percentage|4.34|STANDARD_ERROR_OF_MEAN|5.67||0.4442|TWO_SIDED|95.0|-6.78|15.46|||Cochran-Mantel-Haenszel|||Week 32: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||15.46|-6.78|0.4442
72332385|NCT03224403|144189221|SUPERIORITY||||||<|0.001||||||The significance threshold level was 0.049 (two-sided). P-values are from the comparison of median survival time using the bootstrap re-sampling method.|bootstrap re-sampling method|||||||<0.001
72332386|NCT03224403|144189222|SUPERIORITY||||||<|0.001||||||The significance threshold level was 0.049 (two-sided). P-values are based on the Wilcoxon test from PROC LIFETEST that compared survival curves.|Wilcoxon test from SAS PROC LIFETEST|||||||<0.001
72332387|NCT03224403|144189222|SUPERIORITY||||||<|0.001||||||The significance threshold level was 0.049 (two-sided). P-values are based on the Wilcoxon test from PROC LIFETEST that compared survival curves.|Wilcoxon test from SAS PROC LIFETEST|||||||<0.001
72332388|NCT03224403|144189222|SUPERIORITY||||||<|0.001||||||The significance threshold level was 0.049 (two-sided). P-values are based on the Wilcoxon test from PROC LIFETEST that compared survival curves.|Wilcoxon test from SAS PROC LIFETEST|||||||<0.001
72332389|NCT03224403|144189222|SUPERIORITY|||||||0.671||||||The significance threshold level was 0.049 (two-sided). P-values are from the comparison of median survival time using the bootstrap re-sampling method.|bootstrap re-sampling method|||||||0.671
72332390|NCT03224403|144189222|SUPERIORITY|||||||0.487||||||The significance threshold level was 0.049 (two-sided). P-values are from the comparison of median survival time using the bootstrap re-sampling method.|bootstrap re-sampling method|||||||0.487
72332391|NCT03224403|144189223|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|||||||<0.001
72332392|NCT03224403|144189224|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|||||||<0.001
72332393|NCT03224403|144189225|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|||||||<0.001
72332394|NCT03224403|144189226|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|||||||<0.001
72332395|NCT03224403|144189227|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|||||||<0.001
72332396|NCT03224403|144189228|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|||||||<0.001
72332397|NCT03224403|144189229|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|||||||<0.001
72332398|NCT03224403|144189230|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|||||||<0.001
72422873|NCT03502616|144356434|SUPERIORITY||Difference in percentage|6.38|STANDARD_ERROR_OF_MEAN|5.92||0.281|TWO_SIDED|95.0|-5.22|17.97|||Cochran-Mantel-Haenszel|||Week 40: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||17.97|-5.22|0.2810
72332399|NCT03224403|144189231|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|||||||<0.001
72332400|NCT03224403|144189232|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|||||||<0.001
72332401|NCT03224403|144189233|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|||||||<0.001
72332402|NCT03224403|144189234|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|||||||<0.001
72332403|NCT03224403|144189235|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|||||||<0.001
72332404|NCT03224403|144189236|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|||||||<0.001
72332405|NCT03224403|144189237|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|||||||<0.001
72332406|NCT03224403|144189238|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|||||||<0.001
72332407|NCT03224403|144189239|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|||||||<0.001
72332408|NCT03224403|144189240|SUPERIORITY|||||||0.007|||||||Regression, Logistic|||||||0.007
72332409|NCT03224403|144189241|SUPERIORITY|||||||0.026|||||||Regression, Logistic|||||||0.026
72332410|NCT03224403|144189242|SUPERIORITY|||||||0.08|||||||Regression, Logistic|||||||0.080
72422874|NCT03502616|144356434|SUPERIORITY||Difference in percentage|5.54|STANDARD_ERROR_OF_MEAN|5.95||0.3514|TWO_SIDED|95.0|-6.12|17.2|||Cochran-Mantel-Haenszel|||Week 48: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||17.20|-6.12|0.3514
72422875|NCT03502616|144356435|SUPERIORITY||Difference in percentage|8.84|STANDARD_ERROR_OF_MEAN|2.74||0.0013|TWO_SIDED|95.0|3.46|14.21|||Cochran-Mantel-Haenszel|||Week 2: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||14.21|3.46|0.0013
72332411|NCT01456195|144189243|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.48|STANDARD_ERROR_OF_MEAN|0.122|<|0.001|TWO_SIDED|95.0|-0.72|-0.24||MMRM model with treatment, country, visit and visit by treatment interaction as fixed factors and with baseline value and baseline value by visit interaction as covariates with an unstructured covariance structure.|Mixed model for repeated measurements|||||-0.24|-0.72|<0.001
72332412|NCT01456195|144189243|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.76|STANDARD_ERROR_OF_MEAN|0.122|<|0.001|TWO_SIDED|95.0|-1.0|-0.52||MMRM model with treatment, country, visit and visit by treatment interaction as fixed factors and with baseline value and baseline value by visit interaction as covariates with an unstructured covariance structure.|Mixed model for repeated measurements|||||-0.52|-1.00|<0.001
72332413|NCT01456195|144189244|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.13||||0.01|TWO_SIDED|95.0|1.2|3.79||P-Value used a logistic model with treatment, country and baseline HbA1c as explanatory variables.|Regression, Logistic|||||3.79|1.20|0.010
72332414|NCT01456195|144189244|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.4|||<|0.001|TWO_SIDED|95.0|2.48|7.82||P-Value used a logistic model with treatment, country and baseline HbA1c as explanatory variables.|Regression, Logistic|||||7.82|2.48|<0.001
72422876|NCT03502616|144356435|SUPERIORITY||Difference in percentage|16.25|STANDARD_ERROR_OF_MEAN|3.63|<|0.0001|TWO_SIDED|95.0|9.13|23.36|||Cochran-Mantel-Haenszel|||Week 4: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||23.36|9.13|<0.0001
72422877|NCT03502616|144356435|SUPERIORITY||Difference in percentage|20.31|STANDARD_ERROR_OF_MEAN|4.03|<|0.0001|TWO_SIDED|95.0|12.41|28.2|||Cochran-Mantel-Haenszel|||Week 8: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||28.20|12.41|<0.0001
72422878|NCT03502616|144356435|SUPERIORITY||Difference in percentage|22.77|STANDARD_ERROR_OF_MEAN|4.24|<|0.0001|TWO_SIDED|95.0|14.46|31.08|||Cochran-Mantel-Haenszel|||Week 12: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||31.08|14.46|<0.0001
72422879|NCT03502616|144356435|SUPERIORITY||Difference in percentage|25.28|STANDARD_ERROR_OF_MEAN|4.5|<|0.0001|TWO_SIDED|95.0|16.47|34.1|||Cochran-Mantel-Haenszel|||Week 16: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||34.10|16.47|<0.0001
72422880|NCT03502616|144356435|SUPERIORITY||Difference in percentage|9.41|STANDARD_ERROR_OF_MEAN|5.62||0.0941|TWO_SIDED|95.0|-1.61|20.43|||Cochran-Mantel-Haenszel|||Week 24: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||20.43|-1.61|0.0941
72422881|NCT03502616|144356435|SUPERIORITY||Difference in percentage|2.52|STANDARD_ERROR_OF_MEAN|5.96||0.6727|TWO_SIDED|95.0|-9.17|14.21|||Cochran-Mantel-Haenszel|||Week 32: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||14.21|-9.17|0.6727
72422882|NCT03502616|144356435|SUPERIORITY||Difference in percentage|7.29|STANDARD_ERROR_OF_MEAN|5.96||0.2213|TWO_SIDED|95.0|-4.39|18.98|||Cochran-Mantel-Haenszel|||Week 40: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||18.98|-4.39|0.2213
72422883|NCT03502616|144356435|SUPERIORITY||Difference in percentage|4.7|STANDARD_ERROR_OF_MEAN|5.76||0.4137|TWO_SIDED|95.0|-6.58|15.98|||Cochran-Mantel-Haenszel|||Week 48: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||15.98|-6.58|0.4137
72422884|NCT03502616|144356436|SUPERIORITY||Difference in percentage|0.75|STANDARD_ERROR_OF_MEAN|1.27||0.5518|TWO_SIDED|95.0|-1.73|3.24|||Cochran-Mantel-Haenszel|||Week 2: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||3.24|-1.73|0.5518
72422885|NCT03502616|144356436|SUPERIORITY||Difference in percentage|3.72|STANDARD_ERROR_OF_MEAN|1.92||0.0524|TWO_SIDED|95.0|-0.04|7.47|||Cochran-Mantel-Haenszel|||Week 4: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||7.47|-0.04|0.0524
72422886|NCT03502616|144356436|SUPERIORITY||Difference in percentage|5.25|STANDARD_ERROR_OF_MEAN|2.29||0.0216|TWO_SIDED|95.0|0.77|9.73|||Cochran-Mantel-Haenszel|||Week 8: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||9.73|0.77|0.0216
72422887|NCT03502616|144356436|SUPERIORITY||Difference in percentage|10.48|STANDARD_ERROR_OF_MEAN|2.9||0.0003|TWO_SIDED|95.0|4.8|16.17|||Cochran-Mantel-Haenszel|||Week 12: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||16.17|4.80|0.0003
72422888|NCT03502616|144356436|SUPERIORITY||Difference in percentage|6.69|STANDARD_ERROR_OF_MEAN|2.37||0.0047|TWO_SIDED|95.0|2.05|11.33|||Cochran-Mantel-Haenszel|||Week 16: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||11.33|2.05|0.0047
72332415|NCT01456195|144189245|SUPERIORITY_OR_OTHER||LS Mean Difference|-13.7|STANDARD_ERROR_OF_MEAN|4.59||0.003|TWO_SIDED|95.0|-22.7|-4.6||Mixed Model Repeated Measures (MMRM) model with treatment, country, visit and visit by treatment interaction as fixed factors and with baseline value and baseline value by visit interaction as covariates with an unstructured covariance structure.|Mixed model for repeated measurements|||||-4.6|-22.7|0.003
72422889|NCT03502616|144356436|SUPERIORITY||Difference in percentage|1.07|STANDARD_ERROR_OF_MEAN|3.98||0.7883|TWO_SIDED|95.0|-6.74|8.88|||Cochran-Mantel-Haenszel|||Week 24: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||8.88|-6.74|0.7883
72332416|NCT01456195|144189245|SUPERIORITY_OR_OTHER||LS Mean Difference|-22.3|STANDARD_ERROR_OF_MEAN|4.6|<|0.001|TWO_SIDED|95.0|-31.4|-13.2||MMRM model with treatment, country, visit and visit by treatment interaction as fixed factors and with baseline value and baseline value by visit interaction as covariates with an unstructured covariance structure.|Mixed model for repeated measurements|||||-13.2|-31.4|<0.001
72332417|NCT01456195|144189246|SUPERIORITY_OR_OTHER||LS Mean Difference|-28.8|STANDARD_ERROR_OF_MEAN|17.17||0.1|TWO_SIDED|95.0|-63.2|5.7||ANCOVA model with treatment and country as fixed factors and baseline value as covariate.|ANCOVA|||||5.7|-63.2|0.100
72332418|NCT01456195|144189246|SUPERIORITY_OR_OTHER||LS Mean Difference|-30.0|STANDARD_ERROR_OF_MEAN|17.7||0.096|TWO_SIDED|95.0|-65.5|5.5||ANCOVA model with treatment and country as fixed factors and baseline value as covariate.|ANCOVA|||||5.5|-65.5|0.096
72332419|NCT01340625|144189248|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|107.84|||||TWO_SIDED|90.0|100.91|115.24|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||115.24|100.91|
72332420|NCT01340625|144189249|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|104.03|||||TWO_SIDED|90.0|96.74|111.88|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||111.88|96.74|
72332421|NCT01340625|144189250|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|101.97|||||TWO_SIDED|90.0|95.73|108.62|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||108.62|95.73|
72368993|NCT01039376|144247964|SUPERIORITY||Mean Difference (Final Values)|-4.32||||0.0055|TWO_SIDED|95.0|-7.37|-1.28||The analysis is adjusted for BL score, actual strata, age group, BL ECOG performance status and Binet stage at Screening using mixed-model (Proc Mixed) repeated with intercept, BL score by time and treatment by time interaction.|Repeated measures analysis of covariance||Social Problems Scale|||-1.28|-7.37|0.0055
72368994|NCT01039376|144247964|SUPERIORITY||Mean Difference (Final Values)|-2.49||||0.0063|TWO_SIDED|95.0|-4.27|-0.71||The analysis is adjusted for BL score, actual strata, age group, BL ECOG performance status and Binet stage at Screening using mixed-model (Proc Mixed) repeated with intercept, BL score by time and treatment by time interaction.|Repeated measures analysis of covariance||Side Effects Scale|||-0.71|-4.27|0.0063
72332422|NCT01340625|144189251|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|96.24|||||TWO_SIDED|90.0|90.04|102.86|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||102.86|90.04|
72332423|NCT01340625|144189252|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|98.8|||||TWO_SIDED|90.0|93.89|103.97|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||103.97|93.89|
72332424|NCT01340625|144189253|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|99.59|||||TWO_SIDED|90.0|94.91|104.5|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||104.50|94.91|
72332425|NCT01668628|144189255|SUPERIORITY_OR_OTHER|||||||0.008|TWO_SIDED||||||t-test, 2 sided|||Student's t-test: Comparison of baseline physical health score between Normohydration group and Overhydration group.||||0.008
72332426|NCT01668628|144189255|SUPERIORITY_OR_OTHER|||||||0.008|TWO_SIDED||||||t-test, 2 sided|||Student's t test: Comparison of baseline mental health score between Normohydration group and Overhydration group.||||0.008
72332427|NCT01668628|144189255|SUPERIORITY_OR_OTHER|||||||0.008|TWO_SIDED||||||t-test, 2 sided|||Student's t test: Comparison of baseline kidney disease component score between Normohydration group and Overhydration group||||0.008
72332428|NCT01668628|144189255|SUPERIORITY_OR_OTHER|||||||0.157|TWO_SIDED||||||t-test, 2 sided|||Student's t test: Comparison of baseline BDI score between Normohydration group and Overhydration group.||||0.157
72332429|NCT00734604|144189266|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.12|STANDARD_ERROR_OF_MEAN|0.04||0.001|TWO_SIDED|95.0|0.04|0.19||p-value is for difference in LS Means change from baseline between tadalafil OaD and Sildenafil PRN.|t-test|Kenward-Roger approximation was used for denominator degrees of freedom in the mixed model.||||0.19|0.04|0.001
72332430|NCT00734604|144189267|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.04||0.872|TWO_SIDED|95.0|-0.06|0.08||p-value is for difference in Pairs Sexual Self-Confidence Domain Score LS Mean and Change from Baseline between Tadalafil OaD and Tadalafil PRN Population|t-test|Kenward-Roger approximation was used for denominator degrees of freedom in the mixed model.|LS Mean difference = Tadalafil OaD-Tadalafil PRN|||0.08|-0.06|0.872
72332431|NCT00734604|144189268|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.15|STANDARD_ERROR_OF_MEAN|0.03|<|0.001|TWO_SIDED|95.0|0.1|0.2||p-value is for difference between Tadalafil OaD and Sildenafil PRN change from baseline in LS Mean.|t-test|Kenward-Roger approximation was used for denominator degrees of freedom in the mixed model.||||0.20|0.10|<0.001
72332432|NCT00734604|144189268|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.03||0.395|TWO_SIDED|95.0|-0.03|0.07||p-value is for difference between Tadalafil OaD and Tadalafil PRN in change from baseline in LS Mean.|t-test|Kenward-Roger approximation was used for denominator degrees of freedom in the mixed model.||||0.07|-0.03|0.395
72332433|NCT00734604|144189269|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.31|STANDARD_ERROR_OF_MEAN|0.03|<|0.001|TWO_SIDED|95.0|-0.36|-0.25||p-value is for the difference between Tadalafil OaD and Sildenafil PRN in Change from Baseline in LS Mean.|t-test|Kenward-Roger approximation was used for denominator degrees of freedom in the mixed model.||||-0.25|-0.36|<0.001
72422890|NCT03502616|144356436|SUPERIORITY||Difference in percentage|4.85|STANDARD_ERROR_OF_MEAN|4.4||0.2708|TWO_SIDED|95.0|-3.78|13.48|||Cochran-Mantel-Haenszel|||Week 32: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||13.48|-3.78|0.2708
72332434|NCT00734604|144189269|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.14|STANDARD_ERROR_OF_MEAN|0.03|<|0.001|TWO_SIDED|95.0|-0.2|-0.08||p-value is for the difference between Tadalafil OaD and Tadalafil PRN in Change from Baseline in LS Mean.|t-test|Kenward-Roger approximation was used for denominator degrees of freedom in the mixed model.||||-0.08|-0.20|<0.001
72332435|NCT00734604|144189270|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.85|STANDARD_ERROR_OF_MEAN|0.3||0.004|TWO_SIDED|95.0|-1.43|-0.27||p-value is for the difference between Tadalafil OaD and Sildenafil PRN Change from Baseline in LS Means.|t-test|Kenward-Roger approximation was used for denominator degrees of freedom in the mixed model.||||-0.27|-1.43|0.004
72332436|NCT00734604|144189270|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8|STANDARD_ERROR_OF_MEAN|0.29||0.007|TWO_SIDED|95.0|-1.37|-0.22||p-value is for the difference between Tadalafil OaD and Tadalafil PRN Change from Baseline in LS Means.|t-test|Kenward-Roger approximation was used for denominator degrees of freedom in the mixed model.||||-0.22|-1.37|0.007
72332437|NCT00734604|144189271|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.06|STANDARD_ERROR_OF_MEAN|0.01|<|0.001|TWO_SIDED|95.0|0.03|0.09||p-value is for difference between Tadalafil OaD and Tadalafil PRN Change from Baseline in LS Means.|t-test|Kenward-Roger approximation was used for denominator degrees of freedom in the mixed model.||||0.09|0.03|<0.001
72332438|NCT00734604|144189271|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.09|STANDARD_ERROR_OF_MEAN|0.01|<|0.001|TWO_SIDED|95.0|0.06|0.12||p-value is for difference between Tadalafil OaD and Sildenafil PRN Change from Baseline in LS Means.|t-test|Kenward-Roger approximation was used for denominator degrees of freedom in the mixed model.||||0.12|0.06|<0.001
72332439|NCT00734604|144189272|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.64|STANDARD_ERROR_OF_MEAN|0.14|<|0.001|TWO_SIDED|95.0|-0.91|-0.36||p-value is for difference between Tadalafil OaD and Sildenafil PRN Change from Baseline in LS Means.|t-test|Kenward-Roger approximation was used for denominator degrees of freedom in the mixed model.||||-0.36|-0.91|<0.001
72332440|NCT00734604|144189272|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.51|STANDARD_ERROR_OF_MEAN|0.14|<|0.001|TWO_SIDED|95.0|-0.78|-0.23||p-value is for difference between Tadalafil OaD and Tadalafil PRN Change from Baseline in LS Means.|t-test|||||-0.23|-0.78|<0.001
72332441|NCT00734604|144189273|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.22|STANDARD_ERROR_OF_MEAN|0.11||0.055|TWO_SIDED|95.0|-0.44|0.0||p-value is for the difference between Tadalafil OaD and Sildenafil PRN Change from Baseline in LS Means.|t-test|Kenward-Roger approximation was used for denominator degrees of freedom in the mixed model.||||0.00|-0.44|0.055
72332442|NCT00734604|144189273|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.22|STANDARD_ERROR_OF_MEAN|0.11||0.046|TWO_SIDED|95.0|-0.44|0.0||p-value is for the difference between Tadalafil OaD and Tadalafil PRN Change from Baseline in LS Means.|t-test|Kenward-Roger approximation was used for denominator degrees of freedom in the mixed model.||||0.00|-0.44|0.046
72332443|NCT00734604|144189274|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.66|STANDARD_ERROR_OF_MEAN|1.27||0.004|TWO_SIDED|95.0|1.16|6.17||p-value is for the difference between Tadalafil PRN and Sildenafil PRN change in LS Means.|t-test|Kenward-Roger approximation was used for denominator degrees of freedom in the mixed model.||||6.17|1.16|0.004
72332444|NCT00734604|144189274|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.55|STANDARD_ERROR_OF_MEAN|1.27||0.006|TWO_SIDED|95.0|-6.05|-1.04||p-value is for the difference between Tadalafil OaD and Tadalafil PRN change in LS Means.|t-test|Kenward-Roger approximation was used for denominator degrees of freedom in the mixed model.||||-1.04|-6.05|0.006
72332445|NCT00734604|144189276|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.11|STANDARD_ERROR_OF_MEAN|1.05||0.915|TWO_SIDED|95.0|-1.95|2.17||p-value is for the difference between Tadalafil OaD and Sildenafil PRN Change from Baseline in LS Means.|t-test|Kenward-Roger approximation was used for denominator degrees of freedom in the mixed model.||||2.17|-1.95|0.915
72332446|NCT00734604|144189276|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.3|STANDARD_ERROR_OF_MEAN|1.04||0.212|TWO_SIDED|95.0|-3.35|0.74||p-value is for the difference between Tadalafil OaD and Tadalafil PRN Change from Baseline in LS Means.|t-test|Kenward-Roger approximation was used for denominator degrees of freedom in the mixed model.||||0.74|-3.35|0.212
72332447|NCT00734604|144189277|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.07|STANDARD_ERROR_OF_MEAN|0.08||0.403|TWO_SIDED|95.0|-0.09|0.22||p-value is for the difference between Tadalafil OaD and Sildenafil PRN in LS Means.|Generalized Linear Mixed Model|||||0.22|-0.09|0.403
72332448|NCT00734604|144189277|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.07|STANDARD_ERROR_OF_MEAN|0.08||0.367|TWO_SIDED|95.0|-0.08|0.23||p-value is for the difference between Tadalafil OaD and Tadalafil PRN in LS Means.|Generalized Linear Mixed Model|||||0.23|-0.08|0.367
72332449|NCT00734604|144189278|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|0.06||0.002|TWO_SIDED|95.0|0.07|0.32||p-value is for the difference between Tadalafil OaD and Sildenafil PRN in LS Means.|Generalized Linear Mixed Model|||||0.32|0.07|0.002
72332450|NCT00734604|144189278|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.06||0.722|TWO_SIDED|95.0|-0.15|0.1||p-value is for the difference between Tadalafil OaD and Tadalafil PRN in LS Means.|Generalized Linear Mixed Model|||||0.10|-0.15|0.722
72332451|NCT00734604|144189279|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.51|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|95.0|-0.65|-0.37||p-value is for the difference between Tadalafil OaD and Sildenafil PRN in LS Means.|Generalized Linear Mixed Model|||||-0.37|-0.65|<0.001
72332452|NCT00734604|144189279|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.29|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|95.0|-0.43|-0.16||p-value is for the difference between Tadalafil OaD and Tadalafil PRN in LS Means.|Generalized Linear Mixed Model|||||-0.16|-0.43|<0.001
72422891|NCT03502616|144356436|SUPERIORITY||Difference in percentage|0.44|STANDARD_ERROR_OF_MEAN|4.55||0.9226|TWO_SIDED|95.0|-8.48|9.36|||Cochran-Mantel-Haenszel|||Week 40: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||9.36|-8.48|0.9226
72332453|NCT00734604|144189280|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.11|STANDARD_ERROR_OF_MEAN|0.06||0.07|TWO_SIDED|95.0|-0.01|0.22||p-value is for the difference between Tadalafil OaD and Sildenafil PRN in LS Means.|Generalized Linear Mixed Model|||||0.22|-0.01|0.070
72332454|NCT00734604|144189280|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.03|STANDARD_ERROR_OF_MEAN|0.06||0.637|TWO_SIDED|95.0|-0.14|0.09||p-value is for the difference between Tadalafil OaD and Tadalafil PRN in LS Means.|Generalized Linear Mixed Model|||||0.09|-0.14|0.637
72332455|NCT02589665|144189281|SUPERIORITY||Odds Ratio (OR)|2.93|||||TWO_SIDED|95.0|0.7|12.27||||||||12.27|0.70|
72332456|NCT02589665|144189281|SUPERIORITY||Odds Ratio (OR)|7.22|||||TWO_SIDED|95.0|1.88|27.65||||||||27.65|1.88|
72332457|NCT02589665|144189281|SUPERIORITY||Odds Ratio (OR)|3.61|||||TWO_SIDED|95.0|0.92|14.17||||||||14.17|0.92|
72422892|NCT03502616|144356436|SUPERIORITY||Difference in percentage|1.84|STANDARD_ERROR_OF_MEAN|4.23||0.663|TWO_SIDED|95.0|-6.44|10.13|||Cochran-Mantel-Haenszel|||Week 48: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||10.13|-6.44|0.6630
72422893|NCT03502616|144356437|SUPERIORITY||LS mean difference|-0.84|STANDARD_ERROR_OF_MEAN|0.319||0.0099|TWO_SIDED|95.0|-1.47|-0.2|||Mixed Models Analysis|||Week 4: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-0.20|-1.47|0.0099
72332458|NCT02589665|144189282|SUPERIORITY||Odds Ratio (OR)|3.95|||||TWO_SIDED|95.0|1.73|8.98||||||||8.98|1.73|
72332459|NCT02589665|144189282|SUPERIORITY||Odds Ratio (OR)|6.78|||||TWO_SIDED|95.0|2.94|15.63||||||||15.63|2.94|
72332460|NCT02589665|144189282|SUPERIORITY||Odds Ratio (OR)|2.78|||||TWO_SIDED|95.0|1.23|6.29||||||||6.29|1.23|
72332461|NCT02589665|144189283|SUPERIORITY|||||||0.986|||||||Mantel Haenszel|||||||0.986
72332462|NCT02589665|144189283|SUPERIORITY|||||||0.553|||||||Mantel Haenszel|||||||0.553
72332463|NCT02589665|144189283|SUPERIORITY|||||||0.56|||||||Mantel Haenszel|||||||0.560
72332464|NCT02589665|144189284|SUPERIORITY||Odds Ratio (OR)|2.29|||||TWO_SIDED|95.0|0.8|6.55||||||||6.55|0.80|
72332465|NCT02589665|144189285|SUPERIORITY||Mean Difference (Final Values)|22.9|||||TWO_SIDED|95.0|11.0|34.9||||||||34.9|11.0|
72332466|NCT02589665|144189285|SUPERIORITY||Mean Difference (Final Values)|20.5|||||TWO_SIDED|95.0|8.7|32.3||||||||32.3|8.7|
72332467|NCT02589665|144189285|SUPERIORITY||Mean Difference (Final Values)|10.7|||||TWO_SIDED|95.0|-1.0|22.5||||||||22.5|-1.0|
72332468|NCT02589665|144189287|SUPERIORITY||Mean Difference (Final Values)|-0.9|||||TWO_SIDED|95.0|-1.39|-0.41||||||||-0.41|-1.39|
72332469|NCT02589665|144189287|SUPERIORITY||Mean Difference (Final Values)|-1.06|||||TWO_SIDED|95.0|-1.54|-0.59||||||||-0.59|-1.54|
72332470|NCT02589665|144189287|SUPERIORITY||Mean Difference (Final Values)|-0.59|||||TWO_SIDED|95.0|-1.07|-0.11||||||||-0.11|-1.07|
72332471|NCT02589665|144189290|SUPERIORITY||Odds Ratio (OR)|3.61||||0.003|TWO_SIDED|95.0|1.57|8.31|||Regression, Logistic|||||8.31|1.57|0.003
72332472|NCT02589665|144189290|SUPERIORITY||Odds Ratio (OR)|6.54|||<|0.001|TWO_SIDED|95.0|2.81|15.2|||Regression, Logistic|||||15.20|2.81|<0.001
72332473|NCT02589665|144189290|SUPERIORITY||Odds Ratio (OR)|2.27||||0.054|TWO_SIDED|95.0|0.98|5.22|||Regression, Logistic|||||5.22|0.98|0.054
72332474|NCT02589665|144189291|SUPERIORITY||Odds Ratio (OR)|0.48||||0.131|TWO_SIDED|95.0|0.19|1.24|||Regression, Logistic|||||1.24|0.19|0.131
72332475|NCT02589665|144189292|SUPERIORITY||Odds Ratio (OR)|2.25||||0.215|TWO_SIDED|95.0|0.63|8.07|||Regression, Logistic|||||8.07|0.63|0.215
72332476|NCT02589665|144189292|SUPERIORITY||Odds Ratio (OR)|7.7|||<|0.001|TWO_SIDED|95.0|2.37|25.0|||Regression, Logistic|||||25.00|2.37|<0.001
72332477|NCT02589665|144189292|SUPERIORITY||Odds Ratio (OR)|4.62||||0.012|TWO_SIDED|95.0|1.41|15.14|||Regression, Logistic|||||15.14|1.41|0.012
72332478|NCT02589665|144189293|SUPERIORITY||Odds Ratio (OR)|0.71||||0.428|TWO_SIDED|95.0|0.31|1.65|||Regression, Logistic|||||1.65|0.31|0.428
72422894|NCT03502616|144356437|SUPERIORITY||LS mean difference|-0.74|STANDARD_ERROR_OF_MEAN|0.332||0.0275|TWO_SIDED|95.0|-1.4|-0.08|||Mixed Models Analysis|||Week 8: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-0.08|-1.40|0.0275
72332479|NCT01519791|144189308|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.283|||<|0.001|TWO_SIDED|95.0|1.503|3.468|||Regression, Logistic||The Odds ratio measuring the treatment effect was estimated from a logistic regression model including terms for treatment, region and stratification factor. Nonresponder imputation (NRI) was used.|"In order to control the overall study-wise Type I error rate at 5 %, hypothesis testing was performed in the following hierarchical order (each at a 2-sided 95 % alpha level):~1. Primary: sustained DAS28(ESR) remission at Week 52~2. Key secondary: sustained DAS28(ESR) LDA at Week 52~3. ACR50 response at Week 52 in relation to Baseline~4. Change from Baseline in HAQ-DI at Week 52~5. Change from Baseline in mTSS at Week 52"||3.468|1.503|<0.001
72368995|NCT01039376|144247965|SUPERIORITY||Mean Difference (Final Values)|-1.48||||0.1816|TWO_SIDED|95.0|-3.64|0.69||The analysis is adjusted for BL score, actual strata, age group, BL ECOG performance status and Binet stage at Screening using mixed-model (Proc Mixed) repeated with intercept, BL score by time and treatment by time interaction.|Repeated measures analysis of covariance||Appetite Loss|||0.69|-3.64|0.1816
72422895|NCT03502616|144356437|SUPERIORITY||LS mean difference|-0.72|STANDARD_ERROR_OF_MEAN|0.35||0.042|TWO_SIDED|95.0|-1.41|-0.03|||Mixed Models Analysis|||Week 12: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-0.03|-1.41|0.0420
72422896|NCT03502616|144356437|SUPERIORITY||LS mean difference|-0.53|STANDARD_ERROR_OF_MEAN|0.349||0.1309|TWO_SIDED|95.0|-1.22|0.16|||Mixed Models Analysis|||Week 16: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.16|-1.22|0.1309
72422897|NCT03502616|144356437|SUPERIORITY||LS mean difference|-0.18|STANDARD_ERROR_OF_MEAN|0.305||0.5566|TWO_SIDED|95.0|-0.78|0.42|||Mixed Models Analysis|||Week 24: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.42|-0.78|0.5566
72422898|NCT03502616|144356437|SUPERIORITY||LS mean difference|-0.19|STANDARD_ERROR_OF_MEAN|0.248||0.4497|TWO_SIDED|95.0|-0.68|0.3|||Mixed Models Analysis|||Week 32: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.30|-0.68|0.4497
72422899|NCT03502616|144356437|SUPERIORITY||LS mean difference|0.02|STANDARD_ERROR_OF_MEAN|0.227||0.9272|TWO_SIDED|95.0|-0.43|0.47|||Mixed Models Analysis|||Week 40: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.47|-0.43|0.9272
72422900|NCT03502616|144356437|SUPERIORITY||LS mean difference|-0.31|STANDARD_ERROR_OF_MEAN|0.273||0.2539|TWO_SIDED|95.0|-0.85|0.23|||Mixed Models Analysis|||Week 48: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.23|-0.85|0.2539
72422901|NCT03502616|144356438|SUPERIORITY||LS mean difference|0.37|STANDARD_ERROR_OF_MEAN|0.479||0.4379|TWO_SIDED|95.0|-0.58|1.33|||Mixed Models Analysis|||Week 2: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||1.33|-0.58|0.4379
72368996|NCT01039376|144247965|SUPERIORITY||Mean Difference (Final Values)|1.4||||0.2863|TWO_SIDED|95.0|-1.18|3.97||The analysis is adjusted for BL score, actual strata, age group, BL ECOG performance status and Binet stage at Screening using mixed-model (Proc Mixed) repeated with intercept, BL score by time and treatment by time interaction.|Repeated measures analysis of covariance||Cognitive Functioning|||3.97|-1.18|0.2863
72368997|NCT01039376|144247965|SUPERIORITY||Mean Difference (Final Values)|-1.97||||0.0932|TWO_SIDED|95.0|-4.28|0.33||The analysis is adjusted for BL score, actual strata, age group, BL ECOG performance status and Binet stage at Screening using mixed-model (Proc Mixed) repeated with intercept, BL score by time and treatment by time interaction.|Repeated measures analysis of covariance||Constipation|||0.33|-4.28|0.0932
72368998|NCT01039376|144247965|SUPERIORITY||Mean Difference (Final Values)|0.5||||0.6533|TWO_SIDED|95.0|-1.67|2.66||The analysis is adjusted for BL score, actual strata, age group, BL ECOG performance status and Binet stage at Screening using mixed-model (Proc Mixed) repeated with intercept, BL score by time and treatment by time interaction.|Repeated measures analysis of covariance||Diarrhoea|||2.66|-1.67|0.6533
72368999|NCT01039376|144247965|SUPERIORITY||Mean Difference (Final Values)|-2.32||||0.0963|TWO_SIDED|95.0|-5.06|0.42||The analysis is adjusted for BL score, actual strata, age group, BL ECOG performance status and Binet stage at Screening using mixed-model (Proc Mixed) repeated with intercept, BL score by time and treatment by time interaction.|Repeated measures analysis of covariance||Dyspnoea|||0.42|-5.06|0.0963
72369000|NCT01039376|144247965|SUPERIORITY||Mean Difference (Final Values)|3.89||||0.0037|TWO_SIDED|95.0|1.27|6.51||The analysis is adjusted for BL score, actual strata, age group, BL ECOG performance status and Binet stage at Screening using mixed-model (Proc Mixed) repeated with intercept, BL score by time and treatment by time interaction.|Repeated measures analysis of covariance||Emotional Functioning|||6.51|1.27|0.0037
72369001|NCT01039376|144247965|SUPERIORITY||Mean Difference (Final Values)|-4.63||||0.0013|TWO_SIDED|95.0|-7.45|-1.82||The analysis is adjusted for BL score, actual strata, age group, BL ECOG performance status and Binet stage at Screening using mixed-model (Proc Mixed) repeated with intercept, BL score by time and treatment by time interaction.|Repeated measures analysis of covariance||Fatigue|||-1.82|-7.45|0.0013
72369002|NCT01039376|144247965|SUPERIORITY||Mean Difference (Final Values)|-1.76||||0.2902|TWO_SIDED|95.0|-5.02|1.51||The analysis is adjusted for BL score, actual strata, age group, BL ECOG performance status and Binet stage at Screening using mixed-model (Proc Mixed) repeated with intercept, BL score by time and treatment by time interaction.|Repeated measures analysis of covariance||Financial Difficulties|||1.51|-5.02|0.2902
72369003|NCT01039376|144247965|SUPERIORITY||Mean Difference (Final Values)|-1.22||||0.0606|TWO_SIDED|95.0|-2.49|0.05||The analysis is adjusted for BL score, actual strata, age group, BL ECOG performance status and Binet stage at Screening using mixed-model (Proc Mixed) repeated with intercept, BL score by time and treatment by time interaction.|Repeated measures analysis of covariance||Nausea and Vomiting|||0.05|-2.49|0.0606
72332480|NCT01519791|144189309|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.957|||<|0.001|TWO_SIDED|95.0|1.384|2.767|||Regression, Logistic||The Odds ratio measuring the treatment effect was estimated from a logistic regression model including terms for treatment, region and stratification factor. Nonresponder imputation (NRI) was used.|"In order to control the overall study-wise Type I error rate at 5 %, hypothesis testing was performed in the following hierarchical order (each at a 2-sided 95 % alpha level):~1. Primary: sustained DAS28(ESR) remission at Week 52~2. Key secondary: sustained DAS28(ESR) LDA at Week 52~3. ACR50 response at Week 52 in relation to Baseline~4. Change from Baseline in HAQ-DI at Week 52~5. Change from Baseline in mTSS at Week 52"||2.767|1.384|<0.001
72369004|NCT01039376|144247965|SUPERIORITY||Mean Difference (Final Values)|-3.04||||0.0393|TWO_SIDED|95.0|-5.93|-0.15||The analysis is adjusted for BL score, actual strata, age group, BL ECOG performance status and Binet stage at Screening using mixed-model (Proc Mixed) repeated with intercept, BL score by time and treatment by time interaction.|Repeated measures analysis of covariance||Pain|||-0.15|-5.93|0.0393
72369005|NCT01039376|144247965|SUPERIORITY||Mean Difference (Final Values)|1.81||||0.0968|TWO_SIDED|95.0|-0.33|3.96||The analysis is adjusted for BL score, actual strata, age group, BL ECOG performance status and Binet stage at Screening using mixed-model (Proc Mixed) repeated with intercept, BL score by time and treatment by time interaction.|Repeated measures analysis of covariance||Physical Functioning|||3.96|-0.33|0.0968
72369006|NCT01039376|144247965|SUPERIORITY||Mean Difference (Final Values)|1.78||||0.1449|TWO_SIDED|95.0|-0.61|4.17||The analysis is adjusted for BL score, actual strata, age group, BL ECOG performance status and Binet stage at Screening using mixed-model (Proc Mixed) repeated with intercept, BL score by time and treatment by time interaction.|Repeated measures analysis of covariance||Global Health Status/QOL|||4.17|-0.61|0.1449
72332481|NCT01519791|144189310|SUPERIORITY_OR_OTHER||Hodges-Lehmann point estimate of shift|-0.978|||<|0.001|TWO_SIDED|95.0|-1.005|-0.5|||ANCOVA on ranks||"ANCOVA model on the ranks with the terms for treatment, region, and time since RA diagnosis at Baseline (≤4 months or \>4 months) as factors and rank Baseline value as a covariate.~Confidence Interval is an asymptotic Moses CI."|"In order to control the overall study-wise Type I error rate at 5 %, hypothesis testing was performed in the following hierarchical order (each at a 2-sided 95 % alpha level):~1. Primary: sustained DAS28(ESR) remission at Week 52~2. Key secondary: sustained DAS28(ESR) LDA at Week 52~3. ACR50 response at Week 52 in relation to Baseline~4. Change from Baseline in HAQ-DI at Week 52~5. Change from Baseline in mTSS at Week 52"||-0.500|-1.005|<0.001
72332482|NCT01519791|144189315|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.446|||=|0.023|TWO_SIDED|95.0|1.052|1.989|||Regression, Logistic||The Odds ratio was estimated from a logistic regression model including terms for treatment, region and stratification factor. Nonresponder imputation (NRI) was used.|"In order to control the overall study-wise Type I error rate at 5 %, hypothesis testing was performed in the following hierarchical order (each at a 2-sided 95 % alpha level):~1. Primary: sustained DAS28(ESR) remission at Week 52~2. Key secondary: sustained DAS28(ESR) LDA at Week 52~3. ACR50 response at Week 52 in relation to Baseline~4. Change from Baseline in HAQ-DI at Week 52~5. Change from Baseline in mTSS at Week 52"||1.989|1.052|=0.023
72332483|NCT01519791|144189327|SUPERIORITY_OR_OTHER||Difference in Least Squares (LS) Means|-0.177|STANDARD_ERROR_OF_MEAN|0.049|<|0.001|TWO_SIDED|95.0|-0.273|-0.082|||ANCOVA||The CfB in HAQ-DI at Week 52 was analyzed using an ANCOVA model with terms for treatment, region, and time since Rheumatoid Arthritis (RA) diagnosis at Baseline (≤4 months or \>4 months) as factors and Baseline value as a covariate.|"In order to control the overall study-wise Type I error rate at 5 %, hypothesis testing was performed in the following hierarchical order (each at a 2-sided 95 % alpha level):~1. Primary: sustained DAS28(ESR) remission at Week 52~2. Key secondary: sustained DAS28(ESR) LDA at Week 52~3. ACR50 response at Week 52 in relation to Baseline~4. Change from Baseline in HAQ-DI at Week 52~5. Change from Baseline in mTSS at Week 52"||-0.082|-0.273|<0.001
72332484|NCT00473668|144189345|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was demonstrated if upper limit (UL) of the two-sided 95% confidence interval (CI) for the differences between the two groups in terms of anti-PRP seroprotection (SPR) rates was below (\<) 10%.|Difference in anti-PRP SPR rate|-1.18|||||TWO_SIDED|95.0|-6.39|2.84||||||Demonstration of the non-inferiority of Tritanrix™-HepB/Hiberix™ Kft. vaccine compared to Tritanrix™-HepB/Hiberix™ vaccine with respect to the anti-PRP antibody response, after a three-dose primary vaccination course.||2.84|-6.39|
72332485|NCT00473668|144189345|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was demonstrated if upper limit (UL) of the two-sided 95% confidence interval (CI) for the differences between the two groups in terms of anti-PRP seroprotection (SPR) rates was below (\<) 10%.|Difference in anti-PRP SPR rate|0.0|||||TWO_SIDED|95.0|-4.16|3.99||||||Demonstration of the non-inferiority of Tritanrix™-HepB/Hiberix™ Kft. vaccine compared to Tritanrix™-HepB/Hiberix™ vaccine with respect to the anti-PRP antibody response, after a three-dose primary vaccination course.||3.99|-4.16|
72332486|NCT02226562|144189360|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.1||||0.0001|TWO_SIDED|95.0|-1.28|-0.92||The P-value was less than 0.0001|ANCOVA|ANCOVA with a factor for treatment and baseline as covariate||||-0.92|-1.28|0.0001
72369007|NCT01039376|144247965|SUPERIORITY||Mean Difference (Final Values)|3.56||||0.0259|TWO_SIDED|95.0|0.43|6.7||The analysis is adjusted for BL score, actual strata, age group, BL ECOG performance status and Binet stage at Screening using mixed-model (Proc Mixed) repeated with intercept, BL score by time and treatment by time interaction.|Repeated measures analysis of covariance||Role Functioning|||6.70|0.43|0.0259
72369008|NCT01039376|144247965|SUPERIORITY||Mean Difference (Final Values)|3.65||||0.0175|TWO_SIDED|95.0|0.64|6.65||The analysis is adjusted for BL score, actual strata, age group, BL ECOG performance status and Binet stage at Screening using mixed-model (Proc Mixed) repeated with intercept, BL score by time and treatment by time interaction.|Repeated measures analysis of covariance||Social Functioning|||6.65|0.64|0.0175
72369009|NCT01039376|144247965|SUPERIORITY||Mean Difference (Final Values)|-1.79||||0.3209|TWO_SIDED|95.0|-5.33|1.75||The analysis is adjusted for BL score, actual strata, age group, BL ECOG performance status and Binet stage at Screening using mixed-model (Proc Mixed) repeated with intercept, BL score by time and treatment by time interaction.|Repeated measures analysis of covariance||Insomnia|||1.75|-5.33|0.3209
72369010|NCT01039376|144247966|SUPERIORITY||Mean Difference (Final Values)|0.03||||0.011|TWO_SIDED|95.0|0.01|0.06||The analysis is adjusted for BL score, actual strata, age group, BL ECOG performance status and Binet stage at Screening using mixed-model (Proc Mixed) repeated with intercept, BL score by time and treatment by time interaction.|Repeated measures analysis of covariance||Utility Score|||0.06|0.01|0.0110
72369011|NCT01039376|144247966|SUPERIORITY||Mean Difference (Final Values)|1.38||||0.1999|TWO_SIDED|95.0|-0.73|3.49||The analysis is adjusted for BL score, actual strata, age group, BL ECOG performance status and Binet stage at Screening using mixed-model (Proc Mixed) repeated with intercept, BL score by time and treatment by time interaction.|Repeated measures analysis of covariance||Thermometer Score|||3.49|-0.73|0.1999
72369012|NCT01039376|144247978|SUPERIORITY||Hazard Ratio (HR)|1.547|||||TWO_SIDED|95.0|1.051|2.276|||||HR estimated for Cytogenetics Group (based on \>=20% cut-off) with 6q-, or +12q or 13q-/no abberation|||2.276|1.051|
72369013|NCT01039376|144247978|SUPERIORITY||Hazard Ratio (HR)|9.303|||||TWO_SIDED|95.0|4.934|17.54|||||HR estimated for Cytogenetics Group (based on \>=20% cut-off) with 17p-/no abberation|||17.540|4.934|
72332487|NCT01474772|144189367|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.22|STANDARD_ERROR_OF_MEAN|0.12||0.0659|TWO_SIDED|95.0|-0.46|0.01||Primary analysis was two-sided and performed at the 0.05 significance level. The study was considered positive only if both co-primary endpoints had p-values that were less than 0.05, hence there was no need for multiplicity adjustment.|Linear mixed effects model|||Analysis was done using a linear mixed effects model including baseline pain, sequence, period, center, and treatment as fixed effect factors and participant within sequence and within-participant error as random factors. Last observation carried forward (LOCF) approach was applied.||0.01|-0.46|0.0659
72369014|NCT01039376|144247978|SUPERIORITY||Hazard Ratio (HR)|4.219|||||TWO_SIDED|95.0|2.468|7.21|||||HR estimated for Cytogenetics Group (based on \>=20% cut-off) with 11q-/no abberation|||7.210|2.468|
72422902|NCT03502616|144356438|SUPERIORITY||LS mean difference|0.33|STANDARD_ERROR_OF_MEAN|0.532||0.534|TWO_SIDED|95.0|-0.73|1.39|||Mixed Models Analysis|||Week 4: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||1.39|-0.73|0.5340
72422903|NCT03502616|144356438|SUPERIORITY||LS mean difference|0.06|STANDARD_ERROR_OF_MEAN|0.582||0.9148|TWO_SIDED|95.0|-1.1|1.22|||Mixed Models Analysis|||Week 8: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||1.22|-1.10|0.9148
72369015|NCT01039376|144247978|SUPERIORITY||Hazard Ratio (HR)|1.832|||||TWO_SIDED|95.0|1.434|2.339|||||HR estimated for B2 Microglobulin Group 2 with 3500 as cut off: \>3500 ug/L/\<=3500 ug/L|||2.339|1.434|
72422904|NCT03502616|144356438|SUPERIORITY||LS mean difference|-0.34|STANDARD_ERROR_OF_MEAN|0.548||0.5409|TWO_SIDED|95.0|-1.43|0.76|||Mixed Models Analysis|||Week 12: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.76|-1.43|0.5409
72422905|NCT03502616|144356438|SUPERIORITY||LS mean difference|-0.57|STANDARD_ERROR_OF_MEAN|0.607||0.3555|TWO_SIDED|95.0|-1.78|0.65|||Mixed Models Analysis|||Week 16: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.65|-1.78|0.3555
72422906|NCT03502616|144356438|SUPERIORITY||LS mean difference|0.51|STANDARD_ERROR_OF_MEAN|0.436||0.2485|TWO_SIDED|95.0|-0.36|1.38|||Mixed Models Analysis|||Week 24: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||1.38|-0.36|0.2485
72422907|NCT03502616|144356438|SUPERIORITY||LS mean difference|0.76|STANDARD_ERROR_OF_MEAN|0.435||0.0866|TWO_SIDED|95.0|-0.11|1.63|||Mixed Models Analysis|||Week 32: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||1.63|-0.11|0.0866
72422908|NCT03502616|144356438|SUPERIORITY||LS mean difference|0.3|STANDARD_ERROR_OF_MEAN|0.356||0.4101|TWO_SIDED|95.0|-0.42|1.01|||Mixed Models Analysis|||Week 40: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||1.01|-0.42|0.4101
72422909|NCT03502616|144356438|SUPERIORITY||LS mean difference|0.5|STANDARD_ERROR_OF_MEAN|0.217||0.0237|TWO_SIDED|95.0|0.07|0.94|||Mixed Models Analysis|||Week 48: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.94|0.07|0.0237
72422910|NCT03502616|144356439|SUPERIORITY||LS mean difference|0.31|STANDARD_ERROR_OF_MEAN|0.107||0.0043|TWO_SIDED|95.0|0.1|0.52|||Mixed Models Analysis|||Week 2: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.52|0.10|0.0043
72422911|NCT03502616|144356439|SUPERIORITY||LS mean difference|0.33|STANDARD_ERROR_OF_MEAN|0.121||0.0072|TWO_SIDED|95.0|0.09|0.56|||Mixed Models Analysis|||Week 4: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.56|0.09|0.0072
72422912|NCT03502616|144356439|SUPERIORITY||LS mean difference|0.23|STANDARD_ERROR_OF_MEAN|0.146||0.1101|TWO_SIDED|95.0|-0.05|0.52|||Mixed Models Analysis|||Week 8: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.52|-0.05|0.1101
72422913|NCT03502616|144356439|SUPERIORITY||LS mean difference|0.32|STANDARD_ERROR_OF_MEAN|0.13||0.0147|TWO_SIDED|95.0|0.06|0.58|||Mixed Models Analysis|||Week 12: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.58|0.06|0.0147
72422914|NCT03502616|144356439|SUPERIORITY||LS mean difference|0.21|STANDARD_ERROR_OF_MEAN|0.162||0.2032|TWO_SIDED|95.0|-0.11|0.53|||Mixed Models Analysis|||Week 16: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.53|-0.11|0.2032
72332488|NCT01474772|144189368|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.291|STANDARD_ERROR_OF_MEAN|0.128||0.0242|TWO_SIDED|95.0|-0.543|-0.038||Primary analysis was two-sided and performed at the 0.05 significance level. Unstructured covariance structure was used to estimate the within-participant errors.|Repeated measure mixed effects model|The Kenward-Roger method was used to estimate denominator degrees of freedom.||This longitudinal analysis was a sensitivity analysis of the primary endpoint. P-value was based on a repeated measure mixed effects model including pooled center, time point, treatment, an indicator variable for Week 6 as well as interaction terms as fixed effect factors. For analysis purpose, it is assumed that participants were on placebo at Baseline, took the same treatment as in Period 1 during Week 1 of washout, and were on placebo in Week 2 of washout.||-0.038|-0.543|0.0242
72332489|NCT01474772|144189369|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.13|STANDARD_ERROR_OF_MEAN|0.16||0.412|TWO_SIDED|95.0|-0.44|0.18||Primary analysis was two-sided and performed at the 0.05 significance level. The study was considered positive only if both co-primary endpoints have p-values that are less than 0.05, hence there was no need for multiplicity adjustment.|Mixed-Effect Model Repeated Measures|Satterthwaite's approximation was used to estimate denominator degrees of freedom.||Analysis was done using a repeated measure linear mixed effects model including baseline pain, sequence, period, center, time, treatment, and treatment by time interaction as fixed effect factors and participant within sequence and within-participant error as random factors. The model term 'time' may take 2 values corresponding to Week 3 and Week 6 in each period.||0.18|-0.44|0.4120
72332490|NCT01474772|144189370|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.55||||0.0847|TWO_SIDED|95.0|0.94|2.55||Secondary analysis was two-sided and performed at the 0.05 significance level. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.|Generalized linear mixed model|||Analysis was done overall (period 1 and period 2) using a generalized linear mixed model which included response as the dependent variable, sequence, period, pooled center, treatment as fixed effects, and subject within treatment as random effect. LOCF approach was applied.||2.55|0.94|0.0847
72332491|NCT01474772|144189371|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.38||||0.2459|TWO_SIDED|95.0|0.8|2.39||Secondary analysis was two-sided and performed at the 0.05 significance level. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.|Generalized linear mixed model|||Analysis was done overall (period 1 and period 2) using a generalized linear mixed model which included response as the dependent variable, sequence, period, pooled center, treatment as fixed effects, and subject within treatment as random effect. LOCF approach was applied.||2.39|0.80|0.2459
72332492|NCT01474772|144189372|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.8|STANDARD_ERROR_OF_MEAN|0.46||0.0889|TWO_SIDED|95.0|-1.71|0.12||Secondary analysis was two-sided and performed at the 0.05 significance level. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.|Linear mixed effects model|||Analysis was done using a linear mixed effects model including baseline pain, sequence, period, center, and treatment as fixed effect factors and participant within sequence and within-participant error as random factors.||0.12|-1.71|0.0889
72332493|NCT01474772|144189373|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.16|STANDARD_ERROR_OF_MEAN|0.86||0.1781|TWO_SIDED|95.0|-2.86|0.53||Secondary analysis was two-sided and performed at the 0.05 significance level. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.|Linear mixed effects model|||Analysis was done using a linear mixed effects model including baseline pain, sequence, period, center, and treatment as fixed effect factors and participant within sequence and within-participant error as random factors.||0.53|-2.86|0.1781
72332494|NCT01474772|144189374|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.19|STANDARD_ERROR_OF_MEAN|0.17||0.2719|TWO_SIDED|95.0|-0.53|0.15||Secondary analysis was two-sided and performed at the 0.05 significance level. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.|Linear mixed effects model|||Analysis was done using a linear mixed effects model including baseline pain, sequence, period, center, and treatment as fixed effect factors and participant within sequence and within-participant error as random factors.||0.15|-0.53|0.2719
72332495|NCT01474772|144189375|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|563.39|STANDARD_ERROR_OF_MEAN|4098.74||0.8909|TWO_SIDED|95.0|-7549.82|8676.6||Secondary analysis was two-sided and performed at the 0.05 significance level. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.|Linear mixed effects model|||Analysis was done using a linear mixed effects model including baseline value, sequence, period, center, and treatment as fixed effect factors and participant within sequence and within-participant error as random factors. LOCF approach was applied.||8676.60|-7549.82|0.8909
72332496|NCT01474772|144189376|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.63|STANDARD_ERROR_OF_MEAN|206.37||0.9899|TWO_SIDED|95.0|-411.26|406.01||Secondary analysis was two-sided and performed at the 0.05 significance level. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.|Linear mixed effects model|||Analysis was done using a linear mixed effects model including baseline value, sequence, period, center, and treatment as fixed effect factors and participant within sequence and within-participant error as random factors. LOCF approach was applied.||406.01|-411.26|0.9899
72332497|NCT01474772|144189377|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.37|STANDARD_ERROR_OF_MEAN|1.27||0.2854|TWO_SIDED|95.0|-3.88|1.15||Secondary analysis was two-sided and performed at the 0.05 significance level. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.|Linear mixed effects model|||Analysis was done using a linear mixed effects model including baseline value, sequence, period, center, and treatment as fixed effect factors and participant within sequence and within-participant error as random factors.||1.15|-3.88|0.2854
72369016|NCT01039376|144247978|SUPERIORITY||Hazard Ratio (HR)|0.573|||||TWO_SIDED|95.0|0.432|0.76|||||HR estimated for IgVH Mutational Status 1 Mutated/Unmutated|||0.760|0.432|
72369017|NCT01039376|144247978|SUPERIORITY||Hazard Ratio (HR)|1.301|||||TWO_SIDED|95.0|0.692|2.448|||||HR estimated for VH3-21 Usage Flag Yes/No.|||2.448|0.692|
72369018|NCT04555616|144247989|OTHER|||||||0.12|||||||Fisher Exact|||Primary outcome analyzed via success rates among groups.||||0.12
72422915|NCT03502616|144356439|SUPERIORITY||LS mean difference|-0.01|STANDARD_ERROR_OF_MEAN|0.168||0.9345|TWO_SIDED|95.0|-0.34|0.32|||Mixed Models Analysis|||Week 24: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.32|-0.34|0.9345
72422916|NCT03502616|144356439|SUPERIORITY||LS mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.187||0.5968|TWO_SIDED|95.0|-0.47|0.27|||Mixed Models Analysis|||Week 32: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.27|-0.47|0.5968
72422917|NCT03502616|144356439|SUPERIORITY||LS mean difference|0.06|STANDARD_ERROR_OF_MEAN|0.166||0.7047|TWO_SIDED|95.0|-0.26|0.39|||Mixed Models Analysis|||Week 40: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.39|-0.26|0.7047
72422918|NCT03502616|144356439|SUPERIORITY||LS mean difference|0.04|STANDARD_ERROR_OF_MEAN|0.157||0.807|TWO_SIDED|95.0|-0.27|0.35|||Mixed Models Analysis|||Week 48: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.35|-0.27|0.8070
72422919|NCT03502616|144356440|SUPERIORITY||LS mean difference|-0.17|STANDARD_ERROR_OF_MEAN|0.055||0.003|TWO_SIDED|95.0|-0.28|-0.06|||ANCOVA|||Week 16, Mobility: Analysis performed using ANCOVA model which included fixed effects of treatment group, stratification factor derived from clinical database, and baseline value.||-0.06|-0.28|0.0030
72422920|NCT03502616|144356440|SUPERIORITY||LS mean difference|-0.01|STANDARD_ERROR_OF_MEAN|0.055||0.897|TWO_SIDED|95.0|-0.11|0.1|||ANCOVA|||Week 16, Self-Care: Analysis performed using ANCOVA model which included fixed effects of treatment group, stratification factor derived from clinical database, and baseline value.||0.10|-0.11|0.8970
72422921|NCT03502616|144356440|SUPERIORITY||LS mean difference|-0.09|STANDARD_ERROR_OF_MEAN|0.058||0.1437|TWO_SIDED|95.0|-0.2|0.03|||ANCOVA|||Week 16, Usual Activities: Analysis performed using ANCOVA model which included fixed effects of treatment group, stratification factor derived from clinical database, and baseline value.||0.03|-0.20|0.1437
72422922|NCT03502616|144356440|SUPERIORITY||LS mean difference|-0.18|STANDARD_ERROR_OF_MEAN|0.046|<|0.0001|TWO_SIDED|95.0|-0.27|-0.09|||ANCOVA|||Week 16, Pain/Discomfort: Analysis performed using ANCOVA model which included fixed effects of treatment group, stratification factor derived from clinical database, and baseline value.||-0.09|-0.27|<0.0001
72422923|NCT03502616|144356440|SUPERIORITY||LS mean difference|-0.01|STANDARD_ERROR_OF_MEAN|0.061||0.8445|TWO_SIDED|95.0|-0.13|0.11|||ANCOVA|||Week 16, Anxiety/Depression: Analysis performed using ANCOVA model which included fixed effects of treatment group, stratification factor derived from clinical database, and baseline value.||0.11|-0.13|0.8445
72332498|NCT01474772|144189378|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.46|STANDARD_ERROR_OF_MEAN|1.09||0.1805|TWO_SIDED|95.0|-3.6|0.68||Secondary analysis was two-sided and performed at the 0.05 significance level. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.|Linear mixed effects model|||Analysis was done using a linear mixed effects model including baseline value, sequence, period, center, and treatment as fixed effect factors and participant within sequence and within-participant error as random factors.||0.68|-3.60|0.1805
72422924|NCT03502616|144356440|SUPERIORITY||LS mean difference|-0.06|STANDARD_ERROR_OF_MEAN|0.064||0.3473|TWO_SIDED|95.0|-0.19|0.07|||Mixed Models Analysis|||Week 48, Mobility: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.07|-0.19|0.3473
72422925|NCT03502616|144356440|SUPERIORITY||LS mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.059||0.9834|TWO_SIDED|95.0|-0.12|0.12|||Mixed Models Analysis|||Week 48, Self-Care: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.12|-0.12|0.9834
72422926|NCT03502616|144356440|SUPERIORITY||LS mean difference|0.02|STANDARD_ERROR_OF_MEAN|0.066||0.7364|TWO_SIDED|95.0|-0.11|0.15|||Mixed Models Analysis|||Week 48, Usual Activities: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.15|-0.11|0.7364
72422927|NCT03502616|144356440|SUPERIORITY||LS mean difference|-0.01|STANDARD_ERROR_OF_MEAN|0.059||0.8075|TWO_SIDED|95.0|-0.13|0.1|||Mixed Models Analysis|||Week 48, Pain/Discomfort: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.10|-0.13|0.8075
72422928|NCT03502616|144356440|SUPERIORITY||LS mean difference|0.04|STANDARD_ERROR_OF_MEAN|0.067||0.5461|TWO_SIDED|95.0|-0.09|0.17|||Mixed Models Analysis|||Week 48, Anxiety/Depression: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.17|-0.09|0.5461
72332499|NCT01474772|144189379|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.34|STANDARD_ERROR_OF_MEAN|0.33||0.3028|TWO_SIDED|95.0|-0.99|0.31||Secondary analysis was two-sided and performed at the 0.05 significance level. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.|Linear mixed effects model|||Analysis was done using a linear mixed effects model including baseline value, sequence, period, center, and treatment as fixed effect factors and participant within sequence and within-participant error as random factors.||0.31|-0.99|0.3028
72422929|NCT03502616|144356441|SUPERIORITY||LS mean difference|10.11|STANDARD_ERROR_OF_MEAN|2.331|<|0.0001|TWO_SIDED|95.0|5.52|14.7|||ANCOVA|||Week 16: Analysis performed using ANCOVA model which included fixed effects of treatment group, stratification factor derived from clinical database, and baseline value.||14.70|5.52|<0.0001
72422930|NCT03502616|144356441|SUPERIORITY||LS mean difference|2.63|STANDARD_ERROR_OF_MEAN|2.337||0.2608|TWO_SIDED|95.0|-1.97|7.24|||Mixed Models Analysis|||Week 48: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||7.24|-1.97|0.2608
72422931|NCT03502616|144356442|SUPERIORITY||LS mean difference|-4.53|STANDARD_ERROR_OF_MEAN|3.35||0.1784|TWO_SIDED|95.0|-11.15|2.09|||ANCOVA|||Week 16: Analysis performed using ANCOVA model which included fixed effects of treatment group, stratification factor derived from clinical database, and baseline value.||2.09|-11.15|0.1784
72422932|NCT03502616|144356442|SUPERIORITY||LS mean difference|-2.31|STANDARD_ERROR_OF_MEAN|2.54||0.3651|TWO_SIDED|95.0|-7.34|2.72|||Mixed Models Analysis|||Week 48: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||2.72|-7.34|0.3651
72422933|NCT03502616|144356443|SUPERIORITY||LS mean difference|-12.89|STANDARD_ERROR_OF_MEAN|2.884|<|0.0001|TWO_SIDED|95.0|-18.59|-7.19|||ANCOVA|||Week 16: Analysis performed using ANCOVA model which included fixed effects of treatment group, stratification factor derived from clinical database, and baseline value.||-7.19|-18.59|<0.0001
72422934|NCT03502616|144356443|SUPERIORITY||LS mean difference|-2.36|STANDARD_ERROR_OF_MEAN|3.318||0.4788|TWO_SIDED|95.0|-8.92|4.21|||Mixed Models Analysis|||Week 48: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||4.21|-8.92|0.4788
72422935|NCT03502616|144356444|SUPERIORITY||LS mean difference|-13.85|STANDARD_ERROR_OF_MEAN|3.202|<|0.0001|TWO_SIDED|95.0|-20.18|-7.52|||ANCOVA|||Week 16: Analysis performed using ANCOVA model which included fixed effects of treatment group, stratification factor derived from clinical database, and baseline value.||-7.52|-20.18|<0.0001
72422936|NCT03502616|144356444|SUPERIORITY||LS mean difference|-4.41|STANDARD_ERROR_OF_MEAN|3.613||0.2244|TWO_SIDED|95.0|-11.56|2.74|||Mixed Models Analysis|||Week 48: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||2.74|-11.56|0.2244
72422937|NCT03502616|144356445|SUPERIORITY||LS mean difference|-13.4|STANDARD_ERROR_OF_MEAN|2.488|<|0.0001|TWO_SIDED|95.0|-18.3|-8.5|||ANCOVA|||Week 16: Analysis performed using ANCOVA model which included fixed effects of treatment group, stratification factor derived from clinical database, and baseline value.||-8.50|-18.30|<0.0001
72422938|NCT03502616|144356445|SUPERIORITY||LS mean difference|-7.6|STANDARD_ERROR_OF_MEAN|2.905||0.0095|TWO_SIDED|95.0|-13.32|-1.88|||Mixed Models Analysis|||Week 48: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-1.88|-13.32|0.0095
72422939|NCT03315936|144356449|OTHER||geometric mean (gMean) ratio (T/R) %|110.31|||||TWO_SIDED|90.0|100.73|120.79|||||To get, gMean ratio (T/R) and confidence interval, least square estimates of log-transformed PK endpoint for T and R were back transformed to original scale. Intra-individual geometric coefficient of variation (%) = 12.3.|The analysis of variance (ANOVA) model on the logarithmic scale including 'sequence', 'period', and 'treatment' as fixed effects and 'subject within sequence' as random effect. No hypothesis was tested and no acceptance range was specified. This was an intra-individual assessment and actually 12 subjects were analyzed||120.79|100.73|
72422940|NCT03315936|144356450|OTHER||gMean ratio (T/R) %|110.83|||||TWO_SIDED|90.0|101.2|121.38|||||To get, gMean ratio (T/R) and confidence interval, least square estimates of log-transformed PK endpoint for T and R were back transformed to original scale. Intra-individual geometric coefficient of variation (%) = 12.3.|The analysis of variance (ANOVA) model on the logarithmic scale including 'sequence', 'period', and 'treatment' as fixed effects and 'subject within sequence' as random effect. No hypothesis was tested and no acceptance range was specified. This was an intra-individual assessment and actually only 12 subjects were analyzed.||121.38|101.20|
72422941|NCT03315936|144356451|OTHER||gMean ratio (T/R) %|110.46|||||TWO_SIDED|90.0|89.74|135.96|||||To get, gMean ratio (T/R) and confidence interval, least square estimates of log-transformed PK endpoint for T and R were back transformed to original scale. Intra-individual geometric coefficient of variation (%) = 28.6.|The analysis of variance (ANOVA) model on the logarithmic scale including 'sequence', 'period', and 'treatment' as fixed effects and 'subject within sequence' as random effect. No hypothesis was tested and no acceptance range was specified. This was an intra-individual assessment and actually only 12 subjects were analyzed.||135.96|89.74|
72332500|NCT01474772|144189380|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.06|STANDARD_ERROR_OF_MEAN|0.18||0.7542|TWO_SIDED|95.0|-0.41|0.3||Secondary analysis was two-sided and performed at the 0.05 significance level. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.|Linear mixed effects model|||Analysis was done using a linear mixed effects model including baseline value, sequence, period, center, and treatment as fixed effect factors and participant within sequence and within-participant error as random factors.||0.30|-0.41|0.7542
72422942|NCT00770432|144356464|SUPERIORITY_OR_OTHER|||||||0.0595||95.0|||||Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel adjusted for study site (the smallest study sites were pooled according to a pre-specified rule).||||||0.0595
72422943|NCT00818363|144356465|SUPERIORITY||LS Mean Difference|-0.64||||0.303|TWO_SIDED|95.0|-1.74|0.47|||ANCOVA|Includes treatment group and trial site as factors and age as a covariate.||||0.47|-1.74|0.303
72422944|NCT00818363|144356466|SUPERIORITY||LS Mean Difference|-10.25||||0.303|TWO_SIDED|95.0|-30.04|9.55|||ANCOVA|Includes treatment group and trial site as factors and age as a covariate.||||9.55|-30.04|0.303
72422945|NCT00988221|144356494|SUPERIORITY_OR_OTHER||Adjusted mean - Placebo|-22.3||||||||||The analysis was adjusted for the randomization stratification factors background use of methotrexate and background use of oral corticosteroids. The analysis was also adjusted for the pain visual analog scale score at Baseline.|ANOVA|||||||
72422946|NCT00988221|144356494|SUPERIORITY_OR_OTHER||Adjusted mean - Tocilizumab|-32.4||||||||||The analysis was adjusted for the randomization stratification factors background use of methotrexate and background use of oral corticosteroids. The analysis was also adjusted for the pain visual analog scale score at Baseline.|ANOVA|||||||
72422947|NCT00988221|144356494|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.2||||0.0076|TWO_SIDED|95.0|-17.6|-2.7||The analysis was adjusted for the randomization stratification factors background use of methotrexate and background use of oral corticosteroids. The analysis was also adjusted for the pain visual analog scale score at Baseline.|ANOVA|||||-2.7|-17.6|0.0076
72422948|NCT00988221|144356495|SUPERIORITY_OR_OTHER||Weighted difference|18.0||||1|TWO_SIDED|95.0|5.0|32.0||1.000 is used here as the test was considered as not significant due to the break in the hierarchical testing chain.|Cochran-Mantel-Haenszel|The analysis was adjusted for the randomization stratification factors background use of methotrexate and background use of oral corticosteroids.||The analysis used the Cochran-Mantel-Haenszel test adjusted for the randomization stratification factors background use of methotrexate and background use of oral corticosteroids.||32|5|1.000
72422949|NCT00633919|144356514|SUPERIORITY_OR_OTHER|||||||0.85|TWO_SIDED|95.0|||||Linear mixed effect (LME) model|||The null hypothesis is the hypothesis of no difference and the alternative to the null hypothesis is the hypothesis of a difference.||||0.85
72422950|NCT00633919|144356515|SUPERIORITY_OR_OTHER|||||||0.52|TWO_SIDED|95.0|||||Linear mixed effect (LME) model|||The null hypothesis is the hypothesis of no difference and the alternative to the null hypothesis is the hypothesis of a difference.||||0.52
72332501|NCT01474772|144189381|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.27|STANDARD_ERROR_OF_MEAN|0.68||0.0634|TWO_SIDED|95.0|-2.62|0.07||Secondary analysis was two-sided and performed at the 0.05 significance level. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.|Linear mixed effects model|||Analysis was done using a linear mixed effects model including baseline value, sequence, period, center, and treatment as fixed effect factors and participant within sequence and within-participant error as random factors.||0.07|-2.62|0.0634
72422951|NCT00633919|144356516|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||Proportional odds regression|||The null hypothesis is the hypothesis of no difference and the alternative to the null hypothesis is the hypothesis of a difference.||||>0.05
72422952|NCT00633919|144356517|SUPERIORITY_OR_OTHER|||||||0.0486||95.0|||||Proportional odds regression|||The null hypothesis is the hypothesis of no difference and the alternative to the null hypothesis is the hypothesis of a difference.||||0.0486
72422953|NCT00633919|144356518|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||Proportional odds regression|||The null hypothesis is the hypothesis of no difference and the alternative to the null hypothesis is the hypothesis of a difference.||||>0.05
72422954|NCT01991821|144356519|SUPERIORITY|||||||0.093||||||The complete response of the primary efficacy analysis occurred in 95 patients (56.2%; 95% confidence interval \[CI\] 48.4 - 63.8%) in the APD421 group and 83 patients (46.6%; 95% CI 39.1- 54.2%) in the placebo group|Chi-squared, Corrected|Pearson square test with Yates's continuity correction and with the two- sided significance level of 5%||The primary efficacy analysis was a complete response which is defined as protection from PONV1, which was absence of any episode of emesis, significant nausea or use of rescue medication with the first 24 hours post-operatively.||||0.093
72422955|NCT01991821|144356520|SUPERIORITY|||||||0.059||||||Two-sided, significance threshold = 0.05|Chi-squared, Corrected|||||||0.059
72422956|NCT01991821|144356521|SUPERIORITY|||||||0.053||||||Two-sided, significance threshold = 0.05|Chi-squared, Corrected|||||||0.053
72422957|NCT01991821|144356522|SUPERIORITY|||||||0.26||||||Two-sided, significance threshold = 0.05|Chi-squared, Corrected|||||||0.26
72422958|NCT01991821|144356523|SUPERIORITY|||||||0.06||||||Two-sided, significance threshold = 0.05|Chi-squared, Corrected|||||||0.06
72422959|NCT01991821|144356524|SUPERIORITY|||||||0.079||||||Two-sided, significance threshold = 0.05|Chi-squared, Corrected|||||||0.079
72422960|NCT01991821|144356525|SUPERIORITY|||||||0.096|||||||Chi-squared, Corrected|||||||0.096
72422961|NCT04203537|144356526|SUPERIORITY|||||||0.0004|||||||ANOVA|||||||0.0004
72422962|NCT04203537|144356527|SUPERIORITY||||||<|0.0001|||||||ANOVA|||||||<0.0001
72422963|NCT04203537|144356527|SUPERIORITY|||||||0.0026|||||||ANOVA|||||||0.0026
72422964|NCT04581200|144356528|SUPERIORITY||Mean Difference (Final Values)|0.59||||0.61|TWO_SIDED|95.0|-1.63|2.8|||t-test, 2 sided|||||2.80|-1.63|0.61
72422965|NCT04581200|144356529|OTHER|This is an exploratory pilot trial|Mean Difference (Final Values)|0.21||||0.89|TWO_SIDED|95.0|-2.66|3.08|||t-test, 2 sided|||||3.08|-2.66|0.89
72422966|NCT04581200|144356530|SUPERIORITY||Mean Difference (Final Values)|0.36||||0.81|TWO_SIDED|95.0|-2.58|3.3|||t-test, 2 sided|||||3.30|-2.58|0.81
72422967|NCT04581200|144356531|SUPERIORITY||Mean Difference (Final Values)|-0.42||||0.75|TWO_SIDED|95.0|-2.98|2.14|||t-test, 2 sided|||||2.14|-2.98|0.75
72422968|NCT04581200|144356532|SUPERIORITY||Mean Difference (Final Values)|0.09||||0.45|TWO_SIDED|95.0|-0.57|0.74|||t-test, 2 sided|||||0.74|-0.57|0.45
72422969|NCT04581200|144356533|SUPERIORITY||Mean Difference (Final Values)|0.002||||0.98|TWO_SIDED|95.0|-0.13|0.13|||t-test, 2 sided|||||0.13|-0.13|0.98
72422970|NCT04581200|144356534|SUPERIORITY|||||||0.08|||||||Fisher Exact|||||||0.08
72422971|NCT04581200|144356535|SUPERIORITY|||||||0.69|||||||Fisher Exact|||||||0.69
72369019|NCT04816669|144247992|NON_INFERIORITY|Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR is greater than 0.67.|Geometric mean ratio|0.68|||||TWO_SIDED|95.0|0.6|0.77|||||GMRs and 2-sided 95% CIs were calculated by exponentiating the mean difference of the logarithms of the concentrations BNT162b2 lyophilized SDV - BNT162b2 frozen-liquid MDV and the corresponding CI (based on the Student t distribution).|||0.77|0.60|
72369020|NCT04816669|144248000|NON_INFERIORITY|Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR is greater than 0.67|Geometric mean ratio|1.14|||||TWO_SIDED|95.0|0.77|1.68|||||GMRs and 2-sided 95% CIs were calculated by exponentiating the mean difference of the logarithms of the concentrations BNT162b2 frozen-liquid LNP - BNT162b2 frozen-liquid RTU and the corresponding CI (based on the Student t distribution).|||1.68|0.77|
72369021|NCT01229267|144248008|SUPERIORITY||Vaccine Efficacy|0.638|||||TWO_SIDED|95.0|0.484|0.746|||||Point estimate and 95% CI of vaccine efficacy were obtained from a Cox proportional hazards regression model, adjusting for age (\<50 versus ≥50 years of age), and intended duration of antiviral prophylaxis (≤3 versus 3 to 6 months after auto-HCT).|Vaccine efficacy was calculated as 1 minus the hazard ratio of HZ in the V212 consistency lot group versus the placebo group. The success criterion for vaccine efficacy required that the lower bound of the 95% confidence interval (CI) is \>0.25.||0.746|0.484|
72369022|NCT01229267|144248009|OTHER||Vaccine Efficacy|0.695|||||TWO_SIDED|95.0|0.49|0.818|||||Point estimate and 95% CI of vaccine efficacy were obtained from a Cox proportional hazards regression model, adjusting for age (\<50 versus ≥50 years of age), and intended duration of antiviral prophylaxis (≤3 versus 3 to 6 months after auto-HCT).|Vaccine efficacy was calculated as 1 minus the hazard ratio of HZ in the V212 consistency lot group versus the placebo group. The success criterion for vaccine efficacy required that the lower bound of the 95% CI is \>0.25.||0.818|0.490|
72369023|NCT01229267|144248010|OTHER||Vaccine Efficacy|0.735|||||TWO_SIDED|95.0|0.498|0.86|||||Point estimate and 95% CI of vaccine efficacy were obtained from a Cox proportional hazards regression model, adjusting for age (\<50 versus ≥50 years of age), and intended duration of antiviral prophylaxis (≤3 versus 3 to 6 months after auto-HCT).|Vaccine efficacy was calculated as 1 minus the hazard ratio of HZ in the V212 consistency lot group versus the placebo group. The success criterion for vaccine efficacy required that the lower bound of the 95% CI is \>0.25.||0.860|0.498|
72369024|NCT01229267|144248011|OTHER||Vaccine Efficacy|0.837|||||TWO_SIDED|95.0|0.446|0.952|||||Point estimate and 95% CI of vaccine efficacy were obtained from a Cox proportional hazards regression model, adjusting for age (\<50 versus ≥50 years of age), and intended duration of antiviral prophylaxis (≤3 versus 3 to 6 months after auto-HCT).|Vaccine efficacy was calculated as 1 minus the hazard ratio of HZ in the V212 consistency lot group versus the placebo group. The success criterion for vaccine efficacy required that the lower bound of the 95% CI is \>0.25.||0.952|0.446|
72369025|NCT01229267|144248012|OTHER||Risk Difference (RD)|0.2||||0.942|TWO_SIDED|95.0|-5.1|5.5|||Normal approximation||Miettinen \& Nurminen|||5.5|-5.1|0.942
72369026|NCT02446899|144248015|SUPERIORITY|The difference in estimates and associated 95% CI are weighted and are calculated using a stratified Cochran-Mantel-Haenszel (CMH) approach, with stratification factors (SLEDAI-2K score at screening \[\<10 points vs \>= 10 points\], Week 0 OCS dose \[\<10 mg/day vs \>=10 mg/day prednisone or equivalent\] and type I IFN gene signature test result at screening \[high vs low\]).|Mean Difference (Final Values)|16.3||||0.0013|TWO_SIDED|95.0|6.3|26.3||Nominal p-value.|Cochran-Mantel-Haenszel|||||26.3|6.3|0.0013
72369027|NCT02446899|144248016|SUPERIORITY||Mean Difference (Final Values)|17.3||||0.0022|TWO_SIDED|95.0|6.5|28.2||Adjusted p-value.|Cochran-Mantel-Haenszel|||The difference in estimates and associated 95% CI are weighted and are calculated using a stratified Cochran-Mantel-Haenszel (CMH) approach, with stratification factors (SLEDAI-2K score at screening \[\<10 points vs \>= 10 points\], Week 0 OCS dose \[\<10 mg/day vs \>=10 mg/day prednisone or equivalent\] and type I IFN gene signature test result at screening \[high vs low\]).||28.2|6.5|0.0022
72369028|NCT02446899|144248017|SUPERIORITY||Mean Difference (Final Values)|21.2||||0.0135|TWO_SIDED|95.0|6.8|35.7||Adjusted p-value.|Cochran-Mantel-Haenszel|||The difference in estimates and associated 95% CI are weighted and are calculated using a stratified Cochran-Mantel-Haenszel (CMH) approach, with stratification factors (SLEDAI-2K score at screening \[\<10 points vs \>= 10 points\], Week 0 OCS dose \[\<10 mg/day vs \>=10 mg/day prednisone or equivalent\] and type I IFN gene signature test result at screening \[high vs low\]).||35.7|6.8|0.0135
72369029|NCT02446899|144248018|SUPERIORITY||Mean Difference (Final Values)|24.0||||0.0392|TWO_SIDED|95.0|4.3|43.6||Adjusted p-value.|Cochran-Mantel-Haenszel|||The difference in estimates and associated 95% CI are weighted and are calculated using a stratified Cochran-Mantel-Haenszel (CMH) approach, with stratification factors (SLEDAI-2K score at screening \[\<10 points vs \>= 10 points\], Week 0 OCS dose \[\<10 mg/day vs \>=10 mg/day prednisone or equivalent\] and type I IFN gene signature test result at screening \[high vs low\]).||43.6|4.3|0.0392
72369030|NCT02446899|144248019|SUPERIORITY||Mean Difference (Final Values)|4.7||||0.5469|TWO_SIDED|95.0|-10.6|20.0||Adjusted p-value|Cochran-Mantel-Haenszel|||The difference in estimates and associated 95% CI are weighted and are calculated using a stratified Cochran-Mantel-Haenszel (CMH) approach, with stratification factors (SLEDAI-2K score at screening \[\<10 points vs \>= 10 points\], Week 0 OCS dose \[\<10 mg/day vs \>=10 mg/day prednisone or equivalent\] and type I IFN gene signature test result at screening \[high vs low\]).||20.0|-10.6|0.5469
72422972|NCT01625923|144356540|OTHER|T-test comparing GCSI-DD scores before/after intervention||||||0.06|||||||t-test, 2 sided|||||||.06
72332502|NCT01474772|144189382|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.24|STANDARD_ERROR_OF_MEAN|0.19||0.1985|TWO_SIDED|95.0|-0.13|0.62||Secondary analysis was two-sided and performed at the 0.05 significance level. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.|Linear mixed effects model|||Analysis was done using a linear mixed effects model including baseline value, sequence, period, center, and treatment as fixed effect factors and participant within sequence and within-participant error as random factors.||0.62|-0.13|0.1985
72332503|NCT01474772|144189383|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.1||0.9686|TWO_SIDED|95.0|-0.21|0.2||Secondary analysis was two-sided and performed at the 0.05 significance level. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.|Linear mixed effects model|||Analysis was done using a linear mixed effects model including baseline value, sequence, period, center, and treatment as fixed effect factors and participant within sequence and within-participant error as random factors.||0.20|-0.21|0.9686
72332504|NCT01474772|144189384|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.54||||0.002|TWO_SIDED|95.0|1.3|4.95|||Cochran-Mantel-Haenszel|||Odds ratio is based on the binary response for any improvement while p-value is from the comparison of the original scale of 7 possible outcomes. P-value was calculated by using Cochran Mantel-Haenszel (CMH) test. PGIC values at the end of Period 1 data was compared between treatment groups.||4.95|1.30|0.0020
72332505|NCT01474772|144189385|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.38|STANDARD_ERROR_OF_MEAN|0.15||0.0105|TWO_SIDED|95.0|-0.68|-0.09||Secondary analysis was two-sided and performed at the 0.05 significance level. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.|Linear mixed effects model|||Analysis was done using a linear mixed effects model including baseline value, sequence, period, center, and treatment as fixed effect factors and participant within sequence and within-participant error as random factors. LOCF approach was applied.||-0.09|-0.68|0.0105
72332506|NCT01474772|144189386|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.28|STANDARD_ERROR_OF_MEAN|0.18||0.1178|TWO_SIDED|95.0|-0.63|0.07||Secondary analysis was two-sided and performed at the 0.05 significance level. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.|Linear mixed effects model|||Analysis was done using a linear mixed effects model including baseline value, sequence, period, center, and treatment as fixed effect factors and participant within sequence and within-participant error as random factors.||0.07|-0.63|0.1178
72332507|NCT01474772|144189387|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.24|STANDARD_ERROR_OF_MEAN|0.18||0.199|TWO_SIDED|95.0|-0.6|0.13||Secondary analysis was two-sided and performed at the 0.05 significance level. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.|Linear mixed effects model|||Analysis was done using a linear mixed effects model including baseline value, sequence, period, center, and treatment as fixed effect factors and participant within sequence and within-participant error as random factors.||0.13|-0.60|0.1990
72332508|NCT01474772|144189388|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.006|STANDARD_ERROR_OF_MEAN|0.02||0.71107|TWO_SIDED|95.0|-0.025|0.037||Secondary analysis was two-sided and performed at the 0.05 significance level. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.|Linear mixed effects model|||Statistical analysis presented above is for the Index score Dolan 1997. Analysis was done using a linear mixed effects model including baseline value, sequence, period, center, and treatment as fixed effect factors and participant within sequence and within-participant error as random factors.||0.037|-0.025|0.71107
72332509|NCT01474772|144189388|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.009|STANDARD_ERROR_OF_MEAN|0.02||0.53965|TWO_SIDED|95.0|-0.021|0.039||Secondary analysis was two-sided and performed at the 0.05 significance level. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.|Linear mixed effects model|||Statistical analysis presented above is for the Index score Dolan 2001. Analysis was done using a linear mixed effects model including baseline value, sequence, period, center, and treatment as fixed effect factors and participant within sequence and within-participant error as random factors.||0.039|-0.021|0.53965
72332510|NCT03458910|144189404|SUPERIORITY|||||||0.782|||||||ANOVA|||A 2 (time: pre, post) X 2 (condition: HRV-increase, HRV-decrease) ANOVA was performed.||||0.782
72332511|NCT03458910|144189405|SUPERIORITY|||||||0.48|||||||ANOVA|||A 2 (time: pre, post) X 2 (condition: HRV-increase, HRV-decrease) ANOVA was performed.||||0.480
72422973|NCT01859793|144356551|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||Primary and secondary outcome variables were compared across measurement periods by repeated measures ANOVA and post hoc analyses using Tukey's test were applied if significant differences were detected. A priori sample size calculation demonstrated our study design has 80% power to detect a 1.5% absolute increase in FMD% with 30 subjects completing the entire study protocol at α=0.05.||||<0.05
72422974|NCT01859793|144356552|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||Outcome variables were compared across measurement periods by repeated measures ANOVA and post hoc analyses using Tukey's test were applied if significant differences were detected||||<0.05
72422975|NCT01859793|144356553|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||Outcome variables were compared across measurement periods by repeated measures ANOVA and post hoc analyses using Tukey's test were applied if significant differences were detected||||<0.05
72332512|NCT03458910|144189406|SUPERIORITY|||||||0.41|||||||t-test, 2 sided|||An independent t-test was performed to compare the two groups.||||0.410
72332513|NCT03458910|144189407|SUPERIORITY|||||||0.48|||||||t-test, 2 sided|||An independent t-test was performed to compare the two groups.||||0.480
72332514|NCT03458910|144189408|SUPERIORITY|||||||0.17|||||||ANOVA|||time x condition x regulation goal interaction in behavioral emotional intensity rating for younger adults||||0.170
72422976|NCT00125593|144356579|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.83||||0.0021|TWO_SIDED|95.0|0.74|0.94|||Log Rank|||All analyses by intention to treat||0.94|0.74|0.0021
72422977|NCT00125593|144356580|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.85||||0.0012|TWO_SIDED|95.0|0.77|0.94|||Log Rank|||All analyses by intention to treat||0.94|0.77|0.0012
72422978|NCT00125593|144356581|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.84||||0.001|TWO_SIDED|95.0|0.75|0.93|||Log Rank|||All analyses by intention to treat||0.93|0.75|0.001
72422979|NCT00125593|144356582|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.92||||0.37|TWO_SIDED|95.0|0.76|1.11|||Log Rank|||All analyses by intention to treat||1.11|0.76|0.37
72422980|NCT00125593|144356583|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.75||||0.01|TWO_SIDED|95.0|0.6|0.94|||Log Rank|||All analyses by intention to treat||0.94|0.60|0.01
72422981|NCT00125593|144356584|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.79||||0.0036|TWO_SIDED|95.0|0.68|0.93|||Log Rank|||All analyses by intention to treat||0.93|0.68|0.0036
72422982|NCT00125593|144356585|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.97||||0.41|TWO_SIDED|95.0|0.89|1.05|||Log Rank|||All analyses by intention to treat||1.05|0.89|0.41
72422983|NCT01597505|144356586|NON_INFERIORITY|Surotomycin minus Vancomycin. For surotomycin to be non-inferior to vancomycin the lower bound of a 2-sided 95% CI for the difference between treatment groups had to be ≥ -10%.|Difference in percentage of participants|-4.6|||||TWO_SIDED|95.0|-11.0|1.9|||||The 95% confidence interval (CI) were stratified Wilson intervals for the treatment group percentages and a stratified Newcombe interval for the treatment difference, constructed using the MRc stratum weights.|Difference in percentage of participants||1.9|-11.0|
72422984|NCT01597505|144356587|SUPERIORITY|||||||0.832||||||Log-rank test of equality of survival times, stratified by age group (\< 75, \>= 75 years) and number of CDAD episodes (0, \>= 1). Significance cut-off = 0.05|Log Rank|||Stratified log-rank test p-value||||0.832
72422985|NCT01597505|144356588|SUPERIORITY|Surotomycin - Vancomycin. For surotomycin to be considered superior to vancomycin the lower bound of the 2-sided 95% CI had to be \> 0%.|Difference in percentage of participants|-0.8|||||TWO_SIDED|95.0|-8.8|7.1|||||The 95% CI was stratified Wilson intervals for group percentages and a stratified Newcombe interval for the difference, using the MRc stratum weights. Stratified by age group and number of CDAD episodes.|Difference in percentage of participants||7.1|-8.8|
72422986|NCT01597505|144356592|SUPERIORITY|Surotomycin - Vancomycin. For surotomycin to be considered superior to vancomycin the lower bound of the 2-sided 95% CI had to be \> 0%.|Difference in percentage of participants|0.6|||||TWO_SIDED|95.0|-7.2|8.3|||||The 95% CI was stratified Wilson intervals for group percentages and a stratified Newcombe interval for the difference, using the MRc stratum weights. Stratified by age group and number of CDAD episodes.|Difference in percentage of participants||8.3|-7.2|
72422987|NCT01597505|144356593|SUPERIORITY|Surotomycin - Vancomycin. For surotomycin to be considered superior to vancomycin the lower bound of the 2-sided 95% CI had to be \> 0%.|Difference in percentage of participants|-3.5|||||TWO_SIDED|95.0|-10.0|3.0|||||The 95% CI was stratified Wilson intervals for group percentages and a stratified Newcombe interval for the difference, using the MRc stratum weights. Stratified by age group and number of CDAD episodes.|Difference in percentage of participants||3.0|-10.0|
72422988|NCT01597505|144356594|SUPERIORITY|Surotomycin was superior to vancomycin if the p-value was less than 0.05||||||0.431||||||Log-rank test of equality of survival times, stratified by age group (\< 75, \>= 75 years) and number of CDAD episodes (0, \>= 1). Significance cut-off = 0.05|Log Rank|||Stratified Log-Rank p-Value||||0.431
72332515|NCT03458910|144189409|SUPERIORITY|||||||0.478|||||||ANOVA|||time x condition x regulation goal interaction in behavioral emotional intensity rating for older adults||||0.478
72332516|NCT03458910|144189410|SUPERIORITY|||||||0.441|||||||ANOVA|||time x condition x regulation goal (2 x 2 x 3) interaction effect in the left amygdala for younger adults||||0.441
72332517|NCT03458910|144189411|SUPERIORITY|||||||0.621|||||||ANOVA|||time x condition x regulation goal (2 x 2 x 3) interaction effect in the left amygdala for older adults||||0.621
72332518|NCT03458910|144189412|SUPERIORITY|||||||0.19|||||||ANOVA|||time x condition x regulation goal (2 x 2 x 3) interaction effect in the right amygdala activity for younger adults||||0.190
72422989|NCT01597505|144356595|SUPERIORITY|Surotomycin was superior to vancomycin if the p-value was less than 0.05||||||0.011||||||Log-rank test of equality of survival times, stratified by age group (\< 75, \>= 75 years) and number of CDAD episodes (0, \>= 1). Significance cut-off = 0.05|Log Rank|||Stratified Log-Rank p-Value||||0.011
72422990|NCT01597505|144356596|SUPERIORITY|Surotomycin - Vancomycin. For surotomycin to be considered superior to vancomycin the lower bound of the 2-sided 95% CI had to be \> 0%.|Difference in percentage of participants|2.2|||||TWO_SIDED|95.0|-10.7|14.8|||||Treatment group percentages were stratified by age group (\< 75, ≥ 75) and number of previous CDAD episodes (0, ≥ 1). The 95% CIs were stratified Wilson intervals for the treatment group percentages.|Difference in percentage of participants||14.8|-10.7|
72422991|NCT01597505|144356597|SUPERIORITY|Surotomycin - Vancomycin. For surotomycin to be considered superior to vancomycin the lower bound of the 2-sided 95% CI had to be \> 0%.|Difference in percentage of participants|-2.4|||||TWO_SIDED|95.0|-7.8|3.0|||||Treatment group proportions were stratified by age group (\< 75, ≥ 75) and number of previous CDAD episodes (0, ≥1). The 95% CIs were stratified Wilson intervals for the treatment group proportions.|Difference in percentage of participants||3.0|-7.8|
72422992|NCT01597505|144356598|SUPERIORITY|Surotomycin - Vancomycin. For surotomycin to be considered superior to vancomycin the lower bound of the 2-sided 95% CI had to be \> 0%.|Difference in percentage of participants|14.6|||||TWO_SIDED|95.0|-2.7|30.7|||||Treatment group percentages were stratified by age group (\< 75, ≥ 75) and number of previous CDAD episodes (0, ≥ 1). The 95% CIs were stratified Wilson intervals for the treatment group percentages.|Difference in percentage of participants||30.7|-2.7|
72422993|NCT01597505|144356599|SUPERIORITY|Surotomycin - Vancomycin. For surotomycin to be considered superior to vancomycin the lower bound of the 2-sided 95% CI had to be \> 0%.|Difference in percentage of participants|4.3|||||TWO_SIDED|95.0|-4.2|12.7|||||Treatment group proportions were stratified by age group (\< 75, ≥ 75) and number of previous CDAD episodes (0, ≥1). The 95% CIs were stratified Wilson intervals for the treatment group proportions.|Difference in percentage of participants||12.7|-4.2|
72422994|NCT05454410|144356600|SUPERIORITY||Mean Difference (Net)|-5.2|||||TWO_SIDED|90.0|-9.6|-0.7|||ANCOVA||Placebo adjusted means (MIJ821-Placebo). 90% CIs are nominal and not adjusted for multiplicity.|||-0.7|-9.6|
72422995|NCT05454410|144356600|SUPERIORITY||Mean Difference (Net)|-2.5|||||TWO_SIDED|90.0|-7.0|2.1|||ANCOVA||Placebo adjusted means (MIJ821-Placebo). 90% CIs are nominal and not adjusted for multiplicity.|||2.1|-7.0|
72332519|NCT03458910|144189413|SUPERIORITY|||||||0.864|||||||ANOVA|||time x condition x regulation goal (2 x 2 x 3) interaction effect in the right amygdala activity for older adults||||0.864
72332520|NCT03458910|144189414|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Comparing acceptance rate of fair offers||||1.000
72332521|NCT03458910|144189414|SUPERIORITY|||||||0.716|||||||Wilcoxon (Mann-Whitney)|||Comparing acceptance rate of unfair offers||||0.716
72332522|NCT03458910|144189415|SUPERIORITY|||||||0.014|||||||t-test, 2 sided|||An independent t-test was performed to compare the two groups for dorsal anterior cingulate cortex activation.||||0.014
72422996|NCT05454410|144356600|SUPERIORITY||Mean Difference (Net)|0.6|||||TWO_SIDED|90.0|-4.0|5.1|||ANCOVA||Placebo adjusted means (MIJ821-Placebo). 90% CIs are nominal and not adjusted for multiplicity.|||5.1|-4.0|
72422997|NCT05454410|144356606|SUPERIORITY|||||||0.0242||||||P-value for the selected model best representing the underlying DR (the lowest p-value out of the 6 candidate models), adjusted for multiple comparisons.|Multiple contrast test|||MCP-Mod was used to check if there was a DR relationship between the change from baseline to 24 hours in MADRS total score and the doses received. The Least squares means under the primary estimand were used to test the null hypothesis of a flat DR relationship at a one-sided significance level of 5% against the alternative hypothesis of a non-flat DR curve. Six candidate DR curves were used to derive the optimal model contrasts for the multiple contrast tests. A monotone DR was assumed.||||0.0242
72422998|NCT05807919|144356669|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.00
72422999|NCT05807919|144356670|SUPERIORITY|||||||0.39|||||||Fisher Exact|||||||0.39
72423000|NCT05807919|144356671|SUPERIORITY|||||||0.18|||||||Fisher Exact|||||||0.18
72423001|NCT05807919|144356672|SUPERIORITY|||||||0.02|||||||Wilcoxon (Mann-Whitney)|||||||0.02
72423002|NCT05807919|144356673|SUPERIORITY|||||||0.39|||||||Fisher Exact|||||||0.39
72423003|NCT05807919|144356674|SUPERIORITY|||||||0.48|||||||Fisher Exact|||||||0.48
72423004|NCT01622010|144356684|EQUIVALENCE|P value 0.05 used||||||0.487|||||||Chi-squared|||||||0.487
72423005|NCT01622010|144356686|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|a non-inferiority margin calculation was not performed for this study prior to its start.||||||0.628|||||||Fisher Exact|||Null hypothesis: Standard care is better than standard care with video enhancement.||||0.628
72423006|NCT01622010|144356687|EQUIVALENCE|P Value 0.05 used||||||0.647|||||||Chi-squared|||||||0.647
72423007|NCT00947661|144356695|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of covariance included treatment, site, and intraocular pressure group as a covariate. Two-sided 95% confidence interval for the difference between treatment groups in estimated mean change from baseline lease square means was computed for each time point. Non-inferiority of SPARC drug relative to Reference was established if: 95% confidence interval included 0, the upper limit of the 95% CI was \<1.5, and upper limit of 95% CI was \<1 at most (at least 7 of 12) time point.|||||<|0.01|TWO_SIDED||||||ANCOVA|||||||<0.01
72332523|NCT03458910|144189415|SUPERIORITY|||||||0.059|||||||t-test, 2 sided|||An independent t-test was performed to compare the two groups for anterior insula activation.||||0.059
72332524|NCT03458910|144189416|SUPERIORITY|||||||0.144|||||||ANOVA|p-value reflects effect of interest, a time x condition interaction on scores||||||.144
72332525|NCT03458910|144189416|SUPERIORITY|||||||0.653||||||Linear mixed effects model with random factors (intercepts) for participants; F- and p-values determined using Satterthwaite's method|Mixed Models Analysis|||||||0.653
72423008|NCT02552238|144356696|SUPERIORITY|||||||0.0067|||||||McNemar|||Sensitivity: superiority test comparing CE-DSE and UE-DSE based on the difference||||0.0067
72423009|NCT02552238|144356696|SUPERIORITY||||||<|0.0001|||||||McNemar|||Specificity: superiority test comparing CE-DSE and UE-DSE based on the difference||||<0.0001
72423010|NCT02036645|144356714|SUPERIORITY_OR_OTHER||Slope|0.93|||||TWO_SIDED|95.0|0.82|1.04|||Regression, Linear||Since an Estimation approach was taken for the statistical analysis, no p-values were calculated|||1.04|0.82|
72423011|NCT02036645|144356714|SUPERIORITY_OR_OTHER||Slope|1.01|||||TWO_SIDED|95.0|0.71|1.3|||Regression, Linear||Since an Estimation approach was taken for the statistical analysis, no p-values were calculated|||1.30|0.71|
72423012|NCT02036645|144356715|SUPERIORITY_OR_OTHER||Slope|0.9|||||TWO_SIDED|95.0|0.81|0.98|||Regression, Linear||Since an Estimation approach was taken for the statistical analysis, no p-values were calculated|||0.98|0.81|
72423013|NCT02036645|144356715|SUPERIORITY_OR_OTHER||Slope|0.96|||||TWO_SIDED|95.0|0.65|1.27|||Regression, Linear||Since an Estimation approach was taken for the statistical analysis, no p-values were calculated|||1.27|0.65|
72423014|NCT01986101|144356721|SUPERIORITY||Mean Difference (Final Values)|-2.9|STANDARD_ERROR_OF_MEAN|1.0||0.007|TWO_SIDED|95.0|-4.9|-1.0||Hochberg-adjusted|Mixed Models Analysis||A negative difference in least square mean change from baseline between SM-13496 group and placebo indicates a greater improvement in the SM-13496 group over the placebo group.|||-1.0|-4.9|0.007
72423015|NCT01986101|144356721|SUPERIORITY||Mean Difference (Final Values)|-2.0|STANDARD_ERROR_OF_MEAN|1.03||0.057|TWO_SIDED|95.0|-4.0|0.1||Hochberg-adjusted.|Mixed Models Analysis||A negative difference in least square mean change from baseline between SM-13496 group and placebo indicates a greater improvement in the SM-13496 group over the placebo group.|||0.1|-4.0|0.057
72423016|NCT01986101|144356722|SUPERIORITY||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.127||0.002|TWO_SIDED|95.0|-0.65|-0.15|||Mixed Models Analysis||A negative difference in least square mean change from baseline between SM-13496 group and placebo indicates a greater improvement in the SM-13496 group over the placebo group.|||-0.15|-0.65|0.002
72423017|NCT01986101|144356722|SUPERIORITY||Mean Difference (Final Values)|-0.31|STANDARD_ERROR_OF_MEAN|0.13||0.019|TWO_SIDED|95.0|-0.56|-0.05|||Mixed Models Analysis||A negative difference in least square mean change from baseline between SM-13496 group and placebo indicates a greater improvement in SM-13496 group over the placebo group.|||-0.05|-0.56|0.019
72423018|NCT01986101|144356723|SUPERIORITY||Mean Difference (Final Values)|-1.8|STANDARD_ERROR_OF_MEAN|0.89||0.037|TWO_SIDED|95.0|-3.6|-0.1|||ANCOVA||A negative difference in least square mean change from baseline between SM-13496 group and placebo indicates a greater improvement in the SM-13496 group over the placebo group.|||-0.1|-3.6|0.037
72423019|NCT01986101|144356723|SUPERIORITY||Mean Difference (Final Values)|-1.1|STANDARD_ERROR_OF_MEAN|0.92||0.223|TWO_SIDED|95.0|-2.9|0.7|||ANCOVA||A negative difference in least square mean change from baseline between SM-13496 group and placebo indicates a greater improvement in the SM-13496 group over the placebo group.|||0.7|-2.9|0.223
72423020|NCT01986101|144356724|SUPERIORITY||Mean Difference (Final Values)|-0.47|STANDARD_ERROR_OF_MEAN|0.262||0.076|TWO_SIDED|95.0|-0.98|0.05|||Mixed Models Analysis||A negative difference in least square mean change from baseline between SM-13496 group and placebo indicates a greater improvement in the SM-13496 group over the placebo group.|||0.05|-0.98|0.076
72423021|NCT01986101|144356724|SUPERIORITY||Mean Difference (Final Values)|-0.48|STANDARD_ERROR_OF_MEAN|0.269||0.075|TWO_SIDED|95.0|-1.01|0.05|||Mixed Models Analysis||A negative difference in least square mean change from baseline between SM-13496 group and placebo indicates a greater improvement in the SM-13496 group over the placebo group.|||0.05|-1.01|0.075
72423022|NCT01986101|144356725|SUPERIORITY||Mean Difference (Final Values)|-1.7|STANDARD_ERROR_OF_MEAN|0.7||0.016|TWO_SIDED|95.0|-3.1|-0.3|||ANCOVA||A negative difference in least square mean change from baseline between SM-13496 group and placebo indicates a greater improvement in the SM-13496 group over the placebo group.|||-0.3|-3.1|0.016
72423023|NCT01986101|144356725|SUPERIORITY||Mean Difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|0.71||0.294|TWO_SIDED|95.0|-2.1|0.7|||ANCOVA||A negative difference in least square mean change from baseline between SM-13496 group and placebo indicates a greater improvement in the SM-13496 group over the placebo group.|||0.7|-2.1|0.294
72423024|NCT02404389|144356727|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|p value is provided|Mean Difference (Net)|0.0|STANDARD_DEVIATION|0.07||0.515|TWO_SIDED|90.0|-0.12|0.12|||Posterior mean|||||0.12|-0.12|0.515
72423025|NCT02404389|144356727|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|p value is provided|Mean Difference (Net)|0.0|STANDARD_DEVIATION|0.07||0.517|TWO_SIDED|90.0|-0.12|0.13|||posterior mean|||||0.13|-0.12|0.517
72423026|NCT03324880|144356753|SUPERIORITY||Difference in Least Squares (LS) Mean|-0.53|STANDARD_ERROR_OF_MEAN|0.189|=|0.003|TWO_SIDED|95.0|-0.9|-0.15||1-sided p-value was reported.|MMRM||||MMRM analysis over all post-baseline visits, with the change from baseline in HypoPT-SD symptom subscale score as the outcome, treatment group, visit, and their interaction as fixed effect factors and participants as a random effect, with adjustment for baseline HypoPT-SD symptom subscale score.|-0.15|-0.90|=0.003
72332526|NCT03458910|144189417|SUPERIORITY|||||||0.288|||||||ANOVA|p-value reflects effect of interest, a time x condition interaction on scores||||||.288
72332527|NCT03458910|144189417|SUPERIORITY|||||||0.191||||||Linear mixed effects model with random factors (intercepts) for participants; F- and p-values determined using Satterthwaite's method|Mixed Models Analysis|p-value reflects effect of interest, a time x condition interaction on scores||||||0.191
72332528|NCT03458910|144189418|SUPERIORITY|||||||0.894|||||||ANOVA|||||||0.894
72332529|NCT03458910|144189418|SUPERIORITY|||||||0.425||||||Linear mixed effects model with random factors (intercepts) for participants; F- and p-values determined using Satterthwaite's method|Mixed Models Analysis|p-value reflects effect of interest, a time x condition interaction on scores||||||0.425
72332530|NCT03458910|144189419|SUPERIORITY|||||||0.916|||||||ANOVA|p-value reflects effect of interest, a time x condition interaction on scores||||||0.916
72423027|NCT03324880|144356754|SUPERIORITY||Difference in LS Mean|10.5|STANDARD_ERROR_OF_MEAN|2.7|<|0.001|TWO_SIDED|95.0|5.1|15.9||1-sided p-value was reported.|MMRM||||MMRM analysis over all post-baseline visits, with the change from baseline in FACIT-Fatigue total score as the outcome, treatment group, visit, and their interaction as fixed effect factors and participants as a random effect with adjustment for baseline FACIT-Fatigue total score.|15.9|5.1|<0.001
72423028|NCT03324880|144356755|SUPERIORITY||Difference in LS Mean|4.242|STANDARD_ERROR_OF_MEAN|1.9219|=|0.015|TWO_SIDED|95.0|0.413|8.072||1-sided p-value was reported.|MMRM||||MMRM analysis over all post-baseline visits, with the change from baseline in SF-36 PCS score as the outcome, treatment group, visit, and their interaction as fixed effect factors and participants as a random effect with adjustment for baseline SF-36 PCS score.|8.072|0.413|=0.015
72423029|NCT03324880|144356756|SUPERIORITY||Difference in LS Mean|-0.32|STANDARD_ERROR_OF_MEAN|0.112|=|0.002|TWO_SIDED|95.0|-0.55|-0.1||1-sided p-value was reported.|MMRM||||MMRM analysis over all post-baseline visits, with the change from baseline in HypoPT-SD impact subscale score as the outcome, treatment group, visit, and their interaction as fixed effect factors and participants as a random effect, with adjustment for baseline HypoPT-SD impact subscale score.|-0.10|-0.55|=0.002
72332531|NCT03458910|144189419|SUPERIORITY|||||||0.235||||||Linear mixed effects model with random factors (intercepts) for participants; F- and p-values determined using Satterthwaite's method|Mixed Models Analysis|p-value reflects effect of interest, a time x condition interaction on scores||||||0.235
72332532|NCT03458910|144189420|SUPERIORITY|||||||0.462|||||||ANOVA|p-value reflects effect of interest, a time x condition interaction on scores||||||0.462
72332533|NCT03458910|144189420|SUPERIORITY|||||||0.468||||||Linear mixed effects model with random factors (intercepts) for participants; F- and p-values determined using Satterthwaite's method|Mixed Models Analysis|p-value reflects effect of interest, a time x condition interaction on scores||||||0.468
72423030|NCT03324880|144356757|SUPERIORITY||Difference in LS Mean|-0.28|STANDARD_ERROR_OF_MEAN|0.125|=|0.013|TWO_SIDED|95.0|-0.53|-0.04||1-sided p-value was reported.|MMRM|||Impact on Sleep|MMRM analysis over all post-baseline visits, with the change from baseline in HypoPT-SD impact item score as the outcome, treatment group, visit, and their interaction as fixed effect factors and participants as a random effect, with adjustment for baseline HypoPT-SD impact item score.|-0.04|-0.53|=0.013
72332534|NCT03458910|144189421|SUPERIORITY|||||||0.481|||||||ANOVA|p-value reflects effect of interest, a time x condition interaction on scores||||||0.481
72332535|NCT03458910|144189421|SUPERIORITY|||||||0.159||||||Linear mixed effects model with random factors (intercepts) for participants; F- and p-values determined using Satterthwaite's method|Mixed Models Analysis|p-value reflects effect of interest, a time x condition interaction on scores||||||0.159
72332536|NCT03458910|144189422|SUPERIORITY|||||||0.602|||||||ANOVA|p-value reflects effect of interest, a time x condition interaction on scores||||||0.602
72332537|NCT03458910|144189422|SUPERIORITY|||||||0.562||||||Linear mixed effects model with random factors (intercepts) for participants; F- and p-values determined using Satterthwaite's method|Mixed Models Analysis|p-value reflects effect of interest, a time x condition interaction on scores||||||0.562
72332538|NCT03458910|144189423|SUPERIORITY|||||||0.697|||||||ANOVA|p-value reflects effect of interest, a time x condition interaction on scores||||||0.697
72332539|NCT03458910|144189423|SUPERIORITY|||||||0.901||||||Linear mixed effects model with random factors (intercepts) for participants; F- and p-values determined using Satterthwaite's method|Mixed Models Analysis|p-value reflects effect of interest, a time x condition interaction on scores||||||0.901
72332540|NCT03458910|144189424|SUPERIORITY|||||||0.516|||||||ANOVA|p-value reflects effect of interest, a time x condition interaction||||||0.516
72332541|NCT03458910|144189425|SUPERIORITY|||||||0.944|||||||ANOVA|p-value reflects effect of interest, a time x condition interaction||||||0.944
72423031|NCT03324880|144356757|SUPERIORITY||Difference in LS Mean|-0.36|STANDARD_ERROR_OF_MEAN|0.128|=|0.003|TWO_SIDED|95.0|-0.61|-0.11||1-sided p-value was reported.|MMRM|||Ability to Exercise|MMRM analysis over all post-baseline visits, with the change from baseline in HypoPT-SD impact item score as the outcome, treatment group, visit, and their interaction as fixed effect factors and participants as a random effect, with adjustment for baseline HypoPT-SD impact item score.|-0.11|-0.61|=0.003
72332542|NCT03458910|144189426|SUPERIORITY|||||||0.285|||||||ANOVA|p-value reflects effect of interest, a time x condition interaction||||||0.285
72332543|NCT03458910|144189427|SUPERIORITY|||||||0.807|||||||ANOVA|p-value reflects effect of interest, a time x condition interaction||||||0.807
72332544|NCT03458910|144189428|SUPERIORITY||||||<|0.001|||||||ANOVA|p-value reflects effect of interest, a time x condition interaction||||||<0.001
72332545|NCT03458910|144189429|SUPERIORITY|||||||0.74|||||||ANOVA|p-value reflects effect of interest, a time x condition interaction||||||0.740
72332546|NCT03458910|144189430|SUPERIORITY|||||||0.083|||||||ANOVA|p-value reflects effect of interest, a time x condition interaction on scores||||||0.083
72332547|NCT03458910|144189431|SUPERIORITY|||||||0.176|||||||ANOVA|p-value reflects effect of interest, a time x condition interaction on scores||||||0.176
72332548|NCT03458910|144189432|SUPERIORITY|||||||0.325|||||||ANOVA|p-value reflects effect of interest, a time x condition interaction on scores||||||0.325
72332549|NCT03458910|144189433|SUPERIORITY|||||||0.751|||||||ANOVA|p-value reflects effect of interest, a time x condition interaction on scores||||||0.751
72332550|NCT03458910|144189434|SUPERIORITY|||||||0.011|||||||ANOVA|p-value reflects effect of interest, a time x condition interaction on scores||||||0.011
72332551|NCT03458910|144189435|SUPERIORITY|||||||0.885|||||||ANOVA|p-value reflects effect of interest, a time x condition interaction on scores||||||0.885
72332552|NCT03458910|144189436|SUPERIORITY|||||||0.259||||||p-value reflects time x condition interaction|ANOVA|||2 (time) x 2 (condition) ANOVA to test effects of time, condition, and time x condition interaction||||0.259
72332553|NCT03458910|144189437|SUPERIORITY|||||||0.000146||||||p-value reflects time x condition interaction|ANOVA|||2 (time) x 2 (condition) ANOVA to test effects of time, condition, and time x condition interaction||||0.000146
72332554|NCT03458910|144189438|SUPERIORITY|||||||0.463||||||time point x group (2 way) interaction|ANOVA|||||||0.463
72332555|NCT03458910|144189439|SUPERIORITY|||||||0.99||||||time point x group (2 way) interaction|ANOVA|||||||0.990
72332556|NCT03458910|144189440|SUPERIORITY|||||||0.034||||||time point x group (2 way) interaction|ANOVA|||||||0.034
72332557|NCT03458910|144189441|SUPERIORITY|||||||0.398||||||time point x group (2 way) interaction|ANOVA|||||||0.398
72332558|NCT03458910|144189442|SUPERIORITY|||||||0.113||||||time point x group (2 way) interaction|ANOVA|||||||0.113
72332559|NCT03458910|144189443|SUPERIORITY|||||||0.637||||||time point x group (2 way) interaction|ANOVA|||||||0.637
72332560|NCT03458910|144189444|SUPERIORITY|time x condition interaction in CRP for younger adults||||||0.133|||||||ANOVA|||||||0.133
72332561|NCT03458910|144189445|SUPERIORITY|time x condition interaction in CRP for older adults||||||0.402|||||||ANOVA|||||||0.402
72423032|NCT03324880|144356757|SUPERIORITY||Difference in LS Mean|-0.36|STANDARD_ERROR_OF_MEAN|0.123|=|0.002|TWO_SIDED|95.0|-0.61|-0.12||1-sided p-value was reported.|MMRM|||Ability to Complete Work|MMRM analysis over all post-baseline visits, with the change from baseline in HypoPT-SD impact item score as the outcome, treatment group, visit, and their interaction as fixed effect factors and participants as a random effect, with adjustment for baseline HypoPT-SD impact item score.|-0.12|-0.61|=0.002
72423033|NCT03324880|144356757|SUPERIORITY||Difference in LS Mean|-0.37|STANDARD_ERROR_OF_MEAN|0.121|=|0.002|TWO_SIDED|95.0|-0.61|-0.13||1-sided p-value was reported.|MMRM|||Impact Family Relationships|MMRM analysis over all post-baseline visits, with the change from baseline in HypoPT-SD impact item score as the outcome, treatment group, visit, and their interaction as fixed effect factors and participants as a random effect, with adjustment for baseline HypoPT-SD impact item score.|-0.13|-0.61|=0.002
72423034|NCT03324880|144356758|SUPERIORITY||Difference in LS Mean|-0.55|STANDARD_ERROR_OF_MEAN|0.203|=|0.004|TWO_SIDED|95.0|-0.96|-0.15||1-sided p-value was reported.|MMRM||||MMRM analysis over all post-baseline visits, with the change from baseline in HypoPT-SD anxiety item score as the outcome, treatment group, visit, and their interaction as fixed effect factors and participants as a random effect, with adjustment for baseline HypoPT-SD anxiety item score.|-0.15|-0.96|=0.004
72423035|NCT03324880|144356759|SUPERIORITY||Difference in LS Mean|-0.54|STANDARD_ERROR_OF_MEAN|0.2|=|0.004|TWO_SIDED|95.0|-0.93|-0.14||1-sided p-value was reported.|MMRM||||MMRM analysis over all post-baseline visits, with the change from baseline in HypoPT-SD sadness or depression item score as the outcome, treatment group, visit, and their interaction as fixed effect factors and participants as a random effect, with adjustment for baseline HypoPT-SD sadness or depression item score.|-0.14|-0.93|=0.004
72332562|NCT03458910|144189446|SUPERIORITY|time x condition interaction in cytokine IL-1b for younger adults||||||0.236||||||p value for time x condition interaction effect|ANOVA|||||||0.236
72332563|NCT03458910|144189447|SUPERIORITY|time x condition interaction in cytokine IL-1b for older adults||||||0.6||||||p value for time x condition interaction effect|ANOVA|||||||0.600
72332564|NCT03458910|144189448|SUPERIORITY|time x condition interaction in cytokine IL-6 for younger adults||||||0.788||||||p value for time x condition interaction effect|ANOVA|||||||0.788
72332565|NCT03458910|144189449|SUPERIORITY|time x condition interaction in cytokine IL-6 for older adults||||||0.917||||||p value for time x condition interaction effect|ANOVA|||||||0.917
72332566|NCT03458910|144189450|SUPERIORITY|time x condition interaction in cytokine IL-8 for younger adults||||||0.844||||||p value for time x condition interaction effect|ANOVA|||||||0.844
72332567|NCT03458910|144189451|SUPERIORITY|time x condition interaction in cytokine IL-8 for older adults||||||0.75||||||p value for time x condition interaction effect|ANOVA|||||||0.750
72332568|NCT03458910|144189452|SUPERIORITY|time x condition interaction in cytokine TNF-a for younger adults||||||0.074||||||p value for time x condition interaction effect|ANOVA|||||||0.074
72332569|NCT03458910|144189453|SUPERIORITY|time x condition interaction in cytokine TNF-a for older adults||||||0.0505||||||p value for time x condition interaction effect|ANOVA|||||||0.0505
72332570|NCT03458910|144189468|SUPERIORITY|||||||0.022|||||||t-test, 2 sided|||An independent t-test was performed to compare the two groups.||||0.022
72332571|NCT03458910|144189469|SUPERIORITY|||||||0.455|||||||t-test, 2 sided|||An independent t-test was performed to compare the two groups.||||0.455
72332572|NCT03458910|144189470|SUPERIORITY|||||||0.022|||||||ANOVA|||A 2 (time: pre, post) X 2 (condition: HRV-increase, HRV-decrease) ANOVA was performed.||||0.022
72332573|NCT03458910|144189471|SUPERIORITY|||||||0.455|||||||ANOVA|||A 2 (time: pre, post) X 2 (condition: HRV-increase, HRV-decrease) ANOVA was performed.||||0.455
72332574|NCT03458910|144189472|SUPERIORITY|||||||0.462||||||time point x group (2 way) interaction|ANOVA|||||||0.462
72332575|NCT03458910|144189473|SUPERIORITY|||||||0.305||||||time point x group (2 way) interaction|ANOVA|||||||0.305
72332576|NCT03458910|144189474|SUPERIORITY|||||||0.804||||||time point x group (2 way) interaction|ANOVA|||||||0.804
72332577|NCT03458910|144189475|SUPERIORITY|||||||0.141||||||time point x group (2 way) interaction|ANOVA|||||||0.141
72332578|NCT03458910|144189476|SUPERIORITY|||||||0.292||||||time point x group(2 way) interaction|ANOVA|||||||0.292
72332579|NCT03458910|144189477|SUPERIORITY|||||||0.905||||||time point x group (2 way) interaction|ANOVA|||||||0.905
72332580|NCT03458910|144189478|SUPERIORITY|||||||0.641||||||p value for time x condition x error type interaction effect|ANOVA|||time x condition x error type interaction in Sustained Attention to Response Task (SART) for younger adults||||0.641
72332581|NCT03458910|144189479|SUPERIORITY|||||||0.813||||||p value for time x condition x error type interaction effect|ANOVA|||time x condition x error type interaction in Sustained Attention to Response Task (SART) for older adults||||0.813
72332582|NCT03458910|144189480|SUPERIORITY|||||||0.695|||||||ANOVA|||Hits during recognition task for younger adults||||.695
72332583|NCT03458910|144189481|SUPERIORITY|||||||0.27|||||||ANOVA|||Hits during recognition task for older adults||||.270
72332584|NCT03458910|144189482|SUPERIORITY|||||||0.102|||||||ANOVA|||False alarms during recognition task for younger adults||||.102
72332585|NCT03458910|144189483|SUPERIORITY|||||||0.257|||||||ANOVA|||False alarms during recognition task for older adults||||.257
72332586|NCT03458910|144189484|SUPERIORITY|||||||0.067|||||||ANOVA|||Group difference for recall for younger adults||||.067
72332587|NCT03458910|144189485|SUPERIORITY|||||||0.117|||||||ANOVA|||Group difference for recall for older adults||||.117
72332588|NCT03458910|144189486|SUPERIORITY|||||||0.558||||||p value for time x condition interaction effect|ANOVA|||time x condition x collection interaction in cortisol levels for younger adults||||0.558
72332589|NCT02731820|144189514|OTHER|||||||0.172|||||||t-test, 1 sided|||Paired analysis within the group to evaluate the effect of Potassium Citrate: T3 vs T0||||0.172
72332590|NCT02731820|144189514|OTHER|||||||0.027|||||||t-test, 1 sided|||Paired analysis within the group to evaluate the effect of Potassium Citrate: T6 vs T0||||0.027
72332591|NCT02731820|144189514|OTHER|||||||0.053|||||||t-test, 1 sided|||Paired analysis within the group to evaluate the effect of Potassium Citrate: T6 vs T3||||0.053
72332592|NCT02731820|144189514|OTHER|||||||0.002|||||||t-test, 1 sided|||Paired analysis within the group to evaluate the effect of Placebo: T3 vs T0||||0.002
72332593|NCT02731820|144189514|OTHER|||||||0.006|||||||t-test, 1 sided|||Paired analysis within the group to evaluate the effect of Placebo: T6 vs T0||||0.006
72332594|NCT02731820|144189514|OTHER|||||||0.139|||||||t-test, 1 sided|||Paired analysis within the group to evaluate the effect of Placebo: T6 vs T3||||0.139
72332595|NCT02731820|144189514|OTHER|||||||0.967|||||||t-test, 2 sided|||Independent comparison (unpaired analysis) between Potassium Citrate and Placebo at T0||||0.967
72332596|NCT02731820|144189514|OTHER|||||||0.446|||||||t-test, 2 sided|||Independent comparison (unpaired analysis) between Potassium Citrate and Placebo at T3||||0.446
72332597|NCT02731820|144189514|OTHER|||||||0.869|||||||t-test, 2 sided|||Independent comparison (unpaired analysis) between Potassium Citrate and Placebo at T6||||0.869
72332598|NCT02731820|144189515|OTHER|||||||0.954|||||||t-test, 1 sided|||Paired analysis within the group to evaluate the effect of Potassium Citrate: T3 vs T0||||0.954
72332599|NCT02731820|144189515|OTHER|||||||0.798|||||||t-test, 1 sided|||Paired analysis within the group to evaluate the effect of Potassium Citrate: T6 vs T0||||0.798
72423036|NCT03324880|144356760|SUPERIORITY||Difference in LS Mean|-0.56|STANDARD_ERROR_OF_MEAN|0.218|=|0.006|TWO_SIDED|95.0|-0.99|-0.12||1-sided p-value was reported.|MMRM|||Muscle Cramps|MMRM analysis over all post-baseline visits, with the change from baseline in HypoPT-SD symptom item score as the outcome, treatment group, visit, and their interaction as fixed effect factors and participants as a random effect, with adjustment for baseline HypoPT-SD symptom item score.|-0.12|-0.99|=0.006
72332600|NCT02731820|144189515|OTHER|||||||0.377|||||||t-test, 1 sided|||Paired analysis within the group to evaluate the effect of Potassium Citrate: T6 vs T3||||0.377
72332601|NCT02731820|144189515|OTHER|||||||0.886|||||||t-test, 1 sided|||Paired analysis within the group to evaluate the effect of Placebo: T3 vs T0||||0.886
72332602|NCT02731820|144189515|OTHER|||||||0.04|||||||t-test, 1 sided|||Paired analysis within the group to evaluate the effect of Placebo: T6 vs T0||||0.040
72332603|NCT02731820|144189515|OTHER|||||||0.017|||||||t-test, 1 sided|||Paired analysis within the group to evaluate the effect of Placebo: T6 vs T3||||0.017
72332604|NCT02731820|144189515|OTHER|||||||0.343|||||||t-test, 2 sided|||Independent comparison (unpaired analysis) between Potassium Citrate and Placebo at T0||||0.343
72423037|NCT03324880|144356760|SUPERIORITY||Difference in LS Mean|-0.54|STANDARD_ERROR_OF_MEAN|0.213|=|0.007|TWO_SIDED|95.0|-0.96|-0.12||1-sided p-value was reported.|MMRM|||Tingling|MMRM analysis over all post-baseline visits, with the change from baseline in HypoPT-SD symptom item score as the outcome, treatment group, visit, and their interaction as fixed effect factors and participants as a random effect, with adjustment for baseline HypoPT-SD symptom item score.|-0.12|-0.96|=0.007
72423038|NCT03324880|144356760|SUPERIORITY||Difference in LS Mean|-0.48|STANDARD_ERROR_OF_MEAN|0.231|=|0.02|TWO_SIDED|95.0|-0.94|-0.02||1-sided p-value was reported.|MMRM||||MMRM analysis over all post-baseline visits, with the change from baseline in HypoPT-SD symptom item score as the outcome, treatment group, visit, and their interaction as fixed effect factors and participants as a random effect, with adjustment for baseline HypoPT-SD symptom item score.|-0.02|-0.94|=0.020
72423039|NCT03324880|144356760|SUPERIORITY||Difference in LS Mean|-0.62|STANDARD_ERROR_OF_MEAN|0.219|=|0.003|TWO_SIDED|95.0|-1.05|-0.18||1-sided p-value was reported.|MMRM|||Muscle Spasms|MMRM analysis over all post-baseline visits, with the change from baseline in HypoPT-SD symptom item score as the outcome, treatment group, visit, and their interaction as fixed effect factors and participants as a random effect, with adjustment for baseline HypoPT-SD symptom item score.|-0.18|-1.05|=0.003
72423040|NCT03324880|144356760|SUPERIORITY||Difference in LS Mean|-0.38|STANDARD_ERROR_OF_MEAN|0.229|=|0.05|TWO_SIDED|95.0|-0.83|0.07||1-sided p-value was reported.|MMRM|||Feelings of Heaviness|MMRM analysis over all post-baseline visits, with the change from baseline in HypoPT-SD symptom item score as the outcome, treatment group, visit, and their interaction as fixed effect factors and participants as a random effect, with adjustment for baseline HypoPT-SD symptom item score.|0.07|-0.83|=0.050
72423041|NCT03324880|144356760|SUPERIORITY||Difference in LS Mean|-0.55|STANDARD_ERROR_OF_MEAN|0.227|=|0.008|TWO_SIDED|95.0|-1.01|-0.1||1-sided p-value was reported.|MMRM|||Physical Fatigue|MMRM analysis over all post-baseline visits, with the change from baseline in HypoPT-SD symptom item score as the outcome, treatment group, visit, and their interaction as fixed effect factors and participants as a random effect, with adjustment for baseline HypoPT-SD symptom item score.|-0.10|-1.01|=0.008
72423042|NCT03324880|144356760|SUPERIORITY||Difference in LS Mean|-0.51|STANDARD_ERROR_OF_MEAN|0.186|=|0.004|TWO_SIDED|95.0|-0.87|-0.14||1-sided p-value was reported.|MMRM|||Brain Fog|MMRM analysis over all post-baseline visits, with the change from baseline in HypoPT-SD symptom item score as the outcome, treatment group, visit, and their interaction as fixed effect factors and participants as a random effect, with adjustment for baseline HypoPT-SD symptom item score.|-0.14|-0.87|=0.004
72423043|NCT03324880|144356762|SUPERIORITY||Difference in LS Mean|-0.9|STANDARD_ERROR_OF_MEAN|0.235|<|0.001|TWO_SIDED|95.0|-1.37|-0.43||1-sided p-value was reported.|MMRM||||MMRM analysis over all post-baseline visits, with the change from baseline in HypoPT-SD most bothersome symptom score as the outcome, treatment group, visit, and their interaction as fixed effect factors and participants as a random effect, with adjustment for baseline HypoPT-SD most bothersome symptom score.|-0.43|-1.37|<0.001
72423044|NCT03324880|144356763|SUPERIORITY||Difference in LS Mean|2.1|STANDARD_ERROR_OF_MEAN|1.07|=|0.024|TWO_SIDED|95.0|0.0|4.3||1-sided p-value was reported.|MMRM||||MMRM analysis over all post-baseline visits, with the change from baseline in FACT-Cog Perceived Cognitive Impairments Subscale score as the outcome, treatment group, visit, and their interaction as fixed effect factors and participants as a random effect with adjustment for baseline FACT-Cog Perceived Cognitive Impairments Subscale score.|4.3|0.0|=0.024
72423045|NCT03324880|144356764|SUPERIORITY||Difference in LS Mean|2.1|STANDARD_ERROR_OF_MEAN|1.07|=|0.024|TWO_SIDED|95.0|0.0|4.3||1-sided p-value was reported.|MMRM||||MMRM analysis over all post-baseline visits, with the change from baseline in FACT-Cog QoL Subscale score as the outcome, treatment group, visit, and their interaction as fixed effect factors and participants as a random effect with adjustment for baseline FACT-Cog QoL Subscale score.|4.3|0.0|=0.024
72423046|NCT03324880|144356765|SUPERIORITY||Difference in LS Mean|7.21|STANDARD_ERROR_OF_MEAN|2.1376|=|0.001|TWO_SIDED|95.0|2.951|11.469||1-sided p-value was reported.|MMRM|||Standard-Bodily Pain|MMRM analysis over all post-baseline visits, with the change from baseline in SF-36 domain score as the outcome, treatment group, visit, and their interaction as fixed effect factors and participants as a random effect with adjustment for baseline SF-36 domain score.|11.469|2.951|=0.001
72423047|NCT03324880|144356765|SUPERIORITY||Difference in LS Mean|5.545|STANDARD_ERROR_OF_MEAN|2.0542|=|0.004|TWO_SIDED|95.0|1.452|9.638||1-sided p-value was reported.|MMRM|||Standard-General Health|MMRM analysis over all post-baseline visits, with the change from baseline in SF-36 domain score as the outcome, treatment group, visit, and their interaction as fixed effect factors and participants as a random effect with adjustment for baseline SF-36 domain score.|9.638|1.452|=0.004
72423048|NCT03324880|144356765|SUPERIORITY||Difference in LS Mean|7.857|STANDARD_ERROR_OF_MEAN|2.2913|<|0.001|TWO_SIDED|95.0|3.292|12.423||1-sided p-value was reported.|MMRM|||Standard-Mental Health|MMRM analysis over all post-baseline visits, with the change from baseline in SF-36 domain score as the outcome, treatment group, visit, and their interaction as fixed effect factors and participants as a random effect with adjustment for baseline SF-36 domain score.|12.423|3.292|<0.001
72423049|NCT03324880|144356765|SUPERIORITY||MMRM|4.554|STANDARD_ERROR_OF_MEAN|2.1123|=|0.017|TWO_SIDED|95.0|0.345|8.763||1-sided p-value was reported.|MMRM|||Standard-Physical Functioning|MMRM analysis over all post-baseline visits, with the change from baseline in SF-36 domain score as the outcome, treatment group, visit, and their interaction as fixed effect factors and participants as a random effect with adjustment for baseline SF-36 domain score.|8.763|0.345|=0.017
72332605|NCT02731820|144189515|OTHER|||||||0.859|||||||t-test, 2 sided|||Independent comparison (unpaired analysis) between Potassium Citrate and Placebo at T3||||0.859
72332606|NCT02731820|144189515|OTHER|||||||0.172|||||||t-test, 2 sided|||Independent comparison (unpaired analysis) between Potassium Citrate and Placebo at T6||||0.172
72332607|NCT02731820|144189516|OTHER|||||||0.213|||||||t-test, 1 sided|||Paired analysis within the group to evaluate the effect of Potassium Citrate: T3 vs T0||||0.213
72423050|NCT03324880|144356765|SUPERIORITY||Difference in LS Mean|8.42|STANDARD_ERROR_OF_MEAN|2.3186|<|0.001|TWO_SIDED|95.0|3.8|13.04||1-sided p-value was reported.|MMRM|||Standard-Role-Emotional|MMRM analysis over all post-baseline visits, with the change from baseline in SF-36 domain score as the outcome, treatment group, visit, and their interaction as fixed effect factors and participants as a random effect with adjustment for baseline SF-36 domain score.|13.040|3.800|<0.001
72423051|NCT03324880|144356765|SUPERIORITY||Difference in LS Mean|4.23|STANDARD_ERROR_OF_MEAN|2.2489|=|0.032|TWO_SIDED|95.0|-0.251|8.711||1-sided p-value was reported.|MMRM|||Standard-Role-Physical|MMRM analysis over all post-baseline visits, with the change from baseline in SF-36 domain score as the outcome, treatment group, visit, and their interaction as fixed effect factors and participants as a random effect with adjustment for baseline SF-36 domain score.|8.711|-0.251|=0.032
72423052|NCT03324880|144356765|SUPERIORITY||Difference in LS Mean|3.809|STANDARD_ERROR_OF_MEAN|2.6658|=|0.079|TWO_SIDED|95.0|-1.502|9.121||1-sided p-value was reported.|MMRM|||Standard-Social Functioning|MMRM analysis over all post-baseline visits, with the change from baseline in SF-36 domain score as the outcome, treatment group, visit, and their interaction as fixed effect factors and participants as a random effect with adjustment for baseline SF-36 domain score.|9.121|-1.502|=0.079
72423053|NCT03324880|144356765|SUPERIORITY||Difference in LS Mean|7.942|STANDARD_ERROR_OF_MEAN|2.353|=|0.001|TWO_SIDED|95.0|3.253|12.63||1-sided p-value was reported.|MMRM|||Standard-Vitality|MMRM analysis over all post-baseline visits, with the change from baseline in SF-36 domain score as the outcome, treatment group, visit, and their interaction as fixed effect factors and participants as a random effect with adjustment for baseline SF-36 domain score.|12.630|3.253|=0.001
72423054|NCT03324880|144356766|SUPERIORITY||Difference in LS Mean|8.3|STANDARD_ERROR_OF_MEAN|2.2642|<|0.001|TWO_SIDED|95.0|3.788|12.811||1-sided p-value|MMRM||||MMRM analysis over all post-baseline visits, with the change from baseline in SF-36 MCS score as the outcome, treatment group, visit, and their interaction as fixed effect factors and participants as a random effect with adjustment for baseline SF-36 MCS score.|12.811|3.788|<0.001
72423055|NCT03324880|144356767|SUPERIORITY||Difference in LS Mean|3.13|STANDARD_ERROR_OF_MEAN|9.578|=|0.627|TWO_SIDED|95.0|-16.33|22.6||1-sided p-value was reported.|MMRM|||Percent Work Time Missed Due to Problem|MMRM analysis over all post-baseline visits, with the change from baseline in WPAI score as the outcome, treatment group, visit, and their interaction as fixed effect factors and participants as a random effect with adjustment for baseline WPAI score.|22.60|-16.33|=0.627
72423056|NCT03324880|144356767|SUPERIORITY||Difference in LS Mean|-14.6|STANDARD_ERROR_OF_MEAN|7.52|=|0.031|TWO_SIDED|95.0|-29.9|0.7||1-sided p-value was reported.|MMRM|||Percent Impairment While Working Due to Problem|MMRM analysis over all post-baseline visits, with the change from baseline in WPAI score as the outcome, treatment group, visit, and their interaction as fixed effect factors and participants as a random effect with adjustment for baseline WPAI score.|0.7|-29.9|=0.031
72423057|NCT03324880|144356767|SUPERIORITY||Difference in LS Mean|-14.9|STANDARD_ERROR_OF_MEAN|6.146|=|0.011|TWO_SIDED|95.0|-27.42|-2.39||1-sided p-value was reported.|MMRM|||Percent Overall Work Impairment Due to Problem|MMRM analysis over all post-baseline visits, with the change from baseline in WPAI score as the outcome, treatment group, visit, and their interaction as fixed effect factors and participants as a random effect with adjustment for baseline WPAI score.|-2.39|-27.42|=0.011
72423058|NCT03324880|144356767|SUPERIORITY||Difference in LS Mean|-13.0|STANDARD_ERROR_OF_MEAN|5.78|=|0.014|TWO_SIDED|95.0|-24.5|-1.5||1-sided p-value was reported.|MMRM|||Percent Activity Impairment Due to Problem|MMRM analysis over all post-baseline visits, with the change from baseline in WPAI score as the outcome, treatment group, visit, and their interaction as fixed effect factors and participants as a random effect with adjustment for baseline WPAI score.|-1.5|-24.5|=0.014
72423059|NCT03324880|144356768|SUPERIORITY||Difference in LS Mean|-0.5|STANDARD_ERROR_OF_MEAN|0.22|=|0.01|TWO_SIDED|95.0|-1.0|-0.1||1-sided p-value|MMRM||||MMRM analysis over all post-baseline visits, with the change from baseline in PGI-S score as the outcome, treatment group, visit, and their interaction as fixed effect factors and participants as a random effect with adjustment for baseline PGI-S score.|-0.1|-1.0|=0.010
72423060|NCT03324880|144356770|SUPERIORITY||Difference in LS Mean|0.01|||=|0.516|TWO_SIDED|95.0|-0.03|0.05|||ANCOVA|From an Analysis of Covariance (ANCOVA) with treatment group (rhPTH(l-84), placebo) as the predictor and Baseline score as a covariate.||Detection||0.05|-0.03|=0.516
72423061|NCT03324880|144356770|SUPERIORITY||Difference in LS Mean|0.02|||=|0.275|TWO_SIDED|95.0|-0.02|0.06|||ANCOVA|From an ANCOVA with treatment group (rhPTH(l-84), placebo) as the predictor and Baseline score as a covariate.||Identification||0.06|-0.02|=0.275
72423062|NCT03324880|144356770|SUPERIORITY||Difference in LS Mean|0.01|||=|0.777|TWO_SIDED|95.0|-0.05|0.07|||ANCOVA|From an ANCOVA with treatment group (rhPTH(l-84), placebo) as the predictor and Baseline score as a covariate.||One Card Learning||0.07|-0.05|=0.777
72423063|NCT03324880|144356770|SUPERIORITY||Difference in LS Mean|0.01|||=|0.831|TWO_SIDED|95.0|-0.04|0.05|||ANCOVA|From an ANCOVA with treatment group (rhPTH(l-84), placebo) as the predictor and Baseline score as a covariate.||One Back (ONB)||0.05|-0.04|=0.831
72423064|NCT03324880|144356770|SUPERIORITY||Difference in LS Mean|9.93|||=|0.075|TWO_SIDED|95.0|-1.0|20.85|||ANCOVA|From an ANCOVA with treatment group (rhPTH(l-84), placebo) as the predictor and Baseline score as a covariate.||Groton Maze Learning (GML)||20.85|-1.00|=0.075
72423065|NCT03324880|144356770|SUPERIORITY||Difference in LS Mean|-0.57|||=|0.545|TWO_SIDED|95.0|-2.41|1.27|||ANCOVA|From an ANCOVA with treatment group (rhPTH(l-84), placebo) as the predictor and Baseline score as a covariate.||International Shopping List (ISL)||1.27|-2.41|=0.545
72332608|NCT02731820|144189516|OTHER|||||||0.191|||||||t-test, 1 sided|||Paired analysis within the group to evaluate the effect of Potassium Citrate: T6 vs T0||||0.191
72332609|NCT02731820|144189516|OTHER|||||||0.234|||||||t-test, 1 sided|||Paired analysis within the group to evaluate the effect of Potassium Citrate: T6 vs T3||||0.234
72332610|NCT02731820|144189516|OTHER|||||||0.37|||||||t-test, 1 sided|||Paired analysis within the group to evaluate the effect of Placebo: T3 vs T0||||0.370
72332611|NCT02731820|144189516|OTHER|||||||0.176|||||||t-test, 1 sided|||Paired analysis within the group to evaluate the effect of Placebo: T6 vs T0||||0.176
72332612|NCT02731820|144189516|OTHER|||||||0.139|||||||t-test, 1 sided|||Paired analysis within the group to evaluate the effect of Placebo: T6 vs T3||||0.139
72332613|NCT02731820|144189516|OTHER|||||||0.551|||||||t-test, 2 sided|||Independent comparison (unpaired analysis) between Potassium Citrate and Placebo at T0||||0.551
72332614|NCT02731820|144189516|OTHER|||||||0.371|||||||t-test, 2 sided|||Independent comparison (unpaired analysis) between Potassium Citrate and Placebo at T3||||0.371
72423066|NCT03324880|144356770|SUPERIORITY||Difference in LS Mean|0.55|||=|0.283|TWO_SIDED|95.0|-0.45|1.56|||ANCOVA|From an ANCOVA with treatment group (rhPTH(l-84), placebo) as the predictor and Baseline score as a covariate.||International Shopping List Test Delayed Recall (ISRL)||1.56|-0.45|=0.283
72423067|NCT03324880|144356771|SUPERIORITY||Difference in LS Mean|0.01|||=|0.582|TWO_SIDED|95.0|-0.02|0.04||1-sided p-value was reported.|MMRM|||Detection (DET)|From MMRM with visit, treatment group, and visit treatment group as fixed effects, Baseline score as a covariate, and participant as a random effect. By-participant scores, which are summarized in this table, are derived as the average of the planned at-home assessment values that passed the Completion criteria over 14 days preceding the visit.|0.04|-0.02|=0.582
72423068|NCT03324880|144356771|SUPERIORITY||Difference in LS Mean|0.01|||=|0.492|TWO_SIDED|95.0|-0.02|0.04||1-sided p-value was reported.|MMRM|||Identification (IDN)|From MMRM with visit, treatment group, and visit treatment group as fixed effects, Baseline score as a covariate, and participant as a random effect. By-participant scores, which are summarized in this table, are derived as the average of the planned at-home assessment values that passed the Completion criteria over 14 days preceding the visit.|0.04|-0.02|=0.492
72423069|NCT03324880|144356771|SUPERIORITY||Difference in LS Mean|0.01|||=|0.506|TWO_SIDED|95.0|-0.03|0.06||1-sided p-value was reported.|MMRM|||One Card Learning (OCL)|From MMRM with visit, treatment group, and visit treatment group as fixed effects, Baseline score as a covariate, and participant as a random effect. By-participant scores, which are summarized in this table, are derived as the average of the planned at-home assessment values that passed the Completion criteria over 14 days preceding the visit.|0.06|-0.03|=0.506
72423070|NCT03324880|144356771|SUPERIORITY||Difference in LS Mean|0.01|||=|0.438|TWO_SIDED|95.0|-0.02|0.04||1-sided p-value was reported.|MMRM|||One Back Test|From MMRM with visit, treatment group, and visit treatment group as fixed effects, Baseline score as a covariate, and participant as a random effect. By-participant scores, which are summarized in this table, are derived as the average of the planned at-home assessment values that passed the Completion criteria over 14 days preceding the visit.|0.04|-0.02|=0.438
72423071|NCT03324880|144356772|SUPERIORITY||Difference in LS Mean|2.09|STANDARD_ERROR_OF_MEAN|0.871|=|0.991|TWO_SIDED|95.0|0.36|3.83||1-sided p-value was reported.|MMRM||||MMRM analysis over all post-baseline visits, with the change from baseline in 24-hour urine calcium excretion as the outcome, treatment group, visit, and their interaction as fixed effect factors and participants as a random effect with adjustment for baseline 24-Hour urine calcium excretion.|3.83|0.36|=0.991
72332615|NCT02731820|144189516|OTHER|||||||0.466|||||||t-test, 2 sided|||Independent comparison (unpaired analysis) between Potassium Citrate and Placebo at T6||||0.466
72332616|NCT02731820|144189517|OTHER|||||||0.094|||||||t-test, 1 sided|||Paired analysis within the group to evaluate the effect of Potassium Citrate: T3 vs T0||||0.094
72423072|NCT03324880|144356773|SUPERIORITY||Difference in LS Mean|-0.175|STANDARD_ERROR_OF_MEAN|0.0395|<|0.001|TWO_SIDED|95.0|-0.254|-0.097||1-sided p-value was reported.|MMRM||||MMRM analysis over all post-baseline visits, with the change from baseline in serum phosphate as the outcome, treatment group, visit, and their interaction as fixed effect factors and participants as a random effect with adjustment for baseline serum phosphate.|-0.097|-0.254|<0.001
72423073|NCT03324880|144356774|SUPERIORITY||Difference in LS Mean|4.08|STANDARD_ERROR_OF_MEAN|4.654|=|0.81|TWO_SIDED|95.0|-5.06|13.22||1-sided p-value was reported.|MMRM||||From a mixed-effects model for repeated measures (MMRM) analysis over all post-baseline visits, with the change from baseline in active vitamin D supplement dose as the outcome, treatment group, visit, and their interaction as fixed effect factors and participants as a random effect with adjustment for baseline active vitamin D supplement dose.|13.22|-5.06|=0.810
72332617|NCT02731820|144189517|OTHER|||||||0.0004|||||||t-test, 1 sided|||Paired analysis within the group to evaluate the effect of Potassium Citrate: T6 vs T0||||0.0004
72332618|NCT02731820|144189517|OTHER|||||||0.008|||||||t-test, 1 sided|||Paired analysis within the group to evaluate the effect of Potassium Citrate: T6 vs T3||||0.008
72332619|NCT02731820|144189517|OTHER|||||||0.002|||||||t-test, 1 sided|||Paired analysis within the group to evaluate the effect of Placebo: T3 vs T0||||0.002
72332620|NCT02731820|144189517|OTHER||||||<|0.0001|||||||t-test, 1 sided|||Paired analysis within the group to evaluate the effect of Potassium Citrate: T6 vs T0||||<0.0001
72332621|NCT02731820|144189517|OTHER|||||||0.0007|||||||t-test, 1 sided|||Paired analysis within the group to evaluate the effect of Potassium Citrate: T6 vs T3||||0.0007
72332622|NCT02731820|144189517|OTHER|||||||0.458|||||||t-test, 2 sided|||Independent comparison (unpaired analysis) between Potassium Citrate and Placebo at T0||||0.458
72332623|NCT02731820|144189517|OTHER|||||||0.434|||||||t-test, 2 sided|||Independent comparison (unpaired analysis) between Potassium Citrate and Placebo at T3||||0.434
72332624|NCT02731820|144189517|OTHER|||||||0.555|||||||t-test, 2 sided|||Independent comparison (unpaired analysis) between Potassium Citrate and Placebo at T6||||0.555
72332625|NCT01450696|144189519|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.24||||0.2401|TWO_SIDED|95.0|0.86|1.78|||Log Rank|||Stratified analysis included stratum of creatinine clearance (45 to 59 milliliters per minute \[mL/min\] and greater than or equal to \[≥\] 60 mL/min). Hazard ratio was estimated by Cox regression.||1.78|0.86|0.2401
72332626|NCT01450696|144189519|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.32||||0.1285|TWO_SIDED|95.0|0.92|1.88|||Log Rank|||Unstratified analysis. Hazard ratio was estimated by Cox regression.||1.88|0.92|0.1285
72332627|NCT01450696|144189521|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.0||||0.9931|TWO_SIDED|95.0|0.49|2.04|||Log Rank|||Stratified analysis included stratum of creatinine clearance (45 to 59 mL/min and ≥60 mL/min). Hazard ratio was estimated by Cox regression.||2.04|0.49|0.9931
72332628|NCT01450696|144189521|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.02||||0.9458|TWO_SIDED|95.0|0.52|2.02|||Log Rank|||Unstratified analysis. Hazard ratio was estimated by Cox regression.||2.02|0.52|0.9458
72332629|NCT01450696|144189523|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.13||||0.6759|TWO_SIDED|95.0|0.63|2.02|||Log Rank|||Stratified analysis included stratum of creatinine clearance (45 to 59 mL/min and ≥60 mL/min). Hazard ratio was estimated by Cox regression.||2.02|0.63|0.6759
72332630|NCT01450696|144189523|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.17||||0.5764|TWO_SIDED|95.0|0.67|2.05|||Log Rank|||Unstratified analysis. Hazard ratio was estimated by Cox regression.||2.05|0.67|0.5764
72332631|NCT01450696|144189524|SUPERIORITY_OR_OTHER||Difference in response rates|-7.58||||0.5402|TWO_SIDED|95.0|-31.75|16.6|||Chi-squared|||The 95% CI for difference in response rates was constructed using the normal approximation to the binomial distribution.||16.60|-31.75|0.5402
72332632|NCT01450696|144189524|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.74|||||TWO_SIDED|95.0|0.28|1.96||||||||1.96|0.28|
72332633|NCT01843673|144189543|NON_INFERIORITY_OR_EQUIVALENCE|Statistical significance testing at 5% level of significance, p-value being larger than 0.05 . The p-values for pairwise comparison.||||||1||||||Statistical significance testing at 5% level of significance, p-value being larger than 0.05. The p-values for pairwise comparison lateral and vertical, for OBI and CBCT was 1.00.|t-test, 2 sided|||Pairwise comparison for each direction between each pair of technologies were done using a t test to check if the difference in the recommended shift is more than 2 mm. Clinical significance is based on a 2 mm difference. Statistical significance is determined based on 5% level of significance.||||1.00
72332634|NCT01843673|144189543|NON_INFERIORITY_OR_EQUIVALENCE|Statistical significance testing at 5% level of significance, p-value being larger than 0.05. Those are the p-values for pairwise comparison.||||||1||||||Statistical significance testing at 5% level of significance, p-value being larger than 0.05. The p-values for pairwise comparison lateral and vertical, for OBI and ExacTrac was 1.00.|t-test, 2 sided|||Pairwise comparison for each direction between each pair of technologies were done using a t test to check if the difference in the recommended shift is more than 2 mm. Clinical significance is based on a 2 mm difference. Statistical significance is determined based on 5% level of significance.||||1.00
72332635|NCT00152477|144189547|SUPERIORITY||Difference of response rate|6.4|||=|0.384|TWO_SIDED|95.0|-7.7|20.5||Two-sided Chi-square test. Fisher's Exact test presented when number of responders in a treatment group is \<5.|Cochran-Mantel-Haenszel|||||20.5|-7.7|=0.384
72332636|NCT00152477|144189547|SUPERIORITY||Difference of response rate|6.4|||=|0.409||95.0|-7.7|20.5||CMH test stratified by country and disease stage (3 levels: Stage IIIb without malignant pleural effusion versus Stage IIIb with malignant pleural effusion or Stage IV or recurrent).|Cochran-Mantel-Haenszel|||||20.5|-7.7|=0.409
72332637|NCT00152477|144189547|SUPERIORITY||Difference of response rate|2.6|||=|0.744|TWO_SIDED|95.0|-13.5|18.8||Two-sided Chi-square test. Fisher's Exact test presented when number of responders in a treatment group is \< 5.|Chi-squared|||||18.8|-13.5|=0.744
72423074|NCT03324880|144356775|SUPERIORITY||Difference in LS Mean|-331.3|STANDARD_ERROR_OF_MEAN|132.56|=|0.007|TWO_SIDED|95.0|-594.6|-67.9||1-sided p-value was reported.|MMRM||||MMRM analysis over all post-baseline visits, with the change from baseline in elemental calcium supplement dose as the outcome, treatment group, visit, and their interaction as fixed effect factors and participants as a random effect with adjustment for baseline elemental calcium supplement dose.|-67.9|-594.6|=0.007
72423075|NCT03324880|144356778|SUPERIORITY||Difference in LS Mean|22.33|STANDARD_ERROR_OF_MEAN|3.271|<|0.001|TWO_SIDED|95.0|15.83|28.84||1-sided p-value was reported.|MMRM||||MMRM analysis over all post-baseline visits, with the change from baseline in bone turnover biomarkers as the outcome, treatment group, visit, and their interaction as fixed effect factors and participants as a random effect with adjustment for baseline bone turnover biomarkers.|28.84|15.83|<0.001
72423076|NCT03324880|144356779|SUPERIORITY||Difference in LS Mean|785.5|STANDARD_ERROR_OF_MEAN|113.65|<|0.001|TWO_SIDED|95.0|559.6|1011.3||1-sided p-value was reported.|MMRM||||MMRM analysis over all post-baseline visits, with the change from baseline in bone turnover biomarkers as the outcome, treatment group, visit, and their interaction as fixed effect factors and participants as a random effect with adjustment for baseline bone turnover biomarkers.|1011.3|559.6|<0.001
72423077|NCT03324880|144356780|SUPERIORITY||Difference in LS Mean|56.43|STANDARD_ERROR_OF_MEAN|6.091|<|0.001|TWO_SIDED|95.0|44.33|68.53||1-sided p-value was reported.|MMRM|||Osteocalcin|MMRM analysis over all post-baseline visits, with the change from baseline in bone turnover biomarkers as the outcome, treatment group, visit, and their interaction as fixed effect factors and participants as a random effect with adjustment for baseline bone turnover biomarkers.|68.53|44.33|<0.001
72423078|NCT03324880|144356780|SUPERIORITY||Difference in LS Mean|226.57|STANDARD_ERROR_OF_MEAN|33.425|<|0.001|TWO_SIDED|95.0|160.17|292.98||1-sided p-value was reported.|MMRM|||Procollagen 1 N-Terminal Propeptide|MMRM analysis over all post-baseline visits, with the change from baseline in bone turnover biomarkers as the outcome, treatment group, visit, and their interaction as fixed effect factors and participants as a random effect with adjustment for baseline bone turnover biomarkers.|292.98|160.17|<0.001
72423079|NCT01412801|144356789|SUPERIORITY_OR_OTHER||Vaccine Group Ratios (Serotype Ia)|0.96|||||TWO_SIDED|98.4|0.71|1.3||||||||1.3|0.71|
72423080|NCT01412801|144356789|SUPERIORITY_OR_OTHER||Vaccine Group ratios (Serotype Ia)|0.81|||||TWO_SIDED|98.4|0.6|1.09||||||||1.09|0.6|
72423081|NCT01412801|144356789|SUPERIORITY_OR_OTHER||Vaccine Group ratios (Serotype Ia)|0.84|||||TWO_SIDED|98.4|0.63|1.14||||||||1.14|0.63|
72423082|NCT01412801|144356789|SUPERIORITY_OR_OTHER||Vaccine Group ratios (Serotype Ib)|0.8|||||TWO_SIDED|98.4|0.49|1.29||||||||1.29|0.49|
72423083|NCT01412801|144356789|SUPERIORITY_OR_OTHER||Vaccine Group ratios (Serotype Ib)|1.05|||||TWO_SIDED|98.4|0.65|1.69||||||||1.69|0.65|
72423084|NCT01412801|144356789|SUPERIORITY_OR_OTHER||Vaccine Group ratios (Serotype Ib)|1.32|||||TWO_SIDED|98.4|0.85|2.06||||||||2.06|0.85|
72423085|NCT01412801|144356789|SUPERIORITY_OR_OTHER||Vaccine Group ratios (Serotype III)|1.17|||||TWO_SIDED|98.4|0.66|2.07||||||||2.07|0.66|
72423086|NCT01412801|144356789|SUPERIORITY_OR_OTHER||Vaccine Group ratios (Serotype III)|1.06|||||TWO_SIDED|98.4|0.63|1.78||||||||1.78|0.63|
72423087|NCT01412801|144356789|SUPERIORITY_OR_OTHER||Vaccine Group ratios (Serotype III)|0.91|||||TWO_SIDED|98.4|0.52|1.58||||||||1.58|0.52|
72423088|NCT00116272|144356790|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.77|||||TWO_SIDED|95.0|1.04|7.35|||||Adjusted oddds ratio for major structural defects in women exposed to etanercept in their 1st trimester versus not exposed computed using logistic regression adjusted for propensity score comprised of asthma and maternal height|||7.35|1.04|
72423089|NCT00116272|144356791|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.37|||||TWO_SIDED|95.0|1.02|5.52|||||Adjusted oddds ratio for major structural defects in women exposed to etanercept in their 1st trimester versus not exposed computed using logistic regression adjusted for propensity score comprised of asthma and maternal height|||5.52|1.02|
72423090|NCT00116272|144356792|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.19|||||TWO_SIDED|95.0|0.7|2.01|||||Unadjusted Odds Ratio computed using logistic regression. No adjusted estimate was computed due to no confirmed confounder.|||2.01|0.70|
72423091|NCT00116272|144356794|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.47|||||TWO_SIDED|95.0|0.2|1.12|||||Adjusted HR computed using Cox proportional hazards regression adjusted for propensity score comprised of referral source (3 categories: OTIS, Pharmaceutical Company/Sponsor/HCP, Patient Support Group/Internet/Other), and maternal height.|||1.12|0.20|
72423092|NCT00116272|144356795|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.6|||||TWO_SIDED|95.0|0.86|2.98|||||Adjusted HR computed using Cox proportional hazards regression adjusted for preeclampsia|||2.98|0.86|
72423093|NCT00116272|144356796|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|-0.2|||||TWO_SIDED|95.0|-0.65|0.26|||||Computed using linear regression, directly adjusted for referral source (not collapsed), vitamin use (not collapsed), preeclampsia, and asthma because propensity score adjustment was not balanced.|||0.26|-0.65|
72423094|NCT00116272|144356797|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|21.79|||||TWO_SIDED|95.0|-83.32|126.91|||||Computed using linear regression, directly adjusted for asthma, RA2 severity score at 32 weeks, and disease severity score imputation indicator because propensity score adjustment was not balanced.|||126.91|-83.32|
72423095|NCT00116272|144356798|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|0.1|||||TWO_SIDED|95.0|-0.44|0.63|||||Computed using linear regression, adjusted for propensity score comprised of preeclampsia and asthma.|||0.63|-0.44|
72423096|NCT00116272|144356799|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|-0.09|||||TWO_SIDED|95.0|-0.43|0.26|||||Computed using linear regression, adjusted for maternal age (categorical).|||0.26|-0.43|
72423097|NCT00116272|144356800|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.48|||||TWO_SIDED|95.0|0.22|1.05|||||Computed using logistic regression, adjusted for propensity score comprised of maternal height, referral source (OTIS, Sponsor/HCP, Patient Support Group/Internet/Other), PsO disease severity score at 32 weeks, \& disease severity imputation indicator|||1.05|0.22|
72423098|NCT00116272|144356801|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.72|||||TWO_SIDED|95.0|0.31|1.68|||||Unadjusted Odds Ratio computed using logistic regression. An adjusted estimate was not computed due to the small number of events.|||1.68|0.31|
72332638|NCT00152477|144189547|SUPERIORITY||Difference of response rate|2.6|||=|0.783|TWO_SIDED|95.0|-13.5|18.8||CMH test stratified by country and disease stage (3 levels: Stage IIIb without malignant pleural effusion versus Stage IIIb with malignant pleural effusion or Stage IV or recurrent).|Cochran-Mantel-Haenszel|||||18.8|-13.5|=0.783
72423099|NCT00116272|144356802|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.79|||||TWO_SIDED|95.0|0.4|1.57|||||Computed using logistic regression, adjusted for propensity score comprised of maternal height, referral source (OTIS, Sponsor/HCP, Patient Support Group/Internet/Other), PsO disease severity score at 32 weeks, \& disease severity imputation indicator|||1.57|0.40|
72423100|NCT00116272|144356803|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|0.2|||||TWO_SIDED|95.0|-7.59|7.99|||||Computed using linear regression, adjusted for propensity score comprised of maternal height, vitamin use, primary disease, RA disease severity score at 32 weeks, PsO disease severity score at intake \& 32 weeks, disease severity imputation indicators|||7.99|-7.59|
72423101|NCT00116272|144356804|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|1.53|||||TWO_SIDED|95.0|-5.76|8.81|||||Computed using linear regression, adjusted for propensity score comprised of maternal height, maternal age (categorical), and referral source (3 categories: OTIS, Pharmaceutical Company/Sponsor/HCP, Patient Support Group/Internet/Other).|||8.81|-5.76|
72332639|NCT00152477|144189547|SUPERIORITY||Difference of response rate|10.2|||=|0.234|TWO_SIDED|95.0|-6.8|27.2||Two-sided Chi-square test. Fisher's Exact test presented when number of responders in a treatment group is \< 5.|Chi-squared|||||27.2|-6.8|=0.234
72423102|NCT00116272|144356805|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|0.27|||||TWO_SIDED|95.0|-6.12|6.65|||||Computed using linear regression. Directly adjusted for infant sex and other autoimmune diseases because propensity score adjustment was not balanced.|||6.65|-6.12|
72423103|NCT00116272|144356806|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.78|||||TWO_SIDED|95.0|0.37|1.62|||||Computed using logistic regression, adjusted for propensity score comprised of maternal height, RA disease severity score at 32 weeks, and disease severity score imputation indicator.|||1.62|0.37|
72423104|NCT00116272|144356807|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.17|||||TWO_SIDED|95.0|0.43|3.14|||||Computed using logistic regression, adjusted for propensity score comprised of country (U.S., Canada), primary disease, and maternal height.|||3.14|0.43|
72423105|NCT00116272|144356808|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.88|||||TWO_SIDED|95.0|0.29|2.65|||||Unadjusted Odds Ratio computed using logistic regression. An adjusted estimate was not computed due to the small number of events.|||2.65|0.29|
72423106|NCT00116272|144356809|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.28|||||TWO_SIDED|95.0|0.47|4.02|||||Unadjusted Odds Ratio computed using logistic regression. An adjusted estimate was not computed due to no confirmed confounder.|||4.02|0.47|
72423107|NCT00116272|144356811|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.04|||||TWO_SIDED|95.0|0.65|1.69|||||Unadjusted Odds Ratio computed using logistic regression. An adjusted estimate was not computed due to no confirmed confounder.|||1.69|0.65|
72423108|NCT01987817|144356830|SUPERIORITY||Risk Difference (RD)|60.0|||<|0.0001|TWO_SIDED|95.0|35.0|79.0|||Fisher Exact|||||79|35|<0.0001
72423109|NCT01987817|144356831|SUPERIORITY||Treatment difference|0.912|||<|0.0001|TWO_SIDED|95.0|0.5184|1.3065||The p-value is based on the F-test for treatment effect adjusted for MTD from baseline (log10 mg). The p-value and confidence intervals are based on the normality assumption.|ANCOVA|Least squares means and 95% CIs based on ANCOVA model of change from baseline in MTD at Exit DBPCFC (terms for treatment \& MTD at baseline (log10 mg).||MTD for the baseline and Exit DBPCFC are transformed back to log10 scale before calculations. A value of 0.3 mg is substituted for subjects who could not tolerate the lowest DBPCFC dose before log10 transformation.||1.3065|0.5184|<0.0001
72423110|NCT00682643|144356843|SUPERIORITY_OR_OTHER|||||||0.395||95.0||||Wald Chi-Square test based on a proportional hazards model adjusting for age and baseline value|Wald Chi-square|||||||0.395
72423111|NCT00682643|144356844|SUPERIORITY_OR_OTHER|||||||0.342||95.0||||Wald Chi-Square test based on a proportional hazards model adjusting for age and baseline value|Wald Chi-square|||||||0.342
72423112|NCT02439749|144356910|SUPERIORITY||||||<|0.001||||||p\<0.05 required for significance|ANCOVA|||||||<0.001
72423113|NCT02439749|144356914|SUPERIORITY|||||||0.026||||||p\<0.05 required for significance.|ANCOVA|||||||0.026
72423114|NCT02439749|144356915|SUPERIORITY|||||||0.052||||||p\<0.05 required for significance.|ANCOVA|||||||0.052
72423115|NCT02439749|144356916|SUPERIORITY|||||||0.07||||||p\<0.05 required for significance.|ANCOVA|||||||0.070
72423116|NCT02439749|144356917|SUPERIORITY|||||||0.009||||||p=\<0.05 required for significance.|ANCOVA|||||||0.009
72423117|NCT01353222|144356930|SUPERIORITY||Hazard Ratio (HR)|1.141||||0.6188|TWO_SIDED|95.0|0.679|1.918|||From a stratified log-rank test, stratif||Cox regression model with treatment as the independent variable, stratified by randomization strata. Hazard ratio with control as reference.|||1.918|0.679|0.6188
72423118|NCT01806584|144356954|SUPERIORITY_OR_OTHER_LEGACY|||||||0.138|TWO_SIDED|||||p-value based on log rank test stratified by diabetic status at surgery comparing the 2 treatment groups.|Log Rank|||Analysis of time to loss of patency||||0.138
72423119|NCT01806584|144356955|SUPERIORITY_OR_OTHER_LEGACY|||||||0.312|TWO_SIDED|||||p-value based on log-rank test stratified by diabetic status at surgery comparing the 2 treatment groups.|Log Rank|||Analysis of time to loss of patency||||0.312
72423120|NCT01806584|144356956|SUPERIORITY_OR_OTHER_LEGACY|||||||0.093|TWO_SIDED|||||p-value based on log-rank test stratified by diabetic status at surgery comparing the 2 treatment groups.|Log Rank|||Analysis of time to loss of patency||||0.093
72423121|NCT01806584|144356957|SUPERIORITY_OR_OTHER_LEGACY||Mean treatment difference|0.23|||||TWO_SIDED|95.0|-0.942|1.402||||||||1.402|-0.942|
72423122|NCT02991482|144356980|SUPERIORITY|||||||0.76|||||||Log Rank|||||||0.76
72423123|NCT00871403|144356994|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.75||||0.2647|TWO_SIDED|95.0|0.43|1.28|||Log Rank||The hazard ratios is estimated using a Pike estimator. The estimated value is the hazard ratio comparing Pazopanib 800 mg plus pemetrexed 500 mg/m\^2 to Cisplatin 75 mg/m\^2 plus pemetrexed 500 mg/m\^2.|||1.28|0.43|0.2647
72423124|NCT00871403|144356997|SUPERIORITY_OR_OTHER||percent difference in response|-12.0||||0.2113|TWO_SIDED|95.0|-30.6|7.2|||Binomial asymptotic||The estimated value is the percent difference in the response rate comparing Pazopanib 800 mg plus pemetrexed 500 mg/m\^2 to Cisplatin 75 mg/m\^2 plus pemetrexed 500 mg/m\^2.|||7.2|-30.6|0.2113
72423125|NCT02150837|144357034|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|Within group comparison (for each group) using a non-parametric paired Wilcoxon signed rank test comparing repeated measures in a single sample.||||||<0.0001
72423126|NCT00659984|144357138|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|5.2||||0.363|TWO_SIDED|95.0|-3.4|13.9|||Cochran Armitage Trend Test|||||13.9|-3.4|0.363
72423127|NCT01737684|144357146|SUPERIORITY_OR_OTHER||Geometric least-squares mean ratio|1.27|||||TWO_SIDED|90.0|0.96|1.67|||ANCOVA|||||1.67|0.96|
72423128|NCT01737684|144357149|SUPERIORITY_OR_OTHER||Geometric least-squares mean ratio|1.35|||||TWO_SIDED|90.0|0.88|2.06|||ANCOVA|||||2.06|0.88|
72423129|NCT01691521|144357152|SUPERIORITY_OR_OTHER||Rate Ratio|0.53|||<|0.001|TWO_SIDED|95.0|0.4|0.72||Hochberg procedure with a gamma parameter of 1 used for multiplicity adjustment.|Negative binomial model||Number of exacerbations per year in the mepolizumab 75mg IV arm divided by the number of exacerbations per year in the placebo arm.|||0.72|0.40|<0.001
72332640|NCT00152477|144189547|SUPERIORITY||Difference of response rate|10.2|||=|0.228|TWO_SIDED|95.0|-6.8|27.2||CMH test stratified by country and disease stage (3 levels: Stage IIIb without malignant pleural effusion versus Stage IIIb with malignant pleural effusion or Stage IV or recurrent).|Cochran-Mantel-Haenszel|||||27.2|-6.8|=0.228
72332641|NCT01005316|144189571|SUPERIORITY_OR_OTHER|||||||0.258|||||||Fisher Exact|||The p-value compares Cohort A: Non-Sensitized with Cohort B: Sensitized, Crossmatch Positive.||||0.2580
72332642|NCT01074463|144189629|NON_INFERIORITY_OR_EQUIVALENCE|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|109.18|||||TWO_SIDED|90.0|99.25|120.12|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||120.12|99.25|
72423130|NCT01691521|144357152|SUPERIORITY_OR_OTHER||Rate Ratio|0.47|||<|0.001|TWO_SIDED|95.0|0.35|0.64||Hochberg procedure with a gamma parameter of 1 used for multiplicity adjustment.|Negative binomial model||Number of exacerbations per year in the mepolizumab 100 mg SC arm divided by the number of exacerbations per year in the placebo arm.|||0.64|0.35|<0.001
72423131|NCT03541044|144357204|EQUIVALENCE|Bioequivalence was determined if the 90% CIs of the GMRs for AUC0-t fell completely within the 0.80 - 1.25 range.|Geometric mean ratio|0.95|||||TWO_SIDED|90.0|0.91|1.0|||||GMR= (Prototype mini Lozenge/ Nicorette mini Lozenge)|||1.00|0.91|
72332643|NCT01074463|144189630|NON_INFERIORITY_OR_EQUIVALENCE|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|104.06|||||TWO_SIDED|90.0|98.73|109.68|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||109.68|98.73|
72423132|NCT03541044|144357205|EQUIVALENCE|Bioequivalence was determined if the 90% CIs of the GMRs for AUC(0-inf) fell completely within the 0.80 - 1.25 range.|Geometric Mean Ratio|0.94|||||TWO_SIDED|90.0|0.89|1.0|||||GMR = (Prototype mini Lozenge/Nicorette mini Lozenge)|||1.00|0.89|
72423133|NCT03541044|144357206|EQUIVALENCE|Bioequivalence was determined if the 90% CIs of the GMRs for Cmax fell completely within the 0.80 - 1.25 range.|Geometric Mean Ratio|0.89|||||TWO_SIDED|90.0|0.82|0.98|||||GMR = (Prototype mini Lozenge/Nicorette mini Lozenge)|||0.98|0.82|
72423134|NCT02424591|144357223|SUPERIORITY_OR_OTHER|||||||0.86|||||||Wilcoxon (Mann-Whitney)|||||||0.86
72423135|NCT02424591|144357224|SUPERIORITY_OR_OTHER|||||||0.79|||||||Wilcoxon (Mann-Whitney)|||||||0.79
72423136|NCT02424591|144357225|SUPERIORITY_OR_OTHER|||||||0.74|||||||Wilcoxon (Mann-Whitney)|||||||0.74
72423137|NCT02277743|144357243|SUPERIORITY||difference in percentages|27.7|||<|0.0001|TWO_SIDED|95.0|20.18|35.17||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg q2w vs Placebo|Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity.||35.17|20.18|< 0.0001
72423138|NCT02277743|144357243|SUPERIORITY||difference in percentages|27.0|||<|0.0001|TWO_SIDED|95.0|19.47|34.44||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg qw vs Placebo|Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity.||34.44|19.47|< 0.0001
72423139|NCT02277743|144357244|SUPERIORITY||difference in percentages|36.6|||<|0.0001|TWO_SIDED|95.0|28.58|44.63||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg q2w vs Placebo|A hierarchical testing procedure was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.025 level. Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity.||44.63|28.58|< 0.0001
72423140|NCT02277743|144357244|SUPERIORITY||difference in percentages|37.7|||<|0.0001|TWO_SIDED|95.0|29.7|45.77||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg qw vs Placebo|A hierarchical testing procedure was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.025 level. Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity.||45.77|29.70|< 0.0001
72423141|NCT02277743|144357245|SUPERIORITY||difference in percentages|28.6|||<|0.0001|TWO_SIDED|95.0|20.64|36.52||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg q2w vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||36.52|20.64|< 0.0001
72423142|NCT02277743|144357245|SUPERIORITY||difference in percentages|28.0|||<|0.0001|TWO_SIDED|95.0|19.94|36.13||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg qw vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||36.13|19.94|< 0.0001
72423143|NCT02277743|144357246|SUPERIORITY||difference in percentages|29.6|||<|0.0001|TWO_SIDED|95.0|21.36|37.88||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg q2w vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous outcome measure was statistically significant).||37.88|21.36|< 0.0001
72423144|NCT02277743|144357246|SUPERIORITY||difference in percentages|34.5|||<|0.0001|TWO_SIDED|95.0|26.08|42.84||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg qw vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous outcome measure was statistically significant).||42.84|26.08|< 0.0001
72423145|NCT02277743|144357247|SUPERIORITY||Least square (LS) mean difference|-24.9|||<|0.0001|TWO_SIDED|95.0|-32.26|-17.52||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg q2w vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous outcome measure was statistically significant).||-17.52|-32.26|< 0.0001
72423146|NCT02277743|144357247|SUPERIORITY||LS mean difference|-22.8|||<|0.0001|TWO_SIDED|95.0|-30.33|-15.33||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg qw vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous outcome measure was statistically significant).||-15.33|-30.33|< 0.0001
72423147|NCT02277743|144357248|SUPERIORITY||difference in percentages|9.8||||0.0012|TWO_SIDED|95.0|3.95|15.71||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg q2w vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous outcome measure was statistically significant).||15.71|3.95|0.0012
72423148|NCT02277743|144357248|SUPERIORITY||difference in percentages|17.3|||<|0.0001|TWO_SIDED|95.0|10.57|23.93||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg qw vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous outcome measure was statistically significant).||23.93|10.57|< 0.0001
72423149|NCT02277743|144357249|SUPERIORITY||difference in percentages|6.1||||0.0097|TWO_SIDED|95.0|1.49|10.68||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg q2w vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous outcome measure was statistically significant).||10.68|1.49|0.0097
72423150|NCT02277743|144357249|SUPERIORITY||difference in percentages|6.2||||0.0094|TWO_SIDED|95.0|1.45|10.86||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg qw vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous outcome measure was statistically significant).||10.86|1.45|0.0094
72423151|NCT02277743|144357250|SUPERIORITY||LS mean difference|-1.75|||<|0.0001|TWO_SIDED|95.0|-2.236|-1.26||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg q2w vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous outcome measure was statistically significant).||-1.260|-2.236|< 0.0001
72332644|NCT01074463|144189631|NON_INFERIORITY_OR_EQUIVALENCE|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|102.34|||||TWO_SIDED|90.0|97.78|107.11|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||107.11|97.78|
72423152|NCT02277743|144357250|SUPERIORITY||LS mean difference|-1.69|||<|0.0001|TWO_SIDED|95.0|-2.189|-1.186||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg qw vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous outcome measure was statistically significant).||-1.186|-2.189|< 0.0001
72423153|NCT02277743|144357251|SUPERIORITY||LS mean difference|-34.6|||<|0.0001|TWO_SIDED|95.0|-42.35|-26.88||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg q2w vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous outcome measure was statistically significant).||-26.88|-42.35|< 0.0001
72423154|NCT02277743|144357251|SUPERIORITY||LS mean difference|-34.4|||<|0.0001|TWO_SIDED|95.0|-42.17|-26.56||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg qw vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous outcome measure was statistically significant).||-26.56|-42.17|< 0.0001
72423155|NCT02277743|144357252|SUPERIORITY||difference in percentages|44.2|||<|0.0001|TWO_SIDED|95.0|35.91|52.48||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg q2w vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous outcome measure was statistically significant).||52.48|35.91|< 0.0001
72423156|NCT02277743|144357252|SUPERIORITY||difference in percentages|36.4|||<|0.0001|TWO_SIDED|95.0|27.9|44.96||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg qw vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous outcome measure was statistically significant).||44.96|27.90|< 0.0001
72423157|NCT02277743|144357253|SUPERIORITY||difference in percentages|28.1|||<|0.0001|TWO_SIDED|95.0|20.96|35.29||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg q2w vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous outcome measure was statistically significant).||35.29|20.96|< 0.0001
72332645|NCT01734395|144189632|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.19|STANDARD_DEVIATION|4.56|<|0.0001|TWO_SIDED|95.0|-1.4262|-0.9467|||t-test, 2 sided|||||-0.9467|-1.4262|<.0001
72423158|NCT02277743|144357253|SUPERIORITY||difference in percentages|25.6|||<|0.0001|TWO_SIDED|95.0|18.51|32.68||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg qw vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous outcome measure was statistically significant).||32.68|18.51|< 0.0001
72423159|NCT02277743|144357254|SUPERIORITY||LS mean difference|-17.92|||<|0.0001|TWO_SIDED|95.0|-22.487|-13.353||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg q2w vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous outcome measure was statistically significant).||-13.353|-22.487|< 0.0001
72423160|NCT02277743|144357254|SUPERIORITY||LS mean difference|-18.89|||<|0.0001|TWO_SIDED|95.0|-23.125|-14.65||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg qw vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous outcome measure was statistically significant).||-14.650|-23.125|< 0.0001
72423161|NCT02277743|144357255|SUPERIORITY||LS mean difference|-28.7|||<|0.0001|TWO_SIDED|95.0|-35.79|-21.54||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg q2w vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous outcome measure was statistically significant).||-21.54|-35.79|< 0.0001
72423162|NCT02277743|144357255|SUPERIORITY||LS mean difference|-28.0|||<|0.0001|TWO_SIDED|95.0|-35.09|-20.87||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg qw vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous outcome measure was statistically significant).||-20.87|-35.09|< 0.0001
72423163|NCT02277743|144357256|SUPERIORITY||LS mean difference|-4.0|||<|0.0001|TWO_SIDED|95.0|-5.16|-2.8||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg q2w vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous outcome measure was statistically significant).||-2.80|-5.16|< 0.0001
72423164|NCT02277743|144357256|SUPERIORITY||LS mean difference|-3.7|||<|0.0001|TWO_SIDED|95.0|-4.87|-2.49||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg qw vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous outcome measure was statistically significant).||-2.49|-4.87|< 0.0001
72423165|NCT02277743|144357257|SUPERIORITY||LS mean difference|-6.5|||<|0.0001|TWO_SIDED|95.0|-8.02|-5.01||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg q2w vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-5.01|-8.02|< 0.0001
72423166|NCT02277743|144357257|SUPERIORITY||LS mean difference|-5.9|||<|0.0001|TWO_SIDED|95.0|-7.44|-4.32||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg qw vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous outcome measure was statistically significant).||-4.32|-7.44|< 0.0001
72423167|NCT02277743|144357258|SUPERIORITY||LS mean difference|-2.2||||0.0006|TWO_SIDED|95.0|-3.44|-0.95||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg q2w vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous outcome measure was statistically significant).||-0.95|-3.44|0.0006
72423168|NCT02277743|144357258|SUPERIORITY||LS mean difference|-2.2||||0.0003|TWO_SIDED|95.0|-3.46|-1.03||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg qw vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous outcome measure was statistically significant).||-1.03|-3.46|0.0003
72423169|NCT02277743|144357259|SUPERIORITY||LS mean difference|-27.0|||<|0.0001|TWO_SIDED|95.0|-35.04|-18.91||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg q2w vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous outcome measure was statistically significant).||-18.91|-35.04|< 0.0001
72423170|NCT02277743|144357259|SUPERIORITY||LS mean difference|-25.6|||<|0.0001|TWO_SIDED|95.0|-33.06|-18.12||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg qw vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous outcome measure was statistically significant).||-18.12|-33.06|< 0.0001
72423171|NCT02277743|144357260|SUPERIORITY||LS mean difference|-16.5|||<|0.0001|TWO_SIDED|95.0|-21.08|-11.9||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg q2w vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous outcome measure was statistically significant).||-11.90|-21.08|< 0.0001
72423172|NCT02277743|144357260|SUPERIORITY||LS mean difference|-15.1|||<|0.0001|TWO_SIDED|95.0|-19.62|-10.5||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg qw vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous outcome measure was statistically significant).||-10.50|-19.62|< 0.0001
72423173|NCT03976466|144357293|SUPERIORITY||Risk Ratio (RR)|0.049|||<|0.05|TWO_SIDED|95.0|0.015|0.168|||Chi-squared, Corrected||For the Relative risk the control Study group was the numerator and control group denominator. In the 2X2 contingency table the rows correspond to groups and columns for the presence or abscence of periprosthetic infection.|"H0.- There is no significant difference in the incidence of periprosthetic infection in patients with non-modifiable risk factors and prophylactic application of antibiotic loaded calcium sulfate compared with patients without prophylactic treatment with calcium sulfate.~The presence of periprosthetic infection in both groups was evaluated by chi2 and Lambda tests for dichotomous nominal and qualitative variables with longitudinal direction and relative risk factor test."||0.168|0.015|<0.05
72423174|NCT03976466|144357294|SUPERIORITY||||||<|0.01||||||The statistical test of t was performed for the variable length of hospital stay, finding a significant difference with a p value \< 0.01|t-test, 2 sided|||Lenght of stay was the variable that compares both groups and was a continous variable (t-test).||||<0.01
72423175|NCT01557322|144357295|SUPERIORITY_OR_OTHER|||||||0.01|TWO_SIDED||||||Chi-squared|||Morning Stiffness \> 1 Hour: p-value was calculated using chi-square test.||||0.010
72332646|NCT01734395|144189633|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.48|STANDARD_DEVIATION|10.69|<|0.0001|TWO_SIDED|95.0|0.9188|2.0438|||t-test, 2 sided|||||2.0438|0.9188|<.0001
72332647|NCT01734395|144189634|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.69|STANDARD_DEVIATION|2.43|<|0.0001|TWO_SIDED|95.0|-0.814|-0.5586|||t-test, 2 sided|||||-0.5586|-0.814|<.0001
72423176|NCT01557322|144357295|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Chi-squared|||Arthritis or Deformity of 3 or More Joint Areas: p-value was calculated using chi-square test.||||<0.001
72423177|NCT01557322|144357295|SUPERIORITY_OR_OTHER|||||||0.363|TWO_SIDED||||||Chi-squared|||Arthritis/Deformity of Hand/Joint: p-value was calculated using chi-square test.||||0.363
72423178|NCT01557322|144357295|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Chi-squared|||Symmetry: p-value was calculated using chi-square test.||||<0.001
72423179|NCT01557322|144357295|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Chi-squared|||Nodules: p-value was calculated using chi-square test.||||<0.001
72423180|NCT01557322|144357295|SUPERIORITY_OR_OTHER|||||||0.605|TWO_SIDED||||||Chi-squared|||Rheumatoid Factor Positive: p-value was calculated using chi-square test.||||0.605
72423181|NCT01557322|144357295|SUPERIORITY_OR_OTHER|||||||0.038|TWO_SIDED||||||Chi-squared|||Erosions on Hand or Feet X-Ray: p-value was calculated using chi-square test.||||0.038
72423182|NCT01557322|144357296|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Chi-squared|||Sicca Syndrome: p-value was calculated using chi-square test.||||<0.001
72423183|NCT01557322|144357296|SUPERIORITY_OR_OTHER|||||||0.024|TWO_SIDED||||||Chi-squared|||Serosal Involvement: p-value was calculated using chi-square test.||||0.024
72423184|NCT01557322|144357296|SUPERIORITY_OR_OTHER|||||||0.257|TWO_SIDED||||||Chi-squared|||Eye Involvement: p-value was calculated using chi-square test.||||0.257
72423185|NCT01557322|144357296|SUPERIORITY_OR_OTHER|||||||0.026|TWO_SIDED||||||Chi-squared|||Systemic Vasculitis: p-value was calculated using chi-square test.||||0.026
72423186|NCT01557322|144357296|SUPERIORITY_OR_OTHER|||||||0.725|TWO_SIDED||||||Chi-squared|||Nailfold Vasculitis: p-value was calculated using chi-square test.||||0.725
72423187|NCT01557322|144357296|SUPERIORITY_OR_OTHER|||||||0.22|TWO_SIDED||||||Chi-squared|||Pulmonary Fibrosis: p-value was calculated using chi-square test.||||0.220
72423188|NCT01557322|144357296|SUPERIORITY_OR_OTHER|||||||0.62|TWO_SIDED||||||Chi-squared|||Other: p-value was calculated using chi-square test.||||0.620
72423189|NCT01557322|144357297|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Chi-squared|||Total Knee Replacement: p-value was calculated using chi-square test.||||<0.001
72423190|NCT01557322|144357297|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Chi-squared|||Total Hip Replacement: p-value was calculated using chi-square test.||||<0.001
72423191|NCT01557322|144357297|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Chi-squared|||Total Shoulder Replacement: p-value was calculated using chi-square test.||||<0.001
72423192|NCT01557322|144357297|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Chi-squared|||Total Elbow Replacement: p-value was calculated using chi-square test.||||<0.001
72423193|NCT01557322|144357297|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED||||||Chi-squared|||Wrist/Hand/Ankle/Foot Surgery: p-value was calculated using chi-square test.||||0.001
72423194|NCT01557322|144357297|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Chi-squared|||Neck Surgery: p-value was calculated using chi-square test.||||<0.001
72423195|NCT01557322|144357298|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Chi-squared|||P-value was calculated using chi-square test.||||<0.001
72423196|NCT01557322|144357299|SUPERIORITY_OR_OTHER|||||||0.381|TWO_SIDED||||||Chi-squared|||High Blood Pressure: p-value was calculated using chi-square test.||||0.381
72423197|NCT01557322|144357299|SUPERIORITY_OR_OTHER|||||||0.006|TWO_SIDED||||||Chi-squared|||Angina: p-value was calculated using chi-square test.||||0.006
72423198|NCT01557322|144357299|SUPERIORITY_OR_OTHER|||||||0.215|TWO_SIDED||||||Chi-squared|||Heart Attack: p-value was calculated using chi-square test.||||0.215
72423199|NCT01557322|144357299|SUPERIORITY_OR_OTHER|||||||0.117|TWO_SIDED||||||Chi-squared|||Stroke: p-value was calculated using chi-square test.||||0.117
72423200|NCT01557322|144357299|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Chi-squared|||Epilepsy: p-value was calculated using chi-square test.||||1.000
72423201|NCT01557322|144357299|SUPERIORITY_OR_OTHER|||||||0.542|TWO_SIDED||||||Chi-squared|||Asthma: p-value was calculated using chi-square test.||||0.542
72423202|NCT01557322|144357299|SUPERIORITY_OR_OTHER|||||||0.027|TWO_SIDED||||||Chi-squared|||Chronic Bronchitis/Emphysema: p-value was calculated using chi-square test.||||0.027
72423203|NCT01557322|144357299|SUPERIORITY_OR_OTHER|||||||0.566|TWO_SIDED||||||Chi-squared|||Peptic Ulcer: p-value was calculated using chi-square test.||||0.566
72423204|NCT01557322|144357299|SUPERIORITY_OR_OTHER|||||||0.003|TWO_SIDED||||||Chi-squared|||Liver Disease: p-value was calculated using chi-square test.||||0.003
72423205|NCT01557322|144357299|SUPERIORITY_OR_OTHER|||||||0.526|TWO_SIDED||||||Chi-squared|||Renal Disease: p-value was calculated using chi-square test.||||0.526
72423206|NCT01557322|144357299|SUPERIORITY_OR_OTHER|||||||0.802|TWO_SIDED||||||Chi-squared|||Tuberculosis: p-value was calculated using chi-square test.||||0.802
72423207|NCT01557322|144357299|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Chi-squared|||Demyelination: p-value was calculated using chi-square test.||||1.000
72423208|NCT01557322|144357299|SUPERIORITY_OR_OTHER|||||||0.385|TWO_SIDED||||||Chi-squared|||Diabetes: p-value was calculated using chi-square test.||||0.385
72423209|NCT01557322|144357299|SUPERIORITY_OR_OTHER|||||||0.048|TWO_SIDED||||||Chi-squared|||Hyperthyroidism: p-value was calculated using chi-square test.||||0.048
72423210|NCT01557322|144357299|SUPERIORITY_OR_OTHER|||||||0.308|TWO_SIDED||||||Chi-squared|||Depression: p-value was calculated using chi-square test.||||0.308
72423211|NCT01557322|144357299|SUPERIORITY_OR_OTHER|||||||0.033|TWO_SIDED||||||Chi-squared|||Cancer: p-value was calculated using chi-square test.||||0.033
72423212|NCT01557322|144357300|SUPERIORITY_OR_OTHER|||||||0.188|TWO_SIDED||||||t-test, 2 sided|||P-value was calculated using 2-sided t-test.||||0.188
72423213|NCT01557322|144357301|SUPERIORITY_OR_OTHER|||||||0.016|TWO_SIDED||||||t-test, 2 sided|||Systolic Blood Pressure: p-value was calculated using 2-sided t-test.||||0.016
72423214|NCT01557322|144357301|SUPERIORITY_OR_OTHER|||||||0.369|TWO_SIDED||||||t-test, 2 sided|||Diastolic Blood Pressure: p-value was calculated using 2-sided t-test.||||0.369
72423215|NCT01557322|144357302|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||t-test, 2 sided|||Baseline: p-value was calculated using 2-sided t-test.||||<0.001
72423216|NCT01557322|144357302|SUPERIORITY_OR_OTHER|||||||0.3746|TWO_SIDED||||||Regression, Linear|||Change at Month 60: p-value was calculated using multivariate linear regression with baseline DAS28 score and other baseline variables (socio-demographics, disease characteristics, and initial treatment profile) as covariates.||||0.3746
72423217|NCT01557322|144357303|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||t-test, 2 sided|||Baseline: p-value was calculated using 2-sided t-test.||||<0.001
72423218|NCT01557322|144357304|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||t-test, 2 sided|||Baseline: p-value was calculated using 2-sided t-test.||||<0.001
72423219|NCT01557322|144357305|SUPERIORITY_OR_OTHER|||||||0.154|TWO_SIDED||||||t-test, 2 sided|||Baseline: p-value was calculated using 2-sided t-test.||||0.154
72423220|NCT01557322|144357306|SUPERIORITY_OR_OTHER|||||||0.108|TWO_SIDED||||||t-test, 2 sided|||Baseline: p-value was calculated using 2-sided t-test.||||0.108
72423221|NCT01557322|144357307|SUPERIORITY_OR_OTHER|||||||0.199|TWO_SIDED||||||t-test, 2 sided|||Baseline: p-value was calculated using 2-sided t-test.||||0.199
72423222|NCT01557322|144357308|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||t-test, 2 sided|||P-value was calculated using 2-sided t-test.||||<0.001
72423223|NCT01557322|144357309|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||t-test, 2 sided|||P-value was calculated using 2-sided t-test.||||<0.001
72423224|NCT01557322|144357311|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Chi-squared|||Current DMARDs, Methotrexate: p-value was calculated using chi-square test.||||<0.001
72423225|NCT01557322|144357311|SUPERIORITY_OR_OTHER|||||||0.313|TWO_SIDED||||||Chi-squared|||Current DMARDs, Azathioprine: p-value was calculated using chi-square test.||||0.313
72423226|NCT01557322|144357311|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Chi-squared|||Current DMARDs, Cyclophosphamide: p-value was calculated using chi-square test.||||1.000
72423227|NCT01557322|144357311|SUPERIORITY_OR_OTHER|||||||0.066|TWO_SIDED||||||Chi-squared|||Current DMARDs, Cyclosporine: p-value was calculated using chi-square test.||||0.066
72423228|NCT01557322|144357311|SUPERIORITY_OR_OTHER|||||||0.099|TWO_SIDED||||||Chi-squared|||Current DMARDs, Leflunomide: p-value was calculated using chi-square test.||||0.099
72423229|NCT01557322|144357311|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Chi-squared|||Current DMARDs, Sulphasalazine: p-value was calculated using chi-square test.||||<0.001
72423230|NCT01557322|144357311|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Chi-squared|||Previous DMARDs, Methotrexate: p-value was calculated using chi-square test.||||<0.001
72423231|NCT01557322|144357311|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Chi-squared|||Previous DMARDs, Azathioprine: p-value was calculated using chi-square test.||||<0.001
72423232|NCT01557322|144357311|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Chi-squared|||Previous DMARDs, Cyclophosphamide: p-value was calculated using chi-square test.||||<0.001
72423233|NCT01557322|144357311|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Chi-squared|||Previous DMARDs, Cyclosporine: p-value was calculated using chi-square test.||||<0.001
72423234|NCT01557322|144357311|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Chi-squared|||Previous DMARDs, Leflunomide: p-value was calculated using chi-square test.||||<0.001
72423235|NCT01557322|144357312|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||t-test, 2 sided|||Baseline: p-value was calculated using 2-sided t-test.||||<0.001
72423236|NCT01557322|144357313|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||t-test, 2 sided|||Baseline PCS: p-value was calculated using 2-sided t-test.||||<0.001
72423237|NCT01557322|144357313|SUPERIORITY_OR_OTHER|||||||0.886|TWO_SIDED||||||t-test, 2 sided|||Baseline MCS: p-value was calculated using 2-sided t-test.||||0.886
72423238|NCT01557322|144357313|SUPERIORITY_OR_OTHER|||||||0.68|TWO_SIDED||||||t-test, 2 sided|||Baseline Vitality Score: p-value was calculated using 2-sided t-test.||||0.680
72423239|NCT01557322|144357323|SUPERIORITY_OR_OTHER|||||||0.0233|TWO_SIDED||||||Chi-squared|||Month 6: p-value was calculated using chi-square test.||||0.0233
72423240|NCT01557322|144357323|SUPERIORITY_OR_OTHER|||||||0.5103|TWO_SIDED||||||Chi-squared|||Month 12: p-value was calculated using chi-square test.||||0.5103
72423241|NCT01557322|144357323|SUPERIORITY_OR_OTHER|||||||0.999|TWO_SIDED||||||Chi-squared|||Month 18: p-value was calculated using chi-square test.||||0.9990
72423242|NCT01557322|144357323|SUPERIORITY_OR_OTHER|||||||0.6495|TWO_SIDED||||||Chi-squared|||Month 24: p-value was calculated using chi-square test.||||0.6495
72423243|NCT01557322|144357323|SUPERIORITY_OR_OTHER|||||||0.3829|TWO_SIDED||||||Chi-squared|||Month 30: p-value was calculated using chi-square test.||||0.3829
72423244|NCT01557322|144357323|SUPERIORITY_OR_OTHER|||||||0.1085|TWO_SIDED||||||Chi-squared|||Month 36: p-value was calculated using chi-square test.||||0.1085
72423245|NCT01557322|144357323|SUPERIORITY_OR_OTHER|||||||0.0472|TWO_SIDED||||||Chi-squared|||Month 48: p-value was calculated using chi-square test.||||0.0472
72423246|NCT01557322|144357323|SUPERIORITY_OR_OTHER|||||||0.4804|TWO_SIDED||||||Chi-squared|||Month 60: p-value was calculated using chi-square test.||||0.4804
72423247|NCT01557322|144357324|SUPERIORITY_OR_OTHER|||||||0.0895|TWO_SIDED||||||Chi-squared|||Lymphoproliferative Tumors, Month 6: p-value was calculated using chi-square test.||||0.0895
72423248|NCT01557322|144357324|SUPERIORITY_OR_OTHER|||||||0.0774|TWO_SIDED||||||Chi-squared|||Lymphoproliferative Tumors, Month 12: p-value was calculated using chi-square test.||||0.0774
72423249|NCT01557322|144357324|SUPERIORITY_OR_OTHER|||||||0.0024|TWO_SIDED||||||Chi-squared|||Lymphoproliferative Tumors, Month 18: p-value was calculated using chi-square test.||||0.0024
72423250|NCT01557322|144357324|SUPERIORITY_OR_OTHER|||||||0.5552|TWO_SIDED||||||Chi-squared|||Lymphoproliferative Tumors, Month 30: p-value was calculated using chi-square test.||||0.5552
72423251|NCT01557322|144357324|SUPERIORITY_OR_OTHER|||||||0.0793|TWO_SIDED||||||Chi-squared|||Lymphoproliferative Tumors, Month 36: p-value was calculated using chi-square test.||||0.0793
72423252|NCT01557322|144357324|SUPERIORITY_OR_OTHER|||||||0.0075|TWO_SIDED||||||Chi-squared|||Lymphoproliferative Tumors, Month 48: p-value was calculated using chi-square test.||||0.0075
72423253|NCT01557322|144357324|SUPERIORITY_OR_OTHER|||||||0.0895|TWO_SIDED||||||Chi-squared|||Hodgkins Lymphoma, Month 6: p-value was calculated using chi-square test.||||0.0895
72423254|NCT01557322|144357324|SUPERIORITY_OR_OTHER|||||||0.0024|TWO_SIDED||||||Chi-squared|||Hodgkins Lymphoma, Month 18: p-value was calculated using chi-square test.||||0.0024
72423255|NCT01557322|144357324|SUPERIORITY_OR_OTHER|||||||0.6301|TWO_SIDED||||||Chi-squared|||Hodgkins Lymphoma, Month 30: p-value was calculated using chi-square test.||||0.6301
72423256|NCT01557322|144357324|SUPERIORITY_OR_OTHER|||||||0.0793|TWO_SIDED||||||Chi-squared|||Hodgkins Lymphoma, Month 36: p-value was calculated using chi-square test.||||0.0793
72423257|NCT01557322|144357324|SUPERIORITY_OR_OTHER|||||||0.0075|TWO_SIDED||||||Chi-squared|||Hodgkins Lymphoma, Month 48: p-value was calculated using chi-square test.||||0.0075
72423258|NCT01557322|144357324|SUPERIORITY_OR_OTHER|||||||0.7253|TWO_SIDED||||||Chi-squared|||Myeloma, Month 12: p-value was calculated using chi-square test.||||0.7253
72423259|NCT01557322|144357324|SUPERIORITY_OR_OTHER|||||||0.7336|TWO_SIDED||||||Chi-squared|||Myeloma, Month 30: p-value was calculated using chi-square test.||||0.7336
72423260|NCT01557322|144357324|SUPERIORITY_OR_OTHER|||||||0.0044|TWO_SIDED||||||Chi-squared|||Leukaemia, Month 12: p-value was calculated using chi-square test.||||0.0044
72423261|NCT01557322|144357324|SUPERIORITY_OR_OTHER|||||||0.4175|TWO_SIDED||||||Chi-squared|||Non-Melanoma Skin Cancer, Month 6: p-value was calculated using chi-square test.||||0.4175
72423262|NCT01557322|144357324|SUPERIORITY_OR_OTHER|||||||0.3886|TWO_SIDED||||||Chi-squared|||Non-Melanoma Skin Cancer, Month 12: p-value was calculated using chi-square test.||||0.3886
72423263|NCT01557322|144357324|SUPERIORITY_OR_OTHER|||||||0.5102|TWO_SIDED||||||Chi-squared|||Non-Melanoma Skin Cancer, Month 18: p-value was calculated using chi-square test.||||0.5102
72423264|NCT01557322|144357324|SUPERIORITY_OR_OTHER|||||||0.9855|TWO_SIDED||||||Chi-squared|||Non-Melanoma Skin Cancer, Month 24: p-value was calculated using chi-square test.||||0.9855
72423265|NCT01557322|144357324|SUPERIORITY_OR_OTHER|||||||0.4955|TWO_SIDED||||||Chi-squared|||Non-Melanoma Skin Cancer, Month 30: p-value was calculated using chi-square test.||||0.4955
72423266|NCT01557322|144357324|SUPERIORITY_OR_OTHER|||||||0.5404|TWO_SIDED||||||Chi-squared|||Non-Melanoma Skin Cancer, Month 36: p-value was calculated using chi-square test.||||0.5404
72423267|NCT01557322|144357324|SUPERIORITY_OR_OTHER|||||||0.3581|TWO_SIDED||||||Chi-squared|||Non-Melanoma Skin Cancer, Month 48: p-value was calculated using chi-square test.||||0.3581
72423268|NCT01557322|144357324|SUPERIORITY_OR_OTHER|||||||0.4932|TWO_SIDED||||||Chi-squared|||Solid Tumor, Month 6: p-value was calculated using chi-square test.||||0.4932
72423269|NCT01557322|144357324|SUPERIORITY_OR_OTHER|||||||0.4818|TWO_SIDED||||||Chi-squared|||Solid Tumor, Month 12: p-value was calculated using chi-square test.||||0.4818
72423270|NCT01557322|144357324|SUPERIORITY_OR_OTHER|||||||0.3224|TWO_SIDED||||||Chi-squared|||Solid Tumor, Month 18: p-value was calculated using chi-square test.||||0.3224
72423271|NCT01557322|144357324|SUPERIORITY_OR_OTHER|||||||0.5003|TWO_SIDED||||||Chi-squared|||Solid Tumor, Month 24: p-value was calculated using chi-square test.||||0.5003
72423272|NCT01557322|144357324|SUPERIORITY_OR_OTHER|||||||0.1134|TWO_SIDED||||||Chi-squared|||Solid Tumor, Month 30: p-value was calculated using chi-square test.||||0.1134
72423273|NCT01557322|144357324|SUPERIORITY_OR_OTHER|||||||0.3488|TWO_SIDED||||||Chi-squared|||Solid Tumor, Month 36: p-value was calculated using chi-square test.||||0.3488
72423274|NCT01557322|144357324|SUPERIORITY_OR_OTHER|||||||0.187|TWO_SIDED||||||Chi-squared|||Solid Tumor, Month 48: p-value was calculated using chi-square test.||||0.1870
72423275|NCT01557322|144357324|SUPERIORITY_OR_OTHER|||||||0.427|TWO_SIDED||||||Chi-squared|||Solid Tumor, Month 60: p-value was calculated using chi-square test.||||0.4270
72423276|NCT01557322|144357325|SUPERIORITY_OR_OTHER|||||||0.5817|TWO_SIDED||||||Chi-squared|||Death Due to AE, Month 6: p-value was calculated using chi-square test.||||0.5817
72423277|NCT01557322|144357325|SUPERIORITY_OR_OTHER|||||||0.2595|TWO_SIDED||||||Chi-squared|||Death Due to AE, Month 12: p-value was calculated using chi-square test.||||0.2595
72423278|NCT01557322|144357325|SUPERIORITY_OR_OTHER|||||||0.5642|TWO_SIDED||||||Chi-squared|||Death Due to AE, Month 18: p-value was calculated using chi-square test.||||0.5642
72423279|NCT01557322|144357325|SUPERIORITY_OR_OTHER|||||||0.0034|TWO_SIDED||||||Chi-squared|||Death Due to AE, Month 24: p-value was calculated using chi-square test.||||0.0034
72423280|NCT01557322|144357325|SUPERIORITY_OR_OTHER|||||||0.7137|TWO_SIDED||||||Chi-squared|||Death Due to AE, Month 36: p-value was calculated using chi-square test.||||0.7137
72423281|NCT01557322|144357325|SUPERIORITY_OR_OTHER|||||||0.963|TWO_SIDED||||||Chi-squared|||Death Due to AE, Month 60: p-value was calculated using chi-square test.||||0.9630
72332648|NCT00758264|144189650|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit (LL) of the 95% confidence interval (CI) of the geometric mean concentration (GMC) ratio between the Nimenrix +Synflorix Group and the Synflorix Group (Nimenrix + Synflorix Group over Synflorix Group) is above (\>) 0.5.|Adjusted GMC ratio|0.87|||||TWO_SIDED|95.0|0.72|1.05||||||Demonstration of non-inferiority of Synflorix vaccine when co-administered with Nimenrix conjugate vaccine versus Synflorix vaccine given alone (Nimenrix conjugate vaccine was administered 1 month later) in terms of anti-pneumococcal serotype 1 antibody concentrations.||1.05|0.72|
72332649|NCT00758264|144189650|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit (LL) of the 95% confidence interval (CI) of the geometric mean concentration (GMC) ratio between the Nimenrix +Synflorix Group and the Synflorix Group (Nimenrix + Synflorix Group over Synflorix Group) is above (\>) 0.5.|Adjusted GMC ratio|1.03|||||TWO_SIDED|95.0|0.84|1.26||||||Demonstration of non-inferiority of Synflorix vaccine when co-administered with Nimenrix conjugate vaccine versus Synflorix vaccine given alone (Nimenrix conjugate vaccine was administered 1 month later) in terms of anti-pneumococcal serotype 4 antibody concentrations.||1.26|0.84|
72423282|NCT01557322|144357325|SUPERIORITY_OR_OTHER|||||||0.7353|TWO_SIDED||||||Chi-squared|||Hospitalization Due to AE, Month 6: p-value was calculated using chi-square test.||||0.7353
72423283|NCT01557322|144357325|SUPERIORITY_OR_OTHER|||||||0.3829|TWO_SIDED||||||Chi-squared|||Hospitalization Due to AE, Month 12: p-value was calculated using chi-square test.||||0.3829
72423284|NCT01557322|144357325|SUPERIORITY_OR_OTHER|||||||0.4532|TWO_SIDED||||||Chi-squared|||Hospitalization Due to AE, Month 18: p-value was calculated using chi-square test.||||0.4532
72423285|NCT01557322|144357325|SUPERIORITY_OR_OTHER|||||||0.4238|TWO_SIDED||||||Chi-squared|||Hospitalization Due to AE, Month 24: p-value was calculated using chi-square test.||||0.4238
72332650|NCT00758264|144189650|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit (LL) of the 95% confidence interval (CI) of the geometric mean concentration (GMC) ratio between the Nimenrix +Synflorix Group and the Synflorix Group (Nimenrix + Synflorix Group over Synflorix Group) is above (\>) 0.5.|Adjusted GMC ratio|0.9|||||TWO_SIDED|95.0|0.74|1.1||||||Demonstration of non-inferiority of Synflorix vaccine when co-administered with Nimenrix conjugate vaccine versus Synflorix vaccine given alone (Nimenrix conjugate vaccine was administered 1 month later) in terms of anti-pneumococcal serotype 5 antibody concentrations.||1.10|0.74|
72423286|NCT01557322|144357325|SUPERIORITY_OR_OTHER|||||||0.1218|TWO_SIDED||||||Chi-squared|||Hospitalization Due to AE, Month 30: p-value was calculated using chi-square test.||||0.1218
72423287|NCT01557322|144357325|SUPERIORITY_OR_OTHER|||||||0.4124|TWO_SIDED||||||Chi-squared|||Hospitalization Due to AE, Month 36: p-value was calculated using chi-square test.||||0.4124
72423288|NCT01557322|144357325|SUPERIORITY_OR_OTHER|||||||0.6356|TWO_SIDED||||||Chi-squared|||Hospitalization Due to AE, Month 48: p-value was calculated using chi-square test.||||0.6356
72423289|NCT01557322|144357325|SUPERIORITY_OR_OTHER|||||||0.5491|TWO_SIDED||||||Chi-squared|||Hospitalization Due to AE, Month 60: p-value was calculated using chi-square test.||||0.5491
72423290|NCT01557322|144357326|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Regression, Linear|||P-value was calculated using multivariate linear regression with baseline DAS28 score and other baseline variables (socio-demographics, disease characteristics, and initial treatment profile) as covariates.||||<0.0001
72423291|NCT01557322|144357327|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Regression, Linear|||P-value was calculated using multivariate linear regression with baseline HAQ-DI score and other baseline variables (socio-demographics, disease characteristics, and initial treatment profile) as covariates.||||<0.0001
72332651|NCT00758264|144189650|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit (LL) of the 95% confidence interval (CI) of the geometric mean concentration (GMC) ratio between the Nimenrix +Synflorix Group and the Synflorix Group (Nimenrix + Synflorix Group over Synflorix Group) is above (\>) 0.5.|Adjusted GMC ratio|0.84|||||TWO_SIDED|95.0|0.66|1.07||||||Demonstration of non-inferiority of Synflorix vaccine when co-administered with Nimenrix conjugate vaccine versus Synflorix vaccine given alone (Nimenrix conjugate vaccine was administered 1 month later) in terms of anti-pneumococcal serotype 6B antibody concentrations.||1.07|0.66|
72332652|NCT00758264|144189650|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit (LL) of the 95% confidence interval (CI) of the geometric mean concentration (GMC) ratio between the Nimenrix +Synflorix Group and the Synflorix Group (Nimenrix + Synflorix Group over Synflorix Group) is above (\>) 0.5.|Adjusted GMC ratio|1.0|||||TWO_SIDED|95.0|0.84|1.2||||||Demonstration of non-inferiority of Synflorix vaccine when co-administered with Nimenrix conjugate vaccine versus Synflorix vaccine given alone (Nimenrix conjugate vaccine was administered 1 month later) in terms of anti-pneumococcal serotype 7F antibody concentrations.||1.20|0.84|
72423292|NCT01557322|144357328|SUPERIORITY_OR_OTHER|||||||0.2558|TWO_SIDED||||||Regression, Linear|||PCS: p-value was calculated using multivariate linear regression with baseline PCS and other baseline variables (socio-demographics, disease characteristics, and initial treatment profile) as covariates.||||0.2558
72423293|NCT01557322|144357328|SUPERIORITY_OR_OTHER|||||||0.4908|TWO_SIDED||||||Regression, Linear|||MCS: p-value was calculated using multivariate linear regression with baseline MCS and other baseline variables (socio-demographics, disease characteristics, and initial treatment profile) as covariates.||||0.4908
72332653|NCT00758264|144189650|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit (LL) of the 95% confidence interval (CI) of the geometric mean concentration (GMC) ratio between the Nimenrix +Synflorix Group and the Synflorix Group (Nimenrix + Synflorix Group over Synflorix Group) is above (\>) 0.5.|Adjusted GMC ratio|0.94|||||TWO_SIDED|95.0|0.78|1.14||||||Demonstration of non-inferiority of Synflorix vaccine when co-administered with Nimenrix conjugate vaccine versus Synflorix vaccine given alone (Nimenrix conjugate vaccine was administered 1 month later) in terms of anti-pneumococcal serotype 9V antibody concentrations.||1.14|0.78|
72332654|NCT00758264|144189650|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit (LL) of the 95% confidence interval (CI) of the geometric mean concentration (GMC) ratio between the Nimenrix +Synflorix Group and the Synflorix Group (Nimenrix + Synflorix Group over Synflorix Group) is above (\>) 0.5.|Adjusted GMC ratio|0.98|||||TWO_SIDED|95.0|0.78|1.23||||||Demonstration of non-inferiority of Synflorix vaccine when co-administered with Nimenrix conjugate vaccine versus Synflorix vaccine given alone (Nimenrix conjugate vaccine was administered 1 month later) in terms of anti-pneumococcal serotype 14 antibody concentrations.||1.23|0.78|
72423294|NCT01557322|144357328|SUPERIORITY_OR_OTHER|||||||0.8379|TWO_SIDED||||||Regression, Linear|||Vitality Score: p-value was calculated using multivariate linear regression with baseline vitality score and other baseline variables (socio-demographics, disease characteristics, and initial treatment profile) as covariates.||||0.8379
72423295|NCT02247336|144357330|SUPERIORITY||Odds Ratio (OR)|0.7||||0.16|TWO_SIDED|95.0|0.4|1.2||A priori threshold was 0.05.|Regression, Logistic|generalized estimating equation|Generalized estimating equation models were used with a logit link function and an exchangeable correlation structure to account for clustering of participants within provider. Fay and Graubard small sample bias correction was applied.|Using alpha=0.05, 80% power, and a risk-appropriate screening referral rate for the delayed arm ranging from 60% to 70%, n = 250 participants with a completed a family health history assessment per arm with 40 providers was needed to detect differences between arms in appropriate referral ranging from 12% to 13.2%. Sample size calculations accounted for provider clustering using an intra-class correlation coefficient of 0.02 to adjust variance for a Z-test of the difference of two proportions.||1.2|0.4|0.16
72423296|NCT02247336|144357331|SUPERIORITY||Odds Ratio (OR)|0.7||||0.23|TWO_SIDED|95.0|0.04|1.2||The a priori threshold was 0.05.|Regression, Logistic|generalized estimating equation|Generalized estimating equation models were used with a logit link function and an exchangeable correlation structure to account for clustering of participants within provider. Fay and Graubard small sample bias correction was applied.|||1.2|.04|0.23
72423297|NCT00733499|144357333|OTHER|||||||0.9478|||||||t-test, 2 sided|||||||0.9478
72423298|NCT00733499|144357334|OTHER|||||||0.549|||||||t-test, 2 sided|||||||0.5490
72423299|NCT00733499|144357335|OTHER|||||||0.5312|||||||t-test, 2 sided|||||||0.5312
72423300|NCT00733499|144357336|OTHER|||||||0.3549|||||||t-test, 2 sided|||||||0.3549
72423301|NCT00733499|144357337|OTHER|||||||0.0513|||||||t-test, 2 sided|||||||0.0513
72423302|NCT00733499|144357338|OTHER|||||||0.0629|||||||t-test, 2 sided|||||||0.0629
72423303|NCT00733499|144357339|OTHER|||||||0.0327|||||||t-test, 2 sided|||||||0.0327
72423304|NCT00733499|144357340|OTHER|||||||0.0883|||||||t-test, 2 sided|||||||0.0883
72423305|NCT00733499|144357341|OTHER|||||||0.6801|||||||Wilcoxon (Mann-Whitney)|||||||0.6801
72423306|NCT00733499|144357342|OTHER|||||||0.4779|||||||t-test, 2 sided|||||||0.4779
72423307|NCT00733499|144357343|OTHER|||||||0.8007|||||||t-test, 2 sided|||||||0.8007
72423308|NCT00733499|144357344|OTHER|||||||0.3317|||||||t-test, 2 sided|||||||0.3317
72423309|NCT00733499|144357345|OTHER|||||||0.8955|||||||t-test, 2 sided|||||||0.8955
72423310|NCT00733499|144357346|OTHER|||||||0.2116|||||||t-test, 2 sided|||||||0.2116
72423311|NCT00733499|144357347|OTHER|||||||0.4776|||||||t-test, 2 sided|||||||0.4776
72423312|NCT00733499|144357349|OTHER|||||||0.2935|||||||t-test, 2 sided|||||||0.2935
72423313|NCT00733499|144357350|OTHER|||||||0.0062|||||||Wilcoxon (Mann-Whitney)|||||||0.0062
72423314|NCT00733499|144357351|OTHER|||||||0.6896|||||||t-test, 2 sided|||||||0.6896
72423315|NCT00733499|144357352|OTHER|||||||0.1076|||||||t-test, 2 sided|||||||0.1076
72423316|NCT00733499|144357353|OTHER|||||||0.9042|||||||t-test, 2 sided|||||||0.9042
72423317|NCT00733499|144357354|OTHER|||||||0.9637|||||||t-test, 2 sided|||||||0.9637
72423318|NCT00733499|144357355|OTHER|||||||0.0485|||||||t-test, 2 sided|||||||0.0485
72423319|NCT00733499|144357356|OTHER|||||||0.9813|||||||t-test, 2 sided|||||||0.9813
72423320|NCT03682705|144357379|SUPERIORITY||LS Mean Difference|-1.44|STANDARD_ERROR_OF_MEAN|0.36|<|0.001|TWO_SIDED|90.0|-2.03|-0.85|||t-test, 2 sided|||Mixed-Effect Model Repeated Measure (MMRM) analysis was conducted, testing the superiority of the combination of upadacitinib 15 mg and elsubrutinib 60 mg compared to placebo at Week 12. Data collected after a participant discontinued study drug was considered as missing. The mixed model included the categorical fixed effects of treatment, visit and treatment-by-visit interaction, prior bDMARD use, and baseline DAS28 (CRP) measurement.||-0.85|-2.03|<0.001
72423321|NCT01874145|144357461|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.501|STANDARD_ERROR_OF_MEAN|0.101||0.0006|TWO_SIDED|95.0|0.338|0.743||The overall significance level for this study was 5% using 2-tailed test.|Poisson regression model|Natural log of treatment duration was an offset variable; adjusted for baseline EDSS, treatment group, age, sex, # relapses 2 years prior to screening|GA 40 mg/mL TIW treatment group / GA 20 mg/mL QD treatment group.|Adjusted mean estimates were adjusted estimates of event rates within treatment group. The treatment effect parameter estimate was a risk ratio of the GA 40 mg/mL TIW treatment group divided by the GA 20 mg/mL QD treatment group. The p value tested whether the risk ratio was significantly different from 1.||0.743|0.338|0.0006
72423322|NCT01874145|144357463|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.5|STANDARD_ERROR_OF_MEAN|0.101||0.0006|TWO_SIDED|95.0|0.337|0.742||The overall significance level for this study was 5% using 2-tailed test.|Poisson regression model|Natural log of treatment duration was an offset variable; adjusted for baseline EDSS, treatment group, age, sex, # relapses 2 years prior to screening|GA 40 mg/mL TIW treatment group / GA 20 mg/mL QD treatment group|Adjusted mean estimates were adjusted estimates of event rates within treatment group. The treatment effect parameter estimate was a risk ratio of the GA 40 mg/mL TIW treatment group divided by the GA 20 mg/mL QD treatment group. The p value tested whether the risk ratio was significantly different from 1.||0.742|0.337|0.0006
72332655|NCT00758264|144189650|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit (LL) of the 95% confidence interval (CI) of the geometric mean concentration (GMC) ratio between the Nimenrix +Synflorix Group and the Synflorix Group (Nimenrix + Synflorix Group over Synflorix Group) is above (\>) 0.5.|Adjusted GMC ratio|0.52|||||TWO_SIDED|95.0|0.41|0.67||||||Demonstration of non-inferiority of Synflorix vaccine when co-administered with Nimenrix conjugate vaccine versus Synflorix vaccine given alone (Nimenrix conjugate vaccine was administered 1 month later) in terms of anti-pneumococcal serotype 18C antibody concentrations.||0.67|0.41|
72332656|NCT00758264|144189650|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit (LL) of the 95% confidence interval (CI) of the geometric mean concentration (GMC) ratio between the Nimenrix +Synflorix Group and the Synflorix Group (Nimenrix + Synflorix Group over Synflorix Group) is above (\>) 0.5.|Adjusted GMC ratio|0.86|||||TWO_SIDED|95.0|0.68|1.08||||||Demonstration of non-inferiority of Synflorix vaccine when co-administered with Nimenrix conjugate vaccine versus Synflorix vaccine given alone (Nimenrix conjugate vaccine was administered 1 month later) in terms of anti-pneumococcal serotype 19F antibody concentrations.||1.08|0.68|
72332657|NCT00758264|144189650|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit (LL) of the 95% confidence interval (CI) of the geometric mean concentration (GMC) ratio between the Nimenrix +Synflorix Group and the Synflorix Group (Nimenrix + Synflorix Group over Synflorix Group) is above (\>) 0.5.|Adjusted GMC ratio|1.07|||||TWO_SIDED|95.0|0.83|1.38||||||Demonstration of non-inferiority of Synflorix vaccine when co-administered with Nimenrix conjugate vaccine versus Synflorix vaccine given alone (Nimenrix conjugate vaccine was administered 1 month later) in terms of anti-pneumococcal serotype 23F antibody concentrations.||1.38|0.83|
72332658|NCT00758264|144189651|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit (LL) of the 2-sided standardized asymptotic 95% confidence interval (CI) for the group difference in percentage of subjects with serum bactericidal antibody using baby rabbit complement against Neisseria meningitides serogroup A (rSBA-MenA) titer ≥ 1:8 (Nimenrix + Synflorix Group minus Nimenrix Group) is ≥ -10%.|Difference in percentage|1.93|||||TWO_SIDED|95.0|-1.09|8.15||||||Demonstration of non-inferiority of Nimenrix conjugate vaccine when co-administered with Synflorix vaccine versus Nimenrix conjugate vaccine given alone (Synflorix vaccine was administered 1 month later) in terms of serum bactericidal assay using rabbit complement against Neisseria meningitides serogroup A (rSBA-MenA).||8.15|-1.09|
72332659|NCT00758264|144189651|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit (LL) of the 2-sided standardized asymptotic 95% confidence interval (CI) for the group difference in percentage of subjects with serum bactericidal antibody using baby rabbit complement against Neisseria meningitides serogroup C (rSBA-MenC) titer ≥ 1:8 (Nimenrix + Synflorix Group minus Nimenrix Group) is ≥ -10%.|Difference in percentage|0.68|||||TWO_SIDED|95.0|-2.11|6.22||||||Demonstration of non-inferiority of Nimenrix conjugate vaccine when co-administered with Synflorix vaccine versus Nimenrix conjugate vaccine given alone (Synflorix vaccine was administered 1 month later) in terms of serum bactericidal assay using rabbit complement against Neisseria meningitides serogroup C (rSBA-MenC).||6.22|-2.11|
72332660|NCT00758264|144189651|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit (LL) of the 2-sided standardized asymptotic 95% confidence interval (CI) for the group difference in percentage of subjects with serum bactericidal antibody using baby rabbit complement against Neisseria meningitides serogroup W-135 (rSBA-MenW-135) titer ≥ 1:8 (Nimenrix + Synflorix Group minus Nimenrix Group) is ≥ -10%.|Difference in percentage|1.25|||||TWO_SIDED|95.0|-0.94|6.76||||||Demonstration of non-inferiority of Nimenrix conjugate vaccine when co-administered with Synflorix vaccine versus Nimenrix conjugate vaccine given alone (Synflorix vaccine was administered 1 month later) in terms of serum bactericidal assay using rabbit complement against Neisseria meningitides serogroup W-135 (rSBA-MenW-135).||6.76|-0.94|
72332661|NCT00758264|144189651|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit (LL) of the 2-sided standardized asymptotic 95% confidence interval (CI) for the group difference in percentage of subjects with serum bactericidal antibody using baby rabbit complement against Neisseria meningitides serogroup Y (rSBA-MenY) titer ≥ 1:8 (Nimenrix + Synflorix Group minus Nimenrix Group) is ≥ -10%.|Difference in percentage|0.0|||||TWO_SIDED|95.0|-2.18|4.6||||||Demonstration of non-inferiority of Nimenrix conjugate vaccine when co-administered with Synflorix vaccine versus Nimenrix conjugate vaccine given alone (Synflorix vaccine was administered 1 month later) in terms of serum bactericidal assay using rabbit complement against Neisseria meningitides serogroup Y (rSBA-MenY).||4.6|-2.18|
72332662|NCT01467037|144189675|SUPERIORITY_OR_OTHER||Adjusted OR|0.088|||||TWO_SIDED|95.0|0.02|0.384|||||Conditional logistic regression was used. Adjusted VE = (1 - adjusted OR) \*100|||0.384|0.020|
72332663|NCT01467037|144189675|SUPERIORITY_OR_OTHER||Adjusted OR|0.075|||||TWO_SIDED|95.0|0.018|0.307|||||Conditional logistic regression was used. Adjusted VE = (1 - adjusted OR) \*100|||0.307|0.018|
72332664|NCT01194089|144189680|SUPERIORITY_OR_OTHER|||||||0.828|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Comparison between arms for the postoperative opioid use during the postanesthesia care unit (PACU) stay, using a one tailed P value.||||0.828
72332665|NCT01194089|144189680|SUPERIORITY_OR_OTHER|||||||0.752|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Comparison between the arms for the first 24 hours postoperatively, using a one tailed P value.||||0.752
72332666|NCT01194089|144189681|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED||||||Chi-squared|||Comparison between the arms for antiemetic medication use in the PACU.||||0.002
72332667|NCT01194089|144189682|SUPERIORITY_OR_OTHER|||||||0.354|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||The arms were compared for numeric pain score on admission.||||0.354
72332668|NCT01194089|144189682|SUPERIORITY_OR_OTHER|||||||0.492|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||The arms were compared for numeric pain score at 30 minutes.||||0.492
72332669|NCT01194089|144189682|SUPERIORITY_OR_OTHER|||||||0.809|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||The arms were compared for numeric pain score at 60 minutes.||||0.809
72332670|NCT01194089|144189682|SUPERIORITY_OR_OTHER|||||||0.381|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||The arms were compared for numeric pain score at discharge.||||0.381
72332671|NCT00939029|144189690|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.7||||0.05|TWO_SIDED|90.0|1.0|7.5||1 tailed p-value|Regression, Logistic|||||7.5|1.0|0.05
72423323|NCT01874145|144357464|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.058|STANDARD_ERROR_OF_MEAN|1.206||0.0897|TWO_SIDED|95.0|-4.438|0.322||The overall significance level for this study was 5% using 2-tailed test.|ANCOVA|In addition to treatment group, month (categorical), treatment-by-month interaction and score at baseline were used as covariates.|GA 40 mg/mL TIW treatment group vs. GA 20 mg/mL QD treatment group.|"To control for type 1 errors, secondary variables were analyzed only if analysis of the primary variable was statistically significant. Gate-keeping procedures offered further control with this hierarchy:~1. the rate of ISRs~2. change from baseline to month 4 (change - M4) in MSIS-20 physical wellbeing~3. change - M4 in MSIS-20 psychological wellbeing~4. change - M4 in TSQM-9 convenience~5. change - M4 in TSQM-9 overall satisfaction"||0.322|-4.438|0.0897
72423324|NCT00402337|144357480|SUPERIORITY_OR_OTHER|||||||0.0337||95.0|||||ANCOVA|||The null hypothesis is that the active treatment group is equal to the placebo group.||||0.0337
72423325|NCT00402337|144357480|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||ANCOVA|||The null hypothesis is that the active treatment group is equal to the placebo group.||||0.0010
72423326|NCT00402337|144357480|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||The null hypothesis is that the active treatment group is equal to the placebo group.||||<0.0001
72423327|NCT00402337|144357480|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||The null hypothesis is that the active treatment group is equal to the placebo group.||||<0.0001
72423328|NCT02821819|144357502|NON_INFERIORITY|The sample size was calculated assuming a non-inferiority margin of 5 eggs SD 6.7. A unilateral alpha level of 0.05 was stablished. With the aim to show that the difference in the mean number of collected eggs will not exceed 5, a statistical power of 80% required 30 patients per group (1:1 allocation, total sample: 60).|Mean Difference (Final Values)|18.0|STANDARD_DEVIATION|8.1||0.8|ONE_SIDED|||||a priori threshold for statistical significance: \<0.05|t-test, 1 sided|||The sample size was calculated assuming a non-inferiority margin of 5 eggs and a standard deviation (SD) of 6.7. A unilateral alpha level of 0.05 was stablished. With the aim to show that the difference in the mean number of collected eggs will not exceed 5, a statistical power of 80% required 30 patients per group (1:1 allocation, total sample: 60).|"Since the number of collected eggs constitutes the main outcome of the study, the sample size was calculated assuming a non-inferiority margin of 5 eggs with an standard deviation of 6.7. A unilateral alpha level of 0.05 was stablished. With the aim to show that the difference in the mean number of collected eggs will not exceed 5, a statistical power of 80% required 30 patients per group (1:1 allocation, total sample: 60).~Statistical analysis was performed using t-student test for continuous variables and chi-square test for categorical parameters. A P value of \<.05 was considered significant."|||0.8
72423329|NCT02821819|144357502|NON_INFERIORITY|The sample size was calculated assuming a non-inferiority margin of 5 eggs SD 6.7. A unilateral alpha level of 0.05 was stablished. With the aim to show that the difference in the mean number of collected eggs will not exceed 5, a statistical power of 80% required 30 patients per group (1:1 allocation, total sample: 60). Statistical analysis used t-student test for continuous variables and chi-square test for categorical parameters.|Mean Difference (Final Values)|82.0||||0.8|TWO_SIDED|||||a priori threshold for statistical significance: \<0.05|Chi-squared|||The sample size was calculated assuming a non-inferiority margin of 5 eggs SD 6.7. A unilateral alpha level of 0.05 was stablished. With the aim to show that the difference in the mean number of collected eggs will not exceed 5, a statistical power of 80% required 30 patients per group (1:1 allocation, total sample: 60). Statistical analysis used t-student test for continuous variables and chi-square test for categorical parameters.||||0.8
72423330|NCT02821819|144357503|NON_INFERIORITY|Statistical analysis was performed using t-student test for continuous variables and chi-square test for categorical parameters. A P value of \<.05 was considered significant.|Median Difference (Final Values)|71.1|||<|0.05|TWO_SIDED||||||Chi-squared|||||||<0.05
72423331|NCT00085202|144357513|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8001||95.0|||||Log Rank|||||||0.8001
72423332|NCT00085202|144357513|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5195||95.0|||||Log Rank|||||||0.5195
72423333|NCT00085202|144357513|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7696||95.0|||||Log Rank|||||||0.7696
72423334|NCT00085202|144357514|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0206||95.0|||||Log Rank|||||||0.0206
72423335|NCT00085202|144357516|SUPERIORITY|||||||0.6231|||||||t-test, 2 sided|||Change over time||||0.6231
72423336|NCT00085202|144357516|SUPERIORITY|||||||0.572|||||||t-test, 2 sided|||Baseline||||0.5720
72332672|NCT00939029|144189691|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.1||||0.014|TWO_SIDED|90.0|1.4|11.6||1 tailed|Regression, Logistic|||||11.6|1.4|0.014
72423337|NCT00658138|144357527|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|No power calculation done - pilot study|Mean Difference (Final Values)|0.05||||0.05|||||||Wilcoxon (Mann-Whitney)|||Hypothesis was no difference between adhesives tested at one year. Restorations were scored using USPHS subjective clinical criteria.||||0.05
72423338|NCT00658138|144357527|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|No power calculation done - pilot study|percentage of Alpha values||||>|0.05||95.0|||||Wilcoxon (Mann-Whitney)|||Null hypothesis is adhesives are not different in clinical performance at one year||||>0.05
72423339|NCT02081950|144357528|OTHER|Results were obtained using a mixed-effects ANOVA with fixed effect of study period and a random effect for subject.|Geometric least square mean ratio|93.65|||||TWO_SIDED|90.0|87.56|100.16||||||||100.16|87.56|
72423340|NCT02081950|144357529|OTHER|Results were obtained using a mixed-effects ANOVA with fixed effect of study period and a random effect for subject.|Geometric least square mean ratio|100.46|||||TWO_SIDED|90.0|95.74|105.42||||||||105.42|95.74|
72423341|NCT02081950|144357530|OTHER|Results were obtained using a mixed-effects ANOVA with fixed effect of study period and a random effect for subject.|Geometric least square mean ratio|101.16|||||TWO_SIDED|90.0|96.32|106.24||||||||106.24|96.32|
72423342|NCT02081950|144357531|OTHER|Results were obtained using a mixed-effects ANOVA with fixed effect of study period and a random effect for subject.|Geometric least square mean ratio|94.88|||||TWO_SIDED|90.0|88.49|101.73||||||||101.73|88.49|
72423343|NCT02081950|144357532|OTHER|Results were obtained using a mixed-effects ANOVA with fixed effect of study period and a random effect for subject.|Geometric least square mean ratio|97.13|||||TWO_SIDED|90.0|89.93|104.91||||||||104.91|89.93|
72332673|NCT00939029|144189692|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.2||||0.087|TWO_SIDED|90.0|0.8|6.0||1 tailed|Regression, Logistic|||||6.0|0.8|0.087
72332674|NCT01106651|144189721|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-0.57|STANDARD_ERROR_OF_MEAN|0.069|<|0.001|TWO_SIDED|95.0|-0.708|-0.436|||ANCOVA|||||-0.436|-0.708|<0.001
72332675|NCT01106651|144189721|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|95.0|-0.841|-0.566|||ANCOVA|||||-0.566|-0.841|<0.001
72332676|NCT01106651|144189722|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.96|||<|0.001||95.0|1.93|4.56|||Regression, Logistic|||||4.56|1.93|<0.001
72332677|NCT01106651|144189722|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.48|||<|0.001||95.0|2.89|6.95|||Regression, Logistic|||||6.95|2.89|<0.001
72332678|NCT01106651|144189723|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-25.5|STANDARD_ERROR_OF_MEAN|3.147|<|0.001|TWO_SIDED|95.0|-31.68|-19.32|||ANCOVA|||||-19.32|-31.68|<0.001
72423344|NCT02081950|144357533|OTHER|Results were obtained using a mixed-effects ANOVA with fixed effect of study period and a random effect for subject.|Geometric least square mean ratio|108.84|||||TWO_SIDED|90.0|95.61|123.91||||||||123.91|95.61|
72423345|NCT02081950|144357544|OTHER|Results were obtained using a mixed-effects ANOVA with fixed effect of study period and a random effect for subject.|Geometric least square mean ratio|102.45|||||TWO_SIDED|90.0|96.31|109.0||||||||109.0|96.31|
72332679|NCT01106651|144189723|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-27.7|STANDARD_ERROR_OF_MEAN|3.179|<|0.001|TWO_SIDED|95.0|-33.97|-21.49|||ANCOVA|||||-21.49|-33.97|<0.001
72332680|NCT01106651|144189724|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-2.3|STANDARD_ERROR_OF_MEAN|0.3|<|0.001|TWO_SIDED|95.0|-2.8|-1.7|||ANCOVA|||||-1.7|-2.8|<0.001
72332681|NCT01106651|144189724|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-3.0|STANDARD_ERROR_OF_MEAN|0.3|<|0.001|TWO_SIDED|95.0|-3.5|-2.4|||ANCOVA|||||-2.4|-3.5|<0.001
72423346|NCT02081950|144357545|OTHER|Results were obtained using a mixed-effects ANOVA with fixed effect of study period and a random effect for subject.|geometric least square mean ratio|95.84|||||TWO_SIDED|90.0|79.11|116.11||||||||116.11|79.11|
72332682|NCT01106651|144189725|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-1.59|STANDARD_ERROR_OF_MEAN|0.379|<|0.001|TWO_SIDED|95.0|-2.339|-0.842|||ANCOVA|||||-0.842|-2.339|<0.001
72423347|NCT02081950|144357547|OTHER|Results were obtained using a mixed-effects ANOVA with fixed effect of study period and a random effect for subject.|geometric least square mean ratio|99.54|||||TWO_SIDED|90.0|95.69|103.54||||||||103.54|95.69|
72423348|NCT02081950|144357551|OTHER|Results were obtained using a mixed-effects ANOVA with fixed effect of study period and a random effect for subject.|geometric least square mean ratio|98.36|||||TWO_SIDED|90.0|95.31|101.51||||||||101.51|95.31|
72423349|NCT02081950|144357552|OTHER|Results were obtained using a mixed-effects ANOVA with fixed effect of study period and a random effect for subject|geometric least square mean ratio|111.3|||||TWO_SIDED|90.0|99.73|124.2||||||||124.2|99.73|
72332683|NCT01106651|144189725|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-2.1|STANDARD_ERROR_OF_MEAN|0.371|<|0.001|TWO_SIDED|95.0|-2.833|-1.368|||ANCOVA|||||-1.368|-2.833|<0.001
72332684|NCT01106651|144189726|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-1.03|STANDARD_ERROR_OF_MEAN|0.305|<|0.001|TWO_SIDED|95.0|-1.633|-0.428|||ANCOVA|||Region percent total fat||-0.428|-1.633|<0.001
72423350|NCT02081950|144357555|OTHER|Results were obtained using a mixed-effects ANOVA with fixed effect of study period and a random effect for subject|geometric least square mean ratio|98.7|||||TWO_SIDED|90.0|93.16|104.57||||||||104.57|93.16|
72332685|NCT01106651|144189726|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-1.18|STANDARD_ERROR_OF_MEAN|0.3|<|0.001|TWO_SIDED|95.0|-1.772|-0.587|||ANCOVA|||Region percent total fat||-0.587|-1.772|<0.001
72332686|NCT01106651|144189727|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-1.05|STANDARD_ERROR_OF_MEAN|0.316||0.001|TWO_SIDED|95.0|-1.677|-0.43|||ANCOVA|||||-0.430|-1.677|0.001
72332687|NCT01106651|144189727|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|0.311|<|0.001|TWO_SIDED|95.0|-1.812|-0.584|||ANCOVA|||||-0.584|-1.812|<0.001
72332688|NCT01106651|144189728|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-4.63|STANDARD_ERROR_OF_MEAN|1.134|<|0.001|TWO_SIDED|95.0|-6.854|-2.401|||ANCOVA|||||-2.401|-6.854|<0.001
72332689|NCT01106651|144189728|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-7.89|STANDARD_ERROR_OF_MEAN|1.147|<|0.001|TWO_SIDED|95.0|-10.14|-5.641|||ANCOVA|||||-5.641|-10.14|<0.001
72332690|NCT01106651|144189729|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-4.8|STANDARD_ERROR_OF_MEAN|3.7||0.194|TWO_SIDED|95.0|-12.1|2.5|||ANCOVA|||||2.5|-12.1|0.194
72423351|NCT02081950|144357556|OTHER||geometric least square mean ratio|103.43|||||TWO_SIDED|90.0|94.5|113.2||||||||113.2|94.5|
72423352|NCT02081950|144357557|OTHER||geometric least square mean ratio|92.92|||||TWO_SIDED|90.0|80.58|107.16||||||||107.16|80.58|
72423353|NCT00110890|144357569|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|8.74|||<|0.001||95.0|5.72|13.36|||Cochran-Mantel-Haenszel|Adjusted for four baseline strata defined by vitamin D prescribed and calcium x phosphorus ≤ 55 mg\^2/dL\^2|Adjusted for four baseline strata defined by vitamin D prescribed and calcium x phosphorus ≤ 55 mg\^2/dL\^2|||13.36|5.72|<0.001
72332691|NCT01106651|144189729|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|0.7|STANDARD_ERROR_OF_MEAN|3.7||0.846|TWO_SIDED|95.0|-6.6|8.1|||ANCOVA|||||8.1|-6.6|0.846
72332692|NCT01106651|144189730|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|5.3|STANDARD_ERROR_OF_MEAN|1.4|<|0.001|TWO_SIDED|95.0|2.6|7.9|||ANCOVA|||||7.9|2.6|<0.001
72332693|NCT01106651|144189730|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|4.7|STANDARD_ERROR_OF_MEAN|1.4|<|0.001|TWO_SIDED|95.0|2.0|7.4|||ANCOVA|||||7.4|2.0|<0.001
72332694|NCT01106651|144189731|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|0.3|||TWO_SIDED|95.0|-0.4|0.8|||ANCOVA|||||0.8|-0.4|
72332695|NCT01106651|144189731|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.3|||TWO_SIDED|95.0|-0.9|0.3|||ANCOVA|||||0.3|-0.9|
72332696|NCT01106651|144189732|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.3|||TWO_SIDED|95.0|-0.9|0.4|||ANCOVA|||||0.4|-0.9|
72332697|NCT01106651|144189732|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.3|||TWO_SIDED|95.0|-1.0|0.3|||ANCOVA|||||0.3|-1.0|
72332698|NCT01106651|144189733|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|0.3|||TWO_SIDED|95.0|-0.3|1.0|||ANCOVA|||||1.0|-0.3|
72332699|NCT01106651|144189733|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|0.4|STANDARD_ERROR_OF_MEAN|0.3|||TWO_SIDED|95.0|-0.3|1.1|||ANCOVA|||||1.1|-0.3|
72332700|NCT01106651|144189734|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.2|||TWO_SIDED|95.0|-0.8|0.0|||ANCOVA|||||-0.0|-0.8|
72332701|NCT01106651|144189734|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.2|||TWO_SIDED|95.0|-0.9|-0.1|||ANCOVA|||||-0.1|-0.9|
72332702|NCT03641716|144189783|OTHER||Mean Difference (Net)|3.67|STANDARD_DEVIATION|2.08|||TWO_SIDED|||||||||||||
72423354|NCT00110890|144357570|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|8.74|||<|0.001||95.0|5.38|14.19|||Cochran-Mantel-Haenszel|Adjusted for four baseline strata defined by vitamin D prescribed and calcium x phosphorus ≤ 55 mg\^2/dL\^2|Adjusted for four baseline strata defined by vitamin D prescribed and calcium x phosphorus ≤ 55 mg\^2/dL\^2|||14.19|5.38|<0.001
72423355|NCT00110890|144357571|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.11|||<|0.001||95.0|2.0|4.84|||Cochran-Mantel-Haenszel|Adjusted for four baseline strata defined by vitamin D prescribed and calcium x phosphorus ≤ 55 mg\^2/dL\^2|Adjusted for four baseline strata defined by vitamin D prescribed and calcium x phosphorus ≤ 55 mg\^2/dL\^2|||4.84|2.00|<0.001
72423356|NCT00110890|144357572|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.93|||<|0.001||95.0|4.65|10.34|||Cochran-Mantel-Haenszel|Adjusted for four baseline strata defined by vitamin D prescribed and calcium x phosphorus ≤ 55 mg\^2/dL\^2|Adjusted for four baseline strata defined by vitamin D prescribed and calcium x phosphorus ≤ 55 mg\^2/dL\^2|||10.34|4.65|<0.001
72423357|NCT00110890|144357573|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.88||||0.002||95.0|1.26|2.81|||Cochran-Mantel-Haenszel|Adjusted for four baseline strata defined by vitamin D prescribed and calcium x phosphorus ≤ 55 mg\^2/dL\^2|Adjusted for four baseline strata defined by vitamin D prescribed and calcium x phosphorus ≤ 55 mg\^2/dL\^2|||2.81|1.26|0.002
72423358|NCT01960530|144357629|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|To investigate the absolute and relative bioavailability of cortisol from oral Infacort®, a 20 mg dose of oral Infacort® was compared to a 20 mg dose of i.v. hydrocortisone and hydrocortisone tablets, respectively (Study Periods 3-5). These investigations were conducted in dexamethasone suppressed healthy subjects. Standard bioavailability limits of 80% to 125% were used.|Geometric LSmean ratio|60.12|||||TWO_SIDED|90.0|54.69|66.1||||||Evaluation of Cmax||66.10|54.69|
72423359|NCT01960530|144357629|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|To investigate the absolute and relative bioavailability of cortisol from oral Infacort®, a 20 mg dose of oral Infacort® was compared to a 20 mg dose of i.v. hydrocortisone and hydrocortisone tablets, respectively (Study Periods 3-5). These investigations were conducted in dexamethasone suppressed healthy subjects. Standard bioavailability limits of 80% to 125% were used.|Geometric LSmean ratio|106.83|||||TWO_SIDED|90.0|96.92|117.76||||||||117.76|96.92|
72423360|NCT01960530|144357634|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|86.99|||||TWO_SIDED|90.0|79.23|95.52||||||||95.52|79.23|
72423361|NCT01960530|144357634|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|89.96|||||TWO_SIDED|90.0|81.72|99.04||||||||99.04|81.72|
72423362|NCT01301274|144357635|NON_INFERIORITY_OR_EQUIVALENCE|beta error 20%, alfa error 5%, diminished 2 mEq/L between groups||||||0.04||95.0|||||t-test, 2 sided|||||||0.04
72423363|NCT01301274|144357636|SUPERIORITY_OR_OTHER|||||||0.081||95.0||||without adjust|Chi-squared|||||||0.081
72423364|NCT01301274|144357637|SUPERIORITY_OR_OTHER|||||||0.396||95.0|||||t-test, 2 sided|||||||0.396
72423365|NCT01301274|144357638|SUPERIORITY_OR_OTHER|||||||0.129||95.0|||||t-test, 2 sided|||||||0.129
72423366|NCT04512066|144357639|OTHER||treatment effect|0.6||||0.849|TWO_SIDED|90.0|-4.58|5.78|||Mixed Models Analysis|||||5.78|-4.58|0.849
72423367|NCT04512066|144357639|OTHER||treatment effect|-2.83||||0.362|TWO_SIDED|90.0|-7.96|2.29|||Mixed Models Analysis|||||2.29|-7.96|0.362
72423368|NCT04512066|144357639|OTHER||treatment effect|-10.45||||0.001|TWO_SIDED|90.0|-15.46|-5.43|||Mixed Models Analysis|||||-5.43|-15.46|0.001
72423369|NCT00445679|144357654|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority to paroxetine was declared if the lower limit of the 95% two-sided confidence interval for the difference in responders is greater than or equal to -9 percentage points.|Difference|-3.13|||||TWO_SIDED|95.0|-12.62|6.37||||||||6.37|-12.62|
72423370|NCT00445679|144357654|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority to paroxetine was declared if the lower limit of the 95% two-sided confidence interval for the difference in responders is greater than or equal to -9 percentage points.|Difference|0.88|||||TWO_SIDED|95.0|-8.5|10.25||||||||10.25|-8.50|
72423371|NCT00445679|144357654|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority to paroxetine was declared if the lower limit of the 95% two-sided confidence interval for the difference in responders is greater than or equal to -9 percentage points.|Difference|-2.17|||||TWO_SIDED|95.0|-11.68|7.33||||||||7.33|-11.68|
72423372|NCT00445679|144357655|SUPERIORITY_OR_OTHER|||||||0.714||95.0|||||Cochran-Mantel-Haenszel|||Final on-therapy population||||0.714
72423373|NCT00445679|144357655|SUPERIORITY_OR_OTHER|||||||0.653||95.0|||||Cochran-Mantel-Haenszel|||Final on-therapy population||||0.653
72423374|NCT00445679|144357655|SUPERIORITY_OR_OTHER|||||||0.881||95.0|||||Cochran-Mantel-Haenszel|||Final on-therapy population||||0.881
72423375|NCT00445679|144357656|SUPERIORITY_OR_OTHER|||||||0.45||95.0|||||Cochran-Mantel-Haenszel|||Final on-therapy population||||0.450
72423376|NCT00445679|144357656|SUPERIORITY_OR_OTHER|||||||0.452||95.0|||||Cochran-Mantel-Haenszel|||Final on-therapy population||||0.452
72423377|NCT00445679|144357656|SUPERIORITY_OR_OTHER|||||||0.85||95.0|||||Cochran-Mantel-Haenszel|||Final on-therapy population||||0.850
72423378|NCT03857230|144357661|EQUIVALENCE|The 90% CIs of the ratios of geometric means of log-transformed baseline AUC0-192 were used to assess bioequivalence between Primapur and Gonal-F (bioequivalence range of 80.00% to 125.00%)|Geometric Mean Ratio (%)|93.31||||0.05|TWO_SIDED|90.0|87.25|99.79|||ANOVA|||Statistical comparison of the obtained results comprised the calculation of parametric bilateral 90 % CIs for the ratios of the corresponding mean values of the pharmacokinetic parameters of the study and comparator drug. The equivalence of the pharmacokinetics of the drug products will be proven if the limits of the evaluated CIs for the ratios of the mean values are in the range of 80.00-125.00%.||99.79|87.25|0.05
72332703|NCT03641716|144189784|OTHER||Effect Size - Cohen's d|-0.01|||||TWO_SIDED|95.0|-0.66|0.65||||||Due to limited size of sub-sample, we calculated a Cohen's d effect size for raw total score on the PSI from baseline to the 3-month follow-up, with a 95% confidence interval.||.65|-.66|
72423379|NCT03857230|144357662|EQUIVALENCE|The 90% CIs of the ratios of geometric means of log-transformed baseline Cmax were used to assess bioequivalence between Primapur and Gonal-F (bioequivalence range of 80.00% to 125.00%)|Geometric Mean Ratio (%)|87.93||||0.05|TWO_SIDED|90.0|82.85|93.33|||ANOVA|||||93.33|82.85|0.05
72423380|NCT03535337|144357679|SUPERIORITY||Slope|2.44|STANDARD_ERROR_OF_MEAN|1.1||0.03|TWO_SIDED|95.0|0.28|4.59|||Mixed Models Analysis|||||4.59|0.28|0.03
72423381|NCT03535337|144357680|SUPERIORITY||Slope|0.17|STANDARD_ERROR_OF_MEAN|0.76||0.82|TWO_SIDED|95.0|-1.32|1.66|||Mixed Models Analysis|||||1.66|-1.32|0.82
72423382|NCT01480596|144357712|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.84|STANDARD_ERROR_OF_MEAN|1.592||0.256|TWO_SIDED|95.0|-5.08|1.4|||Mixed Models Analysis||Standard error of mean is for adjusted difference.|||1.40|-5.08|0.256
72423383|NCT01480596|144357713|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.81||||0.082||95.0|0.87|19.02|||exact methods|||||19.02|0.87|0.082
72423384|NCT01480596|144357714|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.55||||0.827||95.0|0.05|4.35|||exact methods|||||4.35|0.05|0.827
72423385|NCT01480596|144357715|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.51||||0.184|TWO_SIDED|95.0|0.62|10.1|||Cochran-Mantel-Haenszel|||||10.10|0.62|0.184
72423386|NCT01480596|144357717|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.7|STANDARD_ERROR_OF_MEAN|1.228||0.175|TWO_SIDED|95.0|-4.2|0.8|||Mixed Models Analysis||Analysis for Week 28. Standard error of mean is for adjusted difference.|||0.80|-4.20|0.175
72423387|NCT01480596|144357717|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-1.31|STANDARD_ERROR_OF_MEAN|1.267||0.31|TWO_SIDED|95.0|-3.89|1.28|||Mixed Models Analysis||Analysis for Week 32. Standard error of mean is for adjusted difference.|||1.28|-3.89|0.310
72423388|NCT01480596|144357717|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-2.29|STANDARD_ERROR_OF_MEAN|1.272||0.081|TWO_SIDED|95.0|-4.88|0.3|||Mixed Models Analysis||Analysis for Week 36. Standard error of mean is for adjusted difference.|||0.30|-4.88|0.081
72423389|NCT01480596|144357718|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|1.486||0.972|TWO_SIDED|95.0|-2.97|3.07|||Mixed Models Analysis||Standard error of mean is for adjusted difference.|||3.07|-2.97|0.972
72423390|NCT01480596|144357719|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.17||||1|TWO_SIDED|95.0|0.26|5.48|||exact methods|||||5.48|0.26|1.000
72423391|NCT01480596|144357720|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.4||||0.53|TWO_SIDED|95.0|0.03|2.89|||exact methods|||||2.89|0.03|0.530
72423392|NCT01480596|144357721|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.7||||0.175|TWO_SIDED|95.0|0.64|11.46|||Cochran-Mantel-Haenszel|||||11.46|0.64|0.175
72423393|NCT01480596|144357723|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.01|STANDARD_ERROR_OF_MEAN|1.245||0.423|TWO_SIDED|95.0|-3.56|1.53|||Mixed Models Analysis||Analysis for Week 28. Standard error of mean is for adjusted difference.|||1.53|-3.56|0.423
72423394|NCT01480596|144357723|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|1.361||0.986|TWO_SIDED|95.0|-2.76|2.8|||Mixed Models Analysis||Analysis for Week 32. Standard error of mean is for adjusted difference.|||2.80|-2.76|0.986
72423395|NCT01480596|144357723|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.28|STANDARD_ERROR_OF_MEAN|1.43||0.848|TWO_SIDED|95.0|-3.21|2.65|||Mixed Models Analysis||Analysis for Week 36. Standard error of mean is for adjusted difference.|||2.65|-3.21|0.848
72423396|NCT01480596|144357729|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|0.707||0.483|TWO_SIDED|95.0|-1.94|0.93|||Mixed Models Analysis||Statistical analysis is presented for Week 12. Standard error of mean is for adjusted mean difference.|||0.93|-1.94|0.483
72423397|NCT01480596|144357729|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.31|STANDARD_ERROR_OF_MEAN|0.844||0.711|TWO_SIDED|95.0|-2.03|1.4|||Mixed Models Analysis||Statistical analysis is presented for Week 24. Standard error of mean is for adjusted mean difference.|||1.40|-2.03|0.711
72423398|NCT01480596|144357730|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.75|STANDARD_ERROR_OF_MEAN|0.757||0.028|TWO_SIDED|95.0|-3.3|-0.2|||Mixed Models Analysis||Analysis for Week 28. Standard error of mean is for adjusted difference.|||-0.20|-3.30|0.028
72423399|NCT01480596|144357730|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.28|STANDARD_ERROR_OF_MEAN|0.887||0.756|TWO_SIDED|95.0|-2.1|1.55|||Mixed Models Analysis||Analysis for Week 32. Standard error of mean is for adjusted difference.|||1.55|-2.10|0.756
72423400|NCT01480596|144357730|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.26|STANDARD_ERROR_OF_MEAN|0.909||0.775|TWO_SIDED|95.0|-2.12|1.59|||Mixed Models Analysis||Analysis for Week 36. Standard error of mean is for adjusted difference.|||1.59|-2.12|0.775
72423401|NCT04503096|144357732|OTHER|To monitor safety, paired t-tests were conducted to test for pre- to post-treatment differences in global cognition (i.e., MoCA z-scores).||||||0.725|||||||t-test, 2 sided|||||||0.725
72423402|NCT04503096|144357736|OTHER|Paired t-tests were conducted to test for pre- to post-treatment changes in depression using HAM-D raw scores.||||||0.605|||||||t-test, 2 sided|||||||.605
72423403|NCT04503096|144357737|OTHER|Paired t-tests were conducted to test for pre- to post-treatment changes in depression using GDS raw scores.||||||0.897|||||||t-test, 2 sided|||||||.897
72423404|NCT04503096|144357738|OTHER|Paired t-tests were conducted to test for pre- to post-treatment changes in cognition using Fluid Cognition Composite Scores.|||||<|0.001|||||||t-test, 2 sided|||||||< .001
72423405|NCT01453348|144357763|NON_INFERIORITY_OR_EQUIVALENCE|(GMC anti-HAV + MenACWY-CRM / GMC anti-HAV)|Ratio of GMC|0.89|||||TWO_SIDED|95.0|0.6|1.32||The testing was done by assessing the confidence interval of the ratio|ANCOVA|The Analysis of variance (ANCOVA) model included vaccine group and center as factors, age as covariate and was adjusted for baseline.||The primary criterion for immunogenicity was that the lower-limit of the two-sided 95% Confidence Interval (CI) on the ratio of Enzyme-linked Immunosorbent Assay (ELISA) GMCs (Hep A/B + MenACWY-CRM to Hep A/B) is below or equal to 0.5.||1.32|0.6|
72423406|NCT01453348|144357763|NON_INFERIORITY_OR_EQUIVALENCE|(GMC anti-HBsAg + MenACWY-CRM / GMC anti-HBsAg)|Ratio of GMC|1.19|||||TWO_SIDED|95.0|0.59|2.37||The testing was done by assessing the confidence interval of the ratio|ANCOVA|The ANCOVA model included vaccines group and center as factors, age as covariate and was adjusted for baseline.||The primary criterion for immunogenicity was that the the lower-limit of the two-sided 95% CI on the ratio of ELISA GMCs (Hep A/B + MenACWY-CRM to Hep A/B) is below or equal to 0.5.||2.37|0.59|
72423407|NCT03592277|144357779|SUPERIORITY|||||||0.344|||||||Chi-squared|||||||0.344
72423408|NCT03592277|144357780|SUPERIORITY|||||||0.526|||||||Chi-squared|||||||0.526
72423409|NCT03592277|144357781|SUPERIORITY|||||||0.123|||||||Chi-squared|||||||0.123
72423410|NCT03592277|144357782|SUPERIORITY|||||||0.66|||||||Fisher Exact|||||||0.660
72423411|NCT03592277|144357783|SUPERIORITY|||||||0.745|||||||t-test, 2 sided|||||||0.745
72423412|NCT03592277|144357784|SUPERIORITY|||||||0.236|||||||Chi-squared|||||||0.236
72423413|NCT01462162|144357794|SUPERIORITY_OR_OTHER|||||||0.006|||||||Regression, Linear|||change in fatigue score versus change in DAS-28 score||||0.006
72423414|NCT01462162|144357794|SUPERIORITY_OR_OTHER|||||||0|||||||Regression, Linear|||change in fatigue score versus change in sleepiness score||||0.000
72423415|NCT01462162|144357794|SUPERIORITY_OR_OTHER|||||||0|||||||Regression, Linear|||change in fatigue score versus change in depression score||||0.000
72423416|NCT01462162|144357795|SUPERIORITY_OR_OTHER|||||||0.023|||||||Regression, Linear|||change in fatigue score versus change in DAS-28 score||||0.023
72423417|NCT01462162|144357795|SUPERIORITY_OR_OTHER|||||||0.007|||||||Regression, Linear|||change in fatigue score versus change in sleepiness score||||0.007
72423418|NCT01462162|144357795|SUPERIORITY_OR_OTHER|||||||0|||||||Regression, Linear|||change in fatigue score versus change in depression score||||0.000
72423419|NCT01462162|144357796|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||Baseline versus Week 12||||<0.001
72423420|NCT01462162|144357796|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||Baseline versus Week 24||||<0.001
72423421|NCT01462162|144357797|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||Baseline for Week 12 versus Week 12||||<0.001
72423422|NCT01462162|144357797|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||Baseline for Week 24 versus Week 24||||<0.001
72423423|NCT01462162|144357798|SUPERIORITY_OR_OTHER|||||||0.003|||||||Regression, Linear|||change in fatigue score at Week 12 versus change in DAS-28 at Week 12||||0.003
72423424|NCT01462162|144357798|SUPERIORITY_OR_OTHER|||||||0.006|||||||Regression, Linear|||change in fatigue score at Week 24 versus change in DAS-28 at Week 24||||0.006
72423425|NCT01462162|144357798|SUPERIORITY_OR_OTHER|||||||0.791|||||||Regression, Linear|||change in fatigue score at Week 12 versus change in serum hemoglobin Week 12||||0.791
72423426|NCT01462162|144357798|SUPERIORITY_OR_OTHER|||||||0.847|||||||Regression, Linear|||change in fatigue score at Week 24 versus change in serum hemoglobin Week 24||||0.847
72423427|NCT01462162|144357798|SUPERIORITY_OR_OTHER|||||||0.182|||||||Regression, Linear|||change in fatigue score at Week 12 versus change in swollen joint count Week 12||||0.182
72423428|NCT01462162|144357798|SUPERIORITY_OR_OTHER|||||||0.022|||||||Regression, Linear|||change in fatigue score at Week 24 versus change in swollen joint count Week 24||||0.022
72423429|NCT01462162|144357798|SUPERIORITY_OR_OTHER|||||||0.163|||||||Regression, Linear|||change in fatigue score at Week 12 versus change in morning stiffness Week 12||||0.163
72423430|NCT01462162|144357798|SUPERIORITY_OR_OTHER|||||||0.115|||||||Regression, Linear|||change in fatigue score at Week 24 versus change in morning stiffness Week 24||||0.115
72423431|NCT01462162|144357798|SUPERIORITY_OR_OTHER|||||||0.037|||||||Regression, Linear|||change in fatigue score at Week 12 versus change in degree of pain Week 12||||0.037
72423432|NCT01462162|144357798|SUPERIORITY_OR_OTHER|||||||0.044|||||||Regression, Linear|||change in fatigue score at Week 24 versus change in degree of pain Week 24||||0.044
72423433|NCT01462162|144357798|SUPERIORITY_OR_OTHER|||||||0.003|||||||Regression, Linear|||change in fatigue score at Week 12 versus change in sleepiness at Week 12||||0.003
72423434|NCT01462162|144357798|SUPERIORITY_OR_OTHER|||||||0.001|||||||Regression, Linear|||change in fatigue score at Week 24 versus change in sleepiness at Week 24||||0.001
72423435|NCT01462162|144357798|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Regression, Linear|||change in fatigue score at Week 12 versus change in depression Week 12||||<0.001
72423436|NCT01462162|144357798|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Regression, Linear|||change in fatigue score at Week 24 versus change in depression at Week 24||||<0.001
72423437|NCT01462162|144357799|SUPERIORITY_OR_OTHER|||||||0.678|||||||Regression, Linear|||change in hemoglobin levels versus change in swollen joint count (Week 12)||||0.678
72423438|NCT01462162|144357799|SUPERIORITY_OR_OTHER|||||||0.348|||||||Regression, Linear|||change in hemoglobin levels versus change in swollen joint count (Week 24)||||0.348
72423439|NCT01462162|144357799|SUPERIORITY_OR_OTHER|||||||0.679|||||||Regression, Linear|||change in hemoglobin levels versus change in morning stiffness (Week 12)||||0.679
72423440|NCT01462162|144357799|SUPERIORITY_OR_OTHER|||||||0.556|||||||Regression, Linear|||change in hemoglobin levels versus change in morning stiffness (Week 24)||||0.556
72423441|NCT01462162|144357799|SUPERIORITY_OR_OTHER|||||||0.692|||||||Regression, Linear|||change in haemoglobin levels versus change in degree of pain (Week 12)||||0.692
72423442|NCT01462162|144357799|SUPERIORITY_OR_OTHER|||||||0.771|||||||Regression, Linear|||change in haemoglobin levels versus change in degree of pain (Week 24)||||0.771
72423443|NCT01462162|144357799|SUPERIORITY_OR_OTHER|||||||0.878|||||||Regression, Linear|||change in haemoglobin levels versus change in sleepiness (Week 12)||||0.878
72423444|NCT01462162|144357799|SUPERIORITY_OR_OTHER|||||||0.139|||||||Regression, Linear|||change in haemoglobin levels versus change in sleepiness (Week 24)||||0.139
72423445|NCT01462162|144357799|SUPERIORITY_OR_OTHER|||||||0.249|||||||Regression, Linear|||change in haemoglobin levels versus change in depression score (Week 12)||||0.249
72423446|NCT01462162|144357799|SUPERIORITY_OR_OTHER|||||||0.61|||||||Regression, Linear|||change in hemoglobin levels versus change in depression score (Week 24)||||0.610
72423447|NCT01462162|144357800|SUPERIORITY_OR_OTHER|||||||0.257|||||||Regression, Linear|||change in haemoglobin levels versus change in swollen joint count (Week 12)||||0.257
72423448|NCT01462162|144357800|SUPERIORITY_OR_OTHER|||||||0.487|||||||Regression, Linear|||change in haemoglobin levels versus change in swollen joint count (Week 24)||||0.487
72423449|NCT01462162|144357800|SUPERIORITY_OR_OTHER|||||||0.644|||||||Regression, Linear|||change in hemoglobin levels versus change in morning stiffness (Week 12)||||0.644
72423450|NCT01462162|144357800|SUPERIORITY_OR_OTHER|||||||0.498|||||||Regression, Linear|||change in hemoglobin levels versus change in morning stiffness (Week 24)||||0.498
72423451|NCT01462162|144357800|SUPERIORITY_OR_OTHER|||||||0.65|||||||Regression, Linear|||change in hemoglobin levels versus change in degree of pain (Week 12)||||0.650
72423452|NCT01462162|144357800|SUPERIORITY_OR_OTHER|||||||0.75|||||||Regression, Cox|||change in hemoglobin levels versus change in degree of pain (Week 24)||||0.750
72423453|NCT01462162|144357800|SUPERIORITY_OR_OTHER|||||||0.936|||||||Regression, Linear|||change in hemoglobin levels versus change in sleepiness (Week 12)||||0.936
72423454|NCT01462162|144357800|SUPERIORITY_OR_OTHER|||||||0.075|||||||Regression, Linear|||change in hemoglobin levels versus change in sleepiness (Week 24)||||0.075
72423455|NCT01462162|144357800|SUPERIORITY_OR_OTHER|||||||0.098|||||||Regression, Linear|||change in hemoglobin levels versus change in depression score (Week 12)||||0.098
72423456|NCT01462162|144357800|SUPERIORITY_OR_OTHER|||||||0.09|||||||Regression, Linear|||change in hemoglobin levels versus change in depression score (Week 24)||||0.090
72423457|NCT01462162|144357801|SUPERIORITY_OR_OTHER|||||||0.077|||||||Multiple Regression|||change in hemoglobin levels versus change in swollen joint count (Week 12)||||0.077
72423458|NCT01462162|144357801|SUPERIORITY_OR_OTHER|||||||0.961|||||||Multiple Regression|||change in hemoglobin levels versus change in swollen joint count (Week 24)||||0.961
72423459|NCT01462162|144357802|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||Baseline for Week 12 versus Week 12||||<0.001
72423460|NCT01462162|144357802|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||Baseline for Week 24 versus Week 24||||<0.001
72423461|NCT01462162|144357803|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||Baseline for Week 12 versus Week 12||||<0.001
72423462|NCT01462162|144357803|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||Baseline for Week 24 versus Week 24||||<0.001
72423463|NCT01462162|144357804|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||Baseline for Week 12 versus Week 12||||<0.001
72423464|NCT01462162|144357804|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||Baseline for Week 24 versus Week 24||||<0.001
72423465|NCT01462162|144357805|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||Baseline for Week 12 versus Week 12||||<0.001
72423466|NCT01462162|144357805|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||Baseline for Week 24 versus Week 24||||<0.001
72423467|NCT01462162|144357806|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||Baseline for Week 12 versus Week 12||||<0.001
72423468|NCT01462162|144357806|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||Baseline for Week 24 versus Week 24||||<0.001
72423469|NCT01462162|144357807|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||Baseline for Week 12 versus Week 12||||<0.001
72423470|NCT01462162|144357807|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||Baseline for Week 24 versus Week 24||||<0.001
72423471|NCT01462162|144357808|SUPERIORITY_OR_OTHER|||||||0.172|||||||t-test, 2 sided|||Baseline for Week 12 versus Week 12||||0.172
72423472|NCT01462162|144357808|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Regression, Logistic|||Baseline for Week 24 versus Week 24||||<0.05
72423473|NCT01462162|144357809|SUPERIORITY_OR_OTHER|||||||0.162|||||||t-test, 2 sided|||Baseline for Week 12 versus Week 12||||0.162
72423474|NCT01462162|144357809|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||Baseline for Week 12 versus Week 24||||<0.001
72423475|NCT01462162|144357810|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||Baseline for Week 12 versus Week 12||||<0.001
72423476|NCT01462162|144357810|SUPERIORITY_OR_OTHER||||||<|0.005|||||||t-test, 2 sided|||Baseline for Week 24 versus Week 24||||<0.005
72423477|NCT01462162|144357811|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||Baseline for Week 12 versus Week 12||||<0.001
72332704|NCT03641716|144189785|OTHER||||||<|0.01||||||a prior threshold for statistical significance set at p\<.05|t-test, 2 sided|We ran a paired samples t-test with pre/post intervention data (from baseline and 3-month assessments).||After examining the data to ensure it met the statistical assumptions (e.g. normality, no outliers), we ran a paired-sample pre-post t-test to examine the difference in scores from baseline to 3 months on the NutriSTEP (Screening Tool for Every Preschooler) assessment.||||<.01
72332705|NCT02487654|144189786|SUPERIORITY||||||<|0.05|||||||Log Rank|||||||<0.05
72332706|NCT03724981|144189838|SUPERIORITY||||||<|0.0001|||||||Prescott test|||||||<0.0001
72332707|NCT03724981|144189839|SUPERIORITY||||||<|0.0001|||||||Prescott test|||||||<0.0001
72423478|NCT01462162|144357811|SUPERIORITY_OR_OTHER||||||<|0.005|||||||t-test, 2 sided|||Baseline for Week 24 versus Week 24||||<0.005
72423479|NCT01462162|144357812|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||Baseline for Week 12 versus Week 12||||<0.001
72423480|NCT01462162|144357812|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||Baseline for Week 24 versus Week 24||||<0.001
72423481|NCT03485911|144357816|SUPERIORITY||negative binomial regression model|30.0||||0.024|TWO_SIDED|95.0|4.6|48.7|||negative binomial regression model|||||48.7|4.6|0.024
72423482|NCT03485911|144357816|SUPERIORITY||negative binomial regression model|44.2|||<|0.001|TWO_SIDED|95.0|23.0|59.5|||negative binomial regression model|||||59.5|23.0|<0.001
72423483|NCT03485911|144357818|SUPERIORITY||Mean Difference (Final Values)|-2.77||||0.453|TWO_SIDED|95.0|-10.08|4.53|||mixed-model repeated measures analysis|||Numerical difference in change from baseline of AE-QoL total score between treatment groups.||4.53|-10.08|0.453
72423484|NCT03485911|144357818|SUPERIORITY||Mean Difference (Final Values)|-4.9||||0.188|TWO_SIDED|95.0|-12.23|2.43|||mixed-model repeated measures analysis|||Numerical difference in change from baseline of AE-QoL total score between treatment groups.||2.43|-12.23|0.188
72423485|NCT03485911|144357819|SUPERIORITY||Difference in Least Square Means|-0.062||||0.025|TWO_SIDED|95.0|-0.117|-0.008|||ANCOVA|||Numerical differences from the placebo treatment in the LSM proportion of the 169 days of treatment with angioedema symptoms. In the event that the first secondary endpoint did not meet statistical significance in the hierarchical testing scheme, testing of the second secondary endpoint of proportion of days with angioedema symptoms through 24 weeks for statistical significance would not be completed. P-values that are reported are nominal.||-0.008|-0.117|0.025
72423486|NCT03485911|144357819|SUPERIORITY||Difference in Least Square Means|-0.078||||0.006|TWO_SIDED|95.0|-0.133|-0.023|||ANCOVA|||Numerical differences from the placebo treatment in the LSM proportion of the 169 days of treatment with angioedema symptoms. In the event that the first secondary endpoint did not meet statistical significance in the hierarchical testing scheme, testing of the second secondary endpoint of number and proportion of days with angioedema symptoms through 24 weeks for statistical significance would not be completed. P-values that are reported are nominal.||-0.023|-0.133|0.006
72332708|NCT00678535|144189879|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.091||||0.3158||95.0|0.92|1.292|||Stratified log rank||Kaplan-Meier method was used to estimate median PFS time. HR was calculated using Cox proportional hazards model stratified by randomization strata.|Primary efficacy analysis: To test equality of progression free survival time between treatment groups, applying the two-sided stratified log-rank test (randomization strata: disease stage, previous oesophagectomy/gastrectomy and prior(neo-) adjuvant(radio) chemotherapy, α=5%).||1.292|0.920|0.3158
72423487|NCT03485911|144357820|SUPERIORITY||negative binomial regression model|30.4||||0.026|TWO_SIDED|95.0|4.3|49.3|||negative binomial regression model|||In the event that the first secondary endpoint did not meet statistical significance in the hierarchical testing scheme, testing of the third secondary endpoint of rate of expert-confirmed HAE attacks during dosing in the effective treatment period for statistical significance would not be completed. P-values reported are nominal.||49.3|4.3|0.026
72332709|NCT00678535|144189880|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.004||||0.9547||95.0|0.866|1.165|||Stratified log rank||Kaplan-Meier method was used to estimate median OS time. HR was calculated using Cox proportional hazards model stratified by randomization strata.|To test equality of OS time between treatment groups, applying the two-sided stratified log-rank test (randomization strata: disease stage, previous oesophagectomy/gastrectomy and prior (neo-) adjuvant(radio) chemotherapy, α=5%)||1.165|0.866|0.9547
72332710|NCT00678535|144189881|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.0435||||0.7696||95.0|0.7844|1.3882|||Cochran-Mantel-Haenszel|||The best overall response rate was compared with the Cochran-Mantel-Haenszel test (strata: disease stage, previous oesophagectomy/gastrectomy and prior(neo-) adjuvant(radio) chemotherapy, two-sided with α=5%).||1.3882|0.7844|0.7696
72423488|NCT03485911|144357820|SUPERIORITY||negative binomial regression model|46.5|||<|0.001|TWO_SIDED|95.0|25.6|61.5|||negative binomial regression model|||In the event that the first secondary endpoint did not meet statistical significance in the hierarchical testing scheme, testing of the third secondary endpoint of rate of expert-confirmed HAE attacks during dosing in the effective treatment period for statistical significance would not be completed. P-values reported are nominal.||61.5|25.6|<0.001
72423489|NCT00909480|144357831|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin: 0.4%.|Mean Difference (Net)|0.3003||||||95.0|0.1427|0.458|||ANCOVA|Full analysis set, Model adjusted for: HbA1c at baseline, previous oral anti-diabetic treatment and country.||||0.4580|0.1427|
72423490|NCT00861601|144357846|SUPERIORITY_OR_OTHER|||||||0.0104||95.0||||Linearity. This analysis is based on each participants' change in platelet count.|ANCOVA|No adjustment for multiplicity was made because this analysis was exploratory.||||||0.0104
72423491|NCT00861601|144357846|SUPERIORITY_OR_OTHER|||||||0.0057||95.0||||Saturation at the medium dose. This analysis is based on each participants' change in platelet count.|ANCOVA|No adjustment for multiplicity was made because this analysis was exploratory.||||||0.0057
72423492|NCT00861601|144357846|SUPERIORITY_OR_OTHER|||||||0.0808||95.0||||Onset of response at the higher dose. This analysis is based on each participants' change in platelet count.|ANCOVA|No adjustment for multiplicity was made because this analysis was exploratory.||||||0.0808
72423493|NCT00861601|144357847|SUPERIORITY_OR_OTHER|||||||0.0116||95.0||||Linearity. This analysis is based on each participants' change in platelet count.|ANCOVA|No adjustment for multiplicity was made because this analysis was exploratory.||||||0.0116
72423494|NCT00861601|144357847|SUPERIORITY_OR_OTHER|||||||0.0066||95.0||||Saturation at the medium dose. This analysis is based on each participants' change in platelet count.|ANCOVA|No adjustment for multiplicity was made because this analysis was exploratory.||||||0.0066
72423495|NCT00861601|144357847|SUPERIORITY_OR_OTHER|||||||0.0846||95.0||||Onset of response at the higher dose. This analysis is based on each participants' change in platelet count.|ANCOVA|No adjustment for multiplicity was made because this analysis was exploratory.||||||0.0846
72332711|NCT02578680|144189926|SUPERIORITY||Hazard Ratio (HR)|0.52|||<|1e-05|TWO_SIDED|95.0|0.43|0.64|||Log Rank||Based on Cox regression model with treatment as a covariate stratified by PD-L1 status (≥1% vs. \<1%), platinum chemotherapy (cisplatin vs. carboplatin) \& smoking status (never vs. former/current). Pembrolizumab=numerator; Control=denominator.|||0.64|0.43|<0.00001
72423496|NCT05436912|144357886|OTHER||Geometric Mean Ratio|168.9||||0.3601|TWO_SIDED|90.0|61.3|465.3|||t-test, 2 sided||Geometric mean ratio for natural log transformed parameter (expressed as a percent) and 90% confidence interval for geometric mean ratio of natural log transformed parameter (expressed as a percent), natural log transformed back to the linear scale.|||465.3|61.3|0.3601
72423497|NCT05436912|144357886|OTHER||Geometric Mean Ratio|92.2||||0.9146|TWO_SIDED|90.0|23.0|368.9|||t-test, 2 sided||Geometric mean ratio for natural log transformed parameter (expressed as a percent) and 90% confidence interval for geometric mean ratio of natural log transformed parameter (expressed as a percent), natural log transformed back to the linear scale.|||368.9|23.0|0.9146
72423498|NCT05436912|144357886|OTHER||Geometric Mean Ratio|119.6||||0.7478|TWO_SIDED|90.0|43.4|329.3|||t-test, 2 sided||Geometric mean ratio for natural log transformed parameter (expressed as a percent) and 90% confidence interval for geometric mean ratio of natural log transformed parameter (expressed as a percent), natural log transformed back to the linear scale.|||329.3|43.4|0.7478
72423499|NCT05436912|144357888|OTHER||Geometric Mean Ratio|126.1||||0.4279|TWO_SIDED|90.0|74.8|212.8|||t-test, 2 sided||Geometric mean ratio for natural log transformed parameter (expressed as a percent) and 90% confidence interval for geometric mean ratio of natural log transformed parameter (expressed as a percent), natural log transformed back to the linear scale.|||212.8|74.8|0.4279
72423500|NCT05436912|144357888|OTHER||Geometric Mean Ratio|92.4||||0.8341|TWO_SIDED|90.0|46.4|183.9|||t-test, 2 sided||Geometric mean ratio for natural log transformed parameter (expressed as a percent) and 90% confidence interval for geometric mean ratio of natural log transformed parameter (expressed as a percent), natural log transformed back to the linear scale.|||183.9|46.4|0.8341
72423501|NCT05436912|144357888|OTHER||Geometric Mean Ratio|169.1||||0.1159|TWO_SIDED|90.0|97.1|294.6|||t-test, 2 sided||Geometric mean ratio for natural log transformed parameter (expressed as a percent) and 90% confidence interval for geometric mean ratio of natural log transformed parameter (expressed as a percent), natural log transformed back to the linear scale.|||294.6|97.1|0.1159
72423502|NCT05436912|144357889|OTHER||Geometric Mean Ratio|126.0||||0.4289|TWO_SIDED|90.0|74.8|212.4|||t-test, 2 sided||Geometric mean ratio for natural log transformed parameter (expressed as a percent) and 90% confidence interval for geometric mean ratio of natural log transformed parameter (expressed as a percent), natural log transformed back to the linear scale.|||212.4|74.8|0.4289
72423503|NCT05436912|144357889|OTHER||Geometric Mean Ratio|92.3||||0.8322|TWO_SIDED|90.0|46.5|183.3|||t-test, 2 sided||Geometric mean ratio for natural log transformed parameter (expressed as a percent) and 90% confidence interval for geometric mean ratio of natural log transformed parameter (expressed as a percent), natural log transformed back to the linear scale.|||183.3|46.5|0.8322
72423504|NCT05436912|144357889|OTHER||Geometric Mean Ratio|169.6||||0.1131|TWO_SIDED|90.0|97.6|294.6|||t-test, 2 sided||Geometric mean ratio for natural log transformed parameter (expressed as a percent) and 90% confidence interval for geometric mean ratio of natural log transformed parameter (expressed as a percent), natural log transformed back to the linear scale.|||294.6|97.6|0.1131
72423505|NCT04750655|144357912|OTHER|||||||1|||||||Kruskal-Wallis|||Used the Kruskal-Wallis (nonparametric one-way ANOVA), comparing all 3 arms. Note that for each individual, a single number (normalized read) is obtained.||||1
72423506|NCT01216163|144357922|SUPERIORITY_OR_OTHER||Least-squares (LS) mean difference|17.68|||<|0.001|TWO_SIDED|95.0|13.08|22.27||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR), gender and treatment-by-baseline PSR terms.|ANOVA|||Treatment difference(Ibuprofen sodium - placebo) and 95 percent(%) confidence interval(CI):based on LS means from Analysis of Variance(ANOVA).Type I error controlled at 5% significance level(2-sided) by testing co-primary endpoints sequentially:Ibuprofen sodium(IBU Na) versus(vs) Placebo(PBO), IBU Na vs Acetaminophen(APAP), APAP vs PBO for SPRID 0-6 then time to meaningful relief at each comparison.If comparison at preceding step was significant only then subsequent comparisons were significant.||22.27|13.08|<0.001
72423507|NCT01216163|144357922|SUPERIORITY_OR_OTHER||LS mean difference|4.96||||0.01|TWO_SIDED|95.0|1.21|8.72||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms.|ANOVA|||Treatment difference (Ibuprofen sodium - Acetaminophen) and 95% CI: based on LS means from ANOVA. Type I error controlled at 5% significance level(2-sided) by testing co-primary endpoints sequentially:IBU Na vs PBO, IBU Na vs APAP, APAP vs PBO for SPRID 0-6 then time to meaningful relief at each comparison.If comparison at preceding step was significant only then subsequent comparisons were significant.||8.72|1.21|0.010
72423508|NCT01216163|144357922|SUPERIORITY_OR_OTHER||LS mean difference|12.71|||<|0.001|TWO_SIDED|95.0|8.12|17.3||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms.|ANOVA|||Treatment difference (Acetaminophen - Placebo) and 95% CI: based on LS means from ANOVA. Type I error controlled at 5% significance level(2-sided) by testing co-primary endpoints sequentially:IBU Na vs PBO, IBU Na vs APAP, APAP vs PBO for SPRID 0-6 then time to meaningful relief at each comparison.If comparison at preceding step was significant only then subsequent comparisons were significant.||17.30|8.12|<0.001
72423509|NCT01216163|144357923|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|11.84|||<|0.001|TWO_SIDED|95.0|5.13|27.36||p-value was calculated using PH model with treatment, baseline PSR and gender terms.|Proportional hazards model|||Hazard Ratio (HR) and corresponding 95% CI were calculated based on the Wald statistic from the proportional hazards (PH) model. Type I error controlled at 5% significance level(2-sided) by testing co-primary endpoints sequentially:IBU Na vs PBO, IBU Na vs APAP, APAP vs PBO for SPRID 0-6 then time to meaningful relief at each comparison.If comparison at preceding step was significant only then subsequent comparisons were significant.||27.36|5.13|<0.001
72423510|NCT01216163|144357923|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.14||||0.468|TWO_SIDED|95.0|0.81|1.6||p-value was calculated using PH model with treatment, baseline PSR and gender terms.|Proportional hazards model|||HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model. Type I error controlled at 5% significance level(2-sided) by testing co-primary endpoints sequentially:IBU Na vs PBO, IBU Na vs APAP, APAP vs PBO for SPRID 0-6 then time to meaningful relief at each comparison.If comparison at preceding step was significant only then subsequent comparisons were significant.||1.60|0.81|0.468
72332712|NCT02578680|144189927|SUPERIORITY||Hazard Ratio (HR)|0.49|||<|1e-05|TWO_SIDED|95.0|0.38|0.64|||Log Rank||Based on Cox regression model with treatment as a covariate stratified by PD-L1 status (≥1% vs. \<1%), platinum chemotherapy (cisplatin vs. carboplatin) \& smoking status (never vs. former/current). Pembrolizumab=numerator; Control=denominator.|||0.64|0.38|<0.00001
72332713|NCT02578680|144189928|SUPERIORITY||Difference in Percentage vs. Control|28.5|||<|0.0001|TWO_SIDED|95.0|21.1|35.4||H0:Difference in percentages=0 vs H1:Difference in percentages\>0|Stratified Miettinen and Nurminen||Miettinen and Nurminen method with treatment as a covariate stratified by PD-L1 status (≥1% vs. \<1%), platinum chemotherapy (cisplatin vs. carboplatin) \& smoking status (never vs. former/current). Pembrolizumab=numerator; Control=denominator.|||35.4|21.1|<0.0001
72332714|NCT02578680|144189932|SUPERIORITY||Hazard Ratio (HR)|0.49|||<|1e-05|TWO_SIDED|95.0|0.41|0.59|||Log Rank||Based on Cox regression model with treatment as a covariate stratified by PD-L1 status (≥1% vs. \<1%), platinum chemotherapy (cisplatin vs. carboplatin) \& smoking status (never vs. former/current). Pembrolizumab=numerator; Control=denominator.|||0.59|0.41|<0.00001
72332715|NCT03831191|144189989|SUPERIORITY||Odds Ratio (OR)|0.55||||0.638|TWO_SIDED|95.0|0.04|6.81|||Regression, Logistic|||||6.81|0.04|0.638
72332716|NCT03831191|144189989|SUPERIORITY||Odds Ratio (OR)|0.69||||0.773|TWO_SIDED|95.0|0.05|8.76|||Regression, Logistic|||||8.76|0.05|0.773
72332717|NCT03831191|144189989|SUPERIORITY||Odds Ratio (OR)|0.58||||0.671|TWO_SIDED|95.0|0.05|7.26|||Regression, Logistic|||||7.26|0.05|0.671
72332718|NCT03831191|144189990|SUPERIORITY||Risk Difference (RD)|-4.0|||>|0.999|TWO_SIDED|95.0|-27.2|19.9|||Fisher Exact|||||19.9|-27.2|>0.999
72332719|NCT03831191|144189990|SUPERIORITY||Risk Difference (RD)|4.5|||>|0.999|TWO_SIDED|95.0|-20.7|30.8|||Fisher Exact|||||30.8|-20.7|>0.999
72332720|NCT03831191|144189990|SUPERIORITY||Risk Difference (RD)|-19.0||||0.107|TWO_SIDED|95.0|-40.0|0.2|||Fisher Exact|||||0.2|-40.0|0.107
72332721|NCT03831191|144189991|SUPERIORITY||Risk Difference (RD)|0.2|||>|0.999|TWO_SIDED|95.0|-18.1|19.3|||Fisher Exact|||||19.3|-18.1|>0.999
72332722|NCT03831191|144189991|SUPERIORITY||Risk Difference (RD)|-4.8|||>|0.999|TWO_SIDED|95.0|-22.7|14.1|||Fisher Exact|||||14.1|-22.7|>0.999
72332723|NCT03831191|144189991|SUPERIORITY||Risk Difference (RD)|-4.8|||>|0.999|TWO_SIDED|95.0|-22.7|11.2|||Fisher Exact|||||11.2|-22.7|>0.999
72332724|NCT03831191|144189992|SUPERIORITY||Risk Difference (RD)|0.0|||||TWO_SIDED|95.0|0.0|0.0||||||||0.0|0.0|
72332725|NCT03831191|144189992|SUPERIORITY||Risk Difference (RD)|0.0|||||TWO_SIDED|95.0|0.0|0.0||||||||0.0|0.0|
72332726|NCT03831191|144189992|SUPERIORITY||Risk Difference (RD)|0.0|||||TWO_SIDED|95.0|0.0|0.0||||||||0.0|0.0|
72423511|NCT01216163|144357923|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|10.43|||<|0.001|TWO_SIDED|95.0|4.5|24.17||p-value was calculated using PH model with treatment, baseline PSR and gender terms.|Proportional hazards model|||HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model. Type I error controlled at 5% significance level(2-sided) by testing co-primary endpoints sequentially:IBU Na vs PBO, IBU Na vs APAP, APAP vs PBO for SPRID 0-6 then time to meaningful relief at each comparison.If comparison at preceding step was significant only then subsequent comparisons were significant.||24.17|4.50|<0.001
72423512|NCT01216163|144357924|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|14.06|||<|0.001|TWO_SIDED|95.0|6.02|32.8||p-value was calculated using PH model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Proportional hazards model|||HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model.||32.80|6.02|<0.001
72423513|NCT01216163|144357924|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.19||||0.323|TWO_SIDED|95.0|0.84|1.68||p-value was calculated using PH model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Proportional hazards model|||HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model.||1.68|0.84|0.323
72423514|NCT01216163|144357924|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|11.81|||<|0.001|TWO_SIDED|95.0|5.06|27.59||p-value was calculated using PH model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Proportional hazards model|||HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model.||27.59|5.06|<0.001
72423515|NCT01216163|144357925|SUPERIORITY_OR_OTHER||LS mean difference|0.53|||<|0.001|TWO_SIDED|95.0|0.24|0.83||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||0.25 hours: Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.83|0.24|<0.001
72423516|NCT01216163|144357925|SUPERIORITY_OR_OTHER||LS mean difference|0.2||||0.101|TWO_SIDED|95.0|-0.04|0.44||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||0.25 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.44|-0.04|0.101
72332727|NCT03831191|144189993|SUPERIORITY||Median Difference (Net)|6.55||||0.31|TWO_SIDED|95.0|-6.36|19.45|||Mixed Models Analysis|||||19.45|-6.36|0.310
72332728|NCT03831191|144189993|SUPERIORITY||Mean Difference (Net)|5.56||||0.393|TWO_SIDED|95.0|-7.5|18.63|||Mixed Models Analysis|||||18.63|-7.50|0.393
72332729|NCT03831191|144189993|SUPERIORITY||Mean Difference (Net)|3.59||||0.564|TWO_SIDED|95.0|-8.91|16.08|||Mixed Models Analysis|||||16.08|-8.91|0.564
72332730|NCT03831191|144189994|SUPERIORITY||Mean Difference (Net)|7.61||||0.356|TWO_SIDED|95.0|-8.82|24.05|||Mixed Models Analysis|||||24.05|-8.82|0.356
72332731|NCT03831191|144189994|SUPERIORITY||Mean Difference (Net)|2.33||||0.783|TWO_SIDED|95.0|-14.64|19.3|||Mixed Models Analysis|||||19.30|-14.64|0.783
72332732|NCT03831191|144189994|SUPERIORITY||Mean Difference (Net)|6.52||||0.414|TWO_SIDED|95.0|-9.4|22.43|||Mixed Models Analysis|||||22.43|-9.40|0.414
72332733|NCT02300558|144189997|OTHER|||||||0.0087|||||||paired t- test|||Based on a 2-sided, paired t-test ( α = 0.05), and a standard deviation (SD) of 30 msec, a sample size of 40 participants provided greater than 95% power assuming a difference in mean daytime QTcF interval (AUC0-6/6) as measured by standard 12-lead ECG between baseline and Week 24 of 20 msec. The null hypothesis was that the mean difference between the baseline and Week 24 mean daytime QTcF interval was zero.||||0.0087
72332734|NCT00712725|144190041|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value constructed from trend test of dose response, by testing the slope of the MK3207 dose covariate (all dose groups included) in a generalized linear regression model with PF at 2 hours postdose as the dependent variable.|Generalized linear regression model|Model adjusted for geographic region (US, ex-US), baseline severity (moderate, severe), treatment and age (continuous), using identity link function.||||||<0.001
72332735|NCT00712725|144190042|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value constructed from trend test of dose response, by testing the slope of the MK3207 dose covariate (all dose groups included) in a generalized linear regression model with binary response PR at 2 hours postdose as the dependent variable.|Generalized linear regression model|Model adjusted for geographic region (US, ex-US), baseline severity (moderate, severe), treatment and age (continuous), using identity link function.||||||<0.001
72332736|NCT00712725|144190043|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value constructed from trend test of dose response, by testing the slope of the MK3207 dose covariate (all dose groups included) in a generalized linear regression model with Absence of Photophobia at 2 hours postdose as the dependent variable.|Generalized linear regression model|Model adjusted for geographic region (US, ex-US), baseline severity (moderate, severe), treatment and age (continuous), using identity link function.||||||<0.001
72332737|NCT00712725|144190044|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value constructed from trend test of dose response, by testing the slope of the MK3207 dose covariate (all dose groups included) in a generalized linear regression model with Absence of Phonophobia at 2 hours postdose as the dependent variable.|Generalized linear regression model|Model adjusted for geographic region (US, ex-US), baseline severity (moderate, severe), treatment and age (continuous), using identity link function.||||||<0.001
72332738|NCT00712725|144190045|SUPERIORITY_OR_OTHER|||||||0.007||95.0||||p-value constructed from trend test of dose response, by testing the slope of the MK3207 dose covariate (all dose groups included) in a generalized linear regression model with Absence of Nausea at 2 hours postdose as the dependent variable.|Generalized linear regression model|Model adjusted for geographic region (US, ex-US), baseline severity (moderate, severe), treatment and age (continuous), using identity link function.||||||0.007
72332739|NCT00712725|144190046|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value constructed from trend test of dose response, by testing the slope of the MK3207 dose covariate (all dose groups included) in a generalized linear regression model with binary response SPF 2-24 hours postdose as the dependent variable.|Generalized linear regression model|Model adjusted for geographic region (US, ex-US), baseline severity (moderate, severe), treatment and age (continuous), using identity link function.||||||<0.001
72332740|NCT03709277|144190050|SUPERIORITY|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||||||0.001
72332741|NCT03709277|144190051|SUPERIORITY|||||||0.003|||||||Wilcoxon (Mann-Whitney)|||||||0.003
72332742|NCT03709277|144190053|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
72332743|NCT05248997|144190066|SUPERIORITY||Difference in least square mean|-0.09||||0.7782|TWO_SIDED|95.0|-0.71|0.53||LM included baseline value as covariate,\& fixed effects for treatment group,stratification factor,scheduled time point(TP),TP by treatment group interaction.Repeated measures:modelled by unstructured covariance structure for within participant error.|Linear model (LM)|||||0.53|-0.71|0.7782
72332744|NCT05248997|144190067|SUPERIORITY||Difference in least square mean|-0.29||||0.7079|TWO_SIDED|95.0|-1.83|1.24||LM included baseline value as covariate, and fixed effects for treatment group,stratification factor,scheduled TP, TP by treatment group interaction.Repeated measures:modelled by unstructured covariance structure for within participant error.|Linear model (LM)|||||1.24|-1.83|0.7079
72332745|NCT05248997|144190068|SUPERIORITY||Difference in least square mean|-0.23||||0.4398|TWO_SIDED|95.0|-0.81|0.36||LM included baseline value as covariate, and fixed effects for treatment group,stratification factor,scheduled TP, TP by treatment group interaction.Repeated measures:modelled by unstructured covariance structure for within participant error.|Linear model (LM)|||||0.36|-0.81|0.4398
72332746|NCT05248997|144190069|SUPERIORITY||Difference in least square mean|0.04||||0.889|TWO_SIDED|95.0|-0.51|0.59||LM included baseline value as covariate, and fixed effects for treatment group,stratification factor,scheduled TP, TP by treatment group interaction.Repeated measures:modelled by unstructured covariance structure for within participant error.|Linear model (LM)|||||0.59|-0.51|0.8890
72332747|NCT05248997|144190070|SUPERIORITY||Percentage difference|3.8||||0.6412|TWO_SIDED|95.0|-12.1|19.7|||Mantel-Haenszel|Stratified by presence of nasal polyps at randomization with Mantel-Haenszel risk estimation.||||19.7|-12.1|0.6412
72332748|NCT05248997|144190071|SUPERIORITY||Percentage difference|-2.7||||0.5001|TWO_SIDED|95.0|-10.6|5.2|||Mantel-Haenszel|Stratified by presence of nasal polyps at randomization with Mantel-Haenszel risk estimation.||||5.2|-10.6|0.5001
72423517|NCT01216163|144357925|SUPERIORITY_OR_OTHER||LS mean difference|0.33||||0.029|TWO_SIDED|95.0|0.03|0.62||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||0.25 hours: Treatment difference (Acetaminophen - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.62|0.03|0.029
72332749|NCT01453205|144190072|SUPERIORITY_OR_OTHER|||||||0.5543|||||||Cochran-Mantel-Haenszel|||||||0.5543
72332750|NCT01453205|144190073|SUPERIORITY_OR_OTHER|||||||0.8567|||||||Log Rank|||||||0.8567
72332751|NCT01453205|144190074|SUPERIORITY_OR_OTHER|||||||0.7412|||||||Log Rank|||||||0.7412
72332752|NCT01453205|144190075|SUPERIORITY_OR_OTHER|||||||0.9996|||||||Log Rank|||||||0.9996
72332753|NCT01453205|144190076|SUPERIORITY_OR_OTHER|||||||0.1686|||||||Log Rank|||||||0.1686
72332754|NCT02602275|144190112|SUPERIORITY|||||||0.004||||||Significance level is 0.05, corrected for multiple comparisons in the search volume which is anatomically defined by the Automated Anatomical Labelling Atlas (AAL) coordinates.|Paired t-test|||||||0.004
72332755|NCT02602275|144190113|SUPERIORITY||||||>|0.05||||||Significance level is 0.05, corrected for multiple comparisons in the search volume which is anatomically defined by the Automated Anatomical Labelling Atlas (AAL) coordinates.|Paired t-test|||||||>0.05
72423518|NCT01216163|144357925|SUPERIORITY_OR_OTHER||LS mean difference|1.44|||<|0.001|TWO_SIDED|95.0|1.01|1.87||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||0.5 hours: Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.87|1.01|<0.001
72423519|NCT01216163|144357925|SUPERIORITY_OR_OTHER||LS mean difference|0.24||||0.178|TWO_SIDED|95.0|-0.11|0.59||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||0.5 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.59|-0.11|0.178
72423520|NCT01216163|144357925|SUPERIORITY_OR_OTHER||LS mean difference|1.2|||<|0.001|TWO_SIDED|95.0|0.77|1.63||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||0.5 hours: Treatment difference (Acetaminophen - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.63|0.77|<0.001
72423521|NCT01216163|144357925|SUPERIORITY_OR_OTHER||LS mean difference|2.07|||<|0.001|TWO_SIDED|95.0|1.64|2.49||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1 hour: Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||2.49|1.64|<0.001
72423522|NCT01216163|144357925|SUPERIORITY_OR_OTHER||LS mean difference|0.44||||0.014|TWO_SIDED|95.0|0.09|0.78||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1 hour: Treatment difference (Ibuprofen sodium - Acetaminophen) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.78|0.09|0.014
72423523|NCT01216163|144357925|SUPERIORITY_OR_OTHER||LS mean difference|1.63|||<|0.001|TWO_SIDED|95.0|1.21|2.06||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1 hour: Treatment difference (Acetaminophen - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||2.06|1.21|<0.001
72423524|NCT01216163|144357925|SUPERIORITY_OR_OTHER||LS mean difference|2.25|||<|0.001|TWO_SIDED|95.0|1.79|2.7||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1.5 hours: Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||2.70|1.79|<0.001
72423525|NCT01216163|144357925|SUPERIORITY_OR_OTHER||LS mean difference|0.37||||0.055|TWO_SIDED|95.0|-0.01|0.74||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1.5 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.74|-0.01|0.055
72423526|NCT01216163|144357925|SUPERIORITY_OR_OTHER||LS mean difference|1.88|||<|0.001|TWO_SIDED|95.0|1.43|2.34||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1.5 hours: Treatment difference (Acetaminophen - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||2.34|1.43|<0.001
72423527|NCT01216163|144357925|SUPERIORITY_OR_OTHER||LS mean difference|2.31|||<|0.001|TWO_SIDED|95.0|1.8|2.83||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||2 hours: Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||2.83|1.80|<0.001
72423528|NCT01216163|144357925|SUPERIORITY_OR_OTHER||LS mean difference|0.51||||0.019|TWO_SIDED|95.0|0.08|0.93||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||2 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.93|0.08|0.019
72423529|NCT01216163|144357925|SUPERIORITY_OR_OTHER||LS mean difference|1.81|||<|0.001|TWO_SIDED|95.0|1.29|2.32||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||2 hours: Treatment difference (Acetaminophen - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||2.32|1.29|<0.001
72423530|NCT01216163|144357925|SUPERIORITY_OR_OTHER||LS mean difference|2.1|||<|0.001|TWO_SIDED|95.0|1.53|2.66||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||3 hours: Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||2.66|1.53|<0.001
72423531|NCT01216163|144357925|SUPERIORITY_OR_OTHER||LS mean difference|0.59||||0.013|TWO_SIDED|95.0|0.13|1.05||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||3 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.05|0.13|0.013
72332756|NCT02602275|144190114|SUPERIORITY||||||<|0.001||||||Significance level was 0.05.|Paired t-test|The outcome was deemed exploratory, as multiplicity was controlled using a priori ordered hypotheses, but the preceding endpoint was not met.||||||<0.001
72332757|NCT02602275|144190115|SUPERIORITY||||||>|0.05||||||Significance level is 0.05, corrected for multiple comparisons in the search volume which is anatomically defined by the Automated Anatomical Labelling Atlas (AAL) coordinates.|Paired t-test|||||||>0.05
72332758|NCT02602275|144190116|SUPERIORITY||||||<|0.05||||||Significance level is 0.05, corrected for multiple comparisons in the search volume which is anatomically defined by the AAL (Automated Anatomical Labelling Atlas) coordinates.|Paired t-test|The outcome was deemed exploratory, as multiplicity was controlled using a priori ordered hypotheses, but a preceding endpoint was not met.||||||<0.05
72332759|NCT04262882|144190117|SUPERIORITY||Odds Ratio (OR)|1.67||||0.2|TWO_SIDED|95.0|0.77|3.64|||Regression, Logistic|Adjusted for age and religion. Analysis in GEE to account for dependence in repeated, dyadic data.|Reference group is the comparator arm|||3.64|0.77|0.20
72332760|NCT04262882|144190120|SUPERIORITY||Wald Chi-Square|35.2|||<|0.001|TWO_SIDED||||||Regression, Linear|Models control for age and religion. Models run using generalized estimating equations (GEE) to account for dependence in repeated, dyadic data.|Wald Chi-Square tests the overall arm\*time intervention effect across the timepoints.|||||<0.001
72332761|NCT04262882|144190120|SUPERIORITY||unstandardized beta|0.41|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|||||P-value is adjusted for multiple comparisons; this value is for the 7-month follow-up|Regression, Linear|Models control for age and religion. Models run using generalized estimating equations (GEE) to account for dependence in repeated, dyadic data.||||||<0.001
72332762|NCT04262882|144190120|SUPERIORITY||unstandardized beta|0.4|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|||||P-value is adjusted for multiple comparisons; this value is for the 10-month follow-up|Regression, Linear|Models control for age and religion. Models run using generalized estimating equations (GEE) to account for dependence in repeated, dyadic data.||||||<0.001
72332763|NCT04262882|144190121|SUPERIORITY||Wald Chi-Square|64.53|||<|0.001|TWO_SIDED|||||Models control for age and religion. Models run using generalized estimating equations (GEE) to account for dependence in repeated, dyadic data.|Regression, Linear||Wald Chi-Square tests the overall arm\*time intervention effect across the timepoints.||"Tests of significance for each follow-up time point:~7-months: unstandardized beta=1.08, standard error=0.14, p \< 0.001; 10-months: unstandardized beta=0.79, standard error=0.14, p \< 0.001"|||<0.001
72332764|NCT04262882|144190121|SUPERIORITY||Mean Difference (Final Values)|1.08|STANDARD_ERROR_OF_MEAN|0.14|<|0.001|TWO_SIDED|||||Adjusted for multiple comparisons; this value is for the 7-month follow-up|Regression, Linear|Models control for age and religion. Models run using generalized estimating equations (GEE) to account for dependence in repeated, dyadic data.||||||<0.001
72332765|NCT04262882|144190121|SUPERIORITY||unstandardized beta|0.79|STANDARD_ERROR_OF_MEAN|0.14|<|0.001|TWO_SIDED|||||Adjusted for multiple comparisons; this value is for the 10-month follow-up|Regression, Linear|Models control for age and religion. Models run using generalized estimating equations (GEE) to account for dependence in repeated, dyadic data.||||||<0.001
72332766|NCT04262882|144190122|SUPERIORITY||Wald Chi-Square|23.89|||<|0.001|TWO_SIDED||||||Regression, Linear|Models control for age and religion. Models run using generalized estimating equations (GEE) to account for dependence in repeated, dyadic data.||||||<0.001
72332767|NCT04262882|144190122|SUPERIORITY||unstandardized beta|0.31|STANDARD_ERROR_OF_MEAN|0.06|<|0.001|TWO_SIDED|||||P value is adjusted for multiple comparisons; this value is for the 7-month follow-up|Regression, Linear|Models control for age and religion. Models run using generalized estimating equations (GEE) to account for dependence in repeated, dyadic data.||||||<0.001
72332768|NCT04262882|144190122|SUPERIORITY||unstandardized beta|0.19|STANDARD_ERROR_OF_MEAN|0.05|<|0.001|TWO_SIDED|||||P-value is adjusted for multiple comparisons; this value is for the 10-month follow-up|Regression, Linear|Models control for age and religion. Models run using generalized estimating equations (GEE) to account for dependence in repeated, dyadic data.||||||<0.001
72332769|NCT04262882|144190123|SUPERIORITY||Wald Chi-Square|48.26|||<|0.001|TWO_SIDED||||||Regression, Linear|Models control for age and religion. Models were run using generalized estimating equations (GEE) to account for dependence in repeated, dyadic data.||||||<0.001
72332770|NCT04262882|144190123|SUPERIORITY||unstandardized beta|0.68|STANDARD_ERROR_OF_MEAN|0.12|<|0.001|TWO_SIDED|||||P-value is adjusted for multiple comparisons; this value is for the 7-month follow-up|Regression, Cox|Models control for age and religion. Models run using generalized estimating equations (GEE) to account for dependence in repeated, dyadic data.||||||<0.001
72332771|NCT04262882|144190123|SUPERIORITY||unstandardized beta|0.2|STANDARD_ERROR_OF_MEAN|0.1||0.04|TWO_SIDED|||||P-value is adjusted for multiple comparisons; this value is for the 10-month follow-up|Regression, Linear|Models control for age and religion. Models run using generalized estimating equations (GEE) to account for dependence in repeated, dyadic data.||||||0.04
72332772|NCT04262882|144190124|SUPERIORITY||Wald Chi-Square|9.87||||0.007|TWO_SIDED|||||Arm\*Time p value for 10-months follow up overall.|Regression, Linear|Model controls for age and religion. Model was run using generalized estimating equations (GEE) to account for dependence in repeated, dyadic data.||||||0.007
72332773|NCT04262882|144190124|SUPERIORITY|Models control for age and religion. Models run using generalized estimating equations (GEE) to account for dependence in repeated, dyadic data.|unstandardized beta|-0.16|STANDARD_ERROR_OF_MEAN|0.32||0.6|TWO_SIDED|||||P-value is adjusted for multiple comparisons; this value is for the 7-month follow-up|Regression, Linear|||||||0.60
72332774|NCT04262882|144190124|SUPERIORITY||Slope|-0.53|STANDARD_ERROR_OF_MEAN|0.07||0.07|TWO_SIDED|||||P-value is adjusted for multiple comparisons; this value is for the 10-month follow-up|Regression, Linear|Models control for age and religion. Models run using generalized estimating equations (GEE) to account for dependence in repeated, dyadic data.||||||0.07
72332775|NCT04262882|144190125|SUPERIORITY||Wald Chi-Square|10.42||||0.005|TWO_SIDED||||||Regression, Logistic|Model controls for age and religion. Model was run using generalized estimating equations (GEE) to account for dependence in repeated, dyadic data.||||||0.005
72332776|NCT04262882|144190125|SUPERIORITY||Odds Ratio (OR)|1.36||||0.05|TWO_SIDED|95.0|0.99|1.85||P-value is adjusted for multiple comparisons; this value is for the 7-month follow-up|Regression, Logistic|Models control for age and religion. Models run using generalized estimating equations (GEE) to account for dependence in repeated, dyadic data.||||1.85|0.99|0.05
72332777|NCT04262882|144190125|SUPERIORITY||Odds Ratio (OR)|0.96||||0.71|TWO_SIDED|95.0|0.75|1.22||P-value is adjusted for multiple comparisons; this value is for the 10-month follow-up|Regression, Logistic|Models control for age and religion. Models run using generalized estimating equations (GEE) to account for dependence in repeated, dyadic data.||||1.22|0.75|0.71
72332778|NCT04262882|144190126|SUPERIORITY||Wald Chi-Square|13.4||||0.001|TWO_SIDED||||||Regression, Linear|Model controls for age and religion. Model was run using generalized estimating equations (GEE) to account for dependence in repeated, dyadic data.||||||0.001
72332779|NCT04262882|144190126|SUPERIORITY||unstandardized beta|0.13|STANDARD_ERROR_OF_MEAN|0.07||0.07|TWO_SIDED|||||P-value is adjusted for multiple comparisons; this value is for the 7-month follow-up|Regression, Linear|Models control for age and religion. Models run using generalized estimating equations (GEE) to account for dependence in repeated, dyadic data.||||||0.07
72332780|NCT04262882|144190126|SUPERIORITY||unstandardized beta|0.21|STANDARD_ERROR_OF_MEAN|0.06|<|0.001|TWO_SIDED|||||P-value is adjusted for multiple comparisons; this value is for the 10-month follow-up|Regression, Linear|Models control for age and religion. Models run using generalized estimating equations (GEE) to account for dependence in repeated, dyadic data.||||||<0.001
72332781|NCT04262882|144190127|SUPERIORITY||Wald Chi-Square|78.81||||0.001|TWO_SIDED||||||Regression, Linear|Model controls for age and religion. Model was run using generalized estimating equations (GEE) to account for dependence in repeated, dyadic data.||||||0.001
72332782|NCT04262882|144190127|SUPERIORITY||unstandardized beta|1.19|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|||||P-value is adjusted for multiple comparisons; this value is for the 7-month follow-up|Regression, Linear|Models control for age and religion. Models run using generalized estimating equations (GEE) to account for dependence in repeated, dyadic data.||||||<0.001
72332783|NCT04262882|144190127|SUPERIORITY||unstandardized beta|1.65|STANDARD_ERROR_OF_MEAN|0.19||0.001|TWO_SIDED|||||P-value is adjusted for multiple comparisons; this value is for the 10-month follow-up|Regression, Linear|Models control for age and religion. Models run using generalized estimating equations (GEE) to account for dependence in repeated, dyadic data.||||||0.001
72332784|NCT04262882|144190128|SUPERIORITY||Wald Chi-Square|19.46|||<|0.001|TWO_SIDED||||||Regression, Linear|Model controls for age and religion. Model was run using generalized estimating equations (GEE) to account for dependence in repeated, dyadic data.||||||<0.001
72332785|NCT04262882|144190128|SUPERIORITY||unstandardized beta|-0.13|STANDARD_ERROR_OF_MEAN|0.05||0.008|TWO_SIDED|||||P-value is adjusted for multiple comparisons; this value is for the 7-month follow-up|Regression, Linear|Models control for age and religion. Models run using generalized estimating equations (GEE) to account for dependence in repeated, dyadic data.||||||0.008
72332786|NCT04262882|144190128|SUPERIORITY||unstandardized beta|-0.17|STANDARD_ERROR_OF_MEAN|0.04|<|0.001|TWO_SIDED|||||P-value is adjusted for multiple comparisons; this value is for the 10-month follow-up|Regression, Linear|Models control for age and religion. Models run using generalized estimating equations (GEE) to account for dependence in repeated, dyadic data.||||||<0.001
72332787|NCT03268954|144190137|SUPERIORITY||Hazard Ratio (HR)|0.968|||=|0.557|TWO_SIDED|95.0|0.757|1.238|||Log Rank|P-value comparing EFS between treatment groups was based on the 1-sided Cui-Hung-Wang weighted unstratified log-rank test.|HR:unadjusted stratified Cox proportional hazard regression with stratification(low-blast AML,IPSS-R risk groups=very high,high,or intermediate for HRMDS/CMML),treatment as factor.HR\<1:better prevention of EFS in combination arm than azacitidine arm.|||1.238|0.757|=0.557
72332788|NCT03268954|144190138|SUPERIORITY|P-value comparing OS between treatment groups was based on the 1-sided Cui-Hung-Wang weighted unstratified log-rank test.|Hazard Ratio (HR)|0.881|||=|0.181|TWO_SIDED|95.0|0.697|1.115|||Log Rank||HR:unadjusted stratified Cox proportional hazard regression with stratification(low-blast AML,IPSS-R risk groups=very high,high,or intermediate for HRMDS/CMML),treatment as factor.HR\<1: longer survival time in combination arm than azacitidine arm.|Overall Survival (OS)||1.115|0.697|=0.181
72332789|NCT03268954|144190143|SUPERIORITY||Hazard Ratio (HR)|1.037|||=|0.562|TWO_SIDED|95.0|0.66|1.63||P-value comparing time to AML Transformation between treatment groups was based on 1-sided stratified log-rank test stratified by IPSS-R risk groups of very high, high, or intermediate for HR MDS.|Log Rank||HR:unadjusted stratified Cox proportional HazardRegression with stratification(IPSS-R risk groups=very high,high,or intermediate for HRMDS/CMML),treatment as factor.HR\<1:better prevention of AML transformation in combination arm than azacitidine arm.|Time to AML Transformation in HR MDS Participants||1.630|0.660|=0.562
72332790|NCT03268954|144190143|SUPERIORITY||Hazard Ratio (HR)|1.512|||=|0.603|TWO_SIDED|95.0|0.068|33.773||P-value comparing time to AML Transformation between treatment groups was based on 1-sided stratified log-rank test stratified by IPSS-R risk groups of very high, high, or intermediate for HR CMML.|Log Rank||HR:unadjusted stratified Cox proportional HazardRegression with stratification(IPSS-R risk groups=very high,high,or intermediate for HRMDS/CMML),treatment as factor.HR\<1:better prevention of AML transformation in combination arm than azacitidine arm.|Time to AML Transformation in HR CMML Participants||33.773|0.068|=0.603
72332791|NCT03268954|144190143|SUPERIORITY||Hazard Ratio (HR)|1.034|||=|0.558|TWO_SIDED|95.0|0.663|1.61||P-value comparing time to AML Transformation between treatment groups was based on 1-sided stratified log-rank test stratified by IPSS-R risk groups of very high, high, or intermediate for HR CMML/MDS.|Log Rank||HR:unadjusted stratified Cox proportional HazardRegression with stratification(IPSS-R risk groups=very high,high,or intermediate for HRMDS/CMML),treatment as factor.HR\<1:better prevention of AML transformation in combination arm than azacitidine arm.|Time to AML Transformation in HR MDS/CMML Participants||1.610|0.663|=0.558
72332792|NCT03268954|144190144|SUPERIORITY||Absolute Rate Difference|-4.18|||=|0.374|TWO_SIDED|95.0|-13.18|4.83||P-value was obtained from a stratified Cochran-Mantel-Haenszel chi-square test stratified by low-blast AML, IPSS-R risk groups of very high, high, or intermediate for HR MDS/CMML.|Cochran-Mantel-Haenszel|||Number of Participants With Complete Remission (CR) and CR+Complete Remission with Incomplete Blood Count Recovery (CRi)||4.83|-13.18|=0.374
72332793|NCT03268954|144190149|SUPERIORITY||Absolute Rate Difference|-4.67|||=|0.329|TWO_SIDED|95.0|-13.72|4.39||P-value was obtained from a stratified Cochran-Mantel-Haenszel chi-square test stratified by low-blast AML, Revised International Prognostic Scoring System (IPSS-R) risk groups of very high, high, or intermediate for HR MDS/CMML.|Cochran-Mantel-Haenszel|||Number of Participants with OR||4.39|-13.72|=0.329
72332794|NCT03268954|144190150|SUPERIORITY||Absolute Rate Difference|-0.44|||=|0.891|TWO_SIDED|95.0|-10.03|9.15||P-value was obtained from a stratified Cochran-Mantel-Haenszel chi-square test stratified by low-blast AML, IPSS-R risk groups of very high, high, or intermediate for HR MDS/CMML.|Cochran-Mantel-Haenszel|||Number of Participants with OR2||9.15|-10.03|=0.891
72332795|NCT03268954|144190151|SUPERIORITY||Hazard Ratio (HR)|0.679|||=|0.072|TWO_SIDED|95.0|0.402|1.146|||Log Rank|P-value was based on 1-sided log-rank test stratified by low-blast AML,IPSS-R risk groups of very high,high,or intermediate for HR MDS/CMML.|Hazard ratio was based on an unadjusted stratified Cox proportional hazard regression model with stratification factors (low-blast AML, IPSS-R risk groups of very high, high, or intermediate for HR MDS/CMML) and treatment as a factor in the model.|Duration of CR||1.146|0.402|=0.072
72332796|NCT03268954|144190152|SUPERIORITY||Hazard Ratio (HR)|0.846|||=|0.373|TWO_SIDED|95.0|0.306|2.339||P-value comparing duration of CR+CRi between treatment groups was based on 1-sided unstratified log-rank.|Log Rank||Hazard ratio was based on an unadjusted unstratified Cox proportional hazard regression model with treatment as a factor in the model.|Duration of Complete Remission + Complete Remission with Incomplete Blood Count Recovery (CRi)||2.339|0.306|=0.373
72332797|NCT03268954|144190153|SUPERIORITY||Hazard Ratio (HR)|0.889|||=|0.32|TWO_SIDED|95.0|0.542|1.458||P-value comparing duration of PR or better response between treatment groups was based on 1-sided log-rank test stratified by low-blast AML, IPSS-R risk groups of very high, high, or intermediate for HR MDS/CMML.|Log Rank||Hazard ratio was based on an unadjusted stratified Cox proportional hazard regression model with stratification factors (low-blast AML, IPSS-R risk groups of very high, high, or intermediate for HR MDS/CMML) and treatment as a factor in the model.|Duration of Overall Response (OR)||1.458|0.542|=0.320
72332798|NCT03268954|144190154|SUPERIORITY||Hazard Ratio (HR)|0.796|||=|0.151|TWO_SIDED|95.0|0.514|1.231||P-value comparing duration of overall response 2 between treatment groups was based on 1-sided log-rank test stratified by low blast AML, IPSS-R risk groups of very high, high, or intermediate for HR MDS/CMML.|Log Rank||Hazard ratio was based on an unadjusted stratified Cox proportional hazard regression model with stratification factors (low-blast AML, IPSS-R risk groups of very high, high, or intermediate for HR MDS/CMML) and treatment as a factor in the model.|Duration of Overall Response 2 (OR2)||1.231|0.514|=0.151
72332799|NCT03268954|144190155|SUPERIORITY||Absolute Rate Difference|3.27|||=|0.573|TWO_SIDED|95.0|-9.02|15.55||P-value was obtained from a stratified Cochran-Mantel-Haenszel chi-square test.|Cochran-Mantel-Haenszel|||Percentage of Participants With RBC-transfusion Independence||15.55|-9.02|=0.573
72332800|NCT03268954|144190155|SUPERIORITY||Absolute Rate Difference|-3.43|||=|0.477|TWO_SIDED|95.0|-25.84|18.97||P-value was obtained from a stratified Cochran-Mantel-Haenszel chi-square test.|Cochran-Mantel-Haenszel|||Percentage of Participants With Platelet-transfusion Independence||18.97|-25.84|=0.477
72332801|NCT03268954|144190156|SUPERIORITY||Hazard Ratio (HR)|1.231|||=|0.774|TWO_SIDED|95.0|0.715|2.119||P-value comparing duration of RBC or platelet transfusion between treatment groups was based on 1-sided log-rank test stratified by low-blast AML, IPSS-R risk groups of very high, high, or intermediate for HR MDS/CMML.|Log Rank||HR:unadjusted Cox Proportional Hazard regression;stratification(low-blast AML,IPSS-R risk groups=very high,high,intermediate for HRMDS/CMML),treatment as factor.HR\<1:longer duration of transfusion independence in combination arm than azacitidine arm.|Duration of RBC Transfusion Independence||2.119|0.715|=0.774
72332802|NCT03268954|144190156|SUPERIORITY||Hazard Ratio (HR)|1.533|||=|0.801|TWO_SIDED|95.0|0.567|4.147||P-value comparing duration of platelet transfusion between treatment groups was based on 1-sided log-rank test stratified by low blast AML, IPSS-R risk groups of very high, high, or intermediate for HR MDS/CMML.|Log Rank||HR:unadjusted Cox Proportional Hazard regression;stratification(low-blast AML,IPSS-R risk groups=very high,high,intermediate for HRMDS/CMML),treatment as factor.HR\<1:longer duration of transfusion independence in combination arm than azacitidine arm.|Duration of Platelet Transfusion Independence||4.147|0.567|=0.801
72332803|NCT03268954|144190156|SUPERIORITY||Hazard Ratio (HR)|0.968|||=|0.45|TWO_SIDED|95.0|0.58|1.614||P-value comparing duration of RBC or platelet transfusion between treatment groups was based on 1-sided log-rank test stratified by low-blast AML, IPSS-R risk groups of very high, high, or intermediate for HR MDS/CMML.|Log Rank||HR:unadjusted Cox Proportional Hazard regression;stratification(low-blast AML,IPSS-R risk groups=very high,high,intermediate for HRMDS/CMML),treatment as factor.HR\<1:longer duration of transfusion independence in combination arm than azacitidine arm.|Duration of Transfusion Independence||1.614|0.580|=0.450
72332804|NCT03268954|144190157|SUPERIORITY||Hazard Ratio (HR)|0.88|||=|0.228|TWO_SIDED|95.0|0.628|1.234||P-value comparing time to first CR or PR or CRi (low-blast AML) between treatment groups was based on 1-sided stratified log-rank test stratified by low-blast AML,IPSS-R risk groups of very high,high,or intermediate for HR MDS/CMML.|Log Rank||Hazard ratio was based on an unadjusted stratified Cox proportional hazard regression model with stratification factors (low-blast AML, IPSS-R risk groups of very high, high, or intermediate for HR MDS/CMML) and treatment as a factor in the model.|Time to First Complete Remission (CR) or Partial Remission (PR) or Complete Remission with Incomplete Blood Count Recovery (CRi)||1.234|0.628|=0.228
72332805|NCT03268954|144190158|SUPERIORITY||Absolute Rate Difference|-5.46|||=|0.32|TWO_SIDED|95.0|-16.36|5.44||P-value was obtained from a stratified Cochran-Mantel-Haenszel chi-square test.|Cochran-Mantel-Haenszel|||Number of Participants With HI||5.44|-16.36|=0.320
72332806|NCT03268954|144190159|SUPERIORITY||Rate Difference|2.64|||||TWO_SIDED|95.0|-0.3|5.58||||||Number of Participants With at Least 1 Inpatient Hospital Admissions Related to HR MDS, CMML or Low-blast AML||5.58|-0.30|
72332807|NCT03268954|144190160|SUPERIORITY||Hazard Ratio (HR)|0.858|||=|0.084|TWO_SIDED|95.0|0.689|1.067||P-value was obtained from a stratified 1-sided log-rank test stratified by low-blast AML, IPSS-R risk groups of very high, high, or intermediate for HR MDS/CMML.|Log Rank||Hazard ratio was based on a stratified Cox proportional hazard regression model stratified by low-blast AML, IPSS-R risk groups of very high, high, or intermediate for HR MDS/CMML, with treatment as a factor in the model.|Time to Progressive Disease (PD), Relapse after CR (Low-blast AML), Relapse After CR or PR (HR MDS/CMML), or Death||1.067|0.689|=0.084
72332808|NCT03268954|144190161|SUPERIORITY||Hazard Ratio (HR)|0.75|||=|0.002|TWO_SIDED|95.0|0.615|0.913|||Log Rank|||||0.913|0.615|=0.002
72332809|NCT03268954|144190163|SUPERIORITY||Absolute Rate Difference|-2.85|||=|0.683|TWO_SIDED|95.0|-19.44|13.75||P-value for HR MDS/CMML was obtained from a stratified Cochran-Mantel-Haenszel chi-square test|Cochran-Mantel-Haenszel|||OR: HR MDS/CMML Participants||13.75|-19.44|=0.683
72332810|NCT03268954|144190163|SUPERIORITY||Absolute Rate Difference|2.36|||=|0.84|TWO_SIDED|95.0|-20.39|25.12||P-value for Low-blast AML was obtained from an unstratified Cochran-Mantel-Haenszel chi-square test.|Cochran-Mantel-Haenszel|||ORR: Low-blast AML Participants||25.12|-20.39|=0.840
72332811|NCT03268954|144190164|SUPERIORITY||Hazard Ratio (HR)|0.877|||=|0.24|TWO_SIDED|95.0|0.608|1.263||P-value comparing EFS between treatment groups was based on 1-sided log-rank test stratified by low-blast AML, IPSS-R risk groups of very high, high, or intermediate for HR MDS/CMML.|Log Rank||HR:unadjusted stratified Cox proportional hazard regression with stratification factors (IPSS-R risk groups=very high,high,or intermediate for HRMDS/CMML),treatment as factor.HR\<1:better prevention of EFS in combination arm than azacitidine arm.|Event-Free Survival in Participants who have TP53 Mutations, 17p Deletions, and/or are Determined to be in an Adverse Cytogenetic Risk Group||1.263|0.608|=0.240
72332812|NCT03268954|144190165|SUPERIORITY||Hazard Ratio (HR)|0.826|||=|0.145|TWO_SIDED|95.0|0.58|1.178||P-value comparing OS between treatment groups was based on 1-sided log-rank test stratified by low-blast AML, IPSS-R risk groups of very high, high, or intermediate for HR MDS/CMML.|Log Rank||HR:unadjusted stratified Cox proportional hazard regression with stratification factors(IPSS-R risk groups of very high,high,intermediate) and treatment as factor in model.HR\<1: longer survival time in combination arm than azacitidine arm.|Overall Survival in Participants who have TP53 Mutations, 17p Deletions, and/or are Determined to be in an Adverse Cytogenetic Risk Group||1.178|0.580|=0.145
72332813|NCT03268954|144190166|SUPERIORITY||Absolute Rate Difference|-5.14|||=|0.261|TWO_SIDED|95.0|-13.95|3.68||P-value was obtained from a stratified Cochran-Mantel-Haenszel chi-square test stratified by IPSS-R risk groups of very high, high, or intermediate for HR MDS/CMML.|Cochran-Mantel-Haenszel|||Overall Response for HR MDS/CMML||3.68|-13.95|=0.261
72332814|NCT03268954|144190166|SUPERIORITY||Absolute Rate Difference|22.36|||=|0.026|TWO_SIDED|95.0|3.22|41.49||P-value was obtained from an unstratified Cochran-Mantel-Haenszel chi-square test.|Cochran-Mantel-Haenszel|||Overall Response for Low-blast AML||41.49|3.22|=0.026
72332815|NCT02333396|144190167|SUPERIORITY||Beta Estimate|3.57|STANDARD_ERROR_OF_MEAN|4.53||0.44|TWO_SIDED|95.0|-5.77|12.9|||Mixed Models Analysis|||||12.9|-5.77|0.44
72332816|NCT02333396|144190168|SUPERIORITY||Beta Estimate|3.62|STANDARD_ERROR_OF_MEAN|2.05||0.09|TWO_SIDED|95.0|-0.61|7.84|||Mixed Models Analysis|||||7.84|-0.61|0.09
72332817|NCT02333396|144190169|SUPERIORITY||Beta Estimate|4.13|STANDARD_ERROR_OF_MEAN|2.05||0.05|TWO_SIDED|95.0|-0.09|8.36|||Mixed Models Analysis|||||8.36|-0.09|0.05
72332818|NCT02333396|144190170|SUPERIORITY||Beta Estimare|3.02|STANDARD_ERROR_OF_MEAN|2.26||0.19|TWO_SIDED|95.0|-1.63|7.67|||Mixed Models Analysis|||||7.67|-1.63|0.19
72332819|NCT02333396|144190171|SUPERIORITY||Beta Estimate|-0.22|STANDARD_ERROR_OF_MEAN|2.47||0.93|TWO_SIDED|95.0|-5.33|4.88|||Mixed Models Analysis|||||4.88|-5.33|0.93
72423532|NCT01216163|144357925|SUPERIORITY_OR_OTHER||LS mean difference|1.51|||<|0.001|TWO_SIDED|95.0|0.95|2.07||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||3 hours: Treatment difference (Acetaminophen - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||2.07|0.95|<0.001
72332820|NCT02333396|144190172|SUPERIORITY||Beta Estimate|-0.35|STANDARD_ERROR_OF_MEAN|1.29||0.79|TWO_SIDED|95.0|-3.02|2.31|||Mixed Models Analysis|||||2.31|-3.02|0.79
72332821|NCT02333396|144190175|SUPERIORITY||Beta Estimate|0.49|STANDARD_ERROR_OF_MEAN|1.03||0.64|TWO_SIDED|95.0|-2.62|1.64|||Mixed Models Analysis|||||1.64|-2.62|0.64
72332822|NCT02333396|144190176|SUPERIORITY||Beta Estimate|-0.9|STANDARD_ERROR_OF_MEAN|1.03||0.39|TWO_SIDED|95.0|-3.02|1.22|||Mixed Models Analysis|||||1.22|-3.02|0.39
72332823|NCT02333396|144190178|SUPERIORITY||Beta Estiamte|1.72|STANDARD_ERROR_OF_MEAN|1.1||0.13|TWO_SIDED|95.0|-0.55|3.98|||Mixed Models Analysis|||||3.98|-0.55|0.13
72332824|NCT02333396|144190179|SUPERIORITY||Beta Estimate|1.72|STANDARD_ERROR_OF_MEAN|1.1||0.13|TWO_SIDED|95.0|-0.55|3.98|||Mixed Models Analysis|||||3.98|-0.55|0.13
72423533|NCT01216163|144357925|SUPERIORITY_OR_OTHER||LS mean difference|1.97|||<|0.001|TWO_SIDED|95.0|1.39|2.56||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||4 hours: Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||2.56|1.39|<0.001
72423534|NCT01216163|144357925|SUPERIORITY_OR_OTHER||LS mean difference|0.63||||0.01|TWO_SIDED|95.0|0.15|1.1||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||4 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.10|0.15|0.010
72423535|NCT01216163|144357925|SUPERIORITY_OR_OTHER||LS mean difference|1.35|||<|0.001|TWO_SIDED|95.0|0.77|1.93||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||4 hours: Treatment difference (Acetaminophen - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.93|0.77|<0.001
72423536|NCT01216163|144357925|SUPERIORITY_OR_OTHER||LS mean difference|1.54|||<|0.001|TWO_SIDED|95.0|0.95|2.14||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||5 hours: Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||2.14|0.95|<0.001
72423537|NCT01216163|144357925|SUPERIORITY_OR_OTHER||LS mean difference|0.42||||0.088|TWO_SIDED|95.0|-0.06|0.91||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||5 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.91|-0.06|0.088
72423538|NCT01216163|144357925|SUPERIORITY_OR_OTHER||LS mean difference|1.12|||<|0.001|TWO_SIDED|95.0|0.52|1.71||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||5 hours: Treatment difference (Acetaminophen - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.71|0.52|<0.001
72423539|NCT01216163|144357925|SUPERIORITY_OR_OTHER||LS mean difference|1.46|||<|0.001|TWO_SIDED|95.0|0.85|2.07||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||6 hours: Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||2.07|0.85|<0.001
72423540|NCT01216163|144357925|SUPERIORITY_OR_OTHER||LS mean difference|0.47||||0.061|TWO_SIDED|95.0|-0.02|0.97||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||6 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.97|-0.02|0.061
72423541|NCT01216163|144357925|SUPERIORITY_OR_OTHER||LS mean difference|0.98||||0.002|TWO_SIDED|95.0|0.38|1.59||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||6 hours: Treatment difference (Acetaminophen - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.59|0.38|0.002
72423542|NCT01216163|144357926|SUPERIORITY_OR_OTHER||LS mean difference|0.31|||<|0.001|TWO_SIDED|95.0|0.13|0.49||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||0.25 hours: Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.49|0.13|<0.001
72423543|NCT01216163|144357926|SUPERIORITY_OR_OTHER||LS mean difference|0.06||||0.387|TWO_SIDED|95.0|-0.08|0.21||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||0.25 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.21|-0.08|0.387
72423544|NCT01216163|144357926|SUPERIORITY_OR_OTHER||LS mean difference|0.25||||0.007|TWO_SIDED|95.0|0.07|0.42||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||0.25 hours: Treatment difference (Acetaminophen - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.42|0.07|0.007
72423545|NCT01216163|144357926|SUPERIORITY_OR_OTHER||LS mean difference|0.89|||<|0.001|TWO_SIDED|95.0|0.64|1.15||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||0.5 hours: Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.15|0.64|<0.001
72423546|NCT01216163|144357926|SUPERIORITY_OR_OTHER||LS mean difference|0.25||||0.019|TWO_SIDED|95.0|0.04|0.46||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||0.5 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.46|0.04|0.019
72423547|NCT01216163|144357926|SUPERIORITY_OR_OTHER||LS mean difference|0.64|||<|0.001|TWO_SIDED|95.0|0.38|0.9||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||0.5 hours: Treatment difference (Acetaminophen - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.90|0.38|<0.001
72423548|NCT01216163|144357926|SUPERIORITY_OR_OTHER||LS mean difference|1.3|||<|0.001|TWO_SIDED|95.0|1.01|1.59||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1 hour: Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.59|1.01|<0.001
72423549|NCT01216163|144357926|SUPERIORITY_OR_OTHER||LS mean difference|0.33||||0.006|TWO_SIDED|95.0|0.09|0.57||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1 hour: Treatment difference (Ibuprofen sodium - Acetaminophen) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.57|0.09|0.006
72423550|NCT01216163|144357926|SUPERIORITY_OR_OTHER||LS mean difference|0.97|||<|0.001|TWO_SIDED|95.0|0.68|1.26||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1 hour: Treatment difference (Acetaminophen - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.26|0.68|<0.001
72423551|NCT01216163|144357926|SUPERIORITY_OR_OTHER||LS mean difference|1.43|||<|0.001|TWO_SIDED|95.0|1.12|1.74||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1.5 hours: Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.74|1.12|<0.001
72423552|NCT01216163|144357926|SUPERIORITY_OR_OTHER||LS mean difference|0.32||||0.014|TWO_SIDED|95.0|0.07|0.58||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1.5 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.58|0.07|0.014
72423553|NCT01216163|144357926|SUPERIORITY_OR_OTHER||LS mean difference|1.11|||<|0.001|TWO_SIDED|95.0|0.8|1.42||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1.5 hours: Treatment difference (Acetaminophen - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.42|0.80|<0.001
72423554|NCT01216163|144357926|SUPERIORITY_OR_OTHER||LS mean difference|1.43|||<|0.001|TWO_SIDED|95.0|1.09|1.78||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||2 hours: Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.78|1.09|<0.001
72423555|NCT01216163|144357926|SUPERIORITY_OR_OTHER||LS mean difference|0.31||||0.03|TWO_SIDED|95.0|0.03|0.59||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||2 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.59|0.03|0.030
72423556|NCT01216163|144357926|SUPERIORITY_OR_OTHER||LS mean difference|1.12|||<|0.001|TWO_SIDED|95.0|0.78|1.46||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||2 hours: Treatment difference (Acetaminophen - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.46|0.78|<0.001
72423557|NCT01216163|144357926|SUPERIORITY_OR_OTHER||LS mean difference|1.29|||<|0.001|TWO_SIDED|95.0|0.91|1.66||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||3 hours: Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.66|0.91|<0.001
72423558|NCT01216163|144357926|SUPERIORITY_OR_OTHER||LS mean difference|0.42||||0.007|TWO_SIDED|95.0|0.12|0.73||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||3 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.73|0.12|0.007
72423559|NCT01216163|144357926|SUPERIORITY_OR_OTHER||LS mean difference|0.87|||<|0.001|TWO_SIDED|95.0|0.49|1.24||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||3 hours: Treatment difference (Acetaminophen - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.24|0.49|<0.001
72423560|NCT01216163|144357926|SUPERIORITY_OR_OTHER||LS mean difference|1.27|||<|0.001|TWO_SIDED|95.0|0.89|1.65||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||4 hours: Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.65|0.89|<0.001
72423561|NCT01216163|144357926|SUPERIORITY_OR_OTHER||LS mean difference|0.45||||0.004|TWO_SIDED|95.0|0.15|0.76||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||4 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.76|0.15|0.004
72423562|NCT01216163|144357926|SUPERIORITY_OR_OTHER||LS mean difference|0.82|||<|0.001|TWO_SIDED|95.0|0.44|1.19||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||4 hours: Treatment difference (Acetaminophen - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.19|0.44|<0.001
72423563|NCT01216163|144357926|SUPERIORITY_OR_OTHER||LS mean difference|0.92|||<|0.001|TWO_SIDED|95.0|0.54|1.31||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||5 hours: Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.31|0.54|<0.001
72332825|NCT03802630|144190181|NON_INFERIORITY|Non-inferiority was considered established if the lower limit of the corresponding 95% CI for the estimated between group difference (brolucizumab vs. aflibercept) on change from baseline in BCVA at Week 24 is greater than -4 letters.|Least Square Mean Difference|-1.9|STANDARD_ERROR_OF_MEAN|1.01||0.018|TWO_SIDED|95.0|-3.9|0.1|||ANOVA|||||0.1|-3.9|0.018
72332826|NCT01108731|144190197|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||General Linear Model (GLM)|||||||<0.05
72332827|NCT01108731|144190198|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||General Linear Model (GLM)|||||||<0.05
72332828|NCT01108731|144190199|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<0.05
72332829|NCT01892722|144190204|SUPERIORITY||||||<|0.001|||||||Negative binomial regression model|||||||<0.001
72423564|NCT01216163|144357926|SUPERIORITY_OR_OTHER||LS mean difference|0.28||||0.084|TWO_SIDED|95.0|-0.04|0.59||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||5 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.59|-0.04|0.084
72423565|NCT01216163|144357926|SUPERIORITY_OR_OTHER||LS mean difference|0.65||||0.001|TWO_SIDED|95.0|0.27|1.03||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||5 hours: Treatment difference (Acetaminophen - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.03|0.27|0.001
72423566|NCT01216163|144357926|SUPERIORITY_OR_OTHER||LS mean difference|0.93|||<|0.001|TWO_SIDED|95.0|0.54|1.32||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||6 hours: Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.32|0.54|<0.001
72423567|NCT01216163|144357926|SUPERIORITY_OR_OTHER||LS mean difference|0.38||||0.02|TWO_SIDED|95.0|0.06|0.69||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||6 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.69|0.06|0.020
72332830|NCT01252186|144190211|NON_INFERIORITY_OR_EQUIVALENCE|A conclusion of non-inferiority was reached if the lower limit of the confidence interval for the comparison (active control minus 91-day Levonorgestrel) was greater than -0.13 nmol/L (130 pmol/L).|Treatment Difference|-11.54||||0.958|TWO_SIDED|95.0|-440.1|417.0|||Mixed Models Analysis||Treatment difference is calculated as (28-day Levonorgestrel - 91-day Levonorgestrel)|The primary endpoint was analyzed using a maximum likelihood-based mixed model repeated measures (MMRM) analysis of covariance (ANCOVA) with covariate adjustment for baseline, treatment, month, and the treatment-by-month interaction.||417.0|-440.1|0.958
72332831|NCT01252186|144190211|NON_INFERIORITY_OR_EQUIVALENCE|A conclusion of non-inferiority was reached if the lower limit of the confidence interval for the comparison (active control minus 91-day Levonorgestrel) was greater than -0.13 nmol/L (130 pmol/L).|Treatment Difference|422.76||||0.06|TWO_SIDED|95.0|-18.3|863.8|||Mixed Models Analysis||Treatment difference is calculated as (28-day Desogestrel - 91-day Levonorgestrel)|The primary endpoint was analyzed using a maximum likelihood-based mixed model repeated measures (MMRM) analysis of covariance (ANCOVA) with covariate adjustment for baseline, treatment, month, and the treatment-by-month interaction.||863.8|-18.3|0.060
72332832|NCT01252186|144190212|SUPERIORITY_OR_OTHER||Treatment Difference|-14.31||||0.745|TWO_SIDED|95.0|-100.8|72.2|||Mixed Models Analysis||Treatment difference is calculated as (28-day Levonorgestrel - 91-day Levonorgestrel)|The endpoint was analyzed using a maximum likelihood-based mixed model repeated measures (MMRM) analysis of covariance (ANCOVA) with covariate adjustment for baseline, treatment, month, and the treatment-by-month interaction.||72.2|-100.8|0.745
72332833|NCT01252186|144190212|SUPERIORITY_OR_OTHER||Treatment Difference|71.31||||0.115|TWO_SIDED|95.0|-17.5|160.1|||Mixed Models Analysis||Treatment difference is calculated as (28-day Desogestrel - 91-day Levonorgestrel)|The endpoint was analyzed using a maximum likelihood-based mixed model repeated measures (MMRM) analysis of covariance (ANCOVA) with covariate adjustment for baseline, treatment, month, and the treatment-by-month interaction.||160.1|-17.5|0.115
72332834|NCT01252186|144190213|SUPERIORITY_OR_OTHER||Treatment Difference|-17.14||||0.782|TWO_SIDED|95.0|-139.4|105.1|||Mixed Models Analysis||Treatment difference is calculated as (28-day Levonorgestrel - 91-day Levonorgestrel)|The endpoint was analyzed using a maximum likelihood-based mixed model repeated measures (MMRM) analysis of covariance (ANCOVA) with covariate adjustment for baseline, treatment, month, and the treatment-by-month interaction.||105.1|-139.4|0.782
72332835|NCT01252186|144190213|SUPERIORITY_OR_OTHER||Treatment Difference|97.09||||0.131|TWO_SIDED|95.0|-29.2|223.4|||Mixed Models Analysis||Treatment difference is calculated as (28-day Desogestrel - 91-day Levonorgestrel)|The endpoint was analyzed using a maximum likelihood-based mixed model repeated measures (MMRM) analysis of covariance (ANCOVA) with covariate adjustment for baseline, treatment, month, and the treatment-by-month interaction.||223.4|-29.2|0.131
72332836|NCT01252186|144190214|SUPERIORITY_OR_OTHER||Treatment Difference|-0.04||||0.428|TWO_SIDED|95.0|-0.1|0.1|||Mixed Models Analysis||Treatment difference is calculated as (28-day Levonorgestrel - 91-day Levonorgestrel)|The endpoint was analyzed using a maximum likelihood-based mixed model repeated measures (MMRM) analysis of covariance (ANCOVA) with covariate adjustment for baseline, treatment, month, and the treatment-by-month interaction.||0.1|-0.1|0.428
72332837|NCT01252186|144190214|SUPERIORITY_OR_OTHER||Treatment Difference|-0.16||||0.002|TWO_SIDED|95.0|-0.3|-0.1|||Mixed Models Analysis||Treatment difference is calculated as (28-day Desogestrel - 91-day Levonorgestrel)|The endpoint was analyzed using a maximum likelihood-based mixed model repeated measures (MMRM) analysis of covariance (ANCOVA) with covariate adjustment for baseline, treatment, month, and the treatment-by-month interaction.||-0.1|-0.3|0.002
72332838|NCT01252186|144190215|SUPERIORITY_OR_OTHER||Treatment Difference|-0.01||||0.868|TWO_SIDED|95.0|-0.2|0.1|||Mixed Models Analysis||Treatment difference is calculated as (28-day Levonorgestrel - 91-day Levonorgestrel)|The endpoint was analyzed using a maximum likelihood-based mixed model repeated measures (MMRM) analysis of covariance (ANCOVA) with covariate adjustment for baseline, treatment, month, and the treatment-by-month interaction.||0.1|-0.2|0.868
72332839|NCT01252186|144190215|SUPERIORITY_OR_OTHER||Treatment Difference|0.2||||0.012|TWO_SIDED|95.0|0.0|0.3|||Mixed Models Analysis||Treatment difference is calculated as (28-day Desogestrel - 91-day Levonorgestrel)|The endpoint was analyzed using a maximum likelihood-based mixed model repeated measures (MMRM) analysis of covariance (ANCOVA) with covariate adjustment for baseline, treatment, month, and the treatment-by-month interaction.||0.3|0.0|0.012
72332840|NCT01252186|144190216|SUPERIORITY_OR_OTHER||Treatment Difference|0.09||||0.317|TWO_SIDED|95.0|-0.1|0.3|||Mixed Models Analysis||Treatment difference is calculated as (28-day Levonorgestrel - 91-day Levonorgestrel)|The endpoint was analyzed using a maximum likelihood-based mixed model repeated measures (MMRM) analysis of covariance (ANCOVA) with covariate adjustment for baseline, treatment, month, and the treatment-by-month interaction.||0.3|-0.1|0.317
72423568|NCT01216163|144357926|SUPERIORITY_OR_OTHER||LS mean difference|0.56||||0.005|TWO_SIDED|95.0|0.17|0.94||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||6 hours: Treatment difference (Acetaminophen - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.94|0.17|0.005
72423569|NCT01216163|144357927|SUPERIORITY_OR_OTHER||LS mean difference|0.84|||<|0.001|TWO_SIDED|95.0|0.4|1.28||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||0.25 hours: Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.28|0.40|<0.001
72423570|NCT01216163|144357927|SUPERIORITY_OR_OTHER||LS mean difference|0.27||||0.148|TWO_SIDED|95.0|-0.1|0.63||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||0.25 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.63|-0.10|0.148
72332841|NCT01252186|144190216|SUPERIORITY_OR_OTHER||Treatment Difference|-0.16||||0.081|TWO_SIDED|95.0|-0.4|0.0|||Mixed Models Analysis||Treatment difference is calculated as (28-day Desogestrel - 91-day Levonorgestrel)|The endpoint was analyzed using a maximum likelihood-based mixed model repeated measures (MMRM) analysis of covariance (ANCOVA) with covariate adjustment for baseline, treatment, month, and the treatment-by-month interaction.||0.0|-0.4|0.081
72332842|NCT01252186|144190217|SUPERIORITY_OR_OTHER||Treatment Difference|-0.004||||0.331|TWO_SIDED|95.0|-0.013|0.004|||Mixed Models Analysis||Treatment difference is calculated as (28-day Levonorgestrel - 91-day Levonorgestrel)|The endpoint was analyzed using a maximum likelihood-based mixed model repeated measures (MMRM) analysis of covariance (ANCOVA) with covariate adjustment for baseline, treatment, month, and the treatment-by-month interaction.||0.004|-0.013|0.331
72332843|NCT01252186|144190217|SUPERIORITY_OR_OTHER||Treatment Difference|-0.006||||0.173|TWO_SIDED|95.0|-0.015|0.003|||Mixed Models Analysis||Treatment difference is calculated as (28-day Desogestrel - 91-day Levonorgestrel)|The endpoint was analyzed using a maximum likelihood-based mixed model repeated measures (MMRM) analysis of covariance (ANCOVA) with covariate adjustment for baseline, treatment, month, and the treatment-by-month interaction.||0.003|-0.015|0.173
72332844|NCT01252186|144190218|SUPERIORITY_OR_OTHER||Treatment Difference|-0.57||||0.194|TWO_SIDED|95.0|-1.4|0.3|||Mixed Models Analysis||Treatment difference is calculated as (28-day Levonorgestrel - 91-day Levonorgestrel)|The endpoint was analyzed using a maximum likelihood-based mixed model repeated measures (MMRM) analysis of covariance (ANCOVA) with covariate adjustment for baseline, treatment, month, and the treatment-by-month interaction.||0.3|-1.4|0.194
72332845|NCT01252186|144190218|SUPERIORITY_OR_OTHER||Treatment Difference|-0.02||||0.967|TWO_SIDED|95.0|-0.9|0.9|||Mixed Models Analysis||Treatment difference is calculated as (28-day Desogestrel - 91-day Levonorgestrel)|The endpoint was analyzed using a maximum likelihood-based mixed model repeated measures (MMRM) analysis of covariance (ANCOVA) with covariate adjustment for baseline, treatment, month, and the treatment-by-month interaction.||0.9|-0.9|0.967
72332846|NCT01252186|144190219|SUPERIORITY_OR_OTHER||Treatment Difference|1.09||||0.648|TWO_SIDED|95.0|-3.6|5.8|||Mixed Models Analysis||Treatment difference is calculated as (28-day Levonorgestrel - 91-day Levonorgestrel)|The endpoint was analyzed using a maximum likelihood-based mixed model repeated measures (MMRM) analysis of covariance (ANCOVA) with covariate adjustment for baseline, treatment, month, and the treatment-by-month interaction.||5.8|-3.6|0.648
72332847|NCT01252186|144190219|SUPERIORITY_OR_OTHER||Treatment Difference|1.68||||0.496|TWO_SIDED|95.0|-3.2|6.6|||Mixed Models Analysis||Treatment difference is calculated as (28-day Desogestrel - 91-day Levonorgestrel)|The endpoint was analyzed using a maximum likelihood-based mixed model repeated measures (MMRM) analysis of covariance (ANCOVA) with covariate adjustment for baseline, treatment, month, and the treatment-by-month interaction.||6.6|-3.2|0.496
72423571|NCT01216163|144357927|SUPERIORITY_OR_OTHER||LS mean difference|0.57||||0.011|TWO_SIDED|95.0|0.13|1.02||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||0.25 hours: Treatment difference (Acetaminophen - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.02|0.13|0.011
72423572|NCT01216163|144357927|SUPERIORITY_OR_OTHER||LS mean difference|2.34|||<|0.001|TWO_SIDED|95.0|1.68|2.99||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||0.5 hours: Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||2.99|1.68|<0.001
72332848|NCT01252186|144190220|SUPERIORITY_OR_OTHER||Treatment Difference|8.71||||0.405|TWO_SIDED|95.0|-11.9|29.3|||Mixed Models Analysis||Treatment difference is calculated as (28-day Levonorgestrel - 91-day Levonorgestrel)|The endpoint was analyzed using a maximum likelihood-based mixed model repeated measures (MMRM) analysis of covariance (ANCOVA) with covariate adjustment for baseline, treatment, month, and the treatment-by-month interaction.||29.3|-11.9|0.405
72423573|NCT01216163|144357927|SUPERIORITY_OR_OTHER||LS mean difference|0.49||||0.071|TWO_SIDED|95.0|-0.04|1.03||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||0.5 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.03|-0.04|0.071
72332849|NCT01252186|144190220|SUPERIORITY_OR_OTHER||Treatment Difference|28.95||||0.008|TWO_SIDED|95.0|7.7|50.2|||Mixed Models Analysis||Treatment difference is calculated as (28-day Desogestrel - 91-day Levonorgestrel)|The endpoint was analyzed using a maximum likelihood-based mixed model repeated measures (MMRM) analysis of covariance (ANCOVA) with covariate adjustment for baseline, treatment, month, and the treatment-by-month interaction.||50.2|7.7|0.008
72332850|NCT01252186|144190221|SUPERIORITY_OR_OTHER||Treatment Difference|3.3||||0.425|TWO_SIDED|195.0|-4.9|11.5|||Mixed Models Analysis||Treatment difference is calculated as (28-day Levonorgestrel - 91-day Levonorgestrel)|The endpoint was analyzed using a maximum likelihood-based mixed model repeated measures (MMRM) analysis of covariance (ANCOVA) with covariate adjustment for baseline, treatment, month, and the treatment-by-month interaction.||11.5|-4.9|0.425
72332851|NCT01252186|144190221|SUPERIORITY_OR_OTHER||Treatment Difference|8.76||||0.041|TWO_SIDED|95.0|0.3|17.2|||Mixed Models Analysis||Treatment difference is calculated as (28-day Desogestrel - 91-day Levonorgestrel)|The endpoint was analyzed using a maximum likelihood-based mixed model repeated measures (MMRM) analysis of covariance (ANCOVA) with covariate adjustment for baseline, treatment, month, and the treatment-by-month interaction.||17.2|0.3|0.041
72332852|NCT01252186|144190222|SUPERIORITY_OR_OTHER||Treatment Difference|-2.4||||0.088|TWO_SIDED|95.0|-5.2|0.4|||Mixed Models Analysis||Treatment difference is calculated as (28-day Levonorgestrel - 91-day Levonorgestrel)|The endpoint was analyzed using a maximum likelihood-based mixed model repeated measures (MMRM) analysis of covariance (ANCOVA) with covariate adjustment for baseline, treatment, month, and the treatment-by-month interaction.||0.4|-5.2|0.088
72332853|NCT01252186|144190222|SUPERIORITY_OR_OTHER||Treatment Difference|-3.19||||0.028|TWO_SIDED|95.0|-6.0|-0.3|||Mixed Models Analysis||Treatment difference is calculated as (28-day Desogestrel - 91-day Levonorgestrel)|The endpoint was analyzed using a maximum likelihood-based mixed model repeated measures (MMRM) analysis of covariance (ANCOVA) with covariate adjustment for baseline, treatment, month, and the treatment-by-month interaction.||-0.3|-6.0|0.028
72332854|NCT01252186|144190223|SUPERIORITY_OR_OTHER||Treatment Difference|1.75||||0.631|TWO_SIDED|95.0|-5.4|8.9|||Mixed Models Analysis||Treatment difference is calculated as (28-day Levonorgestrel - 91-day Levonorgestrel)|The endpoint was analyzed using a maximum likelihood-based mixed model repeated measures (MMRM) analysis of covariance (ANCOVA) with covariate adjustment for baseline, treatment, month, and the treatment-by-month interaction.||8.9|-5.4|0.631
72332855|NCT01252186|144190223|SUPERIORITY_OR_OTHER||Treatment Difference|3.73||||0.323|TWO_SIDED|95.0|-3.7|11.2|||Mixed Models Analysis||Treatment difference is calculated as (28-day Desogestrel - 91-day Levonorgestrel)|The endpoint was analyzed using a maximum likelihood-based mixed model repeated measures (MMRM) analysis of covariance (ANCOVA) with covariate adjustment for baseline, treatment, month, and the treatment-by-month interaction.||11.2|-3.7|0.323
72332856|NCT01252186|144190224|SUPERIORITY_OR_OTHER||Treatment Difference|-0.86||||0.783|TWO_SIDED|595.0|-7.0|5.3|||Mixed Models Analysis||Treatment difference is calculated as (28-day Levonorgestrel - 91-day Levonorgestrel)|The endpoint was analyzed using a maximum likelihood-based mixed model repeated measures (MMRM) analysis of covariance (ANCOVA) with covariate adjustment for baseline, treatment, month, and the treatment-by-month interaction.||5.3|-7.0|0.783
72332857|NCT01252186|144190224|SUPERIORITY_OR_OTHER||Treatment Difference|-2.83||||0.384|TWO_SIDED|95.0|-9.2|3.6|||Mixed Models Analysis||Treatment difference is calculated as (28-day Desogestrel - 91-day Levonorgestrel)|The endpoint was analyzed using a maximum likelihood-based mixed model repeated measures (MMRM) analysis of covariance (ANCOVA) with covariate adjustment for baseline, treatment, month, and the treatment-by-month interaction.||3.6|-9.2|0.384
72332858|NCT01252186|144190225|SUPERIORITY_OR_OTHER||Treatment Difference|1.66||||0.572|TWO_SIDED|95.0|-4.1|7.5|||Mixed Models Analysis||Treatment difference is calculated as (28-day Levonorgestrel - 91-day Levonorgestrel)|The endpoint was analyzed using a maximum likelihood-based mixed model repeated measures (MMRM) analysis of covariance (ANCOVA) with covariate adjustment for baseline, treatment, month, and the treatment-by-month interaction.||7.5|-4.1|0.572
72332859|NCT01252186|144190225|SUPERIORITY_OR_OTHER||Treatment Difference|-20.98|||<|0.001|TWO_SIDED|95.0|-27.0|-15.0|||Mixed Models Analysis||Treatment difference is calculated as (28-day Desogestrel - 91-day Levonorgestrel)|The endpoint was analyzed using a maximum likelihood-based mixed model repeated measures (MMRM) analysis of covariance (ANCOVA) with covariate adjustment for baseline, treatment, month, and the treatment-by-month interaction.||-15.0|-27.0|<0.001
72332860|NCT01252186|144190226|SUPERIORITY_OR_OTHER||Treatment Difference|-0.42||||0.841|TWO_SIDED|95.0|-4.6|3.7|||Mixed Models Analysis||Treatment difference is calculated as (28-day Levonorgestrel - 91-day Levonorgestrel)|The endpoint was analyzed using a maximum likelihood-based mixed model repeated measures (MMRM) analysis of covariance (ANCOVA) with covariate adjustment for baseline, treatment, month, and the treatment-by-month interaction.||3.7|-4.6|0.841
72332861|NCT01252186|144190226|SUPERIORITY_OR_OTHER||Treatment Difference|-10.53|||<|0.001|TWO_SIDED|95.0|-14.8|-6.3|||Mixed Models Analysis||Treatment difference is calculated as (28-day Desogestrel - 91-day Levonorgestrel)|The endpoint was analyzed using a maximum likelihood-based mixed model repeated measures (MMRM) analysis of covariance (ANCOVA) with covariate adjustment for baseline, treatment, month, and the treatment-by-month interaction.||-6.3|-14.8|<0.001
72332862|NCT01252186|144190227|SUPERIORITY_OR_OTHER||Treatment Difference|-2.11||||0.227|TWO_SIDED|95.0|-5.6|1.3|||Mixed Models Analysis||Treatment difference is calculated as (28-day Levonorgestrel - 91-day Levonorgestrel)|The endpoint was analyzed using a maximum likelihood-based mixed model repeated measures (MMRM) analysis of covariance (ANCOVA) with covariate adjustment for baseline, treatment, month, and the treatment-by-month interaction.||1.3|-5.6|0.227
72332863|NCT01252186|144190227|SUPERIORITY_OR_OTHER||Treatment Difference|-5.99||||0.001|TWO_SIDED|95.0|-9.6|-2.4|||Mixed Models Analysis||Treatment difference is calculated as (28-day Desogestrel - 91-day Levonorgestrel)|The endpoint was analyzed using a maximum likelihood-based mixed model repeated measures (MMRM) analysis of covariance (ANCOVA) with covariate adjustment for baseline, treatment, month, and the treatment-by-month interaction.||-2.4|-9.6|0.001
72332864|NCT01252186|144190228|SUPERIORITY_OR_OTHER||Treatment Difference|0.33||||0.076|TWO_SIDED|95.0|0.0|0.7|||Mixed Models Analysis||Treatment difference is calculated as (28-day Levonorgestrel - 91-day Levonorgestrel)|The endpoint was analyzed using a maximum likelihood-based mixed model repeated measures (MMRM) analysis of covariance (ANCOVA) with covariate adjustment for baseline, treatment, month, and the treatment-by-month interaction.||0.7|-0.0|0.076
72332865|NCT01252186|144190228|SUPERIORITY_OR_OTHER||Treatment Difference|0.44||||0.021|TWO_SIDED|95.0|0.1|0.8|||Mixed Models Analysis||Treatment difference is calculated as (28-day Desogestrel - 91-day Levonorgestrel)|The endpoint was analyzed using a maximum likelihood-based mixed model repeated measures (MMRM) analysis of covariance (ANCOVA) with covariate adjustment for baseline, treatment, month, and the treatment-by-month interaction.||0.8|0.1|0.021
72332866|NCT01252186|144190229|SUPERIORITY_OR_OTHER||Treatment Difference|44.46||||0.19|TWO_SIDED|95.0|-22.3|111.2|||Mixed Models Analysis||Treatment difference is calculated as (28-day Levonorgestrel - 91-day Levonorgestrel)|The endpoint was analyzed using a maximum likelihood-based mixed model repeated measures (MMRM) analysis of covariance (ANCOVA) with covariate adjustment for baseline, treatment, month, and the treatment-by-month interaction.||111.2|-22.3|0.190
72332867|NCT01252186|144190229|SUPERIORITY_OR_OTHER||Treatment Difference|9.74||||0.781|TWO_SIDED|95.0|-59.4|78.9|||Mixed Models Analysis||Treatment difference is calculated as (28-day Desogestrel - 91-day Levonorgestrel)|The endpoint was analyzed using a maximum likelihood-based mixed model repeated measures (MMRM) analysis of covariance (ANCOVA) with covariate adjustment for baseline, treatment, month, and the treatment-by-month interaction.||78.9|-59.4|0.781
72332868|NCT01252186|144190230|SUPERIORITY_OR_OTHER||Treatment Difference|-12.49||||0.843|TWO_SIDED|95.0|-136.4|111.4|||Mixed Models Analysis||Treatment difference is calculated as (28-day Levonorgestrel - 91-day Levonorgestrel)|The endpoint was analyzed using a maximum likelihood-based mixed model repeated measures (MMRM) analysis of covariance (ANCOVA) with covariate adjustment for baseline, treatment, month, and the treatment-by-month interaction.||111.4|-136.4|0.843
72423574|NCT01216163|144357927|SUPERIORITY_OR_OTHER||LS mean difference|1.84|||<|0.001|TWO_SIDED|95.0|1.19|2.5||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||0.5 hours: Treatment difference (Acetaminophen - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||2.50|1.19|<0.001
72423575|NCT01216163|144357927|SUPERIORITY_OR_OTHER||LS mean difference|3.37|||<|0.001|TWO_SIDED|95.0|2.67|4.06||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1 hour: Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||4.06|2.67|<0.001
72332869|NCT01252186|144190230|SUPERIORITY_OR_OTHER||Treatment Difference|58.3||||0.376|TWO_SIDED|95.0|-71.3|187.9|||Mixed Models Analysis||Treatment difference is calculated as (28-day Desogestrel - 91-day Levonorgestrel)|The endpoint was analyzed using a maximum likelihood-based mixed model repeated measures (MMRM) analysis of covariance (ANCOVA) with covariate adjustment for baseline, treatment, month, and the treatment-by-month interaction.||187.9|-71.3|0.376
72332870|NCT01252186|144190231|SUPERIORITY_OR_OTHER||Treatment Difference|-4.01||||0.731|TWO_SIDED|95.0|-27.0|19.0|||Mixed Models Analysis||Treatment difference is calculated as (28-day Levonorgestrel - 91-day Levonorgestrel)|The endpoint was analyzed using a maximum likelihood-based mixed model repeated measures (MMRM) analysis of covariance (ANCOVA) with covariate adjustment for baseline, treatment, month, and the treatment-by-month interaction.||19.0|-27.0|0.731
72332871|NCT01252186|144190231|SUPERIORITY_OR_OTHER||Treatment Difference|130.15|||<|0.001|TWO_SIDED|95.0|106.2|154.1|||Mixed Models Analysis||Treatment difference is calculated as (28-day Desogestrel - 91-day Levonorgestrel)|The endpoint was analyzed using a maximum likelihood-based mixed model repeated measures (MMRM) analysis of covariance (ANCOVA) with covariate adjustment for baseline, treatment, month, and the treatment-by-month interaction.||154.1|106.2|<0.001
72332872|NCT04283994|144190247|SUPERIORITY||Risk Difference (RD)|0.114||||0.023|TWO_SIDED|95.0|0.03|0.197||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.|Risk difference = clinician-facing intervention - usual care. Estimated via linear regression after adjusting for hospital site and dementia diagnosis. Confidence intervals using robust standard errors.|A total sample size of 600 (200 per arm) would give 80% power to detect a difference in proportions of 0.16 for each of the 3 pairwise comparisons assuming an overall 0.5 significance threshold, a Bonferroni adjustment for the 3 comparisons, and variance based on a proportion of 0.54.||0.197|0.030|0.023
72423576|NCT01216163|144357927|SUPERIORITY_OR_OTHER||LS mean difference|0.77||||0.008|TWO_SIDED|95.0|0.2|1.33||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1 hour: Treatment difference (Ibuprofen sodium - Acetaminophen) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.33|0.20|0.008
72332873|NCT04283994|144190247|SUPERIORITY||Risk Difference (RD)|0.068||||0.294|TWO_SIDED|95.0|-0.013|0.15||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.|Risk difference = bidirectional intervention - usual care. Estimated via linear regression after adjusting for hospital site and dementia diagnosis. Confidence intervals using robust standard errors.|A total sample size of 600 (200 per arm) would give 80% power to detect a difference in proportions of 0.16 for each of the 3 pairwise comparisons assuming an overall 0.5 significance threshold, a Bonferroni adjustment for the 3 comparisons, and variance based on a proportion of 0.54.||0.150|-0.013|0.294
72423577|NCT01216163|144357927|SUPERIORITY_OR_OTHER||LS mean difference|2.6|||<|0.001|TWO_SIDED|95.0|1.91|3.3||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1 hour: Treatment difference (Acetaminophen - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||3.30|1.91|<0.001
72332874|NCT04283994|144190247|SUPERIORITY||Risk Difference (RD)|-0.045||||0.952|TWO_SIDED|95.0|-0.134|0.044||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.|Risk difference = bidirectional intervention - clinician-facing intervention. Estimated via linear regression after adjusting for hospital site and dementia diagnosis. Confidence intervals using robust standard errors.|A total sample size of 600 (200 per arm) would give 80% power to detect a difference in proportions of 0.16 for each of the 3 pairwise comparisons assuming an overall 0.5 significance threshold, a Bonferroni adjustment for the 3 comparisons, and variance based on a proportion of 0.54.||0.044|-0.134|0.952
72423578|NCT01216163|144357927|SUPERIORITY_OR_OTHER||LS mean difference|3.68|||<|0.001|TWO_SIDED|95.0|2.92|4.43||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1.5 hours: Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||4.43|2.92|<0.001
72423579|NCT01216163|144357927|SUPERIORITY_OR_OTHER||LS mean difference|0.69||||0.028|TWO_SIDED|95.0|0.07|1.3||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1.5 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.30|0.07|0.028
72423580|NCT01216163|144357927|SUPERIORITY_OR_OTHER||LS mean difference|2.99|||<|0.001|TWO_SIDED|95.0|2.24|3.74||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1.5 hours: Treatment difference (Acetaminophen - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||3.74|2.24|<0.001
72423581|NCT01216163|144357927|SUPERIORITY_OR_OTHER||LS mean difference|3.75|||<|0.001|TWO_SIDED|95.0|2.9|4.59||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||2 hours: Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||4.59|2.90|<0.001
72423582|NCT01216163|144357927|SUPERIORITY_OR_OTHER||LS mean difference|0.82||||0.02|TWO_SIDED|95.0|0.13|1.51||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||2 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.51|0.13|0.020
72423583|NCT01216163|144357927|SUPERIORITY_OR_OTHER||LS mean difference|2.93|||<|0.001|TWO_SIDED|95.0|2.09|3.77||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||2 hours: Treatment difference (Acetaminophen - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||3.77|2.09|<0.001
72423584|NCT01216163|144357927|SUPERIORITY_OR_OTHER||LS mean difference|3.38|||<|0.001|TWO_SIDED|95.0|2.46|4.3||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||3 hours: Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||4.30|2.46|<0.001
72423585|NCT01216163|144357927|SUPERIORITY_OR_OTHER||LS mean difference|1.01||||0.009|TWO_SIDED|95.0|0.26|1.76||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||3 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.76|0.26|0.009
72423586|NCT01216163|144357927|SUPERIORITY_OR_OTHER||LS mean difference|2.38|||<|0.001|TWO_SIDED|95.0|1.46|3.3||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||3 hours: Treatment difference (Acetaminophen - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||3.30|1.46|<0.001
72423587|NCT01216163|144357927|SUPERIORITY_OR_OTHER||LS mean difference|3.24|||<|0.001|TWO_SIDED|95.0|2.3|4.19||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||4 hours: Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||4.19|2.30|<0.001
72423588|NCT01216163|144357927|SUPERIORITY_OR_OTHER||LS mean difference|1.08||||0.006|TWO_SIDED|95.0|0.31|1.85||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||4 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.85|0.31|0.006
72423589|NCT01216163|144357927|SUPERIORITY_OR_OTHER||LS mean difference|2.16|||<|0.001|TWO_SIDED|95.0|1.22|3.1||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||4 hours: Treatment difference (Acetaminophen - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||3.10|1.22|<0.001
72423590|NCT01216163|144357927|SUPERIORITY_OR_OTHER||LS mean difference|2.47|||<|0.001|TWO_SIDED|95.0|1.51|3.43||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||5 hours: Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||3.43|1.51|<0.001
72423591|NCT01216163|144357927|SUPERIORITY_OR_OTHER||LS mean difference|0.7||||0.08|TWO_SIDED|95.0|-0.09|1.49||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||5 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.49|-0.09|0.080
72423592|NCT01216163|144357927|SUPERIORITY_OR_OTHER||LS mean difference|1.77|||<|0.001|TWO_SIDED|95.0|0.81|2.73||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||5 hours: Treatment difference (Acetaminophen - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||2.73|0.81|<0.001
72332875|NCT04283994|144190254|SUPERIORITY||Mean Difference (Final Values)|-0.3||||1.65|TWO_SIDED|95.0|-1.3|0.7||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis|Mean difference = bi-directional intervention - usual care. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.|||0.7|-1.3|1.650
72332876|NCT04283994|144190254|SUPERIORITY||Mean Difference (Final Values)|-0.5||||0.985|TWO_SIDED|95.0|-1.6|0.5||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.|Mean difference = clinician-facing intervention - usual care. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.|||0.5|-1.6|0.985
72423593|NCT01216163|144357927|SUPERIORITY_OR_OTHER||LS mean difference|2.39|||<|0.001|TWO_SIDED|95.0|1.41|3.37||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||6 hours: Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||3.37|1.41|<0.001
72423594|NCT01216163|144357927|SUPERIORITY_OR_OTHER||LS mean difference|0.85||||0.037|TWO_SIDED|95.0|0.05|1.65||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||6 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.65|0.05|0.037
72332877|NCT04283994|144190254|SUPERIORITY||Mean Difference (Final Values)|0.2||||2.155|TWO_SIDED|95.0|-1.0|1.4||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.|Mean difference = bi-directional intervention - clinician-facing intervention. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.|||1.4|-1.0|2.155
72332878|NCT04283994|144190255|SUPERIORITY||Mean Difference (Final Values)|0.7||||2.169|TWO_SIDED|95.0|-3.1|4.4||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis,|Mean difference = bi-directional intervention - usual care. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.|||4.4|-3.1|2.169
72423595|NCT01216163|144357927|SUPERIORITY_OR_OTHER||LS mean difference|1.54||||0.002|TWO_SIDED|95.0|0.57|2.52||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||6 hours: Treatment difference (Acetaminophen - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||2.52|0.57|0.002
72423596|NCT01216163|144357928|SUPERIORITY_OR_OTHER||LS mean difference|2.38|||<|0.001|TWO_SIDED|95.0|1.88|2.88||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPID 0-2: Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||2.88|1.88|<0.001
72332879|NCT04283994|144190255|SUPERIORITY||Mean Difference (Final Values)|-3.3||||0.391|TWO_SIDED|95.0|-7.5|1.0||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.|Mean difference = clinician-facing intervention - usual care. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.|||1.0|-7.5|0.391
72332880|NCT04283994|144190255|SUPERIORITY||Mean Difference (Final Values)|4.0||||0.21|TWO_SIDED|95.0|-0.3|8.2||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.|Mean difference = bi-directional intervention - clinician-facing intervention. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.|||8.2|-0.3|0.210
72423597|NCT01216163|144357928|SUPERIORITY_OR_OTHER||LS mean difference|0.56||||0.007|TWO_SIDED|95.0|0.15|0.97||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPID 0-2: Treatment difference (Ibuprofen sodium - Acetaminophen) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.97|0.15|0.007
72423598|NCT01216163|144357928|SUPERIORITY_OR_OTHER||LS mean difference|1.82|||<|0.001|TWO_SIDED|95.0|1.32|2.32||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPID 0-2: Treatment difference (Acetaminophen - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||2.32|1.32|<0.001
72332881|NCT04283994|144190256|SUPERIORITY||Mean Difference (Final Values)|0.8||||1.01|TWO_SIDED|95.0|-0.8|2.4||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.|Mean difference = bi-directional intervention - usual care. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.|||2.4|-0.8|1.010
72423599|NCT01216163|144357928|SUPERIORITY_OR_OTHER||LS mean difference|3.67|||<|0.001|TWO_SIDED|95.0|2.85|4.49||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPID 0-3: Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||4.49|2.85|<0.001
72423600|NCT01216163|144357928|SUPERIORITY_OR_OTHER||LS mean difference|0.98||||0.004|TWO_SIDED|95.0|0.31|1.66||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPID 0-3: Treatment difference (Ibuprofen sodium - Acetaminophen) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.66|0.31|0.004
72423601|NCT01216163|144357928|SUPERIORITY_OR_OTHER||LS mean difference|2.69|||<|0.001|TWO_SIDED|95.0|1.87|3.51||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPID 0-3: Treatment difference (Acetaminophen - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||3.51|1.87|<0.001
72423602|NCT01216163|144357928|SUPERIORITY_OR_OTHER||LS mean difference|6.8|||<|0.001|TWO_SIDED|95.0|4.96|8.64||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPID 0-6: Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||8.64|4.96|<0.001
72332882|NCT04283994|144190256|SUPERIORITY||Mean Difference (Final Values)|0.0||||2.923|TWO_SIDED|95.0|-1.7|1.7||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.|Mean difference = clinician-facing intervention - usual care. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.|||1.7|-1.7|2.923
72332883|NCT04283994|144190256|SUPERIORITY||Mean Difference (Final Values)|0.8||||1.034|TWO_SIDED|95.0|-0.9|2.5||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.|Mean difference = bi-directional intervention - clinician-facing intervention. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.|||2.5|-0.9|1.034
72332884|NCT04283994|144190257|SUPERIORITY||Mean Difference (Final Values)|3.5||||0.384|TWO_SIDED|95.0|-1.0|7.9||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.|Mean difference = bi-directional intervention - usual care. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.|||7.9|-1.0|0.384
72423603|NCT01216163|144357928|SUPERIORITY_OR_OTHER||LS mean difference|2.09||||0.007|TWO_SIDED|95.0|0.59|3.59||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPID 0-6: Treatment difference (Ibuprofen sodium - Acetaminophen) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||3.59|0.59|0.007
72423604|NCT01216163|144357928|SUPERIORITY_OR_OTHER||LS mean difference|4.71|||<|0.001|TWO_SIDED|95.0|2.87|6.54||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPID 0-6: Treatment difference (Acetaminophen - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||6.54|2.87|<0.001
72332885|NCT04283994|144190257|SUPERIORITY||Mean Difference (Final Values)|-1.2||||1.923|TWO_SIDED|95.0|-6.1|3.7||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.|Mean difference = clinician-facing intervention - usual care. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.|||3.7|-6.1|1.923
72332886|NCT04283994|144190257|SUPERIORITY||Mean Difference (Final Values)|4.6||||0.166|TWO_SIDED|95.0|-0.1|9.4||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.|Mean difference = bi-directional intervention - clinician-facing intervention. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.|||9.4|-0.1|0.166
72332887|NCT04283994|144190258|SUPERIORITY||Risk Difference (RD)|-0.11||||0.16|TWO_SIDED|95.0|-0.23|0.0||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.|Risk difference = bi-directional intervention - usual care. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.|"Complete case analysis. Unsure responses counted as non-events."||0.00|-0.23|0.160
72332888|NCT04283994|144190258|SUPERIORITY||Risk Difference (RD)|-0.07||||0.652|TWO_SIDED|95.0|-0.18|0.04||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.|Risk difference = clinician-facing intervention - usual care. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.|"Complete case analysis. Unsure responses counted as non-events."||0.04|-0.18|0.652
72332889|NCT04283994|144190258|SUPERIORITY||Risk Difference (RD)|-0.04||||1.39|TWO_SIDED|95.0|-0.16|0.07||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.|Risk difference = bi-directional intervention - clinician-facing intervention. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.|"Complete case analysis. Unsure responses counted as non-events."||0.07|-0.16|1.390
72332890|NCT04283994|144190259|SUPERIORITY||Risk Difference (RD)|0.05||||1.192|TWO_SIDED|95.0|-0.06|0.16||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.|Risk difference = bi-directional intervention - usual care. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.|"Complete case analysis. Unsure responses counted as non-events."||0.16|-0.06|1.192
72332891|NCT04283994|144190259|SUPERIORITY||Risk Difference (RD)|0.01||||2.698|TWO_SIDED|95.0|-0.11|0.12||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.|Risk difference = clinician-facing intervention - usual care. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.|"Complete case analysis. Unsure responses counted as non-events."||0.12|-0.11|2.698
72332892|NCT04283994|144190259|SUPERIORITY||Risk Difference (RD)|0.04||||1.477|TWO_SIDED|95.0|-0.08|0.16||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.|Risk difference = bi-directional intervention - clinician-facing intervention. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.|"Complete case analysis. Unsure responses counted as non-events."||0.16|-0.08|1.477
72332893|NCT04283994|144190260|SUPERIORITY||Mean Difference (Final Values)|-0.57||||2.293|TWO_SIDED|95.0|-4.3|3.16||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.|Mean difference = bi-directional intervention - usual care. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.|Complete case analysis.||3.16|-4.30|2.293
72423605|NCT01216163|144357929|SUPERIORITY_OR_OTHER||LS mean difference|3.81|||<|0.001|TWO_SIDED|95.0|3.05|4.57||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||TOTPAR 0-2: Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||4.57|3.05|<0.001
72332894|NCT04283994|144190260|SUPERIORITY||Mean Difference (Final Values)|-0.48||||2.381|TWO_SIDED|95.0|-4.11|3.14||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.|Mean difference = clinician-facing intervention - usual care. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.|||3.14|-4.11|2.381
72332895|NCT04283994|144190260|SUPERIORITY||Mean Difference (Final Values)|-0.09||||2.893|TWO_SIDED|95.0|-3.86|3.69||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.|Mean difference = bi-directional intervention - clinician-facing intervention. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.|||3.69|-3.86|2.893
72332896|NCT04283994|144190261|SUPERIORITY||Risk Difference (RD)|0.0||||2.829|TWO_SIDED|95.0|-0.13|0.12||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.|Risk difference = bi-directional intervention - usual care. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.|"Complete case analysis. Unsure responses counted as non-events."||0.12|-0.13|2.829
72332897|NCT04283994|144190261|SUPERIORITY||Risk Difference (RD)|0.11||||0.188|TWO_SIDED|95.0|-0.01|0.24||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.|Risk difference = clinician-facing intervention - usual care. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.|"Complete case analysis. Unsure responses counted as non-events."||0.24|-0.01|0.188
72332898|NCT04283994|144190261|SUPERIORITY||Risk Difference (RD)|-0.12||||0.19|TWO_SIDED|95.0|-0.24|0.01||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.|Risk difference = bi-directional intervention - clinician-facing intervention. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.|"Complete case analysis. Unsure responses counted as non-events."||0.01|-0.24|0.190
72332899|NCT04283994|144190262|SUPERIORITY||Risk Difference (RD)|0.03||||1.994|TWO_SIDED|95.0|-0.09|0.14||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.|Risk difference = bi-directional intervention - usual care. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.|"Complete case analysis. Unsure responses counted as non-events."||0.14|-0.09|1.994
72332900|NCT04283994|144190262|SUPERIORITY||Risk Difference (RD)|0.07||||0.771|TWO_SIDED|95.0|-0.05|0.19||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.|Risk difference = clinician-facing intervention - usual care. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.|"Complete case analysis. Unsure responses counted as non-events."||0.19|-0.05|0.771
72332901|NCT04283994|144190262|SUPERIORITY||Risk Difference (RD)|-0.04||||1.447|TWO_SIDED|95.0|-0.17|0.08||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.|Risk difference = bi-directional intervention - clinician-facing intervention. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.|"Complete case analysis. Unsure responses counted as non-events."||0.08|-0.17|1.447
72423606|NCT01216163|144357929|SUPERIORITY_OR_OTHER||LS mean difference|0.76||||0.016|TWO_SIDED|95.0|0.14|1.38||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||TOTPAR 0-2: Treatment difference (Ibuprofen sodium - Acetaminophen) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.38|0.14|0.016
72423607|NCT01216163|144357929|SUPERIORITY_OR_OTHER||LS mean difference|3.04|||<|0.001|TWO_SIDED|95.0|2.29|3.8||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||TOTPAR 0-2: Treatment difference (Acetaminophen - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||3.80|2.29|<0.001
72332902|NCT04283994|144190265|SUPERIORITY||Risk Difference (RD)|-0.012||||1.836|TWO_SIDED|95.0|-0.058|0.034||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.|Risk difference = bi-directional intervention - usual care. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.|||0.034|-0.058|1.836
72423608|NCT01216163|144357929|SUPERIORITY_OR_OTHER||LS mean difference|5.9|||<|0.001|TWO_SIDED|95.0|4.66|7.15||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||TOTPAR 0-3: Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||7.15|4.66|<0.001
72423609|NCT01216163|144357929|SUPERIORITY_OR_OTHER||LS mean difference|1.35||||0.01|TWO_SIDED|95.0|0.33|2.37||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||TOTPAR 0-3: Treatment difference (Ibuprofen sodium - Acetaminophen) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||2.37|0.33|0.010
72423610|NCT01216163|144357929|SUPERIORITY_OR_OTHER||LS mean difference|4.56|||<|0.001|TWO_SIDED|95.0|3.31|5.8||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||TOTPAR 0-3: Treatment difference (Acetaminophen - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||5.80|3.31|<0.001
72423611|NCT01216163|144357929|SUPERIORITY_OR_OTHER||LS mean difference|10.88|||<|0.001|TWO_SIDED|95.0|8.05|13.7||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||TOTPAR 0-6: Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||13.70|8.05|<0.001
72423612|NCT01216163|144357929|SUPERIORITY_OR_OTHER||LS mean difference|2.87||||0.015|TWO_SIDED|95.0|0.57|5.18||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||TOTPAR 0-6: Treatment difference (Ibuprofen sodium - Acetaminophen) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||5.18|0.57|0.015
72332903|NCT04283994|144190265|SUPERIORITY||Risk Difference (RD)|0.021||||1.25|TWO_SIDED|95.0|-0.03|0.073||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.|Risk difference = clinician-facing intervention - usual care. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.|||0.073|-0.030|1.250
72332904|NCT04283994|144190265|SUPERIORITY||Risk Difference (RD)|-0.033||||0.581|TWO_SIDED|95.0|-0.084|0.017||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.|Risk difference = bi-directional intervention - clinician-facing intervention. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.|||0.017|-0.084|0.581
72332905|NCT04283994|144190266|SUPERIORITY||Risk Difference (RD)|-0.039||||0.692|TWO_SIDED|95.0|-0.102|0.025||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.|Risk difference = bi-directional intervention - usual care. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.|||0.025|-0.102|0.692
72423613|NCT01216163|144357929|SUPERIORITY_OR_OTHER||LS mean difference|8.0|||<|0.001|TWO_SIDED|95.0|5.18|10.83||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||TOTPAR 0-6: Treatment difference (Acetaminophen - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||10.83|5.18|<0.001
72423614|NCT01216163|144357930|SUPERIORITY_OR_OTHER||LS mean difference|6.19|||<|0.001|TWO_SIDED|95.0|4.96|7.43||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPRID 0-2: Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||7.43|4.96|<0.001
72423615|NCT01216163|144357930|SUPERIORITY_OR_OTHER||LS mean difference|1.33||||0.01|TWO_SIDED|95.0|0.32|2.33||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPRID 0-2: Treatment difference (Ibuprofen sodium - Acetaminophen) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||2.33|0.32|0.010
72423616|NCT01216163|144357930|SUPERIORITY_OR_OTHER||LS mean difference|4.87|||<|0.001|TWO_SIDED|95.0|3.63|6.1||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPRID 0-2: Treatment difference (Acetaminophen - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||6.10|3.63|<0.001
72423617|NCT01216163|144357930|SUPERIORITY_OR_OTHER||LS mean difference|9.58|||<|0.001|TWO_SIDED|95.0|7.54|11.61||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPRID 0-3: Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||11.61|7.54|<0.001
72423618|NCT01216163|144357930|SUPERIORITY_OR_OTHER||LS mean difference|2.33||||0.006|TWO_SIDED|95.0|0.67|4.0||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPRID 0-3: Treatment difference (Ibuprofen sodium - Acetaminophen) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||4.00|0.67|0.006
72423619|NCT01216163|144357930|SUPERIORITY_OR_OTHER||LS mean difference|7.24|||<|0.001|TWO_SIDED|95.0|5.21|9.28||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPRID 0-3: Treatment difference (Acetaminophen - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||9.28|5.21|<0.001
72423620|NCT01216163|144357931|SUPERIORITY_OR_OTHER||Difference in proportion|21.42|||<|0.001|TWO_SIDED|95.0|12.99|29.84||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||0.5 hours: Treatment difference (Ibuprofen sodium - Placebo) and its associated CI was calculated based on Cochran-Mantel-Haenszel (CMH) adjusted proportions and the corresponding standard error.||29.84|12.99|<0.001
72423621|NCT01216163|144357931|SUPERIORITY_OR_OTHER||Difference in proportion|1.58||||0.799|TWO_SIDED|95.0|-10.54|13.7||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||0.5 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||13.70|-10.54|0.799
72423622|NCT01216163|144357931|SUPERIORITY_OR_OTHER||Difference in proportion|20.09||||0.001|TWO_SIDED|95.0|11.45|28.72||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||0.5 hours: Treatment difference (Acetaminophen - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||28.72|11.45|0.001
72423623|NCT01216163|144357931|SUPERIORITY_OR_OTHER||Difference in proportion|53.22|||<|0.001|TWO_SIDED|95.0|42.92|63.53||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1 hour: Treatment difference (Ibuprofen sodium - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||63.53|42.92|<0.001
72423624|NCT01216163|144357931|SUPERIORITY_OR_OTHER||Difference in proportion|-2.98||||0.695|TWO_SIDED|95.0|-17.67|11.7||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1 hour: Treatment difference (Ibuprofen sodium - Acetaminophen) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||11.70|-17.67|0.695
72423625|NCT01216163|144357931|SUPERIORITY_OR_OTHER||Difference in proportion|57.06|||<|0.001|TWO_SIDED|95.0|46.53|67.6||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1 hour: Treatment difference (Acetaminophen - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||67.60|46.53|<0.001
72423626|NCT01216163|144357931|SUPERIORITY_OR_OTHER||Difference in proportion|70.58|||<|0.001|TWO_SIDED|95.0|60.28|80.88||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1.5 hours: Treatment difference (Ibuprofen sodium - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||80.88|60.28|<0.001
72332906|NCT04283994|144190266|SUPERIORITY||Risk Difference (RD)|0.038||||0.887|TWO_SIDED|95.0|-0.033|0.109||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.|Risk difference = clinician-facing intervention - usual care. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.|||0.109|-0.033|0.887
72332907|NCT04283994|144190266|SUPERIORITY||Risk Difference (RD)|-0.077||||0.08|TWO_SIDED|95.0|-0.145|-0.009||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.|Risk difference = bi-directional intervention - clinician-facing intervention. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.|||-0.009|-0.145|0.080
72332908|NCT04283994|144190267|SUPERIORITY||Hazard Ratio (HR)|1.4||||0.293|TWO_SIDED|95.0|0.9|2.1||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Cox|Wald test adjusting for hospital site and dementia diagnosis.|Hazard ratio = bi-directional intervention / usual care. Estimated via cox proportional hazards regression after adjusting for hospital and dementia diagnosis. Exponentiated Wald confidence intervals.|Censoring by death.||2.1|0.9|0.293
72332909|NCT04283994|144190267|SUPERIORITY||Hazard Ratio (HR)|1.7||||0.027|TWO_SIDED|95.0|1.1|2.5||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Cox|Wald test adjusting for hospital site and dementia diagnosis|Hazard ratio = clinician-facing intervention / usual care. Estimated via cox proportional hazards regression after adjusting for hospital and dementia diagnosis. Exponentiated Wald confidence intervals.|Censoring by death.||2.5|1.1|0.027
72332910|NCT04283994|144190267|SUPERIORITY||Hazard Ratio (HR)|0.8||||1.009|TWO_SIDED|95.0|0.6|1.2||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Cox|Wald test adjusting for hospital site and dementia diagnosis.|Hazard ratio = bi-directional intervention / clinician-facing intervention. Estimated via cox proportional hazards regression after adjusting for hospital and dementia diagnosis. Exponentiated Wald confidence intervals.|Censoring by death.||1.2|0.6|1.009
72332911|NCT04283994|144190268|SUPERIORITY||Mean Difference (Final Values)|-0.43||||1.366|TWO_SIDED|95.0|-1.55|0.7||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.|Mean difference = bi-directional intervention - usual care. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.|Complete case analysis.||0.70|-1.55|1.366
72332912|NCT04283994|144190268|SUPERIORITY||Mean Difference (Final Values)|-0.58||||0.978|TWO_SIDED|95.0|-1.73|0.58||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.|Mean difference = clinician-facing intervention - usual care. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.|Complete case analysis.||0.58|-1.73|0.978
72332913|NCT04283994|144190268|SUPERIORITY||Mean Difference (Final Values)|0.15||||2.39|TWO_SIDED|95.0|-0.99|1.3||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.|Mean difference = bi-directional intervention - clinician-facing intervention. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.|Complete case analysis.||1.30|-0.99|2.390
72332914|NCT04283994|144190269|SUPERIORITY||Mean Difference (Final Values)|0.47||||1.125|TWO_SIDED|95.0|-0.57|1.51||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.|Mean difference = bi-directional intervention - usual care. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.|Complete case analysis.||1.51|-0.57|1.125
72332915|NCT04283994|144190269|SUPERIORITY||Mean Difference (Final Values)|0.91||||0.258|TWO_SIDED|95.0|-0.13|1.94||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.|Mean difference = clinician-facing intervention - usual care. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.|Complete case analysis.||1.94|-0.13|0.258
72332916|NCT04283994|144190269|SUPERIORITY||Mean Difference (Final Values)|-0.44||||1.267|TWO_SIDED|95.0|-1.5|0.63||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.|Mean difference = bi-directional intervention - clinician-facing intervention. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.|Complete case analysis.||0.63|-1.5|1.267
72332917|NCT04283994|144190270|SUPERIORITY||Mean Difference (Final Values)|0.32||||1.594|TWO_SIDED|95.0|-0.68|1.32||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.|Mean difference = bi-directional intervention - usual care. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.|Complete case analysis.||1.32|-0.68|1.594
72332918|NCT04283994|144190270|SUPERIORITY||Mean Difference (Final Values)|0.29||||1.803|TWO_SIDED|95.0|-0.79|1.36||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.|Mean difference = clinician-facing intervention - usual care. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.|Complete case analysis.||1.36|-0.79|1.803
72423627|NCT01216163|144357931|SUPERIORITY_OR_OTHER||Difference in proportion|7.99||||0.261|TWO_SIDED|95.0|-5.85|21.84||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1.5 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||21.84|-5.85|0.261
72423628|NCT01216163|144357931|SUPERIORITY_OR_OTHER||Difference in proportion|62.88|||<|0.001|TWO_SIDED|95.0|51.78|73.99||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1.5 hours: Treatment difference (Acetaminophen - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||73.99|51.78|<0.001
72423629|NCT01216163|144357931|SUPERIORITY_OR_OTHER||Difference in proportion|66.24|||<|0.001|TWO_SIDED|95.0|53.77|78.71||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||2 hours: Treatment difference (Ibuprofen sodium - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||78.71|53.77|<0.001
72423630|NCT01216163|144357931|SUPERIORITY_OR_OTHER||Difference in proportion|4.38||||0.522|TWO_SIDED|95.0|-8.89|17.64||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||2 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||17.64|-8.89|0.522
72423631|NCT01216163|144357931|SUPERIORITY_OR_OTHER||Difference in proportion|61.93|||<|0.001|TWO_SIDED|95.0|49.06|74.8||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||2 hours: Treatment difference (Acetaminophen - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||74.80|49.06|<0.001
72423632|NCT01216163|144357931|SUPERIORITY_OR_OTHER||Difference in proportion|66.35|||<|0.001|TWO_SIDED|95.0|53.61|79.09||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||3 hours: Treatment difference (Ibuprofen sodium - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||79.09|53.61|<0.001
72423633|NCT01216163|144357931|SUPERIORITY_OR_OTHER||Difference in proportion|5.46||||0.415|TWO_SIDED|95.0|-7.53|18.44||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||3 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||18.44|-7.53|0.415
72423634|NCT01216163|144357931|SUPERIORITY_OR_OTHER||Difference in proportion|60.92|||<|0.001|TWO_SIDED|95.0|47.65|74.19||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||3 hours: Treatment difference (Acetaminophen - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||74.19|47.65|<0.001
72332919|NCT04283994|144190270|SUPERIORITY||Mean Difference (Final Values)|0.03||||2.851|TWO_SIDED|95.0|-1.01|1.07||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.|Mean difference = bi-directional intervention - clinician-facing intervention. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.|Complete case analysis.||1.07|-1.01|2.851
72332920|NCT04283994|144190271|SUPERIORITY||Mean Difference (Final Values)|-0.28||||1.243|TWO_SIDED|95.0|-0.97|0.4||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.|Mean difference = bi-directional intervention - usual care. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.|Complete case analysis.||0.40|-0.97|1.243
72423635|NCT01216163|144357931|SUPERIORITY_OR_OTHER||Difference in proportion|65.32|||<|0.001|TWO_SIDED|95.0|52.18|78.46||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||4 hours: Treatment difference (Ibuprofen sodium - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||78.46|52.18|<0.001
72423636|NCT01216163|144357931|SUPERIORITY_OR_OTHER||Difference in proportion|4.21||||0.519|TWO_SIDED|95.0|-8.39|16.81||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||4 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||16.81|-8.39|0.519
72423637|NCT01216163|144357931|SUPERIORITY_OR_OTHER||Difference in proportion|61.14|||<|0.001|TWO_SIDED|95.0|47.6|74.68||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||4 hours: Treatment difference (Acetaminophen - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||74.68|47.60|<0.001
72332921|NCT04283994|144190271|SUPERIORITY||Mean Difference (Final Values)|-0.33||||1.032|TWO_SIDED|95.0|-1.0|0.35||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.|Mean difference = clinician-facing intervention - usual care. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.|Complete case analysis.||0.35|-1.00|1.032
72332922|NCT04283994|144190271|SUPERIORITY||Mean Difference (Final Values)|0.04||||2.742|TWO_SIDED|95.0|-0.7|0.78||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.|Mean difference = bi-directional intervention - clinician-facing intervention. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.|Complete case analysis.||0.78|-0.70|2.742
72332923|NCT04283994|144190272|SUPERIORITY||Mean Difference (Final Values)|-0.02||||2.658|TWO_SIDED|95.0|-0.26|0.22||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.|Mean difference = bi-directional intervention - usual care. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.|Complete case analysis.||0.22|-0.26|2.658
72332924|NCT04283994|144190272|SUPERIORITY||Mean Difference (Final Values)|0.07||||1.523|TWO_SIDED|95.0|-0.14|0.29||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.|Mean difference = clinician-facing intervention - usual care. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.|Complete case analysis.||0.29|-0.14|1.523
72332925|NCT04283994|144190272|SUPERIORITY||Mean Difference (Final Values)|-0.09||||1.381|TWO_SIDED|95.0|-0.33|0.15||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.|Mean difference = bi-directional intervention - clinician-facing intervention. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.|||0.15|-0.33|1.381
72332926|NCT04283994|144190273|SUPERIORITY||Mean Difference (Final Values)|0.04||||2.191|TWO_SIDED|95.0|-0.18|0.25||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.|Mean difference = bi-directional intervention - usual care. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.|Complete case analysis.||0.25|-0.18|2.191
72332927|NCT04283994|144190273|SUPERIORITY||Mean Difference (Final Values)|0.04||||2.138|TWO_SIDED|95.0|-0.19|0.27||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.|Mean difference = clinician-facing intervention - usual care. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.|Complete case analysis.||0.27|-0.19|2.138
72332928|NCT04283994|144190273|SUPERIORITY||Mean Difference (Final Values)|-0.01||||2.879|TWO_SIDED|95.0|-0.23|22.0||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.|Mean difference = bi-directional intervention - clinician-facing intervention. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.|Complete case analysis.||022|-0.23|2.879
72332929|NCT00487942|144190306|SUPERIORITY_OR_OTHER||Effect size|-0.04|||||TWO_SIDED|95.0|-0.81|0.73||Inferential statistics were not performed.|ANCOVA|||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.73|-0.81|
72332930|NCT00487942|144190306|SUPERIORITY_OR_OTHER||Effect size|0.09|||||TWO_SIDED|95.0|-0.68|0.86||Inferential statistics were not performed|ANCOVA|||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.86|-0.68|
72332931|NCT00487942|144190306|SUPERIORITY_OR_OTHER||Effect size|0.15|||||TWO_SIDED|95.0|-0.66|0.95||Inferential statistics were not performed.|ANCOVA|||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.95|-0.66|
72423638|NCT01216163|144357931|SUPERIORITY_OR_OTHER||Difference in proportion|66.44|||<|0.001|TWO_SIDED|95.0|53.38|79.51||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||5 hours: Treatment difference (Ibuprofen sodium - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||79.51|53.38|<0.001
72423639|NCT01216163|144357931|SUPERIORITY_OR_OTHER||Difference in proportion|5.31||||0.412|TWO_SIDED|95.0|-7.22|17.83||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||5 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||17.83|-7.22|0.412
72423640|NCT01216163|144357931|SUPERIORITY_OR_OTHER||Difference in proportion|61.14|||<|0.001|TWO_SIDED|95.0|47.6|74.68||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||5 hours: Treatment difference (Acetaminophen - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||74.68|47.60|<0.001
72423641|NCT01216163|144357931|SUPERIORITY_OR_OTHER||Difference in proportion|66.44|||<|0.001|TWO_SIDED|95.0|53.38|79.51||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||6 hours: Treatment difference (Ibuprofen sodium - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||79.51|53.38|<0.001
72423642|NCT01216163|144357931|SUPERIORITY_OR_OTHER||Difference in proportion|5.31||||0.412|TWO_SIDED|95.0|-7.22|17.83||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||6 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||17.83|-7.22|0.412
72423643|NCT01216163|144357931|SUPERIORITY_OR_OTHER||Difference in proportion|61.14|||<|0.001|TWO_SIDED|95.0|47.6|74.68||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||6 hours: Treatment difference (Acetaminophen - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||74.68|47.60|<0.001
72423644|NCT01216163|144357932|SUPERIORITY_OR_OTHER||Difference in proportion|26.4|||<|0.001|TWO_SIDED|95.0|15.87|36.93||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||0.25 hours: Treatment difference (Ibuprofen sodium - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||36.93|15.87|<0.001
72423645|NCT01216163|144357932|SUPERIORITY_OR_OTHER||Difference in proportion|3.53||||0.602|TWO_SIDED|95.0|-9.85|16.91||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||0.25 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||16.91|-9.85|0.602
72423646|NCT01216163|144357932|SUPERIORITY_OR_OTHER||Difference in proportion|22.72||||0.001|TWO_SIDED|95.0|12.39|33.05||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||0.25 hours: Treatment difference (Acetaminophen - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||33.05|12.39|0.001
72423647|NCT01216163|144357932|SUPERIORITY_OR_OTHER||Difference in proportion|60.37|||<|0.001|TWO_SIDED|95.0|48.61|72.12||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||0.5 hours: Treatment difference (Ibuprofen sodium - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||72.12|48.61|<0.001
72423648|NCT01216163|144357932|SUPERIORITY_OR_OTHER||Difference in proportion|2.25||||0.761|TWO_SIDED|95.0|-12.1|16.59||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||0.5 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||16.59|-12.10|0.761
72423649|NCT01216163|144357932|SUPERIORITY_OR_OTHER||Difference in proportion|58.32|||<|0.001|TWO_SIDED|95.0|46.59|70.05||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||0.5 hours: Treatment difference (Acetaminophen - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||70.05|46.59|<0.001
72423650|NCT01216163|144357932|SUPERIORITY_OR_OTHER||Difference in proportion|67.52|||<|0.001|TWO_SIDED|95.0|54.91|80.12||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1 hour: Treatment difference (Ibuprofen sodium - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||80.12|54.91|<0.001
72332932|NCT00487942|144190307|SUPERIORITY_OR_OTHER||Effect size|0.02|||||TWO_SIDED|95.0|-0.8|0.83||Inferential statistics were not performed||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.83|-0.80|
72423651|NCT01216163|144357932|SUPERIORITY_OR_OTHER||Difference in proportion|5.42||||0.41|TWO_SIDED|95.0|-7.34|18.18||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1 hour: Treatment difference (Ibuprofen sodium - Acetaminophen) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||18.18|-7.34|0.410
72423652|NCT01216163|144357932|SUPERIORITY_OR_OTHER||Difference in proportion|62.13|||<|0.001|TWO_SIDED|95.0|48.96|75.29||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1 hour: Treatment difference (Acetaminophen - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||75.29|48.96|<0.001
72423653|NCT01216163|144357932|SUPERIORITY_OR_OTHER||Difference in proportion|68.64|||<|0.001|TWO_SIDED|95.0|56.11|81.16||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1.5 hours: Treatment difference (Ibuprofen sodium - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||81.16|56.11|<0.001
72423654|NCT01216163|144357932|SUPERIORITY_OR_OTHER||Difference in proportion|5.31||||0.412|TWO_SIDED|95.0|-7.22|17.83||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1.5 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||17.83|-7.22|0.412
72423655|NCT01216163|144357932|SUPERIORITY_OR_OTHER||Difference in proportion|63.34|||<|0.001|TWO_SIDED|95.0|50.32|76.35||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1.5 hours: Treatment difference (Acetaminophen - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||76.35|50.32|<0.001
72423656|NCT01216163|144357932|SUPERIORITY_OR_OTHER||Difference in proportion|66.44|||<|0.001|TWO_SIDED|95.0|53.38|79.51||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||2 hours: Treatment difference (Ibuprofen sodium - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||79.51|53.38|<0.001
72423657|NCT01216163|144357932|SUPERIORITY_OR_OTHER||Difference in proportion|5.31||||0.412|TWO_SIDED|95.0|-7.22|17.83||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||2 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||17.83|-7.22|0.412
72423658|NCT01216163|144357932|SUPERIORITY_OR_OTHER||Difference in proportion|61.14|||<|0.001|TWO_SIDED|95.0|47.6|74.68||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||2 hours: Treatment difference (Acetaminophen - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||74.68|47.60|<0.001
72423659|NCT01216163|144357932|SUPERIORITY_OR_OTHER||Difference in proportion|66.44|||<|0.001|TWO_SIDED|95.0|53.38|79.51||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||3 hours: Treatment difference (Ibuprofen sodium - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||79.51|53.38|<0.001
72423660|NCT01216163|144357932|SUPERIORITY_OR_OTHER||Difference in proportion|5.31||||0.412|TWO_SIDED|95.0|-7.22|17.83||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||3 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||17.83|-7.22|0.412
72423661|NCT01216163|144357932|SUPERIORITY_OR_OTHER||Difference in proportion|61.14|||<|0.001|TWO_SIDED|95.0|47.6|74.68||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||3 hours: Treatment difference (Acetaminophen - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||74.68|47.60|<0.001
72332933|NCT00487942|144190307|SUPERIORITY_OR_OTHER||Effect size|0.31|||||TWO_SIDED|95.0|-0.51|1.14||Inferential statistics were not performed||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||1.14|-0.51|
72332934|NCT00487942|144190307|SUPERIORITY_OR_OTHER||Effect size|0.16|||||TWO_SIDED|95.0|-0.66|0.98||Inferential statistics were not performed||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.98|-0.66|
72332935|NCT00487942|144190308|SUPERIORITY_OR_OTHER||Effect size|0.25|||||TWO_SIDED|95.0|-0.51|1.01||Inferential statistics were not performed||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||1.01|-0.51|
72332936|NCT00487942|144190308|SUPERIORITY_OR_OTHER||Effect size|-0.1|||||TWO_SIDED|95.0|-0.86|0.66||Inferential statistics were not performed||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.66|-0.86|
72332937|NCT00487942|144190308|SUPERIORITY_OR_OTHER||Effect size|0.49|||||TWO_SIDED|95.0|-0.31|1.28||Inferential statistics were not performed||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||1.28|-0.31|
72332938|NCT00487942|144190309|SUPERIORITY_OR_OTHER||Effect Size|-0.27|||||TWO_SIDED|95.0|-1.03|0.48||Inferential statistics were not performed||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.48|-1.03|
72332939|NCT00487942|144190309|SUPERIORITY_OR_OTHER||Effect Size|0.11|||||TWO_SIDED|95.0|-0.65|0.88||Inferential Statistics were not performed||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.88|-0.65|
72332940|NCT00487942|144190309|SUPERIORITY_OR_OTHER||Effect Size|-0.18|||||TWO_SIDED|95.0|-0.97|0.6||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.60|-0.97|
72332941|NCT00487942|144190310|SUPERIORITY_OR_OTHER||Effect Size|-0.32|||||TWO_SIDED|95.0|-1.08|0.44||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.44|-1.08|
72332942|NCT00487942|144190310|SUPERIORITY_OR_OTHER||Effect Size|-0.02|||||TWO_SIDED|95.0|-0.77|0.74||Inferential Statistics were not performed||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.74|-0.77|
72332943|NCT00487942|144190310|SUPERIORITY_OR_OTHER||Effect Size|-0.1|||||TWO_SIDED|95.0|-0.89|0.68||Inferential statistics were not performed||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.68|-0.89|
72332944|NCT00487942|144190311|SUPERIORITY_OR_OTHER||Effect Size|0.15|||||TWO_SIDED|95.0|-0.61|0.9||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.90|-0.61|
72332945|NCT00487942|144190311|SUPERIORITY_OR_OTHER||Effect Size|0.25|||||TWO_SIDED|95.0|-0.5|1.01||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||1.01|-0.50|
72423662|NCT01216163|144357932|SUPERIORITY_OR_OTHER||Difference in proportion|66.44|||<|0.001|TWO_SIDED|95.0|53.38|79.51||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||4 hours: Treatment difference (Ibuprofen sodium - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||79.51|53.38|<0.001
72423663|NCT01216163|144357932|SUPERIORITY_OR_OTHER||Difference in proportion|5.31||||0.412|TWO_SIDED|95.0|-7.22|17.83||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||4 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||17.83|-7.22|0.412
72423664|NCT01216163|144357932|SUPERIORITY_OR_OTHER||Difference in proportion|61.14|||<|0.001|TWO_SIDED|95.0|47.6|74.68||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||4 hours: Treatment difference (Acetaminophen - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||74.68|47.60|<0.001
72423665|NCT01216163|144357932|SUPERIORITY_OR_OTHER||Difference in proportion|66.44|||<|0.001|TWO_SIDED|95.0|53.38|79.51||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||5 hours: Treatment difference (Ibuprofen sodium - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||79.51|53.38|<0.001
72423666|NCT01216163|144357932|SUPERIORITY_OR_OTHER||Difference in proportion|5.31||||0.412|TWO_SIDED|95.0|-7.22|17.83||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||5 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||17.83|-7.22|0.412
72423667|NCT01216163|144357932|SUPERIORITY_OR_OTHER||Difference in proportion|61.14|||<|0.001|TWO_SIDED|95.0|47.6|74.68||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||5 hours: Treatment difference (Acetaminophen - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||74.68|47.60|<0.001
72423668|NCT01216163|144357932|SUPERIORITY_OR_OTHER||Difference in proportion|66.44|||<|0.001|TWO_SIDED|95.0|53.38|79.51||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||6 hours: Treatment difference (Ibuprofen sodium - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||79.51|53.38|<0.001
72423669|NCT01216163|144357932|SUPERIORITY_OR_OTHER||Difference in proportion|5.31||||0.412|TWO_SIDED|95.0|-7.22|17.83||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||6 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||17.83|-7.22|0.412
72423670|NCT01216163|144357932|SUPERIORITY_OR_OTHER||Difference in proportion|61.14|||<|0.001|TWO_SIDED|95.0|47.6|74.68||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||6 hours: Treatment difference (Acetaminophen - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||74.68|47.60|<0.001
72423671|NCT01216163|144357933|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.13|||<|0.001|TWO_SIDED|95.0|0.08|0.22||p-value was calculated using PH model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Proportional hazards model|||HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model.||0.22|0.08|<0.001
72332946|NCT00487942|144190311|SUPERIORITY_OR_OTHER||Effect Size|0.46|||||TWO_SIDED|95.0|-0.34|1.25||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||1.25|-0.34|
72423672|NCT01216163|144357933|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.76||||0.303|TWO_SIDED|95.0|0.45|1.28||p-value was calculated using PH model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Proportional hazards model|||HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model.||1.28|0.45|0.303
72423673|NCT01216163|144357933|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.17|||<|0.001|TWO_SIDED|95.0|0.1|0.28||p-value was calculated using PH model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Proportional hazards model|||HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model.||0.28|0.10|<0.001
72332947|NCT00487942|144190312|SUPERIORITY_OR_OTHER||Effect Size|0.45|||||TWO_SIDED|95.0|-0.33|1.23||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||1.23|-0.33|
72332948|NCT00487942|144190312|SUPERIORITY_OR_OTHER||Effect Size|0.34|||||TWO_SIDED|95.0|-0.42|1.1||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||1.10|-0.42|
72332949|NCT00487942|144190312|SUPERIORITY_OR_OTHER||Effect Size|0.13|||||TWO_SIDED|95.0|-0.68|0.93||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.93|-0.68|
72332950|NCT00487942|144190313|SUPERIORITY_OR_OTHER||Effect Size|0.39|||||TWO_SIDED|95.0|-0.37|1.15||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||1.15|-0.37|
72332951|NCT00487942|144190313|SUPERIORITY_OR_OTHER||Effect Size|-0.05|||||TWO_SIDED|95.0|-0.81|0.7||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.70|-0.81|
72332952|NCT00487942|144190313|SUPERIORITY_OR_OTHER||Effect Size|-0.01|||||TWO_SIDED|95.0|-0.8|0.77||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.77|-0.80|
72332953|NCT00487942|144190314|SUPERIORITY_OR_OTHER||Effect Size|-0.99|||||TWO_SIDED|95.0|-1.79|-0.19||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||-0.19|-1.79|
72332954|NCT00487942|144190314|SUPERIORITY_OR_OTHER||Effect Size|-0.66|||||TWO_SIDED|95.0|-1.44|0.11||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.11|-1.44|
72332955|NCT00487942|144190314|SUPERIORITY_OR_OTHER||Effect Size|-0.03|||||TWO_SIDED|95.0|-0.82|0.75||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.75|-0.82|
72332956|NCT00487942|144190315|SUPERIORITY_OR_OTHER||Effect Size|0.46|||||TWO_SIDED|95.0|-0.3|1.23||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||1.23|-0.30|
72332957|NCT00487942|144190315|SUPERIORITY_OR_OTHER||Effect Size|0.08|||||TWO_SIDED|95.0|-0.68|0.83||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.83|-0.68|
72332958|NCT00487942|144190315|SUPERIORITY_OR_OTHER||Effect Size|0.81|||||TWO_SIDED|95.0|0.0|1.63||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||1.63|-0.00|
72332959|NCT00487942|144190316|SUPERIORITY_OR_OTHER||Effect Size|-0.39|||||TWO_SIDED|95.0|-1.16|0.37||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.37|-1.16|
72332960|NCT00487942|144190316|SUPERIORITY_OR_OTHER||Effect Size|-0.45|||||TWO_SIDED|95.0|-1.21|0.31||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.31|-1.21|
72332961|NCT00487942|144190316|SUPERIORITY_OR_OTHER||Effect Size|-0.2|||||TWO_SIDED|95.0|-0.99|0.58||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.58|-0.99|
72423674|NCT01216163|144357934|SUPERIORITY_OR_OTHER||Difference in proportion|-40.1|||<|0.001|TWO_SIDED|95.0|-55.39|-24.8||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1.5 hours: Treatment difference (Ibuprofen sodium - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-24.80|-55.39|<0.001
72423675|NCT01216163|144357934|SUPERIORITY_OR_OTHER||Difference in proportion|-0.12||||0.958|TWO_SIDED|95.0|-4.52|4.28||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1.5 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||4.28|-4.52|0.958
72332962|NCT00487942|144190317|SUPERIORITY_OR_OTHER||Effect Size|0.47|||||TWO_SIDED|95.0|-0.3|1.23||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||1.23|-0.30|
72332963|NCT00487942|144190317|SUPERIORITY_OR_OTHER||Effect Size|0.28|||||TWO_SIDED|95.0|-0.48|1.04||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||1.04|-0.48|
72332964|NCT00487942|144190317|SUPERIORITY_OR_OTHER||Effect size|0.14|||||TWO_SIDED|95.0|-0.64|0.93||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.93|-0.64|
72332965|NCT00487942|144190318|SUPERIORITY_OR_OTHER||Effect size|-0.23|||||TWO_SIDED|95.0|-0.99|0.52||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.52|-0.99|
72332966|NCT00487942|144190318|SUPERIORITY_OR_OTHER||Effect size|0.34|||||TWO_SIDED|95.0|-0.42|1.1||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||1.10|-0.42|
72423676|NCT01216163|144357934|SUPERIORITY_OR_OTHER||Difference in proportion|-40.19|||<|0.001|TWO_SIDED|95.0|-55.51|-24.87||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1.5 hours: Treatment difference (Acetaminophen - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-24.87|-55.51|<0.001
72423677|NCT01216163|144357934|SUPERIORITY_OR_OTHER||Difference in proportion|-63.4|||<|0.001|TWO_SIDED|95.0|-77.81|-48.99||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||2 hours: Treatment difference (Ibuprofen sodium - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-48.99|-77.81|<0.001
72423678|NCT01216163|144357934|SUPERIORITY_OR_OTHER||Difference in proportion|-7.17||||0.108|TWO_SIDED|95.0|-15.91|1.57||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||2 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||1.57|-15.91|0.108
72423679|NCT01216163|144357934|SUPERIORITY_OR_OTHER||Difference in proportion|-56.39|||<|0.001|TWO_SIDED|95.0|-71.68|-41.09||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||2 hours: Treatment difference (Acetaminophen - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-41.09|-71.68|<0.001
72423680|NCT01216163|144357934|SUPERIORITY_OR_OTHER||Difference in proportion|-71.01|||<|0.001|TWO_SIDED|95.0|-84.09|-57.93||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||3 hours: Treatment difference (Ibuprofen sodium - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-57.93|-84.09|<0.001
72423681|NCT01216163|144357934|SUPERIORITY_OR_OTHER||Difference in proportion|-9.82||||0.083|TWO_SIDED|95.0|-20.18|1.16||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||3 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||1.16|-20.18|0.083
72423682|NCT01216163|144357934|SUPERIORITY_OR_OTHER||Difference in proportion|-61.14|||<|0.001|TWO_SIDED|95.0|-75.4|-46.87||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||3 hours: Treatment difference (Acetaminophen - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-46.87|-75.40|<0.001
72423683|NCT01216163|144357934|SUPERIORITY_OR_OTHER||Difference in proportion|-66.37|||<|0.001|TWO_SIDED|95.0|-80.08|-52.66||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||4 hours: Treatment difference (Ibuprofen sodium - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-52.66|-80.08|<0.001
72423684|NCT01216163|144357934|SUPERIORITY_OR_OTHER||Difference in proportion|-11.03||||0.079|TWO_SIDED|95.0|-23.37|1.21||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||4 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||1.21|-23.37|0.079
72423685|NCT01216163|144357934|SUPERIORITY_OR_OTHER||Difference in proportion|-55.53|||<|0.001|TWO_SIDED|95.0|-70.12|-40.85||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||4 hours: Treatment difference (Acetaminophen - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-40.85|-70.12|<0.001
72423686|NCT01216163|144357934|SUPERIORITY_OR_OTHER||Difference in proportion|-57.33|||<|0.001|TWO_SIDED|95.0|-71.9|-42.77||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||5 hours: Treatment difference (Ibuprofen sodium - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-42.77|-71.90|<0.001
72423687|NCT01216163|144357934|SUPERIORITY_OR_OTHER||Difference in proportion|-7.73||||0.263|TWO_SIDED|95.0|-21.08|5.63||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||5 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||5.63|-21.08|0.263
72423688|NCT01216163|144357934|SUPERIORITY_OR_OTHER||Difference in proportion|-49.93|||<|0.001|TWO_SIDED|95.0|-64.74|-35.12||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||5 hours: Treatment difference (Acetaminophen - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-35.12|-64.74|<0.001
72423689|NCT01216163|144357934|SUPERIORITY_OR_OTHER||Difference in proportion|-52.75|||<|0.001|TWO_SIDED|95.0|-67.62|-37.88||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||6 hours: Treatment difference (Ibuprofen sodium - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-37.88|-67.62|<0.001
72423690|NCT01216163|144357934|SUPERIORITY_OR_OTHER||Difference in proportion|-5.51||||0.439|TWO_SIDED|95.0|-19.27|8.25||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||6 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||8.25|-19.27|0.439
72423691|NCT01216163|144357934|SUPERIORITY_OR_OTHER||Difference in proportion|-47.72|||<|0.001|TWO_SIDED|95.0|-62.62|-32.83||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||6 hours: Treatment difference (Acetaminophen - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-32.83|-62.62|<0.001
72423692|NCT01216163|144357935|SUPERIORITY_OR_OTHER||Difference in proportion|-1.21||||0.294|TWO_SIDED|95.0|-3.59|1.17||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||0.25 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||1.17|-3.59|0.294
72423693|NCT01216163|144357935|SUPERIORITY_OR_OTHER||Difference in proportion|1.21||||0.458|TWO_SIDED|95.0|-1.16|3.58||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||0.25 hours: Treatment difference (Acetaminophen - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||3.58|-1.16|0.458
72423694|NCT01216163|144357935|SUPERIORITY_OR_OTHER||Difference in proportion|6.81||||0.073|TWO_SIDED|95.0|1.57|12.06||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||0.5 hours: Treatment difference (Ibuprofen sodium - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||12.06|1.57|0.073
72423695|NCT01216163|144357935|SUPERIORITY_OR_OTHER||Difference in proportion|1.96||||0.583|TWO_SIDED|95.0|-4.94|8.85||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||0.5 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||8.85|-4.94|0.583
72423696|NCT01216163|144357935|SUPERIORITY_OR_OTHER||Difference in proportion|4.81||||0.137|TWO_SIDED|95.0|0.14|9.49||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||0.5 hours: Treatment difference (Acetaminophen - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||9.49|0.14|0.137
72423697|NCT01216163|144357935|SUPERIORITY_OR_OTHER||Difference in proportion|23.86|||<|0.001|TWO_SIDED|95.0|14.81|32.91||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1 hour: Treatment difference (Ibuprofen sodium - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||32.91|14.81|<0.001
72423698|NCT01216163|144357935|SUPERIORITY_OR_OTHER||Difference in proportion|8.45||||0.165|TWO_SIDED|95.0|-3.43|20.33||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1 hour: Treatment difference (Ibuprofen sodium - Acetaminophen) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||20.33|-3.43|0.165
72423699|NCT01216163|144357935|SUPERIORITY_OR_OTHER||Difference in proportion|15.46||||0.006|TWO_SIDED|95.0|7.66|23.26||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1 hour: Treatment difference (Acetaminophen - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||23.26|7.66|0.006
72423700|NCT01216163|144357935|SUPERIORITY_OR_OTHER||Difference in proportion|29.41|||<|0.001|TWO_SIDED|95.0|19.78|39.05||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1.5 hours: Treatment difference (Ibuprofen sodium - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||39.05|19.78|<0.001
72423701|NCT01216163|144357935|SUPERIORITY_OR_OTHER||Difference in proportion|4.61||||0.497|TWO_SIDED|95.0|-8.78|17.99||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1.5 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||17.99|-8.78|0.497
72332967|NCT00487942|144190318|SUPERIORITY_OR_OTHER||Effect size|0.06|||||TWO_SIDED|95.0|-0.72|0.85||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.85|-0.72|
72332968|NCT00487942|144190319|SUPERIORITY_OR_OTHER||Effect size|-0.2|||||TWO_SIDED|95.0|-0.95|0.56||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.56|-0.95|
72332969|NCT00487942|144190319|SUPERIORITY_OR_OTHER||Effect size|-0.35|||||TWO_SIDED|95.0|-1.11|0.41||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.41|-1.11|
72332970|NCT00487942|144190319|SUPERIORITY_OR_OTHER||Effect size|-0.16|||||TWO_SIDED|95.0|-0.95|0.62||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.62|-0.95|
72332971|NCT00487942|144190320|SUPERIORITY_OR_OTHER||Effect size|-0.51|||||TWO_SIDED|95.0|-1.3|0.27||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.27|-1.30|
72332972|NCT00487942|144190320|SUPERIORITY_OR_OTHER||Effect size|0.55|||||TWO_SIDED|95.0|-0.25|1.35||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||1.35|-0.25|
72332973|NCT00487942|144190320|SUPERIORITY_OR_OTHER||Effect size|0.02|||||TWO_SIDED|95.0|-0.78|0.82||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.82|-0.78|
72332974|NCT00487942|144190321|SUPERIORITY_OR_OTHER||Effect size|-0.64|||||TWO_SIDED|95.0|-1.43|0.15||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.15|-1.43|
72332975|NCT00487942|144190321|SUPERIORITY_OR_OTHER||Effect Size|-0.26|||||TWO_SIDED|95.0|-1.05|0.53||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.53|-1.05|
72332976|NCT00487942|144190321|SUPERIORITY_OR_OTHER||Effect size|-0.1|||||TWO_SIDED|95.0|-0.9|0.7||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.70|-0.90|
72332977|NCT00487942|144190322|SUPERIORITY_OR_OTHER||Effect size|-0.15|||||TWO_SIDED|95.0|-0.92|0.63||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.63|-0.92|
72332978|NCT00487942|144190322|SUPERIORITY_OR_OTHER||Effect size|0.25|||||TWO_SIDED|95.0|-0.54|1.04||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||1.04|-0.54|
72332979|NCT00487942|144190322|SUPERIORITY_OR_OTHER||Effect size|-0.31|||||TWO_SIDED|95.0|-1.12|0.49||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.49|-1.12|
72332980|NCT00487942|144190323|SUPERIORITY_OR_OTHER||Effect size|-0.44|||||TWO_SIDED|95.0|-1.22|0.33||Inferential statistics not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the Trails B Test score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.33|-1.22|
72332981|NCT00487942|144190323|SUPERIORITY_OR_OTHER||Effect size|-0.89|||||TWO_SIDED|95.0|-1.69|-0.08||Inferential statistics not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the Trails B Test score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||-0.08|-1.69|
72332982|NCT00487942|144190323|SUPERIORITY_OR_OTHER||Effect size|-0.13|||||TWO_SIDED|95.0|-0.95|0.7||Inferential statistics not performed||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the Trails B Test score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.70|-0.95|
72332983|NCT00487942|144190369|SUPERIORITY_OR_OTHER||Effect size|0.12|||||TWO_SIDED|95.0|-0.76|1.0||Inferential statistics were not performed||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the SCoRS Total score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||1.0|-0.76|
72332984|NCT00487942|144190369|SUPERIORITY_OR_OTHER||Effect size|-0.33|||||TWO_SIDED|95.0|-1.15|0.48||Inferential statistics were not performed||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the SCoRS Total score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.48|-1.15|
72332985|NCT00487942|144190369|SUPERIORITY_OR_OTHER||Effect size|0.27|||||TWO_SIDED|95.0|-0.61|1.15||Inferential statistics were not performed||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the SCoRS Total score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||1.15|-0.61|
72423702|NCT01216163|144357935|SUPERIORITY_OR_OTHER||Difference in proportion|25.13|||<|0.001|TWO_SIDED|95.0|15.81|34.46||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1.5 hours: Treatment difference (Acetaminophen - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||34.46|15.81|<0.001
72332986|NCT00487942|144190370|SUPERIORITY_OR_OTHER||Effect size|0.33|||||TWO_SIDED|95.0|-0.58|1.24||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||1.24|-0.58|
72332987|NCT00487942|144190370|SUPERIORITY_OR_OTHER||Effect size|-0.05|||||TWO_SIDED|95.0|-0.91|0.81||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.81|-0.91|
72423703|NCT01216163|144357935|SUPERIORITY_OR_OTHER||Difference in proportion|31.78|||<|0.001|TWO_SIDED|95.0|20.03|43.53||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||2 hours: Treatment difference (Ibuprofen sodium - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||43.53|20.03|<0.001
72423704|NCT01216163|144357935|SUPERIORITY_OR_OTHER||Difference in proportion|6.7||||0.349|TWO_SIDED|95.0|-7.38|20.79||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||2 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||20.79|-7.38|0.349
72423705|NCT01216163|144357935|SUPERIORITY_OR_OTHER||Difference in proportion|25.34|||<|0.001|TWO_SIDED|95.0|13.73|36.94||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||2 hours: Treatment difference (Acetaminophen - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||36.94|13.73|<0.001
72423706|NCT01216163|144357935|SUPERIORITY_OR_OTHER||Difference in proportion|37.64|||<|0.001|TWO_SIDED|95.0|25.47|49.81||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||3 hours: Treatment difference (Ibuprofen sodium - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||49.81|25.47|<0.001
72332988|NCT00487942|144190370|SUPERIORITY_OR_OTHER||Effect size|-0.44|||||TWO_SIDED|95.0|-1.33|0.45||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.45|-1.33|
72423707|NCT01216163|144357935|SUPERIORITY_OR_OTHER||Difference in proportion|8.85||||0.233|TWO_SIDED|95.0|-5.72|23.42||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||3 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||23.42|-5.72|0.233
72423708|NCT01216163|144357935|SUPERIORITY_OR_OTHER||Difference in proportion|28.96|||<|0.001|TWO_SIDED|95.0|17.17|40.75||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||3 hours: Treatment difference (Acetaminophen - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||40.75|17.17|<0.001
72423709|NCT01216163|144357935|SUPERIORITY_OR_OTHER||Difference in proportion|38.73|||<|0.001|TWO_SIDED|95.0|25.87|51.6||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||4 hours: Treatment difference (Ibuprofen sodium - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||51.60|25.87|<0.001
72423710|NCT01216163|144357935|SUPERIORITY_OR_OTHER||Difference in proportion|9.83||||0.189|TWO_SIDED|95.0|-4.8|24.45||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||4 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||24.45|-4.80|0.189
72423711|NCT01216163|144357935|SUPERIORITY_OR_OTHER||Difference in proportion|29.19|||<|0.001|TWO_SIDED|95.0|16.71|41.66||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||4 hours: Treatment difference (Acetaminophen - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||41.66|16.71|<0.001
72423712|NCT01216163|144357935|SUPERIORITY_OR_OTHER||Difference in proportion|36.55|||<|0.001|TWO_SIDED|95.0|23.22|49.88||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||5 hours: Treatment difference (Ibuprofen sodium - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||49.88|23.22|<0.001
72423713|NCT01216163|144357935|SUPERIORITY_OR_OTHER||Difference in proportion|9.83||||0.189|TWO_SIDED|95.0|-4.8|24.45||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||5 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||24.45|-4.80|0.189
72423714|NCT01216163|144357935|SUPERIORITY_OR_OTHER||Difference in proportion|26.97|||<|0.001|TWO_SIDED|95.0|14.0|39.94||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||5 hours: Treatment difference (Acetaminophen - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||39.94|14.00|<0.001
72423715|NCT01216163|144357935|SUPERIORITY_OR_OTHER||Difference in proportion|37.72|||<|0.001|TWO_SIDED|95.0|24.36|51.07||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||6 hours: Treatment difference (Ibuprofen sodium - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||51.07|24.36|<0.001
72423716|NCT01216163|144357935|SUPERIORITY_OR_OTHER||Difference in proportion|10.97||||0.144|TWO_SIDED|95.0|-3.67|25.61||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||6 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||25.61|-3.67|0.144
72423717|NCT01216163|144357935|SUPERIORITY_OR_OTHER||Difference in proportion|26.97|||<|0.001|TWO_SIDED|95.0|14.0|39.94||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||6 hours: Treatment difference (Acetaminophen - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||39.94|14.00|<0.001
72423718|NCT01216163|144357936|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.87|||<|0.001|TWO_SIDED|95.0|0.78|0.96||P-value was calculated using CMH test with modified ridit scores, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||Treatment difference (Ibuprofen sodium - Placebo) and the associated CI were calculated based on the weighted Gamma statistic.||0.96|0.78|<0.001
72423719|NCT01216163|144357936|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.25||||0.02|TWO_SIDED|95.0|0.05|0.45||P-value was calculated using CMH test with modified ridit scores, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||Treatment difference (Ibuprofen sodium - Acetaminophen) and the associated CI were calculated based on the weighted Gamma statistic.||0.45|0.05|0.020
72423720|NCT01216163|144357936|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.77|||<|0.001|TWO_SIDED|95.0|0.63|0.91||P-value was calculated using CMH test with modified ridit scores, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||Treatment difference (Acetaminophen - Placebo) and the associated CI were calculated based on the weighted Gamma statistic.||0.91|0.63|<0.001
72423721|NCT02413463|144358004|SUPERIORITY|Chi-square test||||||0.18||||||This is the calculated p-value for the success rate in the Augmented Group Vs. Faden Group|Chi-squared|||An estimation of sample size was performed considering a study power of 0.8 with an alpha error of 0.05 aiming to detect a difference of 5 Δ in the postoperative angle disparity between the 2 groups, assuming a postoperative standard deviation of 6 Δ. Based on this estimation, a total of 24 eyes were found to be adequate in each group, and considering a 25% dropout during the follow-up, recruitment of 30 study subjects in each group was targeted||||0.18
72423722|NCT02413463|144358005|SUPERIORITY|||||||0.22||||||This is the calculated p-value for the postoperative angle of deviation with spectacles for distance in Augmented recession vs. Faden group (First row)|t-test, 2 sided|||||||0.22
72423723|NCT02413463|144358006|SUPERIORITY|||||||0.02||||||This is the calculated p-value for the postoperative angle of deviation without spectacles for near in Augmented recession vs. Faden group (Second row)|t-test, 2 sided|||||||0.02
72332989|NCT00487942|144190371|SUPERIORITY_OR_OTHER||Effect size|0.18|||||TWO_SIDED|95.0|-0.75|1.1||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||1.10|-0.75|
72423724|NCT02413463|144358007|SUPERIORITY|||||||0.03||||||This is the calculated p-value for the postoperative angle disparity in the Augmented Group Vs. Faden Group|t-test, 2 sided|||||||0.03
72423725|NCT02413463|144358008|SUPERIORITY||||||<|0.01||||||This is the calculated p-value for the intraoperative time in the Augmented Group Vs. Faden Group|t-test, 2 sided|||||||<0.01
72423726|NCT04146896|144358015|SUPERIORITY|||||||0.704|||||||t-test, 2 sided|||||||0.704
72423727|NCT04146896|144358016|SUPERIORITY|||||||0.684|||||||t-test, 2 sided|||||||.684
72332990|NCT00487942|144190371|SUPERIORITY_OR_OTHER||Effect size|-0.1|||||TWO_SIDED|95.0|-0.98|0.78||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.78|-0.98|
72332991|NCT00487942|144190371|SUPERIORITY_OR_OTHER||Effect size|0.37|||||TWO_SIDED|95.0|-0.54|1.27||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||1.27|-0.54|
72332992|NCT00487942|144190372|SUPERIORITY_OR_OTHER||Effect size|-0.38|||||TWO_SIDED|95.0|-1.14|0.38||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.38|-1.14|
72332993|NCT00487942|144190372|SUPERIORITY_OR_OTHER||Effect size|-0.13|||||TWO_SIDED|95.0|-0.89|0.63||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.63|-0.89|
72332994|NCT00487942|144190372|SUPERIORITY_OR_OTHER||Effect size|-0.05|||||TWO_SIDED|95.0|-0.84|0.73||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.73|-0.84|
72332995|NCT00487942|144190373|SUPERIORITY_OR_OTHER||Effect size|-0.41|||||TWO_SIDED|95.0|-1.21|0.4||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.40|-1.21|
72332996|NCT00487942|144190373|SUPERIORITY_OR_OTHER||Effect size|-0.29|||||TWO_SIDED|95.0|-1.09|0.52||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.52|-1.09|
72332997|NCT00487942|144190373|SUPERIORITY_OR_OTHER||Effect size|-0.69|||||TWO_SIDED|95.0|-1.51|0.14||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.14|-1.51|
72332998|NCT00487942|144190374|SUPERIORITY_OR_OTHER||Effect size|-0.24|||||TWO_SIDED|95.0|-1.06|0.58||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.58|-1.06|
72332999|NCT00487942|144190374|SUPERIORITY_OR_OTHER||Effect size|-0.05|||||TWO_SIDED|95.0|-0.85|0.75||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.75|-0.85|
72423728|NCT04146896|144358017|SUPERIORITY|||||||0.743|||||||t-test, 2 sided|||||||0.743
72423729|NCT04146896|144358018|SUPERIORITY|||||||0.483|||||||t-test, 2 sided|||||||.483
72423730|NCT04146896|144358019|SUPERIORITY|||||||0.199|||||||t-test, 2 sided|||||||.199
72423731|NCT04146896|144358020|SUPERIORITY|||||||0.273|||||||t-test, 2 sided|||||||.273
72423732|NCT04146896|144358021|SUPERIORITY|||||||0.668|||||||t-test, 2 sided|||||||.668
72423733|NCT02118337|144358026|SUPERIORITY||Rate difference|-23.8||||0.5494|TWO_SIDED|95.0|-72.8|31.1|||Fisher Exact|||||31.1|-72.8|0.5494
72333000|NCT00487942|144190374|SUPERIORITY_OR_OTHER||Effect size|-0.1|||||TWO_SIDED|95.0|-0.9|0.7||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.70|-0.90|
72333001|NCT00487942|144190377|SUPERIORITY_OR_OTHER||Effect size|-0.05|||||TWO_SIDED|95.0|-0.8|0.71||Inferential statistics were not performed||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the SANS Total score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.71|-0.80|
72333002|NCT00487942|144190377|SUPERIORITY_OR_OTHER||Effect size|-0.31|||||TWO_SIDED|95.0|-1.06|0.45||Inferential statistics were not performed||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the SANS Total score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.45|-1.06|
72333003|NCT00487942|144190377|SUPERIORITY_OR_OTHER||Effect size|0.11|||||TWO_SIDED|95.0|-0.68|0.89||Inferential statistics were not performed||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the SANS Total score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.89|-0.68|
72333004|NCT00487942|144190378|SUPERIORITY_OR_OTHER||Effect size|-0.13|||||TWO_SIDED|95.0|-0.88|0.63||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.63|-0.88|
72423734|NCT02118337|144358026|SUPERIORITY||Rate difference|-7.1||||0.513|TWO_SIDED|95.0|-33.6|20.0|||Fisher Exact|||||20.0|-33.6|0.5130
72423735|NCT03300570|144358078|SUPERIORITY|||||||0.15|||||||Wilcoxon (Mann-Whitney)|||||||0.15
72423736|NCT02296190|144358088|SUPERIORITY||||||<|0.05|||||||Fisher Exact|||Statistical analysis was performed with the Fisher's exact test to compare the conversion rate between the MSP-2017 groups and the placebo group.||||<0.05
72423737|NCT00717314|144358093|SUPERIORITY_OR_OTHER|||||||0.494|||||||ANOVA|||||||0.494
72423738|NCT00717314|144358096|SUPERIORITY_OR_OTHER|||||||0.374|||||||ANOVA|||Between group comparison at Baseline||||0.374
72423739|NCT00717314|144358096|SUPERIORITY_OR_OTHER|||||||0.685||||||Analysis of covariance (ANCOVA) model with calculated creatinine clearance at baseline as covariate, and study center and treatment\*study center as factors.|ANCOVA|||Change from Baseline at Week 16||||0.685
72423740|NCT00717314|144358096|SUPERIORITY_OR_OTHER|||||||0.722||||||ANCOVA model with calculated creatinine clearance at baseline as covariate, and study center and treatment\*study center as factors.|ANCOVA|||Change from Baseline at Week 28||||0.722
72423741|NCT00717314|144358096|SUPERIORITY_OR_OTHER|||||||0.432||||||ANCOVA model with calculated creatinine clearance at baseline as covariate, and study center and treatment\*study center as factors.|ANCOVA|||Change from Baseline at Week 40||||0.432
72423742|NCT00717314|144358097|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.11|||||TWO_SIDED|95.0|-5.342|5.561||||||||5.561|-5.342|
72423743|NCT00717314|144358098|SUPERIORITY_OR_OTHER|||||||0.616||||||ANCOVA model with calculated creatinine clearance at baseline as covariate, and study center and treatment\*study center as factors.|ANCOVA|||Change from Baseline at Week 16||||0.616
72333005|NCT00487942|144190378|SUPERIORITY_OR_OTHER||Effect size|0.05|||||TWO_SIDED|95.0|-0.72|0.82||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.82|-0.72|
72333006|NCT00487942|144190378|SUPERIORITY_OR_OTHER||Effect size|0.0|||||TWO_SIDED|95.0|-0.8|0.81||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.81|-0.80|
72333007|NCT00487942|144190379|SUPERIORITY_OR_OTHER||Effect size|-0.62|||||TWO_SIDED|95.0|-1.44|0.2||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.20|-1.44|
72333008|NCT00487942|144190379|SUPERIORITY_OR_OTHER||Effect size|-0.18|||||TWO_SIDED|95.0|-0.98|0.62||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.62|-0.98|
72333009|NCT00487942|144190379|SUPERIORITY_OR_OTHER||Effect size|-0.17|||||TWO_SIDED|95.0|-0.97|0.63||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.63|-0.97|
72333010|NCT00487942|144190380|SUPERIORITY_OR_OTHER||Effect size|-0.08|||||TWO_SIDED|95.0|-0.88|0.72||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.72|-0.88|
72333011|NCT00487942|144190380|SUPERIORITY_OR_OTHER||Effect size|-0.08|||||TWO_SIDED|95.0|-0.88|0.72||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.72|-0.88|
72333012|NCT00487942|144190380|SUPERIORITY_OR_OTHER||Effect size|0.08|||||TWO_SIDED|95.0|-0.72|0.89||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.89|-0.72|
72333013|NCT00487942|144190381|SUPERIORITY_OR_OTHER||Effect size|0.11|||||TWO_SIDED|95.0|-0.65|0.87||Inferential statistics were not performed||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the PANSS Negative Scale score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.87|-0.65|
72333014|NCT00487942|144190381|SUPERIORITY_OR_OTHER||Effect size|0.13|||||TWO_SIDED|95.0|-0.63|0.88||Inferential statistics were not performed||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the PANSS Negative Scale score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.88|-0.63|
72333015|NCT00487942|144190381|SUPERIORITY_OR_OTHER||Effect size|1.69|||||TWO_SIDED|95.0|0.78|2.6||Inferential statistics were not performed||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the PANSS Negative Scale score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||2.60|0.78|
72333016|NCT00487942|144190382|SUPERIORITY_OR_OTHER||Effect size|-0.3|||||TWO_SIDED|95.0|-1.06|0.46||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.46|-1.06|
72333017|NCT00487942|144190382|SUPERIORITY_OR_OTHER||Effect size|-0.1|||||TWO_SIDED|95.0|-0.87|0.67||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.67|-0.87|
72423744|NCT00717314|144358098|SUPERIORITY_OR_OTHER|||||||0.334||||||ANCOVA model with calculated creatinine clearance at baseline as covariate, and study center and treatment\*study center as factors.|ANCOVA|||Change from Baseline at Week 28||||0.334
72423745|NCT00717314|144358098|SUPERIORITY_OR_OTHER|||||||0.267||||||ANCOVA model with calculated creatinine clearance at baseline as covariate, and study center and treatment\*study center as factors.|ANCOVA|||Change from Baseline at Week 40||||0.267
72333018|NCT00487942|144190382|SUPERIORITY_OR_OTHER||Effect size|0.89|||||TWO_SIDED|95.0|0.05|1.74||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||1.74|0.05|
72423746|NCT00717314|144358098|SUPERIORITY_OR_OTHER|||||||0.764|||||||ANCOVA|ANCOVA model with calculated creatinine clearance at baseline as covariate, and study center and treatment\*study center as factors.||Change from Baseline at Week 52||||0.764
72423747|NCT00717314|144358099|SUPERIORITY_OR_OTHER|||||||1|||||||ANCOVA|||||||1.000
72423748|NCT03238300|144358128|SUPERIORITY||partial eta squared|0.02|||>|0.05|TWO_SIDED|95.0|0.0|0.22||P-value \>0.05 for main effect of medication (N-acetylcysteine vs. placebo)|Mixed Models Analysis|Random intercepts were used||"With 31 participants, the study has 99% power to detect such effects on glutamate levels (calculated based on d =1.13 \[reported in Schmaal et al., 2012\], α = 0.05, two-tailed).~We used linear mixed effects models with random intercepts with medication, visit, and sequence. Baseline metabolite levels and brain tissue composition \[GM:BM = GM/(GM+WM)\], cannabis use (days), and alcohol use disorder status (Yes/No) were included as covariates."||0.22|0.00|>0.05
72423749|NCT03238300|144358129|SUPERIORITY||||||>|0.05||||||P-value \>0.05 for main effect of medication (N-acetylcysteine vs. placebo) for all ROIs.|Mixed Models Analysis|Random intercepts were used for all models.||Contrast of interest was alcohol beverages vs. non-alcohol beverages. We used linear mixed effects models with random intercepts with medication, visit, and sequence. Baseline reactivity levels for each ROI, cannabis use (days), and an alcohol use covariate (quantity, frequency, AUD status, or AUD severity - depending on which best fit the model) were included as covariates. ROIs included were (left and right hemisphere): amygdala, caudate, insula, putamen, and nucleus accumbens.||||>0.05
72423750|NCT01975220|144358141|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing|Adjusted geometric mean ratio (%)|99.98|STANDARD_DEVIATION|5.4|<|0.0001|TWO_SIDED|90.0|97.275|102.751|||ANOVA||Adjusted geometric mean (GM) ratio(%) was calculated as GM of 'High dose, fasted:1 FDC tablet' divided by GM of 'High dose, fasted:3 single tablets'.The 'standard deviation' is actually intra-individual geometric coefficient of variation (gCV (%)).|||102.751|97.275|<0.0001
72423751|NCT01975220|144358141|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing|Adjusted geometric mean ratio (%)|97.09|STANDARD_DEVIATION|6.7|<|0.0001|TWO_SIDED|90.0|93.857|100.436|||ANOVA||"The adjusted geometric mean ratio (%) was calculated as the geometric mean of 'High dose, fed: 1 FDC tablet' divided by the geometric mean of 'High dose, fed: 3 single tablets'.~The 'standard deviation' is actually the intra-individual gCV (%)."|||100.436|93.857|<0.0001
72423752|NCT01975220|144358141|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing|Adjusted geometric mean ratio (%)|100.7|STANDARD_DEVIATION|4.9|<|0.0001|TWO_SIDED|90.0|98.28|103.18|||ANOVA||"The adjusted geometric mean ratio (%) was calculated as the geometric mean of 'Low dose, fasted: 2 FDC tablets' divided by the geometric mean of 'Low dose, fasted: 4 single tablets'.~The 'standard deviation' is actually the intra-individual gCV (%)."|||103.18|98.28|<0.0001
72333019|NCT00487942|144190383|SUPERIORITY_OR_OTHER||Effect size|-0.25|||||TWO_SIDED|95.0|-1.05|0.55||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.55|-1.05|
72333020|NCT00487942|144190383|SUPERIORITY_OR_OTHER||Effect size|0.29|||||TWO_SIDED|95.0|-0.52|1.09||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||1.09|-0.52|
72333021|NCT00487942|144190383|SUPERIORITY_OR_OTHER||Effect size|0.75|||||TWO_SIDED|95.0|-0.08|1.58||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||1.58|-0.08|
72423753|NCT01975220|144358142|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing|Adjusted geometric mean ratio (%)|94.65|STANDARD_DEVIATION|28.1||0.0256|TWO_SIDED|90.0|82.29|108.88|||ANOVA||The adjusted geometric mean ratio (%) was calculated as the geometric mean of 'High dose, fasted: 1 FDC tablet' divided by the geometric mean of 'High dose, fasted: 3 single tablets'. The 'standard deviation' is actually the intra-individual gCV (%).|||108.88|82.29|0.0256
72423754|NCT01975220|144358142|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing|Adjusted geometric mean ratio (%)|99.69|STANDARD_DEVIATION|7.1|<|0.0001|TWO_SIDED|90.0|96.25|103.26|||ANOVA||"The adjusted geometric mean ratio (%) was calculated as the geometric mean of 'High dose, fed: 1 FDC tablet' divided by the geometric mean of 'High dose, fed: 3 single tablets'.~The 'standard deviation' is actually the intra-individual gCV (%)."|||103.26|96.25|<0.0001
72423755|NCT01975220|144358142|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing|Adjusted geometric mean ratio (%)|99.76|STANDARD_DEVIATION|24.2||0.002|TWO_SIDED|90.0|88.65|112.27|||ANOVA||"The adjusted geometric mean ratio (%) was calculated as the geometric mean of 'Low dose, fasted: 2 FDC tablets' divided by the geometric mean of 'Low dose, fasted: 4 single tablets'.~The 'standard deviation' is actually the intra-individual gCV (%)."|||112.27|88.65|0.0020
72423756|NCT01975220|144358143|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing.|Adjusted geometric mean ratio (%)|100.1|STANDARD_DEVIATION|5.1|<|0.0001|TWO_SIDED|90.0|97.555|102.719|||ANOVA||The adjusted geometric mean ratio (%) was calculated as the geometric mean of 'High dose, fasted: 1 FDC tablet' divided by the geometric mean of 'High dose, fasted: 3 single tablets'. The 'standard deviation' is actually the intra-individual gCV (%).|||102.719|97.555|<0.0001
72333022|NCT00487942|144190384|SUPERIORITY_OR_OTHER||Effect size|0.02|||||TWO_SIDED|95.0|-0.78|0.82||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.82|-0.78|
72333023|NCT00487942|144190384|SUPERIORITY_OR_OTHER||Effect size|0.55|||||TWO_SIDED|95.0|-0.27|1.36||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||1.36|-0.27|
72423757|NCT01975220|144358143|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing.|Adjusted geometric mean ratio (%)|97.01|STANDARD_DEVIATION|7.0|<|0.0001|TWO_SIDED|90.0|93.622|100.531|||ANOVA||"The adjusted geometric mean ratio (%) was calculated as the geometric mean of 'High dose, fed: 1 FDC tablet' divided by the geometric mean of 'High dose, fed: 3 single tablets'.~The 'standard deviation' is actually the intra-individual gCV (%)."|||100.531|93.622|<0.0001
72333024|NCT00487942|144190384|SUPERIORITY_OR_OTHER||Effect size|1.62|||||TWO_SIDED|95.0|0.7|2.55||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||2.55|0.70|
72333025|NCT00487942|144190385|SUPERIORITY_OR_OTHER||Effect size|0.11|||||TWO_SIDED|95.0|-0.64|0.87||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the PANSS Total score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.87|-0.64|
72333026|NCT00487942|144190385|SUPERIORITY_OR_OTHER||Effect size|-0.11|||||TWO_SIDED|95.0|-0.87|0.64||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the PANSS Negative Scale score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.64|-0.87|
72333027|NCT00487942|144190385|SUPERIORITY_OR_OTHER||Effect size|0.73|||||TWO_SIDED|95.0|-0.08|1.54||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the PANSS Negative Scale score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||1.54|-0.08|
72333028|NCT00487942|144190386|SUPERIORITY_OR_OTHER||Effect size|-0.5|||||TWO_SIDED|95.0|-1.27|0.27||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.27|-1.27|
72423758|NCT01975220|144358143|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing.|Adjusted geometric mean ratio (%)|100.78|STANDARD_DEVIATION|4.9|<|0.0001|TWO_SIDED|90.0|98.36|103.27|||ANOVA||"The adjusted geometric mean ratio (%) was calculated as the geometric mean of 'Low dose, fasted: 2 FDC tablets' divided by the geometric mean of 'Low dose, fasted: 4 single tablets'.~The 'standard deviation' is actually the intra-individual gCV (%)."|||103.27|98.36|<0.0001
72333029|NCT00487942|144190386|SUPERIORITY_OR_OTHER||Effect size|-0.28|||||TWO_SIDED|95.0|-1.05|0.5||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.50|-1.05|
72423759|NCT01975220|144358144|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing|Adjusted geometric mean ratio (%)|109.07|STANDARD_DEVIATION|17.4||0.0072|TWO_SIDED|90.0|99.892|119.1|||ANOVA||The adjusted geometric mean ratio (%) was calculated as the geometric mean of 'High dose, fasted: 1 FDC tablet' divided by the geometric mean of 'High dose, fasted: 3 single tablets'. The 'standard deviation' is actually the intra-individual gCV (%).|||119.100|99.892|0.0072
72333030|NCT00487942|144190386|SUPERIORITY_OR_OTHER||Effect size|0.3|||||TWO_SIDED|95.0|-0.51|1.11||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||1.11|-0.51|
72333031|NCT00487942|144190387|SUPERIORITY_OR_OTHER||Effect size|-0.12|||||TWO_SIDED|95.0|-0.92|0.68||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.68|-0.92|
72333032|NCT00487942|144190387|SUPERIORITY_OR_OTHER||Effect size|0.07|||||TWO_SIDED|95.0|-0.73|0.87||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.87|-0.73|
72333033|NCT00487942|144190387|SUPERIORITY_OR_OTHER||Effect size|0.03|||||TWO_SIDED|95.0|-0.77|0.83||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.83|-0.77|
72333034|NCT00487942|144190388|SUPERIORITY_OR_OTHER||Effect size|0.0|||||TWO_SIDED|95.0|-0.8|0.8||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.80|-0.80|
72333035|NCT00487942|144190388|SUPERIORITY_OR_OTHER||Effect size|0.18|||||TWO_SIDED|95.0|-0.62|0.98||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.98|-0.62|
72423760|NCT01975220|144358144|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing|Adjusted geometric mean ratio (%)|92.42|STANDARD_DEVIATION|12.5||0.0004|TWO_SIDED|90.0|86.781|98.428|||ANOVA||"The adjusted geometric mean ratio (%) was calculated as the geometric mean of 'High dose, fed: 1 FDC tablet' divided by the geometric mean of 'High dose, fed: 3 single tablets'.~The 'standard deviation' is actually the intra-individual gCV (%)."|||98.428|86.781|0.0004
72333036|NCT00487942|144190388|SUPERIORITY_OR_OTHER||Effect size|0.66|||||TWO_SIDED|95.0|-0.16|1.49||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||1.49|-0.16|
72333037|NCT00487942|144190389|SUPERIORITY_OR_OTHER||Effect size|0.25|||||TWO_SIDED|95.0|-0.51|1.01||Inferential statistics were not performed||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the ESS Total score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||1.01|-0.51|
72333038|NCT00487942|144190389|SUPERIORITY_OR_OTHER||Effect size|0.03|||||TWO_SIDED|95.0|-0.73|0.78||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the ESS Total score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.78|-0.73|
72333039|NCT00487942|144190389|SUPERIORITY_OR_OTHER||Effect size|-0.23|||||TWO_SIDED|95.0|-1.01|0.56||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the ESS Total score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.56|-1.01|
72333040|NCT00487942|144190390|SUPERIORITY_OR_OTHER||Effect size|0.11|||||TWO_SIDED|95.0|-0.64|0.87||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.87|-0.64|
72423761|NCT01975220|144358144|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing|Adjusted geometric mean ratio (%)|105.37|STANDARD_DEVIATION|17.7||0.0014|TWO_SIDED|90.0|96.6|114.942|||ANOVA||"The adjusted geometric mean ratio (%) was calculated as the geometric mean of 'Low dose, fasted: 2 FDC tablets' divided by the geometric mean of 'Low dose, fasted: 4 single tablets'.~The 'standard deviation' is actually the intra-individual gCV (%)."|||114.942|96.600|0.0014
72333041|NCT00487942|144190390|SUPERIORITY_OR_OTHER||Effect size|-0.02|||||TWO_SIDED|95.0|-0.79|0.74||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.74|-0.79|
72333042|NCT00487942|144190390|SUPERIORITY_OR_OTHER||Effect size|-0.3|||||TWO_SIDED|95.0|-1.11|0.5||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.50|-1.11|
72333043|NCT00487942|144190391|SUPERIORITY_OR_OTHER||Effect size|-0.15|||||TWO_SIDED|95.0|-0.95|0.65||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.65|-0.95|
72333044|NCT00487942|144190391|SUPERIORITY_OR_OTHER||Effect size|-0.07|||||TWO_SIDED|95.0|-0.87|0.73||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.73|-0.87|
72333045|NCT00487942|144190391|SUPERIORITY_OR_OTHER||Effect size|-0.43|||||TWO_SIDED|95.0|-1.24|0.38||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.38|-1.24|
72333046|NCT00487942|144190392|SUPERIORITY_OR_OTHER||Effect size|0.06|||||TWO_SIDED|95.0|-0.75|0.86||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.86|-0.75|
72333047|NCT00487942|144190392|SUPERIORITY_OR_OTHER||Effect size|-0.19|||||TWO_SIDED|95.0|-0.99|0.62||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.62|-0.99|
72333048|NCT00487942|144190392|SUPERIORITY_OR_OTHER||Effect size|-0.47|||||TWO_SIDED|95.0|-1.28|0.34||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.34|-1.28|
72333049|NCT01380535|144190417|OTHER|||||||0.373|||||||Fisher Exact|||||||0.373
72333050|NCT01981863|144190421|SUPERIORITY_OR_OTHER|||||||0.21|||||||t-test, 2 sided|||||||0.21
72423762|NCT01975220|144358145|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing.|Adjusted geometric mean ratio (%)|96.65|STANDARD_DEVIATION|29.8||0.0198|TWO_SIDED|90.0|83.337|112.079|||ANOVA||The adjusted geometric mean ratio (%) was calculated as the geometric mean of 'High dose, fasted: 1 FDC tablet' divided by the geometric mean of 'High dose, fasted: 3 single tablets'. The 'standard deviation' is actually the intra-individual gCV (%).|||112.079|83.337|0.0198
72333051|NCT01971463|144190425|SUPERIORITY||||||<|0.05|||||||Wilcoxon signed rank|||Change in oCBF from baseline to post-bolus, ipsilesional hemisphere||||<0.05
72333052|NCT01971463|144190425|SUPERIORITY|Mixed effects regression, modeling the interaction term for time x normal saline bolus in the ipsilesional hemisphere|Slope|0.05|||<|0.001|TWO_SIDED|95.0|0.03|0.07|||Mixed Models Analysis|||||0.07|0.03|<0.001
72333053|NCT00420004|144190433|SUPERIORITY_OR_OTHER|||||||0.494|||||||Mixed Models Analysis|||||||0.494
72333054|NCT00664560|144190460|NON_INFERIORITY_OR_EQUIVALENCE|Non-Inferiority (NI) margin of 10mm between Arm 1 and Arm 2 (NI design uses confidence intervals, not p-values)|Mean Difference (Final Values)|-0.22|||||TWO_SIDED|95.0|-4.76|4.32|||ANCOVA|||||4.32|-4.76|
72423763|NCT01975220|144358145|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing.|Adjusted geometric mean ratio (%)|110.17|STANDARD_DEVIATION|12.0||0.0007|TWO_SIDED|90.0|103.809|116.926|||ANOVA||"The adjusted geometric mean ratio (%) was calculated as the geometric mean of 'High dose, fed: 1 FDC tablet' divided by the geometric mean of 'High dose, fed: 3 single tablets'.~The 'standard deviation' is actually the intra-individual gCV (%)."|||116.926|103.809|0.0007
72333055|NCT00664560|144190461|NON_INFERIORITY_OR_EQUIVALENCE|10 mm Non-Inferiority (NI) margin between Arm 1 and Arm 2 (NI design uses confidence intervals, not p-values)|Mean Difference (Final Values)|-0.09|||||TWO_SIDED|95.0|-4.57|4.38|||ANCOVA|||||4.38|-4.57|
72333056|NCT00664560|144190462|NON_INFERIORITY_OR_EQUIVALENCE|Non-Inferiority (NI) margin 10 mm between Arm 1 and Arm 2 (NI design uses confidence intervals, not p-values)|Mean Difference (Final Values)|-0.47|||||TWO_SIDED|95.0|-5.08|4.14|||ANCOVA|||||4.14|-5.08|
72333057|NCT02456636|144190472|SUPERIORITY||Mean Difference (Net)|-1.87||||0.025|TWO_SIDED|97.5|-3.51|-0.23|||Mixed Models Analysis|||PCMH (in clinic group counseling) versus FFS (in clinic individual counseling)||-0.23|-3.51|.025
72333058|NCT02456636|144190472|SUPERIORITY||Mean Difference (Net)|-1.36||||0.25|TWO_SIDED|97.5|-3.0|0.29|||Mixed Models Analysis|||DM (phone group counseling) versus FFS (in clinic individual counseling)||0.29|-3.00|0.25
72333059|NCT02456636|144190472|SUPERIORITY||Mean Difference (Net)|-0.51||||0.025|TWO_SIDED|97.5|-2.15|1.13|||Mixed Models Analysis|||PCMH (in clinic group visits) versus DM (phone group visits)||1.13|-2.15|.025
72333060|NCT02456636|144190473|SUPERIORITY||Median Difference (Net)|-1.84||||0.025|TWO_SIDED|97.5|-3.5|-0.18|||Mixed Models Analysis|||PCMH (in clinic group counseling) versus FFS (in clinic individual counseling).||-0.18|-3.50|.025
72423764|NCT01975220|144358145|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing.|Adjusted geometric mean ratio (%)|97.68|STANDARD_DEVIATION|23.8||0.0037|TWO_SIDED|90.0|86.942|109.734|||ANOVA||"The adjusted geometric mean ratio (%) was calculated as the geometric mean of 'Low dose, fasted: 2 FDC tablets' divided by the geometric mean of 'Low dose, fasted: 4 single tablets'.~The 'standard deviation' is actually the intra-individual gCV (%)."|||109.734|86.942|0.0037
72333061|NCT02456636|144190473|SUPERIORITY||Median Difference (Net)|-1.34||||0.025|TWO_SIDED|97.5|-2.99|0.32|||Mixed Models Analysis|||DM (phone group counseling) versus FFS (in clinic individual counseling)||0.32|-2.99|.025
72333062|NCT02456636|144190473|SUPERIORITY||Mean Difference (Net)|-0.5||||0.025|TWO_SIDED|97.5|-2.15|1.15|||Mixed Models Analysis|||PCMH (in clinic group counseling) versus DM (phone group counseling)||1.15|-2.15|.025
72333063|NCT01610557|144190498|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.3||||0.039|TWO_SIDED|95.0|0.07|2.5|||Linear mixed-effects model||The difference represents the estimated difference between ranibizumab and bevacizumab, adjusted for baseline visual acuity, study period, and clinical site and a subject effect for eyes nested within subject.|||2.5|0.07|0.039
72333064|NCT01610557|144190499|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-48.0|||<|0.001|TWO_SIDED|95.0|-65.0|-31.0|||Linear mixed-effects model||The difference represents the estimated difference between ranibizumab and bevacizumab, adjusted for baseline visual acuity, study period, and clinical site and a subject effect for eyes nested within subject.|||-31|-65|<0.001
72333065|NCT02642393|144190500|OTHER||Slope|1.256|STANDARD_ERROR_OF_MEAN|0.943||0.183|TWO_SIDED|95.0|-0.594|3.106|||Mixed Models Analysis|||||3.106|-0.594|0.183
72423765|NCT01975220|144358146|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing.|Adjusted geometric mean ratio (%)|95.4|STANDARD_DEVIATION|29.4||0.0254|TWO_SIDED|90.0|82.42|110.44|||ANOVA||The adjusted geometric mean ratio (%) was calculated as the geometric mean of 'High dose, fasted: 1 FDC tablet' divided by the geometric mean of 'High dose, fasted: 3 single tablets'. The 'standard deviation' is actually the intra-individual gCV (%).|||110.44|82.42|0.0254
72333066|NCT02642393|144190501|OTHER||Rate Ratio|1.08||||0.124|TWO_SIDED|95.0|0.979|1.192|||Poisson Regression|||||1.192|0.979|0.124
72333067|NCT02642393|144190502|OTHER||Rate Ratio|1.154||||0.004|TWO_SIDED|95.0|1.046|1.273|||Poisson Regression|||||1.273|1.046|0.004
72333068|NCT02642393|144190503|OTHER|||||||0.002|||||||Log Rank|||||||0.002
72333069|NCT02642393|144190504|OTHER|||||||0.497|||||||Log Rank|||||||0.497
72333070|NCT02642393|144190505|OTHER||Slope|-0.07|STANDARD_ERROR_OF_MEAN|0.385||0.856|TWO_SIDED|95.0|-0.825|0.685|||Mixed Models Analysis|||||0.685|-0.825|0.856
72333071|NCT02642393|144190506|OTHER||Slope|0.076|STANDARD_ERROR_OF_MEAN|0.226||0.736|TWO_SIDED|95.0|-0.368|0.521|||Mixed Models Analysis|||Anxiety||0.521|-0.368|0.736
72333072|NCT02642393|144190506|OTHER||Slope|0.295|STANDARD_ERROR_OF_MEAN|0.213||0.167|TWO_SIDED|95.0|-0.124|0.714|||Mixed Models Analysis|||Cognitive Function||0.714|-0.124|0.167
72333073|NCT02642393|144190506|OTHER||Slope|0.256|STANDARD_ERROR_OF_MEAN|0.111||0.022|TWO_SIDED|95.0|0.038|0.474|||Mixed Models Analysis|||Communication||0.474|0.038|0.022
72333074|NCT02642393|144190506|OTHER||Slope|0.095|STANDARD_ERROR_OF_MEAN|0.173||0.584|TWO_SIDED|95.0|-0.245|0.435|||Mixed Models Analysis|||Emotional and Behavioral Dyscontrol||0.435|-0.245|0.584
72333075|NCT02642393|144190506|OTHER||Slope|-0.01|STANDARD_ERROR_OF_MEAN|0.28||0.973|TWO_SIDED|95.0|-0.56|0.541|||Mixed Models Analysis|||Fatigue||0.541|-0.560|0.973
72333076|NCT02642393|144190506|OTHER||Slope|0.169|STANDARD_ERROR_OF_MEAN|0.136||0.214|TWO_SIDED|95.0|-0.098|0.437|||Mixed Models Analysis|||Lower Extremity Function||0.437|-0.098|0.214
72333077|NCT02642393|144190506|OTHER||Slope|-0.334|STANDARD_ERROR_OF_MEAN|0.304||0.271|TWO_SIDED|95.0|-0.931|0.262|||Mixed Models Analysis|||Positive Affect and Well-Being||0.262|-0.931|0.271
72333078|NCT02642393|144190506|OTHER||Slope|-0.08|STANDARD_ERROR_OF_MEAN|0.14||0.566|TWO_SIDED|95.0|-0.355|0.194|||Mixed Models Analysis|||Stigma||0.194|-0.355|0.566
72333079|NCT02642393|144190506|OTHER||Slope|0.212|STANDARD_ERROR_OF_MEAN|0.14||0.13|TWO_SIDED|95.0|-0.063|0.487|||Mixed Models Analysis|||Upper Extremity Function||0.487|-0.063|0.130
72333080|NCT02642393|144190506|OTHER||Slope|0.072|STANDARD_ERROR_OF_MEAN|0.202||0.723|TWO_SIDED|95.0|-0.325|0.468|||Mixed Models Analysis|||Sleep Disturbance||0.468|-0.325|0.723
72333081|NCT02642393|144190506|OTHER||Slope|-0.006|STANDARD_ERROR_OF_MEAN|0.298||0.984|TWO_SIDED|95.0|-0.592|0.579|||Mixed Models Analysis|||Satisfaction with Social Roles and Activities||0.579|-0.592|0.984
72333082|NCT02642393|144190506|OTHER||Slope|-0.253|STANDARD_ERROR_OF_MEAN|0.317||0.426|TWO_SIDED|95.0|-0.877|0.371|||Mixed Models Analysis|||Participation in Social Roles and Activities||0.371|-0.877|0.426
72333083|NCT02642393|144190507|OTHER||Slope|-0.106|STANDARD_ERROR_OF_MEAN|0.141||0.454|TWO_SIDED|95.0|-0.382|0.171|||Mixed Models Analysis|||||0.171|-0.382|0.454
72333084|NCT02642393|144190508|OTHER||Slope|0.047|STANDARD_ERROR_OF_MEAN|0.413||0.91|TWO_SIDED|95.0|-0.764|0.858|||Mixed Models Analysis|||||0.858|-0.764|0.910
72333085|NCT02642393|144190509|OTHER||Slope|-0.04|STANDARD_ERROR_OF_MEAN|0.13||0.758|TWO_SIDED|95.0|-0.295|0.215|||Mixed Models Analysis|||||0.215|-0.295|0.758
72333086|NCT02642393|144190510|OTHER||Slope|-0.208|STANDARD_ERROR_OF_MEAN|0.803||0.796|TWO_SIDED|95.0|-1.783|1.367|||Mixed Models Analysis|||BL to V01||1.367|-1.783|0.796
72333087|NCT02642393|144190510|OTHER||Slope|-2.4|STANDARD_ERROR_OF_MEAN|3.443||0.486|TWO_SIDED|95.0|-9.156|4.355|||Mixed Models Analysis|||V10 to SV||4.355|-9.156|0.486
72333088|NCT00365105|144190511|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.04||||0.844|TWO_SIDED|95.0|0.7|1.54|||Log Rank|||Assuming an exponential distribution, the weighted yearly SRE hazard rate for patients treated with bisphosphonates only is 0.7991 which translates to a median time to SRE of 10.4 months. The study was designed to show a 33% relative reduction in the yearly SRE hazard rate, i.e. 15.6 months median time to SRE. Using a two-sided log-rank test assuming a type I error of 0.05, one planned interim analysis with 90% statistical power, 257 SREs are required with a total of 316 patients.||1.54|0.70|0.844
72333089|NCT00365105|144190512|SUPERIORITY|The power of detecting an improvement from 55% in the control arm to 41% in the experimental arm with a two-sided Fisher's exact test at alpha 0.05 is 66%.||||||0.26|||||||Fisher Exact|||||||0.26
72333090|NCT00365105|144190513|SUPERIORITY||Hazard Ratio (HR)|1.14||||0.37|TWO_SIDED|95.0|0.86|1.52|||Log Rank|||Assuming the disease site distribution is 40%, 40%, and 20% from prostate, breast, and lung cancer populations, respectively, the weighted yearly death rate for patients treated with bisphosphonates only is 0.4390, translating to a median overall survival time of 18.9 months assuming an exponential distribution. Statistical power to detect a relative difference of 33% in the yearly death rate is 70% using a two-sided log-rank test at a 0.05 significance level and 87% to detect 50% difference.||1.52|0.86|0.37
72333091|NCT00365105|144190514|SUPERIORITY|||||||0.96||||||Two-sided significance level of 0.01|Wilcoxon (Mann-Whitney)|||FACT-G Total||||0.96
72333092|NCT00365105|144190514|SUPERIORITY|||||||0.97||||||Two-sided significance level of 0.01|Wilcoxon (Mann-Whitney)|||Physical Well-Being||||0.97
72333093|NCT00365105|144190514|SUPERIORITY|||||||0.57||||||Two-sided significance level of 0.01|Wilcoxon (Mann-Whitney)|||Social/Family Well-Being||||0.57
72333094|NCT00365105|144190514|SUPERIORITY|||||||0.7||||||Two-sided significance level of 0.01|Wilcoxon (Mann-Whitney)|||Emotional Well-Being||||0.70
72333095|NCT00365105|144190514|SUPERIORITY|||||||0.46||||||Two-sided significance level of 0.01|Wilcoxon (Mann-Whitney)|||Functional Well-Being||||0.46
72333096|NCT00365105|144190515|SUPERIORITY|||||||0.99||||||2-sided significance level of 0.05|Wilcoxon (Mann-Whitney)|||||||0.99
72333097|NCT00365105|144190516|SUPERIORITY|||||||0.43||||||Significance level of 0.05|t-test, 2 sided|||Index Score||||0.43
72333098|NCT00365105|144190516|SUPERIORITY|||||||0.15||||||Significance level of 0.05|t-test, 2 sided|||VAS Score||||0.15
72333099|NCT00608023|144190517|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||ANCOVA|||||||<0.001
72333100|NCT00608023|144190518|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|||||||ANCOVA|||||||>0.05
72333101|NCT00608023|144190519|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|||||||ANCOVA|||||||>0.05
72333102|NCT00608023|144190520|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|||||||ANCOVA|||||||>0.05
72333103|NCT00608023|144190521|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|||||||ANCOVA|||||||>0.05
72333104|NCT04478071|144190540|SUPERIORITY||Risk Difference (RD)|-0.036|||||TWO_SIDED|95.0|-0.084|0.009|||||"Risk difference of Vadadustat relative to Placebo. Values under confidence interval reflect Bayesian 95% credible interval rather than frequentist confidence interval."|Trial used Bayesian analysis for superiority. Hypothesis Testing for Primary Outcome: Among adult hospital admissions with lab-confirmed diagnosis of COVID-19, vadadustat 900 mg will demonstrate superiority to placebo as defined by a lower probability, at treatment day 14, of death (8) or hospitalization, on invasive mechanical ventilation or ECMO (7) or hospitalization, on non-invasive ventilation or high flow oxygen devices (6) on the NIAID-OS. See Statistical Analysis Plan for more details.||0.009|-0.084|
72333105|NCT04478071|144190540|SUPERIORITY||Posterior Probability|0.94|||||TWO_SIDED||||||||Posterior probability of the risk difference of Vadadustat relative to Placebo.|||||
72333106|NCT04478071|144190541|SUPERIORITY||Risk Ratio (RR)|1.01|||||TWO_SIDED|95.0|0.92|1.1|||||"Risk ratio of Vadadustat relative to Placebo. Values under confidence interval reflect Bayesian 95% credible interval rather than frequentist confidence interval."|Trial used Bayesian analysis for superiority. Hypothesis Testing for Secondary Outcome: Among adult hospital admissions with lab-confirmed diagnosis of COVID-19, vadadustat 900 mg will demonstrate superiority to placebo as defined by a higher probability, at treatment day 14, of recovery on the MSOFA scale (MSOFA = 0).||1.1|0.92|
72333107|NCT04478071|144190541|SUPERIORITY||Posterior probability|0.57|||||TWO_SIDED||||||||Posterior probability of the risk ratio of Vadadustat relative to Placebo.|||||
72333108|NCT06053541|144190553|OTHER|||||||0.24|||||||Wilcoxon (Mann-Whitney)|||For the evaluation of statistical significance, considering that the data do not follow a normal distribution and that the two samples are independent and not paired, the Mann-Whitney test was applied and a p value \< 0.05 was considered.||||0.24
72333109|NCT06053541|144190554|OTHER|||||||0.37|||||||Wilcoxon (Mann-Whitney)|||For the evaluation of statistical significance, considering that the data do not follow a normal distribution and that the two samples are independent and not paired, the Mann-Whitney test was applied and a p value \< 0.05 was considered.||||0.37
72333110|NCT06053541|144190555|OTHER|||||||0.03|||||||Wilcoxon (Mann-Whitney)|||For the evaluation of statistical significance, considering that the data do not follow a normal distribution and that the two samples are independent and not paired, the Mann-Whitney test was applied and a p value \< 0.05 was considered.||||0.03
72333111|NCT06053541|144190556|OTHER|||||||0.11|||||||Wilcoxon (Mann-Whitney)|||Beds in the general practice and Pulmonology: For the evaluation of statistical significance, considering that the data do not follow a normal distribution and that the two samples are independent and not paired, the Mann-Whitney test was applied and a p value \< 0.05 was considered.||||0.11
72333112|NCT06053541|144190556|OTHER||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||Beds in Adults ICU: For the evaluation of statistical significance, considering that the data do not follow a normal distribution and that the two samples are independent and not paired, the Mann-Whitney test was applied and a p value \< 0.05 was considered.||||<0.01
72333113|NCT06053541|144190557|OTHER|||||||0.01|||||||Wilcoxon (Mann-Whitney)|||For the evaluation of statistical significance, considering that the data do not follow a normal distribution and that the two samples are independent and not paired, the Mann-Whitney test was applied and a p value \< 0.05 was considered.||||0.01
72333114|NCT06053541|144190558|OTHER|||||||0.07|||||||Wilcoxon (Mann-Whitney)|||For the evaluation of statistical significance, considering that the data do not follow a normal distribution and that the two samples are independent and not paired, the Mann-Whitney test was applied and a p value \< 0.05 was considered.||||0.07
72333115|NCT00245050|144190559|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.07|||<|0.05|TWO_SIDED|95.0|0.536|2.16|||Chi-squared|||Based on published literature, it is estimated that the incidence of HFS for all grades is 49%. A decrease of 50% or more in the incidence of HFS in patients receiving pyridoxine would be of clinical significance. A sample size of 27 patients per group was chosen as this would allow us to detect a difference between HFS incidence of 49% and 11.5% (alpha=0.05, two-sided, power=0.80). Interim analysis was conducted after 30 patients were enrolled and had evaluable HFS assessment data.||2.16|0.536|<0.05
72333116|NCT00245050|144190560|SUPERIORITY_OR_OTHER|||||||0.916||95.0|||||t-test, 2 sided|||||||0.916
72333117|NCT00425698|144190561|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.0|STANDARD_DEVIATION|15.0|<|0.05|TWO_SIDED|95.0|||||t-test, 2 sided|||Null hypothesis: Erythopoietin significantly improves kidney graft function. Power calculation: with a difference of at least 4 mL/min in mean eGFR between groups the number of patients enrolled per group (at least 41) would allowed the detection of a significant difference between groups at a 5% level (p\<0.05)||||<0.05
72333118|NCT02516098|144190579|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence of the test and reference product (for Stage 1) was assessed on the basis of the point estimate of the geometric mean ratio for Cmax in relation to the bioequivalence range of 80.00% to 125.00%.|Geometric mean ratio (%): T/REF|87.52|||||TWO_SIDED|92.46|77.18|99.24|||||ANOVA model was used with 'sequence', 'treatment' and 'period' as fixed effects and 'subject within sequence' as a random effect after logarithmic transformation of the data.|The study design is a two-stage Pocock-like group sequential design according to the alpha spending function approach. The alpha level for Stage 1 was 0.0377 (one-sided).||99.24|77.18|
72333119|NCT02516098|144190580|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence of the test and reference products for Stage 1 was assessed on the basis of the 92.46% confidence intervals for the geometric mean (test/reference) ratio for the AUC0-t in relation to the bioequivalence range of 80.00% to 125.00%, with a one-sided alpha of 0.0377.|Geometric mean ratio (%): T/REF|91.74|||||TWO_SIDED|92.46|83.51|100.78|||||ANOVA model was used with 'sequence', 'treatment' and 'period' as fixed effects and 'subject within sequence' as a random effect after logarithmic transformation of the data.|The study design is a two-stage Pocock-like group sequential design according to the alpha spending function approach. The alpha level for Stage 1 was 0.0377 (one-sided).||100.78|83.51|
72333120|NCT02516098|144190581|SUPERIORITY_OR_OTHER||Geometric mean ratio (%): T/REF|91.66|||||TWO_SIDED|92.46|83.59|100.51|||||ANOVA model was used with 'sequence', 'treatment' and 'period' as fixed effects and 'subject within sequence' as a random effect after logarithmic transformation of the data.|The test product was compared to the reference product by means of statistical analysis.||100.51|83.59|
72333121|NCT02516098|144190582|SUPERIORITY_OR_OTHER||Geometric mean ratio (%): T/REF|92.96|||||TWO_SIDED|92.46|81.94|105.47|||||ANOVA model was used with 'sequence', 'treatment' and 'period' as fixed effects and 'subject within sequence' as a random effect after logarithmic transformation of the data.|The test product was compared to the reference product by means of statistical analysis.||105.47|81.94|
72333122|NCT01973387|144190583|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.178|||<|0.0001|TWO_SIDED|95.0|0.109|0.291|||Log Rank|||||0.291|0.109|<0.0001
72333123|NCT01562314|144190593|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.821||||0.7532|TWO_SIDED|90.0|0.292|2.309|||Regression, Logistic|||||2.309|0.292|0.7532
72333124|NCT01562314|144190594|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.3||||0.7032|TWO_SIDED|90.0|0.419|4.04|||Regression, Logistic|||||4.040|0.419|0.7032
72333125|NCT02512874|144190614|SUPERIORITY|||||||0.62|||||||Chi-squared|||||||0.62
72333126|NCT03888235|144190632|SUPERIORITY|||||||0.003|||||||Kruskal-Wallis|||The null hypothesis assumes that after one month, there is no difference in Oswestry low back pain and disability score improvement between the three treatment groups.||||0.003
72333127|NCT03888235|144190632|SUPERIORITY|||||||0.001||||||SI Exercise versus usual care. Bonferroni alpha correction p\< 0.0167|Wilcoxon (Mann-Whitney)|||||||0.001
72333128|NCT03888235|144190632|SUPERIORITY|||||||0.314|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: there is no difference in Oswestry low back pain and disability score between those using a pelvic support belt and those using usual treatment||||0.314
72333129|NCT03888235|144190633|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|||Oswestry low back pain and disability (ODI) score change over two months for all participants. This compares the score at initial visit and the score 2 months later after all participants have been using the corrective exercise and sacroiliac stabilization belt for one month. =(ODI time 0 - ODI 2 months). The greater the difference, the better the recovery of back function.||||< 0.001
72333130|NCT03888235|144190634|SUPERIORITY|||||||0.17|||||||Kruskal-Wallis|||The null hypothesis assumes that after one month, there is no difference in brief pain inventory score improvement between the three treatment groups.||||0.17
72333131|NCT03888235|144190634|SUPERIORITY|||||||0.089||||||Bonferroni alpha correction of p\<0.0167.|Wilcoxon (Mann-Whitney)|||The brief pain inventory score at the one month visit, is used to compare the pain levels of those having done one month of corrective exercises to those who continued with conventional treatments for their low back pain.||||0.089
72423766|NCT01975220|144358146|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing.|Adjusted geometric mean ratio (%)|99.63|STANDARD_DEVIATION|7.1|<|0.0001|TWO_SIDED|90.0|96.21|103.17|||ANOVA||"The adjusted geometric mean ratio (%) was calculated as the geometric mean of 'High dose, fed: 1 FDC tablet' divided by the geometric mean of 'High dose, fed: 3 single tablets'.~The 'standard deviation' is actually the intra-individual gCV (%)."|||103.17|96.21|<0.0001
72333132|NCT03888235|144190634|SUPERIORITY|||||||0.092|||||||Wilcoxon (Mann-Whitney)|||The brief pain inventory score is used to compare those using a pelvic support belt for one month and those with delayed treatment||||0.092
72333133|NCT03888235|144190635|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|||All participants are assessed as a single group as they receive the same two treatments for one month. Brief pain inventory (BPI) score change over two months for all participants. This compares BPI score at baseline visit and BPI score 2 months later, after all participants have been using the corrective exercise and sacroiliac stabilization belt for one month. The score is between 0 and 10. The higher the change in score the greater the pain relief.||||< 0.001
72333134|NCT03888235|144190636|SUPERIORITY|||||||0.016||||||The Bonferroni alpha correction is used p\<0.0167|Kruskal-Wallis|||The null hypothesis assumes there is no improvement after one month in posterior superior iliac spine levels (PSISL) measured using the sacroiliac forward flexion test (SIFFT) between the three treatment groups.||||0.016
72333135|NCT03888235|144190636|SUPERIORITY|||||||0.009||||||The Bonferroni alpha correction is used p\<0.0167|Wilcoxon (Mann-Whitney)|||The null hypothesis is that there is no difference in the distance between the posterior sacroiliac spine levels (PSISL) between those who use their usual low back pain treatments and those who are given the corrective exercises (SIFFTE) and use them as needed for one month.||||0.009
72333136|NCT03888235|144190636|SUPERIORITY|||||||0.034||||||Bonferroni correction p\< 0.0167|Wilcoxon (Mann-Whitney)|||The null hypothesis is that that using a pelvic support belt will not help correct sacroiliac joint asymmetry as measured using the distance between the posterior superior iliac spine levels (PSISL), baseline and one month later better than conventional treatment for low back pain.||||0.034
72333137|NCT03888235|144190637|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||Since all participants have received the same 2 treatment for one month, we will treat them as a single group. We will measure the distance between their posterior superior iliac spine levels (PSISL) when they enter the study and two months later after they have used the corrective exercise and the sacroiliac belt for one month. Corona prevented some participants from returning for examination, which this test requires. Only 11 participants were present in each group: 33 participants tested.||||< 0.0001
72333138|NCT03888235|144190637|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|||||||< 0.001
72333139|NCT03888235|144190638|SUPERIORITY||||||<|1e-05|||||||t-test, 2 sided|||the null hypothesis is that all participants were as satisfied with the physiotherapy as they were with using the corrective exercises and the pelvic stabilization belt||||<0.00001
72333140|NCT03888235|144190639|SUPERIORITY||||||<|1e-05|||||||t-test, 2 sided|||the null hypothesis is that all participants were as satisfied with the acupuncture as they were with using the corrective exercises and the pelvic stabilization belt||||<0.00001
72333141|NCT03888235|144190640|SUPERIORITY||||||<|1e-05|||||||t-test, 2 sided|||The null hypothesis is that all participants were as satisfied with the yoga exercises as they were with using the corrective exercises and the pelvic stabilization belt||||<0.00001
72333142|NCT03888235|144190641|SUPERIORITY||||||<|1e-05|||||||t-test, 2 sided|||the null hypothesis is that all participants were as satisfied with the core exercises as they were with using the corrective exercise and the pelvic stabilization belt||||<0.00001
72333143|NCT03888235|144190642|SUPERIORITY||||||<|1e-05|||||||t-test, 2 sided|||the null hypothesis is that all participants were as satisfied with treatments by a chiropractor as they were with using the corrective exercise and the pelvic stabilization belt||||<0.00001
72333144|NCT03888235|144190643|SUPERIORITY||||||<|1e-05|||||||t-test, 2 sided|||The null hypothesis is that all participants were as satisfied with massage therapy as they were with using the corrective exercise and the pelvic stabilization belt.||||<0.00001
72333145|NCT02357472|144190644|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Sample Size to Achieve 0.80 Power to Test Equivalency at the α = 0.05 Significance Level for True Proportions|Mean Difference (Final Values)|1.31|STANDARD_ERROR_OF_MEAN|1.31||0.0003|TWO_SIDED|95.0|0.6216|2.002|||t-test, 2 sided|||It was caculated that 60 paticipants randomized in a 1:1between 2 arms would would have at least 85% power to detect a difference of 1.32 oocytes between the high dose group and standard dose group after 12 weeks.Sample size was determined using 2 sided 2 sample t-test (α = 0.05).Assumptions included a common standard deviation of 1.72.||2.002|0.6216|0.0003
72333146|NCT02135029|144190658|SUPERIORITY_OR_OTHER||Least Square (LS) Mean Difference|-54.5|STANDARD_ERROR_OF_MEAN|2.82|<|0.001|TWO_SIDED|95.0|-60.1|-49.0|||MMRM|Mixed Model Repeated Measures (MMRM)|LS-mean differences,associated 95% confidence interval (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit,treatment group\*visit interaction,baseline value, baseline value\*visit\*group interaction, country.|||-49.0|-60.1|<0.001
72333147|NCT02135029|144190659|SUPERIORITY_OR_OTHER||LS Mean Difference|-38.4|STANDARD_ERROR_OF_MEAN|2.13|<|0.001|TWO_SIDED|95.0|-42.6|-34.2|||MMRM||LS-mean differences, associated 95% CI, and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\* visit interaction, baseline value, baseline value\* visit\* group interaction, country.|Week 12||-34.2|-42.6|<0.001
72333148|NCT02135029|144190659|SUPERIORITY_OR_OTHER||LS Mean Difference|-31.0|STANDARD_ERROR_OF_MEAN|2.47|||TWO_SIDED|95.0|-35.9|-26.2|||||LS-mean differences, associated 95% CI, for treatment group, visit, treatment group\* visit interaction, baseline value, baseline value\* visit\* group interaction, country.|Week 24||-26.2|-35.9|
72333149|NCT02135029|144190660|SUPERIORITY_OR_OTHER||LS Mean Difference|-46.5|STANDARD_ERROR_OF_MEAN|2.72|<|0.001|TWO_SIDED|95.0|-51.9|-41.1|||MMRM||LS-mean differences, associated 95% CI, and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\* visit interaction, baseline value, baseline value\* visit\* group interaction, country.|Week 12||-41.1|-51.9|<0.001
72333150|NCT02135029|144190660|SUPERIORITY_OR_OTHER||LS Mean Difference|-39.3|STANDARD_ERROR_OF_MEAN|3.1|||TWO_SIDED|95.0|-45.4|-33.2|||||LS-mean differences, associated 95% CI, for treatment group, visit, treatment group\* visit interaction, baseline value, baseline value\* visit\* group interaction, country.|Week 24||-33.2|-45.4|
72333151|NCT02135029|144190661|SUPERIORITY_OR_OTHER||LS Mean Difference|-51.2|STANDARD_ERROR_OF_MEAN|2.61|<|0.001|TWO_SIDED|95.0|-56.3|-46.0|||MMRM||LS-mean differences, associated 95% CI, and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\* visit interaction, baseline value, baseline value\* visit\* group interaction, country.|Week 12||-46.0|-56.3|<0.001
72333152|NCT02135029|144190661|SUPERIORITY_OR_OTHER||LS Mean Difference|-41.8|STANDARD_ERROR_OF_MEAN|3.02|||TWO_SIDED|95.0|-47.7|-35.8|||||LS-mean differences, associated 95% CI, for treatment group, visit, treatment group\* visit interaction, baseline value, baseline value\* visit\* group interaction, country.|Week 24||-35.8|-47.7|
72333153|NCT02135029|144190662|SUPERIORITY_OR_OTHER||LS Mean Difference|-23.3|STANDARD_ERROR_OF_MEAN|6.32|<|0.001|TWO_SIDED|95.0|-35.7|-10.8|||MMRM||LS-mean differences, associated 95% CI, and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\* visit interaction, baseline value, baseline value\* visit\* group interaction, country.|Week 12||-10.8|-35.7|<0.001
72333154|NCT02135029|144190662|SUPERIORITY_OR_OTHER||LS Mean Difference|-17.4|STANDARD_ERROR_OF_MEAN|6.21|||TWO_SIDED|95.0|-29.6|-5.1|||||LS-mean differences, associated 95% CI, for treatment group, visit, treatment group\* visit interaction, baseline value, baseline value\* visit\* group interaction, country.|Week 24||-5.1|-29.6|
72333155|NCT02135029|144190663|SUPERIORITY_OR_OTHER||LS Mean Difference|12.4|STANDARD_ERROR_OF_MEAN|2.34|<|0.001|TWO_SIDED|95.0|7.8|17.0|||MMRM||LS-mean differences, associated 95% CI, and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\* visit interaction, baseline value, baseline value\* visit\* group interaction, country.|Week 12||17.0|7.8|<0.001
72333156|NCT02135029|144190663|SUPERIORITY_OR_OTHER||LS Mean Difference|11.5|STANDARD_ERROR_OF_MEAN|2.47|||TWO_SIDED|95.0|6.7|16.4|||||LS-mean differences, associated 95% CI, for treatment group, visit, treatment group\* visit interaction, baseline value, baseline value\* visit\* group interaction, country.|Week 24||16.4|6.7|
72423767|NCT01975220|144358146|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing.|Adjusted geometric mean ratio (%)|101.06|STANDARD_DEVIATION|24.4||0.0029|TWO_SIDED|90.0|89.7|113.86|||ANOVA||"The adjusted geometric mean ratio (%) was calculated as the geometric mean of 'Low dose, fasted: 2 FDC tablets' divided by the geometric mean of 'Low dose, fasted: 4 single tablets'.~The 'standard deviation' is actually the intra-individual gCV (%)."|||113.86|89.70|0.0029
72423768|NCT04064242|144358178|OTHER|A Bayesian model for repeated measurements including data collected at Weeks 4, 8, 12 and 16 was applied to compare FVC between CMK389 and placebo groups.|Posterior estimate treatment difference|-1.49|STANDARD_DEVIATION|1.62||0.1804|TWO_SIDED|80.0|-3.56|0.6|||Bayesian analysis|Posterior probability that treatment is better than placebo.|80% credible intervals are reported on the treatment difference|||0.60|-3.56|0.1804
72333157|NCT02135029|144190664|SUPERIORITY_OR_OTHER||LS Mean Difference|-44.8|STANDARD_ERROR_OF_MEAN|3.33|||TWO_SIDED|95.0|-51.3|-38.2|||||LS-mean differences, associated 95% CI, for treatment group, visit, treatment group\* visit interaction, baseline value, baseline value\* visit\* group interaction, country.|Week 24||-38.2|-51.3|
72333158|NCT02135029|144190665|SUPERIORITY_OR_OTHER||LS Mean Difference|-14.3|STANDARD_ERROR_OF_MEAN|4.67|||TWO_SIDED|95.0|-23.5|-5.2|||||LS-mean differences, associated 95% CI, for treatment group, visit, treatment group\* visit interaction, baseline value, baseline value\* visit\* group interaction, country.|Week 12||-5.2|-23.5|
72333159|NCT02135029|144190665|SUPERIORITY_OR_OTHER||LS Mean Difference|-9.7|STANDARD_ERROR_OF_MEAN|5.14|||TWO_SIDED|95.0|-19.8|0.4|||||LS-mean differences, associated 95% CI, for treatment group, visit, treatment group\* visit interaction, baseline value, baseline value\* visit\* group interaction, country.|Week 24||0.4|-19.8|
72333160|NCT02135029|144190666|SUPERIORITY_OR_OTHER||LS Mean Difference|6.1|STANDARD_ERROR_OF_MEAN|2.0|||TWO_SIDED|95.0|2.2|10.1|||||LS-mean differences, associated 95% CI, for treatment group, visit, treatment group\* visit interaction, baseline value, baseline value\* visit\* group interaction, country.|Week 12||10.1|2.2|
72423769|NCT04064242|144358184|SUPERIORITY||Median Difference (Net)|-0.04|STANDARD_ERROR_OF_MEAN|0.045||0.783|TWO_SIDED|80.0|-0.09|0.02|||Mixed effects Model for Repeated Measure||Treatment difference (CMK389-placebo)|||0.02|-0.09|0.783
72423770|NCT04064242|144358185|SUPERIORITY||Mean Difference (Net)|-0.18|STANDARD_ERROR_OF_MEAN|0.664||0.608|TWO_SIDED|80.0|-1.05|0.68|||Mixed effects Model for Repeated Measure||Treatment difference (CMK389-placebo)|||0.68|-1.05|0.608
72333161|NCT02135029|144190666|SUPERIORITY_OR_OTHER||LS Mean Difference|5.6|STANDARD_ERROR_OF_MEAN|2.09|||TWO_SIDED|95.0|1.5|9.7|||||LS-mean differences, associated 95% CI, for treatment group, visit, treatment group\* visit interaction, baseline value, baseline value\* visit\* group interaction, country.|Week 24||9.7|1.5|
72333162|NCT02135029|144190667|SUPERIORITY_OR_OTHER||LS Mean Difference|4.7|STANDARD_ERROR_OF_MEAN|2.02|||TWO_SIDED|95.0|0.8|8.7|||||LS-mean differences, associated 95% CI, for treatment group, visit, treatment group\* visit interaction, baseline value, baseline value\* visit\* group interaction, country.|Week 12||8.7|0.8|
72333163|NCT02135029|144190667|SUPERIORITY_OR_OTHER||LS Mean Difference|6.5|STANDARD_ERROR_OF_MEAN|2.07|||TWO_SIDED|95.0|2.4|10.5|||||LS-mean differences, associated 95% CI, for treatment group, visit, treatment group\* visit interaction, baseline value, baseline value\* visit\* group interaction, country.|Week 24||10.5|2.4|
72333164|NCT02135029|144190668|SUPERIORITY_OR_OTHER||LS Mean Difference|-14.3|STANDARD_ERROR_OF_MEAN|4.67|||TWO_SIDED|95.0|-23.5|-5.2|||||LS-mean differences, associated 95% CI, for treatment group, visit, treatment group\* visit interaction, baseline value, baseline value\* visit\* group interaction, country.|Week 12||-5.2|-23.5|
72333165|NCT02135029|144190668|SUPERIORITY_OR_OTHER||LS Mean Difference|-9.7|STANDARD_ERROR_OF_MEAN|5.14|||TWO_SIDED|95.0|-19.8|0.4|||||LS-mean differences, associated 95% CI, for treatment group, visit, treatment group\* visit interaction, baseline value, baseline value\* visit\* group interaction, country.|Week 24||0.4|-19.8|
72333166|NCT02135029|144190669|SUPERIORITY_OR_OTHER||LS Mean Difference|-93.8|STANDARD_ERROR_OF_MEAN|4.93|||TWO_SIDED|95.0|-103.5|-84.1|||||LS-mean differences, associated 95% CI, for treatment group, visit, treatment group\* visit interaction, baseline value, baseline value\* visit\* group interaction, country.|Week 12||-84.1|-103.5|
72333167|NCT02135029|144190670|SUPERIORITY_OR_OTHER||LS Mean Difference|-98.7|STANDARD_ERROR_OF_MEAN|5.67|||TWO_SIDED|95.0|-109.9|-87.5|||||LS-mean differences, associated 95% CI, for treatment group, visit, treatment group\* visit interaction, baseline value, baseline value\* visit\* group interaction, country.|Week 12||-87.5|-109.9|
72333168|NCT02135029|144190671|SUPERIORITY_OR_OTHER||LS Mean Difference|5.9|STANDARD_ERROR_OF_MEAN|1.11|||TWO_SIDED|95.0|3.7|8.0|||||LS-mean differences, associated 95% CI, for treatment group, visit, treatment group\* visit interaction, baseline value, baseline value\* visit\* group interaction, country.|Week 12||8.0|3.7|
72333169|NCT02135029|144190672|SUPERIORITY_OR_OTHER||LS Mean Difference|-103.6|STANDARD_ERROR_OF_MEAN|5.56|||TWO_SIDED|95.0|-114.6|-92.7|||||LS-mean differences, associated 95% CI, for treatment group, visit, treatment group\* visit interaction, baseline value, baseline value\* visit\* group interaction, country.|Week 12||-92.7|-114.6|
72333170|NCT02135029|144190674|SUPERIORITY_OR_OTHER||LS Mean Difference|-59.2|STANDARD_ERROR_OF_MEAN|3.46|||TWO_SIDED|95.0|-66.0|-52.4|||||LS-mean differences, associated 95% CI, for treatment group, visit, treatment group\* visit interaction, baseline value, baseline value\* visit\* group interaction, country.|Week 12||-52.4|-66.0|
72333171|NCT02135029|144190675|SUPERIORITY_OR_OTHER||LS Mean Difference|-6.6|STANDARD_ERROR_OF_MEAN|1.06|||TWO_SIDED|95.0|-8.7|-4.5|||||LS-mean differences, associated 95% CI, for treatment group, visit, treatment group\* visit interaction, baseline value, baseline value\* visit\* group interaction, country.|Week 12||-4.5|-8.7|
72333172|NCT02135029|144190676|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.4|STANDARD_ERROR_OF_MEAN|0.15|||TWO_SIDED|95.0|-2.7|-2.1|||||LS-mean differences, associated 95% CI, for treatment group, visit, treatment group\* visit interaction, baseline value, baseline value\* visit\* group interaction, country.|Week 12||-2.1|-2.7|
72333173|NCT02135029|144190676|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.1|STANDARD_ERROR_OF_MEAN|0.16|||TWO_SIDED|95.0|-2.4|-1.7|||||LS-mean differences, associated 95% CI, for treatment group, visit, treatment group\* visit interaction, baseline value, baseline value\* visit\* group interaction, country.|Week 24||-1.7|-2.4|
72333174|NCT02135029|144190677|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.03|||TWO_SIDED|95.0|-0.5|-0.4|||||LS-mean differences, associated 95% CI, for treatment group, visit, treatment group\* visit interaction, baseline value, baseline value\* visit\* group interaction, country.|Week 12||-0.4|-0.5|
72333175|NCT02135029|144190677|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.03|||TWO_SIDED|95.0|-0.4|-0.3|||||LS-mean differences, associated 95% CI, for treatment group, visit, treatment group\* visit interaction, baseline value, baseline value\* visit\* group interaction, country.|Week 24||-0.3|-0.4|
72333176|NCT03525600|144190685|SUPERIORITY||LS Mean Difference|-0.2296||||0.0615|TWO_SIDED|95.0|-0.4703|0.0111|||MMRM model|||Model included treatment + baseline GA lesion area (\<7.5 mm\^2 or ≥7.5 mm\^2) + analysis visit + presence of choroidal neovascularization (CNV) in the fellow eye (yes or no) + analysis visit × treatment + baseline GA lesion area × analysis visit.||0.0111|-0.4703|0.0615
72333177|NCT03525600|144190685|SUPERIORITY||LS Mean Difference|-0.2077||||0.0854|TWO_SIDED|95.0|-0.4444|0.029|||MMRM model|||Model included treatment + baseline GA lesion area (\<7.5 mm\^2 or ≥7.5 mm\^2) + analysis visit + presence of CNV in the fellow eye (yes or no) + analysis visit × treatment + baseline GA lesion area × analysis visit.||0.0290|-0.4444|0.0854
72333178|NCT03525600|144190686|SUPERIORITY||LS Mean Difference|-0.7451||||0.0004|TWO_SIDED|95.0|-1.1539|-0.3362|||MMRM model|||Model included treatment + baseline GA lesion area (\<7.5 mm\^2 or ≥7.5 mm\^2) + analysis visit + baseline presence of CNV in the fellow eye (yes or no) + analysis visit × treatment + baseline GA lesion area (\<7.5 mm\^2 or ≥7.5 mm\^2) × analysis visit.||-0.3362|-1.1539|0.0004
72333179|NCT03525600|144190686|SUPERIORITY||LS Mean Difference|-0.6331||||0.003|TWO_SIDED|95.0|-1.0508|-0.2153|||MMRM model|||Model included treatment + baseline GA lesion area (\<7.5 mm\^2 or ≥7.5 mm\^2) + analysis visit + baseline presence of CNV in the fellow eye (yes or no) + analysis visit × treatment + baseline GA lesion area (\<7.5 mm\^2 or ≥7.5 mm\^2) × analysis visit.||-0.2153|-1.0508|0.0030
72333180|NCT03525600|144190687|SUPERIORITY|Baseline GA lesion area x Time (continuous) + Baseline GA lesion area x Time Spline at Month 6 (continuous) + Baseline GA lesion area x Time Spline at Month 12 (continuous) + Baseline GA lesion area x Time Spline at Month 18 (continuous). A heterogeneous autoregressive covariance matrix was used to model within-subject errors.|Mean Difference|-0.0547||||0.4282|TWO_SIDED|95.0|-0.1899|0.0806|||MMRM model|||Estimates for Baseline to Month 6: Model included Treatment + Baseline GA lesion area (\< 7.5 mm\^2 or \>= 7.5 mm\^2) + Time (continuous) + Time Spline at Month 6 (continuous) + Time Spline at Month 12 (continuous) + Time Spline at Month 18 (continuous) + Presence of CNV in the fellow eye (Yes or No) + Time (continuous) x Treatment + Time Spline at Month 6 (continuous) x Treatment + Time Spline at Month 12 (continuous) x Treatment + Time Spline at Month 18 (continuous) x Treatment +||0.0806|-0.1899|0.4282
72369031|NCT02446899|144248020|SUPERIORITY||Rate Ratio|0.67||||0.0809|TWO_SIDED|95.0|0.48|0.94||Adjusted p-value.|Negative binomial regression|||Analysed using a negative binomial regression model. The response variable in the model is the number of flares over the 52-week treatment period. The model includes covariates of treatment group, and the stratification factors (SLEDAI-2K score at screening \[\<10 points vs \>=10 points\], Week 0 OCS dose \[\<10 mg/day vs \>=10 mg/day prednisone or equivalent\] and type I IFN gene signature test result at screening \[high vs low\]). The logarithm of the follow-up time is used as an offset variable.||0.94|0.48|0.0809
72369032|NCT04050202|144248025|OTHER||Mean Difference (Net)|8.45|||<|0.01|TWO_SIDED||||||t-test, 2 sided||The post-intervention score is subtracted from the baseline score.|||||<0.01
72369033|NCT04050202|144248026|OTHER||Mean Difference (Net)|13.97|||<|0.01|TWO_SIDED||||||t-test, 2 sided||The post-intervention score is subtracted from the baseline score|||||<0.01
72423771|NCT04064242|144358186|SUPERIORITY||Median Difference (Net)|0.71|STANDARD_ERROR_OF_MEAN|13.126||0.479|TWO_SIDED|80.0|-16.35|17.76|||Mixed effects Model for Repeated Measure||Treatment difference (CMK389-placebo)|||17.76|-16.35|0.479
72333181|NCT03525600|144190687|SUPERIORITY|Baseline GA lesion area x Time (continuous) + Baseline GA lesion area x Time Spline at Month 6 (continuous) + Baseline GA lesion area x Time Spline at Month 12 (continuous) + Baseline GA lesion area x Time Spline at Month 18 (continuous). A heterogeneous autoregressive covariance matrix was used to model within-subject errors.|Mean Difference|-0.0793||||0.2457|TWO_SIDED|95.0|-0.2131|0.0546|||MMRM model|||Estimates for Baseline to Month 6: Model included Treatment + Baseline GA lesion area (\< 7.5 mm\^2 or \>= 7.5 mm\^2) + Time (continuous) + Time Spline at Month 6 (continuous) + Time Spline at Month 12 (continuous) + Time Spline at Month 18 (continuous) + Presence of CNV in the fellow eye (Yes or No) + Time (continuous) x Treatment + Time Spline at Month 6 (continuous) x Treatment + Time Spline at Month 12 (continuous) x Treatment + Time Spline at Month 18 (continuous) x Treatment +||0.0546|-0.2131|0.2457
72333182|NCT03525600|144190687|SUPERIORITY|Baseline GA lesion area x Time (continuous) + Baseline GA lesion area x Time Spline at Month 6 (continuous) + Baseline GA lesion area x Time Spline at Month 12 (continuous) + Baseline GA lesion area x Time Spline at Month 18 (continuous). A heterogeneous autoregressive covariance matrix was used to model within-subject errors.|Mean Difference|-0.1722||||0.0292|TWO_SIDED|95.0|-0.327|-0.0174|||MMRM model|||Estimates for Month 6 to Month 12: Model included Treatment + Baseline GA lesion area (\< 7.5 mm\^2 or \>= 7.5 mm\^2) + Time (continuous) + Time Spline at Month 6 (continuous) + Time Spline at Month 12 (continuous) + Time Spline at Month 18 (continuous) + Presence of CNV in the fellow eye (Yes or No) + Time (continuous) x Treatment + Time Spline at Month 6 (continuous) x Treatment + Time Spline at Month 12 (continuous) x Treatment + Time Spline at Month 18 (continuous) x Treatment +||-0.0174|-0.3270|0.0292
72333183|NCT03525600|144190687|SUPERIORITY|Baseline GA lesion area x Time (continuous) + Baseline GA lesion area x Time Spline at Month 6 (continuous) + Baseline GA lesion area x Time Spline at Month 12 (continuous) + Baseline GA lesion area x Time Spline at Month 18 (continuous). A heterogeneous autoregressive covariance matrix was used to model within-subject errors.|Mean Difference|-0.1659||||0.0352|TWO_SIDED|95.0|-0.3202|-0.0115|||MMRM model|||Estimates for Month 6 to Month 12: Model included Treatment + Baseline GA lesion area (\< 7.5 mm\^2 or \>= 7.5 mm\^2) + Time (continuous) + Time Spline at Month 6 (continuous) + Time Spline at Month 12 (continuous) + Time Spline at Month 18 (continuous) + Presence of CNV in the fellow eye (Yes or No) + Time (continuous) x Treatment + Time Spline at Month 6 (continuous) x Treatment + Time Spline at Month 12 (continuous) x Treatment + Time Spline at Month 18 (continuous) x Treatment +||-0.0115|-0.3202|0.0352
72369421|NCT00684060|144248798|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.7|STANDARD_ERROR_OF_MEAN|4.4|<|0.05|TWO_SIDED|95.0|-2.8|1.3||Unadjusted|t-test, 2 sided|||Comparison of change in infarct zone wall motion in the active group minus change in global LVEF in the control group. 80 percent power based on BOOST results||1.3|-2.8|<0.05
72369422|NCT00684060|144248799|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.6|STANDARD_ERROR_OF_MEAN|6.9|<|0.05||95.0|-6.0|0.8|||t-test, 2 sided|||Comparison of change in border zone wall motion in the active group minus change in global LVEF in the control group. 80 percent power based on BOOST results||0.8|-6.0|<0.05
72333184|NCT03525600|144190687|SUPERIORITY|Baseline GA lesion area x Time (continuous) + Baseline GA lesion area x Time Spline at Month 6 (continuous) + Baseline GA lesion area x Time Spline at Month 12 (continuous) + Baseline GA lesion area x Time Spline at Month 18 (continuous). A heterogeneous autoregressive covariance matrix was used to model within-subject errors.|Mean Difference|-0.145||||0.0514|TWO_SIDED|95.0|-0.2909|0.0009|||MMRM model|||Estimates for Month 12 to Month 18: Model included Treatment + Baseline GA lesion area (\< 7.5 mm\^2 or \>= 7.5 mm\^2) + Time (continuous) + Time Spline at Month 6 (continuous) + Time Spline at Month 12 (continuous) + Time Spline at Month 18 (continuous) + Presence of CNV in the fellow eye (Yes or No) + Time (continuous) x Treatment + Time Spline at Month 6 (continuous) x Treatment + Time Spline at Month 12 (continuous) x Treatment + Time Spline at Month 18 (continuous) x Treatment +||0.0009|-0.2909|0.0514
72369423|NCT00702715|144248800|NON_INFERIORITY_OR_EQUIVALENCE|The 95% confidence interval for the estimated median treatment difference in recovery time must have fallen entirely within the pre-specified interval between -60 sec to +60 sec in order to claim equivalence|Median Difference (Final Values)|78.0|||||TWO_SIDED|95.0|36.0|143.0|||Hodges-Lehmann and Moses||Estimated median treatment difference (severe renal impairment minus normal renal function) in recovery time (seconds)|||143.0|36.0|
72333185|NCT03525600|144190687|SUPERIORITY|Baseline GA lesion area x Time (continuous) + Baseline GA lesion area x Time Spline at Month 6 (continuous) + Baseline GA lesion area x Time Spline at Month 12 (continuous) + Baseline GA lesion area x Time Spline at Month 18 (continuous). A heterogeneous autoregressive covariance matrix was used to model within-subject errors.|Mean Difference|-0.168||||0.0265|TWO_SIDED|95.0|-0.3164|-0.0196|||MMRM model|||Estimates for Month 12 to Month 18: Model included Treatment + Baseline GA lesion area (\< 7.5 mm\^2 or \>= 7.5 mm\^2) + Time (continuous) + Time Spline at Month 6 (continuous) + Time Spline at Month 12 (continuous) + Time Spline at Month 18 (continuous) + Presence of CNV in the fellow eye (Yes or No) + Time (continuous) x Treatment + Time Spline at Month 6 (continuous) x Treatment + Time Spline at Month 12 (continuous) x Treatment + Time Spline at Month 18 (continuous) x Treatment +||-0.0196|-0.3164|0.0265
72369424|NCT00702715|144248801|NON_INFERIORITY_OR_EQUIVALENCE|For the secondary endpoint no equivalence margin was specified (i.e., no formal null-hypothesis was specified); the median difference and associated 95% CI were to further characterize the efficacy of severe renal impaired subjects and controls.|Median Difference (Final Values)|68.0|||||TWO_SIDED|95.0|36.0|120.0|||Hodges-Lehmann and Moses||Estimated median treatment difference (severe renal impairment minus normal renal function) in recovery time (seconds)|||120.0|36.0|
72333186|NCT03525600|144190687|SUPERIORITY|Baseline GA lesion area x Time (continuous) + Baseline GA lesion area x Time Spline at Month 6 (continuous) + Baseline GA lesion area x Time Spline at Month 12 (continuous) + Baseline GA lesion area x Time Spline at Month 18 (continuous). A heterogeneous autoregressive covariance matrix was used to model within-subject errors.|Mean Difference|-0.3532|||<|0.0001|TWO_SIDED|95.0|-0.5245|-0.1819|||MMRM model|||Estimates for Month 18 to Month 24: Model included Treatment + Baseline GA lesion area (\< 7.5 mm\^2 or \>= 7.5 mm\^2) + Time (continuous) + Time Spline at Month 6 (continuous) + Time Spline at Month 12 (continuous) + Time Spline at Month 18 (continuous) + Presence of CNV in the fellow eye (Yes or No) + Time (continuous) x Treatment + Time Spline at Month 6 (continuous) x Treatment + Time Spline at Month 12 (continuous) x Treatment + Time Spline at Month 18 (continuous) x Treatment +||-0.1819|-0.5245|<0.0001
72369425|NCT00702715|144248802|NON_INFERIORITY_OR_EQUIVALENCE|For the secondary endpoint no equivalence margin was specified (i.e., no formal null-hypothesis was specified); the median difference and associated 95% CI were to further characterize the efficacy of severe renal impaired subjects and controls.|Median Difference (Final Values)|60.0|||||TWO_SIDED|95.0|31.0|103.0|||Hodges-Lehmann and Moses||Estimated median treatment difference (severe renal impairment minus normal renal function) in recovery time (seconds)|||103.0|31.0|
72369426|NCT02641561|144248822|SUPERIORITY|||||||0.04|||||||Fisher Exact|||||||0.04
72333187|NCT03525600|144190687|SUPERIORITY|Baseline GA lesion area x Time (continuous) + Baseline GA lesion area x Time Spline at Month 6 (continuous) + Baseline GA lesion area x Time Spline at Month 12 (continuous) + Baseline GA lesion area x Time Spline at Month 18 (continuous). A heterogeneous autoregressive covariance matrix was used to model within-subject errors.|Mean Difference|-0.2848||||0.0002|TWO_SIDED|95.0|-0.4336|-0.1361|||MMRM model|||Estimates for Month 18 to Month 24: Model included Treatment + Baseline GA lesion area (\< 7.5 mm\^2 or \>= 7.5 mm\^2) + Time (continuous) + Time Spline at Month 6 (continuous) + Time Spline at Month 12 (continuous) + Time Spline at Month 18 (continuous) + Presence of CNV in the fellow eye (Yes or No) + Time (continuous) x Treatment + Time Spline at Month 6 (continuous) x Treatment + Time Spline at Month 12 (continuous) x Treatment + Time Spline at Month 18 (continuous) x Treatment +||-0.1361|-0.4336|0.0002
72333188|NCT03525600|144190687|SUPERIORITY|Baseline GA lesion area x Time (continuous) + Baseline GA lesion area x Time Spline at Month 6 (continuous) + Baseline GA lesion area x Time Spline at Month 12 (continuous) + Baseline GA lesion area x Time Spline at Month 18 (continuous). A heterogeneous autoregressive covariance matrix was used to model within-subject errors.|Mean Difference|-0.7251||||0.0006|TWO_SIDED|95.0|-1.1373|-0.3129|||MMRM model|||Estimates for Baseline to Month 24: Model included Treatment + Baseline GA lesion area (\< 7.5 mm\^2 or \>= 7.5 mm\^2) + Time (continuous) + Time Spline at Month 6 (continuous) + Time Spline at Month 12 (continuous) + Time Spline at Month 18 (continuous) + Presence of CNV in the fellow eye (Yes or No) + Time (continuous) x Treatment + Time Spline at Month 6 (continuous) x Treatment + Time Spline at Month 12 (continuous) x Treatment + Time Spline at Month 18 (continuous) x Treatment +||-0.3129|-1.1373|0.0006
72333189|NCT03525600|144190687|SUPERIORITY|Baseline GA lesion area x Time (continuous) + Baseline GA lesion area x Time Spline at Month 6 (continuous) + Baseline GA lesion area x Time Spline at Month 12 (continuous) + Baseline GA lesion area x Time Spline at Month 18 (continuous). A heterogeneous autoregressive covariance matrix was used to model within-subject errors.|Mean Difference|-0.698||||0.001|TWO_SIDED|95.0|-1.1142|-0.2817|||MMRM model|||Estimates for Baseline to Month 24: Model included Treatment + Baseline GA lesion area (\< 7.5 mm\^2 or \>= 7.5 mm\^2) + Time (continuous) + Time Spline at Month 6 (continuous) + Time Spline at Month 12 (continuous) + Time Spline at Month 18 (continuous) + Presence of CNV in the fellow eye (Yes or No) + Time (continuous) x Treatment + Time Spline at Month 6 (continuous) x Treatment + Time Spline at Month 12 (continuous) x Treatment + Time Spline at Month 18 (continuous) x Treatment +||-0.2817|-1.1142|0.0010
72333190|NCT01191736|144190691|SUPERIORITY_OR_OTHER|||||||0.05|||||||Kruskal-Wallis|Null hypothesis: the medians for all seven arms are equal.||Kruskal-Wallis test for multiple comparisons||||.05
72333191|NCT01191736|144190692|SUPERIORITY_OR_OTHER|||||||0.05|TWO_SIDED|95.0|||||Chi-squared|Null hypothesis: the proportions within the seven arms are equal.||Comparison of proportions of subjects who assessed responsiveness||||.05
72333192|NCT03703817|144190695|SUPERIORITY|Effectiveness: Multivariate analysis was used to control and remove the possible influence of the independent variables (demographic and clinical characteristics).||||||0.3648|||||||Linear mixed model|||||||0.3648
72333193|NCT03703817|144190695|SUPERIORITY|Side effect: Multivariate analysis was used to control and remove the possible influence of the independent variables (demographic and clinical characteristics).||||||0.1395|||||||Conditional logistic regression|||||||0.1395
72333194|NCT03703817|144190695|SUPERIORITY|Convenience: Multivariate analysis was used to control and remove the possible influence of the independent variables (demographic and clinical characteristics).||||||0.0349|||||||Linear mixed model|||||||0.0349
72333195|NCT03703817|144190695|SUPERIORITY|Global satisfaction: Multivariate analysis was used to control and remove the possible influence of the independent variables (demographic and clinical characteristics).||||||0.1546|||||||Linear mixed model|||||||0.1546
72333196|NCT03703817|144190696|SUPERIORITY|Multivariate analysis was used to control and remove the possible influence of the independent variables (demographic and clinical characteristics).||||||0.1602|||||||Conditional logistic regression model|||||||0.1602
72333197|NCT03703817|144190697|SUPERIORITY|Multivariate analysis was used to control and remove the possible influence of the independent variables (demographic and clinical characteristics).||||||0.9921|||||||Linear mixed model|||||||0.9921
72333198|NCT00349921|144190698|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Chi-squared|||Null hypothesis is that there is no difference between the groups in proportion of patients meeting the success criterion of \>30% reduction in visual analog scale pain 120 min after intrathecal injection||||>0.05
72333199|NCT00778258|144190700|SUPERIORITY_OR_OTHER||Odds Ratio, log|0.77||||0.58|TWO_SIDED|95.0|0.31|1.93|||Regression, Logistic|||||1.93|0.31|0.58
72333200|NCT00778258|144190701|SUPERIORITY_OR_OTHER||Odds Ratio, log|1.13||||0.78|TWO_SIDED|95.0|0.48|2.68|||Chi-squared|||Progression comparison at 12 Months||2.68|0.48|0.78
72333201|NCT00778258|144190701|SUPERIORITY_OR_OTHER||Odds Ratio, log|0.81||||0.62|TWO_SIDED|95.0|0.34|1.91|||Chi-squared|||Progression comparison at 24 Months||1.91|0.34|0.62
72333202|NCT00778258|144190702|SUPERIORITY_OR_OTHER|||||||0.14|TWO_SIDED||||||Chi-squared|||Comparison at 12 Months||||0.14
72333203|NCT00778258|144190702|SUPERIORITY_OR_OTHER|||||||0.17|TWO_SIDED||||||Chi-squared|||Comparison at 24 Months||||0.17
72333204|NCT00778258|144190702|SUPERIORITY_OR_OTHER|||||||0.33|TWO_SIDED||||||Chi-squared|||Comparison at 36 Months||||0.33
72333205|NCT00778258|144190703|SUPERIORITY_OR_OTHER|||||||0.41|TWO_SIDED||||||Chi-squared|||||||0.41
72333206|NCT00778258|144190704|SUPERIORITY_OR_OTHER|||||||0.09|TWO_SIDED||||||Kruskal-Wallis|||||||0.09
72333207|NCT00778258|144190704|SUPERIORITY_OR_OTHER|||||||0.01||||||Null hypothesis is that correlation = 0|Spearman's Correlation|||||||0.01
72333208|NCT00778258|144190705|SUPERIORITY_OR_OTHER||||||<|0.01|||||||Kruskal-Wallis|||Analysis on Betalactoglobulin||||<0.01
72333209|NCT00778258|144190705|SUPERIORITY_OR_OTHER||||||<|0.01||||||Null hypothesis is that correlation = 0|Spearman Correlation|||Analysis on Betalactoglobulin IgE||||<0.01
72333210|NCT00778258|144190705|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||Kruskal-Wallis|||Analysis on Casein IgE||||<0.01
72333211|NCT00778258|144190705|SUPERIORITY_OR_OTHER||||||<|0.01||||||Null hypothesis is that correlation = 0|Spearman Correlation|||Analysis on Casein IgE||||<0.01
72333212|NCT00778258|144190705|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||Kruskal-Wallis|||Analysis on Cow's Milk IgE||||<0.01
72333213|NCT00778258|144190705|SUPERIORITY_OR_OTHER||||||<|0.01||||||Null hypothesis is that correlation = 0|Spearman Correlation|||Analysis on Cow's Milk IgE||||<0.01
72333214|NCT00778258|144190706|SUPERIORITY_OR_OTHER|||||||0.01|||||||Kruskal-Wallis|||Analysis on Max Basophil Assessment||||0.01
72333215|NCT00778258|144190706|SUPERIORITY_OR_OTHER|||||||0.22||||||Null hypothesis is that correlation = 0|Spearman Correlation|||Analysis on Max Basophil Assessment||||0.22
72333216|NCT00778258|144190706|SUPERIORITY_OR_OTHER|||||||0.59|||||||Kruskal-Wallis|||Analysis on Tregs||||0.59
72333217|NCT00778258|144190706|SUPERIORITY_OR_OTHER|||||||0.32||||||Null hypothesis is that correlation = 0|Spearman Correlation|||Analysis on Tregs||||0.32
72333218|NCT00778258|144190707|SUPERIORITY_OR_OTHER|||||||0.5|TWO_SIDED||||||Kruskal-Wallis|||||||0.50
72333219|NCT00778258|144190708|SUPERIORITY_OR_OTHER|||||||0.033||||||Correlation = -0.18|Spearman Correlation|||Baseline Comparison||||0.033
72333220|NCT00778258|144190708|SUPERIORITY_OR_OTHER|||||||0.002||||||Correlation = -0.34|Spearman Correlation|||Month 12 Comparison||||0.002
72333221|NCT00778258|144190708|SUPERIORITY_OR_OTHER|||||||0.156||||||Correlation = -0.20|Spearman Correlation|||Month 24 Comparison||||0.156
72333222|NCT00778258|144190708|SUPERIORITY_OR_OTHER|||||||0.077||||||Correlation = -0.27|Spearman Correlation|||Month 36 Comparison||||0.077
72333223|NCT00778258|144190709|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||Chi-squared|||36 Month Comparison||||<0.01
72333224|NCT01926041|144190716|SUPERIORITY||Hazard Ratio (HR)|0.64||||0.008|TWO_SIDED|95.0|0.48|0.84||Statistical significance levels were determined by two-tailed tests (P \< 0.05).|Regression, Cox|||||0.84|0.48|0.008
72333225|NCT01926041|144190717|SUPERIORITY||Cox Proportional Hazard|1.85||||0.023|TWO_SIDED|95.0|1.13|3.04||Statistical significance levels were determined by two-tailed tests (P \< 0.05).|Regression, Cox|||||3.04|1.13|0.023
72333226|NCT01926041|144190723|OTHER||Beta Coefficient|-0.1|STANDARD_ERROR_OF_MEAN|0.16|<|0.05|TWO_SIDED||||||Regression, Linear|||||||<0.05
72333227|NCT03111550|144190728|SUPERIORITY|Compare if study AE rate is significantly higher than ISO SPE rate (0.3% for corneal edema)||||||0.02041|ONE_SIDED||||||Exact test on binomial distribution|||||||0.02041
72333228|NCT03111550|144190729|SUPERIORITY|Compare if study AE rate is significantly higher than ISO SPE rate (0.3% for retinal detachment)||||||0.1969|ONE_SIDED|||||For ZQR00 retinal detachment|Exact test on binomial distribution|||||||0.1969
72333229|NCT03111550|144190729|SUPERIORITY|Compare if study AE rate is significantly higher than ISO SPE rate (0.8% for secondary surgical intervention)||||||0.4655|ONE_SIDED|||||For ZHR00 secondary surgical intervention|Exact test of binomial distribution|||||||0.4655
72333230|NCT03111550|144190729|SUPERIORITY|Compare if study AE rate is significantly higher than ISO SPE rate (0.8% for secondary surgical intervention)||||||0.021|ONE_SIDED|||||For ZQR00 secondary surgical intention|Exact test on binomial distribution|||||||0.0210
72333231|NCT03111550|144190729|SUPERIORITY|Compare if study AE rate is significantly higher than ISO SPE rate (0.8% for secondary surgical intervention)||||||0.4698|ONE_SIDED|||||For ZXR00 secondary surgical intervention|Exact test on binomial distribution|||||||0.4698
72333232|NCT03319953|144190754|SUPERIORITY|||||||0.2079||||||Bayesian method was used to calculate the posterior probability. High posterior probability of a difference between TAK-041 and placebo \>2.0.|Bayesian Normal Linear Model|||||||0.2079
72333233|NCT03319953|144190754|SUPERIORITY|||||||0.0633||||||Bayesian method was used to calculate the posterior probability. High posterior probability of a difference between TAK-041 and placebo \>2.0.|Bayesian Normal Linear Model|||||||0.0633
72333234|NCT03319953|144190755|SUPERIORITY|||||||0.1706||||||Bayesian method was used to calculate the posterior probability. High posterior probability of a difference between TAK-041 and placebo \>0.09.|Bayesian Normal Linear Model|||||||0.1706
72333235|NCT03319953|144190755|SUPERIORITY|||||||0.0373||||||Bayesian method was used to calculate the posterior probability. High posterior probability of a difference between TAK-041 and placebo \>0.09.|Bayesian Normal Linear Model|||||||0.0373
72333236|NCT01331837|144190763|NON_INFERIORITY_OR_EQUIVALENCE|In order to reject the null hypothesis and claim non-inferiority of TCZ compared to ETA, a HR point estimate of ≤ 1.278 and upper limit of 95% CI \<1.8 was required.|Hazard Ratio (HR)|1.05|||||TWO_SIDED|95.0|0.77|1.43||||||"The analysis assessed in the ITT population the hazard ratio of the primary endpoint in TCZ compared to ETA patients. This was done through a comparison of the hazard functions between TCZ and ETA patients.~A stratified Cox proportional hazards regression model was used in evaluating the relative CV event rate of TCZ over ETA, with the following randomization factors used as strata:~* Previous exposure to anti-TNF (Yes/No)~* History of CV events (Yes/No)"||1.43|0.77|
72333237|NCT01331837|144190765|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin was only formally tested for the primary ITT analysis'|Hazard Ratio (HR)|1.11|||||TWO_SIDED|95.0|0.76|1.62||||||"The analysis assessed in the OT population the hazard ratio of the primary endpoint in TCZ compared to ETA patients. This was done through a comparison of the hazard functions between TCZ and ETA patients.~A stratified Cox proportional hazards regression model was used in evaluating the relative CV event rate of TCZ over ETA, with the following randomization factors used as strata:~* Previous exposure to anti-TNF (Yes/No)~* History of CV events (Yes/No)"||1.62|0.76|
72333238|NCT01331837|144190767|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin was only formally tested for the primary ITT analysis and not for the sensitivity analysis.|Hazard Ratio (HR)|1.01|||||TWO_SIDED|95.0|0.73|1.4||||||"The analysis assessed in the ITT population the hazard ratio of the primary endpoint in TCZ compared to ETA patients. This was done through a comparison of the hazard functions between TCZ and ETA patients.~A stratified Cox proportional hazards regression model was used in evaluating the relative CV event rate of TCZ over ETA, with the following randomization factors used as strata:~* Previous exposure to anti-TNF (Yes/No)~* History of CV events (Yes/No)"||1.40|0.73|
72333239|NCT01331837|144190769|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin was only formally tested for the primary ITT analysis and not for the sensitivity analysis.|Hazard Ratio (HR)|1.04|||||TWO_SIDED|95.0|0.7|1.56||||||"The analysis assessed in the ITT population the hazard ratio of the primary endpoint in TCZ compared to ETA patients. This was done through a comparison of the hazard functions between TCZ and ETA patients.~A stratified Cox proportional hazards regression model was used in evaluating the relative CV event rate of TCZ over ETA, with the following randomization factors used as strata:~* Previous exposure to anti-TNF (Yes/No)~* History of CV events (Yes/No)"||1.56|0.70|
72369427|NCT03751657|144248823|OTHER||Treatment difference|-0.18||||0.0818|TWO_SIDED|95.0|-0.38|0.02|||Mixed Models Analysis|||The response and change from baseline in response after 26 weeks are analysed using a linear mixed model for repeated measures (MMRM) with an unstructured covariance matrix and treatment, region, use of DPP-4 inhibitor and visit as fixed factors, and baseline response as covariate. Furthermore, the model includes the interaction between visit and all explanatory variables.||0.02|-0.38|0.0818
72333240|NCT01331837|144190771|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin was only formally tested for the primary ITT analysis.|Hazard Ratio (HR)|0.99|||||TWO_SIDED|95.0|0.73|1.34||||||"The analysis assessed in the ITT population the hazard ratio of the secondary endpoint in TCZ compared to ETA patients. This was done through a comparison of the hazard functions between TCZ and ETA patients.~A stratified Cox proportional hazards regression model was used in evaluating the relative CV event rate of TCZ over ETA, with the following randomization factors used as strata:~* Previous exposure to anti-TNF (Yes/No)~* History of CV events (Yes/No)"||1.34|0.73|
72369428|NCT03751657|144248837|OTHER||Treatment difference|-1.97||||0.0818|TWO_SIDED|95.0|-4.19|0.25|||Mixed Models Analysis|||The response and change from baseline in response after 26 weeks are analysed using a linear MMRM with an unstructured covariance matrix and treatment, region, use of DPP-4 inhibitor and visit as fixed factors, and baseline response as covariate.Furthermore, the model includes the interaction between visit and all explanatory variables.||0.25|-4.19|0.0818
72333241|NCT01331837|144190773|NON_INFERIORITY_OR_EQUIVALENCE|'The non-inferiority margin was only formally tested for the primary ITT analysis'|Hazard Ratio (HR)|0.89|||||TWO_SIDED|95.0|0.54|1.49||||||"The analysis assessed in the ITT population the hazard ratio of the secondary endpoint in TCZ compared to ETA patients. This was done through a comparison of the hazard functions between TCZ and ETA patients.~A stratified Cox proportional hazards regression model was used in evaluating the relative CV event rate of TCZ over ETA, with the following randomization factors used as strata:~* Previous exposure to anti-TNF (Yes/No)~* History of CV events (Yes/No)"||1.49|0.54|
72333242|NCT01331837|144190775|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin was only formally tested for the primary ITT analysis.|Hazard Ratio (HR)|1.03|||||TWO_SIDED|95.0|0.64|1.63||||||"The analysis assessed in the ITT population the hazard ratio of the secondary endpoint in TCZ compared to ETA patients. This was done through a comparison of the hazard functions between TCZ and ETA patients.~A stratified Cox proportional hazards regression model was used in evaluating the relative CV event rate of TCZ over ETA, with the following randomization factors used as strata:~* Previous exposure to anti-TNF (Yes/No)~* History of CV events (Yes/No)"||1.63|0.64|
72333243|NCT01331837|144190777|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin was only formally tested for the primary ITT analysis.|Hazard Ratio (HR)|1.53|||||TWO_SIDED|95.0|0.8|2.92||||||"The analysis assessed in the ITT population the hazard ratio of the secondary endpoint in TCZ compared to ETA patients. This was done through a comparison of the hazard functions between TCZ and ETA patients.~A stratified Cox proportional hazards regression model was used in evaluating the relative CV event rate of TCZ over ETA, with the following randomization factors used as strata:~* Previous exposure to anti-TNF (Yes/No)~* History of CV events (Yes/No)"||2.92|0.80|
72333244|NCT01331837|144190779|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin was only formally tested for the primary ITT analysis.|Hazard Ratio (HR)|0.99|||||TWO_SIDED|95.0|0.7|1.41||||||"The analysis assessed in the ITT population the hazard ratio of the secondary endpoint in TCZ compared to ETA patients. This was done through a comparison of the hazard functions between TCZ and ETA patients.~A stratified Cox proportional hazards regression model was used in evaluating the relative CV event rate of TCZ over ETA, with the following randomization factors used as strata:~* Previous exposure to anti-TNF (Yes/No)~* History of CV events (Yes/No)"||1.41|0.70|
72333245|NCT03040011|144190805|SUPERIORITY|||||||0.39|||||||Kruskal-Wallis|||||||0.39
72333246|NCT03040011|144190806|SUPERIORITY|||||||0.25|||||||Kruskal-Wallis|||||||0.25
72333247|NCT03040011|144190807|SUPERIORITY|||||||0.17|||||||Kruskal-Wallis|||||||0.17
72333248|NCT03040011|144190808|SUPERIORITY|||||||0.45|||||||Kruskal-Wallis|||||||0.45
72333249|NCT03040011|144190809|SUPERIORITY|||||||0.54|||||||Kruskal-Wallis|||||||0.54
72333250|NCT03040011|144190810|SUPERIORITY|||||||0.8|||||||Chi-squared|||||||0.80
72333251|NCT03040011|144190811|SUPERIORITY|||||||0.72|||||||Chi-squared|||||||0.72
72333252|NCT03040011|144190812|SUPERIORITY|||||||0.64|||||||Chi-squared|||||||0.64
72333253|NCT03040011|144190813|SUPERIORITY|||||||0.41|||||||Kruskal-Wallis|||||||0.41
72333254|NCT03040011|144190815|SUPERIORITY|||||||0.96|||||||Chi-squared|||||||0.96
72333255|NCT03040011|144190816|SUPERIORITY|||||||0.9|||||||Chi-squared|||||||0.90
72333256|NCT03040011|144190817|SUPERIORITY|||||||0.49|||||||Chi-squared|||||||0.49
72333257|NCT03040011|144190818|SUPERIORITY|||||||0.19|||||||Chi-squared|||||||0.19
72333258|NCT03040011|144190819|SUPERIORITY|||||||0.35|||||||Kruskal-Wallis|||||||0.35
72333259|NCT03040011|144190820|SUPERIORITY|||||||0.32|||||||Kruskal-Wallis|||||||0.32
72333260|NCT03040011|144190821|SUPERIORITY|||||||0.18|||||||Kruskal-Wallis|||||||0.18
72333261|NCT03040011|144190822|SUPERIORITY|||||||0.68|||||||Kruskal-Wallis|||||||0.68
72333262|NCT03040011|144190823|SUPERIORITY|||||||0.4|||||||Kruskal-Wallis|||||||0.40
72333263|NCT03040011|144190824|SUPERIORITY|||||||0.44|||||||Kruskal-Wallis|||||||0.44
72333264|NCT00306293|144190898|SUPERIORITY_OR_OTHER||Percent change from Placebo|-78.0|||<|0.001||95.0|||||Wilcoxon Rank Sum Test||Percent change in days with Subclinical HSV-2 Viral Shedding after VALTREX 1g treatment from the placebo|||||<0.001
72333265|NCT00306293|144190899|SUPERIORITY_OR_OTHER||Percent change from Baseline|-77.0||||0.014||95.0|||||Wilcoxon Rank Sum||Percent change in 'percentage of days with clinical HSV-2 viral shedding', after VALTREX 1g treatment from the placebo|||||0.014
72333266|NCT05243745|144190919|SUPERIORITY||Adjusted Mean Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.136||0.499|TWO_SIDED|95.0|-0.36|0.18|||ANCOVA|Analysis was performed using ANCOVA model with study product as a factor and baseline Schiff sensitivity score as a covariate.|Adjusted Mean Difference was calculated as Test value minus Comparator 1 value.|Change from Baseline at Day 3||0.18|-0.36|0.4990
72333267|NCT05243745|144190919|SUPERIORITY||Adjusted Mean Difference|-0.56|STANDARD_ERROR_OF_MEAN|0.135|<|0.0001|TWO_SIDED|95.0|-0.83|-0.29|||ANCOVA|Analysis was performed using ANCOVA model with study product as a factor and baseline Schiff sensitivity score as a covariate.|Adjusted Mean Difference was calculated as Test value minus Comparator 2 value.|Change from Baseline at Day 3||-0.29|-0.83|<0.0001
72333268|NCT05243745|144190919|SUPERIORITY||Adjusted Mean Difference|-0.83|STANDARD_ERROR_OF_MEAN|0.137|<|0.0001|TWO_SIDED|95.0|-1.1|-0.56|||ANCOVA|Analysis was performed using ANCOVA model with study product as a factor and baseline Schiff sensitivity score as a covariate.|Adjusted Mean Difference is calculated as Test value minus Negative Control value.|Change from Baseline at Day 3||-0.56|-1.10|<0.0001
72333269|NCT05243745|144190919|SUPERIORITY||Adjusted Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.112||0.009|TWO_SIDED|95.0|-0.52|-0.08|||ANCOVA|Analysis was performed using ANCOVA model with study product as a factor and baseline Schiff sensitivity score as a covariate.|Adjusted Mean Difference was calculated as Test value minus Comparator 1 value.|Change from Baseline at Day 14||-0.08|-0.52|0.0090
72333270|NCT05243745|144190919|SUPERIORITY||Adjusted Mean Difference|-0.67|STANDARD_ERROR_OF_MEAN|0.111|<|0.0001|TWO_SIDED|95.0|-0.89|-0.45|||ANCOVA|Analysis was performed using ANCOVA model with study product as a factor and baseline Schiff sensitivity score as a covariate.|Adjusted Mean Difference was calculated as Test value minus Comparator 2 value.|Change from Baseline at Day 14||-0.45|-0.89|<0.0001
72423772|NCT00909428|144358209|SUPERIORITY||Z-Score|2.803||||0.005|TWO_SIDED||||||Wilcoxon signed rank test|||The null hypothesis is that there is no change from baseline maximal tolerated cystometric capacity following 30 days of treatment with daily 10mg solifenacin succinate.||||.005
72333271|NCT05243745|144190919|SUPERIORITY||Adjusted Mean Difference|-1.44|STANDARD_ERROR_OF_MEAN|0.112|<|0.0001|TWO_SIDED|95.0|-1.66|-1.22|||ANCOVA|Analysis was performed using ANCOVA model with study product as a factor and baseline Schiff sensitivity score as a covariate.|Adjusted Mean Difference was calculated as Test value minus Negative Control value.|Change from Baseline at Day 14||-1.22|-1.66|<0.0001
72333272|NCT05243745|144190919|SUPERIORITY||Adjusted Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.116||0.0007|TWO_SIDED|95.0|-0.63|-0.17|||ANCOVA|Analysis was performed using ANCOVA model with study product as a factor and baseline Schiff sensitivity score as a covariate.|Adjusted Mean Difference was calculated as Test value minus Comparator 1 value.|Change from Baseline at Day 28||-0.17|-0.63|0.0007
72333273|NCT05243745|144190919|SUPERIORITY||Adjusted Mean Difference|-0.62|STANDARD_ERROR_OF_MEAN|0.116|<|0.0001|TWO_SIDED|95.0|-0.85|-0.39|||ANCOVA|Analysis was performed using ANCOVA model with study product as a factor and baseline Schiff sensitivity score as a covariate.|Adjusted Mean Difference was calculated as Test value minus Comparator 2 value.|Change from Baseline at Day 28||-0.39|-0.85|<0.0001
72333274|NCT05243745|144190919|SUPERIORITY||Adjusted Mean Difference|-1.62|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-1.85|-1.38|||ANCOVA|Analysis was performed using ANCOVA model with study product as a factor and baseline Schiff sensitivity score as a covariate.|Adjusted Mean Difference was calculated as Test value minus Negative Control value.|Change from Baseline at Day 28||-1.38|-1.85|<0.0001
72333275|NCT05243745|144190919|SUPERIORITY||Adjusted Mean Difference|-0.36|STANDARD_ERROR_OF_MEAN|0.112||0.0015|TWO_SIDED|95.0|-0.59|-0.14|||ANCOVA|Analysis was performed using ANCOVA model with study product as a factor and baseline Schiff sensitivity score as a covariate.|Adjusted Mean Difference was calculated as Test value minus Comparator 1 value.|Change from Baseline at Day 56||-0.14|-0.59|0.0015
72333276|NCT05243745|144190919|SUPERIORITY||Adjusted Mean Difference|-0.83|STANDARD_ERROR_OF_MEAN|0.113|<|0.0001|TWO_SIDED|95.0|-1.05|-0.61|||ANCOVA|Analysis was performed using ANCOVA model with study product as a factor and baseline Schiff sensitivity score as a covariate.|Adjusted Mean Difference was calculated as Test value minus Comparator 2 value.|Change from Baseline at Day 56||-0.61|-1.05|<0.0001
72333277|NCT05243745|144190919|SUPERIORITY||Adjusted Mean Difference|-1.72|STANDARD_ERROR_OF_MEAN|0.115|<|0.0001|TWO_SIDED|95.0|-1.95|-1.49|||ANCOVA|Analysis was performed using ANCOVA model with study product as a factor and baseline Schiff sensitivity score as a covariate.|Adjusted Mean Difference was calculated as Test value minus Negative Control.|Change from Baseline at Day 56||-1.49|-1.95|<0.0001
72423773|NCT03021668|144358210|EQUIVALENCE|Chi2 test was performed to analyze difference in rates of Surgical Site Infections (SSIs) between the two groups||||||0.003|||||||Chi-squared|||||||0.003
72423774|NCT03021668|144358211|EQUIVALENCE|Students' T-test was used to evaluate any difference in length of stay between the two groups.||||||0.23|||||||t-test, 2 sided|||||||0.23
72333278|NCT05243745|144190920|SUPERIORITY||Adjusted Mean Difference|5.93|STANDARD_ERROR_OF_MEAN|2.572||0.0231|TWO_SIDED|95.0|0.83|11.02|||ANCOVA|Analysis was performed using ANCOVA model with study product, baseline Schiff stratification as a factor and baseline tactile threshold as covariate.|Adjusted Mean Difference was calculated as Test value minus Comparator 1 value.|Change from Baseline at Day 3||11.02|0.83|0.0231
72333279|NCT05243745|144190920|SUPERIORITY||Adjusted Mean Difference|18.42|STANDARD_ERROR_OF_MEAN|2.549|<|0.0001|TWO_SIDED|95.0|13.37|23.47|||ANCOVA|Analysis was performed using ANCOVA model with study product, baseline Schiff stratification as a factor and baseline tactile threshold as covariate.|Adjusted Mean Difference was calculated as Test value minus Comparator 2 value.|Change from Baseline at Day 3||23.47|13.37|<0.0001
72333280|NCT05243745|144190920|SUPERIORITY||Adjusted Mean Difference|23.93|STANDARD_ERROR_OF_MEAN|2.571|<|0.0001|TWO_SIDED|95.0|18.83|29.02|||ANCOVA|Analysis was performed using ANCOVA model with study product, baseline Schiff stratification as a factor and baseline tactile threshold as covariate.|Adjusted Mean Difference was calculated as Test value minus Negative Control.|Change from Baseline at Day 3||29.02|18.83|<0.0001
72333281|NCT05243745|144190920|SUPERIORITY||Adjusted Mean Difference|8.97|STANDARD_ERROR_OF_MEAN|2.293||0.0002|TWO_SIDED|95.0|4.43|13.51|||ANCOVA|Analysis was performed using ANCOVA model with study product, baseline Schiff stratification as a factor and baseline tactile threshold as covariate.|Adjusted Mean Difference was calculated as Test value minus Comparator 1 value.|Change from Baseline at Day 14||13.51|4.43|0.0002
72333282|NCT05243745|144190920|SUPERIORITY||Slope|17.71|STANDARD_ERROR_OF_MEAN|2.265|<|0.0001|TWO_SIDED|95.0|13.22|22.2|||ANCOVA|Analysis was performed using ANCOVA model with study product, baseline Schiff stratification as a factor and baseline tactile threshold as covariate.|Adjusted Mean Difference was calculated as Test value minus Comparator 2 value.|Change from Baseline at Day 14||22.20|13.22|<0.0001
72333283|NCT05243745|144190920|SUPERIORITY||Adjusted Mean Difference|32.81|STANDARD_ERROR_OF_MEAN|2.288|<|0.0001|TWO_SIDED|95.0|28.27|37.34|||ANCOVA|Analysis was performed using ANCOVA model with study product, baseline Schiff stratification as a factor and baseline tactile threshold as covariate.|Adjusted Mean Difference was calculated as Test value minus Negative Control.|Change from Baseline at Day 14||37.34|28.27|<0.0001
72333284|NCT05243745|144190920|SUPERIORITY||Adjusted Mean Difference|10.2|STANDARD_ERROR_OF_MEAN|2.485|<|0.0001|TWO_SIDED|95.0|5.28|15.13|||ANCOVA|Analysis was performed using ANCOVA model with study product, baseline Schiff stratification as a factor and baseline tactile threshold as covariate.|Adjusted Mean Difference was calculated as Test value minus Comparator 1 value.|Change from Baseline at Day 28||15.13|5.28|<0.0001
72333285|NCT05243745|144190920|SUPERIORITY||Adjusted Mean Difference|13.92|STANDARD_ERROR_OF_MEAN|2.46|<|0.0001|TWO_SIDED|95.0|9.05|18.8|||ANCOVA|Analysis was performed using ANCOVA model with study product, baseline Schiff stratification as a factor and baseline tactile threshold as covariate.|Adjusted Mean Difference was calculated as Test value minus Comparator 2 value.|Change from Baseline at Day 28||18.80|9.05|<0.0001
72333286|NCT05243745|144190920|SUPERIORITY||Adjusted Mean Difference|36.51|STANDARD_ERROR_OF_MEAN|2.568|<|0.0001|TWO_SIDED|95.0|31.42|41.6|||ANCOVA|Analysis was performed using ANCOVA model with study product, baseline Schiff stratification as a factor and baseline tactile threshold as covariate.|Adjusted Mean Difference was calculated as Test value minus Negative Control.|Change from Baseline at Day 28||41.60|31.42|<0.0001
72333287|NCT05243745|144190920|SUPERIORITY||Adjusted Mean Difference|9.73|STANDARD_ERROR_OF_MEAN|2.761||0.0006|TWO_SIDED|95.0|4.26|15.2|||ANCOVA|Analysis was performed using ANCOVA model with study product, baseline Schiff stratification as a factor and baseline tactile threshold as covariate.|Adjusted Mean Difference was calculated as Test value minus Comparator 1 value.|Change from Baseline at Day 56||15.20|4.26|0.0006
72333288|NCT05243745|144190920|SUPERIORITY||Adjusted Mean Difference|19.06|STANDARD_ERROR_OF_MEAN|2.772|<|0.0001|TWO_SIDED|95.0|13.57|24.55|||ANCOVA|Analysis was performed using ANCOVA model with study product, baseline Schiff stratification as a factor and baseline tactile threshold as covariate.|Adjusted Mean Difference was calculated as Test value minus Comparator 2 value.|Change from Baseline at Day 56||24.55|13.57|<0.0001
72333289|NCT05243745|144190920|SUPERIORITY||Adjusted Mean Difference|39.33|STANDARD_ERROR_OF_MEAN|2.829|<|0.0001|TWO_SIDED|95.0|33.73|44.94|||ANCOVA|Analysis was performed using ANCOVA model with study product, baseline Schiff stratification as a factor and baseline tactile threshold as covariate.|Adjusted Mean Difference was calculated as Test value minus Negative Control value.|Change from Baseline at Day 56||44.94|33.73|<0.0001
72333290|NCT01120236|144190961|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.24||||0.16|TWO_SIDED||||||Fisher Exact||Arm I (Androgen Deprivation and Cixutumumab) represents the numerator and Arm II (Androgen Deprivation Therapy) represents the denominator for relative risk.|An intention-to-treat approach was used in analysis of the primary endpoint. A 45% undetectable PSA \<= 0.2 ng/mL rate at 28 weeks was assumed for (control) arm II , based on data from SWOG 9346. Using a one-sided type I error rate of 0.10, we had 90% statistical power to detect an absolute difference of 20% in the undetectable PSA rate with the addition of cixutumumab using Fisher's exact test.||||0.16
72333291|NCT01120236|144190963|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.82||||0.11|TWO_SIDED||||||Fisher Exact||Arm I (Androgen Deprivation and Cixutumumab) represents the numerator and Arm II (Androgen Deprivation Therapy) represents the denominator for relative risk.|Proportion of patients in each arm with PSA \> 4 ng/mL after seven cycles of protocol treatment were compared.||||0.11
72333292|NCT00117715|144190988|OTHER|||||||0.035||||||Post-hoc analysis performed using Tukey's Honestly Significant Difference test.|ANOVA|||Univariate analysis (ANOVA) of the change in log(DM/DX) over time||||0.035
72423775|NCT03445065|144358225|SUPERIORITY||Mean Difference (Net)|-0.1||||0.341|TWO_SIDED|95.0|-0.4|0.1||The significance level was set to p\<0.05 (two-sided).|ANCOVA|The ANCOVA model included arm, centre, and type of diabetes as fixed classification effects, and HbA1c (%) at inclusion as baseline covariate.|The mean difference in HbA1c (%) at Day 180 was calculated as the Enabled group minus the Control group.|||0.1|-0.4|0.341
72333293|NCT00117715|144190989|OTHER|||||||0.194||||||Post-hoc analysis performed using Tukey's Honestly Significant Difference test.|ANOVA|||Univariate analysis (ANOVA) of the change in log(3HM/DX) over time||||0.194
72333294|NCT00117715|144190990|OTHER|||||||0.831||||||Post-hoc analysis performed using Tukey's Honestly Significant Difference test.|ANOVA|||Univariate analysis (ANOVA) of the change in log ((AAMU+1MX+1MU)/1,7,U) over time||||0.831
72423776|NCT03445065|144358226|SUPERIORITY||Mean Difference (Net)|-1.6||||0.03892|TWO_SIDED|95.0|-3.1|-0.1||The significance level was set to p\<0.05 (two-sided).|ANCOVA|The ANCOVA model included arm and centre as fixed classification effects and % time in hypoglycemia (\<54mg/dL) Day0-30 as baseline covariate.|The mean difference was calculated as the Enabled group minus the Control group.|||-0.1|-3.1|0.03892
72423777|NCT03445065|144358230|SUPERIORITY||Mean Difference (Net)|5.4||||0.056|TWO_SIDED|95.0|-0.1|10.9||The significance level was set to p\<0.05 (two-sided).|ANCOVA|The model included arm, centre, and diabetes type as fixed classification effects, and % time in euglycemic range (Day0-30) as baseline covariate.|The mean difference was calculated as the Enabled group minus the Control group.|||10.9|-0.1|0.056
72423778|NCT03445065|144358230|SUPERIORITY||Mean Difference (Net)|4.7||||0.01255|TWO_SIDED|95.0|1.0|8.4||The significance level was set to p\<0.05 (two-sided).|ANCOVA|The model included arm and centre as fixed classification effects, and % time in euglycemic range (Day0-30) as baseline covariate.|The mean difference was calculated as the Enabled group minus the Control group.|||8.4|1.0|0.01255
72423779|NCT03445065|144358231|SUPERIORITY||Mean Difference (Net)|-5.5||||0.015|TWO_SIDED|95.0|-9.9|-1.1||The significance level was set to p\<0.05 (two-sided).|ANCOVA|Model included arm, centre, and diabetes type as fixed classification effects, and % time in hyperglycemia \>250mg/dL Day0-30 as baseline covariate.|The mean difference was calculated as the Enabled group minus the Control group.|||-1.1|-9.9|0.015
72423780|NCT03445065|144358231|SUPERIORITY||Mean Difference (Net)|-1.0||||0.50266|TWO_SIDED|95.0|-4.0|2.0||The significance level was set to p\<0.05 (two-sided).|ANCOVA|The model included arm and centre as fixed classification effects, and % time in hyperglycemia (\>250mg/dL) Day0-30 as baseline covariate.|The mean difference was calculated as the Enabled group minus the Control group.|||2.0|-4.0|0.50266
72423781|NCT03445065|144358232|SUPERIORITY||Mean Difference (Net)|-5.1||||0.08|TWO_SIDED|95.0|-10.9|0.6||The significance level was set to p\<0.05 (two-sided).|ANCOVA|Model included arm, centre, and diabetes type as fixed classification effects, and % time in hyperglycemia \>180mg/dL Day0-30 as baseline covariate.|The mean difference was calculated as the Enabled group minus the Control group.|||0.6|-10.9|0.080
72423782|NCT03445065|144358232|SUPERIORITY||Mean Difference (Net)|-3.3||||0.10637|TWO_SIDED|95.0|-7.3|0.7||The significance level was set to p\<0.05 (two-sided).|ANCOVA|The model included arm and centre as fixed classification effects, and % time in hyperglycemia (\>180mg/dL) Day0-30 as baseline covariate.|The mean difference was calculated as the Enabled group minus the Control group.|||0.7|-7.3|0.10637
72423783|NCT03445065|144358233|SUPERIORITY||Mean Difference (Net)|-0.2||||0.671|TWO_SIDED|95.0|-1.2|0.7||The significance level was set to p\<0.05 (two-sided).|ANCOVA|Model included arm, centre, and diabetes type as fixed classification effects, and % time in hypoglycemia (\<70mg/dL) Day0-30 as baseline covariate.|The mean difference was calculated as the Enabled group minus the Control group.|||0.7|-1.2|0.671
72423784|NCT03445065|144358233|SUPERIORITY||Mean Difference (Net)|-1.8||||0.12935|TWO_SIDED|95.0|-4.1|0.5||The significance level was set to p\<0.05 (two-sided).|ANCOVA|The model included arm and centre as fixed classification effects, and % time in hypoglycemia (\<70mg/dL) Day0-30 as baseline covariate.|The mean difference was calculated as the Enabled group minus the Control group.|||0.5|-4.1|0.12935
72333295|NCT02383420|144190998|SUPERIORITY_OR_OTHER|||||||0.415|TWO_SIDED|||||Level of significance (alpha) = 0.05|t-test, 2 sided|||||||0.415
72423785|NCT03445065|144358234|SUPERIORITY||Mean Difference (Net)|-0.1||||0.693|TWO_SIDED|95.0|-0.6|0.4||The significance level was set to p\<0.05 (two-sided).|ANCOVA|Model included arm, centre, and diabetes type as fixed classification effects, and % time in hypoglycemia (\<54mg/dL) Day0-30 as baseline covariate.|The mean difference was calculated as the Enabled group minus the Control group.|||0.4|-0.6|0.693
72423786|NCT03445065|144358235|SUPERIORITY||Mean Difference (Net)|-0.9||||0.753|TWO_SIDED|95.0|-6.7|4.9||The significance level was set to p\<0.05 (two-sided).|ANCOVA|Model included arm, centre, and diabetes type as fixed classification effects, and % time in euglycemic range (Day0-30) as baseline covariate.|The mean difference was calculated as the Enabled group minus the Control group.|||4.9|-6.7|0.753
72423787|NCT03445065|144358235|SUPERIORITY||Mean Difference (Net)|-0.4||||0.84307|TWO_SIDED|95.0|-4.6|3.8||The significance level was set to p\<0.05 (two-sided).|ANCOVA|The model included arm and centre as fixed classification effect, and % time in euglycemic range (Day0-30) as baseline covariate.|The mean difference was calculated as the Enabled group minus the Control group.|||3.8|-4.6|0.84307
72423788|NCT03445065|144358236|SUPERIORITY||Mean Difference (Net)|-0.9||||0.653|TWO_SIDED|95.0|-4.8|3.0||The significance level was set to p\<0.05 (two-sided).|ANCOVA|Model included arm, centre, and diabetes type as fixed classification effects, and % time in hyperglycemia (\>250mg/dL) Day0-30 as baseline covariate.|The mean difference was calculated as the Enabled group minus the Control group.|||3.0|-4.8|0.653
72333296|NCT02383420|144190999|SUPERIORITY_OR_OTHER|||||||0|TWO_SIDED|||||Level of significance (alpha) = 0.05|t-test, 1 sided|||||||0.0000
72333297|NCT01089413|144191000|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.04||||0.8579|TWO_SIDED|95.0|0.7|1.54|||Regression, Cox|||||1.54|0.70|0.8579
72423789|NCT03445065|144358236|SUPERIORITY||Mean Difference (Net)|2.3||||0.07261|TWO_SIDED|95.0|-0.2|4.8||The significance level was set to p\<0.05 (two-sided).|ANCOVA|The model included arm and centre as fixed classification effects, and % time in hyperglycemia (\>250mg/dL) Day0-30 as baseline covariate.|The mean difference was calculated as the Enabled group minus the Control group.|||4.8|-0.2|0.07261
72423790|NCT03445065|144358237|SUPERIORITY||Mean Difference (Net)|1.3||||0.685|TWO_SIDED|95.0|-4.9|7.4||The significance level was set to p\<0.05 (two-sided).|ANCOVA|Model included arm, centre, and diabetes type as fixed classification effects, and % time in hyperglycemia (\>180mg/dL) Day0-30 as baseline covariate.|The mean difference was calculated as the Enabled group minus the Control group.|||7.4|-4.9|0.685
72333298|NCT01089413|144191001|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.6||||0.1555|TWO_SIDED|95.0|0.3|1.21|||Regression, Cox|||||1.21|0.30|0.1555
72333299|NCT02526524|144191024|SUPERIORITY||LS Mean|-0.27|STANDARD_ERROR_OF_MEAN|0.184||0.1449|TWO_SIDED|95.0|-0.63|0.09|||Mixed Models Analysis|Included treatment, visit, and treatment-by-visit interaction as fixed effects, and HbA1c value at Baseline as a covariate.||||0.09|-0.63|0.1449
72333300|NCT02526524|144191024|SUPERIORITY||LS Mean|-0.33|STANDARD_ERROR_OF_MEAN|0.18||0.0643|TWO_SIDED|95.0|-0.69|0.02|||Mixed Models Analysis|Included treatment, visit, and treatment-by-visit interaction as fixed effects, and HbA1c value at Baseline as a covariate.||||0.02|-0.69|0.0643
72333301|NCT02526524|144191024|SUPERIORITY||LS Means|-0.42|STANDARD_ERROR_OF_MEAN|0.184||0.0214|TWO_SIDED|95.0|-0.79|-0.06|||Mixed Models Analysis|Included treatment, visit, and treatment-by-visit interaction as fixed effects, and HbA1c value at Baseline as a covariate.||||-0.06|-0.79|0.0214
72333302|NCT02526524|144191024|SUPERIORITY||LS Mean|-0.55|STANDARD_ERROR_OF_MEAN|0.18||0.0022|TWO_SIDED|95.0|-0.91|-0.2|||Mixed Models Analysis|Included treatment, visit, and treatment-by-visit interaction as fixed effects, and HbA1c value at Baseline as a covariate.||||-0.20|-0.91|0.0022
72333303|NCT02526524|144191024|SUPERIORITY||LS Mean|-1.03|STANDARD_ERROR_OF_MEAN|0.184|<|0.0001|TWO_SIDED|95.0|-1.39|-0.67|||Mixed Models Analysis|Included treatment, visit, and treatment-by-visit interaction as fixed effects, and HbA1c value at Baseline as a covariate.||||-0.67|-1.39|<0.0001
72333304|NCT02039219|144191049|SUPERIORITY|The type of statistical test is superiority.|Mean Difference (Net)|1.5|STANDARD_DEVIATION|2.4||0.1758|TWO_SIDED|95.0|||||t-test, 2 sided||Two-sample t-test compared MELD score between OCA and placebo arms at baseline OCA arms had a mean (SD) of 14.9(2.4), Placebo arms had a mean (SD) of 16.4 (2.2).|Baseline||||0.1758
72333305|NCT02039219|144191049|SUPERIORITY|The type of statistical test is superiority.|Mean Difference (Net)|2.4|STANDARD_DEVIATION|6.8||0.3839|TWO_SIDED|95.0|||||t-test, 2 sided||Two-sample t-test compared MELD score between OCA and placebo arms at day 42 OCA arms had a mean (SD) of 11.5 (6.8), Placebo arms had a mean (SD) of 13.9(4.6).|Day 42||||0.3839
72333306|NCT02039219|144191057|SUPERIORITY|The type of statistical test is superiority.|Survival Anaylsis|0.0||||0.3938|ONE_SIDED||||||Log Rank|||Day 42||||.3938
72333307|NCT02039219|144191057|SUPERIORITY|The type of statistical test is superiority.|Survival Anaylsis|0.0||||0.3938|TWO_SIDED||||||Log Rank|||Day 90||||.3938
72423791|NCT03445065|144358237|SUPERIORITY||Mean Difference (Net)|3.1||||0.19785|TWO_SIDED|95.0|-1.6|7.8||The significance level was set to p\<0.05 (two-sided).|ANCOVA|The model included arm and centre as fixed classification effects, and % time in hyperglycemia (\>180mg/dL) Day0-30 as baseline covariate.|The mean difference was calculated as the Enabled group minus the Control group.|||7.8|-1.6|0.19785
72333308|NCT02039219|144191057|SUPERIORITY|The type of statistical test is superiority.|Survival Anaylsis|0.0||||0.3938|TWO_SIDED||||||Log Rank|||Day 180||||.3938
72333309|NCT02039219|144191057|SUPERIORITY|The type of statistical test is superiority.|Survival Analysis|0.09||||0.3938|TWO_SIDED||||||Log Rank|||Day 42||||.3938
72423792|NCT03445065|144358238|SUPERIORITY||Mean Difference (Net)|-0.4||||0.549|TWO_SIDED|95.0|-1.5|0.8||The significance level was set to p\<0.05 (two-sided).|ANCOVA|Model included arm, centre, and diabetes type as fixed classification effects, and % time in hypoglycemia (\<70mg/dL) Day0-30 as baseline covariate.|The mean difference was calculated as the Enabled group minus the Control group.|||0.8|-1.5|0.549
72333310|NCT02039219|144191057|SUPERIORITY|The type of statistical test is superiority.|Survival Analysis|0.09||||0.3938|TWO_SIDED||||||Log Rank|||Day 90||||.3938
72333311|NCT02039219|144191057|SUPERIORITY|The type of statistical test is superiority.|Survival Analysis|0.09||||0.3938|TWO_SIDED||||||Log Rank|||Day 180||||.3938
72333312|NCT02039219|144191061|SUPERIORITY|The type of statistical test is superiority.|Mean Difference (Final Values)|0.4|STANDARD_DEVIATION|2.5||0.8094|TWO_SIDED|95.0|||||t-test, 2 sided|||||||0.8094
72333313|NCT02974855|144191081|SUPERIORITY|Prophylactic treatment with PF-06741086 will be considered superior to On Demand treatment with respect to ABR reduction if 1) the upper limit of the 2-sided 80%CI of the ratio of ABR in PF/historical On Demand is \<1 and 2) the estimate of the ratio of ABR in PF/historical On Demand ≤0.3. Drug will be considered not superior to On Demand treatment if the lower limit of the 2-sided 80%CI of the ratio of PF/historical On Demand \>0.3.|ratio|0.15||||0.0002|TWO_SIDED|80.0|0.08|0.29|||Negative Binomial Model|||The comparator was the Historical on Demand Group||0.29|0.08|0.0002
72369429|NCT03894813|144248839|NON_INFERIORITY|The relevant parameters were determined as follows: test level α=0.05, test power 1-β=0.80, Pt=0.90, Pc=0.75, Nt:Nc=1:1, boundary value Δ= -0.0.068 (excellent), and Fisher's exact test. As a result, the sample size of each group was calculated as 50 patients, 100 patients in total. Considering a loss to follow-up rate of 20%, a sample size of 120 patients was finally determined, with 60 patients in each group.|||||<|0.01|||||||Chi-squared|||||||<0.01
72369430|NCT03894813|144248840|NON_INFERIORITY|The relevant parameters were determined as follows: test level α=0.05, test power 1-β=0.80, Pt=0.90, Pc=0.75, Nt:Nc=1:1, boundary value Δ= -0.0.068 (excellent), and Fisher's exact test. As a result, the sample size of each group was calculated as 50 patients, 100 patients in total. Considering a loss to follow-up rate of 20%, a sample size of 120 patients was finally determined, with 60 patients in each group.|||||<|0.01|||||||Chi-squared|||||||<0.01
72333314|NCT02974855|144191081|SUPERIORITY|Prophylactic treatment with PF-06741086 will be considered superior to On Demand treatment with respect to ABR reduction if 1) the upper limit of the 2-sided 80%CI of the ratio of ABR in PF/historical On Demand is \<1 and 2) the estimate of the ratio of ABR in PF/historical On Demand ≤0.3. Drug will be considered not superior to On Demand treatment if the lower limit of the 2-sided 80%CI of the ratio of PF/historical On Demand \>0.3.|ratio|0.05||||0.0001|TWO_SIDED|80.0|0.02|0.14|||Negative Binomial Model|||The comparator was the Historical on Demand Group||0.14|0.02|0.0001
72423793|NCT03445065|144358238|SUPERIORITY||Mean Difference (Net)|-3.3||||0.0318|TWO_SIDED|95.0|-6.3|-0.3||The significance level was set to p\<0.05 (two-sided).|ANCOVA|The model included arm and centre as fixed classification effects, and % time in hypoglycemia (\<70mg/dL) Day0-30 as baseline covariate.|The mean difference was calculated as the Enabled group minus the Control group.|||-0.3|-6.3|0.03180
72423794|NCT03445065|144358239|SUPERIORITY||Mean Difference (Net)|0.1||||0.859|TWO_SIDED|95.0|-0.6|0.7||The significance level was set to p\<0.05 (two-sided).|ANCOVA|Model included arm, centre, and diabetes type as fixed classification effects, and % time in hypoglycemia (\<54mg/dL) Day0-30 as baseline covariate.|The mean difference was calculated as the Enabled group minus the Control group.|||0.7|-0.6|0.859
72423795|NCT03445065|144358239|SUPERIORITY||Mean Difference (Net)|-2.6||||0.01124|TWO_SIDED|95.0|-4.5|-0.6||The significance level was set to p\<0.05 (two-sided).|ANCOVA|The model included arm and centre as fixed classification effects, and % time in hypoglycemia (\<54mg/dL) Day0-30 as baseline covariate.|The mean difference was calculated as the Enabled group minus the Control group.|||-0.6|-4.5|0.01124
72423796|NCT03445065|144358240|SUPERIORITY||Mean Difference (Net)|-0.802|STANDARD_ERROR_OF_MEAN|0.391||0.045|TWO_SIDED|95.0|-1.1585|-0.018||The significance level was set to p\<0.05 (two-sided).|Mixed Models Analysis|The model included time and centre as fixed classification effects and % time in hypoglycemia (\<54mg/dL) Day0-30 as baseline covariate.|The mean difference was calculated as the Enabled (D150-180) group minus the Enabled (D90-120) group.|||-0.018|-1.1585|0.045
72423797|NCT03445065|144358241|SUPERIORITY||Mean Difference (Net)|0.47|STANDARD_ERROR_OF_MEAN|1.54||0.763|TWO_SIDED|95.0|-2.741|3.682||The significance level was set to p\<0.05 (two-sided).|Mixed Model for Repeated Measures|The model included time and centre as fixed classification effects and % time in hypoglycemia (\<54mg/dL) Day0-30 as baseline covariate.|The mean difference was calculated as the Switch to Enabled (D150-180) group minus the Control (D90-120) group.|||3.682|-2.741|0.763
72423798|NCT03445065|144358242|SUPERIORITY||Mean Difference (Net)|1.3||||0.14|TWO_SIDED|95.0|-0.4|3.0||The significance level was set to p\<0.05 (two-sided).|ANCOVA|Model included arm, centre, and diabetes type as fixed classification effects, and glucose variability Day0-30 as baseline covariate.|The mean difference was calculated as the Enabled group minus the Control group.|||3.0|-0.4|0.140
72423799|NCT03445065|144358242|SUPERIORITY||Mean Difference (Net)|-0.5||||0.6411|TWO_SIDED|95.0|-2.6|1.6||The significance level was set to p\<0.05 (two-sided).|ANCOVA|The model included arm and centre as fixed classification effects, and glucose variability Day0-30 as baseline covariate.|The mean difference was calculated as the Enabled group minus the Control group.|||1.6|-2.6|0.64110
72423800|NCT03445065|144358243|SUPERIORITY||Mean Difference (Net)|1.0||||0.339|TWO_SIDED|95.0|-1.1|3.1||The significance level was set to p\<0.05 (two-sided).|ANCOVA|Model included arm, centre, and diabetes type as fixed classification effects, and glucose variability Day0-30 as baseline covariate.|The mean difference was calculated as the Enabled group minus the Control group.|||3.1|-1.1|0.339
72423801|NCT03445065|144358243|SUPERIORITY||Mean Difference (Net)|-0.7||||0.57677|TWO_SIDED|95.0|-3.0|1.7||The significance level was set to p\<0.05 (two-sided).|ANCOVA|The model included arm and centre as fixed classification effects, and glucose variability Day0-30 as baseline covariate.|The mean difference was calculated as the Enabled group minus the Control group.|||1.7|-3.0|0.57677
72423802|NCT03445065|144358244|SUPERIORITY||Mean Difference (Net)|-0.1||||0.558|TWO_SIDED|95.0|-0.3|0.2||The significance level was set to p\<0.05 (two-sided).|ANCOVA|The model included arm, centre, and diabetes type as fixed classification effects, and HbA1c (%) at inclusion as baseline covariate.|The mean difference was calculated as the Enabled group minus the Control group.|||0.2|-0.3|0.558
72423803|NCT03445065|144358244|SUPERIORITY||Mean Difference (Net)|-0.1||||0.408|TWO_SIDED|95.0|-0.3|0.1||The significance level was set to p\<0.05 (two-sided).|ANCOVA|The model included arm and centre as fixed classification effects, and HbA1c (%) at inclusion as baseline covariate.|The mean difference was calculated as the Enabled group minus the Control group.|||0.1|-0.3|0.408
72423804|NCT03445065|144358245|SUPERIORITY||Mean Difference (Net)|0.1||||0.616|TWO_SIDED|95.0|-0.2|0.4||The significance level was set to p\<0.05 (two-sided).|ANCOVA|The model included arm and centre as fixed classification effects, and HbA1c (%) at inclusion as baseline covariate.|The mean difference in HbA1c (%) at Day 180 was calculated as the Enabled group minus the Control group.|||0.4|-0.2|0.616
72423805|NCT03315130|144358266|SUPERIORITY||LS Mean Difference|-2.3|STANDARD_ERROR_OF_MEAN|1.7|=|0.0941|TWO_SIDED|80.0|-4.5|-0.1||1-sided p-value is presented for each active treatment arm compared to the Placebo treatment arm.|ANCOVA||LS mean difference and associated confidence interval are presented for each active treatment arm compared to the Placebo treatment arm.|||-0.1|-4.5|=0.0941
72423806|NCT03315130|144358266|SUPERIORITY||LS Mean Difference|-2.8|STANDARD_ERROR_OF_MEAN|1.7|=|0.0538|TWO_SIDED|80.0|-5.1|-0.6||1-sided p-value is presented for each active treatment arm compared to the Placebo treatment arm.|ANCOVA||LS mean difference and associated confidence interval are presented for each active treatment arm compared to the Placebo treatment arm.|||-0.6|-5.1|=0.0538
72423807|NCT03315130|144358267|SUPERIORITY||LS Mean Difference|-2.2|STANDARD_ERROR_OF_MEAN|1.3|=|0.047|TWO_SIDED|80.0|-3.9|-0.5||1-sided p-value is presented for each active treatment arm compared to the Placebo treatment arm.|ANCOVA||LS mean difference and associated confidence interval are presented for each active treatment arm compared to the Placebo treatment arm.|||-0.5|-3.9|=0.0470
72423808|NCT03315130|144358267|SUPERIORITY||LS Mean Difference|-2.3|STANDARD_ERROR_OF_MEAN|1.3|=|0.0392|TWO_SIDED|80.0|-4.0|-0.6||1-sided p-value is presented for each active treatment arm compared to the Placebo treatment arm.|ANCOVA||LS mean difference and associated confidence interval are presented for each active treatment arm compared to the Placebo treatment arm.|||-0.6|-4.0|=0.0392
72423809|NCT03315130|144358268|SUPERIORITY||LS Mean Difference|-5.3|STANDARD_ERROR_OF_MEAN|2.4|=|0.017|TWO_SIDED|80.0|-8.4|-2.1||1-sided p-value is presented for each active treatment arm compared to the Placebo treatment arm.|ANCOVA||LS mean difference and associated confidence interval are presented for each active treatment arm compared to the Placebo treatment arm.|||-2.1|-8.4|=0.0170
72423810|NCT03315130|144358268|SUPERIORITY||LS Mean Difference|-3.7|STANDARD_ERROR_OF_MEAN|2.4|=|0.0624|TWO_SIDED|80.0|-6.9|-0.6||1-sided p-value is presented for each active treatment arm compared to the Placebo treatment arm.|ANCOVA||LS mean difference and associated confidence interval are presented for each active treatment arm compared to the Placebo treatment arm.|||-0.6|-6.9|=0.0624
72423811|NCT03315130|144358269|SUPERIORITY||LS Mean Difference|-2.0|STANDARD_ERROR_OF_MEAN|2.2|=|0.1866|TWO_SIDED|80.0|-4.9|0.9||1-sided p-value is presented for each active treatment arm compared to the Placebo treatment arm.|ANCOVA||LS mean difference and associated confidence interval are presented for each active treatment arm compared to the Placebo treatment arm.|||0.9|-4.9|=0.1866
72423812|NCT03315130|144358269|SUPERIORITY||LS Mean Difference|-4.1|STANDARD_ERROR_OF_MEAN|2.2|=|0.0391|TWO_SIDED|80.0|-7.0|-1.1||1-sided p-value is presented for each active treatment arm compared to the Placebo treatment arm.|ANCOVA||LS mean difference and associated confidence interval are presented for each active treatment arm compared to the Placebo treatment arm.|||-1.1|-7.0|=0.0391
72423813|NCT03315130|144358273|SUPERIORITY||LS Mean Difference|-82.597|STANDARD_ERROR_OF_MEAN|3.563|<|0.0001|TWO_SIDED|80.0|-87.249|-77.946||1-sided p-value is presented for each active treatment arm compared to the Placebo treatment arm.|ANCOVA||LS mean difference and associated confidence interval are presented for each active treatment arm compared to the Placebo treatment arm.|||-77.946|-87.249|<0.0001
72423814|NCT03315130|144358273|SUPERIORITY||LS Mean Difference|-95.689|STANDARD_ERROR_OF_MEAN|3.91|<|0.0001|TWO_SIDED|80.0|-100.794|-90.585||1-sided p-value is presented for each active treatment arm compared to the Placebo treatment arm.|ANCOVA||LS mean difference and associated confidence interval are presented for each active treatment arm compared to the Placebo treatment arm.|||-90.585|-100.794|<0.0001
72333315|NCT02974855|144191081|SUPERIORITY|Prophylactic treatment with PF-06741086 will be considered superior to On Demand treatment with respect to ABR reduction if 1) the upper limit of the 2-sided 80%CI of the ratio of ABR in PF/historical On Demand is \<1 and 2) the estimate of the ratio of ABR in PF/historical On Demand ≤0.3. Drug will be considered not superior to On Demand treatment if the lower limit of the 2-sided 80%CI of the ratio of PF/historical On Demand \>0.3.|ratio|0.15||||0.0002|TWO_SIDED|80.0|0.08|0.29|||Negative Binomial Model|||The comparator was the Historical on Demand Group||0.29|0.08|0.0002
72333316|NCT02974855|144191081|SUPERIORITY|Prophylactic treatment with PF-06741086 will be considered superior to On Demand treatment with respect to ABR reduction if 1) the upper limit of the 2-sided 80%CI of the ratio of ABR in PF/historical On Demand is \<1 and 2) the estimate of the ratio of ABR in PF/historical On Demand ≤0.3. Drug will be considered not superior to On Demand treatment if the lower limit of the 2-sided 80%CI of the ratio of PF/historical On Demand \>0.3.|ratio|0.03||||0.0005|TWO_SIDED|80.0|0.01|0.1|||Negative Binomial Model|||The comparator was the Historical on Demand Group||0.10|0.01|0.0005
72333317|NCT02974855|144191081|SUPERIORITY|Prophylactic treatment with PF-06741086 will be considered superior to On Demand treatment with respect to ABR reduction if 1) the upper limit of the 2-sided 80%CI of the ratio of ABR in PF/historical On Demand is \<1 and 2) the estimate of the ratio of ABR in PF/historical On Demand ≤0.3. Drug will be considered not superior to On Demand treatment if the lower limit of the 2-sided 80%CI of the ratio of PF/historical On Demand \>0.3.|ratio|0.09|||<|0.0001|TWO_SIDED|80.0|0.05|0.16|||Negative Binomial Model|||The comparator was the Historical on Demand Group||0.16|0.05|<0.0001
72333318|NCT02974855|144191081|SUPERIORITY||ratio|0.18|||<|0.0001|TWO_SIDED|80.0|0.11|0.31|||Negative Binomial Model|||On-Study versus Pre-Treatment||0.31|0.11|<0.0001
72333319|NCT02974855|144191081|SUPERIORITY||ratio|0.1||||0.0002|TWO_SIDED|80.0|0.04|0.22|||Negative Binomial Model|||On-Study versus Pre-Treatment||0.22|0.04|0.0002
72333320|NCT02974855|144191081|SUPERIORITY||ratio|0.2||||0.0154|TWO_SIDED|80.0|0.09|0.47|||Negative Binomial Model|||On-Study versus Pre-Treatment||0.47|0.09|0.0154
72333321|NCT02974855|144191081|SUPERIORITY||ratio|0.04||||0.0005|TWO_SIDED|80.0|0.01|0.14|||Negative Binomial Model|||On-Study versus Pre-Treatment||0.14|0.01|0.0005
72333322|NCT02974855|144191081|SUPERIORITY||ratio|0.12|||<|0.0001|TWO_SIDED|80.0|0.08|0.2|||Negative Binomial Model|||On-Study versus Pre-Treatment||0.20|0.08|<0.0001
72333323|NCT03576066|144191098|OTHER|||||||0.6855|||||||Repeated measures analysis|||Least squares (LS) mean difference in HBeAg-positive participants: ABI-H0731 + SOC NUC minus placebo + SOC NUC at Week 24||||0.6855
72333324|NCT03576066|144191098|OTHER|||||||0.175|||||||Repeated measures analysis|||LS mean difference in HBeAg-negative participants: ABI-H0731 + SOC NUC minus placebo + SOC NUC at Week 24||||0.1750
72333325|NCT03576066|144191099|OTHER|||||||0.2916|||||||Repeated measures analysis|||Least squares (LS) mean difference in HBeAg-positive participants: ABI-H0731 + SOC NUC minus placebo + SOC NUC at Week 24||||0.2916
72333326|NCT00129701|144191112|SUPERIORITY|||||||0.064|||||||Wilcoxon (Mann-Whitney)|||||||0.064
72333327|NCT03130439|144191175|OTHER||Objective Response Rate|0.0|||||TWO_SIDED|95.0|0.0|0.247||||||||0.247|0.000|
72333328|NCT03130439|144191178|OTHER||Disease Control Rate|0.222|||||TWO_SIDED|95.0|0.086|0.423||||||||0.423|0.086|
72333329|NCT03130439|144191179|OTHER||Clinical Benefit Rate|0.148|||||TWO_SIDED|95.0|0.042|0.337||||||||0.337|0.042|
72333330|NCT00123162|144191185|SUPERIORITY_OR_OTHER||Mean Difference (Net)|5.3|||<|0.001|TWO_SIDED|95.0|2.9|7.6|||ANCOVA|adjusted for baseline pain intensity (Visual Analog Scale (VAS) score).||With 26 subjects per treatment group and an assumed within-group standard deviation of 7 units, the study was designed to have 90% statistical power for a two-sided, 0.05 significance level test to detect a difference of 6.5 units in TOPAR4 between a single dose of 100 mg of sildenafil and placebo. However, we anticipated subject drop-out as high as 15%; therefore, we planned to recruit 31 subjects per treatment group.||7.6|2.9|<0.001
72333331|NCT00123162|144191186|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-42.6|||<|0.001|TWO_SIDED|95.0|-58.3|-26.8|||Mixed Models Analysis||Comparison of the VAS score at hour 4 (Sildenafil Citrate - Placebo)|||-26.8|-58.3|<.001
72333332|NCT04838054|144191187|SUPERIORITY||Mean Difference (Net)|0.27||||0.28|TWO_SIDED|||||p-values \<0.05 means statistically significant|ANCOVA|||||||0.28
72333333|NCT04838054|144191188|SUPERIORITY||Mean Difference (Net)|0.41||||0.011|TWO_SIDED|||||p\<0.05 means statistically significant|ANCOVA|||||||0.011
72333334|NCT04838054|144191189|SUPERIORITY||Mean Difference (Net)|2.99|||<|0.001|TWO_SIDED||||||ANCOVA|||||||<0.001
72333335|NCT00729677|144191190|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANOVA|||||||.05
72333336|NCT02447250|144191226|OTHER|||||||0.14|||||||Chi-squared|||comparison of mean birth weights between responders and non-responders||||0.14
72333337|NCT02447250|144191227|OTHER|||||||0.16|||||||Chi-squared|||||||0.16
72333338|NCT02447250|144191228|OTHER|||||||1|||||||Fisher Exact|||||||1.0
72333339|NCT02447250|144191230|OTHER|||||||1|||||||Chi-squared|||||||1.0
72333340|NCT02447250|144191231|OTHER|||||||0.5|||||||Fisher Exact|||||||0.50
72333341|NCT01885208|144191240|NON_INFERIORITY|Non-inferiority was concluded if the upper limit of the two-sided 95% confidence interval for the estimated treatment difference between semaglutide 1.0 mg and exenatide ER 2.0 mg was below the pre-specified non-inferiority margin (0.3 %).|Treatment difference|-0.62|||<|0.0001|TWO_SIDED|95.0|-0.8|-0.44|||Mixed Models Analysis|||The post-baseline responses were analysed using a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit.||-0.44|-0.8|< 0.0001
72333342|NCT01885208|144191240|SUPERIORITY|Superiority was concluded if the upper limit of the two-sided 95% confidence interval for the estimated treatment difference between semaglutide 1.0 mg and exenatide ER 2.0 mg was below the pre-specified superiority margin (0 %).|Treatment difference|-0.62|||<|0.0001|TWO_SIDED|95.0|-0.8|-0.44|||Mixed Models Analysis|||The post-baseline responses were analysed using a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit.||-0.44|-0.8|< 0.0001
72333343|NCT01709422|144191246|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.2||||0.05||95.0|||||Chi-squared|||||||0.05
72333344|NCT01709422|144191247|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|28.0||||0.05|TWO_SIDED|95.0|||||t-test, 2 sided|||||||0.05
72423815|NCT03315130|144358274|SUPERIORITY||LS Mean Difference|60.123|STANDARD_ERROR_OF_MEAN|9.394|<|0.0001|TWO_SIDED|80.0|47.839|72.408||1-sided p-value is presented for each active treatment arm compared to the Placebo treatment arm.|ANCOVA||LS mean difference and associated confidence interval are presented for each active treatment arm compared to the Placebo treatment arm.|||72.408|47.839|<0.0001
72333345|NCT01126437|144191258|NON_INFERIORITY_OR_EQUIVALENCE|Three tests were conducted in hierarchical order. Non-inferiority of time to death from any cause was tested on the two Respimat doses: Tio R 5 vs. Tio HH18, then if non-inferiority was achieved Tio R 2.5 vs Tio HH18. If successful, a test of superiority of Tio R5 over Tio HH18 for time to first COPD exacerbation was conducted. The non-inferiority delta for time to death was 1.25. Non-inferiority tests were performed at one-sided α=0.025 level. Superiority test was performed at two sided α=0.05.|Hazard Ratio (HR)|0.957|||||TWO_SIDED|95.0|0.837|1.094|||Regression, Cox|||H0: Hazard Ratio for Respimat/HandiHaler \>= 1.25 Ha: Hazard Ratio for Respimat/HandiHaler \< 1.25||1.094|0.837|
72333346|NCT01126437|144191258|NON_INFERIORITY_OR_EQUIVALENCE|Three tests were conducted in hierarchical order. Non-inferiority of time to death from any cause was tested on the two Respimat doses: Tio R 5 vs. Tio HH18, then if non-inferiority was achieved Tio R 2.5 vs Tio HH18. If successful, a test of superiority of Tio R5 over Tio HH18 for time to first COPD exacerbation was conducted. The non-inferiority delta for time to death was 1.25. Non-inferiority tests were performed at one-sided α=0.025 level. Superiority test was performed at two sided α=0.05.|Hazard Ratio (HR)|0.996|||||TWO_SIDED|95.0|0.872|1.136|||Regression, Cox|||H0: Hazard Ratio for Respimat/HandiHaler \>= 1.25 Ha: Hazard Ratio for Respimat/HandiHaler \< 1.25||1.136|0.872|
72333347|NCT01126437|144191259|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.978||||0.4194|TWO_SIDED|95.0|0.928|1.032|||Regression, Cox|||"H0: Hazard Ratio for Respimat/HandiHaler = 1 Ha: Hazard Ratio for Respimat/HandiHaler ≠ 1~at alpha = 0.05"||1.032|0.928|0.4194
72333348|NCT01126437|144191259|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.016||||0.5593|TWO_SIDED|95.0|0.964|1.07|||Regression, Cox|||"H0: Hazard Ratio for Respimat/HandiHaler = 1 Ha: Hazard Ratio for Respimat/HandiHaler ≠ 1~at alpha = 0.05"||1.070|0.964|0.5593
72333349|NCT01126437|144191259|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.038||||0.1639|TWO_SIDED|95.0|0.985|1.094|||Regression, Cox|||"H0: Hazard Ratio for Respimat/HandiHaler = 1 Ha: Hazard Ratio for Respimat/HandiHaler ≠ 1~at alpha = 0.05"||1.094|0.985|0.1639
72333350|NCT01126437|144191260|NON_INFERIORITY_OR_EQUIVALENCE|The first test performed was to test the main effect for treatment in the mixed model repeated measures (MMRM) model, specifically the 95% CI for the contrast between Tio R 5ug and Tio HH 18ug was compared to the non-inferiority delta of 50 mL. If that test was successful, the second test in the hierarchy was to test the main effect for treatment in the MMRM model, specifically the 95% CI for the contrast between Tio R 2.5 ug and Tio HH 18 ug was compared to the non-inferiority delta of 50 mL.|Adjusted mean difference|-0.01|STANDARD_ERROR_OF_MEAN|0.014|||TWO_SIDED|95.0|-0.038|0.018||An autoregression-1 covariance structure modeled the within-subject errors because visits were equally spaced. The Kenward-Roger approximation estimated denominator degrees of freedom.|Mixed Model Repeated Measures||Model included the fixed, categorical effects of treatment, investigative site, visit, and treatment-by-visit interaction, and continuous, fixed covariates of baseline and baseline-by-visit interaction, and a random term of patient.|"FEV1 was analyzed through Week 120 using REML-based repeated measures.~H0: Adjusted mean difference for Respimat/HandiHaler ≥ 50ml Ha: Adjusted mean difference for Respimat/HandiHaler \< 50 ml"||0.018|-.038|
72333351|NCT01126437|144191260|NON_INFERIORITY_OR_EQUIVALENCE|The first test performed was to test the main effect for treatment in the mixed model repeated measures (MMRM) model, specifically the 95% CI for the contrast between Tio R 5ug and Tio HH 18ug was compared to the non-inferiority delta of 50 mL. If that test was successful, the second test in the hierarchy was to test the main effect for treatment in the MMRM model, specifically the 95% CI for the contrast between Tio R 2.5 ug and Tio HH 18 ug was compared to the non-inferiority delta of 50 mL.|Adjusted mean difference|-0.037|STANDARD_ERROR_OF_MEAN|0.014|||TWO_SIDED|95.0|-0.065|-0.009||An autoregression-1 covariance structure modeled the within-subject errors because visits were equally spaced. The Kenward-Roger approximation estimated denominator degrees of freedom.|Mixed Model Repeated Measures||Model included the fixed, categorical effects of treatment, investigative site, visit, and treatment-by-visit interaction, and continuous, fixed covariates of baseline and baseline-by-visit interaction, and a random term of patient.|"FEV1 was analyzed through Week 120 using REML-based repeated measures.~H0: Adjusted mean difference for Respimat/HandiHaler ≥ 50ml Ha: Adjusted mean difference for Respimat/HandiHaler \< 50 ml"||-.009|-.065|
72333352|NCT01126437|144191261|SUPERIORITY_OR_OTHER||Rate ratio of events|1.01|STANDARD_ERROR_OF_MEAN|0.03||0.833|TWO_SIDED|95.0|0.95|1.06|||Negative binomial regression|||||1.06|0.95|0.8330
72333353|NCT01126437|144191261|SUPERIORITY_OR_OTHER||Rate ratio of events|0.99|STANDARD_ERROR_OF_MEAN|0.03||0.8047|TWO_SIDED|95.0|0.94|1.05|||Negative binomial regression|||||1.05|0.94|0.8047
72333354|NCT01126437|144191261|SUPERIORITY_OR_OTHER||Rate ratio of events|1.01|STANDARD_ERROR_OF_MEAN|0.03||0.6468|TWO_SIDED|95.0|0.96|1.07|||Negative binomial regression|||||1.07|0.96|0.6468
72333355|NCT01126437|144191262|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.068||||0.1762|TWO_SIDED|95.0|0.971|1.176|||Regression, Cox|||||1.176|0.971|0.1762
72333356|NCT01126437|144191262|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.024||||0.6384|TWO_SIDED|95.0|0.929|1.128|||Regression, Cox|||||1.128|0.929|0.6384
72333357|NCT01126437|144191262|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.044||||0.3784|TWO_SIDED|95.0|0.949|1.148|||Regression, Cox|||||1.148|0.949|0.3784
72333358|NCT01126437|144191263|SUPERIORITY_OR_OTHER||Rate ratio of events|1.09|STANDARD_ERROR_OF_MEAN|0.06||0.1255|TWO_SIDED|95.0|0.98|1.22||p-value from negative binomial regression.|Negative binomial regression|||||1.22|0.98|0.1255
72423816|NCT03315130|144358274|SUPERIORITY||LS Mean Difference|57.076|STANDARD_ERROR_OF_MEAN|9.269|<|0.0001|TWO_SIDED|80.0|44.955|69.197||1-sided p-value is presented for each active treatment arm compared to the Placebo treatment arm.|ANCOVA||LS mean difference and associated confidence interval are presented for each active treatment arm compared to the Placebo treatment arm.|||69.197|44.955|<0.0001
72423817|NCT00186498|144358281|SUPERIORITY_OR_OTHER_LEGACY|||||||0.006||||||Test of within subjects contrast: CVLT Long Delay Free Recall Time 1 (baseline) vs Time 2 (30 days): Placebo (F 4.093) p= 0.071; Memantine (F 35.042) p=0.006|Regression, Linear|||||||0.006
72423818|NCT03469284|144358282|OTHER|||||||0.0034|||||||ANOVA|||||||0.0034
72423819|NCT03469284|144358283|OTHER|||||||0.0008|||||||ANOVA|||||||0.0008
72423820|NCT03469284|144358285|OTHER|||||||0.9182|||||||Fisher Exact|||||||0.9182
72423821|NCT03469284|144358286|OTHER|||||||0.1046|||||||Fisher Exact|||||||0.1046
72423822|NCT02202434|144358293|NON_INFERIORITY|10.5% non-inferiority margin|Difference in Percentages|3.1||||0.0027|ONE_SIDED|97.5||8.32|||Farrington-Manning|||||8.32||0.0027
72423823|NCT02202434|144358294|NON_INFERIORITY|9.5% Non-Inferiority margin|Difference in Percentages|-10.1|||<|0.0001|ONE_SIDED|97.5||-4.41|||Farrington-Manning|||||-4.41||<0.0001
72423824|NCT02202434|144358294|SUPERIORITY||Difference in Percentages|-10.2||||0.0006|TWO_SIDED|95.0|-16.3|-4.0|||Chi-squared|||"Superiority analysis was only to be run if the non-inferiority analysis was met.~Superiority analysis was run on Intent to Treat Population."||-4.0|-16.3|0.0006
72423825|NCT02202434|144358295|SUPERIORITY||Difference in Percentages|-6.1|||<|0.0001|TWO_SIDED|95.0|-9.6|-2.6|||Chi-squared|||||-2.6|-9.6|<0.0001
72423826|NCT04091360|144358421|OTHER||GeoMean Ratio|1.221|||<|0.0001|TWO_SIDED|95.0|1.163|1.281|||ANCOVA|||||1.281|1.163|<0.0001
72423827|NCT04091360|144358421|OTHER||GeoMean Ratio|1.203|||<|0.0001|TWO_SIDED|95.0|1.146|1.263|||ANCOVA|||||1.263|1.146|<0.0001
72423828|NCT04091360|144358421|OTHER||GeoMean Ratio|1.139|||<|0.0001|TWO_SIDED|95.0|1.085|1.195|||ANCOVA|||||1.195|1.085|<0.0001
72333359|NCT01126437|144191263|SUPERIORITY_OR_OTHER||Rate ratio of events|1.06|STANDARD_ERROR_OF_MEAN|0.06||0.3441|TWO_SIDED|95.0|0.94|1.18||p-value from negative binomial regression.|Negative binomial regression|||||1.18|0.94|0.3441
72423829|NCT04091360|144358422|OTHER||GeoMean Ratio|1.253|||<|0.0001|TWO_SIDED|95.0|1.151|1.363|||ANCOVA|||||1.363|1.151|<0.0001
72423830|NCT04091360|144358422|OTHER||GeoMean Ratio|1.146||||0.0022|TWO_SIDED|95.0|1.054|1.246|||ANCOVA|||||1.246|1.054|0.0022
72333360|NCT01126437|144191263|SUPERIORITY_OR_OTHER||Rate ratio of events|1.03|STANDARD_ERROR_OF_MEAN|0.06||0.5573|TWO_SIDED|95.0|0.92|1.16||p-value from negative binomial regression.|Negative binomial regression|||||1.16|0.92|0.5573
72423831|NCT04091360|144358422|OTHER||GeoMean Ratio|1.102||||0.0295|TWO_SIDED|95.0|1.01|1.202|||ANCOVA|||||1.202|1.010|0.0295
72423832|NCT04091360|144358422|OTHER||GeoMean Ratio|1.129||||0.0098|TWO_SIDED|95.0|1.032|1.235|||ANCOVA|||||1.235|1.032|0.0098
72423833|NCT04091360|144358422|OTHER||GeoMean Ratio|1.028||||0.54|TWO_SIDED|95.0|0.939|1.125|||ANCOVA|||||1.125|0.939|0.54
72423834|NCT04091360|144358423|OTHER||GeoMean Ratio|1.228|||<|0.0001|TWO_SIDED|95.0|1.142|1.319|||ANCOVA|||||1.319|1.142|<0.0001
72423835|NCT04091360|144358423|OTHER||GeoMean Ratio|1.155||||0.0002|TWO_SIDED|95.0|1.075|1.24|||ANCOVA|||||1.240|1.075|0.0002
72423836|NCT04091360|144358423|OTHER||GeoMean Ratio|1.1||||0.0129|TWO_SIDED|95.0|1.022|1.184|||ANCOVA|||||1.184|1.022|0.0129
72423837|NCT04091360|144358423|OTHER||GeoMean Ratio|1.112||||0.0079|TWO_SIDED|95.0|1.03|1.201|||ANCOVA|||||1.201|1.030|0.0079
72423838|NCT04091360|144358423|OTHER||GeoMean Ratio|1.033||||0.39|TWO_SIDED|95.0|0.957|1.116|||ANCOVA|||||1.116|0.957|0.39
72423839|NCT04091360|144358424|OTHER||GeoMean Ratio|1.137|||<|0.0001|TWO_SIDED|95.0|1.073|1.204|||ANCOVA|||||1.204|1.073|<0.0001
72423840|NCT04091360|144358424|OTHER||GeoMean Ratio|1.091||||0.0041|TWO_SIDED|95.0|1.03|1.155|||ANCOVA|||||1.155|1.030|0.0041
72423841|NCT04091360|144358424|OTHER||GeoMean Ratio|1.019||||0.53|TWO_SIDED|95.0|0.96|1.081|||ANCOVA|||||1.081|0.960|0.53
72423842|NCT04091360|144358432|OTHER||GeoMean Ratio|1.21|||<|0.0001|TWO_SIDED|95.0|1.153|1.27|||ANCOVA|||||1.270|1.153|<0.0001
72423843|NCT04091360|144358432|OTHER||GeoMean Ratio|1.193|||<|0.0001|TWO_SIDED|95.0|1.136|1.252|||ANCOVA|||||1.252|1.136|<0.0001
72423844|NCT04091360|144358432|OTHER||GeoMean Ratio|1.124|||<|0.0001|TWO_SIDED|95.0|1.071|1.179|||ANCOVA|||||1.179|1.071|<0.0001
72423845|NCT04091360|144358433|OTHER||GeoMean Ratio|1.139|||<|0.0001|TWO_SIDED|95.0|1.087|1.194|||ANCOVA|||||1.194|1.087|<0.0001
72423846|NCT04091360|144358433|OTHER||GeoMean Ratio|1.142|||<|0.0001|TWO_SIDED|95.0|1.089|1.197|||ANCOVA|||||1.197|1.089|<0.0001
72423847|NCT04091360|144358433|OTHER||GeoMean Ratio|1.08||||0.0018|TWO_SIDED|95.0|1.031|1.132|||ANCOVA|||||1.132|1.031|0.0018
72423848|NCT04091360|144358434|OTHER||GeoMean Ratio|1.08||||0.0066|TWO_SIDED|95.0|1.022|1.14|||ANCOVA|||||1.140|1.022|0.0066
72423849|NCT04091360|144358434|OTHER||GeoMean Ratio|1.074||||0.0115|TWO_SIDED|95.0|1.017|1.134|||ANCOVA|||||1.134|1.017|0.0115
72423850|NCT04091360|144358434|OTHER||GeoMean Ratio|1.037||||0.18|TWO_SIDED|95.0|0.982|1.096|||ANCOVA|||||1.096|0.982|0.18
72423851|NCT04091360|144358435|OTHER||GeoMean Ratio|1.162|||<|0.0001|TWO_SIDED|95.0|1.122|1.203|||ANCOVA|||||1.203|1.122|<0.0001
72423852|NCT04091360|144358435|OTHER||GeoMean Ratio|1.15|||<|0.0001|TWO_SIDED|95.0|1.111|1.19|||ANCOVA|||||1.190|1.111|<0.0001
72423853|NCT04091360|144358435|OTHER||GeoMean Ratio|1.112|||<|0.0001|TWO_SIDED|95.0|1.074|1.152|||ANCOVA|||||1.152|1.074|<0.0001
72423854|NCT04091360|144358436|OTHER||GeoMean Ratio|1.157|||<|0.0001|TWO_SIDED|95.0|1.119|1.196|||ANCOVA|||||1.196|1.119|<0.0001
72423855|NCT04091360|144358436|OTHER||GeoMean Ratio|1.147|||<|0.0001|TWO_SIDED|95.0|1.11|1.186|||ANCOVA|||||1.186|1.110|<0.0001
72423856|NCT04091360|144358436|OTHER||GeoMean Ratio|1.105|||<|0.0001|TWO_SIDED|95.0|1.068|1.142|||ANCOVA|||||1.142|1.068|<0.0001
72423857|NCT04091360|144358437|OTHER||GeoMean Ratio|1.098|||<|0.0001|TWO_SIDED|95.0|1.059|1.137|||ANCOVA|||||1.137|1.059|<0.0001
72423858|NCT04091360|144358437|OTHER||GeoMean Ratio|1.111|||<|0.0001|TWO_SIDED|95.0|1.072|1.15|||ANCOVA|||||1.150|1.072|<0.0001
72423859|NCT04091360|144358437|OTHER||GeoMean Ratio|1.07||||0.0003|TWO_SIDED|5.0|1.033|1.109|||ANCOVA|||||1.109|1.033|0.0003
72423860|NCT04091360|144358438|OTHER||Median Difference (Final Values)|8.5||||0.47|TWO_SIDED||||||Hodges-Lehmann|||||||0.47
72423861|NCT04091360|144358438|OTHER||Mean Difference (Final Values)|18.0||||0.0059|TWO_SIDED||||||Hodges-Lehmann|||||||0.0059
72333361|NCT01126437|144191264|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.011||||0.6823|TWO_SIDED|95.0|0.959|1.066|||Regression, Cox|||||1.066|0.959|0.6823
72333362|NCT01126437|144191264|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.983||||0.5377|TWO_SIDED|95.0|0.932|1.037|||Regression, Cox|||||1.037|0.932|0.5377
72333363|NCT01126437|144191264|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.028||||0.3048|TWO_SIDED|95.0|0.975|1.084|||Regression, Cox|||||1.084|0.975|0.3048
72333364|NCT01126437|144191265|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.105||||0.3043|TWO_SIDED|95.0|0.913|1.336|||Regression, Cox|||Causes of death from MACE were determined by adjudication.||1.336|0.913|0.3043
72333365|NCT01126437|144191265|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.1||||0.3263|TWO_SIDED|95.0|0.909|1.331|||Regression, Cox|||Causes of death from MACE were determined by adjudication.||1.331|0.909|0.3263
72333366|NCT01126437|144191265|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.004||||0.9644|TWO_SIDED|95.0|0.834|1.209|||Regression, Cox|||Causes of death from MACE were determined by adjudication.||1.209|0.834|0.9644
72333367|NCT01126437|144191266|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.171||||0.2439|TWO_SIDED|95.0|0.898|1.526|||Regression, Cox|||Time to death from MACE was analyzed using the full study duration including vital status follow-up.||1.526|0.898|0.2439
72333368|NCT01126437|144191266|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.111||||0.4413|TWO_SIDED|95.0|0.85|1.453|||Regression, Cox|||Time to death from MACE was analyzed using the full study duration including vital status follow-up.||1.453|0.850|0.4413
72333369|NCT01126437|144191266|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.054||||0.691|TWO_SIDED|95.0|0.814|1.363|||Regression, Cox|||Time to death from MACE was analyzed using the full study duration including vital status follow-up.||1.363|0.814|0.6910
72333370|NCT01220973|144191275|OTHER||Slope|0.74|||||TWO_SIDED|||||||||||||
72333371|NCT02851797|144191309|SUPERIORITY|LS Means, CIs, and p-values are obtained from an analysis of covariance (ANCOVA) model on change from baseline in 4SC at Month 18 with baseline values for: 4SC, time to rise from floor, time to run/walk 10 metres, distance walked in 6 minutes and re-derived age at first dose fitted as covariates, with concomitant steroid use and treatment group as independent classification factors.|generalised least square mean ratio|0.86|||=|0.0345|TWO_SIDED|95.0|0.745|0.989||LS Means, CIs, and p-values are obtained from ANCOVA model on change from baseline in 4SC at Month 18 with baseline values for: the above mentioned parameters as covariates, with steroid use and treatment group as independent classificat factors.|ANCOVA||LS Means, CIs, and p-values are obtained from ANCOVA model on change from baseline in 4SC at Month 18 with baseline values for: the above mentioned parameters as covariates, with steroid use and treatment group as independent classificat factors.|Log transformation applied||0.989|0.745|=0.0345
72333372|NCT02851797|144191310|SUPERIORITY|LS Means, CIs, and p-values are obtained from an analysis of covariance (ANCOVA) model on change from baseline in time to rise from the Floor at Month 18 with baseline values for: 4SC, time to rise from floor, time to run/walk 10 m, distance walked in 6 minutes and re-derived age at first dose fitted as covariates, with concomitant steroid use and treatment group as independent classification factors.|difference in least square means|-3.28|||=|0.3044|TWO_SIDED|95.0|-9.573|3.018||See comment above|ANCOVA||See comment above|||3.018|-9.573|=0.3044
72333373|NCT02851797|144191311|SUPERIORITY|LS Means, CIs, and p-values are obtained from an analysis of covariance (ANCOVA) model on change from baseline in distance walked at the end of the 6-minute walking test (6MWT) at Month 18 with baseline values for: 4SC, time to rise from floor, time to run/walk 10 metres, distance walked in 6 minutes and re-derived age at first dose fitted as covariates, with concomitant steroid use and treatment group as independent classification factors.|Difference in least square means|9.96|||=|0.3723|TWO_SIDED|95.0|-12.071|31.983||See comment above|ANCOVA|LS means, CIs, p-values were obtained from analysis of covariance model on change from baseline in distance walked at the end of the 6MWT at Month18.|See comment above|||31.983|-12.071|=0.3723
72333374|NCT02851797|144191312|SUPERIORITY|LS Means, CIs, and p-values are obtained from an analysis of covariance (ANCOVA) model on change from baseline in total NSAA score at Month 18 with baseline values for: total NSAA score, 4SC, time to rise from floor, time to run/walk 10 metres, distance walked in 6 minutes and re-derived age at first dose fitted as covariates, with concomitant steroid use and treatment group as independent classification factors.|Difference in least square means|1.91|||=|0.0209|TWO_SIDED|95.0|0.295|3.533||Same comment as above|ANCOVA||Same comment as above.|||3.533|0.295|=0.0209
72333375|NCT02851797|144191313|SUPERIORITY|Estimated cumulative failures, ratio of cumulative failures, CIs, and p-values are obtained from a negative binomial regression on the subject cumulative number of failures across all post-baseline visits. Total failed items at baseline, baseline values for: 4SC, time to rise from floor, time to run/walk 10 metres, distance walked in 6 minutes and re-derived age at first dose were included as independent covariates, with treatment group and steroid use included as indep classification factors.|Ratio of cumulative failures|0.61|||=|0.0202|TWO_SIDED|95.0|0.408|0.927||same comment as above|negative binomial regression model|Estimated cumulative failures, their ratio were obtained from a negative binomial regression on the cumulative N of failures across all visits.|"A lower ratio indicates a greater reduction in cumulative loss of function across 18 months for givinostat compared with placebo.~See also comment above."|||0.927|0.408|=0.0202
72333376|NCT02851797|144191314|SUPERIORITY|LS Means, CIs, and p-values are obtained from an analysis of covariance (ANCOVA) model on change from baseline in normalised muscle strength at Month 18 with baseline normalised muscle strength and re-derived age at first dose fitted as covariates, with concomitant steroid use and treatment group as independent classification factors.|Difference in least square means|0.19|||=|0.0902|TWO_SIDED|95.0|-0.03|0.401||same comment as above|ANCOVA||same comment as above|Overall knee extension||0.401|-0.030|=0.0902
72333377|NCT02851797|144191314|SUPERIORITY|LS Means, CIs, and p-values are obtained from an analysis of covariance (ANCOVA) model on change from baseline in normalised muscle strength at Month 18 with baseline normalised muscle strength and re-derived age at first dose fitted as covariates, with concomitant steroid use and treatment group as independent classification factors.|Difference in least square means|0.09|||=|0.1818|TWO_SIDED|95.0|-0.041|0.213||same comment as above|ANCOVA||same comment as above|Overall elbow flexion||0.213|-0.041|=0.1818
72423862|NCT00098254|144358487|SUPERIORITY_OR_OTHER|||||||0.0027||95.0|||||Kaplan-Meier|||||||0.0027
72423863|NCT00098254|144358489|SUPERIORITY_OR_OTHER|||||||0.33||95.0|||||Kaplan-Meier|||||||0.33
72423864|NCT00098254|144358490|SUPERIORITY_OR_OTHER|||||||0.042||95.0|||||Kaplan-Meier|||||||0.042
72423865|NCT00098254|144358491|SUPERIORITY_OR_OTHER|||||||0.028||95.0|||||Kaplan-Meier|||||||0.028
72423866|NCT01807650|144358554|SUPERIORITY_OR_OTHER||||||=|0.0232||||||2-sided, significance level = 0.05|t-test, 2 sided|||"All participants received both treatments and treatments were intra-individually compared.~Hypotheses tested: H0: δ = 0 and H1: δ ≠ 0 with δ being the difference in time to wound closure between treatments."||||=0.0232
72423867|NCT01807650|144358558|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.1|STANDARD_DEVIATION|17.8|=|0.0005|TWO_SIDED|95.0|2.7|9.4||Day 7|t-test, 2 sided||Mean difference in degree of epithelialization \[%\] (Oleogel-S10 and non-adhesive wound dressing minus non-adhesive wound dressing only)|||9.4|2.7|=0.0005
72423868|NCT01807650|144358558|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.2|STANDARD_DEVIATION|16.9|=|0.0002|TWO_SIDED|95.0|3.0|9.4||Day 10|t-test, 2 sided||Mean difference in degree of epithelialization \[%\] (Oleogel-S10 and non-adhesive wound dressing minus non-adhesive wound dressing only)|||9.4|3.0|=0.0002
72423869|NCT01807650|144358558|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.6|STANDARD_DEVIATION|19.3|=|0.0028|TWO_SIDED|95.0|2.0|9.3||Day 14|t-test, 2 sided||Mean difference in degree of epithelialization \[%\] (Oleogel-S10 and non-adhesive wound dressing minus non-adhesive wound dressing only)|||9.3|2.0|=0.0028
72423870|NCT01807650|144358558|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.9|STANDARD_DEVIATION|18.0|=|0.0009|TWO_SIDED|95.0|2.5|9.3||Day 18|t-test, 2 sided||Mean difference in degree of epithelialization \[%\] (Oleogel-S10 and non-adhesive wound dressing minus non-adhesive wound dressing only)|||9.3|2.5|=0.0009
72423871|NCT01807650|144358558|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.6|STANDARD_DEVIATION|15.8|=|0.0003|TWO_SIDED|95.0|2.6|8.6||Day 21|t-test, 2 sided||Mean difference in degree of epithelialization \[%\] (Oleogel-S10 and non-adhesive wound dressing minus non-adhesive wound dressing only)|||8.6|2.6|=0.0003
72423872|NCT01807650|144358558|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.6|STANDARD_DEVIATION|15.1|=|0.0145|TWO_SIDED|95.0|0.7|6.4||Day 28|t-test, 2 sided||Mean difference in degree of epithelialization \[%\] (Oleogel-S10 and non-adhesive wound dressing minus non-adhesive wound dressing only)|||6.4|0.7|=0.0145
72423873|NCT00116844|144358592|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Nonparametric tests-Wilcoxon Rank Sum|||||||<0.001
72423874|NCT00116844|144358593|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Nonparametric tests-Wilcoxon Rank Sum|||||||<0.001
72423875|NCT00116844|144358594|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Prescott's method|||||||<0.001
72423876|NCT00116844|144358595|SUPERIORITY_OR_OTHER|||||||0.8||95.0|||||Nonparametric tests-Wilcoxon Rank Sum|||||||0.800
72423877|NCT00116844|144358596|SUPERIORITY_OR_OTHER|||||||0.229||95.0|||||Nonparametric tests-Wilcoxon Rank Sum|||||||0.229
72423878|NCT00116844|144358597|SUPERIORITY_OR_OTHER|||||||0.0331||95.0|||||Prescott's method|||||||0.0331
72423879|NCT01933880|144358598|SUPERIORITY_OR_OTHER|||||||0.0387|||||||Signed Rank Sum Test|||P-value was calculated to compare the data at Baseline and change at Week 12 for the OROS-MPH group||||0.0387
72423880|NCT01933880|144358599|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||P-value was calculated to compare the data at Baseline and change at Week 1 for the OROS-MPH group||||<0.0001
72423881|NCT01933880|144358600|SUPERIORITY_OR_OTHER|||||||0.0001|||||||t-test, 2 sided|||P-value was calculated to compare the data at Baseline and change at Week 2 for the OROS-MPH group||||0.0001
72423882|NCT01933880|144358601|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||P-value was calculated to compare the data at Baseline and change at Week 3 for the OROS-MPH group||||<0.0001
72423883|NCT01933880|144358602|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||P-value was calculated to compare the data at Baseline and change at Week 7 for the OROS-MPH group||||<0.0001
72423884|NCT01933880|144358603|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||P-value was calculated to compare the data at Baseline and change at Week 12 for the OROS-MPH group||||<0.0001
72423885|NCT02395133|144358627|SUPERIORITY||Percent Change Difference|-14.83|||=|0.0001|TWO_SIDED|95.0|-22.34|-7.33|||ANCOVA|Threshold for significance at 0.05 level.||A 2-sided hierarchical testing procedure was used for the co-primary and key secondary efficacy endpoints in a pre-specified order. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level. Analysis was performed using ANCOVA method.||-7.33|-22.34|= 0.0001
72423886|NCT02395133|144358627|SUPERIORITY||Percent Change Difference|-17.83|||<|0.0001|TWO_SIDED|95.0|-25.33|-10.34|||ANCOVA|Threshold for significance at 0.05 level.||A 2-sided hierarchical testing procedure was used for the co-primary and key secondary efficacy endpoints in a pre-specified order. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level. Analysis was performed using ANCOVA method.||-10.34|-25.33|< 0.0001
72423887|NCT02395133|144358627|SUPERIORITY||Percent Change Difference|-21.61|||<|0.0001|TWO_SIDED|95.0|-28.36|-14.87|||ANCOVA|Threshold for significance at 0.05 level.||A 2-sided hierarchical testing procedure was used for the co-primary and key secondary efficacy endpoints in a pre-specified order. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level. Analysis was performed using ANCOVA method.||-14.87|-28.36|<0.0001
72423888|NCT02395133|144358628|SUPERIORITY||Percentage difference|24.5|||=|0.004|TWO_SIDED|95.0|9.7|39.29||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using Cochran-Mantel-Haenszel test stratified by region, baseline disease severity and Dupilumab regimen received in parent studies.||39.29|9.70|= 0.0040
72423889|NCT02395133|144358628|SUPERIORITY||Percentage difference|28.0|||=|0.0004|TWO_SIDED|95.0|13.32|42.58||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using Cochran-Mantel-Haenszel test stratified by region, baseline disease severity and Dupilumab regimen received in parent studies.||42.58|13.32|= 0.0004
72423890|NCT02395133|144358628|SUPERIORITY||Percentage difference|41.2|||<|0.0001|TWO_SIDED|95.0|28.93|53.52||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using Cochran-Mantel-Haenszel test stratified by region, baseline disease severity and Dupilumab regimen received in parent studies.||53.52|28.93|<0.0001
72423891|NCT02395133|144358629|SUPERIORITY||Percentage difference|21.4|||=|0.013|TWO_SIDED|95.0|4.86|38.0||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using Cochran-Mantel-Haenszel test stratified by region, baseline disease severity and Dupilumab regimen received in parent studies.||38.00|4.86|= 0.0130
72423892|NCT02395133|144358629|SUPERIORITY||Percentage difference|33.5|||=|0.0003|TWO_SIDED|95.0|17.38|49.72||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using Cochran-Mantel-Haenszel test stratified by region, baseline disease severity and Dupilumab regimen received in parent studies.||49.72|17.38|= 0.0003
72423893|NCT02395133|144358629|SUPERIORITY||Percentage difference|42.1|||<|0.0001|TWO_SIDED|95.0|28.36|55.76||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using Cochran-Mantel-Haenszel test stratified by region, baseline disease severity and Dupilumab regimen received in parent studies.||55.76|28.36|<0.0001
72423894|NCT02395133|144358630|SUPERIORITY||Percentage difference|18.5|||=|0.0209|TWO_SIDED|95.0|4.14|32.91||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using Cochran-Mantel-Haenszel test stratified by region, baseline disease severity and Dupilumab regimen received in parent studies.||32.91|4.14|= 0.0209
72423895|NCT02395133|144358630|SUPERIORITY||Percentage difference|29.7|||=|0.0007|TWO_SIDED|95.0|14.89|44.42||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using Cochran-Mantel-Haenszel test stratified by region, baseline disease severity and Dupilumab regimen received in parent studies.||44.42|14.89|= 0.0007
72423896|NCT02395133|144358630|SUPERIORITY||Percentage difference|39.7|||<|0.0001|TWO_SIDED|95.0|27.42|51.95||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using Cochran-Mantel-Haenszel test stratified by region, baseline disease severity and Dupilumab regimen received in parent studies.||51.95|27.42|<0.0001
72423897|NCT02395133|144358631|SUPERIORITY||Percentage difference|-14.4||||0.1048|TWO_SIDED|95.0|-29.21|0.32||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using Cochran-Mantel-Haenszel test stratified by region, baseline disease severity and Dupilumab regimen received in parent studies.||0.32|-29.21|0.1048
72423898|NCT02395133|144358631|SUPERIORITY||Percentage difference|-20.6|||=|0.0107|TWO_SIDED|95.0|-35.32|-5.89||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using Cochran-Mantel-Haenszel test stratified by region, baseline disease severity and Dupilumab regimen received in parent studies.||-5.89|-35.32|= 0.0107
72333378|NCT02851797|144191315|SUPERIORITY|LS Means, CIs, and p-values are obtained from an analysis of covariance (ANCOVA) model on change from baseline in VL MFF at Month 18 with baseline VL MFF and re-derived age at first dose fitted as covariates, with concomitant steroid use and treatment group as independent classification factors.|Difference in least square means|-2.92|||=|0.0354|TWO_SIDED|95.0|-5.641|-0.204||Same comment as above|ANCOVA||Same comment as above|||-0.204|-5.641|=0.0354
72333379|NCT04295681|144191325|SUPERIORITY||Mean Difference (Final Values)|1.09||||0.0006|TWO_SIDED|95.0|0.47|1.7|||t-test, 2 sided||"Estimated value is calculated as MMH-MAP minus Placebo difference in mean MoCA scores changes."|Mean changes of MoCA scores (90th day of treatment minus baseline) were compared.||1.70|0.47|0.0006
72333380|NCT04295681|144191326|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.67|TWO_SIDED|95.0|-0.58|0.37|||t-test, 2 sided||"Estimated value is calculated as MMH-MAP minus Placebo difference in mean MoCA scores changes."|Mean changes of NIHSS scores (baseline minus 12th day of treatment) were compared.||0.37|-0.58|0.67
72333381|NCT04295681|144191326|SUPERIORITY||Mean Difference (Final Values)|0.02||||0.94|TWO_SIDED|95.0|-0.47|0.5|||t-test, 2 sided||"Estimated value is calculated as MMH-MAP minus Placebo difference in mean MoCA scores changes."|Mean changes of NIHSS scores (baseline minus 90th day of treatment) were compared.||0.50|-0.47|0.94
72423899|NCT02395133|144358631|SUPERIORITY||Percentage difference|-36.1|||<|0.0001|TWO_SIDED|95.0|-48.4|-23.74||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using Cochran-Mantel-Haenszel test stratified by region, baseline disease severity and Dupilumab regimen received in parent studies.||-23.74|-48.40|<0.0001
72423900|NCT00045435|144358649|OTHER||Percent|47.0|||||ONE_SIDED|95.0||69.0|||||The criterion for stopping was not met.|The study was to be stopped after 20 patients if the upper bound of a 1-sided 95% confidence interval for relapse-free survival was \<35%.||69||
72423901|NCT00045435|144358650|OTHER||percent|6.0|||||ONE_SIDED|80.0|1.0||||||The stopping criterion was not met.|The study was to be stopped if the lower bound of a 1-sided 80% confidence interval for NRM was greater than 15%|||1|
72423902|NCT03621202|144358661|OTHER||||||||||||||||||The EBBMS sensitivity was 100%.|||
72333382|NCT04295681|144191327|SUPERIORITY|||||||0.89|||||||Fisher Exact|||Test for comparison percentage of patients with no significant disabilities after 90 days of treatment .||||0.89
72333383|NCT04295681|144191328|SUPERIORITY|||||||0.067|||||||Wilcoxon (Mann-Whitney)|||Therapeutic effect score comparison on 90th day of treatment.||||0.067
72333384|NCT04295681|144191328|SUPERIORITY|||||||0.81|||||||Wilcoxon (Mann-Whitney)|||Side effects score comparison on 90th day of treatment.||||0.81
72333385|NCT04295681|144191328|SUPERIORITY|||||||0.17|||||||Wilcoxon (Mann-Whitney)|||Efficacy index score comparison on 90th day of treatment.||||0.17
72333386|NCT04295681|144191329|SUPERIORITY|||||||0.656|||||||Fisher Exact|||The percentage of participants having at least one adverse event were compared.||||0.656
72333387|NCT04295681|144191330|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1
72333388|NCT04295681|144191332|SUPERIORITY|||||||0.96|||||||ANOVA|"P-value for interaction between factors Treatment and Visit is demonstrated."||"Analysis of variance (ANOVA) for repeated measures has been used. Factors are Treatment, Visit and interaction Treatment-Visit. Significance of interaction as a factor representing difference in outcome value dynamics has been tested."||||0.96
72333389|NCT04295681|144191333|SUPERIORITY|||||||0.96|||||||ANOVA|"P-value for interaction between factors Treatment and Visit is demonstrated."||"Analysis of variance (ANOVA) for repeated measures has been used. Factors are Treatment, Visit and interaction Treatment-Visit. Significance of interaction as a factor representing difference in outcome value dynamics has been tested."||||0.96
72333390|NCT04295681|144191334|SUPERIORITY|||||||0.438|||||||ANOVA|"P-value for interaction between factors Treatment and Visit is demonstrated."||"Systolic blood pressure. Analysis of varience (ANOVA) for repeated measures has been used. Factors are Treatment, Visit and interaction Treatment-Visit. Significance of interaction as a factor representing difference in outcome value dynamics has been tested."||||0.438
72333391|NCT04295681|144191334|SUPERIORITY|||||||0.56|||||||ANOVA|"P-value for interaction between factors Treatment and Visit is demonstrated."||"Diastolic blood pressure. Analysis of variance (ANOVA) for repeated measures has been used. Factors are Treatment, Visit and interaction Treatment-Visit. Significance of interaction as a factor representing difference in outcome value dynamics has been tested."||||0.56
72333392|NCT04295681|144191335|SUPERIORITY|||||||0.72|||||||Fisher Exact|||Comparison at the baseline.||||0.72
72333393|NCT04295681|144191335|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison on 90th day of treatment.||||1
72333394|NCT04295681|144191336|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1
72423903|NCT03621202|144358662|OTHER||||||||||||||||||The EBBMS specificity was 75%.|||
72333395|NCT00803400|144191337|OTHER||Mean Difference (Final Values)|1.0|||<|0.001|ONE_SIDED||||||t-test, 1 sided|||A p-value less than 0.05 (≤ 0.05) is statistically significant. It indicates strong evidence against the null hypothesis, as there is less than a 5% probability the null is correct (and the results are random)||||<0.001
72333396|NCT02438384|144191411|SUPERIORITY||Mean Difference (Final Values)|1.7|||||TWO_SIDED|95.0|1.2|2.1||||||||2.1|1.2|
72333397|NCT02438384|144191411|SUPERIORITY||Mean Difference (Final Values)|1.1|||||TWO_SIDED|95.0|0.6|1.6||||||||1.6|0.6|
72333398|NCT03315793|144191415|SUPERIORITY||Least squares mean difference|1.39||||0.5587|TWO_SIDED|98.0|-3.3|6.08|||mixed-effects model repeated measures|||||6.08|-3.30|0.5587
72333399|NCT03315793|144191416|SUPERIORITY||Risk Difference (RD)|5.4||||0.5111|TWO_SIDED|95.0|-10.7|21.5|||Cochran-Mantel-Haenszel|Stratified by age||||21.5|-10.7|0.5111
72333400|NCT03315793|144191417|SUPERIORITY||Risk Difference (RD)|0.0||||1|TWO_SIDED|95.0|-13.5|13.5|||Cochran-Mantel-Haenszel|Stratified by age||||13.5|-13.5|1.0000
72333401|NCT03315793|144191418|SUPERIORITY||Risk Difference (RD)|-4.1||||0.4423|TWO_SIDED|95.0|-14.4|6.3|||Cochran-Mantel-Haenszel|Stratified by age||||6.3|-14.4|0.4423
72333402|NCT03315793|144191419|SUPERIORITY||Least squares mean difference|0.14||||0.3836|TWO_SIDED|95.0|-0.18|0.46|||mixed-effects model repeated measures|||||0.46|-0.18|0.3836
72333403|NCT01579565|144191460|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.59|STANDARD_ERROR_OF_MEAN|0.049||0.0001||95.0|0.494|0.686||p-value based on the generalized Cochran-Mantel-Haenszel (CMH) test stratified by the randomization strata.|Cochran-Mantel-Haenszel|CMH-weighted mean difference (OMS302 - Placebo) is adjusted for the randomization strata.||||0.686|0.494|0.0001
72333404|NCT01579565|144191461|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.58|STANDARD_ERROR_OF_MEAN|1.192||0.0002||95.0|-6.917|-2.244||p-value is based on the generalized CMH test stratified by the randomization strata.|Cochran-Mantel-Haenszel|CMH-weighted mean difference (OMS302 - Placebo) is adjusted for the randomization strata.||||-2.244|-6.917|0.0002
72333405|NCT01579565|144191462|SUPERIORITY_OR_OTHER|||||||0.0001||||||Chi-square test.|Chi-squared|||||||0.0001
72333406|NCT01579565|144191463|SUPERIORITY_OR_OTHER|||||||0.0001||||||Chi-square test|Chi-squared|||||||0.0001
72333407|NCT01579565|144191464|SUPERIORITY_OR_OTHER|||||||0.076||||||Chi-square test|Chi-squared|||||||0.0760
72333408|NCT01579565|144191465|SUPERIORITY_OR_OTHER|||||||0.0806||||||Chi-square test|Chi-squared|||||||0.0806
72333409|NCT01579565|144191466|SUPERIORITY_OR_OTHER|||||||0.0002||||||Generalized CMH test stratified by randomization strata.|Cochran-Mantel-Haenszel|||||||0.0002
72423904|NCT02969525|144358702|OTHER||Correlation statistic|4.6|||=|0.031|||||||Cochran-Mantel-Haenszel|||"Statistic and p-value were calculated using a Cochran-Mantel-Haenszel test (test for non-zero correlation statistic) based on modified ridit scores and including geographic region and prior Tumor Necrosis Factor (TNF) inhibitor exposure as stratification factors.~The 160 loading dose arm was not considered in the dose-response because this is a mixed dose and the test is examining linear dose response."||||=0.031
72423905|NCT02969525|144358702|OTHER|The pairwise testing of each bimekizumab dose versus placebo accounted for multiplicity by using a fixed sequence testing procedure with each bimekizumab dose being tested sequentially from the highest dose to the lowest dose. If the sequential testing failed to reach significance at a significance level of alpha=0.05, then the pairwise testing continued and the comparison was seen as non-significant.|Odds Ratio (OR)|4.2|||=|0.032|TWO_SIDED|95.0|1.13|15.23||The p-values were displayed as nominal p-values.|Regression, Logistic|||For differences in relation to placebo: Odds Ratio, confidence interval, and p-value were derived from a logistic regression model including fixed effects for treatment, geographic region and prior Tumor Factor Necrosis (TNF) inhibitor exposure.||15.23|1.13|=0.032
72423906|NCT02969525|144358702|OTHER|The pairwise testing of each bimekizumab dose versus placebo accounted for multiplicity by using a fixed sequence testing procedure with each bimekizumab dose being tested sequentially from the highest dose to the lowest dose. If the sequential testing failed to reach significance at a significance level of alpha=0.05, then the pairwise testing continued and the comparison was seen as non-significant.|Odds Ratio (OR)|8.1|||=|0.001|TWO_SIDED|95.0|2.28|28.74||The p-values were displayed as nominal p-values.|Regression, Logistic|||For differences in relation to placebo: Odds Ratio, confidence interval, and p-value were derived from a logistic regression model including fixed effects for treatment, geographic region and prior Tumor Factor Necrosis (TNF) inhibitor exposure.||28.74|2.28|=0.001
72423907|NCT02969525|144358702|OTHER|The pairwise testing of each bimekizumab dose versus placebo accounted for multiplicity by using a fixed sequence testing procedure with each bimekizumab dose being tested sequentially from the highest dose to the lowest dose. If the sequential testing failed to reach significance at a significance level of alpha=0.05, then the pairwise testing continued and the comparison was seen as non-significant.|Odds Ratio (OR)|9.7|||<|0.001|TWO_SIDED|95.0|2.73|34.26||The p-values were displayed as nominal p-values.|Regression, Logistic|||For differences in relation to placebo: Odds Ratio, confidence interval, and p-value were derived from a logistic regression model including fixed effects for treatment, geographic region and prior Tumor Factor Necrosis (TNF) inhibitor exposure.||34.26|2.73|<0.001
72423908|NCT02969525|144358702|OTHER|The pairwise testing of each bimekizumab dose versus placebo accounted for multiplicity by using a fixed sequence testing procedure with each bimekizumab dose being tested sequentially from the highest dose to the lowest dose. If the sequential testing failed to reach significance at a significance level of alpha=0.05, then the pairwise testing continued and the comparison was seen as non-significant.|Odds Ratio (OR)|3.7|||=|0.051|TWO_SIDED|95.0|1.0|13.68||The p-values were displayed as nominal p-values.|Regression, Logistic|||For differences in relation to placebo: Odds Ratio, confidence interval, and p-value were derived from a logistic regression model including fixed effects for treatment, geographic region and prior Tumor Factor Necrosis (TNF) inhibitor exposure.||13.68|1.00|=0.051
72423909|NCT02969525|144358703|OTHER||Odds Ratio (OR)|4.6|||=|0.002|TWO_SIDED|95.0|1.73|12.39||No sequential testing procedure was used for the secondary efficacy variables. The p-values were displayed as nominal p-values.|Regression, Logistic|||For differences in relation to Placebo: Odds Ratio, confidence interval, and p-value were derived from a logistic regression model including fixed effects for treatment, geographic region and prior Tumor Necrosis Factor (TNF) inhibitor exposure.||12.39|1.73|=0.002
72333410|NCT01579565|144191467|SUPERIORITY_OR_OTHER|||||||0.3923||||||Treatment comparisons are based on Cochran-Mantel-Haenszel test adjusting for the randomization strata.|Cochran-Mantel-Haenszel|||||||0.3923
72333411|NCT01579565|144191468|SUPERIORITY_OR_OTHER|||||||0.006||||||Treatment comparisons are based on Cochran-Mantel-Haenszel test adjusting for the randomization strata.|Cochran-Mantel-Haenszel|||||||0.0060
72333412|NCT01579565|144191469|SUPERIORITY_OR_OTHER|||||||0.3286||||||Treatment comparisons are based on generalized CMH test stratified by randomization strata.|Cochran-Mantel-Haenszel|||||||0.3286
72333413|NCT01579565|144191470|SUPERIORITY_OR_OTHER|||||||0.2361||||||Treatment comparisons based on Wilcoxon rank-sum test stratified by randomization strata.|Wilcoxon rank-sum test|||||||0.2361
72333414|NCT02791191|144191483|SUPERIORITY|||||||0.418|||||||ANCOVA|||||||0.418
72333415|NCT02791191|144191483|SUPERIORITY|||||||0.231|||||||ANCOVA|||||||0.231
72333416|NCT02791191|144191484|SUPERIORITY|||||||1|||||||Fisher Exact|||White Matter Disease||||1.000
72333417|NCT02791191|144191484|SUPERIORITY|||||||1|||||||Fisher Exact|||White Matter Disease||||1.000
72333418|NCT02791191|144191484|SUPERIORITY|||||||0.404|||||||Fisher Exact|||||||0.404
72333419|NCT02791191|144191484|SUPERIORITY|||||||1|||||||Fisher Exact|||Cortical Superficial Siderous||||1.000
72333420|NCT02791191|144191484|SUPERIORITY|Lacunar Infarct||||||1|||||||Fisher Exact|||||||1.000
72333421|NCT02791191|144191484|SUPERIORITY|||||||0.457|||||||Fisher Exact|||Lacunar Infarct||||0.457
72333422|NCT02791191|144191484|SUPERIORITY|||||||1|||||||Fisher Exact|||Other Infarct||||1.000
72333423|NCT02791191|144191484|SUPERIORITY|||||||0.457|||||||Fisher Exact|||Other Infarct||||0.457
72333424|NCT02791191|144191485|SUPERIORITY|||||||1|||||||Fisher Exact|||Vasogenic Edema||||1.000
72333425|NCT02791191|144191485|SUPERIORITY|||||||0.457|||||||Fisher Exact|||Vasogenic Edema||||0.457
72333426|NCT02791191|144191485|SUPERIORITY|||||||0.703|||||||Fisher Exact|||Increase in Microhemorrhage||||0.703
72333427|NCT02791191|144191485|SUPERIORITY|||||||1|||||||Fisher Exact|||Increase in Microhemorrhage||||1.000
72333428|NCT02791191|144191486|SUPERIORITY|||||||0.452|||||||Fisher Exact|||Treatment Emergent Suicidal Ideation||||0.452
72333429|NCT02791191|144191486|SUPERIORITY|||||||0.279||||||TE Suicidal Ideation|Fisher Exact|||||||0.279
72333430|NCT02791191|144191486|SUPERIORITY|||||||0.293|||||||Fisher Exact|||Emergence of Suicidal Behavior||||0.293
72333431|NCT02791191|144191486|SUPERIORITY|||||||0.486|||||||Fisher Exact|||Emergence of Suicidal Behavior||||0.486
72333432|NCT02791191|144191488|SUPERIORITY||||||<|0.001|||||||ANCOVA|||Amyloid Beta||||<.001
72333433|NCT02791191|144191488|SUPERIORITY|Amyloid Beta|||||<|0.001|||||||ANCOVA|||||||<.001
72333434|NCT02791191|144191488|SUPERIORITY||||||<|0.001|||||||ANCOVA|||Amyloid Beta 1-40||||<.001
72333435|NCT02791191|144191488|SUPERIORITY||||||<|0.001|||||||ANCOVA|||Amyloid Beta 1-40||||<.001
72333436|NCT02791191|144191488|SUPERIORITY||||||<|0.001|||||||ANCOVA|||Amyloid Beta 1-42||||<.001
72333437|NCT02791191|144191488|SUPERIORITY||||||<|0.001|||||||ANCOVA|||Amyloid Beta 1-42||||<.001
72333438|NCT02791191|144191489|SUPERIORITY|||||||0.97|||||||Mixed Model Repeated Measures|||||||0.970
72333439|NCT02791191|144191489|SUPERIORITY|||||||0.586|||||||Mixed Model Repeated Meausres|||||||0.586
72333440|NCT02791191|144191490|SUPERIORITY|||||||0.088|||||||ANCOVA|||||||0.088
72333441|NCT02791191|144191490|SUPERIORITY|||||||0.15|||||||ANCOVA|||||||0.150
72333442|NCT02791191|144191491|SUPERIORITY|||||||0.153|||||||ANCOVA|||||||0.153
72333443|NCT02791191|144191491|SUPERIORITY|||||||0.176|||||||ANCOVA|||||||0.176
72333444|NCT03817463|144191576|OTHER||Adjusted Hazard Ratio|0.7|||<|0.005|TWO_SIDED|95.0|0.6|0.83|||Cox proportional hazard model|Cox proportional hazard model adjusted for unbalanced propensity score (PS)-variables at baseline.||HHF-(broad+specific)||0.83|0.60|<0.005
72333445|NCT03817463|144191576|OTHER||Adjusted Hazard Ratio|0.66|||<|0.005|TWO_SIDED|95.0|0.57|0.78|||Cox proportional hazard model|Cox proportional hazard model adjusted for unbalanced propensity score (PS)-variables at baseline||HHF-(broad + specific).||0.78|0.57|<0.005
72333446|NCT03817463|144191577|OTHER||Ajusted hazard ratio|0.75|||<|0.005|TWO_SIDED|95.0|0.69|0.81|||Cox proportional hazard model|Cox proportional hazard model adjusted for unbalanced propensity score (PS)-variables at baseline.||HHF-broad.||0.81|0.69|<0.005
72333447|NCT03817463|144191577|OTHER||Ajusted hazard ratio|0.78|||<|0.005|TWO_SIDED|95.0|0.69|0.88|||Cox proportional hazard model|Cox proportional hazard model adjusted for unbalanced propensity score (PS)-variables at baseline.||HHF-broad.||0.88|0.69|<0.005
72333448|NCT03817463|144191578|OTHER||Adjusted Hazard Ratio|0.68|||<|0.005|TWO_SIDED|95.0|0.56|0.83|||Cox proportional hazard model|Cox proportional hazard model adjusted for unbalanced propensity score (PS)-variables at baseline.||HHF-specific. Hazards ratios reported include data from all countries with non-missing values.||0.83|0.56|<0.005
72333449|NCT03817463|144191578|OTHER||Adjusted Hazard Ratio|0.64|||<|0.005|TWO_SIDED|95.0|0.51|0.81|||Cox proportional hazard model|Cox proportional hazard model adjusted for unbalanced propensity score (PS)-variables at baseline.||HHF-specific. Hazards ratios reported include data from all countries with non-missing values.||0.81|0.51|<0.005
72333450|NCT03817463|144191579|OTHER||Adjusted Hazard Ratio|0.55|||<|0.005|TWO_SIDED|95.0|0.48|0.63|||Cox proportional hazard model|Cox proportional hazard model adjusted for unbalanced propensity score (PS)-variables at baseline.||||0.63|0.48|<0.005
72333451|NCT03817463|144191579|OTHER||Adjusted Hazard Ratio|0.59|||<|0.005|TWO_SIDED|95.0|0.54|0.65|||Cox proportional hazard model|Cox proportional hazard model adjusted for unbalanced propensity score (PS)-variables at baseline.||||0.65|0.54|<0.005
72333452|NCT03817463|144191580|OTHER||Adjusted Hazard Ratio|0.65|||<|0.05|TWO_SIDED|95.0|0.56|0.76|||Cox proportional hazard model|Cox proportional hazard model adjusted for unbalanced propensity score (PS)-variables at baseline.||||0.76|0.56|<0.05
72333453|NCT03817463|144191580|OTHER||Adjusted Hazard Ratio|0.66|||<|0.005|TWO_SIDED|95.0|0.61|0.72|||Cox proportional hazard model|Cox proportional hazard model adjusted for unbalanced propensity score (PS)-variables at baseline.||||0.72|0.61|<0.005
72333454|NCT03817463|144191581|OTHER||Adjusted Hazard Ratio|0.72|||<|0.005|TWO_SIDED|95.0|0.64|0.82|||Cox proportional hazard model|Cox proportional hazard model adjusted for unbalanced propensity score (PS)-variables at baseline.||||0.82|0.64|<0.005
72333455|NCT03817463|144191581|OTHER||Adjusted Hazard Ratio|0.72|||<|0.005|TWO_SIDED|95.0|0.66|0.78|||Cox proportional hazard model|Cox proportional hazard model adjusted for unbalanced propensity score (PS)-variables at baseline.||||0.78|0.66|<0.005
72333456|NCT03817463|144191582|OTHER||Adjusted Hazard Ratio|1.02||||0.816|TWO_SIDED|95.0|0.88|1.18|||Cox proportional hazard model|Cox proportional hazard model adjusted for unbalanced propensity score (PS)-variables at baseline.||||1.18|0.88|0.816
72333457|NCT03817463|144191582|OTHER||Adjusted Hazard Ratio|0.87||||0.013|TWO_SIDED|95.0|0.78|0.97|||Cox proportional hazard model|Cox proportional hazard model adjusted for unbalanced propensity score (PS)-variables at baseline.||||0.97|0.78|0.013
72333458|NCT03817463|144191583|OTHER||Adjusted Hazard Ratio|0.82|||<|0.011|TWO_SIDED|95.0|0.71|0.96|||Cox proportional hazard model|Cox proportional hazard model adjusted for unbalanced propensity score (PS)-variables at baseline.||Hazards ratios reported include data from all countries with non-missing values.||0.96|0.71|<0.011
72333459|NCT03817463|144191583|OTHER||Adjusted Hazard Ratio|0.84||||0.064|TWO_SIDED|95.0|0.69|1.01|||Cox proportional hazard model|Cox proportional hazard model adjusted for unbalanced propensity score (PS)-variables at baseline.||Hazards ratios reported include data from all countries with non-missing values.||1.01|0.69|0.064
72423910|NCT02969525|144358703|OTHER||Odds Ratio (OR)|11.0|||<|0.001|TWO_SIDED|95.0|3.91|30.95||No sequential testing procedure was used for the secondary efficacy variables. The p-values were displayed as nominal p-values.|Regression, Logistic|||For differences in relation to Placebo: Odds Ratio, confidence interval, and p-value were derived from a logistic regression model including fixed effects for treatment, geographic region and prior Tumor Necrosis Factor (TNF) inhibitor exposure.||30.95|3.91|<0.001
72423911|NCT02969525|144358703|OTHER||Odds Ratio (OR)|6.2|||<|0.001|TWO_SIDED|95.0|2.31|16.84||No sequential testing procedure was used for the secondary efficacy variables. The p-values were displayed as nominal p-values.|Regression, Logistic|||For differences in relation to Placebo: Odds Ratio, confidence interval, and p-value were derived from a logistic regression model including fixed effects for treatment, geographic region and prior Tumor Necrosis Factor (TNF) inhibitor exposure.||16.84|2.31|<0.001
72423912|NCT02969525|144358703|OTHER||Odds Ratio (OR)|4.2|||=|0.004|TWO_SIDED|95.0|1.59|11.35||No sequential testing procedure was used for the secondary efficacy variables. The p-values were displayed as nominal p-values.|Regression, Logistic|||For differences in relation to Placebo: Odds Ratio, confidence interval, and p-value were derived from a logistic regression model including fixed effects for treatment, geographic region and prior Tumor Necrosis Factor (TNF) inhibitor exposure.||11.35|1.59|=0.004
72423913|NCT02969525|144358704|OTHER||Odds Ratio (OR)|2.4|||=|0.279|TWO_SIDED|95.0|0.5|11.31||No sequential testing procedure was used for the secondary efficacy variables. The p-values were displayed as nominal p-values.|Regression, Logistic|||For differences in relation to Placebo: Odds Ratio, confidence interval, and p-value were derived from a logistic regression model including fixed effects for treatment, geographic region and prior Tumor Necrosis Factor (TNF) inhibitor exposure.||11.31|0.50|=0.279
72423914|NCT02969525|144358704|OTHER||Odds Ratio (OR)|4.1|||=|0.065|TWO_SIDED|95.0|0.92|17.88||No sequential testing procedure was used for the secondary efficacy variables. The p-values were displayed as nominal p-values.|Regression, Logistic|||For differences in relation to Placebo: Odds Ratio, confidence interval, and p-value were derived from a logistic regression model including fixed effects for treatment, geographic region and prior Tumor Necrosis Factor (TNF) inhibitor exposure.||17.88|0.92|=0.065
72423915|NCT02969525|144358704|OTHER||Odds Ratio (OR)|7.5|||=|0.006|TWO_SIDED|95.0|1.77|31.28||No sequential testing procedure was used for the secondary efficacy variables. The p-values were displayed as nominal p-values.|Regression, Logistic|||For differences in relation to Placebo: Odds Ratio, confidence interval, and p-value were derived from a logistic regression model including fixed effects for treatment, geographic region and prior Tumor Necrosis Factor (TNF) inhibitor exposure.||31.28|1.77|=0.006
72423916|NCT02969525|144358704|OTHER||Odds Ratio (OR)|2.9|||=|0.172|TWO_SIDED|95.0|0.63|13.39||No sequential testing procedure was used for the secondary efficacy variables. The p-values were displayed as nominal p-values.|Regression, Logistic|||For differences in relation to Placebo: Odds Ratio, confidence interval, and p-value were derived from a logistic regression model including fixed effects for treatment, geographic region and prior Tumor Necrosis Factor (TNF) inhibitor exposure.||13.39|0.63|=0.172
72423917|NCT02172625|144358730|SUPERIORITY_OR_OTHER||week-to-week coefficient of variation %|26.0|||||TWO_SIDED||||||||This was the week-to-week coefficient of variation (CV) obtained at baseline over two different weeks in a fasted state measured at rest.|||||
72423918|NCT02172625|144358731|SUPERIORITY_OR_OTHER||week-to-week coefficient of variation %|15.0|||||TWO_SIDED||||||||This was the week-to-week coefficient of variation (CV) obtained at baseline over two different weeks in a fasted state measured at rest.|||||
72423919|NCT02172625|144358735|SUPERIORITY_OR_OTHER||week-to-week coefficient of variation %|24.0|||||TWO_SIDED||||||||This was the week-to-week coefficient of variation (CV) obtained at baseline over two different weeks in a fasted state measured at rest.|||||
72423920|NCT00524030|144358736|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Wald Test|2-sided 95% adjusted confidence interval constructed using KM product limit estimation and Greenwood's formula for variance with continuity correction||Null hypothesis (H0): Exit rate greater than or equal to (≥)74%||||<0.001
72423921|NCT00524030|144358736|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Wald Test|2-sided 95% adjusted confidence interval constructed using KM product limit estimation and Greenwood's formula for variance with continuity correction||H0: Exite rate ≥68%||||<0.001
72423922|NCT00524030|144358737|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Wald test|2-sided 95% adjusted confidence interval constructed using KM product limit estimation and Greenwood's formula for variance with continuity correction||H0: Exit rate ≥74%||||<0.001
72423923|NCT00524030|144358737|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|TWO_SIDED||||||Wald test|2-sided 95% adjusted confidence interval constructed using KM product limit estimation and Greenwood's formula for variance with continuity correction||H0: Exit rate ≥68%||||0.001
72423924|NCT02707692|144358744|SUPERIORITY||Mean Difference (Final Values)|-988.0||||0.32|TWO_SIDED|95.0|-2996.3|1020.3|||Paired t-test, 2 sided|||Primary hypothesis: Participants will have a higher absolute difference in levels of CD4+ T cell-associated HIV RNA transcription seven days after receiving either Pneumococcal or Influenza vaccinations, when compared to seven days after receiving placebo.||1020.3|-2996.3|0.32
72333460|NCT03817463|144191584|OTHER||Adjusted Hazard Ratio|0.59|||<|0.005|TWO_SIDED|95.0|0.42|0.84|||Cox proportional hazard model|Cox proportional hazard model adjusted for unbalanced propensity score (PS)-variables at baseline.||Hazards ratios reported include data from all countries with non-missing values.||0.84|0.42|<0.005
72423925|NCT02707692|144358744|SUPERIORITY||Mean Difference (Final Values)|-405.0||||0.31|TWO_SIDED|95.0|-1199.7|389.7|||Paired t-test, 2 sided|||Primary hypothesis: Participants will have a higher absolute difference in levels of CD4+ T cell-associated HIV RNA transcription seven days after receiving either Pneumococcal or Influenza vaccinations, when compared to seven days after receiving placebo.||389.7|-1199.7|0.31
72423926|NCT00939731|144358759|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|92.61|||||TWO_SIDED|90.0|84.84|101.09||||||Natural log transformed AUClast of PF-02341066 was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% confidence intervals (CIs) for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||101.09|84.84|
72423927|NCT00939731|144358762|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|92.43|||||TWO_SIDED|90.0|84.86|100.68||||||Natural log transformed AUC (0-∞) of PF-02341066 was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||100.68|84.86|
72423928|NCT00939731|144358763|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|98.91|||||TWO_SIDED|90.0|90.18|108.48||||||Natural log transformed Cmax of PF-02341066 was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CI for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||108.48|90.18|
72423929|NCT01213043|144358767|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence margin was: \[0.80, 1.25\]|Geometric Least Square Means Ratio|0.85|||<|0.0001|TWO_SIDED|90.0|0.83|0.88|||ANOVA|||Dose proportionality was analysed using an ANOVA model for the natural log-transformed AUC0-7days with treatment, period, and sequence as fixed effects and subject within sequence as a random effect. The treatment dose of 60 mg/kg was the reference treatment and 120 mg/kg was the test treatment. PK parameters in individual subjects for each treatment dose were dose normalized to 60mg/kg based on the actual dose administered at Week 8 or Week 18 (i.e., (AUC0-7days/Actual Dose in mg/kg)\*60mg/kg).||0.88|0.83|<0.0001
72423930|NCT01175148|144358787|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.15|||<|0.05|TWO_SIDED||||||Fisher Exact|||The study used a minimax Simon two-stage design to test the null hypothesis Ho: P \> 0.35 versus the alternative H1: \< 0.15, where P is the probability of grade 2 to 4 acute GVHD at day + 100.||||<0.05
72423931|NCT01010477|144358788|SUPERIORITY_OR_OTHER|||||||0.632||||||threshold for statistical significance: p\< 0.05|Fisher Exact|||Fisher Exact test (2-sided)||||0.632
72423932|NCT00462670|144358790|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.09|STANDARD_ERROR_OF_MEAN|0.25|<|0.0001|TWO_SIDED|95.0|-1.58|-0.6|||t-test, 2 sided|||||-0.60|-1.58|<0.0001
72423933|NCT00462670|144358791|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.73|STANDARD_ERROR_OF_MEAN|0.45|<|0.0001|TWO_SIDED|95.0|-2.54|-0.92|||t-test, 2 sided|||||-0.92|-2.54|<0.0001
72423934|NCT02110732|144358792|OTHER|||||||0.05|||||||Fisher Exact|||||||0.05
72423935|NCT02110732|144358793|SUPERIORITY||||||<|0.05|||||||Chi-squared||||Categorical variables were analyzed with Chi-square test or Fisher's exact test. Comparisons between groups were by Levene's test for equality of variances. A P-level \<0.05 was considered statistically significant. Data were analyzed with SPSS v.19 and NCSS.|||< 0.05
72423936|NCT02110732|144358794|SUPERIORITY||||||<|0.05|||||||Chi-squared|||||||< 0.05
72423937|NCT02948959|144358804|SUPERIORITY|To control the type-I error rate for the analysis of outcome measure, a hierarchical testing procedure was applied at a 2-sided 5% significant level. Testing was then performed sequentially in the order endpoints were reported. Hierarchical testing sequence continued only if the previous endpoint was statistically significant.|Risk Ratio (RR)|0.353|||<|0.0001|TWO_SIDED|95.0|0.222|0.562||Threshold for statistical significance at 5% significant level.|Negative binomial model||Risk ratio, also called relative risk compares the risk (rate) of an event among one group with the risk (rate) among another group.|Risk ratio and p-value was derived using negative binomial model with total number of events onset from randomization up to Week 52 visit or last contact date (whichever comes earlier) as response variable, with treatment group, age, baseline weight group, region, baseline eosinophil level, baseline FeNO level, baseline ICS dose level and number of severe exacerbation events within 1 year prior to study as covariates and log-transformed standardized observation duration as an offset variable.||0.562|0.222|<0.0001
72423938|NCT02948959|144358805|SUPERIORITY|Testing was performed according to the hierarchical testing procedure (continued only if the previous endpoint was statistically significant).|Risk Ratio (RR)|0.407|||<|0.0001|TWO_SIDED|95.0|0.274|0.605||Threshold for statistical significance at 5% significant level.|Negative binomial model||Risk ratio, also called relative risk compares the risk (rate) of an event among one group with the risk (rate) among another group.|Risk ratio and p-value was derived using negative binomial model with total number of events onset from randomization up to Week 52 visit or last contact date (whichever comes earlier) as response variable, with treatment group, age, baseline weight group, region, baseline eosinophil level, baseline FeNO level, baseline ICS dose level and number of severe exacerbation events within 1 year prior to study as covariates and log-transformed standardized observation duration as an offset variable.||0.605|0.274|<0.0001
72333461|NCT03817463|144191584|OTHER||Adjusted Hazard Ratio|0.6|||<|0.005|TWO_SIDED|95.0|0.49|0.72|||Cox proportional hazard model|Cox proportional hazard model adjusted for unbalanced propensity score (PS)-variables at baseline.||Hazards ratios reported include data from all countries with non-missing values.||0.72|0.49|<0.005
72423939|NCT02948959|144358806|SUPERIORITY|Testing was performed according to the hierarchical testing procedure (continued only if the previous endpoint was statistically significant).|LS mean difference|5.32||||0.0036|TWO_SIDED|95.0|1.76|8.88||Threshold for statistical significance at 5% significant level.|Mixed-effect model with repeated measure|||P-value and LS mean difference were derived from MMRM model with change from baseline in pre-bronchodilator % predicted FEV1 value up to Week 12 as the response variable, and treatment, baseline weight group, region, ethnicity, baseline eosinophil level, baseline FeNO level, baseline ICS dose level, visit, treatment by-visit interaction, baseline % predicted FEV1 value and baseline-by-visit interaction as covariates.||8.88|1.76|0.0036
72423940|NCT02948959|144358807|SUPERIORITY|Testing was performed according to the hierarchical testing procedure (continued only if the previous endpoint was statistically significant).|LS mean difference|5.21||||0.0009|TWO_SIDED|95.0|2.14|8.27||Threshold for statistical significance at 5% significant level.|Mixed-effect model with repeated measure|||P-value and LS mean difference were derived from MMRM model with change from baseline in pre-bronchodilator % predicted FEV1 value up to Week 12 as the response variable, and treatment, baseline weight group, region, ethnicity, baseline eosinophil level, baseline FeNO level, baseline ICS dose level, visit, treatment by-visit interaction, baseline % predicted FEV1 value and baseline-by visit interaction as covariates.||8.27|2.14|0.0009
72423941|NCT02948959|144358808|SUPERIORITY|Testing was performed according to the hierarchical testing procedure (continued only if the previous endpoint was statistically significant).|LS mean difference|-0.46|||<|0.0001|TWO_SIDED|95.0|-0.66|-0.26||Threshold for statistical significance at 5% significant level.|Mixed-effect model with repeated measure|||P-value and LS mean difference were derived from MMRM model with change from baseline in ACQ-7-IA up to Week 52 as the response variable, and treatment, age, weight group, region, baseline eosinophil level, baseline FeNO level, baseline ICS dose level, visit, treatment by-visit interaction, baseline ACQ-7-IA and baseline-by-visit interaction as covariates.||-0.26|-0.66|<0.0001
72423942|NCT02948959|144358809|SUPERIORITY|Testing was performed according to the hierarchical testing procedure (continued only if the previous endpoint was statistically significant).|LS mean difference|-0.33||||0.0001|TWO_SIDED|95.0|-0.5|-0.16||Threshold for statistical significance at 5% significant level.|Mixed-effect model with repeated measure|||P-value and LS mean difference were derived from MMRM model with change from baseline in ACQ-7-IA up to Week 52 as the response variable, and treatment, age, weight group, region, baseline eosinophil level, baseline FeNO level, baseline ICS dose level, visit, treatment by-visit interaction, baseline ACQ-7-IA and baseline-by-visit interaction as covariates.||-0.16|-0.50|0.0001
72423943|NCT02948959|144358810|SUPERIORITY|Testing was performed according to the hierarchical testing procedure (continued only if the previous endpoint was statistically significant).|LS mean difference|-20.59|||<|0.0001|TWO_SIDED|95.0|-24.6|-16.59||Threshold for statistical significance at 5% significant level.|Mixed-effect model with repeated measure|||P-value and LS mean difference were derived from MMRM model with change from baseline in FeNO up to Week 12 as the response variable, and treatment, age, weight group, region, baseline eosinophil level, baseline ICS dose level, visit, treatment by-visit interaction, baseline FeNO value and baseline-by-visit interaction as covariates.||-16.59|-24.60|<0.0001
72423944|NCT02948959|144358811|SUPERIORITY|Testing was performed according to the hierarchical testing procedure (continued only if the previous endpoint was statistically significant).|LS mean difference|-17.84|||<|0.0001|TWO_SIDED|95.0|-21.05|-14.63||Threshold for statistical significance at 5% significant level.|Mixed-effect model with repeated measure|||P-value and LS mean difference were derived from MMRM model with change from baseline in FeNO up to Week 12 as the response variable, and treatment, age, weight group, region, baseline eosinophil level, baseline ICS dose level, visit, treatment by-visit interaction, baseline FeNO value and baseline-by-visit interaction as covariates.||-14.63|-21.05|<0.0001
72423945|NCT01350141|144358861|SUPERIORITY_OR_OTHER||Least Squares (LS) Mean Difference|-21.81|STANDARD_ERROR_OF_MEAN|8.385||0.0137|TWO_SIDED|95.0|-38.85|-4.77|||ANCOVA|||Analysis was performed using analysis of covariance (ANCOVA) model with treatment, background statin as independent factors and treatment by background statin interaction, baseline LDL-C as covariate.||-4.77|-38.85|0.0137
72423946|NCT01350141|144358861|SUPERIORITY_OR_OTHER||LS Mean Difference|-46.42|STANDARD_ERROR_OF_MEAN|8.463|<|0.0001|TWO_SIDED|95.0|-63.62|-29.22|||ANCOVA|||Analysis was performed using ANCOVA model with treatment, background statin as independent factors and treatment by background statin interaction, baseline LDL-C as covariate.||-29.22|-63.62|<0.0001
72423947|NCT01350141|144358862|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|7.825||||0.19|TWO_SIDED|95.0|0.36|169.74|||Regression, Logistic|||Day 29 less than 70 mg/dL: Analysis was performed using logistic regression with covariates baseline LDL-C and statin tested along with the treatment.||169.74|0.36|0.1900
72423948|NCT01350141|144358862|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|72.518||||0.0057|TWO_SIDED|95.0|3.48|1512.1|||Regression, Logistic|||Day 29 less than 70 mg/dL: Analysis was performed using logistic regression with covariates baseline LDL-C and statin tested along with the treatment.||1512.10|3.48|0.0057
72423949|NCT01350141|144358862|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|24.75||||0.0013|TWO_SIDED|95.0|3.49|175.63|||Regression, Logistic|||Day 29 less than 100 mg/dL: Analysis was performed using logistic regression with covariates baseline LDL-C and statin tested along with the treatment.||175.63|3.49|0.0013
72423950|NCT01350141|144358862|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|47.326||||0.0006|TWO_SIDED|95.0|5.26|426.01|||Regression, Logistic|||Day 29 less than 100 mg/dL: Analysis was performed using logistic regression with covariates baseline LDL-C and statin tested along with the treatment.||426.01|5.26|0.0006
72423951|NCT01350141|144358862|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.635||||0.6611|TWO_SIDED|95.0|0.18|14.73|||Regression, Logistic|||Day 57 less than 70 mg/dL: Analysis was performed using logistic regression with covariates baseline LDL-C and statin tested along with the treatment.||14.73|0.18|0.6611
72333462|NCT03817463|144191585|OTHER||Adjusted Hazard Ratio|0.54|||<|0.005|TWO_SIDED|95.0|0.46|0.64|||Cox proportional hazard model|Cox proportional hazard model adjusted for unbalanced propensity score (PS)-variables at baseline.||||0.64|0.46|<0.005
72333463|NCT03817463|144191585|OTHER||Adjusted Hazard Ratio|0.56|||<|0.005|TWO_SIDED|95.0|0.47|0.66|||Cox proportional hazard model|Cox proportional hazard model adjusted for unbalanced propensity score (PS)-variables at baseline.||||0.66|0.47|<0.005
72333464|NCT03817463|144191586|OTHER||Adjusted Hazard Ratio|0.95||||0.545|TWO_SIDED|95.0|0.81|1.11|||Cox proportional hazard model|Cox proportional hazard model adjusted for unbalanced propensity score (PS)-variables at baseline.||||1.11|0.81|0.545
72333465|NCT03817463|144191586|OTHER||Adjusted Hazard Ratio|0.91||||0.036|TWO_SIDED|95.0|0.83|0.99|||Cox proportional hazard model|Cox proportional hazard model adjusted for unbalanced propensity score (PS)-variables at baseline.||||0.99|0.83|0.036
72333466|NCT03817463|144191587|OTHER||Adjusted Hazard Ratio|0.93||||0.353|TWO_SIDED|95.0|0.79|1.09|||Cox proportional hazard model|Cox proportional hazard model adjusted for unbalanced propensity score (PS)-variables at baseline.||Hazards ratios reported include data from all countries with non-missing values.||1.09|0.79|0.353
72333467|NCT03817463|144191587|OTHER||Adjusted Hazard Ratio|0.9||||0.197|TWO_SIDED|95.0|0.78|1.05|||Cox proportional hazard model|Cox proportional hazard model adjusted for unbalanced propensity score (PS)-variables at baseline.||Hazards ratios reported include data from all countries with non-missing values.||1.05|0.78|0.197
72333468|NCT03817463|144191588|OTHER||Adjusted Hazard Ratio|0.43|||<|0.005|TWO_SIDED|95.0|0.3|0.63|||Cox proportional hazard model|Cox proportional hazard model adjusted for unbalanced propensity score (PS)-variables at baseline.||Hazards ratios reported include data from all countries with non-missing values.||0.63|0.30|<0.005
72333469|NCT03817463|144191588|OTHER||Adjusted Hazard Ratio|0.27|||<|0.005|TWO_SIDED|95.0|0.16|0.44|||Cox proportional hazard model|Cox proportional hazard model adjusted for unbalanced propensity score (PS)-variables at baseline.||Hazards ratios reported include data from all countries with non-missing values.||0.44|0.16|<0.005
72333470|NCT03817463|144191589|OTHER||Adjusted Hazard Ratio|1.05||||0.535|TWO_SIDED|95.0|0.89|1.25|||Cox proportional hazard model|Cox proportional hazard model adjusted for unbalanced propensity score (PS)-variables at baseline.||||1.25|0.89|0.535
72333471|NCT03817463|144191589|OTHER||Adjusted Hazard Ratio|0.98||||0.85|TWO_SIDED|95.0|0.84|1.15|||Cox proportional hazard model|Cox proportional hazard model adjusted for unbalanced propensity score (PS)-variables at baseline.||||1.15|0.84|0.850
72333472|NCT03817463|144191590|OTHER||Adjusted Hazard Ratio|1.03||||0.828|TWO_SIDED|95.0|0.81|1.31|||Cox proportional hazard model|Cox proportional hazard model adjusted for unbalanced propensity score (PS)-variables at baseline.||Hazards ratios reported include data from all countries with non-missing values.||1.31|0.81|0.828
72333473|NCT03817463|144191590|OTHER||Adjusted Hazard Ratio|1.01||||0.944|TWO_SIDED|95.0|0.72|1.42|||Cox proportional hazard model|Cox proportional hazard model adjusted for unbalanced propensity score (PS)-variables at baseline.||Hazards ratios reported include data from all countries with non-missing values.||1.42|0.72|0.944
72333474|NCT03817463|144191591|OTHER||Adjusted Hazard Ratio|0.94||||0.642|TWO_SIDED|95.0|0.73|1.22|||Cox proportional hazard model|Cox proportional hazard model adjusted for unbalanced propensity score (PS)-variables at baseline.||||1.22|0.73|0.642
72333475|NCT03817463|144191591|OTHER||Adjusted Hazard Ratio|0.89||||0.417|TWO_SIDED|95.0|0.66|1.19|||Cox proportional hazard model|Cox proportional hazard model adjusted for unbalanced propensity score (PS)-variables at baseline.||||1.19|0.66|0.417
72423952|NCT01350141|144358862|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|13.486||||0.0104|TWO_SIDED|95.0|1.84|98.61|||Regression, Logistic|||Day 57 less than 70 mg/dL: Analysis was performed using logistic regression with covariates baseline LDL-C and statin tested along with the treatment.||98.61|1.84|0.0104
72423953|NCT01350141|144358862|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.43||||0.0282|TWO_SIDED|95.0|1.22|33.89|||Regression, Logistic|||Day 57 less than 100 mg/dL: Analysis was performed using logistic regression with covariates baseline LDL-C and statin tested along with the treatment.||33.89|1.22|0.0282
72423954|NCT01350141|144358862|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|15.257||||0.0042|TWO_SIDED|95.0|2.36|98.42|||Regression, Logistic|||Day 57 less than 100 mg/dL: Analysis was performed using logistic regression with covariates baseline LDL-C and statin tested along with the treatment.||98.42|2.36|0.0042
72423955|NCT01350141|144358862|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.967||||0.5164|TWO_SIDED|95.0|0.11|79.24|||Regression, Logistic|||Day 85 less than 70 mg/dL: Analysis was performed using logistic regression with covariates baseline LDL-C and statin tested along with the treatment.||79.24|0.11|0.5164
72333476|NCT03817463|144191592|OTHER||Adjusted Hazard Ratio|0.89||||0.091|TWO_SIDED|95.0|0.77|1.02|||Cox proportional hazard model|Cox proportional hazard model adjusted for unbalanced propensity score (PS)-variables at baseline.||Hazards ratios reported include data from all countries with non-missing values.||1.02|0.77|0.091
72333477|NCT03817463|144191593|OTHER||Adjusted Hazard Ratio|1.97|||<|0.005|TWO_SIDED|95.0|1.28|3.03|||Cox proportional hazard model|Cox proportional hazard model adjusted for unbalanced propensity score (PS)-variables at baseline.||Hazards ratios reported include data from all countries with non-missing values.||3.03|1.28|<0.005
72333478|NCT03817463|144191594|OTHER||Adjusted Hazard Ratio|0.95||||0.654|TWO_SIDED|95.0|0.75|1.2|||Cox proportional hazard model|Cox proportional hazard model adjusted for unbalanced propensity score (PS)-variables at baseline.||Hazards ratios reported include data from all countries with non-missing values.||1.20|0.75|0.654
72333479|NCT03817463|144191595|OTHER||Adjusted Hazard Ratio|0.78||||0.233|TWO_SIDED|95.0|0.52|1.17|||Cox proportional hazard model|Cox proportional hazard model adjusted for unbalanced propensity score (PS)-variables at baseline.||Hazards ratios reported include data from all countries with non-missing values.||1.17|0.52|0.233
72333480|NCT03817463|144191596|OTHER||Adjusted Hazard Ratio|0.56|||<|0.005|TWO_SIDED|95.0|0.38|0.82|||Cox proportional hazard model|Cox proportional hazard model adjusted for unbalanced propensity score (PS)-variables at baseline.||Hazards ratios reported include data from all countries with non-missing values.||0.82|0.38|<0.005
72333481|NCT03817463|144191597|OTHER||Rate Ratio|0.74|||||TWO_SIDED|95.0|0.69|0.8|||||Poisson regression model was used.|Emergency room visits - Finland||0.80|0.69|
72333482|NCT03817463|144191597|OTHER||Rate Ratio|0.9|||||TWO_SIDED|95.0|0.59|1.38|||||Poisson regression model was used.|Emergency room visits - Japan||1.38|0.59|
72333483|NCT03817463|144191597|OTHER||Rate Ratio|0.91|||||TWO_SIDED|95.0|0.82|1.0|||||Poisson regression model was used.|Emergency room visits - South Korea||1.00|0.82|
72333484|NCT03817463|144191597|OTHER||Rate Ratio|0.72|||||TWO_SIDED|95.0|0.59|0.87|||||Poisson regression model was used.|Emergency room visit - Spain||0.87|0.59|
72333485|NCT03817463|144191597|OTHER||Rate Ratio|0.94|||||TWO_SIDED|95.0|0.87|1.01|||||Poisson regression model was used.|Emergency room visit - Sweden||1.01|0.87|
72333486|NCT03817463|144191597|OTHER||Rate Ratio|0.86|||||TWO_SIDED|95.0|0.8|0.93|||||Poisson regression model was used.|Emergency room visit - Taiwan||0.93|0.80|
72423956|NCT01350141|144358862|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|21.36||||0.0445|TWO_SIDED|95.0|1.08|422.94|||Regression, Logistic|||Day 85 less than 70 mg/dL: Analysis was performed using logistic regression with covariates baseline LDL-C and statin tested along with the treatment.||422.94|1.08|0.0445
72423957|NCT01350141|144358862|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|8.157||||0.0223|TWO_SIDED|95.0|1.35|49.37|||Regression, Logistic|||Day 85 less than 100 mg/dL: Analysis was performed using logistic regression with covariates baseline LDL-C and statin tested along with the treatment.||49.37|1.35|0.0223
72423958|NCT01350141|144358862|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|13.587||||0.007|TWO_SIDED|95.0|2.04|90.4|||Regression, Logistic|||Day 85 less than 100 mg/dL: Analysis was performed using logistic regression with covariates baseline LDL-C and statin tested along with the treatment.||90.40|2.04|0.0070
72423959|NCT01350141|144358863|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.647||||0.2928|TWO_SIDED|95.0|0.22|142.04|||Regression, Logistic|||Day 29: Analysis was performed using logistic regression with covariates baseline LDL-C and statin tested along with the treatment.||142.04|0.22|0.2928
72423960|NCT01350141|144358863|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|591.174||||0.0014|TWO_SIDED|95.0|11.68|29922.99|||Regression, Logistic|||Day 29: Analysis was performed using logistic regression with covariates baseline LDL-C and statin tested along with the treatment.||29922.99|11.68|0.0014
72423961|NCT01350141|144358863|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.468||||0.2339|TWO_SIDED|95.0|0.45|26.88|||Regression, Logistic|||Day 57: Analysis was performed using logistic regression with covariates baseline LDL-C and statin tested along with the treatment.||26.88|0.45|0.2339
72423962|NCT01350141|144358863|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|23.442||||0.0025|TWO_SIDED|95.0|3.03|181.11|||Regression, Logistic|||Day 57: Analysis was performed using logistic regression with covariates baseline LDL-C and statin tested along with the treatment.||181.11|3.03|0.0025
72423963|NCT01350141|144358863|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|8.502||||0.1786|TWO_SIDED|95.0|0.38|192.32|||Regression, Logistic|||Day 85: Analysis was performed using logistic regression with covariates baseline LDL-C and statin tested along with the treatment.||192.32|0.38|0.1786
72423964|NCT01350141|144358863|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|51.185||||0.0121|TWO_SIDED|95.0|2.37|1107.57|||Regression, Logistic|||Day 85: Analysis was performed using logistic regression with covariates baseline LDL-C and statin tested along with the treatment.||1107.57|2.37|0.0121
72423965|NCT01588990|144358875|SUPERIORITY_OR_OTHER|||||||0.101|||||||Cox Proportional Hazards Model|||||||0.101
72423966|NCT01588990|144358887|SUPERIORITY_OR_OTHER|||||||0.052|||||||Cox Proportional Hazards Model|||||||0.052
72423967|NCT01588990|144358888|SUPERIORITY_OR_OTHER|||||||0.797|||||||Cox Proportional Hazards Model|||||||0.797
72423968|NCT01588990|144358889|SUPERIORITY_OR_OTHER|||||||0.188|||||||Cox Proportional Hazards Model|||||||0.188
72423969|NCT01588990|144358890|SUPERIORITY_OR_OTHER|||||||0.016|||||||Cox Proportional Hazards Model|||||||0.016
72423970|NCT02367716|144358905|OTHER|The mean change in QRS duration between Baseline and 6 months|Mean Difference (Final Values)|-13.9|STANDARD_DEVIATION|29.6|||TWO_SIDED|||||||||||||
72423971|NCT03097861|144358931|OTHER|Treatment p-value is from ANCOVA using SBM count as dependent variable, treatment as fixed effect and baseline count as random effect|||||=|0.002|||||||ANCOVA|||||||=0.0020
72423972|NCT03097861|144358931|OTHER||||||<|0.0001|||||||ANCOVA|||Treatment p-value is from ANCOVA using SBM count as dependent variable, treatment as fixed effect and baseline count as random effect||||<0.0001
72423973|NCT01187329|144358944|SUPERIORITY||Mean Difference (Final Values)|-1.2||||0.11|TWO_SIDED|97.5|-2.87|0.48|||t-test, 2 sided|||||0.48|-2.87|0.11
72423974|NCT01187329|144358945|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.007|TWO_SIDED|97.5|-0.3|-0.01|||t-test, 2 sided|paired t-test||||-0.01|-0.3|0.007
72423975|NCT01187329|144358946|SUPERIORITY||Median Difference (Final Values)|-0.6||||0.57|TWO_SIDED|95.0|-2.6|1.5|||t-test, 2 sided|||||1.5|-2.6|0.57
72423976|NCT01187329|144358947|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.45|TWO_SIDED|95.0|-0.2|0.1|||t-test, 2 sided|||||0.1|-0.2|0.45
72423977|NCT00868699|144358950|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.6|STANDARD_ERROR_OF_MEAN|1.17|<|0.001|||||||Mixed Models Analysis||A negative difference in least square mean change from baseline between Lurasidone group and placebo indicates a greater improvement in the Lurasidone group over the placebo group.|||||<0.001
72423978|NCT00868699|144358950|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.6|STANDARD_ERROR_OF_MEAN|1.17|<|0.001|||||||Mixed Models Analysis||A negative difference in least square mean change from baseline between Lurasidone group and placebo indicates a greater improvement in the Lurasidone group over the placebo group.|||||<0.001
72423979|NCT00868699|144358951|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.69|STANDARD_ERROR_OF_MEAN|0.143|<|0.001|||||||Mixed Models Analysis||A negative difference in least square mean change from baseline between Lurasidone group and placebo indicates a greater improvement in the Lurasidone group over the placebo group.|||||<0.001
72423980|NCT00868699|144358951|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.57|STANDARD_ERROR_OF_MEAN|0.143|<|0.001|||||||Mixed Models Analysis||A negative difference in least square mean change from baseline between Lurasidone group and placebo indicates a greater improvement in the Lurasidone group over the placebo group.|||||<0.001
72423981|NCT00868699|144358952|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.1|STANDARD_ERROR_OF_MEAN|1.05||0.003|||||||ANCOVA||A negative difference in least square mean change from baseline between Lurasidone group and placebo indicates a greater improvement in the Lurasidone group over the placebo group.|||||0.003
72423982|NCT00868699|144358952|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.5|STANDARD_ERROR_OF_MEAN|1.01|<|0.001|||||||ANCOVA||A negative difference in least square mean change from baseline between Lurasidone group and placebo indicates a greater improvement in the Lurasidone group over the placebo group.|||||<0.001
72423983|NCT03885011|144358977|SUPERIORITY||Odds Ratio (OR)|1.103||||0.8445|TWO_SIDED|95.0|0.413|2.949|||Regression, Logistic|||This analysis relates to Day 8 up to when pilocarpine HCl 0.2% either in CSF-1-FDC or as pilocarpine alone was administered for one week.||2.949|0.413|0.8445
72423984|NCT03885011|144358977|SUPERIORITY||Odds Ratio (OR)|1.646||||0.266|TWO_SIDED|95.0|0.684|3.958|||Regression, Logistic|||||3.958|0.684|0.2660
72423985|NCT03885011|144358978|SUPERIORITY||Odds Ratio (OR)|3.664||||0.0015|TWO_SIDED|95.0|1.646|8.154|||Regression, Logistic|||||8.154|1.646|0.0015
72423986|NCT03885011|144358978|SUPERIORITY||Odds Ratio (OR)|4.745||||0.0002|TWO_SIDED|95.0|2.088|10.786|||Regression, Logistic|||||10.786|2.088|0.0002
72333487|NCT03817463|144191597|OTHER||Hazard Ratio (HR)|0.8|||||TWO_SIDED|95.0|0.75|0.85|||||HR and confidence interval were estimated using a cox proportional hazard model, comparing treatment groups and adjusting for unbalanced propensity score (PS)-variables.|First impatient stay - Finland||0.85|0.75|
72333488|NCT03817463|144191597|OTHER||Hazard Ratio (HR)|0.76|||||TWO_SIDED|95.0|0.68|0.84|||||HR and confidence interval were estimated using a cox proportional hazard model, comparing treatment groups and adjusting for unbalanced propensity score (PS)-variables.|First impatient stay - Japan||0.84|0.68|
72333489|NCT03817463|144191597|OTHER||Hazard Ratio (HR)|0.75|||||TWO_SIDED|95.0|0.69|0.82|||||HR and confidence interval were estimated using a cox proportional hazard model, comparing treatment groups and adjusting for unbalanced propensity score (PS)-variables.|First impatient stay - South Korea||0.82|0.69|
72333490|NCT03817463|144191597|OTHER||Hazard Ratio (HR)|0.86|||||TWO_SIDED|95.0|0.78|0.94|||||HR and confidence interval were estimated using a cox proportional hazard model, comparing treatment groups and adjusting for unbalanced propensity score (PS)-variables.|First impatient stay - Norway||0.94|0.78|
72333491|NCT03817463|144191597|OTHER||Hazard Ratio (HR)|0.77|||||TWO_SIDED|95.0|0.66|0.89|||||HR and confidence interval were estimated using a cox proportional hazard model, comparing treatment groups and adjusting for unbalanced propensity score (PS)-variables.|First impatient stay - Spain||0.89|0.66|
72333492|NCT03817463|144191597|OTHER||Hazard Ratio (HR)|0.87|||||TWO_SIDED|95.0|0.81|0.93|||||HR and confidence interval were estimated using a cox proportional hazard model, comparing treatment groups and adjusting for unbalanced propensity score (PS)-variables.|First impatient stay - Sweden||0.93|0.81|
72333493|NCT03817463|144191597|OTHER||Hazard Ratio (HR)|0.8|||||TWO_SIDED|95.0|0.74|0.86|||||HR and confidence interval were estimated using a cox proportional hazard model, comparing treatment groups and adjusting for unbalanced propensity score (PS)-variables.|First impatient stay - Taiwan||0.86|0.74|
72333494|NCT03817463|144191597|OTHER||Rate Ratio|0.68|||||TWO_SIDED|95.0|0.64|0.71|||||Poisson regression model was used.|All-cause hospital admissions||0.71|0.64|
72333495|NCT03817463|144191597|OTHER||Rate Ratio|0.69|||||TWO_SIDED|95.0|0.63|0.76|||||Poisson regression model was used.|For all-cause hospital admissions - Japan||0.76|0.63|
72333496|NCT03817463|144191597|OTHER||Rate Ratio|0.7|||||TWO_SIDED|95.0|0.66|0.75|||||Poisson regression model was used.|All-cause hospital admissions - South Korea||0.75|0.66|
72333497|NCT03817463|144191597|OTHER||Rate Ratio|0.81|||||TWO_SIDED|95.0|0.77|0.85|||||Poisson regression model was used.|All-cause hospital admissions - Norway||0.85|0.77|
72333498|NCT03817463|144191597|OTHER||Rate Ratio|0.68|||||TWO_SIDED|95.0|0.6|0.77|||||Poisson regression model was used.|All-cause hospital admissions - Spain||0.77|0.60|
72333499|NCT03817463|144191597|OTHER||Rate Ratio|0.85|||||TWO_SIDED|95.0|0.8|0.89|||||Poisson regression model was used.|All-cause hospital admissions - Sweden||0.89|0.80|
72333500|NCT03817463|144191597|OTHER||Rate Ratio|0.79|||||TWO_SIDED|95.0|0.72|0.87||||||All-cause hospital admissions - Taiwan||0.87|0.72|
72333501|NCT03817463|144191597|OTHER||Rate Ratio|0.78|||||TWO_SIDED|95.0|0.77|0.79|||||Poisson regression model was used.|Outpatient healthcare visits - Finland||0.79|0.77|
72333502|NCT03817463|144191597|OTHER||Rate Ratio|0.95|||||TWO_SIDED|95.0|0.94|0.97|||||Poisson regression model was used.|Outpatient healthcare visits - Japan||0.97|0.94|
72333503|NCT03817463|144191597|OTHER||Rate Ratio|0.97|||||TWO_SIDED|95.0|0.96|0.97|||||Poisson regression model was used.|Outpatient healthcare visits - South Korea||0.97|0.96|
72333504|NCT03817463|144191597|OTHER||Rate Ratio|0.96|||||TWO_SIDED|95.0|0.94|0.97||||||Outpatient healthcare visits - Norway||0.97|0.94|
72333505|NCT03817463|144191597|OTHER||Rate Ratio|0.88|||||TWO_SIDED|95.0|0.85|0.91|||||Poisson regression model was used.|Outpatient healthcare visit - Spain||0.91|0.85|
72333506|NCT03817463|144191597|OTHER||Rate Ratio|0.96|||||TWO_SIDED|95.0|0.94|0.98|||||Poisson regression model was used.|Outpatient healthcare visits - Sweden||0.98|0.94|
72333507|NCT03817463|144191597|OTHER||Rate Ratio|0.97|||||TWO_SIDED|95.0|0.94|1.0|||||Poisson regression model was used.|Outpatient healthcare visits - Taiwan||1.00|0.94|
72333508|NCT03817463|144191598|OTHER||Rate Ratio|0.91|||||TWO_SIDED|95.0|0.89|0.94|||||Poisson regression model was used.|Pharmacy dispensations/prescriptions based on different antidiabetic drugs - Japan||0.94|0.89|
72333509|NCT03817463|144191598|OTHER||Rate Ratio|0.86|||||TWO_SIDED|95.0|0.81|0.93|||||Poisson regression model was used.|Pharmacy dispensations/prescriptions based on different antidiabetic drugs - South Korea||0.93|0.81|
72333510|NCT03817463|144191598|OTHER||Rate Ratio|1.09|||||TWO_SIDED|95.0|1.08|1.11|||||Poisson regression model was used.|Pharmacy dispensations/prescriptions based on different antidiabetic drugs - Taiwan||1.11|1.08|
72333511|NCT03817463|144191598|OTHER||Rate Ratio|1.11|||||TWO_SIDED|95.0|1.1|1.12|||||Poisson regression model was used.|Pharmacy dispensations/prescriptions based on different drugs - Finland||1.12|1.10|
72333512|NCT03817463|144191598|OTHER||Rate Ratio|0.82|||||TWO_SIDED|95.0|0.81|0.83|||||Poisson regression model was used.|Pharmacy dispensations/prescriptions based on different drugs - Japan||0.83|0.81|
72333513|NCT03817463|144191598|OTHER||Rate Ratio|0.99|||||TWO_SIDED|95.0|0.99|1.0|||||Poisson regression model was used.|Pharmacy dispensations/prescriptions based on different drugs - South Korea||1.00|0.99|
72333514|NCT03817463|144191598|OTHER||Rate Ratio|1.12|||||TWO_SIDED|95.0|1.11|1.14|||||Poisson regression model was used.|Pharmacy dispensations/prescriptions based on different drugs - Norway||1.14|1.11|
72333515|NCT03817463|144191598|OTHER||Rate Ratio|1.26|||||TWO_SIDED|95.0|1.25|1.27|||||Poisson regression model was used.|Pharmacy dispensations/prescriptions based on different drugs - Sweden||1.27|1.25|
72333516|NCT03817463|144191598|OTHER||Rate Ratio|1.0|||||TWO_SIDED|95.0|0.98|1.02|||||Poisson regression model was used.|Pharmacy dispensations/prescriptions based on different drugs - Taiwan||1.02|0.98|
72333517|NCT03817463|144191598|OTHER||Rate Ratio|1.01|||||TWO_SIDED|95.0|1.01|1.02|||||Poisson regression model was used.|Pharmacy dispensations/prescriptions based on prescriptions - Finland||1.02|1.01|
72333518|NCT03817463|144191598|OTHER||Rate Ratio|0.83|||||TWO_SIDED|95.0|0.82|0.84|||||Poisson regression model was used.|Pharmacy dispensations/prescriptions based on prescriptions - Japan||0.84|0.82|
72333519|NCT03817463|144191598|OTHER||Rate Ratio|1.0|||||TWO_SIDED|95.0|0.99|1.01|||||Poisson regression model was used.|Pharmacy dispensations/prescriptions based on prescriptions - South Korea||1.01|0.99|
72333520|NCT03817463|144191598|OTHER||Rate Ratio|0.93|||||TWO_SIDED|95.0|0.92|0.93|||||Poisson regression model was used.|Pharmacy dispensations/prescriptions based on prescriptions - Norway||0.93|0.92|
72333521|NCT03817463|144191598|OTHER||Rate Ratio|0.86|||||TWO_SIDED|95.0|0.84|0.87|||||Poisson regression model was used.|Pharmacy dispensations/prescriptions based on prescriptions - Spain||0.87|0.84|
72333522|NCT03817463|144191598|OTHER||Rate Ratio|1.0|||||TWO_SIDED|95.0|1.0|1.0|||||Poisson regression model was used.|Pharmacy dispensations/prescriptions based on prescriptions - Sweden||1.00|1.00|
72333523|NCT03817463|144191599|OTHER||Rate Ratio|0.89|||||TWO_SIDED|95.0|0.83|0.94|||||Poisson regression model was used.|Total cost - Finland||0.94|0.83|
72333524|NCT03817463|144191599|OTHER||Rate Ratio|0.98|||||TWO_SIDED|95.0|0.86|1.12|||||Poisson regression model was used.|Total costs - Norway||1.12|0.86|
72333525|NCT03817463|144191599|OTHER||Rate Ratio|0.98|||||TWO_SIDED|95.0|0.92|1.05|||||Poisson regression model was used.|Total costs - Sweden||1.05|0.92|
72333526|NCT03817463|144191600|OTHER||Rate Ratio|0.84|||||TWO_SIDED|95.0|0.8|0.88|||||Poisson regression model was used.|||0.88|0.80|
72333527|NCT03817463|144191601|OTHER||Rate Ratio|0.76|||||TWO_SIDED|95.0|0.34|1.68|||||Poisson regression model was used.|Total costs - South Korea||1.68|0.34|
72333528|NCT03817463|144191602|OTHER||Rate Ratio|0.97|||||TWO_SIDED|95.0|0.92|1.03|||||Poisson regression model was used.|Total costs - Taiwan||1.03|0.92|
72333529|NCT01559259|144191634|SUPERIORITY_OR_OTHER_LEGACY||Least Square (LS) Mean difference|26.28|||<|0.001|TWO_SIDED|95.0|20.33|32.22|||ANOVA|||Treatment difference and 95 percent (%) Confidence interval (CI) were based on Least square mean (LSM) from analysis of variance (ANOVA) with treatment, baseline categorical pain severity rating (PSR), gender and treatment-by-baseline categorical PSR terms used as covariates.||32.22|20.33|<0.001
72333530|NCT01559259|144191634|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|24.37|||<|0.001|TWO_SIDED|95.0|18.44|30.29|||ANOVA|||Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||30.29|18.44|<0.001
72333531|NCT01559259|144191634|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|27.48|||<|0.001|TWO_SIDED|95.0|21.53|33.42|||ANOVA|||Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||33.42|21.53|<0.001
72333532|NCT01559259|144191634|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|24.85|||<|0.001|TWO_SIDED|95.0|18.93|30.78|||ANOVA|||Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||30.78|18.93|<0.001
72333533|NCT01559259|144191634|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.42||||0.501|TWO_SIDED|95.0|-2.73|5.58|||ANOVA|||Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||5.58|-2.73|0.501
72333534|NCT01559259|144191634|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.49||||0.817|TWO_SIDED|95.0|-4.61|3.64|||ANOVA|||Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||3.64|-4.61|0.817
72333535|NCT01559259|144191634|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.62||||0.216|TWO_SIDED|95.0|-1.53|6.78|||ANOVA|||Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||6.78|-1.53|0.216
72333536|NCT01559259|144191635|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|12.69|||<|0.001|TWO_SIDED|95.0|5.52|29.19|||Proportional hazards model|||Hazard ratio (HR) and corresponding 95% CI were calculated based on the Wald statistic from the proportional hazards (PH) model with treatment, baseline categorical PSR and gender terms used as covariates.||29.19|5.52|<0.001
72333537|NCT01559259|144191635|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|10.02|||<|0.001|TWO_SIDED|95.0|4.36|23.02|||Proportional hazards model|||Hazard ratio (HR) and corresponding 95% CI were calculated based on the Wald statistic from the proportional hazards (PH) model with treatment, baseline categorical PSR and gender terms used as covariates.||23.02|4.36|<0.001
72333538|NCT01559259|144191635|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|11.66|||<|0.001|TWO_SIDED|95.0|5.07|26.83|||Proportional hazards model|||Hazard ratio (HR) and corresponding 95% CI were calculated based on the Wald statistic from the proportional hazards (PH) model with treatment, baseline categorical PSR and gender terms used as covariates.||26.83|5.07|<0.001
72333539|NCT01559259|144191635|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|8.6|||<|0.001|TWO_SIDED|95.0|3.74|19.77|||Proportional hazards model|||Hazard ratio (HR) and corresponding 95% CI were calculated based on the Wald statistic from the proportional hazards (PH) model with treatment, baseline categorical PSR and gender terms used as covariates.||19.77|3.74|<0.001
72333540|NCT01559259|144191635|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.48||||0.014|TWO_SIDED|95.0|1.08|2.02|||Proportional hazards model|||Hazard ratio (HR) and corresponding 95% CI were calculated based on the Wald statistic from the proportional hazards (PH) model with treatment, baseline categorical PSR and gender terms used as covariates.||2.02|1.08|0.014
72333541|NCT01559259|144191635|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.17||||0.332|TWO_SIDED|95.0|0.86|1.59|||Proportional hazards model|||Hazard ratio (HR) and corresponding 95% CI were calculated based on the Wald statistic from the proportional hazards (PH) model with treatment, baseline categorical PSR and gender terms used as covariates.||1.59|0.86|0.332
72423987|NCT03885011|144358979|SUPERIORITY|||||||0.1145|||||||Chi-squared|||||||0.1145
72423988|NCT03885011|144358979|SUPERIORITY|||||||0.0616|||||||Chi-squared|||||||0.0616
72423989|NCT03885011|144358980|SUPERIORITY|||||||0.0074|||||||Chi-squared|||||||0.0074
72423990|NCT03885011|144358980|SUPERIORITY|||||||0.0001|||||||Chi-squared|||||||0.0001
72423991|NCT05266963|144358981|SUPERIORITY|Statistical analysis will be performed using a paired samples Wilcoxon test to compare differences between the two groups.||||||0.43|||||||Wilcoxon (Mann-Whitney)|Wilcoxon matched-pairs||||||0.43
72423992|NCT05266963|144358982|SUPERIORITY|Statistical analysis will be performed using a standard two-tailed t test to compare differences between the two groups.||||||0.52|||||||t-test, 2 sided|||||||0.52
72423993|NCT01725386|144358987|SUPERIORITY_OR_OTHER|||||||0.895|||||||Log Rank (Mantel-Cox)|||||||0.895
72423994|NCT00152009|144358991|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0006||95.0|||||ANCOVA|Employed Dunnett's adjustment for multiple pairwise comparisons. Corresponding baseline efficacy scores obtained were used as covariates.||||||0.0006
72423995|NCT00152009|144358991|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0005||95.0|||||ANCOVA|Employed Dunnett's adjustment for multiple pairwise comparisons. Corresponding baseline efficacy scores obtained were used as covariates.||||||0.0005
72423996|NCT00152009|144358991|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||ANCOVA|Employed Dunnett's adjustment for multiple pairwise comparisons. Corresponding baseline efficacy scores obtained were used as covariates.||||||<0.0001
72423997|NCT00152009|144358992|SUPERIORITY_OR_OTHER_LEGACY|||||||0.025||95.0|||||ANCOVA|Employed Dunnett's adjustment for multiple pairwise comparisons. Corresponding baseline efficacy scores obtained were used as covariates.||||||0.025
72423998|NCT00152009|144358992|SUPERIORITY_OR_OTHER_LEGACY|||||||0.035||95.0|||||ANCOVA|Employed Dunnett's adjustment for multiple pairwise comparisons. Corresponding baseline efficacy scores obtained were used as covariates.||||||0.035
72423999|NCT00152009|144358992|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||ANCOVA|Employed Dunnett's adjustment for multiple pairwise comparisons. Corresponding baseline efficacy scores obtained were used as covariates.||||||<0.0001
72424000|NCT00152009|144358993|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||ANCOVA|Employed Dunnett's adjustment for multiple pairwise comparisons. Corresponding baseline efficacy scores obtained were used as covariates.||||||<0.0001
72424001|NCT00152009|144358993|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||ANCOVA|Employed Dunnett's adjustment for multiple pairwise comparisons. Corresponding baseline efficacy scores obtained were used as covariates.||||||<0.0001
72424002|NCT00152009|144358993|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||ANCOVA|Employed Dunnett's adjustment for multiple pairwise comparisons. Corresponding baseline efficacy scores obtained were used as covariates.||||||<0.0001
72424003|NCT00152009|144358994|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||Cochran-Mantel-Haenszel|||||||<0.0001
72424004|NCT00152009|144358994|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0016||95.0|||||Cochran-Mantel-Haenszel|||||||0.0016
72424005|NCT00152009|144358994|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0001||95.0|||||Cochran-Mantel-Haenszel|||||||0.0001
72424006|NCT00152009|144358995|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||Cochran-Mantel-Haenszel|||||||<0.0001
72424007|NCT00152009|144358995|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0013||95.0|||||Cochran-Mantel-Haenszel|||||||0.0013
72424008|NCT00152009|144358995|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||Cochran-Mantel-Haenszel|||||||<0.0001
72424009|NCT00152009|144358996|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1438||95.0|||||ANCOVA|Employed Dunnett's adjustment for multiple pairwise comparisons. Corresponding baseline efficacy scores obtained were used as covariates.||Psychosocial category||||0.1438
72424010|NCT00152009|144358996|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1426||95.0|||||ANCOVA|Employed Dunnett's adjustment for multiple pairwise comparisons. Corresponding baseline efficacy scores obtained were used as covariates.||Psychosocial category||||0.1426
72424011|NCT00152009|144358996|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0191||95.0|||||ANCOVA|Employed Dunnett's adjustment for multiple pairwise comparisons. Corresponding baseline efficacy scores obtained were used as covariates.||Psychosocial category||||0.0191
72424012|NCT00393523|144359018|SUPERIORITY_OR_OTHER||Seroprotection rate (SPR)|95.0|||<|0.001||95.2|92.1|97.1||"Adequate SPR required the lower bound of the 95.2% CI for the SPR for subjects in both Group 1 and Group 2 to be \> 90% (P-Value \< .024).~Since only one group met the criteria, that group was retested at α=.012."|Hochberg's step up|The primary hypothesis was evaluated using Hochberg's step up approach to control multiplicity.|Seroprotection rate (SPR)- defined as the percentage of subjects who demonstrate antibodies to hepatitis B surface antigen ≥10 mIU/mL|The primary purpose of this study was to show that subjects who received a primary series of RECOMBIVAX HB™ in the first year of life were adequately protected by RECOMBIVAX HB™ by measuring the immune response to a single booster dose of either a modified process vaccine or ENGERIX-B™.||97.1|92.1|<0.001
72424013|NCT00393523|144359018|SUPERIORITY_OR_OTHER||Seroprotection rate (SPR)|95.0|||<|0.001||97.6|91.6|97.3||Adequate SPR required the lower bound of the 95.2% CI for the SPR for subjects in both Group 1 and Group 2 to be \> 90% (P-Value \< .024). Since only one group met the criteria, that group was retested at α=.012.|Hochberg's step up|The primary hypothesis was evaluated using Hochberg's step up approach to control multiplicity.|Seroprotection rate (SPR)- defined as the percentage of subjects who demonstrate antibodies to hepatitis B surface antigen ≥10 mIU/mL|The primary purpose of this study was to show that subjects who received a primary series of RECOMBIVAX HB™ in the first year of life were adequately protected by RECOMBIVAX HB™ by measuring the immune response to a single booster dose of either a modified process vaccine or ENGERIX-B™.||97.3|91.6|<0.001
72424014|NCT00393523|144359018|SUPERIORITY_OR_OTHER||Seroprotection rate (SPR)|91.6||||0.19||95.2|88.0|94.4||"Adequate SPR required the lower bound of the 95.2% CI for the SPR for subjects in both Group 1 and Group 2 to be \> 90% (P-Value \< .024).~Since only one group met the criteria, that group was retested at α=.012."|Hochberg's step up|The primary hypothesis was evaluated using Hochberg's step up approach to control multiplicity.|Seroprotection rate (SPR)- defined as the percentage of subjects who demonstrate antibodies to hepatitis B surface antigen ≥10 mIU/mL|The primary purpose of this study was to show that subjects who received a primary series of RECOMBIVAX HB™ in the first year of life were adequately protected by RECOMBIVAX HB™ by measuring the immune response to a single booster dose of either a modified process vaccine or ENGERIX-B™.||94.4|88.0|0.19
72424015|NCT00393523|144359019|SUPERIORITY_OR_OTHER||Seroprotection Rate (SPR)|97.3||||||95.0|95.0|98.8|||||"Exact binomial confidence interval~Seroprotection Rate (SPR)- defined as the percentage of subjects who demonstrate antibodies to hepatitis B surface antigen ≥10 mIU/mL"|The purpose of the secondary analysis is to demonstrate that there is an adequate SPR in subjects who received a primary vaccination series of ENGERIX-B™ and a booster dose of modified process hepatitis B vaccine. An adequate response requires the lower bound of the two-sided 95% confidence interval for the SPR to exceed 90%.||98.8|95.0|
72333542|NCT01559259|144191635|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.36||||0.056|TWO_SIDED|95.0|0.99|1.85|||Proportional hazards model|||Hazard ratio (HR) and corresponding 95% CI were calculated based on the Wald statistic from the proportional hazards (PH) model with treatment, baseline categorical PSR and gender terms used as covariates.||1.85|0.99|0.056
72333543|NCT01559259|144191636|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|12.1|||<|0.001|TWO_SIDED|95.0|5.24|27.91|||Proportional hazards model|||HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model with treatment, baseline categorical PSR and gender terms used as covariates.||27.91|5.24|<0.001
72333544|NCT01559259|144191636|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|8.88|||<|0.001|TWO_SIDED|95.0|3.86|20.44|||Proportional hazards model|||HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model with treatment, baseline categorical PSR and gender terms used as covariates.||20.44|3.86|<0.001
72333545|NCT01559259|144191636|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|11.47|||<|0.001|TWO_SIDED|95.0|4.98|26.42|||Proportional hazards model|||HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model with treatment, baseline categorical PSR and gender terms used as covariates.||26.42|4.98|<0.001
72333546|NCT01559259|144191636|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|8.11|||<|0.001|TWO_SIDED|95.0|3.52|18.68|||Proportional hazards model|||HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model with treatment, baseline categorical PSR and gender terms used as covariates.||18.68|3.52|<0.001
72333547|NCT01559259|144191636|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.49||||0.012|TWO_SIDED|95.0|1.09|2.04|||Proportional hazards model|||HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model with treatment, baseline categorical PSR and gender terms used as covariates.||2.04|1.09|0.012
72333548|NCT01559259|144191636|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.09||||0.57|TWO_SIDED|95.0|0.8|1.49|||Proportional hazards model|||HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model with treatment, baseline categorical PSR and gender terms used as covariates.||1.49|0.80|0.570
72333549|NCT01559259|144191636|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.41||||0.03|TWO_SIDED|95.0|1.03|1.93|||Proportional hazards model|||HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model with treatment, baseline categorical PSR and gender terms used as covariates.||1.93|1.03|0.030
72424016|NCT01515189|144359033|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.04|TWO_SIDED|95.0|0.7|0.99||Analysis stratified by ECOG performance status (0 vs. 1), prior treatment for metastatic melanoma (yes vs. no) and M-stage (M0/M1a/M1b vs. M1c without brain metastases vs. M1c with brain metastases).|Log Rank||Hazard of 10 mg/kg ipilimumab over hazard of 3 mg/kg, with 2-sided 95% confidence intervals are based on a Cox proportional hazards model|||0.99|0.70|0.0400
72424017|NCT01515189|144359034|SUPERIORITY||Hazard Ratio (HR)|0.89||||0.1548|TWO_SIDED|95.0|0.76|1.04||Analysis stratified by ECOG performance status (0 vs. 1), prior treatment for metastatic melanoma (yes vs. no) and M-stage (M0/M1a/M1b vs. M1c without brain metastases vs. M1c with brain metastases).|Log Rank||Hazard of 10 mg/kg ipilimumab over hazard of 3 mg/kg, with 2-sided 95% confidence intervals are based on a Cox proportional hazards model|||1.04|0.76|0.1548
72333550|NCT01559259|144191637|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.39||||0.014|TWO_SIDED|95.0|0.08|0.71|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.71|0.08|0.014
72333551|NCT01559259|144191637|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.33||||0.038|TWO_SIDED|95.0|0.02|0.64|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.64|0.02|0.038
72424018|NCT01515189|144359040|SUPERIORITY||Hazard Ratio (HR)|0.71|||||TWO_SIDED|95.0|0.49|1.04|||||Hazard of 10 mg/kg ipilimumab over hazard of 3 mg/kg. Based on an unstratified Cox proportional hazards model for subset of participants with brain metastases.|||1.04|0.49|
72333552|NCT01559259|144191637|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.48||||0.003|TWO_SIDED|95.0|0.17|0.79|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.79|0.17|0.003
72333553|NCT01559259|144191637|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.23||||0.155|TWO_SIDED|95.0|-0.09|0.54|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.54|-0.09|0.155
72333554|NCT01559259|144191637|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.17||||0.135|TWO_SIDED|95.0|-0.05|0.39|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.39|-0.05|0.135
72424019|NCT03635489|144359094|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.3|||<|0.0001|TWO_SIDED|95.0|0.17|0.53|||Regression, Cox|||||0.53|0.17|<.0001
72424020|NCT03635489|144359094|SUPERIORITY|Unstratified Analysis|Hazard Ratio (HR)|0.34|||<|0.0001|TWO_SIDED|95.0|0.2|0.58|||Regression, Cox|||||0.58|0.20|<.0001
72424021|NCT03635489|144359095|SUPERIORITY|Unstratified analysis|Hazard Ratio (HR)|0.6|||||TWO_SIDED|95.0|0.3|1.21||||||||1.21|0.30|
72333555|NCT01559259|144191637|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.1||||0.35|TWO_SIDED|95.0|-0.11|0.32|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.32|-0.11|0.350
72333556|NCT01559259|144191637|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.25||||0.024|TWO_SIDED|95.0|0.03|0.47|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.47|0.03|0.024
72333557|NCT01559259|144191637|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.33|||<|0.001|TWO_SIDED|95.0|0.9|1.77|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.77|0.90|<0.001
72333558|NCT01559259|144191637|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.26|||<|0.001|TWO_SIDED|95.0|0.83|1.7|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.70|0.83|<0.001
72333559|NCT01559259|144191637|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.35||||0.001|TWO_SIDED|95.0|0.91|1.78|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.78|0.91|0.001
72333560|NCT01559259|144191637|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.87|||<|0.001|TWO_SIDED|95.0|0.43|1.3|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.30|0.43|<0.001
72424022|NCT01036022|144359166|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-75.0||||0.4788|TWO_SIDED|95.0|-284.8|134.9|||Mixed Models Analysis|||Placebo versus GSK1399686 10 mg for ACTH 1||134.9|-284.8|0.4788
72424023|NCT01036022|144359166|SUPERIORITY_OR_OTHER||Mean Difference (Net)|124.1||||0.2309|TWO_SIDED|95.0|-80.6|328.9|||Mixed Models Analysis|||Placebo versus GSK1399686 30 mg for ACTH 1||328.9|-80.6|0.2309
72424024|NCT01036022|144359166|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-185.1||||0.0758|TWO_SIDED|95.0|-389.8|19.7|||Mixed Models Analysis|||Placebo versus GSK1399686 100 mg for ACTH 1||19.7|-389.8|0.0758
72333561|NCT01559259|144191637|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.47||||0.003|TWO_SIDED|95.0|0.16|0.77|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.77|0.16|0.003
72333562|NCT01559259|144191637|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.4||||0.01|TWO_SIDED|95.0|0.1|0.7|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.70|0.10|0.010
72333563|NCT01559259|144191637|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.48||||0.002|TWO_SIDED|95.0|0.18|0.79|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.79|0.18|0.002
72333564|NCT01559259|144191637|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.12|||<|0.001|TWO_SIDED|95.0|1.66|2.58|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||2.58|1.66|<0.001
72333565|NCT01559259|144191637|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.96|||<|0.001|TWO_SIDED|95.0|1.5|2.42|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||2.42|1.50|<0.001
72333566|NCT01559259|144191637|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.14|||<|0.001|TWO_SIDED|95.0|1.67|2.6|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||2.60|1.67|<0.001
72333567|NCT01559259|144191637|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.74|||<|0.001|TWO_SIDED|95.0|1.28|2.2|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||2.20|1.28|<0.001
72424025|NCT01036022|144359166|SUPERIORITY_OR_OTHER||Median Difference (Net)|130.4||||0.2084|TWO_SIDED|95.0|-74.4|335.1|||Mixed Models Analysis|||Placebo versus GSK1399686 300 mg for ACTH 1||335.1|-74.4|0.2084
72424026|NCT01036022|144359166|SUPERIORITY_OR_OTHER||Mean Difference (Net)|132.6||||0.1684|TWO_SIDED|95.0|-57.4|322.6|||Mixed Models Analysis|||Placebo versus Asacol for ACTH 1||322.6|-57.4|0.1684
72424027|NCT01036022|144359166|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-90.4||||0.5122|TWO_SIDED|95.0|-364.7|184.0|||Mixed Models Analysis|||Placebo versus GSK1399686 10 mg for ACTH 2||184.0|-364.7|0.5122
72424028|NCT01036022|144359166|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-75.5||||0.5417|TWO_SIDED|95.0|-321.7|170.7|||Mixed Models Analysis|||Placebo versus GSK1399686 30 mg for ACTH 2||170.7|-321.7|0.5417
72424029|NCT01036022|144359166|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-54.4||||0.6511|TWO_SIDED|95.0|-294.2|185.3|||Mixed Models Analysis|||Placebo versus GSK1399686 100 mg for ACTH 2||185.3|-294.2|0.6511
72424030|NCT01036022|144359166|SUPERIORITY_OR_OTHER||Mean Difference (Net)|64.7||||0.6117|TWO_SIDED|95.0|-189.1|318.5|||Mixed Models Analysis|||Placebo versus GSK1399686 300 mg for ACTH 2||318.5|-189.1|0.6117
72424031|NCT01036022|144359166|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-99.7||||0.3882|TWO_SIDED|95.0|-329.3|129.9|||Mixed Models Analysis|||Placebo versus Asacol for ACTH 2||129.9|-329.3|0.3882
72424032|NCT01036022|144359166|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-125.5||||0.4781|TWO_SIDED|95.0|-477.5|226.5|||Mixed Models Analysis|||Placebo versus GSK1399686 10 mg for ACTH effect||226.5|-477.5|0.4781
72424033|NCT01036022|144359166|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-277.9||||0.0834|TWO_SIDED|95.0|-593.7|37.9|||Mixed Models Analysis|||Placebo versus GSK1399686 30 mg for ACTH effect||37.9|-593.7|0.0834
72424034|NCT01036022|144359166|SUPERIORITY_OR_OTHER||Mean Difference (Net)|121.7||||0.4313|TWO_SIDED|95.0|-185.8|429.3|||Mixed Models Analysis|||Placebo versus GSK1399686 100 mg for ACTH effect||429.3|-185.8|0.4313
72424035|NCT01036022|144359166|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-73.5||||0.6528|TWO_SIDED|95.0|-399.1|252.0|||Mixed Models Analysis|||Placebo versus GSK1399686 300 mg for ACTH effect||252.0|-399.1|0.6528
72424036|NCT01036022|144359166|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-248.5||||0.0966|TWO_SIDED|95.0|-542.9|46.0|||Mixed Models Analysis|||Placebo versus Asacol for ACTH effect||46.0|-542.9|0.0966
72424037|NCT01036022|144359166|SUPERIORITY_OR_OTHER||Mean Difference (Net)|32.2||||0.7704|TWO_SIDED|95.0|-187.6|252.0|||Mixed Models Analysis|||Placebo versus GSK1399686 10 mg for ACTH morning||252.0|-187.6|0.7704
72424038|NCT01036022|144359166|SUPERIORITY_OR_OTHER||Mean Difference (Net)|165.3||||0.0988|TWO_SIDED|95.0|-32.0|362.5|||Mixed Models Analysis|||Placebo versus GSK1399686 30 mg for ACTH morning||362.5|-32.0|0.0988
72424039|NCT01036022|144359166|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-153.4||||0.1153|TWO_SIDED|95.0|-345.5|38.7|||Mixed Models Analysis|||Placebo versus GSK1399686 100 mg for ACTH morning||38.7|-345.5|0.1153
72424040|NCT01036022|144359166|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.7||||0.9636|TWO_SIDED|95.0|-198.7|208.0|||Mixed Models Analysis|||Placebo versus GSK1399686 300 mg for ACTH morning||208.0|-198.7|0.9636
72424041|NCT01036022|144359166|SUPERIORITY_OR_OTHER||Mean Difference (Net)|119.8||||0.1972|TWO_SIDED|95.0|-64.1|303.8|||Mixed Models Analysis|||Placebo versus Asacol for ACTH morning||303.8|-64.1|0.1972
72424042|NCT01036022|144359166|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-207.6||||0.0495|TWO_SIDED|95.0|-414.6|-0.5|||Mixed Models Analysis|||Asacol versus GSK1399686 10 mg for ACTH 1||-0.5|-414.6|0.0495
72424043|NCT01036022|144359166|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-8.5||||0.9333|TWO_SIDED|95.0|-210.4|193.4|||Mixed Models Analysis|||Asacol versus GSK1399686 30 mg for ACTH 1||193.4|-210.4|0.9333
72424044|NCT01036022|144359166|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-317.7||||0.0025|TWO_SIDED|95.0|-519.6|-115.8|||Mixed Models Analysis|||Asacol versus GSK1399686 100 mg for ACTH 1||-115.8|-519.6|0.0025
72424045|NCT01036022|144359166|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.2||||0.9823|TWO_SIDED|95.0|-204.1|199.6|||Mixed Models Analysis|||Asacol versus GSK1399686 300 mg for ACTH 1||199.6|-204.1|0.9823
72424046|NCT01036022|144359166|SUPERIORITY_OR_OTHER||Mean Difference (Net)|9.3||||0.946|TWO_SIDED|95.0|-265.0|283.7|||Mixed Models Analysis|||Asacol versus GSK1399686 10 mg for ACTH 2||283.7|-265.0|0.9460
72424047|NCT01036022|144359166|SUPERIORITY_OR_OTHER||Mean Difference (Net)|24.2||||0.8445|TWO_SIDED|95.0|-222.0|270.4|||Mixed Models Analysis|||Asacol versus GSK1399686 30 mg for ACTH 2||270.4|-222.0|0.8445
72424048|NCT01036022|144359166|SUPERIORITY_OR_OTHER||Mean Difference (Net)|45.3||||0.7069|TWO_SIDED|95.0|-194.5|285.0|||Mixed Models Analysis|||Asacol versus GSK1399686 100 mg for ACTH 2||285.0|-194.5|0.7069
72424049|NCT01036022|144359166|SUPERIORITY_OR_OTHER||Mean Difference (Net)|164.4||||0.1998|TWO_SIDED|95.0|-89.4|418.2|||Mixed Models Analysis|||Asacol versus GSK1399686 300 mg for ACTH 2||418.2|-89.4|0.1998
72424050|NCT01036022|144359166|SUPERIORITY_OR_OTHER||Mean Difference (Net)|123.0||||0.4871|TWO_SIDED|95.0|-229.0|474.9|||Mixed Models Analysis|||Asacol versus GSK1399686 10 mg for ACTH effect||474.9|-229.0|0.4871
72424051|NCT01036022|144359166|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-29.4||||0.8527|TWO_SIDED|95.0|-345.2|286.4|||Mixed Models Analysis|||Asacol versus GSK1399686 30 mg for ACTH effect||286.4|-345.2|0.8527
72424052|NCT01036022|144359166|SUPERIORITY_OR_OTHER||Mean Difference (Net)|370.2||||0.0192|TWO_SIDED|95.0|62.6|677.8|||Mixed Models Analysis|||Asacol versus GSK1399686 100 mg for ACTH effect||677.8|62.6|0.0192
72424053|NCT01036022|144359166|SUPERIORITY_OR_OTHER||Mean Difference (Net)|174.9||||0.2865|TWO_SIDED|95.0|-150.6|500.5|||Mixed Models Analysis|||Asacol versus GSK1399686 300 mg for ACTH effect||500.5|-150.6|0.2865
72424054|NCT01036022|144359166|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-87.6||||0.4279|TWO_SIDED|95.0|-307.5|132.2|||Mixed Models Analysis|||Asacol versus GSK1399686 10 mg for ACTH morning||132.2|-307.5|0.4279
72424055|NCT01036022|144359166|SUPERIORITY_OR_OTHER||Mean Difference (Net)|45.4||||0.6464|TWO_SIDED|95.0|-151.8|242.7|||Mixed Models Analysis|||Asacol versus GSK1399686 30 mg for ACTH morning||242.7|-151.8|0.6464
72424056|NCT01036022|144359166|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-273.3||||0.0061|TWO_SIDED|95.0|-465.4|-81.2|||Mixed Models Analysis|||Asacol versus GSK1399686 100 mg for ACTH morning||-81.2|-465.4|0.0061
72424057|NCT01036022|144359166|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-115.2||||0.2614|TWO_SIDED|95.0|-318.5|88.1|||Mixed Models Analysis|||Asacol versus GSK1399686 300 mg for ACTH morning||88.1|-318.5|0.2614
72424058|NCT01036022|144359168|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3||||0.7559|TWO_SIDED|95.0|-2.0|1.5||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Placebo versus GSK1399686 10 mg for Week 1 SCCAI score||1.5|-2.0|0.7559
72424059|NCT01036022|144359168|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.4||||0.1238|TWO_SIDED|95.0|-0.4|3.2||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Placebo versus GSK1399686 30 mg for Week 1 SCCAI score||3.2|-0.4|0.1238
72333568|NCT01559259|144191637|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.38||||0.022|TWO_SIDED|95.0|0.05|0.7|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.70|0.05|0.022
72333569|NCT01559259|144191637|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.22||||0.181|TWO_SIDED|95.0|-0.1|0.54|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.54|-0.10|0.181
72333570|NCT01559259|144191637|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.4||||0.016|TWO_SIDED|95.0|0.07|0.72|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.72|0.07|0.016
72333571|NCT01559259|144191637|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.43|||<|0.001|TWO_SIDED|95.0|1.98|2.88|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||2.88|1.98|<0.001
72333572|NCT01559259|144191637|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.17|||<|0.001|TWO_SIDED|95.0|1.72|2.62|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||2.62|1.72|<0.001
72333573|NCT01559259|144191637|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.46|||<|0.001|TWO_SIDED|95.0|2.01|2.91|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||2.91|2.01|<0.001
72333574|NCT01559259|144191637|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.13|||<|0.001|TWO_SIDED|95.0|1.68|2.58|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||2.58|1.68|<0.001
72333575|NCT01559259|144191637|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.3||||0.065|TWO_SIDED|95.0|-0.02|0.61|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.61|-0.02|0.065
72333576|NCT01559259|144191637|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.04||||0.817|TWO_SIDED|95.0|-0.28|0.35|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.35|-0.28|0.817
72333577|NCT01559259|144191637|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.33||||0.043|TWO_SIDED|95.0|0.01|0.64|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.64|0.01|0.043
72424060|NCT01036022|144359168|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.4||||0.6302|TWO_SIDED|95.0|-1.3|2.2||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Placebo versus GSK1399686 100 mg for Week 1 SCCAI score||2.2|-1.3|0.6302
72333578|NCT01559259|144191637|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.53|||<|0.001|TWO_SIDED|95.0|2.06|3.01|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||3.01|2.06|<0.001
72333579|NCT01559259|144191637|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.34|||<|0.001|TWO_SIDED|95.0|1.87|2.82|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||2.82|1.87|<0.001
72333580|NCT01559259|144191637|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.63|||<|0.001|TWO_SIDED|95.0|2.15|3.11|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||3.11|2.15|<0.001
72333581|NCT01559259|144191637|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.36|||<|0.001|TWO_SIDED|95.0|1.89|2.84|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||2.84|1.89|<0.001
72333582|NCT01559259|144191637|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.17||||0.312|TWO_SIDED|95.0|-0.16|0.51|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.51|-0.16|0.312
72333583|NCT01559259|144191637|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.02||||0.91|TWO_SIDED|95.0|-0.35|0.31|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.31|-0.35|0.910
72333584|NCT01559259|144191637|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.27||||0.113|TWO_SIDED|95.0|-0.06|0.6|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.60|-0.06|0.113
72333585|NCT01559259|144191637|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.48|||<|0.001|TWO_SIDED|95.0|1.98|2.97|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||2.97|1.98|<0.001
72333586|NCT01559259|144191637|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.25|||<|0.001|TWO_SIDED|95.0|1.76|2.75|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||2.75|1.76|<0.001
72333587|NCT01559259|144191637|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.51|||<|0.001|TWO_SIDED|95.0|2.02|3.01|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||3.01|2.02|<0.001
72424061|NCT01036022|144359168|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.0||||0.2777|TWO_SIDED|95.0|-0.8|2.8|||Repeated measures mixed model|||Placebo versus GSK1399686 300 mg for Week 1 SCCAI score||2.8|-0.8|0.2777
72424062|NCT01036022|144359168|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2||||0.8069|TWO_SIDED|95.0|-1.4|1.8||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Placebo versus Asacol for Week 1 SCCAI score||1.8|-1.4|0.8069
72424063|NCT01036022|144359168|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3||||0.7699|TWO_SIDED|95.0|-1.6|2.2||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Placebo versus GSK1399686 10 mg for Week 2 SCCAI score||2.2|-1.6|0.7699
72424064|NCT01036022|144359168|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.8||||0.3869|TWO_SIDED|95.0|-1.1|2.8||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Placebo versus GSK1399686 30 mg for Week 2 SCCAI score||2.8|-1.1|0.3869
72424065|NCT01036022|144359168|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4||||0.6695|TWO_SIDED|95.0|-2.4|1.5||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Placebo versus GSK1399686 100 mg for Week 2 SCCAI score||1.5|-2.4|0.6695
72424066|NCT01036022|144359168|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.7||||0.5152|TWO_SIDED|95.0|-1.4|2.7||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Placebo versus GSK1399686 300 mg for Week 2 SCCAI score||2.7|-1.4|0.5152
72424067|NCT01036022|144359168|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7||||0.4507|TWO_SIDED|95.0|-2.4|1.1||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Placebo versus Asacol for Week 2 SCCAI score||1.1|-2.4|0.4507
72424068|NCT01036022|144359168|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2||||0.8707|TWO_SIDED|95.0|-1.9|2.3||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Placebo versus GSK1399686 10 mg for Week 3 SCCAI score||2.3|-1.9|0.8707
72424069|NCT01036022|144359168|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.1||||0.2915|TWO_SIDED|95.0|-0.9|3.1||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Placebo versus GSK1399686 30 mg for Week 3 SCCAI score||3.1|-0.9|0.2915
72424070|NCT01036022|144359168|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4||||0.7251|TWO_SIDED|95.0|-2.4|1.7||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Placebo versus GSK1399686 100 mg for Week 3 SCCAI score||1.7|-2.4|0.7251
72424071|NCT01036022|144359168|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.8||||0.4556|TWO_SIDED|95.0|-1.3|2.9||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Placebo versus GSK1399686 300 mg for Week 3 SCCAI score||2.9|-1.3|0.4556
72424072|NCT01036022|144359168|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4||||0.662|TWO_SIDED|95.0|-2.3|1.4||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Placebo versus Asacol for Week 3 SCCAI score||1.4|-2.3|0.6620
72424073|NCT01036022|144359168|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.2||||0.2844|TWO_SIDED|95.0|-1.1|3.5||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Placebo versus GSK1399686 10 mg for Week 4 SCCAI score||3.5|-1.1|0.2844
72424074|NCT01036022|144359168|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.2||||0.2799|TWO_SIDED|95.0|-1.0|3.5||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Placebo versus GSK1399686 30 mg for Week 4 SCCAI score||3.5|-1.0|0.2799
72333588|NCT01559259|144191637|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.35|||<|0.001|TWO_SIDED|95.0|1.86|2.85|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||2.85|1.86|<0.001
72424075|NCT01036022|144359168|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3||||0.7655|TWO_SIDED|95.0|-1.9|2.6||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Placebo versus GSK1399686 100 mg for Week 4 SCCAI score||2.6|-1.9|0.7655
72424076|NCT01036022|144359168|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.2||||0.3332|TWO_SIDED|95.0|-1.2|3.5||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Placebo versus GSK1399686 300 mg for Week 4 SCCAI score||3.5|-1.2|0.3332
72424077|NCT01036022|144359168|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.4||||0.6985|TWO_SIDED|95.0|-1.6|2.4||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Placebo versus Asacol for Week 4 SCCAI score||2.4|-1.6|0.6985
72424078|NCT01036022|144359168|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.2||||0.3256|TWO_SIDED|95.0|-1.3|3.7||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Placebo versus GSK1399686 10 mg for Week 5 SCCAI score||3.7|-1.3|0.3256
72424079|NCT01036022|144359168|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.6||||0.65|TWO_SIDED|95.0|-1.9|3.0||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Placebo versus GSK1399686 30 mg for Week 5 SCCAI score||3.0|-1.9|0.6500
72424080|NCT01036022|144359168|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2||||0.8758|TWO_SIDED|95.0|-2.3|2.7||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Placebo versus GSK1399686 100 mg for Week 5 SCCAI score||2.7|-2.3|0.8758
72333589|NCT01559259|144191637|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.12||||0.482|TWO_SIDED|95.0|-0.22|0.47|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.47|-0.22|0.482
72333590|NCT01559259|144191637|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.1||||0.573|TWO_SIDED|95.0|-0.44|0.24|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.24|-0.44|0.573
72333591|NCT01559259|144191637|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.16||||0.368|TWO_SIDED|95.0|-0.19|0.5|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.50|-0.19|0.368
72333592|NCT01559259|144191637|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.4|||<|0.001|TWO_SIDED|95.0|1.88|2.91|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||2.91|1.88|<0.001
72424081|NCT01036022|144359168|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.4||||0.7298|TWO_SIDED|95.0|-2.1|3.0||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Placebo versus GSK1399686 300 mg for Week 5 SCCAI score||3.0|-2.1|0.7298
72424082|NCT01036022|144359168|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6||||0.5963|TWO_SIDED|95.0|-2.8|1.6||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Placebo versus Asacol for Week 5 SCCAI score||1.6|-2.8|0.5963
72424083|NCT01036022|144359168|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.6||||0.6498|TWO_SIDED|95.0|-2.0|3.1||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Placebo versus GSK1399686 10 mg for Week 6 SCCAI score||3.1|-2.0|0.6498
72424084|NCT01036022|144359168|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.5||||0.7061|TWO_SIDED|95.0|-2.0|3.0||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Placebo versus GSK1399686 30 mg for Week 6 SCCAI score||3.0|-2.0|0.7061
72424085|NCT01036022|144359168|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2||||0.8549|TWO_SIDED|95.0|-2.7|2.3||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Placebo versus GSK1399686 100 mg for Week 6 SCCAI score||2.3|-2.7|0.8549
72424086|NCT01036022|144359168|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.6||||0.6533|TWO_SIDED|95.0|-2.0|3.1||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Placebo versus GSK1399686 300 mg for Week 6 SCCAI score||3.1|-2.0|0.6533
72424087|NCT01036022|144359168|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9||||0.4378|TWO_SIDED|95.0|-3.1|1.4||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Placebo versus Asacol for Week 6 SCCAI score||1.4|-3.1|0.4378
72424088|NCT01036022|144359168|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5||||0.5917|TWO_SIDED|95.0|-2.2|1.3||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Asacol versus GSK1399686 10 mg for Week 1 SCCAI score||1.3|-2.2|0.5917
72424089|NCT01036022|144359168|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.2||||0.1764|TWO_SIDED|95.0|-0.5|2.9||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Asacol versus GSK1399686 30 mg for Week 1 SCCAI score||2.9|-0.5|0.1764
72424090|NCT01036022|144359168|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2||||0.7914|TWO_SIDED|95.0|-1.5|2.0||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Asacol versus GSK1399686 100 mg for Week 1 SCCAI score||2.0|-1.5|0.7914
72424091|NCT01036022|144359168|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.8||||0.3578|TWO_SIDED|95.0|-0.9|2.5||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Asacol versus GSK1399686 300 mg for Week 1 SCCAI score||2.5|-0.9|0.3578
72333593|NCT01559259|144191637|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.17|||<|0.001|TWO_SIDED|95.0|1.66|2.68|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||2.68|1.66|<0.001
72424092|NCT01036022|144359168|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.9||||0.3247|TWO_SIDED|95.0|-1.0|2.9||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Asacol versus GSK1399686 10 mg for Week 2 SCCAI score||2.9|-1.0|0.3247
72424093|NCT01036022|144359168|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.5||||0.1153|TWO_SIDED|95.0|-0.4|3.4||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Asacol versus GSK1399686 30 mg for Week 2 SCCAI score||3.4|-0.4|0.1153
72424094|NCT01036022|144359168|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2||||0.7995|TWO_SIDED|95.0|-1.7|2.2||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Asacol versus GSK1399686 100 mg for Week 2 SCCAI score||2.2|-1.7|0.7995
72424095|NCT01036022|144359168|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.3||||0.1786|TWO_SIDED|95.0|-0.6|3.3||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Asacol versus GSK1399686 300 mg for Week 2 SCCAI score||3.3|-0.6|0.1786
72333594|NCT01559259|144191637|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.44|||<|0.001|TWO_SIDED|95.0|1.93|2.96|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||2.96|1.93|<0.001
72424096|NCT01036022|144359168|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.6||||0.5824|TWO_SIDED|95.0|-1.5|2.7||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Asacol versus GSK1399686 10 mg for Week 3 SCCAI score||2.7|-1.5|0.5824
72424097|NCT01036022|144359168|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.5||||0.1392|TWO_SIDED|95.0|-0.5|3.5||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Asacol versus GSK1399686 30 mg for Week 3 SCCAI score||3.5|-0.5|0.1392
72424098|NCT01036022|144359168|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.9665|TWO_SIDED|95.0|-2.0|2.1||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Asacol versus GSK1399686 100 mg for Week 3 SCCAI score||2.1|-2.0|0.9665
72424099|NCT01036022|144359168|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.2||||0.2455|TWO_SIDED|95.0|-0.9|3.3||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Asacol versus GSK1399686 300 mg for Week 3 SCCAI score||3.3|-0.9|0.2455
72424100|NCT01036022|144359168|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.8||||0.4644|TWO_SIDED|95.0|-1.4|3.1||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Asacol versus GSK1399686 10 mg for Week 4 SCCAI score||3.1|-1.4|0.4644
72424101|NCT01036022|144359168|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.8||||0.4567|TWO_SIDED|95.0|-1.4|3.0||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Asacol versus GSK1399686 30 mg for Week 4 SCCAI score||3.0|-1.4|0.4567
72424102|NCT01036022|144359168|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.9594|TWO_SIDED|95.0|-2.3|2.2||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Asacol versus GSK1399686 100 mg for Week 4 SCCAI score||2.2|-2.3|0.9594
72424103|NCT01036022|144359168|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.8||||0.5122|TWO_SIDED|95.0|-1.5|3.0||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Asacol versus GSK1399686 300 mg for Week 4 SCCAI score||3.0|-1.5|0.5122
72424104|NCT01036022|144359168|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.8||||0.1493|TWO_SIDED|95.0|-0.7|4.3||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Asacol versus GSK1399686 10 mg for Week 5 SCCAI score||4.3|-0.7|0.1493
72424105|NCT01036022|144359168|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.1||||0.3478|TWO_SIDED|95.0|-1.3|3.6||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Asacol versus GSK1399686 30 mg for Week 5 SCCAI score||3.6|-1.3|0.3478
72424106|NCT01036022|144359168|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.8||||0.5238|TWO_SIDED|95.0|-1.7|3.2||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Asacol versus GSK1399686 100 mg for Week 5 SCCAI score||3.2|-1.7|0.5238
72424107|NCT01036022|144359168|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.0||||0.4091|TWO_SIDED|95.0|-1.4|3.5||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Asacol versus GSK1399686 300 mg for Week 5 SCCAI score||3.5|-1.4|0.4091
72424108|NCT01036022|144359168|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.5||||0.2604|TWO_SIDED|95.0|-1.1|4.0||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Asacol versus GSK1399686 10 mg for Week 6 SCCAI score||4.0|-1.1|0.2604
72424109|NCT01036022|144359168|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.3||||0.2809|TWO_SIDED|95.0|-1.1|3.8||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Asacol versus GSK1399686 30 mg for Week 6 SCCAI score||3.8|-1.1|0.2809
72424110|NCT01036022|144359168|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.6||||0.6038|TWO_SIDED|95.0|-1.8|3.1||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Asacol versus GSK1399686 100 mg for Week 6 SCCAI score||3.1|-1.8|0.6038
72424111|NCT01036022|144359168|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.4||||0.2511|TWO_SIDED|95.0|-1.1|3.9||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Asacol versus GSK1399686 300 mg for Week 6 SCCAI score||3.9|-1.1|0.2511
72424112|NCT01036022|144359171|SUPERIORITY_OR_OTHER||Ratio|0.75|||||TWO_SIDED|95.0|0.24|2.39||||||Placebo versus GSK1399686 10 mg for Week 1 fecal calprotectin levels||2.39|0.24|
72424113|NCT01036022|144359171|SUPERIORITY_OR_OTHER||Ratio|0.64|||||TWO_SIDED|95.0|0.21|1.92||||||Placebo versus GSK1399686 30 mg for Week 1 fecal calprotectin levels||1.92|0.21|
72424114|NCT01036022|144359171|SUPERIORITY_OR_OTHER||Ratio|0.8|||||TWO_SIDED|95.0|0.26|2.48||||||Placebo versus GSK1399686 100 mg for Week 1 fecal calprotectin levels||2.48|0.26|
72424115|NCT01036022|144359171|SUPERIORITY_OR_OTHER||Ratio|0.85|||||TWO_SIDED|95.0|0.27|2.68||||||Placebo versus GSK1399686 300 mg for Week 1 fecal calprotectin levels||2.68|0.27|
72333595|NCT01559259|144191637|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.23|||<|0.001|TWO_SIDED|95.0|1.72|2.74|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||2.74|1.72|<0.001
72424116|NCT01036022|144359171|SUPERIORITY_OR_OTHER||Ratio|0.64|||||TWO_SIDED|95.0|0.23|1.81||||||Placebo versus Asacol for Week 1 fecal calprotectin levels||1.81|0.23|
72424117|NCT01036022|144359171|SUPERIORITY_OR_OTHER||Ratio|0.85|||||TWO_SIDED|95.0|0.26|2.73||||||Placebo versus GSK1399686 10 mg for Week 2 fecal calprotectin levels||2.73|0.26|
72424118|NCT01036022|144359171|SUPERIORITY_OR_OTHER||Ratio|0.55|||||TWO_SIDED|95.0|0.18|1.68||||||Placebo versus GSK1399686 30 mg for Week 2 fecal calprotectin levels||1.68|0.18|
72424119|NCT01036022|144359171|SUPERIORITY_OR_OTHER||Ratio|0.67|||||TWO_SIDED|95.0|0.21|2.18||||||Placebo versus GSK1399686 100 mg for Week 2 fecal calprotectin levels||2.18|0.21|
72424120|NCT01036022|144359171|SUPERIORITY_OR_OTHER||Ratio|0.62|||||TWO_SIDED|95.0|0.19|2.03||||||Placebo versus GSK1399686 300 mg for Week 2 fecal calprotectin levels||2.03|0.19|
72424121|NCT01036022|144359171|SUPERIORITY_OR_OTHER||Ratio|0.64|||||TWO_SIDED|95.0|0.22|1.9||||||Placebo versus Asacol for Week 2 fecal calprotectin levels||1.90|0.22|
72424122|NCT01036022|144359171|SUPERIORITY_OR_OTHER||Ratio|1.07|||||TWO_SIDED|95.0|0.28|4.09||||||Placebo versus GSK1399686 10 mg for Week 3 fecal calprotectin levels||4.09|0.28|
72424123|NCT01036022|144359171|SUPERIORITY_OR_OTHER||Ratio|0.74|||||TWO_SIDED|95.0|0.23|2.43||||||Placebo versus GSK1399686 30 mg for Week 3 fecal calprotectin levels||2.43|0.23|
72424124|NCT01036022|144359171|SUPERIORITY_OR_OTHER||Ratio|0.62|||||TWO_SIDED|95.0|0.18|2.08||||||Placebo versus GSK1399686 100 mg for Week 3 fecal calprotectin levels||2.08|0.18|
72424125|NCT01036022|144359171|SUPERIORITY_OR_OTHER||Ratio|0.6|||||TWO_SIDED|95.0|0.17|2.08||||||Placebo versus GSK1399686 300 mg for Week 3 fecal calprotectin levels||2.08|0.17|
72424126|NCT01036022|144359171|SUPERIORITY_OR_OTHER||Ratio|0.44|||||TWO_SIDED|95.0|0.15|1.32||||||Placebo versus Asacol for Week 3 fecal calprotectin levels||1.32|0.15|
72424127|NCT01036022|144359171|SUPERIORITY_OR_OTHER||Ratio|1.29|||||TWO_SIDED|95.0|0.33|5.04||||||Placebo versus GSK1399686 10 mg for Week 4 fecal calprotectin levels||5.04|0.33|
72424128|NCT01036022|144359171|SUPERIORITY_OR_OTHER||Ratio|0.64|||||TWO_SIDED|95.0|0.2|2.02||||||Placebo versus GSK1399686 30 mg for Week 4 fecal calprotectin levels||2.02|0.20|
72424129|NCT01036022|144359171|SUPERIORITY_OR_OTHER||Ratio|0.96|||||TWO_SIDED|95.0|0.29|3.23||||||Placebo versus GSK1399686 100 mg for Week 4 fecal calprotectin levels||3.23|0.29|
72333596|NCT01559259|144191637|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.17||||0.352|TWO_SIDED|95.0|-0.19|0.53|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.53|-0.19|0.352
72333597|NCT01559259|144191637|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.05||||0.771|TWO_SIDED|95.0|-0.41|0.3|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.30|-0.41|0.771
72333598|NCT01559259|144191637|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.22||||0.235|TWO_SIDED|95.0|-0.14|0.58|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.58|-0.14|0.235
72333599|NCT01559259|144191637|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.32|||<|0.001|TWO_SIDED|95.0|1.79|2.86|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||2.86|1.79|<0.001
72333600|NCT01559259|144191637|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.05|||<|0.001|TWO_SIDED|95.0|1.52|2.58|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||2.58|1.52|<0.001
72424130|NCT01036022|144359171|SUPERIORITY_OR_OTHER||Ratio|1.36|||||TWO_SIDED|95.0|0.39|4.72||||||Placebo versus GSK1399686 300 mg for Week 4 fecal calprotectin levels||4.72|0.39|
72424131|NCT01036022|144359171|SUPERIORITY_OR_OTHER||Ratio|0.82|||||TWO_SIDED|95.0|0.28|2.42||||||Placebo versus Asacol for Week 4 fecal calprotectin levels||2.42|0.28|
72424132|NCT01036022|144359171|SUPERIORITY_OR_OTHER||Ratio|0.61|||||TWO_SIDED|95.0|0.14|2.66||||||Placebo versus GSK1399686 10 mg for Week 5 fecal calprotectin levels||2.66|0.14|
72424133|NCT01036022|144359171|SUPERIORITY_OR_OTHER||Ratio|1.25|||||TWO_SIDED|95.0|0.35|4.38||||||Placebo versus GSK1399686 30 mg for Week 5 fecal calprotectin levels||4.38|0.35|
72424134|NCT01036022|144359171|SUPERIORITY_OR_OTHER||Ratio|0.71|||||TWO_SIDED|95.0|0.2|2.47||||||Placebo versus GSK1399686 100 mg for Week 5 fecal calprotectin levels||2.47|0.20|
72333601|NCT01559259|144191637|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.37|||<|0.001|TWO_SIDED|95.0|1.83|2.9|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||2.90|1.83|<0.001
72333602|NCT01559259|144191637|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.2|||<|0.001|TWO_SIDED|95.0|1.66|2.73|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||2.73|1.66|<0.001
72333603|NCT01559259|144191637|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.13||||0.51|TWO_SIDED|95.0|-0.25|0.5|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.50|-0.25|0.510
72333604|NCT01559259|144191637|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.15||||0.442|TWO_SIDED|95.0|-0.52|0.23|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.23|-0.52|0.442
72333605|NCT01559259|144191637|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.17||||0.372|TWO_SIDED|95.0|-0.2|0.54|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.54|-0.20|0.372
72333606|NCT01559259|144191637|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.97|||<|0.001|TWO_SIDED|95.0|1.39|2.55|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||2.55|1.39|<0.001
72333607|NCT01559259|144191637|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.82|||<|0.001|TWO_SIDED|95.0|1.25|2.4|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||2.40|1.25|<0.001
72333608|NCT01559259|144191637|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.15|||<|0.001|TWO_SIDED|95.0|1.57|2.72|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||2.72|1.57|<0.001
72333609|NCT01559259|144191637|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.87|||<|0.001|TWO_SIDED|95.0|1.3|2.45|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||2.45|1.30|<0.001
72333610|NCT01559259|144191637|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.1||||0.639|TWO_SIDED|95.0|-0.31|0.5|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.50|-0.31|0.639
72333611|NCT01559259|144191637|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.05||||0.803|TWO_SIDED|95.0|-0.45|0.35|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.35|-0.45|0.803
72333612|NCT01559259|144191637|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.27||||0.184|TWO_SIDED|95.0|-0.13|0.67|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.67|-0.13|0.184
72333613|NCT01559259|144191637|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.67|||<|0.001|TWO_SIDED|95.0|1.07|2.26|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||2.26|1.07|<0.001
72333614|NCT01559259|144191637|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.58|||<|0.001|TWO_SIDED|95.0|0.99|2.17|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||2.17|0.99|<0.001
72333615|NCT01559259|144191637|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.84|||<|0.001|TWO_SIDED|95.0|1.25|2.43|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||2.43|1.25|<0.001
72333616|NCT01559259|144191637|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.69|||<|0.001|TWO_SIDED|95.0|1.1|2.28|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||2.28|1.10|<0.001
72333617|NCT01559259|144191637|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.02||||0.91|TWO_SIDED|95.0|-0.44|0.39|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.39|-0.44|0.910
72333618|NCT01559259|144191637|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.11||||0.607|TWO_SIDED|95.0|-0.52|0.3|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.30|-0.52|0.607
72424135|NCT01036022|144359171|SUPERIORITY_OR_OTHER||Ratio|0.41|||||TWO_SIDED|95.0|0.11|1.46||||||Placebo versus GSK1399686 300 mg for Week 5 fecal calprotectin levels||1.46|0.11|
72424136|NCT01036022|144359171|SUPERIORITY_OR_OTHER||Ratio|0.47|||||TWO_SIDED|95.0|0.15|1.48||||||Placebo versus Asacol for Week 5 fecal calprotectin levels||1.48|0.15|
72424137|NCT01036022|144359171|SUPERIORITY_OR_OTHER||Ratio|0.66|||||TWO_SIDED|95.0|0.13|3.39||||||Placebo versus GSK1399686 10 mg for Week 6 fecal calprotectin levels||3.39|0.13|
72424138|NCT01036022|144359171|SUPERIORITY_OR_OTHER||Ratio|0.44|||||TWO_SIDED|95.0|0.11|1.84||||||Placebo versus GSK1399686 30 mg for Week 6 fecal calprotectin levels||1.84|0.11|
72424139|NCT01036022|144359171|SUPERIORITY_OR_OTHER||Ratio|0.37|||||TWO_SIDED|95.0|0.09|1.48||||||Placebo versus GSK1399686 100 mg for Week 6 fecal calprotectin levels||1.48|0.09|
72424140|NCT01036022|144359171|SUPERIORITY_OR_OTHER||Ratio|0.76|||||TWO_SIDED|95.0|0.19|2.99||||||Placebo versus GSK1399686 300 mg for Week 6 fecal calprotectin levels||2.99|0.19|
72424141|NCT01036022|144359171|SUPERIORITY_OR_OTHER||Ratio|0.72|||||TWO_SIDED|95.0|0.21|2.49||||||Placebo versus Asacol for Week 6 fecal calprotectin levels||2.49|0.21|
72424142|NCT01036022|144359172|SUPERIORITY_OR_OTHER||Ratio|1.19|||||TWO_SIDED|95.0|0.42|3.38||||||Placebo versus GSK1399686 10 mg for Week 1 fecal lactoferrin levels||3.38|0.42|
72424143|NCT01036022|144359172|SUPERIORITY_OR_OTHER||Ratio|1.35|||||TWO_SIDED|95.0|0.5|3.65||||||Placebo versus GSK1399686 30 mg for Week 1 fecal lactoferrin levels||3.65|0.50|
72424144|NCT01036022|144359172|SUPERIORITY_OR_OTHER||Ratio|1.25|||||TWO_SIDED|95.0|0.45|3.47||||||Placebo versus GSK1399686 100 mg for Week 1 fecal lactoferrin levels||3.47|0.45|
72424145|NCT01036022|144359172|SUPERIORITY_OR_OTHER||Ratio|1.26|||||TWO_SIDED|95.0|0.44|3.59||||||Placebo versus GSK1399686 300 mg for Week 1 fecal lactoferrin levels||3.59|0.44|
72424146|NCT01036022|144359172|SUPERIORITY_OR_OTHER||Ratio|1.28|||||TWO_SIDED|95.0|0.5|3.28||||||Placebo versus Asacol for Week 1 fecal lactoferrin levels||3.28|0.50|
72333619|NCT01559259|144191637|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.15||||0.484|TWO_SIDED|95.0|-0.27|0.56|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.56|-0.27|0.484
72333620|NCT01559259|144191637|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.25|||<|0.001|TWO_SIDED|95.0|0.64|1.86|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.86|0.64|<0.001
72424147|NCT01036022|144359172|SUPERIORITY_OR_OTHER||Ratio|0.76|||||TWO_SIDED|95.0|0.26|2.19||||||Placebo versus GSK1399686 10 mg for Week 2 fecal lactoferrin levels||2.19|0.26|
72424148|NCT01036022|144359172|SUPERIORITY_OR_OTHER||Ratio|0.59|||||TWO_SIDED|95.0|0.22|1.63||||||Placebo versus GSK1399686 30 mg for Week 2 fecal lactoferrin levels||1.63|0.22|
72424149|NCT01036022|144359172|SUPERIORITY_OR_OTHER||Ratio|0.35|||||TWO_SIDED|95.0|0.12|1.0||||||Placebo versus GSK1399686 100 mg for Week 2 fecal lactoferrin levels||1.00|0.12|
72424150|NCT01036022|144359172|SUPERIORITY_OR_OTHER||Ratio|0.93|||||TWO_SIDED|95.0|0.31|2.77||||||Placebo versus GSK1399686 300 mg for Week 2 fecal lactoferrin levels||2.77|0.31|
72424151|NCT01036022|144359172|SUPERIORITY_OR_OTHER||Ratio|0.7|||||TWO_SIDED|95.0|0.26|1.87||||||Placebo versus Asacol for Week 2 fecal lactoferrin levels||1.87|0.26|
72424152|NCT01036022|144359172|SUPERIORITY_OR_OTHER||Ratio|0.53|||||TWO_SIDED|95.0|0.15|1.84||||||Placebo versus GSK1399686 10 mg for Week 3 fecal lactoferrin levels||1.84|0.15|
72424153|NCT01036022|144359172|SUPERIORITY_OR_OTHER||Ratio|0.96|||||TWO_SIDED|95.0|0.32|2.87||||||Placebo versus GSK1399686 30 mg for Week 3 fecal lactoferrin levels||2.87|0.32|
72424154|NCT01036022|144359172|SUPERIORITY_OR_OTHER||Ratio|0.52|||||TWO_SIDED|95.0|0.17|1.56||||||Placebo versus GSK1399686 100 mg for Week 3 fecal lactoferrin levels||1.56|0.17|
72424155|NCT01036022|144359172|SUPERIORITY_OR_OTHER||Ratio|1.42|||||TWO_SIDED|95.0|0.45|4.46||||||Placebo versus GSK1399686 300 mg for Week 3 fecal lactoferrin levels||4.46|0.45|
72424156|NCT01036022|144359172|SUPERIORITY_OR_OTHER||Ratio|0.37|||||TWO_SIDED|95.0|0.14|1.01||||||Placebo versus Asacol for Week 3 fecal lactoferrin levels||1.01|0.14|
72424157|NCT01036022|144359172|SUPERIORITY_OR_OTHER||Ratio|0.33|||||TWO_SIDED|95.0|0.1|1.15||||||Placebo versus GSK1399686 10 mg for Week 4 fecal lactoferrin levels||1.15|0.10|
72424158|NCT01036022|144359172|SUPERIORITY_OR_OTHER||Ratio|0.68|||||TWO_SIDED|95.0|0.23|2.03||||||Placebo versus GSK1399686 30 mg for Week 4 fecal lactoferrin levels||2.03|0.23|
72424159|NCT01036022|144359172|SUPERIORITY_OR_OTHER||Ratio|0.56|||||TWO_SIDED|95.0|0.19|1.68||||||Placebo versus GSK1399686 100 mg for Week 4 fecal lactoferrin levels||1.68|0.19|
72424160|NCT01036022|144359172|SUPERIORITY_OR_OTHER||Ratio|1.19|||||TWO_SIDED|95.0|0.38|3.7||||||Placebo versus GSK1399686 300 mg for Week 4 fecal lactoferrin levels||3.70|0.38|
72424161|NCT01036022|144359172|SUPERIORITY_OR_OTHER||Ratio|0.71|||||TWO_SIDED|95.0|0.26|1.89||||||Placebo versus Asacol for Week 4 fecal lactoferrin levels||1.89|0.26|
72424162|NCT01036022|144359172|SUPERIORITY_OR_OTHER||Ratio|1.05|||||TWO_SIDED|95.0|0.27|4.07||||||Placebo versus GSK1399686 10 mg for Week 5 fecal lactoferrin levels||4.07|0.27|
72424163|NCT01036022|144359172|SUPERIORITY_OR_OTHER||Ratio|1.48|||||TWO_SIDED|95.0|0.46|4.73||||||Placebo versus GSK1399686 30 mg for Week 5 fecal lactoferrin levels||4.73|0.46|
72424164|NCT01036022|144359172|SUPERIORITY_OR_OTHER||Ratio|0.33|||||TWO_SIDED|95.0|0.11|1.02||||||Placebo versus GSK1399686 100 mg for Week 5 fecal lactoferrin levels||1.02|0.11|
72424165|NCT01036022|144359172|SUPERIORITY_OR_OTHER||Ratio|1.16|||||TWO_SIDED|95.0|0.36|3.73||||||Placebo versus GSK1399686 300 mg for Week 5 fecal lactoferrin levels||3.73|0.36|
72424166|NCT01036022|144359172|SUPERIORITY_OR_OTHER||Ratio|0.82|||||TWO_SIDED|95.0|0.29|2.33||||||Placebo versus Asacol for Week 5 fecal lactoferrin levels||2.33|0.29|
72424167|NCT01036022|144359172|SUPERIORITY_OR_OTHER||Ratio|1.44|||||TWO_SIDED|95.0|0.31|6.59||||||Placebo versus GSK1399686 10 mg for Week 6 fecal lactoferrin levels||6.59|0.31|
72424168|NCT01036022|144359172|SUPERIORITY_OR_OTHER||Ratio|2.21|||||TWO_SIDED|95.0|0.54|9.04||||||Placebo versus GSK1399686 30 mg for Week 6 fecal lactoferrin levels||9.04|0.54|
72424169|NCT01036022|144359172|SUPERIORITY_OR_OTHER||Ratio|0.41|||||TWO_SIDED|95.0|0.11|1.48||||||Placebo versus GSK1399686 100 mg for Week 6 fecal lactoferrin levels||1.48|0.11|
72424170|NCT01036022|144359172|SUPERIORITY_OR_OTHER||Ratio|1.64|||||TWO_SIDED|95.0|0.46|5.91||||||Placebo versus GSK1399686 300 mg for Week 6 fecal lactoferrin levels||5.91|0.46|
72424171|NCT01036022|144359172|SUPERIORITY_OR_OTHER||Ratio|0.84|||||TWO_SIDED|95.0|0.27|2.62||||||Placebo versus Asacol for Week 6 fecal lactoferrin levels||2.62|0.27|
72424172|NCT00576732|144359177|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.9|STANDARD_ERROR_OF_MEAN|2.18|<|0.001|TWO_SIDED|95.0|-12.19|-3.52||Type I error is preserved by the step down procedure, no multiple comparison adjustment is needed. A priori threshold for statistical significance was 0.05.|ANCOVA|ANCOVA model included factors for treatment group, center (after pooling of small centers), baseline weight stratification, and baseline ABC-I value|Mean difference is change in Risperidone high dose arm minus change in placebo arm.|"A step-down testing procedure was employed with the risperidone high dose versus placebo comparison tested first. If this comparison was significant the risperidone low dose versus placebo comparison would be performed.~A clinically relevant difference in the change from baseline on the ABC Irritability subscale was assumed to be 6 with a standard deviation of 8. To achieve 80% power with Type I error rate of 5%, 93 subjects were required."||-3.52|-12.19|<0.001
72424173|NCT00576732|144359177|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.0|STANDARD_ERROR_OF_MEAN|2.17||0.164|TWO_SIDED|95.0|-7.36|1.27||Type I error is preserved by the step down procedure, no multiple comparison adjustment is needed. A priori threshold for statistical significance was 0.05.|ANCOVA|ANCOVA model included factors for treatment group, center (after pooling of small centers), baseline weight stratification, and baseline ABC-I value|Mean difference is change in Risperidone low dose arm minus change in placebo arm.|||1.27|-7.36|0.164
72424174|NCT00576732|144359178|SUPERIORITY_OR_OTHER|||||||0.004||95.0||||P-value is not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test controlling for center (after pooling small centers) and baseline weight stratification.||||||0.004
72424175|NCT00576732|144359178|SUPERIORITY_OR_OTHER|||||||0.817||95.0||||P-value is not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test controlling for center (after pooling small centers) and baseline weight stratification.||||||0.817
72424176|NCT00576732|144359179|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|0.17|<|0.001|TWO_SIDED|95.0|-1.02|-0.33||P-value is not adjusted for multiple comparisons.|ANCOVA|ANCOVA model included factors for treatment group, center (after pooling of small centers), baseline weight stratification, and baseline CGI-S value.|Mean difference is change in Risperidone high dose arm minus change in placebo arm.|||-0.33|-1.02|<0.001
72424177|NCT00576732|144359179|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.17||0.769|TWO_SIDED|95.0|-0.39|0.29||P-value is not adjusted for multiple comparisons.|ANCOVA|ANCOVA model included factors for treatment group, center (after pooling of small centers), baseline weight stratification, and baseline CGI-S value|Mean difference is change in Risperidone low dose arm minus change in placebo arm.|||0.29|-0.39|0.769
72424178|NCT00576732|144359180|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test controlling for center (after pooling small centers) and baseline weight stratification.||||||<0.001
72424179|NCT00576732|144359180|SUPERIORITY_OR_OTHER|||||||0.985||95.0||||P-value is not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test controlling for center (after pooling small centers) and baseline weight stratification.||||||0.985
72424180|NCT05076149|144359187|NON_INFERIORITY|The non-inferiority margin represents a clinically acceptable loss of effectiveness that margin preserve at least 50% of the treatment effect of the active control (ELX/TEZ/IVA) compared to placebo, where the treatment effect is estimated by the lower bound of the 95% confidence interval (CI)|LS Mean difference|0.2|||<|0.0001|TWO_SIDED|95.0|-0.5|0.9|||Mixed Models Repeated Measures|||||0.9|-0.5|< 0.0001
72333621|NCT01559259|144191637|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.36|||<|0.001|TWO_SIDED|95.0|0.75|1.97|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.97|0.75|<0.001
72424181|NCT05076149|144359188|SUPERIORITY||LS Mean difference|-2.8|||=|0.0034|TWO_SIDED|95.0|-4.7|-0.9|||Mixed Models Repeated Measures|||||-0.9|-4.7|=0.0034
72424182|NCT05076149|144359189|OTHER||Odds Ratio (OR)|2.21|||<|0.0001|TWO_SIDED|95.0|1.55|3.16|||Generalized Estimated Equation Model|||||3.16|1.55|< 0.0001
72424183|NCT05076149|144359190|OTHER||Odds Ratio (OR)|2.87|||<|0.0001|TWO_SIDED|95.0|2.0|4.12|||Generalized Estimated Equation Model|||||4.12|2.00|< 0.0001
72424184|NCT05096208|144359191|EQUIVALENCE|Equivalence was established if the 2-sided 95% CI for the ratio of neutralizing GMTs for each pair of individual vaccine lots (RSVpreF Lot 1/RSVpreF Lot 2, RSVpreF Lot 1/RSVpreF Lot 3 and RSVpreF Lot 2/RSVpreF Lot 3) was within the interval (0.667, 1.5), for both antigens simultaneously.|Geometric Mean Ratio|1.0|||||TWO_SIDED|95.0|0.858|1.169|||||GMRs and 2-sided CIs were calculated by exponentiating the difference in least-square (LS) means and corresponding CIs based on analysis of logarithmically transformed assay results using a linear regression model.|RSV A||1.169|0.858|
72424185|NCT05096208|144359191|EQUIVALENCE|Equivalence was established if the 2-sided 95% CI for the ratio of neutralizing GMTs for each pair of individual vaccine lots (RSVpreF Lot 1/RSVpreF Lot 2, RSVpreF Lot 1/RSVpreF Lot 3 and RSVpreF Lot 2/RSVpreF Lot 3) was within the interval (0.667, 1.5), for both antigens simultaneously.|Geometric Mean Ratio|1.05|||||TWO_SIDED|95.0|0.9|1.215|||||GMRs and 2-sided CIs were calculated by exponentiating the difference in LS means and corresponding CIs based on analysis of logarithmically transformed assay results using a linear regression model.|RSV A||1.215|0.900|
72424186|NCT05096208|144359191|EQUIVALENCE|Equivalence was established if the 2-sided 95% CI for the ratio of neutralizing GMTs for each pair of individual vaccine lots (RSVpreF Lot 1/RSVpreF Lot 2, RSVpreF Lot 1/RSVpreF Lot 3 and RSVpreF Lot 2/RSVpreF Lot 3) was within the interval (0.667, 1.5), for both antigens simultaneously.|Geometric Mean Ratio|1.04|||||TWO_SIDED|95.0|0.886|1.232|||||GMRs and 2-sided CIs were calculated by exponentiating the difference in LS means and corresponding CIs based on analysis of logarithmically transformed assay results using a linear regression model.|RSV A||1.232|0.886|
72424187|NCT05096208|144359191|EQUIVALENCE|Equivalence was established if the 2-sided 95% CI for the ratio of neutralizing GMTs for each pair of individual vaccine lots (RSVpreF Lot 1/RSVpreF Lot 2, RSVpreF Lot 1/RSVpreF Lot 3 and RSVpreF Lot 2/RSVpreF Lot 3) was within the interval (0.667, 1.5), for both antigens simultaneously.|Geometric Mean Ratio|1.07|||||TWO_SIDED|95.0|0.905|1.261|||||GMRs and 2-sided CIs were calculated by exponentiating the difference in LS means and corresponding CIs based on analysis of logarithmically transformed assay results using a linear regression model.|RSV B||1.261|0.905|
72424188|NCT05096208|144359191|EQUIVALENCE|Equivalence was established if the 2-sided 95% CI for the ratio of neutralizing GMTs for each pair of individual vaccine lots (RSVpreF Lot 1/RSVpreF Lot 2, RSVpreF Lot 1/RSVpreF Lot 3 and RSVpreF Lot 2/RSVpreF Lot 3) was within the interval (0.667, 1.5), for both antigens simultaneously.|Geometric Mean Ratio|1.13|||||TWO_SIDED|95.0|0.953|1.336|||||GMRs and 2-sided CIs were calculated by exponentiating the difference in LS means and corresponding CIs based on analysis of logarithmically transformed assay results using a linear regression model.|RSV B||1.336|0.953|
72424189|NCT05096208|144359191|EQUIVALENCE|Equivalence was established if the 2-sided 95% CI for the ratio of neutralizing GMTs for each pair of individual vaccine lots (RSVpreF Lot 1/RSVpreF Lot 2, RSVpreF Lot 1/RSVpreF Lot 3 and RSVpreF Lot 2/RSVpreF Lot 3) was within the interval (0.667, 1.5), for both antigens simultaneously.|Geometric Mean Ratio|1.06|||||TWO_SIDED|95.0|0.884|1.262|||||GMRs and 2-sided CIs were calculated by exponentiating the difference in LS means and corresponding CIs based on analysis of logarithmically transformed assay results using a linear regression model.|RSV B||1.262|0.884|
72424190|NCT02087501|144359195|OTHER||Sample proportion|0.0|||||TWO_SIDED|95.0|0.0|11.6|||||The CI is calculated based on Clopper-Pearson method|||11.6|0|
72424191|NCT02087501|144359195|OTHER||Sample proportion|0.0|||||TWO_SIDED|95.0|0.0|11.6||||||||11.6|0|
72424192|NCT02087501|144359196|OTHER||Sample proportion|100.0|||||TWO_SIDED|95.0|88.4|100.0|||||CI is calculated based on Clopper-Pearson method|||100|88.4|
72424193|NCT02087501|144359197|OTHER||Sample proportion|80.0|||||TWO_SIDED|95.0|61.0|92.0||||||||92|61|
72424194|NCT00094328|144359200|OTHER|One sample t-test|Mean Difference (Final Values)|-1.62||||0.278|TWO_SIDED|95.0|-4.72|1.48|||t-test, 2 sided|||The primary efficacy parameter, change in growth rate (cm/year) after 12 months relative to the baseline growth rate was analysed using a one sample t-test. A 95% 2-sided confidence interval was calculated for the mean change in growth rate.||1.48|-4.72|0.278
72424195|NCT00094328|144359201|OTHER|One sample t-test|Median Difference (Final Values)|-0.07||||0.882|TWO_SIDED|95.0|-1.15|1.0|||t-test, 2 sided|||The primary efficacy parameter, change in growth rate (SD units) after 12 months relative to the baseline growth rate was analysed using a one sample t-test. A 95% 2-sided confidence interval was calculated for the mean change in growth rate.||1.00|-1.15|0.882
72424196|NCT01279343|144359244|SUPERIORITY||Mean Difference (Final Values)|-3.1||||0.03|TWO_SIDED|95.0|-5.9|-0.3|||t-test, 2 sided|||||-0.3|-5.9|0.03
72424197|NCT01279343|144359245|SUPERIORITY||Risk Ratio (RR)|0.99||||0.96|TWO_SIDED|95.0|0.8|1.23|||Chi-squared|||Comparison of vaginal delivery between groups.||1.23|.80|0.96
72424198|NCT01279343|144359245|SUPERIORITY||Risk Ratio (RR)|1.03||||0.9|TWO_SIDED|95.0|0.57|1.9|||Chi-squared|||Cesarean deliveries were compared between the groups.||1.90|0.57|0.90
72424199|NCT03245255|144359255|OTHER|Correlation analysis|Pearson Correlation Coefficient|-0.8|STANDARD_DEVIATION|0.1|||TWO_SIDED|||||||||||||
72424200|NCT04765735|144359257|SUPERIORITY||||||<|0.001||||||"It is hypothesized that the proportion of subjects with a reduction in overstimulation sensation during CL compared to OL period exceeds a performance goal of 50%.~H0: p ≤ 50% HA: p \> 50%"|Binomial Exact Test|||||||<0.001
72424201|NCT01022073|144359267|SUPERIORITY_OR_OTHER|||||||0.808|||||||t-test, 2 sided|This analysis is based on the completers. We are working on the imputation methods to account for the missing data and will revise results later.||||||0.808
72424202|NCT00971750|144359272|SUPERIORITY_OR_OTHER|||||||0.763||95.0|||||Chi-squared|||||||0.763
72424203|NCT00971750|144359274|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||||||<0.001
72424204|NCT01657266|144359275|SUPERIORITY_OR_OTHER|||||||1|||||||Pearson´s Chi-square test|||||||1.00
72424205|NCT02714868|144359332|OTHER|||||||0.05|||||||t-test, 2 sided|||For goal attainment, we calculated independent t-tests to compare GAS t-scores across groups at outcome. Lowest score is 0, highest score is 100. 100 is highest goal attainment.||||.05
72424206|NCT00981474|144359338|SUPERIORITY||Risk Ratio (RR)|0.96||||0.752|TWO_SIDED|95.0|0.82|1.121|||Chi-squared|||||1.121|.82|.752
72424207|NCT00981474|144359339|SUPERIORITY||Risk Ratio (RR)|0.55||||0.053|TWO_SIDED|95.0|0.32|0.93|||Chi-squared|||||.93|.32|.053
72424208|NCT00981474|144359340|SUPERIORITY||Risk Ratio (RR)|0.454||||0.149|TWO_SIDED|95.0|0.18|1.17|||Chi-squared|||||1.17|.18|.149
72424209|NCT00981474|144359341|SUPERIORITY||Hazard Ratio (HR)|0.581||||0.144|TWO_SIDED|95.0|0.3|1.13|||Chi-squared|||||1.13|.30|.144
72424210|NCT00981474|144359342|SUPERIORITY||Risk Ratio (RR)|0.724||||0.439|TWO_SIDED|95.0|0.37|1.41|||Chi-squared|||||1.41|.37|.439
72424211|NCT00981474|144359343|SUPERIORITY||Risk Ratio (RR)|0.872||||0.311|TWO_SIDED|95.0|0.69|1.11|||Chi-squared|||||1.11|.69|.311
72424212|NCT00981474|144359344|SUPERIORITY||Risk Ratio (RR)|0.247||||0.103|TWO_SIDED|95.0|0.005|1.18|||Fisher Exact|Fisher exact test used due to the small number of events.||||1.18|.005|.103
72424213|NCT00981474|144359345|SUPERIORITY||Risk Ratio (RR)|1.102||||0.608|TWO_SIDED|95.0|0.81|1.5|||Chi-squared|||||1.5|.81|.608
72424214|NCT00981474|144359346|SUPERIORITY||Risk Ratio (RR)|0.564||||0.541|TWO_SIDED|95.0|0.16|1.97|||Fisher Exact|Fisher exact test used due to the small number of events.||||1.97|.16|.541
72424215|NCT00981474|144359347|SUPERIORITY||Risk Ratio (RR)|0.247||||0.103|TWO_SIDED|95.0|0.05|1.18|||Fisher Exact|Fisher exact test used due to small number of events.||||1.18|.05|.103
72424216|NCT00981474|144359348|SUPERIORITY||Risk Ratio (RR)|0.409||||0.129|TWO_SIDED|95.0|0.15|1.14|||Chi-squared|||||1.14|.15|.129
72424217|NCT02583763|144359387|SUPERIORITY||||||>|0.05||||||Significance value stated as p\<0.05|t-test, 2 sided|||Paired sample T test were used to analyse normally distributed data.||||>0.05
72424218|NCT02583763|144359388|SUPERIORITY||||||>|0.05||||||Significance value was stated as p\<0.05|t-test, 2 sided|||||||>0.05
72424219|NCT02583763|144359389|SUPERIORITY|||||||0.003||||||Significance value was set to p\<0.05|t-test, 2 sided|||||||0.003
72424220|NCT05458024|144359395|SUPERIORITY||Beta coefficient|-0.14||||0.83|TWO_SIDED||||||Mixed Models Analysis|||||||0.83
72424221|NCT05458024|144359396|SUPERIORITY||Beta coefficient|-1.41||||0.21|TWO_SIDED|||||Analyses were adjusted for sex, baseline pain, and baseline vitamin D levels.|Mixed Models Analysis|||||||0.21
72333622|NCT01559259|144191637|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.38|||<|0.001|TWO_SIDED|95.0|0.77|1.99|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.99|0.77|<0.001
72333623|NCT01559259|144191637|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.5|||<|0.001|TWO_SIDED|95.0|0.89|2.1|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||2.10|0.89|<0.001
72333624|NCT01559259|144191637|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.25||||0.256|TWO_SIDED|95.0|-0.67|0.18|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.18|-0.67|0.256
72333625|NCT01559259|144191637|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.14||||0.526|TWO_SIDED|95.0|-0.56|0.29|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.29|-0.56|0.526
72333626|NCT01559259|144191637|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.11||||0.602|TWO_SIDED|95.0|-0.54|0.31|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.31|-0.54|0.602
72333627|NCT01559259|144191637|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.95||||0.002|TWO_SIDED|95.0|0.34|1.56|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.56|0.34|0.002
72333628|NCT01559259|144191637|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.98||||0.001|TWO_SIDED|95.0|0.38|1.59|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.59|0.38|0.001
72333629|NCT01559259|144191637|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.25|||<|0.001|TWO_SIDED|95.0|0.65|1.86|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.86|0.65|<0.001
72333630|NCT01559259|144191637|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.22|||<|0.001|TWO_SIDED|95.0|0.61|1.82|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.82|0.61|<0.001
72333631|NCT01559259|144191637|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.26||||0.224|TWO_SIDED|95.0|-0.69|0.16|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.16|-0.69|0.224
72333632|NCT01559259|144191637|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.23||||0.283|TWO_SIDED|95.0|-0.65|0.19|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.19|-0.65|0.283
72333633|NCT01559259|144191637|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.04||||0.86|TWO_SIDED|95.0|-0.39|0.46|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.46|-0.39|0.860
72333634|NCT01559259|144191637|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.63||||0.038|TWO_SIDED|95.0|0.03|1.22|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.22|0.03|0.038
72333635|NCT01559259|144191637|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.65||||0.031|TWO_SIDED|95.0|0.06|1.24|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.24|0.06|0.031
72333636|NCT01559259|144191637|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.03|||<|0.001|TWO_SIDED|95.0|0.43|1.62|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.62|0.43|<0.001
72333637|NCT01559259|144191637|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.95||||0.002|TWO_SIDED|95.0|0.36|1.54|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.54|0.36|0.002
72333638|NCT01559259|144191637|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.32||||0.129|TWO_SIDED|95.0|-0.74|0.09|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.09|-0.74|0.129
72333639|NCT01559259|144191637|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.3||||0.154|TWO_SIDED|95.0|-0.71|0.11|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.11|-0.71|0.154
72333640|NCT01559259|144191637|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.08||||0.714|TWO_SIDED|95.0|-0.34|0.49|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.49|-0.34|0.714
72333641|NCT01559259|144191637|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.37||||0.217|TWO_SIDED|95.0|-0.22|0.96|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.96|-0.22|0.217
72424222|NCT01395823|144359435|SUPERIORITY_OR_OTHER|||||||0.78|TWO_SIDED||||||Mixed Models Analysis|||||||0.78
72424223|NCT01483937|144359448|SUPERIORITY_OR_OTHER|||||||0.533||95.0|||||ANOVA|||||||.533
72424224|NCT01508013|144359457|SUPERIORITY_OR_OTHER|||||||0.633|||||||Mixed Models Analysis|||||||.633
72424225|NCT01508013|144359458|SUPERIORITY_OR_OTHER|||||||0.001|||||||Mixed Models Analysis|||||||.001
72424226|NCT01508013|144359459|SUPERIORITY_OR_OTHER|||||||0.018|||||||Mixed Models Analysis|||||||.018
72333642|NCT01559259|144191637|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.45||||0.136|TWO_SIDED|95.0|-0.14|1.03|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.03|-0.14|0.136
72333643|NCT01559259|144191637|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.78||||0.01|TWO_SIDED|95.0|0.19|1.37|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.37|0.19|0.010
72333644|NCT01559259|144191637|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.83||||0.006|TWO_SIDED|95.0|0.24|1.41|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.41|0.24|0.006
72333645|NCT01559259|144191637|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.45||||0.031|TWO_SIDED|95.0|-0.87|-0.04|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||-0.04|-0.87|0.031
72333646|NCT01559259|144191637|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.38||||0.07|TWO_SIDED|95.0|-0.79|0.03|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.03|-0.79|0.070
72333647|NCT01559259|144191637|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.05||||0.822|TWO_SIDED|95.0|-0.46|0.37|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.37|-0.46|0.822
72333648|NCT01559259|144191637|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.28||||0.327|TWO_SIDED|95.0|-0.28|0.83|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.83|-0.28|0.327
72333649|NCT01559259|144191637|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.34||||0.224|TWO_SIDED|95.0|-0.21|0.89|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.89|-0.21|0.224
72333650|NCT01559259|144191637|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.63||||0.025|TWO_SIDED|95.0|0.08|1.19|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.19|0.08|0.025
72333651|NCT01559259|144191637|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.7||||0.012|TWO_SIDED|95.0|0.15|1.25|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.25|0.15|0.012
72333652|NCT01559259|144191637|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.43||||0.03|TWO_SIDED|95.0|-0.81|-0.04|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||-0.04|-0.81|0.030
72333653|NCT01559259|144191637|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.36||||0.064|TWO_SIDED|95.0|-0.75|0.02|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.02|-0.75|0.064
72333654|NCT01559259|144191637|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.07||||0.721|TWO_SIDED|95.0|-0.46|0.32|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.32|-0.46|0.721
72333655|NCT01559259|144191638|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.22||||0.033|TWO_SIDED|95.0|0.02|0.42|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.42|0.02|0.033
72333656|NCT01559259|144191638|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.13||||0.224|TWO_SIDED|95.0|-0.08|0.33|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.33|-0.08|0.224
72333657|NCT01559259|144191638|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.23||||0.024|TWO_SIDED|95.0|0.03|0.44|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.44|0.03|0.024
72333658|NCT01559259|144191638|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.07||||0.501|TWO_SIDED|95.0|-0.13|0.27|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.27|-0.13|0.501
72333659|NCT01559259|144191638|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.15||||0.036|TWO_SIDED|95.0|0.01|0.29|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.29|0.01|0.036
72333660|NCT01559259|144191638|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.06||||0.435|TWO_SIDED|95.0|-0.08|0.2|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.20|-0.08|0.435
72333661|NCT01559259|144191638|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.16||||0.023|TWO_SIDED|95.0|0.02|0.31|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.31|0.02|0.023
72333662|NCT01559259|144191638|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.82|||<|0.001|TWO_SIDED|95.0|0.52|1.12|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.12|0.52|<0.001
72333663|NCT01559259|144191638|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.67|||<|0.001|TWO_SIDED|95.0|0.37|0.97|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.97|0.37|<0.001
72333664|NCT01559259|144191638|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.74|||<|0.001|TWO_SIDED|95.0|0.45|1.04|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.04|0.45|<0.001
72424227|NCT04534114|144359475|OTHER|Fesomersen groups were compared to the placebo group using two-sided log-rank tests. Due to the exploratory nature of these analyses, no multiplicity adjustment was done. Cause-specific hazard ratio and corresponding 2-sided 95% confidence intervals, comparing the hazards for the event-of-interest in each of the Fesomersen groups with the placebo group were estimated based on three separate cause-specific Cox proportional hazards models as exploratory analysis.|Cause specific Hazard ratio|0.94||||0.944|TWO_SIDED|95.0|0.19|4.68|||Log Rank|||||4.68|0.19|0.944
72333665|NCT01559259|144191638|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.45||||0.003|TWO_SIDED|95.0|0.16|0.75|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.75|0.16|0.003
72333666|NCT01559259|144191638|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.37|||<|0.001|TWO_SIDED|95.0|0.16|0.58|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.58|0.16|<0.001
72333667|NCT01559259|144191638|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.22||||0.039|TWO_SIDED|95.0|0.01|0.42|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.42|0.01|0.039
72333668|NCT01559259|144191638|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.29||||0.006|TWO_SIDED|95.0|0.08|0.5|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.50|0.08|0.006
72333669|NCT01559259|144191638|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.33|||<|0.001|TWO_SIDED|95.0|1.01|1.65|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.65|1.01|<0.001
72333670|NCT01559259|144191638|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.17|||<|0.001|TWO_SIDED|95.0|0.85|1.49|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.49|0.85|<0.001
72333671|NCT01559259|144191638|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.35|||<|0.001|TWO_SIDED|95.0|1.03|1.67|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.67|1.03|<0.001
72333672|NCT01559259|144191638|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.04|||<|0.001|TWO_SIDED|95.0|0.72|1.36|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.36|0.72|<0.001
72333673|NCT01559259|144191638|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.29||||0.011|TWO_SIDED|95.0|0.07|0.52|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.52|0.07|0.011
72333674|NCT01559259|144191638|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.13||||0.267|TWO_SIDED|95.0|-0.1|0.35|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.35|-0.10|0.267
72333675|NCT01559259|144191638|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.31||||0.007|TWO_SIDED|95.0|0.09|0.53|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.53|0.09|0.007
72424228|NCT04534114|144359475|OTHER|Fesomersen groups were compared to the placebo group using two-sided log-rank tests. Due to the exploratory nature of these analyses, no multiplicity adjustment was done. Cause-specific hazard ratio and corresponding 2-sided 95% confidence intervals, comparing the hazards for the event-of-interest in each of the Fesomersen groups with the placebo group were estimated based on three separate cause-specific Cox proportional hazards models as exploratory analysis.|Cause specific Hazard ratio|0.95||||0.953|TWO_SIDED|95.0|0.19|4.72|||Log Rank|||||4.72|0.19|0.953
72333676|NCT01559259|144191638|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.57|||<|0.001|TWO_SIDED|95.0|1.24|1.89|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.89|1.24|<0.001
72333677|NCT01559259|144191638|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.38|||<|0.001|TWO_SIDED|95.0|1.06|1.7|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.70|1.06|<0.001
72333678|NCT01559259|144191638|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.57|||<|0.001|TWO_SIDED|95.0|1.25|1.9|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.90|1.25|<0.001
72333679|NCT01559259|144191638|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.35|||<|0.001|TWO_SIDED|95.0|1.02|1.67|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.67|1.02|<0.001
72333680|NCT01559259|144191638|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.22||||0.056|TWO_SIDED|95.0|-0.01|0.45|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.45|-0.01|0.056
72333681|NCT01559259|144191638|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.04||||0.759|TWO_SIDED|95.0|-0.19|0.26|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.26|-0.19|0.759
72333682|NCT01559259|144191638|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.23||||0.051|TWO_SIDED|95.0|0.0|0.45|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.45|-0.00|0.051
72333683|NCT01559259|144191638|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.64|||<|0.001|TWO_SIDED|95.0|1.3|1.98|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.98|1.30|<0.001
72333684|NCT01559259|144191638|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.52|||<|0.001|TWO_SIDED|95.0|1.18|1.85|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.85|1.18|<0.001
72333685|NCT01559259|144191638|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.71|||<|0.001|TWO_SIDED|95.0|1.37|2.05|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||2.05|1.37|<0.001
72333686|NCT01559259|144191638|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.52|||<|0.001|TWO_SIDED|95.0|1.19|1.86|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.86|1.19|<0.001
72424229|NCT04534114|144359475|OTHER|Fesomersen groups were compared to the placebo group using two-sided log-rank tests. Due to the exploratory nature of these analyses, no multiplicity adjustment was done. Cause-specific hazard ratio and corresponding 2-sided 95% confidence intervals, comparing the hazards for the event-of-interest in each of the Fesomersen groups with the placebo group were estimated based on three separate cause-specific Cox proportional hazards models as exploratory analysis.|Cause specific Hazard ratio|0.63||||0.605|TWO_SIDED|95.0|0.1|3.75|||Log Rank|||||3.75|0.10|0.605
72333687|NCT01559259|144191638|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.11||||0.342|TWO_SIDED|95.0|-0.12|0.35|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.35|-0.12|0.342
72333688|NCT01559259|144191638|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.01||||0.943|TWO_SIDED|95.0|-0.24|0.23|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.23|-0.24|0.943
72333689|NCT01559259|144191638|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.18||||0.126|TWO_SIDED|95.0|-0.05|0.42|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.42|-0.05|0.126
72333690|NCT01559259|144191638|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.63|||<|0.001|TWO_SIDED|95.0|1.27|1.98|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.98|1.27|<0.001
72333691|NCT01559259|144191638|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.5|||<|0.001|TWO_SIDED|95.0|1.15|1.86|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.86|1.15|<0.001
72333692|NCT01559259|144191638|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.64|||<|0.001|TWO_SIDED|95.0|1.29|2.0|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||2.00|1.29|<0.001
72333693|NCT01559259|144191638|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.53|||<|0.001|TWO_SIDED|95.0|1.18|1.89|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.89|1.18|<0.001
72333694|NCT01559259|144191638|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.1||||0.453|TWO_SIDED|95.0|-0.15|0.34|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.34|-0.15|0.453
72333695|NCT01559259|144191638|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.03||||0.816|TWO_SIDED|95.0|-0.28|0.22|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.22|-0.28|0.816
72333696|NCT01559259|144191638|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.11||||0.384|TWO_SIDED|95.0|-0.14|0.36|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.36|-0.14|0.384
72333697|NCT01559259|144191638|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.55|||<|0.001|TWO_SIDED|95.0|1.19|1.91|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.91|1.19|<0.001
72333698|NCT01559259|144191638|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.46|||<|0.001|TWO_SIDED|95.0|1.1|1.82|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.82|1.10|<0.001
72424230|NCT04534114|144359476|OTHER|Fesomersen groups were compared to the placebo group using two-sided log-rank tests. Due to the exploratory nature of these analyses, no multiplicity adjustment was done. Cause-specific hazard ratio and corresponding 2-sided 95% confidence intervals, comparing the hazards for the event-of-interest in each of the Fesomersen groups with the placebo group were estimated based on three separate cause-specific Cox proportional hazards models as exploratory analysis.|Cause specific Hazard ratio|1.45||||0.612|TWO_SIDED|95.0|0.34|6.08|||Log Rank|||||6.08|0.34|0.612
72333699|NCT01559259|144191638|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.61|||<|0.001|TWO_SIDED|95.0|1.25|1.97|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.97|1.25|<0.001
72333700|NCT01559259|144191638|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.46|||<|0.001|TWO_SIDED|95.0|1.1|1.82|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.82|1.10|<0.001
72333701|NCT01559259|144191638|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.09||||0.483|TWO_SIDED|95.0|-0.16|0.34|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.34|-0.16|0.483
72333702|NCT01559259|144191638|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.0||||0.991|TWO_SIDED|95.0|-0.25|0.25|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.25|-0.25|0.991
72424231|NCT04534114|144359476|OTHER|Fesomersen groups were compared to the placebo group using two-sided log-rank tests. Due to the exploratory nature of these analyses, no multiplicity adjustment was done. Cause-specific hazard ratio and corresponding 2-sided 95% confidence intervals, comparing the hazards for the event-of-interest in each of the Fesomersen groups with the placebo group were estimated based on three separate cause-specific Cox proportional hazards models as exploratory analysis.|Cause specific Hazard ratio|1.27||||0.757|TWO_SIDED|95.0|0.28|5.66|||Log Rank|||||5.66|0.28|0.757
72333703|NCT01559259|144191638|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.16||||0.228|TWO_SIDED|95.0|-0.1|0.41|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.41|-0.10|0.228
72333704|NCT01559259|144191638|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.48|||<|0.001|TWO_SIDED|95.0|1.1|1.85|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.85|1.10|<0.001
72333705|NCT01559259|144191638|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.32|||<|0.001|TWO_SIDED|95.0|0.94|1.69|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.69|0.94|<0.001
72333706|NCT01559259|144191638|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.53|||<|0.001|TWO_SIDED|95.0|1.15|1.9|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.90|1.15|<0.001
72333707|NCT01559259|144191638|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.4|||<|0.001|TWO_SIDED|95.0|1.03|1.78|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.78|1.03|<0.001
72424232|NCT04534114|144359476|OTHER|Fesomersen groups were compared to the placebo group using two-sided log-rank tests. Due to the exploratory nature of these analyses, no multiplicity adjustment was done. Cause-specific hazard ratio and corresponding 2-sided 95% confidence intervals, comparing the hazards for the event-of-interest in each of the Fesomersen groups with the placebo group were estimated based on three separate cause-specific Cox proportional hazards models as exploratory analysis.|Cause specific Hazard ratio|0.91||||0.909|TWO_SIDED|95.0|0.18|4.52|||Log Rank|||||4.52|0.18|0.909
72333708|NCT01559259|144191638|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.07||||0.587|TWO_SIDED|95.0|-0.19|0.33|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.33|-0.19|0.587
72424233|NCT03287414|144359483|SUPERIORITY||Least Squares Mean Difference|0.063|STANDARD_ERROR_OF_MEAN|0.1379||0.3248|TWO_SIDED|80.0|-0.115|0.241||1-sided p-values were obtained using MMRM Model.|MMRM|||||0.241|-0.115|0.3248
72424234|NCT03287414|144359484|OTHER|||||||0.868|||||||Log Rank|||||||0.868
72333709|NCT01559259|144191638|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.09||||0.517|TWO_SIDED|95.0|-0.35|0.17|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.17|-0.35|0.517
72333710|NCT01559259|144191638|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.12||||0.36|TWO_SIDED|95.0|-0.14|0.38|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.38|-0.14|0.360
72333711|NCT01559259|144191638|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.2|||<|0.001|TWO_SIDED|95.0|0.81|1.6|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.60|0.81|<0.001
72333712|NCT01559259|144191638|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.17|||<|0.001|TWO_SIDED|95.0|0.78|1.57|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.57|0.78|<0.001
72333713|NCT01559259|144191638|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.36|||<|0.001|TWO_SIDED|95.0|0.97|1.76|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.76|0.97|<0.001
72333714|NCT01559259|144191638|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.17|||<|0.001|TWO_SIDED|95.0|0.77|1.56|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.56|0.77|<0.001
72333715|NCT01559259|144191638|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.03||||0.811|TWO_SIDED|95.0|-0.24|0.31|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.31|-0.24|0.811
72333716|NCT01559259|144191638|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.0||||0.977|TWO_SIDED|95.0|-0.27|0.28|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.28|-0.27|0.977
72333717|NCT01559259|144191638|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.2||||0.164|TWO_SIDED|95.0|-0.08|0.47|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.47|-0.08|0.164
72333718|NCT01559259|144191638|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.03|||<|0.001|TWO_SIDED|95.0|0.63|1.43|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.43|0.63|<0.001
72424235|NCT03287414|144359486|OTHER||Hazard Ratio (HR)|2.6||||0.921|TWO_SIDED|80.0|1.1|6.3|||Log Rank|||PFS1||6.3|1.1|0.921
72333719|NCT01559259|144191638|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.0|||<|0.001|TWO_SIDED|95.0|0.6|1.4|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.40|0.60|<0.001
72333720|NCT01559259|144191638|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.15|||<|0.001|TWO_SIDED|95.0|0.75|1.56|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.56|0.75|<0.001
72333721|NCT01559259|144191638|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.06|||<|0.001|TWO_SIDED|95.0|0.66|1.46|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.46|0.66|<0.001
72333722|NCT01559259|144191638|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.03||||0.846|TWO_SIDED|95.0|-0.31|0.25|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.25|-0.31|0.846
72333723|NCT01559259|144191638|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.05||||0.702|TWO_SIDED|95.0|-0.33|0.23|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.23|-0.33|0.702
72333724|NCT01559259|144191638|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.1||||0.496|TWO_SIDED|95.0|-0.18|0.38|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.38|-0.18|0.496
72333725|NCT01559259|144191638|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.81|||<|0.001|TWO_SIDED|95.0|0.41|1.22|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.22|0.41|<0.001
72333726|NCT01559259|144191638|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.81|||<|0.001|TWO_SIDED|95.0|0.4|1.21|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.21|0.40|<0.001
72333727|NCT01559259|144191638|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.86|||<|0.001|TWO_SIDED|95.0|0.46|1.26|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.26|0.46|<0.001
72333728|NCT01559259|144191638|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.92|||<|0.001|TWO_SIDED|95.0|0.52|1.33|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.33|0.52|<0.001
72424236|NCT03287414|144359486|OTHER||Hazard Ratio (HR)|2.2||||0.863|TWO_SIDED|80.0|0.9|5.6|||Log Rank|||PFS2||5.6|0.9|0.863
72424237|NCT03287414|144359487|OTHER||Hazard Ratio (HR)|2.2||||0.863|TWO_SIDED|80.0|0.9|5.6|||Log Rank|||FVC||5.6|0.9|0.863
72424238|NCT03287414|144359487|OTHER||Hazard Ratio (HR)|0.9||||0.457|TWO_SIDED|80.0|0.4|2.0|||Log Rank|||DLCO||2.0|0.4|0.457
72424239|NCT03287414|144359487|OTHER||Hazard Ratio (HR)|0.3||||0.019|TWO_SIDED|80.0|0.1|0.6|||Log Rank|||6MWD||0.6|0.1|0.019
72333729|NCT01559259|144191638|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.11||||0.441|TWO_SIDED|95.0|-0.39|0.17|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.17|-0.39|0.441
72424240|NCT03287414|144359488|OTHER||Hazard Ratio (HR)|1.1||||0.611|TWO_SIDED|80.0|0.6|2.0|||Log Rank|||Composite Endpoint 1||2.0|0.6|0.611
72333730|NCT01559259|144191638|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.12||||0.408|TWO_SIDED|95.0|-0.4|0.16|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.16|-0.40|0.408
72333731|NCT01559259|144191638|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.06||||0.652|TWO_SIDED|95.0|-0.35|0.22|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.22|-0.35|0.652
72333732|NCT01559259|144191638|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.61||||0.003|TWO_SIDED|95.0|0.21|1.02|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.02|0.21|0.003
72333733|NCT01559259|144191638|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.55||||0.007|TWO_SIDED|95.0|0.15|0.95|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.95|0.15|0.007
72333734|NCT01559259|144191638|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.69|||<|0.001|TWO_SIDED|95.0|0.29|1.1|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.10|0.29|<0.001
72333735|NCT01559259|144191638|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.7|||<|0.001|TWO_SIDED|95.0|0.29|1.1|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.10|0.29|<0.001
72333736|NCT01559259|144191638|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.08||||0.567|TWO_SIDED|95.0|-0.36|0.2|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.20|-0.36|0.567
72333737|NCT01559259|144191638|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.14||||0.315|TWO_SIDED|95.0|-0.42|0.14|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.14|-0.42|0.315
72333738|NCT01559259|144191638|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.0||||0.997|TWO_SIDED|95.0|-0.28|0.28|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.28|-0.28|0.997
72333739|NCT01559259|144191638|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.38||||0.056|TWO_SIDED|95.0|-0.01|0.77|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.77|-0.01|0.056
72333740|NCT01559259|144191638|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.39||||0.047|TWO_SIDED|95.0|0.01|0.78|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.78|0.01|0.047
72333741|NCT01559259|144191638|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.56||||0.005|TWO_SIDED|95.0|0.17|0.95|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.95|0.17|0.005
72333742|NCT01559259|144191638|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.53||||0.007|TWO_SIDED|95.0|0.14|0.92|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.92|0.14|0.007
72333743|NCT01559259|144191638|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.15||||0.276|TWO_SIDED|95.0|-0.42|0.12|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.12|-0.42|0.276
72333744|NCT01559259|144191638|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.14||||0.318|TWO_SIDED|95.0|-0.41|0.13|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.13|-0.41|0.318
72333745|NCT01559259|144191638|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.03||||0.849|TWO_SIDED|95.0|-0.25|0.3|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.30|-0.25|0.849
72424241|NCT03287414|144359488|OTHER||Hazard Ratio (HR)|1.1||||0.549|TWO_SIDED|80.0|0.6|1.9|||Log Rank|||Composite Endpoint 2||1.9|0.6|0.549
72333746|NCT01559259|144191638|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.29||||0.138|TWO_SIDED|95.0|-0.09|0.66|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.66|-0.09|0.138
72333747|NCT01559259|144191638|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.31||||0.111|TWO_SIDED|95.0|-0.07|0.68|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.68|-0.07|0.111
72333748|NCT01559259|144191638|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.42||||0.031|TWO_SIDED|95.0|0.04|0.79|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.79|0.04|0.031
72333749|NCT01559259|144191638|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.49||||0.011|TWO_SIDED|95.0|0.11|0.87|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.87|0.11|0.011
72333750|NCT01559259|144191638|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.2||||0.135|TWO_SIDED|95.0|-0.47|0.06|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.06|-0.47|0.135
72424242|NCT03287414|144359489|SUPERIORITY||Least Squares of the Mean|-0.92|STANDARD_ERROR_OF_MEAN|1.3109||0.7576|TWO_SIDED|80.0|-2.615|0.774||1-sided p-values were obtained using MMRM Model.|MMRM|||||0.774|-2.615|0.7576
72333751|NCT01559259|144191638|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.18||||0.175|TWO_SIDED|95.0|-0.44|0.08|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.08|-0.44|0.175
72333752|NCT01559259|144191638|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.07||||0.59|TWO_SIDED|95.0|-0.34|0.19|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.19|-0.34|0.590
72333753|NCT01559259|144191638|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.15||||0.402|TWO_SIDED|95.0|-0.2|0.49|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.49|-0.20|0.402
72333754|NCT01559259|144191638|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.2||||0.261|TWO_SIDED|95.0|-0.15|0.54|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.54|-0.15|0.261
72333755|NCT01559259|144191638|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.26||||0.134|TWO_SIDED|95.0|-0.08|0.61|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.61|-0.08|0.134
72333756|NCT01559259|144191638|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.38||||0.031|TWO_SIDED|95.0|0.03|0.72|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.72|0.03|0.031
72333757|NCT01559259|144191638|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.23||||0.061|TWO_SIDED|95.0|-0.47|0.01|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.01|-0.47|0.061
72333758|NCT01559259|144191638|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.18||||0.138|TWO_SIDED|95.0|-0.42|0.06|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.06|-0.42|0.138
72333759|NCT01559259|144191638|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.11||||0.353|TWO_SIDED|95.0|-0.35|0.13|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.13|-0.35|0.353
72333760|NCT01559259|144191639|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.88||||0.006|TWO_SIDED|95.0|0.25|1.51|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.51|0.25|0.006
72333761|NCT01559259|144191639|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.69||||0.03|TWO_SIDED|95.0|0.07|1.31|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.31|0.07|0.030
72333762|NCT01559259|144191639|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.81||||0.012|TWO_SIDED|95.0|0.17|1.44|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.44|0.17|0.012
72333763|NCT01559259|144191639|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.38||||0.237|TWO_SIDED|95.0|-0.25|1.01|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.01|-0.25|0.237
72424243|NCT03287414|144359490|SUPERIORITY||Least Squares of the Mean|32.222|STANDARD_ERROR_OF_MEAN|61.8632||0.3018|TWO_SIDED|80.0|-47.572|112.015||1-sided p-values were obtained using MMRM Model.|MMRM|||||112.015|-47.572|0.3018
72333764|NCT01559259|144191639|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.5||||0.024|TWO_SIDED|95.0|0.07|0.93|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.93|0.07|0.024
72333765|NCT01559259|144191639|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.31||||0.15|TWO_SIDED|95.0|-0.11|0.73|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.73|-0.11|0.150
72333766|NCT01559259|144191639|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.43||||0.054|TWO_SIDED|95.0|-0.01|0.86|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.86|-0.01|0.054
72333767|NCT01559259|144191639|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.89|||<|0.001|TWO_SIDED|95.0|1.92|3.85|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||3.85|1.92|<0.001
72424244|NCT03287414|144359491|SUPERIORITY||Least Squares of the Mean|29.166|STANDARD_ERROR_OF_MEAN|60.0143||0.314|TWO_SIDED|80.0|-48.22|106.553||1-sided p-values were obtained using MMRM Model.|MMRM|||||106.553|-48.220|0.3140
72424245|NCT03287414|144359492|SUPERIORITY||Least Squares of the mean|1.77|STANDARD_ERROR_OF_MEAN|1.5422||0.1269|TWO_SIDED|80.0|-0.219|3.759||1-sided p-values were obtained using MMRM Model.|MMRM|||||3.759|-0.219|0.1269
72424246|NCT01316770|144359517|SUPERIORITY|The standard deviation (SD) of the change in salivary flow was assumed to be 0.0168 for the placebo and 0.0906 for the dexamethasone parotid. The within-subject correlation between two glands was assumed to be 0.15. A total of 16 patients would be required to have 80% power to detect a one-sided 40% increase in dexamethasone-irrigated parotid glands compared with the saline irrigated parotid glands with respect to change in salivary flow from Day 0 to Day 56.||||||0.236||||||No corrections were made for multiple comparisons because there was only one primary hypothesis.|one-sided Paired t-test|||The mixed models analysis included all time points but it failed to converge. Therefore, an alternative analysis was performed using a paired t-test. Because the Satterthwaite correction \[that was specified in the statistical analysis plan (SAP) for the mixed model\] is not available for the paired t-test, it was not performed on the paired t-test. The final analysis was based upon the raw non-transformed saliva flow rates, as these measures were appropriate for the model used.||||0.236
72424247|NCT01316770|144359518|SUPERIORITY|||||||0.662|||||||one-sided paired t-test|||The mixed models analysis (including all time points: study days 14, 28, 42, 56) failed to converge; thus, an alternative analysis, as stated in the Statistical Analysis Plan, was performed using the paired t-test. The Satterthwaite correction (Statistical Analysis Plan) is not available for the paired t-test and was not performed on the paired t-test. The final analysis was based upon the raw non-transformed saliva flow rates since this statistical model achieved the best fit to the data.||||0.662
72424248|NCT01316770|144359519|SUPERIORITY|||||||0.607|||||||one-sided paired t-test|||The mixed models analysis (including all time points: study days 14, 28, 42, 56) failed to converge; thus, an alternative analysis, as stated in the Statistical Analysis Plan, was performed using the paired t-test. The Satterthwaite correction (Statistical Analysis Plan) is not available for the paired t-test and was not performed on the paired t-test. The final analysis was based upon the raw non-transformed saliva flow rates since this statistical model achieved the best fit to the data.||||0.607
72424249|NCT01316770|144359520|SUPERIORITY|||||||0.586|||||||one-sided paired t-test|||The mixed models analysis (including all time points: study days 14, 28, 42, 56) failed to converge; thus, an alternative analysis, as stated in the Statistical Analysis Plan, was performed using the paired t-test. The Satterthwaite correction (Statistical Analysis Plan) is not available for the paired t-test and was not performed on the paired t-test. The final analysis was based upon the raw non-transformed saliva flow rates since this statistical model achieved the best fit to the data.||||0.586
72424250|NCT01316770|144359534|OTHER|||||||0.5|||||||McNemar|||"McNemar's test on the study Day 14 shift table. The null hypothesis assumes the probability of subjects shifting from yes at Screening to no at Study Day 14 are equal to the probability of subjects shifting from no at Screening to yes at Study Day 14.~Alternative hypothesis is that probability of subjects shifting from yes at Screening to no at Study Day 14 is not equal to the probability of subjects shifting from no at Screening to yes at Study Day 14."||||0.500
72424251|NCT01316770|144359534|OTHER|||||||1|||||||McNemar|||"McNemar's test on the study Day 28 shift table. The null hypothesis assumes the probability of subjects shifting from yes at Screening to no at Study Day 28 is equal to the probability of subjects shifting their answer from no at Screening to yes at Study Day 28.~Alternative hypothesis is that probability of subjects shifting from yes at Screening to no at Study Day 28 is not equal to the probability of subjects shifting their answer from no at Screening to yes at Study Day 28."||||1.000
72333768|NCT01559259|144191639|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.52|||<|0.001|TWO_SIDED|95.0|1.56|3.47|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||3.47|1.56|<0.001
72333769|NCT01559259|144191639|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.51|||<|0.001|TWO_SIDED|95.0|1.54|3.47|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||3.47|1.54|<0.001
72424252|NCT01316770|144359534|OTHER|||||||0.5|||||||McNemar|||"McNemar's test on the study Day 42 shift table. The null hypothesis assumes the probability of subjects shifting from yes at Screening to no at Study Day 42 are equal to the probability of subjects shifting from no at Screening to yes at Study Day 42.~Alternative hypothesis is that probability of subjects shifting from yes at Screening to no at Study Day 42 is not equal to the probability of subjects shifting from no at Screening to yes at Study Day 42."||||0.500
72424253|NCT01316770|144359534|OTHER|||||||1|||||||McNemar|||"McNemar's test on the study Day 56 shift table. The null hypothesis assumes the probability of subjects shifting from yes at Screening to no at Study Day 56 are equal to the probability of subjects shifting from no at Screening to yes at Study Day 56.~Alternative hypothesis is that probability of subjects shifting from yes at Screening to no at Study Day 56 is not equal to the probability of subjects shifting from no at Screening to yes at Study Day 56."||||1.000
72424254|NCT01316770|144359536|OTHER|||||||1|||||||McNemar|||"McNemar's test on the study Day 14 shift table. The null hypothesis assumes the probability of subjects shifting from yes at Screening to no at Study Day 14 are equal to the probability of subjects shifting from no at Screening to yes at Study Day 14.~Alternative hypothesis is that probability of subjects shifting from yes at Screening to no at Study Day 14 is not equal to the probability of subjects shifting from no at Screening to yes at Study Day 14."||||1.000
72424255|NCT01316770|144359536|OTHER|||||||1|||||||McNemar|||"McNemar's test on the study Day 28 shift table. The null hypothesis assumes the probability of subjects shifting from yes at Screening to no at Study Day 28 is equal to the probability of subjects shifting their answer from no at Screening to yes at Study Day 28.~Alternative hypothesis is that probability of subjects shifting from yes at Screening to no at Study Day 28 is not equal to the probability of subjects shifting their answer from no at Screening to yes at Study Day 28."||||1.000
72424256|NCT01316770|144359537|OTHER|||||||1|||||||McNemar|||"McNemar's test on the study Day 14 shift table. The null hypothesis assumes the probability of subjects shifting from yes at Screening to no at Study Day 14 are equal to the probability of subjects shifting from no at Screening to yes at Study Day 14.~Alternative hypothesis is that probability of subjects shifting from yes at Screening to no at Study Day 14 is not equal to the probability of subjects shifting from no at Screening to yes at Study Day 14."||||1.000
72424257|NCT01316770|144359537|OTHER|||||||1|||||||McNemar|||"McNemar's test on the study Day 28 shift table. The null hypothesis assumes the probability of subjects shifting from yes at Screening to no at Study Day 28 is equal to the probability of subjects shifting their answer from no at Screening to yes at Study Day 28.~Alternative hypothesis is that probability of subjects shifting from yes at Screening to no at Study Day 28 is not equal to the probability of subjects shifting their answer from no at Screening to yes at Study Day 28."||||1.000
72333770|NCT01559259|144191639|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.76|||<|0.001|TWO_SIDED|95.0|0.79|2.72|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||2.72|0.79|<0.001
72333771|NCT01559259|144191639|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.13|||<|0.001|TWO_SIDED|95.0|0.47|1.79|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.79|0.47|<0.001
72333772|NCT01559259|144191639|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.76||||0.021|TWO_SIDED|95.0|0.11|1.41|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.41|0.11|0.021
72333773|NCT01559259|144191639|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.75||||0.027|TWO_SIDED|95.0|0.09|1.41|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.41|0.09|0.027
72333774|NCT01559259|144191639|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|4.75|||<|0.001|TWO_SIDED|95.0|3.65|5.84|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||5.84|3.65|<0.001
72333775|NCT01559259|144191639|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|4.21|||<|0.001|TWO_SIDED|95.0|3.13|5.29|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||5.29|3.13|<0.001
72333776|NCT01559259|144191639|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|4.47|||<|0.001|TWO_SIDED|95.0|3.37|5.56|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||5.56|3.37|<0.001
72333777|NCT01559259|144191639|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|3.92|||<|0.001|TWO_SIDED|95.0|2.83|5.02|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||5.02|2.83|<0.001
72333778|NCT01559259|144191639|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.83||||0.031|TWO_SIDED|95.0|0.08|1.58|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.58|0.08|0.031
72333779|NCT01559259|144191639|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.29||||0.442|TWO_SIDED|95.0|-0.44|1.02|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.02|-0.44|0.442
72333780|NCT01559259|144191639|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.55||||0.152|TWO_SIDED|95.0|-0.2|1.3|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.30|-0.20|0.152
72333781|NCT01559259|144191639|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|5.62|||<|0.001|TWO_SIDED|95.0|4.52|6.72|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||6.72|4.52|<0.001
72424258|NCT01316770|144359537|OTHER|||||||1|||||||McNemar|||"McNemar's test on the study Day 42 shift table. The null hypothesis assumes the probability of subjects shifting from yes at Screening to no at Study Day 42 are equal to the probability of subjects shifting from no at Screening to yes at Study Day 42.~Alternative hypothesis is that probability of subjects shifting from yes at Screening to no at Study Day 42 is not equal to the probability of subjects shifting from no at Screening to yes at Study Day 42."||||1.000
72333782|NCT01559259|144191639|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|5.04|||<|0.001|TWO_SIDED|95.0|3.96|6.13|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||6.13|3.96|<0.001
72333783|NCT01559259|144191639|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|5.4|||<|0.001|TWO_SIDED|95.0|4.3|6.5|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||6.50|4.30|<0.001
72333784|NCT01559259|144191639|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|4.88|||<|0.001|TWO_SIDED|95.0|3.78|5.98|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||5.98|3.78|<0.001
72333785|NCT01559259|144191639|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.74||||0.055|TWO_SIDED|95.0|-0.01|1.49|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.49|-0.01|0.055
72333786|NCT01559259|144191639|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.16||||0.666|TWO_SIDED|95.0|-0.57|0.9|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.90|-0.57|0.666
72333787|NCT01559259|144191639|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.51||||0.181|TWO_SIDED|95.0|-0.24|1.27|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.27|-0.24|0.181
72333788|NCT01559259|144191639|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|5.86|||<|0.001|TWO_SIDED|95.0|4.71|7.01|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||7.01|4.71|<0.001
72333789|NCT01559259|144191639|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|5.43|||<|0.001|TWO_SIDED|95.0|4.29|6.57|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||6.57|4.29|<0.001
72333790|NCT01559259|144191639|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|5.79|||<|0.001|TWO_SIDED|95.0|4.64|6.94|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||6.94|4.64|<0.001
72333791|NCT01559259|144191639|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|5.34|||<|0.001|TWO_SIDED|95.0|4.19|6.5|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||6.50|4.19|<0.001
72333792|NCT01559259|144191639|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.52||||0.2|TWO_SIDED|95.0|-0.27|1.31|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.31|-0.27|0.200
72333793|NCT01559259|144191639|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.08||||0.831|TWO_SIDED|95.0|-0.69|0.85|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.85|-0.69|0.831
72333794|NCT01559259|144191639|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.45||||0.268|TWO_SIDED|95.0|-0.34|1.24|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.24|-0.34|0.268
72333795|NCT01559259|144191639|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|5.73|||<|0.001|TWO_SIDED|95.0|4.54|6.91|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||6.91|4.54|<0.001
72333796|NCT01559259|144191639|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|5.31|||<|0.001|TWO_SIDED|95.0|4.13|6.48|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||6.48|4.13|<0.001
72424259|NCT01316770|144359537|OTHER|||||||1|||||||McNemar|||"McNemar's test on the study Day 56 shift table. The null hypothesis assumes the probability of subjects shifting from yes at Screening to no at Study Day 56 are equal to the probability of subjects shifting from no at Screening to yes at Study Day 56.~Alternative hypothesis is that probability of subjects shifting from yes at Screening to no at Study Day 56 is not equal to the probability of subjects shifting from no at Screening to yes at Study Day 56."||||1.000
72333797|NCT01559259|144191639|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|5.6|||<|0.001|TWO_SIDED|95.0|4.41|6.78|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||6.78|4.41|<0.001
72333798|NCT01559259|144191639|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|5.35|||<|0.001|TWO_SIDED|95.0|4.17|6.54|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||6.54|4.17|<0.001
72333799|NCT01559259|144191639|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.37||||0.367|TWO_SIDED|95.0|-0.44|1.19|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.19|-0.44|0.367
72424260|NCT01316770|144359540|OTHER|||||||0.25|||||||McNemar|||"McNemar's test on the study Day 14 shift table. The null hypothesis assumes the probability of subjects shifting from yes at Screening to no at Study Day 14 are equal to the probability of subjects shifting from no at Screening to yes at Study Day 14.~Alternative hypothesis is that probability of subjects shifting from yes at Screening to no at Study Day 14 is not equal to the probability of subjects shifting from no at Screening to yes at Study Day 14."||||0.250
72424261|NCT01316770|144359540|OTHER|||||||1|||||||McNemar|||"McNemar's test on the study Day 28 shift table. The null hypothesis assumes the probability of subjects shifting from yes at Screening to no at Study Day 28 is equal to the probability of subjects shifting their answer from no at Screening to yes at Study Day 28.~Alternative hypothesis is that probability of subjects shifting from yes at Screening to no at Study Day 28 is not equal to the probability of subjects shifting their answer from no at Screening to yes at Study Day 28."||||1.000
72333800|NCT01559259|144191639|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.05||||0.908|TWO_SIDED|95.0|-0.84|0.75|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.75|-0.84|0.908
72333801|NCT01559259|144191639|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.25||||0.553|TWO_SIDED|95.0|-0.57|1.06|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.06|-0.57|0.553
72333802|NCT01559259|144191639|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|5.45|||<|0.001|TWO_SIDED|95.0|4.22|6.68|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||6.68|4.22|<0.001
72333803|NCT01559259|144191639|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|5.1|||<|0.001|TWO_SIDED|95.0|3.88|6.31|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||6.31|3.88|<0.001
72333804|NCT01559259|144191639|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|5.42|||<|0.001|TWO_SIDED|95.0|4.19|6.66|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||6.66|4.19|<0.001
72333805|NCT01559259|144191639|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|5.17|||<|0.001|TWO_SIDED|95.0|3.94|6.4|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||6.40|3.94|<0.001
72333806|NCT01559259|144191639|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.28||||0.518|TWO_SIDED|95.0|-0.57|1.12|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.12|-0.57|0.518
72333807|NCT01559259|144191639|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.07||||0.86|TWO_SIDED|95.0|-0.9|0.75|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.75|-0.90|0.860
72333808|NCT01559259|144191639|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.25||||0.556|TWO_SIDED|95.0|-0.59|1.1|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.10|-0.59|0.556
72333809|NCT01559259|144191639|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|5.44|||<|0.001|TWO_SIDED|95.0|4.17|6.71|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||6.71|4.17|<0.001
72333810|NCT01559259|144191639|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|4.93|||<|0.001|TWO_SIDED|95.0|3.68|6.19|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||6.19|3.68|<0.001
72333811|NCT01559259|144191639|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|5.27|||<|0.001|TWO_SIDED|95.0|4.0|6.54|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||6.54|4.00|<0.001
72424262|NCT01316770|144359540|OTHER|||||||1|||||||McNemar|||"McNemar's test on the study Day 42 shift table. The null hypothesis assumes the probability of subjects shifting from yes at Screening to no at Study Day 42 are equal to the probability of subjects shifting from no at Screening to yes at Study Day 42.~Alternative hypothesis is that probability of subjects shifting from yes at Screening to no at Study Day 42 is not equal to the probability of subjects shifting from no at Screening to yes at Study Day 42."||||1.000
72333812|NCT01559259|144191639|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|5.06|||<|0.001|TWO_SIDED|95.0|3.79|6.34|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||6.34|3.79|<0.001
72333813|NCT01559259|144191639|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.38||||0.392|TWO_SIDED|95.0|-0.49|1.25|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.25|-0.49|0.392
72333814|NCT01559259|144191639|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.13||||0.762|TWO_SIDED|95.0|-0.98|0.72|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.72|-0.98|0.762
72424263|NCT01316770|144359540|OTHER|||||||1|||||||McNemar|||"McNemar's test on the study Day 56 shift table. The null hypothesis assumes the probability of subjects shifting from yes at Screening to no at Study Day 56 are equal to the probability of subjects shifting from no at Screening to yes at Study Day 56.~Alternative hypothesis is that probability of subjects shifting from yes at Screening to no at Study Day 56 is not equal to the probability of subjects shifting from no at Screening to yes at Study Day 56."||||1.000
72424264|NCT01316770|144359541|OTHER|||||||1|||||||McNemar|||"McNemar's test on the study Day 14 shift table. The null hypothesis assumes the probability of subjects shifting from yes at Screening to no at Study Day 14 are equal to the probability of subjects shifting from no at Screening to yes at Study Day 14.~Alternative hypothesis is that probability of subjects shifting from yes at Screening to no at Study Day 14 is not equal to the probability of subjects shifting from no at Screening to yes at Study Day 14."||||1.000
72424265|NCT01316770|144359541|OTHER|||||||0.625|||||||McNemar|||"McNemar's test on the study Day 28 shift table. The null hypothesis assumes the probability of subjects shifting from yes at Screening to no at Study Day 28 is equal to the probability of subjects shifting their answer from no at Screening to yes at Study Day 28.~Alternative hypothesis is that probability of subjects shifting from yes at Screening to no at Study Day 28 is not equal to the probability of subjects shifting their answer from no at Screening to yes at Study Day 28."||||0.625
72424266|NCT01316770|144359541|OTHER|||||||0.5|||||||McNemar|||"McNemar's test on the study Day 42 shift table. The null hypothesis assumes the probability of subjects shifting from yes at Screening to no at Study Day 42 are equal to the probability of subjects shifting from no at Screening to yes at Study Day 42.~Alternative hypothesis is that probability of subjects shifting from yes at Screening to no at Study Day 42 is not equal to the probability of subjects shifting from no at Screening to yes at Study Day 42."||||0.5000
72424267|NCT01316770|144359541|OTHER|||||||1|||||||McNemar|||"McNemar's test on the study Day 56 shift table. The null hypothesis assumes the probability of subjects shifting from yes at Screening to no at Study Day 56 are equal to the probability of subjects shifting from no at Screening to yes at Study Day 56.~Alternative hypothesis is that probability of subjects shifting from yes at Screening to no at Study Day 56 is not equal to the probability of subjects shifting from no at Screening to yes at Study Day 56."||||1.000
72424268|NCT00069784|144359587|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.022||||0.6273|TWO_SIDED|95.0|0.937|1.114||For the analysis of the two coprimary efficacy outcomes, the overall Type 1 error was partitioned. The first coprimary outcome was tested at 4.4%, whereas the second coprimary outcome was tested at 1% (weighted Hochberg procedure).|Log Rank|Log-rank test stratified by double-blind treatment (omega-3 PUFA, placebo), baseline diabetes diagnosis and previous CV event.|Hazard ratio (glargine/standard care) estimated by Cox regression model with treatment (glargine, standard care) as factor, stratified by double-blind treatment (omega-3 PUFA, placebo), baseline diabetes diagnosis and previous CV event.|The total required number of first coprimary outcomes (2200) assumed that a hazard reduction of 14-16% was clinically significant and controlled the overall experiment-wise Type 1 error at 5% with a power of 80% for each outcome. The total number of participants needed to achieve this number of events within the planned enrollment and treatment periods was ultimately estimated to be 12 500 based on the CURE and HOPE study databases.||1.114|0.937|0.6273
72333815|NCT01559259|144191639|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.21||||0.638|TWO_SIDED|95.0|-0.66|1.08|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.08|-0.66|0.638
72333816|NCT01559259|144191639|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|4.55|||<|0.001|TWO_SIDED|95.0|3.2|5.9|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||5.90|3.20|<0.001
72333817|NCT01559259|144191639|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|4.45|||<|0.001|TWO_SIDED|95.0|3.11|5.78|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||5.78|3.11|<0.001
72333818|NCT01559259|144191639|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|4.91|||<|0.001|TWO_SIDED|95.0|3.56|6.26|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||6.26|3.56|<0.001
72333819|NCT01559259|144191639|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|4.39|||<|0.001|TWO_SIDED|95.0|3.04|5.74|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||5.74|3.04|<0.001
72333820|NCT01559259|144191639|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.16||||0.741|TWO_SIDED|95.0|-0.77|1.08|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.08|-0.77|0.741
72333821|NCT01559259|144191639|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.05||||0.907|TWO_SIDED|95.0|-0.85|0.95|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.95|-0.85|0.907
72333822|NCT01559259|144191639|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.51||||0.274|TWO_SIDED|95.0|-0.41|1.44|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.44|-0.41|0.274
72333823|NCT01559259|144191639|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|3.77|||<|0.001|TWO_SIDED|95.0|2.4|5.13|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||5.13|2.40|<0.001
72333824|NCT01559259|144191639|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|3.91|||<|0.001|TWO_SIDED|95.0|2.56|5.26|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||5.26|2.56|<0.001
72333825|NCT01559259|144191639|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|4.12|||<|0.001|TWO_SIDED|95.0|2.75|5.48|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||5.48|2.75|<0.001
72333826|NCT01559259|144191639|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|4.01|||<|0.001|TWO_SIDED|95.0|2.64|5.38|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||5.38|2.64|<0.001
72333827|NCT01559259|144191639|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.25||||0.607|TWO_SIDED|95.0|-1.18|0.69|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.69|-1.18|0.607
72333828|NCT01559259|144191639|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.1||||0.824|TWO_SIDED|95.0|-1.02|0.81|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.81|-1.02|0.824
72333829|NCT01559259|144191639|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.1||||0.827|TWO_SIDED|95.0|-0.83|1.04|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.04|-0.83|0.827
72333830|NCT01559259|144191639|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.98|||<|0.001|TWO_SIDED|95.0|1.58|4.39|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||4.39|1.58|<0.001
72333831|NCT01559259|144191639|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|3.27|||<|0.001|TWO_SIDED|95.0|1.88|4.65|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||4.65|1.88|<0.001
72333832|NCT01559259|144191639|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|3.12|||<|0.001|TWO_SIDED|95.0|1.71|4.52|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||4.52|1.71|<0.001
72333833|NCT01559259|144191639|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|3.57|||<|0.001|TWO_SIDED|95.0|2.16|4.98|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||4.98|2.16|<0.001
72333834|NCT01559259|144191639|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.59||||0.232|TWO_SIDED|95.0|-1.55|0.38|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.38|-1.55|0.232
72333835|NCT01559259|144191639|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.31||||0.522|TWO_SIDED|95.0|-1.24|0.63|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.63|-1.24|0.522
72333836|NCT01559259|144191639|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.45||||0.356|TWO_SIDED|95.0|-1.41|0.51|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.51|-1.41|0.356
72333837|NCT01559259|144191639|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.31||||0.001|TWO_SIDED|95.0|0.92|3.69|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||3.69|0.92|0.001
72424269|NCT00069784|144359588|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.038||||0.2692|TWO_SIDED|95.0|0.972|1.109||The second coprimary outcome was tested at 1% (see above additional information for the first coprimary outcome).|Log Rank|Log-rank test stratified by double-blind treatment (omega-3 PUFA, placebo), baseline diabetes diagnosis and previous CV event.|Hazard ratio (glargine/standard care) estimated by Cox regression model with treatment (glargine, standard care) as factor, stratified by double-blind treatment (omega-3 PUFA, placebo), baseline diabetes diagnosis and previous CV event.|See above additional details provided for the analysis of the first coprimary outcome.||1.109|0.972|0.2692
72424270|NCT00069784|144359589|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.983|||||TWO_SIDED|95.0|0.899|1.076|||||Hazard ratio (glargine/standard care) estimated by Cox regression model with treatment (glargine, standard care) as factor, with double-blind treatment (omega-3 PUFA, placebo), baseline diabetes diagnosis and previous CV event as covariates.|||1.076|0.899|
72424271|NCT00069784|144359590|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.97|||||TWO_SIDED|95.0|0.9|1.047|||||Hazard ratio (glargine/standard care) estimated by Cox regression model with treatment (glargine, standard care) as factor, with double-blind treatment (omega-3 PUFA, placebo), baseline diabetes diagnosis and previous CV event as covariates.|||1.047|0.900|
72424272|NCT00069784|144359591|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.72|||||TWO_SIDED|95.0|0.58|0.91|||||Odds ratio estimated using Cochran-Mantel-Haenszel (CMH) test method stratified by double-blind treatment (omega-3 PUFA or placebo) and previous cardiovascular event (yes or no).|||0.91|0.58|
72424273|NCT02294474|144359612|NON_INFERIORITY|Non-inferiority of SAR342434 over Humalog was demonstrated if upper bound of 2-sided 95% confidence interval(CI) of difference between SAR342434 \& Humalog was \<0.3%.Inverse non-inferiority of Humalog over SAR342434 was tested using hierarchical step-down testing procedure: if non-inferiority of SAR342434 over Humalog was demonstrated,then inverse non-inferiority of Humalog over SAR342434 was tested and demonstrated if lower bound of 2-sided 95% CI of difference between SAR342434 \& Humalog\>-0.3%.|Least Square (LS) Mean Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.072|||TWO_SIDED|95.0|-0.215|0.067|||||SAR342434 vs. Humalog|Analysis was performed using a MMRM approach with treatment groups, randomization strata, visit (Week 12, Week 26) and treatment-by-visit interaction as fixed categorical effects and baseline HbA1c value and baseline HbA1c value-by-visit interaction as continuous fixed covariates. An unstructured correlation matrix was used to model within-participant errors.||0.067|-0.215|
72424274|NCT05200936|144359621|SUPERIORITY|||||||0.7145||||||p-value is 1-sided|Mixed Models Analysis|||||||0.7145
72424275|NCT05200936|144359622|SUPERIORITY|||||||0.9613|||||||ANCOVA|||||||0.9613
72424276|NCT01672853|144359635|SUPERIORITY||Difference in LS Mean|-0.4|||||TWO_SIDED|95.0|-2.3|1.6||||||A mixed-effect model for repeated measures (MMRM) with an unstructured variance-covariance matrix for each participant was used to calculate a point estimate and a 95% confidence interval (CI) for the treatment difference between each treatment arm and placebo in least squares mean (LSMean) change from baseline in MQC at Week 96. With MMRM setting, all participants with available data from the 3 treatment groups with change in MQC at Week 48 and/or Week 96 contributed to the overall model.||1.6|-2.3|
72424277|NCT01672853|144359635|SUPERIORITY||Difference in LS Mean|1.0|||||TWO_SIDED|95.0|-1.0|3.0||||||A MMRM with an unstructured variancecovariance matrix for each participant was used to calculate a point estimate and a 95% CI for the treatment difference between each treatment arm and placebo in LSMean change from baseline in MQC at Week 96. With MMRM setting, all participants with available data from the 3 treatment groups with change in MQC at Week 48 and/or Week 96 contributed to the overall model.||3.0|-1.0|
72424278|NCT05473000|144359675|SUPERIORITY|||||||0.092|||||||t-test, 2 sided|||||||0.092
72424279|NCT00840996|144359696|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8|||<|0.001|TWO_SIDED|97.5|-1.23|-0.4||Test for superiority adjusted for 2 primary comparisons (2 outcomes)|Mixed Models Analysis|Llinear mixed-effects accounts for correlation exhibited by the repeated pain measurements on a given patient (spatial power correlation structure).||Postoperative analgesia was characterized using both pain scores and opioid consumption .We considered one of the groups to be better than the other on postoperative pain control with superiority on either outcome, in the presence of noninferiority on both outcomes. Thus, our primary hypothesis was assessed in a joint hypothesis testing framework .||-0.40|-1.23|<0.001
72424280|NCT00840996|144359697|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin: ratio of the geometric means not more than 1.3 greater (mean mg IV morphine equivalent not more than 30% greater ) than that of the other group|the ratio of the geometric means|0.8||||0.011|TWO_SIDED|95.0|0.65|1.21||Noninferiority hypotheses were evaluated against a one-sided significance criterion of 0.025 \[adjusting for testing in both directions: lidocaine vs. control and vs. control vs. lidocaine \]|Regression, Linear|Log-linear regression model was used; 0.1 mg added before taking the logarithm to accommodate the 2 patients who received 0 mg opioids.||Postoperative analgesia was characterized using both pain scores and opioid consumption .We considered one of the groups to be better than the other on postoperative pain control with superiority on either outcome, in the presence of noninferiority on both outcomes. Thus, our primary hypothesis was assessed in a joint hypothesis testing framework .||1.21|0.65|0.011
72424281|NCT00840996|144359698|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.91||||0.049|TWO_SIDED|95.0|0.84|1.0|||Regression, Logistic|||||1.00|0.84|0.049
72424282|NCT00840996|144359699|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.91||||0.31|TWO_SIDED|95.0|0.77|1.09|||Regression, Logistic|||Nausea - POD 2||1.09|0.77|0.31
72424283|NCT00840996|144359699|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.04||||0.44|TWO_SIDED|95.0|0.94|1.14|||Regression, Logistic|||Vomiting - POD 2||1.14|0.94|0.44
72424284|NCT00840996|144359700|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0||||0.15|TWO_SIDED|95.0|-2.4|0.4|||Regression, Linear|||||0.4|-2.4|0.15
72424285|NCT00840996|144359701|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.2||||0.002|TWO_SIDED|95.0|2.3|10.0|||Regression, Linear|||||10|2.3|0.002
72424286|NCT00840996|144359702|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.6||||0.04|TWO_SIDED|95.0|0.3|8.9|||Regression, Logistic|||||8.9|0.3|0.04
72424287|NCT04867785|144359713|SUPERIORITY||Least Squares (LS) Mean Difference|-0.38||||0.188|TWO_SIDED|95.0|-0.94|0.18|||Mixed Models Analysis|||||0.18|-0.94|0.188
72424288|NCT04867785|144359713|SUPERIORITY||LSMean Difference|-1.34|||<|0.001|TWO_SIDED|95.0|-1.84|-0.85|||Mixed Models Analysis|||||-0.85|-1.84|<0.001
72424289|NCT04867785|144359713|SUPERIORITY||LSMean Difference|-1.25|||<|0.001|TWO_SIDED|95.0|-1.85|-0.65|||Mixed Models Analysis|||||-0.65|-1.85|<0.001
72424290|NCT04867785|144359713|SUPERIORITY||LSMean Difference|-1.94|||<|0.001|TWO_SIDED|95.0|-2.44|-1.43|||Mixed Models Analysis|||||-1.43|-2.44|<0.001
72333838|NCT01559259|144191639|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.45|||<|0.001|TWO_SIDED|95.0|1.08|3.82|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||3.82|1.08|<0.001
72333839|NCT01559259|144191639|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.7|||<|0.001|TWO_SIDED|95.0|1.31|4.08|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||4.08|1.31|<0.001
72333840|NCT01559259|144191639|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.85|||<|0.001|TWO_SIDED|95.0|1.46|4.23|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||4.23|1.46|<0.001
72333841|NCT01559259|144191639|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.54||||0.264|TWO_SIDED|95.0|-1.49|0.41|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.41|-1.49|0.264
72333842|NCT01559259|144191639|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.4||||0.4|TWO_SIDED|95.0|-1.32|0.53|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.53|-1.32|0.400
72333843|NCT01559259|144191639|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.15||||0.758|TWO_SIDED|95.0|-1.1|0.8|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.80|-1.10|0.758
72333844|NCT01559259|144191639|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.62||||0.018|TWO_SIDED|95.0|0.27|2.97|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||2.97|0.27|0.018
72333845|NCT01559259|144191639|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.88||||0.006|TWO_SIDED|95.0|0.55|3.21|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||3.21|0.55|0.006
72424291|NCT04867785|144359713|SUPERIORITY||LSMean Difference|-1.83|||<|0.001|TWO_SIDED|95.0|-2.42|-1.24|||Mixed Models Analysis|||||-1.24|-2.42|<0.001
72424292|NCT04867785|144359713|SUPERIORITY||LSMean Difference|-1.96|||<|0.001|TWO_SIDED|95.0|-2.43|-1.5|||Mixed Models Analysis|||||-1.50|-2.43|<0.001
72333846|NCT01559259|144191639|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.29|||<|0.001|TWO_SIDED|95.0|0.94|3.63|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||3.63|0.94|<0.001
72333847|NCT01559259|144191639|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.4|||<|0.001|TWO_SIDED|95.0|1.05|3.75|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||3.75|1.05|<0.001
72333848|NCT01559259|144191639|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.78||||0.097|TWO_SIDED|95.0|-1.7|0.14|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.14|-1.70|0.097
72333849|NCT01559259|144191639|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.52||||0.254|TWO_SIDED|95.0|-1.42|0.38|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.38|-1.42|0.254
72333850|NCT01559259|144191639|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.11||||0.812|TWO_SIDED|95.0|-1.03|0.81|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.81|-1.03|0.812
72424293|NCT04867785|144359714|SUPERIORITY||LSMean Difference|0.98|||<|0.001|TWO_SIDED|95.0|0.52|1.43|||Mixed Models Analysis|||||1.43|0.52|<0.001
72424294|NCT04867785|144359714|SUPERIORITY||LSMean Difference|0.01||||0.935|TWO_SIDED|95.0|-0.34|0.37|||Mixed Models Analysis|||||0.37|-0.34|0.935
72424295|NCT04867785|144359714|SUPERIORITY||LSMean Difference|0.11||||0.668|TWO_SIDED|95.0|-0.39|0.6|||Mixed Models Analysis|||||0.60|-0.39|0.668
72424296|NCT04867785|144359714|SUPERIORITY||LSMean Difference|-0.58||||0.002|TWO_SIDED|95.0|-0.95|-0.21|||Mixed Models Analysis|||||-0.21|-0.95|0.002
72424297|NCT04867785|144359714|SUPERIORITY||LSMean Difference|-0.47||||0.056|TWO_SIDED|95.0|-0.95|0.01|||Mixed Models Analysis|||||0.01|-0.95|0.056
72424298|NCT04867785|144359714|SUPERIORITY||LSMean Difference|-0.61|||<|0.001|TWO_SIDED|95.0|-0.93|-0.29|||Mixed Models Analysis|||||-0.29|-0.93|<0.001
72424299|NCT04867785|144359715|SUPERIORITY||LSMean Difference|-0.24||||0.448|TWO_SIDED|95.0|-0.85|0.38|||Mixed Models Analysis|||||0.38|-0.85|0.448
72424300|NCT04867785|144359715|SUPERIORITY||LSMean Difference|-0.99||||0.001|TWO_SIDED|95.0|-1.6|-0.38|||Mixed Models Analysis|||||-0.38|-1.60|0.001
72424301|NCT04867785|144359715|SUPERIORITY||LSMean Difference|-1.2|||<|0.001|TWO_SIDED|95.0|-1.8|-0.59|||Mixed Models Analysis|||||-0.59|-1.80|<0.001
72333851|NCT01559259|144191639|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.32||||0.045|TWO_SIDED|95.0|0.03|2.61|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||2.61|0.03|0.045
72333852|NCT01559259|144191639|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.59||||0.015|TWO_SIDED|95.0|0.31|2.87|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||2.87|0.31|0.015
72333853|NCT01559259|144191639|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.73||||0.009|TWO_SIDED|95.0|0.43|3.02|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||3.02|0.43|0.009
72424302|NCT04867785|144359715|SUPERIORITY||LSMean Difference|-1.83|||<|0.001|TWO_SIDED|95.0|-2.41|-1.24|||Mixed Models Analysis|||||-1.24|-2.41|<0.001
72424303|NCT04867785|144359715|SUPERIORITY||LSMean Difference|-1.63|||<|0.001|TWO_SIDED|95.0|-2.27|-0.99|||Mixed Models Analysis|||||-0.99|-2.27|<0.001
72424304|NCT04867785|144359715|SUPERIORITY||LSMean Difference|-1.85|||<|0.001|TWO_SIDED|95.0|-2.39|-1.31|||Mixed Models Analysis|||||-1.31|-2.39|<0.001
72424305|NCT04867785|144359715|SUPERIORITY||LSMean Difference|0.82|||<|0.001|TWO_SIDED|95.0|0.35|1.29|||Mixed Models Analysis|||||1.29|0.35|<0.001
72424306|NCT04867785|144359715|SUPERIORITY||LSMean Difference|0.06||||0.796|TWO_SIDED|95.0|-0.41|0.53|||Mixed Models Analysis|||||0.53|-0.41|0.796
72333854|NCT01559259|144191639|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.08||||0.002|TWO_SIDED|95.0|0.78|3.37|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||3.37|0.78|0.002
72424307|NCT04867785|144359715|SUPERIORITY||LSMean Difference|-0.14||||0.548|TWO_SIDED|95.0|-0.61|0.32|||Mixed Models Analysis|||||0.32|-0.61|0.548
72424308|NCT04867785|144359715|SUPERIORITY||LSMean Difference|-0.77|||<|0.001|TWO_SIDED|95.0|-1.19|-0.36|||Mixed Models Analysis|||||-0.36|-1.19|<0.001
72424309|NCT04867785|144359715|SUPERIORITY||LSMean Difference|-0.57||||0.025|TWO_SIDED|95.0|-1.08|-0.07|||Mixed Models Analysis|||||-0.07|-1.08|0.025
72424310|NCT04867785|144359715|SUPERIORITY||LSMean Difference|-0.8|||<|0.001|TWO_SIDED|95.0|-1.16|-0.44|||Mixed Models Analysis|||||-0.44|-1.16|<0.001
72424311|NCT04867785|144359716|SUPERIORITY||Risk Difference (RD)|0.14||||0.121|TWO_SIDED|95.0|-0.04|0.32|||Regression, Logistic|||||0.32|-0.04|0.121
72424312|NCT04867785|144359716|SUPERIORITY||Risk Difference (RD)|0.36||||0.002|TWO_SIDED|95.0|0.13|0.59|||Regression, Logistic|||||0.59|0.13|0.002
72424313|NCT04867785|144359716|SUPERIORITY||Risk Difference (RD)|0.48|||<|0.001|TWO_SIDED|95.0|0.28|0.68|||Regression, Logistic|||||0.68|0.28|<0.001
72424314|NCT04867785|144359716|SUPERIORITY||Risk Difference (RD)|0.7|||<|0.001|TWO_SIDED|95.0|0.53|0.87|||Regression, Logistic|||||0.87|0.53|<0.001
72424315|NCT04867785|144359716|SUPERIORITY||Risk Difference (RD)|0.6|||<|0.001|TWO_SIDED|95.0|0.39|0.82|||Regression, Logistic|||||0.82|0.39|<0.001
72424316|NCT04867785|144359716|SUPERIORITY||Risk Difference (RD)|0.68|||<|0.001|TWO_SIDED|95.0|0.51|0.85|||Regression, Logistic|||||0.85|0.51|<0.001
72424317|NCT04867785|144359716|SUPERIORITY||Risk Difference (RD)|-0.21||||0.03|TWO_SIDED|95.0|-0.39|-0.02|||Regression, Logistic|||||-0.02|-0.39|0.030
72424318|NCT04867785|144359716|SUPERIORITY||Risk Difference (RD)|0.01||||0.938|TWO_SIDED|95.0|-0.22|0.24|||Regression, Logistic|||||0.24|-0.22|0.938
72424319|NCT04867785|144359716|SUPERIORITY||Risk Difference (RD)|0.13||||0.209|TWO_SIDED|95.0|-0.07|0.33|||Regression, Logistic|||||0.33|-0.07|0.209
72424320|NCT04867785|144359716|SUPERIORITY||Risk Difference (RD)|0.35|||<|0.001|TWO_SIDED|95.0|0.18|0.53|||Regression, Logistic|||||0.53|0.18|<0.001
72424321|NCT04867785|144359716|SUPERIORITY||Risk Difference (RD)|0.26||||0.024|TWO_SIDED|95.0|0.03|0.48|||Regression, Logistic|||||0.48|0.03|0.024
72424322|NCT04867785|144359716|SUPERIORITY||Risk Difference (RD)|0.33|||<|0.001|TWO_SIDED|95.0|0.16|0.51|||Regression, Logistic|||||0.51|0.16|<0.001
72424323|NCT04867785|144359717|SUPERIORITY||Risk Difference (RD)|0.14||||0.169|TWO_SIDED|95.0|-0.06|0.35|||Regression, Logistic|||||0.35|-0.06|0.169
72424324|NCT04867785|144359717|SUPERIORITY||Risk Difference (RD)|0.39||||0.001|TWO_SIDED|95.0|0.15|0.63|||Regression, Logistic|||||0.63|0.15|0.001
72424325|NCT04867785|144359717|SUPERIORITY||Risk Difference (RD)|0.37||||0.002|TWO_SIDED|95.0|0.14|0.6|||Regression, Logistic|||||0.60|0.14|0.002
72424326|NCT04867785|144359717|SUPERIORITY||Risk Difference (RD)|0.59|||<|0.001|TWO_SIDED|95.0|0.39|0.79|||Regression, Logistic|||||0.79|0.39|<0.001
72424327|NCT04867785|144359717|SUPERIORITY||Risk Difference (RD)|0.56|||<|0.001|TWO_SIDED|95.0|0.34|0.78|||Regression, Logistic|||||0.78|0.34|<0.001
72424328|NCT04867785|144359717|SUPERIORITY||Risk Difference (RD)|0.57|||<|0.001|TWO_SIDED|95.0|0.38|0.76|||Regression, Logistic|||||0.76|0.38|<0.001
72424329|NCT04867785|144359717|SUPERIORITY||Risk Difference (RD)|-0.23||||0.029|TWO_SIDED|95.0|-0.44|-0.02|||Regression, Logistic|||||-0.02|-0.44|0.029
72424330|NCT04867785|144359717|SUPERIORITY||Risk Difference (RD)|0.02||||0.898|TWO_SIDED|95.0|-0.22|0.25|||Regression, Logistic|||||0.25|-0.22|0.898
72424331|NCT04867785|144359717|SUPERIORITY||Risk Difference (RD)|0.0||||0.968|TWO_SIDED|95.0|-0.24|0.23|||Regression, Logistic|||||0.23|-0.24|0.968
72424332|NCT04867785|144359717|SUPERIORITY||Risk Difference (RD)|0.22||||0.033|TWO_SIDED|95.0|0.02|0.42|||Regression, Logistic|||||0.42|0.02|0.033
72424333|NCT04867785|144359717|SUPERIORITY||Risk Difference (RD)|0.19||||0.099|TWO_SIDED|95.0|-0.04|0.41|||Regression, Logistic|||||0.41|-0.04|0.099
72424334|NCT04867785|144359717|SUPERIORITY||Risk Difference (RD)|0.2||||0.044|TWO_SIDED|95.0|0.01|0.39|||Regression, Logistic|||||0.39|0.01|0.044
72424335|NCT04867785|144359718|SUPERIORITY||LSMean Difference|-2.12||||0.823|TWO_SIDED|95.0|-20.73|16.48|||Mixed Models Analysis|||||16.48|-20.73|0.823
72424336|NCT04867785|144359718|SUPERIORITY||LSMean Difference|-19.6||||0.165|TWO_SIDED|95.0|-47.29|8.1|||Mixed Models Analysis|||||8.10|-47.29|0.165
72424337|NCT04867785|144359718|SUPERIORITY||LSMean Difference|-33.3||||0.001|TWO_SIDED|95.0|-53.56|-13.04|||Mixed Models Analysis|||||-13.04|-53.56|0.001
72424338|NCT04867785|144359718|SUPERIORITY||LSMean Difference|-55.5|||<|0.001|TWO_SIDED|95.0|-69.77|-41.22|||Mixed Models Analysis|||||-41.22|-69.77|<0.001
72333855|NCT01559259|144191639|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.76||||0.094|TWO_SIDED|95.0|-1.64|0.13|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.13|-1.64|0.094
72333856|NCT01559259|144191639|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.49||||0.269|TWO_SIDED|95.0|-1.35|0.38|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.38|-1.35|0.269
72424339|NCT04867785|144359718|SUPERIORITY||LSMean Difference|-29.22||||0.015|TWO_SIDED|95.0|-52.84|-5.59|||Mixed Models Analysis|||||-5.59|-52.84|0.015
72424340|NCT04867785|144359718|SUPERIORITY||LSMean Difference|-54.61|||<|0.001|TWO_SIDED|95.0|-69.63|-39.59|||Mixed Models Analysis|||||-39.59|-69.63|<0.001
72424341|NCT04867785|144359718|SUPERIORITY||LSMean Difference|33.54|||<|0.001|TWO_SIDED|95.0|18.26|48.82|||Mixed Models Analysis|||||48.82|18.26|<0.001
72424342|NCT04867785|144359718|SUPERIORITY||LSMean Difference|16.07||||0.231|TWO_SIDED|95.0|-10.25|42.39|||Mixed Models Analysis|||||42.39|-10.25|0.231
72424343|NCT04867785|144359718|SUPERIORITY||LSMean Difference|2.37||||0.804|TWO_SIDED|95.0|-16.28|21.01|||Mixed Models Analysis|||||21.01|-16.28|0.804
72424344|NCT04867785|144359718|SUPERIORITY||LSMean Difference|-19.83|||<|0.001|TWO_SIDED|95.0|-31.01|-8.65|||Mixed Models Analysis|||||-8.65|-31.01|<0.001
72424345|NCT04867785|144359718|SUPERIORITY||LSMean Difference|6.45||||0.586|TWO_SIDED|95.0|-16.75|29.65|||Mixed Models Analysis|||||29.65|-16.75|0.586
72424346|NCT04867785|144359718|SUPERIORITY||LSMean Difference|-18.94||||0.002|TWO_SIDED|95.0|-30.93|-6.96|||Mixed Models Analysis|||||-6.96|-30.93|0.002
72424347|NCT04867785|144359719|SUPERIORITY||LSMean Difference|-0.25||||0.984|TWO_SIDED|95.0|-24.57|24.07|||Mixed Models Analysis|||||24.07|-24.57|0.984
72424348|NCT04867785|144359719|SUPERIORITY||LSMean Difference|-4.2||||0.804|TWO_SIDED|95.0|-37.44|29.03|||Mixed Models Analysis|||||29.03|-37.44|0.804
72424349|NCT04867785|144359719|SUPERIORITY||LSMean Difference|-21.47||||0.167|TWO_SIDED|95.0|-51.91|8.98|||Mixed Models Analysis|||||8.98|-51.91|0.167
72424350|NCT04867785|144359719|SUPERIORITY||LSMean Difference|-51.84|||<|0.001|TWO_SIDED|95.0|-76.09|-27.59|||Mixed Models Analysis|||||-27.59|-76.09|<0.001
72424351|NCT04867785|144359719|SUPERIORITY||LSMean Difference|-23.94||||0.168|TWO_SIDED|95.0|-57.94|10.06|||Mixed Models Analysis|||||10.06|-57.94|0.168
72424352|NCT04867785|144359719|SUPERIORITY||LSMean Difference|-50.58|||<|0.001|TWO_SIDED|95.0|-74.94|-26.22|||Mixed Models Analysis|||||-26.22|-74.94|<0.001
72424353|NCT04867785|144359719|SUPERIORITY||LSMean Difference|10.02||||0.362|TWO_SIDED|95.0|-11.55|31.6|||Mixed Models Analysis|||||31.60|-11.55|0.362
72424354|NCT04867785|144359719|SUPERIORITY||LSMean Difference|6.07||||0.696|TWO_SIDED|95.0|-24.34|36.48|||Mixed Models Analysis|||||36.48|-24.34|0.696
72424355|NCT04867785|144359719|SUPERIORITY||LSMean Difference|-11.19||||0.436|TWO_SIDED|95.0|-39.38|16.99|||Mixed Models Analysis|||||16.99|-39.38|0.436
72424356|NCT04867785|144359719|SUPERIORITY||LSMean Difference|-41.57|||<|0.001|TWO_SIDED|95.0|-62.89|-20.25|||Mixed Models Analysis|||||-20.25|-62.89|<0.001
72424357|NCT04867785|144359719|SUPERIORITY||LSMean Difference|-13.67||||0.418|TWO_SIDED|95.0|-46.75|19.42|||Mixed Models Analysis|||||19.42|-46.75|0.418
72424358|NCT04867785|144359719|SUPERIORITY||LSMean Difference|-40.31|||<|0.001|TWO_SIDED|95.0|-60.77|-19.85|||Mixed Models Analysis|||||-19.85|-60.77|<0.001
72424359|NCT04867785|144359720|SUPERIORITY||LSMean Difference|-0.49||||0.54|TWO_SIDED|95.0|-2.07|1.08|||Mixed Models Analysis|||||1.08|-2.07|0.540
72333857|NCT01559259|144191639|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.35||||0.437|TWO_SIDED|95.0|-1.23|0.53|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.53|-1.23|0.437
72333858|NCT01559259|144191639|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.74||||0.218|TWO_SIDED|95.0|-0.44|1.92|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.92|-0.44|0.218
72333859|NCT01559259|144191639|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.19||||0.046|TWO_SIDED|95.0|0.02|2.35|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||2.35|0.02|0.046
72333860|NCT01559259|144191639|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.31||||0.03|TWO_SIDED|95.0|0.13|2.49|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||2.49|0.13|0.030
72333861|NCT01559259|144191639|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.75||||0.004|TWO_SIDED|95.0|0.57|2.93|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||2.93|0.57|0.004
72333862|NCT01559259|144191639|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-1.01||||0.014|TWO_SIDED|95.0|-1.82|-0.2|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||-0.20|-1.82|0.014
72333863|NCT01559259|144191639|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.56||||0.16|TWO_SIDED|95.0|-1.35|0.22|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.22|-1.35|0.160
72333864|NCT01559259|144191639|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.44||||0.284|TWO_SIDED|95.0|-1.25|0.37|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.37|-1.25|0.284
72333865|NCT01559259|144191640|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.62||||0.014|TWO_SIDED|95.0|0.13|1.1|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.10|0.13|0.014
72333866|NCT01559259|144191640|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.46||||0.066|TWO_SIDED|95.0|-0.03|0.94|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.94|-0.03|0.066
72333867|NCT01559259|144191640|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.71||||0.004|TWO_SIDED|95.0|0.22|1.2|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.20|0.22|0.004
72333868|NCT01559259|144191640|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.3||||0.232|TWO_SIDED|95.0|-0.19|0.78|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.78|-0.19|0.232
72333869|NCT01559259|144191640|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.32||||0.067|TWO_SIDED|95.0|-0.02|0.66|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.66|-0.02|0.067
72333870|NCT01559259|144191640|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.16||||0.354|TWO_SIDED|95.0|-0.18|0.5|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.50|-0.18|0.354
72333871|NCT01559259|144191640|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.42||||0.017|TWO_SIDED|95.0|0.08|0.76|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.76|0.08|0.017
72333872|NCT01559259|144191640|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.15|||<|0.001|TWO_SIDED|95.0|1.45|2.86|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||2.86|1.45|<0.001
72333873|NCT01559259|144191640|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.93|||<|0.001|TWO_SIDED|95.0|1.23|2.64|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||2.64|1.23|<0.001
72333874|NCT01559259|144191640|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.09|||<|0.001|TWO_SIDED|95.0|1.39|2.8|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||2.80|1.39|<0.001
72333875|NCT01559259|144191640|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.32|||<|0.001|TWO_SIDED|95.0|0.61|2.02|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||2.02|0.61|<0.001
72333876|NCT01559259|144191640|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.83|||<|0.001|TWO_SIDED|95.0|0.34|1.33|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.33|0.34|<0.001
72333877|NCT01559259|144191640|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.62||||0.014|TWO_SIDED|95.0|0.12|1.11|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.11|0.12|0.014
72333878|NCT01559259|144191640|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.77||||0.002|TWO_SIDED|95.0|0.28|1.27|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.27|0.28|0.002
72333879|NCT01559259|144191640|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|3.45|||<|0.001|TWO_SIDED|95.0|2.69|4.22|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||4.22|2.69|<0.001
72333880|NCT01559259|144191640|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|3.13|||<|0.001|TWO_SIDED|95.0|2.36|3.89|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||3.89|2.36|<0.001
72333881|NCT01559259|144191640|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|3.49|||<|0.001|TWO_SIDED|95.0|2.72|4.26|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||4.26|2.72|<0.001
72333882|NCT01559259|144191640|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.78|||<|0.001|TWO_SIDED|95.0|2.02|3.54|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||3.54|2.02|<0.001
72333883|NCT01559259|144191640|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.67||||0.014|TWO_SIDED|95.0|0.14|1.21|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.21|0.14|0.014
72333884|NCT01559259|144191640|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.35||||0.202|TWO_SIDED|95.0|-0.19|0.88|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.88|-0.19|0.202
72333885|NCT01559259|144191640|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.71||||0.01|TWO_SIDED|95.0|0.17|1.24|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.24|0.17|0.010
72333886|NCT01559259|144191640|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|4.0|||<|0.001|TWO_SIDED|95.0|3.24|4.76|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||4.76|3.24|<0.001
72424360|NCT04867785|144359720|SUPERIORITY||LSMean Difference|-4.41|||<|0.001|TWO_SIDED|95.0|-6.69|-2.13|||Mixed Models Analysis|||||-2.13|-6.69|<0.001
72424361|NCT04867785|144359720|SUPERIORITY||LSMean Difference|-6.78|||<|0.001|TWO_SIDED|95.0|-9.47|-4.09|||Mixed Models Analysis|||||-4.09|-9.47|<0.001
72424362|NCT04867785|144359720|SUPERIORITY||LSMean Difference|-10.13|||<|0.001|TWO_SIDED|95.0|-12.24|-8.03|||Mixed Models Analysis|||||-8.03|-12.24|<0.001
72424363|NCT04867785|144359720|SUPERIORITY||LSMean Difference|-12.06|||<|0.001|TWO_SIDED|95.0|-15.06|-9.06|||Mixed Models Analysis|||||-9.06|-15.06|<0.001
72424364|NCT04867785|144359720|SUPERIORITY||LSMean Difference|-10.99|||<|0.001|TWO_SIDED|95.0|-13.24|-8.73|||Mixed Models Analysis|||||-8.73|-13.24|<0.001
72424365|NCT04867785|144359720|SUPERIORITY||LSMean Difference|-1.19||||0.135|TWO_SIDED|95.0|-2.75|0.37|||Mixed Models Analysis|||||0.37|-2.75|0.135
72424366|NCT04867785|144359720|SUPERIORITY||LSMean Difference|-5.11|||<|0.001|TWO_SIDED|95.0|-7.36|-2.86|||Mixed Models Analysis|||||-2.86|-7.36|<0.001
72424367|NCT04867785|144359720|SUPERIORITY||LSMean Difference|-7.48|||<|0.001|TWO_SIDED|95.0|-10.19|-4.77|||Mixed Models Analysis|||||-4.77|-10.19|<0.001
72424368|NCT04867785|144359720|SUPERIORITY||LSMean Difference|-10.83|||<|0.001|TWO_SIDED|95.0|-12.89|-8.77|||Mixed Models Analysis|||||-8.77|-12.89|<0.001
72424369|NCT04867785|144359720|SUPERIORITY||LSMean Difference|-12.76|||<|0.001|TWO_SIDED|95.0|-15.74|-9.77|||Mixed Models Analysis|||||-9.77|-15.74|<0.001
72424370|NCT04867785|144359720|SUPERIORITY||LSMean Difference|-11.69|||<|0.001|TWO_SIDED|95.0|-13.9|-9.47|||Mixed Models Analysis|||||-9.47|-13.90|<0.001
72424371|NCT04867785|144359721|SUPERIORITY||LSMean Difference|-0.03||||0.979|TWO_SIDED|95.0|-2.18|2.12|||Mixed Models Analysis|||||2.12|-2.18|0.979
72424372|NCT04867785|144359721|SUPERIORITY||LSMean Difference|-4.0||||0.018|TWO_SIDED|95.0|-7.32|-0.68|||Mixed Models Analysis|||||-0.68|-7.32|0.018
72424373|NCT04867785|144359721|SUPERIORITY||LSMean Difference|-7.09|||<|0.001|TWO_SIDED|95.0|-10.46|-3.71|||Mixed Models Analysis|||||-3.71|-10.46|<0.001
72424374|NCT04867785|144359721|SUPERIORITY||LSMean Difference|-13.2|||<|0.001|TWO_SIDED|95.0|-16.74|-9.66|||Mixed Models Analysis|||||-9.66|-16.74|<0.001
72424375|NCT04867785|144359721|SUPERIORITY||LSMean Difference|-12.84|||<|0.001|TWO_SIDED|95.0|-16.5|-9.18|||Mixed Models Analysis|||||-9.18|-16.50|<0.001
72424376|NCT04867785|144359721|SUPERIORITY||LSMean Difference|-13.91|||<|0.001|TWO_SIDED|95.0|-17.1|-10.71|||Mixed Models Analysis|||||-10.71|-17.10|<0.001
72424377|NCT04867785|144359721|SUPERIORITY||LSMean Difference|-1.34||||0.213|TWO_SIDED|95.0|-3.45|0.77|||Mixed Models Analysis|||||0.77|-3.45|0.213
72424378|NCT04867785|144359721|SUPERIORITY||LSMean Difference|-5.31||||0.002|TWO_SIDED|95.0|-8.66|-1.97|||Mixed Models Analysis|||||-1.97|-8.66|0.002
72424379|NCT04867785|144359721|SUPERIORITY||LSMean Difference|-8.4|||<|0.001|TWO_SIDED|95.0|-11.76|-5.04|||Mixed Models Analysis|||||-5.04|-11.76|<0.001
72424380|NCT04867785|144359721|SUPERIORITY||LSMean Difference|-14.51|||<|0.001|TWO_SIDED|95.0|-18.0|-11.01|||Mixed Models Analysis|||||-11.01|-18.00|<0.001
72424381|NCT04867785|144359721|SUPERIORITY||LSMean Difference|-14.15|||<|0.001|TWO_SIDED|95.0|-17.77|-10.54|||Mixed Models Analysis|||||-10.54|-17.77|<0.001
72424382|NCT04867785|144359721|SUPERIORITY||LSMean Difference|-15.22|||<|0.001|TWO_SIDED|95.0|-18.36|-12.07|||Mixed Models Analysis|||||-12.07|-18.36|<0.001
72424383|NCT03926065|144359730|SUPERIORITY|||||||0.126|||||||Mixed Models Analysis|||Standard Palatability (Standard Portion Size and Larger Portion Size) compared to Enhanced Palatability (Standard Portion Size and Larger Portion Size)||||0.1260
72424384|NCT03926065|144359730|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||Standard Portion Size (Standard Palatability and Enhanced Palatability) compared to Larger Portion Size (Standard Palatability and Enhanced Palatability)||||<0.0001
72424385|NCT03926065|144359730|SUPERIORITY|||||||0.0992|||||||Mixed Models Analysis|||Interaction between Portion Size and Palatability||||0.0992
72424386|NCT03926065|144359731|SUPERIORITY|||||||0.5502|||||||Mixed Models Analysis|||Standard Palatability (Standard Portion Size and Larger Portion Size) compared to Enhanced Palatability (Standard Portion Size and Larger Portion Size)||||0.5502
72424387|NCT03926065|144359731|SUPERIORITY|||||||0.0072|||||||Mixed Models Analysis|||Standard Portion Size (Standard Palatability and Enhanced Palatability) compared to Larger Portion Size (Standard Palatability and Enhanced Palatability)||||0.0072
72424388|NCT03926065|144359732|SUPERIORITY|||||||0.103|||||||Mixed Models Analysis|||Standard Palatability (Standard Portion Size and Larger Portion Size) compared to Enhanced Palatability (Standard Portion Size and Larger Portion Size)||||0.1030
72424389|NCT03926065|144359732|SUPERIORITY|||||||0.0178|||||||Mixed Models Analysis|||Standard Portion Size (Standard Palatability and Enhanced Palatability) compared to Larger Portion Size (Standard Palatability and Enhanced Palatability)||||0.0178
72424390|NCT03926065|144359732|SUPERIORITY|||||||0.241|||||||Mixed Models Analysis|||Interaction between Portion Size and Palatability||||0.2410
72424391|NCT03926065|144359733|SUPERIORITY|||||||0.0012|||||||Mixed Models Analysis|||Standard Palatability (Standard Portion Size and Larger Portion Size) compared to Enhanced Palatability (Standard Portion Size and Larger Portion Size)||||0.0012
72424392|NCT03926065|144359733|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||Standard Portion Size (Standard Palatability and Enhanced Palatability) compared to Larger Portion Size (Standard Palatability and Enhanced Palatability)||||<0.0001
72424393|NCT03239873|144359737|NON_INFERIORITY|The conclusion of non-inferiority (similarity) is based on the lower bound of the 2-sided 95% CI on the risk difference excluding a decrease equal to or more than the prespecified criterion of 10.0 percentage points for Varicella zoster virus.|Risk Difference (RD)|0.0|||<|0.001|TWO_SIDED|95.0|-2.7|2.8|||Miettinen and Nurminen|||||2.8|-2.7|<0.001
72424394|NCT03239873|144359737|OTHER|Acceptability|Antibody Response Rate|98.4|||<|0.001|TWO_SIDED|95.0|95.9|99.6|||Exact CI method/binomial proportion|||The conclusion of acceptability is based on the lower bound of the 95% Confidence Interval (CI) being \>76%, and implies that the value of the parameter is statistically significantly greater than the prespecified acceptability criterion (76%).||99.6|95.9|<0.001
72424395|NCT03239873|144359738|NON_INFERIORITY|The statistical criterion for noninferiority of the GMT corresponds to the lower bound of the 2-sided 95% CI on the GMT ratio \[VARIVAX® PE34 process/VARIVAX® 2016 commercial product\] being \>0.67.|Risk Difference (RD)|1.0|||<|0.001|TWO_SIDED|95.0|0.9|1.1|||Miettinen and Nurminen|||||1.1|0.9|<0.001
72424396|NCT03239873|144359739|OTHER||Difference in Percentage|2.0||||0.436|TWO_SIDED|95.0|-3.1|7.1|||Miettinen & Nurminen|||Up to 42 days after Vaccination 1||7.1|-3.1|0.436
72424397|NCT03239873|144359739|OTHER||Difference in Percentage|2.9||||0.204|TWO_SIDED|95.0|-1.6|7.5|||Miettinen & Nurminen|||Up to 42 days after Vaccination 2||7.5|-1.6|0.204
72424398|NCT03239873|144359740|OTHER||Difference in Percentage|-1.3||||0.102|TWO_SIDED|95.0|-3.5|0.4|||Miettinen & Nurminen|||Measles-like rash||0.4|-3.5|0.102
72424399|NCT03239873|144359740|OTHER||Difference in Percentage|0.3||||0.317|TWO_SIDED|95.0|-0.9|1.9|||Miettinen & Nurminen|||Rubella-like rash||1.9|-0.9|0.317
72424400|NCT03239873|144359740|OTHER||Difference in Percentage|1.3||||0.241||95.0|-1.0|4.0|||Miettinen & Nurminen|||Varicella-like rash||4.0|-1.0|0.241
72424401|NCT03239873|144359740|OTHER||Difference in Percentage|-0.3||||0.318|TWO_SIDED|95.0|-1.9|0.9|||Miettinen & Nurminen|||Zoster-like rash||0.9|-1.9|0.318
72424402|NCT03239873|144359741|OTHER||Difference in Percentage|1.1||||0.17|TWO_SIDED|95.0|-0.7|3.4|||Miettinen & Nurminen|||Measles-like rash||3.4|-0.7|0.170
72424403|NCT03239873|144359741|OTHER||Difference in Percentage|-0.3||||0.576|TWO_SIDED|95.0|-2.2|1.4|||Miettinen & Nurminen|||Varicella-like rash||1.4|-2.2|0.576
72424404|NCT03239873|144359741|OTHER||Difference in Percentage|0.4||||0.312|TWO_SIDED|95.0|-1.0|2.0|||Miettinen & Nurminen|||Zoster-like rash||2.0|-1.0|0.312
72424405|NCT03239873|144359742|OTHER||Difference of Percentage|-1.0||||0.696|TWO_SIDED|95.0|-5.9|4.0|||Miettinen & Nurminen|||Injection site erythema||4.0|-5.9|0.696
72424406|NCT03239873|144359742|OTHER||Difference in Percentage|0.7||||0.796|TWO_SIDED|95.0|-4.7|6.2|||Miettinen & Nurminen|||Injection site pain||6.2|-4.7|0.796
72424407|NCT03239873|144359742|OTHER||Difference in Percentage|-2.7||||0.111||95.0|-6.2|0.7|||Miettinen & Nurminen|||Injection site swelling||0.7|-6.2|0.111
72424408|NCT03239873|144359743|OTHER||Difference in Percentage|-0.3||||0.931|TWO_SIDED|95.0|-6.9|6.4|||Miettinen & Nurminen|||Injection site erythema||6.4|-6.9|0.931
72424409|NCT03239873|144359743|OTHER||Difference in Percentage|-1.6||||0.523|TWO_SIDED|95.0|-6.6|3.4|||Miettinen & Nurminen|||Injection site pain||3.4|-6.6|0.523
72424410|NCT03239873|144359743|OTHER||Difference in Percentage|2.0||||0.415|TWO_SIDED|95.0|-2.9|6.9|||Miettinen & Nurminen|||Injection site swelling||6.9|-2.9|0.415
72424411|NCT03239873|144359744|OTHER||Difference in Percentage|1.6|||||TWO_SIDED|95.0|-3.4|6.7|||||Miettinen \& Nurminen|||6.7|-3.4|
72424412|NCT03239873|144359745|OTHER||Difference in Percentage|0.0|||||TWO_SIDED|95.0|-2.5|2.6|||||Miettinen \& Nurminen|||2.6|-2.5|
72424413|NCT03239873|144359746|OTHER||Difference in Percentage|1.9|||||TWO_SIDED|95.0|-6.1|9.8|||||Miettinen \& Nurminen|||9.8|-6.1|
72424414|NCT03239873|144359747|OTHER||Difference in Percentage|2.3|||||TWO_SIDED|95.0|-4.7|9.2|||||Miettinen \& Nurminen|||9.2|-4.7|
72424415|NCT03239873|144359752|OTHER||Difference in Percentage|0.0|||||TWO_SIDED|95.0|-1.3|1.3|||||Miettinen \& Nurminen|||1.3|-1.3|
72424416|NCT03239873|144359753|OTHER||Difference in Percentage|0.0|||||TWO_SIDED|95.0|-1.3|1.3|||||Miettinen \& Nurminen|||1.3|-1.3|
72424417|NCT03239873|144359756|OTHER||Difference in Percentage|2.9|||||TWO_SIDED|95.0|-4.6|10.3|||||Miettinen and Nurminen|||10.3|-4.6|
72424418|NCT02670538|144359767|SUPERIORITY||Least Squares (LS) Mean Difference|-2.5||||0.0417|TWO_SIDED|95.0|-4.6|-0.4||Adjusted p-value: adjustment was performed using matched parallel gatekeeping procedure to control the overall type I error rate for multiple comparisons of 2 active doses versus placebo at Week 6.|Contrast t-test|||||-0.4|-4.6|0.0417
72424419|NCT02670538|144359767|SUPERIORITY||LS Mean Difference|-1.8||||0.1051|TWO_SIDED|95.0|-3.9|0.4||Adjusted p-value: adjustment was performed using matched parallel gatekeeping procedure to control the overall type I error rate for multiple comparisons of 2 active doses versus placebo at Week 6.|Contrast t-test|||||0.4|-3.9|0.1051
72424420|NCT02670538|144359768|SUPERIORITY||LS Mean Difference|-0.3||||0.0417|TWO_SIDED|95.0|-0.6|-0.1||Adjusted p-value: adjustment was performed using matched parallel gatekeeping procedure to control the overall type I error rate for multiple comparisons of 2 active doses versus placebo at Week 6.|Contrast t-test|||||-0.1|-0.6|0.0417
72424421|NCT02670538|144359768|SUPERIORITY||LS Mean Difference|-0.2||||0.137|TWO_SIDED|95.0|-0.4|0.1||Adjusted p-value: adjustment was performed using matched parallel gatekeeping procedure to control the overall type I error rate for multiple comparisons of 2 active doses versus placebo at Week 6.|Contrast t-test|||||0.1|-0.4|0.1370
72424422|NCT01250119|144359771|SUPERIORITY_OR_OTHER|||||||0|TWO_SIDED||||||Wald Test|Test for difference in incidence of EGFR mutations for each subgroup controlled for histopathology; Univariate analysis.||||||0.0000
72424423|NCT01250119|144359771|SUPERIORITY_OR_OTHER|||||||0.1038|TWO_SIDED||||||Wald Test|Test for difference in incidence of EGFR mutations for each subgroup controlled for histopathology; Multivariate analysis (6 main effects only).||||||0.1038
72424424|NCT01250119|144359771|SUPERIORITY_OR_OTHER|||||||0.0588|TWO_SIDED||||||Wald Test|Test for difference in incidence of EGFR mutations for each subgroup controlled for stage of disease; Univariate analysis.||||||0.0588
72424425|NCT01250119|144359771|SUPERIORITY_OR_OTHER|||||||0.4802|TWO_SIDED||||||Wald Test|Test for difference in incidence of EGFR mutations for each subgroup controlled for stage of disease; Multivariate analysis (6 main effects only).||||||0.4802
72424426|NCT01250119|144359771|SUPERIORITY_OR_OTHER|||||||0.0147|TWO_SIDED||||||Wald Test|Test for difference in incidence of EGFR mutations for each subgroup controlled for age at consent; Multivariate analysis (6 main effects only).||||||0.0147
72424427|NCT01250119|144359771|SUPERIORITY_OR_OTHER|||||||0.1181|TWO_SIDED||||||Wald Test|Test for difference in incidence of EGFR mutations for each subgroup controlled for age at consent; Multivariate analysis (6 main effects only).||||||0.1181
72424428|NCT01250119|144359771|SUPERIORITY_OR_OTHER|||||||0|TWO_SIDED||||||Wald Test|Test for difference in incidence of EGFR mutations for each subgroup controlled for gender; Univariate analysis.||||||0.0000
72424429|NCT01250119|144359771|SUPERIORITY_OR_OTHER|||||||0.0006|TWO_SIDED||||||Wald Test|Test for difference in incidence of EGFR mutations for each subgroup controlled for gender; Multivariate analysis (6 main effects only).||||||0.0006
72424430|NCT01250119|144359771|SUPERIORITY_OR_OTHER|||||||0.0004|TWO_SIDED||||||Wald Test|Test for difference in incidence of EGFR mutations for each subgroup controlled for race; Univariate analysis.||||||0.0004
72424431|NCT01250119|144359771|SUPERIORITY_OR_OTHER|||||||0.3371|TWO_SIDED||||||Wald Test|Test for difference in incidence of EGFR mutations for each subgroup controlled for race; Multivariate analysis (6 main effects only).||||||0.3371
72424432|NCT01250119|144359771|SUPERIORITY_OR_OTHER|||||||0|TWO_SIDED||||||Wald Test|Test for difference in incidence of EGFR mutations for each subgroup controlled for smoking history; Univariate analysis.||||||0.0000
72424433|NCT01250119|144359771|SUPERIORITY_OR_OTHER|||||||0.0001|TWO_SIDED||||||Wald Test|Test for difference in incidence of EGFR mutations for each subgroup controlled for smoking history; Multivariate analysis (6 main effects only).||||||0.0001
72424434|NCT02887989|144359783|SUPERIORITY|||||||0.657|||||||t-test, 2 sided|||||||.6570
72424435|NCT02887989|144359784|SUPERIORITY|||||||0.6339|||||||t-test, 2 sided|||||||.6339
72424436|NCT00708526|144359799|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05||95.0|||||t-test, 2 sided|A Bonferroni correction was used.||We compared times for discharge criteria after general anesthesia with and without the QED.||||>0.05
72424437|NCT00708526|144359800|SUPERIORITY_OR_OTHER_LEGACY|||||||0.039||95.0|||||t-test, 2 sided|||The effect of the use of hypercapnia and increased ventilation on the time to recovery events was compared using multivariate analysis of variance with the Hotelling's two sample T2.-test and the two-tailed unpaired t-test; individual comparisons were by Bonferroni adjusted two tailed unpaired t-tests. The data was tested for normality before identifying statistical significance.||||0.039
72424438|NCT01077362|144359845|SUPERIORITY_OR_OTHER||||||<|0.001|||||||re-randomization test|||||||<0.001
72424439|NCT01077362|144359845|SUPERIORITY_OR_OTHER||||||<|0.001|||||||re-randomization test|||||||<0.001
72333887|NCT01559259|144191640|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|3.55|||<|0.001|TWO_SIDED|95.0|2.79|4.31|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||4.31|2.79|<0.001
72424440|NCT01077362|144359845|SUPERIORITY_OR_OTHER||||||<|0.001|||||||re-randomization test|||||||<0.001
72424441|NCT01077362|144359846|SUPERIORITY_OR_OTHER|||||||0.002|||||||re-randomization test|||||||0.002
72424442|NCT01077362|144359846|SUPERIORITY_OR_OTHER||||||<|0.001|||||||re-randomization test|||||||<0.001
72424443|NCT01077362|144359846|SUPERIORITY_OR_OTHER||||||<|0.001|||||||re-randomization test|||||||<0.001
72424444|NCT01077362|144359847|SUPERIORITY_OR_OTHER||||||<|0.001|||||||re-randomization test|||||||<0.001
72424445|NCT01077362|144359847|SUPERIORITY_OR_OTHER||||||<|0.001|||||||re-randomization test|||||||<0.001
72333888|NCT01559259|144191640|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|4.03|||<|0.001|TWO_SIDED|95.0|3.27|4.79|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||4.79|3.27|<0.001
72333889|NCT01559259|144191640|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|3.48|||<|0.001|TWO_SIDED|95.0|2.72|4.24|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||4.24|2.72|<0.001
72424446|NCT01077362|144359847|SUPERIORITY_OR_OTHER||||||<|0.001|||||||re-randomization test|||||||<0.001
72424447|NCT01077362|144359848|SUPERIORITY_OR_OTHER|||||||0.018|||||||re-randomization test|||||||0.018
72424448|NCT01077362|144359848|SUPERIORITY_OR_OTHER||||||<|0.001|||||||re-randomization test|||||||<0.001
72424449|NCT01077362|144359848|SUPERIORITY_OR_OTHER|||||||0.002|||||||re-randomization test|||||||0.002
72424450|NCT01077362|144359849|SUPERIORITY_OR_OTHER|||||||0.017|||||||re-randomization test|||||||0.017
72424451|NCT01077362|144359849|SUPERIORITY_OR_OTHER||||||<|0.001|||||||re-randomization test|||||||<0.001
72424452|NCT01077362|144359849|SUPERIORITY_OR_OTHER||||||<|0.001|||||||re-randomization test|||||||<0.001
72424453|NCT01077362|144359850|SUPERIORITY_OR_OTHER|||||||0.171|||||||re-randomization|||||||0.171
72424454|NCT01077362|144359850|SUPERIORITY_OR_OTHER|||||||0.06|||||||re-randomization test|||||||0.060
72424455|NCT01077362|144359850|SUPERIORITY_OR_OTHER|||||||0.094|||||||re-randomization|||||||0.094
72424456|NCT01641926|144359856|SUPERIORITY_OR_OTHER||Adjusted Treatment Difference|1.6|||||TWO_SIDED|95.0|-8.4|11.6||||||The treatment difference in the rates (PEG-Intron arm minus PEGASYS™ arm) and its 95% confidence interval adjusted for the baseline stratification factor (hepatitis B Virus \[HBV\] genotype) was computed using the method of Miettinen and Nurminen weighted by stratum sample size.||11.6|-8.4|
72424457|NCT01641926|144359857|SUPERIORITY_OR_OTHER||Adjusted Treatment Difference|-3.0|||||TWO_SIDED|95.0|-20.2|14.3||||||The treatment difference in the rates (PEG-Intron arm minus PEGASYS™ arm) and its 95% confidence interval adjusted for the baseline stratification factor (HBV genotype) was computed using the method of Miettinen and Nurminen weighted by stratum sample size.||14.3|-20.2|
72424458|NCT01641926|144359858|SUPERIORITY_OR_OTHER||Adjusted Treatment Difference|2.6|||||TWO_SIDED|95.0|-7.2|12.3||||||The treatment difference in the rates (PEG-Intron arm minus PEGASYS™ arm) and its 95% confidence interval adjusted for the baseline stratification factor (HBV genotype) was computed using the method of Miettinen and Nurminen weighted by stratum sample size.||12.3|-7.2|
72424459|NCT01641926|144359859|SUPERIORITY_OR_OTHER||Adjusted Treatment Difference|2.1|||||TWO_SIDED|95.0|-9.5|13.6||||||The treatment difference in the rates (PEG-Intron arm minus PEGASYS™ arm) and its 95% confidence interval adjusted for the baseline stratification factor (HBV genotype) was computed using the method of Miettinen and Nurminen weighted by stratum sample size.||13.6|-9.5|
72424460|NCT01641926|144359859|SUPERIORITY_OR_OTHER||Adjusted Treatment Difference|10.1|||||TWO_SIDED|95.0|-7.2|27.1||||||The treatment difference in the rates (PEG-Intron arm minus PEGASYS™ arm) and its 95% confidence interval adjusted for the baseline stratification factor (HBV genotype) was computed using the method of Miettinen and Nurminen weighted by stratum sample size.||27.1|-7.2|
72424461|NCT01641926|144359860|SUPERIORITY_OR_OTHER||Adjusted Treatment Difference|0.9|||||TWO_SIDED|95.0|-7.4|9.2||||||The treatment difference in the rates (PEG-Intron arm minus PEGASYS™ arm) and its 95% confidence interval adjusted for the baseline stratification factor (HBV genotype) was computed using the method of Miettinen and Nurminen weighted by stratum sample size.||9.2|-7.4|
72424462|NCT02294630|144359863|OTHER|||||||0.399|||||||t-test, 2 sided|||||||0.399
72424463|NCT02567825|144359883|SUPERIORITY||Risk Ratio (RR)|0.97||||0.66|TWO_SIDED|95.0|0.84|1.12|||Generalized linear model|The p-value is adjusted for site, age at enrollment, and exposure or nonexposure to other children.|The Surgical Management group represents the numerator for the risk ratio and the Non-Surgical Management group represents the denominator. The estimates are adjusted for site, age at enrollment, and exposure or nonexposure to other children.|Null hypothesis: There is no difference between the two groups in the rate of occurrence of AOM per child-year during the 2-year follow-up period.||1.12|0.84|0.66
72424464|NCT02567825|144359884|SUPERIORITY||Risk Ratio (RR)|0.82|||||TWO_SIDED|95.0|0.67|1.01|||||The Surgical Management group represents the numerator for the risk ratio and the Non-Surgical Management group represents the denominator.|Null hypothesis: There is no difference between the two groups in the rate of occurrence of AOM per child-year during the 2 year follow-up among children considered at low risk of AOM recurrences at enrollment..||1.01|0.67|
72424465|NCT02567825|144359884|SUPERIORITY||Risk Ratio (RR)|1.07|||||TWO_SIDED|95.0|0.86|1.33|||||The Surgical Management group represents the numerator for the risk ratio and the Non-Surgical Management group represents the denominator.|Null hypothesis: There is no difference between the two groups in the rate of occurrence of AOM per child-year during the 2 year follow-up among children considered at high risk of AOM recurrences at enrollment.||1.33|0.86|
72424466|NCT02567825|144359884|OTHER|||||||0.08|||||||Generalized linear models|||Null hypothesis: There is no interaction between comparison group (Surgical Management, Non-Surgical Management) and risk group (children considered at low risk of AOM recurrences at enrollment, children considered at high risk of AOM recurrences at enrollment).||||0.08
72424467|NCT02567825|144359885|SUPERIORITY|||||||0.48|||||||Chi-squared|||"Null hypothesis: There is no difference between the two groups in the proportion of children completing the study with 0, 1 or 2, 3 or 4, greater than or equal to 5 episodes of AOM.~."||||0.48
72424468|NCT02567825|144359886|SUPERIORITY||Risk Ratio (RR)|0.73|||||TWO_SIDED|95.0|0.58|0.92|||||The Surgical Management group represents the numerator for the risk ratio and the Non-Surgical Management group represents the denominator. The estimates are adjusted for site, age at enrollment, and exposure or nonexposure to other children.|Null hypothesis: There is no difference between the two groups in the proportion of children experiencing treatment failure.||0.92|0.58|
72424469|NCT02567825|144359887|SUPERIORITY||Hazard Ratio (HR)|0.68|||||TWO_SIDED|95.0|0.52|0.9|||||The Surgical Management group represents the numerator for the hazard ratio and the Non-Surgical Management group represents the denominator. The estimates are adjusted for site, age at enrollment, and exposure or nonexposure to other children.|Null hypothesis: There is no difference between the two groups regarding the time to the first episode of AOM.||0.90|0.52|
72424470|NCT02567825|144359888|SUPERIORITY||Risk Ratio (RR)|0.91|||||TWO_SIDED|95.0|0.76|1.09|||||The Surgical Management group represents the numerator for the risk ratio and the Non-Surgical Management group represents the denominator. The estimates are adjusted for site, age at enrollment, and exposure or nonexposure to other children.|Null hypothesis: There is no difference between the two groups in the proportion of episodes categorized as probably severe.||1.09|0.76|
72424471|NCT02567825|144359889|SUPERIORITY||Risk Ratio (RR)|0.34|||||TWO_SIDED|95.0|0.26|0.44||||||Null hypothesis: There is no difference between the two groups in the proportion of episodes presenting with tympanic membrane bulging rather than otorrhea|The Surgical Management group represents the numerator for the risk ratio and the Non-Surgical Management group represents the denominator. The estimates are adjusted for site, age at enrollment, and exposure or nonexposure to other children.|0.44|0.26|
72424472|NCT02567825|144359890|SUPERIORITY||Difference of least-squares means|5.21|||||TWO_SIDED|95.0|2.6|7.82|||||The Surgical Management group represents the first number in the subtraction and the Non-Surgical Management group represents the second. The estimates are adjusted for site, age at enrollment, and exposure or nonexposure to other children.|Null hypothesis: There is no difference between the two groups in the mean days per year children experience tube otorrhea. The analysis uses a weighted regression model with weights equal to the length of follow-up.||7.82|2.60|
72424473|NCT02567825|144359891|SUPERIORITY||Difference of least-squares means|-6.32|||||TWO_SIDED|95.0|-7.55|-5.1|||||The Surgical Management group represents the first number in the subtraction and the Non-Surgical Management group represents the second. The estimates are adjusted for site, age at enrollment, and exposure or nonexposure to other children.|Null hypothesis: There is no difference between the two groups in the mean days per year children experience AOM symptoms with an intact TM. The analysis uses a weighted regression model with weights equal to the length of follow-up.||-5.10|-7.55|
72424474|NCT02567825|144359892|SUPERIORITY||Difference of least-squares means|-4.5|||||TWO_SIDED|95.0|-6.82|-2.18|||||The Surgical Management group represents the first number in the subtraction and the Non-Surgical Management group represents the second. The estimates are adjusted for site, age at enrollment, and exposure or nonexposure to other children.|Null hypothesis: There is no difference between the two groups in the mean days per year children receive systemic antimicrobials for AOM. The analysis uses a weighted regression model with weights equal to the length of follow-up.||-2.18|-6.82|
72424475|NCT02567825|144359893|SUPERIORITY||Risk Ratio (RR)|0.67|||||TWO_SIDED|95.0|0.44|1.03|||||The Surgical Management group represents the numerator for the hazard ratio and the Non-Surgical Management group represents the denominator. The estimates are adjusted for site, age at enrollment, and exposure or nonexposure to other children.|Null hypothesis: There is no difference between the two groups regarding the proportion of children for whom PDD was reported.||1.03|0.44|
72424476|NCT02567825|144359894|SUPERIORITY||Risk Ratio (RR)|0.79|||||TWO_SIDED|95.0|0.51|1.22|||||The Surgical Management group represents the numerator for the risk ratio and the Non-Surgical Management group represents the denominator. The estimates are adjusted for site, age at enrollment, and exposure or nonexposure to other children.|Null hypothesis: There is no difference between the two groups regarding the proportion of children for whom diaper dermatitis was reported.||1.22|0.51|
72424477|NCT02567825|144359895|SUPERIORITY||Risk Ratio (RR)|2.57|||||TWO_SIDED|95.0|1.91|3.48|||||The Surgical Management group represents the numerator for the risk ratio and the Non-Surgical Management group represents the denominator. The estimates are adjusted for site, age at enrollment, and exposure or nonexposure to other children.|Null hypothesis: There is no difference between the two groups regarding the proportion of children for whom tube otorrhea was reported.||3.48|1.91|
72424478|NCT02567825|144359896|SUPERIORITY||Risk Ratio (RR)|0.96|||||TWO_SIDED|95.0|0.74|1.24|||||The Surgical Management group represents the numerator for the risk ratio and the Non-Surgical Management group represents the denominator. The estimates are adjusted for site, age at enrollment, and exposure or nonexposure to other children.|Null hypothesis: There is no difference between the two groups in the proportion of children with no pathogens at enrollment having a penicillin-nonsusceptible nasopharyngeal or throat isolate at some follow-up visit.||1.24|0.74|
72424479|NCT02567825|144359896|SUPERIORITY||Risk Ratio (RR)|1.2|||||TWO_SIDED|95.0|0.83|1.72|||||The Surgical Management group represents the numerator for the risk ratio and the Non-Surgical Management group represents the denominator. The estimates are adjusted for site, age at enrollment, and exposure or nonexposure to other children.|Null hypothesis: There is no difference between the two groups in the proportion of children positive only for at least 1 penicillin-susceptible pathogen at enrollment having a penicillin-nonsusceptible nasopharyngeal or throat isolate at some follow-up visit.||1.72|0.83|
72424480|NCT02567825|144359896|SUPERIORITY||Risk Ratio (RR)|1.1|||||TWO_SIDED|95.0|0.94|1.29|||||The Surgical Management group represents the numerator for the risk ratio and the Non-Surgical Management group represents the denominator. The estimates are adjusted for site, age at enrollment, and exposure or nonexposure to other children.|Null hypothesis: There is no difference between the two groups in the proportion of children positive for at least 1 penicillin nonsusceptible pathogen at enrollment having a penicillin-nonsusceptible nasopharyngeal or throat isolate at some follow-up visit.||1.29|0.94|
72424481|NCT02567825|144359897|SUPERIORITY||Risk Ratio (RR)|1.14|||||TWO_SIDED|95.0|0.84|1.55|||||The Surgical Management group represents the numerator for the risk ratio and the Non-Surgical Management group represents the denominator. The estimates are adjusted for site, age at enrollment, and exposure or nonexposure to other children.|Null hypothesis: There is no difference between the two groups in the proportion of episodes of AOM at which a nonsusceptible pathogen is recovered.||1.55|0.84|
72424482|NCT02567825|144359898|SUPERIORITY||Risk Ratio (RR)|1.09|||||TWO_SIDED|95.0|0.84|1.41|||||The Surgical Management group represents the numerator for the risk ratio and the Non-Surgical Management group represents the denominator. The estimates are adjusted for site, age at enrollment, and exposure or nonexposure to other children.|Null hypothesis: There is no difference between the two groups in the proportion of routine non-illness visits at which a nonsusceptible pathogen is recovered.||1.41|0.84|
72424483|NCT02567825|144359899|SUPERIORITY|The analysis was ITT. The participants are randomized children with at least one episode of AOM late during the respiratory season at which a nasopharyngeal or throat culture is obtained.|Risk Ratio (RR)|1.16|||||TWO_SIDED|95.0|0.69|1.95|||||The Surgical Management group represents the numerator for the risk ratio and the Non-Surgical Management group represents the denominator.|||1.95|0.69|
72424484|NCT02567825|144359900|SUPERIORITY||Difference of least-squares means|0.25|||||TWO_SIDED|95.0|-0.06|0.56|||||The Surgical Management group represents the first number in the subtraction and the Non-Surgical Management group represents the second. The estimates are adjusted for site, age at enrollment, and exposure or nonexposure to other children.|Null hypothesis: There is no difference between the two groups in the mean parental satisfaction score||0.56|-0.06|
72424485|NCT02567825|144359901|SUPERIORITY||Risk Ratio (RR)|1.07|||||TWO_SIDED|95.0|0.98|1.18|||||The Surgical Management group represents the numerator for the risk ratio and the Non-Surgical Management group represents the denominator. The estimates are adjusted for site, age at enrollment, and exposure or nonexposure to other children.|Null hypothesis: There is no difference between the two groups in the proportion of parent reports indicating at least one health care encounter since the previous study visit.||1.18|0.98|
72424486|NCT02567825|144359902|SUPERIORITY|Reports for which the parent did not answer the question were excluded from the analysis.|Risk Ratio (RR)|1.11|||||TWO_SIDED|95.0|0.88|1.41|||||The Surgical Management group represents the numerator for the risk ratio and the Non-Surgical Management group represents the denominator. The estimates are adjusted for site, age at enrollment, and exposure or nonexposure to other children.|Null hypothesis: There is no difference between the two groups in the proportion of parent reports indicating a parent missed work due to child's illness.||1.41|0.88|
72424487|NCT02567825|144359903|SUPERIORITY|Reports indicating the parent did not answer the question were excluded from the analysis.|Risk Ratio (RR)|1.15|||||TWO_SIDED|95.0|0.89|1.48|||||The Surgical Management group represents the numerator for the risk ratio and the Non-Surgical Management group represents the denominator. The estimates are adjusted for site, age at enrollment, and exposure or nonexposure to other children.|Null hypothesis: There is no difference between the two groups in the proportion of parent reports indicating the need for special childcare arrangements due to child's illness.||1.48|0.89|
72424488|NCT02567825|144359904|SUPERIORITY||Difference of least-square means|-0.05|||||TWO_SIDED|95.0|-0.13|0.02|||||The Surgical Management group represents the first number in the subtraction and the Non-Surgical Management group represents the second. The estimates are adjusted for site, age at enrollment, and exposure or nonexposure to other children.|Null hypothesis: There is no difference between the two groups in the mean OM-6 survey score||0.02|-0.13|
72333890|NCT01559259|144191640|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.52||||0.056|TWO_SIDED|95.0|-0.01|1.05|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.05|-0.01|0.056
72424489|NCT02567825|144359904|SUPERIORITY||Difference of least-square means|0.06|||||TWO_SIDED|95.0|-0.13|0.24|||||The Surgical Management group represents the first number in the subtraction and the Non-Surgical Management group represents the second. The estimates are adjusted for site, age at enrollment, and exposure or nonexposure to other children.|Null hypothesis: There is no difference between the two groups in the mean OM-6 survey--children's overall QOL score.||0.24|-0.13|
72333891|NCT01559259|144191640|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.07||||0.789|TWO_SIDED|95.0|-0.46|0.6|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.60|-0.46|0.789
72333892|NCT01559259|144191640|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.55||||0.042|TWO_SIDED|95.0|0.02|1.08|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.08|0.02|0.042
72333893|NCT01559259|144191640|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|4.17|||<|0.001|TWO_SIDED|95.0|3.37|4.98|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||4.98|3.37|<0.001
72333894|NCT01559259|144191640|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|3.86|||<|0.001|TWO_SIDED|95.0|3.06|4.66|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||4.66|3.06|<0.001
72333895|NCT01559259|144191640|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|4.34|||<|0.001|TWO_SIDED|95.0|3.54|5.14|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||5.14|3.54|<0.001
72424490|NCT02567825|144359905|SUPERIORITY||Difference of least-square means|-0.04|||||TWO_SIDED|95.0|-1.55|1.47|||||The Surgical Management group represents the first number in the subtraction and the Non-Surgical Management group represents the second. The estimates are adjusted for site, age at enrollment, and exposure or nonexposure to other children.|Null hypothesis: There is no difference between the two groups in the mean caregiver impact questionnaire score.||1.47|-1.55|
72333896|NCT01559259|144191640|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|3.89|||<|0.001|TWO_SIDED|95.0|3.09|4.69|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||4.69|3.09|<0.001
72333897|NCT01559259|144191640|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.29||||0.317|TWO_SIDED|95.0|-0.28|0.85|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.85|-0.28|0.317
72333898|NCT01559259|144191640|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.03||||0.922|TWO_SIDED|95.0|-0.59|0.53|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.53|-0.59|0.922
72333899|NCT01559259|144191640|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.45||||0.112|TWO_SIDED|95.0|-0.11|1.02|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.02|-0.11|0.112
72333900|NCT01559259|144191640|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|4.1|||<|0.001|TWO_SIDED|95.0|3.27|4.94|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||4.94|3.27|<0.001
72333901|NCT01559259|144191640|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|3.76|||<|0.001|TWO_SIDED|95.0|2.92|4.59|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||4.59|2.92|<0.001
72333902|NCT01559259|144191640|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|4.15|||<|0.001|TWO_SIDED|95.0|3.32|4.99|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||4.99|3.32|<0.001
72333903|NCT01559259|144191640|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|3.89|||<|0.001|TWO_SIDED|95.0|3.05|4.72|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||4.72|3.05|<0.001
72333904|NCT01559259|144191640|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.22||||0.464|TWO_SIDED|95.0|-0.37|0.81|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.81|-0.37|0.464
72333905|NCT01559259|144191640|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.13||||0.667|TWO_SIDED|95.0|-0.71|0.45|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.45|-0.71|0.667
72333906|NCT01559259|144191640|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.27||||0.368|TWO_SIDED|95.0|-0.32|0.86|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.86|-0.32|0.368
72333907|NCT01559259|144191640|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|3.94|||<|0.001|TWO_SIDED|95.0|3.08|4.81|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||4.81|3.08|<0.001
72333908|NCT01559259|144191640|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|3.63|||<|0.001|TWO_SIDED|95.0|2.77|4.49|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||4.49|2.77|<0.001
72333909|NCT01559259|144191640|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|4.06|||<|0.001|TWO_SIDED|95.0|3.19|4.92|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||4.92|3.19|<0.001
72333910|NCT01559259|144191640|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|3.68|||<|0.001|TWO_SIDED|95.0|2.82|4.54|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||4.54|2.82|<0.001
72333911|NCT01559259|144191640|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.26||||0.397|TWO_SIDED|95.0|-0.34|0.86|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.86|-0.34|0.397
72333912|NCT01559259|144191640|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.05||||0.866|TWO_SIDED|95.0|-0.65|0.55|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.55|-0.65|0.866
72333913|NCT01559259|144191640|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.37||||0.226|TWO_SIDED|95.0|-0.23|0.97|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.97|-0.23|0.226
72333914|NCT01559259|144191640|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|3.8|||<|0.001|TWO_SIDED|95.0|2.9|4.7|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||4.70|2.90|<0.001
72333915|NCT01559259|144191640|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|3.37|||<|0.001|TWO_SIDED|95.0|2.47|4.26|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||4.26|2.47|<0.001
72333916|NCT01559259|144191640|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|3.89|||<|0.001|TWO_SIDED|95.0|2.99|4.79|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||4.79|2.99|<0.001
72333917|NCT01559259|144191640|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|3.6|||<|0.001|TWO_SIDED|95.0|2.7|4.5|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||4.50|2.70|<0.001
72333918|NCT01559259|144191640|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.2||||0.536|TWO_SIDED|95.0|-0.43|0.83|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.83|-0.43|0.536
72333919|NCT01559259|144191640|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.23||||0.467|TWO_SIDED|95.0|-0.86|0.39|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.39|-0.86|0.467
72333920|NCT01559259|144191640|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.29||||0.361|TWO_SIDED|95.0|-0.34|0.92|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.92|-0.34|0.361
72333921|NCT01559259|144191640|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|3.17|||<|0.001|TWO_SIDED|95.0|2.21|4.13|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||4.13|2.21|<0.001
72333922|NCT01559259|144191640|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.99|||<|0.001|TWO_SIDED|95.0|2.04|3.95|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||3.95|2.04|<0.001
72333923|NCT01559259|144191640|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|3.51|||<|0.001|TWO_SIDED|95.0|2.55|4.47|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||4.47|2.55|<0.001
72333924|NCT01559259|144191640|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|3.04|||<|0.001|TWO_SIDED|95.0|2.09|4.0|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||4.00|2.09|<0.001
72333925|NCT01559259|144191640|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.13||||0.704|TWO_SIDED|95.0|-0.54|0.8|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.80|-0.54|0.704
72333926|NCT01559259|144191640|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.05||||0.89|TWO_SIDED|95.0|-0.71|0.62|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.62|-0.71|0.890
72333927|NCT01559259|144191640|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.47||||0.17|TWO_SIDED|95.0|-0.2|1.14|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.14|-0.20|0.170
72333928|NCT01559259|144191640|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.69|||<|0.001|TWO_SIDED|95.0|1.72|3.67|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||3.67|1.72|<0.001
72333929|NCT01559259|144191640|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.58|||<|0.001|TWO_SIDED|95.0|1.61|3.56|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||3.56|1.61|<0.001
72333930|NCT01559259|144191640|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.99|||<|0.001|TWO_SIDED|95.0|2.01|3.97|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||3.97|2.01|<0.001
72333931|NCT01559259|144191640|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.75|||<|0.001|TWO_SIDED|95.0|1.77|3.72|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||3.72|1.77|<0.001
72333932|NCT01559259|144191640|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.05||||0.882|TWO_SIDED|95.0|-0.74|0.63|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.63|-0.74|0.882
72333933|NCT01559259|144191640|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.16||||0.64|TWO_SIDED|95.0|-0.84|0.52|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.52|-0.84|0.640
72424491|NCT02567825|144359905|SUPERIORITY||Difference of least-square means|0.03|||||TWO_SIDED|95.0|-0.14|0.2|||||The Surgical Management group represents the first number in the subtraction and the Non-Surgical Management group represents the second. The estimates are adjusted for site, age at enrollment, and exposure or nonexposure to other children.|Null hypothesis: There is no difference between the two groups in the mean caregiver impact questionnaire--caregiver's overall QOL score.||0.20|-0.14|
72424492|NCT01678820|144359916|SUPERIORITY_OR_OTHER||Difference in least squares means|0.19||||0.267|TWO_SIDED|95.0|-0.14|0.52|||Longitudinal Data Analysis Model|Based on a longitudinal model including terms for region, treatment, time, and the interaction of time by treatment||||0.52|-0.14|0.267
72333934|NCT01559259|144191640|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.24||||0.482|TWO_SIDED|95.0|-0.44|0.93|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.93|-0.44|0.482
72424493|NCT01678820|144359917|SUPERIORITY_OR_OTHER||Difference in percents|-0.4|||||TWO_SIDED|95.0|-10.2|9.3|||||Based on Miettinen \& Nurminen method|||9.3|-10.2|
72424494|NCT01678820|144359917|SUPERIORITY_OR_OTHER||Difference in percents|-4.3|||||TWO_SIDED|95.0|-14.7|5.8|||||Based on Miettinen \& Nurminen method|||5.8|-14.7|
72424495|NCT01678820|144359919|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.62|||<|0.001|TWO_SIDED|95.0|-0.95|-0.28|||Longitudinal Data Analysis Model|Based on a longitudinal model including terms for region, treatment, time, and the interaction of time by treatment.||||-0.28|-0.95|<0.001
72333935|NCT01559259|144191640|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.06|||<|0.001|TWO_SIDED|95.0|1.07|3.06|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||3.06|1.07|<0.001
72333936|NCT01559259|144191640|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.17|||<|0.001|TWO_SIDED|95.0|1.17|3.16|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||3.16|1.17|<0.001
72333937|NCT01559259|144191640|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.24|||<|0.001|TWO_SIDED|95.0|1.25|3.24|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||3.24|1.25|<0.001
72333938|NCT01559259|144191640|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.42|||<|0.001|TWO_SIDED|95.0|1.43|3.41|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||3.41|1.43|<0.001
72333939|NCT01559259|144191640|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.36||||0.314|TWO_SIDED|95.0|-1.05|0.34|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.34|-1.05|0.314
72424496|NCT01678820|144359920|SUPERIORITY_OR_OTHER||Difference in least squares means|1.7||||0.856|TWO_SIDED|95.0|-17.1|20.6|||Longitudinal Data Analysis Model|Based on a longitudinal model including terms for region, treatment, time, and the interaction of time by treatment.||||20.6|-17.1|0.856
72424497|NCT01678820|144359920|SUPERIORITY_OR_OTHER||Difference in least squares means|-29.2||||0.002|TWO_SIDED|95.0|-47.9|-10.6|||Longitudinal Data Analysis Model|Based on a longitudinal model including terms for region, treatment, time, and the interaction of time by treatment.||||-10.6|-47.9|0.002
72424498|NCT01678820|144359921|SUPERIORITY_OR_OTHER||Difference in least squares means|-25.6|||<|0.001|TWO_SIDED|95.0|-35.6|-15.6|||Longitudinal Data Analysis Model|Based on a longitudinal model including terms for region, treatment, time, and the interaction of time by treatment.||||-15.6|-35.6|<0.001
72424499|NCT01678820|144359921|SUPERIORITY_OR_OTHER||Difference in least squares means|5.3||||0.286|TWO_SIDED|95.0|-4.5|15.2|||Longitudinal Data Analysis Model|Based on a longitudinal model including terms for region, treatment, time, and the interaction of time by treatment.||||15.2|-4.5|0.286
72424500|NCT01678820|144359922|SUPERIORITY_OR_OTHER||Difference in least squares means|-18.1|||<|0.001|TWO_SIDED|95.0|-24.2|-12.0|||Longitudinal Data Analysis Model|Based on a longitudinal model including terms for region, treatment, time, and the interaction of time by treatment.||||-12.0|-24.2|<0.001
72333940|NCT01559259|144191640|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.25||||0.469|TWO_SIDED|95.0|-0.95|0.44|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.44|-0.95|0.469
72424501|NCT01678820|144359922|SUPERIORITY_OR_OTHER||Difference in least squares means|0.0||||0.99|TWO_SIDED|95.0|-6.0|6.0|||Longitudinal Data Analysis Model|Based on a longitudinal model including terms for region, treatment, time, and the interaction of time by treatment.||||6.0|-6.0|0.990
72424502|NCT01678820|144359923|SUPERIORITY_OR_OTHER||Difference in least squares means|-20.2|||<|0.001|TWO_SIDED|95.0|-28.3|-12.2|||Longitudinal Data Analysis Model|Based on a longitudinal model including terms for region, treatment, time, and the interaction of time by treatment.||||-12.2|-28.3|<0.001
72333941|NCT01559259|144191640|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.18||||0.616|TWO_SIDED|95.0|-0.87|0.52|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.52|-0.87|0.616
72333942|NCT01559259|144191640|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.57||||0.002|TWO_SIDED|95.0|0.57|2.56|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||2.56|0.57|0.002
72333943|NCT01559259|144191640|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.54||||0.002|TWO_SIDED|95.0|0.55|2.53|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||2.53|0.55|0.002
72333944|NCT01559259|144191640|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.95|||<|0.001|TWO_SIDED|95.0|0.95|2.94|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||2.94|0.95|<0.001
72333945|NCT01559259|144191640|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.91|||<|0.001|TWO_SIDED|95.0|0.92|2.9|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||2.90|0.92|<0.001
72333946|NCT01559259|144191640|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.34||||0.33|TWO_SIDED|95.0|-1.04|0.35|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.35|-1.04|0.330
72333947|NCT01559259|144191640|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.37||||0.288|TWO_SIDED|95.0|-1.06|0.32|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.32|-1.06|0.288
72333948|NCT01559259|144191640|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.04||||0.916|TWO_SIDED|95.0|-0.66|0.73|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.73|-0.66|0.916
72333949|NCT01559259|144191640|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.01||||0.041|TWO_SIDED|95.0|0.04|1.98|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.98|0.04|0.041
72333950|NCT01559259|144191640|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.05||||0.034|TWO_SIDED|95.0|0.08|2.01|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||2.01|0.08|0.034
72333951|NCT01559259|144191640|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.59||||0.001|TWO_SIDED|95.0|0.62|2.56|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||2.56|0.62|0.001
72333952|NCT01559259|144191640|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.48||||0.003|TWO_SIDED|95.0|0.52|2.45|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||2.45|0.52|0.003
72333953|NCT01559259|144191640|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.47||||0.171|TWO_SIDED|95.0|-1.15|0.2|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.20|-1.15|0.171
72333954|NCT01559259|144191640|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.44||||0.201|TWO_SIDED|95.0|-1.11|0.23|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.23|-1.11|0.201
72333955|NCT01559259|144191640|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.1||||0.763|TWO_SIDED|95.0|-0.57|0.78|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.78|-0.57|0.763
72333956|NCT01559259|144191640|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.66||||0.175|TWO_SIDED|95.0|-0.3|1.61|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.61|-0.30|0.175
72333957|NCT01559259|144191640|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.75||||0.12|TWO_SIDED|95.0|-0.2|1.7|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.70|-0.20|0.120
72424503|NCT01678820|144359923|SUPERIORITY_OR_OTHER||Difference in least squares means|2.9||||0.469|TWO_SIDED|95.0|-5.0|10.7|||Longitudinal Data Analysis Model|Based on a longitudinal model including terms for region, treatment, time, and the interaction of time by treatment.||||10.7|-5.0|0.469
72424504|NCT01678820|144359924|SUPERIORITY_OR_OTHER||Difference in least squares means|-24.4|||<|0.001|TWO_SIDED|95.0|-32.6|-16.3|||Longitudinal Data Analysis Model|Based on a longitudinal model including terms for region, treatment, time, and the interaction of time by treatment.||||-16.3|-32.6|<0.001
72424505|NCT01678820|144359924|SUPERIORITY_OR_OTHER||Difference in least squares means|0.3||||0.937|TWO_SIDED|95.0|-7.7|8.3|||Longitudinal Data Analysis Model|Based on a longitudinal model including terms for region, treatment, time, and the interaction of time by treatment.||||8.3|-7.7|0.937
72333958|NCT01559259|144191640|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.19||||0.014|TWO_SIDED|95.0|0.24|2.15|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||2.15|0.24|0.014
72333959|NCT01559259|144191640|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.31||||0.007|TWO_SIDED|95.0|0.36|2.26|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||2.26|0.36|0.007
72333960|NCT01559259|144191640|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.66||||0.054|TWO_SIDED|95.0|-1.32|0.01|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.01|-1.32|0.054
72333961|NCT01559259|144191640|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.56||||0.096|TWO_SIDED|95.0|-1.22|0.1|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.10|-1.22|0.096
72424506|NCT01678820|144359925|SUPERIORITY_OR_OTHER||Difference in estimated means|-15.5||||0.068|TWO_SIDED|95.0|-32.2|1.2|||Robust regression|Using M-estimation with treatment, region, and a covariate for baseline triglycerides (mg/dL). Missing data were imputed by multiple imputations.||||1.2|-32.2|0.068
72424507|NCT01678820|144359925|SUPERIORITY_OR_OTHER||Difference in estimated means|-10.3||||0.365|TWO_SIDED|95.0|-33.6|13.0|||Robust regression|Using M-estimation with treatment, region, and a covariate for baseline triglycerides (mg/dL). Missing data were imputed by multiple imputations.||||13.0|-33.6|0.365
72424508|NCT01678820|144359926|SUPERIORITY_OR_OTHER||Difference in least squares means|0.5||||0.857|TWO_SIDED|95.0|-4.8|5.8|||Longitudinal Data Analysis Model|Based on a longitudinal model including terms for region, treatment, time, and the interaction of time by treatment.||||5.8|-4.8|0.857
72424509|NCT01678820|144359926|SUPERIORITY_OR_OTHER||Difference in least squares means|0.4||||0.879|TWO_SIDED|95.0|-4.8|5.6|||Longitudinal Data Analysis Model|Based on a longitudinal model including terms for region, treatment, time, and the interaction of time by treatment.||||5.6|-4.8|0.879
72424510|NCT01678820|144359927|SUPERIORITY_OR_OTHER||Difference in least squares means|-30.4||||0.004|TWO_SIDED|95.0|-51.0|-9.7|||Longitudinal Data Analysis Model|Based on a longitudinal model including terms for region, treatment, time, and the interaction of time by treatment.||||-9.7|-51.0|0.004
72424511|NCT01678820|144359927|SUPERIORITY_OR_OTHER||Difference in least squares means|-15.3||||0.141|TWO_SIDED|95.0|-35.8|5.1|||Longitudinal Data Analysis Model|Based on a longitudinal model including terms for region, treatment, time, and the interaction of time by treatment.||||5.1|-35.8|0.141
72424512|NCT01678820|144359928|SUPERIORITY_OR_OTHER||Difference in percents|0.3|||||TWO_SIDED|95.0|-12.2|12.9|||||Based on Miettinen \& Nurminen method. Missing data were imputed by multiple impuattions.|||12.9|-12.2|
72424513|NCT01678820|144359928|SUPERIORITY_OR_OTHER||Difference in percents|12.3|||||TWO_SIDED|95.0|0.7|24.0|||||Based on Miettinen \& Nurminen method. Missing data were imputed by multiple imputations.|||24.0|0.7|
72333962|NCT01559259|144191640|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.12||||0.724|TWO_SIDED|95.0|-0.79|0.55|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.55|-0.79|0.724
72333963|NCT01559259|144191640|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.42||||0.345|TWO_SIDED|95.0|-0.46|1.3|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.30|-0.46|0.345
72424514|NCT03349268|144359936|SUPERIORITY|||||||0.23|||||||Poisson regression|||||||0.23
72424515|NCT02307513|144359960|SUPERIORITY||Difference in LS Mean|-92.6|||<|0.0001|TWO_SIDED|95.0|-130.59|-54.6|||ANCOVA|ANCOVA model with AUC W0-12 as the response variables; treatment arm, sex, region as factors and the number of oral ulcers at baseline as a covariate.|Treatment difference = Apremilast - Placebo|The AUC W0-12 for oral ulcer counts was compared between the placebo treatment group and the apremilast 30 BID treatment group using a 2-tailed parametric analysis of covariance (ANCOVA) test at the 0.05 significance level.||-54.60|-130.59|<0.0001
72424516|NCT02307513|144359961|SUPERIORITY||Difference in LS Mean|-24.8|||<|0.0001|TWO_SIDED|95.0|-32.8|-16.8|||ANCOVA|Based on an ANCOVA model for the change from baseline with the treatment arm, sex, region as factors and the baseline value as a covariate.||||-16.8|-32.8|<0.0001
72424517|NCT02307513|144359962|SUPERIORITY||Difference in LS Mean|-11.94|||<|0.0001|TWO_SIDED|95.0|-16.2|-7.67|||ANCOVA|Based on an ANCOVA model for the change from baseline with the treatment arm, sex, region as factors and the baseline value as a covariate.||||-7.67|-16.20|<0.0001
72424518|NCT02307513|144359963|SUPERIORITY||Difference in LS Means|-0.5||||0.0335|TWO_SIDED|95.0|-1.0|0.0|||ANCOVA|Based on an ANCOVA model for the change from baseline with the treatment arm, sex, region as factors and the baseline value as a covariate.||||-0.0|-1.0|0.0335
72424519|NCT02307513|144359964|SUPERIORITY||Difference in LS Means|-1.0|||<|0.0001|TWO_SIDED|95.0|-1.4|-0.6|||ANCOVA|Based on an ANCOVA model for the change from baseline with the treatment arm, sex, region as factors and the baseline value as a covariate.||||-0.6|-1.4|<0.0001
72424520|NCT02307513|144359965|SUPERIORITY||Difference in LS Means|-0.9|||<|0.0001|TWO_SIDED|95.0|-1.3|-0.5|||ANCOVA|Based on an ANCOVA model for the change from baseline with the treatment arm, sex, region as factors and the baseline value as a covariate.||||-0.5|-1.3|<0.0001
72424521|NCT02307513|144359966|SUPERIORITY||Adjusted difference in percentages|25.1|||<|0.0001|TWO_SIDED|95.0|15.5|34.6|||Cochran-Mantel-Haenszel|2 sided p-value based on the CMH test adjusting for sex and region.|Adjusted difference was the weighted average of the treatment differences across the 4 strata of combined sex and region factors with the CMH weights.|||34.6|15.5|<0.0001
72333964|NCT01559259|144191640|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.54||||0.228|TWO_SIDED|95.0|-0.34|1.41|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.41|-0.34|0.228
72333965|NCT01559259|144191640|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.9||||0.045|TWO_SIDED|95.0|0.02|1.78|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.78|0.02|0.045
72424522|NCT02307513|144359967|SUPERIORITY||Hazard Ratio (HR)|2.4|||<|0.0001|TWO_SIDED|95.0|1.692|3.405|||Stratified Log-Rank Test|Treatment comparison is based on the stratified log-rank test, with sex and region as the stratification factors.|The HR is based on the stratified Cox model with baseline number of oral ulcers and sex and region as the stratification factors.|||3.405|1.692|<0.0001
72333966|NCT01559259|144191640|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.08||||0.016|TWO_SIDED|95.0|0.21|1.96|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.96|0.21|0.016
72424523|NCT02307513|144359968|SUPERIORITY||Adjusted difference in percentages|30.6|||<|0.0001|TWO_SIDED|95.0|18.1|43.1|||Cochran-Mantel-Haenszel|2 sided p-value based on the CMH test adjusting for sex and region.|Adjusted difference was the weighted average of the treatment differences across the 4 strata of combined sex and region factors with the CMH weights.|||43.1|18.1|<0.0001
72424524|NCT02307513|144359969|SUPERIORITY||Difference in LS Mean|-3.0||||0.0003|TWO_SIDED|95.0|-4.5|-1.4|||ANCOVA|Based on an ANCOVA model for the change from baseline with the treatment arm, sex, region as factors and the baseline value as a covariate.||||-1.4|-4.5|0.0003
72333967|NCT01559259|144191640|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.66||||0.036|TWO_SIDED|95.0|-1.27|-0.04|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||-0.04|-1.27|0.036
72333968|NCT01559259|144191640|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.54||||0.081|TWO_SIDED|95.0|-1.15|0.07|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.07|-1.15|0.081
72333969|NCT01559259|144191640|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.18||||0.556|TWO_SIDED|95.0|-0.8|0.43|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.43|-0.80|0.556
72333970|NCT01559259|144191641|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|2.53|||<|0.001|TWO_SIDED|95.0|2.01|3.05||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-2 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||3.05|2.01|<0.001
72333971|NCT01559259|144191641|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.23|||<|0.001|TWO_SIDED|95.0|1.72|2.75||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-2 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||2.75|1.72|<0.001
72333972|NCT01559259|144191641|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.56|||<|0.001|TWO_SIDED|95.0|2.04|3.08||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-2 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||3.08|2.04|<0.001
72333973|NCT01559259|144191641|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.09|||<|0.001|TWO_SIDED|95.0|1.57|2.6||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-2 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||2.60|1.57|<0.001
72333974|NCT01559259|144191641|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.44||||0.016|TWO_SIDED|95.0|0.08|0.81||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-2 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||0.81|0.08|0.016
72424525|NCT02307513|144359970|SUPERIORITY||Adjusted difference in percentages|28.4||||0.11|TWO_SIDED|95.0|-3.6|60.4|||Cochran-Mantel-Haenszel|2 sided p-value based on the CMH test adjusting for sex.|Adjusted difference was the weighted average of the treatment differences across the 2 strata of sex with the CMH weights.|||60.4|-3.6|0.1100
72424526|NCT02307513|144359971|SUPERIORITY||Adjusted difference in percentages|17.5||||0.0204|TWO_SIDED|95.0|4.2|30.7|||Cochran-Mantel-Haenszel|Two-sided p-value was based on the CMH test, adjusting for sex and region.|Adjusted difference was the weighted average of the treatment differences across the 4 strata of combined sex and region factors with the CMH weights.|||30.7|4.2|0.0204
72424527|NCT02307513|144359972|SUPERIORITY||Hazard Ratio (HR)|0.611||||0.0112|TWO_SIDED|95.0|0.408|0.915|||Stratified Log Rank Test|Treatment comparison is based on the stratified log-rank test, with sex and region as the stratification factors.|The HR is based on the stratified Cox model with baseline number of oral ulcers and sex and region as the stratification factors|||0.915|0.408|0.0112
72424528|NCT02307513|144359973|SUPERIORITY||Difference in LS Means|-0.4||||0.0683|TWO_SIDED|95.0|-0.9|0.0|||ANCOVA|ANCOVA model with treatment group, sex and region as factors and the baseline ulcers number as a covariate.||||0.0|-0.9|0.0683
72424529|NCT02307513|144359974|SUPERIORITY||Difference in LS Mean|-0.1||||0.5944|TWO_SIDED|95.0|-0.4|0.3|||ANCOVA|Based on an ANCOVA model for the change from baseline, with treatment arm, sex and region as factors and the baseline score as a covariate.||||0.3|-0.4|0.5944
72424530|NCT02307513|144359975|SUPERIORITY||Difference in LS Mean|-5.5||||0.6182|TWO_SIDED|95.0|-27.6|16.7|||ANCOVA|Based on an ANCOVA model for the change from baseline, with treatment arm, sex and region as factors and the baseline score as a covariate.||||16.7|-27.6|0.6182
72424531|NCT00744263|144359978|SUPERIORITY_OR_OTHER||Vaccine Efficacy|45.56||||0.0006|TWO_SIDED|95.2|21.82|62.49|||Clopper-Pearson method|||Vaccine efficacy against first event expressed as percentage. Vaccine efficacy = 1 - (proportion of participants who received 13vPnC with confirmed VT-CAP relative to those who received placebo). p-value and confidence intervals were derived using Clopper-Pearson method. The null hypothesis was vaccine efficacy = 0.||62.49|21.82|0.0006
72424532|NCT00744263|144359979|SUPERIORITY_OR_OTHER||Vaccine Efficacy|45.0||||0.0067|TWO_SIDED|95.2|14.21|65.31|||Clopper-Pearson method|||Vaccine efficacy against first event expressed as percentage. Vaccine efficacy = 1-(proportion of participants who received 13vPnC with confirmed VT-CAP relative to those who received placebo). p-value and confidence intervals were derived using Clopper-Pearson method. The null hypothesis was vaccine efficacy = 0.||65.31|14.21|0.0067
72424533|NCT00744263|144359980|SUPERIORITY_OR_OTHER||Vaccine Efficacy|75.0||||0.0005|TWO_SIDED|95.0|41.43|90.78|||Clopper-Pearson method|||Vaccine efficacy against first event expressed as percentage. Vaccine efficacy = 1-(proportion of participants who received 13vPnC with confirmed VT-CAP relative to those who received placebo). p-value and confidence intervals were derived using Clopper-Pearson method. The null hypothesis was vaccine efficacy = 0.||90.78|41.43|0.0005
72424534|NCT00744263|144359983|SUPERIORITY_OR_OTHER|||||||0.979|TWO_SIDED||||||Fisher Exact|||Fisher exact test, 2-sided, was used to calculate the p-value for the difference between vaccine groups in percentages of participants.||||0.979
72424535|NCT00744263|144359984|SUPERIORITY_OR_OTHER|||||||0.455|TWO_SIDED||||||Fisher Exact|||Fisher exact test, 2-sided, was used to calculate the p-value for the difference between vaccine groups in percentages of participants.||||0.455
72424536|NCT01121172|144359991|SUPERIORITY_OR_OTHER|||||||0.001|||||||Wilcoxon (Mann-Whitney)|Non parametric test||||||0.001
72333975|NCT01559259|144191641|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.14||||0.428|TWO_SIDED|95.0|-0.21|0.5||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-2 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||0.50|-0.21|0.428
72424537|NCT01121172|144359992|SUPERIORITY_OR_OTHER|||||||0.232|||||||Chi-squared|Chi-square test of frequency distribution amng obese study group and HapMap-CEU polymorphism distribution||||||0.232
72424538|NCT02541383|144360017|SUPERIORITY||Odds Ratio (OR)|1.6||||0.001|TWO_SIDED|95.0|1.21|2.12|||Cochran-Mantel-Haenszel|||||2.12|1.21|0.0010
72424539|NCT02541383|144360018|SUPERIORITY||Hazard Ratio (HR)|0.53|||<|0.0001|TWO_SIDED|95.0|0.42|0.68|||Log Rank|||||0.68|0.42|<0.0001
72424540|NCT02541383|144360019|SUPERIORITY||Hazard Ratio (HR)|0.61|||<|0.0001|TWO_SIDED|95.0|0.52|0.72|||Log Rank|||||0.72|0.52|<0.0001
72424541|NCT00405639|144360026|SUPERIORITY_OR_OTHER||||||<|0.01|||||||t-test, 2 sided|||||||<0.01
72424542|NCT00405639|144360027|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||t-test, 2 sided|||||||<0.05
72424543|NCT00405639|144360028|SUPERIORITY_OR_OTHER|||||||0.07||95.0|||||t-test, 2 sided|||||||0.07
72424544|NCT00405639|144360029|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||t-test, 2 sided|||||||<0.05
72424545|NCT01087996|144360052|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|||||||1.00
72424546|NCT01087996|144360053|SUPERIORITY_OR_OTHER|||||||0.75||95.0|||||ANOVA|||||||0.75
72424547|NCT01087996|144360054|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||ANOVA|||||||>0.05
72424548|NCT01087996|144360055|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||ANOVA|||||||>0.05
72424549|NCT01087996|144360056|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||ANOVA|||||||>0.05
72424550|NCT01087996|144360057|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||ANOVA|||||||>0.05
72424551|NCT01087996|144360058|SUPERIORITY_OR_OTHER|||||||0.87||95.0|||||Repeated measures ANOVA|||||||0.87
72424552|NCT01087996|144360059|SUPERIORITY_OR_OTHER|||||||0.84||95.0|||||Repeated measures ANOVA|||||||0.84
72424553|NCT01087996|144360060|SUPERIORITY_OR_OTHER|||||||0.55||95.0|||||Chi-squared|||||||0.55
72424554|NCT02066896|144360070|OTHER|ANOVA repeated measures||||||0.05|||||||ANOVA|ANOVA repeated measures||||||0.05
72424555|NCT05067933|144360087|OTHER|Comparison between immunogenicity assay results between treatment groups on Day 57.||||||0.953|||||||Wilcoxon rank sum tests|||||||0.953
72424556|NCT05067933|144360088|OTHER|Comparison between immunogenicity assay results between treatment groups on Day 57.||||||0.5|||||||Wilcoxon rank sum tests|||||||0.500
72424557|NCT05067933|144360089|OTHER|Comparison between immunogenicity assay results between treatment groups on Day 57.||||||0.912|||||||Wilcoxon rank sum tests|||||||0.912
72424558|NCT05067933|144360090|OTHER|Comparison between immunogenicity assay results between treatment groups on Day 57.||||||0.678|||||||Wilcoxon rank sum tests|||||||0.678
72424559|NCT05067933|144360091|OTHER|Comparison between immunogenicity assay results between treatment groups on Day 57.||||||0.257|||||||Wilcoxon rank sum tests|||||||0.257
72424560|NCT05067933|144360092|OTHER|Comparison between immunogenicity assay results between treatment groups on Day 57.||||||0.748|||||||Wilcoxon rank sum tests|||||||0.748
72424561|NCT05067933|144360093|OTHER|Comparison between immunogenicity assay results between treatment groups on Day 57.||||||0.946|||||||Wilcoxon rank sum tests|||||||0.946
72424562|NCT05067933|144360096|OTHER|Comparison between immunogenicity assay results between treatment groups on Day 57.||||||0.356|||||||Wilcoxon rank sum tests|||||||0.356
72424563|NCT05067933|144360097|OTHER|Comparison between immunogenicity assay results between treatment groups on Day 57.||||||0.267|||||||Wilcoxon rank sum tests|||||||0.267
72424564|NCT01065350|144360115|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.87|||<|0.001|TWO_SIDED|95.0|2.07|26.15||A p value of \< 0.05 was considered to indicate statistical significance.|Chi-squared|||Systolic Blood Pressure (SBP) from baseline to 5 minutes post induction was compared between treatment groups.||26.15|2.07|<0.001
72424565|NCT01065350|144360115|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.24|||<|0.01|TWO_SIDED|95.0|1.21|8.75||A p value of \< 0.05 was considered to indicate statistical significance.|Chi-squared|||Systolic Blood Pressure (SBP) from baseline to 10 minutes post induction was compared between treatment groups.||8.75|1.21|<0.01
72424566|NCT01065350|144360115|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.53||||0.39|TWO_SIDED|95.0|0.52|4.55||A p value of \< 0.005 was considered to indicate statistical significance.|Chi-squared|||Systolic Blood Pressure (SBP) from baseline to 30 minutes post induction was compared between treatment groups||4.55|0.52|0.39
72424567|NCT01065350|144360116|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.64|||<|0.01|TWO_SIDED|95.0|1.54|14.92||A p value of \< 0.05 was considered to indicate statistical significance.|Chi-squared|||Diastolic Blood Pressure (DBP) from baseline to 5 minutes post induction was compared between treatment groups.||14.92|1.54|<0.01
72424568|NCT01065350|144360116|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.38||||0.05|TWO_SIDED|95.0|0.91|6.29||A p value of \< 0.05 was considered to indicate statistical significance.|Chi-squared|||Diastolic Blood Pressure (DBP) from baseline to 10 minutes post induction was compared between treatment groups.||6.29|0.91|0.05
72424569|NCT01065350|144360116|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.74||||0.11|TWO_SIDED|95.0|0.68|13.19||A p value of \< 0.05 was considered to indicate statistical significance.|Chi-squared|||Diastolic Blood Pressure (DBP) from baseline to 30 minutes post induction was compared between treatment groups.||13.19|0.68|0.11
72424570|NCT01065350|144360117|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|7.12|||<|0.001|TWO_SIDED|95.0|1.98|31.64||A p value of \< 0.05 was considered to indicate statistical significance.|Chi-squared|||Mean Arterial Pressure (MAP) from baseline to 5 minutes post induction was compared between treatment groups.||31.64|1.98|<0.001
72424571|NCT01065350|144360117|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.84||||0.02|TWO_SIDED|95.0|1.07|7.65||A p value of \< 0.05 was considered to indicate statistical significance.|Chi-squared|||Mean Arterial Pressure (MAP) from baseline to 10 minutes post induction was compared between treatment groups.||7.65|1.07|0.02
72424572|NCT01065350|144360117|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.71||||0.33|TWO_SIDED|95.0|0.51|5.97||A p value of \< 0.05 was considered to indicate statistical significance.|Chi-squared|||Mean Arterial Pressure (MAP) from baseline to 30 minutes post induction was compared between treatment groups.||5.97|0.51|0.33
72424573|NCT01065350|144360118|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2||||0.19|TWO_SIDED|95.0|-0.1|0.5|||t-test, 2 sided|||Average change in Cardiac Output (CO) from baseline to 5 minutes post induction was compared between treatment groups.||0.5|-0.1|0.19
72424574|NCT01065350|144360118|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||0.6|TWO_SIDED|95.0|-0.3|0.5|||t-test, 2 sided|||Average change in Cardiac Output (CO) from baseline to 10 minutes post induction was compared between treatment groups.||0.5|-0.3|0.6
72424575|NCT01065350|144360119|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||0.26|TWO_SIDED|95.0|-0.1|0.3|||t-test, 2 sided|||Average change in Cardiac Index (CI) from baseline to 5 minutes post induction was compared between treatment groups.||0.3|-0.1|0.26
72424576|NCT01065350|144360119|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.71|TWO_SIDED|95.0|-0.2|0.3|||t-test, 2 sided|||Average change in Cardiac Index (CI) from baseline to 10 minutes post induction was compared between treatment groups.||0.3|-0.2|0.71
72424577|NCT01065350|144360120|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6||||0.61|TWO_SIDED|95.0|-2.9|1.7|||t-test, 2 sided|||Average heart rate from baseline to 5 minutes post induction was compared between treatment groups.||1.7|-2.9|0.61
72424578|NCT01065350|144360120|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.8||||0.22|TWO_SIDED|95.0|-4.8|1.1|||t-test, 2 sided|||Average heart rate from baseline to 10 minutes post induction was compared between treatment groups.||1.1|-4.8|0.22
72424579|NCT01065350|144360121|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.7|||<|0.001|TWO_SIDED|95.0|7.5|20.0|||t-test, 2 sided|||Average change in Systolic Blood Pressure from baseline to 5 minutes post induction was compared between treatment groups.||20.0|7.5|<0.001
72424580|NCT01065350|144360121|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.8||||0.017|TWO_SIDED|95.0|0.2|9.5|||t-test, 2 sided|||Average change in Systolic Blood Pressure from baseline to 10 minutes post induction was compared between treatment groups.||9.5|0.2|0.017
72424581|NCT01065350|144360122|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.1|||<|0.01|TWO_SIDED|95.0|2.7|11.5|||t-test, 2 sided|||Average change in Diastolic Blood Pressure from baseline to 5 minutes post induction was compared between treatment groups.||11.5|2.7|<0.01
72424582|NCT01065350|144360122|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.8||||0.042|TWO_SIDED|95.0|0.2|9.5|||t-test, 2 sided|||Average change in Diastolic Blood Pressure from baseline to 10 minutes post induction was compared between treatment groups.||9.5|0.2|0.042
72333976|NCT01559259|144191641|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.47||||0.01|TWO_SIDED|95.0|0.11|0.84||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-2 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||0.84|0.11|0.010
72424583|NCT01065350|144360123|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.4|||<|0.001|TWO_SIDED|95.0|4.8|13.9|||t-test, 2 sided|||Average change in Mean Arterial Pressure (MAP) from baseline to 5 minutes post induction was compared between treatment groups.||13.9|4.8|<0.001
72424584|NCT01065350|144360123|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.3||||0.013|TWO_SIDED|95.0|1.4|11.3|||t-test, 2 sided|||Average change in Mean Arterial Pressure from baseline to 10 minutes post induction was compared between treatment groups.||11.3|1.4|0.013
72424585|NCT01065350|144360124|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|113.6|||<|0.01|TWO_SIDED|95.0|28.1|199.1|||t-test, 2 sided|||Average change in Total Peripheral Resistance (TPR) from baseline to 5 minutes post induction was compared between treatment groups.||199.1|28.1|<0.01
72424586|NCT01065350|144360124|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|86.8||||0.12|TWO_SIDED|95.0|-21.7|195.3|||t-test, 2 sided|||Average change in Total Peripheral Resistance (TPR) from baseline to 10 minutes post induction was compared between treatment groups.||195.3|-21.7|0.12
72424587|NCT01065350|144360125|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|182.6||||0.017|TWO_SIDED|95.0|33.8|331.3|||t-test, 2 sided|||Average change in Total Peripheral Resistance Index (TPRI) from baseline to 5 minutes post induction was compared between treatment groups.||331.3|33.8|0.017
72424588|NCT01065350|144360125|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|128.7||||0.17|TWO_SIDED|95.0|-58.1|315.5|||t-test, 2 sided|||Average change in Total Peripheral Resistance Index (TPRI) from baseline to 10 minutes post induction was compared between treatment groups.||315.5|-58.1|0.17
72424589|NCT01065350|144360126|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.4||||0.029|TWO_SIDED|95.0|0.5|8.4|||t-test, 2 sided|||Average change in Stroke Volume (SV) from baseline to 5 minutes post induction was compared between treatment groups.||8.4|0.5|0.029
72424590|NCT01065350|144360126|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.8||||0.051|TWO_SIDED|95.0|0.0|9.7|||t-test, 2 sided|||Average change in Cardiac Index (CI) from baseline to 10 minutes post induction was compared between treatment groups.||9.7|-0.0|0.051
72424591|NCT01065350|144360127|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.5||||0.027|TWO_SIDED|95.0|0.3|4.7|||t-test, 2 sided|||Average change in Stroke Volume Index (SVI) from baseline to 5 minutes post induction was compared between treatment groups.||4.7|0.3|0.027
72424592|NCT01065350|144360127|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.6||||0.052|TWO_SIDED|95.0|0.0|5.2|||t-test, 2 sided|||Average change in Stroke Volume Index (SVI) from baseline to 10 minutes post induction was compared between treatment groups.||5.2|-0.0|0.052
72424593|NCT01065350|144360128|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4||||0.44|TWO_SIDED|95.0|-1.4|0.6|||t-test, 2 sided|||Average change in Stroke Volume Variation (SVV) from baseline to 5 minutes post induction was compared between treatment groups.||0.6|-1.4|0.44
72424594|NCT01065350|144360128|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5||||0.37|TWO_SIDED|95.0|-1.6|0.6|||t-test, 2 sided|||Average change in Stroke Volume Variation (SVV) from baseline to 10 minutes post induction was compared between treatment groups.||0.6|-1.6|0.37
72424595|NCT05879198|144360141|SUPERIORITY|||||||0.473|||||||t-test, 1 sided|||Paired samples, one-sided t-test comparing changes in total scale scores.||||.473
72424596|NCT05879198|144360142|SUPERIORITY|||||||0.469|||||||t-test, 1 sided|||Paired samples, one-sided t-test comparing changes in total scale scores.||||.469
72424597|NCT05879198|144360143|SUPERIORITY|||||||0.155|||||||t-test, 1 sided|||Paired samples, one-sided t-test comparing changes in total scale scores.||||.155
72424598|NCT05879198|144360144|SUPERIORITY|||||||0.346|||||||t-test, 1 sided|||Paired samples, one-sided t-test comparing changes in total scale scores.||||.346
72424599|NCT05879198|144360146|SUPERIORITY|||||||0.075|||||||t-test, 1 sided|||Paired samples, one-sided t-test comparing changes in AEQ-positive scale scores.||||.075
72424600|NCT05879198|144360146|SUPERIORITY|||||||0.32|||||||t-test, 1 sided|||Paired samples, one-sided t-test comparing changes in AEQ-negative scale scores.||||.320
72424601|NCT05879198|144360146|SUPERIORITY|||||||0.049|||||||t-test, 1 sided|||Paired samples, one-sided t-test comparing changes in MEEQ-positive scale scores.||||.049
72424602|NCT05879198|144360146|SUPERIORITY|||||||0.089|||||||t-test, 1 sided|||Paired samples, one-sided t-test comparing changes in MEEQ-negative scale scores.||||.089
72424603|NCT00663117|144360147|SUPERIORITY_OR_OTHER|||||||0.009||||||The percentage of subjects achieving a 70-point drop in CDAI score in naltrexone treated subjects was the percentage acheiving the same drop in the placebo controls|Fisher Exact|||The proportion of those achieving a response with a 70-point decline in CDAI score was compared between naltrexone and placebo treated subjects using the Fisher's exact test. Analysis was performed with the intent-to-treat criteria. Clinical significance was accepted if the difference met 95% confidence (p\<0.05).||||0.009
72424604|NCT00663117|144360149|SUPERIORITY_OR_OTHER|||||||0.008|ONE_SIDED|95.0|||||Fisher Exact|||Percentage of patients having a 5-point decline in the endoscopic inflammation score||||0.008
72424605|NCT00663117|144360150|SUPERIORITY_OR_OTHER|||||||0.048||95.0|||||t-test, 1 sided|||||||0.048
72424606|NCT02019563|144360164|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.34||||0.15|TWO_SIDED|95.0|0.08|1.49|||Chi-squared|||Radiographic outcomes were compared using univariate repeated measures logistic regression. A binary logistic generalized estimating equation model was used to analyze predictor variables such as age, gender, tooth and treatment provider between the treatment groups.||1.49|.08|.15
72424607|NCT02019563|144360165|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.6||||0.38|TWO_SIDED|95.0|0.19|1.89|||Chi-squared|||Radiographic outcomes were compared using univariate repeated measures logistic regression. A binary logistic generalized estimating equation model was used to analyze predictor variables such as age, gender, tooth and treatment provider between the treatment groups.||1.89|.19|.38
72424608|NCT02019563|144360166|SUPERIORITY_OR_OTHER|||||||0.51|TWO_SIDED||||||Fisher Exact|||A binary logistic generalized estimating equation (GEE) model was used to analyze predictor variables such as age, gender, tooth and treatment provider between the treatment groups for radiographic and clinical outcomes.||||.51
72424609|NCT02019563|144360167|SUPERIORITY_OR_OTHER|||||||0.64|TWO_SIDED||||||Fisher Exact|||A binary logistic generalized estimating equation (GEE) model was used to analyze predictor variables such as age, gender, tooth and treatment provider between the treatment groups for radiographic and clinical outcomes.||||.64
72424610|NCT02019563|144360168|SUPERIORITY_OR_OTHER|||||||0.11|TWO_SIDED|||||The p-value represents the survival rate from the Kaplan-Meier survival analysis from 6 to 36 months.|Log Rank|||||||.11
72424611|NCT03285295|144360184|SUPERIORITY||Clinical Specificity (%)|99.96|||||TWO_SIDED|95.0|99.92|99.99|||Binomial Distribution|Specificity sample size is a minimum of 15,000 donors.||||99.99|99.92|
72424612|NCT03285295|144360185|OTHER|95% Confidence Interval provided.|Point Estimate|100.0|||||TWO_SIDED|95.0|99.15|100.0|||Sensitivity|||||100.00|99.15|
72424613|NCT03285295|144360186|SUPERIORITY||Clinical Specificity (%)|99.99|||||TWO_SIDED|95.0|99.95|100.0|||Binomial Distribution|||||100.00|99.95|
72424614|NCT03285295|144360187|OTHER|95% Confidence Interval provided.|Point Estimate|100.0|||||TWO_SIDED|95.0|99.48|100.0|||Sensitivity|||||100.00|99.48|
72424615|NCT03285295|144360188|SUPERIORITY||Clinical Specificity (%)|99.92|||||TWO_SIDED|95.0|99.86|99.95|||Binomial Distribution|||||99.95|99.86|
72424616|NCT03285295|144360189|OTHER|95% Confidence Interval provided.|Point Estimate|100.0|||||TWO_SIDED|95.0|99.09|100.0|||Sensitivity|||||100.00|99.09|
72333977|NCT01559259|144191641|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|8.38|||<|0.001|TWO_SIDED|95.0|6.59|10.18||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-6 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||10.18|6.59|<0.001
72333978|NCT01559259|144191641|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|7.68|||<|0.001|TWO_SIDED|95.0|5.89|9.47||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-6 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||9.47|5.89|<0.001
72424617|NCT03285295|144360190|SUPERIORITY||Clinical Specificity (%)|99.92|||||TWO_SIDED|95.0|99.87|99.96|||Binomial Exact|||||99.96|99.87|
72424618|NCT03285295|144360191|OTHER|95% Confidence Interval provided.|Point Estimate|100.0|||||TWO_SIDED|95.0|99.72|100.0|||Sensitivity|||||100.00|99.72|
72333979|NCT01559259|144191641|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|8.7|||<|0.001|TWO_SIDED|95.0|6.91|10.5||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-6 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||10.50|6.91|<0.001
72424619|NCT03285295|144360192|SUPERIORITY||Clinical Specificity (%)|99.9|||||TWO_SIDED|95.0|99.84|99.94|||Binomial Exact|||||99.94|99.84|
72424620|NCT03285295|144360193|OTHER|95% Confidence Interval provided.|Point Estimate|100.0|||||TWO_SIDED|95.0|99.09|100.0|||Sensitivity|||||100.00|99.09|
72333980|NCT01559259|144191641|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|7.65|||<|0.001|TWO_SIDED|95.0|5.86|9.44||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-6 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||9.44|5.86|<0.001
72333981|NCT01559259|144191641|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.74||||0.25|TWO_SIDED|95.0|-0.52|1.99||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-6 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||1.99|-0.52|0.250
72333982|NCT01559259|144191641|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.04||||0.956|TWO_SIDED|95.0|-1.21|1.28||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-6 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||1.28|-1.21|0.956
72333983|NCT01559259|144191641|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.06||||0.099|TWO_SIDED|95.0|-0.2|2.31||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-6 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||2.31|-0.20|0.099
72333984|NCT01559259|144191641|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|10.22|||<|0.001|TWO_SIDED|95.0|7.78|12.66||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-8 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||12.66|7.78|<0.001
72333985|NCT01559259|144191641|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|9.49|||<|0.001|TWO_SIDED|95.0|7.06|11.92||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-8 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||11.92|7.06|<0.001
72333986|NCT01559259|144191641|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|10.72|||<|0.001|TWO_SIDED|95.0|8.28|13.15||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-8 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||13.15|8.28|<0.001
72424621|NCT03285295|144360194|SUPERIORITY||Clinical Specificity (%)|99.98|||||TWO_SIDED|95.0|99.94|100.0|||Binomial Exact|||||100.00|99.94|
72333987|NCT01559259|144191641|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|9.63|||<|0.001|TWO_SIDED|95.0|7.19|12.06||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-8 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||12.06|7.19|<0.001
72424622|NCT03285295|144360195|OTHER|95% Confidence Interval provided.|Point Estimate|100.0|||||TWO_SIDED|95.0|98.85|100.0|||Sensitivity|||||100.00|98.85|
72424623|NCT03285295|144360200|OTHER|95% Confidence Interval provided.|Point Estimate|100.0|||||TWO_SIDED|95.0|95.98|100.0|||Sensitivity|||Sensitivity||100.00|95.98|
72424624|NCT03285295|144360202|OTHER|95% Confidence Interval provided.|Point Estimate|100.0|||||TWO_SIDED|95.0|92.75|100.0|||Sensitivity|||Sensitivity||100.00|92.75|
72424625|NCT03285295|144360203|OTHER|95% Confidence Interval provided.|Point Estimate|100.0|||||TWO_SIDED|95.0|94.87|100.0|||Sensitivity|||Sensitivity||100.00|94.87|
72424626|NCT03285295|144360204|OTHER|95% Confidence Interval provided.|Point Estimate|98.65|||||TWO_SIDED|95.0|95.2|99.84|||Sensitivity|||Sensitivity||99.84|95.20|
72424627|NCT01015807|144360205|OTHER|||||||0.48|||||||ANOVA|||We estimated that 25 subjects per group would allow us to detect a reduction of this area from 7.5 cm2 in our placebo group to 3.5 cm2 in the CloTAP group, with SD = 5 cm2 in both groups, owing to improved overall analgesia and reduced pain sensitization in women allocated to receive a TAP block with clonidine (2-tailed \[alpha\] = 0.05, 80% power). To allow for failed TAP blocks and/or exclusions of cases, we included 30 patients per group (n = 90)||||0.48
72424628|NCT01872910|144360301|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|9.0|||||TWO_SIDED|95.0|-2.1|20.0|||||95% CrI is reported here, not the CI.|||20.0|-2.1|
72424629|NCT01872910|144360301|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-34.6|||||TWO_SIDED|95.0|-45.7|-23.2|||||95% CrI is reported here, not the CI.|||-23.2|-45.7|
72424630|NCT01872910|144360301|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|43.6|||||TWO_SIDED|95.0|32.7|54.9|||||95% CrI is reported here, not the CI.|||54.9|32.7|
72424631|NCT01872910|144360302|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.3|||||TWO_SIDED|95.0|-2.9|0.2|||||95% CrI is reported here, not the CI. Estimation is for TOPAR 0 to 4 h.|||0.2|-2.9|
72424632|NCT01872910|144360302|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.5|||||TWO_SIDED|95.0|2.9|6.0|||||95% CrI is reported here, not the CI. Estimation is for TOPAR 0 to 4 h.|||6.0|2.9|
72333988|NCT01559259|144191641|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.6||||0.492|TWO_SIDED|95.0|-1.11|2.3||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-8 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||2.30|-1.11|0.492
72333989|NCT01559259|144191641|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.14||||0.873|TWO_SIDED|95.0|-1.83|1.56||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-8 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||1.56|-1.83|0.873
72333990|NCT01559259|144191641|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.09||||0.21|TWO_SIDED|95.0|-0.62|2.79||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-8 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||2.79|-0.62|0.210
72424633|NCT01872910|144360302|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.9|||||TWO_SIDED|95.0|-7.4|-4.3|||||95% CrI is reported here, not the CI. Estimation is for TOPAR 0 to 4 h.|||-4.3|-7.4|
72333991|NCT01559259|144191641|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|11.65|||<|0.001|TWO_SIDED|95.0|8.1|15.2||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-12 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||15.20|8.10|<0.001
72424634|NCT01872910|144360302|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.5|||||TWO_SIDED|95.0|-5.2|0.2|||||95% CrI is reported here, not the CI. Estimation is for TOPAR 0 to 6 h.|||0.2|-5.2|
72424635|NCT01872910|144360302|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|7.1|||||TWO_SIDED|95.0|4.4|9.8|||||95% CrI is reported here, not the CI. Estimation is for TOPAR 0 to 6 h.|||9.8|4.4|
72424636|NCT01872910|144360302|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-9.6|||||TWO_SIDED|95.0|-12.2|-6.9|||||95% CrI is reported here, not the CI. Estimation is for TOPAR 0 to 6 h.|||-6.9|-12.2|
72424637|NCT01872910|144360302|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.0|||||TWO_SIDED|95.0|-7.9|-0.1|||||95% CrI is reported here, not the CI. Estimation is for TOPAR 0 to 8 h.|||-0.1|-7.9|
72424638|NCT01872910|144360302|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|9.2|||||TWO_SIDED|95.0|5.3|13.0|||||95% CrI is reported here, not the CI. Estimation is for TOPAR 0 to 8 h.|||13.0|5.3|
72333992|NCT01559259|144191641|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|10.94|||<|0.001|TWO_SIDED|95.0|7.4|14.48||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-12 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||14.48|7.40|<0.001
72333993|NCT01559259|144191641|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|12.65|||<|0.001|TWO_SIDED|95.0|9.1|16.2||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-12 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||16.20|9.10|<0.001
72333994|NCT01559259|144191641|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|11.72|||<|0.001|TWO_SIDED|95.0|8.18|15.26||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-12 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||15.26|8.18|<0.001
72333995|NCT01559259|144191641|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.07||||0.957|TWO_SIDED|95.0|-2.55|2.42||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-12 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||2.42|-2.55|0.957
72424639|NCT01872910|144360302|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-13.1|||||TWO_SIDED|95.0|-16.9|-9.3|||||95% CrI is reported here, not the CI. Estimation is for TOPAR 0 to 8 h.|||-9.3|-16.9|
72333996|NCT01559259|144191641|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.78||||0.534|TWO_SIDED|95.0|-3.25|1.69||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-12 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||1.69|-3.25|0.534
72424640|NCT01872910|144360302|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.8|||||TWO_SIDED|95.0|-13.2|0.5|||||95% CrI is reported here, not the CI. Estimation is for TOPAR 0 to 12 h.|||0.5|-13.2|
72424641|NCT01872910|144360302|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|12.9|||||TWO_SIDED|95.0|6.6|19.2|||||95% CrI is reported here, not the CI. Estimation is for TOPAR 0 to 12 h.|||19.2|6.6|
72424642|NCT01872910|144360302|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-19.7|||||TWO_SIDED|95.0|-25.9|-13.5|||||95% CrI is reported here, not the CI. Estimation is for TOPAR 0 to 12 h.|||-13.5|-25.9|
72424643|NCT01872910|144360302|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-16.3|||||TWO_SIDED|95.0|-30.8|-2.0|||||95% CrI is reported here, not the CI. Estimation is for TOPAR 0 to 24 h.|||-2.0|-30.8|
72424644|NCT01872910|144360302|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|23.1|||||TWO_SIDED|95.0|9.0|37.2|||||95% CrI is reported here, not the CI. Estimation is for TOPAR 0 to 24 h.|||37.2|9.0|
72424645|NCT01872910|144360302|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-39.4|||||TWO_SIDED|95.0|-53.2|-25.3|||||95% CrI is reported here, not the CI. Estimation is for TOPAR 0 to 24 h.|||-25.3|-53.2|
72424646|NCT01872910|144360302|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0|||||TWO_SIDED|95.0|-1.5|1.6|||||95% CrI is reported here, not the CI. Estimation is for TOPAR 0 to 4 h.|||1.6|-1.5|
72424647|NCT01872910|144360302|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.3|||||TWO_SIDED|95.0|-2.9|2.4|||||95% CrI is reported here, not the CI. Estimation is for TOPAR 0 to 6 h.|||2.4|-2.9|
72333997|NCT01559259|144191641|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.93||||0.462|TWO_SIDED|95.0|-1.55|3.41||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-12 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||3.41|-1.55|0.462
72333998|NCT01559259|144191642|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|9.06|||<|0.001|TWO_SIDED|95.0|7.23|10.89||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR, baseline numerical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-2 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||10.89|7.23|<0.001
72333999|NCT01559259|144191642|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|8.14|||<|0.001|TWO_SIDED|95.0|6.33|9.95||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR, baseline numerical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-2 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||9.95|6.33|<0.001
72334000|NCT01559259|144191642|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|8.66|||<|0.001|TWO_SIDED|95.0|6.83|10.49||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR, baseline numerical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-2 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||10.49|6.83|<0.001
72334001|NCT01559259|144191642|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|7.61|||<|0.001|TWO_SIDED|95.0|5.78|9.44||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR, baseline numerical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-2 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||9.44|5.78|<0.001
72334002|NCT01559259|144191642|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.45||||0.024|TWO_SIDED|95.0|0.19|2.7||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR, baseline numerical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-2 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||2.70|0.19|0.024
72334003|NCT01559259|144191642|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.53||||0.392|TWO_SIDED|95.0|-0.69|1.76||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR, baseline numerical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-2 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||1.76|-0.69|0.392
72334004|NCT01559259|144191642|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.05||||0.101|TWO_SIDED|95.0|-0.21|2.3||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR, baseline numerical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-2 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||2.30|-0.21|0.101
72334005|NCT01559259|144191642|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|30.23|||<|0.001|TWO_SIDED|95.0|23.97|36.48||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR, baseline numerical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-6 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||36.48|23.97|<0.001
72334006|NCT01559259|144191642|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|27.93|||<|0.001|TWO_SIDED|95.0|21.74|34.11||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR, baseline numerical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-6 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||34.11|21.74|<0.001
72334007|NCT01559259|144191642|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|29.86|||<|0.001|TWO_SIDED|95.0|23.6|36.12||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR, baseline numerical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-6 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||36.12|23.60|<0.001
72334008|NCT01559259|144191642|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|27.59|||<|0.001|TWO_SIDED|95.0|21.33|33.86||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR, baseline numerical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-6 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||33.86|21.33|<0.001
72424648|NCT01872910|144360302|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.8|||||TWO_SIDED|95.0|-4.7|3.1|||||95% CrI is reported here, not the CI. Estimation is for TOPAR 0 to 8 h.|||3.1|-4.7|
72334009|NCT01559259|144191642|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.63||||0.228|TWO_SIDED|95.0|-1.65|6.92||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR, baseline numerical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-6 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||6.92|-1.65|0.228
72334010|NCT01559259|144191642|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.33||||0.875|TWO_SIDED|95.0|-3.84|4.51||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR, baseline numerical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-6 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||4.51|-3.84|0.875
72334011|NCT01559259|144191642|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.27||||0.299|TWO_SIDED|95.0|-2.02|6.55||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR, baseline numerical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-6 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||6.55|-2.02|0.299
72369431|NCT03894813|144248841|NON_INFERIORITY|The relevant parameters were determined as follows: test level α=0.05, test power 1-β=0.80, Pt=0.90, Pc=0.75, Nt:Nc=1:1, boundary value Δ= -0.0.068 (excellent), and Fisher's exact test. As a result, the sample size of each group was calculated as 50 patients, 100 patients in total. Considering a loss to follow-up rate of 20%, a sample size of 120 patients was finally determined, with 60 patients in each group.|||||<|0.01|||||||Chi-squared|||||||<0.01
72334012|NCT01559259|144191642|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|36.98|||<|0.001|TWO_SIDED|95.0|28.48|45.47||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR, baseline numerical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-8 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||45.47|28.48|<0.001
72334013|NCT01559259|144191642|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|35.1|||<|0.001|TWO_SIDED|95.0|26.7|43.5||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR, baseline numerical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-8 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||43.50|26.70|<0.001
72334014|NCT01559259|144191642|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|37.09|||<|0.001|TWO_SIDED|95.0|28.6|45.59||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR, baseline numerical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-8 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||45.59|28.60|<0.001
72334015|NCT01559259|144191642|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|35.17|||<|0.001|TWO_SIDED|95.0|26.67|43.68||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR, baseline numerical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-8 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||43.68|26.67|<0.001
72334016|NCT01559259|144191642|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.8||||0.543|TWO_SIDED|95.0|-4.02|7.63||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR, baseline numerical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-8 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||7.63|-4.02|0.543
72334017|NCT01559259|144191642|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.07||||0.979|TWO_SIDED|95.0|-5.75|5.6||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR, baseline numerical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-8 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||5.60|-5.75|0.979
72334018|NCT01559259|144191642|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.92||||0.517|TWO_SIDED|95.0|-3.9|7.74||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR, baseline numerical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-8 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||7.74|-3.90|0.517
72334019|NCT01559259|144191642|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|42.96|||<|0.001|TWO_SIDED|95.0|30.51|55.41||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR, baseline numerical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-12 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||55.41|30.51|<0.001
72334020|NCT01559259|144191642|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|42.2|||<|0.001|TWO_SIDED|95.0|29.9|54.51||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR, baseline numerical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-12 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||54.51|29.90|<0.001
72334021|NCT01559259|144191642|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|45.12|||<|0.001|TWO_SIDED|95.0|32.67|57.57||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR, baseline numerical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-12 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||57.57|32.67|<0.001
72334022|NCT01559259|144191642|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|44.25|||<|0.001|TWO_SIDED|95.0|31.79|56.71||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR, baseline numerical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-12 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||56.71|31.79|<0.001
72424649|NCT01872910|144360302|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.1|||||TWO_SIDED|95.0|-8.3|4.1|||||95% CrI is reported here, not the CI. Estimation is for TOPAR 0 to 12 h.|||4.1|-8.3|
72334023|NCT01559259|144191642|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-1.29||||0.767|TWO_SIDED|95.0|-9.82|7.25||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR, baseline numerical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-12 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||7.25|-9.82|0.767
72334024|NCT01559259|144191642|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-2.04||||0.629|TWO_SIDED|95.0|-10.36|6.27||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR, baseline numerical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-12 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||6.27|-10.36|0.629
72424650|NCT01872910|144360302|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-7.0|||||TWO_SIDED|95.0|-21.4|7.6|||||95% CrI is reported here, not the CI. Estimation is for TOPAR 0 to 24 h.|||7.6|-21.4|
72424651|NCT01872910|144360303|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.3|||||TWO_SIDED|95.0|-4.2|14.5|||||95% CrI is reported here, not the CI. Estimation is for weighted mean change from baseline pain intensity for 0 to 4 h.|||14.5|-4.2|
72424652|NCT01872910|144360303|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-32.0|||||TWO_SIDED|95.0|-41.5|-22.4|||||95% CrI is reported here, not the CI. Estimation is for weighted mean change from baseline pain intensity for 0 to 4 h.|||-22.4|-41.5|
72424653|NCT01872910|144360303|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|37.3|||||TWO_SIDED|95.0|27.8|46.5|||||95% CrI is reported here, not the CI. Estimation is for weighted mean change from baseline pain intensity for 0 to 4 h.|||46.5|27.8|
72424654|NCT01872910|144360303|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|7.3|||||TWO_SIDED|95.0|-2.9|17.6|||||95% CrI is reported here, not the CI. Estimation is for weighted mean change from baseline pain intensity for 0 to 6 h.|||17.6|-2.9|
72424655|NCT01872910|144360303|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-35.1|||||TWO_SIDED|95.0|-45.6|-24.6|||||95% CrI is reported here, not the CI. Estimation is for weighted mean change from baseline pain intensity for 0 to 6 h.|||-24.6|-45.6|
72424656|NCT01872910|144360303|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|42.5|||||TWO_SIDED|95.0|32.1|52.7|||||95% CrI is reported here, not the CI. Estimation is for weighted mean change from baseline pain intensity for 0 to 6 h.|||52.7|32.1|
72424657|NCT01872910|144360303|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|10.7|||||TWO_SIDED|95.0|-1.0|23.0|||||95% CrI is reported here, not the CI. Estimation is for weighted mean change from baseline pain intensity for 0 to 12 h.|||23.0|-1.0|
72424658|NCT01872910|144360303|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-32.7|||||TWO_SIDED|95.0|-45.1|-20.3|||||95% CrI is reported here, not the CI. Estimation is for weighted mean change from baseline pain intensity for 0 to 12 h.|||-20.3|-45.1|
72424659|NCT01872910|144360303|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|43.5|||||TWO_SIDED|95.0|31.3|55.5|||||95% CrI is reported here, not the CI. Estimation is for weighted mean change from baseline pain intensity for 0 to 12 h.|||55.5|31.3|
72424660|NCT01872910|144360303|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|12.4|||||TWO_SIDED|95.0|-1.6|26.2|||||95% CrI is reported here, not the CI. Estimation is for weighted mean change from baseline pain intensity for 0 to 24 h.|||26.2|-1.6|
72424661|NCT01872910|144360303|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-30.2|||||TWO_SIDED|95.0|-44.0|-16.0|||||95% CrI is reported here, not the CI. Estimation is for weighted mean change from baseline pain intensity for 0 to 24 h.|||-16.0|-44.0|
72424662|NCT01872910|144360303|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|42.6|||||TWO_SIDED|95.0|28.6|56.5|||||95% CrI is reported here, not the CI. Estimation is for weighted mean change from baseline pain intensity for 0 to 24 h.|||56.5|28.6|
72424663|NCT01872910|144360303|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.6|||||TWO_SIDED|95.0|-9.7|12.9|||||95% CrI is reported here, not the CI. Estimation is for weighted mean change from baseline pain intensity for 0 to 4 h.|||12.9|-9.7|
72424664|NCT01872910|144360303|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.5|||||TWO_SIDED|95.0|-9.8|16.8|||||95% CrI is reported here, not the CI. Estimation is for weighted mean change from baseline pain intensity for 0 to 6 h.|||16.8|-9.8|
72424665|NCT01872910|144360303|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.5|||||TWO_SIDED|95.0|-9.9|19.0|||||95% CrI is reported here, not the CI. Estimation is for weighted mean change from baseline pain intensity for 0 to 8 h.|||19.0|-9.9|
72424666|NCT01872910|144360303|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.9|||||TWO_SIDED|95.0|-9.2|21.1|||||95% CrI is reported here, not the CI. Estimation is for weighted mean change from baseline pain intensity for 0 to 12 h.|||21.1|-9.2|
72424667|NCT01872910|144360303|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|7.8|||||TWO_SIDED|95.0|-8.4|24.2|||||95% CrI is reported here, not the CI. Estimation is for weighted mean change from baseline pain intensity for 0 to 24 h.|||24.2|-8.4|
72424668|NCT01872910|144360304|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.6|||||TWO_SIDED|95.0|-0.6|1.9|||||95% CrI is reported here, not the CI. Estimation is SPID 0 to 4 h.|||1.9|-0.6|
72424669|NCT01872910|144360304|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.9|||||TWO_SIDED|95.0|-4.1|-1.7|||||95% CrI is reported here, not the CI. Estimation is for SPID 0 to 4 h.|||-1.7|-4.1|
72424670|NCT01872910|144360304|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.5|||||TWO_SIDED|95.0|2.3|4.8|||||95% CrI is reported here, not the CI. Estimation is for SPID 0 to 4 h.|||4.8|2.3|
72424671|NCT01872910|144360304|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.1|||||TWO_SIDED|95.0|-0.9|3.2|||||95% CrI is reported here, not the CI. Estimation is for SPID 0 to 6 h.|||3.2|-0.9|
72424672|NCT01872910|144360304|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.8|||||TWO_SIDED|95.0|-6.8|-2.7|||||95% CrI is reported here, not the CI. Estimation is for SPID 0 to 6 h.|||-2.7|-6.8|
72424673|NCT01872910|144360304|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.9|||||TWO_SIDED|95.0|3.8|8.0|||||95% CrI is reported here, not the CI. Estimation is for SPID 0 to 6 h.|||8.0|3.8|
72424674|NCT01872910|144360304|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.9|||||TWO_SIDED|95.0|-1.0|4.8|||||95% CrI is reported here, not the CI. Estimation is for SPID 0 to 8 h.|||4.8|-1.0|
72424675|NCT01872910|144360304|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.1|||||TWO_SIDED|95.0|-9.0|-3.3|||||95% CrI is reported here, not the CI. Estimation is for SPID 0 to 8 h.|||-3.3|-9.0|
72424676|NCT01872910|144360304|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|8.0|||||TWO_SIDED|95.0|5.1|10.9|||||95% CrI is reported here, not the CI. Estimation is for SPID 0 to 8 h.|||10.9|5.1|
72424677|NCT01872910|144360304|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.4|||||TWO_SIDED|95.0|-1.3|8.1|||||95% CrI is reported here, not the CI. Estimation is for SPID 0 to 12 h.|||8.1|-1.3|
72424678|NCT01872910|144360304|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-8.2|||||TWO_SIDED|95.0|-12.9|-3.5|||||95% CrI is reported here, not the CI. Estimation is for SPID 0 to 12 h.|||-3.5|-12.9|
72424679|NCT01872910|144360304|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|11.6|||||TWO_SIDED|95.0|7.0|16.5|||||95% CrI is reported here, not the CI. Estimation is for SPID 0 to 12 h.|||16.5|7.0|
72424680|NCT01872910|144360304|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|7.8|||||TWO_SIDED|95.0|-2.6|18.3|||||95% CrI is reported here, not the CI. Estimation is for SPID 0 to 24 h.|||18.3|-2.6|
72424681|NCT01872910|144360304|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-14.1|||||TWO_SIDED|95.0|-24.7|-3.6|||||95% CrI is reported here, not the CI. Estimation is for SPID 0 to 24 h.|||-3.6|-24.7|
72424682|NCT01872910|144360304|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|21.9|||||TWO_SIDED|95.0|11.5|32.2|||||95% CrI is reported here, not the CI. Estimation is for SPID 0 to 24 h.|||32.2|11.5|
72334025|NCT01559259|144191642|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.87||||0.841|TWO_SIDED|95.0|-7.66|9.39||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR, baseline numerical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-12 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||9.39|-7.66|0.841
72424683|NCT01872910|144360304|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.3|||||TWO_SIDED|95.0|-1.6|1.0|||||95% CrI is reported here, not the CI. Estimation is for SPID 0 to 4 h.|||1.0|-1.6|
72424684|NCT01872910|144360304|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0|||||TWO_SIDED|95.0|-2.2|2.1|||||95% CrI is reported here, not the CI. Estimation is for SPID 0 to 6 h.|||2.1|-2.2|
72424685|NCT01872910|144360304|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.2|||||TWO_SIDED|95.0|-2.9|3.3|||||95% CrI is reported here, not the CI. Estimation is for SPID 0 to 8 h.|||3.3|-2.9|
72424686|NCT01872910|144360304|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.9|||||TWO_SIDED|95.0|-3.9|5.7|||||95% CrI is reported here, not the CI. Estimation is for SPID 0 to 12 h.|||5.7|-3.9|
72424687|NCT01872910|144360304|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.1|||||TWO_SIDED|95.0|-6.8|15.0|||||95% CrI is reported here, not the CI. Estimation is for SPID 0 to 24 h.|||15.0|-6.8|
72424688|NCT01872910|144360305|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|1.85|||||TWO_SIDED|95.0|0.99|3.46|||||Hazard ratio (HR) of the treatment differences were estimated based on Cox proportional hazard model including treatment and baseline pain intensity (VAS) as fixed effects.|||3.46|0.99|
72424689|NCT01872910|144360305|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|0.34|||||TWO_SIDED|95.0|0.16|0.72|||||HR of the treatment differences were estimated based on Cox proportional hazard model including treatment and baseline pain intensity (VAS) as fixed effects.|||0.72|0.16|
72424690|NCT01872910|144360305|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|5.48|||||TWO_SIDED|95.0|2.69|11.16|||||HR of the treatment differences were estimated based on Cox proportional hazard model including treatment and baseline pain intensity (VAS) as fixed effects.|||11.16|2.69|
72424691|NCT01872910|144360305|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|1.22|||||TWO_SIDED|95.0|0.57|2.59|||||HR of the treatment differences were estimated based on Cox proportional hazard model including treatment and baseline pain intensity (VAS) as fixed effects.|||2.59|0.57|
72424692|NCT01872910|144360306|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|0.78|||||TWO_SIDED|95.0|0.41|1.47|||||HR of the treatment differences were estimated based on Cox proportional hazard model including treatment and baseline pain intensity (VAS) as fixed effects.|||1.47|0.41|
72334026|NCT01559259|144191643|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|3.97|||<|0.001|TWO_SIDED|95.0|3.22|4.73||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-2 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||4.73|3.22|<0.001
72334027|NCT01559259|144191643|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|3.64|||<|0.001|TWO_SIDED|95.0|2.88|4.39||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-2 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||4.39|2.88|<0.001
72334028|NCT01559259|144191643|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|4.07|||<|0.001|TWO_SIDED|95.0|3.32|4.83||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-2 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||4.83|3.32|<0.001
72334029|NCT01559259|144191643|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|3.39|||<|0.001|TWO_SIDED|95.0|2.64|4.14||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-2 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||4.14|2.64|<0.001
72334030|NCT01559259|144191643|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.58||||0.031|TWO_SIDED|95.0|0.05|1.11||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-2 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||1.11|0.05|0.031
72334031|NCT01559259|144191643|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.24||||0.36|TWO_SIDED|95.0|-0.28|0.77||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-2 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||0.77|-0.28|0.360
72334032|NCT01559259|144191643|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.68||||0.011|TWO_SIDED|95.0|0.15|1.21||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-2 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||1.21|0.15|0.011
72334033|NCT01559259|144191643|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|13.14|||<|0.001|TWO_SIDED|95.0|10.54|15.73||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-6 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||15.73|10.54|<0.001
72424693|NCT01872910|144360306|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|2.15|||||TWO_SIDED|95.0|1.19|3.88|||||HR of the treatment differences were estimated based on Cox proportional hazard model including treatment and baseline pain intensity (VAS) as fixed effects.|||3.88|1.19|
72424694|NCT01872910|144360306|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|0.36|||||TWO_SIDED|95.0|0.19|0.67|||||HR of the treatment differences were estimated based on Cox proportional hazard model including treatment and baseline pain intensity (VAS) as fixed effects.|||0.67|0.19|
72424695|NCT01872910|144360307|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|0.33|||||TWO_SIDED|95.0|0.12|0.88|||||HR of the treatment differences were estimated based on Cox proportional hazard model including treatment and baseline pain intensity (VAS) as fixed effects.|||0.88|0.12|
72424696|NCT01872910|144360307|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|4.16|||||TWO_SIDED|95.0|2.04|8.47|||||HR of the treatment differences were estimated based on Cox proportional hazard model including treatment and baseline pain intensity (VAS) as fixed effects.|||8.47|2.04|
72424697|NCT01872910|144360307|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|0.08|||||TWO_SIDED|95.0|0.03|0.21|||||HR of the treatment differences were estimated based on Cox proportional hazard model including treatment and baseline pain intensity (VAS) as fixed effects.|||0.21|0.03|
72424698|NCT03469349|144360320|SUPERIORITY||Least square mean difference|29.19|STANDARD_ERROR_OF_MEAN|10.083||0.0041|TWO_SIDED|95.0|9.35|49.02|||MMRM|||Least squares means, p-values were obtained using a mixed model for repeated measures (MMRM) analysis of covariance with treatment, center, sex, age group, smoking status, diabetic status, visit and treatment-by-visit interaction as fixed effects and baseline value as covariate.||49.02|9.35|0.0041
72424699|NCT03469349|144360321|SUPERIORITY||Least square mean difference|15.86|STANDARD_ERROR_OF_MEAN|7.814||0.0431|TWO_SIDED|95.0|0.49|31.24|||MMRM|||Week 2: Least squares means, p-values were obtained using a MMRM analysis of covariance with treatment, center, sex, age group, smoking status, diabetic status, visit and treatment-by-visit interaction as fixed effects and baseline value as covariate.||31.24|0.49|0.0431
72424700|NCT03469349|144360321|SUPERIORITY||Least square mean difference|35.51|STANDARD_ERROR_OF_MEAN|12.48||0.0047|TWO_SIDED|95.0|10.96|60.05|||MMRM|||Week 24: Least squares means, p-values were obtained using a MMRM analysis of covariance with treatment, center, sex, age group, smoking status, diabetic status, visit and treatment-by-visit interaction as fixed effects and baseline value as covariate.||60.05|10.96|0.0047
72424701|NCT03469349|144360322|SUPERIORITY|||||||0.0227|||||||MMRM|||Week 2: p-values were obtained using a MMRM analysis of covariance with treatment, center, sex, age group, smoking status, diabetic status, visit and treatment-by-visit interaction as fixed effects and baseline value as covariate.||||0.0227
72424702|NCT03469349|144360322|SUPERIORITY|||||||0.0007|||||||MMRM|||Week 12: p-values were obtained using a MMRM analysis of covariance with treatment, center, sex, age group, smoking status, diabetic status, visit and treatment-by-visit interaction as fixed effects and baseline value as covariate.||||0.0007
72424703|NCT03469349|144360322|SUPERIORITY|||||||0.0023|||||||MMRM|||Week 24: p-values were obtained using a MMRM analysis of covariance with treatment, center, sex, age group, smoking status, diabetic status, visit and treatment-by-visit interaction as fixed effects and baseline value as covariate.||||0.0023
72424704|NCT03469349|144360323|NON_INFERIORITY|As the sample size was too small, clinically significant difference in actovegin and placebo could not be defined, the non-inferiority margin was defined as priori based on clinical reasoning.||||||0.9592||||||p-values were obtained using logistic regression adjusting for treatment.|Regression, Logistic|||Week 12||||0.9592
72424705|NCT03469349|144360323|NON_INFERIORITY|As the sample size was too small, clinically significant difference in actovegin and placebo could not be defined, the non-inferiority margin was defined as priori based on clinical reasoning.||||||0.5823||||||p-values were obtained using logistic regression adjusting for treatment.|Regression, Logistic|||Week 24||||0.5823
72424706|NCT03469349|144360324|NON_INFERIORITY|As the sample size was too small, clinically significant difference in actovegin and placebo could not be defined, the non-inferiority margin was defined as priori based on clinical reasoning.||||||0.9424||||||p-values were obtained using logistic regression adjusting for treatment.|Regression, Logistic|||||||0.9424
72424707|NCT03469349|144360325|SUPERIORITY|||||||0.3758|||||||MMRM|||Physical Health Score: Week 12; Least squares means, p-values were obtained using a MMRM analysis of covariance with treatment, center, sex, age group, smoking status, diabetic status, visit and treatment-by-visit interaction as fixed effects and baseline value as covariate.||||0.3758
72424708|NCT03469349|144360325|SUPERIORITY|||||||0.1412|||||||MMRM|||Physical Health Score: Week 24; Least squares means, p-values were obtained using a MMRM analysis of covariance with treatment, center, sex, age group, smoking status, diabetic status, visit and treatment-by-visit interaction as fixed effects and baseline value as covariate.||||0.1412
72424709|NCT03469349|144360325|SUPERIORITY|||||||0.1009|||||||MMRM|||Mental Health Score: Week 12; Least squares means, p-values were obtained using a MMRM analysis of covariance with treatment, center, sex, age group, smoking status, diabetic status, visit and treatment-by-visit interaction as fixed effects and baseline value as covariate.||||0.1009
72424710|NCT03469349|144360325|SUPERIORITY|||||||0.0015|||||||MMRM|||Mental Health Score: Week 24; Least squares means, p-values were obtained using a MMRM analysis of covariance with treatment, center, sex, age group, smoking status, diabetic status, visit and treatment-by-visit interaction as fixed effects and baseline value as covariate.||||0.0015
72424711|NCT00985543|144360336|NON_INFERIORITY_OR_EQUIVALENCE|Results are considered statistically significant at p\<0.05 or when 90% confidence intervals do not cross the value 1. No adjustments are made for multiple comparisons.|||||<|0.05|TWO_SIDED|90.0|||||maximum likelihood regression|||Dosing regimens lopinavir/ritonavir 200/150mg BID (Phase 2) and lopinavir/ritonavir 200/50mg BID (Phase 3) will be considered equivalent to lopinavir/ritonavir 400/100mg BID (Phase 1) if the 90% confidence interval (CI) for the mean AUC0-12h ratio and maximum concentration (Cmax) ratio lie between 0.80 and 1.25.||||<0.05
72424712|NCT00692406|144360366|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.0023|||<|0.001||95.0|||||ANOVA|||Within group repeated measures design. Null hypothesis is that there will be no difference in percent signal change during active task relative to baseline.||||<0.001
72424713|NCT00692406|144360367|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1167|||<|0.001||95.0|||||ANOVA|||Within group repeated measures design. Null hypothesis is that there will be no difference in percent signal change during active task relative to baseline.||||<0.001
72424714|NCT00692406|144360368|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.0253|||<|0.001||95.0|||||ANOVA|||Within group repeated measures design. Null hypothesis is that there will be no difference in percent signal change during active task relative to baseline.||||<0.001
72424715|NCT00692406|144360369|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1432|||<|0.001||95.0|||||ANOVA|||Within group repeated measures design. Null hypothesis is that there will be no difference in percent signal change during active task relative to baseline.||||<0.001
72424716|NCT00692406|144360370|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.0489|||<|0.001||95.0|||||ANOVA|||Within group repeated measures design. Null hypothesis is that there will be no difference in percent signal change during active task relative to baseline.||||<0.001
72424717|NCT00692406|144360371|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0096|||<|0.001||95.0|||||ANOVA|||Within group repeated measures design. Null hypothesis is that there will be no difference in percent signal change during active task relative to baseline.||||<0.001
72424718|NCT00692406|144360372|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.0372|||<|0.001||95.0|||||ANOVA|||Within group repeated measures design. Null hypothesis is that there will be no difference in percent signal change during active task relative to baseline.||||<0.001
72424719|NCT00692406|144360373|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.121|||<|0.001||95.0|||||ANOVA|||Within group repeated measures design. Null hypothesis is that there will be no difference in percent signal change during active task relative to baseline.||||<0.001
72424720|NCT05952297|144360387|SUPERIORITY|||||||0.88|||||||mixed model|linear mixed model, time x condition effect||||||.88
72424721|NCT03107377|144360390|SUPERIORITY||Risk Difference (RD)|-4.81||||0.0256|TWO_SIDED|95.0|-9.02|-0.61|||Chi-squared|||||-0.61|-9.02|0.0256
72424722|NCT03107377|144360391|SUPERIORITY||Risk Difference (RD)|-2.53||||0.0316|TWO_SIDED|95.0|-4.84|-0.23|||Chi-squared|||||-0.23|-4.84|0.0316
72424723|NCT03107377|144360395|SUPERIORITY|||||||1|||||||Fisher Exact|||A comparison of infection rates between the treatment arms amongst subjects with =0% adherence||||1.0000
72424724|NCT03107377|144360395|SUPERIORITY|||||||1|||||||Fisher Exact|||A comparison of infection rates between the treatment arms amongst subjects with \>0% adherence||||1.0000
72424725|NCT03107377|144360395|SUPERIORITY|||||||0.6278|||||||Fisher Exact|||A comparison of infection rates between the treatment arms amongst subjects with \>=20% adherence||||.6278
72424726|NCT03107377|144360395|SUPERIORITY|||||||0.6404|||||||Fisher Exact|||A comparison of infection rates between the treatment arms amongst subjects with \>=40% adherence||||.6404
72424727|NCT03107377|144360395|SUPERIORITY|||||||0.5008|||||||Fisher Exact|||A comparison of infection rates between the treatment arms amongst subjects with \>=60% adherence||||.5008
72424728|NCT03107377|144360395|SUPERIORITY|||||||0.1818|||||||Chi-squared|||A comparison of infection rates between the treatment arms amongst subjects with \>=80% adherence||||.1818
72424729|NCT03107377|144360395|SUPERIORITY|||||||0.0012|||||||Chi-squared|||A comparison of infection rates between the treatment arms amongst subjects with =100% adherence||||0.0012
72424730|NCT03107377|144360396|SUPERIORITY|||||||1|||||||Fisher Exact|||A comparison of infection rates between the treatment arms amongst subjects with =0% adherence||||1.0000
72424731|NCT03107377|144360396|SUPERIORITY|||||||0.4375|||||||Fisher Exact|||A comparison of infection rates between the treatment arms amongst subjects with \>0% adherence||||0.4375
72424732|NCT03107377|144360396|SUPERIORITY|||||||0.4444|||||||Fisher Exact|||A comparison of infection rates between the treatment arms amongst subjects with \>=20% adherence||||0.4444
72424733|NCT03107377|144360396|SUPERIORITY|||||||0.1836|||||||Fisher Exact|||A comparison of infection rates between the treatment arms amongst subjects with \>=60% adherence||||0.1836
72424734|NCT03107377|144360396|SUPERIORITY|||||||0.5006|||||||Fisher Exact|||A comparison of infection rates between the treatment arms amongst subjects with \>=80% adherence||||0.5006
72424735|NCT03107377|144360396|SUPERIORITY|||||||1|||||||Fisher Exact|||A comparison of infection rates between the treatment arms amongst subjects with =100% adherence||||1.000
72424736|NCT02100722|144360434|NON_INFERIORITY|Noninferiority of FFR-guided PCI to CABG was prespecified as an upper boundary of less than 1.65 for the 95% confidence interval of the hazard ratio.|Hazard Ratio (HR)|1.5||||0.35|TWO_SIDED|95.0|1.1|2.2|||Regression, Cox|||A sample of 712 patients per group (1424 for the entire trial) would be required in order to achieve 90% power to claim noninferiority||2.2|1.1|0.35
72424737|NCT02100722|144360437|OTHER||Hazard Ratio (HR)|1.7|||||TWO_SIDED|95.0|0.7|4.3||||||||4.3|0.7|
72424738|NCT02100722|144360438|OTHER||Hazard Ratio (HR)|1.5|||||TWO_SIDED|95.0|0.9|2.5|||||Hazard ratio for overall number of participants experiencing MI.|||2.5|0.9|
72424739|NCT02100722|144360439|OTHER||Hazard Ratio (HR)|0.9|||||TWO_SIDED|95.0|0.3|2.4||||||||2.4|0.3|
72424740|NCT02100722|144360440|OTHER||Hazard Ratio (HR)|1.5|||||TWO_SIDED|95.0|0.9|2.3|||||Hazard ratio for overall number of participants experiencing repeat revascularization.|||2.3|0.9|
72424741|NCT02100722|144360441|OTHER||||||<|0.01|||||||Fisher Exact|||||||<0.01
72424742|NCT02100722|144360442|OTHER||||||<|0.04|||||||Fisher Exact|||||||<0.04
72424743|NCT02100722|144360443|OTHER||||||<|0.001|||||||Fisher Exact|||||||<0.001
72424744|NCT02100722|144360446|OTHER||||||<|0.001|||||||Chi-squared|||||||<0.001
72424745|NCT05652036|144360534|OTHER|||||||0.21||||||Threshold for statistical significance used P-value \<0.05|t-test, 2 sided|||Difference in NPS score pre- and post-procedure||||0.21
72424746|NCT05652036|144360535|OTHER|||||||0.07||||||Threshold for statistical significance used P-value \<0.05|t-test, 2 sided|||Difference in overactive bladder symptom bother before and after treatment||||.07
72424747|NCT05652036|144360535|OTHER|||||||0.16||||||Threshold for statistical significance used P-value \<0.05|t-test, 2 sided|||Difference in overactive bladder HRQL mean before and after treatment||||0.16
72334034|NCT01559259|144191643|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|11.94|||<|0.001|TWO_SIDED|95.0|9.35|14.52||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-6 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||14.52|9.35|<0.001
72424748|NCT05652036|144360536|OTHER|||||||0.21|||||||Chi-squared|||Participant rated procedural satisfaction assessed 30-days post-procedure.||||0.21
72424749|NCT05652036|144360537|OTHER|Clinical Global Impression of Improvement scale sores reported by participants as very much improved after treatment||||||0.79|||||||Chi-squared|||||||0.79
72424750|NCT05652036|144360537|OTHER|Clinical Global Impression of Improvement scale sores reported by participants as much improved after treatment||||||0.27|||||||Chi-squared|||||||0.27
72424751|NCT05652036|144360537|OTHER|Clinical Global Impression of Improvement scale sores reported by participants as minimally improved after treatment||||||0.14|||||||Chi-squared|||||||0.14
72424752|NCT05652036|144360537|OTHER|Clinical Global Impression of Improvement scale sores reported by participants as no difference after treatment||||||1|||||||Chi-squared|||||||1.0
72424753|NCT05652036|144360538|OTHER|Rates of urinary retention observed in participants after BTX-A treatment.||||||0.5|||||||Chi-squared|||||||0.5
72424754|NCT05652036|144360538|OTHER|Rates of urinary tract infection observed in participants after BTX-A treatment.||||||0.24|||||||Chi-squared|||||||0.24
72424755|NCT05652036|144360538|OTHER|Rates of bleeding requiring evaluation observed in participants after BTX-A treatment.||||||1|||||||Chi-squared|||||||1.0
72424756|NCT05652036|144360538|OTHER|Rates of hematuria observed in participants after BTX-A treatment.||||||0.46|||||||Chi-squared|||||||0.46
72424757|NCT05652036|144360538|OTHER|Rates of bladder pain observed in participants after BTX-A treatment.||||||1|||||||Chi-squared|||||||1.0
72424758|NCT05652036|144360538|OTHER|Rates of ER department evaluations observed in participants after BTX-A treatment.||||||0.5|||||||Chi-squared|||||||0.5
72424759|NCT03500640|144360542|SUPERIORITY|||||||0.196||||||The a priori threshold for statistical significance was p = 0.05|t-test, 2 sided|||||||0.196
72424760|NCT03500640|144360543|SUPERIORITY|||||||0.8||||||The a priori threshold for statistical significance was p = 0.05|t-test, 2 sided|||||||0.800
72424761|NCT03500640|144360544|SUPERIORITY|||||||0.677|||||||t-test, 2 sided|||||||0.677
72424762|NCT03500640|144360545|SUPERIORITY|||||||0.349||||||The a priori threshold for statistical significance was p = 0.05|t-test, 2 sided|||||||0.349
72424763|NCT03500640|144360546|SUPERIORITY|||||||0.891|||||||t-test, 2 sided|||||||0.891
72424764|NCT03500640|144360547|SUPERIORITY|||||||0.14||||||The a priori threshold for statistical significance was p = 0.05|t-test, 2 sided|||||||0.140
72424765|NCT03500640|144360548|SUPERIORITY|||||||0.732|||||||t-test, 2 sided|||||||0.732
72424766|NCT03500640|144360549|SUPERIORITY|||||||0.637||||||The a priori threshold for statistical significance was p = 0.05|t-test, 2 sided|||||||0.637
72424767|NCT03500640|144360550|SUPERIORITY|||||||0.521||||||The a priori threshold for statistical significance was p = 0.05|t-test, 2 sided|||||||0.521
72424768|NCT03500640|144360551|SUPERIORITY|||||||0.083||||||The a priori threshold for statistical significance is 0.05.|t-test, 2 sided|||||||0.083
72424769|NCT03500640|144360552|SUPERIORITY|||||||0.778||||||The a priori threshold for statistical significance is 0.05.|t-test, 2 sided|||||||0.778
72424770|NCT03500640|144360553|SUPERIORITY|||||||0.982||||||The a priori threshold for statistical significance is 0.05.|t-test, 2 sided|||||||0.982
72424771|NCT03500640|144360554|SUPERIORITY|||||||0.081||||||The a priori threshold for statistical significance is 0.05.|t-test, 2 sided|||||||0.081
72424772|NCT03500640|144360555|SUPERIORITY|||||||0.712||||||The a priori threshold for statistical significance is 0.05.|t-test, 2 sided|||||||0.712
72424773|NCT03500640|144360556|SUPERIORITY|||||||0.371||||||The a priori threshold for statistical significance is 0.05|t-test, 2 sided|||||||0.371
72424774|NCT03500640|144360557|SUPERIORITY|||||||0.801||||||The a priori threshold for statistical significance is 0.05|t-test, 2 sided|||||||0.801
72424775|NCT03500640|144360558|SUPERIORITY|||||||0.069||||||The a priori threshold for statistical significance is 0.05|t-test, 2 sided|||||||0.069
72424776|NCT03500640|144360559|SUPERIORITY|||||||0.193||||||The a priori threshold for statistical significance is 0.05|t-test, 2 sided|||||||0.193
72424777|NCT03500640|144360560|SUPERIORITY|||||||0.197||||||The a priori threshold for statistical significance is 0.05|t-test, 2 sided|||||||0.197
72424778|NCT03500640|144360561|SUPERIORITY|||||||0.594||||||The a priori threshold for statistical significance is 0.05|t-test, 2 sided|||||||0.594
72424779|NCT03500640|144360562|SUPERIORITY|||||||0.328|||||||t-test, 2 sided|||||||0.328
72424780|NCT03500640|144360563|SUPERIORITY|||||||0.398||||||The a priori threshold for statistical significance is 0.05|t-test, 2 sided|||||||0.398
72334035|NCT01559259|144191643|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|13.54|||<|0.001|TWO_SIDED|95.0|10.95|16.13||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-6 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||16.13|10.95|<0.001
72424781|NCT03500640|144360564|SUPERIORITY|||||||0.288||||||The a priori threshold for statistical significance is 0.05|t-test, 2 sided|||||||0.288
72424782|NCT03500640|144360565|SUPERIORITY|||||||0.592||||||The a priori threshold for statistical significance is 0.05|t-test, 2 sided|||||||0.592
72424783|NCT03500640|144360566|SUPERIORITY|||||||0.805||||||The a priori threshold for statistical significance is 0.05|t-test, 2 sided|||||||0.805
72424784|NCT03500640|144360567|SUPERIORITY|||||||0.421||||||The a priori threshold for significance is 0.05|t-test, 2 sided|||The p value provided here is for the physical component summary score (PCS) only||||0.421
72424785|NCT03500640|144360568|SUPERIORITY|The p value provided here is for the physical component summary score (PCS) only||||||0.16|||||||t-test, 2 sided|||||||0.160
72424786|NCT03500640|144360569|SUPERIORITY|||||||0.196||||||The a priori threshold for significance is 0.05|t-test, 2 sided|||||||0.196
72424787|NCT03500640|144360570|SUPERIORITY|||||||0.532||||||The a priori threshold for statistical significance is 0.05|t-test, 2 sided|||||||0.532
72424788|NCT05408468|144360583|SUPERIORITY||Mean Difference (Net)|-5.595|STANDARD_ERROR_OF_MEAN|1.731||0.387|TWO_SIDED||||||Mixed Models Analysis||Baseline 1.731 One week 1.894|||||0.387
72424789|NCT05408468|144360583|SUPERIORITY||Mean Difference (Net)|-3.782|STANDARD_ERROR_OF_MEAN|2.048||0.387|TWO_SIDED||||||Mixed Models Analysis||Baseline 2.048 One week 2.122|||||0.387
72424790|NCT05408468|144360584|SUPERIORITY||Mean Difference (Net)|-4.5|STANDARD_ERROR_OF_MEAN|1.693||0.062|TWO_SIDED||||||Mixed Models Analysis||Baseline 1.693 One week 1.840|||||0.062
72424791|NCT05408468|144360584|SUPERIORITY||Mean Difference (Net)|-0.764|STANDARD_ERROR_OF_MEAN|2.003||0.062|TWO_SIDED||||||Mixed Models Analysis||Baseline 2.003 One week 2.069|||||0.062
72424792|NCT05408468|144360586|SUPERIORITY||Median Difference (Final Values)|2.58|STANDARD_ERROR_OF_MEAN|2.84||0.369|TWO_SIDED||||||t-test, 2 sided|||||||0.369
72424793|NCT05408468|144360587|SUPERIORITY||Median Difference (Final Values)|2.59|STANDARD_ERROR_OF_MEAN|3.79||0.498|TWO_SIDED||||||t-test, 2 sided|||||||0.498
72424794|NCT00930943|144360597|SUPERIORITY||||||<|0.001||||||repeated-measure ANOVA tested time-post-dose effect for Rapid Visual Information Processing (RVP): sensitivity (A')|ANOVA|||The a priori sample-size estimation for a power of 80% with alpha = 0.05 was based on the primary-outcome measure, the rapid visual information processing (RVP) sensitivity (A') score. Using a repeated-measure ANOVA for the food effect (fed versus fasting) and assuming an effect size of f =0.26 generated a required sample size of 32 participants. However, only 30 subjects completed both testing visits, generating a power of 78.2%.|(F\[1,28\] = 22.71; η2 = 0.45)|||<0.001
72424795|NCT00930943|144360597|SUPERIORITY|||||||0.01||||||repeated-measure ANOVA tested food x time-post-dose effect for Rapid Visual Information Processing (RVP): sensitivity (A')|ANOVA||||F\[1,28\]=6.88; η2=0.20|||0.01
72424796|NCT00930943|144360597|SUPERIORITY||||||>|0.05||||||repeated-measure ANOVA testing food effect for Rapid Visual Information Processing (RVP): sensitivity (A')|ANOVA|||||||>0.05
72424797|NCT00930943|144360598|SUPERIORITY||||||<|0.001||||||Repeated-measure ANOVA testing time-post-dose effect for Rapid Visual Information Processing (RVP): response latency|ANOVA||||(F\[1,28\] = 14.05; η2 = 0.33)|||<0.001
72424798|NCT00930943|144360598|SUPERIORITY||||||>|0.05||||||"repeated-measure ANOVA testing food and food x time post dose effect for Rapid Visual Information Processing (RVP): response latency"|ANOVA|||||||>0.05
72424799|NCT00930943|144360599|SUPERIORITY||||||>|0.05||||||"repeated-measure ANOVA testing food, time-post-dose, and food x time-post-dose effect for SRM percentage of correct hits"|ANOVA|||||||>0.05
72424800|NCT00930943|144360600|SUPERIORITY||||||<|0.001||||||Repeated-measure ANOVA testing time-post-dose effect for Spatial Recognition Memory (SRM) response latency|ANOVA||||(F\[1,28\] = 31.26; η2 = 0.53)|||<0.001
72424801|NCT00930943|144360600|SUPERIORITY||||||>|0.05||||||"repeated-measure ANOVA testing food and food x time-post-dose effect for SRM response latency"|ANOVA|||||||>0.05
72424802|NCT00930943|144360601|SUPERIORITY||||||>|0.05||||||"repeated-measure ANOVA testing food, time-post-dose, and food x time-post-dose effect for SWM total errors"|ANOVA|||||||>0.05
72424803|NCT00930943|144360602|SUPERIORITY||||||>|0.05||||||"repeated-measure ANOVA testing food, time-post-dose, and food x time-post-dose effect for SWM strategy score"|ANOVA|||||||>0.05
72424804|NCT01008475|144360604|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.13|||||TWO_SIDED|95.0|0.78|1.64||||||||1.64|0.78|
72424805|NCT01008475|144360604|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.11|||||TWO_SIDED|95.0|0.77|1.61||||||||1.61|0.77|
72424806|NCT01008475|144360605|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.83|||||TWO_SIDED|95.0|0.54|1.28||||||||1.28|0.54|
72424807|NCT01008475|144360605|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.8|||||TWO_SIDED|95.0|0.52|1.25||||||||1.25|0.52|
72424808|NCT01008475|144360606|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.11|||||TWO_SIDED|95.0|0.75|1.65||||||||1.65|0.75|
72424809|NCT01008475|144360606|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.11|||||TWO_SIDED|95.0|0.75|1.65||||||||1.65|0.75|
72424810|NCT01008475|144360608|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.95|||||TWO_SIDED|95.0|0.67|1.34||||||||1.34|0.67|
72424811|NCT01008475|144360608|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.05|||||TWO_SIDED|95.0|0.74|1.48||||||||1.48|0.74|
72424812|NCT01373450|144360626|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.87||||0.024|TWO_SIDED|90.0|0.77|0.98|||t-test, 1 sided|||||0.98|0.77|0.024
72424813|NCT01373450|144360627|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.77||||0.004|TWO_SIDED|90.0|0.66|0.9|||t-test, 1 sided|||||0.90|0.66|0.004
72424814|NCT01373450|144360628|SUPERIORITY_OR_OTHER||Least Square Mean Difference|0.014|||<|0.001|TWO_SIDED|90.0|0.008|0.019|||t-test, 1 sided|||||0.019|0.008|<0.001
72424815|NCT01373450|144360629|SUPERIORITY_OR_OTHER||Intraclass Correlation Coefficient|0.92|||||TWO_SIDED|90.0|0.72|0.98||||||||0.98|0.72|
72424816|NCT01373450|144360630|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.77||||0.003|TWO_SIDED|90.0|0.66|0.9|||t-test, 1 sided|||||0.90|0.66|0.003
72424817|NCT01373450|144360630|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.58|||<|0.001|TWO_SIDED|90.0|0.45|0.74|||t-test, 1 sided|||||0.74|0.45|<0.001
72424818|NCT01373450|144360630|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.99||||0.473|TWO_SIDED|90.0|0.85|1.16|||t-test, 1 sided|||||1.16|0.85|0.473
72424819|NCT01373450|144360630|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.75||||0.049|TWO_SIDED|90.0|0.56|1.0|||t-test, 1 sided|||||1.00|0.56|0.049
72334036|NCT01559259|144191643|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|12.04|||<|0.001|TWO_SIDED|95.0|9.45|14.63||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-6 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||14.63|9.45|<0.001
72334037|NCT01559259|144191643|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.1||||0.235|TWO_SIDED|95.0|-0.72|2.91||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-6 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||2.91|-0.72|0.235
72334038|NCT01559259|144191643|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.1||||0.91|TWO_SIDED|95.0|-1.91|1.7||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-6 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||1.70|-1.91|0.910
72334039|NCT01559259|144191643|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.5||||0.105|TWO_SIDED|95.0|-0.32|3.31||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-6 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||3.31|-0.32|0.105
72334040|NCT01559259|144191643|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|16.05|||<|0.001|TWO_SIDED|95.0|12.49|19.61||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-8 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||19.61|12.49|<0.001
72334041|NCT01559259|144191643|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|14.88|||<|0.001|TWO_SIDED|95.0|11.33|18.43||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-8 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||18.43|11.33|<0.001
72424820|NCT01373450|144360631|SUPERIORITY_OR_OTHER||Least Square Mean Difference|0.021|||<|0.001|TWO_SIDED|90.0|0.015|0.026|||t-test, 1 sided|||||0.026|0.015|<0.001
72424821|NCT01373450|144360631|SUPERIORITY_OR_OTHER||Least Square Mean Difference|0.03|||<|0.001|TWO_SIDED|90.0|0.021|0.038|||t-test, 1 sided|||||0.038|0.021|<0.001
72334042|NCT01559259|144191643|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|16.76|||<|0.001|TWO_SIDED|95.0|13.2|20.32||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-8 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||20.32|13.20|<0.001
72334043|NCT01559259|144191643|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|15.23|||<|0.001|TWO_SIDED|95.0|11.68|18.78||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-8 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||18.78|11.68|<0.001
72334044|NCT01559259|144191643|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.83||||0.514|TWO_SIDED|95.0|-1.66|3.32||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-8 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||3.32|-1.66|0.514
72334045|NCT01559259|144191643|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.35||||0.783|TWO_SIDED|95.0|-2.82|2.13||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-8 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||2.13|-2.82|0.783
72334046|NCT01559259|144191643|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.53||||0.227|TWO_SIDED|95.0|-0.96|4.02||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-8 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||4.02|-0.96|0.227
72334047|NCT01559259|144191643|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|18.28|||<|0.001|TWO_SIDED|95.0|12.95|23.61||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-12 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||23.61|12.95|<0.001
72334048|NCT01559259|144191643|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|17.3|||<|0.001|TWO_SIDED|95.0|11.99|22.61||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-12 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||22.61|11.99|<0.001
72334049|NCT01559259|144191643|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|20.45|||<|0.001|TWO_SIDED|95.0|15.13|25.78||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-12 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||25.78|15.13|<0.001
72334050|NCT01559259|144191643|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|18.92|||<|0.001|TWO_SIDED|95.0|13.61|24.24||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-12 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||24.24|13.61|<0.001
72424822|NCT01373450|144360631|SUPERIORITY_OR_OTHER||Least Square Mean Difference|0.007||||0.0163|TWO_SIDED|90.0|0.002|0.012|||t-test, 1 sided|||||0.012|0.002|0.0163
72424823|NCT01373450|144360631|SUPERIORITY_OR_OTHER||Least Square Mean Difference|0.016||||0.0056|TWO_SIDED|90.0|0.006|0.026|||t-test, 1 sided|||||0.026|0.006|0.0056
72424824|NCT03573908|144360638|SUPERIORITY||Least squares (LS) mean difference|-0.715|||<|0.0001|TWO_SIDED|95.0|-0.998|-0.433|||MMRM||Least squares (LS) mean difference (linaclotide - placebo)|The overall family-wise Type I error rate for the primary and secondary outcome measures were controlled at the α=0.05 level by employing a fixed-sequence testing procedure. Outcome measures were tested using 10 hypotheses, each comparing linaclotide versus placebo, in the sequence of presentation of statistical analyses in this record. If the hypothesis comparing the 2 groups was statistically significant (α=0.05), then the next hypothesis was to be tested; otherwise, testing would stop.||-0.433|-0.998|< 0.0001
72424825|NCT03573908|144360639|SUPERIORITY||Hodges-Lehman Estimated Median Threshold|-0.6|||<|0.0001|TWO_SIDED|95.0|-0.88|-0.35|||Wilcoxon Rank Sum Test|P-value comparing change from baseline distributions by treatment using the Wilcoxon rank sum test 2-sided.|95% confidence interval (CI) for Hodges-Lehmann estimated median threshold was generated by Moses confidence limits method.|The overall family-wise Type I error rate for the primary and secondary outcome measures were controlled at the α=0.05 level by employing a fixed-sequence testing procedure. Outcome measures were tested using 10 hypotheses, each comparing linaclotide versus placebo, in the sequence of presentation of statistical analyses in this record. If the hypothesis comparing the 2 groups was statistically significant (α=0.05), then the next hypothesis was to be tested; otherwise, testing would stop.||-0.35|-0.88|< 0.0001
72424826|NCT03573908|144360640|SUPERIORITY||Difference in Responder Rate|17.1|||||TWO_SIDED|95.0|9.9|24.4|||||95% confidence intervals for difference in responder rate are obtained using the normal approximation to the binomial distribution.|||24.4|9.9|
72424827|NCT03573908|144360640|SUPERIORITY||Odds Ratio (OR)|2.2|||<|0.0001|TWO_SIDED|95.0|1.55|3.12||Odds ratio, 95% CI for the Odds Ratio and p-value vs. placebo are obtained from the Cochran-Mantel-Haenszel (CMH) tests controlling for geographic region.|Cochran-Mantel-Haenszel|||The overall family-wise Type I error rate for the primary and secondary outcome measures were controlled at the α=0.05 level by employing a fixed-sequence testing procedure. Outcome measures were tested using 10 hypotheses, each comparing linaclotide versus placebo, in the sequence of presentation of statistical analyses in this record. If the hypothesis comparing the 2 groups was statistically significant (α=0.05), then the next hypothesis was to be tested; otherwise, testing would stop.||3.12|1.55|< 0.0001
72424828|NCT03573908|144360641|SUPERIORITY||LS mean difference|-0.867|||<|0.0001|TWO_SIDED|95.0|-1.219|-0.515||LS mean difference and p-value were obtained based on an MMRM with treatment, analysis week, geographic region, and treatment-by-week interactions as fixed effects, and baseline score as a covariate.|MMRM|||Week 12. The overall family-wise Type I error rate for primary and secondary outcome measures were controlled at the α=0.05 level by employing a fixed-sequence testing procedure. Outcome measures were tested using 10 hypotheses, each comparing linaclotide versus placebo, in the sequence of presentation of statistical analyses in this record. If the hypothesis comparing the 2 groups was statistically significant (α=0.05), then the next hypothesis was to be tested; otherwise, testing would stop.||-0.515|-1.219|< 0.0001
72424829|NCT03573908|144360641|SUPERIORITY||LS mean difference|-0.719|||<|0.0001|TWO_SIDED|95.0|-1.062|-0.376||LS mean difference and p-value were obtained based on an MMRM with treatment, analysis week, geographic region, and treatment-by-week interactions as fixed effects, and baseline score as a covariate.|MMRM|||Week 10. The overall family-wise Type I error rate for primary and secondary outcome measures were controlled at the α=0.05 level by employing a fixed-sequence testing procedure. Outcome measures were tested using 10 hypotheses, each comparing linaclotide versus placebo, in the sequence of presentation of statistical analyses in this record. If the hypothesis comparing the 2 groups was statistically significant (α=0.05), then the next hypothesis was to be tested; otherwise, testing would stop.||-0.376|-1.062|< 0.0001
72424830|NCT03573908|144360641|SUPERIORITY||LS mean difference|-0.665||||0.0002|TWO_SIDED|95.0|-1.007|-0.322||LS mean difference and p-value were obtained based on an MMRM with treatment, analysis week, geographic region, and treatment-by-week interactions as fixed effects, and baseline score as a covariate.|MMRM|||Week 8. The overall family-wise Type I error rate for primary and secondary outcome measures were controlled at the α=0.05 level by employing a fixed-sequence testing procedure. Outcome measures were tested using 10 hypotheses, each comparing linaclotide versus placebo, in the sequence of presentation of statistical analyses in this record. If the hypothesis comparing the 2 groups was statistically significant (α=0.05), then the next hypothesis was to be tested; otherwise, testing would stop.||-0.322|-1.007|0.0002
72334051|NCT01559259|144191643|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.64||||0.736|TWO_SIDED|95.0|-4.37|3.09||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-12 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||3.09|-4.37|0.736
72334052|NCT01559259|144191643|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-1.62||||0.39|TWO_SIDED|95.0|-5.32|2.08||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-12 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||2.08|-5.32|0.390
72334053|NCT01559259|144191643|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.53||||0.42|TWO_SIDED|95.0|-2.19|5.26||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-12 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||5.26|-2.19|0.420
72334054|NCT01559259|144191644|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|6.5|||<|0.001|TWO_SIDED|95.0|5.25|7.76||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-2 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||7.76|5.25|<0.001
72424831|NCT03573908|144360641|SUPERIORITY||LS mean difference|-0.831|||<|0.0001|TWO_SIDED|95.0|-1.151|-0.511||LS mean difference and p-value were obtained based on an MMRM with treatment, analysis week, geographic region, and treatment-by-week interactions as fixed effects, and baseline score as a covariate.|MMRM|||Week 6. The overall family-wise Type I error rate for primary and secondary outcome measures were controlled at the α=0.05 level by employing a fixed-sequence testing procedure. Outcome measures were tested using 10 hypotheses, each comparing linaclotide versus placebo, in the sequence of presentation of statistical analyses in this record. If the hypothesis comparing the 2 groups was statistically significant (α=0.05), then the next hypothesis was to be tested; otherwise, testing would stop.||-0.511|-1.151|< 0.0001
72424832|NCT03573908|144360641|SUPERIORITY||LS mean difference|-0.683|||<|0.0001|TWO_SIDED|95.0|-0.982|-0.383||LS mean difference and p-value were obtained based on an MMRM with treatment, analysis week, geographic region, and treatment-by-week interactions as fixed effects, and baseline score as a covariate.|MMRM|||Week 4. The overall family-wise Type I error rate for primary and secondary outcome measures were controlled at the α=0.05 level by employing a fixed-sequence testing procedure. Outcome measures were tested using 10 hypotheses, each comparing linaclotide versus placebo, in the sequence of presentation of statistical analyses in this record. If the hypothesis comparing the 2 groups was statistically significant (α=0.05), then the next hypothesis was to be tested; otherwise, testing would stop.||-0.383|-0.982|< 0.0001
72424833|NCT03573908|144360641|SUPERIORITY||LS mean difference|-0.628|||<|0.0001|TWO_SIDED|95.0|-0.888|-0.368||LS mean difference and p-value were obtained based on an MMRM with treatment, analysis week, geographic region, and treatment-by-week interactions as fixed effects, and baseline score as a covariate.|MMRM|||Week 2. The overall family-wise Type I error rate for primary and secondary outcome measures were controlled at the α=0.05 level by employing a fixed-sequence testing procedure. Outcome measures were tested using 10 hypotheses, each comparing linaclotide versus placebo, in the sequence of presentation of statistical analyses in this record. If the hypothesis comparing the 2 groups was statistically significant (α=0.05), then the next hypothesis was to be tested; otherwise, testing would stop.||-0.368|-0.888|< 0.0001
72424834|NCT03573908|144360641|SUPERIORITY||LS mean difference|-0.435|||<|0.0001|TWO_SIDED|95.0|-0.641|-0.228||LS mean difference and p-value were obtained based on an MMRM with treatment, analysis week, geographic region, and treatment-by-week interactions as fixed effects, and baseline score as a covariate.|MMRM|||Week 1. The overall family-wise Type I error rate for primary and secondary outcome measures were controlled at the α=0.05 level by employing a fixed-sequence testing procedure. Outcome measures were tested using 10 hypotheses, each comparing linaclotide versus placebo, in the sequence of presentation of statistical analyses in this record. If the hypothesis comparing the 2 groups was statistically significant (α=0.05), then the next hypothesis was to be tested; otherwise, testing would stop.||-0.228|-0.641|< 0.0001
72424835|NCT03573908|144360641|SUPERIORITY||LS mean difference|-0.683|||<|0.0001|TWO_SIDED|95.0|-0.969|-0.398||LS mean difference and p-value were obtained based on an MMRM with treatment, analysis week, geographic region, and treatment-by-week interactions as fixed effects, and baseline score as a covariate.|MMRM|||Week 3. Not part of the fixed-sequence testing procedure.||-0.398|-0.969|< 0.0001
72424836|NCT03573908|144360641|SUPERIORITY||LS mean difference|-0.768|||<|0.0001|TWO_SIDED|95.0|-1.076|-0.46||LS mean difference and p-value were obtained based on an MMRM with treatment, analysis week, geographic region, and treatment-by-week interactions as fixed effects, and baseline score as a covariate.|MMRM|||Week 5. Not part of the fixed-sequence testing procedure.||-0.460|-1.076|< 0.0001
72424837|NCT03573908|144360641|SUPERIORITY||LS mean difference|-0.758|||<|0.0001|TWO_SIDED|95.0|-1.086|-0.431||LS mean difference and p-value were obtained based on an MMRM with treatment, analysis week, geographic region, and treatment-by-week interactions as fixed effects, and baseline score as a covariate.|MMRM|||Week 7. Not part of the fixed-sequence testing procedure.||-0.431|-1.086|< 0.0001
72334055|NCT01559259|144191644|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|5.87|||<|0.001|TWO_SIDED|95.0|4.62|7.11||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-2 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||7.11|4.62|<0.001
72424838|NCT03573908|144360641|SUPERIORITY||LS mean difference|-0.703|||<|0.0001|TWO_SIDED|95.0|-1.043|-0.363||LS mean difference and p-value were obtained based on an MMRM with treatment, analysis week, geographic region, and treatment-by-week interactions as fixed effects, and baseline score as a covariate.|MMRM|||Week 9. Not part of the fixed-sequence testing procedure.||-0.363|-1.043|< 0.0001
72424839|NCT03573908|144360641|SUPERIORITY||LS mean difference|-0.844|||<|0.0001|TWO_SIDED|95.0|-1.189|-0.498||LS mean difference and p-value were obtained based on an MMRM with treatment, analysis week, geographic region, and treatment-by-week interactions as fixed effects, and baseline score as a covariate.|MMRM|||Week 11. Not part of the fixed-sequence testing procedure.||-0.498|-1.189|< 0.0001
72424840|NCT04006925|144360642|OTHER||Median Difference (Net)|-23.5||||0.03|TWO_SIDED|95.0|-41.0|-2.0||All statistical tests were conducted using a 2-sided alpha level of 0.05.|Wilcoxon Signed Rank test|||Within group analysis of change from baseline.||-2.0|-41.0|0.03
72424841|NCT04006925|144360642|OTHER||Median Difference (Net)|-9.0||||0.11|TWO_SIDED|95.0|-21.5|0.0|||Wilcoxon Signed Rank test|||Within group analysis of change from baseline.||0.0|-21.5|0.11
72424842|NCT04006925|144360642|SUPERIORITY||Median Difference (Net)|-14.5||||0.27|TWO_SIDED|95.0|-32.0|11.3||All statistical tests were conducted using a 2-sided alpha level of 0.05.|Mann Whitney U test|||Between group analysis of change from baseline.||11.3|-32.0|0.27
72424843|NCT04006925|144360643|OTHER||Median Difference (Net)|-1.0||||0.02|TWO_SIDED|95.0|-3.0|0.0||All statistical tests were conducted using a 2-sided alpha level of 0.05.|Wilcoxon Signed Rank test|||Within group analysis of change from baseline.||0.0|-3.0|0.02
72334056|NCT01559259|144191644|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|6.63|||<|0.001|TWO_SIDED|95.0|5.38|7.88||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-2 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||7.88|5.38|<0.001
72334057|NCT01559259|144191644|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|5.48|||<|0.001|TWO_SIDED|95.0|4.23|6.73||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-2 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||6.73|4.23|<0.001
72334058|NCT01559259|144191644|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.03||||0.022|TWO_SIDED|95.0|0.15|1.9||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-2 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||1.90|0.15|0.022
72424844|NCT04006925|144360643|OTHER||Median Difference (Net)|0.0||||0.83|TWO_SIDED|95.0|-1.0|1.0|||Wilcoxon Signed Rank test|||Within group analysis of change from baseline.||1.0|-1.0|0.83
72424845|NCT04006925|144360643|SUPERIORITY||Median Difference (Net)|-1.0||||0.09|TWO_SIDED|95.0|-3.5|0.0||All statistical tests were conducted using a 2-sided alpha level of 0.05.|Mann Whitney U test|||Between group analysis of change from baseline.||0.0|-3.5|0.09
72424846|NCT04006925|144360644|SUPERIORITY|||||||0.08||||||All statistical tests were conducted using a 2-sided alpha level of 0.05.|Mann Whitney U test|||Between group analysis of change from baseline.||||0.08
72424847|NCT04006925|144360645|SUPERIORITY|||||||0.18||||||All statistical tests were conducted using a 2-sided alpha level of 0.05.|Mann Whitney U test|||Between group analysis of change from baseline.||||0.18
72424848|NCT04006925|144360646|OTHER||Median Difference (Net)|-1.0||||0.26|TWO_SIDED|95.0|-7.0|2.0||All statistical tests were conducted using a 2-sided alpha level of 0.05.|Wilcoxon Signed Rank test|||Within group analysis of change from baseline.||2.0|-7.0|0.26
72424849|NCT04006925|144360646|OTHER||Median Difference (Final Values)|-0.5||||0.43|TWO_SIDED|95.0|-3.5|2.0||All statistical tests were conducted using a 2-sided alpha level of 0.05.|Wilcoxon Signed Rank test|||Within group analysis of change from baseline.||2.0|-3.5|0.43
72369432|NCT03894813|144248842|NON_INFERIORITY|The relevant parameters were determined as follows: test level α=0.05, test power 1-β=0.80, Pt=0.90, Pc=0.75, Nt:Nc=1:1, boundary value Δ= -0.0.068 (excellent), and Fisher's exact test. As a result, the sample size of each group was calculated as 50 patients, 100 patients in total. Considering a loss to follow-up rate of 20%, a sample size of 120 patients was finally determined, with 60 patients in each group.|||||<|0.01|||||||Chi-squared|||||||<0.01
72424850|NCT04006925|144360646|SUPERIORITY||Median Difference (Final Values)|-0.5||||0.65|TWO_SIDED|95.0|-4.0|3.0||All statistical tests were conducted using a 2-sided alpha level of 0.05.|Mann Whitney U test|||Between group analysis of change from baseline.||3.0|-4.0|0.65
72334059|NCT01559259|144191644|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.39||||0.38|TWO_SIDED|95.0|-0.48|1.26||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-2 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||1.26|-0.48|0.380
72424851|NCT04006925|144360647|OTHER||Mean Difference (Net)|-6.2||||0.23|TWO_SIDED|95.0|-15.2|1.7||All statistical tests were conducted using a 2-sided alpha level of 0.05.|Unpaired T-test|||Within group analysis of change from baseline.||1.7|-15.2|0.23
72334060|NCT01559259|144191644|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.15||||0.01|TWO_SIDED|95.0|0.28|2.03||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-2 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||2.03|0.28|0.010
72334061|NCT01559259|144191644|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|21.52|||<|0.001|TWO_SIDED|95.0|17.17|25.87||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-6 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||25.87|17.17|<0.001
72334062|NCT01559259|144191644|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|19.62|||<|0.001|TWO_SIDED|95.0|15.29|23.95||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR, baseline numerical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-6 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||23.95|15.29|<0.001
72334063|NCT01559259|144191644|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|22.24|||<|0.001|TWO_SIDED|95.0|17.89|26.59||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-6 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||26.59|17.89|<0.001
72334064|NCT01559259|144191644|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|19.69|||<|0.001|TWO_SIDED|95.0|15.35|24.02||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-6 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||24.02|15.35|<0.001
72334065|NCT01559259|144191644|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.83||||0.237|TWO_SIDED|95.0|-1.21|4.88||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-6 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||4.88|-1.21|0.237
72334066|NCT01559259|144191644|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.07||||0.965|TWO_SIDED|95.0|-3.09|2.95||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-6 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||2.95|-3.09|0.965
72424852|NCT04006925|144360647|OTHER||Mean Difference (Net)|0.2||||0.95|TWO_SIDED|95.0|-4.6|4.5||All statistical tests were conducted using a 2-sided alpha level of 0.05.|Unpaired T-test|||Within group analysis of change from baseline.||4.5|-4.6|0.95
72424853|NCT04006925|144360647|SUPERIORITY||Mean Difference (Net)|-6.4||||0.22|TWO_SIDED|95.0|-16.2|3.1||All statistical tests were conducted using a 2-sided alpha level of 0.05.|Paired T-test|||Between group analysis of change from baseline.||3.1|-16.2|0.22
72334067|NCT01559259|144191644|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.56||||0.099|TWO_SIDED|95.0|-0.48|5.6||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-6 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||5.60|-0.48|0.099
72334068|NCT01559259|144191644|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|29.93|||<|0.001|TWO_SIDED|95.0|21.14|38.73||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-12 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||38.73|21.14|<0.001
72334069|NCT01559259|144191644|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|28.24|||<|0.001|TWO_SIDED|95.0|19.48|37.0||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-12 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||37.00|19.48|<0.001
72334070|NCT01559259|144191644|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|33.1|||<|0.001|TWO_SIDED|95.0|24.31|41.89||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-12 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||41.89|24.31|<0.001
72334071|NCT01559259|144191644|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|30.64|||<|0.001|TWO_SIDED|95.0|21.87|39.41||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-12 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||39.41|21.87|<0.001
72334072|NCT01559259|144191644|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.71||||0.821|TWO_SIDED|95.0|-6.86|5.44||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-12 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||5.44|-6.86|0.821
72334073|NCT01559259|144191644|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-2.4||||0.44|TWO_SIDED|95.0|-8.51|3.71||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-12 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||3.71|-8.51|0.440
72334074|NCT01559259|144191644|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.46||||0.432|TWO_SIDED|95.0|-3.69|8.61||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-12 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||8.61|-3.69|0.432
72334075|NCT01559259|144191645|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|1.08||||0.571|TWO_SIDED|95.0|-1.04|3.2||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||0.25 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and its associated 95% CI was calculated based on Cochran-Mantel-Haenszel (CMH) adjusted proportions and the corresponding standard error.||3.20|-1.04|0.571
72334076|NCT01559259|144191645|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|0.98||||0.593|TWO_SIDED|95.0|-0.94|2.9||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||0.25 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||2.90|-0.94|0.593
72334077|NCT01559259|144191645|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|3.65||||0.282|TWO_SIDED|95.0|-0.39|7.68||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||0.25 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||7.68|-0.39|0.282
72334078|NCT01559259|144191645|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|1.16||||0.552|TWO_SIDED|95.0|-1.11|3.42||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||0.25 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||3.42|-1.11|0.552
72334079|NCT01559259|144191645|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-0.01||||0.994|TWO_SIDED|95.0|-3.13|3.11||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||0.25 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||3.11|-3.13|0.994
72334080|NCT01559259|144191645|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-0.23||||0.879|TWO_SIDED|95.0|-3.26|2.8||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||0.25 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||2.80|-3.26|0.879
72334081|NCT01559259|144191645|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|2.33||||0.28|TWO_SIDED|95.0|-1.98|6.64||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||0.25 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||6.64|-1.98|0.280
72334082|NCT01559259|144191645|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|33.67|||<|0.001|TWO_SIDED|95.0|24.54|42.81||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||0.5 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||42.81|24.54|<0.001
72334083|NCT01559259|144191645|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|23.34||||0.003|TWO_SIDED|95.0|14.93|31.75||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||0.5 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||31.75|14.93|0.003
72334084|NCT01559259|144191645|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|22.28||||0.005|TWO_SIDED|95.0|13.55|31.0||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||0.5 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||31.00|13.55|0.005
72334085|NCT01559259|144191645|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|13.39||||0.035|TWO_SIDED|95.0|6.28|20.5||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||0.5 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||20.50|6.28|0.035
72334086|NCT01559259|144191645|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|20.14||||0.001|TWO_SIDED|95.0|8.67|31.62||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||0.5 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||31.62|8.67|0.001
72334087|NCT01559259|144191645|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|9.56||||0.088|TWO_SIDED|95.0|-1.39|20.51||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||0.5 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||20.51|-1.39|0.088
72334088|NCT01559259|144191645|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|9.36||||0.1|TWO_SIDED|95.0|-1.73|20.45||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||0.5 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||20.45|-1.73|0.100
72334089|NCT01559259|144191645|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|62.54|||<|0.001|TWO_SIDED|95.0|50.93|74.15||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||1 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||74.15|50.93|<0.001
72334090|NCT01559259|144191645|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|51.66|||<|0.001|TWO_SIDED|95.0|39.5|63.82||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||1 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||63.82|39.50|<0.001
72424854|NCT01755143|144360649|SUPERIORITY_OR_OTHER||Percentage|100.0|||<|0.0001|ONE_SIDED|97.5|97.7|||A priori threshold for statistical significance was 0.025|exact test of binomial proportions|||Null Hypothesis: MRI-related complication-free rate between the MRI scan and one-month post-MRI \<90%.|||97.7|<0.0001
72424855|NCT01755143|144360650|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin was 10%.|Risk Difference (RD)|0.0|||||TWO_SIDED|||||A priori threshold for statistical significance was 0.025. Because there were no failures in either group, a p-value could not be calculated.|Farrington-Manning test|||Null hypothesis: % successes MRI group ≤ % successes Control group -10%.||||
72424856|NCT01755143|144360651|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin was 10%.|Risk Difference (RD)|-0.7|||<|0.0001|TWO_SIDED|95.0|-5.4|4.1||A priori threshold for statistical significance was 0.025.|Farrington-Manning test|||Null hypothesis: % successes MRI group ≤ % successes Control group -10%.||4.1|-5.4|<0.0001
72424857|NCT01755143|144360652|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin was 10%.|Risk Difference (RD)|1.6|||<|0.0001|ONE_SIDED|95.0|-3.2|||A priori threshold for statistical significance was 0.05.|Farrington-Manning test|||Null hypothesis: % successes MRI group ≤ % successes Control group - 10%.|||-3.2|<0.0001
72424858|NCT01755143|144360653|SUPERIORITY_OR_OTHER||Percentage|0.0|||<|0.0001|ONE_SIDED|95.0||1.9|||exact test of binomial proportions|A priori threshold for statistical significance was 0.05.||Null hypothesis: the proportion of subjects with sustained ventricular arrhythmias and asystole during MRI scans \>= 10%.||1.9||<0.0001
72334091|NCT01559259|144191645|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|64.68|||<|0.001|TWO_SIDED|95.0|52.92|76.43||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||1 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||76.43|52.92|<0.001
72334092|NCT01559259|144191645|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|52.03|||<|0.001|TWO_SIDED|95.0|40.43|63.63||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||1 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||63.63|40.43|<0.001
72334093|NCT01559259|144191645|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|10.66||||0.138|TWO_SIDED|95.0|-3.04|24.35||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||1 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||24.35|-3.04|0.138
72334094|NCT01559259|144191645|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-0.59||||0.935|TWO_SIDED|95.0|-14.71|13.52||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||1 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||13.52|-14.71|0.935
72334095|NCT01559259|144191645|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|13.3||||0.063|TWO_SIDED|95.0|-0.57|27.17||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||1 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||27.17|-0.57|0.063
72334096|NCT01559259|144191645|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|74.68|||<|0.001|TWO_SIDED|95.0|62.82|86.53||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||1.5 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||86.53|62.82|<0.001
72334097|NCT01559259|144191645|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|63.18|||<|0.001|TWO_SIDED|95.0|50.42|75.95||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||1.5 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||75.95|50.42|<0.001
72334098|NCT01559259|144191645|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|71.39|||<|0.001|TWO_SIDED|95.0|59.21|83.57||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||1.5 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||83.57|59.21|<0.001
72334099|NCT01559259|144191645|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|60.5|||<|0.001|TWO_SIDED|95.0|47.89|73.11||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||1.5 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||73.11|47.89|<0.001
72334100|NCT01559259|144191645|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|14.43||||0.027|TWO_SIDED|95.0|1.97|26.89||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||1.5 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||26.89|1.97|0.027
72334101|NCT01559259|144191645|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|2.35||||0.729|TWO_SIDED|95.0|-10.91|15.61||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||1.5 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||15.61|-10.91|0.729
72424859|NCT01755143|144360654|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin was 10%.|Risk Difference (RD)|0.2||||0.0004|ONE_SIDED|95.0|-4.8||||Farrington-Manning test|A priori threshold for statistical significance was 0.05.||Null hypothesis: % successes MRI group ≤ % successes Control group - 10%.|||-4.8|0.0004
72334102|NCT01559259|144191645|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|11.33||||0.087|TWO_SIDED|95.0|-1.55|24.21||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||1.5 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||24.21|-1.55|0.087
72334103|NCT01559259|144191645|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|75.6|||<|0.001|TWO_SIDED|95.0|62.5|88.7||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||2 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||88.70|62.50|<0.001
72334104|NCT01559259|144191645|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|67.45|||<|0.001|TWO_SIDED|95.0|53.65|81.24||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||2 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||81.24|53.65|<0.001
72334105|NCT01559259|144191645|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|74.46|||<|0.001|TWO_SIDED|95.0|61.21|87.7||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||2 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||87.70|61.21|<0.001
72424860|NCT04466215|144360655|SUPERIORITY||Slope|-0.063|STANDARD_ERROR_OF_MEAN|0.04||0.065|TWO_SIDED|||||One-tail test of directional hypothesis.|Mixed Models Analysis|||Mixed effect model with directional hypothesis that drug reduces strength of craving (VAS). Principle predictor was drug plasma concentration. Arms were combined for this analysis.||||.065
72334106|NCT01559259|144191645|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|64.23|||<|0.001|TWO_SIDED|95.0|50.3|78.17||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||2 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||78.17|50.30|<0.001
72334107|NCT01559259|144191645|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|11.59||||0.052|TWO_SIDED|95.0|0.12|23.06||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||2 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||23.06|0.12|0.052
72334108|NCT01559259|144191645|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|2.84||||0.652|TWO_SIDED|95.0|-9.49|15.16||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||2 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||15.16|-9.49|0.652
72334109|NCT01559259|144191645|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|10.28||||0.09|TWO_SIDED|95.0|-1.47|22.03||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||2 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||22.03|-1.47|0.090
72334110|NCT01559259|144191645|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|79.93|||<|0.001|TWO_SIDED|95.0|67.41|92.46||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||3 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||92.46|67.41|<0.001
72334111|NCT01559259|144191645|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|71.65|||<|0.001|TWO_SIDED|95.0|58.25|85.05||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||3 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||85.05|58.25|<0.001
72334112|NCT01559259|144191645|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|78.92|||<|0.001|TWO_SIDED|95.0|66.29|91.56||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||3 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||91.56|66.29|<0.001
72334113|NCT01559259|144191645|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|70.56|||<|0.001|TWO_SIDED|95.0|57.04|84.07||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||3 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||84.07|57.04|<0.001
72334114|NCT01559259|144191645|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|9.61||||0.069|TWO_SIDED|95.0|-0.59|19.8||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||3 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||19.80|-0.59|0.069
72334115|NCT01559259|144191645|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|0.65||||0.911|TWO_SIDED|95.0|-10.73|12.03||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||3 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||12.03|-10.73|0.911
72334116|NCT01559259|144191645|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|8.27||||0.127|TWO_SIDED|95.0|-2.23|18.77||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||3 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||18.77|-2.23|0.127
72334117|NCT01559259|144191645|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|76.55|||<|0.001|TWO_SIDED|95.0|62.37|90.72||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||4 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||90.72|62.37|<0.001
72334118|NCT01559259|144191645|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|70.6|||<|0.001|TWO_SIDED|95.0|55.93|85.28||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||4 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||85.28|55.93|<0.001
72334119|NCT01559259|144191645|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|76.5|||<|0.001|TWO_SIDED|95.0|62.22|90.79||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||4 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||90.79|62.22|<0.001
72334120|NCT01559259|144191645|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|68.05|||<|0.001|TWO_SIDED|95.0|53.02|83.09||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||4 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||83.09|53.02|<0.001
72334121|NCT01559259|144191645|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|8.57||||0.098|TWO_SIDED|95.0|-1.47|18.61||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||4 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||18.61|-1.47|0.098
72334122|NCT01559259|144191645|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|2.01||||0.721|TWO_SIDED|95.0|-9.02|13.04||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||4 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||13.04|-9.02|0.721
72334123|NCT01559259|144191645|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|8.28||||0.115|TWO_SIDED|95.0|-1.85|18.41||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||4 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||18.41|-1.85|0.115
72334124|NCT01559259|144191645|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|77.66|||<|0.001|TWO_SIDED|95.0|63.63|91.69||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||5 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||91.69|63.63|<0.001
72334125|NCT01559259|144191645|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|71.65|||<|0.001|TWO_SIDED|95.0|57.07|86.22||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||5 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||86.22|57.07|<0.001
72334126|NCT01559259|144191645|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|76.5|||<|0.001|TWO_SIDED|95.0|62.22|90.79||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||5 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||90.79|62.22|<0.001
72334127|NCT01559259|144191645|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|69.1|||<|0.001|TWO_SIDED|95.0|54.14|84.06||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||5 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||84.06|54.14|<0.001
72334128|NCT01559259|144191645|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|8.56||||0.086|TWO_SIDED|95.0|-1.15|18.27||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||5 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||18.27|-1.15|0.086
72334129|NCT01559259|144191645|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|2.01||||0.714|TWO_SIDED|95.0|-8.76|12.77||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||5 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||12.77|-8.76|0.714
72334130|NCT01559259|144191645|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|7.21||||0.164|TWO_SIDED|95.0|-2.8|17.22||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||5 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||17.22|-2.80|0.164
72334131|NCT01559259|144191645|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|74.38|||<|0.001|TWO_SIDED|95.0|59.56|89.2||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||6 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||89.20|59.56|<0.001
72334132|NCT01559259|144191645|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|69.5|||<|0.001|TWO_SIDED|95.0|54.29|84.7||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||6 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||84.70|54.29|<0.001
72334133|NCT01559259|144191645|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|73.24|||<|0.001|TWO_SIDED|95.0|58.18|88.3||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||6 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||88.30|58.18|<0.001
72334134|NCT01559259|144191645|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|67.0|||<|0.001|TWO_SIDED|95.0|51.4|82.61||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||6 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||82.61|51.40|<0.001
72334135|NCT01559259|144191645|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|7.46||||0.129|TWO_SIDED|95.0|-2.12|17.04||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||6 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||17.04|-2.12|0.129
72334136|NCT01559259|144191645|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|1.97||||0.712|TWO_SIDED|95.0|-8.5|12.43||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||6 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||12.43|-8.50|0.712
72334137|NCT01559259|144191645|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|6.12||||0.229|TWO_SIDED|95.0|-3.76|16.0||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||6 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||16.00|-3.76|0.229
72334138|NCT01559259|144191645|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|74.38|||<|0.001|TWO_SIDED|95.0|59.56|89.2||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||7 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||89.20|59.56|<0.001
72334139|NCT01559259|144191645|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|70.54|||<|0.001|TWO_SIDED|95.0|55.45|85.64||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||7 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||85.64|55.45|<0.001
72334140|NCT01559259|144191645|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|73.24|||<|0.001|TWO_SIDED|95.0|58.18|88.3||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||7 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||88.30|58.18|<0.001
72334141|NCT01559259|144191645|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|68.05|||<|0.001|TWO_SIDED|95.0|52.53|83.57||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||7 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||83.57|52.53|<0.001
72334142|NCT01559259|144191645|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|6.38||||0.186|TWO_SIDED|95.0|-3.05|15.81||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||7 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||15.81|-3.05|0.186
72334143|NCT01559259|144191645|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|1.97||||0.703|TWO_SIDED|95.0|-8.18|12.12||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||7 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||12.12|-8.18|0.703
72334144|NCT01559259|144191645|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|5.06||||0.312|TWO_SIDED|95.0|-4.68|14.79||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||7 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||14.79|-4.68|0.312
72334145|NCT01559259|144191645|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|74.38|||<|0.001|TWO_SIDED|95.0|59.56|89.2||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||8 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||89.20|59.56|<0.001
72334146|NCT01559259|144191645|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|71.59|||<|0.001|TWO_SIDED|95.0|56.61|86.57||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||8 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||86.57|56.61|<0.001
72334147|NCT01559259|144191645|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|73.24|||<|0.001|TWO_SIDED|95.0|58.18|88.3||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||8 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||88.30|58.18|<0.001
72334148|NCT01559259|144191645|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|69.21|||<|0.001|TWO_SIDED|95.0|53.86|84.56||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||8 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||84.56|53.86|<0.001
72334149|NCT01559259|144191645|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|5.25||||0.265|TWO_SIDED|95.0|-3.92|14.41||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||8 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||14.41|-3.92|0.265
72424861|NCT01555164|144360660|SUPERIORITY_OR_OTHER||difference in least squares mean (LSM)|-0.11||||0.306|TWO_SIDED|95.0|-0.31|0.1||P-value from a mixed-effect model including terms for baseline HbA1c value, treatment group, visit week, and treatment by visit week interaction. Unstructured covariance matrix was used.|Mixed Effects Model Analysis||The estimation (LSM) is of the placebo-corrected change from baseline.|Assuming a common standard deviation of 1.2%, an effective sample size of 400 would provide at least 90% power to detect a statistically significant treatment difference of -0.4% (ranolazine vs. placebo) for the reduction of HbA1c from baseline at Week 24 based on a 2-sided alpha of 0.05 and 1:1 randomization.||0.10|-0.31|0.306
72424862|NCT00926003|144360663|SUPERIORITY|||||||0.02|||||||ANCOVA|||Least Square Means from Longitudinal Model, Their Standard Errors by Trial Arm Adjusted for Age, Being on ART at Intake, Socioeconomic Score, Home Score, Recruitment Location, KABC Learning and Delayed Recall Scores at Baseline, and Outcome Score at Baseline||||0.02
72424863|NCT00926003|144360664|SUPERIORITY|||||||0.18|||||||ANCOVA|||Least Square Means from Longitudinal Model, Their Standard Errors by Trial Arm Adjusted for Age, Being on ARV at Intake, Socioeconomic Score, Home Score, Recruitment Location, KABC Learning and Delayed Recall Scores at Baseline, and Outcome Score at Baseline||||0.18
72424864|NCT01709305|144360674|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority criterion are met when the upper limit of the two-sided 98.34% CI for the difference in LS means is less than or equal to the pre-specified non-inferiority margin of 0.3%.|Difference in LS Means|0.19|||||TWO_SIDED|98.34|0.02|0.36||||||Pairwise Comparison||0.36|0.02|
72424865|NCT01709305|144360674|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority criterion are met when the upper limit of the two-sided 98.34% CI for the difference in LS means is less than or equal to the pre-specified non-inferiority margin of 0.3%.|Difference in LS Means|0.03|||||TWO_SIDED|98.34|-0.15|0.21||||||Pairwise Comparison||0.21|-0.15|
72424866|NCT01709305|144360674|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority criterion are met when the upper limit of the two-sided 98.34% CI for the difference in LS means is less than or equal to the pre-specified non-inferiority margin of 0.3%.|Difference in LS Means|-0.05|||||TWO_SIDED|98.34|-0.23|0.14||||||Pairwise Comparison||0.14|-0.23|
72424867|NCT01709305|144360676|SUPERIORITY_OR_OTHER||Estimate|-8.4|||<|0.001|TWO_SIDED|95.0|-11.1|-6.1|||Miettinen & Nurminen|||Difference in % vs. Glimepiride||-6.1|-11.1|<0.001
72424868|NCT01709305|144360676|SUPERIORITY_OR_OTHER||Estimate|-2.9||||0.072|TWO_SIDED|95.0|-6.1|0.3|||Miettinen & Nurminen|||Difference in % vs. Glimepiride||0.3|-6.1|0.072
72424869|NCT01709305|144360676|SUPERIORITY_OR_OTHER||Estimate|-5.3|||<|0.001|TWO_SIDED|95.0|-8.3|-2.5|||Miettinen & Nurminen|||Difference in % vs. Glimepiride||-2.5|-8.3|<0.001
72424870|NCT01709305|144360677|SUPERIORITY_OR_OTHER||Estimate|0.4||||0.158|TWO_SIDED|95.0|-0.3|1.3|||Miettinen & Nurminen|||Difference in % vs. Glimepiride||1.3|-0.3|0.158
72424871|NCT01709305|144360677|SUPERIORITY_OR_OTHER||Estimate|0.0|||>|0.999|TWO_SIDED|95.0|-0.7|0.7|||Miettinen & Nurminen|||Difference in % vs. Glimepiride||0.7|-0.7|>0.999
72424872|NCT01709305|144360677|SUPERIORITY_OR_OTHER||Estimate|0.2||||0.318|TWO_SIDED|95.0|-0.5|1.0|||Miettinen & Nurminen|||Difference in % vs. Glimepiride||1.0|-0.5|0.318
72424873|NCT01709305|144360678|SUPERIORITY_OR_OTHER||Estimate|0.0||||0.998|TWO_SIDED|95.0|-0.9|0.9|||Miettinen & Nurminen|||Difference in % vs. Glimepiride||0.9|-0.9|0.998
72424874|NCT01709305|144360678|SUPERIORITY_OR_OTHER||Estimate|-0.2||||0.319|TWO_SIDED|95.0|-1.0|0.5|||Miettinen & Nurminen|||Difference in % vs. Glimepiride||0.5|-1.0|0.319
72424875|NCT01709305|144360678|SUPERIORITY_OR_OTHER||Estimate|0.0||||0.999|TWO_SIDED|95.0|-0.9|0.9|||Miettinen & Nurminen|||Difference in % vs. Glimepiride||0.9|-0.9|0.999
72424876|NCT01709305|144360679|SUPERIORITY_OR_OTHER||Estimate|-0.2||||0.651|TWO_SIDED|95.0|-1.3|0.8|||Miettinen & Nurminen|||Difference in % vs. Glimepiride||0.8|-1.3|0.651
72424877|NCT01709305|144360679|SUPERIORITY_OR_OTHER||Estimate|-0.2||||0.66|TWO_SIDED|95.0|-1.3|0.8|||Miettinen & Nurminen|||Difference in % vs. Glimepiride||0.8|-1.3|0.660
72424878|NCT01709305|144360679|SUPERIORITY_OR_OTHER||Estimate|0.4||||0.48|TWO_SIDED|95.0|-0.8|1.6|||Miettinen & Nurminen|||Difference in % vs. Glimepiride||1.6|-0.8|0.480
72424879|NCT01709305|144360680|SUPERIORITY_OR_OTHER||Estimate|0.4||||0.158|TWO_SIDED|95.0|-0.3|1.3|||Miettinen & Nurminen|||Difference in % vs. Glimepiride||1.3|-0.3|0.158
72424880|NCT01709305|144360680|SUPERIORITY_OR_OTHER||Estimate|0.0|||>|0.999|TWO_SIDED|95.0|-0.7|0.7|||Miettinen & Nurminen|||Difference in % vs. Glimepiride||0.7|-0.7|>0.999
72424881|NCT01709305|144360680|SUPERIORITY_OR_OTHER||Estimate|0.2||||0.318|TWO_SIDED|95.0|-0.5|1.0|||Miettinen & Nurminen|||Difference in % vs. Glimepiride||1.0|-0.5|0.318
72424882|NCT00552786|144360809|SUPERIORITY_OR_OTHER||||||<|0.05||95.0||||Two-sided|ANOVA|Assessing the bioequivalence on temporary threshold shift at3k,4k,6k Hz between NAC and Placebo was carried out using ANOVA for 2×2 crossover design.||||||<0.05
72424883|NCT00552786|144360810|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||ANOVA|Assessing the bioequivalence on temporary threshold shift at 3k,4k,6k Hz between NAC and Placebo was carried out using ANOVA for 2×2 crossover design.||||||<0.05
72334150|NCT01559259|144191645|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|1.85||||0.71|TWO_SIDED|95.0|-7.82|11.53||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||8 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||11.53|-7.82|0.710
72334151|NCT01559259|144191645|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|3.99||||0.416|TWO_SIDED|95.0|-5.52|13.49||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||8 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||13.49|-5.52|0.416
72334152|NCT01559259|144191645|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|74.38|||<|0.001|TWO_SIDED|95.0|59.56|89.2||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||9 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||89.20|59.56|<0.001
72334153|NCT01559259|144191645|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|71.59|||<|0.001|TWO_SIDED|95.0|56.61|86.57||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||9 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||86.57|56.61|<0.001
72334154|NCT01559259|144191645|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|73.24|||<|0.001|TWO_SIDED|95.0|58.18|88.3||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||9 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||88.30|58.18|<0.001
72334155|NCT01559259|144191645|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|69.21|||<|0.001|TWO_SIDED|95.0|53.86|84.56||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||9 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||84.56|53.86|<0.001
72334156|NCT01559259|144191645|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|5.25||||0.265|TWO_SIDED|95.0|-3.92|14.41||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||9 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||14.41|-3.92|0.265
72334157|NCT01559259|144191645|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|1.85||||0.71|TWO_SIDED|95.0|-7.82|11.53||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||9 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||11.53|-7.82|0.710
72334158|NCT01559259|144191645|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|3.99||||0.416|TWO_SIDED|95.0|-5.52|13.49||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||9 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||13.49|-5.52|0.416
72334159|NCT01559259|144191645|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|71.1|||<|0.001|TWO_SIDED|95.0|55.82|86.38||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||10 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||86.38|55.82|<0.001
72334160|NCT01559259|144191645|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|68.31|||<|0.001|TWO_SIDED|95.0|52.88|83.74||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||10 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||83.74|52.88|<0.001
72334161|NCT01559259|144191645|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|69.98|||<|0.001|TWO_SIDED|95.0|54.47|85.48||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||10 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||85.48|54.47|<0.001
72334162|NCT01559259|144191645|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|65.95|||<|0.001|TWO_SIDED|95.0|50.16|81.74||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||10 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||81.74|50.16|<0.001
72424884|NCT03549234|144360812|NON_INFERIORITY|"We tested the noninferiority of ESPB compared to PVB (paravertebral block) using the 95% confidence interval (CI) associated with the Wilcoxon-Mann-Whitney Exact test. If the lower limit of the 95% CI for median average recovery room pain scores was greater than -1.25 (based on PVB minus ESPB), we concluded noninferiority. The noninferiority of ESPBs with regard to opioid consumption was similarly tested with a predefined noninferiority margin of 2 mg intravenous morphine equivalents."||||||0.0011|||||||Wilcoxon (Mann-Whitney)|||We hypothesized that 1) analgesia would be noninferior in the recovery room as measured on a Numeric Rating Scale with ESPB (erector spinae plane block), and 2) opioid consumption would be noninferior in the operating and recovery rooms with ESPB. We simulated pain scores from a discrete distribution with median (interquartile range) 2 (0-3). The sample size of 50 per group provided 81% power to detect noninferiority in pain.||||0.0011
72424885|NCT03549234|144360813|NON_INFERIORITY|"We tested the noninferiority of ESPB compared to PVB using the 95% confidence interval (CI) associated with the Wilcoxon-Mann-Whitney Exact test. If the lower limit of the 95% CI for median average recovery room pain scores was greater than -1.25 (based on PVB minus ESPB), we concluded noninferiority. The noninferiority of ESPBs with regard to opioid consumption was similarly tested with a predefined noninferiority margin of 2 mg intravenous morphine equivalents."||||||0.0043|||||||Wilcoxon (Mann-Whitney)|||||||0.0043
72424886|NCT01265030|144360818|SUPERIORITY||Mean Difference (Net)|0.75||||0.63|TWO_SIDED|95.0|-2.54|4.04|||t-test, 2 sided|||||4.04|-2.54|0.63
72424887|NCT01265030|144360818|SUPERIORITY||Mean Difference (Net)|-1.95||||0.31|TWO_SIDED|95.0|-6.08|2.19|||t-test, 2 sided|||||2.19|-6.08|0.31
72424888|NCT01265030|144360819|SUPERIORITY||Mean Difference (Net)|0.063||||0.68|TWO_SIDED|95.0|-0.286|0.411|||t-test, 2 sided|||The mean difference in pain score at week 1 and before surgery||0.411|-.286|0.68
72424889|NCT01590771|144360822|SUPERIORITY_OR_OTHER||Robust regression|-0.61|||<|0.001|TWO_SIDED|95.0|-0.77|-0.44||The ANCOVA model controlled for treatment, metformin strata (on or not on metformin), and baseline A1C value.|ANCOVA||Based on robust regression using M-estimation with terms for treatment, metformin strata (on or not on metformin), and baseline A1C value.|||-0.44|-0.77|<0.001
72424890|NCT01590771|144360823|SUPERIORITY_OR_OTHER||Difference in least squares mean|-32.9|||<|0.001|TWO_SIDED|95.0|-45.4|-20.4||The ANCOVA model controlled for treatment, metformin strata (on or not on metformin), and baseline 2-hr PMG value.|ANCOVA|||||-20.4|-45.4|<0.001
72424891|NCT01590771|144360824|SUPERIORITY_OR_OTHER||Estimate difference|-16.8|||<|0.001|TWO_SIDED|95.0|-23.3|-10.2||Based on robust regression using M-estimation with terms for treatment, metformin strata (on or not on metformin), and baseline FPG value.|Robust regression|||||-10.2|-23.3|<0.001
72334163|NCT01559259|144191645|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|5.25||||0.265|TWO_SIDED|95.0|-3.92|14.41||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||10 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||14.41|-3.92|0.265
72334164|NCT01559259|144191645|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|1.85||||0.71|TWO_SIDED|95.0|-7.82|11.53||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||10 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||11.53|-7.82|0.710
72334165|NCT01559259|144191645|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|3.99||||0.416|TWO_SIDED|95.0|-5.52|13.49||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||10 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||13.49|-5.52|0.416
72334166|NCT01559259|144191645|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|71.1|||<|0.001|TWO_SIDED|95.0|55.82|86.38||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||11 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||86.38|55.82|<0.001
72334167|NCT01559259|144191645|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|68.31|||<|0.001|TWO_SIDED|95.0|52.88|83.74||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||11 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||83.74|52.88|<0.001
72334168|NCT01559259|144191645|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|69.98|||<|0.001|TWO_SIDED|95.0|54.47|85.48||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||11 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||85.48|54.47|<0.001
72334169|NCT01559259|144191645|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|65.95|||<|0.001|TWO_SIDED|95.0|50.16|81.74||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||11 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||81.74|50.16|<0.001
72334170|NCT01559259|144191645|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|5.25||||0.265|TWO_SIDED|95.0|-3.92|14.41||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||11 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||14.41|-3.92|0.265
72369433|NCT03894813|144248843|NON_INFERIORITY|The relevant parameters were determined as follows: test level α=0.05, test power 1-β=0.80, Pt=0.90, Pc=0.75, Nt:Nc=1:1, boundary value Δ= -0.0.068 (excellent), and Fisher's exact test. As a result, the sample size of each group was calculated as 50 patients, 100 patients in total. Considering a loss to follow-up rate of 20%, a sample size of 120 patients was finally determined, with 60 patients in each group.|||||<|0.01|||||||Chi-squared|||||||<0.01
72369434|NCT02656693|144248918|SUPERIORITY|||||||0.00017|||||||Mixed Models Analysis|||||||0.00017
72369435|NCT02656693|144248920|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||< 0.001
72369436|NCT02656693|144248922|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||< 0.001
72369437|NCT02656693|144248923|SUPERIORITY|||||||0.01|||||||Mixed Models Analysis|||||||0.01
72369438|NCT02656693|144248925|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
72369439|NCT02656693|144248926|SUPERIORITY|||||||0.2|||||||Mixed Models Analysis|||||||0.20
72369440|NCT02656693|144248927|SUPERIORITY|||||||0.0001|||||||Mixed Models Analysis|||||||0.0001
72334171|NCT01559259|144191645|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|1.85||||0.71|TWO_SIDED|95.0|-7.82|11.53||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||11 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||11.53|-7.82|0.710
72334172|NCT01559259|144191645|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|3.99||||0.416|TWO_SIDED|95.0|-5.52|13.49||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||11 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||13.49|-5.52|0.416
72334173|NCT01559259|144191645|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|71.1|||<|0.001|TWO_SIDED|95.0|55.82|86.38||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||12 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||86.38|55.82|<0.001
72334174|NCT01559259|144191645|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|68.31|||<|0.001|TWO_SIDED|95.0|52.88|83.74||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||12 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||83.74|52.88|<0.001
72334175|NCT01559259|144191645|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|69.98|||<|0.001|TWO_SIDED|95.0|54.47|85.48||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||12 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||85.48|54.47|<0.001
72369441|NCT02656693|144248928|SUPERIORITY|||||||0.19|||||||Mixed Models Analysis|||||||0.19
72369442|NCT02656693|144248929|SUPERIORITY|||||||0.35|||||||Mixed Models Analysis|||||||0.35
72369443|NCT02656693|144248930|SUPERIORITY|||||||0.2|||||||Mixed Models Analysis|||||||0.20
72424892|NCT01590771|144360825|SUPERIORITY_OR_OTHER||Difference in least squares mean|-0.41|||<|0.001|TWO_SIDED|95.0|-0.63|-0.2||The ANCOVA model controlled for treatment and baseline A1C value.|ANCOVA|||||-0.20|-0.63|<0.001
72424893|NCT01590771|144360826|SUPERIORITY_OR_OTHER||Difference in least squares mean|-0.8|||<|0.001|TWO_SIDED|95.0|-1.07|-0.53||The ANCOVA model controlled for treatment and baseline A1C value.|ANCOVA|||||-0.53|-1.07|<0.001
72424894|NCT01590771|144360827|SUPERIORITY_OR_OTHER||Estimate difference|-27.2|||<|0.001|TWO_SIDED|95.0|-41.2|-13.2||Based on robust regression using M-estimation with terms for treatment and baseline 2-hr PMG value.|Robust regression|||||-13.2|-41.2|<0.001
72334176|NCT01559259|144191645|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|65.95|||<|0.001|TWO_SIDED|95.0|50.16|81.74||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||12 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||81.74|50.16|<0.001
72369444|NCT02656693|144248931|SUPERIORITY|||||||0.33|||||||Mixed Models Analysis|||||||0.33
72369445|NCT02656693|144248932|SUPERIORITY|||||||0.43|||||||Mixed Models Analysis|||||||0.43
72369446|NCT02656693|144248933|SUPERIORITY|||||||0.4|||||||Mixed Models Analysis|||||||0.40
72369447|NCT02656693|144248934|SUPERIORITY|||||||0.16|||||||Mixed Models Analysis|||||||0.16
72424895|NCT01590771|144360828|SUPERIORITY_OR_OTHER||Difference in least squares mean|-37.7|||<|0.001|TWO_SIDED|95.0|-56.9|-18.4||The ANCOVA model controlled for treatment and baseline 2-hr PMG value.|ANCOVA|||||-18.4|-56.9|<0.001
72424896|NCT01590771|144360829|SUPERIORITY_OR_OTHER||Estimate Difference|-16.5|||<|0.001|TWO_SIDED|95.0|-25.3|-7.8||Based on robust regression using M-estimation with terms for treatment and baseline FPG value.|Robust Regression|||||-7.8|-25.3|<0.001
72424897|NCT01590771|144360830|SUPERIORITY_OR_OTHER||Estimate Difference|-17.0|||<|0.001|TWO_SIDED|95.0|-26.9|-7.1||Based on robust regression using M-estimation with terms for treatment and baseline FPG value.|Robust Regression|||||-7.1|-26.9|<0.001
72424898|NCT04022889|144360833|NON_INFERIORITY|The null hypothesis of inferiority was to be rejected in favor of the alternative hypothesis of non-inferiority at the two-sided 0.05 significance level if the lower bound of a two-sided 95% CI for the mean treatment difference (Test - 0.66 × Control) was greater than or equal to zero.|Mean Difference (Final Values)|1.4|STANDARD_DEVIATION|7.7|||TWO_SIDED|95.0|-3.5|6.2|||||The mean treatment difference is defined as Test recovery - (0.66 × Control recovery).|||6.2|-3.5|
72424899|NCT04022889|144360833|NON_INFERIORITY|The null hypothesis of inferiority was to be rejected in favor of the alternative hypothesis of non-inferiority at the two-sided 0.05 significance level if the lower bound of a two-sided 95% CI for the mean treatment difference (Test - 0.66 × Control) was greater than or equal to zero.|Mean Difference (Final Values)|-0.8|STANDARD_DEVIATION|8.9|||TWO_SIDED|95.0|-6.4|4.8|||||The mean treatment difference is defined as Test recovery - (0.66 × Control recovery).|||4.8|-6.4|
72424900|NCT04022889|144360833|OTHER|Variant 1-BEST = Test Variant 1 Endpoint - Test BEST Endpoint|Mean Difference (Final Values)|1.8|STANDARD_DEVIATION|10.2|||TWO_SIDED|95.0|-5.0|8.7|||||The mean treatment difference is defined as Test recovery - (0.66 × Control recovery).|||8.7|-5.0|
72424901|NCT04022889|144360833|NON_INFERIORITY|The null hypothesis of inferiority was to be rejected in favor of the alternative hypothesis of non-inferiority at the two-sided 0.05 significance level if the lower bound of a two-sided 95% CI for the mean treatment difference (Test - 0.66 × Control) was greater than or equal to zero.|Mean Difference (Final Values)|0.1|STANDARD_DEVIATION|5.9|||TWO_SIDED|95.0|-2.5|2.6|||||The mean treatment difference is defined as Test recovery - (0.66 × Control recovery).|||2.6|-2.5|
72424902|NCT04022889|144360834|NON_INFERIORITY|The null hypothesis of inferiority was to be rejected in favor of the alternative hypothesis of non-inferiority at the two-sided 0.05 significance level if the lower bound of a two-sided 95% CI for the mean treatment difference (Test - 0.58 × Control) was greater than or equal to zero.|Mean Difference (Final Values)|28.9|STANDARD_DEVIATION|16.5|||TWO_SIDED|95.0|18.5|39.4|||||The mean treatment difference is defined as Test survival - (0.58 × Control survival).|||39.4|18.5|
72424903|NCT04022889|144360834|NON_INFERIORITY|The null hypothesis of inferiority was to be rejected in favor of the alternative hypothesis of non-inferiority at the two-sided 0.05 significance level if the lower bound of a two-sided 95% CI for the mean treatment difference (Test - 0.58 × Control) was greater than or equal to zero.|Mean Difference (Final Values)|25.5|STANDARD_DEVIATION|25.3|||TWO_SIDED|95.0|9.5|41.6|||||The mean treatment difference is defined as Test survival - (0.58 × Control survival).|||41.6|9.5|
72424904|NCT04022889|144360834|EQUIVALENCE|Variant 1-BEST = Test Variant 1 Endpoint - Test BEST Endpoint|Mean Difference (Final Values)|1.6|STANDARD_DEVIATION|21.3|||TWO_SIDED|95.0|-12.7|15.8|||||The mean treatment difference is defined as Test survival - (0.58 × Control survival).|||15.8|-12.7|
72424905|NCT04022889|144360834|NON_INFERIORITY|The null hypothesis of inferiority was to be rejected in favor of the alternative hypothesis of non-inferiority at the two-sided 0.05 significance level if the lower bound of a two-sided 95% CI for the mean treatment difference (Test - 0.58 × Control) was greater than or equal to zero.|Mean Difference (Final Values)|29.8|STANDARD_DEVIATION|18.5|||TWO_SIDED|95.0|21.8|37.8|||||The mean treatment difference is defined as Test survival - (0.58 × Control survival).|||37.8|21.8|
72424906|NCT00856934|144360880|SUPERIORITY_OR_OTHER|||||||0.05|||||||ANOVA|||||||0.05
72424907|NCT00856934|144360881|SUPERIORITY_OR_OTHER|||||||0.05|||||||ANOVA|||||||0.05
72424908|NCT02254408|144360972|SUPERIORITY||Treatment Difference|-0.33||||0.04|TWO_SIDED|95.0|-0.64|-0.02|||ANCOVA|||||-0.02|-0.64|0.040
72424909|NCT02254408|144360973|SUPERIORITY||Odds Ratio (OR)|0.5||||0.11|TWO_SIDED|95.0|0.22|1.18|||Cochran-Mantel-Haenszel|||||1.18|0.22|0.11
72424910|NCT02254408|144360973|SUPERIORITY|||||||0.15|||||||Fisher Exact|||||||0.15
72424911|NCT02254408|144360974|SUPERIORITY||Odds Ratio (OR)|1.01||||0.98|TWO_SIDED|95.0|0.28|3.63|||Cochran-Mantel-Haenszel|||||3.63|0.28|0.98
72424912|NCT02254408|144360974|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.00
72424913|NCT02914184|144360975|OTHER|The two-sided 95% CIs for the ratio of anti RV IgA antibody GMCs should be within the \[0.5; 2\] clinical limit interval.|GMC Ratio at At Month 2-4|1.07|||||TWO_SIDED|95.0|0.79|1.44|||ANOVA|||GMC Ratio of Anti-RV IgA antibody for Liq\_A and Liq\_B groups was calculated using ANOVA model with vaccine groups and country as fixed effects.||1.44|0.79|
72424914|NCT02914184|144360975|OTHER|The two-sided 95% CIs for the ratio of anti RV IgA antibody GMCs should be within the \[0.5; 2\] clinical limit interval.|GMC Ratio at At Month 2-4|0.88|||||TWO_SIDED|95.0|0.65|1.19|||ANOVA|||GMC Ratio of Anti-RV IgA antibody for Liq\_A and Liq\_C groups was calculated using ANOVA model with vaccine groups and country as fixed effects.||1.19|0.65|
72334177|NCT01559259|144191645|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|5.25||||0.265|TWO_SIDED|95.0|-3.92|14.41||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||12 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||14.41|-3.92|0.265
72369448|NCT02656693|144248935|SUPERIORITY|||||||0.61|||||||Mixed Models Analysis|||||||0.61
72334178|NCT01559259|144191645|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|1.85||||0.71|TWO_SIDED|95.0|-7.82|11.53||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||12 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||11.53|-7.82|0.710
72334179|NCT01559259|144191645|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|3.99||||0.416|TWO_SIDED|95.0|-5.52|13.49||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||12 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||13.49|-5.52|0.416
72334180|NCT01559259|144191646|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|23.99||||0.003|TWO_SIDED|95.0|13.32|34.67||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||0.25 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||34.67|13.32|0.003
72369449|NCT02656693|144248936|SUPERIORITY|||||||0.61|||||||Mixed Models Analysis|||||||0.61
72369450|NCT02656693|144248937|SUPERIORITY|||||||0.46|||||||Mixed Models Analysis|||||||0.46
72369451|NCT02656693|144248938|SUPERIORITY|||||||0.68|||||||Mixed Models Analysis|||||||0.68
72424915|NCT02914184|144360975|OTHER|The two-sided 95% CIs for the ratio of anti RV IgA antibody GMCs should be within the \[0.5; 2\] clinical limit interval.|GMC Ratio at At Month 2-4|0.82|||||TWO_SIDED|95.0|0.61|1.11|||ANOVA|||GMC Ratio of Anti-RV IgA antibody for Liq\_B and Liq\_C groups was calculated using ANOVA model with vaccine groups and country as fixed effects.||1.11|0.61|
72424916|NCT02914184|144360976|NON_INFERIORITY|Lower limit (LL) of the two-sided asymptotic standardized 95% CI for the difference in SCR for antibodies to rota virus at month 2-4 between the Liq\_Pool group and Lyo Control group should be ≥ -10%.|SCR difference at Month 2-4|-2.49|||||TWO_SIDED|95.0|-7.15|2.63||||||Non-inferiority of Liq\_Pool group compared to Lyo Control group in terms of difference in % of subjects with anti-RV IgA titer ≥ specified cut off with its 2-sided 95% CI in initially seronegative subjects||2.63|-7.15|
72424917|NCT02914184|144360978|NON_INFERIORITY|LL of the two-sided 95% CI for the ratio of anti-RV IgA antibody GMCs between the Liq\_Pool Group and Control group should be ≥ 0.67.|GMC Ratio at At Month 2-4|1.04|||||TWO_SIDED|95.0|0.82|1.33|||ANOVA|||Non-inferiority of Liq\_Pool Group as compared to Lyo Control group in terms of the GMC ratio calculated using ANOVA model with vaccine groups and country as fixed effects||1.33|0.82|
72424918|NCT00798174|144360985|SUPERIORITY|The null hypothesis was that the azygos coil does not reduce the DFT. (A reduced DFT is superiority).||||||0.103||||||Threshold for significance is 0.05.|t-test, 2 sided|Paired t-test||"The null hypothesis is that there is no difference between the DFT using the azygos coil vs. the standard configuration.~Paired t-test (two-tailed), used due to construction of study with DFT determined in both configurations in each patient, yields p=0.103"||||0.103
72334181|NCT01559259|144191646|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|14.83||||0.048|TWO_SIDED|95.0|4.59|25.07||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||0.25 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||25.07|4.59|0.048
72424919|NCT01118455|144360997|SUPERIORITY_OR_OTHER|||||||0.507|||||||Cochran-Mantel-Haenszel|||||||0.507
72424920|NCT01118455|144360997|SUPERIORITY_OR_OTHER|||||||0.22||95.0|||||Cochran-Mantel-Haenszel|||||||0.220
72424921|NCT01118455|144360997|SUPERIORITY_OR_OTHER|||||||0.168||95.0|||||Cochran-Mantel-Haenszel|||||||0.168
72424922|NCT01118455|144360997|SUPERIORITY_OR_OTHER|||||||0.62||95.0|||||Cochran-Mantel-Haenszel|||||||0.620
72424923|NCT01118455|144360998|SUPERIORITY_OR_OTHER|||||||0.727|||||||Wilcoxon (Mann-Whitney)|||||||0.727
72424924|NCT01118455|144360998|SUPERIORITY_OR_OTHER|||||||0.217|||||||Wilcoxon (Mann-Whitney)|||||||0.217
72424925|NCT01118455|144360998|SUPERIORITY_OR_OTHER|||||||0.27|||||||Wilcoxon (Mann-Whitney)|||||||0.270
72424926|NCT01118455|144360998|SUPERIORITY_OR_OTHER|||||||0.036|||||||Wilcoxon (Mann-Whitney)|||||||0.036
72424927|NCT01118455|144360999|SUPERIORITY_OR_OTHER|||||||0.448||95.0|||||t-test, 2 sided|||||||0.448
72424928|NCT01118455|144360999|SUPERIORITY_OR_OTHER|||||||0.025||95.0|||||t-test, 2 sided|||||||0.025
72424929|NCT01118455|144360999|SUPERIORITY_OR_OTHER|||||||0.799|||||||t-test, 2 sided|||||||0.799
72424930|NCT01118455|144360999|SUPERIORITY_OR_OTHER|||||||0.142|||||||t-test, 2 sided|||||||0.142
72424931|NCT01118455|144361000|SUPERIORITY_OR_OTHER|||||||0.714||95.0|||||t-test, 2 sided|||||||0.714
72424932|NCT01118455|144361000|SUPERIORITY_OR_OTHER|||||||0.426||95.0|||||t-test, 2 sided|||||||0.426
72424933|NCT01118455|144361000|SUPERIORITY_OR_OTHER|||||||0.467|||||||t-test, 2 sided|||||||0.467
72334182|NCT01559259|144191646|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|24.98||||0.005|TWO_SIDED|95.0|13.43|36.53||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||0.25 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||36.53|13.43|0.005
72334183|NCT01559259|144191646|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|16.57||||0.03|TWO_SIDED|95.0|6.25|26.88||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||0.25 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||26.88|6.25|0.030
72334184|NCT01559259|144191646|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|6.86||||0.269|TWO_SIDED|95.0|-4.8|18.53||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||0.25 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||18.53|-4.80|0.269
72334185|NCT01559259|144191646|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-1.95||||0.735|TWO_SIDED|95.0|-13.34|9.43||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||0.25 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||9.43|-13.34|0.735
72334186|NCT01559259|144191646|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|8.58||||0.176|TWO_SIDED|95.0|-3.88|21.04||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||0.25 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||21.04|-3.88|0.176
72334187|NCT01559259|144191646|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|63.3|||<|0.001|TWO_SIDED|95.0|49.07|77.52||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||0.5 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||77.52|49.07|<0.001
72334188|NCT01559259|144191646|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|56.81|||<|0.001|TWO_SIDED|95.0|42.28|71.34||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||0.5 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||71.34|42.28|<0.001
72334189|NCT01559259|144191646|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|67.57|||<|0.001|TWO_SIDED|95.0|53.58|81.55||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||0.5 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||81.55|53.58|<0.001
72334190|NCT01559259|144191646|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|53.31|||<|0.001|TWO_SIDED|95.0|38.62|67.99||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||0.5 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||67.99|38.62|<0.001
72334191|NCT01559259|144191646|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|10.28||||0.14|TWO_SIDED|95.0|-3.26|23.82||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||0.5 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||23.82|-3.26|0.140
72334192|NCT01559259|144191646|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|2.98||||0.674|TWO_SIDED|95.0|-10.94|16.89||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||0.5 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||16.89|-10.94|0.674
72334193|NCT01559259|144191646|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|14.58||||0.034|TWO_SIDED|95.0|1.22|27.93||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||0.5 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||27.93|1.22|0.034
72369452|NCT02656693|144248939|SUPERIORITY|||||||0.54|||||||Mixed Models Analysis|||||||0.54
72424934|NCT01118455|144361000|SUPERIORITY_OR_OTHER|||||||0.654|||||||t-test, 2 sided|||||||0.654
72424935|NCT01118455|144361001|SUPERIORITY_OR_OTHER|||||||0.691|||||||ANOVA|||||||0.691
72424936|NCT01118455|144361001|SUPERIORITY_OR_OTHER|||||||0.494|||||||ANOVA|||||||0.494
72369453|NCT02656693|144248940|SUPERIORITY|||||||0.09|||||||Mixed Models Analysis|||||||0.09
72369454|NCT02656693|144248941|SUPERIORITY|||||||0.42|||||||Mixed Models Analysis|||||||0.42
72369455|NCT02656693|144248942|SUPERIORITY|||||||0.23|||||||Mixed Models Analysis|||||||0.23
72369456|NCT02656693|144248943|SUPERIORITY|||||||0.2|||||||Mixed Models Analysis|||||||0.20
72369457|NCT02082119|144248981|OTHER||||||<|0.05|||||||t-test, 1 sided|||||||<0.05
72369458|NCT02642315|144249018|OTHER||Median Difference (Net)|36.0||||0.0131|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.0131
72369459|NCT02642315|144249019|OTHER||Median Difference (Net)|36.0||||0.0131|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.0131
72334194|NCT01559259|144191646|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|72.32|||<|0.001|TWO_SIDED|95.0|58.25|86.39||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||1 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||86.39|58.25|<0.001
72424937|NCT01118455|144361001|SUPERIORITY_OR_OTHER|||||||0.343|||||||ANOVA|||||||0.343
72424938|NCT01118455|144361001|SUPERIORITY_OR_OTHER|||||||0.295|||||||ANOVA|||||||0.295
72334195|NCT01559259|144191646|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|67.2|||<|0.001|TWO_SIDED|95.0|52.63|81.78||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||1 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||81.78|52.63|<0.001
72334196|NCT01559259|144191646|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|72.4|||<|0.001|TWO_SIDED|95.0|58.4|86.4||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||1 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||86.40|58.40|<0.001
72334197|NCT01559259|144191646|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|64.12|||<|0.001|TWO_SIDED|95.0|49.32|78.91||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||1 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||78.91|49.32|<0.001
72334198|NCT01559259|144191646|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|8.4||||0.119|TWO_SIDED|95.0|-2.06|18.85||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||1 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||18.85|-2.06|0.119
72334199|NCT01559259|144191646|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|2.84||||0.616|TWO_SIDED|95.0|-8.3|13.98||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||1 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||13.98|-8.30|0.616
72334200|NCT01559259|144191646|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|8.34||||0.125|TWO_SIDED|95.0|-2.2|18.87||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||1 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||18.87|-2.20|0.125
72334201|NCT01559259|144191646|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|74.49|||<|0.001|TWO_SIDED|95.0|60.73|88.25||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||1.5 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||88.25|60.73|<0.001
72424939|NCT02674490|144361035|SUPERIORITY|||||||0.54||||||Threshold for significance is two-sided alpha of 0.05.|Regression, Linear|The primary analysis was adjusted for aphasia type (Anomia, Broca, or other type), baseline aphasia severity (AQ), and age.||Sample Size Determination If sample size in each group is 20, we will have 89% power to detect a difference in means of 23 (the difference between A-tDCS mean change in accuracy of 33 and a sham mean change in accuracy of 10) assuming that the SD of change for both groups is 22.2 using a two group t-test with a two-sided alpha of 0.05.||||0.54
72424940|NCT03810313|144361047|NON_INFERIORITY|Non-inferiority was considered to be established if the lower limit of the corresponding 95% CI for the estimated between group difference (brolucizumab vs. aflibercept) on change from baseline in BCVA at Week 24 is \> -4 letters.|Least Square Mean Difference|-2.9|STANDARD_ERROR_OF_MEAN|1.2||0.173|TWO_SIDED|95.0|-5.2|-0.5|||ANOVA|||||-0.5|-5.2|0.173
72334202|NCT01559259|144191646|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|69.38|||<|0.001|TWO_SIDED|95.0|55.05|83.71||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||1.5 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||83.71|55.05|<0.001
72334203|NCT01559259|144191646|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|73.52|||<|0.001|TWO_SIDED|95.0|59.65|87.38||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||1.5 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||87.38|59.65|<0.001
72334204|NCT01559259|144191646|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|68.36|||<|0.001|TWO_SIDED|95.0|54.01|82.71||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||1.5 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||82.71|54.01|<0.001
72334205|NCT01559259|144191646|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|6.33||||0.187|TWO_SIDED|95.0|-2.99|15.65||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||1.5 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||15.65|-2.99|0.187
72334206|NCT01559259|144191646|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|0.79||||0.881|TWO_SIDED|95.0|-9.42|10.99||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||1.5 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||10.99|-9.42|0.881
72334207|NCT01559259|144191646|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|5.05||||0.311|TWO_SIDED|95.0|-4.6|14.71||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||1.5 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||14.71|-4.60|0.311
72334208|NCT01559259|144191646|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|71.1|||<|0.001|TWO_SIDED|95.0|55.82|86.38||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||2 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||86.38|55.82|<0.001
72424941|NCT03029780|144361073|SUPERIORITY||DIFFERENCE IN INCIDENCE RATES|0.0|||||TWO_SIDED|95.0|-12.3|12.3||||||||12.3|-12.3|
72424942|NCT03029780|144361073|SUPERIORITY||Odds Ratio (OR)|1.0|||||TWO_SIDED|95.0|0.3|3.39|||Cochran-Mantel-Haenszel|||||3.39|0.30|
72424943|NCT03029780|144361074|SUPERIORITY||DIFFERENCE IN INCIDENCE RATES|0.0|||||TWO_SIDED|95.0|0.0|0.0||||||||0.00|0.00|
72424944|NCT03029780|144361075|SUPERIORITY||DIFFERENCE IN INCIDENCE RATES|5.8|||||TWO_SIDED|95.0|-13.3|24.8||||||||24.8|-13.3|
72424945|NCT03029780|144361075|SUPERIORITY||Odds Ratio (OR)|1.27|||||TWO_SIDED|95.0|0.58|2.78|||Cochran-Mantel-Haenszel|||||2.78|0.58|
72424946|NCT03029780|144361076|SUPERIORITY||DIFFERENCE IN INCIDENCE RATES|7.7|||||TWO_SIDED|95.0|-10.1|25.5||||||||25.5|-10.1|
72424947|NCT03029780|144361076|SUPERIORITY||Odds Ratio (OR)|1.42|||||TWO_SIDED|95.0|0.62|3.24|||Cochran-Mantel-Haenszel|||||3.24|0.62|
72334209|NCT01559259|144191646|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|68.31|||<|0.001|TWO_SIDED|95.0|52.88|83.74||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||2 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||83.74|52.88|<0.001
72334210|NCT01559259|144191646|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|69.98|||<|0.001|TWO_SIDED|95.0|54.47|85.48||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||2 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||85.48|54.47|<0.001
72334211|NCT01559259|144191646|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|65.95|||<|0.001|TWO_SIDED|95.0|50.16|81.74||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||2 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||81.74|50.16|<0.001
72334212|NCT01559259|144191646|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|5.25||||0.265|TWO_SIDED|95.0|-3.92|14.41||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||2 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||14.41|-3.92|0.265
72334213|NCT01559259|144191646|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|1.85||||0.71|TWO_SIDED|95.0|-7.82|11.53||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||2 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||11.53|-7.82|0.710
72424948|NCT01460160|144361084|SUPERIORITY||Estimate of Difference|16.86||||0.032|TWO_SIDED|90.0|3.9|29.8||Superiority test versus AIEOP-BFM 2000|Chi-squared||Treatment difference (CA180372 - AIEOP-BFM 2000)|Difference in 3-year binomial EFS rate in all treated participants (dasatinib plus chemotherapy) vs. chemotherapy alone in AIEOP-BFM 2000 historical control||29.8|3.9|0.032
72424949|NCT01460160|144361084|NON_INFERIORITY|non-inferiority margin = 5%. One-sided type I error rate of 0.05|Estimate of difference|6.91||||0.271|TWO_SIDED|90.0|-3.3|17.2||Superiority test versus EsPhALL|Chi-squared||Treatment difference (CA180372 - EsPhALL) Test if lower confidence limit is above -5%|Difference in 3-year binomial EFS rate for all treated participants (dasatinib plus chemotherapy) vs. continuous imatinib plus chemotherapy in the Amended EsPhALL Trial Historical Control||17.2|-3.3|0.271
72424950|NCT01460160|144361084|SUPERIORITY|Difference in 3-year binomial EFS rate in all treated participants (dasatinib plus chemotherapy) vs. chemotherapy alone in COG AALL0031 historical control|Estimate of difference|-10.75||||0.157|TWO_SIDED|90.0|-22.7|1.2|||Chi-squared||Treatment difference (CA180372 - COG AALL0031)|||1.2|-22.7|0.157
72334214|NCT01559259|144191646|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|3.99||||0.416|TWO_SIDED|95.0|-5.52|13.49||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||2 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||13.49|-5.52|0.416
72334215|NCT01559259|144191646|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|71.1|||<|0.001|TWO_SIDED|95.0|55.82|86.38||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||3 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||86.38|55.82|<0.001
72424951|NCT01616771|144361090|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|||||To verify the difference in C\&L grades using each blade, the ordinal scales of each blade were compared using the Wilcoxon signed rank test. P values and confidence intervals have been corrected for the 3 comparisons.|Wilcoxon (Mann-Whitney)|Hodges-Lehmann method was used to calculate 98.3% CIs of paired differences of 3 comparisons.||An improvement of C\&L grade ordinal scale by 2 was considered a clinically significant change. The mean difference of C\&L grade ordinal scale between DL and GVLw was 1.3, and its standard deviation was 2.0 in our pilot study. The required sample size for the Wilcoxon signed rank test was 21 with an α error of 0.05 and 80% power.||||<0.05
72424952|NCT01616771|144361091|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|||||To verify the difference in C\&L grades using each blade, the ordinal scales of each blade were compared using the Wilcoxon signed rank test. P values and confidence intervals have been corrected for the 3 comparisons.|Wilcoxon (Mann-Whitney)|Hodges-Lehmann method was used to calculate 98.3% CIs of paired differences of 3 comparisons.||An improvement of C\&L grade ordinal scale by 2 was considered a clinically significant change. The mean difference of C\&L grade ordinal scale between DL and GVLw was 1.3, and its standard deviation was 2.0 in our pilot study. The required sample size for the Wilcoxon signed rank test was 21 with an α error of 0.05 and 80% power.||||<0.05
72424953|NCT02387216|144361107|SUPERIORITY||Hazard Ratio (HR)|1.382||||0.2302|TWO_SIDED|95.0|0.813|2.35|||Log Rank|||||2.350|0.813|0.2302
72424954|NCT02387216|144361108|SUPERIORITY||Hazard Ratio (HR)|1.195||||0.5436|TWO_SIDED|95.0|0.673|2.122|||Log Rank|||||2.122|0.673|0.5436
72424955|NCT02387216|144361109|SUPERIORITY||Odds Ratio (OR)|4.3||||0.0455|TWO_SIDED|95.0|||||Cochran-Mantel-Haenszel|||||||0.0455
72424956|NCT02387216|144361110|SUPERIORITY|||||||0.2726|||||||Log Rank|||||||0.2726
72424957|NCT01381874|144361128|SUPERIORITY||Hazard Ratio (HR)|1.143||||0.437|TWO_SIDED|95.0|0.816|1.603|||stratified log-rank test|||||1.603|0.816|0.437
72334216|NCT01559259|144191646|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|68.31|||<|0.001|TWO_SIDED|95.0|52.88|83.74||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||3 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||83.74|52.88|<0.001
72334217|NCT01559259|144191646|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|69.98|||<|0.001|TWO_SIDED|95.0|54.47|85.48||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||3 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||85.48|54.47|<0.001
72424958|NCT01381874|144361128|SUPERIORITY||Hazard Ratio (HR)|0.958||||0.794|TWO_SIDED|95.0|0.695|1.32|||stratified log-rank test|||||1.320|0.695|0.794
72424959|NCT01381874|144361129|SUPERIORITY||Hazard Ratio (HR)|1.074||||0.807|TWO_SIDED|95.0|0.608|1.896|||stratified log-rank test|||||1.896|0.608|0.807
72424960|NCT01381874|144361129|SUPERIORITY||Hazard Ratio (HR)|1.183||||0.542|TWO_SIDED|95.0|0.688|2.036|||stratified log-rank test|||||2.036|0.688|0.542
72424961|NCT01381874|144361130|SUPERIORITY||Risk Ratio (RR)|0.909||||1|TWO_SIDED|95.0|0.213|3.878|||Fisher Exact|||||3.878|0.213|1.000
72424962|NCT01381874|144361130|SUPERIORITY||Risk Ratio (RR)|1.909||||0.366|TWO_SIDED|95.0|0.605|6.026|||Fisher Exact|||||6.026|0.605|0.366
72424963|NCT01381874|144361131|SUPERIORITY||Risk Ratio (RR)|0.757||||0.603|TWO_SIDED|95.0|0.264|2.175|||Chi-squared|||||2.175|0.264|0.603
72424964|NCT01381874|144361131|SUPERIORITY||Risk Ratio (RR)|1.79||||0.137|TWO_SIDED|95.0|0.816|3.926|||Chi-squared|||||3.926|0.816|0.137
72424965|NCT02247804|144361135|NON_INFERIORITY|MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.|Least-squares Mean Difference|-0.41|STANDARD_ERROR_OF_MEAN|0.39||0.295|TWO_SIDED|95.0|-1.17|0.36|||MMRM|||Change from Baseline Week 12, Hour 0: The null hypothesis was that bimatoprost SR 15 μg was to be declared non-inferior to timolol 0.5% if the upper limit of the 95% CI was ≤ 1.5 mm Hg for all scheduled timepoints (Hours 0 and 2 at Week 12).||0.36|-1.17|0.2950
72424966|NCT02247804|144361135|NON_INFERIORITY|MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.|Least-squares Mean Difference|-0.33|STANDARD_ERROR_OF_MEAN|0.39||0.3904|TWO_SIDED|95.0|-1.09|0.43|||MMRM|||Change from Baseline Week 12, Hour 0: The null hypothesis was that bimatoprost SR 10 μg was to be declared non-inferior to timolol 0.5% if the upper limit of the 95% CI was ≤ 1.5 mm Hg for all scheduled timepoints (Hours 0 and 2 at Week 12).||0.43|-1.09|0.3904
72424967|NCT02247804|144361135|NON_INFERIORITY|MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.|Least-squares Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.35||0.0464|TWO_SIDED|95.0|-1.4|-0.01|||MMRM|||Change from Baseline Week 12, Hour 2: The null hypothesis was that bimatoprost SR 15 μg was to be declared non-inferior to timolol 0.5% if the upper limit of the 95% CI was ≤ 1.5 mm Hg for all scheduled timepoints (Hours 0 and 2 at Week 12).||-0.01|-1.40|0.0464
72424968|NCT02247804|144361135|NON_INFERIORITY|MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.|Least-squares Mean Difference|-0.21|STANDARD_ERROR_OF_MEAN|0.35||0.5383|TWO_SIDED|95.0|-0.9|0.47|||MMRM|||Change from Baseline Week 12, Hour 2: The null hypothesis was that bimatoprost SR 10 μg was to be declared non-inferior to timolol 0.5% if the upper limit of the 95% CI was ≤ 1.5 mm Hg for all scheduled timepoints (Hours 0 and 2 at Week 12).||0.47|-0.90|0.5383
72424969|NCT02247804|144361136|NON_INFERIORITY|MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.|Least-squares Mean Difference|-1.01|STANDARD_ERROR_OF_MEAN|0.34||0.0033|TWO_SIDED|95.0|-1.68|-0.34|||MMRM|||Week 2, Hour 0: The null hypothesis was that bimatoprost SR 15 μg was to be declared non-inferior to timolol 0.5% if the upper limit of the 95% CI was ≤ 1.5 mm Hg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).||-0.34|-1.68|0.0033
72424970|NCT02247804|144361136|NON_INFERIORITY|MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.|Least-squares Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.34||0.0187|TWO_SIDED|95.0|-1.47|-0.13|||MMRM|||Week 2, Hour 0: The null hypothesis was that bimatoprost SR 10 μg was to be declared non-inferior to timolol 0.5% if the upper limit of the 95% CI was ≤ 1.5 mm Hg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).||-0.13|-1.47|0.0187
72424971|NCT02247804|144361137|NON_INFERIORITY|MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.|Least-squares Mean Difference|-0.85|STANDARD_ERROR_OF_MEAN|0.31||0.0057||95.0|-1.45|-0.25|||MMRM|||Week 2, Hour 2: The null hypothesis was that bimatoprost SR 15 μg was to be declared non-inferior to timolol 0.5% if the upper limit of the 95% CI was ≤ 1.5 mm Hg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).||-0.25|-1.45|0.0057
72424972|NCT02247804|144361137|NON_INFERIORITY|MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.|Least-squares Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|0.3||0.0031||95.0|-1.5|-0.31|||MMRM|||Week 2, Hour 2: The null hypothesis was that bimatoprost SR 10 μg was to be declared non-inferior to timolol 0.5% if the upper limit of the 95% CI was ≤ 1.5 mm Hg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).||-0.31|-1.50|0.0031
72424973|NCT02247804|144361138|NON_INFERIORITY|MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.|Least-squares Mean Difference|-0.63|STANDARD_ERROR_OF_MEAN|0.32||0.0547||95.0|-1.26|0.01|||MMRM|||Week 6, Hour 0: The null hypothesis was that bimatoprost SR 15 μg was to be declared non-inferior to timolol 0.5% if the upper limit of the 95% CI was ≤ 1.5 mm Hg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).||0.01|-1.26|0.0547
72424974|NCT02247804|144361138|NON_INFERIORITY|MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.|Least-squares Mean Difference|-0.82|STANDARD_ERROR_OF_MEAN|0.32||0.0107||95.0|-1.46|-0.19|||MMRM|||Week 6, Hour 0: The null hypothesis was that bimatoprost SR 10 μg was to be declared non-inferior to timolol 0.5% if the upper limit of the 95% CI was ≤ 1.5 mm Hg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).||-0.19|-1.46|0.0107
72424975|NCT02247804|144361139|NON_INFERIORITY|MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.|Least-squares Mean Difference|0.08|STANDARD_ERROR_OF_MEAN|0.32||0.086||95.0|-1.16|0.08|||MMRM|||Week 6, Hour 2: The null hypothesis was that bimatoprost SR 15 μg was to be declared non-inferior to timolol 0.5% if the upper limit of the 95% CI was ≤ 1.5 mm Hg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).||0.08|-1.16|0.0860
72334218|NCT01559259|144191646|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|65.95|||<|0.001|TWO_SIDED|95.0|50.16|81.74||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||3 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||81.74|50.16|<0.001
72424976|NCT02247804|144361139|NON_INFERIORITY|MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.|Least-squares Mean Difference|-0.66|STANDARD_ERROR_OF_MEAN|0.31||0.0362||95.0|-1.27|-0.04|||MMRM|||Week 6, Hour 2: The null hypothesis was that bimatoprost SR 10 μg was to be declared non-inferior to timolol 0.5% if the upper limit of the 95% CI was ≤ 1.5 mm Hg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).||-0.04|-1.27|0.0362
72424977|NCT02247804|144361140|NON_INFERIORITY|MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.|Least-squares Mean Difference|-0.41|STANDARD_ERROR_OF_MEAN|0.39||0.295||95.0|-1.17|0.36|||MMRM|||Week 12, Hour 0: The null hypothesis was that bimatoprost SR 15 μg was to be declared non-inferior to timolol 0.5% if the upper limit of the 95% CI was ≤ 1.5 mm Hg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).||0.36|-1.17|0.2950
72424978|NCT02247804|144361140|NON_INFERIORITY|MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.|Least-squares Mean Difference|-0.33|STANDARD_ERROR_OF_MEAN|0.39||0.3904|TWO_SIDED|95.0|-1.09|0.43|||MMRM|||Week 12, Hour 0: The null hypothesis was that bimatoprost SR 10 μg was to be declared non-inferior to timolol 0.5% if the upper limit of the 95% CI was ≤ 1.5 mm Hg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).||0.43|-1.09|0.3904
72334219|NCT01559259|144191646|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|5.25||||0.265|TWO_SIDED|95.0|-3.92|14.41||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||3 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||14.41|-3.92|0.265
72334220|NCT01559259|144191646|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|1.85||||0.71|TWO_SIDED|95.0|-7.82|11.53||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||3 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||11.53|-7.82|0.710
72424979|NCT02247804|144361141|NON_INFERIORITY|MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.|Least-squares Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.35||0.0464||95.0|-1.4|-0.01|||MMRM|||Week 12, Hour 2: The null hypothesis was that bimatoprost SR 15 μg was to be declared non-inferior to timolol 0.5% if the upper limit of the 95% CI was ≤ 1.5 mm Hg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).||-0.01|-1.40|0.0464
72424980|NCT02247804|144361141|NON_INFERIORITY|MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.|Least-squares Mean Difference|-0.21|STANDARD_ERROR_OF_MEAN|0.35||0.5383||95.0|-0.9|0.47|||MMRM|||Week 12, Hour 2: The null hypothesis was that bimatoprost SR 10 μg was to be declared non-inferior to timolol 0.5% if the upper limit of the 95% CI was ≤ 1.5 mm Hg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).||0.47|-0.90|0.5383
72424981|NCT02247804|144361142|SUPERIORITY|MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.|Least-squares Mean Difference|-1.01|STANDARD_ERROR_OF_MEAN|0.34||0.0033|TWO_SIDED|95.0|-1.68|-0.34|||MMRM|||Change from Baseline Week 2, Hour 0: The null hypothesis was that bimatoprost SR 10 μg was to be declared superior to timolol 0.5% if the upper limit of the 95% CI was \< 0 mm Hg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).||-0.34|-1.68|0.0033
72424982|NCT02247804|144361142|SUPERIORITY|MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.|Least-squares Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.34||0.0187|TWO_SIDED|95.0|-1.47|-0.13|||MMRM|||Change from Baseline Week 2, Hour 0: The null hypothesis was that bimatoprost SR 10 μg was to be declared superior to timolol 0.5% if the upper limit of the 95% CI was \< 0 mm Hg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).||-0.13|-1.47|0.0187
72424983|NCT02247804|144361142|SUPERIORITY|MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.|Least-squares Mean Difference|-0.85|STANDARD_ERROR_OF_MEAN|0.31||0.0057|TWO_SIDED|95.0|-1.45|-0.25|||MMRM|||Change from Baseline Week 2, Hour 2: The null hypothesis was that bimatoprost SR 15 μg was to be declared superior to timolol 0.5% if the upper limit of the 95% CI was \< 0 mm Hg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).||-0.25|-1.45|0.0057
72424984|NCT02247804|144361142|SUPERIORITY|MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.|Least-squares Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|0.3||0.0031|TWO_SIDED|95.0|-1.5|-0.31|||MMRM|||Change from Baseline Week 2, Hour 2: The null hypothesis was that bimatoprost SR 10 μg was to be declared superior to timolol 0.5% if the upper limit of the 95% CI was \< 0 mm Hg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).||-0.31|-1.50|0.0031
72334221|NCT01559259|144191646|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|3.99||||0.416|TWO_SIDED|95.0|-5.52|13.49||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||3 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||13.49|-5.52|0.416
72424985|NCT02247804|144361142|SUPERIORITY|MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.|Least-squares Mean Difference|-0.63|STANDARD_ERROR_OF_MEAN|0.32||0.0547|TWO_SIDED|95.0|-1.26|0.01|||MMRM|||Change from Baseline Week 6, Hour 0: The null hypothesis was that bimatoprost SR 15 μg was to be declared superior to timolol 0.5% if the upper limit of the 95% CI was \< 0 mm Hg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).||0.01|-1.26|0.0547
72424986|NCT02247804|144361142|SUPERIORITY|MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.|Least-squares Mean Difference|-0.82|STANDARD_ERROR_OF_MEAN|0.32||0.0107|TWO_SIDED|95.0|-1.46|-0.19|||MMRM|||Change from Baseline Week 6, Hour 0: The null hypothesis was that bimatoprost SR 10 μg was to be declared superior to timolol 0.5% if the upper limit of the 95% CI was \< 0 mm Hg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).||-0.19|-1.46|0.0107
72334222|NCT01559259|144191646|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|71.1|||<|0.001|TWO_SIDED|95.0|55.82|86.38||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||4 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||86.38|55.82|<0.001
72424987|NCT02247804|144361142|SUPERIORITY|MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.|Least-squares Mean Difference|-0.54|STANDARD_ERROR_OF_MEAN|0.32||0.086|TWO_SIDED|95.0|-1.16|0.08|||MMRM|||Change from Baseline Week 6, Hour 2: The null hypothesis was that bimatoprost SR 15 μg was to be declared superior to timolol 0.5% if the upper limit of the 95% CI was \< 0 mm Hg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).||0.08|-1.16|0.0860
72424988|NCT02247804|144361142|SUPERIORITY|MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.|Least-squares Mean Difference|-0.66|STANDARD_ERROR_OF_MEAN|0.31||0.0362||95.0|-1.27|-0.04|||MMRM|||Change from Baseline Week 6, Hour 2: The null hypothesis was that bimatoprost SR 10 μg was to be declared superior to timolol 0.5% if the upper limit of the 95% CI was \< 0 mm Hg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).||-0.04|-1.27|0.0362
72424989|NCT02917265|144361143|SUPERIORITY|||||||0.05|||||||Chi-squared|||||||0.05
72424990|NCT00007475|144361193|SUPERIORITY_OR_OTHER||Proportion with reduced proteinuria|0.6363|STANDARD_ERROR_OF_MEAN|0.0698|<|0.0001|TWO_SIDED|95.0|0.3079|0.8907||Exact binomial test of proportion of participants exhibiting reduction in proteinuria (see definition below), under null hypothesis that the overall proportion is zero.|Exact binomial test|Tested under null hypothesis that the overall proportion is zero.|Proportion event definition: exhibiting reduction in proteinuria post-cyclophosphamide (complete- \[urine protein {UP} \<0.3\] or or partial-remission \[between 0.3 \& 2.0, inclusive\], limited response \[UP between 2.0 \& 3.5\] yet no relapse \[UP 3.5+\]).|No groups compared, yet null hypothesis: pooled proportion = 0, tested using counts pooled across baseline FPF assay-availability groups (7 across 3 arms) excluding 4 non-completers (yielding 7/11 with event below). Given the modest group-specific sample sizes and tendency for zero outcomes to be observed in a group, we employ exact binomial 95% confidence intervals using the method of Clopper and Pearson (1934; calculated along with corresponding tests using Michael Fay's exactci package in R).||0.8907|0.3079|<0.0001
72424991|NCT00936221|144361208|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.93||||0.3873|TWO_SIDED|80.0|0.67|1.28||1-sided p-value|Regression, Cox|Cox model adjusting for treatment, WHO performance status, LDH, M status and tumour sub-type.||If the true hazard ratio (HR) is 0.57, 58 deaths provides at least 80% power to demonstrate a statistically significant difference for OS, assuming a 1-sided 10% significance level.||1.28|0.67|0.3873
72424992|NCT00879996|144361232|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.9134||||0.77|TWO_SIDED|95.0|0.4156|2.007|||Log Rank|||Null hypothesis: Methadone and buprenorphine treatment do not differ in treatment retention.||2.007|0.4156|0.77
72424993|NCT00879996|144361233|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2|||<|0.043||95.0|||||ANOVA|||Null hypothesis: Methadone treatment is as effective as buprenorphine treatment in reducing pain.||||<0.043
72424994|NCT00879996|144361234|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3|STANDARD_DEVIATION|0.0|<|0.665|TWO_SIDED|95.0|||||ANOVA|||null-hypothesis: methadone and buprenorphine treatment are equally effective in reducing self-reported functioning at 6 months.||||<0.665
72424995|NCT00879996|144361235|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.0|STANDARD_DEVIATION|0.0|<|0.039|TWO_SIDED|95.0|||||Fisher Exact|||Null hypothesis: methadone or buprenorphine treatment equally reduce illicit drug use.||||<0.039
72334223|NCT01559259|144191646|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|68.31|||<|0.001|TWO_SIDED|95.0|52.88|83.74||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||4 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||83.74|52.88|<0.001
72334224|NCT01559259|144191646|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|69.98|||<|0.001|TWO_SIDED|95.0|54.47|85.48||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||4 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||85.48|54.47|<0.001
72334225|NCT01559259|144191646|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|65.95|||<|0.001|TWO_SIDED|95.0|50.16|81.74||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||4 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||81.74|50.16|<0.001
72334226|NCT01559259|144191646|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|5.25||||0.265|TWO_SIDED|95.0|-3.92|14.41||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||4 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||14.41|-3.92|0.265
72334227|NCT01559259|144191646|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|1.85||||0.71|TWO_SIDED|95.0|-7.82|11.53||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||4 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||11.53|-7.82|0.710
72334228|NCT01559259|144191646|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|3.99||||0.416|TWO_SIDED|95.0|-5.52|13.49||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||4 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||13.49|-5.52|0.416
72334229|NCT01559259|144191646|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|71.1|||<|0.001|TWO_SIDED|95.0|55.82|86.38||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||5 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||86.38|55.82|<0.001
72424996|NCT02597933|144361239|OTHER||Mean Difference (Final Values)|40.95|STANDARD_ERROR_OF_MEAN|19.38||0.035|TWO_SIDED|95.0|2.88|79.01|||random coefficient regression||The model assumed that data were missing at random \& that patients who dropped out would have behaved similarly to those who remained in trial.|The primary analysis is a restricted maximum likelihood (REML) based approach using a random slope \& intercept model. The analysis included the fixed, categorical effects of treatment, ATA status \& gender, fixed continuous effects of time \& baseline FVC (mL), age and height as well as the treatment-by time \& baseline-by-time interactions. Random effects was included for patient response for both time \& intercept.Within-patient errors are modelled by an unstructured variance-covariance matrix||79.01|2.88|0.0350
72424997|NCT02597933|144361239|OTHER||Mean Difference (Final Values)|43.13||||0.0378|TWO_SIDED|95.0|2.44|83.83|||random coefficient regression|The model assumed that data were missing at random \& that patients who dropped out would have behaved similarly to those who remained in trial.||"This is a sensitivity analysis (SA) on primary endpoint including only on-trt measurements of FVC \[mL\]. The random coefficient model was used. The analysis included fixed, categorical effects of trt, ATA status \& gender, fixed continuous effects of time \& bl. FVC (mL), age, height, trt -by time \& bl.-by-time interactions. Random effects included for patient response for both time \& intercept.~Within-patient errors were modelled by an Unstructured variance-covariance matrix."||83.83|2.44|0.0378
72424998|NCT02597933|144361239|OTHER||Mean Difference (Final Values)|30.0||||0.1046|TWO_SIDED|95.0|-6.22|66.22|||random coefficient regression|||In multiple imputation SA 1, missing FVC values at wk 52 in pts who were alive at wk 52 were imputed assuming similar rate of FVC decline as in pts from corresponding trt group who prematurely disc. trial drug but had wk 52 FVC value. Missing FVC values at wk 52 in pts who died before wk 52 were imputed assuming similar rate of FVC decline as in pl. pts with wk 52 FVC value who prematurely disc. trial drug with most severe declines.The imputation model was similar to statistical model of PA.||66.22|-6.22|0.1046
72424999|NCT02597933|144361239|OTHER||Mean Difference (Final Values)|32.93||||0.074|TWO_SIDED|95.0|-3.19|69.06|||random coefficient regression|||In multiple imputation SA 2, missing FVC values at wk 52 in pts who were alive at wk 52 were imputed assuming similar rate of FVC decline as in pts from pl. group who prematurely disc. trial drug but had a wk 52 FVC value. Missing FVC values at wk 52 in pts who died before wk 52 were imputed assuming similar rate of FVC decline as in pl. pts with a wk 52 FVC value who prematurely disc. trial drug with most severe declines. The imputation model was similar to the statistical model of the PA||69.06|-3.19|0.0740
72425000|NCT02597933|144361239|OTHER||Mean Difference (Final Values)|33.86||||0.0644|TWO_SIDED|95.0|-2.03|69.75|||random coefficient regression|||In multiple imputation SA 3, missing FVC values at wk 52 in pts who were alive at wk 52 were imputed assuming a similar rate of FVC decline as in all pts in the pl. group who were included in the PA. Missing FVC values at wk 52 in pts who died before wk 52 were imputed assuming a similar rate of FVC decline as in all placebo patients included in the primary analysis with the most severe declines. The imputation model was similar to the statistical model of the PA.||69.75|-2.03|0.0644
72425001|NCT02597933|144361239|OTHER||Mean Difference (Final Values)|40.95||||0.0351|TWO_SIDED|95.0|2.88|79.01|||random coefficient regression|||This is sensitivity analysis using the model similar to the primary analysis but including a different set of covariates: the fixed, categorical effects of treatment, ATA status, the fixed continuous effects of time, baseline FVC (mL), and the treatment-by-time and baseline-by-time interactions.Random effects was included for patient response for both time and intercept.||79.01|2.88|0.0351
72425002|NCT02597933|144361239|OTHER||Mean Difference (Final Values)|40.98||||0.0349|TWO_SIDED|95.0|2.92|79.04|||random coefficient regression|||This is sensitivity analysis using the model similar to the primary analysis but including a different set of covariates: the fixed, categorical effects of treatment, ATA status (Positive / Negative), gender and mycophenolate mofetil /sodium background therapy use (Yes / No), fixed continuous effects of time, age , height and baseline FVC (mL), the treatment-by-time and baseline-by-time interactions. Random effects was included for patient response for both time and intercept||79.04|2.92|0.0349
72425003|NCT02597933|144361240|OTHER||Mean Difference (Final Values)|-0.21|STANDARD_ERROR_OF_MEAN|0.37||0.5785|TWO_SIDED|95.0|-0.94|0.53|||MMRM|||The mixed model repeated measures (MMRM) approach was used. The model assumed that data were missing at random \& that patients who dropped out would have behaved similarly to those who remained in trial.||0.53|-0.94|0.5785
72425004|NCT02597933|144361241|OTHER||Mean Difference (Final Values)|1.69|STANDARD_ERROR_OF_MEAN|1.24||0.1711|TWO_SIDED|95.0|-0.73|4.12|||MMRM|The MMRM model assumed that data were missing at random \& that patients who dropped out would have behaved similarly to those who remained in trial.||Based on mixed model repeated measures (MMRM) approach was used, with fixed categorical effects of ATA status, visit, treatment-by visit interaction and baseline-by-visit interaction. Visit was the repeated measure. Within-patient errors were modelled by unstructured variance-covariance structure.||4.12|-0.73|0.1711
72334230|NCT01559259|144191646|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|68.31|||<|0.001|TWO_SIDED|95.0|52.88|83.74||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||5 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||83.74|52.88|<0.001
72425005|NCT02597933|144361242|OTHER||Mean Difference (Final Values)|1.15|STANDARD_ERROR_OF_MEAN|0.54||0.0331|TWO_SIDED|1.15|0.09|2.21|||MMRM|The model assumed that data were missing at random \& that patients who dropped out would have behaved similarly to those who remained in trial.||"Based on a random coefficient regression with fixed categorical effects of treatment, ATA status, fixed continuous effects of time, baseline FVC \[% pred\], \& including treatment-by-time and baseline-by-time interactions. Random effect was included for patient specific intercept \& time.~Within-patient errors are modelled by an Unstructured variance-covariance matrix.~Inter-individual variability is modelled by a Variance-Components variance-covariance matrix."||2.21|0.09|0.0331
72425006|NCT02597933|144361243|OTHER||Mean Difference (Final Values)|46.41|STANDARD_ERROR_OF_MEAN|19.51||0.0177|TWO_SIDED|95.0|8.09|84.73|||MMRM|The model assumed that data were missing at random \& that patients who dropped out would have behaved similarly to those who remained in trial.||Based on mixed model repeated measures (MMRM) approach was used, with fixed categorical effects of ATA status, visit, treatment-by-visit interaction and baseline-by-visit interaction. Visit was the repeated measure. Within-patient errors were modelled by unstructured variance-covariance structure.||84.73|8.09|0.0177
72425007|NCT02597933|144361244|OTHER||Mean Difference (Final Values)|-6.28|STANDARD_ERROR_OF_MEAN|8.39||0.4547|TWO_SIDED|95.0|-22.77|10.21|||MMRM|The model assumed that data were missing at random \& that patients who dropped out would have behaved similarly to those who remained in trial.||Based on mixed model repeated measures (MMRM) approach was used, with fixed categorical effects of ATA status, visit, treatment-by-visit interaction and baseline-by-visit interaction. Visit was the repeated measure. Within-patient errors were modelled by unstructured variance-covariance structure.||10.21|-22.77|0.4547
72425008|NCT02597933|144361245|OTHER||Hazard Ratio (HR)|1.16||||0.7535|TWO_SIDED|95.0|0.47|2.84|||Regression, Cox|Based on Cox's regression model (Wald test), stratified by ATA status.||||2.84|0.47|0.7535
72425009|NCT02597933|144361246|OTHER||Odds Ratio (OR)|1.03||||0.9115|TWO_SIDED|95.0|0.57|1.88|||Cochran-Mantel-Haenszel|||The comparison between both treatment groups was performed using a Cochran-Mantel-Haenszel test. CRISS score at Week 52 was transformed into 100 binary responder endpoints using multiple imputation. These were analyzed using a Cochran-Mantel-Haenszel test, stratified by ATA status OR and the 95% confidence interval (CI) as obtained from all 100 imputations were combined using Rubin´s rule.|Missing values were imputed using worst case, i.e. considered having disease progression.|1.88|0.57|0.9115
72425010|NCT02597933|144361247|OTHER||Mean Difference (Final Values)|-0.44|STANDARD_ERROR_OF_MEAN|0.76||0.5668|TWO_SIDED|95.0|-1.94|1.06|||MMRM|||Based on mixed model repeated measures (MMRM) approach was used, with fixed categorical effects of ATA status, visit, treatment-by-visit interaction and baseline-by-visit interaction. Visit was the repeated measure. Within-patient errors were modelled by unstructured variance-covariance structure.||1.06|-1.94|0.5668
72425011|NCT02597933|144361248|OTHER||Mean Difference (Final Values)|-0.03|STANDARD_ERROR_OF_MEAN|0.06||0.5914|TWO_SIDED|95.0|-0.16|0.09|||MMRM|||Based on mixed model repeated measures (MMRM) approach was used, with fixed categorical effects of ATA status, visit, treatment-by-visit interaction and baseline-by-visit interaction. Visit was the repeated measure. Within-patient errors were modelled by unstructured variance-covariance structure.||0.09|-0.16|0.5914
72425012|NCT02597933|144361249|OTHER||Mean Difference (Final Values)|0.032|STANDARD_ERROR_OF_MEAN|0.034||0.3447|TWO_SIDED|95.0|-0.035|0.099|||MMRM|||Based on mixed model repeated measures (MMRM) approach was used, with fixed categorical effects of ATA status, visit, treatment-by-visit interaction and baseline-by-visit interaction. Visit was the repeated measure. Within-patient errors were modelled by unstructured variance-covariance structure.||0.099|-0.035|0.3447
72425013|NCT02597933|144361250|OTHER||Mean Difference (Final Values)|0.64|STANDARD_ERROR_OF_MEAN|0.58||0.2727|TWO_SIDED|95.0|-0.51|1.79|||MMRM|||Based on mixed model repeated measures (MMRM) approach was used, with fixed categorical effects of ATA status, visit, treatment-by-visit interaction and baseline-by-visit interaction. Visit was the repeated measure. Within-patient errors were modelled by unstructured variance-covariance structure.||1.79|-0.51|0.2727
72369460|NCT00662675|144249022|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|The p-value is from ANCOVA model with treatment as a factor and baseline percent COA-fat as a covariate.||The power calculation was based on the assumption that the true mean difference between the active and the placebo group was 31.2% with a common standard deviation of 22.6% using a 2-sided, 2-sample, t-test with a 5% significance level.||||<0.001
72425014|NCT01097915|144361261|SUPERIORITY_OR_OTHER||||||<|0.01|||||||Fisher Exact|||||||<0.01
72425015|NCT01097915|144361262|SUPERIORITY_OR_OTHER||||||<|0.004|||||||ANOVA|||||||<0.004
72425016|NCT01097915|144361263|SUPERIORITY_OR_OTHER||||||<|0.048|||||||ANCOVA|the three factors of the Stunkard and Messick Questionnaire were considered as covariates.||||||<0.048
72425017|NCT01097915|144361264|SUPERIORITY_OR_OTHER||||||<|1e-05|||||||ANOVA|||||||< 0.00001
72425018|NCT01097915|144361265|SUPERIORITY_OR_OTHER||||||<|1e-05|||||||ANOVA|||||||< 0.00001
72425019|NCT01097915|144361266|SUPERIORITY_OR_OTHER||||||<|1e-05|||||||Chi-squared|||||||< 0.00001
72425020|NCT04078035|144361267|SUPERIORITY||Slope|-0.00015|STANDARD_ERROR_OF_MEAN|0.00088||0.86|TWO_SIDED||||||Mixed Models Analysis|Subject, day (nested within subject), and time as random effects and condition (stress/control) as fixed effects.||Results below present the condition (stress/control) by time interactions.||||0.86
72425021|NCT04078035|144361268|SUPERIORITY||Slope|0.00022|STANDARD_ERROR_OF_MEAN|0.00067||0.74|TWO_SIDED||||||Mixed Models Analysis|Subject, day (nested within subject), and time as random effects and condition (stress/control) as fixed effects.||Results present the condition (stress/control) by time interactions.||||0.74
72425022|NCT04078035|144361269|SUPERIORITY||Slope|-0.0012|STANDARD_ERROR_OF_MEAN|0.0019||0.52|TWO_SIDED||||||Mixed Models Analysis|Subject, day (nested within subject), and time as random effects and condition (stress/control) as fixed effects.||Results below present the condition (stress/control) by time interactions.||||0.52
72425023|NCT04078035|144361270|SUPERIORITY|Results present the condition (stress/control) by time\^2 interactions.|Slope|-0.34|STANDARD_ERROR_OF_MEAN|0.04|<|0.001|TWO_SIDED||||||Mixed Models Analysis|Likelihood ratio test showed better fit if quadratic for time included χ2 (2) = 77.2, p \< .001.||||||<.001
72369461|NCT00662675|144249023|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The p-value is from ANCOVA model with treatment as a factor and baseline percent COA-protein(nitrogen) as a covariate.|ANCOVA|||||||<0.001
72369462|NCT00689260|144249031|SUPERIORITY_OR_OTHER|||||||0.908||95.0|||||Wilcoxon (Mann-Whitney)|||P-Value based on two-sided Wilcoxon rank-sum test for difference in medians between log aware and log unaware||||0.908
72369463|NCT02948634|144249078|SUPERIORITY|||||||0.43|||||||ANOVA|||||||0.43
72425024|NCT04078035|144361271|SUPERIORITY||Slope|0.0021|STANDARD_ERROR_OF_MEAN|0.00027|<|0.001|TWO_SIDED||||||Mixed Models Analysis|Likelihood ratio test showed better fit if quadratic for time included χ2 (2) = 66.4, p \< .001.||Results-interaction between time2 and condition||||<.001
72425025|NCT04078035|144361272|SUPERIORITY||Slope|0.0013|STANDARD_ERROR_OF_MEAN|0.0002|<|0.001|TWO_SIDED||||||Mixed Models Analysis|Likelihood ratio test showed better fit if quadratic for time included χ2 (2) = 77.2, p \< .001.||Results-interaction between time\^2 and condition||||<.001
72334231|NCT01559259|144191646|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|69.98|||<|0.001|TWO_SIDED|95.0|54.47|85.48||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||5 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||85.48|54.47|<0.001
72334232|NCT01559259|144191646|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|65.95|||<|0.001|TWO_SIDED|95.0|50.16|81.74||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||5 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||81.74|50.16|<0.001
72334233|NCT01559259|144191646|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|5.25||||0.265|TWO_SIDED|95.0|-3.92|14.41||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||5 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||14.41|-3.92|0.265
72334234|NCT01559259|144191646|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|1.85||||0.71|TWO_SIDED|95.0|-7.82|11.53||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||5 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||11.53|-7.82|0.710
72334235|NCT01559259|144191646|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|3.99||||0.416|TWO_SIDED|95.0|-5.52|13.49||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||5 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||13.49|-5.52|0.416
72334236|NCT01559259|144191646|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|71.1|||<|0.001|TWO_SIDED|95.0|55.82|86.38||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||6 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||86.38|55.82|<0.001
72334237|NCT01559259|144191646|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|68.31|||<|0.001|TWO_SIDED|95.0|52.88|83.74||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||6 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||83.74|52.88|<0.001
72334238|NCT01559259|144191646|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|69.98|||<|0.001|TWO_SIDED|95.0|54.47|85.48||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||6 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||85.48|54.47|<0.001
72334239|NCT01559259|144191646|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|65.95|||<|0.001|TWO_SIDED|95.0|50.16|81.74||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||6 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||81.74|50.16|<0.001
72334240|NCT01559259|144191646|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|5.25||||0.265|TWO_SIDED|95.0|-3.92|14.41||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||6 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||14.41|-3.92|0.265
72369464|NCT02948634|144249079|SUPERIORITY|||||||0.32|||||||ANOVA|||||||0.32
72369465|NCT02948634|144249080|SUPERIORITY||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
72369466|NCT04661579|144249091|OTHER||Vaccine Efficacy|35.9||||0.009|TWO_SIDED|95.0|10.3|54.2|||Wald test||Vaccine efficacy (VE) is defined as the percent reduction in the hazard, i.e. one minus the hazard ratio (HR, RTS,S/AS01E Vaccine vs. Rabies vaccine).|Vaccine efficacy against the first PCR-positive P. falciparum infection among adults who were P. falciparum positive at baseline was assessed using Cox proportional hazards regression model with a covariate for group assignment to compare Groups 1 and 4. HIV status, Age (tertiles), and sleep under a bednet were included as covariates.||54.2|10.3|0.009
72425026|NCT04078035|144361273|SUPERIORITY||Slope|0.0037|STANDARD_ERROR_OF_MEAN|0.0013||0.005|TWO_SIDED||||||Mixed Models Analysis|||Results below present the condition (stress/control) by time interactions.||||0.005
72425027|NCT04078035|144361274|SUPERIORITY||Slope|-0.0071|STANDARD_ERROR_OF_MEAN|0.074||0.92|TWO_SIDED||||||Mixed Models Analysis|Subject, day (nested within subject), and time as random effects and condition (stress/control) as fixed effects.||Results below present the condition (stress/control) by time interactions.||||0.92
72425028|NCT04078035|144361275|SUPERIORITY||Slope|-0.85|STANDARD_ERROR_OF_MEAN|0.41||0.04|TWO_SIDED||||||Mixed Models Analysis|Subject, day (nested within subject), and time as random effects and condition (stress/control) as fixed effects.||Results below present the condition (stress/control) by time interactions.||||0.04
72425029|NCT04078035|144361276|SUPERIORITY||Slope|0.01|STANDARD_ERROR_OF_MEAN|0.0033||0.002|TWO_SIDED|||||Subject, day (nested within subject), and time as random effects and condition (stress/control) as fixed effects.|Mixed Models Analysis|Likelihood ratio test showed better fit if quadratic for time included χ2 (2) = 15.64, p \< .001.||Results-interaction between time\^2 and condition||||0.002
72425030|NCT04078035|144361277|SUPERIORITY||Slope|0.014|STANDARD_ERROR_OF_MEAN|0.0053||0.008|TWO_SIDED||||||Mixed Models Analysis|Subject, day (nested within subject), and time as random effects and condition (stress/control) as fixed effects.||Results \_condition (stress/control) by time interactions.||||0.008
72425031|NCT04078035|144361278|SUPERIORITY||Slope|-0.0003|STANDARD_ERROR_OF_MEAN|0.0014||0.83|TWO_SIDED||||||Mixed Models Analysis|Subject, day (nested within subject), and time as random effects and condition (stress/control) as fixed effects.||Results below present the condition (stress/control) by time interactions.||||0.83
72425032|NCT04078035|144361279|SUPERIORITY||Slope|-0.0074|STANDARD_ERROR_OF_MEAN|0.0033||0.03|TWO_SIDED||||||Mixed Models Analysis|Subject, day (nested within subject), and time as random effects and condition (stress/control) as fixed effects.||Results below present the condition (stress/control) by time interactions.||||0.03
72425033|NCT04078035|144361280|SUPERIORITY||Slope|0.00075|STANDARD_ERROR_OF_MEAN|0.00012||0.51|TWO_SIDED||||||Mixed Models Analysis|Subject, day (nested within subject), and time as random effects and condition (stress/control) as fixed effects.||Results below present the condition (stress/control) by time interactions.||||0.51
72425034|NCT04078035|144361281|SUPERIORITY||Slope|-0.0053|STANDARD_ERROR_OF_MEAN|0.0026||0.04|TWO_SIDED||||||Mixed Models Analysis|Subject, day (nested within subject), and time as random effects and condition (stress/control) as fixed effects.||Results below present the condition (stress/control) by time interactions.||||0.04
72425035|NCT04078035|144361282|SUPERIORITY||Slope|0.0018|STANDARD_ERROR_OF_MEAN|0.0027||0.49|TWO_SIDED||||||Mixed Models Analysis|Subject, day (nested within subject), and time as random effects and condition (stress/control) as fixed effects.||Results below present the condition (stress/control) by time interactions.||||0.49
72334241|NCT01559259|144191646|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|1.85||||0.71|TWO_SIDED|95.0|-7.82|11.53||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||6 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||11.53|-7.82|0.710
72334242|NCT01559259|144191646|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|3.99||||0.416|TWO_SIDED|95.0|-5.52|13.49||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||6 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||13.49|-5.52|0.416
72334243|NCT01559259|144191646|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|71.1|||<|0.001|TWO_SIDED|95.0|55.82|86.38||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||7 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||86.38|55.82|<0.001
72334244|NCT01559259|144191646|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|68.31|||<|0.001|TWO_SIDED|95.0|52.88|83.74||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||7 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||83.74|52.88|<0.001
72334245|NCT01559259|144191646|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|69.98|||<|0.001|TWO_SIDED|95.0|54.47|85.48||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||7 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||85.48|54.47|<0.001
72334246|NCT01559259|144191646|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|65.95|||<|0.001|TWO_SIDED|95.0|50.16|81.74||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||7 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||81.74|50.16|<0.001
72334247|NCT01559259|144191646|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|5.25||||0.265|TWO_SIDED|95.0|-3.92|14.41||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||7 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||14.41|-3.92|0.265
72334248|NCT01559259|144191646|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|1.85||||0.71|TWO_SIDED|95.0|-7.82|11.53||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||7 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||11.53|-7.82|0.710
72334249|NCT01559259|144191646|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|3.99||||0.416|TWO_SIDED|95.0|-5.52|13.49||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||7 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||13.49|-5.52|0.416
72334250|NCT01559259|144191646|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|71.1|||<|0.001|TWO_SIDED|95.0|55.82|86.38||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||8 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||86.38|55.82|<0.001
72334251|NCT01559259|144191646|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|68.31|||<|0.001|TWO_SIDED|95.0|52.88|83.74||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||8 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||83.74|52.88|<0.001
72334252|NCT01559259|144191646|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|69.98|||<|0.001|TWO_SIDED|95.0|54.47|85.48||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||8 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||85.48|54.47|<0.001
72334253|NCT01559259|144191646|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|65.95|||<|0.001|TWO_SIDED|95.0|50.16|81.74||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||8 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||81.74|50.16|<0.001
72334254|NCT01559259|144191646|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|5.25||||0.265|TWO_SIDED|95.0|-3.92|14.41||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||8 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||14.41|-3.92|0.265
72425036|NCT04078035|144361283|SUPERIORITY||Slope|0.013|STANDARD_ERROR_OF_MEAN|0.0044||0.002|TWO_SIDED||||||Mixed Models Analysis|Subject, day (nested within subject), and time as random effects and condition (stress/control) as fixed effects.||Results below present the condition (stress/control) by time interactions.||||0.002
72425037|NCT00612534|144361284|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.26|STANDARD_ERROR_OF_MEAN|7.83||0.194||95.0|-5.32|25.83|||ANCOVA|||||25.83|-5.32|0.194
72425038|NCT00612534|144361284|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.67|STANDARD_ERROR_OF_MEAN|7.77||0.268|TWO_SIDED|95.0|-6.78|24.11|||ANCOVA|||||24.11|-6.78|0.268
72425039|NCT00612534|144361284|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|20.05|STANDARD_ERROR_OF_MEAN|8.3||0.018|TWO_SIDED|95.0|3.54|36.56|||ANCOVA|||||36.56|3.54|0.018
72425040|NCT00510458|144361293|OTHER|It is expected that the mean linear wear rate is not more than 0.08 mm per year or 0.05 mm per year superior to the reference control, which was 0.13 mm per year. The reference control was determined from the control group within the Post-approval Study of the ABC and Trident® Systems (NCT00960206).|mean linear wear rate at 5 yrs|0.008|||||TWO_SIDED|90.0|-0.0107|0.0267||||||||.0267|-0.0107|
72425041|NCT00510458|144361294|OTHER|To test if the change from pre-operative HHS compared to the post-operative HHS at all intervals is statistically significant.|||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
72425042|NCT00510458|144361295|OTHER|To test if the change from pre-operative HHS pain score compared to the post-operative HHS pain score at all intervals is statistically significant.|||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
72425043|NCT00510458|144361296|OTHER|To test if the change from pre-operative HHS ROM compared to the post-operative HHS ROM at all intervals is statistically significant.|||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
72425044|NCT00510458|144361297|OTHER|To test if the change from pre-operative SF-12 Physical component score compared to the post-operative SF-12 Physical component score at all intervals is statistically significant.|||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
72425045|NCT00510458|144361297|OTHER|To test if the change from pre-operative SF-12 Mental component score compared to the post-operative SF-12 Mental component score at 1 year is statistically significant.||||||0.0394|||||||t-test, 2 sided|||||||0.0394
72425046|NCT00510458|144361297|OTHER|To test if the change from pre-operative SF-12 Mental component score compared to the post-operative SF-12 Mental component score at 3 years is statistically significant.||||||0.4974|||||||t-test, 2 sided|||||||0.4974
72425047|NCT00510458|144361297|OTHER|To test if the change from pre-operative SF-12 Mental component score compared to the post-operative SF-12 Mental component score at 5 years is statistically significant.||||||0.677|||||||t-test, 2 sided|||||||0.6770
72425048|NCT00510458|144361298|OTHER|To test if the change from pre-operative LEAS compared to the post-operative LEAS at 1 year and 3 years is statistically significant.|||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
72425049|NCT00510458|144361298|OTHER|To test if the change from pre-operative LEAS compared to the post-operative LEAS at 5 years is statistically significant.||||||0.0006|||||||t-test, 2 sided|||||||0.0006
72425050|NCT01693692|144361309|SUPERIORITY||Mean Difference (Final Values)|-0.24|STANDARD_ERROR_OF_MEAN|0.25||0.1683|ONE_SIDED|95.0||0.2|||ANCOVA|||||0.2||0.1683
72425051|NCT01693692|144361309|SUPERIORITY||Mean Difference (Final Values)|-0.47|STANDARD_ERROR_OF_MEAN|0.25||0.0277|ONE_SIDED|95.0||-0.1|||ANCOVA|||||-0.1||0.0277
72425052|NCT01693692|144361310|SUPERIORITY||Mean Difference (Final Values)|-1.57|STANDARD_ERROR_OF_MEAN|2.48||0.2637|ONE_SIDED|95.0||2.5|||ANCOVA|||||2.5||0.2637
72425053|NCT01693692|144361310|SUPERIORITY||Mean Difference (Final Values)|-5.8|STANDARD_ERROR_OF_MEAN|2.47||0.0097|ONE_SIDED|95.0||-1.7|||ANCOVA|||||-1.7||0.0097
72425054|NCT01693692|144361311|SUPERIORITY||Mean Difference (Final Values)|-0.24|STANDARD_ERROR_OF_MEAN|0.16||0.0639|ONE_SIDED|95.0||0.0|||ANCOVA|||||0.0||0.0639
72425055|NCT01693692|144361311|SUPERIORITY||Mean Difference (Final Values)|-0.39|STANDARD_ERROR_OF_MEAN|0.16||0.007|ONE_SIDED|95.0||-0.1|||ANCOVA|||||-0.1||0.0070
72425056|NCT01486758|144361344|SUPERIORITY_OR_OTHER|||||||0.6|||||||ANCOVA|||||||0.6
72425057|NCT01486758|144361348|SUPERIORITY_OR_OTHER|||||||0.048|||||||Log Rank|||||||0.048
72425058|NCT02608489|144361374|SUPERIORITY_OR_OTHER|||||||0.221|||||||Mixed Models Analysis|||To obtain an overall comparison between treatment responses throughout the study period considering the 2 levels of correlation in subjects and follow-up, a linear mixed model with asymmetric random effects was used.||||0.221
72425059|NCT02608489|144361374|SUPERIORITY_OR_OTHER|||||||0.015|||||||Mixed Models Analysis|||Linear mixed model was used to compare measurement data between the 2 groups by considering the correlation between both eyes of each patient at postoperative week 12 follow-up.||||0.015
72425060|NCT02608489|144361375|SUPERIORITY_OR_OTHER|||||||0.256|||||||Mixed Models Analysis|||To obtain an overall comparison between treatment responses throughout the study period considering the 2 levels of correlation in subjects and follow-up, a linear mixed model with asymmetric random effects was used.||||0.256
72425061|NCT02608489|144361375|SUPERIORITY_OR_OTHER|||||||0.025|||||||Mixed Models Analysis|||Linear mixed model was used to compare measurement data between the 2 groups by considering the correlation between both eyes of each patient at Postoperative week 12 follow-up.||||0.025
72425062|NCT02608489|144361376|SUPERIORITY_OR_OTHER|||||||0.08|||||||Mixed Models Analysis|||To obtain an overall comparison between treatment responses throughout the study period considering the 2 levels of correlation in subjects and follow-up, a linear mixed model with asymmetric random effects was used.||||0.080
72425063|NCT02608489|144361376|SUPERIORITY_OR_OTHER|||||||0.021|||||||Mixed Models Analysis|||Linear mixed model was used to compare measurement data between the 2 groups by considering the correlation between both eyes of each patient at postoperative week 12 follow-up.||||0.021
72425064|NCT02608489|144361377|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Mixed Models Analysis|||To obtain an overall comparison between treatment responses throughout the study period considering the 2 levels of correlation in subjects and follow-up, a linear mixed model with asymmetric random effects was used.||||<0.001
72425065|NCT02608489|144361377|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Mixed Models Analysis|||Linear mixed model was used to compare measurement data between the 2 groups by considering the correlation between both eyes of each patient at postoperative week 4||||<0.001
72334255|NCT01559259|144191646|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|1.85||||0.71|TWO_SIDED|95.0|-7.82|11.53||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||8 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||11.53|-7.82|0.710
72334256|NCT01559259|144191646|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|3.99||||0.416|TWO_SIDED|95.0|-5.52|13.49||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||8 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||13.49|-5.52|0.416
72334257|NCT01559259|144191646|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|71.1|||<|0.001|TWO_SIDED|95.0|55.82|86.38||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||9 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||86.38|55.82|<0.001
72334258|NCT01559259|144191646|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|68.31|||<|0.001|TWO_SIDED|95.0|52.88|83.74||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||9 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||83.74|52.88|<0.001
72334259|NCT01559259|144191646|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|69.98|||<|0.001|TWO_SIDED|95.0|54.47|85.48||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||9 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||85.48|54.47|<0.001
72334260|NCT01559259|144191646|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|65.95|||<|0.001|TWO_SIDED|95.0|50.16|81.74||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||9 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||81.74|50.16|<0.001
72334261|NCT01559259|144191646|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|5.25||||0.265|TWO_SIDED|95.0|-3.92|14.41||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||9 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||14.41|-3.92|0.265
72334262|NCT01559259|144191646|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|1.85||||0.71|TWO_SIDED|95.0|-7.82|11.53||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||9 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||11.53|-7.82|0.710
72334263|NCT01559259|144191646|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|3.99||||0.416|TWO_SIDED|95.0|-5.52|13.49||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||9 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||13.49|-5.52|0.416
72334264|NCT01559259|144191646|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|71.1|||<|0.001|TWO_SIDED|95.0|55.82|86.38||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||10 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||86.38|55.82|<0.001
72334265|NCT01559259|144191646|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|68.31|||<|0.001|TWO_SIDED|95.0|52.88|83.74||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||10 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||83.74|52.88|<0.001
72425066|NCT02608489|144361377|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Mixed Models Analysis|||Linear mixed model was used to compare measurement data between the 2 groups by considering the correlation between both eyes of each patient at postoperative week 12||||<0.001
72425067|NCT02608489|144361378|SUPERIORITY_OR_OTHER|||||||0.045|||||||Mixed Models Analysis|||To obtain an overall comparison between treatment responses throughout the study period considering the 2 levels of correlation in subjects and follow-up, a linear mixed model with asymmetric random effects was used.||||0.045
72425068|NCT02608489|144361379|SUPERIORITY_OR_OTHER|||||||0.001|||||||Mixed Models Analysis|||To obtain an overall comparison between treatment responses throughout the study period considering the 2 levels of correlation in subjects and follow-up, a linear mixed model with asymmetric random effects was used.||||0.001
72425069|NCT02608489|144361379|SUPERIORITY_OR_OTHER|||||||0.002|||||||Mixed Models Analysis|||Linear mixed model was used to compare measurement data between the 2 groups by considering the correlation between both eyes of each patient at postoperative week 4||||0.002
72425070|NCT02608489|144361379|SUPERIORITY_OR_OTHER|||||||0.034|||||||Mixed Models Analysis|||Linear mixed model was used to compare measurement data between the 2 groups by considering the correlation between both eyes of each patient at postoperative week 12||||0.034
72425071|NCT02608489|144361380|SUPERIORITY_OR_OTHER|||||||0.151|||||||Mixed Models Analysis|||To obtain an overall comparison between treatment responses throughout the study period considering the 2 levels of correlation in subjects and follow-up, a linear mixed model with asymmetric random effects was used.||||0.151
72425072|NCT01411501|144361382|SUPERIORITY_OR_OTHER|||||||0.352|TWO_SIDED||||||ANCOVA|||||||0.352
72425073|NCT01411501|144361383|SUPERIORITY_OR_OTHER|||||||0.968|TWO_SIDED||||||ANCOVA|||||||0.968
72425074|NCT01411501|144361384|SUPERIORITY_OR_OTHER|||||||0.841|TWO_SIDED||||||Kruskal-Wallis|||||||0.841
72425075|NCT01411501|144361385|SUPERIORITY_OR_OTHER|||||||0.005|TWO_SIDED||||||ANCOVA|||||||0.005
72425076|NCT01411501|144361386|SUPERIORITY_OR_OTHER|||||||0.198|TWO_SIDED||||||ANCOVA|||||||0.198
72425077|NCT01411501|144361387|SUPERIORITY_OR_OTHER|||||||0.035|TWO_SIDED||||||Kruskal-Wallis|||||||0.035
72425078|NCT01703702|144361394|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.7||||0.002|TWO_SIDED|95.0|1.22|2.38|||Chi-squared|||||2.38|1.22|0.002
72334266|NCT01559259|144191646|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|69.98|||<|0.001|TWO_SIDED|95.0|54.47|85.48||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||10 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||85.48|54.47|<0.001
72334267|NCT01559259|144191646|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|65.95|||<|0.001|TWO_SIDED|95.0|50.16|81.74||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||10 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||81.74|50.16|<0.001
72334268|NCT01559259|144191646|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|5.25||||0.265|TWO_SIDED|95.0|-3.92|14.41||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||10 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||14.41|-3.92|0.265
72425079|NCT01703702|144361395|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.35||||0.568|TWO_SIDED|95.0|-1.54|0.84|||ANCOVA|Adjusted for: Baseline ADAS-Cog score, study arm, Alzheimer's treatment, country, and interaction between study arm and Alzheimer's treatment.||||0.84|-1.54|0.568
72425080|NCT01703702|144361396|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|43.9|||<|0.001|TWO_SIDED|95.0|20.0|96.12|||Chi-squared|||||96.12|20|<0.001
72334269|NCT01559259|144191646|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|1.85||||0.71|TWO_SIDED|95.0|-7.82|11.53||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||10 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||11.53|-7.82|0.710
72334270|NCT01559259|144191646|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|3.99||||0.416|TWO_SIDED|95.0|-5.52|13.49||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||10 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||13.49|-5.52|0.416
72334271|NCT01559259|144191646|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|71.1|||<|0.001|TWO_SIDED|95.0|55.82|86.38||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||11 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||86.38|55.82|<0.001
72334272|NCT01559259|144191646|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|68.31|||<|0.001|TWO_SIDED|95.0|52.88|83.74||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||11 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||83.74|52.88|<0.001
72334273|NCT01559259|144191646|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|69.98|||<|0.001|TWO_SIDED|95.0|54.47|85.48||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||11 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||85.48|54.47|<0.001
72334274|NCT01559259|144191646|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|65.95|||<|0.001|TWO_SIDED|95.0|50.16|81.74||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||11 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||81.74|50.16|<0.001
72334275|NCT01559259|144191646|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|5.25||||0.265|TWO_SIDED|95.0|-3.92|14.41||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||11 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||14.41|-3.92|0.265
72425081|NCT01703702|144361397|SUPERIORITY_OR_OTHER||LS Mean Difference|20.69|||<|0.001|TWO_SIDED|95.0|18.95|22.43|||ANCOVA|Adjusted for: Cognitive status (mild impairment/dementia), physician/practice type, country and florbetapir F18 PET scan result (Aß+/Aß-)||Comparison of change in diagnostic confidence at follow-up (3 months)||22.43|18.95|<0.001
72334276|NCT01559259|144191646|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|1.85||||0.71|TWO_SIDED|95.0|-7.82|11.53||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||11 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||11.53|-7.82|0.710
72334277|NCT01559259|144191646|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|3.99||||0.416|TWO_SIDED|95.0|-5.52|13.49||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||11 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||13.49|-5.52|0.416
72425082|NCT01703702|144361398|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.28||||0.144|TWO_SIDED|95.0|0.92|1.78|||Chi-squared|||||1.78|0.92|0.144
72425083|NCT01703702|144361399|SUPERIORITY_OR_OTHER||LS Mean Difference|0.16||||0.925|TWO_SIDED|95.0|-3.2|3.53|||ANCOVA|Adjusted for: Baseline scale, Cognitive status (mild impairment/dementia), country and florbetapir F18 PET scan result (Aß+/Aß-).||||3.53|-3.20|0.925
72425084|NCT01703702|144361400|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.04||||0.857|TWO_SIDED|95.0|0.7|1.54|||Chi-squared|||Major Diagnostic Tests||1.54|0.70|0.857
72425085|NCT01703702|144361400|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.96|||<|0.001|TWO_SIDED|95.0|1.36|2.81|||Chi-squared|||Alzheimer's/Cognitive Medication||2.81|1.36|<0.001
72425086|NCT01703702|144361400|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.6||||0.063|TWO_SIDED|95.0|0.97|2.64|||Chi-squared|||Neuropsychological Tests||2.64|0.97|0.063
72425087|NCT01703702|144361400|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.08||||0.741|TWO_SIDED|95.0|0.69|1.7|||Chi-squared|||Physician Follow-up for Re-evaluation||1.70|0.69|0.741
72425088|NCT01703702|144361400|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.45||||0.046|TWO_SIDED|95.0|1.01|2.08|||Chi-squared|||Specialist Referral||2.08|1.01|0.046
72425089|NCT03980184|144361405|SUPERIORITY|||||||0.08|||||||Fisher Exact|||||||0.08
72425090|NCT03980184|144361406|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||<.001
72425091|NCT03980184|144361407|SUPERIORITY|||||||0.703|||||||Fisher Exact|||||||0.703
72425092|NCT03980184|144361409|SUPERIORITY|||||||0.002|||||||Fisher Exact|||||||0.002
72425093|NCT03980184|144361410|SUPERIORITY|||||||0.647|||||||Fisher Exact|||||||0.647
72425094|NCT03980184|144361411|SUPERIORITY|||||||0.887|||||||Fisher Exact|||||||0.887
72425095|NCT01200030|144361429|OTHER|The effect size of the intervention was adopted from a mate-analysis . The showed an average effect size of 0.59 in improving the motor control of limbs in people with stroke. A sample size for each group was set at 11 . Presuming that there would be a drop-out rate of 10% during the course of study, an extra 1 subject was recruited in each group. the sample size was 36. The statistical significance was set at 5% (alpha \< 0.05) with power equal to 80%|||||<|0.001||||||Post-hoc pairwise comparisons have been conducted. Please refer to subsequent data analyses.|Kruskal-Wallis|||Null hypothesis: No significant differences existed between the percentage of change in Trunk Impairment Scale (TIS) score among the three groups.||||<0.001
72425096|NCT01200030|144361429|OTHER|||||||1||||||The p-value was adjusted for multiple comparisons. A p-value smaller than 0.05 indicated statistical significance.|Wilcoxon (Mann-Whitney)|||Post-Hoc pairwise comparison comparing the effects of electrical stimulation with exercises group and placebo stimulation with exercises group. Null hypothesis: There was no significant difference existed on the changes of the Trunk Impairment Scale score between the two groups.||||1.00
72425097|NCT01200030|144361429|OTHER|||||||0.002||||||The p-value was adjusted for multiple comparisons. A p-value smaller than 0.05 indicated statistical significance.|Wilcoxon (Mann-Whitney)|||"Post-Hoc pairwise comparison comparing the effects of electrical stimulation with exercises group and control group.~Null hypothesis: There was no significant difference existed on the changes of the Trunk Impairment Scale score between the two groups."||||0.002
72425098|NCT01200030|144361429|OTHER|||||||0.003|||||||Wilcoxon (Mann-Whitney)|||"Post-Hoc pairwise comparison comparing the effects of placebo stimulation with exercises group and control group.~Null hypothesis: There was no significant difference existed on the changes of the Trunk Impairment Scale score between the two groups."||||0.003
72425099|NCT01200030|144361430|OTHER|||||||0.055|||||||Kruskal-Wallis|||Null hypothesis: No significant differences existed between the percentage of change in reaching distance between the three groups.||||0.055
72425100|NCT00136812|144361431|OTHER|We used all available observations in a GEE analysis and did not impute missing data or drop observations.|Odds Ratio (OR)|3.15||||0.018|TWO_SIDED|95.0|1.22|8.14||P-value of \<0.05 is considered statistically significant.|generalized estimating equation model|||To test the primary hypothesis, we ran a generalized estimating equation model with logit link function (PROC GENMOD in SAS version 9.2), to examine abstinence versus smoking status at the 3- through 18-month follow-ups by condition.||8.14|1.22|0.018
72425101|NCT04542226|144361436|OTHER||||||<|1e-07||||||the a priori threshold for statistical significance p\<0.05|Wilcoxon (Mann-Whitney)|Wilcoxon signed-rank test for repeated measures was used to compare with baseline.||||||<0.0000001
72425102|NCT02091739|144361445|SUPERIORITY||LS mean difference|-0.09|STANDARD_ERROR_OF_MEAN|0.031|=|0.004|TWO_SIDED|95.0|-0.15|0.03|||MMRM|||"A fixed sequence test procedure was used for the confirmatory analysis of the co-primary endpoints by comparing the least square (LS) means estimates of an mixed model repeated measurement (MMRM) model (2-sided, significance level alpha=0.05) between treatment groups in the following order:~1. IncobotulinumtoxinA 100 units versus (v) Placebo~2. IncobotulinumtoxinA 75 units v Placebo"||0.03|-0.15|= 0.004
72425103|NCT02091739|144361445|SUPERIORITY||LS mean difference|-0.02|STANDARD_ERROR_OF_MEAN|0.03|=|0.542|TWO_SIDED|95.0|-0.08|0.04|||MMRM|||"A fixed sequence test procedure was used for the confirmatory analysis of the co-primary endpoints by comparing the least square means estimates of an MMRM model (2-sided, significance level alpha=0.05) between treatment groups in the following order:~1. IncobotulinumtoxinA 100 units v Placebo~2. IncobotulinumtoxinA 75 units v Placebo"||0.04|-0.08|= 0.542
72425104|NCT02091739|144361446|SUPERIORITY||LS mean difference|0.58|STANDARD_ERROR_OF_MEAN|0.183|=|0.002|TWO_SIDED|95.0|0.22|0.94|||MMRM|||"A fixed sequence test procedure was used for the confirmatory analysis of the co-primary endpoints by comparing the least square means estimates of an MMRM model (2-sided, significance level alpha=0.05) between treatment groups in the following order:~1. IncobotulinumtoxinA 100 units v Placebo~2. IncobotulinumtoxinA 75 units v Placebo"||0.94|0.22|= 0.002
72425105|NCT02091739|144361446|SUPERIORITY||LS mean difference|0.35|STANDARD_ERROR_OF_MEAN|0.181|=|0.055|TWO_SIDED|95.0|-0.01|0.71|||MMRM|||"A fixed sequence test procedure was used for the confirmatory analysis of the co-primary endpoints by comparing the least square means estimates of an MMRM model (2-sided, significance level alpha=0.05) between treatment groups in the following order:~1. IncobotulinumtoxinA 100 units v Placebo~2. IncobotulinumtoxinA 75 units v Placebo"||0.71|-0.01|= 0.055
72425106|NCT00114634|144361499|SUPERIORITY_OR_OTHER|||||||1|||||||t-test, 2 sided|||||||1.0
72425107|NCT01003184|144361505|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.6|||<|0.0001|TWO_SIDED|95.0|3.17|13.73|||Regression, Logistic|Logistic regression model includes treatment group, use of SU (yes/no), baseline HbA1c and baseline weight as main factors.||"Primary objective: to test hypothesis that the percentage of patients with HbA1c ≤7.0% with weight loss (≥1.0 kg) after exenatide QW is superior to insulin detemir.~Sample size estimation: based on the test for difference in percentage between Exenatide QW and insulin detemir. Assuming: common drop-out rate 20%, response rate at endpoint 50% in the exenatide QW group and 25% in the insulin detemir group; 5% significance. 214 patients will provide 90% power to detect a difference."||13.73|3.17|<.0001
72425108|NCT01003184|144361506|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|7.06|||<|0.0001|TWO_SIDED|95.0|3.64|13.7|||Regression, Logistic|Logistic regression model includes the independent variables treatment group, use of SU (yes/no), baseline HbA1c and baseline weight.||||13.70|3.64|<.0001
72425109|NCT01003184|144361507|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.41|STANDARD_ERROR_OF_MEAN|0.104||0.0001|TWO_SIDED|95.0|-0.62|-0.2|||Mixed Models Analysis|||Mixed model repeated measures (MMRM) includes baseline value as covariate, study treatment, use of SU (yes/no), week of visit and treatment-by-week interaction as fixed effects and patient and error as random effects.||-0.20|-0.62|0.0001
72425110|NCT01003184|144361508|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-3.67|STANDARD_ERROR_OF_MEAN|0.488|<|0.0001|TWO_SIDED|95.0|-4.63|-2.71|||Mixed Models Analysis|||Mixed model repeated measures MMRM) includes baseline value as covariate, study treatment, use of SU (yes/no), baseline HbA1c stratum, week of visit and treatment-by-week interaction as fixed effects and patient and error as random effects.||-2.71|-4.63|<.0001
72425111|NCT01003184|144361509|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.79||||0.0497|TWO_SIDED|95.0|1.0|3.18|||Regression, Logistic|||Logistic regression model includes independent variables treatment group, use of SU (yes/no), and baseline HbA1c.||3.18|1.00|0.0497
72334278|NCT01559259|144191646|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|71.1|||<|0.001|TWO_SIDED|95.0|55.82|86.38||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||12 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||86.38|55.82|<0.001
72334279|NCT01559259|144191646|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|68.31|||<|0.001|TWO_SIDED|95.0|52.88|83.74||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||12 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||83.74|52.88|<0.001
72334280|NCT01559259|144191646|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|69.98|||<|0.001|TWO_SIDED|95.0|54.47|85.48||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||12 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||85.48|54.47|<0.001
72334281|NCT01559259|144191646|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|65.95|||<|0.001|TWO_SIDED|95.0|50.16|81.74||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||12 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||81.74|50.16|<0.001
72425112|NCT01003184|144361510|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.21||||0.0074|TWO_SIDED|95.0|1.24|3.96|||Regression, Logistic|||Logistic regression model includes independent variables treatment group, use of SU (yes/no), and baseline HbA1c.||3.96|1.24|0.0074
72425113|NCT01003184|144361511|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.89||||0.0002|TWO_SIDED|95.0|2.1|11.35|||Regression, Logistic|||Logistic regression model includes independent variables treatment group, use of SU (yes/no), and baseline HbA1c.||11.35|2.10|0.0002
72425114|NCT01003184|144361512|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.257||0.6993|TWO_SIDED|95.0|-0.41|0.61|||ANCOVA|||ANCOVA model includes treatment group, baseline value, use of SU (yes/no) and baseline HbA1c stratum as factors.||0.61|-0.41|0.6993
72425115|NCT01003184|144361513|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-4.72|STANDARD_ERROR_OF_MEAN|1.853||0.0116|TWO_SIDED|95.0|-8.37|-1.07|||Mixed Models Analysis|||Mixed model repeated measures (MMRM) includes baseline value as covariate, study treatment, use of SU (yes/no), baseline HbA1c stratum, week of visit and treatment-by-week interaction as fixed effects and patient and error as random effects.||-1.07|-8.37|0.0116
72334282|NCT01559259|144191646|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|5.25||||0.265|TWO_SIDED|95.0|-3.92|14.41||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||12 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||14.41|-3.92|0.265
72334283|NCT01559259|144191646|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|1.85||||0.71|TWO_SIDED|95.0|-7.82|11.53||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||12 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||11.53|-7.82|0.710
72334284|NCT01559259|144191646|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|3.99||||0.416|TWO_SIDED|95.0|-5.52|13.49||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||12 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||13.49|-5.52|0.416
72425116|NCT01003184|144361514|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.45|STANDARD_ERROR_OF_MEAN|1.179||0.7034|TWO_SIDED|95.0|-2.77|1.88|||Mixed Models Analysis|||Mixed model repeated measures (MMRM) includes baseline value as covariate, study treatment, use of SU (yes/no), baseline HbA1c stratum, week of visit and treatment-by-week interaction as fixed effects and patient and error as random effects.||1.88|-2.77|0.7034
72425117|NCT01003184|144361515|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.09||0.1061|TWO_SIDED|95.0|-0.32|0.03|||ANCOVA|||ANCOVA model includes treatment group, baseline value, use of SU (yes/no) and baseline HbA1c stratum as factors.||0.03|-0.32|0.1061
72425118|NCT01003184|144361516|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.02||0.4638|TWO_SIDED|95.0|-0.05|0.02|||ANCOVA|||ANCOVA model includes treatment group, baseline value, use of SU (yes/no) and baseline HbA1c stratum as factors.||0.02|-0.05|0.4638
72425119|NCT01003184|144361517|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.07|STANDARD_ERROR_OF_MEAN|0.107||0.4967|TWO_SIDED|95.0|-0.14|0.28|||ANCOVA|||ANCOVA model includes treatment group, baseline value, use of SU (yes/no) and baseline HbA1c stratum as factors.||0.28|-0.14|0.4967
72425120|NCT01003184|144361518|SUPERIORITY_OR_OTHER||Ratio|0.58|STANDARD_ERROR_OF_MEAN|0.322||0.3247|TWO_SIDED|95.0|0.19|1.72|||Poisson regression|||The number of episodes by patient were compared between treatment groups using a poisson model with effects for treatment and baseline HbA1c and the logarithm of the days of exposure as the offset variable.||1.72|0.19|0.3247
72334285|NCT01559259|144191647|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.28|||<|0.001|TWO_SIDED|95.0|0.17|0.45||p-value was calculated using PH model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Proportional hazards model|||Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo), p-value, HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model with treatment, baseline categorical pain severity rating and gender terms used as covariates.||0.45|0.17|<0.001
72425121|NCT02563522|144361536|OTHER||Mean Difference (Final Values)|18.7||||0.3455|TWO_SIDED|95.0|-12.37|45.81|||Fisher Exact|No imputation was performed for subjects with missing response data||The statistical hypotheses were H0: Pt = Pc versus Ha: Pt ≠ Pc, where Pt and Pc are the proportions of subjects with a confirmed target would closure by the 4-month follow-up for Active (Engensis) and Control (Placebo) groups, respectively. The hypothesis testing was a two-sided alpha of 0.05||45.81|-12.37|0.3455
72425122|NCT03820323|144361557|SUPERIORITY||Risk Ratio (RR)|0.99||||0.55|TWO_SIDED|95.0|0.94|1.03|||Modified Poisson regression|||||1.03|0.94|0.55
72334286|NCT01559259|144191647|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.24|||<|0.001|TWO_SIDED|95.0|0.15|0.39||p-value was calculated using PH model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Proportional hazards model|||Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo), p-value, HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model with treatment, baseline categorical pain severity rating and gender terms used as covariates.||0.39|0.15|<0.001
72425123|NCT03820323|144361558|SUPERIORITY||Risk Ratio (RR)|0.86||||0.28|TWO_SIDED|95.0|0.66|1.13|||Modified Poission regression|||||1.13|0.66|0.28
72425124|NCT01107743|144361567|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.812|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Gender. The null hypothesis is there is no difference between male and female in the Incidence Rate of Treatment Related Adverse Events(TRAEs)."||||=0.812
72425125|NCT01107743|144361568|SUPERIORITY_OR_OTHER_LEGACY||||||=|1|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Age. The null hypothesis is there is no difference between \<65 years and \>=65 years in the Incidence Rate of Treatment Related Adverse Events(TRAEs)."||||=1.000
72334287|NCT01559259|144191647|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.21|||<|0.001|TWO_SIDED|95.0|0.13|0.35||p-value was calculated using PH model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Proportional hazards model|||Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo), p-value, HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model with treatment, baseline categorical pain severity rating and gender terms used as covariates.||0.35|0.13|<0.001
72334288|NCT01559259|144191647|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.25|||<|0.001|TWO_SIDED|95.0|0.15|0.41||p-value was calculated using PH model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Proportional hazards model|||Treatment difference (Ibuprofen 400 mg - placebo), p-value, HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model with treatment, baseline categorical pain severity rating and gender terms used as covariates.||0.41|0.15|<0.001
72334289|NCT01559259|144191647|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.12||||0.549|TWO_SIDED|95.0|0.77|1.63||p-value was calculated using PH model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Proportional hazards model|||Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg), p-value, HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model with treatment, baseline categorical pain severity rating and gender terms used as covariates.||1.63|0.77|0.549
72334290|NCT01559259|144191647|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.97||||0.863|TWO_SIDED|95.0|0.66|1.42||p-value was calculated using PH model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Proportional hazards model|||Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg), p-value, HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model with treatment, baseline categorical pain severity rating and gender terms used as covariates.||1.42|0.66|0.863
72334291|NCT01559259|144191647|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.86||||0.454|TWO_SIDED|95.0|0.57|1.28||p-value was calculated using PH model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Proportional hazards model|||Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg), p-value, HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model with treatment, baseline categorical pain severity rating and gender terms used as covariates.||1.28|0.57|0.454
72425126|NCT01107743|144361569|SUPERIORITY_OR_OTHER_LEGACY||||||=|1|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Hypertension. The null hypothesis is there is no difference between with Hypetension and without Hypertension in the Incidence Rate of Treatment Related Adverse Events(TRAEs)."||||=1.000
72425127|NCT01107743|144361570|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.112|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Hypertension severity. The null hypothesis is there is no difference among ClassⅠHypertension, ClassⅡ Hypertension, and ClassⅢ Hypertension in the Incidence Rate of Treatment Related Adverse Events(TRAEs)."||||=0.112
72334292|NCT01559259|144191648|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-41.07|||<|0.001|TWO_SIDED|95.0|-59.56|-22.58||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||1.5 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-22.58|-59.56|<0.001
72425128|NCT01107743|144361571|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.093|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Angina Pectoris. The null hypothesis is there is no difference between with Angina Pectoris and without Angina Pectoris in the Incidence Rate of Treatment Related Adverse Events(TRAEs)."||||=0.093
72425129|NCT01107743|144361572|SUPERIORITY_OR_OTHER_LEGACY||||||=|1|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Hypercholesterolemia. The null hypothesis is there is no difference between with Hypercholesterolemia and without Hypercholesterolemia in the Incidence Rate of Treatment Related Adverse Events(TRAEs)."||||=1.000
72425130|NCT01107743|144361573|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.839|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Hypercholesterolemia expression type. The null hypothesis is there is no difference among expression type Ⅰ, expression type Ⅱa, expression type Ⅱb, expression type Ⅲ, expression type, expression type Ⅳ, and expression type Ⅴ in the Incidence Rate of Treatment Related Adverse Events(TRAEs)."||||=0.839
72425131|NCT01107743|144361574|SUPERIORITY_OR_OTHER_LEGACY||||||=|1|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Familial Hypercholesterolemia. The null hypothesis is there is no difference between with Familial Hypercholesterolemia and without Familial Hypercholesterolemia in the Incidence Rate of Treatment Related Adverse Events(TRAEs)."||||=1.000
72334293|NCT01559259|144191648|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-40.98|||<|0.001|TWO_SIDED|95.0|-59.41|-22.56||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||1.5 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-22.56|-59.41|<0.001
72334294|NCT01559259|144191648|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-38.64|||<|0.001|TWO_SIDED|95.0|-57.49|-19.79||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||1.5 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-19.79|-57.49|<0.001
72334295|NCT01559259|144191648|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-38.11|||<|0.001|TWO_SIDED|95.0|-56.94|-19.28||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||1.5 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-19.28|-56.94|<0.001
72334296|NCT01559259|144191648|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-3.13||||0.274|TWO_SIDED|95.0|-8.67|2.4||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||1.5 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||2.40|-8.67|0.274
72425132|NCT01107743|144361575|SUPERIORITY_OR_OTHER_LEGACY||||||=|1|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Hepatic Dysfunction. The null hypothesis is there is no difference between with Hepatic Dysfunction and without Hepatic Dysfunction in the Incidence Rate of Treatment Related Adverse Events(TRAEs)."||||=1.000
72425133|NCT01107743|144361576|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.644|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Renal Dysfunction. The null hypothesis is there is no difference between with Renal Dysfunction and without Renal Dysfunction in the Incidence Rate of Treatment Related Adverse Events(TRAEs)."||||=0.644
72425134|NCT01107743|144361577|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.155|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Complications. The null hypothesis is there is no difference between with Complications and without Complications in the Incidence Rate of Treatment Related Adverse Events(TRAEs)."||||=0.155
72334297|NCT01559259|144191648|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-2.89||||0.304|TWO_SIDED|95.0|-8.4|2.62||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||1.5 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||2.62|-8.40|0.304
72334298|NCT01559259|144191648|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-0.96||||0.769|TWO_SIDED|95.0|-7.41|5.49||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||1.5 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||5.49|-7.41|0.769
72425135|NCT01107743|144361578|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.305|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Concomitant Drugs. The null hypothesis is there is no difference between with Concomitant Drugs and without Concomitant Drugs in the Incidence Rate of Treatment Related Adverse Events(TRAEs)."||||=0.305
72334299|NCT01559259|144191648|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-71.19|||<|0.001|TWO_SIDED|95.0|-88.0|-54.38||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||2 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-54.38|-88.00|<0.001
72334300|NCT01559259|144191648|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-66.99|||<|0.001|TWO_SIDED|95.0|-84.26|-49.72||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||2 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-49.72|-84.26|<0.001
72425136|NCT01107743|144361579|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.234|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Gender. The null hypothesis is there is no difference between males and females in the participants of responders."||||=0.234
72425137|NCT01107743|144361580|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.439|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Age. The null hypothesis is there is no difference between \<65 years and \>=65 years in the participants of responders."||||=0.439
72425138|NCT01107743|144361581|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.761|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Hypertension severity. The null hypothesis is there is no difference among ClassⅠHypertension, ClassⅡ Hypertension, and ClassⅢ Hypertension in the participants of responders."||||=0.761
72425139|NCT01107743|144361582|SUPERIORITY_OR_OTHER_LEGACY||||||=|1|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Hepatic Dysfunction. The null hypothesis is there is no difference between with and without Hepatic Dysfunction in the participants of responders."||||=1.000
72425140|NCT01107743|144361583|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.31|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Renal Dysfunction. The null hypothesis is there is no difference between with and without Renal Dysfunction in the participants of responders."||||=0.310
72425141|NCT01107743|144361584|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.251|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Complications. The null hypothesis is there is no difference between with and without Complications in the participants of responders."||||=0.251
72425142|NCT01107743|144361585|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.756|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Concomitant Drugs. The null hypothesis is there is no difference between with and without Concomitant Drugs in the participants of responders."||||=0.756
72425143|NCT01107743|144361586|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.706|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Gender. The null hypothesis is there is no difference between males and females in the participants of responders."||||=0.706
72425144|NCT01107743|144361587|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.192|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Age. The null hypothesis is there is no difference between \<65 years and \>=65 years in the participants of responders."||||=0.192
72334301|NCT01559259|144191648|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-67.47|||<|0.001|TWO_SIDED|95.0|-84.75|-50.19||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||2 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-50.19|-84.75|<0.001
72425145|NCT01107743|144361588|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.005|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Angina Pectoris Severity. The null hypothesis is there is no difference among Class1, Class2, Class3, and Class4 in the participants of responders."||||=0.005
72425146|NCT01107743|144361589|SUPERIORITY_OR_OTHER_LEGACY||||||=|1|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Hepatic Dysfunction. The null hypothesis is there is no difference between with and without Hepatic Dysfunction in the participants of responders."||||=1.000
72334302|NCT01559259|144191648|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-62.76|||<|0.001|TWO_SIDED|95.0|-80.45|-45.07||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||2 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-45.07|-80.45|<0.001
72334303|NCT01559259|144191648|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-8.53||||0.021|TWO_SIDED|95.0|-15.55|-1.5||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||2 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-1.50|-15.55|0.021
72334304|NCT01559259|144191648|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-3.99||||0.337|TWO_SIDED|95.0|-12.05|4.07||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||2 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||4.07|-12.05|0.337
72334305|NCT01559259|144191648|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-5.26||||0.204|TWO_SIDED|95.0|-13.28|2.76||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||2 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||2.76|-13.28|0.204
72334306|NCT01559259|144191648|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-77.89|||<|0.001|TWO_SIDED|95.0|-92.29|-63.49||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||3 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-63.49|-92.29|<0.001
72334307|NCT01559259|144191648|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-71.65|||<|0.001|TWO_SIDED|95.0|-86.71|-56.58||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||3 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-56.58|-86.71|<0.001
72425147|NCT01107743|144361590|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.596|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Renal Dysfunction. The null hypothesis is there is no difference between with and without Renal Dysfunction in the participants of responders."||||=0.596
72334308|NCT01559259|144191648|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-72.87|||<|0.001|TWO_SIDED|95.0|-88.06|-57.68||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||3 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-57.68|-88.06|<0.001
72334309|NCT01559259|144191648|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-67.2|||<|0.001|TWO_SIDED|95.0|-82.87|-51.52||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||3 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-51.52|-82.87|<0.001
72334310|NCT01559259|144191648|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-10.71||||0.007|TWO_SIDED|95.0|-18.2|-3.21||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||3 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-3.21|-18.20|0.007
72334311|NCT01559259|144191648|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-3.99||||0.385|TWO_SIDED|95.0|-12.86|4.88||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||3 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||4.88|-12.86|0.385
72425148|NCT01107743|144361591|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.252|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Complications. The null hypothesis is there is no difference between with and without Complications in the participants of responders."||||=0.252
72425149|NCT01107743|144361592|SUPERIORITY_OR_OTHER_LEGACY||||||=|1|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Concomitant Drugs. The null hypothesis is there is no difference between with and without Concomitant Drugs in the participants of responders."||||=1.000
72425150|NCT01107743|144361593|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.518|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Gender. The null hypothesis is there is no difference between males and females in the participants of responders."||||=0.518
72425151|NCT01107743|144361594|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.645|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Age. The null hypothesis is there is no difference between \<65 years and \>=65 years in the participants of responders."||||=0.645
72425152|NCT01107743|144361595|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.13|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Hypercholesterolemia expression type. The null hypothesis is there is no difference among expression type Ⅰ, expression type Ⅱa, expression type Ⅱb, expression type Ⅲ, expression type, expression type Ⅳ, and expression type Ⅴ in the participants of responders."||||=0.130
72425153|NCT01107743|144361596|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.185|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Hepatic Dysfunction. The null hypothesis is there is no difference between with and without Hepatic Dysfunction in the participants of responders."||||=0.185
72425154|NCT01107743|144361597|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.714|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Renal Dysfunction. The null hypothesis is there is no difference between with and without Renal Dysfunction in the participants of responders."||||=0.714
72425155|NCT01107743|144361598|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.835|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Complications. The null hypothesis is there is no difference between with and without Complications in the participants of responders."||||=0.835
72425156|NCT01107743|144361599|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.252|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Concomitant Drugs. The null hypothesis is there is no difference between with and without Concomitant Drugs in the participants of responders."||||=0.252
72425157|NCT00308737|144361600|NON_INFERIORITY_OR_EQUIVALENCE|Comparison of TI + Usual Care to Usual Care only|Mean Difference (Final Values)|0.037|||||TWO_SIDED|95.0|0.014|0.06|||Mixed Models Analysis|Repeated measures||Mixed model repeated measures with fixed effects diabetes type, visit, pooled site and treatment and baseline FEV1 as a covariate||0.060|0.014|
72334312|NCT01559259|144191648|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-6.29||||0.162|TWO_SIDED|95.0|-14.97|2.4||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||3 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||2.40|-14.97|0.162
72425158|NCT00308737|144361601|NON_INFERIORITY_OR_EQUIVALENCE|The null hypothesis tested was that the FEV1 change from Baseline for the TI group is no greater than 50 mL/year above the change in the usual care treatment group. Assuming SD of 100 mL/y, 80% power, and 5% (1-tailed) significance level, it was determined that 50 subjects were required for each of the diabetes treatment groups. Final sample size was selected for the incidence of a \>= 15% decrease in FEV1 end point.|Mean Difference (Final Values)|0.037|||||TWO_SIDED|95.0|0.016|0.057|||ANCOVA|||ANCOVA model with treatment site, diabetes type, and baseline FEV1||0.057|0.016|
72425159|NCT00308737|144361602|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.034|||||TWO_SIDED|95.0|0.008|0.061|||Mixed Models Analysis|Repeated measures||Mixed model repeated measures with fixed effects diabetes type, visit, pooled site and treatment and baseline FVC as a covariate||0.061|0.008|
72425160|NCT00308737|144361603|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.005|||||TWO_SIDED|95.0|-0.042|0.031|||Mixed Models Analysis|Repeated measures||Mixed model repeated measures with fixed effects diabetes type, visit, pooled site, and treatment and baseline TLC as a covariate||0.031|-0.042|
72425161|NCT00308737|144361604|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.269|||||TWO_SIDED|95.0|-0.037|0.574|||Mixed Models Analysis|Repeated measures||Mixed model repeated measures with fixed effects diabetes type, visit, pooled site, and treatment and baseline TLC as a covariate||0.574|-0.037|
72425162|NCT00308737|144361605|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.6475|||||TWO_SIDED|95.0|0.3432|1.2219|||Regression, Logistic|||Logistic regression excluding non-diabetics||1.2219|0.3432|
72425163|NCT00308737|144361606|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.7504|||||TWO_SIDED|95.0|0.251|2.2431|||Regression, Logistic|||Logistic regression excluding non-diabetics||2.2431|0.2510|
72425164|NCT00308737|144361607|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.8953|||||TWO_SIDED|95.0|0.6703|1.1958|||Regression, Logistic|||Logistic regression excluding non-diabetics||1.1958|0.6703|
72425165|NCT00308737|144361608|SUPERIORITY_OR_OTHER||Odds Ratio, log|0.8509|||||TWO_SIDED|95.0|0.6722|1.077|||Regression, Logistic|||Logistic regression excluding non-diabetics||1.0770|0.6722|
72425166|NCT00308737|144361610|SUPERIORITY_OR_OTHER|||||||0.112||95.0|||||t-test, 2 sided|||Two sample t-test||||0.112
72425167|NCT00308737|144361611|NON_INFERIORITY_OR_EQUIVALENCE|The null hypothesis tested was that the difference in incidence of a decrease of ≥ 15% in FEV1 between the treatment groups not be greater than 5% for TI when compared with the usual care treatment group. Assuming an incidence rate of 15% for FEV1 and a noninferiority criterion of a 5% difference in incidence between the treatment groups, approximately 625 subjects per group were required for 80% power and an alpha of 5% (1 tailed).|Odds Ratio (OR)|-2.4767|||||TWO_SIDED|95.0|-4.5578|-0.3956|||Regression, Logistic|||Logistic regression excluding non-diabetics||-0.3956|-4.5578|
72425168|NCT02224482|144361612|SUPERIORITY|||||||0.9634|||||||Mixed Models Analysis|||||||.9634
72425169|NCT02224482|144361613|SUPERIORITY|||||||0.5214|||||||Mixed Models Analysis|||||||.5214
72425170|NCT02224482|144361614|SUPERIORITY|||||||0.4875|||||||Mixed Models Analysis|||||||.4875
72425171|NCT02224482|144361615|SUPERIORITY|||||||0.7938|||||||Mixed Models Analysis|||||||.7938
72425172|NCT02224482|144361616|SUPERIORITY|||||||0.6765|||||||Mixed Models Analysis|||||||.6765
72425173|NCT02224482|144361617|SUPERIORITY|||||||0.7061|||||||Mixed Models Analysis|||||||.7061
72425174|NCT02224482|144361618|SUPERIORITY|||||||0.7593|||||||Mixed Models Analysis|||||||.7593
72425175|NCT01225822|144361620|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.375|||<|0.0001||95.0|0.244|0.577||Dose relationship tested using a hierarchical testing procedure to preserve type I error rate at 5%. 225 mg bid was compared to 50 mg bid. If a difference significant at 5% level was found, then 150 mg bid was compared to 50 mg bid|Regression, Logistic|||BIBR 1048 225 mg bid vs. BIBR 1048 50 mg bid comparison. The primary objective of the trial was to establish a dose relationship among BIBR 1048 doses studied in the prevention of VTE. The statistical model was a logistic regression which included treatment and centre..||0.577|0.244|<0.0001
72425176|NCT01225822|144361620|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.518||||0.0015||95.0|0.344|0.778||Dose relationship tested using a hierarchical testing procedure to preserve type I error rate at 5%. 225 mg bid was compared to 50 mg bid. If a difference significant at 5% level was found, then 150 mg bid was compared to 50 mg bid|Regression, Logistic|||BIBR 1048 150 mg bid vs. BIBR 1048 50 mg bid comparison. The primary objective of the trial was to establish a dose relationship among BIBR 1048 doses studied in the prevention of VTE. The statistical model was a logistic regression which included treatment and centre..||0.778|0.344|0.0015
72334313|NCT01559259|144191648|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-76.81|||<|0.001|TWO_SIDED|95.0|-91.35|-62.27||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||4 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-62.27|-91.35|<0.001
72334314|NCT01559259|144191648|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-70.6|||<|0.001|TWO_SIDED|95.0|-85.79|-55.41||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||4 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-55.41|-85.79|<0.001
72334315|NCT01559259|144191648|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-71.66|||<|0.001|TWO_SIDED|95.0|-87.0|-56.31||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||4 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-56.31|-87.00|<0.001
72334316|NCT01559259|144191648|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-65.19|||<|0.001|TWO_SIDED|95.0|-81.03|-49.34||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||4 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-49.34|-81.03|<0.001
72334317|NCT01559259|144191648|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-11.7||||0.007|TWO_SIDED|95.0|-19.86|-3.55||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||4 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-3.55|-19.86|0.007
72334318|NCT01559259|144191648|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-4.94||||0.31|TWO_SIDED|95.0|-14.34|4.46||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||4 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||4.46|-14.34|0.310
72425177|NCT01225822|144361620|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.94||||0.7856||95.0|0.599|1.473|||Regression, Logistic|||BIBR 1048 300 mg qd vs. BIBR 1048 150 mg bid comparison. Secondary analysis to compare once daily dosing vs. twice daily dosing. . The statistical model was a logistic regression which included treatment and centre.||1.473|0.599|0.7856
72334319|NCT01559259|144191648|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-7.36||||0.126|TWO_SIDED|95.0|-16.63|1.9||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||4 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||1.90|-16.63|0.126
72334320|NCT01559259|144191648|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-75.64|||<|0.001|TWO_SIDED|95.0|-90.35|-60.93||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||5 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-60.93|-90.35|<0.001
72334321|NCT01559259|144191648|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-66.43|||<|0.001|TWO_SIDED|95.0|-81.99|-50.88||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||5 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-50.88|-81.99|<0.001
72334322|NCT01559259|144191648|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-69.33|||<|0.001|TWO_SIDED|95.0|-84.96|-53.71||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||5 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-53.71|-84.96|<0.001
72425178|NCT01225822|144361620|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.469||||0.0007||95.0|0.302|0.727|||Regression, Logistic|||BIBR 1048 225 mg bid vs. Enoxaparin 40 mg qd comparison. Secondary analysis, active control used as reference. The statistical model was a logistic regression which included treatment and centre.||0.727|0.302|0.0007
72425179|NCT01225822|144361620|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.647||||0.0401||95.0|0.427|0.98|||Regression, Logistic|||BIBR 1048 150 mg bid vs. Enoxaparin 40 mg qd comparison. Secondary analysis, active control used as reference. The statistical model was a logistic regression which included treatment and centre.||0.98|0.427|0.0401
72425180|NCT01225822|144361620|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.249||||0.2446||95.0|0.859|1.817|||Regression, Logistic|||BIBR 1048 50 mg bid vs. Enoxaparin 40 mg qd comparison. Secondary analysis, active control used as reference. The statistical model was a logistic regression which included treatment and centre.||1.817|0.859|0.2446
72425181|NCT01225822|144361621|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.375|||<|0.0001||95.0|0.244|0.577||Dose relationship tested using a hierarchical testing procedure to preserve type I error rate at 5%. 225 mg bid was compared to 50 mg bid. If a difference significant at 5% level was found, then 150 mg bid was compared to 50 mg bid|Regression, Logistic|||BIBR 1048 225 mg bid vs. BIBR 1048 50 mg bid comparison. The primary objective of the trial was to establish a dose relationship among BIBR 1048 doses studied in the prevention of VTE. The statistical model was a logistic regression which included treatment and centre..||0.577|0.244|<0.0001
72334323|NCT01559259|144191648|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-65.19|||<|0.001|TWO_SIDED|95.0|-81.03|-49.34||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||5 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-49.34|-81.03|<0.001
72334324|NCT01559259|144191648|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-10.61||||0.016|TWO_SIDED|95.0|-19.02|-2.19||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||5 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-2.19|-19.02|0.016
72334325|NCT01559259|144191648|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-0.69||||0.895|TWO_SIDED|95.0|-10.69|9.32||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||5 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||9.32|-10.69|0.895
72334326|NCT01559259|144191648|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-5.09||||0.308|TWO_SIDED|95.0|-14.8|4.62||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||5 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||4.62|-14.80|0.308
72334327|NCT01559259|144191648|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-71.36|||<|0.001|TWO_SIDED|95.0|-86.58|-56.13||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||6 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-56.13|-86.58|<0.001
72425182|NCT01225822|144361621|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.518||||0.0015||95.0|0.344|0.778||Dose relationship tested using a hierarchical testing procedure to preserve type I error rate at 5%. 225 mg bid was compared to 50 mg bid. If a difference significant at 5% level was found, then 150 mg bid was compared to 50 mg bid|Regression, Logistic|||BIBR 1048 150 mg bid vs. BIBR 1048 50 mg bid comparison. The primary objective of the trial was to establish a dose relationship among BIBR 1048 doses studied in the prevention of VTE. The statistical model was a logistic regression which included treatment and centre..||0.778|0.344|0.0015
72334328|NCT01559259|144191648|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-62.11|||<|0.001|TWO_SIDED|95.0|-78.04|-46.19||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||6 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-46.19|-78.04|<0.001
72334329|NCT01559259|144191648|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-64.57|||<|0.001|TWO_SIDED|95.0|-80.64|-48.5||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||6 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-48.50|-80.64|<0.001
72334330|NCT01559259|144191648|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-59.84|||<|0.001|TWO_SIDED|95.0|-76.12|-43.55||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||6 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-43.55|-76.12|<0.001
72334331|NCT01559259|144191648|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-11.49||||0.028|TWO_SIDED|95.0|-21.63|-1.35||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||6 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-1.35|-21.63|0.028
72334332|NCT01559259|144191648|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-1.88||||0.747|TWO_SIDED|95.0|-13.15|9.38||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||6 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||9.38|-13.15|0.747
72334333|NCT01559259|144191648|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-5.88||||0.303|TWO_SIDED|95.0|-16.88|5.12||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||6 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||5.12|-16.88|0.303
72425183|NCT01225822|144361621|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.94||||0.7856||95.0|0.599|1.473|||Regression, Logistic|||BIBR 1048 300 mg qd vs. BIBR 1048 150 mg bid comparison. Secondary analysis to compare once daily dosing vs. twice daily dosing. . The statistical model was a logistic regression which included treatment and centre.||1.473|0.599|0.7856
72425184|NCT01225822|144361621|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.469||||0.0007||95.0|0.302|0.727|||Regression, Logistic|||BIBR 1048 225 mg bid vs. Enoxaparin 40 mg qd comparison. Secondary analysis, active control used as reference. The statistical model was a logistic regression which included treatment and centre.||0.727|0.302|0.0007
72334334|NCT01559259|144191648|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-62.49|||<|0.001|TWO_SIDED|95.0|-78.64|-46.34||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||7 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-46.34|-78.64|<0.001
72334335|NCT01559259|144191648|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-60.09|||<|0.001|TWO_SIDED|95.0|-76.15|-44.02||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||7 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-44.02|-76.15|<0.001
72334336|NCT01559259|144191648|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-63.45|||<|0.001|TWO_SIDED|95.0|-79.64|-47.27||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||7 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-47.27|-79.64|<0.001
72334337|NCT01559259|144191648|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-53.41|||<|0.001|TWO_SIDED|95.0|-70.1|-36.72||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||7 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-36.72|-70.10|<0.001
72334338|NCT01559259|144191648|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-9.14||||0.137|TWO_SIDED|95.0|-21.18|2.9||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||7 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||2.90|-21.18|0.137
72334339|NCT01559259|144191648|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-6.34||||0.311|TWO_SIDED|95.0|-18.39|5.71||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||7 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||5.71|-18.39|0.311
72334340|NCT01559259|144191648|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-11.23||||0.067|TWO_SIDED|95.0|-22.97|0.52||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||7 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||0.52|-22.97|0.067
72334341|NCT01559259|144191648|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-51.54|||<|0.001|TWO_SIDED|95.0|-68.42|-34.66||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||8 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-34.66|-68.42|<0.001
72334342|NCT01559259|144191648|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-57.01|||<|0.001|TWO_SIDED|95.0|-73.27|-40.76||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||8 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-40.76|-73.27|<0.001
72334343|NCT01559259|144191648|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-53.21|||<|0.001|TWO_SIDED|95.0|-70.16|-36.26||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||8 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-36.26|-70.16|<0.001
72334344|NCT01559259|144191648|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-47.82|||<|0.001|TWO_SIDED|95.0|-64.81|-30.83||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||8 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-30.83|-64.81|<0.001
72334345|NCT01559259|144191648|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-3.52||||0.604|TWO_SIDED|95.0|-16.89|9.85||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||8 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||9.85|-16.89|0.604
72334346|NCT01559259|144191648|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-8.78||||0.184|TWO_SIDED|95.0|-21.5|3.94||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||8 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||3.94|-21.50|0.184
72334347|NCT01559259|144191648|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-6.43||||0.34|TWO_SIDED|95.0|-19.56|6.7||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||8 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||6.70|-19.56|0.340
72334348|NCT01559259|144191648|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-40.27|||<|0.001|TWO_SIDED|95.0|-57.67|-22.88||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||9 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-22.88|-57.67|<0.001
72425185|NCT01225822|144361621|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.647||||0.0401||95.0|0.427|0.98|||Regression, Logistic|||BIBR 1048 150 mg bid vs. Enoxaparin 40 mg qd comparison. Secondary analysis, active control used as reference. The statistical model was a logistic regression which included treatment and centre.||0.98|0.427|0.0401
72425186|NCT01225822|144361621|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.249||||0.2446||95.0|0.859|1.817|||Regression, Logistic|||BIBR 1048 50 mg bid vs. Enoxaparin 40 mg qd comparison. Secondary analysis, active control used as reference. The statistical model was a logistic regression which included treatment and centre.||1.817|0.859|0.2446
72425187|NCT01225822|144361622|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.334||||0.0373||95.0|0.199|0.938|||Regression, Logistic|||BIBR 1048 225 mg bid vs. BIBR 1048 50 mg bid, same methodology as primary endpoint.||0.938|0.199|0.0373
72425188|NCT01225822|144361622|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.837||||0.6659||95.0|0.374|1.875|||Regression, Logistic|||BIBR 1048 150 mg bid vs. BIBR 1048 50 mg bid, same methodology as primary endpoint.||1.875|0.374|0.6659
72425189|NCT01225822|144361622|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.505||||0.1882||95.0|0.183|1.397|||Regression, Logistic|||BIBR 1048 150 mg bid vs. BIBR 1048 300 mg qd, same methodology as primary endpoint.||1.397|0.183|0.1882
72425190|NCT01225822|144361622|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.805||||0.5566||95.0|0.39|1.66|||Regression, Logistic|||BIBR 1048 50 mg bid vs. Enoxaparin 40 mg qd, same methodology as primary endpoint.||1.66|0.39|0.5566
72425191|NCT01225822|144361622|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.674||||0.3253||95.0|0.307|1.48|||Regression, Logistic|||BIBR 1048 150 mg bid vs. Enoxaparin 40 mg qd, same methodology as primary endpoint.||1.48|0.307|0.3253
72425192|NCT01225822|144361622|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.269||||0.0114||95.0|0.097|0.744|||Regression, Logistic|||BIBR 1048 225 mg bid vs. Enoxaparin 40 mg qd, same methodology as primary endpoint.||0.744|0.097|0.0114
72425193|NCT01225822|144361623|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.332||||0.036||95.0|0.118|0.931|||Regression, Logistic|||BIBR 1048 225 mg bid vs. BIBR 1048 50 mg bid, same methodology as primary endpoint.||0.931|0.118|0.036
72425194|NCT01225822|144361623|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.687||||0.3884||95.0|0.293|1.611|||Regression, Logistic|||BIBR 1048 150 mg bid vs. BIBR 1048 50 mg bid, same methodology as primary endpoint.||1.611|0.293|0.3884
72425195|NCT01225822|144361623|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.616||||0.3674||95.0|0.215|1.766|||Regression, Logistic|||BIBR 1048 150 mg bid vs. BIBR 1048 300 mg qd, same methodology as primary endpoint.||1.766|0.215|0.3674
72425196|NCT01225822|144361623|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.809||||0.5663||95.0|0.393|1.668|||Regression, Logistic|||BIBR 1048 50 mg bid vs. Enoxaparin 40 mg qd, same methodology as primary endpoint.||1.668|0.393|0.5663
72425197|NCT01225822|144361623|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.556||||0.1678||95.0|0.242|1.28|||Regression, Logistic|||BIBR 1048 150 mg bid vs. Enoxaparin 40 mg qd, same methodology as primary endpoint.||1.28|0.242|0.1678
72425198|NCT01225822|144361623|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.269||||0.0113||95.0|0.097|0.743|||Regression, Logistic|||BIBR 1048 225 mg bid vs. Enoxaparin 40 mg qd, same methodology as primary endpoint.||0.743|0.097|0.0113
72425199|NCT01225822|144361624|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|15.818||||0.0077||95.0|2.077|120.474|||Regression, Logistic|||BIBR 1048 225 mg bid vs. BIBR 1048 50 mg bid, same methodology as for primary endpoint||120.474|2.077|0.0077
72425200|NCT01225822|144361624|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|16.907||||0.0062||95.0|2.229|128.238|||Regression, Logistic|||BIBR 1048 150 mg bid vs. BIBR 1048 50 mg bid, same methodology as for primary endpoint||128.238|2.229|0.0062
72425201|NCT01225822|144361624|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.136||||0.7192||95.0|0.567|2.276|||Regression, Logistic|||BIBR 1048 150 mg bid vs. BIBR 1048 300 mg qd, same methodology as for primary endpoint||2.276|0.567|0.7192
72425202|NCT01225822|144361624|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.121||||0.0472||95.0|0.015|0.974|||Regression, Logistic|||BIBR 1048 50 mg bid vs. Enoxaparin 40 mg qd, same methodology as for primary endpoint||0.974|0.015|0.0472
72334349|NCT01559259|144191648|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-47.24|||<|0.001|TWO_SIDED|95.0|-64.21|-30.27||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||9 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-30.27|-64.21|<0.001
72425203|NCT01225822|144361624|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.049||||0.1043||95.0|0.862|4.868|||Regression, Logistic|||BIBR 1048 150 mg bid vs. Enoxaparin 40 mg qd, same methodology as for primary endpoint||4.868|0.862|0.1043
72425204|NCT01225822|144361624|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.917||||0.1448||95.0|0.799|4.597|||Regression, Logistic|||BIBR 1048 225 mg bid vs. Enoxaparin 40 mg qd, same methodology as for primary endpoint||4.597|0.799|0.1448
72425205|NCT01225822|144361626|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|16.871||||0.0063|TWO_SIDED|95.0|2.221|128.142|||Regression, Logistic|||||128.142|2.221|0.0063
72425206|NCT01225822|144361626|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|22.338||||0.0025|TWO_SIDED|95.0|2.983|167.268|||Regression, Logistic|||||167.268|2.983|0.0025
72425207|NCT01225822|144361626|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.919||||0.7973|TWO_SIDED|95.0|0.483|1.75|||Regression, Logistic|||||1.750|0.483|0.7973
72425208|NCT01225822|144361626|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.068||||0.0097|TWO_SIDED|95.0|0.009|0.522|||Regression, Logistic|||||0.522|0.009|0.0097
72425209|NCT01225822|144361626|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.522||||0.2375|TWO_SIDED|95.0|0.758|3.058|||Regression, Logistic|||||3.058|0.758|0.2375
72425210|NCT01225822|144361626|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.15||||0.7104|TWO_SIDED|95.0|0.55|2.403|||Regression, Logistic|||||2.403|0.550|0.7104
72425211|NCT01407354|144361691|SUPERIORITY_OR_OTHER_LEGACY|||||||0.05|||||||Chi-squared, Corrected|||||||0.05
72425212|NCT01407354|144361691|SUPERIORITY_OR_OTHER_LEGACY|||||||0.024|||||||Wilcoxon (Mann-Whitney)|threshold p value for statistical significance=0.05||||||0.024
72425213|NCT02120664|144361710|SUPERIORITY_OR_OTHER||R squared|0.907|||||TWO_SIDED||||||Regression, Linear|||||||
72425214|NCT02120664|144361711|SUPERIORITY_OR_OTHER||Coefficient of Variation|2.53|||||TWO_SIDED|||||||||||||
72425215|NCT02120664|144361711|SUPERIORITY_OR_OTHER||Coefficient of Variation|6.69|||||TWO_SIDED|||||||||||||
72425216|NCT04524598|144361729|SUPERIORITY||t|-1.911||||0.06|TWO_SIDED||||||Mixed Models Analysis|||A linear mixed-effects model (LMM) analysis was implemented on an averaged imputed dataset to evaluate main effects of Group (Spark, Control) and Week (0-5), and the Group x Week interaction. Group and Week were entered as fixed factors. Spark version, and assessment completion days since baseline were included as fixed factors to control for effects of app version and differences in time between completion of successive weekly assessments.||||0.06
72425217|NCT04524598|144361729|SUPERIORITY||t|-2.546||||0.01|TWO_SIDED||||||Mixed Models Analysis|||We used a Per Protocol approach that included participants who completed the PHQ at baseline and each week. A linear mixed-effects model (LMM) analysis was implemented on an averaged imputed dataset to evaluate main effects of Group (Spark, Control) and Week (0-5), and the Group x Week interaction.||||0.01
72425218|NCT04524598|144361732|SUPERIORITY||F|1.46||||0.23|TWO_SIDED||||||ANOVA|||We conducted a repeated measures ANOVA (Group x Time) on GAD-7 scores to compare the change in anxiety symptoms from Baseline to Post treatment for Phase II participants who had a baseline PHQ-8 score \>= 10. The interaction term is presented.||||0.23
72425219|NCT04524598|144361732|SUPERIORITY||F|2.59||||0.11|TWO_SIDED||||||ANOVA|||We conducted a repeated measures ANOVA (Group x Time) on the PROMIS - General Health Score to compare the change in general health from Baseline to Post treatment for Phase II participants who had a baseline PHQ-8 score \>= 10. The interaction term is reported.||||0.11
72425220|NCT04524598|144361733|SUPERIORITY||F|0.94||||0.33|TWO_SIDED||||||ANOVA|||We conducted a repeated measures ANOVA (Time x Group) on the MFQ to compare the change in parent report of depressive symptoms from Baseline to Post treatment for Phase II participants who had a baseline PHQ-8 score \>= 10. The interaction term is presented.||||0.33
72425221|NCT04524598|144361733|SUPERIORITY||F|0.02||||0.9|TWO_SIDED||||||ANOVA|||We conducted a repeated measures ANOVA (Group x Time) on the PROMIS Parent Proxy - General Health Score to compare the change in parent reported general health from Baseline to Post treatment for Phase II participants who had a baseline PHQ-8 score \>= 10. The interaction term is reported.||||0.90
72425222|NCT03556358|144361739|EQUIVALENCE|"Two one-sided hypothesis tests were performed for pCR in order to show that TX05 is equivalent to Herceptin:~* TEST 1: H0a: θ1 / θ2 \> 1.325 vs. H1a: θ1 / θ2 \< 1.325~* TEST 2: H0b: θ1 / θ2 \< 0.755 vs. H1b: θ1 / θ2 \> 0.755~Where θ1 is the proportion of pCR for subjects randomized to TX05 group, θ2 is the proportion of pCR for subjects randomized to Herceptin. Equivalence was concluded if the 95% CI of the risk ratio is completely contained within the pre-defined interval \[0.755, 1.325\]."|Risk Ratio (RR)|1.0783|||||TWO_SIDED|95.0|0.9185|1.2659||||||||1.2659|0.9185|
72425223|NCT04195880|144361745|SUPERIORITY||||||<|0.05|TWO_SIDED|5.0|||||negative-binomial regression coefficient|||We assumed the average monthly pre-intervention hospitalization rates of intervention and control CLCs were equal, so only average monthly post-intervention hospitalization rates might diverge. Each CLC had its own start month and contributed 18 months pre-intervention and 18 months post-intervention. Hospitalizations rates were modeled using a multilevel negative-binomial regression because it allows for over-dispersion, which is commonly observed with medical events such as a count.||||<.05
72425224|NCT01351025|144361747|SUPERIORITY_OR_OTHER_LEGACY|||||||0.94|TWO_SIDED|||||Two-sided p-values of \< 0.05 without adjustments for multiple testing were considered statistically significant.|Wilcoxon (Mann-Whitney)|Exact Wilcoxon rank sum test was used||The null hypothesis is that there is no difference between arm A and arm B in the differences of the changes (\[week 44 - week 24\] - \[week 20 - baseline\]) in log10 IL-6||||0.94
72425225|NCT01351025|144361748|SUPERIORITY_OR_OTHER_LEGACY|||||||0.495|TWO_SIDED|||||Two-sided p-values of \< 0.05 without adjustments for multiple testing were considered statistically significant.|Wilcoxon (Mann-Whitney)|exact Wilcoxon rank sun test was used||The null hypothesis is that there is no difference between arm A and arm B in the differences of the changes (\[week 44 - week 24\] - \[week 20 - baseline\]) in CD4+ T-cell activation percent (% CD38+/DR+ of CD4)||||0.495
72425226|NCT01351025|144361749|SUPERIORITY_OR_OTHER_LEGACY|||||||0.704|TWO_SIDED|||||Two-sided p-values of \< 0.05 without adjustments for multiple testing were considered statistically significant.|Wilcoxon (Mann-Whitney)|exact Wilcoxon rank sum test was used||The null hypothesis is that there is no difference between arm A and arm B in the differences of the changes (\[week 44 - week 24\] - \[week 20 - baseline\]) in log10 D-dimer||||0.704
72425227|NCT01351025|144361750|SUPERIORITY_OR_OTHER_LEGACY|||||||0.508|TWO_SIDED|||||Two-sided p-values of \< 0.05 without adjustments for multiple testing were considered statistically significant.|Wilcoxon (Mann-Whitney)|Exact Wilcoxon rank sum test was used||The null hypothesis is that there is no difference between arm A and arm B in the differences of the changes (\[week 44 - week 24\] - \[week 20 - baseline\]) in CD8+ T-cell activation percent (% CD38+/DR+ of CD8+)||||0.508
72425228|NCT00550550|144361813|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.63|||=|0.001|TWO_SIDED|95.0|-2.6|-0.66|||ANOVA|Asthma status, treatment group, and site were fixed effects.||||-0.66|-2.60|=0.001
72425229|NCT00550550|144361814|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.2|||=|0.005|TWO_SIDED|95.0|-1.95|-0.45|||ANOVA|Asthma status, treatment group, and site were fixed effects.||||-0.45|-1.95|=0.005
72425230|NCT00550550|144361815|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.42|||=|0.066|TWO_SIDED|95.0|-0.88|0.03|||ANOVA|Asthma status, treatment group, and site were fixed effects.||||0.03|-0.88|=0.066
72425231|NCT00550550|144361816|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.32|||=|0.042|TWO_SIDED|95.0|-0.6|-0.03|||ANOVA|Asthma status, treatment group, and site were fixed effects.||||-0.03|-0.60|=0.042
72425232|NCT03757234|144361817|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment difference|-2.6|||||TWO_SIDED|95.0|-12.4|6.9|||||Point estimate and exact 95% confidence intervals for difference from levofloxacin (omadacycline minus levofloxacin) in clinical success rate was estimated.|||6.9|-12.4|
72425233|NCT03757234|144361817|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment difference|-9.9|||||TWO_SIDED|95.0|-34.8|5.3|||||Point estimate and exact 95% confidence intervals for difference from levofloxacin (omadacycline minus levofloxacin) in clinical success rate was estimated.|||5.3|-34.8|
72425234|NCT03757234|144361817|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment difference|-5.0|||||TWO_SIDED|95.0|-30.6|8.2|||||Point estimate and exact 95% confidence intervals for difference from levofloxacin (omadacycline minus levofloxacin) in clinical success rate was estimated.|||8.2|-30.6|
72334350|NCT01559259|144191648|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-43.15|||<|0.001|TWO_SIDED|95.0|-60.57|-25.72||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||9 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-25.72|-60.57|<0.001
72425235|NCT03757234|144361817|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment Difference|0.9|||||TWO_SIDED|95.0|-22.4|11.8|||||Point estimate and exact 95% confidence intervals for difference from levofloxacin (omadacycline minus levofloxacin) in clinical success rate was estimated.|||11.8|-22.4|
72334351|NCT01559259|144191648|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-44.45|||<|0.001|TWO_SIDED|95.0|-61.55|-27.34||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||9 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-27.34|-61.55|<0.001
72334352|NCT01559259|144191648|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|4.29||||0.548|TWO_SIDED|95.0|-9.8|18.38||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||9 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||18.38|-9.80|0.548
72334353|NCT01559259|144191648|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-2.51||||0.721|TWO_SIDED|95.0|-16.2|11.18||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||9 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||11.18|-16.20|0.721
72425236|NCT03757234|144361818|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment difference|-5.4|||||TWO_SIDED|95.0|-23.6|12.7|||||Point estimate and exact 95% confidence intervals for difference from levofloxacin (omadacycline minus levofloxacin) in clinical success rate was estimated.|||12.7|-23.6|
72425237|NCT03757234|144361818|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment difference|-47.7|||||TWO_SIDED|95.0|-71.3|-6.0|||||Point estimate and exact 95% confidence intervals for difference from levofloxacin (omadacycline minus levofloxacin) in clinical success rate was estimated.|||-6.0|-71.3|
72425238|NCT03757234|144361818|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment difference|-10.7|||||TWO_SIDED|95.0|-40.8|15.1|||||Point estimate and exact 95% confidence intervals for difference from levofloxacin (omadacycline minus levofloxacin) in clinical success rate was estimated.|||15.1|-40.8|
72425239|NCT03757234|144361818|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment difference|-36.5|||||TWO_SIDED|95.0|-62.6|-1.1|||||Point estimate and exact 95% confidence intervals for difference from levofloxacin (omadacycline minus levofloxacin) in clinical success rate was estimated.|||-1.1|-62.6|
72425240|NCT00697190|144361822|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin = 0.33|Mean Difference (Final Values)|-0.13|STANDARD_ERROR_OF_MEAN|0.09|||TWO_SIDED|97.5|-0.29|0.04|||Mixed Models Analysis||The mean difference is calculated as senofilcon A toric minus galyfilcon A toric.|Alternative hypothesis is that senoflicon A toric is non-inferior to galyfilcon A toric in conjunctival hyperemia.||0.04|-0.29|
72425241|NCT00697190|144361823|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin = 0.33|Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.04|||TWO_SIDED|97.5|-0.1|0.06|||Mixed Models Analysis||The mean difference is calculated as senofilcon A toric minus galyfilcon A toric.|Alternative hypothesis is that senofilcon A toric is non-inferior to galyfilcon A toric in conjunctival hyperemia.||0.06|-0.10|
72425242|NCT00697190|144361824|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin = 0.33|Mean Difference (Final Values)|-0.07|STANDARD_ERROR_OF_MEAN|0.08|||TWO_SIDED|97.5|-0.23|0.1|||Mixed Models Analysis||The mean difference is calculated as senofilcon A toric minus galyfilcon A toric.|Alternative hypothesis is that senofilcon A toric is non-inferior to galyfilcon A toric in conjunctival hyperemia.||0.10|-0.23|
72334354|NCT01559259|144191648|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|0.44||||0.951|TWO_SIDED|95.0|-13.47|14.35||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||9 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||14.35|-13.47|0.951
72425243|NCT00697190|144361825|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferior margin = 0.33|Mean Difference (Final Values)|-0.11|STANDARD_ERROR_OF_MEAN|0.08|||TWO_SIDED|97.5|-0.25|0.04|||Mixed Models Analysis||The mean difference is calculated as senofilcon A toric minus galyfilcon A toric.|Alternative hypothesis is that senofilcon A toric is non-inferior to galyfilcon A toric in limbal hyperemia.||0.04|-0.25|
72334355|NCT01559259|144191648|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-29.13||||0.005|TWO_SIDED|95.0|-46.66|-11.59||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||10 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-11.59|-46.66|0.005
72425244|NCT00697190|144361826|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferior margin = 0.33|Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.06|||TWO_SIDED|97.5|-0.16|0.07|||Mixed Models Analysis||The mean difference is calculated as senofilcon A toric minus galyfilcon A toric.|Alternative hypothesis is that senofilcon A toric is non-inferior to galyfilcon A toric in limbal hyperemia.||0.07|-0.16|
72425245|NCT00697190|144361827|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin = 0.33|Mean Difference (Final Values)|-0.06|STANDARD_ERROR_OF_MEAN|0.1|||TWO_SIDED|97.5|-0.25|0.14|||Mixed Models Analysis||The mean difference is calculated as senofilcon A toric minus galyfilcon A toric.|Alternative hypothesis is that senofilcon A toric is non-inferior to galyfilcon A toric in limbal hyperemia.||0.14|-0.25|
72425246|NCT00697190|144361828|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin = 0.33|Mean Difference (Final Values)|0.18|STANDARD_ERROR_OF_MEAN|0.07|||TWO_SIDED|97.5|0.04|0.32|||Mixed Models Analysis||The mean difference is calculated as senofilcon A toric minus galyfilcon A toric.|Alternative hypothesis is that senofilcon A toric is non-inferior to galyfilcon A toric in corneal staining.||0.32|0.04|
72425247|NCT00697190|144361829|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferior margin = 0.33|Mean Difference (Final Values)|-0.09|STANDARD_ERROR_OF_MEAN|0.08|||TWO_SIDED|97.5|-0.26|0.08|||Mixed Models Analysis||The mean difference is calculated as senofilcon A toric minus galyfilcon A toric.|Alternative hypothesis is that senofilcon A toric is non-inferior to galyfilcon A toric in corneal staining.||0.08|-0.26|
72425248|NCT00697190|144361830|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferior margin = 0.33|Median Difference (Final Values)|0.17|STANDARD_ERROR_OF_MEAN|0.08||||97.5|0.02|0.33|||Mixed Models Analysis||The mean difference is calculated as senofilcon A toric minus galyfilcon A toric.|Alternative hypothesis is that senofilcon A toric is non-inferior to galyfilcon A toric in corneal staining.||0.33|0.02|
72425249|NCT00697190|144361831|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin = 0.33|Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.13|||TWO_SIDED|97.5|-0.27|0.26|||Mixed Models Analysis||The mean difference is calculated as senofilcon A toric minus galyfilcon A toric.|Alternative hypothesis is that senofilcon A toric is non-inferior to galyfilcon A toric in conjunctival staining.||0.26|-0.27|
72425250|NCT00697190|144361832|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferior margin = 0.33|Mean Difference (Final Values)|-0.21|STANDARD_ERROR_OF_MEAN|0.07|||TWO_SIDED|97.5|-0.34|-0.08|||Mixed Models Analysis||The mean difference is calculated as senofilcon A toric minus galyfilcon A toric.|Alternative hypothesis is that senofilcon A toric is non-inferior to galyfilcon A toric in conjunctival staining.||-0.08|-0.34|
72425251|NCT00697190|144361833|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferior margin = 0.33|Mean Difference (Final Values)|-0.34|STANDARD_ERROR_OF_MEAN|0.1|||TWO_SIDED|97.5|-0.54|-0.15|||Mixed Models Analysis||The mean difference is calculated as senofilcon A toric minus galyfilcon A toric.|Alternative hypothesis is that senofilcon A toric is non-inferior to galyfilcon A toric in conjunctival staining.||-0.15|-0.54|
72425252|NCT00697190|144361834|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin = 0.33|Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.07|||TWO_SIDED|97.5|-0.12|0.14|||Mixed Models Analysis||The mean difference is calculated as senofilcon A toric minus galyfilcon A toric.|Alternative hypothesis is that senofilcon A toric is non-inferior to galyfilcon A toric in papillary conjunctivitis.||0.14|-0.12|
72425253|NCT00697190|144361835|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferior margin = 0.33|Mean Difference (Final Values)|-0.09|STANDARD_ERROR_OF_MEAN|0.07|||TWO_SIDED|97.5|-0.23|0.05|||Mixed Models Analysis||The mean difference is calculated as senofilcon A toric minus galyfilcon A toric.|Alternative hypothesis is that senofilcon A toric is non-inferior to galyfilcon A toric in papillary conjunctivitis.||0.05|-0.23|
72425254|NCT00697190|144361836|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferior margin = 0.33|Mean Difference (Final Values)|-0.09|STANDARD_ERROR_OF_MEAN|0.06|||TWO_SIDED|97.5|-0.2|0.02|||Mixed Models Analysis||The mean difference is calculated as senofilcon A toric minus galyfilcon A toric.|Alternative hypothesis is that senofilcon A toric is non-inferior to galyfilcon A toric in papillary conjunctivitis.||0.02|-0.20|
72425255|NCT02708433|144361837|SUPERIORITY||Mean Difference (Final Values)|0.0|STANDARD_DEVIATION|49.0||0.74|TWO_SIDED|95.0|-0.49|0.57|||Wilcoxon (Mann-Whitney)|||||0.57|-0.49|0.74
72425256|NCT02708433|144361838|SUPERIORITY||Mean Difference (Final Values)|0.0|STANDARD_DEVIATION|48.0||0.5|TWO_SIDED|95.0|-0.89|0.52|||Wilcoxon (Mann-Whitney)|||||0.52|-0.89|0.5
72425257|NCT02714205|144361847|SUPERIORITY||Model generated Least Square Mean|-0.54||||0.34|TWO_SIDED|95.0|-1.66|0.58|||Mixed Models Analysis|Mixed Models adjusted for baseline value, age, race, and Hispanic ethnicity. Repeated measures mixed models, with unstructured co-variance matrix|Model generated LS Mean Differences|||0.58|-1.66|0.34
72334356|NCT01559259|144191648|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-34.3||||0.001|TWO_SIDED|95.0|-51.62|-16.97||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||10 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-16.97|-51.62|0.001
72334357|NCT01559259|144191648|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-36.26|||<|0.001|TWO_SIDED|95.0|-53.8|-18.73||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||10 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-18.73|-53.80|<0.001
72425258|NCT02714205|144361848|SUPERIORITY||Model generated Least Square Mean|0.51||||0.88|TWO_SIDED|95.0|-6.15|7.18|||Mixed Models Analysis|Mixed Models adjusted for baseline value, age, race, and Hispanic ethnicity. Repeated measures mixed models, with unstructured co-variance matrix.|Model generated LS Mean Differences|||7.18|-6.15|0.88
72425259|NCT02714205|144361849|SUPERIORITY||Model generated Least Square Mean|-0.2||||0.57|TWO_SIDED|95.0|-0.88|0.48|||Mixed Models Analysis|Mixed Models adjusted for baseline value, age, race, and Hispanic ethnicity. Repeated measures mixed models, with unstructured co-variance matrix|Model generated LS Mean Differences|||0.48|-0.88|0.57
72425260|NCT02714205|144361850|SUPERIORITY||Model generated Least Square Mean Differ|-0.09||||0.81|TWO_SIDED|95.0|-0.8|0.63|||Mixed Models Analysis|Mixed Models adjusted for baseline value, age, race, and Hispanic ethnicity. Repeated measures mixed models, with unstructured co-variance matrix|Model generated LS Mean Differences|||0.63|-0.8|0.81
72425261|NCT02714205|144361851|SUPERIORITY||Model generated Least Square Mean Differ|0.43||||0.3|TWO_SIDED|95.0|-0.38|1.23|||Mixed Models Analysis|Mixed Models adjusted for baseline value, age, race, and Hispanic ethnicity. Repeated measures mixed models, with unstructured co-variance matrix|Model generated LS Mean Differences|||1.23|-0.38|0.3
72425262|NCT02714205|144361852|SUPERIORITY||Model generated Least Square Mean Differ|0.4||||0.68|TWO_SIDED|95.0|-1.52|2.32|||Mixed Models Analysis|Mixed Models adjusted for baseline value, age, race, and Hispanic ethnicity. Repeated measures mixed models, with unstructured co-variance matrix|Model generated LS Mean Differences|||2.32|-1.52|0.68
72425263|NCT02714205|144361853|SUPERIORITY||Model generated Least Square Mean Differ|-0.83||||0.12|TWO_SIDED|95.0|-1.89|0.23|||Mixed Models Analysis|Mixed Models adjusted for baseline value, age, race, and Hispanic ethnicity. Repeated measures mixed models, with unstructured co-variance matrix|Model generated LS Mean Differences|||0.23|-1.89|0.12
72334358|NCT01559259|144191648|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-34.56|||<|0.001|TWO_SIDED|95.0|-51.77|-17.35||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||10 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-17.35|-51.77|<0.001
72425264|NCT02714205|144361854|SUPERIORITY||Model generated Least Square Mean Differ|-1.41||||0.25|TWO_SIDED|95.0|-3.81|0.99|||Mixed Models Analysis|Mixed Models adjusted for baseline value, age, race, and Hispanic ethnicity. Repeated measures mixed models, with unstructured co-variance matrix|Model generated LS Mean Differences|||0.99|-3.81|0.25
72425265|NCT00381641|144361856|SUPERIORITY|"Null (historical) response rate for iodine refractory subgroup is 10%. Power=90% for 30% alternative.~Null (historical) response rate for metastatic medullary subgroup is 5%. Power=88% for 25% alternative."|||||<|0.1||||||"For iodine refractory subgroup, null hypothesis could be rejected if 6 or more responses were observed.~For metastatic medullary subgroup, null hypothesis could be rejected if 3 or more responses were observed."|Simon, two-stage design|||Note. The objective was not to compare the two arms (subgroups), but to compare each with historical data.||||<0.10
72425266|NCT01598298|144361861|OTHER|Two-sided test at the alpha=0.05 level|Coefficient for treatment term|-0.82||||0.0002|TWO_SIDED|95.0|-1.24|-0.4||Two-sided p-value; alpha=0.05|Mixed Models Analysis|Adjusted for the protocol-specified stratification factors (baseline average pain and prior taxane use)|The estimation parameter is the model-based coefficient for the treatment term, with placebo as the reference level.|The primary analysis will rely on longitudinal measures of BPI at Weeks 2, 6, and 12 for improved power. Assessment windows of +/- 7 days, +/- 14 days, and +/- 14 days will be allowed for the 2, 6, and 12 week timepoints. The analysis will be performed using mixed models, adjusted for the stratification factors.||-0.40|-1.24|0.0002
72425267|NCT01598298|144361862|OTHER|Two-sided test at the alpha=0.05 level|Coefficient for treatment term|-1.06|||<|0.0001|TWO_SIDED|95.0|-1.57|-0.55||Two-sided p-value; alpha=0.05|Mixed Models Analysis|Adjusted for baseline worst pain score and the protocol-specified stratification factors (baseline average pain and prior taxane use).|The estimation parameter is the model-based coefficient for the treatment term, with placebo as the reference level.|The primary analysis will rely on longitudinal measures of BPI at Weeks 2, 6, and 12 for improved power. Assessment windows of +/- 7 days, +/- 14 days, and +/- 14 days will be allowed for the 2, 6, and 12 week timepoints. The analysis will be performed using mixed models, adjusted for baseline worst pain score and the stratification factors.||-0.55|-1.57|<0.0001
72425268|NCT01598298|144361863|OTHER|Two-sided test at the alpha=0.05 level|Coefficient fro treatment term|-0.95|||<|0.0001|TWO_SIDED|95.0|-1.35|-0.55||Two-sided p-value; alpha=0.05|Mixed Models Analysis|Adjusted for baseline pain interference score and the protocol-specified stratification factors (baseline average pain and prior taxane use).|The estimation parameter is the model-based coefficient for the treatment term, with placebo as the reference level.|The primary analysis will rely on longitudinal measures of pain interference scores at Weeks 2, 6, and 12 for improved power. Assessment windows of +/- 7 days, +/- 14 days, and +/- 14 days will be allowed for the 2, 6, and 12 week timepoints. The analysis will be performed using mixed models, adjusted for baseline pain interference score and the stratification factors.||-0.55|-1.35|<0.0001
72425269|NCT00708721|144361898|OTHER||Maximum Tolerated Dose|1.0|||||TWO_SIDED||||||||Based on cytopenias observed at day 10 (Phase 1 trial only), and the Phase II dose was determined to be 1 mg per day for 7 consecutive days given on a 28 day cycle.|||||
72425270|NCT04105972|144361905|SUPERIORITY||Least Squares (LS) Mean Difference|15.9|||<|0.0001|TWO_SIDED|95.0|11.7|20.1|||Mixed-effects Model for Repeated Measure|||||20.1|11.7|< 0.0001
72425271|NCT04105972|144361906|SUPERIORITY||LS Mean Difference|10.2|||<|0.0001|TWO_SIDED|95.0|8.2|12.1|||Mixed-effects Model for Repeated Measure|||||12.1|8.2|<0.0001
72425272|NCT04105972|144361907|SUPERIORITY||LS Mean Difference|-42.8|||||TWO_SIDED|95.0|-46.2|-39.3||||||||-39.3|-46.2|
72425273|NCT01161472|144361917|SUPERIORITY_OR_OTHER||Least square (LS) Mean Difference|-0.0285|STANDARD_ERROR_OF_MEAN|0.018||0.1198|TWO_SIDED|95.0|-0.0647|0.0077|||ANCOVA|||Analysis of Covariance (ANCOVA) was used to determine p-value for comparison of fesoterodine 4 mg vs placebo, with model terms: period and treatment as the fixed effect, participants as the random effect, and between and within participant baselines as the covariates.||0.0077|-0.0647|0.1198
72425274|NCT01161472|144361917|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.0203|STANDARD_ERROR_OF_MEAN|0.0173||0.2459|TWO_SIDED|95.0|-0.0551|0.0145|||ANCOVA|||ANCOVA was used to determine p-value for comparison of fesoterodine 8 mg vs placebo, with model terms: period and treatment as the fixed effect, participants as the random effect, and between and within participant baselines as the covariates.||0.0145|-0.0551|0.2459
72425275|NCT01161472|144361919|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.0037|STANDARD_ERROR_OF_MEAN|0.0115||0.7502|TWO_SIDED|95.0|-0.0268|0.0194|||ANCOVA|||ANCOVA was used to determine p-value for comparison of fesoterodine 4 mg vs placebo, with model terms: period and treatment as the fixed effect, participants as the random effect, and between and within participant baselines as the covariates.||0.0194|-0.0268|0.7502
72425276|NCT01161472|144361919|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.0085|STANDARD_ERROR_OF_MEAN|0.0119||0.4785|TWO_SIDED|95.0|-0.0325|0.0154|||ANCOVA|||ANCOVA was used to determine p-value for comparison of fesoterodine 8 mg vs placebo, with model terms: period and treatment as the fixed effect, participants as the random effect, and between and within participant baselines as the covariates.||0.0154|-0.0325|0.4785
72425277|NCT01161472|144361921|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.0035|STANDARD_ERROR_OF_MEAN|0.0265||0.8944|TWO_SIDED|95.0|-0.0569|0.0498|||ANCOVA|||ANCOVA was used to determine p-value for comparison of fesoterodine 4 mg vs placebo, with model terms: period and treatment as the fixed effect, participants as the random effect, and between and within participant baselines as the covariates.||0.0498|-0.0569|0.8944
72425278|NCT01161472|144361921|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0209|STANDARD_ERROR_OF_MEAN|0.0263||0.4308|TWO_SIDED|95.0|-0.032|0.0738|||ANCOVA|||ANCOVA was used to determine p-value for comparison of fesoterodine 8 mg vs placebo, with model terms: period and treatment as the fixed effect, participants as the random effect, and between and within participant baselines as the covariates.||0.0738|-0.0320|0.4308
72425279|NCT01161472|144361923|SUPERIORITY_OR_OTHER||LS Mean Difference|3.6629|STANDARD_ERROR_OF_MEAN|12.4945||0.7707|TWO_SIDED|95.0|-21.4729|28.7987|||ANCOVA|||ANCOVA was used to determine p-value for comparison of fesoterodine 4 mg vs placebo, with model terms: period and treatment as the fixed effect, participants as the random effect, and between and within participant baselines as the covariates.||28.7987|-21.4729|0.7707
72425280|NCT01161472|144361923|SUPERIORITY_OR_OTHER||LS Mean Difference|-19.921|STANDARD_ERROR_OF_MEAN|12.4482||0.1162|TWO_SIDED|95.0|-44.9634|5.1215|||ANCOVA|||ANCOVA was used to determine p-value for comparison of fesoterodine 8 mg vs placebo, with model terms: period and treatment as the fixed effect, participants as the random effect, and between and within participant baselines as the covariates.||5.1215|-44.9634|0.1162
72425281|NCT01161472|144361925|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0068|STANDARD_ERROR_OF_MEAN|4.8707||0.9989|TWO_SIDED|95.0|-9.8297|9.8433|||ANCOVA|||ANCOVA was used to determine p-value for comparison of fesoterodine 4 mg vs placebo, with model terms: period and treatment as the fixed effect, participants as the random effect, and between and within participant baselines as the covariates.||9.8433|-9.8297|0.9989
72425282|NCT01161472|144361925|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.6251|STANDARD_ERROR_OF_MEAN|5.0346||0.7485|TWO_SIDED|95.0|-11.7926|8.5425|||ANCOVA|||ANCOVA was used to determine p-value for comparison of fesoterodine 4 mg vs placebo, with model terms: period and treatment as the fixed effect, participants as the random effect, and between and within participant baselines as the covariates.||8.5425|-11.7926|0.7485
72425283|NCT01161472|144361927|SUPERIORITY_OR_OTHER||LS Mean Difference|0.2684|STANDARD_ERROR_OF_MEAN|0.8243||0.7458|TWO_SIDED|95.0|-1.3788|1.9157|||ANCOVA|||ANCOVA was used to determine p-value for comparison of fesoterodine 4 mg vs placebo, with model terms: period and treatment as the fixed effect, participants as the random effect, and between and within participant baselines as the covariates.||1.9157|-1.3788|0.7458
72425284|NCT01161472|144361927|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.0661|STANDARD_ERROR_OF_MEAN|0.8277||0.9366|TWO_SIDED|95.0|-1.7202|1.588|||ANCOVA|||ANCOVA was used to determine p-value for comparison of fesoterodine 8 mg vs placebo, with model terms: period and treatment as the fixed effect, participants as the random effect, and between and within participant baselines as the covariates.||1.5880|-1.7202|0.9366
72425285|NCT02002884|144361972|SUPERIORITY||LS Mean difference|-0.22|||=|0.017|TWO_SIDED|95.0|-0.4|-0.04|||MMRM|||LS-Means are from mixed model with treatment group, pooled site and pre-treatment status included as fixed factors and AS at baseline, Gross Motor Function Classification System-Extended and Revised (GMFCS-E\&R) level at screening included as covariates. For MMRM visit\*treatment is interaction term repeated factor.||-0.04|-0.4|= 0.017
72425286|NCT02002884|144361972|SUPERIORITY||LS-Mean difference|-0.07|||=|0.546|TWO_SIDED|95.0|-0.29|0.15|||MMRM|||LS-Means are from mixed model with treatment group, pooled site and pre-treatment status included as fixed factors and AS at baseline, GMFCS-E\&R level at screening included as covariates. For MMRM visit\*treatment is interaction term repeated factor.||0.15|-0.29|= 0.546
72425287|NCT02002884|144361973|SUPERIORITY||LS-Mean difference|0.09|||=|0.34|TWO_SIDED|95.0|-0.1|0.28|||ANCOVA|||LS-Means are from analysis of covariance (ANCOVA) with treatment group, pooled site and pretreatment status included as fixed factors and maximum AS score of the two possible primary target patterns flexed elbow or flexed wrist baseline, GMFCS-E\&R level at screening included as covariates.||0.28|-0.1|= 0.34
72425288|NCT02002884|144361973|SUPERIORITY||LS-Mean difference|-0.12|||=|0.297|TWO_SIDED|95.0|-0.36|0.11|||ANCOVA|||LS-Means are from ANCOVA with treatment group, pooled site and pre-treatment status included as fixed factors and maximum AS score of the two possible primary target patterns flexed elbow or flexed wrist baseline, GMFCS-E\&R level at screening included as covariates.||0.11|-0.36|= 0.297
72425289|NCT02966002|144361987|OTHER|||||||0.96|||||||t-test, 2 sided|||||||0.96
72425290|NCT02966002|144361988|OTHER|||||||0.67|||||||t-test, 2 sided|||||||0.67
72425291|NCT02966002|144361989|OTHER|||||||0.18|||||||t-test, 2 sided|||||||0.18
72425292|NCT02966002|144361990|OTHER|||||||0.25|||||||t-test, 2 sided|||||||0.25
72425293|NCT03377790|144361991|SUPERIORITY||||||<|0.0001||||||Differences between treatments arms are compared using a chi-square test.|Chi-squared|||||||<0.0001
72425294|NCT03377790|144361992|SUPERIORITY|||||||0.0067|||||||Chi-squared|Differences between treatments arms are compared using a chi-square test.||||||0.0067
72425295|NCT03377790|144361993|SUPERIORITY|||||||0.0152|||||||Chi-squared|Differences between treatments arms are compared using a chi-square test.||||||0.0152
72425296|NCT03377790|144361994|SUPERIORITY|||||||0.0302|||||||Chi-squared|Differences between treatments arms are compared using a chi-square test.||||||0.0302
72425297|NCT03377790|144361995|SUPERIORITY|||||||0.5921|||||||ANCOVA|Differences between Tx arms are compared using an ANCOVA with treatment as the independent factor and baseline CDLQI composite score as the covariate.||||||0.5921
72425298|NCT03377790|144361996|SUPERIORITY||||||<|0.0001|||||||ANCOVA|Differences between treatment arms are compared using an ANCOVA, with treatment as the independent factor and baseline lesion count as the covariate.||||||<0.0001
72425299|NCT03377790|144361997|SUPERIORITY||||||<|0.0001|||||||ANCOVA|Differences between treatment arms are compared using an ANCOVA, with treatment as the independent factor and baseline lesion count as the covariate.||||||<0.0001
72425300|NCT03377790|144361998|SUPERIORITY||||||<|0.0001|||||||Chi-squared|Differences between treatments arms are compared using a chi-square test.||||||<0.0001
72425301|NCT03377790|144361999|SUPERIORITY||||||<|0.0001|||||||Chi-squared|Differences between treatments arms are compared using a chi-square test.||||||<0.0001
72425302|NCT03377790|144362000|SUPERIORITY|||||||0.052|||||||Chi-squared|Differences between treatments arms are compared using a chi-square test.||||||0.0520
72425303|NCT02632786|144362001|SUPERIORITY||Risk Ratio (RR)|0.82||||0.319|TWO_SIDED|95.0|0.55|1.21|||Cochran-Mantel-Haenszel|||||1.21|0.55|0.3190
72425304|NCT02632786|144362002|SUPERIORITY||Mean Difference (Net)|-0.78||||0.5563|TWO_SIDED|95.0|-3.37|1.81|||Mixed Models Analysis|||||1.81|-3.37|0.5563
72425305|NCT02632786|144362003|SUPERIORITY||Mean Difference (Net)|5.0||||0.8992|TWO_SIDED|95.0|-11.5|23.0|||ANCOVA|||||23.00|-11.50|0.8992
72425306|NCT02632786|144362004|SUPERIORITY||Risk Ratio (RR)|1.54||||0.3529|TWO_SIDED|95.0|0.6|3.94|||Cochran-Mantel-Haenszel|||||3.94|0.60|0.3529
72425307|NCT02632786|144362005|SUPERIORITY||Mean Difference (Net)|-0.6||||0.757|TWO_SIDED|95.0|-4.2|3.0|||Mixed Models Analysis|||||3.0|-4.2|0.7570
72425308|NCT02632786|144362006|SUPERIORITY||Slope|-71.97||||0.0729|TWO_SIDED|95.0|-150.72|6.79|||Mixed Models Analysis|||||6.79|-150.72|0.0729
72425309|NCT02632786|144362007|SUPERIORITY|||||||0.4142|||||||Cochran-Mantel-Haenszel|||||||0.4142
72425310|NCT00569803|144362038|SUPERIORITY_OR_OTHER||Ratio of Geometric Means|0.86|||||TWO_SIDED|90.0|0.68|1.08|||||Ratio of Geometric Means: 50mg SC over 125mg IV|||1.08|0.68|
72425311|NCT00569803|144362038|SUPERIORITY_OR_OTHER||Ratio of Geometric Means|0.61|||||TWO_SIDED|90.0|0.48|0.77|||||Ratio of Geometric Means: 100mg SC over 125mg IV|||0.77|0.48|
72425312|NCT00569803|144362038|SUPERIORITY_OR_OTHER||Ratio of Geometric Means|0.78|||||TWO_SIDED|90.0|0.62|0.99|||||Ratio of Geometric Means: 125mg SC over 125mg IV|||0.99|0.62|
72425313|NCT00569803|144362038|SUPERIORITY_OR_OTHER||Ratio of Geometric Means|0.89|||||TWO_SIDED|90.0|0.71|1.13|||||Ratio of Geometric Means: 150mg SC over 125mg IV|||1.13|0.71|
72425314|NCT00569803|144362038|SUPERIORITY_OR_OTHER||Ratio of Geometric Means|0.88|||||TWO_SIDED|90.0|0.69|1.11|||||Ratio of Geometric Means: 200mg SC over 125mg IV|||1.11|0.69|
72425315|NCT00569803|144362038|SUPERIORITY_OR_OTHER||Ratio of Geometric Means|0.73|||||TWO_SIDED|90.0|0.57|0.92|||||Ratio of Geometric Means: 250mg SC over 125mg IV|||0.92|0.57|
72425316|NCT00569803|144362039|SUPERIORITY_OR_OTHER||Ratio of Geometric Means|0.87|||||TWO_SIDED|90.0|0.69|1.1|||||Ratio of Geometric Means: 50mg SC over 125mg IV|||1.10|0.69|
72425317|NCT00569803|144362039|SUPERIORITY_OR_OTHER||Ratio of Geometric Means|0.61|||||TWO_SIDED|90.0|0.48|0.77|||||Ratio of Geometric Means: 100mg SC over 125mg IV|||0.77|0.48|
72425318|NCT00569803|144362039|SUPERIORITY_OR_OTHER||Ratio of Geometric Means|0.79|||||TWO_SIDED|90.0|0.62|1.0|||||Ratio of Geometric Means: 125mg SC over 125mg IV|||1.00|0.62|
72425319|NCT00569803|144362039|SUPERIORITY_OR_OTHER||Ratio of Geometric Means|0.9|||||TWO_SIDED|90.0|0.71|1.14|||||Ratio of Geometric Means: 150mg SC over 125mg IV|||1.14|0.71|
72425320|NCT00569803|144362039|SUPERIORITY_OR_OTHER||Ratio of Geometric Means|0.88|||||TWO_SIDED|90.0|0.69|1.12|||||Ratio of Geometric Means: 200mg SC over 125mg IV|||1.12|0.69|
72425321|NCT00569803|144362039|SUPERIORITY_OR_OTHER||Ratio of Geometric Means|0.73|||||TWO_SIDED|90.0|0.57|0.92|||||Ratio of Geometric Means: 250mg SC over 125mg IV|||0.92|0.57|
72425322|NCT00569803|144362045|SUPERIORITY_OR_OTHER||Ratio of Geometric Means|0.9|||||TWO_SIDED|90.0|0.75|1.07|||||AUC(0-T) Ratio of Geometric Means: 1 injection site over 2 injection sites|||1.07|0.75|
72425323|NCT00569803|144362045|SUPERIORITY_OR_OTHER||Ratio of Geometric Means|0.9|||||TWO_SIDED|90.0|0.75|1.07|||||AUC(INF) Ratio of Geometric Means: 1 injection site over 2 injection sites|||1.07|0.75|
72425324|NCT00791921|144362068|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Regression, Logistic|||For ACR20 responder rate at Week 12, comparison between the CDP870 200 mg group and the placebo group was performed.||||<0.05
72425325|NCT00791921|144362069|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Regression, Logistic|||||||<0.05
72425326|NCT00474175|144362070|SUPERIORITY_OR_OTHER||Treatment difference|16.46|||<|0.001|TWO_SIDED|95.0|7.2|25.7||Alternative hypotheses tested in the study was that benzocaine 20% was significantly (p less than or equal to \[=\<\] 0.05) more effective than placebo.|Cochran-Mantel-Haenszel|||P-value was calculated using Cochran-Mantel-Haenszel (CMH) test which was adjusted for site and baseline DPS. Treatment difference (Benzocaine 20% - Placebo) and its associated confidence interval (C.I.) was calculated based on CMH weighted percentages and the corresponding standard error.||25.7|7.2|<0.001
72425327|NCT00474175|144362070|SUPERIORITY_OR_OTHER||Treatment difference|9.8||||0.038|TWO_SIDED|95.0|0.3|19.3||Alternative hypotheses tested in the study was that benzocaine 10% was significantly (p=\<0.05) more effective than placebo provided that benzocaine 20% was more effective than placebo.|Cochran-Mantel-Haenszel|||P-value was calculated using CMH test which was adjusted for site and baseline DPS. Treatment difference (Benzocaine 10% - Placebo) and its associated C.I. was calculated based on CMH weighted percentages and the corresponding standard error.||19.3|0.3|0.038
72425328|NCT00474175|144362070|SUPERIORITY_OR_OTHER||Treatment difference|6.72||||0.047|TWO_SIDED|95.0|0.2|13.3|||Cochran-Mantel-Haenszel|Dose response was considered established if the percentage of responders between the 20% and 10% was greater than or equal to 5%.||P-value was calculated using CMH test which was adjusted for site and baseline DPS. Treatment difference (Benzocaine 20% - Benzocaine 10%) and its associated C.I. was calculated based on CMH weighted percentages and the corresponding standard error.||13.3|0.2|0.047
72425329|NCT00474175|144362071|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.02|||<|0.001|TWO_SIDED|95.0|1.55|2.64||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|Regression, Cox|||P-value was calculated using Cox proportional hazard regression model which was adjusted for treatment, site and baseline DPS. Hazard Ratio (HR) of Benzocaine 20% relative to the Placebo was calculated. C.I. was based on the Wald statistic.||2.64|1.55|<0.001
72425330|NCT00474175|144362071|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.63|||<|0.001|TWO_SIDED|95.0|1.26|2.12||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|Regression, Cox|||P-value was calculated using Cox proportional hazard regression model which was adjusted for treatment, site and baseline DPS. HR of Benzocaine 10% relative to the Placebo was calculated. C.I. was based on the Wald statistic.||2.12|1.26|<0.001
72334359|NCT01559259|144191648|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|5.45||||0.455|TWO_SIDED|95.0|-8.89|19.79||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||10 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||19.79|-8.89|0.455
72334360|NCT01559259|144191648|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|0.43||||0.953|TWO_SIDED|95.0|-13.8|14.65||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||10 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||14.65|-13.80|0.953
72425331|NCT00474175|144362071|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.24||||0.03|TWO_SIDED|95.0|1.02|1.51||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|Regression, Cox|||P-value was calculated using Cox proportional hazard regression model which was adjusted for treatment, site and baseline DPS. HR of Benzocaine 20% relative to the Benzocaine 10% was calculated. C.I. was based on the Wald statistic.||1.51|1.02|0.030
72425332|NCT00474175|144362072|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.04|||<|0.001|TWO_SIDED|95.0|1.57|2.66||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|Regression, Cox|||P-value was calculated using Cox proportional hazard regression model which was adjusted for treatment, site and baseline DPS. HR of Benzocaine 20% relative to the Placebo was calculated. C.I. was based on the Wald statistic.||2.66|1.57|<0.001
72425333|NCT00474175|144362072|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.73|||<|0.001|TWO_SIDED|95.0|1.34|2.25||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|Regression, Cox|||P-value was calculated using Cox proportional hazard regression model which was adjusted for treatment, site and baseline DPS. HR of Benzocaine 10% relative to the Placebo was calculated. C.I. was based on the Wald statistic.||2.25|1.34|<0.001
72425334|NCT00474175|144362072|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.18||||0.1|TWO_SIDED|95.0|0.97|1.43||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|Regression, Cox|||P-value was calculated using Cox proportional hazard regression model which was adjusted for treatment, site and baseline DPS. HR of Benzocaine 20% relative to the Benzocaine 10% was calculated. C.I. was based on the Wald statistic.||1.43|0.97|0.100
72425335|NCT00474175|144362074|SUPERIORITY_OR_OTHER||Treatment difference|0.49||||0.035|TWO_SIDED|95.0|0.03|0.95||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||SPRID 60: P-value was calculated using Analysis of Variance (ANOVA) which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 20% - Placebo) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.||0.95|0.03|0.035
72425336|NCT00474175|144362074|SUPERIORITY_OR_OTHER||Treatment difference|0.32||||0.173|TWO_SIDED|95.0|-0.14|0.78||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||SPRID 60: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 10% - Placebo) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.||0.78|-0.14|0.173
72425337|NCT00474175|144362074|SUPERIORITY_OR_OTHER||Treatment difference|0.18||||0.358|TWO_SIDED|95.0|-0.2|0.55||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||SPRID 60: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 20% - Benzocaine 10%) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.||0.55|-0.20|0.358
72425338|NCT00474175|144362074|SUPERIORITY_OR_OTHER||Treatment difference|0.75||||0.135|TWO_SIDED|95.0|-0.23|1.72||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||SPRID 120: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 20% - Placebo) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.||1.72|-0.23|0.135
72425339|NCT00474175|144362074|SUPERIORITY_OR_OTHER||Treatment difference|0.48||||0.332|TWO_SIDED|95.0|-0.49|1.46||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||SPRID 120: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 10% - Placebo) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.||1.46|-0.49|0.332
72425340|NCT00474175|144362074|SUPERIORITY_OR_OTHER||Treatment difference|0.26||||0.517|TWO_SIDED|95.0|-0.53|1.06||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||SPRID 120: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 20% - Benzocaine 10%) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.||1.06|-0.53|0.517
72425341|NCT00474175|144362076|SUPERIORITY_OR_OTHER||Treatment difference|0.93|||<|0.001|TWO_SIDED|95.0|0.5|1.35||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||5 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 20% - Placebo) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.||1.35|0.50|<0.001
72425342|NCT00474175|144362076|SUPERIORITY_OR_OTHER||Treatment difference|0.55||||0.011|TWO_SIDED|95.0|0.13|0.97||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||5 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 10% - Placebo) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.||0.97|0.13|0.011
72334361|NCT01559259|144191648|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-2.48||||0.731|TWO_SIDED|95.0|-16.63|11.66||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||10 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||11.66|-16.63|0.731
72334362|NCT01559259|144191648|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-22.63||||0.024|TWO_SIDED|95.0|-39.97|-5.29||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||11 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-5.29|-39.97|0.024
72425343|NCT00474175|144362076|SUPERIORITY_OR_OTHER||Treatment difference|0.38||||0.031|TWO_SIDED|95.0|0.03|0.72||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||5 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 20% - Benzocaine 10%) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.||0.72|0.03|0.031
72425344|NCT00474175|144362076|SUPERIORITY_OR_OTHER||Treatment difference|0.78|||<|0.001|TWO_SIDED|95.0|0.33|1.23||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||10 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 20% - Placebo) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.||1.23|0.33|<0.001
72425345|NCT00474175|144362076|SUPERIORITY_OR_OTHER||Treatment difference|0.49||||0.031|TWO_SIDED|95.0|0.04|0.94||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||10 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 10% - Placebo) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.||0.94|0.04|0.031
72425346|NCT00474175|144362076|SUPERIORITY_OR_OTHER||Treatment difference|0.29||||0.119|TWO_SIDED|95.0|-0.07|0.66||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||10 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 20% - Benzocaine 10%) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.||0.66|-0.07|0.119
72334363|NCT01559259|144191648|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-26.87||||0.009|TWO_SIDED|95.0|-44.12|-9.62||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||11 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-9.62|-44.12|0.009
72425347|NCT00474175|144362076|SUPERIORITY_OR_OTHER||Treatment difference|0.77||||0.002|TWO_SIDED|95.0|0.28|1.25||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||15 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 20% - Placebo) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.||1.25|0.28|0.002
72425348|NCT00474175|144362076|SUPERIORITY_OR_OTHER||Treatment difference|0.46||||0.061|TWO_SIDED|95.0|-0.02|0.95||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||15 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 10% - Placebo) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.||0.95|-0.02|0.061
72425349|NCT00474175|144362076|SUPERIORITY_OR_OTHER||Treatment difference|0.3||||0.131|TWO_SIDED|95.0|-0.09|0.7||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||15 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 20% - Benzocaine 10%) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.||0.70|-0.09|0.131
72425350|NCT00474175|144362076|SUPERIORITY_OR_OTHER||Treatment difference|0.52||||0.044|TWO_SIDED|95.0|0.01|1.03||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||20 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 20% - Placebo) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.||1.03|0.01|0.044
72425351|NCT00474175|144362076|SUPERIORITY_OR_OTHER||Treatment difference|0.43||||0.099|TWO_SIDED|95.0|-0.08|0.93||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||20 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 10% - Placebo) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.||0.93|-0.08|0.099
72334364|NCT01559259|144191648|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-30.76||||0.003|TWO_SIDED|95.0|-48.36|-13.16||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||11 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-13.16|-48.36|0.003
72334365|NCT01559259|144191648|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-27.26||||0.007|TWO_SIDED|95.0|-44.51|-10.0||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||11 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-10.00|-44.51|0.007
72334366|NCT01559259|144191648|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|4.66||||0.516|TWO_SIDED|95.0|-9.5|18.82||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||11 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||18.82|-9.50|0.516
72334367|NCT01559259|144191648|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|0.55||||0.939|TWO_SIDED|95.0|-13.63|14.72||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||11 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||14.72|-13.63|0.939
72334368|NCT01559259|144191648|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-4.53||||0.536|TWO_SIDED|95.0|-18.86|9.8||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||11 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||9.80|-18.86|0.536
72425352|NCT00474175|144362076|SUPERIORITY_OR_OTHER||Treatment difference|0.1||||0.647|TWO_SIDED|95.0|-0.32|0.51||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||20 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 20% - Benzocaine 10%) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.||0.51|-0.32|0.647
72425353|NCT00474175|144362076|SUPERIORITY_OR_OTHER||Treatment difference|0.6||||0.023|TWO_SIDED|95.0|0.08|1.11||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||25 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 20% - Placebo) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.||1.11|0.08|0.023
72334369|NCT01559259|144191648|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-15.81||||0.107|TWO_SIDED|95.0|-33.02|1.41||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||12 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||1.41|-33.02|0.107
72425354|NCT00474175|144362076|SUPERIORITY_OR_OTHER||Treatment difference|0.47||||0.072|TWO_SIDED|95.0|-0.04|0.98||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||25 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 10% - Placebo) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.||0.98|-0.04|0.072
72334370|NCT01559259|144191648|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-23.71||||0.019|TWO_SIDED|95.0|-40.91|-6.51||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||12 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-6.51|-40.91|0.019
72425355|NCT00474175|144362076|SUPERIORITY_OR_OTHER||Treatment difference|0.13||||0.551|TWO_SIDED|95.0|-0.29|0.55||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||25 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 20% - Benzocaine 10%) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.||0.55|-0.29|0.551
72425356|NCT00474175|144362076|SUPERIORITY_OR_OTHER||Treatment difference|0.54||||0.047|TWO_SIDED|95.0|0.01|1.08||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||30 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 20% - Placebo) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.||1.08|0.01|0.047
72425357|NCT00474175|144362076|SUPERIORITY_OR_OTHER||Treatment difference|0.27||||0.316|TWO_SIDED|95.0|-0.26|0.81||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||30 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 10% - Placebo) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.||0.81|-0.26|0.316
72425358|NCT00474175|144362076|SUPERIORITY_OR_OTHER||Treatment difference|0.27||||0.224|TWO_SIDED|95.0|-0.17|0.71||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||30 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 20% - Benzocaine 10%) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.||0.71|-0.17|0.224
72425359|NCT00474175|144362076|SUPERIORITY_OR_OTHER||Treatment difference|0.46||||0.099|TWO_SIDED|95.0|-0.09|1.01||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||40 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 20% - Placebo) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.||1.01|-0.09|0.099
72425360|NCT00474175|144362076|SUPERIORITY_OR_OTHER||Treatment difference|0.37||||0.186|TWO_SIDED|95.0|-0.18|0.92||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||40 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 10% - Placebo) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.||0.92|-0.18|0.186
72425361|NCT00474175|144362076|SUPERIORITY_OR_OTHER||Treatment difference|0.09||||0.684|TWO_SIDED|95.0|-0.35|0.54||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||40 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 20% - Benzocaine 10%) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.||0.54|-0.35|0.684
72425362|NCT00474175|144362076|SUPERIORITY_OR_OTHER||Treatment difference|0.21||||0.452|TWO_SIDED|95.0|-0.34|0.76||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||50 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 20% - Placebo) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.||0.76|-0.34|0.452
72425363|NCT00474175|144362076|SUPERIORITY_OR_OTHER||Treatment difference|0.2||||0.479|TWO_SIDED|95.0|-0.35|0.75||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||50 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 10% - Placebo) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.||0.75|-0.35|0.479
72425364|NCT00474175|144362076|SUPERIORITY_OR_OTHER||Treatment difference|0.01||||0.955|TWO_SIDED|95.0|-0.44|0.46||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||50 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 20% - Benzocaine 10%) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.||0.46|-0.44|0.955
72425365|NCT00474175|144362076|SUPERIORITY_OR_OTHER||Treatment difference|0.21||||0.465|TWO_SIDED|95.0|-0.36|0.79||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||60 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 20% - Placebo) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.||0.79|-0.36|0.465
72425366|NCT00474175|144362076|SUPERIORITY_OR_OTHER||Treatment difference|0.0||||0.992|TWO_SIDED|95.0|-0.57|0.58||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||60 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 10% - Placebo) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.||0.58|-0.57|0.992
72425367|NCT00474175|144362076|SUPERIORITY_OR_OTHER||Treatment difference|0.21||||0.376|TWO_SIDED|95.0|-0.26|0.68||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||60 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 20% - Benzocaine 10%) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.||0.68|-0.26|0.376
72425368|NCT00474175|144362076|SUPERIORITY_OR_OTHER||Treatment difference|0.36||||0.229|TWO_SIDED|95.0|-0.22|0.93||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||70 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 20% - Placebo) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.||0.93|-0.22|0.229
72425369|NCT00474175|144362076|SUPERIORITY_OR_OTHER||Treatment difference|0.16||||0.581|TWO_SIDED|95.0|-0.41|0.74||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||70 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 10% - Placebo) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.||0.74|-0.41|0.581
72425370|NCT00474175|144362076|SUPERIORITY_OR_OTHER||Treatment difference|0.19||||0.422|TWO_SIDED|95.0|-0.28|0.66||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||70 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 20% - Benzocaine 10%) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.||0.66|-0.28|0.422
72425371|NCT00474175|144362076|SUPERIORITY_OR_OTHER||Treatment difference|0.33||||0.271|TWO_SIDED|95.0|-0.26|0.91||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||80 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 20% - Placebo) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.||0.91|-0.26|0.271
72425372|NCT00474175|144362076|SUPERIORITY_OR_OTHER||Treatment difference|0.15||||0.612|TWO_SIDED|95.0|-0.43|0.73||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||80 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 10% - Placebo) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.||0.73|-0.43|0.612
72425373|NCT00474175|144362076|SUPERIORITY_OR_OTHER||Treatment difference|0.18||||0.465|TWO_SIDED|95.0|-0.3|0.65||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||80 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 20% - Benzocaine 10%) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.||0.65|-0.30|0.465
72425374|NCT00474175|144362076|SUPERIORITY_OR_OTHER||Treatment difference|0.32||||0.29|TWO_SIDED|95.0|-0.27|0.91||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||90 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 20% - Placebo) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.||0.91|-0.27|0.290
72425375|NCT00474175|144362076|SUPERIORITY_OR_OTHER||Treatment difference|0.25||||0.412|TWO_SIDED|95.0|-0.34|0.83||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||90 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 10% - Placebo) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.||0.83|-0.34|0.412
72334371|NCT01559259|144191648|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-28.44||||0.006|TWO_SIDED|95.0|-45.99|-10.88||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||12 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-10.88|-45.99|0.006
72334372|NCT01559259|144191648|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-25.04||||0.012|TWO_SIDED|95.0|-42.23|-7.85||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||12 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-7.85|-42.23|0.012
72334373|NCT01559259|144191648|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|9.16||||0.195|TWO_SIDED|95.0|-4.75|23.08||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||12 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||23.08|-4.75|0.195
72334374|NCT01559259|144191648|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|1.48||||0.835|TWO_SIDED|95.0|-12.54|15.5||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||12 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||15.50|-12.54|0.835
72425376|NCT00474175|144362076|SUPERIORITY_OR_OTHER||Treatment difference|0.07||||0.769|TWO_SIDED|95.0|-0.41|0.55||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||90 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 20% - Benzocaine 10%) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.||0.55|-0.41|0.769
72425377|NCT00474175|144362076|SUPERIORITY_OR_OTHER||Treatment difference|0.15||||0.61|TWO_SIDED|95.0|-0.43|0.74||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||100 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 20% - Placebo) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.||0.74|-0.43|0.610
72425378|NCT00474175|144362076|SUPERIORITY_OR_OTHER||Treatment difference|0.2||||0.511|TWO_SIDED|95.0|-0.39|0.78||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||100 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 10% - Placebo) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.||0.78|-0.39|0.511
72425379|NCT00474175|144362076|SUPERIORITY_OR_OTHER||Treatment difference|-0.04||||0.859|TWO_SIDED|95.0|-0.52|0.43||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||100 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 20% - Benzocaine 10%) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.||0.43|-0.52|0.859
72425380|NCT00474175|144362076|SUPERIORITY_OR_OTHER||Treatment difference|0.26||||0.386|TWO_SIDED|95.0|-0.33|0.84||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||110 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 20% - Placebo) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.||0.84|-0.33|0.386
72425381|NCT00474175|144362076|SUPERIORITY_OR_OTHER||Treatment difference|0.17||||0.563|TWO_SIDED|95.0|-0.41|0.76||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||110 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 10% - Placebo) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.||0.76|-0.41|0.563
72425382|NCT00474175|144362076|SUPERIORITY_OR_OTHER||Treatment difference|0.09||||0.721|TWO_SIDED|95.0|-0.39|0.56||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||110 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 20% - Benzocaine 10%) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.||0.56|-0.39|0.721
72425383|NCT00474175|144362076|SUPERIORITY_OR_OTHER||Treatment difference|0.1||||0.725|TWO_SIDED|95.0|-0.48|0.69||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||120 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 20% - Placebo) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.||0.69|-0.48|0.725
72425384|NCT00474175|144362076|SUPERIORITY_OR_OTHER||Treatment difference|0.06||||0.839|TWO_SIDED|95.0|-0.52|0.64||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||120 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 10% - Placebo) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.||0.64|-0.52|0.839
72425385|NCT00474175|144362076|SUPERIORITY_OR_OTHER||Treatment difference|0.04||||0.855|TWO_SIDED|95.0|-0.43|0.52||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||120 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 20% - Benzocaine 10%) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.||0.52|-0.43|0.855
72425386|NCT00474175|144362077|SUPERIORITY_OR_OTHER||Treatment difference|0.17||||0.035|TWO_SIDED|95.0|0.01|0.33||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|Cochran-Mantel-Haenszel|||P-value was calculated from the CMH test with modified ridit scores, adjusted for site baseline pain intensity. Treatment difference (Benzocaine 20% versus Placebo) and the associated confidence interval were calculated based on the weighted Gamma statistic.||0.33|0.01|0.035
72425387|NCT00474175|144362077|SUPERIORITY_OR_OTHER||Treatment difference|0.16||||0.039|TWO_SIDED|95.0|0.0|0.33||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|Cochran-Mantel-Haenszel|||P-value was calculated from the CMH test with modified ridit scores, adjusted for site baseline pain intensity. Treatment difference (Benzocaine 10% versus Placebo) and the associated confidence interval were calculated based on the weighted Gamma statistic.||0.33|-0.00|0.039
72334375|NCT01559259|144191648|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-4.41||||0.542|TWO_SIDED|95.0|-18.61|9.79||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||12 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||9.79|-18.61|0.542
72334376|NCT01559259|144191649|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.9|||<|0.001|TWO_SIDED|95.0|0.79|1.01||p-value was calculated using CMH test with modified ridit scores, controlling for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||Treatment difference and its associated 95% CI were calculated based on the weighted Gamma statistic.||1.01|0.79|<0.001
72334377|NCT01559259|144191649|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.83|||<|0.001|TWO_SIDED|95.0|0.79|1.01||p-value was calculated using CMH test with modified ridit scores, controlling for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||Treatment difference and its associated 95% CI were calculated based on the weighted Gamma statistic.||1.01|0.79|< 0.001
72334378|NCT01559259|144191649|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.86|||<|0.001|TWO_SIDED|95.0|0.73|0.99||p-value was calculated using CMH test with modified ridit scores, controlling for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||Treatment difference and its associated 95% CI were calculated based on the weighted Gamma statistic.||0.99|0.73|< 0.001
72334379|NCT01559259|144191649|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.8|||<|0.001|TWO_SIDED|95.0|0.65|0.95||p-value was calculated using CMH test with modified ridit scores, controlling for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||Treatment difference and its associated 95% CI were calculated based on the weighted Gamma statistic.||0.95|0.65|< 0.001
72334380|NCT01559259|144191649|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.15||||0.174|TWO_SIDED|95.0|-0.07|0.37||p-value was calculated using CMH test with modified ridit scores, controlling for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||Treatment difference and its associated 95% CI were calculated based on the weighted Gamma statistic.||0.37|-0.07|0.174
72334381|NCT01559259|144191649|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.04||||0.722|TWO_SIDED|95.0|-0.18|0.26||p-value was calculated using CMH test with modified ridit scores, controlling for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||Treatment difference and its associated 95% CI were calculated based on the weighted Gamma statistic.||0.26|-0.18|0.722
72334382|NCT01559259|144191649|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.1||||0.365|TWO_SIDED|95.0|-0.32|0.11||p-value was calculated using CMH test with modified ridit scores, controlling for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||Treatment difference and its associated 95% CI were calculated based on the weighted Gamma statistic.||0.11|-0.32|0.365
72334383|NCT00218634|144191657|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||HLM|||We used HLM with weekly visit data for the acute outcome. There were, therefore, 11 time points used.||||<.05
72334384|NCT00218634|144191658|SUPERIORITY_OR_OTHER||||||<|0.05||95.0||||GLM - CBT-AD would be superior to ETAU at post. HLM - CBT-AD would be superior to CBT-AD at follow ups.|GLM and HLM|||||||<.05
72334385|NCT00218634|144191660|SUPERIORITY_OR_OTHER||||||<|0.05||95.0||||CD4 would be more improved in the treatment condition|HLM|||follow up analysis revealed that CD4, over time, significantly improved over control when covarying out baseline levels.||||<.05
72334386|NCT01159171|144191672|SUPERIORITY_OR_OTHER|||||||0.0047||0.0||||One-sided p-value|One sample exact binomial test|||||||0.0047
72334387|NCT01461928|144191684|SUPERIORITY||Hazard Ratio (HR)|0.76|||=|0.41|TWO_SIDED|95.0|0.37|1.53||Power at time of final analysis was less than 40%. Final analysis was not able to address its primary objective.|Stratified Long-rank|||The stratified log rank test p-value was derived using the following randomization stratification strata : Follicular Lymphoma International Prognostic Index (FLIPI) risk category (low, intermediate, high) and indolent NHL subtype (follicular lymphoma, non-follicular lymphoma). Power at time of final analysis was less than 40%. Final analysis was not able to address it's primary objective.||1.53|0.37|= 0.410
72334388|NCT01018134|144191701|SUPERIORITY_OR_OTHER|||||||0.4261|||||||t-test, 1 sided|||||||0.4261
72334389|NCT01018134|144191701|SUPERIORITY_OR_OTHER|||||||0.4219|||||||t-test, 1 sided|||||||0.4219
72334390|NCT01018134|144191701|SUPERIORITY_OR_OTHER|||||||0.1826|||||||t-test, 1 sided|||||||0.1826
72334391|NCT01018134|144191701|SUPERIORITY_OR_OTHER|||||||0.009||||||Statistically significant difference between treatment groups|t-test, 1 sided|||||||0.0090
72334392|NCT01018134|144191701|SUPERIORITY_OR_OTHER|||||||0.3421|||||||t-test, 1 sided|||||||0.3421
72334393|NCT01018134|144191701|SUPERIORITY_OR_OTHER|||||||0.01||||||Statistically significant difference between treatment groups|t-test, 1 sided|||||||0.0100
72334394|NCT01018134|144191701|SUPERIORITY_OR_OTHER|||||||0.2103|||||||t-test, 1 sided|||||||0.2103
72334395|NCT01018134|144191701|SUPERIORITY_OR_OTHER|||||||0.12|||||||t-test, 1 sided|||||||0.1200
72334396|NCT01018134|144191702|SUPERIORITY_OR_OTHER|||||||0.2631|||||||t-test, 1 sided|||||||0.2631
72425388|NCT00474175|144362077|SUPERIORITY_OR_OTHER||Treatment difference|-0.01||||0.944|TWO_SIDED|95.0|-0.15|0.13||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|Cochran-Mantel-Haenszel|||P-value was calculated from the CMH test with modified ridit scores, adjusted for site baseline pain intensity. Treatment difference (Benzocaine 20% versus Benzocaine 10%) and the associated confidence interval were calculated based on the weighted Gamma statistic.||0.13|-0.15|0.944
72334397|NCT01018134|144191702|SUPERIORITY_OR_OTHER|||||||0.2968|||||||t-test, 1 sided|||||||0.2968
72334398|NCT01018134|144191702|SUPERIORITY_OR_OTHER|||||||0.0186||||||statistically significant difference between treatment groups|t-test, 1 sided|||||||0.0186
72334399|NCT01018134|144191702|SUPERIORITY_OR_OTHER|||||||0.0361||||||statistically significant difference between treatment groups|t-test, 1 sided|||||||0.0361
72334400|NCT01018134|144191702|SUPERIORITY_OR_OTHER|||||||0.007||||||statistically significant difference between treatment groups|t-test, 1 sided|||||||0.0070
72334401|NCT01018134|144191702|SUPERIORITY_OR_OTHER|||||||0.1583|||||||t-test, 1 sided|||||||0.1583
72334402|NCT01018134|144191702|SUPERIORITY_OR_OTHER|||||||0.2078|||||||t-test, 1 sided|||||||0.2078
72334403|NCT01018134|144191702|SUPERIORITY_OR_OTHER|||||||0.2878|||||||t-test, 1 sided|||||||0.2878
72334404|NCT01018134|144191703|SUPERIORITY_OR_OTHER|||||||0.2713|||||||Wilcoxon (Mann-Whitney)|||||||0.2713
72334405|NCT01018134|144191703|SUPERIORITY_OR_OTHER|||||||0.2689|||||||Wilcoxon (Mann-Whitney)|||||||0.2689
72334406|NCT01018134|144191703|SUPERIORITY_OR_OTHER|||||||0.0419|||||||Wilcoxon (Mann-Whitney)|||||||0.0419
72334407|NCT01018134|144191703|SUPERIORITY_OR_OTHER|||||||0.0309|||||||Wilcoxon (Mann-Whitney)|||||||0.0309
72334408|NCT01018134|144191703|SUPERIORITY_OR_OTHER|||||||0.1126|||||||Wilcoxon (Mann-Whitney)|||||||0.1126
72334409|NCT01018134|144191703|SUPERIORITY_OR_OTHER|||||||0.0033|||||||Wilcoxon (Mann-Whitney)|||||||0.0033
72334410|NCT01018134|144191703|SUPERIORITY_OR_OTHER|||||||0.4967|||||||Wilcoxon (Mann-Whitney)|||||||0.4967
72334411|NCT01018134|144191703|SUPERIORITY_OR_OTHER|||||||0.0749|||||||Wilcoxon (Mann-Whitney)|||||||0.0749
72334412|NCT01018134|144191704|SUPERIORITY_OR_OTHER|||||||0.2442|||||||Wilcoxon (Mann-Whitney)|||||||0.2442
72334413|NCT01018134|144191704|SUPERIORITY_OR_OTHER|||||||0.2664|||||||Wilcoxon (Mann-Whitney)|||||||0.2664
72334414|NCT01018134|144191704|SUPERIORITY_OR_OTHER|||||||0.1328|||||||Wilcoxon (Mann-Whitney)|||||||0.1328
72334415|NCT01018134|144191704|SUPERIORITY_OR_OTHER|||||||0.0528|||||||Wilcoxon (Mann-Whitney)|||||||0.0528
72334416|NCT01018134|144191704|SUPERIORITY_OR_OTHER|||||||0.0297|||||||Wilcoxon (Mann-Whitney)|||||||0.0297
72334417|NCT01018134|144191704|SUPERIORITY_OR_OTHER|||||||0.0093|||||||Wilcoxon (Mann-Whitney)|||||||0.0093
72334418|NCT01018134|144191704|SUPERIORITY_OR_OTHER|||||||0.223|||||||Wilcoxon (Mann-Whitney)|||||||0.2230
72334419|NCT01018134|144191704|SUPERIORITY_OR_OTHER|||||||0.1924|||||||Wilcoxon (Mann-Whitney)|||||||0.1924
72334420|NCT01018134|144191705|SUPERIORITY_OR_OTHER|||||||0.2397|||||||Wilcoxon (Mann-Whitney)|||||||0.2397
72334421|NCT01018134|144191705|SUPERIORITY_OR_OTHER|||||||0.3794|||||||Wilcoxon (Mann-Whitney)|||||||0.3794
72334422|NCT01018134|144191705|SUPERIORITY_OR_OTHER|||||||0.0383|||||||Wilcoxon (Mann-Whitney)|||||||0.0383
72334423|NCT01018134|144191705|SUPERIORITY_OR_OTHER|||||||0.0154|||||||Wilcoxon (Mann-Whitney)|||||||0.0154
72334424|NCT01018134|144191705|SUPERIORITY_OR_OTHER|||||||0.1892|||||||Wilcoxon (Mann-Whitney)|||||||0.1892
72334425|NCT01018134|144191705|SUPERIORITY_OR_OTHER|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||||||0.0010
72334426|NCT01018134|144191705|SUPERIORITY_OR_OTHER|||||||0.0363|||||||Wilcoxon (Mann-Whitney)|||||||0.0363
72334427|NCT01018134|144191705|SUPERIORITY_OR_OTHER|||||||0.2162|||||||Wilcoxon (Mann-Whitney)|||||||0.2162
72334428|NCT02222909|144191706|OTHER|The significance of the difference-in-differences statistic was assessed using randomization inference, a non-parametric permutation test. Confidence intervals were determined by inversion of the test statistic.|Difference in differences|0.0182||||0.63|TWO_SIDED|95.0|-0.12|0.11||We calculated the proportion of permuted statistics with values higher in magnitude than that of the observed adjusted difference in differences (the p-value). We inverted the test statistic to determine confidence intervals.|Randomization inference||The estimation parameter is the difference between the average adjusted change in the monthly ED visits and hospital days from the pre- to post- intervention periods for the patients assigned to the iCBOs as compared to the cCBOs.|The difference between the average sum of the number of days spent in the hospital and ED visits in the past month, pre- and post-intervention, adjusted for pre- intervention variables, was calculated for each patients. The average change scores among patients assigned to each CBO defined the CBO-level outcomes. We calculated a weighted average of the CBO outcomes separately for the iCBOs and cCBOs, defining the difference-in-differences statistic as the difference between the two averages.||0.11|-0.12|0.63
72425389|NCT03560258|144362083|SUPERIORITY|||||||0.137|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm A: p24CE/full-length Gag DNA and Arm B: Full-length Gag DNA in additional number of CEs with a CD4 or CD8 T cell response from week 0 to week 26.||||0.137
72425390|NCT03560258|144362083|SUPERIORITY|||||||0.014|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm A: p24CE/full-length Gag DNA and Arm C: Placebo in additional number of CEs with a CD4 or CD8 T cell response from week 0 to week 26.||||0.014
72425391|NCT03560258|144362083|SUPERIORITY|||||||0.1|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm B: Full-length Gag DNA and Arm C: Placebo in additional number of CEs with a CD4 or CD8 T cell response from week 0 to week 26.||||0.100
72425392|NCT03560258|144362085|SUPERIORITY|||||||0.222|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm A: p24CE/full-length Gag DNA and Arm B: Full-length Gag DNA in additional number of CEs with a CD4 T cell response at week 26 from baseline.||||0.222
72425393|NCT03560258|144362085|SUPERIORITY|||||||0.222|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm A: p24CE/full-length Gag DNA and Arm C: Placebo in additional number of CEs with a CD4 T cell response at week 26 from baseline.||||0.222
72425394|NCT03560258|144362085|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm B: Full-length Gag DNA and Arm C: Placebo in additional number of CEs with a CD4 T cell response at week 26 from baseline.||||1.00
72425395|NCT03560258|144362086|SUPERIORITY|||||||0.678|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm A: p24CE/full-length Gag DNA and Arm B: Full-length Gag DNA in additional number of CEs with a CD8 T cell response from week 0 to week 26.||||0.678
72425396|NCT03560258|144362086|SUPERIORITY|||||||0.037|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm A: p24CE/full-length Gag DNA and Arm C: Placebo in additional number of CEs with a CD8 T cell response from week 0 to week 26.||||0.037
72334429|NCT02242435|144191707|SUPERIORITY|||||||0.26||||||Adjusted for baseline WOMAC score.|ANCOVA|||||||0.26
72425397|NCT03560258|144362086|SUPERIORITY|||||||0.1|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm B: Full-length Gag DNA and Arm C: Placebo in additional number of CEs with a CD8 T cell response from week 0 to week 26.||||0.100
72425398|NCT03560258|144362087|SUPERIORITY|||||||0.303|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm A: p24CE/full-length Gag DNA and Arm B: Full-length Gag DNA in change in the magnitude of CD4 T cell responses from week 0 to week 26.||||0.303
72425399|NCT03560258|144362087|SUPERIORITY|||||||0.457|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm A: p24CE/full-length Gag DNA and Arm C: Placebo in change in the magnitude of CD4 T cell responses from week 0 to week 26.||||0.457
72425400|NCT03560258|144362087|SUPERIORITY|||||||0.678|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm B: Full-length Gag DNA and Arm C: Placebo in change in the magnitude of CD4 T cell responses from week 0 to week 26.||||0.678
72425401|NCT03560258|144362088|SUPERIORITY|||||||0.755|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm A: p24CE/full-length Gag DNA and Arm B: Full-length Gag DNA in change in the magnitude of CD8 T cell responses from week 0 to week 26.||||0.755
72425402|NCT03560258|144362088|SUPERIORITY|||||||0.867|||||||Wilcoxon (Mann-Whitney)|||||||0.867
72425403|NCT03560258|144362088|SUPERIORITY|||||||0.521|||||||Wilcoxon (Mann-Whitney)|||||||0.521
72425404|NCT00192023|144362118|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Change to Week 8 Endpoint. Change = Endpoint minus baseline. Model: Change to Week 8=score at Week 8+treatment+site+treatment-by-site interaction. If treatment-by-site interaction isn't significant it will be removed from model.|ANCOVA|||Using an estimate of the common standard deviation of 13 points, the planned sample size will give about 80% power to detect a difference between the groups of 8 points on the SNAP-IV. The sample size was determined using a two-sided test with p=0.05, and assumes that up to 10% of patients will discontinue the study without providing post-baseline efficacy data in Study Period III.||||<0.001
72425405|NCT00192023|144362119|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Change to 8 Week Endpoint. Change = Endpoint minus baseline. Model: Change to 8 Week Endpoint=Score at 8 weeks+treatment+site.|ANCOVA|||||||<0.001
72425406|NCT00192023|144362120|SUPERIORITY_OR_OTHER|||||||0.001||95.0||||P-value for Change to 8 Week Endpoint. Change = Endpoint minus baseline. Model: Change to 8 Week Endpoint=Score at 8 weeks+treatment+site.|ANCOVA|||||||0.001
72425407|NCT00192023|144362121|SUPERIORITY_OR_OTHER|||||||0.836||95.0||||P-value for Change to 8 Week Endpoint. Change = Endpoint minus baseline. Model: Change to 8 Week Endpoint=Score at 8 weeks+treatment+site.|ANCOVA|||||||0.836
72334430|NCT02242435|144191708|SUPERIORITY|||||||0.3||||||Adjustment for baseline WOMAC score.|ANCOVA|||||||0.30
72334431|NCT05312632|144191717|OTHER||||||<|0.001|||||||Wilcoxon signed rank test|||||||<0.001
72334432|NCT05312632|144191718|OTHER||||||<|0.001|||||||Wilcoxon signed rank test|||||||<0.001
72334433|NCT05312632|144191719|OTHER||||||<|0.001|||||||Wilcoxon signed rank test|||||||<0.001
72334434|NCT05312632|144191720|OTHER||||||<|0.001|||||||Wilcoxon signed rank test|||||||<0.001
72334435|NCT05312632|144191721|OTHER|||||||0.013|||||||Wilcoxon signed rank test|||||||0.013
72334436|NCT05312632|144191722|OTHER|||||||0.053|||||||Wilcoxon signed rank test|||||||0.053
72334437|NCT05312632|144191723|OTHER||||||<|0.001|||||||Wilcoxon signed rank test|||||||<0.001
72334438|NCT02019108|144191725|SUPERIORITY||Mean Difference (Final Values)|-0.3||||0.495|TWO_SIDED|95.0|-1.1|0.5||a priori threshold for statistical significance \<0.05|ANCOVA|Controlling for baseline values.||This is the comparison between Gait Modification Group and Walking Only Group at 17 weeks.||0.5|-1.1|0.495
72334439|NCT02019108|144191725|SUPERIORITY||Mean Difference (Final Values)|-0.8||||0.079|TWO_SIDED|95.0|-1.6|0.1||a priori threshold for statistical significance \<0.05|ANCOVA|Controlling for baseline values.||This is the comparison between Gait Modification Group and Walking Only Group at 21 weeks.||0.1|-1.6|0.079
72334440|NCT02019108|144191726|SUPERIORITY||Mean Difference (Final Values)|-1.1||||0.117|TWO_SIDED|95.0|-2.6|0.3||a priori threshold for statistical significance \<0.05|ANCOVA|Controlling for baseline values.||This is the comparison between Gait Modification Group and Walking Only Group at 17 weeks.||0.3|-2.6|0.117
72334441|NCT02019108|144191726|SUPERIORITY||Mean Difference (Final Values)|-1.1||||0.133|TWO_SIDED|95.0|-2.5|0.3||a priori threshold for statistical significance \<0.05|ANCOVA|Controlling for baseline values.||This is the comparison between Gait Modification Group and Walking Only Group at 21 weeks.||0.3|-2.5|0.133
72334442|NCT02019108|144191727|SUPERIORITY||Median Difference (Final Values)|-0.14||||0.125|TWO_SIDED|95.0|-0.31|0.04||a priori threshold for statistical significance \<0.05|ANCOVA|Controlling for baseline values and walking speed.||This is the comparison between Gait Modification Group and Walking Only Group at 17 weeks||0.04|-0.31|0.125
72334443|NCT02019108|144191727|SUPERIORITY||Mean Difference (Final Values)|-0.17||||0.103|TWO_SIDED|95.0|-0.37|0.03||a priori threshold for statistical significance \<0.05|ANCOVA|Controlling for baseline values and walking speed.||This is the comparison between Gait Modification Group and Walking Only Group at 21 weeks||0.03|-0.37|0.103
72334444|NCT02019108|144191728|SUPERIORITY||Mean Difference (Final Values)|-0.26|||<|0.001|TWO_SIDED|95.0|-0.39|-0.12||a priori threshold for statistical significance \<0.05|ANCOVA|Controlling for baseline values and walking speed.||This is the comparison between Gait Modification Group and Walking Only Group at 17 weeks.||-0.12|-0.39|<0.001
72334445|NCT02019108|144191728|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.056|TWO_SIDED|95.0|-0.4|0.01||a priori threshold for statistical significance \<0.05|ANCOVA|Controlling for baseline values and walking speed.||This is the comparison between Gait Modification Group and Walking Only Group at 21 weeks.||0.01|-0.40|0.056
72334446|NCT02019108|144191729|SUPERIORITY||Mean Difference (Final Values)|-0.06||||0.031|TWO_SIDED|95.0|-0.11|-0.01||a priori threshold for statistical significance \<0.05|ANCOVA|Controlling for baseline values and walking speed.||This is the comparison between Gait Modification Group and Walking Only Group at 17 weeks.||-0.01|-0.11|0.031
72334447|NCT02019108|144191729|SUPERIORITY||Mean Difference (Final Values)|-0.06||||0.058|TWO_SIDED|95.0|-0.12|0.0||a priori threshold for statistical significance \<0.05|ANCOVA|Controlling for baseline values and walking speed.||This is the comparison between Gait Modification Group and Walking Only Group at 21 weeks.||0.00|-0.12|0.058
72334448|NCT02019108|144191730|SUPERIORITY||Mean Difference (Final Values)|-9.04|||<|0.001|TWO_SIDED|95.0|-11.22|-6.86||a priori threshold for statistical significance \<0.05.|ANCOVA|Controlling for baseline values and walking speed.||This is the comparison between Gait Modification Group and Walking Only Group at 17 weeks.||-6.86|-11.22|<0.001
72334449|NCT02019108|144191730|SUPERIORITY||Mean Difference (Final Values)|-6.78|||<|0.001|TWO_SIDED|95.0|-8.82|-4.75||a priori threshold for statistical significance \<0.05.|ANCOVA|Controlling for baseline values and walking speed.||This is the comparison between Gait Modification Group and Walking Only Group at 21 weeks.||-4.75|-8.82|<0.001
72334450|NCT02019108|144191731|SUPERIORITY||Mean Difference (Final Values)|-3.7||||0.111|TWO_SIDED|95.0|-8.3|0.9||a priori threshold for statistical significance \<0.05.|ANCOVA|Controlling for baseline values.||This is the comparison between Gait Modification Group and Walking Only Group at 17 weeks.||0.9|-8.3|0.111
72334451|NCT02019108|144191731|SUPERIORITY||Mean Difference (Final Values)|-2.7||||0.232|TWO_SIDED|95.0|-7.3|1.8||a priori threshold for statistical significance \<0.05.|ANCOVA|Controlling for baseline values.||This is the comparison between Gait Modification Group and Walking Only Group at 21 weeks.||1.8|-7.3|0.232
72334452|NCT02019108|144191732|SUPERIORITY||Mean Difference (Final Values)|0.21||||0.462|TWO_SIDED|95.0|-0.36|0.78||a priori threshold for significance \<0.05.|ANCOVA|Controlling for baseline values.||This is the comparison between Gait Modification Group and Walking Only Group at 17 weeks.||0.78|-0.36|0.462
72334453|NCT02019108|144191732|SUPERIORITY||Mean Difference (Final Values)|-0.11||||0.737|TWO_SIDED|95.0|-0.76|0.54||a priori threshold for statistical significance \<0.05.|ANCOVA|Controlling for baseline values.||This is the comparison between Gait Modification Group and Walking Only Group at 21 weeks.||0.54|-0.76|0.737
72334454|NCT02019108|144191733|SUPERIORITY||Mean Difference (Final Values)|-0.03||||0.876|TWO_SIDED|95.0|-0.5|0.43||a priori threshold for statistical significance \<0.05|ANCOVA|Controlling for baseline values and walking speed.||This is the comparison between Gait Modification Group and Walking Only Group at 17 weeks.||0.43|-0.50|0.876
72334455|NCT02019108|144191733|SUPERIORITY||Mean Difference (Final Values)|0.03||||0.897|TWO_SIDED|95.0|-0.43|0.49||a priori threshold for statistical significance \<0.05|ANCOVA|Controlling for baseline values and walking speed.||This is the comparison between Gait Modification Group and Walking Only Group at 21 weeks.||0.49|-0.43|0.897
72334456|NCT01466660|144191764|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.822||||0.0891|TWO_SIDED|95.0|0.655|1.032||p-value was not adjusted for multiple comparisons|Log Rank|Stratified by Epidermal Growth Factor Receptor (EGFR) mutation group and presence of brain metastases at baseline|A Cox proportional hazards model, stratified by EGFR mutation group and presence of baseline brain metastases was used to estimate the hazard ratio calculated as Afatinib divided by Gefitinib.|Exploratory trial, no formal hypotheses were tested.||1.032|0.655|0.0891
72334457|NCT01466660|144191765|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.75||||0.0136|TWO_SIDED|95.0|0.595|0.944||p-value was not adjusted for multiple comparisons|Log Rank|Stratified by EGFR mutation group and presence of brain metastases at baseline|Ratio calculated as Afatinib divided by Gefitinib|Exploratory trial, no formal hypotheses were tested.||0.944|0.595|0.0136
72334458|NCT01466660|144191766|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.862||||0.2343|TWO_SIDED|95.0|0.674|1.101||p-value was not adjusted for multiple comparisons|Log Rank|Stratified by EGFR mutation group and presence of brain metastases at baseline|A Cox proportional hazards model, stratified by EGFR mutation group and presence of baseline brain metastases was used to estimate the hazard ratio calculated as Afatinib divided by Gefitinib.|Exploratory trial, no formal hypotheses were tested.||1.101|0.674|0.2343
72425408|NCT00192023|144362122|SUPERIORITY_OR_OTHER|||||||0.87||95.0||||P-value for Change to 8 Week Endpoint. Change = Endpoint minus baseline. Model: Change to 8 Week Endpoint=Score at 8 weeks+treatment+site.|ANCOVA|||||||0.870
72425409|NCT00192023|144362123|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||P-value for Oppositional Change to 8 Week Endpoint. Change = Endpoint minus baseline. Model: Change to 8 Week Endpoint=Score at 8 weeks+treatment+site.|ANCOVA|||||||0.002
72425410|NCT00192023|144362123|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Cognitive Problems Change to 8 Week Endpoint. Change = Endpoint minus baseline. Model: Change to 8 Week Endpoint=Score at 8 weeks+treatment+site.|ANCOVA|||||||<0.001
72425411|NCT00192023|144362123|SUPERIORITY_OR_OTHER|||||||0.022||95.0||||P-value for Hyperactivity Change to 8 Week Endpoint. Change = Endpoint minus baseline. Model: Change to 8 Week Endpoint=Score at 8 weeks+treatment+site.|ANCOVA|||||||0.022
72425412|NCT00192023|144362123|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for ADHD Index Change to 8 Week Endpoint. Change = Endpoint minus baseline. Model: Change to 8 Week Endpoint=Score at 8 weeks+treatment+site.|ANCOVA|||||||<0.001
72425413|NCT00192023|144362124|SUPERIORITY_OR_OTHER|||||||0.071||95.0||||P-value for Change to 8 Week Endpoint. Change = Endpoint minus baseline. Model: Change to 8 Week Endpoint=Score at 8 weeks+treatment+site.|ANCOVA|||||||0.071
72425414|NCT00192023|144362125|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||P-value for Oppositional Change to 8 Week Endpoint. Change = Endpoint minus baseline. Model: Change to 8 Week Endpoint=Score at 8 weeks+treatment+site.|ANCOVA|||||||0.002
72425415|NCT00192023|144362125|SUPERIORITY_OR_OTHER|||||||0.113||95.0||||P-value for Cognitive Problems Change to 8 Week Endpoint. Change = Endpoint minus baseline. Model: Change to 8 Week Endpoint=Score at 8 weeks+treatment+site.|ANCOVA|||||||0.113
72425416|NCT00192023|144362125|SUPERIORITY_OR_OTHER|||||||0.051||95.0||||P-value for Hyperactivity Change to 8 Week Endpoint. Change = Endpoint minus baseline. Model: Change to 8 Week Endpoint=Score at 8 weeks+treatment+site.|ANCOVA|||||||0.051
72425417|NCT00192023|144362125|SUPERIORITY_OR_OTHER|||||||0.061||95.0||||P-value for ADHD Index Change to 8 Week Endpoint. Change = Endpoint minus baseline. Model: Change to 8 Week Endpoint=Score at 8 weeks+treatment+site.|ANCOVA|||||||0.061
72334459|NCT01466660|144191767|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.307||||0.3235|TWO_SIDED|95.0|0.768|2.223||p-value was not adjusted for multiple comparisons|Regression, Logistic|Stratified for EGFR mutation group and presence of brain metastases at baseline|Ratio calculated as Afatinib divided by Gefitinib|Exploratory trial, no formal hypotheses were tested.||2.223|0.768|0.3235
72425418|NCT01027364|144362168|SUPERIORITY_OR_OTHER_LEGACY||Bleeding Rate Ratio|0.17|||<|0.001|TWO_SIDED|95.0|0.11|0.24||A hierarchical approach was applied to the comparison of the annualized bleeding rates between the prophylaxis arms and the episodic arm.|negative binomial model|||The null hypothesis for the primary endpoint is no difference between any prevention regimen and the on-demand regimen. The sample size of this study was mainly based on clinical rather than statistical considerations. However it was projected to have \> 95% power at the 2-sided 0.05 level of significance, based upon this hypothesis test.||0.24|0.11|<0.001
72425419|NCT01027364|144362168|SUPERIORITY_OR_OTHER_LEGACY||Bleeding Rate Ratio|0.13|||<|0.001|TWO_SIDED|95.0|0.08|0.2||A hierarchical approach was applied to the comparison of the annualized bleeding rates between the prophylaxis arms and the episodic arm.|negative binomial model|||The null hypothesis for the primary endpoint is no difference between any prevention regimen and the on-demand regimen. The sample size of this study was mainly based on clinical rather than statistical considerations.||0.20|0.08|<0.001
72425420|NCT03662997|144362174|SUPERIORITY|In this superiority study the primary efficacy analysis included constructing a two sided 5% significance level, using Fisher's non-parametric permutation test for ordered categorical variables and dichotomous variables for the differences. Numbers, percentages improved, not changed, worsened were analyzed with Mantel-Haenszel Exact Chi square over the course of 4 weeks in a 2x2 weeks treatment period inferiority will be established.||||||0.046||||||Five-layer vs Hydrocellular arm, Weeks 1 \& 3|Chi-squared||||All data presented on the performance of the dressings reflect the FAS populations for the study comparison groups.|||0.046
72425421|NCT03662997|144362174|SUPERIORITY|In this superiority study the primary efficacy analysis included constructing a two sided 5% significance level, using Fisher's non-parametric permutation test for ordered categorical variables and dichotomous variables for the differences. Numbers, percentages improved, not changed, worsened were analyzed with Mantel-Haenszel Exact Chi square over the course of 4 weeks in a 2x2 weeks treatment period inferiority will be established.||||||0.56||||||Five-layer vs Hydrocellular arm; Weeks 2 \& 4|Chi-squared||||All data presented on the performance of the dressings reflect the FAS populations for the study comparison groups.|||0.56
72425422|NCT03662997|144362174|SUPERIORITY|In this superiority study the primary efficacy analysis included constructing a two sided 5% significance level, using Fisher's non-parametric permutation test for ordered categorical variables and dichotomous variables for the differences. Numbers, percentages improved, not changed, worsened were analyzed with Mantel-Haenszel Exact Chi square over the course of 4 weeks in a 2x2 weeks treatment period inferiority will be established.||||||0.01||||||Five-layer vs Hydropolymer arm; Weeks 1 \& 3|Chi-squared||||All data presented on the performance of the dressings reflect the FAS populations for the study comparison groups.|||0.010
72425423|NCT03662997|144362174|SUPERIORITY|In this superiority study the primary efficacy analysis included constructing a two sided 5% significance level, using Fisher's non-parametric permutation test for ordered categorical variables and dichotomous variables for the differences. Numbers, percentages improved, not changed, worsened were analyzed with Mantel-Haenszel Exact Chi square over the course of 4 weeks in a 2x2 weeks treatment period inferiority will be established.||||||0.25||||||Five-layer vs Hydropolymer arm; Weeks 2 \& 4|Chi-squared||||All data presented on the performance of the dressings reflect the FAS populations for the study comparison groups.|||0.25
72425424|NCT03662997|144362175|SUPERIORITY|In this superiority study the primary efficacy analysis included constructing a two sided 5% significance level, using Fisher's non-parametric permutation test for ordered categorical variables and dichotomous variables for the differences. Numbers, percentages improved, not changed, worsened were analyzed with Mantel-Haenszel Exact Chi square over the course of 4 weeks in a 2x2 weeks treatment period inferiority will be established.||||||0.046||||||Five-layer vs Hydrocellular; End of Weeks 1 and 3.|Chi-squared, Corrected||||All data presented on the performance of the dressings reflect the FAS populations for the study comparison groups.|||0.046
72334460|NCT01466660|144191770|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.138||||0.7856|TWO_SIDED|95.0|0.447|2.896||p-value was not adjusted for multiple comparisons|Regression, Logistic|Stratified for EGFR mutation group and presence of brain metastases at baseline|Ratio calculated as Afatinib divided by Gefitinib|Exploratory trial, no formal hypotheses were tested.||2.896|0.447|0.7856
72334461|NCT01466660|144191772|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.45|STANDARD_ERROR_OF_MEAN|1.87||0.0657|TWO_SIDED|95.0|-7.13|0.23||p-value was not adjusted for multiple comparisons|ANCOVA|Adjusted for baseline sum of diameters, EGFR mutation group and presence of brain metastases at baseline|Difference calculated as Afatinib minus Gefitinib|Exploratory trial, no formal hypotheses were tested.||0.23|-7.13|0.0657
72334462|NCT01466660|144191773|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.017||0.1422|TWO_SIDED|95.0|-0.06|0.01||p-value was not adjusted for multiple comparisons|Mixed Models Analysis|Adjusted for EGFR mutation group and presence of brain metastases at baseline|Difference calculated as Afatinib minus Gefitinib|"EQ-5D UK utility score.~Exploratory trial, no formal hypotheses were tested."||0.01|-0.06|0.1422
72334463|NCT01466660|144191773|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.03|STANDARD_ERROR_OF_MEAN|0.016||0.054|TWO_SIDED|95.0|-0.06|0.0||p-value was not adjusted for multiple comparisons|Mixed Models Analysis|Adjusted for EGFR mutation group and presence of brain metastases at baseline|Difference calculated as Afatinib divided by Gefitinib|"EQ-5D Belgium utility score.~Exploratory trial, no formal hypotheses were tested."||0.00|-0.06|0.0540
72334464|NCT01466660|144191773|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.5|STANDARD_ERROR_OF_MEAN|1.21||0.2032|TWO_SIDED|95.0|-3.9|0.8||p-value was not adjusted for multiple comparisons|Mixed Models Analysis|Adjusted for EGFR mutation group and presence of brain metastases at baseline|Difference calculated as Afatinib divided by Gefitinib|"EQ-VAS utility score.~Exploratory trial, no formal hypotheses were tested."||0.8|-3.9|0.2032
72334465|NCT00191724|144191775|SUPERIORITY_OR_OTHER|||||||0.528||95.0||||P-value for effect of drotrecogin alfa (activated) dose in right ventricular function at Day 6|Regression, Linear|||||||0.528
72334466|NCT00191724|144191775|SUPERIORITY_OR_OTHER|||||||0.23||95.0||||P-value for effect of drotrecogin alfa (activated) dose on right ventricular function at Day 90|Regression, Linear|||||||0.230
72334467|NCT00191724|144191776|SUPERIORITY_OR_OTHER|||||||0.018||95.0||||P-value for Dyspnea 90-Day Follow-Up.|Regression, Linear|||||||0.018
72334468|NCT00191724|144191776|SUPERIORITY_OR_OTHER|||||||0.72||95.0||||P-value for Emotional 90 Day Follow-up.|Regression, Linear|||||||0.720
72334469|NCT00191724|144191776|SUPERIORITY_OR_OTHER|||||||0.481||95.0||||P-value for Fatigue 90 Day Follow-Up.|Regression, Linear|||||||0.481
72334470|NCT00191724|144191776|SUPERIORITY_OR_OTHER|||||||0.161||95.0||||P-value for Mastery 90 Day Follow-Up.|Regression, Linear|||||||0.161
72334471|NCT00191724|144191776|SUPERIORITY_OR_OTHER|||||||0.068||95.0||||P-value for Dyspnea 90 Day Follow-Up.|Regression, Linear|||||||0.068
72334472|NCT00191724|144191776|SUPERIORITY_OR_OTHER|||||||0.985||95.0||||P-value for Emotional 90 Day Follow-Up.|Regression, Linear|||||||0.985
72334473|NCT00191724|144191776|SUPERIORITY_OR_OTHER|||||||0.281||95.0||||P-value for Fatigue 90 Day Follow-Up|Regression, Linear|||||||0.281
72334474|NCT00191724|144191776|SUPERIORITY_OR_OTHER|||||||0.273||95.0||||P-value for Mastery 90 Day Follow-Up|Regression, Linear|||||||0.273
72334475|NCT00191724|144191776|SUPERIORITY_OR_OTHER|||||||0.848||95.0||||P-value for Dyspnea 90 Day Follow-Up.|Regression, Linear|||||||0.848
72334476|NCT00191724|144191776|SUPERIORITY_OR_OTHER|||||||0.841||95.0||||P-value for Emotional 90 Day Follow-Up.|Regression, Linear|||||||0.841
72334477|NCT00191724|144191776|SUPERIORITY_OR_OTHER|||||||0.797||95.0||||P-value for Fatigue 90 Day Follow-Up.|Regression, Linear|||||||0.797
72334478|NCT00191724|144191776|SUPERIORITY_OR_OTHER|||||||0.963||95.0||||P-value for Mastery 90 Day Follow-Up.|Regression, Linear|||||||0.963
72334479|NCT00191724|144191776|SUPERIORITY_OR_OTHER|||||||0.149||95.0||||P-value for Dyspnea 90 Day Follow-Up.|Regression, Linear|||||||0.149
72334480|NCT00191724|144191776|SUPERIORITY_OR_OTHER|||||||0.141||95.0||||P-value for Emotional 90 Day Follow-Up.|Regression, Linear|||||||0.141
72334481|NCT00191724|144191776|SUPERIORITY_OR_OTHER|||||||0.774||95.0||||P-value for Fatigue 90 Day Follow-Up.|Regression, Linear|||||||0.774
72334482|NCT00191724|144191776|SUPERIORITY_OR_OTHER|||||||0.394||95.0||||P-value for Mastery 90 Day Follow-Up.|Regression, Linear|||||||0.394
72334483|NCT02301546|144191778|SUPERIORITY||||||<|0.01|||||||Mixed Models Analysis|||||||<0.01
72334484|NCT00396006|144191793|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0195|||||||Wilcoxon signed rank test|||||||0.0195
72334485|NCT00396006|144191797|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||paired t-tests|||||||<0.0001
72334486|NCT00396006|144191798|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||paired t-tests|||||||<0.0001
72334487|NCT00396006|144191800|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1875|||||||Wilcoxon signed rank test|||||||0.1875
72334488|NCT00396006|144191801|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4375|||||||Wilcoxon signed rank|||||||0.4375
72334489|NCT01972308|144191805|SUPERIORITY||Group differences in expected 12 month c|-0.31|||||TWO_SIDED|95.0|-0.64|0.04||||||||0.04|-0.64|
72334490|NCT01972308|144191806|SUPERIORITY||Group differences in expected 12 month c|-0.66|||||TWO_SIDED|95.0|-1.38|-0.01||||||||-0.01|-1.38|
72334491|NCT01972308|144191807|SUPERIORITY||Group differences in expected 12 month c|0.06|||||TWO_SIDED|95.0|-0.33|0.43||||||||0.43|-0.33|
72334492|NCT01972308|144191808|SUPERIORITY||Group differences in expected 12 month c|0.02|||||TWO_SIDED|95.0|-0.42|0.48||||||||0.48|-0.42|
72334493|NCT01972308|144191809|SUPERIORITY||Group differences in expected 12 month c|0.04|||||TWO_SIDED|95.0|-0.1|0.19||||||||0.19|-0.10|
72334494|NCT01972308|144191810|SUPERIORITY||Group differences in expected 12 month c|0.12|||||TWO_SIDED|95.0|-0.24|0.6||||||||0.60|-0.24|
72425425|NCT03662997|144362175|SUPERIORITY|In this superiority study the primary efficacy analysis included constructing a two sided 5% significance level, using Fisher's non-parametric permutation test for ordered categorical variables and dichotomous variables for the differences. Numbers, percentages improved, not changed, worsened were analyzed with Mantel-Haenszel Exact Chi square over the course of 4 weeks in a 2x2 weeks treatment period inferiority will be established.||||||0.01||||||Five-layer vs Hydropolymer; End of Weeks 1 \& 3|Chi-squared, Corrected||||All data presented on the performance of the dressings reflect the FAS populations for the study comparison groups|||0.010
72425426|NCT03662997|144362183|SUPERIORITY|This secondary outcome measure was not planned for at the initiation of the study. Compliance rates were calculated by combining the number incidences that dressings were worn for the full 7 days and when the dressings do not have strike-through during first the week of treatment.|||||<|0.05||||||Five-layer vs Hydrocellular arm, first week of treatment|Chi-squared||||All data presented on the performance of the dressings reflect the FAS populations for the study comparison groups.|||<0.05
72425427|NCT03662997|144362183|SUPERIORITY|This secondary outcome measure was not planned for at the initiation of the study. Compliance rates were calculated by combining the number incidences that dressings were worn for the full 7 days and when the dressings do not have strike-through during the first week of treatment.|||||<|0.05||||||Five-layer vs Hydropolymer, first week of treatment.|Chi-squared||||All data presented on the performance of the dressings reflect the FAS populations for the study comparison groups.|||<0.05
72425428|NCT01121484|144362206|SUPERIORITY_OR_OTHER|||||||0.004|TWO_SIDED|||||Analysis of Covariance used change from baseline at Week 8 as a response variable, site and treatment as factors, and baseline score as a covariate.|ANCOVA|||Null hypothesis: no difference between treatment groups||||0.004
72425429|NCT01121484|144362207|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||CGI-I analyzed as a categorical variable by Cochran-Mantel-Haenszel row-mean-score-difference test using ridit scores, controlling for the effect of region; p-value obtained from the alternative hypothesis of Row Mean Score Differences.|Cochran-Mantel-Haenszel|||||||<0.001
72334495|NCT05898672|144191841|OTHER||Ratio of adjusted geometric means|131.18|||||TWO_SIDED|90.0|115.89|148.48||||||Analysis was performed using mixed effect model with treatment as a fixed effect and participant within sequence as a random effect. Ratio of adjusted geometric means of test to reference was reported; where test treatment is Rosuvastatin 10 mg + Nirmatrelvir 300 mg/ Ritonavir 100 mg and reference treatment is Rosuvastatin 10 mg. Ratio and associated 90% CIs were reported in percentage.||148.48|115.89|
72334496|NCT05898672|144191842|OTHER||Ratio of adjusted geometric means|212.44|||||TWO_SIDED|90.0|174.31|258.9||||||Analysis was performed using mixed effect model with treatment as a fixed effect and participant within sequence as a random effect. Ratio of adjusted geometric means of test to reference was reported; where test treatment is Rosuvastatin 10 mg + Nirmatrelvir 300 mg/ Ritonavir 100 mg and reference treatment is Rosuvastatin 10 mg. Ratio and associated 90% CIs were reported in percentage.||258.90|174.31|
72334497|NCT00744978|144191861|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.42||||0.3873|TWO_SIDED|95.0|-1.37|0.53||ANCOVA model using unstructured covariance structure; Type I error rate for primary hypothesis was 5%; no adjustments made for multiplicity.|ANCOVA|||Difference from placebo. Analyzed using a mixed effects longitudinal linear model with subject (nested within sequence) as a random effect and fixed effects stratum, site, period, sequence, treatment, week, and treatment by week.||0.53|-1.37|0.3873
72334498|NCT00744978|144191862|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.55||||0.2465|TWO_SIDED|95.0|-0.39|1.49||ANCOVA model using unstructured covariance structure; tested using a nominal 5% Type I error rate; no adjustments made for multiplicity.|ANCOVA|||Difference from placebo. Analyzed using a mixed effects longitudinal linear model with subject (nested within sequence) as a random effect and fixed effects stratum, site, period, sequence, treatment, week, and treatment by week.||1.49|-0.39|0.2465
72425430|NCT01121484|144362208|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED|||||Analysis of Covariance used change from baseline at Week 8 as a response variable, site and treatment as factors, and baseline score as a covariate.|ANCOVA|||||||0.002
72425431|NCT01121484|144362209|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED|||||Analysis of Covariance used change from baseline at Week 8 as a response variable, site and treatment as factors, and baseline score as a covariate.|ANCOVA|||||||0.002
72425432|NCT01121484|144362210|SUPERIORITY_OR_OTHER|||||||0.158|TWO_SIDED|||||Analysis of Covariance used change from baseline at Week 8 as a response variable, site and treatment as factors, and baseline score as a covariate.|ANCOVA|||||||0.158
72425433|NCT01121484|144362211|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Analysis of Covariance used change from baseline at Week 8 as a response variable, site and treatment as factors, and baseline score as a covariate.|ANCOVA|||||||<0.001
72425434|NCT02912468|144362222|SUPERIORITY||LS mean difference|-0.89|||<|0.0001|TWO_SIDED|95.0|-1.07|-0.71|||ANCOVA|||Data were analyzed using a hybrid method of the worst-observation carried forward (WOCF) and multiple imputation (MI). The imputed completed data were analyzed by fitting ANCOVA model with corresponding baseline, treatment group, asthma/NSAID-ERD status, prior surgery history, and regions as covariates. Statistical inference obtained from all imputed data was combined using Rubin's rule.||-0.71|-1.07|<0.0001
72334499|NCT00744978|144191863|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.59||||0.2092|TWO_SIDED|95.0|-0.33|1.5||ANCOVA model using unstructured covariance structure; tested using a nominal 5% Type I error rate; no adjustments made for multiplicity.|ANCOVA|||Difference from placebo analyzed using a mixed effects longitudinal linear model with subject (nested within sequence) as a random effect and fixed effects stratum, site, period, sequence, treatment, week, and treatment by week.||1.50|-0.33|0.2092
72334500|NCT00744978|144191864|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.37||||0.4339|TWO_SIDED|95.0|-1.3|0.56||ANCOVA model using unstructured covariance structure; tested using a nominal 5% Type I error rate; no adjustments made for multiplicity.|ANCOVA|||Difference from placebo analyzed using a mixed effects longitudinal linear model with subject (nested within sequence) as a random effect and fixed effects stratum, site, period, sequence, treatment, week, and treatment by week.||0.56|-1.30|0.4339
72334501|NCT00744978|144191865|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.9745|TWO_SIDED|95.0|-0.26|0.27|||ANCOVA|||Difference from placebo analyzed using a mixed effects linear model with subject (nested within sequence) as a random effect, and stratum, site, period, sequence, and treatment as fixed effects.||0.27|-0.26|0.9745
72334502|NCT00744978|144191866|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.68||||0.2852|TWO_SIDED|95.0|-0.57|1.92||ANCOVA model using unstructured covariance structure; tested using a nominal 5% Type I error rate; no adjustments made for multiplicity.|ANCOVA|||Difference from placebo analyzed using a mixed effects longitudinal linear model with subject (nested within sequence) as a random effect and fixed effects stratum, site, period, sequence, treatment, week, and treatment by week.||1.92|-0.57|0.2852
72334503|NCT00744978|144191867|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.28||||0.0468|TWO_SIDED|95.0|0.02|2.53||ANCOVA model using unstructured covariance structure; tested using a nominal 5% Type I error rate; no adjustments made for multiplicity.|ANCOVA|||Difference from placebo analyzed using a mixed effects longitudinal linear model with subject (nested within sequence) as a random effect and fixed effects stratum, site, period, sequence, treatment, week, and treatment by week.||2.53|0.02|0.0468
72334504|NCT00744978|144191868|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.8811|TWO_SIDED|95.0|-0.02|0.03||ANCOVA model using unstructured covariance structure; tested using a nominal 5% Type I error rate; no adjustments made for multiplicity.|ANCOVA|||Difference from placebo analyzed using a mixed effects longitudinal linear model with subject (nested within sequence) as a random effect and fixed effects stratum, site, period, sequence, treatment, week, and treatment by week.||0.03|-0.02|0.8811
72334505|NCT00744978|144191869|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.02||||0.083|TWO_SIDED|95.0|0.0|0.05||ANCOVA model using unstructured covariance structure; tested using a nominal 5% Type I error rate; no adjustments made for multiplicity.|ANCOVA|||Difference from placebo analyzed using a mixed effects longitudinal linear model with subject (nested within sequence) as a random effect and fixed effects stratum, site, period, sequence, treatment, week, and treatment by week.||0.05|-0.00|0.0830
72334506|NCT00744978|144191870|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.7226|TWO_SIDED|95.0|-0.03|0.02||ANCOVA model using unstructured covariance structure; tested using a nominal 5% Type I error rate; no adjustments made for multiplicity.|ANCOVA|||Difference from placebo analyzed using a mixed effects longitudinal linear model with subject (nested within sequence) as a random effect and fixed effects stratum, site, period, sequence, treatment, week, and treatment by week.||0.02|-0.03|0.7226
72334507|NCT00744978|144191871|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.53||||0.5588|TWO_SIDED|95.0|-6.68|3.62||ANCOVA model using unstructured covariance structure; tested using a nominal 5% Type I error rate; no adjustments made for multiplicity.|ANCOVA|||Week 1: difference from placebo. Analyzed using a mixed effects longitudinal linear model with subject (nested within sequence) as a random effect and fixed effects stratum, site, period, sequence, treatment, week, and treatment by week.||3.62|-6.68|0.5588
72334508|NCT00744978|144191872|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.15||||0.1173|TWO_SIDED|95.0|-9.34|1.05||ANCOVA model using unstructured covariance structure; tested using a nominal 5% Type I error rate; no adjustments made for multiplicity.|ANCOVA|||Difference from placebo analyzed using a mixed effects longitudinal linear model with subject (nested within sequence) as a random effect and fixed effects stratum, site, period, sequence, treatment, week, and treatment by week.||1.05|-9.34|0.1173
72425435|NCT02912468|144362223|SUPERIORITY||LS mean difference|-2.06|||<|0.0001|TWO_SIDED|95.0|-2.43|-1.69|||ANCOVA|||Data were analyzed using a hybrid method of the WOCF and MI. The imputed completed data were analyzed by fitting an ANCOVA model with corresponding baseline, treatment group, asthma/NSAID-ERD status, prior surgery history, and regions as covariates. Statistical inference obtained from all imputed data was combined using Rubin's rule.||-1.69|-2.43|<0.0001
72334509|NCT00744978|144191873|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.31||||0.6251|TWO_SIDED|95.0|-6.58|3.96||ANCOVA model using unstructured covariance structure; tested using a nominal 5% Type I error rate; no adjustments made for multiplicity.|ANCOVA|||Difference from placebo analyzed using a mixed effects longitudinal linear model with subject (nested within sequence) as a random effect and fixed effects stratum, site, period, sequence, treatment, week, and treatment by week.||3.96|-6.58|0.6251
72334510|NCT00744978|144191874|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.9109|TWO_SIDED|95.0|-0.05|0.05||ANCOVA model using unstructured covariance structure; tested using a nominal 5% Type I error rate; no adjustments made for multiplicity.|ANCOVA|||Difference from placebo analyzed using a mixed effects longitudinal linear model with subject (nested within sequence) as a random effect and fixed effects stratum, site, period, sequence, treatment, week, and treatment by week.||0.05|-0.05|0.9109
72334511|NCT00744978|144191875|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01||||0.6632|TWO_SIDED|95.0|-0.06|0.04||ANCOVA model using unstructured covariance structure; tested using a nominal 5% Type I error rate; no adjustments made for multiplicity.|ANCOVA|||Difference from placebo analyzed using a mixed effects longitudinal linear model with subject (nested within sequence) as a random effect and fixed effects stratum, site, period, sequence, treatment, week, and treatment by week.||0.04|-0.06|0.6632
72334512|NCT00744978|144191876|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02||||0.545|TWO_SIDED|95.0|-0.07|0.04||ANCOVA model using unstructured covariance structure; tested using a nominal 5% Type I error rate; no adjustments made for multiplicity.|ANCOVA|||Difference from placebo analyzed using a mixed effects longitudinal linear model with subject (nested within sequence) as a random effect and fixed effects stratum, site, period, sequence, treatment, week, and treatment by week.||0.04|-0.07|0.5450
72334513|NCT00744978|144191877|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.02||||0.2799|TWO_SIDED|95.0|-0.02|0.05||ANCOVA model using unstructured covariance structure; tested using a nominal 5% Type I error rate; no adjustments made for multiplicity.|ANCOVA|||Difference from placebo analyzed using a mixed effects longitudinal linear model with subject (nested within sequence) as a random effect and fixed effects stratum, site, period, sequence, treatment, week, and treatment by week.||0.05|-0.02|0.2799
72334514|NCT00744978|144191878|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.9675|TWO_SIDED|95.0|-0.03|0.04||ANCOVA model using unstructured covariance structure; tested using a nominal 5% Type I error rate; no adjustments made for multiplicity.|ANCOVA|||Difference from placebo aAnalyzed using a mixed effects longitudinal linear model with subject (nested within sequence) as a random effect and fixed effects stratum, site, period, sequence, treatment, week, and treatment by week.||0.04|-0.03|0.9675
72334515|NCT00744978|144191879|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01||||0.5008|TWO_SIDED|95.0|-0.05|0.02||ANCOVA model using unstructured covariance structure; tested using a nominal 5% Type I error rate; no adjustments made for multiplicity.|ANCOVA|||Difference from placebo analyzed using a mixed effects longitudinal linear model with subject (nested within sequence) as a random effect and fixed effects stratum, site, period, sequence, treatment, week, and treatment by week.||0.02|-0.05|0.5008
72334516|NCT00744978|144191880|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01||||0.2245|TWO_SIDED|95.0|-0.03|0.01||ANCOVA model using unstructured covariance structure; tested using a nominal 5% Type I error rate; no adjustments made for multiplicity.|ANCOVA|||Difference from placebo analyzed using a mixed effects longitudinal linear model with subject (nested within sequence) as a random effect and fixed effects stratum, site, period, sequence, treatment, week, and treatment by week.||0.01|-0.03|0.2245
72334517|NCT00744978|144191881|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01||||0.4974|TWO_SIDED|95.0|-0.03|0.01||ANCOVA model using unstructured covariance structure; tested using a nominal 5% Type I error rate; no adjustments made for multiplicity.|ANCOVA|||Difference from placebo analyzed using a mixed effects longitudinal linear model with subject (nested within sequence) as a random effect and fixed effects stratum, site, period, sequence, treatment, week, and treatment by week.||0.01|-0.03|0.4974
72334518|NCT00744978|144191882|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.8525|TWO_SIDED|95.0|-0.02|0.02||ANCOVA model using unstructured covariance structure; tested using a nominal 5% Type I error rate; no adjustments made for multiplicity.|ANCOVA|||Difference from placebo analyzed using a mixed effects longitudinal linear model with subject (nested within sequence) as a random effect and fixed effects stratum, site, period, sequence, treatment, week, and treatment by week.||0.02|-0.02|0.8525
72369467|NCT04661579|144249092|OTHER||Vaccine Efficacy|-24.0||||0.369|TWO_SIDED|95.0|-97.0|22.2|||Wald test||Vaccine efficacy (VE) is defined as the percent reduction in the hazard, i.e. one minus the hazard ratio (HR, RTS,S/AS01E Vaccine vs. Rabies vaccine).|Vaccine efficacy against the first PCR-positive P. falciparum infection among adults who were P. falciparum positive at baseline was assessed using Cox proportional hazards regression model with a covariate for group assignment to compare Groups 2 and 5. HIV status, Age (tertiles), and sleep under a bednet were included as covariates.||22.2|-97|0.369
72334519|NCT01218958|144191883|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.751||||0.0245|TWO_SIDED|95.0|0.6|0.94||The Hochberg method was used to adjust P-value for multiple comparisons (ie, 380 mg dose vs. placebo and 190 mg dose vs. placebo).|Andersen-Gill recurrent-event Cox|||"The event rate (percentage) is represented by the number of heavy drinking days divided by number of days at risk. For each day, the active groups' results were contrasted with placebo to form the event rate ratio. Thus, a hazard ratio of 0.75 for the 380 mg group indicates a 25% reduction in heavy drinking compared with that of placebo.~The method of analysis estimates the average ratio over time and accounts for discontinuation. Point/interval estimates for pairwise ratios were derived."||0.940|0.600|0.0245
72425436|NCT02912468|144362224|SUPERIORITY|Hierarchical testing procedure was used to control type I error. For regions outside of Japan, this first secondary endpoint was not tested unless both co-primary endpoints were significant at the 0.05 level. Hierarchical testing continued only when previous endpoint was statistically significant. For Japan submission, LMK was instead a co-primary endpoint which also had to be met before secondary endpoints were tested in the hierarchy. Last endpoint in hierarchy is Week 24 SNOT-22.|LS mean difference|-7.44|||<|0.0001|TWO_SIDED|95.0|-8.35|-6.53||Threshold for significance at 0.05 level.|ANCOVA|||Data were analyzed using a hybrid method of the WOCF and MI. The imputed completed data were analyzed by fitting an ANCOVA model with corresponding baseline, treatment group, asthma/NSAID-ERD status, prior surgery history, and regions as covariates. Statistical inference obtained from all imputed data was combined using Rubin's rule.||-6.53|-8.35|<.0001
72425437|NCT02912468|144362225|SUPERIORITY|Testing according to the hierarchical testing procedure (only performed if previous outcome measures were statistically significant).|LS mean difference|-2.61|||<|0.0001|TWO_SIDED|95.0|-3.04|-2.17||Threshold for significance at 0.05 level.|ANCOVA|||Data were analyzed using a hybrid method of the WOCF and MI. The imputed completed data were analyzed by fitting an ANCOVA model with corresponding baseline, treatment group, asthma/NSAID-ERD status, prior surgery history, and regions as covariates. Statistical inference obtained from all imputed data was combined using Rubin's rule.||-2.17|-3.04|<.0001
72425438|NCT02912468|144362226|SUPERIORITY|Testing according to the hierarchical testing procedure (only performed if previous outcome measures were statistically significant).|LS mean difference|10.56|||<|0.0001|TWO_SIDED|95.0|8.79|12.34||Threshold for significance at 0.05 level.|ANCOVA|||Data were analyzed using a hybrid method of the WOCF and MI. The imputed completed data were analyzed by fitting an ANCOVA model with corresponding baseline, treatment group, asthma/NSAID-ERD status, prior surgery history, and regions as covariates. Statistical inference obtained from all imputed data was combined using Rubin's rule.||12.34|8.79|<.0001
72425439|NCT02912468|144362227|SUPERIORITY|Testing according to the hierarchical testing procedure (only performed if previous outcome measures were statistically significant).|LS mean difference|-1.12|||<|0.0001|TWO_SIDED|95.0|-1.31|-0.93||Threshold for significance at 0.05 level.|ANCOVA|||Data were analyzed using a hybrid method of the WOCF and MI. The imputed completed data were analyzed by fitting an ANCOVA model with corresponding baseline, treatment group, asthma/NSAID-ERD status, prior surgery history, and regions as covariates. Statistical inference obtained from all imputed data was combined using Rubin's rule.||-0.93|-1.31|<.0001
72425440|NCT02912468|144362228|SUPERIORITY|Testing according to the hierarchical testing procedure (only performed if previous outcome measures were statistically significant).|LS mean difference|-21.12|||<|0.0001|TWO_SIDED|95.0|-25.17|-17.06||Threshold for significance at 0.05 level.|ANCOVA|||Data were analyzed using a hybrid method of the WOCF and MI. The imputed completed data were analyzed by fitting an ANCOVA model with corresponding baseline, treatment group, asthma/NSAID-ERD status, prior surgery history, and regions as covariates. Statistical inference obtained from all imputed data was combined using Rubin's rule.||-17.06|-25.17|<.0001
72425441|NCT00406419|144362303|SUPERIORITY||Weighted difference|18.5|||<|0.0001|TWO_SIDED|95.0|11.0|25.9|||Cochran-Mantel-Haenszel|||||25.9|11|< 0.0001
72425442|NCT00406419|144362303|SUPERIORITY||Weighted difference|21.4|||<|0.0001|TWO_SIDED|95.0|14.1|28.8|||Cochran-Mantel-Haenszel|||||28.8|14.1|< 0.0001
72425443|NCT00406419|144362304|SUPERIORITY||Weighted difference|30.8|||<|0.0001|TWO_SIDED|95.0|23.7|37.9|||Cochran-Mantel-Haenszel|||||37.9|23.7|< 0.0001
72425444|NCT00406419|144362304|SUPERIORITY||Weighted difference|34.5|||<|0.0001|TWO_SIDED|95.0|27.4|41.5|||Cochran-Mantel-Haenszel|||||41.5|27.4|< 0.0001
72425445|NCT01535274|144362392|SUPERIORITY||||||<|0.001|||||||ANOVA|||P-values represent comparison of successive set points within anesthetic type (i.e.: Set Point 1 compared to Set Point 2, Set Point 2 compared to Set Point 3, etc.). This P-value was determined for each of set points 1, 2, 3, 4, and 5.||||<0.001
72425446|NCT00856661|144362431|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.45||||0.229|TWO_SIDED|95.0|0.79|2.64|||Regression, Logistic|If no assessment was available for last observation carried forward after baseline, the mRS score was set to 5 if alive, or 6, if otherwise = death||All patients who were treated and had at least one valid post-baseline assessment of the mRS. As death is a valid outcome on the mRS, patients who died within 90 days after IMP administration were included.||2.64|0.79|0.2290
72425447|NCT00856661|144362432|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.98||||0.9401|TWO_SIDED|95.0|0.59|1.62|||Regression, Logistic|||||1.62|0.59|0.9401
72425448|NCT00856661|144362433|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.22||||0.5076|TWO_SIDED|95.0|0.68|2.18|||Regression, Logistic|||All patients treated, who had at least one valid post-baseline assessment of the mRS and with a baseline NIHSS score of 8 to 24. If no assessment was available for last observation carried forward after baseline, the mRS score was set to 5 if the patient was known to be alive, or 6, if otherwise = dead.||2.18|0.68|0.5076
72425449|NCT00856661|144362434|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.12||||0.6146|TWO_SIDED|95.0|0.72|1.75|||Regression, Logistic|||all patients treated, who had at least one valid post-baseline assessment of the mRS. As death is a valid outcome on the mRS, patients who died within 90 days after IMP administration were included||1.75|0.72|0.6146
72425450|NCT00244374|144362469|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.4||||0.05|TWO_SIDED|95.0|0.8|2.44|||Regression, Logistic|Odds ratios adjusted for age, race, sex, years injecting.|Odds for travel in the past 3 months as a risk factor for used (injected/snorted/smoked) heroin in the past 30 days|Adjusted odds with 95% confidence intervals for travel as a risk factor for each behavior.||2.44|0.80|0.05
72425451|NCT00244374|144362469|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.76||||0.01|TWO_SIDED|95.0|1.12|2.76|||Regression, Logistic|Odds ratios adjusted for age, race, sex, years injecting.|Odds for travel in the past 3 months as a risk factor for having Used (injected/snorted/smoked) powder cocaine in the past 30 days|Adjusted odds with 95% confidence intervals for travel as a risk factor for each behavior.||2.76|1.12|0.01
72425452|NCT00244374|144362469|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.56||||0.05|TWO_SIDED|95.0|1.0|2.44|||Regression, Logistic|Odds ratios adjusted for age, race, sex, years injecting.|Odds for travel in the prior 3 months as a risk factor for having Used (injected and/or snorted) crack cocaine in the past 30 days|Adjusted odds with 95% confidence intervals for travel as a risk factor for each behavior.||2.44|1.00|0.05
72334520|NCT01218958|144191883|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.83||||0.0744|TWO_SIDED|95.0|0.677|1.018|||Andersen-Gill recurrent-event Cox model|||||1.018|0.677|0.0744
72425453|NCT00244374|144362469|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.59||||0.03|TWO_SIDED|95.0|0.35|0.98|||Regression, Logistic|Odds ratios adjusted for age, race, sex, years injecting.|Odds for travel in the prior 3 months as a risk factor for having Used (injected/snorted/smoked) methamphetamine in the past 30 days|Adjusted odds with 95% confidence intervals for travel as a risk factor for each behavior.||0.98|0.35|0.03
72425454|NCT00244374|144362469|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.99|||<|0.01|TWO_SIDED|95.0|1.11|3.59|||Regression, Logistic|Odds ratios adjusted for age, race, sex, years injecting.|Odds for travel in the prior 3 months as a risk factor for poly-substance use in the past 30 days|Adjusted odds with 95% confidence intervals for travel as a risk factor for each behavior.||3.59|1.11|<0.01
72425455|NCT00244374|144362469|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.87|||<|0.01|TWO_SIDED|95.0|3.84|12.28|||Regression, Logistic|Odds ratios adjusted for age, race, sex, years injecting.|Odds for travel in the prior 3 months as a risk factor for Heavy drinking (\>14 and \>21 drinks/week for women and men respectively) in the past 30 days|Adjusted odds with 95% confidence intervals for travel as a risk factor for each behavior.||12.28|3.84|<0.01
72334521|NCT01179217|144191887|SUPERIORITY_OR_OTHER_LEGACY||Wilcoxon rank-sum test|0.5||||0.0052|TWO_SIDED|||||"1. The primary analysis was analyzed using a CMH analysis of the number of SCCs using modified ridit scores.~2. P-value (controlling for region and HU use)~3. The null hypothesis of the final analysis was performed at the 0.045 significance level."|Cochran-Mantel-Haenszel|||||||0.0052
72334522|NCT01179217|144191888|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0045|||||||Cochran-Mantel-Haenszel|||||||0.0045
72334523|NCT01179217|144191889|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0888|||||||Cochran-Mantel-Haenszel|||||||0.0888
72334524|NCT01849575|144191902|SUPERIORITY|||||||0.001|||||||ANCOVA|||||||0.001
72425456|NCT00244374|144362469|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.63|||<|0.01|TWO_SIDED|95.0|2.02|6.5|||Regression, Logistic|Odds ratios adjusted for age, race, sex, years injecting.|Adjusted odds for travel in the prior 3 months as a risk factor for Drank until blacked out in the past 30 days|Adjusted odds with 95% confidence intervals for travel as a risk factor for each behavior.||6.50|2.02|<0.01
72425457|NCT00244374|144362469|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.56||||0.04|TWO_SIDED|95.0|0.33|0.93|||Regression, Logistic|Odds ratios adjusted for age, race, sex, years injecting.|Adjusted odds for travel in the prior 3 months as a risk factor for Injected daily, past 30 days|Adjusted odds with 95% confidence intervals for travel as a risk factor for each behavior.||0.93|0.33|0.04
72425458|NCT00244374|144362469|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.16|||<|0.01|TWO_SIDED|95.0|1.37|3.4|||Regression, Logistic|Odds ratios adjusted for age, race, sex, years injecting.|Adjusted odds for travel in the prior 3 months as a risk factor for Median number of injected partners \>= 5 in the past 30 days|Adjusted odds with 95% confidence intervals for travel as a risk factor for each behavior.||3.40|1.37|<0.01
72425459|NCT00244374|144362469|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.26||||0.19|TWO_SIDED|95.0|0.81|1.97|||Regression, Logistic|Odds ratios adjusted for age, race, sex, years injecting.|Adjusted odds for travel in prior 3 months as a risk factor for having Lent a needle/syringe in the past 30 days|Adjusted odds with 95% confidence interval for travel in the prior 3 months as a risk factor for having Lent a needle/syringe in the past 30 days||1.97|0.81|0.19
72425460|NCT00244374|144362469|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.61|||<|0.01|TWO_SIDED|95.0|1.01|2.55|||Regression, Logistic|Odds ratios adjusted for age, race, sex, years injecting.|Adjusted odds for travel in prior 3 months as a risk factor for having Injected with someone else's used needle/syringe in the past 30 days|Adjusted odds ratio with 95 % confidence interval for travel in prior 3 months as a risk factor for having injected with someone else's used needle/syringe in the past 30 days||2.55|1.01|<0.01
72425461|NCT00244374|144362469|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.07|||<|0.01|TWO_SIDED|95.0|1.79|5.27|||Regression, Logistic|Odds ratios adjusted for age, race, sex, years injecting.|Adjusted odds for travel in prior 3 months as a risk factor for having Pooled money to buy drugs in the past 30 days|Adjusted odds with 95% confidence interval for travel in the prior 3 months as a risk factor for having Pooled money to buy drugs in the past 30 days||5.27|1.79|<0.01
72425462|NCT00244374|144362469|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.1|||<|0.01|TWO_SIDED|95.0|1.34|3.32|||Regression, Logistic|Odds ratios adjusted for age, race, sex, years injecting.|Adjusted odds for travel in prior 3 months as a risk factor for having Shared cooker/spook to prepare drugs in the past 30 days|Adjusted odds ratios with 95% confidence interval for travel in prior 3 months as risk factor for risk behaviors||3.32|1.34|<0.01
72334525|NCT04077996|144191917|NON_INFERIORITY|The margin of non inferiority analysis was established at 30%.|Risk Ratio (RR)|1.11|STANDARD_DEVIATION|95.0|<|0.05|TWO_SIDED|95.0|0.91|1.3|||Chi-squared, Corrected|||Summary statistics were computed, and a significance level (α) of 5% has been established.||1.3|0.91|<0.05
72334526|NCT04077996|144191917|NON_INFERIORITY|margin 30%|Risk Ratio (RR)|1.0|STANDARD_DEVIATION|95.0|<|0.05|TWO_SIDED|95.0|||||Fisher Exact|||||||<0.05
72425463|NCT00244374|144362469|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.87|||<|0.01|TWO_SIDED|95.0|1.19|2.95|||Regression, Logistic|Odds ratios adjusted for age, race, sex, years injecting.|Adjusted odds for travel in prior 3 months as a risk factor for having used Backloaded Syringe in the past 30 days|Adjusted odds with 95 % confidence interval for travel as a risk factor for risk behaviors||2.95|1.19|<0.01
72425464|NCT00244374|144362469|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.32||||0.13|TWO_SIDED|95.0|0.83|2.1|||Regression, Logistic|Odds ratios adjusted for age, race, sex, years injecting.|"Adjusted odds for travel in prior 3 months as a risk factor for having done Someone's rinse in the past 30 days"|Adjusted odds with 95% confidence interval for travel in prior 3 months as a risk factor for risk behavior in past 30 days||2.10|0.83|0.13
72425465|NCT00244374|144362469|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.21|||<|0.01|TWO_SIDED|95.0|1.4|3.49|||Regression, Logistic|Odds ratios adjusted for age, race, sex, years injecting.|Adjusted odds for travel in prior 3 months as a risk factor for Median number of sexual partners \>=2 in the past 30 days|Adjusted odds ratios and 95% confidence intervals for travel in prior 3 months as a risk factor for risk behaviors in past 30 days||3.49|1.40|<0.01
72425466|NCT00244374|144362469|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.91||||0.86|TWO_SIDED|95.0|0.45|1.85|||Regression, Logistic|Odds ratios adjusted for age, race, sex, years injecting.|Adjusted odds for travel in prior 3 months as a risk factor for having Traded sex for money or drugs in the past 30 days|Adjusted odds and 95% confidence interval for travel in prior 3 months as a risk factor for risk behaviors in past 30 days||1.85|0.45|0.86
72425467|NCT00244374|144362469|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.09||||0.73|TWO_SIDED|95.0|0.59|2.02|||Regression, Logistic|Odds ratios adjusted for age, race, sex, years injecting.|Adjusted odds for travel in prior 3 months as a risk factor for condom use \>90% (if sexually active)|Adjusted odds and 95% confidence interval for travel in prior 3 months as a risk factor for engaging in risk behavior during the past 30 days||2.02|0.59|0.73
72425468|NCT02341287|144362487|SUPERIORITY||Mean Difference (Net)|14.01|STANDARD_DEVIATION|19.4||0.023|TWO_SIDED|95.0|2.29|25.74||Paired t-test of control average sleep latency vs. heated glove average sleep latency as measured by actigraph.|t-test, 2 sided|||||25.74|2.29|.023
72425469|NCT02341287|144362488|SUPERIORITY|Paired t-test of control average sleep latency vs. heated glove average sleep latency as measured by sleep log.|Mean Difference (Net)|13.51|STANDARD_DEVIATION|16.91|<|0.014|TWO_SIDED|95.0|3.29|23.73|||t-test, 2 sided|||||23.73|3.29|<0.014
72425470|NCT02687412|144362489|SUPERIORITY|||||||0.141|||||||t-test, 2 sided|||||||0.141
72334527|NCT04077996|144191918|NON_INFERIORITY|The margin was established at 30%.|Risk Ratio (RR)|1.0|STANDARD_DEVIATION|95.0|<|0.05|TWO_SIDED|1.0|0.14|6.6|||Fisher Exact|||||6.6|0.14|<0.05
72334528|NCT01818258|144191927|SUPERIORITY|||||||0.4|||||||Fisher Exact|||Comparison for number who experienced at least one grade 3 or higher adverse event. Null hypothesis of no difference between cohorts.||||0.40
72334529|NCT01818258|144191928|SUPERIORITY||||||>|0.999|||||||Fisher Exact|||Comparison for number who experienced at least one grade 3 or higher adverse event related to study treatment. Null hypothesis of no difference between cohorts.||||>0.999
72334530|NCT01818258|144191929|SUPERIORITY||Geometric Mean Ratio|0.77||||0.49|TWO_SIDED|95.0|0.4|1.6|||t-test, 2 sided||Week 1 Geometric Mean Ratio of Severe Malnutrition/Normal Nutrition/Mild Malnutrition|Week 1 Comparison of LPV AUC between cohorts. Null hypothesis of no difference between cohorts.||1.6|0.4|0.49
72334531|NCT01818258|144191929|SUPERIORITY||Geometric Mean Ratio|0.64||||0.23|TWO_SIDED|95.0|0.3|1.4|||t-test, 2 sided||Week 12 Geometric Mean Ratio of Severe Malnutrition/Normal Nutrition/Mild Malnutrition|Week 12 Comparison of LPV AUC between cohorts. Null hypothesis of no difference between cohorts.||1.4|0.3|0.23
72334532|NCT01818258|144191929|SUPERIORITY||Geometric Mean Ratio|0.81||||0.63|TWO_SIDED|95.0|0.3|2.0|||t-test, 2 sided||Week 24 Geometric Mean Ratio of Severe Malnutrition/Normal Nutrition/Mild Malnutrition|Week 24 Comparison of LPV AUC between cohorts. Null hypothesis of no difference between cohorts.||2.0|0.3|0.63
72334533|NCT01818258|144191930|SUPERIORITY||Geometric Mean Ratio|1.06||||0.89|TWO_SIDED|95.0|0.5|2.3|||t-test, 2 sided||Week 1 Geometric Mean Ratio of Severe Malnutrition/Normal Nutrition/Mild Malnutrition|Week 1 Comparison of LPV Clearance between cohorts. Null hypothesis of no difference between cohorts.||2.3|0.5|0.89
72334534|NCT01818258|144191930|SUPERIORITY||Geometric Mean Ratio|1.42||||0.37|TWO_SIDED|95.0|0.7|3.1|||t-test, 2 sided||Week 12 Geometric Mean Ratio of Severe Malnutrition/Normal Nutrition/Mild Malnutrition|Week 12 Comparison of LPV clearance between cohorts. Null hypothesis of no difference between cohorts.||3.1|0.7|0.37
72334535|NCT01818258|144191930|SUPERIORITY||Geometric Mean Ratio|1.23||||0.63|TWO_SIDED|95.0|0.5|2.9|||t-test, 2 sided||Week 24 Geometric Mean Ratio of Severe Malnutrition/Normal Nutrition/Mild Malnutrition|Week 24 Comparison of LPV clearance between cohorts. Null hypothesis of no difference between cohorts.||2.9|0.5|0.63
72334536|NCT01818258|144191931|SUPERIORITY||Geometric Mean Ratio|0.76||||0.42|TWO_SIDED|95.0|0.4|1.5|||t-test, 2 sided||Week 1 Geometric Mean Ratio of Severe Malnutrition/Normal Nutrition/Mild Malnutrition|Week 1 Comparison of RTV AUC between cohorts. Null hypothesis of no difference between cohorts.||1.5|0.4|0.42
72334537|NCT01818258|144191931|SUPERIORITY||Geometric Mean Ratio|0.58||||0.11|TWO_SIDED|95.0|0.3|1.1|||t-test, 2 sided||Week 12 Geometric Mean Ratio of Severe Malnutrition/Normal Nutrition/Mild Malnutrition|Week 12 comparison of RTV AUC between cohorts. Null hypothesis of no difference between cohorts.||1.1|0.3|0.11
72334538|NCT01818258|144191931|SUPERIORITY||Geometric Mean Ratio|0.77||||0.44|TWO_SIDED|95.0|0.4|1.5|||t-test, 2 sided||Week 24 Geometric Mean Ratio of Severe Malnutrition/Normal Nutrition/Mild Malnutrition|Week 24 comparison of RTV AUC between cohorts. Null hypothesis of no difference between cohorts.||1.5|0.4|0.44
72334539|NCT01818258|144191932|SUPERIORITY||Geometric Mean Ratio|1.07||||0.84|TWO_SIDED|95.0|0.5|2.2|||t-test, 2 sided||Week 1 Geometric Mean Ratio of Severe Malnutrition/Normal Nutrition/Mild Malnutrition|Week 1 comparison of RTV clearance between cohorts. Null hypothesis of no difference between cohorts.||2.2|0.5|0.84
72334540|NCT01818258|144191932|SUPERIORITY||Geometric Mean Ratio|1.54||||0.21|TWO_SIDED|95.0|0.8|3.1|||t-test, 2 sided||Week 12 Geometric Mean Ratio of Severe Malnutrition/Normal Nutrition/Mild Malnutrition|Week 12 comparison of RTV clearance between cohorts. Null hypothesis of no difference between cohorts.||3.1|0.8|0.21
72334541|NCT01818258|144191932|SUPERIORITY||Geometric Mean Ratio|1.29||||0.44|TWO_SIDED|95.0|0.7|2.5|||t-test, 2 sided||Week 24 Geometric Mean Ratio of Severe Malnutrition/Normal Nutrition/Mild Malnutrition|Week 24 comparison of RTV clearance between cohorts. Null hypothesis of no difference between cohorts.||2.5|0.7|0.44
72334542|NCT01818258|144191933|SUPERIORITY||Geometric Mean Ratio|0.77||||0.27|TWO_SIDED|95.0|0.5|1.2|||t-test, 2 sided||Week 1 Geometric Mean Ratio of Severe Malnutrition/Normal Nutrition/Mild Malnutrition|Week 1 comparison of 3TC AUC between cohorts. Null hypothesis of no difference between cohorts.||1.2|0.5|0.27
72334543|NCT01818258|144191933|SUPERIORITY||Geometric Mean Ratio|0.6||||0.047|TWO_SIDED|95.0|0.4|1.0|||t-test, 2 sided||Week 12 Geometric Mean Ratio of Severe Malnutrition/Normal Nutrition/Mild Malnutrition|Week 12 comparison of 3TC AUC between cohorts. Null hypothesis of no difference between cohorts.||1.0|0.4|0.047
72334544|NCT01818258|144191933|SUPERIORITY||Geometric Mean Ratio|1.09||||0.76|TWO_SIDED|95.0|0.6|1.9|||t-test, 2 sided||Week 24 Geometric Mean Ratio of Severe Malnutrition/Normal Nutrition/Mild Malnutrition|Week 24 comparison of 3TC AUC between cohorts. Null hypothesis of no difference between cohorts.||1.9|0.6|0.76
72334545|NCT01818258|144191934|SUPERIORITY||Geometric Mean Ratio|0.0||||0.89|TWO_SIDED|95.0|-0.4|0.5|||t-test, 2 sided||Week 1 Geometric Mean Ratio of Severe Malnutrition/Normal Nutrition/Mild Malnutrition|Week 1 comparison of 3TC clearance between cohorts. Null hypothesis of no difference between cohorts.||0.5|-0.4|0.89
72334546|NCT01818258|144191934|SUPERIORITY||Geometric Mean Ratio|1.4||||0.18|TWO_SIDED|95.0|0.8|2.3|||t-test, 2 sided||Week 12 Geometric Mean Ratio of Severe Malnutrition/Normal Nutrition/Mild Malnutrition|Week 12 comparison of 3TC clearance between cohorts. Null hypothesis of no difference between cohorts.||2.3|0.8|0.18
72334547|NCT01818258|144191934|SUPERIORITY||Geometric Mean Ratio|0.85||||0.53|TWO_SIDED|95.0|0.5|1.4|||t-test, 2 sided||Week 24 Geometric Mean Ratio of Severe Malnutrition/Normal Nutrition/Mild Malnutrition|Week 24 comparison of 3TC clearance between cohorts. Null hypothesis of no difference between cohorts.||1.4|0.5|0.53
72334548|NCT01818258|144191935|SUPERIORITY||Geometric Mean Ratio|1.27||||0.39|TWO_SIDED|95.0|0.7|2.2|||t-test, 2 sided||Week 1 Geometric Mean Ratio of Severe Malnutrition/Normal Nutrition/Mild Malnutrition|Week 1 comparison of ZDV AUC between cohorts. Null hypothesis of no difference between cohorts.||2.2|0.7|0.39
72425471|NCT02687412|144362490|SUPERIORITY||Mean Difference (Final Values)|-4041.0|STANDARD_ERROR_OF_MEAN|1831.042||0.029|TWO_SIDED|95.0|-7672.301|-411.065|||t-test, 2 sided|||||-411.065|-7672.301|0.029
72334549|NCT01818258|144191935|SUPERIORITY||Geometric Mean Ratio|1.37||||0.43|TWO_SIDED|95.0|0.6|3.0|||t-test, 2 sided||Week 12 Geometric Mean Ratio of Severe Malnutrition/Normal Nutrition/Mild Malnutrition|Week 12 comparison of ZDV AUC between cohorts. Null hypothesis of no difference between cohorts.||3.0|0.6|0.43
72425472|NCT02687412|144362491|SUPERIORITY||Mean Difference (Final Values)|20.3739|STANDARD_ERROR_OF_MEAN|6.4198||0.002|TWO_SIDED|95.0|7.6414|33.1065|||t-test, 2 sided|||||33.1065|7.6414|0.002
72425473|NCT02687412|144362492|SUPERIORITY|||||||0.014|||||||Chi-squared|||||||0.014
72425474|NCT02687412|144362493|SUPERIORITY|||||||0.034|||||||Chi-squared|||||||0.034
72425475|NCT02687412|144362494|SUPERIORITY|||||||1|||||||Chi-squared|||||||1
72425476|NCT02687412|144362495|SUPERIORITY|||||||1|||||||Chi-squared|||||||1
72425477|NCT02687412|144362496|SUPERIORITY|||||||1|||||||Chi-squared|||||||1
72425478|NCT02687412|144362497|SUPERIORITY|||||||1|||||||Chi-squared|||||||1
72334550|NCT01818258|144191935|SUPERIORITY||Geometric Mean Ratio|1.52||||0.003|TWO_SIDED|95.0|1.2|2.0|||t-test, 2 sided||Week 24 Geometric Mean Ratio of Severe Malnutrition/Normal Nutrition/Mild Malnutrition|Week 24 comparison of ZDV AUC between cohorts. Null hypothesis of no difference between cohorts.||2.0|1.2|0.003
72425479|NCT02687412|144362498|SUPERIORITY||Mean Difference (Final Values)|-0.10046|STANDARD_ERROR_OF_MEAN|0.1915||0.601|TWO_SIDED|95.0|-0.4819|0.2817|||t-test, 2 sided|||||0.2817|-0.4819|0.601
72425480|NCT02687412|144362499|SUPERIORITY||Mean Difference (Final Values)|164.746|STANDARD_ERROR_OF_MEAN|317.79||0.605|TWO_SIDED|95.0|-465.0|794.0|||t-test, 2 sided|||||794|-465|0.605
72425481|NCT01966796|144362508|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002|TWO_SIDED|95.0|||||ANOVA|||The incidence of MDR pathogens (6.7%, 25.5%, 36.9% and 44.6% in PSI II, III, IV, and V, respectively, p=0.002) and mortality rate (0, 5.9%, 12.3%, and 23.8%, respectively, p\<0.001) increased with increasing PSI||||0.002
72425482|NCT00474929|144362522|SUPERIORITY_OR_OTHER||Maximum Tolerated Dose (MTD) Level|1.0|||||TWO_SIDED||||||||Dose Level 1 was chosen as the MTD due to PI concerns about adverse events and frequent dose reductions seen on later cycles at dose level 2. For the best interest of the patients, dose level 1 was chosen as the MTD and the dose level for Phase II.|The Maximum Tolerated Dose (MTD) is defined as the dose level below the lowest dose that induces dose-limiting toxicity (DLT) in at least one-third of patients (at least 2 of a maximum of 6 new patients).||||
72425483|NCT03661996|144362528|NON_INFERIORITY|The treatment regimen is Clinically Acceptable if it is no more than 30% worse than the Breg Cooling Control Group and the lower bound of the 95% CI for Ratio of Geometric LS Means is greater than 0.7.|Ratio of Geometric LS Means|1.063|STANDARD_ERROR_OF_MEAN|1.0216|||TWO_SIDED|95.0|1.019|1.108|||||Parameter dispersion is the Standard Error of the Ratio of Geometric LS Means|Geometric LS means, ratio of geometric LS means, with Breg Cooling as control, and 95% CIs were obtained from an ANCOVA model on the natural log-transformed composite outcome with cooling and injection procedure as the main effect. Baseline K-L grade, baseline BMI category, sex, and reverse-scored and normalized index knee procedure pain were included as covariates. Estimates and CIs on the log scale were exponentiated to obtain ratios of geometric means on the original scale.||1.108|1.019|
72425484|NCT03661996|144362528|NON_INFERIORITY|The treatment regimen is Clinically Acceptable if it is no more than 30% worse than the Breg Cooling Control Group and the lower bound of the 95% CI for Ratio of Geometric LS Means is greater than 0.7.|Ratio of Geometric LS Means|0.959|STANDARD_ERROR_OF_MEAN|1.0221|||TWO_SIDED|95.0|0.919|1.001|||||Parameter dispersion is the Standard Error of the Ratio of Geometric LS Means|Geometric LS means, ratio of geometric LS means, with Breg Cooling as control, and 95% CIs were obtained from an ANCOVA model on the natural log-transformed composite outcome with cooling and injection procedure as the main effect. Baseline K-L grade, baseline BMI category, sex, and reverse-scored and normalized index knee procedure pain were included as covariates. Estimates and CIs on the log scale were exponentiated to obtain ratios of geometric means on the original scale.||1.001|0.919|
72425485|NCT03661996|144362528|NON_INFERIORITY|The treatment regimen is Clinically Acceptable if it is no more than 30% worse than the Breg Cooling Control Group and the lower bound of the 95% CI for Ratio of Geometric LS Means is greater than 0.7.|Ratio of Geometric LS Means|1.013|STANDARD_ERROR_OF_MEAN|1.0219|||TWO_SIDED|95.0|0.97|1.057|||||Parameter dispersion is the Standard Error of the Ratio of Geometric LS Means|Geometric LS means, ratio of geometric LS means, with Breg Cooling as control, and 95% CIs were obtained from an ANCOVA model on the natural log-transformed composite outcome with cooling and injection procedure as the main effect. Baseline K-L grade, baseline BMI category, sex, and reverse-scored and normalized index knee procedure pain were included as covariates. Estimates and CIs on the log scale were exponentiated to obtain ratios of geometric means on the original scale.||1.057|0.970|
72425486|NCT03661996|144362528|NON_INFERIORITY|The treatment regimen is Clinically Acceptable if it is no more than 30% worse than the Breg Cooling Control Group and the lower bound of the 95% CI for Ratio of Geometric LS Means is greater than 0.7.|Ratio of Geometric LS Means|0.931|STANDARD_ERROR_OF_MEAN|1.0219|||TWO_SIDED|95.0|0.892|0.972|||||Parameter dispersion is the Standard Error of the Ratio of Geometric LS Means|Geometric LS means, ratio of geometric LS means, with Breg Cooling as control, and 95% CIs were obtained from an ANCOVA model on the natural log-transformed composite outcome with cooling and injection procedure as the main effect. Baseline K-L grade, baseline BMI category, sex, and reverse-scored and normalized index knee procedure pain were included as covariates. Estimates and CIs on the log scale were exponentiated to obtain ratios of geometric means on the original scale.||0.972|0.892|
72334551|NCT01818258|144191936|SUPERIORITY||Geometric Mean Ratio|0.6||||0.09|TWO_SIDED|95.0|0.3|1.1|||t-test, 2 sided||Week 1 Geometric Mean Ratio of Severe Malnutrition/Normal Nutrition/Mild Malnutrition|Week 1 comparison of ZDV clearance between cohorts. Null hypothesis of no difference between cohorts.||1.1|0.3|0.090
72425487|NCT03661996|144362529|SUPERIORITY|A within-group analysis of change at Week 8 from baseline.|Least Squares Mean Change From Baseline|17.15|STANDARD_ERROR_OF_MEAN|1.396|<|0.0001|TWO_SIDED|95.0|14.4|19.9|||Mixed Models Analysis|LS means, 95% CIs, and P values were obtained from a mixed model for repeated measures (MMRM)||Results are summarized by subject type and the injected knee. The KOOS subscale scores are derived and normalized. Higher scores indicate improvement. Model terms included pooled site group, baseline K-L grade category, baseline BMI category, sex, study visit, and baseline subscale score as covariates.||19.90|14.40|<0.0001
72425488|NCT03661996|144362529|SUPERIORITY|A within-group analysis of change at Week 8 from baseline.|Mean Difference (Final Values)|20.41|STANDARD_ERROR_OF_MEAN|3.692|<|0.0001|TWO_SIDED|95.0|12.79|28.03|||Mixed Models Analysis|LS means, 95% CIs, and P values were obtained from a mixed model for repeated measures (MMRM)||Results are summarized by subject type and the injected knee. The KOOS subscale scores are derived and normalized. Higher scores indicate improvement. Model terms included pooled site group, baseline K-L grade category, baseline BMI category, sex, study visit, and baseline subscale score as covariates.||28.03|12.79|<0.0001
72334552|NCT01818258|144191936|SUPERIORITY||Geometric Mean Ratio|0.6||||0.23|TWO_SIDED|95.0|0.3|1.4|||t-test, 2 sided||Week 12 Geometric Mean Ratio of Severe Malnutrition/Normal Nutrition/Mild Malnutrition|Week 12 comparison of ZDV clearance between cohorts. Null hypothesis of no difference between cohorts.||1.4|0.3|0.23
72425489|NCT03661996|144362529|SUPERIORITY|A within-group analysis of change at Week 8 from baseline.|Least Squares Mean Change From Baseline|20.05|STANDARD_ERROR_OF_MEAN|0.819|<|0.0001|TWO_SIDED|95.0|18.44|21.66|||Mixed Models Analysis|LS means, 95% CIs, and P values were obtained from a mixed model for repeated measures (MMRM)||Results are summarized by subject type and the injected knee. The KOOS subscale scores are derived and normalized. Higher scores indicate improvement. Model terms included pooled site group, baseline K-L grade category, baseline BMI category, sex, study visit, and baseline subscale score as covariates.||21.66|18.44|<0.0001
72425490|NCT03661996|144362529|SUPERIORITY|A within-group analysis of change at Week 8 from baseline.|Least Squares Mean Change From Baseline|18.4|STANDARD_ERROR_OF_MEAN|1.011|<|0.0001|TWO_SIDED|95.0|16.41|20.38|||Mixed Models Analysis|LS means, 95% CIs, and P values were obtained from a mixed model for repeated measures (MMRM)||Results are summarized by subject type and the injected knee. The KOOS subscale scores are derived and normalized. Higher scores indicate improvement. Model terms included pooled site group, baseline K-L grade category, baseline BMI category, sex, study visit, and baseline subscale score as covariates.||20.38|16.41|<0.0001
72425491|NCT03661996|144362530|SUPERIORITY|A within-group analysis of change at Week 8 from baseline.|Least Squares Mean Change From Baseline|22.45|STANDARD_ERROR_OF_MEAN|1.478|<|0.0001|TWO_SIDED|95.0|19.54|25.37|||Mixed Models Analysis|LS means, 95% CIs, and P values were obtained from a mixed model for repeated measures (MMRM)||Results are summarized by subject type and the injected knee. The KOOS subscale scores are derived and normalized. Higher scores indicate improvement. Model terms included pooled site group, baseline K-L grade category, baseline BMI category, sex, study visit, and baseline subscale score as covariates.||25.37|19.54|<0.0001
72425492|NCT03661996|144362530|SUPERIORITY|A within-group analysis of change at Week 8 from baseline.|Least Squares Mean Change From Baseline|23.9|STANDARD_ERROR_OF_MEAN|4.613|<|0.0001|TWO_SIDED|95.0|14.38|33.42|||Mixed Models Analysis|LS means, 95% CIs, and P values were obtained from a mixed model for repeated measures (MMRM)||Results are summarized by subject type and the injected knee. The KOOS subscale scores are derived and normalized. Higher scores indicate improvement. Model terms included pooled site group, baseline K-L grade category, baseline BMI category, sex, study visit, and baseline subscale score as covariates.||33.42|14.38|<0.0001
72425493|NCT03661996|144362530|SUPERIORITY|A within-group analysis of change at Week 8 from baseline.|Least Squares Mean Change From Baseline|25.62|STANDARD_ERROR_OF_MEAN|0.865|<|0.0001|TWO_SIDED|95.0|23.92|27.32|||Mixed Models Analysis|LS means, 95% CIs, and P values were obtained from a mixed model for repeated measures (MMRM)||Results are summarized by subject type and the injected knee. The KOOS subscale scores are derived and normalized. Higher scores indicate improvement. Model terms included pooled site group, baseline K-L grade category, baseline BMI category, sex, study visit, and baseline subscale score as covariates.||27.32|23.92|<0.0001
72425494|NCT03661996|144362530|SUPERIORITY|A within-group analysis of change at Week 8 from baseline.|Least Squares Mean Change From Baseline|22.1|STANDARD_ERROR_OF_MEAN|1.053|<|0.0001|TWO_SIDED|95.0|20.03|24.17|||Mixed Models Analysis|LS means, 95% CIs, and P values were obtained from a mixed model for repeated measures (MMRM)||Results are summarized by subject type and the injected knee. The KOOS subscale scores are derived and normalized. Higher scores indicate improvement. Model terms included pooled site group, baseline K-L grade category, baseline BMI category, sex, study visit, and baseline subscale score as covariates.||24.17|20.03|<0.0001
72425495|NCT03661996|144362531|SUPERIORITY|A within-group analysis of change at Week 8 from baseline.|Least Squares Mean Change From Baseline|21.1|STANDARD_ERROR_OF_MEAN|1.74|<|0.0001|TWO_SIDED|95.0|17.6|24.5|||Mixed Models Analysis|LS means, 95% CIs, and P values were obtained from a mixed model for repeated measures (MMRM)||Results are summarized by subject type and the injected knee. The KOOS subscale scores are derived and normalized. Higher scores indicate improvement. Model terms for pooled site group, baseline K-L grade category, baseline BMI category (\<30 kg/m2, ≥30 kg/m2), sex, study visit, and baseline KOOS subscale score as covariates. Study visit was included in the model as a categorical variable.||24.5|17.6|<0.0001
72425496|NCT03661996|144362531|SUPERIORITY|A within-group analysis of change at Week 8 from baseline.|Least Squares Mean Change From Baseline|25.3|STANDARD_ERROR_OF_MEAN|6.06||0.0003|TWO_SIDED|95.0|12.7|37.8|||Mixed Models Analysis|LS means, 95% CIs, and P values were obtained from a mixed model for repeated measures (MMRM)||Results are summarized by subject type and the injected knee. The KOOS subscale scores are derived and normalized. Higher scores indicate improvement. Model terms for pooled site group, baseline K-L grade category, baseline BMI category (\<30 kg/m2, ≥30 kg/m2), sex, study visit, and baseline KOOS subscale score as covariates. Study visit was included in the model as a categorical variable.||37.8|12.7|0.0003
72425497|NCT03661996|144362531|SUPERIORITY|A within-group analysis of change at Week 8 from baseline.|Least Squares Mean Change From Baseline|25.85|STANDARD_ERROR_OF_MEAN|1.035|<|0.0001|TWO_SIDED|95.0|23.82|27.88|||Mixed Models Analysis|LS means, 95% CIs, and P values were obtained from a mixed model for repeated measures (MMRM)||Results are summarized by subject type and the injected knee. The KOOS subscale scores are derived and normalized. Higher scores indicate improvement. Model terms for pooled site group, baseline K-L grade category, baseline BMI category (\<30 kg/m2, ≥30 kg/m2), sex, study visit, and baseline KOOS subscale score as covariates. Study visit was included in the model as a categorical variable.||27.88|23.82|<0.0001
72425498|NCT03661996|144362531|SUPERIORITY|A within-group analysis of change at Week 8 from baseline.|Least Squares Mean Change From Baseline|23.34|STANDARD_ERROR_OF_MEAN|1.238|<|0.0001|TWO_SIDED|95.0|20.91|25.78|||Mixed Models Analysis|LS means, 95% CIs, and P values were obtained from a mixed model for repeated measures (MMRM)||Results are summarized by subject type and the injected knee. The KOOS subscale scores are derived and normalized. Higher scores indicate improvement. Model terms for pooled site group, baseline K-L grade category, baseline BMI category (\<30 kg/m2, ≥30 kg/m2), sex, study visit, and baseline KOOS subscale score as covariates. Study visit was included in the model as a categorical variable.||25.78|20.91|<0.0001
72334553|NCT01818258|144191936|SUPERIORITY||Geometric Mean Ratio|0.64||||0.0003|TWO_SIDED|95.0|0.5|0.8|||t-test, 2 sided||Week 24 Geometric Mean Ratio of Severe Malnutrition/Normal Nutrition/Mild Malnutrition|Week 24 comparison of ZDV clearance between cohorts. Null hypothesis of no difference between cohorts.||0.8|0.5|0.0003
72334554|NCT01818258|144191937|SUPERIORITY||Odds Ratio (OR)|0.54||||0.17|TWO_SIDED|95.0|0.22|1.29|||Mixed Models Analysis||Odds Ratio (SAM/non-SAM) for Lopinavir Ctrough \>= 1 ug/mL through 48 weeks|Odds ratio (SAM/non-SAM) of Ctrough \>=1 ug/mL from entry through 48 weeks from repeated measures mixed model, with the null hypothesis that the odds ratio is equal to zero (no difference between cohorts in odds of Ctrough \>=1 ug/mL).||1.29|0.22|0.17
72334555|NCT01818258|144191938|SUPERIORITY||Mean Difference (Final Values)|-2.4||||0.003|TWO_SIDED|95.0|-3.9|-0.9|||t-test, 2 sided||Severe Malnutrition Cohort - Normal Nutrition/Mild Malnutrition for Week 1 Free Fraction (%) of LPV|Week 1 comparison of LPV free faction. Null hypothesis of no difference between cohorts.||-0.9|-3.9|0.003
72334556|NCT01818258|144191938|SUPERIORITY||Mean Difference (Final Values)|-3.8||||0.011|TWO_SIDED|95.0|-6.6|-1.1|||t-test, 2 sided||Severe Malnutrition - Normal Nutrition/Mild Malnutrition for Week 12 Free Fraction (%) of LPV|Week 12 comparison of LPV free faction. Null hypothesis of no difference between cohorts.||-1.1|-6.6|0.011
72334557|NCT01818258|144191938|SUPERIORITY||Mean Difference (Final Values)|1.0||||0.46|TWO_SIDED|95.0|-2.4|4.4|||t-test, 2 sided||Severe Malnutrition - Normal Nutrition/Mild Malnutrition for Week 24 Free Fraction (%) of LPV|Week 24 comparison of LPV free faction. Null hypothesis of no difference between cohorts.||4.4|-2.4|0.46
72334558|NCT01818258|144191939|SUPERIORITY||Mean Difference (Final Values)|0.7||||0.15|TWO_SIDED|95.0|-0.3|1.7|||t-test, 2 sided||Direction of comparison: Severe Malnutrition - Normal Nutrition/Mild Malnutrition|Difference in cohorts of change in log10 plasma HIV viral load from baseline to week 12. Null hypothesis of no difference between cohorts.||1.7|-0.3|0.15
72334559|NCT01818258|144191939|SUPERIORITY||Mean Difference (Final Values)|0.7||||0.2|TWO_SIDED|95.0|-0.4|1.8|||t-test, 2 sided||Direction of comparison: Severe Malnutrition - Normal Nutrition/Mild Malnutrition|Difference in cohorts of change in log10 plasma HIV viral load from baseline to week 24. Null hypothesis of no difference between cohorts.||1.8|-0.4|0.20
72334560|NCT01818258|144191939|SUPERIORITY||Mean Difference (Final Values)|0.8||||0.13|TWO_SIDED|95.0|-0.2|1.8|||t-test, 2 sided||Direction of comparison: Severe Malnutrition - Normal Nutrition/Mild Malnutrition|Difference in cohorts of change in log10 plasma HIV viral load from baseline to week 36. Null hypothesis of no difference between cohorts.||1.8|-0.2|0.13
72334561|NCT01818258|144191939|SUPERIORITY||Mean Difference (Final Values)|0.8||||0.089|TWO_SIDED|95.0|-0.1|1.8|||t-test, 2 sided||Direction of comparison: Severe Malnutrition - Normal Nutrition/Mild Malnutrition|Difference in cohorts of change in log10 plasma HIV viral load from baseline to week 48. Null hypothesis of no difference between cohorts.||1.8|-0.1|0.089
72334562|NCT01818258|144191940|SUPERIORITY||||||>|0.999|||||||Fisher Exact|||Baseline Comparison, with null hypothesis of no difference between cohorts.||||>0.999
72334563|NCT01818258|144191940|SUPERIORITY|||||||0.15|||||||Fisher Exact|||Week 12 Comparison, with null hypothesis of no difference between cohorts.||||0.15
72334564|NCT01818258|144191940|SUPERIORITY|||||||0.065|||||||Fisher Exact|||Week 24 Comparison, with null hypothesis of no difference between cohorts.||||0.065
72334565|NCT01818258|144191940|SUPERIORITY|||||||0.065|||||||Fisher Exact|||Week 48 Comparison, with null hypothesis of no difference between cohorts.||||0.065
72334566|NCT01818258|144191941|SUPERIORITY||Mean Difference (Final Values)|0.3||||0.89|TWO_SIDED|95.0|-3.9|4.4|||t-test, 2 sided||Direction of comparison: Severe Malnutrition - Normal Nutrition/Mild Malnutrition|Difference in cohorts of change in CD4 percent from baseline to week 12. Null hypothesis of no difference between cohorts.||4.4|-3.9|0.89
72334567|NCT01818258|144191941|SUPERIORITY||Mean Difference (Final Values)|2.5||||0.31|TWO_SIDED|95.0|-2.5|7.6|||t-test, 2 sided||Direction of comparison: Severe Malnutrition - Normal Nutrition/Mild Malnutrition|Difference in cohorts of change in CD4 percent from baseline to week 24. Null hypothesis of no difference between cohorts.||7.6|-2.5|0.31
72334568|NCT01818258|144191941|SUPERIORITY||Mean Difference (Final Values)|3.1||||0.18|TWO_SIDED|95.0|-1.5|7.8|||t-test, 2 sided||Direction of comparison: Severe Malnutrition - Normal Nutrition/Mild Malnutrition|Difference in cohorts of change in CD4 percent from baseline to week 36. Null hypothesis of no difference between cohorts.||7.8|-1.5|0.18
72334569|NCT01818258|144191941|SUPERIORITY||Mean Difference (Final Values)|6.1||||0.018|TWO_SIDED|95.0|1.1|11.0|||t-test, 2 sided||Direction of comparison: Severe Malnutrition - Normal Nutrition/Mild Malnutrition|Difference between cohorts of change in CD4 percent from baseline to week 48. Null hypothesis of no difference between cohorts.||11.0|1.1|0.018
72334570|NCT01818258|144191942|SUPERIORITY||Mean|2.34|||<|0.0001|TWO_SIDED|95.0|1.77|2.91|||t-test, 2 sided|||Null hypothesis: change in WHO weight-for-height Z-score from entry to week 24 equal to 0||2.91|1.77|<0.0001
72334571|NCT01818258|144191942|SUPERIORITY||Mean|2.73|||<|0.0001|TWO_SIDED|95.0|2.09|3.37|||t-test, 2 sided|||Null hypothesis: change in WHO weight-for-height Z-score from entry to week 48 equal to 0||3.37|2.09|<0.0001
72334572|NCT01818258|144191943|SUPERIORITY||Mean|2.63|||<|0.0001|TWO_SIDED|95.0|1.96|3.28|||t-test, 2 sided|||Null hypothesis: change in MUAC from entry to week 24 equal to 0||3.28|1.96|<0.0001
72334573|NCT01818258|144191943|SUPERIORITY||Mean|3.53|||<|0.0001|TWO_SIDED|95.0|2.83|4.24|||t-test, 2 sided|||Null hypothesis: change in MUAC from entry to week 48 equal to 0||4.24|2.83|<0.0001
72425499|NCT03661996|144362532|SUPERIORITY|A within-group analysis of change at Week 8 from baseline.|Least Squares Mean Change From Baseline|20.86|STANDARD_ERROR_OF_MEAN|1.481|<|0.0001|TWO_SIDED|95.0|17.94|23.78|||Mixed Models Analysis|LS means, 95% CIs, and P values were obtained from a mixed model for repeated measures (MMRM)||Results are summarized by subject type and the injected knee. The KOOS subscale scores are derived and normalized. Higher scores indicate improvement. Model terms included pooled site group, baseline K-L grade category, baseline BMI category, sex, study visit, and baseline subscale score as covariates.||23.78|17.94|<0.0001
72425500|NCT03661996|144362532|SUPERIORITY|A within-group analysis of change at Week 8 from baseline.|Least Squares Mean Change From Baseline|25.66|STANDARD_ERROR_OF_MEAN|4.568|<|0.0001|TWO_SIDED|95.0|16.24|35.09|||Mixed Models Analysis|LS means, 95% CIs, and P values were obtained from a mixed model for repeated measures (MMRM)||Results are summarized by subject type and the injected knee. The KOOS subscale scores are derived and normalized. Higher scores indicate improvement. Model terms included pooled site group, baseline K-L grade category, baseline BMI category, sex, study visit, and baseline subscale score as covariates.||35.09|16.24|<0.0001
72425501|NCT03661996|144362532|SUPERIORITY|A within-group analysis of change at Week 8 from baseline.|Least Squares Mean Change From Baseline|25.57|STANDARD_ERROR_OF_MEAN|0.861|<|0.0001|TWO_SIDED|95.0|23.88|27.26|||Mixed Models Analysis|LS means, 95% CIs, and P values were obtained from a mixed model for repeated measures (MMRM)||Results are summarized by subject type and the injected knee. The KOOS subscale scores are derived and normalized. Higher scores indicate improvement. Model terms included pooled site group, baseline K-L grade category, baseline BMI category, sex, study visit, and baseline subscale score as covariates.||27.26|23.88|<0.0001
72425502|NCT03661996|144362532|SUPERIORITY|A within-group analysis of change at Week 8 from baseline.|Least Squares Mean Change From Baseline|25.69|STANDARD_ERROR_OF_MEAN|0.853|<|0.0001|TWO_SIDED|95.0|24.02|27.37|||Mixed Models Analysis|LS means, 95% CIs, and P values were obtained from a mixed model for repeated measures (MMRM)||Results are summarized by subject type and the injected knee. The KOOS subscale scores are derived and normalized. Higher scores indicate improvement. Model terms included pooled site group, baseline K-L grade category, baseline BMI category, sex, study visit, and baseline subscale score as covariates.||27.37|24.02|<0.0001
72425503|NCT03661996|144362533|SUPERIORITY|A within-group analysis of change at Week 8 from baseline.|Least Squares Mean Change From Baseline|25.17|STANDARD_ERROR_OF_MEAN|2.248|<|0.0001|TWO_SIDED|95.0|20.74|29.6|||Mixed Models Analysis|LS means, 95% CIs, and P values were obtained from a mixed model for repeated measures (MMRM)||Results are summarized by subject type and the injected knee. The KOOS subscale scores are derived and normalized. Higher scores indicate improvement. Model terms included pooled site group, baseline K-L grade category, baseline BMI category, sex, study visit, and baseline subscale score as covariates.||29.60|20.74|<0.0001
72334574|NCT01639339|144191948|OTHER||Odds Ratio (OR)|1.55||||0.0311|TWO_SIDED|95.0|1.04|2.32||P-value was calculated using logistic regression model. Test 1 of 5 in a step-down sequential testing procedure.|Regression, Logistic||Treatment comparison between Belimumab 10 mg/kg and placebo using odds ratio and its corresponding 95% confidence interval has been presented.|||2.32|1.04|0.0311
72334575|NCT01639339|144191949|OTHER||Odds Ratio (OR)|1.74||||0.0167|TWO_SIDED|95.0|1.11|2.74||P-value was calculated using logistic regression model. Test 2 of 5 in a step-down sequential testing procedure.|Regression, Logistic||Treatment comparison between Belimumab 10 mg/kg and placebo using odds ratio and its corresponding 95% confidence interval has been presented.|||2.74|1.11|0.0167
72334576|NCT01639339|144191950|OTHER||Odds Ratio (OR)|1.59||||0.0245|TWO_SIDED|95.0|1.06|2.38||P-value was calculated using logistic regression model. Test 3 of 5 in a step-down sequential testing procedure.|Regression, Logistic||Treatment comparison between Belimumab 10 mg/kg and placebo using odds ratio and its corresponding 95% confidence interval has been presented.|||2.38|1.06|0.0245
72334577|NCT01639339|144191951|OTHER||Cox Proportional Hazard|0.51||||0.0014|TWO_SIDED|95.0|0.34|0.77||P-value was calculated using Cox proportional hazards model. Test 4 of 5 in a step-down sequential testing procedure.|Cox proportional hazards model||Treatment comparison between Belimumab 10 mg/kg and placebo using Cox proportional hazards ratio and its corresponding 95% confidence interval has been presented.|||0.77|0.34|0.0014
72334578|NCT01639339|144191952|OTHER|||||||0.0096||||||P-value is rank analysis of covariance model comparing Belimumab and Placebo with covariates for treatment group, induction regimen(CYC vs MMF),race(Black vs Non-black), Baseline uPCR, and eGFR. Test 5 of 5 in step-down sequential testing procedure.|Rank ANCOVA|||||||0.0096
72334579|NCT04730635|144191992|OTHER||Posterior Probability|46.3||||||||||||||There was a threshold of ≥2 percentage points. A posterior probability value \>55% was required to satisfy the primary hypothesis.||||
72334580|NCT04730635|144191993|OTHER||Posterior Probability|80.67||||||||||||||There was a threshold of ≤ 0.1 for this standard deviation change. A posterior probability value \>70% was required to satisfy this secondary hypothesis.||||
72334581|NCT04730635|144191994|OTHER||Posterior Probability|98.8||||||||||||||||||
72334582|NCT02438683|144192024|OTHER||Slope|0.0029|||||TWO_SIDED|95.0|0.0012|0.0046||||The covariance structure is No diagonal Factor Analytic FA0(2).||The regression model with response variable placebo-corrected HR change from baseline (ddHR) and independent variable Plasma concentration includes a fixed slope effect as well as random intercept and slope estimates for each subject. (Primary analysis).||0.0046|0.0012|
72334583|NCT02438683|144192025|OTHER||Mean Difference (Net)|3.85|STANDARD_ERROR_OF_MEAN|1.75|||TWO_SIDED|90.0|0.73|6.97||||For the repeated effect 'time', the covariance structure was chosen to be unstructured.|Mean Difference (Net) is actually the adjusted mean difference calculated as BI 409306 50 mg minus Placebo.|The a repeated measures model included 'period baseline', 'subject baseline' (defined as the arithmetic mean of the 2 period baselines), 'treatment', 'baseline\*time' interaction, 'treatment\*time' interaction and 'time' as fixed effects and subject as random effect (Primary analysis).||6.97|0.73|
72425504|NCT03661996|144362533|SUPERIORITY|A within-group analysis of change at Week 8 from baseline.|Least Squares Mean Change From Baseline|33.11|STANDARD_ERROR_OF_MEAN|5.795|<|0.0001|TWO_SIDED|95.0|21.15|45.07|||Mixed Models Analysis|LS means, 95% CIs, and P values were obtained from a mixed model for repeated measures (MMRM)||Results are summarized by subject type and the injected knee. The KOOS subscale scores are derived and normalized. Higher scores indicate improvement. Model terms included pooled site group, baseline K-L grade category, baseline BMI category, sex, study visit, and baseline subscale score as covariates.||45.07|21.15|<0.0001
72334584|NCT02438683|144192026|OTHER||Mean Difference (Net)|4.93|STANDARD_ERROR_OF_MEAN|1.9|||TWO_SIDED|90.0|1.69|8.16||||For the repeated effect 'time', the covariance structure was chosen to be unstructured.|Mean Difference (Net) is actually the adjusted mean difference calculated as BI 409306 200 mg minus Placebo.|The a repeated measures model included 'period baseline', 'subject baseline' (defined as the arithmetic mean of the 2 period baselines), 'treatment', 'baseline\*time' interaction, 'treatment\*time' interaction and 'time' as fixed effects and subject as random effect (Primary analysis).||8.16|1.69|
72334585|NCT02438683|144192027|OTHER||Slope|0.0011|||||TWO_SIDED|95.0|-0.0009|0.003||||The covariance structure is No diagonal Factor Analytic FA0(2).||The regression model with response variable placebo-corrected QTcF change from baseline (ddQTcF) and independent variable. Plasma concentration includes a fixed slope effect as well as random intercept and slope estimates for each subject (Primary analysis). The covariance structure is No diagonal Factor Analytic FA0(2).||0.0030|-0.0009|
72334586|NCT02438683|144192028|OTHER||Mean Difference (Net)|4.54|STANDARD_ERROR_OF_MEAN|0.65|||TWO_SIDED|90.0|3.39|5.7||||For the repeated effect 'time', the covariance structure was chosen to be unstructured.|Mean Difference (Net) is actually the adjusted mean difference calculated as BI 409306 50 mg minus Placebo.|The a repeated measures model included 'period baseline', 'subject baseline' (defined as the arithmetic mean of the 2 period baselines), 'treatment', 'baseline\*time' interaction, 'treatment\*time' interaction and 'time' as fixed effects and subject as random effect (Primary analysis).||5.70|3.39|
72334587|NCT02438683|144192029|OTHER||Mean Difference (Net)|4.73|STANDARD_ERROR_OF_MEAN|1.99|||TWO_SIDED|90.0|1.34|8.13||||For the repeated effect 'time', the covariance structure was chosen to be unstructured.|Mean Difference (Net) is actually the adjusted mean difference calculated as BI 409306 200 mg minus Placebo.|The a repeated measures model included 'period baseline', 'subject baseline' (defined as the arithmetic mean of the 2 period baselines), 'treatment', 'baseline\*time' interaction, 'treatment\*time' interaction and 'time' as fixed effects and subject as random effect (Primary analysis).||8.13|1.34|
72334588|NCT02438683|144192030|OTHER||Slope|0.0054|||||TWO_SIDED|95.0|0.0032|0.0076||||The covariance structure is Unstructured.||The regression model with response variable placebo-corrected max HR (dHR) and independent variable Plasma concentration includes a fixed slope effect as well as random intercept and slope estimates for each subject. (Primary analysis)||0.0076|0.0032|
72425505|NCT03661996|144362533|SUPERIORITY|A within-group analysis of change at Week 8 from baseline.|Least Squares Mean Change From Baseline|27.8|STANDARD_ERROR_OF_MEAN|1.233|<|0.0001|TWO_SIDED|95.0|25.38|30.23|||Mixed Models Analysis|LS means, 95% CIs, and P values were obtained from a mixed model for repeated measures (MMRM)||Results are summarized by subject type and the injected knee. The KOOS subscale scores are derived and normalized. Higher scores indicate improvement. Model terms included pooled site group, baseline K-L grade category, baseline BMI category, sex, study visit, and baseline subscale score as covariates.||30.23|25.38|<0.0001
72334589|NCT02438683|144192031|OTHER||Slope|-0.0014|||||TWO_SIDED|95.0|-0.0036|0.0008||||The covariance structure is Unstructured.||The regression model with response variable placebo-corrected change from max HR to recovery HR (ddHR) and independent variable Plasma concentration includes a fixed slope effect as well as random intercept estimates for each subject (Primary analysis).||0.0008|-0.0036|
72334590|NCT02438683|144192031|SUPERIORITY_OR_OTHER_LEGACY||Slope|-0.0029|||||TWO_SIDED|95.0|-0.0052|-0.0007||||The covariance structure is Unstructured.||The regression model with response variable placebo-corrected change from max HR to recovery HR (ddHR) and independent variable Plasma concentration includes a fixed slope effect as well as random intercept estimates for each subject (Primary analysis).||-0.0007|-0.0052|
72334591|NCT05463744|144192096|NON_INFERIORITY|0.4% noninferiority margin (NIM)|LS Mean Difference|0.052|||||TWO_SIDED|95.0|-0.077|0.181|||ANCOVA|||||0.181|-0.077|
72334592|NCT05463744|144192097|SUPERIORITY||LS Mean Difference|0.052||||0.432|TWO_SIDED|95.0|-0.077|0.181|||ANCOVA|||||0.181|-0.077|0.432
72334593|NCT05463744|144192098|SUPERIORITY||LS Mean Difference|-0.31||||0.751|TWO_SIDED|95.0|-2.22|1.6|||ANCOVA|||||1.60|-2.22|0.751
72334594|NCT05463744|144192099|SUPERIORITY||Relative Rate|1.02||||0.9|TWO_SIDED|95.0|0.79|1.31|||Negative binomial model|||||1.31|0.79|0.900
72334595|NCT05463744|144192100|NON_INFERIORITY|0.4% noninferiority margin (NIM)|LS Mean Difference|0.024|STANDARD_ERROR_OF_MEAN|0.0682|||TWO_SIDED|95.0|-0.11|0.157|||ANCOVA|||||0.157|-0.110|
72334596|NCT05463744|144192101|SUPERIORITY||LS Mean Difference|-1.22||||0.697|TWO_SIDED|95.0|-7.38|4.93|||ANCOVA|||Week 26||4.93|-7.38|0.697
72334597|NCT05463744|144192101|SUPERIORITY||LS Mean Difference|-4.84||||0.163|TWO_SIDED|95.0|-11.64|1.96|||ANCOVA|||Week 52||1.96|-11.64|0.163
72334598|NCT05463744|144192102|SUPERIORITY||LS Mean Difference|0.02||||0.939|TWO_SIDED|95.0|-0.61|0.66|||Mixed Models Analysis|||Week 23 to Week 26||0.66|-0.61|0.939
72334599|NCT05463744|144192102|SUPERIORITY||LS Mean Difference|0.52||||0.116|TWO_SIDED|95.0|-0.13|1.17|||Mixed Models Analysis|||Week 49 to Week 52||1.17|-0.13|0.116
72334600|NCT05463744|144192103|SUPERIORITY||LS Mean Difference|0.54||||0.61|TWO_SIDED|95.0|-1.54|2.62|||ANCOVA|||||2.62|-1.54|0.610
72334601|NCT05463744|144192104|SUPERIORITY||LS Mean Difference|-8.96||||0.155|TWO_SIDED|95.0|-21.3|3.38|||Mixed Models Analysis|||Week 26||3.38|-21.30|0.155
72334602|NCT05463744|144192104|SUPERIORITY||LS Mean Difference|-6.88||||0.278|TWO_SIDED|95.0|-19.31|5.55|||Mixed Models Analysis|||Week 52||5.55|-19.31|0.278
72334603|NCT05463744|144192105|SUPERIORITY||LS Mean Difference|-3.77|||<|0.001|TWO_SIDED|95.0|-5.52|-2.03|||Mixed Models Analysis|||Week 26||-2.03|-5.52|<0.001
72334604|NCT05463744|144192105|SUPERIORITY||LS Mean Difference|-3.49|||<|0.001|TWO_SIDED|95.0|-5.26|-1.71|||Mixed Models Analysis|||Week 52||-1.71|-5.26|<0.001
72334605|NCT05463744|144192106|SUPERIORITY||LS Mean Difference|-39.28|||<|0.001|TWO_SIDED|95.0|-57.59|-20.98|||Mixed Models Analysis|||Week 26||-20.98|-57.59|<0.001
72334606|NCT05463744|144192106|SUPERIORITY||LS Mean Difference|-35.94|||<|0.001|TWO_SIDED|95.0|-54.44|-17.43|||Mixed Models Analysis|||Week 52||-17.43|-54.44|<0.001
72334607|NCT05463744|144192107|SUPERIORITY||LS Mean Difference|3.19|||<|0.001|TWO_SIDED|95.0|1.32|5.06|||Mixed Models Analysis|||Week 26||5.06|1.32|<0.001
72334608|NCT05463744|144192107|SUPERIORITY||LS Mean Difference|2.8||||0.004|TWO_SIDED|95.0|0.91|4.7|||Mixed Models Analysis|||Week 52||4.70|0.91|0.004
72334609|NCT05463744|144192108|SUPERIORITY||Relative Rate|1.21||||0.016|TWO_SIDED|95.0|1.04|1.41|||Negative binomial model|||||1.41|1.04|0.016
72334610|NCT05463744|144192109|SUPERIORITY||LS Mean Difference|0.086||||0.702|TWO_SIDED|95.0|-0.35|0.53|||Mixed Models Analysis|||Week 26||0.53|-0.35|0.702
72334611|NCT05463744|144192109|SUPERIORITY||LS Mean Difference|0.12||||0.609|TWO_SIDED|95.0|-0.33|0.56|||Mixed Models Analysis|||Week 52||0.56|-0.33|0.609
72334612|NCT05463744|144192110|SUPERIORITY||LS Mean Difference|0.03||||0.681|TWO_SIDED|95.0|-0.13|0.19|||ANCOVA|||Week 23 to Week 26||0.19|-0.13|0.681
72334613|NCT05463744|144192110|SUPERIORITY||LS Mean Difference|0.1||||0.182|TWO_SIDED|95.0|-0.05|0.24|||ANCOVA|||Week 49 to Week 52||0.24|-0.05|0.182
72334614|NCT05463744|144192111|SUPERIORITY||LS Mean Difference|0.0||||0.999|TWO_SIDED|95.0|-2.06|2.05|||ANCOVA|||Week 23 to Week 26||2.05|-2.06|0.999
72334615|NCT05463744|144192112|SUPERIORITY||LS Mean Difference|-0.83||||0.468|TWO_SIDED|95.0|-3.06|1.41|||ANCOVA|||||1.41|-3.06|0.468
72334616|NCT05463744|144192113|OTHER|||||||0.008|||||||Wilcoxon (Mann-Whitney)|||||||0.008
72334617|NCT05463744|144192114|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
72334618|NCT05463744|144192115|SUPERIORITY||LS Mean Difference|0.43||||0.27|TWO_SIDED|95.0|-0.33|1.19|||Mixed Models Analysis|||Physical Component Score: Week 26||1.19|-0.33|0.270
72334619|NCT05463744|144192115|SUPERIORITY||LS Mean Difference|0.73||||0.05|TWO_SIDED|95.0|0.0|1.45|||Mixed Models Analysis|||Physical Component Score: Week 52||1.45|0.000|0.050
72334620|NCT05463744|144192115|SUPERIORITY||LS Mean Difference|0.22||||0.71|TWO_SIDED|95.0|-0.94|1.38|||Mixed Models Analysis|||Mental Component Score: Week 26||1.38|-0.94|0.710
72334621|NCT05463744|144192115|SUPERIORITY||LS Mean Difference|0.45||||0.447|TWO_SIDED|95.0|-0.71|1.61|||Mixed Models Analysis|||Mental Component Score: Week 52||1.61|-0.71|0.447
72334622|NCT01448824|144192117|NON_INFERIORITY_OR_EQUIVALENCE|Up to 12 participants were enrolled in order for 8 to complete the study. The estimated variability in area under the concentration-time curve (AUC) was 20% coefficient of variation following a single dose of 100 mg LY2484595. Assuming that 70% of the total variability is contributed by intra-participant variability, a sample size of 8 participants provides a precision of \~15% for the geometric means ratio in AUC and Cmax of LY2484595 + ketoconazole to LY2484595 alone in log scale.|Ratio of Geometric LS Means|1.94|||||TWO_SIDED|90.0|1.39|2.72||||||||2.72|1.39|
72334623|NCT01448824|144192118|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||1|TWO_SIDED|90.0|-0.5|0.5|||Wilcoxon signed rank|||||0.50|-0.50|1.0000
72334624|NCT01448824|144192119|NON_INFERIORITY_OR_EQUIVALENCE|Up to 12 participants were enrolled in order for 8 to complete the study. The estimated variability in area under the concentration-time curve (AUC) was 20% coefficient of variation following a single dose of 100 mg LY2484595. Assuming that 70% of the total variability is contributed by intra-participant variability, a sample size of 8 participants provides a precision of \~15% for the geometric means ratio in AUC and Cmax of LY2484595 + ketoconazole to LY2484595 alone in log scale.|Ratio of Geometric LS means|2.37|||||TWO_SIDED|90.0|1.77|3.18||||||||3.18|1.77|
72334625|NCT05425732|144192127|OTHER|Miettinen \& Nurminen method|Difference in Percent|-0.9|||||TWO_SIDED|96.0|-2.8|1.1|||||V116 minus PCV20|Injection site erythema: estimated difference in percent||1.1|-2.8|
72334626|NCT05425732|144192127|OTHER|Miettinen \& Nurminen method|Difference in Percent|-12.2|||||TWO_SIDED|95.0|-16.2|-8.2|||||V116 minus PCV20|Injection site pain: estimated difference in percent||-8.2|-16.2|
72334627|NCT05425732|144192127|OTHER|Miettinen \& Nurminen method|Difference in Percent|-2.3|||||TWO_SIDED|95.0|-4.4|-0.2|||||V116 minus PCV20|Injection site swelling: estimated difference in percent||-0.2|-4.4|
72334628|NCT05425732|144192127|OTHER|Miettinen \& Nurminen method|Difference in Percent|2.5|||||TWO_SIDED|95.0|-6.6|10.3|||||V116 minus PCV20|Injection site erythema: estimated difference in percent||10.3|-6.6|
72334629|NCT05425732|144192127|OTHER|Miettinen \& Nurminen method|Difference in Percent|-2.5|||||TWO_SIDED|95.0|-12.7|8.6|||||V116 minus PCV20|Injection site pain: estimated difference in percent||8.6|-12.7|
72334630|NCT05425732|144192127|OTHER|Miettinen \& Nurminen method|Difference in Percent|0.0|||||TWO_SIDED|95.0|-9.2|7.9|||||V116 minus PCV20|Injection site swelling: estimated difference in percent||7.9|-9.2|
72334631|NCT05425732|144192128|OTHER|Miettinen \& Nurminen method|Difference in Percent|0.6|||||TWO_SIDED|95.0|-2.7|3.8|||||V116 minus PCV20|Fatigue: estimated difference in percent||3.8|-2.7|
72334632|NCT05425732|144192128|OTHER|Miettinen \& Nurminen method|Difference in Percent|-1.5|||||TWO_SIDED|95.0|-4.1|1.2|||||V116 minus PCV20|Headache: estimated difference in percent||1.2|-4.1|
72334633|NCT05425732|144192128|OTHER|Miettinen \& Nurminen method|Difference in Percent|-0.8|||||TWO_SIDED|96.0|-2.8|1.2|||||V116 minus PCV20|Myalgia: estimated difference in percent||1.2|-2.8|
72334634|NCT05425732|144192128|OTHER|Miettinen \& Nurminen method|Difference in Percent|0.0|||||TWO_SIDED|95.0|-1.0|1.0|||||V116 minus PCV20|Pyrexia: estimated difference in percent||1.0|-1.0|
72334635|NCT05425732|144192128|OTHER|Miettinen \& Nurminen method|Difference in Percent|6.5|||||TWO_SIDED|95.0|-5.3|17.6|||||V116 minus PCV20|Fatigue: estimated difference in percent||17.6|-5.3|
72334636|NCT05425732|144192128|OTHER|Miettinen \& Nurminen method|Difference in Percent|5.5|||||TWO_SIDED|5.0|-5.5|15.5|||||V116 minus PCV20|Headache: estimated difference in percent||15.5|-5.5|
72334637|NCT05425732|144192128|OTHER|Miettinen \& Nurminen method|Difference in Percent|2.5|||||TWO_SIDED|95.0|-6.8|10.6|||||V116 minus PCV20|Myalgia: estimated difference in percent||10.6|-6.8|
72334638|NCT05425732|144192128|OTHER|Miettinen \& Nurminen method|Difference in Percent|2.5|||||TWO_SIDED|95.0|-2.2|6.2|||||V116 minus PCV20|Pyrexia: estimated difference in percent||6.2|-2.2|
72334639|NCT05425732|144192130|NON_INFERIORITY|A conclusion of non-inferiority is based on the lower bound of the 95% CI for the estimated GMT Ratio (V116/PCV20) being \> 0.5 (one-sided p-value \< 0.025).|GMT Ratio|1.55|||<|0.001|TWO_SIDED|95.0|1.4|1.72||1-sided|cLDA model||V116/PCV20|Serotype 3: V116/PCV20 GMT Ratio||1.72|1.40|<0.001
72334640|NCT05425732|144192130|NON_INFERIORITY|A conclusion of non-inferiority is based on the lower bound of the 95% CI for the estimated GMT Ratio (V116/PCV20) being \> 0.5 (one-sided p-value \< 0.025).|GMT Ratio|0.77|||<|0.001|TWO_SIDED|95.0|0.68|0.88|||cLDA model||V116/PCV20|Serotype 6A: V116/PCV20 GMT Ratio||0.88|0.68|<0.001
72334641|NCT05425732|144192130|NON_INFERIORITY|A conclusion of non-inferiority is based on the lower bound of the 95% CI for the estimated GMT Ratio (V116/PCV20) being \> 0.5 (one-sided p-value \< 0.025).|GMT Ratio|1.06|||<|0.001|TWO_SIDED|95.0|0.95|1.18|||cLDA model||V116/PCV20|Serotype 7F: V116/PCV20 GMT Ratio||1.18|0.95|<0.001
72334642|NCT05425732|144192130|NON_INFERIORITY|A conclusion of non-inferiority is based on the lower bound of the 95% CI for the estimated GMT Ratio (V116/PCV20) being \> 0.5 (one-sided p-value \< 0.025).|GMT Ratio|1.38|||<|0.001|TWO_SIDED|95.0|1.25|1.53|||cLDA model||V116/PCV20|Serotype 8: V116/PCV20 GMT Ratio||1.53|1.25|<0.001
72334643|NCT05425732|144192130|NON_INFERIORITY|A conclusion of non-inferiority is based on the lower bound of the 95% CI for the estimated GMT Ratio (V116/PCV20) being \> 0.5 (one-sided p-value \< 0.025).|GMT Ratio|0.83|||<|0.001|TWO_SIDED|95.0|0.75|0.93|||cLDA model||V116/PCV20|Serotype 10A: V116/PCV20 GMT Ratio||0.93|0.75|<0.001
72334644|NCT05425732|144192130|NON_INFERIORITY|A conclusion of non-inferiority is based on the lower bound of the 95% CI for the estimated GMT Ratio (V116/PCV20) being \> 0.5 (one-sided p-value \< 0.025).|GMT Ratio|1.54|||<|0.001|TWO_SIDED|95.0|1.39|1.72|||cLDA model||V116/PCV20|Serotype 11A: V116/PCV20 GMT Ratio||1.72|1.39|<0.001
72334645|NCT05425732|144192130|NON_INFERIORITY|A conclusion of non-inferiority is based on the lower bound of the 95% CI for the estimated GMT Ratio (V116/PCV20) being \> 0.5 (one-sided p-value \< 0.025).|GMT Ratio|1.06|||<|0.001|TWO_SIDED|95.0|0.92|1.21|||cLDA model||V116/PCV20|Serotype 12F: V116/PCV20 GMT Ratio||1.21|0.92|<0.001
72334646|NCT05425732|144192130|NON_INFERIORITY|A conclusion of non-inferiority is based on the lower bound of the 95% CI for the estimated GMT Ratio (V116/PCV20) being \> 0.5 (one-sided p-value \< 0.025).|GMT Ratio|0.76|||<|0.001|TWO_SIDED|95.0|0.69|0.84|||cLDA model||V116/PCV20|Serotype 19A: V116/PCV20 GMT Ratio||0.84|0.69|<0.001
72334647|NCT05425732|144192130|NON_INFERIORITY|A conclusion of non-inferiority is based on the lower bound of the 95% CI for the estimated GMT Ratio (V116/PCV20) being \> 0.5 (one-sided p-value \< 0.025).|GMT Ratio|0.81|||<|0.001|TWO_SIDED|95.0|0.72|0.92|||cLDA model||V116/PCV20|Serotype 22F: V116/PCV20 GMT Ratio||0.92|0.72|<0.001
72334648|NCT05425732|144192130|NON_INFERIORITY|A conclusion of non-inferiority is based on the lower bound of the 95% CI for the estimated GMT Ratio (V116/PCV20) being \> 0.5 (one-sided p-value \< 0.025).|GMT Ratio|1.15|||<|0.001|TWO_SIDED|95.0|1.01|1.32|||cLDA model||V116/PCV20|Serotype 33F: V116/PCV20 GMT Ratio||1.32|1.01|<0.001
72334649|NCT05425732|144192130|SUPERIORITY|A conclusion of superiority is based on the lower bound of the 95% CI for the estimated GMT ratio (V116/PCV20) being \> 2.0 (one-sided p-value \< 0.025).|GMT Ratio|4.55|||<|0.001|TWO_SIDED|95.0|4.12|5.04|||cLDA model||V116/PCV20|Serotype 9N: V116/PCV20 GMT Ratio||5.04|4.12|<0.001
72334650|NCT05425732|144192130|SUPERIORITY|A conclusion of superiority is based on the lower bound of the 95% CI for the estimated GMT ratio (V116/PCV20) being \> 2.0 (one-sided p-value \< 0.025).|GMT Ratio|3.3|||<|0.001|TWO_SIDED|95.0|2.91|3.74|||cLDA model||V116/PCV20|Serotype 15A: V116/PCV20 GMT Ratio||3.74|2.91|<0.001
72334651|NCT05425732|144192130|SUPERIORITY|A conclusion of superiority is based on the lower bound of the 95% CI for the estimated GMT ratio (V116/PCV20) being \> 2.0 (one-sided p-value \< 0.025).|GMT Ratio|2.03|||<|0.001|TWO_SIDED|95.0|1.77|2.34|||cLDA model||V116/PCV20|Serotype 15C: V116/PCV20 GMT Ratio||2.34|1.77|<0.001
72334652|NCT05425732|144192130|SUPERIORITY|A conclusion of superiority is based on the lower bound of the 95% CI for the estimated GMT ratio (V116/PCV20) being \> 2.0 (one-sided p-value \< 0.025).|GMT Ratio|5.75|||<|0.001|TWO_SIDED|95.0|5.16|6.41|||cLDA model||V116/PCV20|Serotype 16F: V116/PCV20 GMT Ratio||6.41|5.16|<0.001
72334653|NCT05425732|144192130|SUPERIORITY|A conclusion of superiority is based on the lower bound of the 95% CI for the estimated GMT ratio (V116/PCV20) being \> 2.0 (one-sided p-value \< 0.025).|GMT Ratio|16.86|||<|0.001|TWO_SIDED|95.0|14.9|19.09|||cLDA model||V116/PCV20|Serotype 17F: V116/PCV20 GMT Ratio||19.09|14.90|<0.001
72334654|NCT05425732|144192130|SUPERIORITY|A conclusion of superiority is based on the lower bound of the 95% CI for the estimated GMT ratio (V116/PCV20) being \> 2.0 (one-sided p-value \< 0.025).|GMT Ratio|9.66|||<|0.001|TWO_SIDED|95.0|8.66|10.79|||cLDA model||V116/PCV20|Serotype 20A: V116/PCV20 GMT Ratio||10.79|8.66|<0.001
72334655|NCT05425732|144192130|SUPERIORITY|A conclusion of superiority is based on the lower bound of the 95% CI for the estimated GMT ratio (V116/PCV20) being \> 2.0 (one-sided p-value \< 0.025).|GMT Ratio|8.1|||<|0.001|TWO_SIDED|95.0|6.86|9.55|||cLDA model||V116/PCV20|Serotype 23A: V116/PCV20 GMT Ratio||9.55|6.86|<0.001
72334656|NCT05425732|144192130|SUPERIORITY|A conclusion of superiority is based on the lower bound of the 95% CI for the estimated GMT ratio (V116/PCV20) being \> 2.0 (one-sided p-value \< 0.025).|GMT Ratio|10.09|||<|0.001|TWO_SIDED|95.0|8.48|12.0|||cLDA model||V116/PCV20|Serotype 23B: V116/PCV20 GMT Ratio||12.00|8.48|<0.001
72334657|NCT05425732|144192130|SUPERIORITY|A conclusion of superiority is based on the lower bound of the 95% CI for the estimated GMT ratio (V116/PCV20) being \> 2.0 (one-sided p-value \< 0.025).|GMT Ratio|38.71|||<|0.001|TWO_SIDED|95.0|33.87|44.25|||cLDA model||V116/PCV20|Serotype 24F: V116/PCV20 GMT Ratio||44.25|33.87|<0.001
72334658|NCT05425732|144192130|SUPERIORITY|A conclusion of superiority is based on the lower bound of the 95% CI for the estimated GMT ratio (V116/PCV20) being \> 2.0 (one-sided p-value \< 0.025).|GMT Ratio|21.69|||<|0.001|TWO_SIDED|95.0|18.68|25.18|||cLDA model||V116/PCV20|Serotype 31: V116/PCV20 GMT Ratio||25.18|18.68|<0.001
72334659|NCT05425732|144192130|SUPERIORITY|A conclusion of superiority is based on the lower bound of the 95% CI for the estimated GMT ratio (V116/PCV20) being \> 2.0 (one-sided p-value \< 0.025).|GMT Ratio|6.17|||<|0.001|TWO_SIDED|95.0|5.59|6.8|||cLDA model||V116/PCV20|Serotype 35B: V116/PCV20 GMT Ratio||6.80|5.59|<0.001
72334660|NCT05425732|144192131|SUPERIORITY|A conclusion of superiority is based on the lower bound of the 95% CI for the difference \[V116 - PCV20\] between the percentages of participants with a ≥4-fold rise from baseline being \>10 percentage points (one-sided p-value \< 0.025).|Percent Difference|44.7|||<|0.001|TWO_SIDED|95.0|40.7|48.6||1-sided|Stratified Miettinen & Nurminen||V116 minus PCV20|Serotype 9N: V116-PCV20 Percentage Difference||48.6|40.7|<0.001
72334661|NCT05425732|144192131|SUPERIORITY|A conclusion of superiority is based on the lower bound of the 95% CI for the difference \[V116 - PCV20\] between the percentages of participants with a ≥4-fold rise from baseline being \>10 percentage points (one-sided p-value \< 0.025).|Percent Difference|30.9|||<|0.001|TWO_SIDED|95.0|25.8|35.8||1-sided|Stratified Miettinen & Nurminen||V116 minus PCV20|Serotype 15A: V116-PCV20 Percentage Difference||35.8|25.8|<0.001
72334662|NCT05425732|144192131|SUPERIORITY|A conclusion of superiority is based on the lower bound of the 95% CI for the difference \[V116 - PCV20\] between the percentages of participants with a ≥4-fold rise from baseline being \>10 percentage points (one-sided p-value \< 0.025).|Percent Difference|9.2|||<|0.001|TWO_SIDED|95.0|5.6|12.9||1-sided|Stratified Miettinen & Nurminen||V116 minus PCV20|Serotype 15C: V116-PCV20 Percentage Difference||12.9|5.6|<0.001
72334663|NCT05425732|144192131|SUPERIORITY|A conclusion of superiority is based on the lower bound of the 95% CI for the difference \[V116 - PCV20\] between the percentages of participants with a ≥4-fold rise from baseline being \>10 percentage points (one-sided p-value \< 0.025).|Percent Difference|51.1|||<|0.001|TWO_SIDED|95.0|47.1|54.9||1-sided|Stratified Miettinen & Nurminen||V116 minus PCV20|Serotype 16F: V116-PCV20 Percentage Difference||54.9|47.1|<0.001
72334664|NCT05425732|144192131|SUPERIORITY|A conclusion of superiority is based on the lower bound of the 95% CI for the difference \[V116 - PCV20\] between the percentages of participants with a ≥4-fold rise from baseline being \>10 percentage points (one-sided p-value \< 0.025).|Percent Difference|66.3|||<|0.001|TWO_SIDED|95.0|62.8|69.6||1-sided|Stratified Miettinen & Nurminen||V116 minus PCV20|Serotype 17F: V116-PCV20 Percentage Difference||69.6|62.8|<0.001
72334665|NCT05425732|144192131|SUPERIORITY|A conclusion of superiority is based on the lower bound of the 95% CI for the difference \[V116 - PCV20\] between the percentages of participants with a ≥4-fold rise from baseline being \>10 percentage points (one-sided p-value \< 0.025).|Percent Difference|57.7|||<|0.001|TWO_SIDED|95.0|54.2|61.1||1-sided|Stratified Miettinen & Nurminen||V116 minus PCV20|Serotype 20A: V116-PCV20 Percentage Difference||61.1|54.2|<0.001
72334666|NCT05425732|144192131|SUPERIORITY|A conclusion of superiority is based on the lower bound of the 95% CI for the difference \[V116 - PCV20\] between the percentages of participants with a ≥4-fold rise from baseline being \>10 percentage points (one-sided p-value \< 0.025).|Percent Difference|42.2|||<|0.001|TWO_SIDED|95.0|37.6|46.6||1-sided|Stratified Miettinen & Nurminen||V116 minus PCV20|Serotype 23A: V116-PCV20 Percentage Difference||46.6|37.6|<0.001
72334667|NCT05425732|144192131|SUPERIORITY|A conclusion of superiority is based on the lower bound of the 95% CI for the difference \[V116 - PCV20\] between the percentages of participants with a ≥4-fold rise from baseline being \>10 percentage points (one-sided p-value \< 0.025).|Percent Difference|35.9|||<|0.001|TWO_SIDED|95.0|32.1|39.6||1-sided|Stratified Miettinen & Nurminen||V116 minus PCV20|Serotype 23B: V116-PCV20 Percentage Difference||39.6|32.1|<0.001
72334668|NCT05425732|144192131|SUPERIORITY|A conclusion of superiority is based on the lower bound of the 95% CI for the difference \[V116 - PCV20\] between the percentages of participants with a ≥4-fold rise from baseline being \>10 percentage points (one-sided p-value \< 0.025).|Percent Difference|74.2|||<|0.001|TWO_SIDED|95.0|71.1|77.1||1-sided|Stratified Miettinen & Nurminen||V116 minus PCV20|Serotype24F: V116-PCV20 Percentage Difference||77.1|71.1|<0.001
72334669|NCT05425732|144192131|SUPERIORITY|A conclusion of superiority is based on the lower bound of the 95% CI for the difference \[V116 - PCV20\] between the percentages of participants with a ≥4-fold rise from baseline being \>10 percentage points (one-sided p-value \< 0.025).|Percent Difference|58.6|||<|0.001|TWO_SIDED|95.0|54.8|62.1||1-sided|Stratified Miettinen & Nurminen||V116 minus PCV20|Serotype 31: V116-PCV20 Percentage Difference||62.1|54.8|<0.001
72425506|NCT03661996|144362533|SUPERIORITY|A within-group analysis of change at Week 8 from baseline.|Least Squares Mean Change From Baseline|24.8|STANDARD_ERROR_OF_MEAN|1.598|<|0.0001|TWO_SIDED|95.0|21.66|27.94|||Mixed Models Analysis|LS means, 95% CIs, and P values were obtained from a mixed model for repeated measures (MMRM)||Results are summarized by subject type and the injected knee. The KOOS subscale scores are derived and normalized. Higher scores indicate improvement. Model terms included pooled site group, baseline K-L grade category, baseline BMI category, sex, study visit, and baseline subscale score as covariates.||27.94|21.66|<0.0001
72425507|NCT03661996|144362534|SUPERIORITY|A within-group analysis of change at Week 8 from baseline.|Least Squares Mean Change From Baseline|22.1|STANDARD_ERROR_OF_MEAN|1.898|<|0.0001|TWO_SIDED|95.0|18.37|25.84|||Mixed Models Analysis|LS means, 95% CIs, and P values were obtained from a mixed model for repeated measures (MMRM)||Results are summarized by subject type and the injected knee. The KOOS subscale scores are derived and normalized. Higher scores indicate improvement. Model terms included pooled site group, baseline K-L grade category, baseline BMI category, sex, study visit, and baseline subscale score as covariates.||25.84|18.37|<0.0001
72425508|NCT03661996|144362534|SUPERIORITY|A within-group analysis of change at Week 8 from baseline.|Least Squares Mean Change From Baseline|16.75|STANDARD_ERROR_OF_MEAN|6.255|<|0.0001|TWO_SIDED|95.0|3.84|29.66|||Mixed Models Analysis|LS means, 95% CIs, and P values were obtained from a mixed model for repeated measures (MMRM)||Results are summarized by subject type and the injected knee. The KOOS subscale scores are derived and normalized. Higher scores indicate improvement. Model terms included pooled site group, baseline K-L grade category, baseline BMI category, sex, study visit, and baseline subscale score as covariates.||29.66|3.84|<0.0001
72425509|NCT03661996|144362534|SUPERIORITY|A within-group analysis of change at Week 8 from baseline.|Least Squares Mean Change From Baseline|21.52|STANDARD_ERROR_OF_MEAN|1.062|<|0.0001|TWO_SIDED|95.0|19.43|23.6|||Mixed Models Analysis|LS means, 95% CIs, and P values were obtained from a mixed model for repeated measures (MMRM)||Results are summarized by subject type and the injected knee. The KOOS subscale scores are derived and normalized. Higher scores indicate improvement. Model terms included pooled site group, baseline K-L grade category, baseline BMI category, sex, study visit, and baseline subscale score as covariates.||23.60|19.43|<0.0001
72425510|NCT03661996|144362534|SUPERIORITY|A within-group analysis of change at Week 8 from baseline.|Least Squares Mean Change From Baseline|19.4|STANDARD_ERROR_OF_MEAN|1.365|<|0.0001|TWO_SIDED|95.0|16.72|22.09|||Mixed Models Analysis|LS means, 95% CIs, and P values were obtained from a mixed model for repeated measures (MMRM)||Results are summarized by subject type and the injected knee. The KOOS subscale scores are derived and normalized. Higher scores indicate improvement. Model terms included pooled site group, baseline K-L grade category, baseline BMI category, sex, study visit, and baseline subscale score as covariates.||22.09|16.72|<0.0001
72425511|NCT03661996|144362535|SUPERIORITY|A within-group analysis of change at Week 8 from baseline.|Least Squares Mean Change From Baseline|-3.48|STANDARD_ERROR_OF_MEAN|0.191|<|0.0001|TWO_SIDED|95.0|-3.86|-3.1|||Mixed Models Analysis|LS means, 95% CIs, and P values were obtained from a mixed model for repeated measures (MMRM)||Results are summarized by subject type and the injected knee. The NPRS was collected during the last study visit. Lower scores indicate improvement. Model terms included pooled site group, baseline K-L grade category, baseline BMI category, sex, study visit, and baseline pain score as covariates.||-3.10|-3.86|<0.0001
72425512|NCT03661996|144362535|SUPERIORITY|A within-group analysis of change at Week 8 from baseline.|Least Squares Mean Change From Baseline|-3.52|STANDARD_ERROR_OF_MEAN|0.416|<|0.0001|TWO_SIDED|95.0|-4.38|-2.67|||Mixed Models Analysis|LS means, 95% CIs, and P values were obtained from a mixed model for repeated measures (MMRM)||Results are summarized by subject type and the injected knee. The NPRS was collected during the last study visit. Lower scores indicate improvement. Model terms included pooled site group, baseline K-L grade category, baseline BMI category, sex, study visit, and baseline pain score as covariates.||-2.67|-4.38|<0.0001
72425513|NCT03661996|144362535|SUPERIORITY|A within-group analysis of change at Week 8 from baseline.|Least Squares Mean Change From Baseline|-4.02|STANDARD_ERROR_OF_MEAN|0.118|<|0.0001|TWO_SIDED|95.0|-4.25|-3.79|||Mixed Models Analysis|LS means, 95% CIs, and P values were obtained from a mixed model for repeated measures (MMRM)||Results are summarized by subject type and the injected knee. The NPRS was collected during the last study visit. Lower scores indicate improvement. Model terms included pooled site group, baseline K-L grade category, baseline BMI category, sex, study visit, and baseline pain score as covariates.||-3.79|-4.25|<0.0001
72425514|NCT03661996|144362535|SUPERIORITY|A within-group analysis of change at Week 8 from baseline.|Least Squares Mean Change From Baseline|-3.72|STANDARD_ERROR_OF_MEAN|0.122|<|0.0001|TWO_SIDED|95.0|-3.96|-3.48|||Mixed Models Analysis|LS means, 95% CIs, and P values were obtained from a mixed model for repeated measures (MMRM)||Results are summarized by subject type and the injected knee. The NPRS was collected during the last study visit. Lower scores indicate improvement. Model terms included pooled site group, baseline K-L grade category, baseline BMI category, sex, study visit, and baseline pain score as covariates.||-3.48|-3.96|<0.0001
72334670|NCT05425732|144192131|SUPERIORITY|A conclusion of superiority is based on the lower bound of the 95% CI for the difference \[V116 - PCV20\] between the percentages of participants with a ≥4-fold rise from baseline being \>10 percentage points (one-sided p-value \< 0.025).|Percent Difference|53.2|||<|0.001|TWO_SIDED|95.0|49.6|56.6||1-sided|Stratified Miettinen & Nurminen||V116 minus PCV20|Serotype35B: V116-PCV20 Percentage Difference||56.6|49.6|<0.001
72334671|NCT05425732|144192132|OTHER|A conclusion of immunobridging is based on the lower bound of the 95% CI for the estimated GMT ratio (V116 18-49 Years/V116 50-64 Years) being \> 0.5 (one-sided p-value \< 0.025).|GMT Ratio|1.09|||<|0.001|TWO_SIDED|95.0|0.9|1.33||1-sided|LDA model||V116 18-49 years/V116 50-64 years|Serotype 3: V116 18-49 years/V116 50-64 years GMT Ratio||1.33|0.90|<0.001
72334672|NCT05425732|144192132|OTHER|A conclusion of immunobridging is based on the lower bound of the 95% CI for the estimated GMT ratio (V116 18-49 Years/V116 50-64 Years) being \> 0.5 (one-sided p-value \< 0.025).|GMT Ratio|2.06|||<|0.001|TWO_SIDED|95.0|1.61|2.62||1-sided|LDA model||V116 18-49 years/V116 50-64 years|Serotype 6A: V116 18-49 years/V116 50-64 years GMT Ratio||2.62|1.61|<0.001
72334673|NCT05425732|144192132|OTHER|A conclusion of immunobridging is based on the lower bound of the 95% CI for the estimated GMT ratio (V116 18-49 Years/V116 50-64 Years) being \> 0.5 (one-sided p-value \< 0.025).|GMT Ratio|1.51|||<|0.001|TWO_SIDED|5.0|1.23|1.84||1-sided|LDA model||V116 18-49 years/V116 50-64 years|Serotype 7F: V116 18-49 years/V116 50-64 years GMT Ratio||1.84|1.23|<0.001
72425515|NCT00584701|144362575|SUPERIORITY_OR_OTHER||Dfiference in exon expression|1.5|||<|0.001||||||"Expression difference \>\|1.5\| with p-value adjusted for multiple comparisons."|ANCOVA|Between-group gene expression profiles compared between high versus low responders, controlling for age, gender and batch.||||||<.001
72334674|NCT05425732|144192132|OTHER|A conclusion of immunobridging is based on the lower bound of the 95% CI for the estimated GMT ratio (V116 18-49 Years/V116 50-64 Years) being \> 0.5 (one-sided p-value \< 0.025).|GMT Ratio|1.5|||<|0.001|TWO_SIDED|95.0|1.26|1.79||1-sided|LDA model||V116 18-49 years/V116 50-64 years|Serotype 8: V116 18-49 years/V116 50-64 years GMT Ratio||1.79|1.26|<0.001
72425516|NCT01928225|144362616|SUPERIORITY||Risk Ratio (RR)|1.18||||0.29|TWO_SIDED|95.0|0.87|1.6||\<0.05 was considered statistically significant.|Chi-squared|||||1.6|.87|.29
72425517|NCT01928225|144362617|SUPERIORITY||Risk Ratio (RR)|1.26||||0.22|TWO_SIDED|95.0|0.85|1.95|||Chi-squared|||||1.95|.85|.22
72425518|NCT02265224|144362618|EQUIVALENCE|The statistical analysis took into account treatment, period, sequence and subject (sequence) as sources of variation. Acceptance criterion for bioequivalence was that the 94.12% confidence interval for the ratio between test and reference of the geometric means of the parameters under consideration fell within the 80.00-125.00% range, according to the current guidelines for bioequivalence studies and to the Pocock α spending function.|Geometric means ratio|89.81||||0.0136|TWO_SIDED|94.12|82.82|97.4||p value for treatment effect|ANOVA|||||97.40|82.82|0.0136
72425519|NCT02265224|144362619|EQUIVALENCE|The statistical analysis took into account treatment, period, sequence and subject (sequence) as sources of variation. Acceptance criterion for bioequivalence was that the 94.12% confidence interval for the ratio between test and reference of the geometric means of the parameters under consideration fell within the 80.00-125.00% range, according to the current guidelines for bioequivalence studies and to the Pocock α spending function.|Geometric means ratio|90.79||||0.0047|TWO_SIDED|94.12|85.25|96.69|||ANOVA|p value for treatment effect||||96.69|85.25|0.0047
72425520|NCT02265224|144362620|EQUIVALENCE|The statistical analysis took into account treatment, period, sequence and subject (sequence) as sources of variation. Acceptance criterion for bioequivalence was that the 94.12% confidence interval for the ratio between test and reference of the geometric means of the parameters under consideration fell within the 80.00-125.00% range, according to the current guidelines for bioequivalence studies and to the Pocock α spending function.|Geometric means ratio|91.86||||0.0095|TWO_SIDED|94.12|86.45|97.61||p value for treatment effect|ANOVA|||||97.61|86.45|0.0095
72425521|NCT02265224|144362621|EQUIVALENCE|The statistical analysis took into account treatment, period, sequence and subject (sequence) as sources of variation. Acceptance criterion for bioequivalence was that the 94.12% confidence interval for the ratio between test and reference of the geometric means of the parameters under consideration fell within the 80.00-125.00% range, according to the current guidelines for bioequivalence studies and to the Pocock α spending function.||||||0.505|||||||Friedman test|||||||0.5050
72334675|NCT05425732|144192132|OTHER|A conclusion of immunobridging is based on the lower bound of the 95% CI for the estimated GMT ratio (V116 18-49 Years/V116 50-64 Years) being \> 0.5 (one-sided p-value \< 0.025).|GMT Ratio|1.97|||<|0.001|TWO_SIDED|95.0|1.59|2.43||1-sided|LDA model||V116 18-49 years/V116 50-64 years|Serotype 9N: V116 18-49 years/V116 50-64 years GMT Ratio||2.43|1.59|<0.001
72334676|NCT05425732|144192132|OTHER|A conclusion of immunobridging is based on the lower bound of the 95% CI for the estimated GMT ratio (V116 18-49 Years/V116 50-64 Years) being \> 0.5 (one-sided p-value \< 0.025).|GMT Ratio|1.55|||<|0.001|TWO_SIDED|95.0|1.26|1.92||1-sided|LDA model||V116 18-49 years/V116 50-64 years|Serotype 10A: V116 18-49 years/V116 50-64 years GMT Ratio||1.92|1.26|<0.001
72334677|NCT05425732|144192132|OTHER|A conclusion of immunobridging is based on the lower bound of the 95% CI for the estimated GMT ratio (V116 18-49 Years/V116 50-64 Years) being \> 0.5 (one-sided p-value \< 0.025).|GMT Ratio|1.55|||<|0.001|TWO_SIDED|95.0|1.26|1.91||1-sided|LDA model||V116 18-49 years/V116 50-64 years|Serotype 11A: V116 18-49 years/V116 50-64 years GMT Ratio||1.91|1.26|<0.001
72334678|NCT05425732|144192132|OTHER|A conclusion of immunobridging is based on the lower bound of the 95% CI for the estimated GMT ratio (V116 18-49 Years/V116 50-64 Years) being \> 0.5 (one-sided p-value \< 0.025).|GMT Ratio|1.73|||<|0.001|TWO_SIDED|95.0|1.37|2.17||1-sided|LDA model||V116 18-49 years/V116 50-64 years|Serotype 12F: V116 18-49 years/V116 50-64 years GMT Ratio||2.17|1.37|<0.001
72334679|NCT05425732|144192132|OTHER|A conclusion of immunobridging is based on the lower bound of the 95% CI for the estimated GMT ratio (V116 18-49 Years/V116 50-64 Years) being \> 0.5 (one-sided p-value \< 0.025).|GMT Ratio|1.92|||<|0.001|TWO_SIDED|95.0|1.55|2.37||1-sided|LDA model||V116 18-49 years/V116 50-64 years|Serotype 15A: V116 18-49 years/V116 50-64 years GMT Ratio||2.37|1.55|<0.001
72334680|NCT05425732|144192132|OTHER|A conclusion of immunobridging is based on the lower bound of the 95% CI for the estimated GMT ratio (V116 18-49 Years/V116 50-64 Years) being \> 0.5 (one-sided p-value \< 0.025).|GMT Ratio|1.79|||<|0.001|TWO_SIDED|95.0|1.36|2.35||1-sided|LDA model||V116 18-49 years/V116 50-64 years|Serotype 15C: V116 18-49 years/V116 50-64 years GMT Ratio||2.35|1.36|<0.001
72334681|NCT05425732|144192132|OTHER|A conclusion of immunobridging is based on the lower bound of the 95% CI for the estimated GMT ratio (V116 18-49 Years/V116 50-64 Years) being \> 0.5 (one-sided p-value \< 0.025).|GMT Ratio|1.55|||<|0.001|TWO_SIDED|95.0|1.26|1.91||1-sided|LDA model||V116 18-49 years/V116 50-64 years|Serotype 16F: V116 18-49 years/V116 50-64 years GMT Ratio||1.91|1.26|<0.001
72334682|NCT05425732|144192132|OTHER|A conclusion of immunobridging is based on the lower bound of the 95% CI for the estimated GMT ratio (V116 18-49 Years/V116 50-64 Years) being \> 0.5 (one-sided p-value \< 0.025).|GMT Ratio|1.6|||<|0.001|TWO_SIDED|95.0|1.26|2.02||1-sided|LDA model||V116 18-49 years/V116 50-64 years|Serotype 17F: V116 18-49 years/V116 50-64 years GMT Ratio||2.02|1.26|<0.001
72334683|NCT05425732|144192132|OTHER|A conclusion of immunobridging is based on the lower bound of the 95% CI for the estimated GMT ratio (V116 18-49 Years/V116 50-64 Years) being \> 0.5 (one-sided p-value \< 0.025).|GMT Ratio|1.17|||<|0.001|TWO_SIDED|95.0|0.97|1.4||1-sided|LDA model||V116 18-49 years/V116 50-64 years|Serotype 19A: V116 18-49 years/V116 50-64 years GMT Ratio||1.40|0.97|<0.001
72334684|NCT05425732|144192132|OTHER|A conclusion of immunobridging is based on the lower bound of the 95% CI for the estimated GMT ratio (V116 18-49 Years/V116 50-64 Years) being \> 0.5 (one-sided p-value \< 0.025).|GMT Ratio|1.74|||<|0.001|TWO_SIDED|95.0|1.39|2.18||1-sided|LDA model||V116 18-49 years/V116 50-64 years|Serotype 20A: V116 18-49 years/V116 50-64 years GMT Ratio||2.18|1.39|<0.001
72334685|NCT05425732|144192132|OTHER|A conclusion of immunobridging is based on the lower bound of the 95% CI for the estimated GMT ratio (V116 18-49 Years/V116 50-64 Years) being \> 0.5 (one-sided p-value \< 0.025).|GMT Ratio|1.99|||<|0.001|TWO_SIDED|95.0|1.58|2.49||1-sided|LDA model||V116 18-49 years/V116 50-64 years|Serotype 22F: V116 18-49 years/V116 50-64 years GMT Ratio||2.49|1.58|<0.001
72425522|NCT01454830|144362642|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.58|STANDARD_ERROR_OF_MEAN|0.44||0.2|TWO_SIDED||||||t-test, 2 sided||unit of measurement, hours/night; positive estimation parameter favors TI group; negative estimation parameter favors UC group|Pilot RCT designed to establish effect size and feasibility outcomes; no a priori power calculation; statistical significance with hypotheses testing was not objective of the pilot trial||||0.20
72425523|NCT01454830|144362643|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.06|STANDARD_ERROR_OF_MEAN|0.48||0.9|TWO_SIDED||||||t-test, 2 sided||unit of measurement: hours/night; positive estimation parameter favors TI group; negative estimation parameter favors UC group|Pilot RCT designed to establish effect size and feasibility outcomes; no a priori power calculation; statistical significance with hypotheses testing was not objective of the pilot trial||||0.90
72425524|NCT01454830|144362644|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.07|STANDARD_ERROR_OF_MEAN|0.53||0.89|TWO_SIDED||||||t-test, 2 sided||units of measurement: hours/night; positive estimation parameter favors TI group; negative estimation parameter favors UC group|Pilot RCT designed to establish effect size and feasibility outcomes; no a priori power calculation; statistical significance with hypotheses testing was not objective of the pilot trial||||0.89
72425525|NCT01454830|144362645|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.15|STANDARD_ERROR_OF_MEAN|4.09||0.78|TWO_SIDED||||||t-test, 2 sided||units of measurement: % TST; positive estimation parameter favors TI group; negative estimation parameter favors UC group|Exploratory outcome of PAP use defined within the sleep period, TST (total sleep time).||||0.78
72425526|NCT02006420|144362649|SUPERIORITY|||||||0.005|||||||t-test, 2 sided|Unequal variance assumption||This is the p value for the mean skin thickness of the forearm.||||0.005
72425527|NCT02006420|144362649|SUPERIORITY|||||||0.71|||||||t-test, 2 sided|Unequal variance assumption||This is the p value for the mean skin stiffness of the thigh||||0.71
72425528|NCT02006420|144362650|SUPERIORITY|||||||0.002|||||||Pearson correlation|||This is the p-value for the forearm||||0.002
72425529|NCT02006420|144362650|SUPERIORITY|||||||0.007|||||||Pearson correlation|||This is the p-value for the thigh||||0.007
72425530|NCT02006420|144362651|SUPERIORITY|||||||0.002|||||||Pearson correlation|||This is the p value for the forearm.||||0.002
72425531|NCT02006420|144362651|SUPERIORITY|||||||0.007|||||||Pearson correlation|||This is the p value for the thigh||||0.007
72425532|NCT02006420|144362653|SUPERIORITY||||||<|0.0001|||||||Pearson correlation|||This is the p-value for the forearm||||<.0001
72425533|NCT02006420|144362653|SUPERIORITY||||||<|0.0001|||||||Pearson correlation|||This is the p-value for the thigh||||<0.0001
72425534|NCT02006420|144362655|SUPERIORITY|||||||0.01|||||||Pearson correlation|||This is the p-value for the forearm||||0.01
72425535|NCT02006420|144362655|SUPERIORITY|||||||0.1|||||||Pearson correlation|||This is the p-value for the thigh||||0.10
72425536|NCT01965158|144362657|SUPERIORITY_OR_OTHER||Difference|13.0|STANDARD_ERROR_OF_MEAN|4.19||0.002|TWO_SIDED|95.0|4.8|21.3||To control the overall type I error rate to be ≤ 0.05 for the primary and secondary efficacy endpoints, a fixed-sequence (hierarchical) testing approach was applied.|Cochran-Mantel-Haenszel|P-value was calculated by Cochran-Mantel-Haenszel test adjusted by the opioid dose strata.||||21.3|4.8|0.0020
72425537|NCT01965158|144362658|SUPERIORITY_OR_OTHER||LS Mean Difference|1.3|STANDARD_ERROR_OF_MEAN|0.271|<|0.0001|TWO_SIDED|95.0|0.77|1.83|||ANCOVA|The ANCOVA model has the terms for treatment group as a fixed effect and the opioid dose strata as a covariate.||||1.83|0.77|<0.0001
72425538|NCT01965158|144362659|SUPERIORITY_OR_OTHER||LS Mean Difference|2.11|STANDARD_ERROR_OF_MEAN|0.26|<|0.0001|TWO_SIDED|95.0|1.6|2.63|||ANCOVA|The ANCOVA model has the terms for treatment group as a fixed effect and the opioid dose strata as a covariate.||||2.63|1.60|<0.0001
72425539|NCT01965158|144362660|SUPERIORITY_OR_OTHER||LS Mean Difference|1.01|STANDARD_ERROR_OF_MEAN|0.24|<|0.0001|TWO_SIDED|95.0|0.54|1.48|||ANCOVA|ANCOVA model has the terms for treatment group as a fixed effect and the opioid dose strata as a covariate.||||1.48|0.54|<0.0001
72425540|NCT01965158|144362661|SUPERIORITY_OR_OTHER||LS Mean Difference|0.73|STANDARD_ERROR_OF_MEAN|0.198||0.0003|TWO_SIDED|95.0|0.34|1.12|||ANCOVA|The ANCOVA model has the terms for treatment group as a fixed effect and the opioid dose strata as a covariate.||||1.12|0.34|0.0003
72425541|NCT02006121|144362666|SUPERIORITY|||||||0.0047|||||||Mixed Models Analysis|||||||0.0047
72425542|NCT02006121|144362667|SUPERIORITY|||||||0.0022|||||||Mixed Models Analysis|||||||0.0022
72425543|NCT02006121|144362668|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
72425544|NCT02006121|144362669|SUPERIORITY|||||||0.005|||||||Mixed Models Analysis|||||||0.005
72425545|NCT02006121|144362670|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||||||<0.0001
72425546|NCT02693834|144362671|OTHER|Paired t test||||||0.293|||||||t-test, 2 sided|||In order to test the difference in gait endurance,between the two AFO conditions at baseline, a paired t-test was analyzed||||.293
72425547|NCT02693834|144362672|OTHER|Repeated measures ANOVA||||||0.077||||||The above value was the interaction between the type of AFO and practice time.|repeated measures ANOVA|||A repeated measures ANOVA was calculated to find the differences in gait endurance between the type of AFO and practice time.||||0.077
72425548|NCT02693834|144362672|OTHER|Repeated measures ANOVA||||||0.046||||||main effect of the type of AFO: F(1, 19) = 4.58, ηp2= .194|repeated measures ANOVA|||The main effect of type of AFO||||.046
72425549|NCT02693834|144362672|OTHER|Repeated measures ANOVA|||||<|0.001||||||main effect of practice: F(1, 19) = 43.94, ηp2 = .698|repeated measures ANOVA|||Main effect of practice||||<.001
72425550|NCT02693834|144362673|OTHER|paired t test||||||0.688|||||||t-test, 2 sided|||The significance of differences in gait symmetry, between the two AFO conditions at baseline were analyzed using a paired t test for self selected velocity||||.688
72425551|NCT02693834|144362673|OTHER|repeated measures MANOVA||||||0.397||||||The above p value is for the interaction effects between type of AFO and practice time for gait symmetry at the self selected velocity F(1, 19)= 0.75, ηp2 = .038|repeated measures MANOVA|||The significance of differences in gait symmetry at self select velocity, between the two AFO conditions and two practice conditions were analyzed using repeated measures MANOVA.||||.397
72425552|NCT02693834|144362673|OTHER|A repeated measures MANOVA||||||0.95||||||Main effect of AFO on gait symmetry at SSV: F(1, 19) = 0.004, ηp2 =.00|Repeated measures MANOVA|||Main effect of AFO on gait symmetry was analyzed at self selected velocity||||.950
72425553|NCT02693834|144362673|OTHER|Repeated measures MANOVA||||||0.111||||||The main effect of practice on gait symmetry at self selected velocity F(1, 19) = 2.79, ηp2 = .128|repeated measures MANOVA|||Main effect of practice on gait symmetry at Self selected velocity||||.111
72425554|NCT02693834|144362673|OTHER|||||||0.26|||||||t-test, 2 sided|||The significance of differences in gait symmetry, between the two AFO conditions at baseline were analyzed using a paired t test for fast paced velocity||||.260
72425555|NCT02693834|144362673|OTHER|repeated measures MANOVA||||||0.113||||||The above p value is for the interaction effects between type of AFO and practice time for gait symmetry at fast paced velocity FPV F(1, 19) = 2.76,, ηp2 = .127|repeated measures MANOVA|||The significance of differences in gait symmetry at fast paced velocity, between the two AFO conditions and two practice conditions were analyzed using repeated measures MANOVA||||.113
72425556|NCT02693834|144362673|OTHER|Repeated measures MANOVA||||||0.918||||||The main effect of AFO on gait symmetry at fast paced velocity: F(1, 19) = 0.01, ηp2 = 0.001|repeated measures MANOVA|||The main effect of AFO on gait symmetry at fast paced velocity walk was assessed with repeated measures MANOVA||||.918
72425557|NCT02693834|144362673|OTHER|Repeated measures MANOVA||||||0.077||||||The main effect of practice on gait symmetry at fast paced velocity: F(1, 19) = 3.50, ηp2 = .155|repeated measures MANOVA|||The main effect of practice on gait symmetry at fast paced velocity walk was assessed with repeated measures MANOVA||||.077
72425558|NCT02693834|144362674|OTHER|A repeated measures MANOVA||||||0.209||||||The above p value is for the interaction effects between the type of AFO and practice time at self selected velocity: F(1, 19) = 1.69, ηp2 = .082|Repeated measures MANOVA|||The significance of differences in gait velocity at self select velocity, between the two AFO conditions and two practice conditions were analyzed using repeated measures MANOVA.||||.209
72425559|NCT02693834|144362674|OTHER|Repeated measures MANOVA||||||0.32||||||Main effect of AFO on gait velocity at self selected velocity: F(1, 19) = 1.05, ηp2 = .05|repeated measures MANOVA|||Main effect of AFO on gait velocity was analyzed at self selected velocity||||.32
72425560|NCT02693834|144362674|OTHER|Repeated measures MANOVA||||||0.001||||||Main effect of practice on gait velocity at self selected velocity:F(1, 19) = 14.38, ηp2 = .431|repeated measures MANOVA|||Main effect of Practice on gait velocity was analyzed at self selected velocity||||.001
72425561|NCT02693834|144362674|OTHER|repeated measures MANOVA||||||0.28||||||The above p value is for the interaction effects between the type of AFO and practice time at fast paced velocity: F( 1, 19) = 1.24, ηp2 = .61|repeated measures MANOVA|||The significance of differences in gait velocity at fast paced velocity, between the two AFO conditions and two practice conditions were analyzed using repeated measures MANOVA.||||.280
72425562|NCT02693834|144362674|OTHER|repeated measures MANOVA||||||0.072||||||Main effect of AFO on gait velocity was analyzed at self selected velocity:FPV F(1, 19) = 3.63, ηp2 =.16|repeated measures MANOVA|||Main effect of AFO on gait velocity was analyzed for self selected velocity||||.072
72425563|NCT02693834|144362674|OTHER|Repeated measures MANOVA|||||<|0.001||||||Main effect of Practice on gait velocity for fast paced velocity: F(1, 19) = 23.73, ηp2 = .555|repeated measures MANOVA|||Main effect of Practice on gait velocity was analyzed for fast paced velocity||||<.001
72334686|NCT05425732|144192132|OTHER|A conclusion of immunobridging is based on the lower bound of the 95% CI for the estimated GMT ratio (V116 18-49 Years/V116 50-64 Years) being \> 0.5 (one-sided p-value \< 0.025).|GMT Ratio|1.87|||<|0.001|TWO_SIDED|95.0|1.43|2.44||1-sided|LDA model||V116 18-49 years/V116 50-64 years|Serotype 23A: V116 18-49 years/V116 50-64 years GMT Ratio||2.44|1.43|<0.001
72334687|NCT05425732|144192132|OTHER|A conclusion of immunobridging is based on the lower bound of the 95% CI for the estimated GMT ratio (V116 18-49 Years/V116 50-64 Years) being \> 0.5 (one-sided p-value \< 0.025).|GMT Ratio|1.51|||<|0.001|TWO_SIDED|95.0|1.11|2.04||1-sided|LDA model||V116 18-49 years/V116 50-64 years|Serotype 23B: V116 18-49 years/V116 50-64 years GMT Ratio||2.04|1.11|<0.001
72334688|NCT05425732|144192132|OTHER|A conclusion of immunobridging is based on the lower bound of the 95% CI for the estimated GMT ratio (V116 18-49 Years/V116 50-64 Years) being \> 0.5 (one-sided p-value \< 0.025).|GMT Ratio|1.36|||<|0.001|TWO_SIDED|95.0|1.1|1.67||1-sided|LDA model||V116 18-49 years/V116 50-64 years|Serotype 24F: V116 18-49 years/V116 50-64 years GMT Ratio||1.67|1.10|<0.001
72334689|NCT05425732|144192132|OTHER|A conclusion of immunobridging is based on the lower bound of the 95% CI for the estimated GMT ratio (V116 18-49 Years/V116 50-64 Years) being \> 0.5 (one-sided p-value \< 0.025).|GMT Ratio|2.1|||<|0.001|TWO_SIDED|95.0|1.63|2.69||1-sided|LDA model||V116 18-49 years/V116 50-64 years|Serotype 31: V116 18-49 years/V116 50-64 years GMT Ratio||2.69|1.63|<0.001
72334690|NCT05425732|144192132|OTHER|A conclusion of immunobridging is based on the lower bound of the 95% CI for the estimated GMT ratio (V116 18-49 Years/V116 50-64 Years) being \> 0.5 (one-sided p-value \< 0.025).|GMT Ratio|1.98|||<|0.001|TWO_SIDED|95.0|1.52|2.57||1-sided|LDA model||V116 18-49 years/V116 50-64 years|Serotype 33F: V116 18-49 years/V116 50-64 years GMT Ratio||2.57|1.52|<0.001
72334691|NCT05425732|144192132|OTHER|A conclusion of immunobridging is based on the lower bound of the 95% CI for the estimated GMT ratio (V116 18-49 Years/V116 50-64 Years) being \> 0.5 (one-sided p-value \< 0.025).|GMT Ratio|1.54|||<|0.001|TWO_SIDED|95.0|1.26|1.87||1-sided|LDA model||V116 18-49 years/V116 50-64 years|Serotype 35B: V116 18-49 years/V116 50-64 years GMT Ratio||1.87|1.26|<0.001
72334692|NCT05425732|144192133|OTHER|"A conclusion of acceptability is based on the lower bound of the 95% CI of the percentages of participants with a~≥4-fold rise from baseline to 30 days postvaccination being \> 50 percentage points (one-sided p-value \< 0.025)."||||||0.667||||||1-sided|Clopper-Pearson method.|||Serotype 6C||||0.667
72334693|NCT05425732|144192133|OTHER|"A conclusion of acceptability is based on the lower bound of the 95% CI of the percentages of participants with a~≥4-fold rise from baseline to 30 days postvaccination being \> 50 percentage points (one-sided p-value \< 0.025)."|||||<|0.001||||||1-sided|Clopper-Pearson method.|||Serotype 15B||||<0.001
72334694|NCT05425732|144192134|OTHER|A conclusion of immunobridging is based on the lower bound of the 95% CI for the estimated GMT ratio (V116 18-49 Years/V116 50-64 Years) being \> 0.5 (one-sided p-value \< 0.025).|GMT Ratio|2.05|||||TWO_SIDED|95.0|1.52|2.77|||||V116 18-49 years/V116 50-64 years|Serotype 6C: V116 18-49 years/V116 50-64 years GMT Ratio||2.77|1.52|
72334695|NCT05425732|144192134|OTHER|A conclusion of immunobridging is based on the lower bound of the 95% CI for the estimated GMT ratio (V116 18-49 Years/V116 50-64 Years) being \> 0.5 (one-sided p-value \< 0.025).|GMT|2.02|||<|0.001|TWO_SIDED|95.0|1.57|2.6||1-sided|LDA model||V116 18-49 years/V116 50-64 years|Serotype 15B: V116 18-49 years/V116 50-64 years GMT ratio||2.60|1.57|<0.001
72334696|NCT05425732|144192135|OTHER|cLDA model|GMC Ratio|1.47|||||TWO_SIDED|95.0|1.35|1.6|||||V116/PCV20|Serotype 3: V116/PCV20 GMC Ratio||1.60|1.35|
72334697|NCT05425732|144192135|OTHER|cLDA model|GMC Ratio|0.79|||||TWO_SIDED|95.0|0.7|0.89|||||V116/PCV20|Serotype 6A: V116/PCV20 GMC Ratio||0.89|0.70|
72334698|NCT05425732|144192135|OTHER|cLDA model|GMC Ratio|1.06|||||TWO_SIDED|95.0|0.95|1.18|||||V116/PCV20|Serotype 7F: V116/PCV20 GMC Ratio||1.18|0.95|
72334699|NCT05425732|144192135|OTHER|cLDA model|GMC Ratio|1.43|||||TWO_SIDED|95.0|1.29|1.59|||||V116/PCV20|Serotype 8: V116/PCV20 GMC Ratio||1.59|1.29|
72334700|NCT05425732|144192135|OTHER|cLDA model|GMC Ratio|0.82|||||TWO_SIDED|95.0|0.72|0.92|||||V116/PCV20|Serotype 10A: V116/PCV20 GMC Ratio||0.92|0.72|
72334701|NCT05425732|144192135|OTHER|cLDA model|GMC Ratio|1.23|||||TWO_SIDED|95.0|1.11|1.36|||||V116/PCV20|Serotype 11A: V116/PCV20 GMC Ratio||1.36|1.11|
72334702|NCT05425732|144192135|OTHER|cLDA model|GMC Ratio|1.1|||||TWO_SIDED|95.0|0.96|1.26|||||V116/PCV20|Serotype 12F: V116/PCV20 GMC Ratio||1.26|0.96|
72334703|NCT05425732|144192135|OTHER|cLDA model|GMC Ratio|0.7|||||TWO_SIDED|95.0|0.63|0.77|||||V116/PCV20|Serotype 19A: V116/PCV20 GMC Ratio||0.77|0.63|
72334704|NCT05425732|144192135|OTHER|cLDA model|GMC Ratio|0.8|||||TWO_SIDED|95.0|0.72|0.9|||||V116/PCV20|Serotype 22F: V116/PCV20 GMC Ratio||0.90|0.72|
72334705|NCT05425732|144192135|OTHER|cLDA model|GMC Ratio|1.06|||||TWO_SIDED|95.0|0.95|1.18|||||V116/PCV20|Serotype 33F: V116/PCV20 GMC Ratio||1.18|0.95|
72334706|NCT05425732|144192135|OTHER|cLDA model|GMC Ratio|5.41|||||TWO_SIDED|95.0|4.82|6.06|||||V116/PCV20|Serotype 9N: V116/PCV20 GMC Ratio||6.06|4.82|
72334707|NCT05425732|144192135|OTHER|cLDA model|GMC Ratio|6.79|||||TWO_SIDED|95.0|6.03|7.64|||||V116/PCV20|Serotype 15A: V116/PCV20 GMC Ratio||7.64|6.03|
72334708|NCT05425732|144192135|OTHER|cLDA model|GMC Ratio|2.46|||||TWO_SIDED|95.0|2.17|2.79|||||V116/PCV20|Serotype 15C: V116/PCV20 GMC Ratio||2.79|2.17|
72334709|NCT05425732|144192135|OTHER|cLDA model|GMC Ratio|8.75|||||TWO_SIDED|95.0|7.95|9.64|||||V116/PCV20|Serotype 16F: V116/PCV20 GMC Ratio||9.64|7.95|
72334710|NCT05425732|144192135|OTHER|cLDA model|GMC Ratio|16.75|||||TWO_SIDED|95.0|15.25|18.41|||||V116/PCV20|Serotype 17F: V116/PCV20 GMC Ratio||18.41|15.25|
72334711|NCT05425732|144192135|OTHER|cLDA model|GMC Ratio|12.92|||||TWO_SIDED|5.0|11.81|14.13|||||V116/PCV20|Serotype 20A: V116/PCV20 GMC Ratio||14.13|11.81|
72334712|NCT05425732|144192135|OTHER|cLDA model|GMC Ratio|6.42|||||TWO_SIDED|95.0|5.69|7.24|||||V116/PCV20|Serotype 23A: V116/PCV20 GMC Ratio||7.24|5.69|
72334713|NCT05425732|144192135|OTHER|cLDA model|GMC Ratio|3.25|||||TWO_SIDED|95.0|2.91|3.64|||||V116/PCV20|Serotype 23B: V116/PCV20 GMC Ratio||3.64|2.91|
72334714|NCT05425732|144192135|OTHER|cLDA model|GMC Ratio|21.08|||||TWO_SIDED|85.0|18.97|23.43|||||V116/PCV20|Serotype 24F: V116/PCV20 GMC Ratio||23.43|18.97|
72334715|NCT05425732|144192135|OTHER|cLDA model|GMC Ratio|11.31|||||TWO_SIDED|95.0|10.36|12.34|||||V116/PCV20|Serotype 31: V116/PCV20 GMC Ratio||12.34|10.36|
72334716|NCT05425732|144192135|OTHER|cLDA model|GMC Ratio|14.13|||||TWO_SIDED|95.0|12.97|15.4|||||V116/PCV20|Serotype 35B: V116/PCV20 GMC Ratio||15.40|12.97|
72334717|NCT02998203|144192143|OTHER|One-sample t-test|||||<|0.001|||||||One-sample t-test|||A one-sample t-test was used to assess whether the percent change was different than zero.||||<0.001
72334718|NCT02998203|144192144|OTHER|non-parametric Wilcoxon rank sum test|||||<|0.001|||||||Wilcoxon rank sum test|||The overall differences in the medians of biomarkers between the conventional and the organic periods were assessed with the non-parametric Wilcoxon rank sum test||||<0.001
72334719|NCT02998203|144192145|OTHER|Linear mixed-effect regression model|||||<|0.001||||||Multiple testing was accounted for using the Benjamini-Hochberg method, considering 58 regression parameter tests of the aforementioned models. Q-value\<0.05 were considered statistically significant (controlling the false discovery rate at 5%).|Mixed Models Analysis|||||||<0.001
72334720|NCT02998203|144192146|OTHER|Wilcoxon rank sum test||||||0.017|||||||Wilcoxon rank sum test|||The overall differences in the medians of biomarkers between the conventional and the organic periods were assessed with the non-parametric Wilcoxon rank sum test||||0.017
72334721|NCT02998203|144192147|OTHER|Logistic mixed-effect model||||||0.014||||||Multiple testing was accounted for using the Benjamini-Hochberg method, considering 58 regression parameter tests of the aforementioned models. Q-value\<0.05 were considered statistically significant (controlling the false discovery rate at 5%).|Mixed Models Analysis|||||||0.014
72334722|NCT02998203|144192148|OTHER|One-sample t-test||||||0.167|||||||One-sample t-test|||A one-sample t-test was used to assess whether the percent change was different than zero.||||0.167
72334723|NCT02998203|144192149|OTHER|Wilcoxon rank sum test||||||0.07|||||||Wilcoxon rank sum test|||The overall differences in the medians of biomarkers between the conventional and the organic periods were assessed with the non-parametric Wilcoxon rank sum test||||0.07
72334724|NCT02998203|144192150|OTHER|Linear mixed-effect regression model||||||0.014||||||Multiple testing was accounted for using the Benjamini-Hochberg method, considering 58 regression parameter tests of the aforementioned models. Q-value\<0.05 were considered statistically significant (controlling the false discovery rate at 5%).|Mixed Models Analysis|||||||0.014
72334725|NCT02998203|144192151|OTHER|One-sample t-test||||||0.023|||||||One-sample t-test|||A one-sample t-test was used to assess whether the percent change was different than zero.||||0.023
72425564|NCT00152971|144362680|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority Analysis with NI margin 9.2% on the absolute risk difference scale|Risk Difference (Percentage)|5.8||||0.0234||95.0|0.8|10.8||Hierarchical testing procedure: first non-inferiority, second superiority|Normal approximation|Normal approximation of independent binomial distribution without stratification||Risk difference versus Enoxaparin||10.8|0.8|0.0234
72334726|NCT02998203|144192152|OTHER|Wilcoxon rank sum test||||||0.259|||||||Wilcoxon rank sum test|||The overall differences in the medians of biomarkers between the conventional and the organic periods were assessed with the non-parametric Wilcoxon rank sum test||||0.259
72334727|NCT02998203|144192153|OTHER|Linear mixed-effect regression model|||||<|0.001||||||Multiple testing was accounted for using the Benjamini-Hochberg method, considering 58 regression parameter tests of the aforementioned models. Q-value\<0.05 were considered statistically significant (controlling the false discovery rate at 5%).|Mixed Models Analysis|||The interaction term for time and treatment was included in the models since it met the threshold of p-value\<0. 05. Specifically, for the interaction term of time and organic treatment b=-0.016, 95% CI=\[-0.023,-0.010\], p-value=\<0.001.||||<0.001
72334728|NCT02998203|144192154|OTHER|One-sample t-test||||||0.913|||||||One-sample t-test|||A one-sample t-test was used to assess whether the percent change was different than zero.||||0.913
72334729|NCT02998203|144192155|OTHER|Wilcoxon rank sum test||||||0.338|||||||Wilcoxon rank sum test|||The overall differences in the medians of biomarkers between the conventional and the organic periods were assessed with the non-parametric Wilcoxon rank sum test||||0.338
72334730|NCT02998203|144192156|OTHER|Linear mixed-effect regression model||||||0.001||||||Multiple testing was accounted for using the Benjamini-Hochberg method, considering 58 regression parameter tests of the aforementioned models. Q-value\<0.05 were considered statistically significant (controlling the false discovery rate at 5%).|Mixed Models Analysis|||The interaction term for time and treatment was included in the models since it met the threshold of p-value\<0. 05. Specifically, for the interaction term of time and organic treatment b=-0.016, 95% CI=\[-0.023,-0.010\], p-value=0.01.||||0.001
72334731|NCT04187144|144192157|NON_INFERIORITY|The difference in success rate between treatment groups (gepotidacin - nitrofurantoin) was calculated using Miettinen-Nurminen Summary Score Method adjusted for age group and acute cystitis recurrence strata combinations. Criteria for non-inferiority is if the Z-statistic for non-inferiority is greater than the 2.098 Z-statistic boundary.|Adjusted Difference in Percent|14.6|||||TWO_SIDED|95.0|6.4|22.8|||||||Observed Z statistic value for Noninferiority was 5.8838.|22.8|6.4|
72334732|NCT04187144|144192157|SUPERIORITY||Adjusted difference in Percent|14.6||||0.0003|TWO_SIDED|95.0|6.4|22.8|||1-sided p-value for Test of Superiority|||The difference in success rate between treatment groups (gepotidacin - nitrofurantoin) was calculated using Miettinen-Nurminen Summary Score Method adjusted for age group and acute cystitis recurrence strata combinations. Criteria for superiority is if the one-sided p-value is less than the 0.018 p-value boundary||22.8|6.4|0.0003
72425565|NCT00152971|144362680|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority Analysis with NI margin 9.2% on the absolute risk difference scale|Risk Difference (Percentage)|8.4||||0.0009||95.0|3.4|13.3||Hierarchical testing procedure: first non-inferiority, second superiority|Normal approximation|Normal approximation of independent binomial distribution without stratification||Risk difference versus Enoxaparin||13.3|3.4|0.0009
72425566|NCT00152971|144362681|SUPERIORITY_OR_OTHER||Risk Difference (Percentage)|1.2||||0.2139||95.0|-0.7|3.0|||Normal approximation|Normal approximation of independent binomial distribution without stratification||Risk difference versus Enoxaparin||3.0|-0.7|0.2139
72334733|NCT02743949|144192207|SUPERIORITY||Wilcoxon-Mann-Whitney odds estimator|1.0584||||0.748|TWO_SIDED|97.5|0.71|1.5778||P-values were obtained using a Pearson chi-square test for each Vonoprazan treatment compared with Esomeprazole.|Wilcoxon rank-sum test|||||1.5778|0.7100|0.7480
72425567|NCT00152971|144362681|SUPERIORITY_OR_OTHER||Risk Difference (Percentage)|0.8||||0.3628||95.0|-0.9|2.5|||Normal approximation|Normal approximation of independent binomial distribution without stratification||Risk difference versus Enoxaparin||2.5|-0.9|0.3628
72425568|NCT00152971|144362682|SUPERIORITY_OR_OTHER||Risk Difference (Percentage)|0.9||||0.2309||95.0|-0.6|2.5|||Normal approximation|Normal approximation of independent binomial distribution without stratification||Risk difference versus Enoxaparin||2.5|-0.6|0.2309
72425569|NCT00152971|144362682|SUPERIORITY_OR_OTHER||Risk Difference (Percentage)|1.5||||0.0602||95.0|-0.1|3.2|||Normal approximation|Normal approximation of independent binomial distribution without stratification||Risk difference versus Enoxaparin||3.2|-0.1|0.0602
72334734|NCT02743949|144192207|SUPERIORITY||Wilcoxon-Mann-Whitney odds estimator|1.0975||||0.5985|TWO_SIDED|97.5|0.7368|1.6349||P-values were obtained using a Pearson chi-square test for each Vonoprazan treatment compared with Esomeprazole.|Wilcoxon rank-sum test|||||1.6349|0.7368|0.5985
72334735|NCT02743949|144192208|SUPERIORITY||Miettinen-Nurminen|0.91||||0.782|TWO_SIDED|97.5|0.44|1.91||P-values were obtained using a Pearson chi-square test for each Vonoprazan treatment compared with Esomeprazole.|Pearson chi-square|||||1.91|0.44|0.782
72425570|NCT00152971|144362683|SUPERIORITY_OR_OTHER||Risk Difference (Percentage)|5.9||||0.0194||95.0|1.0|10.9|||Normal approximation|Normal approximation of independent binomial distribution without stratification||Risk difference versus Enoxaparin||10.9|1.0|0.0194
72334736|NCT02743949|144192208|SUPERIORITY||Miettinen-Nurminen|0.96||||0.912|TWO_SIDED|97.5|0.46|2.01||P-values were obtained using a Pearson chi-square test for each Vonoprazan treatment compared with Esomeprazole.|Pearson chi-square|||||2.01|0.46|0.912
72425571|NCT00152971|144362683|SUPERIORITY_OR_OTHER||Risk Difference (Percentage)|8.9||||0.0004||95.0|4.0|13.9|||Normal approximation|Normal approximation of independent binomial distribution without stratification||Risk difference versus Enoxaparin||13.9|4.0|0.0004
72425572|NCT00152971|144362684|SUPERIORITY_OR_OTHER|||||||0.5774||95.0|||||Fisher Exact|||Comparison versus Enoxaparin||||0.5774
72425573|NCT00152971|144362684|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|||Comparison versus Enoxaparin||||1.0000
72425574|NCT00152971|144362685|SUPERIORITY_OR_OTHER|||||||0.7724||95.0|||||Fisher Exact|||Comparison versus Enoxaparin||||0.7724
72334737|NCT03389555|144192209|EQUIVALENCE|Equivalence margin: if confidence interval for mean difference between SOFA scores at 72 hour time-point for two groups overlaps 0 (p-value \> 0.05) scores considered to be equivalent. Note: The model estimates the mean difference in SOFA score at 72 hours between treatment and control groups, for those patient for whom a SOFA score could be calculated at the 72 hour time point (i.e patients that were alive at the 72 hour time point, 90 patients in the treatment and 88 patients in the control).|Mean Difference (Net)|-0.8||||0.12|TWO_SIDED|95.0|-1.7|0.2||A priori threshold for significance, p-value \< 0.05|Mixed Models Analysis|||The primary outcome was analyzed using a linear mixed-effects model where the correlation of within-patient repeated SOFA score measures was accounted for via the use of an unstructured variance-covariance matrix and linear contrasts. Covariates included age, sex, treatment group, time, and the interaction between treatment group and time. Study site was included as a random intercept. The model estimates the mean difference in SOFA score at 72 hours between treatment and control groups.||0.2|-1.7|0.12
72334738|NCT03389555|144192210|EQUIVALENCE|For the key secondary outcome of kidney failure, 200 patients were estimated to provide 94% power, assuming that 30% of participants in the treatment group and 55% in the placebo group would develop kidney failure. If the adjusted risk difference from the logistic regression analysis overlaps 0, there was considered to be no difference between groups|Risk Difference (RD)|3.0||||0.58|TWO_SIDED|95.0|-10.0|20.0|||Regression, Logistic|||Logistic regression analysis evaluating the key secondary outcome of kidney failure in treatment group (intervention versus placebo) controlling for treatment site.||20.0|-10.0|0.58
72334739|NCT03389555|144192211|EQUIVALENCE|If confidence interval for hazard ratio crosses 0, hazard of death assumed to be equivalent in the two groups.|Hazard Ratio (HR)|1.3||||0.05|TWO_SIDED|95.0|0.8|2.2|||Regression, Cox|||Cox Regression controlling for site used to identify hazard ratio for outcome of death for treatment versus intervention group. Null hypothesis is that hazard ratio is 1.||2.2|0.8|0.05
72334740|NCT03389555|144192212|EQUIVALENCE|If the confidence interval for the median difference in ventilator free days between groups crosses 0, the two groups are considered equivalent.|Median Difference (Net)|0.0|||>|0.99|TWO_SIDED|95.0|-1.9|1.9|||Quantile Regression|||Quantile regression controlling for site performed to compare treatment and control group's ventilator free days.||1.9|-1.9|>0.99
72334741|NCT03389555|144192213|EQUIVALENCE|If the confidence interval for the median difference in shock free days between groups crosses 0, the two groups are considered equivalent.|Median Difference (Net)|1.0||||0.02|TWO_SIDED|95.0|0.2|1.8|||Quantile Regression|||Quantile regression controlling for site performed to compare treatment and control group's shock free days.||1.8|0.2|0.02
72425575|NCT00152971|144362685|SUPERIORITY_OR_OTHER|||||||0.0308||95.0|||||Fisher Exact|||Comparison versus Enoxaparin||||0.0308
72334742|NCT03389555|144192214|EQUIVALENCE|If the confidence interval for the median difference in ICU free days between groups crosses 0, the two groups are considered equivalent.|Median Difference (Net)|1.0||||0.69|TWO_SIDED|95.0|-3.0|6.0|||Quantile Regression|||Quantile regression controlling for site performed to compare treatment and control group's ICU free days.||6.0|-3.0|0.69
72425576|NCT00152971|144362686|SUPERIORITY_OR_OTHER|||||||0.4968||95.0|||||Fisher Exact|||Comparison versus Enoxaparin||||0.4968
72334743|NCT03389555|144192215|EQUIVALENCE|If the adjusted risk difference from the logistic regression analysis overlaps 0, there was considered to be no difference between groups|Risk Difference (RD)|3.0||||0.55|TWO_SIDED|95.0|-10.0|20.0|||Regression, Logistic|||Logistic regression analysis evaluating the key secondary outcome of hospital mortality in treatment group (intervention versus placebo) controlling for treatment site..||20.0|-10.0|0.55
72425577|NCT00152971|144362686|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|||Comparison versus Enoxaparin||||1.0000
72425578|NCT00152971|144362688|SUPERIORITY_OR_OTHER|||||||0.1416||95.0|||||Fisher Exact|||Comparison versus Enoxaparin||||0.1416
72334744|NCT03389555|144192216|EQUIVALENCE|If the adjusted risk difference from the logistic regression analysis overlaps 0, there was considered to be no difference between groups|Risk Difference (RD)|2.0||||0.8|TWO_SIDED|95.0|-10.0|10.0|||Regression, Logistic|||Logistic regression analysis evaluating the key secondary outcome of ICU mortality in treatment group (intervention versus placebo) controlling for treatment site.||10.0|-10.0|0.80
72334745|NCT03389555|144192217|EQUIVALENCE|If the adjusted risk difference from the logistic regression analysis overlaps 0, there was considered to be no difference between groups|Risk Difference (RD)|-12.0||||0.16|TWO_SIDED|95.0|-25.0|4.0|||Regression, Logistic|||Logistic regression analysis evaluating the key secondary outcome of occurrence of delirium in treatment group (intervention versus placebo) controlling for treatment site.||4|-25|0.16
72334746|NCT03389555|144192218|EQUIVALENCE|If the adjusted risk difference from the logistic regression analysis overlaps 0, there was considered to be no difference between groups|Risk Difference (RD)|-1.8||||0.82|TWO_SIDED|95.0|-18.0|14.0|||Regression, Logistic|||Logistic regression analysis evaluating home hospital disposition in survivors to hospital discharge in intervention versus placebo group controlling for treatment site.||14|-18|0.82
72334747|NCT00920218|144192231|SUPERIORITY|Criterion for superiority: The Lower Limit (LL) of the Confidence Interval (CI) of the ratio of geometric means, in terms of ceellular immune (CMI) response for GSK 1437173A F1 Group as compared to Placebo Group, is above (\>) 2.|Fold increase over Control|32.31|||<|0.0001|TWO_SIDED|76.16|20.65|50.54|||Dunnett for multiple comparisons|||The null hypothesis was H0: GSK 1437173A F1 Group/Placebo Group below (\<) 1.||50.54|20.65|<0.0001
72425579|NCT00152971|144362688|SUPERIORITY_OR_OTHER|||||||0.0942||95.0|||||Fisher Exact|||Comparison versus Enoxaparin||||0.0942
72425580|NCT01396395|144362751|SUPERIORITY_OR_OTHER||Ratio|0.503|||<|0.0001|TWO_SIDED|95.0|0.435|0.581|||poisson regression: Non-calibration mode|||||0.581|0.435|<0.0001
72334748|NCT00920218|144192231|SUPERIORITY|Criterion for superiority: The Lower Limit (LL) of the Confidence Interval (CI) of the ratio of geometric means, in terms of CMI response for Placebo-GSK 1437173A F1 Group as compared to Placebo Group, is above (\>) 2.|Fold increase over Control|9.51|||<|0.0001|TWO_SIDED|76.16|6.07|14.9|||Dunnett for multiple comparisons|||The null hypothesis was H0: Placebo-GSK 1437173A F1 Group/Placebo Group \< 2.||14.9|6.07|<0.0001
72334749|NCT00920218|144192232|SUPERIORITY|Criterion for superiority: The Lower Limit (LL) of the Confidence Interval (CI) of the ratio of geometric means, in terms of humoral response for GSK 1437173A F1 Group as compared to Placebo Group, is above (\>) 3.|Fold increase over Control|74.41|||<|0.0001|TWO_SIDED|76.16|33.12|167.17|||Dunnett for multiple comparisons|||The null hypothesis was H0: GSK 1437173A 1 Group/Placebo Group \< 1.||167.17|33.12|<0.0001
72334750|NCT00920218|144192232|SUPERIORITY|Criterion for superiority: The Lower Limit (LL) of the Confidence Interval (CI) of the ratio of geometric means, in terms of humoral response for Placebo-GSK 1437173A F1 Group as compared to Placebo Group, is above (\>) 3.|Fold increase over Control|42.2|||<|0.0001|TWO_SIDED|76.16|20.2|88.13|||Dunnett for multiple comparisons|||The null hypothesis was H0: Placebo-GSK 1437173A 1 Group/Placebo Group \< 1.||88.13|20.20|<0.0001
72334751|NCT01007435|144192241|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.77|||<|0.0001|TWO_SIDED|95.0|3.19|7.14||A hierarchy of statistical testing was implemented in order to control the type I error rate for multiple comparisons.|Regression, Logistic|The stratification factors, region and serologic status, were included in the model.|"Last observation carried forward was used for TJC and SJC. No imputation was used for ESR and GH. Patients who withdrew prematurely or where a DAS28 could not be calculated were set to non-responder."|The null hypothesis is that there is no difference in the DAS28 remission response at Week 24 between the placebo to tocilizumab + methotrexate and the tocilizumab 8 mg/kg + methotrexate treatment groups.||7.14|3.19|<0.0001
72334752|NCT01007435|144192241|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.7|||<|0.0001|TWO_SIDED|95.0|2.47|5.55||A hierarchy of statistical testing was implemented in order to control the type I error rate for multiple comparisons.|Regression, Logistic|The stratification factors, region and serologic status, were included in the model.|"Last observation carried forward was used for TJC and SJC. No imputation was used for ESR and GH. Patients who withdrew prematurely or where a DAS28 could not be calculated were set to non-responder."|The null hypothesis is that there is no difference in the DAS28 remission response at Week 24 between the placebo to tocilizumab + methotrexate and the tocilizumab 8 mg/kg + placebo to methotrexate treatment groups.||5.55|2.47|<0.0001
72334753|NCT01007435|144192241|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.72|||<|0.0001|TWO_SIDED|95.0|1.8|4.11||A hierarchy of statistical testing was implemented in order to control the type I error rate for multiple comparisons. This comparison came after the break in statistical hierarchy.|Regression, Logistic|The stratification factors, region and serologic status, were included in the model.|"Last observation carried forward was used for TJC and SJC. No imputation was used for ESR and GH. Patients who withdrew prematurely or where a DAS28 could not be calculated were set to non-responder."|The null hypothesis is that there is no difference in the DAS28 remission response at Week 24 between the placebo to tocilizumab + methotrexate and the tocilizumab 4 mg/kg + methotrexate treatment groups.||4.11|1.80|<0.0001
72334754|NCT02163967|144192255|OTHER||||||<|0.02||||||Mixed effects regression model, a nested (within subject) random intercept for dose, fixed effects for age, dose, time and dose x time interaction. Significance level p=.05, Bonferonni correction was used for post-hoc tests.|Regression, Linear|Post-hoc comparisons using least-square means. Kenward-Roger adjustments to denominator degrees of freedom.Increase in HRV at 2Amp compared to sham.||The null hypothesis is that there is no difference in High frequency HRV after 20 minutes of stimulation or 15 minutes after cessation of stimulation at the low (1mAmp) or high (2mAmp) dose compared to sham stimulation||||<.02
72334755|NCT02163967|144192256|OTHER||||||<|0.001|||||||Chi-squared|||The null hypothesis is that there will be no difference in the number of side effects reported during either dose of stimulation compared to sham stimulation. Statistical differences were examined for light flickering in peripheral vision . Other side effects were reported by too few subjects to be analyzed statistically.||||<.001
72425581|NCT01396395|144362751|SUPERIORITY_OR_OTHER||Ratio|0.503|||=|0.0086|TWO_SIDED|95.0|0.301|0.84|||Poisson regression: Calibration model|||||0.840|0.301|=0.0086
72425582|NCT00882921|144362774|SUPERIORITY_OR_OTHER_LEGACY||Relative Risk|2.873||||0.1309|TWO_SIDED|95.0|0.731|11.296|||Negative Binomial Model|||The groups compared are Ab+ vs Ab-||11.296|0.731|0.1309
72425583|NCT00882921|144362774|SUPERIORITY_OR_OTHER_LEGACY||Relative Risk|2.082||||0.2718|TWO_SIDED|95.0|0.563|7.706|||Negative Binomial Model|||The groups compared are Ab+ (age adjusted) vs Ab- (age adjusted)||7.706|0.563|0.2718
72425584|NCT02301156|144362788|SUPERIORITY|||||||0.0463|||||||Cochran-Mantel-Haenszel|P-value was estimated by Cochran-Mantel-Haenszel (CMH) test stratified by the randomization strata prior lines of therapy.||||||0.0463
72334756|NCT02163967|144192257|OTHER|||||||0.81||||||Mixed effects regression model, a nested (within subject) random intercept for dose, fixed effects for age, dose, time and dose x time interaction. Significance level p=.05, Bonferonni correction was used for post-hoc tests.|Regression, Linear|Post-hoc comparisons were made using least-square means. Kenward-Roger adjustments to denominator degrees of freedom.||||||0.81
72334757|NCT02163967|144192258|OTHER|||||||0.47||||||Mixed effects regression model, a nested (within subject) random intercept for dose, fixed effects for age, dose, time and dose x time interaction. Significance level p=.05, Bonferonni correction was used for post-hoc tests.|Regression, Linear|Post-hoc comparisons were made using least-square means. Kenward-Roger adjustments to denominator degrees of freedom.||||||0.47
72334758|NCT01425359|144192312|SUPERIORITY_OR_OTHER|||||||0.008|TWO_SIDED|||||Angina frequency was compared by fitting a generalized linear model with log link and negative binomial distribution response.|Generalized linear model|||||||0.008
72334759|NCT01425359|144192313|SUPERIORITY_OR_OTHER|||||||0.003|TWO_SIDED|||||Sublingual nitroglycerin use frequency was compared by fitting a generalized linear model with log link and negative binomial distribution response.|Generalized linear model|||||||0.003
72334760|NCT03520348|144192326|NON_INFERIORITY|It is considered less than 20% of differences between groups to consider non-inferiority||||||0.285|||||||Wilcoxon (Mann-Whitney)|||||||0.285
72334761|NCT03520348|144192327|NON_INFERIORITY|it is considered noninferiority if there are no differences in the 20% between the research drug and the reference medicine||||||0.68|||||||Wilcoxon (Mann-Whitney)|||||||0.680
72334762|NCT03520348|144192328|NON_INFERIORITY|it is considered noninferiority if there are no differences in the 20% between the research drug and the reference medicine||||||0.839|||||||Wilcoxon (Mann-Whitney)|||||||0.839
72334763|NCT03520348|144192329|NON_INFERIORITY|it is considered noninferiority if there are no differences in the 20% between the research drug and the reference medicine||||||0.137|||||||Wilcoxon (Mann-Whitney)|||||||0.137
72425585|NCT02301156|144362789|SUPERIORITY|||||||0.0159|||||||Cochran-Mantel-Haenszel|P-value was estimated by CMH test stratified by the randomization strata prior lines of therapy.||||||0.0159
72425586|NCT02301156|144362790|SUPERIORITY||Rate Difference|35.64|||<|0.0001|TWO_SIDED|95.0|21.39|49.88|||Cochran-Mantel-Haenszel|P-value was estimated using CMH test stratified by the randomization strata prior lines of therapy.|95% Confidence Interval (CI) was estimated using Clopper-Pearson method based on the binomial distribution.|||49.88|21.39|<0.0001
72334764|NCT03520348|144192331|NON_INFERIORITY|it is considered noninferiority if there are no differences in the 20% between the research drug and the reference medicine||||||0.667|||||||Chi-squared, Corrected|||||||0.667
72334765|NCT03520348|144192332|NON_INFERIORITY|it is considered noninferiority if there are no differences in the 20% between the research drug and the reference medicine||||||0.561|||||||Chi-squared, Corrected|||||||0.561
72334766|NCT03520348|144192333|NON_INFERIORITY|it is considered noninferiority if there are no differences in the 20% between the research drug and the reference medicine||||||1|||||||Chi-squared|||||||1.000
72334767|NCT03520348|144192334|NON_INFERIORITY|it is considered noninferiority if there are no differences in the 20% between the research drug and the reference medicine||||||0.317|||||||Chi-squared, Corrected|||||||0.317
72334768|NCT03520348|144192335|NON_INFERIORITY|it is considered noninferiority if there are no differences in the 20% between the research drug and the reference medicine||||||0.414|||||||Chi-squared, Corrected|||||||0.414
72334769|NCT02292758|144192336|SUPERIORITY||Hazard Ratio (HR)|0.912||||0.7609|TWO_SIDED|95.0|0.431|1.93|||Log Rank||Unadjusted HR; Model stratified by: prior bevacizumab (Y vs N) and prior lines of chemotherapy (1 vs 2+)|||1.930|0.431|0.7609
72334770|NCT02292758|144192336|SUPERIORITY||Hazard Ratio (HR)|0.642|||||TWO_SIDED|95.0|0.249|1.656|||||Adjusted HR; Model adjusted by: age, gender, race (white vs others), number of metastatic sites (1 vs 2 vs 3+), ECOG PS (0 vs 1), tumor site (colon, rectum/rectosigmoid, multiple)|||1.656|0.249|
72334771|NCT02292758|144192339|SUPERIORITY||Hazard Ratio (HR)|0.471||||0.0446|TWO_SIDED|95.0|0.209|1.062|||Log Rank||Unadjusted HR; Model stratified by: prior bevacizumab (Y vs N) and prior lines of chemotherapy (1 vs 2+)|||1.062|0.209|0.0446
72334772|NCT02292758|144192339|SUPERIORITY||Hazard Ratio (HR)|0.406|||||TWO_SIDED|95.0|0.151|1.089|||||Adjusted HR; Model adjusted by: age, gender, race (white vs others), number of metastatic sites (1 vs 2 vs 3+), ECOG PS (0 vs 1), tumor site (colon, rectum/rectosigmoid, multiple)|||1.089|0.151|
72334773|NCT02292758|144192341|SUPERIORITY|||||||0.3415|||||||Chi-squared|||||||0.3415
72334774|NCT02292758|144192342|SUPERIORITY|||||||0.1279|||||||Fisher Exact|||||||0.1279
72334775|NCT02292758|144192343|SUPERIORITY|||||||0.447|||||||Log Rank|||||||0.447
72334776|NCT02292758|144192344|SUPERIORITY||Hazard Ratio (HR)|0.755||||0.3738|TWO_SIDED|95.0|0.345|1.655|||Log Rank||Unadjusted HR; Model stratified by: prior bevacizumab (Y vs N) and prior lines of chemotherapy (1 vs 2+)|||1.655|0.345|0.3738
72334777|NCT02292758|144192345|SUPERIORITY|||||||0.4283|||||||Wilcoxon (Mann-Whitney)|||Cetuximab comparison||||0.4283
72334778|NCT02292758|144192345|SUPERIORITY|||||||0.5262|||||||Wilcoxon (Mann-Whitney)|||Irinotecan comparison||||0.5262
72334779|NCT00075946|144192401|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.3||||0.33|TWO_SIDED|95.0|0.9|1.88|||Log Rank||Hazard ratio is for Rituximab Retreatment Arm/Rituximab Scheduled Arm in follicular patients.|The primary analysis is to compare the time to rituximab failure (TTRF) between the retreatment arm and the scheduled arm in follicular patients.||1.88|0.90|0.33
72334780|NCT00075946|144192401|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|2.75||||0.012|TWO_SIDED|95.0|1.22|6.19|||Log Rank||Hazard ratio is for Rituximab Retreatment Arm/Rituximab Scheduled Arm in non-follicular patients.|||6.19|1.22|0.012
72334781|NCT00075946|144192402|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|3.21||||0.002|TWO_SIDED|95.0|1.45|7.13|||Log Rank||Hazard ratio is for Rituximab Retreatment Arm/Rituximab Scheduled Arm in follicular patients.|||7.13|1.45|0.002
72334782|NCT00075946|144192402|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0002|TWO_SIDED||||||Log Rank|||||||0.0002
72334783|NCT00075946|144192403|SUPERIORITY_OR_OTHER_LEGACY|||||||0.27|TWO_SIDED||||||t-test, 2 sided|||||||0.270
72334784|NCT03639623|144192410|OTHER|||||||0.053|||||||paired t-test|||||||0.053
72334785|NCT03639623|144192411|OTHER|||||||0.958|||||||paired t-test|||||||0.958
72334786|NCT03639623|144192412|OTHER|||||||0.011|||||||paired t-test|||||||0.011
72334787|NCT03639623|144192413|OTHER|||||||0.454|||||||paired t-test|||||||0.454
72334788|NCT03639623|144192414|OTHER|||||||0.154|||||||paired t-test|||||||0.154
72425587|NCT02301156|144362791|SUPERIORITY||Hazard Ratio (HR)|0.573||||0.0961|TWO_SIDED|95.0|0.295|1.113|||Log Rank|P-value was estimated by stratified log rank test and the stratification was based on the randomization strata prior lines of therapy.|Stratified Hazard Ratio and 95% CI were estimated using Cox proportion hazard model and the stratification was based on the randomization strata prior lines of therapy.|||1.113|0.295|0.0961
72334789|NCT03639623|144192415|OTHER|||||||0.125|||||||paired t-test|||Outcome Variable: ALT||||0.125
72425588|NCT02301156|144362792|SUPERIORITY||Hazard Ratio (HR)|0.569||||0.1486|TWO_SIDED|95.0|0.263|1.234|||Log Rank|P-value was estimated by stratified log rank test and the stratification was based on the randomization strata prior lines of therapy.|Stratified Hazard Ratio and 95% CI were estimated using Cox proportion hazard model and the stratification was based on the randomization strata prior lines of therapy.|||1.234|0.263|0.1486
72425589|NCT02301156|144362793|SUPERIORITY||Hazard Ratio (HR)|2.163||||0.0004|TWO_SIDED|95.0|1.399|3.344|||Log Rank|P-value was estimated by stratified log rank test and the stratification was based on the randomization strata prior lines of therapy.|Stratified Hazard Ratio and 95% CI were estimated using Cox proportion hazard model and the stratification was based on the randomization strata prior lines of therapy.|||3.344|1.399|0.0004
72425590|NCT02090634|144362795|SUPERIORITY|||||||0.95||||||Cliff's d = 0.01; calculated to estimate the effect size for between-group comparisons with non-parametric data|Wilcoxon (Mann-Whitney)|||We conducted Wilcoxon rank sum (Mann-Whitney) tests in order to examine group (i.e., iTAB vs. CTRL) differences on overall adherence to ARV medications.||||0.95
72425591|NCT02090634|144362795|SUPERIORITY|||||||0.43|||||||Wilcoxon (Mann-Whitney)|Cliff's d = -0.13; calculated to estimate the effect size for between-group comparisons with non-parametric data||We conducted Wilcoxon rank sum (Mann-Whitney) tests in order to examine group (i.e., iTAB vs. CTRL) differences on overall adherence to PSY medications.||||0.43
72425592|NCT02090634|144362796|SUPERIORITY|||||||0.02||||||Cliff's d = 0.37; calculated to estimate the effect size for between-group comparisons with non-parametric data|Wilcoxon (Mann-Whitney)|||We conducted Wilcoxon rank sum (Mann-Whitney) tests in order to examine group (i.e., iTAB vs. CTRL) differences on overall dose timing windows for ARV medications.||||0.02
72334790|NCT03639623|144192415|OTHER|||||||0.375|||||||paired t-test|||Outcome Variable: AST||||0.375
72334791|NCT03639623|144192415|OTHER||||||<|0.001|||||||paired t-test|||Outcome Variable: ALP||||<0.001
72334792|NCT03639623|144192416|OTHER|||||||0.054|||||||paired t-test|||||||0.054
72334793|NCT03639623|144192417|OTHER|||||||0.378|||||||paired t-test|||Outcome variable: Total Cholesterol||||0.378
72334794|NCT03639623|144192417|OTHER|||||||0.01|||||||paired t-test|||Outcome Variable: Triglyceride||||0.010
72334795|NCT03639623|144192417|OTHER|||||||0.264|||||||paired t-test|||Outcome Variable: Non-HDL-C||||0.264
72334796|NCT03639623|144192417|OTHER|||||||0.954|||||||paired t-test|||Outcome Variable: HDL-C||||0.954
72425593|NCT02090634|144362796|SUPERIORITY|||||||0.42||||||Cliff's d = 0.14; calculated to estimate the effect size for between-group comparisons with non-parametric data|Wilcoxon (Mann-Whitney)|||We conducted Wilcoxon rank sum (Mann-Whitney) tests in order to examine group (i.e., iTAB vs. CTRL) differences on overall dose timing windows for PSY medications.||||0.42
72425594|NCT01103960|144362818|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.1881|STANDARD_ERROR_OF_MEAN|0.803||0.007||95.0|0.6082|3.7681||This was the first step in the closed testing procedure of multiple endpoints. The p-value was \<0.05 so this test was considered confirmatory. Proceeding to the next step was allowed, testing the same endpoint in the subgroup of Chinese patients.|ANCOVA|||A5 minus T80/A5||3.7681|0.6082|0.007
72425595|NCT01103960|144362819|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.9195|STANDARD_ERROR_OF_MEAN|0.9015||0.034||95.0|0.1443|3.6947||This was the second step in the closed testing procedure of multiple endpoints. The p-value was again \<0.05 so this test was also considered confirmatory.|ANCOVA|||A5 minus T80/A5||3.6947|0.1443|0.034
72425596|NCT01103960|144362820|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.4879|STANDARD_ERROR_OF_MEAN|1.1217|<|0.001||95.0|2.2807|6.695|||ANCOVA|||A5 minus T80/A5||6.6950|2.2807|<0.001
72425597|NCT02875834|144362828|OTHER||Mean Difference (Final Values)|0.904|||<|0.001|TWO_SIDED|95.0|0.876|0.933|||Mixed Models Analysis|||Results derived from a mixed effects model of log-transformed S-K levels. Fixed effects are: treatment group; visit; treatment-by-visit interaction; baseline S-K values (OLP and RTP); baseline eGFR; age category; country; baseline RAAS inhibitor, chronic kidney disease, heart failure, and diabetes mellitus statuses. Patient is a random effect. p-values given are for differences of LSMEANS. The back-transformation is to the original scale of the S-K measurement.||0.933|0.876|<0.001
72334797|NCT03639623|144192417|OTHER|||||||0.127|||||||paired t-test|||Outcome Variable: HDL-C Subclass 2||||0.127
72425598|NCT02875834|144362828|OTHER||Mean Difference (Final Values)|0.823|||<|0.001|TWO_SIDED|95.0|0.797|0.85|||Mixed Models Analysis|||||0.850|0.797|<0.001
72425599|NCT02875834|144362833|OTHER||Odds Ratio (OR)|6.3436|||<|0.001|TWO_SIDED|95.0|2.6866|14.9782|||Regression, Logistic|||Treatment group comparisons were made using a logistic regression model containing the following covariates: treatment group; both baseline S-K values (48-hours open-label initial phase and double-blind randomized phase); baseline eGFR (during 48-hour open-label initial phase); age category (\<55, 55-64, \>=65 years); country; baseline RAAS inhibitor, chronic kidney disease, heart failure, and diabetes mellitus statuses.||14.9782|2.6866|<0.001
72334798|NCT03639623|144192417|OTHER|||||||0.029|||||||paired t-test|||Outcome Variable: HDL-C Subclass 3||||0.029
72334799|NCT03639623|144192417|OTHER|||||||0.63|||||||paired t-test|||Outcome variable: LDL-C||||0.630
72334800|NCT03639623|144192417|OTHER|||||||0.01|||||||paired t-test|||Outcome Variable: VLDL-C||||0.010
72334801|NCT03639623|144192417|OTHER|||||||0.16|||||||paired t-test|||Outcome Variable: VLDL concentration||||0.160
72334802|NCT03639623|144192417|OTHER|||||||0.02|||||||paired t-test|||Small dense LDL-C||||0.020
72334803|NCT03639623|144192418|OTHER|||||||0.529|||||||paired t-test|||||||0.529
72334804|NCT03639623|144192419|OTHER|||||||0.403|||||||paired t-test|||Outcome Variable: LDL Size||||0.403
72334805|NCT03639623|144192420|OTHER|||||||0.669|||||||paired t-test|||||||0.669
72334806|NCT03639623|144192421|OTHER|||||||0.021|||||||paired t-test|||Outcome Variable: VLDL chylomicron particles||||0.021
72334807|NCT03639623|144192421|OTHER|||||||0.011|||||||paired t-test|||Outcome Variable: Large VLDL chylomicron particles||||0.011
72334808|NCT03639623|144192421|OTHER|||||||0.06|||||||paired t-test|||Outcome Variable: Medium VLDL particles||||0.060
72334809|NCT03639623|144192421|OTHER|||||||0.324|||||||paired t-test|||Outcome Variable: Small VLDL particles||||0.324
72334810|NCT03639623|144192422|OTHER|||||||0.01|||||||paired t-test|||||||0.010
72334811|NCT03639623|144192423|OTHER|||||||0.249|||||||paired t-test|||||||0.249
72334812|NCT03639623|144192424|OTHER|||||||0.0193|||||||paired t-test|||Time to peak RQ||||0.0193
72334813|NCT03639623|144192425|OTHER|||||||0.96|||||||paired t-test|||Outcome Variable: Physical component score||||0.960
72334814|NCT03639623|144192425|OTHER|||||||0.249|||||||paired t-test|||Outcome Variable: Mental component score||||0.249
72334815|NCT00889603|144192438|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.92|||||TWO_SIDED|95.0|1.65|2.2|||||Change from baseline in MMSE at LOCF analyzed using single-sample t-test; a 95% confidence interval (CI) was calculated for mean change at LOCF.|||2.20|1.65|
72334816|NCT00889603|144192439|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.92|||||TWO_SIDED|95.0|0.75|1.08|||||LS Mean and 95% CI for change from baseline in MMSE Total to Week 8 from repeated-measures mixed model including terms for baseline MMSE and Week.|||1.08|0.75|
72334817|NCT00889603|144192439|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.56|||||TWO_SIDED|95.0|1.32|1.8|||||LS Mean and 95% CI for change from baseline in MMSE Total to Week 16 from a repeated-measures mixed model including terms for baseline MMSE and Week.|||1.80|1.32|
72334818|NCT00889603|144192439|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.97|||||TWO_SIDED|95.0|1.69|2.25|||||LS Mean and 95% CI for change from baseline in MMSE Total to Week 24 from a repeated-measures mixed model including terms for baseline MMSE and Week.|||2.25|1.69|
72334819|NCT01229254|144192448|EQUIVALENCE|If the 90% confidence interval was within the pre-specified bounds of \[0.66, 1.50\], the hypothesis of similarity between lower weight and higher weight groups was supported.|Ratio of geometric least-squares means|0.748|||||TWO_SIDED|90.0|0.591|0.948||||||Compared to Betrixaban 90 mg (≥80 kg)||0.948|0.591|
72334820|NCT03022097|144192480|SUPERIORITY||Least squares mean difference|0.092|STANDARD_ERROR_OF_MEAN|0.016|<|0.001|TWO_SIDED|95.0|0.06|0.124||Pre-specified hierarchical sequence of testing used to adjust for multiplicity.|Mixed Models Analysis|Screening pre- and post-bronchodilator FEV1, age, baseline FEV1 as covariates; treatment, country, smoking, visit and group-by-visit as factors.||||0.124|0.060|<0.001
72334821|NCT03022097|144192481|SUPERIORITY||Least squares mean difference|0.085|STANDARD_ERROR_OF_MEAN|0.016|<|0.001|TWO_SIDED|95.0|0.053|0.117||Pre-specified hierarchical sequence of testing used to adjust for multiplicity.|Mixed Models Analysis|Screening pre- and post-bronchodilator FEV1, age, baseline FEV1 as covariates; treatment, country, smoking, visit and group-by-visit as factors.||||0.117|0.053|<0.001
72334822|NCT03022097|144192482|SUPERIORITY||Least squares mean difference|0.134|STANDARD_ERROR_OF_MEAN|0.016|<|0.001|TWO_SIDED|95.0|0.103|0.166||Pre-specified hierarchical sequence of testing used to adjust for multiplicity.|Mixed Models Analysis|Screening pre- and post-bronchodilator FEV1, age, baseline FEV1 as covariates; treatment, country, smoking, visit and group-by-visit as factors.||||0.166|0.103|<0.001
72334823|NCT03022097|144192483|SUPERIORITY||Least squares mean difference|0.217|STANDARD_ERROR_OF_MEAN|0.017|<|0.001|TWO_SIDED|95.0|0.184|0.25||Pre-specified hierarchical sequence of testing used to adjust for multiplicity.|Mixed Models Analysis|Screening pre- and post-bronchodilator FEV1, age, baseline FEV1 as covariates; treatment, country, smoking, visit and group-by-visit as factors.||||0.250|0.184|<0.001
72334824|NCT03022097|144192484|SUPERIORITY||Least squares mean difference|0.8|STANDARD_ERROR_OF_MEAN|0.3||0.005|TWO_SIDED|95.0|0.2|1.3||Pre-specified hierarchical sequence of testing used to adjust for multiplicity.|Mixed Models Analysis|BDI, age as covariates; treatment, country, smoking, visit and group-by-visit as factors.||||1.3|0.2|0.005
72334825|NCT03022097|144192484|SUPERIORITY||Least squares mean difference|0.4|STANDARD_ERROR_OF_MEAN|0.3||0.132|TWO_SIDED|95.0|-0.1|1.0||Pre-specified hierarchical sequence of testing used to adjust for multiplicity.|Mixed Models Analysis|BDI, age as covariates; treatment, country, smoking, visit and group-by-visit as factors.||||1.0|-0.1|0.132
72334826|NCT03022097|144192485|SUPERIORITY||Least squares mean difference|-4.0|STANDARD_ERROR_OF_MEAN|1.3||0.003|TWO_SIDED|95.0|-6.7|-1.4||Pre-specified hierarchical sequence of testing used to adjust for multiplicity. P-value is nominal.|Mixed Models Analysis|Baseline SGRQ, age as covariates; treatment, country, smoking, visit and group-by-visit as factors.||||-1.4|-6.7|0.003
72334827|NCT03022097|144192485|SUPERIORITY||Least squares mean difference|-2.9|STANDARD_ERROR_OF_MEAN|1.3||0.031|TWO_SIDED|95.0|-5.5|-0.3||Pre-specified hierarchical sequence of testing used to adjust for multiplicity. P-value is nominal.|Mixed Models Analysis|Baseline SGRQ, age as covariates; treatment, country, smoking, visit and group-by-visit as factors.||||-0.3|-5.5|0.031
72334828|NCT01349322|144192494|NON_INFERIORITY|Non-inferiority is defined as a hazard ratio upper limit of 2.12.|Hazard Ratio (HR)|1.32||||0.039|TWO_SIDED|90.0|0.84|2.05|||Regression, Cox||Cause-specific hazard ratio; reference level = Arm 1.|"Assuming Arm 1 5-year IBR of 1.59%, for hypothesized upper bound hazard ratio (HR) of 2.12 (Arm 2 5-year IBR of 3.33%), 46 IBR events provide \>80% power to conclude non-inferiority with one-sided significance level = 0.05. Null hypothesis: HR ≥ 2.12 (inferior). Alternative hypothesis: HR \< 2.12 (non-inferior). See Limitations and Caveats section."||2.05|0.84|0.039
72334829|NCT01349322|144192495|SUPERIORITY|||||||0.96||||||Two-sided significance level = 0.05|Log Rank|||||||0.96
72334830|NCT01349322|144192496|SUPERIORITY|||||||0.14||||||Two-sided significance level = 0.05.|Log Rank|||||||0.14
72334831|NCT01349322|144192497|SUPERIORITY|||||||0.34||||||Two-sided significance level = 0.05|Log Rank|||||||0.34
72334832|NCT01349322|144192499|NON_INFERIORITY|Null hypothesis (H0) of inferiority: the mean change in cosmetic subscale score in Arm 2 will be at least 0.4 standard deviations worse than in Arm 1. If H0 is rejected, then non-inferiority can be concluded.|Mean Difference (Final Values)|0.026|STANDARD_DEVIATION|0.62|<|0.0001|TWO_SIDED|95.0|-0.08|0.13||One-side significance level = 0.025|t-test, 1 sided|||||0.13|-0.08|<0.0001
72334833|NCT02063867|144192504|SUPERIORITY|||||||0.17|||||||Mixed Models Analysis|Assessed if hazard ratio between intervention vs baseline periods differs between study groups, accounting for clustering within hospitals||||||0.17
72334834|NCT02063867|144192505|SUPERIORITY|||||||0.16|||||||Mixed Models Analysis|Assessed if hazard ratio between intervention vs baseline periods differs between study groups, accounting for clustering within hospitals||||||0.16
72334835|NCT02063867|144192506|SUPERIORITY|||||||0.43|||||||Mixed Models Analysis|Assessed if hazard ratio between intervention vs baseline periods differs between study groups, accounting for clustering within hospitals||||||0.43
72334836|NCT02063867|144192513|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|Assessed if hazard ratio between intervention vs baseline periods differs between study groups, accounting for clustering within hospitals||||||<0.001
72334837|NCT02063867|144192514|SUPERIORITY|||||||0.0126||||||Remains significant after adjusting for multiple comparisons|Mixed Models Analysis|Assessed if hazard ratio between intervention vs baseline periods differs between study groups, accounting for clustering within hospitals||||||0.0126
72334838|NCT02063867|144192515|SUPERIORITY|||||||0.002||||||Remained significant after adjusting for multiple comparisons|Mixed Models Analysis|Assessed if hazard ratio between intervention vs baseline periods differs between study groups, accounting for clustering within hospitals||||||0.002
72334839|NCT02063867|144192516|SUPERIORITY|||||||0.0032||||||Remained significant after adjusting for multiple comparisons|Mixed Models Analysis|Assessed if hazard ratio between intervention vs baseline periods differs between study groups, accounting for clustering within hospitals||||||0.0032
72334840|NCT04470908|144192520|OTHER|Estimate the geometric least square mean ratio of Zanubrutinib vs Zanubrutinib + Rifabutin|Ratio of Geometric Least Squares Means|0.566|||||TWO_SIDED|90.0|0.525|0.61||||||||0.610|0.525|
72334841|NCT04470908|144192521|OTHER|Estimate the geometric least square mean ratio of Zanubrutinib vs Zanubrutinib + Rifabutin|Ratio of Geometric Least Squares Means|0.56|||||TWO_SIDED|90.0|0.532|0.589||||||||0.589|0.532|
72334842|NCT04470908|144192522|OTHER|Estimate the geometric least square mean ratio of Zanubrutinib vs Zanubrutinib + Rifabutin|Ratio of Geometric Least Squares Means|0.518|||||TWO_SIDED|90.0|0.441|0.608||||||||0.608|0.441|
72334843|NCT04376684|144192529|OTHER||Odds Ratio (OR)|1.32||||0.0456|TWO_SIDED|95.0|0.96|1.82||p-value is from a one-sided test.|Regression, Logistic||Analysis performed using logistic regression adjusted for treatment, and both clinical status at Baseline and age group as randomized. Missing data was imputed with monotone discriminant multiple imputation assuming data is missing at random.|||1.82|0.96|0.0456
72334844|NCT04376684|144192530|OTHER||Odds Ratio (OR)|1.04||||0.8574|TWO_SIDED|95.0|0.67|1.61||p-value is generated from a two-sided test.|Regression, Logistic||Analysis performed using logistic regression adjusted for treatment, age, and both clinical status at Baseline and sex as randomized. Missing data was imputed with monotone logistic multiple imputation assuming data is missing at random.|||1.61|0.67|0.8574
72334845|NCT04376684|144192531|OTHER||Odds Ratio (OR)|0.86||||0.2057|TWO_SIDED|95.0|0.61|1.22||p-value is from a one-sided test.|Regression, Logistic||Analysis performed using logistic regression adjusted for treatment, and both clinical status at Baseline and age group as randomized. Missing data was imputed with monotone discriminant multiple imputation assuming data is missing at random.|||1.22|0.61|0.2057
72334846|NCT04376684|144192532|OTHER||Odds Ratio (OR)|0.79||||0.3061|TWO_SIDED|95.0|0.5|1.24||p-value is generated from a two-sided test.|Regression, Logistic||Analysis performed using logistic regression adjusted for treatment, age, and both clinical status at Baseline and sex as randomized. Missing data was imputed with monotone logistic multiple imputation assuming data is missing at random.|||1.24|0.50|0.3061
72334847|NCT04376684|144192533|OTHER||Odds Ratio (OR)|0.91||||0.6665|TWO_SIDED|95.0|0.59|1.41||p-value is generated from a two-sided test.|Regression, Logistic||Analysis performed using logistic regression adjusted for treatment, age, and both clinical status at Baseline and sex as randomized. Missing data was imputed with monotone logistic multiple imputation assuming data is missing at random.|||1.41|0.59|0.6665
72334848|NCT04376684|144192534|OTHER||Hazard Ratio (HR)|0.88||||0.1942|TWO_SIDED|95.0|0.65|1.18||p-value is from a one-sided test.|Regression, Cox||Model adjusted analysis performed using a Cox proportional hazards model adjusted by treatment, clinical status at Baseline as randomized and age group as randomized.|||1.18|0.65|0.1942
72425600|NCT02875834|144362833|OTHER||Odds Ratio (OR)|18.1876|||<|0.001|TWO_SIDED|95.0|7.1591|46.2054|||Regression, Logistic|||||46.2054|7.1591|<0.001
72334849|NCT04376684|144192535|OTHER||Hazard Ratio (HR)|0.9||||0.5324|TWO_SIDED|95.0|0.65|1.24||p-value is generated from a two-sided test|Regression, Cox||Model adjusted analysis performed using a Cox proportional hazards model adjusted by treatment, clinical status at Baseline as randomized, sex as randomized and age.|||1.24|0.65|0.5324
72334850|NCT04376684|144192536|OTHER||Odds Ratio (OR)|1.09||||0.2871|TWO_SIDED|95.0|0.8|1.49||p-value is from a one-sided test.|Regression, Logistic||Analysis performed using logistic regression adjusted for treatment, and both clinical status at Baseline and age group as randomized. Missing data was imputed with monotone discriminant multiple imputation assuming data is missing at random.|||1.49|0.80|0.2871
72334851|NCT04376684|144192537|OTHER||Odds Ratio (OR)|1.16||||0.1754|TWO_SIDED|95.0|0.85|1.58||p-value is from a one-sided test.|Regression, Logistic||Analysis performed using logistic regression adjusted for treatment, and both clinical status at Baseline and age group as randomized. Missing data was imputed with monotone discriminant multiple imputation assuming data is missing at random.|||1.58|0.85|0.1754
72334852|NCT04376684|144192538|OTHER||Odds Ratio (OR)|1.29||||0.0616|TWO_SIDED|95.0|0.93|1.79||p-value is from a one-sided test.|Regression, Logistic||Analysis performed using logistic regression adjusted for treatment, and both clinical status at Baseline and age group as randomized. Missing data was imputed with monotone discriminant multiple imputation assuming data is missing at random.|||1.79|0.93|0.0616
72334853|NCT04376684|144192539|OTHER||Odds Ratio (OR)|1.17||||0.183|TWO_SIDED|95.0|0.84|1.63||p-value is from a one-sided test.|Regression, Logistic||Analysis performed using logistic regression adjusted for treatment, and both clinical status at Baseline and age group as randomized. Missing data was imputed with monotone discriminant multiple imputation assuming data is missing at random.|||1.63|0.84|0.1830
72334854|NCT04376684|144192540|OTHER||Odds Ratio (OR)|1.51||||0.0831|TWO_SIDED|95.0|0.95|2.39||p-value is generated from a two-sided test.|Regression, Logistic||Analysis performed using logistic regression adjusted for treatment, age, and both clinical status at Baseline and sex as randomized. Missing data was imputed with monotone logistic multiple imputation assuming data is missing at random.|||2.39|0.95|0.0831
72334855|NCT04376684|144192541|OTHER||Odds Ratio (OR)|1.29||||0.2557|TWO_SIDED|95.0|0.83|2.0||p-value is generated from a two-sided test.|Regression, Logistic||Analysis performed using logistic regression adjusted for treatment, age, and both clinical status at Baseline and sex as randomized. Missing data was imputed with monotone logistic multiple imputation assuming data is missing at random.|||2.00|0.83|0.2557
72334856|NCT04376684|144192542|OTHER||Odds Ratio (OR)|1.04||||0.856|TWO_SIDED|95.0|0.67|1.61||p-value is generated from a two-sided test.|Regression, Logistic||Analysis performed using logistic regression adjusted for treatment, age, and both clinical status at Baseline and sex as randomized. Missing data was imputed with monotone logistic multiple imputation assuming data is missing at random.|||1.61|0.67|0.8560
72334857|NCT04376684|144192543|OTHER||Odds Ratio (OR)|1.07||||0.7533|TWO_SIDED|95.0|0.69|1.66||p-value is generated from a two-sided test.|Regression, Logistic||Analysis performed using logistic regression adjusted for treatment, age, and both clinical status at Baseline and sex as randomized. Missing data was imputed with monotone logistic multiple imputation assuming data is missing at random.|||1.66|0.69|0.7533
72334858|NCT04376684|144192544|OTHER||Hazard Ratio (HR)|1.12||||0.0959|TWO_SIDED|95.0|0.95|1.32||p-value is from a one-sided test.|Regression, Cox||Model adjusted analysis performed using a Cox proportional hazards model adjusted by treatment, clinical status at Baseline as randomized and age group as randomized.|||1.32|0.95|0.0959
72334859|NCT04376684|144192545|OTHER||Hazard Ratio (HR)|1.12||||0.4421|TWO_SIDED|95.0|0.84|1.5||p-value is generated from a two-sided test.|Regression, Cox||Model adjusted analysis performed using a Cox proportional hazards model adjusted by treatment, clinical status at Baseline as randomized, sex as randomized and age.|||1.50|0.84|0.4421
72334860|NCT04376684|144192546|OTHER||Odds Ratio (OR)|1.14||||0.2814|TWO_SIDED|95.0|0.73|1.8||p-value is from a one-sided test.|Regression, Logistic||Analysis performed using logistic regression adjusted for treatment, and both clinical status at Baseline and age group as randomized. Missing data was imputed with monotone discriminant multiple imputation assuming data is missing at random.|||1.80|0.73|0.2814
72334861|NCT04376684|144192547|OTHER||Odds Ratio (OR)|1.04||||0.3901|TWO_SIDED|95.0|0.77|1.42||p-value is from a one-sided test.|Regression, Logistic||Analysis performed using logistic regression adjusted for treatment, and both clinical status at Baseline and age group as randomized. Missing data was imputed with monotone discriminant multiple imputation assuming data is missing at random.|||1.42|0.77|0.3901
72334862|NCT04376684|144192548|OTHER||Odds Ratio (OR)|1.01||||0.4763|TWO_SIDED|95.0|0.75|1.36||p-value is from a one-sided test.|Regression, Logistic||Analysis performed using logistic regression adjusted for treatment, and both clinical status at Baseline and age group as randomized. Missing data was imputed with monotone discriminant multiple imputation assuming data is missing at random.|||1.36|0.75|0.4763
72334863|NCT04376684|144192549|OTHER||Odds Ratio (OR)|1.14||||0.1973|TWO_SIDED|95.0|0.84|1.56||p-value is from a one-sided test.|Regression, Logistic||Analysis performed using logistic regression adjusted for treatment, and both clinical status at Baseline and age group as randomized. Missing data was imputed with monotone discriminant multiple imputation assuming data is missing at random.|||1.56|0.84|0.1973
72334864|NCT04376684|144192550|OTHER||Odds Ratio (OR)|1.21||||0.1173|TWO_SIDED|95.0|0.88|1.67||p-value is from a one-sided test.|Regression, Logistic||Analysis performed using logistic regression adjusted for treatment, and both clinical status at Baseline and age group as randomized. Missing data was imputed with monotone discriminant multiple imputation assuming data is missing at random.|||1.67|0.88|0.1173
72334865|NCT04376684|144192551|OTHER||Odds Ratio (OR)|3.98||||0.0037|TWO_SIDED|95.0|1.57|10.13||p-value is generated from a two-sided test.|Regression, Logistic||Analysis performed using logistic regression adjusted for treatment, age, and both clinical status at Baseline and sex as randomized. Missing data was imputed with monotone logistic multiple imputation assuming data is missing at random.|||10.13|1.57|0.0037
72334866|NCT04376684|144192552|OTHER||Odds Ratio (OR)|1.26||||0.3581|TWO_SIDED|95.0|0.77|2.06||p-value is generated from a two-sided test.|Regression, Logistic||Analysis performed using logistic regression adjusted for treatment, age, and both clinical status at Baseline and sex as randomized. Missing data was imputed with monotone logistic multiple imputation assuming data is missing at random.|||2.06|0.77|0.3581
72334867|NCT04376684|144192553|OTHER||Odds Ratio (OR)|0.99||||0.9621|TWO_SIDED|95.0|0.63|1.54||p-value is generated from a two-sided test.|Regression, Logistic||Analysis performed using logistic regression adjusted for treatment, age, and both clinical status at Baseline and sex as randomized. Missing data was imputed with monotone logistic multiple imputation assuming data is missing at random.|||1.54|0.63|0.9621
72334868|NCT04376684|144192554|OTHER||Odds Ratio (OR)|0.83||||0.4167|TWO_SIDED|95.0|0.54|1.29||p-value is generated from a two-sided test.|Regression, Logistic||Analysis performed using logistic regression adjusted for treatment, age, and both clinical status at Baseline and sex as randomized. Missing data was imputed with monotone logistic multiple imputation assuming data is missing at random.|||1.29|0.54|0.4167
72334869|NCT04376684|144192555|OTHER||Odds Ratio (OR)|0.81||||0.3408|TWO_SIDED|95.0|0.53|1.25||p-value is generated from a two-sided test.|Regression, Logistic||Analysis performed using logistic regression adjusted for treatment, age, and both clinical status at Baseline and sex as randomized. Missing data was imputed with monotone logistic multiple imputation assuming data is missing at random.|||1.25|0.53|0.3408
72334870|NCT04376684|144192556|OTHER||Hazard Ratio (HR)|1.02||||0.425|TWO_SIDED|95.0|0.85|1.23||p-value is from a one-sided test.|Regression, Cox||Model adjusted analysis performed using a Cox proportional hazards model adjusted by treatment, clinical status at Baseline as randomized and age group as randomized.|||1.23|0.85|0.4250
72334871|NCT04376684|144192557|OTHER||Hazard Ratio (HR)|1.13||||0.4774|TWO_SIDED|95.0|0.81|1.59||p-value is generated from a two-sided test.|Regression, Cox||Model adjusted analysis performed using a Cox proportional hazards model adjusted by treatment, clinical status at Baseline as randomized, sex as randomized and age.|||1.59|0.81|0.4774
72334872|NCT04376684|144192558|OTHER||Odds Ratio (OR)|0.4||||0.0119|TWO_SIDED|95.0|0.18|0.89||p-value is from a one-sided test.|Regression, Logistic||Analysis performed using logistic regression adjusted for treatment, age, and both clinical status at Baseline and sex as randomized. Missing data was imputed with monotone logistic multiple imputation assuming data is missing at random.|||0.89|0.18|0.0119
72334873|NCT04376684|144192559|OTHER||Hazard Ratio (HR)|1.02||||0.4404|TWO_SIDED|95.0|0.83|1.24||p-value is from a one-sided test.|Regression, Cox||Model adjusted analysis performed using a Cox proportional hazards model adjusted by treatment, clinical status at Baseline as randomized and age group as randomized.|||1.24|0.83|0.4404
72334874|NCT04376684|144192560|OTHER||Hazard Ratio (HR)|1.11||||0.6253|TWO_SIDED|95.0|0.72|1.72||p-value is generated from a two-sided test.|Regression, Cox||Model adjusted analysis performed using a Cox proportional hazards model adjusted by treatment, clinical status at Baseline as randomized, sex as randomized and age.|||1.72|0.72|0.6253
72334875|NCT04376684|144192561|OTHER||Hazard Ratio (HR)|1.11||||0.1078|TWO_SIDED|95.0|0.94|1.3||p-value is from a one-sided test.|Regression, Cox||Model adjusted analysis performed using a Cox proportional hazards model adjusted by treatment, clinical status at Baseline as randomized and age group as randomized.|||1.30|0.94|0.1078
72334876|NCT04376684|144192562|OTHER||Hazard Ratio (HR)|1.11||||0.114|TWO_SIDED|95.0|0.94|1.31||p-value is from a one-sided test.|Regression, Cox||Model adjusted analysis performed using a Cox proportional hazards model adjusted by treatment, clinical status at Baseline as randomized and age group as randomized.|||1.31|0.94|0.1140
72334877|NCT04376684|144192563|OTHER||Hazard Ratio (HR)|1.06||||0.7084|TWO_SIDED|95.0|0.8|1.4||p-value is generated from a two-sided test.|Regression, Cox||Model adjusted analysis performed using a Cox proportional hazards model adjusted by treatment, clinical status at Baseline as randomized, sex as randomized and age.|||1.40|0.80|0.7084
72334878|NCT04376684|144192564|OTHER||Hazard Ratio (HR)|1.13||||0.4085|TWO_SIDED|95.0|0.84|1.52||p-value is generated from a two-sided test.|Regression, Cox||Model adjusted analysis performed using a Cox proportional hazards model adjusted by treatment, clinical status at Baseline as randomized, sex as randomized and age.|||1.52|0.84|0.4085
72334879|NCT01974206|144192589|OTHER||Common Odds Ratio|0.79||||0.307|TWO_SIDED|90.0|0.43|1.47||P-value (1-sided) of the Exact Cochran-Mantel-Haenszel method adjusted odds ratio stratified by randomization group.|Cochran-Mantel-Haenszel|||The Cochran-Mantel-Haenszel (CMH) estimate of the common odds ratio (ASP0113 vs placebo) stratified by randomization strata, and the 90% CIs of the CMH odds ratio stratified by randomization group.||1.47|0.43|0.307
72334880|NCT01974206|144192590|OTHER||Common Odds Ratio|0.99||||0.576|TWO_SIDED|90.0|0.46|2.15||P-value (1-sided) of the Exact Cochran-Mantel-Haenszel method adjusted odds ratio stratified by randomization group.|Cochran-Mantel-Haenszel|||The exact Cochran-Mantel-Haenszel (CMH) estimate of the common odds ratio (ASP0113 vs placebo) stratified by randomization group, and the 90% CI of the exact CMH odds ratio stratified by randomization group.||2.15|0.46|0.576
72334881|NCT01974206|144192591|OTHER||Common Odds Ratio|0.88||||0.408|TWO_SIDED|90.0|0.48|1.59||P-value (1-sided) of the Exact Cochran-Mantel-Haenszel method adjusted odds ratio stratified by randomization group.|Cochran-Mantel-Haenszel|||The exact Cochran-Mantel-Haenszel (CMH) estimate of the common odds ratio (ASP0113 vs placebo) stratified by randomization group, and the 90% CI of the exact CMH odds ratio stratified by randomization group.||1.59|0.48|0.408
72334882|NCT01974206|144192592|OTHER||Common Odds Ratio|0.88||||0.419|TWO_SIDED|90.0|0.48|1.61||P-value (1-sided) of the Exact Cochran-Mantel-Haenszel method adjusted odds ratio stratified by randomization group.|Cochran-Mantel-Haenszel|||The exact Cochran-Mantel-Haenszel (CMH) estimate of the common odds ratio (ASP0113 vs placebo) stratified by randomization group, and the 90% CI of the exact CMH odds ratio stratified by randomization group.||1.61|0.48|0.419
72334883|NCT01974206|144192593|OTHER|||||||0.5||||||P-value (1-sided) of the Exact Cochran-Mantel-Haenszel method adjusted odds ratio stratified by randomization group.|Cochran-Mantel-Haenszel|||Exact Cochran-Mantel-Haenszel estimate of the common odds ratio could not be calculated as 100% of ASP0113 group showed graft survival, and this leads to having a value of 0 for the denominator for the ratio thus odds ratio is not estimable. The 90% CI (2-sided) values for the odds ratio are 0.11 to NA, where NA is an infinity value.||||0.5
72334884|NCT02118766|144192599|SUPERIORITY_OR_OTHER|||||||0.038|||||||Regression, Logistic|||||||0.038
72334885|NCT03219034|144192608|SUPERIORITY||Median Difference (Final Values)|3.8||||0.152|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Cross-over design: Median differences between oral appliances at the end of the first 4-week leg of the study (T2). The hypothesis tested was that REI would be lowered more with Appliance A than B.||||0.152
72334886|NCT02136680|144192631|SUPERIORITY||Regression Coefficient|0.046||||0.4|TWO_SIDED||||||Regression, Linear|||Change in Self-Esteem from Baseline to First Follow-up: Intervention Group vs. Control Group||||0.400
72334887|NCT02136680|144192631|SUPERIORITY||Regression Coefficient|0.119||||0.022|TWO_SIDED||||||Regression, Linear|||Change in Self-Esteem from Baseline to Second Follow-up: Intervention Group vs. Control Group||||0.022
72334888|NCT02136680|144192631|SUPERIORITY||Regression Coefficient|-0.003||||0.347|TWO_SIDED||||||Regression, Linear|||Change in Self-Esteem from First Follow-up to Second Follow-up: Intervention Group vs. Control Group||||0.347
72334889|NCT02136680|144192632|SUPERIORITY||Regression Coefficient|-0.003||||0.959|TWO_SIDED||||||Regression, Linear|||Change in Global QOL from Baseline to First Follow-up: Intervention Group vs. Control Group||||0.959
72334890|NCT02136680|144192632|SUPERIORITY||Regression Coefficient|0.143||||0.021|TWO_SIDED||||||Regression, Linear|||Change in Global QOL from Baseline to Second Follow-up: Intervention Group vs. Control Group||||0.021
72334891|NCT02136680|144192632|SUPERIORITY||Regression Coefficient|0.048||||0.454|TWO_SIDED||||||Regression, Linear|||Change in Global QOL from First Follow-up to Second Follow-up: Intervention Group vs. Control Group||||0.454
72334892|NCT02136680|144192632|SUPERIORITY||Regression Coefficient|-0.015||||0.774|TWO_SIDED||||||Regression, Linear|||Change in Summary QOL from Baseline to First Follow-up||||0.774
72334893|NCT02136680|144192632|SUPERIORITY||Regression Coefficient|0.137||||0.018|TWO_SIDED||||||Regression, Linear|||Change in Summary QOL from Baseline to Second Follow-up: Intervention Group vs. Control Group||||0.018
72334894|NCT02136680|144192632|SUPERIORITY||Regression Coefficient|0.051||||0.362|TWO_SIDED||||||Regression, Linear|||Change in Summary QOL from First Follow-up to Second Follow-up: Intervention Group vs. Control Group||||0.362
72334895|NCT02136680|144192633|SUPERIORITY||Regression Coefficient|-0.072||||0.213|TWO_SIDED||||||Regression, Linear|||Change in Palliative Outcomes from Baseline to First Follow-up: Intervention Group vs. Control Group||||0.213
72334896|NCT02136680|144192633|SUPERIORITY||Regression Coefficient|0.037||||0.561|TWO_SIDED||||||Regression, Linear|||Change in Palliative Outcomes from Baseline to Second Follow-up: Intervention Group vs. Control Group||||0.561
72334897|NCT02136680|144192633|SUPERIORITY|Change in Palliative Outcomes from First Follow-up to Second Follow-up: Intervention Group vs. Control Group|Regression Coefficient|0.165||||0.008|TWO_SIDED||||||Regression, Linear|||||||0.008
72334898|NCT01846299|144192679|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.78|STANDARD_ERROR_OF_MEAN|1.203||0.0111|TWO_SIDED|95.0|0.4|5.16|||Mixed Models Analysis|||||5.16|0.40|0.0111
72334899|NCT01457014|144192695|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|p values have undergone Bonferroni adjustment for Central Apnea Index (CAI), Obstructive Apnea Index (OAI) and Hypopnea Index (HI)||||||<0.001
72334900|NCT01457014|144192696|SUPERIORITY_OR_OTHER|||||||0.627|TWO_SIDED|||||p value has undergone Bonferroni adjustment. P-Value applies to Av. 02 saturation|Wilcoxon (Mann-Whitney)|p value has undergone Bonferroni adjustment||||||0.627
72334901|NCT01457014|144192697|SUPERIORITY_OR_OTHER|||||||0.161|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.161
72334902|NCT01357161|144192698|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.63||||0.08|TWO_SIDED|80.0|0.45|0.89|||Cox proportional hazards model|||A stratified \[number of prior platinum based regimens (1 vs. 2 and 3), time since last platinum based therapy (\<12 months vs. ≥12 months)\] Cox proportional hazards model, with Efron method of tie handling, was used to assess the magnitude of the treatment difference between the treatment arms. The p-value from the score test was used in the significance test and the hazard ratio (MK-1775 versus Placebo) and its 95% confidence interval from the same Cox model was reported.||0.89|0.45|0.080
72334903|NCT01357161|144192700|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.55||||0.03|TWO_SIDED|80.0|0.39|0.79|||Cox proportional hazards model|||A stratified \[number of prior platinum based regimens (1 vs. 2 and 3), time since last platinum based therapy (\<12 months vs. ≥12 months)\] Cox proportional hazards model, with Efron method of tie handling, was used to assess the magnitude of the treatment difference between the treatment arms. The p-value from the score test was used in the significance test and the hazard ratio (MK-1775 versus Placebo) and its 95% confidence interval from the same Cox model was reported.||0.79|0.39|0.030
72334904|NCT01357161|144192702|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentages|3.3|||||TWO_SIDED|95.0|-2.9|11.4||||||P-values and 95% confidence intervals were calculated using the Miettinen and Nurminen method for between-treatment differences (MK-1775 vs. placebo) in the percentage of participants with events.||11.4|-2.9|
72334905|NCT01357161|144192703|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentages|-1.3|||||TWO_SIDED|95.0|-16.2|13.6||||||P-values and 95% confidence intervals were calculated using the Miettinen and Nurminen method for between-treatment differences (MK-1775 vs. placebo) in the percentage of participants with events.||13.6|-16.2|
72334906|NCT01357161|144192704|SUPERIORITY_OR_OTHER_LEGACY||Difference in Response Rat|5.2||||0.5247|TWO_SIDED|95.0|-10.9|21.1|||Miettinen and Nurminen's Method|||Stratified Miettinen and Nurminen's method with a two-sided p-Value for testing was used for comparison of the ORRs between the treatment groups in Part 2 portion of the study. A 95% confidence interval (CI) for the difference in response rates was provided.||21.1|-10.9|0.5247
72334907|NCT01357161|144192705|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.15||||0.8|TWO_SIDED|95.0|0.4|3.34|||Cox proportional hazards model|||A stratified \[number of prior platinum based regimens (1 vs. 2 and 3), time since last platinum based therapy (\<12 months vs. ≥12 months)\] Cox proportional hazards model, with Efron method of tie handling, was used to assess the magnitude of the treatment difference between the treatment arms. The p-value from the score test was used in the significance test and the hazard ratio (MK-1775 versus Placebo) and its 95% confidence interval from the same Cox model was reported.||3.34|0.40|0.800
72334908|NCT02825420|144192709|SUPERIORITY|||||||0.007|||||||Log Rank|||||||0.007
72334909|NCT02825420|144192710|SUPERIORITY|||||||0.58|||||||Log Rank|||||||0.58
72334910|NCT02825420|144192711|SUPERIORITY|||||||0.62|||||||Log Rank|||||||0.62
72334911|NCT02825420|144192713|SUPERIORITY|||||||0.01|||||||Chi-squared|||||||0.010
72334912|NCT02825420|144192715|SUPERIORITY|||||||0.048|||||||Log Rank|||||||0.048
72334913|NCT02825420|144192716|SUPERIORITY|||||||0.51|||||||Log Rank|||||||0.51
72334914|NCT01328041|144192788|SUPERIORITY_OR_OTHER||T distribution|-1.432|||<|0.001|TWO_SIDED|95.0|-1.52|-1.343||The P value was derived by the null hypothesis testing of no change from Baseline in HIV-1 RNA at Day 8 at the two-sided 5% significance level using a single sample t-test.|t-test, 2 sided|||||-1.343|-1.520|<0.001
72334915|NCT01328041|144192789|SUPERIORITY_OR_OTHER||percentage of participants|69.0|||||TWO_SIDED|95.0|62.0|76.0|||||The estimated value represents the percentage of participants with HIV-1 RNA less than 50 copies/mL at Week 24.|||76|62|
72334916|NCT01328041|144192790|SUPERIORITY_OR_OTHER||percentage of participants|63.0|||||TWO_SIDED|95.0|56.0|70.0|||||The estimated value represents the percentage of participants with HIV-1 RNA less than 50 copies/mL at Week 48.|||70|56|
72334917|NCT02688088|144192810|SUPERIORITY||Ratio of Geometric LS Means|1.01|||||TWO_SIDED|90.0|0.965|1.06||||||||1.06|0.965|
72425601|NCT02875834|144362835|OTHER||Mean Difference (Final Values)|7.266|||<|0.001|TWO_SIDED|95.0|4.318|10.214|||Regression, Linear|||Results derived from a linear regression model with the following covariates: treatment group; baseline S-K values (Open-label phase and Randomized treatment phase); baseline eGFR; age category; country; baseline RAAS inhibitor, chronic kidney disease, heart failure, and diabetes mellitus statuses.||10.214|4.318|<0.001
72425602|NCT02875834|144362835|OTHER||Mean Difference (Final Values)|12.079|||<|0.001|TWO_SIDED|95.0|9.118|15.04|||Regression, Linear|||||15.040|9.118|<0.001
72425603|NCT02875834|144362838|OTHER||Hazard Ratio (HR)|0.443|||<|0.001|TWO_SIDED|95.0|0.2954|0.6631|||Regression, Cox|||Results derived from a Cox Proportional Hazards model with the following covariates: treatment group, both baseline S-K values (48-hours open-label initial phase and double-blind randomized phase), baseline eGFR, age category (\<55, 55-64, \>=65 years), country, baseline RAAS inhibitor, chronic kidney, disease heart failure, and diabetes mellitus statuses.||0.6631|0.2954|<0.001
72425604|NCT02875834|144362838|OTHER||Hazard Ratio (HR)|0.158|||<|0.001|TWO_SIDED|95.0|0.0992|0.2508|||Regression, Cox|||||0.2508|0.0992|<0.001
72425605|NCT01302938|144362856|SUPERIORITY_OR_OTHER_LEGACY||Least squares (LS) mean difference|-1.6|STANDARD_ERROR_OF_MEAN|1.0|||TWO_SIDED|95.0|-3.9|0.6||||||Change at Week 12: Analysis was performed using an analysis of covariance (ANCOVA) with term for treatment with baseline value as a covariate.||0.6|-3.9|
72425606|NCT01302938|144362857|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|29.4|STANDARD_ERROR_OF_MEAN|35.4|||TWO_SIDED|95.0|-47.8|106.6||||||Change at Week 1: Analysis was performed using an ANCOVA with term for treatment with baseline value as a covariate.||106.6|-47.8|
72425607|NCT01302938|144362857|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|28.0|STANDARD_ERROR_OF_MEAN|38.9|||TWO_SIDED|95.0|-55.4|111.4||||||Change at Week 4: Analysis was performed using an ANCOVA with term for treatment with baseline value as a covariate.||111.4|-55.4|
72334918|NCT02688088|144192811|SUPERIORITY||Ratio of Geometric LS Means|0.935|||||TWO_SIDED|90.0|0.871|1.0||||||||1.00|0.871|
72334919|NCT02688088|144192812|SUPERIORITY||Ratio of Geometric LS Means|1.05|||||TWO_SIDED|90.0|0.898|1.22||||||||1.22|0.898|
72334920|NCT02688088|144192813|SUPERIORITY||Ratio of Geometric LS Means|0.845|||||TWO_SIDED|90.0|0.76|0.94||||||||0.940|0.760|
72334921|NCT02688088|144192814|SUPERIORITY||Ratio of Geometric LS Means|1.56|||||TWO_SIDED|90.0|1.35|1.81||||||||1.81|1.35|
72334922|NCT02688088|144192815|SUPERIORITY||Ratio of Geometric LS Means|1.04|||||TWO_SIDED|90.0|0.956|1.13||||||||1.13|0.956|
72334923|NCT02688088|144192816|SUPERIORITY||Mean Difference (Final Values)|0.976|||||TWO_SIDED|90.0|0.805|1.18||||||||1.18|0.805|
72334924|NCT02688088|144192817|SUPERIORITY||Ratio of Geometric LS Means|0.867|||||TWO_SIDED|90.0|0.775|0.972||||||||0.972|0.775|
72334925|NCT05275010|144192828|EQUIVALENCE|The null hypothesis will be rejected and bioequivalence will be concluded if the bounds of the 90% CI for the geometric mean ratio of the AUC0-62 values for pertuzumab by administration using OBDS (Arm 2) relative to the handheld syringe (Arm 1) are entirely contained within standard bioequivalence margins (0.8 to 1.25).|Geometric Mean Ratio (GMR)|1.0|||||TWO_SIDED|90.0|0.93|1.08|||||GMR of test treatment group (Arm 2: PH FDC SC using OBDS) to reference treatment group (Arm 1: PH FDC SC using handheld syringe).|||1.08|0.93|
72334926|NCT05275010|144192829|EQUIVALENCE|The null hypothesis will be rejected and bioequivalence will be concluded if the bounds of the 90% CI for the geometric mean ratio of the AUC0-62 values for trastuzumab by administration using OBDS (Arm 2) relative to the handheld syringe (Arm 1) are entirely contained within standard bioequivalence margins (0.8 to 1.25).|Geometric Mean Ratio (GMR)|1.0|||||TWO_SIDED|90.0|0.93|1.09|||||GMR of test treatment group (Arm 2: PH FDC SC using OBDS) to reference treatment group (Arm 1: PH FDC SC using handheld syringe).|||1.09|0.93|
72425608|NCT01302938|144362857|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|43.0|STANDARD_ERROR_OF_MEAN|31.4|||TWO_SIDED|95.0|-24.2|110.3||||||Change at Week 12: Analysis was performed using an ANCOVA with term for treatment with baseline value as a covariate.||110.3|-24.2|
72425609|NCT01302938|144362858|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|0.17|||||TWO_SIDED|95.0|-0.67|1.67||||||Change at Week 1: Non-parametric Hodges-Lehmann's method was used to obtain median difference and 95 percent (%) confidence intervals (CI).||1.67|-0.67|
72425610|NCT01302938|144362858|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|0.58|||||TWO_SIDED|95.0|-1.0|1.83||||||Change at Week 4: Non-parametric Hodges-Lehmann's method was used to obtain median difference and 95% CI.||1.83|-1.00|
72425611|NCT01302938|144362858|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-0.5|||||TWO_SIDED|95.0|-3.0|1.0||||||Change at Week 12: Non-parametric Hodges-Lehmann's method was used to obtain median difference and 95% CI.||1.00|-3.00|
72425612|NCT01302938|144362859|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.3|STANDARD_ERROR_OF_MEAN|0.7|||TWO_SIDED|95.0|-1.3|1.8||||||Change at Week 1: Analysis was performed using an ANCOVA with term for treatment with baseline value as a covariate.||1.8|-1.3|
72425613|NCT01302938|144362859|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.7|||TWO_SIDED|95.0|-2.2|0.9||||||Change at Week 4: Analysis was performed using an ANCOVA with term for treatment with baseline value as a covariate.||0.9|-2.2|
72425614|NCT01302938|144362862|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.6|STANDARD_ERROR_OF_MEAN|0.6|||TWO_SIDED|95.0|-0.8|1.9||||||Change at Week 1: Analysis was performed using an ANCOVA with term for treatment with baseline value as a covariate.||1.9|-0.8|
72425615|NCT01302938|144362862|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.4|STANDARD_ERROR_OF_MEAN|1.1|||TWO_SIDED|95.0|-3.7|0.8||||||Change at Week 4: Analysis was performed using an ANCOVA with term for treatment with baseline value as a covariate.||0.8|-3.7|
72334927|NCT05275010|144192830|EQUIVALENCE|The null hypothesis will be rejected and bioequivalence will be concluded if the bounds of the 90% CI for the geometric mean ratio of the Cmax values for pertuzumab by administration using OBDS (Arm 2) relative to the handheld syringe (Arm 1) are entirely contained within standard bioequivalence margins (0.8 to 1.25).|Geometric Mean Ratio (GMR)|1.04|||||TWO_SIDED|90.0|0.96|1.12|||||GMR of test treatment group (Arm 2: PH FDC SC using OBDS) to reference treatment group (Arm 1: PH FDC SC using handheld syringe).|||1.12|0.96|
72334928|NCT05275010|144192831|EQUIVALENCE|The null hypothesis will be rejected and bioequivalence will be concluded if the bounds of the 90% CI for the geometric mean ratio of the Cmax values for trastuzumab by administration using OBDS (Arm 2) relative to the handheld syringe (Arm 1) are entirely contained within standard bioequivalence margins (0.8 to 1.25).|Geometric Mean Ratio (GMR)|1.04|||||TWO_SIDED|90.0|0.95|1.13|||||GMR of test treatment group (Arm 2: PH FDC SC using OBDS) to reference treatment group (Arm 1: PH FDC SC using handheld syringe).|||1.13|0.95|
72334929|NCT02449889|144192881|NON_INFERIORITY|Treatment comparisons were done in a sequential manner. First non-inferiority (NI) was tested for HP-hCG IM compared to rhCG SC (lower limit of the 95% confidence interval (CI) \> -3.0). If NI was demonstrated, NI was also to be tested for HP-hCG SC compared to rhCG SC.|Mean Difference (Final Values)|0.6|||||TWO_SIDED|95.0|-0.6|1.8|||||ANOVA with treatment, stratum (\<10 or ≥10 follicles with a diameter ≥12 mm), and site as fixed factors.|Mean number of oocytes retrieved for the treatment comparison of HP-hCG IM versus rhCG SC||1.8|-0.6|
72334930|NCT02449889|144192881|NON_INFERIORITY|As step 2 in the pre-specified sequential testing, NI was tested for HP-hCG SC compared to rhCG SC.|Mean Difference (Final Values)|0.8|||||TWO_SIDED|95.0|-0.5|2.0|||||ANOVA with treatment, stratum (\<10 or ≥10 follicles with a diameter ≥12 mm), and site as fixed factors.|Mean number of oocytes retrieved for the treatment comparison of HP-hCG SC versus rhCG SC||2.0|-0.5|
72334931|NCT02449889|144192882|NON_INFERIORITY|Pre-specified supportive endpoint analyzed in a similar manner as the primary endpoint.|Mean Difference (Final Values)|0.4|||||TWO_SIDED|95.0|-0.6|1.5|||||ANOVA with treatment, stratum (\<10 or ≥10 follicles with a diameter ≥12 mm), and site as fixed factors.|Number of MII oocytes retrieved for the treatment comparison of HP-hCG IM versus rhCG SC||1.5|-0.6|
72334932|NCT02449889|144192882|NON_INFERIORITY|Pre-specified supportive endpoint analyzed in a similar manner as the primary endpoint.|Mean Difference (Final Values)|0.6|||||TWO_SIDED|95.0|-0.4|1.6|||||ANOVA with treatment, stratum (\<10 or ≥10 follicles with a diameter ≥12 mm), and site as fixed factors.|Number of Mll oocytes retrieved for the treatment comparison of HP-hCG SC versus rhCG SC||1.6|-0.4|
72334933|NCT02449889|144192883|NON_INFERIORITY|Pre-specified supportive endpoint analyzed in a similar manner as the primary endpoint.|Mean Difference (Final Values)|0.3|||||TWO_SIDED|95.0|-0.6|1.3|||||ANOVA with treatment, stratum (\<10 or ≥10 follicles with a diameter ≥12 mm), and site as fixed factors.|Number of fertilized (2 pronuclei (2PN)) oocytes for the treatment comparison of HP-hCG IM versus rhCG SC||1.3|-0.6|
72334934|NCT02449889|144192883|NON_INFERIORITY|Pre-specified supportive endpoint analyzed in a similar manner as the primary endpoint.|Mean Difference (Final Values)|0.5|||||TWO_SIDED|95.0|-0.5|1.4|||||ANOVA with treatment, stratum (\<10 or ≥10 follicles with a diameter ≥12 mm), and site as fixed factors.|Number of fertilized (2 pronuclei (2PN)) oocytes for the treatment comparison of HP-hCG SC versus rhCG SC.||1.4|-0.5|
72334935|NCT03327220|144192888|SUPERIORITY||Difference in Means|1.3||||0.0841|TWO_SIDED|95.0|-0.6|3.2||p-value was calculated from a one-sided, two-sample t-test.|t-test, 1 sided|||Testing null hypothesis that true iovera° mean was greater than or equal to the true standard of care mean versus the alternative hypothesis that true iovera° mean was less than true standard of care mean.||3.2|-0.6|0.0841
72334936|NCT03327220|144192889|NON_INFERIORITY|The objective met if the t-test for non-inferiority was statistically significant using a one-sided α = 0.025 level of statistical significance.|Difference in Means|1.9|||<|0.0001|TWO_SIDED|95.0|-2.3|6.1||p-value was calculated from a one-sided, two-sample t-test.|t-test, 1 sided|||Testing null hypothesis that Standard of Care mean minus the iovera° mean was greater than or equal to non-inferiority margin of 14 versus alternative hypothesis that difference in means was less than 14.||6.1|-2.3|<0.0001
72334937|NCT03327220|144192890|SUPERIORITY||Difference in Means|0.5||||0.0946|TWO_SIDED|95.0|-0.2|1.2||p-value was calculated from a one-sided, two-sample t-test.|t-test, 1 sided|||Pain in the Past 7 days - Testing the null hypothesis that the iovera° mean was less than or equal to the Standard of Care mean versus the alternative hypothesis that the iovera° mean was greater than the Standard of Care mean.||1.2|-0.2|0.0946
72334938|NCT03327220|144192890|SUPERIORITY|Pain Right Now - Testing the null hypothesis that the iovera° mean was less than or equal to the Standard of Care mean versus the alternative hypothesis that the iovera° mean was greater than the Standard of Care mean.|Difference in Means|0.4||||0.2204|TWO_SIDED|95.0|-0.6|1.3||p-value was calculated from a one-sided, two-sample t-test,|t-test, 1 sided|||||1.3|-0.6|0.2204
72334939|NCT03327220|144192891|SUPERIORITY||Difference in Means|-0.8||||0.3231|TWO_SIDED|95.0|-4.0|2.5||p-value was calculated from a one-sided, two-sample t-test.|t-test, 1 sided|||Testing the null hypothesis that the iovera° mean was less than or equal to the Standard of Care mean versus the alternative hypothesis that the iovera° mean was greater than the Standard of Care mean.||2.5|-4.0|0.3231
72334940|NCT03077438|144192934|NON_INFERIORITY|95% confidence interval (CI) of the difference was calculated from the Wilson Score Method without continuity correction. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference between the 2 percentages was \>-10%.|Percentage Difference|7.6|||||TWO_SIDED|95.0|1.1|14.0||||||Serogroup A||14|1.1|
72334941|NCT03077438|144192934|NON_INFERIORITY|95% CI of the difference was calculated from the Wilson Score Method without continuity correction. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference between the 2 percentages was \>-10%.|Percentage Difference|47.4|||||TWO_SIDED|95.0|42.2|52.2||||||Serogroup C||52.2|42.2|
72334942|NCT03077438|144192934|NON_INFERIORITY|95% CI of the difference was calculated from the Wilson Score Method without continuity correction. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference between the 2 percentages was \>-10%.|Percentage Difference|12.2|||||TWO_SIDED|95.0|7.7|16.7||||||Serogroup Y||16.7|7.7|
72334943|NCT03077438|144192934|NON_INFERIORITY|95% CI of the difference was calculated from the Wilson Score Method without continuity correction. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference between the 2 percentages was \>-10%.|Percentage Difference|14.8|||||TWO_SIDED|95.0|8.9|20.5||||||Serogroup W||20.5|8.9|
72334944|NCT03077438|144192935|OTHER||GMT Ratio|1.09|||||TWO_SIDED|95.0|0.91|1.32||||||Serogroup A||1.32|0.91|
72334945|NCT03077438|144192935|OTHER||GMT Ratio|14.0|||||TWO_SIDED|95.0|11.3|17.3||||||Serogroup C||17.3|11.3|
72334946|NCT03077438|144192935|OTHER||GMT Ratio|1.58|||||TWO_SIDED|95.0|1.31|1.9||||||Serogroup Y||1.9|1.31|
72334947|NCT03077438|144192935|OTHER||GMT Ratio|1.43|||||TWO_SIDED|95.0|1.21|1.69||||||Serogroup W||1.69|1.21|
72334948|NCT03077438|144192936|OTHER||GMT Ratio|1.14|||||TWO_SIDED|95.0|0.883|1.47||||||Serogroup A||1.47|0.883|
72334949|NCT03077438|144192936|OTHER||GMT Ratio|17.4|||||TWO_SIDED|95.0|13.4|22.6||||||Serogroup C||22.6|13.4|
72334950|NCT03077438|144192936|OTHER||GMT Ratio|1.38|||||TWO_SIDED|95.0|1.07|1.78||||||Serogroup Y||1.78|1.07|
72334951|NCT03077438|144192936|OTHER||GMT Ratio|1.43|||||TWO_SIDED|95.0|1.12|1.83||||||Serogroup W||1.83|1.12|
72334952|NCT03077438|144192937|OTHER||GMT Ratio|1.06|||||TWO_SIDED|95.0|0.816|1.38||||||Serogroup A||1.38|0.816|
72334953|NCT03077438|144192937|OTHER||GMT Ratio|11.5|||||TWO_SIDED|95.0|8.24|16.0||||||Serogroup C||16|8.24|
72334954|NCT03077438|144192937|OTHER||GMT Ratio|1.84|||||TWO_SIDED|95.0|1.41|2.38||||||Serogroup Y||2.38|1.41|
72334955|NCT03077438|144192937|OTHER||GMT Ratio|1.45|||||TWO_SIDED|95.0|1.16|1.82||||||Serogroup W||1.82|1.16|
72334956|NCT03077438|144192938|OTHER||Percentage Difference|7.6|||||TWO_SIDED|95.0|-1.6|16.7||||||Serogroup A||16.7|-1.6|
72334957|NCT03077438|144192938|OTHER||Percentage Difference|51.1|||||TWO_SIDED|95.0|43.5|57.8||||||Serogroup C||57.8|43.5|
72334958|NCT03077438|144192938|OTHER||Percentage Difference|11.2|||||TWO_SIDED|95.0|4.2|18.1||||||Serogroup Y||18.1|4.2|
72334959|NCT03077438|144192938|OTHER||Percentage Difference|12.5|||||TWO_SIDED|95.0|3.9|20.9||||||Serogroup W||20.9|3.9|
72334960|NCT03077438|144192939|OTHER||Percentage Difference|7.7|||||TWO_SIDED|95.0|-1.3|16.6||||||Serogroup A||16.6|-1.3|
72334961|NCT03077438|144192939|OTHER||Percentage Difference|44.0|||||TWO_SIDED|95.0|36.8|50.6||||||Serogroup C||50.6|36.8|
72334962|NCT03077438|144192939|OTHER||Percentage Difference|13.3|||||TWO_SIDED|95.0|7.6|19.2||||||Serogroup Y||19.2|7.6|
72334963|NCT03077438|144192939|OTHER||Percentage Difference|17.2|||||TWO_SIDED|95.0|9.4|24.7||||||Serogroup W||24.7|9.4|
72334964|NCT04392141|144192944|EQUIVALENCE|equivalence of odds of death between both groups|Odds Ratio (OR)|9.87||||0.0318|TWO_SIDED|95.0|1.16|83.89|||Fisher Exact|||||83.89|1.16|0.0318
72334965|NCT04392141|144192945|EQUIVALENCE|equivalence of SpO2 percentage between admission and discharge phases|Mean Difference (Final Values)|-5.5||||0.0001|TWO_SIDED|95.0|-7.03|-3.96|||t-test, 2 sided|Paired T-test||Statistical comparison of SpO2 (%) between admission and discharge times in standard treatment group||-3.96|-7.03|0.0001
72334966|NCT04392141|144192945|EQUIVALENCE|equivalence of SpO2 percentage between admission and discharge phases|Mean Difference (Final Values)|-2.55||||0.0001|TWO_SIDED|95.0|-3.28|-1.81|||t-test, 2 sided|Paired T-test||Statistical comparison of SpO2 % between admission and discharge times in the Colchicine and Herbal Phenolic Monoterpene Fractions treatment||-1.81|-3.28|0.0001
72334967|NCT04392141|144192946|EQUIVALENCE|equivalence of means of the length of hospitalization between both groups|Mean Difference (Final Values)|2.22||||0.0001|TWO_SIDED|95.0|1.63|2.8|||Wilcoxon (Mann-Whitney)|||||2.80|1.63|0.0001
72334968|NCT04392141|144192947|EQUIVALENCE|equivalence of mean of lymphocytes count between admission and discharge phases|Mean Difference (Final Values)|0.02||||0.8|TWO_SIDED|95.0|-0.136|0.176|||t-test, 2 sided|Paired T-test||Statistical comparison of lymphocytes count between admission and discharge times in standard treatment||0.176|-0.136|0.80
72334969|NCT04392141|144192947|EQUIVALENCE|equivalence of mean of lymphocytes count between admission and discharge phases|Mean Difference (Final Values)|-0.43||||0.0001|TWO_SIDED|95.0|-0.63|-0.23|||t-test, 2 sided|Paired T-test||Statistical comparison of lymphocytes count between admission and discharge times in Colchicine and Herbal Phenolic Monoterpene Fractions treatment||-0.23|-0.63|0.0001
72334970|NCT04392141|144192948|EQUIVALENCE|equivalence of mean of LDH between admission and discharge phases|Mean Difference (Final Values)|-26.06||||0.602|TWO_SIDED|95.0|-124.76|72.64|||t-test, 2 sided|Paired T-test||Statistical comparison of LDH between admission and discharge times in standard treatment||72.64|-124.76|0.602
72425616|NCT01302938|144362862|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-2.9|STANDARD_ERROR_OF_MEAN|1.5|||TWO_SIDED|95.0|-6.3|0.4||||||Change at Week 12: Analysis was performed using an ANCOVA with term for treatment with baseline value as a covariate.||0.4|-6.3|
72425617|NCT01302938|144362865|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-10.0|STANDARD_ERROR_OF_MEAN|10.8|||TWO_SIDED|95.0|-33.2|13.2||||||Change at Week 12: Analysis was performed using an ANCOVA with term for treatment with baseline value as a covariate.||13.2|-33.2|
72425618|NCT01302938|144362866|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|11.7|STANDARD_ERROR_OF_MEAN|8.6|||TWO_SIDED|95.0|-6.9|30.3||||||Change at Week 12; Coping Subscale: Analysis was performed using an ANCOVA with term for treatment with baseline value as a covariate.||30.3|-6.9|
72425619|NCT01302938|144362866|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|8.0|STANDARD_ERROR_OF_MEAN|11.4|||TWO_SIDED|95.0|-16.7|32.7||||||Change at Week 12; Concern Subscale: Analysis was performed using an ANCOVA with term for treatment with baseline value as a covariate.||32.7|-16.7|
72425620|NCT01302938|144362866|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|10.3|STANDARD_ERROR_OF_MEAN|10.9|||TWO_SIDED|95.0|-13.3|33.8||||||Change at Week 12; Sleep Subscale: Analysis was performed using an ANCOVA with term for treatment with baseline value as a covariate.||33.8|-13.3|
72425621|NCT01302938|144362866|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|9.0|STANDARD_ERROR_OF_MEAN|9.3|||TWO_SIDED|95.0|-11.0|29.0||||||Change at Week 12; Total HRQL Score: Analysis was performed using an ANCOVA with term for treatment with baseline value as a covariate.||29.0|-11.0|
72425622|NCT01302938|144362867|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|4.0|||||TWO_SIDED|95.0|-20.0|20.0||||||Change at Week 12; Social Subscale: Non-parametric Hodges-Lehmann's method was used to obtain median difference and 95% CI.||20.00|-20.00|
72425623|NCT01233609|144362878|SUPERIORITY||Mean Difference (Net)|-150.43|STANDARD_ERROR_OF_MEAN|71.37||0.035|TWO_SIDED||||||Mixed Models Analysis|degrees of freedom = 830|Right eye and Left Eye within each of the 2 treatment groups (Placebo and Valproic Acid) were combined to estimate the difference|||||0.035
72425624|NCT01233609|144362879|SUPERIORITY|||||||0.581|||||||Mixed Models Analysis|||||||0.581
72425625|NCT01233609|144362880|SUPERIORITY|||||||0.409|||||||Wilcoxon (Mann-Whitney)|||||||0.409
72425626|NCT01233609|144362881|SUPERIORITY|||||||0.229|||||||Wilcoxon (Mann-Whitney)|||||||0.229
72334971|NCT04392141|144192948|EQUIVALENCE|equivalence of mean of LDH between admission and discharge phases|Mean Difference (Final Values)|137.33||||0.006|TWO_SIDED|95.0|38.19|236.46|||t-test, 2 sided|Paired T-test||Statistical comparison of LDH between admission and discharge times in Colchicine and Herbal Phenolic Monoterpene Fractions treatment||236.46|38.19|0.006
72334972|NCT03622112|144192970|SUPERIORITY||Mean Difference (Final Values)|-0.036||||0.437|TWO_SIDED|95.0|-0.126|0.054|||Mixed Models Analysis|||||0.054|-0.126|0.437
72334973|NCT03622112|144192970|SUPERIORITY||Mean Difference (Final Values)|-0.054||||0.236|TWO_SIDED|95.0|-0.143|0.035|||Mixed Models Analysis|||||0.035|-0.143|0.236
72334974|NCT03622112|144192970|SUPERIORITY||Mean Difference (Final Values)|0.039||||0.389|TWO_SIDED|95.0|-0.05|0.128|||Mixed Models Analysis|||||0.128|-0.050|0.389
72334975|NCT03622112|144192970|SUPERIORITY||Mean Difference (Final Values)|0.076||||0.094|TWO_SIDED|95.0|-0.013|0.165|||Mixed Models Analysis|||||0.165|-0.013|0.094
72334976|NCT03622112|144192970|SUPERIORITY||Mean Difference (Final Values)|0.082||||0.06|TWO_SIDED|95.0|-0.003|0.167|||Mixed Models Analysis|||||0.167|-0.003|0.060
72334977|NCT03622112|144192970|SUPERIORITY||Mean Difference (Final Values)|0.111||||0.014|TWO_SIDED|95.0|0.023|0.199|||Mixed Models Analysis|||||0.199|0.023|0.014
72334978|NCT03622112|144192971|SUPERIORITY||Mean Difference (Final Values)|0.029||||0.463|TWO_SIDED|95.0|-0.048|0.105|||Mixed Models Analysis|||Week 2||0.105|-0.048|0.463
72334979|NCT03622112|144192971|SUPERIORITY||Mean Difference (Final Values)|0.022||||0.576|TWO_SIDED|95.0|-0.055|0.098|||Mixed Models Analysis|||Week 2||0.098|-0.055|0.576
72334980|NCT03622112|144192971|SUPERIORITY||Mean Difference (Final Values)|0.078||||0.047|TWO_SIDED|95.0|0.001|0.154|||Mixed Models Analysis|||Week 2||0.154|0.001|0.047
72334981|NCT03622112|144192971|SUPERIORITY||Mean Difference (Final Values)|0.102||||0.009|TWO_SIDED|95.0|0.025|0.179|||Mixed Models Analysis|||Week 2||0.179|0.025|0.009
72334982|NCT03622112|144192971|SUPERIORITY||Mean Difference (Final Values)|0.104||||0.006|TWO_SIDED|95.0|0.031|0.178|||Mixed Models Analysis|||Week 2||0.178|0.031|0.006
72334983|NCT03622112|144192971|SUPERIORITY||Mean Difference (Final Values)|0.118||||0.003|TWO_SIDED|95.0|0.041|0.194|||Mixed Models Analysis|||Week 2||0.194|0.041|0.003
72334984|NCT03622112|144192971|SUPERIORITY||Mean Difference (Final Values)|0.018||||0.685|TWO_SIDED|95.0|-0.068|0.103|||Mixed Models Analysis|||Week 4||0.103|-0.068|0.685
72334985|NCT03622112|144192971|SUPERIORITY||Mean Difference (Final Values)|0.059||||0.176|TWO_SIDED|95.0|-0.026|0.144|||Mixed Models Analysis|||Week 4||0.144|-0.026|0.176
72334986|NCT03622112|144192971|SUPERIORITY||Mean Difference (Final Values)|0.098||||0.024|TWO_SIDED|95.0|0.013|0.183|||Mixed Models Analysis|||Week 4||0.183|0.013|0.024
72334987|NCT03622112|144192971|SUPERIORITY||Mean Difference (Final Values)|0.106||||0.014|TWO_SIDED|95.0|0.021|0.191|||Mixed Models Analysis|||Week 4||0.191|0.021|0.014
72334988|NCT03622112|144192971|SUPERIORITY||Mean Difference (Final Values)|0.114||||0.006|TWO_SIDED|95.0|0.032|0.196|||Mixed Models Analysis|||Week 4||0.196|0.032|0.006
72334989|NCT03622112|144192971|SUPERIORITY||Mean Difference (Final Values)|0.165|||<|0.001|TWO_SIDED|95.0|0.081|0.249|||Mixed Models Analysis|||Week 4||0.249|0.081|< 0.001
72334990|NCT03622112|144192971|SUPERIORITY||Mean Difference (Final Values)|0.017||||0.707|TWO_SIDED|95.0|-0.072|0.106|||Mixed Models Analysis|||Week 8||0.106|-0.072|0.707
72334991|NCT03622112|144192971|SUPERIORITY||Mean Difference (Final Values)|0.005||||0.904|TWO_SIDED|95.0|-0.083|0.094|||Mixed Models Analysis|||Week 8||0.094|-0.083|0.904
72334992|NCT03622112|144192971|SUPERIORITY||Mean Difference (Final Values)|0.07||||0.121|TWO_SIDED|95.0|-0.018|0.157|||Mixed Models Analysis|||Week 8||0.157|-0.018|0.121
72334993|NCT03622112|144192971|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.026|TWO_SIDED|95.0|0.012|0.188|||Mixed Models Analysis|||Week 8||0.188|0.012|0.026
72334994|NCT03622112|144192971|SUPERIORITY||Mean Difference (Final Values)|0.139||||0.001|TWO_SIDED|95.0|0.055|0.224|||Mixed Models Analysis|||Week 8||0.224|0.055|0.001
72334995|NCT03622112|144192971|SUPERIORITY||Mean Difference (Final Values)|0.122||||0.006|TWO_SIDED|95.0|0.035|0.209|||Mixed Models Analysis|||Week 8||0.209|0.035|0.006
72334996|NCT03622112|144192971|SUPERIORITY||Mean Difference (Final Values)|0.007||||0.856|TWO_SIDED|95.0|-0.068|0.081|||Mixed Models Analysis|||Treatment period average||0.081|-0.068|0.856
72334997|NCT03622112|144192971|SUPERIORITY||Mean Difference (Final Values)|0.008||||0.832|TWO_SIDED|95.0|-0.066|0.082|||Mixed Models Analysis|||Treatment period average||0.082|-0.066|0.832
72334998|NCT03622112|144192971|SUPERIORITY||Mean Difference (Final Values)|0.071||||0.06|TWO_SIDED|95.0|-0.003|0.145|||Mixed Models Analysis|||Treatment period average||0.145|-0.003|0.060
72334999|NCT03622112|144192971|SUPERIORITY||Mean Difference (Final Values)|0.096||||0.011|TWO_SIDED|95.0|0.022|0.17|||Mixed Models Analysis|||Treatment period average||0.170|0.022|0.011
72335000|NCT03622112|144192971|SUPERIORITY||Mean Difference (Final Values)|0.11||||0.003|TWO_SIDED|95.0|0.039|0.181|||Mixed Models Analysis|||Treatment period average||0.181|0.039|0.003
72335001|NCT03622112|144192971|SUPERIORITY||Mean Difference (Final Values)|0.129|||<|0.001|TWO_SIDED|95.0|0.055|0.202|||Mixed Models Analysis|||Treatment period average||0.202|0.055|<0.001
72335002|NCT03622112|144192972|SUPERIORITY||Mean Difference (Final Values)|0.936||||0.322|TWO_SIDED|95.0|0.822|1.067|||Mixed Models Analysis|||Week 2||1.067|0.822|0.322
72425627|NCT01518946|144362928|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|521.0||||0.0131|TWO_SIDED|95.0|124.2|917.7|||ANOVA|||||917.7|124.2|0.0131
72335003|NCT03622112|144192972|SUPERIORITY||Mean Difference (Final Values)|0.876||||0.047|TWO_SIDED|95.0|0.768|0.999|||Mixed Models Analysis|||Week 2||0.999|0.768|0.047
72425628|NCT00384059|144362929|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|0.0||||||95.0|-3.8|3.9||||||For Meningococcal C the difference in percentage between the two groups (13vPnC - 7vPnC) at 1:8 titer was calculated||3.9|-3.8|
72335004|NCT03622112|144192972|SUPERIORITY||Mean Difference (Final Values)|0.842||||0.01|TWO_SIDED|95.0|0.739|0.959|||Mixed Models Analysis|||Week 2||0.959|0.739|0.010
72335005|NCT03622112|144192972|SUPERIORITY||Mean Difference (Final Values)|0.825||||0.004|TWO_SIDED|95.0|0.724|0.941|||Mixed Models Analysis|||Week 2||0.941|0.724|0.004
72335006|NCT03622112|144192972|SUPERIORITY||Mean Difference (Final Values)|0.687|||<|0.001|TWO_SIDED|95.0|0.606|0.779|||Mixed Models Analysis|||Week 2||0.779|0.606|<0.001
72335007|NCT03622112|144192972|SUPERIORITY||Mean Difference (Final Values)|0.63|||<|0.001|TWO_SIDED|95.0|0.553|0.719|||Mixed Models Analysis|||Week 2||0.719|0.553|<0.001
72425629|NCT00384059|144362929|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|-1.5||||||95.0|-7.1|3.7||||||For Haemophilus influenzae type b the difference in percentage between the two groups (13vPnC - 7vPnC) at 0.15 µg/mL threshold was calculated||3.7|-7.1|
72335008|NCT03622112|144192972|SUPERIORITY||Mean Difference (Final Values)|0.931||||0.329|TWO_SIDED|95.0|0.805|1.076|||Mixed Models Analysis|||Week 4||1.076|0.805|0.329
72335009|NCT03622112|144192972|SUPERIORITY||Mean Difference (Final Values)|0.911||||0.203|TWO_SIDED|95.0|0.789|1.052|||Mixed Models Analysis|||Week 4||1.052|0.789|0.203
72335010|NCT03622112|144192972|SUPERIORITY||Mean Difference (Final Values)|0.923||||0.273|TWO_SIDED|95.0|0.8|1.065|||Mixed Models Analysis|||Week 4||1.065|0.800|0.273
72335011|NCT03622112|144192972|SUPERIORITY||Mean Difference (Final Values)|0.846||||0.023|TWO_SIDED|95.0|0.734|0.977|||Mixed Models Analysis|||Week 4||0.977|0.734|0.023
72335012|NCT03622112|144192972|SUPERIORITY||Mean Difference (Final Values)|0.742|||<|0.001|TWO_SIDED|95.0|0.646|0.852|||Mixed Models Analysis|||Week 4||0.852|0.646|<0.001
72335013|NCT03622112|144192972|SUPERIORITY||Mean Difference (Final Values)|0.703|||<|0.001|TWO_SIDED|95.0|0.609|0.81|||Mixed Models Analysis|||Week 4||0.810|0.609|<0.001
72335014|NCT03622112|144192972|SUPERIORITY||Mean Difference (Final Values)|0.917||||0.283|TWO_SIDED|95.0|0.783|1.074|||Mixed Models Analysis|||Week 8||1.074|0.783|0.283
72335015|NCT03622112|144192972|SUPERIORITY||Mean Difference (Final Values)|0.933||||0.386|TWO_SIDED|95.0|0.797|1.092|||Mixed Models Analysis|||Week 8||1.092|0.797|0.386
72335016|NCT03622112|144192972|SUPERIORITY||Mean Difference (Final Values)|0.886||||0.126|TWO_SIDED|95.0|0.758|1.035|||Mixed Models Analysis|||Week 8||1.035|0.758|0.126
72335017|NCT03622112|144192972|SUPERIORITY||Mean Difference (Final Values)|0.855||||0.05|TWO_SIDED|95.0|0.731|1.0|||Mixed Models Analysis|||Week 8||1.000|0.731|0.050
72335018|NCT03622112|144192972|SUPERIORITY||Mean Difference (Final Values)|0.723|||<|0.001|TWO_SIDED|95.0|0.623|0.84|||Mixed Models Analysis|||Week 8||0.840|0.623|<0.001
72425630|NCT00384059|144362929|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|-4.1||||||95.0|-13.4|5.1||||||For Haemophilus influenzae type b the difference in percentage between the two groups (13vPnC - 7vPnC) at 1.0 µg/mL threshold was calculated||5.1|-13.4|
72335019|NCT03622112|144192972|SUPERIORITY||Mean Difference (Final Values)|0.642|||<|0.001|TWO_SIDED|95.0|0.55|0.749|||Mixed Models Analysis|||Week 8||0.749|0.550|<0.001
72335020|NCT03622112|144192972|SUPERIORITY||Mean Difference (Final Values)|0.927||||0.359|TWO_SIDED|95.0|0.789|1.09|||Mixed Models Analysis|||Week 12||1.090|0.789|0.359
72335021|NCT03622112|144192972|SUPERIORITY||Mean Difference (Final Values)|0.953||||0.556|TWO_SIDED|95.0|0.813|1.118|||Mixed Models Analysis|||Week 12||1.118|0.813|0.556
72335022|NCT03622112|144192972|SUPERIORITY||Mean Difference (Final Values)|0.869||||0.084|TWO_SIDED|95.0|0.742|1.019|||Mixed Models Analysis|||Week 12||1.019|0.742|0.084
72335023|NCT03622112|144192972|SUPERIORITY||Mean Difference (Final Values)|0.813||||0.011|TWO_SIDED|95.0|0.693|0.953|||Mixed Models Analysis|||Week 12||0.953|0.693|0.011
72335024|NCT03622112|144192972|SUPERIORITY||Mean Difference (Final Values)|0.65|||<|0.001|TWO_SIDED|95.0|0.559|0.757|||Mixed Models Analysis|||Week 12||0.757|0.559|<0.001
72335025|NCT03622112|144192972|SUPERIORITY||Mean Difference (Final Values)|0.623|||<|0.001|TWO_SIDED|95.0|0.533|0.729|||Mixed Models Analysis|||Week 12||0.729|0.533|<0.001
72335026|NCT03622112|144192972|SUPERIORITY||Mean Difference (Final Values)|0.928||||0.231|TWO_SIDED|95.0|0.821|1.049|||Mixed Models Analysis|||Treatment period average||1.049|0.821|0.231
72335027|NCT03622112|144192972|SUPERIORITY||Mean Difference (Final Values)|0.918||||0.17|TWO_SIDED|95.0|0.812|1.037|||Mixed Models Analysis|||Treatment period average||1.037|0.812|0.170
72335028|NCT03622112|144192972|SUPERIORITY||Mean Difference (Final Values)|0.879||||0.039|TWO_SIDED|95.0|0.778|0.994|||Mixed Models Analysis|||Treatment period average||0.994|0.778|0.039
72335029|NCT03622112|144192972|SUPERIORITY||Mean Difference (Final Values)|0.835||||0.004|TWO_SIDED|95.0|0.739|0.943|||Mixed Models Analysis|||Treatment period average||0.943|0.739|0.004
72335030|NCT03622112|144192972|SUPERIORITY||Mean Difference (Final Values)|0.7|||<|0.001|TWO_SIDED|95.0|0.622|0.787|||Mixed Models Analysis|||Treatment period average||0.787|0.622|<0.001
72335031|NCT03622112|144192972|SUPERIORITY||Mean Difference (Final Values)|0.649|||<|0.001|TWO_SIDED|95.0|0.575|0.732|||Mixed Models Analysis|||Treatment period average||0.732|0.575|<0.001
72335032|NCT03622112|144192973|SUPERIORITY||Mean Difference (Final Values)|-0.034||||0.519|TWO_SIDED|95.0|-0.139|0.07|||Mixed Models Analysis|||Week 12||0.070|-0.139|0.519
72335033|NCT03622112|144192973|SUPERIORITY||Mean Difference (Final Values)|-0.078||||0.141|TWO_SIDED|95.0|-0.181|0.026|||Mixed Models Analysis|||Week 12||0.026|-0.181|0.141
72335034|NCT03622112|144192973|SUPERIORITY||Mean Difference (Final Values)|0.015||||0.772|TWO_SIDED|95.0|-0.088|0.119|||Mixed Models Analysis|||Week 12||0.119|-0.088|0.772
72335035|NCT03622112|144192973|SUPERIORITY||Mean Difference (Final Values)|0.058||||0.27|TWO_SIDED|95.0|-0.045|0.162|||Mixed Models Analysis|||Week 12||0.162|-0.045|0.270
72335036|NCT03622112|144192973|SUPERIORITY||Mean Difference (Final Values)|0.027||||0.592|TWO_SIDED|95.0|-0.072|0.126|||Mixed Models Analysis|||Week 12||0.126|-0.072|0.592
72335037|NCT03622112|144192973|SUPERIORITY||Mean Difference (Final Values)|0.057||||0.275|TWO_SIDED|95.0|-0.045|0.158|||Mixed Models Analysis|||Week 12||0.158|-0.045|0.275
72335038|NCT03622112|144192973|SUPERIORITY||Mean Difference (Final Values)|-0.002||||0.963|TWO_SIDED|95.0|-0.087|0.083|||Mixed Models Analysis|||Treatment period average||0.083|-0.087|0.963
72335039|NCT03622112|144192973|SUPERIORITY||Mean Difference (Final Values)|-0.027||||0.533|TWO_SIDED|95.0|-0.112|0.058|||Mixed Models Analysis|||Treatment period average||0.058|-0.112|0.533
72335040|NCT03622112|144192973|SUPERIORITY||Mean Difference (Final Values)|0.041||||0.342|TWO_SIDED|95.0|-0.044|0.126|||Mixed Models Analysis|||Treatment period average||0.126|-0.044|0.342
72335041|NCT03622112|144192973|SUPERIORITY||Mean Difference (Final Values)|0.081||||0.061|TWO_SIDED|95.0|-0.004|0.165|||Mixed Models Analysis|||Treatment period average||0.165|-0.004|0.061
72335042|NCT03622112|144192973|SUPERIORITY||Mean Difference (Final Values)|0.045||||0.278|TWO_SIDED|95.0|-0.037|0.127|||Mixed Models Analysis|||Treatment period average||0.127|-0.037|0.278
72335043|NCT03622112|144192973|SUPERIORITY||Mean Difference (Final Values)|0.075||||0.079|TWO_SIDED|95.0|-0.009|0.159|||Mixed Models Analysis|||Treatment period average||0.159|-0.009|0.079
72335044|NCT03622112|144192974|SUPERIORITY||Mean Difference (Final Values)|-0.153||||0.088|TWO_SIDED|95.0|-0.328|0.023|||Mixed Models Analysis|||Week 12||0.023|-0.328|0.088
72425631|NCT00384059|144362929|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|0.0||||||95.0|-3.2|3.3||||||For Pertussis PT the difference in percentage between the two groups (13vPnC - 7vPnC) at 5 EU/mL threshold was calculated||3.3|-3.2|
72335045|NCT03622112|144192974|SUPERIORITY||Mean Difference (Final Values)|-0.257||||0.004|TWO_SIDED|95.0|-0.43|-0.084|||Mixed Models Analysis|||Week 12||-0.084|-0.430|0.004
72335046|NCT03622112|144192974|SUPERIORITY||Mean Difference (Final Values)|-0.221||||0.012|TWO_SIDED|95.0|-0.393|-0.049|||Mixed Models Analysis|||Week 12||-0.049|-0.393|0.012
72335047|NCT03622112|144192974|SUPERIORITY||Mean Difference (Final Values)|-0.193||||0.029|TWO_SIDED|95.0|-0.366|-0.02|||Mixed Models Analysis|||Week 12||-0.020|-0.366|0.029
72335048|NCT03622112|144192974|SUPERIORITY||Mean Difference (Final Values)|-0.269||||0.001|TWO_SIDED|95.0|-0.434|-0.104|||Mixed Models Analysis|||Week 12||-0.104|-0.434|0.001
72335049|NCT03622112|144192974|SUPERIORITY||Mean Difference (Final Values)|-0.223||||0.01|TWO_SIDED|95.0|-0.393|-0.054|||Mixed Models Analysis|||Week 12||-0.054|-0.393|0.010
72335050|NCT03622112|144192974|SUPERIORITY||Mean Difference (Final Values)|-0.125||||0.055|TWO_SIDED|95.0|-0.253|0.003|||Mixed Models Analysis|||Treatment period average||0.003|-0.253|0.055
72335051|NCT03622112|144192974|SUPERIORITY||Mean Difference (Final Values)|-0.141||||0.029|TWO_SIDED|95.0|-0.268|-0.014|||Mixed Models Analysis|||Treatment period average||-0.014|-0.268|0.029
72425632|NCT00384059|144362929|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|1.1||||||95.0|-4.5|7.1||||||For Pertussis PT the difference in percentage between the two groups (13vPnC - 7vPnC) at 17 EU/mL threshold was calculated||7.1|-4.5|
72335052|NCT03622112|144192974|SUPERIORITY||Mean Difference (Final Values)|-0.13||||0.044|TWO_SIDED|95.0|-0.257|-0.003|||Mixed Models Analysis|||Treatment period average||-0.003|-0.257|0.044
72335053|NCT03622112|144192974|SUPERIORITY||Mean Difference (Final Values)|-0.201||||0.002|TWO_SIDED|95.0|-0.328|-0.074|||Mixed Models Analysis|||Treatment period average||-0.074|-0.328|0.002
72335054|NCT03622112|144192974|SUPERIORITY||Mean Difference (Final Values)|-0.217|||<|0.001|TWO_SIDED|95.0|-0.339|-0.094|||Mixed Models Analysis|||Treatment period average||-0.094|-0.339|<0.001
72335055|NCT03622112|144192974|SUPERIORITY||Mean Difference (Final Values)|-0.179||||0.005|TWO_SIDED|95.0|-0.305|-0.053|||Mixed Models Analysis|||Treatment period average||-0.053|-0.305|0.005
72335056|NCT03622112|144192975|SUPERIORITY||Mean Difference (Final Values)|7.664||||0.097|TWO_SIDED|95.0|-1.403|16.73|||Mixed Models Analysis|||Treatment period average||16.730|-1.403|0.097
72335057|NCT03622112|144192975|SUPERIORITY||Mean Difference (Final Values)|5.981||||0.19|TWO_SIDED|95.0|-2.98|14.941|||Mixed Models Analysis|||Treatment period average||14.941|-2.980|0.190
72335058|NCT03622112|144192975|SUPERIORITY||Mean Difference (Final Values)|9.123||||0.045|TWO_SIDED|95.0|0.195|18.052|||Mixed Models Analysis|||Treatment period average||18.052|0.195|0.045
72335059|NCT03622112|144192975|SUPERIORITY||Mean Difference (Final Values)|15.444|||<|0.001|TWO_SIDED|95.0|6.443|24.445|||Mixed Models Analysis|||Treatment period average||24.445|6.443|<0.001
72335060|NCT03622112|144192975|SUPERIORITY||Mean Difference (Final Values)|16.599|||<|0.001|TWO_SIDED|95.0|8.031|25.167|||Mixed Models Analysis|||Treatment period average||25.167|8.031|<0.001
72335061|NCT03622112|144192975|SUPERIORITY||Mean Difference (Final Values)|10.491||||0.019|TWO_SIDED|95.0|1.726|19.256|||Mixed Models Analysis|||Treatment period average||19.256|1.726|0.019
72335062|NCT03622112|144192976|SUPERIORITY||Mean Difference (Final Values)|2.398||||0.597|TWO_SIDED|95.0|-6.494|11.29|||Mixed Models Analysis|||Treatment period average||11.290|-6.494|0.597
72335063|NCT03622112|144192976|SUPERIORITY||Mean Difference (Final Values)|2.162||||0.629|TWO_SIDED|95.0|-6.623|10.948|||Mixed Models Analysis|||Treatment period average||10.948|-6.623|0.629
72335064|NCT03622112|144192976|SUPERIORITY||Mean Difference (Final Values)|3.833||||0.389|TWO_SIDED|95.0|-4.907|12.573|||Mixed Models Analysis|||Treatment period average||12.573|-4.907|0.389
72335065|NCT03622112|144192976|SUPERIORITY||Mean Difference (Final Values)|10.258||||0.022|TWO_SIDED|95.0|1.456|19.059|||Mixed Models Analysis|||Treatment period average||19.059|1.456|0.022
72335066|NCT03622112|144192976|SUPERIORITY||Mean Difference (Final Values)|11.994||||0.005|TWO_SIDED|95.0|3.571|20.417|||Mixed Models Analysis|||Treatment period average||20.417|3.571|0.005
72335067|NCT03622112|144192976|SUPERIORITY||Mean Difference (Final Values)|6.129||||0.163|TWO_SIDED|95.0|-2.479|14.737|||Mixed Models Analysis|||Treatment period average||14.737|-2.479|0.163
72335068|NCT03622112|144192977|SUPERIORITY||Mean Difference (Final Values)|-0.243||||0.012|TWO_SIDED|95.0|-0.431|-0.054|||Mixed Models Analysis|||Treatment period average||-0.054|-0.431|0.012
72335069|NCT03622112|144192977|SUPERIORITY||Mean Difference (Final Values)|-0.155||||0.108|TWO_SIDED|95.0|-0.344|0.034|||Mixed Models Analysis|||Treatment period average||0.034|-0.344|0.108
72335070|NCT03622112|144192977|SUPERIORITY||Mean Difference (Final Values)|-0.099||||0.295|TWO_SIDED|95.0|-0.286|0.087|||Mixed Models Analysis|||Treatment period average||0.087|-0.286|0.295
72335071|NCT03622112|144192977|SUPERIORITY||Mean Difference (Final Values)|-0.308||||0.002|TWO_SIDED|95.0|-0.5|-0.116|||Mixed Models Analysis|||Treatment period average||-0.116|-0.500|0.002
72335072|NCT03622112|144192977|SUPERIORITY||Mean Difference (Final Values)|-0.308|||<|0.001|TWO_SIDED|95.0|-0.489|-0.126|||Mixed Models Analysis|||Treatment period average||-0.126|-0.489|<0.001
72335073|NCT03622112|144192977|SUPERIORITY||Mean Difference (Final Values)|-0.177||||0.062|TWO_SIDED|95.0|-0.362|0.009|||Mixed Models Analysis|||Treatment period average||0.009|-0.362|0.062
72335074|NCT03622112|144192978|SUPERIORITY||Mean Difference (Final Values)|-9.993|||<|0.001|TWO_SIDED|95.0|-15.795|-4.191|||Mixed Models Analysis|||Treatment period average||-4.191|-15.795|<0.001
72335075|NCT03622112|144192978|SUPERIORITY||Mean Difference (Final Values)|-7.972||||0.006|TWO_SIDED|95.0|-13.694|-2.251|||Mixed Models Analysis|||Treatment period average||-2.251|-13.694|0.006
72335076|NCT03622112|144192978|SUPERIORITY||Mean Difference (Final Values)|-4.361||||0.133|TWO_SIDED|95.0|-10.051|1.329|||Mixed Models Analysis|||Treatment period average||1.329|-10.051|0.133
72335077|NCT03622112|144192978|SUPERIORITY||Mean Difference (Final Values)|-7.797||||0.008|TWO_SIDED|95.0|-13.555|-2.04|||Mixed Models Analysis|||Treatment period average||-2.040|-13.555|0.008
72335078|NCT03622112|144192978|SUPERIORITY||Mean Difference (Final Values)|-8.729||||0.002|TWO_SIDED|95.0|-14.195|-3.264|||Mixed Models Analysis|||Treatment period average||-3.264|-14.195|0.002
72335079|NCT03622112|144192978|SUPERIORITY||Mean Difference (Final Values)|-11.622|||<|0.001|TWO_SIDED|95.0|-17.211|-6.034|||Mixed Models Analysis|||Treatment period average||-6.034|-17.211|<0.001
72335080|NCT03622112|144192979|SUPERIORITY||Mean Difference (Final Values)|-0.212|||<|0.001|TWO_SIDED|95.0|-0.329|-0.094|||Mixed Models Analysis|||Treatment period average||-0.094|-0.329|<0.001
72335081|NCT03622112|144192979|SUPERIORITY||Mean Difference (Final Values)|-0.11||||0.066|TWO_SIDED|95.0|-0.228|0.007|||Mixed Models Analysis|||Treatment period average||0.007|-0.228|0.066
72335082|NCT03622112|144192979|SUPERIORITY||Mean Difference (Final Values)|-0.139||||0.02|TWO_SIDED|95.0|-0.255|-0.022|||Mixed Models Analysis|||Treatment period average||-0.022|-0.255|0.020
72335083|NCT03622112|144192979|SUPERIORITY||Mean Difference (Final Values)|-0.23|||<|0.001|TWO_SIDED|95.0|-0.35|-0.11|||Mixed Models Analysis|||Treatment period average||-0.110|-0.350|<0.001
72335084|NCT03622112|144192979|SUPERIORITY||Mean Difference (Final Values)|-0.185||||0.001|TWO_SIDED|95.0|-0.298|-0.071|||Mixed Models Analysis|||Treatment period average||-0.071|-0.298|0.001
72335085|NCT03622112|144192979|SUPERIORITY||Mean Difference (Final Values)|-0.206|||<|0.001|TWO_SIDED|95.0|-0.321|-0.09|||Mixed Models Analysis|||Treatment period average||-0.090|-0.321|<0.001
72335086|NCT03622112|144192980|SUPERIORITY||Mean Difference (Final Values)|9.611||||0.026|TWO_SIDED|95.0|1.18|18.042|||Mixed Models Analysis|||Treatment period average||18.042|1.180|0.026
72335087|NCT03622112|144192980|SUPERIORITY||Mean Difference (Final Values)|5.503||||0.2|TWO_SIDED|95.0|-2.927|13.933|||Mixed Models Analysis|||Treatment period average||13.933|-2.927|0.200
72335088|NCT03622112|144192980|SUPERIORITY||Mean Difference (Final Values)|6.787||||0.11|TWO_SIDED|95.0|-1.546|15.119|||Mixed Models Analysis|||Treatment period average||15.119|-1.546|0.110
72335089|NCT03622112|144192980|SUPERIORITY||Mean Difference (Final Values)|10.066||||0.022|TWO_SIDED|95.0|1.461|18.672|||Mixed Models Analysis|||Treatment period average||18.672|1.461|0.022
72335090|NCT03622112|144192980|SUPERIORITY||Mean Difference (Final Values)|8.62||||0.038|TWO_SIDED|95.0|0.489|16.75|||Mixed Models Analysis|||Treatment period average||16.750|0.489|0.038
72335091|NCT03622112|144192980|SUPERIORITY||Mean Difference (Final Values)|7.178||||0.09|TWO_SIDED|95.0|-1.112|15.467|||Mixed Models Analysis|||Treatment period average||15.467|-1.112|0.090
72335092|NCT03622112|144192981|SUPERIORITY||Mean Difference (Final Values)|7.936||||0.123|TWO_SIDED|95.0|-2.16|18.031|||Mixed Models Analysis|||Treatment period average||18.031|-2.160|0.123
72335093|NCT03622112|144192981|SUPERIORITY||Mean Difference (Final Values)|0.977||||0.849|TWO_SIDED|95.0|-9.112|11.065|||Mixed Models Analysis|||Treatment period average||11.065|-9.112|0.849
72335094|NCT03622112|144192981|SUPERIORITY||Mean Difference (Final Values)|-1.242||||0.807|TWO_SIDED|95.0|-11.233|8.748|||Mixed Models Analysis|||Treatment period average||8.748|-11.233|0.807
72335095|NCT03622112|144192981|SUPERIORITY||Mean Difference (Final Values)|11.789||||0.025|TWO_SIDED|95.0|1.488|22.09|||Mixed Models Analysis|||Treatment period average||22.090|1.488|0.025
72335096|NCT03622112|144192981|SUPERIORITY||Mean Difference (Final Values)|7.574||||0.127|TWO_SIDED|95.0|-2.16|17.307|||Mixed Models Analysis|||Treatment period average||17.307|-2.160|0.127
72335097|NCT03622112|144192981|SUPERIORITY||Mean Difference (Final Values)|5.058||||0.318|TWO_SIDED|95.0|-4.874|14.99|||Mixed Models Analysis|||Treatment period average||14.990|-4.874|0.318
72335098|NCT03622112|144192982|SUPERIORITY||Mean Difference (Final Values)|10.45||||0.015|TWO_SIDED|95.0|2.046|18.855|||Mixed Models Analysis|||Treatment period average||18.855|2.046|0.015
72335099|NCT03622112|144192982|SUPERIORITY||Mean Difference (Final Values)|7.192||||0.093|TWO_SIDED|95.0|-1.208|15.592|||Mixed Models Analysis|||Treatment period average||15.592|-1.208|0.093
72335100|NCT03622112|144192982|SUPERIORITY||Mean Difference (Final Values)|8.606||||0.042|TWO_SIDED|95.0|0.298|16.913|||Mixed Models Analysis|||Treatment period average||16.913|0.298|0.042
72335101|NCT03622112|144192982|SUPERIORITY||Mean Difference (Final Values)|11.344||||0.01|TWO_SIDED|95.0|2.773|19.914|||Mixed Models Analysis|||Treatment period average||19.914|2.773|0.010
72335102|NCT03622112|144192982|SUPERIORITY||Mean Difference (Final Values)|10.122||||0.014|TWO_SIDED|95.0|2.021|18.222|||Mixed Models Analysis|||Treatment period average||18.222|2.021|0.014
72335103|NCT03622112|144192982|SUPERIORITY||Mean Difference (Final Values)|10.689||||0.011|TWO_SIDED|95.0|2.424|18.953|||Mixed Models Analysis|||Treatment period average||18.953|2.424|0.011
72335104|NCT03622112|144192993|SUPERIORITY||geometric LSMean ratio|1.01||||0.909|TWO_SIDED|95.0|0.851|1.199|||Mixed Models Analysis|||||1.199|0.851|0.909
72335105|NCT03622112|144192993|SUPERIORITY||geometric LSMean ratio|1.118||||0.218|TWO_SIDED|95.0|0.935|1.336|||Mixed Models Analysis|||||1.336|0.935|0.218
72335106|NCT03622112|144192993|SUPERIORITY||geometric LSMean ratio|1.129||||0.181|TWO_SIDED|95.0|0.944|1.349|||Mixed Models Analysis|||||1.349|0.944|0.181
72335107|NCT03622112|144192993|SUPERIORITY||geometric LSMean ratio|0.984||||0.859|TWO_SIDED|95.0|0.825|1.174|||Mixed Models Analysis|||||1.174|0.825|0.859
72335108|NCT03622112|144192993|SUPERIORITY||geometric LSMean ratio|0.916||||0.285|TWO_SIDED|95.0|0.78|1.077|||Mixed Models Analysis|||||1.077|0.780|0.285
72425633|NCT00384059|144362929|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|0.0||||||95.0|-3.2|3.2||||||For Pertussis FHA the difference in percentage between the two groups (13vPnC - 7vPnC) at 5 EU/mL threshold was calculated||3.2|-3.2|
72335109|NCT03622112|144192993|SUPERIORITY||geometric LSMean ratio|0.991||||0.923|TWO_SIDED|95.0|0.831|1.182|||Mixed Models Analysis|||||1.182|0.831|0.923
72335110|NCT00521599|144193001|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|assume n=240 per group and standard deviation (STD) = 45 L/min for AM Peak Flow Rate at Week 8. If the two actives are the same, 95% CI of their mean difference has 90% probability to be completely within +/- 15 L/min.|Mean Difference (Net)|-1.62|STANDARD_DEVIATION|37.0||0.654|TWO_SIDED|95.0|-8.74|5.49|||ANOVA|||Week 8 End scores||5.49|-8.74|0.654
72335111|NCT00521599|144193001|SUPERIORITY_OR_OTHER_LEGACY|||||||0.003||95.0|||||ANOVA|||Week 8 End scores||||0.003
72335112|NCT00521599|144193001|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001||95.0|||||ANOVA|||Week 8 End scores||||0.001
72335113|NCT03359785|144193073|SUPERIORITY||LS Mean Difference|0.278|STANDARD_ERROR_OF_MEAN|0.376||0.2401|ONE_SIDED|90.0|-0.246||||ANOVA||||||-0.246|0.2401
72335114|NCT03359785|144193073|SUPERIORITY||LS Mean Difference|-0.766|STANDARD_ERROR_OF_MEAN|0.547||0.9053|ONE_SIDED|90.0|-1.513||||ANOVA||||||-1.513|0.9053
72335115|NCT03650803|144193096|OTHER|Significance (alpha) set to 0.05||||||0.046|||||||t-test, 1 sided|||MRF T1 Changes||||0.046
72335116|NCT03650803|144193096|OTHER|Significance (alpha) set to 0.05||||||0.064|||||||t-test, 2 sided|||MRF T2 Changes||||0.064
72335117|NCT03650803|144193097|OTHER|Significance (alpha) set to 0.05||||||0.82|||||||t-test, 2 sided|||MRF T1 relaxation time||||0.820
72335118|NCT03650803|144193097|OTHER|Significance (alpha) set to 0.05||||||0.605|||||||t-test, 2 sided|||MRF T2 relaxation time||||0.605
72335119|NCT03655301|144193110|OTHER||Least squares mean|0.9405|||||TWO_SIDED|90.0|0.8093|1.0931||||||Day 8 (with copanlisib) to Day 1 (without copanlisib) ratio of Cmax||1.0931|0.8093|
72425634|NCT00384059|144362929|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|0.0||||||95.0|-3.2|3.2||||||For Pertussis FHA the difference in percentage between the two groups (13vPnC - 7vPnC) at 7.82 EU/mL threshold was calculated||3.2|-3.2|
72335120|NCT03655301|144193111|OTHER||Least squares mean|1.1205|||||TWO_SIDED|90.0|1.0|1.2555||||||Day 8 (with copanlisib) to Day 1 (without copanlisib) ratio of AUC(0-24)||1.2555|1.0000|
72335121|NCT03655301|144193112|OTHER||Least squares mean|1.1147|||||TWO_SIDED|90.0|0.9772|1.2714||||||Day 8 (with copanlisib) to Day 1 (without copanlisib) ratio of AUC||1.2714|0.9772|
72335122|NCT02950155|144193138|SUPERIORITY||probability ratio|2.48||||0.007|TWO_SIDED|95.0|1.2|5.11|||Fisher Exact|||The primary end-point was analyzed as an intention-to-treat analysis, with Fisher's exact test of the difference in proportion, with α=0·05 to indicate statistically significant difference||5.11|1.20|0.007
72335123|NCT02950155|144193139|SUPERIORITY||Mean Difference (Final Values)|-1.1||||0.79|TWO_SIDED|95.0|-4.4|2.1|||Wilcoxon (Mann-Whitney)|||Subjects receiving rescue treatment before evaluation being censored (per-protocol analysis)||2.1|-4.4|0.79
72335124|NCT02950155|144193140|SUPERIORITY||Mean Difference (Final Values)|-1.2||||0.34|TWO_SIDED|95.0|-3.3|0.8|||Wilcoxon (Mann-Whitney)|||Subjects receiving rescue treatment before evaluation being censored (per-protocol analysis)||0.8|-3.3|0.34
72335125|NCT02950155|144193141|SUPERIORITY||Mean Difference (Final Values)|-2.2||||0.47|TWO_SIDED|95.0|-8.2|3.8|||Wilcoxon (Mann-Whitney)|||Subjects receiving rescue treatment before evaluation being censored (per-protocol analysis)||3.8|-8.2|0.47
72425635|NCT00384059|144362929|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|-1.5||||||95.0|-7.9|4.8||||||For Pertussis FHA the difference in percentage between the two groups (13vPnC - 7vPnC) at 20 EU/mL threshold was calculated||4.8|-7.9|
72335126|NCT02950155|144193142|SUPERIORITY||probability ratio|1.89||||0.036|TWO_SIDED|95.0|1.04|3.44|||Fisher Exact|||||3.44|1.04|0.036
72335127|NCT02979093|144193149|SUPERIORITY||Mean Difference (Final Values)|0.1697|STANDARD_ERROR_OF_MEAN|0.1025||0.106|TWO_SIDED|||||Unadjusted|Mixed Models Analysis|||This analysis is for Striatum: Happy Own vs. Happy Unknown||||0.106
72335128|NCT02979093|144193149|SUPERIORITY||Mean Difference (Final Values)|0.20458|STANDARD_ERROR_OF_MEAN|0.1101||0.0709|TWO_SIDED|||||Unadjusted|Mixed Models Analysis|||This analysis is for the Amygdala: Happy Own vs. Happy Unknown infant faces.||||0.0709
72335129|NCT02979093|144193149|SUPERIORITY||Mean Difference (Final Values)|-0.14559|STANDARD_ERROR_OF_MEAN|0.08546||0.0964|TWO_SIDED|||||Unadjusted|Mixed Models Analysis|||This analysis is for Striatum: Sad Own vs. Sad Unknown infant faces.||||0.0964
72335130|NCT02979093|144193149|SUPERIORITY||Mean Difference (Final Values)|-0.15755|STANDARD_ERROR_OF_MEAN|0.07914||0.0538|TWO_SIDED|||||Unadjusted|Mixed Models Analysis|||This analysis is for Amygdala: Sad Own vs. Sad Unknown infant faces.||||0.0538
72335131|NCT02979093|144193150|SUPERIORITY||Mean Difference (Final Values)|0.09778|STANDARD_ERROR_OF_MEAN|0.09687||0.319|TWO_SIDED|||||unadjusted|Mixed Models Analysis|||"This is a mixed effects model with group (Addiction vs. Control) and condition (Oxytocin \[OT\] vs Placebo).~Both variables were included in the model. The interaction effect was tested but not included in the model. This result focuses on OT vs. placebo for Ventromedial prefrontal cortex (vmPFC) for happy own vs. happy unknown infant faces."||||0.319
72335132|NCT02979093|144193150|SUPERIORITY||Mean Difference (Final Values)|-0.15289|STANDARD_ERROR_OF_MEAN|0.10968||0.171|TWO_SIDED|||||unadjusted|Mixed Models Analysis|||"This is a mixed effects model with group (addiction vs. control) and condition (OT vs Placebo).~Both variables were included in the model. The interaction effect was tested but not included in the model. This result focuses on addiction vs. control for vmPFC for Happy Own vs. Happy Unknown infant faces."||||0.171
72425636|NCT00384059|144362929|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|0.0||||||95.0|-3.2|3.2||||||For Pertussis PRN the difference in percentage between the two groups (13vPnC - 7vPnC) at 5 EU/mL threshold was calculated||3.2|-3.2|
72335133|NCT02979093|144193150|SUPERIORITY||Mean Difference (Final Values)|-0.20839|STANDARD_ERROR_OF_MEAN|0.08405||0.0179|TWO_SIDED|||||Unadjusted|Mixed Models Analysis|||"This is a mixed effects model with group (addiction vs. control) and condition (OT vs Placebo).~Both variables were included in the model. The interaction effect was tested but not included in the model. This result focuses on OT vs placebo for Dorsolateral Prefrontal Cortex (dlPFC) for Sad Own vs. Sad Unknown infant faces."||||0.0179
72335134|NCT02979093|144193150|SUPERIORITY||Mean Difference (Final Values)|0.04315|STANDARD_ERROR_OF_MEAN|0.11827||0.7171|TWO_SIDED|||||unadjusted|Mixed Models Analysis|||"This is a mixed effects model with group (addiction vs. control) and condition (OT vs Placebo).~Both variables were included in the model. The interaction effect was tested but not included in the model. This result focuses on addiction vs. control for dlPFC for Sad Own vs. Sad Unknown infant faces."||||0.7171
72335135|NCT01096368|144193169|SUPERIORITY||Hazard Ratio (HR)|0.866||||0.229|TWO_SIDED|90.46|0.627|1.197||P-value is one-sided. After adjusting for interim analyses, the a priori threshold for significance for the final analysis is one-sided alpha=0.031.|Log Rank||Hazard ratio is based on hazard of events for Arm II over hazard of events for Arm III. Confidence interval is stage-wise adjusted for multiple interim analyses.|The study was designed to test the superiority of RT+maintenance vs. RT alone as measured by EFS using the hazard ratio via a 1-sided log-rank test. The planned sample size was 160 subjects per arm. 85 EFS events were needed, which were expected after 8 years of accrual and 2 years of follow-up. At 5% type 1 error, the study had 93% power to detect an increase in 2-year EFS from 75% (RT alone) to 87% (RT+maintenance). The design also incorporated interim analyses for futility and efficacy.||1.197|0.627|0.229
72425637|NCT00384059|144362929|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|-3.1||||||95.0|-10.0|3.4||||||For Pertussis PRN the difference in percentage between the two groups (13vPnC - 7vPnC) at 15 EU/mL threshold was calculated||3.4|-10.0|
72425638|NCT00384059|144362929|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|2.7||||||95.0|-0.5|7.6||||||For Pertussis FIM the difference in percentage between the two groups (13vPnC - 7vPnC) at 2.2 EU/mL threshold was calculated||7.6|-0.5|
72425639|NCT00384059|144362929|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|1.0||||||95.0|-4.1|6.5||||||For Pertussis FIM the difference in percentage between the two groups (13vPnC - 7vPnC) at 5 EU/mL threshold was calculated||6.5|-4.1|
72425640|NCT00384059|144362930|SUPERIORITY_OR_OTHER||Difference|-5.3||||||95.0|-19.7|8.8||||||For Meningococcal C the difference in percentage between the two groups (13vPnC - 7vPnC) at 1:8 titer was calculated||8.8|-19.7|
72425641|NCT00384059|144362930|SUPERIORITY_OR_OTHER||Difference|-0.1||||||95.0|-8.0|8.1||||||For Meningococcal C the difference in percentage between the two groups (13vPnC - 7vPnC) at 1:8 titer was calculated||8.1|-8.0|
72425642|NCT00384059|144362931|SUPERIORITY_OR_OTHER||Difference|0.0||||||95.0|-3.5|3.8||||||For Haemophilus influenzae type b the difference in percentage between the two groups (13vPnC - 7vPnC) at 0.15 µg/mL threshold was calculated||3.8|-3.5|
72425643|NCT00384059|144362931|SUPERIORITY_OR_OTHER||Difference|-1.0||||||95.0|-5.3|2.8||||||For Haemophilus influenzae type b the difference in percentage between the two groups (13vPnC - 7vPnC) at 1.0 µg/mL threshold was calculated||2.8|-5.3|
72425644|NCT00384059|144362932|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for the concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|0.89||||||95.0|0.68|1.16||||||For Meningococcal C the GMC ratio (13vPnC/7vPnC) was calculated||1.16|0.68|
72425645|NCT00384059|144362933|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for the concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|0.77||||||95.0|0.54|1.08||||||For Haemophilus influenzae type b the GMC ratio (13vPnC/7vPnC) was calculated||1.08|0.54|
72425646|NCT00384059|144362934|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for the concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|0.98||||||95.0|0.82|1.16||||||For Pertussis FHA the GMC ratio (13vPnC/7vPnC) was calculated||1.16|0.82|
72425647|NCT00384059|144362934|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for the concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|0.99||||||95.0|0.83|1.17||||||For Pertussis PT the GMC ratio (13vPnC/7vPnC) was calculated||1.17|0.83|
72425648|NCT00384059|144362934|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for the concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|1.0||||||95.0|0.8|1.26||||||For Pertussis PRN the GMC ratio (13vPnC/7vPnC) was calculated||1.26|0.80|
72425649|NCT00384059|144362934|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for the concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|1.0||||||95.0|0.81|1.23||||||For Pertussis FIM the GMC ratio (13vPnC/7vPnC) was calculated||1.23|0.81|
72425650|NCT00384059|144362935|SUPERIORITY_OR_OTHER||Ratio|1.13||||||95.0|0.83|1.53||||||For Haemophilus influenzae type b the GMC ratio (13vPnC/7vPnC) was calculated||1.53|0.83|
72425651|NCT00384059|144362940|SUPERIORITY_OR_OTHER||Ration|0.85||||||95.0|0.48|1.49||||||For Meningococcal C the GMC ratio (13vPnC/7vPnC) was calculated||1.49|0.48|
72335136|NCT01096368|144193170|SUPERIORITY||Hazard Ratio (HR)|0.757||||0.172|TWO_SIDED|90.46|0.463|1.238||P-value is one-sided. After adjusting for interim analyses, the a priori threshold for significance for the final analysis is one-sided alpha=0.031.|Log Rank||Hazard ratio is based on hazard of death for Arm II over hazard of death for Arm III. Confidence interval is stage-wise adjusted for multiple interim analyses.|It was planned to test the superiority of RT+maintenance vs. RT alone as measured by OS using the hazard ratio via a 1-sided log-rank test using the planned sample size of 160 subjects per arm which was optimized for the EFS outcome. A one-sided significance threshold of 5% was planned for this comparison as well.||1.238|0.463|0.172
72335137|NCT01096368|144193171|SUPERIORITY||Hazard Ratio (HR)|0.701||||0.096|TWO_SIDED|95.0|0.461|1.068||P-value is two-sided and not adjusted for multiple comparisons for this exploratory subgroup comparison.|Log Rank||Hazard ratio is based on hazard of events for Arm II over hazard of events for Arm III.|In stratum 1, it was also planned to test the superiority of RT+maintenance vs. RT alone as measured by EFS using the hazard ratio via a 2-sided log-rank test. A two-sided significance threshold of 5% was planned for this comparison.||1.068|0.461|0.096
72335138|NCT01096368|144193172|SUPERIORITY||Hazard Ratio (HR)|2.684||||0.041|TWO_SIDED|95.0|1.004|7.175||P-value is two-sided and not adjusted for multiple comparisons for this exploratory subgroup comparison.|Log Rank||Hazard ratio is based on hazard of events for Arm II over hazard of events for Arm III.|In stratum 2, it was also planned to test the superiority of RT+maintenance vs. RT alone as measured by EFS using the hazard ratio via a 2-sided log-rank test. A two-sided significance threshold of 5% was planned for this comparison.||7.175|1.004|0.041
72335139|NCT01096368|144193173|SUPERIORITY||Hazard Ratio (HR)|0.547||||0.067|TWO_SIDED|95.0|0.284|1.053||P-value is two-sided and not adjusted for multiple comparisons for this exploratory subgroup comparison.|Log Rank||Hazard ratio is based on hazard of death for Arm II over death of events for Arm III.|In stratum 1, it was also planned to test the superiority of RT+maintenance vs. RT alone as measured by OS using the hazard ratio via a 2-sided log-rank test. A two-sided significance threshold of 5% was planned for this comparison.||1.053|0.284|0.067
72335140|NCT01096368|144193174|SUPERIORITY||Hazard Ratio (HR)|3.601||||0.094|TWO_SIDED|95.0|0.724|17.902||P-value is two-sided and not adjusted for multiple comparisons for this exploratory subgroup comparison.|Log Rank||Hazard ratio is based on hazard of death for Arm II over hazard of death for Arm III.|In stratum 2, it was also planned to test the superiority of RT+maintenance vs. RT alone as measured by OS using the hazard ratio via a 2-sided log-rank test. A two-sided significance threshold of 5% was planned for this comparison.||17.902|0.724|0.094
72335141|NCT03070223|144193179|SUPERIORITY||Mean Difference (Net)|-0.1||||0.31|TWO_SIDED|95.0|-0.3|0.1|||Mixed Models Analysis|P-value is from the time and treatment group interaction.|Treatment effect was estimated as the difference in annualized rate of change (slope) with randomized pitavastatin compared to placebo from linear mixed effects models (0 reflects no difference between treatment groups).|||0.10|-0.30|0.31
72335142|NCT03070223|144193181|SUPERIORITY||Mean Difference (Final Values)|0.58||||0.62|TWO_SIDED|95.0|-1.72|2.88|||Regression, Linear||Treatment group difference was estimated using baseline-adjusted linear regression model.|Comparison of Month 24 values||2.88|-1.72|0.62
72335143|NCT03070223|144193182|SUPERIORITY||Mean Difference (Net)|-0.001||||0.61|TWO_SIDED|95.0|-0.007|0.004|||Mixed Models Analysis|P-value is from the time and treatment group interaction.|Treatment effect was estimated as the difference in annualized rate of change (slope) with randomized pitavastatin compared to placebo from linear mixed effects models (0 reflects no difference between treatment groups).|||0.004|-0.007|0.61
72335144|NCT03070223|144193183|SUPERIORITY||Mean Difference (Net)|-0.028||||0.8|TWO_SIDED|95.0|-0.25|0.19|||Mixed Models Analysis|P-value is from the time and treatment group interaction.|Treatment effect was estimated as the difference in annualized rate of change (slope) with randomized pitavastatin compared to placebo from linear mixed effects models (0 reflects no difference between treatment groups).|||0.19|-0.25|0.80
72335145|NCT03070223|144193184|SUPERIORITY||Risk Ratio (RR)|1.02||||0.33|TWO_SIDED|95.0|0.98|1.06|||Log-binomial regression using GEE|P-value is from the time and treatment group interaction.|Treatment effect is shown as relative annualized risk of impairment in the pitavastatin group compared to placebo (1 reflects no difference between treatment groups).|||1.06|0.98|0.33
72335146|NCT03070223|144193185|SUPERIORITY||Mean Difference (Net)|-0.005||||0.18|TWO_SIDED|95.0|-0.013|0.002|||Mixed Models Analysis|P-value is from the time and treatment group interaction.|Treatment effect was estimated as the difference in annualized rate of change (slope) with randomized pitavastatin compared to placebo from linear mixed effects models (0 reflects no difference between treatment groups).|||0.002|-0.013|0.18
72335147|NCT03070223|144193186|SUPERIORITY||Risk Ratio (RR)|1.06||||0.47|TWO_SIDED|95.0|0.91|1.24|||Log-binomial regression using GEE|P-value is from the time (before vs. after study treatment initiation) and treatment group interaction.|Treatment effect is shown as relative average risk of impairment over follow-up time in the pitavastatin group compared to placebo (1 reflects no difference between treatment groups).|||1.24|0.91|0.47
72425652|NCT03029247|144362967|SUPERIORITY||LS Mean Difference|-0.17||||0.9694|TWO_SIDED|95.0|-8.8|8.47||p-value for the difference between treatment groups were presented from ANCOVA model for the superiority assessment.|ANCOVA||LS Mean treatment difference (daprodustat minus recombinant human erythropoietin) and its corresponding 95% confidence interval (CI) has been presented.|||8.47|-8.80|0.9694
72425653|NCT03029247|144362968|SUPERIORITY||LS Mean Difference|-1.32||||0.7745|TWO_SIDED|95.0|-10.46|7.83||p-value for the difference between treatment groups was presented from ANCOVA model for the superiority assessment.|ANCOVA||LS Mean treatment difference (daprodustat minus recombinant human erythropoietin) of SBP and its corresponding 95% CI has been presented.|||7.83|-10.46|0.7745
72425654|NCT03029247|144362968|SUPERIORITY||LS Mean Difference|-1.95||||0.291|TWO_SIDED|95.0|-5.62|1.71||p-value for the difference between treatment groups was presented from ANCOVA model for the superiority assessment.|ANCOVA||LS Mean treatment difference (daprodustat minus recombinant human erythropoietin) of DBP and its corresponding 95% CI has been presented.|||1.71|-5.62|0.2910
72425655|NCT03029247|144362968|SUPERIORITY||LS Mean Difference|-2.4||||0.4611|TWO_SIDED|95.0|-8.88|4.07||p-value for the difference between treatment groups was presented from ANCOVA model for the superiority assessment.|ANCOVA||LS Mean treatment difference (daprodustat minus recombinant human erythropoietin) of MAP and its corresponding 95% CI has been presented.|||4.07|-8.88|0.4611
72425656|NCT03029247|144362969|SUPERIORITY||LS Mean Difference|-2.95||||0.1648|TWO_SIDED|95.0|-7.14|1.24||p-value for the difference between treatment groups was presented from ANCOVA model for the superiority assessment.|ANCOVA||LS Mean treatment difference (daprodustat minus recombinant human erythropoietin) and its corresponding 95% CI has been presented.|||1.24|-7.14|0.1648
72425657|NCT03029247|144362970|SUPERIORITY||LS Mean Difference|-13.42||||0.9142|TWO_SIDED|95.0|-261.75|234.92||p-value for the difference between treatment groups was presented from ANCOVA model for the superiority assessment.|ANCOVA||LS Mean treatment difference (daprodustat minus recombinant human erythropoietin) for AUEC of SBP and its corresponding 95% CI has been presented.|||234.92|-261.75|0.9142
72425658|NCT03029247|144362970|SUPERIORITY||LS Mean Difference|-71.7||||0.2266|TWO_SIDED|95.0|-189.21|45.8||p-value for the difference between treatment groups was presented from ANCOVA model for the superiority assessment.|ANCOVA||LS Mean treatment difference (daprodustat minus recombinant human erythropoietin) for AUEC of DBP and its corresponding 95% CI has been presented.|||45.80|-189.21|0.2266
72425659|NCT03029247|144362970|SUPERIORITY||LS Mean Difference|-54.24||||0.5246|TWO_SIDED|95.0|-223.99|115.51||p-value for the difference between treatment groups was presented from ANCOVA model for the superiority assessment.|ANCOVA||LS Mean treatment difference (daprodustat minus recombinant human erythropoietin) for AUEC of MAP and its corresponding 95% CI has been presented.|||115.51|-223.99|0.5246
72425660|NCT03029247|144362971|SUPERIORITY||LS Mean Difference|-74.4||||0.1563|TWO_SIDED|95.0|-178.15|29.34||p-value for the difference between treatment groups was presented from ANCOVA model for the superiority assessment.|ANCOVA||LS Mean treatment difference (daprodustat minus recombinant human erythropoietin) for AUEC of HR and its corresponding 95% CI has been presented.|||29.34|-178.15|0.1563
72425661|NCT03029247|144362972|SUPERIORITY||LS Mean Difference|-2.06||||0.3247|TWO_SIDED|95.0|-6.23|2.1||p-value for the difference between treatment groups was presented from ANCOVA model for the superiority assessment.|ANCOVA||LS Mean treatment difference (daprodustat minus recombinant human erythropoietin) of DBP and its corresponding 95% CI has been presented.|||2.10|-6.23|0.3247
72425662|NCT03029247|144362972|SUPERIORITY||LS Mean Difference|-2.51||||0.4235|TWO_SIDED|95.0|-8.76|3.74||p-value for the difference between treatment groups was presented from ANCOVA model for the superiority assessment.|ANCOVA||LS Mean treatment difference (daprodustat minus recombinant human erythropoietin) of MAP and its corresponding 95% CI has been presented.|||3.74|-8.76|0.4235
72425663|NCT03029247|144362973|SUPERIORITY||LS Mean Difference|-0.13||||0.9353|TWO_SIDED|95.0|-3.41|3.14||p-value for the difference between treatment groups was presented from ANCOVA model for the superiority assessment.|ANCOVA||LS Mean treatment difference (daprodustat minus recombinant human erythropoietin) and its corresponding 95% CI has been presented.|||3.14|-3.41|0.9353
72425664|NCT03029247|144362974|SUPERIORITY||LS Mean Difference|-144.97||||0.2573|TWO_SIDED|95.0|-399.71|109.76||p-value for the difference between treatment groups was presented from ANCOVA model for the superiority assessment.|ANCOVA||LS Mean treatment difference (daprodustat minus recombinant human erythropoietin) for AUEC of SBP and its corresponding 95% CI has been presented.|||109.76|-399.71|0.2573
72425665|NCT03029247|144362974|SUPERIORITY||LS Mean Difference|-117.49||||0.045|TWO_SIDED|95.0|-232.26|-2.72||p-value for the difference between treatment groups was presented from ANCOVA model for the superiority assessment.|ANCOVA||LS Mean treatment difference (daprodustat minus recombinant human erythropoietin) for AUEC of DBP and its corresponding 95% CI has been presented.|||-2.72|-232.26|0.0450
72335148|NCT03070223|144193191|SUPERIORITY||Mean Difference (Final Values)|-0.6||||0.55|TWO_SIDED|95.0|-2.7|1.4|||Regression, Linear||Treatment group difference at Month 24 (pitavastatin minus placebo) was estimated using baseline-adjusted linear regression model (0 reflects no difference between treatment groups).|Comparison of Month 24 values||1.4|-2.7|0.55
72335149|NCT03070223|144193192|SUPERIORITY||Mean Difference (Final Values)|-0.5||||0.67|TWO_SIDED|95.0|-2.8|1.8|||Regression, Linear||Treatment group difference at Month 24 (pitavastatin minus placebo) was estimated using baseline-adjusted linear regression model (0 reflects no difference between treatment groups).|Comparison of Month 24 values||1.8|-2.8|0.67
72335150|NCT03070223|144193193|SUPERIORITY||Mean Difference (Final Values)|0.01||||0.98|TWO_SIDED|95.0|-0.5|0.52|||Regression, Linear||Treatment group difference (pitavastatin minus placebo) at Month 24 was estimated using baseline-adjusted linear regression model (0 reflects no difference between treatment groups).|Comparison of Month 24 values||0.52|-0.50|0.98
72335151|NCT03070223|144193194|SUPERIORITY||Mean Difference (Final Values)|-0.3||||0.31|TWO_SIDED|95.0|-0.8|0.3|||Regression, Linear||Treatment group difference at Month 24 (pitavastatin minus placebo) was estimated using baseline-adjusted linear regression model (0 reflects no difference between treatment groups).|Comparison of Month 24 values||0.3|-0.8|0.31
72335152|NCT03070223|144193195|SUPERIORITY||Mean Difference (Final Values)|0.4||||0.21|TWO_SIDED|95.0|-0.2|0.9|||Regression, Linear||Treatment group difference at Month 24 (pitavastatin minus placebo) was estimated using baseline-adjusted linear regression model (0 reflects no difference between treatment groups).|Comparison of Month 24 values||0.9|-0.2|0.21
72425666|NCT03029247|144362974|SUPERIORITY||LS Mean Difference|-131.94||||0.1341|TWO_SIDED|95.0|-306.24|42.36||p-value for the difference between treatment groups was presented from ANCOVA model for the superiority assessment.|ANCOVA||LS Mean treatment difference (daprodustat minus recombinant human erythropoietin) for AUEC of MAP and its corresponding 95% CI has been presented.|||42.36|-306.24|0.1341
72335153|NCT02308163|144193197|SUPERIORITY||Odds Ratio (OR)|3.13|||<|0.001|TWO_SIDED|95.0|1.76|5.58||Closed testing procedure was used for multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Wald's chi-squared test||Based on logistic regression model: ACR20-CRP response (responder, non-responder) = Treatment + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||5.58|1.76|<0.001
72335154|NCT02308163|144193197|SUPERIORITY||Odds Ratio (OR)|6.59|||<|0.001|TWO_SIDED|95.0|3.56|12.2||Closed testing procedure was used for multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Wald's chi-squared test||Based on logistic regression model: ACR20-CRP response (responder, non-responder) = Treatment + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||12.20|3.56|<0.001
72335155|NCT02308163|144193199|SUPERIORITY||Odds Ratio (OR)|4.79|||<|0.001|TWO_SIDED|95.0|2.14|10.75||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Wald's chi-squared test||Based on logistic regression model: ACR50-CRP response (responder, non-responder) = Treatment + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||10.75|2.14|<0.001
72335156|NCT02308163|144193199|SUPERIORITY||Odds Ratio (OR)|7.86|||<|0.001|TWO_SIDED|95.0|3.53|17.5||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Wald's chi-squared test||Based on logistic regression model: ACR50-CRP response (responder, non-responder) = Treatment + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||17.50|3.53|<0.001
72335157|NCT02308163|144193201|SUPERIORITY||Odds Ratio (OR)|39.93|||<|0.001|TWO_SIDED|95.0|5.29|301.61||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Wald's chi-squared test||Based on logistic regression model: ACR70-CRP response (responder, non-responder) = Treatment + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo. Difference vs. Peficitinib 100mg was not estimable.||301.61|5.29|<0.001
72335158|NCT02308163|144193203|SUPERIORITY||LS mean|-1.06|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|95.0|-1.41|-0.71||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Covariance model||Based on analysis of covariance model: DAS28 Change = Treatment + Baseline DAS28 + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||-0.71|-1.41|<0.001
72335159|NCT02308163|144193203|SUPERIORITY||LS mean|-1.55|STANDARD_ERROR_OF_MEAN|0.16|<|0.001|TWO_SIDED|95.0|-1.86|-1.24||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Covariance model||Based on analysis of covariance model: DAS28 Change = Treatment + Baseline DAS28 + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||-1.24|-1.86|<0.001
72335160|NCT02308163|144193205|SUPERIORITY||LS mean|-1.03|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|95.0|-1.38|-0.67||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Covariance model||Based on analysis of covariance model: DAS28 Change = Treatment + Baseline DAS28 + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||-0.67|-1.38|<0.001
72335161|NCT02308163|144193205|SUPERIORITY||LS mean|-1.64|STANDARD_ERROR_OF_MEAN|0.17|<|0.001|TWO_SIDED|95.0|-1.96|-1.31||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Covariance model||Based on analysis of covariance model: DAS28 Change = Treatment + Baseline DAS28 + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||-1.31|-1.96|<0.001
72425667|NCT03029247|144362975|SUPERIORITY||LS Mean Difference|-97.67||||0.1119|TWO_SIDED|95.0|-219.05|23.71||p-value for the difference between treatment groups was presented from ANCOVA model for the superiority assessment.|ANCOVA||LS Mean treatment difference (daprodustat minus recombinant human erythropoietin) for AUEC of HR and its corresponding 95% CI has been presented.|||23.71|-219.05|0.1119
72425668|NCT01976364|144363029|OTHER||Least Squares (LS) Mean difference|0.0255|||||TWO_SIDED|95.0|-0.0513|0.1022||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Analysis was based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.1022|-0.0513|
72335162|NCT02308163|144193207|SUPERIORITY||LS mean|-4.6|STANDARD_ERROR_OF_MEAN|1.1|<|0.001|TWO_SIDED|95.0|-6.8|-2.4||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Covariance model||Based on analysis of covariance model: TJC68 Change = Treatment + Baseline TJC68 + the prior biologic - DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||-2.4|-6.8|<0.001
72425669|NCT01976364|144363030|OTHER||LS mean difference|0.091|||||TWO_SIDED|95.0|-0.131|0.313||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.313|-0.131|
72335163|NCT02308163|144193207|SUPERIORITY||LS mean|-6.1|STANDARD_ERROR_OF_MEAN|1.0|<|0.001|TWO_SIDED|95.0|-8.1|-4.0||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Covariance model||Based on analysis of covariance model: TJC68 Change = Treatment + Baseline TJC68 + the prior biologic - DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||-4.0|-8.1|<0.001
72425670|NCT01976364|144363064|OTHER||LS Mean Difference|0.0486|||||TWO_SIDED|95.0|-0.0192|0.1163||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 1: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.1163|-0.0192|
72425671|NCT01976364|144363064|OTHER||LS Mean Difference|0.0325|||||TWO_SIDED|95.0|-0.0372|0.1021||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 3: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.1021|-0.0372|
72335164|NCT02308163|144193209|SUPERIORITY||LS mean|-3.0|STANDARD_ERROR_OF_MEAN|0.8|<|0.001|TWO_SIDED|95.0|-4.6|-1.4||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Covariance model||Based on analysis of covariance model: TJC68 Change = Treatment + Baseline TJC68 + the prior biologic - DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||-1.4|-4.6|<0.001
72335165|NCT02308163|144193209|SUPERIORITY||LS mean|-5.3|STANDARD_ERROR_OF_MEAN|0.7|<|0.001|TWO_SIDED|95.0|-6.8|-3.9||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Covariance model||Based on analysis of covariance model: TJC68 Change = Treatment + Baseline TJC68 + the prior biologic - DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||-3.9|-6.8|<0.001
72335166|NCT02308163|144193211|SUPERIORITY||Odds Ratio (OR)|6.4|||<|0.001|TWO_SIDED|95.0|2.31|17.67||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Wald's chi-squared test||Based on logistic regression model: DAS28-CRP score \< 2.6 (responder, non-responder) = Treatment + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||17.67|2.31|<0.001
72335167|NCT02308163|144193211|SUPERIORITY||Odds Ratio (OR)|10.13|||<|0.001|TWO_SIDED|95.0|3.76|27.27||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Wald's chi-squared test||Based on logistic regression model: DAS28-CRP score \< 2.6 (responder, non-responder) = Treatment + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||27.27|3.76|<0.001
72335168|NCT02308163|144193213|SUPERIORITY||Odds Ratio (OR)|21.72||||0.003|TWO_SIDED|95.0|2.83|166.66||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Wald's chi-squared test||Based on logistic regression model: DAS28-ESR score \< 2.6 (responder, non-responder) = Treatment + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo. Difference vs. Peficitinib 100mg was not estimable.||166.66|2.83|0.003
72335169|NCT02308163|144193215|SUPERIORITY||Odds Ratio (OR)|5.8|||<|0.001|TWO_SIDED|95.0|2.74|12.29||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Wald's chi-squared test||Based on logistic regression model: DAS28-CRP score ≤ 3.2 (responder, non-responder) = Treatment + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||12.29|2.74|<0.001
72335170|NCT02308163|144193215|SUPERIORITY||Odds Ratio (OR)|9.66|||<|0.001|TWO_SIDED|95.0|4.57|20.41||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Wald's chi-squared test||Based on logistic regression model: DAS28-CRP score ≤ 3.2 (responder, non-responder) = Treatment + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||20.41|4.57|<0.001
72335171|NCT02308163|144193217|SUPERIORITY||Odds Ratio (OR)|3.24||||0.012|TWO_SIDED|95.0|1.29|8.12||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Wald's chi-squared test||Based on logistic regression model: DAS28-ESR score ≤ 3.2 (responder, non-responder) = Treatment + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||8.12|1.29|0.012
72425672|NCT01976364|144363064|OTHER||LS Mean Difference|-0.0058|||||TWO_SIDED|95.0|-0.0941|0.0825||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 9: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.0825|-0.0941|
72335172|NCT02308163|144193217|SUPERIORITY||Odds Ratio (OR)|8.19|||<|0.001|TWO_SIDED|96.0|3.42|19.63||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Wald's chi-squared test||Based on logistic regression model: DAS28-ESR score ≤ 3.2 (responder, non-responder) = Treatment + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||19.63|3.42|<0.001
72425673|NCT01976364|144363064|OTHER||LS Mean Difference|0.0096|||||TWO_SIDED|95.0|-0.0734|0.0927||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 12: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.0927|-0.0734|
72335173|NCT02308163|144193219|SUPERIORITY||LS Mean|-1.112|STANDARD_ERROR_OF_MEAN|0.22|<|0.001|TWO_SIDED|95.0|-1.546|-0.679||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test|Covariance model||Based on analysis of covariance model: CRP Change = Treatment + Baseline CRP + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||-0.679|-1.546|<0.001
72335174|NCT02308163|144193219|SUPERIORITY||LS mean|-1.677|STANDARD_ERROR_OF_MEAN|0.221|<|0.001|TWO_SIDED|95.0|-2.114|-1.241||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Covariance model||Based on analysis of covariance model: CRP Change = Treatment + Baseline CRP + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||-1.241|-2.114|<0.001
72425674|NCT01976364|144363065|OTHER||LS Mean Difference|0.032|||||TWO_SIDED|95.0|-0.163|0.227||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 1: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.227|-0.163|
72425675|NCT01976364|144363065|OTHER||LS Mean Difference|-0.024|||||TWO_SIDED|95.0|-0.266|0.219||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 3: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.219|-0.266|
72335175|NCT02308163|144193221|SUPERIORITY||LS mean|-10.9|STANDARD_ERROR_OF_MEAN|2.56|<|0.001|TWO_SIDED|95.0|-15.95|-5.84||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Covariance model||Based on analysis of covariance model: ESR Change = Treatment + Baseline ESR + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||-5.84|-15.95|<0.001
72335176|NCT02308163|144193221|SUPERIORITY||LS mean|-21.14|STANDARD_ERROR_OF_MEAN|2.47|<|0.001|TWO_SIDED|95.0|-26.01|-16.27||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Covariance model||Based on analysis of covariance model: ESR Change = Treatment + Baseline ESR + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||-16.27|-26.01|<0.001
72335177|NCT02308163|144193223|SUPERIORITY||Odds Ratio (OR)|6.64|||<|0.001|TWO_SIDED|95.0|2.98|14.83||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Wald's chi-squared test||Based on logistic regression model: Good Response (responder, non-responder) = Treatment + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||14.83|2.98|<0.001
72335178|NCT02308163|144193223|SUPERIORITY||Odds Ratio (OR)|10.86|||<|0.001|TWO_SIDED|95.0|4.91|24.03||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Wald's chi-squared test||Based on logistic regression model: Good Response (responder, non-responder) = Treatment + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||24.03|4.91|<0.001
72335179|NCT02308163|144193225|SUPERIORITY||Odds Ratio (OR)|4.37|||<|0.001|TWO_SIDED|95.0|2.38|8.04||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Wald's chi-squared test||Based on logistic regression model: Good or Moderate Response (responder, non-responder) = Treatment + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||8.04|2.38|<0.001
72335180|NCT02308163|144193225|SUPERIORITY||Odds Ratio (OR)|16.78|||<|0.001|TWO_SIDED|95.0|7.31|38.51||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Wald's chi-squared test||Based on logistic regression model: Good or Moderate Response (responder, non-responder) = Treatment + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||38.51|7.31|<0.001
72335181|NCT02308163|144193227|SUPERIORITY||Odds Ratio (OR)|4.29||||0.006|TWO_SIDED|95.0|1.52|12.08||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Wald's chi-squared test||Based on logistic regression model: Good Response (responder, non-responder) = Treatment + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||12.08|1.52|0.006
72335182|NCT02308163|144193227|SUPERIORITY||Odds Ratio, log|11.01|||<|0.001|TWO_SIDED|95.0|4.07|29.74||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Wald's chi-squared test||Based on logistic regression model: Good Response (responder, non-responder) = Treatment + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||29.74|4.07|<0.001
72335183|NCT02308163|144193229|SUPERIORITY||Odds Ratio (OR)|3.82|||<|0.001||95.0|2.11|6.93||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Wald's chi-squared test||Based on logistic regression model: Good or Moderate Response (responder, non-responder) = Treatment + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||6.93|2.11|<0.001
72335184|NCT02308163|144193229|SUPERIORITY||Odds Ratio (OR)|13.65|||<|0.001|TWO_SIDED|95.0|6.39|29.17||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Wald's chi-squared test||Based on logistic regression model: Good or Moderate Response (responder, non-responder) = Treatment + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||29.17|6.39|<0.001
72335185|NCT02308163|144193235|SUPERIORITY||LS Mean|-9.94|STANDARD_ERROR_OF_MEAN|1.89|<|0.001|TWO_SIDED|95.0|-13.66|-6.22||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Covariance model||Based on analysis of covariance model: SDAI Change = Treatment + Baseline SDAI + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||-6.22|-13.66|<0.001
72335186|NCT02308163|144193235|SUPERIORITY||Odds Ratio (OR)|-14.43|STANDARD_ERROR_OF_MEAN|1.66|<|0.001|TWO_SIDED|95.0|-17.71|-11.15||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Covariance model||Based on analysis of covariance model: SDAI Change = Treatment + Baseline SDAI + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||-11.15|-17.71|<0.001
72335187|NCT02308163|144193239|SUPERIORITY||LS mean|-8.69|STANDARD_ERROR_OF_MEAN|1.77|<|0.001|TWO_SIDED|95.0|-12.19|-5.2||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|ANCOVA||Based on ANCOVA Model: CDAI Change = Treatment + Baseline CDAI + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||-5.20|-12.19|<0.001
72335188|NCT02308163|144193239|SUPERIORITY||LS mean|-12.83|STANDARD_ERROR_OF_MEAN|1.58|<|0.001|TWO_SIDED|95.0|-15.96|-9.71||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|ANCOVA||Based on ANCOVA Model: CDAI Change = Treatment + Baseline CDAI + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||-9.71|-15.96|<0.001
72335189|NCT02308163|144193241|SUPERIORITY||LS mean|-15.2|STANDARD_ERROR_OF_MEAN|3.14|<|0.001|TWO_SIDED|95.0|-21.4|-9.0||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Covariance model||Based on analysis of covariance model: PGA (100 mm VAS) Change = Treatment + Baseline PGA (100 mm VAS) + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||-9.00|-21.40|<0.001
72335190|NCT02308163|144193241|SUPERIORITY||LS mean|-23.14|STANDARD_ERROR_OF_MEAN|2.86|<|0.001|TWO_SIDED|95.0|-28.78|-17.51||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Covariance model||Based on analysis of covariance model: PGA (100 mm VAS) Change = Treatment + Baseline PGA (100 mm VAS) + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||-17.51|-28.78|<0.001
72335191|NCT02308163|144193243|SUPERIORITY||LS mean|-16.88|STANDARD_ERROR_OF_MEAN|3.51|<|0.001|TWO_SIDED|95.0|-23.81|-9.95||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Covariance model||Based on analysis of covariance model: SGA (100 mm VAS) Change = Treatment + Baseline SGA (100 mm VAS) + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||-9.95|-23.81|<0.001
72335192|NCT02308163|144193243|SUPERIORITY||LS mean|-23.56|STANDARD_ERROR_OF_MEAN|3.18|<|0.001|TWO_SIDED|95.0|-29.83|-17.28||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Covariance model||Based on analysis of covariance model: SGA (100 mm VAS) Change = Treatment + Baseline SGA (100 mm VAS) + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||-17.28|-29.83|<0.001
72335193|NCT02308163|144193245|SUPERIORITY||LS mean|-17.58|STANDARD_ERROR_OF_MEAN|3.44|<|0.001|TWO_SIDED|95.0|-24.36|-10.81||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Covariance model||Based on analysis of covariance model: SGA of pain (100 mm VAS) Change = Treatment + Baseline SGA of pain (100 mm VAS) + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||-10.81|-24.36|<0.001
72335194|NCT02308163|144193245|SUPERIORITY||LS mean|-23.9|STANDARD_ERROR_OF_MEAN|3.21|<|0.001|TWO_SIDED|95.0|-30.24|-17.57||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Covariance model||Based on analysis of covariance model: SGA of pain (100 mm VAS) Change = Treatment + Baseline SGA of pain (100 mm VAS) + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||-17.57|-30.24|<0.001
72335195|NCT02308163|144193247|SUPERIORITY|||||||0.033||||||No Multiplicity Adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Fisher Exact|||Treatment Difference vs Placebo||||0.033
72335196|NCT02308163|144193247|SUPERIORITY|||||||0.035||||||No Multiplicity Adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Fisher Exact|||Treatment Difference vs Placebo||||0.035
72335197|NCT02308163|144193248|SUPERIORITY||LS mean|-0.34|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|95.0|-0.48|-0.2||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Covariance model||Based on analysis of covariance model: HAQ-DI Change = Treatment + Baseline HAQ-DI + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea., and Taiwan)|Treatment Difference vs Placebo||-0.20|-0.48|<0.001
72335198|NCT02308163|144193248|SUPERIORITY||LS mean|-0.4|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|95.0|-0.53|-0.26||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Covariance model||Based on analysis of covariance model: HAQ-DI Change = Treatment + Baseline HAQ-DI + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea., and Taiwan)|Treatment Difference vs Placebo||-0.26|-0.53|<0.001
72335199|NCT02308163|144193250|SUPERIORITY||LS mean|6.87|STANDARD_ERROR_OF_MEAN|1.61|<|0.001|TWO_SIDED|95.0|3.69|10.05||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Covariance model||Based on analysis of covariance model: SF-36v2 Change = Treatment + Baseline SF-36v2 + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||10.05|3.69|<0.001
72425676|NCT01976364|144363065|OTHER||LS Mean Difference|0.213|||||TWO_SIDED|95.0|-0.045|0.47||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 9: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.470|-0.045|
72335200|NCT02308163|144193250|SUPERIORITY||LS mean|6.98|STANDARD_ERROR_OF_MEAN|1.45|<|0.001|TWO_SIDED|95.0|4.11|9.85||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Covariance model||Based on analysis of covariance model: SF-36v2 Change = Treatment + Baseline SF-36v2 + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||9.85|4.11|<0.001
72335201|NCT02308163|144193252|SUPERIORITY||LS mean|2.89|STANDARD_ERROR_OF_MEAN|1.0||0.004|TWO_SIDED|95.0|0.91|4.87||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Covariance model||Based on analysis of covariance model: SF-36v2 Change = Treatment + Baseline SF-36v2 + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||4.87|0.91|0.004
72335202|NCT02308163|144193252|SUPERIORITY||LS mean|3.25|STANDARD_ERROR_OF_MEAN|0.98||0.001|TWO_SIDED|95.0|1.3|5.19||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test|Covariance model||Based on analysis of covariance model: SF-36v2 Change = Treatment + Baseline SF-36v2 + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||5.19|1.30|0.001
72335203|NCT02308163|144193254|SUPERIORITY||LS mean|2.27|STANDARD_ERROR_OF_MEAN|1.8||0.21|TWO_SIDED|95.0|-1.29|5.83||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Covariance model||Based on analysis of covariance model: SF-36v2 Change = Treatment + Baseline SF-36v2 + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||5.83|-1.29|0.210
72335204|NCT02308163|144193254|SUPERIORITY||LS mean|6.23|STANDARD_ERROR_OF_MEAN|1.77|<|0.001|TWO_SIDED|95.0|2.74|9.71||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Covariance model||Based on analysis of covariance model: SF-36v2 Change = Treatment + Baseline SF-36v2 + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||9.71|2.74|<0.001
72335205|NCT02308163|144193256|SUPERIORITY||LS mean|-8.55|STANDARD_ERROR_OF_MEAN|3.81||0.027|TWO_SIDED|95.0|-16.11|-1.0||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Covariance model||Based on analysis of covariance model: WPAI Change = Treatment + Baseline WPAI + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||-1.00|-16.11|0.027
72335206|NCT02308163|144193256|SUPERIORITY||LS mean|-10.17|STANDARD_ERROR_OF_MEAN|3.88||0.01|TWO_SIDED|95.0|-17.88|-2.47||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Covariance model||Based on analysis of covariance model: WPAI Change = Treatment + Baseline WPAI + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||-2.47|-17.88|0.010
72335207|NCT02308163|144193258|SUPERIORITY||LS mean|-20.67|STANDARD_ERROR_OF_MEAN|4.92|<|0.001|TWO_SIDED|95.0|-30.44|-10.89||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Covariance model||Based on analysis of covariance model: WPAI Change = Treatment + Baseline WPAI + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||-10.89|-30.44|<0.001
72335208|NCT02308163|144193258|SUPERIORITY||LS mean|-22.01|STANDARD_ERROR_OF_MEAN|5.06|<|0.001|TWO_SIDED|95.0|-32.06|-11.97||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Covariance model||Based on analysis of covariance model: WPAI Change = Treatment + Baseline WPAI + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||-11.97|-32.06|<0.001
72335209|NCT02308163|144193260|SUPERIORITY||LS mean|-20.22|STANDARD_ERROR_OF_MEAN|5.12|<|0.001|TWO_SIDED|95.0|-30.38|-10.06||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test|Covariance model||Based on analysis of covariance model: WPAI Change = Treatment + Baseline WPAI + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||-10.06|-30.38|<0.001
72335210|NCT02308163|144193260|SUPERIORITY||LS mean|-23.67|STANDARD_ERROR_OF_MEAN|5.28|<|0.001|TWO_SIDED|95.0|-34.16|-13.17|||Covariance model|No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Based on analysis of covariance model: WPAI Change = Treatment + Baseline WPAI + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||-13.17|-34.16|<0.001
72335211|NCT02308163|144193262|SUPERIORITY||LS mean|-17.3|STANDARD_ERROR_OF_MEAN|3.39|<|0.001|TWO_SIDED|95.0|-24.0|-10.61||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Covariance model||Based on analysis of covariance model: WPAI Change = Treatment + Baseline WPAI + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||-10.61|-24.00|<0.001
72425677|NCT01976364|144363065|OTHER||LS Mean Difference|-0.061|||||TWO_SIDED|95.0|-0.309|0.188||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 12: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.188|-0.309|
72335212|NCT02308163|144193262|SUPERIORITY||LS mean|-20.41|STANDARD_ERROR_OF_MEAN|3.13|<|0.001|TWO_SIDED|95.0|-26.59|-14.24||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Covariance model||Based on analysis of covariance model: WPAI Change = Treatment + Baseline WPAI + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||-14.24|-26.59|<0.001
72335213|NCT02684058|144193304|SUPERIORITY|one-sided p-value at 2.5% level of significance|Odds Ratio (OR)|7.19|||<|0.001|TWO_SIDED|95.0|2.3|22.4|||Chi-squared|||||22.4|2.3|<0.001
72335214|NCT02684058|144193309|SUPERIORITY||Hazard Ratio (HR)|0.31|||<|0.001|TWO_SIDED|95.0|0.17|0.55||Log-rank test at an overall one-sided 2.5% level of significance|Log Rank|||Up to approx. 3 years||0.55|0.17|<0.001
72335215|NCT05151445|144193364|OTHER||95% CI|-3.56||||0.002|TWO_SIDED|95.0|-5.65|-1.46|||McNemar|||Week 4 vs. Baseline||-1.46|-5.65|0.002
72425678|NCT01976364|144363066|OTHER||Difference in percentage of participants|-0.14|||||TWO_SIDED|95.0|-9.76|9.48||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Month 1: Two-sided 95% CI was based on the normal approximation for the difference in binomial proportions.||9.48|-9.76|
72425679|NCT01976364|144363066|OTHER||Difference in percentage of participants|-4.57|||||TWO_SIDED|95.0|-12.91|3.77||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Month 3: Two-sided 95% CI was based on the normal approximation for the difference in binomial proportions.||3.77|-12.91|
72335216|NCT05151445|144193364|OTHER||95% CI|-3.11||||0.004|TWO_SIDED|95.0|-5.07|-1.15|||McNemar|||Week 8 vs. Baseline||-1.15|-5.07|0.004
72335217|NCT05151445|144193364|OTHER||95% CI|-2.53||||0.038|TWO_SIDED|95.0|-4.9|0.16|||McNemar|||Week 12 vs. Baseline||0.16|-4.90|0.038
72335218|NCT05151445|144193365|OTHER||95% CI|9.61||||0.062|TWO_SIDED|95.0|-0.55|19.77|||McNemar|||Week 4 vs. Baseline||19.77|-0.55|0.062
72335219|NCT05151445|144193365|OTHER||95% CI|9.78||||0.098|TWO_SIDED|95.0|-2.01|21.56|||McNemar|||Week 8 vs. Baseline||21.56|-2.01|0.098
72335220|NCT05151445|144193365|OTHER||95% CI|17.06||||0.003|TWO_SIDED|95.0|6.51|27.6|||McNemar|||Week 12 vs. Baseline||27.60|6.51|0.003
72335221|NCT05151445|144193366|OTHER|||||||0.37|||||||McNemar|||Week 4 vs. Baseline||||0.37
72335222|NCT05151445|144193366|OTHER|||||||0.724|||||||McNemar|||Week 8 vs. Baseline||||0.724
72335223|NCT05151445|144193366|OTHER|||||||0.289|||||||McNemar|||Week 12 vs. Baseline||||0.289
72335224|NCT05151445|144193367|OTHER|||||||1|||||||McNemar|||Week 4 vs. Baseline||||1.000
72335225|NCT05151445|144193367|OTHER|||||||1|||||||McNemar|||Week 8 vs. Baseline||||1.000
72335226|NCT05151445|144193367|OTHER|||||||1|||||||McNemar|||Weel 12 vs. Baseline||||1.000
72335227|NCT05151445|144193368|OTHER||95% CI|-1.1||||0.696|TWO_SIDED|95.0|-6.96|4.76|||McNemar|||Week 4 vs. Baseline||4.76|-6.96|0.696
72335228|NCT05151445|144193368|OTHER||95% CI|-1.08||||0.734|TWO_SIDED|95.0|-7.72|5.56|||McNemar|||Week 8 vs. Baseline||5.56|-7.72|0.734
72335229|NCT05151445|144193368|OTHER||95% CI|-4.15||||0.249|TWO_SIDED|95.0|-11.53|3.23|||McNemar|||Week 12 vs. Baseline||3.23|-11.53|0.249
72335230|NCT05151445|144193369|OTHER||95% CI|-0.04||||0.989|TWO_SIDED|95.0|-5.25|5.18|||McNemar|||Week 4 vs. Baseline||5.18|-5.25|0.989
72335231|NCT05151445|144193369|OTHER||95% CI|3.43||||0.263|TWO_SIDED|95.0|-2.83|9.69|||McNemar|||Week 8 vs. Baseline||9.69|-2.83|0.263
72335232|NCT05151445|144193369|OTHER||Slope|0.44||||0.882|TWO_SIDED|95.0|-5.8|6.68|||McNemar|||Week 12 vs. Baseline||6.68|-5.80|0.882
72335233|NCT05151445|144193370|OTHER||95% CI|-0.62||||0.425|TWO_SIDED|95.0|-2.23|0.98|||McNemar|||Week 4 vs. Baseline||0.98|-2.23|0.425
72335234|NCT05151445|144193370|OTHER||95% CI|-4.98||||0.205|TWO_SIDED|95.0|-9.08|-0.88|||McNemar|||Week 8 vs. Baseline||-0.88|-9.08|0.205
72335235|NCT05151445|144193370|OTHER||95% CI|-4.98||||0.02|TWO_SIDED|95.0|-9.08|-0.8|||McNemar|||Week 12 vs. Baseline||-0.8|-9.08|0.020
72335236|NCT05151445|144193371|OTHER||95% CI|0.429||||0.429|TWO_SIDED|95.0|-4.9|11.01|||McNemar|||Week 4 vs. Baseline||11.01|-4.90|0.429
72335237|NCT05151445|144193371|OTHER||95% CI|-4.39||||0.255|TWO_SIDED|95.0|-12.24|3.46|||McNemar|||Week 8 vs. Baseline||3.46|-12.24|0.255
72335238|NCT05151445|144193371|OTHER||95% CI|-7.0||||0.102|TWO_SIDED|95.0|-15.55|1.55|||McNemar|||Week 12 vs. Baseline||1.55|-15.55|0.102
72335239|NCT05151445|144193372|OTHER||95% CI|-1.94||||0.568|TWO_SIDED|95.0|-8.99|5.1|||McNemar|||Week 4 vs. Baseline||5.10|-8.99|0.568
72335240|NCT05151445|144193372|OTHER||95% CI|-4.11||||0.198|TWO_SIDED|95.0|-10.59|2.37|||McNemar|||Week 8 vs. Baseline||2.37|-10.59|0.198
72335241|NCT05151445|144193372|OTHER||95% CI|-3.76||||0.225|TWO_SIDED|95.0|-10.08|2.55|||McNemar|||Week 12 vs. Baseline||2.55|-10.08|.225
72335242|NCT01730339|144193396|SUPERIORITY_OR_OTHER||Least Square mean difference|0.68|STANDARD_ERROR_OF_MEAN|0.29||0.0219|TWO_SIDED|90.0|0.19|1.16|||Repeated measures model|Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||A total sample size of 100 (accounting for approximately 10% drop rate) that is approximately 50 per group at one sided 0.05 level with delta of 1.5 points with standard deviation of 2 provided at least 80% power to detect a difference from placebo using a paired test. Statistical significance was tested at the two-sided significance level of 0.1, without adjusting for multiplicity.||1.16|0.19|0.0219
72425680|NCT01976364|144363066|OTHER||Difference in percentage of participants|-5.69|||||TWO_SIDED|95.0|-14.26|2.87||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Month 6: Two-sided 95% CI was based on the normal approximation for the difference in binomial proportions.||2.87|-14.26|
72425681|NCT01976364|144363066|OTHER||Difference in percentage of participants|-2.36|||||TWO_SIDED|95.0|-11.59|6.87||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Month 9: Two-sided 95% CI was based on the normal approximation for the difference in binomial proportions.||6.87|-11.59|
72425682|NCT01976364|144363066|OTHER||Difference in percentage of participants|-10.15|||||TWO_SIDED|95.0|-18.16|-2.14||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Month 12: Two-sided 95% CI was based on the normal approximation for the difference in binomial proportions.||-2.14|-18.16|
72425683|NCT01976364|144363067|OTHER||LS mean difference|0.2|||||TWO_SIDED|95.0|-0.1|0.5||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 1: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.5|-0.1|
72425684|NCT01976364|144363067|OTHER||LS mean difference|0.2|||||TWO_SIDED|95.0|-0.1|0.6||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 3: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.6|-0.1|
72335243|NCT01730339|144193396|SUPERIORITY_OR_OTHER||Least Square mean difference|0.24|STANDARD_ERROR_OF_MEAN|0.29||0.4038|TWO_SIDED|90.0|-0.24|0.72|||Repeated measures model|Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||A total sample size of 100 (accounting for approximately 10% drop rate) that is approximately 50 per group at one sided 0.05 level with delta of 1.5 points with standard deviation of 2 provided at least 80% power to detect a difference from placebo using a paired test. Statistical significance was tested at the two-sided significance level of 0.1, without adjusting for multiplicity.||0.72|-0.24|0.4038
72335244|NCT01730339|144193397|SUPERIORITY_OR_OTHER||Least Square mean difference|-0.12|STANDARD_ERROR_OF_MEAN|0.19|||TWO_SIDED|90.0|-0.43|0.2||||||Vascularity: Week 8: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.20|-0.43|
72335245|NCT01730339|144193397|SUPERIORITY_OR_OTHER||Least Square mean difference|-0.16|STANDARD_ERROR_OF_MEAN|0.16|||TWO_SIDED|90.0|-0.43|0.11||||||Vascularity: Week 8: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.11|-0.43|
72335246|NCT01730339|144193397|SUPERIORITY_OR_OTHER||Least Square mean difference|0.19|STANDARD_ERROR_OF_MEAN|0.2|||TWO_SIDED|90.0|-0.15|0.52||||||Vascularity: Week 11: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.52|-0.15|
72335247|NCT01730339|144193397|SUPERIORITY_OR_OTHER||Least Square mean difference|0.07|STANDARD_ERROR_OF_MEAN|0.17|||TWO_SIDED|90.0|-0.22|0.36||||||Vascularity: Week 11: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.36|-0.22|
72335248|NCT01730339|144193397|SUPERIORITY_OR_OTHER||Least Square mean difference|0.42|STANDARD_ERROR_OF_MEAN|0.21|||TWO_SIDED|90.0|0.07|0.77||||||Vascularity: Week 18: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.77|0.07|
72335249|NCT01730339|144193397|SUPERIORITY_OR_OTHER||Least Square mean difference|0.35|STANDARD_ERROR_OF_MEAN|0.18|||TWO_SIDED|90.0|0.05|0.65||||||Vascularity: Week 18: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.65|0.05|
72335250|NCT01730339|144193397|SUPERIORITY_OR_OTHER||Least Square mean difference|0.33|STANDARD_ERROR_OF_MEAN|0.21|||TWO_SIDED|90.0|-0.03|0.68||||||Vascularity: Week 24: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.68|-0.03|
72335251|NCT01730339|144193397|SUPERIORITY_OR_OTHER||Least Square mean difference|0.22|STANDARD_ERROR_OF_MEAN|0.18|||TWO_SIDED|90.0|-0.09|0.52||||||Vascularity: Week 24: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.52|-0.09|
72335252|NCT01730339|144193397|SUPERIORITY_OR_OTHER||Least Square mean difference|0.12|STANDARD_ERROR_OF_MEAN|0.18|||TWO_SIDED|90.0|-0.18|0.42||||||Pigmentation: Week 8: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.42|-0.18|
72335253|NCT01730339|144193397|SUPERIORITY_OR_OTHER||Least Square mean difference|-0.07|STANDARD_ERROR_OF_MEAN|0.17|||TWO_SIDED|90.0|-0.35|0.22||||||Pigmentation: Week 8: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.22|-0.35|
72335254|NCT01730339|144193397|SUPERIORITY_OR_OTHER||Least Square mean difference|-0.11|STANDARD_ERROR_OF_MEAN|0.21|||TWO_SIDED|90.0|-0.47|0.24||||||Pigmentation: Week 11: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.24|-0.47|
72335255|NCT01730339|144193397|SUPERIORITY_OR_OTHER||Least Square mean difference|-0.27|STANDARD_ERROR_OF_MEAN|0.2|||TWO_SIDED|90.0|-0.6|0.06||||||Pigmentation: Week 11: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.06|-0.60|
72335256|NCT01730339|144193397|SUPERIORITY_OR_OTHER||Least Square mean difference|0.03|STANDARD_ERROR_OF_MEAN|0.23|||TWO_SIDED|90.0|-0.35|0.41||||||Pigmentation: Week 18: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.41|-0.35|
72335257|NCT01730339|144193397|SUPERIORITY_OR_OTHER||Least Square mean difference|0.02|STANDARD_ERROR_OF_MEAN|0.21|||TWO_SIDED|90.0|-0.33|0.37||||||Pigmentation: Week 18: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.37|-0.33|
72335258|NCT01730339|144193397|SUPERIORITY_OR_OTHER||Least Square mean difference|0.14|STANDARD_ERROR_OF_MEAN|0.23|||TWO_SIDED|90.0|-0.24|0.53||||||Pigmentation: Week 24: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.53|-0.24|
72335259|NCT01730339|144193397|SUPERIORITY_OR_OTHER||Least Square mean difference|-0.03|STANDARD_ERROR_OF_MEAN|0.21|||TWO_SIDED|90.0|-0.39|0.32||||||Pigmentation: Week 24: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.32|-0.39|
72335260|NCT01730339|144193397|SUPERIORITY_OR_OTHER||Least Square mean difference|0.18|STANDARD_ERROR_OF_MEAN|0.24|||TWO_SIDED|90.0|-0.22|0.58||||||Thickness: Week 8: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.58|-0.22|
72335261|NCT01730339|144193397|SUPERIORITY_OR_OTHER||Least Square mean difference|-0.03|STANDARD_ERROR_OF_MEAN|0.23|||TWO_SIDED|90.0|-0.42|0.35||||||Thickness: Week 8: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.35|-0.42|
72335262|NCT01730339|144193397|SUPERIORITY_OR_OTHER||Least Square mean difference|0.4|STANDARD_ERROR_OF_MEAN|0.27|||TWO_SIDED|90.0|-0.05|0.84||||||Thickness: Week 11: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.84|-0.05|
72335263|NCT01730339|144193397|SUPERIORITY_OR_OTHER||Least Square mean difference|-0.19|STANDARD_ERROR_OF_MEAN|0.25|||TWO_SIDED|90.0|-0.62|0.23||||||Thickness: Week 11: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.23|-0.62|
72335264|NCT01730339|144193397|SUPERIORITY_OR_OTHER||Least Square mean difference|0.94|STANDARD_ERROR_OF_MEAN|0.33|||TWO_SIDED|90.0|0.4|1.49||||||Thickness: Week 18: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||1.49|0.40|
72335265|NCT01730339|144193397|SUPERIORITY_OR_OTHER||Least Square mean difference|0.21|STANDARD_ERROR_OF_MEAN|0.31|||TWO_SIDED|90.0|-0.3|0.72||||||Thickness: Week 18: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.72|-0.30|
72425685|NCT01976364|144363067|OTHER||LS mean difference|0.3|||||TWO_SIDED|95.0|0.0|0.6||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 6: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.6|0.0|
72425686|NCT01976364|144363067|OTHER||LS mean difference|0.5|||||TWO_SIDED|95.0|0.1|0.8||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 9: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.8|0.1|
72425687|NCT01976364|144363067|OTHER||LS mean difference|0.3|||||TWO_SIDED|95.0|-0.1|0.7||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 12: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.7|-0.1|
72425688|NCT01976364|144363068|OTHER||LS mean difference|-19.43|||||TWO_SIDED|95.0|-58.06|19.21||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: At Month 1: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||19.21|-58.06|
72425689|NCT01976364|144363068|OTHER||LS mean difference|-30.11|||||TWO_SIDED|95.0|-83.58|23.37||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: At Month 3: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||23.37|-83.58|
72425690|NCT01976364|144363068|OTHER||LS mean difference|-24.33|||||TWO_SIDED|95.0|-83.35|34.69||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: At Month 6: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||34.69|-83.35|
72425691|NCT01976364|144363068|OTHER||LS mean difference|-11.64|||||TWO_SIDED|95.0|-60.87|37.58||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: At Month 9: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||37.58|-60.87|
72425692|NCT01976364|144363068|OTHER||LS mean difference|7.02|||||TWO_SIDED|95.0|-49.73|63.77||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: At Month 12: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||63.77|-49.73|
72425693|NCT01976364|144363070|OTHER||Difference in percentage of participants|6.25|||||TWO_SIDED|95.0|-59.58|72.08||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Month 1: Two-sided 95% CI was based on the normal approximation for the difference in binomial proportions.||72.08|-59.58|
72425694|NCT01976364|144363070|OTHER||Difference in percentage of participants|6.25|||||TWO_SIDED|95.0|-59.58|72.08||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Month 3: Two-sided 95% CI was based on the normal approximation for the difference in binomial proportions.||72.08|-59.58|
72425695|NCT01976364|144363070|OTHER||Difference in percentage of participants|6.25|||||TWO_SIDED|95.0|-59.58|72.08||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Month 6: Two-sided 95% CI was based on the normal approximation for the difference in binomial proportions.||72.08|-59.58|
72425696|NCT01976364|144363070|OTHER||Difference in percentage of participants|6.25|||||TWO_SIDED|95.0|-59.58|72.08||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Month 9: Two-sided 95% CI was based on the normal approximation for the difference in binomial proportions.||72.08|-59.58|
72335266|NCT01730339|144193397|SUPERIORITY_OR_OTHER||Least Square mean difference|0.68|STANDARD_ERROR_OF_MEAN|0.34|||TWO_SIDED|90.0|0.13|1.24||||||Thickness: Week 24: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||1.24|0.13|
72425697|NCT01976364|144363070|OTHER||Difference in percentage of participants|6.25|||||TWO_SIDED|95.0|-59.58|72.08||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Month 12: Two-sided 95% CI was based on the normal approximation for the difference in binomial proportions.||72.08|-59.58|
72335267|NCT01730339|144193397|SUPERIORITY_OR_OTHER||Least Square mean difference|0.14|STANDARD_ERROR_OF_MEAN|0.32|||TWO_SIDED|90.0|-0.38|0.67||||||Thickness: Week 24: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.67|-0.38|
72335268|NCT01730339|144193397|SUPERIORITY_OR_OTHER||Least Square mean difference|0.39|STANDARD_ERROR_OF_MEAN|0.24|||TWO_SIDED|90.0|-0.01|0.78||||||Relief: Week 8: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.78|-0.01|
72335269|NCT01730339|144193397|SUPERIORITY_OR_OTHER||Least Square mean difference|-0.11|STANDARD_ERROR_OF_MEAN|0.23|||TWO_SIDED|90.0|-0.5|0.28||||||Relief: Week 8: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.28|-0.50|
72425698|NCT01976364|144363071|OTHER||LS mean difference|-0.2|||||TWO_SIDED|95.0|-0.9|0.5||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 1: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.5|-0.9|
72425699|NCT01976364|144363071|OTHER||LS mean difference|-0.2|||||TWO_SIDED|95.0|-0.9|0.5||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 3: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.5|-0.9|
72425700|NCT01976364|144363071|OTHER||LS mean difference|-0.2|||||TWO_SIDED|95.0|-1.1|0.6||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 6: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.6|-1.1|
72425701|NCT01976364|144363071|OTHER||LS mean difference|0.2|||||TWO_SIDED|95.0|-0.6|1.1||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 9: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||1.1|-0.6|
72425702|NCT01976364|144363071|OTHER||LS mean difference|0.2|||||TWO_SIDED|95.0|-0.6|1.0||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 12: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||1.0|-0.6|
72425703|NCT01976364|144363073|OTHER||Difference in percentage of participants|11.67|||||TWO_SIDED|95.0|-15.65|38.98||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Month 1: Two-sided 95% CI was based on the normal approximation for the difference in binomial proportions.||38.98|-15.65|
72425704|NCT01976364|144363073|OTHER||Difference in percentage of participants|30.42|||||TWO_SIDED|95.0|0.64|60.2||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Month 3: Two-sided 95% CI was based on the normal approximation for the difference in binomial proportions.||60.20|0.64|
72425705|NCT01976364|144363073|OTHER||Difference in percentage of participants|29.58|||||TWO_SIDED|95.0|-3.46|62.62||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Month 6: Two-sided 95% CI was based on the normal approximation for the difference in binomial proportions.||62.62|-3.46|
72335270|NCT01730339|144193397|SUPERIORITY_OR_OTHER||Least Square mean difference|0.22|STANDARD_ERROR_OF_MEAN|0.27|||TWO_SIDED|90.0|-0.23|0.67||||||Relief: Week 11: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.67|-0.23|
72425706|NCT01976364|144363073|OTHER||Difference in percentage of participants|24.17|||||TWO_SIDED|95.0|-5.14|53.47||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Month 9: Two-sided 95% CI was based on the normal approximation for the difference in binomial proportions.||53.47|-5.14|
72425707|NCT01976364|144363073|OTHER||Difference in percentage of participants|17.08|||||TWO_SIDED|95.0|-15.96|50.12||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Month 12: Two-sided 95% CI was based on the normal approximation for the difference in binomial proportions.||50.12|-15.96|
72425708|NCT01976364|144363074|OTHER||Difference in percentage of participants|4.99|||||TWO_SIDED|95.0|-9.61|19.6||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Month 1: Two-sided 95% CI was based on the normal approximation for the difference in binomial proportions.||19.60|-9.61|
72335271|NCT01730339|144193397|SUPERIORITY_OR_OTHER||Least Square mean difference|-0.19|STANDARD_ERROR_OF_MEAN|0.26|||TWO_SIDED|90.0|-0.63|0.24||||||Relief: Week 11: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.24|-0.63|
72425709|NCT01976364|144363074|OTHER||Difference in percentage of participants|3.88|||||TWO_SIDED|95.0|-10.74|18.5||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Month 3: Two-sided 95% CI was based on the normal approximation for the difference in binomial proportions.||18.50|-10.74|
72425710|NCT01976364|144363074|OTHER||Difference in percentage of participants|2.82|||||TWO_SIDED|95.0|-11.8|17.45||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Month 6: Two-sided 95% CI was based on the normal approximation for the difference in binomial proportions.||17.45|-11.80|
72335272|NCT01730339|144193397|SUPERIORITY_OR_OTHER||Least Square mean difference|0.74|STANDARD_ERROR_OF_MEAN|0.31|||TWO_SIDED|90.0|0.21|1.26||||||Relief: Week 18: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||1.26|0.21|
72425711|NCT01976364|144363074|OTHER||Difference in percentage of participants|3.97|||||TWO_SIDED|95.0|-10.58|18.52||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Month 9: Two-sided 95% CI was based on the normal approximation for the difference in binomial proportions.||18.52|-10.58|
72335273|NCT01730339|144193397|SUPERIORITY_OR_OTHER||Least Square mean difference|0.09|STANDARD_ERROR_OF_MEAN|0.3|||TWO_SIDED|90.0|-0.41|0.59||||||Relief: Week 18: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.59|-0.41|
72425712|NCT01976364|144363074|OTHER||Difference in percentage of participants|2.87|||||TWO_SIDED|95.0|-11.63|17.37||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Month 12: Two-sided 95% CI was based on the normal approximation for the difference in binomial proportions.||17.37|-11.63|
72335274|NCT01730339|144193397|SUPERIORITY_OR_OTHER||Least Square mean difference|0.52|STANDARD_ERROR_OF_MEAN|0.3|||TWO_SIDED|90.0|0.02|1.02||||||Relief: Week 24: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||1.02|0.02|
72425713|NCT01976364|144363075|OTHER||LS mean difference|-0.4|||||TWO_SIDED|95.0|-1.5|0.6||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 1: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.6|-1.5|
72425714|NCT01976364|144363075|OTHER||LS mean difference|-0.4|||||TWO_SIDED|95.0|-1.6|0.8||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 3: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.8|-1.6|
72425715|NCT01976364|144363075|OTHER||LS mean difference|0.0|||||TWO_SIDED|95.0|-1.0|1.0||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 6: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||1.0|-1.0|
72425716|NCT01976364|144363075|OTHER||LS mean difference|0.0|||||TWO_SIDED|95.0|-0.9|0.9||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 9: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.9|-0.9|
72425717|NCT01976364|144363075|OTHER||LS mean difference|0.2|||||TWO_SIDED|95.0|-0.7|1.1||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 12: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||1.1|-0.7|
72425718|NCT01976364|144363076|OTHER||LS mean difference|0.1|||||TWO_SIDED|95.0|-0.3|0.5||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 1: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.5|-0.3|
72335275|NCT01730339|144193397|SUPERIORITY_OR_OTHER||Least Square mean difference|0.15|STANDARD_ERROR_OF_MEAN|0.29|||TWO_SIDED|90.0|-0.33|0.63||||||Relief: Week 24: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.63|-0.33|
72425719|NCT01976364|144363076|OTHER||LS mean difference|0.0|||||TWO_SIDED|95.0|-0.6|0.6||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 3: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.6|-0.6|
72425720|NCT01976364|144363076|OTHER||LS mean difference|0.0|||||TWO_SIDED|95.0|-0.4|0.5||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 6: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.5|-0.4|
72425721|NCT01976364|144363076|OTHER||LS mean difference|0.2|||||TWO_SIDED|95.0|-0.3|0.7||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 9: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.7|-0.3|
72425722|NCT01976364|144363076|OTHER||LS mean difference|-0.1|||||TWO_SIDED|95.0|-0.5|0.3||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 12: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.3|-0.5|
72425723|NCT01976364|144363077|OTHER||LS mean difference|0.26|||||TWO_SIDED|95.0|-2.51|3.02||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 1: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||3.02|-2.51|
72425724|NCT01976364|144363077|OTHER||LS mean difference|0.77|||||TWO_SIDED|95.0|-2.64|4.18||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 3: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||4.18|-2.64|
72425725|NCT01976364|144363077|OTHER||LS mean difference|0.47|||||TWO_SIDED|95.0|-2.26|3.2||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 6: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||3.20|-2.26|
72425726|NCT01976364|144363077|OTHER||LS mean difference|2.18|||||TWO_SIDED|95.0|-1.46|5.81||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 9: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||5.81|-1.46|
72425727|NCT01976364|144363077|OTHER||LS mean difference|-0.12|||||TWO_SIDED|95.0|-3.25|3.01||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 12: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||3.01|-3.25|
72425728|NCT01976364|144363078|OTHER||LS mean difference|-2.03|||||TWO_SIDED|95.0|-5.58|1.52||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 1: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||1.52|-5.58|
72425729|NCT01976364|144363078|OTHER||LS mean difference|-0.43|||||TWO_SIDED|95.0|-4.69|3.84||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 3: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||3.84|-4.69|
72425730|NCT01976364|144363078|OTHER||LS mean difference|1.29|||||TWO_SIDED|95.0|-3.48|6.06||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 6: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||6.06|-3.48|
72425731|NCT01976364|144363078|OTHER||LS mean difference|0.64|||||TWO_SIDED|95.0|-4.03|5.32||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 9: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||5.32|-4.03|
72425732|NCT01976364|144363078|OTHER||LS mean difference|-0.13|||||TWO_SIDED|95.0|-4.64|4.38||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 12: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||4.38|-4.64|
72425733|NCT01976364|144363079|OTHER||LS mean difference|-1.11|||||TWO_SIDED|95.0|-4.96|2.74||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 1: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||2.74|-4.96|
72425734|NCT01976364|144363079|OTHER||LS mean difference|-1.23|||||TWO_SIDED|95.0|-5.11|2.65||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 3: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||2.65|-5.11|
72425735|NCT01976364|144363079|OTHER||LS mean difference|0.95|||||TWO_SIDED|95.0|-3.78|5.69||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 6: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||5.69|-3.78|
72425736|NCT01976364|144363079|OTHER||LS mean difference|2.01|||||TWO_SIDED|95.0|-2.92|6.93||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 9: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||6.93|-2.92|
72425737|NCT01976364|144363079|OTHER||LS mean difference|0.66|||||TWO_SIDED|95.0|-4.03|5.35||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 12: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||5.35|-4.03|
72425738|NCT01976364|144363080|OTHER||LS mean difference|-0.1535|||||TWO_SIDED|95.0|-2.1444|1.8374||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 1: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||1.8374|-2.1444|
72335276|NCT01730339|144193397|SUPERIORITY_OR_OTHER||Least Square mean difference|0.29|STANDARD_ERROR_OF_MEAN|0.23|||TWO_SIDED|90.0|-0.09|0.67||||||Pliability: Week 8: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.67|-0.09|
72335277|NCT01730339|144193397|SUPERIORITY_OR_OTHER||Least Square mean difference|-0.03|STANDARD_ERROR_OF_MEAN|0.22|||TWO_SIDED|90.0|-0.39|0.34||||||Pliability: Week 8: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.34|-0.39|
72335278|NCT01730339|144193397|SUPERIORITY_OR_OTHER||Least Square mean difference|0.31|STANDARD_ERROR_OF_MEAN|0.26|||TWO_SIDED|90.0|-0.12|0.74||||||Pliability: Week 11: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.74|-0.12|
72335279|NCT01730339|144193397|SUPERIORITY_OR_OTHER||Least Square mean difference|-0.35|STANDARD_ERROR_OF_MEAN|0.25|||TWO_SIDED|90.0|-0.76|0.05||||||Pliability: Week 11: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.05|-0.76|
72425739|NCT01976364|144363080|OTHER||LS mean difference|-0.566|||||TWO_SIDED|95.0|-1.9054|0.7735||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 3: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.7735|-1.9054|
72425740|NCT01976364|144363080|OTHER||LS mean difference|-0.7991|||||TWO_SIDED|95.0|-3.0053|1.4071||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 6: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||1.4071|-3.0053|
72425741|NCT01976364|144363080|OTHER||LS mean difference|0.0626|||||TWO_SIDED|95.0|-1.5767|1.7018||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 9: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||1.7018|-1.5767|
72425742|NCT01976364|144363080|OTHER||LS mean difference|0.3672|||||TWO_SIDED|95.0|-1.8107|2.545||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 12: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||2.5450|-1.8107|
72335280|NCT01730339|144193397|SUPERIORITY_OR_OTHER||Least Square mean difference|0.73|STANDARD_ERROR_OF_MEAN|0.29|||TWO_SIDED|90.0|0.25|1.2||||||Pliability: Week 18: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||1.20|0.25|
72335281|NCT01730339|144193397|SUPERIORITY_OR_OTHER||Least Square mean difference|-0.02|STANDARD_ERROR_OF_MEAN|0.27|||TWO_SIDED|90.0|-0.46|0.42||||||Pliability: Week 18: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.42|-0.46|
72335282|NCT01730339|144193397|SUPERIORITY_OR_OTHER||Least Square mean difference|0.53|STANDARD_ERROR_OF_MEAN|0.31|||TWO_SIDED|90.0|0.01|1.05||||||Pliability: Week 24: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||1.05|0.01|
72335283|NCT01730339|144193397|SUPERIORITY_OR_OTHER||Least Square mean difference|0.49|STANDARD_ERROR_OF_MEAN|0.3|||TWO_SIDED|90.0|0.0|0.98||||||Pliability: Week 24: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.98|0.00|
72335284|NCT01730339|144193397|SUPERIORITY_OR_OTHER||Least Square mean difference|0.17|STANDARD_ERROR_OF_MEAN|0.27|||TWO_SIDED|90.0|-0.29|0.62||||||Surface Area: Week 8: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.62|-0.29|
72335285|NCT01730339|144193397|SUPERIORITY_OR_OTHER||Least Square mean difference|0.08|STANDARD_ERROR_OF_MEAN|0.21|||TWO_SIDED|90.0|-0.28|0.43||||||Surface Area: Week 8: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.43|-0.28|
72425743|NCT01976364|144363081|OTHER||LS mean difference|0.33|||||TWO_SIDED|95.0|-0.85|1.51||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 1: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||1.51|-0.85|
72335286|NCT01730339|144193397|SUPERIORITY_OR_OTHER||Least Square mean difference|0.51|STANDARD_ERROR_OF_MEAN|0.3|||TWO_SIDED|90.0|0.02|1.0||||||Surface Area: Week 11: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||1.00|0.02|
72335287|NCT01730339|144193397|SUPERIORITY_OR_OTHER||Least Square mean difference|-0.15|STANDARD_ERROR_OF_MEAN|0.23|||TWO_SIDED|90.0|-0.53|0.23||||||Surface Area: Week 11: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.23|-0.53|
72335288|NCT01730339|144193397|SUPERIORITY_OR_OTHER||Least Square mean difference|0.64|STANDARD_ERROR_OF_MEAN|0.34|||TWO_SIDED|90.0|0.08|1.2||||||Surface Area: Week 18: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||1.20|0.08|
72335289|NCT01730339|144193397|SUPERIORITY_OR_OTHER||Least Square mean difference|-0.01|STANDARD_ERROR_OF_MEAN|0.26|||TWO_SIDED|90.0|-0.44|0.42||||||Surface Area : Week 18: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.42|-0.44|
72335290|NCT01730339|144193397|SUPERIORITY_OR_OTHER||Least Square mean difference|0.69|STANDARD_ERROR_OF_MEAN|0.36|||TWO_SIDED|90.0|0.09|1.28||||||Surface Area: Week 24: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||1.28|0.09|
72335291|NCT01730339|144193397|SUPERIORITY_OR_OTHER||Least Square mean difference|0.23|STANDARD_ERROR_OF_MEAN|0.28|||TWO_SIDED|90.0|-0.23|0.69||||||Surface Area: week 24: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.69|-0.23|
72335292|NCT01730339|144193397|SUPERIORITY_OR_OTHER||Least Square mean difference|0.24|STANDARD_ERROR_OF_MEAN|0.22||0.2778|TWO_SIDED|90.0|-0.12|0.6|||Repeated measures model|Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||Overall Opinion: Week 8 A total sample size of 100 (accounting for approximately 10% drop rate) that is approximately 50 per group at one sided 0.05 level with delta of 1.5 points with standard deviation of 2 provided at least 80% power to detect a difference from placebo using a paired test. Statistical significance was tested at the two-sided significance level of 0.1, without adjusting for multiplicity.||0.60|-0.12|0.2778
72425744|NCT01976364|144363081|OTHER||LS mean difference|0.33|||||TWO_SIDED|95.0|-1.04|1.69||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 3: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||1.69|-1.04|
72425745|NCT01976364|144363081|OTHER||LS mean difference|-0.77|||||TWO_SIDED|95.0|-2.09|0.55||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 6: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.55|-2.09|
72425746|NCT01976364|144363081|OTHER||LS mean difference|-0.77|||||TWO_SIDED|95.0|-2.44|0.91||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 9: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.91|-2.44|
72425747|NCT01976364|144363081|OTHER||LS mean difference|0.52|||||TWO_SIDED|95.0|-0.96|2.0||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 12: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||2.00|-0.96|
72425748|NCT01976364|144363082|OTHER||LS mean difference|-0.47|||||TWO_SIDED|95.0|-2.22|1.29||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 1: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||1.29|-2.22|
72425749|NCT01976364|144363082|OTHER||LS mean difference|-0.86|||||TWO_SIDED|95.0|-2.65|0.92||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 3: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.92|-2.65|
72425750|NCT01976364|144363082|OTHER||LS mean difference|-0.66|||||TWO_SIDED|95.0|-2.68|1.36||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 6: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||1.36|-2.68|
72425751|NCT01976364|144363082|OTHER||LS mean difference|0.76|||||TWO_SIDED|95.0|-1.31|2.83||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 9: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||2.83|-1.31|
72425752|NCT01976364|144363082|OTHER||LS mean difference|-0.09|||||TWO_SIDED|95.0|-2.01|1.84||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 12: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||1.84|-2.01|
72425753|NCT01976364|144363083|OTHER||LS mean difference|0.22|||||TWO_SIDED|95.0|-1.09|1.53||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 1: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||1.53|-1.09|
72425754|NCT01976364|144363083|OTHER||LS mean difference|0.17|||||TWO_SIDED|95.0|-1.39|1.73||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 3: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||1.73|-1.39|
72425755|NCT01976364|144363083|OTHER||LS mean difference|-0.53|||||TWO_SIDED|95.0|-2.15|1.08||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 6: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||1.08|-2.15|
72425756|NCT01976364|144363083|OTHER||LS mean difference|0.32|||||TWO_SIDED|95.0|-1.49|2.13||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 9: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||2.13|-1.49|
72425757|NCT01976364|144363083|OTHER||LS mean difference|-0.01|||||TWO_SIDED|95.0|-1.89|1.86||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 12: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||1.86|-1.89|
72425758|NCT01976364|144363084|OTHER||LS mean difference|0.48|||||TWO_SIDED|95.0|-1.08|2.05||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 1: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||2.05|-1.08|
72335293|NCT01730339|144193397|SUPERIORITY_OR_OTHER||Least Square mean difference|0.09|STANDARD_ERROR_OF_MEAN|0.22||0.6888|TWO_SIDED|90.0|-0.28|0.45|||Repeated measures model|Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||Overall Opinion: Weekl 8 A total sample size of 100 (accounting for approximately 10% drop rate) that is approximately 50 per group at one sided 0.05 level with delta of 1.5 points with standard deviation of 2 provided at least 80% power to detect a difference from placebo using a paired test. Statistical significance was tested at the two-sided significance level of 0.1, without adjusting for multiplicity.||0.45|-0.28|0.6888
72335294|NCT01730339|144193397|SUPERIORITY_OR_OTHER||Least Square mean difference|0.23|STANDARD_ERROR_OF_MEAN|0.25||0.3515|TWO_SIDED|90.0|-0.18|0.65|||Repeated measures model|Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||Overall Opinion: Weekl 11 A total sample size of 100 (accounting for approximately 10% drop rate) that is approximately 50 per group at one sided 0.05 level with delta of 1.5 points with standard deviation of 2 provided at least 80% power to detect a difference from placebo using a paired test. Statistical significance was tested at the two-sided significance level of 0.1, without adjusting for multiplicity.||0.65|-0.18|0.3515
72335295|NCT01730339|144193397|SUPERIORITY_OR_OTHER||Least Square mean difference|-0.22|STANDARD_ERROR_OF_MEAN|0.25||0.3788|TWO_SIDED|90.0|-0.64|0.19|||Repeated measures model|Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||Overall Opinion: Weekl 11 A total sample size of 100 (accounting for approximately 10% drop rate) that is approximately 50 per group at one sided 0.05 level with delta of 1.5 points with standard deviation of 2 provided at least 80% power to detect a difference from placebo using a paired test. Statistical significance was tested at the two-sided significance level of 0.1, without adjusting for multiplicity.||0.19|-0.64|0.3788
72335296|NCT01730339|144193397|SUPERIORITY_OR_OTHER||Least Square mean difference|0.82|STANDARD_ERROR_OF_MEAN|0.28||0.0044|TWO_SIDED|90.0|0.35|1.29|||Repeated measures model|||Overall Opinion: Weekl 18 A total sample size of 100 (accounting for approximately 10% drop rate) that is approximately 50 per group at one sided 0.05 level with delta of 1.5 points with standard deviation of 2 provided at least 80% power to detect a difference from placebo using a paired test. Statistical significance was tested at the two-sided significance level of 0.1, without adjusting for multiplicity.||1.29|0.35|0.0044
72335297|NCT01730339|144193397|SUPERIORITY_OR_OTHER||Least Square mean difference|0.11|STANDARD_ERROR_OF_MEAN|0.28||0.6848|TWO_SIDED|90.0|-0.35|0.58|||Repeated measures model|||Overall Opinion: Weekl 18 A total sample size of 100 (accounting for approximately 10% drop rate) that is approximately 50 per group at one sided 0.05 level with delta of 1.5 points with standard deviation of 2 provided at least 80% power to detect a difference from placebo using a paired test. Statistical significance was tested at the two-sided significance level of 0.1, without adjusting for multiplicity.||0.58|-0.35|0.6848
72335298|NCT01730339|144193398|SUPERIORITY_OR_OTHER||Least Square mean difference|0.1|STANDARD_ERROR_OF_MEAN|0.32||0.7552|TWO_SIDED|90.0|-0.44|0.64|||Repeated measures model|||Week 8: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.64|-0.44|0.7552
72335299|NCT01730339|144193398|SUPERIORITY_OR_OTHER||LS mean difference|0.11|STANDARD_ERROR_OF_MEAN|0.25||0.6605|TWO_SIDED|90.0|-0.3|0.52|||Repeated measures model|||Week 8: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.52|-0.30|0.6605
72335300|NCT01730339|144193398|SUPERIORITY_OR_OTHER||Least Square mean difference|0.01|STANDARD_ERROR_OF_MEAN|0.33||0.9842|TWO_SIDED|90.0|-0.55|0.56|||Repeated measures model|||Week 11: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.56|-0.55|0.9842
72335301|NCT01730339|144193398|SUPERIORITY_OR_OTHER||Least Square mean difference|0.21|STANDARD_ERROR_OF_MEAN|0.25||0.401|TWO_SIDED|90.0|-0.21|0.63|||Repeated measures model|||Week 11: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.63|-0.21|0.4010
72335302|NCT01730339|144193398|SUPERIORITY_OR_OTHER||Least Square mean difference|0.44|STANDARD_ERROR_OF_MEAN|0.38||0.2491|TWO_SIDED|90.0|-0.19|1.07|||Repeated measures model|||Week 18: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||1.07|-0.19|0.2491
72335303|NCT01730339|144193398|SUPERIORITY_OR_OTHER||Least Square mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.29||0.998|TWO_SIDED|90.0|-0.47|0.47|||Repeated measures model|||Week 18: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.47|-0.47|0.9980
72335304|NCT01730339|144193398|SUPERIORITY_OR_OTHER||Least Square mean difference|0.28|STANDARD_ERROR_OF_MEAN|0.39||0.473|TWO_SIDED|90.0|-0.37|0.93|||Repeated measures model|||Week 24: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.93|-0.37|0.4730
72335305|NCT01730339|144193398|SUPERIORITY_OR_OTHER||Least Square mean difference|-0.18|STANDARD_ERROR_OF_MEAN|0.3||0.5413|TWO_SIDED|90.0|-0.67|0.31|||Repeated measures model|||Week 24: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.31|-0.67|0.5413
72335306|NCT01730339|144193399|SUPERIORITY_OR_OTHER||Least Square mean difference|1.32|STANDARD_ERROR_OF_MEAN|2.76|||TWO_SIDED|90.0|-3.28|5.92||||||Appearance: Week 8: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||5.92|-3.28|
72335307|NCT01730339|144193399|SUPERIORITY_OR_OTHER||LS mean difference|-0.36|STANDARD_ERROR_OF_MEAN|1.97|||TWO_SIDED|90.0|-3.63|2.91||||||Appearance: Week 8: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||2.91|-3.63|
72335308|NCT01730339|144193399|SUPERIORITY_OR_OTHER||Least Square mean difference|3.82|STANDARD_ERROR_OF_MEAN|3.85|||TWO_SIDED|90.0|-2.6|10.24||||||Appearance: Week 24: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||10.24|-2.60|
72335309|NCT01730339|144193399|SUPERIORITY_OR_OTHER||Least Square mean difference|0.16|STANDARD_ERROR_OF_MEAN|2.72|||TWO_SIDED|90.0|-4.37|4.68||||||Appearance: Week 24: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||4.68|-4.37|
72335310|NCT01730339|144193399|SUPERIORITY_OR_OTHER||Least Square mean difference|-0.7|STANDARD_ERROR_OF_MEAN|2.19|||TWO_SIDED|90.0|-4.34|2.95||||||Symptoms: Week 8: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||2.95|-4.34|
72425759|NCT01976364|144363084|OTHER||LS mean difference|1.25|||||TWO_SIDED|95.0|-0.49|2.99||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 3: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||2.99|-0.49|
72425760|NCT01976364|144363084|OTHER||LS mean difference|0.7|||||TWO_SIDED|95.0|-0.91|2.31||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 6: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||2.31|-0.91|
72425761|NCT01976364|144363084|OTHER||LS mean difference|0.2|||||TWO_SIDED|95.0|-1.57|1.96||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 9: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||1.96|-1.57|
72425762|NCT01976364|144363084|OTHER||LS mean difference|1.73|||||TWO_SIDED|95.0|-0.06|3.52||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 12: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||3.52|-0.06|
72425763|NCT01976364|144363085|OTHER||LS mean difference|0.71|||||TWO_SIDED|95.0|-1.01|2.42||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 1: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||2.42|-1.01|
72425764|NCT01976364|144363085|OTHER||LS mean difference|0.34|||||TWO_SIDED|95.0|-1.49|2.18||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 3: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||2.18|-1.49|
72425765|NCT01976364|144363085|OTHER||LS mean difference|-1.81|||||TWO_SIDED|95.0|-3.7|0.09||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 6: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.09|-3.70|
72335311|NCT01730339|144193399|SUPERIORITY_OR_OTHER||Least Square mean difference|-1.54|STANDARD_ERROR_OF_MEAN|1.8|||TWO_SIDED|90.0|-4.53|1.45||||||Symptoms: Week 8: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||1.45|-4.53|
72335312|NCT01730339|144193399|SUPERIORITY_OR_OTHER||Least Square mean difference|1.75|STANDARD_ERROR_OF_MEAN|2.3|||TWO_SIDED|90.0|-2.07|5.58||||||Symptoms: Week 24: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||5.58|-2.07|
72335313|NCT01730339|144193399|SUPERIORITY_OR_OTHER||Least Square mean difference|-1.13|STANDARD_ERROR_OF_MEAN|1.87|||TWO_SIDED|90.0|-4.24|1.99||||||Symptoms: Week 24: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||1.99|-4.24|
72335314|NCT01730339|144193400|SUPERIORITY_OR_OTHER||Least Square mean difference|0.1|STANDARD_ERROR_OF_MEAN|0.15|||TWO_SIDED|90.0|-0.15|0.35||||||Physician: Week 8: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.35|-0.15|
72335315|NCT01730339|144193400|SUPERIORITY_OR_OTHER||Least Square mean difference|0.03|STANDARD_ERROR_OF_MEAN|0.16|||TWO_SIDED|90.0|-0.22|0.29||||||Physician: Week 8: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.29|-0.22|
72425766|NCT01976364|144363085|OTHER||LS mean difference|-1.76|||||TWO_SIDED|95.0|-3.99|0.48||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 9: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.48|-3.99|
72425767|NCT01976364|144363085|OTHER||LS mean difference|-0.3|||||TWO_SIDED|95.0|-2.3|1.69||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 12: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||1.69|-2.30|
72425768|NCT01976364|144363086|OTHER||LS mean difference|-0.68|||||TWO_SIDED|95.0|-2.05|0.69||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 1: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.69|-2.05|
72335316|NCT01730339|144193400|SUPERIORITY_OR_OTHER||Least Square mean difference|0.29|STANDARD_ERROR_OF_MEAN|0.15|||TWO_SIDED|90.0|0.04|0.54||||||Physician: Week 11: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.54|0.04|
72425769|NCT01976364|144363086|OTHER||LS mean difference|-1.13|||||TWO_SIDED|95.0|-2.57|0.31||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 3: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.31|-2.57|
72425770|NCT01976364|144363086|OTHER||LS mean difference|-0.81|||||TWO_SIDED|95.0|-2.17|0.56||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 6: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.56|-2.17|
72425771|NCT01976364|144363086|OTHER||LS mean difference|0.01|||||TWO_SIDED|95.0|-1.54|1.57||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 9: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||1.57|-1.54|
72425772|NCT01976364|144363086|OTHER||LS mean difference|0.04|||||TWO_SIDED|95.0|-1.46|1.53||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 12: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||1.53|-1.46|
72425773|NCT01976364|144363087|OTHER||LS mean difference|-0.36|||||TWO_SIDED|95.0|-2.06|1.35||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 1: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||1.35|-2.06|
72335317|NCT01730339|144193400|SUPERIORITY_OR_OTHER||Least Square mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.15|||TWO_SIDED|90.0|-0.36|0.15||||||Physician: Week 11: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.15|-0.36|
72425774|NCT01976364|144363087|OTHER||LS mean difference|-0.86|||||TWO_SIDED|95.0|-2.51|0.79||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 3: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.79|-2.51|
72425775|NCT01976364|144363087|OTHER||LS mean difference|-1.71|||||TWO_SIDED|95.0|-3.66|0.23||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 6: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.23|-3.66|
72425776|NCT01976364|144363087|OTHER||LS mean difference|-0.47|||||TWO_SIDED|95.0|-2.25|1.32||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 9: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||1.32|-2.25|
72425777|NCT01976364|144363087|OTHER||LS mean difference|0.95|||||TWO_SIDED|95.0|-0.82|2.73||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 12: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||2.73|-0.82|
72425778|NCT01976364|144363088|OTHER||LS mean difference|0.78|||||TWO_SIDED|95.0|-1.27|2.82||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 1: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||2.82|-1.27|
72425779|NCT01976364|144363088|OTHER||LS mean difference|-0.38|||||TWO_SIDED|95.0|-2.46|1.71||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 3: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||1.71|-2.46|
72425780|NCT01976364|144363088|OTHER||LS mean difference|-0.57|||||TWO_SIDED|95.0|-2.72|1.57||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 6: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||1.57|-2.72|
72425781|NCT01976364|144363088|OTHER||LS mean difference|0.28|||||TWO_SIDED|95.0|-1.81|2.36||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 9: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||2.36|-1.81|
72425782|NCT01976364|144363088|OTHER||LS mean difference|0.53|||||TWO_SIDED|95.0|-1.58|2.63||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 12: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||2.63|-1.58|
72425783|NCT01976364|144363089|OTHER||LS mean difference|-1.67|||||TWO_SIDED|95.0|-3.67|0.32||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 1: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.32|-3.67|
72425784|NCT01976364|144363089|OTHER||LS mean difference|-0.61|||||TWO_SIDED|95.0|-2.86|1.63||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 3: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||1.63|-2.86|
72425785|NCT01976364|144363089|OTHER||LS mean difference|-0.09|||||TWO_SIDED|95.0|-2.27|2.09||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 6: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||2.09|-2.27|
72425786|NCT01976364|144363089|OTHER||LS mean difference|0.73|||||TWO_SIDED|95.0|-1.49|2.95||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 9: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||2.95|-1.49|
72425787|NCT01976364|144363089|OTHER||LS mean difference|-0.79|||||TWO_SIDED|95.0|-3.1|1.53||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 12: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||1.53|-3.10|
72425788|NCT01976364|144363090|OTHER||LS mean difference|0.93|||||TWO_SIDED|95.0|-0.95|2.81||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 1: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||2.81|-0.95|
72425789|NCT01976364|144363090|OTHER||LS mean difference|0.11|||||TWO_SIDED|95.0|-1.72|1.95||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 3: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||1.95|-1.72|
72425790|NCT01976364|144363090|OTHER||LS mean difference|-0.25|||||TWO_SIDED|95.0|-2.4|1.9||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 6: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||1.90|-2.40|
72425791|NCT01976364|144363090|OTHER||LS mean difference|1.07|||||TWO_SIDED|95.0|-0.93|3.07||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 9: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||3.07|-0.93|
72425792|NCT01976364|144363090|OTHER||LS mean difference|0.38|||||TWO_SIDED|95.0|-1.62|2.38||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 12: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||2.38|-1.62|
72425793|NCT01976364|144363091|OTHER||LS mean difference|0.8|||||TWO_SIDED|95.0|-0.9|2.5||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 1: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||2.5|-0.9|
72425794|NCT01976364|144363091|OTHER||LS mean difference|0.5|||||TWO_SIDED|95.0|-1.1|2.2||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 3: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||2.2|-1.1|
72425795|NCT01976364|144363091|OTHER||LS mean difference|-0.7|||||TWO_SIDED|95.0|-2.4|1.0||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 6: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||1.0|-2.4|
72425796|NCT01976364|144363091|OTHER||LS mean difference|1.1|||||TWO_SIDED|95.0|-0.8|2.9||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 9: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||2.9|-0.8|
72425797|NCT01976364|144363091|OTHER||LS mean difference|0.8|||||TWO_SIDED|95.0|-1.1|2.6||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 12: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||2.6|-1.1|
72425798|NCT01976364|144363092|OTHER||LS mean difference|0.4|||||TWO_SIDED|95.0|-0.4|1.2||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 1: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||1.2|-0.4|
72425799|NCT01976364|144363092|OTHER||LS mean difference|-0.1|||||TWO_SIDED|95.0|-1.0|0.7||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 3: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.7|-1.0|
72425800|NCT01976364|144363092|OTHER||LS mean difference|-0.7|||||TWO_SIDED|95.0|-1.6|0.1||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 6: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.1|-1.6|
72425801|NCT01976364|144363092|OTHER||LS mean difference|0.0|||||TWO_SIDED|95.0|-0.9|0.8||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 9: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.8|-0.9|
72425802|NCT01976364|144363092|OTHER||LS mean difference|0.0|||||TWO_SIDED|95.0|-0.9|0.8||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 12: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.8|-0.9|
72425803|NCT01976364|144363093|OTHER||LS mean difference|0.5|||||TWO_SIDED|95.0|-0.6|1.6||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 1: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||1.6|-0.6|
72425804|NCT01976364|144363093|OTHER||LS mean difference|0.7|||||TWO_SIDED|95.0|-0.3|1.7||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 3: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||1.7|-0.3|
72425805|NCT01976364|144363093|OTHER||LS mean difference|0.1|||||TWO_SIDED|95.0|-1.0|1.2||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 6: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||1.2|-1.0|
72425806|NCT01976364|144363093|OTHER||LS mean difference|1.2|||||TWO_SIDED|95.0|0.0|2.3||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 9: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||2.3|0.0|
72425807|NCT01976364|144363093|OTHER||LS mean difference|0.8|||||TWO_SIDED|95.0|-0.3|1.9||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 12: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||1.9|-0.3|
72425808|NCT01976364|144363094|OTHER||LS mean difference|0.1|||||TWO_SIDED|95.0|-0.1|0.2||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 1: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.2|-0.1|
72425809|NCT01976364|144363094|OTHER||LS mean difference|0.0|||||TWO_SIDED|95.0|-0.1|0.2||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 3: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.2|-0.1|
72425810|NCT01976364|144363094|OTHER||LS mean difference|0.1|||||TWO_SIDED|95.0|-0.1|0.2||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 6: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.2|-0.1|
72425811|NCT01976364|144363094|OTHER||LS mean difference|0.1|||||TWO_SIDED|95.0|-0.1|0.2||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 9: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.2|-0.1|
72425812|NCT01976364|144363094|OTHER||LS mean difference|0.1|||||TWO_SIDED|95.0|0.0|0.2||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 12: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.2|0.0|
72335318|NCT01730339|144193400|SUPERIORITY_OR_OTHER||Least Square mean difference|0.57|STANDARD_ERROR_OF_MEAN|0.15|||TWO_SIDED|90.0|0.32|0.82||||||Physician: Week 18: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.82|0.32|
72335319|NCT01730339|144193400|SUPERIORITY_OR_OTHER||Least Square mean difference|0.05|STANDARD_ERROR_OF_MEAN|0.15|||TWO_SIDED|90.0|-0.21|0.3||||||Physician: Week 18: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.30|-0.21|
72335320|NCT01730339|144193400|SUPERIORITY_OR_OTHER||Least Square mean difference|0.43|STANDARD_ERROR_OF_MEAN|0.15|||TWO_SIDED|90.0|0.18|0.68||||||Physician: Week 24: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.68|0.18|
72335321|NCT01730339|144193400|SUPERIORITY_OR_OTHER||Least Square mean difference|0.07|STANDARD_DEVIATION|0.15|||TWO_SIDED|90.0|-0.18|0.32||||||Physician: Week 24: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.32|-0.18|
72335322|NCT01730339|144193400|SUPERIORITY_OR_OTHER||Least Square mean difference|0.1|STANDARD_ERROR_OF_MEAN|0.18|||TWO_SIDED|90.0|-0.2|0.39||||||Participant: Week 8: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.39|-0.20|
72335323|NCT01730339|144193400|SUPERIORITY_OR_OTHER||Least Square mean difference|-0.02|STANDARD_ERROR_OF_MEAN|0.15|||TWO_SIDED|90.0|-0.28|0.23||||||Participant: Week 8: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.23|-0.28|
72335324|NCT01730339|144193400|SUPERIORITY_OR_OTHER||Least Square mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.18|||TWO_SIDED|90.0|-0.29|0.3||||||Participant: Week 11: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.30|-0.29|
72335325|NCT01730339|144193400|SUPERIORITY_OR_OTHER||Least Square mean difference|0.07|STANDARD_ERROR_OF_MEAN|0.15|||TWO_SIDED|90.0|-0.18|0.33||||||Participant: Week 11: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.33|-0.18|
72335326|NCT01730339|144193400|SUPERIORITY_OR_OTHER||Least Square mean difference|0.42|STANDARD_ERROR_OF_MEAN|0.18|||TWO_SIDED|90.0|0.12|0.72||||||Participant: Week 18: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.72|0.12|
72335327|NCT01730339|144193400|SUPERIORITY_OR_OTHER||Least Square mean difference|-0.01|STANDARD_ERROR_OF_MEAN|0.15|||TWO_SIDED|90.0|-0.27|0.24||||||Participant: Week 18: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.24|-0.27|
72335328|NCT01730339|144193400|SUPERIORITY_OR_OTHER||Least Square mean difference|0.2|STANDARD_ERROR_OF_MEAN|0.18|||TWO_SIDED|90.0|-0.09|0.5||||||Participant: Week 24: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.50|-0.09|
72335329|NCT01730339|144193400|SUPERIORITY_OR_OTHER||Least Square mean difference|0.15|STANDARD_ERROR_OF_MEAN|0.15|||TWO_SIDED|90.0|-0.11|0.4||||||Participant: Week 24: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.40|-0.11|
72335330|NCT03095027|144193406|NON_INFERIORITY|The pre-specified non-inferiority margin is 0.05. With a sample size of 10, there was approximately 80% power to reject the null hypothesis of inferiority in visual acuity with assumed standard deviation of 0.0474 (one-sided alpha=0.05)|LSM Difference|0.0|STANDARD_ERROR_OF_MEAN|0.0|||ONE_SIDED|95.0||0.01||||||||0.01||
72425813|NCT01976364|144363095|OTHER||LS mean difference|0.0|||||TWO_SIDED|95.0|0.0|0.1||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 1: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.1|0.0|
72425814|NCT01976364|144363095|OTHER||LS mean difference|0.1|||||TWO_SIDED|95.0|0.0|0.2||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 3: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.2|0.0|
72425815|NCT01976364|144363095|OTHER||LS mean difference|0.1|||||TWO_SIDED|95.0|0.0|0.2||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 6: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.2|0.0|
72425816|NCT01976364|144363095|OTHER||LS mean difference|0.0|||||TWO_SIDED|95.0|-0.1|0.1||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 9: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.1|-0.1|
72425817|NCT01976364|144363095|OTHER||LS mean difference|0.0|||||TWO_SIDED|95.0|-0.1|0.1||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 12: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.1|-0.1|
72425818|NCT01976364|144363096|OTHER||LS mean difference|0.0|||||TWO_SIDED|95.0|-0.1|0.1||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 1: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.1|-0.1|
72425819|NCT01976364|144363096|OTHER||LS mean difference|0.1|||||TWO_SIDED|95.0|-0.1|0.2||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 3: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.2|-0.1|
72425820|NCT01976364|144363096|OTHER||LS mean difference|0.1|||||TWO_SIDED|95.0|0.0|0.2||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 6: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.2|0.0|
72425821|NCT01976364|144363096|OTHER||LS mean difference|0.0|||||TWO_SIDED|95.0|-0.1|0.1||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 9: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.1|-0.1|
72425822|NCT01976364|144363096|OTHER||LS mean difference|0.1|||||TWO_SIDED|95.0|-0.1|0.2||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 12: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.2|-0.1|
72425823|NCT01976364|144363097|OTHER||LS mean difference|0.0|||||TWO_SIDED|95.0|-0.1|0.1||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 1: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.1|-0.1|
72425824|NCT01976364|144363097|OTHER||LS mean difference|0.1|||||TWO_SIDED|95.0|-0.1|0.2||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 3: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.2|-0.1|
72425825|NCT01976364|144363097|OTHER||LS mean difference|0.0|||||TWO_SIDED|95.0|-0.1|0.1||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 6: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.1|-0.1|
72425826|NCT01976364|144363097|OTHER||LS mean difference|0.0|||||TWO_SIDED|95.0|-0.1|0.2||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 9: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.2|-0.1|
72425827|NCT01976364|144363097|OTHER||LS mean difference|0.1|||||TWO_SIDED|95.0|-0.1|0.2||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 12: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.2|-0.1|
72335331|NCT00395291|144193441|SUPERIORITY_OR_OTHER||||||<|0.001||||||The IGF-1 data were analyzed on the natural logarithmic scale via a linear mixed model in correspondence to a 2-period crossover design ANCOVA.|ANCOVA|||"Null hypothesis: the intra-subject pre-intervention to post-intervention change in IGF-1 is the same for both the MK-0677 and placebo interventions.~Power calculation: We assumed that the IGF-I data will be lognormally distributed and thus the parameter of interest will be the IGF-1 geometric mean. If n=22 individuals complete the study and the intervention effect is 48% greater for one intervention than the other we will have at least 0.80 power to reject the null hypothesis."||||<0.001
72335332|NCT00395291|144193442|SUPERIORITY_OR_OTHER|||||||0.169|||||||ANCOVA|The Acyl-Ghrelin data were analyzed on the natural logarithmic scale via a linear mixed model in correspondence to a 2-period crossover design ANCOVA.||"Null hypothesis: the intra-subject pre-intervention to post-intervention change in Acyl-Ghrelin is the same for both the MK-0677 and placebo interventions.~Because Acyl-Ghrelin is considered as a secondary outcome, no power analysis was conducted."||||0.169
72335333|NCT00395291|144193443|SUPERIORITY_OR_OTHER|||||||0.063|||||||ANCOVA|The Leptin data were analyzed on the natural logarithmic scale via a linear mixed model in correspondence to a 2-period crossover design ANCOVA.||"Null hypothesis: the intra-subject pre-intervention to post-intervention change in leptin is the same for both the MK-0677 and placebo interventions.~Because Leptin is considered a secondary outcome, no power analysis was conducted."||||0.063
72335334|NCT00395291|144193444|SUPERIORITY_OR_OTHER|||||||0.075|||||||ANCOVA|The insulin data were analyzed on the natural logarithmic scale via a linear mixed model in correspondence to a 2-period crossover design ANCOVA.||"Null hypothesis: the intra-subject pre-intervention to post-intervention change in serum-insulin is the same for both the MK-0677 and placebo interventions.~Because serum-insulin is considered a secondary outcome, no power analysis was conducted."||||0.075
72335335|NCT00395291|144193445|SUPERIORITY_OR_OTHER|||||||0.782||95.0|||||ANCOVA|||||||.782
72425828|NCT01976364|144363098|OTHER||LS mean difference|0.0|||||TWO_SIDED|95.0|-0.2|0.1||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 1: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.1|-0.2|
72335336|NCT00395291|144193446|SUPERIORITY_OR_OTHER|||||||0.385|||||||ANCOVA|The TNF-a data were analyzed on the natural logarithmic scale via a linear mixed model in correspondence to a 2-period crossover design ANCOVA.||"Null hypothesis: the intra-subject pre-intervention to post-intervention change in TNF-a is the same for both the MK-0677 and placebo interventions.~Because Acyl-Ghrelin is considered as a secondary outcome, no power analysis was conducted."||||0.385
72425829|NCT01976364|144363098|OTHER||LS mean difference|0.0|||||TWO_SIDED|95.0|-0.2|0.1||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 3: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.1|-0.2|
72425830|NCT01976364|144363098|OTHER||LS mean difference|-0.1|||||TWO_SIDED|95.0|-0.2|0.1||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 6: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.1|-0.2|
72425831|NCT01976364|144363098|OTHER||LS mean difference|-0.1|||||TWO_SIDED|95.0|-0.3|0.0||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 9: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.0|-0.3|
72425832|NCT01976364|144363098|OTHER||LS mean difference|-0.1|||||TWO_SIDED|95.0|-0.2|0.0||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 12: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.0|-0.2|
72425833|NCT01976364|144363099|OTHER||LS mean difference|-2.9|||||TWO_SIDED|95.0|-6.2|0.4||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 1: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.4|-6.2|
72425834|NCT01976364|144363099|OTHER||LS mean difference|-1.5|||||TWO_SIDED|95.0|-5.8|2.7||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 3: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||2.7|-5.8|
72425835|NCT01976364|144363099|OTHER||LS mean difference|-6.3|||||TWO_SIDED|95.0|-10.2|-2.4||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 6: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||-2.4|-10.2|
72425836|NCT01976364|144363099|OTHER||LS mean difference|-2.8|||||TWO_SIDED|95.0|-7.3|1.6||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 9: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||1.6|-7.3|
72425837|NCT01976364|144363099|OTHER||LS mean difference|-4.9|||||TWO_SIDED|95.0|-9.9|0.2||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 12: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.2|-9.9|
72425838|NCT02318719|144363121|SUPERIORITY||Difference of least square mean|-0.41||||0.017|TWO_SIDED|95.0|-0.74|-0.07||DS-5565 20 mg and 30 mg vs placebo were tested at level of 0.025. If both were significant, 15 mg was tested at 0.05. If neither were significant, 15 mg was no longer tested. If either 20 mg or 30 mg was significant, 15 mg was tested at 0.025.|Mixed Models Analysis|||Placebo vs DS-5565 15 mg/day at Week 14||-0.07|-0.74|0.0170
72425839|NCT02318719|144363121|SUPERIORITY||Difference of least square means|-0.47||||0.0058|TWO_SIDED|95.0|-0.81|-0.14||DS-5565 20 mg and 30 mg vs placebo were tested at level of 0.025. If both were significant, 15 mg was tested at 0.05. If neither were significant, 15 mg was no longer tested. If either 20 mg or 30 mg was significant, 15 mg was tested at 0.025.|Mixed Models Analysis|||Placebo vs DS-5565 20 mg/day at Week 14||-0.14|-0.81|0.0058
72425840|NCT02318719|144363121|SUPERIORITY||Difference of least square means|-0.77|||<|0.0001|TWO_SIDED|95.0|-1.1|-0.44||DS-5565 20 mg and 30 mg vs placebo were tested at level of 0.025. If both were significant, 15 mg was tested at 0.05. If neither were significant, 15 mg was no longer tested. If either 20 mg or 30 mg was significant, 15 mg was tested at 0.025.|Mixed Models Analysis|||Placebo vs DS-5565 30 mg/day at Week 14||-0.44|-1.10|<0.0001
72425841|NCT00423293|144363144|SUPERIORITY_OR_OTHER|||||||0.5|TWO_SIDED|95.0||||One-sided p-value comparing to a rate of 78% (the historical rate was updated after the study design).|Chi-squared|||The RT+ 5-FU + Mitomycin-C arm on previous Radiation Therapy Oncology Group (RTOG) study 9811 \[NCT00003596\] had a 77% rate of \>= grade 2 GI and GU adverse events. The null hypothesis for this study design was a 15% reduction for that rate. Fifty-four evaluable patients provides 80% power to detect a 15% reduction, using a one-sided chi-squared test with a type I error rate of 0.05. (With 52 patients, the power is reduced to 78%.)||||0.50
72425842|NCT00423293|144363146|SUPERIORITY|||||||0.5|||||||Chi-squared|One-sided significance level = 0.05||Percentage of patients with GI grade 2+ adverse events were compared to the historical rate of 73%. Null hypothesis: same or greater than historical rate. Alternative hypothesis: less than historical rate.||||0.5
72425843|NCT00423293|144363146|SUPERIORITY|||||||0.18|||||||Chi-squared|One-sided significance level = 0.05||Percentage of patients with GU grade 2+ adverse events were compared to the historical rate of 20%. Null hypothesis: same or greater than historical rate. Alternative hypothesis: less than historical rate.||||0.18
72425844|NCT00423293|144363146|SUPERIORITY|||||||0.032|||||||Chi-squared|One-sided significance level = 0.05||Percentage of patients with hematologic grade 2+ adverse events were compared to the historical rate of 85%. Null hypothesis: same or greater than historical rate. Alternative hypothesis: less than historical rate.||||0.032
72425845|NCT00423293|144363146|SUPERIORITY|||||||0.1|||||||Chi-squared|One-sided significance level = 0.05||Percentage of patients with skin grade 2+ adverse events were compared to the historical rate of 83%. Null hypothesis: same or greater than historical rate. Alternative hypothesis: less than historical rate.||||0.10
72425846|NCT00423293|144363146|SUPERIORITY|||||||0.12|||||||Chi-squared|One-sided significance level = 0.05||Percentage of patients with any grade 2+ adverse events were compared to the historical rate of 98%. Null hypothesis: same or greater than historical rate. Alternative hypothesis: less than historical rate.||||0.12
72425847|NCT00423293|144363146|SUPERIORITY|||||||0.23|||||||Chi-squared|One-sided significance level = 0.05||Percentage of patients with any grade 3+ adverse events were compared to the historical rate of 87%. Null hypothesis: same or greater than historical rate. Alternative hypothesis: less than historical rate.||||0.23
72425848|NCT03154359|144363260|OTHER|||||||0.197|||||||t-test, 2 sided|||Comparing 6-week responders and 6-week non-responders||||0.197
72425849|NCT03154359|144363260|OTHER|||||||0.562|||||||t-test, 2 sided|||Comparing 18-week responders and 18-week non-responders||||0.562
72425850|NCT03154359|144363261|OTHER|||||||0.558|||||||t-test, 2 sided|||||||0.558
72425851|NCT03154359|144363262|OTHER|||||||0.147|||||||t-test, 2 sided|||||||0.147
72425852|NCT03154359|144363263|OTHER|||||||0.495|||||||t-test, 2 sided|||Comparing 6-week responders and 6-week non-responders||||0.495
72425853|NCT03154359|144363263|OTHER|||||||0.955|||||||t-test, 2 sided|||Comparing 18-week responders and 18-week non-responders||||0.955
72425854|NCT03154359|144363264|OTHER|||||||0.991|||||||t-test, 2 sided|||||||0.991
72425855|NCT03154359|144363265|OTHER|||||||0.759|||||||t-test, 2 sided|||||||0.759
72425856|NCT03154359|144363266|OTHER|||||||0.456|||||||t-test, 2 sided|||Comparing 6-week responders and 6-week non-responders||||0.456
72425857|NCT03154359|144363266|OTHER|||||||0.822|||||||t-test, 2 sided|||Comparing 18-week responders and 18-week non-responders||||0.822
72425858|NCT03154359|144363267|OTHER|||||||0.343|||||||t-test, 2 sided|||||||0.343
72425859|NCT03154359|144363268|OTHER|||||||0.539|||||||t-test, 2 sided|||||||0.539
72425860|NCT03154359|144363269|OTHER|||||||0.13|||||||t-test, 2 sided|||||||0.130
72425861|NCT03154359|144363270|OTHER|||||||0.652|||||||t-test, 2 sided|||||||0.652
72425862|NCT04250337|144363271|SUPERIORITY||Risk Difference (RD)|18.3||||0.011|TWO_SIDED|95.0|5.1|31.5|||Cochran-Mantel-Haenszel|||||31.5|5.1|0.011
72425863|NCT04250337|144363272|SUPERIORITY||Risk Difference (RD)|26.4|||<|0.001|TWO_SIDED|95.0|12.1|40.8|||Cochran-Mantel-Haenszel|||||40.8|12.1|<.001
72425864|NCT04250337|144363273|SUPERIORITY||Risk Difference (RD)|18.9||||0.008|TWO_SIDED|95.0|6.1|31.7|||Cochran-Mantel-Haenszel|||||31.7|6.1|0.008
72425865|NCT04250337|144363274|SUPERIORITY||LS Mean Difference (Final Values)|-15.21|STANDARD_ERROR_OF_MEAN|6.373||0.017263|TWO_SIDED|95.0|-27.7|-2.7|||ANCOVA|||||-2.7|-27.7|0.017263
72425866|NCT04250337|144363275|SUPERIORITY||Risk Difference (RD)|19.2||||0.017|TWO_SIDED|95.0|4.3|34.1|||Cochran-Mantel-Haenszel|||||34.1|4.3|0.017
72425867|NCT04250337|144363276|SUPERIORITY||Risk Difference (RD)|21.6||||0.007|TWO_SIDED|95.0|7.1|36.1|||Cochran-Mantel-Haenszel|||||36.1|7.1|0.007
72425868|NCT04250337|144363277|SUPERIORITY||LS Mean Difference (Final Values)|-23.64|STANDARD_ERROR_OF_MEAN|5.074||3e-06|TWO_SIDED|95.0|-33.6|-13.7|||ANCOVA|||||-13.7|-33.6|0.000003
72425869|NCT04250337|144363278|SUPERIORITY||LS Mean Difference (Final Values)|-12.28|STANDARD_ERROR_OF_MEAN|2.428|<|0.001|TWO_SIDED|95.0|-17.07|-7.49|||Mixed Models Analysis|||||-7.49|-17.07|<0.001
72425870|NCT04250337|144363279|SUPERIORITY||Risk Difference (RD)|3.5||||0.454|TWO_SIDED|95.0|-4.9|11.8|||Cochran-Mantel-Haenszel|||||11.8|-4.9|0.454
72425871|NCT04250337|144363280|SUPERIORITY||Markov Chain Monte Carlo (MCMC)|-20.14|STANDARD_ERROR_OF_MEAN|12.81||0.117607|TWO_SIDED|95.0|-45.4|5.1|||ANCOVA|||||5.1|-45.4|0.117607
72425872|NCT04250337|144363281|SUPERIORITY||Markov Chain Monte Carlo (MCMC)|-0.3|STANDARD_ERROR_OF_MEAN|0.134||0.025293|TWO_SIDED|95.0|-0.6|0.0|||ANCOVA|||||-0.0|-0.6|0.025293
72425873|NCT04250337|144363282|SUPERIORITY||Risk Difference (RD)|14.2||||0.022|TWO_SIDED|95.0|3.8|24.7|||Cochran-Mantel-Haenszel|||||24.7|3.8|0.022
72425874|NCT04250337|144363283|SUPERIORITY||Risk Difference (RD)|1.2||||0.764|TWO_SIDED|95.0|-7.3|9.7|||Cochran-Mantel-Haenszel|||||9.7|-7.3|0.764
72425875|NCT04250337|144363284|SUPERIORITY||Risk Difference (RD)|1.9||||0.498|TWO_SIDED|95.0|-2.9|6.7|||Cochran-Mantel-Haenszel|||||6.7|-2.9|0.498
72425876|NCT04250337|144363285|SUPERIORITY||Risk Difference (RD)|15.6||||0.014|TWO_SIDED|95.0|5.3|25.9|||Cochran-Mantel-Haenszel|||||25.9|5.3|0.014
72425877|NCT04250337|144363286|SUPERIORITY||Risk Difference (RD)|1.1||||0.818|TWO_SIDED|95.0|-8.0|10.2|||Cochran-Mantel-Haenszel|||||10.2|-8.0|0.818
72425878|NCT04250337|144363287|SUPERIORITY||Risk Difference (RD)|2.0||||0.499|TWO_SIDED|95.0|-3.1|7.1|||Cochran-Mantel-Haenszel|||||7.1|-3.1|0.499
72425879|NCT04250337|144363288|SUPERIORITY||LS Mean Difference (Final Values)|7.29|STANDARD_ERROR_OF_MEAN|5.104||0.155|TWO_SIDED|95.0|-2.78|17.36|||Mixed Models Analysis|||||17.36|-2.78|0.155
72425880|NCT04250337|144363290|SUPERIORITY||LS Mean Difference (Final Values)|-17.69|STANDARD_ERROR_OF_MEAN|4.403|<|0.001|TWO_SIDED|95.0|-26.37|-9.01|||ANCOVA|||||-9.01|-26.37|<0.001
72425881|NCT04250337|144363291|SUPERIORITY||LS Mean Difference (Final Values)|-3.33|STANDARD_ERROR_OF_MEAN|1.014||0.001031|TWO_SIDED|95.0|-5.3|-1.3|||ANCOVA|||||-1.3|-5.3|0.001031
72425882|NCT04250337|144363292|SUPERIORITY||Risk Difference (RD)|17.2||||0.036|TWO_SIDED|95.0|0.1|34.3|||Cochran-Mantel-Haenszel|||||34.3|0.1|0.036
72425883|NCT04250337|144363293|SUPERIORITY||LS Mean Difference (Final Values)|0.11|STANDARD_ERROR_OF_MEAN|0.025|<|0.001|TWO_SIDED|95.0|0.06|0.16|||ANCOVA|||Health State Index UK||0.16|0.06|<0.001
72425884|NCT04250337|144363293|SUPERIORITY||LS Mean Difference (Final Values)|0.07|STANDARD_ERROR_OF_MEAN|0.018|<|0.001|TWO_SIDED|95.0|0.04|0.11|||ANCOVA|||Health State Index US||0.11|0.04|<0.001
72425885|NCT04250337|144363294|SUPERIORITY||LS Mean Difference (Final Values)|3.62|STANDARD_ERROR_OF_MEAN|2.386||0.131|TWO_SIDED|95.0|-1.08|8.32|||ANCOVA|||||8.32|-1.08|0.131
72425886|NCT04250337|144363295|SUPERIORITY||LS Mean Difference (Final Values)|-4.0|STANDARD_ERROR_OF_MEAN|1.145|<|0.001|TWO_SIDED|95.0|-6.26|-1.74|||Mixed Models Analysis|||||-1.74|-6.26|<0.001
72425887|NCT04250337|144363296|SUPERIORITY||LS Mean Difference (Final Values)|-0.8|STANDARD_ERROR_OF_MEAN|1.407||0.571|TWO_SIDED|95.0|-3.58|1.98|||ANCOVA|||||1.98|-3.58|0.571
72425888|NCT04250337|144363297|SUPERIORITY||LS Mean Difference (Final Values)|-0.17|STANDARD_ERROR_OF_MEAN|1.127||0.882|TWO_SIDED|95.0|-2.4|2.06|||ANCOVA|||||2.06|-2.40|0.882
72425889|NCT04250337|144363298|SUPERIORITY||LS Mean Difference (Final Values)|3.46|STANDARD_ERROR_OF_MEAN|2.48||0.171|TWO_SIDED|95.0|-1.56|8.48|||ANCOVA|||||8.48|-1.56|0.171
72425890|NCT04250337|144363299|SUPERIORITY||LS Mean Difference (Final Values)|4.43|STANDARD_ERROR_OF_MEAN|2.697||0.109|TWO_SIDED|95.0|-1.03|9.89|||ANCOVA|||||9.89|-1.03|0.109
72425891|NCT04250337|144363300|SUPERIORITY||LS Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.116||0.922|TWO_SIDED|95.0|-0.22|0.24|||ANCOVA|||||0.24|-0.22|0.922
72425892|NCT04250337|144363301|SUPERIORITY||LS Mean Difference (Final Values)|-4.62|STANDARD_ERROR_OF_MEAN|1.271||0.001|TWO_SIDED|95.0|-7.22|-2.03|||Mixed Models Analysis|||||-2.03|-7.22|0.001
72425893|NCT00872430|144363307|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||||||<0.001
72425894|NCT00872430|144363308|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||All data were collected and entered before the opening of the codes of blinding of researchers. We used t test for paired samples and test for repeated measures linear regression for variables with more than two measures.With an improvement of 40% in the tea group and of 20% in the placebo group, with a power (1-ß) of 80% and a alpha error 0.05, it was necessary to include 32 points of comparison, which would be achieved with at least 16 patients, since it's a crossover study.||||<0.001
72425895|NCT02951351|144363309|NON_INFERIORITY|By non-inferiority analysis, proparacaine was inferior to povidone iodine with a 5% margin for non-inferiority. To detect non-inferiority with one positive culture in the proparacaine group, 45 patients would be required in the proparacaine group with a 5% margin.||||||0.28|||||||Wilcoxon (Mann-Whitney)|||||||0.28
72425896|NCT02951351|144363310|SUPERIORITY|||||||0.25|||||||Wilcoxon (Mann-Whitney)|||||||0.25
72425897|NCT02951351|144363311|SUPERIORITY|||||||0.86|||||||Wilcoxon (Mann-Whitney)|||||||0.86
72425898|NCT02951351|144363312|SUPERIORITY|||||||0.48|||||||Wilcoxon (Mann-Whitney)|||||||0.48
72425899|NCT02951351|144363313|SUPERIORITY|||||||0.76|||||||Wilcoxon (Mann-Whitney)|||||||0.76
72425900|NCT02951351|144363314|SUPERIORITY|||||||0.31|||||||Wilcoxon (Mann-Whitney)|||||||0.31
72425901|NCT02951351|144363315|SUPERIORITY|||||||0.18|||||||Wilcoxon (Mann-Whitney)|||||||0.18
72425902|NCT02951351|144363316|SUPERIORITY|||||||0.67|||||||Wilcoxon (Mann-Whitney)|||||||0.67
72425903|NCT01622543|144363334|SUPERIORITY||Hazard Ratio (HR)|1.59||||0.046|TWO_SIDED|95.0|1.0|2.53|||Log Rank|||||2.53|1.00|0.046
72425904|NCT01622543|144363335|SUPERIORITY|||||||0.45|||||||Wilcoxon (Mann-Whitney)|||||||0.45
72425905|NCT01622543|144363336|SUPERIORITY||Odds Ratio (OR)|2.09||||0.06|TWO_SIDED|95.0|0.96|4.55|||Cochran-Mantel-Haenszel|||||4.55|0.96|0.06
72425906|NCT01622543|144363337|SUPERIORITY||Hazard Ratio (HR)|1.24||||0.36|TWO_SIDED|95.0|0.78|1.98|||Log Rank|||||1.98|0.78|0.36
72425907|NCT00365378|144363341|SUPERIORITY_OR_OTHER||Vaccine Efficacy|94.3||||||95.0|87.8|97.7|||||"Vaccine Efficacy (% relative risk reduction)~Confidence Interval based on binomial tail probabilities and not from a dispersion parameter."|||97.7|87.8|
72425908|NCT00365378|144363342|SUPERIORITY_OR_OTHER||Vaccine Efficacy|100.0||||||95.0|84.0|100.0|||||"Vaccine Efficacy (% relative risk reduction)~Confidence Interval based on binomial tail probabilities and not from a dispersion parameter."|||100.0|84.0|
72425909|NCT00058019|144363403|SUPERIORITY_OR_OTHER|||||||0.022||95.0|||||Fisher Exact|||||||0.022
72425910|NCT00058019|144363404|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|||||||1.00
72425911|NCT00058019|144363406|SUPERIORITY_OR_OTHER|||||||0.695|TWO_SIDED|95.0|||||Log Rank|||||||0.695
72425912|NCT00058019|144363407|SUPERIORITY_OR_OTHER|||||||0.55|TWO_SIDED|95.0|||||Log Rank|||||||0.55
72425913|NCT02223065|144363437|NON_INFERIORITY_OR_EQUIVALENCE|The specified bioequivalence limits (0.80, 1.25) for PK measures|Geometric mean ratio|0.975||||0.495|TWO_SIDED|90.0|0.915|1.038|||ANOVA|||||1.038|0.915|0.4950
72425914|NCT02223065|144363438|NON_INFERIORITY_OR_EQUIVALENCE|The specified bioequivalence limits (0.80, 1.25) for PK measures|Geometric mean ratio|0.993||||0.865|TWO_SIDED|90.0|0.932|1.06|||ANOVA|||||1.060|0.932|0.8650
72425915|NCT02223065|144363439|NON_INFERIORITY_OR_EQUIVALENCE|The specified bioequivalence limits (0.80, 1.25) for PK measures|Geometric mean ratio|1.022||||0.2344|TWO_SIDED|90.0|0.991|1.054|||ANOVA|||||1.054|0.991|0.2344
72425916|NCT02223065|144363440|NON_INFERIORITY_OR_EQUIVALENCE|The specified bioequivalence limits (0.80, 1.25) for PK measures|Geometric mean ratio|1.016||||0.2458|TWO_SIDED|90.0|0.993|1.038|||ANOVA|||||1.038|0.993|0.2458
72425917|NCT02223065|144363441|NON_INFERIORITY_OR_EQUIVALENCE|The specified bioequivalence limits (0.80, 1.25) for PK measures|Geometric mean ratio|1.024||||0.1947|TWO_SIDED|90.0|0.993|1.056|||ANOVA|||||1.056|0.993|0.1947
72425918|NCT02223065|144363442|NON_INFERIORITY_OR_EQUIVALENCE|The specified bioequivalence limits (0.80, 1.25) for PK measures|Geometric mean ratio|1.013||||0.3191|TWO_SIDED|90.0|0.992|1.034|||ANOVA|||||1.034|0.992|0.3191
72335337|NCT00395291|144193447|SUPERIORITY_OR_OTHER|||||||0.929|||||||ANCOVA|The CRPs data were analyzed on the natural logarithmic scale via a linear mixed model in correspondence to a 2-period crossover design ANCOVA.||"Null hypothesis: the intra-subject pre-intervention to post-intervention change in CRPs is the same for both the MK-0677 and placebo interventions.~Because CRPs is considered as a secondary outcome, no power analysis was conducted."||||0.929
72335338|NCT00395291|144193448|SUPERIORITY_OR_OTHER|||||||0.905|||||||ANCOVA|The IL-1 data were analyzed on the natural logarithmic scale via a linear mixed model in correspondence to a 2-period crossover design ANCOVA.||"Null hypothesis: the intra-subject pre-intervention to post-intervention change in IL-1 is the same for both the MK-0677 and placebo interventions.~Because IL-1 is considered as a secondary outcome, no power analysis was conducted"||||0.905
72335339|NCT00395291|144193449|SUPERIORITY_OR_OTHER|||||||0.233||95.0|||||ANCOVA|||||||0.233
72335340|NCT00395291|144193450|SUPERIORITY_OR_OTHER|||||||0.277|||||||ANCOVA|The IL-10 data were analyzed on the natural logarithmic scale via a linear mixed model in correspondence to a 2-period crossover design ANCOVA.||"Null hypothesis: the intra-subject pre-intervention to post-intervention change in IL-10 is the same for both the MK-0677 and placebo interventions.~Because IL-10 is considered as a secondary outcome, no power analysis was conducted."||||0.277
72335341|NCT00395291|144193451|SUPERIORITY_OR_OTHER|||||||0.875|||||||ANCOVA|The esterase data were analyzed on the natural logarithmic scale via a linear mixed model in correspondence to a 2-period crossover design ANCOVA.||"Null hypothesis: the intra-subject pre-intervention to post-intervention change in esterase is the same for both the MK-0677 and placebo interventions.~Because Acyl-Ghrelin is considered as a secondary outcome, no power analysis was conducted."||||0.875
72335342|NCT00395291|144193452|SUPERIORITY_OR_OTHER|||||||0.545|||||||ANCOVA|The adiponectin data were analyzed on the natural logarithmic scale via a linear mixed model in correspondence to a 2-period crossover design ANCOVA.||"Null hypothesis: the intra-subject pre-intervention to post-intervention change in adiponectin is the same for both the MK-0677 and placebo interventions.~Because Acyl-Ghrelin is considered as a secondary outcome, no power analysis was conducted."||||0.545
72335343|NCT00395291|144193453|SUPERIORITY_OR_OTHER|||||||0.9|||||||ANCOVA|Total ghrelin data were analyzed on the natural logarithmic scale via a linear mixed model in correspondence to a 2-period crossover design ANCOVA.||"Null hypothesis: the intra-subject pre-intervention to post-intervention change in Total-Ghrelin is the same for both the MK-0677 and placebo interventions.~Because Acyl-Ghrelin is considered as a secondary outcome, no power analysis was conducted."||||0.900
72335344|NCT01962987|144193454|EQUIVALENCE|90% confidence interval of the difference in the percentage of patients between Test and Reference to be contained within -20%, + 20%, using the Per-Protocol Population.|(Test-Ref) Difference|0.68|||||TWO_SIDED|90.0|-8.06|9.42|||||Applicable to Percentage of Subjects with Cure (100% complete AK clearance at day 90)|||9.42|-8.06|
72335345|NCT01962987|144193454|SUPERIORITY|||||||0.001|||||||ANOVA|||||||0.0010
72335346|NCT00523705|144193494|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.57|STANDARD_ERROR_OF_MEAN|4.86||0.467|TWO_SIDED||||||Regression, Linear||estimate of main effect of treatment in a linear mixed effects model.|Pilot data were examined at treatment endpoint for change from baseline. Statistical power was very low due to the small sample size.||||0.467
72335347|NCT01180036|144193535|SUPERIORITY||Risk Difference (RD)|40.0||||0.001|TWO_SIDED|95.0|24.6|55.4|||Chi-squared|||||55.4|24.6|0.001
72335348|NCT01180036|144193536|NON_INFERIORITY|With a non-inferiority margin of 15%. enrollment of 63 evaluable patients per study are is required to achieve 80% power to show that RTX is not inferior.||||||0.009|||||||Chi-squared|||||||0.009
72335349|NCT04243577|144193537|EQUIVALENCE|Margins for this test were calculated as plus or minus half a standard deviation using preliminary data acquired with the conventional electrodes, which were considered as the current gold standard and were ± 3.1.|||||<|0.025||||||Alpha level based on Bonferroni correction was set to .025 to correct for multiple comparisons.|t-test, 2 sided|||For Iteration 1 testing, we hypothesized that normalized amplitude during swallow trials obtained using the conventional sensors and the experimental sensors will be equivalent. Alpha level was set to .025 to correct for multiple comparisons.||||<0.025
72335350|NCT04243577|144193537|EQUIVALENCE|Margins for this test were based on the absolute value of the effect size (Cohen's d) being smaller than 0.5.|||||<|0.025||||||Alpha level based on Bonferroni correction was set to .025 to correct for multiple comparisons.|Bootstrapping CIs|In this 2nd iteration testing, we are accounting for variance uncertainty, and thus bootstrapping a Confidence Interval for Cohen's d.||For Iteration 2 testing again, we hypothesized that normalized amplitude during swallow trials obtained using the conventional sensors and the experimental sensors will be equivalent. Alpha level was set to .025 to correct for multiple comparisons.||||<0.025
72335351|NCT04243577|144193538|NON_INFERIORITY|Margin for this test was calculated as minus half a standard deviation using preliminary data acquired with the conventional electrodes, which were considered as the current gold standard and was -.99.|||||<|0.025||||||Alpha level based on Bonferroni correction was set to .025 to correct for multiple comparisons.|t-test, 1 sided|||For Iteration 1 testing, we hypothesized that Signal to Noise Ratio (SNR) obtained using the experimental sensors will not be inferior to the Signal to Noise Ratio (SNR) obtained using the conventional sensors. Alpha level was set to .025 to correct for multiple comparisons.||||<0.025
72335352|NCT04243577|144193538|NON_INFERIORITY|Margin for this test was based on the effect size (Cohen's d) being larger than -0.5.|||||<|0.025||||||Alpha level based on Bonferroni correction was set to .025 to correct for multiple comparisons.|Bootstrapping CIs|In this 2nd iteration testing, we are accounting for variance uncertainty, and thus bootstrapping a one-sided confidence bound for Cohen's d.||For Iteration 2 testing, we again hypothesized that Signal to Noise Ratio (SNR) obtained using the newer version of the experimental sensors will not be inferior to the Signal to Noise Ratio (SNR) obtained using the conventional sensors. Alpha level was set to .025 to correct for multiple comparisons.||||<0.025
72335353|NCT04243577|144193539|SUPERIORITY||||||<|0.05|||||||t-test, 1 sided|Paired t-test||For Iteration 1 testing, we hypothesized that ease of use/comfort expressed after using the experimental patch will be higher than the one reported using the conventional electrodes. Alpha level was set to .05.||||<0.05
72425919|NCT01614847|144363445|EQUIVALENCE|Two tailed, alpha = 0.05||||||0.4|||||||Wilcoxon (Mann-Whitney)|df=7||Drop A: Mean change in osmolarity from baseline H0: No osmolarity change from baseline (e.g. mean change = 0) H1: Significant osmolarity change from baseline (mean change ≠ 0)||||0.4
72425920|NCT01614847|144363445|EQUIVALENCE|two-tailed, alpha = 0.05||||||0.109|||||||Wilcoxon (Mann-Whitney)|df=7||Drop A: Mean change in osmolarity from baseline H0: No osmolarity change from baseline (e.g. mean change = 0) H1: Significant osmolarity change from baseline (mean change ≠ 0)||||0.109
72425921|NCT01614847|144363445|EQUIVALENCE|Two tailed, alpha = 0.05||||||0.779|||||||Wilcoxon (Mann-Whitney)|df=7||Drop A: Mean change in osmolarity from baseline H0: No osmolarity change from baseline (e.g. mean change = 0) H1: Significant osmolarity change from baseline (mean change ≠ 0)||||0.779
72425922|NCT01614847|144363445|EQUIVALENCE|Two tailed, alpha = 0.05||||||0.262|||||||Wilcoxon (Mann-Whitney)|df=7||Drop A: Mean change in osmolarity from baseline H0: No osmolarity change from baseline (e.g. mean change = 0) H1: Significant osmolarity change from baseline (mean change ≠ 0)||||0.262
72425923|NCT01614847|144363445|EQUIVALENCE|Two tailed, alpha = 0.05||||||0.15|||||||Wilcoxon (Mann-Whitney)|df=7||Drop A: Mean change in osmolarity from baseline H0: No osmolarity change from baseline (e.g. mean change = 0) H1: Significant osmolarity change from baseline (mean change ≠ 0)||||0.150
72425924|NCT01614847|144363445|EQUIVALENCE|Two tailed, alpha = 0.05||||||0.726|||||||Wilcoxon (Mann-Whitney)|df=7||Drop A: Mean change in osmolarity from baseline H0: No osmolarity change from baseline (e.g. mean change = 0) H1: Significant osmolarity change from baseline (mean change ≠ 0)||||0.726
72425925|NCT01614847|144363445|EQUIVALENCE|Two tailed, alpha = 0.05||||||0.055|||||||Wilcoxon (Mann-Whitney)|df=7||Drop A: Mean change in osmolarity from baseline H0: No osmolarity change from baseline (e.g. mean change = 0) H1: Significant osmolarity change from baseline (mean change ≠ 0)||||0.055
72425926|NCT01614847|144363445|EQUIVALENCE|Two tailed, alpha = 0.05||||||0.945|||||||Wilcoxon (Mann-Whitney)|df=7||Drop B: Mean change in osmolarity from baseline H0: No osmolarity change from baseline (e.g. mean change = 0) H1: Significant osmolarity change from baseline (mean change ≠ 0)||||0.945
72425927|NCT01614847|144363445|EQUIVALENCE|Alpha = 0.05||||||0.844|||||||Wilcoxon (Mann-Whitney)|df=7||Drop B: Mean change in osmolarity from baseline H0: No osmolarity change from baseline (e.g. mean change = 0) H1: Significant osmolarity change from baseline (mean change ≠ 0)||||0.844
72425928|NCT01614847|144363445|EQUIVALENCE|Two tailed, alpha = 0.05||||||0.945||||||df=7|Wilcoxon (Mann-Whitney)|||Drop B: Mean change in osmolarity from baseline H0: No osmolarity change from baseline (e.g. mean change = 0) H1: Significant osmolarity change from baseline (mean change ≠ 0)||||0.945
72425929|NCT01614847|144363445|EQUIVALENCE|Two tailed, alpha = 0.05||||||0.383||||||Alpha = 0.05|Wilcoxon (Mann-Whitney)|df=7||Drop B: Mean change in osmolarity from baseline H0: No osmolarity change from baseline (e.g. mean change = 0) H1: Significant osmolarity change from baseline (mean change ≠ 0)||||0.383
72425930|NCT01614847|144363445|EQUIVALENCE|Two tailed, alpha = 0.05||||||0.383|||||||Wilcoxon (Mann-Whitney)|df=7||Mean change in osmolarity from baseline. H0: No change (e.g. mean change = 0) H1: Significant change (mean change ≠ 0)||||0.383
72425931|NCT01614847|144363445|EQUIVALENCE|Two tailed, alpha = 0.05||||||0.672|||||||Wilcoxon (Mann-Whitney)|df=7||Drop B: Mean change in osmolarity from baseline H0: No osmolarity change from baseline (e.g. mean change = 0) H1: Significant osmolarity change from baseline (mean change ≠ 0)||||0.672
72425932|NCT01614847|144363445|EQUIVALENCE|Two tailed, alpha = 0.05||||||0.107|||||||Wilcoxon (Mann-Whitney)|df=7||Drop B: Mean change in osmolarity from baseline H0: No osmolarity change from baseline (e.g. mean change = 0) H1: Significant osmolarity change from baseline (mean change ≠ 0)||||0.107
72425933|NCT01614847|144363445|EQUIVALENCE|Two tailed, alpha = 0.05||||||0.64|||||||Wilcoxon (Mann-Whitney)|df=12||Comparison of Drop A versus Drop B change in osmolarity at this point in time. H0: No difference in osmolarity change between Drop A and B (Drop A = Drop B) H1: Significant difference in osmolarity change between Drop A and Drop B||||0.64
72425934|NCT01614847|144363445|EQUIVALENCE|Two tailed, alpha = 0.05||||||0.04|||||||Wilcoxon (Mann-Whitney)|df=14||Comparison of Drop A versus Drop B change in osmolarity at this point in time. H0: No difference in osmolarity change between Drop A and B (Drop A = Drop B) H1: Significant difference in osmolarity change between Drop A and Drop B||||0.040
72425935|NCT01614847|144363445|EQUIVALENCE|Two tailed, alpha = 0.05||||||0.2|||||||Wilcoxon (Mann-Whitney)|df=12||Comparison of Drop A versus Drop B change in osmolarity at this point in time. H0: No difference in osmolarity change between Drop A and B (Drop A = Drop B) H1: Significant difference in osmolarity change between Drop A and Drop B||||0.20
72425936|NCT01614847|144363445|EQUIVALENCE|Two tailed, alpha = 0.05||||||0.15|||||||Wilcoxon (Mann-Whitney)|df-=12||Comparison of Drop A versus Drop B change in osmolarity at this point in time. H0: No difference in osmolarity change between Drop A and B (Drop A = Drop B) H1: Significant difference in osmolarity change between Drop A and Drop B||||0.150
72425937|NCT01614847|144363445|EQUIVALENCE|Two tailed, alpha = 0.05||||||0.73|||||||Wilcoxon (Mann-Whitney)|df=12||Comparison of Drop A versus Drop B change in osmolarity at this point in time. H0: No difference in osmolarity change between Drop A and B (Drop A = Drop B) H1: Significant difference in osmolarity change between Drop A and Drop B||||0.730
72425938|NCT01614847|144363445|EQUIVALENCE|Two tailed, alpha = 0.05||||||0.89|||||||Wilcoxon (Mann-Whitney)|df=12||Comparison of Drop A versus Drop B change in osmolarity at this point in time. H0: No difference in osmolarity change between Drop A and B (Drop A = Drop B) H1: Significant difference in osmolarity change between Drop A and Drop B||||0.89
72425939|NCT01614847|144363445|EQUIVALENCE|Two tailed, alpha = 0.05||||||0.89|||||||Wilcoxon (Mann-Whitney)|df=12||Comparison of Drop A versus Drop B change in osmolarity at this point in time. H0: No difference in osmolarity change between Drop A and B (Drop A = Drop B) H1: Significant difference in osmolarity change between Drop A and Drop B||||0.89
72425940|NCT00249496|144363446|SUPERIORITY||Odds Ratio (OR)|3.73||||0.004|TWO_SIDED|95.0|1.6|8.69|||General Estimating Equation (GEE)|||||8.69|1.60|.004
72425941|NCT00249496|144363448|SUPERIORITY||Odds Ratio (OR)|0.8|||=|0.57|TWO_SIDED|95.0|0.26|2.43|||General Estimating Equation (GEE)|||||2.43|0.26|=0.57
72335354|NCT04243577|144193539|SUPERIORITY||||||<|0.05|||||||t-test, 1 sided|Paired t-test||For Iteration 2 testing, again we hypothesized that ease of use/comfort expressed after using the experimental patch will be higher than the one reported using the conventional electrodes. Alpha level was set to .05.||||<0.05
72335355|NCT01679600|144193541|SUPERIORITY_OR_OTHER|||||||0.53|TWO_SIDED||||||F1-LD-F1 model by Brunner and Langer|||||||0.53
72335356|NCT00385944|144193548|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-12.91|||<|0.001|TWO_SIDED|95.0|-17.02|-8.81|||Mixed Models Analysis|||||-8.81|-17.02|<0.001
72425942|NCT00249496|144363450|SUPERIORITY||Odds Ratio (OR)|0.0||||0.046|TWO_SIDED|95.0|0.0|0.0|||General Estimating Equation (GEE)||The Odds Ratio and Confidence Intervals could not be calculated because one of the groups was at 0.|||0|0|0.046
72425943|NCT03292146|144363466|SUPERIORITY|||||||0.009|||||||Mixed Models Analysis|||||||0.009
72425944|NCT03292146|144363467|SUPERIORITY|||||||0.41|||||||t-test, 2 sided|||||||0.41
72425945|NCT03292146|144363468|SUPERIORITY|||||||0.06|||||||Matched pairs|||||||0.06
72335357|NCT00385944|144193549|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-7.81|||<|0.001|TWO_SIDED|95.0|-10.96|-4.65|||Mixed Models Analysis|||||-4.65|-10.96|<0.001
72425946|NCT03292146|144363468|SUPERIORITY|||||||0.01|||||||Matched pairs|||||||0.01
72335358|NCT00385944|144193550|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-11.98|||<|0.001|TWO_SIDED|95.0|-17.06|-6.9|||Mixed Models Analysis|||||-6.90|-17.06|<0.001
72335359|NCT00385944|144193551|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.3||||0.001|TWO_SIDED|95.0|-6.84|-1.76|||Mixed Models Analysis|||||-1.76|-6.84|0.001
72335360|NCT00385944|144193552|SUPERIORITY_OR_OTHER||Mean Difference (Net)|15.16|||<|0.001|TWO_SIDED|95.0|7.05|23.26|||Mixed Models Analysis|||||23.26|7.05|<0.001
72335361|NCT00385944|144193553|SUPERIORITY_OR_OTHER||Mean Difference (Net)|12.69||||0.001|TWO_SIDED|95.0|5.56|19.81|||Mixed Models Analysis|||||19.81|5.56|0.001
72335362|NCT00385944|144193554|SUPERIORITY_OR_OTHER||Mean Difference (Net)|10.26||||0.015|TWO_SIDED|95.0|2.17|18.34|||Mixed Models Analysis|||||18.34|2.17|0.015
72335363|NCT00385944|144193555|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.85||||0.123|TWO_SIDED|95.0|-1.13|8.84|||Mixed Models Analysis|||||8.84|-1.13|0.123
72335364|NCT00385944|144193556|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-16.83|||<|0.001|TWO_SIDED|95.0|-23.05|-10.62|||Mixed Models Analysis|||||-10.62|-23.05|<0.001
72335365|NCT00385944|144193557|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-54.44|||<|0.001|TWO_SIDED|95.0|-70.87|-38.01|||Mixed Models Analysis|||||-38.01|-70.87|<0.001
72335366|NCT00385944|144193559|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-35.5|||<|0.001||95.0|||||two-sided paired t-test|||||||<.001
72335367|NCT00385944|144193560|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-9.0||||0.011||95.0|||||two-sided paired t-test|||Paired t-test for each arm separately||||0.011
72335368|NCT00385944|144193560|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.6||||0.847||95.0|||||two-sided paired t-test|||Paired t-test for each arm separately||||0.847
72335369|NCT00385944|144193561|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-9.24||||0.008|TWO_SIDED|95.0|-15.99|-2.49|||t-test, 2 sided|||||-2.49|-15.99|0.008
72335370|NCT00385944|144193562|SUPERIORITY_OR_OTHER||Median Difference (Net)|17.52|||<|0.001|TWO_SIDED|95.0|9.22|25.83|||t-test, 2 sided|||||25.83|9.22|<0.001
72335371|NCT00834990|144193589|NON_INFERIORITY_OR_EQUIVALENCE|The pharmacokinetic parameters were evaluated statistically by an analysis of variance (ANOVA) appropriate for the experimental design of this study.|Ratio of the T/R geometric mean x 100|103.41||||||90.0|97.13|110.08|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||110.08|97.13|
72335372|NCT00834990|144193590|NON_INFERIORITY_OR_EQUIVALENCE|The pharmacokinetic parameters were evaluated statistically by an analysis of variance (ANOVA) appropriate for the experimental design of this study.|Ratio of the T/R geometric mean x 100|101.68||||||90.0|96.79|106.83|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||106.83|96.79|
72425947|NCT00545363|144363471|SUPERIORITY_OR_OTHER||||||=|0.8989|||||||ANOVA|||Statistical analysis was done to compare the participant satisfaction between the Biofeedback and No-feedback arms.||||=0.8989
72425948|NCT00545363|144363472|SUPERIORITY_OR_OTHER||||||=|0.453|||||||ANOVA|||Statistical analysis was done to compare the participant perception between the Biofeedback and No-feedback arms.||||=0.453
72425949|NCT00545363|144363473|SUPERIORITY_OR_OTHER||||||=|0.4917|||||||ANOVA|||Statistical analysis was done to compare the effect of adherence (Yes/No) on percent change from baseline in CTX between the Biofeedback and No-feedback arms.||||=0.4917
72425950|NCT00366301|144363474|SUPERIORITY_OR_OTHER||Percent Change in Log CRP|20.0|STANDARD_ERROR_OF_MEAN|10.0|<|0.05|TWO_SIDED|95.0|||||Mixed Models Analysis|Adjusted models included terms for baseline HbA1c and weight and change in weight at each time point.||As hsCRP was measured at both 6 and 14 weeks, linear mixed models conditioning on baseline hsCRP and adjusting for treatment stratum were constructed with the dependent variable being change in lnCRP. The means at each time point were estimated from a repeated-measures model incorporating all 3 time points. The interventions were assessed by fitting terms corresponding to study drug and treatment arm assignment.||||<0.05
72425951|NCT02354963|144363480|SUPERIORITY|||||||0.302|||||||Wilcoxon (Mann-Whitney)|||||||0.302
72425952|NCT02354963|144363481|SUPERIORITY|||||||0.449|||||||Wilcoxon (Mann-Whitney)|||||||0.449
72425953|NCT02354963|144363482|SUPERIORITY|||||||0.021|||||||Wilcoxon (Mann-Whitney)|||||||0.021
72425954|NCT02354963|144363483|SUPERIORITY|||||||0.427|||||||Wilcoxon (Mann-Whitney)|||||||0.427
72425955|NCT02354963|144363484|SUPERIORITY|||||||0.496|||||||Wilcoxon (Mann-Whitney)|||||||0.496
72425956|NCT02354963|144363485|SUPERIORITY||Risk Ratio (RR)|0.71||||0.684|TWO_SIDED|95.0|0.13|3.68|||Chi-squared|||||3.68|0.13|0.684
72425957|NCT02354963|144363486|SUPERIORITY|||||||0.48|||||||Chi-squared|||||||0.480
72425958|NCT02354963|144363487|SUPERIORITY|||||||0.236|||||||Chi-squared|||||||0.236
72425959|NCT02354963|144363488|SUPERIORITY||Risk Ratio (RR)|0.71||||0.684|TWO_SIDED|95.0|0.13|3.68|||Chi-squared|||||3.68|0.13|0.684
72425960|NCT02354963|144363489|SUPERIORITY||Risk Ratio (RR)|0.36||||0.512|TWO_SIDED|95.0|0.04|3.05|||Chi-squared|||||3.05|0.04|0.512
72425961|NCT03125941|144363506|SUPERIORITY||Odds Ratio (OR)|1.0||||1|TWO_SIDED|95.0|0.49|2.05|||Chi-squared|||||2.05|0.49|1
72425962|NCT03125941|144363507|SUPERIORITY|||||||0.114|||||||Wilcoxon (Mann-Whitney)|||||||0.114
72425963|NCT03125941|144363508|SUPERIORITY|||||||0.294|||||||Wilcoxon (Mann-Whitney)|||||||0.294
72425964|NCT03125941|144363511|SUPERIORITY|||||||0.35|||||||Wilcoxon (Mann-Whitney)|||||||0.350
72425965|NCT03125941|144363512|SUPERIORITY|||||||0.217|||||||Wilcoxon (Mann-Whitney)|||||||0.217
72425966|NCT03125941|144363514|SUPERIORITY||||||>|0.193||||||a priori threshold, bonferroni corrected 0.0125|Wilcoxon (Mann-Whitney)|||||||>0.193
72425967|NCT03125941|144363515|SUPERIORITY||||||>|0.2|||||||Wilcoxon (Mann-Whitney)|||||||>0.2
72425968|NCT03125941|144363516|SUPERIORITY||||||>|0.136|||||||Chi-squared|||||||>0.136
72425969|NCT03125941|144363517|SUPERIORITY||||||>|0.003||||||A priori threshold for statistical significans was 0.00125 due to multiple comparisons|Chi-squared|||||||>0.003
72425970|NCT03125941|144363518|SUPERIORITY||Odds Ratio (OR)|3.53||||0.03|TWO_SIDED|95.0|1.07|11.6|||Chi-squared|||||11.6|1.07|0.030
72425971|NCT01370005|144363575|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.62|STANDARD_ERROR_OF_MEAN|0.05|<|0.0001|TWO_SIDED|95.0|-0.72|-0.52||Hierarchical testing, no adjustment of p-values.|ANCOVA|Model includes baseline HbA1c as lin. covariate and treatment, baseline renal function, region and baseline N of antihyperten. med. as fixed effects|Difference calculated as empa 10mg minus placebo|Hierarchical testing structure was: 1) Change from baseline to week 12 in HbA1c, empa 25mg vs placebo 2) Change from baseline to week 12 in mean 24h SBP, empa 25mg vs placebo 3) Change from baseline to week 12 in HbA1c, empa 10mg vs placebo 4) Change from baseline in mean 24h SBP, empa 10mg vs placebo 5) Change from baseline in mean 24h DBP, empa 25mg vs placebo 6) Change from baseline in mean 24h DBP empa 10mg vs placebo.||-0.52|-0.72|<0.0001
72425972|NCT01370005|144363575|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.65|STANDARD_ERROR_OF_MEAN|0.05|<|0.0001|TWO_SIDED|95.0|-0.75|-0.55||Hierarchical testing, no adjustment of p-values|ANCOVA|Model includes baseline HbA1c as lin. covariate and treatment, baseline renal function, region and baseline N of antihyperten. med. as fixed effects|Difference calculated as empa 25mg minus placebo|Hierarchical testing structure was: 1) Change from baseline to week 12 in HbA1c, empa 25mg vs placebo 2) Change from baseline to week 12 in mean 24h SBP, empa 25mg vs placebo 3) Change from baseline to week 12 in HbA1c, empa 10mg vs placebo 4) Change from baseline in mean 24h SBP, empa 10mg vs placebo 5) Change from baseline in mean 24h DBP, empa 25mg vs placebo 6) Change from baseline in mean 24h DBP empa 10mg vs placebo.||-0.55|-0.75|<0.0001
72425973|NCT01370005|144363576|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.44|STANDARD_ERROR_OF_MEAN|0.69|<|0.0001|TWO_SIDED|95.0|-4.78|-2.09||Hierarchical testing, no adjustment of p-values.|ANCOVA|Model incl. baseline (bl) HbA1c, bl mean 24h SBP as lin. covariates; treatment, bl renal function, region, bl N of antihyperten. med. as fixed effects|Difference calculated as empa 10mg minus placebo|Hierarchical testing structure was: 1) Change from baseline to week 12 in HbA1c, empa 25mg vs placebo 2) Change from baseline to week 12 in mean 24h SBP, empa 25mg vs placebo 3) Change from baseline to week 12 in HbA1c, empa 10mg vs placebo 4) Change from baseline in mean 24h SBP, empa 10mg vs placebo 5) Change from baseline in mean 24h DBP, empa 25mg vs placebo 6) Change from baseline in mean 24h DBP empa 10mg vs placebo.||-2.09|-4.78|<0.0001
72425974|NCT01370005|144363576|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.16|STANDARD_ERROR_OF_MEAN|0.68|<|0.0001|TWO_SIDED|95.0|-5.5|-2.83||Hierarchical testing, no adjustment of p-values.|ANCOVA|Model incl. baseline (bl) HbA1c, bl mean 24h SBP as lin. covariates; treatment, bl renal function, region, bl N of antihyperten. med. as fixed effects|Difference calculated as empa 25mg minus placebo|Hierarchical testing structure was: 1) Change from baseline to week 12 in HbA1c, empa 25mg vs placebo 2) Change from baseline to week 12 in mean 24h SBP, empa 25mg vs placebo 3) Change from baseline to week 12 in HbA1c, empa 10mg vs placebo 4) Change from baseline in mean 24h SBP, empa 10mg vs placebo 5) Change from baseline in mean 24h DBP, empa 25mg vs placebo 6) Change from baseline in mean 24h DBP empa 10mg vs placebo.||-2.83|-5.50|<0.0001
72425975|NCT01370005|144363577|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.36|STANDARD_ERROR_OF_MEAN|0.4||0.0008|TWO_SIDED|95.0|-2.15|-0.56||Hierarchical testing, no adjustment of p-values.|ANCOVA|Model incl. baseline (bl) HbA1c, bl mean 24h DBP as lin. covariates; treatment, bl renal function, region, bl N of antihyperten. med. as fixed effects|Difference calculated as empa 10mg minus placebo|Hierarchical testing structure was: 1) Change from baseline to week 12 in HbA1c, empa 25mg vs placebo 2) Change from baseline to week 12 in mean 24h SBP, empa 25mg vs placebo 3) Change from baseline to week 12 in HbA1c, empa 10mg vs placebo 4) Change from baseline in mean 24h SBP, empa 10mg vs placebo 5) Change from baseline in mean 24h DBP, empa 25mg vs placebo 6) Change from baseline in mean 24h DBP empa 10mg vs placebo.||-0.56|-2.15|0.0008
72425976|NCT01370005|144363577|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.72|STANDARD_ERROR_OF_MEAN|0.4|<|0.0001|TWO_SIDED|95.0|-2.51|-0.93||Hierarchical testing, no adjustment of p-values.|ANCOVA|Model incl. baseline (bl) HbA1c, bl mean 24h DBP as lin. covariates; treatment, bl renal function, region, bl N of antihyperten. med. as fixed effects|Difference calculated as empa 25mg minus placebo|Hierarchical testing structure was: 1) Change from baseline to week 12 in HbA1c, empa 25mg vs placebo 2) Change from baseline to week 12 in mean 24h SBP, empa 25mg vs placebo 3) Change from baseline to week 12 in HbA1c, empa 10mg vs placebo 4) Change from baseline in mean 24h SBP, empa 10mg vs placebo 5) Change from baseline in mean 24h DBP, empa 25mg vs placebo 6) Change from baseline in mean 24h DBP empa 10mg vs placebo.||-0.93|-2.51|<0.0001
72425977|NCT01370005|144363578|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.26|||<|0.0001|TWO_SIDED|95.0|3.51|11.18|||Regression, Logistic|Logistic regression model includes treatment, baseline renal function, region, baseline number of antihypertensive medications and baseline HbA1c||||11.18|3.51|<0.0001
72425978|NCT01370005|144363578|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.59|||<|0.0001|TWO_SIDED|95.0|3.7|11.75|||Regression, Logistic|Logistic regression model includes treatment, baseline renal function, region, baseline number of antihypertensive medications and baseline HbA1c||||11.75|3.70|<0.0001
72335373|NCT00834990|144193591|NON_INFERIORITY_OR_EQUIVALENCE|The pharmacokinetic parameters were evaluated statistically by an analysis of variance (ANOVA) appropriate for the experimental design of this study.|Ratio of the T/R geometric mean x 100|103.17||||||90.0|98.5|108.05|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||108.05|98.5|
72335374|NCT00791479|144193598|SUPERIORITY_OR_OTHER||||||<|0.001||||||A priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Test of log linear dose response with placebo.||||<0.001
72335375|NCT00791479|144193598|SUPERIORITY_OR_OTHER||||||<|0.001||||||A priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Test of log linear dose response without placebo.||||<0.001
72425979|NCT01370005|144363579|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-23.76|STANDARD_ERROR_OF_MEAN|2.63|<|0.0001|TWO_SIDED|95.0|-28.91|-18.6|||ANCOVA|Model includes treatment, baseline renal function, geographical region, baseline N of antihyperten. med., baseline HbA1c and baseline FPG|Difference calculated as empa 10mg minus placebo.|||-18.60|-28.91|<0.0001
72425980|NCT01370005|144363579|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-30.2|STANDARD_ERROR_OF_MEAN|2.61|<|0.0001|TWO_SIDED|95.0|-35.32|-25.08|||ANCOVA|Model includes treatment, baseline renal function, geographical region, baseline N of antihyperten. med., baseline HbA1c and baseline FPG|Difference calculated as empa 25mg minus placebo.|||-25.08|-35.32|<0.0001
72425981|NCT01370005|144363580|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.49|STANDARD_ERROR_OF_MEAN|0.18|<|0.0001|TWO_SIDED|95.0|-1.85|-1.13|||ANCOVA|Model includes treatment, baseline renal function, geographical region, baseline number of antihypertensive med., baseline HbA1c and baseline weight|Difference calculated as empa 10mg minus placebo.|||-1.13|-1.85|<0.0001
72425982|NCT01370005|144363580|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.98|STANDARD_ERROR_OF_MEAN|0.18|<|0.0001|TWO_SIDED|95.0|-2.33|-1.62|||ANCOVA|Model includes treatment, baseline renal function, geographical region, baseline number of antihypertensive med., baseline HbA1c and baseline weight|Difference calculated as empa 10mg minus placebo.|||-1.62|-2.33|<0.0001
72425983|NCT01370005|144363581|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.94|STANDARD_ERROR_OF_MEAN|0.73|<|0.0001|TWO_SIDED|95.0|-5.37|-2.52|||ANCOVA|Model includes treatment, baseline renal function, geographical region, N of antihypertensive medications, baseline HbA1c and baseline daytime SBP|Difference calculated as empa 10mg minus placebo.|||-2.52|-5.37|<0.0001
72425984|NCT01370005|144363581|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.78|STANDARD_ERROR_OF_MEAN|0.72|<|0.0001|TWO_SIDED|95.0|-6.2|-3.36|||ANCOVA|Model includes treatment, baseline renal function, geographical region, baseline N of antihyperten. med., baseline HbA1c and baseline daytime SBP|Difference calculated as empa 25mg minus placebo.|||-3.36|-6.20|<0.0001
72425985|NCT01370005|144363582|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.56|STANDARD_ERROR_OF_MEAN|0.44||0.0004|TWO_SIDED|95.0|-2.42|-0.69|||ANCOVA|Model includes treatment, baseline renal function, geographical region, baseline N of antihyperten. med., baseline HbA1c and baseline daytime DBP|Difference calculated as empa 10mg minus placebo.|||-0.69|-2.42|0.0004
72425986|NCT01370005|144363582|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.98|STANDARD_ERROR_OF_MEAN|0.44|<|0.0001|TWO_SIDED|95.0|-2.84|-1.12|||ANCOVA|Model includes treatment, baseline renal function, geographical region, baseline N of antihyperten. med., baseline HbA1c and baseline daytime DBP|Difference calculated as empa 25mg minus placebo.|||-1.12|-2.84|<0.0001
72335376|NCT00791479|144193598|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.37||||0.069||||||An adjustment for multiplicity was performed when comparing the individual doses to placebo using a Dunnett's test.|Mixed Models Analysis|||||||0.069
72335377|NCT00791479|144193598|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.89|||<|0.001||||||An adjustment for multiplicity was performed when comparing the individual doses to placebo using a Dunnett's test.|Mixed Models Analysis|||||||<0.001
72425987|NCT01370005|144363583|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.5|STANDARD_ERROR_OF_MEAN|0.81||0.0021|TWO_SIDED|95.0|-4.09|-0.91|||ANCOVA|Model includes treatment, baseline renal function, geographical region, baseline N of antihyperten. med., baseline HbA1c and baseline night-time SBP|Difference calculated as empa 10mg minus placebo.|||-0.91|-4.09|0.0021
72425988|NCT01370005|144363583|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.9|STANDARD_ERROR_OF_MEAN|0.81||0.0003|TWO_SIDED|95.0|-4.48|-1.32|||ANCOVA|Model includes treatment, baseline renal function, geographical region, baseline N of antihyperten. med., baseline HbA1c and baseline night-time SBP|Difference calculated as empa 25mg minus placebo.|||-1.32|-4.48|0.0003
72425989|NCT01370005|144363584|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.95|STANDARD_ERROR_OF_MEAN|0.5||0.0566|TWO_SIDED|95.0|-1.93|0.03|||ANCOVA|Model includes treatment, baseline renal function, geographical region, baseline N of antihyperten. med., baseline HbA1c and baseline night-time DBP|Difference calculated as empa 10mg minus placebo.|||0.03|-1.93|0.0566
72425990|NCT01370005|144363584|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.15|STANDARD_ERROR_OF_MEAN|0.5||0.0208|TWO_SIDED|95.0|-2.12|-0.18|||ANCOVA|Model includes treatment, baseline renal function, geographical region, baseline N of antihyperten. med., baseline HbA1c and baseline night-time DBP|Difference calculated as empa 25mg minus placebo.|||-0.18|-2.12|0.0208
72425991|NCT01370005|144363585|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.92|STANDARD_ERROR_OF_MEAN|0.99|<|0.0001|TWO_SIDED|95.0|-5.86|-1.98|||ANCOVA|Model includes treatment, baseline renal function, geographical region, baseline N of antihyperten. med., baseline HbA1c and baseline seated SBP|Difference calculated as empa 10mg minus placebo.|||-1.98|-5.86|<0.0001
72425992|NCT01370005|144363585|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.8|STANDARD_ERROR_OF_MEAN|0.98|<|0.0001|TWO_SIDED|95.0|-6.73|-2.87|||ANCOVA|Model includes treatment, baseline renal function, geographical region, baseline N of antihyperten. med., baseline HbA1c and baseline seated SBP|Difference calculated as empa 25mg minus placebo.|||-2.87|-6.73|<0.0001
72335378|NCT00791479|144193598|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.04|||<|0.001||||||An adjustment for multiplicity was performed when comparing the individual doses to placebo using a Dunnett's test.|Mixed Models Analysis|||||||<0.001
72335379|NCT00791479|144193598|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.04|||<|0.001||||||An adjustment for multiplicity was performed when comparing the individual doses to placebo using a Dunnett's test.|Mixed Models Analysis|||||||<0.001
72335380|NCT00791479|144193599|SUPERIORITY_OR_OTHER||||||<|0.001||||||Treatment comparison at Week 4. A priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Test of log linear dose response with placebo.||||<0.001
72335381|NCT00791479|144193599|SUPERIORITY_OR_OTHER|||||||0.023||||||Treatment comparison at Week 4. A priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Test of log linear dose response without placebo.||||0.023
72335382|NCT00791479|144193599|SUPERIORITY_OR_OTHER||||||<|0.001||||||Treatment comparison at Week 8. A priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Test of log linear dose response with placebo.||||<0.001
72335383|NCT00791479|144193599|SUPERIORITY_OR_OTHER||||||<|0.001||||||Treatment comparison at Week 8. A priori threshold for statistical significance was P\<0.05.|Mixed Models Analysis|||Test of log linear dose response without placebo.||||<0.001
72335384|NCT00791479|144193600|SUPERIORITY_OR_OTHER||||||<|0.001||||||A priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Test of log linear dose response with placebo.||||<0.001
72335385|NCT00791479|144193600|SUPERIORITY_OR_OTHER||||||<|0.001||||||A priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Test of log linear dose response without placebo.||||<0.001
72335386|NCT00791479|144193600|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.81||||0.456||||||An adjustment for multiplicity was performed when comparing the individual doses to placebo using a Dunnett's test.|Mixed Models Analysis|||||||0.456
72335387|NCT00791479|144193600|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-26.53|||<|0.001||||||An adjustment for multiplicity was performed when comparing the individual doses to placebo using a Dunnett's test.|Mixed Models Analysis|||||||<0.001
72335388|NCT00791479|144193600|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-29.96|||<|0.001||||||An adjustment for multiplicity was performed when comparing the individual doses to placebo using a Dunnett's test.|Mixed Models Analysis|||||||<0.001
72335389|NCT00791479|144193600|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-33.71|||<|0.001||||||An adjustment for multiplicity was performed when comparing the individual doses to placebo using a Dunnett's test.|Mixed Models Analysis|||||||<0.001
72335390|NCT00791479|144193601|SUPERIORITY_OR_OTHER||||||<|0.001||||||Treatment comparison of glycosylated hemoglobin (HbA1c) levels \<7.0%.|Cochran-Armitage trend test|The Cochran-Armitage trend test included the placebo arm.||||||<0.001
72335391|NCT00791479|144193601|SUPERIORITY_OR_OTHER||||||<|0.001||||||Treatment comparison of glycosylated hemoglobin (HbA1c) levels ≤6.5%.|Cochran-Armitage trend test|The Cochran-Armitage trend test included the placebo arm.||||||<0.001
72335392|NCT00791479|144193602|SUPERIORITY_OR_OTHER||||||<|0.001||||||A priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Test of log linear dose response with placebo.||||<0.001
72335393|NCT00791479|144193602|SUPERIORITY_OR_OTHER||||||<|0.001||||||A priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Test of log linear dose response without placebo.||||<0.001
72335394|NCT00791479|144193602|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.65||||0.378||||||An adjustment for multiplicity was performed when comparing the individual doses to placebo using a Dunnett's test.|Mixed Models Analysis|||||||0.378
72335395|NCT00791479|144193602|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-26.09|||<|0.001||||||An adjustment for multiplicity was performed when comparing the individual doses to placebo using a Dunnett's test.|Mixed Models Analysis|||||||<0.001
72335396|NCT00791479|144193602|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-36.34|||<|0.001||||||An adjustment for multiplicity was performed when comparing the individual doses to placebo using a Dunnett's test.|Mixed Models Analysis|||||||<0.001
72335397|NCT00791479|144193602|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-38.67|||<|0.001||||||An adjustment for multiplicity was performed when comparing the individual doses to placebo using a Dunnett's test.|Mixed Models Analysis|||||||<0.001
72335398|NCT00791479|144193603|SUPERIORITY_OR_OTHER||||||<|0.001||||||A priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Test of log linear dose response with placebo.||||<0.001
72335399|NCT00791479|144193603|SUPERIORITY_OR_OTHER|||||||0.036||||||A priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Test of log linear dose response without placebo.||||0.036
72335400|NCT00791479|144193604|SUPERIORITY_OR_OTHER|||||||0.45||||||A priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Test of log linear dose response with placebo.||||0.450
72335401|NCT00791479|144193604|SUPERIORITY_OR_OTHER|||||||0.329||||||A priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Test of log linear dose response without placebo.||||0.329
72335402|NCT00791479|144193612|SUPERIORITY_OR_OTHER|||||||0.969||||||A priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Test of log linear dose response with placebo.||||0.969
72335403|NCT00791479|144193612|SUPERIORITY_OR_OTHER|||||||0.009||||||A priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Test of log linear dose response without placebo.||||0.009
72335404|NCT00791479|144193612|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.19||||0.14||||||An adjustment for multiplicity was performed when comparing the individual doses to placebo using a Dunnett's test.|Mixed Models Analysis|||||||0.140
72335405|NCT00791479|144193612|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.04||||0.247||||||An adjustment for multiplicity was performed when comparing the individual doses to placebo using a Dunnett's test.|Mixed Models Analysis|||||||0.247
72335406|NCT00791479|144193612|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.27||||0.975||||||An adjustment for multiplicity was performed when comparing the individual doses to placebo using a Dunnett's test.|Mixed Models Analysis|||||||0.975
72335407|NCT00791479|144193612|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.11||||1||||||An adjustment for multiplicity was performed when comparing the individual doses to placebo using a Dunnett's test.|Mixed Models Analysis|||||||1.00
72335408|NCT01778049|144193615|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.32|STANDARD_ERROR_OF_MEAN|0.1||0.0013||95.0|-0.52|-0.13|||Mixed Model Repeated Measure (MMRM)|The unstructured covariance structure has been used to fit the mixed model.|Mean Difference (Final Values) is actually the adjusted mean difference calculated as lina5 (E10) minus Plc (E10) value.|Superiority of lina5 (E10) vs. Plc (E10): change in HbA1c using a restricted maximum likelihood (REML)- based mixed model repeated measures (MMRM) approach. The model includes baseline HbA1c as linear covariates \& baseline estimated glomerula filtration rate (eGFR), geographical region, treatment, visit, visit by treatment interaction as fixed effects.||-0.13|-0.52|0.0013
72335409|NCT01778049|144193615|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.47|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001||95.0|-0.66|-0.28|||MMRM|The unstructured covariance structure has been used to fit the mixed model.|Mean Difference (Final Values) is actually the adjusted mean difference value calculated as lina5 (E25) minus Plc (E25).|Superiority of lina5 (E25) vs. Plc (E25): change in HbA1c using a restricted maximum likelihood (REML)- based mixed model repeated measures (MMRM) approach. The model includes baseline HbA1c as linear covariates \& baseline eGFR, geographical region, treatment, visit, visit by treatment interaction as fixed effects.||-0.28|-0.66|<0.0001
72335410|NCT01778049|144193616|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.65|STANDARD_ERROR_OF_MEAN|0.25||0.0103||95.0|-1.15|-0.16|||MMRM|The unstructured covariance structure has been used to fit the mixed model.|Mean Difference (Final Values) is actually the adjusted mean difference value calculated as lina5 (E10) minus Plc (E10).|Superiority of lina5 (E10) vs. Plc (E10): change in FPG using a restricted maximum likelihood (REML)- based mixed model repeated measures (MMRM) approach. The model includes baseline HbA1c \& baseline eGFR as linear covariates, geographical region, treatment, visit, visit by treatment interaction as fixed effects.||-0.16|-1.15|0.0103
72335411|NCT01778049|144193616|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.44|STANDARD_ERROR_OF_MEAN|0.22||0.0452||95.0|-0.87|-0.01|||MMRM|The unstructured covariance structure has been used to fit the mixed model.|Mean Difference (Final Values) is actually the adjusted mean difference value calculated as lina5 (E25) minus Plc (E25).|Superiority of lina5 (E25) vs. Plc (E25): change in FPG using a restricted maximum likelihood (REML)- based mixed model repeated measures (MMRM) approach. The model includes baseline HbA1c \& baseline eGFR as linear covariates, geographical region, treatment, visit, visit by treatment interaction as fixed effects.||-0.01|-0.87|0.0452
72335412|NCT02379988|144193628|EQUIVALENCE|The wilcoxon paired signed rank test was used as the primary analysis because of the non-normal distributions|||||=|0.0063||||||P-value for Free breathing and Breath Holding Heart Mean|Wilcoxon (Mann-Whitney)|||||||=0.0063
72335413|NCT02379988|144193628|EQUIVALENCE|The wilcoxon paired signed rank test was used as the primary analysis because of the non-normal distributions.|||||=|0.011||||||P-value for Free breathing and Breath Holding Lung Mean|Wilcoxon (Mann-Whitney)|||||||=0 .0110
72335414|NCT02379988|144193628|EQUIVALENCE|The wilcoxon paired signed rank test was used as the primary analysis because of the non-normal distributions.|||||=|0.5098||||||P-value for Free breathing and Breath Holding LAD Mean|Wilcoxon (Mann-Whitney)|||||||=0.5098
72335415|NCT02379988|144193629|EQUIVALENCE|The wilcoxon paired signed rank test was used as the primary analysis because of the non-normal distributions|||||=|0.001||||||P-value for Heart Max Free breathing and Breath Hold|Wilcoxon (Mann-Whitney)|||||||=0.0010
72335416|NCT02379988|144193629|EQUIVALENCE|The wilcoxon paired signed rank test was used as the primary analysis because of the non-normal distributions.|||||=|0.011||||||P-value for Lung Max Free breathing and Breath Hold|Wilcoxon (Mann-Whitney)|||||||=0.0110
72335417|NCT02379988|144193630|EQUIVALENCE|Paired T-test|||||=|0.01||||||P-value for Large breast volume group|Paired T-test|||||||=0.01
72335418|NCT02379988|144193630|EQUIVALENCE|Paired T-test|||||=|0.1||||||P-value for Small breast volume group|Paired T-test|||||||=0.10
72425993|NCT01370005|144363586|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.93|STANDARD_ERROR_OF_MEAN|0.55||0.0005|TWO_SIDED|95.0|-3.01|-0.84|||ANCOVA|Model includes treatment, baseline renal function, geographical region, baseline N of antihyperten. med., baseline HbA1c and baseline seated DBP|Difference calculated as empa 10mg minus placebo.|||-0.84|-3.01|0.0005
72335419|NCT02379988|144193631|EQUIVALENCE|Wilcoxon test was used due to the non-normal distribution of the data|||||=|0.7776|||||||Wilcoxon (Mann-Whitney)|||||||=0.7776
72335420|NCT02089464|144193696|SUPERIORITY|||||||0.76|||||||Chi-squared|||||||0.76
72335421|NCT02089464|144193697|SUPERIORITY|||||||0.8|||||||t-test, 2 sided|||||||0.80
72335422|NCT02089464|144193698|SUPERIORITY|||||||0.55|||||||Wilcoxon (Mann-Whitney)|||||||0.55
72335423|NCT02089464|144193699|SUPERIORITY|||||||0.14|||||||t-test, 2 sided|||||||0.14
72335424|NCT02089464|144193700|SUPERIORITY|||||||0.14|||||||t-test, 2 sided|||||||0.14
72335425|NCT02089464|144193702|SUPERIORITY|||||||0.95|||||||t-test, 2 sided|||||||0.95
72335426|NCT02089464|144193703|SUPERIORITY|||||||0.96|||||||t-test, 2 sided|||||||0.96
72335427|NCT02089464|144193704|SUPERIORITY|||||||0.63|||||||Chi-squared|||||||0.63
72335428|NCT00934947|144193710|SUPERIORITY|||||||0.36|||||||t-test, 2 sided|||||||.36
72335429|NCT00934947|144193711|SUPERIORITY|||||||0.32|||||||t-test, 2 sided|||||||.32
72335430|NCT00934947|144193712|SUPERIORITY|||||||0.48|||||||t-test, 2 sided|||||||.48
72335431|NCT01907321|144193713|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|32.78|STANDARD_DEVIATION|14.98||0.001|TWO_SIDED||||||repeated measures ANOVA|||||||.001
72335432|NCT01907321|144193714|SUPERIORITY_OR_OTHER|||||||0.519|||||||ANOVA|||||||.519
72335433|NCT04049266|144193721|NON_INFERIORITY|The maximum clinically acceptable true difference between KSI-301 and aflibercept participants to be considered non-inferior is 4 ETDRS letters, i.e. the non-inferiority margin (NI) is 4 letters.|Adjusted mean difference|-6.0|STANDARD_ERROR_OF_MEAN|1.01|>|0.9999|TWO_SIDED|95.03|-8.0|-4.0|||Mixed Models Analysis|MMRM model with treatment, visit, treatment by visit interaction, categories for baseline BCVA, BCVA-low luminance VA baseline, geographical location.||||-4|-8|> 0.9999
72335434|NCT01703208|144193729|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.0|||||TWO_SIDED|95.0|0.77|1.29|||||Based on the proportional hazards model that includes treatment as an explanatory factor.|||1.29|0.77|
72335435|NCT01703208|144193730|SUPERIORITY_OR_OTHER||Difference in the least squares means|-0.43|||||TWO_SIDED|95.0|-0.48|-0.37||||||||-0.37|-0.48|
72335436|NCT01703208|144193731|SUPERIORITY_OR_OTHER||Difference in the LS Means vs Placebo|-0.39|||<|0.001|TWO_SIDED|95.0|-0.5|-0.27|||Longitudinal data analysis|Longitudinal data analysis model including terms for treatment, time and the interaction of time by treatment.||||-0.27|-0.50|<0.001
72335437|NCT01703208|144193732|SUPERIORITY_OR_OTHER||Difference in Percent vs. Placebo|-1.1|||||TWO_SIDED|95.0|-7.2|4.9|||||Based on Miettinen \& Nurminen method. The 95% CI was computed only for those endpoints with at least 4 participants having events in one or more treatment groups.|||4.9|-7.2|
72335438|NCT01703208|144193733|SUPERIORITY_OR_OTHER||Difference in Percentage vs. Placebo|0.3|||||TWO_SIDED|95.0|-1.0|1.7|||||Based on Miettinen \& Nurminen method. The 95% CI was computed only for those endpoints with at least 4 participants having events in one or more treatment groups.|||1.7|-1.0|
72335439|NCT01703208|144193735|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.06|||||TWO_SIDED|95.0|0.66|1.68|||||Based on the proportional hazards model that includes treatment as an explanatory factor.|||1.68|0.66|
72335440|NCT01703208|144193737|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.87|||||TWO_SIDED|95.0|0.6|1.26|||||Based on the proportional hazards model that includes treatment as an explanatory factor.|||1.26|0.60|
72335441|NCT01703208|144193739|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.94|||||TWO_SIDED|95.0|0.58|1.52|||||Based on the proportional hazards model that includes treatment as an explanatory factor.|||1.52|0.58|
72335442|NCT01703208|144193741|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.28|||||TWO_SIDED|95.0|0.88|1.85|||||Based on the proportional hazards model that includes treatment as an explanatory factor.|||1.85|0.88|
72335443|NCT01703208|144193742|SUPERIORITY_OR_OTHER||Difference in the Least Squares Means|-0.3|||||TWO_SIDED|95.0|-0.46|-0.14|||||Longitudinal Data Analysis (LDA) model including terms for treatment, time, and the interaction of time by treatment.|||-0.14|-0.46|
72335444|NCT01703208|144193748|SUPERIORITY_OR_OTHER||Difference in the least squares means|-3.1||||0.421|TWO_SIDED|95.0|-10.8|4.5|||Longitudinal constrained data analysis||Based on a LDA model including terms for treatment, time and the interaction of time by treatment.|||4.5|-10.8|0.421
72335445|NCT01703208|144193749|SUPERIORITY_OR_OTHER||Between group rate difference|11.9|||<|0.001|TWO_SIDED|95.0|6.9|16.8||Estimated using standard multiple imputation techniques.|Miettinen & Nurminen method|||||16.8|6.9|<0.001
72425994|NCT01370005|144363586|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.89|STANDARD_ERROR_OF_MEAN|0.55||0.0006|TWO_SIDED|95.0|-2.97|-0.82|||ANCOVA|Model includes treatment, baseline renal function, geographical region, baseline N of antihyperten. med., baseline HbA1c and baseline seated DBP|Difference calculated as empa 25mg minus placebo.|||-0.82|-2.97|0.0006
72425995|NCT01370005|144363587|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.49||||0.0021|TWO_SIDED|95.0|1.39|4.45|||Regression, Logistic|Logistic regression model includes treatment, baseline renal function, region, baseline number of antihypertensive medications and baseline HbA1c||||4.45|1.39|0.0021
72425996|NCT01370005|144363587|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.2||||0.0088|TWO_SIDED|95.0|1.22|3.96|||Regression, Logistic|Logistic regression model includes treatment, baseline renal function, region, baseline number of antihypertensive medications and baseline HbA1c||||3.96|1.22|0.0088
72425997|NCT01871558|144363610|SUPERIORITY_OR_OTHER|||||||0.139|||||||Chi-squared|||||||0.139
72425998|NCT02041923|144363619|EQUIVALENCE|A t-test was conducted to evaluate equivalency.|Mean Difference (Net)|46.3|||<|0.05|TWO_SIDED||||||t-test, 2 sided|||||||<0.05
72425999|NCT00874432|144363622|SUPERIORITY|||||||0.685|||||||t-test, 2 sided|||p-value for CBPWV between CKD and Control groups||||0.685
72426000|NCT00874432|144363622|SUPERIORITY|||||||0.739|||||||t-test, 2 sided|||p-value for CRPWV between CKD and Control groups||||0.739
72426001|NCT00874432|144363622|SUPERIORITY|||||||0.471|||||||t-test, 2 sided|||p-value for CFPWV between CKD and Control groups||||0.471
72335446|NCT01703208|144193751|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.6|||||TWO_SIDED|95.0|0.35|1.05|||||Based on the proportional hazards model that includes treatment as an explanatory factor.|||1.05|0.35|
72426002|NCT00874432|144363623|SUPERIORITY|||||||0.685|||||||t-test, 2 sided|||This p-value compares the baseline CBPWV measures for the CKD vs Controls group||||0.685
72426003|NCT00874432|144363623|SUPERIORITY|||||||0.869|||||||t-test, 2 sided|||This p-value compares the 12 month CBPWV measures for the CKD vs Controls group||||0.869
72426004|NCT00874432|144363623|SUPERIORITY|||||||0.709|||||||t-test, 2 sided|||This p-value compares the baseline CRPWV measures for the CKD vs Controls group||||0.709
72426005|NCT00874432|144363623|SUPERIORITY|||||||0.34|||||||t-test, 2 sided|||This p-value compares the 12 month CBPWV measures for the CKD vs Controls group||||0.340
72426006|NCT00874432|144363623|SUPERIORITY|||||||0.73|||||||t-test, 2 sided|||This p-value compares the baseline CFPWV measures for the CKD vs Controls group||||0.730
72426007|NCT00874432|144363623|SUPERIORITY|||||||0.204|||||||t-test, 2 sided|||This p-value compares the 12 month CFPWV measures for the CKD vs Controls group||||0.204
72426008|NCT00874432|144363623|SUPERIORITY|||||||0.963|||||||t-test, 2 sided|||This compares the 12 month CBPWV measure of ACE-I CKD and Control groups||||0.963
72426009|NCT00874432|144363623|SUPERIORITY|||||||0.991|||||||t-test, 2 sided|||This compares the 12 month CRPWV measure of ACE-I CKD and Control groups||||0.991
72426010|NCT00874432|144363623|SUPERIORITY|||||||0.176|||||||t-test, 2 sided|||This compares the 12 month CFPWV measure of ACE-I CKD and Control groups||||0.176
72426011|NCT00874432|144363623|SUPERIORITY|||||||0.402|||||||t-test, 2 sided|||This compares the baseline and 12 month CBPWV measure of the ACE-I CKD||||0.402
72426012|NCT00874432|144363623|SUPERIORITY|||||||0.586|||||||t-test, 2 sided|||This compares the baseline and 12 month CRPWV measure of the ACE-I CKD||||0.586
72426013|NCT00874432|144363623|SUPERIORITY|||||||0.455|||||||t-test, 2 sided|||This compares the baseline and 12 month CFPWV measure of the ACE-I CKD||||0.455
72426014|NCT00874432|144363623|SUPERIORITY|||||||0.418|||||||t-test, 2 sided|||This compares the baseline and 12 month CBPWV measure of the ACE-I Control Group||||0.418
72426015|NCT00874432|144363623|SUPERIORITY|||||||0.091|||||||t-test, 2 sided|||This compares the baseline and 12 month CRPWV measure of the ACE-I Control Group||||0.091
72426016|NCT00874432|144363623|SUPERIORITY|||||||0.034|||||||t-test, 2 sided|||This compares the baseline and 12 month CFPWV measure of the ACE-I Control Group||||0.034
72426017|NCT00874432|144363623|SUPERIORITY|||||||0.921|||||||t-test, 2 sided|||This compares the 12 month CBPWV measure of the CKD and Control groups||||0.921
72426018|NCT00874432|144363623|SUPERIORITY|||||||0.887|||||||t-test, 2 sided|||This compares the 12 month CRPWV measure of the CKD and Control groups||||0.887
72426019|NCT00874432|144363623|SUPERIORITY|||||||0.759|||||||t-test, 2 sided|||This compares the 12 month CFPWV measure of the CKD and Control groups||||0.759
72426020|NCT00874432|144363623|SUPERIORITY|||||||0.851|||||||t-test, 2 sided|||This compares the baseline and 12 month CBPWV measure of the Control groups||||0.851
72426021|NCT00874432|144363623|SUPERIORITY|||||||0.733|||||||t-test, 2 sided|||This compares the baseline and 12 month CRPWV measure of the Control groups||||0.733
72426022|NCT00874432|144363623|SUPERIORITY|||||||0.902|||||||t-test, 2 sided|||This compares the baseline and 12 month CFPWV measure of the Control groups||||0.902
72426023|NCT00874432|144363623|SUPERIORITY|||||||0.414|||||||t-test, 2 sided|||This compares the 12 month CBPWV measure between the CKD ACE-I and CKD Control groups.||||0.414
72426024|NCT00874432|144363623|SUPERIORITY|||||||0.942|||||||t-test, 2 sided|||This compares the 12 month CRPWV measure between the CKD ACE-I and CKD Control groups.||||0.942
72426025|NCT00874432|144363623|SUPERIORITY|||||||0.99|||||||t-test, 2 sided|||This compares the 12 month CFPWV measure between the CKD ACE-I and CKD Control groups.||||0.990
72426026|NCT00874432|144363623|SUPERIORITY|||||||0.273|||||||t-test, 2 sided|||This compares the 12 month CBPWV measure between the ACE-I Control and CKD Control groups.||||0.273
72426027|NCT00874432|144363623|SUPERIORITY|||||||0.516|||||||t-test, 2 sided|||This compares the 12 month CRPWV measure between the ACE-I Control and CKD Control groups.||||0.516
72335447|NCT00350272|144193784|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|-13.5|||||TWO_SIDED|95.0|-35.2|8.2||||||The difference in proportions between the group of participants who received lamivudine 300 mg/day (in combination with efavirenz and tenofovir) over 12 weeks and the group of participants who received elvucitabine 10 mg/day (in combination with efavirenz and tenofovir) over 12 weeks along with corresponding 2-sided 95% confidence interval for risk difference using asymptotic normal theory.||8.2|-35.2|
72335448|NCT03955250|144193798|SUPERIORITY||||||>|0.05|||||||t-test, 2 sided|||||||>0.05
72335449|NCT03955250|144193799|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|time||||||<0.05
72335450|NCT03955250|144193799|SUPERIORITY||||||>|0.05|||||||t-test, 2 sided|condition||||||>0.05
72335451|NCT03955250|144193800|SUPERIORITY||||||>|0.05|||||||t-test, 2 sided|time||||||>0.05
72335452|NCT03955250|144193800|SUPERIORITY||||||>|0.05|||||||t-test, 2 sided|condition||||||>0.05
72335453|NCT03955250|144193801|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|time||||||<0.05
72335454|NCT03955250|144193801|SUPERIORITY||||||>|0.05|||||||t-test, 2 sided|condition||||||>0.05
72426028|NCT00874432|144363623|SUPERIORITY|||||||0.102|||||||t-test, 2 sided|||This compares the 12 month CFPWV measure between the ACE-I Control and CKD Control groups.||||0.102
72426029|NCT01158378|144363644|NON_INFERIORITY_OR_EQUIVALENCE|non-inferiority margin of 10%||||||0.0049|||||||one-sided z-test|||||||0.0049
72426030|NCT01158378|144363645|NON_INFERIORITY_OR_EQUIVALENCE|non-inferiority margin of 10%|||||<|0.0001|||||||one-sided z-test|||||||<0.0001
72426031|NCT01158378|144363645|SUPERIORITY_OR_OTHER|||||||0.0297|||||||one-sided z-test|||Superiority Test||||0.0297
72426032|NCT01158378|144363646|NON_INFERIORITY_OR_EQUIVALENCE|non-inferiority margin of 10%|||||<|0.0001|||||||one-sided z-test|||||||<0.0001
72426033|NCT01158378|144363646|SUPERIORITY_OR_OTHER|||||||0.0561|||||||one-sided z-test|||Superiority Test||||0.0561
72426034|NCT03017235|144363648|NON_INFERIORITY|The NI margin for the difference between treatments (NaP/MC Oral Solution minus PREPOPIK) was pre-specified at -8% (absolute). If NI was demonstrated for both the primary efficacy endpoint and the secondary efficacy endpoint for the right colon, and if the lower bound of the CI was above 0%, then superiority was declared for the primary endpoint. Thus, the pre-specified superiority analysis was conducted at a one-sided significance level of 2.5%.|Difference in percentage|6.3||||0.0067|TWO_SIDED|95.0|1.8|10.9||The above p-value was calculated for superiority and was based on the stratified percentage difference test, where the stratification weight is based on Cochran-Mantel-Haenszel-weight.|Weighted Percentage Difference|CIs (treatment difference) were calculated using stratified (by site) percentage difference where, weights= Cochran-Mantel-Haenszel weights for site||Difference in the percentage of subjects on NaP/MC or PREPOPIK (NaP/MC - PREPOPIK)|Lower limit of 95% CI \> 0% for the primary efficacy endpoint combined with outcome of secondary efficacy endpoint for the right colon allowed for superiority analysis.|10.9|1.8|0.0067
72426035|NCT03017235|144363649|NON_INFERIORITY|If the lower limit of the 95% CI was greater than the margin (-8%), the null hypothesis was rejected and NaP/MC Oral Solution was claimed as non-inferior to PREPOPIK with respect to right colon cleansing in preparation for colonoscopy.|Difference in percentage|4.6||||0.0099|TWO_SIDED|95.0|1.1|8.0||The p-value was calculated for superiority and was based on the stratified percentage difference test, where the stratification weight is based on Cochran-Mantel-Haenszel-weight.|Weighted Percentage Difference|CIs (treatment difference) were calculated using stratified (by site) percentage difference where, weights= Cochran-Mantel-Haenszel weights for site||Difference in the percentage of subjects on NaP/MC or PREPOPIK (NaP/MC - PREPOPIK)||8.0|1.1|0.0099
72426036|NCT03017235|144363650|NON_INFERIORITY|If the lower limit of the 95% CI was greater than the margin (-8%), the null hypothesis was rejected and NaP/MC Oral Solution was claimed as non-inferior to PREPOPIK with respect to right colon cleansing in preparation for colonoscopy.|Difference in percentage|1.9||||0.1781|TWO_SIDED|95.0|-0.9|4.7||The above p-value was tested for superiority and was based on the stratified percentage difference test, where the stratification weight is based on Cochran Mantel Haenszel weight.|Weighted Percentage Difference|CIs (treatment difference) were calculated using stratified (by site) percentage difference where, weights= Cochran-Mantel-Haenszel weights for site||Difference in percentage of subjects on NaP/MC Oral Solution or PREPOPIK® (NaP/MC - PREPOPIK)||4.7|-0.9|0.1781
72335455|NCT00433160|144193812|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Percent Change to Last Measurement Point. No adjustments for multiplicity was performed.|t-test, 2 sided|||Null hypothesis: there is no difference in the percent change in bone mineral density at lumbar spine (L2-L4) after 52-week treatment between the two treatment groups.||||<0.001
72426037|NCT03017235|144363651|NON_INFERIORITY|If the lower limit of the 95% CI was greater than the margin (-8%), the null hypothesis was rejected and NaP/MC Oral Solution was claimed as non-inferior to PREPOPIK with respect to colon cleansing in preparation for colonoscopy.|Difference in percentage|3.5||||0.0391|TWO_SIDED|95.0|0.2|6.7||The above p-value was for superiority and was based on the stratified percentage difference, where the stratification weight is based on Cochran-Mantel-Haenszel weight.|Weighted Percentage Difference|CIs (treatment difference) were calculated using stratified (by site) percentage difference where, weights= Cochran-Mantel-Haenszel weights for site||Difference in percentage of subjects on NaP/MC Oral Solution or PREPOPIK® (NaP/MC-PREPOPIK®)||6.7|0.2|0.0391
72335456|NCT00433160|144193816|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Percent Change to Week 4. No adjustment for multiplicity was performed.|Wilcoxon's Rank Sum Test|||Null hypothesis: there is no difference in the percent change in PINP after 4-week treatment between the two treatment groups.||||<0.001
72335457|NCT00433160|144193816|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Percent Change to Week 12. No adjustment for multiplicity was performed.|Wilcoxon's Rank Sum Test|||Null hypothesis: there is no difference in the percent change in PINP after 12-week treatment between the two treatment groups.||||<0.001
72335458|NCT00433160|144193816|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Percent Change to Week 24. No adjustment for multiplicity was performed.|Wilcoxon's Rank Sum Test|||Null hypothesis: there is no difference in the percent change in PINP after 24-week treatment between the two treatment groups.||||<0.001
72335459|NCT00433160|144193816|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Percent Change to Week 52. No adjustment for multiplicity was performed.|Wilcoxon's Rank Sum Test|||Null hypothesis: there is no difference in the percent change in PINP after 52-week treatment between the two treatment groups.||||<0.001
72335460|NCT00433160|144193816|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Percent Change to Last Measurement. No adjustment for multiplicity was performed.|Wilcoxon's Rank Sum Test|||Null hypothesis: there is no difference in the percent change in PINP from baseline to the last measurement point between the two treatment groups.||||<0.001
72426038|NCT00649389|144363705|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||All treatment comparisons were calculated as OM40/AML10/HCTZ25 minus the respective dual combination treatment group. Least-squares mean differences, SEs, and 2-sided p-values were obtained from an ANCOVA model with baseline blood pressure as a covariate, and fixed effects of treatment, age group, race group, and diabetic status.||||<0.0001
72335461|NCT00433160|144193817|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Percent Change to Week 4. No adjustment for multiplicity was performed.|Wilcoxon's Rank Sum Test|||Null hypothesis: there is no difference in the percent change in BAP after 4-week treatment between the two treatment groups.||||<0.001
72426039|NCT00649389|144363705|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||All treatment comparisons were calculated as OM40/AML10/HCTZ25 minus the respective dual combination treatment group. Least-squares mean differences, SEs, and 2-sided p-values were obtained from an ANCOVA model with baseline blood pressure as a covariate, and fixed effects of treatment, age group, race group, and diabetic status.||||<0.0001
72426040|NCT00649389|144363705|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||All treatment comparisons were calculated as OM40/AML10/HCTZ25 minus the respective dual combination treatment group. Least-squares mean differences, SEs, and 2-sided p-values were obtained from an ANCOVA model with baseline blood pressure as a covariate, and fixed effects of treatment, age group, race group, and diabetic status.||||<0.0001
72426041|NCT00649389|144363706|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Cochran-Mantel-Haenszel|||Each p-value was obtained from individual Cochran-Mantel-Haenszel tests stratified by age group, race group, and diabetic status comparing the triple combination therapy to each dual combination.||||<0.0001
72426042|NCT00649389|144363706|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Cochran-Mantel-Haenszel|||Each p-value was obtained from individual Cochran-Mantel-Haenszel tests stratified by age group, race group, and diabetic status comparing the triple combination therapy to each dual combination.||||<0.0001
72426043|NCT00649389|144363706|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Cochran-Mantel-Haenszel|||Each p-value was obtained from individual Cochran-Mantel-Haenszel tests stratified by age group, race group, and diabetic status comparing the triple combination therapy to each dual combination.||||<0.0001
72426044|NCT00649389|144363707|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||Diastolic blood pressure: All treatment comparisons were calculated as OM40/AML10/HCTZ25 minus the respective dual combination treatment group. Least-squares mean differences, SEs, and 2-sided p-values were obtained from an ANCOVA model with baseline blood pressure as a covariate, and fixed effects of treatment, age group, race group, and diabetic status.||||<0.0001
72426045|NCT00649389|144363707|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||Diastolic blood pressure: All treatment comparisons were calculated as OM40/AML10/HCTZ25 minus the respective dual combination treatment group. Least-squares mean differences, SEs, and 2-sided p-values were obtained from an ANCOVA model with baseline blood pressure as a covariate, and fixed effects of treatment, age group, race group, and diabetic status.||||<0.0001
72426046|NCT00649389|144363707|SUPERIORITY_OR_OTHER|||||||0.0001||95.0|||||ANCOVA|||Diastolic blood pressure: All treatment comparisons were calculated as OM40/AML10/HCTZ25 minus the respective dual combination treatment group. Least-squares mean differences, SEs, and 2-sided p-values were obtained from an ANCOVA model with baseline blood pressure as a covariate, and fixed effects of treatment, age group, race group, and diabetic status.||||0.0001
72426047|NCT00649389|144363707|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||Systolic blood pressure: All treatment comparisons were calculated as OM40/AML10/HCTZ25 minus the respective dual combination treatment group. Least-squares mean differences, SEs, and 2-sided p-values were obtained from an ANCOVA model with baseline blood pressure as a covariate, and fixed effects of treatment, age group, race group, and diabetic status.||||<0.0001
72426048|NCT00649389|144363707|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||Systolic blood pressure: All treatment comparisons were calculated as OM40/AML10/HCTZ25 minus the respective dual combination treatment group. Least-squares mean differences, SEs, and 2-sided p-values were obtained from an ANCOVA model with baseline blood pressure as a covariate, and fixed effects of treatment, age group, race group, and diabetic status.||||<0.0001
72426049|NCT00649389|144363707|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||Systolic blood pressure: All treatment comparisons were calculated as OM40/AML10/HCTZ25 minus the respective dual combination treatment group. Least-squares mean differences, SEs, and 2-sided p-values were obtained from an ANCOVA model with baseline blood pressure as a covariate, and fixed effects of treatment, age group, race group, and diabetic status.||||<0.0001
72426050|NCT00649389|144363708|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||All treatment comparisons were calculated as OM40/AML10/HCTZ25 minus the respective dual combination treatment group. Least-squares mean differences, SEs, and 2-sided p-values were obtained from an ANCOVA model with baseline blood pressure as a covariate, and fixed effects of treatment, age group, race group, and diabetic status.||||<0.0001
72426051|NCT00649389|144363708|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||All treatment comparisons were calculated as OM40/AML10/HCTZ25 minus the respective dual combination treatment group. Least-squares mean differences, SEs, and 2-sided p-values were obtained from an ANCOVA model with baseline blood pressure as a covariate, and fixed effects of treatment, age group, race group, and diabetic status.||||<0.0001
72426052|NCT00649389|144363708|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||All treatment comparisons were calculated as OM40/AML10/HCTZ25 minus the respective dual combination treatment group. Least-squares mean differences, SEs, and 2-sided p-values were obtained from an ANCOVA model with baseline blood pressure as a covariate, and fixed effects of treatment, age group, race group, and diabetic status.||||<0.0001
72426053|NCT02444988|144363713|SUPERIORITY||Odds Ratio (OR)|0.87|||<|0.05|TWO_SIDED|95.0|0.77|0.99|||Regression, Logistic|||||0.99|0.77|<0.05
72426054|NCT02444988|144363714|SUPERIORITY||Odds Ratio (OR)|0.84|||<|0.05|TWO_SIDED|95.0|0.73|0.97|||Regression, Logistic|||||0.97|0.73|<0.05
72426055|NCT02105636|144363728|SUPERIORITY||Hazard Ratio (HR)|0.7||||0.0101|TWO_SIDED|95.0|0.53|0.92||Log-rank Test stratified by prior treatment with cetuximab (yes, no) as entered into the Interactive Voice Response System (IVRS). For OS the boundary for statistical significance requires the p-value to be less than 0.0227.|Log Rank||Hazard ratio (HR) and the corresponding Confidence Interval (CI) were estimated in a stratified Cox proportional hazards model for distribution of OS in each randomized arm.|Stratified Cox proportional hazard model. HR = Nivolumab over investigator's choice therapy (Cetuximab, Methotrexate, or Docetaxel)||0.92|0.53|0.0101
72426056|NCT02105636|144363729|SUPERIORITY||Hazard Ratio (HR)|0.86|||||TWO_SIDED|95.0|0.68|1.1|||||Number of responders (CR +PR) over number of participants|||1.10|0.68|
72426057|NCT02105636|144363730|SUPERIORITY||Difference in ORR|7.6|||||TWO_SIDED|95.0|1.5|13.6|||||Stratum adjusted difference in response rates (Nivolumab - Investigators Choice) based on the Cochran-Mantel-Haenszel method of weighting.|||13.6|1.5|
72426058|NCT02105636|144363730|SUPERIORITY||CMH Estimate of Common Odds Ratio|2.49|||||TWO_SIDED|95.0|1.07|5.82|||||Stratified by Prior Cetuximab (yes, no) as recorded in the IVRS. Stratum adjusted odds ratio (Nivolumab - Investigators Choice) using Mantel-Haenszel Method.|||5.82|1.07|
72426059|NCT02105636|144363731|SUPERIORITY||Hazard Ratio (HR)|0.68|||||TWO_SIDED|95.0|0.54|0.85|||||Stratified Cox proportional hazards model. Hazard ratio of nivolumab to investigator's choice therapy.|||0.85|0.54|
72426060|NCT00312858|144363764|NON_INFERIORITY_OR_EQUIVALENCE|Similarity (non-inferiority) based on lower bound of the 2-sided 95% CI on the risk difference of seroresponse rates excluding a decrease of 10 percentage points or more (lower bound \>-10.0).|Risk Difference (RD)|0.7|||<|0.001||95.0|-1.4|3.8||Similarity (non-inferiority) indicated that the risk difference was statistically significantly greater than the pre-specified clinically relevant difference of -10 percentage points at the 1-sided α=0.025 level.|Miettinen and Nurminen|For testing the non-inferiority of 2 proportions. Stratified by investigator.|Difference in estimated response rates of Arm 1 - Arm 2.|Comparison of the difference (percentage points) in estimated response rates of Arm 1 - Arm 2.||3.8|-1.4|<0.001
72335462|NCT00433160|144193817|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Percent Change to Week 12. No adjustment for multiplicity was performed.|Wilcoxon's Rank Sum Test|||Null hypothesis: there is no difference in the percent change in BAP after 12-week treatment between the two treatment groups.||||<0.001
72426061|NCT00312858|144363765|NON_INFERIORITY_OR_EQUIVALENCE|Similarity (non-inferiority) based on lower bound of the 2-sided 95% CI on the risk difference seroresponse rates excluding a decrease of 10 percentage points or more (lower bound \>-10.0).|Risk Difference (RD)|-5.1||||0.013||95.0|-9.3|-1.4||Similarity (non-inferiority) indicated that the risk difference was statistically significantly greater than the pre-specified clinically relevant difference of -10 percentage points at the 1-sided multiplicity-adjusted α=0.025 level.|Miettinen and Nurminen|For testing the non-inferiority of 2 proportions. Stratified by investigator.|Difference in estimated response rates of Arm 1 - Arm 2.|Comparison of the difference (percentage points) in estimated response rates of Arm 1 - Arm 2 for participants with initial serostatus \<1.25 gpELISA units/mL||-1.4|-9.3|0.013
72426062|NCT00312858|144363766|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority criterion is met if the lower bound of the 95% confidence interval of the response ratio is \>0.5, excluding a decrease of 2-fold or more|Response ratio (Arm 1 / Arm 2)|1.1|||<|0.001|TWO_SIDED|95.0|0.9|1.3|||ANCOVA||Response ratio is based on statistical models adjusting the GMT for combined study center and prevaccination titer|Serotype 4||1.3|0.9|<0.001
72426063|NCT00312858|144363766|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority criterion is met if the lower bound of the 95% confidence interval of the response ratio is \>0.5, excluding a decrease of 2-fold or more|Response ratio (Arm 1 / Arm 2)|1.0|||<|0.001|TWO_SIDED|95.0|0.8|1.2|||ANCOVA||Response ratio is based on statistical models adjusting the GMT for combined study center and prevaccination titer|Serotype 6B||1.2|0.8|<0.001
72426064|NCT00312858|144363766|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority criterion is met if the lower bound of the 95% confidence interval of the response ratio is \>0.5, excluding a decrease of 2-fold or more|Response ratio (Arm 1 / Arm 2)|0.9|||<|0.001|TWO_SIDED|95.0|0.8|1.0|||ANCOVA||Response ratio is based on statistical models adjusting the GMT for combined study center and prevaccination titer|Serotype 9V||1.0|0.8|<0.001
72426065|NCT00312858|144363766|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority criterion is met if the lower bound of the 95% confidence interval of the response ratio is \>0.5, excluding a decrease of 2-fold or more|Response ratio (Arm 1 / Arm 2)|1.0|||<|0.001|TWO_SIDED|95.0|0.9|1.2|||ANCOVA||Response ratio is based on statistical models adjusting the GMT for combined study center and prevaccination titer|Serotype 14||1.2|0.9|<0.001
72426066|NCT00312858|144363766|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority criterion is met if the lower bound of the 95% confidence interval of the response ratio is \>0.5, excluding a decrease of 2-fold or more|Response ratio (Arm 1 / Arm 2)|1.1|||<|0.001|TWO_SIDED|95.0|0.9|1.3|||ANCOVA||Response ratio is based on statistical models adjusting the GMT for combined study center and prevaccination titer|Serotype 18C||1.3|0.9|<0.001
72426067|NCT00312858|144363766|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority criterion is met if the lower bound of the 95% confidence interval of the response ratio is \>0.5, excluding a decrease of 2-fold or more|Response ratio (Arm 1 / Arm 2)|1.1|||<|0.001|TWO_SIDED|95.0|0.9|1.2|||ANCOVA||Response ratio is based on statistical models adjusting the GMT for combined study center and prevaccination titer|Serotype 19F||1.2|0.9|<0.001
72426068|NCT00312858|144363766|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority criterion is met if the lower bound of the 95% confidence interval of the response ratio is \>0.5, excluding a decrease of 2-fold or more|Response ratio (Arm 1 / Arm 2)|1.1|||<|0.001|TWO_SIDED|95.0|1.0|1.3|||ANCOVA||Response ratio is based on statistical models adjusting the GMT for combined study center and prevaccination titer|Serotype 23F||1.3|1.0|<0.001
72426069|NCT01863043|144363798|SUPERIORITY|||||||0.27|||||||Mixed Models Analysis|||||||0.27
72426070|NCT01863043|144363799|SUPERIORITY|||||||0.12|||||||Mixed Models Analysis|||||||0.12
72426071|NCT01863043|144363800|SUPERIORITY|||||||0.28|||||||Mixed Models Analysis|||||||0.28
72426072|NCT01863043|144363801|SUPERIORITY|||||||0.15|||||||Mixed Models Analysis|||||||0.15
72426073|NCT01863043|144363802|SUPERIORITY|||||||0.03|||||||Mixed Models Analysis|||||||0.03
72426074|NCT01863043|144363803|SUPERIORITY|||||||0.03|||||||Mixed Models Analysis|||||||0.03
72426075|NCT01863043|144363804|SUPERIORITY|||||||0.59|||||||Accelerated failure time regression mode|||||||0.59
72426076|NCT01863043|144363805|SUPERIORITY|||||||0.64|||||||Accelerated failure time regression mode|||||||0.64
72335463|NCT00433160|144193817|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Percent Change to Week 24. No adjustment for multiplicity was performed.|Wilcoxon's Rank Sum Test|||Null hypothesis: there is no difference in the percent change in BAP after 24-week treatment between the two treatment groups.||||<0.001
72335464|NCT00433160|144193817|SUPERIORITY_OR_OTHER|||||||0.06||95.0||||P-value for Percent Change to Week 52. No adjustment for multiplicity was performed.|Wicoxon's Rank Sum Test|||Null hypothesis: there is no difference in the percent change in BAP after 52-week treatment between the two treatment groups.||||0.060
72335465|NCT00433160|144193817|SUPERIORITY_OR_OTHER|||||||0.13||95.0||||P-value for Percent Change to Last Measurement. No adjustment for multiplicity was performed.|Wilcoxon's Rank Sum Test|||Null hypothesis: there is no difference in the percent change in BAP from baseline to the last measurement point between the two treatment groups.||||0.130
72335466|NCT00433160|144193818|SUPERIORITY_OR_OTHER|||||||0.976||95.0||||P-value for Percent Change to Week 4. No adjustment for multiplicity was performed.|Wilcoxon's Rank Sum Test|||Null hypothesis: there is no difference in the percent change in CTX after 4-week treatment between the two treatment groups.||||0.976
72335467|NCT00433160|144193818|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Percent Change to Week 12. No adjustment for multiplicity was performed.|Wilcoxon's Rank Sum Test|||Null hypothesis: there is no difference in the percent change in CTX after 12-week treatment between the two treatment groups.||||<0.001
72335468|NCT00433160|144193818|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Percent Change to Week 24. No adjustment for multiplicity was performed.|Wilcoxon's Rank Sum Test|||Null hypothesis: there is no difference in the percent change in CTX after 24-week treatment between the two treatment groups.||||<0.001
72335469|NCT00433160|144193818|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Percent Change to Week 52. No adjustment for multiplicity was performed.|Wilcoxon's Rank Sum Test|||Null hypothesis: there is no difference in the percent change in CTX after 52-week treatment between the two treatment groups.||||<0.001
72335470|NCT00433160|144193818|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Percent Change to Last Measurement. No adjustment for multiplicity was performed.|Wilcoxon's Rank Sum Test|||Null hypothesis: there is no difference in the percent change in CTX from baseline to the last measurement point between the two treatment groups.||||<0.001
72335471|NCT02793817|144193837|SUPERIORITY||Difference in percentage of responders|8.3||||0.0105|TWO_SIDED|95.0|2.0|14.7||To account for multiplicity, a step-down testing procedure was applied, whereby inference for a test in the pre-defined hierarchy was dependent upon statistical significance having been demonstrated for the previous test in the hierarchy.|Chi-squared|Without adjustment for any covariates|Estimated Value is the between-group difference for % of responders and is expressed as a percentage.|P-values were based on 2-sided chi-squared tests (unadjusted) wherein the a priori significance level was 0.05.||14.7|2.0|0.0105
72426077|NCT01863043|144363806|SUPERIORITY|||||||0.95|||||||Accelerated failure time regression mode|||||||0.95
72426078|NCT01863043|144363807|SUPERIORITY|||||||0.95|||||||Wilcoxon (Mann-Whitney)|||||||0.95
72335472|NCT02793817|144193838|SUPERIORITY||Difference in percentage of responders|20.0|||<|0.0001|TWO_SIDED|95.0|11.6|28.4||To account for multiplicity, a step-down closed testing procedure was applied, whereby inference for a test in the pre-defined hierarchy was dependent upon statistical significance having been demonstrated for the previous test in the hierarchy.|Chi-squared|Without adjustment for any covariates|Estimated Value is the between-group difference for % of responders and is expressed as a percentage.|P-values were based on 2-sided chi-squared test (unadjusted), wherein a priori significance level was 0.05||28.4|11.6|<0.0001
72426079|NCT01863043|144363808|SUPERIORITY|||||||0.23|||||||Accelerated failure time regression mode|||||||0.23
72426080|NCT01863043|144363809|SUPERIORITY|||||||0.98|||||||Mixed Models Analysis|||||||0.98
72426081|NCT01863043|144363810|SUPERIORITY|||||||0.01|||||||Accelerated failure time regression mode|||||||0.01
72426082|NCT01863043|144363811|SUPERIORITY|||||||0.08|||||||Mixed Models Analysis|||||||0.08
72426083|NCT01863043|144363812|SUPERIORITY|||||||0.25|||||||Mixed Models Analysis|||||||0.25
72426084|NCT01863043|144363814|SUPERIORITY|||||||0.27|||||||Wilcoxon (Mann-Whitney)|||||||0.27
72426085|NCT01863043|144363815|SUPERIORITY|||||||0.17|||||||Mixed Models Analysis|||||||0.17
72426086|NCT01863043|144363816|SUPERIORITY|||||||0.17|||||||Mixed Models Analysis|||||||0.17
72426087|NCT01863043|144363817|SUPERIORITY|||||||0.43|||||||Mixed Models Analysis|||||||0.43
72426088|NCT01863043|144363818|SUPERIORITY|||||||0.694|||||||Wilcoxon (Mann-Whitney)|||||||0.694
72426089|NCT01863043|144363819|SUPERIORITY|||||||0.97|||||||Accelerated failure time regression mode|||||||0.97
72426090|NCT01863043|144363820|SUPERIORITY|||||||0.6|||||||Mixed Models Analysis|||||||0.60
72335473|NCT02793817|144193839|SUPERIORITY||Difference in percentage of responders|17.1|||<|0.0001|TWO_SIDED|95.0|9.1|25.0||P-value was based on a 2-sided chi-squared test (unadjusted) wherein the a priori significance level was 0.0167 for each secondary endpoint. Overall alpha for all secondary endpoints was controlled at 0.05.|Chi-squared|Without adjustment for any covariates|Estimated Value is the between-group difference for % of responders and is expressed as a percentage.|||25.0|9.1|<0.0001
72335474|NCT02793817|144193840|SUPERIORITY||Difference in percentage of responders|19.0|||<|0.0001|TWO_SIDED|95.0|11.0|26.9||P-value was based on a 2-sided chi-squared test (unadjusted) wherein the a priori significance level was 0.0167 for each secondary endpoint. Overall alpha for all secondary endpoints was controlled at 0.05.|Chi-squared|Without adjustment for any covariates|Estimated Value is the between-group difference for % of responders and is expressed as a percentage.|||26.9|11.0|<0.0001
72335475|NCT02793817|144193841|SUPERIORITY||Mean Difference (Final Values)|-0.18||||0.0078|TWO_SIDED|95.0|-0.31|-0.05|||Chi-squared|Without adjustment for any covariates|Estimated Value is the between-group difference for change from BL.|P-value was based on a 2-sided chi-squared test (unadjusted) wherein the a priori significance level was 0.0167 for each secondary endpoint. Overall alpha for all secondary endpoints was controlled at 0.05.||-0.05|-0.31|0.0078
72335476|NCT02793817|144193842|SUPERIORITY||Mean Difference (Final Values)|-0.24||||0.0005|TWO_SIDED|95.0|-0.38|-0.11||P-values have no inferential value for post hoc evaluations.|Chi-squared|Without any adjustment for covariates|Estimated Value is the between-group difference in change from BL|||-0.11|-0.38|0.0005
72335477|NCT02793817|144193843|SUPERIORITY||Mean Difference (Final Values)|-0.15||||0.0169|TWO_SIDED|95.0|-0.28|-0.03||P-values have no inferential value for post hoc evaluations.|Chi-squared|Without adjustments for any covariates.|Estimated Value is the between-group difference for change from BL|||-0.03|-0.28|0.0169
72335478|NCT03222973|144193844|SUPERIORITY||Treatment Difference|0.15||||0.1479|TWO_SIDED|95.0|-0.05|0.35||P-values are based on the Mixed Model for Repeated Measures (MMRM) adjusted for background DMT group, baseline magnetization transfer ratio (MTR)/diffusion tensor imaging (DTI) category and baseline component assessments.|MMRM|||Over 72 weeks: Overall Response Score||0.35|-0.05|0.1479
72335479|NCT03222973|144193846|SUPERIORITY||Odds Ratio (OR)|1.08||||0.7682|TWO_SIDED|95.0|0.65|1.79||Odds ratio (active vs. placebo), 95% CI and p-value are based on logistic regression adjusted for background DMT group, baseline MTR/DTI category and baseline component assessments.|Regression, Logistic|||||1.79|0.65|0.7682
72335480|NCT03222973|144193847|SUPERIORITY||Odds Ratio (OR)|0.71||||0.2131|TWO_SIDED|95.0|0.41|1.22||Odds ratio (active vs. placebo), 95% CI and p-value are based on logistic regression adjusted for background DMT group, baseline MTR/DTI category and baseline component assessments.|Regression, Logistic|||||1.22|0.41|0.2131
72335481|NCT03222973|144193848|SUPERIORITY||Odds Ratio (OR)|0.81||||0.4654|TWO_SIDED|95.0|0.47|1.41||Odds ratio (active vs. placebo), 95% CI and p-value are based on logistic regression adjusted for background DMT group, baseline MTR/DTI category and baseline component assessments.|Regression, Logistic|||||1.41|0.47|0.4654
72335482|NCT03222973|144193849|SUPERIORITY||Odds Ratio (OR)|1.78||||0.0417|TWO_SIDED|95.0|1.02|3.11||Odds ratio (active vs. placebo), 95% CI and p-value are based on logistic regression adjusted for background DMT group, baseline MTR/DTI category and baseline component assessments.|Regression, Logistic|||||3.11|1.02|0.0417
72335483|NCT03222973|144193850|SUPERIORITY||Odds Ratio (OR)|1.35||||0.2908|TWO_SIDED|95.0|0.78|2.33||Odds ratio (active vs. placebo), 95% CI and p-value are based on logistic regression adjusted for background DMT group, baseline MTR/DTI category and baseline component assessments.|Regression, Logistic|||||2.33|0.78|0.2908
72426091|NCT01863043|144363821|SUPERIORITY|||||||0.25|||||||Mixed Models Analysis|||||||0.25
72426092|NCT01863043|144363822|SUPERIORITY|||||||0.001|||||||Mixed Models Analysis|||||||0.001
72335484|NCT02080481|144193862|SUPERIORITY_OR_OTHER||ratio of geometric means|0.68|||<|0.001|TWO_SIDED|95.0|0.61|0.76|||Regression, Linear|intraoperative management strategy was imbalanced between randomized groups and was adjusted for in the linear regression model.||||0.76|0.61|< 0.001
72335485|NCT02080481|144193863|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.55||||0.56|TWO_SIDED|98.3|0.25|9.6|||Regression, Logistic|intraoperative management strategy was imbalanced between randomized groups and was adjusted for in the logistic regression model.|Odds ratio for Infiniti Plus versus conventional needle patients|||9.6|0.25|0.56
72335486|NCT02080481|144193864|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.13||||0.06|TWO_SIDED|98.3|0.01|1.78||Intraoperative management strategy was imbalanced between groups and adjusted for in the logistic regression model.|Regression, Logistic|||||1.78|0.01|0.06
72335487|NCT02080481|144193865|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.4||||0.74|TWO_SIDED|98.3|-7.7|14.6|||Regression, Linear|Intraoperative management strategy was imbalanced between randomized groups and adjusted for in the linear regression model.||||14.6|-7.7|0.74
72426093|NCT01863043|144363823|SUPERIORITY|||||||0.002|||||||Mixed Models Analysis|||||||0.002
72426094|NCT01863043|144363824|SUPERIORITY|||||||0.03|||||||Mixed Models Analysis|||||||0.03
72426095|NCT01863043|144363825|SUPERIORITY|||||||0.56|||||||Mixed Models Analysis|||||||0.56
72426096|NCT01863043|144363826|SUPERIORITY|||||||0.59|||||||Mixed Models Analysis|||||||0.59
72426097|NCT01863043|144363827|SUPERIORITY|||||||0.888|||||||Mixed Models Analysis|||||||0.888
72426098|NCT01863043|144363828|SUPERIORITY|||||||0.694|||||||Regression, Linear|||||||0.694
72426099|NCT01863043|144363829|SUPERIORITY|||||||0.248|||||||general linear mixed model|||||||0.248
72426100|NCT01863043|144363830|SUPERIORITY|||||||0.694|||||||general linear mixed model|||||||0.694
72426101|NCT01863043|144363831|SUPERIORITY|||||||0.195|||||||Regression, Linear|||||||0.195
72426102|NCT01580098|144363844|SUPERIORITY_OR_OTHER|||||||0.025|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.025
72426103|NCT01580098|144363845|SUPERIORITY_OR_OTHER|||||||0.182|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Blood pressure: diastolic||||0.182
72426104|NCT00345384|144363869|SUPERIORITY_OR_OTHER||Precentage Difference|41.0||||0.03|TWO_SIDED|95.0|||||t-test, 2 sided||The percentage in opioid use by the dexmedetomidine group in comparison to the placebo for the period of time on study drug is calculated as follows: numerator = 29, denominator = 49.|||||0.03
72426105|NCT00345384|144363869|SUPERIORITY_OR_OTHER||Percentage difference|35.0||||0.04|TWO_SIDED|95.0|||||t-test, 2 sided||A measure of opioid use, weighted for total time on study drug. This is examined by a comparison of the dexmedetomidine group to the placebo group: numerator = 35, denominator = 54.|||||0.04
72426106|NCT00345384|144363870|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED||||||t-test, 2 sided|||The p-value reported in this table corresponds with the 6 to 16 hour time frame.||||0.02
72426107|NCT01108510|144363883|NON_INFERIORITY_OR_EQUIVALENCE|Null hypothesis: ATV+COBI+FTC/TDF group was at least 12% worse than the ATV+RTV+FTC/TDF group; alternative hypothesis: ATV+COBI+FTC/TDF group was less than 12% worse than the ATV+RTV+FTC/TDF group. ATV+COBI+FTC/TDF was noninferior if the lower bound of the 2-sided 95.2% confidence interval (CI) (COBI group - RTV group) was \> -12%.|Difference in percentages|-2.2|||||TWO_SIDED|95.2|-7.4|3.0|||||Difference in percentages of success and its 95.2% confidence interval (CI) were calculated based on baseline HIV-1 RNA stratum-adjusted Mantel-Haenszel (MH) proportion.|700 planned subjects had 95% power to evaluate noninferiority assuming a response rate of 79.5% for both arms and a noninferiority margin of 12%.||3.0|-7.4|
72426108|NCT01108510|144363884|NON_INFERIORITY_OR_EQUIVALENCE|The null hypothesis was that the response rate in the ATV+COBI+FTC/TDF group was at least 12% worse than the response rate in ATV+RTV+FTC/TDF group; the alternative hypothesis was that the response rate in the ATV+COBI+FTC/TDF group was less than 12% worse than that in the ATV+RTV+FTC/TDF group.|Difference in percentages|-1.4|||||TWO_SIDED|95.0|-7.6|4.7|||||Difference in percentages of success and its 95% CI were calculated based on baseline HIV-1 RNA stratum-adjusted MH proportion.|||4.7|-7.6|
72426109|NCT01108510|144363885|NON_INFERIORITY_OR_EQUIVALENCE|The null hypothesis was that the response rate in the ATV+COBI+FTC/TDF group was at least 12% worse than the response rate in ATV+RTV+FTC/TDF group; the alternative hypothesis was that the response rate in the ATV+COBI+FTC/TDF group was less than 12% worse than that in the ATV+RTV+FTC/TDF group.|Difference in percentages|-2.1|||||TWO_SIDED|95.0|-8.7|4.5|||||Difference in percentages of success and its 95% CI were calculated based on baseline HIV-1 RNA stratum-adjusted MH proportion.|||4.5|-8.7|
72426110|NCT01108510|144363886|NON_INFERIORITY_OR_EQUIVALENCE|The null hypothesis was that the response rate in the ATV+COBI+FTC/TDF group was at least 12% worse than the response rate in ATV+RTV+FTC/TDF group; the alternative hypothesis was that the response rate in the ATV+COBI+FTC/TDF group was less than 12% worse than that in the ATV+RTV+FTC/TDF group.|Difference in percentages|-8.0|||||TWO_SIDED|95.0|-22.2|6.3|||||Difference in percentages of success and its 95% CI were calculated based on baseline HIV-1 RNA stratum-adjusted MH proportion.|||6.3|-22.2|
72426111|NCT01108510|144363887|SUPERIORITY_OR_OTHER||Difference in least squares mean (LSM)|-5.0||||0.67|TWO_SIDED|95.0|-28.0|18.0||P-values were obtained from an ANOVA model including baseline HIV-1 RNA category in the model.|ANOVA||The difference in LSM and its 95% CI were computed using ANOVA model, including baseline HIV-1 RNA category in the model.|||18|-28|0.67
72426112|NCT01108510|144363888|SUPERIORITY_OR_OTHER||Difference in LSM|-10.0||||0.51|TWO_SIDED|95.0|-38.0|19.0||P-values were obtained from an ANOVA model including baseline HIV-1 RNA category in the model.|ANOVA||The difference in LSM and its 95% CI were computed using ANOVA model, including baseline HIV-1 RNA category in the model.|||19|-38|0.51
72426113|NCT01108510|144363889|SUPERIORITY_OR_OTHER||Difference in LSM|-22.0||||0.18|TWO_SIDED|95.0|-54.0|10.0||P-values were obtained from an ANOVA model including baseline HIV-1 RNA category in the model.|ANOVA||The difference in LSM and its 95% CI were computed using ANOVA model, including baseline HIV-1 RNA category in the model.|||10|-54|0.18
72426114|NCT01108510|144363890|SUPERIORITY_OR_OTHER||Difference in LSM|6.0||||0.84|TWO_SIDED|95.0|-55.0|67.0||P-values were obtained from an ANOVA model including baseline HIV-1 RNA category in the model.|ANOVA||The difference in LSM and its 95% CI were computed using ANOVA model, including baseline HIV-1 RNA category in the model.|||67|-55|0.84
72426115|NCT03959592|144363942|OTHER|||||||0.14|||||||Generalized Estimating Equations|||||||0.14
72426116|NCT03959592|144363943|OTHER|||||||0.423|||||||Generalized Estimating Equations|||||||0.423
72426117|NCT03959592|144363946|OTHER|||||||0.985|||||||Generalized Estimating Equations|||||||0.985
72426118|NCT03959592|144363947|OTHER|||||||0.545|||||||Generalized Estimating Equations|||||||0.545
72426119|NCT01003639|144363949|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.71||||0.05|TWO_SIDED|95.0|0.0|1.43|||ANCOVA|||||1.43|0|0.05
72426120|NCT04362137|144363955|SUPERIORITY||Odds Ratio (OR)|0.91||||0.769|TWO_SIDED|95.0|0.48|1.73|||Regression, Logistic||Comparison is ruxolitinib 5 mg/placebo. An odds ratio \< 1 favors the ruxolitinib 5 mg arm|||1.73|0.48|0.769
72426121|NCT04362137|144363957|SUPERIORITY||Odds Ratio (OR)|0.89||||0.647|TWO_SIDED|95.0|0.55|1.46|||Regression, Logistic||Comparison is ruxolitinib 5 mg/placebo. An odds ratio \> 1 favors the ruxolitinib 5 mg arm|Day 15||1.46|0.55|0.647
72426122|NCT04362137|144363957|SUPERIORITY||Odds Ratio (OR)|1.0||||0.997|TWO_SIDED|95.0|0.52|1.92|||Regression, Logistic||Comparison is ruxolitinib 5 mg/placebo. An odds ratio \> 1 favors the ruxolitinib 5 mg arm|Day 29||1.92|0.52|0.997
72426123|NCT04362137|144363958|SUPERIORITY||Odds Ratio (OR)|0.98||||0.946|TWO_SIDED|95.0|0.51|1.87|||Regression, Logistic||Comparison is ruxolitinib 5 mg/placebo. An odds ratio \> 1 favors the ruxolitinib 5 mg arm|Day 15||1.87|0.51|0.946
72426124|NCT04362137|144363958|SUPERIORITY||Odds Ratio (OR)|0.79||||0.573|TWO_SIDED|95.0|0.35|1.79|||Regression, Logistic||Comparison is ruxolitinib 5 mg/placebo. An odds ratio \> 1 favors the ruxolitinib 5 mg arm|Day 29||1.79|0.35|0.573
72426125|NCT04362137|144363959|SUPERIORITY||Odds Ratio (OR)|0.75||||0.532|TWO_SIDED|95.0|0.31|1.83|||Regression, Logistic||Comparison is ruxolitinib 5 mg/placebo. An odds ratio \< 1 favors the ruxolitinib 5 mg arm|Day 15||1.83|0.31|0.532
72426126|NCT04362137|144363959|SUPERIORITY||Odds Ratio (OR)|1.18||||0.764|TWO_SIDED|95.0|0.4|3.49|||Regression, Logistic||Comparison is ruxolitinib 5 mg/placebo. An odds ratio \< 1 favors the ruxolitinib 5 mg arm|Day 29||3.49|0.40|0.764
72426127|NCT04362137|144363960|SUPERIORITY||Hazard Ratio (HR)|1.11||||0.33|TWO_SIDED|95.0|0.9|1.37|||Proportional hazards model||Between group comparison using competing risk framework. A hazard ratio \> 1 favors the ruxolitinib 5 mg arm|||1.37|0.90|0.330
72426128|NCT04362137|144363961|SUPERIORITY||Least squares (LS) mean|-0.03|STANDARD_ERROR_OF_MEAN|0.144||0.831|TWO_SIDED|95.0|-0.31|0.25|||ANCOVA|||Day 15||0.25|-0.31|0.831
72426129|NCT04362137|144363961|SUPERIORITY||LS Mean|0.08|STANDARD_ERROR_OF_MEAN|0.155||0.624|TWO_SIDED|95.0|-0.23|0.38|||ANCOVA|||Day 29||0.38|-0.23|0.624
72426130|NCT04362137|144363962|SUPERIORITY||Odds Ratio (OR)|0.94||||0.944|TWO_SIDED|95.0|0.2|5.57|||Regression, Logistic||Comparison is ruxolitinib 5 mg/placebo. An odds ratio \< 1 favors the ruxolitinib 5 mg arm|Day 15||5.57|0.20|0.944
72426131|NCT04362137|144363962|SUPERIORITY||Odds Ratio (OR)|1.21||||0.775|TWO_SIDED|95.0|0.35|5.11|||Regression, Logistic||Comparison is ruxolitinib 5 mg/placebo. An odds ratio \< 1 favors the ruxolitinib 5 mg arm|Day 29||5.11|0.35|0.775
72426132|NCT04362137|144363963|SUPERIORITY||Odds Ratio (OR)|0.99||||0.987|TWO_SIDED|95.0|0.45|2.21|||Regression, Logistic||Comparison is ruxolitinib 5 mg/placebo. An odds ratio \< 1 favors the ruxolitinib 5 mg arm|||2.21|0.45|0.987
72426133|NCT04362137|144363964|SUPERIORITY||Hazard Ratio (HR)|1.04||||0.738|TWO_SIDED|95.0|0.84|1.28|||Proportional hazards model||Between group comparison using competing risk framework. A hazard ratio \> 1 favors the ruxolitinib 5 mg arm|||1.28|0.84|0.738
72426134|NCT04362137|144363965|SUPERIORITY||Hazard Ratio (HR)|1.02||||0.869|TWO_SIDED|95.0|0.84|1.23|||Proportional hazards model||Between group comparison using competing risk framework. A hazard ratio \> 1 favors the ruxolitinib 5 mg arm|||1.23|0.84|0.869
72426135|NCT04362137|144363968|SUPERIORITY||Odds Ratio (OR)|0.61||||0.325|TWO_SIDED|95.0|0.23|1.63|||Regression, Logistic||Comparison is ruxolitinib 5 mg/placebo. An odds ratio \> 1 favors the ruxolitinib 5 mg arm|Day 15||1.63|0.23|0.325
72426136|NCT04362137|144363968|SUPERIORITY||Odds Ratio (OR)|1.22|||||TWO_SIDED|95.0|0.25|5.4||P-value was not estimable because \>97% patients fall into one category (responders) in both groups, and very few patients fall into the other one (non-responders), which made the logistic regression model fail to converge even with Firth's correction|Regression, Logistic||Comparison is ruxolitinib 5 mg/placebo. An odds ratio \> 1 favors the ruxolitinib 5 mg arm|Day 29||5.40|0.25|
72426137|NCT01234649|144364012|SUPERIORITY||||||<|0.04|||||||ANOVA|||Factorial repeated measures design||||<0.04
72426138|NCT01234649|144364013|SUPERIORITY||||||<|0.005|||||||ANOVA|||Factorial repeated measures ANOVA||||<.005
72426139|NCT01234649|144364014|SUPERIORITY||||||<|0.011|||||||ANOVA|||Factorial repeated measures ANOVA||||<0.011
72426140|NCT01234649|144364015|SUPERIORITY||||||>|0.05|||||||ANOVA|||Nested repeated measures design||||>0.05
72426141|NCT01234649|144364016|SUPERIORITY||||||<|0.03|||||||ANOVA|||Factorial repeated measures ANOVA||||<0.03
72426142|NCT01234649|144364017|SUPERIORITY||||||>|0.05|||||||ANOVA|||Factorial repeated measures ANOVA||||>0.05
72426143|NCT01234649|144364018|SUPERIORITY||||||<|0.048|||||||ANOVA|||Factorial repeated measures ANOVA||||<0.048
72426144|NCT01234649|144364019|SUPERIORITY||||||<|0.04|||||||ANOVA|||||||<0.04
72426145|NCT01234649|144364020|SUPERIORITY||||||<|0.047|||||||ANOVA|||Factorial repeated measures ANOVA||||<0.047
72426146|NCT01234649|144364021|SUPERIORITY||||||<|0.023|||||||ANOVA|||Factorial repeated measures ANOVA||||<0.023
72426147|NCT01234649|144364022|SUPERIORITY||||||>|0.05|||||||ANOVA|||Factorial repeated measures ANOVA||||>0.05
72426148|NCT01234649|144364023|SUPERIORITY|||||||0.042|||||||ANOVA|||Factorial repeated measures ANOVA||||0.042
72426149|NCT01234649|144364024|SUPERIORITY||||||>|0.05|||||||ANOVA|||Factorial repeated measures ANOVA||||>0.05
72426150|NCT01234649|144364025|SUPERIORITY||||||>|0.05|||||||ANOVA|||Factorial repeated measures ANOVA||||>0.05
72426151|NCT01234649|144364026|SUPERIORITY||||||>|0.05|||||||ANOVA|||Factorial repeated measures ANOVA||||>0.05
72426152|NCT01234649|144364027|SUPERIORITY||||||<|0.046|||||||ANOVA|||Factorial repeated measures ANOVA||||<0.046
72426153|NCT01234649|144364028|SUPERIORITY||||||<|0.049|||||||ANOVA|||Factorial repeated measures ANOVA||||<0.049
72426154|NCT01234649|144364029|SUPERIORITY||||||>|0.05|||||||ANOVA|||Factorial repeated measures ANOVA||||>0.05
72426155|NCT01234649|144364030|SUPERIORITY||||||>|0.05|||||||ANOVA|||Factorial repeated measures ANOVA||||>0.05
72426156|NCT01234649|144364031|SUPERIORITY||||||>|0.05|||||||ANOVA|||Factorial repeated measures ANOVA||||>0.05
72426157|NCT01234649|144364032|SUPERIORITY||||||>|0.05|||||||ANOVA|||Factorial repeated measures ANOVA||||>0.05
72426158|NCT01234649|144364033|SUPERIORITY||||||>|0.05|||||||ANOVA|||Factorial repeated measures ANOVA||||>0.05
72426159|NCT00318149|144364038|NON_INFERIORITY|Non inferiority criteria: The upper limit (UL) of the 2-sided 98.75% confidence interval (CI) on geometric mean ratio of influenza-specific T-cells (between Fluarix 18-40 Y Group and Fluarix-AS25 Group) was smaller than (\<) 2.0.|Geometric mean ratio|0.9|||||TWO_SIDED|98.75|0.7|1.16||||||Demonstration of non inferiority of the influenza adjuvanted vaccine Fluarix-AS25 administered to elderly subjects (aged 65 years and older) as compared to the licensed influenza vaccine Fluarix administered to adults (aged 18-40 years) in terms of frequency of influenza-specific CD4 T-cells producing at least 2 different cytokines (CD40L, IL-2, TNF-α or IFN-γ), 21 days post-vaccination.||1.16|0.7|
72426160|NCT00318149|144364038|NON_INFERIORITY|Non inferiority criteria: The upper limit (UL) of the 2-sided 98.75% confidence interval (CI) on geometric mean ratio of influenza-specific T-cells (between Fluarix 18-40 Y Group and Fluarix-AS50 Group) was smaller than (\<) 2.0.|Geometric mean ratio|1.05|||||TWO_SIDED|98.75|0.71|1.56||||||Demonstration of non inferiority of the influenza adjuvanted vaccine Fluarix-AS50 administered to elderly subjects (aged 65 years and older) as compared to the licensed influenza vaccine Fluarix administered to adults (aged 18-40 years) in terms of frequency of influenza-specific CD4 T-cells producing at least 2 different cytokines (CD40L, IL-2, TNF-α or IFN-γ), 21 days post-vaccination.||1.56|0.71|
72426161|NCT00318149|144364038|NON_INFERIORITY|Non inferiority criteria: The upper limit (UL) of the 2-sided 98.75% confidence interval (CI) on geometric mean ratio of influenza-specific T-cells (between Fluarix 18-40 Y Group and Fluarix-AS01B Group) was smaller than (\<) 2.0.|Geometric mean ratio|1.04|||||TWO_SIDED|98.75|0.79|1.38||||||Demonstration of non inferiority of the influenza adjuvanted vaccine Fluarix-AS01B administered to elderly subjects (aged 65 years and older) as compared to the licensed influenza vaccine Fluarix administered to adults (aged 18-40 years) in terms of frequency of influenza-specific CD4 T-cells producing at least 2 different cytokines (CD40L, IL-2, TNF-α or IFN-γ), 21 days post-vaccination.||1.38|0.79|
72426162|NCT00318149|144364038|NON_INFERIORITY|Non inferiority criteria: The upper limit (UL) of the 2-sided 98.75% confidence interval (CI) on geometric mean ratio of influenza-specific T-cells (between Fluarix 18-40 Y Group and Fluarix-AS01E Group) was smaller than (\<) 2.0.|Geometric mean ratio|1.07|||||TWO_SIDED|98.75|0.79|1.44||||||Demonstration of non inferiority of the influenza adjuvanted vaccine Fluarix-AS01E administered to elderly subjects (aged 65 years and older) as compared to the licensed influenza vaccine Fluarix administered to adults (aged 18-40 years) in terms of frequency of influenza-specific CD4 T-cells producing at least 2 different cytokines (CD40L, IL-2, TNF-α or IFN-γ), 21 days post-vaccination.||1.44|0.79|
72426163|NCT01304082|144364051|SUPERIORITY_OR_OTHER|||||||0.7535||||||Bonferroni correction for pairwise comparisons|non-parametric Friedman ANOVA test|||"Analysis: Non-parametric Friedman ANOVA test on rank-transformed outcome with Bonferroni correction for pairwise comparisons.~Null hypothesis: No difference between the groups"||||0.7535
72426164|NCT01304082|144364052|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Bonferroni correction for pairwise comparisons|non-parametric Friedman ANOVA test|||"Analysis: Non-parametric Friedman ANOVA test on rank-transformed outcome with Bonferroni correction for pairwise comparisons.~Null hypothesis: No difference between the groups"||||<0.0001
72426165|NCT01304082|144364053|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Bonferroni correction for pairwise comparisons|non-parametric Friedman ANOVA test|||"Analysis: Non-parametric Friedman ANOVA test on rank-transformed outcome with Bonferroni correction for pairwise comparisons.~Null hypothesis: No difference between the groups"||||<0.0001
72426166|NCT01304082|144364054|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Bonferroni correction for pairwise comparisons|non-parametric Friedman ANOVA test|||"Analysis: Non-parametric Friedman ANOVA test on rank-transformed outcome with Bonferroni correction for pairwise comparisons.~Null hypothesis: No difference between the groups"||||<0.0001
72426167|NCT02306122|144364059|SUPERIORITY||Risk Difference (RD)|-0.015|STANDARD_ERROR_OF_MEAN|0.034|<|0.01|TWO_SIDED||||||Regression, Logistic||Comparator is control arm|||||<0.01
72426168|NCT02306122|144364059|SUPERIORITY||Risk Difference (RD)|-0.015|STANDARD_ERROR_OF_MEAN|0.041|<|0.01|TWO_SIDED||||||Regression, Logistic||Comparator is control arm|||||<0.01
72426169|NCT02306122|144364059|SUPERIORITY||Risk Difference (RD)|0.012|STANDARD_ERROR_OF_MEAN|0.029|<|0.01|TWO_SIDED||||||Regression, Logistic||Comparator is control arm|||||<0.01
72426170|NCT02306122|144364060|SUPERIORITY||Mean Difference (Final Values)|-0.128|STANDARD_ERROR_OF_MEAN|2.523|<|0.01|TWO_SIDED||||||Regression, Linear||Comparator is the control arm|||||<0.01
72426171|NCT02306122|144364060|SUPERIORITY||Mean Difference (Final Values)|-1.582|STANDARD_ERROR_OF_MEAN|2.997|<|0.01|TWO_SIDED||||||Regression, Linear||Comparator is the control arm|||||<0.01
72426172|NCT02306122|144364060|SUPERIORITY||Mean Difference (Final Values)|0.308|STANDARD_ERROR_OF_MEAN|2.38|<|0.01|TWO_SIDED||||||Regression, Linear||Comparator is the control arm|||||<0.01
72426173|NCT02306122|144364061|SUPERIORITY||Risk Difference (RD)|-0.043|STANDARD_ERROR_OF_MEAN|0.068|<|0.01|TWO_SIDED||||||Regression, Logistic||Comparator is the information arm|||||<0.01
72426174|NCT02306122|144364061|SUPERIORITY||Risk Difference (RD)|0.06|STANDARD_ERROR_OF_MEAN|0.063|<|0.01|TWO_SIDED||||||Regression, Logistic||Comparator is the information arm|||||<0.01
72426175|NCT02306122|144364062|SUPERIORITY||Risk Difference (RD)|0.42|STANDARD_ERROR_OF_MEAN|0.071|<|0.01|TWO_SIDED||||||Regression, Logistic||Comparator is the choice arm|||||<0.01
72426176|NCT02262260|144364063|NON_INFERIORITY|"In order to demonstrate that the wait and extend regimen of ranibizumab is non-inferior to the posology described in the prescribing information, mean change in BCVA at month 12 from the baseline visit were determined for both treatment groups, and a comparison was made between the two groups using the Independent Samples t-test."||||||0.5|||||||Wilcoxon (Mann-Whitney)|||||||0.5
72426177|NCT02262260|144364064|NON_INFERIORITY|"In order to demonstrate that the wait and extend regimen of ranibizumab is non-inferior to the posology described in the prescribing information, mean change in Central Retinal Thickness determined with Optical Coherence Tomography for both eyes were calculated for both groups and were compared using the Mann Whitney u test."||||||0.082|||||||Wilcoxon (Mann-Whitney)|||||||0.082
72426178|NCT02262260|144364067|NON_INFERIORITY|Comparison was made between the two groups using the Independent Samples t-test.||||||0.095|||||||Chi-squared|||||||0.095
72426179|NCT02262260|144364068|NON_INFERIORITY|comparison was made between the two groups using the Independent Samples t-test.||||||0.072|||||||Chi-squared|||||||0.072
72426180|NCT02262260|144364069|NON_INFERIORITY|comparison was made between the two groups using the Independent Samples t-test||||||0.466|||||||Chi-squared|||||||0.466
72426181|NCT01794117|144364082|SUPERIORITY|||||||0.033|||||||Wilcoxon Signed Rank Test|||||||0.033
72426182|NCT02322814|144364093|SUPERIORITY||Hazard Ratio (HR)|0.73||||0.247||95.0|0.43|1.24|||Log Rank|||||1.24|0.43|0.2470
72426183|NCT02322814|144364095|SUPERIORITY||Hazard Ratio (HR)|1.18||||0.5912||95.0|0.65|2.13|||Log Rank|||||2.13|0.65|0.5912
72426184|NCT02459093|144364121|SUPERIORITY||Risk Ratio (RR)|0.61||||0.04|TWO_SIDED|95.0|0.37|0.99|||Chi-squared|||||0.99|0.37|0.04
72426185|NCT02459093|144364122|SUPERIORITY||Risk Ratio (RR)|0.6||||0.05|TWO_SIDED|95.0|0.36|1.01|||Chi-squared|||||1.01|0.36|0.05
72426186|NCT01744860|144364176|SUPERIORITY_OR_OTHER||Kappa coefficient|0.8611|||||TWO_SIDED|95.0|0.8125|0.9097||||||"Kappa coefficient was used to compare the concordance between INCa Molecular Genetics Laboratory in-house methods and Cobas 4800 Mutation Test."||0.9097|0.8125|
72426187|NCT02736968|144364205|SUPERIORITY||Difference in Proportions|0.0|||>|0.999|TWO_SIDED|95.0|-0.12|0.12||No adjustment for multiple comparisons was made. The a priori threshold for statistical significance is 0.05.|Fisher Exact||Adjusted Wald Intervals|The null hypothesis is that the probability of resolution of diarrhea by Day 5 for participants receiving auranofin is equal to that for those receiving placebo.||0.12|-0.12|>0.999
72426188|NCT02736968|144364206|SUPERIORITY||Difference in Proportions|0.0|||>|0.999|TWO_SIDED|95.0|-0.34|0.34||No adjustment for multiple comparisons was made. The a priori threshold for statistical significance is 0.05.|Fisher Exact||Adjusted Wald Intervals|The null hypothesis is that the probability of parasitological response by Day 5 for participants receiving auranofin is equal to that for those receiving placebo.||0.34|-0.34|>0.999
72426189|NCT02736968|144364211|SUPERIORITY|||||||0.142||||||No adjustment for multiple comparisons was made. The a priori threshold for statistical significance is 0.05.|Log Rank|||The null hypothesis is that there is no difference in time to resolution of diarrhea between treatment arms, with a two-sided alternative.||||0.142
72426190|NCT01861457|144364219|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.01|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<0.01
72426191|NCT01861457|144364220|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.01|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<0.01
72426192|NCT02049710|144364221|OTHER||Mean Difference (Final Values)|5.06|||||TWO_SIDED|95.0|3.0|15.0||||||Summation scores are reported across 3 items measured on a 5-point scale from 1(not at all sure)to5(very sure), which loaded together on a principal components analysis of the baseline data.The summation score thus represents a theoretical range from 3 to 15.The 3 items were as follows:Indicate How Sure You are that You Would be Able to Perform Each of the Following:a)Get the money needed to buy condoms b)Walk into a store\&buy condoms c)Find a place to get condoms for free(Cronbach alpha-0.72)||15|3|
72335488|NCT02226198|144193866|SUPERIORITY_OR_OTHER||Relative difference in geometric LSM|-22.3||||0.005|TWO_SIDED|95.0|-33.5|-9.1||statistical significance set at 0.05|Mixed Models Analysis||Rosuvastatin treatment gives on average a 22.3% lower geometric LS mean than placebo.|cross-over, null hypothesis is no difference between ros and plc. Powered for 90% detection of 15% delta||-9.1|-33.5|0.005
72335489|NCT02226198|144193867|SUPERIORITY_OR_OTHER||Relative difference in geometric LSM|-22.3||||0.005|TWO_SIDED|95.0|-33.5|-9.1||statistical significance set at 0.05|Mixed Models Analysis||Rosuvastatin treatment gives on average a 22.3% lower geometric LS mean than placebo.|cross-over, null hypothesis is no difference between ros and plc. Powered for 90% detection of 15% delta||-9.1|-33.5|0.005
72335490|NCT02226198|144193868|SUPERIORITY_OR_OTHER||Relative difference in geometric LSM|-20.1||||0.003|TWO_SIDED|95.0|-29.7|-9.1||statistical significance set at 0.05|Mixed Models Analysis|||cross-over, null hypothesis is no difference between ros and plc.||-9.1|-29.7|0.003
72335491|NCT02226198|144193869|SUPERIORITY_OR_OTHER||Relative difference in geometric LSM|-20.1||||0.003|TWO_SIDED|95.0|-29.7|-9.1||statistical significance set at 0.05|Mixed Models Analysis|||cross-over, null hypothesis is no difference between ros and plc.||-9.1|-29.7|0.003
72335492|NCT02226198|144193870|SUPERIORITY_OR_OTHER||Relative difference in geometric LSM|-22.9||||0.003|TWO_SIDED|95.0|-33.7|-10.3||statistical significance set at 0.05|Mixed Models Analysis|||cross-over, null hypothesis is no difference between ros and plc.||-10.3|-33.7|0.003
72335493|NCT02226198|144193871|SUPERIORITY_OR_OTHER||Relative difference in geometric LSM|-22.9||||0.003|TWO_SIDED|95.0|-33.7|-10.3||statistical significance set at 0.05|Mixed Models Analysis|||cross-over, null hypothesis is no difference between ros and plc.||-10.3|-33.7|0.003
72335494|NCT02226198|144193872|SUPERIORITY_OR_OTHER||Relative difference in geometric LSM|-17.1||||0.024|TWO_SIDED|95.0|-29.2|-2.9||statistical significance set at 0.05|Mixed Models Analysis|||cross-over, null hypothesis is no difference between ros and plc.||-2.9|-29.2|0.024
72335495|NCT02226198|144193873|SUPERIORITY_OR_OTHER||Relative difference in geometric LSM|-17.1||||0.024|TWO_SIDED|95.0|-29.2|-2.9||statistical significance set at 0.05|Mixed Models Analysis|||cross-over, null hypothesis is no difference between ros and plc.||-2.9|-29.2|0.024
72335496|NCT02226198|144193874|SUPERIORITY_OR_OTHER||Relative difference in geometric LSM|7.4||||0.314|TWO_SIDED|95.0|-7.4|24.5||statistical significance set at 0.05|Mixed Models Analysis|||cross-over, null hypothesis is no difference between ros and plc.||24.5|-7.4|0.314
72335497|NCT02226198|144193875|SUPERIORITY_OR_OTHER||Relative difference in geometric LSM|7.4||||0.314|TWO_SIDED|95.0|-7.4|24.5||statistical significance set at 0.05|Mixed Models Analysis|||cross-over, null hypothesis is no difference between ros and plc.||24.5|-7.4|0.314
72335498|NCT02226198|144193876|SUPERIORITY_OR_OTHER||Relative difference in geometric LSM|-26.3||||0.08|TWO_SIDED|95.0|-48.7|6.0||statistical significance set at 0.05|Mixed Models Analysis|||cross-over, null hypothesis is no difference between ros and plc.||6.0|-48.7|0.080
72335499|NCT02226198|144193877|SUPERIORITY_OR_OTHER||Relative difference in geometric LSM|-26.3||||0.08|TWO_SIDED|95.0|-48.7|6.0||statistical significance set at 0.05|Mixed Models Analysis|||cross-over, null hypothesis is no difference between ros and plc.||6.0|-48.7|0.080
72335500|NCT02226198|144193888|SUPERIORITY_OR_OTHER||Relative difference in geometric LSM|-30.4||||0.004|TWO_SIDED|95.0|-44.2|-13.3||statistical significance set at 0.05|Mixed Models Analysis|||cross-over, null hypothesis is no difference between ros and plc.||-13.3|-44.2|0.004
72335501|NCT02226198|144193889|SUPERIORITY_OR_OTHER||Relative difference in geometric LSM|-30.4||||0.004|TWO_SIDED|95.0|-44.2|-13.3||statistical significance set at 0.05|Mixed Models Analysis|||cross-over, null hypothesis is no difference between ros and plc.||-13.3|-44.2|0.004
72335502|NCT02226198|144193890|SUPERIORITY_OR_OTHER||Relative difference in geometric LSM|-27.6||||0.006|TWO_SIDED|95.0|-41.2|-11.0||statistical significance set at 0.05|Mixed Models Analysis|||cross-over, null hypothesis is no difference between ros and plc.||-11.0|-41.2|0.006
72335503|NCT02226198|144193891|SUPERIORITY_OR_OTHER||Relative difference in geometric LSM|-25.6||||0.005|TWO_SIDED|95.0|-38.1|-10.5||statistical significance set at 0.05|Mixed Models Analysis|||cross-over, null hypothesis is no difference between ros and plc.||-10.5|-38.1|0.005
72335504|NCT02226198|144193892|SUPERIORITY_OR_OTHER||Relative difference in geometric LSM|-28.2||||0.005|TWO_SIDED|95.0|-41.7|-11.4||statistical significance set at 0.05|Mixed Models Analysis|||cross-over, null hypothesis is no difference between ros and plc.||-11.4|-41.7|0.005
72335505|NCT02226198|144193893|SUPERIORITY_OR_OTHER||Relative difference in geometric LSM|-20.4||||0.013|TWO_SIDED|95.0|-32.8|-5.6||statistical significance set at 0.05|Mixed Models Analysis|||cross-over, null hypothesis is no difference between ros and plc.||-5.6|-32.8|0.013
72335506|NCT03895632|144193898|OTHER|A linear mixed-effects model was fit to assess the association between α (the slope of the Power Spectral Density (PSD) plot) and signal segment.|||||<|0.0001||||||p-value obtained form the Wald statistics of the linear mixed-effects model. The threshold for statistical signifiance was p=0.01.|Linear mixed-effects model|||The null hypothesis was that α (the slope of the Power Spectral Density (PSD) plot) is not related to signal segment (off-, approaching- and on-target).||||<0.0001
72335507|NCT01288612|144193910|SUPERIORITY_OR_OTHER|||||||0.25|TWO_SIDED||||||Chi-squared|||||||0.25
72335508|NCT01288612|144193910|SUPERIORITY_OR_OTHER|||||||0.42|TWO_SIDED||||||Chi-squared|||||||0.42
72335509|NCT01288612|144193910|SUPERIORITY_OR_OTHER|||||||0.27|TWO_SIDED||||||Chi-squared|||||||0.27
72335510|NCT01288612|144193910|SUPERIORITY_OR_OTHER|||||||0.82|TWO_SIDED||||||Chi-squared|||||||0.82
72335511|NCT01288612|144193911|SUPERIORITY_OR_OTHER|||||||0.06|TWO_SIDED||||||Kruskal-Wallis|||||||0.06
72335512|NCT01288612|144193912|SUPERIORITY_OR_OTHER|||||||0.08|TWO_SIDED||||||Fisher Exact|||||||0.08
72335513|NCT01288612|144193913|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED||||||Kruskal-Wallis|||||||0.001
72335514|NCT01288612|144193914|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Kruskal-Wallis|||||||<0.001
72335515|NCT01288612|144193915|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Kruskal-Wallis|||||||<0.001
72335516|NCT01288612|144193916|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Kruskal-Wallis|||Comparison between the arms for pain scale||||<0.001
72335517|NCT01288612|144193916|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Kruskal-Wallis|||Comparison between the arms for choking scale||||<0.001
72335518|NCT01288612|144193916|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Kruskal-Wallis|||Comparison between the arms for gagging scale||||<0.001
72335519|NCT01288612|144193916|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Kruskal-Wallis|||Comparison between the arms for anxiety scale||||<0.001
72335520|NCT01288612|144193916|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Kruskal-Wallis|||Comparison between arms for overall tolerance scale||||<0.001
72335521|NCT01288612|144193917|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED||||||Kruskal-Wallis|||||||0.001
72335522|NCT01468207|144193960|SUPERIORITY_OR_OTHER_LEGACY||Adjusted mean difference|15.9|||=|0.003|TWO_SIDED|95.0|5.3|26.5||P-value adjusted for baseline Hurley Stage.|Cochran-Mantel-Haenszel|||||26.5|5.3|=0.003
72335523|NCT01468207|144193960|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|14.8|||=|0.048|TWO_SIDED|95.0|0.3|29.3|||Chi-squared|||||29.3|0.3|=0.048
72335524|NCT01468207|144193960|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|17.1|||=|0.027|TWO_SIDED|95.0|2.2|32.1|||Chi-squared|||||32.1|2.2|=0.027
72426193|NCT00405353|144364235|OTHER||||||<|0.05|||||||Mixed Models Analysis|Linear regressions were used to determine slopes of brain volume changes. Statistical software package SAS was used to perform the analysis.||Percent change in brain volume against time scatter plot with a Loess regression curve was produced and a first-degree spline model was developed. This model fitted line pieces for pre-treatment and early treatment periods (month -6 to month 3) and treatment response period (months 3-12), and these pieces were joined together to achieve continuity. Slopes of these lines were estimated and compared. A random intercept was set in the model to allow the difference among subjects.||||<0.05
72426194|NCT02906683|144364241|SUPERIORITY||Mean Difference (Final Values)|-6.7|STANDARD_ERROR_OF_MEAN|6.8||0.329|TWO_SIDED|95.0|-20.1|6.7|||t-test, 2 sided|||TAS-303 3 mg group vs. Placebo group for the mean percentage changes in IEF per 24 hours from baseline to Week 8||6.7|-20.1|0.329
72426195|NCT02906683|144364241|SUPERIORITY||Mean Difference (Final Values)|-7.3|STANDARD_ERROR_OF_MEAN|6.84||0.285|TWO_SIDED|95.0|-20.9|6.2|||t-test, 2 sided|||TAS-303 6 mg group vs. Placebo group for the mean percentage changes in IEF per 24 hours from baseline to Week 8||6.2|-20.9|0.285
72426196|NCT02906683|144364243|SUPERIORITY||Mean Difference (Final Values)|-11.3|STANDARD_ERROR_OF_MEAN|6.48||0.082|TWO_SIDED|95.0|-24.1|1.5|||t-test, 2 sided|||TAS-303 3 mg group vs. Placebo group for the mean percentage changes in IEF per 24 hours from baseline to Week 4||1.5|-24.1|0.082
72426197|NCT02906683|144364243|SUPERIORITY||Mean Difference (Final Values)|-12.1|STANDARD_ERROR_OF_MEAN|6.34||0.057|TWO_SIDED|95.0|-24.7|0.4|||t-test, 2 sided|||TAS-303 6 mg group vs. Placebo group for the mean percentage changes in IEF per 24 hours from baseline to Week 4||0.4|-24.7|0.057
72426198|NCT02906683|144364245|SUPERIORITY||Mean Difference (Final Values)|-17.6|STANDARD_ERROR_OF_MEAN|7.38||0.019|TWO_SIDED|95.0|-32.2|-3.0|||t-test, 2 sided|||TAS-303 3 mg group vs. Placebo group for the mean percentage changes in IEF per 24 hours from baseline to Week 4||-3.0|-32.2|0.019
72426199|NCT02906683|144364245|SUPERIORITY||Mean Difference (Final Values)|-16.9|STANDARD_ERROR_OF_MEAN|7.36||0.023|TWO_SIDED|95.0|-31.5|-2.3|||t-test, 2 sided|||TAS-303 6 mg group vs. Placebo group for the mean percentage changes in IEF per 24 hours from baseline to Week 4||-2.3|-31.5|0.023
72426200|NCT02906683|144364247|SUPERIORITY||Mean Difference (Final Values)|-11.4|STANDARD_ERROR_OF_MEAN|7.36||0.125|TWO_SIDED|95.0|-25.9|3.2|||t-test, 2 sided|||TAS-303 3 mg group vs. Placebo group for the mean percentage changes in IEF per 24 hours from baseline to Week 8||3.2|-25.9|0.125
72426201|NCT02906683|144364247|SUPERIORITY||Mean Difference (Final Values)|-9.6|STANDARD_ERROR_OF_MEAN|7.8||0.221|TWO_SIDED|95.0|-25.1|5.9|||t-test, 2 sided|||TAS-303 6 mg group vs. Placebo group for the mean percentage changes in IEF per 24 hours from baseline to Week 8||5.9|-25.1|0.221
72426202|NCT00437125|144364261|SUPERIORITY_OR_OTHER||Percentage|8.6|||||ONE_SIDED|95.0||13.3||||||||13.3||
72426203|NCT00437125|144364262|SUPERIORITY_OR_OTHER|||||||0.5553||95.0||||p-value is for total UDPRS score - change. A priori threshold for p-values was 0.05.|t-test, 2 sided|||Tested was the null hypothesis that there would be no change on the total UDPRS score from baseline to 12-week endpoint.||||0.5553
72426204|NCT00437125|144364263|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||p-value is for psychic subscale. A priori threshold for p-values was 0.05.|t-test, 2 sided|||Tested was the null hypothesis that there would be no change on the total psychic subscale score from baseline to 12-week endpoint.||||<0.0001
72426205|NCT00437125|144364263|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||p-value is for neurological subscale. A priori threshold for p-values was 0.05.|t-test, 2 sided|||Tested was the null hypothesis that there would be no change on the total neurological subscale score from baseline to 12-week endpoint.||||<0.0001
72426206|NCT00437125|144364263|SUPERIORITY_OR_OTHER|||||||0.0014||95.0||||p-value is for autonomic subscale. A priori threshold for p-values was 0.05.|t-test, 2 sided|||Tested was the null hypothesis that there would be no change on the total autonomic subscale score from baseline to 12-week endpoint.||||0.0014
72426207|NCT00437125|144364263|SUPERIORITY_OR_OTHER|||||||0.5586||95.0||||p-value is for other subscale. A priori threshold for p-values was 0.05.|t-test, 2 sided|||Tested was the null hypothesis that there would be no change on the total other subscale score from baseline to 12-week endpoint.||||0.5586
72426208|NCT00437125|144364263|SUPERIORITY_OR_OTHER|||||||0.0848||95.0||||p-value is for global assessment by paticipant. A priori threshold for p-values was 0.05.|t-test, 2 sided|||Tested was the null hypothesis that there would be no change on the global assessment by paticipant subscale score from baseline to 12-week endpoint.||||0.0848
72426209|NCT00437125|144364263|SUPERIORITY_OR_OTHER|||||||0.0263||95.0||||p-value is for global assessment by doctor. A priori threshold for p-values was 0.05.|t-test, 2 sided|||Tested was the null hypothesis that there would be no change on the global assessment by doctor subscale score from baseline to 12-week endpoint.||||0.0263
72426210|NCT00437125|144364264|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||p-value is for 4 weeks change. A priori threshold for p-values was 0.05.|t-test, 2 sided|||Tested was the null hypothesis that there would be no change on the Pittsburgh Sleep Quality Index from baseline to 4-week endpoint.||||<0.0001
72426211|NCT00437125|144364264|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||p-value is for 8 weeks change. A priori threshold for p-values was 0.05.|t-test, 2 sided|||Tested was the null hypothesis that there would be no change on the Pittsburgh Sleep Quality Index from baseline to 8-week endpoint.||||<0.0001
72426212|NCT00437125|144364264|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||p-value is for 12 weeks change. A priori threshold for p-values was 0.05.|t-test, 2 sided|||Tested was the null hypothesis that there would be no change on the Pittsburgh Sleep Quality Index from baseline to 12-week endpoint.||||<0.0001
72426213|NCT00437125|144364265|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||p-value is for the HAMD-17 total score. A priori threshold for p-values was 0.05.|t-test, 2 sided|||Tested was the null hypothesis that there would be no change on the HAMD-17 total score from baseline to 12-week endpoint.||||<0.0001
72426214|NCT00437125|144364266|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||p-value is for Clinical Global Impression-Severity scale - change. A priori threshold for p-values was 0.05.|t-test, 2 sided|||Tested was the null hypothesis that there would be no change on the Clinical Global Impression-Severity scale score from baseline to end of week 12 of treatment.||||<0.0001
72426215|NCT00437125|144364268|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||p-value is for BDI score - change. A priori threshold for p-values was 0.05.|t-test, 2 sided|||Tested was the null hypothesis that there would be no difference between baseline and post-baseline in BDI scores||||<0.0001
72426216|NCT00437125|144364269|SUPERIORITY_OR_OTHER|||||||0.0027||95.0||||p-value is for VAS overall pain score - change. A priori threshold for p-values was 0.05.|t-test, 2 sided|||Tested was the null hypothesis that there would be no change from baseline to 12 weeks in VAS overall pain scores.||||0.0027
72426217|NCT00437125|144364269|SUPERIORITY_OR_OTHER|||||||0.0002||95.0||||p-value is for VAS Headaches score - change. A priori threshold for p-values was 0.05.|t-test, 2 sided|||Tested was the null hypothesis that there would be no change from baseline to 12 weeks in VAS headaches scores.||||0.0002
72426218|NCT00437125|144364269|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||p-value is for VAS back ache score - change. A priori threshold for p-values was 0.05.|t-test, 2 sided|||Tested was the null hypothesis that there would be no change from baseline to 12 weeks in VAS back ache scores.||||<0.0001
72426219|NCT00437125|144364269|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||p-value is for VAS shoulder pain score - change. A priori threshold for p-values was 0.05.|t-test, 2 sided|||Tested was the null hypothesis that there would be no change from baseline to 12 weeks in VAS shoulder pain score.||||<0.0001
72426220|NCT00437125|144364269|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||p-value is for VAS interference score - change. A priori threshold for p-values was 0.05.|t-test, 2 sided|||Tested was the null hypothesis that there would be no change from baseline to 12 weeks in VAS interference score.||||<0.0001
72426221|NCT00437125|144364269|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||p-value is for VAS pain while awake score - change. A priori threshold for p-values was 0.05.|t-test, 2 sided|||Tested was the null hypothesis that there would be no change from baseline to 12 weeks in VAS pain while awake score.||||<0.0001
72426222|NCT00437125|144364270|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||p-value is for PDQ-39 total score - change. A priori threshold for p-values was 0.05.|t-test, 2 sided|||Tested was the null hypothesis that there would be no change from baseline to 12 weeks in PDQ-39 total score.||||<0.0001
72426223|NCT02248961|144364279|OTHER|It was calculated that at least 140 patients (70 patients per group) must be enrolled into the study to achieve 80% power. With regard to 20% of patients withdrawn prematurely or data not suitable for analysis, it was necessary to include at least 176 patients (88 per group) into the study.|Mean Difference (Final Values)|-0.18|STANDARD_ERROR_OF_MEAN|1.0|=|0.39|ONE_SIDED|95.0||1.47|||Mixed Models Analysis|||"The null hypothesis (H0) is that there is a decrease in SBP on the background treatment with Kanarb (fimasartan), that is at least 5.5 mmHg lower compared to Cozaar® (losartan).~Test of the hypotheses was performed using mixed linear models, where the site effect was considered a random effect, and the treatment group effect was considered a fixed effect. Baseline SBP on the study arm was included into the model as a covariate (a fixed effect) in all cases."||1.47||=0.390
72426224|NCT02248961|144364280|OTHER||||||=|0.018|||||||Mixed Models Analysis|The investigational site was included as random effect. The baseline levels of SBP and the treatment group were included as fixed effects.||||||=0.018
72426225|NCT02248961|144364281|OTHER||||||=|0.579|||||||Mixed Models Analysis|The investigational site was included as random effect. The baseline levels of SBP and the treatment group were included as fixed effects.||||||=0.579
72426226|NCT02248961|144364282|OTHER||||||=|0.466|||||||Mixed Models Analysis|The investigational site was included as random effect. The baseline levels of SBP and the treatment group were included as fixed effects.||||||=0.466
72426227|NCT02248961|144364283|OTHER||||||=|0.118|||||||Mixed Models Analysis|The investigational site was included as random effect. The baseline levels of SBP and the treatment group were included as fixed effects.||||||=0.118
72426228|NCT02248961|144364284|OTHER||||||=|0.662|||||||Mixed Models Analysis|The investigational site was included as random effect. The baseline levels of SBP and the treatment group were included as fixed effects.||||||=0.662
72426229|NCT02248961|144364285|OTHER||||||=|0.143|||||||Mantel Haenszel|||||||=0.143
72426230|NCT00871351|144364313|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-10.6|||<|0.0001|TWO_SIDED|95.0|-15.4|-5.8|||Hochberg's method|||||-5.8|-15.4|<0.0001
72426231|NCT00871351|144364313|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-26.5|||<|0.0001|TWO_SIDED|95.0|-31.8|-21.2|||Hochberg's method|||||-21.2|-31.8|<0.0001
72426232|NCT00871351|144364314|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0003||95.0|||||Hochberg's method|||||||0.0003
72426233|NCT00871351|144364314|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||Hochberg's method|||||||<0.0001
72335525|NCT01468207|144193961|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.3|||=|0.961|TWO_SIDED|95.0|-13.4|14.1|||Chi-squared|||Secondary end points 1 (AN 0/1/2 counts), 2 (NRS30), and 3 (modified Sartorius score) were ranked analyses.||14.1|-13.4|=0.961
72426234|NCT02791490|144364322|SUPERIORITY||Difference in Least Squares Means|-0.41|||<|0.001|TWO_SIDED|95.0|-0.59|-0.23|||Longitudinal Data Analysis|||||-0.23|-0.59|<0.001
72335526|NCT01468207|144193962|SUPERIORITY_OR_OTHER_LEGACY||Adjusted mean difference|2.8|||=|0.628|TWO_SIDED|95.0|-8.6|14.2||P-value adjusted for baseline Hurley Stage.|Cochran-Mantel-Haenszel|||Secondary end points 1 (AN 0/1/2 counts), 2 (NRS30), and 3 (modified Sartorius score) were ranked analyses.||14.2|-8.6|=0.628
72426235|NCT02791490|144364323|OTHER|95% CI|Difference in % vs Placebo|-1.7|||||TWO_SIDED|95.0|-10.8|7.4|||Miettinen and Nurminen method|||||7.4|-10.8|
72426236|NCT02791490|144364325|SUPERIORITY||Relative Risk|1.7||||0.002|TWO_SIDED|95.0|1.2|2.5|||Miettinen and Nurminen method|||||2.5|1.2|0.002
72426237|NCT02791490|144364326|SUPERIORITY||Difference in Least Squares Means|-12.4||||0.002|TWO_SIDED|95.0|-20.2|-4.6|||Longitudinal Data Analysis|||||-4.6|-20.2|0.002
72426238|NCT01984424|144364329|SUPERIORITY|Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|LS Mean Treatment Difference|-37.79|STANDARD_ERROR_OF_MEAN|2.29|<|0.0001|TWO_SIDED|95.0|-42.31|-33.28|||Repeated Measures Model|Model includes treatment group, stratification factor (screening LDL-C), scheduled visit and interaction of treatment with scheduled visit.||The null hypothesis was that there was no mean difference in the percent change from baseline at week 24 of part B or in the mean percent change from baseline at weeks 22 and 24 of part B in LDL-C between evolocumab 420 mg and ezetimibe, and the alternative hypothesis was that a mean difference did exist.||-33.28|-42.31|<0.0001
72426239|NCT01984424|144364330|SUPERIORITY||LS Mean Treatment Difference|-36.07|STANDARD_ERROR_OF_MEAN|2.53|<|0.0001|TWO_SIDED|95.0|-41.07|-31.08||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated Measures Model|Model includes treatment group, stratification factor (screening LDL-C), scheduled visit and interaction of treatment with scheduled visit.||The null hypothesis was that there was no mean difference in the percent change from baseline at week 24 of part B or in the mean percent change from baseline at weeks 22 and 24 of part B in LDL-C between evolocumab 420 mg and ezetimibe, and the alternative hypothesis was that a mean difference did exist.||-31.08|-41.07|<0.0001
72426240|NCT01984424|144364331|SUPERIORITY||LS Mean Treatment Difference|-75.8|STANDARD_ERROR_OF_MEAN|4.5|<|0.0001|TWO_SIDED|95.0|-84.7|-67.0||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated Measures Model|Model includes treatment group, stratification factor (screening LDL-C), scheduled visit and interaction of treatment with scheduled visit.||||-67.0|-84.7|<0.0001
72335527|NCT01468207|144193963|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-8.7|||=|0.124|TWO_SIDED|95.0|-19.7|2.4|||ANCOVA|P-value calculated from ANCOVA with stratum, baseline, and treatment as covariates.||Secondary end points 1 (AN 0/1/2 counts), 2 (NRS30), and 3 (modified Sartorius score) were ranked analyses.||2.4|-19.7|=0.124
72335528|NCT03002818|144193986|SUPERIORITY||mean change|-108266.0||||0.091|TWO_SIDED|95.0|-235037.0|18504.0|||one-sample t-test|||sdITT (n=26): Change at Day 168 minus Baseline||18504|-235037|0.091
72335529|NCT03002818|144193986|SUPERIORITY||mean change|-98373.0||||0.152|TWO_SIDED|95.0|-235667.0|38921.0|||one-sample t-test|||mITT (n=24): Change at Day 168 minus Baseline||38921|-235667|0.152
72335530|NCT03002818|144193986|SUPERIORITY|||||||0.091|||||||paired t-test|||sdITT (n=26): Baseline vs. Day 168||||0.091
72335531|NCT03002818|144193986|SUPERIORITY|||||||0.152|||||||paired t-test|||mITT (n=24): Baseline vs. Day 168||||0.152
72335532|NCT03002818|144193987|SUPERIORITY|||||||0.461|||||||paired t-test|||sdITT (n=34): Baseline vs. Day 28||||0.461
72335533|NCT03002818|144193987|SUPERIORITY|||||||0.63|||||||paired t-test|||mITT (n=24): Baseline vs. Day 28||||0.630
72335534|NCT03002818|144193987|SUPERIORITY|||||||0.855|||||||paired t-test|||sdITT (n=32): Baseline vs. Day 84||||0.855
72335535|NCT03002818|144193987|SUPERIORITY|||||||0.75|||||||paired t-test|||mITT (n=24): Baseline vs. Day 84||||0.750
72335536|NCT03002818|144193988|SUPERIORITY||mean change|2.6|||||TWO_SIDED|95.0|2.063|3.137||||||sdITT: mean change Baseline minus Day 168||3.137|2.063|
72335537|NCT03002818|144193988|SUPERIORITY||mean change|2.82|||||TWO_SIDED|95.0|2.212|3.428||||||mITT: mean change Baseline minus Day 168||3.428|2.212|
72335538|NCT03002818|144193988|SUPERIORITY||||||<|0.001|||||||Paired Wilcoxon Test|||sdITT (n=37): Baseline vs. Day 168||||<0.001
72335539|NCT03002818|144193988|SUPERIORITY||||||<|0.001|||||||Paired Wilcoxon Test|||mITT (n=24): Baseline vs. Day 168||||<0.001
72335540|NCT03002818|144193988|SUPERIORITY||||||<|0.001|||||||Paired Wilcoxon Test|||sdITT (n=35): Baseline vs. Day 28||||<0.001
72335541|NCT03002818|144193988|SUPERIORITY||||||<|0.001|||||||Paired Wilcoxon Test|||mITT (n=22): Baseline vs. Day 28||||<0.001
72335542|NCT03002818|144193988|SUPERIORITY||||||<|0.001|||||||Paired Wilcoxon Test|||sdITT (n=36): Baseline vs. Day 84||||<0.001
72426241|NCT01984424|144364332|SUPERIORITY||LS Mean Treatment Difference|-71.7|STANDARD_ERROR_OF_MEAN|4.8|<|0.0001|TWO_SIDED|95.0|-81.3|-62.2||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated Measures Model|Model includes treatment group, stratification factor (screening LDL-C), scheduled visit and interaction of treatment with scheduled visit.||||-62.2|-81.3|<0.0001
72335543|NCT03002818|144193988|SUPERIORITY||||||<|0.001|||||||Paired Wilcoxon Test|||mITT (n=23): Baseline vs. Day 84||||<0.001
72335544|NCT03002818|144193989|SUPERIORITY||mean change|0.61|||||TWO_SIDED|95.0|-0.651|1.871||||||sdITT: mean change Baseline minus Day 168||1.871|-0.651|
72335545|NCT03002818|144193989|SUPERIORITY||mean change|0.74|||||TWO_SIDED|95.0|-0.608|2.088||||||mITT: mean change Baseline minus Day 168||2.088|-0.608|
72335546|NCT03002818|144193989|SUPERIORITY|||||||0.381|||||||Paired Wilcoxon Test|||sdITT (n=37): Baseline vs. Day 168||||0.381
72335547|NCT03002818|144193989|SUPERIORITY|||||||0.304|||||||Paired Wilcoxon Test|||mITT (n=24): Baseline vs. Day 168||||0.304
72335548|NCT03002818|144193989|SUPERIORITY|||||||0.014|||||||Paired Wilcoxon Test|||sdITT (n=35): Baseline vs. Day 28||||0.014
72335549|NCT03002818|144193989|SUPERIORITY|||||||0.278|||||||Paired Wilcoxon Test|||mITT (n=22): Baseline vs. Day 28||||0.278
72335550|NCT03002818|144193989|SUPERIORITY|||||||0.881|||||||Paired Wilcoxon Test|||sdITT (n=36): Baseline vs. Day 84||||0.881
72335551|NCT03002818|144193989|SUPERIORITY|||||||0.775|||||||Paired Wilcoxon Test|||sdITT (n=23): Baseline vs. Day 84||||0.775
72335552|NCT00100230|144194002|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence analysis: standard power calculation of 20%; used 2-sided t-test||||||0.3|TWO_SIDED|||||Threshold for significance: p\<0.05|Mixed Models Analysis|||||||0.30
72335553|NCT00100230|144194003|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence analysis: standard power calculation of 20%; used 2-sided t-test||||||0.27|TWO_SIDED|||||Threshold for significance: p\<0.05|Mixed Models Analysis|||||||0.27
72335554|NCT00100230|144194003|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence analysis: standard power calculation of 20%; used 2-sided t-test||||||0.27|TWO_SIDED||||||Mixed Models Analysis|||||||0.27
72335555|NCT00100230|144194004|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence analysis: standard power calculation of 20%; used 2-sided t-test||||||8e-06|TWO_SIDED|||||Threshold for significance: p\<0.05|Mixed Models Analysis|||||||0.000008
72335556|NCT03392883|144194050|OTHER|Paired version (T-test for paired sample, Friedman and McNemar tests) was used for contrasting the equality among the variables at different moments of time. In order to adjust our results by potential confounders, ANCOVA analyses was performed. Symmetric 95% confidence intervals will be provided for relevant parameters. All p-values were referred to two-sided hypotheses. P-values below 0.05 were considered statistically significant.|||||<|0.001|TWO_SIDED|95.0||||p\<0.05 is the threshold for statistical significance.|t-test, 2 sided|||We analyzed changes over time for every subscale. This Statistical Analysis describes the Adoption subscale results.||||<0.001
72335557|NCT03392883|144194050|OTHER|||||||0.552||||||p\<0.05 is the threshold for statistical significance.|t-test, 2 sided|||We analyzed changes over time for every subscale in this instrument. This Statistical Analysis describes the Acceptability subscale results.||||0.552
72335558|NCT03392883|144194050|OTHER|||||||0.32||||||p\<0.05 is the threshold for statistical significance.|t-test, 2 sided|||We analyzed changes over time for every subscale in this instrument. This Statistical Analysis describes the Appropriateness subscale results.||||0.320
72335559|NCT03392883|144194050|OTHER|||||||0.879||||||p\<0.05 is the threshold for statistical significance.|t-test, 2 sided|||We analyzed changes over time for every subscale in this instrument. This Statistical Analysis describes the Feasibility subscale results.||||0.879
72426242|NCT01984424|144364333|SUPERIORITY||Treatment Difference|28.5|||<|0.0001|TWO_SIDED|95.0|19.1|36.7||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on Cochran-Mantel Haenszel test stratified by the stratification factor (screening LDL-C).||||36.7|19.1|<0.0001
72426243|NCT01984424|144364334|SUPERIORITY||Treatment Difference|27.4|||<|0.0001|TWO_SIDED|95.0|17.7|36.1||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on Cochran-Mantel Haenszel test stratified by the stratification factor (screening LDL-C).||||36.1|17.7|<0.0001
72426244|NCT01984424|144364335|SUPERIORITY||LS Mean Treatment Difference|-26.61|STANDARD_ERROR_OF_MEAN|1.69|<|0.0001|TWO_SIDED|95.0|-29.95|-23.27||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated Measures Model|Model includes treatment group, stratification factor (screening LDL-C), scheduled visit and interaction of treatment with scheduled visit.||||-23.27|-29.95|<0.0001
72426245|NCT01984424|144364336|SUPERIORITY||LS Mean Treatment Difference|-25.08|STANDARD_ERROR_OF_MEAN|1.82|<|0.0001|TWO_SIDED|95.0|-28.67|-21.48||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated Measures Model|Model includes treatment group, stratification factor (screening LDL-C), scheduled visit and interaction of treatment with scheduled visit.||||-21.48|-28.67|<0.0001
72426246|NCT01984424|144364337|SUPERIORITY||LS Mean Treatment Difference|-33.06|STANDARD_ERROR_OF_MEAN|2.06|<|0.0001|TWO_SIDED|95.0|-37.12|-28.99||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated Measures Model|Model includes treatment group, stratification factor (screening LDL-C), scheduled visit and interaction of treatment with scheduled visit.||||-28.99|-37.12|<0.0001
72426247|NCT01984424|144364338|SUPERIORITY||LS Mean Treatment Difference|-31.1|STANDARD_ERROR_OF_MEAN|2.2|<|0.0001|TWO_SIDED|95.0|-35.44|-16.76||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated Measures Model|Model includes treatment group, stratification factor (screening LDL-C), scheduled visit and interaction of treatment with scheduled visit.||||-16.76|-35.44|<0.0001
72426248|NCT01984424|144364339|SUPERIORITY||LS Mean Treatment Difference|-33.86|STANDARD_ERROR_OF_MEAN|2.17|<|0.0001|TWO_SIDED|95.0|-38.15|-29.58||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated Measures Model|Model includes treatment group, stratification factor (screening LDL-C), scheduled visit and interaction of treatment with scheduled visit.||||-29.58|-38.15|<0.0001
72426249|NCT01984424|144364340|SUPERIORITY||LS Mean Treatment Difference|-31.75|STANDARD_ERROR_OF_MEAN|2.33|<|0.0001|TWO_SIDED|95.0|-36.35|-27.16||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated Measures Model|Model includes treatment group, stratification factor (screening LDL-C), scheduled visit and interaction of treatment with scheduled visit.||||-27.16|-36.35|<0.0001
72426250|NCT01984424|144364341|SUPERIORITY||LS Mean Treatment Difference|-29.91|STANDARD_ERROR_OF_MEAN|2.1|<|0.0001|TWO_SIDED|95.0|-34.06|-25.77||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated Measures Model|Model includes treatment group, stratification factor (screening LDL-C), scheduled visit and interaction of treatment with scheduled visit.||||-25.77|-34.06|<0.0001
72426251|NCT01984424|144364342|SUPERIORITY||LS Mean Treatment Difference|-27.2|STANDARD_ERROR_OF_MEAN|2.22|<|0.0001|TWO_SIDED|95.0|-31.58|-22.82||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated Measures Model|Model includes treatment group, stratification factor (screening LDL-C), scheduled visit and interaction of treatment with scheduled visit.||||-22.82|-31.58|<0.0001
72426252|NCT01984424|144364343|SUPERIORITY||LS Mean Treatment Difference|-34.13|STANDARD_ERROR_OF_MEAN|2.26|<|0.0001|TWO_SIDED|95.0|-38.59|-29.67||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated Measures Model|Model includes treatment group, stratification factor (screening LDL-C), scheduled visit and interaction of treatment with scheduled visit.||||-29.67|-38.59|<0.0001
72426253|NCT01984424|144364344|SUPERIORITY||LS Mean Treatment Difference|-31.98|STANDARD_ERROR_OF_MEAN|2.36|<|0.0001|TWO_SIDED|95.0|-36.64|-27.32||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated Measures Model|Model includes treatment group, stratification factor (screening LDL-C), scheduled visit and interaction of treatment with scheduled visit.||||-27.32|-36.64|<0.0001
72426254|NCT01984424|144364345|SUPERIORITY||LS Mean Treatment Difference|-21.08|STANDARD_ERROR_OF_MEAN|3.33|<|0.0001|TWO_SIDED|95.0|-27.65|-14.51||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated Measures Model|Model includes treatment group, stratification factor (screening LDL-C), scheduled visit and interaction of treatment with scheduled visit.||||-14.51|-27.65|<0.0001
72426255|NCT01984424|144364346|SUPERIORITY||LS Mean Treatment Difference|-21.24|STANDARD_ERROR_OF_MEAN|3.64|<|0.0001|TWO_SIDED|95.0|-28.42|-14.05||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated Measures Model|Model includes treatment group, stratification factor (screening LDL-C), scheduled visit and interaction of treatment with scheduled visit.||||-14.05|-28.42|<0.0001
72426256|NCT01984424|144364347|SUPERIORITY||LS Mean Treatment Difference|-4.44|STANDARD_ERROR_OF_MEAN|4.72||0.37|TWO_SIDED|95.0|-13.74|4.87||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated Measures Model|Model includes treatment group, stratification factor (screening LDL-C), scheduled visit and interaction of treatment with scheduled visit.||||4.87|-13.74|0.37
72426257|NCT01984424|144364348|SUPERIORITY||LS Mean Treatment Difference|-1.82|STANDARD_ERROR_OF_MEAN|6.0||0.37|TWO_SIDED|95.0|-13.64|10.01||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated Measures Model|Model includes treatment group, stratification factor (screening LDL-C), scheduled visit and interaction of treatment with scheduled visit.||||10.01|-13.64|0.37
72426258|NCT01984424|144364349|SUPERIORITY||LS Mean Treatment Difference|6.18|STANDARD_ERROR_OF_MEAN|2.05||0.0083|TWO_SIDED|95.0|2.15|10.22||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated Measures Model|Model includes treatment group, stratification factor (screening LDL-C), scheduled visit and interaction of treatment with scheduled visit.||||10.22|2.15|0.0083
72335560|NCT03392883|144194050|OTHER|||||||0.242||||||p\<0.05 is the threshold for statistical significance.|t-test, 2 sided|||We analyzed changes over time for every subscale in this instrument. This Statistical Analysis describes the Reach/Access subscale results.||||0.242
72335561|NCT03392883|144194051|OTHER|||||||0.237||||||p\<0.05 is the threshold for statistical significance.|Regression, Linear|||We analyzed changes over time in this data for every sub-scale. This Statistical Analysis describes the Adoption subscale results.||||0.237
72335562|NCT03392883|144194051|OTHER|||||||0.492||||||p\<0.05 is the threshold for statistical significance.|Regression, Linear|||We analyzed changes over time in this data for every sub-scale. This Statistical Analysis describes the Accessibility subscale results.||||0.492
72335563|NCT03392883|144194051|OTHER|||||||0.285||||||p\<0.05 is the threshold for statistical significance.|Regression, Linear|||We analyzed changes over time in this data for every sub-scale. This Statistical Analysis describes the Appropriateness subscale results.||||0.285
72335564|NCT03392883|144194051|OTHER|||||||0.964||||||p\<0.05 is the threshold for statistical significance.|Regression, Linear|||We analyzed changes over time in this data for every sub-scale. This Statistical Analysis describes the Feasibility subscale results.||||0.964
72335565|NCT03392883|144194051|OTHER|||||||0.942||||||p\<0.05 is the threshold for statistical significance.|Regression, Linear|||We analyzed changes over time in this data for every sub-scale. This Statistical Analysis describes the Resources subscale results.||||0.942
72335566|NCT03392883|144194051|OTHER|||||||0.366||||||p\<0.05 is the threshold for statistical significance.|Regression, Linear|||We analyzed changes over time in this data for every sub-scale. This Statistical Analysis describes the Scope subscale results.||||0.366
72426259|NCT01984424|144364350|SUPERIORITY||LS Mean Treatment Difference|4.5|STANDARD_ERROR_OF_MEAN|2.27||0.0083|TWO_SIDED|95.0|0.02|8.98||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated Measures Model|Model includes treatment group, stratification factor (screening LDL-C), scheduled visit and interaction of treatment with scheduled visit.||||8.98|0.02|0.0083
72335567|NCT03392883|144194051|OTHER|||||||0.021||||||p\<0.05 is the threshold for statistical significance.|Regression, Linear|||We analyzed changes over time in this data for every sub-scale. This Statistical Analysis describes the Organizational Climate subscale results.||||0.021
72335568|NCT03392883|144194051|OTHER|||||||0.832||||||p\<0.05 is the threshold for statistical significance.|Regression, Linear|||We analyzed changes over time in this data for every sub-scale. This Statistical Analysis describes the Leadership in Implementing subscale results.||||0.832
72335569|NCT03392883|144194051|OTHER|||||||0.827||||||p\<0.05 is the threshold for statistical significance.|Regression, Linear|||We analyzed changes over time in this data for every sub-scale. This Statistical Analysis describes the General Leadership Skills subscale results.||||0.827
72335570|NCT03392883|144194052|OTHER|||||||0.118||||||p\<0.05 is the threshold for statistical significance.|Regression, Linear|||We analyzed changes over time in this data for every sub-scale. This Statistical Analysis describes the Adoption subscale results.||||0.118
72335571|NCT03392883|144194052|OTHER|||||||0.896||||||p\<0.05 is the threshold for statistical significance.|Regression, Linear|||We analyzed changes over time in this data for every sub-scale. This Statistical Analysis describes the Accessibility subscale results.||||0.896
72335572|NCT03392883|144194052|OTHER|||||||0.739||||||p\<0.05 is the threshold for statistical significance.|Regression, Linear|||We analyzed changes over time in this data for every sub-scale. This Statistical Analysis describes the Appropriateness subscale results.||||0.739
72335573|NCT03392883|144194052|OTHER|||||||0.724||||||p\<0.05 is the threshold for statistical significance.|Regression, Linear|||We analyzed changes over time in this data for every sub-scale. This Statistical Analysis describes the Feasibility subscale results.||||0.724
72335574|NCT03392883|144194052|OTHER|||||||0.301||||||p\<0.05 is the threshold for statistical significance.|Regression, Linear|||We analyzed changes over time in this data for every sub-scale. This Statistical Analysis describes the Adoption subscale results.||||0.301
72335575|NCT03392883|144194052|OTHER|||||||0.034||||||p\<0.05 is the threshold for statistical significance.|Regression, Linear|||We analyzed changes over time in this data for every sub-scale. This Statistical Analysis describes the Organizational Climate subscale results.||||0.034
72426260|NCT01984424|144364351|SUPERIORITY||LS Mean Treatment Difference|-4.65|STANDARD_ERROR_OF_MEAN|3.85||0.37|TWO_SIDED|95.0|-12.25|2.94||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated Measures Model|Model includes treatment group, stratification factor (screening LDL-C), scheduled visit and interaction of treatment with scheduled visit.||||2.94|-12.25|0.37
72426261|NCT01984424|144364352|SUPERIORITY||LS Mean Treatment Difference|-1.23|STANDARD_ERROR_OF_MEAN|4.67||0.37|TWO_SIDED|95.0|-10.45|7.98||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated Measures Model|Model includes treatment group, stratification factor (screening LDL-C), scheduled visit and interaction of treatment with scheduled visit.||||7.98|-10.45|0.37
72426262|NCT00077636|144364355|NON_INFERIORITY_OR_EQUIVALENCE|These results indicated that sustained virological response achieved with 16 weeks of treatment was not equivalent to that achieved with 24 week of treatment.|Odds Ratio (OR)|0.59|||<|0.0001|TWO_SIDED|95.0|0.46|0.76|||Cochran-Mantel-Haenszel|stratified by country and HCV genotype.||||0.76|0.46|<.0001
72335576|NCT03392883|144194052|OTHER|||||||0.015||||||p\<0.05 is the threshold for statistical significance.|Regression, Linear|||We analyzed changes over time in this data for every sub-scale. This Statistical Analysis describes the Leadership in Implementing subscale results.||||0.015
72335577|NCT03392883|144194052|OTHER|||||||0.081||||||p\<0.05 is the threshold for statistical significance.|Regression, Linear|||We analyzed changes over time in this data for every sub-scale. This Statistical Analysis describes the General Leadership Skills subscale results.||||0.081
72335578|NCT03392883|144194052|OTHER|||||||0.79||||||p\<0.05 is the threshold for statistical significance.|Regression, Linear|||We analyzed changes over time in this data for every sub-scale. This Statistical Analysis describes the Knowledge subscale results.||||0.790
72335579|NCT03392883|144194053|OTHER|||||||0.023||||||p\<0.05 is the threshold for statistical significance.|Regression, Linear|||We analyzed changes in the overall scores over time.||||0.023
72335580|NCT03392883|144194054|OTHER|||||||0.589||||||p\<0.05 is the threshold for statistical significance.|Regression, Linear|||We analyzed changes in the overall scores over time in this data.||||0.589
72335581|NCT03392883|144194055|OTHER||Mean Difference (Net)|-6.65|||||TWO_SIDED|||||||||We analyzed changes over time by calculating the mean difference of the scores at baseline assessment and at 12-month follow-up assessment.||||
72335582|NCT03392883|144194056|OTHER||Mean Difference (Net)|-4.48|||||TWO_SIDED|||||||||We analyzed changes over time by calculating the mean difference of the total scores (sum of 12 items) at baseline assessment and at 12-month follow-up assessment.||||
72335583|NCT03392883|144194057|OTHER||Mean Difference (Net)|-5.77|||||TWO_SIDED|||||||||We analyzed changes over time by calculating the mean difference of the scores at baseline assessment and at 12-month follow-up assessment.||||
72335584|NCT03392883|144194058|OTHER||Mean Difference (Net)|-2.59|||||TWO_SIDED|||||||||We analyzed changes over time by calculating the mean difference of the number of standard drinks per week at baseline assessment and at 12-month follow-up assessment.||||
72335585|NCT00322023|144194078|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED|95.0|||||t-test, 2 sided|These are paired t test baseline vs final for the 30 mg/kg dose||||||<0.0001
72335586|NCT00322023|144194078|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|These are paired t test baseline vs final for the 60 mg/kg dose||||||<0.05
72335587|NCT00322023|144194078|SUPERIORITY|These are paired t test baseline vs final for the 120 mg/kg dose|||||<|0.01|||||||t-test, 2 sided|||||||<0.01
72335588|NCT00322023|144194079|SUPERIORITY_OR_OTHER_LEGACY|||||||0.39|TWO_SIDED|95.0||||These are paired t test baseline vs final for 30mg/kg|t-test, 2 sided|||||||0.39
72335589|NCT00322023|144194079|SUPERIORITY||||||<|0.001||||||These are paired t test baseline vs final for 60mg/kg|t-test, 2 sided|||||||<0.001
72335590|NCT00322023|144194079|SUPERIORITY|||||||0.01||||||These are paired t test baseline vs final for 120mg/kg|t-test, 2 sided|||||||0.01
72426263|NCT00077636|144364356|NON_INFERIORITY_OR_EQUIVALENCE|In the analysis based on the standard population, end of treatment virological response was equivalent in the two treatment arms (94% in the 16-week arm and 92% in the 24-week arm).|Odds Ratio (OR)|1.32||||0.1941|TWO_SIDED|95.0|0.86|2.03|||Cochran-Mantel-Haenszel|stratified by country.||||2.03|0.86|0.1941
72426264|NCT00077636|144364357|NON_INFERIORITY_OR_EQUIVALENCE|These results indicated that sustained virological response achieved with 16 weeks of treatment was not equivalent to that achieved with 24 week of treatment.|Odds Ratio (OR)|0.65||||0.0003|TWO_SIDED|95.0|0.52|0.82|||Cochran-Mantel-Haenszel|stratified by country and HCV genotype.||||0.82|0.52|0.0003
72335591|NCT01155466|144194113|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.87|TWO_SIDED|95.0|-0.62|0.53|||Mixed Models Analysis||"The estimated parameter is the difference in the estimated mean change from baseline in mean off time for preladenant 10 mg - placebo."|||0.53|-0.62|0.8700
72335592|NCT01155466|144194115|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-2.6||||0.899|TWO_SIDED|95.0|-7.3|1.6|||Miettinen & Nurminen||The estimated parameter is the difference in the percentage of participants with diastolic blood pressure \>=105 mm Hg for preladenant 2 mg - placebo|||1.6|-7.3|0.899
72426265|NCT01993017|144364401|SUPERIORITY|||||||0.98||||||A 2-step gatekeeping test procedure was used. An omnibus F test using ANOVA comparing the 3 groups was first performed. Pairwise comparisons using a 2-sided t test at 5% nominal significance were planned only if the omnibus F test had a P value \<.05.|ANOVA|||We determined that a sample size per group of 500, assuming 5% loss to follow-up, would yield 80% power for a 2-sided t test at the 5% level. These calculations were based on an assumed SD for QALYs of 0.17, expected prevalence of screening-detected depression of 20%, and assumed net improvement in QALYs of 0.155 over 18 months for individuals with depression who received treatment for depression in the Screen, Notify, and Treat group.||||0.98
72335593|NCT01155466|144194115|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-1.9||||0.815|TWO_SIDED|95.0|-6.8|2.6|||Miettinen & Nurminen||The estimated parameter is the difference in the percentage of participants with diastolic blood pressure \>=105 mm Hg for preladenant 5 mg - placebo|||2.6|-6.8|0.815
72335594|NCT01155466|144194115|SUPERIORITY_OR_OTHER||Risk Difference (RD)|1.4||||0.295|TWO_SIDED|95.0|-3.9|6.9|||Miettinen & Nurminen||The estimated parameter is the difference in the percentage of participants with diastolic blood pressure \>=105 mm Hg for preladenant 10 mg - placebo|||6.9|-3.9|0.295
72335595|NCT01155466|144194118|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.6||||0.629|TWO_SIDED|95.0|-5.1|3.7|||Miettinen & Nurminen||The estimated parameter is the difference in the percentage of participants with suicidality for preladenant 2 mg - placebo|||3.7|-5.1|0.629
72335596|NCT01155466|144194118|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.6||||0.625|TWO_SIDED|95.0|-5.1|3.7|||Miettinen & Nurminen||The estimated parameter is the difference in the percentage of participants with suicidality for preladenant 5 mg - placebo|||3.7|-5.1|0.625
72335597|NCT01155466|144194118|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-2.6||||0.948|TWO_SIDED|95.0|-6.8|0.7|||Miettinen & Nurminen||The estimated parameter is the difference in the percentage of participants with suicidality for preladenant 10 mg - placebo|||0.7|-6.8|0.948
72335598|NCT01155466|144194119|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.1||||0.7044|TWO_SIDED|95.0|-0.61|0.9|||Constrained longitudinal data analysis||The estimated parameter is the difference in the change from baseline in mean ESS score for preladenant 2 mg - placebo|||0.90|-0.61|0.7044
72335599|NCT01155466|144194119|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.4||||0.3439|TWO_SIDED|95.0|-0.4|1.14|||Constrained longitudinal data analysis||The estimated parameter is the difference in the change from baseline in mean ESS score for preladenant 5 mg - placebo|||1.14|-0.4|0.3439
72335600|NCT01155466|144194119|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.3||||0.3941|TWO_SIDED|95.0|-0.43|1.08|||Constrained longitudinal data analysis||The estimated parameter is the difference in the change from baseline in mean ESS score for preladenant 10 mg - placebo|||1.08|-0.43|0.3941
72335601|NCT01155466|144194120|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.994||||0.983|TWO_SIDED|95.0|0.597|1.657|||Mixed Models Analysis|Odds ratio was calculated for all randomized and treated participants with at least 1 post treatment value.|"Confidence intervals and P-values were based on a generalized linear mixed model with baseline average off time as a covariate and treatment-by-time interaction as fixed effect and participant as random effect."|||1.657|0.597|0.983
72335602|NCT01155466|144194121|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2||||0.6405|TWO_SIDED|95.0|-0.49|0.8|||Mixed Models Analysis||"The estimated parameter is the difference in the estimated change from baseline in on time without troublesome dyskinesias for preladenant 10 mg - placebo."|||0.80|-0.49|0.6405
72335603|NCT03119181|144194123|SUPERIORITY|||||||0.0097|||||||one-sided permutation test|||one-sided permutation test at 2.5% significance||||0.0097
72335604|NCT00557310|144194137|SUPERIORITY_OR_OTHER|||||||0.363||95.0|||||Mixed Model Repeated Measurements|||||||0.363
72335605|NCT00557310|144194138|SUPERIORITY_OR_OTHER|||||||0.837||95.0|||||Mixed Model Repeated Measurements|||||||0.837
72335606|NCT00557310|144194139|SUPERIORITY_OR_OTHER|||||||0.816||95.0||||P-value is for the percent change from baseline at 18 months.|Mixed Model Repeated Measurements|||||||0.816
72335607|NCT00557310|144194139|SUPERIORITY_OR_OTHER|||||||0.934||95.0||||P-value is for the percent change from baseline at 24 months.|Mixed Model Repeated Measurements|||||||0.934
72335608|NCT00557310|144194140|SUPERIORITY_OR_OTHER|||||||0.324||95.0||||P-value is for the percent change from baseline at 18 months.|Mixed Model Repeated Measures|||||||0.324
72335609|NCT00557310|144194140|SUPERIORITY_OR_OTHER|||||||0.089||95.0||||P-value is for the percent change from baseline at 24 months.|Mixed Model Repeated Measures|||||||0.089
72426266|NCT02960763|144364410|SUPERIORITY|Repeated measure of 2\*2\*3 ANOVA with age (60 - 70, \> 70), time (baseline, end of Active phase of Step 1) by treatment group (3 levels). Tests were conducted with a Hochberg Step-down procedure. If the comparison with the lowest p-value \< 0.05/3 it is significant. If the second lowest p-value is also \< 0.05/2 then it also will be significant and if the third p-value is \< 0.05 then it also will be significant.||||||0.01||||||Equivalence of group|ANOVA|||||||0.010
72426267|NCT02960763|144364410|SUPERIORITY|Repeated measure of 2\*2\*3 ANOVA with age (60 - 70, \> 70), time (baseline, end of Active phase of Step 1) by treatment group (3 levels). Tests were conducted with a Hochberg Step-down procedure. If the comparison with the lowest p-value \< 0.05/3 it is significant. If the second lowest p-value is also \< 0.05/2 then it also will be significant and if the third p-value is \< 0.05 then it also will be significant.||||||0.004||||||augment with aripiprazole vs switch to bupropion|ANOVA|||||||0.004
72335610|NCT00557310|144194141|SUPERIORITY_OR_OTHER|||||||0.847||95.0|||||Mixed Model Repeated Measurements|P-value is for the percent change from baseline at 18 months.||||||0.847
72335611|NCT00557310|144194141|SUPERIORITY_OR_OTHER|||||||0.212||95.0||||P-value is for the percent change from baseline at 24 months.|Mixed Model Repeated Measurements|||||||0.212
72335612|NCT00557310|144194142|SUPERIORITY_OR_OTHER|||||||0.335||95.0|||||Mixed Model Repeated Measurements|P-value is for the percent change from baseline at 3 months.||||||0.335
72335613|NCT00557310|144194142|SUPERIORITY_OR_OTHER|||||||0.916||95.0||||P-value is for the percent change from baseline at 6 months.|Mixed Model Repeated Measurements|||||||0.916
72335614|NCT00557310|144194142|SUPERIORITY_OR_OTHER|||||||0.61||95.0||||P-value is for the percent change from baseline at 12 months.|Mixed Model Repeated Measurements|||||||0.610
72335615|NCT00557310|144194142|SUPERIORITY_OR_OTHER|||||||0.363||95.0|||||Mixed Model Repeated Measurements|P-value is for the percent change from baseline at 18 months.||||||0.363
72335616|NCT00557310|144194142|SUPERIORITY_OR_OTHER|||||||0.837||95.0||||P-value is for the percent change from baseline at 24 months.|Mixed Model Repeated Measurements|||||||0.837
72335617|NCT00557310|144194143|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA|||||||<0.001
72335618|NCT00557310|144194144|SUPERIORITY_OR_OTHER|||||||0.021||95.0|||||ANOVA|||||||0.021
72426268|NCT02960763|144364410|SUPERIORITY|Repeated measure of 2\*2\*3 ANOVA with age (60 - 70, \> 70), time (baseline, end of Active phase of Step 1) by treatment group (3 levels). Tests were conducted with a Hochberg Step-down procedure. If the comparison with the lowest p-value \< 0.05/3 it is significant. If the second lowest p-value is also \< 0.05/2 then it also will be significant and if the third p-value is \< 0.05 then it also will be significant.||||||0.017||||||augment with bupropion vs switch to bupropion|ANOVA|||||||0.017
72335619|NCT00557310|144194145|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA|||||||<0.001
72335620|NCT00557310|144194146|SUPERIORITY_OR_OTHER|||||||0.045||95.0|||||ANOVA|||||||0.045
72335621|NCT00557310|144194147|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for the percent change from baseline at 18 months.|ANOVA|||||||<0.001
72335622|NCT00557310|144194147|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for the percent change from baseline at 24 months.|ANOVA|||||||<0.001
72426269|NCT02960763|144364410|SUPERIORITY|||||||0.65|||||||ANOVA|||Repeated measure of 2\*2\*3 ANOVA with age (60 - 70, \> 70), time (baseline, end of Active phase of Step 1) by treatment group (3 levels). Tests were conducted with a Hochberg Step-down procedure. If the comparison with the lowest p-value \< 0.05/3 it is significant. If the second lowest p-value is also \< 0.05/2 then it also will be significant and if the third p-value is \< 0.05 then it also will be significant.||||0.650
72335623|NCT00557310|144194148|SUPERIORITY_OR_OTHER|||||||0.011||95.0||||P-value is for the percent change from baseline at 18 months.|ANOVA|||||||0.011
72335624|NCT00557310|144194148|SUPERIORITY_OR_OTHER|||||||0.049||95.0||||P-value is for the percent change from baseline at 24 months.|ANOVA|||||||0.049
72335625|NCT00557310|144194149|SUPERIORITY_OR_OTHER|||||||0.7||95.0||||P-value is for the percent change from baseline at 18 months.|ANOVA|||||||0.700
72335626|NCT00557310|144194149|SUPERIORITY_OR_OTHER|||||||0.092||95.0||||P-value is for the percent change from baseline at 24 months.|ANOVA|||||||0.092
72335627|NCT00557310|144194150|SUPERIORITY_OR_OTHER|||||||0.013||95.0||||P-value is for the percent change from baseline at 18 months.|ANOVA|||||||0.013
72335628|NCT00557310|144194150|SUPERIORITY_OR_OTHER|||||||0.005||95.0||||P-value is for the percent change from baseline at 24 months.|ANOVA|||||||0.005
72335629|NCT00557310|144194151|SUPERIORITY_OR_OTHER|||||||0.106||95.0||||P-value is for the percent change from baseline at 18 months.|ANOVA|||||||0.106
72335630|NCT00557310|144194151|SUPERIORITY_OR_OTHER|||||||0.436||95.0||||P-value is for the percent change from baseline at 24 months.|ANOVA|||||||0.436
72335631|NCT00557310|144194152|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for the percent change from baseline at 3 months.|Mixed Model Repeated Measurements|||||||<0.001
72335632|NCT00557310|144194152|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for the percent change from baseline at 6 months.|Mixed Model Repeated Measurements|||||||<0.001
72335633|NCT00557310|144194152|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for the percent change from baseline at 24 months.|Mixed Model Repeated Measurements|||||||<0.001
72335634|NCT00557310|144194153|SUPERIORITY_OR_OTHER|||||||0.012||95.0||||P-value is for the percent change from baseline at 3 months.|Mixed Model Repeated Measurements|||||||0.012
72335635|NCT00557310|144194153|SUPERIORITY_OR_OTHER|||||||0.012||95.0||||P-value is for the percent change from baseline at 6 months.|Mixed Model Repeated Measurements|||||||0.012
72335636|NCT00557310|144194153|SUPERIORITY_OR_OTHER|||||||0.016||95.0||||P-value is for the percent change from baseline at 24 months.|Mixed Model Repeated Measurements|||||||0.016
72335637|NCT00367744|144194162|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|Treatment groups were compared for change in limb fat using a two-sided signed rank test||The primary outcome measure was the change in limb fat at 48 weeks between the rosiglitazone and placebo group.||||0.02
72335638|NCT04699032|144194227|OTHER|Analysis of variance (ANOVA) was used to compare the natural log transformed Cmax for apraglutide between normal renal function group (Reference) and the severe impaired renal group (Test). Estimates of the mean differences and corresponding 90% confidence intervals (CIs) were obtained from the model. The mean differences and 90% CIs for the mean differences were exponentiated to provide estimates of the geometric least-square mean ratio (Test/Reference) and 90% CIs for the ratios.|Geometric least-square mean ratio|0.62|||||TWO_SIDED|90.0|0.423|0.909||||||||0.909|0.423|
72335639|NCT04699032|144194228|OTHER|ANOVA was used to compare the natural log transformed AUCinf for apraglutide between normal renal function group (Reference) and the severe impaired renal group (Test). Estimates of the mean differences and corresponding 90% CIs were obtained from the model. The mean differences and 90% CIs for the mean differences were exponentiated to provide estimates of the geometric least-square mean ratio (Test/Reference) and 90% CIs for the ratios.|Geometric least-square mean ratio|0.694|||||TWO_SIDED|90.0|0.458|1.05||||||||1.050|0.458|
72335640|NCT01271712|144194231|SUPERIORITY_OR_OTHER_LEGACY||||||<|1e-06|||||||Log Rank|stratified||The two treatment groups were compared using a stratified log rank test with a one-sided alpha of 0.01 stratified by (3rd vs 4th-line; and geographical region). The null hypothesis that both treatment arms have the same PFS distribution was tested against the alternative hypothesis that the distribution of PFS in the regorafenib arm is different from the control arm according to a proportional hazards relation between the treatment arms.||||<0.000001
72335641|NCT01271712|144194231|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.268|||||TWO_SIDED|95.0|0.185|0.388|||Regression, Cox|stratified|regorafenib over placebo|Hazard ratio and its 95% CI (Confidence Interval) was based on stratified Cox Regression Model||0.388|0.185|
72335642|NCT01271712|144194232|SUPERIORITY_OR_OTHER_LEGACY|||||||0.285777|||||||Log Rank|stratified||||||0.285777
72335643|NCT01271712|144194232|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.909|||||TWO_SIDED|95.0|0.653|1.265|||Regression, Cox|stratified|regorafenib over control. 58 (87.9%) patients in placebo group and 91 (68.4%) patients in regorafenib had started open-label treatment with regorafenib before time of final database cutoff 08 Jun 2015.|Hazard ratio and its 95% CI was based on stratified Cox Regression Model||1.265|0.653|
72335644|NCT01271712|144194233|SUPERIORITY_OR_OTHER_LEGACY||||||<|1e-06|||||||Log Rank|stratified||||||<0.000001
72335645|NCT01271712|144194233|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.248|||||TWO_SIDED|95.0|0.17|0.364|||Regression, Cox|stratified||||0.364|0.170|
72335646|NCT04270682|144194261|EQUIVALENCE|The null (H0) hypothesis and the alternative (Ha) hypothesis to be tested for the primary efficacy endpoint are that H0: Δ = 0 versus Ha: Δ ≠ 0 where Δ is the true paired treatment difference between CDCA and placebo for the change from baseline in loge-transformed urine 23S-pentol in the adult cohort.|Mean Difference (Final Values)|-3.06|STANDARD_ERROR_OF_MEAN|0.332|<|0.0001|TWO_SIDED|95.0|-3.794|-2.331|||paired t-test|||||-2.331|-3.794|<0.0001
72335647|NCT04270682|144194262|EQUIVALENCE|The null (H0) hypothesis and the alternative (Ha) hypothesis to be tested for the primary efficacy endpoint are that H0: Δ = 0 versus Ha: Δ ≠ 0 where Δ is the true paired treatment difference between CDCA and placebo for the change from baseline in loge-transformed plasma cholestanol in the adult cohort.|Mean Difference (Final Values)|-1.02|STANDARD_ERROR_OF_MEAN|0.241||0.0083|TWO_SIDED|95.0|-1.64|-0.399|||paired t-test|||||-0.399|-1.640|0.0083
72335648|NCT04270682|144194263|EQUIVALENCE|The null (H0) hypothesis and the alternative (Ha) hypothesis to be tested for the primary efficacy endpoint are that H0: Δ = 0 versus Ha: Δ ≠ 0 where Δ is the true paired treatment difference between CDCA and placebo for the change from baseline in loge-transformed Plasma 7αC4 in the adult cohort.|Mean Difference (Final Values)|-3.7|STANDARD_ERROR_OF_MEAN|0.224|<|0.0001|TWO_SIDED|95.0|-4.193|-3.207|||paired t-test|||||-3.207|-4.193|<0.0001
72335649|NCT04270682|144194264|EQUIVALENCE|Exact 2 sided p-value for observing contingency tables of rescue data with equal or more extreme values is calculated using Prescott's method. Rejection of the null hypothesis for no association suggests there is a difference between two treatments.|proportion|0.077||||0.0006|TWO_SIDED|95.0|0.0|0.36|||Prescott's|||||0.36|0.00|0.0006
72335650|NCT04270682|144194264|EQUIVALENCE|Exact 2 sided p-value for observing contingency tables of rescue data with equal or more extreme values is calculated using Prescott's method. Rejection of the null hypothesis for no association suggests there is a difference between two treatments.|proportion|0.62||||0.0006|TWO_SIDED|95.0|0.32|0.86|||Prescott's|||||0.86|0.32|0.0006
72335651|NCT05479097|144194265|SUPERIORITY||Median Difference (Net)|-7.5||||0.03232|TWO_SIDED|95.0|-12.0|-1.0||A priori threshold for statistical significance was P \<0.05.|Wilcoxon signed rank test|Systolic blood pressure was not normally distributed in the study sample, so nonparametric analysis was used.||The null hypothesis was that there was no change in systolic blood pressure.||-1.0|-12.0|0.03232
72335652|NCT05479097|144194266|SUPERIORITY||Mean Difference (Net)|-3.1||||0.045|TWO_SIDED|95.0|-6.1|-0.1||The a priori threshold for statistical significance was P \<0.05.|t-test, 2 sided|As diastolic blood pressure was normally distributed in our sample, we used a paired t-test to evaluate the mean difference in measurements.||The null hypothesis was that there was no change in diastolic blood pressure.||-0.1|-6.1|0.045
72335653|NCT05479097|144194267|SUPERIORITY|||||||0.7237||||||The a priori threshold for statistical significance was P \<0.05|McNemar|||The null hypothesis was no change in the proportion of patients with systolic blood pressure well-controlled (\<=140 mmHg) from baseline to 6 months.||||0.7237
72335654|NCT05479097|144194268|SUPERIORITY|||||||0.7237||||||The a priori threshold for statistical significance was P \<0.05|McNemar|||The null hypothesis was that there was no difference in the proportion of patients with systolic blood pressure less than or equal to their personalized goal from baseline to 6 months.||||0.7237
72335655|NCT03894969|144194305|NON_INFERIORITY|Non-inferiority is concluded if the lower limit of the two sided 95% CI for the GMC ratio for anti-PD is \> 0.667. The anti-PD GMC ratio is presented in this test with its 95% CI.|GMC ratio|0.942|||||TWO_SIDED|0.95|0.765|1.159|||ANCOVA|ANCOVA model with treatment group, age category, smoking status and center as fixed effects and pre-Dose 1 log-concentration as a covariate.||To demonstrate the non-inferiority (NI) of the humoral immune response 1 month after Dose 2 of GSK Biologicals' NTHi-Mcat investigational vaccine when administered 1 after Shingrix vaccine versus the humoral immune response 1 month after Dose 2 of GSKBiologicals' NTHi-Mcat investigational vaccine alone.||1.159|0.765|
72426270|NCT02960763|144364410|SUPERIORITY|||||||0.003||||||augmentation versus switch|ANOVA|||Repeated measure of 2\*2\*3 ANOVA with age (60 - 70, \> 70), time (baseline, end of Active phase of Step 1) by treatment group (3 levels). Tests were conducted with a Hochberg Step-down procedure. If the comparison with the lowest p-value \< 0.05/3 it is significant. If the second lowest p-value is also \< 0.05/2 then it also will be significant and if the third p-value is \< 0.05 then it also will be significant.||||0.003
72335656|NCT03894969|144194305|NON_INFERIORITY|Non-inferiority is concluded if the lower limit of the two sided 95% CI for the GMC ratio for anti-PE is \> 0.667. The anti-PE GMC ratio is presented in this test with its 95% CI.|GMC ratio|0.887|||||TWO_SIDED|0.95|0.719|1.093|||ANCOVA|ANCOVA model with treatment group, age category, smoking status and center as fixed effects and pre-Dose 1 log-concentration as a covariate.||To demonstrate the non-inferiority (NI) of the humoral immune response 1 month after Dose 2 of GSK Biologicals' NTHi-Mcat investigational vaccine when administered 1 after Shingrix vaccine versus the humoral immune response 1 month after Dose 2 of GSKBiologicals' NTHi-Mcat investigational vaccine alone.||1.093|0.719|
72426271|NCT02960763|144364410|SUPERIORITY|For those who proceed to Step 2, analogous repeated measures 2\*2\*2 ANOVA will be used with a significance level of .05 for the time\*treatment group comparison.||||||0.385|||||||ANOVA|||||||0.385
72426272|NCT02960763|144364411|SUPERIORITY|||||||0.038||||||Group effect|generalized linear model with logistic l|||||||0.038
72426273|NCT02960763|144364411|SUPERIORITY|||||||0.021||||||augmentation with aripiprazole vs switch to bupropion|generalized linear model with logistic l|||||||0.021
72335657|NCT03894969|144194305|NON_INFERIORITY|Non-inferiority is concluded if the lower limit of the two sided 95% CI for the GMC ratio for anti-PilA is \> 0.667. The anti-PilA GMC ratio is presented in this test with its 95% CI.|GMC ratio|1.142|||||TWO_SIDED|0.95|0.884|1.474|||ANCOVA|ANCOVA model with treatment group, age category, smoking status and center as fixed effects and pre-Dose 1 log-concentration as a covariate.||To demonstrate the non-inferiority (NI) of the humoral immune response 1 month after Dose 2 of GSK Biologicals' NTHi-Mcat investigational vaccine when administered 1 after Shingrix vaccine versus the humoral immune response 1 month after Dose 2 of GSKBiologicals' NTHi-Mcat investigational vaccine alone.||1.474|0.884|
72335658|NCT03894969|144194305|NON_INFERIORITY|Non-inferiority is concluded if the lower limit of the two sided 95% CI for the GMC ratio for anti-UspA2 is \> 0.667. The anti-UspA2 GMC ratio is presented in this test with its 95% CI.|GMC ratio|1.087|||||TWO_SIDED|0.95|0.948|1.245|||ANCOVA|ANCOVA model with treatment group, age category, smoking status and center as fixed effects and pre-Dose 1 log-concentration as a covariate.||To demonstrate the non-inferiority (NI) of the humoral immune response 1 month after Dose 2 of GSK Biologicals' NTHi-Mcat investigational vaccine when administered 1 after Shingrix vaccine versus the humoral immune response 1 month after Dose 2 of GSKBiologicals' NTHi-Mcat investigational vaccine alone.||1.245|0.948|
72335659|NCT00468676|144194322|SUPERIORITY_OR_OTHER||scaled marginal model parameter|-1.57|STANDARD_ERROR_OF_MEAN|0.28||0.001|TWO_SIDED|95.0|-2.12|-1.02||Significance of the four outcome composite|Scaled Marginal Model||Intervention group had significantly lower scaled marginal mean scores than usual care|||-1.02|-2.12|.001
72335660|NCT00468676|144194323|SUPERIORITY_OR_OTHER||Slope|0.01|||<|0.01||95.0|||||general estimating equations|||Disability outcomes were measured at six and 12 months after randomization using linear regression models adjusted for baseline values. The disability models combined information across time points and were estimated using general estimating equations to account for correlation. All analyses were based on intent to treat principles||||<0.01
72335661|NCT00468676|144194325|SUPERIORITY_OR_OTHER||Estimated Between Group Difference|-0.41|||<|0.001|TWO_SIDED|95.0|-0.56|-0.26|||Generalized-Estimating-Equation Model||Between Group Difference is the difference in the change from Baseline to 12 month data calculated from a generalized-estimating-equation model predicting a 6- and 12-month outcome.|||-0.26|-0.56|<0.001
72426274|NCT02960763|144364411|SUPERIORITY|||||||0.027||||||augmentation with bupropion vs switch to bupropion|generalized linear model with logistic l|||||||0.027
72426275|NCT02960763|144364411|SUPERIORITY|||||||0.934||||||Augmentation with aripiprazole v augmentation with bupropion|generalized linear model with logistic l|||||||0.934
72426276|NCT02960763|144364411|SUPERIORITY|||||||0.011||||||augmentation versus switch|generalized linear model with logistic l|||||||0.011
72426277|NCT02960763|144364411|SUPERIORITY|||||||0.5|||||||generalized linear model with logistic l|||||||0.500
72426278|NCT02960763|144364412|SUPERIORITY|||||||0.164||||||Cox models time to event comparing treatment arms.|Regression, Cox|||||||0.164
72426279|NCT02960763|144364412|SUPERIORITY|||||||0.103|||||||Regression, Cox|||||||0.103
72426280|NCT02960763|144364412|SUPERIORITY|||||||0.127|||||||Regression, Cox|||||||0.127
72426281|NCT02960763|144364412|SUPERIORITY|||||||0.524||||||Cox models to examine time to event comparing treatment arms.|Regression, Cox|||||||0.524
72335662|NCT00468676|144194326|SUPERIORITY_OR_OTHER||Estimated Between Group Difference|-3.4|||||TWO_SIDED|95.0|-6.9|0.1|||Generalized-Estimating-Equation Model||Between Group Difference is the difference in the change from Baseline to 12 month data calculated from a generalized-estimating-equation model predicting a 6- and 12-month outcome.|||0.1|-6.9|
72426282|NCT01421589|144364487|SUPERIORITY_OR_OTHER|||||||0.02|||||||Regression, Linear|||Univariate regression analyses was performed to assess the relationship between change in skeletal muscle IGF-1 mRNA expression after 12 weeks treatment with rhGH and change in ViPCr.||||0.02
72335663|NCT00468676|144194327|SUPERIORITY_OR_OTHER||Estimated Between Group Difference|-9.1|||||TWO_SIDED|95.0|-17.5|-0.8|||Regression, Linear||Between Group Difference is the difference in the change from Baseline to 12 month data calculated from a linear-regression model predicting a 12-month outcome.|||-0.8|-17.5|
72426283|NCT01421589|144364488|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
72426284|NCT01421589|144364489|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
72426285|NCT01421589|144364490|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
72426286|NCT01421589|144364491|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
72426287|NCT01421589|144364492|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
72426288|NCT01421589|144364493|SUPERIORITY_OR_OTHER||||||>|0.05|||||||t-test, 2 sided|||||||>0.05
72426289|NCT02694640|144364513|SUPERIORITY|The study was powered to detect significant between-group differences in mean min/week MVPA at follow-up.|effect size|0.11|||<|0.05|TWO_SIDED|||||No adjustment for multiple comparisons was made|Regression, Linear||Effect size refers to between-group difference at follow-up.|A series of longitudinal mixed effects models with subject-specific intercepts were used to examine between-group differences in mean min/week of self reported moderate-to-vigorous physical activity (MVPA).||||<.05
72426290|NCT02694640|144364514|SUPERIORITY||effect size|0.09|||<|0.05|TWO_SIDED||||||Regression, Linear|||||||<.05
72426291|NCT00759772|144364519|SUPERIORITY||||||<|0.01||||||Calculated p-value.|t-test, 2 sided|||||||< 0.01
72426292|NCT00737061|144364577|SUPERIORITY_OR_OTHER||Pregnancy Prevention Rate|98.9||||||95.0|97.9|100.0||||||1-sided confidence interval. No statistical hypothesis testing was performed. Confidence interval represents a 1-sided confidence interval for the pregnancy prevention rate in the EASE Trial. 95% confidence interval derived using Kaplan Meier methods (log-log with PETO adjustment).||100|97.9|
72426293|NCT00737061|144364577|SUPERIORITY_OR_OTHER||Pregnancy Prevention Rate|98.9||||||95.0|97.6|99.5||||||2-sided confidence interval. No statistical hypothesis testing was performed. Confidence interval represents a 2-sided confidence interval for the pregnancy prevention rate in the EASE Trial. 95% confidence interval derived using Kaplan Meier methods (log-log with PETO adjustment).||99.5|97.6|
72426294|NCT00737061|144364587|SUPERIORITY_OR_OTHER||Pregnancy Prevention Rate|98.4||||||95.0|97.2|100.0||||No statistical hypothesis testing was performed.||"1-sided Confidence Interval.~No hypothesis testing was performed. Confidence interval represents a 1-sided confidence interval for the pregnancy prevention rate in the EASE trial. 95% confidence interval derived using Kaplan Meier methods (log-log with PETO adjustment)."||100|97.2|
72335664|NCT00468676|144194328|SUPERIORITY_OR_OTHER||Estimated Between Group Difference|-0.56|||||TWO_SIDED|95.0|-0.85|-0.27|||Generalized-Estimating-Equation Model||Between Group Difference is the difference in the change from Baseline to 12 month data calculated from a generalized-estimating-equation model predicting a 6- and 12-month outcome.|||-0.27|-0.85|
72335665|NCT03569748|144194329|NON_INFERIORITY|Margin=0.04|Proportion Difference|0.1342||||0.0051|TWO_SIDED|95.0|0.0014|0.2671|||Chi-squared, Corrected|||H0: P1-P2 ≤ -Margin||0.2671|0.0014|0.0051
72335666|NCT03569748|144194330|SUPERIORITY|||||||0.0003|||||||Fisher Exact|||||||0.0003
72335667|NCT03569748|144194331|SUPERIORITY||Percentage Difference|14.2||||0.0003|TWO_SIDED||||||Chi-squared, Corrected|||||||0.0003
72335668|NCT00118846|144194354|SUPERIORITY||Slope|-0.91||||0.35|TWO_SIDED|95.0|-2.86|1.05|||Mixed Models Analysis||Slope = Mean difference in annualized rate of change|||1.05|-2.86|0.35
72335669|NCT00118846|144194355|OTHER||Mean Difference (Net)|0.11||||0.36|TWO_SIDED|95.0|-0.13|0.35|||ANCOVA|||||0.35|-0.13|0.36
72335670|NCT00443053|144194356|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.15|||<|0.001|TWO_SIDED|95.0|0.08|0.26|||Fisher Exact|||||0.26|0.08|<0.001
72335671|NCT00443053|144194357|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.19|||<|0.001|TWO_SIDED|95.0|0.12|0.32|||Fisher Exact|||||0.32|0.12|<0.001
72335672|NCT01574157|144194381|SUPERIORITY||Mean Difference (Final Values)|12.6|||||TWO_SIDED|95.0|-9.6|40.1||||||The primary analysis compared the mean change from baseline in the sodium bicarbonate group to the mean change from baseline in the placebo group.||40.1|-9.6|
72335673|NCT01574157|144194382|SUPERIORITY||Mean Difference (Final Values)|-10.1|||||TWO_SIDED|95.0|-38.2|30.8||||||The main analytic strategy for this secondary outcome was a comparison of the mean change from baseline in the sodium bicarbonate group to the mean change from baseline in the placebo group.||30.8|-38.2|
72335674|NCT01574157|144194383|SUPERIORITY||Mean Difference (Final Values)|-32.5|||||TWO_SIDED|95.0|-56.3|4.2||||||The main analytic strategy for this secondary outcome was a comparison of the mean change from baseline in the sodium bicarbonate group to the mean change from baseline in the placebo group.||4.2|-56.3|
72335675|NCT01574157|144194384|SUPERIORITY||Mean Difference (Final Values)|7.7|||||TWO_SIDED|95.0|-15.1|36.5||||||The main analytic strategy for this secondary outcome was a comparison of the mean change from baseline in the sodium bicarbonate group to the mean change from baseline in the placebo group.||36.5|-15.1|
72426295|NCT00737061|144364587|SUPERIORITY_OR_OTHER||Pregnancy Prevention Rate|98.4||||||95.0|96.9|99.1||||No statistical hypothesis testing was performed.||"2-sided Confidence Interval~No hypothesis testing was performed. Confidence interval represents a 2-sided confidence interval for the pregnancy prevention rate in the EASE trial. 95% confidence interval derived using Kaplan Meier methods (log-log with PETO adjustment)."||99.1|96.9|
72335676|NCT01574157|144194385|SUPERIORITY||Mean Difference (Final Values)|1.2|||||TWO_SIDED|95.0|-24.6|35.9||||||The main analytic strategy for this secondary outcome was a comparison of the mean change from baseline in the sodium bicarbonate group to the mean change from baseline in the placebo group.||35.9|-24.6|
72335677|NCT01574157|144194386|SUPERIORITY||Mean Difference (Final Values)|3.37|||||TWO_SIDED|95.0|-0.05|6.79||||||The main analytic strategy for this secondary outcome was a comparison of the mean change from baseline in the sodium bicarbonate group to the mean change from baseline in the placebo group.||6.79|-0.05|
72335678|NCT02956044|144194396|EQUIVALENCE|The acceptance range for bioequivalence is 80.0 - 125.00%|Ratio of Geometric LSM|108.73|||||TWO_SIDED|95.0|94.35|125.3|||||Confidence interval from ANOVA with treatment, period, and sequence as fixed effects, and subject as a random effect|Geometric Least Square (LS) Mean was used as PK parameters||125.30|94.35|
72335679|NCT02956044|144194396|EQUIVALENCE|The acceptance range for bioequivalence is 80.0 - 125.00%|Ratio of Geometric LSM|95.05|||||TWO_SIDED|90.0|84.73|106.63|||||Confidence interval from ANOVA with treatment, period, and sequence as fixed effects, and subject as a random effect|Geometric LS Mean was used as PK parameters||106.63|84.73|
72335680|NCT02956044|144194396|EQUIVALENCE|The acceptance range for bioequivalence is 80.0 - 125.00%|Ratio of Geometric LSM|89.44|||||TWO_SIDED|90.0|70.39|113.65|||||Confidence interval from ANOVA with treatment, period, and sequence as fixed effects, and subject as a random effect|Geometric LS Mean was used as PK parameters||113.65|70.39|
72335681|NCT02956044|144194396|EQUIVALENCE|The acceptance range for bioequivalence is 80.0 - 125.00%|Ratio of Geometric LSM|111.95|||||TWO_SIDED|90.0|97.02|129.19|||||Confidence interval from ANOVA with treatment, period, and sequence as fixed effects, and subject as a random effect|Geometric LS Mean was used as PK parameters||129.19|97.02|
72335682|NCT02956044|144194396|EQUIVALENCE|The acceptance range for bioequivalence is 80.0 - 125.00%|Ratio of Geometric LSM|126.68|||||TWO_SIDED|90.0|112.08|143.17|||||Confidence interval from ANOVA with treatment, period, and sequence as fixed effects, and subject as a random effect|Geometric LS Mean was used as PK parameters||143.17|112.08|
72335683|NCT02956044|144194396|EQUIVALENCE|The acceptance range for bioequivalence is 80.0 - 125.00%|Ratio of Geometric LSM|98.48|||||TWO_SIDED|90.0|84.9|114.23|||||Confidence interval from ANOVA with treatment, period, and sequence as fixed effects, and subject as a random effect|Geometric LS Mean was used as PK parameters||114.23|84.90|
72335684|NCT02956044|144194399|EQUIVALENCE|The acceptance range for bioequivalence is 80.0 - 125.00%|Ratio of Geometric LSM|87.36|||||TWO_SIDED|90.0|80.02|95.38|||||Confidence interval from ANOVA with treatment, period, and sequence as fixed effects, and subject as a random effect|Geometric LS Mean was used as PK parameters||95.38|80.02|
72335685|NCT02956044|144194399|EQUIVALENCE|The acceptance range for bioequivalence is 80.0 - 125.00%|Ratio of Geometric LSM|103.24|||||TWO_SIDED|90.0|94.59|112.68|||||Confidence interval from ANOVA with treatment, period, and sequence as fixed effects, and subject as a random effect|Geometric LS Mean was used as PK parameters||112.68|94.59|
72335686|NCT02956044|144194399|EQUIVALENCE|The acceptance range for bioequivalence is 80.0 - 125.00%|Ratio of Geometric LSM|94.46|||||TWO_SIDED|90.0|80.34|111.06|||||Confidence interval from ANOVA with treatment, period, and sequence as fixed effects, and subject as a random effect|Geometric LS Mean was used as PK parameters||111.06|80.34|
72335687|NCT02956044|144194399|EQUIVALENCE|The acceptance range for bioequivalence is 80.0 - 125.00%.|[Ratio of Geometric LSM]|127.19|||||TWO_SIDED|90.0|110.33|146.62|||||Confidence interval from ANOVA with treatment, period, and sequence as fixed effects, and subject as a random effect|Geometric LS Mean was used as PK parameters||146.62|110.33|
72426296|NCT01844115|144364593|SUPERIORITY||Least Squares Mean Difference|-2.2||||0.0048|TWO_SIDED|95.0|-3.72|-0.68|||MMRM|||||-0.68|-3.72|0.0048
72426297|NCT01844115|144364594|SUPERIORITY||Least Squares Mean Difference|-1.89||||0.0236|TWO_SIDED|95.0|-3.52|-0.26|||MMRM|||||-0.26|-3.52|0.0236
72426298|NCT01567865|144364667|EQUIVALENCE|The 3 lots of new GMP facility LJEVac would be considered equivalent (i.e., the SP does not differ between lots by ≥10%) if all 3 null hypotheses are rejected, and the alternate hypotheses are accepted.|Mean Difference (Net)|1.84|||||TWO_SIDED|95.0|-5.97|9.66||||||"Null hypotheses: each new lot does not differ in seroprotection (SP) rates among each other by more than 10%.~Slower than anticipated enrollment resulted in a smaller number of subjects with antibody response data for analysis. Consequently, additional power estimates were made in anticipation of the occurrence of smaller sample sizes. With a total study population of only 772 subjects, the power of the study to test lot-to-lot consistency declined from 90% to 85%."||9.66|-5.97|
72335688|NCT02956044|144194399|EQUIVALENCE|The acceptance range for bioequivalence is 80.0 - 125.00%|[Ratio of Geometric LSM]|113.09|||||TWO_SIDED|90.0|107.61|118.86|||||Confidence interval from ANOVA with treatment, period, and sequence as fixed effects, and subject as a random effect|Geometric LS Mean was used as PK parameters||118.86|107.61|
72335689|NCT02956044|144194399|EQUIVALENCE|The acceptance range for bioequivalence is 80.0 - 125.00%|[Ratio of Geometric LSM]|103.16|||||TWO_SIDED|90.0|99.3|107.17||||||Geometric LS Mean was used as PK parameters|Confidence interval from ANOVA with treatment, period, and sequence as fixed effects, and subject as a random effect|107.17|99.30|
72335690|NCT01263015|144194429|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority could be concluded if the lower bound of a two-sided 95% confidence interval for the difference (DTG + ABC/3TC minus EFV/TDF/FTC) in percentages between the two treatment arms was \> -10%.|Difference in percentage|7.3||||0.003|TWO_SIDED|95.0|2.3|12.2||P-value is for the test of superiority.|Wilcoxon (Mann-Whitney)||The estimated value reflects the percentage on DTG + ABC/3TC minus the percentage on EFV/TDF/FTC.|||12.2|2.3|0.003
72335691|NCT01263015|144194431|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority could be concluded if the lower bound of a two-sided 95% confidence interval for the difference (DTG + ABC/3TC minus EFV/TDF/FTC) in percentages between the two treatment arms was \> -10%.|Difference in percentage|7.1||||0.016|TWO_SIDED|95.0|1.2|13.1||P-value is for the test of superiority.|Wilcoxon (Mann-Whitney)||Week 96:The estimated value reflects the percentage on DTG + ABC/3TC minus the percentage on EFV/TDF/FTC.|||13.1|1.2|0.016
72335692|NCT01263015|144194431|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority could be concluded if the lower bound of a two-sided 95% confidence interval for the difference (DTG + ABC/3TC minus EFV/TDF/FTC) in percentages between the two treatment arms was \>-10%.|Difference in percentage|8.3||||0.01|TWO_SIDED|95.0|1.9|14.6||P-value is for the test of superiority.|Wilcoxon (Mann-Whitney)||Week 144:Estimated value reflects the percentage on DTG + ABC/3TC minus the percentage on EFV/TDF/FTC.|||14.6|1.9|0.010
72335693|NCT01263015|144194434|NON_INFERIORITY_OR_EQUIVALENCE|Adjusted mean is the estimated mean change from baseline (BL) in CD4 + Cell Count at Week 144 in each arm calculated from a repeated measures model including the following covariates: treatment, visit, BL plasma HIV-1 RNA, BL CD4 cell count, treatment\*visit interaction, BL HIV-1 RNA\*visit interaction and BL CD4 cell count\*visit interaction. No assumptions were made about the correlations between a par.'s readings of CD4 i.e. the correlation matrix for within-subject errors is unstructured.||||||0.003||95.0||||P-value is for the test of superiority.|Repeated Measure Mixed Model|||||||0.003
72335694|NCT05858450|144194440|OTHER||Weighted Hazard Ratio|1.108|||||TWO_SIDED|95.0|1.018|1.205||||||To account for imbalance in participant characteristics between the vaccine exposure groups, an inverse probability of treatment weights (IPTW) was applied. Analysis performed using IPTW method.||1.205|1.018|
72335695|NCT05858450|144194440|OTHER||Weighted Hazard Ratio|0.634|||||TWO_SIDED|95.0|0.606|0.664||||||To account for imbalance in participant characteristics between the vaccine exposure groups, an IPTW was applied. Analysis performed using IPTW method.||0.664|0.606|
72335696|NCT05858450|144194441|OTHER||Weighted Hazard Ratio|1.061|||||TWO_SIDED|95.0|1.016|1.107||||||To account for imbalance in participant characteristics between the vaccine exposure groups, an IPTW was applied. Analysis performed using IPTW method.||1.107|1.016|
72335697|NCT05858450|144194441|OTHER||Weighted Hazard Ratio|0.897|||||TWO_SIDED|95.0|0.875|0.919||||||To account for imbalance in participant characteristics between the vaccine exposure groups, an IPTW was applied. Analysis performed using IPTW method.||0.919|0.875|
72335698|NCT05858450|144194442|OTHER||Weighted Hazard Ratio|1.543|||||TWO_SIDED|95.0|1.133|2.1||||||To account for imbalance in participant characteristics between the vaccine exposure groups, an IPTW was applied. Analysis performed using IPTW method.||2.1|1.133|
72335699|NCT05858450|144194442|OTHER||Weighted Hazard Ratio|1.106|||||TWO_SIDED|95.0|1.014|1.206||||||To account for imbalance in participant characteristics between the vaccine exposure groups, an IPTW was applied. Analysis performed using IPTW method.||1.206|1.014|
72426299|NCT01567865|144364667|EQUIVALENCE|The 3 lots of new GMP facility LJEVac would be considered equivalent (i.e., the SP does not differ between lots by ≥10%) if all 3 null hypotheses are rejected, and the alternate hypotheses are accepted.|Mean Difference (Net)|-2.48|||<|0.05|TWO_SIDED|95.0|-9.92|4.98|||t-test, 2 sided|The 95% CI for the difference in rates is calculated based on the Newcombe-Wilson method without continuity correction.||"Null hypotheses: each new lot does not differ in seroprotection (SP) rates among each other by more than 10%.~Slower than anticipated enrollment resulted in a smaller number of subjects with antibody response data for analysis. Consequently, additional power estimates were made in anticipation of the occurrence of smaller sample sizes. With a total study population of only 772 subjects, the power of the study to test lot-to-lot consistency declined from 90% to 85%."||4.98|-9.92|<0.05
72426300|NCT01567865|144364667|EQUIVALENCE|The 3 lots of new GMP facility LJEVac would be considered equivalent (i.e., the SP does not differ between lots by ≥10%) if all 3 null hypotheses are rejected, and the alternate hypotheses are accepted.|Mean Difference (Net)|-4.33|||<|0.05|TWO_SIDED|95.0|-11.94|3.31|||t-test, 2 sided|||"Null hypotheses: each new lot does not differ in seroprotection (SP) rates among each other by more than 10%.~Slower than anticipated enrollment resulted in a smaller number of subjects with antibody response data for analysis. Consequently, additional power estimates were made in anticipation of the occurrence of smaller sample sizes. With a total study population of only 772 subjects, the power of the study to test lot-to-lot consistency declined from 90% to 85%."||3.31|-11.94|<0.05
72426301|NCT01567865|144364667|NON_INFERIORITY|The new GMP facility lots will be considered non-inferior (i.e., equivalent) to the existing facility lot if the null hypothesis is rejected and the alternate hypothesis is accepted.|Mean Difference (Net)|-4.03|||<|0.05|TWO_SIDED|95.0|-9.74|3.1|||t-test, 2 sided|The 95% CI for the difference in rates is calculated based on the Newcombe-Wilson method without continuity correction.||"Null hypothesis: reference lot vs. Lot 1, 2, and 3 combined do differ in seroprotection (SP) rates among each other by more than 10%.~Slower than anticipated enrollment resulted in a smaller number of subjects with antibody response data for analysis. Consequently, additional power estimates were made in anticipation of the occurrence of smaller sample sizes. The power of the study to test non-inferiority of the combined new lots compared to the reference lot dropped from 99% to 87%."||3.1|-9.74|<0.05
72335700|NCT05858450|144194443|OTHER||Weighted Hazard Ratio|1.048|||||TWO_SIDED|95.0|0.903|1.217||||||To account for imbalance in participant characteristics between the vaccine exposure groups, an IPTW was applied. Analysis performed using IPTW method.||1.217|0.903|
72335701|NCT05858450|144194443|OTHER||Weighted Hazard Ratio|0.908|||||TWO_SIDED|95.0|0.846|0.973||||||To account for imbalance in participant characteristics between the vaccine exposure groups, an IPTW was applied. Analysis performed using IPTW method.||0.973|0.846|
72335702|NCT05858450|144194444|OTHER||Weighted Hazard Ratio|1.137|||||TWO_SIDED|95.0|1.068|1.211||||||To account for imbalance in participant characteristics between the vaccine exposure groups, an IPTW was applied. Analysis performed using IPTW method.||1.211|1.068|
72335703|NCT05858450|144194444|OTHER||Weighted Hazard Ratio|1.057|||||TWO_SIDED|95.0|1.007|1.11||||||To account for imbalance in participant characteristics between the vaccine exposure groups, an IPTW was applied. Analysis performed using IPTW method.||1.11|1.007|
72335704|NCT05858450|144194445|OTHER||Weighted Hazard Ratio|0.761|||||TWO_SIDED|95.0|0.718|0.807||||||To account for imbalance in participant characteristics between the vaccine exposure groups, an IPTW was applied. Analysis performed using IPTW method.||0.807|0.718|
72335705|NCT05858450|144194445|OTHER||Weighted Hazard Ratio|0.858|||||TWO_SIDED|95.0|0.811|0.907||||||To account for imbalance in participant characteristics between the vaccine exposure groups, an IPTW was applied. Analysis performed using IPTW method.||0.907|0.811|
72335706|NCT05858450|144194446|OTHER||Weighted Hazard Ratio|1.55|||||TWO_SIDED|95.0|0.88|2.731||||||To account for imbalance in participant characteristics between the vaccine exposure groups, an IPTW was applied. Analysis performed using IPTW method.||2.731|0.88|
72335707|NCT05858450|144194446|OTHER||Weighted Hazard Ratio|1.035|||||TWO_SIDED|95.0|0.865|1.238||||||To account for imbalance in participant characteristics between the vaccine exposure groups, an IPTW was applied. Analysis performed using IPTW method.||1.238|0.865|
72335708|NCT05858450|144194447|OTHER||Weighted Hazard Ratio|0.921|||||TWO_SIDED|95.0|0.687|1.233||||||To account for imbalance in participant characteristics between the vaccine exposure groups, an IPTW was applied. Analysis performed using IPTW method.||1.233|0.687|
72335709|NCT05858450|144194447|OTHER||Weighted Hazard Ratio|0.826|||||TWO_SIDED|95.0|0.722|0.945||||||To account for imbalance in participant characteristics between the vaccine exposure groups, an IPTW was applied. Analysis performed using IPTW method.||0.945|0.722|
72335710|NCT05858450|144194448|OTHER||Weighted Hazard Ratio|1.569|||||TWO_SIDED|95.0|1.088|2.264||||||To account for imbalance in participant characteristics between the vaccine exposure groups, an IPTW was applied. Analysis performed using IPTW method.||2.264|1.088|
72426302|NCT00309608|144364682|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.67|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001||95.0|-0.95|-0.39||There was no adjustment for multiple testing, however a hierarchy approach to control for the Type-I error was used. If the 10mg was not successful, any analysis of the 5mg will be descriptive, and similarly for the next step for the 1mg.|Pairwise comparison based on ANCOVA|||"Linagliptin 10 mg vs. Placebo~Missing endpoints after 12 weeks of treatment were replaced using Last Observation Carried Forward (LOCF)"||-0.39|-0.95|<0.0001
72335711|NCT05858450|144194448|OTHER||Weighted Hazard Ratio|1.118|||||TWO_SIDED|95.0|1.015|1.233||||||To account for imbalance in participant characteristics between the vaccine exposure groups, an IPTW was applied. Analysis performed using IPTW method.||1.233|1.015|
72335712|NCT05858450|144194449|OTHER||Weighted Hazard Ratio|1.082|||||TWO_SIDED|95.0|0.911|1.286||||||To account for imbalance in participant characteristics between the vaccine exposure groups, an IPTW was applied. Analysis performed using IPTW method.||1.286|0.911|
72335713|NCT05858450|144194449|OTHER||Weighted Hazard Ratio|0.932|||||TWO_SIDED|95.0|0.859|1.01||||||To account for imbalance in participant characteristics between the vaccine exposure groups, an IPTW was applied. Analysis performed using IPTW method.||1.01|0.859|
72426303|NCT00309608|144364682|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.73|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001||95.0|-1.01|-0.44||There was no adjustment for multiple testing, however a hierarchy approach to control for the Type-I error was used. If the 10mg was not successful, any analysis of the 5mg will be descriptive, and similarly for the next step for the 1mg.|Pairwise comparison based on ANCOVA|||"Linagliptin 5 mg vs. Placebo~missing endpoints after 12 weeks of treatment were replaced using Last Observation Carried Forward (LOCF)"||-0.44|-1.01|<0.0001
72426304|NCT00309608|144364682|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.14||0.0055||95.0|-0.68|-0.12||There was no adjustment for multiple testing, however a hierarchy approach to control for the Type-I error was used. If the 10mg was not successful, any analysis of the 5mg will be descriptive, and similarly for the next step for the 1mg.|Pairwise comparison based on ANCOVA|||"Linagliptin 1 mg vs. Placebo~Missing endpoints after 12 weeks of treatment were replaced using Last Observation Carried Forward (LOCF)"||-0.12|-0.68|0.0055
72426305|NCT00309608|144364682|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.73|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001||95.0|-0.99|-0.46|||Pairwise comparison based on ANCOVA|||"Placebo vs. Linagliptin 10 mg~Analysis additionally adjusted for previous anti-diabetic medication.~Missing endpoints after 12 weeks of treatment were replaced using Last Observation Carried Forward (LOCF)."||-0.46|-0.99|<0.0001
72426306|NCT00309608|144364682|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.75|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001||95.0|-1.02|-0.48|||Pairwise comparison based on ANCOVA|||"Linagliptin 5 mg vs. Placebo~Analysis additionally adjusted for previous anti-diabetic medication.~Missing endpoints after 12 weeks of treatment were replaced using last observation carried forward (LOCF)."||-0.48|-1.02|<0.0001
72426307|NCT00309608|144364682|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.39|STANDARD_ERROR_OF_MEAN|0.14||0.0049||95.0|-0.66|-0.12|||Pairwise comparison based on ANCOVA|||"Linagliptin 1 mg vs. Placebo~Analysis additionally adjusted for previous anti-diabetic medication.~Missing endpoints after 12 weeks of treatment were replaced using last observation carried forward (LOCF)."||-0.12|-0.66|0.0049
72335714|NCT00132691|144194492|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.79|STANDARD_ERROR_OF_MEAN|2.03||0.16|TWO_SIDED|95.0|-1.16|6.68||unadjusted|Generalized estimating equations, linear||The treatment effect is a model-based comparison of within group treatment change from enrollment to 24 months (the difference of the differences - implant minus systemic).|"Null hypothesis: There will be no difference in change in visual acuity between treatment groups.~Assuming 67% bilateral disease, between eye correlation of 0.4, SD of 16 letters' change over 2 years and two-sided type 1 error rate of .05, a sample size of 250 provided 91% power (assuming 10% crossover) to detect a treatment difference of 7.5 standard ETDRS letters' change in visual acuity from baseline to 24 months."||6.68|-1.16|0.16
72335715|NCT00132691|144194493|SUPERIORITY_OR_OTHER||Ratio of odds ratios|0.61||||0.071|TWO_SIDED|95.0|0.34|1.03||unadjusted|GEE, logistic||For each treatment group the odds of macular edema at 2 yrs as compared to baseline was computed. The treatment effect is the ratio of these odds (implant divided by systemic).|||1.03|0.34|0.071
72426308|NCT00309608|144364683|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|18.575||||0.0054|TWO_SIDED|95.0|2.367|145.781|||Regression, Logistic|||Linagliptin 10 mg vs. Placebo||145.781|2.367|0.0054
72426309|NCT00309608|144364683|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|11.715||||0.0214|TWO_SIDED|95.0|1.439|95.351|||Regression, Logistic|||Linagliptin 5 mg vs. Placebo||95.351|1.439|0.0214
72335716|NCT00132691|144194494|SUPERIORITY_OR_OTHER||Ratio of odds ratios|0.29||||0.001|TWO_SIDED|95.0|0.13|0.6||unadjusted|GEE, logistic||For each treatment group the odds of uveitis activity at 2 years as compared to baseline was computed. The treatment effect represents the ratio of these odds (implant divided by systemic).|||.60|.13|0.001
72426310|NCT00309608|144364683|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|12.776||||0.0167|TWO_SIDED|95.0|1.586|102.895|||Regression, Logistic|||Linagliptin 1 mg vs. Placebo||102.895|1.586|0.0167
72426311|NCT00309608|144364683|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|31.36||||0.001|TWO_SIDED|95.0|4.063|242.028|||Regression, Logistic|||Glimepiride vs. Placebo||242.028|4.063|0.0010
72426312|NCT00309608|144364684|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-29.5|STANDARD_ERROR_OF_MEAN|6.07|<|0.0001||95.0|-41.4|-17.5|||Pairwise comparison based on ANCOVA|||Linagliptin 10mg vs. Placebo||-17.5|-41.4|<0.0001
72426313|NCT00309608|144364684|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-34.92|STANDARD_ERROR_OF_MEAN|6.16|<|0.0001||95.0|-47.0|-22.8|||Pairwise comparison based on ANCOVA|||Linagliptin 5mg vs. Placebo||-22.8|-47.0|<0.0001
72335717|NCT00132691|144194495|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|6.08|||<|0.0001|TWO_SIDED|95.0|3.32|11.15||unadjusted|Cox proportional hazards w/ RE||A Cox proportional hazards model with a random effect to account for between-eye correlation was used to estimate the relative hazard of experiencing an IOP of 30 mmHg or greater. The systemic arm was the reference group.|||11.15|3.32|<.0001
72335718|NCT00132691|144194496|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|3.59|||<|0.0001|TWO_SIDED|95.0|2.34|5.5||unadjusted|Cox proportional hazards w/ RE||A Cox proportional hazards model with a random effect to account for between-eye correlation was used to estimate the relative hazard of experiencing an IOP of 24 mmHg or greater. The systemic arm was the reference group|||5.50|2.34|<.0001
72335719|NCT00132691|144194497|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|4.28|||<|0.0001|TWO_SIDED|95.0|2.78|6.58||unadjusted|Cox proportional hazards with RE||A Cox proportional hazards model with a random effect to account for between-eye correlation was used to estimate the relative hazard of experiencing an IOP that was 10mmHg or greater than the baseline value. The systemic arm was the reference group.|||6.58|2.78|<.0001
72335720|NCT00132691|144194498|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|4.19||||0.0008|TWO_SIDED|95.0|1.82|9.63||unadjusted|Cox proportional hazards w/ RE||A Cox proportional hazards model with a random effect to account for between-eye correlation was used to estimate the relative hazard of developing glaucoma. The systemic arm was the reference group.|||9.63|1.82|0.0008
72335721|NCT00132691|144194499|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|4.16|||<|0.0001|TWO_SIDED|95.0|2.67|6.47||unadjusted|Cox proportional hazards w/ RE||A Cox proportional hazards model with a random effect to account for between-eye correlation was used to estimate the relative hazard of using an IOP-lowering therapy. The systemic arm was the reference group.|||6.47|2.67|<.0001
72335722|NCT00132691|144194500|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|8.4|||<|0.0001|TWO_SIDED|95.0|3.39|20.82||unadjusted|Cox proportional hazards w/ RE||A Cox proportional hazards model with a random effect to account for between-eye correlation was used to estimate the relative hazard of having surgery to lower IOP. The systemic arm was the reference group.|||20.82|3.39|<0.0001
72335723|NCT00132691|144194501|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|4.12|||<|0.0001|TWO_SIDED|95.0|2.21|7.67||unadjusted|Cox proportional hazards w/ RE||A Cox proportional hazards model with a random effect to account for between-eye correlation was used to estimate the relative hazard of developing a cataract. The systemic arm was the reference group.|||7.67|2.21|<0.0001
72335724|NCT00132691|144194502|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.64|STANDARD_ERROR_OF_MEAN|2.3||0.043|TWO_SIDED|95.0|0.14|9.15||unadjusted|GEE, linear||The treatment effect is a model-based comparison of within group treatment change from enrollment to 24 months (the difference of the differences - implant minus systemic).|||9.15|0.14|0.043
72335725|NCT00132691|144194503|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.62|STANDARD_ERROR_OF_MEAN|1.6||0.023|TWO_SIDED|95.0|0.49|6.76||unadjusted|GEE, linear||The treatment effect is a model-based comparison of within group treatment change from enrollment to 24 months (the difference of the differences - implant minus systemic)|||6.76|0.49|0.023
72335726|NCT00132691|144194504|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.95|STANDARD_ERROR_OF_MEAN|1.23||0.016|TWO_SIDED|95.0|0.54|5.36||unadjusted|Generalized Estimating Equations||The treatment effect is a model-based comparison of within group treatment change from enrollment to 24 months (the difference of the differences - implant minus systemic).|||5.36|0.54|0.016
72335727|NCT00132691|144194505|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.91||||0.84|TWO_SIDED|95.0|0.39|2.15||unadjusted|Regression, Cox||A Cox proportional hazards model was used to evaluate the relative hazard of hyperlipidemia for the implant and systemic treatments. The systemic treatment is the reference group.|||2.15|0.39|0.84
72335728|NCT00132691|144194506|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.4||||0.13|TWO_SIDED|95.0|0.13|1.29||unadjusted|Regression, Cox||A Cox proportional hazards model was used to evaluate the relative hazard of hypertension for the implant and systemic treatments. The systemic treatment is the reference group.|||1.29|0.13|0.13
72335729|NCT00132691|144194507|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.26||||0.24|TWO_SIDED|95.0|0.03|2.44||unadjusted|Regression, Cox||A Cox proportional hazards model was used to evaluate the relative hazard of diabetes mellitus for the implant and systemic treatments. The systemic treatment is the reference group.|||2.44|0.03|0.24
72426314|NCT00309608|144364684|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-18.95|STANDARD_ERROR_OF_MEAN|6.13||0.0022||95.0|-31.0|-6.87|||Pairwise comparison based on ANCOVA|||Linagliptin 1 mg vs. Placebo||-6.87|-31.0|0.0022
72335730|NCT04098367|144194513|SUPERIORITY|Superiority is concluded if the lower limit of the two-sided 97.5% confidence interval exceeds zero.|Difference in percentage|30.6|||||TWO_SIDED|97.5|13.34|46.79|||Miettinen-Nurminen||VIVITY minus SYMFONY|||46.79|13.34|
72335731|NCT04098367|144194513|SUPERIORITY|Superiority is concluded if the lower limit of the two-sided 97.5% confidence interval exceeds zero.|Difference in percentage|30.1|||||TWO_SIDED|97.5|12.54|46.68|||Miettinen-Nurminen||VIVITY minus AT LARA|||46.68|12.54|
72335732|NCT04098367|144194514|SUPERIORITY|Superiority is concluded if the lower limit of the two-sided 97.5% confidence interval exceeds zero.|Difference in percentage|-2.3|||||TWO_SIDED|97.5|-21.91|17.42|||Miettinen-Nurminen||VIVITY minus SYMFONY|||17.42|-21.91|
72335733|NCT04098367|144194514|SUPERIORITY|Superiority is concluded if the lower limit of the two-sided 97.5% confidence interval exceeds zero.|Difference in percentage|8.2|||||TWO_SIDED|97.5|-12.0|27.8|||Miettinen-Nurminen||VIVITY minus AT LARA|||27.80|-12.00|
72426315|NCT01288781|144364709|SUPERIORITY_OR_OTHER|||||||0.98||||||P \< 0.05 considered statistically significant.|ANOVA|Adjustments to the degrees of freedom were made when assumptions of sphericity were violated.||Omnibus analysis was performed. 2 (drug: Acetazolamide versus placebo) \* 2 (susceptibility: high altitude headache resistant versus high altitude headache susceptible) \* 6 (time: sea level, 3 \& 12; high altitude, 3, 12, 24 \& 36 hours) analysis of variance with repeated measures on the third factor. Data presented here are for the drug \* time interaction.||||0.98
72335734|NCT04098367|144194515|SUPERIORITY|Superiority is concluded if the lower limit of the two-sided 97.5% confidence interval exceeds zero.|Difference in percentage|23.5|||||TWO_SIDED|97.5|4.66|40.86|||Miettinen-Nurminen||VIVITY minus SYMFONY|||40.86|4.66|
72335735|NCT04098367|144194515|SUPERIORITY|Superiority is concluded if the lower limit of the two-sided 97.5% confidence interval exceeds zero.|Difference in percentage|40.7|||||TWO_SIDED|97.5|21.16|57.22|||Miettinen-Nurminen||VIVITY minus AT LARA|||57.22|21.16|
72335736|NCT01106859|144194542|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.8||||0.0174|TWO_SIDED|95.0|0.1|1.5||No p-value adjustment for multiple comparisons.|ANOVA|The degrees of freedom are 114 for the p-value testing the difference between treatment groups.||P-value is based on ANOVA model with fixed effects for sequence, period and treatment, a random effect for subject within sequence, and assuming compound symmetry covariance structure; the p-value is reported from LS Mean difference between Treatment Groups: LS mean of SDLP (Zolpidem 4 Hours) - LS mean of SDLP (Placebo).||1.5|0.1|0.0174
72335737|NCT01106859|144194542|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.5|||<|0.0001|TWO_SIDED|95.0|0.8|2.1||No p-value adjustment for multiple comparisons.|ANOVA|The degrees of freedom are 114 for the p-value testing the difference between treatment groups||P-value is based on ANOVA model with fixed effects for sequence, period and treatment, a random effect for subject within sequence, and assuming compound symmetry covariance structure; the p-value is reported from LS Mean difference between Treatment Groups: LS mean of SDLP (Zolpidem 3 Hours) - LS mean of SDLP (Placebo).||2.1|0.8|<0.0001
72426316|NCT01288781|144364710|SUPERIORITY_OR_OTHER|||||||0.63||95.0||||P \< 0.05 considered statistically significant.|ANOVA|Adjustments to the degrees of freedom were made when assumptions of sphericity were violated.||Omnibus analysis was performed. 2 (drug: Acetazolamide versus placebo) \* 2 (susceptibility: high altitude headache resistant versus high altitude headache susceptible) \* 6 (time: sea level, 3 \& 12; high altitude, 3, 12, 24 \& 36 hours) analysis of variance with repeated measures on the third factor. Data presented here are for the drug \* time interaction.||||0.63
72426317|NCT01288781|144364711|SUPERIORITY_OR_OTHER|||||||0.2||95.0||||P \< 0.05 considered statistically significant.|ANOVA|Adjustments to the degrees of freedom were made when assumptions of sphericity were violated.||Omnibus analysis was performed. 2 (drug: Acetazolamide versus placebo) \* 2 (susceptibility: high altitude headache resistant versus high altitude headache susceptible) \* 6 (time: sea level, 3 \& 12; high altitude, 3, 12, 24 \& 36 hours) analysis of variance with repeated measures on the third factor. Data presented here are for the drug \* time interaction.||||0.20
72335738|NCT01106859|144194542|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.5|||<|0.0001|TWO_SIDED|95.0|1.8|3.1||No p-value adjustment for multiple comparisons|ANOVA|The degrees of freedom are 114 for the p-value testing the difference between treatment groups||P-value is based on ANOVA model with fixed effects for sequence, period and treatment, a random effect for subject within sequence, and assuming compound symmetry covariance structure; the p-value is reported from LS Mean difference between Treatment Groups: LS mean of SDLP (Zopiclone) - LS mean of SDLP (Placebo).||3.1|1.8|<0.0001
72335739|NCT01106859|144194543|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.15||||0.0145|TWO_SIDED|95.0|0.03|0.27||No p-value adjustment for multiple comparisons|ANOVA|The degrees of freedom are 113 for the p-value testing the difference between treatment groups||P-value is based on ANOVA model with fixed effects for sequence, period and treatment, a random effect for subject within sequence, and assuming compound symmetry covariance structure; the p-value is reported from LS Mean difference between Treatment Groups: LS mean of SDS (Zolpidem 4 hours prior) - LS mean of SDS (Placebo).||0.27|0.03|0.0145
72335740|NCT01106859|144194543|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.08||||0.2179|TWO_SIDED|95.0|-0.05|0.2||No p-value adjustment for multiple comparisons|ANOVA|The degrees of freedom are 113 for the p-value testing the difference between treatment groups||P-value is based on ANOVA model with fixed effects for sequence, period and treatment, a random effect for subject within sequence, and assuming compound symmetry covariance structure; the p-value is reported from LS Mean difference between Treatment Groups: LS mean of SDS (Zolpidem 3 Hours) - LS mean of SDS (Placebo).||0.20|-0.05|0.2179
72335741|NCT01106859|144194543|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.16||||0.0096|TWO_SIDED|95.0|0.04|0.29||No p-value adjustment for multiple comparisons|ANOVA|The degrees of freedom are 113 for the p-value testing the difference between treatment groups||P-value is based on ANOVA model with fixed effects for sequence, period and treatment, a random effect for subject within sequence, and assuming compound symmetry covariance structure; the p-value is reported from LS Mean difference between Treatment Groups: LS mean of SDS (Zopiclone) - LS mean of SDS (Placebo).||0.29|0.04|0.0096
72335742|NCT01106859|144194546|SUPERIORITY_OR_OTHER|||||||0.2188||95.0||||No adjustments. The a priori threshold for statistical significance is 0.05.|McNemar|McNemar's exact test with one degree of freedom is used.||Symmetry analysis was performed for the probability of difference from placebo falling above and below the threshold of +/-2.5 cm in Standard Deviation of Lateral Position (SDLP) following administration of zolpidem tartrate sublingual tablet 4 hours prior to driving. Statistically significant asymmetries indicate a decrement in driving performance. Lack of statistical significance indicates symmetry which shows a lack of treatment effect on driving performance.||||0.2188
72335743|NCT01106859|144194546|SUPERIORITY_OR_OTHER|||||||0.0117||95.0||||No adjustments. The a priori threshold for statistical significance is 0.05.|McNemar|McNemar's exact test with one degree of freedom is used.||Symmetry analysis was performed for the probability of difference from placebo falling above and below the threshold of +/-2.5 cm in Standard Deviation of Lateral Position (SDLP) following administration of zolpidem tartrate sublingual tablet 3 hours prior to driving. Statistically significant asymmetries indicate a decrement in driving performance. Lack of statistical significance indicates symmetry which shows a lack of treatment effect on driving performance.||||0.0117
72335744|NCT01106859|144194546|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||No adjustments. The a priori threshold for statistical significance is 0.05.|McNemar|McNemar's exact test with one degree of freedom is used.||Symmetry analysis was performed for the probability of difference from placebo falling above and below the threshold of +/-2.5 cm in Standard Deviation of Lateral Position (SDLP) following administration of zopiclone 9 hours prior to driving. Statistically significant asymmetries indicate a decrement in driving performance. Lack of statistical significance indicates symmetry which shows a lack of treatment effect on driving performance.||||<0.0001
72335745|NCT01106859|144194548|SUPERIORITY_OR_OTHER|||||||0.125||95.0||||No adjustments. The a priori threshold for statistical significance is 0.05.|McNemar|McNemar's exact test with one degree of freedom is used.||Symmetry analysis was performed for the probability of difference from placebo falling above and below the threshold of +/-2.0 cm in Standard Deviation of Lateral Position (SDLP) following administration of zolpidem tartrate sublingual tablet 4 hours prior to driving. Statistically significant asymmetries indicate a decrement in driving performance. Lack of statistical significance indicates symmetry which shows a lack of treatment effect on driving performance.||||0.1250
72335746|NCT01106859|144194548|SUPERIORITY_OR_OTHER|||||||0.0074||95.0||||No adjustments. The a priori threshold for statistical significance is 0.05.|McNemar|McNemar's exact test with one degree of freedom is used.||Symmetry analysis was performed for the probability of difference from placebo falling above and below the threshold of +/-2.0 cm in Standard Deviation of Lateral Position (SDLP) following administration of zolpidem tartrate sublingual tablet 3 hours prior to driving. Statistically significant asymmetries indicate a decrement in driving performance. Lack of statistical significance indicates symmetry which shows a lack of treatment effect on driving performance.||||0.0074
72335747|NCT01106859|144194548|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||No adjustments. The a priori threshold for statistical significance is 0.05.|McNemar|McNemar's exact test with one degree of freedom is used.||Symmetry analysis was performed for the probability of difference from placebo falling above and below the threshold of +/-2.0 cm in Standard Deviation of Lateral Position (SDLP) following administration of Zopiclone 9 hours prior to driving. Statistically significant asymmetries indicate a decrement in driving performance. Lack of statistical significance indicates symmetry which shows a lack of treatment effect on driving performance.||||<0.0001
72335748|NCT01106859|144194550|SUPERIORITY_OR_OTHER|||||||0.5||95.0||||No adjustments. The a priori threshold for statistical significance is 0.05.|McNemar|McNemar's exact test with one degree of freedom is used.||Symmetry analysis was performed for the probability of difference from placebo falling above and below the threshold of +/-3.5 cm in Standard Deviation of Lateral Position (SDLP) following administration of zolpidem tartrate sublingual tablet 4 hours prior to driving. Statistically significant asymmetries indicate a decrement in driving performance. Lack of statistical significance indicates symmetry which shows a lack of treatment effect on driving performance.||||0.5000
72335749|NCT01106859|144194550|SUPERIORITY_OR_OTHER|||||||0.0156||95.0||||No adjustments. The a priori threshold for statistical significance is 0.05.|McNemar|McNemar's exact test with one degree of freedom is used.||Symmetry analysis was performed for the probability of difference from placebo falling above and below the threshold of +/-3.5 cm in Standard Deviation of Lateral Position (SDLP) following administration of zolpidem tartrate sublingual tablet 3 hours prior to driving. Statistically significant asymmetries indicate a decrement in driving performance. Lack of statistical significance indicates symmetry which shows a lack of treatment effect on driving performance.||||0.0156
72426318|NCT01288781|144364712|SUPERIORITY_OR_OTHER||||||<|0.01||95.0||||P \< 0.05 considered statistically significant.|ANOVA|Adjustments to the degrees of freedom were made when assumptions of sphericity were violated.||Omnibus analysis was performed. 2 (drug: Acetazolamide versus placebo) \* 2 (susceptibility: high altitude headache resistant versus high altitude headache susceptible) \* 6 (time: sea level, 3 \& 12; high altitude, 3, 12, 24 \& 36 hours) analysis of variance with repeated measures on the third factor. Data presented here are for the drug \* time interaction.||||<0.01
72426319|NCT01288781|144364712|SUPERIORITY_OR_OTHER||||||<|0.01||95.0||||Step down Holm Bonferroni correction was applied|t-test, 2 sided|||Post hoc follow up test. T test between acetazolamide and placebo on data at 24 hr time point.||||<0.01
72426320|NCT01288781|144364713|SUPERIORITY_OR_OTHER|||||||0.98||95.0||||P \< 0.05 considered statistically significant.|ANOVA|Adjustments to the degrees of freedom were made when assumptions of sphericity were violated.||Omnibus analysis was performed. 2 (drug: Acetazolamide versus placebo) \* 2 (susceptibility: high altitude headache resistant versus high altitude headache susceptible) \* 6 (time: sea level, 3 \& 12; high altitude, 3, 12, 24 \& 36 hours) analysis of variance with repeated measures on the third factor. Data presented here are for the drug \* time interaction.||||0.98
72426321|NCT01288781|144364714|SUPERIORITY_OR_OTHER|||||||0.98||95.0||||P \< 0.05 considered statistically significant.|ANOVA|Adjustments to the degrees of freedom were made when assumptions of sphericity were violated.||Omnibus analysis was performed. 2 (drug: Acetazolamide versus placebo) \* 2 (susceptibility: high altitude headache resistant versus high altitude headache susceptible) \* 6 (time: sea level, 3 \& 12; high altitude, 3, 12, 24 \& 36 hours) analysis of variance with repeated measures on the third factor. Data presented here are for the drug \* time interaction.||||0.98
72426322|NCT01288781|144364715|SUPERIORITY_OR_OTHER|||||||0.98||95.0||||P \< 0.05 considered statistically significant.|ANOVA|Adjustments to the degrees of freedom were made when assumptions of sphericity were violated.||Omnibus analysis was performed. 2 (drug: Acetazolamide versus placebo) \* 2 (susceptibility: high altitude headache resistant versus high altitude headache susceptible) \* 6 (time: sea level, 3 \& 12; high altitude, 3, 12, 24 \& 36 hours) analysis of variance with repeated measures on the third factor. Data presented here are for the drug \* time interaction.||||0.98
72426323|NCT03518658|144364716|SUPERIORITY||Mean Difference (Final Values)|34.7|||<|0.001|TWO_SIDED|95.0|32.4|37.0||The threshold for statistical significance was 0.025.|Generalized estimating equation model|||||37.0|32.4|<0.001
72426324|NCT03518658|144364716|SUPERIORITY||Mean Difference (Final Values)|38.3|||<|0.001|TWO_SIDED|95.0|34.8|41.9||The threshold for statistical significance was 0.025.|Generalized estimating equation model|||||41.9|34.8|<0.001
72426325|NCT00999661|144364719|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|39.8|STANDARD_DEVIATION|25.12|<|0.0001||95.0|36.6|43.1||One-sample t-test for change from baseline|t-test, 2 sided|||||43.1|36.6|<0.0001
72426326|NCT00999661|144364720|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|36.6|STANDARD_DEVIATION|19.79|<|0.0001||95.0|34.0|39.2|||t-test, 2 sided|||||39.2|34.0|<0.0001
72426327|NCT00999661|144364721|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.97|STANDARD_DEVIATION|5.233|<|0.0001||95.0|-8.65|-7.29|||t-test, 2 sided|||||-7.29|-8.65|<0.0001
72426328|NCT00917267|144364722|NON_INFERIORITY_OR_EQUIVALENCE|Superiority of exenatide once weekly to exenatide twice daily concluded if upper limit of the 2-sided 95% confidence interval for treatment difference is \<0; noninferiority concluded if upper limit is \<0.4%.|Least Squares Mean Difference|-0.31|STANDARD_ERROR_OF_MEAN|0.09|<|0.001|TWO_SIDED|95.0|-0.49|-0.14|||Mixed Models Analysis|||MMRM analysis of covariance (ANCOVA) model includes treatment, baseline HbA1c, country, background OAD, week of visit, and treatment-by-week interaction as fixed effects; and patient and error as random effects. Power: 306 patients per treatment group provides approximately 98% power to detect a true difference between treatments of 0.4% in change in HbA1c from baseline with a 2-sided t test at a significance level of 0.05, assuming a common standard deviation of 1.2%.||-0.14|-0.49|<.001
72426329|NCT00917267|144364723|SUPERIORITY_OR_OTHER|||||||0.003|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Percentage of patients achieving HbA1c target \<=7% at Week 26 were compared between treatments using a Cochran-Mantel-Haenszel (CMH) test, in which country and background OAD served as the stratification factors.||||0.003
72426330|NCT00917267|144364724|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Percentage of patients achieving HbA1c target \<=6.5% at Week 26 were compared between treatments using a CMH test, in which country and background OAD served as the stratification factors.||||<.001
72426331|NCT00917267|144364725|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-16.67|STANDARD_ERROR_OF_MEAN|2.97|<|0.001|TWO_SIDED|95.0|-22.5|-10.83|||Mixed Models Analysis|||MMRM ANCOVA model includes treatment, baseline FSG, country, background OAD, week of visit, and treatment-by-week interaction as fixed effects; and patient and error as random effects.||-10.83|-22.50|<.001
72426332|NCT00917267|144364726|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.82|STANDARD_ERROR_OF_MEAN|0.22|<|0.001|TWO_SIDED|95.0|0.39|1.25|||Mixed Models Analysis|||MMRM ANCOVA model includes treatment, baseline BW, country, background OAD, week of visit, and treatment-by-week interaction as fixed effects; and patient and error as random effects.||1.25|0.39|<.001
72426333|NCT00917267|144364727|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-1.31|STANDARD_ERROR_OF_MEAN|2.56||0.609|TWO_SIDED|95.0|-6.33|3.71|||Mixed Models Analysis|||MMRM ANCOVA model includes treatment, baseline TC, country, background OAD, week of visit, and treatment-by-week interaction as fixed effects; and patient and error as random effects.||3.71|-6.33|0.609
72426334|NCT00917267|144364728|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.37|STANDARD_ERROR_OF_MEAN|0.52||0.476|TWO_SIDED|95.0|-0.65|1.38|||Mixed Models Analysis|||MMRM ANCOVA model includes treatment, baseline HDL, country, background OAD, week of visit, and treatment-by-week interaction as fixed effects; and patient and error as random effects.||1.38|-0.65|0.476
72426335|NCT00917267|144364729|SUPERIORITY_OR_OTHER||Geometic Least Squares Mean Ratio|0.99|STANDARD_ERROR_OF_MEAN|0.03||0.807|TWO_SIDED|95.0|0.93|1.06|||Mixed Models Analysis|||TG data were logarithm-transformed and the change at Week 26 to baseline, expressed as the ratio, was analyzed using a MMRM ANCOVA model with treatment, baseline TG, country, background OAD, week of visit, and treatment-by-week interaction as fixed effects; and patient and error as random effects.||1.06|0.93|0.807
72426388|NCT01017120|144364764|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The p-value indicates treatment differences between tazarotene foam and vehicle foam for ILs|ANCOVA|||||||<0.001
72335750|NCT01106859|144194550|SUPERIORITY_OR_OTHER|||||||0.0001||95.0||||No adjustments. The a priori threshold for statistical significance is 0.05.|McNemar|McNemar's exact test with one degree of freedom is used.||Symmetry analysis was performed for the probability of difference from placebo falling above and below the threshold of +/-3.5 cm in Standard Deviation of Lateral Position (SDLP) following administration of zopiclone 9 hours prior to driving. Statistically significant asymmetries indicate a decrement in driving performance. Lack of statistical significance indicates symmetry which shows a lack of treatment effect on driving performance.||||0.0001
72426389|NCT01017120|144364764|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The p-value indicates treatment differences between tazarotene foam and vehicle foam for NILs|ANCOVA|||||||<0.001
72426390|NCT01017120|144364764|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The p-value indicates treatment differences between tazarotene foam and vehicle foam for TLs|ANCOVA|||||||<0.001
72426391|NCT01017120|144364765|SUPERIORITY_OR_OTHER||Percentage of participants|32.2|||<|0.001|TWO_SIDED|95.0|27.4|36.9|||Cochran-Mantel-Haenszel||The estimated value represents the percentage of participants receiving tazarotene foam with a minimum 2 G improvement in the ISGA score from Baseline at Week 12.|||36.9|27.4|<0.001
72426392|NCT01017120|144364765|SUPERIORITY_OR_OTHER||Percentage of participants|18.2|||||TWO_SIDED|95.0|14.2|22.1|||||The estimated value represents the percentage of participants receiving vehicle foam with a minimum 2 G improvement in the ISGA score from Baseline at Week 12.|||22.1|14.2|
72426393|NCT01017120|144364766|SUPERIORITY_OR_OTHER||Percentage of participants|27.6|||<|0.001|TWO_SIDED|95.0|23.1|32.2|||Cochran-Mantel-Haenszel||The estimated value represents the percentage of participants receiving tazarotene foam with an ISGA score of 0 or 1 at Week 12.|||32.2|23.1|<0.001
72426394|NCT01017120|144364766|SUPERIORITY_OR_OTHER||Percentage of participants|13.3|||||TWO_SIDED|95.0|9.8|16.7|||||The estimated value represents the percentage of participants receiving vehicle foam with an ISGA score of 0 or 1 at Week 12.|||16.7|9.8|
72426395|NCT00252590|144364791|SUPERIORITY_OR_OTHER|||||||0.32|TWO_SIDED||||||ANOVA|||||||0.32
72426396|NCT01702428|144364802|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|For each pair-wise comparison, the 2-sided 95% confidence interval (CI) on the lot difference in seroresponse rates should be within the \[-5%;5%\] margin for antibodies to measles virus.|Difference in seroresponse rate|-0.54|||||TWO_SIDED|95.0|-1.69|0.58|||||Asymptotic standardized 95% CI for the pair-wise differences in seroresponse.|Difference between groups (INV\_MMR\_L1 Group minus INV\_MMR\_L2 Group) in percentage of subjects with anti-measles antibody concentration ≥200 mIU/mL.||0.58|-1.69|
72426397|NCT01702428|144364802|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|For each pair-wise comparison, the 2-sided 95% confidence interval (CI) on the lot difference in seroresponse rates should be within the \[-5%;5%\] margin for antibodies to measles virus.|Difference in seroresponse rate|0.79|||||TWO_SIDED|95.0|-0.35|1.98|||||Asymptotic standardized 95% CI for the pair-wise differences in seroresponse.|Difference between groups (INV\_MMR\_L2 Group minus INV\_MMR\_L3 Group) in percentage of subjects with anti-measles antibody concentration ≥200 mIU/mL.||1.98|-0.35|
72335751|NCT03575065|144194578|SUPERIORITY|||||||0.021||||||p-value was based on an exact binomial test with historic control ORR=0.25|Exact Binomial Test|||||||0.0210
72426398|NCT01702428|144364802|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|For each pair-wise comparison, the 2-sided 95% confidence interval (CI) on the lot difference in seroresponse rates should be within the \[-5%;5%\] margin for antibodies to measles virus.|Difference in seroresponse rate|0.25|||||TWO_SIDED|95.0|-0.98|1.5|||||Asymptotic standardized 95% CI for the pair-wise differences in seroresponse.|Difference between groups (INV\_MMR\_L1 Group minus INV\_MMR\_L3 Group) in percentage of subjects with anti-measles antibody concentration ≥200 mIU/mL.||1.50|-0.98|
72426399|NCT01702428|144364803|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|For each pair-wise comparison, the 2-sided 95% CI on the lot ratio should be within the \[0.67;1.5\] margin for antibodies to measles.|Adjusted GMC ratio|0.99|||||TWO_SIDED|95.0|0.91|1.06|||ANOVA|95% CI for GMC of each INV\_MMR lots pair was computed using ANOVA (3 INV\_MMR lot groups \& country as fixed effects) on log-transformed concentrations.||Adjusted GMC ratio (INV\_MMR\_L1 Group divided by INV\_MMR\_L2 Group) for antibodies to measles virus at Day 42.||1.06|0.91|
72426400|NCT01702428|144364803|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|For each pair-wise comparison, the 2-sided 95% CI on the lot ratio should be within the \[0.67;1.5\] margin for antibodies to measles.|Adjusted GMC ratio|0.97|||||TWO_SIDED|95.0|0.9|1.05|||ANOVA|95% CI for GMC of each INV\_MMR lots pair was computed using ANOVA (3 INV\_MMR lot groups \& country as fixed effects) on log-transformed concentrations.||Adjusted GMC ratio (INV\_MMR\_L1 Group divided by INV\_MMR\_L3 Group) for antibodies to measles virus at Day 42.||1.05|0.90|
72426401|NCT01702428|144364803|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|For each pair-wise comparison, the 2-sided 95% CI on the lot ratio should be within the \[0.67;1.5\] margin for antibodies to measles.|Adjusted GMC ratio|1.01|||||TWO_SIDED|95.0|0.94|1.09|||ANOVA|95% CI for GMC of each INV\_MMR lots pair was computed using ANOVA (3 INV\_MMR lot groups \& country as fixed effects) on log-transformed concentrations.||Adjusted GMC ratio (INV\_MMR\_L2 Group divided by INV\_MMR\_L1 Group) for antibodies to measles virus at Day 42.||1.09|0.94|
72426402|NCT01702428|144364803|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|For each pair-wise comparison, the 2-sided 95% CI on the lot ratio should be within the \[0.67;1.5\] margin for antibodies to measles.|Adjusted GMC ratio|0.99|||||TWO_SIDED|95.0|0.91|1.06|||ANOVA|95% CI for GMC of each INV\_MMR lots pair was computed using ANOVA (3 INV\_MMR lot groups \& country as fixed effects) on log-transformed concentrations.||Adjusted GMC ratio (INV\_MMR\_L2 Group divided by INV\_MMR\_L3 Group) for antibodies to measles virus at Day 42.||1.06|0.91|
72335752|NCT01685801|144194588|SUPERIORITY_OR_OTHER||Posterior Mean|2.251|STANDARD_DEVIATION|0.961|||TWO_SIDED|95.0|0.383|4.144|||||The posterior distribution of overall treatment difference was obtained using the Bayesian hierarchical model and 95% credible interval of the treatment effect (posterior mean) was calculated.|"This statistical analysis is for Overall category."||4.144|0.383|
72335753|NCT04686084|144194597|OTHER|Bland-Altman analysis|Median Difference (Final Values)|0.04|||||TWO_SIDED|||||||||||||
72335754|NCT01528891|144194655|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED|||||"P\<0.01 for the following time points, 1 minute, 2 minutes, 3 minutes, 4 minutes, 5 minutes, and PACU.~P-values are adjusted for multiple comparisons."|t-test, 2 sided|||Heart rate values at each time point were compared between groups.||||<0.01
72335755|NCT01528891|144194655|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED|||||"P\<0.01 for the following time points, as compared to the baseline value: 1 minute, 2 minutes, 3 minutes, 4 minutes, 5 minutes, and PACU.~P-values are adjusted for multiple comparisons."|ANOVA|||Heart rate values were compared over time against the baseline value.||||<0.01
72335756|NCT01528891|144194655|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED|||||"P\<0.01 for the following time points, as compared to the baseline value: 4 minutes, 5 minutes, and PACU.~P-values are adjusted for multiple comparisons."|ANOVA|||Heart rate values were compared over time against the baseline value.||||<0.01
72335757|NCT01528891|144194656|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P\<0.0001 was calculated for both groups.|Fisher Exact|||The incidence of agitated patients in each group was compared.||||<0.0001
72335758|NCT01528891|144194657|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED|||||"P\<0.01 for the following time points: 1 minute, 4 minutes, 5 minutes, and PACU.~P-values are adjusted for multiple comparisons."|t-test, 2 sided|||Systolic blood pressure values were compared between groups at each time point.||||<0.01
72335759|NCT01528891|144194657|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED|||||"P\<0.01 for the following time points, as compared to the baseline value: 1 minute, 3 minutes, 4 minutes, and 5 minutes.~P-values are adjusted for multiple comparisons."|ANOVA|||SBP values were compared against the baseline value within each group over time.||||<0.01
72335760|NCT01528891|144194657|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED|||||"P\<0.01 for the following time points, as compared to the baseline value: 5 minutes and PACU.~P-values were adjusted for multiple comparisons."|ANOVA|||SBP values were compared against the baseline within each group over time.||||<0.01
72335761|NCT01528891|144194658|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED|||||"P\<0.01 for the following time points: 1 minute and PACU.~P-values were adjusted for multiple comparisons."|t-test, 2 sided|||DBP values were compared between groups at each time point.||||<0.01
72335762|NCT01528891|144194658|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED|||||"P\<0.01 for the following time points, as compared to baseline: 1 minute, 3 minutes, 4 minutes, 5 minutes, PACU.~P-values were adjusted for multiple comparisons."|ANOVA|||DBP values were compared within each group against the baseline value.||||<0.01
72335763|NCT01528891|144194658|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED|||||"P\<0.01 for the following time points, as compared to baseline: 4 minutes, 5 minutes, PACU.~P-values were adjusted for multiple comparisons."|ANOVA|||DBP values were compared against the baseline value within each group over time.||||<0.01
72335764|NCT04452435|144194659|EQUIVALENCE|The null hypothesis was that the treatments were equivalent and was to be rejected in favour of the alternative hypothesis that a treatment difference existed, if the probability of the null hypothesis being true was less than 10%.|||||=|0.4891|||||||ANCOVA|||||||=0.4891
72335765|NCT04452435|144194659|EQUIVALENCE|The null hypothesis was that the treatments were equivalent and was to be rejected in favour of the alternative hypothesis that a treatment difference existed, if the probability of the null hypothesis being true was less than 10%.|||||=|0.0881|||||||ANCOVA|||A subgroup analyses was performed in subjects with supplemental oxygen use at baseline. A total of 26 subjects in the C21 group and 27 in the placebo group were included in the analysis of change in CRP from baseline to the mean of the last 2 non-missing scheduled assessments during the treatment period by baseline supplemental oxygen use.||||=0.0881
72335766|NCT04452435|144194660|EQUIVALENCE|The null hypothesis was that the treatments were equivalent and was to be rejected in favour of the alternative hypothesis that a treatment difference existed, if the probability of the null hypothesis being true was less than 10%.|||||=|0.0492|||||||ANCOVA|||||||=0.0492
72335767|NCT04452435|144194661|EQUIVALENCE|The null hypothesis was that the treatments were equivalent and was to be rejected in favour of the alternative hypothesis that a treatment difference existed, if the probability of the null hypothesis being true was less than 10%.|||||=|0.9923|||||||ANCOVA|||||||=0.9923
72335768|NCT04452435|144194662|EQUIVALENCE|The null hypothesis was that the treatments were equivalent and was to be rejected in favour of the alternative hypothesis that a treatment difference existed, if the probability of the null hypothesis being true was less than 10%.|||||=|0.5355|||||||ANCOVA|||||||=0.5355
72335769|NCT04452435|144194663|EQUIVALENCE|The null hypothesis was that the treatments were equivalent and was to be rejected in favour of the alternative hypothesis that a treatment difference existed, if the probability of the null hypothesis being true was less than 10%.|||||=|0.4738|||||||ANCOVA|||||||=0.4738
72335770|NCT04452435|144194664|EQUIVALENCE|The null hypothesis was that the treatments were equivalent and was to be rejected in favour of the alternative hypothesis that a treatment difference existed, if the probability of the null hypothesis being true was less than 10%.|||||=|0.9418|||||||ANCOVA|||||||=0.9418
72335771|NCT04452435|144194665|EQUIVALENCE|The null hypothesis was that the treatments were equivalent and was to be rejected in favour of the alternative hypothesis that a treatment difference existed, if the probability of the null hypothesis being true was less than 10%.|||||=|0.9733|||||||ANCOVA|||||||=0.9733
72335772|NCT04452435|144194666|EQUIVALENCE|The null hypothesis was that the treatments were equivalent and was to be rejected in favour of the alternative hypothesis that a treatment difference existed, if the probability of the null hypothesis being true was less than 10%.|||||=|0.0568|||||||Regression, Logistic|||||||=0.0568
72335773|NCT04452435|144194667|EQUIVALENCE|The null hypothesis was that the treatments were equivalent and was to be rejected in favour of the alternative hypothesis that a treatment difference existed, if the probability of the null hypothesis being true was less than 10%.|||||=|0.6088|||||||Regression, Logistic|||||||=0.6088
72335774|NCT04452435|144194668|EQUIVALENCE|The null hypothesis was that the treatments were equivalent and was to be rejected in favour of the alternative hypothesis that a treatment difference existed, if the probability of the null hypothesis being true was less than 10%.|||||=|0.5757|||||||Log Rank|||||||=0.5757
72335775|NCT04452435|144194669|EQUIVALENCE|The null hypothesis was that the treatments were equivalent and was to be rejected in favour of the alternative hypothesis that a treatment difference existed, if the probability of the null hypothesis being true was less than 10%.|||||=|0.8588|||||||Wilcoxon (Mann-Whitney)|||||||=0.8588
72335776|NCT04452435|144194671|EQUIVALENCE|The null hypothesis was that the treatments were equivalent and was to be rejected in favour of the alternative hypothesis that a treatment difference existed, if the probability of the null hypothesis being true was less than 10%.|||||=|0.003|||||||Chi-squared|||||||=0.003
72335777|NCT00957944|144194776|NON_INFERIORITY_OR_EQUIVALENCE|If the 90% Confidence Interval for the ratio of geometric LS- Means is included within 0.8- 1.25, the patches are considered bioequivalent.|ratio of geometric LS- Means|1.0302||||||90.0|0.9693|1.0951|||ANOVA|ANOVA for log- transformed values has been used as the basis for calculation of point estimates (LS- Means) and Confidence Intervals (CIs).|Bioequivalence is concluded if the 90% CIs for the ratio Treatment A/ Treatment B are fully included in the acceptance range from 0.8- 1.25 for AUC(0-tz), AUC(0-inf) and Cmax.|Bioequivalence testing by using the 90% Confidence Interval (CI).||1.0951|0.9693|
72335778|NCT00957944|144194777|NON_INFERIORITY_OR_EQUIVALENCE|If the 90% Confidence Interval for the ratio of geometric LS- Means is included within 0.8- 1.25, the patches are considered bioequivalent.|ratio of geometric LS- Means|1.0571||||||90.0|0.9903|1.1284|||ANOVA|ANOVA for log- transformed values has been used as the basis for calculation of point estimates (LS- Means) and Confidence Intervals (CIs).|Bioequivalence is concluded if the 90% CIs for the ratio Treatment A/ Treatment B are fully included in the acceptance range from 0.8- 1.25 for AUC(0-tz), AUC(0-inf) and Cmax.|Bioequivalence testing by using the 90% Confidence Interval (CI).||1.1284|0.9903|
72335779|NCT00957944|144194778|NON_INFERIORITY_OR_EQUIVALENCE|If the 90% Confidence Interval for the ratio of geometric LS- Means is included within 0.8- 1.25, the patches are considered bioequivalent.|ratio of geometric LS- Means|1.0289||||||90.0|0.9714|1.0899|||ANOVA|ANOVA for log- transformed values has been used as the basis for calculation of point estimates (LS- Means) and Confidence Intervals (CIs).|Bioequivalence is concluded if the 90% CIs for the ratio Treatment A/ Treatment B are fully included in the acceptance range from 0.8- 1.25 for AUC(0-tz), AUC(0-inf) and Cmax.|Bioequivalence testing by using the 90% Confidence Interval (CI).||1.0899|0.9714|
72335780|NCT00522418|144194791|SUPERIORITY_OR_OTHER|||||||0.01|TWO_SIDED||||||F Test|||||||.01
72335781|NCT00522418|144194794|SUPERIORITY_OR_OTHER|||||||0.17|TWO_SIDED||||||F-Test|||||||0.17
72335782|NCT00522418|144194797|SUPERIORITY_OR_OTHER|||||||0.17|TWO_SIDED||||||F-Test|||||||0.17
72335783|NCT00522418|144194798|SUPERIORITY_OR_OTHER|||||||0.28|TWO_SIDED||||||F-Test|||||||0.28
72335784|NCT00522418|144194799|SUPERIORITY_OR_OTHER|||||||0.03|TWO_SIDED||||||F-Test|||||||0.03
72335785|NCT00522418|144194800|SUPERIORITY_OR_OTHER|||||||0.26|TWO_SIDED||||||F-Test|||||||0.26
72335786|NCT02139878|144194815|SUPERIORITY_OR_OTHER||||||=|0.088|||||||ANCOVA|||||||=0.088
72335787|NCT02139878|144194816|SUPERIORITY_OR_OTHER||||||=|0.98|||||||ANCOVA|||||||=0.980
72335788|NCT00737568|144194822|SUPERIORITY_OR_OTHER|||||||0.43|TWO_SIDED|||||The p-value for the two-sided Cochran-Mantel-Haenszel test was controlled for strata (HBeAg status and ALT level).|Cochran-Mantel-Haenszel|||The null hypothesis is that there is no difference between the FTC/TDF and TDF treatment groups. The alternative hypothesis is that there is a difference between the FTC/TDF and TDF treatment groups. These hypotheses were evaluated using a Cochran-Mantel-Haenszel (CMH) test, controlling for randomization strata, with the missing = failure method in which participants with missing data were considered to have failed to achieve the endpoint.||||0.43
72335789|NCT00855933|144194835|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.066||0.126|TWO_SIDED|95.0|-0.03|0.24||a priori threshold for statistical significance = 0.05|ANCOVA||2-sided with the significance level set at 5%|||0.24|-0.03|0.126
72335790|NCT01960998|144194837|SUPERIORITY|||||||0.22||||||P value not adjusted for multiple comparisons|Log Rank||||Data were not collected beyond the 12-month follow up, at which point fewer than 50% of participants in both groups had achieved continence. Thus, their time to continence could not be determined and the medians could not be calculated.|||0.22
72335791|NCT01960998|144194838|SUPERIORITY|||||||0.7||||||P values were not corrected for multiple testing|ANCOVA|Baseline score was included as a covariate in analysis.|||Mean values for the telehealth and no telehealth groups on the ICIQ-SF are presented above. Multiple imputation was performed to account for missing data, using the Multiple Imputation via Chained Equations (MICE) package in R. Across 10 imputations, the mean ICIQ-SF score in the no telehealth group at 6 months was 7.0 (standard deviation 4.4) and in the telehealth group was 7.1 (SD 4.3). Analysis of covariance (ANCOVA) was performed with each of the 10 imputations, adjusting for baseline ICIQ-SF score, and p values were combined using the Rubin-Licht method.|||0.70
72426403|NCT01702428|144364803|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|For each pair-wise comparison, the 2-sided 95% CI on the lot ratio should be within the \[0.67;1.5\] margin for antibodies to measles.|Adjusted GMC ratio|1.03|||||TWO_SIDED|95.0|0.95|1.11|||ANOVA|95% CI for GMC of each INV\_MMR lots pair was computed using ANOVA (3 INV\_MMR lot groups \& country as fixed effects) on log-transformed concentrations.||Adjusted GMC ratio (INV\_MMR\_L3 Group divided by INV\_MMR\_L1 Group) for antibodies to measles virus at Day 42.||1.11|0.95|
72335792|NCT01960998|144194839|SUPERIORITY|||||||0.7||||||P values were not adjusted for multiple comparisons.|ANCOVA||||Mean values for the telehealth and no telehealth groups on the EPIC-UI are presented above. Multiple imputation was performed to account for missing data, using the Multiple Imputation via Chained Equations (MICE) package in R. Across 10 imputations, the mean EPIC-UI score in the no telehealth group at 6 months was 63.5 (standard deviation 24.1) and in the telehealth group was 63.9 (SD 22.1). Analysis of covariance (ANCOVA) was performed with each of the 10 imputations, adjusting for baseline EPIC-UI score, and p values were combined using the Rubin-Licht method.|||0.70
72335793|NCT01960998|144194840|SUPERIORITY|||||||0.46||||||P values not adjusted for multiple comparisons.|t-test, 2 sided||||Mean values for the telehealth and no telehealth groups on the IIQ are presented above. Multiple imputation was performed to account for missing data, using the Multiple Imputation via Chained Equations (MICE) package in R. Across 10 imputations, the mean IIQ score in the no telehealth group at 6 months was 22.3 (standard deviation 24.1) and in the telehealth group was 19.4 (SD 22.4). Two-sample t-tests were performed with each of the 10 imputations, and p values were combined using the Rubin-Licht method.|||0.46
72335794|NCT01960998|144194841|SUPERIORITY|||||||0.63||||||P values were not corrected for multiple comparisons|Chi-squared, Corrected||||Frequencies for the telehealth and no telehealth groups on the Quality of Life question are presented above. Multiple imputation was performed to account for missing data, using the Multiple Imputation via Chained Equations (MICE) package in R. Across 10 imputations, the mean frequencies for the no telehealth group at 6 months were 31.4% (Delighted/Pleased), 22.8% (Mostly Satisfied), 19.4% (Mixed), 12.0% (Mostly Dissatisfied), and 14.4% (Unhappy/Terrible) and in the telehealth group were 20.8%, 26.3%, 26.3%, 12.6%, and 14.0%, respectively. Chi-squared analysis with continuity correction was used to determine if there were differences in the observed frequencies between groups (telehealth versus no telehealth) across the 5 levels of the IPSS Quality of Life question relative to the expected frequencies with each of the imputations, and p values were combined using the Enders (2001) method.|||0.63
72335795|NCT01960998|144194842|SUPERIORITY|||||||0.04||||||P values were not corrected for multiple comparisons|Chi-squared, Corrected||||Frequencies for the telehealth and no telehealth groups on the Patient Satisfaction question are presented above. Multiple imputation was performed to account for missing data, using the Multiple Imputation via Chained Equations (MICE) package in R. Across 10 imputations, the mean frequencies for the no telehealth group at 6 months were 51.0% (Completely Satisfied), 40.2% (Somewhat Satisfied), and 8.7% (Not at All Satisfied) and in the telehealth group were 34.8%, 59.9%, and 5.3%, respectively (frequencies to not add to exactly 100% due to rounding). Chi-squared analysis with continuity correction was used to determine if there were differences in the observed frequencies between groups (telehealth versus no telehealth) across the 3 levels of the Patient Satisfaction question relative to the expected frequencies with each of the imputations, and p values were combined using the Enders (2001) method.|||0.04
72335796|NCT01960998|144194843|SUPERIORITY|||||||0.67||||||P values not adjusted for multiple comparisons|t-test, 2 sided||||Mean values for the telehealth and no telehealth groups on the Estimated Percent Improvement (EPI) are presented above. Multiple imputation was performed to account for missing data, using the Multiple Imputation via Chained Equations (MICE) package in R. Across 10 imputations, the mean EPI score in the no telehealth group at 6 months was 65.1 (standard deviation 34.5) and in the telehealth group was 69.6 (SD 29.6). Two-sample t-tests were performed with each of the 10 imputations, and p values were combined using the Rubin-Licht method.|||0.67
72335797|NCT01960998|144194844|SUPERIORITY|||||||0.65|||||||Chi-squared, Corrected||||Frequencies for the telehealth and no telehealth groups on the Global Perception of Improvement (GPI) question are presented above. Multiple imputation was performed to account for missing data, using the Multiple Imputation via Chained Equations (MICE) package in R. Across 10 imputations, the mean frequencies for the no telehealth group at 6 months were 46.3% (Much Better), 30.7% (Better), 16.7% (About the Same), 2.3% (Worse), and 3.9% (Much Worse) and in the telehealth group were 38.3%, 41.1%, 15.3%, 2.9%, and 2.5%, respectively (frequencies to not add to exactly 100% due to rounding). Chi-squared analysis with continuity correction was used to determine if there were differences in the observed frequencies between groups (telehealth versus no telehealth) across the 5 levels of the Global Perception of Improvement question relative to the expected frequencies with each of the imputations, and p values were combined using the Enders (2001) method.|||0.65
72335798|NCT01960998|144194845|SUPERIORITY|||||||0.37||||||P values were not corrected for multiple comparisons|Chi-squared, Corrected||||"Frequencies for the telehealth and no telehealth groups on the How Disturbing is the Urine Leakage? question are presented above. Multiple imputation was performed to account for missing data, using the Multiple Imputation via Chained Equations (MICE) package in R. Across 10 imputations, the mean frequencies for the no telehealth group at 6 months were 43.5% (Not at All), 44.4% (Somewhat), and 12.1% (Extremely) and in the telehealth group were 38.9%, 53.2%, and 7.9% respectively. Chi-squared analysis with continuity correction was used to determine if there were differences in the observed frequencies between groups (telehealth versus no telehealth) across the 3 levels of the How Disturbing is the Urine Leakage? question relative to the expected frequencies with each of the imputations, and p values were combined using the Enders (2001) method."|||0.37
72335799|NCT01960998|144194846|SUPERIORITY|||||||0.63||||||P values were not adjusted for multiple comparisons|Chi-squared, Corrected||||Frequencies for the telehealth and no telehealth groups on the Activity Restriction question relative to the expected frequencies question are presented above. Multiple imputation was performed to account for missing data, using the Multiple Imputation via Chained Equations (MICE) package in R. Across 10 imputations, the mean frequencies for the no telehealth group at 6 months were 51.0% (Not at all), 36.5% (Some of the time), 7.2% (Most of the time), and 5.3% (All of the time) and in the telehealth group were 56.5%, 33.5%, 4.2%, and 5.8% respectively (frequencies to not add to exactly 100% due to rounding). Chi-squared analysis with continuity correction was used to determine if there were differences in the observed frequencies between groups (telehealth versus no telehealth) across the 4 levels of the Activity Restriction question relative to the expected frequencies with each of the imputations, and p values were combined using the Enders (2001) method.|||0.63
72335800|NCT01960998|144194847|SUPERIORITY|||||||0.71||||||P values not adjusted for multiple comparisons|Chi-squared, Corrected||||Frequencies for the telehealth and no telehealth groups on the Return to Work question relative to the expected frequencies question are presented above. Multiple imputation was performed to account for missing data, using the Multiple Imputation via Chained Equations (MICE) package in R. Across 10 imputations, the mean frequencies for the no telehealth group at 6 months were 52.3% (Yes), 5.0% (No, not yet recovered from surgery), 1.9% (No, other reason), and 40.7% (Retired or disabled) and in the telehealth group were 62.3%, 3.5%, 0.8%, and 33.5% respectively (frequencies to not add to exactly 100% due to rounding). Chi-squared analysis with continuity correction was used to determine if there were differences in the observed frequencies between groups (telehealth versus no telehealth) across the 4 levels of the Return to Work question relative to the expected frequencies with each of the imputations, and p values were combined using the Enders (2001) method.|||0.71
72335801|NCT01960998|144194848|SUPERIORITY|||||||0.41||||||P values not corrected for multiple comparisons|Chi-squared, Corrected||||Frequencies for the telehealth and no telehealth groups on the Resumption of Normal Activities question relative to the expected frequencies question are presented above. Multiple imputation was performed to account for missing data, using the Multiple Imputation via Chained Equations (MICE) package in R. Across 10 imputations, the mean frequencies for the no telehealth group at 6 months were 7.4% (None), 29.8% (Some), 62.8% (All) and in the telehealth group were 4.9%, 23.0%, and 72.2% respectively (frequencies to not add to exactly 100% due to rounding). Chi-squared analysis with continuity correction was used to determine if there were differences in the observed frequencies between groups (telehealth versus no telehealth) across the 3 levels of the Resumption of Normal Activities question relative to the expected frequencies with each of the imputations, and p values were combined using the Enders (2001) method.|||0.41
72335802|NCT00759356|144194849|NON_INFERIORITY_OR_EQUIVALENCE|The 90% confidence intervals for the ratios (test/reference) of the least squares means of the non-transformed parameters Cmax, AUClast, AUCinf, Tmax, λz, and T1/2, were calculated.|Mean ratio|109.8||||||90.0|95.3|126.5|||ANOVA|||||126.5|95.3|
72335803|NCT00759356|144194851|NON_INFERIORITY_OR_EQUIVALENCE|The 90% confidence intervals for the ratios (test/reference) of the least squares means of the non-transformed parameters Cmax, AUClast, AUCinf, Tmax, λz, and T1/2, were calculated.|mean ratio|101.5||||||90.0|95.6|107.9|||ANOVA|||||107.9|95.6|
72335804|NCT00759356|144194852|NON_INFERIORITY_OR_EQUIVALENCE|The 90% confidence intervals for the ratios (test/reference) of the least squares means of the non-transformed parameters Cmax, AUClast, AUCinf, Tmax, λz, and T1/2, were calculated.|mean ratio|101.7||||||90.0|95.9|107.9|||ANOVA|log-transformation||||107.9|95.9|
72335805|NCT00812006|144194877|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||Generalized Linear Mixed Model|An unstructured covariance matrix was used to model the correlation among repeated measurements within a patient.||||||<0.001
72335806|NCT00812006|144194878|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||Nominal p-value was adjusted under Benjamini and Hochberg's false discovery rate procedure for the multiple secondary endpoints at α=0.1 significance level.|Generalized Linear Mixed Model|A compound-symmetry covariance matrix was used to model the correlation among repeated measurements within a patient, due to a convergence issue.||||||<0.001
72335807|NCT00812006|144194879|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||Nominal p-value was adjusted under Benjamini and Hochberg's false discovery rate procedure for the multiple secondary endpoints at α=0.1 significance level.|Generalized Linear Mixed Model|An unstructured covariance matrix was used to model the correlation among repeated measurements within a patient.||||||<0.001
72335808|NCT00812006|144194880|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||Nominal p-value was adjusted under Benjamini and Hochberg's falsediscovery rate procedure for the multiple secondary endpoints at α=0.1 significance level.|Generalized Linear Mixed Model|An unstructured covariance matrix was used to model the correlation among repeated measurements within a patient.||||||<0.001
72335809|NCT00812006|144194881|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||Nominal p-value was adjusted under Benjamini and Hochberg's false discovery rate procedure for the multiple secondary endpoints at α=0.1 significance level.|Generalized Linear Mixed Model|A compound-symmetry covariance matrix was used to model the correlation among repeated measurements within a patient, due to a convergence issue.||||||<0.001
72335810|NCT01686750|144194884|SUPERIORITY||Risk Ratio (RR)|1.31||||0.09|TWO_SIDED|95.0|0.95|1.81|||Prevalence ratio||Therefore, the exponentiated coefficients for intervention status represent the prevalence ratio with 95% confidence interval (CI) and are interpreted as the relative percentage difference in the outcome associated with the intervention.|We compared the sampling-weighted prevalence of outcomes at Integrated Care Centers (ICCs) and usual care from the evaluation survey. We used linear regression models that had terms for intervention status (integrated care vs usual care), stratum (PWID and MSM), and the baseline proportion of the outcome being assessed. Site-level proportions from both evaluation and baseline respondent-driven sampling were log transformed before being entered into the regression model.||1.81|0.95|0.09
72335811|NCT01686750|144194885|SUPERIORITY||Risk Ratio (RR)|1.08|||||TWO_SIDED|95.0|0.8|1.5||||||||1.50|0.80|
72335812|NCT01686750|144194886|SUPERIORITY||Risk Ratio (RR)|1.05|||||TWO_SIDED|95.0|0.61|1.81||||||||1.81|0.61|
72335813|NCT01686750|144194887|SUPERIORITY||Risk Ratio (RR)|1.36|||||TWO_SIDED|95.0|0.77|2.41||||||||2.41|0.77|
72335814|NCT01686750|144194889|SUPERIORITY||Risk Ratio (RR)|0.91|||||TWO_SIDED|95.0|0.65|1.28||||||||1.28|0.65|
72426404|NCT01702428|144364803|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|For each pair-wise comparison, the 2-sided 95% CI on the lot ratio should be within the \[0.67;1.5\] margin for antibodies to measles.|Adjusted GMC ratio|1.01|||||TWO_SIDED|95.0|0.94|1.09|||ANOVA|95% CI for GMC of each INV\_MMR lots pair was computed using ANOVA (3 INV\_MMR lot groups \& country as fixed effects) on log-transformed concentrations.||Adjusted GMC ratio (INV\_MMR\_L3 Group divided by INV\_MMR\_L2 Group) for antibodies to measles virus at Day 42.||1.09|0.94|
72335815|NCT01686750|144194891|SUPERIORITY||Risk Ratio, log|1.44|||||TWO_SIDED|95.0|0.42|4.93||||||||4.93|0.42|
72335816|NCT01686750|144194892|SUPERIORITY||Risk Ratio, log|1.87|||||TWO_SIDED|95.0|0.49|7.16||||||||7.16|0.49|
72335817|NCT01686750|144194893|SUPERIORITY||Risk Ratio (RR)|0.91|||||TWO_SIDED|95.0|0.53|1.56||||||||1.56|0.53|
72335818|NCT01686750|144194894|SUPERIORITY||Mean Difference (Final Values)|0.03|||||TWO_SIDED|95.0|-4.2|4.2||||||||4.2|-4.2|
72335819|NCT01686750|144194896|SUPERIORITY||Risk Ratio (RR)|0.84|||||TWO_SIDED|95.0|0.47|1.52||||||||1.52|0.47|
72335820|NCT01686750|144194898|SUPERIORITY||Mean Difference (Final Values)|-1.8|||||TWO_SIDED|95.0|-3.0|-0.6||||||||-0.6|-3.0|
72335821|NCT01686750|144194899|SUPERIORITY||Risk Ratio (RR)|0.93|||||TWO_SIDED|95.0|0.64|1.36||||||||1.36|0.64|
72335822|NCT01939002|144194900|SUPERIORITY_OR_OTHER||||||<|0.0001||||||1-sample Chi-square test comparing to Null hypotheses at 25%.|Chi-squared|||||||<0.0001
72335823|NCT01939002|144194901|SUPERIORITY_OR_OTHER|||||||0.2037||||||Chi-square test between 2 treatment arms.|Chi-squared|||||||0.2037
72335824|NCT01939002|144194903|SUPERIORITY_OR_OTHER|||||||1|||||||McNemar|McNemar tests the null hypothesis of no difference in FLS between 4WRI and F8W.||||||1.00
72335825|NCT01939002|144194903|SUPERIORITY_OR_OTHER|||||||0.5078|||||||McNemar|||||||0.5078
72335826|NCT01939002|144194903|SUPERIORITY_OR_OTHER|||||||0.5811|||||||McNemar|||||||0.5811
72335827|NCT01939002|144194904|SUPERIORITY_OR_OTHER|||||||0.0525|||||||McNemar|||||||0.0525
72335828|NCT01939002|144194904|SUPERIORITY_OR_OTHER|||||||0.0654|||||||McNemar|||||||0.0654
72335829|NCT01939002|144194904|SUPERIORITY_OR_OTHER|||||||0.5488|||||||McNemar|||||||0.5488
72335830|NCT01939002|144194905|SUPERIORITY_OR_OTHER|||||||0.0945|||||||paired t-test within 1 arm|||||||0.0945
72335831|NCT01939002|144194905|SUPERIORITY_OR_OTHER|||||||0.8246|||||||paired t-test within 1 arm|||||||0.8246
72335832|NCT01939002|144194905|SUPERIORITY_OR_OTHER|||||||0.2533|||||||paired t-test within 1 arm|||||||0.2533
72335833|NCT01939002|144194905|SUPERIORITY_OR_OTHER|||||||0.1631|||||||2-sample t-test between 2 arms|||||||0.1631
72335834|NCT01939002|144194906|SUPERIORITY_OR_OTHER|||||||0.3189|||||||paired t-test within 1 arm|||||||0.3189
72335835|NCT01939002|144194906|SUPERIORITY_OR_OTHER|||||||0.3582|||||||paired t-test within 1 arm|||||||0.3582
72335836|NCT01939002|144194906|SUPERIORITY_OR_OTHER|||||||0.8484|||||||paired t-test within 1 arm|||||||0.8484
72335837|NCT01939002|144194906|SUPERIORITY_OR_OTHER|||||||0.1771|||||||2-sample t-test between 2 arms|||||||0.1771
72335838|NCT01939002|144194907|SUPERIORITY_OR_OTHER|||||||0.0009|||||||paired t-test within 1 arm|||||||0.0009
72335839|NCT01939002|144194907|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||paired t-test within 1 arm|||||||<0.0001
72335840|NCT01939002|144194907|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||paired t-test within 1 arm|||||||<0.0001
72335841|NCT01939002|144194907|SUPERIORITY_OR_OTHER|||||||0.3792|||||||2-sample t-test between 2 arms|||||||0.3792
72335842|NCT01939002|144194908|SUPERIORITY_OR_OTHER|||||||0.0019|||||||paired t-test within 1 arm|||||||0.0019
72335843|NCT01939002|144194908|SUPERIORITY_OR_OTHER|||||||0.0009|||||||paired t-test within 1 arm|||||||0.0009
72335844|NCT01939002|144194908|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||paired t-test within 1 arm|||||||<0.0001
72335845|NCT01939002|144194909|SUPERIORITY_OR_OTHER|||||||0.0105|||||||paired t-test within 1 arm|||||||0.0105
72335846|NCT01939002|144194909|SUPERIORITY_OR_OTHER|||||||0.0789|||||||paired t-test within 1 arm|||||||0.0789
72335847|NCT01939002|144194909|SUPERIORITY_OR_OTHER|||||||0.0027|||||||paired t-test within 1 arm|||||||0.0027
72335848|NCT01939002|144194909|SUPERIORITY_OR_OTHER|||||||0.838|||||||2-sample t-test between 2 arms|||||||0.8380
72335849|NCT01939002|144194910|SUPERIORITY_OR_OTHER|||||||0.1407|||||||paired t-test within 1 arm|||||||0.1407
72335850|NCT01939002|144194910|SUPERIORITY_OR_OTHER|||||||0.7805|||||||paired t-test within 1 arm|||||||0.7805
72335851|NCT01939002|144194910|SUPERIORITY_OR_OTHER|||||||0.2186|||||||paired t-test within 1 arm|||||||0.2186
72335852|NCT01939002|144194910|SUPERIORITY_OR_OTHER|||||||0.4234|||||||2-sample t-test between 2 arms|||||||0.4234
72335853|NCT01939002|144194911|SUPERIORITY_OR_OTHER|||||||0.009|||||||paired t-test within 1 arm|||||||0.0090
72335854|NCT01939002|144194911|SUPERIORITY_OR_OTHER|||||||0.0075|||||||paired t-test within 1 arm|||||||0.0075
72335855|NCT01939002|144194911|SUPERIORITY_OR_OTHER|||||||0.0002|||||||paired t-test within 1 arm|||||||0.0002
72335856|NCT01939002|144194911|SUPERIORITY_OR_OTHER|||||||0.7497|||||||2-sample t-test between 2 arms|||||||0.7497
72335857|NCT01939002|144194912|SUPERIORITY_OR_OTHER|||||||0.0545|||||||paired t-test within 1 arm|||||||0.0545
72335858|NCT01939002|144194912|SUPERIORITY_OR_OTHER|||||||0.3377|||||||paired t-test within 1 arm|||||||0.3377
72335859|NCT01939002|144194912|SUPERIORITY_OR_OTHER|||||||0.0391|||||||paired t-test within 1 arm|||||||0.0391
72335860|NCT01939002|144194912|SUPERIORITY_OR_OTHER|||||||0.4861|||||||2-sample t-test between 2 arms|||||||0.4861
72335861|NCT01939002|144194913|SUPERIORITY_OR_OTHER|||||||0.0834|||||||Fisher Exact|||first 8 weeks||||0.0834
72335862|NCT01939002|144194913|SUPERIORITY_OR_OTHER|||||||0.0767|||||||Fisher Exact|||Weeks 0-2||||0.0767
72335863|NCT01939002|144194913|SUPERIORITY_OR_OTHER|||||||0.732|||||||Fisher Exact|||Weeks 3-4||||0.7320
72335864|NCT01939002|144194913|SUPERIORITY_OR_OTHER|||||||0.5008|||||||Fisher Exact|||Weeks 5-6||||0.5008
72335865|NCT01939002|144194913|SUPERIORITY_OR_OTHER|||||||0.6422|||||||Fisher Exact|||Weeks 7-8||||0.6422
72335866|NCT01939002|144194914|SUPERIORITY_OR_OTHER|||||||0.2123|||||||paired t-test within 1 arm|||change at Week 4||||0.2123
72335867|NCT01939002|144194914|SUPERIORITY_OR_OTHER|||||||0.5834|||||||paired t-test within 1 arm|||change at Week 12||||0.5834
72335868|NCT01939002|144194914|SUPERIORITY_OR_OTHER|||||||0.8723|||||||paired t-test within 1 arm|||change at Week 24||||0.8723
72335869|NCT01939002|144194914|SUPERIORITY_OR_OTHER|||||||0.4173|||||||paired t-test within 1 arm|||change at Week 36||||0.4173
72335870|NCT01939002|144194914|SUPERIORITY_OR_OTHER|||||||0.2267|||||||paired t-test within 1 arm|||change at Week 48||||0.2267
72335871|NCT01939002|144194914|SUPERIORITY_OR_OTHER|||||||0.0171|||||||paired t-test within 1 arm|||change at Early Term||||0.0171
72335872|NCT01939002|144194915|SUPERIORITY_OR_OTHER|||||||0.0001|||||||paired t-test within 1 arm|||change at Week 4||||0.0001
72335873|NCT01939002|144194915|SUPERIORITY_OR_OTHER|||||||0.0007|||||||paired t-test within 1 arm|||change at Week 12||||0.0007
72335874|NCT01939002|144194915|SUPERIORITY_OR_OTHER|||||||0.0365|||||||paired t-test within 1 arm|||change at Week 24||||0.0365
72335875|NCT01939002|144194915|SUPERIORITY_OR_OTHER|||||||0.0197|||||||paired t-test within 1 arm|||change at Week 36||||0.0197
72335876|NCT01939002|144194915|SUPERIORITY_OR_OTHER|||||||0.4031|||||||paired t-test within 1 arm|||change at Week 48||||0.4031
72335877|NCT01939002|144194915|SUPERIORITY_OR_OTHER|||||||0.006|||||||paired t-test within 1 arm|||change at Early Termination||||0.0060
72335878|NCT01939002|144194916|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||paired t-test within 1 arm|||change at Week 4||||<0.0001
72335879|NCT01939002|144194916|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||paired t-test within 1 arm|||change at Week 12||||<0.0001
72335880|NCT01939002|144194916|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||paired t-test within 1 arm|||change at Week 24||||<0.0001
72335881|NCT01939002|144194916|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||paired t-test within 1 arm|||change at Week 36||||<0.0001
72335882|NCT01939002|144194916|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||paired t-test within 1 arm|||change at Week 48||||<0.0001
72335883|NCT01939002|144194916|SUPERIORITY_OR_OTHER|||||||0.1789|||||||paired t-test within 1 arm|||change at Early Termination||||0.1789
72335884|NCT01939002|144194916|SUPERIORITY_OR_OTHER|||||||0.2248||||||p-value on slope is based on general linear model with repeat measures over all visits.|general linear model|||||||0.2248
72335885|NCT01939002|144194917|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||paired t-test within 1 arm|||change at Week 4||||<0.0001
72335886|NCT01939002|144194917|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||paired t-test within 1 arm|||change at Week 12||||<0.0001
72335887|NCT01939002|144194917|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||paired t-test within 1 arm|||change at Week 24||||<0.0001
72335888|NCT01939002|144194917|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||paired t-test within 1 arm|||change at Week 36||||<0.0001
72335889|NCT01939002|144194917|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||paired t-test within 1 arm|||change at Week 48||||<0.0001
72335890|NCT01939002|144194917|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||paired t-test within 1 arm|||change at Early Termination||||<0.0001
72335891|NCT01939002|144194917|SUPERIORITY_OR_OTHER||||||<|0.0001||||||p-value on slope is based on general linear model with repeat measures over all visits.|general linear model|||||||<0.0001
72335892|NCT01939002|144194918|SUPERIORITY_OR_OTHER|||||||0.7012|||||||paired t-test within 1 arm|||change at Week 4||||0.7012
72335893|NCT01939002|144194918|SUPERIORITY_OR_OTHER|||||||0.0548|||||||paired t-test within 1 arm|||change at Week 4||||0.0548
72335894|NCT01939002|144194918|SUPERIORITY_OR_OTHER|||||||0.0782|||||||2-sample t-test between 2 arms|||change at Week 4||||0.0782
72335895|NCT01939002|144194919|SUPERIORITY_OR_OTHER|||||||0.0006|||||||paired t-test within 1 arm|||change at Week 4||||0.0006
72335896|NCT01939002|144194919|SUPERIORITY_OR_OTHER|||||||0.0792|||||||paired t-test within 1 arm|||change at Week 4||||0.0792
72335897|NCT01939002|144194919|SUPERIORITY_OR_OTHER|||||||0.0961|||||||2-sample t-test between 2 arms|||change at Week 4||||0.0961
72335898|NCT01939002|144194920|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||paired t-test within 1 arm|||change at Week 4||||<0.0001
72335899|NCT01939002|144194920|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||paired t-test within 1 arm|||change at Week 4||||<0.0001
72335900|NCT01939002|144194920|SUPERIORITY_OR_OTHER|||||||0.4973|||||||2-sample t-test between 2 arms|||change at Week 4||||0.4973
72335901|NCT01939002|144194921|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||paired t-test within 1 arm|||change at Week 4||||<0.0001
72335902|NCT01939002|144194921|SUPERIORITY_OR_OTHER|||||||0.0464|||||||paired t-test within 1 arm|||change at Week 4||||0.0464
72335903|NCT01939002|144194921|SUPERIORITY_OR_OTHER|||||||0.1905|||||||2-sample t-test between 2 arms|||change at Week 4||||0.1905
72335904|NCT01939002|144194922|SUPERIORITY_OR_OTHER|||||||0.6569|||||||paired t-test within 1 arm|||change at Week 12||||0.6569
72335905|NCT01939002|144194922|SUPERIORITY_OR_OTHER|||||||0.1584|||||||paired t-test within 1 arm|||change at Week 24||||0.1584
72335906|NCT01939002|144194922|SUPERIORITY_OR_OTHER|||||||0.5106|||||||paired t-test within 1 arm|||change at Week 36||||0.5106
72335907|NCT01939002|144194922|SUPERIORITY_OR_OTHER|||||||0.5927|||||||paired t-test within 1 arm|||change at Week 48||||0.5927
72335908|NCT01939002|144194922|SUPERIORITY_OR_OTHER|||||||0.384|||||||paired t-test within 1 arm|||change at Early Termination||||0.3840
72335909|NCT01939002|144194922|SUPERIORITY_OR_OTHER|||||||0.4182||||||p-value on slope is based on general linear model with repeat measures over all visits.|general linear model|||||||0.4182
72335910|NCT01939002|144194923|SUPERIORITY_OR_OTHER|||||||0.2588|||||||paired t-test within 1 arm|||change at Week 12||||0.2588
72335911|NCT01939002|144194923|SUPERIORITY_OR_OTHER|||||||0.1092|||||||paired t-test within 1 arm|||change at Week 24||||0.1092
72335912|NCT01939002|144194923|SUPERIORITY_OR_OTHER|||||||1|||||||paired t-test within 1 arm|||change at Week 36||||1.0000
72335913|NCT01939002|144194923|SUPERIORITY_OR_OTHER|||||||0.219|||||||paired t-test within 1 arm|||change at Week 48||||0.2190
72335914|NCT01939002|144194923|SUPERIORITY_OR_OTHER|||||||0.6402||||||p-value on slope is based on general linear model with repeat measures over all visits.|general linear model|||||||0.6402
72335915|NCT01939002|144194924|SUPERIORITY_OR_OTHER|||||||0.4821|||||||paired t-test within 1 arm|||change at Week 12||||0.4821
72335916|NCT01939002|144194924|SUPERIORITY_OR_OTHER|||||||0.5298|||||||paired t-test within 1 arm|||change at Week 24||||0.5298
72335917|NCT01939002|144194924|SUPERIORITY_OR_OTHER|||||||0.1584|||||||paired t-test within 1 arm|||change at Week 36||||0.1584
72335918|NCT01939002|144194924|SUPERIORITY_OR_OTHER|||||||0.2547|||||||paired t-test within 1 arm|||change at Week 48||||0.2547
72335919|NCT01939002|144194924|SUPERIORITY_OR_OTHER|||||||0.0824|||||||paired t-test within 1 arm|||change at Early Termination||||0.0824
72335920|NCT01939002|144194924|SUPERIORITY_OR_OTHER|||||||0.3148||||||p-value on slope is based GLM with repeat measures over all visits.|general linear model|||||||0.3148
72335921|NCT01939002|144194925|SUPERIORITY_OR_OTHER|||||||0.6508|||||||paired t-test within 1 arm|||change at Week 12||||0.6508
72335922|NCT01939002|144194925|SUPERIORITY_OR_OTHER|||||||0.0315|||||||paired t-test within 1 arm|||change at Week 48||||0.0315
72335923|NCT01939002|144194925|SUPERIORITY_OR_OTHER|||||||0.119|||||||paired t-test within 1 arm|||change at Early Termination||||0.1190
72335924|NCT01939002|144194925|SUPERIORITY_OR_OTHER|||||||0.152||||||p-value on slope is based GLM with repeat measures over all visits.|general linear model|||||||0.1520
72335925|NCT01939002|144194927|SUPERIORITY_OR_OTHER|||||||0.0049|||||||paired t-test within 1 arm|||Change from 4WRI to L4W||||0.0049
72335926|NCT01939002|144194927|SUPERIORITY_OR_OTHER|||||||0.223|||||||paired t-test within 1 arm|||Change from 4WRI to L4W||||0.2230
72335927|NCT01939002|144194927|SUPERIORITY_OR_OTHER|||||||0.0031|||||||paired t-test within 1 arm|||Change from 4WRI to L4W||||0.0031
72335928|NCT01939002|144194927|SUPERIORITY_OR_OTHER|||||||0.1624|||||||2-sample t-test between 2 arms|||Change from 4WRI to L4W||||0.1624
72426405|NCT01702428|144364804|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|For each pair-wise comparison, the 2-sided 95% CI on the lot difference in seroresponse rates should be within the \[-5%;5%\] margin for antibodies to mumps virus.|Difference in seroresponse rate|0.02|||||TWO_SIDED|95.0|-1.05|1.09|||||Asymptotic standardized 95% CI for the pair-wise differences in seroresponse.|Difference between groups (INV\_MMR\_L1 Group minus INV\_MMR\_L2 Group) in percentage of subjects with anti-mumps antibody concentration ≥10 EU/mL.||1.09|-1.05|
72426406|NCT01702428|144364804|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|For each pair-wise comparison, the 2-sided 95% CI on the lot difference in seroresponse rates should be within the \[-5%;5%\] margin for antibodies to mumps virus.|Difference in seroresponse rate|0.63|||||TWO_SIDED|95.0|-0.5|1.81|||||Asymptotic standardized 95% CI for the pair-wise differences in seroresponse.|Difference between groups (INV\_MMR\_L1 Group minus INV\_MMR\_L3 Group) in percentage of subjects with anti-mumps antibody concentration ≥10 EU/mL.||1.81|-0.50|
72426407|NCT01702428|144364804|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|For each pair-wise comparison, the 2-sided 95% CI on the lot difference in seroresponse rates should be within the \[-5%;5%\] margin for antibodies to mumps virus.|Difference in seroresponse rate|0.61|||||TWO_SIDED|95.0|-0.53|1.79|||||Asymptotic standardized 95% CI for the pair-wise differences in seroresponse.|Difference between groups (INV\_MMR\_L2 Group minus INV\_MMR\_L3 Group) in percentage of subjects with anti-mumps antibody concentration ≥10 EU/mL.||1.79|-0.53|
72426408|NCT01702428|144364805|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|For each pair-wise comparison, the 2-sided 95% CI on the lot ratio should be within the \[0.67;1.5\] margin for antibodies to mumps.|Adjusted GMC ratio|0.93|||||TWO_SIDED|95.0|0.87|1.0|||ANOVA|95% CI for GMC of each INV\_MMR lots pair was computed using ANOVA (3 INV\_MMR lot groups \& country as fixed effects) on log-transformed concentrations.||Adjusted GMC ratio (INV\_MMR\_L1 Group divided by INV\_MMR\_L2 Group) for antibodies to mumps virus at Day 42.||1.00|0.87|
72426409|NCT01702428|144364805|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|For each pair-wise comparison, the 2-sided 95% CI on the lot ratio should be within the \[0.67;1.5\] margin for antibodies to mumps.|Adjusted GMC ratio|1.04|||||TWO_SIDED|95.0|0.97|1.11|||ANOVA|95% CI for GMC of each INV\_MMR lots pair was computed using ANOVA (3 INV\_MMR lot groups \& country as fixed effects) on log-transformed concentrations.||Adjusted GMC ratio (INV\_MMR\_L1 Group divided by INV\_MMR\_L3 Group) for antibodies to mumps virus at Day 42.||1.11|0.97|
72426410|NCT01702428|144364805|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|For each pair-wise comparison, the 2-sided 95% CI on the lot ratio should be within the \[0.67;1.5\] margin for antibodies to mumps.|Adjusted GMC ratio|1.07|||||TWO_SIDED|95.0|1.0|1.15|||ANOVA|95% CI for GMC of each INV\_MMR lots pair was computed using ANOVA (3 INV\_MMR lot groups \& country as fixed effects) on log-transformed concentrations.||Adjusted GMC ratio (INV\_MMR\_L2 Group divided by INV\_MMR\_L1 Group) for antibodies to mumps virus at Day 42.||1.15|1.00|
72426411|NCT01702428|144364805|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|For each pair-wise comparison, the 2-sided 95% CI on the lot ratio should be within the \[0.67;1.5\] margin for antibodies to mumps.|Adjusted GMC ratio|1.11|||||TWO_SIDED|95.0|1.04|1.19|||ANOVA|95% CI for GMC of each INV\_MMR lots pair was computed using ANOVA (3 INV\_MMR lot groups \& country as fixed effects) on log-transformed concentrations.||Adjusted GMC ratio (INV\_MMR\_L2 Group divided by INV\_MMR\_L3 Group) for antibodies to mumps virus at Day 42.||1.19|1.04|
72426412|NCT01702428|144364805|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|For each pair-wise comparison, the 2-sided 95% CI on the lot ratio should be within the \[0.67;1.5\] margin for antibodies to mumps.|Adjusted GMC ratio|0.96|||||TWO_SIDED|95.0|0.9|1.03|||ANOVA|95% CI for GMC of each INV\_MMR lots pair was computed using ANOVA (3 INV\_MMR lot groups \& country as fixed effects) on log-transformed concentrations.||Adjusted GMC ratio (INV\_MMR\_L3 Group divided by INV\_MMR\_L1 Group) for antibodies to mumps virus at Day 42.||1.03|0.90|
72426413|NCT01702428|144364805|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|For each pair-wise comparison, the 2-sided 95% CI on the lot ratio should be within the \[0.67;1.5\] margin for antibodies to mumps.|Adjusted GMC ratio|0.9|||||TWO_SIDED|95.0|0.84|0.96|||ANOVA|95% CI for GMC of each INV\_MMR lots pair was computed using ANOVA (3 INV\_MMR lot groups \& country as fixed effects) on log-transformed concentrations.||Adjusted GMC ratio (INV\_MMR\_L3 Group divided by INV\_MMR\_L2 Group) for antibodies to mumps virus at Day 42.||0.96|0.84|
72426414|NCT01702428|144364806|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|For each pair-wise comparison, the 2-sided 95% CI on the lot difference in seroresponse rates should be within the \[-5%;5%\] margin for antibodies to rubella virus.|Difference in seroresponse rate|0.14|||||TWO_SIDED|95.0|-1.3|1.58|||||Asymptotic standardized 95% CI for the pair-wise differences in seroresponse.|Difference between groups (INV\_MMR\_L1 Group minus INV\_MMR\_L2 Group) in percentage of subjects with anti-rubella antibody concentration ≥10 IU/mL.||1.58|-1.3|
72426415|NCT01702428|144364806|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|For each pair-wise comparison, the 2-sided 95% CI on the lot difference in seroresponse rates should be within the \[-5%;5%\] margin for antibodies to rubella virus.|Difference in seroresponse rate|-0.49|||||TWO_SIDED|95.0|-1.86|0.86|||||Asymptotic standardized 95% CI for the pair-wise differences in seroresponse.|Difference between groups (INV\_MMR\_L1 Group minus INV\_MMR\_L3 Group) in percentage of subjects with anti-rubella antibody concentration ≥10 IU/mL.||0.86|-1.86|
72426416|NCT01702428|144364806|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|For each pair-wise comparison, the 2-sided 95% CI on the lot difference in seroresponse rates should be within the \[-5%;5%\] margin for antibodies to rubella virus.|Difference in seroresponse rate|-0.62|||||TWO_SIDED|95.0|-2.02|0.74|||||Asymptotic standardized 95% CI for the pair-wise differences in seroresponse.|Difference between groups (INV\_MMR\_L2 Group minus INV\_MMR\_L3 Group) in percentage of subjects with anti-rubella antibody concentration ≥10 IU/mL.||0.74|-2.02|
72426417|NCT01702428|144364807|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|For each pair-wise comparison, the 2-sided 95% CI on the lot ratio should be within the \[0.67;1.5\] margin for antibodies to measles.|Adjusted GMC ratio|1.08|||||TWO_SIDED|95.0|1.01|1.15|||ANOVA|95% CI for GMC of each INV\_MMR lots pair was computed using ANOVA (3 INV\_MMR lot groups \& country as fixed effects) on log-transformed concentrations.||"Adjusted GMC ratio (INV\_MMR\_L1 Group divided by INV\_MMR\_L2 Group) for antibodies to rubella virus at Day 42.~."||1.15|1.01|
72335929|NCT00098748|144194937|NON_INFERIORITY_OR_EQUIVALENCE|For hypothesis of superiority, if upper bound of 97.5% confidence interval (CI) of TX difference was \<0 log10 copies/mL, it was concluded that MVC regimen was superior to PBO meaning that MVC added to Optimized Background Therapy (OBT) provides an additional reduction in plasma HIV-1 RNA compared to OBT alone. If superiority could not be concluded, then a hypothesis of noninferiority was tested. If upper bound of CI is \<0.25 log10 copies/mL, noninferiority of MVC regimen to placebo was claimed.|Least squares mean|0.055|STANDARD_ERROR_OF_MEAN|0.2575|||TWO_SIDED|97.5|-0.528|0.638|||ANCOVA|TX difference adjusted for randomization strata. Bonferroni adjustment for multiple comparisons by use of 2-sided 97.5% CI to maintain alpha=0.05.|Negative values for change from baseline=benefit of TX; negative values for MVC versus (vs) PBO=advantage of MVC.|Maraviroc (MVC) QD versus placebo (PBO) treatment (TX) difference at Week 24. If upper bound of 97.5% confidence interval is \<0, it is concluded that dose is superior to PBO. If upper bound is \<0.25, it is concluded that MVC is non-inferior to PBO. Assumption: 79% of subjects are dual-tropic; total N=192 needed to be randomized to get N=150 dual-tropic. Standard deviation=0.8 with 2-sided p-value=0.025: 80% power for TX difference of 0.5 for change from baseline in log10-transformed viral load.||0.638|-0.528|
72335930|NCT00098748|144194937|SUPERIORITY_OR_OTHER||Least squares mean|-0.232|STANDARD_ERROR_OF_MEAN|0.2637|||TWO_SIDED|97.5|-0.829|0.364|||ANCOVA|TX difference adjusted for randomization strata. Bonferroni adjustment for multiple comparisons by use of 2-sided 97.5% CI to maintain alpha=0.05.|Negative values for change from baseline=benefit of TX; negative values for MVC vs PBO=advantage of MVC.|MVC BID vs PBO treatment difference at Week 24.||0.364|-0.829|
72335931|NCT00098748|144194937|SUPERIORITY_OR_OTHER||Least squares mean|0.229|STANDARD_ERROR_OF_MEAN|0.2567|||TWO_SIDED|97.5|-0.351|0.81|||ANCOVA|TX difference adjusted for randomization strata. Bonferroni adjustment for multiple comparisons by use of 2-sided 97.5% CI to maintain alpha=0.05.|Negative values for change from baseline=benefit of TX; negative values for MVC vs PBO=advantage of MVC.|MVC QD vs PBO treatment difference at Week 48.||0.810|-0.351|
72335932|NCT00098748|144194937|SUPERIORITY_OR_OTHER||Least squares mean|-0.261|STANDARD_ERROR_OF_MEAN|0.2628|||TWO_SIDED|97.5|-0.856|0.333|||ANCOVA|TX difference adjusted for randomization strata. Bonferroni adjustment for multiple comparisons by use of 2-sided 97.5% CI to maintain alpha=0.05.|Negative values for change from baseline=benefit of TX; negative values for MVC vs PBO=advantage of MVC.|MVC BID vs PBO treatment difference at Week 48.||0.333|-0.856|
72335933|NCT00098748|144194938|SUPERIORITY_OR_OTHER||difference in proportions|0.03|||||TWO_SIDED|95.0|-0.12|0.18|||||The TX difference is weighted (by inverse of the variance) difference in proportions adjusted for randomization strata. Positive values for TX difference favor MVC. CI estimated using the normal approximation to the binomial distribution.|MVC QD vs PBO treatment difference in proportions at Week 24.||0.18|-0.12|
72335934|NCT00098748|144194938|SUPERIORITY_OR_OTHER||difference in proportions|0.07|||||TWO_SIDED|95.0|-0.08|0.23|||||The TX difference is weighted (by inverse of the variance) difference in proportions adjusted for randomization strata. Positive values for TX difference favor MVC. CI estimated using the normal approximation to the binomial distribution.|MVC BID vs PBO treatment difference in proportions at Week 24.||0.23|-0.08|
72335935|NCT00098748|144194938|SUPERIORITY_OR_OTHER||difference in proportions|0.02|||||TWO_SIDED|95.0|-0.12|0.17|||||The TX difference is weighted (by inverse of the variance) difference in proportions adjusted for randomization strata. Positive values for TX difference favor MVC. CI estimated using the normal approximation to the binomial distribution.|MVC QD vs PBO treatment difference in proportions at Week 48.||0.17|-0.12|
72426418|NCT01702428|144364807|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|For each pair-wise comparison, the 2-sided 95% CI on the lot ratio should be within the \[0.67;1.5\] margin for antibodies to measles.|Adjusted GMC ratio|1.0|||||TWO_SIDED|95.0|0.94|1.07|||ANOVA|95% CI for GMC of each INV\_MMR lots pair was computed using ANOVA (3 INV\_MMR lot groups \& country as fixed effects) on log-transformed concentrations.||Adjusted GMC ratio (INV\_MMR\_L1 Group divided by INV\_MMR\_L3 Group) for antibodies to rubella virus at Day 42.||1.07|0.94|
72426419|NCT01702428|144364807|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|For each pair-wise comparison, the 2-sided 95% CI on the lot ratio should be within the \[0.67;1.5\] margin for antibodies to measles.|Adjusted GMC ratio|0.93|||||TWO_SIDED|95.0|0.87|0.99|||ANOVA|95% CI for GMC of each INV\_MMR lots pair was computed using ANOVA (3 INV\_MMR lot groups \& country as fixed effects) on log-transformed concentrations.||Adjusted GMC ratio (INV\_MMR\_L2 Group divided by INV\_MMR\_L1 Group) for antibodies to rubella virus at Day 42.||0.99|0.87|
72426420|NCT01702428|144364807|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|For each pair-wise comparison, the 2-sided 95% CI on the lot ratio should be within the \[0.67;1.5\] margin for antibodies to measles.|Adjusted GMC ratio|0.93|||||TWO_SIDED|95.0|0.87|0.99|||ANOVA|95% CI for GMC of each INV\_MMR lots pair was computed using ANOVA (3 INV\_MMR lot groups \& country as fixed effects) on log-transformed concentrations.||Adjusted GMC ratio (INV\_MMR\_L2 Group divided by INV\_MMR\_L3 Group) for antibodies to rubella virus at Day 42.||0.99|0.87|
72426421|NCT01702428|144364807|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|For each pair-wise comparison, the 2-sided 95% CI on the lot ratio should be within the \[0.67;1.5\] margin for antibodies to measles.|Adjusted GMC ratio|1.0|||||TWO_SIDED|95.0|0.93|1.07|||ANOVA|95% CI for GMC of each INV\_MMR lots pair was computed using ANOVA (3 INV\_MMR lot groups \& country as fixed effects) on log-transformed concentrations.||Adjusted GMC ratio (INV\_MMR\_L3 Group divided by INV\_MMR\_L1 Group) for antibodies to rubella virus at Day 42.||1.07|0.93|
72335936|NCT00098748|144194938|SUPERIORITY_OR_OTHER||difference in proportions|0.09|||||TWO_SIDED|95.0|-0.07|0.25|||||The TX difference is weighted (by inverse of the variance) difference in proportions adjusted for randomization strata. Positive values for TX difference favor MVC. CI estimated using the normal approximation to the binomial distribution.|MVC BID vs PBO treatment difference in proportions at Week 48.||0.25|-0.07|
72335937|NCT00098748|144194939|SUPERIORITY_OR_OTHER||difference in proportions|0.03|||||TWO_SIDED|95.0|-0.15|0.2|||||The TX difference is weighted (by inverse of the variance) difference in proportions adjusted for randomization strata. Positive values for TX difference favor MVC. CI estimated using the normal approximation to the binomial distribution.|MVC QD vs PBO treatment difference in proportions at Week 24.||0.20|-0.15|
72426422|NCT01702428|144364807|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|For each pair-wise comparison, the 2-sided 95% CI on the lot ratio should be within the \[0.67;1.5\] margin for antibodies to measles.|Adjusted GMC ratio|1.08|||||TWO_SIDED|95.0|1.01|1.15|||ANOVA|95% CI for GMC of each INV\_MMR lots pair was computed using ANOVA (3 INV\_MMR lot groups \& country as fixed effects) on log-transformed concentrations.||Adjusted GMC ratio (INV\_MMR\_L3 Group divided by INV\_MMR\_L2 Group) for antibodies to rubella virus at Day 42.||1.15|1.01|
72335938|NCT00098748|144194939|SUPERIORITY_OR_OTHER||difference in proportions|0.08|||||TWO_SIDED|95.0|-0.1|0.26|||||The TX difference is weighted (by inverse of the variance) difference in proportions adjusted for randomization strata. Positive values for TX difference favor MVC. CI estimated using the normal approximation to the binomial distribution.|MVC BID vs PBO treatment difference in proportions at Week 24.||0.26|-0.10|
72335939|NCT00098748|144194939|SUPERIORITY_OR_OTHER||difference in proportions|-0.06|||||TWO_SIDED|95.0|-0.22|0.1|||||The TX difference is weighted (by inverse of the variance) difference in proportions adjusted for randomization strata. Positive values for TX difference favor MVC. CI estimated using the normal approximation to the binomial distribution.|MVC QD vs PBO treatment difference in proportions at Week 48.||0.10|-0.22|
72335940|NCT00098748|144194939|SUPERIORITY_OR_OTHER||difference in proportions|0.11|||||TWO_SIDED|95.0|-0.07|0.28|||||The TX difference is weighted (by inverse of the variance) difference in proportions adjusted for randomization strata. Positive values for TX difference favor MVC. CI estimated using the normal approximation to the binomial distribution.|MVC BID vs PBO treatment difference in proportions at Week 48.||0.28|-0.07|
72335941|NCT00098748|144194940|SUPERIORITY_OR_OTHER||difference in proportions|-0.05|||||TWO_SIDED|95.0|-0.21|0.12|||||The TX difference is weighted (by inverse of the variance) difference in proportions adjusted for randomization strata. Positive values for TX difference favor MVC. CI estimated using the normal approximation to the binomial distribution.|MVC QD vs PBO treatment difference in proportions at Week 24.||0.12|-0.21|
72335942|NCT00098748|144194940|SUPERIORITY_OR_OTHER||difference in proportions|0.08|||||TWO_SIDED|95.0|-0.1|0.26|||||The TX difference is weighted (by inverse of the variance) difference in proportions adjusted for randomization strata. Positive values for TX difference favor MVC. CI estimated using the normal approximation to the binomial distribution.|MVC BID vs PBO treatment difference in proportions at Week 24.||0.26|-0.10|
72335943|NCT00098748|144194940|SUPERIORITY_OR_OTHER||difference in proportions|-0.02|||||TWO_SIDED|95.0|-0.18|0.13|||||The TX difference is weighted (by inverse of the variance) difference in proportions adjusted for randomization strata. Positive values for TX difference favor MVC. CI estimated using the normal approximation to the binomial distribution.|MVC QD vs PBO treatment difference in proportions at Week 48.||0.13|-0.18|
72335944|NCT00098748|144194940|SUPERIORITY_OR_OTHER||difference in proportions|0.12|||||TWO_SIDED|95.0|-0.04|0.29|||||The TX difference is weighted (by inverse of the variance) difference in proportions adjusted for randomization strata. Positive values for TX difference favor MVC. CI estimated using the normal approximation to the binomial distribution.|MVC BID vs PBO treatment difference in proportions at Week 48.||0.29|-0.04|
72335945|NCT00098748|144194941|SUPERIORITY_OR_OTHER||difference in proportions|0.07|||||TWO_SIDED|95.0|-0.07|0.2|||||The TX difference is weighted (by inverse of the variance) difference in proportions adjusted for randomization strata. Positive values for TX difference favor MVC. CI estimated using the normal approximation to the binomial distribution.|MVC QD vs PBO treatment difference in proportions at Week 24.||0.20|-0.07|
72335946|NCT00098748|144194941|SUPERIORITY_OR_OTHER||difference in proportions|0.11|||||TWO_SIDED|95.0|-0.03|0.26|||||The TX difference is weighted (by inverse of the variance) difference in proportions adjusted for randomization strata. Positive values for TX difference favor MVC. CI estimated using the normal approximation to the binomial distribution.|MVC BID vs PBO difference in proportions at Week 24.||0.26|-0.03|
72335947|NCT00098748|144194941|SUPERIORITY_OR_OTHER||difference in proportions|-0.04|||||TWO_SIDED|95.0|-0.18|0.1|||||The TX difference is weighted (by inverse of the variance) difference in proportions adjusted for randomization strata. Positive values for TX difference favor MVC. CI estimated using the normal approximation to the binomial distribution.|MVC QD vs PBO treatment difference in proportions at Week 48.||0.10|-0.18|
72426423|NCT01702428|144364808|NON_INFERIORITY|The Lower Limit (LL) of 2-sided 95 % CI for the difference in seroresponse (INV\_MMR Group minus COM\_MMR Group) should be ≥-5% for antibodies to measles virus.|Difference in seroresponse rate|0.18|||||TWO_SIDED|95.0|-0.68|1.25|||||Asymptotic standardized 95% CIs for the difference in seroresponse rate.|Difference in percentage (INV\_MMR Group minus COM\_MMR Group) of subjects with anti-measles antibody concentration at Day 42.||1.25|-0.68|
72335948|NCT00098748|144194941|SUPERIORITY_OR_OTHER||difference in proportions|0.06|||||TWO_SIDED|95.0|-0.1|0.21|||||The TX difference is weighted (by inverse of the variance) difference in proportions adjusted for randomization strata. Positive values for TX difference favor MVC. CI estimated using the normal approximation to the binomial distribution.|MVC BID vs PBO treatment difference in proportions at Week 48.||0.21|-0.10|
72335949|NCT00098748|144194942|SUPERIORITY_OR_OTHER||Least squares mean|23.927|STANDARD_ERROR_OF_MEAN|12.8025|||TWO_SIDED|95.0|-1.359|49.213|||ANCOVA|TX difference adjusted for randomization strata.|Negative values for change from baseline=benefit of TX; negative values for MVC vs PBO=advantage of MVC.|MVC QD vs PBO treatment difference at Week 24.||49.213|-1.359|
72335950|NCT00098748|144194942|SUPERIORITY_OR_OTHER||Least squares mean|26.679|STANDARD_ERROR_OF_MEAN|13.0678|||TWO_SIDED|95.0|0.869|52.49|||ANCOVA|TX difference adjusted for randomization strata.|Negative values for change from baseline=benefit of TX; negative values for MVC vs PBO=advantage of MVC.|MVC BID vs PBO treatment difference at Week 24.||52.490|0.869|
72335951|NCT00098748|144194942|SUPERIORITY_OR_OTHER||Least squares mean|14.61|STANDARD_ERROR_OF_MEAN|16.412|||TWO_SIDED|95.0|-17.8|47.03|||ANCOVA|TX difference adjusted for randomization strata.|Negative values for change from baseline=benefit of TX; negative values for MVC vs PBO=advantage of MVC.|MVC QD vs PBO treatment difference at Week 48.||47.03|-17.80|
72335952|NCT00098748|144194942|SUPERIORITY_OR_OTHER||Least squares mean|27.71|STANDARD_ERROR_OF_MEAN|16.754|||TWO_SIDED|95.0|-5.38|60.8|||ANCOVA|TX difference adjusted for randomization strata.|Negative values for change from baseline=benefit of TX; negative values for MVC vs PBO=advantage of MVC.|MVC BID vs PBO treatment difference at Week 48.||60.80|-5.38|
72335953|NCT00098748|144194943|SUPERIORITY_OR_OTHER||Least squares mean|234.499|STANDARD_ERROR_OF_MEAN|80.799|||TWO_SIDED|95.0|74.913|394.084|||ANCOVA|TX difference adjusted for randomization strata.|Negative values for change from baseline=benefit of TX; negative values for MVC vs PBO=advantage of MVC.|MVC QD vs PBO treatment difference at Week 24.||394.084|74.913|
72335954|NCT00098748|144194943|SUPERIORITY_OR_OTHER||Least squares mean|188.817|STANDARD_ERROR_OF_MEAN|83.4484|||TWO_SIDED|95.0|23.999|353.635|||ANCOVA|TX difference adjusted for randomization strata.|Negative values for change from baseline=benefit of TX; negative values for MVC vs PBO=advantage of MVC.|MVC BID vs PBO treatment difference at Week 24.||353.635|23.999|
72335955|NCT00098748|144194943|SUPERIORITY_OR_OTHER||Least squares mean|155.94|STANDARD_ERROR_OF_MEAN|87.304|||TWO_SIDED|95.0|-16.49|328.37|||ANCOVA|TX difference adjusted for randomization strata.|Negative values for change from baseline=benefit of TX; negative values for MVC vs PBO=advantage of MVC.|MVC QD vs PBO treatment difference at Week 48.||328.37|-16.49|
72335956|NCT00098748|144194943|SUPERIORITY_OR_OTHER||Least squares mean|182.91|STANDARD_ERROR_OF_MEAN|90.174|||TWO_SIDED|95.0|4.81|361.02|||ANCOVA|TX difference adjusted for randomization strata.|Negative values for change from baseline=benefit of TX; negative values for MVC vs PBO=advantage of MVC.|MVC BID vs PBO treatment difference at Week 48.||361.02|4.81|
72335957|NCT00098748|144194944|SUPERIORITY_OR_OTHER|||||||0.7524||95.0|||||Log Rank|||MVC QD vs PBO at Week 24. Kaplan-Meier survival estimates. TX difference evaluated by log-rank test.||||0.7524
72335958|NCT00098748|144194944|SUPERIORITY_OR_OTHER|||||||0.254||95.0|||||Log Rank|||MVC BID vs PBO at Week 24. Kaplan-Meier survival estimates. TX difference evaluated by log-rank test.||||0.2540
72335959|NCT00098748|144194944|SUPERIORITY_OR_OTHER|||||||0.8243||95.0|||||Log Rank|||MVC QD vs PBO at Week 48. Kaplan-Meier survival estimates. TX difference evaluated by log-rank test.||||0.8243
72335960|NCT00098748|144194944|SUPERIORITY_OR_OTHER|||||||0.6657||95.0|||||Log Rank|||MVC BID vs PBO at Week 48. Kaplan-Meier survival estimates. TX difference evaluated by log-rank test.||||0.6657
72335961|NCT00098748|144194945|SUPERIORITY_OR_OTHER||Least squares mean|0.069|STANDARD_ERROR_OF_MEAN|0.2356|||TWO_SIDED|95.0|-0.396|0.535|||ANCOVA|TX difference adjusted for randomization strata.||MVC QD vs PBO treatment difference at Week 24.||0.535|-0.396|
72426424|NCT01702428|144364809|NON_INFERIORITY|The LL of the 2-sided 95% CI on GMC ratio (INV\_MMR Group over COM\_MMR Group) should be ≥0.67 for antibodies to measles virus.|Adjusted GMC ratio|0.98|||||TWO_SIDED|95.0|0.93|1.05|||ANOVA|95% CI for GMC ratio (INV\_MMR over COM\_ MMR) was computed using ANOVA (vaccine groups \& country as fixed effects) on log-transformed concentrations.||Adjusted GMC ratio (INV\_MMR Group divided by COM\_MMR Group) for antibodies to measles virus at Day 42.||1.05|0.93|
72426425|NCT01702428|144364810|NON_INFERIORITY|The LL of 2-sided 95 % CI for the difference in seroresponse (INV\_MMR Group minus COM\_MMR Group) should be ≥-5% for antibodies to mumps virus.|Difference in seroresponse rate|0.81|||||TWO_SIDED|95.0|-0.1|1.96|||||Asymptotic standardized 95% CIs for the difference in seroresponse rate.|Difference in percentage (INV\_MMR Group minus COM\_MMR Group) of subjects with anti-mumps antibody concentration at Day 42.||1.96|-0.1|
72426426|NCT01702428|144364811|NON_INFERIORITY|The LL of the 2-sided 95% CI on GMC ratio (INV\_MMR Group over COM\_MMR Group) should be ≥0.67 for antibodies to mumps virus.|Adjusted GMC ratio|1.05|||||TWO_SIDED|95.0|0.99|1.11|||ANOVA|95% CI for GMC ratio (INV\_MMR over COM\_ MMR) was computed using ANOVA (vaccine groups \& country as fixed effects) on log-transformed concentrations.||Adjusted GMC ratio (INV\_MMR Group divided by COM\_MMR Group) for antibodies to mumps virus at Day 42.||1.11|0.99|
72426427|NCT01702428|144364812|NON_INFERIORITY|The LL of 2-sided 95 % CI for the difference in seroresponse (INV\_MMR Group minus COM\_MMR Group) should be ≥-5% for antibodies to rubella virus.|Difference in seroresponse rate|-1.15|||||TWO_SIDED|95.0|-2.0|-0.15|||||Asymptotic standardized 95% CIs for the difference in seroresponse rate.|Difference in percentage (INV\_MMR Group minus COM\_MMR Group) of subjects with anti-rubella antibody concentration at Day 42.||-0.15|-2.00|
72426428|NCT01702428|144364813|NON_INFERIORITY|The LL of the 2-sided 95% CI on GMC ratio (INV\_MMR Group over COM\_MMR Group) should be ≥0.67 for antibodies to measles virus.|Adjusted GMC ratio|0.87|||||TWO_SIDED|95.0|0.83|0.92|||ANOVA|95% CI for GMC ratio (INV\_MMR over COM\_ MMR) was computed using ANOVA (vaccine groups \& country as fixed effects) on log-transformed concentrations.||Adjusted GMC ratio (INV\_MMR Group divided by COM\_MMR Group) for antibodies to rubella virus at Day 42.||0.92|0.83|
72426429|NCT01702428|144364814|NON_INFERIORITY|The LL of 2-sided 95 % CI for the difference in seroresponse (pooled INV\_MMR Group minus pooled COM\_MMR Group) should be ≥-10% for antibodies to VZV.|Difference in seroresponse rate|1.3|||||TWO_SIDED|95.0|-1.31|4.29|||||Asymptotic standardized 95% CIs for the difference in seroresponse rate.|In US sub-cohort: Difference in percentage (INV\_MMR Group minus COM\_MMR Group) of subjects with anti-VZV antibody concentration at Day 42.||4.29|-1.31|
72426430|NCT01702428|144364815|NON_INFERIORITY|The LL of the 2-sided 95% CI on GMC ratio (INV\_MMR Group over COM\_MMR Group) should be ≥0.67 for antibodies to VZV.|Adjusted GMC ratio|1.01|||||TWO_SIDED|95.0|0.95|1.08|||ANOVA|95% CI for GMC ratio (INV\_MMR over COM\_ MMR) was computed using ANOVA (vaccine groups \& country as fixed effects) on log-transformed concentrations.||In US sub-cohort: Adjusted GMC ratio (INV\_MMR Group divided by COM\_MMR Group) for antibodies to VZV virus at Day 42.||1.08|0.95|
72426431|NCT01702428|144364817|NON_INFERIORITY|The LL of the 2-sided 95% CI on GMC ratio (INV\_MMR Group over COM\_MMR Group) was ≥0.5 for antibodies to HAV virus.|Adjusted GMC ratio|0.98|||||TWO_SIDED|95.0|0.86|1.11|||ANOVA|95% CI for GMC ratio (INV\_MMR over COM\_ MMR) was computed using ANOVA (vaccine groups \& country as fixed effects) on log-transformed concentrations.||In US sub-cohort: Adjusted GMC ratio (INV\_MMR Group divided by COM\_MMR Group) for antibodies to HAV virus at Day 42.||1.11|0.86|
72426432|NCT01702428|144364818|NON_INFERIORITY|The LL of the 2-sided 95% CI for GMC ratio (INV\_MMR Group over COM\_MMR Group) should be ≥0.5 for antibodies to for antibodies to PS serotypes.|Adjusted GMC ratio|0.94|||||TWO_SIDED|95.0|0.85|1.05|||ANCOVA|95% CI for GMC ratio (INV\_MMR Group over the COM\_MMR Group) was computed using an ANCOVA model: Adjustment for baseline concentration-pooled variance.||In US sub-cohort: Adjusted GMC ratio (INV\_MMR Group divided by COM\_MMR Group) for anti-PnPS 1 antibody at Day 42.||1.05|0.85|
72426433|NCT01702428|144364818|NON_INFERIORITY|The LL of the 2-sided 95% CI for GMC ratio (INV\_MMR Group over COM\_MMR Group) should be ≥0.5 for antibodies to for antibodies to PS serotypes.|Adjusted GMC ratio|0.99|||||TWO_SIDED|95.0|0.91|1.08|||ANCOVA|95% CI for GMC ratio (INV\_MMR Group over the COM\_MMR Group) was computed using an ANCOVA model: Adjustment for baseline concentration-pooled variance.||In US sub-cohort: Adjusted GMC ratio (INV\_MMR Group divided by COM\_MMR Group) for anti-PnPS 3 antibody at Day 42.||1.08|0.91|
72426434|NCT01702428|144364818|NON_INFERIORITY|The LL of the 2-sided 95% CI for GMC ratio (INV\_MMR Group over COM\_MMR Group) should be ≥0.5 for antibodies to for antibodies to PS serotypes.|Adjusted GMC ratio|0.88||||||95.0|0.79|0.98|||ANCOVA|95% CI for GMC ratio (INV\_MMR Group over the COM\_MMR Group) was computed using an ANCOVA model: Adjustment for baseline concentration-pooled variance.||In US sub-cohort: Adjusted GMC ratio (INV\_MMR Group divided by COM\_MMR Group) for anti-PnPS 4 antibody at Day 42.||0.98|0.79|
72426435|NCT01702428|144364818|NON_INFERIORITY|The LL of the 2-sided 95% CI for GMC ratio (INV\_MMR Group over COM\_MMR Group) should be ≥0.5 for antibodies to for antibodies to PS serotypes.|Adjusted GMC ratio|0.92|||||TWO_SIDED|95.0|0.83|1.01|||ANCOVA|95% CI for GMC ratio (INV\_MMR Group over the COM\_MMR Group) was computed using an ANCOVA model: Adjustment for baseline concentration-pooled variance.||In US sub-cohort: Adjusted GMC ratio (INV\_MMR Group divided by COM\_MMR Group) for anti-PnPS 5 antibody at Day 42.||1.01|0.83|
72426436|NCT01702428|144364818|NON_INFERIORITY|The LL of the 2-sided 95% CI for GMC ratio (INV\_MMR Group over COM\_MMR Group) should be ≥0.5 for antibodies to for antibodies to PS serotypes.|Adjusted GMC ratio|1.01|||||TWO_SIDED|95.0|0.92|1.11|||ANCOVA|95% CI for GMC ratio (INV\_MMR Group over the COM\_MMR Group) was computed using an ANCOVA model: Adjustment for baseline concentration-pooled variance.||In US sub-cohort: Adjusted GMC ratio (INV\_MMR Group divided by COM\_MMR Group) for anti-PnPS 6A antibody at Day 42.||1.11|0.92|
72426437|NCT01702428|144364818|NON_INFERIORITY|The LL of the 2-sided 95% CI for GMC ratio (INV\_MMR Group over COM\_MMR Group) should be ≥0.5 for antibodies to for antibodies to PS serotypes.|Adjusted GMC ratio|0.98|||||TWO_SIDED|95.0|0.89|1.09|||ANCOVA|95% CI for GMC ratio (INV\_MMR Group over the COM\_MMR Group) was computed using an ANCOVA model: Adjustment for baseline concentration-pooled variance.||In US sub-cohort: Adjusted GMC ratio (INV\_MMR Group divided by COM\_MMR Group) for anti-PnPS 6B antibody at Day 42.||1.09|0.89|
72426438|NCT01702428|144364818|NON_INFERIORITY|The LL of the 2-sided 95% CI for GMC ratio (INV\_MMR Group over COM\_MMR Group) should be ≥0.5 for antibodies to for antibodies to PS serotypes.|Adjusted GMC ratio|0.94|||||TWO_SIDED|95.0|0.86|1.03|||ANCOVA|95% CI for GMC ratio (INV\_MMR Group over the COM\_MMR Group) was computed using an ANCOVA model: Adjustment for baseline concentration-pooled variance.||In US sub-cohort: Adjusted GMC ratio (INV\_MMR Group divided by COM\_MMR Group) for anti-PnPS 7F antibody at Day 42.||1.03|0.86|
72426439|NCT01702428|144364818|NON_INFERIORITY|The LL of the 2-sided 95% CI for GMC ratio (INV\_MMR Group over COM\_MMR Group) should be ≥0.5 for antibodies to for antibodies to PS serotypes.|Adjusted GMC ratio|0.99|||||TWO_SIDED|95.0|0.9|1.08|||ANCOVA|95% CI for GMC ratio (INV\_MMR Group over the COM\_MMR Group) was computed using an ANCOVA model: Adjustment for baseline concentration-pooled variance.||In US sub-cohort: Adjusted GMC ratio (INV\_MMR Group divided by COM\_MMR Group) for anti-PnPS 9V antibody at Day 42.||1.08|0.90|
72426440|NCT01702428|144364818|NON_INFERIORITY|The LL of the 2-sided 95% CI for GMC ratio (INV\_MMR Group over COM\_MMR Group) should be ≥0.5 for antibodies to for antibodies to PS serotypes.|Adjusted GMC ratio|0.91|||||TWO_SIDED|95.0|0.81|1.02|||ANCOVA|95% CI for GMC ratio (INV\_MMR Group over the COM\_MMR Group) was computed using an ANCOVA model: Adjustment for baseline concentration-pooled variance.||In US sub-cohort: Adjusted GMC ratio (INV\_MMR Group divided by COM\_MMR Group) for anti-PnPS 14 antibody at Day 42.||1.02|0.81|
72426441|NCT01702428|144364818|NON_INFERIORITY|The LL of the 2-sided 95% CI for GMC ratio (INV\_MMR Group over COM\_MMR Group) should be ≥0.5 for antibodies to for antibodies to PS serotypes.|Adjusted GMC ratio|0.92|||||TWO_SIDED|95.0|0.84|1.02|||ANCOVA|95% CI for GMC ratio (INV\_MMR Group over the COM\_MMR Group) was computed using an ANCOVA model: Adjustment for baseline concentration-pooled variance.||In US sub-cohort: Adjusted GMC ratio (INV\_MMR Group divided by COM\_MMR Group) for anti-PnPS 18C antibody at Day 42.||1.02|0.84|
72335962|NCT00098748|144194945|SUPERIORITY_OR_OTHER||Least squares mean|-0.218|STANDARD_ERROR_OF_MEAN|0.2413|||TWO_SIDED|95.0|-0.694|0.258|||ANCOVA|TX difference adjusted for randomization strata.||MVC BID vs PBO treatment difference at Week 24.||0.258|-0.694|
72335963|NCT00098748|144194945|SUPERIORITY_OR_OTHER||Least squares mean|0.209|STANDARD_ERROR_OF_MEAN|0.2388|||TWO_SIDED|95.0|-0.262|0.681|||ANCOVA|TX difference adjusted for randomization strata.||MVC QD vs PBO treatment difference at Week 48.||0.681|-0.262|
72335964|NCT00098748|144194945|SUPERIORITY_OR_OTHER||Least squares mean|-0.284|STANDARD_ERROR_OF_MEAN|0.2445|||TWO_SIDED|95.0|-0.767|0.199|||ANCOVA|TX difference adjusted for randomization strata.||MVC BID vs PBO treatment difference at Week 48.||0.199|-0.767|
72335965|NCT02499900|144194959|SUPERIORITY||Mean Difference (Final Values)|0.321|||<|0.001|TWO_SIDED|95.0|0.1615|0.4814||0.05 level of significance|Repeated Measures ANCOVA|||Estimates and p-value are obtained from baseline-adjusted repeated measures ANCOVA model with visit as a repeated effect: MSQ=baseline MSQ score+treatment+visit+treatment by visit interaction. Treatment-naïve patients are not included in this analysis as MSQ is not measured at baseline for these patients.||0.4814|0.1615|<0.001
72335966|NCT02499900|144194960|SUPERIORITY||Mean Difference (Final Values)|9.448|||<|0.001|TWO_SIDED|95.0|6.9538|11.9429||0.05 level of significance|Repeated Measures ANCOVA|||Estimates and p-value are obtained from baseline-adjusted repeated measures ANCOVA model with visit as a repeated effect: TSQM-9 convenience score=baseline TSQM-9 convenience score+treatment+CGR+treatment by visit interaction. Treatment-naïve patients are not included in this analysis as TSQM-9 is not measured at baseline for these patients.||11.9429|6.9538|<0.001
72335967|NCT02499900|144194961|SUPERIORITY||Mean Difference (Final Values)|-0.802||||0.208|TWO_SIDED|95.0|-2.05|0.4461||0.05 level of significance|Repeated Measures ANCOVA|||MFIS Total Score Estimates and p-values are obtained from baseline-adjusted repeated measures ANCOVA model with visit as a repeated effect: change from baseline MFIS score=baseline MFIS score+treatment+visit +CGR+treatment by visit interaction.||0.4461|-2.0500|0.208
72335968|NCT02499900|144194961|SUPERIORITY||Mean Difference (Final Values)|-0.231||||0.47|TWO_SIDED|95.0|-0.8588|0.3962||0.05 level of significance|Repeated Measures ANCOVA|||MFIS Physical Subscale Estimates and p-values are obtained from baseline-adjusted repeated measures ANCOVA model with visit as a repeated effect: change from baseline MFIS score=baseline MFIS score+treatment+visit +CGR+treatment by visit interaction.||0.3962|-0.8588|0.470
72335969|NCT02499900|144194961|SUPERIORITY||Mean Difference (Final Values)|-0.639||||0.043|TWO_SIDED|95.0|-1.2564|-0.0214||0.05 level of significance|Repeated Measures ANCOVA|||MFIS Cognitive Subscale Estimates and p-values are obtained from baseline-adjusted repeated measures ANCOVA model with visit as a repeated effect: change from baseline MFIS score=baseline MFIS score+treatment+visit +CGR+treatment by visit interaction.||-0.0214|-1.2564|0.043
72335970|NCT02499900|144194961|SUPERIORITY||Mean Difference (Final Values)|0.102||||0.237|TWO_SIDED|95.0|-0.0672|0.2711||0.05 level of significance|Repeated Measures ANCOVA|||MFIS Psychosocial Subscale Estimates and p-values are obtained from baseline-adjusted repeated measures ANCOVA model with visit as a repeated effect: change from baseline MFIS score=baseline MFIS score+treatment+visit +CGR+treatment by visit interaction.||0.2711|-0.0672|0.237
72335971|NCT02499900|144194962|SUPERIORITY||Mean Difference (Final Values)|0.706||||0.287|TWO_SIDED|95.0|-0.5947|1.0074||0.05 level of significance|Repeated Measures ANCOVA|||Total Score Estimates and p-values are obtained from baseline-adjusted repeated measures ANCOVA model with visit as a repeated effect: change from baseline MHI score=baseline MHI Total Score +treatment +visit +country/geographic region +treatment by visit interaction.||1.0074|-0.5947|0.287
72335972|NCT02499900|144194962|SUPERIORITY||Mean Difference (Final Values)|0.141||||0.868|TWO_SIDED|95.0|-1.5179|1.7991||0.05 level of significance|Repeated Measures ANCOVA|||Anxiety subscale Estimates and p-values are obtained from baseline-adjusted repeated measures ANCOVA model with visit as a repeated effect: change from baseline MHI score=baseline MHI Total Score +treatment +visit +country/geographic region +treatment by visit interaction.||1.7991|-1.5179|0.868
72335973|NCT02499900|144194962|SUPERIORITY||Mean Difference (Final Values)|0.481||||0.544|TWO_SIDED|95.0|-1.0734|2.0348||0.05 level of significance|Repeated Measures ANCOVA|||Depression subscale estimates and p-values are obtained from baseline-adjusted repeated measures ANCOVA model with visit as a repeated effect: change from baseline MHI score=baseline MHI Total Score +treatment +visit +country/geographic region +treatment by visit interaction.||2.0348|-1.0734|0.544
72335974|NCT02499900|144194962|SUPERIORITY||Mean Difference (Final Values)|1.867||||0.014|TWO_SIDED|95.0|0.3843|3.3487||0.05 level of significance|Repeated Measures ANCOVA|||Behavioral Control subscale Estimates and p-values are obtained from baseline-adjusted repeated measures ANCOVA model with visit as a repeated effect: change from baseline MHI score=baseline MHI Total Score +treatment +visit +country/geographic region +treatment by visit interaction.||3.3487|0.3843|0.014
72335975|NCT02499900|144194962|SUPERIORITY||Mean Difference (Final Values)|-0.092||||0.919|TWO_SIDED|95.0|-1.8565|1.6728||0.05 level of significance|Repeated Measures ANCOVA|||MHI Positive Affect subscale Estimates and p-values are obtained from baseline-adjusted repeated measures ANCOVA model with visit as a repeated effect: change from baseline MHI score=baseline MHI Total Score +treatment +visit +country/geographic region +treatment by visit interaction.||1.6728|-1.8565|0.919
72335976|NCT02499900|144194963|SUPERIORITY||Mean Difference (Final Values)|-0.059||||0.851|TWO_SIDED|95.0|-0.6777|0.5592||0.05 level of significance|Repeated Measures ANCOVA|||Estimates and p-values are obtained from baseline-adjusted repeated measures ANCOVA model with visit as a repeated effect: change from baseline BDI-II total score=baseline BDI-II total score+treatment+visit+country/geographic region +treatment by visit interaction.||0.5592|-0.6777|0.851
72426442|NCT01702428|144364818|NON_INFERIORITY|The LL of the 2-sided 95% CI for GMC ratio (INV\_MMR Group over COM\_MMR Group) should be ≥0.5 for antibodies to for antibodies to PS serotypes.|Adjusted GMC ratio|0.97|||||TWO_SIDED|95.0|0.87|1.07|||ANCOVA|95% CI for GMC ratio (INV\_MMR Group over the COM\_MMR Group) was computed using an ANCOVA model: Adjustment for baseline concentration-pooled variance.||In US sub-cohort: Adjusted GMC ratio (INV\_MMR Group divided by COM\_MMR Group) for anti-PnPS 19A antibody at Day 42.||1.07|0.87|
72426443|NCT01702428|144364818|NON_INFERIORITY|The LL of the 2-sided 95% CI for GMC ratio (INV\_MMR Group over COM\_MMR Group) should be ≥0.5 for antibodies to for antibodies to PS serotypes.|Adjusted GMC ratio|0.96|||||TWO_SIDED|95.0|0.87|1.06|||ANCOVA|95% CI for GMC ratio (INV\_MMR Group over the COM\_MMR Group) was computed using an ANCOVA model: Adjustment for baseline concentration-pooled variance.||In US sub-cohort: Adjusted GMC ratio (INV\_MMR Group divided by COM\_MMR Group) for anti-PnPS 19F antibody at Day 42.||1.06|0.87|
72426444|NCT01702428|144364818|NON_INFERIORITY|The LL of the 2-sided 95% CI for GMC ratio (INV\_MMR Group over COM\_MMR Group) should be ≥0.5 for antibodies to for antibodies to PS serotypes.|Adjusted GMC ratio|0.95|||||TWO_SIDED|95.0|0.85|1.06|||ANCOVA|95% CI for GMC ratio (INV\_MMR Group over the COM\_MMR Group) was computed using an ANCOVA model: Adjustment for baseline concentration-pooled variance.||In US sub-cohort: Adjusted GMC ratio (INV\_MMR Group divided by COM\_MMR Group) for anti-PnPS 23F antibody at Day 42.||1.06|0.85|
72335977|NCT03998670|144194972|SUPERIORITY||Mean Difference (Final Values)|0.3|||||TWO_SIDED|95.0|-0.5|1.1|||||Difference in mean control and 95% confidence interval (CI) are from ANCOVA model adjusting for corresponding baseline control score. Prism group minus Non-Prism group (positive difference indicates Prism group worse than Non-Prism group).|The primary analysis was the treatment group difference (and 95% CI) in mean distance control at the 8-week outcome visit using an ANCOVA adjusted for baseline distance control. The planned convenience sample size of 64 was expected to provide outcome data for at least 60 participants (30 per group).||1.1|-0.5|
72335978|NCT03998670|144194973|SUPERIORITY||Mean Difference (Final Values)|8.0|||||TWO_SIDED|95.0|-17.0|32.0|||||Difference between Prism minus Non-Prism group (positive difference indicates Prism group better than Non-Prism group).|||32|-17|
72335979|NCT03998670|144194974|SUPERIORITY||Mean Difference (Final Values)|-4.0|||||TWO_SIDED|95.0|-27.0|19.0|||||Difference between Prism minus Non-Prism group (positive difference indicates Prism group better than Non-Prism group).|||19|-27|
72335980|NCT03998670|144194976|SUPERIORITY||Mean Difference (Final Values)|0.01|||||TWO_SIDED|95.0|-0.7|0.7|||||Difference in mean control and 95% confidence interval (CI) are from ANCOVA model adjusting for corresponding baseline control score. Prism group minus Non-Prism group (positive difference indicates Prism group worse than Non-Prism group).|The secondary analysis was the treatment group difference (and 95% CI) in mean near control at the 8-week outcome visit using an ANCOVA adjusted for baseline near control.||0.7|-0.7|
72335981|NCT01081301|144195013|SUPERIORITY_OR_OTHER||||||<|0.05||95.0||||The p-value were not adjusted for multiple comparisons and a p-value of 0.05 was used for statistical significance.|ANOVA|Modified version of ANOVA as it overcomes the shortcoming of the ANOVA model by taking into account unbalanced data and repeated measures.||Generalized estimating equations were used to determine change in patterns of the Herth Hope Index over time (Day 7, 14 and 3, 6, and 12 months) compared to baseline. The advantage of utilizing general estimating equations was that it effectively increases the sample size (increasing power) and estimated more robust standard errors by taking into account the repeated measures and adjusting for covariates.||||<0.05
72335982|NCT01081301|144195014|SUPERIORITY_OR_OTHER||||||<|0.05||95.0||||The p-value were not adjusted for multiple comparisons and a p-value of 0.05 was used for statistical significance.|ANOVA|Modified version of ANOVA as it overcomes the shortcoming of the ANOVA model by taking into account unbalanced data and repeated measures.||Generalized estimating equations were used to determine change in patterns of SF-12v2 Mental health scores over time (Day 7, 14 and 3, 6, and 12 months) compared to baseline. The advantage of utilizing general estimating equations was that it effectively increases the sample size (increasing power) and estimated more robust standard errors by taking into account the repeated measures and adjusting for covariates.||||<0.05
72335983|NCT01081301|144195015|SUPERIORITY_OR_OTHER||||||<|0.05||95.0||||The p-value were not adjusted for multiple comparisons and a p-value of 0.05 was used for statistical significance.|ANOVA|Modified version of ANOVA as it overcomes the shortcoming of the ANOVA model by taking into account unbalanced data and repeated measures||Generalized estimating equations were used to determine change in patterns of General Self Efficacy Scale scores over time (Day 7, 14 and 3, 6, and 12 months) compared to baseline. The advantage of utilizing general estimating equations was that it effectively increases the sample size (increasing power) and estimated more robust standard errors by taking into account the repeated measures and adjusting for covariates.||||<0.05
72335984|NCT01081301|144195016|SUPERIORITY_OR_OTHER||||||>|0.05||95.0||||The p-value were not adjusted for multiple comparisons and a p-value of 0.05 was used for statistical significance.|ANOVA|Modified version of ANOVA as it overcomes the shortcoming of the ANOVA model by taking into account unbalanced data and repeated measures.||Generalized estimating equations were used to determine change in patterns of Non Death Revised Grief Experience Inventory scores over time (Day 7, 14 and 3, 6, and 12 months) compared to baseline. The advantage of utilizing general estimating equations was that it effectively increases the sample size (increasing power) and estimated more robust standard errors by taking into account the repeated measures and adjusting for covariates.||||>0.05
72335985|NCT01081301|144195017|SUPERIORITY_OR_OTHER||||||<|0.05||95.0||||The p-value were not adjusted for multiple comparisons and a p-value of 0.05 was used for statistical significance.|ANOVA|Modified version of ANOVA as it overcomes the shortcoming of the ANOVA model by taking into account unbalanced data and repeated measures.||Generalized estimating equations were used to determine change in patterns of SF-12v2 Physical health scores over time (Day 7, 14 and 3, 6, and 12 months) compared to baseline. The advantage of utilizing general estimating equations was that it effectively increases the sample size (increasing power) and estimated more robust standard errors by taking into account the repeated measures and adjusting for covariates.||||<0.05
72335986|NCT03551665|144195037|OTHER||Mean Difference (Final Values)|0.029||||0.036|TWO_SIDED|95.0|0.002|0.056|||Regression, Linear|||These data are the immediate improvements (base 2 - post 1) in the MS group.||0.056|.002|0.036
72426445|NCT05462652|144364883|SUPERIORITY||Mean Difference (Final Values)|-2.63|STANDARD_ERROR_OF_MEAN|0.53|<|0.001|TWO_SIDED|95.0|-3.68|-1.59|||Mixed Models Analysis|||||-1.59|-3.68|<0.001
72426446|NCT05462652|144364884|SUPERIORITY||Difference in proportion z-test|20.1|||<|0.001|TWO_SIDED|95.0|9.1|31.0|||Chi-squared|||"Missing values imputed with multiple imputation.~P-values are obtained from a Pearson Chi-Squared test; differences and 95% CIs are obtained from a difference in proportions Z- test."||31.0|9.1|<0.001
72426447|NCT05462652|144364885|SUPERIORITY||Difference in proportions z-test|15.4||||0.003|TWO_SIDED|95.0|5.3|25.6|||Chi-squared|||P-values are obtained from a Pearson Chi-Squared test; differences and 95% CIs are obtained from a difference in proportions Z- test.||25.6|5.3|0.003
72426448|NCT05462652|144364886|SUPERIORITY||Difference in proportion z-test|24.7|||<|0.001|TWO_SIDED|95.0|13.0|36.4|||Chi-squared|||Missing values imputed with multiple imputation. P-values are obtained from a Pearson Chi-Squared test; differences and 95% CIs are obtained from a difference in proportions Z- test.||36.4|13.0|<0.001
72426449|NCT04548531|144364891|SUPERIORITY||Mean Difference (Final Values)|0.67|||<|0.001|TWO_SIDED|95.0|0.41|0.94|||t-test, 2 sided|||||0.94|0.41|<.001
72426450|NCT04548531|144364892|SUPERIORITY||Risk Difference (RD)|21.0||||0.003|TWO_SIDED|95.0|7.0|35.0|||Chi-squared|||||35|7|0.003
72426451|NCT04548531|144364893|SUPERIORITY||Risk Difference (RD)|3.0||||0.75|TWO_SIDED|95.0|-10.0|16.0|||Chi-squared|||We tested for a clear preference for screening, if a patient chose a colonoscopy or a stool-based test vs. the other response options.||16|-10|.75
72426452|NCT04548531|144364894|SUPERIORITY||Risk Difference (RD)|11.0||||0.14|TWO_SIDED|95.0|-3.0|26.0|||Chi-squared|||We categorized for likelihood to follow through with screening. We reported on results from patients who indicated 'Very Likely' on their response option vs. the other options (likely, unsure, unlikely, very unlikely)||26|-3|0.14
72426453|NCT04548531|144364895|SUPERIORITY||Risk Difference (RD)|13.0|||<|0.001|TWO_SIDED|95.0|6.0|18.0|||Chi-squared|||Assessed how many patients completed any colorectal cancer screening test within 6-months after randomization.||18|6|<.001
72426454|NCT01613027|144364908|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Paired t-test|||Difference in change at Month 6||||<0.001
72426455|NCT01613027|144364908|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Paired t-test|||Difference in change at Month 12||||<0.001
72426456|NCT02340520|144364954|OTHER||||||>|0.05|||||||t-test, 2 sided|||||||>0.05
72426457|NCT02340520|144364955|OTHER||||||>|0.1|||||||ANOVA|||||||>0.1
72426458|NCT01586338|144365001|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Threshold for significance = 0.05.|Paired t-test|||||||<0.0001
72426459|NCT01586338|144365001|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Sign Rank Test|||||||<0.0001
72426460|NCT01076088|144365053|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-0.27||||0.087|TWO_SIDED|95.0|-0.58|0.04||Pairwise comparison, sitagliptin 50 mg + metformin 850 mg vs. metformin 850 mg. The normality assumption required for validity of ANCOVA was violated due to a biologically implausible extreme outlier. See below for results using robust regression.|ANCOVA|The ANCOVA model included terms for treatment and prior antihyperglycemic agent (AHA) therapy status (yes/no) and a covariate for baseline A1C.||||0.04|-0.58|0.087
72426461|NCT01076088|144365053|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-0.84|||<|0.001|TWO_SIDED|95.0|-1.15|-0.52||Pairwise comparison, sitagliptin 50 mg + metformin 850 mg vs. sitagliptin 100 mg. The normality assumption required for validity of ANCOVA was violated due to a biologically implausible extreme outlier. See below for results using robust regression.|ANCOVA|The ANCOVA model included terms for treatment and prior AHA therapy status (yes/no) and a covariate for baseline A1C.||||-0.52|-1.15|<0.001
72426462|NCT01076088|144365053|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-0.39||||0.014|TWO_SIDED|95.0|-0.69|-0.08||Pairwise comparison, sitagliptin 50 mg + metformin 500 mg vs. metformin 500 mg. The normality assumption required for validity of ANCOVA was violated due to a biologically implausible extreme outlier. See below for results using robust regression.|ANCOVA|The ANCOVA model included terms for treatment and prior AHA therapy status (yes/no) and a covariate for baseline A1C.||||-0.08|-0.69|0.014
72426463|NCT01076088|144365053|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-0.68|||<|0.001|TWO_SIDED|95.0|-0.99|-0.37||Pairwise comparison, sitagliptin 50 mg + metformin 500 mg vs. sitagliptin 100 mg. The normality assumption required for validity of ANCOVA was violated due to a biologically implausible extreme outlier. See below for results using robust regression.|ANCOVA|The ANCOVA model included terms for treatment and prior AHA therapy status (yes/no) and a covariate for baseline A1C.||||-0.37|-0.99|<0.001
72426464|NCT01076088|144365053|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-1.24|||<|0.001|TWO_SIDED|95.0|-1.55|-0.93||Pairwise comparison, sitagliptin 50 mg + metformin 850 mg vs. placebo. The normality assumption required for validity of ANCOVA was violated due to a biologically implausible extreme outlier. See below for results using robust regression.|ANCOVA|The ANCOVA model included terms for treatment and prior AHA therapy status (yes/no) and a covariate for baseline A1C.||||-0.93|-1.55|<0.001
72426465|NCT01076088|144365053|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-0.97|||<|0.001|TWO_SIDED|95.0|-1.28|-0.66||Pairwise comparison, metformin 850 mg vs. placebo. The normality assumption required for validity of ANCOVA was violated due to a biologically implausible extreme outlier. See below for results using robust regression.|ANCOVA|The ANCOVA model included terms for treatment and prior AHA therapy status (yes/no) and a covariate for baseline A1C.||||-0.66|-1.28|<0.001
72426466|NCT01076088|144365053|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-1.08|||<|0.001|TWO_SIDED|95.0|-1.39|-0.78||Pairwise comparison, sitagliptin 50 mg + metformin 500 mg vs. placebo. The normality assumption required for validity of ANCOVA was violated due to a biologically implausible extreme outlier. See below for results using robust regression.|ANCOVA|The ANCOVA model included terms for treatment and prior AHA therapy status (yes/no) and a covariate for baseline A1C.||||-0.78|-1.39|<0.001
72426467|NCT01076088|144365053|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-0.7|||<|0.001|TWO_SIDED|95.0|-1.01|-0.39||Pairwise comparison, metformin 500 mg vs. placebo. The normality assumption required for validity of ANCOVA was violated due to a biologically implausible extreme outlier. See below for results using robust regression.|ANCOVA|The ANCOVA model included terms for treatment and prior AHA therapy status (yes/no) and a covariate for baseline A1C.||||-0.39|-1.01|<0.001
72426468|NCT01076088|144365053|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-0.4||||0.011|TWO_SIDED|95.0|-0.71|-0.09||Pairwise comparison, sitagliptin 100 mg vs. placebo. The normality assumption required for validity of ANCOVA was violated due to a biologically implausible extreme outlier. See below for results using robust regression.|ANCOVA|The ANCOVA model included terms for treatment and prior AHA therapy status (yes/no) and a covariate for baseline A1C.||||-0.09|-0.71|0.011
72426469|NCT01076088|144365053|SUPERIORITY_OR_OTHER||Difference in least squares mean|-0.36||||0.008|TWO_SIDED|95.0|-0.62|-0.09||Pairwise comparison, sitagliptin 50 mg + metformin 850 mg vs. metformin 850 mg. This is a post-hoc analysis using robust regression, a valid method in the presence of outliers.|Regression, Robust|The Robust Regression model included terms for treatment and prior AHA therapy status (yes/no) and a covariate for baseline A1C.||||-0.09|-0.62|0.008
72426470|NCT01076088|144365053|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-0.87|||<|0.001|TWO_SIDED|95.0|-1.13|-0.6||Comparing co-administration with individual components. This is a post-hoc analysis using robust regression, a valid method in the presence of outliers.|Regression, Robust|The Robust Regression model included terms for treatment and prior AHA therapy status (yes/no) and a covariate for baseline A1C.||||-0.60|-1.13|<0.001
72426471|NCT01076088|144365053|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-0.36||||0.007|TWO_SIDED|95.0|-0.63|-0.1||Comparing co-administration with individual components. This is a post-hoc analysis using robust regression, a valid method in the presence of outliers.|Regression, Robust|The Robust Regression model included terms for treatment and prior AHA therapy status (yes/no) and a covariate for baseline A1C.||||-0.10|-0.63|0.007
72426472|NCT01076088|144365053|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-0.61|||<|0.001|TWO_SIDED|95.0|-0.88|-0.35||Comparing co-administration with individual components. This is a post-hoc analysis using robust regression, a valid method in the presence of outliers.|Regression, Robust|The Robust Regression model included terms for treatment and prior AHA therapy status (yes/no) and a covariate for baseline A1C.||||-0.35|-0.88|<0.001
72426473|NCT01076088|144365053|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-1.25|||<|0.001|TWO_SIDED|95.0|-1.52|-0.99||Comparing co-administration with individual components. This is a post-hoc analysis using robust regression, a valid method in the presence of outliers.|Regression, Robust|The Robust Regression model included terms for treatment and prior AHA therapy status (yes/no) and a covariate for baseline A1C.||||-0.99|-1.52|<0.001
72426474|NCT01076088|144365053|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-0.9|||<|0.001|TWO_SIDED|95.0|-1.16|-0.63||Comparing co-administration with individual components. This is a post-hoc analysis using robust regression, a valid method in the presence of outliers.|Regression, Robust|The Robust Regression model included terms for treatment and prior AHA therapy status (yes/no) and a covariate for baseline A1C.||||-0.63|-1.16|<0.001
72426475|NCT01076088|144365053|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-1.0|||<|0.001|TWO_SIDED|95.0|-1.26|-0.74||Comparing co-administration with individual components. This is a post-hoc analysis using robust regression, a valid method in the presence of outliers.|Regression, Robust|The Robust Regression model included terms for treatment and prior AHA therapy status (yes/no) and a covariate for baseline A1C.||||-0.74|-1.26|<0.001
72426476|NCT01076088|144365053|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-0.64|||<|0.001|TWO_SIDED|95.0|-0.9|-0.37||Comparing co-administration with individual components. This is a post-hoc analysis using robust regression, a valid method in the presence of outliers.|Regression, Robust|The Robust Regression model included terms for treatment and prior AHA therapy status (yes/no) and a covariate for baseline A1C.||||-0.37|-0.90|<0.001
72426477|NCT01076088|144365053|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-0.39||||0.004|TWO_SIDED|95.0|-0.65|-0.12||Comparing co-administration with individual components. This is a post-hoc analysis using robust regression, a valid method in the presence of outliers.|Regression, Robust|The Robust Regression model included terms for treatment and prior AHA therapy status (yes/no) and a covariate for baseline A1C.||||-0.12|-0.65|0.004
72426478|NCT01076088|144365054|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-18.52||||0.017|TWO_SIDED|95.0|-33.75|-3.29||Pairwise comparison, sitagliptin 50 mg + metformin 850 mg vs. metformin 850 mg.|ANCOVA|The ANCOVA model included terms for treatment and prior antihyperglycemic agent (AHA) therapy status (yes/no) and a covariate for baseline 2-H PMG.||||-3.29|-33.75|0.017
72426479|NCT01076088|144365054|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-61.34|||<|0.001|TWO_SIDED|95.0|-76.61|-46.07||Pairwise comparison, sitagliptin 50 mg + metformin 850 mg vs. sitagliptin 100 mg|ANCOVA|The ANCOVA model included terms for treatment and prior antihyperglycemic agent (AHA) therapy status (yes/no) and a covariate for baseline 2-H PMG.||||-46.07|-76.61|<0.001
72426480|NCT01076088|144365054|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-31.38|||<|0.001|TWO_SIDED|95.0|-46.49|-16.28||Pairwise comparison, sitagliptin 50 mg + metformin 500 mg vs. metformin 500 mg|ANCOVA|The ANCOVA model included terms for treatment and prior antihyperglycemic agent (AHA) therapy status (yes/no) and a covariate for baseline 2-H PMG.||||-16.28|-46.49|<0.001
72426481|NCT01076088|144365054|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-48.94|||<|0.001|TWO_SIDED|95.0|-64.21|-33.67||Pairwise comparison, sitagliptin 50 mg + metformin 500 mg vs. sitagliptin 100 mg|ANCOVA|The ANCOVA model included terms for treatment and prior antihyperglycemic agent (AHA) therapy status (yes/no) and a covariate for baseline 2-H PMG.||||-33.67|-64.21|<0.001
72335987|NCT03551665|144195038|OTHER||Spearman's Rho|0.019||||0.92|||||||Spearman Correlation|||We correlated cognition (SDMT; above) to the improvement in performance (margin of stability) to to determine whether cognition predicted improvement in stepping outcomes.||||.92
72426482|NCT01076088|144365054|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-87.57|||<|0.001|TWO_SIDED|95.0|-102.87|-72.27||Pairwise comparison, sitagliptin 50 mg + metformin 850 mg vs. placebo|ANCOVA|The ANCOVA model included terms for treatment and prior antihyperglycemic agent (AHA) therapy status (yes/no) and a covariate for baseline 2-H PMG.||||-72.27|-102.87|<0.001
72426483|NCT01076088|144365054|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-69.05|||<|0.001|TWO_SIDED|95.0|-84.41|-53.7||Pairwise comparison, metformin 850 mg vs. placebo|ANCOVA|The ANCOVA model included terms for treatment and prior antihyperglycemic agent (AHA) therapy status (yes/no) and a covariate for baseline 2-H PMG.||||-53.70|-84.41|<0.001
72426484|NCT01076088|144365054|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-75.17|||<|0.001|TWO_SIDED|95.0|-90.47|-59.87||Pairwise comparison, sitagliptin 50 mg + metformin 500 mg vs. placebo|ANCOVA|The ANCOVA model included terms for treatment and prior antihyperglycemic agent (AHA) therapy status (yes/no) and a covariate for baseline 2-H PMG.||||-59.87|-90.47|<0.001
72426485|NCT01076088|144365054|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-43.79|||<|0.001|TWO_SIDED|95.0|-58.99|-28.58||Pairwise comparison, metformin 500 mg vs. placebo|ANCOVA|The ANCOVA model included terms for treatment and prior antihyperglycemic agent (AHA) therapy status (yes/no) and a covariate for baseline 2-H PMG.||||-28.58|-58.99|<0.001
72426486|NCT01076088|144365054|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-26.23|||<|0.001|TWO_SIDED|95.0|-41.62|-10.84||Pairwise comparison, sitagliptin 100 mg vs. placebo|ANCOVA|The ANCOVA model included terms for treatment and prior antihyperglycemic agent (AHA) therapy status (yes/no) and a covariate for baseline 2-H PMG.||||-10.84|-41.62|<0.001
72335988|NCT03551665|144195039|OTHER||Mean Difference (Final Values)|0.026||||0.119||95.0|-0.007|0.059|||Regression, Linear|||We assessed the change in reactive step length before (Baseline 2) to immediately after (post 1) training in the MS group||0.059|-0.007|0.119
72335989|NCT03551665|144195040|OTHER||Mean Difference (Final Values)|-0.041||||0.012||95.0|-0.073|-0.009|||Regression, Linear|||We assessed the change in reactive step latency before (Baseline 2) to immediately after (post 1) training in the MS group||-0.009|-0.073|0.012
72426487|NCT01076088|144365055|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-8.11||||0.069|TWO_SIDED|95.0|-16.86|0.64||Pairwise comparison, sitagliptin 50 mg + metformin 850 mg vs. metformin 850 mg|ANCOVA|The ANCOVA model included terms for treatment and prior antihyperglycemic agent (AHA) therapy status (yes/no) and a covariate for baseline FPG.||||0.64|-16.86|0.069
72426488|NCT01076088|144365055|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-25.88|||<|0.001|TWO_SIDED|95.0|-34.72|-17.04||Pairwise comparison, sitagliptin 50 mg + metformin 850 mg vs. sitagliptin 100 mg|ANCOVA|The ANCOVA model included terms for treatment and prior antihyperglycemic agent (AHA) therapy status (yes/no) and a covariate for baseline FPG.||||-17.04|-34.72|<0.001
72426489|NCT01076088|144365055|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-5.72||||0.198|TWO_SIDED|95.0|-14.44|3.0||Pairwise comparison, sitagliptin 50 mg + metformin 500 mg vs. metformin 500 mg|ANCOVA|The ANCOVA model included terms for treatment and prior antihyperglycemic agent (AHA) therapy status (yes/no) and a covariate for baseline FPG.||||3.00|-14.44|0.198
72426490|NCT01076088|144365055|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-17.53|||<|0.001|TWO_SIDED|95.0|-26.33|-8.72||Pairwise comparison, sitagliptin 50 mg + metformin 500 mg vs. sitagliptin 100 mg|ANCOVA|The ANCOVA model included terms for treatment and prior antihyperglycemic agent (AHA) therapy status (yes/no) and a covariate for baseline FPG.||||-8.72|-26.33|<0.001
72426491|NCT01076088|144365055|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-35.81|||<|0.001|TWO_SIDED|95.0|-44.56|-27.06||Pairwise comparison, sitagliptin 50 mg + metformin 850 mg vs. placebo.|ANCOVA|The ANCOVA model included terms for treatment and prior antihyperglycemic agent (AHA) therapy status (yes/no) and a covariate for baseline FPG.||||-27.06|-44.56|<0.001
72426492|NCT01076088|144365055|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-27.7|||<|0.001|TWO_SIDED|95.0|-36.4|-19.0||Pairwise comparison, metformin 850 mg vs. placebo.|ANCOVA|The ANCOVA model included terms for treatment and prior antihyperglycemic agent (AHA) therapy status (yes/no) and a covariate for baseline FPG.||||-19.00|-36.40|<0.001
72426493|NCT01076088|144365055|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-27.45|||<|0.001|TWO_SIDED|95.0|-36.18|-18.73||Pairwise comparison, sitagliptin 50 mg + metformin 500 mg vs. placebo.|ANCOVA|The ANCOVA model included terms for treatment and prior antihyperglycemic agent (AHA) therapy status (yes/no) and a covariate for baseline FPG.||||-18.73|-36.18|<0.001
72426494|NCT01076088|144365055|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-21.73|||<|0.001|TWO_SIDED|95.0|-30.42|-13.04||Pairwise comparison, metformin 500 mg vs. placebo.|ANCOVA|The ANCOVA model included terms for treatment and prior antihyperglycemic agent (AHA) therapy status (yes/no) and a covariate for baseline FPG.||||-13.04|-30.42|<0.001
72426495|NCT01076088|144365055|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-9.93||||0.027|TWO_SIDED|95.0|-18.72|-1.14||Pairwise comparison, sitagliptin 100 mg vs. placebo.|ANCOVA|The ANCOVA model included terms for treatment and prior antihyperglycemic agent (AHA) therapy status (yes/no) and a covariate for baseline FPG.||||-1.14|-18.72|0.027
72426496|NCT01544491|144365067|NON_INFERIORITY|Kaplan-Meier estimates and between treatment differences are estimated using the Kaplan-Meier product-limit formula and 80% confidence intervals derived using standard errors estimated from Greenwood's formula.|Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|5.25||0.9712|TWO_SIDED|80.0|-6.6|6.8|||Log Rank|||at 12 months||6.8|-6.6|0.9712
72426497|NCT01544491|144365067|NON_INFERIORITY|Kaplan-Meier estimates and between treatment differences are estimated using the Kaplan-Meier product-limit formula and 80% confidence intervals derived using standard errors estimated from Greenwood's formula.|Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|5.84||0.9634|TWO_SIDED|80.0|-7.3|7.7|||Log Rank|||36 months||7.7|-7.3|0.9634
72426498|NCT01544491|144365068|NON_INFERIORITY|KM estimates and between treatment differences are estimated using the Kaplan-Meier product-limit formula and 80% confidence intervals derived using standard errors estimated from Greenwood's formula.|Mean Difference (Net)|5.0|STANDARD_ERROR_OF_MEAN|5.26||0.3455|TWO_SIDED|80.0|-1.8|11.8|||t-test, 2 sided|||at 12 months||11.8|-1.8|0.3455
72426499|NCT01544491|144365068|NON_INFERIORITY|KM estimates and between treatment differences are estimated using the Kaplan-Meier product-limit formula and 80% confidence intervals derived using standard errors estimated from Greenwood's formula.|Mean Difference (Final Values)|0.8|STANDARD_ERROR_OF_MEAN|4.95||0.8642|TWO_SIDED|80.0|-5.5|7.2|||t-test, 2 sided|||36 months||7.2|-5.5|0.8642
72426500|NCT00680056|144365113|SUPERIORITY_OR_OTHER||Mean Difference (Net)|56.0|STANDARD_DEVIATION|60.0||0.038||95.0|||||t-test, 2 sided||Mean difference= Formoterol plus Tiotropium minus Formoterol plus Placebo(Tiotropium)|It was calculated a total sample size of a 2x2 cross-over design as 24 for a two-sided t-test achieves 85% power to infer that the mean difference is not zero, the actual mean difference is 20, the standard deviation of the differences is 15, and the significance level is 0.05||||0.038
72426501|NCT00680056|144365114|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.88|STANDARD_DEVIATION|2.39||0.054||95.0|||||t-test, 2 sided||Mean difference=Arm 2 minus Arm 1|||||0.054
72426502|NCT02733042|144365115|OTHER|||||||||||||||||The safety review committee identified a preliminary recommended Phase 2 dose (RP2D) for each dose finding cohort based on an integrated assessment of the safety, pharmacokinetic, pharmacodynamic, and preliminary efficacy (as available).|For Arm B, ibrutinib 420 mg was confirmed as the RP2D for CLL/SLL participants and ibrutinib 560 mg was confirmed as the RP2D for MCL participants.|||
72426503|NCT02733042|144365115|OTHER|||||||||||||||||The safety review committee identified a preliminary recommended Phase 2 dose (RP2D) for each dose finding cohort based on an integrated assessment of the safety, pharmacokinetic, pharmacodynamic, and preliminary efficacy (as available).|For Arm C the RP2D was confirmed as rituximab 375 mg/m² + bendamustine 70 mg/m².|||
72426504|NCT00337662|144365142|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Between-group p-values for each baseline to post-baseline visit were the same, p\<0.001.|Mixed Effects Model Repeated Measures|||||||<0.001
72426505|NCT00337662|144365143|SUPERIORITY_OR_OTHER|||||||0.266||95.0||||Change from Week 2 to Week 3 p-value|Mixed-Effects Model Repeated-Measures|||||||0.266
72426506|NCT00337662|144365143|SUPERIORITY_OR_OTHER|||||||0.884||95.0||||Change from Week 2 to Week 4 p-value|Mixed-Effects Model Repeated-Measures|||||||0.884
72426507|NCT00337662|144365143|SUPERIORITY_OR_OTHER|||||||0.151||95.0||||Change from Week 2 to Week 6 p-value|Mixed-Effects Model Repeated-Measures|||||||0.151
72426508|NCT00337662|144365143|SUPERIORITY_OR_OTHER|||||||0.216||95.0||||Change from Week 2 to Week 8 p-value|Mixed-Effects Model Repeated-Measures|||||||0.216
72426509|NCT00337662|144365143|SUPERIORITY_OR_OTHER|||||||0.02||95.0||||Change from Week 2 to Week 12 p-value|Mixed-Effects Model Repeated-Measures|||||||0.020
72426510|NCT00337662|144365144|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Fisher Exact|||||||<0.001
72426511|NCT00337662|144365145|SUPERIORITY_OR_OTHER|||||||0.604||95.0|||||Fisher Exact|||||||0.604
72426512|NCT00337662|144365146|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Fisher Exact|||||||<0.001
72426513|NCT00337662|144365147|SUPERIORITY_OR_OTHER|||||||0.745||95.0|||||Fisher Exact|||||||0.745
72426514|NCT00337662|144365148|SUPERIORITY_OR_OTHER|||||||0.474||95.0|||||Fisher Exact|||||||0.474
72426515|NCT00337662|144365149|SUPERIORITY_OR_OTHER|||||||0.034||95.0||||P-values (Change from Baseline) are based on Type III sums of squares from ANOVA model: change = group pooled investigator.|ANOVA|||||||0.034
72426516|NCT00337662|144365149|SUPERIORITY_OR_OTHER|||||||0.125||95.0||||P-values (Change from Baseline) are based on Type III sums of squares from ANOVA model: change = group pooled investigator.|ANOVA|||||||0.125
72426517|NCT00337662|144365150|SUPERIORITY_OR_OTHER||||||>|0.05||95.0||||All comparisons between EO-RIS and NEO-RIS and between NEO-RIS and NEO-OLZ had p-values greater than 0.05.|Fisher Exact|||||||>0.05
72426518|NCT00337662|144365151|SUPERIORITY_OR_OTHER|||||||0.355||95.0|||||ANOVA|p-value is from ANOVA with treatment and pooled investigator in the model.||||||0.355
72426519|NCT00337662|144365151|SUPERIORITY_OR_OTHER|||||||0.244||95.0|||||ANOVA|p-value is from ANOVA with treatment and pooled investigator in the model.||||||0.244
72426520|NCT00337662|144365152|SUPERIORITY_OR_OTHER|||||||0.998||95.0|||||ANOVA|P-value is from ANOVA with treatment and pooled investigator in the model.||||||0.998
72426521|NCT00337662|144365152|SUPERIORITY_OR_OTHER|||||||0.505||95.0|||||ANOVA|P-value is from ANOVA with treatment and pooled investigator in the model.||||||0.505
72426522|NCT00337662|144365153|SUPERIORITY_OR_OTHER|||||||0.266||95.0|||||ANOVA|P-value is from ANOVA with treatment and pooled investigator in the model.||||||0.266
72426523|NCT00337662|144365153|SUPERIORITY_OR_OTHER|||||||0.015||95.0|||||ANOVA|P-value is from ANOVA with treatment and pooled investigator in the model.||||||0.015
72426524|NCT00337662|144365154|SUPERIORITY_OR_OTHER|||||||0.14||95.0||||P-values (Change from Baseline) are based on Type III sums of squares from ANOVA model: change = group pooled investigator.|ANOVA|||||||0.140
72426525|NCT00337662|144365154|SUPERIORITY_OR_OTHER|||||||0.181||95.0||||P-values (Change from Baseline) are based on Type III sums of squares from ANOVA model: change = group pooled investigator.|ANOVA|||||||0.181
72426526|NCT00337662|144365155|SUPERIORITY_OR_OTHER|||||||0.254||95.0||||P-values (Change from Baseline) are based on Type III sums of squares from ANOVA model: change = group pooled investigator.|ANOVA|||||||0.254
72426527|NCT00337662|144365155|SUPERIORITY_OR_OTHER|||||||0.299||95.0|||||ANOVA|P-values (Change from Baseline) are based on Type III sums of squares from ANOVA model: change = group pooled investigator.||||||0.299
72426528|NCT00337662|144365156|SUPERIORITY_OR_OTHER|||||||0.291||95.0||||P-values (Change from Baseline) are based on Type III sums of squares from ANOVA model: change = group pooled investigator.|ANOVA|||||||0.291
72426529|NCT00337662|144365156|SUPERIORITY_OR_OTHER|||||||0.259||95.0||||P-values (Change from Baseline) are based on Type III sums of squares from ANOVA model: change = group pooled investigator.|ANOVA|||||||0.259
72426530|NCT00337662|144365157|SUPERIORITY_OR_OTHER|||||||0.209||95.0||||P-values (Change from Baseline) are based on Type III sums of squares from ANOVA model: change = group pooled investigator.|ANOVA|||||||0.209
72426531|NCT00337662|144365157|SUPERIORITY_OR_OTHER|||||||0.411||95.0||||P-values (Change from Baseline) are based on Type III sums of squares from ANOVA model: change = group pooled investigator.|ANOVA|||||||0.411
72426532|NCT00337662|144365158|SUPERIORITY_OR_OTHER|||||||0.544||95.0||||P-values (Change from Baseline) are based on Type III sums of squares from ANOVA model: change = group pooled investigator.|ANOVA|||||||0.544
72426533|NCT00337662|144365158|SUPERIORITY_OR_OTHER|||||||0.386||95.0||||P-values (Change from Baseline) are based on Type III sums of squares from ANOVA model: change = group pooled investigator.|ANOVA|||||||0.386
72426534|NCT00337662|144365159|SUPERIORITY_OR_OTHER|||||||0.026||95.0||||P-values (Change from Baseline) are based on Type III sums of squares from ANOVA model: change = group pooled investigator.|ANOVA|||||||0.026
72426535|NCT00337662|144365159|SUPERIORITY_OR_OTHER|||||||0.143||95.0||||P-values (Change from Baseline) are based on Type III sums of squares from ANOVA model: change = group pooled investigator.|ANOVA|||||||0.143
72426536|NCT03691948|144365164|SUPERIORITY|||||||0.531|||||||ANOVA|||||||.531
72426537|NCT03691948|144365165|SUPERIORITY|||||||0.076|||||||ANOVA|||||||0.076
72426538|NCT00180713|144365223|SUPERIORITY|||||||0.028|||||||ANOVA|||||||0.028
72426539|NCT00180713|144365224|SUPERIORITY|||||||0.86|||||||ANOVA|||Analysis was performed by intention to treat at 6 months and per protocol at 12 months. Missing variables were replaced with medians or means (for variables missing at baseline) or with expected variables calculated on the percentage change between baseline and 24 weeks observed for the group (placebo or statin) as a whole (a technique called imputation). Missing variables accounted for less than 5% of the data and there were no missing CMR data at baseline.||||0.86
72426540|NCT00180713|144365225|SUPERIORITY|||||||0.4|||||||ANOVA|||Analysis was performed by intention to treat at 6 months and per protocol at 12 months. Missing variables were replaced with medians or means (for variables missing at baseline) or with expected variables calculated on the percentage change between baseline and 24 weeks observed for the group (placebo or statin) as a whole (a technique called imputation). Missing variables accounted for less than 5% of the data and there were no missing CMR data at baseline.||||0.4
72426541|NCT00180713|144365226|SUPERIORITY|||||||0.041|||||||ANOVA|||||||0.041
72426542|NCT00180713|144365227|SUPERIORITY|||||||0.26|||||||ANOVA|||||||0.26
72426543|NCT00610701|144365228|SUPERIORITY_OR_OTHER||||||>|0.05|||||||t-test, 1 sided|||||||>0.05
72426544|NCT01152294|144365229|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.6|STANDARD_DEVIATION|2.4||0.01|TWO_SIDED|95.0|1.02|7.96|||t-test, 2 sided|||We tested for a difference in the mean total knowledge score between the decision aid and control groups using independent t-test (2 sided). With 100 patients in each arm, the study had more than 90% power to detect a 10% difference in knowledge assuming a common standard deviation of 18%.||7.96|1.02|0.01
72335990|NCT05538312|144195041|OTHER|Mixed Model|Ratio (%) of Adjusted Geometric Means|168.9|||||TWO_SIDED|90.0|157.66|180.94|||||The ratios (and 90% CIs) are expressed as percentages.|ARV-471 administered alone as Reference, ARV-471 administered after multiple doses of itraconazole as Test. Natural log transformed AUCinf was analyzed using a mixed effect model with treatment as a fixed effect and participant as a random effect. Estimates of the adjusted mean differences (Test-Reference) and corresponding 90% CIs were obtained from the model and were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||180.94|157.66|
72335991|NCT05538312|144195042|OTHER|Mixed Model|Ratio (%) of Adjusted Geometric Means|152.19|||||TWO_SIDED|90.0|136.9|169.18|||||The ratios (and 90% CIs) are expressed as percentages.|ARV-471 administered alone as Reference, ARV-471 administered after multiple doses of itraconazole as Test. Natural log transformed Cmax was analyzed using a mixed effect model with treatment as a fixed effect and participant as a random effect. Estimates of the adjusted mean differences (Test-Reference) and corresponding 90% CIs were obtained from the model and were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||169.18|136.90|
72335992|NCT05538312|144195043|OTHER|Mixed Model|Ratio (%) of Adjusted Geometric Means|161.99|||||TWO_SIDED|90.0|148.7|176.47|||||The ratios (and 90% CIs) are expressed as percentages.|ARV-471 administered alone as Reference, ARV-471 administered after multiple doses of itraconazole as Test. Natural log transformed AUC120 was analyzed using a mixed effect model with treatment as a fixed effect and participant as a random effect. Estimates of the adjusted mean differences (Test-Reference) and corresponding 90% CIs were obtained from the model and were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||176.47|148.70|
72335993|NCT05538312|144195044|OTHER|Mixed Model|Ratio (%) of Adjusted Geometric Means|153.13|||||TWO_SIDED|90.0|138.51|169.3|||||The ratios (and 90% CIs) are expressed as percentages.|ARV-471 administered alone as Reference, ARV-471 administered after multiple doses of itraconazole as Test. Natural log transformed Cmax was analyzed using a mixed effect model with treatment as a fixed effect and participant as a random effect. Estimates of the adjusted mean differences (Test-Reference) and corresponding 90% CIs were obtained from the model and were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||169.30|138.51|
72426545|NCT04921969|144365255|SUPERIORITY||Odds Ratio (OR)|4.74||||0.0001|TWO_SIDED|95.0|1.951|13.315||The unadjusted p-values between each treatment group and vehicle were calculated based on Exact Logistic Regression including treatment and stratification factors to test the treatment difference.|Exact Logistic Regression|||||13.315|1.951|0.0001
72335994|NCT05538312|144195045|OTHER|Mixed Model|Ratio (%) of Adjusted Geometric Means|171.63|||||TWO_SIDED|90.0|159.96|184.15|||||The ratios (and 90% CIs) are expressed as percentages.|ARV-471 administered alone as Reference, ARV-471 administered after multiple doses of itraconazole as Test. Natural log transformed AUClast was analyzed using a mixed effect model with treatment as a fixed effect and participant as a random effect. Estimates of the adjusted mean differences (Test-Reference) and corresponding 90% CIs were obtained from the model and were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||184.15|159.96|
72335995|NCT05538312|144195046|OTHER|Mixed Model|Ratio (%) of Adjusted Geometric Means|157.8|||||TWO_SIDED|90.0|146.51|169.95|||||The ratios (and 90% CIs) are expressed as percentages.|ARV-471 administered alone as Reference, ARV-471 administered after multiple doses of itraconazole as Test. Natural log transformed AUC120 was analyzed using a mixed effect model with treatment as a fixed effect and participant as a random effect. Estimates of the adjusted mean differences (Test-Reference) and corresponding 90% CIs were obtained from the model and were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||169.95|146.51|
72335996|NCT05538312|144195051|OTHER|Mixed Model|Ratio (%) of Adjusted Geometric Means|192.86|||||TWO_SIDED|90.0|178.86|207.94|||||The ratios (and 90% CIs) are expressed as percentages.|ARV-471 administered alone as Reference, ARV-471 administered after multiple doses of itraconazole as Test. Natural log transformed AUClast was analyzed using a mixed effect model with treatment as a fixed effect and participant as a random effect. Estimates of the adjusted mean differences (Test-Reference) and corresponding 90% CIs were obtained from the model and were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||207.94|178.86|
72335997|NCT03571672|144195059|SUPERIORITY|Difference between Echo Enhanced and Echo Unenhanced|Mean Difference (Final Values)|-0.08|STANDARD_DEVIATION|5.98||0.868|TWO_SIDED||||||t-test, 2 sided|Paired t-test||||||0.868
72335998|NCT03571672|144195059|SUPERIORITY|Difference between Echo Enhanced and Echo Unenhanced|Mean Difference (Final Values)|-0.23|STANDARD_DEVIATION|5.445||0.606|TWO_SIDED||||||t-test, 2 sided|Paired t-test||||||0.606
72426546|NCT04921969|144365255|SUPERIORITY||Odds Ratio (OR)|10.72|||<|0.0001|TWO_SIDED|95.0|4.429|30.042||The unadjusted p-values between each treatment group and vehicle were calculated based on Exact Logistic Regression including treatment and stratification factors to test the treatment difference.|Exact Logistic Regression|||||30.042|4.429|<0.0001
72426547|NCT04921969|144365256|SUPERIORITY||Odds Ratio (OR)|1.41||||0.4198|TWO_SIDED|95.0|0.61|3.268||The unadjusted p-values between each treatment group and vehicle were calculated based on Exact Logistic Regression including treatment and stratification factors to test the treatment difference.|Exact Logistic Regression|||||3.268|0.610|0.4198
72426548|NCT04921969|144365256|SUPERIORITY||Odds Ratio (OR)|1.8||||0.1685|TWO_SIDED|95.0|0.779|4.174||The unadjusted p-values between each treatment group and vehicle were calculated based on Exact Logistic Regression including treatment and stratification factors to test the treatment difference.|Exact Logistic Regression|||||4.174|0.779|0.1685
72335999|NCT03571672|144195059|SUPERIORITY|Difference between Echo Enhanced and Echo Unenhanced|Mean Difference (Final Values)|-0.43|STANDARD_DEVIATION|4.212||0.224|TWO_SIDED||||||t-test, 2 sided|Paired t-test||||||0.224
72336000|NCT03571672|144195060|SUPERIORITY|Difference between Echo Enhanced and Echo Unenhanced|Mean Difference (Final Values)|0.32|STANDARD_DEVIATION|6.682||0.715|TWO_SIDED||||||t-test, 2 sided|Paired t-test||||||0.715
72336001|NCT03571672|144195060|SUPERIORITY|Difference between Echo Enhanced and Echo Unenhanced|Mean Difference (Final Values)|0.05|STANDARD_DEVIATION|6.526||0.956|TWO_SIDED||||||t-test, 2 sided|Paired t-test||||||0.956
72336002|NCT03571672|144195060|SUPERIORITY|Difference between Echo Enhanced and Echo Unenhanced|Mean Difference (Final Values)|-0.17|STANDARD_DEVIATION|4.584||0.771|TWO_SIDED||||||t-test, 2 sided|Paired t-test||||||0.771
72336003|NCT03571672|144195061|OTHER||Intra-class Correlation Coefficient|0.959|||||TWO_SIDED|95.0|0.944|0.97||||||Inter-Reader Variability Echo Enhanced||0.970|0.944|
72336004|NCT03571672|144195061|OTHER||Intra-class Correlation Coefficient|0.95|||||TWO_SIDED|95.0|0.931|0.964||||||Inter-Reader Variability Echo Unenhanced||0.964|0.931|
72336005|NCT03571672|144195061|OTHER||Intra-class Correlation Coefficient|0.957|||||TWO_SIDED|95.0|0.941|0.969||||||Inter-Reader Variability Echo Enhanced||0.969|0.941|
72336006|NCT03571672|144195061|OTHER||Intra-class Correlation Coefficient|0.934|||||TWO_SIDED|95.0|0.909|0.952||||||Inter-Reader Variability Echo Unenhanced||0.952|0.909|
72336007|NCT03571672|144195061|OTHER||Intra-class Correlation Coefficient|0.961|||||TWO_SIDED|95.0|0.946|0.972||||||Inter-Reader Variability Echo Enhanced||0.972|0.946|
72336008|NCT03571672|144195061|OTHER||Intra-class Correlation Coefficient|0.937|||||TWO_SIDED|95.0|0.913|0.954||||||Inter-Reader Variability Echo Unenhanced||0.954|0.913|
72426549|NCT04424290|144365315|OTHER||Adjusted mean difference|-0.0234|STANDARD_ERROR_OF_MEAN|0.0157|||TWO_SIDED|95.0|-0.0558|0.0089|||||Difference calculated as \[BI\]-\[Sham\].|The Mixed model with repeated measurements (MMRM) model included the fixed, categorical effects of treatment at each visit and the fixed continuous effects of baseline at each visit. Visit were treated as the repeated measure with an unstructured covariance structure used to model the within-patient measurements. The Kenward-Roger approximation was used to estimate denominator degrees of freedom and adjust standard errors.||0.0089|-0.0558|
72336009|NCT03571672|144195062|OTHER||Intra-class Correlation Coefficient|0.988|||||TWO_SIDED|95.0|0.984|0.992||||||Inter-reader Variability End Diastolic Echo Enhanced||0.992|0.984|
72336010|NCT03571672|144195062|OTHER||Intra-class Correlation Coefficient|0.986|||||TWO_SIDED|95.0|0.981|0.99||||||Inter-reader Variability End Diastolic Echo Unenhanced||0.990|0.981|
72426550|NCT04424290|144365316|OTHER||Adjusted mean difference|0.0215|STANDARD_ERROR_OF_MEAN|0.0429|||TWO_SIDED|95.0|-0.067|0.11|||||Difference calculated as \[BI\]-\[Sham\].|The Mixed model with repeated measurements (MMRM) model included the fixed, categorical effects of treatment at each visit and the fixed continuous effects of baseline at each visit. Visit were treated as the repeated measure with an unstructured covariance structure used to model the within-patient measurements. The Kenward-Roger approximation was used to estimate denominator degrees of freedom and adjust standard errors.||0.1100|-0.0670|
72426551|NCT04424290|144365317|OTHER||Adjusted mean difference|-0.0109|STANDARD_ERROR_OF_MEAN|0.0145|||TWO_SIDED|95.0|-0.0412|0.0195|||||Difference calculated as \[BI\]-\[Sham\].|The Mixed model with repeated measurements (MMRM) model included the fixed, categorical effects of treatment at each visit and the fixed continuous effects of baseline at each visit. Visit were treated as the repeated measure with an unstructured covariance structure used to model the within-patient measurements. The Kenward-Roger approximation was used to estimate denominator degrees of freedom and adjust standard errors.||0.0195|-0.0412|
72426552|NCT04424290|144365318|OTHER||Adjusted mean difference|-0.0228|STANDARD_ERROR_OF_MEAN|0.0603|||TWO_SIDED|95.0|-0.1477|0.1021|||||Difference calculated as \[BI\]-\[Sham\].|The Mixed model with repeated measurements (MMRM) model included the fixed, categorical effects of treatment at each visit and the fixed continuous effects of baseline at each visit. Visit were treated as the repeated measure with an unstructured covariance structure used to model the within-patient measurements. The Kenward-Roger approximation was used to estimate denominator degrees of freedom and adjust standard errors.||0.1021|-0.1477|
72426553|NCT04424290|144365319|OTHER||Adjusted mean difference|-1.3|STANDARD_ERROR_OF_MEAN|3.3|||TWO_SIDED|95.0|-8.1|5.5|||||Difference calculated as \[BI\]-\[Sham\].|The Mixed model with repeated measurements (MMRM) model included the fixed, categorical effects of treatment at each visit and the fixed continuous effects of baseline at each visit. Visit were treated as the repeated measure with an unstructured covariance structure used to model the within-patient measurements. The Kenward-Roger approximation was used to estimate denominator degrees of freedom and adjust standard errors.||5.5|-8.1|
72426554|NCT04424290|144365320|OTHER||Adjusted mean difference|4.4|STANDARD_ERROR_OF_MEAN|5.7|||TWO_SIDED|95.0|-7.3|16.2|||||Difference calculated as \[BI\]-\[Sham\].|The Mixed model with repeated measurements (MMRM) model included the fixed, categorical effects of treatment at each visit and the fixed continuous effects of baseline at each visit. Visit were treated as the repeated measure with an unstructured covariance structure used to model the within-patient measurements. The Kenward-Roger approximation was used to estimate denominator degrees of freedom and adjust standard errors.||16.2|-7.3|
72426555|NCT04424290|144365321|OTHER||Adjusted mean difference|-3.3|STANDARD_ERROR_OF_MEAN|3.1|||TWO_SIDED|95.0|-9.6|3.0|||||Difference calculated as \[BI\]-\[Sham\].|The Mixed model with repeated measurements (MMRM) model included the fixed, categorical effects of treatment at each visit and the fixed continuous effects of baseline at each visit. Visit were treated as the repeated measure with an unstructured covariance structure used to model the within-patient measurements. The Kenward-Roger approximation was used to estimate denominator degrees of freedom and adjust standard errors.||3.0|-9.6|
72426556|NCT04424290|144365322|OTHER||Adjusted mean difference|-0.6|STANDARD_ERROR_OF_MEAN|3.3|||TWO_SIDED|95.0|-7.3|6.1|||||Difference calculated as \[BI\]-\[Sham\].|The Mixed model with repeated measurements (MMRM) model included the fixed, categorical effects of treatment at each visit and the fixed continuous effects of baseline at each visit. Visit were treated as the repeated measure with an unstructured covariance structure used to model the within-patient measurements. The Kenward-Roger approximation was used to estimate denominator degrees of freedom and adjust standard errors.||6.1|-7.3|
72426557|NCT04424290|144365323|OTHER||Adjusted mean difference|-2.8|STANDARD_ERROR_OF_MEAN|2.9|||TWO_SIDED|95.0|-8.7|3.1|||||Difference calculated as \[BI\]-\[Sham\].|The Mixed model with repeated measurements (MMRM) model included the fixed, categorical effects of treatment at each visit and the fixed continuous effects of baseline at each visit. Visit were treated as the repeated measure with an unstructured covariance structure used to model the within-patient measurements. The Kenward-Roger approximation was used to estimate denominator degrees of freedom and adjust standard errors.||3.1|-8.7|
72426558|NCT04424290|144365324|OTHER||Adjusted mean difference|0.2|STANDARD_ERROR_OF_MEAN|2.5|||TWO_SIDED|95.0|-4.9|5.4|||||Difference calculated as \[BI\]-\[Sham\].|The Mixed model with repeated measurements (MMRM) model included the fixed, categorical effects of treatment at each visit and the fixed continuous effects of baseline at each visit. Visit were treated as the repeated measure with an unstructured covariance structure used to model the within-patient measurements. The Kenward-Roger approximation was used to estimate denominator degrees of freedom and adjust standard errors.||5.4|-4.9|
72426559|NCT04424290|144365325|OTHER||Adjusted mean difference|2.6|STANDARD_ERROR_OF_MEAN|2.6|||TWO_SIDED|95.0|-2.7|7.9|||||Difference calculated as \[BI\]-\[Sham\].|The Mixed model with repeated measurements (MMRM) model included the fixed, categorical effects of treatment at each visit and the fixed continuous effects of baseline at each visit. Visit were treated as the repeated measure with an unstructured covariance structure used to model the within-patient measurements. The Kenward-Roger approximation was used to estimate denominator degrees of freedom and adjust standard errors.||7.9|-2.7|
72336011|NCT03571672|144195062|OTHER||Intra-class Correlation Coefficient|0.96|||||TWO_SIDED|95.0|0.945|0.971||||||Inter-reader Variability End Diastolic Echo Enhanced||0.971|0.945|
72426560|NCT04424290|144365326|OTHER||Adjusted mean difference|7.7|STANDARD_ERROR_OF_MEAN|4.3|||TWO_SIDED|95.0|-1.2|16.5|||||Difference calculated as \[BI\]-\[Sham\].|The Mixed model with repeated measurements (MMRM) model included the fixed, categorical effects of treatment at each visit and the fixed continuous effects of baseline at each visit. Visit were treated as the repeated measure with an unstructured covariance structure used to model the within-patient measurements. The Kenward-Roger approximation was used to estimate denominator degrees of freedom and adjust standard errors.||16.5|-1.2|
72426561|NCT04424290|144365327|OTHER||Adjusted mean difference|13.8|STANDARD_ERROR_OF_MEAN|7.8|||TWO_SIDED|95.0|-2.3|29.8|||||Difference calculated as \[BI\]-\[Sham\].|The Mixed model with repeated measurements (MMRM) model included the fixed, categorical effects of treatment at each visit and the fixed continuous effects of baseline at each visit. Visit were treated as the repeated measure with an unstructured covariance structure used to model the within-patient measurements. The Kenward-Roger approximation was used to estimate denominator degrees of freedom and adjust standard errors.||29.8|-2.3|
72426562|NCT04424290|144365328|OTHER||Adjusted mean difference|6.8|STANDARD_ERROR_OF_MEAN|3.7|||TWO_SIDED|95.0|-0.9|14.5|||||Difference calculated as \[BI\]-\[Sham\].|The Mixed model with repeated measurements (MMRM) model included the fixed, categorical effects of treatment at each visit and the fixed continuous effects of baseline at each visit. Visit were treated as the repeated measure with an unstructured covariance structure used to model the within-patient measurements. The Kenward-Roger approximation was used to estimate denominator degrees of freedom and adjust standard errors.||14.5|-0.9|
72426563|NCT04249336|144365339|SUPERIORITY||Mean Difference (Net)|36.0|||<|0.05|TWO_SIDED|95.0||||Threshold for statistical significance was p \<0.05.|ANOVA||Treatment difference in percent = BioMin F- Colgate Total|It was calculated that 140 participants randomized in a 1:1:1:1 fashion between the four arms would have at least 80 % power to detect a difference of 0.20 mean scores between four treatments from baseline to week 4. Sample size was determined using PAS V.11, two independent sample t-test with 95% confidence interval.||||<0.05
72426564|NCT04249336|144365339|SUPERIORITY||Mean Difference (Net)|33.0|||<|0.05|TWO_SIDED|95.0||||Threshold P\<0.05|ANOVA||Treatment difference in percent = Colgate Sensitive Pro relief - Colgate Total|||||<0.05
72426565|NCT04249336|144365339|SUPERIORITY||Mean Difference (Net)|23.0|||<|0.05|TWO_SIDED|95.0||||Threshold for statistical significance was p \<0.05.|ANOVA||Treatment difference in percent = Sensodyne Rapid Action - Colgate Total|||||<0.05
72426566|NCT04249336|144365340|SUPERIORITY||Mean Difference (Net)|32.0|||<|0.05|TWO_SIDED|95.0||||Threshold for statistical significance was p \<0.05.|ANCOVA||Treatment difference in percent = BioMin F- Colgate Total|It was calculated that 140 participants randomized in a 1:1:1:1 fashion between the four arms would have at least 80 % power to detect a difference of 0.20 mean scores between four treatments from baseline to week 4. Sample size was determined using PAS V.11, two independent sample t-test with 95% confidence interval.||||<0.05
72426567|NCT04249336|144365340|SUPERIORITY||Mean Difference (Net)|39.0|||<|0.05|TWO_SIDED|||||Threshold for statistical significance was p \<0.05.|ANOVA||Treatment difference in percent = Colgate Sensitive Pro relief - Colgate Total|||||<0.05
72426568|NCT04249336|144365340|SUPERIORITY||Mean Difference (Net)|30.0|||<|0.05|TWO_SIDED|||||Threshold for statistical significance was p \<0.05.|ANOVA||Treatment difference in percent = Sensodyne Rapid Action - Colgate Total|||||<0.05
72426569|NCT04249336|144365341|SUPERIORITY||Median Difference (Net)|36.0|||<|0.05|TWO_SIDED|95.0||||Threshold for statistical significance was p \<0.05.|ANCOVA||Treatment difference in percent = BioMin F- Colgate Total|It was calculated that 140 participants randomized in a 1:1:1:1 fashion between the four arms would have at least 80 % power to detect a difference of 0.20 mean scores between four treatments from baseline to week 4. Sample size was determined using PAS V.11, two independent sample t-test with 95% confidence interval.||||<0.05
72426570|NCT04249336|144365341|SUPERIORITY||Mean Difference (Net)|28.0|||<|0.05|TWO_SIDED|95.0||||Threshold for statistical significance was p \<0.05.|ANOVA||Treatment difference in percent = Colgate Sensitive Pro relief - Colgate Total|||||<0.05
72426571|NCT04249336|144365341|SUPERIORITY||Mean Difference (Net)|25.0|||<|0.05|TWO_SIDED|95.0||||Threshold for statistical significance was p \<0.05.|ANOVA||Treatment difference in percent = Sensodyne Rapid Action - Colgate Total|||||<0.05
72426572|NCT01242176|144365342|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability|Geometric Mean Ratio|101.67|STANDARD_DEVIATION|6.7|||TWO_SIDED|90.0|98.1|105.37|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment.|Standard deviation is actually the geometric coefficient of variation (gCV).|Ratio calculated as empa final formulation divided by empa trial formulation 2||105.37|98.10|
72426573|NCT01242176|144365343|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability|Geometric Mean Ratio|99.46|STANDARD_DEVIATION|18.7|||TWO_SIDED|90.0|90.18|109.68|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment.|Standard deviation is actually the gCV.|Ratio calculated as empa final formulation divided by empa trial formulation 2||109.68|90.18|
72336012|NCT03571672|144195062|OTHER||Intra-class Correlation Coefficient|0.925|||||TWO_SIDED|95.0|0.897|0.945||||||Inter-reader Variability End Diastolic Echo Unenhanced||0.945|0.897|
72426574|NCT01242176|144365344|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability|Geometric Mean Ratio|101.8|STANDARD_DEVIATION|6.7|||TWO_SIDED|90.0|98.26|105.48|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment.|Standard deviation is actually the gCV.|Ratio calculated as empa final formulation divided by empa trial formulation 2||105.48|98.26|
72426575|NCT03390036|144365345|SUPERIORITY|||||||0.8106|||||||ANOVA|||||||0.8106
72426576|NCT03390036|144365346|SUPERIORITY|||||||0.3007|||||||ANOVA|||||||0.3007
72426577|NCT03390036|144365347|SUPERIORITY|||||||0.6354|||||||ANOVA|||||||0.6354
72426578|NCT03390036|144365348|SUPERIORITY|||||||0.5754|||||||ANOVA|||||||0.5754
72426579|NCT03390036|144365349|SUPERIORITY|||||||0.4759|||||||ANOVA|||||||0.4759
72426580|NCT03390036|144365350|SUPERIORITY|||||||0.5596|||||||ANOVA|||||||0.5596
72426581|NCT03390036|144365351|SUPERIORITY|||||||0.4551|||||||ANOVA|||||||0.4551
72426582|NCT03390036|144365352|SUPERIORITY|||||||0.7931|||||||ANOVA|||||||0.7931
72426583|NCT00358215|144365353|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.01||||0.871|TWO_SIDED|95.0|0.9|1.13||Stratification factors are: region and type of device (cardiac resynchronization therapy (CRT) with or without implantable cardioverter defibrillator (ICD), ICD without CRT, or none)|Stratified Log Rank||The hazard ratio and 95% confidence intervals are from the Cox proportional hazards model adjusted by the stratification factors.|||1.13|0.90|0.871
72336013|NCT03571672|144195062|OTHER||Intra-class Correlation Coefficient|0.97|||||TWO_SIDED|95.0|0.958|0.978||||||Inter-reader Variability End Diastolic Echo Enhanced||0.978|0.958|
72336014|NCT03571672|144195062|OTHER||Intra-class Correlation Coefficient|0.909|||||TWO_SIDED|95.0|0.876|0.934||||||Inter-reader Variability End Diastolic Echo Unenhanced||0.934|0.876|
72336015|NCT03571672|144195062|OTHER||Intra-class Correlation Coefficient|0.989|||||TWO_SIDED|95.0|0.984|0.992||||||Inter-reader Variability End Systolic Echo Enhanced||0.992|0.984|
72336016|NCT03571672|144195062|OTHER||Intra-class Correlation Coefficient|0.985|||||TWO_SIDED|95.0|0.979|0.989||||||Inter-reader Variability End Systolic Echo Unenhanced||0.989|0.979|
72336017|NCT03571672|144195062|OTHER||Intra-class Correlation Coefficient|0.973|||||TWO_SIDED|95.0|0.962|0.98||||||Inter-reader Variability End Systolic Echo Enhanced||0.980|0.962|
72336018|NCT03571672|144195062|OTHER||Intra-class Correlation Coefficient|0.947|||||TWO_SIDED|95.0|0.927|0.961||||||Inter-reader Variability End Systolic Echo Unenhanced||0.961|0.927|
72336019|NCT03571672|144195062|OTHER||Intra-class Correlation Coefficient|0.977|||||TWO_SIDED|95.0|0.969|0.984||||||Inter-reader Variability End Systolic Echo Enhanced||0.984|0.969|
72336020|NCT03571672|144195062|OTHER||Intra-class Correlation Coefficient|0.937|||||TWO_SIDED|95.0|0.914|0.954||||||Inter-reader Variability End Systolic Echo Unenhanced||0.954|0.914|
72336021|NCT03571672|144195063|OTHER||Intra-class Correlation Coefficient|0.945|||||TWO_SIDED|95.0|0.909|0.967||||||Inter-Reader Variability Echo Enhanced Sub-Optimal Echocardiograms||0.967|0.909|
72336022|NCT03571672|144195063|OTHER||Intra-class Correlation Coefficient|0.917|||||TWO_SIDED|95.0|0.864|0.95||||||Inter-Reader Variability Echo Unenhanced Sub-Optimal Echocardiograms||0.950|0.864|
72336023|NCT03571672|144195063|OTHER||Intra-class Correlation Coefficient|0.939|||||TWO_SIDED|95.0|0.9|0.963||||||Inter-Reader Variability Echo Enhanced Sub-Optimal Echocardiograms||0.963|0.900|
72336024|NCT03571672|144195063|OTHER||Intra-class Correlation Coefficient|0.894|||||TWO_SIDED|95.0|0.827|0.935||||||Inter-Reader Variability Echo Unenhanced Sub-Optimal Echocardiograms||0.935|0.827|
72336025|NCT03571672|144195063|OTHER||Intra-class Correlation Coefficient|0.952|||||TWO_SIDED|95.0|0.92|0.971||||||Inter-Reader Variability Echo Enhanced Sub-Optimal Echocardiograms||0.971|0.920|
72336026|NCT03571672|144195063|OTHER||Intra-class Correlation Coefficient|0.9|||||TWO_SIDED|95.0|0.838|0.939||||||Inter-Reader Variability Echo Unenhanced Sub-Optimal Echocardiograms||0.939|0.838|
72336027|NCT03571672|144195064|OTHER||Intra-class Correlation Coefficient|0.976|||||TWO_SIDED|95.0|0.961|0.986||||||Inter-reader Variability End Diastolic Echo Enhanced||0.986|0.961|
72336028|NCT03571672|144195064|OTHER||Intra-class Correlation Coefficient|0.984|||||TWO_SIDED|95.0|0.974|0.991||||||Inter-reader Variability End Diastolic Echo Unenhanced||0.991|0.974|
72336029|NCT03571672|144195064|OTHER||Intra-class Correlation Coefficient|0.933|||||TWO_SIDED|95.0|0.89|0.96||||||Inter-reader Variability End Diastolic Echo Enhanced||0.960|0.890|
72336030|NCT03571672|144195064|OTHER||Intra-class Correlation Coefficient|0.857|||||TWO_SIDED|95.0|0.77|0.912||||||Inter-reader Variability End Diastolic Echo Unenhanced||0.912|0.770|
72336031|NCT03571672|144195064|OTHER||Intra-class Correlation Coefficient|0.948|||||TWO_SIDED|95.0|0.914|0.969||||||Inter-reader Variability End Diastolic Echo Enhanced||0.969|0.914|
72336032|NCT03571672|144195064|OTHER||Intra-class Correlation Coefficient|0.824|||||TWO_SIDED|95.0|0.721|0.892||||||Inter-reader Variability End Diastolic Echo Unenhanced||0.892|0.721|
72336033|NCT03571672|144195064|OTHER||Intra-class Correlation Coefficient|0.982|||||TWO_SIDED|95.0|0.97|0.989||||||Inter-reader Variability End Systolic Echo Enhanced||0.989|0.970|
72336034|NCT03571672|144195064|OTHER||Intra-class Correlation Coefficient|0.974|||||TWO_SIDED|95.0|0.957|0.985||||||Inter-reader Variability End Systolic Echo Unenhanced||0.985|0.957|
72336035|NCT03571672|144195064|OTHER||Intra-class Correlation Coefficient|0.948|||||TWO_SIDED|95.0|0.915|0.969||||||Inter-reader Variability End Systolic Echo Enhanced||0.969|0.915|
72336036|NCT03571672|144195064|OTHER||Intra-class Correlation Coefficient|0.89|||||TWO_SIDED|95.0|0.822|0.933||||||Inter-reader Variability End Systolic Echo Unenhanced||0.933|0.822|
72336037|NCT03571672|144195064|OTHER||Intra-class Correlation Coefficient|0.959|||||TWO_SIDED|95.0|0.932|0.975||||||Inter-reader Variability End Systolic Echo Enhanced||0.975|0.932|
72336038|NCT03571672|144195064|OTHER||Intra-class Correlation Coefficient|0.872|||||TWO_SIDED|95.0|0.794|0.922||||||Inter-reader Variability End Systolic Echo Unenhanced||0.922|0.794|
72336039|NCT00303446|144195065|SUPERIORITY_OR_OTHER|||||||0.28||95.0|||||Generalized estimating equation model|The analysis includes percent change from baseline at 12 and 24 months.||||||0.28
72336040|NCT00303446|144195066|SUPERIORITY_OR_OTHER|||||||0.86||95.0|||||Generalized estimating equation model|The analysis includes change from baseline at 12 and 24 months.||||||0.86
72336041|NCT00303446|144195067|SUPERIORITY_OR_OTHER|||||||0.47||95.0|||||Generalized estimating equation model|The analysis includes change from baseline at 12 and 24 months.||Comparison of changes from baseline in manual muscle testing results.||||0.47
72336042|NCT00303446|144195068|SUPERIORITY_OR_OTHER|||||||0.13||95.0|||||Generalized estimating equation model|The analysis includes change from baseline at 12 and 24 months.||||||0.13
72336043|NCT00303446|144195069|SUPERIORITY_OR_OTHER|||||||0.46||95.0|||||Generalized estimating equation model|The analysis includes change from baseline at 12 and 24 months.||||||0.46
72426584|NCT00358215|144365354|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.04||||0.512|TWO_SIDED|95.0|0.92|1.19||Stratification factors are: region and type of device (cardiac resynchronization therapy (CRT) with or without implantable cardioverter defibrillator (ICD), ICD without CRT, or none).|Stratified Log Rank||The hazard ratio and 95% confidence intervals are from the Cox proportional hazards model adjusted by the stratification factors.|||1.19|0.92|0.512
72426585|NCT00358215|144365355|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.01||||0.922|TWO_SIDED|95.0|0.89|1.14||Stratification factors are: region and type of device (cardiac resynchronization therapy (CRT) with or without implantable cardioverter defibrillator (ICD), ICD without CRT, or none).|Stratified Log Rank||The hazard ratio and 95% confidence intervals are from the Cox proportional hazards model adjusted by the stratification factors.|||1.14|0.89|0.922
72426586|NCT00358215|144365356|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|2.2|STANDARD_ERROR_OF_MEAN|0.79||0.005|TWO_SIDED|95.0|0.65|3.75|||Mixed Models Analysis|Mixed effects model estimating treatment effect adjusted for region, type of device, and Baseline KCCQ score.||||3.75|0.65|0.005
72426587|NCT00358215|144365357|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|2.29|STANDARD_ERROR_OF_MEAN|0.9||0.011|TWO_SIDED|95.0|0.53|4.05|||Mixed Models Analysis|Mixed effects model estimating treatment effect adjusted for region, type of device, and Baseline KCCQ score.||||4.05|0.53|0.011
72426588|NCT01087723|144365400|SUPERIORITY_OR_OTHER||Relative risk|0.6||||0.0014|TWO_SIDED|95.0|0.43|0.82|||Chi-squared|||||0.82|0.43|0.0014
72426589|NCT00806624|144365418|SUPERIORITY_OR_OTHER||difference in percentages|-3.5|||||TWO_SIDED|95.0|-16.2|9.4||||||||9.4|-16.2|
72426590|NCT00806624|144365418|SUPERIORITY_OR_OTHER||difference in percentages|-9.1|||||TWO_SIDED|95.0|-22.4|4.5||||||||4.5|-22.4|
72426591|NCT00806624|144365418|SUPERIORITY_OR_OTHER||difference in percentage|-5.6|||||TWO_SIDED|95.0|-19.3|8.2||||||||8.2|-19.3|
72426592|NCT00574990|144365459|SUPERIORITY_OR_OTHER||chi square|12.99|STANDARD_ERROR_OF_MEAN|1.4||0.01|TWO_SIDED|||||Differences between roles and communication event content were assessed by Chi squared|Chi-squared|||Descriptive counts and chi squared were done on the observation data.||||0.01
72426593|NCT01355419|144365461|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||t-test, 2 sided|||A power analysis conducted prior to the study predicted that a sample of 144 patients would provide an 80% power to detect a mean difference in sleep time of 40 minutes, assuming a standard deviation of 85 minutes and using a two-sided significance level of 5%.||||<0.05
72426594|NCT01355419|144365462|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|||||Multiple regression modelling was used to determine whether actigraphic or polysomnographic data were predictors for physical activity, independently from age and BMI, stepwise forward selection of variables was performed.|Regression, Linear|||Multiple regression modelling was used to determine whether actigraphic or polysomnographic data were predictors for physical activity, independently from age and BMI, stepwise forward selection of variables was performed.||||<0.05
72426595|NCT01751113|144365508|SUPERIORITY_OR_OTHER||AUC ratio|1.158|||<|0.001|TWO_SIDED|95.0|1.1|1.219|||Mixed Models Analysis|||||1.219|1.100|<0.001
72426596|NCT01751113|144365508|SUPERIORITY_OR_OTHER||AUC ratio|1.288|||<|0.001|TWO_SIDED|95.0|1.224|1.355|||Mixed Models Analysis|||||1.355|1.224|<0.001
72426597|NCT01751113|144365509|SUPERIORITY_OR_OTHER||AUC ratio|0.856|||<|0.001|TWO_SIDED|95.0|0.812|0.902|||Mixed Models Analysis|||||0.902|0.812|<0.001
72426598|NCT01751113|144365509|SUPERIORITY_OR_OTHER||AUC ratio|0.774|||<|0.001|TWO_SIDED|95.0|0.735|0.816|||Mixed Models Analysis|||||0.816|0.735|<0.001
72426599|NCT01751113|144365510|SUPERIORITY_OR_OTHER||specific airway conductance ratio|1.181|||<|0.001|TWO_SIDED|95.0|1.104|1.263|||Mixed Models Analysis||Statistical data for 30 minutes|||1.263|1.104|<0.001
72426600|NCT01751113|144365510|SUPERIORITY_OR_OTHER||specific airway conductance ratio|1.303|||<|0.001|TWO_SIDED|95.0|1.219|1.393|||Mixed Models Analysis||Statistical data for 30 minutes|||1.393|1.219|<0.001
72426601|NCT01751113|144365510|SUPERIORITY_OR_OTHER||specific airway conductance ratio|1.175|||<|0.001|TWO_SIDED|95.0|1.099|1.257|||Mixed Models Analysis||Statistical data for 75 minutes|||1.257|1.099|<0.001
72426602|NCT01751113|144365510|SUPERIORITY_OR_OTHER||specific airway conductance ratio|1.34|||<|0.001|TWO_SIDED|95.0|1.253|1.432|||Mixed Models Analysis||Statistical data for 75 minutes|||1.432|1.253|<0.001
72336044|NCT00303446|144195070|SUPERIORITY_OR_OTHER|||||||0.11||95.0|||||Generalized estimating equation model|The analysis includes change from baseline at 12 and 24 months.||||||0.11
72426603|NCT01751113|144365510|SUPERIORITY_OR_OTHER||specific airway conductance ratio|1.151|||<|0.001|TWO_SIDED|95.0|1.076|1.231|||Mixed Models Analysis||Statistical data for 120 minutes|||1.231|1.076|<0.001
72426604|NCT01751113|144365510|SUPERIORITY_OR_OTHER||specific airway conductance ratio|1.301|||<|0.001|TWO_SIDED|95.0|1.217|1.391|||Mixed Models Analysis||Statistical data for 120 minutes|||1.391|1.217|<0.001
72426605|NCT01751113|144365510|SUPERIORITY_OR_OTHER||specific airway conductance ratio|1.141|||<|0.001|TWO_SIDED|95.0|1.067|1.22|||Mixed Models Analysis||Statistical data for 240 minutes|||1.220|1.067|<0.001
72426606|NCT01751113|144365510|SUPERIORITY_OR_OTHER||specific airway conductance ratio|1.239|||<|0.001|TWO_SIDED|95.0|1.159|1.325|||Mixed Models Analysis||Statistical data for 240 minutes|||1.325|1.159|<0.001
72426607|NCT01751113|144365511|SUPERIORITY_OR_OTHER||specific airway conductance ratio|0.846|||<|0.001|TWO_SIDED|95.0|0.792|0.905|||Mixed Models Analysis||Statistical data for 30 minutes|||0.905|0.792|<0.001
72426608|NCT01751113|144365511|SUPERIORITY_OR_OTHER||specific airway conductance ratio|0.767|||<|0.001|TWO_SIDED|95.0|0.717|0.819|||Mixed Models Analysis||Statistical data for 30 minutes|||0.819|0.717|<0.001
72426609|NCT01751113|144365511|SUPERIORITY_OR_OTHER||specific airway conductance ratio|0.85|||<|0.001|TWO_SIDED|95.0|0.795|0.909|||Mixed Models Analysis||Statistical data for 75 minutes|||0.909|0.795|<0.001
72426610|NCT01751113|144365511|SUPERIORITY_OR_OTHER||specific airway conductance ratio|0.746|||<|0.001|TWO_SIDED|95.0|0.698|0.798|||Mixed Models Analysis||Statistical data for 75 minutes|||0.798|0.698|<0.001
72426611|NCT01751113|144365511|SUPERIORITY_OR_OTHER||specific airway conductance ratio|0.868|||<|0.001|TWO_SIDED|95.0|0.812|0.928|||Mixed Models Analysis||Statistical data for 120 minutes|||0.928|0.812|<0.001
72426612|NCT01751113|144365511|SUPERIORITY_OR_OTHER||specific airway conductance ratio|0.769|||<|0.001|TWO_SIDED|95.0|0.719|0.822|||Mixed Models Analysis||Statistical data for 120 minutes|||0.822|0.719|<0.001
72426613|NCT01751113|144365511|SUPERIORITY_OR_OTHER||specific airway conductance ratio|0.877|||<|0.001|TWO_SIDED|95.0|0.82|0.938|||Mixed Models Analysis||Statistical data for 240 minutes|||0.938|0.820|<0.001
72426614|NCT01751113|144365511|SUPERIORITY_OR_OTHER||specific airway conductance ratio|0.809|||<|0.001|TWO_SIDED|95.0|0.757|0.865|||Mixed Models Analysis||Statistical data for 240 minutes|||0.865|0.757|<0.001
72426615|NCT01751113|144365512|SUPERIORITY_OR_OTHER||Mean difference of FEV1|0.157|||<|0.001|TWO_SIDED|95.0|0.116|0.198|||Mixed Models Analysis||Statistical data for FEV1|||0.198|0.116|<0.001
72426616|NCT01751113|144365512|SUPERIORITY_OR_OTHER||Mean difference of FEV1|0.118|||<|0.001|TWO_SIDED|95.0|0.077|0.159|||Mixed Models Analysis||Statistical data for FEV1|||0.159|0.077|<0.001
72426617|NCT01751113|144365512|SUPERIORITY_OR_OTHER||Mean difference of FVC|0.082||||0.002|TWO_SIDED|95.0|0.031|0.133|||Mixed Models Analysis||Statistical data for FVC|||0.133|0.031|0.002
72426618|NCT01751113|144365512|SUPERIORITY_OR_OTHER||Mean difference of FVC|0.135|||<|0.001|TWO_SIDED|95.0|0.084|0.186|||Mixed Models Analysis||Statistical data for FVC|||0.186|0.084|<0.001
72426619|NCT01751113|144365512|SUPERIORITY_OR_OTHER||Mean difference of IC|0.054||||0.035|TWO_SIDED|95.0|0.004|0.104|||Mixed Models Analysis||Statistical data for IC|||0.104|0.004|0.035
72426620|NCT01751113|144365512|SUPERIORITY_OR_OTHER||Mean difference of IC|0.064||||0.011|TWO_SIDED|95.0|0.015|0.114|||Mixed Models Analysis||Statistical data for IC|||0.114|0.015|0.011
72426621|NCT01751113|144365512|SUPERIORITY_OR_OTHER||Mean difference of RV|-0.107||||0.009|TWO_SIDED|95.0|-0.187|-0.028|||Mixed Models Analysis||Statistical data for RV|||-0.028|-0.187|0.009
72336045|NCT00303446|144195071|SUPERIORITY_OR_OTHER|||||||0.08||95.0|||||Generalized estimating equation model|The analysis includes change from baseline at 12 and 24 months.||||||0.08
72336046|NCT00303446|144195072|SUPERIORITY_OR_OTHER|||||||0.73||95.0|||||Generalized estimating equation model|The analysis includes change from baseline at 12 and 24 months.||||||0.73
72336047|NCT00303446|144195073|SUPERIORITY_OR_OTHER|||||||0.37||95.0|||||Generalized estimating equation model|The analysis includes change from baseline at 12 and 24 months.||||||0.37
72336048|NCT00303446|144195074|SUPERIORITY_OR_OTHER|||||||0.65||95.0|||||Generalized estimating equation model|The analysis includes change from baseline at 12 and 24 months.||||||0.65
72336049|NCT00303446|144195075|SUPERIORITY_OR_OTHER|||||||0.99||95.0|||||Generalized estimating equation model|The analysis includes change from baseline at 12 and 24 months.||||||0.99
72336050|NCT00303446|144195076|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Generalized estimating equation model|The analysis includes change from baseline at 12 and 24 months.||||||1.0
72336051|NCT00303446|144195077|SUPERIORITY_OR_OTHER|||||||0.014||95.0|||||Generalized estimating equation model|The analysis includes change from baseline at 12 and 24 months.||||||0.014
72336052|NCT00303446|144195078|SUPERIORITY_OR_OTHER|||||||0.033||95.0||||Generalized estimating equation model showed a significant interaction between time and treatment; therefore a two sample t-test was used at each time point. P-value is given for comparison at 24 months.|t-test, 2 sided|||||||0.033
72336053|NCT00303446|144195079|SUPERIORITY_OR_OTHER|||||||0.61||95.0|||||Generalized estimating equation model|The analysis includes change from baseline at 12 and 24 months.||||||0.61
72336054|NCT00642174|144195083|SUPERIORITY_OR_OTHER||Least Squares Mean Difference (Net)|61.6|||<|0.0001||95.0|53.83|69.31||P-value is for 4 Hours After Loading Dose.|Mixed Models Analysis|Linear mixed model with treatment, sequence and treatment by sequence (i.e. period) as fixed effects and subject as random effect.|Least Squares Mean Difference = Prasugrel minus Clopidogrel.|Null hypothesis: there is no difference between prasugrel and clopidogrel in IPA assessed by Accumetrics VerifyNow™ P2Y12 4 hours after administration of loading dose. Assuming 90% power, 2-sided alpha of 0.05, and a 17.5% difference in IPA between treatment groups with a standard deviation of 20, a total of 15 completed subjects per sequence group (i.e., 15 subject who receive prasugrel first, then clopidogrel; and 15 subjects who receive clopidogrel first, then prasugrel) was determined.||69.31|53.83|<0.0001
72336055|NCT00642174|144195084|SUPERIORITY_OR_OTHER||Mean Difference (Net)|36.5|||<|0.0001||95.0|27.43|45.52||P-value for 1 Hour After Loading Dose. A priori threshold for statistical significance was set at p=0.05 level.|Mixed Models Analysis|Linear mixed model with treatment, sequence and treatment by sequence (ie. period) as fixed effects and subject as random effect.|Least Squares Mean Difference = Prasugrel minus Clopidogrel.|Null hypothesis: there was no difference between prasugrel and clopidogrel in IPA assessed by Accumetrics VerifyNow™ P2Y12 1 hour after administration of the loading dose.||45.52|27.43|<0.0001
72336056|NCT00642174|144195084|SUPERIORITY_OR_OTHER||Mean Difference (Net)|57.9|||<|0.0001||95.0|49.56|66.19||P-value for 24 Hour After Loading Dose. A priori threshold for statistical significance was set at p=0.05 level.|Mixed Models Analysis|Linear mixed model with treatment, sequence and treatment by sequence (ie. period) as fixed effects and subject as random effect.|Least Squares Mean Difference = Prasugrel minus Clopidogrel.|Null hypothesis: there was no difference between prasugrel and clopidogrel in IPA assessed by Accumetrics VerifyNow™ P2Y12 24 hours after administration of the loading dose.||66.19|49.56|<0.0001
72336057|NCT00642174|144195084|SUPERIORITY_OR_OTHER||Mean Difference (Net)|17.7|||<|0.0001||95.0|10.27|25.04||P-value for 24 Hours After Last Maintenance Dose. A priori threshold for statistical significance was set at p=0.05 level.|Mixed Models Analysis|Linear mixed model with treatment, sequence and treatment by sequence (ie. period) as fixed effects and subject as random effect.|Least Squares Mean Difference = Prasugrel minus Clopidogrel.|Null hypothesis: there was no difference between prasugrel and clopidogrel in IPA assessed by Accumetrics VerifyNow™ P2Y12 24 hours post-Last Maintenance Dose (LMD).||25.04|10.27|<0.0001
72336058|NCT00642174|144195085|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.8||||0.5466||95.0|-3.66|1.97||P-value for Baseline (5 uM ADP). A priori threshold for statistical significance was set at p=0.05 level.|Mixed Models Analysis|Linear mixed model with treatment, sequence and treatment by sequence (ie. period) as fixed effects and subject as random effect.|Least Squares Mean Difference = Prasugrel minus Clopidogrel.|The null hypothesis was that there was no difference between prasugrel and clopidogrel in MPA assessed by Light Transmittance Aggregometry (LTA).||1.97|-3.66|0.5466
72336059|NCT00642174|144195085|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-23.0|||<|0.0001||95.0|-28.45|-17.55||P-value for 1 After Post Loading Dose (5 uM ADP). A priori threshold for statistical significance was set at p=0.05 level.|Mixed Models Analysis|Linear mixed model with treatment, sequence and treatment by sequence (ie. period) as fixed effects and subject as random effect.|Least Squares Mean Difference = Prasugrel minus Clopidogrel.|The null hypothesis was that there was no difference between prasugrel and clopidogrel in MPA assessed by Light Transmittance Aggregometry (LTA).||-17.55|-28.45|<0.0001
72336060|NCT00642174|144195085|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-26.6|||<|0.0001||95.0|-31.18|-22.02||P-value for 4 Hour After Loading Dose (5 uM ADP). A priori threshold for statisitical significance was set at p=0.05 level.|Mixed Models Analysis|Linear mixed model with treatment, sequence and treatment by sequence (ie. period) as fixed effects and subject as random effect.|Least Squares Mean Difference = Prasugrel minus Clopidogrel.|The null hypothesis was that there was no difference between prasugrel and clopidogrel in MPA assessed by Light Transmittance Aggregometry (LTA).||-22.02|-31.18|<0.0001
72426622|NCT01751113|144365512|SUPERIORITY_OR_OTHER||Mean difference of RV|-0.102||||0.012|TWO_SIDED|95.0|-0.18|-0.023|||Mixed Models Analysis||Statistical data for RV|||-0.023|-0.180|0.012
72426623|NCT01751113|144365512|SUPERIORITY_OR_OTHER||Mean difference of TLC|-0.013||||0.632|TWO_SIDED|95.0|-0.066|0.04|||Mixed Models Analysis||Statistical data for TLC|||0.040|-0.066|0.632
72426624|NCT01751113|144365512|SUPERIORITY_OR_OTHER||Mean difference of TLC|-0.014||||0.596|TWO_SIDED|95.0|-0.067|0.038|||Mixed Models Analysis||Statistical data for TLC|||0.038|-0.067|0.596
72426625|NCT01751113|144365512|SUPERIORITY_OR_OTHER||Mean difference of TGV|-0.065||||0.028|TWO_SIDED|95.0|-0.123|-0.007|||Mixed Models Analysis||Statistical data for TGV|||-0.007|-0.123|0.028
72426626|NCT01751113|144365512|SUPERIORITY_OR_OTHER||Mean difference of TGV|-0.075||||0.01|TWO_SIDED|95.0|-0.133|-0.018|||Mixed Models Analysis||Statistical data for TGV|||-0.018|-0.133|0.010
72336061|NCT00642174|144195085|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-23.3|||<|0.0001||95.0|-27.42|-19.17||P-value for 24 Hour After Loading Dose (5 uM ADP). A priori threshold for statistical significance was set at p=0.05 level.|Mixed Models Analysis|Linear mixed model with treatment, sequence and treatment by sequence (ie. period) as fixed effects and subject as random effect.|Least Squares Mean Difference = Prasugrel minus Clopidogrel.|The null hypothesis was that there was no difference between prasugrel and clopidogrel in MPA assessed by Light Transmittance Aggregometry (LTA).||-19.17|-27.42|<0.0001
72426627|NCT01751113|144365513|SUPERIORITY_OR_OTHER||FEV1/FVC ratio|0.032|||<|0.001|TWO_SIDED|95.0|0.023|0.041|||Mixed Models Analysis||Statistical data for FEV1/FVC ratio|||0.041|0.023|<0.001
72426628|NCT01751113|144365513|SUPERIORITY_OR_OTHER||FEV1/FVC ratio|0.017|||<|0.001|TWO_SIDED|95.0|0.008|0.026|||Mixed Models Analysis||Statistical data for FEV1/FVC ratio|||0.026|0.008|<0.001
72426629|NCT01751113|144365514|SUPERIORITY_OR_OTHER||specific airway conductance ratio|0.835|||<|0.001|TWO_SIDED|95.0|0.77|0.905|||Mixed Models Analysis|||||0.905|0.770|<0.001
72426630|NCT01751113|144365514|SUPERIORITY_OR_OTHER||specific airway conductance ratio|0.803|||<|0.001|TWO_SIDED|95.0|0.741|0.869|||Mixed Models Analysis|||||0.869|0.741|<0.001
72426631|NCT01751113|144365515|SUPERIORITY_OR_OTHER||specific airway conductance ratio|1.2|||<|0.001|TWO_SIDED|95.0|1.108|1.301|||Mixed Models Analysis|||||1.301|1.108|<0.001
72426632|NCT01751113|144365515|SUPERIORITY_OR_OTHER||specific airway conductance ratio|1.249|||<|0.001|TWO_SIDED|95.0|1.153|1.352|||Mixed Models Analysis|||||1.352|1.153|<0.001
72426633|NCT01751113|144365516|SUPERIORITY_OR_OTHER||Mean difference of FEV1|0.161|||<|0.001|TWO_SIDED|95.0|0.086|0.236|||Mixed Models Analysis||Statistical data for FEV1|||0.236|0.086|<0.001
72426634|NCT01751113|144365516|SUPERIORITY_OR_OTHER||Mean difference of FEV1|0.103||||0.008|TWO_SIDED|95.0|0.028|0.178|||Mixed Models Analysis||Statistical data for FEV1|||0.178|0.028|0.008
72426635|NCT01751113|144365516|SUPERIORITY_OR_OTHER||Mean difference of FVC|0.104||||0.051|TWO_SIDED|95.0|0.0|0.209|||Mixed Models Analysis||Statistical data for FVC|||0.209|0.000|0.051
72426636|NCT01751113|144365516|SUPERIORITY_OR_OTHER||Mean difference of FVC|0.148||||0.006|TWO_SIDED|95.0|0.043|0.253|||Mixed Models Analysis||Statistical data for FVC|||0.253|0.043|0.006
72426637|NCT01751113|144365516|SUPERIORITY_OR_OTHER||Mean difference of IC|-0.008||||0.89|TWO_SIDED|95.0|-0.12|0.104|||Mixed Models Analysis||Statistical data for IC|||0.104|-0.120|0.890
72426638|NCT01751113|144365516|SUPERIORITY_OR_OTHER||Mean difference of IC|-0.008||||0.89|TWO_SIDED|95.0|-0.118|0.103|||Mixed Models Analysis||Statistical data for IC|||0.103|-0.118|0.890
72426639|NCT01751113|144365516|SUPERIORITY_OR_OTHER||Mean difference of RV|-0.229|||<|0.001|TWO_SIDED|95.0|-0.355|-0.103|||Mixed Models Analysis||Statistical data for RV|||-0.103|-0.355|<0.001
72426640|NCT01751113|144365516|SUPERIORITY_OR_OTHER||Mean difference of RV|-0.189||||0.003|TWO_SIDED|95.0|-0.314|-0.064|||Mixed Models Analysis||Statistical data for RV|||-0.064|-0.314|0.003
72426641|NCT01751113|144365516|SUPERIORITY_OR_OTHER||Mean difference of TLC|-0.101||||0.055|TWO_SIDED|95.0|-0.204|0.002|||Mixed Models Analysis||Statistical data for TLC|||0.002|-0.204|0.055
72426642|NCT01751113|144365516|SUPERIORITY_OR_OTHER||Mean difference of TLC|-0.105||||0.044|TWO_SIDED|95.0|-0.206|-0.003|||Mixed Models Analysis||Statistical data for TLC|||-0.003|-0.206|0.044
72426643|NCT01751113|144365516|SUPERIORITY_OR_OTHER||Mean difference of TGV|-0.092||||0.085|TWO_SIDED|95.0|-0.197|0.013|||Mixed Models Analysis||Statistical data for TGV|||0.013|-0.197|0.085
72426644|NCT01751113|144365516|SUPERIORITY_OR_OTHER||Mean difference of TGV|-0.091||||0.083|TWO_SIDED|95.0|-0.195|0.012|||Mixed Models Analysis||Statistical data for TGV|||0.012|-0.195|0.083
72426645|NCT01751113|144365517|SUPERIORITY_OR_OTHER||FEV1/FVC ratio|0.027|||<|0.001|TWO_SIDED|95.0|0.014|0.041|||Mixed Models Analysis||Statistical data for FEV1/FVC ratio|||0.041|0.014|<0.001
72426646|NCT01751113|144365517|SUPERIORITY_OR_OTHER||FEV1/FVC ratio|0.008||||0.223|TWO_SIDED|95.0|-0.005|0.021|||Mixed Models Analysis||Statistical data for FEV1/FVC ratio|||0.021|-0.005|0.223
72426647|NCT03657264|144365530|NON_INFERIORITY|The upper limit of the 90% confidence interval was expected lower to the margin of 10 milliseconds for all tests.|Least Squares Mean Difference|0.73|STANDARD_ERROR_OF_MEAN|1.18|||TWO_SIDED|90.0|-1.23|2.69||p-value is not shown, as this is a non-inferiority study.|ANCOVA|Each timepoint was tested through a separate model.||For the timepoint 5 min||2.69|-1.23|
72426648|NCT03657264|144365530|NON_INFERIORITY|The upper limit of the 90% confidence interval was expected lower to the margin of 10 milliseconds for all tests.|Least Squares Mean Difference|0.48|STANDARD_ERROR_OF_MEAN|1.09|||TWO_SIDED|90.0|-1.32|2.29||p-value is not shown, as this is a non-inferiority study.|ANCOVA|Each timepoint was tested through a separate model.||For the timepoint 10 min||2.29|-1.32|
72426649|NCT03657264|144365530|NON_INFERIORITY|The upper limit of the 90% confidence interval was expected lower to the margin of 10 milliseconds for all tests.|Least Squares Mean Difference|0.16|STANDARD_ERROR_OF_MEAN|1.16|||TWO_SIDED|90.0|-1.76|2.08||p-value is not shown, as this is a non-inferiority study.|ANCOVA|Each timepoint was tested through a separate model.||For the timepoint 20 min||2.08|-1.76|
72426650|NCT03657264|144365530|NON_INFERIORITY|The upper limit of the 90% confidence interval was expected lower to the margin of 10 milliseconds for all tests.|Least Squares Mean Difference|0.63|STANDARD_ERROR_OF_MEAN|1.04|||TWO_SIDED|90.0|-1.09|2.35||p-value is not shown, as this is a non-inferiority study.|ANCOVA|Each timepoint was tested through a separate model.||For the timepoint 30 min||2.35|-1.09|
72426651|NCT03657264|144365530|NON_INFERIORITY|The upper limit of the 90% confidence interval was expected lower to the margin of 10 milliseconds for all tests.|Least Squares Mean Difference|0.18|STANDARD_ERROR_OF_MEAN|1.25|||TWO_SIDED|90.0|-1.88|2.25||p-value is not shown, as this is a non-inferiority study.|ANCOVA|Each timepoint was tested through a separate model.||For the timepoint 1 hour||2.25|-1.88|
72426652|NCT03657264|144365530|NON_INFERIORITY|The upper limit of the 90% confidence interval was expected lower to the margin of 10 milliseconds for all tests.|Least Squares Mean Difference|0.45|STANDARD_ERROR_OF_MEAN|1.16|||TWO_SIDED|90.0|-1.47|2.37||p-value is not shown, as this is a non-inferiority study.|ANCOVA|Each timepoint was tested through a separate model.||For the timepoint 1.5 hours||2.37|-1.47|
72426653|NCT03657264|144365530|NON_INFERIORITY|The upper limit of the 90% confidence interval was expected lower to the margin of 10 milliseconds for all tests.|Least Squares Mean Difference|-0.03|STANDARD_ERROR_OF_MEAN|1.18|||TWO_SIDED|90.0|-1.99|1.92||p-value is not shown, as this is a non-inferiority study.|ANCOVA|Each timepoint was tested through a separate model.||For the timepoint 2 hours||1.92|-1.99|
72426654|NCT03657264|144365530|NON_INFERIORITY|The upper limit of the 90% confidence interval was expected lower to the margin of 10 milliseconds for all tests.|Least Squares Mean Difference|2.39|STANDARD_ERROR_OF_MEAN|1.23|||TWO_SIDED|90.0|0.35|4.43||p-value is not shown, as this is a non-inferiority study.|ANCOVA|Each timepoint was tested through a separate model.||For the timepoint 3 hours||4.43|0.35|
72426655|NCT03657264|144365530|NON_INFERIORITY|The upper limit of the 90% confidence interval was expected lower to the margin of 10 milliseconds for all tests.|Least Squares Mean Difference|0.27|STANDARD_ERROR_OF_MEAN|1.11|||TWO_SIDED|90.0|-1.57|2.12||p-value is not shown, as this is a non-inferiority study.|ANCOVA|Each timepoint was tested through a separate model.||For the timepoint 4 hours||2.12|-1.57|
72426656|NCT03657264|144365530|NON_INFERIORITY|The upper limit of the 90% confidence interval was expected lower to the margin of 10 milliseconds for all tests.|Least Squares Mean Difference|1.11|STANDARD_ERROR_OF_MEAN|1.36|||TWO_SIDED|90.0|-1.15|3.37||p-value is not shown, as this is a non-inferiority study.|ANCOVA|Each timepoint was tested through a separate model.||For the timepoint 8 hours||3.37|-1.15|
72426657|NCT03657264|144365530|NON_INFERIORITY|The upper limit of the 90% confidence interval was expected lower to the margin of 10 milliseconds for all tests.|Least Squares Mean Difference|0.31|STANDARD_ERROR_OF_MEAN|1.1|||TWO_SIDED|90.0|-1.52|2.14||p-value is not shown, as this is a non-inferiority study.|ANCOVA|Each timepoint was tested through a separate model.||For the timepoint 24 hours||2.14|-1.52|
72426658|NCT03657264|144365530|NON_INFERIORITY|The upper limit of the 90% confidence interval was expected lower to the margin of 10 milliseconds for all tests.|Least Squares Mean Difference|4.81|STANDARD_ERROR_OF_MEAN|1.19|||TWO_SIDED|90.0|2.84|6.78||p-value is not shown, as this is a non-inferiority study.|ANCOVA|Each timepoint was tested through a separate model.||For the timepoint 5 min||6.78|2.84|
72426659|NCT03657264|144365530|NON_INFERIORITY|The upper limit of the 90% confidence interval was expected lower to the margin of 10 milliseconds for all tests.|Least Squares Mean Difference|1.93|STANDARD_ERROR_OF_MEAN|1.09|||TWO_SIDED|90.0|0.12|3.73||p-value is not shown, as this is a non-inferiority study.|ANCOVA|Each timepoint was tested through a separate model.||For the timepoint 10 min||3.73|0.12|
72426660|NCT03657264|144365530|NON_INFERIORITY|The upper limit of the 90% confidence interval was expected lower to the margin of 10 milliseconds for all tests.|Least Squares Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|1.16|||TWO_SIDED|90.0|-1.71|2.12||p-value is not shown, as this is a non-inferiority study.|ANCOVA|Each timepoint was tested through a separate model.||For the timepoint 20 min||2.12|-1.71|
72426661|NCT03657264|144365530|NON_INFERIORITY|The upper limit of the 90% confidence interval was expected lower to the margin of 10 milliseconds for all tests.|Least Squares Mean Difference|0.43|STANDARD_ERROR_OF_MEAN|1.04|||TWO_SIDED|90.0|-1.29|2.15||p-value is not shown, as this is a non-inferiority study.|ANCOVA|Each timepoint was tested through a separate model.||For the timepoint 30 min||2.15|-1.29|
72426662|NCT03657264|144365530|NON_INFERIORITY|The upper limit of the 90% confidence interval was expected lower to the margin of 10 milliseconds for all tests.|Least Squares Mean Difference|0.47|STANDARD_ERROR_OF_MEAN|1.25|||TWO_SIDED|90.0|-1.6|2.53||p-value is not shown, as this is a non-inferiority study.|ANCOVA|Each timepoint was tested through a separate model.||For the timepoint 1 hour||2.53|-1.60|
72426663|NCT03657264|144365530|NON_INFERIORITY|The upper limit of the 90% confidence interval was expected lower to the margin of 10 milliseconds for all tests.|Least Squares Mean Difference|-1.11|STANDARD_ERROR_OF_MEAN|1.16|||TWO_SIDED|90.0|-3.03|0.81||p-value is not shown, as this is a non-inferiority study.|ANCOVA|Each timepoint was tested through a separate model.||For the timepoint 1.5 hours||0.81|-3.03|
72426664|NCT03657264|144365530|NON_INFERIORITY|The upper limit of the 90% confidence interval was expected lower to the margin of 10 milliseconds for all tests.|Least Squares Mean Difference|-1.17|STANDARD_ERROR_OF_MEAN|1.18|||TWO_SIDED|90.0|-3.13|0.78||p-value is not shown, as this is a non-inferiority study.|ANCOVA|Each timepoint was tested through a separate model.||For the timepoint 2 hours||0.78|-3.13|
72426665|NCT03657264|144365530|NON_INFERIORITY|The upper limit of the 90% confidence interval was expected lower to the margin of 10 milliseconds for all tests.|Least Squares Mean Difference|-1.33|STANDARD_ERROR_OF_MEAN|1.23|||TWO_SIDED|90.0|-3.36|0.71||p-value is not shown, as this is a non-inferiority study.|ANCOVA|Each timepoint was tested through a separate model.||For the timepoint 3 hours||0.71|-3.36|
72426666|NCT03657264|144365530|NON_INFERIORITY|The upper limit of the 90% confidence interval was expected lower to the margin of 10 milliseconds for all tests.|Least Squares Mean Difference|-0.85|STANDARD_ERROR_OF_MEAN|1.11|||TWO_SIDED|90.0|-2.69|1.0||p-value is not shown, as this is a non-inferiority study.|ANCOVA|Each timepoint was tested through a separate model.||For the timepoint 4 hours||1.00|-2.69|
72426667|NCT03657264|144365530|NON_INFERIORITY|The upper limit of the 90% confidence interval was expected lower to the margin of 10 milliseconds for all tests.|Least Squares Mean Difference|-1.94|STANDARD_ERROR_OF_MEAN|1.36|||TWO_SIDED|90.0|-4.19|0.32||p-value is not shown, as this is a non-inferiority study.|ANCOVA|Each timepoint was tested through a separate model.||For the timepoint 8 hours||0.32|-4.19|
72426668|NCT03657264|144365530|NON_INFERIORITY|The upper limit of the 90% confidence interval was expected lower to the margin of 10 milliseconds for all tests.|Least Squares Mean Difference|0.21|STANDARD_ERROR_OF_MEAN|1.11|||TWO_SIDED|90.0|-1.62|2.04||p-value is not shown, as this is a non-inferiority study.|ANCOVA|Each timepoint was tested through a separate model.||For the timepoint 24 hours||2.04|-1.62|
72426669|NCT03657264|144365531|SUPERIORITY|The lower limit of the adjusted confidence interval was expected upper to the margin of 5 milliseconds.|Least Squares Mean Difference|4.62|STANDARD_ERROR_OF_MEAN|1.23|||TWO_SIDED|90.0|2.58|6.66||p-value is not shown, as this is a non-inferiority study.|ANCOVA|As multiple timepoints were examined separately, the overall type I error rate needed to be adjusted.||For the timepoint 1 hour||6.66|2.58|
72426670|NCT03657264|144365531|SUPERIORITY|The lower limit of the adjusted confidence interval was expected upper to the margin of 5 milliseconds.|Least Squares Mean Difference|9.4|STANDARD_ERROR_OF_MEAN|1.14|||TWO_SIDED|90.0|7.14|11.66||p-value is not shown, as this is a non-inferiority study.|ANCOVA|As multiple timepoints were examined separately, the overall type I error rate needed to be adjusted.||For the timepoint 1.5 hours||11.66|7.14|
72426671|NCT03657264|144365531|SUPERIORITY|The lower limit of the adjusted confidence interval was expected upper to the margin of 5 milliseconds.|Least Squares Mean Difference|10.55|STANDARD_ERROR_OF_MEAN|1.16|||TWO_SIDED|90.0|7.92|13.17||p-value is not shown, as this is a non-inferiority study.|ANCOVA|As multiple timepoints were examined separately, the overall type I error rate needed to be adjusted.||For the timepoint 2 hours||13.17|7.92|
72426672|NCT03657264|144365531|SUPERIORITY|The lower limit of the adjusted confidence interval was expected upper to the margin of 5 milliseconds.|Least Squares Mean Difference|10.33|STANDARD_ERROR_OF_MEAN|1.22|||TWO_SIDED|90.0|7.7|12.95||p-value is not shown, as this is a non-inferiority study.|ANCOVA|As multiple timepoints were examined separately, the overall type I error rate needed to be adjusted.||For the timepoint 3 hours||12.95|7.70|
72426673|NCT03657264|144365531|SUPERIORITY|The lower limit of the adjusted confidence interval was expected upper to the margin of 5 milliseconds.|Least Squares Mean Difference|10.65|STANDARD_ERROR_OF_MEAN|1.1|||TWO_SIDED|90.0|8.05|13.25||p-value is not shown, as this is a non-inferiority study.|ANCOVA|As multiple timepoints were examined separately, the overall type I error rate needed to be adjusted.||For the timepoint 4 hours||13.25|8.05|
72426674|NCT00924469|144365533|SUPERIORITY_OR_OTHER||Adjusted mean ratio|0.61||||0.0216||90.0|0.429|0.865||Test for no difference of natural log transformed values between treatments was calculated using two-way analysis of variance (ANOVA) adjusting for Baseline risk factor.|ANOVA|||Statistical Analysis 1 for testosterone concentration at Week 12||0.865|0.429|0.0216
72426675|NCT00924469|144365534|SUPERIORITY_OR_OTHER||Adjusted mean ratio|1.43||||0.1423||90.0|0.956|2.145||Test for no difference of natural log transformed values between treatments was calculated using two-way ANOVA adjusting for Baseline risk factor.|ANOVA|||Statistical Analysis 1 for testosterone concentration at Week 24||2.145|0.956|0.1423
72426676|NCT00924469|144365534|SUPERIORITY_OR_OTHER||Adjusted mean ratio|0.82||||0.6639||90.0|0.386|1.746||Test for no difference of natural log transformed values between treatments was calculated using two-way ANOVA adjusting for Baseline risk factor.|ANOVA|||Statistical Analysis 2 for DHT concentration at Week 24||1.746|0.386|0.6639
72426677|NCT00924469|144365535|SUPERIORITY_OR_OTHER||Adjusted mean ratio|0.32|||<|0.0001||90.0|0.239|0.418||Test for no difference of natural log transformed values between treatments was calculated using two-way ANOVA adjusting for Baseline risk factor.|ANOVA|||Statistical Analysis 1 for androstenedione concentration at Week 12||0.418|0.239|<0.0001
72426678|NCT00924469|144365535|SUPERIORITY_OR_OTHER||Adjusted mean ratio|1.13||||0.5061||90.0|0.828|1.554||Test for no difference of natural log transformed values between treatments was calculated using two-way ANOVA adjusting for Baseline risk factor.|ANOVA|||Statistical Analysis 2 for androstenedione concentration at Week 24||1.554|0.828|0.5061
72426679|NCT00924469|144365535|SUPERIORITY_OR_OTHER||Adjusted mean ratio|0.03|||<|0.0001||90.0|0.017|0.05||Test for no difference of natural log transformed values between treatments was calculated using two-way ANOVA adjusting for Baseline risk factor.|ANOVA|||Statistical Analysis 3 for DHEA concentration at Week 12||0.050|0.017|<0.0001
72426680|NCT00924469|144365535|SUPERIORITY_OR_OTHER||Adjusted mean ratio|0.79||||0.5767||90.0|0.398|1.581||Test for no difference of natural log transformed values between treatments was calculated using two-way ANOVA adjusting for Baseline risk factor.|ANOVA|||Statistical Analysis 4 for DHEA concentration at Week 24||1.581|0.398|0.5767
72426681|NCT00924469|144365536|SUPERIORITY_OR_OTHER||Adjusted mean ratio|0.14|||<|0.0001||90.0|0.097|0.207||Test for no difference of natural log transformed values between treatments was calculated using analysis of covariance (ANCOVA) adjusting for Baseline risk factor and Baseline androgen.|ANCOVA|||Statistical Analysis 1 for serum testosterone concentration at Week 12||0.207|0.097|<0.0001
72426682|NCT00924469|144365536|SUPERIORITY_OR_OTHER||Adjusted mean ratio|0.84||||0.4364||90.0|0.571|1.225||Test for no difference of natural log transformed values between treatments was calculated using ANCOVA adjusting for Baseline risk factor and Baseline androgen.|ANCOVA|||Statistical Analysis 2 for serum testosterone concentration at Week 24||1.225|0.571|0.4364
72426683|NCT00924469|144365536|SUPERIORITY_OR_OTHER||Adjusted mean ratio|0.75||||0.1515||90.0|0.54|1.044||Test for no difference of natural log transformed values between treatments was calculated using ANCOVA adjusting for Baseline risk factor and Baseline androgen.|ANCOVA|||Statistical Analysis 3 for serum DHT concentration at Week 12||1.044|0.540|0.1515
72426684|NCT00924469|144365536|SUPERIORITY_OR_OTHER||Adjusted mean ratio|0.84||||0.3965||90.0|0.589|1.188||Test for no difference of natural log transformed values between treatments was calculated using ANCOVA adjusting for Baseline risk factor and Baseline androgen.|ANCOVA|||Statistical Analysis 4 for serum DHT concentration at Week 24||1.188|0.589|0.3965
72426685|NCT00924469|144365536|SUPERIORITY_OR_OTHER||Adjusted mean ratio|0.42||||0.0003||90.0|0.29|0.615||Test for no difference of natural log transformed values between treatments was calculated using ANCOVA adjusting for Baseline risk factor and Baseline androgen.|ANCOVA|||Statistical Analysis 5 for serum Androsterone concentration at Week 12||0.615|0.290|0.0003
72426686|NCT00924469|144365536|SUPERIORITY_OR_OTHER||Adjusted mean ratio|1.22||||0.2494||90.0|0.916|1.625||Test for no difference of natural log transformed values between treatments was calculated using ANCOVA adjusting for Baseline risk factor and Baseline androgen.|ANCOVA|||Statistical Analysis 6 for serum androsterone concentration at Week 24||1.625|0.916|0.2494
72426687|NCT00924469|144365536|SUPERIORITY_OR_OTHER||Adjusted mean ratio|0.04|||<|0.0001||90.0|0.023|0.073||Test for no difference of natural log transformed values between treatments was calculated using ANCOVA adjusting for Baseline risk factor and Baseline androgen.|ANCOVA|||Statistical Analysis 7 for serum DHEA concentration at Week 12||0.073|0.023|<0.0001
72426688|NCT00924469|144365536|SUPERIORITY_OR_OTHER||Adjusted mean ratio|1.24||||0.5144||90.0|0.717|2.137||Test for no difference of natural log transformed values between treatments was calculated using ANCOVA adjusting for Baseline risk factor and Baseline androgen.|ANCOVA|||Statistical Analysis 8 for serum DHEA concentration at Week 24||2.137|0.717|0.5144
72336062|NCT00642174|144195085|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-8.7||||0.0001||95.0|-12.78|-4.58||P-value for 24 Hour After Last Maintenance Dose (5 uM ADP). A priori threshold for statistical significance was set at p=0.05 level.|Mixed Models Analysis|Linear mixed model with treatment, sequence and treatment by sequence (ie. period) as fixed effects and subject as random effect.|Least Squares Mean Difference = Prasugrel minus Clopidogrel.|The null hypothesis was that there was no difference between prasugrel and clopidogrel in MPA assessed by Light Transmittance Aggregometry (LTA).||-4.58|-12.78|0.0001
72336063|NCT00642174|144195085|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.2||||0.8779||95.0|-2.8|3.26||P-value for Baseline (20 uM ADP). A priori threshold for statistical significance was set at p=0.05 level.|Mixed Models Analysis|Linear mixed model with treatment, sequence and treatment by sequence (ie. period) as fixed effects and subject as random effect.|Least Squares Mean Difference = Prasugrel minus Clopidogrel.|The null hypothesis was that there was no difference between prasugrel and clopidogrel in MPA assessed by Light Transmittance Aggregometry (LTA).||3.26|-2.80|0.8779
72336064|NCT00642174|144195085|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-25.2|||<|0.0001||95.0|-32.43|-17.87||P-value for 1 Hour After Loading Dose (20 uM ADP). A priori threshold for statistical significance was set at p=0.05 level.|Mixed Models Analysis|Linear mixed model with treatment, sequence and treatment by sequence (ie. period) as fixed effects and subject as random effect.|Least Squares Mean Difference = Prasugrel minus Clopidogrel.|The null hypothesis was that there was no difference between prasugrel and clopidogrel in MPA assessed by Light Transmittance Aggregometry (LTA).||-17.87|-32.43|<0.0001
72336065|NCT00642174|144195085|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-35.1|||<|0.0001||95.0|-40.32|-29.78||P-value for 4 Hour After Loading Dose (20 uM ADP). A priori threshold for statistical significance was set at p=0.05 level.|Mixed Models Analysis|Linear mixed model with treatment, sequence and treatment by sequence (ie. period) as fixed effects and subject as random effect.|Least Squares Mean Difference = Prasugrel minus Clopidogrel.|The null hypothesis was that there was no difference between prasugrel and clopidogrel in MPA assessed by Light Transmittance Aggregometry (LTA).||-29.78|-40.32|<0.0001
72336066|NCT00642174|144195085|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-31.0|||<|0.0001||95.0|-36.32|-25.66||P-value for 24 Hour After Loading Dose (20 uM ADP). A priori threshold for statistical significance was set at p=0.05 level.|Mixed Models Analysis|Linear mixed model with treatment, sequence and treatment by sequence (ie. period) as fixed effects and subject as random effect.|Least Squares Mean Difference = Prasugrel minus Clopidogrel.|The null hypothesis was that there was no difference between prasugrel and clopidogrel in MPA assessed by Light Transmittance Aggregometry (LTA).||-25.66|-36.32|<0.0001
72336067|NCT00642174|144195085|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-12.4|||<|0.0001||95.0|-17.19|-7.58||P-value for 24 Hour After Last Maintenance Dose (20 uM ADP). A priori threshold for statistical significance was set at p=0.05 level.|Mixed Models Analysis|Linear mixed model with treatment, sequence and treatment by sequence (ie. period) as fixed effects and subject as random effect.|Least Squares Mean Difference = Prasugrel minus Clopidogrel.|The null hypothesis was that there was no difference between prasugrel and clopidogrel in MPA assessed by Light Transmittance Aggregometry (LTA).||-7.58|-17.19|<0.0001
72336068|NCT00642174|144195086|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.9||||0.3692||95.0|-3.6|9.44||P-value for Baseline. A priori threshold for statistical significance was set at p=0.05 level.|Mixed Models Analysis|Linear mixed model with treatment, sequence and treatment by sequence (ie. period) as fixed effects and subject as random effect.|Least Squares Mean Difference = Prasugrel minus Clopidogrel.|The null hypothesis was that there was no difference between prasugrel and clopidogrel in Inhibition of Platelet Function as assessed by VASP.||9.44|-3.60|0.3692
72426689|NCT00924469|144365536|SUPERIORITY_OR_OTHER||Adjusted mean ratio|0.1|||<|0.0001||90.0|0.055|0.189||Test for no difference of natural log transformed values between treatments was calculated using ANCOVA adjusting for Baseline risk factor and Baseline androgen.|ANCOVA|||Statistical Analysis 9 for serum DHEA-glucuronide concentration at Week 12||0.189|0.055|<0.0001
72336069|NCT00642174|144195086|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-36.2|||<|0.0001||95.0|-47.43|-24.98||P-value for 1 Hour After Loading Dose. A priori threshold for statistical significance was set at p=0.05 level.|Mixed Models Analysis|Linear mixed model with treatment, sequence and treatment by sequence (ie. period) as fixed effects and subject as random effect.|Least Squares Mean Difference = Prasugrel minus Clopidogrel.|The null hypothesis was that there was no difference between prasugrel and clopidogrel in Inhibition of Platelet Function as assessed by VASP.||-24.98|-47.43|<0.0001
72336070|NCT00642174|144195086|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-53.0|||<|0.0001||95.0|-61.89|-44.02||P-value for 4 Hours After Loading Dose. A priori threshold for statistical significance was set at p=0.05 level.|Mixed Models Analysis|Linear mixed model with treatment, sequence and treatment by sequence (ie. period) as fixed effects and subject as random effect.|Least Squares Mean Difference = Prasugrel minus Clopidogrel.|The null hypothesis was that there was no difference between prasugrel and clopidogrel in Inhibition of Platelet Function as assessed by VASP.||-44.02|-61.89|<0.0001
72336071|NCT00642174|144195086|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-42.8|||<|0.0001||95.0|-50.03|-35.55||P-value for 24 Hours After Loading Dose. A priori threshold for statistical significance was set at p=0.05 level.|Mixed Models Analysis|Linear mixed model with treatment, sequence and treatment by sequence (ie. period) as fixed effects and subject as random effect.|Least Squares Mean Difference = Prasugrel minus Clopidogrel.|The null hypothesis was that there was no difference between prasugrel and clopidogrel in Inhibition of Platelet Function as assessed by VASP.||-35.55|-50.03|<0.0001
72426690|NCT00924469|144365536|SUPERIORITY_OR_OTHER||Adjusted mean ratio|0.55||||0.1329||90.0|0.286|1.06||Test for no difference of natural log transformed values between treatments was calculated using ANCOVA adjusting for Baseline risk factor and Baseline androgen.|ANCOVA|||Statistical Analysis 10 for serum DHEA-glucuronide concentration at Week 24||1.060|0.286|0.1329
72426691|NCT00924469|144365536|SUPERIORITY_OR_OTHER||Adjusted mean ratio|0.01|||<|0.0001||90.0|0.008|0.028||Test for no difference of natural log transformed values between treatments was calculated using ANCOVA adjusting for Baseline risk factor and Baseline androgen.|ANCOVA|||Statistical Analysis 11 for serum DHEA-sulfate concentration at Week 12||0.028|0.008|<0.0001
72336072|NCT00642174|144195086|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-14.9||||0.0012||95.0|-23.42|-6.37||P-value for 24 Hours After Last Maintenance Dose. A priori threshold for statistical significance was set to p=0.05 level.|Mixed Models Analysis|Linear mixed model with treatment, sequence and treatment by sequence (ie. period) as fixed effects and subject as random effect.|Least Squares Mean Difference = Prasugrel minus Clopidogrel.|The null hypothesis was that there was no difference between prasugrel and clopidogrel in Inhibition of Platelet Function as assessed by VASP.||-6.37|-23.42|0.0012
72336073|NCT00642174|144195087|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.3||||0.5238||95.0|-5.35|2.78||P-value for Baseline. A priori threshold for statistical significance was set at p=0.05 level.|Mixed Models Analysis|Linear mixed model with treatment, sequence and treatment by sequence (ie. period) as fixed effects and subject as random effect.|Least Squares Mean Difference = Prasugrel minus Clopidogrel.|Null hypothesis: no difference between prasugrel and clopidogrel in Inhibition of Platelet Function as measured by Thromboelastography (TEG)-Platelet Mapping Maximum Amplitude - Adenosine Diphosphate (ADP).||2.78|-5.35|0.5238
72336074|NCT00642174|144195087|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-16.2|||<|0.0001||95.0|-21.15|-11.33||P-value for 1 Hour After Loading Dose. A priori threshold for statistical significance was set at p=0.05 level.|Mixed Models Analysis|Linear mixed model with treatment, sequence and treatment by sequence (ie. period) as fixed effects and subject as random effect.|Least Squares Mean Difference = Prasugrel minus Clopidogrel.|Null hypothesis: no difference between prasugrel and clopidogrel in Inhibition of Platelet Function as measured by Thromboelastography (TEG)-Platelet Mapping Maximum Amplitude - Adenosine Diphosphate (ADP).||-11.33|-21.15|<0.0001
72336075|NCT00642174|144195087|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-23.9|||<|0.0001||95.0|-29.67|-18.11||P-value for 4 Hours After Loading Dose. A priori threshold for statistical significance was set at p=0.05 level.|Mixed Models Analysis|Linear mixed model with treatment, sequence and treatment by sequence (ie. period) as fixed effects and subject as random effect.|Least Squares Mean Difference = Prasugrel minus Clopidogrel.|Null hypothesis: no difference between prasugrel and clopidogrel in Inhibition of Platelet Function as measured by Thromboelastography (TEG)-Platelet Mapping Maximum Amplitude - Adenosine Diphosphate (ADP).||-18.11|-29.67|<0.0001
72336076|NCT00642174|144195087|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-19.9|||<|0.0001||95.0|-24.97|-14.9||P-value for 24 Hours After Loading Dose. A priori threshold for statistical significance was set at p=0.05 level.|Mixed Models Analysis|Linear mixed model with treatment, sequence and treatment by sequence (ie. period) as fixed effects and subject as random effect.|Least Squares Mean Difference = Prasugrel minus Clopidogrel.|Null hypothesis: no difference between prasugrel and clopidogrel in Inhibition of Platelet Function as measured by Thromboelastography (TEG)-Platelet Mapping Maximum Amplitude - Adenosine Diphosphate (ADP).||-14.90|-24.97|<0.0001
72336077|NCT00642174|144195087|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.6||||0.3725||95.0|-8.46|3.26||P-value for 24 Hours After Last Maintenance Dose. A priori threshold for statistical significance was set at p=0.05 level.|Mixed Models Analysis|Linear mixed model with treatment, sequence and treatment by sequence (ie. period) as fixed effects and subject as random effect.|Least Squares Mean Difference = Prasugrel minus Clopidogrel.|Null hypothesis: no difference between prasugrel and clopidogrel in Inhibition of Platelet Function as measured by Thromboelastography (TEG)-Platelet Mapping Maximum Amplitude - Adenosine Diphosphate (ADP).||3.26|-8.46|0.3725
72336078|NCT00896363|144195088|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.85|||||TWO_SIDED|90.0|-1.62|3.32|||Mixed model repeated measures analysis||The point estimate was calculated as least square mean difference (net values) of HAMD17|Comparison of placebo and GSK163090 1 mg on Day 14||3.32|-1.62|
72336079|NCT00896363|144195088|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.33|||||TWO_SIDED|90.0|-2.12|2.78|||Mixed model repeated measures analysis||The point estimate was calculated as least square mean difference (net values) of HAMD17|Comparison of placebo and GSK163090 3 mg on Day 14||2.78|-2.12|
72336080|NCT00896363|144195088|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.57|||||TWO_SIDED|90.0|-2.01|5.14|||Mixed model repeated measures analysis||The point estimate was calculated as least square mean difference (net values) of HAMD17|Comparison of placebo and GSK163090 1 mg on Day 42||5.14|-2.01|
72336081|NCT00896363|144195088|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.66|||||TWO_SIDED|90.0|-1.81|5.13|||Mixed model repeated measures analysis||The point estimate was calculated as least square mean difference (net values) of HAMD17|Comparison of placebo and GSK163090 3 mg on Day 42||5.13|-1.81|
72336082|NCT00896363|144195089|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.31|||||TWO_SIDED|90.0|-0.93|1.56|||Mixed model repeated measures analysis||The point estimate was calculated as least square mean difference (net values) of BECH 6 scale|Comparison of placebo and GSK163090 1 mg on Day 14||1.56|-0.93|
72336083|NCT00896363|144195089|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.51|||||TWO_SIDED|90.0|-0.73|1.75|||Mixed model repeated measures analysis||The point estimate was calculated as least square mean difference (net values) of BECH 6 scale|Comparison of placebo and GSK163090 3 mg on Day 14||1.75|-0.73|
72336084|NCT00896363|144195089|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.66|||||TWO_SIDED|90.0|-1.1|2.42|||Mixed model repeated measures analysis||The point estimate was calculated as least square mean difference (net values) of BECH 6 scale|Comparison of placebo and GSK163090 1 mg on Day 42||2.42|-1.10|
72336085|NCT00896363|144195089|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.77|||||TWO_SIDED|90.0|-0.93|2.48|||Mixed model repeated measures analysis||The point estimate was calculated as least square mean difference (net values) of BECH 6 scale|Comparison of placebo and GSK163090 3 mg on Day 42||2.48|-0.93|
72336086|NCT00896363|144195090|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.72|||||TWO_SIDED|90.0|-0.94|2.37|||Mixed model repeated measures analysis||The point estimate was calculated as least square mean difference (net values) of QIDS-SR scale|Comparison of placebo and GSK163090 1 mg on Day 14||2.37|-0.94|
72336087|NCT00896363|144195090|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.44|||||TWO_SIDED|90.0|-2.1|1.21|||Mixed model repeated measures analysis||The point estimate was calculated as least square mean difference (net values) of QIDS-SR scale|Comparison of placebo and GSK163090 3 mg on Day 14||1.21|-2.10|
72336088|NCT00896363|144195090|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.84|||||TWO_SIDED|90.0|-1.22|2.9|||Mixed model repeated measures analysis||The point estimate was calculated as least square mean difference (net values) of QIDS-SR scale|Comparison of placebo and GSK163090 1 mg on Day 42||2.90|-1.22|
72336089|NCT00896363|144195090|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.81|||||TWO_SIDED|90.0|-1.22|2.85|||Mixed model repeated measures analysis||The point estimate was calculated as least square mean difference (net values) of QIDS-SR scale|Comparison of placebo and GSK163090 3 mg on Day 42||2.85|-1.22|
72336090|NCT01545232|144195252|SUPERIORITY_OR_OTHER||Adjusted Relative Risk|0.75||||0.12|TWO_SIDED|95.0|0.52|1.08|||Mantel Haenszel|The critical level for significance (p\<0.044) was adjusted for two interim analyses, and all tests were conducted using two-sided tests.||Initial sample size (580) planned to detect a clinically meaningful 10% difference in 24-hour mortality (11% vs. 21%) supported by prior data. Data Safety Monitoring Board (DSMB) increased sample size to 680 according to trial's adaptive design. With 680 pts. \& given the final observed mortality proportions in 1:1:1 group, PROPPR had 95% power to detect the pre-specified 10% difference at 24 hours if such differences existed.||1.08|0.52|0.12
72336091|NCT01545232|144195253|SUPERIORITY_OR_OTHER||Adjusted Relative Risk|0.86||||0.26|TWO_SIDED|95.0|0.65|1.12|||Mantel Haenszel|The critical level for significance (p\<0.044) was adjusted for two interim analyses, and all tests were conducted using two-sided tests.||Initial sample size of 580 planned to detect clinically meaningful a 12% difference in 30-day mortality (23% vs. 35%),supported by prior data. DSMB increased sample size to 680 according to trial's adaptive design. With 680 patients \& given final observed mortality proportions in the 1:1:1 group, PROPPR had 92% power to detect the pre-specified 12% difference at 30 days, if such differences existed.||1.12|0.65|0.26
72336092|NCT01545232|144195255|SUPERIORITY_OR_OTHER|||||||0.83|TWO_SIDED||||||van Elteren's test for medians|||||||0.83
72336093|NCT01545232|144195256|SUPERIORITY_OR_OTHER|||||||0.44|TWO_SIDED||||||van Elteren's test for medians|||||||0.44
72336094|NCT01545232|144195258|SUPERIORITY_OR_OTHER|||||||0.11|TWO_SIDED||||||van Elteren's test for medians|||||||0.11
72336095|NCT01545232|144195259|SUPERIORITY_OR_OTHER||Risk Difference (RD)|2.8|||||TWO_SIDED|95.0|-2.8|8.3||||||||8.3|-2.8|
72336096|NCT01545232|144195260|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.3|||||TWO_SIDED|95.0|-0.8|1.7||||||||1.7|-0.8|
72336097|NCT01545232|144195261|SUPERIORITY_OR_OTHER|||||||0.37|TWO_SIDED||||||generalized logit model regression|||||||0.37
72336098|NCT01545232|144195262|SUPERIORITY_OR_OTHER|||||||0.14|TWO_SIDED||||||van Elteren's test for medians|||||||0.14
72336099|NCT01545232|144195263|SUPERIORITY_OR_OTHER|||||||0.1|TWO_SIDED||||||van Elteren's test for medians|||||||0.10
72336100|NCT00798317|144195275|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.13|||<|0.001|TWO_SIDED|95.0|1.97|17.0||Comparing placebo and ocriplasmin|Fisher Exact|||||17.00|1.97|<0.001
72336101|NCT00378599|144195278|SUPERIORITY_OR_OTHER||Binomial Approximation|0.288|||||TWO_SIDED|95.0|0.21|0.38||||||||0.38|0.21|
72336102|NCT00489736|144195320|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.59|||<|0.0001||95.0|1.28|1.98||Cumulative incidence functions in each treatment group were calculated using time-to-event non-parametric Kaplan-Meier estimate. The primary comparison was performed at the 5% level using a 2-sided Log rank test.|Log Rank||The hazard ratio was estimated by a Cox's proportional hazard model with treatment arm factor. It provides the relative hazard of treatment failure for the dronedarone group compared with the amiodarone group.|||1.98|1.28|<0.0001
72336103|NCT00489736|144195321|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.8||||0.13||95.0|0.6|1.07||Cumulative incidence functions in each treatment group were calculated using time-to-event non-parametric Kaplan-Meier estimate. The comparison was performed at the 5% level using a 2-sided Log rank test.|Log Rank||The hazard ratio was estimated by a Cox's proportional hazard model with treatment arm factor. It provides the relative hazard of main safety event occurrence for the dronedarone group compared with the amiodarone group.|||1.07|0.60|0.13
72336104|NCT00489736|144195322|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.61||||0.002||95.0|0.44|0.84||Cumulative incidence functions in each treatment group were calculated using time-to-event non-parametric Kaplan-Meier estimate. The comparison was performed at the 5% level using a 2-sided Log rank test.|Log Rank||The hazard ratio was estimated by a Cox's proportional hazard model with treatment arm factor. It provides the relative hazard of MSE occurrence excluding gastrointestinal events, for the dronedarone group compared with the amiodarone group.|||0.84|0.44|0.002
72336105|NCT03920293|144195410|SUPERIORITY||LS Mean Difference|-1.6|STANDARD_ERROR_OF_MEAN|0.49|=|0.0009|TWO_SIDED|95.0|-2.6|-0.7||Statistical significance was tested at α=0.05.|MMRM|||||-0.7|-2.6|=0.0009
72336106|NCT01691885|144195417|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.83|||<|0.001|TWO_SIDED|95.0|2.74|8.91|||ANCOVA|Analysis was performed using an ANCOVA model with covariates of treatment, baseline, period and subject as a random effect.||||8.91|2.74|<0.001
72426692|NCT00924469|144365536|SUPERIORITY_OR_OTHER||Adjusted mean ratio|1.2||||0.7061||90.0|0.53|2.73|||ANCOVA|||Statistical Analysis 12 for serum DHEA-sulfate concentration at Week 24||2.730|0.530|0.7061
72336107|NCT03989427|144195427|EQUIVALENCE|The two treatment sequence could be called equivalent if the observed difference and its 95% CI are completely inside the interval of clinical equivalence. A significant result (p \< 0.05) means that the two treatments are equivalent, according the definition of equivalence as defined clinically.|Mean Difference (Net)|1.424||||0.022|TWO_SIDED|95.0|0.221|2.628||The threshold for statistical significance was p \<0.05|ANOVA|Three-way mixed ANOVA was done to determine the effect of Intervention on BPI scores .||"Null hypothesis is that the sequence of brushing first and flossing later has no effect on gingival inflammation.~No previous studies with Mean and SD were available. Hence, a pilot study was done. 30 participants were randomly assigned to Brush first and floss later (BF) group ; and Floss first brush later(FB) group. After 1 week there was cross-over. 80% power is required to detect mean difference in BPI scores."||2.628|0.221|0.022
72336108|NCT03989427|144195428|EQUIVALENCE|The two treatment sequence could be called equivalent if the observed difference and its 95% CI are completely inside the interval of clinical equivalence. A significant result (p \< 0.05) means that the two treatments are equivalent, according the definition of equivalence as defined clinically.|Mean Difference (Net)|-0.058||||0.971|TWO_SIDED|95.0|-3.335|3.219|||ANOVA|Three-way mixed ANOVA was done to determine the effect of Intervention on RMNPI index scores||"Null hypothesis:~The sequence of brushing and flossing has no effect on plaque scores~There were no previous studies with Mean and SD to calculate sample. So a pilot study was conducted. 30 participants were randomly assigned in 1:1 fashion to Brush-floss (GroupA) and Floss brush group (group B). Then after 1 week there was cross-over among the groups.2 groups would have at least 80% power to detect the mean difference in BPI scores."||3.219|-3.335|0.971
72336109|NCT03272828|144195429|SUPERIORITY|||||||0.63|||||||Fisher Exact|||||||0.63
72336110|NCT03272828|144195430|SUPERIORITY|||||||0.06|||||||Unequal-variance 2-sample t-test|||||||0.06
72336111|NCT03272828|144195431|SUPERIORITY|||||||0.45|||||||Unequal-variance 2-sample t-test|||||||0.45
72426693|NCT00924469|144365536|SUPERIORITY_OR_OTHER||Adjusted mean ratio|0.42|||<|0.0001||90.0|0.29|0.615||Test for no difference of natural log transformed values between treatments was calculated using ANCOVA adjusting for Baseline risk factor and Baseline androgen.|ANCOVA|||Statistical Analysis 13 for serum delta-4-androstenedione concentration at Week 12||0.615|0.290|<0.0001
72426694|NCT00924469|144365536|SUPERIORITY_OR_OTHER||Adjusted mean ratio|1.22||||0.2673||90.0|0.916|1.625||Test for no difference of natural log transformed values between treatments was calculated using ANCOVA adjusting for Baseline risk factor and Baseline androgen.|ANCOVA|||Statistical Analysis 14 for serum delta-4-androstenedione concentration at Week 24||1.625|0.916|0.2673
72426695|NCT00924469|144365537|SUPERIORITY_OR_OTHER||Relative risk|25.533|||<|0.0001||90.0|4.989|130.68|||Cochran-Mantel-Haenszel|||Statistical Analysis 1 for PSA response at Week 12||130.680|4.989|<0.0001
72426696|NCT00924469|144365537|SUPERIORITY_OR_OTHER||Relative risk|1.131||||0.2319||90.0|0.956|1.337|||Cochran-Mantel-Haenszel|||Statistical Analysis 2 for PSA response at Week 24||1.337|0.956|0.2319
72426697|NCT00924469|144365538|SUPERIORITY_OR_OTHER||Relative risk|2.744||||0.3427||90.0|1.018|5.015|||Cochran-Mantel-Haenszel|||Statistical Analysis 1 for CR at Week 24||5.015|1.018|0.3427
72426698|NCT00924469|144365541|SUPERIORITY_OR_OTHER||Adjusted mean ratio|0.17|||<|0.0001||90.0|0.098|0.289||Test for no difference of natural log transformed values between treatments was calculated using two-way ANOVA adjusting for Baseline risk factor.|ANOVA|||Statistical Analysis 2 for DHT concentration at Week 12||0.289|0.098|<0.0001
72426699|NCT01651936|144365548|SUPERIORITY_OR_OTHER_LEGACY||Difference in least squares means|-0.52||||0.308|TWO_SIDED|95.0|-1.54|0.5|||Constrained Longitudinal Data Analysis|||||0.50|-1.54|0.308
72426700|NCT01651936|144365549|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentages|-0.26||||0.91|TWO_SIDED|95.0|-23.52|23.01|||Cochran-Mantel-Haenszel|||||23.01|-23.52|0.91
72426701|NCT01651936|144365551|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentages|8.46||||0.468|TWO_SIDED|95.0|-10.4|27.32|||Cochran-Mantel-Haenszel|||||27.32|-10.40|0.468
72426702|NCT01651936|144365553|SUPERIORITY_OR_OTHER_LEGACY||Difference in least squares means|-0.41||||0.038|TWO_SIDED|95.0|-0.79|-0.02|||Constrained Longitudinal Data Analysis|||||-0.02|-0.79|0.038
72426703|NCT03745794|144365633|OTHER|||||||0.17|||||||Chi-squared|||||||0.17
72426704|NCT00981825|144365646|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
72426705|NCT02743793|144365647|OTHER|No test was performed.|Kaplan-Meier survival estimate|64.0|||||TWO_SIDED|95.0|21.3|87.9|||||Percent of participants that remained tolerant during study participation.|||87.9|21.3|
72426706|NCT01461993|144365656|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority criteria margin was 1.5-fold.|GMT Ratio|0.82||||||95.0|0.72|0.94||||||HPV-6||0.94|0.72|
72426707|NCT01461993|144365656|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority criteria margin was 1.5-fold.|GMT Ratio|0.82|||||TWO_SIDED|95.0|0.74|0.91||||||HPV-11||0.91|0.74|
72426708|NCT01461993|144365656|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority criteria margin was 1.5-fold.|GMT Ratio|0.78|||||TWO_SIDED|95.0|0.68|0.88||||||HPV-16||0.88|0.68|
72426709|NCT01461993|144365656|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority criteria margin was 1.5-fold.|GMT Ratio|0.71|||||TWO_SIDED|95.0|0.62|0.81||||||HPV-18||0.81|0.62|
72426710|NCT01461993|144365657|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority criteria margin was 1.5-fold.|GMT Ratio|0.92|||||TWO_SIDED|95.0|0.85|1.0||||||PMB80 \[A22\]||1.00|0.85|
72426711|NCT01461993|144365657|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority criteria margin was 1.5-fold.|GMT Ratio|0.92|||||TWO_SIDED|95.0|0.84|1.01||||||PMB2948 \[B24\]||1.01|0.84|
72426712|NCT01088529|144365683|SUPERIORITY_OR_OTHER||Relative risk|1.432||||0.2148|TWO_SIDED|90.0|0.859|2.386|||Chi-squared|||||2.386|0.859|0.2148
72426713|NCT01088529|144365684|SUPERIORITY_OR_OTHER||Relative risk|0.477||||0.1796|TWO_SIDED|90.0|0.205|1.109|||Fisher Exact|||||1.109|0.205|0.1796
72426714|NCT01088529|144365685|SUPERIORITY_OR_OTHER||Relative risk|6.523|||<|0.0001|TWO_SIDED|90.0|2.701|15.753|||Chi-squared|||||15.753|2.701|<0.0001
72426715|NCT02341144|144365703|SUPERIORITY|||||||0.11|||||||Wilcoxon (Mann-Whitney)|||||||0.11
72426716|NCT02341144|144365704|SUPERIORITY|||||||0.08|||||||Wilcoxon (Mann-Whitney)|||||||0.08
72426717|NCT02341144|144365705|SUPERIORITY|||||||0.39|||||||Chi-squared|||||||0.39
72426718|NCT02341144|144365706|SUPERIORITY|||||||0.11|||||||Wilcoxon (Mann-Whitney)|||||||0.11
72426719|NCT02341144|144365707|SUPERIORITY|||||||0.44|||||||Wilcoxon (Mann-Whitney)|||||||0.44
72426720|NCT00383240|144365756|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||P-Value for Endpoint|ANCOVA|||||||<.001
72426721|NCT00383240|144365756|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||P-Value for Endpoint|ANCOVA|||||||<.001
72426722|NCT00383240|144365756|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||P-Value for Endpoint|ANCOVA|||||||<.001
72426723|NCT00383240|144365756|SUPERIORITY_OR_OTHER_LEGACY|||||||0.491||95.0||||P-Value for Endpoint|ANCOVA|||||||0.491
72426724|NCT00383240|144365756|SUPERIORITY_OR_OTHER_LEGACY|||||||0.055||95.0||||P-Value for Endpoint|ANCOVA|||||||0.055
72426725|NCT00383240|144365756|SUPERIORITY_OR_OTHER_LEGACY|||||||0.008||95.0||||P-Value for Endpoint|ANCOVA|||||||0.008
72426726|NCT00383240|144365757|SUPERIORITY_OR_OTHER_LEGACY|||||||0.174||95.0||||P-Value for Endpoint|ANCOVA|||||||0.174
72426727|NCT00383240|144365757|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||P-Value for Endpoint|ANCOVA|||||||<.001
72426728|NCT00383240|144365757|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||P-Value for Endpoint|ANCOVA|||||||<.001
72426729|NCT00383240|144365757|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||P-Value for Endpoint|ANCOVA|||||||<.001
72426730|NCT00383240|144365757|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||P-Value for Endpoint|ANCOVA|||||||<.001
72426731|NCT00383240|144365757|SUPERIORITY_OR_OTHER_LEGACY|||||||0.521||95.0||||P-Value for Endpoint|ANCOVA|||||||0.521
72426732|NCT00383240|144365759|SUPERIORITY_OR_OTHER_LEGACY|||||||0.026||95.0||||P-Value for Endpoint|ANCOVA|||||||0.026
72426733|NCT00383240|144365759|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||P-Value for Endpoint|ANCOVA|||||||<.001
72426734|NCT00383240|144365759|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||P-Value for Endpoint|ANCOVA|||||||<.001
72426735|NCT00383240|144365759|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||P-Value for Endpoint|ANCOVA|||||||<.001
72426736|NCT00383240|144365759|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||P-Value for Endpoint|ANCOVA|||||||<.001
72426737|NCT00383240|144365759|SUPERIORITY_OR_OTHER_LEGACY|||||||0.738||95.0||||P-Value for Endpoint|ANCOVA|||||||0.738
72426738|NCT00383240|144365760|SUPERIORITY_OR_OTHER_LEGACY|||||||0.063||95.0||||P-Value for endpoint|ANCOVA|||||||0.063
72426739|NCT00383240|144365760|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||P-Value for Endpoint|ANCOVA|||||||<.001
72426740|NCT00383240|144365760|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||P-Value for Endpoint|ANCOVA|||||||<.001
72426741|NCT00383240|144365760|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||P-Value for Endpoint|ANCOVA|||||||<.001
72426742|NCT00383240|144365760|SUPERIORITY_OR_OTHER_LEGACY|||||||0.003||95.0||||P-Value for Endpoint|ANCOVA|||||||0.003
72426743|NCT00383240|144365760|SUPERIORITY_OR_OTHER_LEGACY|||||||0.601||95.0||||P-Value for Endpoint|ANCOVA|||||||0.601
72426744|NCT02023879|144365763|SUPERIORITY_OR_OTHER||Least square (LS) mean difference|-56.4|||<|0.0001|TWO_SIDED|95.0|-62.9|-49.9||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab 150 mg Q4W/Up to 150 mg Q2W vs. Placebo|Alirocumab 150 mg Q4W/up to 150 mg Q2W was compared to placebo group using an appropriate contrast statement.||-49.9|-62.9|<0.0001
72426745|NCT02023879|144365764|SUPERIORITY_OR_OTHER||LS Mean Difference|-59.7|||<|0.0001|TWO_SIDED|95.0|-65.6|-53.8||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab 150 mg Q4W/Up to 150 mg Q2W vs. Placebo|A hierarchical testing procedure was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when previous endpoint was statistically significant at 0.05 level.||-53.8|-65.6|<0.0001
72426746|NCT02023879|144365765|SUPERIORITY_OR_OTHER||LS Mean Difference|-44.9|||<|0.0001|TWO_SIDED|95.0|-51.8|-38.1||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab 150 mg Q4W/Up to 150 mg Q2W vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-38.1|-51.8|<0.0001
72426747|NCT02023879|144365766|SUPERIORITY_OR_OTHER||LS Mean Difference|-48.4|||<|0.0001|TWO_SIDED|95.0|-54.8|-41.9||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab 150 mg Q4W/Up to 150 mg Q2W vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-41.9|-54.8|<0.0001
72426748|NCT02023879|144365767|SUPERIORITY_OR_OTHER||LS Mean Difference|-55.5|||<|0.0001|TWO_SIDED|95.0|-61.1|-49.8||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab 150 mg Q4W/Up to 150 mg Q2W vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-49.8|-61.1|<0.0001
72426749|NCT02023879|144365768|SUPERIORITY_OR_OTHER||LS Mean Difference|-58.6|||<|0.0001|TWO_SIDED|95.0|-63.8|-53.4||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab 150 mg Q4W/Up to 150 mg Q2W vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-53.4|-63.8|<0.0001
72426750|NCT02023879|144365769|SUPERIORITY_OR_OTHER||LS Mean Difference|-46.4|||<|0.0001|TWO_SIDED|95.0|-52.4|-40.4||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab 150 mg Q4W/Up to 150 mg Q2W vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-40.4|-52.4|<0.0001
72426751|NCT02023879|144365770|SUPERIORITY_OR_OTHER||LS Mean Difference|-48.6|||<|0.0001|TWO_SIDED|95.0|-54.3|-42.8||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab 150 mg Q4W/Up to 150 mg Q2W vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-42.8|-54.3|<0.0001
72426752|NCT02023879|144365771|SUPERIORITY_OR_OTHER||LS Mean Difference|-49.0|||<|0.0001|TWO_SIDED|95.0|-54.9|-43.2||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab 150 mg Q4W/Up to 150 mg Q2W vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-43.2|-54.9|<0.0001
72426753|NCT02023879|144365772|SUPERIORITY_OR_OTHER||LS Mean Difference|-51.7|||<|0.0001|TWO_SIDED|95.0|-57.1|-46.4||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab 150 mg Q4W/Up to 150 mg Q2W vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-46.4|-57.1|<0.0001
72426754|NCT02023879|144365773|SUPERIORITY_OR_OTHER||LS Mean Difference|-35.3|||<|0.0001|TWO_SIDED|95.0|-39.8|-30.8||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab 150 mg Q4W/Up to 150 mg Q2W vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-30.8|-39.8|<0.0001
72426755|NCT02023879|144365774|SUPERIORITY_OR_OTHER||LS Mean Difference|-38.2|||<|0.0001|TWO_SIDED|95.0|-44.3|-32.1||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab 150 mg Q4W/Up to 150 mg Q2W vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-32.1|-44.3|<0.0001
72426756|NCT02023879|144365775|SUPERIORITY_OR_OTHER||LS Mean Difference|-37.9|||<|0.0001|TWO_SIDED|95.0|-43.9|-31.8||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab 150 mg Q4W/Up to 150 mg Q2W vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-31.8|-43.9|<0.0001
72426757|NCT02023879|144365776|SUPERIORITY_OR_OTHER||LS Mean Difference|-26.3|||<|0.0001|TWO_SIDED|95.0|-30.9|-21.7||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab 150 mg Q4W/Up to 150 mg Q2W vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-21.7|-30.9|<0.0001
72426758|NCT02023879|144365777|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|279.8|||<|0.0001|TWO_SIDED|95.0|29.1|2690.1||Threshold for significance at 0.05 level.|Regression, Logistic|Multiple imputation approach followed by logistic regression model.|Alirocumab 150 mg Q4W/Up to 150 mg Q2W vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||2690.1|29.1|<0.0001
72426759|NCT02023879|144365778|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|354.7|||<|0.0001|TWO_SIDED|95.0|36.2|3479.5||Threshold for significance at 0.05 level.|Regression, Logistic|Multiple imputation approach followed by logistic regression model.|Alirocumab 150 mg Q4W/Up to 150 mg Q2W vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||3479.5|36.2|<0.0001
72426760|NCT02023879|144365779|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|126.0|||<|0.0001|TWO_SIDED|95.0|20.0|9999.0||Threshold for significance at 0.05 level.|Regression, Logistic|LOCF approach followed by logistic regression model.|Alirocumab 150 mg Q4W/Up to 150 mg Q2W vs. Placebo (Confidence interval should be read as 20.0 to \>9999)|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||9999|20.0|<0.0001
72426761|NCT02023879|144365780|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|141.5|||<|0.0001|TWO_SIDED|95.0|22.2|9999.0||Threshold for significance at 0.05 level.|Regression, Logistic|LOCF approach followed by logistic regression model.|Alirocumab 150 mg Q4W/Up to 150 mg Q2W vs. Placebo (Confidence interval should be read as 20.0 to \>9999)|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||9999|22.2|<0.0001
72426762|NCT02023879|144365781|SUPERIORITY_OR_OTHER||Adjusted mean difference|-19.6||||0.0002|TWO_SIDED|95.0|-29.8|-9.4||Threshold for significance at 0.05 level.|Regression, Robust|Multiple imputation approach followed by robust regression model.|Alirocumab 150 mg Q4W/Up to 150 mg Q2W vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-9.4|-29.8|0.0002
72426763|NCT02023879|144365782|SUPERIORITY_OR_OTHER||Adjusted mean difference|-7.9||||0.0892|TWO_SIDED|95.0|-17.1|1.2||Threshold for significance at 0.05 level.|Regression, Robust|Multiple imputation approach followed by robust regression model.|Alirocumab 150 mg Q4W/Up to 150 mg Q2W vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||1.2|-17.1|0.0892
72426764|NCT03918239|144365839|OTHER|Analysis was performed for estimation of least square means only. Descriptive statistical analysis was the main analysis.|Ratio of Geometric least squares Means|1.079|||||TWO_SIDED|90.0|0.986|1.181|||ANOVA|||An analysis of variance was performed with the natural log-transformed PK parameters as the dependent variable and treatment group as a fixed effect variable.||1.181|0.986|
72426765|NCT03918239|144365840|OTHER|Analysis was performed for estimation of least square means only. Descriptive statistical analysis was the main analysis.|Ratio of Geometric least squares Means|1.079|||||TWO_SIDED|90.0|0.987|1.179||||||An analysis of variance was performed with the natural log-transformed PK parameters as the dependent variable and treatment group as a fixed effect variable.||1.179|0.987|
72336112|NCT03777709|144195434|SUPERIORITY||Mean Difference (Final Values)|1.45|STANDARD_DEVIATION|2.0|<|0.0001|TWO_SIDED|||||unadjusted p-value|Regression, Linear||A recruitment aim of 40 participants per church (16 churches, 8 per arm, mean of 5 participants per church) provides 80% power to detect a difference of 1.45 in mean LS7 score change between groups (effect size 0.73).|Effect size of 1-unit difference in mean LS7 score was based on meta-analysis indicating each unit increase in mean LS7 metrics equates to a 19% and 11% reduction in CVD and all-cause mortality, respectively. Power calculations to estimate sample size: church goal of 16 churches (8/arm), with mean 5 participants/church (40/arm) to provide 80% power to detect 1.45 difference in average LS7 score change between groups (.01 intracluster correlation, and .5 coefficient of variation of church sizes).||||<0.0001
72336113|NCT03552536|144195486|SUPERIORITY|Adjusted by Placebo data pooled from historical placebo data from recent monotherapy studies in HIV-1 infected participants (NCT00100048, NCT01466985, NCT01152255, and NCT01353898) and fitted with a longitudinal data analysis (LDA) model containing fixed effects for study and time, and a random effect for participants. Least squares (LS) mean (95% confidence interval) for change from baseline at 168 hours post dose of pooled historical placebo was -0.03 log10 copies/mL (-0.14, 0.09).|Posterior Mean Difference|-0.6|||||||||||||Posterior Probability (PP) of true mean difference in the plasma HIV-1 RNA change from baseline between MK-8583 and placebo at least 0.5 log10 copies/mL was 64%.|||||
72336114|NCT03061721|144195510|SUPERIORITY|||||||0.0002|||||||ANCOVA|||||||0.0002
72336115|NCT03061721|144195510|SUPERIORITY|||||||0.0001|||||||ANCOVA|||||||0.0001
72336116|NCT03061721|144195510|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
72336117|NCT03061721|144195511|SUPERIORITY|||||||0.5681|||||||ANCOVA|||||||0.5681
72336118|NCT03061721|144195511|SUPERIORITY|||||||0.4487|||||||ANCOVA|||||||0.4487
72336119|NCT03061721|144195511|SUPERIORITY|||||||0.0021|||||||ANCOVA|||||||0.0021
72336120|NCT03061721|144195512|SUPERIORITY|||||||0.007|||||||Chi-squared|||||||0.0070
72336121|NCT03061721|144195512|SUPERIORITY|||||||0.0031|||||||Chi-squared|||||||0.0031
72336122|NCT03061721|144195512|SUPERIORITY|||||||0.0001|||||||Chi-squared|||||||0.0001
72336123|NCT03061721|144195513|SUPERIORITY|||||||0.2241|||||||ANCOVA|||||||0.2241
72336124|NCT03061721|144195513|SUPERIORITY|||||||0.0304|||||||ANCOVA|||||||0.0304
72336125|NCT03061721|144195513|SUPERIORITY|||||||0.0595|||||||ANCOVA|||||||0.0595
72336126|NCT03061721|144195514|SUPERIORITY|||||||0.0449|||||||ANCOVA|||||||0.0449
72336127|NCT03061721|144195514|SUPERIORITY|||||||0.0053|||||||ANCOVA|||||||0.0053
72336128|NCT03061721|144195514|SUPERIORITY|||||||0.0036|||||||ANCOVA|||||||0.0036
72336129|NCT03061721|144195515|SUPERIORITY|||||||0.0045|||||||ANCOVA|||||||0.0045
72336130|NCT03061721|144195515|SUPERIORITY|||||||0.0026|||||||ANCOVA|||||||0.0026
72336131|NCT03061721|144195515|SUPERIORITY|||||||0.0004|||||||ANCOVA|||||||0.0004
72336132|NCT03061721|144195524|SUPERIORITY|||||||0.2387|||||||ANCOVA|||||||0.2387
72336133|NCT03061721|144195524|SUPERIORITY|||||||0.1496|||||||ANCOVA|||||||0.1496
72336134|NCT03061721|144195524|SUPERIORITY|||||||0.0445|||||||ANCOVA|||||||0.0445
72336135|NCT06276881|144195530|SUPERIORITY|||||||0.37|||||||t-test, 1 sided||||Multiple regression analysis|||.37
72336136|NCT06276881|144195531|SUPERIORITY|||||||0.07|||||||ANOVA|||||||.07
72336137|NCT03664674|144195532|SUPERIORITY||Mean Difference (Net)|-0.221|STANDARD_ERROR_OF_MEAN|0.218||0.312|TWO_SIDED|95.0|-0.648|0.207||Generalized Linear Model - Negative Binomial Regression Model with count data by subject transformed using the log-link function.|Regression, Linear|The parameter estimate + conf. int. results back-transform to the ratio of adjusted mean DVDs (OTO-104/Placebo) to be 0.802 (0.523, 1.230).||||0.207|-0.648|0.312
72336138|NCT02780856|144195582|SUPERIORITY||||||<|0.0001|||||||exact binomial|An exact binomial test was used and an exact 97.5% Confidence Level using the Clopper-Pearson method was calculated||The null and alternative hypothesis for each tooth population was of chance agreement (50%) and was tested against an exact binomial one-sided 97.5% confidence interval||||<0.0001
72336139|NCT02780856|144195582|SUPERIORITY||||||<|0.0001|||||||exact binomial|An exact binomial test was used and an exact 97.5% Confidence Level using the Clopper-Pearson method was calculated||The null and alternative hypothesis for each tooth population was of chance agreement (50%) and was tested against an exact binomial one-sided 97.5% confidence interval||||<0.0001
72336140|NCT03172884|144195589|OTHER||LS means|1.385|||||TWO_SIDED|90.0|0.921|2.081||||||Moderate Hepatic Impairment vs Healthy Subjects||2.081|0.921|
72336141|NCT03172884|144195589|OTHER||LS means|1.445|||||TWO_SIDED|90.0|0.998|2.093||||||Severe hepatic impairment group vs Healthy Subjects||2.093|0.998|
72336142|NCT03172884|144195589|OTHER||LS means|0.646|||||TWO_SIDED|90.0|0.486|0.858||||||Severe renal impairment group vs Healthy Subjects||0.858|0.486|
72336143|NCT03172884|144195590|OTHER||LS Means|1.711|||||TWO_SIDED|90.0|1.148|2.55||||||Moderate Hepatic Impairment group vs Healthy Subjects||2.550|1.148|
72336144|NCT03172884|144195590|OTHER||LS Means|2.705|||||TWO_SIDED|90.0|2.115|3.46||||||Severe hepatic impairment group vs Healthy Subjects||3.460|2.115|
72336145|NCT03172884|144195590|OTHER||LS Means|1.075|||||TWO_SIDED|90.0|0.696|1.659||||||Severe renal impairment group vs Healthy Subjects||1.659|0.696|
72336146|NCT03172884|144195591|OTHER||LS Means|1.768|||||TWO_SIDED|90.0|1.251|2.498||||||Moderate Hepatic Impairment group vs Healthy Subjects||2.498|1.251|
72336147|NCT03172884|144195591|OTHER||LS Means|2.735|||||TWO_SIDED|90.0|2.163|3.459||||||Severe hepatic impairment group vs Healthy Subjects||3.459|2.163|
72336148|NCT03172884|144195591|OTHER||LS Means|1.124|||||TWO_SIDED|90.0|0.815|1.549||||||Severe renal impairment group vs Healthy Subjects||1.549|0.815|
72336149|NCT00457821|144195599|SUPERIORITY_OR_OTHER||||||<|0.05||95.0||||There was no adjustment for multiple comparisons.|Mixed Models Analysis|||Within-dose group and between-dose group analyses were performed, using a linear mixed effect model with baseline, dose, and period as fixed effects and subject as a random effect.||||<0.05
72336150|NCT00457821|144195600|SUPERIORITY_OR_OTHER||||||<|0.05||95.0||||There was no adjustment for multiple comparisons.|Mixed Models Analysis|||Within-dose group and between-dose group analyses were performed, using a linear mixed effect model with baseline, dose, and period as fixed effects and subject as a random effect.||||<0.05
72426766|NCT03918239|144365841|OTHER|Analysis was performed for estimation of least square means only. Descriptive statistical analysis was the main analysis.|Ratio of Geometric least squares Means|1.157|||||TWO_SIDED|90.0|1.044|1.281||||||An analysis of variance was performed with the natural log-transformed PK parameters as the dependent variable and treatment group as a fixed effect variable.||1.281|1.044|
72426767|NCT01987596|144365879|SUPERIORITY|||||||1|||||||McNemar|||||||1.00
72426768|NCT01987596|144365880|SUPERIORITY||||||<|0.0001|||||||ANOVA|||two-period crossover design analysis||||<0.0001
72426769|NCT01987596|144365881|SUPERIORITY||||||<|0.0001|||||||ANOVA|||2 treatment, 2 periiod cross-over analysis||||<0.0001
72426770|NCT00179010|144365914|SUPERIORITY_OR_OTHER|||||||0.854|||||||ANOVA|||||||0.854
72426771|NCT00919893|144365940|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05|||||||t-test, 2 sided|||"Null hypothesis: Cernilton compared to placebo induces a better or the same outcome of symptomatic improvement in the pain domain of symptomatic Pelvic Pain Syndrome verified by the National Institutes of Health-Chronic Prostatitis Symptom Index (NIH-CPSI).~Power calculation: A power of 1-beta=0.8 was calculated."||||<0.05
72426772|NCT00453479|144365944|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.97|STANDARD_ERROR_OF_MEAN|5.596|||TWO_SIDED|95.0|-12.68|10.75|||||Comparison of SBP Day 1.|||10.75|-12.68|
72426773|NCT00453479|144365944|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.1|STANDARD_ERROR_OF_MEAN|4.215|||TWO_SIDED|95.0|-12.92|4.72|||||Comparison of SBP Day 7.|||4.72|-12.92|
72426774|NCT00453479|144365944|SUPERIORITY_OR_OTHER||Mean Difference (Net)|6.21|STANDARD_ERROR_OF_MEAN|5.727|||TWO_SIDED|95.0|-5.78|18.19|||||Comparison of SBP Day 1.|||18.19|-5.78|
72426775|NCT00453479|144365944|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.76|STANDARD_ERROR_OF_MEAN|4.314|||TWO_SIDED|95.0|-13.79|4.27|||||Comparison of SBP Day 7.|||4.27|-13.79|
72426776|NCT00453479|144365944|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.58|STANDARD_ERROR_OF_MEAN|2.138|||TWO_SIDED|95.0|-3.89|5.06|||||Comparison of DBP Day 1.|||5.06|-3.89|
72426777|NCT00453479|144365944|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-6.64|STANDARD_ERROR_OF_MEAN|2.382|||TWO_SIDED|95.0|-11.62|-1.65|||||Comparison of DBP Day 7.|||-1.65|-11.62|
72426778|NCT00453479|144365944|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.98|STANDARD_ERROR_OF_MEAN|2.248|||TWO_SIDED|95.0|-3.73|5.68|||||Comparison of DBP Day 1.|||5.68|-3.73|
72426779|NCT00453479|144365944|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-10.81|STANDARD_ERROR_OF_MEAN|2.504|||TWO_SIDED|95.0|-16.05|-5.57|||||Comparison of DBP Day 7.|||-5.57|-16.05|
72426780|NCT00453479|144365945|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.26|STANDARD_ERROR_OF_MEAN|3.745|||TWO_SIDED|95.0|-5.58|10.1|||||Comparison at Day 1.|||10.10|-5.58|
72336151|NCT00457821|144195602|SUPERIORITY_OR_OTHER||||||<|0.05||95.0||||There was no adjustment for multiple comparisons.|Mixed Models Analysis|||Within-dose group and between-dose group analyses were performed, using a linear mixed effect model with baseline, dose, and period as fixed effects and subject as a random effect.||||<0.05
72426781|NCT00453479|144365945|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.62|STANDARD_ERROR_OF_MEAN|3.785|||TWO_SIDED|95.0|-5.3|10.54|||||Comparison at Day 7.|||10.54|-5.30|
72426782|NCT00453479|144365945|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.16|STANDARD_ERROR_OF_MEAN|3.979|||TWO_SIDED|95.0|-8.17|8.48|||||Comparison at Day 1.|||8.48|-8.17|
72426783|NCT00453479|144365945|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.44|STANDARD_ERROR_OF_MEAN|4.021|||TWO_SIDED|95.0|-13.86|2.97|||||Comparison at Day 7.|||2.97|-13.86|
72426784|NCT00453479|144365946|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.78|STANDARD_ERROR_OF_MEAN|4.611|||TWO_SIDED|95.0|-12.43|6.87|||||Comparison of SBP Day 1.|||6.87|-12.43|
72426785|NCT00453479|144365946|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.88|STANDARD_ERROR_OF_MEAN|3.913|||TWO_SIDED|95.0|-10.07|6.31|||||Comparison of SBP Day 7.|||6.31|-10.07|
72426786|NCT00453479|144365946|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.01|STANDARD_ERROR_OF_MEAN|4.718|||TWO_SIDED|95.0|-6.87|12.88|||||Comparison of SBP Day 1.|||12.88|-6.87|
72426787|NCT00453479|144365946|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.5|STANDARD_ERROR_OF_MEAN|4.005|||TWO_SIDED|95.0|-11.88|4.89|||||Comparison of SBP Day 7.|||4.89|-11.88|
72426788|NCT00453479|144365946|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.28|STANDARD_ERROR_OF_MEAN|1.822|||TWO_SIDED|95.0|-4.09|3.54|||||Comparison of DBP Day 1.|||3.54|-4.09|
72426789|NCT00453479|144365946|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.89|STANDARD_ERROR_OF_MEAN|2.116|||TWO_SIDED|95.0|-8.32|0.54|||||Comparison of DBP Day 7.|||0.54|-8.32|
72426790|NCT00453479|144365946|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.75|STANDARD_ERROR_OF_MEAN|1.916|||TWO_SIDED|95.0|-5.76|2.26|||||Comparison of DBP Day 1.|||2.26|-5.76|
72426791|NCT00453479|144365946|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-9.39|STANDARD_ERROR_OF_MEAN|2.224|||TWO_SIDED|95.0|-14.04|-4.73|||||Comparison of DBP Day 7.|||-4.73|-14.04|
72426792|NCT00453479|144365947|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.14|STANDARD_ERROR_OF_MEAN|2.7|||TWO_SIDED|95.0|-5.52|5.79|||||Comparison at Day 1.|||5.79|-5.52|
72426793|NCT00453479|144365947|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.39|STANDARD_ERROR_OF_MEAN|2.813|||TWO_SIDED|95.0|-3.5|8.28|||||Comparison at Day 7.|||8.28|-3.50|
72426794|NCT00453479|144365947|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.67|STANDARD_ERROR_OF_MEAN|2.869|||TWO_SIDED|95.0|-8.67|3.34|||||Comparison at Day 1.|||3.34|-8.67|
72426795|NCT00453479|144365947|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.84|STANDARD_ERROR_OF_MEAN|2.989|||TWO_SIDED|95.0|-10.1|2.41|||||Comparison at Day 7.|||2.41|-10.10|
72426796|NCT00453479|144365949|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.42|STANDARD_ERROR_OF_MEAN|8.157|||TWO_SIDED|95.0|-12.66|21.49|||||Comparison of QTcB Day 1.|||21.49|-12.66|
72426797|NCT00453479|144365949|SUPERIORITY_OR_OTHER||Mean Difference (Net)|9.02|STANDARD_ERROR_OF_MEAN|6.76|||TWO_SIDED|95.0|-5.13|23.17|||||Comparison of QTcB Day 7.|||23.17|-5.13|
72426798|NCT00453479|144365949|SUPERIORITY_OR_OTHER||Mean Difference (Net)|10.57|STANDARD_ERROR_OF_MEAN|8.51|||TWO_SIDED|95.0|-7.24|28.38|||||Comparison of QTcB Day 1.|||28.38|-7.24|
72426799|NCT00453479|144365949|SUPERIORITY_OR_OTHER||Mean Difference (Net)|16.5|STANDARD_ERROR_OF_MEAN|7.052|||TWO_SIDED|95.0|1.74|31.26|||||Comparison of QTcB Day 7.|||31.26|1.74|
72426800|NCT00453479|144365949|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.13|STANDARD_ERROR_OF_MEAN|8.908|||TWO_SIDED|95.0|-16.51|20.78|||||Comparison of QTcF Day 1.|||20.78|-16.51|
72426801|NCT00453479|144365949|SUPERIORITY_OR_OTHER||Mean Difference (Net)|12.29|STANDARD_ERROR_OF_MEAN|5.298|||TWO_SIDED|95.0|1.2|23.38|||||Comparison of QTcF Day 7.|||23.38|1.20|
72426802|NCT00453479|144365949|SUPERIORITY_OR_OTHER||Mean Difference (Net)|17.66|STANDARD_ERROR_OF_MEAN|9.171|||TWO_SIDED|95.0|-1.53|36.85|||||Comparison of QTcF Day 1.|||36.85|-1.53|
72336152|NCT01632241|144195615|SUPERIORITY||Odds Ratio (OR)|1.4||||0.1068|TWO_SIDED|95.0|0.93|2.11|||Regression, Logistic|||||2.11|0.93|0.1068
72336153|NCT01632241|144195624|SUPERIORITY||Odds Ratio (OR)|1.42||||0.0937|TWO_SIDED|95.0|0.94|2.15||Nominal p-value due to step-down sequential testing procedure.|Regression, Logistic|||||2.15|0.94|0.0937
72336154|NCT01632241|144195626|SUPERIORITY||Hazard Ratio (HR)|0.77||||0.2264|TWO_SIDED|95.0|0.51|1.17||Nominal p-value due to step-down sequential testing procedure.|Cox proportional hazards model|||||1.17|0.51|0.2264
72336155|NCT01632241|144195628|SUPERIORITY||Odds Ratio (OR)|1.3||||0.4996|TWO_SIDED|95.0|0.61|2.8||Nominal p-value due to step-down sequential testing procedure.|Regression, Logistic|||||2.80|0.61|0.4996
72336156|NCT05032690|144195667|EQUIVALENCE|The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. The ratio of adjusted geometric means and 90% confidence interval were expressed as percentages.|ratio of adjusted geometric means|99.17|||||TWO_SIDED|90.0|93.72|104.93|||Mixed Models Analysis|||"For comparison of Bosutinib 4\*25 mg Capsule Fed vs. Bosutinib 1\*100 mg Capsule Fed, the model is a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.~The reference treatment of Bosutinib 4\*25 mg Capsule Fed is Bosutinib 1\*100 mg Capsule Fed."||104.93|93.72|
72336157|NCT05032690|144195667|EQUIVALENCE|The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. The ratio of adjusted geometric means and 90% confidence interval were expressed as percentages.|ratio of adjusted geometric means|135.9|||||TWO_SIDED|90.0|109.28|169.01|||Mixed Models Analysis|||"For comparison of Bosutinib 1\*100 mg Capsule Fed vs. Bosutinib 1\*100 mg Capsule Fasted, the model is a mixed effect model with sequence and treatment as fixed effects and participant within sequence as a random effect.~The reference treatment of Bosutinib 1\*100 mg Capsule Fed is Bosutinib 1\*100 mg Capsule Fasted."||169.01|109.28|
72369575|NCT00756613|144249585|EQUIVALENCE|We considered a 20% reduction in primary events to be a reasonable goal of intensive glycemic control over the anticipated 15-year study time period. This effect size was chosen by taking into consideration both the probability of observing an effect of that size given the level of achieved A1c separation, and the perceived value to the patient of this level of benefit relative to the risk and burden of intensive glycemic control.|Cox Proportional Hazard|0.91||||0.24|TWO_SIDED|95.0|0.78|1.06|||Regression, Cox|||To determine the long term effects of intensive glycemic control in type 2 diabetes on major cardiovascular events.||1.06|0.78|0.24
72336158|NCT05032690|144195668|EQUIVALENCE|The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. The ratio of adjusted geometric means and 90% confidence interval were expressed as percentages.|ratio of adjusted geometric means|93.77|||||TWO_SIDED|90.0|90.08|97.61|||Mixed Models Analysis|||"For comparison of Bosutinib 4\*25 mg Capsule Fed vs. Bosutinib 1\*100 mg Capsule Fed, the model is a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.~The reference treatment of Bosutinib 4\*25 mg Capsule Fed is Bosutinib 1\*100 mg Capsule Fed."||97.61|90.08|
72336159|NCT05032690|144195668|EQUIVALENCE|The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. The ratio of adjusted geometric means and 90% confidence interval were expressed as percentages.|ratio of adjusted geometric means|162.54|||||TWO_SIDED|90.0|130.25|202.84|||Mixed Models Analysis|||"For comparison of Bosutinib 1\*100 mg Capsule Fed vs. Bosutinib 1\*100 mg Capsule Fasted, the model is a mixed effect model with sequence and treatment as fixed effects and participant within sequence as a random effect.~The reference treatment of Bosutinib 1\*100 mg Capsule Fed is Bosutinib 1\*100 mg Capsule Fasted"||202.84|130.25|
72426803|NCT00453479|144365949|SUPERIORITY_OR_OTHER||Mean Difference (Net)|22.32|STANDARD_ERROR_OF_MEAN|5.454|||TWO_SIDED|95.0|10.9|33.73|||||Comparison of QTcF Day 7.|||33.73|10.90|
72426804|NCT00453479|144365950|SUPERIORITY_OR_OTHER||Mean Difference (Net)|9.55|STANDARD_ERROR_OF_MEAN|5.262|||TWO_SIDED|95.0|-1.46|20.57|||||Comparison of QTcB Day 1.|||20.57|-1.46|
72426805|NCT00453479|144365950|SUPERIORITY_OR_OTHER||Mean Difference (Net)|8.39|STANDARD_ERROR_OF_MEAN|5.902|||TWO_SIDED|95.0|-3.97|20.74|||||Comparison of QTcB Day 7.|||20.74|-3.97|
72369576|NCT00756613|144249586|EQUIVALENCE|The equivalence margin is expected 20% reduction for the intensive treatment group compared to the standard treatment group.|Cox Proportional Hazard|1.02||||0.81|TWO_SIDED|95.0|0.88|1.18|||Regression, Cox|||||1.18|0.88|0.81
72369577|NCT00756613|144249587|EQUIVALENCE|The equivalence margin is 20% reduction of intensive treatment group versus standard treatment group.|Cox Proportional Hazard|0.9||||0.48|TWO_SIDED|95.0|0.67|1.2|||Regression, Cox|||||1.20|0.67|0.48
72369578|NCT00756613|144249589|EQUIVALENCE|T-test comparing between the two groups of treatment using the average score of last two surveys.|Mean Difference (Final Values)|1.61||||0.172|TWO_SIDED|95.0|||||t-test, 2 sided|||||||0.172
72369579|NCT03801044|144249591|OTHER|||||||0.039|||||||Wilcoxon (Mann-Whitney)|||||||0.039
72369580|NCT01326104|144249615|SUPERIORITY||comparing two curves|0.286||||0.927|TWO_SIDED|90.0|0.107|0.764||This is the p-value comparing Group A with historical control.|Log Rank|One sample log rank.||Based on published literature, PFS-12 for patients with recurrent disease after initiating treatment with HDC + PBSCT or standard salvage therapy was 33% (95% confidence interval of 10%, 59%). The study was designed to differentiate between a PFS-12 rate of 33% (null hypothesis) and 55% (alternative hypothesis). If 35 patients enrolled, this assessment has 90% power assuming a type I error rate of 0.10. We assume that PFS of historical controls follows exponential distribution.||0.764|0.107|0.927
72369581|NCT01326104|144249615|SUPERIORITY||compare two curves|0.0|||<|0.001|TWO_SIDED|||||This is the p-value comparing Group B with historical control.|Log Rank|||Based on published literature, PFS-12 for patients with recurrent disease after initiating treatment with HDC + PBSCT or standard salvage therapy was 33% (95% confidence interval of 10%, 59%). The study was designed to differentiate between a PFS-12 rate of 33% (null hypothesis) and 55% (alternative hypothesis). If 35 patients enrolled, this assessment has 90% power assuming a type I error rate of 0.10. We assume that PFS of historical controls follows exponential distribution.||||<0.001
72426806|NCT00453479|144365950|SUPERIORITY_OR_OTHER||Mean Difference (Net)|11.47|STANDARD_ERROR_OF_MEAN|5.49|||TWO_SIDED|95.0|-0.02|22.96|||||Comparison of QTcB Day 1.|||22.96|-0.02|
72426807|NCT00453479|144365950|SUPERIORITY_OR_OTHER||Mean Difference (Net)|15.28|STANDARD_ERROR_OF_MEAN|6.157|||TWO_SIDED|95.0|2.39|28.17|||||Comparison of QTcB Day 7.|||28.17|2.39|
72426808|NCT00453479|144365950|SUPERIORITY_OR_OTHER||Mean Difference (Net)|8.32|STANDARD_ERROR_OF_MEAN|4.622|||TWO_SIDED|95.0|-1.35|18.0|||||Comparison of QTcF Day 1.|||18.00|-1.35|
72426809|NCT00453479|144365950|SUPERIORITY_OR_OTHER||Mean Difference (Net)|8.75|STANDARD_ERROR_OF_MEAN|5.239|||TWO_SIDED|95.0|-2.21|19.72|||||Comparison of QTcF Day 7.|||19.72|-2.21|
72426810|NCT00453479|144365950|SUPERIORITY_OR_OTHER||Mean Difference (Net)|16.83|STANDARD_ERROR_OF_MEAN|4.759|||TWO_SIDED|95.0|6.87|26.79|||||Comparison of QTcF Day 1.|||26.79|6.87|
72426811|NCT00453479|144365950|SUPERIORITY_OR_OTHER||Mean Difference (Net)|20.46|STANDARD_ERROR_OF_MEAN|5.394|||TWO_SIDED|95.0|9.17|31.75|||||Comparison of QTcF Day 7.|||31.75|9.17|
72426812|NCT00453479|144365951|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.147|STANDARD_ERROR_OF_MEAN|0.0921|||TWO_SIDED|95.0|-0.035|0.328|||||Comparison of FEV1, Day 1, 1 hour|||0.328|-0.035|
72426813|NCT00453479|144365951|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.171|STANDARD_ERROR_OF_MEAN|0.0944|||TWO_SIDED|95.0|-0.015|0.357|||||Comparison of FEV1, Day 1, 2 hour|||0.357|-0.015|
72426814|NCT00453479|144365951|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.06|STANDARD_ERROR_OF_MEAN|0.085|||TWO_SIDED|95.0|-0.107|0.228|||||Comparison of FEV1, Day 1, 4 hour|||0.228|-0.107|
72426815|NCT00453479|144365951|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.15|STANDARD_ERROR_OF_MEAN|0.1195|||TWO_SIDED|95.0|-0.085|0.386|||||Comparison of FEV1, Day 1, 9 hour|||0.386|-0.085|
72336160|NCT05032690|144195669|EQUIVALENCE|The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. The ratio of adjusted geometric means and 90% confidence interval were expressed as percentages.|ratio of adjusted geometric means|98.21|||||TWO_SIDED|90.0|93.83|102.8|||Mixed Models Analysis|||"For comparison of Bosutinib 4\*25 mg Capsule Fed vs. Bosutinib 1\*100 mg Capsule Fed, the model is a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.~The reference treatment of Bosutinib 4\*25 mg Capsule Fed is Bosutinib 1\*100 mg Capsule Fed."||102.80|93.83|
72426816|NCT00453479|144365951|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.124|STANDARD_ERROR_OF_MEAN|0.1107|||TWO_SIDED|95.0|-0.094|0.343|||||Comparison of FEV1, Day 1, 12 hour|||0.343|-0.094|
72426817|NCT00453479|144365951|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.163|STANDARD_ERROR_OF_MEAN|0.122|||TWO_SIDED|95.0|-0.077|0.404|||||Comparison of FEV1, Day 1, 24 hour|||0.404|-0.077|
72426818|NCT00453479|144365951|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.236|STANDARD_ERROR_OF_MEAN|0.1057|||TWO_SIDED|95.0|0.027|0.444|||||Comparison of FEV1, Day 7, Baseline|||0.444|0.027|
72426819|NCT00453479|144365951|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.229|STANDARD_ERROR_OF_MEAN|0.1292|||TWO_SIDED|95.0|-0.026|0.483|||||Comparison of FEV1, Day 7, 1 hour|||0.483|-0.026|
72426820|NCT00453479|144365951|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.095|STANDARD_ERROR_OF_MEAN|0.1309|||TWO_SIDED|95.0|-0.163|0.353|||||Comparison of FEV1, Day 7, 2 hour|||0.353|-0.163|
72426821|NCT00453479|144365951|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.173|STANDARD_ERROR_OF_MEAN|0.1243|||TWO_SIDED|95.0|-0.072|0.418|||||Comparison of FEV1, Day 7, 4 hour|||0.418|-0.072|
72426822|NCT00453479|144365951|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.205|STANDARD_ERROR_OF_MEAN|0.1499|||TWO_SIDED|95.0|-0.09|0.501|||||Comparison of FEV1, Day 7, 9 hour|||0.501|-0.090|
72426823|NCT00453479|144365951|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.22|STANDARD_ERROR_OF_MEAN|0.143|||TWO_SIDED|95.0|-0.062|0.502|||||Comparison of FEV1, Day 7, 12 hour|||0.502|-0.062|
72426824|NCT00453479|144365951|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.206|STANDARD_ERROR_OF_MEAN|0.152|||TWO_SIDED|95.0|-0.093|0.506|||||Comparison of FEV1, Day 7, 24 hour|||0.506|-0.093|
72426825|NCT00453479|144365951|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.206|STANDARD_ERROR_OF_MEAN|0.097|||TWO_SIDED|95.0|0.015|0.397|||||Comparison of FEV1, Day 1, 1 hour|||0.397|0.015|
72426826|NCT00453479|144365951|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.329|STANDARD_ERROR_OF_MEAN|0.0994|||TWO_SIDED|95.0|0.133|0.525|||||Comparison of FEV1, Day 1, 2 hour|||0.525|0.133|
72426827|NCT00453479|144365951|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.266|STANDARD_ERROR_OF_MEAN|0.0895|||TWO_SIDED|95.0|0.09|0.443|||||Comparison of FEV1, Day 1, 4 hour|||0.443|0.090|
72426828|NCT00453479|144365951|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.32|STANDARD_ERROR_OF_MEAN|0.1258|||TWO_SIDED|95.0|0.072|0.568|||||Comparison of FEV1, Day 1, 9 hour|||0.568|0.072|
72426829|NCT00453479|144365951|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.172|STANDARD_ERROR_OF_MEAN|0.1165|||TWO_SIDED|95.0|-0.058|0.402|||||Comparison of FEV1, Day 1, 12 hour|||0.402|-0.058|
72426830|NCT00453479|144365951|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.154|STANDARD_ERROR_OF_MEAN|0.1285|||TWO_SIDED|95.0|-0.099|0.407|||||Comparison of FEV1, Day 1, 24 hour|||0.407|-0.099|
72426831|NCT00453479|144365951|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.256|STANDARD_ERROR_OF_MEAN|0.1113|||TWO_SIDED|95.0|0.036|0.475|||||Comparison of FEV1, Day 7, Baseline|||0.475|0.036|
72426832|NCT00453479|144365951|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.296|STANDARD_ERROR_OF_MEAN|0.1361|||TWO_SIDED|95.0|0.027|0.564|||||Comparison of FEV1, Day 7, 1 hour|||0.564|0.027|
72426833|NCT00453479|144365951|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.202|STANDARD_ERROR_OF_MEAN|0.1378|||TWO_SIDED|95.0|-0.069|0.474|||||Comparison of FEV1, Day 7, 2 hour|||0.474|-0.069|
72426834|NCT00453479|144365951|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.207|STANDARD_ERROR_OF_MEAN|0.1309|||TWO_SIDED|95.0|-0.051|0.465|||||Comparison of FEV1, Day 7, 4 hour|||0.465|-0.051|
72426835|NCT00453479|144365951|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.28|STANDARD_ERROR_OF_MEAN|0.1579|||TWO_SIDED|95.0|-0.032|0.591|||||Comparison of FEV1, Day 7, 9 hour|||0.591|-0.032|
72426836|NCT00453479|144365951|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.193|STANDARD_ERROR_OF_MEAN|0.1506|||TWO_SIDED|95.0|-0.104|0.49|||||Comparison of FEV1, Day 7, 12 hour|||0.490|-0.104|
72426837|NCT00453479|144365951|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.18|STANDARD_ERROR_OF_MEAN|0.1601|||TWO_SIDED|95.0|-0.136|0.495|||||Comparison of FEV1, Day 7, 24 hour|||0.495|-0.136|
72426838|NCT00453479|144365951|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.137|STANDARD_ERROR_OF_MEAN|0.2029|||TWO_SIDED|95.0|-0.263|0.537|||||Comparison of FVC, Day 1, 1 hour|||0.537|-0.263|
72426839|NCT00453479|144365951|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.131|STANDARD_ERROR_OF_MEAN|0.1965|||TWO_SIDED|95.0|-0.257|0.518|||||Comparison of FVC, Day 1, 2 hour|||0.518|-0.257|
72426840|NCT00453479|144365951|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.038|STANDARD_ERROR_OF_MEAN|0.1908|||TWO_SIDED|95.0|-0.414|0.338|||||Comparison of FVC, Day 1, 4 hour|||0.338|-0.414|
72426841|NCT00453479|144365951|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.06|STANDARD_ERROR_OF_MEAN|0.2013|||TWO_SIDED|95.0|-0.337|0.457|||||Comparison of FVC, Day 1, 9 hour|||0.457|-0.337|
72426842|NCT00453479|144365951|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.115|STANDARD_ERROR_OF_MEAN|0.2322|||TWO_SIDED|95.0|-0.343|0.572|||||Comparison of FVC, Day 1, 12 hour|||0.572|-0.343|
72426843|NCT00453479|144365951|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.115|STANDARD_ERROR_OF_MEAN|0.1988|||TWO_SIDED|95.0|-0.277|0.507|||||Comparison of FVC, Day 1, 24 hour|||0.507|-0.277|
72426844|NCT00453479|144365951|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.362|STANDARD_ERROR_OF_MEAN|0.2801|||TWO_SIDED|95.0|-0.19|0.914|||||Comparison of FVC, Day 7, Baseline|||0.914|-0.190|
72426845|NCT00453479|144365951|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.269|STANDARD_ERROR_OF_MEAN|0.2696|||TWO_SIDED|95.0|-0.263|0.8|||||Comparison of FVC, Day 7, 1 hour|||0.800|-0.263|
72426846|NCT00453479|144365951|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.021|STANDARD_ERROR_OF_MEAN|0.2648|||TWO_SIDED|95.0|-0.501|0.543|||||Comparison of FVC, Day 7, 2 hour|||0.543|-0.501|
72426847|NCT00453479|144365951|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.177|STANDARD_ERROR_OF_MEAN|0.2606|||TWO_SIDED|95.0|-0.337|0.691|||||Comparison of FVC, Day 7, 4 hour|||0.691|-0.337|
72426848|NCT00453479|144365951|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.266|STANDARD_ERROR_OF_MEAN|0.2684|||TWO_SIDED|95.0|-0.263|0.795|||||Comparison of FVC, Day 7, 9 hour|||0.795|-0.263|
72426849|NCT00453479|144365951|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.367|STANDARD_ERROR_OF_MEAN|0.2923|||TWO_SIDED|95.0|-0.209|0.943|||||Comparison of FVC, Day 7, 12 hour|||0.943|-0.209|
72426850|NCT00453479|144365951|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.242|STANDARD_ERROR_OF_MEAN|0.2665|||TWO_SIDED|95.0|-0.283|0.768|||||Comparison of FVC, Day 7, 24 hour|||0.768|-0.283|
72426851|NCT00453479|144365951|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.152|STANDARD_ERROR_OF_MEAN|0.2106|||TWO_SIDED|95.0|-0.263|0.567|||||Comparison of FVC, Day 1, 1 hour|||0.567|-0.263|
72426852|NCT00453479|144365951|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.321|STANDARD_ERROR_OF_MEAN|0.2039|||TWO_SIDED|95.0|-0.081|0.723|||||Comparison of FVC, Day 1, 2 hour|||0.723|-0.081|
72426853|NCT00453479|144365951|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.311|STANDARD_ERROR_OF_MEAN|0.1981|||TWO_SIDED|95.0|-0.079|0.701|||||Comparison of FVC, Day 1, 4 hour|||0.701|-0.079|
72426854|NCT00453479|144365951|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.348|STANDARD_ERROR_OF_MEAN|0.209|||TWO_SIDED|95.0|-0.064|0.76|||||Comparison of FVC, Day 1, 9 hour|||0.760|-0.064|
72426855|NCT00453479|144365951|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.245|STANDARD_ERROR_OF_MEAN|0.241|||TWO_SIDED|95.0|-0.23|0.72|||||Comparison of FVC, Day 1, 12 hour|||0.720|-0.230|
72426856|NCT00453479|144365951|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.162|STANDARD_ERROR_OF_MEAN|0.2063|||TWO_SIDED|95.0|-0.245|0.569|||||Comparison of FVC, Day 1, 24 hour|||0.569|-0.245|
72426857|NCT00453479|144365951|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.535|STANDARD_ERROR_OF_MEAN|0.2907|||TWO_SIDED|95.0|-0.038|1.108|||||Comparison of FVC, Day 7, Baseline|||1.108|-0.038|
72426858|NCT00453479|144365951|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.623|STANDARD_ERROR_OF_MEAN|0.2798|||TWO_SIDED|95.0|0.072|1.175|||||Comparison of FVC, Day 7, 1 hour|||1.175|0.072|
72426859|NCT00453479|144365951|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.459|STANDARD_ERROR_OF_MEAN|0.2748|||TWO_SIDED|95.0|-0.083|1.0|||||Comparison of FVC, Day 7, 2 hour|||1.000|-0.083|
72426860|NCT00453479|144365951|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.464|STANDARD_ERROR_OF_MEAN|0.2705|||TWO_SIDED|95.0|-0.069|0.997|||||Comparison of FVC, Day 7, 4 hour|||0.997|-0.069|
72426861|NCT00453479|144365951|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.445|STANDARD_ERROR_OF_MEAN|0.2786|||TWO_SIDED|95.0|-0.104|0.994|||||Comparison of FVC, Day 7, 9 hour|||0.994|-0.104|
72426862|NCT00453479|144365951|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.284|STANDARD_ERROR_OF_MEAN|0.3034|||TWO_SIDED|95.0|-0.314|0.882|||||Comparison of FVC, Day 7, 12 hour|||0.882|-0.314|
72426863|NCT00453479|144365951|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.384|STANDARD_ERROR_OF_MEAN|0.2766|||TWO_SIDED|95.0|-0.162|0.929|||||Comparison of FVC, Day 7, 24 hour|||0.929|-0.162|
72426864|NCT00453479|144365956|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.233|STANDARD_ERROR_OF_MEAN|3.3333|||TWO_SIDED|95.0|-4.743|9.21|||||Comparison of maximum heart rate Day 1.|||9.210|-4.743|
72426865|NCT00453479|144365956|SUPERIORITY_OR_OTHER||Mean Difference (Net)|5.73|STANDARD_ERROR_OF_MEAN|8.0907|||TWO_SIDED|95.0|-11.2|22.664|||||Comparison of maximum heart rate Day 7.|||22.664|-11.200|
72426866|NCT00453479|144365956|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.272|STANDARD_ERROR_OF_MEAN|3.239|||TWO_SIDED|95.0|-8.051|5.507|||||Comparison of maximum heart rate Day 1.|||5.507|-8.051|
72426867|NCT00453479|144365956|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.988|STANDARD_ERROR_OF_MEAN|7.8616|||TWO_SIDED|95.0|-15.47|17.443|||||Comparison of maximum heart rate Day 7.|||17.443|-15.470|
72426868|NCT00453479|144365956|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.734|STANDARD_ERROR_OF_MEAN|3.441|||TWO_SIDED|95.0|-4.468|9.936|||||Comparison of mean heart rate Day 1.|||9.936|-4.468|
72426869|NCT00453479|144365956|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.783|STANDARD_ERROR_OF_MEAN|2.9409|||TWO_SIDED|95.0|-1.372|10.938|||||Comparison of mean heart rate Day 7.|||10.938|-1.372|
72426870|NCT00453479|144365956|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.074|STANDARD_ERROR_OF_MEAN|3.3103|||TWO_SIDED|95.0|-8.003|5.854|||||Comparison of mean heart rate Day 1.|||5.854|-8.003|
72426871|NCT00453479|144365956|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.569|STANDARD_ERROR_OF_MEAN|2.8291|||TWO_SIDED|95.0|-4.353|7.49|||||Comparison of mean heart rate Day 7.|||7.490|-4.353|
72426872|NCT00453479|144365960|SUPERIORITY_OR_OTHER||Ratio|1.139|STANDARD_ERROR_OF_MEAN|0.1939|||TWO_SIDED|90.0|0.811|1.601|||||SE logs is presented as standard error of mean. Comparison of GSK233705 50 µg twice daily Day 7 versus Day 1.|||1.601|0.811|
72426873|NCT00453479|144365960|SUPERIORITY_OR_OTHER||Ratio|1.06|STANDARD_ERROR_OF_MEAN|0.2057|||TWO_SIDED|90.0|0.739|1.52|||||SE logs is presented as standard error of mean. Comparison of GSK233705 100 µg twice daily Day 7 versus Day 1.|||1.520|0.739|
72369582|NCT01326104|144249615|SUPERIORITY||Comparing two curves|0.091|||<|0.001|TWO_SIDED|90.0|0.03|0.276||This is the p-value comparing Groups A and B combined with historical control.|Log Rank|||||0.276|0.03|<0.001
72369583|NCT01287741|144249621|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.94||||0.4753|TWO_SIDED|95.0|0.78|1.12|||Log Rank|Stratified by International Prognostic Index (IPI) score (low/low-intermediate (excluding participants having an IPI score 0 without bulky disease).||||1.12|0.78|0.4753
72369584|NCT01287741|144249622|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.89||||0.2736|TWO_SIDED|95.0|0.72|1.1|||Log Rank|Stratified by International Prognostic Index (IPI) score (low/low-intermediate (excluding participants having an IPI score 0 without bulky disease).||||1.10|0.72|0.2736
72369585|NCT04421027|144249637|SUPERIORITY||Odds Ratio (OR)|0.85||||0.18|TWO_SIDED|95.0|0.67|1.08|||Regression, Logistic|||||1.08|0.67|0.1800
72369586|NCT04421027|144249638|SUPERIORITY||Odds Ratio (OR)|1.12||||0.728|TWO_SIDED|95.0|0.58|2.16|||Regression, Logistic|||||2.16|0.58|0.7280
72369587|NCT04421027|144249639|SUPERIORITY||Odds Ratio (OR)|1.07||||0.5444|TWO_SIDED|95.0|0.86|1.34|||Regression, Logistic|||||1.34|0.86|0.5444
72369588|NCT04421027|144249640|SUPERIORITY||LS Mean difference (net)|0.75|STANDARD_ERROR_OF_MEAN|0.399||0.0586|TWO_SIDED|95.0|0.0|1.5|||ANOVA|||||1.5|-0.0|0.0586
72369589|NCT04421027|144249641|SUPERIORITY||Hazard Ratio (HR)|1.11||||0.1453|TWO_SIDED|95.0|0.99|1.24|||Log Rank|||||1.24|0.99|0.1453
72369590|NCT04421027|144249642|SUPERIORITY||Odds Ratio (OR)|1.21||||0.0464|TWO_SIDED|95.0|1.0|1.47|||Proportional Odds Model|||Day 4||1.47|1.00|0.0464
72369591|NCT04421027|144249643|SUPERIORITY||Odds Ratio (OR)|1.25||||0.0172|TWO_SIDED|95.0|1.04|1.49|||Proportional Odds Model|||||1.49|1.04|0.0172
72369592|NCT04421027|144249644|SUPERIORITY||Odds Ratio (OR)|1.17||||0.0921|TWO_SIDED|95.0|0.97|1.41|||Proportional Odds Model|||||1.41|0.97|0.0921
72369593|NCT04421027|144249645|SUPERIORITY||Odds Ratio (OR)|1.28||||0.0168|TWO_SIDED|95.0|1.05|1.56|||Proportional Odds Model|||||1.56|1.05|0.0168
72369594|NCT04421027|144249646|SUPERIORITY||LS Mean Difference (Net)|-0.76|STANDARD_ERROR_OF_MEAN|0.408||0.0626|TWO_SIDED|95.0|-1.6|0.0|||ANOVA|||||0.0|-1.6|0.0626
72369595|NCT04421027|144249647|SUPERIORITY||Odds Ratio (OR)|1.15||||0.429|TWO_SIDED|95.0|0.81|1.63|||Regression, Logistic|||||1.63|0.81|0.4290
72369596|NCT04421027|144249648|SUPERIORITY||Hazard Ratio (HR)|0.57||||0.0018|TWO_SIDED|95.0|0.41|0.78|||Log Rank|||||0.78|0.41|0.0018
72369597|NCT04421027|144249649|SUPERIORITY||LS Mean Difference (Net)|0.02|STANDARD_ERROR_OF_MEAN|0.323||0.9526|TWO_SIDED|95.0|-0.62|0.65|||ANOVA|||||0.65|-0.62|0.9526
72369598|NCT04421027|144249650|SUPERIORITY||Hazard Ratio (HR)|0.887||||0.1831|TWO_SIDED|95.0|0.741|1.061|||Log Rank|||||1.061|0.741|0.1831
72369599|NCT04421027|144249651|SUPERIORITY||Hazard Ratio (HR)|1.202||||0.0243|TWO_SIDED|95.0|1.017|1.421|||Log Rank|||||1.421|1.017|0.0243
72369600|NCT04421027|144249652|SUPERIORITY||LS Mean Difference (Final Values)|-0.17|STANDARD_ERROR_OF_MEAN|0.128||0.191|TWO_SIDED|95.0|-0.42|0.08|||Mixed Models Analysis|||Day 4||0.08|-0.42|0.191
72369601|NCT04421027|144249652|SUPERIORITY||LS Mean Difference (Final Values)|-0.17|STANDARD_ERROR_OF_MEAN|0.161||0.278|TWO_SIDED|95.0|-0.49|0.14|||Mixed Models Analysis|||Day 7||0.14|-0.49|0.278
72369602|NCT04421027|144249652|SUPERIORITY||LS Mean Difference (Final Values)|-0.13|STANDARD_ERROR_OF_MEAN|0.187||0.496|TWO_SIDED|95.0|-0.49|0.24|||Mixed Models Analysis|||Day 10||0.24|-0.49|0.496
72369603|NCT04421027|144249652|SUPERIORITY||LS Mean Difference (Final Values)|-0.25|STANDARD_ERROR_OF_MEAN|0.226||0.263|TWO_SIDED|95.0|-0.7|0.19|||Mixed Models Analysis|||Day 14||0.19|-0.70|0.263
72369604|NCT04421027|144249654|SUPERIORITY||Hazard Ratio (HR)|1.09||||0.6436|TWO_SIDED||||||Log Rank|||||||0.6436
72369605|NCT04421027|144249655|SUPERIORITY||Hazard Ratio (HR)|1.124||||0.127|TWO_SIDED||||||Log Rank|||||||0.1270
72369606|NCT04421027|144249656|SUPERIORITY||LS Mean Difference (Net)|-0.23|STANDARD_ERROR_OF_MEAN|0.228||0.3058|TWO_SIDED|95.0|-0.68|0.21|||ANOVA|||||0.21|-0.68|0.3058
72369607|NCT04421027|144249657|SUPERIORITY||LS Mean Difference (Net)|0.11|STANDARD_ERROR_OF_MEAN|0.306||0.7073|TWO_SIDED|95.0|-0.49|0.72|||ANOVA|||||0.72|-0.49|0.7073
72369608|NCT05407064|144249685|SUPERIORITY|Mean change from baseline and mean difference between MM120 dose groups and placebo were estimated using model averaging method (of 3 models). The minimally efficacious dose was defined as a placebo-adjusted improvement of 2.5 points on the HAM-A, with a statistical significance set at an alpha level of 0.05.||||||||||||||||The primary endpoint was evaluated by determining if there was a dose-response relationship between the change from baseline to Week 4 in total HAM-A score and the dose administered using the Multiple Comparison Procedure - Modelling (MCP-Mod) methodology. Several candidate parametric models were assumed, and multiple comparison techniques were used to choose the model(s) likely to present the true underlying dose-response curve.|A test statistic was derived from the data using an ANCOVA model with change from Baseline to Week 4 for the HAM-A Total Score as a response variable, treatment arm and Baseline value of HAM-A Total Score as covariates. The ANCOVA model was repeated for each imputed dataset, which resulted in a set of LS mean estimates for all dose groups and the related covariance matrices. Rubin's rule was used to combine the multiple sets of LS mean estimates and the related covariance matrices to a single set of LS mean estimates of change from Baseline to Week 4 for HAM-A Total Score for all dose groups and the related covariance matrix. The SAS procedure PROC MIANALYZE was used to combine the results from imputed datasets.|||
72336161|NCT05032690|144195669|EQUIVALENCE|The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. The ratio of adjusted geometric means and 90% confidence interval were expressed as percentages.|ratio of adjusted geometric means|146.7|||||TWO_SIDED|90.0|117.88|182.58|||Mixed Models Analysis|||"For comparison of Bosutinib 1\*100 mg Capsule Fed vs. Bosutinib 1\*100 mg Capsule Fasted, the model is a mixed effect model with sequence and treatment as fixed effects and participant within sequence as a random effect.~The reference treatment of Bosutinib 1\*100 mg Capsule Fed is Bosutinib 1\*100 mg Capsule Fasted."||182.58|117.88|
72336162|NCT00835640|144195696|NON_INFERIORITY_OR_EQUIVALENCE|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|81.33||||||90.0|||||||To establish bioequivalence, the ratio of the mean must fall within 80-125.|||||
72369636|NCT05407064|144249693|SUPERIORITY|||||||0.0816|||||||t-test, 2 sided|||Change from baseline in total MADRS scores determined by the difference in means and difference between treatment and placebo (p-value determined from two-sample t-test).||||0.0816
72369637|NCT05407064|144249693|SUPERIORITY|||||||0.019|||||||t-test, 2 sided|||Change from baseline in total MADRS scores determined by the difference in means and difference between treatment and placebo (p-value determined from two-sample t-test).||||0.0190
72369638|NCT05407064|144249694|SUPERIORITY|||||||0.5647|||||||t-test, 2 sided|||Change from baseline in total MADRS scores determined by the difference in means and difference between treatment and placebo (p-value determined from two-sample t-test).||||0.5647
72369639|NCT05407064|144249694|SUPERIORITY|||||||0.3497|||||||t-test, 2 sided|||Change from baseline in total MADRS scores determined by the difference in means and difference between treatment and placebo (p-value determined from two-sample t-test).||||0.3497
72369640|NCT05407064|144249694|SUPERIORITY|||||||0.0229|||||||t-test, 2 sided|||Change from baseline in total MADRS scores determined by the difference in means and difference between treatment and placebo (p-value determined from two-sample t-test).||||0.0229
72369641|NCT05407064|144249694|SUPERIORITY|||||||0.0073|||||||t-test, 2 sided|||Change from baseline in total MADRS scores determined by the difference in means and difference between treatment and placebo (p-value determined from two-sample t-test).||||0.0073
72369642|NCT05407064|144249695|SUPERIORITY|||||||0.0158|||||||t-test, 2 sided|||Change from baseline in total CGI-S scores determined by the difference in means and difference between treatment and placebo (p-value determined from two-sample t-test).||||0.0158
72369643|NCT05407064|144249695|SUPERIORITY|||||||0.0429|||||||t-test, 2 sided|||Change from baseline in total CGI-S scores determined by the difference in means and difference between treatment and placebo (p-value determined from two-sample t-test).||||0.0429
72369644|NCT05407064|144249695|SUPERIORITY|||||||0.0001|||||||t-test, 2 sided|||Change from baseline in total CGI-S scores determined by the difference in means and difference between treatment and placebo (p-value determined from two-sample t-test).||||0.0001
72369645|NCT05407064|144249695|SUPERIORITY|||||||0|||||||t-test, 2 sided|||Change from baseline in total CGI-S scores determined by the difference in means and difference between treatment and placebo (p-value determined from two-sample t-test).||||0.0000
72369646|NCT05407064|144249696|SUPERIORITY|||||||0.0804|||||||t-test, 2 sided|||Change from baseline in total CGI-S scores determined by the difference in means and difference between treatment and placebo (p-value determined from two-sample t-test).||||0.0804
72369647|NCT05407064|144249696|SUPERIORITY|||||||0.0532|||||||t-test, 2 sided|||Change from baseline in total CGI-S scores determined by the difference in means and difference between treatment and placebo (p-value determined from two-sample t-test).||||0.0532
72369648|NCT05407064|144249696|SUPERIORITY|||||||0.0001|||||||t-test, 2 sided|||Change from baseline in total CGI-S scores determined by the difference in means and difference between treatment and placebo (p-value determined from two-sample t-test).||||0.0001
72369649|NCT05407064|144249696|SUPERIORITY|||||||0|||||||t-test, 2 sided|||Change from baseline in total CGI-S scores determined by the difference in means and difference between treatment and placebo (p-value determined from two-sample t-test).||||0.0000
72369650|NCT05407064|144249697|SUPERIORITY|||||||0.2152|||||||t-test, 2 sided|||Assessment of change from baseline in total CGI-S scores determined by the difference in means and difference between treatment and placebo (p-value determined from two-sample t-test).||||0.2152
72369651|NCT05407064|144249697|SUPERIORITY|||||||0.3369|||||||t-test, 2 sided|||Assessment of change from baseline in total CGI-S scores determined by the difference in means and difference between treatment and placebo (p-value determined from two-sample t-test).||||0.3369
72369652|NCT05407064|144249697|SUPERIORITY|||||||0.001|||||||t-test, 2 sided|||Assessment of change from baseline in total CGI-S scores determined by the difference in means and difference between treatment and placebo (p-value determined from two-sample t-test).||||0.0010
72369653|NCT05407064|144249697|SUPERIORITY|||||||0.0046|||||||t-test, 2 sided|||Assessment of change from baseline in total CGI-S scores determined by the difference in means and difference between treatment and placebo (p-value determined from two-sample t-test).||||0.0046
72369654|NCT05407064|144249698|SUPERIORITY|||||||0.4489|||||||t-test, 2 sided|||Change from baseline in total CGI-S scores determined by the difference in means and difference between treatment and placebo (p-value determined from two-sample t-test).||||0.4489
72369655|NCT05407064|144249698|SUPERIORITY|||||||0.7326|||||||t-test, 2 sided|||Change from baseline in total CGI-S scores determined by the difference in means and difference between treatment and placebo (p-value determined from two-sample t-test).||||0.7326
72426874|NCT00453479|144365961|SUPERIORITY_OR_OTHER||Ratio|1.408|STANDARD_ERROR_OF_MEAN|0.234|||TWO_SIDED|90.0|0.934|2.122|||||SE logs is presented as standard error of mean. Comparison of Cmax AM dose for GSK233705 50 µg twice daily Day 7 versus Day 1.|||2.122|0.934|
72426875|NCT00453479|144365961|SUPERIORITY_OR_OTHER||Ratio|1.19|STANDARD_ERROR_OF_MEAN|0.2482|||TWO_SIDED|90.0|0.77|1.838|||||SE logs is presented as standard error of mean. Comparison of Cmax AM dose for GSK233705 100 µg twice daily Day 7 versus Day 1.|||1.838|0.770|
72426876|NCT00453479|144365961|SUPERIORITY_OR_OTHER||Ratio|0.979|STANDARD_ERROR_OF_MEAN|0.2269|||TWO_SIDED|90.0|0.658|1.457|||||SE logs is presented as standard error of mean. Comparison of Cmax PM dose for GSK233705 50 µg twice daily Day 7 versus Day 1.|||1.457|0.658|
72426877|NCT00453479|144365961|SUPERIORITY_OR_OTHER||Ratio|1.028|STANDARD_ERROR_OF_MEAN|0.2407|||TWO_SIDED|90.0|0.674|1.568|||||SE logs is presented as standard error of mean. Comparison of Cmax PM dose for GSK233705 100 µg twice daily Day 7 versus Day 1.|||1.568|0.674|
72426878|NCT00453479|144365963|SUPERIORITY_OR_OTHER||Ratio|2.556|STANDARD_ERROR_OF_MEAN|0.131|||TWO_SIDED|90.0|2.033|3.213|||||SE logs is presented as standard error of mean. Comparison of Ae AM dose for GSK233705 50 µg twice daily Day 7 versus Day 1.|||3.213|2.033|
72336163|NCT00835640|144195697|NON_INFERIORITY_OR_EQUIVALENCE|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|87.87||||||90.0|||||||To establish bioequivalence, the ratio of the mean must fall within 80-125.|||||
72336164|NCT00835640|144195698|NON_INFERIORITY_OR_EQUIVALENCE|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|88.45||||||90.0|||||||To establish bioequivalence, the ratio of the mean must fall within 80-125.|||||
72369486|NCT00048074|144249148|NON_INFERIORITY_OR_EQUIVALENCE|The IV dosing regimen (2mg q 2 mo IV) was considered non-inferior to the 2.5 mg daily regimen if the lower bound of the two-sided 95% CI on the difference in mean percent change in BMD was greater or equal to -1 percentage point.|Mean Difference (Final Values)|1.257|||<|0.001|TWO_SIDED|95.0|0.701|1.814|||ANOVA||Treatment effect is the difference in the mean values of the IV regimen (2mg q 2 mo IV) and the active-control.|The primary hypothesis was that the difference in the effects of daily oral ibandronate and IV ibandronate (2mg q 2 mo IV) on the relative change in lumbar spine BMD (L2 - L4) was small, no more than 1%, the margin of clinical equivalence.||1.814|0.701|<0.001
72426879|NCT00453479|144365963|SUPERIORITY_OR_OTHER||Ratio|1.644|STANDARD_ERROR_OF_MEAN|0.138|||TWO_SIDED|90.0|1.29|2.095|||||SE logs is presented as standard error of mean. Comparison of Ae AM dose for GSK233705 100 µg twice daily Day 7 versus Day 1.|||2.095|1.290|
72426880|NCT01763788|144365974|SUPERIORITY||Stratified Hazard Ratio|0.656||||0.0161|TWO_SIDED|95.0|0.465|0.926|||Stratified Log Rank|||||0.926|0.465|0.0161
72426881|NCT02354859|144365988|SUPERIORITY||Difference in Proportions|5.9||||0.811|TWO_SIDED|95.0|-11.2|22.4|||Cochran-Mantel-Haenszel||The estimate is adjusted for baseline FEV1 % predicted strata (\<50% of predicted, between 50% and 70% of predicted, and \>70% of predicted).|||22.4|-11.2|0.811
72426882|NCT02354859|144365989|SUPERIORITY||Difference in Proportions-SAE inicidence|3.1||||0.807|TWO_SIDED|95.0|-10.6|16.6|||Fisher Exact||95% confidence interval calculated using the Newcombe-Wilson method without continuity correction.|||16.6|-10.6|0.807
72426883|NCT02354859|144365990|SUPERIORITY||Rate Ratio|0.81||||0.002|TWO_SIDED|95.0|0.71|0.93|||Poisson Regression|||Rate Ratio for Adverse Events calculated using Poisson Regression with an offset for the log of follow-up time in weeks. The total number of follow-up weeks of all participants (not per participant) in the trial was as follows: in the IV Gallium group was 486.86 and in the Placebo group was 473.57.||0.93|0.71|0.002
72426884|NCT02354859|144365990|SUPERIORITY||Rate Ratio|0.89||||0.783|TWO_SIDED|95.0|0.39|2.03|||Poisson Regression|||Rate Ratio for Serious Adverse Events calculated using Poisson Regression with an offset for the log of follow-up time in weeks. The total number of follow-up weeks in the IV Gallium group was 486.86 and in the Placebo group was 473.57.||2.03|0.39|0.783
72426885|NCT02354859|144365991|SUPERIORITY||Mean Difference (Final Values)|2.05||||0.479|TWO_SIDED|95.0|-3.66|7.77|||Mixed Models Analysis||Analysis includes all data for relative change from baseline at Day 6, Day 14, Day 28, and Day 56. Mixed-effects repeated measures model includes terms for the baseline FEV1 (liters), treatment, visit and a visit-by-visit interaction.|||7.77|-3.66|0.479
72426886|NCT02354859|144365992|SUPERIORITY||Mean Difference (Final Values)|-0.74||||0.054|TWO_SIDED|95.0|-1.49|0.01|||Mixed Models Analysis||Analysis includes all data for relative change from baseline at Day 28 and Day 56. Mixed-effects repeated measures model includes terms for the baseline Pa density (log10 (CFU)), treatment, visit and a visit-by-visit interaction.|||0.01|-1.49|0.054
72426887|NCT02354859|144365993|SUPERIORITY||Mean Difference (Final Values)|4.23||||0.053|TWO_SIDED|95.0|-0.06|8.53|||Mixed Models Analysis||Analysis includes all data for relative change from baseline at Day 6, Day 14, Day 28, and Day 56. Mixed-effects repeated measures model includes terms for the baseline CFRSD-CRISS score, treatment, visit and a visit-by-visit interaction.|||8.53|-0.06|0.053
72426888|NCT00708305|144365999|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.0||||0.9762||95.0|-0.21|0.2||No adjustment was made for multiple comparisons as the primary comparison was predefined.|ANCOVA|The model included mean baseline fluoride level for treatment period (covariate), treatment and period as fixed and subject was random factor.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis is no difference between treatments in comparison. Tests were 2-sided at 5% significance levels.||0.20|-0.21|0.9762
72426889|NCT00708305|144366000|SUPERIORITY_OR_OTHER||Adjusted Mean DIfference|0.49|||<|0.0001|TWO_SIDED|95.0|0.28|0.7||No adjustment was made for multiple comparisons as the comparisons were predefined.|ANCOVA|The model included mean baseline fluoride level for treatment period (covariate), treatment and period as fixed and subject was random factor.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis is no difference between treatments being compared. Tests were 2 sided at 5% significance levels.||0.70|0.28|<0.0001
72426890|NCT00708305|144366000|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|1.44|||<|0.0001||95.0|1.23|1.65||No adjustment was made for multiple comparisons because the comparisons were predefined.|ANCOVA|The model included mean baseline fluoride level for treatment period (covariate), treatment and period as fixed and subject was random factor.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments, being compared. Tests were 2 sided at 5% significance levels.||1.65|1.23|<0.0001
72426891|NCT00708305|144366000|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.49|||<|0.0001||95.0|0.28|0.7||No adjustment was made for multiple comparisons because the comparisons were predefined.|ANCOVA|The model included mean baseline fluoride level for treatment period (covariate), treatment and period as fixed and subject was random factor.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments, being compared. Tests were 2 sided at 5% significance levels.||0.70|0.28|<0.0001
72426892|NCT00708305|144366000|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|1.44|||<|0.0001|TWO_SIDED|95.0|1.23|1.65||No adjustment was made for multiple comparisons because the comparison was predefined.|ANCOVA|The model included mean baseline fluoride level for treatment period (covariate), treatment and period as fixed and subject was random factor.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments, being compared. Tests were 2 sided at 5% significance levels.||1.65|1.23|<0.0001
72426893|NCT00708305|144366000|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.95|||<|0.0001|TWO_SIDED|95.0|0.74|1.16||No adjustment was made for multiple comparisons as the comparisons were predefined.|ANCOVA|The model included mean baseline fluoride level for treatment period (covariate), treatment and period as fixed and subject was random factor.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments, being compared. Tests were 2 sided at 5% significance levels.||1.16|0.74|<0.0001
72426894|NCT00708305|144366001|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.83||||0.0151|TWO_SIDED|95.0|0.12|1.72||No adjustments for multiple comparisons were made as the primary comparison was pre-defined.|Wilcoxon Signed Rank Test||Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments, being compared. Statistical tests were 2-sided at 5% significance level.||1.72|0.12|0.0151
72426895|NCT00708305|144366001|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|1.36|||<|0.0001|TWO_SIDED|95.0|0.69|2.36||No adjustments for multiple comparisons were made as the primary comparison was pre-defined.|Wilcoxon Signed Rank Test||Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments, being compared. Statistical tests were 2-sided at 5% significance level.||2.36|0.69|<0.0001
72426896|NCT00708305|144366001|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|3.01|||<|0.0001|TWO_SIDED|95.0|2.06|4.05||No adjustments for multiple comparisons were made as the primary comparison was pre-defined.|Wilcoxon Signed Rank Test||Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis is no difference between treatments. Tests were 2-sided.||4.05|2.06|<0.0001
72426897|NCT00708305|144366001|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.75|||<|0.0001|TWO_SIDED|95.0|0.41|1.27||No adjustments for multiple comparisons were made as the primary comparison was pre-defined.|Wilcoxon Signed Rank Test||Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments, being compared. Statistical tests were 2-sided at 5% significance level.||1.27|0.41|<0.0001
72426898|NCT00708305|144366001|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|2.1|||<|0.0001|TWO_SIDED|95.0|1.5|2.74||No adjustments for multiple comparisons were made as the primary comparison was pre-defined.|Wilcoxon Signed Rank Test||Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments, being compared. Statistical tests were 2-sided at 5% significance level.||2.74|1.50|<0.0001
72426899|NCT00708305|144366001|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|1.01|||<|0.0001|TWO_SIDED|95.0|0.73|1.35||No adjustments for multiple comparisons were made as the primary comparison was pre-defined.|Wilcoxon Signed Rank Test||Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments, being compared. Statistical tests were 2-sided at 5% significance level.||1.35|0.73|<0.0001
72426900|NCT00708305|144366002|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.08||||0.5545|TWO_SIDED|95.0|-0.22|0.47||No adjustments for multiple comparisons were made as the primary comparison was pre-defined.|Wilcoxon Signed Rank Test||Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments, being compared. Statistical tests were 2-sided at 5% significance level.||0.47|-0.22|0.5545
72336165|NCT00068250|144195699|OTHER||||||||||||||||||Dose escalation followed the standard 3+3 design, although up to six patients could be accrued per dose level before suspending accrual for toxicity evaluation. If none of the first three patients (0/3), or one of the first three and none of the second three (1/3 and 0/3), experience a DLT, then the current dose level would be considered acceptable, and the next dose opened. Otherwise, the current dose level would be considered too toxic. The highest dose achieved with an acceptable level of toxicity was to considered the Maximum Tolerable Dose (MTD). If at any time a grade 5 toxicity was observed, accrual will be suspended, and the Study Chair would review the event. Furthermore, if the cumulative incidence (obtained by time to event analysis), at any time, of combined acute/late DLTs estimated the toxicity rate to be greater than 30% at any dose level, then the Executive Committee will be notified, and the committee would determine whether to stop accrual.|||
72426901|NCT00708305|144366002|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.4||||0.0003|TWO_SIDED|95.0|0.15|0.71||No adjustments for multiple comparisons were made as the primary comparison was pre-defined.|Wilcoxon Signed Rank Test||Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments, being compared. Statistical tests were 2-sided at 5% significance level.||0.71|0.15|0.0003
72426902|NCT00708305|144366002|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.91|||<|0.0001|TWO_SIDED|95.0|0.58|1.56||No adjustments for multiple comparisons were made as the primary comparison was pre-defined.|Wilcoxon Signed Rank Test||Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments, being compared. Statistical tests were 2-sided at 5% significance level.||1.56|0.58|<0.0001
72426903|NCT00708305|144366002|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.36|||<|0.0001|TWO_SIDED|95.0|0.15|0.68||No adjustments for multiple comparisons were made as the primary comparison was pre-defined.|Wilcoxon Signal Rank Test||Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments, being compared. Statistical tests were 2-sided at 5% significance level.||0.68|0.15|<0.0001
72426904|NCT00708305|144366002|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.91|||<|0.0001|TWO_SIDED|95.0|0.58|1.35||No adjustments for multiple comparisons were made as the primary comparison was pre-defined.|Wilcoxon Signed Rank Test||Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments, being compared. Statistical tests were 2-sided at 5% significance level.||1.35|0.58|<0.0001
72426905|NCT00708305|144366002|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.37|||<|0.0001|TWO_SIDED|95.0|0.26|0.56||No adjustments for multiple comparisons were made as the primary comparison was pre-defined.|Wilcoxon Signed Rank Test||Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments, being compared. Statistical tests were 2-sided at 5% significance level.||0.56|0.26|<0.0001
72426906|NCT00708305|144366003|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.02||||0.6865|TWO_SIDED|95.0|-0.13|0.08||No adjustments for multiple comparisons were made as the primary comparison was pre-defined.|Wilcoxon Signed Rank Test||Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments, being compared. Statistical tests were 2-sided at 5% significance level.||0.08|-0.13|0.6865
72426907|NCT00708305|144366003|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.04||||0.1756|TWO_SIDED|95.0|-0.02|0.12||No adjustments for multiple comparisons were made as the primary comparison was pre-defined.|Wilcoxon Signed Rank Test||Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments, being compared. Statistical tests were 2-sided at 5% significance level.||0.12|-0.02|0.1756
72426908|NCT00708305|144366003|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.24|||<|0.0001|TWO_SIDED|95.0|0.16|0.38||No adjustments for multiple comparisons were made as the primary comparison was pre-defined.|Wilcoxon Signed Rank Test||Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments, being compared. Statistical tests were 2-sided at 5% significance level.||0.38|0.16|<0.0001
72426909|NCT00708305|144366003|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.11||||0.0023|TWO_SIDED|95.0|0.04|0.22||No adjustments for multiple comparisons were made as the primary comparison was pre-defined.|Wilcoxon Signed Rank Test||Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments, being compared. Statistical tests were 2-sided at 5% significance level.||0.22|0.04|0.0023
72426910|NCT00708305|144366003|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.34|||<|0.0001|TWO_SIDED|95.0|0.22|0.51||No adjustments for multiple comparisons were made as the primary comparison was pre-defined.|Wilcoxon Signed Rank Test||Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments, being compared. Statistical tests were 2-sided at 5% significance level.||0.51|0.22|<0.0001
72426911|NCT00708305|144366003|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.18|||<|0.0001|TWO_SIDED|95.0|0.12|0.25||No adjustments for multiple comparisons were made as the primary comparison was pre-defined.|Wilcoxon Signed Rank Test||Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments, being compared. Statistical tests were 2-sided at 5% significance level.||0.25|0.12|<0.0001
72426912|NCT00708305|144366004|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.04||||0.0783|TWO_SIDED|95.0|-0.08|0.0||No adjustments for multiple comparisons were made as the primary comparison was pre-defined.|Wilcoxon Signed Rank Test||Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments, being compared. Statistical tests were 2-sided at 5% significance level.||0.00|-0.08|0.0783
72426913|NCT00708305|144366004|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.03||||0.0531|TWO_SIDED|95.0|0.0|0.07||No adjustments for multiple comparisons were made as the primary comparison was pre-defined.|Wilcoxon Signed Rank Test||Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments, being compared. Statistical tests were 2-sided at 5% significance level.||0.07|0.00|0.0531
72426914|NCT00708305|144366004|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.1|||<|0.0001|TWO_SIDED|95.0|0.07|0.14||No adjustments for multiple comparisons were made as the primary comparison was pre-defined.|Wilcoxon Signed Rank Test||Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments, being compared. Statistical tests were 2-sided at 5% significance level.||0.14|0.07|<0.0001
72426915|NCT00708305|144366004|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.08||||0.0005|TWO_SIDED|95.0|0.03|0.15||No adjustments for multiple comparisons were made as the primary comparison was pre-defined.|Wilcoxon Signed Rank Test||Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments, being compared. Statistical tests were 2-sided at 5% significance level.||0.15|0.03|0.0005
72426916|NCT00708305|144366004|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.12|||<|0.0001|TWO_SIDED|95.0|0.08|0.2||No adjustments for multiple comparisons were made as the primary comparison was pre-defined.|Wilcoxon Signed Rank Test||Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments, being compared. Statistical tests were 2-sided at 5% significance level.||0.20|0.08|<0.0001
72336166|NCT00068250|144195700|SUPERIORITY|||||||0.006|||||||One-sample z-test|||Null hypothesis: Two-year survival rate \<= 64%; Alternative hypothesis: Two-year survival rate \> 64%. The fixed survival rate for comparison comes from Radiation Therapy Oncology Group (RTOG) trial 9310. (RTOG 9310 does not fall within ClinicalTrials.gov registration/reporting requirements.)||||0.006
72336167|NCT00068250|144195701|OTHER|||||||0.82|||||||Chi-squared|One-sample test of proportions||RTOG 93-10 reported a pre-irradiation chemotherapy complete response rate of 59%. A chi-square test with a 0.20 one-sided significance level provides 81% power to detect the difference between a null hypothesis complete response rate of 59% and the alternative rate of 71% (a 20% increase) for the planned sample size of 52 patients.||||0.82
72336168|NCT04035564|144195759|SUPERIORITY||Risk Ratio (RR)|0.2||||0.71|TWO_SIDED|95.0|0.026|1.533|||Chi-squared|||||1.533|0.026|0.71
72336169|NCT04035564|144195760|SUPERIORITY||Risk Ratio (RR)|1.21||||0.89|TWO_SIDED|95.0|0.081|18.09|||Chi-squared|||||18.09|0.081|0.89
72336170|NCT04035564|144195761|SUPERIORITY||Mean Difference (Final Values)|-2.861|STANDARD_ERROR_OF_MEAN|1.286||0.032|TWO_SIDED|95.0|-5.461|-0.261|||t-test, 2 sided|||||-0.261|-5.461|0.032
72336171|NCT04035564|144195761|SUPERIORITY||Mean Difference (Final Values)|-2.86|STANDARD_ERROR_OF_MEAN|1.286||0.032|TWO_SIDED|95.0|-5.461|-0.261|||ANOVA|||||-0.261|-5.461|0.032
72336172|NCT04035564|144195762|SUPERIORITY||Mean Difference (Final Values)|-3.788|STANDARD_ERROR_OF_MEAN|2.299||0.107|TWO_SIDED|95.0|-8.43|0.858|||t-test, 2 sided|||||0.858|-8.43|0.107
72336173|NCT04035564|144195762|SUPERIORITY||Mean Difference (Final Values)|-3.78|STANDARD_ERROR_OF_MEAN|2.299||0.107|TWO_SIDED|95.0|-8.43|0.85|||ANOVA|||||0.85|-8.43|0.107
72336174|NCT04035564|144195763|SUPERIORITY||Mean Difference (Final Values)|-39.38|STANDARD_ERROR_OF_MEAN|17.22||0.028|TWO_SIDED|95.0|-74.18|-4.57|||t-test, 2 sided|||||-4.57|-74.18|0.028
72336175|NCT04035564|144195763|SUPERIORITY||Mean Difference (Final Values)|-39.38|STANDARD_ERROR_OF_MEAN|17.22||0.028|TWO_SIDED|95.0|-74.18|-4.57|||ANOVA|||||-4.57|-74.18|0.028
72336176|NCT04035564|144195764|SUPERIORITY||Risk Ratio (RR)|0.75||||0.55|TWO_SIDED|95.0|0.296|1.932|||Chi-squared|||||1.932|0.296|0.55
72336177|NCT04035564|144195765|SUPERIORITY||Risk Ratio (RR)|1.09||||0.84|TWO_SIDED|95.0|0.169|7.096|||Chi-squared|||||7.096|0.169|0.84
72336178|NCT04035564|144195766|SUPERIORITY||Risk Ratio (RR)|0.8||||0.7|TWO_SIDED|95.0|0.266|2.448|||Chi-squared|||||2.448|0.266|0.70
72336179|NCT04035564|144195767|SUPERIORITY|||||||0.33|||||||Chi-squared|||||||0.33
72336180|NCT04035564|144195767|SUPERIORITY||Hazard Ratio (HR)|0.62||||0.57|TWO_SIDED||||||Regression, Cox|||||||0.57
72336181|NCT03344549|144195797|SUPERIORITY||Mean Difference (Final Values)|-1.76|STANDARD_DEVIATION|0.8||0.37|TWO_SIDED|95.0||||The threshoid for statistical significance was p \<0.05|t-test, 2 sided|||U Mann Whitney was used for inter-group comparison||||0.37
72336182|NCT03344549|144195798|SUPERIORITY||Mean Difference (Final Values)|-1.76|STANDARD_DEVIATION|0.8||0.46|TWO_SIDED|95.0||||The threshold for statistical significance was p\<0.05|t-test, 2 sided|U Mann Whitney was used for inter-group comparison||||||0.46
72336183|NCT03344549|144195799|SUPERIORITY|||||||0.16|||||||Chi-squared|||||||0.16
72336184|NCT00108303|144195806|SUPERIORITY_OR_OTHER||Log (odd ratio)|5.2|||||TWO_SIDED|||||||||||||
72336185|NCT00108303|144195806|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||This parameter was estimated by simulating 1000 samples with random genotypes and finding no value equal to or greater than 5.2.|Simulation|||||||<0.001
72336186|NCT00108303|144195807|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED||||||Firsher's transform r to Z|||The coefficient of segregation versus no segregation of the P50 sensory gating percent in families with schizophrenia.||||0.001
72336187|NCT01007123|144195818|SUPERIORITY_OR_OTHER||||||<|0.2|TWO_SIDED|0.0|||||ANCOVA|||||||<0.2
72336188|NCT01007123|144195818|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED|0.0|||||ANCOVA|||||||0.002
72336189|NCT01007123|144195818|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|0.0|||||ANCOVA|||||||<0.001
72336190|NCT01007123|144195819|SUPERIORITY_OR_OTHER|||||||0.03|TWO_SIDED|0.0|||||Fisher Exact|||||||0.03
72336191|NCT01007123|144195819|SUPERIORITY_OR_OTHER|||||||0.008|TWO_SIDED|0.0|||||Fisher Exact|||||||0.008
72336192|NCT01007123|144195819|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|0.0|||||Fisher Exact|||||||<0.001
72336193|NCT01007123|144195820|SUPERIORITY_OR_OTHER|||||||0.06|TWO_SIDED|0.0|||||Fisher Exact|||||||0.06
72336194|NCT01007123|144195820|SUPERIORITY_OR_OTHER|||||||0.03|TWO_SIDED|0.0|||||Fisher Exact|||||||0.03
72336195|NCT01007123|144195820|SUPERIORITY_OR_OTHER|||||||0.04|TWO_SIDED|0.0|||||Fisher Exact|||||||0.04
72336196|NCT01007123|144195821|SUPERIORITY_OR_OTHER|||||||0.44|TWO_SIDED|0.0|||||ANCOVA|||||||0.44
72336197|NCT01007123|144195821|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|0.0|||||ANCOVA|||||||<0.001
72336198|NCT01007123|144195821|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|0.0|||||ANCOVA|||||||<0.001
72336199|NCT01007123|144195822|SUPERIORITY_OR_OTHER|||||||0.01|TWO_SIDED|0.0|||||ANCOVA|||Comparison vs placebo||||0.01
72336200|NCT01007123|144195822|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|0.0|||||ANCOVA|||Comparison vs placebo||||<0.05
72336201|NCT01007123|144195823|SUPERIORITY_OR_OTHER|||||||0.17|TWO_SIDED|0.0|||||ANCOVA|||||||0.17
72336202|NCT01007123|144195823|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|0.0|||||ANCOVA|||||||<0.001
72336203|NCT01007123|144195823|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|0.0|||||ANCOVA|||||||<0.001
72336204|NCT02075047|144195824|SUPERIORITY||Difference in least square (LS) mean|-4.23|STANDARD_ERROR_OF_MEAN|1.47||0.005|TWO_SIDED|95.0|-7.14|-1.32|||Mixed Models Analysis|||Change at Week 4: Results were obtained from a mixed effects repeated measures analysis of covariance model treatment, visit, visit-by-treatment interaction, and weight category as fixed effects and baseline score as a covariate along with participant as a random effect.||-1.32|-7.14|0.005
72336205|NCT02075047|144195825|SUPERIORITY||Difference in LS mean|-0.45|STANDARD_ERROR_OF_MEAN|0.13|<|0.001|TWO_SIDED|95.0|-0.69|-0.2|||Mixed Models Analysis|||Change at Week 1: Results were obtained from a mixed effects repeated measures analysis of covariance model treatment, visit, visit-by-treatment interaction, and weight category as fixed effects and baseline score as a covariate along with participant as a random effect.||-0.20|-0.69|<0.001
72336206|NCT02075047|144195825|SUPERIORITY||Difference in LS mean|-0.22|STANDARD_ERROR_OF_MEAN|0.16||0.174|TWO_SIDED|95.0|-0.53|0.1|||Mixed Models Analysis|||Change at Week 2: Results were obtained from a mixed effects repeated measures analysis of covariance model treatment, visit, visit-by-treatment interaction, and weight category as fixed effects and baseline score as a covariate along with participant as a random effect.||0.10|-0.53|0.174
72336207|NCT02075047|144195825|SUPERIORITY||Difference in LS mean|-0.38|STANDARD_ERROR_OF_MEAN|0.17||0.024|TWO_SIDED|95.0|-0.71|-0.05|||Mixed Models Analysis|||Change at Week 3: Results were obtained from a mixed effects repeated measures analysis of covariance model treatment, visit, visit-by-treatment interaction, and weight category as fixed effects and baseline score as a covariate along with participant as a random effect.||-0.05|-0.71|0.024
72336208|NCT02075047|144195825|SUPERIORITY||Difference in LS mean|-0.28|STANDARD_ERROR_OF_MEAN|0.19||0.138|TWO_SIDED|95.0|-0.64|0.09|||Mixed Models Analysis|||Change at Week 4: Results were obtained from a mixed effects repeated measures analysis of covariance model treatment, visit, visit-by-treatment interaction, and weight category as fixed effects and baseline score as a covariate along with participant as a random effect.||0.09|-0.64|0.138
72336209|NCT02075047|144195826|SUPERIORITY||Difference in LS mean|-5.85|STANDARD_ERROR_OF_MEAN|1.17|<|0.001|TWO_SIDED|95.0|-8.16|-3.54|||Mixed Models Analysis|||Change at Week 1: Results were obtained from a mixed effects repeated measures analysis of covariance model treatment, visit, visit-by-treatment interaction, and weight category as fixed effects and baseline score as a covariate along with participant as a random effect.||-3.54|-8.16|<0.001
72336210|NCT02075047|144195826|SUPERIORITY||Difference in LS mean|-4.17|STANDARD_ERROR_OF_MEAN|1.3||0.002|TWO_SIDED|95.0|-6.74|-1.59|||Mixed Models Analysis|||Change at Week 2: Results were obtained from a mixed effects repeated measures analysis of covariance model treatment, visit, visit-by-treatment interaction, and weight category as fixed effects and baseline score as a covariate along with participant as a random effect.||-1.59|-6.74|0.002
72336211|NCT02075047|144195826|SUPERIORITY||Difference in LS mean|-5.63|STANDARD_ERROR_OF_MEAN|1.31|<|0.001|TWO_SIDED|95.0|-8.21|-3.04|||Mixed Models Analysis|||Change at Week 3: Results were obtained from a mixed effects repeated measures analysis of covariance model treatment, visit, visit-by-treatment interaction, and weight category as fixed effects and baseline score as a covariate along with participant as a random effect.||-3.04|-8.21|<0.001
72336212|NCT02075047|144195827|SUPERIORITY||Difference in LS mean|-0.52|STANDARD_ERROR_OF_MEAN|0.13||0.001|TWO_SIDED|95.0|-0.78|-0.26|||Mixed Models Analysis|||Change at Week 1: Results were obtained from a mixed effects repeated measures analysis of covariance model treatment, visit, visit-by-treatment interaction, and weight category as fixed effects along with participant as a random effect.||-0.26|-0.78|0.001
72336213|NCT02075047|144195827|SUPERIORITY||Difference in LS mean|-0.15|STANDARD_ERROR_OF_MEAN|0.15||0.349|TWO_SIDED|95.0|-0.45|0.16|||Mixed Models Analysis|||Change at Week 2: Results were obtained from a mixed effects repeated measures analysis of covariance model treatment, visit, visit-by-treatment interaction, and weight category as fixed effects along with participant as a random effect.||0.16|-0.45|0.349
72369656|NCT05407064|144249698|SUPERIORITY|||||||0.0492|||||||t-test, 2 sided|||Change from baseline in total CGI-S scores determined by the difference in means and difference between treatment and placebo (p-value determined from two-sample t-test).||||0.0492
72426917|NCT00708305|144366004|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.07|||<|0.0001|TWO_SIDED|95.0|0.04|0.1||No adjustments for multiple comparisons were made as the primary comparison was pre-defined.|Wilcoxon Signed Rank Test||Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments, being compared. Statistical tests were 2-sided at 5% significance level.||0.10|0.04|<0.0001
72426918|NCT00708305|144366005|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.01||||0.4309|TWO_SIDED|95.0|-0.03|0.01||No adjustments for multiple comparisons were made as the primary comparison was pre-defined.|Wilcoxon Signed Rank Test||Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments, being compared. Statistical tests were 2-sided at 5% significance level.||0.01|-0.03|0.4309
72426919|NCT00708305|144366005|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.02||||0.0726|TWO_SIDED|95.0|0.0|0.04||No adjustments for multiple comparisons were made as the primary comparison was pre-defined.|Wilcoxon Signed Rank Test||Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments, being compared. Statistical tests were 2-sided at 5% significance level.||0.04|0.00|0.0726
72426920|NCT00708305|144366005|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.04|||<|0.0001|TWO_SIDED|95.0|0.03|0.06||No adjustments for multiple comparisons were made as the primary comparison was pre-defined.|Wilcoxon Signed Rank Test||Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments, being compared. Statistical tests were 2-sided at 5% significance level.||0.06|0.03|<0.0001
72426921|NCT00708305|144366005|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.03||||0.0107|TWO_SIDED|95.0|0.01|0.06||No adjustments for multiple comparisons were made as the primary comparison was pre-defined.|Wilcoxon Signed Rank Test||Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments, being compared. Statistical tests were 2-sided at 5% significance level.||0.06|0.01|0.0107
72426922|NCT00708305|144366005|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.05|||<|0.0001|TWO_SIDED|95.0|0.03|0.07|||Wilcoxon Signed Rank Test|No adjustments for multiple comparisons were made as the primary comparison was pre-defined.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments, being compared. Statistical tests were 2-sided at 5% significance level.||0.07|0.03|<0.0001
72426923|NCT00708305|144366005|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.03||||0.0012|TWO_SIDED|95.0|0.01|0.04||No adjustments for multiple comparisons were made as the primary comparison was pre-defined.|Wilcoxon Signed Rank Test||Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments, being compared. Statistical tests were 2-sided at 5% significance level.||0.04|0.01|0.0012
72336214|NCT02075047|144195827|SUPERIORITY||Difference in LS mean|-0.26|STANDARD_ERROR_OF_MEAN|0.16||0.103|TWO_SIDED|95.0|-0.57|0.05|||Mixed Models Analysis|||Change at Week 3: Results were obtained from a mixed effects repeated measures analysis of covariance model treatment, visit, visit-by-treatment interaction, and weight category as fixed effects along with participant as a random effect.||0.05|-0.57|0.103
72426924|NCT04711460|144366006|SUPERIORITY|Threshold of statistically significance was set at p=0.05. No power calculation was conducted.|Mean Difference (Final Values)|0.003|STANDARD_DEVIATION|5.59||0.003|TWO_SIDED|0.05||||Threshold of statistically significance was set at p=0.05. No power calculation was conducted.|t-test, 2 sided|Threshold of statistically significance was set at p=0.05. No power calculation was conducted.||||||0.003
72426925|NCT04711460|144366006|SUPERIORITY|The threshold for statistical significance was set at p=0.05. No power analysis was conducted.|Mean Difference (Final Values)|0.009|STANDARD_DEVIATION|5.59||0.009|ONE_SIDED|95.0||||Threshold of statistically significance was set at p=0.05. No power calculation was conducted.|ANOVA|Threshold of statistically significance was set at p=0.05. No power calculation was conducted.|Threshold of statistically significance was set at p=0.05. No power calculation was conducted.|||||0.009
72426926|NCT04711460|144366006|SUPERIORITY|The Tukey Kramer Post Hoc Test q value = 0.05 threshold|Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.609|<|0.05|TWO_SIDED|0.05||||Threshold of statistically significance was set at p=0.05. No power calculation was conducted.|Tukey Kramer Post-Hoc|Threshold of statistically significance was set at p=0.05.|Threshold of statistically significance was set at p=0.05. No power calculation was conducted.|||||<0.05
72426927|NCT04711460|144366006|SUPERIORITY|Threshold of statistically significance was set at p=0.05. No power calculation was conducted.|Mean Difference (Final Values)|0.05|STANDARD_DEVIATION|5.13||0.003|TWO_SIDED|0.05||||Threshold of statistically significance was set at p=0.05. No power calculation was conducted.|t-test, 2 sided|Threshold of statistically significance was set at p=0.05. No power calculation was conducted.|Threshold of statistically significance was set at p=0.05. No power calculation was conducted.|Threshold of statistically significance was set at p=0.05. No power calculation was conducted.||||0.003
72426928|NCT04711460|144366006|SUPERIORITY||Mean Difference (Final Values)|0.05|STANDARD_DEVIATION|5.07||0.454|ONE_SIDED|0.05||||Threshold of statistically significance was set at p=0.05. No power calculation was conducted.|ANOVA|Threshold of statistically significance was set at p=0.05. No power calculation was conducted.|Threshold of statistically significance was set at p=0.05. No power calculation was conducted.|Threshold of statistically significance was set at p=0.05. No power calculation was conducted.||||0.454
72426929|NCT04711460|144366007|SUPERIORITY|Threshold of statistically significance was set at p=0.05. No power calculation was conducted.|Mean Difference (Final Values)|0.05|STANDARD_DEVIATION|7.194||0.002|TWO_SIDED|0.05||||Threshold of statistically significance was set at p=0.05. No power calculation was conducted.|t-test, 2 sided|Threshold of statistically significance was set at p=0.05. No power calculation was conducted.|Threshold of statistically significance was set at p=0.05. No power calculation was conducted.|||||0.002
72426930|NCT04711460|144366007|SUPERIORITY||Mean Difference (Final Values)|0.05|STANDARD_DEVIATION|6.09||0.054|ONE_SIDED|0.05||||Threshold of statistically significance was set at p=0.05. No power calculation was conducted.|ANOVA|Threshold of statistically significance was set at p=0.05. No power calculation was conducted.|Threshold of statistically significance was set at p=0.05. No power calculation was conducted.|Threshold of statistically significance was set at p=0.05. No power calculation was conducted.||||0.054
72426931|NCT04711460|144366007|SUPERIORITY|Threshold of statistically significance was set at p=0.05. No power calculation was conducted.|Mean Difference (Final Values)|0.05|STANDARD_DEVIATION|6.93||0.019|TWO_SIDED|0.05||||Threshold of statistically significance was set at p=0.05. No power calculation was conducted.|t-test, 2 sided|Threshold of statistically significance was set at p=0.05. No power calculation was conducted.|Threshold of statistically significance was set at p=0.05. No power calculation was conducted.|Threshold of statistically significance was set at p=0.05. No power calculation was conducted.||||0.019
72426932|NCT04711460|144366007|SUPERIORITY|Threshold of statistically significance was set at p=0.05. No power calculation was conducted.|Mean Difference (Final Values)|0.05|STANDARD_DEVIATION|6.04||0.101|ONE_SIDED|95.0||||Threshold of statistically significance was set at p=0.05. No power calculation was conducted.|ANOVA|Threshold of statistically significance was set at p=0.05. No power calculation was conducted.||Threshold of statistically significance was set at p=0.05. No power calculation was conducted.||||0.101
72426933|NCT02771210|144366010|SUPERIORITY||Odds Ratio (OR)|1.63||||0.136|TWO_SIDED|95.0|0.87|3.08|||Regression, Logistic|||||3.08|0.87|0.136
72426934|NCT04397523|144366032|OTHER|||||||0.05||||||p=0.00000|ANOVA|df 2||||||0.05
72426935|NCT04397523|144366037|OTHER|||||||0.05||||||Chi- square = 24.98174, p = 0.00000|Chi-squared|df = 2||Overall survival between the three WHO score groups 3, 4 and 5||||0.05
72426936|NCT04397523|144366037|OTHER|||||||0.05||||||p=0.000|Chi-squared|df = 2||Correlation of mortality versus WHO disease progression score of patients||||0.05
72426937|NCT04397523|144366037|OTHER|||||||0.05||||||p = 0.000|Chi-squared|df = 1||Correlation of mortality versus stay in the intensive care unit (ICU)||||0.05
72336215|NCT02075047|144195827|SUPERIORITY||Difference in LS mean|-0.35|STANDARD_ERROR_OF_MEAN|0.17||0.044|TWO_SIDED|95.0|-0.68|-0.01|||Mixed Models Analysis|||Change at Week 4: Results were obtained from a mixed effects repeated measures analysis of covariance model treatment, visit, visit-by-treatment interaction, and weight category as fixed effects along with participant as a random effect.||-0.01|-0.68|0.044
72426938|NCT01275196|144366038|NON_INFERIORITY_OR_EQUIVALENCE|This trial was powered to detect an odds ratio of at least 2.333 which corresponds, for example, to increases of 18% (from 22% to 40%) and increases of 20% (from 30% to 50%).||||||0.0001|||||||Cochran-Mantel-Haenszel|||||||0.0001
72426939|NCT02572817|144366060|SUPERIORITY||Odds Ratio (OR)|1.22||||0.54|TWO_SIDED|95.0|0.65|2.29|||Regression, Logistic|||||2.29|0.65|0.54
72426940|NCT02572817|144366061|SUPERIORITY||Odds Ratio (OR)|0.86||||0.66|TWO_SIDED|95.0|0.45|1.66|||Regression, Logistic|||||1.66|0.45|0.66
72426941|NCT02572817|144366062|SUPERIORITY||Odds Ratio (OR)|0.95||||0.87|TWO_SIDED|95.0|0.5|1.8|||Regression, Logistic|||||1.8|0.5|0.87
72426942|NCT02572817|144366063|SUPERIORITY||Odds Ratio (OR)|1.26||||0.49|TWO_SIDED|95.0|0.65|2.41|||Regression, Logistic|||||2.41|0.65|0.49
72426943|NCT02572817|144366064|SUPERIORITY||Odds Ratio (OR)|1.07||||0.83|TWO_SIDED|95.0|0.55|2.08|||Regression, Logistic|||||2.08|0.55|0.83
72426944|NCT02572817|144366065|SUPERIORITY||Odds Ratio (OR)|1.29||||0.47|TWO_SIDED|95.0|0.65|2.56|||Regression, Logistic|||||2.56|0.65|0.47
72426945|NCT02572817|144366066|SUPERIORITY|||||||0.3|||||||Wilcoxon (Mann-Whitney)|||||||0.3
72426946|NCT02572817|144366067|SUPERIORITY||Hazard Ratio (HR)|0.74||||0.64|TWO_SIDED|95.0|0.21|2.64|||Log Rank|||||2.64|0.21|0.64
72426947|NCT02572817|144366068|SUPERIORITY|||||||0.69|||||||Fisher Exact|||||||0.69
72426948|NCT02572817|144366069|SUPERIORITY||Odds Ratio (OR)|1.33||||0.43|TWO_SIDED|95.0|0.65|2.71|||Regression, Logistic|||Composite mortality and hospitalization, Day 7||2.71|0.65|0.43
72426949|NCT02572817|144366069|SUPERIORITY||Odds Ratio (OR)|1.11||||0.79|TWO_SIDED|95.0|0.5|2.48|||Regression, Logistic|||Composite mortality and hospitalization, Day 14||2.48|0.5|0.79
72426950|NCT02572817|144366069|SUPERIORITY||Odds Ratio (OR)|1.65||||0.29|TWO_SIDED|95.0|0.66|4.12|||Regression, Logistic|||Composite mortality and hospitalization, Day 28||4.12|0.66|0.29
72426951|NCT02572817|144366070|SUPERIORITY||Hodges-Lehman estimate of location shift|-1.0||||0.2|TWO_SIDED|95.0|-2.0|0.0|||Wilcoxon (Mann-Whitney)|||Change in NEW from baseline to Day 3||0|-2|0.2
72426952|NCT02572817|144366070|SUPERIORITY||Hodges-Lehman estimate of location shift|0.0||||0.66|TWO_SIDED|95.0|-1.0|1.0|||Wilcoxon (Mann-Whitney)|||Change in NEW from baseline to Day 3||1|-1|0.66
72426953|NCT02572817|144366071|SUPERIORITY|||||||0.18|||||||Wilcoxon (Mann-Whitney)|||Change in PEW from baseline to Day 3||||0.18
72426954|NCT02572817|144366071|SUPERIORITY|||||||0.61|||||||Wilcoxon (Mann-Whitney)|||Change in PEW from baseline to Day 7||||0.61
72426955|NCT02572817|144366072|SUPERIORITY||Hodges-Lehman estimate of location shift|0.0||||0.68|TWO_SIDED|95.0|-2.0|1.0|||Wilcoxon (Mann-Whitney)|||||1|-2|0.68
72426956|NCT02572817|144366073|SUPERIORITY||Odds Ratio (OR)|1.42||||0.98|TWO_SIDED|95.0|0.23|11.01|||Regression, Logistic|||||11.01|0.23|0.98
72426957|NCT02572817|144366074|SUPERIORITY||Hodges-Lehman estimate of location shift|-1.5||||0.37|TWO_SIDED|95.0|-6.0|2.0|||Wilcoxon (Mann-Whitney)|||||2|-6|0.37
72426958|NCT02572817|144366075|SUPERIORITY|||||||0.55|||||||Fisher Exact|||||||0.55
72426959|NCT02572817|144366076|SUPERIORITY||Hodges-Lehman estimate of location shift|-3.0||||0.22|TWO_SIDED|95.0|-14.0|2.0|||Wilcoxon (Mann-Whitney)|||||2|-14|0.22
72426960|NCT02572817|144366077|SUPERIORITY||Odds Ratio (OR)|0.74||||1|TWO_SIDED|95.0|0.08|9.29|||Regression, Logistic|||||9.29|0.08|1
72426961|NCT02572817|144366079|SUPERIORITY||Odds Ratio (OR)|0.33||||0.24|TWO_SIDED|95.0|0.05|1.79|||Regression, Logistic|||||1.79|0.05|0.24
72426962|NCT02572817|144366081|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1
72426963|NCT02572817|144366082|SUPERIORITY||Hodges-Lehman estimate of location shift|0.0||||0.06|TWO_SIDED|95.0|-1.0|0.0|||Wilcoxon (Mann-Whitney)|||Change in SOFA from baseline to Day 3||0|-1|0.06
72426964|NCT02572817|144366082|SUPERIORITY||Hodges-Lehman estimate of location shift|-1.0||||0.13|TWO_SIDED|95.0|-1.0|0.0|||Wilcoxon (Mann-Whitney)|||Change in SOFA from baseline to Day 7||0|-1|0.13
72426965|NCT02572817|144366083|SUPERIORITY|||||||0.36|||||||Wilcoxon (Mann-Whitney)|||Change in PELOD from baseline to Day 3||||0.36
72426966|NCT02572817|144366083|SUPERIORITY|||||||0.15|||||||Wilcoxon (Mann-Whitney)|||Change in PELOD from baseline to Day 7||||0.15
72426967|NCT02572817|144366084|SUPERIORITY||Odds Ratio (OR)|1.73||||0.12|TWO_SIDED|95.0|0.87|3.44|||Regression, Logistic|||||3.44|0.87|0.12
72426968|NCT02572817|144366085|SUPERIORITY||Odds Ratio (OR)|0.47||||0.23|TWO_SIDED|95.0|0.13|1.43|||Regression, Logistic|||||1.43|0.13|0.23
72426969|NCT02441946|144366096|SUPERIORITY||Ratio of Geometric Means|0.19|||<|0.001|TWO_SIDED|90.0|0.13|0.28|||t-test, 1 sided|||||0.28|0.13|<0.001
72426970|NCT02441946|144366096|SUPERIORITY||Ratio of Geometric Means|0.25|||<|0.001|TWO_SIDED|90.0|0.17|0.38|||t-test, 1 sided|||||0.38|0.17|<0.001
72426971|NCT02761629|144366106|SUPERIORITY_OR_OTHER||Difference in Response Rates|12.7||||0.0536|TWO_SIDED|95.0|-0.01|26.6|||Fisher Exact||Exact 95% confidence interval was from the binomial distribution for response rate.|||26.6|-0.01|0.0536
72426972|NCT02761629|144366109|SUPERIORITY_OR_OTHER|||||||0.0175|||||||Fisher Exact|||||||0.0175
72426973|NCT02001974|144366121|OTHER|||||||0.0341|||||||ANOVA|||DF1681Y Cmax at Day -3||||0.0341
72426974|NCT02001974|144366121|OTHER|||||||0.0636|||||||ANOVA|||DF1681Y Cmax at Day -3||||0.0636
72426975|NCT02001974|144366121|OTHER|||||||0.0487|||||||ANOVA|||DF1681Y Cmax at Day 1||||0.0487
72426976|NCT02001974|144366121|OTHER|||||||0.3498|||||||ANOVA|||DF1681Y Cmax at Day 1||||0.3498
72336216|NCT02075047|144195841|SUPERIORITY||Difference in LS mean|0.1|STANDARD_ERROR_OF_MEAN|0.05||0.05|TWO_SIDED|95.0|0.0|0.2|||Mixed Models Analysis|||Change at Week 1: Results were obtained from a mixed effects repeated measures analysis of covariance model treatment, visit, visit-by-treatment interaction, and weight category as fixed effects and baseline score as a covariate along with participant as a random effect.||0.20|0.00|0.050
72336217|NCT02075047|144195841|SUPERIORITY||Difference in LS mean|0.11|STANDARD_ERROR_OF_MEAN|0.07||0.124|TWO_SIDED|95.0|-0.03|0.25|||Mixed Models Analysis|||Change at Week 2: Results were obtained from a mixed effects repeated measures analysis of covariance model treatment, visit, visit-by-treatment interaction, and weight category as fixed effects and baseline score as a covariate along with participant as a random effect.||0.25|-0.03|0.124
72426977|NCT02001974|144366121|OTHER|||||||0.0096|||||||ANOVA|||DF1681Y Cmax at Day 8||||0.0096
72426978|NCT02001974|144366121|OTHER|||||||0.1374|||||||ANOVA|||DF1681Y Cmax at Day 8||||0.1374
72426979|NCT02001974|144366121|OTHER|||||||0.0065|||||||ANOVA|||DF1681Y Cmax at Day 21||||0.0065
72426980|NCT02001974|144366121|OTHER|||||||0.147|||||||ANOVA|||DF1681Y Cmax at Day 21||||0.1470
72426981|NCT02001974|144366122|OTHER|||||||0.0015|||||||ANOVA|||DF2243 Cmax at Day -3||||0.0015
72426982|NCT02001974|144366122|OTHER|||||||0.0176|||||||ANOVA|||DF2243 Cmax at Day -3||||0.0176
72426983|NCT02001974|144366122|OTHER|||||||0.0048|||||||ANOVA|||DF2243 Cmax at Day 1||||0.0048
72426984|NCT02001974|144366122|OTHER|||||||0.2083|||||||ANOVA|||DF2243 Cmax at Day 1||||0.2083
72426985|NCT02001974|144366122|OTHER|||||||0.0111|||||||ANOVA|||DF2243 Cmax at Day 8||||0.0111
72426986|NCT02001974|144366122|OTHER|||||||0.1441|||||||ANOVA|||DF2243 Cmax at Day 8||||0.1441
72426987|NCT02001974|144366122|OTHER|||||||0.0283|||||||ANOVA|||DF2243 Cmax at Day 21||||0.0283
72426988|NCT02001974|144366122|OTHER|||||||0.1331|||||||ANOVA|||DF2243 Cmax at Day 21||||0.1331
72426989|NCT02001974|144366123|OTHER|||||||0.0097|||||||ANOVA|||DF2188Y, Cmax, Day -3||||0.0097
72426990|NCT02001974|144366123|OTHER|||||||0.0354|||||||ANOVA|||DF2188Y, Cmax, Day -3||||0.0354
72426991|NCT02001974|144366123|OTHER|||||||0.02|||||||ANOVA|||DF2188Y, Cmax, Day 1||||0.0200
72426992|NCT02001974|144366123|OTHER|||||||0.2134|||||||ANOVA|||DF2188Y, Cmax, Day 1||||0.2134
72426993|NCT02001974|144366123|OTHER|||||||0.0235|||||||ANOVA|||DF2188Y, Cmax, Day 8||||0.0235
72426994|NCT02001974|144366123|OTHER|||||||0.0964|||||||ANOVA|||DF2188Y, Cmax, Day 8||||0.0964
72426995|NCT02001974|144366123|OTHER|||||||0.0314|||||||ANOVA|||DF2188Y, Cmax, Day 21||||0.0314
72426996|NCT02001974|144366123|OTHER|||||||0.0773|||||||ANOVA|||DF2188Y, Cmax, Day 21||||0.0773
72426997|NCT02001974|144366124|OTHER|||||||0.1016|||||||ANOVA|||Cmax, ibuprofen, Day -3||||0.1016
72426998|NCT02001974|144366124|OTHER|||||||0.2001|||||||ANOVA|||Cmax, ibuprofen, Day -3||||0.2001
72426999|NCT02001974|144366124|OTHER|||||||0.0802|||||||ANOVA|||Cmax, ibuprofen, Day 1||||0.0802
72427000|NCT02001974|144366124|OTHER|||||||0.4728|||||||ANOVA|||Cmax, ibuprofen, Day 1||||0.4728
72427001|NCT02001974|144366124|OTHER|||||||0.0355|||||||ANOVA|||Cmax, ibuprofen, Day 8||||0.0355
72427002|NCT02001974|144366124|OTHER|||||||0.1709|||||||ANOVA|||Cmax, ibuprofen, Day 8||||0.1709
72427003|NCT02001974|144366124|OTHER|||||||0.0685|||||||ANOVA|||Cmax, ibuprofen, Day 21||||0.0685
72427004|NCT02001974|144366124|OTHER|||||||0.3189|||||||ANOVA|||Cmax, ibuprofen, Day 21||||0.3189
72427005|NCT02001974|144366125|OTHER|||||||0.2375|||||||ANOVA|||Paclitaxel, Cmax, Day 1||||0.2375
72427006|NCT02001974|144366125|OTHER|||||||0.3608|||||||ANOVA|||Cmax, ibuprofen, Day 1||||0.3608
72427007|NCT02001974|144366125|OTHER|||||||0.0442|||||||ANOVA|||Cmax, ibuprofen, Day 8||||0.0442
72427008|NCT02001974|144366125|OTHER|||||||0.1067|||||||ANOVA|||Cmax, ibuprofen, Day 8||||0.1067
72427009|NCT02001974|144366131|OTHER|||||||0.0134|||||||ANOVA|||DF1681Y, AUC0-8, Day -3||||0.0134
72427010|NCT02001974|144366131|OTHER|||||||0.0799|||||||ANOVA|||DF1681Y, AUC0-8, Day -3||||0.0799
72427011|NCT02001974|144366131|OTHER|||||||0.0241|||||||ANOVA|||DF1681Y, AUC0-8, Day 1||||0.0241
72427012|NCT02001974|144366131|OTHER|||||||0.01384|||||||ANOVA|||DF1681Y, AUC0-8, Day 1||||0.01384
72427013|NCT02001974|144366131|OTHER|||||||0.0091|||||||ANOVA|||DF1681Y, AUC0-8, Day 8||||0.0091
72427014|NCT02001974|144366131|OTHER|||||||0.5687|||||||ANOVA|||DF1681Y, AUC0-8, Day 8||||0.5687
72427015|NCT02001974|144366131|OTHER|||||||0.0058|||||||ANOVA|||DF1681Y, AUC0-8, Day 21||||0.0058
72427016|NCT02001974|144366131|OTHER|||||||0.3667|||||||ANOVA|||DF1681Y, AUC0-8, Day 21||||0.3667
72427017|NCT02001974|144366132|OTHER|||||||0.0029|||||||ANOVA|||DF2243Y - AUC0-8 - Day -3||||0.0029
72427018|NCT02001974|144366132|OTHER|||||||0.0349|||||||ANOVA|||DF2243Y - AUC0-8 - Day -3||||0.0349
72336218|NCT02075047|144195841|SUPERIORITY||Difference in LS mean|0.11|STANDARD_ERROR_OF_MEAN|0.06||0.084|TWO_SIDED|95.0|-0.01|0.23|||Mixed Models Analysis|||Change at Week 3: Results were obtained from a mixed effects repeated measures analysis of covariance model treatment, visit, visit-by-treatment interaction, and weight category as fixed effects and baseline score as a covariate along with participant as a random effect.||0.23|-0.01|0.084
72427019|NCT02001974|144366132|OTHER|||||||0.0119|||||||ANOVA|||DF2243Y - AUC0-8 - Day 1||||0.0119
72427020|NCT02001974|144366132|OTHER|||||||0.21|||||||ANOVA|||DF2243Y - AUC0-8 - Day 1||||0.2100
72427021|NCT02001974|144366132|OTHER|||||||0.0165|||||||ANOVA|||DF2243Y - AUC0-8 - Day 8||||0.0165
72427022|NCT02001974|144366132|OTHER|||||||0.1496|||||||ANOVA|||DF2243Y - AUC0-8 - Day 8||||0.1496
72427023|NCT02001974|144366132|OTHER|||||||0.0321|||||||ANOVA|||DF2243Y - AUC0-8 - Day 21||||0.0321
72427024|NCT02001974|144366132|OTHER|||||||0.1404|||||||ANOVA|||DF2243Y - AUC0-8 - Day 21||||0.1404
72427025|NCT02001974|144366133|OTHER|||||||0.0081|||||||ANOVA|||AUC0-8 for DF2188Y, Day -3||||0.0081
72427026|NCT02001974|144366133|OTHER|||||||0.064|||||||ANOVA|||AUC0-8 for DF2188Y, Day -3||||0.0640
72427027|NCT02001974|144366133|OTHER|||||||0.0397|||||||ANOVA|||AUC0-8 for DF2188Y, Day 1||||0.0397
72427028|NCT02001974|144366133|OTHER|||||||0.1898|||||||ANOVA|||AUC0-8 for DF2188Y, Day 1||||0.1898
72427029|NCT02001974|144366133|OTHER|||||||0.025|||||||ANOVA|||AUC0-8 for DF2188Y, Day 8||||0.0250
72427030|NCT02001974|144366133|OTHER|||||||0.1605|||||||ANOVA|||AUC0-8 for DF2188Y, Day 8||||0.1605
72427031|NCT02001974|144366133|OTHER|||||||0.0786|||||||ANOVA|||AUC0-8 for DF2188Y, Day 21||||0.0786
72427032|NCT02001974|144366133|OTHER|||||||0.2652|||||||ANOVA|||AUC0-8 for DF2188Y, Day 21||||0.2652
72427033|NCT02001974|144366134|OTHER|||||||0.1335|||||||ANOVA|||Ibuprofen, AUC0-8, Day -3||||0.1335
72427034|NCT02001974|144366134|OTHER|||||||0.2658|||||||ANOVA|||Ibuprofen, AUC0-8, Day -3||||0.2658
72427035|NCT02001974|144366134|OTHER|||||||0.1063|||||||ANOVA|||Ibuprofen, AUC0-8, Day 1||||0.1063
72427036|NCT02001974|144366134|OTHER|||||||0.4959|||||||ANOVA|||Ibuprofen, AUC0-8, Day 1||||0.4959
72427037|NCT02001974|144366134|OTHER|||||||0.0452|||||||ANOVA|||Ibuprofen, AUC0-8, Day 8||||0.0452
72427038|NCT02001974|144366134|OTHER|||||||0.2223|||||||ANOVA|||Ibuprofen, AUC0-8, Day 8||||0.2223
72427039|NCT02001974|144366134|OTHER|||||||0.0737|||||||ANOVA|||Ibuprofen, AUC0-8, Day 21||||0.0737
72427040|NCT02001974|144366134|OTHER|||||||0.2804|||||||ANOVA|||Ibuprofen, AUC0-8, Day21||||0.2804
72427041|NCT02001974|144366135|OTHER|||||||0.1449|||||||ANOVA|||Paclitaxel, AUC0-8, Day 1||||0.1449
72427042|NCT02001974|144366135|OTHER|||||||0.1338|||||||ANOVA|||Ibuprofen, AUC0-8, Day 1||||0.1338
72427043|NCT02001974|144366135|OTHER|||||||0.0633|||||||ANOVA|||Ibuprofen, AUC0-8, Day 8||||0.0633
72427044|NCT02001974|144366135|OTHER|||||||0.6939|||||||ANOVA|||Ibuprofen, AUC0-8, Day 8||||0.6939
72427045|NCT00119262|144366169|SUPERIORITY_OR_OTHER|||||||0.12|TWO_SIDED|95.0|||||Fisher Exact|||||||0.12
72427046|NCT00119262|144366170|SUPERIORITY_OR_OTHER|||||||0.32||95.0|||||Fisher Exact|||||||0.32
72427047|NCT04844918|144366193|SUPERIORITY||LS Mean Difference|-16.1|||<|0.001|TWO_SIDED|95.0|-18.7|-13.5|||Mixed Models Analysis|||||-13.5|-18.7|<0.001
72427048|NCT04844918|144366193|SUPERIORITY||LS Mean Difference|-21.1|||<|0.001|TWO_SIDED|95.0|-23.6|-18.5|||Mixed Models Analysis|||||-18.5|-23.6|<0.001
72427049|NCT04844918|144366194|SUPERIORITY||Odds Ratio (OR)|119.65|||<|0.001|TWO_SIDED|95.0|29.06|492.67|||Mixed Models Analysis|||||492.67|29.06|<0.001
72427050|NCT04844918|144366194|SUPERIORITY||Odds Ratio (OR)|153.57|||<|0.001|TWO_SIDED|95.0|36.03|654.53|||Mixed Models Analysis|||||654.53|36.03|<0.001
72427051|NCT04844918|144366195|SUPERIORITY||Odds Ratio (OR)|24.26|||<|0.001|TWO_SIDED|95.0|8.62|68.28|||Regression, Logistic|||||68.28|8.62|<0.001
72427052|NCT04844918|144366195|SUPERIORITY||Odds Ratio (OR)|38.27|||<|0.001|TWO_SIDED|95.0|13.21|110.89|||Regression, Logistic|||||110.89|13.21|<0.001
72427053|NCT04844918|144366196|SUPERIORITY||LS Mean Difference|-15.0|||<|0.001|TWO_SIDED|95.0|-18.91|-11.09|||Mixed Models Analysis|||||-11.09|-18.91|<0.001
72427054|NCT04844918|144366196|SUPERIORITY||LS Mean Difference|-12.8|||<|0.001|TWO_SIDED|95.0|-16.56|-9.05|||Mixed Models Analysis|||||-9.05|-16.56|<0.001
72427055|NCT04844918|144366197|SUPERIORITY||LS Mean Difference|-55.76|||<|0.001|TWO_SIDED|95.0|-69.74|-41.77|||Mixed Models Analysis|||||-41.77|-69.74|<0.001
72427056|NCT04844918|144366197|SUPERIORITY||LS Mean Difference|-64.82|||<|0.001|TWO_SIDED|95.0|-78.2|-51.43|||Mixed Models Analysis|||||-51.43|-78.20|<0.001
72427057|NCT04844918|144366198|SUPERIORITY||LS Mean Difference|-40.7|||<|0.001|TWO_SIDED|95.0|-50.0|-29.7|||Mixed Models Analysis|||||-29.7|-50.0|<0.001
72427058|NCT04844918|144366198|SUPERIORITY||LS Mean Difference|-44.5|||<|0.001|TWO_SIDED|95.0|-52.7|-34.9|||Mixed Models Analysis|||||-34.9|-52.7|<0.001
72336219|NCT02075047|144195841|SUPERIORITY||Difference in LS mean|0.09|STANDARD_ERROR_OF_MEAN|0.05||0.104|TWO_SIDED|95.0|-0.02|0.2|||Mixed Models Analysis|||Change at Week 4: Results were obtained from a mixed effects repeated measures analysis of covariance model treatment, visit, visit-by-treatment interaction, and weight category as fixed effects and baseline score as a covariate along with participant as a random effect.||0.20|-0.02|0.104
72336220|NCT02075047|144195842|SUPERIORITY||Difference in LS mean|-0.02|STANDARD_ERROR_OF_MEAN|0.02||0.169|TWO_SIDED|95.0|-0.06|0.01|||Mixed Models Analysis|||Change at Week 1: Results were obtained from a mixed effects repeated measures analysis of covariance model treatment, visit, visit-by-treatment interaction, and weight category as fixed effects and baseline score as a covariate along with participant as a random effect.||0.01|-0.06|0.169
72336221|NCT02075047|144195842|SUPERIORITY||Difference in LS mean|-0.01|STANDARD_ERROR_OF_MEAN|0.05||0.893|TWO_SIDED|95.0|-0.1|0.08|||Mixed Models Analysis|||Change at Week 2: Results were obtained from a mixed effects repeated measures analysis of covariance model treatment, visit, visit-by-treatment interaction, and weight category as fixed effects and baseline score as a covariate along with participant as a random effect.||0.08|-0.10|0.893
72336222|NCT02075047|144195842|SUPERIORITY||Difference in LS mean|0.0|STANDARD_ERROR_OF_MEAN|0.02||0.915|TWO_SIDED|95.0|-0.04|0.04|||Mixed Models Analysis|||Change at Week 3: Results were obtained from a mixed effects repeated measures analysis of covariance model treatment, visit, visit-by-treatment interaction, and weight category as fixed effects and baseline score as a covariate along with participant as a random effect.||0.04|-0.04|0.915
72336223|NCT02075047|144195842|SUPERIORITY||Difference in LS mean|0.02|STANDARD_ERROR_OF_MEAN|0.01||0.289|TWO_SIDED|95.0|-0.01|0.04|||Mixed Models Analysis|||Change at Week 4: Results were obtained from a mixed effects repeated measures analysis of covariance model treatment, visit, visit-by-treatment interaction, and weight category as fixed effects and baseline score as a covariate along with participant as a random effect.||0.04|-0.01|0.289
72336224|NCT02075047|144195843|SUPERIORITY||Difference in LS mean|0.03|STANDARD_ERROR_OF_MEAN|0.02||0.145|TWO_SIDED|95.0|-0.01|0.06|||Mixed Models Analysis|||Change at Week 1: Results were obtained from a mixed effects repeated measures analysis of covariance model treatment, visit, visit-by-treatment interaction, and weight category as fixed effects and baseline score as a covariate along with participant as a random effect.||0.06|-0.01|0.145
72336225|NCT02075047|144195843|SUPERIORITY||Difference in LS mean|0.03|STANDARD_ERROR_OF_MEAN|0.02||0.148|TWO_SIDED|95.0|-0.01|0.07|||Mixed Models Analysis|||Change at Week 2: Results were obtained from a mixed effects repeated measures analysis of covariance model treatment, visit, visit-by-treatment interaction, and weight category as fixed effects and baseline score as a covariate along with participant as a random effect.||0.07|-0.01|0.148
72336226|NCT02075047|144195843|SUPERIORITY||Difference in LS mean|0.07|STANDARD_ERROR_OF_MEAN|0.04||0.082|TWO_SIDED|95.0|-0.01|0.15|||Mixed Models Analysis|||Change at Week 3: Results were obtained from a mixed effects repeated measures analysis of covariance model treatment, visit, visit-by-treatment interaction, and weight category as fixed effects and baseline score as a covariate along with participant as a random effect.||0.15|-0.01|0.082
72336227|NCT02075047|144195843|SUPERIORITY||Difference in LS mean|0.04|STANDARD_ERROR_OF_MEAN|0.02||0.07|TWO_SIDED|95.0|0.0|0.09|||Mixed Models Analysis|||Change at Week 4: Results were obtained from a mixed effects repeated measures analysis of covariance model treatment, visit, visit-by-treatment interaction, and weight category as fixed effects and baseline score as a covariate along with participant as a random effect.||0.09|-0.00|0.070
72336228|NCT00297102|144195847|SUPERIORITY_OR_OTHER||Mean Difference (Net)|39.0|STANDARD_ERROR_OF_MEAN|11.0||0.0003|TWO_SIDED|95.0|18.0|60.0||No adjustment of the significance level was done as a hierarchical approach for hypotheses testing was used.|ANCOVA|Repeated measurements analysis (change from baseline over 52 weeks of treatment taking all post-randomization measurements into account).||||60|18|0.0003
72336229|NCT00297102|144195848|SUPERIORITY_OR_OTHER||Rate ratio|0.851|STANDARD_ERROR_OF_MEAN|0.062||0.0278|TWO_SIDED|95.0|0.737|0.982||No adjustment of the significance level was done as a hierarchical approach for hypotheses testing was used.|Poisson regression|||||0.982|0.737|0.0278
72336230|NCT00297102|144195849|SUPERIORITY_OR_OTHER||Mean Difference (Net)|49.0|STANDARD_ERROR_OF_MEAN|11.0|<|0.0001|TWO_SIDED|95.0|26.0|71.0||No adjustment of the significance level was done as a hierarchical approach for hypotheses testing was used.|ANCOVA|Repeated measurements analysis (change from baseline over 52 weeks of treatment taking all post-randomization measurements into account).||||71|26|<0.0001
72336231|NCT00297102|144195850|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.035|STANDARD_ERROR_OF_MEAN|0.357||0.9212|TWO_SIDED|95.0|0.526|2.034||No adjustment of the significance level was done as a hierarchical approach for hypotheses testing was used.|Cox proportional hazards regression||The statistical analysis is based on the ITT Analysis Set (n= 765 in the roflumilast group, n= 758 in the placebo group).|||2.034|0.526|0.9212
72336232|NCT00297102|144195851|SUPERIORITY_OR_OTHER||Mean Difference calculated as ratio|0.9521||||0.4089|TWO_SIDED|95.0|0.8472|1.0699||No adjustment of the significance level was done as a hierarchical approach for hypotheses testing was used.|ANCOVA|ANCOVA model including last observation carried forward (LOCF) method||||1.0699|0.8472|0.4089
72369657|NCT05407064|144249698|SUPERIORITY|||||||0.0131|||||||t-test, 2 sided|||Change from baseline in total CGI-S scores determined by the difference in means and difference between treatment and placebo (p-value determined from two-sample t-test).||||0.0131
72427059|NCT04844918|144366199|SUPERIORITY||LS Mean Difference|-44.4|||<|0.001|TWO_SIDED|95.0|-53.0|-35.7|||ANCOVA|||||-35.7|-53.0|<0.001
72427060|NCT04844918|144366199|SUPERIORITY||LS Mean Difference|-50.4|||<|0.001|TWO_SIDED|95.0|-58.8|-41.9|||ANCOVA|||||-41.9|-58.8|<0.001
72427061|NCT04844918|144366200|SUPERIORITY||Odds Ratio (OR)|25.42|||<|0.001|TWO_SIDED|95.0|7.25|89.14|||Regression, Logistic|||||89.14|7.25|<0.001
72427062|NCT04844918|144366200|SUPERIORITY||Odds Ratio (OR)|70.66|||<|0.001|TWO_SIDED|95.0|12.73|392.24|||Regression, Logistic|||||392.24|12.73|<0.001
72427063|NCT04844918|144366201|SUPERIORITY||Odds Ratio (OR)|9.29|||<|0.001|TWO_SIDED|95.0|2.86|30.2|||Regression, Logistic|||||30.20|2.86|<0.001
72427064|NCT04844918|144366201|SUPERIORITY||Odds Ratio (OR)|15.67|||<|0.001|TWO_SIDED|95.0|4.78|51.37|||Regression, Logistic|||||51.37|4.78|<0.001
72427065|NCT04844918|144366202|SUPERIORITY||Odds Ratio (OR)|27.5|||<|0.001|TWO_SIDED|95.0|9.35|80.88|||Regression, Logistic|||||80.88|9.35|<0.001
72427066|NCT04844918|144366202|SUPERIORITY||Odds Ratio (OR)|40.01|||<|0.001|TWO_SIDED|95.0|13.27|120.57|||Regression, Logistic|||||120.57|13.27|<0.001
72427067|NCT04844918|144366203|SUPERIORITY||Odds Ratio (OR)|185.92|||<|0.001|TWO_SIDED|95.0|46.39|745.16|||Regression, Logistic|||||745.16|46.39|<0.001
72427068|NCT04844918|144366203|SUPERIORITY||Odds Ratio (OR)|318.02|||<|0.001|TWO_SIDED|95.0|74.49|1357.79|||Regression, Logistic|||||1357.79|74.49|<0.001
72336233|NCT00297102|144195852|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.233|STANDARD_ERROR_OF_MEAN|0.111||0.0356|TWO_SIDED|95.0|0.016|0.449||No adjustment of the significance level was done as a hierarchical approach for hypotheses testing was used.|ANCOVA|Repeated measurements analysis (change from baseline over 52 weeks of treatment taking all post-randomization measurements into account).||||0.449|0.016|0.0356
72427069|NCT04844918|144366204|SUPERIORITY||Odds Ratio (OR)|100.21|||<|0.001|TWO_SIDED|95.0|18.64|538.74|||Regression, Logistic|||||538.74|18.64|<0.001
72336234|NCT01774097|144195869|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.9|STANDARD_ERROR_OF_MEAN|0.8||0.238|TWO_SIDED|95.0|-0.6|2.5||Threshold 0.05; no adjustment for multiple comparisons per protocol.|t-test, 2 sided|||||2.5|-0.6|0.238
72427070|NCT04844918|144366204|SUPERIORITY||Odds Ratio (OR)|286.73|||<|0.001|TWO_SIDED|95.0|50.68|1622.06|||Regression, Logistic|||||1622.06|50.68|<0.001
72427071|NCT04844918|144366205|SUPERIORITY||LS Mean Difference|-14.5|||<|0.001|TWO_SIDED|95.0|-16.8|-12.2|||Mixed Models Analysis|||||-12.2|-16.8|<0.001
72427072|NCT04844918|144366205|SUPERIORITY||LS Mean Difference|-19.3|||<|0.001|TWO_SIDED|95.0|-21.6|-17.0|||Mixed Models Analysis|||||-17.0|-21.6|<0.001
72427073|NCT04844918|144366206|SUPERIORITY||LS Mean Difference|-5.2|||<|0.001|TWO_SIDED|95.0|-6.1|-4.4|||Mixed Models Analysis|||||-4.4|-6.1|<0.001
72427074|NCT04844918|144366206|SUPERIORITY||LS Mean Difference|-7.1|||<|0.001|TWO_SIDED|95.0|-8.0|-6.3|||Mixed Models Analysis|||||-6.3|-8.0|<0.001
72427075|NCT04844918|144366207|SUPERIORITY||LS Mean Difference|-36.1|||<|0.001|TWO_SIDED|95.0|-42.9|-29.3|||Mixed Models Analysis|||||-29.3|-42.9|<0.001
72427076|NCT04844918|144366207|SUPERIORITY||LS Mean Difference|-41.1|||<|0.001|TWO_SIDED|95.0|-47.8|-34.4|||Mixed Models Analysis|||||-34.4|-47.8|<0.001
72427077|NCT04844918|144366208|SUPERIORITY||LS Mean Difference|-27.2|||<|0.001|TWO_SIDED|95.0|-32.6|-21.9|||Mixed Models Analysis|||||-21.9|-32.6|<0.001
72427078|NCT04844918|144366208|SUPERIORITY||LS Mean Difference|-31.5|||<|0.001|TWO_SIDED|95.0|-36.7|-26.2|||Mixed Models Analysis|||||-26.2|-36.7|<0.001
72427079|NCT04844918|144366209|SUPERIORITY||LS Mean Difference|-0.1||||0.004|TWO_SIDED|95.0|-0.16|-0.03|||Mixed Models Analysis|||||-0.03|-0.16|0.004
72427080|NCT04844918|144366209|SUPERIORITY||LS Mean Difference|-0.09||||0.006|TWO_SIDED|95.0|-0.15|-0.03|||Mixed Models Analysis|||||-0.03|-0.15|0.006
72427081|NCT04844918|144366210|SUPERIORITY||Odds Ratio (OR)|28.52|||<|0.001|TWO_SIDED|95.0|4.31|188.55|||Regression, Logistic|||||188.55|4.31|<0.001
72427082|NCT04844918|144366210|SUPERIORITY||Odds Ratio (OR)|57.73|||<|0.001|TWO_SIDED|95.0|8.68|383.88|||Regression, Logistic|||||383.88|8.68|<0.001
72427083|NCT04844918|144366211|SUPERIORITY||LS Mean Difference|-11.4|||<|0.001|TWO_SIDED|95.0|-13.8|-9.0|||Mixed Models Analysis|||||-9.0|-13.8|<0.001
72427084|NCT04844918|144366211|SUPERIORITY||LS Mean Difference|-15.3|||<|0.001|TWO_SIDED|95.0|-17.7|-13.0|||Mixed Models Analysis|||||-13.0|-17.7|<0.001
72427085|NCT04844918|144366212|SUPERIORITY||LS Mean Difference|-0.65|||<|0.001|TWO_SIDED|95.0|-0.77|-0.53|||Mixed Models Analysis|||||-0.53|-0.77|<0.001
72427086|NCT04844918|144366212|SUPERIORITY||LS Mean Difference|-0.66|||<|0.001|TWO_SIDED|95.0|-0.77|-0.55|||Mixed Models Analysis|||||-0.55|-0.77|<0.001
72427087|NCT04844918|144366213|SUPERIORITY||LS Mean Difference|-3.91|||||TWO_SIDED|95.0|-5.74|-2.08||||||||-2.08|-5.74|
72427088|NCT04844918|144366213|SUPERIORITY||LS Mean Difference|-4.55|||||TWO_SIDED|95.0|-6.29|-2.81||||||||-2.81|-6.29|
72427089|NCT04844918|144366214|SUPERIORITY||LS Mean Difference|-13.2|||<|0.001|TWO_SIDED|95.0|-17.0|-9.3|||Mixed Models Analysis|||||-9.3|-17.0|<0.001
72427090|NCT04844918|144366214|SUPERIORITY||LS Mean Difference|-13.9|||<|0.001|TWO_SIDED|95.0|-17.7|-10.1|||Mixed Models Analysis|||||-10.1|-17.7|<0.001
72427091|NCT04844918|144366215|SUPERIORITY||LS Mean Difference|-6.3|||<|0.001|TWO_SIDED|95.0|-9.3|-3.4|||Mixed Models Analysis|||||-3.4|-9.3|<0.001
72427092|NCT04844918|144366215|SUPERIORITY||LS Mean Difference|-6.8|||<|0.001|TWO_SIDED|95.0|-9.7|-3.9|||Mixed Models Analysis|||||-3.9|-9.7|<0.001
72427093|NCT04844918|144366216|SUPERIORITY||LS Mean Difference|1.3||||0.022|TWO_SIDED|95.0|0.2|2.3|||ANCOVA|||||2.3|0.2|0.022
72427094|NCT04844918|144366216|SUPERIORITY||LS Mean Difference|2.1|||<|0.001|TWO_SIDED|95.0|1.1|3.2|||ANCOVA|||||3.2|1.1|<0.001
72427095|NCT04844918|144366217|SUPERIORITY||LS Mean Difference|13.0|||<|0.001|TWO_SIDED|95.0|7.4|18.7|||ANCOVA|||||18.7|7.4|<0.001
72427096|NCT04844918|144366217|SUPERIORITY||LS Mean Difference|10.8|||<|0.001|TWO_SIDED|95.0|5.4|16.3|||ANCOVA|||||16.3|5.4|<0.001
72427097|NCT04844918|144366218|SUPERIORITY||LS Mean Difference|0.03||||0.099|TWO_SIDED|95.0|0.0|0.06|||ANCOVA|||||0.06|0.00|0.099
72427098|NCT04844918|144366218|SUPERIORITY||LS Mean Difference|0.02||||0.236|TWO_SIDED|95.0|-0.01|0.05|||ANCOVA|||||0.05|-0.01|0.236
72427099|NCT05033080|144366243|NON_INFERIORITY|The non-inferiority margin represents a clinically acceptable loss of effectiveness that margin preserve at least 50% of the treatment effect of the active control (ELX/TEZ/IVA) compared to placebo, where the treatment effect is estimated by the lower bound of the 95% confidence interval (CI).|LS Mean difference|0.2|||<|0.0001|TWO_SIDED|95.0|-0.7|1.1|||Mixed Models Repeated Measures|||||1.1|-0.7|< 0.0001
72427100|NCT05033080|144366244|SUPERIORITY||LS Mean difference|-8.4|||<|0.0001|TWO_SIDED|95.0|-10.5|-6.3|||Mixed Models Repeated Measures|||||-6.3|-10.5|< 0.0001
72336235|NCT01774097|144195870|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.9|STANDARD_ERROR_OF_MEAN|0.6||0.116|TWO_SIDED|95.0|-0.2|2.1||Threshold 0.05; no adjustment for multiple comparisons per protocol.|t-test, 2 sided|||||2.1|-0.2|0.116
72336236|NCT01774097|144195871|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|0.4||0.978|TWO_SIDED|95.0|-0.8|0.8||Threshold 0.05; no adjustment for multiple comparisons per protocol.|t-test, 2 sided|||||0.8|-0.8|0.978
72427101|NCT05033080|144366245|OTHER||Odds Ratio (OR)|2.21|||<|0.0001|TWO_SIDED|95.0|1.55|3.15|||Generalized Estimated Equation Model|||||3.15|1.55|< 0.0001
72427102|NCT05033080|144366246|OTHER||Odds Ratio (OR)|2.87|||<|0.0001|TWO_SIDED|95.0|2.0|4.12|||Generalized Estimated Equation Model|||||4.12|2.00|< 0.0001
72427103|NCT01263106|144366247|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Means|1.12|||||TWO_SIDED|90.0|1.05|1.2|||Mixed Models Analysis|||||1.20|1.05|
72427104|NCT01263106|144366248|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Means|0.96|||||TWO_SIDED|90.0|0.92|1.01|||Mixed Models Analysis|||||1.01|0.92|
72427105|NCT01263106|144366249|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.8008|TWO_SIDED|90.0|-3.0|1.0|||Wilcoxon (Mann-Whitney)|||||1.00|-3.00|0.8008
72427106|NCT00405704|144366277|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Log Rank|||||||<0.001
72427107|NCT00405704|144366278|SUPERIORITY_OR_OTHER_LEGACY|||||||0.55|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.55
72427108|NCT00405704|144366279|SUPERIORITY_OR_OTHER_LEGACY|||||||0.37|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.37
72427109|NCT00405704|144366280|SUPERIORITY_OR_OTHER_LEGACY|||||||0.94|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.94
72427110|NCT00405704|144366281|SUPERIORITY_OR_OTHER_LEGACY|||||||0.04|TWO_SIDED||||||Log Rank|||||||0.04
72427111|NCT00405704|144366282|SUPERIORITY_OR_OTHER_LEGACY|||||||0.065|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.065
72427112|NCT00405704|144366283|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
72427113|NCT00405704|144366284|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
72427114|NCT03012061|144366285|SUPERIORITY||Mean Difference (Net)|0.1758|STANDARD_ERROR_OF_MEAN|0.0426|<|0.001|TWO_SIDED|95.0|0.092|0.2595|||Mixed-model repeated measures (MMRM)||UMEC 31.25 mcg versus placebo|||0.2595|0.0920|<0.001
72427115|NCT03012061|144366285|SUPERIORITY||Mean Difference (Net)|0.1841|STANDARD_ERROR_OF_MEAN|0.0424|<|0.001|TWO_SIDED|95.0|0.1008|0.2675|||MMRM||UMEC 62.5 mcg versus placebo|||0.2675|0.1008|<0.001
72427116|NCT03012061|144366286|SUPERIORITY||Mean Difference (Net)|0.1895|STANDARD_ERROR_OF_MEAN|0.0455|<|0.001|TWO_SIDED|95.0|0.1|0.2789||Analysis of covariance (ANCOVA)|ANCOVA||UMEC 31.25 mcg vs Placebo|||0.2789|0.1000|<0.001
72427117|NCT03012061|144366286|SUPERIORITY||Mean Difference (Net)|0.1976|STANDARD_ERROR_OF_MEAN|0.0453|<|0.001|TWO_SIDED|95.0|0.1086|0.2866|||ANCOVA||UMEC 62.5 mcg vs Placebo|||0.2866|0.1086|<0.001
72427118|NCT03012061|144366289|SUPERIORITY||Median Difference (Net)|1.7|STANDARD_ERROR_OF_MEAN|1.0||0.083|TWO_SIDED|95.0|-0.2|3.7|||MMRM||UMEC 31.25 mcg vs Placebo, SBP, Week 4|||3.7|-0.2|0.083
72427119|NCT03012061|144366289|SUPERIORITY||Median Difference (Net)|-0.5|STANDARD_ERROR_OF_MEAN|1.11||0.636|TWO_SIDED|95.0|-2.7|1.7|||MMRM||UMEC 31.25 mcg vs Placebo, SBP, Week 12|||1.7|-2.7|0.636
72427120|NCT03012061|144366289|SUPERIORITY||Mean Difference (Net)|1.7|STANDARD_ERROR_OF_MEAN|1.1||0.115|TWO_SIDED|95.0|-0.4|3.9|||MMRM||UMEC 31.25 mcg vs Placebo, SBP, Week 24|||3.9|-0.4|0.115
72427121|NCT03012061|144366289|SUPERIORITY||Mean Difference (Net)|1.0|STANDARD_ERROR_OF_MEAN|0.99||0.336|TWO_SIDED|95.0|-1.0|2.9|||MMRM||UMEC 62.5 mcg vs Placebo, SBP, Week 4|||2.9|-1.0|0.336
72427122|NCT03012061|144366289|SUPERIORITY||Mean Difference (Net)|0.3|STANDARD_ERROR_OF_MEAN|1.11||0.787|TWO_SIDED|95.0|-1.9|2.5|||MMRM||UMEC 62.5 mcg vs Placebo, SBP, Week 12|||2.5|-1.9|0.787
72427123|NCT03012061|144366289|SUPERIORITY||Mean Difference (Net)|0.5|STANDARD_ERROR_OF_MEAN|1.1||0.625|TWO_SIDED|95.0|-1.6|2.7|||MMRM||UMEC 62.5 mcg vs Placebo, SBP, Week 24|||2.7|-1.6|0.625
72427124|NCT03012061|144366289|SUPERIORITY||Mean Difference (Net)|0.8|STANDARD_ERROR_OF_MEAN|0.79||0.309|TWO_SIDED|95.0|-0.7|2.3|||MMRM||UMEC 31.25 mcg vs Placebo, DBP, Week 4|||2.3|-0.7|0.309
72427125|NCT03012061|144366289|SUPERIORITY||Mean Difference (Net)|-0.5|STANDARD_ERROR_OF_MEAN|0.82||0.521|TWO_SIDED|95.0|-2.1|1.1|||MMRM||UMEC 31.25 mcg vs Placebo, DBP, Week 12|||1.1|-2.1|0.521
72427126|NCT03012061|144366289|SUPERIORITY||Mean Difference (Net)|1.6|STANDARD_ERROR_OF_MEAN|0.81||0.047|TWO_SIDED|95.0|0.0|3.2|||MMRM||UMEC 31.25 mcg vs Placebo, DBP, Week 24|||3.2|0.0|0.047
72336237|NCT01774097|144195872|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.17|STANDARD_ERROR_OF_MEAN|0.55||0.752|TWO_SIDED|95.0|-1.26|0.91||Threshold 0.05; no adjustment for multiple comparisons per protocol.|t-test, 2 sided|||||0.91|-1.26|0.752
72336238|NCT01774097|144195873|SUPERIORITY_OR_OTHER||interaction term|0.0|STANDARD_ERROR_OF_MEAN|0.01||0.871|TWO_SIDED|95.0|-0.02|0.03||Threshold 0.05; no adjustment for multiple comparisons per protocol.|Regression, Linear|||||0.03|-0.02|0.871
72427127|NCT03012061|144366289|SUPERIORITY||Mean Difference (Net)|0.2|STANDARD_ERROR_OF_MEAN|0.78||0.779|TWO_SIDED|95.0|-1.3|1.8|||MMRM||UMEC 62.5 mcg versus placebo, DBP, Week 4|||1.8|-1.3|0.779
72427128|NCT03012061|144366289|SUPERIORITY||Mean Difference (Net)|1.0|STANDARD_ERROR_OF_MEAN|0.82||0.204|TWO_SIDED|95.0|-0.6|2.6|||MMRM||UMEC 62.5 mcg versus placebo, DBP, Week 12|||2.6|-0.6|0.204
72427129|NCT03012061|144366289|SUPERIORITY||Mean Difference (Net)|1.5|STANDARD_ERROR_OF_MEAN|0.81||0.066|TWO_SIDED|95.0|-0.1|3.1|||MMRM||UMEC 62.5 mcg versus placebo, DBP, Week 24|||3.1|-0.1|0.066
72427130|NCT03012061|144366290|SUPERIORITY||Mean Difference (Net)|1.3|STANDARD_ERROR_OF_MEAN|0.97||0.195|TWO_SIDED|95.0|-0.7|3.2|||MMRM||UMEC 31.25 mcg vs Placebo, Week 4|||3.2|-0.7|0.195
72427131|NCT03012061|144366290|SUPERIORITY||Mean Difference (Net)|0.6|STANDARD_ERROR_OF_MEAN|0.84||0.457|TWO_SIDED|95.0|-1.0|2.3|||MMRM||UMEC 31.25 mcg versus Placebo, Week 12|||2.3|-1.0|0.457
72427132|NCT03012061|144366290|SUPERIORITY||Mean Difference (Net)|1.1|STANDARD_ERROR_OF_MEAN|1.07||0.3|TWO_SIDED|95.0|-1.0|3.2|||MMRM||UMEC 31.25 mcg versus Placebo, Week 24|||3.2|-1.0|0.300
72427133|NCT03012061|144366290|SUPERIORITY||Mean Difference (Net)|1.4|STANDARD_ERROR_OF_MEAN|0.97||0.14|TWO_SIDED|95.0|-0.5|3.3|||MMRM||UMEC 62.5 mcg versus Placebo, Week 4|||3.3|-0.5|0.140
72427134|NCT03012061|144366290|SUPERIORITY||Mean Difference (Net)|1.7|STANDARD_ERROR_OF_MEAN|0.84||0.045|TWO_SIDED|95.0|0.0|3.3|||MMRM||UMEC 62.5 mcg versus Placebo, Week 12|||3.3|0.0|0.045
72427135|NCT03012061|144366290|SUPERIORITY||Mean Difference (Net)|3.4|STANDARD_ERROR_OF_MEAN|1.07||0.002|TWO_SIDED|95.0|1.3|5.5|||MMRM||UMEC 62.5 mcg versus Placebo, Week 24|||5.5|1.3|0.002
72427136|NCT02696902|144366291|SUPERIORITY||Relative risk reduction|-23.7||||0.491|TWO_SIDED|80.0|-83.8|16.8|||Poisson regression with robust variance|||||16.8|-83.8|0.491
72427137|NCT05822921|144366309|OTHER|Independent t-test was used.||||||0.871|||||||t-test, 2 sided|||||||.871
72427138|NCT05822921|144366310|OTHER|Independent t-test was used.||||||0.896|||||||t-test, 2 sided|||||||0.896
72427139|NCT05822921|144366311|OTHER|Independent t-test was used.||||||0.351|||||||t-test, 2 sided|||||||0.351
72427140|NCT00544544|144366313|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Mixed Models Analysis|||||||<.001
72427141|NCT00544544|144366314|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
72427142|NCT00544544|144366315|SUPERIORITY_OR_OTHER|||||||0.38|||||||Mixed Models Analysis|||||||0.38
72427143|NCT00544544|144366316|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
72427144|NCT01857622|144366407|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|3.8|||||TWO_SIDED|95.0|-14.7|26.8|||Wilcoxon (Mann-Whitney)|no statistical test||||26.8|-14.7|
72427145|NCT01857622|144366407|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|2.7|||||TWO_SIDED|95.0|-15.4|25.2|||Wilcoxon (Mann-Whitney)|||||25.2|-15.4|
72427146|NCT02855164|144366428|SUPERIORITY|Repeated measures analysis: ALT (U/L) change from baseline up to EOT (Parts A + B) (Full analysis set)|LS mean change|-15.9|STANDARD_ERROR_OF_MEAN|7.76||0.362|TWO_SIDED|95.0|-31.2|-0.6|||ANCOVA|||10 micrograms of Tropifexor vs placebo (Part A)||-0.6|-31.2|0.362
72427147|NCT02855164|144366428|SUPERIORITY|Repeated measures analysis: ALT (U/L) change from baseline up to EOT (Parts A + B) (Full analysis set)|LS mean change|-10.7|STANDARD_ERROR_OF_MEAN|7.12||0.729|TWO_SIDED|95.0|-24.8|3.3|||ANCOVA|||30 micrograms of Tropifexor vs placebo (Part A)||3.3|-24.8|0.729
72427148|NCT02855164|144366428|SUPERIORITY|Repeated measures analysis: ALT (U/L) change from baseline up to EOT (Parts A + B) (Full analysis set)|Least Square Mean Change|-16.5|STANDARD_ERROR_OF_MEAN|4.73||0.173|TWO_SIDED|95.0|-25.8|-7.1|||ANCOVA|||60 micrograms of Tropifexor vs placebo (Parts A + B)||-7.1|-25.8|0.173
72427149|NCT02855164|144366428|SUPERIORITY|Repeated measures analysis: ALT (U/L) change from baseline up to EOT (Parts A + B) (Full analysis set)|Least Square Mean Change|-14.9|STANDARD_ERROR_OF_MEAN|3.25||0.185|TWO_SIDED|95.0|-21.3|-8.5|||ANCOVA|||90 micrograms of Tropifexor vs placebo (Parts A + B)||-8.5|-21.3|0.185
72427150|NCT02855164|144366428|SUPERIORITY|Repeated measures analysis: ALT (U/L) change from baseline up to EOT (Part C) (Full analysis set)|LS Mean Change|-31.6|STANDARD_ERROR_OF_MEAN|7.71||0.02|TWO_SIDED|95.0|-46.9|-16.3|||ANCOVA|||140 micrograms of Tropifexor (Part C) vs placebo||-16.3|-46.9|0.020
72427151|NCT02855164|144366428|SUPERIORITY|Repeated measures analysis: ALT (U/L) change from baseline up to EOT (Part C) (Full analysis set)|LS Mean Change|-32.5|STANDARD_ERROR_OF_MEAN|9.1||0.03|TWO_SIDED|95.0|-50.6|-14.5|||ANCOVA|||200 micrograms of Tropifexor vs placebo (Part C)||-14.5|-50.6|0.030
72427152|NCT02855164|144366428|SUPERIORITY|Repeated measures analysis: ALT (U/L) change from baseline to Week 12 (Parts A+B+C) Full analysis set (FAS)|LS Mean change|-13.4|STANDARD_ERROR_OF_MEAN|7.86||0.456|TWO_SIDED|95.0|-26.3|-0.4|||ANCOVA|||10 micrograms of Tropifexor vs placebo (Parts A + B + C)||-0.4|-26.3|0.456
72427153|NCT02855164|144366428|SUPERIORITY|Repeated measures analysis: ALT (U/L) change from baseline to Week 12 (Parts A+B+C) Full analysis set (FAS)|LS Mean change|-7.5|STANDARD_ERROR_OF_MEAN|7.27||0.966|TWO_SIDED|95.0|-19.5|4.4|||ANCOVA|||30 micrograms of Tropifexor vs placebo (Parts A + B + C)||4.4|-19.5|0.966
72427154|NCT02855164|144366428|SUPERIORITY|Repeated measures analysis: ALT (U/L) change from baseline to Week 12 (Parts A+B+C) Full analysis set (FAS)|LS Mean change|-13.3|STANDARD_ERROR_OF_MEAN|4.93||0.275|TWO_SIDED|95.0|-21.4|-5.2|||ANCOVA|||60 micrograms of Tropifexor vs placebo (Parts A + B + C)||-5.2|-21.4|0.275
72427155|NCT02855164|144366428|SUPERIORITY|Repeated measures analysis: ALT (U/L) change from baseline to Week 12 (Parts A+B+C) Full analysis set (FAS)|LS Mean change|-11.8|STANDARD_ERROR_OF_MEAN|3.56||0.304|TWO_SIDED|95.0|-17.6|-5.9|||ANCOVA|||90 micrograms of Tropifexor vs placebo (Parts A + B + C)||-5.9|-17.6|0.304
72427156|NCT02855164|144366428|SUPERIORITY|Repeated measures analysis: ALT (U/L) change from baseline up to EOT (Parts A + B) FAS|LS Mean change|-17.1|STANDARD_ERROR_OF_MEAN|4.45||0.057|TWO_SIDED|95.0|-24.5|-9.8|||ANCOVA|||140 micrograms of Tropifexor vs placebo (Parts A + B + C)||-9.8|-24.5|0.057
72427157|NCT02855164|144366428|SUPERIORITY|Repeated measures analysis: ALT (U/L) change from baseline up to EOT (Parts A + B + C) FAS|LS Mean change|-23.0|STANDARD_ERROR_OF_MEAN|4.49||0.003|TWO_SIDED|95.0|-30.5|-15.6|||ANCOVA|||200 micrograms of Tropifexor vs placebo (Parts A + B + C)||-15.6|-30.5|0.003
72427158|NCT02855164|144366429|SUPERIORITY|Repeated measures analysis: AST (U/L) change from baseline up to EOT (Full analysis set)|LS Mean change|-9.9|STANDARD_ERROR_OF_MEAN|6.56||0.722|TWO_SIDED|95.0|-22.9|3.0|||ANCOVA|||10 micrograms of Tropifexor vs placebo (Part A)||3.0|-22.9|0.722
72336239|NCT01774097|144195874|SUPERIORITY_OR_OTHER||interaction term|-0.02|STANDARD_ERROR_OF_MEAN|0.02||0.256|TWO_SIDED|95.0|-0.06|0.02||Threshold 0.05; no adjustment for multiple comparisons per protocol.|Regression, Linear|||||0.02|-0.06|0.256
72427159|NCT02855164|144366429|SUPERIORITY|Repeated measures analysis: AST (U/L) change from baseline up to EOT (Full analysis set)|LS Mean change|-2.2|STANDARD_ERROR_OF_MEAN|5.96||0.468|TWO_SIDED|95.0|-14.0|9.5|||ANCOVA|||30 micrograms of Tropifexor vs placebo (Part A)||9.5|-14.0|0.468
72427160|NCT02855164|144366429|SUPERIORITY|Repeated measures analysis: AST (U/L) change from baseline up to EOT (Parts A+B) (Full analysis set)|LS Mean change|-8.8|STANDARD_ERROR_OF_MEAN|3.97||0.774|TWO_SIDED|95.0|-16.7|-1.0|||ANCOVA|||60 micrograms of Tropifexor vs placebo (Parts A+B)||-1.0|-16.7|0.774
72427161|NCT02855164|144366429|SUPERIORITY|Repeated measures analysis: AST (U/L) change from baseline up to EOT (Parts A+B) (Full analysis set)|LS Mean change|-0.6|STANDARD_ERROR_OF_MEAN|2.76||0.136|TWO_SIDED|95.0|-6.0|4.9|||ANCOVA|||90 micrograms of Tropifexor vs placebo (Parts A+B)||4.9|-6.0|0.136
72427162|NCT02855164|144366429|SUPERIORITY|Repeated measures analysis: AST (U/L) change from baseline up to EOT (Part C) (Full analysis set)|LS Mean change|-16.0|STANDARD_ERROR_OF_MEAN|3.97||0.145|TWO_SIDED|95.0|-23.9|-8.2|||ANCOVA|||140 micrograms of Tropifexor vs placebo (Part C)||-8.2|-23.9|0.145
72427163|NCT02855164|144366429|SUPERIORITY|Repeated measures analysis: AST (U/L) change from baseline up to EOT (Part C) (Full analysis set)|LS Mean change|-15.3|STANDARD_ERROR_OF_MEAN|4.49||0.236|TWO_SIDED|95.0|-24.2|-6.4|||ANCOVA|||200 micrograms of Tropifexor vs placebo (Part C)||-6.4|-24.2|0.236
72427164|NCT02855164|144366429|SUPERIORITY|Repeated measures analysis: AST (U/L) change from baseline up to EOT (Parts A+B+C) Full analysis set (FAS)|LS Mean change|-7.1|STANDARD_ERROR_OF_MEAN|7.0||0.788|TWO_SIDED|95.0|-18.7|4.4|||ANCOVA|||10 micrograms of Tropifexor vs placebo (Parts A+B+ C)||4.4|-18.7|0.788
72427165|NCT02855164|144366429|SUPERIORITY|Repeated measures analysis: AST (U/L) change from baseline up to EOT (Parts A+B+C) Full analysis set (FAS)|LS Mean change|0.4|STANDARD_ERROR_OF_MEAN|6.43||0.413|TWO_SIDED|95.0|-10.2|11.0|||ANCOVA|||30 micrograms of Tropifexor vs placebo (Parts A+B+ C)||11.0|-10.2|0.413
72427166|NCT02855164|144366429|SUPERIORITY|Repeated measures analysis: AST (U/L) change from baseline up to EOT (Parts A+B+C) Full analysis set (FAS)|LS Mean change|-6.2|STANDARD_ERROR_OF_MEAN|4.38||0.833|TWO_SIDED|95.0|-13.4|1.0|||ANCOVA|||60 micrograms of Tropifexor vs placebo (Parts A+B+ C)||1.0|-13.4|0.833
72427167|NCT02855164|144366429|SUPERIORITY|Repeated measures analysis: AST (U/L) change from baseline up to EOT (Parts A+B+C) Full analysis set (FAS)|LS Mean change|2.0|STANDARD_ERROR_OF_MEAN|3.19||0.068|TWO_SIDED|95.0|-3.2|7.3|||ANCOVA|||90 micrograms of Tropifexor vs placebo (Parts A+B+ C)||7.3|-3.2|0.068
72427168|NCT02855164|144366429|SUPERIORITY|Repeated measures analysis: AST (U/L) change from baseline up to EOT (Parts A+B+C) Full analysis set (FAS)|LS Mean change|-0.1|STANDARD_ERROR_OF_MEAN|3.98||0.269|TWO_SIDED|95.0|-6.6|6.5|||ANCOVA|||140 micrograms of Tropifexor vs placebo (Parts A+B+ C)||6.5|-6.6|0.269
72427169|NCT02855164|144366429|SUPERIORITY|Repeated measures analysis: AST (U/L) change from baseline up to EOT (Parts A+B+C) Full analysis set (FAS)|LS Mean change|-3.8|STANDARD_ERROR_OF_MEAN|4.05||0.777|TWO_SIDED|95.0|-10.5|2.9|||ANCOVA|||200 micrograms of Tropifexor vs placebo (Parts A+B+ C)||2.9|-10.5|0.777
72427170|NCT02855164|144366430|SUPERIORITY|ANCOVA: Relative change in percentage of fat in the liver from baseline to Week 12|LS Mean change|-7.48|STANDARD_ERROR_OF_MEAN|6.174||0.853|TWO_SIDED|95.0|-19.66|4.7|||ANCOVA|||10 microgramsof Tropifexor - Change in percentage of fat in the liver Part A||4.70|-19.66|0.853
72427171|NCT02855164|144366430|SUPERIORITY|ANCOVA: Relative change in percentage of fat in the liver from baseline to Week 12|LS Mean change|-14.07|STANDARD_ERROR_OF_MEAN|5.661||0.232|TWO_SIDED|95.0|-25.24|-2.91|||ANCOVA|||30 micrograms of Tropifexor - Change in percentage of fat in the liver Part A||-2.91|-25.24|0.232
72427172|NCT02855164|144366430|SUPERIORITY|ANCOVA: Relative change in percentage of fat in the liver from baseline to Week 12|LS Mean change|-15.04|STANDARD_ERROR_OF_MEAN|3.754||0.077|TWO_SIDED|95.0|-22.45|-7.64|||ANCOVA|||60 micrograms of Tropifexor - Change in percentage of fat in the liver Parts A+B||-7.64|-22.45|0.077
72427173|NCT02855164|144366430|SUPERIORITY|ANCOVA: Relative change in percentage of fat in the liver from baseline|LS Mean change|-12.34|STANDARD_ERROR_OF_MEAN|2.482||0.141|TWO_SIDED|95.0|-17.23|-7.44|||ANCOVA|||90 micrograms of Tropifexor - Change in percentage of fat in the liver Parts A+B||-7.44|-17.23|0.141
72427174|NCT02855164|144366430|SUPERIORITY|ANCOVA: Relative change in percentage of fat in the liver from baseline to Week 12|LS Mean change|-31.25|STANDARD_ERROR_OF_MEAN|5.228|<|0.001|TWO_SIDED|95.0|-41.58|-20.92|||ANCOVA|||140 micrograms of Tropifexor - Change in percentage of fat in the liver Part C||-20.92|-41.58|<0.001
72427175|NCT02855164|144366430|SUPERIORITY|ANCOVA: Relative change in percentage of fat in the liver from baseline to Week 12 (Parts A+B+C)|LS Mean change|-39.54|STANDARD_ERROR_OF_MEAN|4.968|<|0.001|TWO_SIDED|95.0|-49.37|-29.71|||ANCOVA|||200 micrograms of Tropifexor - Change in percentage of fat in the liver Part C||-29.71|-49.37|<0.001
72427176|NCT02855164|144366430|SUPERIORITY|ANCOVA: Relative change in percentage of fat in the liver from baseline to Week 12 (Parts A+B+C)|LS Mean change|-8.09|STANDARD_ERROR_OF_MEAN|6.65||0.872|TWO_SIDED|95.0|-19.06|2.88|||ANCOVA|||10 micrograms of Tropifexor - Change in percentage of fat in the liver Parts A+B+C||2.88|-19.06|0.872
72427177|NCT02855164|144366430|SUPERIORITY|ANCOVA: Relative change in percentage of fat in the liver from baseline to Week 12 (Parts A+B+C)|LS Mean change|-14.14|STANDARD_ERROR_OF_MEAN|6.198||0.465|TWO_SIDED|95.0|-24.36|-3.91|||ANCOVA|||30 micrograms of Tropifexor - Change in percentage of fat in the liver Parts A+B+C||-3.91|-24.36|0.465
72427178|NCT02855164|144366430|SUPERIORITY|ANCOVA: Relative change in percentage of fat in the liver from baseline to Week 12 (Parts A+B+C)|LS Mean change|-15.02|STANDARD_ERROR_OF_MEAN|4.078||0.228|TWO_SIDED|95.0|-21.75|-8.29|||ANCOVA|||60 micrograms of Tropifexor - Change in percentage of fat in the liver Parts A+B+C||-8.29|-21.75|0.228
72427179|NCT02855164|144366430|SUPERIORITY|ANCOVA: Relative change in percentage of fat in the liver from baseline to Week 12 (Parts A+B+C)|LS Mean change|-12.56|STANDARD_ERROR_OF_MEAN|2.717||0.37|TWO_SIDED|95.0|-17.04|-8.08|||ANCOVA|||90 micrograms - Change in percentage of fat in the liver Parts A+B+C||-8.08|-17.04|0.370
72427180|NCT02855164|144366430|SUPERIORITY|ANCOVA: Relative change in percentage of fat in the liver from baseline to Week 12 (Parts A+B+C)|LS Mean change|-18.71|STANDARD_ERROR_OF_MEAN|3.517||0.029|TWO_SIDED|95.0|-24.51|-12.91|||ANCOVA|||140 micrograms - Change in percentage of fat in the liver Parts A+B+C||-12.91|-24.51|0.029
72427181|NCT02855164|144366430|SUPERIORITY|ANCOVA: Relative change in percentage of fat in the liver from baseline to Week 12 (Parts A+B+C)|LS Mean change|-34.38|STANDARD_ERROR_OF_MEAN|3.482|<|0.001|TWO_SIDED|95.0|-40.13|-28.64|||ANCOVA|||200 micrograms of Tropifexor - Change in percentage of fat in the liver Parts A+B+C||-28.64|-40.13|<0.001
72427182|NCT02855164|144366431|SUPERIORITY|Repeated measures analysis: Change in weight from baseline to EOT (Parts A + B) (Full analysis set)|LS Mean change|-1.79|STANDARD_ERROR_OF_MEAN|0.608||0.01|TWO_SIDED|95.0|-2.99|0.59|||Mixed Models Analysis|||10 micrograms of Tropifexor (Part A) vs Placebo||0.59|-2.99|0.010
72336240|NCT01774097|144195875|SUPERIORITY_OR_OTHER||interaction term|0.2|STANDARD_ERROR_OF_MEAN|0.2||0.241|TWO_SIDED|95.0|-0.2|0.6|||Regression, Linear|||||0.6|-0.2|0.241
72336241|NCT01774097|144195877|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.1|STANDARD_ERROR_OF_MEAN|1.4||0.131|TWO_SIDED|95.0|-0.6|4.8||Threshold 0.05; no adjustment for multiple comparisons per protocol.|Regression, Linear|||||4.8|-0.6|0.131
72336242|NCT01774097|144195878|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.9|STANDARD_ERROR_OF_MEAN|1.7||0.626|TWO_SIDED|95.0|-2.6|4.2||Threshold 0.05; no adjustment for multiple comparisons per protocol.|Regression, Linear|||||4.2|-2.6|0.626
72336243|NCT01774097|144195879|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.9|STANDARD_ERROR_OF_MEAN|1.6||0.591|TWO_SIDED|95.0|-4.1|2.3||Threshold 0.05; no adjustment for multiple comparisons per protocol.|Regression, Linear|||||2.3|-4.1|0.591
72336244|NCT01774097|144195880|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.7|STANDARD_ERROR_OF_MEAN|2.0||0.722|TWO_SIDED|95.0|-3.3|4.7||Threshold 0.05; no adjustment for multiple comparisons per protocol.|Regression, Linear|||||4.7|-3.3|0.722
72336245|NCT01920568|144195881|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.316|||<|0.0001|TWO_SIDED|95.0|-0.44|-0.192|||ANCOVA||Primary analysis evaluated the log transformed chg from BL, i.e. log\[(Wk 13 uNTx/Cr) / (BL uNTx/Cr)\] by ANCOVA model with trt group as main effect and the stratification factor (breast cancer, yes or no) and log transformed BL value as covariates.|||-0.192|-0.440|<0.0001
72336246|NCT01920568|144195882|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.316|||<|0.0001|TWO_SIDED|95.0|-0.444|-0.188|||ANCOVA||Secondary analysis evaluated the log transformed chg from BL, ie log\[(Wk 13 uNTx/Cr)/(BL uNTx/Cr)\] by ANCOVA model with trt group as main effect and the stratification factor (Chinese participants, yes or no) and log transformed BL value|||-0.188|-0.444|<0.0001
72336247|NCT01920568|144195883|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.366|||<|0.0001|TWO_SIDED|95.0|-0.539|-0.193|||ANCOVA||Secondary analysis evaluated the log transformed chg from BL, i.e. log\[(Wk 13 uNTx/Cr) / (BL uNTx/Cr)\] by ANCOVA model with trt group as main effect, stratification factor (Breast cancer, yes or no) and log transformed BL value as covariates.|||-0.193|-0.539|<0.0001
72336248|NCT03640052|144195902|SUPERIORITY||Mean Difference (Final Values)|3.6|||>|0.5|TWO_SIDED||||||Mixed Models Analysis|||mean difference vs Placebo||||>0.5
72336249|NCT03640052|144195902|SUPERIORITY||Mean Difference (Net)|-2.0|||>|0.5|TWO_SIDED||||||Mixed Models Analysis|||mean difference vs Placebo||||>0.5
72336250|NCT03640052|144195902|SUPERIORITY||Mean Difference (Net)|-6.8|||>|0.5|TWO_SIDED||||||Mixed Models Analysis|||mean difference vs Placebo||||>0.5
72336251|NCT03640052|144195902|SUPERIORITY||Mean Difference (Net)|-11.7||||0.33|TWO_SIDED||||||Mixed Models Analysis|||mean difference vs Placebo||||0.33
72336252|NCT03640052|144195903|SUPERIORITY|||||||0.12|||||||Mixed Models Analysis|||||||0.12
72336253|NCT04239222|144195915|SUPERIORITY|A sample size of 22 subjects was required to provide 80% power to detect a difference of 5 points on the PLUS-M scale using Wilcoxon's matched pairs signed ranks test and alpha of 0.05. A standard deviation of 7.7 was used to calculate the sample size.|Mean Difference (Final Values)|1.02|STANDARD_DEVIATION|4.17||0.286|TWO_SIDED||||||Wilcoxon Signed Rank Test||Difference represents Revo-M - Everyday Foot,|HO: μRevo-M ≤ μEveryday, μRevo-M is the mean PLUS-M score using the Revo-M and μEveryday is the mean PLUS-M score using the Everyday foot at baseline.|2-sided Wilcoxon matched pairs signed ranks test, n=23 (11 negative, 8 positive and 4 null), Z=-1.066.|||0.286
72336254|NCT04239222|144195916|SUPERIORITY|A sample size of 21 subjects was required to provide 80% power to detect a difference of 0.2 points in the TAPES-AR score using Wilcoxon's matched pairs signed ranks test and alpha of 0.05. A standard deviation of 0.3 was used to calculate the sample size.|Mean Difference (Final Values)|-0.094|STANDARD_DEVIATION|0.212||0.031|TWO_SIDED||||||Wilcoxon Signed Rank Test||Difference represents Revo-M - Everyday Foot.|HO: μRevo-M ≥ μEveryday, μRevo-M is the mean TAPES-AR score using the Revo-M and μEveryday is the mean TAPES-AR score using the Everyday foot at baseline.|2-sided Wilcoxon matched pairs signed ranks test, n=23 (5 negative, 13 positive and 5 null), Z=-2.156|||0.031
72369658|NCT05407064|144249699|SUPERIORITY|||||||0.333|||||||t-test, 2 sided|||Change from baseline in total CGI-S scores determined by the difference in means and difference between treatment and placebo (p-value determined from two-sample t-test).||||0.3330
72369659|NCT05407064|144249699|SUPERIORITY|||||||0.1193|||||||t-test, 2 sided|||Change from baseline in total CGI-S scores determined by the difference in means and difference between treatment and placebo (p-value determined from two-sample t-test).||||0.1193
72369660|NCT05407064|144249699|SUPERIORITY|||||||0.0032|||||||t-test, 2 sided|||Change from baseline in total CGI-S scores determined by the difference in means and difference between treatment and placebo (p-value determined from two-sample t-test).||||0.0032
72369661|NCT05407064|144249699|SUPERIORITY|||||||0.0127|||||||t-test, 2 sided|||Change from baseline in total CGI-S scores determined by the difference in means and difference between treatment and placebo (p-value determined from two-sample t-test).||||0.0127
72369662|NCT05407064|144249700|SUPERIORITY|||||||0.0046|||||||t-test, 2 sided|||Difference in mean CGI-I total scores (MM120-placebo); p-value determined from two-sample t-test.||||0.0046
72369663|NCT05407064|144249700|SUPERIORITY|||||||0.0052|||||||t-test, 2 sided|||Difference in mean CGI-I total scores (MM120-placebo); p-value determined from two-sample t-test.||||0.0052
72369664|NCT05407064|144249700|SUPERIORITY|||||||0|||||||t-test, 2 sided|||Difference in mean CGI-I total scores (MM120-placebo); p-value determined from two-sample t-test.||||0.0000
72369665|NCT05407064|144249700|SUPERIORITY|||||||0|||||||t-test, 2 sided|||Difference in mean CGI-I total scores (MM120-placebo); p-value determined from two-sample t-test.||||0.0000
72369666|NCT05407064|144249701|SUPERIORITY|||||||0.0567|||||||t-test, 2 sided|||Difference in mean CGI-I total scores (MM120-placebo); p-value determined from two-sample t-test.||||0.0567
72369667|NCT05407064|144249701|SUPERIORITY|||||||0.0235|||||||t-test, 2 sided|||Difference in mean CGI-I total scores (MM120-placebo); p-value determined from two-sample t-test.||||0.0235
72369668|NCT05407064|144249701|SUPERIORITY|||||||0|||||||t-test, 2 sided|||Difference in mean CGI-I total scores (MM120-placebo); p-value determined from two-sample t-test.||||0.0000
72369669|NCT05407064|144249701|SUPERIORITY|||||||0|||||||t-test, 2 sided|||Difference in mean CGI-I total scores (MM120-placebo); p-value determined from two-sample t-test.||||0.0000
72369670|NCT05407064|144249702|SUPERIORITY|||||||0.2632|||||||t-test, 2 sided|||Difference in mean CGI-I total scores (MM120-placebo); p-value determined from two-sample t-test.||||0.2632
72369671|NCT05407064|144249702|SUPERIORITY|||||||0.2962|||||||t-test, 2 sided|||Difference in mean CGI-I total scores (MM120-placebo); p-value determined from two-sample t-test.||||0.2962
72369672|NCT05407064|144249702|SUPERIORITY|||||||0.0013|||||||t-test, 2 sided|||Difference in mean CGI-I total scores (MM120-placebo); p-value determined from two-sample t-test.||||0.0013
72369673|NCT05407064|144249702|SUPERIORITY|||||||0.0547|||||||t-test, 2 sided|||Difference in mean CGI-I total scores (MM120-placebo); p-value determined from two-sample t-test.||||0.0547
72369674|NCT05407064|144249703|SUPERIORITY|||||||0.0937|||||||t-test, 2 sided|||Difference in mean CGI-I total scores (MM120-placebo); p-value determined from two-sample t-test.||||0.0937
72369675|NCT05407064|144249703|SUPERIORITY|||||||0.823|||||||t-test, 2 sided|||Difference in mean CGI-I total scores (MM120-placebo); p-value determined from two-sample t-test.||||0.8230
72369676|NCT05407064|144249703|SUPERIORITY|||||||0.0032|||||||t-test, 2 sided|||Difference in mean CGI-I total scores (MM120-placebo); p-value determined from two-sample t-test.||||0.0032
72369677|NCT05407064|144249703|SUPERIORITY|||||||0.0129|||||||t-test, 2 sided|||Difference in mean CGI-I total scores (MM120-placebo); p-value determined from two-sample t-test.||||0.0129
72369678|NCT05407064|144249704|SUPERIORITY|||||||0.1889|||||||t-test, 2 sided|||Difference in mean CGI-I total scores (MM120-placebo); p-value determined from two-sample t-test.||||0.1889
72369679|NCT05407064|144249704|SUPERIORITY|||||||0.1589|||||||t-test, 2 sided|||Difference in mean CGI-I total scores (MM120-placebo); p-value determined from two-sample t-test.||||0.1589
72369680|NCT05407064|144249704|SUPERIORITY|||||||0.0008|||||||t-test, 2 sided|||Difference in mean CGI-I total scores (MM120-placebo); p-value determined from two-sample t-test.||||0.0008
72369681|NCT05407064|144249704|SUPERIORITY|||||||0.0194|||||||t-test, 2 sided|||Difference in mean CGI-I total scores (MM120-placebo); p-value determined from two-sample t-test.||||0.0194
72369682|NCT05407064|144249705|SUPERIORITY|||||||0.0057|||||||t-test, 2 sided|||Change from baseline in total PGI-S scores and the difference in means between treatment and placebo (p-value determined from two-sample t-test).||||0.0057
72369683|NCT05407064|144249705|SUPERIORITY|||||||0.0168|||||||t-test, 2 sided|||Change from baseline in total PGI-S scores and the difference in means between treatment and placebo (p-value determined from two-sample t-test).||||0.0168
72369684|NCT05407064|144249705|SUPERIORITY|||||||0|||||||t-test, 2 sided|||||||0.0000
72369685|NCT05407064|144249705|SUPERIORITY|||||||0|||||||t-test, 2 sided|||Change from baseline in total PGI-S scores and the difference in means between treatment and placebo (p-value determined from two-sample t-test).||||0.0000
72369686|NCT05407064|144249706|SUPERIORITY|||||||0.0958|||||||t-test, 2 sided|||Change from baseline in total PGI-S scores and the difference in means between treatment and placebo (p-value determined from two-sample t-test).||||0.0958
72369687|NCT05407064|144249706|SUPERIORITY|||||||0.0544|||||||t-test, 2 sided|||Change from baseline in total PGI-S scores and the difference in means between treatment and placebo (p-value determined from two-sample t-test).||||0.0544
72369688|NCT05407064|144249706|SUPERIORITY|||||||0.0029|||||||t-test, 2 sided|||Change from baseline in total PGI-S scores and the difference in means between treatment and placebo (p-value determined from two-sample t-test).||||0.0029
72369689|NCT05407064|144249706|SUPERIORITY|||||||0.0006|||||||t-test, 2 sided|||Change from baseline in total PGI-S scores and the difference in means between treatment and placebo (p-value determined from two-sample t-test).||||0.0006
72369690|NCT05407064|144249707|SUPERIORITY|||||||0.2038|||||||t-test, 2 sided|||Change from baseline in total PGI-S scores and the difference in means between treatment and placebo (p-value determined from two-sample t-test)||||0.2038
72369691|NCT05407064|144249707|SUPERIORITY|||||||0.1977|||||||t-test, 2 sided|||Change from baseline in total PGI-S scores and the difference in means between treatment and placebo (p-value determined from two-sample t-test)||||0.1977
72369692|NCT05407064|144249707|SUPERIORITY|||||||0.0357|||||||t-test, 2 sided|||Change from baseline in total PGI-S scores and the difference in means between treatment and placebo (p-value determined from two-sample t-test)||||0.0357
72369693|NCT05407064|144249707|SUPERIORITY|||||||0.0302|||||||t-test, 2 sided|||Change from baseline in total PGI-S scores and the difference in means between treatment and placebo (p-value determined from two-sample t-test)||||0.0302
72427183|NCT02855164|144366431|SUPERIORITY|Repeated measures analysis: Change in weight from baseline to EOT (Parts A + B) (Full analysis set)|LS Mean change|-0.78|STANDARD_ERROR_OF_MEAN|0.567||0.237|TWO_SIDED|95.0|-1.9|0.34|||Mixed Models Analysis|||30 micrograms of Tropifexor (Part A) vs Placebo||0.34|-1.90|0.237
72427184|NCT02855164|144366431|SUPERIORITY|Repeated measures analysis: Change in weight from baseline to EOT (Parts A + B) (Full analysis set)|LS Mean change|-1.05|STANDARD_ERROR_OF_MEAN|0.377||0.037|TWO_SIDED|95.0|-1.8|0.31|||Mixed Models Analysis|||60 micrograms of Tropifexor (Parts A + B) vs Placebo||0.31|-1.80|0.037
72427185|NCT02855164|144366431|SUPERIORITY|Repeated measures analysis: Change in weight from baseline to EOT (Parts A + B) (Full analysis set)|LS Mean change|-1.15|STANDARD_ERROR_OF_MEAN|0.253||0.007|TWO_SIDED|95.0|-1.65|0.65|||Mixed Models Analysis|||90 micrograms of Tropifexor (Parts A + B) vs Placebo||0.65|-1.65|0.007
72427186|NCT02855164|144366431|SUPERIORITY|Repeated measures analysis: Change in weight from baseline to EOT (Parts C) (Full analysis set)|LS Mean change|-5.1|STANDARD_ERROR_OF_MEAN|0.988||0.053|TWO_SIDED|95.0|-7.05|-3.14|||Mixed Models Analysis|||140 micrograms of Tropifexor (Part C) vs Placebo||-3.14|-7.05|0.053
72427187|NCT02855164|144366431|SUPERIORITY|Repeated measures analysis: Change in weight from baseline to EOT (Parts C) (Full analysis set)|LS Mean change|-5.89|STANDARD_ERROR_OF_MEAN|1.002||0.013|TWO_SIDED|95.0|-7.87|-3.91|||Mixed Models Analysis|||200 micrograms of Tropifexor (Part C) vs Placebo||-3.91|-7.87|0.013
72427188|NCT02855164|144366432|SUPERIORITY|Repeated measures analysis: Change in BMI from baseline to EOT (Full analysis set)|LS Mean change|-0.64|STANDARD_ERROR_OF_MEAN|0.208||0.006|TWO_SIDED|95.0|-1.05|0.23|||Mixed Models Analysis|||10 micrograms of Tropifexor (Part A) vs Placebo||0.23|-1.05|0.006
72427189|NCT02855164|144366432|SUPERIORITY|Repeated measures analysis: Change in BMI from baseline to EOT (Full analysis set)|LS Mean change|-0.29|STANDARD_ERROR_OF_MEAN|0.194||0.177|TWO_SIDED|95.0|-0.67|0.09|||Mixed Models Analysis|||30 micrograms of Tropifexor (Part A) vs Placebo||0.09|-0.67|0.177
72427190|NCT02855164|144366432|SUPERIORITY|Repeated measures analysis: Change in BMI from baseline to EOT (Parts C) (Full analysis set)|LS Mean change|-0.35|STANDARD_ERROR_OF_MEAN|0.129||0.032|TWO_SIDED|95.0|-0.61|0.1|||Mixed Models Analysis|||60 micrograms of Tropifexor (Parts A + B) vs Placebo||0.10|-0.61|0.032
72427191|NCT02855164|144366432|SUPERIORITY|Repeated measures analysis: Change in BMI from baseline to EOT (Full analysis set)|LS Mean change|-0.42|STANDARD_ERROR_OF_MEAN|0.087||0.003|TWO_SIDED|95.0|-0.59|0.25|||Mixed Models Analysis|||90 micrograms of Tropifexor (Parts A + B) vs Placebo||0.25|-0.59|0.003
72427192|NCT02855164|144366432|SUPERIORITY|Repeated measures analysis: Change in BMI from baseline to EOT (Full analysis set)|LS Mean change|-1.88|STANDARD_ERROR_OF_MEAN|0.322||0.015|TWO_SIDED|95.0|-2.51|-1.24|||Mixed Models Analysis|||140 micrograms of Tropifexor (Part C) vs Placebo||-1.24|-2.51|0.015
72427193|NCT02855164|144366432|SUPERIORITY|Repeated measures analysis: Change in BMI from baseline to EOT (Parts C) (Full analysis set)|LS Mean change|-2.11|STANDARD_ERROR_OF_MEAN|0.327||0.004|TWO_SIDED|95.0|-2.75|-1.46|||Mixed Models Analysis|||200 micrograms of Tropifexor (Part C) vs Placebo||-1.46|-2.75|0.004
72427194|NCT02855164|144366433|SUPERIORITY|Repeated measures analysis: Change in WTH ratio from baseline to EOT (Parts A+B) (Full analysis set)|LS Mean change|-0.01|STANDARD_ERROR_OF_MEAN|0.009||0.53|TWO_SIDED|95.0|-0.03|0.01|||Mixed Models Analysis|||10 micrograms of Tropifexor (Part A) vs Placebo||0.01|-0.03|0.530
72427195|NCT02855164|144366433|SUPERIORITY|Repeated measures analysis: Change in WTH ratio from baseline to EOT (Parts A+B) (Full analysis set)|LS Mean change|0.0|STANDARD_ERROR_OF_MEAN|0.008||0.857|TWO_SIDED|95.0|-0.02|0.01|||Mixed Models Analysis|||30 micrograms of Tropifexor (Part A) vs Placebo||0.01|-0.02|0.857
72427196|NCT02855164|144366433|SUPERIORITY|Repeated measures analysis: Change in WTH ratio from baseline to EOT (Parts A+B) (Full analysis set)|LS Mean change|-0.01|STANDARD_ERROR_OF_MEAN|0.005||0.262|TWO_SIDED|95.0|-0.02|0.0|||Mixed Models Analysis|||60 micrograms of Tropifexor (Part A) vs Placebo||0.00|-0.02|0.262
72427197|NCT02855164|144366433|SUPERIORITY|Repeated measures analysis: Change in WTH ratio from baseline to EOT (Parts A+B) (Full analysis set)|LS Mean change|0.0|STANDARD_ERROR_OF_MEAN|0.004||0.323|TWO_SIDED|95.0|0.0|0.01|||Mixed Models Analysis|||90 micrograms of Tropifexor (Parts A + B) vs Placebo||0.01|0.00|0.323
72427198|NCT02855164|144366433|SUPERIORITY|Repeated measures analysis: Change in WTH ratio from baseline to EOT (Part C) (Full analysis set)|LS Mean change|0.01|STANDARD_ERROR_OF_MEAN|0.008||0.1|TWO_SIDED|95.0|-0.02|0.01|||Mixed Models Analysis|||140 micrograms of Tropifexor (Part C) vs Placebo||0.01|-0.02|0.100
72427199|NCT02855164|144366433|SUPERIORITY|Repeated measures analysis: Change in WTH ratio from baseline to EOT (Part C) (Full analysis set)|LS Mean change|-0.01|STANDARD_ERROR_OF_MEAN|0.007||0.693|TWO_SIDED|95.0|-0.03|0.0|||Mixed Models Analysis|||200 micrograms of Tropifexor (Part C) vs Placebo||0.00|-0.03|0.693
72427200|NCT02855164|144366445|SUPERIORITY||Risk Difference (RD)|0.004||||1|TWO_SIDED|95.0|-0.214|0.223|||Mixed Models Analysis|||At least one point improvement in fibrosis (NASH CRN staging) without worsening of steatohepatitis (total score)||0.223|-0.214|1.0000
72427201|NCT02855164|144366445|SUPERIORITY||Risk Difference (RD)|0.029||||0.8074|TWO_SIDED|95.0|-0.196|0.251|||Mixed Models Analysis|||At least one point improvement in fibrosis (NASH CRN staging) without worsening of steatohepatitis (total score)||0.251|-0.196|0.8074
72427202|NCT02855164|144366446|SUPERIORITY||Risk Difference (RD)|0.028||||0.807|TWO_SIDED|95.0|-0.191|0.246|||Mixed Models Analysis|||At least one point improvement in fibrosis (NASH CRN staging) without worsening of steatohepatitis (FDA)||0.246|-0.191|0.8070
72427203|NCT02855164|144366446|SUPERIORITY||Risk Difference (RD)|0.052||||0.6233|TWO_SIDED|95.0|-0.173|0.273|||Mixed Models Analysis|||At least one point improvement in fibrosis (NASH CRN staging) without worsening of steatohepatitis (FDA)||0.273|-0.173|0.6233
72427204|NCT02855164|144366447|SUPERIORITY||Risk Difference (RD)|0.004||||1|TWO_SIDED|95.0|-0.214|0.233|||Mixed Models Analysis|||At least one point improvement in fibrosis (NASH CRN staging) without worsening of steatohepatitis (EMA)||0.233|-0.214|1.0000
72427205|NCT02855164|144366447|SUPERIORITY||Risk Difference (RD)|0.029||||0.8074|TWO_SIDED|95.0|-0.196|0.251|||Mixed Models Analysis|||At least one point improvement in fibrosis (NASH CRN staging) without worsening of steatohepatitis (EMA)||0.251|-0.196|0.8074
72427206|NCT02855164|144366448|SUPERIORITY||Risk Difference (RD)|0.034||||0.7028|TWO_SIDED|95.0|-0.184|0.252|||Mixed Models Analysis|||Resolution of steatohepatitis (diagnostic category) without worsening of fibrosis (NASH CRN staging)||0.252|-0.184|0.7028
72427207|NCT02855164|144366448|SUPERIORITY||Risk Difference (RD)|0.129||||0.1713|TWO_SIDED|95.0|-0.098|0.345|||Mixed Models Analysis|||Resolution of steatohepatitis (diagnostic category) without worsening of fibrosis (NASH CRN staging)||0.345|-0.098|0.1713
72427208|NCT02855164|144366449|SUPERIORITY||Risk Difference (RD)|0.057||||0.2033|TWO_SIDED|95.0|-0.168|0.278|||Mixed Models Analysis|||Resolution of steatohepatitis (FDA, EMA) without worsening of fibrosis (NASH CRN staging)||0.278|-0.168|0.2033
72427209|NCT01644474|144366476|SUPERIORITY_OR_OTHER||LS Mean Difference|-31.6|||<|0.0001|TWO_SIDED|95.0|-40.2|-23.0||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs Ezetimibe|Alirocumab group was compared to ezetimibe group using an appropriate contrast statement.||-23.0|-40.2|<0.0001
72427210|NCT01644474|144366477|SUPERIORITY_OR_OTHER||LS Mean Difference|-28.5|||<|0.0001|TWO_SIDED|95.0|-35.7|-21.2||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs Ezetimibe|A hierarchical testing procedure was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when previous endpoint was statistically significant at 0.05 level.||-21.2|-35.7|<0.0001
72427211|NCT01644474|144366478|SUPERIORITY_OR_OTHER||LS Mean Difference|-25.8|||<|0.0001|TWO_SIDED|95.0|-32.3|-19.2||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs Ezetimibe|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-19.2|-32.3|<0.0001
72427212|NCT01644474|144366479|SUPERIORITY_OR_OTHER||LS Mean Difference|-25.5|||<|0.0001|TWO_SIDED|95.0|-33.5|-17.4||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs Ezetimibe|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-17.4|-33.5|<0.0001
72427213|NCT01644474|144366480|SUPERIORITY_OR_OTHER||LS Mean Difference|-18.7|||<|0.0001|TWO_SIDED|95.0|-24.7|-12.7||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs Ezetimibe|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-12.7|-24.7|<0.0001
72427214|NCT01644474|144366481|SUPERIORITY_OR_OTHER||LS Mean Difference|-25.7|||<|0.0001|TWO_SIDED|95.0|-31.5|-19.8||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs Ezetimibe|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-19.8|-31.5|<0.0001
72427215|NCT01644474|144366482|SUPERIORITY_OR_OTHER||LS Mean Difference|-25.8|||<|0.0001|TWO_SIDED|95.0|-32.4|-19.2||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs Ezetimibe|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-19.2|-32.4|<0.0001
72427216|NCT01644474|144366483|SUPERIORITY_OR_OTHER||LS Mean Difference|-18.3|||<|0.0001|TWO_SIDED|95.0|-23.1|-13.5||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs Ezetimibe|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-13.5|-23.1|<0.0001
72427217|NCT01644474|144366484|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|34.8|||<|0.0001|TWO_SIDED|95.0|8.7|139.0||Threshold for significance ≤ 0.05.|Regression, Logistic|Multiple imputation approach followed by logistic regression model.|Alirocumab vs Ezetimibe|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||139.0|8.7|<0.0001
72427218|NCT01644474|144366485|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|69.8||||0.0001|TWO_SIDED|95.0|8.8|556.0||Threshold for significance was ≤ 0.05.|Regression, Logistic|Multiple imputation approach followed by logistic regression model.|Alirocumab vs Ezetimibe|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||556.0|8.8|0.0001
72427219|NCT01644474|144366486|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-4.4||||0.4013|TWO_SIDED|95.0|-14.8|5.9||Threshold for significance ≤ 0.05.|Regression, Robust|Multiple imputation approach followed by robust regression model.|Alirocumab vs Ezetimibe|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||5.9|-14.8|0.4013
72427220|NCT02044458|144366495|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7|||||||t-test, 2 sided|||||||.70
72427221|NCT02044458|144366496|SUPERIORITY_OR_OTHER_LEGACY|||||||0.38|||||||t-test, 2 sided|||||||.38
72427222|NCT02044458|144366497|SUPERIORITY_OR_OTHER_LEGACY|||||||0.57|||||||Chi-squared|||||||.57
72427223|NCT00802737|144366509|SUPERIORITY_OR_OTHER||proportion of responders|0.24|||||TWO_SIDED|95.0|0.07|0.5|||||Two-sided 95% exact confidence intervals were calculated based on the binomial distribution. The estimated value was calculated using the number of responders (CR+nPR+PR) as the numerator and the total number of par. in the group as the denominator.|||0.50|0.07|
72427224|NCT00802737|144366509|SUPERIORITY_OR_OTHER||proportion of responders|0.18|||||TWO_SIDED|95.0|0.02|0.52|||||Two-sided 95% exact confidence intervals were calculated based on the binomial distribution. The estimated value was calculated using the number of responders (CR+nPR+PR) as the numerator and the total number of par. in the group as the denominator.|||0.52|0.02|
72427225|NCT00802737|144366509|SUPERIORITY_OR_OTHER||proportion of responders|1.0|||||TWO_SIDED|95.0|0.03|1.0|||||Two-sided 95% exact confidence intervals were calculated based on the binomial distribution. The estimated value was calculated using the number of responders (CR+nPR+PR) as the numerator and the total number of par. in the group as the denominator.|||1.00|0.03|
72427226|NCT03677128|144366522|OTHER||Mean Difference (Final Values)|23.8|||<|0.001|TWO_SIDED||||||Kruskal-Wallis|||||||<0.001
72427227|NCT03677128|144366522|OTHER||Mean Difference (Final Values)|21.1|||<|0.001|TWO_SIDED||||||Kruskal-Wallis|||||||<0.001
72427228|NCT00445601|144366546|SUPERIORITY||Hazard Ratio (HR)|0.66||||0.01|TWO_SIDED|95.0|0.48|0.9|||Log Rank|||||0.90|0.48|0.01
72427229|NCT00445601|144366547|SUPERIORITY||Hazard Ratio (HR)|0.51||||0.23|TWO_SIDED|95.0|0.18|1.49|||Log Rank|||||1.49|0.18|0.23
72427230|NCT00214903|144366550|NON_INFERIORITY_OR_EQUIVALENCE|Sample size calculations were based on a non-inferiority test to exclude a two-fold risk of cardiovascular events in users of DRSP/E2 compared to other oral continuous combined HRT. These calculations are based on the following assumptions: 1) one-sided α 0.05; 2) power (1-β) of 0.80; 3) Estimated incidence of cardiovascular events, ATE and VTE would be at least 1.0, 0.3 and 0.2 event/100 woman-years and 4) non-inferiority limit hazard ratio of 2.|Hazard Ratio (HR)|0.8|||||TWO_SIDED|95.0|0.5|1.3|||||Hazard ratio was adjusted for age, BMI, duration of current use, family history of VTE, region, and HRT user status.|Tested null hypotheses: the VTE hazard ratio for DRSP/E2 vs. ooccHRT is higher or equal to 2.||1.3|0.5|
72369694|NCT05407064|144249708|SUPERIORITY|||||||0.2165|||||||t-test, 2 sided|||Change from baseline in total PGI-S scores and the difference in means between treatment and placebo (p-value determined from two-sample t-test).||||0.2165
72369695|NCT05407064|144249708|SUPERIORITY|||||||0.6868|||||||t-test, 2 sided|||Change from baseline in total PGI-S scores and the difference in means between treatment and placebo (p-value determined from two-sample t-test).||||0.6868
72369696|NCT05407064|144249708|SUPERIORITY|||||||0.135|||||||t-test, 2 sided|||Change from baseline in total PGI-S scores and the difference in means between treatment and placebo (p-value determined from two-sample t-test).||||0.1350
72369697|NCT05407064|144249708|SUPERIORITY|||||||0.0273|||||||t-test, 2 sided|||Change from baseline in total PGI-S scores and the difference in means between treatment and placebo (p-value determined from two-sample t-test).||||0.0273
72369698|NCT05407064|144249709|SUPERIORITY|||||||0.245|||||||t-test, 2 sided|||Change from baseline in total PGI-S scores and the difference in means between treatment and placebo (p-value determined from two-sample t-test).||||0.2450
72369699|NCT05407064|144249709|SUPERIORITY|||||||0.3461|||||||t-test, 2 sided|||Change from baseline in total PGI-S scores and the difference in means between treatment and placebo (p-value determined from two-sample t-test).||||0.3461
72369700|NCT05407064|144249709|SUPERIORITY|||||||0.111|||||||t-test, 2 sided|||Change from baseline in total PGI-S scores and the difference in means between treatment and placebo (p-value determined from two-sample t-test).||||0.1110
72369701|NCT05407064|144249709|SUPERIORITY|||||||0.2386|||||||t-test, 2 sided|||Change from baseline in total PGI-S scores and the difference in means between treatment and placebo (p-value determined from two-sample t-test).||||0.2386
72369702|NCT05407064|144249710|SUPERIORITY|||||||0.1475|||||||t-test, 2 sided|||Difference in mean PGI-C total scores (MM120-placebo); p-value determined from two-sample t-test.||||0.1475
72369703|NCT05407064|144249710|SUPERIORITY|||||||0.0308|||||||t-test, 2 sided|||Difference in mean PGI-C total scores (MM120-placebo); p-value determined from two-sample t-test.||||0.0308
72369704|NCT05407064|144249710|SUPERIORITY|||||||0|||||||t-test, 2 sided|||Difference in mean PGI-C total scores (MM120-placebo); p-value determined from two-sample t-test.||||0.0000
72369705|NCT05407064|144249710|SUPERIORITY|||||||0.0004|||||||t-test, 2 sided|||Difference in mean PGI-C total scores (MM120-placebo); p-value determined from two-sample t-test.||||0.0004
72369706|NCT05407064|144249711|SUPERIORITY|||||||0.0873|||||||t-test, 2 sided|||Difference in mean PGI-C total scores (MM120-placebo); p-value determined from two-sample t-test.||||0.0873
72369707|NCT05407064|144249711|SUPERIORITY|||||||0.1702|||||||t-test, 2 sided|||Difference in mean PGI-C total scores (MM120-placebo); p-value determined from two-sample t-test.||||0.1702
72369708|NCT05407064|144249711|SUPERIORITY|||||||0.0007|||||||t-test, 2 sided|||Difference in mean PGI-C total scores (MM120-placebo); p-value determined from two-sample t-test.||||0.0007
72369709|NCT05407064|144249711|SUPERIORITY|||||||0.0001|||||||t-test, 2 sided|||Difference in mean PGI-C total scores (MM120-placebo); p-value determined from two-sample t-test.||||0.0001
72369710|NCT05407064|144249712|SUPERIORITY|||||||0.4193|||||||t-test, 2 sided|||Difference in mean PGI-C total scores (MM120-placebo); p-value determined from two-sample t-test.||||0.4193
72369711|NCT05407064|144249712|SUPERIORITY|||||||0.1663|||||||t-test, 2 sided|||Difference in mean PGI-C total scores (MM120-placebo); p-value determined from two-sample t-test.||||0.1663
72369712|NCT05407064|144249712|SUPERIORITY|||||||0.0002|||||||t-test, 2 sided|||Difference in mean PGI-C total scores (MM120-placebo); p-value determined from two-sample t-test.||||0.0002
72369713|NCT05407064|144249712|SUPERIORITY|||||||0.0306|||||||t-test, 2 sided|||Difference in mean PGI-C total scores (MM120-placebo); p-value determined from two-sample t-test.||||0.0306
72369714|NCT05407064|144249713|SUPERIORITY|||||||0.0534|||||||t-test, 2 sided|||Difference in mean PGI-C total scores (MM120-placebo); p-value determined from two-sample t-test||||0.0534
72369715|NCT05407064|144249713|SUPERIORITY|||||||0.6551|||||||t-test, 2 sided|||Difference in mean PGI-C total scores (MM120-placebo); p-value determined from two-sample t-test||||0.6551
72369716|NCT05407064|144249713|SUPERIORITY|||||||0.0079|||||||t-test, 2 sided|||Difference in mean PGI-C total scores (MM120-placebo); p-value determined from two-sample t-test||||0.0079
72369717|NCT05407064|144249713|SUPERIORITY|||||||0.1133|||||||t-test, 2 sided|||Difference in mean PGI-C total scores (MM120-placebo); p-value determined from two-sample t-test||||0.1133
72369718|NCT05407064|144249714|SUPERIORITY|||||||0.1248|||||||t-test, 2 sided|||Difference in mean PGI-C total scores (MM120-placebo); p-value determined from two-sample t-test.||||0.1248
72369719|NCT05407064|144249714|SUPERIORITY|||||||0.1788|||||||t-test, 2 sided|||Difference in mean PGI-C total scores (MM120-placebo); p-value determined from two-sample t-test.||||0.1788
72369720|NCT05407064|144249714|SUPERIORITY|||||||0.003|||||||t-test, 2 sided|||Difference in mean PGI-C total scores (MM120-placebo); p-value determined from two-sample t-test.||||0.0030
72369721|NCT05407064|144249714|SUPERIORITY|||||||0.0534|||||||t-test, 2 sided|||Difference in mean PGI-C total scores (MM120-placebo); p-value determined from two-sample t-test.||||0.0534
72369722|NCT02930018|144249748|SUPERIORITY|It is hypothesized that the cleavage of nerinetide by plasmin which is activated by tissue plasminogen activators, such as alteplase results in a treatment modification of nerinetide in AIS (Acute Ischemic Stroke) patients with prior administration of alteplase as part of standard-of-care.|Odds Ratio (OR)|1.146||||0.335|TWO_SIDED|95.0|0.869|1.511||2 sided 0.05 significance level.|Regression, Logistic|||The primary hypothesis was that administration of nerinetide (NA-1) would result in an increase in the proportion of responders. The primary analysis was a Wald test for treatment group difference in the primary outcome from a logistic regression adjusted for the 2 stratification variables (alteplase use, first declared thrombectomy device), and the 6 covariates used in the minimization. The trial was designed to have 80% power to detect an 8.7% absolute difference between groups.||1.511|0.869|0.335
72336255|NCT04239222|144195918|SUPERIORITY||Mean Difference (Final Values)|0.331|STANDARD_DEVIATION|8.29||0.421|TWO_SIDED||||||Wilcoxon Signed Rank Test||Difference represents Revo-M - Everyday Foot.|HO: μRevo-M ≤ μEveryday, μRevo-M is the mean ABC score using the Revo-M and μEveryday is the mean ABC score using the Everyday foot at baseline.|2-sided Wilcoxon matched pairs signed ranks test, n=23 (12 negative, 7 positive and 4 null), Z=-0.805.|||0.421
72336256|NCT04239222|144195919|SUPERIORITY||Mean Difference (Final Values)|0.087|STANDARD_DEVIATION|0.844||0.443|TWO_SIDED||||||Wilcoxon Signed Rank Test||Difference represents Revo-M - Everyday Foot.|HO: μRevo-M ≤ μEveryday, μRevo-M is the mean TAPES-FUN score using the Revo-M and μEveryday is the mean TAPES-FUN score using the Everyday foot at baseline.|2-sided Wilcoxon matched pairs signed ranks test, n=23 (6 negative, 9 positive and 8 null), Z=-0.767.|||0.443
72336257|NCT04762043|144195950|SUPERIORITY||Mean Difference (Final Values)|56.55|STANDARD_ERROR_OF_MEAN|1.64|<|0.001|TWO_SIDED|95.0|53.33|59.76|||Mixed Models Analysis|Effect size used for mixed effects model is partial eta-squared (ηp2).||||59.76|53.33|<.001
72336258|NCT01468233|144195974|SUPERIORITY_OR_OTHER_LEGACY||Adjusted mean difference|31.5|||<|0.001|TWO_SIDED|95.0|20.7|42.2||P-value adjusted for baseline Hurley Stage and for baseline antibiotic use (Y/N).|Cochran-Mantel-Haenszel|||||42.2|20.7|<0.001
72336259|NCT01468233|144195974|SUPERIORITY_OR_OTHER_LEGACY||Adjusted mean difference|25.5|||<|0.001|TWO_SIDED|95.0|10.5|40.5||P-value adjusted for baseline antibiotic use (Y/N).|Cochran-Mantel-Haenszel|||||40.5|10.5|<0.001
72336260|NCT01468233|144195974|SUPERIORITY_OR_OTHER_LEGACY||Adjusted mean difference|38.1|||<|0.001|TWO_SIDED|95.0|22.8|53.3||P-value adjusted for baseline antibiotic use (Y/N).|Cochran-Mantel-Haenszel|||||53.3|22.8|<0.001
72336261|NCT01468233|144195975|SUPERIORITY_OR_OTHER_LEGACY||Adjusted mean difference|19.5|||=|0.01|TWO_SIDED|95.0|4.7|34.2||P-value adjusted for baseline antibiotics use (Y/N).|Cochran-Mantel-Haenszel|||Secondary end points 1 (AN 0/1/2 counts), 2 (NRS30), and 3 (modified Sartorius score) were ranked analyses.||34.2|4.7|=0.01
72336262|NCT01468233|144195976|SUPERIORITY_OR_OTHER_LEGACY||Adjusted mean difference|25.1|||<|0.001|TWO_SIDED|95.0|12.7|37.6||P-value adjusted for baseline Hurley Stage and antibiotics use (Y/N).|Cochran-Mantel-Haenszel|||Secondary end points 1 (AN 0/1/2 counts), 2 (NRS30), and 3 (modified Sartorius score) were ranked analyses.||37.6|12.7|<0.001
72336263|NCT01468233|144195977|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-19.4|||<|0.001|TWO_SIDED|95.0|-28.6|-10.1||P-value calculated from ANCOVA with stratum (baseline Hurley Stage and antibiotics use), baseline value, and treatment as covariates.|ANCOVA|||Secondary end points 1 (AN 0/1/2 counts), 2 (NRS30), and 3 (modified Sartorius score) were ranked analyses.||-10.1|-28.6|<0.001
72336264|NCT01133626|144196015|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority would be demonstrated if the lower limit of a two-sided 95% CI for the geometric mean ratio of BDP HFA 320 mcg/day to placebo was greater than 0.80.|geometric mean ratio|0.96|||||TWO_SIDED|95.0|0.87|1.06|||ANCOVA|||||1.06|0.87|
72336265|NCT04545047|144196069|SUPERIORITY||Risk Difference (RD)|0.3|||||TWO_SIDED|95.0|-2.3|3.6||||||The investigators estimated the 30-day mortality risk difference comparing patients assigned to each group. Adjustment for covariates would be carried out via inverse probability weighting.||3.60|-2.30|
72336266|NCT04545047|144196069|SUPERIORITY||Hazard Ratio (HR)|1.04|||||TWO_SIDED|95.0|0.64|1.62||||||The investigators estimated the 30-day mortality hazard ratio comparing patients assigned to each group. The hazard ratio was estimated from pooled logistic models with inverse probability weighting to adjust for confounding.||1.62|0.64|
72336267|NCT01514240|144196075|NON_INFERIORITY_OR_EQUIVALENCE|A 2-sided 90% CI for the observed difference in the primary outcome measure (remission rate) between the D9421-C 9mg group and the Mesalazine 3 g group was calculated at week 8 using the Newcombe-Wilson score method without continuity correction. Noninferiority was concluded if the lower limit of the 90% CI was higher than -10% in FAS Population.|Difference of proportion|5.4||||0.526|TWO_SIDED|90.0|-8.49|18.94|||Chi-squared|||The primary objective of this study was to determine non-inferiority in the differences in remission rates at Week 8 for D9421-C 9 mg as compared to Mesalazine 3 g.||18.94|-8.49|0.526
72336268|NCT01514240|144196076|SUPERIORITY_OR_OTHER||Difference of proportion|1.8||||0.768|TWO_SIDED|90.0|-8.54|12.15|||Chi-squared||Differences in remission rate at Week 2 between D9421-C 9 mg and Mesalazine 3 g along with their 2-sided 90% CIs calculated by the Newcombe-Wilson score method without continuity correction|||12.15|-8.54|0.768
72336269|NCT01514240|144196077|SUPERIORITY_OR_OTHER||Difference of proportion|8.9||||0.208|TWO_SIDED|90.0|-2.87|20.58|||Chi-squared||Differences in remission rate at Week 4 between D9421-C 9 mg and Mesalazine 3 g along with their 2-sided 90% CIs calculated by the Newcombe-Wilson score method without continuity correction|||20.58|-2.87|0.208
72336270|NCT01514240|144196078|SUPERIORITY_OR_OTHER||LS mean difference between group|-22.8|STANDARD_ERROR_OF_MEAN|11.89||0.058|TWO_SIDED|90.0|-42.55|-3.09|||Mixed Models Analysis||The analysis using a MMRM analysis including a covariate of the corresponding score at baseline,fixed effects of time (as a categorical factor) and treatment and interaction between time and treatment group.|||-3.09|-42.55|0.058
72336271|NCT01514240|144196079|SUPERIORITY_OR_OTHER||LS mean difference between group|-30.0|STANDARD_ERROR_OF_MEAN|12.05||0.014|TWO_SIDED|90.0|-49.95|-9.96|||Mixed Models Analysis||The analysis using a MMRM analysis including a covariate of the corresponding score at baseline,fixed effects of time (as a categorical factor) and treatment and interaction between time and treatment group.|||-9.96|-49.95|0.014
72427231|NCT00214903|144366551|NON_INFERIORITY_OR_EQUIVALENCE|Sample size calculations were based on a non-inferiority test to exclude a two-fold risk of cardiovascular events in users of DRSP/E2 compared to other oral continuous combined HRT. These calculations are based on the following assumptions: 1) one-sided α 0.05; 2) power (1-β) of 0.80; 3) Estimated incidence of cardiovascular events, ATE and VTE would be at least 1.0, 0.3 and 0.2 event/100 woman-years and 4) non-inferiority limit hazard ratio of 2.|Hazard Ratio (HR)|0.5|||||TWO_SIDED|95.0|0.3|0.8|||||Hazard ratio was adjusted for age, BMI, hypertension, diabetes, family history of fatal ATE, region, and smoking.|Tested null hypotheses: the ATE hazard ratio for DRSP/E2 vs. ooccHRT is higher or equal to 2.||0.8|0.3|
72427232|NCT01807221|144366568|OTHER||Mean Difference (Final Values)|-6.3||||0.8771|TWO_SIDED|90.0|-14.9|2.3|||Chi-squared|||Estimates and two-sided 90% confidence intervals are provided for each treatment group and for the treatment differences πBi - πC. Clopper-Pearson confidence intervals were calculated for each treatment group, while for treatment differences the exact unconditional confidence limits were calculated.||2.3|-14.9|0.8771
72427233|NCT01807221|144366568|OTHER||Mean Difference (Final Values)|-4.7||||0.7945|TWO_SIDED|90.0|-13.4|4.0|||Chi-squared|||Estimates and two-sided 90% confidence intervals are provided for each treatment group and for the treatment differences πBi - πC. Clopper-Pearson confidence intervals were calculated for each treatment group, while for treatment differences the exact unconditional confidence limits were calculated.||4|-13.4|0.7945
72427234|NCT01807221|144366568|OTHER||Mean Difference (Final Values)|0.1||||0.5|TWO_SIDED|90.0|-8.5|8.8|||Chi-squared|||Estimates and two-sided 90% confidence intervals are provided for each treatment group and for the treatment differences πBi - πC. Clopper-Pearsonconfidence intervals were calculated for each treatment group, while for treatment differences the exact unconditional confidence limits were calculated.||8.8|-8.5|0.5
72427235|NCT01807221|144366568|OTHER||Mean Difference (Final Values)|1.6||||0.4225|TWO_SIDED|90.0|-7.1|10.2|||Chi-squared|||Estimates and two-sided 90% confidence intervals are provided for each treatment group and for the treatment differences πBi - πC. Clopper-Pearsonconfidence intervals were calculated for each treatment group, while for treatment differences the exact unconditional confidence limits were calculated.||10.2|-7.1|0.4225
72427236|NCT01807221|144366568|OTHER||Mean Difference (Final Values)|-3.0||||0.6865|TWO_SIDED|90.0|-11.7|5.7|||Chi-squared|||Estimates and two-sided 90% confidence intervals are provided for each treatment group and for the treatment differences πBi - πC. Clopper-Pearson confidence intervals were calculated for each treatment group, while for treatment differences the exact unconditional confidence limits were calculated.||5.7|-11.7|0.6865
72427237|NCT02609659|144366580|NON_INFERIORITY|The noninferiority of the rate of sustained virologic response at 12 weeks after treatment for the 3-DAA + RBV 600 mg treatment group as compared with the historical rate for 3-DAA + weight-based RBV was analyzed; the lower confidence bound of the 2-sided 95% confidence interval (95% CI) for the percentage of participants with sustained virologic response at 12 weeks after treatment must exceed 92% to achieve noninferiority.|percentage of participants|89.5|||||TWO_SIDED|95.0|83.7|95.4||||||||95.4|83.7|
72427238|NCT00390455|144366604|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The null hypothesis then is that the hazard ratio of the two treatment arms is 1.0; the alternative hypothesis is that the hazard ratio of the control to the experimental regimen is 1.5 (0.67). The test of these hypotheses is one-sided (alpha = 0.025), and interim analyses will be used to stop for futility and superiority. Under these assumptions, there is at least 90% power to detect the stated difference in median PFS between the two treatment arms.|Hazard Ratio (HR)|1.04||||0.37|TWO_SIDED|95.0|0.82|1.33||Tests were stratified by prior tamoxifen therapy (yes/no) and bone disease only (yes/no).|Log Rank|||||1.33|0.82|0.37
72427239|NCT04076020|144366618|SUPERIORITY|||||||0.99||||||Results presented from Wilcoxon-Mann-Whitney test with PDC as the dependent variable.|Wilcoxon (Mann-Whitney)|||Proportion of days covered (PDC) at 12 months. A sample size of 119 in each study arm enabled us to detect a minimum difference in PDC of 11.7% with 85% power (assuming a standard deviation=30%). Our power calculations assume use of 2-sided tests with 0.05 significance level.||||0.99
72427240|NCT04076020|144366618|SUPERIORITY||||||<|0.05|||||||Regression, Logistic|||Proportion of days covered (PDC) analyzed as a binary variable with optimal adherence determined as ≥0.80) variables using logistic regression and adjustment for trial stratification factors. Our power calculations assume use of 2-sided tests with 0.05 significance level.||||<0.05
72427241|NCT04076020|144366619|SUPERIORITY||||||<|0.05|||||||Regression, Logistic|||Difference in self-reported adherence reported across baseline, 4-, 8-, and 12-month visits using generalized estimating equations and adjusted for trial stratification factors.||||<0.05
72427242|NCT02524054|144366627|SUPERIORITY|||||||0.35||||||The p-value is not adjusted for multiple comparisons and the a priori threshold for statistical significance was 0.05.|t-test, 2 sided|||This is a paired t-test comparing the treatment effect of furosemide to the treatment effect of saline in each individual.||||0.35
72427243|NCT02524054|144366628|SUPERIORITY||||||<|0.001||||||The p-value is not adjusted for multiple comparisons, and the a priori threshold for significance was 0.05.|t-test, 2 sided|||||||<0.001
72427244|NCT03537261|144366632|SUPERIORITY||Mean Difference (Net)|5.8||||0.11|TWO_SIDED|95.0|-1.4|13.1|||Regression, Linear|Repeated measures linear regression controlling for score at screening visit|(P-CPI training change) - (waitlist change)|||13.1|-1.4|0.11
72427245|NCT03537261|144366633|SUPERIORITY||Mean Difference (Net)|-2.2||||0.4|TWO_SIDED|95.0|-7.4|3.0|||Regression, Linear|Repeated measures linear regression controlling for score at screening visit|(P-CPI training change) - (waitlist change)|||3.0|-7.4|0.40
72427246|NCT03537261|144366634|SUPERIORITY||Mean Difference (Net)|0.6||||0.72|TWO_SIDED|95.0|-2.9|4.2|||Regression, Linear|Repeated measures linear regression controlling for score at screening visit|(P-CPI training change) - (waitlist change)|||4.2|-2.9|0.72
72336272|NCT01514240|144196080|SUPERIORITY_OR_OTHER||LS mean difference between group|-21.4|STANDARD_ERROR_OF_MEAN|14.53||0.144|TWO_SIDED|90.0|-45.47|2.74|||Mixed Models Analysis||The analysis using a MMRM analysis including a covariate of the corresponding score at baseline,fixed effects of time (as a categorical factor) and treatment and interaction between time and treatment group.|||2.74|-45.47|0.144
72336273|NCT01514240|144196084|SUPERIORITY_OR_OTHER||Difference of proportions|14.3|||||TWO_SIDED|90.0|0.5|27.4|||||90% CI calculated using the Newcombe-Wilson score method without continuity corrections.|||27.40|0.50|
72336274|NCT01514240|144196085|SUPERIORITY_OR_OTHER||Difference of proportions|16.1|||||TWO_SIDED|90.0|1.66|29.61|||||90% CI calculated using the Newcombe-Wilson score method without continuity corrections.|||29.61|1.66|
72336275|NCT01514240|144196086|SUPERIORITY_OR_OTHER||Difference of proportions|16.1|||||TWO_SIDED|90.0|0.85|30.29|||||90% CI calculated using the Newcombe-Wilson score method without continuity corrections.|||30.29|0.85|
72336276|NCT01514240|144196087|SUPERIORITY_OR_OTHER||Difference of proportions|7.1|||||TWO_SIDED|90.0|-5.67|19.71|||||90% CI calculated using the Newcombe-Wilson score method without continuity corrections.|||19.71|-5.67|
72336277|NCT01514240|144196088|SUPERIORITY_OR_OTHER||Difference of proportions|14.3|||||TWO_SIDED|90.0|0.5|27.4|||||90% CI calculated using the Newcombe-Wilson score method without continuity corrections.|||27.40|0.50|
72336278|NCT01514240|144196089|SUPERIORITY_OR_OTHER||Difference of proportions|12.5|||||TWO_SIDED|90.0|-2.44|26.68|||||90% CI calculated using the Newcombe-Wilson score method without continuity corrections.|||26.68|-2.44|
72336279|NCT01514240|144196090|SUPERIORITY_OR_OTHER||LS mean difference between group|10.5|STANDARD_ERROR_OF_MEAN|3.4|||TWO_SIDED|90.0|4.86|16.14|||||The analysis using a MMRM analysis including a covariate of the corresponding score at baseline,fixed effects of time (as a categorical factor) and treatment and interaction between time and treatment group.|||16.14|4.86|
72336280|NCT01514240|144196091|SUPERIORITY_OR_OTHER||LS mean difference between group|12.6|STANDARD_ERROR_OF_MEAN|3.93|||TWO_SIDED|90.0|6.07|19.11|||||The analysis using a MMRM analysis including a covariate of the corresponding score at baseline,fixed effects of time (as a categorical factor) and treatment and interaction between time and treatment group.|||19.11|6.07|
72336281|NCT01514240|144196092|SUPERIORITY_OR_OTHER||LS mean difference between group|12.6|STANDARD_ERROR_OF_MEAN|4.31|||TWO_SIDED|90.0|5.4|19.72|||||The analysis using a MMRM analysis including a covariate of the corresponding score at baseline,fixed effects of time (as a categorical factor) and treatment and interaction between time and treatment group.|||19.72|5.40|
72336282|NCT01514240|144196093|SUPERIORITY_OR_OTHER||LS mean difference between group|14.1|STANDARD_ERROR_OF_MEAN|4.32|||TWO_SIDED|90.0|6.9|21.23|||||The analysis using a MMRM analysis including a covariate of the corresponding score at baseline,fixed effects of time (as a categorical factor) and treatment and interaction between time and treatment group.|||21.23|6.90|
72336283|NCT01514240|144196094|SUPERIORITY_OR_OTHER||LS mean difference between group|3.4|STANDARD_ERROR_OF_MEAN|1.14|||TWO_SIDED|90.0|1.49|5.29|||||The analysis using a MMRM analysis including a covariate of the corresponding score at baseline,fixed effects of time (as a categorical factor) and treatment and interaction between time and treatment group.|||5.29|1.49|
72336284|NCT01514240|144196095|SUPERIORITY_OR_OTHER||LS mean difference between group|3.8|STANDARD_ERROR_OF_MEAN|1.31|||TWO_SIDED|90.0|1.64|5.97|||||The analysis using a MMRM analysis including a covariate of the corresponding score at baseline,fixed effects of time (as a categorical factor) and treatment and interaction between time and treatment group.|||5.97|1.64|
72336285|NCT01514240|144196096|SUPERIORITY_OR_OTHER||LS mean difference between group|4.1|STANDARD_ERROR_OF_MEAN|1.53|||TWO_SIDED|90.0|1.58|6.64|||||The analysis using a MMRM analysis including a covariate of the corresponding score at baseline,fixed effects of time (as a categorical factor) and treatment and interaction between time and treatment group.|||6.64|1.58|
72336286|NCT01514240|144196097|SUPERIORITY_OR_OTHER||LS mean difference between group|3.3|STANDARD_ERROR_OF_MEAN|1.47|||TWO_SIDED|90.0|0.9|5.76|||||The analysis using a MMRM analysis including a covariate of the corresponding score at baseline,fixed effects of time (as a categorical factor) and treatment and interaction between time and treatment group.|||5.76|0.90|
72336287|NCT01514240|144196098|SUPERIORITY_OR_OTHER||LS mean difference between group|2.0|STANDARD_ERROR_OF_MEAN|0.69|||TWO_SIDED|90.0|0.89|3.17|||||The analysis using a MMRM analysis including a covariate of the corresponding score at baseline,fixed effects of time (as a categorical factor) and treatment and interaction between time and treatment group.|||3.17|0.89|
72336288|NCT01514240|144196099|SUPERIORITY_OR_OTHER||LS mean difference between group|2.0|STANDARD_ERROR_OF_MEAN|0.74|||TWO_SIDED|90.0|0.73|3.19|||||The analysis using a MMRM analysis including a covariate of the corresponding score at baseline,fixed effects of time (as a categorical factor) and treatment and interaction between time and treatment group.|||3.19|0.73|
72336289|NCT01514240|144196100|SUPERIORITY_OR_OTHER||LS mean difference between group|2.4|STANDARD_ERROR_OF_MEAN|0.84|||TWO_SIDED|90.0|0.96|3.76|||||The analysis using a MMRM analysis including a covariate of the corresponding score at baseline,fixed effects of time (as a categorical factor) and treatment and interaction between time and treatment group.|||3.76|0.96|
72336290|NCT01514240|144196101|SUPERIORITY_OR_OTHER||LS mean difference between group|2.6|STANDARD_ERROR_OF_MEAN|0.89|||TWO_SIDED|90.0|1.15|4.09|||||The analysis using a MMRM analysis including a covariate of the corresponding score at baseline,fixed effects of time (as a categorical factor) and treatment and interaction between time and treatment group.|||4.09|1.15|
72336291|NCT01514240|144196102|SUPERIORITY_OR_OTHER||LS mean difference between group|3.8|STANDARD_ERROR_OF_MEAN|1.43|||TWO_SIDED|90.0|1.44|6.19|||||The analysis using a MMRM analysis including a covariate of the corresponding score at baseline,fixed effects of time (as a categorical factor) and treatment and interaction between time and treatment group.|||6.19|1.44|
72336292|NCT01514240|144196103|SUPERIORITY_OR_OTHER||LS mean difference between group|4.9|STANDARD_ERROR_OF_MEAN|1.66|||TWO_SIDED|90.0|2.14|7.65|||||The analysis using a MMRM analysis including a covariate of the corresponding score at baseline,fixed effects of time (as a categorical factor) and treatment and interaction between time and treatment group.|||7.65|2.14|
72336293|NCT01514240|144196104|SUPERIORITY_OR_OTHER||LS mean difference between group|4.3|STANDARD_ERROR_OF_MEAN|1.76|||TWO_SIDED|90.0|1.4|7.25|||||The analysis using a MMRM analysis including a covariate of the corresponding score at baseline,fixed effects of time (as a categorical factor) and treatment and interaction between time and treatment group.|||7.25|1.40|
72336294|NCT01514240|144196105|SUPERIORITY_OR_OTHER||LS mean difference between group|6.6|STANDARD_ERROR_OF_MEAN|1.86|||TWO_SIDED|90.0|3.56|9.72|||||The analysis using a MMRM analysis including a covariate of the corresponding score at baseline,fixed effects of time (as a categorical factor) and treatment and interaction between time and treatment group.|||9.72|3.56|
72336295|NCT01514240|144196106|SUPERIORITY_OR_OTHER||LS mean difference between group|1.2|STANDARD_ERROR_OF_MEAN|0.73|||TWO_SIDED|90.0|0.01|2.43|||||The analysis using a MMRM analysis including a covariate of the corresponding score at baseline,fixed effects of time (as a categorical factor) and treatment and interaction between time and treatment group.|||2.43|0.01|
72336296|NCT01514240|144196107|SUPERIORITY_OR_OTHER||LS mean difference between group|1.8|STANDARD_ERROR_OF_MEAN|0.81|||TWO_SIDED|90.0|0.42|3.12|||||The analysis using a MMRM analysis including a covariate of the corresponding score at baseline,fixed effects of time (as a categorical factor) and treatment and interaction between time and treatment group.|||3.12|0.42|
72336297|NCT01514240|144196108|SUPERIORITY_OR_OTHER||LS mean difference between group|1.6|STANDARD_ERROR_OF_MEAN|0.86|||TWO_SIDED|90.0|0.19|3.04|||||The analysis using a MMRM analysis including a covariate of the corresponding score at baseline,fixed effects of time (as a categorical factor) and treatment and interaction between time and treatment group.|||3.04|0.19|
72336298|NCT01514240|144196109|SUPERIORITY_OR_OTHER||LS mean difference between group|1.3|STANDARD_ERROR_OF_MEAN|0.85|||TWO_SIDED|90.0|-0.15|2.76|||||The analysis using a MMRM analysis including a covariate of the corresponding score at baseline,fixed effects of time (as a categorical factor) and treatment and interaction between time and treatment group.|||2.76|-0.15|
72336299|NCT00450294|144196110|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||That the means at the different timepoints would not all be equal.|ANOVA|||Repeated measures anova with post hoc t-tests using tukey's correction.||||<0.001
72336300|NCT00450294|144196111|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||That the means at the different timepoints would not all be equal.|ANOVA|||Repeated measures anova with post hoc t-tests using tukey's correction.||||<0.001
72336301|NCT01103063|144196112|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.11|STANDARD_DEVIATION|0.0647||0.12237|TWO_SIDED|95.0|0.97|1.25||Mantel-Haenszel estimate of the common relative risk is presented, adjusting for randomization strata. A relative risk less than 1 favors Azithromycin + Chloroquine treatment group (reduction in risk for the endpoint)|Mantel Haenszel||The estimated risk ratio is presented along with its standard error (SE), with the SE on the log(e) scale.|The 2-sided P-value tests the null hypothesis that the relative risk equals 1 (treatment group equality) versus not equal 1.||1.25|0.97|0.12237
72427247|NCT02500979|144366729|SUPERIORITY_OR_OTHER||Least squares mean difference|-21.5|STANDARD_ERROR_OF_MEAN|7.88||0.0118|TWO_SIDED|95.0|-37.8|-5.2|||Linear mixed-effects model|||||-5.2|-37.8|0.0118
72369723|NCT02930018|144249749|SUPERIORITY|It is hypothesized that the cleavage of nerinetide by plasmin which is activated by tissue plasminogen activators, such as alteplase results in a treatment modification of nerinetide in AIS patients with prior administration of alteplase as part of standard-of-care.|Odds Ratio (OR)|1.024||||0.866|TWO_SIDED|95.0|0.781|1.342||2 sided 0.05 significance level.|Regression, Logistic|||||1.342|0.781|0.866
72427248|NCT02500979|144366730|SUPERIORITY_OR_OTHER||LS mean difference (pramlintide-placebo)|-7.897||||0.0013|TWO_SIDED|95.0|-12.356|-3.438|||Linear mixed effects model|||||-3.438|-12.356|0.0013
72427249|NCT02500979|144366731|SUPERIORITY_OR_OTHER||LS mean difference (pramlintide-placebo)|-5.277||||0.0091|TWO_SIDED|95.0|-9.175|-1.378|||Linear mixed effects model|||||-1.378|-9.175|0.0091
72427250|NCT02500979|144366732|SUPERIORITY_OR_OTHER||LS mean difference (pramlintide-placebo)|-4.435||||0.0057|TWO_SIDED|95.0|-7.445|-1.424|||Linear mixed effects model|||||-1.424|-7.445|0.0057
72427251|NCT02500979|144366733|SUPERIORITY_OR_OTHER||Least squares mean difference|-28733.0|STANDARD_ERROR_OF_MEAN|4163.6|<|0.0001|TWO_SIDED|95.0|-37326.0|-20139.0|||Linear mixed-effects model|||||-20139|-37326|<0.0001
72427252|NCT02500979|144366734|SUPERIORITY_OR_OTHER||LS mean difference|-28.418||||0.0258|TWO_SIDED|95.0|-53.099|-3.737|||Linear mixed-effects model|||||-3.737|-53.099|0.0258
72427253|NCT02500979|144366736|SUPERIORITY_OR_OTHER||LS Mean Ratio (Pramlintide/Placebo)|1.31||||0.0456|TWO_SIDED|95.0|1.01|1.7|||Linear mixed-effects model|||||1.70|1.01|0.0456
72427254|NCT02500979|144366737|SUPERIORITY_OR_OTHER||LS mean ratio (pramlintide/placebo)|0.951||||0.1015|TWO_SIDED|95.0|0.896|1.011|||Linear mixed-effects model|||||1.011|0.896|0.1015
72427255|NCT02500979|144366739|SUPERIORITY_OR_OTHER||LS mean ratio (pramlintide/placebo)|1.085||||0.373|TWO_SIDED|95.0|0.901|1.307|||Linear mixed effects model|||||1.307|0.901|0.3730
72427256|NCT00672958|144366748|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.74||||0.407|TWO_SIDED|95.0|-2.48|1.01||Pre-specified sequential statistical testing procedure indicates that when p-value for change from baseline in HAMD-24 at Week 6 \>0.05, hierarchical testing stops and for subsequent endpoints in the sequence a nominal p-value is provided.|ANCOVA|Analysis of covariance (ANCOVA), with treatment and center as fixed factors and baseline HAM-D24 as a covariate.||Change from Baseline in HAM-D24 total score at Week 6 was tested at significance level 0.05. To control for multiplicity, subsequent endpoints were to be tested in a sequential testing procedure at significance level 0.025; as soon as an endpoint in a sequence was non-significant at 0.025, the testing procedure was stopped for all subsequent endpoints in that sequence.||1.01|-2.48|0.407
72427257|NCT00672958|144366749|SUPERIORITY_OR_OTHER||LS Mean Difference|0.07||||0.901|TWO_SIDED|95.0|-0.97|1.1|||ANCOVA|ANCOVA model with treatment and center as fixed factors and the baseline value as a covariate.||Comparison of change from Baseline at Week 1.||1.10|-0.97|0.901
72427258|NCT00672958|144366749|SUPERIORITY_OR_OTHER||LS Mean Difference|0.26||||0.701|TWO_SIDED|95.0|-1.07|1.59|||ANCOVA|ANCOVA model with treatment and center as fixed factors and the baseline value as a covariate.||Change from Baseline at Week 2||1.59|-1.07|0.701
72427259|NCT00672958|144366749|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.68||||0.356|TWO_SIDED|95.0|-2.11|0.76|||ANCOVA|ANCOVA model with treatment and center as fixed factors and the baseline value as a covariate.||Change from Baseline at Week 3||0.76|-2.11|0.356
72427260|NCT00672958|144366749|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.33||||0.67|TWO_SIDED|95.0|-1.85|1.19|||ANCOVA|ANCOVA model with treatment and center as fixed factors and the baseline value as a covariate.||Change from Baseline at Week 4||1.19|-1.85|0.670
72427261|NCT00672958|144366749|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.87||||0.304|TWO_SIDED|95.0|-2.52|0.79|||ANCOVA|ANCOVA model with treatment and center as fixed factors and the baseline value as a covariate.||Change from Baseline at Week 5||0.79|-2.52|0.304
72427262|NCT01380990|144366761|SUPERIORITY||Difference in percentages|0.0|||||TWO_SIDED|||||||||Percentage of patients alive at 1-year post-treatment in the historical control groups (without MRD) were compared to the percentage of study patients alive at 1-year post-treatment with OTL-101\* (on-study). Results are reported as percentage difference in OS of historical control group from OTL-101\* on-study subjects.||||
72427263|NCT01380990|144366761|SUPERIORITY||Difference in percentages|0.0|||||TWO_SIDED|||||||||Percentage of patients alive at 1-year post-treatment in the historical control groups (with MRD) were compared to the percentage of study patients alive at 1-year post-treatment with OTL-101\* (on-study). Results are reported as percentage difference in OS of historical control group from OTL-101\* on-study subjects.||||
72427264|NCT01380990|144366761|SUPERIORITY||Difference in percentages|0.0|||||TWO_SIDED|||||||||Percentage of patients alive at 1-year post-treatment in the historical control groups (all historical controls) were compared to the percentage of study patients alive at 1-year post-treatment with OTL-101\* (on-study). Results are reported as percentage difference in OS of historical control group from OTL-101\* on-study subjects.||||
72427265|NCT01380990|144366761|SUPERIORITY||Difference in percentages|0.0|||||TWO_SIDED|||||||||Percentage of patients alive at 1-year post-treatment in the historical control groups (without MRD) were compared to the percentage of patients alive at 1-year post-treatment with OTL-101\* (on-study and CUP). Results are reported as percentage difference in OS of historical control group from OTL-101\* on-study and CUP subjects.||||
72427266|NCT01380990|144366761|SUPERIORITY||Difference in percentages|0.0|||||TWO_SIDED|||||||||Percentage of patients alive at 1-year post-treatment in the historical control groups (with MRD) were compared to the percentage of patients alive at 1-year post-treatment with OTL-101\* (on-study and CUP). Results are reported as percentage difference in OS of historical control group from OTL-101\* on-study and CUP subjects.||||
72427267|NCT01380990|144366761|SUPERIORITY||Difference in percentages|0.0|||||TWO_SIDED|||||||||Percentage of patients alive at 1-year post-treatment in the historical control groups (all historical controls) were compared to the percentage of patients alive at 1-year post-treatment with OTL-101\* (on-study and CUP). Results are reported as percentage difference in OS of historical control group from OTL-101\* on-study and CUP subjects.||||
72427268|NCT01380990|144366762|SUPERIORITY||Difference in percentages|0.0|||||TWO_SIDED|||||||||Percentage of patients with EvFS at 1-year post-treatment in the historical control groups (without MRD) were compared to the percentage of study patients with EvFS at 1-year post-treatment with OTL-101\* (on-study). Results are reported as percentage difference in EvFS of historical control group from OTL-101\* on-study subjects.||||
72336302|NCT01103063|144196113|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.03|STANDARD_DEVIATION|0.1243||0.84117|TWO_SIDED|95.0|0.8|1.31||Mantel-Haenszel estimate of the common relative risk is presented, adjusting for randomization strata. A relative risk less than 1 favors Azithromycin + Chloroquine treatment group (reduction in risk for the endpoint)|Mantel Haenszel||The estimated risk ratio is presented along with its SE, with the SE on the log(e) scale.|The 2-sided P-value tests the null hypothesis that the relative risk equals 1 (treatment group equality) versus not equal 1.||1.31|0.80|0.84117
72336303|NCT01103063|144196114|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.87|STANDARD_DEVIATION|0.1745||0.4428|TWO_SIDED|95.0|0.62|1.23||Mantel-Haenszel estimate of the common relative risk is presented, adjusting for randomization strata. A relative risk less than 1 favors Azithromycin + Chloroquine treatment group (reduction in risk for the endpoint).|Mantel Haenszel||The estimated risk ratio is presented along with its standard error (SE), with the SE on the log(e) scale.|The 2-sided P-value tests the null hypothesis that the relative risk equals 1 (treatment group equality) versus not equal 1.||1.23|0.62|0.4428
72336304|NCT01103063|144196115|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.91|STANDARD_DEVIATION|0.1882||0.6086|TWO_SIDED|95.0|0.63|1.31||Mantel-Haenszel estimate of the common relative risk is presented, adjusting for randomization strata. A relative risk less than 1 favors Azithromycin + Chloroquine treatment group (reduction in risk for the endpoint).|Mantel Haenszel||The estimated risk ratio is presented along with its standard error (SE), with the SE on the log(e) scale.|The 2-sided P-value tests the null hypothesis that the relative risk equals 1 (treatment group equality) versus not equal 1.||1.31|0.63|0.6086
72336305|NCT01103063|144196116|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.9|STANDARD_DEVIATION|0.2866||0.7035|TWO_SIDED|95.0|0.51|1.57||Mantel-Haenszel estimate of the common relative risk is presented, adjusting for randomization strata. A relative risk less than 1 favors Azithromycin + Chloroquine treatment group (reduction in risk for the endpoint).|Mantel Haenszel||The estimated risk ratio is presented along with its standard error (SE), with the SE on the log(e) scale.|The 2-sided P-value tests the null hypothesis that the relative risk equals 1 (treatment group equality) versus not equal 1.||1.57|0.51|0.7035
72336306|NCT01103063|144196117|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.03|STANDARD_DEVIATION|0.04||0.4605|TWO_SIDED|95.0|0.95|1.11||Mantel-Haenszel estimate of the common relative risk is presented, adjusting for randomization strata. A relative risk less than 1 favors Azithromycin + Chloroquine treatment group (reduction in risk for the endpoint).|Mantel Haenszel||The estimated risk ratio is presented along with its standard error (SE), with the SE on the log(e) scale.|The 2-sided P-value tests the null hypothesis that the relative risk equals 1 (treatment group equality) versus not equal 1.||1.11|0.95|0.4605
72336307|NCT01103063|144196118|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.93|STANDARD_DEVIATION|0.1817||0.7105|TWO_SIDED|95.0|0.65|1.33||Mantel-Haenszel estimate of the common relative risk is presented, adjusting for randomization strata. A relative risk less than 1 favors Azithromycin + Chloroquine treatment group (reduction in risk for the endpoint).|Mantel Haenszel||The estimated risk ratio is presented along with its standard error (SE), with the SE on the log(e) scale.|The 2-sided P-value tests the null hypothesis that the relative risk equals 1 (treatment group equality) versus not equal 1.||1.33|0.65|0.7105
72336308|NCT01103063|144196119|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.84|STANDARD_DEVIATION|0.1842||0.3468|TWO_SIDED|95.0|0.59|1.21||Mantel-Haenszel estimate of the common relative risk is presented, adjusting for randomization strata. A relative risk less than 1 favors Azithromycin + Chloroquine treatment group (reduction in risk for the endpoint).|Mantel Haenszel||The estimated risk ratio is presented along with its standard error (SE), with the SE on the log(e) scale.|The 2-sided P-value tests the null hypothesis that the relative risk equals 1 (treatment group equality) versus not equal 1.||1.21|0.59|0.3468
72336309|NCT01103063|144196120|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.02||0.0011|TWO_SIDED|95.0|-0.08|-0.02||Analysis based on an ANOVA model with model terms for treatment group and randomization stratification variable. A negative mean difference between treatment groups favors Azithromycin + Chloroquine (reduction in number of STIs).|ANOVA|||The 2-sided P-value tests the null hypothesis that the mean difference is 0 (treatment group equality) versus not equal 0.||-0.02|-0.08|0.0011
72336310|NCT01103063|144196121|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.08|STANDARD_DEVIATION|0.0604||0.2265|TWO_SIDED|95.0|0.96|1.21||Mantel-Haenszel estimate of the common relative risk is presented, adjusting for randomization strata. A relative risk less than 1 favors Azithromycin + Chloroquine treatment group (reduction in risk for the endpoint).|Mantel Haenszel||The estimated risk ratio is presented along with its standard error (SE), with the SE on the log(e) scale.|The 2-sided P-value tests the null hypothesis that the relative risk equals 1 (treatment group equality) versus not equal 1.||1.21|0.96|0.2265
72336311|NCT01103063|144196122|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.14|STANDARD_ERROR_OF_MEAN|0.05||0.0131|TWO_SIDED|95.0|-0.24|-0.03||Analysis based on an ANCOVA model with model terms for baseline value, treatment group and randomization stratification variable.|ANCOVA|||The 2-sided P-value tests the null hypothesis that the mean difference is 0 (treatment group equality) versus not equal 0.||-0.03|-0.24|0.0131
72336312|NCT01103063|144196123|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.9|STANDARD_DEVIATION|0.2694||0.6978|TWO_SIDED|95.0|0.53|1.53||Mantel-Haenszel estimate of the common relative risk is presented, adjusting for randomization strata. A relative risk less than 1 favors Azithromycin + Chloroquine treatment group (reduction in risk for the endpoint).|Mantel Haenszel||The estimated risk ratio is presented along with its SE, with the SE on the log(e) scale.|The 2-sided P-value tests the null hypothesis that the relative risk equals 1 (treatment group equality) versus not equal 1.||1.53|0.53|0.6978
72336313|NCT01103063|144196124|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.14|STANDARD_DEVIATION|0.2908||0.6542|TWO_SIDED|95.0|0.64|2.01||Mantel-Haenszel estimate of the common relative risk is presented, adjusting for randomization strata. A relative risk less than 1 favors Azithromycin + Chloroquine treatment group (reduction in risk for the endpoint).|Mantel Haenszel||The estimated risk ratio is presented along with its SE, with the SE on the log(e) scale.|The 2-sided P-value tests the null hypothesis that the relative risk equals 1 (treatment group equality) versus not equal 1.||2.01|0.64|0.6542
72427269|NCT01380990|144366762|SUPERIORITY||Difference in percentages|0.0|||||TWO_SIDED|||||||||Percentage of patients with EvFS at 1-year post-treatment in the historical control groups (with MRD) were compared to the percentage of study patients with EvFS at 1-year post-treatment with OTL-101\* (on-study). Results are reported as percentage difference in EvFS of historical control group from OTL-101\* on-study subjects.||||
72427270|NCT01380990|144366762|SUPERIORITY||Difference in percentages|0.0|||||TWO_SIDED|||||||||Percentage of patients with EvFS at 1-year post-treatment in the historical control groups (all historical controls) were compared to the percentage of study patients with EvFS at 1-year post-treatment with OTL-101\* (on-study). Results are reported as percentage difference in EvFS of historical control group from OTL-101\* on-study subjects.||||
72427271|NCT01380990|144366762|SUPERIORITY||Difference in percentages|0.0|||||TWO_SIDED|||||||||Percentage of patients with EvFS at 1-year post-treatment in the historical control groups (without MRD) were compared to the percentage of study patients with EvFS at 1-year post-treatment with OTL-101\* (on-study and CUP). Results are reported as percentage difference in EvFS of historical control group from OTL-101\* on-study and CUP subjects.||||
72427272|NCT01380990|144366762|SUPERIORITY||Difference in percentages|0.0|||||TWO_SIDED|||||||||Percentage of patients with EvFS at 1-year post-treatment in the historical control groups (with MRD) were compared to the percentage of study patients with EvFS at 1-year post-treatment with OTL-101\* (on-study and CUP). Results are reported as percentage difference in EvFS of historical control group from OTL-101\* on-study and CUP subjects.||||
72336314|NCT01103063|144196125|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.1|STANDARD_ERROR_OF_MEAN|19.71||0.9145|TWO_SIDED|95.0|-36.5|40.8||Analysis based on an ANOVA model with model terms for treatment group and randomization stratification variable.|ANOVA|||The 2-sided P-value tests the null hypothesis that the mean difference is 0 (treatment group equality) versus not equal 0.||40.8|-36.5|0.9145
72336315|NCT01103063|144196126|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.07|STANDARD_ERROR_OF_MEAN|0.01|<|0.0001|TWO_SIDED|95.0|-0.09|-0.04||Analysis based on an ANOVA model with model terms for treatment group and randomization stratification variable. A negative mean difference between treatment groups favors Azithromycin + Chloroquine (reduction in number of symptomatic malaria).|ANOVA|||The 2-sided P-value tests the null hypothesis that the mean difference is 0 (treatment group equality) versus not equal 0.||-0.04|-0.09|<0.0001
72336316|NCT01103063|144196127|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.49|STANDARD_DEVIATION|0.1221|<|0.0001|TWO_SIDED|95.0|0.38|0.62||Mantel-Haenszel estimate of the common relative risk is presented, adjusting for randomization strata. A relative risk less than 1 favors Azithromycin + Chloroquine treatment group (reduction in risk for the endpoint).|Mantel Haenszel||The estimated risk ratio is presented along with its standard error (SE), with the SE on the log(e) scale.|The 2-sided P-value tests the null hypothesis that the relative risk equals 1 (treatment group equality) versus not equal 1.||0.62|0.38|<0.0001
72336317|NCT01103063|144196128|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.62|STANDARD_DEVIATION|0.2295||0.036|TWO_SIDED|95.0|0.39|0.97||Mantel-Haenszel estimate of the common relative risk is presented, adjusting for randomization strata. A relative risk less than 1 favors Azithromycin + Chloroquine treatment group (reduction in risk for the endpoint).|Mantel Haenszel||The estimated risk ratio is presented along with its SE, with the SE on the log(e) scale.|The 2-sided P-value tests the null hypothesis that the relative risk equals 1 (treatment group equality) versus not equal 1.||0.97|0.39|0.0360
72336318|NCT01103063|144196129|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.81|STANDARD_DEVIATION|0.163||0.1975|TWO_SIDED|95.0|0.59|1.12||Mantel-Haenszel estimate of the common relative risk is presented, adjusting for randomization strata. A relative risk less than 1 favors Azithromycin + Chloroquine treatment group (reduction in risk for the endpoint).|Mantel Haenszel||The estimated risk ratio is presented along with its standard error (SE), with the SE on the log(e) scale.|The 2-sided P-value tests the null hypothesis that the relative risk equals 1 (treatment group equality) versus not equal 1.||1.12|0.59|0.1975
72336319|NCT01103063|144196130|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.66|STANDARD_DEVIATION|0.5675||0.4655|TWO_SIDED|95.0|0.22|2.01||Mantel-Haenszel estimate of the common relative risk is presented, adjusting for randomization strata. A relative risk less than 1 favors Azithromycin + Chloroquine treatment group (reduction in risk for the endpoint).|Mantel Haenszel||The estimated risk ratio is presented along with its SE, with the SE on the log(e) scale.|The 2-sided P-value tests the null hypothesis that the relative risk equals 1 (treatment group equality) versus not equal 1.||2.01|0.22|0.4655
72427273|NCT01380990|144366762|SUPERIORITY||Difference in percentages|0.0|||||TWO_SIDED|||||||||Percentage of patients with EvFS at 1-year post-treatment in the historical control groups (all historical controls) were compared to the percentage of study patients with EvFS at 1-year post-treatment with OTL-101\* (on-study and CUP). Results are reported as percentage difference in EvFS of historical control group from OTL-101\* on-study and CUP subjects.||||
72427274|NCT01380990|144366767|OTHER|Model includes fixed effects for visit and Baseline, subject as random effect, with compound symmetry covariance structure. Observations with a value of 0 were imputed as 0.01. Model analyses log transformed data, so the adjusted mean refers to the geometric mean ratio between Month 12 and Baseline.|||||=|0.002|||||||Mixed Models Analysis|||"Mixed-Effect Model Repeated Measure (MMRM) Analysis of Change from Baseline to Month 12 in Log-Transformed CD3+ T Cell count (OTL-101\*) for OTL-101\* on-study subjects group."||||= 0.002
72336320|NCT01103063|144196131|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.75|STANDARD_DEVIATION|0.0918||0.0016|TWO_SIDED|95.0|0.62|0.9||Mantel-Haenszel estimate of the common relative risk is presented, adjusting for randomization strata. A relative risk less than 1 favors Azithromycin + Chloroquine treatment group (reduction in risk for the endpoint).|Mantel Haenszel||The estimated risk ratio is presented along with its standard error (SE), with the SE on the log(e) scale.|The 2-sided P-value tests the null hypothesis that the relative risk equals 1 (treatment group equality) versus not equal 1.||0.90|0.62|0.0016
72336321|NCT01103063|144196132|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|2.34|STANDARD_DEVIATION|0.5338||0.1113|TWO_SIDED|95.0|0.82|6.66||Mantel-Haenszel estimate of the common relative risk is presented, adjusting for randomization strata. A relative risk less than 1 favors Azithromycin + Chloroquine treatment group (reduction in risk for the endpoint).|Mantel Haenszel||The estimated risk ratio is presented along with its standard error (SE), with the SE on the log(e) scale.|The 2-sided P-value tests the null hypothesis that the relative risk equals 1 (treatment group equality) versus not equal 1.||6.66|0.82|0.1113
72427275|NCT01380990|144366767|OTHER|Model includes fixed effects for visit and Baseline, subject as random effect, with compound symmetry covariance structure. Observations with a value of 0 were imputed as 0.01. Model analyses log transformed data, so the adjusted mean refers to the geometric mean ratio between Month 12 and Baseline.|||||<|0.001|||||||Mixed Models Analysis|||"MMRM Analysis of Change from Baseline to Month 12 in Log-Transformed CD3+ T Cell count (OTL-101\*) for OTL-101\* on-study and CUP subjects group."||||< 0.001
72427276|NCT01380990|144366772|SUPERIORITY||Difference in percentages|0.0|||||TWO_SIDED|||||||||Percentage of patients with OS at 3-years post-treatment in the historical control groups (without MRD) were compared to the percentage of study patients with OS at 3-years post-treatment with OTL-101\* (on study). Results are reported as percentage difference in OS of historical control group from OTL-101\* on-study subjects.||||
72427277|NCT01380990|144366772|SUPERIORITY||Difference in percentages|11.11|||||TWO_SIDED|95.0|-22.41|48.25||||||Percentage of patients with OS at 3-years post-treatment in the historical control groups (with MRD) were compared to the percentage of study patients with OS at 3-years post-treatment with OTL-101\* (on study). Results are reported as percentage difference in OS of historical control group from OTL-101\* on-study subjects.||48.25|-22.41|
72427278|NCT01380990|144366772|SUPERIORITY||Difference in percentages|7.14|||||TWO_SIDED|95.0|-28.1|34.23||||||Percentage of patients with OS at 3-years post-treatment in the historical control groups (all historical controls) were compared to the percentage of study patients with OS at 3-years post-treatment with OTL-101\* (on study). Results are reported as percentage difference in OS of historical control group from OTL-101\* on-study subjects.||34.23|-28.10|
72427279|NCT01380990|144366772|SUPERIORITY||Difference in percentages|0.0|||||TWO_SIDED|||||||||Percentage of patients with OS at 3-years post-treatment in the historical control groups (without MRD) were compared to the percentage of study patients with OS at 3-years post-treatment with OTL-101\* (on study and CUP). Results are reported as percentage difference in OS of historical control group from OTL-101\* on-study and CUP subjects.||||
72427280|NCT01380990|144366772|SUPERIORITY||Difference in percentages|11.11|||||TWO_SIDED|95.0|-10.01|48.25||||||Percentage of patients with OS at 3-years post-treatment in the historical control groups (with MRD) were compared to the percentage of study patients with OS at 3-years post-treatment with OTL-101\* (on study and CUP). Results are reported as percentage difference in OS of historical control group from OTL-101\* on-study and CUP subjects.||48.25|-10.01|
72427281|NCT01380990|144366772|SUPERIORITY||Difference in percentages|7.14|||||TWO_SIDED|95.0|-12.91|33.87||||||Percentage of patients with OS at 3-years post-treatment in the historical control groups (all historical controls) were compared to the percentage of study patients with OS at 3-years post-treatment with OTL-101\* (on study and CUP). Results are reported as percentage difference in OS of historical control group from OTL-101\* on-study and CUP subjects.||33.87|-12.91|
72427282|NCT01380990|144366773|SUPERIORITY||||||=|0.645|||||||Log Rank|||||||=0.645
72427283|NCT01380990|144366773|SUPERIORITY||||||=|0.299|||||||Log Rank|||||||=0.299
72427284|NCT01380990|144366773|SUPERIORITY||||||=|0.2|||||||Log Rank|||||||= 0.2
72427285|NCT01380990|144366773|SUPERIORITY||||||=|0.028|||||||Log Rank|||||||= 0.028
72427286|NCT01380990|144366773|SUPERIORITY||||||=|0.259|||||||Log Rank|||||||= 0.259
72427287|NCT01380990|144366773|SUPERIORITY||||||=|0.044|||||||Log Rank|||||||= 0.044
72427288|NCT01380990|144366773|SUPERIORITY||Difference in percentages|10.0|||||TWO_SIDED|95.0|-32.05|61.97||||||Percentage of patients with EvFS at 3-years post-treatment in the historical control groups (without MRD) were compared to the percentage of study patients with EvFS at 3-years post-treatment with OTL-101\* (on-study). Results are reported as percentage difference in EvFS of historical control group from OTL-101\* on-study subjects.||61.97|-32.05|
72427289|NCT01380990|144366773|SUPERIORITY||Difference in percentages|30.0|||||TWO_SIDED|95.0|-10.72|65.87||||||Percentage of patients with EvFS at 3-years post-treatment in the historical control groups (with MRD) were compared to the percentage of study patients with EvFS at 3-years post treatment with OTL-101\* (on-study). Results are reported as percentage difference in EvFS of historical control group from OTL-101\* on-study subjects.||65.87|-10.72|
72427290|NCT01380990|144366773|SUPERIORITY||Difference in percentages|23.33|||||TWO_SIDED|95.0|-15.24|54.59||||||Percentage of patients with EvFS at 3-years post-treatment in the historical control groups (all historical controls) were compared to the percentage of study patients with EvFS at 3-years post-treatment with OTL-101\* (on-study). Results are reported as percentage difference in EvFS of historical control group from OTL-101\* on-study subjects.||54.59|-15.24|
72427291|NCT01380990|144366773|SUPERIORITY||Difference in percentages|15.0|||||TWO_SIDED|95.0|-13.7|63.54||||||Percentage of patients with EvFS at 3-years post-treatment in the historical control groups (without MRD) were compared to the percentage of study patients with EvFS at 3-years post-treatment with OTL-101\* (on-study and CUP). Results are reported as percentage difference in EvFS of historical control group from OTL-101\* on-study and CUP subjects.||63.54|-13.70|
72427292|NCT01380990|144366773|SUPERIORITY||Difference in percentages|35.0|||||TWO_SIDED|95.0|2.29|68.45||||||Percentage of patients with EvFS at 3-years post-treatment in the historical control groups (with MRD) were compared to the percentage of study patients with EvFS at 3-years post-treatment with OTL-101\* (on-study and CUP). Results are reported as percentage difference in EvFS of historical control group from OTL-101\* on-study and CUP subjects.||68.45|2.29|
72427293|NCT01380990|144366773|SUPERIORITY||Difference in percentages|28.33|||||TWO_SIDED|95.0|2.04|56.36||||||Percentage of patients with EvFS at 3-years post-treatment in the historical control groups (all historical controls) were compared to the percentage of study patients with EvFS at 3-years post-treatment with OTL-101\* (on-study and CUP). Results are reported as percentage difference in EvFS of historical control group from OTL-101\* on-study and CUP subjects.||56.36|2.04|
72427294|NCT04267614|144366781|OTHER||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
72427295|NCT04267614|144366782|OTHER||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
72427296|NCT04267614|144366783|OTHER||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
72427297|NCT04267614|144366784|OTHER||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
72427298|NCT04827134|144366785|OTHER||Ratio of Geometric Least Square Means|0.88|||||TWO_SIDED|90.0|0.8344|0.9282|||||An analysis of variance (ANOVA) was performed on parameter AUC(0-inf) for Analyte DTG to compare treatment arms Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed with Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted.|||0.9282|0.8344|
72427299|NCT04827134|144366785|OTHER||Ratio of Geometric Least Square Means|0.8578|||||TWO_SIDED|90.0|0.8168|0.9007|||||An analysis of variance was performed on parameter AUC(0-inf) for Analyte ABC to compare treatment arms Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed with Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted.|||0.9007|0.8168|
72427300|NCT04827134|144366785|OTHER||Ratio of Geometric Least Square Means|0.8919|||||TWO_SIDED|90.0|0.8316|0.9566|||||An analysis of variance was performed on parameter AUC(0-inf) for Analyte 3TC to compare treatment arms Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed with Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted.|||0.9566|0.8316|
72427301|NCT04827134|144366786|OTHER||Ratio of Geometric Least Square Means|0.8744|||||TWO_SIDED|90.0|0.8293|0.9219|||||An analysis of variance was performed on parameter AUC(0-t) for Analyte DTG to compare treatment arms Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed with Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted.|||0.9219|0.8293|
72427302|NCT04827134|144366786|OTHER||Ratio of Geometric Least Square Means|0.8567|||||TWO_SIDED|90.0|0.8159|0.8995|||||An analysis of variance was performed on parameter AUC(0-t) for Analyte ABC to compare treatment arms Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed with Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted.|||0.8995|0.8159|
72427303|NCT04827134|144366786|OTHER||Ratio of Geometric Least Square Means|0.8798|||||TWO_SIDED|90.0|0.8202|0.9438|||||An analysis of variance was performed on parameter AUC(0-t) for Analyte 3TC to compare treatment arms Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed with Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted.|||0.9438|0.8202|
72427304|NCT04827134|144366787|OTHER||Ratio of Geometric Least Square Means|0.7102|||||TWO_SIDED|90.0|0.6598|0.7643|||||An analysis of variance was performed on parameter Cmax for Analyte DTG to compare treatment arms Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed with Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted.|||0.7643|0.6598|
72427305|NCT04827134|144366787|OTHER||Ratio of Geometric Least Square Means|0.4503|||||TWO_SIDED|90.0|0.3976|0.51|||||An analysis of variance was performed on parameter Cmax for Analyte ABC to compare treatment arms Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed with Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted.|||0.5100|0.3976|
72427306|NCT04827134|144366787|OTHER||Ratio of Geometric Least Square Means|0.6373|||||TWO_SIDED|90.0|0.5594|0.726|||||An analysis of variance was performed on parameter Cmax for Analyte 3TC to compare treatment arms Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed with Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted.|||0.7260|0.5594|
72427307|NCT04827134|144366788|OTHER||Ratio of Geometric Least Square Means|0.9148|||||TWO_SIDED|90.0|0.8834|0.9472|||||An analysis of variance was performed on parameter AUC(0-inf) for Analyte DTG to compare treatment arms Cohort 2: DOVATO (DTG/3TC) Fed with Cohort 2: DOVATO (DTG/3TC) Fasted.|||0.9472|0.8834|
72427308|NCT04827134|144366788|OTHER||Ratio of Geometric Least Square Means|0.8847|||||TWO_SIDED|90.0|0.8303|0.9426|||||An analysis of variance was performed on parameter AUC(0-inf) for Analyte 3TC to compare treatment arms Cohort 2: DOVATO (DTG/3TC) Fed with Cohort 2: DOVATO (DTG/3TC) Fasted.|||0.9426|0.8303|
72427309|NCT04827134|144366789|OTHER||Ratio of Geometric Least Square Means|0.9163|||||TWO_SIDED|90.0|0.8862|0.9475|||||An analysis of variance was performed on parameter AUC(0-t) for Analyte DTG to compare treatment arms Cohort 2: DOVATO (DTG/3TC) Fed with Cohort 2: DOVATO (DTG/3TC) Fasted.|||0.9475|0.8862|
72427310|NCT04827134|144366789|OTHER||Ratio of Geometric Least Square Means|0.8806|||||TWO_SIDED|90.0|0.8251|0.9398|||||An analysis of variance was performed on parameter AUC(0-t) for Analyte 3TC to compare treatment arms Cohort 2: DOVATO (DTG/3TC) Fed with Cohort 2: DOVATO (DTG/3TC) Fasted.|||0.9398|0.8251|
72427311|NCT04827134|144366790|OTHER||Ratio of Geometric Least Square Means|0.7284|||||TWO_SIDED|90.0|0.6576|0.8068|||||An analysis of variance was performed on parameter Cmax for Analyte DTG to compare treatment arms Cohort 2: DOVATO (DTG/3TC) Fed with Cohort 2: DOVATO (DTG/3TC) Fasted.|||0.8068|0.6576|
72427312|NCT04827134|144366790|OTHER||Ratio of Geometric Least Square Means|0.5191|||||TWO_SIDED|90.0|0.4535|0.5943|||||An analysis of variance was performed on parameter Cmax for Analyte 3TC to compare treatment arms Cohort 2: DOVATO (DTG/3TC) Fed with Cohort 2: DOVATO (DTG/3TC) Fasted.|||0.5943|0.4535|
72427313|NCT00988351|144366837|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin -0.55 (mean hours of APAP arm no lower than 0.55 hours below CPAP arm)|Mean Difference (Final Values)|0.46|STANDARD_ERROR_OF_MEAN|0.4|=|0.27|TWO_SIDED|95.0|-0.35|1.26||level of significance \<0.05, Power = 0.80|t-test, 2 sided|||||1.26|-.35|= 0.27
72427314|NCT00988351|144366838|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.4|||=|0.65|TWO_SIDED|95.0|-1.3|2.1|||t-test, 2 sided|||Patients using PAP (average of \>=1/2 hour per night) at 6 weeks clinic visit||2.1|-1.3|= 0.65
72427315|NCT00988351|144366839|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.69|STANDARD_ERROR_OF_MEAN|0.71|=|0.33|TWO_SIDED|95.0|-0.73|2.1||\< 0.05 criteria for statistical significance|t-test, 2 sided|||Patients using PAP (average \>=1/2 hour per nightly use) at 6 weeks clinic visit||2.1|-0.73|=0.33
72427316|NCT00988351|144366840|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.58|||=|0.49|TWO_SIDED|95.0|-1.12|2.29|||t-test, 2 sided|||Patients using PAP (average \>= 1/2 hour of nightly use) at 6 weeks clinic visit||2.29|-1.12|=0.49
72427317|NCT00988351|144366841|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.51|=|0.07|TWO_SIDED|95.0|-1.92|0.09||P \< 0.05 considered statistically significant|t-test, 2 sided|||participants using PAP (average \>=1/2 hour of use) at 6 weeks clinic visit||0.09|-1.92|=0.07
72427318|NCT00183456|144366846|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.28|||<|0.01|TWO_SIDED|95.0|0.13|0.63|||Generalized Estimating Equations|||||0.63|0.13|<0.01
72427319|NCT00183456|144366847|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.68||||0.05|TWO_SIDED|95.0|1.22|5.89|||Generalized Estimating Equations|||||5.89|1.22|0.05
72427320|NCT00183456|144366848|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.36||||0.05|TWO_SIDED|95.0|0.16|0.84|||Generalized Estimating Equations|||||0.84|0.16|0.05
72427321|NCT00183456|144366849|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.82||||0.01|TWO_SIDED|95.0|1.41|5.64|||Generalized Estimating Equations|||||5.64|1.41|0.01
72427322|NCT00183456|144366850|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.24||||0.01|TWO_SIDED|95.0|0.09|0.68|||Generalized Estimating Equations|||||0.68|0.09|0.01
72427323|NCT00183456|144366851|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.47||||0.05|TWO_SIDED|95.0|0.25|0.87|||Generalized Estimating Equations|||||0.87|0.25|0.05
72427324|NCT00183456|144366852|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.41||||0.01|TWO_SIDED|95.0|0.21|0.77|||Generalized Estimating Equations|||||0.77|0.21|0.01
72427325|NCT00183456|144366853|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.33||||0.05|TWO_SIDED|95.0|0.14|0.79|||Generalized Estimating Equations|||||0.79|0.14|0.05
72427326|NCT00183456|144366854|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.3||||0.01|TWO_SIDED|95.0|0.14|0.64|||Generalized Estimating Equations|||||0.64|0.14|0.01
72427327|NCT00183456|144366855|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.41||||0.01|TWO_SIDED|95.0|1.25|4.65|||Generalized Estimating Equations|||||4.65|1.25|0.01
72427328|NCT02731313|144366856|NON_INFERIORITY_OR_EQUIVALENCE|Null hypothesis (H0): kappa coefficient = 0.90||||||0.7436|||||||Kappa-test p-value, 2 sided|||Rationale for the determination of the number of samples:The following hypotheses were considered: two-sided risk alpha = 5%, power (1 - beta) = 90%, a success rate (rate of positive HER-2 status) = 17%, null hypothesis (H0): kappa coefficient = 0.90. 359 samples would allow determining a first estimate of the 0.90 coefficient of correlation kappa. The total number of samples, which had to be included in this study was 395, considering a 10% rate of non-evaluable samples.||||0.7436
72427329|NCT03881059|144366895|SUPERIORITY||Slope Coefficient of Dose|0.11|||<|0.001|TWO_SIDED|95.0|0.05|0.17|||Regression, Logistic|||||0.17|0.05|<0.001
72427330|NCT02065570|144366939|SUPERIORITY||Adjusted risk difference|0.3||||0.939|TWO_SIDED|95.0|-8.1|8.8||Adjusted for previous infliximab use (or prior anti-tumor necrosis factor (TNF) use for participants randomized under original protocol), hs-CRP at Baseline (\<10 mg/L, \>=10 mg/L) and Crohn's disease severity at Baseline (CDAI ≤ 300, CDAI \> 300).|Cochran-Mantel-Haenszel||Risk difference = (adalimumab higher induction dose - adalimumab standard induction dose).|||8.8|-8.1|0.939
72427331|NCT02065570|144366940|SUPERIORITY||Adjusted risk difference|3.2||||0.462|TWO_SIDED|95.0|-5.3|11.7||Adjusted for previous infliximab use (or prior anti-TNF use for participants randomized under original protocol), hs-CRP at Baseline (\<10 mg/L, \>=10 mg/L) and Crohn's disease severity at Baseline (CDAI ≤ 300, CDAI \> 300).|Cochran-Mantel-Haenszel||Risk difference = (adalimumab higher induction dose - adalimumab standard induction dose).|||11.7|-5.3|0.462
72427332|NCT02065570|144366942|SUPERIORITY||Adjusted risk difference|4.6||||0.269|TWO_SIDED|95.0|-3.6|12.8||Adjusted for previous infliximab use (or prior anti-TNF use for participants randomized under original protocol), hs-CRP at Baseline (\<10 mg/L, \>=10 mg/L) and Crohn's disease severity at Baseline (CDAI ≤ 300, CDAI \> 300).|Cochran-Mantel-Haenszel||Risk difference = (adalimumab higher induction dose - adalimumab standard induction dose).|||12.8|-3.6|0.269
72427333|NCT02065570|144366943|SUPERIORITY||Adjusted risk difference|1.8||||0.61|TWO_SIDED|95.0|-5.1|8.7||Adjusted for previous infliximab use (or prior anti-TNF use for participants randomized under original protocol), hs-CRP at Baseline (\<10 mg/L, \>=10 mg/L) and Crohn's disease severity at Baseline (CDAI ≤ 300, CDAI \> 300).|Cochran-Mantel-Haenszel||Risk difference = (adalimumab higher induction dose - adalimumab standard induction dose).|||8.7|-5.1|0.610
72427334|NCT02065570|144366944|SUPERIORITY||Adjusted risk difference|11.2||||0.008|TWO_SIDED|95.0|2.9|19.6||Adjusted for previous infliximab use (or prior anti-TNF use for participants randomized under original protocol), hs-CRP at Baseline (\<10 mg/L, \>=10 mg/L) and Crohn's disease severity at Baseline (CDAI ≤ 300, CDAI \> 300).|Cochran-Mantel-Haenszel||Risk difference = (adalimumab higher induction dose - adalimumab standard induction dose).|||19.6|2.9|0.008
72427335|NCT02065570|144366945|SUPERIORITY||Adjusted risk difference|6.0||||0.336|TWO_SIDED|95.0|-6.2|18.2||Adjusted for previous infliximab use (or prior anti-TNF use for participants randomized under original protocol), hs-CRP at Baseline (\<10 mg/L, \>=10 mg/L) and Crohn's disease severity at Baseline (CDAI ≤ 300, CDAI \> 300).|Cochran-Mantel-Haenszel||Risk difference = (adalimumab higher induction dose - adalimumab standard induction dose).|||18.2|-6.2|0.336
72427336|NCT02065570|144366946|SUPERIORITY||Adjusted risk difference|1.5||||0.694|TWO_SIDED|95.0|-6.1|9.1||Adjusted for previous infliximab use (or prior anti-TNF use for participants randomized under original protocol), hs-CRP at Baseline (\<10 mg/L, \>=10 mg/L) and Crohn's disease severity at Baseline (CDAI ≤ 300, CDAI \> 300).|Cochran-Mantel-Haenszel||Risk difference = (adalimumab higher induction dose - adalimumab standard induction dose).|||9.1|-6.1|0.694
72427337|NCT02065570|144366947|SUPERIORITY||LS Mean of Difference|6.8||||0.946|TWO_SIDED|95.0|-192.3|205.9|||Cochran-Mantel-Haenszel|||||205.9|-192.3|0.946
72427338|NCT02065570|144366948|SUPERIORITY||Adjusted risk difference|4.0||||0.293|TWO_SIDED|95.0|-3.5|11.5||Adjusted for previous infliximab use (or prior anti-TNF use for participants randomized under original protocol), hs-CRP at Baseline (\<10 mg/L, \>=10 mg/L) and Crohn's disease severity at Baseline (CDAI ≤ 300, CDAI \> 300).|Cochran-Mantel-Haenszel||Risk difference = (adalimumab higher induction dose - adalimumab standard induction dose).|||11.5|-3.5|0.293
72427339|NCT02065570|144366949|SUPERIORITY||Adjusted risk difference|3.0||||0.304|TWO_SIDED|95.0|-2.7|8.6||Adjusted for previous infliximab use (or prior anti-TNF use for participants randomized under original protocol), hs-CRP at Baseline (\<10 mg/L, \>=10 mg/L) and Crohn's disease severity at Baseline (CDAI ≤ 300, CDAI \> 300).|Cochran-Mantel-Haenszel||Risk difference = (adalimumab higher induction dose - adalimumab standard induction dose).|||8.6|-2.7|0.304
72427340|NCT02065570|144366950|SUPERIORITY||Adjusted risk difference|4.2||||0.092|TWO_SIDED|95.0|-0.7|9.1||Adjusted for previous infliximab use (or prior anti-TNF use for participants randomized under original protocol), hs-CRP at Baseline (\<10 mg/L, \>=10 mg/L) and Crohn's disease severity at Baseline (CDAI ≤ 300, CDAI \> 300).|Cochran-Mantel-Haenszel||Risk difference = (adalimumab higher induction dose - adalimumab standard induction dose).|||9.1|-0.7|0.092
72427341|NCT02065570|144366951|SUPERIORITY||Adjusted risk difference|3.6||||0.278|TWO_SIDED|95.0|-2.9|10.2||Adjusted for previous infliximab use (or prior anti-TNF use for participants randomized under original protocol), hs-CRP at Baseline (\<10 mg/L, \>=10 mg/L) and Crohn's disease severity at Baseline (CDAI ≤ 300, CDAI \> 300).|Cochran-Mantel-Haenszel||Risk difference = (adalimumab higher induction dose - adalimumab standard induction dose).|||10.2|-2.9|0.278
72427342|NCT02065570|144366952|SUPERIORITY||Adjusted risk difference|3.7||||0.353|TWO_SIDED|95.0|-4.1|11.5||Adjusted for previous infliximab use (or prior anti-TNF use for participants randomized under original protocol), hs-CRP at Baseline (\<10 mg/L, \>=10 mg/L) and Crohn's disease severity at Baseline (CDAI ≤ 300, CDAI \> 300).|Cochran-Mantel-Haenszel||Risk difference = (adalimumab higher induction dose - adalimumab standard induction dose).|||11.5|-4.1|0.353
72427343|NCT02065570|144366953|SUPERIORITY||Adjusted risk difference|8.9||||0.015|TWO_SIDED|95.0|1.8|16.0||Adjusted for previous infliximab use (or prior anti-TNF use for participants randomized under original protocol), hs-CRP at Baseline (\<10 mg/L, \>=10 mg/L) and Crohn's disease severity at Baseline (CDAI ≤ 300, CDAI \> 300).|Cochran-Mantel-Haenszel||Risk difference = (adalimumab higher induction dose - adalimumab standard induction dose).|||16.0|1.8|0.015
72336322|NCT01103063|144196133|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.25|STANDARD_DEVIATION|0.6386||0.0284|TWO_SIDED|95.0|0.07|0.86||Mantel-Haenszel estimate of the common relative risk is presented, adjusting for randomization strata. A relative risk less than 1 favors Azithromycin + Chloroquine treatment group (reduction in risk for the endpoint).|Mantel Haenszel||The estimated risk ratio is presented along with its standard error (SE), with the SE on the log(e) scale.|The 2-sided P-value tests the null hypothesis that the relative risk equals 1 (treatment group equality) versus not equal 1.||0.86|0.07|0.0284
72336323|NCT01103063|144196134|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.46|STANDARD_DEVIATION|0.3291||0.0188|TWO_SIDED|95.0|0.24|0.88||Mantel-Haenszel estimate of the common relative risk is presented, adjusting for randomization strata. A relative risk less than 1 favors Azithromycin + Chloroquine treatment group (reduction in risk for the endpoint).|Mantel Haenszel||The estimated risk ratio is presented along with its standard error (SE), with the SE on the log(e) scale.|The 2-sided P-value tests the null hypothesis that the relative risk equals 1 (treatment group equality) versus not equal 1.||0.88|0.24|0.0188
72336324|NCT01103063|144196135|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.77|STANDARD_DEVIATION|0.1336||0.0527|TWO_SIDED|95.0|0.59|1.0||Mantel-Haenszel estimate of the common relative risk is presented, adjusting for randomization strata. A relative risk less than 1 favors Azithromycin + Chloroquine treatment group (reduction in risk for the endpoint).|Mantel Haenszel||The estimated risk ratio is presented along with its standard error (SE), with the SE on the log(e) scale.|The 2-sided P-value tests the null hypothesis that the relative risk equals 1 (treatment group equality) versus not equal 1.||1.00|0.59|0.0527
72336325|NCT01103063|144196136|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.73|STANDARD_DEVIATION|0.1536||0.0384|TWO_SIDED|95.0|0.54|0.98||Mantel-Haenszel estimate of the common relative risk is presented, adjusting for randomization strata. A relative risk less than 1 favors Azithromycin + Chloroquine treatment group (reduction in risk for the endpoint).|Mantel Haenszel||The estimated risk ratio is presented along with its standard error (SE), with the SE on the log(e) scale.|The 2-sided P-value tests the null hypothesis that the relative risk equals 1 (treatment group equality) versus not equal 1.||0.98|0.54|0.0384
72336326|NCT01103063|144196137|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|2.09|STANDARD_DEVIATION|0.8648||0.3942|TWO_SIDED|95.0|0.38|11.38||Mantel-Haenszel estimate of the common relative risk is presented, adjusting for randomization strata. A relative risk less than 1 favors Azithromycin + Chloroquine treatment group (reduction in risk for the endpoint).|Mantel Haenszel||The estimated risk ratio is presented along with its standard error (SE), with the SE on the log(e) scale.|The 2-sided P-value tests the null hypothesis that the relative risk equals 1 (treatment group equality) versus not equal 1.||11.38|0.38|0.3942
72336327|NCT01103063|144196138|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.39|STANDARD_DEVIATION|0.4439||0.0332|TWO_SIDED|95.0|0.16|0.93||Mantel-Haenszel estimate of the common relative risk is presented, adjusting for randomization strata. A relative risk less than 1 favors Azithromycin + Chloroquine treatment group (reduction in risk for the endpoint).|Mantel Haenszel||The estimated risk ratio is presented along with its standard error (SE), with the SE on the log(e) scale.|The 2-sided P-value tests the null hypothesis that the relative risk equals 1 (treatment group equality) versus not equal 1.||0.93|0.16|0.0332
72336328|NCT01103063|144196139|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.61|STANDARD_DEVIATION|0.4195||0.2321|TWO_SIDED|95.0|0.27|1.38||Mantel-Haenszel estimate of the common relative risk is presented, adjusting for randomization strata. A relative risk less than 1 favors Azithromycin + Chloroquine treatment group (reduction in risk for the endpoint).|Mantel Haenszel||The estimated risk ratio is presented along with its standard error (SE), with the SE on the log(e) scale.|The 2-sided P-value tests the null hypothesis that the relative risk equals 1 (treatment group equality) versus not equal 1.||1.38|0.27|0.2321
72427344|NCT02065570|144366954|SUPERIORITY||Adjusted risk difference|3.4||||0.394|TWO_SIDED|95.0|-4.4|11.1||Adjusted for previous infliximab use (or prior anti-TNF use for participants randomized under original protocol), hs-CRP at Baseline (\<10 mg/L, \>=10 mg/L) and Crohn's disease severity at Baseline (CDAI ≤ 300, CDAI \> 300).|Cochran-Mantel-Haenszel||Risk difference = (adalimumab higher induction dose - adalimumab standard induction dose).|||11.1|-4.4|0.394
72336329|NCT01103063|144196140|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.76||||1|TWO_SIDED||||||Fisher Exact|||Statistical analysis for Visit 6 presented above.||||1.0000
72336330|NCT01103063|144196140|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||1|TWO_SIDED||||||Fisher Exact|||Statistical analysis for Visit 7 presented above.||||1.0000
72336331|NCT01103063|144196141|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||1|TWO_SIDED||||||Fisher Exact|||Statistical analysis for Visit 6 presented above.||||1.0000
72336332|NCT01103063|144196141|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||1|TWO_SIDED||||||Fisher Exact|||Statistical analysis for Visit 7 presented above.||||1.0000
72336333|NCT01437098|144196147|SUPERIORITY_OR_OTHER||Proportion of IF Implanted Subjects|91.7|||<|0.001|TWO_SIDED|95.0|77.5|98.2|||Exact binomial|||||98.2|77.5|<0.001
72336334|NCT00252694|144196208|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.87||||0.1994|TWO_SIDED|95.0|0.704|1.076|||Log Rank|Generalized||||1.076|0.704|0.1994
72336335|NCT02868034|144196222|SUPERIORITY||Mean Difference (Final Values)|-0.02||||0.025|TWO_SIDED|97.5|-0.26|0.22|||Mixed Models Analysis|Consistent with the randomized design, mean values for the Phase II baseline were constrained to be equal to a common overall mean.|A negative value indicates greater reduction in stiffness when the component was used|SMT Component Main Effects at 4 weeks||0.22|-0.26|0.025
72427345|NCT02065570|144366955|SUPERIORITY||Adjusted risk difference|3.6||||0.349|TWO_SIDED|95.0|-4.0|11.2||Adjusted for previous infliximab use (or prior anti-TNF use for participants randomized under original protocol), hs-CRP at Baseline (\<10 mg/L, \>=10 mg/L) and Crohn's disease severity at Baseline (CDAI ≤ 300, CDAI \> 300).|Cochran-Mantel-Haenszel||Risk difference = (adalimumab higher induction dose - adalimumab standard induction dose)|||11.2|-4.0|0.349
72427346|NCT02065570|144366956|SUPERIORITY||Adjusted risk difference|7.6||||0.054|TWO_SIDED|95.0|-0.1|15.3||Adjusted for previous infliximab use (or prior anti-TNF use for participants randomized under original protocol), hs-CRP at Baseline (\<10 mg/L, \>=10 mg/L) and Crohn's disease severity at Baseline (CDAI ≤ 300, CDAI \> 300).|Cochran-Mantel-Haenszel||Risk difference = (adalimumab higher induction dose - adalimumab standard induction dose)|||15.3|-0.1|0.054
72427347|NCT02293837|144366994|SUPERIORITY|||||||0.277||||||P-value comes from an analysis of covariance with outcome variable of change in mAUC from screening and covariates of treatment, screening mAUC, and age.|ANCOVA|||Week 52; Primary imputation method used for missing Week 52 mAUC.||||0.277
72427348|NCT02293837|144366995|SUPERIORITY|||||||0.499||||||P-value comes from an analysis of covariance with outcome variable of change in mAUC from screening and covariates of treatment, screening mAUC, and age.|ANCOVA|||Week 24||||0.499
72427349|NCT02293837|144366995|SUPERIORITY|||||||0.267||||||P-value comes from an analysis of covariance with outcome variable of change in mAUC from screening and covariates of treatment, screening mAUC, and age.|ANCOVA|||Week 52||||0.267
72427350|NCT02293837|144366995|SUPERIORITY|||||||0.226||||||P-value comes from an analysis of covariance with outcome variable of change in mAUC from screening and covariates of treatment, screening mAUC, and age.|ANCOVA|||Week 104||||0.226
72427351|NCT02293837|144366995|SUPERIORITY|||||||0.758||||||P-value comes from an analysis of covariance with outcome variable of change in mAUC from screening and covariates of treatment, screening mAUC, and age.|ANCOVA|||Week 24||||0.758
72427352|NCT02293837|144366995|SUPERIORITY|||||||0.341||||||P-value comes from an analysis of covariance with outcome variable of change in mAUC from screening and covariates of treatment, screening mAUC, and age.|ANCOVA|||Week 52||||0.341
72427353|NCT02293837|144366995|SUPERIORITY|||||||0.969||||||P-value comes from an analysis of covariance with outcome variable of change in mAUC from screening and covariates of treatment, screening mAUC, and age.|ANCOVA|||Week 104||||0.969
72427354|NCT02293837|144366995|SUPERIORITY|||||||0.689||||||P-value comes from an analysis of covariance with outcome variable of change in mAUC from screening and covariates of treatment, screening mAUC, and age.|ANCOVA|||Week 24||||0.689
72427355|NCT02293837|144366995|SUPERIORITY|||||||0.4||||||P-value comes from an analysis of covariance with outcome variable of change in mAUC from screening and covariates of treatment, screening mAUC, and age.|ANCOVA|||Week 52||||0.400
72427356|NCT02293837|144366995|SUPERIORITY|||||||0.969||||||P-value comes from an analysis of covariance with outcome variable of change in mAUC from screening and covariates of treatment, screening mAUC, and age.|ANCOVA|||Week 104||||0.969
72427357|NCT02293837|144366996|SUPERIORITY|||||||0.679||||||P-value is for group difference in time trends from a longitudinal mixed effects model. Response variable was 2-hour C-peptide mAUC and covariates were treatment, study week, age, treatment\*study week, age\*study week.|Longitudinal mixed model|Random within-subject effects for intercept and study week were included assuming an unstructured covariance matrix.||Screening to Week 104||||0.679
72427358|NCT02293837|144366996|SUPERIORITY|||||||0.373||||||P-value is for group difference in time trends from a longitudinal mixed effects model. Response variable was 2-hour C-peptide mAUC and covariates were treatment, study week, age, treatment\*study week, age\*study week.|Longitudinal mixed model|Random within-subject effects for intercept and study week were included assuming an unstructured covariance matrix.||Screening to Week 104||||0.373
72427359|NCT02293837|144366996|SUPERIORITY|||||||0.395||||||P-value is for group difference in time trends from a longitudinal mixed effects model. Response variable was 2-hour C-peptide mAUC and covariates were treatment, study week, age, treatment\*study week, age\*study week.|Longitudinal mixed model|Random within-subject effects for intercept and study week were included assuming an unstructured covariance matrix.||Screening to Week 104||||0.395
72427360|NCT02293837|144366997|SUPERIORITY|||||||0.176||||||P-value comes from an analysis of covariance with outcome variable of change in mAUC from screening and covariates of treatment, screening mAUC, and age.|ANCOVA|||Week 52. Only participants \>=12 years old had the 4-hour MMTT performed.||||0.176
72427361|NCT02293837|144366997|SUPERIORITY|||||||0.285||||||P-value comes from an analysis of covariance with outcome variable of change in mAUC from screening and covariates of treatment, screening mAUC, and age.|ANCOVA|||Week 104. Only participants \>=12 years old had the 4-hour MMTT performed.||||0.285
72427362|NCT02293837|144366997|SUPERIORITY|||||||0.435||||||P-value comes from an analysis of covariance with outcome variable of change in mAUC from screening and covariates of treatment, screening mAUC, and age.|ANCOVA|||Week 52||||0.435
72427363|NCT02293837|144366997|SUPERIORITY|||||||0.931||||||P-value comes from an analysis of covariance with outcome variable of change in mAUC from screening and covariates of treatment, screening mAUC, and age.|ANCOVA|||Week 104||||0.931
72427364|NCT02293837|144366997|SUPERIORITY|||||||0.28||||||P-value comes from an analysis of covariance with outcome variable of change in mAUC from screening and covariates of treatment, screening mAUC, and age.|ANCOVA|||Week 52. Only participants \>=12 years old had the 4-hour MMTT performed.||||0.280
72427365|NCT02293837|144366997|SUPERIORITY|||||||0.985||||||P-value comes from an analysis of covariance with outcome variable of change in mAUC from screening and covariates of treatment, screening mAUC, and age.|ANCOVA|||Week 104. Only participants \>=12 years old had the 4-hour MMTT performed.||||0.985
72427366|NCT02293837|144366998|SUPERIORITY|||||||0.762||||||P-value comes from an analysis of covariance with outcome variable of change in average insulin use per kg from baseline and covariates of treatment, baseline average insulin use per kg, and age.|ANCOVA|||Week 24||||0.762
72427367|NCT02293837|144366998|SUPERIORITY|||||||0.64||||||P-value comes from an analysis of covariance with outcome variable of change in average insulin use per kg from baseline and covariates of treatment, baseline average insulin use per kg, and age.|ANCOVA|||Week 52||||0.640
72427368|NCT02293837|144366998|SUPERIORITY|||||||0.145||||||P-value comes from an analysis of covariance with outcome variable of change in avg insulin use per kg from baseline and covariates of treatment, baseline average insulin use per kg, and age.|ANCOVA|||Week 104||||0.145
72427369|NCT02293837|144366998|SUPERIORITY|||||||0.033||||||P-value comes from an analysis of covariance with outcome variable of change in average insulin use per kg from baseline and covariates of treatment, baseline average insulin use per kg, and age.|ANCOVA|||Week 24||||0.033
72427370|NCT02293837|144366998|SUPERIORITY|||||||0.591||||||P-value comes from an analysis of covariance with outcome variable of change in avg insulin use per kg from baseline and covariates of treatment, baseline avg insulin use per kg, and age.|ANCOVA|||Week 52||||0.591
72427371|NCT02293837|144366998|SUPERIORITY|||||||0.81||||||P-value comes from an analysis of covariance with outcome variable of change in average insulin use per kg from baseline and covariates of treatment, baseline average insulin use per kg, and age.|ANCOVA|||Week 104||||0.810
72427372|NCT02293837|144366998|SUPERIORITY|||||||0.178||||||P-value comes from an analysis of covariance with outcome variable of change in average insulin use per kg from baseline and covariates of treatment, baseline average insulin use per kg, and age.|ANCOVA|||Week 24||||0.178
72427373|NCT02293837|144366998|SUPERIORITY|||||||0.43||||||P-value comes from an analysis of covariance with outcome variable of change in average insulin use per kg from baseline and covariates of treatment, baseline average insulin use per kg, and age.|ANCOVA|||Week 52||||0.430
72427374|NCT02293837|144366998|SUPERIORITY|||||||0.149||||||P-value comes from an analysis of covariance with outcome variable of change in average insulin use per kg from baseline and covariates of treatment, baseline average insulin use per kg, and age.|ANCOVA|||Week 104||||0.149
72427375|NCT02293837|144366999|SUPERIORITY|||||||0.103||||||P-value is for group difference in time trends from a longitudinal mixed effects model. Response variable was average insulin use per kg and covariates were treatment, study week, age, treatment\*study week, age\*study week.|Longitudinal mixed model|Random within-subject effects for intercept and study week were included assuming an unstructured covariance matrix.||Screening to Week 104||||0.103
72427376|NCT02293837|144366999|SUPERIORITY|||||||0.452||||||P-value is for group difference in time trends from a longitudinal mixed effects model. Response variable was average insulin use per kg and covariates were treatment, study week, age, treatment\*study week, age\*study week.|Longitudinal mixed model|Random within-subject effects for intercept and study week were included assuming an unstructured covariance matrix.||Screening to Week 104||||0.452
72427377|NCT02293837|144366999|SUPERIORITY|||||||0.091||||||P-value is for group difference in time trends from a longitudinal mixed effects model. Response variable was average insulin use per kg and covariates were treatment, study week, age, treatment\*study week, age\*study week.|Longitudinal mixed model|Random within-subject effects for intercept and study week were included assuming an unstructured covariance matrix.||Screening to Week 104||||0.091
72427378|NCT02293837|144367000|SUPERIORITY|||||||0.154||||||P-value comes from an analysis of covariance with outcome variable of change in HbA1c from baseline and covariates of treatment, baseline HbA1c, and age.|ANCOVA|||Week 24||||0.154
72427379|NCT02293837|144367000|SUPERIORITY|||||||0.193||||||P-value comes from an analysis of covariance with outcome variable of change in HbA1c from baseline and covariates of treatment, baseline HbA1c, and age.|ANCOVA|||Week 52||||0.193
72427380|NCT02293837|144367000|SUPERIORITY|||||||0.397||||||P-value comes from an analysis of covariance with outcome variable of change in HbA1c from baseline and covariates of treatment, baseline HbA1c, and age.|ANCOVA|||Week 104||||0.397
72427381|NCT02293837|144367000|SUPERIORITY|||||||0.125||||||P-value comes from an analysis of covariance with outcome variable of change in HbA1c from baseline and covariates of treatment, baseline HbA1c, and age.|ANCOVA|||Week 24||||0.125
72427382|NCT02293837|144367000|SUPERIORITY|||||||0.705||||||P-value comes from an analysis of covariance with outcome variable of change in HbA1c from baseline and covariates of treatment, baseline HbA1c, and age.|ANCOVA|||Week 52||||0.705
72427383|NCT02293837|144367000|SUPERIORITY|||||||0.378||||||P-value comes from an analysis of covariance with outcome variable of change in HbA1c from baseline and covariates of treatment, baseline HbA1c, and age.|ANCOVA|||Week 104||||0.378
72427384|NCT02293837|144367000|SUPERIORITY|||||||0.035||||||P-value comes from an analysis of covariance with outcome variable of change in HbA1c from baseline and covariates of treatment, baseline HbA1c, and age.|ANCOVA|||Week 24||||0.035
72427385|NCT02293837|144367000|SUPERIORITY|||||||0.262||||||P-value comes from an analysis of covariance with outcome variable of change in HbA1c from baseline and covariates of treatment, baseline HbA1c, and age.|ANCOVA|||Week 52||||0.262
72427386|NCT02293837|144367000|SUPERIORITY|||||||0.338||||||P-value comes from an analysis of covariance with outcome variable of change in HbA1c from baseline and covariates of treatment, baseline HbA1c, and age.|ANCOVA|||Week 104||||0.338
72427387|NCT02293837|144367001|SUPERIORITY|||||||0.493||||||P-value is for group difference in time trends from a longitudinal mixed effects model. Response variable was HbA1c and covariates were treatment, study week, spline week (at week 4), age, treatment\*spline week, treatment\*study week, age\*study week.|Longitudinal mixed model|Random within-subject effects for intercept, study week, and spline week were included assuming an unstructured covariance matrix.||Screening to Week 104||||0.493
72427388|NCT02293837|144367001|SUPERIORITY|||||||0.659||||||P-value is for group difference in time trends from a longitudinal mixed effects model. Response variable was HbA1c and covariates were treatment, study week, spline week (at week 4), age, treatment\*spline week, treatment\*study week, age\*study week.|Longitudinal mixed model|Random within-subject effects for intercept, study week, and spline week were included assuming an unstructured covariance matrix.||Screening to Week 104||||0.659
72427389|NCT02293837|144367001|SUPERIORITY|||||||0.407||||||P-value is for group difference in time trends from a longitudinal mixed effects model. Response variable was HbA1c and covariates were treatment, study week, spline week (at week 4), age, treatment\*spline week, treatment\*study week, age\*study week.|Longitudinal mixed model|Random within-subject effects for intercept, study week, and spline week were included assuming an unstructured covariance matrix.||Screening to Week 104||||0.407
72427390|NCT02293837|144367002|SUPERIORITY|||||||0.634||||||P-value is from comparing the number of participants with a hypoglycemic event between the two treatment groups using Fisher's exact test.|Fisher Exact|||Baseline to Week 52||||0.634
72336336|NCT02868034|144196222|SUPERIORITY||Mean Difference (Final Values)|-0.17||||0.025|TWO_SIDED|97.5|-0.43|0.09|||Mixed Models Analysis|Consistent with the randomized design, mean values for the Phase II baseline were constrained to be equal to a common overall mean.|A negative value indicates greater reduction in stiffness when the component was used|SMT Component Main Effects after 12 weeks||0.09|-0.43|0.025
72336337|NCT02868034|144196222|SUPERIORITY||Mean Difference (Final Values)|0.14||||0.025|TWO_SIDED|97.5|-0.11|0.38|||Mixed Models Analysis|Consistent with the randomized design, mean values for the Phase II baseline were constrained to be equal to a common overall mean.|A negative value indicates greater reduction in stiffness when the component was used|Mobilizing Exercise Treatment Component Main Effects at 4 weeks||0.38|-0.11|0.025
72336338|NCT02868034|144196222|SUPERIORITY||Mean Difference (Final Values)|0.03||||0.025|TWO_SIDED|97.5|-0.23|0.29|||Mixed Models Analysis|Consistent with the randomized design, mean values for the Phase II baseline were constrained to be equal to a common overall mean.|A negative value indicates greater reduction in stiffness when the component was used|Mobilizing Exercise Component Main Effects at 12 weeks||0.29|-0.23|0.025
72336339|NCT02868034|144196222|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.025|TWO_SIDED|97.5|-0.45|0.04|||Mixed Models Analysis|Consistent with the randomized design, mean values for the Phase II baseline were constrained to be equal to a common overall mean.|A negative value indicates greater reduction in stiffness when the component was used|Activating Exercise Component Main Effect at 4 weeks||0.04|-0.45|0.025
72336340|NCT02868034|144196222|SUPERIORITY||Mean Difference (Final Values)|-0.19||||0.025|TWO_SIDED|97.5|-0.45|0.07|||Mixed Models Analysis|Consistent with the randomized design, mean values for the Phase II baseline were constrained to be equal to a common overall mean.|A negative value indicates greater change when the component was used|Activating Exercise Component Main Effect at 12 weeks||0.07|-0.45|0.025
72336341|NCT02868034|144196222|SUPERIORITY||interaction relative mean difference|-0.17||||0.025|TWO_SIDED|97.5|-0.66|0.32|||Mixed Models Analysis|||Pairwise interaction effect of mobilizing and activating exercise components after 4 weeks||0.32|-0.66|0.025
72336342|NCT02868034|144196222|SUPERIORITY||interaction relative mean difference|-0.1||||0.025|TWO_SIDED|97.5|-0.62|0.42|||Mixed Models Analysis|||Pairwise interaction effect of mobilizing and activating exercise components after 12 weeks||0.42|-0.62|0.025
72336343|NCT02868034|144196222|SUPERIORITY||interaction relative mean difference|0.13||||0.025|TWO_SIDED|97.5|-0.36|0.62|||Mixed Models Analysis|||Pairwise interaction effect of SMT and activating exercise components after 4 weeks||0.62|-0.36|0.025
72336344|NCT02868034|144196222|SUPERIORITY||interaction relative mean difference|0.5||||0.025|TWO_SIDED|97.5|-0.02|1.02|||Mixed Models Analysis|||||1.02|-0.02|0.025
72336345|NCT02868034|144196222|SUPERIORITY||interaction relative mean difference|-0.17||||0.025|TWO_SIDED|97.5|-0.66|0.32|||Mixed Models Analysis|||Pairwise interaction effect of SMT and mobilizing exercise components after 4 weeks||0.32|-0.66|0.025
72336346|NCT02868034|144196222|SUPERIORITY||interaction relative mean difference|0.39||||0.025|TWO_SIDED|97.5|-0.13|0.91|||Mixed Models Analysis|||Pairwise interaction effect of SMT and mobilizing exercise components after 12 weeks||0.91|-0.13|0.025
72427391|NCT02293837|144367002|SUPERIORITY|||||||1||||||P-value is from comparing the number of participants with a hypoglycemic event between the two treatment groups using Fisher's exact test.|Fisher Exact|||Baseline to Week 104/End of Study||||1.000
72427392|NCT02293837|144367002|SUPERIORITY|||||||0.329||||||P-value is from comparing the number of participants with a hypoglycemic event between the two treatment groups using Fisher's exact test.|Fisher Exact|||Baseline to Week 52||||0.329
72427393|NCT02293837|144367002|SUPERIORITY|||||||1||||||P-value is from comparing the number of participants with a hypoglycemic event between the two treatment groups using Fisher's exact test.|Fisher Exact|||Baseline to Week 104/End of Study||||1.000
72427394|NCT02293837|144367002|SUPERIORITY|||||||0.847||||||P-value is from comparing the number of participants with a hypoglycemic event between the two treatment groups using Fisher's exact test.|Fisher Exact|||Baseline to Week 52||||0.847
72427395|NCT02293837|144367002|SUPERIORITY|||||||0.858||||||P-value is from comparing the number of participants with a hypoglycemic event between the two treatment groups using Fisher's exact test.|Fisher Exact|||Baseline to Week 104/End of Study||||0.858
72427396|NCT02293837|144367003|SUPERIORITY|||||||0.296||||||P-value is from comparing the number of participants with the AEs of interest between the two treatment groups using Fisher's exact test.|Fisher Exact|||Treatment start to Week 52||||0.296
72427397|NCT02293837|144367003|SUPERIORITY|||||||0.145||||||P-value is from comparing the number of participants with the AEs of interest between the two treatment groups using Fisher's exact test.|Fisher Exact|||Treatment start to Week 52||||0.145
72427398|NCT02293837|144367003|SUPERIORITY|||||||0.027||||||P-value is from comparing the number of participants with the AEs of interest between the two treatment groups using Fisher's exact test.|Fisher Exact|||Treatment start to Week 52||||0.027
72427399|NCT02293837|144367004|SUPERIORITY|||||||0.547||||||P-value is from comparing the number of participants with the AEs of interest between the two treatment groups using Fisher's exact test.|Fisher Exact|||Treatment start to Week 52||||0.547
72427400|NCT02293837|144367004|SUPERIORITY|||||||0.551||||||P-value is from comparing the number of participants with the AEs of interest between the two treatment groups using Fisher's exact test.|Fisher Exact|||Treatment start to Week 52||||0.551
72427401|NCT04779242|144367005|OTHER|Difference was observed difference in early clinical success rate between the omadacycline and moxifloxacin groups|Percentage difference|1.9|||||TWO_SIDED|95.0|-3.0|6.8|||||95% CI is constructed based on the Miettinen and Nurminen method without stratification.|||6.8|-3.0|
72427402|NCT04779242|144367006|OTHER|Difference was observed difference in overall clinical success rate at PTE between the omadacycline and moxifloxacin groups.|Percentage difference|-1.7|||||TWO_SIDED|95.0|-6.9|3.4|||||95% CI is constructed based on the Miettinen and Nurminen method without stratification|||3.4|-6.9|
72427403|NCT04779242|144367007|OTHER|Difference was observed difference in overall clinical success rate at PTE between the omadacycline and moxifloxacin groups|Percentage difference|-1.8|||||TWO_SIDED|95.0|-5.7|2.0|||||95% CI is constructed based on the Miettinen and Nurminen method without stratification|||2.0|-5.7|
72427404|NCT01757067|144367008|OTHER|The previously stated primary and secondary endpoints cannot be calculated as the study was halted prematurely due to lack of enrollment. Only the reported EF data was collected. This makes further statistical analyses impossible.|||||||||||||||||The previously stated primary and secondary endpoints cannot be calculated as the study was halted prematurely due to lack of enrollment. Only the reported EF data was collected. This makes further statistical analyses impossible.|||
72427405|NCT02942004|144367024|SUPERIORITY||Least Square (LS) Mean Difference|-5.5|STANDARD_ERROR_OF_MEAN|1.664||0.0013|TWO_SIDED|95.0|-8.8|-2.2|||MMRM|||Mixed effect model for repeated measures (MMRM) was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-2.20|-8.80|0.0013
72336347|NCT02868034|144196222|SUPERIORITY||3-way interaction relative mean dif.|0.25||||0.025|TWO_SIDED|97.5|-0.24|0.74|||Mixed Models Analysis|||Three-way interaction effect of SMT, activating exercise and mobilizing exercise components after 4 weeks||0.74|-0.24|0.025
72427406|NCT02942004|144367024|SUPERIORITY||LS mean difference|-3.68|STANDARD_ERROR_OF_MEAN|1.622||0.0252|TWO_SIDED|95.0|-6.9|-0.47|||MMRM|||MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.47|-6.90|0.0252
72427407|NCT02942004|144367025|SUPERIORITY||LS mean difference|-5.63|STANDARD_ERROR_OF_MEAN|1.936||0.0044|TWO_SIDED|95.0|-9.46|-1.79|||MMRM|||MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-1.79|-9.46|0.0044
72336348|NCT02868034|144196222|SUPERIORITY||3-way interaction relative mean dif.|0.4||||0.025|TWO_SIDED|97.5|-0.12|0.92|||Mixed Models Analysis|||Three-way interaction effect of SMT, activating exercise and mobilizing exercise components after 12 weeks||0.92|-0.12|0.025
72427408|NCT02942004|144367025|SUPERIORITY||LS mean difference|-3.79|STANDARD_ERROR_OF_MEAN|1.899||0.0481|TWO_SIDED|95.0|-7.56|-0.03|||MMRM|||MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.03|-7.56|0.0481
72336349|NCT02868034|144196223|SUPERIORITY||Mean Difference (Final Values)|-0.57||||0.025|TWO_SIDED|97.5|-2.67|1.52|||Mixed Models Analysis|Consistent with the randomized design, mean values for the Phase II baseline were constrained to be equal to a common overall mean.||SMT Component Main Effects at 4 weeks|A positive value indicates greater improvement in muscle activation when the component was used|1.52|-2.67|0.025
72336350|NCT02868034|144196223|SUPERIORITY||Mean Difference (Final Values)|-0.37||||0.025|TWO_SIDED|97.5|-2.76|2.02|||Mixed Models Analysis|Consistent with the randomized design, mean values for the Phase II baseline were constrained to be equal to a common overall mean.|A positive value indicates greater improvement in muscle activation when the component was used|SMT Component Main Effects at 12 weeks||2.02|-2.76|0.025
72336351|NCT02868034|144196223|SUPERIORITY||Mean Difference (Final Values)|0.06||||0.025|TWO_SIDED|97.5|-2.03|2.16|||Mixed Models Analysis|Consistent with the randomized design, mean values for the Phase II baseline were constrained to be equal to a common overall mean.|A positive value indicates greater improvement in muscle activation when the component was used|Mobilizing Component Main Effects at 4 weeks||2.16|-2.03|0.025
72336352|NCT02868034|144196223|SUPERIORITY||Mean Difference (Final Values)|0.71||||0.025|TWO_SIDED|97.5|-1.68|3.11|||Mixed Models Analysis|Consistent with the randomized design, mean values for the Phase II baseline were constrained to be equal to a common overall mean.|A positive value indicates greater improvement in muscle activation when the component was used|Mobilizing Component Main Effects at 12 weeks||3.11|-1.68|0.025
72336353|NCT02868034|144196223|SUPERIORITY||Mean Difference (Final Values)|-0.85||||0.025|TWO_SIDED|97.5|-2.94|1.25|||Mixed Models Analysis|Consistent with the randomized design, mean values for the Phase II baseline were constrained to be equal to a common overall mean.|A positive value indicates greater improvement in muscle activation when the component was used|Activating Exercise Component at 4 weeks||1.25|-2.94|0.025
72336354|NCT02868034|144196223|SUPERIORITY||Mean Difference (Final Values)|-0.57||||0.025|TWO_SIDED|97.5|-2.97|1.82|||Mixed Models Analysis|Consistent with the randomized design, mean values for the Phase II baseline were constrained to be equal to a common overall mean.|A positive value indicates greater improvement in muscle activation when the component was used|Activating Exercise Component at 12 weeks||1.82|-2.97|0.025
72336355|NCT02868034|144196223|SUPERIORITY||interaction relative mean difference|0.8||||0.025|TWO_SIDED|97.5|-3.39|4.99|||Mixed Models Analysis|||Pairwise interaction effect of mobilizing and activating exercise components after 4 weeks||4.99|-3.39|0.025
72427409|NCT02942004|144367026|SUPERIORITY||LS mean difference|0.05|STANDARD_ERROR_OF_MEAN|0.951||0.9591|TWO_SIDED|95.0|-1.83|1.93|||MMRM|||Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||1.93|-1.83|0.9591
72427410|NCT02942004|144367026|SUPERIORITY||LS mean difference|0.15|STANDARD_ERROR_OF_MEAN|0.917||0.8677|TWO_SIDED|95.0|-1.66|1.97|||MMRM|||Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||1.97|-1.66|0.8677
72427411|NCT02942004|144367026|SUPERIORITY||LS mean difference|-2.11|STANDARD_ERROR_OF_MEAN|1.208||0.0827|TWO_SIDED|95.0|-4.51|0.28|||MMRM|||Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.28|-4.51|0.0827
72427412|NCT02942004|144367026|SUPERIORITY||LS mean difference|-0.3|STANDARD_ERROR_OF_MEAN|1.172||0.7968|TWO_SIDED|95.0|-2.62|2.02|||MMRM|||Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||2.02|-2.62|0.7968
72427413|NCT02942004|144367026|SUPERIORITY||LS mean difference|-2.04|STANDARD_ERROR_OF_MEAN|1.336||0.1292|TWO_SIDED|95.0|-4.69|0.61|||MMRM|||Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.61|-4.69|0.1292
72427414|NCT02942004|144367026|SUPERIORITY||LS mean difference|-0.36|STANDARD_ERROR_OF_MEAN|1.299||0.7801|TWO_SIDED|95.0|-2.94|2.21|||MMRM|||Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||2.21|-2.94|0.7801
72427415|NCT02942004|144367026|SUPERIORITY||LS mean difference|-1.25|STANDARD_ERROR_OF_MEAN|1.436||0.384|TWO_SIDED|95.0|-4.1|1.59|||MMRM|||Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||1.59|-4.10|0.3840
72427416|NCT02942004|144367026|SUPERIORITY||LS mean difference|0.71|STANDARD_ERROR_OF_MEAN|1.395||0.6097|TWO_SIDED|0.71|-2.05|3.48|||MMRM|||Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||3.48|-2.05|0.6097
72427417|NCT02942004|144367026|SUPERIORITY||LS mean difference|-4.28|STANDARD_ERROR_OF_MEAN|1.622||0.0094|TWO_SIDED|95.0|-7.5|-1.07|||MMRM|||Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-1.07|-7.50|0.0094
72427418|NCT02942004|144367026|SUPERIORITY||LS mean difference|-2.32|STANDARD_ERROR_OF_MEAN|1.577||0.144|TWO_SIDED|95.0|-5.45|0.8|||MMRM|||Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.80|-5.45|0.1440
72427419|NCT02942004|144367026|SUPERIORITY||LS mean difference|-5.12|STANDARD_ERROR_OF_MEAN|1.62||0.002|TWO_SIDED|95.0|-8.33|-1.91|||MMRM|||Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-1.91|-8.33|0.0020
72427420|NCT02942004|144367026|SUPERIORITY||LS mean difference|-1.36|STANDARD_ERROR_OF_MEAN|1.572||0.3906|TWO_SIDED|95.0|-4.47|1.76|||MMRM|||Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||1.76|-4.47|0.3906
72427421|NCT02942004|144367026|SUPERIORITY||LS mean difference|-4.49|STANDARD_ERROR_OF_MEAN|1.735||0.011|TWO_SIDED|95.0|-7.93|-1.05|||MMRM|||Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-1.05|-7.93|0.0110
72336356|NCT02868034|144196223|SUPERIORITY||interaction relative mean difference|-0.68||||0.025|TWO_SIDED|97.5|-5.47|4.11|||Mixed Models Analysis|||Pairwise interaction effect of mobilizing and activating exercise components after 12 weeks||4.11|-5.47|0.025
72336357|NCT02868034|144196223|SUPERIORITY||interaction relative mean difference|-1.56||||0.025|TWO_SIDED|97.5|-5.75|2.63|||Mixed Models Analysis|||Pairwise interaction effect of SMT and activating exercise components after 4 weeks||2.63|-5.75|0.025
72336358|NCT02868034|144196223|SUPERIORITY||interaction relative mean difference|1.42||||0.025|TWO_SIDED|97.5|-3.37|6.21|||Mixed Models Analysis|||Pairwise interaction effect of SMT and activating exercise components after 12 weeks||6.21|-3.37|0.025
72336359|NCT02868034|144196223|SUPERIORITY||interaction relative mean difference|-0.44||||0.025|TWO_SIDED|97.5|-4.63|3.75|||Mixed Models Analysis|||Pairwise interaction effect of SMT and mobilizing exercise components after 4 weeks||3.75|-4.63|0.025
72336360|NCT02868034|144196223|SUPERIORITY||interaction relative mean difference|2.01||||0.025|TWO_SIDED|97.5|-2.77|6.8|||Mixed Models Analysis|||Pairwise interaction effect of SMT and mobilizing exercise components after 12 weeks||6.80|-2.77|0.025
72336361|NCT02868034|144196223|SUPERIORITY||3-way interaction relative mean dif.|-0.18||||0.025|TWO_SIDED|97.5|-4.37|4.01|||Mixed Models Analysis|||Three-way interaction effect of SMT, activating exercise and mobilizing exercise components after 4 weeks||4.01|-4.37|0.025
72336362|NCT02868034|144196223|SUPERIORITY||3-way interaction relative mean dif.|0.56||||0.025|TWO_SIDED|97.5|-4.22|5.35|||Mixed Models Analysis|||Three-way interaction effect of SMT, activating exercise and mobilizing exercise components after 12 weeks||5.35|-4.22|0.025
72336363|NCT02868034|144196224|SUPERIORITY||Mean Difference (Final Values)|-1.16||||0.025|TWO_SIDED|97.5|-4.0|1.68|||Mixed Models Analysis|Consistent with the randomized design, mean values for the Phase II baseline were constrained to be equal to a common overall mean.|A negative value indicates greater improvement in disability when the component was used|SMT Treatment Component Main Effect at 4-weeks||1.68|-4.0|0.025
72427422|NCT02942004|144367026|SUPERIORITY||LS mean difference|-3.33|STANDARD_ERROR_OF_MEAN|1.69||0.0511|TWO_SIDED|95.0|-6.68|0.02|||MMRM|||Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.02|-6.68|0.0511
72336364|NCT02868034|144196224|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.025|TWO_SIDED|97.5|-3.46|3.07|||Mixed Models Analysis|Consistent with the randomized design, mean values for the Phase II baseline were constrained to be equal to a common overall mean.|A negative value indicates greater improvement in disability when the component was used|SMT Treatment Component Main Effect at 12-weeks||3.07|-3.46|0.025
72336365|NCT02868034|144196224|SUPERIORITY||Mean Difference (Final Values)|-1.36||||0.025|TWO_SIDED|97.5|-4.2|1.48|||Mixed Models Analysis|Consistent with the randomized design, mean values for the Phase II baseline were constrained to be equal to a common overall mean.|A negative value indicates greater improvement in disability when the component was used|Mobilizing Exercise Treatment Component main effect after 4-weeks||1.48|-4.2|0.025
72427423|NCT02942004|144367026|SUPERIORITY||LS mean difference|-5.02|STANDARD_ERROR_OF_MEAN|1.738||0.0046|TWO_SIDED|95.0|-8.47|-1.58|||MMRM|||Change at hour 72: MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-1.58|-8.47|0.0046
72336366|NCT02868034|144196224|SUPERIORITY||Mean Difference (Final Values)|-1.72||||0.025|TWO_SIDED|97.5|-4.99|1.55|||Mixed Models Analysis|Consistent with the randomized design, mean values for the Phase II baseline were constrained to be equal to a common overall mean.|A negative value indicates greater improvement in disability when the component was used|Mobilizing Exercise Treatment Component main effect after 12-weeks||1.55|-4.99|0.025
72336367|NCT02868034|144196224|SUPERIORITY||Mean Difference (Final Values)|-2.34||||0.025|TWO_SIDED|97.5|-5.18|0.5|||Mixed Models Analysis|Consistent with the randomized design, mean values for the Phase II baseline were constrained to be equal to a common overall mean.|A negative value indicates greater improvement in disability when the component was used|Activating Exercise Treatment Component main effect after 4-weeks||0.50|-5.18|0.025
72336368|NCT02868034|144196224|SUPERIORITY||Mean Difference (Final Values)|-3.62||||0.025|TWO_SIDED|97.5|-6.89|-0.35|||Mixed Models Analysis|Consistent with the randomized design, mean values for the Phase II baseline were constrained to be equal to a common overall mean.|A negative value indicates greater improvement in disability when the component was used|Activating Treatment Component Main Effect after 12-weeks||-0.35|-6.89|0.025
72336369|NCT02868034|144196224|SUPERIORITY||interaction relative mean difference|3.24||||0.025|TWO_SIDED|97.5|-2.45|8.92|||Mixed Models Analysis|||Pairwise interaction effect of mobilizing and activating exercise components after 4 weeks||8.92|-2.45|0.025
72336370|NCT02868034|144196224|SUPERIORITY||interaction relative mean difference|4.34||||0.025|TWO_SIDED|97.5|-2.19|10.87|||Mixed Models Analysis|||Pairwise interaction effect of mobilizing and activating exercise components after 12 weeks||10.87|-2.19|0.025
72336371|NCT02868034|144196224|SUPERIORITY||interaction relative mean difference|0.57||||0.025|TWO_SIDED|97.5|-5.12|6.25|||Mixed Models Analysis|||Pairwise interaction effect of SMT and activating exercise components after 4 weeks||6.25|-5.12|0.025
72336372|NCT02868034|144196224|SUPERIORITY||interaction relative mean difference|-0.67||||0.025|TWO_SIDED|97.5|-7.2|5.87|||Mixed Models Analysis|||Pairwise interaction effect of SMT and activating exercise components after 12 weeks||5.87|-7.20|0.025
72336373|NCT02868034|144196224|SUPERIORITY||interaction relative mean difference|4.64||||0.025|TWO_SIDED|97.5|-1.04|10.32|||Mixed Models Analysis|||Pairwise interaction effect of SMT and mobilizing exercise components after 4 weeks||10.32|-1.04|0.025
72336374|NCT02868034|144196224|SUPERIORITY||interaction relative mean difference|1.49||||0.025|TWO_SIDED|97.5|-5.04|8.02|||Mixed Models Analysis|||Pairwise interaction effect of SMT and mobilizing exercise components after 12 weeks||8.02|-5.04|0.025
72336375|NCT02868034|144196224|SUPERIORITY||3-way interaction relative mean dif.|-0.86||||0.025|TWO_SIDED|97.5|-6.54|4.82|||Mixed Models Analysis|||3-way interaction effect of SMT, activating exercise and mobilizing exercise components after 4 weeks||4.82|-6.54|0.025
72336376|NCT02868034|144196224|SUPERIORITY||3-way interaction relative mean dif.|0.04||||0.025|TWO_SIDED|97.5|-6.5|6.57|||Mixed Models Analysis|||3-way interaction effect of SMT, activating exercise and mobilizing exercise components after 12 weeks||6.57|-6.50|0.025
72336377|NCT02868034|144196225|SUPERIORITY||Mean Difference (Final Values)|-0.14||||0.025|TWO_SIDED|97.5|-0.6|0.32|||Mixed Models Analysis|Consistent with the randomized design, mean values for the Phase II baseline were constrained to be equal to a common overall mean.|A negative value indicates greater reduction in pain intensity when the component was used|SMT Treatment Component Main Effect at 4-weeks||0.32|-0.60|0.025
72336378|NCT02868034|144196225|SUPERIORITY||Mean Difference (Final Values)|0.08||||0.025|TWO_SIDED|97.5|-0.44|0.61|||Mixed Models Analysis|Consistent with the randomized design, mean values for the Phase II baseline were constrained to be equal to a common overall mean.|A negative value indicates greater reduction in pain intensity when the component was used|SMT Treatment Component Main Effects at 12 weeks||0.61|-0.44|0.025
72336379|NCT02868034|144196225|SUPERIORITY||Mean Difference (Final Values)|-0.46||||0.025|TWO_SIDED|97.5|-0.92|0.0|||Mixed Models Analysis|Consistent with the randomized design, mean values for the Phase II baseline were constrained to be equal to a common overall mean.|A negative value indicates greater reduction in pain intensity when the component was used|Mobilizing Exercise Component Main Effects at 4 weeks||0.0|-0.92|0.025
72336380|NCT02868034|144196225|SUPERIORITY||Mean Difference (Final Values)|-0.18||||0.025|TWO_SIDED|97.5|-0.7|0.34|||Mixed Models Analysis|Consistent with the randomized design, mean values for the Phase II baseline were constrained to be equal to a common overall mean.|A negative value indicates greater reduction in pain intensity when the component was used|Mobilizing Exercise Component Main Effects at 12 weeks||0.34|-0.70|0.025
72336381|NCT02868034|144196225|SUPERIORITY||Mean Difference (Final Values)|-0.16||||0.025|TWO_SIDED|97.5|-0.62|0.3|||Mixed Models Analysis|Consistent with the randomized design, mean values for the Phase II baseline were constrained to be equal to a common overall mean.|A negative value indicates greater reduction in pain intensity when the component was used|Activating Exercise Component Main Effects at 4 weeks||0.30|-0.62|0.025
72336382|NCT02868034|144196225|SUPERIORITY||Mean Difference (Final Values)|-0.19||||0.025|TWO_SIDED|97.5|-0.71|0.33|||Mixed Models Analysis|Consistent with the randomized design, mean values for the Phase II baseline were constrained to be equal to a common overall mean.|A negative value indicates greater reduction in pain intensity when the component was used|Activating Exercise Component Main Effects at 12 weeks||0.33|-0.71|0.025
72336383|NCT02868034|144196225|SUPERIORITY||interaction relative mean difference|0.38||||0.025|TWO_SIDED|97.5|-0.54|1.3|||Mixed Models Analysis|||Pairwise interaction effect of mobilizing and activating exercise components after 4 weeks||1.30|-0.54|0.025
72336384|NCT02868034|144196225|SUPERIORITY||interaction relative mean difference|0.45||||0.025|TWO_SIDED|97.5|-0.6|1.49|||Mixed Models Analysis|||Pairwise interaction effect of mobilizing and activating exercise components after 12 weeks||1.49|-0.60|0.025
72336385|NCT02868034|144196225|SUPERIORITY||interaction relative mean difference|0.12||||0.025|TWO_SIDED|97.5|-0.8|1.04|||Mixed Models Analysis|||Pairwise interaction effect of SMT and activating exercise components after 4 weeks||1.04|-0.80|0.025
72427424|NCT02942004|144367026|SUPERIORITY||LS mean difference|-2.53|STANDARD_ERROR_OF_MEAN|1.694||0.1389|TWO_SIDED|95.0|-5.88|0.83|||MMRM|||Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.83|-5.88|0.1389
72427425|NCT02942004|144367026|SUPERIORITY||LS mean difference|-4.07|STANDARD_ERROR_OF_MEAN|1.837||0.0288|TWO_SIDED|95.0|-7.71|-0.43|||MMRM|||Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.43|-7.71|0.0288
72427426|NCT02942004|144367026|SUPERIORITY||LS mean difference|-1.58|STANDARD_ERROR_OF_MEAN|1.797||0.3799|TWO_SIDED|95.0|-5.15|1.98|||MMRM|||Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||1.98|-5.15|0.3799
72336386|NCT02868034|144196225|SUPERIORITY||interaction relative mean difference|0.23||||0.025|TWO_SIDED|97.5|-0.81|1.28|||Mixed Models Analysis|||Pairwise interaction effect of SMT and activating exercise components after 12 weeks||1.28|-0.81|0.025
72336387|NCT02868034|144196225|SUPERIORITY||interaction relative mean difference|0.89||||0.025|TWO_SIDED|97.5|-0.03|1.81|||Mixed Models Analysis|||||1.81|-0.03|0.025
72336388|NCT02868034|144196225|SUPERIORITY||interaction relative mean difference|-0.02||||0.025|TWO_SIDED|97.5|-1.07|1.02|||Mixed Models Analysis|||Pairwise interaction effect of SMT and mobilizing exercise components after 12 weeks||1.02|-1.07|0.025
72336389|NCT02868034|144196225|SUPERIORITY||3-way interaction relative mean dif.|0.71||||0.025|TWO_SIDED|97.5|-0.21|1.63|||Mixed Models Analysis|||3-way interaction effect of SMT, activating exercise and mobilizing exercise components after 4 weeks||1.63|-0.21|0.025
72427427|NCT02942004|144367026|SUPERIORITY||LS mean difference|-2.92|STANDARD_ERROR_OF_MEAN|2.139||0.1747|TWO_SIDED|95.0|-7.16|1.32|||MMRM|||Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||1.32|-7.16|0.1747
72427428|NCT02942004|144367026|SUPERIORITY||LS mean difference|-1.0|STANDARD_ERROR_OF_MEAN|2.08||0.631|TWO_SIDED|95.0|-5.13|3.12|||MMRM|||Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||3.12|-5.13|0.6310
72427429|NCT02942004|144367026|SUPERIORITY||LS mean difference|-4.92|STANDARD_ERROR_OF_MEAN|2.045||0.0178|TWO_SIDED|95.0|-8.98|-0.87|||MMRM|||Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.87|-8.98|0.0178
72427430|NCT02942004|144367026|SUPERIORITY||LS mean difference|-3.51|STANDARD_ERROR_OF_MEAN|1.976||0.0786|TWO_SIDED|95.0|-7.43|0.41|||MMRM|||Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.41|-7.43|0.0786
72427431|NCT02942004|144367027|SUPERIORITY||Odds Ratio (OR)|5.4||||0.0052|TWO_SIDED|95.0|1.7|17.4|||GEE method|||Hour 60: Generalized estimating equation (GEE) method was used for analysis. The HAM-D response at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. An exchangeable working correlation structure is assumed for the model parameters estimation.||17.4|1.7|0.0052
72427432|NCT02942004|144367027|SUPERIORITY||Odds Ratio (OR)|2.6||||0.0493|TWO_SIDED|95.0|1.0|6.9|||GEE method|||Hour 60: GEE method was used for analysis. The HAM-D response at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. An exchangeable working correlation structure is assumed for the model parameters estimation.||6.9|1.0|0.0493
72427433|NCT02942004|144367027|SUPERIORITY||Odds Ratio (OR)|2.5||||0.0572|TWO_SIDED|95.0|1.0|6.5|||GEE method|||Day 7: GEE method was used for analysis. The HAM-D response at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. An exchangeable working correlation structure is assumed for the model parameters estimation.||6.5|1.0|0.0572
72427434|NCT02942004|144367027|SUPERIORITY||Odds Ratio (OR)|1.2||||0.6768|TWO_SIDED|95.0|0.5|3.0|||GEE method|||Day 7: GEE method was used for analysis. The HAM-D response at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. An exchangeable working correlation structure is assumed for the model parameters estimation.||3.0|0.5|0.6768
72427435|NCT02942004|144367027|SUPERIORITY||Odds Ratio (OR)|5.4||||0.0035|TWO_SIDED|95.0|1.7|16.8|||GEE method|||Day 30: GEE method was used for analysis. The HAM-D response at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. An exchangeable working correlation structure is assumed for the model parameters estimation.||16.8|1.7|0.0035
72427436|NCT02942004|144367027|SUPERIORITY||Odds Ratio (OR)|2.9||||0.0347|TWO_SIDED|95.0|1.1|7.8|||GEE method|||Day 30: GEE method was used for analysis. The HAM-D response at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. An exchangeable working correlation structure is assumed for the model parameters estimation.||7.8|1.1|0.0347
72427437|NCT02942004|144367028|SUPERIORITY||Odds Ratio (OR)|6.0||||0.0011|TWO_SIDED|95.0|2.1|17.8|||GEE method|||Hour 60: GEE method was used for analysis. The HAM-D response at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. An exchangeable working correlation structure is assumed for the model parameters estimation.||17.8|2.1|0.0011
72427438|NCT02942004|144367028|SUPERIORITY||Odds Ratio (OR)|2.6||||0.0828|TWO_SIDED|95.0|0.9|7.6|||GEE method|||Hour 60: GEE method was used for analysis. The HAM-D response at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. An exchangeable working correlation structure is assumed for the model parameters estimation.||7.6|0.9|0.0828
72427439|NCT02942004|144367028|SUPERIORITY||Odds Ratio (OR)|1.2||||0.7749|TWO_SIDED|95.0|0.4|3.1|||GEE method|||Day 7: GEE method was used for analysis. The HAM-D response at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. An exchangeable working correlation structure is assumed for the model parameters estimation.||3.1|0.4|0.7749
72427440|NCT02942004|144367028|SUPERIORITY||Odds Ratio (OR)|0.6||||0.3401|TWO_SIDED|95.0|0.2|1.7|||GEE method|||Day 7: GEE method was used for analysis. The HAM-D response at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. An exchangeable working correlation structure is assumed for the model parameters estimation.||1.7|0.2|0.3401
72427441|NCT02942004|144367028|SUPERIORITY||Odds Ratio (OR)|2.3||||0.1052|TWO_SIDED|95.0|0.8|6.0|||GEE method|||Day 30: GEE method was used for analysis. The HAM-D response at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. An exchangeable working correlation structure is assumed for the model parameters estimation.||6.0|0.8|0.1052
72427442|NCT02942004|144367028|SUPERIORITY||Odds Ratio (OR)|1.6||||0.3507|TWO_SIDED|95.0|0.6|4.2|||GEE method|||Day 30: GEE method was used for analysis. The HAM-D response at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. An exchangeable working correlation structure is assumed for the model parameters estimation.||4.2|0.6|0.3507
72427443|NCT02942004|144367029|SUPERIORITY||LS mean difference|-12.07|STANDARD_ERROR_OF_MEAN|4.294||0.0058|TWO_SIDED|95.0|-20.58|-3.56|||MMRM|||Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D subscales at each visit as the dependent variable. Treatment, baseline HAM-D subscales, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables are included in the model. All explanatory variables including pooled center are treated as fixed effects.||-3.56|-20.58|0.0058
72427444|NCT02942004|144367029|SUPERIORITY||LS mean difference|-5.89|STANDARD_ERROR_OF_MEAN|4.188||0.1622|TWO_SIDED|95.0|-14.19|2.41|||MMRM|||Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D subscales at each visit as the dependent variable. Treatment, baseline HAM-D subscales, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables are included in the model. All explanatory variables including pooled center are treated as fixed effects.||2.41|-14.19|0.1622
72427445|NCT02942004|144367029|SUPERIORITY||LS mean difference|-9.09|STANDARD_ERROR_OF_MEAN|4.51||0.0462|TWO_SIDED|95.0|-18.02|-0.16|||MMRM|||Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D subscales at each visit as the dependent variable. Treatment, baseline HAM-D subscales, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables are included in the model. All explanatory variables including pooled center are treated as fixed effects.||-0.16|-18.02|0.0462
72336390|NCT02868034|144196225|SUPERIORITY||3-way interaction relative mean dif.|0.0||||0.025|TWO_SIDED|97.5|-1.05|1.04|||Mixed Models Analysis|||3-way interaction effect of SMT, activating exercise and mobilizing exercise components after 12 weeks||1.04|-1.05|0.025
72336391|NCT01509677|144196228|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7922||||||"This is p-value testing significance of treatment effect"|Poisson regression model|||2-sided test at 5% significant level||||0.7922
72336392|NCT01509677|144196228|SUPERIORITY||Risk Ratio (RR)|1.03|STANDARD_ERROR_OF_MEAN|0.12||0.7917|TWO_SIDED|95.0|0.82|1.3|||Poisson regression model|||||1.30|0.82|0.7917
72336393|NCT01509677|144196229|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7145||||||"This is p-value testing significance of treatment effect"|Poisson regression model|||2-sided, 5% test||||0.7145
72336394|NCT01509677|144196230|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|1.04|STANDARD_ERROR_OF_MEAN|0.119||0.7136|TWO_SIDED|95.0|0.83|1.3|||Poisson regression model|||2-sided 5% test||1.30|0.83|0.7136
72336395|NCT01509677|144196231|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|11.4|STANDARD_ERROR_OF_MEAN|15.45||0.4606||95.0|-19.2|42.1|||ANCOVA|||2-sided 5% test||42.1|-19.2|0.4606
72336396|NCT01509677|144196232|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|1.19|STANDARD_ERROR_OF_MEAN|0.194||0.2744|TWO_SIDED|95.0|0.87|1.64|||Poisson regression model|||2-sided 5% test||1.64|0.87|0.2744
72336397|NCT01509677|144196233|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.85|STANDARD_ERROR_OF_MEAN|0.086||0.1128|TWO_SIDED|95.0|0.7|1.04|||Poisson regression model|||2-sided 5% test||1.04|0.70|0.1128
72427446|NCT02942004|144367029|SUPERIORITY||LS mean difference|-2.24|STANDARD_ERROR_OF_MEAN|4.41||0.6124|TWO_SIDED|95.0|-10.97|6.49|||MMRM|||Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D subscales at each visit as the dependent variable. Treatment, baseline HAM-D subscales, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables are included in the model. All explanatory variables including pooled center are treated as fixed effects.||6.49|-10.97|0.6124
72427447|NCT02942004|144367029|SUPERIORITY||LS mean difference|-11.68|STANDARD_ERROR_OF_MEAN|4.556||0.0116|TWO_SIDED|95.0|-20.71|-2.66|||MMRM|||Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D subscales at each visit as the dependent variable. Treatment, baseline HAM-D subscales, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables are included in the model. All explanatory variables including pooled center are treated as fixed effects.||-2.66|-20.71|0.0116
72427448|NCT02942004|144367029|SUPERIORITY||LS mean difference|-8.26|STANDARD_ERROR_OF_MEAN|4.464||0.0667|TWO_SIDED|95.0|-17.1|0.58|||MMRM|||Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D subscales at each visit as the dependent variable. Treatment, baseline HAM-D subscales, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables are included in the model. All explanatory variables including pooled center are treated as fixed effects.||0.58|-17.10|0.0667
72427449|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.01|STANDARD_ERROR_OF_MEAN|0.191||0.9681|TWO_SIDED|95.0|-0.39|0.37|||MMRM|||Depressed Mood, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.37|-0.39|0.9681
72427450|NCT02942004|144367030|SUPERIORITY||LS mean difference|0.09|STANDARD_ERROR_OF_MEAN|0.185||0.6337|TWO_SIDED|95.0|-0.28|0.46|||MMRM|||Depressed Mood, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.46|-0.28|0.6337
72427451|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.17|STANDARD_ERROR_OF_MEAN|0.238||0.469|TWO_SIDED|95.0|-0.64|0.3|||MMRM|||Depressed Mood, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.30|-0.64|0.4690
72427452|NCT02942004|144367030|SUPERIORITY||LS mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.232||0.9905|TWO_SIDED|95.0|-0.46|0.46|||MMRM|||Depressed Mood, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.46|-0.46|0.9905
72427453|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.24||0.3984|TWO_SIDED|95.0|-0.68|0.27|||MMRM|||Depressed Mood, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.27|-0.68|0.3984
72427454|NCT02942004|144367030|SUPERIORITY||LS mean difference|0.09|STANDARD_ERROR_OF_MEAN|0.234||0.7042|TWO_SIDED|95.0|-0.37|0.55|||MMRM|||Depressed Mood, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.55|-0.37|0.7042
72427455|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.17|STANDARD_ERROR_OF_MEAN|0.247||0.4941|TWO_SIDED|95.0|-0.66|0.32|||MMRM|||Depressed Mood, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.32|-0.66|0.4941
72336398|NCT01509677|144196234|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.93|STANDARD_ERROR_OF_MEAN|0.164||0.674|TWO_SIDED|95.0|0.66|1.31|||Regression, Linear|Poisson regression model||2-sided 5% test||1.31|0.66|0.6740
72336399|NCT01509677|144196235|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.84|STANDARD_ERROR_OF_MEAN|0.082||0.0677|TWO_SIDED|95.0|0.69|1.01|||Poisson regression model|||2-sided 5% test||1.01|0.69|0.0677
72336400|NCT01509677|144196236|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.82|STANDARD_ERROR_OF_MEAN|0.177||0.3566|TWO_SIDED|95.0|0.54|1.25|||Poisson regression model|||2-sided 5% test||1.25|0.54|0.3566
72336401|NCT01509677|144196237|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.6354|STANDARD_ERROR_OF_MEAN|2.30185||0.4794|TWO_SIDED|95.0|-2.9429|6.2137|||ANCOVA|||2 sided 5% test||6.2137|-2.9429|0.4794
72336402|NCT01509677|144196238|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.4727|STANDARD_ERROR_OF_MEAN|0.32866||0.1541|TWO_SIDED|95.0|-0.181|1.1264|||ANCOVA|||2 sided 5% test||1.1264|-0.1810|0.1541
72336403|NCT01509677|144196239|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.0626|STANDARD_ERROR_OF_MEAN|0.03681||0.0927|TWO_SIDED|95.0|-0.1358|0.0106|||ANCOVA|||2 sided 5% test||0.0106|-0.1358|0.0927
72336404|NCT01509677|144196240|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.0107|STANDARD_ERROR_OF_MEAN|0.01647||0.5175|TWO_SIDED|95.0|-0.0435|0.022|||ANCOVA|||2 sided 5% test||0.0220|-0.0435|0.5175
72336405|NCT01509677|144196241|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.146|STANDARD_ERROR_OF_MEAN|3.3253||0.5205|TWO_SIDED|95.0|-4.466|8.757|||ANCOVA|||2-sided 5 % test||8.757|-4.466|0.5205
72336406|NCT01509677|144196242|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.141|STANDARD_ERROR_OF_MEAN|3.0057||0.7052|TWO_SIDED|95.0|-4.835|7.117|||ANCOVA|||2-sided 5 % test||7.117|-4.835|0.7052
72336407|NCT01509677|144196243|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.867|STANDARD_ERROR_OF_MEAN|0.7331||0.0127|TWO_SIDED|95.0|-3.324|-0.409|||ANCOVA|||2-sided 5 % test||-0.409|-3.324|0.0127
72336408|NCT01509677|144196244|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.051|STANDARD_ERROR_OF_MEAN|0.1871||0.7862|TWO_SIDED|95.0|-0.423|0.321|||ANCOVA|||2-sided 5 % test||0.321|-0.423|0.7862
72336409|NCT01509677|144196245|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.16|STANDARD_ERROR_OF_MEAN|1.005||0.8769|TWO_SIDED|95.0|-1.84|2.15|||ANCOVA|||2-sided 5% test||2.15|-1.84|0.8769
72336410|NCT01509677|144196246|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|711.1|STANDARD_ERROR_OF_MEAN|2768.79||0.7978|TWO_SIDED|95.0|-4778.3|6200.5|||ANCOVA|||2-sided 5% test||6200.5|-4778.3|0.7978
72336411|NCT01509677|144196247|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|88.5|STANDARD_ERROR_OF_MEAN|79.26||0.2669|TWO_SIDED|95.0|-68.6|245.6|||ANCOVA|||2-sided 5% test||245.6|-68.6|0.2669
72336412|NCT01509677|144196248|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-25.9|STANDARD_ERROR_OF_MEAN|67.78||0.7033|TWO_SIDED|95.0|-160.3|108.5|||ANCOVA|||2-sided 5% test||108.5|-160.3|0.7033
72336413|NCT01509677|144196249|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|27.79|STANDARD_ERROR_OF_MEAN|18.039||0.1264|TWO_SIDED|95.0|-7.97|63.55|||ANCOVA|||2-sided 5% test||63.55|-7.97|0.1264
72336414|NCT01509677|144196250|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|296.8|STANDARD_ERROR_OF_MEAN|124.07||0.0185|TWO_SIDED|95.0|50.9|542.7|||ANCOVA|||2-sided 5% test||542.7|50.9|0.0185
72336415|NCT01509677|144196251|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.086||0.9989|TWO_SIDED|95.0|-0.17|0.17|||ANCOVA|||2-sided 5% test||0.17|-0.17|0.9989
72336416|NCT01509677|144196252|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.56|STANDARD_ERROR_OF_MEAN|1.309||0.6701|TWO_SIDED|95.0|-3.15|2.03|||ANCOVA|||2-sided 5% test||2.03|-3.15|0.6701
72336417|NCT01509677|144196253|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.8|STANDARD_ERROR_OF_MEAN|1.1||0.1105|TWO_SIDED|95.0|-0.4|3.9|||ANCOVA|||2-sided 5% test||3.9|-0.4|0.1105
72336418|NCT01509677|144196254|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.5|STANDARD_ERROR_OF_MEAN|15.62||0.9261|TWO_SIDED|95.0|-32.4|29.5|||ANCOVA|||2-sided 5% test||29.5|-32.4|0.9261
72336419|NCT01509677|144196255|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|10.1|STANDARD_ERROR_OF_MEAN|4.49||0.0257|TWO_SIDED|95.0|1.2|19.0|||ANCOVA|||2-sided 5% test||19.0|1.2|0.0257
72336420|NCT01509677|144196256|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|32.8|STANDARD_ERROR_OF_MEAN|18.11||0.0728|TWO_SIDED|95.0|-3.0|168.6|||ANCOVA|||2-sided 5% test||168.6|-3.0|0.0728
72336421|NCT01509677|144196257|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.063|STANDARD_ERROR_OF_MEAN|0.03||0.038|TWO_SIDED|95.0|0.004|0.122|||ANCOVA|||2-sided 5% test||0.122|0.004|0.0380
72336422|NCT01509677|144196258|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.064|STANDARD_ERROR_OF_MEAN|0.0552||0.2482|TWO_SIDED|95.0|-0.045|0.173|||ANCOVA|||2-sided 5% test||0.173|-0.045|0.2482
72336423|NCT01509677|144196259|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-1.0||||0.2629|TWO_SIDED|95.0|-2.0|1.0|||Wilcoxon (Mann-Whitney)|Between treatment difference||2 sided 5 % test||1.00|-2.00|0.2629
72336424|NCT03549871|144196265|SUPERIORITY||ABR ratio|0.389|||=|0.0008|TWO_SIDED|95.0|0.224|0.675||The threshold for significance was \<0.05.|Repeated measures NB regression model|||Analyzed using repeated measures NB model with fixed effect of treatment period (fitusiran efficacy period or factor/BPA prophylaxis period) and robust sandwich covariance matrix was constructed to account for within participant dependence, logarithm of duration (in years) that each participant spends in each study period matching BE data being analyzed as an offset variable.||0.675|0.224|=0.0008
72336425|NCT03549871|144196267|SUPERIORITY||ABR ratio|0.444|||||TWO_SIDED|95.0|0.234|0.842||||||||0.842|0.234|
72336426|NCT03549871|144196269|SUPERIORITY||ABR ratio|0.485|||||TWO_SIDED|95.0|0.259|0.91||||||||0.910|0.259|
72336427|NCT00294645|144196289|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Modified Peto-Peto|A one-sided test was used.||Null hypothesis: control rate = remote rate||||<0.0001
72336428|NCT01057225|144196305|SUPERIORITY_OR_OTHER||Dose Level|1.0|||||TWO_SIDED||||||||Using a cohort of 3 design, it was determined the maximum tolerated dose of carfilzomib is Dose Level 1: 20 mg/m\^2 for the first cycle and 36 mg/m\^2 for subsequent cycles.|||||
72336429|NCT04600505|144196327|OTHER|Results based on linear mixed-effects analysis of variance model|Geometric mean Ratio (%)|111.7|||||TWO_SIDED|90.0|91.01|137.1||||||Statistical Comparison of Budesonide PK Parameters for Treatment A (test) versus Treatment C (reference)||137.1|91.01|
72336430|NCT04600505|144196327|OTHER|Results based on linear mixed-effects analysis of variance model|Geometric mean Ratio (%)|98.78|||||TWO_SIDED|90.0|78.67|124.0||||||Statistical Comparison of Budesonide PK Parameters for Treatment B (test) versus Treatment C (reference)||124.0|78.67|
72336431|NCT04600505|144196327|OTHER|Results based on linear mixed-effects analysis of variance model|Geometric mean Ratio (%)|108.3|||||TWO_SIDED|90.0|85.5|137.3||||||Statistical Comparison of Glycopyrronium PK Parameters for Treatment A (test) versus Treatment C (reference)||137.3|85.50|
72336432|NCT04600505|144196327|OTHER|Results based on linear mixed-effects analysis of variance model|Geometric mean Ratio (%)|94.88|||||TWO_SIDED|90.0|74.69|120.5||||||Statistical Comparison of Glycopyrronium PK Parameters for Treatment B (test) versus Treatment C (reference)||120.5|74.69|
72336433|NCT04600505|144196327|OTHER|Results based on linear mixed-effects analysis of variance model|Geometric mean Ratio (%)|109.1|||||TWO_SIDED|90.0|97.02|122.7||||||Statistical Comparison of Formoterol PK Parameters for Treatment A (test) versus Treatment C (reference)||122.7|97.02|
72336434|NCT04600505|144196327|OTHER|Results based on linear mixed-effects analysis of variance model|Geometric mean Ratio (%)|100.1||||||90.0|83.78|119.5||||||Statistical Comparison of Formoterol PK Parameters for Treatment B (test) versus Treatment C (reference)||119.5|83.78|
72336435|NCT04600505|144196328|OTHER|Results based on linear mixed-effects analysis of variance model|Geometric mean Ratio (%)|104.7|||||TWO_SIDED|90.0|91.95|119.2||||||Statistical Comparison of Budesonide PK Parameters for Treatment A (test) versus Treatment C (reference)||119.2|91.95|
72427456|NCT02942004|144367030|SUPERIORITY||LS mean difference|0.18|STANDARD_ERROR_OF_MEAN|0.24||0.4572|TWO_SIDED|95.0|-0.3|0.65|||MMRM|||Depressed Mood, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.65|-0.30|0.4572
72427457|NCT02942004|144367030|SUPERIORITY||LS mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.236||0.9866|TWO_SIDED|95.0|-0.47|0.46|||MMRM|||Depressed Mood, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.46|-0.47|0.9866
72427458|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.07|STANDARD_ERROR_OF_MEAN|0.229||0.749|TWO_SIDED|95.0|-0.53|0.38|||MMRM|||Depressed Mood, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.38|-0.53|0.7490
72427459|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.57|STANDARD_ERROR_OF_MEAN|0.247||0.0235|TWO_SIDED|95.0|-1.06|-0.08|||MMRM|||Depressed Mood, Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.08|-1.06|0.0235
72427460|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.02|STANDARD_ERROR_OF_MEAN|0.239||0.9286|TWO_SIDED|95.0|-0.5|0.45|||MMRM|||Depressed Mood, Change Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.45|-0.50|0.9286
72427461|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.49|STANDARD_ERROR_OF_MEAN|0.251||0.0544|TWO_SIDED|95.0|-0.99|0.01|||MMRM|||Depressed Mood, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.01|-0.99|0.0544
72427462|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.26|STANDARD_ERROR_OF_MEAN|0.244||0.2903|TWO_SIDED|95.0|-0.74|0.22|||MMRM|||Depressed Mood, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.22|-0.74|0.2903
72427463|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.71|STANDARD_ERROR_OF_MEAN|0.244||0.0044|TWO_SIDED|95.0|-1.19|-0.23|||MMRM|||Depressed Mood, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.23|-1.19|0.0044
72427464|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.36|STANDARD_ERROR_OF_MEAN|0.238||0.1339|TWO_SIDED|95.0|-0.83|0.11|||MMRM|||Depressed Mood, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.11|-0.83|0.1339
72427465|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.58|STANDARD_ERROR_OF_MEAN|0.234||0.0149|TWO_SIDED|95.0|-1.04|-0.11|||MMRM|||Depressed Mood, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.11|-1.04|0.0149
72336436|NCT04600505|144196328|OTHER|Results based on linear mixed-effects analysis of variance model|Geometric mean Ratio (%)|98.03|||||TWO_SIDED|90.0|83.33|115.3||||||Statistical Comparison of Budesonide PK Parameters for Treatment B (test) versus Treatment C (reference)||115.3|83.33|
72336437|NCT04600505|144196328|OTHER|Results based on linear mixed-effects analysis of variance model|Geometric mean Ratio (%)|96.0||||||90.0|70.33|131.0||||||Statistical Comparison of Formoterol PK Parameters for Treatment A (test) versus Treatment C (reference)||131.0|70.33|
72336438|NCT04600505|144196328|OTHER|Results based on linear mixed-effects analysis of variance model|Geometric mean Ratio (%)|116.7||||||90.0|86.31|157.8||||||Statistical Comparison of Formoterol PK Parameters for Treatment B (test) versus Treatment C (reference)||157.8|86.31|
72336439|NCT04600505|144196329|OTHER|Results based on linear mixed-effects analysis of variance model|Geometric mean Ratio (%)|107.3|||||TWO_SIDED|90.0|94.53|121.9||||||Statistical Comparison of Budesonide PK Parameters for Treatment A (test) versus Treatment C (reference)||121.9|94.53|
72336440|NCT04600505|144196329|OTHER|Results based on linear mixed-effects analysis of variance model|Geometric mean Ratio (%)|98.8|||||TWO_SIDED|90.0|84.59|115.4||||||Statistical Comparison of Budesonide PK Parameters for Treatment B (test) versus Treatment C (reference)||115.4|84.59|
72336441|NCT04600505|144196329|OTHER|Results based on linear mixed-effects analysis of variance model|Geometric mean Ratio (%)|106.1|||||TWO_SIDED|90.0|86.18|130.6||||||Statistical Comparison of Glycopyrronium PK Parameters for Treatment A (test) versus Treatment C (reference)||130.6|86.18|
72336442|NCT04600505|144196329|OTHER|Results based on linear mixed-effects analysis of variance model|Geometric mean Ratio (%)|99.71|||||TWO_SIDED|90.0|80.84|123.0||||||Statistical Comparison of Glycopyrronium PK Parameters for Treatment B (test) versus Treatment C (reference)||123.0|80.84|
72336443|NCT04600505|144196329|OTHER|Results based on linear mixed-effects analysis of variance model|Geometric mean Ratio (%)|98.13|||||TWO_SIDED|90.0|86.44|111.4||||||Statistical Comparison of Formoterol PK Parameters for Treatment A (test) versus Treatment C (reference)||111.4|86.44|
72336444|NCT04600505|144196329|OTHER|Results based on linear mixed-effects analysis of variance model|Geometric mean Ratio (%)|107.0|||||TWO_SIDED|90.0|88.82|128.9||||||Statistical Comparison of Formoterol PK Parameters for Treatment B (test) versus Treatment C (reference)||128.9|88.82|
72336445|NCT00871117|144196337|NON_INFERIORITY|Lower limit of the standardized asymptotic 95% confidence interval (CI) for the between-group differences in booster response to diphtheria was greater than or equal to (≥)-10%.|Difference in booster response rates|0.01|||||TWO_SIDED|95.0|-2.54|2.58||||||To demonstrate the non-inferiority of DTaP-IPV vaccine co-administered with Varicella and MMR vaccines compared to DTaP-IPV vaccine co-administered with MMR only in terms of diphtheria (D) booster response one month after vaccination with DTaP-IPV vaccine.||2.58|-2.54|
72336446|NCT00871117|144196337|NON_INFERIORITY|Lower limit of the standardized asymptotic 95% CI for the between-group differences in booster response to tetanus was ≥ -10%.|Difference in booster response rates|0.98|||||TWO_SIDED|95.0|-1.99|4.26||||||To demonstrate the non-inferiority of DTaP-IPV vaccine co-administered with Varicella and MMR vaccines compared to DTaP-IPV vaccine co-administered with MMR only in terms of tetanus (T) booster response one month after vaccination with DTaP-IPV vaccine.||4.26|-1.99|
72336447|NCT00871117|144196338|NON_INFERIORITY|Lower limit of the standardized asymptotic 95% CI for the between-group differences in booster response to PT was ≥ -10%|Difference in booster response rates|-0.76|||||TWO_SIDED|95.0|-5.07|3.51||||||To demonstrate the non-inferiority of DTaP-IPV vaccine co-administered with Varicella and MMR vaccines compared to DTaP-IPV vaccine co-administered with MMR only in terms of pertussis toxoid (PT) booster response one month after vaccination with DTaP-IPV vaccine.||3.51|-5.07|
72336448|NCT00871117|144196338|NON_INFERIORITY|Lower limit of the standardized asymptotic 95% CI for the between-group differences in booster response to FHA was ≥ -10%.|Difference in booster response rates|-0.91|||||TWO_SIDED|95.0|-3.59|1.39||||||To demonstrate the non-inferiority of DTaP-IPV vaccine co-administered with Varicella and MMR vaccines compared to DTaP-IPV vaccine co-administered with MMR only in terms of filamentous hemagglutinin (FHA) booster response one month after vaccination with DTaP-IPV vaccine.||1.39|-3.59|
72336449|NCT00871117|144196338|NON_INFERIORITY|Lower limit of the standardized asymptotic 95% CI for the between-group differences in booster response to PRN, was ≥ -10%.|Difference in booster response rates|1.42|||||TWO_SIDED|95.0|-0.32|4.08||||||To demonstrate the non-inferiority of DTaP-IPV vaccine co-administered with Varicella and MMR vaccines compared to DTaP-IPV vaccine co-administered with MMR only in terms of pertactin (PRN) booster response one month after vaccination with DTaP-IPV vaccine.||4.08|-0.32|
72336450|NCT00871117|144196339|NON_INFERIORITY|Lower limit of the 95% CI for the GMT ratios for poliovirus type 1 antigens was ≥ 0.67.|Adjusted GMT ratio|0.91|||||TWO_SIDED|95.0|0.76|1.1||||||To demonstrate the non-inferiority of DTaP-IPV vaccine co-administered with Varicella and MMR vaccines compared to DTaP-IPV vaccine co-administered with MMR only in terms of poliovirus type 1 geometric mean titers (GMTs), one month after vaccination with DTaP-IPV vaccine.||1.1|0.76|
72336451|NCT00871117|144196339|NON_INFERIORITY|Lower limit of the 95% CI for the GMT ratios of poliovirus type 2 antigens was ≥ 0.67.|Adjusted GMT ratio|0.83|||||TWO_SIDED|95.0|0.7|0.99||||||To demonstrate the non-inferiority of DTaP-IPV vaccine co-administered with Varicella and MMR vaccines compared to DTaP-IPV vaccine co-administered with MMR only in terms of poliovirus type 2 geometric mean titers (GMTs), one month after vaccination with DTaP-IPV vaccine.||0.99|0.7|
72336452|NCT00871117|144196339|NON_INFERIORITY|Lower limit of the 95% CI for the GMT ratios of poliovirus type 3 antigens was ≥ 0.67.|Adjusted GMT ratio|0.84|||||TWO_SIDED|95.0|0.71|1.01||||||To demonstrate the non-inferiority of DTaP-IPV vaccine co-administered with Varicella and MMR vaccines compared to DTaP-IPV vaccine co-administered with MMR only in terms of poliovirus type 3 geometric mean titers (GMTs), one month after vaccination with DTaP-IPV vaccine.||1.01|0.71|
72336453|NCT03385265|144196356|SUPERIORITY||partial eta squared|0.02|||||TWO_SIDED||||||repeated measures ANOVA|||||||
72336454|NCT03385265|144196357|SUPERIORITY||partial eta squared|0.12|||||TWO_SIDED||||||repeated measures ANOVA|CESD-R = within subject variable; group = between subject variable||||||
72336455|NCT03385265|144196358|SUPERIORITY||partial eta squared|0.03|||||TWO_SIDED||||||repeated measures ANOVA|||||||
72336456|NCT03385265|144196359|SUPERIORITY||partial eta squared|0.06|||||TWO_SIDED||||||repeated measures ANOVA|||||||
72336457|NCT03385265|144196360|SUPERIORITY||partial eta squared|0.04|||||TWO_SIDED||||||repeated measures ANOVA|||||||
72336458|NCT03385265|144196361|SUPERIORITY||partial eta squared|0.04|||<|0.05|TWO_SIDED||||||repeated measures ANOVA|||||||<0.05
72336459|NCT03385265|144196362|SUPERIORITY||partial eta squared|0.24|||||TWO_SIDED||||||repeated measures ANOVA|||||||
72336460|NCT03385265|144196363|SUPERIORITY||partial eta squared|0.03|||||TWO_SIDED||||||repeated measures ANOVA|||||||
72336461|NCT03385265|144196364|SUPERIORITY||partial eta squared|0.04|||||TWO_SIDED||||||repeated measures ANOVA|||||||
72336462|NCT02323204|144196370|OTHER|||||||0.6298|||||||Wald 2-sided t-test|||"A Generalized Linear Mixed Model (GLMM) with log link and gamma distribution was fit to five imputed data sets. Obtained estimates and standard errors were adjusted accordingly.~A comparison of intervention efficacy was made through the intervention-time interaction effect included in the model. Statistical significance of the interaction effect is indicative of a difference in effect between interventions over time."||||0.6298
72336463|NCT02323204|144196370|OTHER|||||||0.2341|||||||Wald 2-sided t-test|||"A Generalized Linear Mixed Model (GLMM) with log link and gamma distribution was fit to five imputed data sets. Obtained estimates and standard errors were adjusted accordingly.~A comparison of intervention efficacy was made through the intervention-time interaction effect included in the model. Statistical significance of the interaction effect is indicative of a difference in effect between interventions over time."||||0.2341
72336464|NCT02323204|144196371|OTHER|||||||0.7893|||||||Wald 2-sided t-test|||"A Generalized Linear Mixed Model (GLMM) with log link and gamma distribution was fit to five imputed data sets. Obtained estimates and standard errors were adjusted accordingly.~A comparison of intervention efficacy was made through the intervention-time interaction effect included in the model. Statistical significance of the interaction effect is indicative of a difference in effect between interventions over time."||||0.7893
72336465|NCT02323204|144196371|OTHER|||||||0.2951|||||||Wald 2-sided t-test|||"A Generalized Linear Mixed Model (GLMM) with log link and gamma distribution was fit to five imputed data sets. Obtained estimates and standard errors were adjusted accordingly.~A comparison of intervention efficacy was made through the intervention-time interaction effect included in the model. Statistical significance of the interaction effect is indicative of a difference in effect between interventions over time."||||0.2951
72336466|NCT02323204|144196372|OTHER|||||||0.7166|||||||Wald 2-sided t-test|||"A Generalized Linear Mixed Model (GLMM) with log link and gamma distribution was fit to five imputed data sets. Obtained estimates and standard errors were adjusted accordingly.~A comparison of intervention efficacy was made through the intervention-time interaction effect included in the model. Statistical significance of the interaction effect is indicative of a difference in effect between interventions over time."||||0.7166
72336467|NCT02323204|144196372|OTHER|||||||0.4501|||||||Wald 2-sided t-test|||"A Generalized Linear Mixed Model (GLMM) with log link and gamma distribution was fit to five imputed data sets. Obtained estimates and standard errors were adjusted accordingly.~A comparison of intervention efficacy was made through the intervention-time interaction effect included in the model. Statistical significance of the interaction effect is indicative of a difference in effect between interventions over time."||||0.4501
72336468|NCT02323204|144196373|OTHER|||||||0.6756|||||||Wald 2-sided t-test|||"A Generalized Linear Mixed Model (GLMM) with log link and gamma distribution was fit to five imputed data sets. Obtained estimates and standard errors were adjusted accordingly.~A comparison of intervention efficacy was made through the intervention-time interaction effect included in the model. Statistical significance of the interaction effect is indicative of a difference in effect between interventions over time."||||0.6756
72336469|NCT02323204|144196373|OTHER|||||||0.5381|||||||Wald 2-sided t-test|||"A Generalized Linear Mixed Model (GLMM) with log link and gamma distribution was fit to five imputed data sets. Obtained estimates and standard errors were adjusted accordingly.~A comparison of intervention efficacy was made through the intervention-time interaction effect included in the model. Statistical significance of the interaction effect is indicative of a difference in effect between interventions over time."||||0.5381
72336470|NCT02323204|144196374|OTHER|||||||0.1507|||||||Wald 2-sided t-test|||"A Generalized Linear Mixed Model (GLMM) with log link and gamma distribution was fit to five imputed data sets. Obtained estimates and standard errors were adjusted accordingly.~A comparison of intervention efficacy was made through the intervention-time interaction effect included in the model. Statistical significance of the interaction effect is indicative of a difference in effect between interventions over time."||||0.1507
72427466|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.23|STANDARD_ERROR_OF_MEAN|0.228||0.3213|TWO_SIDED|95.0|-0.68|0.22|||MMRM|||Depressed Mood, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.22|-0.68|0.3213
72427467|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.45|STANDARD_ERROR_OF_MEAN|0.246||0.0703|TWO_SIDED|95.0|-0.94|0.04|||MMRM|||Depressed Mood, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.04|-0.94|0.0703
72427468|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.06|STANDARD_ERROR_OF_MEAN|0.24||0.8152|TWO_SIDED|95.0|-0.53|0.42|||MMRM|||Depressed Mood, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.42|-0.53|0.8152
72427469|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.53|STANDARD_ERROR_OF_MEAN|0.301||0.0805|TWO_SIDED|95.0|-1.13|0.07|||MMRM|||Depressed Mood, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.07|-1.13|0.0805
72427470|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.11|STANDARD_ERROR_OF_MEAN|0.291||0.6964|TWO_SIDED|95.0|-0.69|0.46|||MMRM|||Depressed Mood, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.46|-0.69|0.6964
72427471|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.32|STANDARD_ERROR_OF_MEAN|0.304||0.2998|TWO_SIDED|95.0|-0.92|0.29|||MMRM|||Depressed Mood, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.29|-0.92|0.2998
72427472|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.28|STANDARD_ERROR_OF_MEAN|0.291||0.3448|TWO_SIDED|95.0|-0.85|0.3|||MMRM|||Depressed Mood, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.30|-0.85|0.3448
72336471|NCT02323204|144196374|OTHER|||||||0.0769|||||||Wald 2-sided t-test|||"A Generalized Linear Mixed Model (GLMM) with log link and gamma distribution was fit to five imputed data sets. Obtained estimates and standard errors were adjusted accordingly.~A comparison of intervention efficacy was made through the intervention-time interaction effect included in the model. Statistical significance of the interaction effect is indicative of a difference in effect between interventions over time."||||0.0769
72427473|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.66|STANDARD_ERROR_OF_MEAN|0.248||0.0089|TWO_SIDED|95.0|-1.15|-0.17|||MMRM|||Depressed Mood, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.17|-1.15|0.0089
72427474|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.44|STANDARD_ERROR_OF_MEAN|0.244||0.0772|TWO_SIDED|95.0|-0.92|0.05|||MMRM|||Depressed Mood, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.05|-0.92|0.0772
72427475|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.08|STANDARD_ERROR_OF_MEAN|0.191||0.6809|TWO_SIDED|95.0|-0.46|0.3|||MMRM|||Feelings of Guilt, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.30|-0.46|0.6809
72427476|NCT02942004|144367030|SUPERIORITY||LS mean difference|0.06|STANDARD_ERROR_OF_MEAN|0.185||0.7297|TWO_SIDED|95.0|-0.3|0.43|||MMRM|||Feelings of Guilt, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.43|-0.30|0.7297
72427477|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.43|STANDARD_ERROR_OF_MEAN|0.226||0.0626|TWO_SIDED|95.0|-0.87|0.02|||MMRM|||Feelings of Guilt, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.02|-0.87|0.0626
72427478|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.14|STANDARD_ERROR_OF_MEAN|0.22||0.5196|TWO_SIDED|95.0|-0.58|0.29|||MMRM|||Feelings of Guilt, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.29|-0.58|0.5196
72427479|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.42|STANDARD_ERROR_OF_MEAN|0.234||0.0772|TWO_SIDED|95.0|-0.88|0.05|||MMRM|||Feelings of Guilt, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.05|-0.88|0.0772
72427480|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.228||0.661|TWO_SIDED|95.0|-0.55|0.35|||MMRM|||Feelings of Guilt, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.35|-0.55|0.6610
72427481|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.239||0.4007|TWO_SIDED|95.0|-0.67|0.27|||MMRM|||Feelings of Guilt, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.27|-0.67|0.4007
72336472|NCT02323204|144196375|OTHER|||||||0.0654|||||||Wald 2-sided t-test|||"A Generalized Linear Mixed Model (GLMM) with log link and gamma distribution was fit to five imputed data sets. Obtained estimates and standard errors were adjusted accordingly.~A comparison of intervention efficacy was made through the intervention-time interaction effect included in the model. Statistical significance of the interaction effect is indicative of a difference in effect between interventions over time."||||0.0654
72427482|NCT02942004|144367030|SUPERIORITY||LS mean difference|0.28|STANDARD_ERROR_OF_MEAN|0.232||0.2292|TWO_SIDED|95.0|-0.18|0.74|||MMRM|||Feelings of Guilt, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.74|-0.18|0.2292
72427483|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.45|STANDARD_ERROR_OF_MEAN|0.234||0.054|TWO_SIDED|95.0|-0.92|0.01|||MMRM|||Feelings of Guilt, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.01|-0.92|0.0540
72427484|NCT02942004|144367030|SUPERIORITY||LS mean difference|0.01|STANDARD_ERROR_OF_MEAN|0.227||0.959|TWO_SIDED|95.0|-0.44|0.46|||MMRM|||Feelings of Guilt, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.46|-0.44|0.9590
72336473|NCT02323204|144196375|OTHER|||||||0.7957|||||||Wald 2-sided t-test|||"A Generalized Linear Mixed Model (GLMM) with log link and gamma distribution was fit to five imputed data sets. Obtained estimates and standard errors were adjusted accordingly.~A comparison of intervention efficacy was made through the intervention-time interaction effect included in the model. Statistical significance of the interaction effect is indicative of a difference in effect between interventions over time."||||0.7957
72336474|NCT02323204|144196376|OTHER|||||||0.0286|||||||Wald 2-sided t-test|||"A Generalized Linear Mixed Model (GLMM) with log link and gamma distribution was fit to five imputed data sets. Obtained estimates and standard errors were adjusted accordingly.~A comparison of intervention efficacy was made through the intervention-time interaction effect included in the model. Statistical significance of the interaction effect is indicative of a difference in effect between interventions over time."||||0.0286
72336475|NCT02323204|144196376|OTHER|||||||0.0201|||||||Wald 2-sided t-test|||"A Generalized Linear Mixed Model (GLMM) with log link and gamma distribution was fit to five imputed data sets. Obtained estimates and standard errors were adjusted accordingly.~A comparison of intervention efficacy was made through the intervention-time interaction effect included in the model. Statistical significance of the interaction effect is indicative of a difference in effect between interventions over time."||||0.0201
72336476|NCT02323204|144196377|OTHER|||||||0.9928|||||||Wald 2-sided t-test|||"A Generalized Linear Mixed Model (GLMM) with log link and gamma distribution was fit to five imputed data sets. Obtained estimates and standard errors were adjusted accordingly.~A comparison of intervention efficacy was made through the intervention-time interaction effect included in the model. Statistical significance of the interaction effect is indicative of a difference in effect between interventions over time."||||0.9928
72336477|NCT02323204|144196377|OTHER|||||||0.0982|||||||Wald 2-sided t-test|||"A Generalized Linear Mixed Model (GLMM) with log link and gamma distribution was fit to five imputed data sets. Obtained estimates and standard errors were adjusted accordingly.~A comparison of intervention efficacy was made through the intervention-time interaction effect included in the model. Statistical significance of the interaction effect is indicative of a difference in effect between interventions over time."||||0.0982
72336478|NCT02323204|144196378|OTHER|||||||0.0325|||||||Wald 2-sided t-test|||"A Generalized Linear Mixed Model (GLMM) with log link and gamma distribution was fit to five imputed data sets. Obtained estimates and standard errors were adjusted accordingly.~A comparison of intervention efficacy was made through the intervention-time interaction effect included in the model. Statistical significance of the interaction effect is indicative of a difference in effect between interventions over time."||||0.0325
72336479|NCT02323204|144196378|OTHER|||||||0.2568|||||||Wald 2-sided t-test|||"A Generalized Linear Mixed Model (GLMM) with log link and gamma distribution was fit to five imputed data sets. Obtained estimates and standard errors were adjusted accordingly.~A comparison of intervention efficacy was made through the intervention-time interaction effect included in the model. Statistical significance of the interaction effect is indicative of a difference in effect between interventions over time."||||0.2568
72336480|NCT02323204|144196379|OTHER|||||||0.5824|||||||Wald 2-sided t-test|||"A Generalized Linear Mixed Model (GLMM) with log link and gamma distribution was fit to five imputed data sets. Obtained estimates and standard errors were adjusted accordingly.~A comparison of intervention efficacy was made through the intervention-time interaction effect included in the model. Statistical significance of the interaction effect is indicative of a difference in effect between interventions over time."||||0.5824
72336481|NCT02323204|144196379|OTHER|||||||0.4635|||||||Wald 2-sided t-test|||"A Generalized Linear Mixed Model (GLMM) with log link and gamma distribution was fit to five imputed data sets. Obtained estimates and standard errors were adjusted accordingly.~A comparison of intervention efficacy was made through the intervention-time interaction effect included in the model. Statistical significance of the interaction effect is indicative of a difference in effect between interventions over time."||||0.4635
72336482|NCT02323204|144196380|OTHER|||||||0.7949|||||||Wald 2-sided t-test|||A Generalized Linear Mixed Model (GLMM) with cumulative logit link and multinomial distribution was fit to the data. A comparison of implementation over time between interventions was made through the intervention-time interaction effect included in the model. Significance in the interaction effect is indicative of a difference in the rate of change in implementation between interventions over time.||||0.7949
72336483|NCT02323204|144196380|OTHER|||||||0.0003|||||||Wald 2-sided t-test|||A Generalized Linear Mixed Model (GLMM) with cumulative logit link and multinomial distribution was fit to the data. A comparison of implementation between interventions was made through the intervention main effect included in the model. The model at hand does not contain an interaction between intervention and time. Significance in the main intervention effect is indicative of a difference in implementation between intervention groups.||||0.0003
72336484|NCT01852825|144196381|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|2.355||||0.003|TWO_SIDED|90.0|1.515|3.661|||Constrained Longitudinal Data Analysis||MK-8237 treatment divided by Placebo treatment|The hypothesis is supported if the lower bound of the two-sided 90% confidence interval for the Week 12 geometric mean fold difference is \>1.0.||3.661|1.515|0.003
72336485|NCT01852825|144196382|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|2.182||||0.01|TWO_SIDED|90.0|1.364|3.49|||Constrained Longitudinal Data Analysis||MK-8237 treatment divided by Placebo treatment|The hypothesis is supported if the lower bound of the two-sided 90% confidence interval for the Week 12 geometric mean fold difference is \>1.0.||3.490|1.364|0.010
72336486|NCT01852825|144196383|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.238||||0.027|TWO_SIDED|90.0|0.066|0.41|||Constrained Longitudinal Data Analysis||MK-8237 treatment minus Placebo treatment|The hypothesis is supported if the lower bound of the 1-tailed 95% CI around the mean difference in change from baseline excludes zero||0.410|0.066|0.027
72336487|NCT01852825|144196384|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.068||||0.935|TWO_SIDED|90.0|0.272|4.19|||Constrained Longitudinal Data Analysis||MK-8237 treatment divided by Placebo treatment|||4.190|0.272|0.935
72336488|NCT01852825|144196385|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|2.21||||0.296|TWO_SIDED|90.0|0.605|8.066|||Constrained Longitudinal Data Analysis||MK-8237 treatment divided by Placebo treatment|||8.066|0.605|0.296
72336489|NCT01852825|144196386|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-61.115||||0.014|TWO_SIDED|90.0|-100.185|-22.045|||Constrained Longitudinal Data Analysis||MK-8237 treatment minus Placebo treatment|||-22.045|-100.185|0.014
72336490|NCT01327274|144196389|OTHER|Pre-treatment and post-treatment Pectus Severity Indices were compared using the Wilcoxon matched-pairs signed rank test.||||||0.486|||||||Wilcoxon (Mann-Whitney)|||||||0.486
72336491|NCT01095653|144196396|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.75|STANDARD_ERROR_OF_MEAN|0.0975|<|0.0001|TWO_SIDED|95.0|-0.94|-0.56||Primary endpoints were tested at alpha=0.027 applying Dunnett's adjustment|ANCOVA|||||-0.56|-0.94|<0.0001
72427485|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.36|STANDARD_ERROR_OF_MEAN|0.218||0.1048|TWO_SIDED|95.0|-0.79|0.08|||MMRM|||Feelings of Guilt, Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.08|-0.79|0.1048
72427486|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.03|STANDARD_ERROR_OF_MEAN|0.21||0.8979|TWO_SIDED|95.0|-0.44|0.39|||MMRM|||Feelings of Guilt, Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.39|-0.44|0.8979
72427487|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.38|STANDARD_ERROR_OF_MEAN|0.219||0.0819|TWO_SIDED|95.0|-0.82|0.05|||MMRM|||Feelings of Guilt, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.05|-0.82|0.0819
72427488|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.34|STANDARD_ERROR_OF_MEAN|0.213||0.1099|TWO_SIDED|95.0|-0.77|0.08|||MMRM|||Feelings of Guilt, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.08|-0.77|0.1099
72427489|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.45|STANDARD_ERROR_OF_MEAN|0.215||0.0373|TWO_SIDED|95.0|-0.88|-0.03|||MMRM|||Feelings of Guilt, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.03|-0.88|0.0373
72427490|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.209||0.0577|TWO_SIDED|95.0|-0.81|0.01|||MMRM|||Feelings of Guilt, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.01|-0.81|0.0577
72427491|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.27|STANDARD_ERROR_OF_MEAN|0.21||0.2023|TWO_SIDED|95.0|-0.69|0.15|||MMRM|||Feelings of Guilt, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.15|-0.69|0.2023
72427492|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.16|STANDARD_ERROR_OF_MEAN|0.204||0.4444|TWO_SIDED|95.0|-0.56|0.25|||MMRM|||Feelings of Guilt, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.25|-0.56|0.4444
72427493|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.22||0.3645|TWO_SIDED|95.0|-0.64|0.24|||MMRM|||Feelings of Guilt, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.24|-0.64|0.3645
72336492|NCT01095653|144196396|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.82|STANDARD_ERROR_OF_MEAN|0.0962|<|0.0001|TWO_SIDED|95.0|-1.01|-0.63||Primary endpoints were tested at alpha=0.027 applying Dunnett's adjustment|ANCOVA|||||-0.63|-1.01|<0.0001
72336493|NCT01095653|144196397|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-27.7|STANDARD_ERROR_OF_MEAN|3.203|<|0.0001|TWO_SIDED|95.0|-34.0|-21.4||Secondary endpoints were tested following a sequential testing procedure at alpha=0.05|ANCOVA|||||-21.4|-34.0|<0.0001
72336494|NCT01095653|144196397|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-34.2|STANDARD_ERROR_OF_MEAN|3.174|<|0.0001|TWO_SIDED|95.0|-40.4|-27.9||Secondary endpoints were tested following a sequential testing procedure at alpha=0.05|ANCOVA|||||-27.9|-40.4|<0.0001
72336495|NCT01095653|144196398|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-47.9|STANDARD_ERROR_OF_MEAN|6.5667|<|0.0001|TWO_SIDED|95.0|-60.8|-34.96||Secondary endpoints were tested following a sequential testing procedure at alpha=0.05|ANCOVA|||||-34.96|-60.80|<0.0001
72336496|NCT01095653|144196398|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-56.0|STANDARD_ERROR_OF_MEAN|6.4489|<|0.0001|TWO_SIDED|95.0|-68.66|-43.28||Secondary endpoints were tested following a sequential testing procedure at alpha=0.05|ANCOVA|||||-43.28|-68.66|<0.0001
72336497|NCT01095653|144196399|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.37|STANDARD_ERROR_OF_MEAN|0.3259|<|0.0001|TWO_SIDED|95.0|-2.01|-0.73||Secondary endpoints were tested following a sequential testing procedure at alpha=0.05|ANCOVA|||||-0.73|-2.01|<0.0001
72336498|NCT01095653|144196399|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.98|STANDARD_ERROR_OF_MEAN|0.3242|<|0.0001|TWO_SIDED|95.0|-2.62|-1.34||Secondary endpoints were tested following a sequential testing procedure at alpha=0.05|ANCOVA|||||-1.34|-2.62|<0.0001
72336499|NCT01095653|144196400|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|21.3|STANDARD_ERROR_OF_MEAN|5.238|<|0.0001|TWO_SIDED|95.0|11.1|31.6||Secondary endpoints were tested following a sequential testing procedure at alpha=0.05|Modified logistic regression|||||31.6|11.1|<0.0001
72336500|NCT01095653|144196400|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|28.5|STANDARD_ERROR_OF_MEAN|5.022|<|0.0001|TWO_SIDED|95.0|18.6|38.3||Secondary endpoints were tested following a sequential testing procedure at alpha=0.05|Modified logistic regression|||||38.3|18.6|<0.0001
72336501|NCT02752958|144196406|OTHER||Mean Difference (Final Values)|5.89||||0.0944|TWO_SIDED|95.0|-1.018|12.8|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|Difference is the baseline score minus Week 4 score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 (Baseline ) versus (vs.) Week 4||12.80|-1.018|0.0944
72336502|NCT02752958|144196407|OTHER||Mean Difference (Final Values)|16.99|||<|0.0001|TWO_SIDED|95.0|10.128|23.849|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 (baseline) vs. Week 8||23.849|10.128|<0.0001
72336503|NCT02752958|144196408|OTHER||Mean Difference (Final Values)|22.7|||<|0.0001|TWO_SIDED|95.0|15.87|29.539|||ANOVA|From ANOVA model with visit and site as fixed effect and participant as random effect. Visit\*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 (baseline) vs. Week 12||29.539|15.870|<0.0001
72336504|NCT02752958|144196409|OTHER||Mean Difference (Final Values)|27.21|||<|0.0001|TWO_SIDED|95.0|20.245|34.165|||ANOVA|From ANOVA model with visit and site as fixed effect and participant as random effect. Visit\*site interaction included where significant at 10% level|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 (baseline) vs. Week 16||34.165|20.245|<0.0001
72336505|NCT02752958|144196410|OTHER||Mean Difference (Final Values)|31.42|||<|0.0001|TWO_SIDED|95.0|24.464|38.385|||ANOVA|From ANOVA model with visit and site as fixed effect and participant as random effect. Visit\*site interaction included where significant at 10% level.||Week 0 Vs Week 20||38.385|24.464|<.0001
72336506|NCT02752958|144196411|OTHER||Mean Difference (Final Values)|32.55|||<|0.0001|TWO_SIDED|95.0|25.585|39.506|||ANOVA|From ANOVA model with visit and site as fixed effect and participant as random effect. Visit\*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 (baseline) vs. Week 24||39.506|25.585|<.0001
72336507|NCT02752958|144196412|OTHER||Mean Difference (Final Values)|1.18||||0.0312|TWO_SIDED|95.0|0.108|2.262|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 Vs. Week 4||2.262|0.108|0.0312
72336508|NCT02752958|144196413|OTHER||Mean Difference (Final Values)|2.8|||<|0.0001|TWO_SIDED|95.0|1.728|3.866|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|"Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice.~Week 0 = Baseline Value"|Week 0 Vs Week 8||3.866|1.728|<.0001
72336509|NCT02752958|144196414|OTHER||Mean Difference (Final Values)|3.26|||<|0.0001|TWO_SIDED|95.0|2.192|4.322|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 Vs. Week 12||4.322|2.192|<.0001
72336510|NCT02752958|144196415|OTHER||Mean Difference (Final Values)|3.93|||<|0.0001|TWO_SIDED|95.0|2.844|5.012|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|||5.012|2.844|<.0001
72336511|NCT02752958|144196416|OTHER||Mean Difference (Final Values)|4.15|||<|0.0001|TWO_SIDED|95.0|3.063|5.232|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 Vs. Week 20||5.232|3.063|<.0001
72427494|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.18|STANDARD_ERROR_OF_MEAN|0.214||0.4035|TWO_SIDED|95.0|-0.6|0.24|||MMRM|||Feelings of Guilt, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.24|-0.60|0.4035
72427495|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.16|STANDARD_ERROR_OF_MEAN|0.232||0.4877|TWO_SIDED|95.0|-0.62|0.3|||MMRM|||Feelings of Guilt, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.30|-0.62|0.4877
72427496|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.23|STANDARD_ERROR_OF_MEAN|0.226||0.3134|TWO_SIDED|95.0|-0.68|0.22|||MMRM|||Feelings of Guilt, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.22|-0.68|0.3134
72427497|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.41|STANDARD_ERROR_OF_MEAN|0.24||0.0922|TWO_SIDED|95.0|-0.89|0.07|||MMRM|||Feelings of Guilt, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.07|-0.89|0.0922
72427498|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.41|STANDARD_ERROR_OF_MEAN|0.23||0.0761|TWO_SIDED|95.0|-0.87|0.04|||MMRM|||Feelings of Guilt, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.04|-0.87|0.0761
72427499|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.21|STANDARD_ERROR_OF_MEAN|0.217||0.3275|TWO_SIDED|95.0|-0.64|0.22|||MMRM|||Feelings of Guilt, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.22|-0.64|0.3275
72427500|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.22|STANDARD_ERROR_OF_MEAN|0.213||0.3041|TWO_SIDED|95.0|-0.64|0.2|||MMRM|||Feelings of Guilt, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.20|-0.64|0.3041
72427501|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.146||0.045|TWO_SIDED|95.0|-0.59|-0.01|||MMRM|||Suicide, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.01|-0.59|0.0450
72427502|NCT02942004|144367030|SUPERIORITY||LS mean difference|0.09|STANDARD_ERROR_OF_MEAN|0.143||0.5351|TWO_SIDED|95.0|-0.19|0.37|||MMRM|||Suicide, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.37|-0.19|0.5351
72427503|NCT02942004|144367030|SUPERIORITY||LS men difference|-0.28|STANDARD_ERROR_OF_MEAN|0.142||0.0525|TWO_SIDED|95.0|-0.56|0.0|||MMRM|||Suicide, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.00|-0.56|0.0525
72427504|NCT02942004|144367030|SUPERIORITY||LS mean difference|0.04|STANDARD_ERROR_OF_MEAN|0.139||0.7932|TWO_SIDED|95.0|-0.24|0.31|||MMRM|||Suicide, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.31|-0.24|0.7932
72427505|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.128||0.13|TWO_SIDED|95.0|-0.45|0.06|||MMRM|||Suicide, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.06|-0.45|0.1300
72336512|NCT02752958|144196417|OTHER||Mean Difference (Final Values)|4.74|||<|0.0001|TWO_SIDED|95.0|3.654|5.823|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 Vs Week 24||5.823|3.654|<.0001
72336513|NCT02752958|144196418|OTHER||Mean Difference (Final Values)|1.11||||0.4185|TWO_SIDED|95.0|-1.592|3.821|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline|Week 0 Vs Week 4||3.821|-1.592|0.4185
72336514|NCT02752958|144196419|OTHER||Mean Difference (Final Values)|7.08|||<|0.0001|TWO_SIDED|95.0|4.391|9.764|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 Vs Week 8||9.764|4.391|<.0001
72336515|NCT02752958|144196420|OTHER||Mean Difference (Final Values)|8.35|||<|0.0001|TWO_SIDED|95.0|5.674|11.026|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Valu|Week 0 Vs Week 12||11.026|5.674|<.0001
72336516|NCT02752958|144196421|OTHER|Week 0 Vs Week 16|Mean Difference (Final Values)|10.43|||<|0.0001|TWO_SIDED|95.0|7.708|13.158|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 Vs Week 16||13.158|7.708|<.0001
72336517|NCT02752958|144196422|OTHER||Mean Difference (Final Values)|11.73|||<|0.0001|TWO_SIDED|95.0|9.008|14.459|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 Vs Week 20||14.459|9.008|<.0001
72336518|NCT02752958|144196423|OTHER||Mean Difference (Final Values)|11.96|||<|0.0001|TWO_SIDED|95.0|9.235|14.686|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 Vs Week 24||14.686|9.235|<.0001
72336519|NCT02752958|144196424|OTHER||Mean Difference (Final Values)|0.57||||0.3415|TWO_SIDED|95.0|-0.604|1.738|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|"Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice.~Week 0 = Baseline Value"|Week 0 vs Week 4||1.738|-0.604|0.3415
72336520|NCT02752958|144196425|OTHER||Mean Difference (Final Values)|1.77||||0.0029|TWO_SIDED|95.0|0.61|2.935|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline|Week 0 Vs Week 8||2.935|0.610|0.0029
72336521|NCT02752958|144196426|OTHER||Mean Difference (Final Values)|2.42|||<|0.0001|TWO_SIDED|95.0|1.266|3.582|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 Vs Week 12||3.582|1.266|<0.0001
72336522|NCT02752958|144196427|OTHER||Mean Difference (Final Values)|3.55|||<|0.0001|TWO_SIDED|95.0|2.371|4.729|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|"Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice.~Week 0 = Baseline Value"|Week 0 vs Week 16||4.729|2.371|<.0001
72336523|NCT02752958|144196428|OTHER||Mean Difference (Final Values)|4.39|||<|0.0001|TWO_SIDED|95.0|3.21|5.568|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 Vs Week 20||5.568|3.210|<0.0001
72336524|NCT02752958|144196429|OTHER||Mean Difference (Final Values)|4.3|||<|0.0001|TWO_SIDED|95.0|3.119|5.477|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 Vs Week 24||5.477|3.119|<0.0001
72336525|NCT02752958|144196430|OTHER||Mean Difference (Final Values)|2.42||||0.0145|TWO_SIDED|95.0|0.483|4.352|||ANOVA||Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 Vs Week 4||4.352|0.483|0.0145
72336526|NCT02752958|144196431|OTHER||Mean Difference (Final Values)|4.42|||<|0.0001|TWO_SIDED|95.0|2.498|6.339|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 Vs Week 8||6.339|2.498|<0.0001
72336527|NCT02752958|144196432|OTHER||Mean Difference (Final Values)|6.85|||<|0.0001|TWO_SIDED|95.0|4.933|8.759|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 Vs Week 12||8.759|4.933|<0.0001
72336528|NCT02752958|144196433|OTHER||Mean Difference (Final Values)|7.17|||<|0.0001|TWO_SIDED|95.0|5.219|9.115|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 Vs Week 16||9.115|5.219|<.0001
72427506|NCT02942004|144367030|SUPERIORITY||LS mean difference|0.17|STANDARD_ERROR_OF_MEAN|0.125||0.1631|TWO_SIDED|95.0|-0.07|0.42|||MMRM|||Suicide, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.42|-0.07|0.1631
72427507|NCT02942004|144367030|SUPERIORITY||LS mean difference|0.03|STANDARD_ERROR_OF_MEAN|0.129||0.8215|TWO_SIDED|95.0|-0.23|0.29|||MMRM|||Suicide, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.29|-0.23|0.8215
72427508|NCT02942004|144367030|SUPERIORITY||LS mean difference|0.26|STANDARD_ERROR_OF_MEAN|0.126||0.038|TWO_SIDED|95.0|0.01|0.51|||MMRM|||Suicide, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.51|0.01|0.0380
72427509|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.08|STANDARD_ERROR_OF_MEAN|0.124||0.507|TWO_SIDED|95.0|-0.33|0.16|||MMRM|||Suicide, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.16|-0.33|0.5070
72427510|NCT02942004|144367030|SUPERIORITY||LS mean difference|0.19|STANDARD_ERROR_OF_MEAN|0.12||0.1094|TWO_SIDED|95.0|-0.04|0.43|||MMRM|||Suicide, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.43|-0.04|0.1094
72427511|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.099||0.3112|TWO_SIDED|95.0|-0.3|0.1|||MMRM|||Suicide, Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.10|-0.30|0.3112
72427512|NCT02942004|144367030|SUPERIORITY||LS mean difference|0.14|STANDARD_ERROR_OF_MEAN|0.096||0.1345|TWO_SIDED|95.0|-0.05|0.33|||MMRM|||Suicide, Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.33|-0.05|0.1345
72427513|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.06|STANDARD_ERROR_OF_MEAN|0.091||0.5148|TWO_SIDED|95.0|-0.24|0.12|||MMRM|||Suicide, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.12|-0.24|0.5148
72427514|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.08|STANDARD_ERROR_OF_MEAN|0.088||0.3863|TWO_SIDED|95.0|-0.25|0.1|||MMRM|||Suicide, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.10|-0.25|0.3863
72427515|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.22|STANDARD_ERROR_OF_MEAN|0.094||0.0209|TWO_SIDED|95.0|-0.41|-0.03|||MMRM|||Suicide, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.03|-0.41|0.0209
72427516|NCT02942004|144367030|SUPERIORITY||LS men difference|-0.17|STANDARD_ERROR_OF_MEAN|0.092||0.0616|TWO_SIDED|95.0|-0.35|0.01|||MMRM|||Suicide, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.01|-0.35|0.0616
72427517|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.13|STANDARD_ERROR_OF_MEAN|0.099||0.186|TWO_SIDED|95.0|-0.33|0.06|||MMRM|||Suicide, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.06|-0.33|0.1860
72427518|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.03|STANDARD_ERROR_OF_MEAN|0.095||0.773|TWO_SIDED|95.0|-0.22|0.16|||MMRM|||Suicide, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.16|-0.22|0.7730
72336529|NCT02752958|144196434|OTHER||Mean Difference (Final Values)|8.39|||<|0.0001|TWO_SIDED|95.0|6.438|10.335|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 Vs Week 20||10.335|6.438|<0.0001
72336530|NCT02752958|144196435|OTHER||Mean Difference (Final Values)|8.67|||<|0.0001|TWO_SIDED|95.0|6.726|10.623|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 Vs. Week 24||10.623|6.726|<0.0001
72427519|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.18|STANDARD_ERROR_OF_MEAN|0.129||0.1593|TWO_SIDED|95.0|-0.44|0.07|||MMRM|||Suicide, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.07|-0.44|0.1593
72336531|NCT02752958|144196436|OTHER||Mean Difference (Final Values)|0.63||||0.3676|TWO_SIDED|95.0|-0.738|1.989|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 Vs Week 4||1.989|-0.738|0.3676
72427520|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.06|STANDARD_ERROR_OF_MEAN|0.126||0.6371|TWO_SIDED|95.0|-0.31|0.19|||MMRM|||Suicide, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.19|-0.31|0.6371
72427521|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.07|STANDARD_ERROR_OF_MEAN|0.124||0.5655|TWO_SIDED|95.0|-0.32|0.18|||MMRM|||Suicide, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.18|-0.32|0.5655
72427522|NCT02942004|144367030|SUPERIORITY||LS mean difference|0.12|STANDARD_ERROR_OF_MEAN|0.121||0.3326|TWO_SIDED|95.0|-0.12|0.36|||MMRM|||Suicide, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.36|-0.12|0.3326
72427523|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.19|STANDARD_ERROR_OF_MEAN|0.201||0.3577|TWO_SIDED|95.0|-0.59|0.22|||MMRM|||Suicide, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.22|-0.59|0.3577
72427524|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.27|STANDARD_ERROR_OF_MEAN|0.192||0.1646|TWO_SIDED|95.0|-0.66|0.11|||MMRM|||Suicide, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.11|-0.66|0.1646
72427525|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.23|STANDARD_ERROR_OF_MEAN|0.118||0.0545|TWO_SIDED|95.0|-0.46|0.0|||MMRM|||Suicide, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.00|-0.46|0.0545
72427526|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.12|STANDARD_ERROR_OF_MEAN|0.115||0.2903|TWO_SIDED|95.0|-0.35|0.11|||MMRM|||Suicide, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.11|-0.35|0.2903
72427527|NCT02942004|144367030|SUPERIORITY||LS mean difference|0.23|STANDARD_ERROR_OF_MEAN|0.112||0.0395|TWO_SIDED|95.0|0.01|0.45|||MMRM|||Insomnia - Early, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.45|0.01|0.0395
72427528|NCT02942004|144367030|SUPERIORITY||LS mean difference|0.08|STANDARD_ERROR_OF_MEAN|0.108||0.469|TWO_SIDED|95.0|-0.14|0.29|||MMRM|||Insomnia - Early, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.29|-0.14|0.4690
72336532|NCT02752958|144196437|OTHER||Mean Difference (Final Values)|0.9||||0.1907|TWO_SIDED|95.0|-0.451|2.255|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|"Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice.~Week 0 = Baseline Value"|Week 0 Vs Week 8||2.255|-0.451|0.1907
72336533|NCT02752958|144196438|OTHER||Mean Difference (Final Values)|1.81||||0.0085|TWO_SIDED|95.0|0.467|3.162|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 Vs. Week 12||3.162|0.467|0.0085
72336534|NCT02752958|144196439|OTHER||Mean Difference (Final Values)|2.12||||0.0026|TWO_SIDED|95.0|0.744|3.489|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|"Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice.~Week 0 = Baseline Value"|Week 0 Vs Week 16||3.489|0.744|0.0026
72336535|NCT02752958|144196440|OTHER||Mean Difference (Final Values)|2.74||||0.0001|TWO_SIDED|95.0|1.371|4.116|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.||Week 0 Vs Week 20||4.116|1.371|0.0001
72336536|NCT02752958|144196441|OTHER||Mean Difference (Final Values)|2.85|||<|0.0001|TWO_SIDED|95.0|1.477|4.222|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|"Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice.~Week 0 = Baseline Value"|Week 0 vs Week 24||4.222|1.477|<.0001
72336537|NCT02752958|144196442|OTHER||Mean Difference (Final Values)|0.09||||0.2326|TWO_SIDED|95.0|-0.059|0.243|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Valu|Week 0 Vs Week 4||0.243|-0.059|0.2326
72336538|NCT02752958|144196443|OTHER||Mean Difference (Final Values)|0.07||||0.3934|TWO_SIDED|95.0|-0.085|0.216||From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|ANOVA||Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 vs Week 8||0.216|-0.085|0.3934
72336539|NCT02752958|144196444|OTHER||Mean Difference (Final Values)|0.13||||0.0795|TWO_SIDED|95.0|-0.016|0.284|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 Vs Week 12||0.284|-0.016|0.0795
72336540|NCT02752958|144196445|OTHER||Mean Difference (Final Values)|0.14||||0.0682|TWO_SIDED|95.0|-0.011|0.294|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|"Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice.~Week 0 = Baseline Value"|Week 0 vs Week 16||0.294|-0.011|0.0682
72336541|NCT02752958|144196446|OTHER||Mean Difference (Final Values)|0.13||||0.0844|TWO_SIDED|95.0|-0.018|0.287|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 vs Week 20||0.287|-0.018|0.0844
72336542|NCT02752958|144196447|OTHER||Mean Difference (Final Values)|0.18||||0.0211|TWO_SIDED|95.0|0.027|0.332|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|"Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice.~Week 0 = Baseline Value"|Week 0 Vs Week 24||0.332|0.027|0.0211
72336543|NCT02752958|144196448|OTHER||Mean Difference (Final Values)|0.6||||0.0493|TWO_SIDED|95.0|0.002|1.194|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 vs Week 4||1.194|0.002|0.0493
72336544|NCT02752958|144196449|OTHER||Mean Difference (Final Values)|1.42|||<|0.0001|TWO_SIDED|95.0|0.83|2.013|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 vs Week 8||2.013|0.830|<0.0001
72336545|NCT02752958|144196450|OTHER||Mean Difference (Final Values)|1.87|||<|0.0001|TWO_SIDED|95.0|1.278|2.457||From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|ANOVA||Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 Vs Week 12||2.457|1.278|<0.0001
72336546|NCT02752958|144196451|OTHER||Mean Difference (Final Values)|2.03|||<|0.0001|TWO_SIDED|95.0|1.429|2.629|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|"Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice.~Week 0 = Baseline Value"|Week 0 Vs Week 16||2.629|1.429|<.0001
72336547|NCT02752958|144196452|OTHER||Mean Difference (Final Values)|2.34|||<|0.0001|TWO_SIDED|95.0|1.743|2.943|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 Vs Week 20||2.943|1.743|<.0001
72427529|NCT02942004|144367030|SUPERIORITY||LS difference|0.07|STANDARD_ERROR_OF_MEAN|0.139||0.6066|TWO_SIDED|95.0|-0.2|0.35|||MMRM|||Insomnia - Early, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.35|-0.20|0.6066
72427530|NCT02942004|144367030|SUPERIORITY||LS mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.136||0.9737|TWO_SIDED|95.0|-0.26|0.27|||MMRM|||Insomnia - Early, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.27|-0.26|0.9737
72427531|NCT02942004|144367030|SUPERIORITY||LS mean difference|0.12|STANDARD_ERROR_OF_MEAN|0.148||0.403|TWO_SIDED|95.0|-0.17|0.42|||MMRM|||Insomnia - Early, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.42|-0.17|0.4030
72427532|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.07|STANDARD_ERROR_OF_MEAN|0.145||0.6357|TWO_SIDED|95.0|-0.36|0.22|||MMRM|||Insomnia - Early, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.22|-0.36|0.6357
72427533|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.02|STANDARD_ERROR_OF_MEAN|0.134||0.8605|TWO_SIDED|95.0|-0.29|0.24|||MMRM|||Insomnia - Early, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.24|-0.29|0.8605
72427534|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.04|STANDARD_ERROR_OF_MEAN|0.13||0.7534|TWO_SIDED|95.0|-0.3|0.22|||MMRM|||Insomnia - Early, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.22|-0.30|0.7534
72427535|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.63|STANDARD_ERROR_OF_MEAN|0.201||0.0021|TWO_SIDED|95.0|-1.03|-0.23|||MMRM|||Insomnia - Early, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.23|-1.03|0.0021
72336548|NCT02752958|144196453|OTHER||Mean Difference (Final Values)|2.34|||<|0.0001|TWO_SIDED|95.0|1.743|2.943|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 Vs Week 24||2.943|1.743|<.0001
72336549|NCT02752958|144196454|OTHER||Mean Difference (Final Values)|0.88|||<|0.0001|TWO_SIDED|95.0|0.474|1.295|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 Vs Week 4||1.295|0.474|<.0001
72336550|NCT02752958|144196455|OTHER||Mean Difference (Final Values)|1.28|||<|0.0001|TWO_SIDED|95.0|0.875|1.69|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 Vs Week 8||1.690|0.875|<.0001
72427536|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.41|STANDARD_ERROR_OF_MEAN|0.196||0.0394|TWO_SIDED|95.0|-0.8|-0.02|||MMRM|||Insomnia - Early, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.02|-0.80|0.0394
72427537|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.61|STANDARD_ERROR_OF_MEAN|0.208||0.0039|TWO_SIDED|95.0|-1.03|-0.2|||Wilcoxon (Mann-Whitney)|||Insomnia - Early, Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.20|-1.03|0.0039
72427538|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.29|STANDARD_ERROR_OF_MEAN|0.202||0.1591|TWO_SIDED|95.0|-0.69|0.11|||MMRM|||Insomnia - Early, Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.11|-0.69|0.1591
72427539|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.31|STANDARD_ERROR_OF_MEAN|0.21||0.1402|TWO_SIDED|95.0|-0.73|0.1|||MMRM|||Insomnia - Early, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.10|-0.73|0.1402
72427540|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.51|STANDARD_ERROR_OF_MEAN|0.205||0.0143|TWO_SIDED|95.0|-0.91|-0.1|||MMRM|||Insomnia - Early, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.10|-0.91|0.0143
72427541|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.25|STANDARD_ERROR_OF_MEAN|0.204||0.2293|TWO_SIDED|95.0|-0.65|0.16|||MMRM|||Insomnia - Early, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.16|-0.65|0.2293
72427542|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.34|STANDARD_ERROR_OF_MEAN|0.2||0.0884|TWO_SIDED|95.0|-0.74|0.05|||MMRM|||Insomnia - Early, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.05|-0.74|0.0884
72427543|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.39|STANDARD_ERROR_OF_MEAN|0.207||0.0622|TWO_SIDED|95.0|-0.8|0.02|||MMRM|||Insomnia - Early, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.02|-0.80|0.0622
72427544|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.34|STANDARD_ERROR_OF_MEAN|0.202||0.0955|TWO_SIDED|95.0|-0.74|0.06|||MMRM|||Insomnia - Early, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.06|-0.74|0.0955
72336551|NCT02752958|144196456|OTHER||Mean Difference (Final Values)|1.74|||<|0.0001|TWO_SIDED|95.0|1.333|2.145|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 Vs Week 12||2.145|1.333|<.0001
72336552|NCT02752958|144196457|OTHER||Mean Difference (Final Values)|1.96|||<|0.0001|TWO_SIDED|95.0|1.545|2.371|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 Vs Week 16||2.371|1.545|<.0001
72336553|NCT02752958|144196458|OTHER||Mean Difference (Final Values)|2.06|||<|0.0001|TWO_SIDED|95.0|1.643|2.469|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 Vs. Week 20||2.469|1.643|<.0001
72336554|NCT02752958|144196459|OTHER||Mean Difference (Final Values)|2.21|||<|0.0001|TWO_SIDED|95.0|1.794|2.62||From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|ANOVA||Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 Vs Week 24||2.620|1.794|<.0001
72427545|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.51|STANDARD_ERROR_OF_MEAN|0.21||0.0173|TWO_SIDED|95.0|-0.92|-0.09|||MMRM|||Insomnia - Early, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.09|-0.92|0.0173
72427546|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.29|STANDARD_ERROR_OF_MEAN|0.206||0.1687|TWO_SIDED|95.0|-0.69|0.12|||MMRM|||Insomnia - Early, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.12|-0.69|0.1687
72336555|NCT02752958|144196460|OTHER||Mean Difference (Final Values)|1.18|||<|0.0001|TWO_SIDED|95.0|0.703|1.66|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 Vs Week 4||1.660|0.703|<0.0001
72336556|NCT02752958|144196461|OTHER||Mean Difference (Final Values)|1.45|||<|0.0001|TWO_SIDED|95.0|0.977|1.926|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 Vs Week 8||1.926|0.977|<.0001
72336557|NCT02752958|144196462|OTHER||Mean Difference (Final Values)|1.95|||<|0.0001|TWO_SIDED|95.0|1.473|2.418|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|"Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice.~Week 0 = Baseline Value"|Week 0 Vs Week 12||2.418|1.473|<.0001
72336558|NCT02752958|144196463|OTHER||Mean Difference (Final Values)|2.33|||<|0.0001|TWO_SIDED|95.0|1.848|2.81|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 Vs Week16||2.810|1.848|<.0001
72336559|NCT02752958|144196464|OTHER||Mean Difference (Final Values)|2.21|||<|0.0001|TWO_SIDED|95.0|1.732|2.694|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 Vs. Week 20||2.694|1.732|<.0001
72336560|NCT02752958|144196465|OTHER||Mean Difference (Final Values)|2.5|||<|0.0001|TWO_SIDED|95.0|2.02|2.982|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 Vs Week 24||2.982|2.020|<.0001
72336561|NCT02752958|144196466|OTHER||Mean Difference (Final Values)|0.43||||0.0786|TWO_SIDED|95.0|-0.05|0.919|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 vs Week 4||0.919|-0.050|0.0786
72427547|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.22|STANDARD_ERROR_OF_MEAN|0.258||0.3861|TWO_SIDED|95.0|-0.74|0.29|||Wilcoxon (Mann-Whitney)|||Insomnia - Early, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.29|-0.74|0.3861
72427548|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.09|STANDARD_ERROR_OF_MEAN|0.249||0.706|TWO_SIDED|95.0|-0.59|0.4|||MMRM|||Insomnia - Early, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.40|-0.59|0.7060
72427549|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.59|STANDARD_ERROR_OF_MEAN|0.23||0.0112|TWO_SIDED|95.0|-1.05|-0.14|||MMRM|||Insomnia - Early, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.14|-1.05|0.0112
72427550|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.42|STANDARD_ERROR_OF_MEAN|0.219||0.057|TWO_SIDED|95.0|-0.86|0.01|||MMRM|||Insomnia - Early, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.01|-0.86|0.0570
72427551|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.67|STANDARD_ERROR_OF_MEAN|0.208||0.0018|TWO_SIDED|95.0|-1.08|-0.26|||MMRM|||Insomnia - Early, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.26|-1.08|0.0018
72427552|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.42|STANDARD_ERROR_OF_MEAN|0.205||0.0443|TWO_SIDED|95.0|-0.83|-0.01|||MMRM|||Insomnia - Early, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.01|-0.83|0.0443
72427553|NCT02942004|144367030|SUPERIORITY||LS mean difference|0.16|STANDARD_ERROR_OF_MEAN|0.104||0.1197|TWO_SIDED|95.0|-0.04|0.37|||MMRM|||Insomnia - Middle, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.37|-0.04|0.1197
72427554|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.04|STANDARD_ERROR_OF_MEAN|0.101||0.7171|TWO_SIDED|95.0|-0.24|0.16|||MMRM|||Insomnia - Middle, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.16|-0.24|0.7171
72336562|NCT02752958|144196467|OTHER||Mean Difference (Final Values)|0.69||||0.005|TWO_SIDED|95.0|0.21|1.171|||ANOVA|\[1\] From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 vs Week 8||1.171|0.210|0.0050
72427555|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.05|STANDARD_ERROR_OF_MEAN|0.138||0.7151|TWO_SIDED|95.0|-0.32|0.22|||MMRM|||Insomnia - Middle, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.22|-0.32|0.7151
72427556|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.09|STANDARD_ERROR_OF_MEAN|0.134||0.521|TWO_SIDED|95.0|-0.35|0.18|||MMRM|||Insomnia - Middle, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.18|-0.35|0.5210
72427557|NCT02942004|144367030|SUPERIORITY||LS mean difference|0.05|STANDARD_ERROR_OF_MEAN|0.142||0.7332|TWO_SIDED|95.0|-0.23|0.33|||MMRM|||Insomnia - Middle, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.33|-0.23|0.7332
72427558|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.11|STANDARD_ERROR_OF_MEAN|0.139||0.4163|TWO_SIDED|95.0|-0.39|0.16|||MMRM|||Insomnia - Middle, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.16|-0.39|0.4163
72427559|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.02|STANDARD_ERROR_OF_MEAN|0.132||0.8625|TWO_SIDED|95.0|-0.28|0.24|||MMRM|||Insomnia - Middle, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.24|-0.28|0.8625
72427560|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.06|STANDARD_ERROR_OF_MEAN|0.128||0.6196|TWO_SIDED|95.0|-0.32|0.19|||MMRM|||Insomnia - Middle, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.19|-0.32|0.6196
72427561|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.41|STANDARD_ERROR_OF_MEAN|0.197||0.0373|TWO_SIDED|95.0|-0.8|-0.02|||MMRM|||Insomnia - Middle, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.02|-0.80|0.0373
72427562|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.36|STANDARD_ERROR_OF_MEAN|0.191||0.0644|TWO_SIDED|95.0|-0.74|0.02|||MMRM|||Insomnia - Middle, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.02|-0.74|0.0644
72427563|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.29|STANDARD_ERROR_OF_MEAN|0.191||0.1347|TWO_SIDED|95.0|-0.66|0.09|||MMRM|||Insomnia - Middle, Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.09|-0.66|0.1347
72427564|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.28|STANDARD_ERROR_OF_MEAN|0.185||0.1269|TWO_SIDED|95.0|-0.65|0.08|||MMRM|||Insomnia - Middle, Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.08|-0.65|0.1269
72427565|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.27|STANDARD_ERROR_OF_MEAN|0.192||0.165|TWO_SIDED|95.0|-0.65|0.11|||MMRM|||Insomnia - Middle, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.11|-0.65|0.1650
72427566|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.29|STANDARD_ERROR_OF_MEAN|0.188||0.1291|TWO_SIDED|95.0|-0.66|0.08|||MMRM|||Insomnia - Middle, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.08|-0.66|0.1291
72427567|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.39|STANDARD_ERROR_OF_MEAN|0.189||0.0402|TWO_SIDED|95.0|-0.77|-0.02|||MMRM|||Insomnia - Middle, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.02|-0.77|0.0402
72427568|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.185||0.0342|TWO_SIDED|95.0|-0.76|-0.03|||MMRM|||Insomnia - Middle, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.03|-0.76|0.0342
72427569|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.193||0.1269|TWO_SIDED|95.0|-0.68|0.09|||MMRM|||Insomnia - Middle, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.09|-0.68|0.1269
72427570|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.16|STANDARD_ERROR_OF_MEAN|0.188||0.3945|TWO_SIDED|95.0|-0.53|0.21|||MMRM|||Insomnia - Middle, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.21|-0.53|0.3945
72427571|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.185||0.5828|TWO_SIDED|95.0|-0.47|0.26|||MMRM|||Insomnia - Middle, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.26|-0.47|0.5828
72427572|NCT02942004|144367030|SUPERIORITY||LS mean difference|0.08|STANDARD_ERROR_OF_MEAN|0.182||0.6625|TWO_SIDED|95.0|-0.28|0.44|||MMRM|||Insomnia - Middle, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.44|-0.28|0.6625
72427573|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.64|STANDARD_ERROR_OF_MEAN|0.216||0.0041|TWO_SIDED|95.0|-1.07|-0.21|||MMRM|||Insomnia - Middle, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.21|-1.07|0.0041
72427574|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.26|STANDARD_ERROR_OF_MEAN|0.21||0.2222|TWO_SIDED|95.0|-0.67|0.16|||MMRM|||Insomnia - Middle, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.16|-0.67|0.2222
72427575|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.218||0.0245|TWO_SIDED|95.0|-0.93|-0.07|||MMRM|||Insomnia - Middle, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.07|-0.93|0.0245
72427576|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.14|STANDARD_ERROR_OF_MEAN|0.209||0.5119|TWO_SIDED|95.0|-0.55|0.28|||MMRM|||Insomnia - Middle, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.28|-0.55|0.5119
72427577|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.43|STANDARD_ERROR_OF_MEAN|0.197||0.0299|TWO_SIDED|95.0|-0.82|-0.04|||MMRM|||Insomnia - Middle, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.04|-0.82|0.0299
72336563|NCT02752958|144196468|OTHER||Mean Difference (Final Values)|1.4|||<|0.0001|TWO_SIDED|95.0|0.918|1.875|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 vs Week 12||1.875|0.918|<.0001
72427578|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.21|STANDARD_ERROR_OF_MEAN|0.195||0.2824|TWO_SIDED|95.0|-0.6|0.18|||MMRM|||Insomnia - Middle, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.18|-0.60|0.2824
72427579|NCT02942004|144367030|SUPERIORITY||LS mean difference|0.18|STANDARD_ERROR_OF_MEAN|0.129||0.1768|TWO_SIDED|95.0|-0.08|0.43|||MMRM|||Insomnia - Late, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.43|-0.08|0.1768
72427580|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.06|STANDARD_ERROR_OF_MEAN|0.126||0.6498|TWO_SIDED|95.0|-0.31|0.19|||MMRM|||Insomnia - Late, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.19|-0.31|0.6498
72336564|NCT02752958|144196469|OTHER||Mean Difference (Final Values)|1.44|||<|0.0001|TWO_SIDED|95.0|0.951|1.926|||ANOVA|\[From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|||1.926|0.951|<.0001
72336565|NCT02752958|144196470|OTHER||Mean Difference (Final Values)|1.17|||<|0.0001|TWO_SIDED|95.0|0.678|1.653||From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|ANOVA||Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 vs Week 20||1.653|0.678|<.0001
72336566|NCT02752958|144196471|OTHER||Mean Difference (Final Values)|1.56|||<|0.0001|TWO_SIDED|95.0|1.072|2.047|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|||2.047|1.072|<.0001
72336567|NCT00977938|144196497|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.71|||<|0.001|TWO_SIDED|95.0|0.59|0.85||P-value was stratified according to geographic region (NA, EU, or AU and NZ), thienopyridine received at the time of randomization, and presence or absence of risk factors for ST; P-value was adjudsted using the Benjamini Hochberg approach.|Log Rank||30-month DAPT vs. 12-month DAPT; HR was stratified according to geographic region (NA, EU, or AU and NZ), thienopyridine drug received at the time of randomization, and presence or absence of risk factors for stent thrombosis.|The primary efficacy analysis was a superiority analysis. We controlled the two-sided family-wise error rate of 0.05 across the two coprimary end points using the Hochberg-Benjamini method. With this method, the null hypothesis of randomized treatment equivalence is rejected if significance is achieved for both end points at a two-sided alpha level of 0.05 or for one end point at a two-sided alpha level of 0.025.||0.85|0.59|<0.001
72336568|NCT00977938|144196498|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.29|||<|0.001|TWO_SIDED|95.0|0.17|0.48||P-value was stratified according to geographic region (NA, EU, or AU and NZ), thienopyridine received at the time of randomization, and presence or absence of risk factors for ST; P-value was adjudsted using the Benjamini Hochberg approach.|Log Rank||30-month DAPT vs. 12-month DAPT; HR was stratified according to geographic region (NA, EU, or AU and NZ), thienopyridine drug received at the time of randomization, and presence or absence of risk factors for stent thrombosis.|The primary efficacy analysis was a superiority analysis. We controlled the two-sided family-wise error rate of 0.05 across the two coprimary end points using the Hochberg-Benjamini method. With this method, the null hypothesis of randomized treatment equivalence is rejected if significance is achieved for both end points at a two-sided alpha level of 0.05 or for one end point at a two-sided alpha level of 0.025.||0.48|0.17|<0.001
72336569|NCT00977938|144196499|NON_INFERIORITY_OR_EQUIVALENCE|The primary safety analysis was a noninferiority analysis performed with the use of the Farrington-Manning risk-difference approach. Assuming an annualized rate for moderate or severe bleeding of 1.9% and an absolute noninferiority margin of 0.8%, at a one-sided alpha level of significance of 0.025, we calculated that a sample size of 9960 patients would give the study 80% power to detect noninferiority.|Risk Difference (RD)|0.96||||0.704|TWO_SIDED|95.0|0.38|1.53||One-sided P-value for non-inferiority|Farrington-Manning||30-month DAPT vs. 12-month DAPT|||1.53|0.38|0.704
72427581|NCT02942004|144367030|SUPERIORITY||LS mean difference|0.04|STANDARD_ERROR_OF_MEAN|0.15||0.7689|TWO_SIDED|95.0|-0.25|0.34|||MMRM|||Insomnia - Late, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.34|-0.25|0.7689
72427582|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.18|STANDARD_ERROR_OF_MEAN|0.146||0.2236|TWO_SIDED|95.0|-0.47|0.11|||MMRM|||Insomnia - Late, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.11|-0.47|0.2236
72427583|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.06|STANDARD_ERROR_OF_MEAN|0.148||0.6952|TWO_SIDED|95.0|-0.35|0.23|||MMRM|||Insomnia - Late, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.23|-0.35|0.6952
72427584|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.23|STANDARD_ERROR_OF_MEAN|0.144||0.1184|TWO_SIDED|95.0|-0.51|0.06|||MMRM|||Insomnia - Late, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.06|-0.51|0.1184
72427585|NCT02942004|144367030|SUPERIORITY||LS mean difference|0.15|STANDARD_ERROR_OF_MEAN|0.149||0.3031|TWO_SIDED|95.0|-0.14|0.45|||MMRM|||Insomnia - Late, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.45|-0.14|0.3031
72427586|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.15|STANDARD_ERROR_OF_MEAN|0.145||0.3091|TWO_SIDED|95.0|-0.44|0.14|||MMRM|||Insomnia - Late, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.14|-0.44|0.3091
72427587|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.26|STANDARD_ERROR_OF_MEAN|0.179||0.1525|TWO_SIDED|95.0|-0.61|0.1|||MMRM|||Insomnia - Late, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.10|-0.61|0.1525
72427588|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.27|STANDARD_ERROR_OF_MEAN|0.174||0.1214|TWO_SIDED|95.0|-0.62|0.07|||MMRM|||Insomnia - Late, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.07|-0.62|0.1214
72427589|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.16|STANDARD_ERROR_OF_MEAN|0.187||0.3811|TWO_SIDED|95.0|-0.53|0.21|||MMRM|||Insomnia - Late, Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.21|-0.53|0.3811
72427590|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.16|STANDARD_ERROR_OF_MEAN|0.18||0.3851|TWO_SIDED|95.0|-0.51|0.2|||MMRM|||Insomnia - Late, Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.20|-0.51|0.3851
72336570|NCT00977938|144196500|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin of 2.28% (0.0228)|Risk Difference (RD)|-1.82|||<|0.001|ONE_SIDED|97.5||0.03||One-sided P-value for non-inferiority|Nam and Kwon|P-value was computed for clustered matched pairs based on Nam and Kwon (2009).|Weighted RD and 1-sided 97.5% upper CL were computed for clustered matched pairs based on Nam and Kwon (2009).|The null hypothesis was that DAPT patients treated with DES would have MACCE rate between 0 and 33 months post-index procedure that exceeds that of the control arm (patients treated with BMS) by at least a pre-specified absolute margin of δ.||0.03||<0.001
72427591|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.27|STANDARD_ERROR_OF_MEAN|0.182||0.1373|TWO_SIDED|95.0|-0.63|0.09|||MMRM|||Insomnia - Late, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.09|-0.63|0.1373
72427592|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.27|STANDARD_ERROR_OF_MEAN|0.177||0.136|TWO_SIDED|95.0|-0.62|0.09|||MMRM|||Insomnia - Late, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.09|-0.62|0.1360
72427593|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.27|STANDARD_ERROR_OF_MEAN|0.176||0.1264|TWO_SIDED|95.0|-0.62|0.08|||MMRM|||Insomnia - Late, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.08|-0.62|0.1264
72427594|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.33|STANDARD_ERROR_OF_MEAN|0.172||0.0567|TWO_SIDED|95.0|-0.67|0.01|||MMRM|||Insomnia - Late, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.01|-0.67|0.0567
72427595|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.06|STANDARD_ERROR_OF_MEAN|0.176||0.7447|TWO_SIDED|95.0|-0.41|0.29|||MMRM|||Insomnia - Late, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.29|-0.41|0.7447
72427596|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.05|STANDARD_ERROR_OF_MEAN|0.172||0.7727|TWO_SIDED|95.0|-0.39|0.29|||MMRM|||Insomnia - Late, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.29|-0.39|0.7727
72427597|NCT02942004|144367030|SUPERIORITY||LS mean difference|0.08|STANDARD_ERROR_OF_MEAN|0.183||0.659|TWO_SIDED|95.0|-0.28|0.44|||MMRM|||Insomnia - Late, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.44|-0.28|0.6590
72427598|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.15|STANDARD_ERROR_OF_MEAN|0.18||0.3951|TWO_SIDED|95.0|-0.51|0.2|||MMRM|||Insomnia - Late, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.20|-0.51|0.3951
72427599|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.17|STANDARD_ERROR_OF_MEAN|0.23||0.4576|TWO_SIDED|95.0|-0.63|0.28|||MMRM|||Insomnia - Late, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.28|-0.63|0.4576
72427600|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.07|STANDARD_ERROR_OF_MEAN|0.223||0.7609|TWO_SIDED|95.0|-0.51|0.37|||MMRM|||Insomnia - Late, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.37|-0.51|0.7609
72427601|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.12|STANDARD_ERROR_OF_MEAN|0.234||0.622|TWO_SIDED|95.0|-0.58|0.35|||MMRM|||Insomnia - Late, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.35|-0.58|0.6220
72427602|NCT02942004|144367030|SUPERIORITY||LS mean difference|0.03|STANDARD_ERROR_OF_MEAN|0.225||0.9081|TWO_SIDED|95.0|-0.42|0.47|||MMRM|||Insomnia - Late, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.47|-0.42|0.9081
72427603|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.27|STANDARD_ERROR_OF_MEAN|0.191||0.1668|TWO_SIDED|95.0|-0.65|0.11|||MMRM|||Insomnia - Late, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.11|-0.65|0.1668
72336571|NCT00977938|144196501|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin of 0.97% (0.0097)|Risk Difference (RD)|-1.05|||<|0.001|ONE_SIDED|97.5||-0.27||One-sided P-value for non-inferiority|Nam and Kwon|P-value was computed for clustered matched pairs based on Nam and Kwon (2009).|Weighted RD and 1-sided 95% upper CL were computed for clustered matched pairs based on Nam and Kwon (2009).|The null hypothesis was that DAPT patients treated with DES would have stent thrombosis rate between 0 and 33 months post-index procedure that exceeds that of the control arm (patients treated with BMS) by at least a pre-specified absolute margin of δ.||-0.27||<0.001
72336572|NCT00977938|144196502|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.82|||||TWO_SIDED|95.0|0.7|0.97|||||30-month DAPT vs. 12-month DAPT; HR was stratified according to geographic region (NA, EU, or AU and NZ), thienopyridine drug received at the time of randomization, and presence or absence of risk factors for stent thrombosis|||0.97|0.70|
72336573|NCT00977938|144196503|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.45|||||TWO_SIDED|95.0|0.29|0.69|||||30-month DAPT vs. 12-month DAPT; HR was stratified according to geographic region (NA, EU, or AU and NZ), thienopyridine drug received at the time of randomization, and presence or absence of risk factors for stent thrombosis|||0.69|0.29|
72336574|NCT00977938|144196504|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.86|||||TWO_SIDED|95.0|0.24|1.48|||||30-month DAPT vs. 12-month DAPT|||1.48|0.24|
72336575|NCT00977938|144196505|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.92||||0.722|TWO_SIDED|95.0|0.57|1.47||This analysis was not powered. P-value was stratified according to geographic region, thienopyridine received at the time of randomization, and presence or absence of risk factors for ST; P-value was adjudsted using the Benjamini Hochberg approach.|Log Rank||30-month DAPT vs. 12-month DAPT; HR was stratified according to geographic region (NA, EU, or AU and NZ), thienopyridine drug received at the time of randomization, and presence or absence of risk factors for stent thrombosis.|This analysis was not powered.||1.47|0.57|0.722
72336576|NCT00977938|144196506|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.49||||0.478|TWO_SIDED|95.0|0.15|1.64||This analysis was not powered. P-value was stratified according to geographic region, thienopyridine received at the time of randomization, and presence or absence of risk factors for ST; P-value was adjudsted using the Benjamini Hochberg approach.|Log Rank||30-month DAPT vs. 12-month DAPT; HR was stratified according to geographic region (NA, EU, or AU and NZ), thienopyridine drug received at the time of randomization, and presence or absence of risk factors for stent thrombosis.|This analysis was not powered.||1.64|0.15|0.478
72336577|NCT00977938|144196507|SUPERIORITY_OR_OTHER||Risk Difference (RD)|1.12||||0.706|TWO_SIDED|95.0|-0.06|2.31|||Farrington-Manning|No formal hypothesis testing was done.|30-month DAPT vs. 12-month DAPT|||2.31|-0.06|0.706
72336578|NCT00977938|144196508|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.91|||||TWO_SIDED|95.0|0.58|1.4|||||30-month DAPT vs. 12-month DAPT; HR was stratified according to geographic region (NA, EU, or AU and NZ), thienopyridine drug received at the time of randomization, and presence or absence of risk factors for stent thrombosis|||1.40|0.58|
72336579|NCT00977938|144196509|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.49|||||TWO_SIDED|95.0|0.15|1.64|||||30-month DAPT vs. 12-month DAPT; HR was stratified according to geographic region (NA, EU, or AU and NZ), thienopyridine drug received at the time of randomization, and presence or absence of risk factors for stent thrombosis.|||1.64|0.15|
72336580|NCT00977938|144196510|SUPERIORITY_OR_OTHER||Risk Difference (RD)|1.03|||||TWO_SIDED|95.0|-0.21|2.28|||||30-month DAPT vs. 12-month DAPT|||2.28|-0.21|
72336581|NCT03373890|144196511|OTHER|Independent samples Mann Whitney U||||||0.39|||||||Wilcoxon (Mann-Whitney)|||||||.39
72336582|NCT03373890|144196512|OTHER|Independent samples Mann Whitney U||||||0.39|||||||Wilcoxon (Mann-Whitney)|||||||.39
72336583|NCT03373890|144196513|OTHER|Independent samples Mann Whitney U||||||0.03|||||||Wilcoxon (Mann-Whitney)|||||||.03
72336584|NCT03373890|144196514|OTHER|Independent samples Mann Whitney U||||||0.39|||||||Wilcoxon (Mann-Whitney)|||||||.39
72336585|NCT03373890|144196515|OTHER|Independent samples Mann Whitney U||||||0.06|||||||Wilcoxon (Mann-Whitney)|||||||.06
72336586|NCT03373890|144196516|OTHER|Independent samples Mann Whitney U||||||0.99|||||||Wilcoxon (Mann-Whitney)|||||||.99
72336587|NCT03373890|144196517|OTHER|LInear mixed model||||||0.008|||||||Regression, Logistic|||||||.008
72336588|NCT03373890|144196518|OTHER|Linear mixed model regression||||||0.34|||||||Regression, Linear|||||||.34
72336589|NCT00884039|144196638|SUPERIORITY_OR_OTHER|||||||0.57|||||||Fisher Exact|||||||0.57
72336590|NCT02182440|144196641|SUPERIORITY||Difference in LS means|-16.53|STANDARD_ERROR_OF_MEAN|19.243||0.949|TWO_SIDED|95.0|-62.57|29.5|||ANOVA|||Analysis for Part 1||29.50|-62.57|0.949
72336591|NCT02182440|144196641|SUPERIORITY||Difference in LS means|-4.65|STANDARD_ERROR_OF_MEAN|9.305||0.691|TWO_SIDED|95.0|-23.09|13.8|||ANOVA|||Analysis for Part 2||13.80|-23.09|0.691
72336592|NCT02182440|144196641|SUPERIORITY||Combined p-value|0.896||||0.896|TWO_SIDED||||||Inverse normal method||The p-values from Part 1 (see Statistical Analysis 1) and Part 2 (see Statistical Analysis 2) were combined to an overall p-value using the inverse normal method.|Combination of analysis results from Part 1 (see statistical Analysis 1) and Part 2 (see Statistical analysis 2)||||0.896
72336593|NCT02182440|144196642|SUPERIORITY||Odds Ratio (OR)|1.4||||0.28|TWO_SIDED|95.0|0.8|2.4|||Chi-squared|||||2.4|0.8|0.28
72336594|NCT02182440|144196643|SUPERIORITY||Mean Difference (Net)|0.12||||0.02|TWO_SIDED|95.0|0.02|0.23|||Cochran-Mantel-Haenszel|||||0.23|0.02|0.02
72336595|NCT02182440|144196644|SUPERIORITY||Mean Difference (Net)|0.12||||0.03|TWO_SIDED|95.0|0.01|0.23|||Cochran-Mantel-Haenszel|||||0.23|0.01|0.03
72427604|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.32|STANDARD_ERROR_OF_MEAN|0.189||0.0935|TWO_SIDED|95.0|-0.69|0.05|||MMRM|||Insomnia - Late, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.05|-0.69|0.0935
72427605|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.13|STANDARD_ERROR_OF_MEAN|0.15||0.4038|TWO_SIDED|95.0|-0.42|0.17|||MMRM|||Work and Activities, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.17|-0.42|0.4038
72336596|NCT02182440|144196645|SUPERIORITY||Hazard Ratio (HR)|1.77||||0.045|TWO_SIDED|95.0|1.0|3.1|||Regression, Logistic|||||3.1|1.0|0.045
72336597|NCT02182440|144196646|SUPERIORITY||Hazard Ratio (HR)|1.85||||0.03|TWO_SIDED|95.0|1.06|3.26|||Regression, Logistic|||||3.26|1.06|0.03
72336598|NCT00072293|144196647|NON_INFERIORITY_OR_EQUIVALENCE|As originally designed, target accrual was 1960 patients with analysis planned after 558 events. These targets were based on having 90% power to detect non-inferiority of no axillary dissection with a one-sided statistical signifi cance level of 10% (ie, α=0·10) under the assumption that 5-year disease-free survival with axillary dissection was 70% and defining non-inferiority as a hazard ratio (HR) of less than 1·25 (no axillary dissection relative to axillary dissection).|Hazard Ratio (HR)|0.78||||0.004|TWO_SIDED|95.0|0.55|1.11||Test for non-inferiority of no axillary dissection. Stratified logrank test compared groups. HR (no-AD vs AD) estimated from test statistic and variance as HR=exp(\[O-E\]/V), compared to 1.25 in 1-sided test of non-inferiority.|1-sided non-inferiority test||Hazard Ratio is no axillary dissection/axillary dissection.|||1.11|0.55|0.004
72336599|NCT00072293|144196648|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.89||||0.73|TWO_SIDED|90.0|0.52|1.54|||Log Rank||Hazard Ratio is no axillary dissection/axillary dissection.|||1.54|0.52|0.73
72336600|NCT00355342|144196693|EQUIVALENCE|The null hypothesis for the primary measure is that the difference between the effects of fluticasone propionate/salmeterol combination product 250/50mcg BID and salmeterol 50mcg BID on the change in BMD assessed at the L1-L4 region of the spine is greater than 1 %/year.|Mean Difference (Final Values)|0.8|STANDARD_ERROR_OF_MEAN|0.36|||TWO_SIDED|95.0|0.06|1.49|||||Analysis Model: Percent change from baseline BMD = treatment + time (years) + treatment\*time + baseline BMD + sex + investigator + age + BMI + FEV1 severity + b/l activity level + b/l calcium supp. use + smoking status.|The analysis is presented for slope estimate calculated for the percent change from Baseline values at Week 26, 52, 78, 104, 130, and 156.|Age split by category (40-64 years old, 65 or older). FEV1 severity based on GOLD Stage (Mild/Moderate, Severe/Very Severe). Activity based on 0-10 Physical Activity Scale (split by median, \<7, \>=7). Slope estimates based on treatment\*time via repeated measures model with unstructured covariance.|1.49|0.06|
72336601|NCT00355342|144196694|EQUIVALENCE|The null hypothesis for the primary measure is that the difference between the effects of fluticasone propionate/salmeterol combination product 250/50mcg BID and salmeterol 50mcg BID on the change in BMD assessed at the L1-L4 region of the spine is greater than 1 %/year.|Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.26|||TWO_SIDED|95.0|-0.78|0.24|||||Analysis Model: Percent change from baseline BMD = treatment + time (years) + treatment\*time + baseline BMD + sex + investigator + age + BMI + FEV1 severity + b/l activity level + b/l calcium supp. use + smoking status|The analysis is presented for slope estimate calculated for the percent change from Baseline values at Week 26, 52, 78, 104, 130, and 156.|Age split by category (40-64 years old, 65 or older). FEV1 severity based on GOLD Stage (Mild/Moderate, Severe/Very Severe). Activity based on 0-10 Physical Activity Scale (split by median, \<7, \>=7). Slope estimates based on treatment\*time via repeated measures model with unstructured covariance.|0.24|-0.78|
72336602|NCT01444027|144196695|SUPERIORITY|||||||0.002||||||Bonferroni adjusted p-value for 3 pairwise comparisons|Regression, Linear|Adjusted for baseline value of the measure, hospice agency, and bereaved status||||||0.002
72336603|NCT01444027|144196695|SUPERIORITY|||||||0.9||||||Bonferroni adjusted p-value for 3 pairwise comparisons.|Regression, Linear|||||||0.90
72336604|NCT01444027|144196695|SUPERIORITY|||||||0.002||||||Bonferroni adjusted p-value for 3 pairwise comparisons.|Regression, Linear|Adjusted for baseline value of the measure, hospice agency, and bereaved status.||||||0.002
72336605|NCT01444027|144196696|SUPERIORITY|||||||0.001||||||Bonferroni adjusted p-value for 3 pairwise comparisons.|Regression, Linear|Adjusted for the baseline value of the measure, hospice agency, and bereaved status.||||||0.001
72336606|NCT01444027|144196696|SUPERIORITY|||||||0.48||||||Bonferroni adjusted p-value for 3 pairwise comparisons.|Regression, Linear|Adjusted for baseline value of the measure, hospice agency, and bereaved status.||||||0.48
72336607|NCT01444027|144196696|SUPERIORITY|||||||0.01||||||Bonferroni adjusted p-value for 3 pairwise comparisons.|Regression, Linear|Adjusted for baseline value of the measure, hospice agency, and bereaved status.||||||.01
72336608|NCT01444027|144196697|SUPERIORITY|||||||0.001||||||Bonferroni adjusted p-value for 3 pairwise comparisons.|Regression, Linear|Adjusted for baseline value of the measure, hospice agency, and bereaved status.||||||0.001
72336609|NCT01444027|144196697|SUPERIORITY|||||||0.83|||||||Regression, Linear|Adjusted for baseline value of the measure, hospice agency, and bereaved status.||||||0.83
72336610|NCT01444027|144196697|SUPERIORITY|||||||0.001||||||Bonferroni adjusted p-value for 3 pairwise comparisons.|Regression, Linear|Adjusted for baseline value of the measure, hospice agency, and bereaved status.||||||0.001
72336611|NCT01444027|144196698|SUPERIORITY|||||||0.003||||||Bonferroni adjusted p-value for 3 pairwise comparisons.|Regression, Linear|Adjusted for baseline value of the measure, hospice agency, and bereaved status.||||||0.003
72336612|NCT01444027|144196698|SUPERIORITY|||||||0.16||||||Bonferroni adjusted p-value for 3 pairwise comparisons.|Regression, Linear|Adjusted for baseline value of the measure, hospice agency, and bereaved status.||||||0.16
72336613|NCT01444027|144196698|SUPERIORITY|||||||0.17||||||Bonferroni adjusted p-value for 3 pairwise comparisons.|Regression, Linear|Adjusted for baseline value of the measure, hospice agency, and bereaved status.||||||0.17
72336614|NCT01444027|144196699|SUPERIORITY|||||||0.001||||||Bonferroni adjusted p-value for 3 pairwise comparisons.|Regression, Linear|Adjusted for baseline value of the measure, hospice agency, and bereaved status.||||||0.001
72336615|NCT01444027|144196699|SUPERIORITY|||||||0.78||||||Bonferroni adjusted p-value for 3 pairwise comparisons.|Regression, Linear|Adjusted for baseline value of the measure, hospice agency, and bereaved status.||||||0.78
72336616|NCT01444027|144196699|SUPERIORITY|||||||0.004||||||Bonferroni adjusted p-value for 3 pairwise comparisons.|Regression, Linear|Adjusted for baseline value of the measure, hospice agency, and bereaved status.||||||0.004
72336617|NCT00953680|144196743|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Equivalence Bounds of (0.80, 1.25).|Least-Squares Mean Ratio|0.993||||||90.0|0.95|1.039||||||Least-Squares Mean Ratio (A/B); A= Single dose losartan 100 mg-HCTZ 12.5 mg combination tablet; B= Single dose losartan 100 mg tablet + HCTZ 12.5 mg capsule||1.039|0.950|
72336618|NCT00953680|144196744|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Equivalence Bounds of (0.80, 1.25).|Least-Squares Mean Ratio|0.835||||||90.0|0.749|0.931||||||Least-Squares Mean Ratio (A/B); A= Single dose losartan 100 mg-HCTZ 12.5 mg combination tablet; B= Single dose losartan 100-mg tablet + HCTZ 12.5 mg capsule||0.931|0.749|
72336619|NCT00953680|144196745|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Equivalence Bounds of (0.80, 1.25).|Least-Squares Mean Ratio|0.924||||||90.0|0.825|1.035||||||Least-Squares Mean Ratio (A/B); A= Single dose losartan 100 mg-HCTZ 12.5 mg combination tablet; B= Single dose losartan 100 mg tablet + HCTZ 12.5 mg capsule||1.035|0.825|
72336620|NCT00953680|144196746|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Equivalence Bounds of (0.80, 1.25).|Least-Squares Mean Ratio|0.931||||||90.0|0.836|1.037||||||Least-Squares Mean Ratio (A/B); A= Single dose losartan 100 mg-HCTZ 12.5 mg combination tablet; B= Single dose losartan 100 mg tablet + HCTZ 12.5 mg capsule||1.037|0.836|
72336621|NCT00737711|144196766|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Paired t-test was used to estimation of p-value.|t-test, 2 sided|||||||<0.0001
72427606|NCT02942004|144367030|SUPERIORITY||LS mean difference|0.05|STANDARD_ERROR_OF_MEAN|0.145||0.7559|TWO_SIDED|95.0|-0.24|0.33|||MMRM|||Work and Activities, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.33|-0.24|0.7559
72427607|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.23|STANDARD_ERROR_OF_MEAN|0.181||0.2006|TWO_SIDED|95.0|-0.59|0.13|||MMRM|||Work and Activities, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.13|-0.59|0.2006
72427608|NCT02942004|144367030|SUPERIORITY||LS mean difference|0.08|STANDARD_ERROR_OF_MEAN|0.175||0.6334|TWO_SIDED|95.0|-0.26|0.43|||MMRM|||Work and Activities, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.43|-0.26|0.6334
72427609|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.14|STANDARD_ERROR_OF_MEAN|0.23||0.5431|TWO_SIDED|95.0|-0.6|0.32|||MMRM|||Work and Activities, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.32|-0.60|0.5431
72427610|NCT02942004|144367030|SUPERIORITY||LS mean difference|0.14|STANDARD_ERROR_OF_MEAN|0.225||0.5278|TWO_SIDED|95.0|-0.3|0.59|||MMRM|||Work and Activities, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.59|-0.30|0.5278
72427611|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.18|STANDARD_ERROR_OF_MEAN|0.232||0.4312|TWO_SIDED|95.0|-0.64|0.28|||MMRM|||Work and Activities, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.28|-0.64|0.4312
72427612|NCT02942004|144367030|SUPERIORITY||LS mean difference|0.19|STANDARD_ERROR_OF_MEAN|0.225||0.3947|TWO_SIDED|95.0|-0.25|0.64|||MMRM|||Work and Activities, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.64|-0.25|0.3947
72427613|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.13|STANDARD_ERROR_OF_MEAN|0.244||0.6081|TWO_SIDED|95.0|-0.61|0.36|||MMRM|||Work and Activities, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.36|-0.61|0.6081
72427614|NCT02942004|144367030|SUPERIORITY||LS mean difference|0.03|STANDARD_ERROR_OF_MEAN|0.238||0.8949|TWO_SIDED|95.0|-0.44|0.5|||MMRM|||Work and Activities, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.50|-0.44|0.8949
72427615|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.38|STANDARD_ERROR_OF_MEAN|0.236||0.112|TWO_SIDED|95.0|-0.84|0.09|||MMRM|||Work and Activities, Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.09|-0.84|0.1120
72427616|NCT02942004|144367030|SUPERIORITY||LS mean difference|0.3|STANDARD_ERROR_OF_MEAN|0.228||0.1842|TWO_SIDED|95.0|-0.15|0.76|||MMRM|||Work and Activities, Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.76|-0.15|0.1842
72427617|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.29|STANDARD_ERROR_OF_MEAN|0.26||0.2646|TWO_SIDED|95.0|-0.81|0.22|||MMRM|||Work and Activities, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.22|-0.81|0.2646
72336622|NCT02124512|144196842|SUPERIORITY||||||>|0.05||||||The p-value was calculated to be \>0.05.|ANOVA|||Comparison of the pre- and post-treatment timecourse between untreated and rifaximin-treated participants.||||>0.05
72336623|NCT02124512|144196843|SUPERIORITY|||||||0.12||||||unpaired Student's t-test|t-test, 2 sided|||Treatment difference (change in placebo pre- and post-treatment versus change in rifaximin pre- and post-treatment).||||0.12
72336624|NCT01431014|144196845|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|95.0|||||t-test, 2 sided|||||||>0.05
72336625|NCT00090233|144196898|NON_INFERIORITY_OR_EQUIVALENCE|Relative Risk ≤10.0 (non-inferiority margin).|relative risk|1.6||||0.006||95.0|0.4|6.4||"p≤ 10/11, where p is proportion of participants with intussusception in vaccine group relative to total number of participants with intussusception. Based on conditional binomial approach.~Adjusted for group-sequential design."|Exact binomial test|Exact binomial test adjusted for group-sequential design.||||6.4|0.4|0.006
72336626|NCT00090233|144196899|SUPERIORITY_OR_OTHER||Proportion|81.2|||<|0.001||95.0|72.9|87.8||p≥42%, where p is proportion of participants with ≥3-fold rise in antibody titer from Predose 1 to Postdose 3 in vaccine group. Based on binomial approach.|Exact binomial test|||||87.8|72.9|<0.001
72336627|NCT00090233|144196900|SUPERIORITY_OR_OTHER||Efficacy=1-Relative Risk|74.0|||<|0.001||95.0|66.8|79.9||"Efficacy≥35%. Based on p≤.65/(.65+k), where p is proportion of participants with outcome in vaccine group relative to total number of participants with outcome, k is ratio of follow-up time; placebo/vaccine.~Based on conditional binomial approach."|Exact binomial test|Exact binomial test.|Efficacy = 1-RR, expressed as a percentage; the RR is the incidence in the vaccine group / the incidence in the placebo group.|||79.9|66.8|<0.001
72336628|NCT00090233|144196901|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|94.5|||<|0.001||95.0|91.2|96.6||Rate Reduction\>0%|Poisson regression|"Poisson regression with generalized estimating equations.~Validated with Van Elteren's extension of Wilcoxon Rank Sum test."|Risk ratio of rate of hospitalizations and emergency department visits between treatment groups. Reported here are results after 12 additional emergency department visits were identified among placebo recipients and data were re-analyzed.|||96.6|91.2|<0.001
72336629|NCT00090233|144196902|SUPERIORITY_OR_OTHER||Efficacy=1-Relative Risk|81.5|||<|0.001||95.0|74.9|86.7||Efficacy\>0%. Based on p\< 1/(1+k), where p is proportion of participants with outcome in vaccine group relative to total number of participants with outcome, and k is ratio of follow-up time; placebo / vaccine. Based on conditional binomial approach.|Exact binomial test||Estimated value is based on the worst episode scores.|||86.7|74.9|<0.001
72427618|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.06|STANDARD_ERROR_OF_MEAN|0.253||0.8101|TWO_SIDED|95.0|-0.56|0.44|||MMRM|||Work and Activities, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.44|-0.56|0.8101
72336630|NCT00090233|144196903|SUPERIORITY_OR_OTHER||Efficacy=1-Relative Risk|98.0|||<|0.001||95.0|88.3|100.0||Efficacy\>0%. Based on p\< 1/(1+k), where p is proportion of participants with outcome in vaccine group relative to total number of participants with outcome, and k is ratio of follow-up time; placebo/vaccine. Based on conditional binomial approach.|Exact binomial test|||||100|88.3|<0.001
72336631|NCT00090233|144196904|NON_INFERIORITY_OR_EQUIVALENCE|Difference (vaccine-placebo) in seroprotection rates was greater than -.10 (non-inferiority margin).|||||<|0.001||95.0||||p\<0.001 was obtained for all comparisons. pv - pp ≥-.10, where p is proportion of participants who achieved seroprotection in the vaccine and placebo groups, respectively.|Miettenen and Nurminen|||||||<0.001
72336632|NCT00090233|144196905|NON_INFERIORITY_OR_EQUIVALENCE|GMTR was greater than 0.5 (non-inferiority margin).|GMTR for Pertussis PT|0.9|||<|0.001|TWO_SIDED|95.0|0.7|1.1|||t-test, 1 sided|t-test on natural log of titers||The GMT Ratio between RotaTeq™ and Placebo (GMTR) for Pertussis PT was used for analysis.||1.1|0.7|<0.001
72336633|NCT00090233|144196905|NON_INFERIORITY_OR_EQUIVALENCE|GMTR was greater than 0.5 (non-inferiority margin).|GMTR for Pertussis FHA|0.9|||<|0.001|TWO_SIDED|95.0|0.7|1.1|||t-test, 1 sided|t-test on natural log of titers||The GMT Ratio between RotaTeq™ and Placebo (GMTR) for Pertussis FHA was used for analysis.||1.1|0.7|<0.001
72336634|NCT00090233|144196905|NON_INFERIORITY_OR_EQUIVALENCE|GMTR was greater than 0.5 (non-inferiority margin).|GMTR for Pertussis Pertactin|0.6||||0.193|TWO_SIDED|95.0|0.4|0.8|||t-test, 1 sided|t-test on natural log of titers||The GMT Ratio between RotaTeq™ and Placebo (GMTR) for Pertussis Pertactin was used for analysis.||0.8|0.4|0.193
72336635|NCT00090233|144196906|NON_INFERIORITY_OR_EQUIVALENCE|GMTR was greater than 0.5 (non-inferiority margin).|GMTR for pneumococcal serotype 4|1.2|||<|0.001||95.0|1.0|1.4|||t-test, 1 sided|t-test on natural log of titers||The GMT Ratio between RotaTeq™ and Placebo (GMTR) for pneumococcal serotype 4 was used for analysis.||1.4|1.0|<0.001
72336636|NCT00090233|144196906|NON_INFERIORITY_OR_EQUIVALENCE|GMTR was greater than 0.5 (non-inferiority margin).|GMTR for pneumococcal serotype 6B|1.4|||<|0.001|TWO_SIDED|95.0|1.0|1.9|||t-test, 1 sided|t-test on natural log of titers||The GMT Ratio between RotaTeq™ and Placebo (GMTR) for pneumococcal serotype 6B was used for analysis.||1.9|1.0|<0.001
72336637|NCT00090233|144196906|NON_INFERIORITY_OR_EQUIVALENCE|GMTR was greater than 0.5 (non-inferiority margin).|GMTR for pneumococcal serotype 9V|1.1|||<|0.001|TWO_SIDED|95.0|0.9|1.3|||t-test, 1 sided|t-test on natural log of titers||The GMT Ratio between RotaTeq™ and Placebo (GMTR) for pneumococcal serotype 9V was used for analysis.||1.3|0.9|<0.001
72336638|NCT00090233|144196906|NON_INFERIORITY_OR_EQUIVALENCE|GMTR was greater than 0.5 (non-inferiority margin).|GMTR for pneumococcal serotype 14|1.0|||<|0.001|TWO_SIDED|95.0|0.7|1.3|||t-test, 1 sided|t-test on natural log of titers||The GMT Ratio between RotaTeq™ and Placebo (GMTR) for pneumococcal serotype 14 was used for analysis.||1.3|0.7|<0.001
72336639|NCT00090233|144196906|NON_INFERIORITY_OR_EQUIVALENCE|GMTR was greater than 0.5 (non-inferiority margin).|GMTR for pneumococcal serotype 18C|1.3|||<|0.001|TWO_SIDED|95.0|1.1|1.6|||t-test, 1 sided|t-test on natural log of titers||The GMT Ratio between RotaTeq™ and Placebo (GMTR) for pneumococcal serotype 18C was used for analysis.||1.6|1.1|<0.001
72336640|NCT00090233|144196906|NON_INFERIORITY_OR_EQUIVALENCE|GMTR was greater than 0.5 (non-inferiority margin).|GMTR for pneumococcal serotype 19F|1.1|||<|0.001|TWO_SIDED|95.0|0.8|1.4|||t-test, 1 sided|t-test on natural log of titers||The GMT Ratio between RotaTeq™ and Placebo (GMTR) for pneumococcal serotype 19F was used for analysis.||1.4|0.8|<0.001
72336641|NCT00090233|144196906|NON_INFERIORITY_OR_EQUIVALENCE|GMTR was greater than 0.5 (non-inferiority margin).|GMTR for pneumococcal serotype 23F|1.1|||<|0.001|TWO_SIDED|95.0|0.9|1.5|||t-test, 1 sided|t-test on natural log of titers||The GMT Ratio between RotaTeq™ and Placebo (GMTR) for pneumococcal serotype 23F was used for analysis.||1.5|0.9|<0.001
72336642|NCT01779869|144196908|SUPERIORITY|Accuracy was assessed compared to an imaging reference standard.||||||0.35|||||||Chi-squared|||Significance testing between the diagnostic accuracy of SPECT and PET, and SPECT and MR, and SPECT and PET/MR was performed by using chi square test. A P value \< 0.05 was considered significant.||||0.35
72336643|NCT01459653|144196914|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.884||||0.3038|TWO_SIDED|95.0|0.6989|1.1182|||Chi-squared|||||1.1182|0.6989|0.3038
72336644|NCT01459653|144196915|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.1897||||0.1432|TWO_SIDED|95.0|0.9428|1.5012|||Chi-squared|||||1.5012|0.9428|0.1432
72336645|NCT01459653|144196916|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.8794||||0.6483|TWO_SIDED|95.0|0.5063|1.5276|||Chi-squared|||||1.5276|0.5063|0.6483
72336646|NCT01459653|144196926|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.2989|||<|0.0001|TWO_SIDED|95.0|1.8113|2.9177|||Chi-squared|||||2.9177|1.8113|<0.0001
72336647|NCT01459653|144196927|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.4963|||<|0.0001|TWO_SIDED|95.0|0.373|0.6605|||Chi-squared|||||0.6605|0.3730|<0.0001
72336648|NCT01459653|144196928|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.9451||||0.7509|TWO_SIDED|95.0|0.6671|1.3391|||Chi-squared|||||1.3391|0.6671|0.7509
72336649|NCT01459653|144196929|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.2683||||0.0067|TWO_SIDED|95.0|1.068|1.5061|||Chi-squared|||||1.5061|1.0680|0.0067
72336650|NCT01459653|144196937|SUPERIORITY_OR_OTHER||Slope|1.0628|||<|0.0001|TWO_SIDED|95.0|0.6382|1.4874|||ANOVA|degrees of freedom: 4507||||1.4874|0.6382|<0.0001
72336651|NCT01459653|144196938|SUPERIORITY_OR_OTHER||Slope|-0.2739||||0.0103|TWO_SIDED|95.0|-0.4832|-0.0646|||ANOVA|degrees of freedom: 4507||||-0.0646|-0.4832|0.0103
72336652|NCT01459653|144196939|SUPERIORITY_OR_OTHER||Slope|0.3812|||<|0.0001|TWO_SIDED|95.0|0.233|0.5295|||ANOVA|degrees of freedom: 4495||||0.5295|0.2330|<0.0001
72336653|NCT01459653|144196947|SUPERIORITY_OR_OTHER||Slope|0.1031||||0.0677|TWO_SIDED|95.0|-0.0075|0.2136|||ANOVA|degrees of freedom: 4516||||0.2136|-0.0075|0.0677
72336654|NCT01459653|144196948|SUPERIORITY_OR_OTHER||Slope|0.0018||||0.8968|TWO_SIDED|95.0|-0.0259|0.0295|||ANOVA|degrees of freedom: 4516||||0.0295|-0.0259|0.8968
72336655|NCT01459653|144196949|SUPERIORITY_OR_OTHER||Slope|0.0741|||<|0.0001|TWO_SIDED|95.0|-0.0452|0.1029|||ANOVA|degrees of freedom: 4505||||0.1029|-0.0452|<0.0001
72336656|NCT01459653|144196957|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.735||||0.2698|TWO_SIDED|95.0|0.4255|1.2698|||Chi-squared|||||1.2698|0.4255|0.2698
72336657|NCT01459653|144196958|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Chi-squared|||||||<0.0001
72336658|NCT01459653|144196975|SUPERIORITY_OR_OTHER|||||||0.5977|TWO_SIDED||||||Log Rank|||||||0.5977
72427619|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.58|STANDARD_ERROR_OF_MEAN|0.248||0.0215|TWO_SIDED|95.0|-1.07|-0.09|||MMRM|||Work and Activities, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.09|-1.07|0.0215
72336659|NCT01459653|144196976|SUPERIORITY_OR_OTHER|||||||0.2435|TWO_SIDED||||||Log Rank|||||||0.2435
72336660|NCT01459653|144196977|SUPERIORITY_OR_OTHER|||||||0.763|TWO_SIDED||||||Log Rank|||||||0.7630
72336661|NCT01459653|144196978|SUPERIORITY_OR_OTHER|||||||0.383|TWO_SIDED||||||Log Rank|||||||0.3830
72336662|NCT01459653|144196979|SUPERIORITY_OR_OTHER|||||||0.0002|TWO_SIDED||||||Log Rank|||||||0.0002
72336663|NCT01459653|144196980|SUPERIORITY_OR_OTHER|||||||0.0301|TWO_SIDED||||||Log Rank|||||||0.0301
72336664|NCT01459653|144196981|SUPERIORITY_OR_OTHER||Slope|0.92||||0.0683|TWO_SIDED|95.0|0.84|1.01|||Regression, Logistic|degrees of freedom: 3181||GCSF treatment decision (under vs correct) as predictor for ANC||1.01|0.84|0.0683
72336665|NCT01459653|144196981|SUPERIORITY_OR_OTHER||Slope|0.89||||0.0019|TWO_SIDED|95.0|0.82|0.96|||Regression, Logistic|degrees of freedom: 3181||GCSF decision (Over vs correct) as predictor for ANC||0.96|0.82|0.0019
72336666|NCT01459653|144196981|SUPERIORITY_OR_OTHER||Slope|1.04||||0.4469|TWO_SIDED|95.0|0.94|1.15|||Regression, Logistic|degrees of freedom: 3181||GCSF decision (Under vs over) as predictor for ANC||1.15|0.94|0.4469
72336667|NCT01459653|144196981|SUPERIORITY_OR_OTHER||Slope|1.11||||0.0079|TWO_SIDED|95.0|1.03|1.19|||Regression, Logistic|||Study drug dose (higher vs lower) as predictor for ANC||1.19|1.03|0.0079
72336668|NCT01459653|144196981|SUPERIORITY_OR_OTHER||Slope|0.81||||0.0004|TWO_SIDED|95.0|0.72|0.91|||Regression, Logistic|||Tumor type (hematological vs solid) as predictor for ANC||0.91|0.72|0.0004
72336669|NCT01459653|144196981|SUPERIORITY_OR_OTHER||Slope|0.86|||<|0.0001|TWO_SIDED|95.0|0.8|0.92|||Regression, Logistic|||Patient gender (female vs male) as predictor for ANC||0.92|0.80|<0.0001
72336670|NCT01459653|144196981|SUPERIORITY_OR_OTHER||Slope|1.04||||0.0235|TWO_SIDED|95.0|1.01|1.08|||Regression, Linear|||ECOG (per 1 point) as predictor for ANC||1.08|1.01|0.0235
72336671|NCT01459653|144196981|SUPERIORITY_OR_OTHER||Slope|1.03|||<|0.0001|TWO_SIDED|95.0|1.02|1.05|||Regression, Linear|||Hb (per g/dL) as predictor for ANC||1.05|1.02|<0.0001
72336672|NCT01459653|144196982|SUPERIORITY_OR_OTHER||Intra-class correlation coefficient|0.09||||0.0003|TWO_SIDED||||||ANCOVA||The intra-class correlation coefficient (ICC) was computed to quantify the variability in patient outcome attributable to within-center variability before any patient-level determinants are considered.|ANCOVA model was used taking into account center, patient within center-level and within-patient level (over time). This appendix describes the center-level.||||0.0003
72336673|NCT01459653|144196982|SUPERIORITY_OR_OTHER||Intra-class correlation coefficient|0.41|||<|0.0001|TWO_SIDED||||||ANCOVA|||ANCOVA model was used taking into account center, patient within center-level and within-patient level (over time). This appendix describes the patient within center-level.||||<0.0001
72336674|NCT01459653|144196982|SUPERIORITY_OR_OTHER||Intra-class correlation coefficient|0.5|||<|0.0001|TWO_SIDED||||||ANCOVA|||ANCOVA model was used taking into account center, patient within center-level and within-patient level (over time). This appendix describes the within-patient level.||||<0.0001
72336675|NCT01459653|144196987|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.544||||0.003|TWO_SIDED|95.0|0.365|0.812|||Regression, Logistic|||GIS (1 vs. 0) as cycle-level predictor for CIN grade 4 episode||0.812|0.365|0.003
72427620|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.24|STANDARD_ERROR_OF_MEAN|0.242||0.3226|TWO_SIDED|95.0|-0.72|0.24|||MMRM|||Work and Activities, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.24|-0.72|0.3226
72427621|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.51|STANDARD_ERROR_OF_MEAN|0.238||0.0339|TWO_SIDED|95.0|-0.98|-0.04|||MMRM|||Work and Activities, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.04|-0.98|0.0339
72427622|NCT02942004|144367030|SUPERIORITY||LS mean difference|0.01|STANDARD_ERROR_OF_MEAN|0.232||0.9824|TWO_SIDED|95.0|-0.46|0.47|||MMRM|||Work and Activities, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.47|-0.46|0.9824
72427623|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.43|STANDARD_ERROR_OF_MEAN|0.254||0.095|TWO_SIDED|95.0|-0.93|0.08|||MMRM|||Work and Activities, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.08|-0.93|0.0950
72427624|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.17|STANDARD_ERROR_OF_MEAN|0.249||0.4865|TWO_SIDED|95.0|-0.67|0.32|||MMRM|||Work and Activities, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.32|-0.67|0.4865
72427625|NCT02942004|144367030|SUPERIORITY||LS mean difference|0.01|STANDARD_ERROR_OF_MEAN|0.292||0.9861|TWO_SIDED|95.0|-0.57|0.58|||MMRM|||Work and Activities, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.58|-0.57|0.9861
72427626|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.03|STANDARD_ERROR_OF_MEAN|0.283||0.9266|TWO_SIDED|95.0|-0.59|0.54|||MMRM|||Work and Activities, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.54|-0.59|0.9266
72427627|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.61|STANDARD_ERROR_OF_MEAN|0.285||0.036|TWO_SIDED|95.0|-1.17|-0.04|||MMRM|||Work and Activities, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.04|-1.17|0.0360
72336676|NCT01459653|144196987|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.795|||<|0.001|TWO_SIDED|95.0|3.242|7.092|||Regression, Logistic|||Concomitant antibiotic prophylaxis as cycle-level predictor for CIN grade 4 episode||7.092|3.242|<0.001
72427628|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.52|STANDARD_ERROR_OF_MEAN|0.273||0.0583|TWO_SIDED|95.0|-1.06|0.02|||MMRM|||Work and Activities, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.02|-1.06|0.0583
72427629|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.53|STANDARD_ERROR_OF_MEAN|0.254||0.0404|TWO_SIDED|95.0|-1.03|-0.02|||MMRM|||Work and Activities, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.02|-1.03|0.0404
72336677|NCT01459653|144196987|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.083|||<|0.001|TWO_SIDED|95.0|3.242|7.092|||Regression, Logistic|||CIN1/4 in previous cycle as cycle-level predictor for CIN grade 4 episode||7.092|3.242|<0.001
72336678|NCT01459653|144196987|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.46|||<|0.001|TWO_SIDED|95.0|1.542|3.925|||Regression, Logistic|||History of CIN Grade 4 at enrollment as patient-level predictor for CIN grade 4 episode||3.925|1.542|<0.001
72336679|NCT01459653|144196987|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.452||||0.003|TWO_SIDED|95.0|0.267|0.766|||Regression, Logistic|||Over- vs. correctly prophylacted as patient-level predictor for CIN grade 4 episode||0.766|0.267|0.003
72427630|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.37|STANDARD_ERROR_OF_MEAN|0.249||0.1352|TWO_SIDED|95.0|-0.87|0.12|||MMRM|||Work and Activities, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.12|-0.87|0.1352
72427631|NCT02942004|144367030|SUPERIORITY||LS mean difference|0.34|STANDARD_ERROR_OF_MEAN|0.121||0.0056|TWO_SIDED|95.0|0.1|0.58|||MMRM|||Retardation, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.58|0.10|0.0056
72427632|NCT02942004|144367030|SUPERIORITY||LS mean difference|0.17|STANDARD_ERROR_OF_MEAN|0.118||0.1537|TWO_SIDED|95.0|-0.06|0.4|||MMRM|||Retardation, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.40|-0.06|0.1537
72427633|NCT02942004|144367030|SUPERIORITY||LS mean difference|0.32|STANDARD_ERROR_OF_MEAN|0.129||0.0142|TWO_SIDED|95.0|0.07|0.58|||MMRM|||Retardation, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.58|0.07|0.0142
72427634|NCT02942004|144367030|SUPERIORITY||LS mean difference|0.31|STANDARD_ERROR_OF_MEAN|0.126||0.0159|TWO_SIDED|95.0|0.06|0.56|||MMRM|||Retardation, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.56|0.06|0.0159
72427635|NCT02942004|144367030|SUPERIORITY||LS mean difference|0.16|STANDARD_ERROR_OF_MEAN|0.132||0.2255|TWO_SIDED|95.0|-0.1|0.42|||MMRM|||Retardation, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.42|-0.10|0.2255
72427636|NCT02942004|144367030|SUPERIORITY||LS mean difference|0.21|STANDARD_ERROR_OF_MEAN|0.129||0.1069|TWO_SIDED|95.0|-0.05|0.46|||MMRM|||Retardation, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.46|-0.05|0.1069
72427637|NCT02942004|144367030|SUPERIORITY||LS mean difference|0.1|STANDARD_ERROR_OF_MEAN|0.144||0.4932|TWO_SIDED|95.0|-0.19|0.39|||MMRM|||Retardation, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.39|-0.19|0.4932
72427638|NCT02942004|144367030|SUPERIORITY||LS mean difference|0.16|STANDARD_ERROR_OF_MEAN|0.14||0.2634|TWO_SIDED|95.0|-0.12|0.43|||MMRM|||Retardation, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.43|-0.12|0.2634
72336680|NCT01459653|144196988|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.925||||0.001|TWO_SIDED|95.0|1.592|5.374|||Regression, Logistic|||History of CIN Grade 4 at enrollment as patient-level predictor for CIN grade 4 episode||5.374|1.592|0.001
72336681|NCT01459653|144196988|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.572||||0.005|TWO_SIDED|95.0|1.331|4.969|||Regression, Logistic|||Concomitant antibiotic prophylaxis as patient-level predictor for CIN grade 4 episode||4.969|1.331|0.005
72427639|NCT02942004|144367030|SUPERIORITY||LS mean difference|0.01|STANDARD_ERROR_OF_MEAN|0.133||0.9284|TWO_SIDED|95.0|-0.25|0.28|||MMRM|||Retardation, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.28|-0.25|0.9284
72336682|NCT01459653|144196988|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.328|||<|0.001|TWO_SIDED|95.0|0.193|0.557|||Regression, Logistic|||Over- vs. correctly prophylacted as patient-level predictor for CIN grade 4 episode||0.557|0.193|<0.001
72336683|NCT01459653|144196989|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.673|||<|0.001|TWO_SIDED|95.0|1.284|2.179|||Regression, Logistic|||ECOG score (per 1 point) as cycle-level predictor for FN episode||2.179|1.284|<0.001
72336684|NCT01459653|144196989|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.704|||<|0.001|TWO_SIDED|95.0|2.777|7.968|||Regression, Logistic|||Concomitant antibiotic prophylaxis as cycle-level predictor for FN episode||7.968|2.777|<0.001
72336685|NCT01459653|144196989|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.19||||0.002|TWO_SIDED|95.0|1.342|3.574|||Regression, Logistic|||CIN1/4 in previous cycle as cycle-level predictor for FN episode||3.574|1.342|0.002
72336686|NCT01459653|144196989|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.215||||0.01|TWO_SIDED|95.0|0.067|0.687|||Regression, Logistic|||History of anaemia at enrollment as patient-level predictor for FN episode||0.687|0.067|0.010
72336687|NCT01459653|144196989|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.501||||0.025|TWO_SIDED|95.0|1.169|10.487|||Regression, Logistic|||Under- vs. over-prophylacted as patient-level predictor for FN episode||10.487|1.169|0.025
72336688|NCT01459653|144196990|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.975||||0.003|TWO_SIDED|95.0|0.958|0.991|||Regression, Logistic|||Patient age (per 1 year) as patient-level predictor for FN episode||0.991|0.958|0.003
72336689|NCT01459653|144196990|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.398|||<|0.001|TWO_SIDED|95.0|1.61|3.57|||Regression, Logistic|||ECOG ≥2 during study as patient-level predictor for FN episode||3.570|1.610|<0.001
72336690|NCT01459653|144196990|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.562||||0.001|TWO_SIDED|95.0|1.45|4.527|||Regression, Logistic|||Concomitant antibiotic prophylaxis as patient-level predictor for FN episode||4.527|1.450|0.001
72336691|NCT01459653|144196990|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.232|||<|0.001|TWO_SIDED|95.0|0.108|0.499|||Regression, Logistic|||Over- vs. correctly prophylacted as patient-level predictor for FN episode||0.499|0.108|<0.001
72336692|NCT01459653|144196990|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.261||||0.011|TWO_SIDED|95.0|1.315|8.084|||Regression, Logistic|||Under- vs. over-prophylacted as patient-level predictor for FN episode||8.084|1.315|0.011
72336693|NCT01459653|144196991|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.814|||<|0.001|TWO_SIDED|95.0|1.397|2.355|||Regression, Logistic|||ECOG score (per 1 point) as cycle-level predictor for CIN/FN-related hospitalization||2.355|1.397|<0.001
72336694|NCT01459653|144196991|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.296|||<|0.001|TWO_SIDED|95.0|1.791|6.065|||Regression, Logistic|||Concomitant antibiotic prophylaxis as cycle-level predictor for CIN/FN-related hospitalization||6.065|1.791|<0.001
72336695|NCT01459653|144196991|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.205||||0.001|TWO_SIDED|95.0|1.38|3.524|||Regression, Logistic|||CIN1/4 in previous cycles as cycle-level predictor for CIN/FN-related hospitalization||3.524|1.380|0.001
72336696|NCT01459653|144196991|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.863||||0.032|TWO_SIDED|95.0|1.054|3.293|||Regression, Logistic|||Under- vs. correctly prophylacted as patient-level predictor for CIN/FN-related hospitalization||3.293|1.054|0.032
72336697|NCT01459653|144196991|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.385||||0.024|TWO_SIDED|95.0|0.168|0.879|||Regression, Logistic|||Over- vs. correctly prophylacted as patient-level predictor for CIN/FN-related hospitalization||0.879|0.168|0.024
72336698|NCT01459653|144196991|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.843||||0.001|TWO_SIDED|95.0|1.964|11.942|||Regression, Logistic|||Under- vs. over-prophylacted as patient-level predictor for CIN/FN-related hospitalization||11.942|1.964|0.001
72336699|NCT01459653|144196992|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.473|||<|0.001|TWO_SIDED|95.0|1.55|3.946|||Regression, Logistic|||ECOG ≥2 during study as patient-level predictor for CIN/FN-related hospitalization||3.946|1.550|<0.001
72336700|NCT01459653|144196992|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.382||||0.002|TWO_SIDED|95.0|0.21|0.695|||Regression, Logistic|||Over- vs. correctly prophylacted as patient-level predictor for CIN/FN-related hospitalization||0.695|0.210|0.002
72336701|NCT01459653|144196992|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.108||||0.001|TWO_SIDED|95.0|1.56|6.192|||Regression, Logistic|||Under- vs. over-prophylacted as patient-level predictor for CIN/FN-related hospitalization||6.192|1.560|0.001
72336702|NCT01459653|144196993|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|8.931|||<|0.001|TWO_SIDED|95.0|5.426|14.699|||Regression, Logistic|||CIN1/4 in previous cycle as cycle-level predictor for CIN/FN-related chemotherapy disturbance||14.699|5.426|<0.001
72336703|NCT01459653|144196993|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.336||||0.007|TWO_SIDED|95.0|0.152|0.74|||Regression, Logistic|||Hematological cancer (vs. oncologic) as patient-level predictor for CIN/FN-related chemotherapy disturbance||0.740|0.152|0.007
72336704|NCT01459653|144196993|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.999||||0.006|TWO_SIDED|95.0|0.999|1.0|||Regression, Logistic|||Cancer patients seen in 2009 (per 1 patient) as center-level predictor for CIN/FN-related chemotherapy disturbance||1.000|0.999|0.006
72336705|NCT01459653|144196993|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.001|||<|0.001|TWO_SIDED|95.0|1.0|1.001|||Regression, Logistic|||Chemotherapy-treated cancer patients in 2009 (per 1 patient) as center-level predictor for CIN/FN-related chemotherapy disturbance||1.001|1.000|<0.001
72336706|NCT01459653|144196993|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.456||||0.024|TWO_SIDED|95.0|1.127|5.353|||Regression, Logistic|||Center type: academic vs non-academic as center-level predictor for CIN/FN-related chemotherapy disturbance||5.353|1.127|0.024
72336707|NCT01459653|144196993|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.344||||0.01|TWO_SIDED|95.0|1.342|8.331|||Regression, Logistic|||Center type: academic-affiliated vs non-academic as center-level predictor for CIN/FN-related chemotherapy disturbance||8.331|1.342|0.010
72336708|NCT01459653|144196994|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.965||||0.006|TWO_SIDED|95.0|1.218|3.172|||Regression, Logistic|||Female gender as patient-level predictor for CIN/FN-related chemotherapy disturbance||3.172|1.218|0.006
72336709|NCT01459653|144196994|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.594||||0.001|TWO_SIDED|95.0|1.469|4.581|||Regression, Logistic|||History of CIN4 at enrollment as patient-level predictor for CIN/FN-related chemotherapy disturbance||4.581|1.469|0.001
72336710|NCT01459653|144196995|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.59||||0.002|TWO_SIDED|95.0|0.424|0.821|||Regression, Logistic|||GIS (1 vs. 0) as cycle-level predictor for composite outcome (any of CIN Grade 4, FN, CIN/FN-related hospitalization, CIN/FN-related chemotherapy disturbance)||0.821|0.424|0.002
72336711|NCT01459653|144196995|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.644||||0.003|TWO_SIDED|95.0|0.489|0.859|||Regression, Logistic|||Zarzio duration: 4-5 days vs. 6 or more as cycle-level predictor for composite outcome (any of CIN Grade 4, FN, CIN/FN-related hospitalization, CIN/FN-related chemotherapy disturbance)||0.859|0.489|0.003
72336712|NCT01459653|144196995|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.579||||0.004|TWO_SIDED|95.0|0.398|0.842|||Regression, Logistic|||Zarzio duration: 1-3 days vs. 6 or more as cycle-level predictor for composite outcome (any of CIN Grade 4, FN, CIN/FN-related hospitalization, CIN/FN-related chemotherapy disturbance)||0.842|0.398|0.004
72336713|NCT01459653|144196995|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.369||||0.001|TWO_SIDED|95.0|1.14|1.643|||Regression, Logistic|||ECOG score (per 1 point) as cycle-level predictor for composite outcome (any of CIN Grade 4, FN, CIN/FN-related hospitalization, CIN/FN-related chemotherapy disturbance)||1.643|1.140|0.001
72336714|NCT01459653|144196995|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.499|||<|0.001|TWO_SIDED|95.0|2.456|4.985|||Regression, Logistic|||Concomitant antibiotic prophylaxis as cycle-level predictor for composite outcome (any of CIN Grade 4, FN, CIN/FN-related hospitalization, CIN/FN-related chemotherapy disturbance)||4.985|2.456|<0.001
72336715|NCT01459653|144196995|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.064|||<|0.001|TWO_SIDED|95.0|3.096|5.336|||Regression, Logistic|||CIN1/4 in previous cycle as cycle-level predictor for composite outcome (any of CIN Grade 4, FN, CIN/FN-related hospitalization, CIN/FN-related chemotherapy disturbance)||5.336|3.096|<0.001
72336716|NCT01459653|144196995|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.545||||0.002|TWO_SIDED|95.0|1.175|2.033|||Regression, Logistic|||Female gender as patient-level predictor for composite outcome (any of CIN Grade 4, FN, CIN/FN-related hospitalization, CIN/FN-related chemotherapy disturbance)||2.033|1.175|0.002
72336717|NCT01459653|144196995|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.596||||0.017|TWO_SIDED|95.0|1.088|2.34|||Regression, Logistic|||History of CIN Grade 4 at enrollment as patient-level predictor for composite outcome (any of CIN Grade 4, FN, CIN/FN-related hospitalization, CIN/FN-related chemotherapy disturbance)||2.340|1.088|0.017
72336718|NCT01459653|144196996|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.621||||0.006|TWO_SIDED|95.0|1.152|2.281|||Regression, Logistic|||Female gender as patient-level predictor for composite outcome (any of CIN Grade 4, FN, CIN/FN-related hospitalization, CIN/FN-related chemotherapy disturbance)||2.281|1.152|0.006
72336719|NCT01459653|144196996|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.898||||0.005|TWO_SIDED|95.0|1.209|2.979|||Regression, Logistic|||History of CIN4 at enrollment as patient-level predictor for composite outcome (any of CIN Grade 4, FN, CIN/FN-related hospitalization, CIN/FN-related chemotherapy disturbance)||2.979|1.209|0.005
72336720|NCT01459653|144196996|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.68||||0.016|TWO_SIDED|95.0|1.2|5.984|||Regression, Logistic|||History of repeated infections at enrollment as patient-level predictor for composite outcome (any of CIN Grade 4, FN, CIN/FN-related hospitalization, CIN/FN-related chemotherapy disturbance)||5.984|1.200|0.016
72336721|NCT01459653|144196996|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.438|||<|0.001|TWO_SIDED|95.0|0.291|0.66|||Regression, Logistic|||Over- vs. correctly prophylacted as patient-level predictor for composite outcome (any of CIN Grade 4, FN, CIN/FN-related hospitalization, CIN/FN-related chemotherapy disturbance)||0.660|0.291|<0.001
72336722|NCT01459653|144196996|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.053||||0.002|TWO_SIDED|95.0|1.295|3.256|||Regression, Logistic|||Under- vs. over-prophylacted as patient-level predictor for composite outcome (any of CIN Grade 4, FN, CIN/FN-related hospitalization, CIN/FN-related chemotherapy disturbance)||3.256|1.295|0.002
72336723|NCT01459653|144196996|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.558||||0.028|TWO_SIDED|95.0|0.332|0.939|||Regression, Logistic|||GIS at enrollment (1 vs. 0) as patient-level predictor for composite outcome (any of CIN Grade 4, FN, CIN/FN-related hospitalization, CIN/FN-related chemotherapy disturbance)||0.939|0.332|0.028
72336724|NCT01459653|144196997|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.2064||||0.0116|TWO_SIDED|95.0|1.1931|4.0803|||Regression, Logistic|||Patient level predictor: History of anemia at enrollment||4.0803|1.1931|0.0116
72336725|NCT01459653|144196997|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.3049||||0.0057|TWO_SIDED|95.0|1.2754|4.1656|||Regression, Logistic|||Liver/renal/cardiac comorbidity as patient level predictor||4.1656|1.2754|0.0057
72336726|NCT01459653|144196997|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|17.535|||<|0.0001|TWO_SIDED|95.0|8.2159|37.4243|||Regression, Logistic|||Poor performance (ECOG \>=2) during study as patient level predictor||37.4243|8.2159|<0.0001
72336727|NCT01459653|144197001|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|14.8703|||<|0.0001|TWO_SIDED|95.0|5.9567|37.1225|||Regression, Logistic|||Female gender as patient-level predictor for cancer-related mortality||37.1225|5.9567|<0.0001
72336728|NCT01459653|144197001|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|14.8703|||<|0.0001|TWO_SIDED|95.0|5.9567|37.1225|||Regression, Logistic|||Poor performance (ECOG \>=2) during study as patient-level predictor||37.1225|5.9567|<0.0001
72336729|NCT03315104|144197100|SUPERIORITY|A median estimated value of 0.000 indicates no difference between groups.|Median Difference (Net)|0.0||||0.174|TWO_SIDED|95.0|0.0|1.0||No adjustment for multiple comparisons, two-sided significance level of 0.05|Wilcoxon (Mann-Whitney)|Exact test|FLU-IGIV High Dose (450 mL) - Placebo|Pairwise Wilcoxon rank-sum test for a location shift||1.000|0.000|0.174
72336730|NCT03315104|144197100|SUPERIORITY|A median estimated value of 0.000 indicates no difference between groups.|Mean Difference (Net)|0.0||||0.572|TWO_SIDED|95.0|0.0|1.0||No adjustment for multiple comparisons, two-sided significance level of 0.05|Wilcoxon (Mann-Whitney)|Exact test||Pairwise Wilcoxon rank-sum test for a location shift||1.000|0.000|0.572
72336731|NCT03315104|144197100|SUPERIORITY|A median estimated value of 0.000 indicates no difference between groups.|Median Difference (Net)|0.0||||0.534|TWO_SIDED|95.0|0.0|1.0||No adjustment for multiple comparisons. two-sided significance level of 0.05|Wilcoxon (Mann-Whitney)|Exact test||Pairwise Wilcoxon rank-sum test for a location shift||1.000|0.000|0.534
72336732|NCT03315104|144197100|SUPERIORITY|A median estimated value of 0.000 indicates no difference between groups.|Median Difference (Net)|0.0||||0.534|TWO_SIDED|95.0|0.0|1.0||No adjustment for multiple comparisons, two-sided significance level of 0.05|Wilcoxon (Mann-Whitney)|Exact test|FLU-IGIV pooled (450 mL + 250 mL) - Placebo|Pairwise Wilcoxon rank-sum test for a location shift where the two active dose groups were pooled and compared to placebo.||1.000|0.000|0.534
72336733|NCT00027378|144197101|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.39|STANDARD_DEVIATION|0.702||0.05||95.0|||||ANOVA|repeated measures||Repeated measures ANOVA||||.05
72336734|NCT03199053|144197131|SUPERIORITY||Adjusted mean difference|-1.03|STANDARD_ERROR_OF_MEAN|0.274|<|0.001|TWO_SIDED|95.0|-1.57|-0.49|||ANCOVA|||||-0.49|-1.57|< 0.001
72336735|NCT03199053|144197132|SUPERIORITY||Adjusted mean difference|-0.44|STANDARD_ERROR_OF_MEAN|0.251||0.078|TWO_SIDED|95.0|-0.93|0.05|||ANCOVA|||||0.05|-0.93|0.078
72336736|NCT03199053|144197133|SUPERIORITY||Adjusted mean difference|-0.86|STANDARD_ERROR_OF_MEAN|0.3||0.004|TWO_SIDED|95.0|-1.44|-0.27|||ANCOVA|||||-0.27|-1.44|0.004
72336737|NCT03199053|144197134|SUPERIORITY||Adjusted mean difference|-0.51|STANDARD_ERROR_OF_MEAN|0.277||0.067|TWO_SIDED|95.0|-1.05|0.04|||ANCOVA|||||0.04|-1.05|0.067
72427640|NCT02942004|144367030|SUPERIORITY||LS mean difference|0.01|STANDARD_ERROR_OF_MEAN|0.129||0.9459|TWO_SIDED|95.0|-0.25|0.26|||MMRM|||Retardation, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.26|-0.25|0.9459
72427641|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.16|STANDARD_ERROR_OF_MEAN|0.151||0.2908|TWO_SIDED|95.0|-0.46|0.14|||MMRM|||Retardation, Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.14|-0.46|0.2908
72427642|NCT02942004|144367030|SUPERIORITY||LS mean difference|0.06|STANDARD_ERROR_OF_MEAN|0.146||0.6834|TWO_SIDED|95.0|-0.23|0.35|||MMRM|||Retardation, Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.35|-0.23|0.6834
72427643|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.13|STANDARD_ERROR_OF_MEAN|0.142||0.3579|TWO_SIDED|95.0|-0.41|0.15|||MMRM|||Retardation, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.15|-0.41|0.3579
72427644|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.03|STANDARD_ERROR_OF_MEAN|0.138||0.827|TWO_SIDED|95.0|-0.3|0.24|||MMRM|||Retardation, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.24|-0.30|0.8270
72427645|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.08|STANDARD_ERROR_OF_MEAN|0.13||0.5292|TWO_SIDED|95.0|-0.34|0.18|||MMRM|||Retardation, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.18|-0.34|0.5292
72427646|NCT02942004|144367030|SUPERIORITY||LS mean difference|0.02|STANDARD_ERROR_OF_MEAN|0.127||0.879|TWO_SIDED|95.0|-0.23|0.27|||MMRM|||Retardation, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.27|-0.23|0.8790
72427647|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.133||0.1347|TWO_SIDED|95.0|-0.46|0.06|||MMRM|||Retardation, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.06|-0.46|0.1347
72427648|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.14|STANDARD_ERROR_OF_MEAN|0.129||0.2874|TWO_SIDED|95.0|-0.4|0.12|||MMRM|||Retardation, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.12|-0.40|0.2874
72427649|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.35|STANDARD_ERROR_OF_MEAN|0.132||0.0086|TWO_SIDED|95.0|-0.61|-0.09|||MMRM|||Retardation, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.09|-0.61|0.0086
72427650|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.03|STANDARD_ERROR_OF_MEAN|0.129||0.7864|TWO_SIDED|95.0|-0.29|0.22|||MMRM|||Retardation, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.22|-0.29|0.7864
72427651|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.13|STANDARD_ERROR_OF_MEAN|0.172||0.4383|TWO_SIDED|95.0|-0.48|0.21|||MMRM|||Retardation, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.21|-0.48|0.4383
72336738|NCT03199053|144197135|SUPERIORITY||Adjusted mean difference|-1.19|STANDARD_ERROR_OF_MEAN|0.29|<|0.001|TWO_SIDED|95.0|-1.76|-0.62|||ANCOVA|||||-0.62|-1.76|< 0.001
72336739|NCT03199053|144197136|SUPERIORITY||Adjusted mean difference|-0.39|STANDARD_ERROR_OF_MEAN|0.27||0.146|TWO_SIDED|95.0|-0.92|0.14|||ANCOVA|||||0.14|-0.92|0.146
72336740|NCT03199053|144197137|SUPERIORITY||Adjusted mean difference|-1.08|STANDARD_ERROR_OF_MEAN|0.479||0.024|TWO_SIDED|95.0|-2.02|-0.14|||ANCOVA|||||-0.14|-2.02|0.024
72336741|NCT03199053|144197138|SUPERIORITY||Adjusted mean difference|-0.11|STANDARD_ERROR_OF_MEAN|0.528||0.833|TWO_SIDED|95.0|-1.15|0.92|||ANCOVA|||||0.92|-1.15|0.833
72336742|NCT03199053|144197139|SUPERIORITY||Adjusted mean difference|-1.04|STANDARD_ERROR_OF_MEAN|0.525||0.047|TWO_SIDED|95.0|-2.07|-0.01|||ANCOVA|||||-0.01|-2.07|0.047
72336743|NCT03199053|144197140|SUPERIORITY||Adjusted mean difference|-0.54|STANDARD_ERROR_OF_MEAN|0.49||0.268|TWO_SIDED|95.0|-1.5|0.42|||ANCOVA|||||0.42|-1.50|0.268
72336744|NCT03199053|144197141|SUPERIORITY||Adjusted mean difference|-1.12|STANDARD_ERROR_OF_MEAN|0.505||0.026|TWO_SIDED|95.0|-2.11|-0.13|||ANCOVA|||||-0.13|-2.11|0.026
72336745|NCT03199053|144197142|SUPERIORITY||Adjusted mean difference|0.29|STANDARD_ERROR_OF_MEAN|0.618||0.644|TWO_SIDED|95.0|-0.92|1.5|||ANCOVA|||||1.50|-0.92|0.644
72336746|NCT03199053|144197143|SUPERIORITY||Adjusted Odds Ratio|3.8||||0.019|TWO_SIDED|95.0|1.2|11.7|||Regression, Logistic|||||11.7|1.2|0.019
72336747|NCT03199053|144197143|SUPERIORITY||Adjusted Odds Ratio|2.6||||0.114|TWO_SIDED|95.0|0.8|8.6|||Regression, Logistic|||||8.6|0.8|0.114
72336748|NCT03199053|144197144|SUPERIORITY||Adjusted Odds Ratio|3.5||||0.042|TWO_SIDED|95.0|1.0|11.4|||Weighted Logistic Regression|||||11.4|1.0|0.042
72336749|NCT03199053|144197144|SUPERIORITY||Adjusted Odds Ratio|2.3||||0.175|TWO_SIDED|95.0|0.7|7.4|||Weighted Logistic Regression|||||7.4|0.7|0.175
72336750|NCT03199053|144197145|SUPERIORITY||Adjusted Odds Ratio|4.4||||0.009|TWO_SIDED|95.0|1.4|13.2|||Weighted Logistic Regression|||||13.2|1.4|0.009
72336751|NCT03199053|144197145|SUPERIORITY||Adjusted Odds Ratio|3.8||||0.042|TWO_SIDED|95.0|1.1|13.5|||Weighted Logistic Regression|||||13.5|1.1|0.042
72336752|NCT03199053|144197146|SUPERIORITY||Adjusted mean difference|-0.03|STANDARD_ERROR_OF_MEAN|0.496||0.955|TWO_SIDED|95.0|-1.0|0.94|||ANCOVA|||||0.94|-1.00|0.955
72336753|NCT03199053|144197146|SUPERIORITY||Adjusted mean difference|-0.23|STANDARD_ERROR_OF_MEAN|0.495||0.64|TWO_SIDED|95.0|-1.2|0.74|||ANCOVA|||||0.74|-1.20|0.640
72336754|NCT03199053|144197147|SUPERIORITY||Adjusted mean difference|-0.64|STANDARD_ERROR_OF_MEAN|0.896||0.476|TWO_SIDED|95.0|-2.39|1.12|||ANCOVA|||||1.12|-2.39|0.476
72336755|NCT03199053|144197147|SUPERIORITY||Adjusted mean difference|-1.81|STANDARD_ERROR_OF_MEAN|1.017||0.075|TWO_SIDED|95.0|-3.81|0.18|||ANCOVA|||||0.18|-3.81|0.075
72336756|NCT03199053|144197148|SUPERIORITY||Unadjusted Difference in Percentage|-19.7||||0.182|TWO_SIDED|95.0|-44.5|5.7|||Fisher Exact|||||5.7|-44.5|0.182
72336757|NCT03199053|144197149|SUPERIORITY||Unadjusted Difference in Percentage|-6.3||||0.65|TWO_SIDED|95.0|-29.8|16.5|||Fisher Exact|||||16.5|-29.8|0.650
72336758|NCT00246025|144197210|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-16.8||||0.0155||95.0|-30.2|-3.4||Multiplicity was not adjusted because of hierarchical testing from highest to lowest dose.|normal approximation method|Statistical inference was made on the basis of the normal approximation of two independent binomial distributions.|The risk differences are calculated as risk in the dabigatran groups minus risk in the placebo group.|Superiority of dabigatran etexilate to placebo was tested by means of hierarchical tests. Statistical inference was made on the basis of the normal approximation of two independent binomial distributions.||-3.4|-30.2|0.0155
72336759|NCT00246025|144197210|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-23.7||||0.0006||95.0|-37.0|-10.5||Multiplicity was not adjusted because of hierarchical testing from highest to lowest dose.|normal approximation method|Statistical inference was made on the basis of the normal approximation of two independent binomial distributions.|The risk differences are calculated as risk in the dabigatran groups minus risk in the placebo group.|Superiority of dabigatran etexilate to placebo was tested by means of hierarchical tests. Statistical inference was made on the basis of the normal approximation of two independent binomial distributions.||-10.5|-37.0|0.0006
72336760|NCT00246025|144197210|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-32.5|||<|0.0001||95.0|-45.4|-19.6||Multiplicity was not adjusted because of hierarchical testing from highest to lowest dose.|normal approximation method|Statistical inference was made on the basis of the normal approximation of two independent binomial distributions.|The risk differences are calculated as risk in the dabigatran groups minus risk in the placebo group.|Superiority of dabigatran etexilate to placebo was tested by means of hierarchical tests. Statistical inference was made on the basis of the normal approximation of two independent binomial distributions.||-19.6|-45.4|<0.0001
72336761|NCT00246025|144197211|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-4.0||||0.1124||95.0|-9.1|1.0||Multiplicity was not adjusted.|normal approximation method|Statistical inference was made on the basis of the normal approximation of two independent binomial distributions.||Superiority of dabigatran etexilate to placebo was tested. Statistical inference was made on the basis of the normal approximation of two independent binomial distributions.||1.0|-9.1|0.1124
72336762|NCT00246025|144197211|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-4.0||||0.1183||95.0|-9.1|1.1||Multiplicity was not adjusted.|normal approximation method|Statistical inference was made on the basis of the normal approximation of two independent binomial distributions.||Superiority of dabigatran etexilate to placebo was tested. Statistical inference was made on the basis of the normal approximation of two independent binomial distributions.||1.1|-9.1|0.1183
72336763|NCT00246025|144197211|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-5.8||||0.0138||95.0|-10.3|-1.3||Multiplicity was not adjusted.|normal approximation method|Statistical inference was made on the basis of the normal approximation of two independent binomial distributions.||Superiority of dabigatran etexilate to placebo was tested. Statistical inference was made on the basis of the normal approximation of two independent binomial distributions.||-1.3|-10.3|0.0138
72336764|NCT00246025|144197212|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-4.0||||0.1124||95.0|-9.1|1.0||Multiplicity was not adjusted.|normal approximation method|Statistical inference was made on the basis of the normal approximation of two independent binomial distributions.||"Superiority of dabigatran etexilate to placebo was tested. Statistical inference was made on the basis of the normal approximation of two independent binomial distributions.~The dabigatran groups were compared to the placebo group.. The null hypotheses are Ho: placebo = 220mg, Ho: placebo = 150mg and Ho: placebo = 110mg. ,All comparisons were two-sided with a significance level of 5%. Confidence intervals were two-sided with a level of 95%."||1.0|-9.1|0.1124
72427652|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.03|STANDARD_ERROR_OF_MEAN|0.167||0.8767|TWO_SIDED|95.0|-0.36|0.31|||MMRM|||Retardation, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.31|-0.36|0.8767
72427653|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.33|STANDARD_ERROR_OF_MEAN|0.153||0.0341|TWO_SIDED|95.0|-0.63|-0.03|||MMRM|||Retardation, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.03|-0.63|0.0341
72427654|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.09|STANDARD_ERROR_OF_MEAN|0.147||0.5629|TWO_SIDED|95.0|-0.38|0.21|||MMRM|||Retardation, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.21|-0.38|0.5629
72336765|NCT00246025|144197212|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-4.0||||0.1183||95.0|-9.1|1.1||Multiplicity was not adjusted.|normal approximation method|Statistical inference was made on the basis of the normal approximation of two independent binomial distributions.||"Superiority of dabigatran etexilate to placebo was tested. Statistical inference was made on the basis of the normal approximation of two independent binomial distributions.~The dabigatran groups were compared to the placebo group.. The null hypotheses are Ho: placebo = 220mg, Ho: placebo = 150mg and Ho: placebo = 110mg. ,All comparisons were two-sided with a significance level of 5%. Confidence intervals were two-sided with a level of 95%."||1.1|-9.1|0.1183
72369724|NCT02930018|144249750|SUPERIORITY|It is hypothesized that the cleavage of nerinetide by plasmin which is activated by tissue plasminogen activators, such as alteplase results in a treatment modification of nerinetide in AIS patients with prior administration of alteplase as part of standard-of-care.|Odds Ratio (OR)|0.776||||0.199|TWO_SIDED|95.0|0.527|1.143||2 sided 0.05 significance level.|Regression, Logistic|||||1.143|0.527|0.199
72369725|NCT02930018|144249751|SUPERIORITY||Odds Ratio (OR)|1.657||||0.028|TWO_SIDED|95.0|1.055|2.603|||Regression, Logistic|||||2.603|1.055|0.028
72369726|NCT02930018|144249751|SUPERIORITY||Absolute Risk Difference (%)|9.6|||||TWO_SIDED||||||||The unadjusted absolute risk difference in % between nerinetide and placebo in the no-alteplase subgroup.|||||
72369727|NCT02930018|144249751|SUPERIORITY||Relative Risk Difference (%)|19.3|||||TWO_SIDED||||||||The unadjusted relative risk difference in % between nerinetide and placebo in the no-alteplase subgroup.|||||
72369728|NCT02930018|144249752|SUPERIORITY||Odds Ratio (OR)|1.482||||0.088|TWO_SIDED|95.0|0.943|2.329|||Regression, Logistic|||||2.329|0.943|0.088
72369729|NCT02930018|144249752|SUPERIORITY||Absolute Risk Difference (%)|9.1|||||TWO_SIDED||||||||The unadjusted absolute risk difference in % between nerinetide and placebo in the no-alteplase subgroup.|||||
72369730|NCT02930018|144249752|SUPERIORITY||Relative Risk Difference (%)|18.3|||||TWO_SIDED||||||||The unadjusted relative risk difference in % between nerinetide and placebo in the no-alteplase subgroup.|||||
72369731|NCT02930018|144249753|SUPERIORITY||Odds Ratio (OR)|0.572||||0.055|TWO_SIDED|95.0|0.323|1.013|||Regression, Logistic|||||1.013|0.323|0.055
72369732|NCT02930018|144249753|SUPERIORITY||Absolute Risk Difference (%)|7.5|||||TWO_SIDED||||||||The unadjusted absolute risk difference in % between nerinetide and placebo in the no-alteplase subgroup.|||||
72369733|NCT02930018|144249753|SUPERIORITY||Relative Risk Difference (%)|39.7|||||TWO_SIDED||||||||The unadjusted relative risk difference in % between nerinetide and placebo in the no-alteplase subgroup.|||||
72369734|NCT02930018|144249754|SUPERIORITY|It is hypothesized that the cleavage of nerinetide by plasmin which is activated by tissue plasminogen activators, such as alteplase results in a treatment modification of nerinetide in AIS patients with prior administration of alteplase as part of standard-of-care.|Odds Ratio (OR)|0.887||||0.529|TWO_SIDED|95.0|0.612|1.286|||Regression, Logistic|||||1.286|0.612|0.529
72369735|NCT02930018|144249755|SUPERIORITY|It is hypothesized that the cleavage of nerinetide by plasmin which is activated by tissue plasminogen activators, such as alteplase results in a treatment modification of nerinetide in AIS patients with prior administration of alteplase as part of standard-of-care.|Odds Ratio (OR)|0.782||||0.181|TWO_SIDED|95.0|0.545|1.121|||Regression, Logistic|||||1.121|0.545|0.181
72369736|NCT02930018|144249756|SUPERIORITY|It is hypothesized that the cleavage of nerinetide by plasmin which is activated by tissue plasminogen activators, such as alteplase results in a treatment modification of nerinetide in AIS patients with prior administration of alteplase as part of standard-of-care.|Odds Ratio (OR)|1.05||||0.869|TWO_SIDED|95.0|0.588|1.874|||Regression, Logistic|||||1.874|0.588|0.869
72369737|NCT04193189|144249795|NON_INFERIORITY|Pre-specified non-inferiority margin (2-CpG minus 3-alum): -10%.|Common proportion difference|12.5|||||TWO_SIDED|97.5|4.1|20.9|||||Common SPR proportion (expressed as percentage of participants) difference (2-CpG minus 3-alum) with two-sided 97.5% Newcombe confidence interval stratified by sex at birth and diabetes status; Mantel-Haenszel weights were used.|Primary objective of Group A||20.9|4.1|
72369738|NCT04193189|144249795|SUPERIORITY||Common proportion difference|18.4|||||TWO_SIDED|97.5|10.4|26.2|||||Common SPR proportion (expressed as percentage of participants) difference (3-CpG minus 3-alum) with two-sided 97.5% Newcombe repeated confidence interval stratified by sex at birth and diabetes status; Mantel-Haenszel weights were used.|Primary objective of Group A||26.2|10.4|
72369739|NCT04193189|144249795|SUPERIORITY||Common proportion difference|6.0|||||TWO_SIDED|97.5|-0.2|11.8|||||Common SPR proportion (expressed as percentage of participants) difference (3-CpG minus 2-CpG) with two-sided 97.5% Newcombe confidence interval stratified by sex at birth and diabetes status; Mantel-Haenszel weights were used.|Secondary objective of Group A||11.8|-0.2|
72369740|NCT04193189|144249797|SUPERIORITY||Common proportion difference|9.0|||||TWO_SIDED|97.5|0.1|18.1|||||Common SPR proportion (expressed as percentage of participants) difference (2-CpG minus 3-alum) with two-sided 97.5% Newcombe confidence interval stratified by sex at birth and diabetes status; Mantel-Haenszel weights were used.|Comparison of Group A 2-CpG and 3-alum at 4 weeks post last scheduled vaccination (Week 8 in 2-CpG, Week 28 in 3-alum)||18.1|0.1|
72336766|NCT00246025|144197212|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-5.8||||0.0138||95.0|-10.3|-1.3||Multiplicity was not adjusted.|normal approximation method|Statistical inference was made on the basis of the normal approximation of two independent binomial distributions.||"Superiority of dabigatran etexilate to placebo was tested. Statistical inference was made on the basis of the normal approximation of two independent binomial distributions.~The dabigatran groups were compared to the placebo group.. The null hypotheses are Ho: placebo = 220mg, Ho: placebo = 150mg and Ho: placebo = 110mg. ,All comparisons were two-sided with a significance level of 5%. Confidence intervals were two-sided with a level of 95%."||-1.3|-10.3|0.0138
72336767|NCT00246025|144197213|SUPERIORITY_OR_OTHER|||||||0.6107||95.0||||Multiplicity was not adjusted.|Fisher Exact|||"Superiority of dabigatran etexilate to placebo was tested based on Fisher's exact test.~The dabigatran groups were compared to the placebo group.. The null hypotheses are Ho: placebo = 220mg, Ho: placebo = 150mg and Ho: placebo = 110mg. ,All comparisons were two-sided with a significance level of 5%. Confidence intervals were two-sided with a level of 95%."||||0.6107
72336768|NCT00246025|144197213|SUPERIORITY_OR_OTHER|||||||1||95.0||||Multiplicity was not adjusted.|Fisher Exact|||"Superiority of dabigatran etexilate to placebo was tested based on Fisher's exact test.~The dabigatran groups were compared to the placebo group.. The null hypotheses are Ho: placebo = 220mg, Ho: placebo = 150mg and Ho: placebo = 110mg. ,All comparisons were two-sided with a significance level of 5%. Confidence intervals were two-sided with a level of 95%."||||1.0000
72336769|NCT00246025|144197213|SUPERIORITY_OR_OTHER|||||||0.6162||95.0||||Multiplicity was not adjusted.|Fisher Exact|||"Superiority of dabigatran etexilate to placebo was tested based on Fisher's exact test.~The dabigatran groups were compared to the placebo group.. The null hypotheses are Ho: placebo = 220mg, Ho: placebo = 150mg and Ho: placebo = 110mg. ,All comparisons were two-sided with a significance level of 5%. Confidence intervals were two-sided with a level of 95%."||||0.6162
72336770|NCT00246025|144197214|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-16.8||||0.0155|TWO_SIDED|95.0|-30.2|-3.4||Multiplicity was not adjusted.|normal approximation method|Statistical inference was made on the basis of the normal approximation of two independent binomial distributions.||"Superiority of dabigatran etexilate to placebo was tested. Statistical inference was made on the basis of the normal approximation of two independent binomial distributions.~The dabigatran groups were compared to the placebo group.. The null hypotheses are Ho: placebo = 220mg, Ho: placebo = 150mg and Ho: placebo = 110mg. ,All comparisons were two-sided with a significance level of 5%. Confidence intervals were two-sided with a level of 95%."||-3.4|-30.2|0.0155
72336771|NCT00246025|144197214|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-23.7||||0.0006|TWO_SIDED|95.0|-37.0|-10.5||Multiplicity was not adjusted.|normal approximation method|Statistical inference was made on the basis of the normal approximation of two independent binomial distributions.||"Superiority of dabigatran etexilate to placebo was tested. Statistical inference was made on the basis of the normal approximation of two independent binomial distributions.~The dabigatran groups were compared to the placebo group.. The null hypotheses are Ho: placebo = 220mg, Ho: placebo = 150mg and Ho: placebo = 110mg. ,All comparisons were two-sided with a significance level of 5%. Confidence intervals were two-sided with a level of 95%."||-10.5|-37.0|0.0006
72336772|NCT00246025|144197214|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-32.5|||<|0.0001|TWO_SIDED|95.0|-45.4|-19.6||Multiplicity was not adjusted.|normal approximation method|Statistical inference was made on the basis of the normal approximation of two independent binomial distributions.||"Superiority of dabigatran etexilate to placebo was tested. Statistical inference was made on the basis of the normal approximation of two independent binomial distributions.~The dabigatran groups were compared to the placebo group.. The null hypotheses are Ho: placebo = 220mg, Ho: placebo = 150mg and Ho: placebo = 110mg. ,All comparisons were two-sided with a significance level of 5%. Confidence intervals were two-sided with a level of 95%."||-19.6|-45.4|<.0001
72336773|NCT00246025|144197217|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|||Comparison versus Placebo for the category major bleeding events||||1.0000
72336774|NCT00246025|144197217|SUPERIORITY_OR_OTHER|||||||0.496||95.0|||||Fisher Exact|||Comparison versus Placebo for the category major bleeding events||||0.4960
72336775|NCT00246025|144197217|SUPERIORITY_OR_OTHER|||||||0.6223||95.0|||||Fisher Exact|||Comparison versus Placebo for the category major bleeding events||||0.6223
72336776|NCT00246025|144197217|SUPERIORITY_OR_OTHER||Absolute Difference (Percentage)|-2.5||||0.1513|TWO_SIDED|95.0|-5.9|1.0|||normal approximation method|Statistical inference was made on the basis of the normal approximation of two independent binomial distributions.||Absolute difference versus Placebo for the category major and clinically relevant bleeding events||1.0|-5.9|0.1513
72336777|NCT00246025|144197217|SUPERIORITY_OR_OTHER||Absolute Difference (Percentage)|-2.4||||0.1696|TWO_SIDED|95.0|-5.9|1.0|||normal approximation method|Statistical inference was made on the basis of the normal approximation of two independent binomial distributions.||Absolute difference versus Placebo for the category major and clinically relevant bleeding events||1.0|-5.9|0.1696
72336778|NCT00246025|144197217|SUPERIORITY_OR_OTHER||Absolute Difference (Percentage)|0.7||||0.7802|TWO_SIDED|95.0|-3.9|5.2|||normal approximation method|Statistical inference was made on the basis of the normal approximation of two independent binomial distributions.||Absolute difference versus Placebo for the category major and clinically relevant bleeding events||5.2|-3.9|0.7802
72336779|NCT00246025|144197217|SUPERIORITY_OR_OTHER||Absolute Difference (Percentage)|1.7||||0.6313|TWO_SIDED|95.0|-5.3|8.7|||normal approximation method|Statistical inference was made on the basis of the normal approximation of two independent binomial distributions.||Absolute difference versus Placebo for the category any bleeding events||8.7|-5.3|0.6313
72336780|NCT00246025|144197217|SUPERIORITY_OR_OTHER||Absolute Difference (Percentage)|2.3||||0.5377|TWO_SIDED|95.0|-4.9|9.4|||normal approximation method|Statistical inference was made on the basis of the normal approximation of two independent binomial distributions.||Absolute difference versus Placebo for the category any bleeding events||9.4|-4.9|0.5377
72336781|NCT00246025|144197217|SUPERIORITY_OR_OTHER||Absolute Difference (Percentage)|2.8||||0.4493|TWO_SIDED|95.0|-4.4|10.0|||normal approximation method|Statistical inference was made on the basis of the normal approximation of two independent binomial distributions.||Absolute difference versus Placebo for the category any bleeding events||10.0|-4.4|0.4493
72336782|NCT02240368|144197268|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||bootstrap|||||||<0.01
72336783|NCT02240368|144197269|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||bootstrap|||||||<0.01
72336784|NCT02240368|144197270|SUPERIORITY_OR_OTHER|||||||0.01|||||||Wilcoxon (Mann-Whitney)|||||||0.01
72336785|NCT02240368|144197271|SUPERIORITY_OR_OTHER||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||||||<0.01
72336786|NCT00909545|144197276|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.04|STANDARD_ERROR_OF_MEAN|2.03||0.9834|TWO_SIDED|95.0|-3.99|4.07||P-values for efficacy outcomes will be one-sided test with alpha = 0.05|ANCOVA|Analysis of covariance is used, with terms representing assigned treatment group and baseline value of the measure in the model.|Least square mean(standard error) and 95% confidence intervals of the difference between Isradipine CR 5mg and placebo groups is estimated.|Change in UPDRS total score of Isradipine CR 5mg/day arm is compared to placebo group.||4.07|-3.99|0.9834
72336787|NCT00909545|144197276|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.1|STANDARD_ERROR_OF_MEAN|1.97||0.5761|TWO_SIDED|95.0|-5.01|2.8||P-values for efficacy outcomes will be one-sided test with alpha = 0.05|ANCOVA|Analysis of covariance is used, with terms representing assigned treatment group and baseline value of the measure in the model.|Least square mean(standard error) and 95% confidence intervals of the difference between Isradipine CR 10mg and placebo groups is estimated.|Change in UPDRS total score of Isradipine CR 10mg/day arm is compared to placebo group.||2.80|-5.01|0.5761
72336788|NCT00909545|144197276|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.0|STANDARD_ERROR_OF_MEAN|2.01||0.322|TWO_SIDED|95.0|-5.98|1.99||P-values for efficacy outcomes will be one-sided test with alpha = 0.05|ANCOVA|Analysis of covariance is used, with terms representing assigned treatment group and baseline value of the measure in the model|Least square mean(standard error) and 95% confidence intervals of the difference between Isradipine CR 20mg and placebo groups is estimated.|Change in UPDRS total score of Isradipine CR 20mg/day arm is compared to placebo group.||1.99|-5.98|0.322
72336789|NCT00909545|144197277|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.19|STANDARD_ERROR_OF_MEAN|1.1587||0.1383|TWO_SIDED|95.0|0.0196|1.8411|||Fisher Exact|||The tolerability of 5mg/day dosage of isradipine CR will be compared with that of the placebo group using one-sided Fisher's exact tests. No adjustment will be made for multiple comparisons in these analyses.||1.8411|0.0196|0.1383
72336790|NCT00909545|144197277|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.1086|STANDARD_ERROR_OF_MEAN|0.1114||0.0248|TWO_SIDED|95.0|0.0123|0.9591|||Fisher Exact|||The tolerability of 10mg/day dosage of isradipine CR will be compared with that of the placebo group using one-sided Fisher's exact tests. No adjustment will be made for multiple comparisons in these analyses.||0.9591|0.0123|0.0248
72336791|NCT00909545|144197277|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.024|STANDARD_ERROR_OF_MEAN|1.1035|<|0.0001|TWO_SIDED|95.0|0.0028|0.2087|||Fisher Exact|||The tolerability of 20mg/day dosage of isradipine CR will be compared with that of the placebo group using one-sided Fisher's exact tests. No adjustment will be made for multiple comparisons in these analyses.||0.2087|0.0028|<0.0001
72336792|NCT00909545|144197278|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.46|STANDARD_ERROR_OF_MEAN|0.38||0.2324|TWO_SIDED|95.0|-0.3|1.22|||ANCOVA|||Change in Mental UPDRS subscale of Isradipine CR 5mg/day arm is compared to placebo group.||1.22|-0.30|0.2324
72336793|NCT00909545|144197278|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|0.37||1|TWO_SIDED|95.0|-0.73|0.73|||ANCOVA|||Change in Mental UPDRS subscale of Isradipine CR 10mg/day arm is compared to placebo group.||0.73|-0.73|1
72427655|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.42|STANDARD_ERROR_OF_MEAN|0.129||0.0016|TWO_SIDED|95.0|-0.67|-0.16|||MMRM|||Retardation, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.16|-0.67|0.0016
72427656|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.25|STANDARD_ERROR_OF_MEAN|0.126||0.0495|TWO_SIDED|95.0|-0.5|0.0|||MMRM|||Retardation, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.00|-0.50|0.0495
72427657|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.06|STANDARD_ERROR_OF_MEAN|0.155||0.7177|TWO_SIDED|95.0|-0.36|0.25|||MMRM|||Agitation, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.25|-0.36|0.7177
72336794|NCT00909545|144197278|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.27|STANDARD_ERROR_OF_MEAN|0.37||0.4675|TWO_SIDED|95.0|-1.02|0.47|||ANCOVA|||Change in Mental UPDRS subscale of Isradipine CR 20mg/day arm is compared to placebo group.||0.47|-1.02|0.4675
72336795|NCT00909545|144197279|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.6|STANDARD_ERROR_OF_MEAN|0.82||0.4648|TWO_SIDED|95.0|-1.03|2.23|||ANCOVA|||Change in ADL UPDRS subscale of Isradipine CR 5mg/day arm is compared to placebo group.||2.23|-1.03|0.4648
72336796|NCT00909545|144197279|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.51|STANDARD_ERROR_OF_MEAN|0.8||0.525|TWO_SIDED|95.0|-2.09|1.07|||ANCOVA|||Change in ADL UPDRS subscale of Isradipine CR 10mg/day arm is compared to placebo group.||1.07|-2.09|0.525
72336797|NCT00909545|144197279|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.74|STANDARD_ERROR_OF_MEAN|0.81||0.3674|TWO_SIDED|95.0|-2.36|0.88|||ANCOVA|||Change in ADL UPDRS subscale of Isradipine CR 20mg/day arm is compared to placebo group.||0.88|-2.36|0.3674
72336798|NCT00909545|144197280|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.83|STANDARD_ERROR_OF_MEAN|1.5||0.579|TWO_SIDED|95.0|-3.8|2.14|||ANCOVA|||Change in Motor UPDRS subscale of Isradipine CR 5mg/day arm is compared to placebo group.||2.14|-3.80|0.579
72336799|NCT00909545|144197280|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.41|STANDARD_ERROR_OF_MEAN|1.46||0.7778|TWO_SIDED|95.0|-3.3|2.48|||ANCOVA|||Change in Motor UPDRS subscale of Isradipine CR 10mg/day arm is compared to placebo group.||2.48|-3.30|0.7778
72336800|NCT00909545|144197280|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.64|STANDARD_ERROR_OF_MEAN|1.48||0.669|TWO_SIDED|95.0|-3.58|2.31|||ANCOVA|||Change in Motor UPDRS subscale of Isradipine CR 20mg/day arm is compared to placebo group.||2.31|-3.58|0.669
72336801|NCT00909545|144197281|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.05|STANDARD_ERROR_OF_MEAN|0.11||0.6677|TWO_SIDED|95.0|-0.27|0.17|||ANCOVA|||Change in Modified Hoehn \& Yahr Scale of Isradipine CR 5mg/day arm is compared to placebo group.||0.17|-0.27|0.6677
72336802|NCT00909545|144197281|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.15|STANDARD_ERROR_OF_MEAN|0.11||0.1755|TWO_SIDED|95.0|-0.36|0.07|||ANCOVA|||Change in Modified Hoehn \& Yahr Scale of Isradipine CR 10mg/day arm is compared to placebo group.||0.07|-0.36|0.1755
72336803|NCT00909545|144197281|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.16|STANDARD_ERROR_OF_MEAN|0.11||0.1463|TWO_SIDED|95.0|-0.38|0.06|||ANCOVA|||Change in Modified Hoehn \& Yahr Scale of Isradipine CR 20mg/day arm is compared to placebo group.||0.06|-0.38|0.1463
72336804|NCT00909545|144197282|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.52|STANDARD_ERROR_OF_MEAN|1.4||0.7111|TWO_SIDED|95.0|-3.3|2.26|||ANCOVA|||Change in Modified Schwab \& England Independence Scale of Isradipine CR 5mg/day arm is compared to placebo group.||2.26|-3.30|0.7111
72336805|NCT00909545|144197282|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.35|STANDARD_ERROR_OF_MEAN|1.36||0.3237|TWO_SIDED|95.0|-1.35|4.04|||ANCOVA|||Change in Modified Schwab \& England Independence Scale of Isradipine CR 10mg/day arm is compared to placebo group.||4.04|-1.35|0.3237
72336806|NCT00909545|144197282|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.27|STANDARD_ERROR_OF_MEAN|1.4||0.3658|TWO_SIDED|95.0|-1.51|4.05|||ANCOVA|||Change in Modified Schwab \& England Independence Scale of Isradipine CR 20mg/day arm is compared to placebo group.||4.05|-1.51|0.3658
72336807|NCT00909545|144197283|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.5|STANDARD_ERROR_OF_MEAN|1.32||0.0608|TWO_SIDED|95.0|-0.12|5.13|||ANCOVA|||Change in BDI-II of Isradipine CR 5mg/day arm is compared to placebo group.||5.13|-0.12|0.0608
72336808|NCT00909545|144197283|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.63|STANDARD_ERROR_OF_MEAN|1.36||0.6445|TWO_SIDED|95.0|-2.07|3.33|||ANCOVA|||Change in BDI-II of Isradipine CR 10mg/day arm is compared to placebo group.||3.33|-2.07|0.6445
72336809|NCT00909545|144197283|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.02|STANDARD_ERROR_OF_MEAN|1.52||0.1336|TWO_SIDED|95.0|-0.63|4.67|||ANCOVA|||Change in BDI-II of Isradipine CR 20mg/day arm is compared to placebo group.||4.67|-0.63|0.1336
72336810|NCT00909545|144197284|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.52|STANDARD_ERROR_OF_MEAN|0.56||0.3533|TWO_SIDED|95.0|-1.64|0.59|||ANCOVA|||Change in Montreal Cognitive Assessment of Isradipine CR 5mg/day arm is compared to placebo group.||0.59|-1.64|0.3533
72336811|NCT00909545|144197284|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.47|STANDARD_ERROR_OF_MEAN|0.56||0.4045|TWO_SIDED|95.0|-1.59|0.65|||ANCOVA|||Change in Montreal Cognitive Assessment of Isradipine CR 10mg/day arm is compared to placebo group.||0.65|-1.59|0.4045
72336812|NCT00909545|144197284|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.22|STANDARD_ERROR_OF_MEAN|0.57||0.7049|TWO_SIDED|95.0|-1.36|0.92|||ANCOVA|||Change in Montreal Cognitive Assessment of Isradipine CR 20mg/day arm is compared to placebo group.||0.92|-1.36|0.7049
72336813|NCT00909545|144197285|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.19|STANDARD_ERROR_OF_MEAN|1.8||0.2278|TWO_SIDED|95.0|-1.4|5.79|||ANCOVA|||Change in PDQ-39 of Isradipine CR 5mg/day arm is compared to placebo group.||5.79|-1.40|0.2278
72336814|NCT00909545|144197285|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.72|STANDARD_ERROR_OF_MEAN|1.86||0.356|TWO_SIDED|95.0|-1.97|5.42|||ANCOVA|||Change in PDQ-39 of Isradipine CR 5mg/day arm is compared to placebo group.||5.42|-1.97|0.356
72336815|NCT00909545|144197285|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.07|STANDARD_ERROR_OF_MEAN|1.83||0.26|TWO_SIDED|95.0|-1.56|5.71|||ANCOVA|||Change in PDQ-39 of Isradipine CR 20mg/day arm is compared to placebo group.||5.71|-1.56|0.2600
72336816|NCT00909545|144197292|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.2632|STANDARD_ERROR_OF_MEAN|1.159||0.1384|TWO_SIDED|95.0|0.5432|50.9977||The analysis of common AE of each active dosage of isradipine CR will be compared with that of the placebo group using one-sided Fisher's exact tests. No adjustment will be made for multiple comparisons in these analyses.|Fisher Exact|||The analyses is to compare Isradipine CR 5mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Oedema Peripheral.||50.9977|0.5432|0.1384
72336817|NCT00909545|144197292|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|15.625|STANDARD_ERROR_OF_MEAN|1.097||0.0024|TWO_SIDED|95.0|1.8214|134.0403||The analysis of common AE of each active dosage of isradipine CR will be compared with that of the placebo group using one-sided Fisher's exact tests. No adjustment will be made for multiple comparisons in these analyses.|Fisher Exact|||Fisher's exact test will be used to compare Isradipine CR 10mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Oedema Peripheral.||134.0403|1.8214|0.0024
72336818|NCT00909545|144197292|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|50.0|STANDARD_ERROR_OF_MEAN|1.108|<|0.0001|TWO_SIDED|95.0|5.7004|438.5694||The analysis of common AE of each active dosage of isradipine CR will be compared with that of the placebo group using one-sided Fisher's exact tests. No adjustment will be made for multiple comparisons in these analyses.|Fisher Exact|||Fisher's exact test will be used to compare Isradipine CR 20mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Oedema Peripheral.||438.5694|5.7004|<.0001
72336819|NCT00909545|144197293|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.754|STANDARD_ERROR_OF_MEAN|0.6715||0.7735|TWO_SIDED|95.0|0.2022|2.812|||Fisher Exact|||one-sided Fisher's exact test will be used to compare Isradipine CR 5mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Dizziness.||2.8120|0.2022|0.7735
72336820|NCT00909545|144197293|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.8143|STANDARD_ERROR_OF_MEAN|0.6419||0.7385|TWO_SIDED|95.0|0.2314|2.8658|||Fisher Exact|||one-sided Fisher's exact test will be used to compare Isradipine CR 10mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Dizziness.||2.8658|0.2314|0.7385
72336821|NCT00909545|144197293|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.9048|STANDARD_ERROR_OF_MEAN|0.6463||0.6823|TWO_SIDED|95.0|0.2549|3.2112|||Fisher Exact|||One-sided Fisher's exact test will be used to compare Isradipine CR 20mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Dizziness.||3.2112|0.2549|0.6823
72336822|NCT00909545|144197294|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.5263|STANDARD_ERROR_OF_MEAN|0.9188||0.2756|TWO_SIDED|95.0|0.4172|15.2975|||Fisher Exact|||One-sided Fisher's exact test will be used to compare Isradipine CR 5mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Nasopharyngitis.||15.2975|0.4172|0.2756
72336823|NCT00909545|144197294|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.4211|STANDARD_ERROR_OF_MEAN|0.8584||0.07|TWO_SIDED|95.0|0.8217|23.7875|||Fisher Exact|||One-sided Fisher's exact test will be used to compare Isradipine CR 10mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Nasopharyngitis.||23.7875|0.8217|0.07
72336824|NCT00909545|144197294|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.4|STANDARD_ERROR_OF_MEAN|0.9174||0.2953|TWO_SIDED|95.0|0.3975|14.4919|||Fisher Exact|||One-sided Fisher's exact test will be used to compare Isradipine CR 20mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Nasopharyngitis.||14.4919|0.3975|0.2953
72336825|NCT00909545|144197295|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.15|STANDARD_ERROR_OF_MEAN|0.8719||0.6049|TWO_SIDED|95.0|0.2082|6.3508|||Fisher Exact|||One-sided Fisher's exact test will be used to compare Isradipine CR 5mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Headache.||6.3508|0.2082|0.6049
72336826|NCT00909545|144197295|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.3|STANDARD_ERROR_OF_MEAN|0.7704||0.2327|TWO_SIDED|95.0|0.5081|10.4105|||Fisher Exact|||One-sided Fisher's exact test will be used to compare Isradipine CR 10mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Headache.||10.4105|0.5081|0.2327
72336827|NCT00909545|144197295|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.5333|STANDARD_ERROR_OF_MEAN|0.8227||0.4534|TWO_SIDED|95.0|0.3057|7.6897|||Fisher Exact|||One-sided Fisher's exact test will be used to compare Isradipine CR 20mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Headache.||7.6897|0.3057|0.4534
72336828|NCT00909545|144197296|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.7302|STANDARD_ERROR_OF_MEAN|0.9616||0.7852|TWO_SIDED|95.0|0.1109|4.8065|||Fisher Exact|||One-sided Fisher's exact test will be used to compare Isradipine CR 5mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Constipation.||4.8065|0.1109|0.7852
72336829|NCT00909545|144197296|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.0|STANDARD_ERROR_OF_MEAN|0.8681||0.666|TWO_SIDED|95.0|0.1824|5.482|||Fisher Exact|||One-sided Fisher's exact test will be used to compare Isradipine CR 10mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Constipation.||5.4820|0.1824|0.666
72336830|NCT00909545|144197296|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.5333|STANDARD_ERROR_OF_MEAN|0.8227||0.4534|TWO_SIDED|95.0|0.3057|7.6897|||Fisher Exact|||One-sided Fisher's exact test will be used to compare Isradipine CR 20mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Constipation.||7.6897|0.3057|0.4534
72336831|NCT00909545|144197297|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.5455|STANDARD_ERROR_OF_MEAN|1.2596||0.8589|TWO_SIDED|95.0|0.0462|6.4433|||Fisher Exact|||One-sided Fisher's exact test will be used to compare Isradipine CR 5mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Fatigue.||6.4433|0.0462|0.8589
72336832|NCT00909545|144197297|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.5652|STANDARD_ERROR_OF_MEAN|0.9584||0.5|TWO_SIDED|95.0|0.2392|10.241|||Fisher Exact|||One-sided Fisher's exact test will be used to compare Isradipine CR 10mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Fatigue.||10.2410|0.2392|0.5000
72336833|NCT00909545|144197297|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.7143|STANDARD_ERROR_OF_MEAN|0.9605||0.4609|TWO_SIDED|95.0|0.2609|11.2639|||Fisher Exact|||One-sided Fisher's exact test will be used to compare Isradipine CR 20mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Fatigue.||11.2639|0.2609|0.4609
72336834|NCT00909545|144197298|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.7302|STANDARD_ERROR_OF_MEAN|0.9616||0.7852|TWO_SIDED|95.0|0.1109|4.8065|||Fisher Exact|||One-sided Fisher's exact test will be used to compare Isradipine CR 5mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Nausea.||4.8065|0.1109|0.7852
72336835|NCT00909545|144197298|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.3067|STANDARD_ERROR_OF_MEAN|1.1912||0.9448|TWO_SIDED|95.0|0.0297|3.1612|||Fisher Exact|||One-sided Fisher's exact test will be used to compare Isradipine CR 10mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Nausea.||3.1612|0.0297|0.9448
72336836|NCT00909545|144197298|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.697|STANDARD_ERROR_OF_MEAN|0.9604||0.7996|TWO_SIDED|95.0|0.1061|4.5779|||Fisher Exact|||One-sided Fisher's exact test will be used to compare Isradipine CR 20mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Nausea.||4.5779|0.1061|0.7996
72336837|NCT00909545|144197299|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.381|STANDARD_ERROR_OF_MEAN|1.2599||0.4532|TWO_SIDED|95.0|0.2015|28.1366|||Fisher Exact|||One-sided Fisher's exact test will be used to compare Isradipine CR 5mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Tract Infection.||28.1366|0.2015|0.4532
72336838|NCT00909545|144197299|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.9524|STANDARD_ERROR_OF_MEAN|1.1347||0.0953|TWO_SIDED|95.0|0.6439|55.0272|||Fisher Exact|||One-sided Fisher's exact test will be used to compare Isradipine CR 10mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Tract Infection.||55.0272|0.6439|0.0953
72336839|NCT00909545|144197300|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.8|STANDARD_ERROR_OF_MEAN|0.9617||0.4402||95.0|0.2733|11.8558|||Fisher Exact|||One-sided Fisher's exact test will be used to compare Isradipine CR 5mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Depression.||11.8558|0.2733|0.4402
72336840|NCT00909545|144197300|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.48|STANDARD_ERROR_OF_MEAN|1.2577||0.8824|TWO_SIDED|95.0|0.0408|5.6461|||Fisher Exact|||One-sided Fisher's exact test will be used to compare Isradipine CR 10mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Depression.||5.6461|0.0408|0.8824
72336841|NCT00909545|144197300|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.0909|STANDARD_ERROR_OF_MEAN|1.0428||0.6641|TWO_SIDED|95.0|0.1413|8.4197|||Fisher Exact|||One-sided Fisher's exact test will be used to compare Isradipine CR 20mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Depression.||8.4197|0.1413|0.6641
72336842|NCT00909545|144197301|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.8|STANDARD_ERROR_OF_MEAN|0.9617||0.4402|TWO_SIDED|95.0|0.2733|11.8558|||Fisher Exact|||One-sided Fisher's exact test will be used to compare Isradipine CR 5mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Somnolence.||11.8558|0.2733|0.4402
72336843|NCT00909545|144197301|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.0|STANDARD_ERROR_OF_MEAN|1.0409||0.6951|TWO_SIDED|95.0|0.13|7.6906|||Fisher Exact|||One-sided Fisher's exact test will be used to compare Isradipine CR 10mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Somnolence.||7.6906|0.1300|0.6951
72336844|NCT00909545|144197302|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.8|STANDARD_ERROR_OF_MEAN|0.9617||0.4402|TWO_SIDED|95.0|0.2733|11.8558|||Fisher Exact|||One-sided Fisher's exact test will be used to compare Isradipine CR 5mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Insomnia .||11.8558|0.2733|0.4402
72336845|NCT00909545|144197302|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.48|STANDARD_ERROR_OF_MEAN|1.2577||0.8824|TWO_SIDED|95.0|0.0408|5.6461|||Fisher Exact|||One-sided Fisher's exact test will be used to compare Isradipine CR 10mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Insomnia .||5.6461|0.0408|0.8824
72336846|NCT00909545|144197302|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.5217|STANDARD_ERROR_OF_MEAN|1.2594||0.8673|TWO_SIDED|95.0|0.0442|6.1537|||Fisher Exact|||One-sided Fisher's exact test will be used to compare Isradipine CR 20mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Insomnia .||6.1537|0.0442|0.8673
72336847|NCT00909545|144197303|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.3485|STANDARD_ERROR_OF_MEAN|1.1919||0.9294|TWO_SIDED|95.0|0.0337|3.6084|||Fisher Exact|||One-sided Fisher's exact test will be used to compare Isradipine CR 5mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Dyspepsia .||3.6084|0.0337|0.9294
72336848|NCT00909545|144197303|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.3067|STANDARD_ERROR_OF_MEAN|1.1912||0.9448|TWO_SIDED|95.0|0.0297|3.1612|||Fisher Exact|||One-sided Fisher's exact test will be used to compare Isradipine CR 10mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Dyspepsia .||3.1612|0.0297|0.9448
72336849|NCT00909545|144197303|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.3333|STANDARD_ERROR_OF_MEAN|1.1924||0.9351|TWO_SIDED|95.0|0.0322|3.4459|||Fisher Exact|||One-sided Fisher's exact test will be used to compare Isradipine CR 20mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Dyspepsia .||3.4459|0.0322|0.9351
72336850|NCT00909545|144197304|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.5455|STANDARD_ERROR_OF_MEAN|1.2596||0.8589|TWO_SIDED|95.0|0.0462|6.4433|||Fisher Exact|||One-sided Fisher's exact test will be used to compare Isradipine CR 5mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Diarrhoea.||6.4433|0.0462|0.8589
72336851|NCT00909545|144197304|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.0|STANDARD_ERROR_OF_MEAN|1.0409||0.6951|TWO_SIDED|95.0|0.13|7.6906|||Fisher Exact|||One-sided Fisher's exact test will be used to compare Isradipine CR 10mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Diarrhoea.||7.6906|0.1300|0.6951
72336852|NCT00909545|144197304|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.5217|STANDARD_ERROR_OF_MEAN|1.2594||0.8673|TWO_SIDED|95.0|0.0442|6.1537|||Fisher Exact|||One-sided Fisher's exact test will be used to compare Isradipine CR 20mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Diarrhoea.||6.1537|0.0442|0.8673
72336853|NCT00909545|144197305|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.7302|STANDARD_ERROR_OF_MEAN|0.9616||0.7852|TWO_SIDED|95.0|0.1109|4.8065|||Fisher Exact|||One-sided Fisher's exact test will be used to compare Isradipine CR 5mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Sinusitis.||4.8065|0.1109|0.7852
72336854|NCT00909545|144197305|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.3067|STANDARD_ERROR_OF_MEAN|1.1912||0.9448|TWO_SIDED|95.0|0.0297|3.1612|||Fisher Exact|||One-sided Fisher's exact test will be used to compare Isradipine CR 10mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Sinusitis.||3.1612|0.0297|0.9448
72336855|NCT00909545|144197306|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.0833|STANDARD_ERROR_OF_MEAN|1.2576||0.5|TWO_SIDED|95.0|0.1771|24.5057|||Fisher Exact|||One-sided Fisher's exact test will be used to compare Isradipine CR 10mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Back Pain.||24.5057|0.1771|0.5000
72336856|NCT00909545|144197306|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.5714|STANDARD_ERROR_OF_MEAN|1.192||0.2746|TWO_SIDED|95.0|0.3453|36.9408|||Fisher Exact|||One-sided Fisher's exact test will be used to compare Isradipine CR 20mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Back Pain.||36.9408|0.3453|0.2746
72336857|NCT00909545|144197307|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.1364|STANDARD_ERROR_OF_MEAN|1.4444||0.7236|TWO_SIDED|95.0|0.067|19.264|||Fisher Exact|||One-sided Fisher's exact test will be used to compare Isradipine CR 5mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Hypotension.||19.2640|0.0670|0.7236
72336858|NCT00909545|144197307|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.0833|STANDARD_ERROR_OF_MEAN|1.2576||0.5|TWO_SIDED|95.0|0.1771|24.5057|||Fisher Exact|||One-sided Fisher's exact test will be used to compare Isradipine CR 10mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Hypotension.||24.5057|0.1771|0.5000
72336859|NCT00909545|144197307|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.2727|STANDARD_ERROR_OF_MEAN|1.2592||0.4694|TWO_SIDED|95.0|0.1926|26.8124|||Fisher Exact|||One-sided Fisher's exact test will be used to compare Isradipine CR 20mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Hypotension.||26.8124|0.1926|0.4694
72336860|NCT04065074|144197308|OTHER|Proportion of Successful Administrations|Proportion of Successful Administrations|0.75|||||TWO_SIDED|90.0|0.51|0.9||||||||0.90|0.51|
72336861|NCT02437305|144197315|SUPERIORITY_OR_OTHER|||||||0.048||||||P-value compares the increase in skin self-exams from pre-intervention to 2-months follow-up between the 2 groups.|McNemar|||||||0.048
72336862|NCT02437305|144197316|SUPERIORITY_OR_OTHER||||||>|0.5||||||P-value compares the increase in knowledge from pre-intervention to 2-months follow-up between the 2 groups.|McNemar|||||||>0.50
72336863|NCT01071200|144197329|SUPERIORITY_OR_OTHER|||||||0.07||95.0|||||Wilcoxon two sample test|||Change at hCG day : Wilcoxon two sample test was used to calculate p-value.||||0.07
72336864|NCT03730961|144197346|SUPERIORITY|Drug - placebo|Mean Difference (Net)|-448.0||||0.0021|TWO_SIDED|95.0|-714.0|-183.0|||t-test, 2 sided|||||-183|-714|0.0021
72336865|NCT03730961|144197346|SUPERIORITY|Percent change Drug - placebo|Mean Difference (Net)|-22.1||||0.0222|TWO_SIDED|95.0|-40.7|-3.51|||t-test, 2 sided|||||-3.51|-40.7|0.0222
72336866|NCT03730961|144197347|SUPERIORITY|Drug - placebo, 0-4 hours after furosemide|Mean Difference (Net)|-4.25||||0.0163|TWO_SIDED|95.0|-7.63|-0.876|||t-test, 2 sided|||||-0.876|-7.63|0.0163
72336867|NCT03730961|144197347|SUPERIORITY|Percent change Drug - placebo, 0-4 hours after furosemide|Mean Difference (Net)|-15.0||||0.2018|TWO_SIDED|95.0|-38.8|8.77|||t-test, 2 sided|||||8.77|-38.8|0.2018
72336868|NCT03730961|144197347|SUPERIORITY|Drug - placebo, 0-8 hours after start of infusion|Mean Difference (Net)|-3.61||||0.0526|TWO_SIDED|95.0|-7.27|0.0446|||t-test, 2 sided|||||0.0446|-7.27|0.0526
72336869|NCT03730961|144197347|SUPERIORITY|Percent change Drug - placebo, 0-8 hours after start of infusion|Mean Difference (Net)|-14.9||||0.2076|TWO_SIDED|95.0|-38.8|9.0|||t-test, 2 sided|||||9|-38.8|0.2076
72336870|NCT03730961|144197348|SUPERIORITY|Drug - placebo, 0-4 hours after furosemide|Mean Difference (Net)|0.431||||0.1621|TWO_SIDED|95.0|-0.189|1.05|||t-test, 2 sided|||||1.05|-0.189|0.1621
72336871|NCT03730961|144197348|SUPERIORITY|Percent change Drug - placebo, 0-4 hours after furosemide|Mean Difference (Net)|32.0||||0.0338|TWO_SIDED|95.0|2.72|61.3|||t-test, 2 sided|||||61.3|2.72|0.0338
72336872|NCT03730961|144197348|SUPERIORITY|Drug - placebo, 0-8 hours after start of infusion|Mean Difference (Net)|0.766||||0.06|TWO_SIDED|95.0|-0.0353|1.57|||t-test, 2 sided|||||1.57|-0.0353|0.0600
72336873|NCT03730961|144197348|SUPERIORITY|Percent change Drug - placebo, 0-8 hours after start of infusion|Mean Difference (Net)|33.5||||0.028|TWO_SIDED|95.0|4.02|63.0|||t-test, 2 sided|||||63|4.02|0.0280
72336874|NCT03730961|144197351|SUPERIORITY||Difference between drug and placebo|-4.0|STANDARD_DEVIATION|4.74||||||||||||||||
72336875|NCT01527513|144197362|NON_INFERIORITY_OR_EQUIVALENCE|"A 121ms non-inferiority margin was selected based on a previous study with Cognitive Drug Research (CDR) system comparing newly diagnosed patients to a healthy normative sample.~Assuming a Standard Deviation (SD) of 202.3 for the Power of Attention score, a total of 102 patients in the PP population would provide 80% power to reject the null hypothesis that the mean increase from baseline Power of Attention was at least 121 ms smaller in the placebo group."|Mean Difference (Final Values)|33.2001||||0.7|TWO_SIDED|95.0|-137.593|203.993|||95% CI lower bound vs non-inf margin|||||203.993|-137.593|0.700
72336876|NCT01527513|144197363|NON_INFERIORITY_OR_EQUIVALENCE|"A 121ms non-inferiority margin was selected based on a previous study with Cognitive Drug Research (CDR) system comparing newly diagnosed patients to a healthy normative sample.~Assuming a Standard Deviation (SD) of 202.3 for the Power of Attention score, a total of 102 patients in the PP population would provide 80% power to reject the null hypothesis that the mean increase from baseline Power of Attention was at least 121 ms smaller in the placebo group."|95% CI lower bound vs non-inf margin|33.2001|||<|0.7|TWO_SIDED|95.0|-137.593|203.993|||ANCOVA||The predefined non-inferiority margin was -121ms.|||203.993|-137.593|<0.700
72336877|NCT04465877|144197368|SUPERIORITY||Mean Difference (Final Values)|-2.12||||0.956|TWO_SIDED|95.0|-79.67|75.42|||Mixed Models Analysis|||Difference between change from baseline in PPG (AUEC0-4) value for JTT-662 5 mg and placebo on Day 1||75.42|-79.67|0.956
72336878|NCT04465877|144197368|SUPERIORITY||Mean Difference (Final Values)|0.33||||0.995|TWO_SIDED|95.0|-105.41|106.07|||Mixed Models Analysis|||Difference between change from baseline in PPG (AUEC0-4) value for JTT-662 5 mg and placebo on Day 14||106.07|-105.41|0.995
72336879|NCT04465877|144197368|SUPERIORITY||Mean Difference (Final Values)|-59.35||||0.366|TWO_SIDED|95.0|-191.15|72.45|||Mixed Models Analysis|||Difference between change from baseline in PPG (AUEC0-4) value for JTT-662 5 mg and placebo on Day 28||72.45|-191.15|0.366
72336880|NCT04465877|144197368|SUPERIORITY||Mean Difference (Final Values)|-100.02||||0.016|TWO_SIDED|95.0|-179.96|-20.08|||Mixed Models Analysis|||Difference between change from baseline in PPG (AUEC0-4) value for JTT-662 10 mg and placebo on Day 1||-20.08|-179.96|0.016
72336881|NCT04465877|144197368|SUPERIORITY||Mean Difference (Final Values)|-137.85||||0.014|TWO_SIDED|95.0|-245.28|-30.43|||Mixed Models Analysis|||Difference between change from baseline in PPG (AUEC0-4) value for JTT-662 10 mg and placebo on Day 14||-30.43|-245.28|0.014
72336882|NCT04465877|144197368|SUPERIORITY||Mean Difference (Final Values)|-229.04||||0.001|TWO_SIDED|95.0|-362.17|-95.91|||Mixed Models Analysis|||Difference between change from baseline in PPG (AUEC0-4) value for JTT-662 10 mg and placebo on Day 28||-95.91|-362.17|0.001
72336883|NCT04465877|144197368|SUPERIORITY||Mean Difference (Final Values)|-89.98||||0.025|TWO_SIDED|95.0|-167.62|-12.33|||Mixed Models Analysis|||Difference between change from baseline in PPG (AUEC0-4) value for JTT-662 20 mg and placebo on Day 1||-12.33|-167.62|0.025
72336884|NCT04465877|144197368|SUPERIORITY||Mean Difference (Final Values)|-222.02|||<|0.001|TWO_SIDED|95.0|-326.54|-117.51|||Mixed Models Analysis|||Difference between change from baseline in PPG (AUEC0-4) value for JTT-662 20 mg and placebo on Day 14||-117.51|-326.54|<0.001
72336885|NCT04465877|144197368|SUPERIORITY||Mean Difference (Final Values)|-248.82|||<|0.001|TWO_SIDED|95.0|-379.35|-118.28|||Mixed Models Analysis|||Difference between change from baseline in PPG (AUEC0-4) value for JTT-662 20 mg and placebo on Day 28||-118.28|-379.35|<0.001
72336886|NCT00395135|144197370|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|3.6|||<|0.0001|TWO_SIDED|95.0|3.0|4.2|||ANCOVA|||||4.2|3.0|<0.0001
72336887|NCT00395135|144197372|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion (%)|-3.67|||<|0.001|TWO_SIDED|95.0|-4.09|-3.25|||ANCOVA|||||-3.25|-4.09|<0.001
72336888|NCT00395135|144197373|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion (%)|-2.58|||<|0.001|TWO_SIDED|95.0|-3.29|-1.88|||ANCOVA|||||-1.88|-3.29|<0.001
72336889|NCT00395135|144197373|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion (%)|1.64|||<|0.001|TWO_SIDED|95.0|1.1|2.19|||ANCOVA|||||2.19|1.10|<0.001
72336890|NCT04962230|144197379|OTHER|PF-07321332/ritonavir administered alone was the Reference treatment and PF-07321332/ritonavir coadministered with carbamazepine was the Test treatment.|specify in comments|56.82||||0.05|TWO_SIDED|90.0|47.04|68.62|||Mixed Models Analysis||"Mixed Model was fitted to obtain:~1.Ratio of adjusted geometric means 2.90% CI for the ratios"|||68.62|47.04|0.05
72336891|NCT04962230|144197380|OTHER|PF-07321332/ritonavir administered alone was the Reference treatment and PF-07321332/ritonavir coadministered with carbamazepine was the Test treatment.|Specified in comments|44.5||||0.05|TWO_SIDED|90.0|33.77|58.65|||Mixed Models Analysis||"Mixed Model was fitted to obtain:~1.Ratio of adjusted geometric means 2.90% CI for the ratios"|||58.65|33.77|0.05
72336892|NCT04962230|144197381|OTHER|PF-07321332/ritonavir administered alone was the Reference treatment and PF-07321332/ritonavir coadministered with carbamazepine was the Test treatment.|Specified in comments|25.59||||0.05|TWO_SIDED|90.0|18.76|34.91|||Mixed Models Analysis||"Mixed Model was fitted to obtain:~1.Ratio of adjusted geometric means 2.90% CI for the ratios"|||34.91|18.76|0.05
72336893|NCT04962230|144197382|OTHER|PF-07321332/ritonavir administered alone was the Reference treatment and PF-07321332/ritonavir coadministered with carbamazepine was the Test treatment.|Specified in comments|16.57||||0.05|TWO_SIDED|90.0|13.32|20.6|||Mixed Models Analysis||"Mixed Model was fitted to obtain:~1.Ratio of adjusted geometric means 2.90% CI for the ratios"|||20.60|13.32|0.05
72336894|NCT04962230|144197388|OTHER|PF-07321332/ritonavir administered alone was the Reference treatment and PF-07321332/ritonavir coadministered with carbamazepine was the Test treatment.|Specified in comments|44.59||||0.05|TWO_SIDED|90.0|33.99|58.5|||Mixed Models Analysis||"Mixed Model was fitted to obtain:~1.Ratio of adjusted geometric means 2.90% CI for the ratios"|||58.50|33.99|0.05
72336895|NCT04962230|144197393|OTHER|PF-07321332/ritonavir administered alone was the Reference treatment and PF-07321332/ritonavir coadministered with carbamazepine was the Test treatment.|Specified in comments|12.92||||0.05|TWO_SIDED|90.0|9.28|17.99|||Mixed Models Analysis||"Mixed Model was fitted to obtain:~1.Ratio of adjusted geometric means 2.90% CI for the ratios"|||17.99|9.28|0.05
72336896|NCT03831880|144197408|SUPERIORITY||Mean Difference (Final Values)|-15.49|||<|0.0001|TWO_SIDED|95.0|-19.71|-11.27||95% CI: Model-based difference in means. Results were based on a linear mixed effects model including sequence, period, and treatment as fixed effects and participant within sequence and within-participant error as random effects.|Mixed Models Analysis|||||-11.27|-19.71|<0.0001
72336897|NCT03831880|144197410|SUPERIORITY||Mean Difference (Final Values)|-5.39||||0.0017|TWO_SIDED|95.0|-8.69|-2.09||95% CI: Model-based difference in means. Results were based on a linear mixed effects model including sequence, period, and treatment as fixed effects and participant within sequence and within-participant error as random effects.|Mixed Models Analysis|||||-2.09|-8.69|0.0017
72336898|NCT03831880|144197412|SUPERIORITY||Mean Difference (Final Values)|-13.6|||<|0.0001|TWO_SIDED|95.0|-19.74|-7.45||95% CI: Model-based difference in means. Results were based on a linear mixed effects model including sequence, period, and treatment as fixed effects and participant within sequence and within-participant error as random effects.|Mixed Models Analysis|||||-7.45|-19.74|<0.0001
72336899|NCT03831880|144197414|SUPERIORITY||Mean Difference (Final Values)|-24.34|||<|0.0001|TWO_SIDED|95.0|-30.1|-18.57||95% CI: Model-based difference in means. Results were based on a linear mixed effects model including sequence, period, and treatment as fixed effects and participant within sequence and within-participant error as random effects.|Mixed Models Analysis|||||-18.57|-30.10|<0.0001
72336900|NCT03831880|144197416|SUPERIORITY||Mean Difference (Final Values)|-7.83||||0.0739|TWO_SIDED|95.0|-16.42|0.77||95% CI: Model-based difference in means. Results were based on a linear mixed effects model including sequence, period, and treatment as fixed effects and participant within sequence and within-participant error as random effects.|Mixed Models Analysis|||||0.77|-16.42|0.0739
72336901|NCT03831880|144197418|SUPERIORITY||Mean Difference (Final Values)|-17.6|||<|0.0001|TWO_SIDED|95.0|-25.15|-10.06||95% CI: Model-based difference in means. Results were based on a linear mixed effects model including sequence, period, and treatment as fixed effects and participant within sequence and within-participant error as random effects.|Mixed Models Analysis|||||-10.06|-25.15|<0.0001
72336902|NCT03831880|144197420|SUPERIORITY||Mean Difference (Final Values)|0.71||||0.6137|TWO_SIDED|95.0|-2.09|3.51||95% CI: Model-based difference in means. Results were based on a linear mixed effects model including sequence, period, and treatment as fixed effects and participant within sequence and within-participant error as random effects.|Mixed Models Analysis|||||3.51|-2.09|0.6137
72336903|NCT03831880|144197422|SUPERIORITY||Mean Difference (Final Values)|0.56||||0.8404|TWO_SIDED|95.0|-5.29|6.41||95% CI: Model-based difference in means. Results were based on a linear mixed effects model including sequence, period, and treatment as fixed effects and participant within sequence and within-participant error as random effects.|Mixed Models Analysis|||||6.41|-5.29|0.8404
72336904|NCT03831880|144197424|SUPERIORITY||Mean Difference (Final Values)|-13.47|||<|0.0001|TWO_SIDED|95.0|-17.59|-9.35||95% CI: Model-based difference in means. Results were based on a linear mixed effects model including sequence, period, and treatment as fixed effects and participant within sequence and within-participant error as random effects.|Mixed Models Analysis|||||-9.35|-17.59|<0.0001
72336905|NCT03831880|144197426|SUPERIORITY||Mean Difference (Final Values)|-2.76||||0.0245|TWO_SIDED|95.0|-5.16|-0.36||95% CI: Model-based difference in means. Results were based on a linear mixed effects model including sequence, period, and treatment as fixed effects and participant within sequence and within-participant error as random effects.|Mixed Models Analysis|||||-0.36|-5.16|0.0245
72336906|NCT03831880|144197438|SUPERIORITY||Mean Difference (Final Values)|-14.58|||<|0.0001|TWO_SIDED|95.0|-18.72|-10.44||95% CI: Model-based difference in means. Results were based on a linear mixed effects model including sequence, period, and treatment as fixed effects and participant within sequence and within-participant error as random effects.|Mixed Models Analysis|||||-10.44|-18.72|<0.0001
72336907|NCT04346108|144197473|SUPERIORITY||Poisson Estimate|1.65|||||TWO_SIDED|95.0|0.73|3.15||||||||3.15|0.73|
72336908|NCT04346108|144197473|SUPERIORITY||Poisson Estimate|0.0|||||TWO_SIDED|95.0|0.0|0.0||||||||0.00|0.00|
72336909|NCT04346108|144197473|SUPERIORITY||Poisson Estimate|2.48|||||TWO_SIDED|95.0|1.34|4.13||||||||4.13|1.34|
72336910|NCT04346108|144197474|SUPERIORITY||Poisson Estimate|2.6|||||TWO_SIDED|95.0|1.02|5.3||||||||5.30|1.02|
72336911|NCT04346108|144197474|SUPERIORITY||Poisson Estimate|9.82|||||TWO_SIDED|95.0|2.82|23.82||||||||23.82|2.82|
72336912|NCT04346108|144197474|SUPERIORITY||Poisson Estimate|2.87|||||TWO_SIDED|95.0|1.37|5.18||||||||5.18|1.37|
72336913|NCT04346108|144197475|SUPERIORITY||Poisson Estimate|4.01||||||95.0|1.46|8.54||||||||8.54|1.46|
72336914|NCT04346108|144197475|SUPERIORITY||Poisson Estimate|3.07|||||TWO_SIDED|95.0|0.37|10.74||||||||10.74|0.37|
72336915|NCT04346108|144197475|SUPERIORITY||Poisson Estimate|5.87|||||TWO_SIDED|95.0|2.32|11.93||||||||11.93|2.32|
72336916|NCT04346108|144197476|SUPERIORITY||Poisson Estimate|0.0|||||TWO_SIDED|95.0|0.0|0.0||||||||0.0|0.0|
72336917|NCT04346108|144197476|SUPERIORITY||Poisson Estimate|0.13|||||TWO_SIDED|95.0|0.03|0.35||||||||0.35|0.03|
72336918|NCT04346108|144197476|SUPERIORITY||Poisson Estimate|0.0|||||TWO_SIDED|95.0|0.0|0.0||||||||0.00|0.00|
72336919|NCT04346108|144197477|SUPERIORITY||Poisson Estimate|0.0|||||TWO_SIDED|95.0|0.0|0.0||||||||0.00|0.00|
72427658|NCT02942004|144367030|SUPERIORITY||LS mean difference|0.01|STANDARD_ERROR_OF_MEAN|0.151||0.9401|TWO_SIDED|95.0|-0.29|0.31|||MMRM|||Agitation, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.31|-0.29|0.9401
72427659|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.15|STANDARD_ERROR_OF_MEAN|0.147||0.3201|TWO_SIDED|95.0|-0.44|0.15|||MMRM|||Agitation, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.15|-0.44|0.3201
72427660|NCT02942004|144367030|SUPERIORITY||LS mean difference|0.03|STANDARD_ERROR_OF_MEAN|0.144||0.8286|TWO_SIDED|95.0|-0.25|0.32|||MMRM|||Agitation, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.32|-0.25|0.8286
72427661|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.17|STANDARD_ERROR_OF_MEAN|0.162||0.3022|TWO_SIDED|95.0|-0.49|0.15|||MMRM|||Agitation, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.15|-0.49|0.3022
72427662|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.04|STANDARD_ERROR_OF_MEAN|0.158||0.8022|TWO_SIDED|95.0|-0.35|0.27|||MMRM|||Agitation, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.27|-0.35|0.8022
72427663|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.165||0.5665|TWO_SIDED|95.0|-0.42|0.23|||MMRM|||Agitation, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.23|-0.42|0.5665
72427664|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.04|STANDARD_ERROR_OF_MEAN|0.161||0.817|TWO_SIDED|95.0|-0.36|0.28|||MMRM|||Agitation, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.28|-0.36|0.8170
72427665|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.32|STANDARD_ERROR_OF_MEAN|0.155||0.0404|TWO_SIDED|95.0|-0.63|-0.01|||MMRM|||Agitation, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.01|-0.63|0.0404
72336920|NCT04346108|144197477|SUPERIORITY||Poisson Estimate|1.04|||||TWO_SIDED|95.0|0.25|2.76||||||||2.76|0.25|
72336921|NCT04346108|144197478|SUPERIORITY||Poisson Estimate|1.18|||||TWO_SIDED|95.0|0.38|2.68||||||||2.68|0.38|
72336922|NCT04346108|144197478|SUPERIORITY||Poisson Estimate|2.35|||||TWO_SIDED|95.0|0.91|4.82||||||||4.82|0.91|
72336923|NCT04346108|144197478|SUPERIORITY||Poisson Estimate|0.61|||||TWO_SIDED|95.0|0.07|2.15||||||||2.15|0.07|
72336924|NCT02159118|144197490|SUPERIORITY_OR_OTHER|||||||0.03|||||||Wilcoxon (Mann-Whitney)|||||||0.03
72336925|NCT02159118|144197491|SUPERIORITY_OR_OTHER|||||||0.65|||||||Wilcoxon (Mann-Whitney)|||||||0.65
72336926|NCT02159118|144197492|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
72427666|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.15|STANDARD_ERROR_OF_MEAN|0.151||0.3128|TWO_SIDED|95.0|-0.45|0.15|||MMRM|||Agitation, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.15|-0.45|0.3128
72336927|NCT02159118|144197493|SUPERIORITY_OR_OTHER|||||||0.01|||||||Wilcoxon (Mann-Whitney)|||||||0.01
72336928|NCT02159118|144197494|SUPERIORITY_OR_OTHER|||||||0.06|||||||Wilcoxon (Mann-Whitney)|||||||0.06
72336929|NCT02159118|144197495|SUPERIORITY_OR_OTHER|||||||0.93|||||||Wilcoxon (Mann-Whitney)|||||||0.93
72336930|NCT02159118|144197496|SUPERIORITY_OR_OTHER|||||||0.22|||||||Wilcoxon (Mann-Whitney)|||||||0.22
72336931|NCT02159118|144197497|SUPERIORITY_OR_OTHER|||||||0.51|||||||Wilcoxon (Mann-Whitney)|||||||0.51
72336932|NCT02159118|144197498|SUPERIORITY_OR_OTHER|||||||0.08|||||||Wilcoxon (Mann-Whitney)|||||||0.08
72336933|NCT00386477|144197499|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.55||||0.11||95.0|0.26|1.11|||Chi-squared, Corrected|||||1.11|0.26|0.11
72336934|NCT02648022|144197506|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.91||||0.07|TWO_SIDED|95.0|0.92|9.27|||Regression, Linear|Multivariable Regression Analysis||||9.27|0.92|0.07
72336935|NCT00901511|144197520|SUPERIORITY||Median Difference (Final Values)|12.0||||0.0078|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||Calculated as the median time to rescue WLL in the GM-CSF Group minus the median the time to rescue WLL in the Control Group|||||0.0078
72336936|NCT00901511|144197521|SUPERIORITY||Risk Ratio (RR)|7.0||||0.0152|TWO_SIDED|95.0|1.6|39.9|||Fisher Exact||Calculated as risk ratio of rescue WLL in the Control Group compared to the risk ratio of rescue WLL in the GM-CSF Group|||39.9|1.60|0.0152
72336937|NCT00901511|144197522|SUPERIORITY||Mean Difference (Final Values)|9.5|||<|0.0001|TWO_SIDED|95.0|5.7|13.3|||Repeated measures ANOVA|Data was evaluated via repeated measures ANOVA after adjustment for baseline values, gender, age, and number of patients at risk at each time point.|Calculated as the between group difference in the mean PaO2 in the GM-CSF Group minus the between group difference in mean PaO2 in the Control Group|||13.3|5.7|<0.0001
72336938|NCT00901511|144197522|SUPERIORITY||Mean Difference (Final Values)|15.1|STANDARD_ERROR_OF_MEAN|6.16||0.0261|TWO_SIDED|95.0|2.04|28.16|||t-test, 2 sided||Calculated as the difference at the pre-WLL visit in the mean PaO2 in the GM-CSF Group minus the mean PaO2 in the Control Group|The secondary analysis includes evaluation of the difference in mean PaO2 between groups at the pre-WLL visit after imputation of missing data using a last observation carried forward method.||28.16|2.04|0.0261
72336939|NCT00901511|144197522|SUPERIORITY||Mean Difference (Final Values)|9.56|STANDARD_ERROR_OF_MEAN|6.36||0.1521|TWO_SIDED|95.0|3.92|23.03|||t-test, 2 sided||Calculated as the difference at the baseline visit in the mean PaO2 in the GM-CSF Group minus the mean PaO2 in the Control Group|The secondary analysis includes evaluation of the difference in mean PaO2 between groups at the baseline visit after imputation of missing data using a last observation carried forward method.||23.03|3.92|0.1521
72336940|NCT00901511|144197522|SUPERIORITY||Mean Difference (Final Values)|18.04|STANDARD_ERROR_OF_MEAN|5.56||0.0051|TWO_SIDED|95.0|6.26|29.82|||t-test, 2 sided||Calculated as the difference at the 1-month visit in the mean PaO2 in the GM-CSF Group minus the mean PaO2 in the Control Group|The secondary analysis includes evaluation of the difference in mean PaO2 between groups at the 1-month visit after imputation of missing data using a last observation carried forward method.||29.82|6.26|0.0051
72336941|NCT00901511|144197522|SUPERIORITY||Mean Difference (Final Values)|20.26|STANDARD_ERROR_OF_MEAN|4.54||0.0004|TWO_SIDED|95.0|10.63|29.88|||t-test, 2 sided||Calculated as the difference at the 3-month visit in the mean PaO2 in the GM-CSF Group minus the mean PaO2 in the Control Group|The secondary analysis includes evaluation of the difference in mean PaO2 between groups at the 3-month visit after imputation of missing data using a last observation carried forward method.||29.88|10.63|0.0004
72336942|NCT00901511|144197522|SUPERIORITY||Mean Difference (Final Values)|19.91|STANDARD_ERROR_OF_MEAN|5.89||0.0038|TWO_SIDED|95.0|7.43|32.4|||t-test, 2 sided||Calculated as the difference at the 6-month visit in the mean PaO2 in the GM-CSF Group minus the mean PaO2 in the Control Group|The secondary analysis includes evaluation of the difference in mean PaO2 between groups at the 6-month visit after imputation of missing data using a last observation carried forward method.||32.40|7.43|0.0038
72336943|NCT00901511|144197522|SUPERIORITY||Mean Difference (Final Values)|16.92|STANDARD_ERROR_OF_MEAN|6.15||0.0149|TWO_SIDED|95.0|3.81|30.03|||t-test, 2 sided||Calculated as the difference at the 10-month visit in the mean PaO2 in the GM-CSF Group minus the mean PaO2 in the Control Group|The secondary analysis includes evaluation of the difference in mean PaO2 between groups at the 10-month visit after imputation of missing data using a last observation carried forward method.||30.03|3.81|0.0149
72336944|NCT00901511|144197522|SUPERIORITY||Mean Difference (Final Values)|19.02|STANDARD_ERROR_OF_MEAN|6.97||0.0148|TWO_SIDED|95.0|4.26|33.79|||t-test, 2 sided||Calculated as the difference at the 18-month visit in the mean PaO2 in the GM-CSF Group minus the mean PaO2 in the Control Group|The secondary analysis includes evaluation of the difference in mean PaO2 between groups at the 18-month visit after imputation of missing data using a last observation carried forward method.||33.79|4.26|0.0148
72336945|NCT00901511|144197522|SUPERIORITY||Mean Difference (Final Values)|11.0|STANDARD_ERROR_OF_MEAN|6.62||0.1158|TWO_SIDED|95.0|-3.02|25.02|||t-test, 2 sided|||The secondary analysis includes evaluation of the difference in mean PaO2 between groups at the 30-month visit after imputation of missing data using a last observation carried forward method.|Calculated as the difference at the 30-month visit in the mean PaO2 in the GM-CSF Group minus the mean PaO2 in the Control Group|25.02|-3.02|0.1158
72336946|NCT00901511|144197523|SUPERIORITY||Mean Difference (Final Values)|-10.1|||<|0.0001|TWO_SIDED|95.0|-14.8|-5.4|||Repeated measures ANOVA|Data was evaluated via repeated measures ANOVA after adjustment for baseline values, gender, age, and number of patients at risk at each time point.|Calculated as the between group difference in the mean value of A-aDO2 in the GM-CSF Group minus the mean value of A-aDO2 in the Control Group|Primary analysis||-5.4|-14.8|<0.0001
72336947|NCT00901511|144197523|SUPERIORITY||Mean Difference (Final Values)|-12.46|STANDARD_ERROR_OF_MEAN|6.0||0.0545|TWO_SIDED|95.0|-25.19|0.27|||t-test, 2 sided||Calculated as the difference at the pre-WLL visit in the mean A-aDO2 in the GM-CSF Group minus the mean A-aDO2 in the Control Group|The secondary analysis includes evaluation of the difference in mean A-aDO2 between groups at the pre-WLL visit after imputation of missing data using a last observation carried forward method.||0.27|-25.19|0.0545
72336948|NCT00901511|144197523|SUPERIORITY||Mean Difference (Final Values)|-7.08|STANDARD_ERROR_OF_MEAN|6.34||0.2802|TWO_SIDED|95.0|-20.52|6.35|||t-test, 2 sided||Calculated as the difference at the baseline visit in the mean A-aDO2 in the GM-CSF Group minus the mean A-aDO2 in the Control Group|The secondary analysis includes evaluation of the difference in mean A-aDO2 between groups at the baseline visit after imputation of missing data using a last observation carried forward method.||6.35|-20.52|0.2802
72336949|NCT00901511|144197523|SUPERIORITY||Mean Difference (Final Values)|-16.81|STANDARD_ERROR_OF_MEAN|6.16||0.0148|TWO_SIDED|95.0|-29.85|-3.76|||t-test, 2 sided||Calculated as the difference at the 1-month visit in the mean A-aDO2 in the GM-CSF Group minus the mean A-aDO2 in the Control Group|The secondary analysis includes evaluation of the difference in mean A-aDO2 between groups at the 1-month visit after imputation of missing data using a last observation carried forward method.||-3.76|-29.85|0.0148
72336950|NCT00901511|144197523|SUPERIORITY||Mean Difference (Final Values)|-18.77|STANDARD_ERROR_OF_MEAN|4.91||0.0015|TWO_SIDED|95.0|-29.18|-8.36|||t-test, 2 sided||Calculated as the difference at the 3-month visit in the mean A-aDO2 in the GM-CSF Group minus the mean A-aDO2 in the Control Group|The secondary analysis includes evaluation of the difference in mean A-aDO2 between groups at the 3 -month visit after imputation of missing data using a last observation carried forward method.||-8.36|-29.18|0.0015
72336951|NCT00901511|144197523|SUPERIORITY||Mean Difference (Final Values)|-19.09|STANDARD_ERROR_OF_MEAN|5.85||0.0049|TWO_SIDED|95.0|-31.49|-6.7|||t-test, 2 sided||Calculated as the difference at the 6-month visit in the mean A-aDO2 in the GM-CSF Group minus the mean A-aDO2 in the Control Group|The secondary analysis includes evaluation of the difference in mean A-aDO2 between groups at the 6-month visit after imputation of missing data using a last observation carried forward method.||-6.70|-31.49|0.0049
72336952|NCT00901511|144197523|SUPERIORITY||Mean Difference (Final Values)|-15.85|STANDARD_ERROR_OF_MEAN|5.84||0.0152|TWO_SIDED|95.0|-28.23|-3.48|||t-test, 2 sided||Calculated as the difference at the 10-month visit in the mean A-aDO2 in the GM-CSF Group minus the mean A-aDO2 in the Control Group|The secondary analysis includes evaluation of the difference in mean A-aDO2 between groups at the 10-month visit after imputation of missing data using a last observation carried forward method.||-3.48|-28.23|0.0152
72336953|NCT00901511|144197523|SUPERIORITY||Mean Difference (Final Values)|-17.01|STANDARD_ERROR_OF_MEAN|6.27||0.0154|TWO_SIDED|95.0|-30.31|-3.71|||t-test, 2 sided||Calculated as the difference at the 18-month visit in the mean A-aDO2 in the GM-CSF Group minus the mean A-aDO2 in the Control Group|The secondary analysis includes evaluation of the difference in mean A-aDO2 between groups at the 18-month visit after imputation of missing data using a last observation carried forward method.||-3.71|-30.31|0.0154
72336954|NCT00901511|144197523|SUPERIORITY||Mean Difference (Final Values)|-11.01|STANDARD_ERROR_OF_MEAN|6.15||0.0921|TWO_SIDED|95.0|-24.05|2.02|||t-test, 2 sided||Calculated as the difference at the 30-month visit in the mean A-aDO2 in the GM-CSF Group minus the mean A-aDO2 in the Control Group|The secondary analysis includes evaluation of the difference in mean A-aDO2 between groups at the 30-month visit after imputation of missing data using a last observation carried forward method.||2.02|-24.05|0.0921
72336955|NCT00901511|144197524|SUPERIORITY||Mean Difference (Final Values)|11.6||||0.022|TWO_SIDED|95.0|1.9|21.3|||Repeated measures ANOVA|Data was evaluated via repeated measures ANOVA after adjustment for baseline values, gender, age, and number of patients at risk at each time point.|Calculated as the between group difference in the mean value of the DLCO in the GM-CSF Group minus the mean value of the DLCO in the Control Group|Primary Analysis||21.3|1.9|0.0220
72336956|NCT00901511|144197524|SUPERIORITY||Mean Difference (Final Values)|8.29|STANDARD_ERROR_OF_MEAN|7.96||0.3186|TWO_SIDED|95.0|-9.06|25.63|||t-test, 2 sided||Calculated as the difference at the Pre-WLL visit in the mean DLCO in the GM-CSF Group minus the mean DLCO in the Control Group|The secondary analysis includes evaluation of the difference in mean DLCO between groups at the Pre-WLL visit after imputation of missing data using a last observation carried forward method.||25.63|-9.06|0.3186
72336957|NCT00901511|144197524|SUPERIORITY||Mean Difference (Final Values)|5.56|STANDARD_ERROR_OF_MEAN|6.58||0.4111|TWO_SIDED|95.0|-8.4|19.51|||t-test, 2 sided||Calculated as the difference at the baseline visit in the mean DLCO in the GM-CSF Group minus the mean DLCO in the Control Group|The secondary analysis includes evaluation of the difference in mean DLCO between groups at the baseline visit after imputation of missing data using a last observation carried forward method.||19.51|-8.40|0.4111
72336958|NCT00901511|144197524|SUPERIORITY||Mean Difference (Final Values)|12.89|STANDARD_ERROR_OF_MEAN|6.53||0.0658|TWO_SIDED|95.0|-0.95|26.73|||t-test, 2 sided||Calculated as the difference at the 1-month visit in the mean DLCO in the GM-CSF Group minus the mean DLCO in the Control Group|The secondary analysis includes evaluation of the difference in mean DLCO between groups at the 1-month visit after imputation of missing data using a last observation carried forward method.||26.73|-0.95|0.0658
72336959|NCT00901511|144197524|SUPERIORITY||Mean Difference (Final Values)|9.78|STANDARD_ERROR_OF_MEAN|7.81||0.2287|TWO_SIDED|95.0|-6.78|26.34|||t-test, 2 sided||Calculated as the difference at the 3-month visit in the mean DLCO in the GM-CSF Group minus the mean DLCO in the Control Group|The secondary analysis includes evaluation of the difference in mean DLCO between groups at the 3-month visit after imputation of missing data using a last observation carried forward method.||26.34|-6.78|0.2287
72336960|NCT00901511|144197524|SUPERIORITY||Mean Difference (Final Values)|12.86|STANDARD_ERROR_OF_MEAN|8.37||0.1432|TWO_SIDED|95.0|-4.86|30.64|||t-test, 2 sided||Calculated as the difference at the 6-month visit in the mean DLCO in the GM-CSF Group minus the mean DLCO in the Control Group|The secondary analysis includes evaluation of the difference in mean DLCO between groups at the 6-month visit after imputation of missing data using a last observation carried forward method.||30.64|-4.86|0.1432
72336961|NCT00901511|144197524|SUPERIORITY||Mean Difference (Final Values)|11.78|STANDARD_ERROR_OF_MEAN|8.47||0.1833|TWO_SIDED|95.0|-6.17|29.73|||t-test, 2 sided||Calculated as the difference at the 10-month visit in the mean DLCO in the GM-CSF Group minus the mean DLCO in the Control Group|The secondary analysis includes evaluation of the difference in mean DLCO between groups at the 10-month visit after imputation of missing data using a last observation carried forward method.||29.73|-6.17|0.1833
72336962|NCT00901511|144197524|SUPERIORITY||Mean Difference (Final Values)|12.67|STANDARD_ERROR_OF_MEAN|9.23||0.1888|TWO_SIDED|95.0|-6.9|32.23|||t-test, 2 sided||Calculated as the difference at the 18-month visit in the mean DLCO in the GM-CSF Group minus the mean DLCO in the Control Group|The secondary analysis includes evaluation of the difference in mean DLCO between groups at the 18-month visit after imputation of missing data using a last observation carried forward method.||32.23|-6.90|0.1888
72336963|NCT00901511|144197524|SUPERIORITY||Mean Difference (Final Values)|4.22|STANDARD_ERROR_OF_MEAN|8.79||0.6374|TWO_SIDED|95.0|-14.41|22.85|||t-test, 2 sided||Calculated as the difference at the 30-month visit in the mean DLCO in the GM-CSF Group minus the mean DLCO in the Control Group|The secondary analysis includes evaluation of the difference in mean DLCO between groups at the 30-month visit after imputation of missing data using a last observation carried forward method.||22.85|-14.41|0.6374
72336964|NCT00901511|144197525|SUPERIORITY||Mean Difference (Final Values)|2.0||||0.532|TWO_SIDED|95.0|-5.3|9.9|||Repeated measures ANOVA|Data was evaluated via repeated measures ANOVA after adjustment for baseline values, gender, age, and number of patients at risk at each time point.|Calculated as the between group difference in the mean value of VC in the GM-CSF Group minus the mean value of VC in the Control Group|Primary Analysis||9.90|-5.30|0.5320
72336965|NCT00901511|144197525|SUPERIORITY||Mean Difference (Final Values)|3.21|STANDARD_ERROR_OF_MEAN|7.55||0.6772|TWO_SIDED|95.0|-13.09|19.52|||t-test, 2 sided||Calculated as the difference at the Pre-WLL visit in the mean VC in the GM-CSF Group minus the mean VC in the Control Group|The secondary analysis includes evaluation of the difference in mean VC between groups at the Pre-WLL visit after imputation of missing data using a last observation carried forward method.||19.52|-13.09|0.6772
72336966|NCT00901511|144197525|SUPERIORITY||Mean Difference (Final Values)|1.44|STANDARD_ERROR_OF_MEAN|6.7||0.832|TWO_SIDED|95.0|-12.52|15.64|||t-test, 2 sided||Calculated as the difference at the baseline visit in the mean VC in the GM-CSF Group minus the mean VC in the Control Group|The secondary analysis includes evaluation of the difference in mean VC between groups at the baseline visit after imputation of missing data using a last observation carried forward method.||15.64|-12.52|0.8320
72336967|NCT00901511|144197525|SUPERIORITY||Mean Difference (Final Values)|1.47|STANDARD_ERROR_OF_MEAN|7.82||0.8532|TWO_SIDED|95.0|-15.19|18.14|||t-test, 2 sided||Calculated as the difference at the 1-month visit in the mean VC in the GM-CSF Group minus the mean VC in the Control Group|The secondary analysis includes evaluation of the difference in mean VC between groups at the 1-month visit after imputation of missing data using a last observation carried forward method.||18.14|-15.19|0.8532
72336968|NCT00901511|144197525|SUPERIORITY||Mean Difference (Final Values)|2.22|STANDARD_ERROR_OF_MEAN|7.66||0.7752|TWO_SIDED|95.0|-14.0|18.44|||t-test, 2 sided||Calculated as the difference at the 3-month visit in the mean VC in the GM-CSF Group minus the mean VC in the Control Group|The secondary analysis includes evaluation of the difference in mean VC between groups at the 3-month visit after imputation of missing data using a last observation carried forward method.||18.44|-14.00|0.7752
72336969|NCT00901511|144197525|SUPERIORITY||Mean Difference (Final Values)|5.74|STANDARD_ERROR_OF_MEAN|8.65||0.5174|TWO_SIDED|95.0|-12.7|24.18|||t-test, 2 sided||Calculated as the difference at the 6-month visit in the mean value of VC in the GM-CSF Group minus the mean value of VC in the Control Group|The secondary analysis includes evaluation of the difference in mean VC between groups at the 6-month visit after imputation of missing data using a last observation carried forward method.||24.18|-12.70|0.5174
72336970|NCT00901511|144197525|SUPERIORITY||Mean Difference (Final Values)|3.67|STANDARD_ERROR_OF_MEAN|7.68||0.6393|TWO_SIDED|95.0|-12.61|19.94|||t-test, 2 sided||Calculated as the difference at the 10-month visit in the mean VC in the GM-CSF Group minus the mean VC in the Control Group|The secondary analysis includes evaluation of the difference in mean VC between groups at the 10-month visit after imputation of missing data using a last observation carried forward method.||19.94|-12.61|0.6393
72336971|NCT00901511|144197525|SUPERIORITY||Mean Difference (Final Values)|5.22|STANDARD_ERROR_OF_MEAN|8.26||0.5361|TWO_SIDED|95.0|-12.28|22.73|||t-test, 2 sided||Calculated as the difference at the 18-month visit in the mean VC in the GM-CSF Group minus the mean VC in the Control Group|The secondary analysis includes evaluation of the difference in mean VC between groups at the 18-month visit after imputation of missing data using a last observation carried forward method.||22.73|-12.28|0.5361
72336972|NCT00901511|144197525|SUPERIORITY||Mean Difference (Final Values)|1.67|STANDARD_ERROR_OF_MEAN|7.04||0.8159|TWO_SIDED|95.0|-13.26|16.6|||t-test, 2 sided|||The secondary analysis includes evaluation of the difference in mean VC between groups at the 30-month visit after imputation of missing data using a last observation carried forward method.|Calculated as the difference at the 30-month visit in the mean VC in the GM-CSF Group minus the mean VC in the Control Group|16.60|-13.26|0.8159
72336973|NCT00901511|144197526|SUPERIORITY||Mean Difference (Final Values)|-0.822||||0.053|TWO_SIDED|95.0|-1.7|0.01|||Repeated measures ANOVA|Data was evaluated via repeated measures ANOVA after adjustment for baseline values, gender, age, and number of patients at risk at each time point.|Calculated as the between group difference in the median value of the GGO Score in the GM-CSF Group minus the median value of the GGO Score in the Control Group|Primary Analysis||0.01|-1.70|0.0530
72336974|NCT00901511|144197526|SUPERIORITY||Median Difference (Final Values)|0.0|||>|0.9999|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||Calculated as the difference at the Pre-WLL visit in the median GGO Score in the GM-CSF Group minus the median GGO Score in the Control Group|The secondary analysis includes evaluation of the difference in median GGO Score between groups at the Pre-WLL visit after imputation of missing data using a last observation carried forward method.||||>0.9999
72336975|NCT00901511|144197526|SUPERIORITY||Median Difference (Final Values)|-1.0||||0.0332|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||Calculated as the difference at the 3-month visit in the median GGO Score in the GM-CSF Group minus the median GGO Score in the Control Group|The secondary analysis includes evaluation of the difference in median GGO Score between groups at the 3-month visit after imputation of missing data using a last observation carried forward method.||||0.0332
72336976|NCT00901511|144197526|SUPERIORITY||Median Difference (Final Values)|-1.0||||0.0676|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||Calculated as the difference at the 10-month visit in the median GGO Score in the GM-CSF Group minus the median GGO Score in the Control Group|The secondary analysis includes evaluation of the difference in median GGO Score between groups at the 10-month visit after imputation of missing data using a last observation carried forward method.||||0.0676
72336977|NCT00901511|144197526|SUPERIORITY||Median Difference (Final Values)|-1.0||||0.0629|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||Calculated as the difference at the 18-month visit in the median GGO Score in the GM-CSF Group minus the median GGO Score in the Control Group|The secondary analysis includes evaluation of the difference in median GGO Score between groups at the 18-month visit after imputation of missing data using a last observation carried forward method.||||0.0629
72336978|NCT00901511|144197526|SUPERIORITY||Median Difference (Final Values)|0.0|||>|0.9999|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||Calculated as the difference at the 30-month visit in the median GGO Score in the GM-CSF Group minus the median GGO Score in the Control Group|The secondary analysis includes evaluation of the difference in median GGO Score between groups at the 30-month visit after imputation of missing data using a last observation carried forward method.||||>0.9999
72336979|NCT00901511|144197527|SUPERIORITY||Mean Difference (Final Values)|-0.47||||0.001|TWO_SIDED|95.0|-0.71|-0.22|||Repeated measures ANOVA|Data was evaluated via repeated measures ANOVA after adjustment for baseline values, gender, age, and number of patients at risk at each time point.|Calculated as the between group difference in the CEA levels in the GM-CSF Group minus the CEA levels in the Control Group|Primary Analysis||-0.22|-0.71|0.0010
72336980|NCT00901511|144197527|SUPERIORITY||Median Difference (Final Values)|-12.0||||0.0059|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||Calculated as the difference at the Pre-WLL visit in the median serum CEA levels in the GM-CSF Group minus the median serum CEA levels in the Control Group|The secondary analysis includes evaluation of the difference in median serum CEA levels between groups at the Pre-WLL visit after imputation of missing data using a last observation carried forward method.||||0.0059
72336981|NCT00901511|144197527|SUPERIORITY||Median Difference (Final Values)|-3.45||||0.0382|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||Calculated as the difference at the baseline visit in the median serum CEA levels in the GM-CSF Group minus the median serum CEA levels in the Control Group|The secondary analysis includes evaluation of the difference in median serum CEA levels between groups at the baseline visit after imputation of missing data using a last observation carried forward method.||||0.0382
72336982|NCT00901511|144197527|SUPERIORITY||Median Difference (Final Values)|-3.2||||0.077|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||Calculated as the difference at the 1-month visit in the median serum CEA levels in the GM-CSF Group minus the median serum CEA levels in the Control Group|The secondary analysis includes evaluation of the difference in median serum CEA levels between groups at the 1-month visit after imputation of missing data using a last observation carried forward method.||||0.0770
72336983|NCT00901511|144197527|SUPERIORITY||Median Difference (Final Values)|-4.0||||0.04|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||Calculated as the difference at the 3-month visit in the median serum CEA levels in the GM-CSF Group minus the median serum CEA levels in the Control Group|The secondary analysis includes evaluation of the difference in median serum CEA levels between groups at the 3-month visit after imputation of missing data using a last observation carried forward method.||||0.0400
72336984|NCT00901511|144197527|SUPERIORITY||Median Difference (Final Values)|-7.9||||0.0142|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||Calculated as the difference at the 6-month visit in the median serum CEA levels in the GM-CSF Group minus the median serum CEA levels in the Control Group|The secondary analysis includes evaluation of the difference in median serum CEA levels between groups at the 6-month visit after imputation of missing data using a last observation carried forward method.||||0.0142
72336985|NCT00901511|144197527|SUPERIORITY||Median Difference (Final Values)|-6.5||||0.0071|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||Calculated as the difference at the 10-month visit in the median serum CEA levels in the GM-CSF Group minus the median serum CEA levels in the Control Group|The secondary analysis includes evaluation of the difference in median serum CEA levels between groups at the 10-month visit after imputation of missing data using a last observation carried forward method.||||0.0071
72336986|NCT00901511|144197527|SUPERIORITY||Median Difference (Final Values)|-5.6||||0.0137|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||Calculated as the difference at the 18-month visit in the median serum CEA levels in the GM-CSF Group minus the median serum CEA levels in the Control Group|The secondary analysis includes evaluation of the difference in median serum CEA levels between groups at the 18-month visit after imputation of missing data using a last observation carried forward method.||||0.0137
72336987|NCT00901511|144197527|SUPERIORITY||Median Difference (Final Values)|-3.2||||0.0315|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||Calculated as the difference at the 30-month visit in the median serum CEA levels in the GM-CSF Group minus the median serum CEA levels in the Control Group|The secondary analysis includes evaluation of the difference in median serum CEA levels between groups at the 30-month visit after imputation of missing data using a last observation carried forward method.||||0.0315
72336988|NCT00901511|144197528|SUPERIORITY||Mean Difference (Final Values)|-3689.0||||0.03|TWO_SIDED|95.0|-6972.0|-406.0|||Repeated measures ANOVA|Data was evaluated via repeated measures ANOVA after adjustment for baseline values, gender, age, and number of patients at risk at each time point.|Calculated as the between group difference in the KL-6 levels in the GM-CSF Group minus the KL-6 levels in the Control Group|Primary Analysis||-406|-6972|0.0300
72336989|NCT00901511|144197528|SUPERIORITY||Median Difference (Final Values)|-3265.0||||0.077|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||Calculated as the difference at the Pre-WLL visit in the median serum KL-6 levels in the GM-CSF Group minus the median KL-6 levels in the Control Group|The secondary analysis includes evaluation of the difference in median serum KL-6 levels between groups at the Pre-WLL visit after imputation of missing data using a last observation carried forward method.||||0.0770
72336990|NCT00901511|144197528|SUPERIORITY||Median Difference (Final Values)|-5018.0||||0.0745|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||Calculated as the difference at the baseline visit in the median serum KL-6 levels in the GM-CSF Group minus the median KL-6 levels in the Control Group|The secondary analysis includes evaluation of the difference in median serum KL-6 levels between groups at the baseline visit after imputation of missing data using a last observation carried forward method.||||0.0745
72336991|NCT00901511|144197528|SUPERIORITY||Median Difference (Final Values)|-6343.0||||0.2581|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||Calculated as the difference at the 1-month visit in the median serum KL-6 levels in the GM-CSF Group minus the median KL-6 levels in the Control Group|The secondary analysis includes evaluation of the difference in median serum KL-6 levels between groups at the 1-month visit after imputation of missing data using a last observation carried forward method.||||0.2581
72336992|NCT00901511|144197528|SUPERIORITY||Median Difference (Final Values)|-4102.0||||0.4894|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||Calculated as the difference at the 3-month visit in the median serum KL-6 levels in the GM-CSF Group minus the median KL-6 levels in the Control Group|The secondary analysis includes evaluation of the difference in median serum KL-6 levels between groups at the 3-month visit after imputation of missing data using a last observation carried forward method.||||0.4894
72336993|NCT00901511|144197528|SUPERIORITY||Median Difference (Final Values)|-6818.0|||>|0.9999|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||Calculated as the difference at the 6-month visit in the median serum KL-6 levels in the GM-CSF Group minus the median KL-6 levels in the Control Group|The secondary analysis includes evaluation of the difference in median serum KL-6 levels between groups at the 6-month visit after imputation of missing data using a last observation carried forward method.||||>0.9999
72336994|NCT00901511|144197528|SUPERIORITY||Median Difference (Final Values)|-1570.0||||0.8633|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||Calculated as the difference at the 10-month visit in the median serum KL-6 levels in the GM-CSF Group minus the median KL-6 levels in the Control Group|The secondary analysis includes evaluation of the difference in median serum KL-6 levels between groups at the 10-month visit after imputation of missing data using a last observation carried forward method.||||0.8633
72336995|NCT00901511|144197528|SUPERIORITY||Median Difference (Final Values)|-4200.0||||0.3401|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||Calculated as the difference at the 18-month visit in the median serum KL-6 levels in the GM-CSF Group minus the median KL-6 levels in the Control Group|The secondary analysis includes evaluation of the difference in median serum KL-6 levels between groups at the 18-month visit after imputation of missing data using a last observation carried forward method.||||0.3401
72336996|NCT00901511|144197528|SUPERIORITY||Median Difference (Final Values)|-4307.0||||0.2973|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||Calculated as the difference at the 30-month visit in the median serum KL-6 levels in the GM-CSF Group minus the median KL-6 levels in the Control Group|The secondary analysis includes evaluation of the difference in median serum KL-6 levels between groups at the 30-month visit after imputation of missing data using a last observation carried forward method.||||0.2973
72336997|NCT00901511|144197529|SUPERIORITY||Mean Difference (Final Values)|-0.24||||0.22|TWO_SIDED|95.0|-0.44|-0.04|||Repeated measures ANOVA||Calculated as the between group difference in the serum Cyfra21.1 levels in the GM-CSF Group minus the serum Cyfra21.1 levels in the Control Group|Primary Analysis||-0.04|-0.44|0.220
72369741|NCT04193189|144249797|SUPERIORITY||Common proportion difference|19.0|||||TWO_SIDED|97.5|10.0|27.9|||||Common SPR proportion (expressed as percentage of participants) difference (2-CpG minus 3-alum) with two-sided 97.5% Newcombe confidence interval stratified by sex at birth and diabetes status; Mantel-Haenszel weights were used.|Comparison of Group A 2-CpG and 3-alum at 8 weeks post last scheduled vaccination (Week 12 in 2-CpG, Week 32 in 3-alum)||27.9|10.0|
72369742|NCT04193189|144249797|SUPERIORITY||Common proportion difference|27.8|||||TWO_SIDED|97.5|17.7|37.2|||||Common SP proportion (expressed as percentage of participants) difference (2-CpG minus 3-alum) with two-sided 97.5% Newcombe confidence interval stratified by sex at birth and diabetes status; Mantel-Haenszel weights were used.|Comparison of Group A 2-CpG and 3-alum at 24 weeks post last scheduled vaccination (Week 28 in 2-CpG, Week 48 in 3-alum)||37.2|17.7|
72369743|NCT04193189|144249797|SUPERIORITY||Common proportion difference|32.3|||||TWO_SIDED|97.5|21.3|42.3|||||Common SPR proportion (expressed as percentage of participants) difference (2-CpG minus 3-alum) with two-sided 97.5% Newcombe confidence interval stratified by sex at birth and diabetes status; Mantel-Haenszel weights were used.|Comparison of Group A 2-CpG and 3-alum at 48 weeks post last scheduled vaccination (Week 52 in 2-CpG, Week 72 in 3-alum)||42.3|21.3|
72369744|NCT04193189|144249797|SUPERIORITY||Common proportion difference|23.8|||||TWO_SIDED|97.5|15.5|32.3|||||Common SPR proportion (expressed as percentage of participants) difference (3-CpG minus 3-alum) with two-sided 97.5% Newcombe confidence interval stratified by sex at birth and diabetes status; Mantel-Haenszel weights were used.|Comparison of Group A 3-CpG and 3-alum at 8 weeks post last scheduled vaccination (Week 32)||32.3|15.5|
72369745|NCT04193189|144249797|SUPERIORITY||Common proportion difference|32.3|||||TWO_SIDED|97.5|23.2|41.2|||||Common SPR proportion (expressed as percentage of participants) difference (3-CpG minus 3-alum) with two-sided 97.5% Newcombe confidence interval stratified by sex at birth and diabetes status; Mantel-Haenszel weights were used.|Comparison of Group A 3-CpG and 3-alum at 24 weeks post last scheduled vaccination (Week 48)||41.2|23.2|
72369746|NCT04193189|144249797|SUPERIORITY||Common proportion difference|38.8|||||TWO_SIDED|97.5|28.9|48.1|||||Common SPR proportion (expressed as percentage of participants) difference (3-CpG minus 3-alum) with two-sided 97.5% Newcombe confidence interval stratified by sex at birth and diabetes status; Mantel-Haenszel weights were used.|Comparison of Group A 3-CpG and 3-alum at 48 weeks post last scheduled vaccination (Week 72)||48.1|28.9|
72369747|NCT04193189|144249797|SUPERIORITY||Common proportion difference|10.0|||||TWO_SIDED|97.5|3.1|16.4|||||Common SPR proportion (expressed as percentage of participants) difference (3-CpG minus 2-CpG) with two-sided 97.5% Newcombe confidence interval stratified by sex at birth and diabetes status; Mantel-Haenszel weights were used.|Comparison of Group A 3-CpG and 2-CpG at 4 weeks post last scheduled vaccination (Week 28 in 3-CpG, Week 8 in 2-CpG)||16.4|3.1|
72369748|NCT04193189|144249797|SUPERIORITY||Common proportion difference|4.8|||||TWO_SIDED|97.5|-0.8|10.5|||||Common SPR proportion (expressed as percentage of participants) difference (3-CpG minus 2-CpG) with two-sided 97.5% Newcombe confidence interval stratified by sex at birth and diabetes status; Mantel-Haenszel weights were used.|Comparison of Group A 3-CpG and 2-CpG at 8 weeks post last scheduled vaccination (Week 32 in 3-CpG, Week 12 in 2-CpG)||10.5|-0.8|
72369749|NCT04193189|144249797|SUPERIORITY||Common proportion difference|4.9|||||TWO_SIDED|97.5|-0.8|11.2|||||Common SPR proportion (expressed as percentage of participants) difference (3-CpG minus 2-CpG) with two-sided 97.5% Newcombe confidence interval stratified by sex at birth and diabetes status; Mantel-Haenszel weights were used.|Comparison of Group A 3-CpG and 2-CpG at 24 weeks post last scheduled vaccination (Week 48 in 3-CpG, Week 28 in 2-CpG)||11.2|-0.8|
72369750|NCT04193189|144249797|SUPERIORITY||Common proportion difference|7.2|||||TWO_SIDED|97.5|0.7|14.2|||||Common SPR proportion (expressed as percentage of participants) difference (3-CpG minus 2-CpG) with two-sided 97.5% Newcombe confidence interval stratified by sex at birth and diabetes status; Mantel-Haenszel weights were used.|Comparison of Group A 3-CpG and 2-CpG at 48 weeks post last scheduled vaccination (Week 72 in 3-CpG, Week 52 in 2-CpG)||14.2|0.7|
72369751|NCT03229941|144249829|SUPERIORITY||Odds Ratio (OR)|0.89||||0.515|TWO_SIDED|95.0|0.62|1.27|||Chi-squared||Liberal vs. restrictive arm comparison.|||1.27|0.62|0.515
72369752|NCT03229941|144249830|SUPERIORITY||Odds Ratio (OR)|1.09||||0.587|TWO_SIDED|99.0|0.73|1.61|||Chi-squared||Liberal vs. Restrictive arm comparison|||1.61|0.73|0.587
72369753|NCT03229941|144249831|SUPERIORITY||Odds Ratio (OR)|0.57||||0.007|TWO_SIDED|99.0|0.33|0.98|||Chi-squared||Liberal vs. Restrictive arm comparison|||0.98|0.33|0.007
72369754|NCT03229941|144249832|SUPERIORITY||Odds Ratio (OR)|0.93||||0.634|TWO_SIDED|99.0|0.63|1.38|||Chi-squared||Liberal vs. Restrictive arm comparison|||1.38|0.63|0.634
72369755|NCT03229941|144249833|SUPERIORITY||Odds Ratio (OR)|0.75||||0.212|TWO_SIDED|99.0|0.41|1.37|||Chi-squared||Liberal vs. Restrictive arm comparison|||1.37|0.41|0.212
72369756|NCT03229941|144249834|SUPERIORITY|||||||0.786|||||||Wilcoxon (Mann-Whitney)|||||||0.786
72369757|NCT01027806|144249835|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||<0.001
72427667|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.19|STANDARD_ERROR_OF_MEAN|0.162||0.24|TWO_SIDED|95.0|-0.51|0.13|||MMRM|||Agitation, Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.13|-0.51|0.2400
72427668|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.11|STANDARD_ERROR_OF_MEAN|0.157||0.484|TWO_SIDED|95.0|-0.42|0.2|||MMRM|||Agitation, Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.20|-0.42|0.4840
72427669|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.04|STANDARD_ERROR_OF_MEAN|0.141||0.7768|TWO_SIDED|95.0|-0.32|0.24|||MMRM|||Agitation, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.24|-0.32|0.7768
72427670|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.04|STANDARD_ERROR_OF_MEAN|0.137||0.7713|TWO_SIDED|95.0|-0.31|0.23|||MMRM|||Agitation, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.23|-0.31|0.7713
72427671|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.28|STANDARD_ERROR_OF_MEAN|0.151||0.0716|TWO_SIDED|95.0|-0.58|0.02|||MMRM|||Agitation, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.02|-0.58|0.0716
72427672|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.12|STANDARD_ERROR_OF_MEAN|0.148||0.4317|TWO_SIDED|95.0|-0.41|0.18|||MMRM|||Agitation, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.18|-0.41|0.4317
72427673|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.162||0.2115|TWO_SIDED|95.0|-0.52|0.12|||MMRM|||Agitation, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.12|-0.52|0.2115
72427674|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.17|STANDARD_ERROR_OF_MEAN|0.158||0.2818|TWO_SIDED|95.0|-0.48|0.14|||MMRM|||Agitation, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.14|-0.48|0.2818
72427675|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.18|STANDARD_ERROR_OF_MEAN|0.14||0.2018|TWO_SIDED|95.0|-0.46|0.1|||MMRM|||Agitation, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.10|-0.46|0.2018
72427676|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.06|STANDARD_ERROR_OF_MEAN|0.137||0.6554|TWO_SIDED|95.0|-0.33|0.21|||MMRM|||Agitation, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.21|-0.33|0.6554
72427677|NCT02942004|144367030|SUPERIORITY||LS mean difference|0.12|STANDARD_ERROR_OF_MEAN|0.168||0.4754|TWO_SIDED|95.0|-0.21|0.46|||MMRM|||Agitation, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.46|-0.21|0.4754
72427678|NCT02942004|144367030|SUPERIORITY||LS mean difference|0.05|STANDARD_ERROR_OF_MEAN|0.163||0.7776|TWO_SIDED|95.0|-0.28|0.37|||MMRM|||Agitation, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.37|-0.28|0.7776
72427679|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.08|STANDARD_ERROR_OF_MEAN|0.213||0.7172|TWO_SIDED|95.0|-0.5|0.35|||MMRM|||Agitation, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.35|-0.50|0.7172
72427680|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.14|STANDARD_ERROR_OF_MEAN|0.203||0.4791|TWO_SIDED|95.0|-0.55|0.26|||MMRM|||Agitation, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.26|-0.55|0.4791
72427681|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.15|STANDARD_ERROR_OF_MEAN|0.164||0.3562|TWO_SIDED|95.0|-0.48|0.17|||MMRM|||Agitation, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.17|-0.48|0.3562
72427682|NCT02942004|144367030|SUPERIORITY||LS mean difference|0.02|STANDARD_ERROR_OF_MEAN|0.162||0.8859|TWO_SIDED|95.0|-0.3|0.34|||MMRM|||Agitation, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.34|-0.30|0.8859
72427683|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.192||0.5888|TWO_SIDED|95.0|-0.49|0.28|||MMRM|||Anxiety Psychic, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.28|-0.49|0.5888
72427684|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.16|STANDARD_ERROR_OF_MEAN|0.187||0.3992|TWO_SIDED|95.0|-0.53|0.21|||MMRM|||Anxiety Psychic, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.21|-0.53|0.3992
72427685|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.35|STANDARD_ERROR_OF_MEAN|0.227||0.1212|TWO_SIDED|95.0|-0.8|0.1|||MMRM|||Anxiety Psychic, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.10|-0.80|0.1212
72427686|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.22|STANDARD_ERROR_OF_MEAN|0.221||0.3185|TWO_SIDED|95.0|-0.66|0.22|||MMRM|||Anxiety Psychic, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.22|-0.66|0.3185
72427687|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.16|STANDARD_ERROR_OF_MEAN|0.231||0.4809|TWO_SIDED|95.0|-0.62|0.29|||MMRM|||Anxiety Psychic, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.29|-0.62|0.4809
72427688|NCT02942004|144367030|SUPERIORITY||LS mean difference|0.03|STANDARD_ERROR_OF_MEAN|0.225||0.8953|TWO_SIDED|95.0|-0.42|0.48|||MMRM|||Anxiety Psychic, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.48|-0.42|0.8953
72427689|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.13|STANDARD_ERROR_OF_MEAN|0.223||0.5616|TWO_SIDED|95.0|-0.57|0.31|||MMRM|||Anxiety Psychic, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.31|-0.57|0.5616
72427690|NCT02942004|144367030|SUPERIORITY||LS mean difference|0.04|STANDARD_ERROR_OF_MEAN|0.216||0.8571|TWO_SIDED|95.0|-0.39|0.47|||MMRM|||Anxiety Psychic, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.47|-0.39|0.8571
72336998|NCT00901511|144197529|SUPERIORITY||Mean Difference (Final Values)|-14.19|STANDARD_ERROR_OF_MEAN|6.76||0.056|TWO_SIDED|95.0|-28.8|0.42|||t-test, 2 sided||Calculated as the difference at the Pre-WLL visit in the mean serum Cyfra21.1 levels in the GM-CSF Group minus the mean serum Cyfra21.1 levels in the Control Group|•The secondary analysis includes evaluation of the difference in mean serum Cyfra21.1 levels between groups at the Pre-WLL visit after imputation of missing data using a last observation carried forward method.||0.42|-28.80|0.0560
72336999|NCT00901511|144197529|SUPERIORITY||Mean Difference (Final Values)|-4.26|STANDARD_ERROR_OF_MEAN|2.15||0.0648|TWO_SIDED|95.0|-8.8|0.29|||t-test, 2 sided||Calculated as the difference at the baseline visit in the mean serum Cyfra21.1 levels in the GM-CSF Group minus the mean serum Cyfra21.1 levels in the Control Group|The secondary analysis includes evaluation of the difference in mean serum Cyfra21.1 levels between groups at the baseline visit after imputation of missing data using a last observation carried forward method.||0.29|-8.80|0.0648
72337000|NCT00901511|144197529|SUPERIORITY||Mean Difference (Final Values)|-6.27|STANDARD_ERROR_OF_MEAN|2.36||0.0175|TWO_SIDED|95.0|-11.28|-1.25|||t-test, 2 sided||Calculated as the difference at the 1-month visit in the mean serum Cyfra21.1 levels in the GM-CSF Group minus the mean serum Cyfra21.1 levels in the Control Group|The secondary analysis includes evaluation of the difference in mean serum Cyfra21.1 levels between groups at the 1-month visit after imputation of missing data using a last observation carried forward method.||-1.25|-11.28|0.0175
72337001|NCT00901511|144197529|SUPERIORITY||Mean Difference (Final Values)|-16.81|STANDARD_ERROR_OF_MEAN|6.16||0.0148|TWO_SIDED|95.0|-29.85|-3.76|||t-test, 2 sided||Calculated as the difference at the 3-month visit in the mean serum Cyfra21.1 levels in the GM-CSF Group minus the mean serum Cyfra21.1 levels in the Control Group|The secondary analysis includes evaluation of the difference in mean serum Cyfra21.1 levels between groups at the 3-month visit after imputation of missing data using a last observation carried forward method.||-3.76|-29.85|0.0148
72337002|NCT00901511|144197529|SUPERIORITY||Mean Difference (Final Values)|-5.41|STANDARD_ERROR_OF_MEAN|1.82||0.0089|TWO_SIDED|95.0|-9.27|-1.56|||t-test, 2 sided||Calculated as the difference at the 6-month visit in the mean serum Cyfra21.1 levels in the GM-CSF Group minus the mean serum Cyfra21.1 levels in the Control Group|The secondary analysis includes evaluation of the difference in mean serum Cyfra21.1 levels between groups at the 6-month visit after imputation of missing data using a last observation carried forward method.||-1.56|-9.27|0.0089
72337003|NCT00901511|144197529|SUPERIORITY||Mean Difference (Final Values)|-5.18|STANDARD_ERROR_OF_MEAN|2.24||0.0343|TWO_SIDED|95.0|-9.92|-0.43|||t-test, 2 sided||Calculated as the difference at the 10-month visit in the mean serum Cyfra21.1 levels in the GM-CSF Group minus the mean serum Cyfra21.1 levels in the Control Group|The secondary analysis includes evaluation of the difference in mean serum Cyfra21.1 levels between groups at the 10-month visit after imputation of missing data using a last observation carried forward method.||-0.43|-9.92|0.0343
72337004|NCT00901511|144197529|SUPERIORITY||Mean Difference (Final Values)|-4.26|STANDARD_ERROR_OF_MEAN|2.33||0.0871|TWO_SIDED|95.0|-9.21|0.69|||t-test, 2 sided||Calculated as the difference at the 18-month visit in the mean serum Cyfra21.1 levels in the GM-CSF Group minus the mean serum Cyfra21.1 levels in the Control Group|The secondary analysis includes evaluation of the difference in mean serum Cyfra21.1 levels between groups at the 18-month visit after imputation of missing data using a last observation carried forward method.||0.69|-9.21|0.0871
72337005|NCT00901511|144197529|SUPERIORITY||Mean Difference (Final Values)|-3.01|STANDARD_ERROR_OF_MEAN|2.4||0.2265|TWO_SIDED|95.0|-8.09|2.06|||t-test, 2 sided||Calculated as the difference at the 30-month visit in the mean serum Cyfra21.1 levels in the GM-CSF Group minus the mean serum Cyfra21.1 levels in the Control Group|The secondary analysis includes evaluation of the difference in mean serum Cyfra21.1 levels between groups at the 30-month visit after imputation of missing data using a last observation carried forward method.||2.06|-8.09|0.2265
72337006|NCT00901511|144197530|SUPERIORITY||Median Difference (Final Values)|8.78||||0.3865|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||Calculated as the difference at the Pre-WLL visit in the median serum GMAb levels in the GM-CSF Group minus the median serum GMAb levels in the Control Group|The secondary analysis includes evaluation of the difference in median serum GMAb levels between groups at the Pre-WLL visit after imputation of missing data using a last observation carried forward method.||||0.3865
72337007|NCT00901511|144197530|SUPERIORITY||Median Difference (Final Values)|7.82||||0.1672|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||Calculated as the difference at the baseline visit in the median serum GMAb levels in the GM-CSF Group minus the median serum GMAb levels in the Control Group|The secondary analysis includes evaluation of the difference in median serum GMAb levels between groups at the baseline visit after imputation of missing data using a last observation carried forward method.||||0.1672
72337008|NCT00901511|144197530|SUPERIORITY||Median Difference (Final Values)|4.24||||0.4363|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||Calculated as the difference at the 1-month visit in the median serum GMAb levels in the GM-CSF Group minus the median serum GMAb levels in the Control Group|The secondary analysis includes evaluation of the difference in median serum GMAb levels between groups at the 1-month visit after imputation of missing data using a last observation carried forward method.||||0.4363
72337009|NCT00901511|144197530|SUPERIORITY||Median Difference (Final Values)|7.34||||0.1615|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||Calculated as the difference at the 3-month visit in the median serum GMAb levels in the GM-CSF Group minus the median serum GMAb levels in the Control Group|The secondary analysis includes evaluation of the difference in median serum GMAb levels between groups at the 3-month visit after imputation of missing data using a last observation carried forward method.||||0.1615
72337010|NCT00901511|144197530|SUPERIORITY||Median Difference (Final Values)|13.71||||0.1615|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||Calculated as the difference at the 6-month visit in the median serum GMAb levels in the GM-CSF Group minus the median serum GMAb levels in the Control Group|The secondary analysis includes evaluation of the difference in median serum GMAb levels between groups at the 6-month visit after imputation of missing data using a last observation carried forward method.||||0.1615
72337011|NCT00901511|144197530|SUPERIORITY||Median Difference (Final Values)|11.1||||0.3865|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||Calculated as the difference at the 10-month visit in the median serum GMAb levels in the GM-CSF Group minus the median serum GMAb levels in the Control Group|The secondary analysis includes evaluation of the difference in median serum GMAb levels between groups at the 10-month visit after imputation of missing data using a last observation carried forward method.||||0.3865
72337012|NCT00901511|144197530|SUPERIORITY||Median Difference (Final Values)|5.4||||0.6475|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||• Calculated as the difference at the 18-month visit in the median serum GMAb levels in the GM-CSF Group minus the median serum GMAb levels in the Control Group|The secondary analysis includes evaluation of the difference in median serum GMAb levels between groups at the 18-month visit after imputation of missing data using a last observation carried forward method.||||0.6475
72337013|NCT00901511|144197530|SUPERIORITY||Median Difference (Final Values)|-7.0||||0.6481|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||Calculated as the difference at the 30-month visit in the median serum GMAb levels in the GM-CSF Group minus the median serum GMAb levels in the Control Group|The secondary analysis includes evaluation of the difference in median serum GMAb levels between groups at the 30-month visit after imputation of missing data using a last observation carried forward method.||||0.6481
72337014|NCT00901511|144197531|SUPERIORITY||Mean Difference (Final Values)|-1.55|STANDARD_ERROR_OF_MEAN|0.78||0.0582|TWO_SIDED|95.0|-3.17|0.06|||t-test, 2 sided||Calculated as the difference at the Pre-WLL visit in the mean WBC count in the GM-CSF Group minus the mean WBC count in the Control Group|The secondary analysis includes evaluation of the difference in mean WBC counts between groups at the Pre-WLL visit after imputation of missing data using a last observation carried forward method.||0.06|-3.17|0.0582
72337015|NCT00901511|144197531|SUPERIORITY||Mean Difference (Final Values)|1.15|STANDARD_ERROR_OF_MEAN|1.09||0.3068|TWO_SIDED|95.0|-1.17|3.48|||t-test, 2 sided||Calculated as the difference at the baseline visit in the mean WBC count in the GM-CSF Group minus the mean WBC count in the Control Group|The secondary analysis includes evaluation of the difference in mean WBC counts between groups at the baseline visit after imputation of missing data using a last observation carried forward method.||3.48|-1.17|0.3068
72337016|NCT00901511|144197531|SUPERIORITY||Mean Difference (Final Values)|-0.44|STANDARD_ERROR_OF_MEAN|0.75||0.5647|TWO_SIDED|95.0|-2.04|1.15|||t-test, 2 sided||Calculated as the difference at the 1-month visit in the mean WBC count in the GM-CSF Group minus the mean WBC count in the Control Group|The secondary analysis includes evaluation of the difference in mean WBC counts between groups at the 1-month visit after imputation of missing data using a last observation carried forward method.||1.15|-2.04|0.5647
72337017|NCT00901511|144197531|SUPERIORITY||Mean Difference (Final Values)|-0.86|STANDARD_ERROR_OF_MEAN|0.59||0.1669|TWO_SIDED|95.0|-2.11|0.4|||t-test, 2 sided||Calculated as the difference at the 3-month visit in the mean WBC count in the GM-CSF Group minus the mean WBC count in the Control Group|The secondary analysis includes evaluation of the difference in mean WBC counts between groups at the 3-month visit after imputation of missing data using a last observation carried forward method.||0.40|-2.11|0.1669
72337018|NCT00901511|144197531|SUPERIORITY||Mean Difference (Final Values)|-0.53|STANDARD_DEVIATION|0.69||0.453|TWO_SIDED|95.0|-1.99|0.93|||t-test, 2 sided||Calculated as the difference at the 6-month visit in the mean WBC count in the GM-CSF Group minus the mean WBC count in the Control Group|The secondary analysis includes evaluation of the difference in mean WBC counts between groups at the 6-month visit after imputation of missing data using a last observation carried forward method.||0.93|-1.99|0.4530
72427691|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.63|STANDARD_ERROR_OF_MEAN|0.213||0.0037|TWO_SIDED|95.0|-1.05|-0.21|||MMRM|||Anxiety Psychic, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.21|-1.05|0.0037
72337019|NCT00901511|144197531|SUPERIORITY||Mean Difference (Final Values)|-0.54|STANDARD_ERROR_OF_MEAN|0.71||0.4594|TWO_SIDED|95.0|-2.04|0.97|||t-test, 2 sided||Calculated as the difference at the 10-month visit in the mean WBC count in the GM-CSF Group minus the mean WBC count in the Control Group|The secondary analysis includes evaluation of the difference in mean WBC counts between groups at the 10-month visit after imputation of missing data using a last observation carried forward method.||0.97|-2.04|0.4594
72337020|NCT00901511|144197531|SUPERIORITY||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.62||0.6302|TWO_SIDED|95.0|-1.61|1.0|||t-test, 2 sided||Calculated as the difference at the 18-month visit in the mean WBC count in the GM-CSF Group minus the mean WBC count in the Control Group|The secondary analysis includes evaluation of the difference in mean WBC counts between groups at the 18-month visit after imputation of missing data using a last observation carried forward method.||1.00|-1.61|0.6302
72337021|NCT00901511|144197531|SUPERIORITY||Mean Difference (Final Values)|-0.72|STANDARD_ERROR_OF_MEAN|0.72||0.33|TWO_SIDED|95.0|-2.24|0.8|||t-test, 2 sided||Calculated as the difference at the 30-month visit in the mean WBC count in the GM-CSF Group minus the mean WBC count in the Control Group|The secondary analysis includes evaluation of the difference in mean WBC counts between groups at the 30-month visit after imputation of missing data using a last observation carried forward method.||0.80|-2.24|0.3300
72337022|NCT00901511|144197532|SUPERIORITY||Mean Difference (Final Values)|-53.72|STANDARD_ERROR_OF_MEAN|38.79||0.1864|TWO_SIDED|95.0|-136.4|28.96|||t-test, 2 sided||Calculated as the difference at the Pre-WLL visit in the mean platelet count in the GM-CSF Group minus the mean platelet count in the Control Group|The secondary analysis includes evaluation of the difference in mean platelet counts between groups at the Pre-WLL visit after imputation of missing data using a last observation carried forward method.||28.96|-136.4|0.1864
72337023|NCT00901511|144197532|SUPERIORITY||Mean Difference (Final Values)|-21.17|STANDARD_ERROR_OF_MEAN|46.3||0.6541|TWO_SIDED|95.0|-119.8|77.51|||t-test, 2 sided||Calculated as the difference at the baseline visit in the mean platelet count in the GM-CSF Group minus the mean platelet count in the Control Group|The secondary analysis includes evaluation of the difference in mean platelet counts between groups at the baseline visit after imputation of missing data using a last observation carried forward method.||77.51|-119.8|0.6541
72337024|NCT00901511|144197532|SUPERIORITY||Mean Difference (Final Values)|-18.78|STANDARD_ERROR_OF_MEAN|24.58||0.456|TWO_SIDED|95.0|-70.89|33.33|||t-test, 2 sided||Calculated as the difference at the 1-month visit in the mean platelet count in the GM-CSF Group minus the mean platelet count in the Control Group|The secondary analysis includes evaluation of the difference in mean platelet counts between groups at the 1-month visit after imputation of missing data using a last observation carried forward method.||33.33|-70.89|0.4560
72337025|NCT00901511|144197532|SUPERIORITY||Mean Difference (Final Values)|-28.44|STANDARD_ERROR_OF_MEAN|30.98||0.3721|TWO_SIDED|95.0|-94.12|37.23|||t-test, 2 sided||Calculated as the difference at the 3-month visit in the mean platelet count in the GM-CSF Group minus the mean platelet count in the Control Group|The secondary analysis includes evaluation of the difference in mean platelet counts between groups at the 3-month visit after imputation of missing data using a last observation carried forward method.||37.23|-94.12|0.3721
72337026|NCT00901511|144197532|SUPERIORITY||Mean Difference (Final Values)|-28.78|STANDARD_ERROR_OF_MEAN|20.58||0.1812|TWO_SIDED|95.0|-72.41|14.86|||t-test, 2 sided||Calculated as the difference at the 6-month visit in the mean platelet count in the GM-CSF Group minus the mean platelet count in the Control Group|The secondary analysis includes evaluation of the difference in mean platelet counts between groups at the 6-month visit after imputation of missing data using a last observation carried forward method.||14.86|-72.41|0.1812
72337027|NCT00901511|144197532|SUPERIORITY||Mean Difference (Final Values)|-26.11|STANDARD_ERROR_OF_MEAN|23.38||0.2805|TWO_SIDED|95.0|-75.67|23.44|||t-test, 2 sided||Calculated as the difference at the 10-month visit in the mean platelet count in the GM-CSF Group minus the mean platelet count in the Control Group|The secondary analysis includes evaluation of the difference in mean platelet counts between groups at the 10-month visit after imputation of missing data using a last observation carried forward method.||23.44|-75.67|0.2805
72337028|NCT00901511|144197532|SUPERIORITY||Mean Difference (Final Values)|-27.33|STANDARD_ERROR_OF_MEAN|22.75||0.247|TWO_SIDED|95.0|-75.56|20.89|||t-test, 2 sided||Calculated as the difference at the 18-month visit in the mean platelet count in the GM-CSF Group minus the mean platelet count in the Control Group|The secondary analysis includes evaluation of the difference in mean platelet counts between groups at the 18-month visit after imputation of missing data using a last observation carried forward method.||20.89|-75.56|0.2470
72337029|NCT00901511|144197532|SUPERIORITY||Mean Difference (Final Values)|-31.0|STANDARD_ERROR_OF_MEAN|23.57||0.207|TWO_SIDED|95.0|-80.97|18.97|||t-test, 2 sided||Calculated as the difference at the 30-month visit in the mean platelet count in the GM-CSF Group minus the mean platelet count in the Control Group|The secondary analysis includes evaluation of the difference in mean platelet counts between groups at the 30-month visit after imputation of missing data using a last observation carried forward method.||18.97|-80.97|0.2070
72337030|NCT00901511|144197533|SUPERIORITY||Mean Difference (Final Values)|4.72||||0.149|TWO_SIDED|95.0|-1.88|11.33|||Repeated measures ANOVA|Data was evaluated via repeated measures ANOVA after adjustment for baseline values, gender, age, and number of patients at risk at each time point.|Calculated as the difference in the mean value of the SF-36 General Health Score in the GM-CSF Group minus the Control Group|Primary analysis||11.33|-1.88|0.1490
72337031|NCT00901511|144197533|SUPERIORITY||Mean Difference (Final Values)|-4.31|STANDARD_ERROR_OF_MEAN|12.07||0.7263|TWO_SIDED|95.0|-30.04|21.43|||t-test, 2 sided||Calculated as the difference at the Pre-WLL visit in the mean SF-36 General Health Score in the GM-CSF Group minus the mean SF-36 General Health Score in the Control Group|The secondary analysis includes evaluation of the difference in mean SF-36 General Health Score between groups at the Pre-WLL visit after imputation of missing data using a last observation carried forward method.||21.43|-30.04|0.7263
72337032|NCT00901511|144197533|SUPERIORITY||Mean Difference (Final Values)|8.33|STANDARD_ERROR_OF_MEAN|8.29||0.3298|TWO_SIDED|95.0|-9.24|25.91|||t-test, 2 sided||Calculated as the difference at the 1-month visit in the mean SF-36 General Health Score in the GM-CSF Group minus the mean SF-36 General Health Score in the Control Group|The secondary analysis includes evaluation of the difference in SF-36 General Health Score between groups at the 1-month visit after imputation of missing data using a last observation carried forward method.||25.91|-9.24|0.3298
72337033|NCT00901511|144197533|SUPERIORITY||Mean Difference (Final Values)|13.89|STANDARD_ERROR_OF_MEAN|6.48||0.0478|TWO_SIDED|95.0|-0.15|27.62|||t-test, 2 sided||Calculated as the difference at the 3-month visit in the mean SF-36 General Health Score in the GM-CSF Group minus the mean SF-36 General Health Score in the Control Group|The secondary analysis includes evaluation of the difference in SF-36 General Health Score between groups at the 3-month visit after imputation of missing data using a last observation carried forward method.||27.62|-0.15|0.0478
72337034|NCT00901511|144197533|SUPERIORITY||Mean Difference (Final Values)|17.78|STANDARD_ERROR_OF_MEAN|7.37||0.0281|TWO_SIDED|95.0|2.16|33.39|||t-test, 2 sided||Calculated as the difference at the 6-month visit in the mean SF-36 General Health Score in the GM-CSF Group minus the mean SF-36 General Health Score in the Control Group|The secondary analysis includes evaluation of the difference in mean SF-36 General Health Score between groups at the 6-month visit after imputation of missing data using a last observation carried forward method.||33.39|2.16|0.0281
72337035|NCT00901511|144197533|SUPERIORITY||Mean Difference (Final Values)|11.67|STANDARD_ERROR_OF_MEAN|10.07||0.2634|TWO_SIDED|95.0|-9.67|33.0|||t-test, 2 sided||Calculated as the difference at the 10-month visit in the mean SF-36 General Health Score in the GM-CSF Group minus the mean SF-36 General Health Score in the Control Group|The secondary analysis includes evaluation of the difference in mean SF-36 General Health Score between groups at the 10-month visit after imputation of missing data using a last observation carried forward method.||33.00|-9.67|0.2634
72369867|NCT04881942|144250168|EQUIVALENCE|Null Hypothesis: Mean Puff Count is equal to 0 Alternative Hypothesis: Mean Puff Count is not equal to 0|Mean Difference (Final Values)|241.32|||<|0.0001|TWO_SIDED|95.0|176.99|305.64|||ANCOVA||LSM calculated from mixed models. Each model includes fixed effect terms for product, period and sequence.|Null Hypothesis: Mean Puff Count is equal to 0 Alternative Hypothesis: Mean Puff Count is not equal to 0||305.64|176.99|<.0001
72369868|NCT04881942|144250168|EQUIVALENCE|Null Hypothesis: Mean Puff Count is equal to 0 Alternative Hypothesis: Mean Puff Count is not equal to 0|Mean Difference (Final Values)|248.22|||<|0.0001|TWO_SIDED|95.0|184.01|312.43|||ANCOVA||LSM calculated from mixed models. Each model includes fixed effect terms for product, period and sequence.|Null Hypothesis: Mean Puff Count is equal to 0 Alternative Hypothesis: Mean Puff Count is not equal to 0||312.43|184.01|<.0001
72337036|NCT00901511|144197533|SUPERIORITY||Mean Difference (Final Values)|10.0|STANDARD_ERROR_OF_MEAN|10.49||0.3548|TWO_SIDED|95.0|-12.24|32.24|||t-test, 2 sided||Calculated as the difference at the 18-month visit in the mean SF-36 General Health Score in the GM-CSF Group minus the mean SF-36 General Health Score in the Control Group|The secondary analysis includes evaluation of the difference in mean SF-36 General Health Score between groups at the 18-month visit after imputation of missing data using a last observation carried forward method.||32.24|-12.24|0.3548
72337037|NCT00901511|144197533|SUPERIORITY||Mean Difference (Final Values)|16.67|STANDARD_ERROR_OF_MEAN|9.68||0.1043|TWO_SIDED|95.0|-3.85|37.18|||t-test, 2 sided||Calculated as the difference at the 30-month visit in the mean SF-36 General Health Score in the GM-CSF Group minus the mean SF-36 General Health Score in the Control Group|The secondary analysis includes evaluation of the difference in mean SF-36 General Health Score between groups at the 30-month visit after imputation of missing data using a last observation carried forward method.||37.18|-3.85|0.1043
72337038|NCT02880514|144197580|SUPERIORITY|||||||0.0391||||||P-value not adjusted for multiplicity.|McNemar|McNemar's exact binomial test was employed to obtain the two-sided p-value at alpha level of 0.05.||||||0.0391
72337039|NCT02880514|144197581|SUPERIORITY|||||||0.68|||||||t-test, 2 sided|||||||0.68
72337040|NCT02436668|144197582|SUPERIORITY||Hazard Ratio (HR)|1.525|||<|0.0001|TWO_SIDED|95.0|1.241|1.873||P-value is from log-rank test stratified by the three randomization stratification factors \[KPS (70-80 vs. 90-100), liver metastasis (present vs. absent), and age (≤65 vs. \>65)\].|Log Rank|||The treatment effect was tested with an stratified log rank test. Hazard ratio is estimated using Cox regression model stratified by the three randomization stratification factors \[KPS (70 80 vs. 90-100), liver metastasis (present vs. absent), and age (≤65 vs. \>65)\] and with treatment as the only covariate.||1.873|1.241|<0.0001
72337041|NCT02436668|144197583|SUPERIORITY|P-value is based on log-rank test stratified by the three randomization stratification factors \[KPS (70-80 vs. 90-100), liver metastasis (present vs. absent), and age (≤65 vs. \>65)\].|Hazard Ratio (HR)|1.109||||0.3225|TWO_SIDED|95.0|0.903|1.363|||Log Rank|||The treatment effect was tested with an stratified log rank test. Hazard ratio is estimated using Cox regression model stratified by the three randomization stratification factors \[KPS (70 80 vs. 90-100), liver metastasis (present vs. absent), and age (≤65 vs. \>65)\] and with treatment as the only covariate.||1.363|0.903|0.3225
72337042|NCT02436668|144197585|SUPERIORITY||Risk Ratio (RR)|0.695||||0.0058|TWO_SIDED|95.0|0.535|0.903|||Cochran-Mantel-Haenszel|||For rate ratio, numerator is Ibr+Gem/Abr arm and denominator is Pbo + Gem/Abr arm. P-value for rate ratio is based on Cochran-Mantel-Haenszel (CMH) test adjusted for the three randomization stratification factors. Two-sided 95% confidence interval for rate ratio is based on Mantel-Haenszel method.||0.903|0.535|0.0058
72337043|NCT02436668|144197587|SUPERIORITY||Risk Ratio (RR)|0.85||||0.0488|TWO_SIDED|95.0|0.722|1.0|||Cochran-Mantel-Haenszel||This 0.85 (0.722 to 1.0) with CI is referring to risk ratio not proportional/percentage of patients.|For rate ratio, numerator is Ibr+Gem/Abr arm and denominator is Pbo+Gem/Abr arm. P-value for rate ratio is based on Cochran-Mantel-Haenszel (CMH) test adjusted for the three randomization stratification factors. Two-sided 95% confidence interval for rate ratio is based on Mantel-Haenszel method.||1.0|0.722|0.0488
72337044|NCT02436668|144197588|SUPERIORITY||Hazard Ratio (HR)|1.265||||0.0782|TWO_SIDED|95.0|0.975|1.642||P-value is from log-rank test stratified by the three randomization stratification factors.|Log Rank|||\[1\] Hazard ratio is based on a Cox proportional hazards model stratified by the three randomization stratification factors for time until definitive deterioration (TUDD1), a hazard ratio \< 1 favors Ibr + Gem/Abr. TUDD1 is defined as the time interval between randomization and the first occurrence of a decrease in score by \>= 10 points without any further improvement in score by \>= 10 points or any further available QoL data due to dropout after deterioration.||1.642|0.975|0.0782
72337045|NCT02436668|144197589|SUPERIORITY|||||||0.3343|||||||Chi-squared|||"For rate of VTEs, denominator is number of subjects in the Intent-to-Treat population and numerator is number of Intent-to-Treat subjects with at least one VTE observed any time on study. Confidence interval for rate of VTEs is based on Clopper-Pearson method.~\[1\] P value is based on Chi-square test."||||0.3343
72337046|NCT02230761|144197595|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED||||||Chi-squared|||||||0.020
72337047|NCT02230761|144197596|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED||||||t-test, 2 sided|||||||0.001
72337048|NCT02230761|144197597|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED||||||t-test, 2 sided|||||||0.002
72337049|NCT02210221|144197598|NON_INFERIORITY|non-inferiority margin = 0|||||<|0.0001||||||No corrections for multiple comparisons were done|ANOVA|||null hypothesis: no difference between ER stratum, Admission stratum and ICU stratum in 6-month mortality||||<0.0001
72337050|NCT02210221|144197598|OTHER||observed to expected ratio|0.7|||||TWO_SIDED|95.0|0.62|0.76|||||numerator: 6-month mortality observed denominator: 6-month mortality expected 95% CIs estimated according to a Poisson distribution|||0.76|0.62|
72337051|NCT02210221|144197599|NON_INFERIORITY|non-inferiority margin = 0|||||<|0.0001||||||No corrections for multiple comparisons were done|ANOVA|||null hypothesis: no difference between ER stratum, Admission stratum and ICU stratum in SF-12v2 mental component summary||||<0.0001
72337052|NCT02210221|144197599|NON_INFERIORITY|non-inferiority margin = 0|||||<|0.0001||||||No corrections for multiple comparisons were done|ANOVA|||null hypothesis: no difference between ER stratum, Admission stratum and ICU stratum in SF-12v2 physical component summary||||<0.0001
72337053|NCT02210221|144197600|NON_INFERIORITY|non-inferiority margin = 0|||||<|0.0001||||||No corrections for multiple comparisons were done|ANOVA|||null hypothesis: no difference between ER stratum, Admission stratum and ICU stratum in Qolibri Overall Scale||||<0.0001
72337054|NCT02210221|144197601|NON_INFERIORITY|non-inferiority margin = 0|||||<|0.0001||||||No correlations for multiple comparisons were done|ANOVA|||null hypothesis: no difference between ER stratum, Admission stratum and ICU stratum||||<0.0001
72337055|NCT02210221|144197602|NON_INFERIORITY|non-inferiority margin = 0|||||<|0.0001||||||No correlations for multiple comparisons were done|ANOVA|||null hypothesis: no difference between ER stratum, Admission stratum and ICU stratum||||<0.0001
72337056|NCT02210221|144197603|NON_INFERIORITY|non-inferiority margin = 0|||||<|0.0001||||||No correlations for multiple comparisons were done|ANOVA|||null hypothesis: no difference between ER stratum, Admission stratum and ICU stratum||||<0.0001
72337057|NCT02210221|144197604|NON_INFERIORITY|non-inferiority margin = 0|||||<|0.0001|||||||ANOVA|||null hypothesis: no difference between ER stratum, Admission stratum and ICU stratum||||<0.0001
72337058|NCT02210221|144197605|NON_INFERIORITY|non-inferiority margin = 0||||||0.169|||||||ANOVA|||null hypothesis: no difference between ER stratum, Admission stratum and ICU stratum||||0.169
72337059|NCT02210221|144197606|NON_INFERIORITY|non-inferiority margin = 0|||||<|0.0001|||||||Fisher Exact|||null hypothesis: no difference between ER stratum, Admission stratum and ICU stratum||||<0.0001
72337060|NCT02210221|144197607|NON_INFERIORITY|non-inferiority margin = 0|||||<|0.0001|||||||ANOVA|||null hypothesis: no difference between ER stratum, Admission stratum and ICU stratum||||<0.0001
72337061|NCT02210221|144197608|NON_INFERIORITY|non-inferiority margin = 0|||||<|0.0001|||||||ANOVA|||null hypothesis: no difference between ER stratum, Admission stratum and ICU stratum||||<0.0001
72337062|NCT02210221|144197609|NON_INFERIORITY|non-inferiority margin = 0||||||0.637|||||||ANOVA|||null hypothesis: no difference between ER stratum, Admission stratum and ICU stratum||||0.637
72337063|NCT02210221|144197610|NON_INFERIORITY|non-inferiority margin = 0|||||<|0.0001|||||||ANOVA|||null hypothesis: no difference between ER stratum, Admission stratum and ICU stratum||||<0.0001
72337064|NCT02210221|144197611|NON_INFERIORITY|non-inferiority margin = 0||||||0.48|||||||ANOVA|||null hypothesis: no difference between ER stratum, Admission stratum and ICU stratum||||0.480
72337065|NCT02210221|144197612|NON_INFERIORITY|non-inferiority margin = 0|||||<|0.0001|||||||ANOVA|||null hypothesis: no difference between ER stratum, Admission stratum and ICU stratum||||<0.0001
72337066|NCT02210221|144197613|NON_INFERIORITY|non-inferiority margin = 0||||||0.024|||||||ANOVA|||null hypothesis: no difference between ER stratum, Admission stratum and ICU stratum||||0.024
72337067|NCT02210221|144197614|NON_INFERIORITY|non-inferiority margin = 0||||||0.064|||||||ANOVA|||null hypothesis: no difference between ER stratum, Admission stratum and ICU stratum||||0.064
72337068|NCT02210221|144197615|NON_INFERIORITY|non-inferiority margin = 0|||||<|0.0001|||||||ANOVA|||null hypothesis: no difference between ER stratum, Admission stratum and ICU stratum||||<0.0001
72337069|NCT00405964|144197620|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||Determined for site. P-value of \<.001 for treatment as well.|ANOVA|||||||<.001
72337070|NCT00405964|144197621|SUPERIORITY_OR_OTHER_LEGACY|||||||0.035||95.0||||Determined for site. Treatment p-value \<.001|ANOVA|||||||0.035
72337071|NCT00405964|144197622|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||Same p-value for treatment and site.|ANOVA|||||||<.001
72427692|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.43|STANDARD_ERROR_OF_MEAN|0.206||0.0386|TWO_SIDED|95.0|-0.84|-0.02|||MMRM|||Anxiety Psychic, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.02|-0.84|0.0386
72337072|NCT02863523|144197632|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
72337073|NCT02863523|144197633|SUPERIORITY||||||<|0.03|||||||t-test, 2 sided|||||||<0.03
72337074|NCT02863523|144197634|SUPERIORITY||||||<|0.01|||||||t-test, 2 sided|||||||<0.01
72337075|NCT00823212|144197639|NON_INFERIORITY_OR_EQUIVALENCE|A 2-group Farrington-Manning test was used to test the 1-sided hypothesis of non-inferiority in differences with a non-inferiority margin of 3.5%. A p value \<0.05 would indicate non-inferiority and correspond to the upper limit of the 1-sided 95% confidence interval of the difference not exceeding 3.5%.|Difference in percent of participants|0.5||||0.001|ONE_SIDED|95.0||2.13|||Farrington-Manning test||The standard error for the difference was estimated according to the Farrington-Manning test.|Study had 89% statistical power to demonstrate non-inferiority for target lesion failure (TLF, accounting for an expected 1-year attrition rate of 5%), assuming a 1-year TLF rate of 5.5% for both stents.||2.13||0.001
72337076|NCT00496197|144197678|SUPERIORITY_OR_OTHER||percentage of participants|83.7|||||TWO_SIDED|95.0|78.7|88.8|||||95% Confidence interval based on normal approximation to the binomial. Percentages based on the number of participants in analysis.|Global response of Success (cure or improvement) at EOT||88.8|78.7|
72337077|NCT00496197|144197679|SUPERIORITY_OR_OTHER||percentage of participants|93.0|||||TWO_SIDED|95.0|89.4|96.7|||||95% Confidence interval based on normal approximation to the binomial. Percentages based on the number of participants in analysis.|Clinical response of Success (cure or improvement) at EOT||96.7|89.4|
72337078|NCT00496197|144197680|SUPERIORITY_OR_OTHER||percentage of participants|95.3|||||TWO_SIDED|95.0|92.3|98.3|||||95% Confidence interval based on normal approximation to the binomial. Percentages based on the number of participants in analysis.|Microbiological response of Success (eradication or presumed eradication) at EOT||98.3|92.3|
72337079|NCT00496197|144197681|SUPERIORITY_OR_OTHER||percentage of participants|88.5|||||TWO_SIDED|95.0|84.4|92.6|||||95% Confidence interval based on normal approximation to the binomial. Percentages based on the number of participants in analysis.|Global response of Success (cure or improvement) at EOIV||92.6|84.4|
72337080|NCT00496197|144197682|SUPERIORITY_OR_OTHER||percentage of participants|93.1|||||TWO_SIDED|95.0|89.8|96.4|||||95% Confidence interval based on normal approximation to the binomial. Percentages based on the number of participants in analysis.|Clinical response of Success (cure or improvement) at EOIV||96.4|89.8|
72337081|NCT00496197|144197683|SUPERIORITY_OR_OTHER||percentage of participants|92.6|||||TWO_SIDED|95.0|89.3|95.9|||||95% Confidence interval based on normal approximation to the binomial. Percentages based on the number of participants in analysis.|Microbiological response of Success (eradication or presumed eradication) at EOIV||95.9|89.3|
72337082|NCT00496197|144197684|SUPERIORITY_OR_OTHER||percentage of participants|76.3|||||TWO_SIDED|95.0|70.3|82.3|||||95% Confidence interval based on normal approximation to the binomial. Percentages based on the number of participants in analysis.|Global response of Success (cure or improvement) at Week 2 Follow-up||82.3|70.3|
72337083|NCT00496197|144197685|SUPERIORITY_OR_OTHER||percentage of participants|94.8|||||TWO_SIDED|95.0|91.5|98.1|||||95% Confidence interval based on normal approximation to the binomial. Percentages based on the number of participants in analysis.|Clinical response of Success (cure or improvement) at Week 2 Follow-up||98.1|91.5|
72337084|NCT00496197|144197686|SUPERIORITY_OR_OTHER||percentage of participants|95.4|||||TWO_SIDED|95.0|92.2|98.5|||||95% Confidence interval based on normal approximation to the binomial. Percentages based on the number of participants in analysis.|Microbiological response of Success (eradication or presumed eradication) at Week 2 Follow-up||98.5|92.2|
72427693|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.63|STANDARD_ERROR_OF_MEAN|0.216||0.0044|TWO_SIDED|95.0|-1.05|-0.2|||MMRM|||Anxiety Psychic, Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.20|-1.05|0.0044
72427694|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.04|STANDARD_ERROR_OF_MEAN|0.208||0.8308|TWO_SIDED|95.0|-0.46|0.37|||MMRM|||Anxiety Psychic, Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.37|-0.46|0.8308
72337085|NCT00496197|144197687|SUPERIORITY_OR_OTHER||percentage of participants|70.1|||||TWO_SIDED|95.0|63.5|76.6|||||95% Confidence interval based on normal approximation to the binomial. Percentages based on the number of participants in analysis.|Global response of Success (cure or improvement) at Week 6 Follow-up (EOS)||76.6|63.5|
72337086|NCT00496197|144197688|SUPERIORITY_OR_OTHER||percentage of participants|93.6|||||TWO_SIDED|95.0|89.7|97.4|||||95% Confidence interval based on normal approximation to the binomial. Percentages based on the number of participants in analysis.|Clinical response of Success (cure or improvement) at Week 6 Follow-up (EOS)||97.4|89.7|
72337087|NCT00496197|144197689|SUPERIORITY_OR_OTHER||percentage of participants|93.6|||||TWO_SIDED|95.0|89.7|97.4|||||95% Confidence interval based on normal approximation to the binomial. Percentages based on the number of participants in analysis.|Microbiological response of Success (eradication or presumed eradication) at Week 6 Follow-up (EOS)||97.4|89.7|
72337088|NCT00496197|144197690|SUPERIORITY_OR_OTHER||percentage of participants|82.5|||||TWO_SIDED|95.0|75.7|89.3|||||95% Confidence interval based on normal approximation to the binomial. Percentages based on the number of participants in analysis.|Global response of Success (cure or improvement) at EOT||89.3|75.7|
72337089|NCT00496197|144197691|SUPERIORITY_OR_OTHER||percentage of participants|85.6|||||TWO_SIDED|95.0|79.8|91.4|||||95% Confidence interval based on normal approximation to the binomial. Percentages based on the number of participants in analysis.|Global response of Success (cure or improvement) at EOIV||91.4|79.8|
72337090|NCT00496197|144197692|SUPERIORITY_OR_OTHER||percentage of participants|76.7|||||TWO_SIDED|95.0|69.0|84.4|||||95% Confidence interval based on normal approximation to the binomial. Percentages based on the number of participants in analysis.|Global response of Success (cure or improvement) at Week 2 Follow-up||84.4|69.0|
72337091|NCT00496197|144197693|SUPERIORITY_OR_OTHER||percentage of participants|67.6|||||TWO_SIDED|95.0|58.9|76.3|||||95% Confidence interval based on normal approximation to the binomial. Percentages based on the number of participants in analysis.|Global response of Success (cure or improvement) at Week 6 Follow-up (EOS)||76.3|58.9|
72337092|NCT01344538|144197702|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
72337093|NCT00929773|144197728|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Fisher Exact|||||||<0.0001
72337094|NCT00929773|144197729|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||||||<.0001
72337095|NCT00929773|144197730|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||||||<0.0001
72337096|NCT00929773|144197731|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||||||<0.0001
72337097|NCT00929773|144197732|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||||||<0.0001
72337098|NCT00929773|144197733|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||||||<0.0001
72337099|NCT02583230|144197754|SUPERIORITY|||||||0.0005|||||||Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was used to evaluate the change in PHQ-9 total scores over the eight-week study period.||||||.0005
72337100|NCT02583230|144197755|SUPERIORITY|||||||0.0008|||||||Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was used to evaluate the change in QIDS total scores over the eight-week study period.||||||.0008
72337101|NCT02685748|144197810|OTHER||Mean Difference (Final Values)|-0.077|STANDARD_ERROR_OF_MEAN|0.444||0.863|TWO_SIDED|95.0|-0.969|0.815|||t-test, 2 sided|||||0.815|-0.969|0.863
72337102|NCT02685748|144197811|OTHER|T test for independent samples|Mean Difference (Final Values)|3.616|STANDARD_ERROR_OF_MEAN|2.364||0.133|TWO_SIDED|95.0|-1.147|8.379|||t-test, 2 sided|||||8.379|-1.147|0.133
72337103|NCT02685748|144197812|OTHER||Mean Difference (Final Values)|0.114|STANDARD_ERROR_OF_MEAN|0.43||1.607|TWO_SIDED|95.0|-1.1553|0.172|||t-test, 2 sided|||||0.172|-1.1553|1.607
72337104|NCT02685748|144197813|OTHER||Mean Difference (Final Values)|-1.282|STANDARD_ERROR_OF_MEAN|1.754||0.468|TWO_SIDED|95.0|-4.807|2.241|||t-test, 2 sided|||||2.241|-4.807|0.468
72337105|NCT02685748|144197814|OTHER||Mean Difference (Final Values)|-0.051|STANDARD_ERROR_OF_MEAN|0.406||0.899|TWO_SIDED|95.0|-0.869|0.765|||t-test, 2 sided|||||0.765|-0.869|0.899
72337106|NCT02685748|144197815|OTHER||Mean Difference (Final Values)|7.05|STANDARD_DEVIATION|6.797||0.305|TWO_SIDED|95.0|-6.602|20.703|||t-test, 2 sided|||||20.703|-6.602|0.305
72337107|NCT02685748|144197816|OTHER||Mean Difference (Final Values)|160.298|STANDARD_ERROR_OF_MEAN|159.525||0.32|TWO_SIDED|95.0|-160.118|480.714|||t-test, 2 sided|||||480.714|-160.118|0.320
72337108|NCT02685748|144197817|OTHER||Mean Difference (Final Values)|-1.495|STANDARD_ERROR_OF_MEAN|3.558||0.676|TWO_SIDED|95.0|-8.642|5.651|||t-test, 2 sided|||||5.651|-8.642|0.676
72337109|NCT00328653|144197824|SUPERIORITY|Comparisons of NOVA22007 0.05% to vehicle|M-H Chi-square|1.2187||||0.2699|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.2699
72337110|NCT00328653|144197824|SUPERIORITY|Comparisons of NOVA22007 0.1% to vehicle|M-H Chi-square|1.2359||||0.2719|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.2719
72337111|NCT00328653|144197827|SUPERIORITY|Comparisons of NOVA22007 0.05% to vehicle|M-H-Chi-square|4.2925||||0.0386|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.0386
72337112|NCT00328653|144197827|SUPERIORITY|Comparisons of NOVA22007 0.1% to vehicle|M-H-Chi-square|5.3007||||0.0208|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.0208
72337113|NCT03500172|144197828|SUPERIORITY|||||||0.455||||||Threshold for significance: 0.05|Two sample test of proportions|||||||0.455
72337114|NCT03500172|144197829|SUPERIORITY|||||||0.962||||||Statistical significance threshold: 0.05|Two sample test of proportions|||||||0.962
72427695|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.45|STANDARD_ERROR_OF_MEAN|0.215||0.0388|TWO_SIDED|95.0|-0.87|-0.02|||MMRM|||Anxiety Psychic, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.02|-0.87|0.0388
72337115|NCT03500172|144197830|SUPERIORITY||Hazard Ratio (HR)|0.78|||<|0.05|TWO_SIDED|95.0|0.61|0.99||Threshold for statistical significance: 0.05|Regression, Cox|||Statistical test for risk of LTFU for steady partner, living together vs. single.||0.99|0.61|<0.05
72427696|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.29|STANDARD_ERROR_OF_MEAN|0.209||0.1622|TWO_SIDED|95.0|-0.71|0.12|||MMRM|||Anxiety Psychic, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.12|-0.71|0.1622
72427697|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.49|STANDARD_ERROR_OF_MEAN|0.204||0.0179|TWO_SIDED|95.0|-0.89|-0.09|||MMRM|||Anxiety Psychic, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.09|-0.89|0.0179
72427698|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.16|STANDARD_ERROR_OF_MEAN|0.198||0.4283|TWO_SIDED|95.0|-0.55|0.24|||MMRM|||Anxiety Psychic, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.24|-0.55|0.4283
72337116|NCT03500172|144197830|SUPERIORITY||Hazard Ratio (HR)|1.6|||<|0.05|TWO_SIDED|95.0|1.02|2.51||Threshold for statistical significance: 0.05|Regression, Cox|||Statistical test for risk of LTFU for 5-9 new clients in the past month vs. 0 clients in the past month.||2.51|1.02|<0.05
72337117|NCT03500172|144197830|SUPERIORITY||Hazard Ratio (HR)|1.31|||<|0.05|TWO_SIDED|95.0|1.09|1.57||Threshold for statistical significance: 0.05|Regression, Cox|||Statistical test for risk of LTFU for use of marijuana in the past 30 days vs. no marijuana use in the past 30 days||1.57|1.09|<0.05
72337118|NCT03500172|144197830|SUPERIORITY||Hazard Ratio (HR)|1.24|||<|0.05|TWO_SIDED|95.0|1.01|1.52||Threshold for statistical significance: 0.05|Regression, Cox|||Statistical test for risk of LTFU among those experiencing physical violence in the past 6 months vs. no experience of physical violence in the past 6 months.||1.52|1.01|<0.05
72337119|NCT03500172|144197830|SUPERIORITY||Hazard Ratio (HR)|1.62|||<|0.05|TWO_SIDED|95.0|1.31|2.0||Threshold for statistical significance: 0.05|Regression, Cox|||Statistical test for risk of LTFU among those who have experienced sexual violence in the past 6 months vs. those who have not||2.00|1.31|<0.05
72337120|NCT03500172|144197830|SUPERIORITY||Hazard Ratio (HR)|2.33|||<|0.05|TWO_SIDED|95.0|1.65|3.29||Threshold for statistical significance: 0.05|Regression, Cox|||Statistical test for risk of LTFU among those with viral loads from 50-1000 copies/mL at baseline vs. \<50 copies/mL.||3.29|1.65|<0.05
72337121|NCT03500172|144197830|SUPERIORITY||Hazard Ratio (HR)|2.47|||<|0.05|TWO_SIDED|95.0|1.82|3.36||Threshold for significance: 0.05|Regression, Cox|||Statistical test for risk of LTFU among those with viral load greater than 1000 copies/mL vs. those with viral load less than 50 copies/mL.||3.36|1.82|<0.05
72337122|NCT03500172|144197831|SUPERIORITY|||||||0.756||||||Threshold of significance: 0.05|Two sample test of proportions|||||||0.756
72337123|NCT03500172|144197832|SUPERIORITY|||||||0.295||||||Threshold of statistical significance: 0.05|Two sample test of proportions|||||||0.295
72337124|NCT03500172|144197833|SUPERIORITY|||||||0.149||||||Threshold for statistical significance: 0.05|Two sample test of proportions|||||||0.149
72337125|NCT03500172|144197834|SUPERIORITY|||||||0.301||||||Threshold of significance: 0.05|Two sample test of proportions|||||||0.301
72337126|NCT03500172|144197837|SUPERIORITY|||||||0.212||||||Threshold of statistical significance: 0.05|Chi-squared|||||||0.212
72337127|NCT00445848|144197866|OTHER||proportion of participants|0.78|||||TWO_SIDED|95.0|0.67|0.85||||||The overall survival rate at year 1 was estimated using Kaplan-Meier.||0.85|0.67|
72337128|NCT00445848|144197866|OTHER||proportion of participants|0.57|||||TWO_SIDED|95.0|0.46|0.67||||||The overall survival rate at year 2 was estimated using Kaplan-Meier.||0.67|0.46|
72337129|NCT00445848|144197866|OTHER||proportion of participants|0.43|||||TWO_SIDED|95.0|0.32|0.53||||||The overall survival rate at year 3 was estimated using Kaplan-Meier.||0.53|0.32|
72337130|NCT03832114|144197899|OTHER|Log Ratio to Baseline|Mean Difference (Final Values)|0.55||||0.0003|TWO_SIDED|80.0|0.46|0.65|||Mixed Model Repeated Measures (MMRM)|||||0.65|0.46|0.0003
72337131|NCT03832114|144197900|OTHER||Median Difference (Final Values)|-2.5||||0.0313|TWO_SIDED|80.0|-3.75|-0.75|||Wilcoxon (Mann-Whitney)|||||-0.75|-3.75|0.0313
72337132|NCT03832114|144197901|OTHER||Mean Difference (Final Values)|0.55||||0.0003|TWO_SIDED|80.0|0.46|0.65|||Mixed Model Repeated Measures (MMRM)|||Day 84||0.65|0.46|0.0003
72337133|NCT03832114|144197901|OTHER||Mean Difference (Final Values)|0.79||||0.4766|TWO_SIDED|80.0|0.49|1.28|||Mixed Model Repeated Measures (MMRM)|||Day 84||1.28|0.49|0.4766
72337134|NCT03832114|144197901|OTHER||Mean Difference (Final Values)|0.59||||0.0002|TWO_SIDED|80.0|0.51|0.69|||Mixed Model of Repeated Measures (MMRM)|||Overall- Day 84||0.69|0.51|0.0002
72337135|NCT03832114|144197902|OTHER||Mean Difference (Final Values)|0.57||||0.0011|TWO_SIDED|80.0|0.47|0.68|||Mixed Model Repeated Measures (MMRM|||Day 84||0.68|0.47|0.0011
72337136|NCT03832114|144197902|OTHER||Mean Difference (Final Values)|1.0||||0.9998|TWO_SIDED|80.0|0.75|1.33|||Mixed Model Repeated Measures (MMRM)|||Day 84||1.33|0.75|0.9998
72337137|NCT03832114|144197902|OTHER||Mean Difference (Final Values)|0.66||||0.0016|TWO_SIDED|80.0|0.56|0.77|||Mixed Model Repeated Measures (MMRM)|||Overall- Day 84||0.77|0.56|0.0016
72337138|NCT03832114|144197903|OTHER||Mean Difference (Final Values)|0.55|||<|0.0001|TWO_SIDED|80.0|0.47|0.64|||Mixed Model Repeated Measures (MRM)|||Day 84||0.64|0.47|<0.0001
72337139|NCT03832114|144197903|OTHER||Mean Difference (Final Values)|0.61||||0.3707|TWO_SIDED|80.0|0.3|1.27|||Mixed Model Repeated Measures (MMRM)|||Day 84||1.27|0.30|0.3707
72427699|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.29|STANDARD_ERROR_OF_MEAN|0.219||0.1899|TWO_SIDED|95.0|-0.72|0.15|||MMRM|||Anxiety Psychic, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.15|-0.72|0.1899
72427700|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.05|STANDARD_ERROR_OF_MEAN|0.213||0.8022|TWO_SIDED|95.0|-0.48|0.37|||MMRM|||Anxiety Psychic, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.37|-0.48|0.8022
72427701|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.19|STANDARD_ERROR_OF_MEAN|0.215||0.378|TWO_SIDED|95.0|-0.62|0.24|||MMRM|||Anxiety Psychic, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.24|-0.62|0.3780
72427702|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.05|STANDARD_ERROR_OF_MEAN|0.21||0.811|TWO_SIDED|95.0|-0.47|0.36|||MMRM|||Anxiety Psychic, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.36|-0.47|0.8110
72427703|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.04|STANDARD_ERROR_OF_MEAN|0.272||0.8908|TWO_SIDED|95.0|-0.58|0.5|||MMRM|||Anxiety Psychic, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.50|-0.58|0.8908
72427704|NCT02942004|144367030|SUPERIORITY||LS mean difference|0.24|STANDARD_ERROR_OF_MEAN|0.263||0.3596|TWO_SIDED|95.0|-0.28|0.76|||MMRM|||Anxiety Psychic, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.76|-0.28|0.3596
72427705|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.09|STANDARD_ERROR_OF_MEAN|0.293||0.7617|TWO_SIDED|95.0|-0.67|0.49|||MMRM|||Anxiety Psychic, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.49|-0.67|0.7617
72427706|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.17|STANDARD_ERROR_OF_MEAN|0.281||0.5498|TWO_SIDED|95.0|-0.73|0.39|||MMRM|||Anxiety Psychic, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.39|-0.73|0.5498
72427707|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.235||0.2066|TWO_SIDED|95.0|-0.76|0.17|||MMRM|||Anxiety Psychic, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.17|-0.76|0.2066
72427708|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.28|STANDARD_ERROR_OF_MEAN|0.23||0.2321|TWO_SIDED|95.0|-0.73|0.18|||MMRM|||Anxiety Psychic, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.18|-0.73|0.2321
72337140|NCT03832114|144197903|OTHER||Mean Difference (Final Values)|0.6||||0.0002|TWO_SIDED|80.0|0.51|0.71|||Mixed Model Repeated Measures (MMRM)|||Overall- Day 84||0.71|0.51|0.0002
72337141|NCT03832114|144197904|OTHER||Mean Difference (Final Values)|0.57||||0.0018|TWO_SIDED|80.0|0.47|0.7|||Mixed Model Repeated Measures (MMRM)|||Day 84||0.70|0.47|0.0018
72337142|NCT03832114|144197904|OTHER||Mean Difference (Final Values)|0.81||||0.1632|TWO_SIDED|80.0|0.67|0.98|||Mixed Model Repeated Measures (MMRM)|||Day 84||0.98|0.67|0.1632
72337143|NCT03832114|144197904|OTHER||Mean Difference (Final Values)|0.67||||0.004|TWO_SIDED|80.0|0.57|0.79|||Mixed Model Repeated Measure (MMRM)|||Overall- Day 84||0.79|0.57|0.0040
72337144|NCT03832114|144197905|OTHER||Mean Difference (Final Values)|2.59||||0.1795|TWO_SIDED|80.0|0.12|5.06|||Mixed Model of Repeated Measures (MMRM)|||Day 84||5.06|0.12|0.1795
72427709|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.11|STANDARD_ERROR_OF_MEAN|0.191||0.5582|TWO_SIDED|95.0|-0.49|0.27|||MMRM|||Anxiety Somatic, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.27|-0.49|0.5582
72427710|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.186||0.2945|TWO_SIDED|95.0|-0.56|0.17|||MMRM|||Anxiety Somatic, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.17|-0.56|0.2945
72427711|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.23|STANDARD_ERROR_OF_MEAN|0.208||0.2684|TWO_SIDED|95.0|-0.64|0.18|||MMRM|||Anxiety Somatic, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.18|-0.64|0.2684
72427712|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.02|STANDARD_ERROR_OF_MEAN|0.202||0.9396|TWO_SIDED|95.0|-0.42|0.39|||MMRM|||Anxiety Somatic, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.39|-0.42|0.9396
72427713|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.43|STANDARD_ERROR_OF_MEAN|0.195||0.0283|TWO_SIDED|95.0|-0.82|-0.05|||MMRM|||Anxiety Somatic, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.05|-0.82|0.0283
72427714|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.26|STANDARD_ERROR_OF_MEAN|0.189||0.1794|TWO_SIDED|95.0|-0.63|0.12|||MMRM|||Anxiety Somatic, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.12|-0.63|0.1794
72427715|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.188||0.1091|TWO_SIDED|95.0|-0.68|0.07|||MMRM|||Anxiety Somatic, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.07|-0.68|0.1091
72427716|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.05|STANDARD_ERROR_OF_MEAN|0.182||0.7921|TWO_SIDED|95.0|-0.41|0.31|||MMRM|||Anxiety Somatic, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.31|-0.41|0.7921
72427717|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.47|STANDARD_ERROR_OF_MEAN|0.166||0.0055|TWO_SIDED|95.0|-0.8|-0.14|||MMRM|||Anxiety Somatic, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.14|-0.80|0.0055
72427718|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.35|STANDARD_ERROR_OF_MEAN|0.161||0.03|TWO_SIDED|95.0|-0.67|-0.03|||MMRM|||Anxiety Somatic, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.03|-0.67|0.0300
72427719|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.47|STANDARD_ERROR_OF_MEAN|0.185||0.0118|TWO_SIDED|95.0|-0.84|-0.11|||MMRM|||Anxiety Somatic, Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.11|-0.84|0.0118
72427720|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.22|STANDARD_ERROR_OF_MEAN|0.178||0.2266|TWO_SIDED|95.0|-0.57|0.14|||MMRM|||Anxiety Somatic, Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.14|-0.57|0.2266
72427721|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.56|STANDARD_ERROR_OF_MEAN|0.181||0.0025|TWO_SIDED|95.0|-0.92|-0.2|||MMRM|||Anxiety Somatic, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.20|-0.92|0.0025
72427722|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.34|STANDARD_ERROR_OF_MEAN|0.176||0.0555|TWO_SIDED|95.0|-0.69|0.01|||MMRM|||Anxiety Somatic, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.01|-0.69|0.0555
72427723|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.58|STANDARD_ERROR_OF_MEAN|0.176||0.0013|TWO_SIDED|95.0|-0.93|-0.23|||MMRM|||Anxiety Somatic, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.23|-0.93|0.0013
72427724|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.31|STANDARD_ERROR_OF_MEAN|0.171||0.0775|TWO_SIDED|95.0|-0.64|0.03|||MMRM|||Anxiety Somatic, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.03|-0.64|0.0775
72427725|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.67|STANDARD_ERROR_OF_MEAN|0.19||0.0006|TWO_SIDED|95.0|-1.05|-0.3|||MMRM|||Anxiety Somatic, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.30|-1.05|0.0006
72427726|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.38|STANDARD_ERROR_OF_MEAN|0.185||0.0415|TWO_SIDED|95.0|-0.75|-0.01|||MMRM|||Anxiety Somatic, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.01|-0.75|0.0415
72427727|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.37|STANDARD_ERROR_OF_MEAN|0.193||0.0581|TWO_SIDED|95.0|-0.75|0.01|||MMRM|||Anxiety Somatic, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.01|-0.75|0.0581
72427728|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.08|STANDARD_ERROR_OF_MEAN|0.188||0.6826|TWO_SIDED|95.0|-0.45|0.3|||MMRM|||Anxiety Somatic, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.30|-0.45|0.6826
72427729|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.38|STANDARD_ERROR_OF_MEAN|0.226||0.0912|TWO_SIDED|95.0|-0.83|0.06|||MMRM|||Anxiety Somatic, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.06|-0.83|0.0912
72427730|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.19|STANDARD_ERROR_OF_MEAN|0.218||0.3988|TWO_SIDED|95.0|-0.62|0.25|||MMRM|||Anxiety Somatic, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.25|-0.62|0.3988
72427731|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.46|STANDARD_ERROR_OF_MEAN|0.231||0.0504|TWO_SIDED|95.0|-0.91|0.0|||MMRM|||Anxiety Somatic, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.00|-0.91|0.0504
72427732|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.12|STANDARD_ERROR_OF_MEAN|0.22||0.6019|TWO_SIDED|95.0|-0.55|0.32|||MMRM|||Anxiety Somatic, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.32|-0.55|0.6019
72337145|NCT03832114|144197905|OTHER||Mean Difference (Final Values)|-0.61||||0.7763|TWO_SIDED|0.7763|-3.36|2.15|||Mixed Model Repeated Measures (MMRM)|||Day 84||2.15|-3.36|0.7763
72337146|NCT03832114|144197905|OTHER||Mean Difference (Final Values)|1.32||||0.3754|TWO_SIDED|80.0|-0.59|3.22|||Mixed Model Repeated Measures (MMRM)|||Overall- Day 84||3.22|-0.59|0.3754
72337147|NCT03832114|144197906|OTHER||Mean Difference (Final Values)|-5.04||||0.1364|TWO_SIDED|80.0|-9.36|-0.72|||Mixed Model Repeated Measuers (MMRM)|||Day 84||-0.72|-9.36|0.1364
72337148|NCT03832114|144197906|OTHER||Mean Difference (Final Values)|7.17||||0.3038|TWO_SIDED|80.0|-1.79|16.13|||Mixed Model Repeated Measures (MMRM)|||Day 84||16.13|-1.79|0.3038
72337149|NCT03832114|144197906|OTHER||Mean Difference (Final Values)|-0.77||||0.8352|TWO_SIDED|80.0|-5.56|4.01|||Mixed Model Repeated Measures (MMRM)|||Overall- Day 84||4.01|-5.56|0.8352
72337150|NCT03832114|144197907|OTHER||Mean Difference (Final Values)|1.07||||0.2752|TWO_SIDED|80.0|0.99|1.17|||Mixed Model Repeated Measures (MMRM)|||Day 84||1.17|0.99|0.2752
72427733|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.61|STANDARD_ERROR_OF_MEAN|0.222||0.007|TWO_SIDED|95.0|-1.05|-0.17|||MMRM|||Anxiety Somatic, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.17|-1.05|0.0070
72337151|NCT03832114|144197907|OTHER||Mean Difference (Final Values)|1.2||||0.476|TWO_SIDED|80.0|0.83|1.72|||Mixed Model Repeated Measures (MMRM)|||Day 84||1.72|0.83|0.476
72337152|NCT03832114|144197907|OTHER||Mean Difference (Final Values)|1.1||||0.1963|TWO_SIDED|80.0|1.0|1.2|||Mixed Model Repeated Measures (MMRM)|||Overall- Day 84||1.20|1.00|0.1963
72337153|NCT03832114|144197909|OTHER||Mean Difference (Final Values)|0.56|||<|0.0001|TWO_SIDED|80.0|0.48|0.65|||Mixed Model Repeated Measures (MMRM)|||Day 64||0.65|0.48|<0.0001
72337154|NCT03832114|144197909|OTHER||Mean Difference (Final Values)|0.99||||0.9544|TWO_SIDED|80.0|0.76|1.28|||Mixed Model Repeated Measures (MMRM)|||Day 64||1.28|0.76|0.9544
72337155|NCT03832114|144197909|OTHER||Mean Difference (Final Values)|0.64|||<|0.0001|TWO_SIDED|80.0|0.56|0.72|||Mixed Model Repeated Measures (MMRM)|||Overall- Day 64||0.72|0.56|<.0001
72337156|NCT03832114|144197910|OTHER||Mean Difference (Final Values)|0.59|||<|0.0001|TWO_SIDED|80.0|0.5|0.69|||Mixed Model Repeated Measures (MMRM)|||Day 64||0.69|0.50|<.0001
72337157|NCT03832114|144197910|OTHER||Median Difference (Final Values)|0.87||||0.6209|TWO_SIDED|80.0|0.6|1.26|||Mixed Model Repeated Measures (MMRM)|||Day 64||1.26|0.60|0.6209
72337158|NCT03832114|144197910|OTHER||Mean Difference (Final Values)|0.63||||0.0002|TWO_SIDED|80.0|0.54|0.73|||Mixed Model Repeated Measures (MMRM)|||Overall- Day 64||0.73|0.54|0.0002
72337159|NCT01643850|144197919|SUPERIORITY||Mean Difference (Net)|0.98||||0.915|TWO_SIDED|95.0|0.71|1.36|||ANCOVA|||||1.36|0.71|0.915
72337160|NCT01643850|144197919|SUPERIORITY||Median Difference (Net)|0.78||||0.117|TWO_SIDED|95.0|0.57|1.07|||ANCOVA|||||1.07|0.57|0.117
72337161|NCT01643850|144197919|SUPERIORITY||Mean Difference (Net)|0.69||||0.01|TWO_SIDED|95.0|0.52|0.91|||ANCOVA|||||0.91|0.52|0.010
72337162|NCT03054350|144197949|SUPERIORITY||Least squares mean difference|1.19|STANDARD_ERROR_OF_MEAN|0.314||0.0004|TWO_SIDED|95.0|0.56|1.82|||ANCOVA|The analysis of covariance (ANCOVA) model includes treatment assignment (3 dosed groups; 1 placebo group) and pre-treatment Hb value as a covariate.||||1.82|0.56|0.0004
72337163|NCT03054350|144197949|SUPERIORITY||Least squares mean difference|1.56|STANDARD_ERROR_OF_MEAN|0.315|<|0.0001|TWO_SIDED|95.0|0.93|2.19|||ANCOVA|The ANCOVA model includes treatment assignment (3 dosed groups; 1 placebo group) and pre-treatment Hb value as a covariate.||||2.19|0.93|<0.0001
72337164|NCT03054350|144197949|SUPERIORITY||Least squares mean difference|1.89|STANDARD_ERROR_OF_MEAN|0.326|<|0.0001|TWO_SIDED|95.0|1.23|2.54|||ANCOVA|The ANCOVA model includes treatment assignment (3 dosed groups; 1 placebo group) and pre-treatment Hb value as a covariate.||||2.54|1.23|<0.0001
72337165|NCT03054350|144197955|SUPERIORITY||Least squares mean difference|0.29|STANDARD_ERROR_OF_MEAN|0.122||0.0232|TWO_SIDED|95.0|0.04|0.54|||ANCOVA|The ANCOVA model will include treatment assignment (3 dosed groups;1 placebo group) and pre-treatment Hb value as a covariate.||RBC Count||0.54|0.04|0.0232
72337166|NCT03054350|144197955|SUPERIORITY||Least squares mean difference|0.38|STANDARD_ERROR_OF_MEAN|0.121||0.0033|TWO_SIDED|95.0|0.13|0.62|||ANCOVA|The ANCOVA model will include treatment assignment (3 dosed groups; 1 placebo group) and pre-treatment Hb value as a covariate.||RBC Count||0.62|0.13|0.0033
72337167|NCT03054350|144197955|SUPERIORITY||Least squares mean difference|0.5|STANDARD_ERROR_OF_MEAN|0.12||0.0002|TWO_SIDED|95.0|0.26|0.74|||ANCOVA|The ANCOVA model will include treatment assignment (3 dosed groups; 1 placebo group) and pre-treatment Hb value as a covariate.||RBC Count||0.74|0.26|0.0002
72337168|NCT03054350|144197955|SUPERIORITY||Least squares mean difference|0.01|STANDARD_ERROR_OF_MEAN|0.008||0.3289|TWO_SIDED|94.0|-0.01|0.02|||ANCOVA|The ANCOVA model will include treatment assignment (3 dosed groups; 1 placebo group) and pre-treatment Hb value as a covariate.||Absolute Reticulocyte Count||0.02|-0.01|0.3289
72337169|NCT03054350|144197955|SUPERIORITY||Least squares mean difference|0.01|STANDARD_ERROR_OF_MEAN|0.007||0.2607|TWO_SIDED|95.0|-0.01|0.02|||ANCOVA|The ANCOVA model will include treatment assignment (3 dosed groups; 1 placebo group) and pre-treatment Hb value as a covariate.||Absolute Reticulocyte Count||0.02|-0.01|0.2607
72337170|NCT03054350|144197955|SUPERIORITY||Least squares mean difference|0.02|STANDARD_ERROR_OF_MEAN|0.007||0.0252|TWO_SIDED|95.0|0.0|0.03|||ANCOVA|The ANCOVA model will include treatment assignment (3 dosed groups; 1 placebo group) and pre-treatment Hb value as a covariate.||Absolute Reticulocyte Count||0.03|0.00|0.0252
72337171|NCT03054350|144197957|SUPERIORITY||Least squares mean difference|3.31|STANDARD_ERROR_OF_MEAN|1.303||0.0154|TWO_SIDED|95.0|0.67|5.94|||ANCOVA|The ANCOVA model will include treatment assignment (3 dosed groups; 1 placebo group) and pre-treatment Hb value as a covariate.||Hematocrit||5.94|0.67|0.0154
72337172|NCT03054350|144197957|SUPERIORITY||Least squares mean difference|4.61|STANDARD_ERROR_OF_MEAN|1.261||0.0008|TWO_SIDED|95.0|2.06|7.16|||ANCOVA|The ANCOVA model will include treatment assignment (3 dosed groups; 1 placebo group) and pre-treatment Hb value as a covariate.||Hematocrit||7.16|2.06|0.0008
72337173|NCT03054350|144197957|SUPERIORITY||Least squares mean difference|5.93|STANDARD_ERROR_OF_MEAN|1.296|<|0.0001|TWO_SIDED|95.0|3.31|8.56|||ANCOVA|The ANCOVA model will include treatment assignment (3 dosed groups; 1 placebo group) and pre-treatment Hb value as a covariate.||Hematocrit||8.56|3.31|<0.0001
72337174|NCT03054350|144197957|SUPERIORITY||Least squares mean difference|0.25|STANDARD_ERROR_OF_MEAN|0.273||0.3572|TWO_SIDED|95.0|-0.3|0.81|||ANCOVA|The ANCOVA model will include treatment assignment (3 dosed groups; 1 placebo group) and pre-treatment Hb value as a covariate.||Reticulocytes||0.81|-0.30|0.3572
72337175|NCT03054350|144197957|SUPERIORITY||Least squares mean difference|0.18|STANDARD_ERROR_OF_MEAN|0.252||0.4758|TWO_SIDED|95.0|-0.33|0.69|||ANCOVA|The ANCOVA model will include treatment assignment (3 dosed groups; 1 placebo group) and pre-treatment Hb value as a covariate.||Reticulocytes||0.69|-0.33|0.4758
72337176|NCT03054350|144197957|SUPERIORITY||Least squares mean difference|0.33|STANDARD_ERROR_OF_MEAN|0.254||0.2048|TWO_SIDED|95.0|-0.19|0.84|||ANCOVA|The ANCOVA model will include treatment assignment (3 dosed groups; 1 placebo group) and pre-treatment Hb value as a covariate.||Reticulocytes||0.84|-0.19|0.2048
72337177|NCT03054350|144197959|SUPERIORITY|||||||0.9373|||||||ANCOVA|test of treatment group difference based on ANCOVA model||Iron||||0.9373
72337178|NCT03054350|144197959|SUPERIORITY|||||||0.6623|||||||ANCOVA|test of treatment group difference based on ANCOVA model||Iron||||0.6623
72337179|NCT03054350|144197959|SUPERIORITY|||||||0.9374|||||||ANCOVA|test of treatment group difference based on ANCOVA model||Iron||||0.9374
72337180|NCT03054350|144197959|SUPERIORITY|||||||0.2085|||||||ANCOVA|test of treatment group difference based on ANCOVA model||TIBC||||0.2085
72337181|NCT03054350|144197959|SUPERIORITY|||||||0.0016|||||||ANCOVA|test of treatment group difference based on ANCOVA model||TIBC||||0.0016
72337182|NCT03054350|144197959|SUPERIORITY|||||||0.0001|||||||ANCOVA|test of treatment group difference based on ANCOVA model||TIBC||||0.0001
72337183|NCT03054350|144197961|SUPERIORITY|||||||0.2708|||||||ANCOVA|test of treatment group difference based on ANCOVA model||||||0.2708
72337184|NCT03054350|144197961|SUPERIORITY|||||||0.0966|||||||ANCOVA|test of treatment group difference based on ANCOVA model||||||0.0966
72337185|NCT03054350|144197961|SUPERIORITY|||||||0.0424|||||||ANCOVA|test of treatment group difference based on ANCOVA model||||||0.0424
72337186|NCT03054350|144197963|SUPERIORITY|||||||0.0207|||||||ANCOVA|test of treatment group difference based on ANCOVA model||Ferritin||||0.0207
72337187|NCT03054350|144197963|SUPERIORITY|||||||0.0022|||||||ANCOVA|test of treatment group difference based on ANCOVA model||Ferritin||||0.0022
72337188|NCT03054350|144197963|SUPERIORITY||||||<|0.0001|||||||ANCOVA|test of treatment group difference based on ANCOVA model||Ferritin||||<0.0001
72337189|NCT03054350|144197963|SUPERIORITY|||||||0.0062|||||||ANCOVA|test of treatment group difference based on ANCOVA model||Hepcidin||||0.0062
72337190|NCT03054350|144197963|SUPERIORITY|||||||0.0002|||||||ANCOVA|test of treatment group difference based on ANCOVA model||Hepcidin||||0.0002
72337191|NCT03054350|144197963|SUPERIORITY||||||<|0.0001||||||test of treatment group difference based on ANCOVA model|ANCOVA|||Hepcidin||||<0.0001
72337192|NCT04612842|144198029|SUPERIORITY||||||<|0.05|||||||Mixed Models Analysis|||||||<0.05
72337193|NCT02419131|144198040|SUPERIORITY|Superiority of the experimental arms (CBTH and CPT) compared to usual care (TAU)|Aggregated contrast CBTH to TAU|-3.4|||<|0.001|TWO_SIDED|95.0|-5.4|-1.4||p-value represents an aggregate of post-treatment outcomes (i.e., post-treatment, 3-month, and 6-month outcomes entered simultaneously into the GLMM to represent a single metric of all post-treatment assessment intervals into one estimate).|Mixed Models Analysis|Outcome observations at posttreatment, 3-month and 6-month follow-ups were entered simultaneously into the mixed model to provide a single inference.|Contrast of aggregated post-treatment outcomes of HIT-6 total score for CBTH compared to TAU|Sample size based on 2-tailed specified joint superiority testing of 2 primary outcomes at α = .025 and power of 0.80 to detect an effect size (d) of 0.52 for both primary outcomes (representing a clinically significant change of 2.8 points on the HIT-6). The primary analysis set was intention to treat (ITT). multiple imputation accounted for missing data in ITT. Missing outcome scores at posttreatment, 3-month, and 6-month follow-ups were multiply imputed (m = 100) using multilevel models.||-1.4|-5.4|<0.001
72337194|NCT02419131|144198040|SUPERIORITY|See previous section for analysis|Aggregated contrast CPT to TAU|-1.4||||0.21|TWO_SIDED|95.0|-3.7|0.8||For comparison of post-treatment HIT-6 total score between CPT and TAU|Mixed Models Analysis|See above for details.|See above.|See previous section for power||0.8|-3.7|0.21
72337195|NCT02419131|144198041|SUPERIORITY|Key parameters and details the same as HIT-6 described above.|Aggregated contrast CBTH to TAU|-6.5||||0.04|TWO_SIDED|95.0|-12.7|-0.3||Contrast of aggregate post-treatment outcomes between CBTH and TAU|Mixed Models Analysis|Contrast of aggregate post-treatment outcomes between CBTH and TAU||Same sample size calculation as HIT-6 analyses, powered to detect a difference of 8.2 points on the PCL-5 total score.||-0.3|-12.7|0.04
72337196|NCT02419131|144198041|SUPERIORITY|Contrast of aggregate post-treatment outcomes between CPT and TAU|Aggregated contrast CPT to TAU|-8.9||||0.01|TWO_SIDED|95.0|-15.9|-1.9||Contrast of aggregate post-treatment outcomes between CPT and TAU|Mixed Models Analysis|Contrast of aggregate post-treatment outcomes between CPT and TAU||See above.||-1.9|-15.9|0.01
72337197|NCT00089986|144198071|SUPERIORITY_OR_OTHER||Rate difference|1.1||||0.329|ONE_SIDED|90.0|-2.1||||Chi-squared||||||-2.1|0.329
72337198|NCT00089986|144198071|SUPERIORITY_OR_OTHER||Rate Difference|-4.4||||0.879|ONE_SIDED|90.0|-9.4||||Chi-squared||||||-9.4|0.879
72337199|NCT03995680|144198083|SUPERIORITY||Difference in Egg Reduction Rate (%)|2.3|||||TWO_SIDED|95.0|-7.8|12.6|||Regression, Logistic|Adjusted for age, sex, weight and baseline hookworm infection intensity (light or moderate/heavy)||The 95% confidence intervals (CIs) for ERRs and the difference between ERRs were estimated via bootstrap resampling. Superiority was claimed if the 95% confidence interval of the difference in ERRs did not include unity. Logistic regression models were used to assess efficacy in terms of CRs. In a subsequent analysis an adjusted logistic regression (adjustment for age, sex, weight and baseline infection intensity) was performed.||12.6|-7.8|
72337200|NCT01187004|144198100|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.0|||<|0.05|TWO_SIDED|95.0|||||Regression, Logistic|significant level for inclusion at the univariate analysis was p\<0.05.||Our hypothesis was that mechanical ventilation with large tidal volume might represent a risk factor for acute lung injury in patients undergoing cardiopulmonary bypass.||||<0.05
72337201|NCT01187004|144198101|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|1.199|||<|0.001|TWO_SIDED|95.0|1.129|1.272|||Wilcoxon (Mann-Whitney)|||||1.272|1.129|<0.001
72337202|NCT03410797|144198108|OTHER|Due to small sample size, nonparametric Wilcoxon signed-rank tests were used to compare VHI-10 before and after therapy.|Median Difference (Net)|7.0||||0.0076|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||Descriptive statistics characterized this patient perception measurement.||||.0076
72427734|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.19|STANDARD_ERROR_OF_MEAN|0.218||0.3785|TWO_SIDED|95.0|-0.62|0.24|||MMRM|||Anxiety Somatic, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.24|-0.62|0.3785
72427735|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.01|STANDARD_ERROR_OF_MEAN|0.159||0.9609|TWO_SIDED|95.0|-0.32|0.31|||MMRM|||Somatic Symptoms GI, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.31|-0.32|0.9609
72427736|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.02|STANDARD_ERROR_OF_MEAN|0.154||0.9183|TWO_SIDED|95.0|-0.32|0.29|||MMRM|||Somatic Symptoms GI, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.29|-0.32|0.9183
72427737|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.27|STANDARD_ERROR_OF_MEAN|0.149||0.071|TWO_SIDED|95.0|-0.57|0.02|||MMRM|||Somatic Symptoms GI, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.02|-0.57|0.0710
72427738|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.16|STANDARD_ERROR_OF_MEAN|0.143||0.2607|TWO_SIDED|95.0|-0.45|0.12|||MMRM|||Somatic Symptoms GI, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.12|-0.45|0.2607
72427739|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.18|STANDARD_ERROR_OF_MEAN|0.158||0.2466|TWO_SIDED|95.0|-0.5|0.13|||MMRM|||Somatic Symptoms GI, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.13|-0.50|0.2466
72427740|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.14|STANDARD_ERROR_OF_MEAN|0.153||0.3461|TWO_SIDED|95.0|-0.45|0.16|||MMRM|||Somatic Symptoms GI, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.16|-0.45|0.3461
72427741|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.28|STANDARD_ERROR_OF_MEAN|0.162||0.0919|TWO_SIDED|95.0|-0.6|0.05|||MMRM|||Somatic Symptoms GI, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.05|-0.60|0.0919
72427742|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.05|STANDARD_ERROR_OF_MEAN|0.157||0.7554|TWO_SIDED|95.0|-0.36|0.26|||MMRM|||Somatic Symptoms GI, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.26|-0.36|0.7554
72427743|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.41|STANDARD_ERROR_OF_MEAN|0.166||0.015|TWO_SIDED|95.0|-0.74|-0.08|||MMRM|||Somatic Symptoms GI, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.08|-0.74|0.0150
72427744|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.32|STANDARD_ERROR_OF_MEAN|0.16||0.0482|TWO_SIDED|95.0|-0.64|0.0|||MMRM|||Somatic Symptoms GI, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.00|-0.64|0.0482
72427745|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.61|STANDARD_ERROR_OF_MEAN|0.163||0.0003|TWO_SIDED|95.0|-0.93|-0.28|||MMRM|||Somatic Symptoms GI, Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.28|-0.93|0.0003
72337203|NCT03410797|144198109|OTHER|Descriptive statistics characterized acoustic and aerodynamic measures, and patient perception measurements.|Median Difference (Final Values)|-1.53||||0.0329|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||.0329
72337204|NCT03410797|144198110|OTHER|Descriptive statistics characterized acoustic and aerodynamic measures, and patient perception measurements.|Median Difference (Net)|15.39||||0.0164|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||.0164
72337205|NCT03410797|144198111|OTHER|Descriptive statistics characterized acoustic and aerodynamic measures, and patient perception measurements.|Median Difference (Net)|-52.0||||0.1141|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.1141
72337206|NCT03410797|144198112|OTHER|Descriptive statistics characterized acoustic and aerodynamic measures, and patient perception measurements.|Median Difference (Net)|-1.7||||0.3329|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.3329
72337207|NCT01185964|144198114|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.672||||0.0615|TWO_SIDED|95.0|0.442|1.021|||Log Rank|||||1.021|0.442|0.0615
72337208|NCT01185964|144198117|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.463||||0.0003|TWO_SIDED|95.0|0.301|0.71|||Log Rank|||||0.710|0.301|0.0003
72337209|NCT01920893|144198125|SUPERIORITY||Least Square (LS) mean difference|-1.55||||0.0009|TWO_SIDED|95.0|-2.43|-0.67||Threshold for significance at 0.05 level.|Mixed Models Analysis||Dupilumab 300 mg QW vs Placebo|Analysis was performed by a mixed model repeated measures (MMRM) model.||-0.67|-2.43|0.0009
72337210|NCT05894538|144198136|SUPERIORITY||Hazard Ratio (HR)|1.02|||||TWO_SIDED|95.0|0.92|1.12|||||The interval is a highest-density credible interval. Adjustment variables: randomization, age, sex, duration of symptoms prior to study drug, calendar time, vaccination status, geographic region, call center indicator, and baseline symptom severity.|||1.12|0.92|
72337211|NCT05894538|144198137|SUPERIORITY|Due to the low event rate, a posterior probability was not estimated.|Hazard Ratio (HR)|3.57|||||TWO_SIDED|95.0|0.74|17.18|||||Low event rate precluded covariate adjustment.|||17.18|0.74|
72337212|NCT05894538|144198140|SUPERIORITY||Hazard Ratio (HR)|0.97|||||TWO_SIDED|95.0|0.6|1.45|||||The interval is a highest-density credible interval. Adjustment variables: randomization, age, sex, duration of symptoms prior to study drug, calendar time, vaccination status, geographic region, call center indicator, and baseline symptom severity.|||1.45|0.60|
72337213|NCT05894538|144198144|OTHER||Odds Ratio (OR)|0.77|||||TWO_SIDED|95.0|0.61|0.96|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 7||0.96|0.61|
72337214|NCT05894538|144198144|OTHER||Odds Ratio (OR)|0.65|||||TWO_SIDED|95.0|0.49|0.85|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 14||0.85|0.49|
72337215|NCT05894538|144198144|OTHER||Odds Ratio (OR)|0.69|||||TWO_SIDED|95.0|0.52|0.92|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 28||0.92|0.52|
72337216|NCT05894538|144198144|OTHER||Odds Ratio (OR)|0.99|||||TWO_SIDED|95.0|0.72|1.36|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 90||1.36|0.72|
72337217|NCT05894538|144198145|OTHER||Odds Ratio (OR)|1.27|||||TWO_SIDED|95.0|1.03|1.56|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 7||1.56|1.03|
72337218|NCT05894538|144198145|OTHER||Odds Ratio (OR)|1.23|||||TWO_SIDED|95.0|1.0|1.51|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 14||1.51|1.00|
72337219|NCT05894538|144198145|OTHER||Odds Ratio (OR)|1.08|||||TWO_SIDED|95.0|0.87|1.35|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 28||1.35|0.87|
72337220|NCT05894538|144198145|OTHER||Odds Ratio (OR)|1.06|||||TWO_SIDED|95.0|0.86|1.32|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 90||1.32|0.86|
72337221|NCT05894538|144198146|OTHER||Odds Ratio (OR)|1.01|||||TWO_SIDED|95.0|0.81|1.26|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 7||1.26|0.81|
72337222|NCT05894538|144198146|OTHER||Odds Ratio (OR)|1.29|||||TWO_SIDED|95.0|1.0|1.66|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 14||1.66|1.00|
72337223|NCT05894538|144198146|OTHER||Odds Ratio (OR)|1.52|||||TWO_SIDED|95.0|1.15|2.02|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 28||2.02|1.15|
72337224|NCT05894538|144198146|OTHER||Odds Ratio (OR)|1.12|||||TWO_SIDED|95.0|0.86|1.47|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 90||1.47|0.86|
72337225|NCT05894538|144198147|OTHER||Odds Ratio (OR)|0.97|||||TWO_SIDED|95.0|0.76|1.24|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 7||1.24|0.76|
72337226|NCT05894538|144198147|OTHER||Odds Ratio (OR)|0.99|||||TWO_SIDED|95.0|0.75|1.3|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 14||1.30|0.75|
72337227|NCT05894538|144198147|OTHER||Odds Ratio (OR)|0.95|||||TWO_SIDED|95.0|0.72|1.25|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 28||1.25|0.72|
72337228|NCT05894538|144198147|OTHER||Odds Ratio (OR)|0.98|||||TWO_SIDED|95.0|0.75|1.28|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 90||1.28|0.75|
72337229|NCT05894538|144198148|OTHER||Odds Ratio (OR)|1.06|||||TWO_SIDED|95.0|0.84|1.33|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 7||1.33|0.84|
72337230|NCT05894538|144198148|OTHER||Odds Ratio (OR)|1.11|||||TWO_SIDED|95.0|0.87|1.43|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 14||1.43|0.87|
72337231|NCT05894538|144198148|OTHER||Odds Ratio (OR)|1.19|||||TWO_SIDED|95.0|0.91|1.55|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 28||1.55|0.91|
72337232|NCT05894538|144198148|OTHER||Odds Ratio (OR)|0.98|||||TWO_SIDED|95.0|0.75|1.26|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 90||1.26|0.75|
72337233|NCT05894538|144198149|OTHER||Odds Ratio (OR)|0.97|||||TWO_SIDED|95.0|0.79|1.2|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 7||1.20|0.79|
72337234|NCT05894538|144198149|OTHER||Odds Ratio (OR)|0.8|||||TWO_SIDED|95.0|0.63|1.02|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 14||1.02|0.63|
72337235|NCT05894538|144198149|OTHER||Odds Ratio (OR)|0.88|||||TWO_SIDED|95.0|0.69|1.14|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 28||1.14|0.69|
72337236|NCT05894538|144198149|OTHER||Odds Ratio (OR)|1.06|||||TWO_SIDED|95.0|0.84|1.35|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 90||1.35|0.84|
72337237|NCT05894538|144198150|OTHER||Odds Ratio (OR)|0.96|||||TWO_SIDED|95.0|0.78|1.19|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 7||1.19|0.78|
72337238|NCT05894538|144198150|OTHER||Odds Ratio (OR)|1.13|||||TWO_SIDED|95.0|0.92|1.39|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 14||1.39|0.92|
72337239|NCT05894538|144198150|OTHER||Odds Ratio (OR)|1.12|||||TWO_SIDED|95.0|0.91|1.36|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 28||1.36|0.91|
72337240|NCT05894538|144198150|OTHER||Odds Ratio (OR)|1.0|||||TWO_SIDED|95.0|0.82|1.21|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 90||1.21|0.82|
72337241|NCT05894538|144198151|SUPERIORITY||Difference in model estimate time unwell|-0.04|||||TWO_SIDED|95.0|-0.39|0.32|||||The interval is a highest-density credible interval.|||0.32|-0.39|
72337242|NCT01396265|144198171|NON_INFERIORITY_OR_EQUIVALENCE|Relative bioavailability|Geometric mean ratio|66.2|STANDARD_DEVIATION|16.1|||TWO_SIDED|90.0|60.815|72.057|||ANOVA|Adjusted geometric mean ratio|The standard deviation is actually the geometric coefficient of variation|||72.057|60.815|
72337243|NCT01396265|144198172|NON_INFERIORITY_OR_EQUIVALENCE|Relative bioavailability|Geometric mean ratio|66.18|STANDARD_DEVIATION|16.5|||TWO_SIDED|90.0|60.656|72.213|||ANOVA|Adjusted geometric mean ratio|The standard deviation is actually the geometric coefficient of variation|||72.213|60.656|
72337244|NCT01396265|144198173|NON_INFERIORITY_OR_EQUIVALENCE|Relative bioavailability|Geometric mean ratio|78.41|STANDARD_DEVIATION|15.6|||TWO_SIDED|90.0|72.363|84.968|||ANOVA|Adjusted geometric mean ratio|The standard deviation is actually the geometric coefficient of variation|||84.968|72.363|
72337245|NCT02081638|144198181|OTHER||||||>|0.05||||||Threshold for statistical significance was a priori set to \<0.05|Wilcoxon (Mann-Whitney)|||Wilcoxon rank sum test was used to compare the change of sCD14 from baseline and month 12 measurement within each arm.||||>0.05
72337246|NCT02081638|144198181|OTHER|||||||0.022|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon rank sum test was used to compare the change of sCD14 from baseline and month 12 measurement within each arm.||||0.022
72337247|NCT02081638|144198182|OTHER|||||||0.13|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon rank sum test was used to compare the change of sCD14 from baseline and month 12 measurement within each arm.||||0.13
72337248|NCT02081638|144198182|OTHER|||||||0.097|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon rank sum test was used to compare the change of sCD14 from baseline and month 12 measurement within each arm.||||0.097
72337249|NCT02081638|144198182|OTHER|||||||0.0269|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon rank sum test was used to compare the change of sCD14 from baseline and month 12 measurement within each arm.||||0.0269
72337250|NCT02081638|144198182|OTHER|||||||0.25|||||||Wilcoxon (Mann-Whitney)|||||||0.25
72337251|NCT02081638|144198182|OTHER||||||||||||||||||Plasma biomarkers (CRP, sCD14, TF, IL-6) were log(e) transformed and a linear mixed effect model with the biomarker as outcome and with random slope per participant was used to calculate the percentage of change from baseline.|||
72337252|NCT02275117|144198184|SUPERIORITY|75% Migraine Responder Rate - Week 1-12 (Modified Full Analysis Population)|Mean Difference (Final Values)|12.6||||0.033|TWO_SIDED|95.0|1.3|24.0|||Cochran-Mantel-Haenszel|||||24.0|1.3|0.0330
72337253|NCT02275117|144198184|SUPERIORITY|75% Migraine Responder Rate - Week 1-12 (Modified Full Analysis Population)|Mean Difference (Final Values)|10.7||||0.0715|TWO_SIDED|95.0|-0.5|21.8|||Cochran-Mantel-Haenszel|||||21.8|-0.5|0.0715
72337254|NCT02275117|144198184|SUPERIORITY|75% Migraine Responder Rate - Week 1-12 (Modified Full Analysis Population)|Mean Difference (Final Values)|7.5||||0.2013|TWO_SIDED|95.0|-3.5|18.5|||Cochran-Mantel-Haenszel|||||18.5|-3.5|0.2013
72337255|NCT02275117|144198184|SUPERIORITY|75% Migraine Responder Rate - Week 1-12 (Modified Full Analysis Population)|Mean Difference (Final Values)|6.1||||0.2938|TWO_SIDED|95.0|-4.6|16.9|||Cochran-Mantel-Haenszel|||||16.9|-4.6|0.2938
72337256|NCT02446418|144198204|NON_INFERIORITY|Non-inferiority of fixed combination FF/VI to usual ICS/LABA in inhalation powder was assessed assuming a non-inferiority margin of -1.5.|Mean Difference (Net)|0.8||||0.033|TWO_SIDED|95.0|0.1|1.5|||Mixed model repeated measures (MMRM)||||The analysis method was an MMRM adjusted for randomized treatment, visit (Week 6 and Week 12), Baseline ACT total score, randomized treatment-by-visit interaction, Baseline ACT total score-by-visit interaction, gender, age, country and participant fitted as a random factor. The Restricted Maximum Likelihood (REML) estimation approach was used with a default covariance structure of unstructured.|1.5|0.1|0.033
72337257|NCT02446418|144198205|NON_INFERIORITY|Non-inferiority of fixed combination FF/VI to usual ICS/LABA in inhalation powder was assessed assuming a non-inferiority margin of -1.5.|Mean Difference (Net)|0.4||||0.224|TWO_SIDED|95.0|-0.3|1.1|||Mixed model repeated measures (MMRM)||||The analysis method was an MMRM adjusted for randomized treatment, visit (Week 6, Week 12, Week 18 and Week 24), Baseline ACT total score, randomized treatment-by-visit interaction, Baseline ACT total score-by visit interaction, gender, age, country and participant fitted as a random factor. The REML estimation approach was used with a default covariance structure of unstructured.|1.1|-0.3|0.224
72337258|NCT02446418|144198206|SUPERIORITY||Adjusted Odds Ratio|1.11||||0.82|TWO_SIDED|95.0|0.47|2.62|||Regression, Logistic|||Week 12|The analysis method was logistic regression adjusted for randomized treatment, correct use of inhaler device at Baseline, gender, age and country.|2.62|0.47|0.820
72337259|NCT02446418|144198206|SUPERIORITY||Adjusted Odds Ratio|1.41||||0.566|TWO_SIDED|95.0|0.43|4.6|||Regression, Logistic|||Week 24|The analysis method was logistic regression adjusted for randomized treatment, correct use of inhaler device at Baseline, gender, age and country.|4.60|0.43|0.566
72337260|NCT02014480|144198212|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.108|||<|0.001|TWO_SIDED|95.0|0.065|0.151||Analysis was performed using an Analysis of Covariance (ANCOVA) model with covariates of treatment, period, mean Baseline, period Baseline, response type and treatment by response type interaction.|ANCOVA||Responders to UMEC=responders to UMEC or to both monotherapies, as defined by a participant with an increase from Baseline of \>=12% and 200 milliliters (mL) at \>=1 time point over 0-6 hours post-dose in FEV1 on Day 1.|||0.151|0.065|<0.001
72337261|NCT02014480|144198212|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.107|||<|0.001|TWO_SIDED|95.0|0.064|0.149||Analysis was performed using an Analysis of Covariance (ANCOVA) model with covariates of treatment, period, mean Baseline, period Baseline, response type and treatment by response type interaction.|ANCOVA||Responders to UMEC=responders to UMEC or to both monotherapies, as defined by a participant with an increase from Baseline of \>=12% and 200 mL at \>=1 time point over 0-6 hours post-dose in FEV1 on Day 1.|||0.149|0.064|<0.001
72337262|NCT02014480|144198212|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.129|||<|0.001|TWO_SIDED|95.0|0.086|0.171||Analysis was performed using an Analysis of Covariance (ANCOVA) model with covariates of treatment, period, mean Baseline, period Baseline, response type and treatment by response type interaction.|ANCOVA||Responders to VI=responders to VI or to both monotherapies, as defined by a participant with an increase from Baseline of \>=12% and 200 mL at \>=1 time point over 0-6 hours post-dose in FEV1 on Day 1.|||0.171|0.086|<0.001
72337263|NCT02014480|144198212|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.082|||<|0.001|TWO_SIDED|95.0|0.04|0.125||Analysis was performed using an Analysis of Covariance (ANCOVA) model with covariates of treatment, period, mean Baseline, period Baseline, response type and treatment by response type interaction.|ANCOVA||Responders to VI=responders to VI or to both monotherapies, as defined by a participant with an increase from Baseline of \>=12% and 200 mL at \>=1 time point over 0-6 hours post-dose in FEV1 on Day 1.|||0.125|0.040|<0.001
72337264|NCT02014480|144198212|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.078|||<|0.001|TWO_SIDED|95.0|0.036|0.12||Analysis was performed using an Analysis of Covariance (ANCOVA) model with covariates of treatment, period, mean Baseline, period Baseline, response type and treatment by response type interaction.|ANCOVA||Responders to Neither=responders to neither UMEC nor VI, as defined by a participant with at least one FEV1 assessment over 0-6 hours post-dose on Day 1 but no increase from Baseline of \>=12% and 200 mL at any assessment(s).|||0.120|0.036|<0.001
72337265|NCT02014480|144198212|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.057||||0.008|TWO_SIDED|95.0|0.015|0.099||Analysis was performed using an Analysis of Covariance (ANCOVA) model with covariates of treatment, period, mean Baseline, period Baseline, response type and treatment by response type interaction.|ANCOVA||Responders to Neither=responders to neither UMEC nor VI, as defined by a participant with at least one FEV1 assessment over 0-6 hours post-dose on Day 1 but no increase from Baseline of \>=12% and 200 mL at any assessment(s).|||0.099|0.015|0.008
72337266|NCT01865812|144198218|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.38|||||TWO_SIDED|95.0|-0.51|-0.24||||||||-0.24|-0.51|
72337267|NCT01865812|144198219|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.44|||||TWO_SIDED|95.0|-0.63|-0.25||||||||-0.25|-0.63|
72337268|NCT01865812|144198220|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.06|||||TWO_SIDED|95.0|-1.58|1.46||||||||1.46|-1.58|
72337269|NCT01865812|144198271|SUPERIORITY_OR_OTHER_LEGACY|||||||0.852|||||||ANCOVA|||||||0.852
72337270|NCT01865812|144198272|SUPERIORITY_OR_OTHER_LEGACY|||||||0.549|||||||ANCOVA|||||||0.549
72337271|NCT01865812|144198273|SUPERIORITY_OR_OTHER_LEGACY|||||||0.912|||||||ANCOVA|||||||0.912
72337272|NCT01854632|144198275|SUPERIORITY_OR_OTHER|||||||0.996|TWO_SIDED||||||Log Rank|||||||0.996
72337273|NCT01414205|144198286|SUPERIORITY_OR_OTHER||Difference (Hauck-Anderson)|17.89||||0.0779|TWO_SIDED|95.0|-4.95|40.72|||Cochran-Mantel-Haenszel|P-values based on stratified Cochran-Mantel-Haenszel test by the randomization stratification factors as supportive analyses.||||40.72|-4.95|0.0779
72337274|NCT01819129|144198348|NON_INFERIORITY_OR_EQUIVALENCE|The assessment was done by comparing the difference of faster aspart vs. NovoRapid®/NovoLog® in change from baseline in HbA1c after 26 weeks of randomized treatment to a non-inferiority limit of 0.4%.|Mean Difference (Net)|-0.02|||||TWO_SIDED|95.0|-0.15|0.1|||||The estimated parameter i.e mean difference is the estimated treatment difference for Faster aspart vs. NovoRapid (Faster aspart - NovoRapid).|Change from baseline in HbA1c is analysed using a mixed-effect model for repeated measurements including changes from baseline in HbA1c at visit 14, 18, 22, 26, 30 and 36. The model includes treatment, region and continuous glucose monitoring (CGM) strata as fixed effects, subject as random effect, HbA1c at baseline as covariate and interaction between all fixed effects and visit, and between the covariate and visit.||0.10|-0.15|
72427746|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.25|STANDARD_ERROR_OF_MEAN|0.156||0.1182|TWO_SIDED|95.0|-0.56|0.06|||MMRM|||Somatic Symptoms GI, Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.06|-0.56|0.1182
72427747|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.55|STANDARD_ERROR_OF_MEAN|0.159||0.0008|TWO_SIDED|95.0|-0.87|-0.24|||MMRM|||Somatic Symptoms GI, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.24|-0.87|0.0008
72427748|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.23|STANDARD_ERROR_OF_MEAN|0.154||0.1379|TWO_SIDED|95.0|-0.54|0.08|||MMRM|||Somatic Symptoms GI, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.08|-0.54|0.1379
72427749|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.43|STANDARD_ERROR_OF_MEAN|0.145||0.004|TWO_SIDED|95.0|-0.71|-0.14|||MMRM|||Somatic Symptoms GI, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.14|-0.71|0.0040
72427750|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.14|STANDARD_ERROR_OF_MEAN|0.14||0.31|TWO_SIDED|95.0|-0.42|0.14|||MMRM|||Somatic Symptoms GI, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.14|-0.42|0.3100
72427751|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.56|STANDARD_ERROR_OF_MEAN|0.148||0.0003|TWO_SIDED|95.0|-0.85|-0.26|||MMRM|||Somatic Symptoms GI, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.26|-0.85|0.0003
72427752|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.33|STANDARD_ERROR_OF_MEAN|0.143||0.0223|TWO_SIDED|95.0|-0.61|-0.05|||MMRM|||Somatic Symptoms GI, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.05|-0.61|0.0223
72427753|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.37|STANDARD_ERROR_OF_MEAN|0.166||0.0276|TWO_SIDED|95.0|-0.7|-0.04|||MMRM|||Somatic Symptoms GI, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.04|-0.70|0.0276
72427754|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.03|STANDARD_ERROR_OF_MEAN|0.161||0.8516|TWO_SIDED|95.0|-0.35|0.29|||MMRM|||Somatic Symptoms GI, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.29|-0.35|0.8516
72427755|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.26|STANDARD_ERROR_OF_MEAN|0.186||0.1669|TWO_SIDED|95.0|-0.63|0.11|||MMRM|||Somatic Symptoms GI, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.11|-0.63|0.1669
72427756|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.12|STANDARD_ERROR_OF_MEAN|0.18||0.4935|TWO_SIDED|95.0|-0.48|0.23|||MMRM|||Somatic Symptoms GI, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.23|-0.48|0.4935
72427757|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.47|STANDARD_ERROR_OF_MEAN|0.197||0.0202|TWO_SIDED|95.0|-0.86|-0.07|||MMRM|||Somatic Symptoms GI, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.07|-0.86|0.0202
72427758|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.21|STANDARD_ERROR_OF_MEAN|0.188||0.2683|TWO_SIDED|95.0|-0.58|0.16|||MMRM|||Somatic Symptoms GI, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.16|-0.58|0.2683
72427759|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.32|STANDARD_ERROR_OF_MEAN|0.165||0.0531|TWO_SIDED|95.0|-0.65|0.0|||MMRM|||Somatic Symptoms GI, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.00|-0.65|0.0531
72427760|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.09|STANDARD_ERROR_OF_MEAN|0.16||0.5609|TWO_SIDED|95.0|-0.41|0.22|||MMRM|||Somatic Symptoms GI, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.22|-0.41|0.5609
72427761|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.05|STANDARD_ERROR_OF_MEAN|0.123||0.6779|TWO_SIDED|95.0|-0.3|0.19|||MMRM|||Somatic Symptoms General, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.19|-0.30|0.6779
72427762|NCT02942004|144367030|SUPERIORITY||LS mean difference|0.09|STANDARD_ERROR_OF_MEAN|0.119||0.4559|TWO_SIDED|95.0|-0.15|0.32|||MMRM|||Somatic Symptoms General, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.32|-0.15|0.4559
72427763|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.16|STANDARD_ERROR_OF_MEAN|0.133||0.2254|TWO_SIDED|95.0|-0.43|0.1|||MMRM|||Somatic Symptoms General, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.10|-0.43|0.2254
72427764|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.06|STANDARD_ERROR_OF_MEAN|0.129||0.6437|TWO_SIDED|95.0|-0.32|0.2|||MMRM|||Somatic Symptoms General, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.20|-0.32|0.6437
72427765|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.06|STANDARD_ERROR_OF_MEAN|0.133||0.6678|TWO_SIDED|95.0|-0.32|0.21|||MMRM|||Somatic Symptoms General, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.21|-0.32|0.6678
72427766|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.01|STANDARD_ERROR_OF_MEAN|0.129||0.9321|TWO_SIDED|95.0|-0.27|0.24|||MMRM|||Somatic Symptoms General, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.24|-0.27|0.9321
72427767|NCT02942004|144367030|SUPERIORITY||LS mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.157||0.9778|TWO_SIDED|95.0|-0.31|0.32|||MMRM|||Somatic Symptoms General, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.32|-0.31|0.9778
72427768|NCT02942004|144367030|SUPERIORITY||LS mean difference|0.01|STANDARD_ERROR_OF_MEAN|0.152||0.9307|TWO_SIDED|95.0|-0.29|0.31|||MMRM|||Somatic Symptoms General, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.31|-0.29|0.9307
72427769|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.07|STANDARD_ERROR_OF_MEAN|0.172||0.6791|TWO_SIDED|95.0|-0.41|0.27|||MMRM|||Somatic Symptoms General, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.27|-0.41|0.6791
72427770|NCT02942004|144367030|SUPERIORITY||LS mean difference|0.05|STANDARD_ERROR_OF_MEAN|0.167||0.7769|TWO_SIDED|95.0|-0.28|0.38|||MMRM|||Somatic Symptoms General, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.38|-0.28|0.7769
72427771|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.06|STANDARD_ERROR_OF_MEAN|0.163||0.7206|TWO_SIDED|95.0|-0.38|0.26|||MMRM|||Somatic Symptoms General, Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.26|-0.38|0.7206
72427772|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.15|STANDARD_ERROR_OF_MEAN|0.156||0.3549|TWO_SIDED|95.0|-0.45|0.16|||MMRM|||Somatic Symptoms General, Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.16|-0.45|0.3549
72427773|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.38|STANDARD_ERROR_OF_MEAN|0.164||0.0231|TWO_SIDED|95.0|-0.7|-0.05|||MMRM|||Somatic Symptoms General, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.05|-0.70|0.0231
72427774|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.23|STANDARD_ERROR_OF_MEAN|0.159||0.145|TWO_SIDED|95.0|-0.55|0.08|||MMRM|||Somatic Symptoms General, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.08|-0.55|0.1450
72427775|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.28|STANDARD_ERROR_OF_MEAN|0.162||0.0855|TWO_SIDED|95.0|-0.6|0.04|||MMRM|||Somatic Symptoms General, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.04|-0.60|0.0855
72427776|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.16|STANDARD_ERROR_OF_MEAN|0.157||0.3068|TWO_SIDED|95.0|-0.47|0.15|||MMRM|||Somatic Symptoms General, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.15|-0.47|0.3068
72427777|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.45|STANDARD_ERROR_OF_MEAN|0.164||0.0069|TWO_SIDED|95.0|-0.77|-0.13|||MMRM|||Somatic Symptoms General, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.13|-0.77|0.0069
72427778|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.159||0.2174|TWO_SIDED|95.0|-0.51|0.12|||MMRM|||Somatic Symptoms General, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.12|-0.51|0.2174
72427779|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.29|STANDARD_ERROR_OF_MEAN|0.174||0.102|TWO_SIDED|95.0|-0.63|0.06|||MMRM|||Somatic Symptoms General, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.06|-0.63|0.1020
72427780|NCT02942004|144367030|SUPERIORITY||LS mean difference|0.01|STANDARD_ERROR_OF_MEAN|0.17||0.9587|TWO_SIDED|95.0|-0.33|0.35|||MMRM|||Somatic Symptoms General, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.35|-0.33|0.9587
72427781|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.28|STANDARD_ERROR_OF_MEAN|0.203||0.169|TWO_SIDED|95.0|-0.69|0.12|||MMRM|||Somatic Symptoms General, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.12|-0.69|0.1690
72337275|NCT02836873|144198352|SUPERIORITY||Difference of LS Means|-0.28||||0.0026|TWO_SIDED|95.0|-0.46|-0.1|||Mixed-effects repeated measures|Region, screening anti-diabetic treatment, baseline eGFR, treatment, visit, treatment-by-visit and baseline HbA1c value as fixed effect covariates.||This is a mixed-effects repeated measures analysis including region, screening anti-diabetic treatment regimen, baseline eGFR, treatment, visit, treatment-by-visit interaction and baseline HbA1c as a fixed effect covariate. Data from Weeks 6, 12, and 24 are used in the model.||-0.10|-0.46|0.0026
72337276|NCT02836873|144198353|SUPERIORITY||Difference of LS Means|-1.76|||<|0.0001|TWO_SIDED|95.0|-2.5|-1.03|||Mixed-effects repeated measures|Region, screening anti-diabetic treatment, baseline eGFR, treatment, visit, treatment-by-visit and baseline HbA1c value as fixed effect covariates.||||-1.03|-2.50|< 0.0001
72337277|NCT02836873|144198354|SUPERIORITY||Difference of LS Means|-2.63||||0.2035|TWO_SIDED|95.0|-6.7|1.44|||Mixed-effects repeated measures|Region, screening anti-diabetic treatment, baseline eGFR, treatment, visit, treatment-by-visit and baseline HbA1c value as fixed effect covariates.||||1.44|-6.70|0.2035
72337278|NCT02836873|144198355|SUPERIORITY||Difference of LS Means|-0.2||||0.1156|TWO_SIDED|95.0|-0.44|0.05|||Mixed-effects repeated measures|Region, screening anti-diabetic treatment, baseline eGFR, treatment, visit, treatment-by-visit and baseline HbA1c value as fixed effect covariates.||||0.05|-0.44|0.1156
72337279|NCT02836873|144198356|SUPERIORITY||Difference of LS Means|-0.37||||0.0078|TWO_SIDED|95.0|-0.65|-0.1|||Mixed-effects repeated measures|Region, screening anti-diabetic treatment, baseline eGFR, treatment, visit, treatment-by-visit and baseline HbA1c value as fixed effect covariates.||||-0.10|-0.65|0.0078
72337280|NCT02214225|144198369|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority criterion for the GMT ratio was that the upper bound of two-sided 95% CI on the ratio of Pooled TIV (for A strains) or TIV-1 (B Yamagata) or TIV-2 (B Victoria)/ bioCSL QIV should not exceed 1.5.|GMT ratio (A/H1N1)|0.92|||||TWO_SIDED|95.0|0.87|0.98||||||For A/H1N1 strain. The GMT ratio (defined as the geometric mean of postvaccination (day 21) HI titer for TIV divided by the geometric mean of the postvaccination HI titer for QIV) for each virus strain included in the vaccines was determined: bioCSL TIV-1 and bioCSL TIV-2 GMTs were pooled for analysis of the A strains.||0.98|0.87|
72337281|NCT02214225|144198369|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority criterion for the GMT ratio was that the upper bound of two-sided 95% CI on the ratio of Pooled TIV (for A strains) or TIV-1 (B Yamagata) or TIV-2 (B Victoria)/ bioCSL QIV should not exceed 1.5.|GMT ratio (A/H3N2)|0.93|||||TWO_SIDED|95.0|0.88|0.98||||||For A/H3N2 strain. The GMT ratio (defined as the geometric mean of postvaccination (day 21) HI titer for TIV divided by the geometric mean of the postvaccination HI titer for QIV) for each virus strain included in the vaccines was determined: bioCSL TIV-1 and bioCSL TIV-2 GMTs were pooled for analysis of the A strains.||0.98|0.88|
72337282|NCT02214225|144198369|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority criterion for the GMT ratio was that the upper bound of two-sided 95% CI on the ratio of Pooled TIV (for A strains) or TIV-1 (B Yamagata) or TIV-2 (B Victoria)/ bioCSL QIV should not exceed 1.5.|GMT ratio (B/YAM)|0.87|||||TWO_SIDED|95.0|0.81|0.93||||||For B/Yamagata strain. The GMT ratio (defined as the geometric mean of postvaccination (day 21) HI titer for TIV divided by the geometric mean of the postvaccination HI titer for QIV) for each virus strain included in the vaccines was determined: bioCSL TIV-1 and bioCSL TIV-2 GMTs were pooled for analysis of the A strains.||0.93|0.81|
72369869|NCT04881942|144250168|EQUIVALENCE|Null Hypothesis: Mean Puff Count is equal to 0 Alternative Hypothesis: Mean Puff Count is not equal to 0|Mean Difference (Final Values)|257.92|||<|0.0001|TWO_SIDED|95.0|193.58|322.26|||ANCOVA||LSM calculated from mixed models. Each model includes fixed effect terms for product, period and sequence.|Null Hypothesis: Mean Puff Count is equal to 0 Alternative Hypothesis: Mean Puff Count is not equal to 0||322.26|193.58|<.0001
72369870|NCT04881942|144250169|EQUIVALENCE|Null Hypothesis: Mean Average Puff Duration is equal to 0 Alternative Hypothesis: Mean Average Puff Duration is not equal to 0|Mean Difference (Final Values)|2.223|||<|0.0001|TWO_SIDED|95.0|1.915|2.58|||ANCOVA||LSM calculated from mixed models. Each model includes fixed effect terms for product, period and sequence.|Null Hypothesis: Mean Average Puff Duration is equal to 0 Alternative Hypothesis: Mean Average Puff Duration is not equal to 0||2.580|1.915|<.0001
72369871|NCT04881942|144250169|EQUIVALENCE|Null Hypothesis: Mean Average Puff Duration is equal to 0 Alternative Hypothesis: Mean Average Puff Duration is not equal to 0|Mean Difference (Final Values)|2.203|||<|0.0001|TWO_SIDED|95.0|1.897|2.557|||ANCOVA||LSM calculated from mixed models. Each model includes fixed effect terms for product, period and sequence.|Null Hypothesis: Mean Average Puff Duration is equal to 0 Alternative Hypothesis: Mean Average Puff Duration is not equal to 0||2.557|1.897|<.0001
72369872|NCT04881942|144250169|EQUIVALENCE|Null Hypothesis: Mean Average Puff Duration is equal to 0 Alternative Hypothesis: Mean Average Puff Duration is not equal to 0|Mean Difference (Final Values)|2.101|||<|0.0001|TWO_SIDED|95.0|1.81|2.439|||ANCOVA||LSM calculated from mixed models. Each model includes fixed effect terms for product, period and sequence.|Null Hypothesis: Mean Average Puff Duration is equal to 0 Alternative Hypothesis: Mean Average Puff Duration is not equal to 0||2.439|1.810|<.0001
72369873|NCT04881942|144250169|EQUIVALENCE|Null Hypothesis: Mean Total Puff Duration is equal to 0 Alternative Hypothesis: Mean Total Puff Duration is not equal to 0|Mean Difference (Final Values)|2.052|||<|0.0001|TWO_SIDED|95.0|1.767|2.382|||ANCOVA||LSM calculated from mixed models. Each model includes fixed effect terms for product, period and sequence.|Null Hypothesis: Mean Average Puff Duration is equal to 0 Alternative Hypothesis: Mean Average Puff Duration is not equal to 0||2.382|1.767|<.0001
72369874|NCT04881942|144250170|EQUIVALENCE|Null Hypothesis: Mean Total Puff Duration is equal to 0 Alternative Hypothesis: Mean Total Puff Duration is not equal to 0|Mean Difference (Final Values)|709.86|||<|0.0001|TWO_SIDED|95.0|549.19|870.54|||ANCOVA||LSM calculated from mixed models. Each model includes fixed effect terms for product, period and sequence.|Null Hypothesis: Mean Total Puff Duration is equal to 0 Alternative Hypothesis: Mean Total Puff Duration is not equal to 0||870.54|549.19|<.0001
72427782|NCT02942004|144367030|SUPERIORITY||LS mean difference|0.05|STANDARD_ERROR_OF_MEAN|0.197||0.7919|TWO_SIDED|95.0|-0.34|0.44|||MMRM|||Somatic Symptoms General, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.44|-0.34|0.7919
72427783|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.49|STANDARD_ERROR_OF_MEAN|0.205||0.0192|TWO_SIDED|95.0|-0.89|-0.08|||MMRM|||Somatic Symptoms General, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.08|-0.89|0.0192
72427784|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.17|STANDARD_ERROR_OF_MEAN|0.196||0.3887|TWO_SIDED|95.0|-0.56|0.22|||MMRM|||Somatic Symptoms General, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.22|-0.56|0.3887
72427785|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.34|STANDARD_ERROR_OF_MEAN|0.189||0.0719|TWO_SIDED|95.0|-0.72|0.03|||MMRM|||Somatic Symptoms General, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.03|-0.72|0.0719
72427786|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.29|STANDARD_ERROR_OF_MEAN|0.185||0.1195|TWO_SIDED|95.0|-0.66|0.08|||MMRM|||Somatic Symptoms General, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.08|-0.66|0.1195
72427787|NCT02942004|144367030|SUPERIORITY||LS mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.079||0.9552|TWO_SIDED|95.0|-0.16|0.15|||MMRM|||Genital Symptoms, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.15|-0.16|0.9552
72427788|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.16|STANDARD_ERROR_OF_MEAN|0.076||0.0384|TWO_SIDED|95.0|-0.31|-0.01|||MMRM|||Genital Symptoms, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.01|-0.31|0.0384
72427789|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.11|STANDARD_ERROR_OF_MEAN|0.097||0.2582|TWO_SIDED|95.0|-0.3|0.08|||MMRM|||Genital Symptoms, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.08|-0.30|0.2582
72427790|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.14|STANDARD_ERROR_OF_MEAN|0.094||0.1511|TWO_SIDED|95.0|-0.32|0.05|||MMRM|||Genital Symptoms, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.05|-0.32|0.1511
72427791|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.09|STANDARD_ERROR_OF_MEAN|0.126||0.4631|TWO_SIDED|95.0|-0.34|0.16|||MMRM|||Genital Symptoms, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.16|-0.34|0.4631
72427792|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.09|STANDARD_ERROR_OF_MEAN|0.123||0.4628|TWO_SIDED|95.0|-0.33|0.15|||MMRM|||Genital Symptoms, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.15|-0.33|0.4628
72427793|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.01|STANDARD_ERROR_OF_MEAN|0.11||0.9005|TWO_SIDED|95.0|-0.23|0.2|||MMRM|||Genital Symptoms, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.20|-0.23|0.9005
72427794|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.17|STANDARD_ERROR_OF_MEAN|0.107||0.1121|TWO_SIDED|95.0|-0.38|0.04|||MMRM|||Genital Symptoms, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.04|-0.38|0.1121
72427795|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.12|STANDARD_ERROR_OF_MEAN|0.145||0.4167|TWO_SIDED|95.0|-0.4|0.17|||MMRM|||Genital Symptoms, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.17|-0.40|0.4167
72427796|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.12|STANDARD_ERROR_OF_MEAN|0.141||0.4071|TWO_SIDED|95.0|-0.4|0.16|||MMRM|||Genital Symptoms, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.16|-0.40|0.4071
72427797|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.23|STANDARD_ERROR_OF_MEAN|0.15||0.1278|TWO_SIDED|95.0|-0.53|0.07|||MMRM|||Genital Symptoms, Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.07|-0.53|0.1278
72427798|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.28|STANDARD_ERROR_OF_MEAN|0.145||0.0573|TWO_SIDED|95.0|-0.57|0.01|||MMRM|||Genital Symptoms, Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.01|-0.57|0.0573
72427799|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.11|STANDARD_ERROR_OF_MEAN|0.156||0.4842|TWO_SIDED|95.0|-0.42|0.2|||MMRM|||Genital Symptoms, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.20|-0.42|0.4842
72427800|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.28|STANDARD_ERROR_OF_MEAN|0.152||0.0692|TWO_SIDED|95.0|-0.58|0.02|||MMRM|||Genital Symptoms, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.02|-0.58|0.0692
72427801|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.13|STANDARD_ERROR_OF_MEAN|0.157||0.4028|TWO_SIDED|95.0|-0.44|0.18|||MMRM|||Genital Symptoms, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.18|-0.44|0.4028
72427802|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.33|STANDARD_ERROR_OF_MEAN|0.154||0.0354|TWO_SIDED|95.0|-0.63|-0.02|||MMRM|||Genital Symptoms, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.02|-0.63|0.0354
72337283|NCT02214225|144198369|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority criterion for the GMT ratio was that the upper bound of two-sided 95% CI on the ratio of Pooled TIV (for A strains) or TIV-1 (B Yamagata) or TIV-2 (B Victoria)/ bioCSL QIV should not exceed 1.5.|GMT ratio (B/VIC)|0.94|||||TWO_SIDED|95.0|0.86|1.01||||||For B/Victoria strain. The GMT ratio (defined as the geometric mean of postvaccination (day 21) HI titer for TIV divided by the geometric mean of the postvaccination HI titer for QIV) for each virus strain included in the vaccines was determined: bioCSL TIV-1 and bioCSL TIV-2 GMTs were pooled for analysis of the A strains.||1.01|0.86|
72337284|NCT02214225|144198370|NON_INFERIORITY_OR_EQUIVALENCE|For A/H1N1. The non-inferiority criterion was that the upper bound of the two sided 95% CI on the difference between SCRs (Pooled TIV or TIV-1 (B Yamagata) or TIV-2 (B Victoria) minus bioCSL QIV) should not exceed 10%.|Difference in SCR (A/H1N1)|-1.1|||||TWO_SIDED|95.0|-4.4|2.2||||||||2.2|-4.4|
72337285|NCT02214225|144198370|NON_INFERIORITY_OR_EQUIVALENCE|For A/H3N2. The non-inferiority criterion was that the upper bound of the two sided 95% CI on the difference between SCRs (Pooled TIV or TIV-1 (B Yamagata) or TIV-2 (B Victoria) minus bioCSL QIV) should not exceed 10%.|Difference in SCR (A/H3N2)|-1.7|||||TWO_SIDED|95.0|-5.0|1.6||||||||1.6|-5.0|
72337286|NCT02214225|144198370|NON_INFERIORITY_OR_EQUIVALENCE|For B/Yamagata. The non-inferiority criterion was that the upper bound of the two sided 95% CI on the difference between SCRs (Pooled TIV or TIV-1 (B Yamagata) or TIV-2 (B Victoria) minus bioCSL QIV) should not exceed 10%.|Difference in SCR (B/YAM)|-3.2|||||TWO_SIDED|95.0|-7.0|0.5||||||||0.5|-7.0|
72337287|NCT02214225|144198370|NON_INFERIORITY_OR_EQUIVALENCE|For B/Victoria. The non-inferiority criterion was that the upper bound of the two sided 95% CI on the difference between SCRs (Pooled TIV or TIV-1 (B Yamagata) or TIV-2 (B Victoria) minus bioCSL QIV) should not exceed 10%.|Difference in SCR (B/VIC)|-1.6|||||TWO_SIDED|95.0|-5.6|2.4||||||||2.4|-5.6|
72337288|NCT02214225|144198371|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority criterion for the GMT ratio was that the upper bound of two-sided 95% CI on the ratio of Pooled TIV (for A strains) or TIV-1 (B Yamagata) or TIV-2 (B Victoria)/ bioCSL QIV should not exceed 1.5.|GMT ratio (A/H1N1)|0.93|||||TWO_SIDED|95.0|0.85|1.02||||||For A/H1N1 strain. The GMT ratio (defined as the geometric mean of postvaccination (day 21) HI titer for TIV divided by the geometric mean of the postvaccination HI titer for QIV) for each virus strain included in the vaccines was determined: bioCSL TIV-1 and bioCSL TIV-2 GMTs were pooled for analysis of the A strains.||1.02|0.85|
72337289|NCT02214225|144198371|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority criterion for the GMT ratio was that the upper bound of two-sided 95% CI on the ratio of Pooled TIV (for A strains) or TIV-1 (B Yamagata) or TIV-2 (B Victoria)/ bioCSL QIV should not exceed 1.5.|GMT ratio (A/H3N2)|0.91|||||TWO_SIDED|95.0|0.83|0.99||||||For A/H3N2 strain. The GMT ratio (defined as the geometric mean of postvaccination (day 21) HI titer for TIV divided by the geometric mean of the postvaccination HI titer for QIV) for each virus strain included in the vaccines was determined: bioCSL TIV-1 and bioCSL TIV-2 GMTs were pooled for analysis of the A strains.||0.99|0.83|
72337290|NCT02214225|144198371|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority criterion for the GMT ratio was that the upper bound of two-sided 95% CI on the ratio of Pooled TIV (for A strains) or TIV-1 (B Yamagata) or TIV-2 (B Victoria)/ bioCSL QIV should not exceed 1.5.|GMT ratio (B/YAM)|0.86|||||TWO_SIDED|95.0|0.76|0.97||||||For B/YAM strain. The GMT ratio (defined as the geometric mean of postvaccination (day 21) HI titer for TIV divided by the geometric mean of the postvaccination HI titer for QIV) for each virus strain included in the vaccines was determined: bioCSL TIV-1 and bioCSL TIV-2 GMTs were pooled for analysis of the A strains.||0.97|0.76|
72337291|NCT02214225|144198371|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority criterion for the GMT ratio was that the upper bound of two-sided 95% CI on the ratio of Pooled TIV (for A strains) or TIV-1 (B Yamagata) or TIV-2 (B Victoria)/ bioCSL QIV should not exceed 1.5.|GMT ratio (B/VIC)|0.86|||||TWO_SIDED|95.0|0.76|0.98||||||For B/VIC strain. The GMT ratio (defined as the geometric mean of postvaccination (day 21) HI titer for TIV divided by the geometric mean of the postvaccination HI titer for QIV) for each virus strain included in the vaccines was determined: bioCSL TIV-1 and bioCSL TIV-2 GMTs were pooled for analysis of the A strains.||0.98|0.76|
72337292|NCT02214225|144198371|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority criterion for the GMT ratio was that the upper bound of two-sided 95% CI on the ratio of Pooled TIV (for A strains) or TIV-1 (B Yamagata) or TIV-2 (B Victoria)/ bioCSL QIV should not exceed 1.5.|GMT ratio (A/H1N1)|0.95|||||TWO_SIDED|95.0|0.88|1.02||||||For A/H1N1 strain. The GMT ratio (defined as the geometric mean of postvaccination (day 21) HI titer for TIV divided by the geometric mean of the postvaccination HI titer for QIV) for each virus strain included in the vaccines was determined: bioCSL TIV-1 and bioCSL TIV-2 GMTs were pooled for analysis of the A strains.||1.02|0.88|
72337293|NCT02214225|144198371|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority criterion for the GMT ratio was that the upper bound of two-sided 95% CI on the ratio of Pooled TIV (for A strains) or TIV-1 (B Yamagata) or TIV-2 (B Victoria)/ bioCSL QIV should not exceed 1.5.|GMT ratio (A/H3N2)|0.95|||||TWO_SIDED|95.0|0.89|1.02||||||For A/H3N2 strain. The GMT ratio (defined as the geometric mean of postvaccination (day 21) HI titer for TIV divided by the geometric mean of the postvaccination HI titer for QIV) for each virus strain included in the vaccines was determined: bioCSL TIV-1 and bioCSL TIV-2 GMTs were pooled for analysis of the A strains.||1.02|0.89|
72369875|NCT04881942|144250170|EQUIVALENCE|Null Hypothesis: Mean Total Puff Duration is equal to 0 Alternative Hypothesis: Mean Total Puff Duration is not equal to 0|Mean Difference (Final Values)|568.35|||<|0.0001|TWO_SIDED|95.0|407.18|729.51|||ANCOVA||LSM calculated from mixed models. Each model includes fixed effect terms for product, period and sequence.|Null Hypothesis: Mean Total Puff Duration is equal to 0 Alternative Hypothesis: Mean Total Puff Duration is not equal to 0||729.51|407.18|<.0001
72337294|NCT02214225|144198371|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority criterion for the GMT ratio was that the upper bound of two-sided 95% CI on the ratio of Pooled TIV (for A strains) or TIV-1 (B Yamagata) or TIV-2 (B Victoria)/ bioCSL QIV should not exceed 1.5.|GMT ratio (B/YAM)|0.9|||||TWO_SIDED|95.0|0.84|0.97||||||For B/YAM strain. The GMT ratio (defined as the geometric mean of postvaccination (day 21) HI titer for TIV divided by the geometric mean of the postvaccination HI titer for QIV) for each virus strain included in the vaccines was determined: bioCSL TIV-1 and bioCSL TIV-2 GMTs were pooled for analysis of the A strains.||0.97|0.84|
72427803|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.24|STANDARD_ERROR_OF_MEAN|0.156||0.1228|TWO_SIDED|95.0|-0.55|0.07|||MMRM|||Genital Symptoms, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.07|-0.55|0.1228
72427804|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.152||0.0099|TWO_SIDED|95.0|-0.7|-0.1|||MMRM|||Genital Symptoms, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.10|-0.70|0.0099
72427805|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.164||0.2174|TWO_SIDED|95.0|-0.53|0.12|||MMRM|||Genital Symptoms, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.12|-0.53|0.2174
72427806|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.28|STANDARD_ERROR_OF_MEAN|0.161||0.082|TWO_SIDED|95.0|-0.6|0.04|||MMRM|||Genital Symptoms, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.04|-0.60|0.0820
72337295|NCT02214225|144198371|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority criterion for the GMT ratio was that the upper bound of two-sided 95% CI on the ratio of Pooled TIV (for A strains) or TIV-1 (B Yamagata) or TIV-2 (B Victoria)/ bioCSL QIV should not exceed 1.5.|GMT ratio (B/VIC)|1.03|||||TWO_SIDED|95.0|0.94|1.14||||||For B/VIC strain. The GMT ratio (defined as the geometric mean of postvaccination (day 21) HI titer for TIV divided by the geometric mean of the postvaccination HI titer for QIV) for each virus strain included in the vaccines was determined: bioCSL TIV-1 and bioCSL TIV-2 GMTs were pooled for analysis of the A strains.||1.14|0.94|
72337296|NCT02214225|144198372|NON_INFERIORITY_OR_EQUIVALENCE|For A/H1N1. The non-inferiority criterion was that the upper bound of the two sided 95% CI on the difference between SCRs (Pooled TIV or TIV-1 (B Yamagata) or TIV-2 (B Victoria) minus bioCSL QIV) should not exceed 10%.|Difference in SCR (A/H1N1)|-2.1|||||TWO_SIDED|95.0|-6.9|2.6||||||The SCR difference was defined as the SCR percentage for bioCSL Pooled TIV or TIV-1 (B Yamagata) or TIV-2 (B Victoria) minus the SCR percentage for bioCSL QIV.||2.6|-6.9|
72337297|NCT02214225|144198372|NON_INFERIORITY_OR_EQUIVALENCE|For A/H3N2. The non-inferiority criterion was that the upper bound of the two sided 95% CI on the difference between SCRs (Pooled TIV or TIV-1 (B Yamagata) or TIV-2 (B Victoria) minus bioCSL QIV) should not exceed 10%.|Difference in SCR (A/H3N2)|-4.6|||||TWO_SIDED|95.0|-9.3|0.2||||||The SCR difference was defined as the SCR percentage for bioCSL Pooled TIV or TIV-1 (B Yamagata) or TIV-2 (B Victoria) minus the SCR percentage for bioCSL QIV.||0.2|-9.3|
72337298|NCT02214225|144198372|NON_INFERIORITY_OR_EQUIVALENCE|For B/YAM. The non-inferiority criterion was that the upper bound of the two sided 95% CI on the difference between SCRs (Pooled TIV or TIV-1 (B Yamagata) or TIV-2 (B Victoria) minus bioCSL QIV) should not exceed 10%.|Difference in SCR (B/YAM)|-4.5|||||TWO_SIDED|95.0|-10.3|1.3||||||The SCR difference was defined as the SCR percentage for bioCSL Pooled TIV or TIV-1 (B Yamagata) or TIV-2 (B Victoria) minus the SCR percentage for bioCSL QIV.||1.3|-10.3|
72337299|NCT02214225|144198372|NON_INFERIORITY_OR_EQUIVALENCE|For B/VIC. The non-inferiority criterion was that the upper bound of the two sided 95% CI on the difference between SCRs (Pooled TIV or TIV-1 (B Yamagata) or TIV-2 (B Victoria) minus bioCSL QIV) should not exceed 10%.|Difference in SCR (B/VIC)|-4.6|||||TWO_SIDED|95.0|-10.5|1.2||||||The SCR difference was defined as the SCR percentage for bioCSL Pooled TIV or TIV-1 (B Yamagata) or TIV-2 (B Victoria) minus the SCR percentage for bioCSL QIV.||1.2|-10.5|
72337300|NCT02214225|144198372|NON_INFERIORITY_OR_EQUIVALENCE|For A/H1N1. The non-inferiority criterion was that the upper bound of the two sided 95% CI on the difference between SCRs (Pooled TIV or TIV-1 (B Yamagata) or TIV-2 (B Victoria) minus bioCSL QIV) should not exceed 10%.|Difference in SCR (A/H1N1)|-0.2|||||TWO_SIDED|95.0|-4.4|4.0||||||The SCR difference was defined as the SCR percentage for bioCSL Pooled TIV or TIV-1 (B Yamagata) or TIV-2 (B Victoria) minus the SCR percentage for bioCSL QIV.||4.0|-4.4|
72337301|NCT02214225|144198372|NON_INFERIORITY_OR_EQUIVALENCE|For A/H3N2. The non-inferiority criterion was that the upper bound of the two sided 95% CI on the difference between SCRs (Pooled TIV or TIV-1 (B Yamagata) or TIV-2 (B Victoria) minus bioCSL QIV) should not exceed 10%.|Difference in SCR (A/H3N2)|1.1|||||TWO_SIDED|95.0|-3.1|5.2||||||The SCR difference was defined as the SCR percentage for bioCSL Pooled TIV or TIV-1 (B Yamagata) or TIV-2 (B Victoria) minus the SCR percentage for bioCSL QIV.||5.2|-3.1|
72337302|NCT02214225|144198372|NON_INFERIORITY_OR_EQUIVALENCE|For B/YAM. The non-inferiority criterion was that the upper bound of the two sided 95% CI on the difference between SCRs (Pooled TIV or TIV-1 (B Yamagata) or TIV-2 (B Victoria) minus bioCSL QIV) should not exceed 10%.|Difference in SCR (B/YAM)|-2.2|||||TWO_SIDED|95.0|-6.3|2.0||||||The SCR difference was defined as the SCR percentage for bioCSL Pooled TIV or TIV-1 (B Yamagata) or TIV-2 (B Victoria) minus the SCR percentage for bioCSL QIV.||2.0|-6.3|
72337303|NCT02214225|144198372|NON_INFERIORITY_OR_EQUIVALENCE|For B/VIC. The non-inferiority criterion was that the upper bound of the two sided 95% CI on the difference between SCRs (Pooled TIV or TIV-1 (B Yamagata) or TIV-2 (B Victoria) minus bioCSL QIV) should not exceed 10%.|Difference in SCR (B/VIC)|1.2|||||TWO_SIDED|95.0|-3.7|6.2||||||The SCR difference was defined as the SCR percentage for bioCSL Pooled TIV or TIV-1 (B Yamagata) or TIV-2 (B Victoria) minus the SCR percentage for bioCSL QIV.||6.2|-3.7|
72337304|NCT02214225|144198373|SUPERIORITY_OR_OTHER||GMT ratio (B/YAM) overall|1.47|||||TWO_SIDED|95.0|1.38|1.57|||||Immunologic superiority of the alternate B strain (eg, the influenza B strain included in the bioCSL QIV but not in the bioCSL TIV formulation) in bioCSL QIV was demonstrated if the lower bound of the two-sided 95% CI on GMT ratio was greater than 1.|Immunologic superiority of the alternate B strain (ie, the influenza B strain included in the QIV but not in the TIV formulation) in bioCSL QIV was assessed separately within each age group (18 to \< 65 years and ≥ 65 years of age), and overall. The GMT ratio was calculated as bioCSL QIV GMT/bioCSL TIV GMT for the superiority analyses, which is the reverse of how it was calculated for the non-inferiority analyses.||1.57|1.38|
72337305|NCT02214225|144198373|SUPERIORITY_OR_OTHER||GMT ratio (B/VIC) overall|1.57|||||TWO_SIDED|95.0|1.45|1.7|||||Immunologic superiority of the alternate B strain (eg, the influenza B strain included in the bioCSL QIV but not in the bioCSL TIV formulation) in bioCSL QIV was demonstrated if the lower bound of the two-sided 95% CI on GMT ratio was greater than 1.|Immunologic superiority of the alternate B strain (ie, the influenza B strain included in the QIV but not in the TIV formulation) in bioCSL QIV was assessed separately within each age group (18 to \< 65 years and ≥ 65 years of age), and overall. The GMT ratio was calculated as bioCSL QIV GMT/bioCSL TIV GMT for the superiority analyses, which is the reverse of how it was calculated for the non-inferiority analyses.||1.70|1.45|
72337306|NCT02214225|144198373|SUPERIORITY_OR_OTHER||GMT ratio (B/YAM) 18 through 64 years|1.67|||||TWO_SIDED|95.0|1.5|1.87|||||Immunologic superiority of the alternate B strain (eg, the influenza B strain included in the bioCSL QIV but not in the bioCSL TIV formulation) in bioCSL QIV was demonstrated if the lower bound of the two-sided 95% CI on GMT was greater than 1|Immunologic superiority of the alternate B strain (ie, the influenza B strain included in the QIV but not in the TIV formulation) in bioCSL QIV was assessed separately within each age group (18 to \< 65 years and ≥ 65 years of age), and overall. The GMT ratio was calculated as bioCSL QIV GMT/bioCSL TIV GMT for the superiority analyses, which is the reverse of how it was calculated for the non-inferiority analyses.||1.87|1.50|
72337307|NCT02214225|144198373|SUPERIORITY_OR_OTHER||GMT ratio (B/VIC) 18 through 64 years|1.76|||||TWO_SIDED|95.0|1.55|2.01|||||Immunologic superiority of the alternate B strain (eg, the influenza B strain included in the bioCSL QIV but not in the bioCSL TIV formulation) in bioCSL QIV was demonstrated if the lower bound of the two-sided 95% CI on GMT was greater than 1|Immunologic superiority of the alternate B strain (ie, the influenza B strain included in the QIV but not in the TIV formulation) in bioCSL QIV was assessed separately within each age group (18 to \< 65 years and ≥ 65 years of age), and overall. The GMT ratio was calculated as bioCSL QIV GMT/bioCSL TIV GMT for the superiority analyses, which is the reverse of how it was calculated for the non-inferiority analyses.||2.01|1.55|
72427807|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.22|STANDARD_ERROR_OF_MEAN|0.194||0.2642|TWO_SIDED|95.0|-0.6|0.17|||MMRM|||Genital Symptoms, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.17|-0.60|0.2642
72427808|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.34|STANDARD_ERROR_OF_MEAN|0.189||0.0718|TWO_SIDED|95.0|-0.72|0.03|||MMRM|||Genital Symptoms, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.03|-0.72|0.0718
72427809|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.22|STANDARD_ERROR_OF_MEAN|0.212||0.3055|TWO_SIDED|95.0|-0.64|0.2|||MMRM|||Genital Symptoms, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.20|-0.64|0.3055
72427810|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.19|STANDARD_ERROR_OF_MEAN|0.202||0.3533|TWO_SIDED|95.0|-0.59|0.21|||MMRM|||Genital Symptoms, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.21|-0.59|0.3533
72427811|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.15|STANDARD_ERROR_OF_MEAN|0.193||0.4514|TWO_SIDED|95.0|-0.53|0.24|||MMRM|||Genital Symptoms, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.24|-0.53|0.4514
72427812|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.13|STANDARD_ERROR_OF_MEAN|0.191||0.4907|TWO_SIDED|95.0|-0.51|0.25|||MMRM|||Genital Symptoms, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.25|-0.51|0.4907
72337308|NCT02214225|144198373|SUPERIORITY_OR_OTHER||GMT ratio (B/YAM) ≥ 65 years|1.3|||||TWO_SIDED|95.0|1.21|1.4|||||Immunologic superiority of the alternate B strain (eg, the influenza B strain included in the bioCSL QIV but not in the bioCSL TIV formulation) in bioCSL QIV was demonstrated if the lower bound of the two-sided 95% CI on GMT was greater than 1|Immunologic superiority of the alternate B strain (ie, the influenza B strain included in the QIV but not in the TIV formulation) in bioCSL QIV was assessed separately within each age group (18 to \< 65 years and ≥ 65 years of age), and overall. The GMT ratio was calculated as bioCSL QIV GMT/bioCSL TIV GMT for the superiority analyses, which is the reverse of how it was calculated for the non-inferiority analyses.||1.40|1.21|
72369876|NCT04881942|144250170|EQUIVALENCE|Null Hypothesis: Mean Total Puff Duration is equal to 0 Alternative Hypothesis: Mean Total Puff Duration is not equal to 0|Mean Difference (Final Values)|562.0|||<|0.0001|TWO_SIDED|95.0|401.34|722.67|||ANCOVA||LSM calculated from mixed models. Each model includes fixed effect terms for product, period and sequence.|Null Hypothesis: Mean Total Puff Duration is equal to 0 Alternative Hypothesis: Mean Total Puff Duration is not equal to 0||722.67|401.34|<.0001
72369877|NCT04881942|144250170|EQUIVALENCE|Null Hypothesis: Mean Total Puff Duration is equal to 0 Alternative Hypothesis: Mean Total Puff Duration is not equal to 0|Mean Difference (Final Values)|517.23|||<|0.0001|TWO_SIDED|95.0|356.11|678.34|||ANCOVA||LSM calculated from mixed models. Each model includes fixed effect terms for product, period and sequence.|Null Hypothesis: Mean Total Puff Duration is equal to 0 Alternative Hypothesis: Mean Total Puff Duration is not equal to 0||678.34|356.11|<.0001
72369878|NCT03860259|144250202|SUPERIORITY|||||||0.1771||||||P value less than 0.1 will be considered significant|t-test, 1 sided|||24 hrs||||0.1771
72369879|NCT03860259|144250202|SUPERIORITY|||||||0.2833||||||P value less than 0.1 will be considered significant|t-test, 1 sided|||48 hrs||||0.2833
72369880|NCT03860259|144250202|SUPERIORITY|||||||0.0909||||||P value less than 0.1 will be considered significant|t-test, 1 sided|||72 hrs||||0.0909
72369881|NCT03860259|144250202|SUPERIORITY|||||||0.231||||||P value less than 0.1 will be considered significant|t-test, 1 sided|||96 hrs||||0.2310
72369882|NCT03860259|144250202|SUPERIORITY|||||||0.0801|||||||t-test, 1 sided|||120 hrs||||0.0801
72369883|NCT03860259|144250202|SUPERIORITY|||||||0.0307||||||P value less than 0.1 will be considered significant|t-test, 1 sided|||Total||||0.0307
72369884|NCT03860259|144250203|SUPERIORITY|||||||0.1956||||||P value less than 0.1 will be considered significant|t-test, 1 sided|||24 hrs||||0.1956
72369885|NCT03860259|144250203|SUPERIORITY|||||||0.2274||||||P value less than 0.1 will be considered significant|t-test, 1 sided|||48 hrs||||0.2274
72369886|NCT03860259|144250203|SUPERIORITY|||||||0.109||||||P value less than 0.1 will be considered significant|t-test, 1 sided|||72 hrs||||0.1090
72369887|NCT03860259|144250203|SUPERIORITY|||||||0.1618||||||P value less than 0.1 will be considered significant|t-test, 1 sided|||96 hrs||||0.1618
72369888|NCT03860259|144250203|SUPERIORITY|||||||0.1264||||||P value less than 0.1 will be considered significant|t-test, 1 sided|||120 hrs||||0.1264
72369889|NCT03860259|144250203|SUPERIORITY|||||||0.0394||||||P value less than 0.1 will be considered significant|t-test, 1 sided|||Day 14||||0.0394
72369890|NCT03860259|144250203|SUPERIORITY|||||||0.3968||||||P value less than 0.1 will be considered significant|t-test, 1 sided|||Day 30||||0.3968
72369891|NCT03860259|144250203|SUPERIORITY|||||||0.3407||||||P value less than 0.1 will be considered significant|t-test, 1 sided|||Day 60||||0.3407
72369892|NCT03860259|144250203|SUPERIORITY|||||||0.4033||||||P value less than 0.1 will be considered significant|t-test, 1 sided|||Day 90||||0.4033
72369893|NCT03860259|144250204|SUPERIORITY|||||||0.1707||||||P value less than 0.1 will be considered significant|t-test, 1 sided|||Time of discharge||||0.1707
72369894|NCT03860259|144250204|SUPERIORITY|||||||0.3446||||||P value less than 0.1 will be considered significant|t-test, 1 sided|||24 hrs||||0.3446
72369895|NCT03860259|144250204|SUPERIORITY|||||||0.431|||||||t-test, 1 sided|||48 hrs||||0.4310
72369896|NCT03860259|144250204|SUPERIORITY|||||||0.3143||||||P value less than 0.1 will be considered significant|t-test, 1 sided|||72 hrs||||0.3143
72369897|NCT03860259|144250204|SUPERIORITY|||||||0.4749||||||P value less than 0.1 will be considered significant|t-test, 1 sided|||96 hrs||||0.4749
72369898|NCT03860259|144250204|SUPERIORITY|||||||0.3728||||||P value less than 0.1 will be considered significant|t-test, 1 sided|||120 hrs||||0.3728
72369899|NCT03860259|144250204|SUPERIORITY|||||||0.1628|||||||t-test, 1 sided|||Day 14||||0.1628
72369900|NCT03860259|144250204|SUPERIORITY|||||||0.0731||||||P value less than 0.1 will be considered significant|t-test, 1 sided|||Day 30||||0.0731
72369901|NCT03860259|144250204|SUPERIORITY|||||||0.4909||||||P value less than 0.1 will be considered significant|t-test, 1 sided|||Day 60||||0.4909
72369902|NCT03860259|144250204|SUPERIORITY|||||||0.4411||||||P value less than 0.1 will be considered significant|t-test, 1 sided|||Day 90||||0.4411
72369903|NCT03860259|144250205|SUPERIORITY|||||||0.1786||||||P value less than 0.1 will be considered significant|t-test, 1 sided|||Acetaminophen||||0.1786
72369904|NCT03860259|144250205|SUPERIORITY|||||||0.1876||||||P value less than 0.1 will be considered significant|t-test, 1 sided|||Ibuprofen||||0.1876
72369905|NCT03860259|144250206|SUPERIORITY|||||||0.3638||||||P value less than 0.1 will be considered significant|t-test, 1 sided|||Baseline PCS||||0.3638
72369906|NCT03860259|144250206|SUPERIORITY|||||||0.0856||||||P value less than 0.1 will be considered significant|t-test, 1 sided|||Day 14 PCS||||0.0856
72369907|NCT03860259|144250206|SUPERIORITY|||||||0.4428||||||P value less than 0.1 will be considered significant|t-test, 1 sided|||Day 30 PCS||||0.4428
72369908|NCT03860259|144250206|SUPERIORITY|||||||0.3378||||||P value less than 0.1 will be considered significant|t-test, 1 sided|||Day 60 PCS||||0.3378
72369909|NCT03860259|144250206|SUPERIORITY|||||||0.3942||||||P value less than 0.1 will be considered significant|t-test, 1 sided|||Day 90 PCS||||0.3942
72369910|NCT03860259|144250206|SUPERIORITY|||||||0.219||||||P value less than 0.1 will be considered significant|t-test, 1 sided|||Baseline MCS||||0.2190
72369911|NCT03860259|144250206|SUPERIORITY|||||||0.1112||||||P value less than 0.1 will be considered significant|t-test, 1 sided|||Day 14 MCS||||0.1112
72427813|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.06|STANDARD_ERROR_OF_MEAN|0.151||0.6949|TWO_SIDED|95.0|-0.36|0.24|||MMRM|||Hypochondriasis, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.24|-0.36|0.6949
72427814|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.11|STANDARD_ERROR_OF_MEAN|0.147||0.467|TWO_SIDED|95.0|-0.4|0.18|||MMRM|||Hypochondriasis, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.18|-0.40|0.4670
72427815|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.07|STANDARD_ERROR_OF_MEAN|0.16||0.6556|TWO_SIDED|95.0|-0.39|0.25|||MMRM|||Hypochondriasis, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.25|-0.39|0.6556
72427816|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.01|STANDARD_ERROR_OF_MEAN|0.156||0.9272|TWO_SIDED|95.0|-0.32|0.29|||MMRM|||Hypochondriasis, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.29|-0.32|0.9272
72427817|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.24|STANDARD_ERROR_OF_MEAN|0.164||0.1395|TWO_SIDED|95.0|-0.57|0.08|||MMRM|||Hypochondriasis, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.08|-0.57|0.1395
72427818|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.18|STANDARD_ERROR_OF_MEAN|0.159||0.2601|TWO_SIDED|95.0|-0.5|0.14|||MMRM|||Hypochondriasis, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.14|-0.50|0.2601
72427819|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.09|STANDARD_ERROR_OF_MEAN|0.158||0.5626|TWO_SIDED|95.0|-0.4|0.22|||MMRM|||Hypochondriasis, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.22|-0.40|0.5626
72427820|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.11|STANDARD_ERROR_OF_MEAN|0.153||0.4622|TWO_SIDED|95.0|-0.42|0.19|||MMRM|||Hypochondriasis, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.19|-0.42|0.4622
72427821|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.16|STANDARD_ERROR_OF_MEAN|0.151||0.2858|TWO_SIDED|95.0|-0.46|0.14|||MMRM|||Hypochondriasis, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.14|-0.46|0.2858
72427822|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.09|STANDARD_ERROR_OF_MEAN|0.146||0.5369|TWO_SIDED|95.0|-0.38|0.2|||MMRM|||Hypochondriasis, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.20|-0.38|0.5369
72427823|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.22|STANDARD_ERROR_OF_MEAN|0.15||0.151|TWO_SIDED|95.0|-0.52|0.08|||MMRM|||Hypochondriasis, Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.08|-0.52|0.1510
72427824|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.146||0.5107|TWO_SIDED|95.0|-0.38|0.19|||MMRM|||Hypochondriasis, Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.19|-0.38|0.5107
72427825|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.15|STANDARD_ERROR_OF_MEAN|0.151||0.3301|TWO_SIDED|95.0|-0.45|0.15|||MMRM|||Hypochondriasis, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.15|-0.45|0.3301
72427826|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.147||0.5139|TWO_SIDED|95.0|-0.39|0.19|||MMRM|||Hypochondriasis, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.19|-0.39|0.5139
72427827|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.12|STANDARD_ERROR_OF_MEAN|0.144||0.4073|TWO_SIDED|95.0|-0.4|0.17|||MMRM|||Hypochondriasis, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.17|-0.40|0.4073
72427828|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.14||0.4649|TWO_SIDED|95.0|-0.38|0.17|||MMRM|||Hypochondriasis, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.17|-0.38|0.4649
72427829|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.06|STANDARD_ERROR_OF_MEAN|0.141||0.6926|TWO_SIDED|95.0|-0.34|0.22|||MMRM|||Hypochondriasis, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.22|-0.34|0.6926
72427830|NCT02942004|144367030|SUPERIORITY||LS mean difference|0.05|STANDARD_ERROR_OF_MEAN|0.137||0.726|TWO_SIDED|95.0|-0.22|0.32|||MMRM|||Hypochondriasis, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.32|-0.22|0.7260
72427831|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.136||0.1486|TWO_SIDED|95.0|-0.47|0.07|||MMRM|||Hypochondriasis, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.07|-0.47|0.1486
72427832|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.09|STANDARD_ERROR_OF_MEAN|0.133||0.48|TWO_SIDED|95.0|-0.36|0.17|||MMRM|||Hypochondriasis, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.17|-0.36|0.4800
72427833|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.05|STANDARD_ERROR_OF_MEAN|0.177||0.7792|TWO_SIDED|95.0|-0.4|0.3|||MMRM|||Hypochondriasis, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.30|-0.40|0.7792
72427834|NCT02942004|144367030|SUPERIORITY||LS mean difference|0.03|STANDARD_ERROR_OF_MEAN|0.171||0.8644|TWO_SIDED|95.0|-0.31|0.37|||MMRM|||Hypochondriasis, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.37|-0.31|0.8644
72427835|NCT02942004|144367030|SUPERIORITY||LS mean difference|0.04|STANDARD_ERROR_OF_MEAN|0.158||0.7994|TWO_SIDED|95.0|-0.27|0.35|||MMRM|||Hypochondriasis, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.35|-0.27|0.7994
72427836|NCT02942004|144367030|SUPERIORITY||LS mean difference|0.27|STANDARD_ERROR_OF_MEAN|0.152||0.0811|TWO_SIDED|95.0|-0.03|0.57|||MMRM|||Hypochondriasis, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.57|-0.03|0.0811
72337309|NCT02214225|144198373|SUPERIORITY_OR_OTHER||GMT ratio (B/VIC) ≥ 65 years|1.38|||||TWO_SIDED|95.0|1.27|1.51|||||Immunologic superiority of the alternate B strain (eg, the influenza B strain included in the bioCSL QIV but not in the bioCSL TIV formulation) in bioCSL QIV was demonstrated if the lower bound of the two-sided 95% CI on GMT was greater than 1|Immunologic superiority of the alternate B strain (ie, the influenza B strain included in the QIV but not in the TIV formulation) in bioCSL QIV was assessed separately within each age group (18 to \< 65 years and ≥ 65 years of age), and overall. The GMT ratio was calculated as bioCSL QIV GMT/bioCSL TIV GMT for the superiority analyses, which is the reverse of how it was calculated for the non-inferiority analyses.||1.51|1.27|
72337310|NCT02214225|144198374|SUPERIORITY_OR_OTHER||Difference in SCR (B/YAM) overall|15.3|||||TWO_SIDED|95.0|12.1|18.6|||||Immunologic superiority of the alternate B strain (eg, the influenza B strain included in bioCSL QIV but not in the TIV formulation) in bioCSL QIV was demonstrated if the lower bound of the two-sided 95% CI for the difference in SCRs was \> 0.|Immunologic superiority of the alternate B strain (ie, the influenza B strain included in the QIV but not in the TIV formulation) in bioCSL QIV was assessed separately within each age group (18 to \< 65 years and ≥ 65 years of age), and overall. Seroconversion rate difference = bioCSL QIV SCR percentage - bioCSL TIV-1 or TIV-2 SCR percentage||18.6|12.1|
72427837|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.06|STANDARD_ERROR_OF_MEAN|0.144||0.6978|TWO_SIDED|95.0|-0.34|0.23|||MMRM|||Hypochondriasis, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.23|-0.34|0.6978
72427838|NCT02942004|144367030|SUPERIORITY||LS mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.141||0.9749|TWO_SIDED|95.0|-0.28|0.28|||MMRM|||Hypochondriasis, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.28|-0.28|0.9749
72427839|NCT02942004|144367030|SUPERIORITY||LS mean difference|0.08|STANDARD_ERROR_OF_MEAN|0.081||0.3158|TWO_SIDED|95.0|-0.08|0.24|||MMRM|||Loss of Weight, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.24|-0.08|0.3158
72427840|NCT02942004|144367030|SUPERIORITY||LS mean difference|0.1|STANDARD_ERROR_OF_MEAN|0.079||0.1901|TWO_SIDED|95.0|-0.05|0.26|||MMRM|||Loss of Weight, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.26|-0.05|0.1901
72427841|NCT02942004|144367030|SUPERIORITY||LS mean difference|0.03|STANDARD_ERROR_OF_MEAN|0.073||0.7229|TWO_SIDED|95.0|-0.12|0.17|||MMRM|||Loss of Weight, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.17|-0.12|0.7229
72427842|NCT02942004|144367030|SUPERIORITY||LS mean difference|0.08|STANDARD_ERROR_OF_MEAN|0.071||0.2715|TWO_SIDED|95.0|-0.06|0.22|||MMRM|||Loss of Weight, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.22|-0.06|0.2715
72337311|NCT02214225|144198374|SUPERIORITY_OR_OTHER||Difference in SCR (B/VIC) overall|20.1|||||TWO_SIDED|95.0|16.5|23.6|||||Immunologic superiority of the alternate B strain (eg, the influenza B strain included in bioCSL QIV but not in the TIV formulation) in bioCSL QIV was demonstrated if the lower bound of the two-sided 95% CI for the difference in SCRs was \> 0.|Seroconversion rate difference = bioCSL QIV SCR percentage - bioCSL TIV-1 or TIV-2 SCR percentage||23.6|16.5|
72427843|NCT02942004|144367030|SUPERIORITY||LS mean difference|0.05|STANDARD_ERROR_OF_MEAN|0.086||0.5421|TWO_SIDED|95.0|-0.12|0.22|||MMRM|||Loss of Weight, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.22|-0.12|0.5421
72427844|NCT02942004|144367030|SUPERIORITY||LS mean difference|0.03|STANDARD_ERROR_OF_MEAN|0.083||0.7215|TWO_SIDED|95.0|-0.14|0.19|||MMRM|||Loss of Weight, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.19|-0.14|0.7215
72427845|NCT02942004|144367030|SUPERIORITY||LS mean difference|0.12|STANDARD_ERROR_OF_MEAN|0.098||0.2246|TWO_SIDED|95.0|-0.07|0.31|||MMRM|||Loss of Weight, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.31|-0.07|0.2246
72337312|NCT02214225|144198374|SUPERIORITY_OR_OTHER||Difference in SCR (B/YAM) 18 through 64y|22.9|||||TWO_SIDED|95.0|17.7|28.2|||||Immunologic superiority of the alternate B strain (eg, the influenza B strain included in bioCSL QIV but not in the TIV formulation) in bioCSL QIV was demonstrated if the lower bound of the two-sided 95% CI for the difference in SCRs was \> 0.|Immunologic superiority of the alternate B strain (ie, the influenza B strain included in the QIV but not in the TIV formulation) in bioCSL QIV was assessed separately within each age group (18 to \< 65 years and ≥ 65 years of age), and overall. Seroconversion rate difference = bioCSL QIV SCR percentage - bioCSL TIV-1 or TIV-2 SCR percentage||28.2|17.7|
72337313|NCT02214225|144198374|SUPERIORITY_OR_OTHER||Difference in SCR (B/VIC) 18 through 64y|28.6|||||TWO_SIDED|95.0|23.1|34.1|||||Immunologic superiority of the alternate B strain (eg, the influenza B strain included in bioCSL QIV but not in the TIV formulation) in bioCSL QIV was demonstrated if the lower bound of the two-sided 95% CI for the difference in SCRs was \> 0.|Immunologic superiority of the alternate B strain (ie, the influenza B strain included in the QIV but not in the TIV formulation) in bioCSL QIV was assessed separately within each age group (18 to \< 65 years and ≥ 65 years of age), and overall. Seroconversion rate difference = bioCSL QIV SCR percentage - bioCSL TIV-1 or TIV-2 SCR percentage||34.1|23.1|
72337314|NCT02214225|144198374|SUPERIORITY_OR_OTHER||Difference in SCR (B/YAM) ≥ 65 years|8.0|||||TWO_SIDED|95.0|4.3|11.6|||||Immunologic superiority of the alternate B strain (eg, the influenza B strain included in bioCSL QIV but not in the TIV formulation) in bioCSL QIV was demonstrated if the lower bound of the two-sided 95% CI for the difference in SCRs was \> 0.|Immunologic superiority of the alternate B strain (ie, the influenza B strain included in the QIV but not in the TIV formulation) in bioCSL QIV was assessed separately within each age group (18 to \< 65 years and ≥ 65 years of age), and overall. Seroconversion rate difference = bioCSL QIV SCR percentage - bioCSL TIV-1 or TIV-2 SCR percentage||11.6|4.3|
72337315|NCT02214225|144198374|SUPERIORITY_OR_OTHER||Difference in SCR (B/VIC) ≥ 65 years|11.9|||||TWO_SIDED|95.0|7.7|16.0|||||Immunologic superiority of the alternate B strain (eg, the influenza B strain included in bioCSL QIV but not in the TIV formulation) in bioCSL QIV was demonstrated if the lower bound of the two-sided 95% CI for the difference in SCRs was \> 0.|Immunologic superiority of the alternate B strain (ie, the influenza B strain included in the QIV but not in the TIV formulation) in bioCSL QIV was assessed separately within each age group (18 to \< 65 years and ≥ 65 years of age), and overall. Seroconversion rate difference = bioCSL QIV SCR percentage - bioCSL TIV-1 or TIV-2 SCR percentage.||16.0|7.7|
72337316|NCT00434759|144198403|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.82|||<|0.05||95.0||||priori threshold for statistical significance is 0.05 p-value is not adjusted for multiple comparisons|ANOVA|We report the interaction effect.|The reported interaction effect is significant (p\< .05) in favour of standard therapy.|||||<0.05
72337317|NCT00434759|144198404|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.24|||<|0.05||95.0||||priori threshold for statistical significance is 0.05 p-value ist not adjusted for multiple comparisons|ANOVA|we report the interaction effect|The reported interaction effect is not significant.|||||<0.05
72337318|NCT00434759|144198405|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.99|||<|0.05||95.0||||p-value is not adjusted for multiple comparisons|ANOVA|we report the interaction effect|The reported interaction effect is not significant.|||||<0.05
72337319|NCT00434759|144198406|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.43|||<|0.05||95.0||||priori threshold for statistical significance is 0.05 p-value ist not adjusted for multiple comparisons|ANOVA|we report the interaction effect|The reported interaction is not significant.|||||<0.05
72337320|NCT00434759|144198407|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.86|||<|0.05||95.0||||priori threshold for statistical significance ist 0.05 p-value ist nor adjusted for multiple comparisons|ANOVA|we report the interaction effect|The reported interaction effect is significant (p \< .05) in favour of standard therapy|||||<0.05
72427846|NCT02942004|144367030|SUPERIORITY||LS mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.096||0.9671|TWO_SIDED|95.0|-0.19|0.19|||MMRM|||Loss of Weight, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.19|-0.19|0.9671
72427847|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.05|STANDARD_ERROR_OF_MEAN|0.121||0.6527|TWO_SIDED|95.0|-0.29|0.19|||MMRM|||Loss of Weight, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.19|-0.29|0.6527
72337321|NCT00997425|144198408|SUPERIORITY_OR_OTHER|||||||0.098|TWO_SIDED|||||values above 0.05 are considered statistically not significant in this study|paired t-test|statistical analysis applies to door approach behavior||||||0.098
72337322|NCT00997425|144198408|SUPERIORITY_OR_OTHER|||||||0.045|TWO_SIDED|||||P values above 0.05 are considered statistically not significant in this study|paired t-test|statistical analysis applies to door pass through behavior||||||0.045
72337323|NCT01300819|144198430|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.58||||0.147|TWO_SIDED|95.0|-8.43|1.26||Two-sided p-value is presented. No multiplicity adjustment is performed.|ANCOVA|Analysing was performed with ANCOVA model, adjusted for several terms.||Null hypothesis: mean change in the total Nonmotor Symptoms Scale (NMSS) score is the same for rotigotine- and placebo-treated group.||1.26|-8.43|0.147
72337324|NCT01300819|144198431|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.6||||0.002|TWO_SIDED|95.0|-4.27|-0.92||Two-sided p-value is presented. No multiplicity adjustment is performed.|ANCOVA|Analysis was performed with ANCOVA model, adjusted for several terms.||||-0.92|-4.27|0.002
72337325|NCT01300819|144198432|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.79||||0.024|TWO_SIDED|95.0|-5.21|-0.37||Two-sided p-values are presented.|ANCOVA|Testing was performed using an ANCOVA model, adjusted for several terms.||||-0.37|-5.21|0.024
72337326|NCT01300819|144198433|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.09||||0.773|TWO_SIDED|95.0|-0.67|0.5||Two-sided p-value is presented. No multiplicity adjustment is performed.|ANCOVA|Analysis was performed with ANCOVA model, adjusted for several terms.||||0.50|-0.67|0.773
72427848|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.17|STANDARD_ERROR_OF_MEAN|0.118||0.1647|TWO_SIDED|95.0|-0.4|0.07|||MMRM|||Loss of Weight, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.07|-0.40|0.1647
72369912|NCT03860259|144250206|SUPERIORITY|||||||0.1737||||||P value less than 0.1 will be considered significant|t-test, 1 sided|||Day 30 MCS||||0.1737
72427849|NCT02942004|144367030|SUPERIORITY||LS mean difference|0.04|STANDARD_ERROR_OF_MEAN|0.11||0.7093|TWO_SIDED|95.0|-0.18|0.26|||MMRM|||Loss of Weight, Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.26|-0.18|0.7093
72427850|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.05|STANDARD_ERROR_OF_MEAN|0.107||0.6333|TWO_SIDED|95.0|-0.26|0.16|||MMRM|||Loss of Weight, Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.16|-0.26|0.6333
72369913|NCT03860259|144250206|SUPERIORITY|||||||0.2408||||||P value less than 0.1 will be considered significant|t-test, 1 sided|||Day 60 MCS||||0.2408
72369914|NCT03860259|144250206|SUPERIORITY|||||||0.038||||||P value less than 0.1 will be considered significant|t-test, 1 sided|||Day 90 MCS||||0.0380
72369915|NCT03860259|144250207|SUPERIORITY|||||||0.222||||||P value less than 0.1 will be considered significant|t-test, 1 sided|||||||0.2220
72369916|NCT03860259|144250208|SUPERIORITY|||||||0.2856||||||P value less than 0.1 will be considered significant|t-test, 1 sided|||||||0.2856
72369917|NCT03860259|144250211|SUPERIORITY|||||||0.2241|||||||t-test, 1 sided|||||||0.2241
72369918|NCT03860259|144250212|SUPERIORITY|||||||0.2714||||||P value less than 0.1 will be considered significant|t-test, 1 sided|||Time of discharge||||0.2714
72369919|NCT03860259|144250212|SUPERIORITY|||||||0.3749||||||P value less than 0.1 will be considered significant|t-test, 1 sided|||24 hrs||||0.3749
72369920|NCT03860259|144250212|SUPERIORITY|||||||0.3862||||||P value less than 0.1 will be considered significant|t-test, 1 sided|||48 hrs||||0.3862
72369921|NCT03860259|144250212|SUPERIORITY|||||||0.1735||||||P value less than 0.1 will be considered significant|t-test, 1 sided|||72 hrs||||0.1735
72369922|NCT03860259|144250212|SUPERIORITY|||||||0.4304||||||P value less than 0.1 will be considered significant|t-test, 1 sided|||96 hrs||||0.4304
72369923|NCT03860259|144250212|SUPERIORITY|||||||0.4902||||||P value less than 0.1 will be considered significant|t-test, 1 sided|||120 hrs||||0.4902
72369924|NCT03860259|144250212|SUPERIORITY|||||||0.4371||||||P value less than 0.1 will be considered significant|t-test, 1 sided|||Day 14||||0.4371
72369925|NCT03860259|144250212|SUPERIORITY|||||||0.195||||||P value less than 0.1 will be considered significant|t-test, 1 sided|||Day 30||||0.1950
72369926|NCT03860259|144250212|SUPERIORITY|||||||0.4124|||||||t-test, 1 sided|||Day 60||||0.4124
72369927|NCT03860259|144250212|SUPERIORITY|||||||0.0268||||||P value less than 0.1 will be considered significant|t-test, 1 sided|||Day 90||||0.0268
72369928|NCT02280408|144250244|OTHER||||||<|0.001|||||||ANOVA|Adjustments for multiple comparisons were not performed.||||||<0.001
72369929|NCT02280408|144250244|OTHER||||||<|0.001|||||||ANOVA|Adjustments for multiple comparisons were not performed.||||||<0.001
72369930|NCT02280408|144250244|OTHER||||||<|0.001|||||||ANOVA|Adjustments for multiple comparisons were not performed.||||||<0.001
72369931|NCT02280408|144250244|OTHER|||||||0.01|||||||ANOVA|Adjustments for multiple comparisons were not performed.||||||0.010
72369932|NCT02280408|144250244|OTHER|||||||0.011|||||||ANOVA|Adjustments for multiple comparisons were not performed.||||||0.011
72369933|NCT02280408|144250244|OTHER|||||||0.969|||||||ANOVA|Adjustments for multiple comparisons were not performed||||||0.969
72369934|NCT02280408|144250245|OTHER||||||<|0.001|||||||ANOVA|Adjustments for multiple comparisons were not performed||||||<0.001
72369935|NCT02280408|144250245|OTHER||||||<|0.001|||||||ANOVA|Adjustments for multiple comparisons were not performed||||||<0.001
72369936|NCT02280408|144250245|OTHER||||||<|0.001|||||||ANOVA|Adjustments for multiple comparisons were not performed||||||<0.001
72369937|NCT02280408|144250245|OTHER||||||<|0.001|||||||ANOVA|Adjustments for multiple comparisons were not performed||||||<0.001
72369938|NCT02280408|144250245|OTHER||||||<|0.001|||||||ANOVA|Adjustments for multiple comparisons were not performed||||||<0.001
72369939|NCT02280408|144250245|OTHER|||||||0.733|||||||ANOVA|Adjustments for multiple comparisons were not performed||||||0.733
72369940|NCT02280408|144250246|OTHER||||||<|0.001|||||||ANOVA|Adjustments for multiple comparisons were not performed.||||||<0.001
72369941|NCT02280408|144250246|OTHER||||||<|0.001|||||||ANOVA|Adjustments for multiple comparisons were not performed.||||||<0.001
72369942|NCT02280408|144250246|OTHER||||||<|0.001|||||||ANOVA|Adjustments for multiple comparisons were not performed.||||||<0.001
72369943|NCT02280408|144250246|OTHER|||||||0.132|||||||ANOVA|Adjustments for multiple comparisons were not performed.||||||0.132
72369944|NCT02280408|144250246|OTHER|||||||0.07|||||||ANOVA|Adjustments for multiple comparisons were not performed.||||||0.070
72337327|NCT01300819|144198434|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.06||||0.122|TWO_SIDED|95.0|-2.41|0.29||Two-sided p-value is presented. No multiplicity adjustment is performed.|ANCOVA|Analysis was performed with ANCOVA model, adjusted for several terms.||||0.29|-2.41|0.122
72337328|NCT01300819|144198435|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.81||||0.047|TWO_SIDED|95.0|-3.59|-0.02||Two-sided p-value is presented. No multiplicity adjustment is performed.|ANCOVA|Analysis was performed with ANCOVA model, adjusted for several terms.||||-0.02|-3.59|0.047
72337329|NCT01300819|144198436|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.08||||0.601|TWO_SIDED|95.0|-0.22|0.37||Two-sided p-value is presented. No multiplicity adjustment is performed.|ANCOVA|Analysis was performed with ANCOVA model, adjusted for several terms.||||0.37|-0.22|0.601
72337330|NCT01300819|144198437|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.997|TWO_SIDED|95.0|-0.99|0.99||Two-sided p-value is presented. No multiplicity adjustment is performed.|ANCOVA|Analysis was performed with ANCOVA model, adjusted for several terms.||||0.99|-0.99|0.997
72337331|NCT01300819|144198438|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.19||||0.584|TWO_SIDED|95.0|-0.87|0.49||Two-sided p-value is presented. No multiplicity adjustment is performed.|ANCOVA|Analysis was performed with ANCOVA model, adjusted for several terms.||||0.49|-0.87|0.584
72337332|NCT01300819|144198439|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.38||||0.536|TWO_SIDED|95.0|-0.84|1.6||Two-sided p-value is presented. No multiplicity adjustment is performed.|ANCOVA|Analysis was performed with ANCOVA model, adjusted for several terms.||||1.60|-0.84|0.536
72337333|NCT01300819|144198440|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.06||||0.889|TWO_SIDED|95.0|-0.81|0.94||Two-sided p-value is presented. No multiplicity adjustment is performed.|ANCOVA|Analysis was performed with ANCOVA model, adjusted for several terms.||||0.94|-0.81|0.889
72337334|NCT01300819|144198441|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.04||||0.043|TWO_SIDED|95.0|-2.06|-0.03||Two-sided p-value is presented. No multiplicity adjustment is performed.|ANCOVA|Analysis was performed with ANCOVA model, adjusted for several terms.||||-0.03|-2.06|0.043
72337335|NCT01319721|144198456|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<0.05
72337336|NCT01319721|144198457|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Chi-squared|||||||<0.05
72337337|NCT01319721|144198458|SUPERIORITY_OR_OTHER|||||||0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.05
72337338|NCT01319721|144198459|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||t-test, 2 sided|||||||<0.05
72337339|NCT01319721|144198460|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<0.05
72337340|NCT00461305|144198461|SUPERIORITY_OR_OTHER||Incidence on one treatment arm|13.4|||||TWO_SIDED|95.0|9.73|17.77|||Binominal parameter by exact method||No group comparison were planned. Binomial parameter on each treatment arm was estimated by exact method.|Exact 95% confident intervals were calculated using F-distribution by treatment group. If the upper confidence limit is lower than 27.56% (threshold incidence), the treatment arm will be concluded to be acceptable. No group comparison was planned.||17.77|9.73|
72337341|NCT00461305|144198461|SUPERIORITY_OR_OTHER||Incidence on one treatment arm|7.1||||||95.0|1.98|17.29|||Binominal parameter by exact method|||Exact 95% confident intervals were calculated using F-distribution by treatment group.||17.29|1.98|
72337342|NCT00787930|144198507|SUPERIORITY_OR_OTHER||||||>|0.05||||||a priori threshold for significance was 0.05|Chi-squared|||||||>0.05
72337343|NCT00787930|144198508|SUPERIORITY_OR_OTHER|||||||1|||||||Chi-squared|df=1||||||1.00
72337344|NCT00787930|144198509|SUPERIORITY_OR_OTHER|||||||0.6056||||||No adjustment for multiple comparisons|Chi-squared|df=1||||||0.6056
72337345|NCT00787930|144198510|NON_INFERIORITY_OR_EQUIVALENCE|Exploratory hypothesis|t-stat estimated value|1.52|STANDARD_DEVIATION|8.2||0.081|ONE_SIDED|95.0|0.0||||t-test, 1 sided|missing values: 6 df=7|||||0|0.081
72337346|NCT00787930|144198511|NON_INFERIORITY_OR_EQUIVALENCE|Exploratory analyses|t-stat estimated value|1.47|STANDARD_DEVIATION|6.56||0.091|ONE_SIDED|95.0|0.0|||no adjustment for multiple analyses|t-test, 1 sided|missing values: 5 df=7|||||0|0.091
72337347|NCT04030247|144198523|OTHER|||||||0.03|||||||t-test, 2 sided|||Difference between baseline and month 3||||0.03
72337348|NCT04030247|144198524|OTHER|||||||0.16|||||||t-test, 2 sided|||Difference between baseline and month 3||||0.16
72337349|NCT04030247|144198525|OTHER|||||||0.03|||||||t-test, 2 sided|||Difference between baseline and month 3||||0.03
72337350|NCT04030247|144198526|OTHER|||||||0.9|||||||t-test, 2 sided|||Difference between baseline and month 3||||0.9
72337351|NCT04030247|144198527|OTHER|||||||0.5|||||||t-test, 2 sided|||Difference between baseline and month 3||||0.5
72337352|NCT04030247|144198528|OTHER|||||||0.4|||||||t-test, 2 sided|||Difference between baseline and month 3||||0.4
72337353|NCT04030247|144198530|OTHER|||||||0.6|||||||t-test, 2 sided|||Difference between baseline and month 3||||0.6
72337354|NCT04754230|144198584|OTHER|||||||0.8|||||||two sided Z-test|This estimate uses two sided Z-test while assuming type I error=0.05||Comparison of bleeding at day 1||||0.8
72337355|NCT01323270|144198623|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The non-inferiority criteria margin was 10%.|Percent difference|0.0|||||TWO_SIDED|95.0|-1.6|1.5||||||Diphtheria: Exact 2-sided confidence interval (based on Chan and Zhang) was reported for the difference in proportions, expressed as a percentage.||1.5|-1.6|
72337356|NCT01323270|144198623|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The non-inferiority criteria margin was 10%.|Percent difference|0.0|||||TWO_SIDED|95.0|-1.1|1.1||||||Tetanus: Exact 2-sided confidence interval (based on Chan and Zhang) was reported for the difference in proportions, expressed as a percentage.||1.1|-1.1|
72337357|NCT01323270|144198623|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The non-inferiority criteria margin was 10%.|Percent difference|-1.3|||||TWO_SIDED|95.0|-4.7|1.9||||||Pertussis toxoid: Exact 2-sided confidence interval (based on Chan and Zhang) was reported for the difference in proportions, expressed as a percentage.||1.9|-4.7|
72369945|NCT02280408|144250246|OTHER|||||||0.743|||||||ANOVA|Adjustments for multiple comparisons were not performed.||||||0.743
72369946|NCT02280408|144250247|OTHER||||||<|0.001|||||||ANOVA|Adjustments for multiple comparisons were not performed.||||||<0.001
72369947|NCT02280408|144250247|OTHER||||||<|0.001|||||||ANOVA|Adjustments for multiple comparisons were not performed.||||||<0.001
72369948|NCT02280408|144250247|OTHER||||||<|0.001|||||||ANOVA|Adjustments for multiple comparisons were not performed.||||||<0.001
72369949|NCT02280408|144250247|OTHER|||||||0.014|||||||ANOVA|Adjustments for multiple comparisons were not performed.||||||0.014
72369950|NCT02280408|144250247|OTHER|||||||0.011|||||||ANOVA|Adjustments for multiple comparisons were not performed.||||||0.011
72337358|NCT01323270|144198623|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The non-inferiority criteria margin was 10%.|Percent difference|0.0|||||TWO_SIDED|95.0|-1.1|1.1||||||Pertussis filamentous hemagglutinin: Exact 2-sided confidence interval (based on Chan and Zhang) was reported for the difference in proportions, expressed as a percentage.||1.1|-1.1|
72337359|NCT01323270|144198623|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The non-inferiority criteria margin was 10%.|Percent difference|0.0|||||TWO_SIDED|95.0|-1.1|1.1||||||Pertussis pertactin: Exact 2-sided confidence interval (based on Chan and Zhang) was reported for the difference in proportions, expressed as a percentage.||1.1|-1.1|
72337360|NCT01323270|144198623|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The non-inferiority criteria margin was 10%.|Percent difference|-1.2|||||TWO_SIDED|95.0|-3.6|0.8||||||Pertussis fimbrial agglutinogens types 2+3: Exact 2-sided confidence interval (based on Chan and Zhang) was reported for the difference in proportions, expressed as a percentage.||0.8|-3.6|
72337361|NCT01323270|144198623|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The non-inferiority criteria margin was 10%.|Percent difference|0.0|||||TWO_SIDED|95.0|-1.1|1.1||||||Poliovirus type 1: Exact 2-sided confidence interval (based on Chan and Zhang) was reported for the difference in proportions, expressed as a percentage.||1.1|-1.1|
72337362|NCT01323270|144198623|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The non-inferiority criteria margin was 10%.|Percent difference|0.0|||||TWO_SIDED|95.0|-1.1|1.1||||||Poliovirus type 2: Exact 2-sided confidence interval (based on Chan and Zhang) was reported for the difference in proportions, expressed as a percentage.||1.1|-1.1|
72337363|NCT01323270|144198623|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The non-inferiority criteria margin was 10%.|Percent difference|0.0|||||TWO_SIDED|95.0|-1.1|1.1||||||Poliovirus type 3: Exact 2-sided confidence interval (based on Chan and Zhang) was reported for the difference in proportions, expressed as a percentage.||1.1|-1.1|
72337364|NCT03242772|144198658|OTHER|||||||0.2664||||||Significance at \<0.05|95% confidence interval|confidence interval (CI) = -3.5729 - 11.6929|||Presentation of results will include p-values and 95% confidence intervals for the least mean square values at weeks 0, 10, 24 (week 24 is exploratory).|||0.2664
72337365|NCT03242772|144198659|OTHER|||||||0.3721||||||Significance at \<0.05|95% confidence interval|confidence interval (CI) = -17.7698 - 7.2698|||Presentation of results will include p-values and 95% confidence intervals for the least mean square values at weeks 0, 10, 24 (week 24 is exploratory).|||0.3721
72337366|NCT01310400|144198661|NON_INFERIORITY_OR_EQUIVALENCE|This study evaluated the non-inferiority of 0.5 mL Inflexal V and 0.25 mL Inflexal V in comparison to 0.25 mL Agrippal. Seroconversion rate was the primary endpoint. The difference in seroconversion rates between each Inflexal V and the control group was used for the evaluation of non-inferiority. If the lower limit of the 95% CI of this difference was greater than -10% for all 3 strains, the Inflexal V group was considered non-inferior to the control group.|Difference in seroconversion rates|4.5||||0.0036|TWO_SIDED|95.0|1.4|7.5||The significance level α = 0.05 (one-sided) was adjusted to α = 0.025 (one-sided) for the primary endpoint|Chi-squared|||This statistical anaylsis evaluated the non-inferiority of 0.5 mL Inflexal V vs. 0.25 mL Agrippal for the A/H1N1 strain.||7.5|1.4|0.0036
72337367|NCT01310400|144198661|NON_INFERIORITY_OR_EQUIVALENCE|This study evaluated the non-inferiority of 0.5 mL Inflexal V and 0.25 mL Inflexal V in comparison to 0.25 mL Agrippal. Seroconversion rate was the primary endpoint. The difference in seroconversion rates between each Inflexal V and the control group was used for the evaluation of non-inferiority. If the lower limit of the 95% CI of this difference was greater than -10% for all 3 strains, the Inflexal V group was considered non-inferior to the control group.|Difference in seroconversion rates|-3.0||||0.1465|TWO_SIDED|95.0|-7.0|1.0||The significance level α = 0.05 (one-sided) was adjusted to α = 0.025 (one-sided) for the primary endpoint|Chi-squared|||This statistical anaylsis evaluated the non-inferiority of 0.25 mL Inflexal V vs. 0.25 mL Agrippal for the A/H1N1 strain.||1.0|-7.0|0.1465
72337368|NCT01310400|144198661|NON_INFERIORITY_OR_EQUIVALENCE|This study evaluated the non-inferiority of 0.5 mL Inflexal V and 0.25 mL Inflexal V in comparison to 0.25 mL Agrippal. Seroconversion rate was the primary endpoint. The difference in seroconversion rates between each Inflexal V and the control group was used for the evaluation of non-inferiority. If the lower limit of the 95% CI of this difference was greater than -10% for all 3 strains, the Inflexal V group was considered non-inferior to the control group.|Difference in seroconversion rates|8.0|||<|0.001|TWO_SIDED|95.0|3.3|12.7||The significance level α = 0.05 (one-sided) was adjusted to α = 0.025 (one-sided) for the primary endpoint|Chi-squared|||This statistical anaylsis evaluated the non-inferiority of 0.5 mL Inflexal V vs. 0.25 mL Agrippal for the A/H3N2 strain.||12.7|3.3|<0.001
72337369|NCT01310400|144198661|NON_INFERIORITY_OR_EQUIVALENCE|This study evaluated the non-inferiority of 0.5 mL Inflexal V and 0.25 mL Inflexal V in comparison to 0.25 mL Agrippal. Seroconversion rate was the primary endpoint. The difference in seroconversion rates between each Inflexal V and the control group was used for the evaluation of non-inferiority. If the lower limit of the 95% CI of this difference was greater than -10% for all 3 strains, the Inflexal V group was considered non-inferior to the control group.|Difference in seroconversion rates|0.9||||0.7493|TWO_SIDED|95.0|-4.5|6.2||The significance level α = 0.05 (one-sided) was adjusted to α = 0.025 (one-sided) for the primary endpoint|Chi-squared|||This statistical anaylsis evaluated the non-inferiority of 0.25 mL Inflexal V vs. 0.25 mL Agrippal for the A/H3N2 strain.||6.2|-4.5|0.7493
72337370|NCT01310400|144198661|NON_INFERIORITY_OR_EQUIVALENCE|This study evaluated the non-inferiority of 0.5 mL Inflexal V and 0.25 mL Inflexal V in comparison to 0.25 mL Agrippal. Seroconversion rate was the primary endpoint. The difference in seroconversion rates between each Inflexal V and the control group was used for the evaluation of non-inferiority. If the lower limit of the 95% CI of this difference was greater than -10% for all 3 strains, the Inflexal V group was considered non-inferior to the control group.|Difference in seroconversion rates|20.2||||0|TWO_SIDED|95.0|13.5|27.0||The significance level α = 0.05 (one-sided) was adjusted to α = 0.025 (one-sided) for the primary endpoint|Chi-squared|||This statistical anaylsis evaluated the non-inferiority of 0.5 mL Inflexal V vs. 0.25 mL Agrippal for the B-strain.||27.0|13.5|0.0000
72369951|NCT02280408|144250247|OTHER|||||||0.923|||||||ANOVA|Adjustments for multiple comparisons were not performed.||||||0.923
72369952|NCT05300763|144250258|SUPERIORITY|Superiority was declared if the lower bound of the 2-sided 95% confidence interval is above 1.|Odds Ratio (OR)|2.01|||||TWO_SIDED|95.0|1.25|3.22|||Linear Mixed Model||Odds Ratio was calculated as Test over Control.|||3.22|1.25|
72369953|NCT05300763|144250259|SUPERIORITY|Superiority was declared if the lower bound of the 2-sided adjusted (96.25%) confidence interval is above 1.|Odds Ratio (OR)|2.0|||||TWO_SIDED|96.25|1.18|3.41|||Linear Mixed Model||Odds Ratio was calculated as Test over Control.|||3.41|1.18|
72337371|NCT01310400|144198661|NON_INFERIORITY_OR_EQUIVALENCE|This study evaluated the non-inferiority of 0.5 mL Inflexal V and 0.25 mL Inflexal V in comparison to 0.25 mL Agrippal. Seroconversion rate was the primary endpoint. The difference in seroconversion rates between each Inflexal V and the control group was used for the evaluation of non-inferiority. If the lower limit of the 95% CI of this difference was greater than -10% for all 3 strains, the Inflexal V group was considered non-inferior to the control group.|Difference in seroconversion rates|10.7||||0.0029|TWO_SIDED|95.0|3.7|17.6||The significance level α = 0.05 (one-sided) was adjusted to α = 0.025 (one-sided) for the primary endpoint|Chi-squared|||This statistical anaylsis evaluated the non-inferiority of 0.25 mL Inflexal V vs. 0.25 mL Agrippal for the B-strain.||17.6|3.7|0.0029
72337372|NCT01062841|144198665|SUPERIORITY_OR_OTHER||Rate Ratio|0.77|||<|0.05|TWO_SIDED|95.0|0.62|0.94||The model was adjusted for participant-specific covariates (participant-level baseline colonization with the specific MDRO, age, sex, race, and length of stay before enrollment), and NH quality ratings.|Regression, Poisson|||A mixed-effects multilevel Poisson regression model was used to predict MDRO prevalence density as a function of the intervention (primary outcome), including facility as a random effect and offset by the number of anatomic sites sampled. Because we expected participants colonized at baseline to have a greater likelihood of subsequent colonization, we included participant-level baseline MDRO colonization as a fixed effect.||0.94|0.62|<0.05
72337373|NCT01062841|144198666|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.54||||0.04|TWO_SIDED|95.0|0.3|0.97|||Regression, Cox|||A Cox proportional hazards model using the cluster option with robust standard errors was used to predict time to the first and recurrent infections, adjusting for participant-level and facility-level covariates.||0.97|0.30|0.04
72337374|NCT01062841|144198667|SUPERIORITY_OR_OTHER||Rate Ratio|0.78|||<|0.05|TWO_SIDED|95.0|0.64|0.96||The model was adjusted for participant-specific covariates (participant-level baseline colonization with the specific MDRO, age, sex, race, and length of stay before enrollment), and NH quality ratings.|Regression, Poisson|||A mixed-effects multilevel Poisson regression model was used to predict MDRO prevalence density as a function of the intervention (primary outcome), including facility as a random effect and offset by the number of anatomic sites sampled. Because we expected participants colonized at baseline to have a greater likelihood of subsequent colonization, we included participant-level baseline MDRO colonization as a fixed effect.||0.96|0.64|<0.05
72337375|NCT01062841|144198668|SUPERIORITY_OR_OTHER||Rate Ratio|1.2|||>|0.05|TWO_SIDED|95.0|0.82|1.75||The model was adjusted for participant-specific covariates (participant-level baseline colonization with the specific MDRO, age, sex, race, and length of stay before enrollment), and NH quality ratings.|Regression, Poisson|||A mixed-effects multilevel Poisson regression model was used to predict MDRO prevalence density as a function of the intervention (primary outcome), including facility as a random effect and offset by the number of anatomic sites sampled. Because we expected participants colonized at baseline to have a greater likelihood of subsequent colonization, we included participant-level baseline MDRO colonization as a fixed effect.||1.75|0.82|>0.05
72337376|NCT01062841|144198669|SUPERIORITY_OR_OTHER||Rate Ratio|0.94|||>|0.05|TWO_SIDED|95.0|0.61|1.44||The model was adjusted for participant-specific covariates (participant-level baseline colonization with the specific MDRO, age, sex, race, and length of stay before enrollment), and NH quality ratings.|Regression, Poisson|||A mixed-effects multilevel Poisson regression model was used to predict MDRO prevalence density as a function of the intervention (primary outcome), including facility as a random effect and offset by the number of anatomic sites sampled. Because we expected participants colonized at baseline to have a greater likelihood of subsequent colonization, we included participant-level baseline MDRO colonization as a fixed effect.||1.44|0.61|>0.05
72337377|NCT01062841|144198670|SUPERIORITY_OR_OTHER||Rate Ratio|0.75|||<|0.05|TWO_SIDED|95.0|0.58|0.97||The model was adjusted for participant-specific covariates (participant-level baseline colonization with the specific MDRO, age, sex, race, and length of stay before enrollment), and NH quality ratings.|Regression, Poisson|||A mixed-effects multilevel Poisson regression model was used to predict MDRO prevalence density as a function of the intervention (primary outcome), including facility as a random effect and offset by the number of anatomic sites sampled. Because we expected participants colonized at baseline to have a greater likelihood of subsequent colonization, we included participant-level baseline MDRO colonization as a fixed effect.||0.97|0.58|<0.05
72337378|NCT01062841|144198672|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.09||||0.92|TWO_SIDED|95.0|0.22|5.45|||Regression, Cox|||A Cox proportional hazards model using the cluster option with robust standard errors was used to predict time to the first and recurrent infections, adjusting for participant-level and facility-level covariates.||5.45|0.22|0.92
72337379|NCT01062841|144198673|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.83||||0.34|TWO_SIDED|95.0|0.53|6.31|||Regression, Cox|||A Cox proportional hazards model using the cluster option with robust standard errors was used to predict time to the first and recurrent infections, adjusting for participant-level and facility-level covariates.||6.31|0.53|0.34
72427851|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.08|STANDARD_ERROR_OF_MEAN|0.12||0.5238|TWO_SIDED|95.0|-0.31|0.16|||MMRM|||Loss of Weight, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.16|-0.31|0.5238
72337380|NCT01062841|144198674|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.78||||0.01|TWO_SIDED|95.0|0.65|0.95|||Regression, Cox|||A Cox proportional hazards model was used to evaluate the effect of this intervention on an individual's risk of new MDRO acquisition, defined as the number of residents with new acquisitions per 1000 device-days at risk after adjusting for resident-level and facility-level covariates, as well as clustering by facility. Residents colonized with the specific MDRO at baseline were excluded from these analyses.||0.95|0.65|0.01
72427852|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.21|STANDARD_ERROR_OF_MEAN|0.117||0.0782|TWO_SIDED|95.0|-0.44|0.02|||MMRM|||Loss of Weight, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.02|-0.44|0.0782
72337381|NCT01062841|144198675|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.85||||0.61|TWO_SIDED|95.0|0.45|1.6|||Regression, Cox|||A Cox proportional hazards model was used to evaluate the effect of this intervention on an individual's risk of new MDRO acquisition, defined as the number of residents with new acquisitions per 1000 device-days at risk after adjusting for resident-level and facility-level covariates, as well as clustering by facility. Residents colonized with the specific MDRO at baseline were excluded from these analyses.||1.60|0.45|0.61
72337382|NCT01062841|144198676|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.9||||0.59|TWO_SIDED|95.0|0.6|1.33|||Regression, Cox|||||1.33|0.60|0.59
72337383|NCT01118520|144198677|SUPERIORITY|||||||0.78|||||||Mixed Models Analysis|||||||0.78
72337384|NCT01118520|144198677|SUPERIORITY|||||||0.89|||||||Mixed Models Analysis|||||||0.89
72337385|NCT01089023|144198686|SUPERIORITY_OR_OTHER||||||<|0.0001||||||p-value measures the significance between each visit using analysis of variance|ANOVA|||||||<0.0001
72427853|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.16|STANDARD_ERROR_OF_MEAN|0.138||0.2346|TWO_SIDED|95.0|-0.44|0.11|||MMRM|||Loss of Weight, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.11|-0.44|0.2346
72337386|NCT01089023|144198687|SUPERIORITY_OR_OTHER||||||<|0.0001||||||p-value measures the significance between each visit using analysis of variance|ANOVA|||||||<0.0001
72337387|NCT02825966|144198710|EQUIVALENCE|The two one-sided t-test (TOST) was used to test equivalence. Using TOST, equivalence was established at α = 0.05 significance level if a (1-2α)\*100% confidence interval for the average difference in EMAT (WCD-AUDICOR) was contained within the interval \[-12, 12\].|Mean Difference (Final Values)|1.01|||<|0.001|TWO_SIDED|90.0|-2.89|4.69|||two one-sided test (TOST)|||First, the difference in EMAT between the LifeVest and AUDICOR device (first wear) was calculated for each subject. Then the mean and standard deviation of the differences in EMAT were calculated. The 2 devices were considered equivalent if the 90% confidence interval for mean difference in EMAT was within the pre-specified margin of \[-12, 12\] ms.||4.69|-2.89|< 0.001
72337388|NCT02680574|144198719|NON_INFERIORITY|Establishment of non-inferiority was based on a margin of -0.75 g/dL applied to the difference in mean change of hemoglobin: Vadadustat minus Darbepoetin alfa|Least squares mean difference|-0.01|STANDARD_ERROR_OF_MEAN|0.042|||TWO_SIDED|95.0|-0.09|0.07||||||Treatment comparison: Vadadustat minus Darbepoetin Alfa||0.07|-0.09|
72369954|NCT05300763|144250260|SUPERIORITY|Superiority was declared if the lower bound of the 2-sided adjusted (97.5 %) confidence interval is above 1.|Odds Ratio (OR)|2.17|||||TWO_SIDED|97.5|1.3|3.64|||Linear Mixed Model||Odds Ratio was calculated as Test over Control.|||3.64|1.30|
72369955|NCT05300763|144250261|SUPERIORITY|Superiority was declared if the lower bound of the 2-sided 95% confidence interval is above 1.|Odds Ratio (OR)|1.77|||||TWO_SIDED|95.0|1.04|3.02|||Linear Mixed Model||Odds Ratio was calculated as Test over Control.|||3.02|1.04|
72369956|NCT03563183|144250265|OTHER|Vaccine efficacy rate was calculated as 100\*(1-RR) with RR=relative risk of developing the confimed herpes zoster for Herpes Zoster subunit vaccine Group compared to Placebo Group.|Vaccine Efficacy rate|95.81|||<|0.0001|TWO_SIDED|95.0|91.58|98.22|||Poisson exact test|||Efficacy analysis aimed at comparing the confimed herpes zoster for Herpes Zoster incidence rate between Non-Frail-HZ/su vs Non-Frail-Placebo groups.||98.22|91.58|<0.0001
72369957|NCT03563183|144250265|OTHER|Vaccine efficacy rate was calculated as 100\*(1-RR) with RR=relative risk of developing the confimed herpes zoster for Herpes Zoster subunit vaccine group compared to placebo people.|Vaccine Efficacy rate|90.4|||<|0.0001|TWO_SIDED|95.0|84.41|94.43|||Poisson exact test|||Efficacy analysis aimed at comparing the confimed herpes zoster for Herpes Zoster incidence rate between Pre-Frail-HZ/su vs Pre-Frail-Placebo groups.||94.43|84.41|<0.0001
72369958|NCT03563183|144250265|OTHER|Vaccine efficacy rate was calculated as 100\*(1-RR) with RR=relative risk of developing the confimed herpes zoster for Herpes Zoster subunit vaccine group compared to placebo people.|Vaccine Efficacy rate|90.17|||<|0.0001|TWO_SIDED|95.0|75.36|96.65|||Poisson exact test|||Efficacy analysis aimed at comparing the confimed herpes zoster for Herpes Zoster incidence rate between Frail-HZ/su vs Frail-Placebo groups.||96.65|75.36|<0.0001
72369959|NCT03563183|144250265|OTHER|Vaccine efficacy rate was calculated as 100\*(1-RR) with RR=relative risk of developing the confimed herpes zoster for Herpes Zoster subunit vaccine group compared to placebo people.|Vaccine Efficacy rate|100.0||||0.069|TWO_SIDED|95.0|14.61|100.0|||Poisson exact test|||Efficacy analysis aimed at comparing the confimed herpes zoster for Herpes Zoster incidence rate between Unknown-HZ/su vs Unknown-Placebo groups.||100|14.61|0.069
72369960|NCT03563183|144250266|OTHER|VE against the BOI due to HZ (VE BOI ) was defined as the relative reduction in the BOI score in the vaccine group as compared with that in the placebo group and calculated as 1 - relative risk (i.e., 1- the HZ BOI score in the vaccine group divided by the HZ BOI score in the placebo group).|Vaccine Efficacy rate|98.6|||||TWO_SIDED|95.0|97.1|100.0||||||VE against confirmed HZ BOI and 95% confidence intervals (CIs) are presented by frailty status in the mTVC.||100|97.1|
72369961|NCT03563183|144250266|OTHER|VE against the BOI due to HZ (VE BOI ) was defined as the relative reduction in the BOI score in the vaccine group as compared with that in the placebo group and calculated as 1 - relative risk (i.e., 1- the HZ BOI score in the vaccine group divided by the HZ BOI score in the placebo group).|Vaccine Efficacy rate|92.6|||||TWO_SIDED|95.0|86.6|98.7||||||VE against confirmed HZ BOI and 95% confidence intervals (CIs) are presented by frailty status in the mTVC.||98.7|86.6|
72369962|NCT03563183|144250266|OTHER|VE against the BOI due to HZ (VE BOI ) was defined as the relative reduction in the BOI score in the vaccine group as compared with that in the placebo group and calculated as 1 - relative risk (i.e., 1- the HZ BOI score in the vaccine group divided by the HZ BOI score in the placebo group).|Vaccine Efficacy rate|85.2|||||TWO_SIDED|95.0|62.6|100.0||||||VE against confirmed HZ BOI and 95% confidence intervals (CIs) are presented by frailty status in the mTVC.||100|62.6|
72369963|NCT03563183|144250266|OTHER|VE against the BOI due to HZ (VE BOI ) was defined as the relative reduction in the BOI score in the vaccine group as compared with that in the placebo group and calculated as 1 - relative risk (i.e., 1- the HZ BOI score in the vaccine group divided by the HZ BOI score in the placebo group).|Vaccine Efficacy rate|100.0||||||||||||||VE against the BOI due to confirmed HZ. The 95% Confidence Interval was not calculated as there were no subjects reported with a confirmed Zoster episode in the Unknown-HZ/su Group.||||
72369964|NCT01594528|144250343|OTHER|||||||0.992||||||comparison between groups for body indicators|Wilcoxon (Mann-Whitney)|||||||0.992
72369965|NCT01594528|144250343|OTHER|||||||0.8||||||comparison between groups facial indicators|Wilcoxon (Mann-Whitney)|||||||0.8
72369966|NCT01594528|144250343|OTHER|||||||0.586||||||comparison between groups for vocal indicators|Wilcoxon (Mann-Whitney)|||||||0.586
72369967|NCT02100696|144250350|SUPERIORITY||Adjusted difference in response rates|12.2||||0.0033|TWO_SIDED|95.0|3.95|17.67|||Cochran-Mantel-Haenszel|||||17.67|3.95|0.0033
72369968|NCT02100696|144250351|SUPERIORITY||Treatment Difference|3.8||||0.4956|TWO_SIDED|95.0|-7.13|14.56|||Cochran-Mantel-Haenszel|||||14.56|-7.13|0.4956
72369969|NCT02100696|144250352|SUPERIORITY||Adjusted Difference in Remission Rates|12.5||||0.0028|TWO_SIDED|95.0|4.19|17.94||Nominal P-value reported (not adjusted for multiplicity)|Cochran-Mantel-Haenszel|||||17.94|4.19|0.0028
72369970|NCT02100696|144250353|SUPERIORITY||Adjusted Difference in Response Rates|14.3||||0.0241|TWO_SIDED|95.0|3.21|24.14||Multiplicity P-value reported (adjusted for multiplicity)|Cochran-Mantel-Haenszel|||||24.14|3.21|0.0241
72369971|NCT02100696|144250354|SUPERIORITY||Adjusted Difference in Response Rates|8.1||||0.1605|TWO_SIDED|95.0|-2.54|17.22||Multiplicity P-value reported (adjusted for multiplicity)|Cochran-Mantel-Haenszel|||||17.22|-2.54|0.1605
72337389|NCT02680574|144198720|NON_INFERIORITY|The prespecified non-inferiority margin was 1.25 (per Food and Drug Administration \[FDA\]) and 1.3 (per European Medicines Agency \[EMA\]).|Hazard Ratio (HR)|1.16|||=|0.2015|TWO_SIDED|95.0|0.93|1.446|||Log Rank|Based on non-parametric analysis.||Statistical analysis from study AKB-6548-CI-0015 has been reported in this section.||1.446|0.930|=0.2015
72337390|NCT02680574|144198720|NON_INFERIORITY|The prespecified non-inferiority margin was 1.25 (per FDA) and 1.3 (per EMA).|Hazard Ratio (HR)|1.17|||=|0.0725|TWO_SIDED|95.0|1.012|1.355|||Log Rank|Based on non-parametric analysis.||MACE analysis was performed on pooled data from studies AKB-6548-CI-0014 (NCT02648347) and AKB-6548-CI-0015 (NCT02680574). Time to first MACE for the Vadadustat and Darbepoetin alfa treatment groups was as follows: participants with events = 382 and 344 respectively; median time to first event (Q1, Q3) = 50.07 (23.00, 82.86) weeks versus 51.93 (27.79, 91.00) weeks, respectively. Statistical analysis from the pooled data has been reported in this section.||1.355|1.012|=0.0725
72337391|NCT02680574|144198721|NON_INFERIORITY|Establishment of non-inferiority was based on a margin of -0.75 g/dL applied to the difference in mean change: Vadadustat minus Darbepoetin alfa.|Least squares mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.05|||TWO_SIDED|95.0|-0.1|0.09||||||Treatment comparison: Vadadustat minus Darbepoetin Alfa||0.09|-0.10|
72337392|NCT02680574|144198722|NON_INFERIORITY|The prespecified non-inferiority margin was 1.25 (per FDA) and 1.3 (per EMA).|Hazard Ratio (HR)|1.04|||=|0.777|TWO_SIDED|95.0|0.851|1.268|||Log Rank|Based on non-parametric analysis.||Statistical analysis from study AKB-6548-CI-0015 has been reported in this section.||1.268|0.851|=0.7770
72337393|NCT02680574|144198722|NON_INFERIORITY|The prespecified non-inferiority margin was 1.25 (per FDA) and 1.3 (per EMA).|Hazard Ratio (HR)|1.11|||=|0.2305|TWO_SIDED|95.0|0.972|1.267|||Log Rank|Based on non-parametric analysis.||MACE analysis was performed on pooled data from studies AKB-6548-CI-0014 (NCT02648347) and AKB-6548-CI-0015 (NCT02680574). Time to first MACE plus hospitalization for heart failure or thromboembolic events excluding vascular access thrombosis for the Vadadustat and Darbepoetin alfa treatment groups was as follows: participants with events = 451 and 424 respectively; median time to first event (Q1, Q3) = 42.86 (19.71, 73.43) weeks versus 43.86 (21.36, 80.43) weeks, respectively.||1.267|0.972|=0.2305
72337394|NCT02680574|144198723|NON_INFERIORITY|The prespecified non-inferiority margin was 1.25 (per FDA) and 1.3 (per EMA).|Hazard Ratio (HR)|1.11|||=|0.5509|TWO_SIDED|95.0|0.817|1.501|||Gray's Test|Based on non-parametric analysis.||Statistical analysis from study AKB-6548-CI-0015 has been reported in this section.||1.501|0.817|=0.5509
72337395|NCT02680574|144198723|NON_INFERIORITY|The prespecified non-inferiority margin was 1.25 (per FDA) and 1.3 (per EMA).|Hazard Ratio (HR)|1.16|||=|0.2531|TWO_SIDED|95.0|0.947|1.42|||Gray's Test|Based on non-parametric analysis.||MACE analysis was performed on pooled data from studies AKB-6548-CI-0014 (NCT02648347) and AKB-6548-CI-0015 (NCT02680574). Time to first cardiovascular MACE for the Vadadustat and Darbepoetin alfa treatment groups was as follows: participants with events = 198 and 178 respectively; median time to first event (Q1, Q3) = 45.57 (21.71, 73.29) weeks versus 47.36 (20.00, 88.43) weeks, respectively. Statistical analysis from the pooled data has been reported in this section.||1.420|0.947|=0.2531
72337396|NCT02680574|144198724|NON_INFERIORITY|The prespecified non-inferiority margin was 1.25 (per FDA) and 1.3 (per EMA).|Hazard Ratio (HR)|0.88|||=|0.4184|TWO_SIDED|95.0|0.61|1.258|||Gray's test|Based on non-parametric analysis.||Statistical analysis from study AKB-6548-CI-0015 has been reported in this section.||1.258|0.610|=0.4184
72369972|NCT02100696|144250355|SUPERIORITY||Adjusted Difference in Remission Rates|7.6||||0.3881|TWO_SIDED|95.0|-1.22|13.66||Multiplicity P-value reported (adjusted for multiplicity)|Cochran-Mantel-Haenszel|||||13.66|-1.22|0.3881
72369973|NCT02100696|144250356|SUPERIORITY||Adjusted Difference in Remission Rates|4.9||||0.5879|TWO_SIDED|95.0|-6.78|14.69||Multiplicity P-value reported (adjusted for multiplicity)|Cochran-Mantel-Haenszel|||||14.69|-6.78|0.5879
72369974|NCT02100696|144250357|SUPERIORITY||Difference in Unadjusted Means|-0.2||||0.0351|TWO_SIDED|95.0|-0.5|0.0||Multiplicity P-value reported (adjusted for multiplicity)|ANCOVA|||||-0.0|-0.5|0.0351
72369975|NCT02100696|144250358|SUPERIORITY||Difference in Unadjusted Means|-0.2||||0.2698|TWO_SIDED|95.0|-0.4|0.1||Multiplicity P-value reported (adjusted for multiplicity)|ANCOVA|||||0.1|-0.4|0.2698
72369976|NCT02100696|144250359|SUPERIORITY||Difference in Least Square Means|-1.6||||0.2698|TWO_SIDED|95.0|-2.9|-0.3||Multiplicity P-value reported (adjusted for multiplicity)|Mixed Models Analysis|||||-0.3|-2.9|0.2698
72369977|NCT02100696|144250360|SUPERIORITY||Difference in Least Square Means|-0.5||||0.3881|TWO_SIDED|95.0|-1.0|0.0||Multiplicity P-value reported (adjusted for multiplicity)|Mixed Models Analysis|||||0.0|-1.0|0.3881
72369978|NCT02100696|144250361|SUPERIORITY||Difference in Adjusted Means|9.1||||0.0445|TWO_SIDED|95.0|0.2|17.9||Nominal P-value reported (not adjusted for multiplicity)|ANCOVA|||||17.9|0.2|0.0445
72369979|NCT02100696|144250362|SUPERIORITY||Adjusted Difference in Remission Rates|0.1||||0.9959|TWO_SIDED|95.0|-19.67|19.88||Nominal P-value reported (not adjusted for multiplicity)|Cochran-Mantel-Haenszel|||||19.88|-19.67|0.9959
72369980|NCT02100696|144250363|SUPERIORITY||Adjusted Difference in Remission Rates|3.8||||0.5014|TWO_SIDED|95.0|-7.26|14.7||Nominal P-value reported (not adjusted for multiplicity)|Cochran-Mantel-Haenszel|||||14.70|-7.26|0.5014
72369981|NCT02100696|144250364|SUPERIORITY||Adjusted Difference in Remission Rates|0.6||||0.9538|TWO_SIDED|95.0|-19.08|20.35||Nominal P-value reported (not adjusted for multiplicity)|Cochran-Mantel-Haenszel|||||20.35|-19.08|0.9538
72369982|NCT02100696|144250365|SUPERIORITY||Adjusted Difference in Response Rates|14.5||||0.0153|TWO_SIDED|95.0|2.66|25.78||Nominal P-value reported (not adjusted for multiplicity)|Cochran-Mantel-Haenszel|||||25.78|2.66|0.0153
72369983|NCT02100696|144250366|SUPERIORITY||Adjusted Difference in Remission Rates|16.8||||0.0073|TWO_SIDED|95.0|4.44|28.41||Nominal P-value reported (not adjusted for multiplicity)|Cochran-Mantel-Haenszel|||||28.41|4.44|0.0073
72369984|NCT02100696|144250367|SUPERIORITY||Adjusted Difference in Remission Rates|11.9||||0.0174|TWO_SIDED|95.0|1.87|21.71||Nominal P-value reported (not adjusted for multiplicity)|Cochran-Mantel-Haenszel|||||21.71|1.87|0.0174
72369985|NCT02100696|144250368|SUPERIORITY||Adjusted Difference in Remission Rates|7.3||||0.3015|TWO_SIDED|95.0|-6.83|21.6||Nominal P-value reported (not adjusted for multiplicity)|Cochran-Mantel-Haenszel|||||21.60|-6.83|0.3015
72369986|NCT02100696|144250369|SUPERIORITY||Adjusted Difference in Remission Rates|7.4||||0.2787|TWO_SIDED|95.0|-6.23|21.17||Nominal P-value reported (not adjusted for multiplicity)|Cochran-Mantel-Haenszel|||||21.17|-6.23|0.2787
72337397|NCT02680574|144198724|NON_INFERIORITY|The prespecified non-inferiority margin was 1.25 (per FDA) and 1.3 (per EMA).|Hazard Ratio (HR)|1.01|||=|0.8613|TWO_SIDED|95.0|0.792|1.293|||Gray's test|Based on non-parametric analysis.||MACE analysis was performed on pooled data from studies AKB-6548-CI-0014 (NCT02648347) and AKB-6548-CI-0015 (NCT02680574). Time to first cardiovascular death for the Vadadustat and Darbepoetin alfa treatment groups was as follows: participants with events = 127 and 131 respectively; median time to first event (Q1, Q3) = 48.29 (28.86, 76.14) weeks versus 48.43 (21.29, 92.29) weeks, respectively. Statistical analysis from the pooled data has been reported in this section.||1.293|0.792|=0.8613
72337398|NCT02680574|144198725|NON_INFERIORITY|The prespecified non-inferiority margin was 1.25 (per FDA) and 1.3 (per EMA).|Hazard Ratio (HR)|1.04|||=|0.8041|TWO_SIDED|95.0|0.82|1.315|||Log Rank|Based on non-parametric analysis.||Statistical analysis from study AKB-6548-CI-0015 has been reported in this section.||1.315|0.820|=0.8041
72337399|NCT02680574|144198725|NON_INFERIORITY|The prespecified non-inferiority margin was 1.25 (per FDA) and 1.3 (per EMA).|Hazard Ratio (HR)|1.09|||=|0.4577|TWO_SIDED|95.0|0.93|1.274|||Log Rank|||MACE analysis was performed on pooled data from studies AKB-6548-CI-0014 (NCT02648347) and AKB-6548-CI-0015 (NCT02680574). Time to first all-cause mortality for the Vadadustat and Darbepoetin alfa treatment groups was as follows: participants with events = 319 and 307 respectively; median time to first event (Q1, Q3) = 52.14 (28.71, 84.71) weeks versus 53.00 (30.71, 94.14) weeks, respectively. Statistical analysis from the pooled data has been reported in this section.||1.274|0.930|=0.4577
72337400|NCT02847858|144198736|SUPERIORITY||Slope|1.16||||0.011|TWO_SIDED|95.0|0.26|2.07||Arm by Time interaction; a priori threshold for statistical significance p\<.05|Mixed Models Analysis|Adjusted for age, purpose of visit, and whether sexually active prior 3 months; random intercepts and slopes over time; clustering by recruitment site|Arm comparison is Arm 1 (Intervention) minus Arm2 (Control); Time comparison is Post-visit Follow-up minus Baseline|Null hypothesis: No difference between study arms in change in mean self-efficacy from Baseline to Post-visit Follow-up||2.07|0.26|0.011
72337401|NCT02847858|144198736|SUPERIORITY||Slope|1.64|||<|0.001|TWO_SIDED|95.0|1.01|2.07||Post hoc comparison pursuant to significant Arm by Time interaction; a priori threshold for statistical significance p\<.05|Mixed Models Analysis|Adjusted for age, purpose of visit, and whether sexually active prior 3 months; random intercepts and slopes over time; clustering by recruitment site|Time comparison is Post-visit Follow-up minus Baseline|Null hypothesis: No Time difference (Post-visit Follow-up vs. Baseline) in outcome||2.07|1.01|<0.001
72337402|NCT02847858|144198736|SUPERIORITY||Slope|0.48||||0.108|TWO_SIDED|95.0|-0.1|1.05||Post hoc comparison pursuant to significant Arm by Time interaction; a priori threshold for statistical significance p\<.05|Mixed Models Analysis|Adjusted for age, purpose of visit, and whether sexually active prior 3 months; random intercepts and slopes over time; clustering by recruitment site|Time comparison is Post-visit Follow-up minus Baseline|Null hypothesis: No Time difference (Post-visit Follow-up vs. Baseline) in outcome||1.05|-0.10|0.108
72337403|NCT02847858|144198737|SUPERIORITY||F statistic:Time X Arm Interaction|3.23||||0.04|TWO_SIDED|||||Arm by Time interaction; a priori threshold for statistical significance p\<.05|Mixed Models Analysis|Adjusted for age, purpose of visit, and whether sexually active prior 3 months; random intercepts and slopes over time; clustering by recruitment site|df=2,1611; Arm comparison is Intervention - Control; Time comparisons are 3 months - Baseline and 6 months - Baseline and 6 months - 3 months|Null hypothesis: No difference between study arms in change in mean self-efficacy from Baseline to 3 months or from Baseline to 6 months||||0.04
72337404|NCT02847858|144198737|SUPERIORITY||Slope|0.82||||0.218|TWO_SIDED|95.0|-0.48|2.11||Post hoc comparison pursuant to significant Arm by Time interaction; a priori threshold for statistical significance p\<.05|Mixed Models Analysis|Adjusted for age, purpose of visit, and whether sexually active prior 3 months; random intercepts and slopes over time; clustering by recruitment site||Null hypothesis: No difference between study arms in change in mean self-efficacy from Baseline to 3 months|Arm comparison is Intervention - Control; Time comparison is 3 months - Baseline|2.11|-0.48|.218
72337405|NCT02847858|144198737|SUPERIORITY||Slope|1.58||||0.008|TWO_SIDED|95.0|0.38|2.77||Post hoc comparison pursuant to significant Arm by Time interaction; a priori threshold for statistical significance p\<.05|Mixed Models Analysis|Adjusted for age, purpose of visit, and whether sexually active prior 3 months; random intercepts and slopes over time; clustering by recruitment site|Arm comparison is Intervention - Control; Time comparison is 6 months - Baseline|Null hypothesis: No difference between study arms in change in mean self-efficacy from Baseline to 6 months||2.77|0.38|0.008
72337406|NCT02847858|144198738|SUPERIORITY||F statistic:Time X Arm Interaction|3.72||||0.025|TWO_SIDED|||||Arm by Time Interaction; a priori threshold for statistical significance p\<.05|Mixed Models Analysis|Adjusted for age, purpose of visit, and whether sexually active prior 3 months; random intercepts and slopes over time; clustering by recruitment site|df=2, 1007; Arm comparison is Intervention/Control; Time comparisons are 3 months/Baseline and 6 months/Baseline and 6 months/3 months|Null hypothesis: No difference between arms in change in percentage of participants using non-barrier method from Baseline to 3 months or to 6 months||||0.025
72337407|NCT02847858|144198738|SUPERIORITY||Odds Ratio (OR)|3.29||||0.042|TWO_SIDED|95.0|1.04|10.36||Post hoc comparison pursuant to significant Arm by Time Interaction; a priori threshold for statistical significance p\<.05|Mixed Models Analysis|Adjusted for age, purpose of visit, and whether sexually active prior 3 months; random intercepts and slopes over time; clustering by recruitment site|Arm comparison is Intervention / Control; Time comparison is 3 months / Baseline|Null hypothesis: No difference between arms in change in percentage of participants using non-barrier method from Baseline to 3 months||10.36|1.04|0.042
72337408|NCT02847858|144198738|SUPERIORITY||Odds Ratio (OR)|5.54||||0.005|TWO_SIDED|95.0|1.7|18.06||Post hoc comparison pursuant to significant Arm by Time Interaction; a priori threshold for statistical significance p\<.05|Mixed Models Analysis|Adjusted for age, purpose of visit, and whether sexually active prior 3 months; random intercepts and slopes over time; clustering by recruitment site|Arm comparison is Intervention / Control; Time comparison is 6 months / Baseline|Null hypothesis: No difference between arms in change in percentage of participants using non-barrier method from Baseline to 6 months||18.06|1.7|0.005
72369987|NCT02100696|144250370|SUPERIORITY||Difference in Least Square Means|-1.5||||0.0763|TWO_SIDED|95.0|-3.1|0.2||Nominal P-value reported (not adjusted for multiplicity)|Mixed Models Analysis|||||0.2|-3.1|0.0763
72369988|NCT02100696|144250371|SUPERIORITY||Difference in Least Square Means|-0.2||||0.5329|TWO_SIDED|95.0|-1.0|0.5||Nominal P-value reported (not adjusted for multiplicity)|Mixed Models Analysis|||||0.5|-1.0|0.5329
72337409|NCT02847858|144198739|SUPERIORITY||Slope|1.62|||<|0.001|TWO_SIDED|95.0|1.43|1.82||Time main effect; a priori threshold for statistical significance p \<.05|Mixed Models Analysis|Adjusted for age, purpose of visit, and whether sexually active prior 3 months; random intercepts and slopes over time; clustering by recruitment site|Time comparison is post-app minus pre-app|Null hypothesis: No change in contraception knowledge from immediate pre-app to immediate post-app among Intervention group participants||1.82|1.43|<0.001
72337410|NCT02847858|144198740|SUPERIORITY||Odds Ratio (OR)|2.22||||0.055|TWO_SIDED|95.0|0.98|5.01||Arm main effect; a priori threshold for statistical significance p\<.05|Regression, Logistic|Adjusted for age, purpose of visit, and whether sexually active prior 3 months; clustering by recruitment site|Arm comparison is Arm 1 (Intervention) / Arm2 (Control)|Null hypothesis: No difference between study arms in percentage of participants who discussed birth control with health care provider at visit||5.01|0.98|0.055
72337411|NCT02847858|144198741|SUPERIORITY||Odds Ratio (OR)|1.66||||0.227|TWO_SIDED|95.0|0.73|3.78||Arm main effect; a priori threshold for statistical significance p\<.05|Regression, Logistic|Adjusted for age, purpose of visit, and whether sexually active prior 3 months; clustering by recruitment site|Arm comparison is Arm 1 (Intervention) / Arm2 (Control)|Null hypothesis: No difference between study arms in percentage of participants who receive/make appointment/get prescription for a non-barrier method||3.78|0.73|0.227
72337412|NCT00681564|144198816|SUPERIORITY_OR_OTHER|||||||0.98||||||A P value of 0.05 was used as a cut-off for statistical significance.|Kruskal-Wallis|Non-parametric test appropriate for the analysis of non-normally distributed data.||Analyzed variable: Brachial Artery Flow-mediated Dilation (baseline). Note: data analysis of patients who completed the study protocol (n=86). Intention-to-treat analysis analysis was not used because its application for the evaluation of continuous data would imply imputing missing data for patients lost to follow-up. Mean and standard deviation of flow-mediated dilatation, including data from all patients randomized in this study, is reported in the field of baseline characteristics.||||0.98
72337413|NCT00681564|144198816|SUPERIORITY_OR_OTHER|||||||0.005||||||A P value of 0.05 was used as a cut-off for statistical significance.|Kruskal-Wallis|Non-parametric test appropriate for the analysis of non-normally distributed data.||Analyzed variable: Brachial Artery Flow-mediated Dilation (24 hours).||||0.005
72337414|NCT00681564|144198816|SUPERIORITY_OR_OTHER|||||||0.43||||||A P value of 0.05 was used as a cut-off for statistical significance.|Kruskal-Wallis|Non-parametric test appropriate for the analysis of non-normally distributed data.||"Statistical analysis: Brachial Artery Flow-mediated Dilation (12 weeks). Intention-to-treat analysis was not used because input of values for patients lost at follow-up will artificially amplify the precision of outcome measures.~Higgins JPT, Deeks JJ, Altman DG (editors). Chapter 16: Special topics in statistics. In: Higgins JPT, Green S (editors). Cochrane Handbook for Systematic Reviews of Interventions. Version 5.0.1. The Cochrane Collaboration, 2008. www.cochrane-handbook.org."||||0.43
72337415|NCT02305849|144198857|SUPERIORITY||Percent Difference|36.9|||<|0.001|TWO_SIDED|95.0|26.7|47.0||Closed testing procedure was used for multiplicity adjustment.|Fisher Exact||CI was based on normal approximation to the binomial distribution.|Treatment Difference vs Placebo||47.0|26.7|<0.001
72337416|NCT02305849|144198857|SUPERIORITY||Percent difference|42.6|||<|0.001|TWO_SIDED|95.0|32.6|52.6||Closed testing procedure was used for multiplicity adjustment.|Fisher Exact||CI was based on normal approximation to the binomial distribution.|Treatment Difference vs Placebo||52.6|32.6|<0.001
72337417|NCT02305849|144198858|SUPERIORITY||||||<|0.001||||||Closed testing procedure was used for multiplicity adjustment.|RANCOVA|Based on Rank Analysis of Covariance (RANCOVA) Model: Rank of mTSS Change = Treatment + Baseline Rank of mTSS.||Treatment Difference vs Placebo||||<0.001
72337418|NCT02305849|144198858|SUPERIORITY||||||<|0.001||||||Closed testing procedure was used for multiplicity adjustment.|RANCOVA|Based on RANCOVA Model: Rank of mTSS Change = Treatment + Baseline Rank of mTSS.||Treatment Difference vs Placebo||||<0.001
72337419|NCT02305849|144198860|SUPERIORITY||Percent Difference|22.2|||<|0.001|TWO_SIDED|95.0|13.8|30.7||No multiplicity adjustment.|Fisher Exact||C.I. was based on normal approximation to the binomial distribution (continuity corrected).|Treatment Difference vs Placebo||30.7|13.8|<0.001
72337420|NCT02305849|144198860|SUPERIORITY||Percent Difference|38.3|||<|0.001|TWO_SIDED|95.0|29.3|47.3||No multiplicity adjustment.|Fisher Exact||C.I. was based on normal approximation to the binomial distribution (continuity corrected).|Treatment Difference vs Placebo||47.3|29.3|<0.001
72337421|NCT02305849|144198862|SUPERIORITY||Percent Difference|9.7|||<|0.001|TWO_SIDED|95.0|3.8|15.6||No multiplicity adjustment.|Fisher Exact||C.I. was based on normal approximation to the binomial distribution (continuity corrected).|Treatment Difference vs Placebo||15.6|3.8|<0.001
72337422|NCT02305849|144198862|SUPERIORITY||Percent Difference|21.2|||<|0.001|TWO_SIDED|95.0|13.9|28.5||No multiplicity adjustment.|Fisher Exact||C.I. was based on normal approximation to the binomial distribution (continuity corrected).|Treatment Difference vs Placebo||28.5|13.9|<0.001
72337423|NCT02305849|144198864|SUPERIORITY||||||<|0.001||||||Based on RANCOVA Model: Rank of mTSS Change = Treatment + Baseline Rank of mTSS.|RANCOVA|||Treatment Difference vs Placebo||||<0.001
72337424|NCT02305849|144198864|SUPERIORITY||||||<|0.001||||||Based on RANCOVA Model: Rank of mTSS Change = Treatment + Baseline Rank of mTSS.|RANCOVA|||Treatment Difference vs Placebo||||<0.001
72337425|NCT02305849|144198865|SUPERIORITY|||||||0.018|||||||RANCOVA|Based on RANCOVA Model: Rank of JSN Score Change = Treatment + Baseline Rank of JSN score.||Week 28/ET: Treatment Difference vs Placebo||||0.018
72337426|NCT02305849|144198865|SUPERIORITY|||||||0.002|||||||RANCOVA|Based on RANCOVA Model: Rank of JSN Score Change = Treatment + Baseline Rank of JSN score.||Week 28/ET: Treatment Difference vs Placebo||||0.002
72337427|NCT02305849|144198865|SUPERIORITY|||||||0.039|||||||RANCOVA|Based on RANCOVA Model: Rank of JSN Score Change = Treatment + Baseline Rank of JSN Score.||Week 52/ET: Treatment Difference vs Placebo||||0.039
72337428|NCT02305849|144198865|SUPERIORITY|||||||0.006|||||||RANCOVA|Based on RANCOVA Model: Rank of JSN Score Change = Treatment + Baseline Rank of JSN Score.||Week 52/ET: Treatment Difference vs Placebo||||0.006
72337429|NCT02305849|144198866|SUPERIORITY|||||||0.036|||||||RANCOVA|Based on RANCOVA Model: Rank of Erosion Score Change = Treatment + Baseline Rank of Erosion Score.||Week 28/ET: Treatment Difference vs Placebo||||0.036
72337430|NCT02305849|144198866|SUPERIORITY||||||<|0.001|||||||RANCOVA|Based on RANCOVA Model: Rank of Erosion Score Change = Treatment + Baseline Rank of Erosion Score.||Week 28/ET: Treatment Difference vs Placebo||||<0.001
72337431|NCT02305849|144198866|SUPERIORITY|||||||0.013|||||||RANCOVA|Based on RANCOVA Model: Rank of Erosion Score Change = Treatment + Baseline Rank of Erosion Score.||Week 52/ET: Treatment Difference vs Placebo||||0.013
72337432|NCT02305849|144198866|SUPERIORITY||||||<|0.001|||||||RANCOVA|Based on RANCOVA Model: Rank of Erosion Score Change = Treatment + Baseline Rank of Erosion Score.||Week 52/ET: Treatment Difference vs Placebo||||<0.001
72337433|NCT02305849|144198867|SUPERIORITY||Percent Difference|21.3|||<|0.001|TWO_SIDED|95.0|10.0|32.6||No multiplicity adjustment.|Fisher Exact||CI was based on normal approximation to the binomial distribution (continuity corrected).|Week 28/ET: Treatment Difference vs Placebo||32.6|10.0|<0.001
72337434|NCT02305849|144198867|SUPERIORITY||Percent Difference|26.8|||<|0.001|TWO_SIDED|95.0|15.7|37.9||No multiplicity adjustment.|Fisher Exact||CI was based on normal approximation to the binomial distribution (continuity corrected).|Week 28/ET: Treatment Difference vs Placebo||37.9|15.7|<0.001
72337435|NCT02305849|144198867|SUPERIORITY||Percent Difference|21.5|||<|0.001|TWO_SIDED|95.0|10.2|32.9||No multiplicity adjustment.|Fisher Exact||CI was based on normal approximation to the binomial distribution (continuity corrected).|Week 52/ET: Treatment Difference vs Placebo||32.9|10.2|<0.001
72337436|NCT02305849|144198867|SUPERIORITY||Percent Difference|26.4|||<|0.001|TWO_SIDED|95.0|15.2|37.6||No multiplicity adjustment.|Fisher Exact||CI was based on normal approximation to the binomial distribution (continuity corrected).|Week 52/ET: Treatment Difference vs Placebo||37.6|15.2|<0.001
72337437|NCT02305849|144198868|SUPERIORITY||LS Mean difference|-1.21|STANDARD_ERROR_OF_MEAN|0.13|<|0.001|TWO_SIDED|95.0|-1.46|-0.97||No multiplicity adjustment.|ANCOVA|Based on ANCOVA (analysis of covariance) Model: DAS28 Change = Treatment + Baseline DAS28.||Treatment Difference vs Placebo||-0.97|-1.46|<0.001
72337438|NCT02305849|144198868|SUPERIORITY||LS Mean difference|-1.59|STANDARD_ERROR_OF_MEAN|0.13|<|0.001|TWO_SIDED|95.0|-1.85|-1.33||No multiplicity adjustment.|ANCOVA|Based on ANCOVA Model: DAS28 Change = Treatment + Baseline DAS28.||Treatment Difference vs Placebo||-1.33|-1.85|<0.001
72337439|NCT02305849|144198870|SUPERIORITY||LS Mean difference|-1.19|STANDARD_ERROR_OF_MEAN|0.13|<|0.001|TWO_SIDED|95.0|-1.44|-0.94||No multiplicity adjustment.|ANCOVA|Based on ANCOVA Model: DAS28 Change = Treatment + Baseline DAS28.||Treatment Difference vs Placebo||-0.94|-1.44|<0.001
72337440|NCT02305849|144198870|SUPERIORITY||LS Mean difference|-1.63|STANDARD_ERROR_OF_MEAN|0.13|<|0.001|TWO_SIDED|95.0|-1.89|-1.36||No multiplicity adjustment.|ANCOVA|Based on ANCOVA Model: DAS28 Change = Treatment + Baseline DAS28.||Treatment Difference vs Placebo||-1.36|-1.89|<0.001
72337441|NCT02305849|144198872|SUPERIORITY||LS Mean difference|-5.2|STANDARD_ERROR_OF_MEAN|0.9|<|0.001||95.0|-6.9|-3.5||No multiplicity adjustment.|ANCOVA|Based on ANCOVA Model: TJC68 Change = Treatment + Baseline TJC68.||Treatment Difference vs Placebo||-3.5|-6.9|<0.001
72337442|NCT02305849|144198872|SUPERIORITY||LS Mean difference|-7.2|STANDARD_ERROR_OF_MEAN|0.8|<|0.001|TWO_SIDED|95.0|-8.9|-5.6||No multiplicity adjustment.|ANCOVA|Based on ANCOVA Model: TJC68 Change = Treatment + Baseline TJC68.||Treatment Difference vs Placebo||-5.6|-8.9|<0.001
72337443|NCT02305849|144198874|SUPERIORITY||LS Mean difference|-3.9|STANDARD_ERROR_OF_MEAN|0.7|<|0.001|TWO_SIDED|95.0|-5.3|-2.6||No multiplicity adjustment.|ANCOVA|Based on ANCOVA Model: SJC66 Change = Treatment + Baseline SJC66.||Treatment Difference vs Placebo||-2.6|-5.3|<0.001
72337444|NCT02305849|144198874|SUPERIORITY||LS Mean difference|-5.6|STANDARD_ERROR_OF_MEAN|0.6|<|0.001|TWO_SIDED|95.0|-6.9|-4.3||No multiplicity adjustment.|ANCOVA|Based on ANCOVA Model: SJC66 Change = Treatment + Baseline SJC66.||Treatment Difference vs Placebo||-4.3|-6.9|<0.001
72337445|NCT02305849|144198876|SUPERIORITY||Percent Difference|23.7|||<|0.001|TWO_SIDED|95.0|15.1|32.3||No multiplicity adjustment.|Fisher Exact||C.I. was based on normal approximation to the binomial distribution (continuity corrected).|Treatment Difference vs Placebo||32.3|15.1|<0.001
72337446|NCT02305849|144198876|SUPERIORITY||Percent Difference|27.4|||<|0.001|TWO_SIDED|95.0|18.6|36.2||No multiplicity adjustment.|Fisher Exact||C.I. was based on normal approximation to the binomial distribution (continuity corrected).|Treatment Difference vs Placebo||36.2|18.6|<0.001
72337447|NCT02305849|144198878|SUPERIORITY||Percent Difference|10.4|||<|0.001|TWO_SIDED|95.0|4.3|16.5||No multiplicity adjustment.|Fisher Exact||C.I. was based on normal approximation to the binomial distribution (continuity corrected)|Treatment Difference vs Placebo||16.5|4.3|<0.001
72337448|NCT02305849|144198878|SUPERIORITY||Percent Difference|16.9|||<|0.001|TWO_SIDED|95.0|10.0|23.9||No multiplicity adjustment.|Fisher Exact||C.I. was based on normal approximation to the binomial distribution (continuity corrected)|Treatment Difference vs Placebo||23.9|10.0|<0.001
72337449|NCT02305849|144198880|SUPERIORITY||Percent Difference|34.7|||<|0.001|TWO_SIDED|95.0|25.1|44.2||No multiplicity adjustment.|Fisher Exact||C.I. was based on normal approximation to the binomial distribution (continuity corrected).|Treatment Difference vs Placebo||44.2|25.1|<0.001
72337450|NCT02305849|144198880|SUPERIORITY||Percent Difference|45.5|||<|0.001|TWO_SIDED|95.0|36.0|55.0||No multiplicity adjustment.|Fisher Exact||C.I. was based on normal approximation to the binomial distribution (continuity corrected).|Treatment Difference vs Placebo||55.0|36.0|<0.001
72337451|NCT02305849|144198882|SUPERIORITY||Percent Difference|20.3|||<|0.001|TWO_SIDED|95.0|12.5|28.1||No multiplicity adjustment.|Fisher Exact||C.I. was based on normal approximation to the binomial distribution (continuity corrected).|Treatment Difference vs Placebo||28.1|12.5|<0.001
72337452|NCT02305849|144198882|SUPERIORITY||Percent Difference|31.5|||<|0.001|TWO_SIDED|95.0|23.1|40.0||No multiplicity adjustment.|Fisher Exact||C.I. was based on normal approximation to the binomial distribution (continuity corrected).|Treatment Difference vs Placebo||40.0|23.1|<0.001
72369989|NCT02100696|144250372|SUPERIORITY||Difference in Adjusted Means|-4.9||||0.2228|TWO_SIDED|95.0|-12.7|3.0||Nominal P-value reported (not adjusted for multiplicity)|ANCOVA|||||3.0|-12.7|0.2228
72369990|NCT02260180|144250383|SUPERIORITY|2-tail alpha was set to 0.05 with no adjustment for multiple comparisons.|||||<|0.0001|||||||Chi-squared|||||||<0.0001
72369991|NCT02260180|144250383|SUPERIORITY||||||<|0.0001|||||||Chi-squared|2-tail alpha was set to 0.05 with no adjustment for multiple comparisons.||||||<0.0001
72337453|NCT02305849|144198884|SUPERIORITY||LS Mean Difference|-1.597|STANDARD_ERROR_OF_MEAN|0.178|<|0.001|TWO_SIDED|95.0|-1.948|-1.247||No multiplicity adjustment.|ANCOVA|Based on ANCOVA Model: CRP Change = Treatment + Baseline CRP.||Treatment Difference vs Placebo||-1.247|-1.948|<0.001
72337454|NCT02305849|144198884|SUPERIORITY||LS Mean Difference|-1.458|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|-1.852|-1.065||No multiplicity adjustment.|ANCOVA|||Treatment Difference vs Placebo||-1.065|-1.852|<0.001
72337455|NCT02305849|144198886|SUPERIORITY||LS Mean Difference|-17.89|STANDARD_ERROR_OF_MEAN|1.89|<|0.001|TWO_SIDED|95.0|-21.61|-14.17||No multiplicity adjustment.|ANCOVA|Based on ANCOVA Model: ESR Change = Treatment + Baseline ESR.||Treatment Difference vs Placebo||-14.17|-21.61|<0.001
72337456|NCT02305849|144198886|SUPERIORITY||LS Mean Difference|-20.61|STANDARD_ERROR_OF_MEAN|2.06|<|0.001|TWO_SIDED|95.0|-24.67|-16.56||No multiplicity adjustment.|ANCOVA|Based on ANCOVA Model: ESR Change = Treatment + Baseline ESR.||Treatment Difference vs Placebo||-16.56|-24.67|<0.001
72337457|NCT02305849|144198888|SUPERIORITY||Percent Difference|33.0|||<|0.001|TWO_SIDED|95.0|23.7|42.2||No multiplicity adjustment.|Fisher Exact||CI was based on normal approximation to the binomial distribution (continuity corrected).|Treatment Difference vs Placebo||42.2|23.7|<0.001
72337458|NCT02305849|144198888|SUPERIORITY||Percent Difference|45.5|||<|0.001|TWO_SIDED|95.0|36.2|54.8||No multiplicity adjustment.|Fisher Exact||CI was based on normal approximation to the binomial distribution (continuity corrected).|Treatment Difference vs Placebo||54.8|36.2|<0.001
72337459|NCT02305849|144198890|SUPERIORITY||Percent Difference|42.4|||<|0.001|TWO_SIDED|95.0|32.3|52.5||No multiplicity adjustment.|Fisher Exact||CI was based on normal approximation to the binomial distribution (continuity corrected|Treatment Difference vs Placebo||52.5|32.3|<0.001
72337460|NCT02305849|144198890|SUPERIORITY||Percent Difference|49.3|||<|0.001|TWO_SIDED|95.0|39.7|58.9||No multiplicity adjustment.|Fisher Exact||CI was based on normal approximation to the binomial distribution (continuity corrected|Treatment Difference vs Placebo||58.9|39.7|<0.001
72337461|NCT02305849|144198892|SUPERIORITY||Percent Difference|19.7|||<|0.001|TWO_SIDED|95.0|12.1|27.3|||Fisher Exact|No multiplicity adjustment.|CI was based on normal approximation to the binomial distribution (continuity corrected).|Treatment Difference vs Placebo||27.3|12.1|<0.001
72337462|NCT02305849|144198892|SUPERIORITY||Percent Difference|30.4|||<|0.001|TWO_SIDED|95.0|22.0|38.7||No multiplicity adjustment.|Fisher Exact||CI was based on normal approximation to the binomial distribution (continuity corrected).|Treatment Difference vs Placebo||38.7|22.0|<0.001
72337463|NCT02305849|144198894|SUPERIORITY||Percent Difference|42.5|||<|0.001|TWO_SIDED|95.0|32.3|52.6||No multiplicity adjustment.|Fisher Exact||CI was based on normal approximation to the binomial distribution (continuity corrected).|Treatment Difference vs Placebo||52.6|32.3|<0.001
72337464|NCT02305849|144198894|SUPERIORITY||Percent Difference|47.0|||<|0.001|TWO_SIDED|95.0|37.1|56.9||No multiplicity adjustment.|Fisher Exact||CI was based on normal approximation to the binomial distribution (continuity corrected).|Treatment Difference vs Placebo||56.9|37.1|<0.001
72337465|NCT02305849|144198896|SUPERIORITY||Percent Difference|5.2||||0.011|TWO_SIDED|95.0|1.0|9.5||No multiplicity adjustment.|Fisher Exact||CI was based on normal approximation to the binomial distribution (continuity corrected).|Treatment Difference vs Placebo||9.5|1.0|0.011
72337466|NCT02305849|144198896|SUPERIORITY||Percent Difference|9.3|||<|0.001|TWO_SIDED|95.0|4.1|14.6||No multiplicity adjustment.|Fisher Exact||CI was based on normal approximation to the binomial distribution (continuity corrected).|Treatment Difference vs Placebo||14.6|4.1|<0.001
72337467|NCT02305849|144198898|SUPERIORITY|No multiplicity adjustment.|Percent Difference|6.4||||0.003|TWO_SIDED|95.0|1.8|11.0|||Fisher Exact||CI was based on normal approximation to the binomial distribution (continuity corrected).|Treatment Difference vs Placebo||11.0|1.8|0.003
72337468|NCT02305849|144198898|SUPERIORITY||Percent Difference|13.4|||<|0.001|TWO_SIDED|95.0|7.5|19.4||No multiplicity adjustment.|Fisher Exact||CI was based on normal approximation to the binomial distribution (continuity corrected).|Treatment Difference vs Placebo||19.4|7.5|<0.001
72337469|NCT02305849|144198900|SUPERIORITY||LS Mean Difference|-11.22|STANDARD_ERROR_OF_MEAN|1.33|<|0.001|TWO_SIDED|95.0|-13.84|-8.6||No multiplicity adjustment.|ANCOVA|Based on ANCOVA Model: SDAI Change = Treatment + Baseline SDAI.||Treatment Difference vs Placebo||-8.60|-13.84|<0.001
72337470|NCT02305849|144198900|SUPERIORITY||LS Mean Difference|-14.67|STANDARD_ERROR_OF_MEAN|1.36|<|0.001|TWO_SIDED|95.0|-17.35|-11.98||No multiplicity adjustment.|ANCOVA|Based on ANCOVA Model: SDAI Change = Treatment + Baseline SDAI.||Treatment Difference vs Placebo||-11.98|-17.35|<0.001
72337471|NCT02305849|144198902|SUPERIORITY||LS Mean difference|-17.67|STANDARD_ERROR_OF_MEAN|2.26|<|0.001|TWO_SIDED|95.0|-22.11|-13.22||No multiplicity adjustment.|ANCOVA|Based on ANCOVA Model: PGA (100 mm VAS) Change = Treatment + Baseline PGA (100 mm VAS).||Treatment Difference vs Placebo||-13.22|-22.11|<0.001
72337472|NCT02305849|144198902|SUPERIORITY||LS Mean Difference|-24.09|STANDARD_ERROR_OF_MEAN|2.33|<|0.001||95.0|-28.66|-19.51||No multiplicity adjustment.|ANCOVA|Based on ANCOVA Model: PGA (100 mm VAS) Change = Treatment + Baseline PGA (100 mm VAS).||Treatment Difference vs Placebo||-19.51|-28.66|<0.001
72337473|NCT02305849|144198904|SUPERIORITY||LS Mean Difference|-16.64|STANDARD_ERROR_OF_MEAN|2.26|<|0.001|TWO_SIDED|95.0|-21.09|-12.19||No multiplicity adjustment.|ANCOVA|Based on ANCOVA Model: SGA (100 mm VAS) Change = Treatment + Baseline SGA (100 mm VAS)||Treatment Difference vs Placebo||-12.19|-21.09|<0.001
72337474|NCT02305849|144198904|SUPERIORITY||LS Mean difference|-20.34|STANDARD_ERROR_OF_MEAN|2.4|<|0.001|TWO_SIDED|95.0|-25.07|-15.61||No multiplicity adjustment.|ANCOVA|Based on ANCOVA Model: SGA (100 mm VAS) Change = Treatment + Baseline SGA (100 mm VAS).||Treatment Difference vs Placebo||-15.61|-25.07|<0.001
72337475|NCT02305849|144198906|SUPERIORITY||LS Mean Difference|-17.19|STANDARD_ERROR_OF_MEAN|2.44|<|0.001|TWO_SIDED|95.0|-22.0|-12.38||No multiplicity adjustment.|ANCOVA|Based on ANCOVA Model: SGAP (100 mm VAS) Change = Treatment + Baseline SGAP (100 mm VAS).||Treatment Difference vs Placebo||-12.38|-22.00|<0.001
72337476|NCT02305849|144198906|SUPERIORITY||LS Mean difference|-20.89|STANDARD_ERROR_OF_MEAN|2.5|<|0.001|TWO_SIDED|95.0|-25.8|-15.98||No multiplicity adjustment.|ANCOVA|Based on ANCOVA Model: SGAP (100 mm VAS) Change = Treatment + Baseline SGAP (100 mm VAS).||Treatment Difference vs Placebo||-15.98|-25.80|<0.001
72337477|NCT02305849|144198909|SUPERIORITY||LS Mean Difference|-0.27|STANDARD_ERROR_OF_MEAN|0.05|<|0.001|TWO_SIDED|95.0|-0.36|-0.17||No multiplicity adjustment.|ANCOVA|Based on ANCOVA Model: HAQ-DI Change = Treatment + Baseline HAQ-DI.||Treatment Difference vs Placebo||-0.17|-0.36|<0.001
72337478|NCT02305849|144198909|SUPERIORITY||LS Mean Difference|-0.39|STANDARD_ERROR_OF_MEAN|0.05|<|0.001|TWO_SIDED|95.0|-0.48|-0.29||No multiplicity adjustment.|ANCOVA|Based on ANCOVA Model: HAQ-DI Change = Treatment + Baseline HAQ-DI.||Treatment Difference vs Placebo||-0.29|-0.48|<0.001
72337479|NCT02305849|144198911|SUPERIORITY||LS Mean Difference|6.41|STANDARD_ERROR_OF_MEAN|1.18|<|0.001|TWO_SIDED|95.0|4.09|8.74||No multiplicity adjustment.|ANCOVA|Based on ANCOVA Model: SF36-v2 Change = Treatment + Baseline SF36-v2.||Treatment Difference vs Placebo||8.74|4.09|<0.001
72337480|NCT02305849|144198911|SUPERIORITY||LS Mean Difference|8.61|STANDARD_ERROR_OF_MEAN|1.14|<|0.001|TWO_SIDED|95.0|6.36|10.86||No multiplicity adjustment.|ANCOVA|Based on ANCOVA Model: SF36-v2 Change = Treatment + Baseline SF36-v2.||Treatment Difference vs Placebo||10.86|6.36|<0.001
72337481|NCT02305849|144198913|SUPERIORITY||LS Mean Difference|2.7|STANDARD_ERROR_OF_MEAN|0.76|<|0.001|TWO_SIDED|95.0|1.21|4.18||No multiplicity adjustment.|ANCOVA|Based on ANCOVA Model: SF36-v2 Change = Treatment + Baseline SF36-v2.||Treatment Difference vs Placebo||4.18|1.21|<0.001
72337482|NCT02305849|144198913|SUPERIORITY||LS Mean Difference|1.65|STANDARD_ERROR_OF_MEAN|0.78||0.036|TWO_SIDED|95.0|0.11|3.19||No multiplicity adjustment.|ANCOVA|Based on ANCOVA Model: SF36-v2 Change = Treatment + Baseline SF36-v2.||Treatment Difference vs Placebo||3.19|0.11|0.036
72337483|NCT02305849|144198915|SUPERIORITY||LS Mean Difference|2.29|STANDARD_ERROR_OF_MEAN|1.39||0.099|TWO_SIDED|95.0|-0.44|5.02||No multiplicity adjustment.|ANCOVA|Based on ANCOVA Model: SF36-v2 Change = Treatment + Baseline SF36-v2.||Treatment Difference vs Placebo||5.02|-0.44|0.099
72337484|NCT02305849|144198915|SUPERIORITY||LS Mean Difference|4.22|STANDARD_ERROR_OF_MEAN|1.37||0.002|TWO_SIDED|95.0|1.53|6.91||No multiplicity adjustment.|ANCOVA|Based on ANCOVA Model: SF36-v2 Change = Treatment + Baseline SF36-v2.||Treatment Difference vs Placebo||6.91|1.53|0.002
72337485|NCT02305849|144198917|SUPERIORITY||LS Mean Difference|-0.37|STANDARD_ERROR_OF_MEAN|2.43||0.879|TWO_SIDED|95.0|-5.16|4.42||No multiplicity adjustment.|ANCOVA|Based on ANCOVA Model: WPAI Change = Treatment + Baseline WPAI.||Treatment Difference vs Placebo||4.42|-5.16|0.879
72337486|NCT02305849|144198917|SUPERIORITY||LS Mean Difference|-1.81|STANDARD_ERROR_OF_MEAN|2.05||0.377|TWO_SIDED|95.0|-5.86|2.23||No multiplicity adjustment.|ANCOVA|Based on ANCOVA Model: WPAI Change = Treatment + Baseline WPAI.||Treatment Difference vs Placebo||2.23|-5.86|0.377
72337487|NCT02305849|144198919|SUPERIORITY||LS Mean Difference|-9.63|STANDARD_ERROR_OF_MEAN|3.5||0.007|TWO_SIDED|95.0|-16.54|-2.73||No multiplicity adjustment.|ANCOVA|Based on ANCOVA Model: WPAI Change = Treatment + Baseline WPAI.||Treatment Difference vs Placebo||-2.73|-16.54|0.007
72337488|NCT02305849|144198919|SUPERIORITY||LS Mean Difference|-14.17|STANDARD_ERROR_OF_MEAN|3.58|<|0.001|TWO_SIDED|95.0|-21.24|-7.1||No multiplicity adjustment.|ANCOVA|Based on ANCOVA Model: WPAI Change = Treatment + Baseline WPAI.||Treatment Difference vs Placebo||-7.10|-21.24|<0.001
72337489|NCT02305849|144198921|SUPERIORITY||LS Mean Difference|-9.43|STANDARD_ERROR_OF_MEAN|3.63||0.01|TWO_SIDED|95.0|-16.6|-2.25||No multiplicity adjustment.|ANCOVA|Based on ANCOVA Model: WPAI Change = Treatment + Baseline WPAI.||Treatment Difference vs Placebo||-2.25|-16.60|0.010
72337490|NCT02305849|144198921|SUPERIORITY||LS Mean Difference|-14.61|STANDARD_ERROR_OF_MEAN|3.7|<|0.001|TWO_SIDED|95.0|-21.92|-7.31||No multiplicity adjustment.|ANCOVA|Based on ANCOVA Model: WPAI Change = Treatment + Baseline WPAI.||Treatment Difference vs Placebo||-7.31|-21.92|<0.001
72337491|NCT02305849|144198923|SUPERIORITY||LS Mean Difference|-13.19|STANDARD_ERROR_OF_MEAN|2.56|<|0.001|TWO_SIDED|95.0|-18.23|-8.16||No multiplicity adjustment.|ANCOVA|Based on ANCOVA Model: WPAI Change = Treatment + Baseline WPAI.||Treatment Difference vs Placebo||-8.16|-18.23|<0.001
72337492|NCT02305849|144198923|SUPERIORITY||LS Mean Difference|-17.61|STANDARD_ERROR_OF_MEAN|2.52|<|0.001|TWO_SIDED|95.0|-22.57|-12.66||No multiplicity adjustment.|ANCOVA|Based on ANCOVA Model: WPAI Change = Treatment + Baseline WPAI.||Treatment Difference vs Placebo||-12.66|-22.57|<0.001
72337493|NCT02818036|144198955|OTHER|difference in neural activity to social task when taking naltrexone as compared to placebo|||||<|0.01||||||a priori threshold for significance was p\<.05|t-test, 1 sided|degrees of freedom = 75||||||<.01
72337494|NCT02818036|144198956|OTHER|differences in feelings of social connection between those who took naltrexone and those who took placebo||||||0.338||||||a priori threshold for statistical significance was p\<.05|t-test, 2 sided|||||||.338
72337495|NCT01038713|144198957|SUPERIORITY_OR_OTHER|||||||0.22||||||Analysis comparing the number of patients who had stent occlusion|Chi-squared|3 x 2 contingency table comparing all three groups||||||0.22
72337496|NCT01038713|144198957|SUPERIORITY_OR_OTHER|||||||0.14|||||||Chi-squared|3 x 2 contingency table comparing all three groups||Analysis comparing the rate of attempted surgical resection||||0.14
72337497|NCT01038713|144198957|SUPERIORITY_OR_OTHER|||||||0.96|||||||Chi-squared|3 x 2 contingency table comparing all three groups||Analysis comparing the rate of death between groups||||0.96
72337498|NCT01038713|144198958|SUPERIORITY_OR_OTHER|||||||1|||||||ANOVA|||||||1.00
72337499|NCT03777917|144198962|SUPERIORITY||Difference in Response Rates|72.1|||<|0.0001|TWO_SIDED|95.0|47.5|83.5|||Fisher Exact|The Fisher's exact test was used to test for the superiority of treatment (Belotero Balance®) over control.|Two-sided Newcombe confidence interval (CI) for the difference in response rates.|||83.5|47.5|< 0.0001
72337500|NCT00042432|144198972|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.67||||0.006||95.0|1.6|20.06|||Cochran-Mantel-Haenszel|Adjusted for baseline glomenular filtration rate (GFR) strata|Logit estimates|||20.06|1.60|0.006
72337501|NCT00042432|144198973|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANCOVA|Adusted for baseline glomerular filtration rate (GFR) strata||||||<0.001
72337502|NCT01853072|144198974|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.1|STANDARD_ERROR_OF_MEAN|0.4|<|0.001|TWO_SIDED|95.0|1.5|3.0|||Regression, Logistic||Parameter dispersion is the standard error for the odds ratio.|This endpoint was considered primary for United States (US) registration and secondary for European Union (EU) registration.||3.0|1.5|<0.001
72337503|NCT01853072|144198975|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.1|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|0.1|0.3|||Regression, Logistic||Parameter dispersion is the standard error for the odds ratio.|This endpoint was considered primary for EU registration and secondary for US registration.||0.3|0.1|<0.001
72337504|NCT01527383|144198986|OTHER||||||<|0.0001|||||||Longitudinal regression|Visit and stratification factor (biologic or non-biologic autoimmune therapy) were covariates|||The statistical criterion for significance requires that the lower bound of the 2-sided 95% confidence interval of the geometric mean fold rise in vaccine recipients is \>1.0.|||<0.0001
72427854|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.25|STANDARD_ERROR_OF_MEAN|0.134||0.0631|TWO_SIDED|95.0|-0.52|0.01|||MMRM|||Loss of Weight, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.01|-0.52|0.0631
72427855|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.06|STANDARD_ERROR_OF_MEAN|0.131||0.6274|TWO_SIDED|95.0|-0.32|0.2|||MMRM|||Loss of Weight, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.20|-0.32|0.6274
72427856|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.12|STANDARD_ERROR_OF_MEAN|0.128||0.3589|TWO_SIDED|95.0|-0.37|0.14|||MMRM|||Loss of Weight, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.14|-0.37|0.3589
72337505|NCT01527383|144198987|OTHER||||||<|0.0001|||||||Longitudinal regression|Visit and stratification factor (biologic or non-biologic autoimmune therapy) were covariates|||The statistical criterion for significance requires that the lower bound of the 2-sided 95% confidence interval of the geometric mean fold rise in vaccine recipients is \>1.0.|||<0.0001
72337506|NCT01287221|144199030|SUPERIORITY_OR_OTHER|||||||0.82||95.0|||||Wilcoxon (Mann-Whitney)|||Given that there were no imbalances identified between the two groups at baseline and the slope estimates for the two treatment arms did not support assumption of normality, the analysis was performed using Wilcoxon rank-sum test.||||0.82
72337507|NCT01287221|144199031|SUPERIORITY_OR_OTHER|||||||0.62||95.0|||||Wilcoxon (Mann-Whitney)|||Given that there were no imbalances identified between the two groups at baseline and the slope estimates for the two treatment arms did not support assumption of normality, the analysis was performed using Wilcoxon rank-sum test.||||0.62
72337508|NCT01287221|144199032|SUPERIORITY_OR_OTHER|||||||0.23||95.0|||||Wilcoxon (Mann-Whitney)|||Given that there were no imbalances identified between the two groups at baseline and the slope estimates for the two treatment arms did not support assumption of normality, the analysis was performed using Wilcoxon rank-sum test.||||0.23
72337509|NCT01287221|144199033|SUPERIORITY_OR_OTHER|||||||0.31||95.0|||||Wilcoxon (Mann-Whitney)|||Given that there were no imbalances identified between the two groups at baseline and the slope estimates for the two treatment arms did not support assumption of normality, the analysis was performed using Wilcoxon rank-sum test.||||0.31
72337510|NCT01287221|144199034|SUPERIORITY_OR_OTHER|||||||0.65||95.0|||||Wilcoxon (Mann-Whitney)|||Given that there were no imbalances identified between the two groups at baseline and the slope estimates for the two treatment arms did not support assumption of normality, the analysis was performed using Wilcoxon rank-sum test.||||0.65
72337511|NCT01287221|144199035|SUPERIORITY_OR_OTHER|||||||0.61||95.0|||||Wilcoxon (Mann-Whitney)|||Given that there were no imbalances identified between the two groups at baseline and the slope estimates for the two treatment arms did not support assumption of normality, the analysis was performed using Wilcoxon rank-sum test.||||0.61
72337512|NCT01287221|144199036|SUPERIORITY_OR_OTHER|||||||0.22||95.0|||||Wilcoxon (Mann-Whitney)|||Given that there were no imbalances identified between the two groups at baseline and the slope estimates for the two treatment arms did not support assumption of normality, the analysis was performed using Wilcoxon rank-sum test.||||0.22
72337513|NCT00657150|144199037|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority Analysis with NI margin 7.7%|Risk Difference (Percentage)|-1.08|||<|0.0001||95.0|-3.79|1.64||Superiority p-value = 0.4367|Normal approximation|Normal approximation of independent binomial distribution without stratification||Risk difference versus Enoxaparin||1.64|-3.79|< 0.0001
72427857|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.06|STANDARD_ERROR_OF_MEAN|0.187||0.7604|TWO_SIDED|95.0|-0.43|0.31|||MMRM|||Loss of Weight, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.31|-0.43|0.7604
72337514|NCT00657150|144199038|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-1.91||||0.029||95.0|-3.64|-0.19|||Normal approximation|Normal approximation of independent binomial distribution without stratification||||-0.19|-3.64|0.029
72427858|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.185||0.1106|TWO_SIDED|95.0|-0.66|0.07|||MMRM|||Loss of Weight, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.07|-0.66|0.1106
72337515|NCT00657150|144199039|SUPERIORITY_OR_OTHER||Risk Difference (Percentage)|-1.79||||0.0358||95.0|-3.47|-0.12|||Normal approximation|Normal approximation of independent binomial distribution without stratification||Risk difference versus Enoxaparin||-0.12|-3.47|0.0358
72337516|NCT00657150|144199040|SUPERIORITY_OR_OTHER||Risk Difference (Percentage)|-0.96||||0.4839|TWO_SIDED|95.0|-3.65|1.73|||Normal approximation|Normal approximation of independent binomial distribution without stratification||Risk difference versus Enoxaparin||1.73|-3.65|0.4839
72337517|NCT00657150|144199041|SUPERIORITY_OR_OTHER|||||||0.0612||95.0|||||Fisher Exact|||Comparison versus Enoxaparin||||0.0612
72337518|NCT00657150|144199042|SUPERIORITY_OR_OTHER|||||||0.6231||95.0|||||Fisher Exact|||Comparison versus Enoxaparin||||0.6231
72337519|NCT00657150|144199043|SUPERIORITY_OR_OTHER|||||||0.4977||95.0|||||Fisher Exact|||Comparison versus Enoxaparin||||0.4977
72337520|NCT00657150|144199044|SUPERIORITY_OR_OTHER|||||||0.687||95.0|||||Fisher Exact|||Comparison versus Enoxaparin||||0.6870
72337521|NCT00657150|144199045|SUPERIORITY_OR_OTHER|||||||0.4022||95.0|||||Fisher Exact|||Comparison versus Enoxaparin for the category major bleeding events||||0.4022
72337522|NCT00657150|144199045|SUPERIORITY_OR_OTHER||Absolute Difference (Percentage)|0.8||||0.3305|TWO_SIDED|95.0|-0.8|2.3|||Normal approximation|Normal approximation of independent binomial distribution||Absolute difference versus Enoxaparin for the category major and clinically relevant bleeding events||2.3|-0.8|0.3305
72337523|NCT00657150|144199045|SUPERIORITY_OR_OTHER||Absolute Difference (Percentage)|1.4||||0.2626|TWO_SIDED|95.0|-1.1|3.9|||Normal approximation|Normal approximation of independent binomial distribution||Absolute difference versus Enoxaparin for the category any bleeding events||3.9|-1.1|0.2626
72337524|NCT00432744|144199052|SUPERIORITY_OR_OTHER||Kendall's Tau B|0.015|STANDARD_ERROR_OF_MEAN|0.23||0.95|TWO_SIDED|95.0|-0.44|0.48||Two-sided Test|Wilcoxon (Mann-Whitney)||Positive value of Tau-B would favor CoQ.|Study intended to accrue 40 subjects, but only obtained 14 evaluable on this endpoint.||0.48|-0.44|0.95
72337525|NCT00432744|144199053|SUPERIORITY_OR_OTHER||Kendall's Tau B|0.3|STANDARD_ERROR_OF_MEAN|0.21||0.18|TWO_SIDED|95.0|-0.12|0.72|||Wilcoxon (Mann-Whitney)||A positive value would favor CoQ.|Study intended to accrue 40 subjects, but only obtained 14 evaluable on this endpoint.||0.72|-0.12|0.18
72337526|NCT00432744|144199054|SUPERIORITY_OR_OTHER|||||||0.42||||||The Hotelling T-sq=1.74 and 42% of the rerandomizations to groups of 7 and 8 had Hotelling T-sq of at least 1.74. This is the standard method for permutation tests. The large sample null is chi-sq with 2 df, which has a mean=2.|Non-parametric Hotelling T-square|||The actual study was powered to have 40 participants but only 24 participated and of these only 15 had outcome data.||||0.42
72337527|NCT02649192|144199056|SUPERIORITY|||||||0.9|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: No difference between intervention and placebo groups in the ratio of IgA/IgG1 at day 56 in 2015-16 season||||0.90
72337528|NCT02649192|144199056|SUPERIORITY|||||||0.49|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: No difference between intervention and placebo groups in the ratio of IgA/IgG1 at day 56 in 2016-17 season||||0.49
72337529|NCT02649192|144199056|SUPERIORITY|||||||0.5|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: No difference between intervention and placebo groups in the ratio of IgA/IgG1 at day 56 in 2017-18 season||||0.50
72337530|NCT02649192|144199056|SUPERIORITY|||||||0.9|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: No difference between intervention and placebo groups in the ratio of IgA/IgG2 at day 56 in 2015-16 season||||0.90
72337531|NCT02649192|144199056|SUPERIORITY|||||||0.76|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: No difference between intervention and placebo groups in the ratio of IgA/IgG2 at day 56 in 2016-17 season||||0.76
72337532|NCT02649192|144199056|SUPERIORITY|||||||0.65|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: No difference between intervention and placebo groups in the ratio of IgA/IgG2 at day 56 in 2017-18 season||||0.65
72337533|NCT02649192|144199056|SUPERIORITY|||||||0.9|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: No difference between intervention and placebo groups in the ratio of IgA/IgG3 at day 56 in 2015-16 season||||0.90
72337534|NCT02649192|144199056|SUPERIORITY|||||||0.76|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: No difference between intervention and placebo groups in the ratio of IgA/IgG3 at day 56 in 2016-17 season||||0.76
72337535|NCT02649192|144199056|SUPERIORITY|||||||0.54|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: No difference between intervention and placebo groups in the ratio of IgA/IgG3 at day 56 in 2017-18 season||||0.54
72337536|NCT02649192|144199056|SUPERIORITY|||||||0.9|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: No difference between intervention and placebo groups in the ratio of IgA/IgM at day 56 in 2015-16 season||||0.90
72337537|NCT02649192|144199056|SUPERIORITY|||||||0.95|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: No difference between intervention and placebo groups in the ratio of IgA/IgM at day 56 in 2016-17 season||||0.95
72337538|NCT02649192|144199056|SUPERIORITY|||||||0.34|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: No difference between intervention and placebo groups in the ratio of IgA/IgM at day 56 in 2017-18 season||||0.34
72337539|NCT02649192|144199057|SUPERIORITY||Treatment Difference in Seroconversion R|0.0|||||TWO_SIDED|95.0|0.0|0.0|||||Treatment group minus placebo|H1N1||0|0|
72337540|NCT02649192|144199057|SUPERIORITY||Treatment Difference in Seroconversion R|-23.6|||||TWO_SIDED|95.0|-51.7|6.2|||||Treatment group minus placebo|H1N1||6.2|-51.7|
72337541|NCT02649192|144199057|SUPERIORITY||Treatment Difference in Seroconversion R|-13.0|||||TWO_SIDED|95.0|-49.4|26.5|||||Treatment group minus placebo|H1N1||26.5|-49.4|
72337542|NCT02649192|144199057|SUPERIORITY||Treatment Difference in Seroconversion R|-10.0|||||TWO_SIDED|95.0|-70.1|56.1|||||Treatment group minus placebo|H3N2||56.1|-70.1|
72337543|NCT02649192|144199057|SUPERIORITY||Treatment Difference in Seroconversion R|-8.6|||||TWO_SIDED|95.0|-38.8|20.6|||||Treatment group minus placebo|H3N2||20.6|-38.8|
72337544|NCT02649192|144199057|SUPERIORITY||Treatment Difference in Seroconversion R|22.7|||||TWO_SIDED|95.0|-17.5|57.9|||||Treatment group minus placebo|H3N2||57.9|-17.5|
72337545|NCT02649192|144199057|SUPERIORITY||Treatment Difference in Seroconversion R|0.0|||||TWO_SIDED|95.0|0.0|0.0|||||Treatment group minus placebo|B/Phuket||0|0|
72337546|NCT02649192|144199057|SUPERIORITY||Treatment Difference in Seroconversion R|-26.4|||||TWO_SIDED|95.0|-54.1|5.8|||||Treatment group minus placebo|B/Phuket||5.8|-54.1|
72337547|NCT02649192|144199057|SUPERIORITY||Treatment Difference in Seroconversion R|16.9|||||TWO_SIDED|95.0|-23.1|53.3|||||Treatment group minus placebo|B/Phuket||53.3|-23.1|
72337548|NCT02649192|144199057|SUPERIORITY||Treatment Difference in Seroconversion R|0.0|||||TWO_SIDED|95.0|0.0|0.0|||||Treatment group minus placebo|B/Brisbane||0|0|
72337549|NCT02649192|144199057|SUPERIORITY||Treatment Difference in Seroconversion R|-26.4|||||TWO_SIDED|95.0|-54.1|5.8|||||Treatment group minus placebo|B/Brisbane||5.8|-54.1|
72337550|NCT02649192|144199057|SUPERIORITY||Treatment Difference in Seroconversion R|-8.4|||||TWO_SIDED|95.0|-45.4|30.5|||||Treatment group minus placebo|B/Brisbane||30.5|-45.4|
72337551|NCT03849690|144199061|OTHER|Analysis of variance (ANOVA) performed on natural log(ln)-transformed TAK-906 Cmax which exponentiated to provide estimates on original scale. ANOVA model included treatment as fixed effect and participant as random effect. Each ANOVA included calculation of least-squares means(LSM) and difference between treatment LSM. Geometric mean ratios and 90% confidence interval (CI) were determined by exponentiation of appropriate estimates for difference between treatments in log-transformed parameters.|Geometric mean ratio|0.87||||0.3011|TWO_SIDED|90.0|0.7|1.09|||ANOVA|||||1.09|0.70|0.3011
72337552|NCT03849690|144199062|OTHER|ANOVA was performed on ln-transformed TAK-906 AUClast which were exponentiated to provide estimates on original scale. ANOVA model included treatment as fixed effect and participant as a random effect. Each ANOVA included calculation of LSM and difference between treatment LSM. Geometric mean ratios and 90 percent (%) CI were determined by exponentiation of appropriate estimates for difference between treatments in log-transformed parameters.|Geometric mean ratio|0.88||||0.0865|TWO_SIDED|90.0|0.77|0.99|||ANOVA|||||0.99|0.77|0.0865
72337553|NCT03849690|144199063|OTHER|ANOVA was performed on ln-transformed TAK-906 AUC∞ which were exponentiated to provide estimates on original scale. ANOVA model included treatment as fixed effect and participant as a random effect. Each ANOVA included calculation of LSM and difference between treatment LSM. Geometric mean ratios and 90% CI were determined by exponentiation of appropriate estimates for difference between treatments in log-transformed parameters.|Geometric mean ratio|0.88||||0.3011|TWO_SIDED|90.0|0.78|1.0|||ANOVA|||||1.00|0.78|0.3011
72337554|NCT00438854|144199074|SUPERIORITY_OR_OTHER||Estimating proportion of responders|0.2||||||||||||||The primary measures of efficacy of tumor response were: complete remission (CR), nodular partial remission (nPR), or partial remission (PR), as per NCI-WG criteria. The true ORR is reported as percentage and 90% CI calculated using the binomial exact test. Time to treatment failure (TTF) was defined from the date on study to date of progression, death in remission, initiation of non-protocol therapy in the absence of progression, or censored on the last visit.||||
72337555|NCT00468845|144199079|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1378||95.0||||Weighted Z-score test method of Fisher (1998) and Cui et al (1999)applied to maintain alpha level. A step down procedure for multiple comparisons to control the maximum experiment wise type I error rate at 0.05 level. 300mg tested prior to 150mg.|ANOVA|||||||0.1378
72337556|NCT00468845|144199079|SUPERIORITY_OR_OTHER_LEGACY|||||||0.471||95.0||||Weighted Z-score test method of Fisher (1998) and Cui et al (1999)applied to maintain alpha level. A step down procedure for multiple comparisons to control the maximum experiment wise type I error rate at 0.05 level. 300mg tested prior to 150mg.|ANOVA|||||||0.4710
72337557|NCT00468845|144199080|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7752||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||24 hours PS||||0.7752
72337558|NCT00468845|144199080|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3375||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||24 hours PS||||0.3375
72337559|NCT00468845|144199080|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7029||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||48 hours PS||||0.7029
72337560|NCT00468845|144199080|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8618||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||48 hours PS||||0.8618
72337561|NCT00468845|144199080|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2117||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||72 hours PS||||0.2117
72337562|NCT00468845|144199080|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6255||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||72 hours PS||||0.6255
72337563|NCT00468845|144199080|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0942||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||96 hours PS||||0.0942
72337564|NCT00468845|144199080|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9907||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||96 hours PS||||0.9907
72337565|NCT00468845|144199080|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4678||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||120 hours PS||||0.4678
72337566|NCT00468845|144199080|SUPERIORITY_OR_OTHER_LEGACY|||||||0.55||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||120 hours PS||||0.5500
72337567|NCT00468845|144199080|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9333||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||144 hours PS||||0.9333
72337568|NCT00468845|144199080|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7396||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||144 hours PS||||0.7396
72337569|NCT00468845|144199080|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2932||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Discharge||||0.2932
72337570|NCT00468845|144199080|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0164||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Discharge||||0.0164
72337571|NCT00468845|144199080|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2468||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 14||||0.2468
72337572|NCT00468845|144199080|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7022||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 14||||0.7022
72337573|NCT00468845|144199080|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7257||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 28||||0.7257
72337574|NCT00468845|144199080|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3854||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 28||||0.3854
72337575|NCT00468845|144199081|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5997||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||24 hours PS||||0.5997
72337576|NCT00468845|144199081|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8582||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||24 hours PS||||0.8582
72337577|NCT00468845|144199081|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3704||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||48 hours PS||||0.3704
72337578|NCT00468845|144199081|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9747||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||48 hours PS||||0.9747
72337579|NCT00468845|144199081|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2033||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||72 hours PS||||0.2033
72337580|NCT00468845|144199081|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2752||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||72 hours PS||||0.2752
72337581|NCT00468845|144199081|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0183||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||96 hours PS||||0.0183
72337582|NCT00468845|144199081|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6906||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||96 hours PS||||0.6906
72337583|NCT00468845|144199081|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5446||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||120 hours PS||||0.5446
72337584|NCT00468845|144199081|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4852||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||120 hours PS||||0.4852
72337585|NCT00468845|144199081|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5879||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||144 hours PS||||0.5879
72337586|NCT00468845|144199081|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7699||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||144 hours PS||||0.7699
72337587|NCT00468845|144199082|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9676||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||||||0.9676
72337588|NCT00468845|144199082|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4944||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||||||0.4944
72337589|NCT00468845|144199083|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4801||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||||||0.4801
72337590|NCT00468845|144199083|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8832||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||||||0.8832
72337591|NCT00468845|144199084|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2125||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||8 Hours PS||||0.2125
72337592|NCT00468845|144199084|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7602||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||8 Hour PS||||0.7602
72337593|NCT00468845|144199084|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4053||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||16 Hours PS||||0.4053
72337594|NCT00468845|144199084|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4147||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||16 Hours PS||||0.4147
72337595|NCT00468845|144199084|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5556||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||24 Hours PS||||0.5556
72337596|NCT00468845|144199084|SUPERIORITY_OR_OTHER_LEGACY|||||||0.482||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||24 Hours PS||||0.4820
72337597|NCT00468845|144199084|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5088||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||32 Hours PS||||0.5088
72337598|NCT00468845|144199084|SUPERIORITY_OR_OTHER_LEGACY|||||||0.39||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||32 Hours PS||||0.3900
72337599|NCT00468845|144199084|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9659||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||40 Hours PS||||0.9659
72337600|NCT00468845|144199084|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3968||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||40 Hours PS||||0.3968
72337601|NCT00468845|144199084|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8308||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||48 Hours PS||||0.8308
72337602|NCT00468845|144199084|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0902||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||48 Hours PS||||0.0902
72337603|NCT00468845|144199085|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4388||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||||||0.4388
72337604|NCT00468845|144199085|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3364||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||||||0.3364
72337605|NCT00468845|144199086|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2409||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||24 hours PS||||0.2409
72337606|NCT00468845|144199086|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1654||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||24 hours PS||||0.1654
72337607|NCT00468845|144199086|SUPERIORITY_OR_OTHER_LEGACY|||||||0.111||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||48 hours PS||||0.1110
72337608|NCT00468845|144199086|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0598||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||48 hours PS||||0.0598
72337609|NCT00468845|144199086|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0398||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Till Discharge||||0.0398
72337610|NCT00468845|144199086|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0623||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Till Discharge||||0.0623
72337611|NCT00468845|144199087|SUPERIORITY_OR_OTHER_LEGACY|||||||0.273||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||0-24 Hours PS||||0.2730
72337612|NCT00468845|144199087|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1015||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||0-24 Hours PS||||0.1015
72337613|NCT00468845|144199087|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2438||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||24-48 Hours PS||||0.2438
72337614|NCT00468845|144199087|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0102||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||24-48 Hours PS||||0.0102
72337615|NCT00468845|144199087|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2063||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||48-72 Hours PS||||0.2063
72337616|NCT00468845|144199087|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0387||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||48-72 Hours PS||||0.0387
72337617|NCT00468845|144199088|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5995||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||24 hours PS||||0.5995
72337618|NCT00468845|144199088|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9104||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||24 Hours PS||||0.9104
72337619|NCT00468845|144199088|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2177||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||48 Hours PS||||0.2177
72337620|NCT00468845|144199088|SUPERIORITY_OR_OTHER_LEGACY|||||||0.177||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||48 hours PS||||0.1770
72337621|NCT00468845|144199088|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1229||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||72 hours PS||||0.1229
72337622|NCT00468845|144199088|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1274||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||72 hours PS||||0.1274
72337623|NCT00468845|144199088|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0568||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||1st Week PS||||0.0568
72337624|NCT00468845|144199088|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0354||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||1st Week PS||||0.0354
72337625|NCT00468845|144199088|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4269||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||2nd Week PS||||0.4269
72337626|NCT00468845|144199088|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2058||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||2nd Week PS||||0.2058
72337627|NCT00468845|144199088|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8215||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||3rd Week PS||||0.8215
72337628|NCT00468845|144199088|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5331||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||3rd Week PS||||0.5331
72337629|NCT00468845|144199088|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7365||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||4th Week PS||||0.7365
72337630|NCT00468845|144199088|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9989||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||4th Week PS||||0.9989
72337631|NCT00468845|144199088|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2501||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Till Discharge||||0.2501
72337632|NCT00468845|144199088|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6021||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Till Discharge||||0.6021
72337633|NCT00468845|144199089|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6613||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Surgery day (prior to first dose)||||0.6613
72337634|NCT00468845|144199089|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1311||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Surgery day (prior to first dose)||||0.1311
72337635|NCT00468845|144199089|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6574||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Surgery day (1 hour after dosing)||||0.6574
72337636|NCT00468845|144199089|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6949||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Surgery day (1 hour after dosing)||||0.6949
72337637|NCT00468845|144199089|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2008||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 1 PS||||0.2008
72337638|NCT00468845|144199089|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3022||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 1 PS||||0.3022
72337639|NCT00468845|144199089|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6382||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 2 PS||||0.6382
72337640|NCT00468845|144199089|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8624||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 2 PS||||0.8624
72337641|NCT00468845|144199089|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3858||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 3 PS||||0.3858
72337642|NCT00468845|144199089|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4814||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 3 PS||||0.4814
72337643|NCT00468845|144199089|SUPERIORITY_OR_OTHER_LEGACY|||||||0.952||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 4 PS||||0.9520
72337644|NCT00468845|144199089|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2315||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 4 PS||||0.2315
72337645|NCT00468845|144199089|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7061||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 5 PS||||0.7061
72427859|NCT02942004|144367030|SUPERIORITY||LS mean difference|0.01|STANDARD_ERROR_OF_MEAN|0.222||0.9776|TWO_SIDED|95.0|-0.43|0.45|||MMRM|||Loss of Weight, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.45|-0.43|0.9776
72337646|NCT00468845|144199089|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2908||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 5 PS||||0.2908
72337647|NCT00468845|144199089|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4782||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Discharge||||0.4782
72337648|NCT00468845|144199089|SUPERIORITY_OR_OTHER_LEGACY|||||||0.813||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Discharge||||0.8130
72337649|NCT00468845|144199090|SUPERIORITY_OR_OTHER_LEGACY|||||||0.894||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||24 hours PS||||0.8940
72337650|NCT00468845|144199090|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5938||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||24 hours PS||||0.5938
72337651|NCT00468845|144199090|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4306||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||48 hours PS||||0.4306
72337652|NCT00468845|144199090|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5899||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||48 hours PS||||0.5899
72337653|NCT00468845|144199090|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2209||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||72 hours PS||||0.2209
72337654|NCT00468845|144199090|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7145||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||72 hours PS||||0.7145
72337655|NCT00468845|144199090|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1022||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||1st Week PS||||0.1022
72337656|NCT00468845|144199090|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7243||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||1st Week PS||||0.7243
72337657|NCT00468845|144199090|SUPERIORITY_OR_OTHER_LEGACY|||||||0.231||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||2nd Week PS||||0.2310
72337658|NCT00468845|144199090|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9192||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||2nd Week PS||||0.9192
72337659|NCT00468845|144199090|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3214||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||3rd Week PS||||0.3214
72337660|NCT00468845|144199090|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8641||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||3rd Week PS||||0.8641
72337661|NCT00468845|144199090|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3024||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||4th Week PS||||0.3024
72337662|NCT00468845|144199090|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7359||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||4th Week PS||||0.7359
72337663|NCT00468845|144199090|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4303||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Till Discharge||||0.4303
72337664|NCT00468845|144199090|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2133||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Till Discharge||||0.2133
72337665|NCT00468845|144199091|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5682||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||8 hours PS||||0.5682
72337666|NCT00468845|144199091|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1005||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||8 hours PS||||0.1005
72337667|NCT00468845|144199091|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8261||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||16 hours PS||||0.8261
72337668|NCT00468845|144199091|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9981||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||16 hours PS||||0.9981
72337669|NCT00468845|144199091|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8884||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||24 hours PS||||0.8884
72337670|NCT00468845|144199091|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4507||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||24 hours PS||||0.4507
72337671|NCT00468845|144199091|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2994||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||32 hours PS||||0.2994
72337672|NCT00468845|144199091|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4371||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||32 hours PS||||0.4371
72337673|NCT00468845|144199091|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8295||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||40 hours PS||||0.8295
72337674|NCT00468845|144199091|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8783||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||40 hours PS||||0.8783
72337675|NCT00468845|144199091|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2161||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||48 hours PS||||0.2161
72337676|NCT00468845|144199091|SUPERIORITY_OR_OTHER_LEGACY|||||||0.044||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||48 hours PS||||0.0440
72337677|NCT00468845|144199091|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3855||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||56 hours PS||||0.3855
72337678|NCT00468845|144199091|SUPERIORITY_OR_OTHER_LEGACY|||||||0.201||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||56 hours PS||||0.2010
72337679|NCT00468845|144199091|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7104||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||64 hours PS||||0.7104
72337680|NCT00468845|144199091|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6107||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||64 hours PS||||0.6107
72337681|NCT00468845|144199091|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6705||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||72 hours PS||||0.6705
72337682|NCT00468845|144199091|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2083||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||72 hours PS||||0.2083
72337683|NCT00468845|144199091|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3234||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||80 hours PS||||0.3234
72337684|NCT00468845|144199091|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5938||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||80 hours PS||||0.5938
72337685|NCT00468845|144199091|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9711||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||88 hours PS||||0.9711
72337686|NCT00468845|144199091|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4869||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||88 hours PS||||0.4869
72337687|NCT00468845|144199091|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7439||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||96 hours PS||||0.7439
72337688|NCT00468845|144199091|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8045||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||96 hours PS||||0.8045
72337689|NCT00468845|144199091|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5925||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||104 hours PS||||0.5925
72337690|NCT00468845|144199091|SUPERIORITY_OR_OTHER_LEGACY|||||||0.683||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||104 hours PS||||0.6830
72337691|NCT00468845|144199091|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8266||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||112 hours PS||||0.8266
72337692|NCT00468845|144199091|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1929||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||112 hours PS||||0.1929
72337693|NCT00468845|144199091|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7071||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||120 hours PS||||0.7071
72337694|NCT00468845|144199091|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9367||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||120 hours PS||||0.9367
72337695|NCT00468845|144199091|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6046||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||128 hours PS||||0.6046
72337696|NCT00468845|144199091|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5119||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||128 hours PS||||0.5119
72337697|NCT00468845|144199092|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6966||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 1 PS||||0.6966
72337698|NCT00468845|144199092|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1808||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 1 PS||||0.1808
72337699|NCT00468845|144199092|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2616||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 2 PS||||0.2616
72337700|NCT00468845|144199092|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1014||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 2 PS||||0.1014
72337701|NCT00468845|144199092|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4401||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 3 PS||||0.4401
72337702|NCT00468845|144199092|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5615||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 3 PS||||0.5615
72337703|NCT00468845|144199092|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7615||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 4 PS||||0.7615
72337704|NCT00468845|144199092|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6204||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 4 PS||||0.6204
72337705|NCT00468845|144199092|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8766||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 5 PS||||0.8766
72337706|NCT00468845|144199092|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1717||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 5 PS||||0.1717
72337707|NCT00468845|144199092|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4065||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Discharge||||0.4065
72337708|NCT00468845|144199092|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0746||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Discharge||||0.0746
72337709|NCT00468845|144199093|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2201||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 2 PS||||0.2201
72337710|NCT00468845|144199093|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0606||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 2 PS||||0.0606
72337711|NCT00468845|144199093|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5303||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 3 PS||||0.5303
72337712|NCT00468845|144199093|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2227||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 3 PS||||0.2227
72337713|NCT00468845|144199093|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8237||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 4 PS||||0.8237
72337714|NCT00468845|144199093|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7476||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 4 PS||||0.7476
72337715|NCT00468845|144199093|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6882||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 5 PS||||0.6882
72337716|NCT00468845|144199093|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9689||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 5 PS||||0.9689
72337717|NCT00468845|144199093|SUPERIORITY_OR_OTHER_LEGACY|||||||0.501||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 6 PS||||0.5010
72337718|NCT00468845|144199093|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9143||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 6 PS||||0.9143
72337719|NCT00468845|144199093|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7381||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 7 PS||||0.7381
72337720|NCT00468845|144199093|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5336||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 7 PS||||0.5336
72337721|NCT00468845|144199093|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6479||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||2nd Week PS (Average)||||0.6479
72337722|NCT00468845|144199093|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1133||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||2nd Week PS (Average)||||0.1133
72337723|NCT00468845|144199093|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7637||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||3rd Week PS (Average)||||0.7637
72337724|NCT00468845|144199093|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1056||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||3rd Week PS (Average)||||0.1056
72337725|NCT00468845|144199093|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8079||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||4th Week PS (Average)||||0.8079
72337726|NCT00468845|144199093|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0917||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||4th Week PS (Average)||||0.0917
72337727|NCT00468845|144199094|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7511||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Discharge||||0.7511
72337728|NCT00468845|144199094|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6742||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Discharge||||0.6742
72337729|NCT00468845|144199094|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3808||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 7||||0.3808
72337730|NCT00468845|144199094|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7021||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 7||||0.7021
72337731|NCT00468845|144199094|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0045||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 14||||0.0045
72337732|NCT00468845|144199094|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7916||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 14||||0.7916
72337733|NCT00468845|144199094|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3682||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 28||||0.3682
72337734|NCT00468845|144199094|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1419||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 28||||0.1419
72337735|NCT00468845|144199095|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3323||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 2 PS||||0.3323
72337736|NCT00468845|144199095|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5662||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 2 PS||||0.5662
72337737|NCT00468845|144199095|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9538||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 3 PS||||0.9538
72337738|NCT00468845|144199095|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4592||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 3 PS||||0.4592
72337739|NCT00468845|144199095|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4793||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 4 PS||||0.4793
72337740|NCT00468845|144199095|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8517||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 4 PS||||0.8517
72337741|NCT00468845|144199095|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1829||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 5 PS||||0.1829
72337742|NCT00468845|144199095|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3544||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 5 PS||||0.3544
72427860|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.21|STANDARD_ERROR_OF_MEAN|0.217||0.3239|TWO_SIDED|95.0|-0.65|0.22|||MMRM|||Loss of Weight, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.22|-0.65|0.3239
72427861|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.238||0.6736|TWO_SIDED|95.0|-0.57|0.37|||MMRM|||Loss of Weight, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.37|-0.57|0.6736
72427862|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.12|STANDARD_ERROR_OF_MEAN|0.231||0.6136|TWO_SIDED|95.0|-0.58|0.34|||MMRM|||Loss of Weight, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.34|-0.58|0.6136
72427863|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.31|STANDARD_ERROR_OF_MEAN|0.195||0.1141|TWO_SIDED|95.0|-0.7|0.08|||MMRM|||Loss of Weight, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.08|-0.70|0.1141
72427864|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.24|STANDARD_ERROR_OF_MEAN|0.194||0.2185|TWO_SIDED|95.0|-0.62|0.14|||MMRM|||Loss of Weight, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.14|-0.62|0.2185
72427865|NCT02942004|144367030|SUPERIORITY||LS mean difference|0.03|STANDARD_ERROR_OF_MEAN|0.054||0.6191|TWO_SIDED|95.0|-0.08|0.13|||MMRM|||Insight, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.13|-0.08|0.6191
72337743|NCT00468845|144199095|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1718||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 6 PS||||0.1718
72337744|NCT00468845|144199095|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5078||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 6 PS||||0.5078
72427866|NCT02942004|144367030|SUPERIORITY||LS mean difference|0.03|STANDARD_ERROR_OF_MEAN|0.053||0.6169|TWO_SIDED|95.0|-0.08|0.13|||MMRM|||Insight, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.13|-0.08|0.6169
72427867|NCT02942004|144367030|SUPERIORITY||LS mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.054||0.9911|TWO_SIDED|95.0|-0.11|0.11|||MMRM|||Insight, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.11|-0.11|0.9911
72337745|NCT00468845|144199095|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2443||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 7 PS||||0.2443
72427868|NCT02942004|144367030|SUPERIORITY||LS mean difference|0.05|STANDARD_ERROR_OF_MEAN|0.053||0.336|TWO_SIDED|95.0|-0.05|0.15|||MMRM|||Insight, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.15|-0.05|0.3360
72337746|NCT00468845|144199095|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8296||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 7 PS||||0.8296
72337747|NCT00468845|144199095|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3243||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||2nd Week PS (Average)||||0.3243
72337748|NCT00468845|144199095|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3755||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||2nd Week PS (Average)||||0.3755
72337749|NCT00468845|144199095|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9584||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||3rd Week PS (Average)||||0.9584
72337750|NCT00468845|144199095|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1187||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||3rd Week PS (Average)||||0.1187
72337751|NCT00468845|144199095|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7915||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||4th Week PS (Average)||||0.7915
72337752|NCT00468845|144199095|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0703||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||4th Week PS (Average)||||0.0703
72337753|NCT00468845|144199096|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1975||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Discharge;||||0.1975
72337754|NCT00468845|144199096|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2784||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Discharge;||||0.2784
72337755|NCT00468845|144199096|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0271||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 7||||0.0271
72337756|NCT00468845|144199096|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0881||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 7||||0.0881
72337757|NCT00468845|144199096|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0159||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 14||||0.0159
72337758|NCT00468845|144199096|SUPERIORITY_OR_OTHER_LEGACY|||||||0.187||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 14||||0.1870
72337759|NCT00468845|144199096|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1752||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 28||||0.1752
72337760|NCT00468845|144199096|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6923||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 28||||0.6923
72337761|NCT00468845|144199099|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6295||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Discharge||||0.6295
72337762|NCT00468845|144199099|SUPERIORITY_OR_OTHER_LEGACY|||||||0.689||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Discharge||||0.6890
72337763|NCT00468845|144199099|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5094||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 7||||0.5094
72337764|NCT00468845|144199099|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8741||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 7||||0.8741
72337765|NCT00468845|144199099|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0214||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 14||||0.0214
72337766|NCT00468845|144199099|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9366||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 14||||0.9366
72337767|NCT00468845|144199099|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7833||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 28||||0.7833
72337768|NCT00468845|144199099|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2983||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 28||||0.2983
72337769|NCT00468845|144199102|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6861||95.0|||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted for pooled centers and salpingo-oophorectomy strata.||Surgery Day||||0.6861
72337770|NCT00468845|144199102|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9905||95.0|||||Cochran-Mantel-Haenszel|CMH test adjusted for pooled centers and salpingo-oophorectomy strata.||Surgery Day||||0.9905
72337771|NCT00468845|144199103|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4264||95.0|||||Cochran-Mantel-Haenszel|CMH test adjusted for pooled centers and salpingo-oophorectomy strata.||Day 1 PS||||0.4264
72337772|NCT00468845|144199103|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3045||95.0|||||Cochran-Mantel-Haenszel|CMH test adjusted for pooled centers and salpingo-oophorectomy strata.||Day 1 PS||||0.3045
72337773|NCT00468845|144199104|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0714||95.0|||||Cochran-Mantel-Haenszel|CMH test adjusted for pooled centers and salpingo-oophorectomy strata.||Day 2 PS||||0.0714
72337774|NCT00468845|144199104|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4455||95.0|||||Cochran-Mantel-Haenszel|CMH test adjusted for pooled centers and salpingo-oophorectomy strata.||Day 2 PS||||0.4455
72337775|NCT00468845|144199105|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7418||95.0|||||Cochran-Mantel-Haenszel|CMH test adjusted for pooled centers and salpingo-oophorectomy strata.||Day 3 PS||||0.7418
72337776|NCT00468845|144199105|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5154||95.0|||||Cochran-Mantel-Haenszel|CMH test adjusted for pooled centers and salpingo-oophorectomy strata.||Day 3 PS||||0.5154
72337777|NCT00468845|144199106|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6715||95.0|||||Cochran-Mantel-Haenszel|CMH test adjusted for pooled centers and salpingo-oophorectomy strata.||Day 4 PS||||0.6715
72337778|NCT00468845|144199106|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9013||95.0|||||Cochran-Mantel-Haenszel|CMH test adjusted for pooled centers and salpingo-oophorectomy strata.||Day 4 PS||||0.9013
72337779|NCT00468845|144199107|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9126||95.0|||||Cochran-Mantel-Haenszel|CMH test adjusted for pooled centers and salpingo-oophorectomy strata.||Day 5 PS||||0.9126
72337780|NCT00468845|144199107|SUPERIORITY_OR_OTHER_LEGACY|||||||1||95.0|||||Cochran-Mantel-Haenszel|CMH test adjusted for pooled centers and salpingo-oophorectomy strata.||Day 5 PS||||1.0000
72337781|NCT00468845|144199108|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1233||95.0|||||Cochran-Mantel-Haenszel|CMH test adjusted for pooled centers and salpingo-oophorectomy strata.||Discharge||||0.1233
72337782|NCT00468845|144199108|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1666||95.0|||||Cochran-Mantel-Haenszel|CMH test adjusted for pooled centers and salpingo-oophorectomy strata.||Discharge||||0.1666
72337783|NCT00468845|144199109|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0361||95.0|||||Cochran-Mantel-Haenszel|CMH test adjusted for pooled centers and salpingo-oophorectomy strata.||Day 7||||0.0361
72337784|NCT00468845|144199109|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0797||95.0|||||Cochran-Mantel-Haenszel|CMH test adjusted for pooled centers and salpingo-oophorectomy strata.||Day 7||||0.0797
72337785|NCT00468845|144199110|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0206||95.0|||||Cochran-Mantel-Haenszel|CMH test adjusted for pooled centers and salpingo-oophorectomy strata.||Day 14||||0.0206
72337786|NCT00468845|144199110|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0011||95.0|||||Cochran-Mantel-Haenszel|CMH test adjusted for pooled centers and salpingo-oophorectomy strata.||Day 14||||0.0011
72337787|NCT00468845|144199112|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3506||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||24 hours||||0.3506
72337788|NCT00468845|144199113|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0287||95.0|||||Cochran-Mantel-Haenszel|CMH test adjusted for pooled centers and salpingo-oophorectomy strata.||Day 28||||0.0287
72337789|NCT00468845|144199113|SUPERIORITY_OR_OTHER_LEGACY|||||||0.227||95.0|||||Cochran-Mantel-Haenszel|CMH test adjusted for pooled centers and salpingo-oophorectomy strata.||Day 28||||0.2270
72337790|NCT00468845|144199114|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1872||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Medication Subscale at Discharge||||0.1872
72337791|NCT00468845|144199114|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3994||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Medication Subscale at Discharge||||0.3994
72337792|NCT00468845|144199114|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0422||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Medication Subscale at Day 28||||0.0422
72337793|NCT00468845|144199114|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3647||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Medication Subscale at Day 28||||0.3647
72337794|NCT00468845|144199114|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1729||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Characteristics at Discharge||||0.1729
72337795|NCT00468845|144199114|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2234||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Characteristics at Discharge||||0.2234
72337796|NCT00468845|144199114|SUPERIORITY_OR_OTHER_LEGACY|||||||0.095||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Characteristics at Day 28||||0.0950
72427869|NCT02942004|144367030|SUPERIORITY||LS mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.054||0.9638|TWO_SIDED|95.0|-0.11|0.1|||MMRM|||Insight, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.10|-0.11|0.9638
72337797|NCT00468845|144199114|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4345||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Characteristics at Day 28||||0.4345
72337798|NCT00468845|144199114|SUPERIORITY_OR_OTHER_LEGACY|||||||0.284||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Efficacy at Discharge||||0.2840
72337799|NCT00468845|144199114|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6404||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Efficacy at Discharge||||0.6404
72337800|NCT00468845|144199114|SUPERIORITY_OR_OTHER_LEGACY|||||||0.055||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Efficacy at Day 28||||0.0550
72337801|NCT00468845|144199114|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4531||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Efficacy at Day 28||||0.4531
72337802|NCT00468845|144199115|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9712||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Discharge||||0.9712
72337803|NCT00468845|144199115|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0112||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Discharge||||0.0112
72337804|NCT00468845|144199115|SUPERIORITY_OR_OTHER_LEGACY|||||||0.009||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 28||||0.0090
72337805|NCT00468845|144199115|SUPERIORITY_OR_OTHER_LEGACY|||||||0.865||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 28||||0.8650
72337806|NCT00468845|144199116|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8914||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||EQ-5D 1997 Discharge||||0.8914
72337807|NCT00468845|144199116|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2214||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||EQ-5D 1997 Discharge||||0.2214
72337808|NCT00468845|144199116|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1008||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||EQ-5D 1997 Day 28||||0.1008
72337809|NCT00468845|144199116|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9135||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||EQ-5D 1997 Day 28||||0.9135
72337810|NCT00468845|144199116|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5609||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||EQ-5D 2001 Discharge||||0.5609
72337811|NCT00468845|144199116|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4047||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||EQ-5D 2001 Discharge||||0.4047
72337812|NCT00468845|144199116|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1663||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||EQ-5D 2001 Day 28||||0.1663
72337813|NCT00468845|144199116|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8364||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||EQ-5D 2001 Day 28||||0.8364
72337814|NCT00468845|144199117|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7218||95.0|||||Log Rank|||Kaplan-Meier method was used for survival distribution estimation;||||0.7218
72337815|NCT00468845|144199117|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4425||95.0|||||Log Rank|||Kaplan-Meier method was used for survival distribution estimation;||||0.4425
72337816|NCT00468845|144199118|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7889||95.0|||||Log Rank|||Kaplan-Meier method was used for survival distribution estimation;||||0.7889
72337817|NCT00468845|144199118|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1565||95.0|||||Log Rank|||Kaplan-Meier method was used for survival distribution estimation;||||0.1565
72337818|NCT00468845|144199119|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6211||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Total subscale||||0.6211
72337819|NCT00468845|144199119|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3687||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Total subscale||||0.3687
72337820|NCT00468845|144199119|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7078||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Burning Spontaneous subscale||||0.7078
72337821|NCT00468845|144199119|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8696||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Burning Spontaneous subscale||||0.8696
72337822|NCT00468845|144199119|SUPERIORITY_OR_OTHER_LEGACY|||||||0.432||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Pressing Spontaneous subscale||||0.4320
72337823|NCT00468845|144199119|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8843||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Pressing Spontaneous subscale||||0.8843
72337824|NCT00468845|144199119|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6215||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Paroxysmal pain subscale||||0.6215
72337825|NCT00468845|144199119|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2722||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Paroxysmal pain subscale||||0.2722
72337826|NCT00468845|144199119|SUPERIORITY_OR_OTHER_LEGACY|||||||0.55||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Evoked Pain subscale||||0.5500
72337827|NCT00468845|144199119|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9942||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Evoked Pain subscale||||0.9942
72427870|NCT02942004|144367030|SUPERIORITY||LS mean difference|0.07|STANDARD_ERROR_OF_MEAN|0.053||0.161|TWO_SIDED|95.0|-0.03|0.18|||MMRM|||Insight, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.18|-0.03|0.1610
72337828|NCT00468845|144199119|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0075||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Paresthesia/dysesthesia||||0.0075
72337829|NCT00468845|144199119|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1464||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Paresthesia/dysesthesia||||0.1464
72337830|NCT00468845|144199120|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9877||95.0|||||Cochran-Mantel-Haenszel|p-values are derived from CMH test adjusted for pooled centers and salpingo-oophorectomy strata||Incidence of chronic PS pain at Month 3 PS.||||0.9877
72337831|NCT00468845|144199120|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1334||95.0|||||Cochran-Mantel-Haenszel|p-values are derived from CMH test adjusted for pooled centers and salpingo-oophorectomy strata||Incidence of chronic PS pain at Month 3 PS.||||0.1334
72337832|NCT00468845|144199120|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3566||95.0|||||Cochran-Mantel-Haenszel|p-values are derived from CMH test adjusted for pooled centers and salpingo-oophorectomy strata||Incidence of chronic PS pain at Month 6 PS.||||0.3566
72337833|NCT00468845|144199120|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6262||95.0|||||Cochran-Mantel-Haenszel|p-values are derived from CMH test adjusted for pooled centers and salpingo-oophorectomy strata||Incidence of chronic PS pain at Month 6 PS.||||0.6262
72337834|NCT00468845|144199121|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9463||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Surgery day;||||0.9463
72337835|NCT00468845|144199121|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7347||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Surgery day;||||0.7347
72337836|NCT00468845|144199121|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4132||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 1 PS;||||0.4132
72337837|NCT00468845|144199121|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4929||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 1 PS;||||0.4929
72337838|NCT00468845|144199121|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6003||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 2 PS;||||0.6003
72337839|NCT00468845|144199121|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9343||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 2 PS;||||0.9343
72337840|NCT00468845|144199121|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3838||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 3 PS;||||0.3838
72337841|NCT00468845|144199121|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1351||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 3 PS;||||0.1351
72337842|NCT00468845|144199121|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3343||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 4 PS;||||0.3343
72337843|NCT00468845|144199121|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7948||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 4 PS;||||0.7948
72337844|NCT00468845|144199121|SUPERIORITY_OR_OTHER_LEGACY|||||||0.809||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 5 PS;||||0.8090
72337845|NCT00468845|144199121|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4035||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 5 PS;||||0.4035
72337846|NCT00468845|144199121|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6009||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Discharge||||0.6009
72337847|NCT00468845|144199121|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7597||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Discharge||||0.7597
72337848|NCT00468845|144199121|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7804||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 7||||0.7804
72337849|NCT00468845|144199121|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0463||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 7||||0.0463
72337850|NCT00468845|144199121|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4951||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 14||||0.4951
72337851|NCT00468845|144199121|SUPERIORITY_OR_OTHER_LEGACY|||||||0.303||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 14||||0.3030
72337852|NCT00468845|144199121|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0104||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 28||||0.0104
72337853|NCT00468845|144199121|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6978||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 28||||0.6978
72337854|NCT01049802|144199141|SUPERIORITY_OR_OTHER|||||||0.05|||||||Mixed Models Analysis|||||||0.05
72337855|NCT01049802|144199142|SUPERIORITY_OR_OTHER|||||||0.05|||||||Mixed Models Analysis|||||||0.05
72337856|NCT01049802|144199143|SUPERIORITY_OR_OTHER|||||||0.05|||||||Mixed Models Analysis|||||||0.05
72337857|NCT01049802|144199144|SUPERIORITY_OR_OTHER|||||||0.05|||||||Mixed Models Analysis|||||||0.05
72337858|NCT01049802|144199145|SUPERIORITY_OR_OTHER|||||||0.05|||||||Mixed Models Analysis|||||||0.05
72427871|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.03|STANDARD_ERROR_OF_MEAN|0.054||0.5763|TWO_SIDED|95.0|-0.14|0.08|||MMRM|||Insight, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.08|-0.14|0.5763
72337859|NCT05320393|144199154|OTHER|This study was not powered for formal hypothesis testing; analyses were intended for interpretation purposes only. Analysis was performed using the modified Intent-to-Treat population and regardless of responder status.||||||0.0109|TWO_SIDED|95.0|||||Log Rank|||The primary effectiveness endpoint was a measure of duration of effect, described by Kaplan-Meier curves and the median times, with associated 2-sided 95% confidence intervals for each treatment group.||||0.0109
72337860|NCT05693922|144199155|SUPERIORITY|||||||0.34|||||||ANOVA|||||||0.34
72337861|NCT05693922|144199156|SUPERIORITY|||||||0.54|||||||ANOVA|||||||0.54
72337862|NCT05693922|144199157|SUPERIORITY|||||||0.865|||||||ANOVA|||||||0.865
72337863|NCT03559699|144199176|OTHER|||||||0.0002|TWO_SIDED|95.0||||1-sided P-value|Binomial exact test|||||||0.0002
72337864|NCT02091284|144199243|OTHER||||||<|0.01||||||Two-way ANOVA with repeated measures followed by Bonferroni's multiple comparisons as post-hoc test and linear regression analyses. Additional comparisons between initial and final OCDS scores were done by paired t tests for each group.|ANOVA|||||||< 0.01
72337865|NCT02091284|144199243|OTHER||||||<|0.05|||||||t-test, 2 sided|||Additional comparisons between initial and final OCDS scores were done by paired t tests for each group, and differences between final and initial scores were compared between sham-tDCS and tDCS groups with unpaired t tests.||||<0.05
72337866|NCT01340937|144199300|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% confidence intervals of the Geometric Mean Concentration (GMC) ratio are within the margin 0.67 to 1.5|GMC Ratio (Lot A/Lot B)|0.91|||||TWO_SIDED|95.0|0.77|1.08|||||GMC ratio was adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine|||1.08|0.77|
72337867|NCT01340937|144199300|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% confidence intervals of the GMC ratio are within the margin 0.67 to 1.5|GMC Ratio (Lot A/Lot C)|0.86|||||TWO_SIDED|95.0|0.72|1.02|||||GMC ratio was adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine|||1.02|0.72|
72337868|NCT01340937|144199300|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% confidence intervals of the GMC ratio are within the margin 0.67 to 1.5|GMC Ratio (Lot B/Lot C)|0.94|||||TWO_SIDED|95.0|0.79|1.12|||||GMC ratio was adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine|||1.12|0.79|
72337869|NCT01340937|144199300|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 2-sided 95% CI of the GMC ratio is \>=0.67|GMC Ratio (Combined/Control)|1.63|||<|0.001|TWO_SIDED|95.0|1.35|1.98|||ANCOVA|GMC, GMC ratio, and p-value were adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine||||1.98|1.35|<0.001
72337870|NCT01340937|144199301|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% Confidence Intervals of the response rate difference are between -10% and 10%|Response Rate Difference (Lot A - Lot B)|-0.48|||||TWO_SIDED|95.0|-4.31|3.35|||||Response rate difference was stratified by brand of birth dose of Hepatitis B vaccine|Equivalence for titer \>=1 µg/mL||3.35|-4.31|
72337871|NCT01340937|144199301|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% Confidence Intervals of the response rate difference are between -10% and 10%|Response Rate Difference (Lot A - Lot C)|-1.62|||||TWO_SIDED|95.0|-5.38|2.12|||||Response rate difference was stratified by brand of birth dose of Hepatitis B vaccine|Equivalence for titer \>=1 µg/mL||2.12|-5.38|
72337872|NCT01340937|144199301|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% Confidence Intervals of the response rate difference are between -10% and 10%|Response Rate Difference (Lot B - Lot C)|-1.16|||||TWO_SIDED|95.0|-4.89|2.58|||||Response rate difference was stratified by brand of birth dose of Hepatitis B vaccine|Equivalence for titer \>=1 µg/mL||2.58|-4.89|
72337873|NCT01340937|144199301|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 95% CI of the response rate difference is \>= -10%|Response Rate Difference (Comb - Ctrl)|7.93|||<|0.001|TWO_SIDED|95.0|3.38|13.17|||Miettinen and Nurminen|Response rate, response rate difference and p-value were stratified by brand of birth dose of Hepatitis B vaccine||Non-inferiority for titer \>=1 µg/mL||13.17|3.38|<0.001
72337874|NCT01340937|144199301|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 95% CI of the response rate difference is \>= -5%|Response Rate Difference (Comb - Ctrl)|2.2|||<|0.001|TWO_SIDED|95.0|0.39|5.12|||Miettinen and Nurminen|Response rate, response rate difference and p-value were stratified by brand of birth dose of Hepatitis B vaccine||Non-inferiority for titer \>=0.15 µg/mL||5.12|0.39|<0.001
72337875|NCT01340937|144199302|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% confidence intervals of the GMC ratio are within the margin 0.67 to 1.5|GMC Ratio (Lot A/Lot B)|0.87|||||TWO_SIDED|95.0|0.76|0.98|||||GMC ratio was adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine|||0.98|0.76|
72427872|NCT02942004|144367030|SUPERIORITY||LS mean difference|0.1|STANDARD_ERROR_OF_MEAN|0.053||0.0599|TWO_SIDED|95.0|0.0|0.2|||MMRM|||Insight, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.20|0.00|0.0599
72427873|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.05|STANDARD_ERROR_OF_MEAN|0.054||0.3916|TWO_SIDED|95.0|-0.15|0.06|||MMRM|||Insight, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.06|-0.15|0.3916
72427874|NCT02942004|144367030|SUPERIORITY||LS mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.053||0.9602|TWO_SIDED|95.0|-0.1|0.11|||MMRM|||Insight, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.11|-0.10|0.9602
72427875|NCT02942004|144367030|SUPERIORITY||LS mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.055||0.9676|TWO_SIDED|95.0|-0.11|0.11|||MMRM|||Insight, Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.11|-0.11|0.9676
72427876|NCT02942004|144367030|SUPERIORITY||LS mean difference|0.02|STANDARD_ERROR_OF_MEAN|0.053||0.6397|TWO_SIDED|95.0|-0.08|0.13|||MMRM|||Insight, Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.13|-0.08|0.6397
72427877|NCT02942004|144367030|SUPERIORITY||LS mean difference|0.05|STANDARD_ERROR_OF_MEAN|0.054||0.34|TWO_SIDED|95.0|-0.05|0.16|||MMRM|||Insight, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.16|-0.05|0.3400
72427878|NCT02942004|144367030|SUPERIORITY||LS mean difference|0.05|STANDARD_ERROR_OF_MEAN|0.053||0.3472|TWO_SIDED|95.0|-0.05|0.15|||MMRM|||Insight, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.15|-0.05|0.3472
72427879|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.01|STANDARD_ERROR_OF_MEAN|0.054||0.916|TWO_SIDED|95.0|-0.11|0.1|||MMRM|||Insight, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.10|-0.11|0.9160
72427880|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.03|STANDARD_ERROR_OF_MEAN|0.053||0.5948|TWO_SIDED|95.0|-0.13|0.08|||MMRM|||Insight, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.08|-0.13|0.5948
72427881|NCT02942004|144367030|SUPERIORITY||LS mean difference|0.05|STANDARD_ERROR_OF_MEAN|0.054||0.3755|TWO_SIDED|95.0|-0.06|0.16|||MMRM|||Insight, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.16|-0.06|0.3755
72427882|NCT02942004|144367030|SUPERIORITY||LS mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.053||0.9752|TWO_SIDED|95.0|-0.11|0.1|||MMRM|||Insight, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.10|-0.11|0.9752
72427883|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.01|STANDARD_ERROR_OF_MEAN|0.054||0.9188|TWO_SIDED|95.0|-0.11|0.1|||MMRM|||Insight, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.10|-0.11|0.9188
72427884|NCT02942004|144367030|SUPERIORITY||LS mean difference|0.02|STANDARD_ERROR_OF_MEAN|0.053||0.6379|TWO_SIDED|95.0|-0.08|0.13|||MMRM|||Insight, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.13|-0.08|0.6379
72337876|NCT01340937|144199302|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% confidence intervals of the GMC ratio are within the margin 0.67 to 1.5|GMC Ratio (Lot A/Lot C)|0.85|||||TWO_SIDED|95.0|0.74|0.96|||||GMC ratio was adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine|||0.96|0.74|
72337877|NCT01340937|144199302|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% confidence intervals of the GMC ratio are within the margin 0.67 to 1.5|GMC Ratio (Lot B/Lot C)|0.98|||||TWO_SIDED|95.0|0.86|1.11|||||GMC ratio was adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine|||1.11|0.86|
72427885|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.04|STANDARD_ERROR_OF_MEAN|0.061||0.4967|TWO_SIDED|95.0|-0.16|0.08|||MMRM|||Insight, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.08|-0.16|0.4967
72427886|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.06|STANDARD_ERROR_OF_MEAN|0.059||0.3492|TWO_SIDED|95.0|-0.17|0.06|||MMRM|||Insight, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.06|-0.17|0.3492
72427887|NCT02942004|144367030|SUPERIORITY||LS mean difference|0.02|STANDARD_ERROR_OF_MEAN|0.062||0.7136|TWO_SIDED|95.0|-0.1|0.14|||MMRM|||Insight, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.14|-0.10|0.7136
72427888|NCT02942004|144367030|SUPERIORITY||LS mean difference|0.01|STANDARD_ERROR_OF_MEAN|0.059||0.8163|TWO_SIDED|95.0|-0.1|0.13|||MMRM|||Insight, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.13|-0.10|0.8163
72427889|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.06|STANDARD_ERROR_OF_MEAN|0.055||0.2825|TWO_SIDED|95.0|-0.17|0.05|||MMRM|||Insight, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.05|-0.17|0.2825
72427890|NCT02942004|144367030|SUPERIORITY||LS mean difference|-0.08|STANDARD_ERROR_OF_MEAN|0.054||0.1603|TWO_SIDED|95.0|-0.18|0.03|||MMRM|||Insight, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.03|-0.18|0.1603
72427891|NCT02942004|144367031|SUPERIORITY||LS mean difference|-6.85|STANDARD_ERROR_OF_MEAN|2.414||0.0054|TWO_SIDED|95.0|-11.64|-2.07|||MMRM|||Change at Hour 60: MMRM was used for analysis. The change from baseline in MADRS total score at each visit was the dependent variable. Treatment, baseline MADRS total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model. All explanatory variables including pooled center were treated as fixed effects.||-2.07|-11.64|0.0054
72427892|NCT02942004|144367031|SUPERIORITY||LS mean difference|-4.2|STANDARD_ERROR_OF_MEAN|2.35||0.0763|TWO_SIDED|95.0|-8.86|0.45|||MMRM|||Change at Hour 60: MMRM was used for analysis. The change from baseline in MADRS total score at each visit was the dependent variable. Treatment, baseline MADRS total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.45|-8.86|0.0763
72337878|NCT01340937|144199303|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% confidence intervals of the GMC ratio are within the margin 0.67 to 1.5|GMC Ratio (Lot A/Lot B)|0.95|||||TWO_SIDED|95.0|0.84|1.07|||||GMC ratio was adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine|||1.07|0.84|
72337879|NCT01340937|144199303|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% confidence intervals of the GMC ratio are within the margin 0.67 to 1.5|GMC Ratio (Lot A/Lot C)|0.97|||||TWO_SIDED|95.0|0.86|1.09|||||GMC ratio was adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine|||1.09|0.86|
72337880|NCT01340937|144199303|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% confidence intervals of the GMC ratio are within the margin 0.67 to 1.5|GMC Ratio (Lot B/Lot C)|1.02|||||TWO_SIDED|95.0|0.9|1.14|||||GMC ratio was adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine|||1.14|0.90|
72337881|NCT01340937|144199304|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% confidence intervals of the GMC ratio are within the margin 0.67 to 1.5|GMC Ratio (Lot A/Lot B)|0.97|||||TWO_SIDED|95.0|0.91|1.04|||||GMC ratio was adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine|||1.04|0.91|
72427893|NCT02942004|144367031|SUPERIORITY||LS mean difference|-4.3|STANDARD_ERROR_OF_MEAN|2.673||0.1101|TWO_SIDED|95.0|-9.6|0.99|||MMRM|||Change at Day 7: MMRM was used for analysis. The change from baseline in MADRS total score at each visit was the dependent variable. Treatment, baseline MADRS total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.99|-9.60|0.1101
72337882|NCT01340937|144199304|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% confidence intervals of the GMC ratio are within the margin 0.67 to 1.5|GMC Ratio (Lot A/Lot C)|1.02|||||TWO_SIDED|95.0|0.95|1.09|||||GMC ratio was adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine|||1.09|0.95|
72337883|NCT01340937|144199304|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% confidence intervals of the GMC ratio are within the margin 0.67 to 1.5|GMC Ratio (Lot B/Lot C)|1.05|||||TWO_SIDED|95.0|0.98|1.13|||||GMC ratio was adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine|||1.13|0.98|
72337884|NCT01340937|144199305|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% confidence intervals of the GMC ratio are within the margin 0.67 to 1.5|GMC Ratio (Lot A/Lot B)|1.03|||||TWO_SIDED|95.0|0.96|1.1|||||GMC ratio was adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine|||1.10|0.96|
72337885|NCT01340937|144199305|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% confidence intervals of the GMC ratio are within the margin 0.67 to 1.5|GMC Ratio (Lot A/Lot C)|1.02|||||TWO_SIDED|95.0|0.95|1.09|||||GMC ratio was adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine|||1.09|0.95|
72337886|NCT01340937|144199305|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% confidence intervals of the GMC ratio are within the margin 0.67 to 1.5|GMC Ratio (Lot B/Lot C)|0.99|||||TWO_SIDED|95.0|0.92|1.06|||||GMC ratio was adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine|||1.06|0.92|
72337887|NCT01340937|144199305|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 2-sided 95% CI of the GMC ratio is \>=0.67|GMC Ratio (Combined/Control)|1.2|||<|0.001|TWO_SIDED|95.0|1.11|1.29|||ANCOVA|GMC, GMC ratio, and p-value were adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine||Secondary analysis||1.29|1.11|<0.001
72337888|NCT01340937|144199306|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% confidence intervals of the GMC ratio are within the margin 0.67 to 1.5|GMC Ratio (Lot A/Lot B)|0.89|||||TWO_SIDED|95.0|0.83|0.96|||||GMC ratio was adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine|||0.96|0.83|
72337889|NCT01340937|144199306|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% confidence intervals of the GMC ratio are within the margin 0.67 to 1.5|GMC Ratio (Lot A/Lot C)|0.78|||||TWO_SIDED|95.0|0.72|0.83|||||GMC ratio was adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine|||0.83|0.72|
72337890|NCT01340937|144199306|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% confidence intervals of the GMC ratio are within the margin 0.67 to 1.5|GMC Ratio (Lot B/Lot C)|0.87|||||TWO_SIDED|95.0|0.81|0.94|||||GMC ratio was adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine|||0.94|0.81|
72337891|NCT01340937|144199306|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 2-sided 95% CI of the GMC ratio is \>=0.67|GMC Ratio (Combined/Control)|0.67||||0.419|TWO_SIDED|95.0|0.62|0.73|||ANCOVA|GMC, GMC ratio, and p-value were adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine||Secondary analysis||0.73|0.62|0.419
72337892|NCT01340937|144199307|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% confidence intervals of the GMC ratio are within the margin 0.67 to 1.5|GMC Ratio (Lot A/Lot B)|0.97|||||TWO_SIDED|95.0|0.87|1.09|||||GMC ratio was adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine|||1.09|0.87|
72337893|NCT01340937|144199307|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% confidence intervals of the GMC ratio are within the margin 0.67 to 1.5|GMC Ratio (Lot A/Lot C)|0.93|||||TWO_SIDED|95.0|0.83|1.05|||||GMC ratio was adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine|||1.05|0.83|
72337894|NCT01340937|144199307|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% confidence intervals of the GMC ratio are within the margin 0.67 to 1.5|GMC Ratio (Lot B/Lot C)|0.96|||||TWO_SIDED|95.0|0.85|1.08|||||GMC ratio was adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine|||1.08|0.85|
72337895|NCT01340937|144199307|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 2-sided 95% CI of the GMC ratio is \>=0.67|GMC Ratio (Combined/Control)|1.03|||<|0.001|TWO_SIDED|95.0|0.9|1.17|||ANCOVA|GMC, GMC ratio, and p-value were adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine||Secondary analysis||1.17|0.90|<0.001
72337896|NCT01340937|144199308|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% confidence intervals of the GMC ratio are within the margin 0.67 to 1.5|GMC Ratio (Lot A/Lot B)|0.78|||||TWO_SIDED|95.0|0.72|0.85|||||GMC ratio was adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine|||0.85|0.72|
72337897|NCT01340937|144199308|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% confidence intervals of the GMC ratio are within the margin 0.67 to 1.5|GMC Ratio (Lot A/Lot C)|0.8|||||TWO_SIDED|95.0|0.73|0.87|||||GMC ratio was adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine|||0.87|0.73|
72337898|NCT01340937|144199308|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% confidence intervals of the GMC ratio are within the margin 0.67 to 1.5|GMC Ratio (Lot B/Lot C)|1.02|||||TWO_SIDED|95.0|0.93|1.11|||||GMC ratio was adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine|||1.11|0.93|
72337899|NCT01340937|144199308|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 2-sided 95% CI of the GMC ratio is \>=0.67|GMC Ratio (Combined/Control)|1.51|||<|0.001|TWO_SIDED|95.0|1.37|1.66|||ANCOVA|GMC, GMC ratio, and p-value were adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine||Secondary analysis||1.66|1.37|<0.001
72337900|NCT01340937|144199309|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% confidence intervals of the Geometric Mean Titer (GMT) ratio are within the margin 0.67 to 1.5|GMT Ratio (Lot A/Lot B)|0.86|||||TWO_SIDED|95.0|0.76|0.96|||||GMT ratio was adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine|||0.96|0.76|
72369992|NCT02260180|144250384|SUPERIORITY||||||<|0.0001||||||No adjustment for multiple comparisons were made.|ANCOVA|Baseline PLA was the covariate. Comparisons were performed within the model using least-squares means and the common error term.||||||<0.0001
72337901|NCT01340937|144199309|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% confidence intervals of the GMT ratio are within the margin 0.67 to 1.5|GMT Ratio (Lot A/Lot C)|0.88|||||TWO_SIDED|95.0|0.79|0.99|||||GMT ratio was adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine|||0.99|0.79|
72337902|NCT01340937|144199309|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% confidence intervals of the GMT ratio are within the margin 0.67 to 1.5|GMT Ratio (Lot B/Lot C)|1.03|||||TWO_SIDED|95.0|0.92|1.15|||||GMT ratio was adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine|||1.15|0.92|
72337903|NCT01340937|144199310|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% confidence intervals of the GMT ratio are within the margin 0.67 to 1.5|GMT Ratio (Lot A/Lot B)|0.94|||||TWO_SIDED|95.0|0.84|1.05|||||GMT ratio was adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine|||1.05|0.84|
72337904|NCT01340937|144199310|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% confidence intervals of the GMT ratio are within the margin 0.67 to 1.5|GMT Ratio (Lot A/Lot C)|0.91|||||TWO_SIDED|95.0|0.82|1.02|||||GMT ratio was adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine|||1.02|0.82|
72337905|NCT01340937|144199310|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% confidence intervals of the GMT ratio are within the margin 0.67 to 1.5|GMT Ratio (Lot B/Lot C)|0.98|||||TWO_SIDED|95.0|0.87|1.09|||||GMT ratio was adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine|||1.09|0.87|
72337906|NCT01340937|144199311|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% confidence intervals of the GMT ratio are within the margin 0.67 to 1.5|GMT Ratio (Lot A/Lot B)|1.06|||||TWO_SIDED|95.0|0.92|1.22|||||GMT ratio was adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine|||1.22|0.92|
72337907|NCT01340937|144199311|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% confidence intervals of the GMT ratio are within the margin 0.67 to 1.5|GMT Ratio (Lot A/Lot C)|1.09|||||TWO_SIDED|95.0|0.95|1.26|||||GMT ratio was adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine|||1.26|0.95|
72337908|NCT01340937|144199311|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% confidence intervals of the GMT ratio are within the margin 0.67 to 1.5|GMT Ratio (Lot B/Lot C)|1.03|||||TWO_SIDED|95.0|0.9|1.19|||||GMT ratio was adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine|||1.19|0.90|
72337909|NCT01340937|144199312|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% Confidence Intervals of the response rate difference are between -10% and 10%|Response Rate Difference (Lot A - Lot B)|-0.34|||||TWO_SIDED|95.0|-1.23|0.3|||||Response rate difference was stratified by brand of birth dose of Hepatitis B vaccine|||0.30|-1.23|
72427894|NCT02942004|144367031|SUPERIORITY||LS mean difference|-1.31|STANDARD_ERROR_OF_MEAN|2.618||0.6167|TWO_SIDED|95.0|-6.5|3.87|||MMRM|||Change at Day 7: MMRM was used for analysis. The change from baseline in MADRS total score at each visit was the dependent variable. Treatment, baseline MADRS total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model. All explanatory variables including pooled center were treated as fixed effects.||3.87|-6.50|0.6167
72337910|NCT01340937|144199312|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% Confidence Intervals of the response rate difference are between -10% and 10%|Response Rate Difference (Lot A - Lot C)|-0.34|||||TWO_SIDED|95.0|-1.23|0.32|||||Response rate difference was stratified by brand of birth dose of Hepatitis B vaccine|||0.32|-1.23|
72337911|NCT01340937|144199312|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% Confidence Intervals of the response rate difference are between -10% and 10%|Response Rate Difference (Lot B - Lot C)|0.0|||||TWO_SIDED|95.0|-0.64|0.66|||||Response rate difference was stratified by brand of birth dose of Hepatitis B vaccine|||0.66|-0.64|
72337912|NCT01340937|144199312|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 95% CI of the response rate difference is \>= -10%|Response Rate Difference (Comb - Ctrl)|0.92|||<|0.001|TWO_SIDED|95.0|0.2|2.9|||Miettinen and Nurminen|Response rate, response rate difference and p-value were stratified by brand of birth dose of Hepatitis B vaccine||||2.90|0.20|<0.001
72337913|NCT01340937|144199313|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% Confidence Intervals of the response rate difference are between -10% and 10%|Response Rate Difference (Lot A - Lot B)|0.25|||||TWO_SIDED|95.0|-3.74|4.24|||||Response rate difference was stratified by brand of birth dose of Hepatitis B vaccine|||4.24|-3.74|
72337914|NCT01340937|144199313|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% Confidence Intervals of the response rate difference are between -10% and 10%|Response Rate Difference (Lot A - Lot C)|-1.35|||||TWO_SIDED|95.0|-5.26|2.57|||||Response rate difference was stratified by brand of birth dose of Hepatitis B vaccine|||2.57|-5.26|
72337915|NCT01340937|144199313|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% Confidence Intervals of the response rate difference are between -10% and 10%|Response Rate Difference (Lot B - Lot C)|-1.64|||||TWO_SIDED|95.0|-5.56|2.28|||||Response rate difference was stratified by brand of birth dose of Hepatitis B vaccine|||2.28|-5.56|
72337916|NCT01340937|144199313|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 95% CI of the response rate difference is \>= -10%|Response Rate Difference (Comb - Ctrl)|-2.35|||<|0.001|TWO_SIDED|95.0|-6.02|2.09|||Miettinen and Nurminen|Response rate, response rate difference and p-value were stratified by brand of birth dose of Hepatitis B vaccine||||2.09|-6.02|<0.001
72337917|NCT01340937|144199314|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% Confidence Intervals of the response rate difference are between -5% and 5%|Response Rate Difference (Lot A - Lot B)|-0.16|||||TWO_SIDED|95.0|-0.91|0.47|||||Response rate difference was stratified by brand of birth dose of Hepatitis B vaccine|||0.47|-0.91|
72337918|NCT01340937|144199314|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% Confidence Intervals of the response rate difference are between -5% and 5%|Response Rate Difference (Lot A - Lot C)|-0.16|||||TWO_SIDED|95.0|-0.9|0.47|||||Response rate difference was stratified by brand of birth dose of Hepatitis B vaccine|||0.47|-0.90|
72427895|NCT02942004|144367031|SUPERIORITY||LS mean difference|-5.64|STANDARD_ERROR_OF_MEAN|2.777||0.0447|TWO_SIDED|95.0|-11.14|-0.14|||MMRM|||Change at Day 30: MMRM was used for analysis. The change from baseline in MADRS total score at each visit was the dependent variable. Treatment, baseline MADRS total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.14|-11.14|0.0447
72337919|NCT01340937|144199314|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% Confidence Intervals of the response rate difference are between -5% and 5%|Response Rate Difference (Lot B - Lot C)|0.0|||||TWO_SIDED|95.0|-0.63|0.62|||||Response rate difference was stratified by brand of birth dose of Hepatitis B vaccine|||0.62|-0.63|
72427896|NCT02942004|144367031|SUPERIORITY||LS mean difference|-3.59|STANDARD_ERROR_OF_MEAN|2.726||0.1908|TWO_SIDED|95.0|-8.99|1.81|||MMRM|||Change at Day 30: MMRM was used for analysis. The change from baseline in MADRS total score at each visit was the dependent variable. Treatment, baseline MADRS total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model. All explanatory variables including pooled center were treated as fixed effects.||1.81|-8.99|0.1908
72427897|NCT02942004|144367032|SUPERIORITY||Odds Ratio (OR)|4.0||||0.0131|TWO_SIDED|95.0|1.3|11.7|||GEE method|||Hour 60: GEE method was used for analysis. CGI-I response at each visit was the dependent variable. Treatment, baseline CGI-S score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model.||11.7|1.3|0.0131
72427898|NCT02942004|144367032|SUPERIORITY||Odds Ratio (OR)|4.0||||0.0095|TWO_SIDED|95.0|1.4|11.6|||GEE method|||Hour 60: GEE method was used for analysis. CGI-I response at each visit was the dependent variable. Treatment, baseline CGI-S score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model.||11.6|1.4|0.0095
72427899|NCT02942004|144367032|SUPERIORITY||Odds Ratio (OR)|2.9||||0.0323|TWO_SIDED|95.0|1.1|7.5|||GEE method|||Day 7: GEE method was used for analysis. CGI-I response at each visit was the dependent variable. Treatment, baseline CGI-S score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model.||7.5|1.1|0.0323
72337920|NCT01340937|144199314|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 95% CI of the response rate difference is \>= -5%|Response Rate Difference (Comb - Ctrl)|1.28|||<|0.001|TWO_SIDED|95.0|0.46|3.33|||Miettinen and Nurminen|Response rate, response rate difference and p-value were stratified by brand of birth dose of Hepatitis B vaccine||||3.33|0.46|<0.001
72337921|NCT01340937|144199315|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% Confidence Intervals of the response rate difference are between -10% and 10%|Response Rate Difference (Lot A - Lot B)|1.73|||||TWO_SIDED|95.0|0.37|3.4|||||Response rate difference was stratified by brand of birth dose of Hepatitis B vaccine|||3.40|0.37|
72427900|NCT02942004|144367032|SUPERIORITY||Odds Ratio (OR)|2.2||||0.0931|TWO_SIDED|95.0|0.9|5.3|||GEE method|||Day 7: GEE method was used for analysis. CGI-I response at each visit was the dependent variable. Treatment, baseline CGI-S score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model.||5.3|0.9|0.0931
72427901|NCT02942004|144367032|SUPERIORITY||Odds Ratio (OR)|3.6||||0.0139|TWO_SIDED|95.0|1.3|10.0|||GEE method|||Day 30: GEE method was used for analysis. CGI-I response at each visit was the dependent variable. Treatment, baseline CGI-S score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model.||10.0|1.3|0.0139
72427902|NCT02942004|144367032|SUPERIORITY||Odds Ratio (OR)|2.6||||0.046|TWO_SIDED|95.0|1.0|6.9|||GEE method|||Day 30: GEE method was used for analysis. CGI-I response at each visit was the dependent variable. Treatment, baseline CGI-S score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model.||6.9|1.0|0.0460
72427903|NCT02942004|144367033|SUPERIORITY||LS mean difference|-1.13|STANDARD_ERROR_OF_MEAN|1.454||0.4389|TWO_SIDED|95.0|-4.01|1.75|||MMRM|||Change at Hour 60: MMRM was used for the analysis. The change from baseline in GAD-7 total score at each visit was the dependent variable. Treatment, baseline GAD-7 total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model. All explanatory variables including pooled center were treated as fixed effects.||1.75|-4.01|0.4389
72427904|NCT02942004|144367033|SUPERIORITY||LS mean difference|-1.05|STANDARD_ERROR_OF_MEAN|1.427||0.4645|TWO_SIDED|95.0|-3.88|1.78|||MMRM|||Change at Hour 60: MMRM was used for the analysis. The change from baseline in GAD-7 total score at each visit was the dependent variable. Treatment, baseline GAD-7 total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model. All explanatory variables including pooled center were treated as fixed effects.||1.78|-3.88|0.4645
72337922|NCT01340937|144199315|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% Confidence Intervals of the response rate difference are between -10% and 10%|Response Rate Difference (Lot A - Lot C)|0.36|||||TWO_SIDED|95.0|-0.77|1.63|||||Response rate difference was stratified by brand of birth dose of Hepatitis B vaccine|||1.63|-0.77|
72337923|NCT01340937|144199315|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% Confidence Intervals of the response rate difference are between -10% and 10%|Response Rate Difference (Lot B - Lot C)|-1.36|||||TWO_SIDED|95.0|-3.03|0.15|||||Response rate difference was stratified by brand of birth dose of Hepatitis B vaccine|||0.15|-3.03|
72337924|NCT01340937|144199315|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 95% CI of the response rate difference is \>= -10%|Response Rate Difference (Comb - Ctrl)|0.72|||<|0.001|TWO_SIDED|95.0|-0.59|3.14|||Miettinen and Nurminen|Response rate, response rate difference and p-value were stratified by brand of birth dose of Hepatitis B vaccine||||3.14|-0.59|<0.001
72337925|NCT01340937|144199316|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% Confidence Intervals of the response rate difference are between -10% and 10%|Response Rate Difference (Lot A - Lot B)|-1.35|||||TWO_SIDED|95.0|-5.17|2.47|||||Response rate difference was stratified by brand of birth dose of Hepatitis B vaccine|||2.47|-5.17|
72337926|NCT01340937|144199316|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% Confidence Intervals of the response rate difference are between -10% and 10%|Response Rate Difference (Lot A - Lot C)|-3.06|||||TWO_SIDED|95.0|-6.79|0.67|||||Response rate difference was stratified by brand of birth dose of Hepatitis B vaccine|||0.67|-6.79|
72337927|NCT01340937|144199316|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% Confidence Intervals of the response rate difference are between -10% and 10%|Response Rate Difference (Lot B - Lot C)|-1.71|||||TWO_SIDED|95.0|-5.37|1.94|||||Response rate difference was stratified by brand of birth dose of Hepatitis B vaccine|||1.94|-5.37|
72337928|NCT01340937|144199316|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 95% CI of the response rate difference is \>= -10%|Response Rate Difference (Comb - Ctrl)|-4.7|||<|0.001|TWO_SIDED|95.0|-7.73|-0.86|||Miettinen and Nurminen|Response rate, response rate difference and p-value were stratified by brand of birth dose of Hepatitis B vaccine||||-0.86|-7.73|<0.001
72337929|NCT01340937|144199317|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% Confidence Intervals of the response rate difference are between -10% and 10%|Response Rate Difference (Lot A - Lot B)|2.77|||||TWO_SIDED|95.0|-1.83|7.39|||||Response rate difference was stratified by brand of birth dose of Hepatitis B vaccine|||7.39|-1.83|
72337930|NCT01340937|144199317|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% Confidence Intervals of the response rate difference are between -10% and 10%|Response Rate Difference (Lot A - Lot C)|2.41|||||TWO_SIDED|95.0|-2.21|7.06|||||Response rate difference was stratified by brand of birth dose of Hepatitis B vaccine|||7.06|-2.21|
72337931|NCT01340937|144199317|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% Confidence Intervals of the response rate difference are between -10% and 10%|Response Rate Difference (Lot B - Lot C)|-0.36|||||TWO_SIDED|95.0|-5.14|4.42|||||Response rate difference was stratified by brand of birth dose of Hepatitis B vaccine|||4.42|-5.14|
72337932|NCT01340937|144199317|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 95% CI of the response rate difference is \>= -10%|Response Rate Difference (Comb - Ctrl)|3.28|||<|0.001|TWO_SIDED|95.0|-1.7|8.85|||Miettinen and Nurminen|Response rate, response rate difference and p-value were stratified by brand of birth dose of Hepatitis B vaccine||||8.85|-1.70|<0.001
72337933|NCT01340937|144199318|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% Confidence Intervals of the response rate difference are between -10% and 10%|Response Rate Difference (Lot A - Lot B)|-4.12|||||TWO_SIDED|95.0|-7.69|-0.63|||||Response rate difference was stratified by brand of birth dose of Hepatitis B vaccine|||-0.63|-7.69|
72337934|NCT01340937|144199318|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% Confidence Intervals of the response rate difference are between -10% and 10%|Response Rate Difference (Lot A - Lot C)|-4.17|||||TWO_SIDED|95.0|-7.75|-0.66|||||Response rate difference was stratified by brand of birth dose of Hepatitis B vaccine|||-0.66|-7.75|
72337935|NCT01340937|144199318|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% Confidence Intervals of the response rate difference are between -10% and 10%|Response Rate Difference (Lot B - Lot C)|-0.07|||||TWO_SIDED|95.0|-3.32|3.2|||||Response rate difference was stratified by brand of birth dose of Hepatitis B vaccine|||3.20|-3.32|
72337936|NCT01340937|144199318|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 95% CI of the response rate difference is \>= -10%|Response Rate Difference (Comb - Ctrl)|2.85|||<|0.001|TWO_SIDED|95.0|-0.85|7.36|||Miettinen and Nurminen|Response rate, response rate difference and p-value were stratified by brand of birth dose of Hepatitis B vaccine||||7.36|-0.85|<0.001
72337937|NCT01340937|144199319|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% Confidence Intervals of the response rate difference are between -5% and 5%|Response Rate Difference (Lot A - Lot B)|0.0|||||TWO_SIDED|95.0|-0.61|0.61|||||Response rate difference was stratified by brand of birth dose of Hepatitis B vaccine|||0.61|-0.61|
72337938|NCT01340937|144199319|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% Confidence Intervals of the response rate difference are between -5% and 5%|Response Rate Difference (Lot A - Lot C)|0.0|||||TWO_SIDED|95.0|-0.61|0.61|||||Response rate difference was stratified by brand of birth dose of Hepatitis B vaccine|||0.61|-0.61|
72337939|NCT01340937|144199319|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% Confidence Intervals of the response rate difference are between -5% and 5%|Response Rate Difference (Lot B - Lot C)|0.0|||||TWO_SIDED|95.0|-0.61|0.61|||||Response rate difference was stratified by brand of birth dose of Hepatitis B vaccine|||0.61|-0.61|
72337940|NCT01340937|144199319|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 95% CI of the response rate difference is \>= -5%|Response Rate Difference (Comb - Ctrl)|0.66|||<|0.001|TWO_SIDED|95.0|0.18|2.36|||Miettinen and Nurminen|Response rate, response rate difference and p-value were stratified by brand of birth dose of Hepatitis B vaccine||||2.36|0.18|<0.001
72337941|NCT01340937|144199320|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% Confidence Intervals of the response rate difference are between -5% and 5%|Response Rate Difference (Lot A - Lot B)|0.0|||||TWO_SIDED|95.0|-0.61|0.61|||||Response rate difference was stratified by brand of birth dose of Hepatitis B vaccine|||0.61|-0.61|
72337942|NCT01340937|144199320|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% Confidence Intervals of the response rate difference are between -5% and 5%|Response Rate Difference (Lot A - Lot C)|0.0|||||TWO_SIDED|95.0|-0.61|0.6|||||Response rate difference was stratified by brand of birth dose of Hepatitis B vaccine|||0.60|-0.61|
72337943|NCT01340937|144199320|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% Confidence Intervals of the response rate difference are between -5% and 5%|Response Rate Difference (Lot B - Lot C)|0.0|||||TWO_SIDED|95.0|-0.61|0.6|||||Response rate difference was stratified by brand of birth dose of Hepatitis B vaccine|||0.60|-0.61|
72337944|NCT01340937|144199320|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 95% CI of the response rate difference is \>= -5%|Response Rate Difference (Comb - Ctrl)|0.0|||<|0.001|TWO_SIDED|95.0|-0.2|1.24|||Miettinen and Nurminen|Response rate, response rate difference and p-value were stratified by brand of birth dose of Hepatitis B vaccine||||1.24|-0.20|<0.001
72427905|NCT02942004|144367033|SUPERIORITY||LS mean difference|-2.56|STANDARD_ERROR_OF_MEAN|1.356||0.0622|TWO_SIDED|95.0|-5.24|0.13|||MMRM|||Change at Day 7: MMRM was used for the analysis. The change from baseline in GAD-7 total score at each visit was the dependent variable. Treatment, baseline GAD-7 total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.13|-5.24|0.0622
72427906|NCT02942004|144367033|SUPERIORITY||LS mean difference|0.25|STANDARD_ERROR_OF_MEAN|1.338||0.8495|TWO_SIDED|95.0|-2.4|2.91|||MMRM|||Change at Day 7: MMRM was used for the analysis. The change from baseline in GAD-7 total score at each visit was the dependent variable. Treatment, baseline GAD-7 total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model. All explanatory variables including pooled center were treated as fixed effects.||2.91|-2.40|0.8495
72427907|NCT02942004|144367033|SUPERIORITY||LS mean difference|-0.6|STANDARD_ERROR_OF_MEAN|1.59||0.7063|TWO_SIDED|95.0|-3.75|2.55|||MMRM|||Change at Day 14: MMRM was used for the analysis. The change from baseline in GAD-7 total score at each visit was the dependent variable. Treatment, baseline GAD-7 total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model. All explanatory variables including pooled center were treated as fixed effects.||2.55|-3.75|0.7063
72427908|NCT02942004|144367033|SUPERIORITY||LS mean difference|-0.11|STANDARD_ERROR_OF_MEAN|1.552||0.9434|TWO_SIDED|95.0|-3.19|2.97|||MMRM|||Change at Day 14: MMRM was used for the analysis. The change from baseline in GAD-7 total score at each visit was the dependent variable. Treatment, baseline GAD-7 total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model. All explanatory variables including pooled center were treated as fixed effects.||2.97|-3.19|0.9434
72427909|NCT02942004|144367033|SUPERIORITY||LS mean difference|-0.06|STANDARD_ERROR_OF_MEAN|1.608||0.9701|TWO_SIDED|95.0|-3.25|3.13|||MMRM|||Change at Day 21: MMRM was used for the analysis. The change from baseline in GAD-7 total score at each visit was the dependent variable. Treatment, baseline GAD-7 total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model. All explanatory variables including pooled center were treated as fixed effects.||3.13|-3.25|0.9701
72427910|NCT02942004|144367033|SUPERIORITY||LS mean difference|-0.76|STANDARD_ERROR_OF_MEAN|1.566||0.6307|TWO_SIDED|95.0|-3.86|2.35|||MMRM|||Change at Day 21: MMRM was used for the analysis. The change from baseline in GAD-7 total score at each visit was the dependent variable. Treatment, baseline GAD-7 total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model. All explanatory variables including pooled center were treated as fixed effects.||2.35|-3.86|0.6307
72427911|NCT02942004|144367033|SUPERIORITY||LS mean difference|-2.02|STANDARD_ERROR_OF_MEAN|1.488||0.1767|TWO_SIDED|95.0|-4.97|0.93|||MMRM|||Change at Day 30: MMRM was used for the analysis. The change from baseline in GAD-7 total score at each visit was the dependent variable. Treatment, baseline GAD-7 total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.93|-4.97|0.1767
72427912|NCT02942004|144367033|SUPERIORITY||LS mean difference|-1.46|STANDARD_ERROR_OF_MEAN|1.468||0.3236|TWO_SIDED|95.0|-4.37|1.45|||MMRM|||Change at Day 30: MMRM was used for the analysis. The change from baseline in GAD-7 total score at each visit was the dependent variable. Treatment, baseline GAD-7 total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model. All explanatory variables including pooled center were treated as fixed effects.||1.45|-4.37|0.3236
72427913|NCT01448044|144367049|SUPERIORITY_OR_OTHER||difference in percentages|38.85|||<|0.0001|TWO_SIDED|95.0|21.703|55.997||The pvalue was based on the CochranMantelHaenszel (CMH) test, stratified by IL28B host genotype, geography, and baseline cirrhosis status.|Cochran-Mantel-Haenszel|||||55.997|21.703|<0.0001
72427914|NCT03688711|144367066|SUPERIORITY||||||<|0.0001|||||||Log Rank|||The recovery rates of dasiglucagon and placebo were evaluated using a Kaplan Meier (KM) approach, with treatment group as a stratification factor. Differences between the KM curves (dasiglucagon versus placebo) were evaluated inferentially using pairwise two-sided log-rank tests stratified by injection site.||||<0.0001
72427915|NCT03688711|144367067|SUPERIORITY|||||||0.0012|||||||Fisher Exact|||Assessed at 30 minutes. The recovery rates of dasiglucagon and placebo were compared at each time point using a Fisher's exact test. Testing followed an a priori defined hierarchical inferential test order, proceeding until the first failure to reject the null hypothesis comparing dasiglucagon versus placebo.||||0.0012
72427916|NCT03688711|144367067|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||Assessed at 20 minutes. The recovery rates of dasiglucagon and placebo were compared at each time point using a Fisher's exact test. Testing followed an a priori defined hierarchical inferential test order, proceeding until the first failure to reject the null hypothesis comparing dasiglucagon versus placebo.||||<0.0001
72337945|NCT01340937|144199321|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% Confidence Intervals of the response rate difference are between -5% and 5%|Response Rate Difference (Lot A - Lot B)|0.0|||||TWO_SIDED|95.0|-0.61|0.61|||||Response rate difference was stratified by brand of birth dose of Hepatitis B vaccine|||0.61|-0.61|
72427917|NCT03688711|144367067|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||Assessed at 15 minutes. The recovery rates of dasiglucagon and placebo were compared at each time point using a Fisher's exact test. Testing followed an a priori defined hierarchical inferential test order, proceeding until the first failure to reject the null hypothesis comparing dasiglucagon versus placebo.||||<0.0001
72427918|NCT03688711|144367067|SUPERIORITY|||||||0.0006|||||||Fisher Exact|||Assessed at 10 minutes. The recovery rates of dasiglucagon and placebo were compared at each time point using a Fisher's exact test. Testing followed an a priori defined hierarchical inferential test order, proceeding until the first failure to reject the null hypothesis comparing dasiglucagon versus placebo.||||0.0006
72427919|NCT03688711|144367068|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||Change from baseline in plasma glucose at 30 minutes after investigational product injection was calculated using nominal sampling times and analyzed using an analysis of variance model with treatment, age group and injection site for each endpoint. Testing followed an a priori defined hierarchical inferential test order, proceeding until the first failure to reject the null hypothesis comparing dasiglucagon versus placebo.||||<0.0001
72427920|NCT03688711|144367068|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||Change from baseline in plasma glucose at 20 minutes after investigational product injection was calculated using nominal sampling times and analyzed using an analysis of variance model with treatment, age group and injection site for each endpoint. Testing followed an a priori defined hierarchical inferential test order, proceeding until the first failure to reject the null hypothesis comparing dasiglucagon versus placebo.||||<0.0001
72427921|NCT03688711|144367068|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||Change from baseline in plasma glucose at 15 minutes after investigational product injection was calculated using nominal sampling times and analyzed using an analysis of variance model with treatment, age group and injection site for each endpoint. Testing followed an a priori defined hierarchical inferential test order, proceeding until the first failure to reject the null hypothesis comparing dasiglucagon versus placebo.||||<0.0001
72427922|NCT03688711|144367068|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||Change from baseline in plasma glucose at 10 minutes after investigational product injection was calculated using nominal sampling times and analyzed using an analysis of variance model with treatment, age group and injection site for each endpoint. Testing followed an a priori defined hierarchical inferential test order, proceeding until the first failure to reject the null hypothesis comparing dasiglucagon versus placebo.||||<0.0001
72427923|NCT03688711|144367069|SUPERIORITY||||||<|0.0001|||||||Log Rank|||Evaluated using a Kaplan Meier (KM) approach, with treatment group as a stratification factor, analogous to that used for the primary endpoint analysis. Differences between the KM curves (dasiglucagon versus placebo) were evaluated inferentially using pairwise two-sided log-rank tests. Subjects whose time to first plasma glucose concentration ≥70 mg/dL (3.9 mmol/L) was not met within 45 minutes post-dosing were censored, at the time of the last valid plasma glucose measurement up to 45 minutes.||||<0.0001
72427924|NCT03688711|144367070|SUPERIORITY||Odds Ratio (OR)|4.05|||<|0.0001|TWO_SIDED|95.0|2.71|6.05|||ANCOVA|||The analysis was an analysis of covariance (ANCOVA) model with treatment group as factor and the baseline of the dependent variable plasma glucose as a covariate.||6.05|2.71|<0.0001
72427925|NCT04675242|144367078|SUPERIORITY||Mean Difference (Final Values)|1.9||||0.4434|TWO_SIDED|95.0|-11.5|15.3|||Fisher Exact|||Difference in the proportion of study eyes with complete cure||15.3|-11.5|0.4434
72427926|NCT04675242|144367079|SUPERIORITY||Mean Difference (Final Values)|-3.7||||0.2105|TWO_SIDED|95.0|-9.5|2.1|||ANCOVA|adjusted for baseline eye dryness VAS score||Difference in the change from baseline between treatment groups||2.1|-9.5|0.2105
72427927|NCT04675242|144367080|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.5936|TWO_SIDED|95.0|-0.2|0.1|||ANCOVA|adjusted for baseline eye dryness VAS score||Difference in the mean change from baseline||0.1|-0.2|0.5936
72427928|NCT03912220|144367082|SUPERIORITY|||||||0.33|||||||Wilcoxon (Mann-Whitney)|||||||0.33
72427929|NCT03912220|144367083|SUPERIORITY|||||||0.54|||||||Wilcoxon (Mann-Whitney)|||||||0.54
72427930|NCT03560245|144367085|EQUIVALENCE|"The change from baseline to Week 13 in the SIB total score was summarized descriptively and compared using Analysis of Covariance (ANCOVA) adjusted for baseline SIB total score.~If the normality assumption was not met, a non-parametric method or a rank-ANCOVA analysis (i.e., an ANCOVA analysis on rank-transformed data) was to be used."||||||0.373|||||||t-test, 2 sided|||||||0.3730
72427931|NCT03216902|144367091|SUPERIORITY|Claim superiority of DE-126 compare to Placebo at 3 timepoints (9:00, 13:00 and 17:00)|||||<|0.0001||||||P value is adjusted for multiple comparisons using Hochberg step-up procedure.|t-test, 2 sided|||This endpoint is to test if one of four concentrations of DE-126 is superior to the placebo in lowering IOP at each specified timepoint (9:00, 13:00 and 17:00) at Week 6 compared to baseline. Therefore, 0.005% Latanoprost group is not included in the analysis.||||<0.0001
72427932|NCT03216902|144367091|SUPERIORITY|Claim superiority of DE-126 compare to Placebo at 3 timepoints (9:00, 13:00 and 17:00)|||||<|0.0001||||||P value is adjusted for multiple comparisons using Hochberg step-up procedure.|t-test, 2 sided|||This endpoint is to test if one of four concentrations of DE-126 is superior to the placebo in lowering IOP at each specified timepoint (9:00, 13:00 and 17:00) at Week 6 compared to baseline. Therefore, 0.005% Latanoprost group is not included in the analysis.||||<0.0001
72427933|NCT03216902|144367091|SUPERIORITY|Claim superiority of DE-126 compare to Placebo at 3 timepoints (9:00, 13:00 and 17:00)|||||<|0.0001||||||P value is adjusted for multiple comparisons using Hochberg step-up procedure.|t-test, 2 sided|||This endpoint is to test if one of four concentrations of DE-126 is superior to the placebo in lowering IOP at each specified timepoint (9:00, 13:00 and 17:00) at Week 6 compared to baseline. Therefore, 0.005% Latanoprost group is not included in the analysis.||||<0.0001
72427934|NCT03216902|144367091|SUPERIORITY|Claim superiority of DE-126 compare to Placebo at 3 timepoints (9:00, 13:00 and 17:00)|||||<|0.0001||||||P value is adjusted for multiple comparisons using Hochberg step-up procedure.|t-test, 2 sided|||This endpoint is to test if one of four concentrations of DE-126 is superior to the placebo in lowering IOP at each specified timepoint (9:00, 13:00 and 17:00) at Week 6 compared to baseline. Therefore, 0.005% Latanoprost group is not included in the analysis.||||<0.0001
72427935|NCT03662360|144367105|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||The Mann-Whitney test has been used to evaluate the statistical significance of the difference between the variations in scores (T3 - T1) regarding the two interest groups of patients (control and treated).||||<0.001
72427936|NCT03662360|144367106|SUPERIORITY||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||The Mann-Whitney test has been used to evaluate the statistical significance of the difference between the variations scores in T3 and T1, concerning the distress of the professional caregivers in the two intereste groups of patients||||<0.01
72427937|NCT01850082|144367107|SUPERIORITY||Hazard Ratio (HR)|1.12||||0.47|TWO_SIDED|95.0|0.83|1.51|||Regression, Cox|||||1.51|0.83|0.47
72427938|NCT01850082|144367108|SUPERIORITY|||||||0.821|||||||Chi-squared|||||||0.821
72427939|NCT01850082|144367109|SUPERIORITY||||||>|0.99|||||||Chi-squared|||||||>0.99
72427940|NCT01850082|144367110|SUPERIORITY||Hazard Ratio (HR)|0.923||||0.517|TWO_SIDED|95.0|0.724|1.176|||Regression, Cox|||||1.176|0.724|0.517
72427941|NCT02058290|144367131|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||||||<0.0001
72427942|NCT02058290|144367132|SUPERIORITY_OR_OTHER|||||||0.2612|||||||ANOVA|||||||0.2612
72427943|NCT02058290|144367133|SUPERIORITY_OR_OTHER|||||||0.0019|||||||Log Rank|||||||0.0019
72427944|NCT01625910|144367136|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.06|STANDARD_ERROR_OF_MEAN|0.05|||TWO_SIDED|95.0|-0.1|0.21||||||Baseline data by group assignment status (intervention or control) using means of the calculated BMI z-scores (U.S. CDC-2000 growth charts) implemented by applying the published LMS (shape, median, and scale) age- and sex/gender-specific parameters. Because of random assignment of a reasonably large number of children, an unadjusted analysis of change in outcomes between intervention and control groups is presented as well as the covariate-adjusted analysis of differences in changes.||0.21|-0.10|
72427945|NCT01625910|144367137|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.17|STANDARD_ERROR_OF_MEAN|0.2|||TWO_SIDED|95.0|-0.74|0.4||||||unadjusted net difference between groups||0.40|-0.74|
72427946|NCT02959138|144367189|OTHER|The test-to-reference ratio (geometric least squares mean (GLSM) ratio) and associated 90% CI were calculated by taking the exponential of the point estimate and the corresponding lower and upper limits, which was consistent with the two 1-sided tests approach.|GLSM ratio|111.68|||||TWO_SIDED|90.0|86.94|143.47||||||The Estimate statement was used to produce the point estimate and the corresponding 90% confidence interval of the difference in PK parameters of interest on a logarithmic scale.||143.47|86.94|
72427947|NCT02959138|144367189|OTHER|The test-to-reference ratio GLSM ratio and associated 90% CI were calculated by taking the exponential of the point estimate and the corresponding lower and upper limits, which was consistent with the two 1-sided tests approach.|GLSM ratio|107.04|||||TWO_SIDED|90.0|78.47|146.02||||||The Estimate statement was used to produce the point estimate and the corresponding 90% CI of the difference in PK parameters of interest on a logarithmic scale.||146.02|78.47|
72337946|NCT01340937|144199321|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% Confidence Intervals of the response rate difference are between -5% and 5%|Response Rate Difference (Lot A - Lot C)|0.0|||||TWO_SIDED|95.0|-0.61|0.61|||||Response rate difference was stratified by brand of birth dose of Hepatitis B vaccine|||0.61|-0.61|
72337947|NCT01340937|144199321|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% Confidence Intervals of the response rate difference are between -5% and 5%|Response Rate Difference (Lot B - Lot C)|0.0|||||TWO_SIDED|95.0|-0.61|0.61|||||Response rate difference was stratified by brand of birth dose of Hepatitis B vaccine|||0.61|-0.61|
72427948|NCT02959138|144367190|OTHER|The test-to-reference ratio GLSM ratio and associated 90% CI were calculated by taking the exponential of the point estimate and the corresponding lower and upper limits, which was consistent with the two 1-sided tests approach.|GLSM ratio|111.92|||||TWO_SIDED|90.0|86.92|144.12||||||The Estimate statement was used to produce the point estimate and the corresponding 90% CI of the difference in PK parameters of interest on a logarithmic scale.||144.12|86.92|
72427949|NCT02959138|144367190|OTHER|The test-to-reference ratio GLSM ratio and associated 90% CI were calculated by taking the exponential of the point estimate and the corresponding lower and upper limits, which was consistent with the two 1-sided tests approach.|GLSM ratio|107.69|||||TWO_SIDED|90.0|79.63|145.65||||||The Estimate statement was used to produce the point estimate and the corresponding 90% CI of the difference in PK parameters of interest on a logarithmic scale.||145.65|79.63|
72337948|NCT01340937|144199321|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 95% CI of the response rate difference is \>= -5%|Response Rate Difference (Comb - Ctrl)|0.33|||<|0.001|TWO_SIDED|95.0|0.05|1.85|||Miettinen and Nurminen|Response rate, response rate difference and p-value were stratified by brand of birth dose of Hepatitis B vaccine||||1.85|0.05|<0.001
72427950|NCT02959138|144367191|OTHER|The test-to-reference ratio GLSM ratio and associated 90% CI were calculated by taking the exponential of the point estimate and the corresponding lower and upper limits, which was consistent with the two 1-sided tests approach.|GLSM ratio|102.0|||||TWO_SIDED|90.0|81.42|127.79||||||The Estimate statement was used to produce the point estimate and the corresponding 90% CI of the difference in PK parameters of interest on a logarithmic scale.||127.79|81.42|
72427951|NCT02959138|144367191|OTHER|The test-to-reference ratio GLSM ratio and associated 90% CI were calculated by taking the exponential of the point estimate and the corresponding lower and upper limits, which was consistent with the two 1-sided tests approach.|GLSM ratio|87.8|||||TWO_SIDED|90.0|68.14|113.13||||||The Estimate statement was used to produce the point estimate and the corresponding 90% CI of the difference in PK parameters of interest on a logarithmic scale.||113.13|68.14|
72427952|NCT01946243|144367201|SUPERIORITY_OR_OTHER|||||||0.0029|TWO_SIDED||||||t-test, 2 sided|||Paired t-test to test whether the change is equal to zero or not.||||0.0029
72427953|NCT01946243|144367202|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority demonstrated if the lower bound of the one-sided 97.5% confidence interval is greater than -3%.|Mean Difference (Net)|4.2|||||ONE_SIDED|97.5|2.7||||||Units: Percent Accuracy||||2.7|
72427954|NCT01946243|144367203|SUPERIORITY_OR_OTHER||lower bound of two-sided 95% CI|0.06|||||TWO_SIDED|95.0|0.018|0.112||||||Superiority demonstrated if lower bound of two-sided 95% confidence interval (CI) greater than 0, for the change in kappa statistic.||0.112|0.018|
72427955|NCT01946243|144367204|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority demonstrated if the lower bound of the one-sided 97.5% confidence interval is greater than -3%.|Mean Difference (Net)|2.3|||||ONE_SIDED|97.5|0.8||||||Units: Percent Accuracy||||0.8|
72337949|NCT01340937|144199322|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 2-sided 95% CI of the GMC ratio is \>=0.67|GMC Ratio (Combined/Control)|1.07|||<|0.001|TWO_SIDED|95.0|0.98|1.17|||Analysis of Covariance|GMC, GMC ratio, and p-value were adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine||||1.17|0.98|<0.001
72427956|NCT01946243|144367205|SUPERIORITY_OR_OTHER||lower bound of two-sided 95% CI|0.07||||0.028|TWO_SIDED|95.0|0.007|0.125|||Monte Carlo test|||Superiority demonstrated if lower bound of two-sided 95% CI greater than 0, for the change in kappa statistic.||0.125|0.007|0.0280
72337950|NCT01340937|144199323|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 2-sided 95% CI of the GMC ratio is \>=0.67|GMC Ratio (Combined/Control)|0.86|||<|0.001|TWO_SIDED|95.0|0.79|0.95|||ANCOVA|GMC, GMC ratio, and p-value were adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine||||0.95|0.79|<0.001
72337951|NCT01340937|144199324|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 2-sided 95% CI of the GMC ratio is \>=0.67|GMC Ratio (Combined/Control)|0.74||||0.035|TWO_SIDED|95.0|0.66|0.83|||ANCOVA|GMC, GMC ratio, and p-value were adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine||||0.83|0.66|0.035
72427957|NCT01946243|144367206|SUPERIORITY_OR_OTHER|||||||0.0025|TWO_SIDED||||||t-test, 2 sided|||Paired t-test to test whether the change is equal to zero or not.||||0.0025
72427958|NCT01189890|144367208|NON_INFERIORITY_OR_EQUIVALENCE|The predefined non-inferiority margin was 0.4%.|Difference in LS Means|0.19|||||TWO_SIDED|95.0|0.03|0.34|||ANCOVA|Controlled for treatment, estimated glomerular filtration rate (eGFR) stratum, age stratum, and baseline HbA1C.||||0.34|0.03|
72427959|NCT01189890|144367209|SUPERIORITY_OR_OTHER||Difference in Percent Incidence|-3.9||||0.009|TWO_SIDED|95.0|-7.5|-1.2|||Miettinen & Nurminen|Stratified by estimated glomerular filtration rate (eGFR) stratum and age stratum.||||-1.2|-7.5|0.009
72427960|NCT01189890|144367212|SUPERIORITY_OR_OTHER||Difference in LS Means|6.7|||||TWO_SIDED|95.0|0.7|12.7|||ANCOVA|Controlled for treatment, eGFR stratum, age stratum, and baseline FPG.||||12.7|0.7|
72427961|NCT01189890|144367213|SUPERIORITY_OR_OTHER||Relative Risk|0.7|||||TWO_SIDED|95.0|0.6|0.9|||Miettinen & Nurminen|Stratified by eGFR stratum and age stratum.||||0.9|0.6|
72427962|NCT01189890|144367214|SUPERIORITY_OR_OTHER||Relative Risk|0.4|||||TWO_SIDED|95.0|0.3|0.7|||Miettinen & Nurminen|Stratified by eGFR stratum and age stratum.||||0.7|0.3|
72427963|NCT01189890|144367215|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.7||||0.011|TWO_SIDED|95.0|-1.3|-0.2|||ANCOVA|Controlled for treatment, eGFR stratum, age stratum, and baseline body weight.||||-0.2|-1.3|0.011
72427964|NCT00900627|144367240|SUPERIORITY_OR_OTHER||Maximum Tolerated Dose|40.0|||||||||||||Dosing started at 160mg. Based on the data seen, 240mg with 33% patients with DLTs, 120mg with 50% patients with DLTs, 80mg with 33% of patients with DLTs and 40mg with 0% patients with DLTs, 40mg was deemed the maximum tolerated dose.|A tolerated dose was defined as one where ≤25% of the patients experienced a DLT. If a dose was tolerated, an increased dose was to be investigated in another group of 3-6 evaluable patients. A non-tolerated dose was defined as one where \>25% of the patients experience a DLT. If a dose was non tolerated, a decreased/intermediate dose could be investigated in another group of 3-6 evaluable patients. The maximum tolerated dose was determined as the maximum dose level that was defined as tolerated.||||
72427965|NCT00900627|144367241|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.08||||0.679|TWO_SIDED|95.0|0.76|1.52||Statistical significance threshold at this analysis was 5%|Cox Proportional Hazard model|Cox PH test with terms for treatment , prior taxane, hormone receptor status, prior chemotherapy for breast cancer and AZD8931 diagnostic test|The Hazard Ratio is for AZD8931 40mg + paclitaxel / Placebo + paclitaxel, ie a hazard ratio \<1 favours AZD8931 40mg + paclitaxel|Originally, 166 patients were to be randomised to observe at least 133 progression events, based on HR=0.67, 80% power, 2-sided 5% significant level and a median of 6 months for the placebo arm. After 190 patients were randomised, the analysis was agreed to be performed at an similar level of maturity (70%) as originally planned (72%), after approximately 133 events.||1.52|0.76|0.679
72337952|NCT01340937|144199325|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 2-sided 95% CI of the GMC ratio is \>=0.67|GMC Ratio (Combined/Control)|1.31|||<|0.001|TWO_SIDED|95.0|1.17|1.46|||ANCOVA|GMC, GMC ratio, and p-value were adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine||||1.46|1.17|<0.001
72337953|NCT01340937|144199326|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 95% CI of the response rate difference is \>= -10%|Response Rate Difference (Comb - Ctrl)|0.12|||<|0.001|TWO_SIDED|95.0|-1.11|2.58|||Miettinen and Nurminen|Response rate, response rate difference and p-value were stratified by brand of birth dose of Hepatitis B vaccine||||2.58|-1.11|<0.001
72427966|NCT00900627|144367242|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.02||||0.026|TWO_SIDED|95.0|1.09|3.75||Statistical significance threshold at this analysis was 5%|Logistic Regression|Logistic reg. model with terms for treatment, prior taxane, hormone receptor status, prior chemotherapy for breast cancer and AZD8931 diagnostic test|The odds Ratio is for AZD8931 40mg + paclitaxel / Placebo + paclitaxel, ie a odds ratio \<1 favours AZD8931 40mg + paclitaxel|Originally, 166 patients were to be randomised to observe at least 133 progression events, based on HR=0.67, 80% power, 2-sided 5% significant level and a median of 6 months for the placebo arm. After 190 patients were randomised, the analysis was agreed to be performed at an similar level of maturity (70%) as originally planned (72%), after approximately 133 events.||3.75|1.09|0.026
72427967|NCT00900627|144367243|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.15||||0.607|TWO_SIDED|95.0|0.67|2.01||Statistical significance threshold at this analysis was 5%|Cox proportional hazard model|Cox PH test with terms for treatment , prior taxane, hormone receptor status, prior chemotherapy for breast cancer|The Hazard Ratio is for AZD8931 40mg + paclitaxel / Placebo + paclitaxel, ie a hazard ratio \<1 favours AZD8931 40mg + paclitaxel|Originally, 166 patients were to be randomised to observe at least 133 progression events, based on HR=0.67, 80% power, 2-sided 5% significant level and a median of 6 months for the placebo arm. After 190 patients were randomised, the analysis was agreed to be performed at an similar level of maturity (70%) as originally planned (72%), after approximately 133 events.||2.01|0.67|0.607
72427968|NCT01649596|144367257|SUPERIORITY_OR_OTHER||percent|10.0||||0.12|TWO_SIDED||||||Chi-squared|||||||0.12
72427969|NCT01649596|144367258|SUPERIORITY_OR_OTHER||percent|48.0|||<|0.05|TWO_SIDED||||||t-test, 2 sided|A t-test for percents was used to compare the number of participants (%) from each group reporting satisfaction (somewhat and highly satisfied).||||||<0.05
72427970|NCT00883103|144367259|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||||||<0.001
72427971|NCT00962585|144367260|SUPERIORITY_OR_OTHER|||||||0.573||||||P-value was not adjusted for multiple comparisons and the a priori threshold for statistical significance was P \<0.05.|ANCOVA|"Model (Analysis of covariance): Week 4 = Baseline (MSVS) + Treatment + Site~Difference Between Means: S-equol treatment group - Placebo"||"\# of MSVS per week at each protocol visits = (# of Moderate+Severe hot flushes)/(Current protocol visit date-Previous protocol visit date (days)) x 7.~The ANCOVA procedure was used to test the following hypotheses:~H0: μ1 = μp versus HA: μ1 ≠ μp where μ1 and μp denote the mean frequency of MSVS (at Week 4 in case of primary efficacy endpoint), adjusted for Baseline MSVS values, in the treatment and placebo groups, respectively."||||0.5730
72427972|NCT00962585|144367260|SUPERIORITY_OR_OTHER||LS means difference|1.13|||>|0.05|TWO_SIDED|95.0|-10.06|12.32|||Pair-wise comparisons|||||12.32|-10.06|>0.05
72337954|NCT01340937|144199327|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 95% CI of the response rate difference is \>= -10%|Response Rate Difference (Comb - Ctrl)|-0.16|||<|0.001|TWO_SIDED|95.0|-2.41|3.22|||Miettinen and Nurminen|Response rate, response rate difference and p-value were stratified by brand of birth dose of Hepatitis B vaccine||||3.22|-2.41|<0.001
72427973|NCT00962585|144367260|SUPERIORITY_OR_OTHER||LS means difference|6.98|||>|0.05|TWO_SIDED|95.0|-3.87|17.84|||Pair-wise comparisons|||||17.84|-3.87|>0.05
72427974|NCT00962585|144367260|SUPERIORITY_OR_OTHER||LS means difference|0.94|||>|0.05|TWO_SIDED|95.0|-10.16|12.04|||Pair-wise comparisons|||||12.04|-10.16|>0.05
72427975|NCT00962585|144367261|SUPERIORITY_OR_OTHER|||||||0.7364||||||P-value was not adjusted for multiple comparisons and the a priori threshold for statistical significance was P \<0.05.|ANCOVA|"Model: Week 4 = Baseline (MSVS) + Treatment + Site~Difference Between Means: S-equol treatment group - Placebo"||"\# of MSVS per week at each protocol visits = (# of Moderate+Severe hot flushes)/(Current protocol visit date-Previous protocol visit date (days)) x 7~1-week period = remaining days of the period since the last visit (i.e. period following first 7 days, as per CRF)"||||0.7364
72427976|NCT00962585|144367261|SUPERIORITY_OR_OTHER||LS means difference|-0.19|||>|0.05|TWO_SIDED|95.0|-12.38|12.01|||Pair-wise comparisons|||||12.01|-12.38|>0.05
72427977|NCT00962585|144367261|SUPERIORITY_OR_OTHER||LS means difference|4.77|||>|0.05|TWO_SIDED|95.0|-6.94|16.48|||Pair-wise comparisons|||||16.48|-6.94|>0.05
72427978|NCT00962585|144367261|SUPERIORITY_OR_OTHER||LS means difference|-1.63|||>|0.05|TWO_SIDED|95.0|-13.41|10.15|||Pair-wise comparisons|||||10.15|-13.41|>0.05
72427979|NCT00962585|144367262|SUPERIORITY_OR_OTHER|||||||0.1217||||||P-value was not adjusted for multiple comparisons and the a priori threshold for statistical significance was P \<0.05. Treatment effect averaged across Weeks 1 and 2.|Repeated measures ANCOVA|"Mixed Model: MSVS = Baseline (MSVS) + Treatment + Site + Weeks + Treatment x Weeks~Difference Between Means: S-equol treatment group - Placebo"||\# of MSVS per week at each protocol visits = (# of Moderate+Severe hot flushes)/(Current protocol visit date-Previous protocol visit date (days)) x 7.||||0.1217
72427980|NCT00962585|144367262|SUPERIORITY_OR_OTHER||LS means difference|-3.77|||>|0.05||95.0|-12.69|5.16|||Pair-wise comparisons|||Week 1, Treatment Effect||5.16|-12.69|>0.05
72427981|NCT00962585|144367262|SUPERIORITY_OR_OTHER||LS means difference|9.69|||<|0.05|TWO_SIDED|95.0|0.79|18.6|||Pair-wise comparisons|||Week 1, Treatment Effect||18.60|0.79|<0.05
72427982|NCT00962585|144367262|SUPERIORITY_OR_OTHER||LS means difference|1.31|||>|0.05|TWO_SIDED|95.0|-7.73|10.36|||Pair-wise comparisons|||Week 1, Treatment Effect||10.36|-7.73|>0.05
72427983|NCT00962585|144367262|SUPERIORITY_OR_OTHER||LS means difference|-6.7|||>|0.05|TWO_SIDED|95.0|-18.36|4.96|||Pair-wise comparisons|||Week 2, Treatment Effect||4.96|-18.36|>0.05
72427984|NCT00962585|144367262|SUPERIORITY_OR_OTHER||LS means difference|3.56|||>|0.05|TWO_SIDED|95.0|-8.01|15.14|||Pair-wise comparisons|||Week 2, Treatment Effect||15.14|-8.01|>0.05
72427985|NCT00962585|144367262|SUPERIORITY_OR_OTHER||LS means difference|0.91|||>|0.05|TWO_SIDED|95.0|-10.77|12.58|||Pair-wise comparisons|||Week 2, Treatment Effect||12.58|-10.77|>0.05
72427986|NCT00962585|144367263|SUPERIORITY_OR_OTHER|||||||0.1609||||||P-value was not adjusted for multiple comparisons and the a priori threshold for statistical significance was P \<0.05. Treatment effect averaged across Weeks 1, 2 and 4.|Repeated measures ANCOVA|Mixed Model: Severity of VMS = Baseline (severity of VMS) + Treatment + Site + Weeks + Treatment x Weeks||Severity of VMS per week at each protocol visits = (Sum of scores of Mild, Moderate, Severe hot flushes)/(Current protocol visit date-Previous protocol visit date (days)) x 7, where severity of vasomotor symptoms are scored as: 1 = mild, 2 = moderate and 3 = severe.||||0.1609
72427987|NCT00962585|144367263|SUPERIORITY_OR_OTHER||LS means difference|-6.34|||>|0.05|TWO_SIDED|95.0|-26.41|13.73|||Pair-wise comparisons|||Week 1, Treatment Effect||13.73|-26.41|>0.05
72427988|NCT00962585|144367263|SUPERIORITY_OR_OTHER||LS means difference|25.67|||<|0.05|TWO_SIDED|95.0|5.64|45.69|||Pair-wise comparisons|||Week 1, Treatment Effect||45.69|5.64|<0.05
72427989|NCT00962585|144367263|SUPERIORITY_OR_OTHER||LS means difference|2.09|||>|0.05|TWO_SIDED|95.0|-18.21|22.39|||Pair-wise comparisons|||Week 1, Treatment Effect||22.39|-18.21|>0.05
72427990|NCT00962585|144367263|SUPERIORITY_OR_OTHER||LS means difference|-16.14|||>|0.05|TWO_SIDED|95.0|-43.29|11.01|||Pair-wise comparisons|||Week 2, Treatment Effect||11.01|-43.29|>0.05
72427991|NCT00962585|144367263|SUPERIORITY_OR_OTHER||LS means difference|8.73|||>|0.05|TWO_SIDED|95.0|-18.19|35.65|||Pair-wise comparisons|||Week 2, Treatment Effect||35.65|-18.19|>0.05
72427992|NCT00962585|144367263|SUPERIORITY_OR_OTHER||LS means difference|-0.65|||>|0.05|TWO_SIDED|95.0|-27.8|26.5|||Pair-wise comparisons|||Week 2, Treatment Effect||26.50|-27.80|>0.05
72427993|NCT00962585|144367263|SUPERIORITY_OR_OTHER||LS means difference|-1.69|||>|0.05|TWO_SIDED|95.0|-28.68|25.3|||Pair-wise comparisons|||Week 4, Treatment Effect||25.30|-28.68|>0.05
72427994|NCT00962585|144367263|SUPERIORITY_OR_OTHER||LS means difference|16.15|||>|0.05|TWO_SIDED|95.0|-10.4|42.71|||Pair-wise comparisons|||Week 4, Treatment Effect||42.71|-10.40|>0.05
72427995|NCT00962585|144367263|SUPERIORITY_OR_OTHER||LS means difference|-1.29|||>|0.05|TWO_SIDED|95.0|-28.18|25.6|||Pair-wise comparisons|||Week 4, Treatment Effect||25.60|-28.18|>0.05
72427996|NCT00962585|144367264|SUPERIORITY_OR_OTHER|||||||0.2211||||||P-value was not adjusted for multiple comparisons and the a priori threshold for statistical significance was P \<0.05. Treatment effect averaged across Weeks 2 and 4.|Repeated measures ANCOVA|Mixed Model: (Vaginal pH) = Baseline (Vaginal pH) + Treatment + Site + Weeks + Treatment x Weeks||||||0.2211
72427997|NCT00962585|144367264|SUPERIORITY_OR_OTHER||LS means difference|-0.21|||>|0.05|TWO_SIDED|95.0|-0.53|0.12|||Pair-wise comparisons|||Week 2, Treatment Effect||0.12|-0.53|>0.05
72427998|NCT00962585|144367264|SUPERIORITY_OR_OTHER||LS means difference|-0.23|||>|0.05|TWO_SIDED|95.0|-0.55|0.09|||Pair-wise comparisons|||Week 2, Treatment Effect||0.09|-0.55|>0.05
72427999|NCT00962585|144367264|SUPERIORITY_OR_OTHER||LS means difference|0.03|||>|0.05|TWO_SIDED|95.0|-0.28|0.35|||Pair-wise comparisons|||Week 2, Treatment Effect||0.35|-0.28|>0.05
72428000|NCT00962585|144367264|SUPERIORITY_OR_OTHER||LS means difference|-0.26|||>|0.05|TWO_SIDED|95.0|-0.54|0.02|||Pair-wise comparisons|||Week 4, Treatment Effect||0.02|-0.54|>0.05
72428001|NCT00962585|144367264|SUPERIORITY_OR_OTHER||LS means difference|-0.13|||>|0.05|TWO_SIDED|95.0|-0.4|0.14|||Pair-wise comparisons|||Week 4, Treatment Effect||0.14|-0.40|>0.05
72428002|NCT00962585|144367264|SUPERIORITY_OR_OTHER||LS means difference|-0.24|||>|0.05|TWO_SIDED|95.0|-0.51|0.03|||Pair-wise comparisons|||Week 4, Treatment Effect||0.03|-0.51|>0.05
72428003|NCT00962585|144367265|SUPERIORITY_OR_OTHER|||||||0.6375||||||P-value was not adjusted for multiple comparisons and the a priori threshold for statistical significance was P \<0.05. Treatment effect averaged across Weeks 2 and 4.|Repeated measures ANCOVA|Mixed Model: (Vaginal Maturation Index) = Baseline (Vaginal Maturation Index) + Treatment + Site + Weeks + Treatment x Weeks||Vaginal maturation index = 0.2 x (% parabasal cells) + 0.6 x(% intermediate cells) + 1.0 x (% superficial cells)||||0.6375
72428004|NCT00962585|144367265|SUPERIORITY_OR_OTHER||LS means difference|-1.58|||>|0.05|TWO_SIDED|95.0|-9.57|6.42|||Pair-wise comparisons|||Week 2, Treatment Effect||6.42|-9.57|>0.05
72428005|NCT00962585|144367265|SUPERIORITY_OR_OTHER||LS means difference|-1.58|||>|0.05|TWO_SIDED|95.0|-9.63|6.46|||Pair-wise comparisons|||Week 2, Treatment Effect||6.46|-9.63|>0.05
72428006|NCT00962585|144367265|SUPERIORITY_OR_OTHER||LS means difference|-1.59|||>|0.05|TWO_SIDED|95.0|-9.66|6.47|||Pair-wise comparisons|||Week 2, Treatment Effect||6.47|-9.66|>0.05
72428007|NCT00962585|144367265|SUPERIORITY_OR_OTHER||LS means difference|-0.31|||>|0.05|TWO_SIDED|95.0|-6.73|6.11|||Pair-wise comparisons|||Week 4, Treatment Effect||6.11|-6.73|>0.05
72428008|NCT00962585|144367265|SUPERIORITY_OR_OTHER||LS means difference|-6.14|||>|0.05|TWO_SIDED|95.0|-12.36|0.07|||Pair-wise comparisons|||Week 4, Treatment Effect||0.07|-12.36|>0.05
72428009|NCT00962585|144367265|SUPERIORITY_OR_OTHER||LS means difference|-2.88|||>|0.05|TWO_SIDED|95.0|-9.05|3.28|||Pair-wise comparisons|||Week 4, Treatment Effect||3.28|-9.05|>0.05
72428010|NCT00962585|144367266|SUPERIORITY_OR_OTHER|||||||0.0681||||||P-value is adjusted for multiple comparisons and the a priori threshold for statistical significance was P \<0.05. Treatment effect averaged across Weeks 2 and 4.|Repeated measures ANCOVA|Mixed Model: (Estradiol) = Baseline (Estradiol) + Treatment + Site + Weeks + Treatment x Weeks||||||0.0681
72428011|NCT00962585|144367266|SUPERIORITY_OR_OTHER||LS means difference|35.32|||>|0.05|TWO_SIDED|95.0|1.75|68.9|||Pair-wise comparisons|||Week 2, Treatment Effect||68.90|1.75|>0.05
72428012|NCT00962585|144367266|SUPERIORITY_OR_OTHER||LS means difference|3.61|||>|0.05|TWO_SIDED|95.0|-29.12|36.34|||Pair-wise comparisons|||Week 2, Treatment Effect||36.34|-29.12|>0.05
72337955|NCT01340937|144199328|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 95% CI of the response rate difference is \>= -10%|Response Rate Difference (Comb - Ctrl)|1.15|||<|0.001|TWO_SIDED|95.0|-2.13|5.47|||Miettinen and Nurminen|Response rate, response rate difference and p-value were stratified by brand of birth dose of Hepatitis B vaccine||||5.47|-2.13|<0.001
72428013|NCT00962585|144367266|SUPERIORITY_OR_OTHER||LS means difference|-4.58|||>|0.05|TWO_SIDED|95.0|-37.39|28.23|||Pair-wise comparisons|||Week 2, Treatment Effect||28.23|-37.39|>0.05
72428014|NCT00962585|144367266|SUPERIORITY_OR_OTHER||LS means difference|22.12|||>|0.05|TWO_SIDED|95.0|-23.56|67.8|||Pair-wise comparisons|||Week 4, Treatment Effect||67.80|-23.56|>0.05
72428015|NCT00962585|144367266|SUPERIORITY_OR_OTHER||LS means difference|7.8|||>|0.05|TWO_SIDED|95.0|-36.7|52.29|||Pair-wise comparisons|||Week 4, Treatment Effect||52.29|-36.70|>0.05
72428016|NCT00962585|144367266|SUPERIORITY_OR_OTHER||LS means difference|-22.74|||>|0.05|TWO_SIDED|95.0|-67.44|21.96|||Pair-wise comparisons|||Week 4, Treatment Effect||21.96|-67.44|>0.05
72428017|NCT00962585|144367270|SUPERIORITY_OR_OTHER|||||||0.0475||||||P-value was not adjusted for multiple comparisons and the a priori threshold for statistical significance was P \<0.05.|Wilcoxon (Mann-Whitney)|Wilcoxon Mann-Whitney test: S-equol treatment group versus Placebo: Percentage Change from Baseline at Week 4||||||0.0475
72428018|NCT00962585|144367270|SUPERIORITY_OR_OTHER|||||||0.0258||||||P-value was not adjusted for multiple comparisons and the a priori threshold for statistical significance P \<0.05.|Wilcoxon (Mann-Whitney)|Wilcoxon Mann-Whitney test: S-equol treatment group versus Placebo: Percentage Change from Baseline at Week 4||||||0.0258
72428019|NCT00962585|144367270|SUPERIORITY_OR_OTHER|||||||0.0281||||||P-value was not adjusted for multiple comparisons and the a priori threshold for statistical significance was P \<0.05.|Wilcoxon (Mann-Whitney)|Wilcoxon Mann-Whitney test: S-equol treatment group versus Placebo: Percentage Change from Baseline at Week 4||||||0.0281
72428020|NCT00962585|144367270|SUPERIORITY_OR_OTHER|||||||0.0645||95.0|||||Kruskal-Wallis|||All three S-equol treatment arms were aggregated and compared to placebo.||||0.0645
72428021|NCT00962585|144367271|SUPERIORITY_OR_OTHER|||||||0.0097||||||P-value is adjusted for multiple comparisons and the a priori threshold for statistical significance was P \<0.05.|Wilcoxon (Mann-Whitney)|Wilcoxon Mann-Whitney test: S-equol groups combined versus Placebo: Change from Baseline at Week 4||||||0.0097
72428022|NCT00962585|144367272|SUPERIORITY_OR_OTHER|||||||0.4352||||||P-value was not adjusted for multiple comparisons and the a priori threshold for statistical significance was P \<0.05.|Wilcoxon (Mann-Whitney)|Wilcoxon Mann-Whitney test: S-equol treatment group versus Placebo: Percentage Change from Baseline at Week 4||||||0.4352
72428023|NCT00962585|144367272|SUPERIORITY_OR_OTHER|||||||0.26||||||P-value was not adjusted for multiple comparisons and the a priori threshold for statistical significance was P \<0.05.|Wilcoxon (Mann-Whitney)|Wilcoxon Mann-Whitney test: S-equol treatment group versus Placebo: Percentage Change from Baseline at Week 4||||||0.2600
72428024|NCT00962585|144367272|SUPERIORITY_OR_OTHER|||||||0.7037||||||P-value was not adjusted for multiple comparisons and the a priori threshold for statistical significance was P \<0.05.|Wilcoxon (Mann-Whitney)|Wilcoxon Mann-Whitney test: S-equol treatment group versus Placebo: Percentage Change from Baseline at Week 4||||||0.7037
72428025|NCT00962585|144367272|SUPERIORITY_OR_OTHER|||||||0.7155|||||||Kruskal-Wallis|||All three S-equol treatment arms were aggregated and compared to placebo.||||0.7155
72428026|NCT00962585|144367273|SUPERIORITY_OR_OTHER|||||||0.0381||||||P-value is adjusted for multiple comparisons and the a priori threshold for statistical significance was P \<0.05.|Wilcoxon (Mann-Whitney)|Wilcoxon Mann-Whitney test: S-equol groups combined versus Placebo: Change from Baseline at Week 4||||||0.0381
72428027|NCT02254421|144367275|SUPERIORITY||Treatment difference|-0.02||||0.94|TWO_SIDED|95.0|-0.62|0.57||P-value was calculated from the ANCOVA model including baseline values and stratification factors.|ANCOVA|||||0.57|-0.62|0.94
72428028|NCT02254421|144367276|SUPERIORITY|||||||0.84||||||P-value was calculated from the negative binomial model with stratification factors as covariates.|Negative binomial|||||||0.84
72428029|NCT02254421|144367277|SUPERIORITY|||||||0.98||||||P-value was calculated from the Cochran-Mantel-Haenszel (CMH) test stratified by stratification factors.|Cochran-Mantel-Haenszel|||||||0.98
72428030|NCT02254421|144367278|SUPERIORITY|||||||0.19||||||P-value was calculated from the CMH test stratified by stratification factors.|Cochran-Mantel-Haenszel|||||||0.19
72428031|NCT01254565|144367323|SUPERIORITY|The primary endpoint was tested at the 0.05 level (1-sided).|LS Mean Difference|-76.9|||<|0.0001|TWO_SIDED|95.0|-86.9|-50.0|||ANOVA|A rank analysis of variance (ANOVA) model with treatment and screening PTH (\< 600 pg/mL or ≥ 600 pg/mL) as factors.||The hypothesis for this study (Cohorts 2 and 3) was that intravenous administration of etelcalcetide is superior to placebo for the reduction of PTH after TIW dosing in hemodialysis patients with secondary HPT. This hypothesis was tested in Cohorts 2 and 3 by comparing the mean percent changes from baseline in pre-hemodialysis PTH levels collected during the efficacy phase between the etelcalcetide and placebo groups within each cohort.||-50.0|-86.9|<0.0001
72428032|NCT01254565|144367323|SUPERIORITY|The primary endpoint was tested at the 0.05 level (1-sided).|LS Mean Difference|-36.7||||0.0032|TWO_SIDED|95.0|-59.8|-13.6|||ANOVA|ANOVA model with treatment and screening PTH (\< 600 pg/mL or ≥ 600 pg/mL) as factors.||The hypothesis for this study (Cohorts 2 and 3) was that intravenous administration of etelcalcetide is superior to placebo for the reduction of PTH after TIW dosing in hemodialysis patients with secondary HPT. This hypothesis was tested in Cohorts 2 and 3 by comparing the mean percent changes from baseline in pre-hemodialysis PTH levels collected during the efficacy phase between the etelcalcetide and placebo groups within each cohort.||-13.6|-59.8|0.0032
72428033|NCT01254565|144367324|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||||||<0.0001
72428034|NCT01254565|144367324|SUPERIORITY|||||||0.0968|||||||Fisher Exact|||||||0.0968
72428035|NCT01254565|144367325|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||||||<0.0001
72428036|NCT01254565|144367325|SUPERIORITY|||||||0.073|||||||Fisher Exact|||||||0.0730
72428037|NCT01254565|144367326|SUPERIORITY||LS Mean Difference|-11.3|||<|0.0001|TWO_SIDED|95.0|-16.4|-8.4|||ANOVA|A rank ANOVA model with treatment and screening PTH (\< 600 or ≥ 600 pg/mL) as factors.||||-8.4|-16.4|< 0.0001
72337956|NCT01340937|144199329|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 95% CI of the response rate difference is \>= -10%|Response Rate Difference (Comb - Ctrl)|3.0|||<|0.001|TWO_SIDED|95.0|-0.39|7.4|||Miettinen and Nurminen|Response rate, response rate difference and p-value were stratified by brand of birth dose of Hepatitis B vaccine||||7.40|-0.39|<0.001
72337957|NCT01340937|144199330|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 2-sided 95% CI of the GMC ratio is \>=0.67|GMC Ratio (Combined/Control)|0.92|||<|0.001|TWO_SIDED|95.0|0.82|1.04|||ANCOVA|GMC, GMC ratio, and p-value were adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine||Pneumococcal Serotype 1||1.04|0.82|<0.001
72337958|NCT01340937|144199330|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 2-sided 95% CI of the GMC ratio is \>=0.67|GMC Ratio (Combined/Control)|0.95|||<|0.001|TWO_SIDED|95.0|0.84|1.06|||ANCOVA|GMC, GMC ratio, and p-value were adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine||Pneumococcal Serotype 3||1.06|0.84|<0.001
72428038|NCT01254565|144367326|SUPERIORITY||LS Mean Difference|-6.9||||0.0235|TWO_SIDED|95.0|-12.8|-1.0|||ANOVA|ANOVA model with treatment and screening PTH (\< 600 or ≥ 600 pg/mL) as factors.||||-1.0|-12.8|0.0235
72428039|NCT01254565|144367327|SUPERIORITY||LS Mean Difference|-4.2||||0.2255|TWO_SIDED|95.0|-18.6|5.7|||ANOVA|A rank ANOVA model with treatment and screening PTH (\< 600 or ≥ 600 pg/mL) as factors.||||5.7|-18.6|0.2255
72337959|NCT01340937|144199330|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 2-sided 95% CI of the GMC ratio is \>=0.67|GMC Ratio (Combined/Control)|1.0|||<|0.001|TWO_SIDED|95.0|0.89|1.12|||ANCOVA|GMC, GMC ratio, and p-value were adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine||Pneumococcal Serotype 4||1.12|0.89|<0.001
72337960|NCT01340937|144199330|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 2-sided 95% CI of the GMC ratio is \>=0.67|GMC Ratio (Combined/Control)|0.93|||<|0.001|TWO_SIDED|95.0|0.8|1.07|||ANCOVA|GMC, GMC ratio, and p-value were adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine||Pneumococcal Serotype 5||1.07|0.80|<0.001
72428040|NCT01254565|144367327|SUPERIORITY||LS mean Difference|-21.8||||0.1751|TWO_SIDED|95.0|-29.8|5.9|||ANOVA|A rank ANOVA model with treatment and screening PTH (\< 600 or ≥ 600 pg/mL) as factors.||||5.9|-29.8|0.1751
72428041|NCT01254565|144367328|SUPERIORITY||LS Mean Difference|-11.2||||0.0112|TWO_SIDED|95.0|-26.8|-4.9|||ANOVA|A rank ANOVA model with treatment and screening PTH (\< 600 or ≥ 600 pg/mL) as factors.||||-4.9|-26.8|0.0112
72428042|NCT01254565|144367328|SUPERIORITY||LS Mean Difference|-27.7||||0.0554|TWO_SIDED|95.0|-39.3|-1.6|||ANOVA|A rank ANOVA model with treatment and screening PTH (\< 600 or ≥ 600 pg/mL) as factors.||||-1.6|-39.3|0.0554
72428043|NCT03354637|144367332|SUPERIORITY||Mean Difference (Final Values)|13.88|STANDARD_ERROR_OF_MEAN|4.707||0.038|TWO_SIDED|95.0|0.77|27.0||All statistical testing was two-sided and performed using a significance (alpha) level of 0.05.|Mixed Models Analysis|||Since this was the first multicenter study evaluating the effect of ATI-50002 Topical Solution in subjects with stable patchy alopecia areata, the sample size was based upon feasibility issues rather than a formal power calculation. Planned data from 120 subjects, utilizing LOCF for missing data, provides 80% power to detect a 24-point difference in percent change from baseline in SALT score between any two treatment groups. This power computation is based upon assumed standard deviation of 38%.||27.00|0.77|0.038
72428044|NCT03354637|144367332|SUPERIORITY||Mean Difference (Final Values)|9.32|STANDARD_ERROR_OF_MEAN|4.784||0.166|TWO_SIDED|95.0|-3.9|22.55||All statistical testing was two-sided and performed using a significance (alpha) level of 0.05.|Mixed Models Analysis|||Since this was the first multicenter study evaluating the effect of ATI-50002 Topical Solution in subjects with stable patchy alopecia areata, the sample size was based upon feasibility issues rather than a formal power calculation. Planned data from 120 subjects, utilizing LOCF for missing data, provides 80% power to detect a 24-point difference in percent change from baseline in SALT score between any two treatment groups. This power computation is based upon assumed standard deviation of 38%.||22.55|-3.90|0.166
72428045|NCT03354637|144367333|SUPERIORITY||Mean Difference (Final Values)|6.6|STANDARD_ERROR_OF_MEAN|4.511||0.302|TWO_SIDED|95.0|-5.97|19.17|||Mixed Models Analysis|||||19.17|-5.97|0.302
72428046|NCT03354637|144367333|SUPERIORITY||Mean Difference (Final Values)|3.23|STANDARD_ERROR_OF_MEAN|4.584||0.616|TWO_SIDED|95.0|-9.44|15.9|||Mixed Models Analysis|||||15.90|-9.44|0.616
72428047|NCT03354637|144367334|SUPERIORITY||Mean Difference (Final Values)|4.52|STANDARD_ERROR_OF_MEAN|2.074||0.125|TWO_SIDED|95.0|-1.26|10.3|||Mixed Models Analysis|||||10.30|-1.26|0.125
72337961|NCT01340937|144199330|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 2-sided 95% CI of the GMC ratio is \>=0.67|GMC Ratio (Combined/Control)|0.87|||<|0.001|TWO_SIDED|95.0|0.77|0.99|||ANCOVA|GMC, GMC ratio, and p-value were adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine||Pneumococcal Serotype 6A||0.99|0.77|<0.001
72337962|NCT01340937|144199330|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 2-sided 95% CI of the GMC ratio is \>=0.67|GMC Ratio (Combined/Control)|0.79||||0.055|TWO_SIDED|95.0|0.64|0.96|||ANCOVA|GMC, GMC ratio, and p-value were adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine||Pneumococcal Serotype 6B||0.96|0.64|0.055
72337963|NCT01340937|144199330|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 2-sided 95% CI of the GMC ratio is \>=0.67|GMC Ratio (Combined/Control)|0.89|||<|0.001|TWO_SIDED|95.0|0.8|0.99|||ANCOVA|GMC, GMC ratio, and p-value were adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine||Pneumococcal Serotype 7F||0.99|0.80|<0.001
72337964|NCT01340937|144199330|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 2-sided 95% CI of the GMC ratio is \>=0.67|GMC Ratio (Combined/Control)|1.0|||<|0.001|TWO_SIDED|95.0|0.88|1.13|||ANCOVA|GMC, GMC ratio, and p-value were adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine||Pneumococcal Serotype 9V||1.13|0.88|<0.001
72337965|NCT01340937|144199330|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 2-sided 95% CI of the GMC ratio is \>=0.67|GMC Ratio (Combined/Control)|0.95|||<|0.001|TWO_SIDED|95.0|0.82|1.1|||ANCOVA|GMC, GMC ratio, and p-value were adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine||Pneumococcal Serotype 14||1.10|0.82|<0.001
72337966|NCT01340937|144199330|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 2-sided 95% CI of the GMC ratio is \>=0.67|GMC Ratio (Combined/Control)|0.89|||<|0.001|TWO_SIDED|95.0|0.79|1.0|||ANCOVA|GMC, GMC ratio, and p-value were adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine||Pneumococcal Serotype 18C||1.00|0.79|<0.001
72337967|NCT01340937|144199330|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 2-sided 95% CI of the GMC ratio is \>=0.67|GMC Ratio (Combined/Control)|0.91|||<|0.001|TWO_SIDED|95.0|0.8|1.03|||ANCOVA|GMC, GMC ratio, and p-value were adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine||Pneumococcal Serotype 19A||1.03|0.80|<0.001
72337968|NCT01340937|144199330|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 2-sided 95% CI of the GMC ratio is \>=0.67|GMC Ratio (Combined/Control)|0.97|||<|0.001|TWO_SIDED|95.0|0.87|1.08|||ANCOVA|GMC, GMC ratio, and p-value were adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine||Pneumococcal Serotype 19F||1.08|0.87|<0.001
72337969|NCT01340937|144199330|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 2-sided 95% CI of the GMC ratio is \>=0.67|GMC Ratio (Combined/Control)|0.9|||<|0.001|TWO_SIDED|95.0|0.77|1.06|||ANCOVA|GMC, GMC ratio, and p-value were adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine||Pneumococcal Serotype 23F||1.06|0.77|<0.001
72337970|NCT01340937|144199332|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.7|||||TWO_SIDED|95.0|-18.8|-8.4|||||Mean Difference is V419 - Control. The 95% confidence interval is based on the unstratified Miettinen and Nurminen method.|Estimated Difference, all routes \<38.0°C||-8.4|-18.8|
72337971|NCT01340937|144199332|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.9|||||TWO_SIDED|95.0|-0.9|8.3|||||Mean Difference is V419 - Control. The 95% confidence interval is based on the unstratified Miettinen and Nurminen method.|Estimated Difference, all routes \>=38°C and \<38.5°||8.3|-0.9|
72337972|NCT01340937|144199332|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.7|||||TWO_SIDED|95.0|4.8|11.9|||||Mean Difference is V419 - Control. The 95% confidence interval is based on the unstratified Miettinen and Nurminen method.|Estimated Difference, all routes \>=38.5°C and \<39.5°||11.9|4.8|
72337973|NCT01340937|144199332|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.1|||||TWO_SIDED|95.0|-0.7|2.2|||||Mean Difference is V419 - Control. The 95% confidence interval is based on the unstratified Miettinen and Nurminen method.|Estimated Difference, all routes \>=39.5°C||2.2|-0.7|
72337974|NCT01340937|144199332|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.3|||||TWO_SIDED|95.0|-16.6|-5.9|||||Mean Difference is V419 - Control. The 95% confidence interval is based on the unstratified Miettinen and Nurminen method.|Estimated Difference; rectal \<38.0°C||-5.9|-16.6|
72337975|NCT01340937|144199332|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.5|||||TWO_SIDED|95.0|-1.4|7.8|||||Mean Difference is V419 - Control. The 95% confidence interval is based on the unstratified Miettinen and Nurminen method.|Estimated Difference; rectal \>=38.0°C and \<38.5°C||7.8|-1.4|
72337976|NCT01340937|144199332|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.4|||||TWO_SIDED|95.0|4.6|11.6|||||Mean Difference is V419 - Control. The 95% confidence interval is based on the unstratified Miettinen and Nurminen method.|Estimated Difference, rectal \>=38.5°C and \<39.5°C||11.6|4.6|
72337977|NCT01340937|144199332|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.1|||||TWO_SIDED|95.0|-0.7|2.1|||||Mean Difference is V419 - Control. The 95% confidence interval is based on the unstratified Miettinen and Nurminen method.|Estimated Difference, rectal \>=39.5°C||2.1|-0.7|
72337978|NCT00623545|144199352|SUPERIORITY_OR_OTHER||Mean Difference (Net)|185.0|STANDARD_DEVIATION|240.0||0.001|TWO_SIDED|95.0||||The a prior threshold for statistical significance was p\< 0.05|ANOVA||units are kcal/d|Previously published literature showed an average weight loss of 1.8 kg at 12 weeks of exenatide treatment. This was converted to differ- ence in TEE, estimating an average imbalance of 2 kg × 7800 kcal·kg-1 divided by 84 days or 185 kcal·day-1.We demonstrated an average reproducibility of the DLW method of 6% or 240 kcal·day-1. For a 5% probability of finding this difference with a power of 80%, we determined a need for 14 subjects to complete the study.||||0.001
72337979|NCT00623545|144199352|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|||<|0.05|TWO_SIDED||||||t-test, 2 sided|||||||<0.05
72337980|NCT00623545|144199353|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||t-test, 2 sided|||The null hypothesis was that energy intake was unchanged between the period before treatment and at the end of treatment.||||< 0.05
72337981|NCT00623545|144199353|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|||<|0.05|TWO_SIDED||||||t-test, 2 sided|||||||<0.05
72337982|NCT01035346|144199354|SUPERIORITY_OR_OTHER||Least-squares (LS) mean difference|8.33||||0.228|TWO_SIDED|95.0|-7.94|24.6||p-value was calculated using ANOVA model with treatment and baseline temperature terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||Treatment difference (Ibuprofen sodium-Placebo) and corresponding 95 percent (%) confidence interval (CI) were calculated based on Least-squares (LS) means from the Analysis of Variance (ANOVA) model.||24.60|-7.94|0.228
72337983|NCT01035346|144199355|SUPERIORITY_OR_OTHER||LS mean difference|5.99||||0.171|TWO_SIDED|95.0|-3.99|15.97||p-value was calculated using ANOVA model with treatment and baseline temperature terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||STEMPD 0-4: Treatment difference (Ibuprofen sodium-Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||15.97|-3.99|0.171
72337984|NCT01035346|144199355|SUPERIORITY_OR_OTHER||LS mean difference|8.96||||0.354|TWO_SIDED|95.0|-14.78|32.69||p-value was calculated using ANOVA model with treatment and baseline temperature terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||STEMPD 0-8: Treatment difference (Ibuprofen sodium-Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||32.69|-14.78|0.354
72337985|NCT01035346|144199356|SUPERIORITY_OR_OTHER||LS mean difference|-0.15||||0.576|TWO_SIDED|95.0|-0.84|0.54||p-value was calculated using ANOVA model with treatment and baseline temperature terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||0.25 hours: Treatment difference (Ibuprofen sodium-Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.54|-0.84|0.576
72337986|NCT01035346|144199356|SUPERIORITY_OR_OTHER||LS mean difference|0.18||||0.502|TWO_SIDED|95.0|-0.5|0.87||p-value was calculated using ANOVA model with treatment and baseline temperature terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||0.5 hours: Treatment difference (Ibuprofen sodium-Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.87|-0.50|0.502
72337987|NCT01035346|144199356|SUPERIORITY_OR_OTHER||LS mean difference|1.31||||0.116|TWO_SIDED|95.0|-0.51|3.12||p-value was calculated using ANOVA model with treatment and baseline temperature terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1 hour: Treatment difference (Ibuprofen sodium-Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||3.12|-0.51|0.116
72337988|NCT01035346|144199356|SUPERIORITY_OR_OTHER||LS mean difference|1.58||||0.161|TWO_SIDED|95.0|-0.98|4.14||p-value was calculated using ANOVA model with treatment and baseline temperature terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||2 hours: Treatment difference (Ibuprofen sodium-Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||4.14|-0.98|0.161
72337989|NCT01035346|144199356|SUPERIORITY_OR_OTHER||LS mean difference|1.87||||0.215|TWO_SIDED|95.0|-1.66|5.41||p-value was calculated using ANOVA model with treatment and baseline temperature terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||4 hours: Treatment difference (Ibuprofen sodium-Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||5.41|-1.66|0.215
72337990|NCT01035346|144199356|SUPERIORITY_OR_OTHER||LS mean difference|1.17||||0.388|TWO_SIDED|95.0|-2.18|4.52||p-value was calculated using ANOVA model with treatment and baseline temperature terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||6 hours: Treatment difference (Ibuprofen sodium-Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||4.52|-2.18|0.388
72337991|NCT01035346|144199356|SUPERIORITY_OR_OTHER||LS mean difference|0.31||||0.849|TWO_SIDED|95.0|-3.98|4.61||p-value was calculated using ANOVA model with treatment and baseline temperature terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||8 hours: Treatment difference (Ibuprofen sodium-Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||4.61|-3.98|0.849
72428048|NCT03354637|144367334|SUPERIORITY||Mean Difference (Final Values)|3.53|STANDARD_ERROR_OF_MEAN|2.107||0.234|TWO_SIDED|95.0|-2.3|9.36|||Mixed Models Analysis|||||9.36|-2.30|0.234
72337992|NCT01035346|144199358|SUPERIORITY_OR_OTHER||difference in proportion|11.11||||0.378|TWO_SIDED|95.0|-10.67|32.89||p-value was calculated using CMH general association test using table scores. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||8 hours: Treatment difference (Ibuprofen sodium-Placebo) and its associated CI were calculated based on Cochran-Mantel-Haenszel (CMH) adjusted proportion and the corresponding standard errors.||32.89|-10.67|0.378
72337993|NCT01035346|144199359|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.48||||0.324|TWO_SIDED|95.0|-0.3|1.27||p-value was calculated using CMH test with modified ridit scores. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||Treatment difference (Ibuprofen sodium-Placebo) and the associated CI were calculated based on the weighted Gamma statistic.||1.27|-0.30|0.324
72337994|NCT01035346|144199360|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.53||||0.21|TWO_SIDED|95.0|-0.12|1.18||p-value was calculated using CMH test with modified ridit scores. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||Treatment difference (Ibuprofen sodium-Placebo) and the associated CI were calculated based on the weighted Gamma statistic.||1.18|-0.12|0.210
72337995|NCT01974752|144199361|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.78||||0.3195|TWO_SIDED|95.0|0.48|1.27|||Log Rank|Factor for treatment and liver metastases|A hazard ratio \< 1 favours Selumetinib in combination with Dacarbazine|||1.27|0.48|0.3195
72337996|NCT01974752|144199363|SUPERIORITY_OR_OTHER||Geometric LS mean ratio|0.94||||0.1284|TWO_SIDED|95.0|0.88|1.02|||ANCOVA|ANCOVA of log (W6/BL) tumour assessments with a factor for trt, and covariates for liver mets, log BL tumour size, and time from BL scan to rand.|A geometric least squares mean ratio \< 1 favours Selumetinib in combination with Dacarbazine|||1.02|0.88|0.1284
72337997|NCT01974752|144199364|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.75||||0.4011|TWO_SIDED|95.0|0.39|1.46|||Log Rank|||||1.46|0.39|0.4011
72428049|NCT03354637|144367335|SUPERIORITY||Mean Difference (Final Values)|1.55|STANDARD_ERROR_OF_MEAN|2.131||0.607|TWO_SIDED|95.0|-4.39|7.49|||Mixed Models Analysis|||||7.49|-4.39|0.607
72428050|NCT03354637|144367335|SUPERIORITY||Mean Difference (Final Values)|-0.07|STANDARD_ERROR_OF_MEAN|2.165||0.981|TWO_SIDED|95.0|-6.06|5.92|||Mixed Models Analysis|||||5.92|-6.06|0.981
72428051|NCT03354637|144367336|SUPERIORITY||Odds Ratio (OR)|1.4||||0.62|TWO_SIDED|95.0|0.4|4.6|||Mixed Models Analysis|||||4.6|0.4|0.620
72428052|NCT03354637|144367336|SUPERIORITY||Odds Ratio (OR)|1.7||||0.366|TWO_SIDED|95.0|0.5|5.8|||Mixed Models Analysis|||||5.8|0.5|0.366
72337998|NCT05074888|144199385|SUPERIORITY|||||||0.0016|||||||Wilcoxon (Mann-Whitney)|||This analysis applies to ∆ between baseline and 4 weeks later row.||||0.0016
72337999|NCT05074888|144199386|SUPERIORITY|||||||0.3183|||||||Wilcoxon (Mann-Whitney)|||This analysis applies to ∆ between baseline and 4 weeks later row.||||0.3183
72338000|NCT05074888|144199387|SUPERIORITY|||||||0.5805|||||||Wilcoxon (Mann-Whitney)|||This analysis applies to ∆ between baseline and 4 weeks later row.||||0.5805
72338001|NCT05074888|144199388|SUPERIORITY|||||||0.2143|||||||Wilcoxon (Mann-Whitney)|||This analysis applies to ∆ between baseline and 4 weeks later row.||||0.2143
72338002|NCT05074888|144199389|SUPERIORITY|||||||0.8156|||||||Wilcoxon (Mann-Whitney)|||This analysis applies to ∆ between value after 4 weeks and after 8 weeks row.||||0.8156
72338003|NCT05074888|144199390|SUPERIORITY|||||||0.1049|||||||Wilcoxon (Mann-Whitney)|||This analysis applies to ∆ between value after 4 weeks and after 8 weeks row.||||0.1049
72338004|NCT05074888|144199391|SUPERIORITY|||||||0.726|||||||Wilcoxon (Mann-Whitney)|||This analysis applies to ∆ between value after 4 weeks and after 8 weeks row.||||0.7260
72338005|NCT05074888|144199392|SUPERIORITY|||||||0.6808|||||||Wilcoxon (Mann-Whitney)|||This analysis applies to ∆ between value after 4 weeks and after 8 weeks row.||||0.6808
72338006|NCT05074888|144199393|SUPERIORITY|||||||0.54||||||"The p-value associated with treatment\*visit interaction of pulse rate (heart rate) from Visit 1 to 3 between Prospekta and Placebo treatment groups. Model includes treatment, visit and treatment\*visit interaction."|Mixed Models Analysis|||||||0.54
72338007|NCT05074888|144199394|SUPERIORITY|||||||0.49||||||"The p-value associated with treatment\*visit interaction of respiration rate (breathing rate) from Visit 1 to 3 between Prospekta and Placebo treatment groups. Model includes treatment, visit and treatment\*visit interaction."|Mixed Models Analysis|||||||0.49
72428053|NCT03354637|144367337|SUPERIORITY||Odds Ratio (OR)|0.1||||0.157|TWO_SIDED|95.0|0.0|2.3|||Mixed Models Analysis|||||2.3|0.0|0.157
72338008|NCT05074888|144199395|SUPERIORITY|||||||0.87||||||"The p-value associated with treatment\*visit interaction of systolic blood pressure from Visit 1 to 3 between Prospekta and Placebo treatment groups. Model includes treatment, visit and treatment\*visit interaction."|Mixed Models Analysis|||This analysis applies to SBP/Visit1, SBP/Visit2 and SBP/Visit3 rows.||||0.87
72338009|NCT05074888|144199395|SUPERIORITY|||||||0.22||||||"The p-value associated with treatment\*visit interaction of diastolic blood pressure from Visit 1 to 3 between Prospekta and Placebo treatment groups. Model includes treatment, visit and treatment\*visit interaction."|Mixed Models Analysis|||This analysis applies to DBP/Visit1, DBP/Visit2 and DBP/Visit3 rows.||||0.22
72338010|NCT05074888|144199396|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.0
72338011|NCT05074888|144199397|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.0
72338012|NCT05074888|144199398|SUPERIORITY|||||||0.17|||||||Fisher Exact|||||||0.17
72338013|NCT05074888|144199399|SUPERIORITY|||||||0.004|||||||Fisher Exact|||||||0.004
72338014|NCT03541187|144199409|SUPERIORITY|The comparison between arms will be conducted using an analysis of covariance (ANCOVA) model, in which the change from the baseline to the 12-month TNSS mean serves as the outcome. The ANCOVA model will incorporate factors for treatment while adjusting for both the baseline TNSS mean and site.|Least Square Mean Difference|-0.23||||0.63|TWO_SIDED|95.0|-1.15|0.7|||ANCOVA|||||0.70|-1.15|0.63
72338015|NCT03541187|144199411|SUPERIORITY||Least Square Means Difference|-0.17||||0.69|TWO_SIDED|95.0|-0.99|0.66|||ANCOVA|||||0.66|-0.99|0.69
72338016|NCT03541187|144199412|SUPERIORITY||Hazard Ratio (HR)|0.81||||0.51|TWO_SIDED|95.0|0.42|1.54|||Regression, Cox||At the reactive dose of 15.4 mcg/mL after 12 months, there were 11 participants who were right-censored in the Cockroach SCIT arm and 8 participants who were right-censored in the Placebo arm.|||1.54|0.42|.51
72338017|NCT03541187|144199413|SUPERIORITY||Least Square Means Difference|-0.03||||0.91|TWO_SIDED|95.0|-0.54|0.49|||ANCOVA|||||0.49|-0.54|0.91
72338018|NCT03541187|144199414|SUPERIORITY||Least Square Means Difference|5.32|||<|0.001|TWO_SIDED|95.0|4.77|5.87|||ANCOVA|||||5.87|4.77|<0.001
72338019|NCT00904618|144199452|SUPERIORITY_OR_OTHER|||||||0.0087||95.0|||||Fisher Exact|||The test applies to the number of participants improved.||||0.0087
72428054|NCT03354637|144367337|SUPERIORITY||Odds Ratio (OR)|0.4||||0.353|TWO_SIDED|95.0|0.1|2.8|||Mixed Models Analysis|||||2.8|0.1|0.353
72338020|NCT03220581|144199455|SUPERIORITY||F|9.026||||0.004|TWO_SIDED||||||ANCOVA|Baseline number of days of game play in the past week was included as a covariate.||||||.004
72338021|NCT03220581|144199456|SUPERIORITY||F|7.922||||0.007|TWO_SIDED||||||ANCOVA|Covariate = number of days of gaming in the past week at baseline, reported by the parent.||||||.007
72338022|NCT03220581|144199457|SUPERIORITY||F|3.73||||0.059|TWO_SIDED||||||ANCOVA|Controlled for number of symptoms of Internet gaming disorder at baseline - assessed through clinical interview with child||||||.059
72338023|NCT03220581|144199458|SUPERIORITY||F|2.91||||0.095|TWO_SIDED||||||ANCOVA|Controlled for baseline number of symptoms of Internet gaming disorder, assessed through clinical interview with the parent||||||.095
72338024|NCT02266277|144199460|SUPERIORITY|"We calculated frequencies and performed intention-to-treat bivariate analyses. We then performed multivariate logistic regression analyses.~With our proposed sample size and using a factorial design, power calculations based on estimates of baseline vaccination rates indicated that 4286 participants per arm would give 80% power to detect a 3% improvement in influenza vaccination rates between groups (α=.05; 2-sided)."|Odds Ratio (OR)|1.3||||0.0001|TWO_SIDED|95.0|1.15|1.47||Adjusted for age, sex, race and utilization|Regression, Logistic|||||1.47|1.15|0.0001
72338025|NCT02266277|144199460|SUPERIORITY|"We calculated frequencies and performed intention-to-treat bivariate analyses. We then performed multivariate logistic regression analyses.~With our proposed sample size and using a factorial design, power calculations based on estimates of baseline vaccination rates indicated that 4286 participants per arm would give 80% power to detect a 3% improvement in influenza vaccination rates between groups (α=.05; 2-sided)."|Odds Ratio (OR)|1.2||||0.0026|TWO_SIDED|95.0|1.07|1.36|||Regression, Logistic|||||1.36|1.07|.0026
72428055|NCT03354637|144367338|SUPERIORITY||Odds Ratio (OR)|1.7||||0.333|TWO_SIDED|95.0|0.6|5.4|||Mixed Models Analysis|||||5.4|0.6|0.333
72428056|NCT03354637|144367338|SUPERIORITY||Odds Ratio (OR)|1.7||||0.388|TWO_SIDED|95.0|0.5|5.2|||Mixed Models Analysis|||||5.2|0.5|0.388
72428057|NCT03354637|144367339|SUPERIORITY||Odds Ratio (OR)|0.7||||0.435|TWO_SIDED|95.0|0.3|1.8|||Mixed Models Analysis|||||1.8|0.3|0.435
72428058|NCT03354637|144367339|SUPERIORITY||Odds Ratio (OR)|0.6||||0.37|TWO_SIDED|95.0|0.2|1.7|||Mixed Models Analysis|||||1.7|0.2|0.370
72338026|NCT02266277|144199460|SUPERIORITY|"We calculated frequencies and performed intention-to-treat bivariate analyses. We then performed multivariate logistic regression analyses.~With our proposed sample size and using a factorial design, power calculations based on estimates of baseline vaccination rates indicated that 4286 participants per arm would give 80% power to detect a 3% improvement in influenza vaccination rates between groups (α=.05; 2-sided)."|Odds Ratio (OR)|1.16||||0.0206|TWO_SIDED|95.0|1.02|1.31|||Regression, Logistic|||||1.31|1.02|.0206
72338027|NCT02266277|144199460|SUPERIORITY|"We calculated frequencies and performed intention-to-treat bivariate analyses. We then performed multivariate logistic regression analyses.~With our proposed sample size and using a factorial design, power calculations based on estimates of baseline vaccination rates indicated that 4286 participants per arm would give 80% power to detect a 3% improvement in influenza vaccination rates between groups (α=.05; 2-sided)."|Odds Ratio (OR)|1.07||||0.233|TWO_SIDED|95.0|0.96|1.21|||Regression, Logistic|||||1.21|.96|.2330
72338028|NCT02266277|144199460|SUPERIORITY|"We calculated frequencies and performed intention-to-treat bivariate analyses. We then performed multivariate logistic regression analyses.~With our proposed sample size and using a factorial design, power calculations based on estimates of baseline vaccination rates indicated that 4286 participants per arm would give 80% power to detect a 3% improvement in influenza vaccination rates between groups (α=.05; 2-sided)."|Odds Ratio, log|1.12||||0.0579|TWO_SIDED|95.0|0.996|1.26|||Regression, Logistic|||||1.26|.996|.0579
72338029|NCT02266277|144199460|SUPERIORITY|"We calculated frequencies and performed intention-to-treat bivariate analyses. We then performed multivariate logistic regression analyses.~With our proposed sample size and using a factorial design, power calculations based on estimates of baseline vaccination rates indicated that 4286 participants per arm would give 80% power to detect a 3% improvement in influenza vaccination rates between groups (α=.05; 2-sided)."|Odds Ratio (OR)|0.99||||0.87|TWO_SIDED|95.0|0.86|1.14|||Regression, Logistic|||||1.14|.86|.87
72338030|NCT02266277|144199461|SUPERIORITY|Using as a denominator those patients identified as being overdue for pneumococcal vaccine at the time of randomization, we calculated frequencies and performed bivariate and multivariate logistic regression analyses, examining the association between randomization group and completion of pneumococcal vaccine. We analyzed portal users and non-portal users separately.|Odds Ratio (OR)|1.03||||0.82|TWO_SIDED|95.0|0.81|1.31|||Regression, Logistic|||||1.31|.81|.82
72338031|NCT02266277|144199461|SUPERIORITY|Using as a denominator those patients identified as being overdue for pneumococcal vaccine at the time of randomization, we calculated frequencies and performed bivariate and multivariate logistic regression analyses, examining the association between randomization group and completion of pneumococcal vaccine. We analyzed portal users and non-portal users separately.|Odds Ratio, log|0.9||||0.36|TWO_SIDED|95.0|0.71|1.13|||Regression, Logistic|||||1.13|.71|.36
72338032|NCT02266277|144199461|SUPERIORITY|Using as a denominator those patients identified as being overdue for pneumococcal vaccine at the time of randomization, we calculated frequencies and performed bivariate and multivariate logistic regression analyses, examining the association between randomization group and completion of pneumococcal vaccine. We analyzed portal users and non-portal users separately.|Odds Ratio (OR)|0.89||||0.33|TWO_SIDED|95.0|0.71|1.13|||Regression, Logistic|||||1.13|.71|.33
72338033|NCT02266277|144199461|SUPERIORITY|Using as a denominator those patients identified as being overdue for pneumococcal vaccine at the time of randomization, we calculated frequencies and performed bivariate and multivariate logistic regression analyses, examining the association between randomization group and completion of pneumococcal vaccine. We analyzed portal users and non-portal users separately.|Odds Ratio (OR)|0.87||||0.23|TWO_SIDED|95.0|0.69|1.09|||Regression, Logistic|||||1.09|.69|.23
72338034|NCT02266277|144199461|SUPERIORITY|Using as a denominator those patients identified as being overdue for pneumococcal vaccine at the time of randomization, we calculated frequencies and performed bivariate and multivariate logistic regression analyses, examining the association between randomization group and completion of pneumococcal vaccine. We analyzed portal users and non-portal users separately.|Odds Ratio (OR)|0.99||||0.96|TWO_SIDED|95.0|0.79|1.25|||Regression, Logistic|||||1.25|.79|.96
72338035|NCT02266277|144199461|SUPERIORITY|Using as a denominator those patients identified as being overdue for pneumococcal vaccine at the time of randomization, we calculated frequencies and performed bivariate and multivariate logistic regression analyses, examining the association between randomization group and completion of pneumococcal vaccine. We analyzed portal users and non-portal users separately.|Odds Ratio (OR)|1.04||||0.76|TWO_SIDED|95.0|0.82|1.31|||Regression, Logistic|||||1.31|.82|.76
72338036|NCT00747344|144199488|SUPERIORITY_OR_OTHER||||||<|0.001||||||The study was designed to maintain a Type I error of 0.05 or less for the primary analysis.|Cochran-Mantel-Haenszel|Stratified by baseline weight (≤ 65 kg vs \> 65 kg).||Null Hypothesis: No difference between ustekinumab 45 mg and placebo for the primary endpoint at a significance level of 0.05. With 120 subjects (60 in each treatment group), simulation studies were conducted to calculate the power to detect a treatment difference in the primary endpoint between ustekinumab 45 mg group and placebo using a CMH test stratified by baseline weight (\<=65kg vs \> 65 kg). For all the scenarios evaluated, the power was \> 99% at a significance level of 0.05.||||<0.001
72338037|NCT00747344|144199489|SUPERIORITY_OR_OTHER||||||<|0.001||||||No multiplicity adjustment was made and nominal p-value was reported.|Cochran-Mantel-Haenszel|Stratified by baseline weight (≤ 65 kg vs \> 65 kg).||Null Hypothesis: No difference between ustekinumab 45 mg and placebo at a significance level of 0.05.||||<0.001
72428059|NCT03354637|144367340|SUPERIORITY||Odds Ratio (OR)|1.7||||0.333|TWO_SIDED|95.0|0.6|5.4|||Mixed Models Analysis|||||5.4|0.6|0.333
72428060|NCT03354637|144367340|SUPERIORITY||Odds Ratio (OR)|1.7||||0.388|TWO_SIDED|95.0|0.5|5.2|||Mixed Models Analysis|||||5.2|0.5|0.388
72428061|NCT03354637|144367341|SUPERIORITY|||||||0.505|||||||Wilcoxon (Mann-Whitney)|||||||0.505
72428062|NCT03354637|144367341|SUPERIORITY|||||||0.359|||||||Wilcoxon (Mann-Whitney)|||||||0.359
72428063|NCT03354637|144367342|SUPERIORITY|||||||0.602|||||||Wilcoxon (Mann-Whitney)|||||||0.602
72428064|NCT03354637|144367342|SUPERIORITY|||||||0.643|||||||Wilcoxon (Mann-Whitney)|||||||0.643
72428065|NCT03354637|144367343|SUPERIORITY|||||||0.992|||||||Wilcoxon (Mann-Whitney)|||||||0.992
72428066|NCT03354637|144367343|SUPERIORITY|||||||0.257|||||||Wilcoxon (Mann-Whitney)|||||||0.257
72428067|NCT03354637|144367345|SUPERIORITY|||||||0.374|||||||Wilcoxon (Mann-Whitney)|||||||0.374
72428068|NCT03354637|144367345|SUPERIORITY|||||||0.253|||||||Wilcoxon (Mann-Whitney)|||||||0.253
72428069|NCT03354637|144367347|SUPERIORITY|||||||0.102|||||||Wilcoxon (Mann-Whitney)|||||||0.102
72338038|NCT00747344|144199490|SUPERIORITY_OR_OTHER||||||<|0.001||||||No multiplicity adjustment was made and nominal p-value was reported.|ANOVA|Analysis of variance on van der Waerden normal scores (Conover, 1980) with treatment and baseline weight (≤ 65kg vs \> 65 kg) as factors in the model.||Null Hypothesis: No difference between ustekinumab 45 mg and placebo at a significance level of 0.05.||||<0.001
72338039|NCT00765882|144199491|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.93||||0.0012|TWO_SIDED|95.0|1.5|5.72||The p-value is still less than 0.05 after adjusting multiplicity using a serial gatekeeping multiple comparison procedure.|Cochran-Mantel-Haenszel|||"Null hypothesis: There is no difference in the proportion of 12-week CSBM overall responders between patients taking the 145-μg dose and those taking placebo.~The power, adjusted for multiplicity, was expected to be 90% based on study NCT00402337 (MCP-103-201) data."||5.72|1.50|0.0012
72338040|NCT00765882|144199491|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.22|||<|0.0001|TWO_SIDED|95.0|2.2|8.1||The p-value is still less than 0.05 after adjusting multiplicity using a serial gatekeeping multiple comparison procedure.|Cochran-Mantel-Haenszel|||"Null hypothesis: There is no difference in the proportion of 12-week CSBM overall responders between patients taking the 290-μg dose and those taking placebo.~The power, adjusted for multiplicity, was expected to be 96% based on study NCT00460811 (MCP-103-202) data."||8.10|2.20|<0.0001
72338041|NCT01945775|144199589|SUPERIORITY||Hazard Ratio, log|0.542|||<|0.0001|TWO_SIDED|95.0|0.413|0.711|||Log Rank|||Hazard ratio was based on stratified Cox regression model with treatment as the only covariate (stratification factors: number of prior cytotoxic chemotherapy regimens, triple negative status, history of central nervous system metastasis status).||0.711|0.413|<0.0001
72338042|NCT01945775|144199590|SUPERIORITY||Odds Ratio (OR)|4.99|||<|0.0001|TWO_SIDED|95.0|2.93|8.83|||Cochran-Mantel-Haenszel|||p-value was based on stratified Cochran-Mantel-Haenszel method. Stratification factors: number of prior cytotoxic chemotherapy regimens, triple negative status, history of central nervous system metastasis status.||8.83|2.93|<0.0001
72338043|NCT01945775|144199591|SUPERIORITY||Hazard Ratio (HR)|0.848||||0.1693|TWO_SIDED|95.0|0.67|1.073|||Log Rank|||Hazard ratio was based on stratified Cox regression model with treatment as the only covariate (stratification factors: number of prior cytotoxic chemotherapy regimens, triple negative status, history of central nervous system metastasis status).||1.073|0.670|0.1693
72338044|NCT01945775|144199599|SUPERIORITY||Mean Difference (Final Values)|8.4|||<|0.0001|TWO_SIDED|95.0|4.6|12.3|||Mixed Models Analysis|||Analysis was based on repeated measures mixed-effect model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate. Analysis was based on restricted maximum likelihood using unstructured covariance matrix.||12.3|4.6|<0.0001
72338045|NCT01945775|144199600|SUPERIORITY||Hazard Ratio (HR)|0.376|||<|0.0001|TWO_SIDED|95.0|0.257|0.549|||Log Rank|||Hazard ratio is based on stratified Cox regression model with treatment as the only covariate (stratification factors: number of prior cytotoxic chemotherapy regimens, triple negative status, history of central nervous system metastasis status).||0.549|0.257|<0.0001
72338046|NCT01945775|144199601|SUPERIORITY||Hazard Ratio (HR)|0.392||||0.0053|TWO_SIDED|95.0|0.198|0.775|||Log Rank|||Hazard ratio is based on stratified Cox regression model with treatment as the only covariate (stratification factors: number of prior cytotoxic chemotherapy regimens, triple negative status, history of central nervous system).||0.775|0.198|0.0053
72338047|NCT02876328|144199602|SUPERIORITY||||||<|0.001||||||Each active group is compared to placebo using a 2-sided .0167 significance level.|Cochran-Mantel-Haenszel|Analyses are stratified by site.||Analysis applies to both adults and children.||||<.001
72338048|NCT00892606|144199605|SUPERIORITY|||||||0.0072|||||||ANOVA|||||||0.0072
72338049|NCT00892606|144199606|SUPERIORITY|||||||0.004|||||||ANOVA|||||||0.004
72338050|NCT00892606|144199607|SUPERIORITY|||||||0.0146|||||||ANOVA|||||||0.0146
72338051|NCT03840525|144199629|EQUIVALENCE|To estimate precision, 95%CI will be calculated using Wilson's score method, which uses asymptotic variance and is appropriate for small sample sizes100. The formula is as follows: (2np + z2 ± √(z2 + 4npq)) / 2(n+ z2). If the proportion of participants who rate the intervention as acceptable is 80% or greater, we will consider the intervention acceptable.|||||||||||||||||Descriptive statistics were conducted. No group comparisons were done due to the fact that this was a feasibility trial and not an efficacy trial. 80% was used as the benchmark for acceptability.|||
72338052|NCT03840525|144199630|EQUIVALENCE|To estimate precision, 95%CI will be calculated using Wilson's score method, which uses asymptotic variance and is appropriate for small sample sizes100. The formula is as follows: (2np + z2 ± √(z2 + 4npq)) / 2(n+ z2). If the proportion of participants who rate the intervention as acceptable is 80% or greater, we will consider the intervention acceptable.|||||||||||||||||Descriptive statistics was conducted to determine acceptability for both the qigong and sham qigong group. No between group comparisons were conducted. A benchmark of 80% was used to determine acceptability.|||
72338053|NCT03840525|144199631|EQUIVALENCE|To estimate precision, 95%CI will be calculated using Wilson's score method, which uses asymptotic variance and is appropriate for small sample sizes100. The formula is as follows: (2np + z2 ± √(z2 + 4npq)) / 2(n+ z2). If the proportion of participants who rate the intervention as acceptable is 80% or greater, we will consider the intervention acceptable.|||||||||||||||||Descriptive statistics were conducted to determine acceptability. Benchmark for acceptability was set at 80% of participant attending at least 70% of the classes.|||
72338054|NCT01370837|144199641|SUPERIORITY_OR_OTHER|||||||0.84|TWO_SIDED||||||Kruskal-Wallis|||Arm||||0.84
72338055|NCT01370837|144199641|SUPERIORITY_OR_OTHER|||||||0.76|TWO_SIDED||||||Kruskal-Wallis|||Foot||||0.76
72338056|NCT01370837|144199641|SUPERIORITY_OR_OTHER|||||||0.53|TWO_SIDED||||||Kruskal-Wallis|||Arm||||0.53
72338057|NCT01370837|144199641|SUPERIORITY_OR_OTHER|||||||0.07|TWO_SIDED||||||Kruskal-Wallis|||Foot||||0.07
72338058|NCT01370837|144199641|SUPERIORITY_OR_OTHER|||||||0.25|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Arm vs foot||||0.25
72338059|NCT01370837|144199641|SUPERIORITY_OR_OTHER|||||||0.27|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Arm vs foot||||0.27
72338060|NCT01370837|144199641|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Arm vs foot||||< 0.01
72338061|NCT04240093|144199658|SUPERIORITY|This is a pilot intervention trial and was not powered to detect statistical significance.|Beta coefficient|-0.46|STANDARD_ERROR_OF_MEAN|0.33||0.17|TWO_SIDED|95.0|-1.11|0.2||a priori alpha p\<0.05|Generalized estimating equations (GEE)|Generalized estimating equations (GEE) with a poisson distribution controlling for baseline values.||Hypothesis: The CoMBAT intervention arm would be superior to the Standard of Care control arm with regard to reductions in missed medication doses in the past 30 days at follow-up.||0.20|-1.11|0.17
72338062|NCT04240093|144199659|SUPERIORITY|This pilot feasibility and acceptability study was not powered to detect a statistically significant effect.|Beta coefficient|-0.18|STANDARD_ERROR_OF_MEAN|1.48||0.9|TWO_SIDED|95.0|-3.09|2.72||a priori alpha p\<0.05|Generalized estimating equation (GEE)|Generalized estimating equations (GEE) with a Poisson distribution controlling for baseline values.||Hypothesis: The CoMBAT intervention arm would be superior to the Standard of Care control arm with regard to reductions in missed medication-related visits in the past 30 days at follow-up.||2.72|-3.09|0.90
72338063|NCT04240093|144199660|SUPERIORITY|As a pilot feasibility and acceptability trial, this study was not powered to detect a statistically significant effect.|Beta coefficient|-4.71|STANDARD_ERROR_OF_MEAN|2.05||0.02|TWO_SIDED|95.0|-8.72|-0.7||A priori alpha p\<0.05|Generalized estimating equations (GEE)|Generalized estimating equation (GEE) modeling with a binomial distribution, controlling for baseline values.||Hypothesis: Fewer participants in the CoMBAT experimental arm will have a positive opioid toxicology screen at the 6-month follow-up compared to participants in the SOC control arm.||-0.70|-8.72|0.02
72338064|NCT02839902|144199661|OTHER|Least square (LS) mean difference|Least square (LS) mean difference|-17.147||||0.0004|TWO_SIDED|95.0|-26.344|-7.95|||ANCOVA||TAK-085 4 g - Control Group|The least square (LS) mean percentage change was compared between treatment groups with cholesterol concentration in sd LDL fraction at Week 8 using an ANCOVA model.||-7.950|-26.344|0.0004
72338065|NCT02839902|144199661|OTHER|Least square (LS) mean difference|Least square (LS) mean difference|-9.774||||0.1141|TWO_SIDED|95.0|-21.986|2.439|||ANCOVA||TAK-085 4 g - Control Group|The least square (LS) mean percentage change was compared between treatment groups with triglycerides concentration in sd LDL fraction at Week 8 using an ANCOVA model.||2.439|-21.986|0.1141
72338066|NCT02839902|144199661|OTHER|Least square (LS) mean difference|Least square (LS) mean difference|-10.246||||0.0248|TWO_SIDED|95.0|-19.143|-1.349|||ANCOVA||TAK-085 4 g - Control Group|The least square (LS) mean percentage change was compared between treatment groups with free cholesterol concentration in sd LDL fraction at Week 8 using an ANCOVA model.||-1.349|-19.143|0.0248
72338067|NCT02839902|144199661|OTHER|Least square (LS) mean difference|Least square (LS) mean difference|-11.511||||0.0047|TWO_SIDED|95.0|-19.34|-3.682|||ANCOVA||TAK-085 4 g - Control Group|The least square (LS) mean percentage change was compared between treatment groups with phospholipid concentration in sd LDL fraction at Week 8 using an ANCOVA model.||-3.682|-19.340|0.0047
72338068|NCT02839902|144199662|OTHER|Least square (LS) mean difference|Least square (LS) mean difference|9.499||||0.1826|TWO_SIDED|95.0|-4.623|23.622|||ANCOVA||TAK-085 4 g - Control Group|The least square (LS) mean percentage change was compared between treatment groups with TG to cholesterol ratio in sd LDL fraction at Week 8 using an ANCOVA model.||23.622|-4.623|0.1826
72338069|NCT02839902|144199663|OTHER|Least square (LS) mean difference|Least square (LS) mean difference|1.066||||0.004|TWO_SIDED|95.0|0.356|1.776|||ANCOVA||TAK-085 4 g - Control Group|The least square (LS) mean percentage change was compared between treatment groups with particle size (nm) of LDL at Week 8 monitored by cholesterol using an ANCOVA model.||1.776|0.356|0.0040
72338070|NCT02839902|144199663|OTHER|Least square (LS) mean difference|Least square (LS) mean difference|1.553||||0.4428|TWO_SIDED|95.0|-2.884|5.991|||ANCOVA||TAK-085 4 g - Control Group|The least square (LS) mean percentage change was compared between treatment groups with particle size (nm) of LDL at Week 8 monitored by triglycerides using an ANCOVA model.||5.991|-2.884|0.4428
72338071|NCT02839902|144199663|OTHER|Least square (LS) mean difference|Least square (LS) mean difference|0.76||||0.057|TWO_SIDED|95.0|-0.024|1.544|||ANCOVA||TAK-085 4 g - Control Group|The least square (LS) mean percentage change was compared between treatment groups with particle size (nm) of LDL at Week 8 monitored by free cholesterol using an ANCOVA model.||1.544|-0.024|0.0570
72338072|NCT02839902|144199663|OTHER|Least square (LS) mean difference|Least square (LS) mean difference|0.838||||0.036|TWO_SIDED|95.0|0.057|1.62|||ANCOVA||TAK-085 4 g - Control Group|The least square (LS) mean percentage change was compared between treatment groups with particle size (nm) of LDL at Week 8 monitored by phospholipid using an ANCOVA model.||1.620|0.057|0.0360
72428070|NCT03354637|144367347|SUPERIORITY|||||||0.859|||||||Wilcoxon (Mann-Whitney)|||||||0.859
72338073|NCT00740714|144199686|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.59|STANDARD_ERROR_OF_MEAN|0.85|>|0.025|TWO_SIDED|97.5|-1.33|2.51||The primary analysis compares each active treatment arm to the placebo arm. P-values for efficacy outcomes will be 2-sided, with a Bonferroni-adjusted significance level of .025 used to preserve the overall alpha level for the 2 comparisons at .05.|ANCOVA|||ANCOVA is used with the change in total UPDRS of Coenzyme Q10 1200 mg/day arm compared to placebo group.||2.51|-1.33|>0.025
72338074|NCT00740714|144199686|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.09|STANDARD_ERROR_OF_MEAN|0.86|>|0.025|TWO_SIDED|95.0|-0.85|3.03||The primary analysis compares each active treatment arm to the placebo arm. P-values for efficacy outcomes will be 2-sided, with a Bonferroni-adjusted significance level of .025 used to preserve the overall alpha level for the 2 comparisons at .05.|ANCOVA|||ANCOVA is used with the change in total UPDRS of Coenzyme Q10 2400 mg/day arm compared to placebo group.||3.03|-0.85|>0.025
72338075|NCT00740714|144199687|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.22|STANDARD_ERROR_OF_MEAN|0.84||0.7943|TWO_SIDED|97.5|-2.12|1.68||The primary analysis compares each active treatment arm to the placebo arm. P-Values for efficacy outcomes are 2-sided, with a Bonferroni-adjusted significance level of .025 used to preserve the overall alpha level for the 2 comparisons at .05.|ANCOVA|COCF is used for missing data and those lost to follow up. Outliers and non-compliant patients are assessed with scatter and residual plots and ITT.||Change from Baseline Visit to 16-month visit on Modified Schwab \& England will be analyzed using ANCOVA in the same way as for the primary outcome variable.||1.68|-2.12|0.7943
72338076|NCT00740714|144199687|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.87|STANDARD_ERROR_OF_MEAN|0.85||0.306||95.0|-2.79|1.04||The primary analysis compares each active treatment arm to the placebo arm. P-Values for efficacy outcomes are 2-sided, with a Bonferroni-adjusted significance level of .025 used to preserve the overall alpha level for the 2 comparisons at .05|ANCOVA|COCF is used for missing data and those lost to follow up. Outliers and non-compliant patients are assessed with scatter and residual plots and ITT.||Change from Baseline Visit to 16-month on Modified Schwab \& England will be analyzed using ANCOVA in the same way as for the primary outcome variable.||1.04|-2.79|0.306
72428071|NCT03354637|144367348|SUPERIORITY|||||||0.481|||||||Wilcoxon (Mann-Whitney)|||||||0.481
72428072|NCT03354637|144367348|SUPERIORITY|||||||0.357|||||||Wilcoxon (Mann-Whitney)|||||||0.357
72338077|NCT00740714|144199688|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.09|STANDARD_ERROR_OF_MEAN|0.06|<|0.1615|TWO_SIDED|97.5|-0.25|0.06||The primary analysis compares each active treatment arm to the placebo arm. P-Values for efficacy outcomes are 2-sided, with a Bonferroni-adjusted significance level of .025 used to preserve the overall alpha level for the 2 comparisons at .05.|ANCOVA|COCF is used for missing data and those lost to follow up. Outliers and non-compliant patients are assessed with scatter and residual plots and ITT.||Change from Baseline Visit to 16-month visit on Modified Rankin Scale will be analyzed using ANCOVA in the same way as for the primary outcome variable.||0.06|-0.25|<0.1615
72338078|NCT00740714|144199688|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.02|STANDARD_ERROR_OF_MEAN|0.07||0.7627|TWO_SIDED|95.0|-0.17|0.13||The primary analysis compares each active treatment arm to the placebo arm. P-Values for efficacy outcomes are 2-sided, with a Bonferroni-Adjusted significance level of .025 used to preserve the overall alpha level for the 2 comparisons at .05.|ANCOVA|COCF is used for missing data and those lost to follow up. Outliers and non-compliant patients are assessed with scatter and residual plats and ITT.||Change from Baseline Visit to 16-month visit on Modified Rankin will be analyzed using ANCOVA in the same way as for the primary outcome variable.||0.13|-0.17|0.7627
72338079|NCT00740714|144199689|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.6383|STANDARD_ERROR_OF_MEAN|1.18||0.6383|TWO_SIDED|97.5|-2.1|3.21||The primary analysis compares each active treatment arm to the placebo arm. P-Values for efficacy outcomes are 2-sided, with a Bonferroni-adjusted significance level of .025 used to preserve the overall alpha level for the 2 comparisons at .05.|ANCOVA|COCF is used for missing data and those lost to follow up. Outliers and non-compliant patients are assessed with scatter and residual plots and ITT.||Change from Baseline Visit to 16-month visit on PD Quality of Life Scale will be analyzed using ANCOVA in the same way as for the primary outcome variable.||3.21|-2.10|0.6383
72338080|NCT00740714|144199689|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.51|STANDARD_ERROR_OF_MEAN|1.19||0.667|TWO_SIDED|95.0|-3.2|2.17||The primary analysis compares each active treatment arm to the placebo arm. P-Values for efficacy outcomes are 2-sided, with a Bonferroni-adjusted significance level of .025 used to preserve the overall alpha level for the 2 comparisons at .05.|ANCOVA|COCF is used for missing data and those lost to follow up. Outliers and non-compliant patients are assessed with scatter and residual plots and ITT.||Change from Baseline Visit to 16-month visit on PD Quality of Life Scale will be analyzed using ANCOVA in the same way as for the primary outcome variable.||2.17|-3.20|0.667
72338081|NCT00740714|144199690|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.49|STANDARD_ERROR_OF_MEAN|1.14||0.671|TWO_SIDED|97.5|-2.09|3.06||The primary analysis compares each active treatment arm to the placebo arm. P-Values for efficacy outcomes are 2-sided, with a Bonferroni-adjusted significance level of .025 used to preserve the overall alpha level for the 2 comparisons at .05.|ANCOVA|COCF is used for missing data and those lost to follow up. Outliers and non-compliant patients are assessed with scatter and residual plots and ITT.||Change from Baseline Visit to 16-month visit on Symbol Digit Modalities Test will be analyzed using ANCOVA in the same way as for the primary outcome variable.||3.06|-2.09|0.671
72338082|NCT00740714|144199690|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.74|STANDARD_ERROR_OF_MEAN|1.16||0.671|TWO_SIDED|95.0|-3.34|1.87||The primary analysis compares each active treatment arm to the placebo arm. P-Values for efficacy outcomes are 2-sided, with a Bonferroni-adjusted significance level of .025 used to preserve the overall alpha level for the 2 comparisons at .05|ANCOVA|COCF is used for missing data and those lost to follow up. Outliers and non-compliant patients are assessed with scatter and residual plots and ITT.||Change from Baseline Visit to 16-month visit on Symbol Digit Modalities Test will be analyzed using ANCOVA in the same way as for the primary outcome variable||1.87|-3.34|0.671
72338083|NCT00740714|144199691|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.04|STANDARD_ERROR_OF_MEAN|0.04||0.3445|TWO_SIDED|97.5|-0.04|0.13||The primary analysis compares each active treatment arm to the placebo arm. P-Values for efficacy outcomes are 2-sided, with a Bonferroni-adjusted significance level of .025 used to preserve the overall alpha level for the 2 comparisons at .05.|ANCOVA|COCF is used for missing data and those lost to follow up. Outliers and non-compliant patients are assessed with scatter and residual plots and ITT.||Change from Baseline Visit to 16-month visit on Hoehn \& Yahr Score will be analyzed using ANCOVA in the same way as for the primary outcome variable.||0.13|-0.04|0.3445
72338084|NCT00740714|144199691|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.04|STANDARD_ERROR_OF_MEAN|0.05||0.239||95.0|-0.04|0.14||The primary analysis compares each active treatment arm to the placebo arm. P-Values for efficacy outcomes are 2-sided. with a Bonferroni-adjustd significance level of .025 used to preserve the overall alpha level for the 2 comparisons at .05.|ANCOVA|COCF is used for missing data and those lost to follow up. Outliers and non-compliant patients are assess with scatter and residual plots and ITT.||Change from Baseline visit to 16-month visit on Hoehn \& Yahr will be analyzed using ANCOVA in the same way as for the primary outcome variable.||0.14|-0.04|.239
72338085|NCT00740714|144199692|SUPERIORITY_OR_OTHER||Slope|0.536|STANDARD_ERROR_OF_MEAN|0.282||0.0577|TWO_SIDED|95.0|-0.018|1.091|||ANOVA|The ANOVA is using UPDRS worsening as outcome, Change of CoQ10 level as predictor, adjusting for site and baseline UPDRS score.||The analysis will be using the actual change of plasma levels of CoQ10(from final visit to baseline) as predictors of UPDRS worsening. Correlation of UPDRS worsening with plasma levels of CoQ10 will be calculated for all treatment groups.||1.091|-0.018|0.0577
72338086|NCT00740714|144199692|SUPERIORITY_OR_OTHER||Slope|0.245|STANDARD_ERROR_OF_MEAN|0.451||0.5889|TWO_SIDED|95.0|-0.647|1.136|||ANOVA|The ANOVA is using UPDRS worsening as outcome, Change of CoQ10 level as predictor, adjusting for site and baseline UPDRS score.||The analysis will be using the actual change of plasma levels of CoQ10(from final to baseline) as predictors of UPDRS worsening. Correlation of UPDRS worsening with plasma levels of CoQ10 will be calculated for the treatment group of Coenzyme Q10 2400 mg/day.||1.136|-0.647|0.5889
72338087|NCT00740714|144199692|SUPERIORITY_OR_OTHER||Slope|0.631|STANDARD_ERROR_OF_MEAN|0.608||0.3006|TWO_SIDED|95.0|-0.569|1.831|||ANOVA|The ANOVA is using UPDRS worsening as outcome, Change of CoQ10 level as predictor, adjusting for site and baseline UPDRS score.||The analysis will be using the actual change of plasma levels of CoQ10(from final to baseline) as predictors of UPDRS worsening. Correlation of UPDRS worsening with plasma levels of CoQ10 will be calculated for the treatment group of Coenzyme Q10 1200 mg/day.||1.831|-0.569|0.3006
72428073|NCT02564055|144367350|OTHER||Difference in percentages|22.6|||||TWO_SIDED|95.0|-2.4|45.5|||||Difference between GSK2894512 1 percent BID and Vehicle BID has been presented.|||45.5|-2.4|
72338088|NCT00740714|144199692|SUPERIORITY_OR_OTHER||Slope|2.126|STANDARD_ERROR_OF_MEAN|1.269||0.096|TWO_SIDED|95.0|-0.382|4.633|||ANOVA|The ANOVA is using UPDRS worsening as outcome, Change of CoQ10 level as predictor, adjusting for site and baseline UPDRS score.||The analysis will be using the actual change of plasma levels of CoQ10(from final to baseline) as predictors of UPDRS worsening. Correlation of UPDRS worsening with plasma levels of CoQ10 will be calculated for the placebo group.||4.633|-0.382|0.096
72338089|NCT00740714|144199693|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.26|STANDARD_ERROR_OF_MEAN|0.0199|<|0.05|TWO_SIDED|95.0|0.57|2.8|||Fisher Exact||Odds ratio \>1 indicates a higher frequency in active treatment group.|All adverse experiences were tabulated by treatment group, severity and perceived relationship to study medication. Fisher's exact test was used to compare active treatment arms to the placebo arm with regard to the proportion of subjects experiencing a particular adverse experience.||2.80|0.57|<0.05
72338090|NCT00740714|144199694|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.49|STANDARD_ERROR_OF_MEAN|0.0198|<|0.05|TWO_SIDED|95.0|0.62|3.57|||Fisher Exact||Odds ratio \>1 indicates a higher frequency in active treatment group.|All adverse experiences were tabulated by treatment group, severity and perceived relationship to study medication. Fisher's exact test was used to compare active treatment arms to the placebo arm with regard to the proportion of subject experiencing a particular adverse experience||3.57|0.62|<0.05
72338091|NCT00740714|144199695|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.65|STANDARD_ERROR_OF_MEAN|0.0198|<|0.05|TWO_SIDED|95.0|0.65|4.2|||Fisher Exact||Odds ratio \>1 indicates a higher frequency in active treatment group.|All adverse experiences were tabulated by treatment group, severity and perceived relationship to study medication. Fisher's exact test was used to compare active treatment arms to the placebo arm with regard to the proportion of subjects experiencing a particular adverse experience.||4.20|0.65|<0.05
72338092|NCT00740714|144199696|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.91|STANDARD_ERROR_OF_MEAN|0.02|<|0.05|TWO_SIDED|95.0|0.46|1.79|||ANCOVA||Odds ratio \>1 indicates a higher frequency in active treatment group.|All adverse experiences were tabulated by treatment group, severity and perceived relationship to study medication. Fisher's exact test was used to compare active treatment arms to the placebo arm with regard to the proportion of subjects experiencing a particular adverse experience.||1.79|0.46|<0.05
72338093|NCT00740714|144199697|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.5|STANDARD_ERROR_OF_MEAN|0.0199|<|0.05|TWO_SIDED|95.0|0.66|3.41|||Fisher Exact||Odds ratio \>1 indicates a higher frequency in active treatment group.|All adverse experiences were tabulated by treatment group, severity and perceived relationship to study medication. Fisher's exact test was used to compare active treatment arms to the placebo arm with regard to the proportion of subjects experiencing a particular adverse experience.||3.41|0.66|<0.05
72338094|NCT00740714|144199698|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.8|STANDARD_ERROR_OF_MEAN|0.0197|<|0.05|TWO_SIDED|95.0|0.81|9.72|||Fisher Exact||Odds ratio \>1 indicates a higher frequency in active treatment group.|All adverse experiences were tabulated by treatment group, severity and perceived relationship to study medication. Fisher's exact test was used to compare active treatment arms to the placebo arm with regard to the proportion of subjects experiencing a particular adverse experience.||9.72|0.81|<0.05
72338095|NCT00740714|144199699|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.69|STANDARD_ERROR_OF_MEAN|0.0197|<|0.05|TWO_SIDED|95.0|0.31|1.52|||Fisher Exact||Odds ratio \>1 indicates a higher frequency in active treatment group.|All adverse experiences were tabulated by treatment group, severity and perceived relationship to study medication. Fisher's exact test was used to compare active treatment arms to the placebo arm with regard to the proportion of subjects experiencing a particular adverse experience.||1.52|0.31|<0.05
72338096|NCT00740714|144199700|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.78|STANDARD_ERROR_OF_MEAN|0.0197|<|0.05|TWO_SIDED|95.0|0.36|1.7|||Fisher Exact||Odds ratio \>1 indicates a higher frequency in active treatment group.|All adverse experiences were tabulated by treatment group, severity and perceived relationship to study medication. Fisher's exact test was used to compare active treatment arms to the placebo arm with regard to the proportion of subjects experiencing a particular adverse experience.||1.70|0.36|<0.05
72338097|NCT00740714|144199701|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.44|STANDARD_ERROR_OF_MEAN|0.0197|<|0.05|TWO_SIDED|95.0|0.69|8.58|||Fisher Exact||Odds ratio \>1 indicates a higher frequency in active treatment group.|All adverse experiences were tabulated by treatment group, severity and perceived relationship to study medication. Fisher's exact test was used to compare active treatment arms to the placebo arm with regard to the proportion of subjects experiencing a particular adverse experience.||8.58|0.69|<0.05
72338098|NCT00740714|144199702|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.71|STANDARD_ERROR_OF_MEAN|0.0197|<|0.05|TWO_SIDED|95.0|0.31|1.62|||Fisher Exact||Odds ratio \>1 indicates a higher frequency in active treatment group.|All adverse experiences were tabulated by treatment group, severity and perceived relationship to study medication. Fisher's exact test was used to compare active treatment arms to the placebo arm with regard to the proportion of subjects experiencing a particular adverse experience.||1.62|0.31|<0.05
72338099|NCT00740714|144199703|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|9999.98|STANDARD_ERROR_OF_MEAN|0.0196|<|0.05|TWO_SIDED|95.0|2.77|9999.99|||Fisher Exact||Odds ratio \>1 indicates a higher frequency in active treatment group.|All adverse experiences were tabulated by treatment group, severity and perceived relationship to study medication. Fisher's exact test was used to compare active treatment arms to the placebo arm with regard to the proportion of subjects experiencing a particular adverse experience.||9999.99|2.77|<0.05
72338100|NCT00740714|144199704|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.53|STANDARD_ERROR_OF_MEAN|0.0197|<|0.05|TWO_SIDED|95.0|0.25|1.12|||Fisher Exact||Odds ration \>1 indicates a higher frequency in active treatment group.|All adverse experiences were tabulated by treatment group, severity and perceived relationship to study medication. Fisher's exact test was used to compare active treatment arms to the placebo arm with regard to the proportion of subjects experiencing a particular adverse experience.||1.12|0.25|<0.05
72338101|NCT00740714|144199705|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.26|STANDARD_ERROR_OF_MEAN|0.0196|<|0.05|TWO_SIDED|95.0|0.64|8.01|||Fisher Exact||Odds ratio \>1 indicates a higher frequency in active treatment group.|All adverse experiences were tabulated by treatment group, severity and perceived relationship to study medication. Fisher's exact test was used to compare active treatment arms to the placebo arm with regard to the proportion of subjects experiencing a particular adverse experience.||8.01|0.64|<0.05
72428074|NCT02564055|144367350|OTHER||Difference in percentages|7.4|||||TWO_SIDED|95.0|-18.3|32.0|||||Difference between GSK2894512 1 percent QD and Vehicle QD has been presented.|||32.0|-18.3|
72338102|NCT00740714|144199706|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.33|STANDARD_ERROR_OF_MEAN|0.0198|<|0.05|TWO_SIDED|95.0|0.55|3.24|||Fisher Exact||Odds ratio of \>1 indicates a higher frequency in active treatment group.|All adverse experiences were tabulated by treatment group, severity and perceived relationship to study medication. Fisher's exact test was used to compare active treatment arms to the placebo arm with regard to the proportion of subjects experiencing a particular adverse experience.||3.24|0.55|<0.05
72338103|NCT00740714|144199707|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|9999.98|STANDARD_ERROR_OF_MEAN|0.0197|<|0.05|TWO_SIDED|95.0|0.48|9999.99|||Fisher Exact||Odds ratio \>1 indicates a higher frequency in active treatment group.|All adverse experiences were tabulated by treatment group, severity and perceived relationship to study medication. Fisher's exact test was used to compare active treatment arms to the placebo arm with regard to the proportion of subjects experiencing a particular adverse experience.||9999.99|0.48|<0.05
72338104|NCT00740714|144199708|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|9999.98|STANDARD_ERROR_OF_MEAN|0.0196|<|0.05|TWO_SIDED|95.0|2.51|9999.99|||Fisher Exact||Odds ratio \>1 indicates a higher frequency in active treatment group.|All adverse experiences were tabulated by treatment group, severity and perceived relationship to study medication. Fisher's exact test was used to compare active treatment arms to the placebo arm with regard to the proportion of subjects experiencing a particular adverse experience.||9999.99|2.51|<0.05
72338105|NCT01400243|144199740|SUPERIORITY_OR_OTHER|||||||0.05|TWO_SIDED||||||ANCOVA|||||||.05
72338106|NCT01400243|144199741|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||ANOVA|||||||<0.05
72338107|NCT02193087|144199745|NON_INFERIORITY_OR_EQUIVALENCE|Based on the Two One-Sided Tests (TOST) with α=0.05, if the 90% CI for the ratio of GMT for a given dengue serotype for the comparison was within the range of 0.67 and 1, then the 2 formulations were deemed equivalent.|LS Mean Ratio|0.29|||||TWO_SIDED|90.0|0.23|0.36||||||DEN-1||0.36|0.23|
72338108|NCT02193087|144199745|NON_INFERIORITY_OR_EQUIVALENCE|Based on the Two One-Sided Tests (TOST) with α=0.05, if the 90% CI for the ratio of GMT for a given dengue serotype for the comparison was within the range of 0.67 and 1, then the 2 formulations were deemed equivalent.|LS Mean Ratio|1.06|||||TWO_SIDED|90.0|0.9|1.26||||||DEN-2||1.26|0.90|
72338109|NCT02193087|144199745|NON_INFERIORITY_OR_EQUIVALENCE|Based on the Two One-Sided Tests (TOST) with α=0.05, if the 90% CI for the ratio of GMT for a given dengue serotype for the comparison was within the range of 0.67 and 1, then the 2 formulations were deemed equivalent.|LS Mean Ratio|1.46|||||TWO_SIDED|90.0|1.13|1.89||||||DEN-3||1.89|1.13|
72338110|NCT02193087|144199745|NON_INFERIORITY_OR_EQUIVALENCE|Based on the Two One-Sided Tests (TOST) with α=0.05, if the 90% CI for the ratio of GMT for a given dengue serotype for the comparison was within the range of 0.67 and 1, then the 2 formulations were deemed equivalent.|LS Mean Ratio|0.74|||||TWO_SIDED|90.0|0.57|0.95||||||DEN-4||0.95|0.57|
72338111|NCT02032641|144199759|SUPERIORITY_OR_OTHER||||||<|0.05||||||The threshold for significance is p\<0.05|t-test, 1 sided|||||||<0.05
72338112|NCT02032641|144199759|SUPERIORITY_OR_OTHER||||||>|0.1||||||The threshold for significance is p\<0.05|t-test, 1 sided|||||||>0.10
72338113|NCT01048866|144199761|SUPERIORITY_OR_OTHER||least-square means difference|-196.6||||0.0021|TWO_SIDED|95.0|-321.0|-72.2||The a priori threshold for statistical significance is 0.05.|ANOVA|||||-72.2|-321.0|0.0021
72338114|NCT01048866|144199762|SUPERIORITY_OR_OTHER||least-square means difference|-19.0||||0.0002|TWO_SIDED|95.0|-28.7|-9.3||The a priori threshold for statistical significance is 0.05.|ANOVA|Baseline DSS fitted as a covariate and centre as a fixed effect.||||-9.3|-28.7|0.0002
72338115|NCT01048866|144199763|SUPERIORITY_OR_OTHER||least-square means difference|-179.7||||0.0054|TWO_SIDED|95.0|-305.7|-53.8||The a priori threshold for statistical significance is 0.05.|ANOVA|||||-53.8|-305.7|0.0054
72338116|NCT01048866|144199764|SUPERIORITY_OR_OTHER||least-square means difference|-16.4||||0.0008|TWO_SIDED|95.0|-25.9|-7.0||The a priori threshold for statistical significance is 0.05.|ANOVA|||||-7.0|-25.9|0.0008
72338117|NCT01048866|144199765|SUPERIORITY_OR_OTHER||least-square means difference|-168.4||||0.0087|TWO_SIDED|95.0|-293.7|-43.1|||ANOVA|||||-43.1|-293.7|0.0087
72338118|NCT01048866|144199766|SUPERIORITY_OR_OTHER||least-square means difference|-19.0|||<|0.0001|TWO_SIDED|95.0|-28.0|-10.0|||ANOVA|Baseline STPIS fitted as a covariate and centre as a fixed effect.||||-10.0|-28.0|<0.0001
72338119|NCT01048866|144199767|SUPERIORITY_OR_OTHER||least-square means difference|-118.9||||0.1844|TWO_SIDED|95.0|-295.3|57.5|||ANOVA|Baseline STPIS fitted as a covariate and centre as a fixed effect.||||57.5|-295.3|0.1844
72338120|NCT01048866|144199768|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
72338121|NCT01048866|144199769|SUPERIORITY_OR_OTHER|||||||0.8827|||||||Wilcoxon (Mann-Whitney)|||||||0.8827
72338122|NCT01048866|144199770|SUPERIORITY_OR_OTHER|||||||0.0105|||||||Wilcoxon (Mann-Whitney)|Stratified by centre||||||0.0105
72338123|NCT01048866|144199772|SUPERIORITY_OR_OTHER||least-square means difference|-5.9||||0.0743|TWO_SIDED|95.0|-12.4|0.6|||ANOVA|Repeated measures ANOVA model with participant as a random effect.||||0.6|-12.4|0.0743
72338124|NCT01048866|144199773|SUPERIORITY_OR_OTHER||least-square means difference|-5.5||||0.0871|TWO_SIDED|95.0|-11.7|0.8|||ANOVA|Repeated measures ANOVA model with patient as a random effect.||||0.8|-11.7|0.0871
72338125|NCT01048866|144199774|SUPERIORITY_OR_OTHER||least-square means difference|-6.0||||0.0595|TWO_SIDED|95.0|-12.3|0.2|||ANOVA|Repeated measures ANOVA model with participant as a random effect.||||0.2|-12.3|0.0595
72338126|NCT01048866|144199775|SUPERIORITY_OR_OTHER||least-square means difference|0.5||||0.0195|TWO_SIDED|95.0|0.1|0.9|||ANOVA|Repeated measures ANOVA model with participant as a random effect.||||0.9|0.1|0.0195
72338127|NCT01048866|144199776|SUPERIORITY_OR_OTHER|||||||0.0322|||||||Regression, Logistic|Effect for centre||||||0.0322
72338128|NCT01048866|144199777|SUPERIORITY_OR_OTHER|||||||0.0276|||||||Log Rank|||||||0.0276
72338129|NCT01048866|144199778|SUPERIORITY_OR_OTHER||least-square means difference|-0.2||||0.0288|TWO_SIDED|95.0|-0.4|0.0|||ANOVA|||||-0.0|-0.4|0.0288
72338130|NCT01048866|144199779|SUPERIORITY_OR_OTHER||least-square means difference|-0.1||||0.4274|TWO_SIDED|95.0|-0.3|0.1|||ANOVA|||||0.1|-0.3|0.4274
72338131|NCT01460719|144199823|OTHER|The statistical criterion for significance requires that the lower bound of the 2-sided 90% confidence interval of the GMFR is \>1.0.|||||<|0.001|||||||Single longitudinal regression model|Adjustments made for pre-vaccination values||||||<0.001
72338132|NCT01151761|144199830|SUPERIORITY_OR_OTHER||months|8.5|||||TWO_SIDED|95.0|7.0|10.0|||||There were only two patients in the study. Both died without having any local failure. One patient died at 10 months, the other at 7 months. The range for the 95%CI is both the full range and the 95%CI.|The median Progression Free Survival (PFS) time as calculated using Kaplan Meier methodology. For PFS both death and progression are counted as events.||10|7|
72338133|NCT01151761|144199835|SUPERIORITY_OR_OTHER||proportion of participants|0.0|||||TWO_SIDED||||||||None of the two patients who participated had a local recurrence before they died.|||||
72338134|NCT02838901|144199838|OTHER|This was a descriptive analysis, and was based on the overall assessment of feasibility of the intervention.||||||0.058||||||The p value is not adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|||The null hypothesis was used, and the assumption was there would be no difference in adherence between the Active Juice and the Placebo Juice, and therefore a two-sided t approximation was reported. Since this was a pilot study, power calculations were not performed. The adherence in the two groups was compared using the Wilcoxon two-sample test.||||0.058
72338135|NCT02838901|144199839|OTHER|This was a descriptive analysis and was under the goal of assessing safety of the intervention.||||||1|||||||Fisher Exact|||Null hypothesis was assumed, no power calculation was done since this was a pilot study.||||1.00
72338136|NCT02838901|144199840|OTHER|||||||0.0003|||||||Wilcoxon (Mann-Whitney)|||The null hypothesis was assumed, and no power calculation was performed since this was a pilot study.||||0.0003
72338137|NCT02838901|144199841|OTHER|This was a descriptive analysis for a pilot study, and no power calculations were performed.||||||0.1023|||||||Wilcoxon (Mann-Whitney)|||||||0.1023
72338138|NCT02838901|144199842|OTHER|This was a descriptive analysis for a pilot study to gather preliminary data for a larger trial. No power calculations were performed for this outcome.||||||0.9581|||||||Wilcoxon (Mann-Whitney)|||||||.9581
72338139|NCT02838901|144199842|OTHER|||||||0.6678|||||||Wilcoxon (Mann-Whitney)|||The null hypothesis was assumed, and no power calculation was performed since this was a pilot study and the purpose was to collect preliminary data for a larger trial.||||.6678
72338140|NCT02838901|144199844|OTHER|||||||1|||||||Wilcoxon (Mann-Whitney)|||||||1.000
72338141|NCT02838901|144199844|OTHER|||||||0.876|||||||Wilcoxon (Mann-Whitney)|||||||.876
72338142|NCT02838901|144199845|OTHER|||||||0.889|||||||Wilcoxon (Mann-Whitney)|||||||.889
72338143|NCT02838901|144199845|OTHER|||||||0.532|||||||Wilcoxon (Mann-Whitney)|||||||0.532
72338144|NCT02838901|144199846|OTHER|||||||0.888|||||||Wilcoxon (Mann-Whitney)|||||||0.888
72338145|NCT02838901|144199847|OTHER|||||||0.475|||||||Wilcoxon (Mann-Whitney)|||||||0.475
72338146|NCT02838901|144199848|OTHER|||||||0.135|||||||Wilcoxon (Mann-Whitney)|||||||0.135
72338147|NCT02838901|144199849|OTHER|||||||0.185|||||||Wilcoxon (Mann-Whitney)|||||||0.185
72338148|NCT03397134|144199879|SUPERIORITY|All statistical tests will be 2-sided hypothesis tests performed at the 5% level of significance. All confidence intervals will be 2-sided 95% confidence intervals||||||0.043||||||The p-values must be ≤0.025 to allow for rejecting the null hypothesis for the representative dose.|Mixed Models Analysis|The Kenward-Roger approximation will be used to estimate denominator degrees of freedom.||To evaluate the efficacy of 2 fixed doses (32 mg and 64 mg) of MIN-101 compared to placebo in improving the negative symptoms of schizophrenia as measured by the change from Baseline in the PANSS Marder negative symptoms factor score (NSFS) over 12 weeks of double-blind treatment. Approximation 501 eligible patients will be randomized in a 2:2:1:1 ratio at baseline to 1 of 4 treatment arms.||||0.043
72338149|NCT03397134|144199880|SUPERIORITY|All statistical tests will be 2-sided hypothesis tests performed at the 5% level of significance. All confidence intervals will be 2-sided 95% confidence intervals.||||||0.016||||||The p-values must be ≤0.025 to allow for rejecting the null hypothesis for the representative dose.|Mixed Models Analysis|The Kenward-Roger approximation will be used to estimate denominator degrees of freedom.||The PSP involves four subscale domains: (a) socially useful activities, (b) personal and social relationships, (c) self-care, and (d) disturbing and aggressive behaviors. After each of these four areas is scored on an anchored Likert-type scale (0-5), raters are instructed to select a 10-point range within a 100-point scale, guided by the area scores assigned during assessment.||||0.016
72338150|NCT05257148|144199937|SUPERIORITY||Mean Difference (Final Values)|-9.3|||<|0.001|TWO_SIDED||||||t-test, 2 sided|||||||<0.001
72338151|NCT03554772|144199972|SUPERIORITY||||||<|0.0001||||||p-value for each dose group vs placebo comparison|ANCOVA|ANCOVA model included treatment as main effect , baseline NPRS and basline BMI as covariates P-value is Dunnett adjusted (individual treatment arms)||||||<0.0001
72338152|NCT03060512|144200031|OTHER|||||||0.9239|||||||Prescott's test|||Assessment of the difference in preference for the two treatments (Prefer Movantik, No Preference, Prefer PEG 3350) in subjects who completed the entire treatment sequence.||||0.9239
72338153|NCT03060512|144200031|OTHER|||||||0.8874|||||||Prescott's test|||Assessment of the difference between preference for treatment in Period 1, preference for treatment in Period 2, no preference||||0.8874
72338154|NCT03060512|144200034|OTHER||Least Squares (LS) Means difference|0.0|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|-0.3|0.3||||||Analysis of variance (ANOVA) model assessing treatment difference in PGIC at Visits 3 and 5 between Movantik and PEG 3350 treatment. Adjustments were performed for treatment, period and sequence.||0.3|-0.3|
72428075|NCT02564055|144367350|OTHER||Difference in percentages|14.3|||||TWO_SIDED|95.0|-11.2|38.7|||||Difference between GSK2894512 0.5 percent BID and Vehicle BID has been presented.|||38.7|-11.2|
72338155|NCT03060512|144200036|OTHER||LS Means difference|-0.9|STANDARD_ERROR_OF_MEAN|1.95|||TWO_SIDED|95.0|-4.7|3.0||||||Analysis of Covariance (ANCOVA) model assessing treatment difference in BFI change from baseline at Visits 3/5 between Movantik and PEG 3350. Adjustments were performed for for baseline BFI score, treatment, period and sequence.||3.0|-4.7|
72338156|NCT02370004|144200038|OTHER|||||||0.1|||||||t-test, 2 sided|||Paired T-tests were used to evaluate changes in spirometry results||||.10
72338157|NCT00241631|144200042|SUPERIORITY|||||||0.012|||||||Mixed Models Analysis|||||||0.012
72338158|NCT00241631|144200043|SUPERIORITY||||||<|0.05||||||calculated|Mixed Models Analysis|||||||<0.05
72338159|NCT00241631|144200044|SUPERIORITY||||||<|0.05||||||calculated|Mixed Models Analysis|||||||<0.05
72338160|NCT03883113|144200053|OTHER|||||||0.1711|||||||Wilcoxon (Mann-Whitney)|||||||0.1711
72338161|NCT03883113|144200053|OTHER|||||||0.1654|||||||Wilcoxon (Mann-Whitney)|||||||0.1654
72428076|NCT02564055|144367350|OTHER||Difference in percentages|-4.0|||||TWO_SIDED|95.0|-29.3|21.6|||||Difference between GSK2894512 0.5 percent QD and Vehicle QD has been presented.|||21.6|-29.3|
72428077|NCT02564055|144367358|OTHER||Difference in percentages|21.1|||||TWO_SIDED|95.0|-2.7|43.1|||||Difference between GSK2894512 1 % BID and Vehicle BID at Week 1 has been presented.|||43.1|-2.7|
72428078|NCT02564055|144367358|OTHER||Difference in percentages|26.5|||||TWO_SIDED|95.0|3.3|47.5|||||Difference between GSK2894512 1 % QD and Vehicle QD at Week 1 has been presented.|||47.5|3.3|
72428079|NCT02564055|144367358|OTHER||Difference in percentages|2.3|||||TWO_SIDED|95.0|-19.5|24.5|||||Difference between GSK2894512 0.5 % BID and Vehicle BID at Week 1 has been presented.|||24.5|-19.5|
72428080|NCT02564055|144367358|OTHER||Difference in percentages|9.1|||||TWO_SIDED|95.0|-14.5|32.0|||||Difference between GSK2894512 0.5 % QD and Vehicle QD at Week 1 has been presented.|||32.0|-14.5|
72428081|NCT02564055|144367358|OTHER||Difference in percentages|23.1|||||TWO_SIDED|95.0|-0.3|44.6|||||Difference between GSK2894512 1 % BID and Vehicle BID at Week 2 has been presented.|||44.6|-0.3|
72428082|NCT02564055|144367358|OTHER||Difference in percentages|37.7|||||TWO_SIDED|95.0|14.7|57.6|||||Difference between GSK2894512 1 % QD and Vehicle QD at Week 2 has been presented.|||57.6|14.7|
72338162|NCT03883113|144200053|OTHER|||||||0.1711|||||||Wilcoxon (Mann-Whitney)|||||||0.1711
72428083|NCT02564055|144367358|OTHER||Difference in percentages|5.1|||||TWO_SIDED|95.0|-18.0|27.8|||||Difference between GSK2894512 0.5 % BID and Vehicle BID at Week 2 has been presented.|||27.8|-18.0|
72428084|NCT02564055|144367358|OTHER||Difference in percentages|17.1|||||TWO_SIDED|95.0|-6.4|39.0|||||Difference between GSK2894512 0.5 % QD and Vehicle QD at Week 2 has been presented.|||39.0|-6.4|
72428085|NCT02564055|144367358|OTHER||Difference in percentages|39.6|||||TWO_SIDED|95.0|16.0|60.0|||||Difference between GSK2894512 1 % BID and Vehicle BID at Week 4 has been presented.|||60.0|16.0|
72428086|NCT02564055|144367358|OTHER||Difference in percentages|31.2|||||TWO_SIDED|95.0|7.8|52.1|||||Difference between GSK2894512 1 % QD and Vehicle QD at Week 4 has been presented.|||52.1|7.8|
72428087|NCT02564055|144367358|OTHER||Difference in percentages|26.5|||||TWO_SIDED|95.0|2.3|48.4|||||Difference between GSK2894512 0.5 % BID and Vehicle BID at Week 4 has been presented.|||48.4|2.3|
72428088|NCT02564055|144367358|OTHER||Difference in percentages|18.3|||||TWO_SIDED|95.0|-5.3|40.5|||||Difference between GSK2894512 0.5 % QD and Vehicle QD at Week 4 has been presented.|||40.5|-5.3|
72428089|NCT02564055|144367358|OTHER||Difference in percentages|21.9|||||TWO_SIDED|95.0|-2.3|44.7|||||Difference between GSK2894512 1 % BID and Vehicle BID at Week 8 has been presented.|||44.7|-2.3|
72338163|NCT03883113|144200054|OTHER|||||||1|||||||Fisher Exact|||The statistical analysis applies to participants with Virologically confirmed Influenza-like Illness versus participants without Virologically confirmed Influenza-like Illness||||1.000
72338164|NCT03883113|144200055|OTHER|||||||0.143|||||||Fisher Exact|||This statistical analysis applies to participants with qPCR confirmed Influenza versus participants with no qPCR confirmed Influenza||||0.143
72338165|NCT03883113|144200056|OTHER|||||||0.3504|||||||Fisher Exact|||This statistical analysis applies to participants with qCulture confirmed Influenza versus participants without qCulture confirmed Influenza||||0.3504
72428090|NCT02564055|144367358|OTHER||Difference in percentages|36.3|||||TWO_SIDED|95.0|12.1|57.6|||||Difference between GSK2894512 1 % QD and Vehicle QD at Week 8 has been presented.|||57.6|12.1|
72428091|NCT02564055|144367358|OTHER||Difference in percentages|26.7|||||TWO_SIDED|95.0|1.7|49.0|||||Difference between GSK2894512 0.5 % BID and Vehicle BID at Week 8 has been presented.|||49.0|1.7|
72428092|NCT02564055|144367358|OTHER||Difference in percentages|23.4|||||TWO_SIDED|95.0|-1.5|46.1|||||Difference between GSK2894512 0.5 % QD and Vehicle QD at Week 8 has been presented.|||46.1|-1.5|
72428093|NCT02564055|144367358|OTHER||Difference in percentages|19.0|||||TWO_SIDED|95.0|-6.0|42.3|||||Difference between GSK2894512 1 % BID and Vehicle BID at Week 12 has been presented.|||42.3|-6.0|
72428094|NCT02564055|144367358|OTHER||Difference in percentages|-0.2|||||TWO_SIDED|95.0|-25.0|25.0|||||Difference between GSK2894512 1 % QD and Vehicle QD at Week 12 has been presented.|||25.0|-25.0|
72428095|NCT02564055|144367358|OTHER||Difference in percentages|32.6|||||TWO_SIDED|95.0|6.9|55.0|||||Difference between GSK2894512 0.5 % BID and Vehicle BID at Week 12 has been presented.|||55.0|6.9|
72428096|NCT02564055|144367358|OTHER||Difference in percentages|-9.7|||||TWO_SIDED|95.0|-34.6|16.1|||||Difference between GSK2894512 0.5 % QD and Vehicle QD at Week 12 has been presented.|||16.1|-34.6|
72428097|NCT02564055|144367358|OTHER||Difference in percentages|22.3|||||TWO_SIDED|95.0|-3.1|45.3|||||Difference between GSK2894512 1 % BID and Vehicle BID at Week 14 has been presented.|||45.3|-3.1|
72428098|NCT02564055|144367358|OTHER||Difference in percentages|6.3|||||TWO_SIDED|95.0|-19.5|31.5|||||Difference between GSK2894512 1 % QD and Vehicle QD at Week 14 has been presented.|||31.5|-19.5|
72428099|NCT02564055|144367358|OTHER||Difference in percentages|17.7|||||TWO_SIDED|95.0|-8.4|41.9|||||Difference between GSK2894512 0.5 % BID and Vehicle BID at Week 14 has been presented.|||41.9|-8.4|
72428100|NCT02564055|144367358|OTHER||Difference in percentages|7.8|||||TWO_SIDED|95.0|-17.8|33.1|||||Difference between GSK2894512 0.5 % QD and Vehicle QD at Week 14 has been presented.|||33.1|-17.8|
72428101|NCT02564055|144367358|OTHER||Difference in percentages|9.8|||||TWO_SIDED|95.0|-15.5|33.9|||||Difference between GSK2894512 1 % BID and Vehicle BID at Week 16 has been presented.|||33.9|-15.5|
72428102|NCT02564055|144367358|OTHER||Difference in percentages|5.8|||||TWO_SIDED|95.0|-19.7|30.5|||||Difference between GSK2894512 1 % QD and Vehicle QD at Week 16 has been presented.|||30.5|-19.7|
72428103|NCT02564055|144367358|OTHER||Difference in percentages|17.2|||||TWO_SIDED|95.0|-9.0|41.4|||||Difference between GSK2894512 0.5 % BID and Vehicle BID at Week 16 has been presented.|||41.4|-9.0|
72428104|NCT02564055|144367358|OTHER||Difference in percentages|-0.6|||||TWO_SIDED|95.0|-26.0|25.0|||||Difference between GSK2894512 0.5 % QD and Vehicle QD at Week 16 has been presented.|||25.0|-26.0|
72338166|NCT03883113|144200057|OTHER|||||||0.5558|||||||Log Rank|||||||0.5558
72338167|NCT03883113|144200058|OTHER|||||||0.6534|||||||Log Rank|||||||0.6534
72428105|NCT02564055|144367358|OTHER||Difference in percentages|33.3|||||TWO_SIDED|95.0|-31.9|90.6|||||Difference between GSK2894512 1 % BID and Vehicle BID at EW has been presented.|||90.6|-31.9|
72428106|NCT02564055|144367358|OTHER||Difference in percentages|-9.1|||||TWO_SIDED|95.0|-62.4|47.8|||||Difference between GSK2894512 1 % QD and Vehicle QD at EW has been presented.|||47.8|-62.4|
72428107|NCT02564055|144367358|OTHER||Difference in percentages|28.6|||||TWO_SIDED|95.0|-19.2|71.0|||||Difference between GSK2894512 0.5 % BID and Vehicle BID at EW has been presented.|||71.0|-19.2|
72338168|NCT03883113|144200059|OTHER|||||||0.5485|||||||Wilcoxon (Mann-Whitney)|||||||0.5485
72338169|NCT03883113|144200060|OTHER|||||||0.6753|||||||Wilcoxon (Mann-Whitney)|||||||0.6753
72338170|NCT03883113|144200061|OTHER|||||||0.711|||||||Log Rank|||||||0.711
72338171|NCT03883113|144200062|OTHER|||||||0.4689|||||||Log Rank|||||||0.4689
72338172|NCT03883113|144200065|OTHER|||||||0.5001|||||||Wilcoxon (Mann-Whitney)|||||||0.5001
72338173|NCT03883113|144200066|OTHER|||||||0.6799|||||||zero-inflated poisson model|||||||0.6799
72338174|NCT03883113|144200067|OTHER|||||||0.5911|||||||Wilcoxon (Mann-Whitney)|||||||0.5911
72338175|NCT01457950|144200075|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.21|||<|0.0001|TWO_SIDED|95.0|2.06|4.36|||ANCOVA|||||4.36|2.06|<0.0001
72338176|NCT00435162|144200112|SUPERIORITY_OR_OTHER||Slope|-1.05||||0.099|TWO_SIDED|95.0|-2.31|0.2|||Regression, Linear|||Slope change across all 3 active treatment groups.||0.20|-2.31|0.0990
72338177|NCT02963987|144200116|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
72338178|NCT02963987|144200117|SUPERIORITY|||||||0.006|||||||Mixed Models Analysis|||||||0.006
72338179|NCT02963987|144200118|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
72338180|NCT00334282|144200146|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.46||||1e-07||95.0|0.34|0.62||stratified log-rank test|Log Rank||The estimated value is the hazard ratio comparing pazopanib to placebo.|||0.62|0.34|.0000001
72338181|NCT01689350|144200157|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.99|||<|0.01|TWO_SIDED|95.0|1.76|14.14|||Chi-squared|||Null hypothesis: there is no difference between the control group and experimental group in terms of frequency of leucopenia.(α=0.05） Chi-square test was applied to test the difference. The Chi-square value was 10.08 and the P-value was 0.0015, which indicated that the null hypothesis could be rejected.||14.14|1.76|<0.01
72338182|NCT01689350|144200158|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.69|||<|0.05|TWO_SIDED|95.0|1.01|7.13|||Chi-squared|||||7.13|1.01|<0.05
72338183|NCT03688555|144200166|SUPERIORITY||LS means difference|0.76|STANDARD_ERROR_OF_MEAN|0.301|=|0.062|TWO_SIDED|95.0|-0.06|1.59||All Nasal Polyp Score (NPS) values observed between baseline and Week 12 were included in the analysis. Changes from baseline to post-baseline visits in NPS were analyzed using a Mixed Model for Repeated Measurement (MMRM).|Mixed model for repeated measurements|||||1.59|-0.06|= 0.062
72338184|NCT03688555|144200167|SUPERIORITY||LS means difference|-3.98|STANDARD_ERROR_OF_MEAN|2.316|=|0.161|TWO_SIDED|95.0|-10.41|2.45|||ANCOVA|||||2.45|-10.41|= 0.161
72338185|NCT01294462|144200178|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.54|||||TWO_SIDED|95.0|0.94|2.53||No P-value provided since the objective was not to perform formal statistical comparison.|Regression, Cox|Analyzed based on proportional hazards model including treatment group only.|Ticagrelor/Placebo|No formal statistical comparison.||2.53|0.94|
72338186|NCT01294462|144200179|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.47|||||TWO_SIDED|95.0|0.88|2.44||No P-value provided since the objective was not to perform formal statistical comparison.|Regression, Cox|Analyzed based on proportional hazards model including treatment group only.|Ticagrelor/Placebo|No formal statistical comparison based on hypothesis test.||2.44|0.88|
72338187|NCT01294462|144200180|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.72|||||TWO_SIDED|95.0|1.23|2.4||No P-value provided since the objective was not to perform formal statistical comparison.|Regression, Cox|Analyzed based on proportional hazards model including treatment group only.|Ticagrelor/Placebo|No formal statistical comparison.||2.40|1.23|
72338188|NCT01294462|144200181|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.51|||||TWO_SIDED|95.0|0.91|2.5||No P-value provided since the objective was not to perform formal statistical comparison.|Regression, Cox|Analyzed based on proportional hazards model including treatment group only.|Ticagrelor/Placebo|No formal statistical comparison based on hypothesis test.||2.50|0.91|
72338189|NCT02076399|144200182|SUPERIORITY||Risk Difference (RD)|17.6||||0.0261|TWO_SIDED|95.0|7.2|28.1|||Fisher Exact|||||28.1|7.2|0.0261
72338190|NCT02076399|144200187|SUPERIORITY||Risk Difference (RD)|-0.01||||0.6642|TWO_SIDED|95.0|-0.01|0.0||P-value from a two-sided two-sample t-test, testing for a difference in means between fostamatinib and placebo.|t-test, 2 sided|||||0.0|-0.01|0.6642
72338191|NCT02076399|144200188|SUPERIORITY||Risk Difference (RD)|0.15||||0.3365|TWO_SIDED|95.0|-0.2|0.5||P-value from a two-sided two-sample t-test, testing for a difference in means between fostamatinib and placebo.|t-test, 2 sided|||||0.5|-0.2|0.3365
72338192|NCT00085254|144200191|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.83||||0.4|TWO_SIDED|95.0|0.5|1.3|||Regression, Cox|||||1.3|0.5|0.4
72338193|NCT00085254|144200193|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.39||||0.0001|TWO_SIDED|95.0|0.3|0.5||adjusted for age: p=.0003, kps: p=.004; and surgical procedure: p=.003|Log Rank|||Primary endpoint death - defined from histological diagnosis to death. we assume pt in the study will have overall failure rate of 0.56 per person-year of f/up, a 30% reduction compared to hazard rate of 0.8 per person-year in historical NABTT database. Expected hazard ratio is 0.7 and cohort will produce 63 events among total of 94 pt planned f/up. One-sided test, have 95% power to detect observed ratio of 0.7 at alpha level of 0.1, or we have 88% power at alpha of 0.5 statistical significant||0.5|0.3|0.0001
72338194|NCT04342689|144200194|SUPERIORITY|||||||0.99|||||||Chi-squared|||||||0.99
72338195|NCT04342689|144200195|SUPERIORITY|||||||0.52|||||||t-test, 2 sided|||||||0.52
72338196|NCT04342689|144200196|SUPERIORITY|||||||0.24|||||||t-test, 2 sided|||||||0.24
72338197|NCT01460407|144200197|SUPERIORITY_OR_OTHER||Ratio of geometric LS mean|1.28|||||TWO_SIDED|90.0|1.16|1.42|||||Ratio of LY2216684 and Clarithromycin to LY2216684|||1.42|1.16|
72338198|NCT01460407|144200198|SUPERIORITY_OR_OTHER||Ratio of geometric LS mean|1.21|||||TWO_SIDED|90.0|1.12|1.31|||||Ratio of LY2216684 and Clarithromycin to LY2216684|||1.31|1.12|
72338199|NCT01460407|144200199|SUPERIORITY_OR_OTHER||Median of paired differences|0.0||||0.7656|TWO_SIDED|90.0|-0.5|0.5|||Wilcoxon (Mann-Whitney)||LY2216684 and Clarithromycin minus (-) LY2216684|||0.50|-0.50|0.7656
72338200|NCT00844805|144200219|SUPERIORITY_OR_OTHER||Difference in Percentages|14.9|||=|0.0884|TWO_SIDED|95.0|-1.7|31.5|||Fisher Exact||The 95% CI for treatment differences were computed using Wilson's Method.|||31.5|-1.7|=0.0884
72338201|NCT00844805|144200220|SUPERIORITY_OR_OTHER||Difference in Percentages|21.7|||=|0.0013|TWO_SIDED|95.0|11.0|32.5|||Fisher Exact||The 95% CI for treatment differences were computed using Wilson's Method.|||32.5|11.0|=0.0013
72338202|NCT00844805|144200221|SUPERIORITY_OR_OTHER||Difference in Percentages|18.1|||=|0.0004|TWO_SIDED|95.0|10.7|25.5|||Fisher Exact||The 95% CI for treatment differences were computed using Wilson's Method.|||25.5|10.7|=0.0004
72428108|NCT02564055|144367358|OTHER||Difference in percentages|24.2|||||TWO_SIDED|95.0|-40.3|80.9|||||Difference between GSK2894512 0.5 % QD and Vehicle QD at EW has been presented.|||80.9|-40.3|
72338203|NCT00844805|144200222|SUPERIORITY_OR_OTHER||Difference in Percentages|10.0|||=|0.5005|TWO_SIDED|95.0|-11.7|31.7|||Fisher Exact||The 95% CI for treatment differences were computed using Wilson's Method.|||31.7|-11.7|=0.5005
72338204|NCT00844805|144200223|SUPERIORITY_OR_OTHER||Difference in Percentages|-2.5|||=|1|TWO_SIDED|95.0|-14.9|9.9|||Fisher Exact||The 95% CI for treatment differences were computed using Wilson's Method.|||9.9|-14.9|=1.0000
72338205|NCT00844805|144200224|SUPERIORITY_OR_OTHER||Difference in Percentages|0.0|||=|1|TWO_SIDED|95.0|-6.8|6.8|||Fisher Exact||The 95% CI for treatment differences were computed using Wilson's Method.|||6.8|-6.8|=1.0000
72338206|NCT00844805|144200225|SUPERIORITY_OR_OTHER||||||=|0.3802||95.0|||||Log Rank|||||||=0.3802
72338207|NCT00844805|144200226|SUPERIORITY_OR_OTHER||Difference in Percentages|-5.0|||=|0.6153|TWO_SIDED|95.0|-14.5|4.5|||Fisher Exact||The 95% CI for treatment differences were computed using Wilson's Method.|||4.5|-14.5|=0.6153
72338208|NCT00844805|144200227|SUPERIORITY_OR_OTHER||Difference in Percentages|18.4|||=|0.0263|TWO_SIDED|95.0|2.5|34.3|||Fisher Exact||The 95% CI for treatment differences were computed using Wilson's Method.|||34.3|2.5|=0.0263
72338209|NCT00844805|144200228|SUPERIORITY_OR_OTHER||Difference in Percentages|8.4|||=|0.3011|TWO_SIDED|95.0|-6.0|22.8|||Fisher Exact||The 95% CI for treatment differences were computed using Wilson's Method.|||22.8|-6.0|=0.3011
72338210|NCT01741532|144200267|SUPERIORITY|||||||0.0761|||||||Mixed Models Analysis|||||||0.0761
72338211|NCT01741532|144200268|SUPERIORITY|||||||0.7279|||||||Mixed Models Analysis|||||||0.7279
72338212|NCT01741532|144200269|SUPERIORITY|||||||0.7228|||||||Mixed Models Analysis|||Comparison of treatment groups on change in score on UPDRS Part I||||0.7228
72338213|NCT01741532|144200269|SUPERIORITY|||||||0.3677|||||||Mixed Models Analysis|||Comparison of treatment groups on change in score on UPDRS Part II||||0.3677
72338214|NCT01741532|144200269|SUPERIORITY|||||||0.2182|||||||Mixed Models Analysis|||Comparison of treatment groups on change in score on UPDRS Part III||||0.2182
72338215|NCT01741532|144200269|SUPERIORITY|||||||0.1749|||||||Mixed Models Analysis|||Comparison of treatment groups on change in score on UPDRS Part VI||||0.1749
72338216|NCT01741532|144200270|SUPERIORITY|||||||0.1524|||||||Mixed Models Analysis|||||||0.1524
72338217|NCT01741532|144200271|SUPERIORITY|||||||0.2026|||||||Mixed Models Analysis|||||||0.2026
72338218|NCT01741532|144200272|SUPERIORITY|||||||0.9759|||||||Mixed Models Analysis|||Patient self-report, total score||||0.9759
72338219|NCT01741532|144200272|SUPERIORITY|||||||0.5781|||||||Mixed Models Analysis|||Parent proxy-report, total score||||0.5781
72338220|NCT01741532|144200273|SUPERIORITY|||||||0.6323|||||||Mixed Models Analysis|||||||0.6323
72338221|NCT01741532|144200274|SUPERIORITY|||||||0|||||||Mixed Models Analysis|||||||0.0000
72338222|NCT00946322|144200288|SUPERIORITY_OR_OTHER|||||||0.028|TWO_SIDED||||||t-test, 2 sided|||Paired sample t-test||||.028
72338223|NCT00946322|144200289|SUPERIORITY_OR_OTHER|||||||0.022|TWO_SIDED||||||t-test, 2 sided|||Paired sample t-tests were used. Due to variable skewness, variables were logarithm-transformed to improve their distributions.||||.022
72338224|NCT00946322|144200290|SUPERIORITY_OR_OTHER|||||||0.043|TWO_SIDED||||||t-test, 2 sided|||Paired sample t-test||||.043
72338225|NCT00946322|144200291|SUPERIORITY_OR_OTHER|||||||0.482|TWO_SIDED||||||t-test, 2 sided|||Paired sample t-test||||.482
72338226|NCT00946322|144200292|SUPERIORITY_OR_OTHER|||||||0.009|TWO_SIDED||||||t-test, 2 sided|||Paired sample t-test||||.009
72338227|NCT00946322|144200293|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED||||||t-test, 2 sided|||Paired sample t-test||||.001
72338228|NCT00946322|144200294|SUPERIORITY_OR_OTHER|||||||0.027|TWO_SIDED||||||t-test, 2 sided|||Paired sample t-test||||.027
72338229|NCT00946322|144200295|SUPERIORITY_OR_OTHER|||||||0.177|TWO_SIDED||||||t-test, 2 sided|||Paired sample t-test||||.177
72338230|NCT01822535|144200300|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||ANOVA|||Between-group differences in percent changes in core body temperature from baseline values to after cool exposure were analyzed. Because individuals with tetraplegia have impaired thermoregulatory mechanisms, we hypothesized that their percent change in core body temperature would be significantly larger than that of able-bodied controls.||||<0.01
72338231|NCT01822535|144200301|SUPERIORITY_OR_OTHER|||||||0.018|TWO_SIDED||||||ANOVA|||"Between-group comparisons of percent changes in Stroop Interference T-scores from baseline values to after cool exposure were analyzed.~We hypothesized that subjects with tetraplegia would have greater declines in cognitive performance after cool exposure than able-bodied controls."||||0.018
72338232|NCT01822535|144200302|SUPERIORITY_OR_OTHER|||||||0.0431|TWO_SIDED||||||ANOVA|||"Between-group comparisons of percent changes in Delayed Recall from baseline values to after cool exposure were analyzed.~We hypothesized that subjects with tetraplegia would have greater declines in cognitive performance after cool exposure than able-bodied controls."||||0.0431
72338233|NCT01822535|144200303|SUPERIORITY_OR_OTHER|||||||0.3|TWO_SIDED||||||ANOVA|||"We hypothesized that administration of midodrine would attenuate the fall in core body temperature.~Within-group percent changes in core body temperature were analyzed to compare data from visit 1 (no drug) to visit 2 (drug)."||||0.30
72338234|NCT02278614|144200304|OTHER|The change from baseline in mean IOP on Day 84 for the contralateral eye,|Adjusted mean difference|-0.07|STANDARD_ERROR_OF_MEAN|0.26|||TWO_SIDED|95.0|-0.57|0.43|||Mixed Models Analysis|||||0.43|-0.57|
72338235|NCT02278614|144200304|OTHER|The change from baseline in mean IOP on D42 for the worse eye|Adjusted mean difference|-0.19|STANDARD_ERROR_OF_MEAN|0.25|||TWO_SIDED|95.0|-0.69|0.31|||Mixed Models Analysis|||||0.31|-0.69|
72338236|NCT03582813|144200319|SUPERIORITY||MIXREG Estimate|4.27|STANDARD_ERROR_OF_MEAN|1.61|<|0.01|TWO_SIDED||||||Mixed Effects Random Regression|||This mixed effects random regression analysis tested whether intervention participants would report larger increases than controls in self-perceived Recovery and that this effect would be maintained overtime;||||<.01
72338237|NCT03582813|144200320|SUPERIORITY||MIXREG Estimate|0.9|STANDARD_ERROR_OF_MEAN|0.42||0.031|TWO_SIDED||||||Mixed Effects Random Regression|||This mixed effects random regression analysis tested whether intervention participants would report larger increases than controls in self-esteem that would be maintained longitudinally||||.031
72338238|NCT03582813|144200321|SUPERIORITY||MIXREG Estimate|0.12|STANDARD_ERROR_OF_MEAN|0.04|<|0.01|TWO_SIDED||||||Mixed Effects Random Regression|||This mixed effects random regression analysis tested whether intervention participants would report larger increases than controls in coping mastery that would be maintained longitudinally||||<0.01
72428109|NCT02564055|144367359|OTHER||Difference in percentages|5.3|||||TWO_SIDED|95.0|-18.3|28.4|||||Difference between GSK2894512 1 % BID and Vehicle BID at Week 1 has been presented.|||28.4|-18.3|
72428110|NCT02564055|144367359|OTHER||Difference in percentages|5.9|||||TWO_SIDED|95.0|-17.1|28.4|||||Difference between GSK2894512 1 % QD and Vehicle QD at Week 1 has been presented.|||28.4|-17.1|
72428111|NCT02564055|144367359|OTHER||Difference in percentages|-0.8|||||TWO_SIDED|95.0|-24.0|22.7|||||Difference between GSK2894512 0.5 % QD and Vehicle QD at Week 1 has been presented.|||22.7|-24.0|
72428112|NCT02564055|144367359|OTHER||Difference in percentages|11.4|||||TWO_SIDED|95.0|-12.0|33.9|||||Difference between GSK2894512 1 % BID and Vehicle BID at Week 2 has been presented.|||33.9|-12.0|
72428113|NCT02564055|144367359|OTHER||Difference in percentages|30.2|||||TWO_SIDED|95.0|6.8|51.0|||||Difference between GSK2894512 1 % QD and Vehicle QD at Week 2 has been presented.|||51.0|6.8|
72428114|NCT02564055|144367359|OTHER||Difference in percentages|3.7|||||TWO_SIDED|95.0|-19.4|26.6|||||Difference between GSK2894512 0.5 % BID and Vehicle BID at Week 2 has been presented.|||26.6|-19.4|
72428115|NCT02564055|144367359|OTHER||Difference in percentages|17.4|||||TWO_SIDED|95.0|-6.0|39.5|||||Difference between GSK2894512 0.5 % QD and Vehicle QD at Week 2 has been presented.|||39.5|-6.0|
72428116|NCT02564055|144367359|OTHER||Difference in percentages|16.8|||||TWO_SIDED|95.0|-7.1|39.4|||||Difference between GSK2894512 1 % BID and Vehicle BID at Week 4 has been presented.|||39.4|-7.1|
72428117|NCT02564055|144367359|OTHER||Difference in percentages|41.9|||||TWO_SIDED|95.0|19.2|61.2|||||Difference between GSK2894512 1 % QD and Vehicle QD at Week 4 has been presented.|||61.2|19.2|
72338239|NCT03582813|144200322|SUPERIORITY||MIXREG Estimate|0.29|STANDARD_ERROR_OF_MEAN|0.13||0.03|TWO_SIDED||||||Mixed Effects Random Regression|||This mixed effects random regression analysis tested whether intervention participants would report larger increases than controls in perceived autonomy support that would be maintained longitudinally||||0.030
72428118|NCT02564055|144367359|OTHER||Difference in percentages|8.9|||||TWO_SIDED|95.0|-14.9|32.0|||||Difference between GSK2894512 0.5 % BID and Vehicle BID at Week 4 has been presented.|||32.0|-14.9|
72428119|NCT02564055|144367359|OTHER||Difference in percentages|16.3|||||TWO_SIDED|95.0|-7.3|38.3|||||Difference between GSK2894512 0.5 % QD and Vehicle QD at Week 4 has been presented.|||38.3|-7.3|
72338240|NCT03582813|144200323|SUPERIORITY||Odds Ratio (OR)|2.19||||0.046|TWO_SIDED|95.0|1.01|4.74|||Regression, Logistic|||This mixed effects random regression analysis tested whether intervention participants would report greater likelihood of employment that would be maintained longitudinally||4.74|1.01|0.046
72338241|NCT03582813|144200324|SUPERIORITY||Odds Ratio (OR)|4.14|||<|0.01|TWO_SIDED|95.0|1.5|11.44|||Regression, Logistic|||This mixed effects random regression analysis tested whether intervention participants would report greater likelihood of enrollment in educational classes that would be maintained longitudinally||11.44|1.50|<0.01
72338242|NCT02558400|144200334|SUPERIORITY|To claim superiority PG324 had to be statistically superior to netarsudil and to latanoprost at all 9 of 9 primary efficacy timepoints|||||<|0.0001|||||||t-test, 2 sided|PG324 vs. netarsudil||||||<0.0001
72338243|NCT02558400|144200334|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|PG324 vs. latanoprost||||||<0.0001
72428120|NCT02564055|144367359|OTHER||Difference in percentages|13.4|||||TWO_SIDED|95.0|-11.3|36.5|||||Difference between GSK2894512 1 % BID and Vehicle BID at Week 8 has been presented.|||36.5|-11.3|
72428121|NCT02564055|144367359|OTHER||Difference in percentages|30.8|||||TWO_SIDED|95.0|6.1|52.8|||||Difference between GSK2894512 1 % QD and Vehicle QD at Week 8 has been presented.|||52.8|6.1|
72428122|NCT02564055|144367359|OTHER||Difference in percentages|21.9|||||TWO_SIDED|95.0|-3.0|44.9|||||Difference between GSK2894512 0.5 % BID and Vehicle BID at Week 8 has been presented.|||44.9|-3.0|
72428123|NCT02564055|144367359|OTHER||Difference in percentages|10.9|||||TWO_SIDED|95.0|-13.5|34.7|||||Difference between GSK2894512 0.5 % QD and Vehicle QD at Week 8 has been presented.|||34.7|-13.5|
72428124|NCT02564055|144367359|OTHER||Difference in percentages|27.4|||||TWO_SIDED|95.0|2.5|49.9|||||Difference between GSK2894512 1 % BID and Vehicle BID at Week 12 has been presented.|||49.9|2.5|
72428125|NCT02564055|144367359|OTHER||Difference in percentages|16.8|||||TWO_SIDED|95.0|-9.0|40.7|||||Difference between GSK2894512 1 % QD and Vehicle QD at Week 12 has been presented.|||40.7|-9.0|
72428126|NCT02564055|144367359|OTHER||Difference in percentages|29.5|||||TWO_SIDED|95.0|3.7|52.3|||||Difference between GSK2894512 0.5 % BID and Vehicle BID at Week 12 has been presented.|||52.3|3.7|
72428127|NCT02564055|144367359|OTHER||Difference in percentages|5.7|||||TWO_SIDED|95.0|-20.1|30.9|||||Difference between GSK2894512 0.5 % QD and Vehicle QD at Week 12 has been presented.|||30.9|-20.1|
72428128|NCT02564055|144367359|OTHER||Difference in percentages|9.3|||||TWO_SIDED|95.0|-16.2|33.8|||||Difference between GSK2894512 1 % BID and Vehicle BID at Week 14 has been presented.|||33.8|-16.2|
72428129|NCT02564055|144367359|OTHER||Difference in percentages|12.6|||||TWO_SIDED|95.0|-13.4|37.3|||||Difference between GSK2894512 1 % QD and Vehicle QD at Week 14 has been presented.|||37.3|-13.4|
72428130|NCT02564055|144367359|OTHER||Difference in percentages|27.0|||||TWO_SIDED|95.0|0.7|50.5|||||Difference between GSK2894512 0.5 % BID and Vehicle BID at Week 14 has been presented.|||50.5|0.7|
72428131|NCT02564055|144367359|OTHER||Difference in percentages|0.4|||||TWO_SIDED|95.0|-25.6|25.6|||||Difference between GSK2894512 0.5 % QD and Vehicle QD at Week 14 has been presented.|||25.6|-25.6|
72428132|NCT02564055|144367359|OTHER||Difference in percentages|2.6|||||TWO_SIDED|95.0|-22.6|27.6|||||Difference between GSK2894512 1 % BID and Vehicle BID at Week 16 has been presented.|||27.6|-22.6|
72428133|NCT02564055|144367359|OTHER||Difference in percentages|6.9|||||TWO_SIDED|95.0|-18.7|31.7|||||Difference between GSK2894512 1 % QD and Vehicle QD at Week 16 has been presented.|||31.7|-18.7|
72428134|NCT02564055|144367359|OTHER||Difference in percentages|16.8|||||TWO_SIDED|95.0|-9.5|41.4|||||Difference between GSK2894512 0.5 % BID and Vehicle BID at Week 16 has been presented.|||41.4|-9.5|
72428135|NCT02564055|144367359|OTHER||Difference in percentages|10.9|||||TWO_SIDED|95.0|-14.9|35.8|||||Difference between GSK2894512 0.5 % QD and Vehicle QD at Week 16 has been presented.|||35.8|-14.9|
72428136|NCT02564055|144367359|OTHER||Difference in percentages|33.3|||||TWO_SIDED|95.0|-31.9|90.6|||||Difference between GSK2894512 1 % BID and Vehicle BID at EW has been presented.|||90.6|-31.9|
72428137|NCT02564055|144367359|OTHER||Difference in percentages|-9.1|||||TWO_SIDED|95.0|-62.4|47.8|||||Difference between GSK2894512 1 % QD and Vehicle QD at EW has been presented.|||47.8|-62.4|
72428138|NCT02564055|144367359|OTHER||Difference in percentages|14.3|||||TWO_SIDED|95.0|-32.2|57.9|||||Difference between GSK2894512 0.5 % BID and Vehicle BID at EW has been presented.|||57.9|-32.2|
72338244|NCT02230683|144200336|SUPERIORITY_OR_OTHER||within group change|-1.14|STANDARD_DEVIATION|4.57||0.257|TWO_SIDED|95.0|-3.16|0.89|||Paired t-test||within group change|Statistical Analysis for the mean change of the Hepatic Venous Pressure Gradient from Baseline to Day 28/EOT for the overall evaluable population treated with IDN-6556 25 mg twice daily||0.89|-3.16|0.257
72338245|NCT02230683|144200336|SUPERIORITY_OR_OTHER||within group change|1.9|STANDARD_DEVIATION|3.15||0.1174|TWO_SIDED|95.0|-0.52|4.32|||ANCOVA||within group change|Statistical Analysis for the mean change of the Hepatic Venous Pressure Gradient from Baseline to Day 28/EOT in the HVPG \< 12 mmHg subgroup||4.32|-0.52|0.1174
72338246|NCT02230683|144200336|SUPERIORITY_OR_OTHER||within group change|-3.67|STANDARD_DEVIATION|4.05||0.0025|TWO_SIDED|95.0|-5.88|-1.46|||ANCOVA||within group change|Statistical Analysis for the mean change of the Hepatic Venous Pressure Gradient from Baseline to Day 28/EOT in the HVPG ≥ 12 mmHg subgroup||-1.46|-5.88|0.0025
72338247|NCT02230683|144200337|SUPERIORITY_OR_OTHER||within group change|-0.22||||0.026|TWO_SIDED|95.0|-0.42|-0.03|||ANCOVA|||Statistical Analysis for the mean change in log-transformed caspase-cleaved cytokeratin serum levels from Baseline to Day 28/EOT for the overall evaluable population treated with IDN-6556 25 mg twice daily||-0.03|-0.42|0.026
72338248|NCT02230683|144200337|SUPERIORITY_OR_OTHER||within group change|-0.46||||0.001|TWO_SIDED|95.0|-0.72|-0.21|||ANCOVA|||Statistical Analysis for the mean change in log-transformed caspase-cleaved cytokeratin serum levels from Baseline to Day 28/EOT in the HVPG \< 12 mmHg subgroup population treated with IDN-6556 25 mg twice daily||-0.21|-0.72|0.001
72338249|NCT02230683|144200337|SUPERIORITY_OR_OTHER||within group change|-0.04||||0.72|TWO_SIDED|95.0|-0.26|0.18|||ANCOVA|||Statistical Analysis for the median change in log-transformed caspase-cleaved cytokeratin serum levels from Baseline to Day 28/EOT in the HVPG ≥ 12 mmHg subgroup population treated with IDN-6556 25 mg twice daily||0.18|-0.26|0.72
72338250|NCT02230683|144200338|SUPERIORITY_OR_OTHER||Hodges-Lehmann|-21.0||||0.105|TWO_SIDED|95.0|-60.0|13.0|||Wilcoxon (Mann-Whitney)|||Statistical Analysis for the median change of caspase-cleaved cytokeratin serum levels from Baseline to Day 28/EOT for the overall evaluable population treated with IDN-6556 25 mg twice daily||13|-60|0.105
72338251|NCT02230683|144200338|SUPERIORITY_OR_OTHER||Hodges-Lehmann|-52.5||||0.016|TWO_SIDED|95.0|-109.0|-6.0|||Wilcoxon (Mann-Whitney)|||Statistical Analysis for the median change of caspase-cleaved cytokeratin serum levels from Baseline to Day 28/EOT in the HVPG \< 12 mmHg subgroup population treated with IDN-6556 25 mg twice daily||-6|-109|0.016
72338252|NCT02230683|144200338|SUPERIORITY_OR_OTHER||Hodges-Lehmann|12.0||||0.839|TWO_SIDED|95.0|-60.0|13.0|||Wilcoxon (Mann-Whitney)|||Statistical Analysis for the median change of caspase-cleaved cytokeratin serum levels from Baseline to Day 28/EOT in the HVPG ≥ 12 mmHg subgroup population treated with IDN-6556 25 mg twice daily||13|-60|0.839
72338253|NCT02230683|144200339|SUPERIORITY_OR_OTHER||Hodges-Lehmann|-4.0||||0.0084|TWO_SIDED|95.0|-7.0|0.0|||Wilcoxon (Mann-Whitney)|||Statistical Analysis for the median change in Alanine Aminotransferase (ALT) from Baseline to Day 28/EOT||0|-7|0.0084
72338254|NCT02230683|144200340|SUPERIORITY_OR_OTHER||Hodges-Lehmann|-4.0||||0.0131|TWO_SIDED|95.0|-7.0|-1.0|||Wilcoxon (Mann-Whitney)|||Statistical Analysis for the median change in Aspartate Aminotransferase (AST) from Baseline to Day 28/EOT||-1|-7|0.0131
72338255|NCT02230683|144200341|SUPERIORITY_OR_OTHER||Hodges-Lehmann|-772.0||||0.003|TWO_SIDED|95.0|-1188.0|-19.0|||Wilcoxon (Mann-Whitney)||The estimated value is the ratio for the difference from baseline.|Statistical Analysis for the median change in concentration of Caspase 3/7 Relative Light Units from baseline to Day 28/EOT||-19|-1188|0.003
72338256|NCT00260065|144200342|SUPERIORITY_OR_OTHER||Percentage of Participants|33.0||||||95.0|24.2|43.5||||||||43.5|24.2|
72338257|NCT00260065|144200343|SUPERIORITY_OR_OTHER||Percentage of Participants|52.0||||||95.0|41.3|61.7||||||||61.7|41.3|
72338258|NCT03654885|144200375|NON_INFERIORITY|By assuming the margin of non-inferiority at 24%, the null hypothesis for this non-inferiority testing was to be set up as XEN implanted group (P1)-Trabeculectomy group (P2) ≤-0.24 versus the alternative hypothesis as P1-P2 \>-0.24. Equivalently, non-inferiority of P1 to P2 was to be declared if the lower limit of the 2-sided confidence interval (CI) of the difference of the above endpoint between the two treatment groups computed using normal approximation was found to be greater than -24%.|Percentage Difference|-6.1||||0.487|TWO_SIDED|95.0|-22.9|10.8|||Chi-squared|||||10.8|-22.9|0.487
72338259|NCT03654885|144200377|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Percentage Difference|-5.81|STANDARD_ERROR_OF_MEAN|1.155|<|0.001|TWO_SIDED|95.0|-8.074|-3.538||Mixed Model for Repeated Measures (MMRM) model with treatment and time as the factors, treatment by time interaction and Baseline as the covariate variables were used for analysis.|Mixed Model for Repeated Measures|||Change From Baseline in Mean IOP Over Time: Day 1||-3.538|-8.074|<0.001
72338260|NCT03654885|144200377|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Percentage Difference|-0.22|STANDARD_ERROR_OF_MEAN|1.163||0.851|TWO_SIDED|95.0|-2.503|2.066||MMRM model with treatment and time as the factors, treatment by time interaction and Baseline as the covariate variables were used for analysis.|Mixed Model for Repeated Measures|||Change From Baseline in Mean IOP Over Time: Week 1||2.066|-2.503|0.851
72338261|NCT03654885|144200377|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Percentage Difference|2.03|STANDARD_ERROR_OF_MEAN|1.162||0.081|TWO_SIDED|95.0|-0.253|4.309||MMRM model with treatment and time as the factors, treatment by time interaction and Baseline as the covariate variables were used for analysis.|Mixed Model for Repeated Measures|||Change From Baseline in Mean IOP Over Time: Week 2||4.309|-0.253|0.081
72338262|NCT03654885|144200377|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Percentage Difference|2.21|STANDARD_ERROR_OF_MEAN|1.157||0.056|TWO_SIDED|95.0|-0.059|4.484||MMRM model with treatment and time as the factors, treatment by time interaction and Baseline as the covariate variables were used for analysis.|Mixed Model for Repeated Measures|||Change From Baseline in Mean IOP Over Time: Month 1||4.484|-0.059|0.056
72338263|NCT03654885|144200377|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Percentage Difference|4.74|STANDARD_ERROR_OF_MEAN|1.181|<|0.001|TWO_SIDED|95.0|2.416|7.054||MMRM model with treatment and time as the factors, treatment by time interaction and Baseline as the covariate variables were used for analysis.|Mixed Model for Repeated Measures|||Change From Baseline in Mean IOP Over Time: Month 3||7.054|2.416|<0.001
72428139|NCT02564055|144367359|OTHER||Difference in percentages|24.2|||||TWO_SIDED|95.0|-40.3|80.9|||||Difference between GSK2894512 0.5 % QD and Vehicle QD at EW has been presented.|||80.9|-40.3|
72338264|NCT03654885|144200377|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Percentage Difference|3.01|STANDARD_ERROR_OF_MEAN|1.197||0.012|TWO_SIDED|95.0|0.657|5.358||MMRM model with treatment and time as the factors, treatment by time interaction and Baseline as the covariate variables were used for analysis.|Mixed Model for Repeated Measures|||Change From Baseline in Mean IOP Over Time: Month 6||5.358|0.657|0.012
72338265|NCT03654885|144200377|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Percentage Difference|3.53|STANDARD_ERROR_OF_MEAN|1.197||0.003|TWO_SIDED|95.0|1.182|5.883||MMRM model with treatment and time as the factors, treatment by time interaction and Baseline as the covariate variables were used for analysis.|Mixed Model for Repeated Measures|||Change From Baseline in Mean IOP Over Time: Month 9||5.883|1.182|0.003
72338266|NCT03654885|144200377|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Percentage Difference|2.77|STANDARD_ERROR_OF_MEAN|1.229||0.024|TWO_SIDED|95.0|0.358|5.183||MMRM model with treatment and time as the factors, treatment by time interaction and Baseline as the covariate variables were used for analysis.|Mixed Model for Repeated Measures|||Change From Baseline in Mean IOP Over Time: Month 12||5.183|0.358|0.024
72338267|NCT03654885|144200379|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Percentage Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.14||0.505|TWO_SIDED|95.0|-0.36|0.18||MMRM model with treatment and time as the factors, treatment by time interaction and baseline as the covariate variables were used for analysis.|Mixed Model for Repeated Measures|||Change from Baseline in Mean Number of Topical IOP-Lowering Medications Over Time: Day 1||0.18|-0.36|0.505
72338268|NCT03654885|144200379|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Percentage Difference|0.0|STANDARD_ERROR_OF_MEAN|0.14||0.949|TWO_SIDED|95.0|-0.28|0.26||MMRM model with treatment and time as the factors, treatment by time interaction and baseline as the covariate variables were used for analysis.|Mixed Model for Repeated Measures|||Change from Baseline in Mean Number of Topical IOP-Lowering Medications Over Time: Week 1||0.26|-0.28|0.949
72338269|NCT03654885|144200379|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Percentage Difference|0.1|STANDARD_ERROR_OF_MEAN|0.14||0.581|TWO_SIDED|95.0|-0.19|0.34||MMRM model with treatment and time as the factors, treatment by time interaction and baseline as the covariate variables were used for analysis.|Mixed Model for Repeated Measures|||Change from Baseline in Mean Number of Topical IOP-Lowering Medications Over Time: Week 2||0.34|-0.19|0.581
72338270|NCT03654885|144200379|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Percentage Difference|0.1|STANDARD_ERROR_OF_MEAN|0.14||0.302|TWO_SIDED|95.0|-0.13|0.41||MMRM model with treatment and time as the factors, treatment by time interaction and baseline as the covariate variables were used for analysis.|Mixed Model for Repeated Measures|||Change from Baseline in Mean Number of Topical IOP-Lowering Medications Over Time: Month 1||0.41|-0.13|0.302
72338271|NCT03654885|144200379|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Percentage Difference|0.4|STANDARD_ERROR_OF_MEAN|0.14||0.005|TWO_SIDED|95.0|0.12|0.66||MMRM model with treatment and time as the factors, treatment by time interaction and baseline as the covariate variables were used for analysis.|Mixed Model for Repeated Measures|||Change from Baseline in Mean Number of Topical IOP-Lowering Medications Over Time: Month 3||0.66|0.12|0.005
72338272|NCT03654885|144200379|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Percentage Difference|0.3|STANDARD_ERROR_OF_MEAN|0.14||0.026|TWO_SIDED|95.0|0.04|0.59||MMRM model with treatment and time as the factors, treatment by time interaction and baseline as the covariate variables were used for analysis.|Mixed Model for Repeated Measures|||Change from Baseline in Mean Number of Topical IOP-Lowering Medications Over Time: Month 6||0.59|0.04|0.026
72338273|NCT03654885|144200379|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Percentage Difference|0.4|STANDARD_ERROR_OF_MEAN|0.14||0.01|TWO_SIDED|95.0|0.09|0.64||MMRM model with treatment and time as the factors, treatment by time interaction and baseline as the covariate variables were used for analysis.|Mixed Model for Repeated Measures|||Change from Baseline in Mean Number of Topical IOP-Lowering Medications Over Time: Month 9||0.64|0.09|0.010
72338274|NCT03654885|144200379|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Percentage Difference|0.3|STANDARD_ERROR_OF_MEAN|0.14||0.052|TWO_SIDED|95.0|0.0|0.54||MMRM model with treatment and time as the factors, treatment by time interaction and baseline as the covariate variables were used for analysis.|Mixed Model for Repeated Measures|||Change from Baseline in Mean Number of Topical IOP-Lowering Medications Over Time: Month 12||0.54|0.00|0.052
72338275|NCT03654885|144200380|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Least Square Mean Difference|2.77|STANDARD_ERROR_OF_MEAN|1.229||0.024|TWO_SIDED|95.0|0.358|5.183||MMRM model with treatment and time as the factors, treatment by time interaction and baseline as the covariate variables was used for analysis.|Mixed Model for Repeated Measures|||||5.183|0.358|0.024
72338276|NCT03654885|144200381|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Least Square Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|0.14||0.052|TWO_SIDED|95.0|0.0|0.54||MMRM model with treatment and time as the factors, treatment by time interaction and baseline as the covariate variables was used for analysis.|Mixed Model for Repeated Measures|||||0.54|0.00|0.052
72338277|NCT03654885|144200382|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Least Square Mean Difference|1.79|STANDARD_ERROR_OF_MEAN|2.214||0.421|TWO_SIDED|95.0|-2.579|6.151||MMRM model with treatment and time as the factors, treatment by time interaction and baseline as the covariate variables was used for analysis.|Mixed model repeated measures|||||6.151|-2.579|0.421
72428140|NCT02564055|144367366|OTHER||Difference in percentages|-7.7|||||TWO_SIDED|95.0|-45.8|32.5|||||Difference between GSK2894512 1 % BID and Vehicle BID at Week 1 has been presented.|||32.5|-45.8|
72428141|NCT02564055|144367366|OTHER||Difference in percentages|15.4|||||TWO_SIDED|95.0|-25.7|52.6|||||Difference between GSK2894512 1 % QD and vehicle QD at Week 1 has been presented.|||52.6|-25.7|
72428142|NCT02564055|144367366|OTHER||Difference in percentages|-7.7|||||TWO_SIDED|95.0|-46.0|32.6|||||Difference between GSK2894512 0.5 % BID and vehicle BID at Week 1 has been presented.|||32.6|-46.0|
72338278|NCT03654885|144200383|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Least Square Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|0.25||0.18|TWO_SIDED|95.0|-0.16|0.84||MMRM model with treatment and time as the factors, treatment by time interaction and baseline as the covariate variables was used for analysis.|Mixed Model for Repeated Measures|||||0.84|-0.16|0.180
72338279|NCT03654885|144200384|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Percentage Difference|-15.7||||0.064|TWO_SIDED|95.0|-33.0|2.3|||Fisher Exact|||Percentage of Participants Achieving Specific IOP Targets at Month 12: IOP Value of ≤18 mmHg||2.3|-33.0|0.064
72338280|NCT03654885|144200384|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Percentage Difference|-15.3||||0.078|TWO_SIDED|95.0|-32.7|2.5|||Fisher Exact|||Percentage of Participants Achieving Specific IOP Targets at Month 12: IOP Value of ≤17 mmHg||2.5|-32.7|0.078
72338281|NCT03654885|144200384|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Percentage Difference|-17.4||||0.051|TWO_SIDED|95.0|-34.7|0.4|||Fisher Exact|||Percentage of Participants Achieving Specific IOP Targets at Month 12: IOP Value of ≤16 mmHg||0.4|-34.7|0.051
72338282|NCT03654885|144200384|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Percentage Difference|-16.9||||0.064|TWO_SIDED|95.0|-34.1|1.0|||Fisher Exact|||Percentage of Participants Achieving Specific IOP Targets at Month 12: IOP Value of ≤15 mmHg||1.0|-34.1|0.064
72338283|NCT03654885|144200384|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Percentage Difference|-13.1||||0.2|TWO_SIDED|95.0|-30.5|4.8|||Fisher Exact|||Percentage of Participants Achieving Specific IOP Targets at Month 12: IOP Value of ≤14 mm Hg||4.8|-30.5|0.200
72338284|NCT03654885|144200384|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Percentage Difference|-20.0||||0.042|TWO_SIDED|95.0|-37.1|-2.0|||Fisher Exact|||Percentage of Participants Achieving Specific IOP Targets at Month 12: IOP Value of ≤13 mm Hg||-2.0|-37.1|0.042
72338285|NCT03654885|144200384|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Percentage Difference|-12.7||||0.18|TWO_SIDED|95.0|-30.1|5.2|||Fisher Exact|||Percentage of Participants Achieving Specific IOP Targets at Month 12: IOP Value of ≤12 mm Hg||5.2|-30.1|0.180
72338286|NCT03654885|144200385|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Percentage Difference|-3.6||||0.712|TWO_SIDED|95.0|-21.3|14.2|||Fisher Exact|||Percentage of Participants Achieving Specific Percentage IOP Lower Targets From Baseline at Month 12: ≥25% IOP Reduction||14.2|-21.3|0.712
72338287|NCT03654885|144200385|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Percentage Difference|-12.9||||0.201|TWO_SIDED|95.0|-30.3|5.0|||Fisher Exact|||Percentage of Participants Achieving Specific Percentage IOP Lower Targets From Baseline at Month 12: ≥30% IOP Reduction||5.0|-30.3|0.201
72338288|NCT03654885|144200385|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Percentage Difference|-20.3||||0.03|TWO_SIDED|95.0|-37.3|-2.3|||Fisher Exact|||Percentage of Participants Achieving Specific Percentage IOP Lower Targets From Baseline at Month 12: ≥35% IOP Reduction||-2.3|-37.3|0.030
72338289|NCT03654885|144200385|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Percentage Difference|-18.8||||0.043|TWO_SIDED|95.0|-36.0|-0.8|||Fisher Exact|||Percentage of Participants Achieving Specific Percentage IOP Lower Targets From Baseline at Month 12: ≥40% IOP Reduction||-0.8|-36.0|0.043
72428143|NCT02564055|144367366|OTHER||Difference in percentages|9.1|||||TWO_SIDED|95.0|-32.2|48.8|||||Difference between GSK2894512 0.5 % QD and vehicle QD at Week 1 has been presented.|||48.8|-32.2|
72338290|NCT03654885|144200385|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Percentage Difference|-17.9||||0.048|TWO_SIDED|95.0|-35.1|0.0|||Fisher Exact|||Percentage of Participants Achieving Specific Percentage IOP Lower Targets From Baseline at Month 12: ≥45% IOP Reduction||0.0|-35.1|0.048
72338291|NCT03654885|144200385|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Percentage Difference|-21.1||||0.015|TWO_SIDED|95.0|-38.1|-3.2|||Fisher Exact|||Percentage of Participants Achieving Specific Percentage IOP Lower Targets From Baseline at Month 12: ≥50% IOP Reduction||-3.2|-38.1|0.015
72338292|NCT03654885|144200386|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Percentage Difference|-11.7||||0.252|TWO_SIDED|95.0|-29.0|6.3|||Fisher Exact|||Percentage of Participants Achieving at Least a 20% IOP Reductions and Specific IOP Targets on Same or Lower Number of Topical IOP-Lowering Medications at Month 12- IOP Target ≤18 mm Hg||6.3|-29.0|0.252
72338293|NCT03654885|144200386|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Percentage Difference|-11.5||||0.258|TWO_SIDED|95.0|-28.9|6.5|||Fisher Exact|||Percentage of Participants Achieving at Least a 20% IOP Reductions and Specific IOP Targets on Same or Lower Number of Topical IOP-Lowering Medications at Month 12- IOP Target ≤17 mmHg||6.5|-28.9|0.258
72338294|NCT03654885|144200386|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Percentage Difference|-13.6||||0.139|TWO_SIDED|95.0|-30.9|4.4|||Fisher Exact|||Percentage of Participants Achieving at Least a 20% IOP Reductions and Specific IOP Targets on Same or Lower Number of Topical IOP-Lowering Medications at Month 12- IOP Target ≤16 mm Hg||4.4|-30.9|0.139
72338295|NCT03654885|144200386|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Percentage Difference|-14.7||||0.136|TWO_SIDED|95.0|-32.0|3.3|||Fisher Exact|||Percentage of Participants Achieving at Least a 20% IOP Reductions and Specific IOP Targets on Same or Lower Number of Topical IOP-Lowering Medications at Month 12- IOP Target ≤15 mm Hg||3.3|-32.0|0.136
72338296|NCT03654885|144200386|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.%.|Percentage Difference|-10.8||||0.274|TWO_SIDED|95.0|-28.2|7.1|||Fisher Exact|||Percentage of Participants Achieving at Least a 20% IOP Reductions and Specific IOP Targets on Same or Lower Number of Topical IOP-Lowering Medications at Month 12- IOP Target ≤14 mm Hg||7.1|-28.2|0.274
72338297|NCT03654885|144200386|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Percentage Difference|-17.7||||0.065|TWO_SIDED|95.0|-35.0|0.3|||Fisher Exact|||Percentage of Participants Achieving at Least a 20% IOP Reductions and Specific IOP Targets on Same or Lower Number of Topical IOP-Lowering Medications at Month 12- IOP Target ≤13 mm Hg||0.3|-35.0|0.065
72338298|NCT03654885|144200386|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Percentage Difference|-12.7||||0.18|TWO_SIDED|95.0|-30.1|5.2|||Fisher Exact|||Percentage of Participants Achieving at Least a 20% IOP Reductions and Specific IOP Targets on Same or Lower Number of Topical IOP-Lowering Medications at Month 12- IOP Target ≤12 mmHg||5.2|-30.1|0.180
72338299|NCT03654885|144200389|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Percentage Difference|1.8||||1|TWO_SIDED|95.0|-41.6|44.1|||Fisher Exact|||||44.1|-41.6|1.000
72338300|NCT03654885|144200390|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Percentage Difference|-32.1||||0.215|TWO_SIDED|95.0|-66.8|10.0|||Fisher Exact|||||10.0|-66.8|0.215
72338301|NCT03654885|144200392|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Percentage Difference|-14.9||||0.144|TWO_SIDED|95.0|-32.2|3.1|||Fisher Exact|||||3.1|-32.2|0.144
72338302|NCT03654885|144200393|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Percentage Difference|-10.6||||0.254|TWO_SIDED|95.0|-28.0|7.3|||Fisher Exact|||||7.3|-28.0|0.254
72338303|NCT03654885|144200394|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Percentage Difference|-7.4||||0.563|TWO_SIDED|95.0|-28.6|14.2|||Fisher Exact|||Percentage of Participants Achieving Specific IOP Targets at Month 12 in Medication-free Eye- IOP Target ≤18 mm Hg||14.2|-28.6|0.563
72338304|NCT03654885|144200394|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Percentage Difference|-12.5||||0.188|TWO_SIDED|95.0|-33.5|9.1|||Fisher Exact|||Percentage of Participants Achieving Specific IOP Targets at Month 12 in Medication-free Eye- IOP Target ≤17 mm Hg||9.1|-33.5|0.188
72338305|NCT03654885|144200394|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Percentage Difference|-15.9||||0.118|TWO_SIDED|95.0|-36.7|5.6|||Fisher Exact|||Percentage of Participants Achieving Specific IOP Targets at Month 12 in Medication-free Eye- IOP Target ≤16 mmHg||5.6|-36.7|0.118
72338306|NCT03654885|144200394|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Percentage Difference|-19.5||||0.085|TWO_SIDED|95.0|-40.2|2.1|||Fisher Exact|||Percentage of Participants Achieving Specific IOP Targets at Month 12 in Medication-free Eye- IOP Target ≤15 mm Hg||2.1|-40.2|0.085
72338307|NCT03654885|144200394|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Percentage Difference|-21.3||||0.059|TWO_SIDED|95.0|-42.0|0.4|||Fisher Exact|||Percentage of Participants Achieving Specific IOP Targets at Month 12 in Medication-free Eye- IOP Target ≤14 mm Hg||0.4|-42.0|0.059
72338308|NCT03654885|144200394|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Percentage Difference|-23.5||||0.045|TWO_SIDED|95.0|-43.9|-1.4|||Fisher Exact|||Percentage of Participants Achieving Specific IOP Targets at Month 12 in Medication-free Eye- IOP Target ≤13 mm Hg||-1.4|-43.9|0.045
72338309|NCT03654885|144200394|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Percentage Difference|-20.8||||0.076|TWO_SIDED|95.0|-41.3|1.1|||Fisher Exact|||Percentage of Participants Achieving Specific IOP Targets at Month 12 in Medication-free Eye- IOP Target ≤12 mm Hg||1.1|-41.3|0.076
72338310|NCT03654885|144200395|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Percentage Difference|-9.6||||0.464|TWO_SIDED|95.0|-31.0|12.1|||Fisher Exact|||Percentage of Participants Achieving Specific Percentage IOP Lower Targets From Baseline at Month 12 With Medication-free Eyes: ≥ 25% IOP Reduction||12.1|-31.0|0.464
72338311|NCT03654885|144200395|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Percentage Difference|-19.8||||0.069|TWO_SIDED|95.0|-40.6|2.1|||Fisher Exact|||Percentage of Participants Achieving Specific Percentage IOP Lower Targets From Baseline at Month 12 With Medication-free Eyes: ≥30% IOP Reduction||2.1|-40.6|0.069
72338312|NCT03654885|144200395|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Percentage Difference|-26.6||||0.023|TWO_SIDED|95.0|-46.9|-4.7|||Fisher Exact|||Percentage of Participants Achieving Specific Percentage IOP Lower Targets From Baseline at Month 12 With Medication-free Eyes: ≥35% IOP Reduction||-4.7|-46.9|0.023
72338313|NCT03654885|144200395|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Percentage Difference|-23.7||||0.046|TWO_SIDED|95.0|-43.9|-1.6|||Fisher Exact|||Percentage of Participants Achieving Specific Percentage IOP Lower Targets From Baseline at Month 12 With Medication-free Eyes: ≥40% IOP Reduction||-1.6|-43.9|0.046
72338314|NCT03654885|144200395|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Percentage Difference|-27.6||||0.014|TWO_SIDED|95.0|-47.6|-5.9|||Fisher Exact|||Percentage of Participants Achieving Specific Percentage IOP Lower Targets From Baseline at Month 12 With Medication-free Eyes: ≥45% IOP Reduction||-5.9|-47.6|0.014
72338315|NCT03654885|144200395|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Percentage Difference|-30.9||||0.006|TWO_SIDED|95.0|-50.8|-9.5|||Fisher Exact|||Percentage of Participants Achieving Specific Percentage IOP Lower Targets From Baseline at Month 12 With Medication-free Eyes: ≥50% IOP Reduction||-9.5|-50.8|0.006
72338316|NCT03654885|144200402|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Least Square Mean Difference|1.0|STANDARD_ERROR_OF_MEAN|0.35||0.004|TWO_SIDED|95.0|0.33|1.72|||Mixed Model for Repeated Measures|MMRM model with treatment and time as the factors, treatment by time interaction and baseline as the covariate variables were used for analysis||Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) With Current Glasses: Day 1||1.72|0.33|0.004
72338317|NCT03654885|144200402|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Least Square Mean Difference|1.2|STANDARD_ERROR_OF_MEAN|0.36||0.001|TWO_SIDED|95.0|0.47|1.88||MMRM model with treatment and time as the factors, treatment by time interaction and baseline as the covariate variables were used for analysis|Mixed Model for Repeated Measures|||Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) With Current Glasses:Week 1||1.88|0.47|0.001
72428144|NCT02564055|144367366|OTHER||Difference in percentages|-24.2|||||TWO_SIDED|95.0|-60.8|14.8|||||Difference between GSK2894512 1 % BID and vehicle BID at Week 2 has been presented.|||14.8|-60.8|
72428145|NCT02564055|144367366|OTHER||Difference in percentages|28.5|||||TWO_SIDED|95.0|-13.7|63.0|||||Difference between GSK2894512 1 % QD and vehicle QD at Week 2 has been presented.|||63.0|-13.7|
72338318|NCT03654885|144200402|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Least Square Mean Difference|0.5|STANDARD_ERROR_OF_MEAN|0.36||0.162|TWO_SIDED|95.0|-0.2|1.2||MMRM model with treatment and time as the factors, treatment by time interaction and baseline as the covariate variables were used for analysis|Mixed Model for Repeated Measures|||Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) With Current Glasses:Week 2||1.20|-0.20|0.162
72338319|NCT03654885|144200402|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Least Square Mean Difference|0.5|STANDARD_ERROR_OF_MEAN|0.36||0.185|TWO_SIDED|95.0|-0.23|1.19||MMRM model with treatment and time as the factors, treatment by time interaction and baseline as the covariate variables were used for analysis|Mixed Model for Repeated Measures|||Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) With Current Glasses:Month 1||1.19|-0.23|0.185
72338320|NCT03654885|144200402|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Least Square Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.36||0.846|TWO_SIDED|95.0|-0.64|0.79||MMRM model with treatment and time as the factors, treatment by time interaction and baseline as the covariate variables were used for analysis|Mixed Model for Repeated Measures|||Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) With Current Glasses:Month 3||0.79|-0.64|0.846
72338321|NCT03654885|144200402|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Least Square Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.36||0.965|TWO_SIDED|95.0|-0.73|0.7||MMRM model with treatment and time as the factors, treatment by time interaction and baseline as the covariate variables were used for analysis|Mixed Model for Repeated Measures|||Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) With Current Glasses:Month 6||0.70|-0.73|0.965
72338322|NCT03654885|144200402|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Least Square Mean Difference|0.6|STANDARD_ERROR_OF_MEAN|0.37||0.096|TWO_SIDED|95.0|-0.11|1.33||MMRM model with treatment and time as the factors, treatment by time interaction and baseline as the covariate variables were used for analysis|Mixed Model for Repeated Measures|||Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) With Current Glasses:Month 9||1.33|-0.11|0.096
72338323|NCT03654885|144200402|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Least Square Mean Difference|0.7|STANDARD_ERROR_OF_MEAN|0.37||0.063|TWO_SIDED|95.0|-0.04|1.43||MMRM model with treatment and time as the factors, treatment by time interaction and baseline as the covariate variables were used for analysis|Mixed Model for Repeated Measures|||Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) With Current Glasses:Month 12||1.43|-0.04|0.063
72338324|NCT03654885|144200403|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Least Square Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.027||0.048|TWO_SIDED|95.0|-0.105|0.0|||Mixed Model for Repeated Measures|||Mean Change From Baseline in Manifest Refraction - Mean Visual Acuity Using Snellen in LogMAR Scale: Month 1||0.000|-0.105|0.048
72338325|NCT03654885|144200403|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Least Square Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.027||0.742|TWO_SIDED|95.0|-0.062|0.045|||Mixed Model for Repeated Measures|||Mean Change From Baseline in Manifest Refraction - Mean Visual Acuity Using Snellen in LogMAR Scale: Month 3||0.045|-0.062|0.742
72428146|NCT02564055|144367366|OTHER||Difference in percentages|-33.3|||||TWO_SIDED|95.0|-67.4|6.1|||||Difference between GSK2894512 0.5 % BID and vehicle BID at Week 2 has been presented.|||6.1|-67.4|
72338326|NCT03654885|144200403|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Least Square Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.027||0.925|TWO_SIDED|95.0|-0.056|0.051|||Mixed Model for Repeated Measures|||Mean Change From Baseline in Manifest Refraction - Mean Visual Acuity Using Snellen in LogMAR Scale: Month 6||0.051|-0.056|0.925
72338327|NCT03654885|144200403|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Least Square Mean Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.028||0.021|TWO_SIDED|95.0|-0.118|-0.01|||Mixed Model for Repeated Measures|||Mean Change From Baseline in Manifest Refraction - Mean Visual Acuity Using Snellen in LogMAR Scale: Month 12||-0.010|-0.118|0.021
72338328|NCT03654885|144200406|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Least Square Mean Difference|-0.562|STANDARD_ERROR_OF_MEAN|0.3231||0.087|TWO_SIDED|95.0|-1.2082|0.0851|||Mixed Model for Repeated Measures|||Mean Change from Baseline in Surgically Induced Astigmatism - Topography at Selected Sites at Week 1||0.0851|-1.2082|0.087
72338329|NCT03654885|144200406|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Least Square Mean Difference|-0.138|STANDARD_ERROR_OF_MEAN|0.3355||0.682|TWO_SIDED|95.0|-0.809|0.5324|||Mixed Model for Repeated Measures|||Mean Change from Baseline in Surgically Induced Astigmatism - Topography at Selected Sites at Month 1||0.5324|-0.8090|0.682
72338330|NCT03654885|144200406|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Least Square Mean Difference|-0.452|STANDARD_ERROR_OF_MEAN|0.3484||0.199|TWO_SIDED|95.0|-1.1483|0.2434|||Mixed Model for Repeated Measures|||Mean Change from Baseline in Surgically Induced Astigmatism - Topography at Selected Sites at Month 12||0.2434|-1.1483|0.199
72338331|NCT03654885|144200407|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Least Square Mean Difference|-0.001|STANDARD_ERROR_OF_MEAN|0.2026||0.997|TWO_SIDED|95.0|-0.4103|0.4086|||Mixed Model for Repeated Measures|||Mean Change in Optical Biometry - Anterior Chamber Depth at Day 1||0.4086|-0.4103|0.997
72338332|NCT03654885|144200407|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Least Square Mean Difference|0.222|STANDARD_ERROR_OF_MEAN|0.2124||0.302|TWO_SIDED|95.0|-0.2068|0.6506|||Mixed Model for Repeated Measures|||Mean Change in Optical Biometry - Anterior Chamber Depth at Week 2||0.6506|-0.2068|0.302
72338333|NCT03654885|144200408|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Least Square Mean Difference|0.343|STANDARD_ERROR_OF_MEAN|0.3336||0.309|TWO_SIDED|95.0|-0.3289|1.0154|||Mixed Model for Repeated Measures|||Mean Change in from Baseline Optical Biometry - K1 at Day 1||1.0154|-0.3289|0.309
72428147|NCT02564055|144367366|OTHER||Difference in percentages|-0.9|||||TWO_SIDED|95.0|-40.7|40.7|||||Difference between GSK2894512 0.5 % QD and vehicle QD at Week 2 has been presented.|||40.7|-40.7|
72428148|NCT02564055|144367366|OTHER||Difference in percentages|-15.2|||||TWO_SIDED|95.0|-53.8|23.5|||||Difference between GSK2894512 1 % BID and vehicle BID at Week 4 has been presented.|||23.5|-53.8|
72338334|NCT03654885|144200408|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Least Square Mean Difference|0.261|STANDARD_ERROR_OF_MEAN|0.3278||0.43|TWO_SIDED|95.0|-0.3993|0.922|||Mixed Model for Repeated Measures|||Mean Change in from Baseline Optical Biometry - K1 at Week 2||0.9220|-0.3993|0.430
72338335|NCT03654885|144200408|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Least Square Mean Difference|-0.409|STANDARD_ERROR_OF_MEAN|0.4457||0.363|TWO_SIDED|95.0|-1.3071|0.4882|||Mixed Model for Repeated Measures|||Mean Change in from Baseline Optical Biometry - K2 at Day 1||0.4882|-1.3071|0.363
72338336|NCT03654885|144200408|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Least Square Mean Difference|-0.488|STANDARD_ERROR_OF_MEAN|0.4383||0.272|TWO_SIDED|95.0|-1.3709|0.3954|||Mixed Model for Repeated Measures|||Mean Change in from Baseline Optical Biometry - K2 at Week 2||0.3954|-1.3709|0.272
72338337|NCT03654885|144200408|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Least Square Mean Difference|-0.765|STANDARD_ERROR_OF_MEAN|0.4502||0.096|TWO_SIDED|95.0|-1.6722|0.142|||Mixed Model for Repeated Measures|||Mean Change in from Baseline Optical Biometry - Delta D at Day 1||0.1420|-1.6722|0.096
72338338|NCT03654885|144200408|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Least Square Mean Difference|-0.576|STANDARD_ERROR_OF_MEAN|0.4411||0.198|TWO_SIDED|95.0|-1.4655|0.3129|||Mixed Model for Repeated Measures|||Mean Change in from Baseline Optical Biometry - Delta D at Week 2||0.3129|-1.4655|0.198
72338339|NCT03654885|144200419|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Least Square Mean Difference|-3.031|STANDARD_ERROR_OF_MEAN|4.3331||0.485|TWO_SIDED|95.0|-11.5597|5.4973|||Mixed Model for Repeated Measures|||PRO: Change From Baseline in Symptom and Health Problem Checklist (SHPC-18)- Local Eye Symptoms Score||5.4973|-11.5597|0.485
72338340|NCT03654885|144200419|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Least Square Mean Difference|-10.507|STANDARD_ERROR_OF_MEAN|4.5666||0.022|TWO_SIDED|95.0|-19.5|-1.5144|||Mixed Model for Repeated Measures|||PRO: Change From Baseline in Symptom and Health Problem Checklist (SHPC-18)- Vision Function Problem Score||-1.5144|-19.5000|0.022
72338341|NCT03654885|144200419|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Least Square Mean Difference|-7.528|STANDARD_ERROR_OF_MEAN|4.0382||0.064|TWO_SIDED|95.0|-15.4841|0.4275|||Mixed Model for Repeated Measures|||PRO: Change From Baseline in Symptom and Health Problem Checklist (SHPC-18)- Total Bothersome Score||0.4275|-15.4841|0.064
72428149|NCT02564055|144367366|OTHER||Difference in percentages|43.4|||||TWO_SIDED|95.0|2.7|74.6|||||Difference between GSK2894512 1 % QD and vehicle QD at Week 4 has been presented.|||74.6|2.7|
72338342|NCT03654885|144200419|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Least Square Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.42||0.278|TWO_SIDED|95.0|-1.28|0.37|||Mixed Model for Repeated Measures|||PRO: Change From Baseline in Symptom and Health Problem Checklist (SHPC-18)- Local Eye Symptoms Frequency Score||0.37|-1.28|0.278
72338343|NCT03654885|144200419|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Least Square Mean Difference|-1.7|STANDARD_ERROR_OF_MEAN|0.63||0.007|TWO_SIDED|95.0|-2.96|-0.47|||Mixed Model for Repeated Measures|||PRO: Change From Baseline in Symptom and Health Problem Checklist (SHPC-18)- Vision Function Problem Frequency Score||-0.47|-2.96|0.007
72338344|NCT03654885|144200420|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.||||||0.534|||||||Fisher Exact|||PRO: Percentage of Participants With Post-Surgical Resumption of Activities and Daily Routine- Not at all||||0.534
72338345|NCT03654885|144200420|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.||||||0.263|||||||Fisher Exact|||PRO: Percentage of Participants With Post-Surgical Resumption of Activities and Daily Routine- Somewhat||||0.263
72428150|NCT02564055|144367366|OTHER||Difference in percentages|-15.2|||||TWO_SIDED|95.0|-53.8|23.5|||||Difference between GSK2894512 0.5 % BID and vehicle BID at Week 4 has been presented.|||23.5|-53.8|
72428151|NCT02564055|144367366|OTHER||Difference in percentages|9.1|||||TWO_SIDED|95.0|-35.6|51.2|||||Difference between GSK2894512 0.5 % QD and vehicle QD at Week 4 has been presented.|||51.2|-35.6|
72428152|NCT02564055|144367366|OTHER||Difference in percentages|18.3|||||TWO_SIDED|95.0|-25.1|57.1|||||Difference between GSK2894512 1 % BID and vehicle BID at Week 8 has been presented.|||57.1|-25.1|
72338346|NCT03654885|144200420|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.||||||1|||||||Fisher Exact|||PRO: Percentage of Participants With Post-Surgical Resumption of Activities and Daily Routine- Moderately so||||1.000
72338347|NCT03654885|144200420|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.||||||0.018|||||||Fisher Exact|||PRO: Percentage of Participants With Post-Surgical Resumption of Activities and Daily Routine- Mostly||||0.018
72338348|NCT03654885|144200420|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.||||||0.35|||||||Fisher Exact|||PRO: Percentage of Participants With Post-Surgical Resumption of Activities and Daily Routine- Completely||||0.350
72338349|NCT03654885|144200420|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.||||||0.264|||||||Fisher Exact|||PRO: Percentage of Participants With Post-Surgical Resumption of Activities and Daily Routine- Missing||||0.264
72338350|NCT03654885|144200421|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Least Square Mean Difference|-8.303|STANDARD_ERROR_OF_MEAN|16.1445||0.61|TWO_SIDED|95.0|-40.8681|24.2624|||Mixed Model for Repeated Measures|||PRO: Percent Change From Baseline in Work Productivity and Activity Impairment- Percent Overall Work Impairment Due to Health||24.2624|-40.8681|0.610
72338351|NCT03654885|144200422|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Least Square Mean Difference|-13.9|STANDARD_ERROR_OF_MEAN|8.33||0.097|TWO_SIDED|95.0|-30.32|2.52|||Mixed Model for Repeated Measures|||PRO: Percent Change From Baseline in Work Productivity and Activity Impairment-Percent Activity Impairment Due to Health||2.52|-30.32|0.097
72428153|NCT02564055|144367366|OTHER||Difference in percentages|47.7|||||TWO_SIDED|95.0|4.8|78.7|||||Difference between GSK2894512 1 % QD and vehicle QD at Week 8 has been presented.|||78.7|4.8|
72428154|NCT02564055|144367366|OTHER||Difference in percentages|-11.7|||||TWO_SIDED|95.0|-51.3|30.2|||||Difference between GSK2894512 0.5 % BID and vehicle BID at Week 8 has been presented.|||30.2|-51.3|
72338352|NCT02210832|144200434|SUPERIORITY|38.27% vs. 9.09%|||||<|0.001||||||p value is not adjusted for multiple comparisons. A priori threshold for significance was P \< 0.05.|Chi-squared|chi square test statistic = 20.23, df = 1||Hypothesized that women assigned to Best practices plus financial incentives would achieve greater abstinence than women assigned to Best practices only.||||<0.001
72338353|NCT02210832|144200435|SUPERIORITY||||||<|0.05|TWO_SIDED|95.0|||||Chi-squared|Used generalized estimating equation utilizing a logistic link function with treatment condition and assessment time adjusting for covariates.||||||<0.05
72338354|NCT02210832|144200435|SUPERIORITY|||||||0.003||||||chi square test statistic = 21.93, df=7|Mixed Models Analysis|Conducted a generalized estimating equation utilizing a logistic link function with treatment condition and assessment time adjusting for covariates.||Trial condition by assessment time interaction||||0.003
72338355|NCT02210832|144200436|SUPERIORITY|||||||0.48||||||chi square test statistic = 9.52, df = 10|Mixed Models Analysis|Conducted a generalized estimating equation utilizing a logistic link function with treatment condition and assessment time adjusting for covariates.||Interaction of trial condition and time||||0.48
72338356|NCT02210832|144200437|SUPERIORITY||||||<|0.0001||||||chi square test statistic = 33.51, df = 2|Mixed Models Analysis|Conducted a generalized estimating equation utilizing a logistic link function with treatment condition and assessment time adjusting for covariates.||Examining main effect of treatment condition.||||<0.0001
72338357|NCT02210832|144200437|SUPERIORITY|||||||0.89||||||chi square test statistic = 5.00, df = 10.|Mixed Models Analysis|||Testing interaction of treatment condition and assessment time||||0.89
72338358|NCT02210832|144200438|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|Method was mixed model repeated measures analysis of covariance.||||||<0.001
72338359|NCT02210832|144200439|SUPERIORITY||||||<|0.001||||||F\[7,922\]=3.62|ANCOVA|Repeated measures analysis of covariance was conducted with Bonferroni corrections for post-doc tests and across repeated assessments.||Examine interaction of treatment condition and assessment time.||||<0.001
72338360|NCT02210832|144200439|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|Method was mixed model repeated measures analysis of covariance.||||||<0.001
72338361|NCT02210832|144200440|SUPERIORITY|||||||0.009|||||||Mixed Models Analysis|Method was mixed model repeated measures analysis of covariance.||||||0.009
72338362|NCT02210832|144200441|SUPERIORITY|||||||0.01|||||||Regression, Logistic|Method is logistic regression adjusted for covariates.||||||0.01
72338363|NCT02210832|144200442|SUPERIORITY||||||<|0.05|||||||Chi-squared|||||||<0.05
72338364|NCT02210832|144200443|SUPERIORITY||||||<|0.05|||||||Chi-squared|||||||<0.05
72338365|NCT02210832|144200445|SUPERIORITY||||||<|0.05|||||||ANCOVA|||||||<0.05
72338366|NCT02210832|144200449|SUPERIORITY|||||||0.006|||||||ANCOVA|All comparisons adjusted for infant gestational age at time of delivery.||||||0.006
72338367|NCT02080260|144200451|SUPERIORITY||16-week PFS Rate|0.1||||0.824|TWO_SIDED|95.0|0.012|0.317||This p-value is only based on partial enrollment of the study. The study enrollment was stopped early due to futility.|Fisher Exact||Confidence interval estimated using the Clopper Pearson method.|The null hypothesis assumes a median PFS of 6 weeks, corresponding to a 16-week PFS rate of approximately 0.15. A single-stage design will be used to test that the 16-week PFS rate is less than or equal to 0.15. If at least 8 of the 32 subjects are alive and progression free at 16 weeks, the null hypothesis will be rejected. Assuming a one-sided alpha = 0.10 significance level, this will provide at least 90% power to reject the null hypothesis, assuming the true 16-week PFS rate is 0.35.||0.317|0.012|0.824
72338368|NCT02080260|144200452|OTHER|Estimation only.|Median|6.1|||||TWO_SIDED|95.0|2.9|7.1|||||The Kaplan Meier method was used to estimate the median PFS(in weeks) for the population. The Greenwood method was used to estimate the confidence limits of the median progression free survival.|||7.1|2.9|
72338369|NCT02080260|144200453|OTHER|Estimation only.|Median|9.4|||||TWO_SIDED|95.0|8.1|17.0|||||The Kaplan Meier method was used to estimate the median OS(in weeks) for the population. The Greenwood method was used to estimate the confidence limits of the median progression free survival.|||17.0|8.1|
72338370|NCT02080260|144200454|OTHER|Estimation only|Overall Response Rate|0.05|||||TWO_SIDED|95.0|0.001|0.249|||||Confidence interval estimated using the Clopper Pearson method.|||0.249|0.001|
72338371|NCT02080260|144200455|OTHER|Estimation only.|Disease Control Rate|0.3|||||TWO_SIDED|95.0|0.119|0.543|||||Confidence interval estimated using the Clopper Pearson method.|||0.543|0.119|
72338372|NCT00628589|144200480|SUPERIORITY|LS mean was used in the primary efficacy analysis||||||0.0004|||||||ANCOVA|p-values (adjusted) using Dunnett's t-test in main effects ANCOVA model||||||0.0004
72338373|NCT00628589|144200480|SUPERIORITY||||||<|0.0001|||||||ANCOVA|p-values (adjusted) using Dunnett's t-test in main effects ANCOVA model||||||<0.0001
72338374|NCT00628589|144200481|SUPERIORITY|||||||0.0015|||||||Fisher Exact|||||||0.0015
72338375|NCT00628589|144200481|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||||||<0.0001
72338376|NCT00628589|144200482|SUPERIORITY|||||||0.0015|||||||Fisher Exact|||||||0.0015
72338377|NCT00628589|144200482|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||||||<0.0001
72338378|NCT01030874|144200485|OTHER||Odds Ratio (OR)|1.16||||0.6|TWO_SIDED|95.0|0.67|1.99|||Regression, Logistic|Adjusted for whether patient had orthostatic hypotension at baseline.|Arm 2 is in the numerator of OR calculation.|||1.99|0.67|0.6
72338379|NCT01030874|144200486|OTHER||Odds Ratio (OR)|1.53||||0.3|TWO_SIDED|95.0|0.74|3.24|||Regression, Logistic|Adjusted for whether patient had orthostatic hypotension at discharge.|Arm 2 is in the numerator of OR calculation.|||3.24|0.74|0.3
72428155|NCT02564055|144367366|OTHER||Difference in percentages|9.1|||||TWO_SIDED|95.0|-35.6|51.2|||||Difference between GSK2894512 0.5 % QD and vehicle QD at Week 8 has been presented.|||51.2|-35.6|
72338380|NCT02498067|144200487|OTHER|||||||0.177||||||a priori threshold for statistical significance: p\<0.05|t-test, 2 sided|||Paired samples t-test comparison of whether participants' mean reported scores for frequency of dual method use differ between baseline (pre-rPlan) and 3-month follow-up (post-rPlan)||||.177
72338381|NCT02498067|144200488|OTHER|||||||0.318||||||a priori threshold for statistical significance: p\<.05|t-test, 2 sided|||Paired samples t-test comparison of whether participants' mean reported scores for frequency of condom use alone (without another method) differ between baseline (pre-rPlan) and 3-month follow-up (post-rPlan)||||.318
72338382|NCT02498067|144200489|OTHER|||||||0||||||a priori threshold for statistical significance: p\<.05|t-test, 2 sided|||Paired samples t-test comparison of whether participants reported more consistent contraceptive use (i.e., using contraception every time they had sex) between baseline (pre-rPlan) and 3-month follow-up (post-rPlan)||||.000
72338383|NCT02498067|144200491|OTHER|||||||0.03||||||a priori threshold for statistical significance: p\<.05|t-test, 2 sided|||Paired samples t-test comparison of participants' reported likelihood to use an IUD in the future (on a scale ranging from 1- very unlikely, to 5- very likely) before and directly after using the rPlan app||||.030
72338384|NCT02498067|144200492|OTHER|||||||0.14||||||a priori threshold for statistical significance: p\<.05|t-test, 2 sided|||Paired samples t-test comparison of participants' reported likelihood to use an implant in the future (on a scale ranging from 1- very unlikely, to 5- very likely) before and directly after using the rPlan app||||.140
72338385|NCT02498067|144200493|OTHER|||||||0.315||||||a priori threshold for statistical significance: p\<.05|t-test, 2 sided|||Paired samples t-test comparison of participants' reported likelihood to use condoms in the future (on a scale ranging from 1- very unlikely, to 5- very likely) before and directly after using the rPlan app||||.315
72338386|NCT02498067|144200494|OTHER|||||||0.028||||||a priori threshold for statistical significance: p\<.05|t-test, 2 sided|||Paired samples t-test comparison of participants' reported contraceptive self-efficacy (on a scale ranging from 1- not at all confident, to 5- extremely confident) before and 3 months after engaging in rPlan||||.028
72338387|NCT02498067|144200495|OTHER|||||||0.918||||||a priori threshold for statistical significance: p\<.05|t-test, 2 sided|||Paired samples t-test comparison of participants' reported condom use self-efficacy (on a scale ranging from 1- not at all confident, to 5- extremely confident) before and 3 months after engaging in rPlan||||.918
72338388|NCT02498067|144200497|OTHER|||||||0.209||||||a priori threshold for statistical significance: p\<.05|t-test, 2 sided|||Paired samples t-test comparison of participants' self-reported number of sexual partners in the past 3 months (for those were sexually active) between baseline and 3-month follow-up||||.209
72338389|NCT02498067|144200498|OTHER|||||||0.652||||||a priori threshold for statistical significance: p\<.05|t-test, 2 sided|||Paired samples t-test comparison of participants' reported degree to which they endorse negative condom attitudes (on a scale ranging from 1- strongly disagree, to 5- strongly agree) before and 3 months after engaging in rPlan||||.652
72338390|NCT02498067|144200499|OTHER|||||||0.498||||||a priori threshold for statistical significance: p\<.05|t-test, 2 sided|||Paired samples t-test comparison of participants' reported degree to which they endorse positive motivators for condom use (on a scale ranging from 1- strongly disagree, to 5- strongly agree) before and 3 months after engaging in rPlan||||.498
72338391|NCT02498067|144200500|OTHER|||||||0.977||||||a priori threshold for statistical significance: p\<.05|t-test, 2 sided|||Paired samples t-test comparison of participants' rated importance of negative contraceptive attitudes on their decision to use contraception (on a scale ranging from 1- not at all important, to 5- extremely important) before and 3 months after engaging in rPlan||||.977
72338392|NCT02498067|144200501|OTHER|||||||0.673||||||a priori threshold for statistical significance: p\<.05|t-test, 2 sided|||Paired samples t-test comparison of participants' rated importance of positive motivators for contraceptive use on their decision to use contraception (on a scale ranging from 1- not at all important, to 5- extremely important) before and 3 months after engaging in rPlan||||.673
72338393|NCT02498067|144200502|OTHER|||||||0.049||||||a priori threshold for statistical significance: p\<.05|t-test, 2 sided|||Paired samples t-test comparison of proportion of participants who provided correct answers to whether pills or condoms are more effective at preventing pregnancy, before and 3 months after engaging in rPlan||||.049
72338394|NCT02498067|144200502|OTHER|||||||0.265||||||a priori threshold for statistical significance: p\<.05|t-test, 2 sided|||Paired samples t-test comparison of proportion of participants who provided correct answers to whether the IUD or shot is more effective at preventing pregnancy, before and 3 months after engaging in rPlan||||.265
72338395|NCT02337530|144200503|SUPERIORITY||Odds Ratio (OR)|1.37||||0.73|TWO_SIDED|95.0|0.28|7.01|||Fisher Exact|||||7.01|0.28|0.73
72338396|NCT02337530|144200503|SUPERIORITY||Odds Ratio (OR)|6.4||||0.01|TWO_SIDED|95.0|1.65|24.8|||Fisher Exact|||||24.8|1.65|0.01
72338397|NCT02337530|144200504|SUPERIORITY||Hazard Ratio (HR)|0.82||||0.56|TWO_SIDED|95.0|0.42|1.6|||Log Rank|||||1.60|0.42|0.56
72338398|NCT02337530|144200504|SUPERIORITY||Hazard Ratio (HR)|0.77||||0.44|TWO_SIDED|95.0|0.4|1.49|||Log Rank|||||1.49|0.40|0.44
72338399|NCT03249935|144200533|SUPERIORITY|||||||||||||||||Assumptions were that 20% of enrolled chlamydia-infected males will have urethral symptoms and azithromycin treatment failures will occur in 10% of symptomatic men vs. 2% of asymptomatic men. At a one-sided 0.05 significance level with power of 0.80, a sample size of 357 evaluable males would be needed, or approximately 72 symptomatic and 285 asymptomatic males. Assuming 20% of males enrolled would be unevaluable, a total of 446 males was targeted for enrollment.|Given that the study closed early and there were only 4 treatment failures, formal hypothesis testing was not performed.|||
72338400|NCT03249935|144200534|SUPERIORITY||Odds Ratio (OR)|0.75||||0.656|TWO_SIDED|95.0|0.22|2.62|||Regression, Logistic|||Unadjusted odds ratio for age in years as a continuous variable in a logistic regression model predicting treatment failure at day 28||2.62|0.22|0.656
72338401|NCT03249935|144200534|SUPERIORITY||Odds Ratio (OR)|4.65||||0.197|TWO_SIDED|95.0|0.45|47.89|||Regression, Logistic|||Unadjusted odds ratio for reporting at baseline new partners in the last 30 days (reference group=no new partners) from a logistic model predicting treatment failure at day 28.||47.89|0.45|0.197
72338402|NCT03249935|144200534|SUPERIORITY||Odds Ratio (OR)|0.68||||0.058|TWO_SIDED|95.0|0.45|1.01|||Regression, Logistic|||Unadjusted odds ratio for Chlamydia viral load at baseline as a continuous variable in a logistic model predicting treatment failure at day 28.||1.01|0.45|0.058
72338403|NCT01229943|144200535|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.8||||0.12|TWO_SIDED|95.0|0.55|1.17||Tests were stratified by: prior treatment with cytotoxic chemotherapy (no vs yes), prior use of octreotide (no vs yes), and prior therapy with sunitinib (no vs yes).|Log Rank|||Based on the log rank test, with 130 patients enrolled over 22 months and followed an additional 24 months, the difference in median PFS between 9 months and 14 months can be detected with approximately 90% power (1-sided, α=0.15).||1.17|0.55|0.12
72338404|NCT01669421|144200567|OTHER|Data was analyzed with multiple repeat ANOVA for all visits and paired samples were also evaluated.|||||<|0.05|||||||Kruskal-Wallis|||IL-2||||<0.05
72428156|NCT02564055|144367366|OTHER||Difference in percentages|6.4|||||TWO_SIDED|95.0|-35.4|48.5|||||Difference between GSK2894512 1 % BID and Vehicle BID at Week 12 has been presented.|||48.5|-35.4|
72428157|NCT02564055|144367366|OTHER||Difference in percentages|6.0|||||TWO_SIDED|95.0|-35.8|47.1|||||Difference between GSK2894512 1 % QD and Vehicle QD at Week 12 has been presented.|||47.1|-35.8|
72338405|NCT01669421|144200567|OTHER|Kruskal-Wallis||||||0.035|||||||Kruskal-Wallis|||IL-4||||0.035
72338406|NCT01669421|144200567|OTHER|||||||0.33|||||||Kruskal-Wallis|||IL-8||||0.33
72338407|NCT01669421|144200567|OTHER|||||||0.68|||||||Kruskal-Wallis|||IL-9||||0.68
72338408|NCT01669421|144200567|OTHER|||||||0.02|||||||Kruskal-Wallis|||IL-17||||0.020
72338409|NCT01669421|144200567|OTHER|||||||0.021|||||||Kruskal-Wallis|||FGF||||0.021
72338410|NCT01669421|144200567|OTHER|||||||0.02|||||||Kruskal-Wallis|||Eotaxin||||0.02
72338411|NCT01669421|144200567|OTHER|||||||0.045|||||||Kruskal-Wallis|||GM-CSF||||0.045
72428158|NCT02564055|144367366|OTHER||Difference in percentages|-13.6|||||TWO_SIDED|95.0|-54.0|31.2|||||Difference between GSK2894512 0.5 % BID and Vehicle BID at Week 12 has been presented.|||31.2|-54.0|
72338412|NCT01669421|144200567|OTHER|||||||0.47|||||||Kruskal-Wallis|||IL15||||0.47
72338413|NCT01669421|144200567|OTHER|||||||0.9|||||||Kruskal-Wallis|||IL-1a||||0.90
72338414|NCT01669421|144200567|OTHER|||||||0.8|||||||Kruskal-Wallis|||IL18||||0.80
72338415|NCT01669421|144200567|OTHER|||||||0.027|||||||Kruskal-Wallis|||M-CSF||||0.027
72338416|NCT01669421|144200568|OTHER|||||||0.07|||||||Kruskal-Wallis|||No power calculation and this is an exploratory pilot analysis We expected cytokines to decrease after subjects receive double dose and a rebound after administering standard dose.||||0.07
72338417|NCT01669421|144200570|OTHER|between Week 4 and Week 8||||||0.03|||||||t-test, 2 sided|||Desmosine (DES) and isodesmosine (IDES) are used as indicator of elastin degradation. Levels of DES/IDES were measured using high-performance liquid chromatography and tandem mass spectrometry.||||0.03
72338418|NCT01669421|144200570|OTHER|||||||0.33|||||||t-test, 2 sided|||between Week 8 and Week 12||||0.33
72338419|NCT01669421|144200570|OTHER|||||||0.029|||||||Kruskal-Wallis|||between Week 4 and Week 12||||0.029
72338420|NCT02961790|144200604|SUPERIORITY|||||||0.0041|||||||Kruskal-Wallis|||||||0.0041
72338421|NCT02961790|144200604|SUPERIORITY|||||||0.0001|||||||Kruskal-Wallis|||||||0.0001
72338422|NCT02961790|144200605|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|Adjusted for effects specified in outcome measure description.||||||<0.0001
72428159|NCT02564055|144367366|OTHER||Difference in percentages|-25.6|||||TWO_SIDED|95.0|-65.3|22.4|||||Difference between GSK2894512 0.5 % QD and Vehicle QD at Week 12 has been presented.|||22.4|-65.3|
72428160|NCT02564055|144367366|OTHER||Difference in percentages|-1.0|||||TWO_SIDED|95.0|-44.5|42.7|||||Difference between GSK2894512 1 % BID and Vehicle BID at Week 14 has been presented.|||42.7|-44.5|
72338423|NCT02961790|144200606|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|Adjusted for effects specified in outcome measure description.||||||<0.0001
72338424|NCT02961790|144200607|SUPERIORITY|||||||0.0174|||||||Kruskal-Wallis|||||||0.0174
72338425|NCT02961790|144200607|SUPERIORITY|||||||0.0279|||||||Kruskal-Wallis|||||||0.0279
72338426|NCT02961790|144200608|SUPERIORITY|||||||0.0011|||||||Kruskal-Wallis|||||||0.0011
72338427|NCT02961790|144200608|SUPERIORITY|||||||0.0025|||||||Kruskal-Wallis|||||||0.0025
72338428|NCT02370641|144200641|OTHER||Mean Difference (Final Values)|-4.0||||0.012|TWO_SIDED|||||p\<0.05 is defined as significant|Wilcoxon (Mann-Whitney)|||Comparison was made to week 4 minus baseline change of phylum Firmicutes abundance between urolithin excretors and non excretors||||0.012
72338429|NCT02370641|144200641|OTHER||Mean Difference (Final Values)|2.6||||0.009|TWO_SIDED|||||p\<0.05 was defined as significant|Wilcoxon (Mann-Whitney)|||Comparison was made to week 4 minus baseline change of phylum Proteobacteria abundance between urolithin excretors and non excretors||||0.009
72338430|NCT01479595|144200642|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.514||||0.005|TWO_SIDED|90.0|-0.811|-0.217|||Mixed Models Analysis|||||-0.217|-0.811|0.005
72338431|NCT05268744|144200653|SUPERIORITY|Since all outcomes were normally distributed, one-sided paired t-test was used to compare mean pre- and post-treatment scores to see whether post-treatment scores of ABI-S and SRS had improved compared to pre-treatment scores|||||<|0.05|||||||t-test, 1 sided|||Null hypothesis was no improvement in mean ABI-S and SRS scores at the end of the study, compared to baseline||||<0.05
72338432|NCT02133664|144200669|SUPERIORITY||Mean Difference (Final Values)|1.14|STANDARD_ERROR_OF_MEAN|1.57||0.05|TWO_SIDED|95.0|-2.03|4.32|||t-test, 2 sided|||With the initial sample size plan of 53 subjects, we expect an 80% power to detect a significant difference in PASAT score with a mean difference of 8.3 points between the treatment and placebo group.||4.32|-2.03|0.05
72338433|NCT03906656|144200673|SUPERIORITY||Mean Difference (Final Values)|3.5|STANDARD_DEVIATION|8.1||0.0002|TWO_SIDED|||||Adjusted p-values based on Holm-Bonferroni method. P-values \< 0.05 used as threshold for statistical significance.|t-test, 2 sided||Mean difference is for paired data (n=73). This explains the discrepancy between the mean difference and the difference between the KAFO and C-Brace means (n=86 and n=77, respectively).|H0: the mean difference (C-Brace - KAFO) \<= 0.||||0.0002
72338434|NCT03906656|144200673|SUPERIORITY||Mean Difference (Final Values)|6.8|STANDARD_DEVIATION|9.7|<|1e-05|TWO_SIDED|||||Adjusted p-values based on Holm-Bonferroni method. P-values \< 0.05 used as threshold for statistical significance.|t-test, 2 sided||Mean difference is for paired data (n=77). This explains the discrepancy between the mean difference and the difference between the KAFO and C-Brace means (n=86 and n=77, respectively).|H0: the mean difference (C-Brace - Baseline) \<= 0.||||<0.00001
72338435|NCT03906656|144200673|SUPERIORITY||Mean Difference (Final Values)|3.3|STANDARD_DEVIATION|6.3|<|1e-05|TWO_SIDED||||||t-test, 2 sided||Mean difference is for paired data (n=86). This explains the discrepancy between the mean difference and the difference between the Baseline and KAFO means (n=102 and n=86, respectively).|KAFO vs. Baseline -- H0: the mean difference (KAFO - Baseline) \<= 0.||||<0.00001
72338436|NCT03906656|144200674|SUPERIORITY||Mean Difference (Final Values)|7.05|STANDARD_DEVIATION|26.3||0.005|TWO_SIDED|||||P-value not adjusted for multiple comparisons. P-values \< 0.05 used as threshold for statistical significance.|t-test, 2 sided|63.6 degrees of freedom.||H0: the mean difference (C-Brace - KAFO) \<= 0||||0.005
72338437|NCT03906656|144200675|SUPERIORITY|P-values not adjusted for multiple comparisons. P-values \< 0.05 used as threshold for statistical significance.|Mean Difference (Final Values)|1.0|STANDARD_DEVIATION|3.7||0.005|TWO_SIDED|||||P-values not adjusted for multiple comparisons. P-values \< 0.05 used as threshold for statistical significance.|t-test, 2 sided|74.4 degrees of freedom||H0: the mean difference (C-Brace - KAFO) \<= 0.||||0.005
72428161|NCT02564055|144367366|OTHER||Difference in percentages|5.6|||||TWO_SIDED|95.0|-37.8|47.3|||||Difference between GSK2894512 1 % QD and Vehicle QD at Week 14 has been presented.|||47.3|-37.8|
72428162|NCT02564055|144367366|OTHER||Difference in percentages|-5.5|||||TWO_SIDED|95.0|-47.9|37.6|||||Difference between GSK2894512 0.5 % BID and Vehicle BID at Week 14 has been presented.|||37.6|-47.9|
72428163|NCT02564055|144367366|OTHER||Difference in percentages|-4.4|||||TWO_SIDED|95.0|-48.3|41.5|||||Difference between GSK2894512 0.5 % QD and Vehicle QD at Week 14 has been presented.|||41.5|-48.3|
72428164|NCT02564055|144367366|OTHER||Difference in percentages|-1.0|||||TWO_SIDED|95.0|-44.5|42.7|||||Difference between GSK2894512 1 % BID and Vehicle BID at Week 16 has been presented.|||42.7|-44.5|
72428165|NCT02564055|144367366|OTHER||Difference in percentages|8.3|||||TWO_SIDED|95.0|-35.0|49.2|||||Difference between GSK2894512 1 % QD and Vehicle QD at Week 16 has been presented.|||49.2|-35.0|
72428166|NCT02564055|144367366|OTHER||Difference in percentages|-3.3|||||TWO_SIDED|95.0|-46.0|42.3|||||Difference between GSK2894512 0.5 % BID and Vehicle BID at Week 16 has been presented.|||42.3|-46.0|
72428167|NCT03268590|144367400|SUPERIORITY||||||<|0.05|TWO_SIDED|95.0|||||t-test, 2 sided|||||||<0.05
72428168|NCT03268590|144367401|SUPERIORITY||||||<|0.05|TWO_SIDED|95.0|||||t-test, 2 sided|||||||<0.05
72428169|NCT03268590|144367402|SUPERIORITY||||||<|0.05|TWO_SIDED|95.0|||||t-test, 2 sided|||||||<0.05
72428170|NCT02971891|144367431|SUPERIORITY|||||||0.1789|||||||Cochran-Mantel-Haenszel|||||||0.1789
72338438|NCT03906656|144200676|SUPERIORITY||Mean Difference (Final Values)|0.185|STANDARD_DEVIATION|53.6||0.583|TWO_SIDED|||||P-values not adjusted for multiple comparisons. P-values \< 0.05 used as threshold for statistical significance.|Wilcoxon Signed Rank Test|||H0: the median of the population differences (C-Brace - KAFO) \<= 0.|Wilcoxon Signed Rank Test. V=1207.5, effect size r = 0.026, p=0.583.|||0.583
72338439|NCT03906656|144200677|SUPERIORITY||Mean Difference (Final Values)|1.28|STANDARD_DEVIATION|4.37||0.0078|TWO_SIDED|||||P-values not adjusted for multiple comparisons. P-values \< 0.05 used as threshold for statistical significance.|Wilcoxon Signed Rank Test|||H0: the median of the population differences (C-Brace - KAFO) \<= 0. (SAI - Down)|Wilcoxon Signed Rank Test V=438, effect size r = 0.21, p=0.008|||0.0078
72428171|NCT03954158|144367478|SUPERIORITY||Least squares mean of difference|-1.6|STANDARD_ERROR_OF_MEAN|0.53||0.0071|TWO_SIDED|95.0|-2.7|-0.5|||Mixed Models Analysis|||Change at Day 15, Intra-participant: Mixed effect Model for Repeated Measures (MMRM) included the fixed effect of visit, and the covariance structure UN was used.||-0.5|-2.7|0.0071
72428172|NCT03954158|144367478|SUPERIORITY||Least squares mean of difference|-2.0|STANDARD_ERROR_OF_MEAN|0.6||0.0029|TWO_SIDED|95.0|-3.3|-0.8|||Mixed Models Analysis|||Change at Day 15, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of visit, and the covariance structure UN was used.||-0.8|-3.3|0.0029
72428173|NCT03954158|144367478|SUPERIORITY||Least squares mean of difference|-1.5|STANDARD_ERROR_OF_MEAN|0.6||0.025|TWO_SIDED|95.0|-2.7|-0.2|||Mixed Models Analysis|||Change at Day 15, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of visit, and the covariance structure UN was used.||-0.2|-2.7|0.0250
72428174|NCT03954158|144367478|SUPERIORITY||Least squares mean of difference|-2.1|STANDARD_ERROR_OF_MEAN|0.56||0.0014|TWO_SIDED|95.0|-3.3|-0.9|||Mixed Models Analysis|||Change at Day 15, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of visit, and the covariance structure UN was used.||-0.9|-3.3|0.0014
72428175|NCT03954158|144367479|OTHER||Difference of least squares mean|-0.6|STANDARD_ERROR_OF_MEAN|0.4295|||TWO_SIDED|95.0|-2.0|0.9||||||Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen, visit, dosing regimen-by-visit interaction, and baseline value and the covariance structure UN was used.||0.9|-2.0|
72428176|NCT03954158|144367479|OTHER||Difference of least squares mean|-0.8|STANDARD_ERROR_OF_MEAN|0.61|||TWO_SIDED|95.0|-2.1|0.4||||||Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen, visit, dosing regimen-by-visit interaction, and baseline value and the covariance structure UN was used.||0.4|-2.1|
72428177|NCT03954158|144367480|OTHER||Least squares mean of difference|-1.9|STANDARD_ERROR_OF_MEAN|0.56|||TWO_SIDED|95.0|-3.1|-0.7||||||Change at Day 8, Intra-participant: Mixed effect model for repeated measures included the fixed effect of visit, and the covariance structure UN was used.||-0.7|-3.1|
72428178|NCT03954158|144367480|OTHER||Least squares mean of difference|-1.4|STANDARD_ERROR_OF_MEAN|0.6|||TWO_SIDED|95.0|-2.7|-0.2||||||Change at Day 8, Intra-participant: Mixed effect model for repeated measures included the fixed effect of visit, and the covariance structure UN was used.||-0.2|-2.7|
72428179|NCT03954158|144367480|OTHER||Least squares mean of difference|-1.2|STANDARD_ERROR_OF_MEAN|0.49|||TWO_SIDED|95.0|-2.2|-0.2||||||Change at Day 8, Intra-participant: Mixed effect model for repeated measures included the fixed effect of visit, and the covariance structure UN was used.||-0.2|-2.2|
72428180|NCT03954158|144367480|OTHER||Least squares mean of difference|-1.7|STANDARD_ERROR_OF_MEAN|0.55|||TWO_SIDED|95.0|-2.8|-0.5||||||Change at Day 8, Intra-participant: Mixed effect model for repeated measures included the fixed effect of visit, and the covariance structure UN was used.||-0.5|-2.8|
72428181|NCT03954158|144367480|OTHER||Difference of least square mean|-0.1|STANDARD_ERROR_OF_MEAN|0.69|||TWO_SIDED|95.0|-1.5|1.3||||||Change at Day 8, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen, visit, dosing regimen-by-visit interaction, and baseline value and the covariance structure UN was used.||1.3|-1.5|
72428182|NCT03954158|144367480|OTHER||Difference of least square mean|-0.1|STANDARD_ERROR_OF_MEAN|0.54|||TWO_SIDED|95.0|-1.2|1.0||||||Change at Day 8, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen, visit, dosing regimen-by-visit interaction, and baseline value and the covariance structure UN was used.||1.0|-1.2|
72428183|NCT03954158|144367481|OTHER||Least squares mean of difference|-0.5|STANDARD_ERROR_OF_MEAN|0.17|||TWO_SIDED|95.0|-0.9|-0.1||||||Change at Day 8, Intra-participant: Mixed effect model for repeated measures included the fixed effect of visit, and the covariance structure UN was used.||-0.1|-0.9|
72338440|NCT03906656|144200678|SUPERIORITY||Mean Difference (Final Values)|-3.41|STANDARD_DEVIATION|17.0||0.002|TWO_SIDED|||||P-values not adjusted for multiple comparisons. P-values \< 0.05 used as threshold for statistical significance.|Wilcoxon Signed Rank Test||||Wilcoxon Signed Rank Test V=267, effect size r = 0.32, p=0.002|||0.0020
72338441|NCT03906656|144200679|SUPERIORITY||Mean Difference (Final Values)|-1.11|STANDARD_DEVIATION|3.178||0.0023|TWO_SIDED|||||P-values not adjusted for multiple comparisons. P-values \< 0.05 used as threshold for statistical significance.|Wilcoxon Signed Rank Test|||H0: the median of the population differences (C-Brace - KAFO) \<= 0. (Fear of falling - indoors)|Wilcoxon Signed Rank Test V=433, effect size r = 0.33, p=0.002|||0.0023
72428184|NCT03954158|144367481|OTHER||Least squares mean of difference|-0.4|STANDARD_ERROR_OF_MEAN|0.21|||TWO_SIDED|95.0|-0.9|0.0||||||Change at Day 8, Intra-participant: Mixed effect model for repeated measures included the fixed effect of visit, and the covariance structure UN was used.||0.0|-0.9|
72428185|NCT03954158|144367481|OTHER||Least squares mean of difference|-0.3|STANDARD_ERROR_OF_MEAN|0.23|||TWO_SIDED|95.0|-0.8|0.1||||||Change at Day 8, Intra-participant: Mixed effect model for repeated measures included the fixed effect of visit, and the covariance structure UN was used.||0.1|-0.8|
72428186|NCT03954158|144367481|OTHER||Least squares mean of difference|-0.4|STANDARD_ERROR_OF_MEAN|0.2|||TWO_SIDED|95.0|-0.8|0.0||||||Change at Day 8, Intra-participant: Mixed effect model for repeated measures included the fixed effect of visit, and the covariance structure UN was used.||0.0|-0.8|
72428187|NCT03954158|144367481|OTHER||Difference of least square mean|0.1|STANDARD_ERROR_OF_MEAN|0.27|||TWO_SIDED|95.0|-0.4|0.6||||||Change at Day 8, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen, visit, dosing regimen-by-visit interaction, and baseline value and the covariance structure UN was used.||0.6|-0.4|
72428188|NCT03954158|144367481|OTHER||Difference of least square mean|0.2|STANDARD_ERROR_OF_MEAN|0.26|||TWO_SIDED|95.0|-0.3|0.7||||||Change at Day 8, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen, visit, dosing regimen-by-visit interaction, and baseline value and the covariance structure UN was used.||0.7|-0.3|
72428189|NCT03954158|144367481|OTHER||Least squares mean of difference|-0.9|STANDARD_ERROR_OF_MEAN|0.22|||TWO_SIDED|95.0|-1.4|-0.4||||||Change at Day 15, Intra-participant: Mixed effect model for repeated measures included the fixed effect of visit, and the covariance structure UN was used.||-0.4|-1.4|
72338442|NCT03906656|144200679|SUPERIORITY||Mean Difference (Final Values)|-0.973|STANDARD_DEVIATION|3.43||0.0066|TWO_SIDED|||||P-values not adjusted for multiple comparisons. P-values \< 0.05 used as threshold for statistical significance.|Wilcoxon Signed Rank Test||||Wilcoxon Signed Rank Test V=557.5, effect size r = 0.265, p=0.0066|||0.0066
72338443|NCT03906656|144200680|SUPERIORITY|||||||0.006||||||P-value not adjusted for multiple comparisons|McNemar|||Paired dataset. H0: The probability of fallers wearing C-Brace becoming non-fallers wearing KAFO is the same as the probability of non-fallers wearing C-Brace becoming fallers wearing KAFO.||||0.006
72338444|NCT03906656|144200681|SUPERIORITY||Mean Difference (Final Values)|2.82|STANDARD_DEVIATION|16.4||0.08|TWO_SIDED|||||P-values not adjusted for multiple comparisons. P-values \< 0.05 used as threshold for statistical significance.|Wilcoxon Signed Rank Test|||H0: the median of the population differences (C-Brace - KAFO) \<= 0.|Wilcoxon Signed Rank Test. V=1325.5, effect size r = 0.181, p=0.08.|||0.08
72338445|NCT03906656|144200682|SUPERIORITY||Mean Difference (Final Values)|0.009|STANDARD_DEVIATION|0.184||0.151|TWO_SIDED|||||P-values not adjusted for multiple comparisons. P-values \< 0.05 used as threshold for statistical significance.|Wilcoxon Signed Rank Test||Wilcoxon Signed Rank Test V=1124.5, effect size r = 0.125 p=0.151|H0: the median of the population differences (C-Brace - KAFO) \<= 0||||0.151
72338446|NCT03906656|144200683|SUPERIORITY|H0: the mean of the population differences (C-Brace - KAFO) \>= 0|Mean Difference (Final Values)|-2.1|STANDARD_DEVIATION|21.5||0.281|TWO_SIDED|||||P-values not adjusted for multiple comparisons. P-values \< 0.05 used as threshold for statistical significance.|t-test, 2 sided|16.7 degrees of freedom||WLQ-25 - Physical||||0.281
72338447|NCT03906656|144200684|SUPERIORITY||Mean Difference (Final Values)|1.99|STANDARD_DEVIATION|5.18||0.00019|TWO_SIDED|||||P-values not adjusted for multiple comparisons. P-values \< 0.05 used as threshold for statistical significance.|t-test, 2 sided|48.4 degrees of freedom||OPUS - Low Extremity Functional Status. H0: the mean difference (C-Brace - KAFO) \<= 0||||0.00019
72338448|NCT03906656|144200685|SUPERIORITY||Mean Difference (Final Values)|3.19|STANDARD_DEVIATION|15.0||0.0226|TWO_SIDED|||||P-values not adjusted for multiple comparisons. P-values \< 0.05 used as threshold for statistical significance.|t-test, 2 sided|22.1 degrees of freedom||Emotional well-being. H0: the mean difference (C-Brace - KAFO) \<= 0.||||0.0226
72338449|NCT03906656|144200685|SUPERIORITY||Mean Difference (Final Values)|6.79|STANDARD_DEVIATION|21.1||0.002|TWO_SIDED|||||P-values not adjusted for multiple comparisons. P-values \< 0.05 used as threshold for statistical significance.|t-test, 2 sided|||Energy/Fatigue. H0: the mean difference (C-Brace - KAFO) \<= 0.||||0.0020
72338450|NCT03906656|144200685|SUPERIORITY||Mean Difference (Final Values)|10.1|STANDARD_DEVIATION|29.528||0.0049|TWO_SIDED|||||P-values not adjusted for multiple comparisons. P-values \< 0.05 used as threshold for statistical significance.|Wilcoxon Signed Rank Test|||Health change. H0: the median of the population differences (C-Brace - KAFO) \<= 0.|Wilcoxon Signed Rank Test. V=649, effect size r = 0.285, p=0.00493|||0.0049
72338451|NCT03906656|144200685|SUPERIORITY||Mean Difference (Final Values)|12.6|STANDARD_DEVIATION|29.2||6.47e-05|TWO_SIDED|||||P-values not adjusted for multiple comparisons. P-values \< 0.05 used as threshold for statistical significance.|t-test, 2 sided|37.35 degrees of freedom||Physical Functioning Score. H0: the mean difference (C-Brace - KAFO) \<= 0||||0.0000647
72428190|NCT03954158|144367481|OTHER||Least squares mean of difference|-0.7|STANDARD_ERROR_OF_MEAN|0.25|||TWO_SIDED|95.0|-1.2|-0.2||||||Change at Day 15, Intra-participant: Mixed effect model for repeated measures included the fixed effect of visit, and the covariance structure UN was used.||-0.2|-1.2|
72428191|NCT03954158|144367481|OTHER||Least squares mean of difference|-0.7|STANDARD_ERROR_OF_MEAN|0.24|||TWO_SIDED|95.0|-1.2|-0.2||||||Change at Day 15, Intra-participant: Mixed effect model for repeated measures included the fixed effect of visit, and the covariance structure UN was used.||-0.2|-1.2|
72428192|NCT03954158|144367481|OTHER||Least squares mean of difference|-1.0|STANDARD_ERROR_OF_MEAN|0.21|||TWO_SIDED|95.0|-1.4|-0.6||||||Change at Day 15, Intra-participant: Mixed effect model for repeated measures included the fixed effect of visit, and the covariance structure UN was used.||-0.6|-1.4|
72338452|NCT03906656|144200686|SUPERIORITY||Mean Difference (Final Values)|0.28|STANDARD_DEVIATION|0.843||0.301|TWO_SIDED|||||P-values not adjusted for multiple comparisons. P-values \< 0.05 used as threshold for statistical significance.|Wilcoxon Signed Rank Test|||Device. H0: the median of the population differences (C-Brace - KAFO) \<= 0|Wilcoxon Signed Rank Test V=1018.5, effect size r = 0.056, p=0.301|||0.301
72338453|NCT00300482|144200688|SUPERIORITY_OR_OTHER||||||<|0.001||||||alpha = 0.05, all 3 primary endpoints had to show superiority of combo therapy in order to declare combo therapy successful at a given statin dose, Hochberg method for multiple comparison adjustment for 2 statin doses|ANCOVA|||An n = 205 per arm would provide \>99% power to detect a 17% decrease in triglycerides relative to statin monotherapy for each combo therapy dose, assuming an SD of 30%||||<0.001
72338454|NCT00300482|144200688|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||alpha = 0.05, all 3 primary endpoints had to show superiority of combo therapy in order to declare combo therapy successful at a given statin dose, Hochberg method for multiple comparison adjustment for 2 statin doses|ANCOVA|||An n = 205 per arm would provide \>99% power to detect a 17% decrease in triglycerides relative to statin monotherapy for each combo therapy dose, assuming an SD of 30%||||<0.001
72338455|NCT00300482|144200689|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||alpha = 0.05, all 3 primary endpoints had to show superiority of combo therapy in order to declare combo therapy successful at a given statin dose, Hochberg method for multiple comparison adjustment for 2 statin doses|ANCOVA|||An n = 205 per arm would provide 92% power to detect a 5% increase in HDL-C relative to statin monotherapy for each combo therapy dose, assuming an SD of 15%||||<0.001
72338456|NCT00300482|144200689|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||alpha = 0.05, all 3 primary endpoints had to show superiority of combo therapy in order to declare combo therapy successful at a given statin dose, Hochberg method for multiple comparison adjustment for 2 statin doses|ANCOVA|||An n = 205 per arm would provide 92% power to detect a 5% increase in HDL-C relative to statin monotherapy for each combo therapy dose, assuming an SD of 15%||||<0.001
72338457|NCT00300482|144200690|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||alpha = 0.05, all 3 primary endpoints had to show superiority of combo therapy in order to declare combo therapy successful at a given statin dose, Hochberg method for multiple comparison adjustment for 2 statin doses|ANCOVA|||An n = 205 per arm would provide 99% power to detect a 43% decrease in LDL-C relative to ABT-335 monotherapy for each combo therapy dose, assuming an SD of 15%||||<0.001
72338458|NCT00300482|144200690|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||alpha = 0.05, all 3 primary endpoints had to show superiority of combo therapy in order to declare combo therapy successful at a given statin dose, Hochberg method for multiple comparison adjustment for 2 statin doses|ANCOVA|||An n = 205 per arm would provide 99% power to detect a 43% decrease in LDL-C relative to ABT-335 monotherapy for each combo therapy dose, assuming an SD of 15%||||<0.001
72338459|NCT00882908|144200706|SUPERIORITY_OR_OTHER||Difference in proportions of SVRW72|13.0||||0.051|TWO_SIDED|97.5|-1.9|28.0|||Regression, Logistic||Difference in percentages of participants in the TMC435 75mg and placebo groups with undetectable plasma Hepatitis C virus ribonucleic acid levels at end of treatment (EOT) and at Week 72 estimated from the logistic regression model.|TMC435 75 mg 12 and 24 week treatment groups were pooled and the percentage of participants acheiving SVRW72 were compared with the percentage of participants acheiving SVRW72 in the placebo treatment group.||28.0|-1.9|0.051
72338460|NCT00882908|144200706|SUPERIORITY_OR_OTHER||Difference in proportions of SVRW72|18.9||||0.004|TWO_SIDED|97.5|4.4|33.5|||Regression, Logistic||Difference in percentages of participants in the TMC435 150mg and placebo groups with undetectable plasma Hepatitis C virus ribonucleic acid levels at end of treatment (EOT) and at Week 72 estimated from the logistic regression model.|TMC/PR 150 mg 12 and 24 week treatment groups were pooled and the percentage of participants achieving SVRW72 was compared the percentage of participants achieving SVRW72 in the placebo treatment group.||33.5|4.4|0.004
72338461|NCT02370095|144200721|SUPERIORITY|||||||0.2416|||||||Wilcoxon (Mann-Whitney)|||Only one placebo subject had data to allow for change from baseline to be calculated||||0.2416
72338462|NCT02370095|144200722|SUPERIORITY|||||||0.06|||||||Mixed Models Analysis|The change in S/F ratio over time was evaluated using a mixed model for repeated measures||||||0.06
72428193|NCT03954158|144367481|OTHER||Difference of least square mean|0.0|STANDARD_ERROR_OF_MEAN|0.27|||TWO_SIDED|95.0|-0.5|0.6||||||Change at Day 15, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen, visit, dosing regimen-by-visit interaction, and baseline value and the covariance structure UN was used.||0.6|-0.5|
72338463|NCT02370095|144200723|SUPERIORITY|||||||0.0679|||||||Wilcoxon (Mann-Whitney)|||||||0.0679
72338464|NCT02370095|144200728|SUPERIORITY|||||||0.567|||||||Mixed Models Analysis|Measurement of MAP were evaluated from baseline to end of treatment||||||0.567
72338465|NCT02370095|144200729|SUPERIORITY|||||||0.2507||||||The threshold for statistical significance was 0.05|Fisher Exact|||||||0.2507
72338466|NCT02370095|144200731|SUPERIORITY|||||||0.5055|||||||Fisher Exact|||||||0.5055
72338467|NCT02130986|144200745|SUPERIORITY||Mean Difference (Net)|-0.05||||0.87|TWO_SIDED||||||t-test, 2 sided|||||||0.87
72338468|NCT02130986|144200746|NON_INFERIORITY|Procalcitonin algorithm implementation increases or does not change the proportion of subjects who experience a composite endpoint of adverse outcomes by Day 30. The prespecified noninferiority margin is 4.5 percentage.|Risk Difference (RD)|-0.015|||<|0.001|TWO_SIDED||||||Chi-squared|||||||<0.001
72338469|NCT02130986|144200747|SUPERIORITY||Risk Difference (RD)|-4.6|||||TWO_SIDED|95.0|-12.2|30.0||||||||30|-12.2|
72338470|NCT01735708|144200763|SUPERIORITY|ITT analysis using multiple imputation by chained equation with 50 fully populated data sets.|Mean Difference (Net)|-1.31|STANDARD_ERROR_OF_MEAN|0.493||0.008|TWO_SIDED|95.0|-2.28|-0.34||A priori threshold for significance was two-tailed p = .05.|Mixed Models Analysis|Standard errors were based on robust Huber-White variance estimator.|standard error of difference in means|||-0.34|-2.28|0.008
72338471|NCT01735708|144200764|SUPERIORITY|Intent to treat analysis using multiple imputation by chained equations with 50 fully populated data sets.|Mean Difference (Net)|-0.57|STANDARD_ERROR_OF_MEAN|0.495||0.251|TWO_SIDED|95.0|-1.53|0.4||A priori threshold for significance was two-tailed p = .05.|Mixed Models Analysis|Standard errors were based on robust Huber-White variance estimator.||||0.40|-1.53|0.251
72338472|NCT01735708|144200765|SUPERIORITY|Intent to treat analysis using multiple imputation by chained equations with 50 fully populated data sets.|Mean Difference (Net)|0.15|STANDARD_ERROR_OF_MEAN|0.75||0.844|TWO_SIDED|95.0|-1.32|1.61||A priori threshold for significance was two-tailed p = .05.|Mixed Models Analysis|Standard errors were based on robust Huber-White variance estimator.|Standard error of difference in means.|||1.61|-1.32|0.844
72428194|NCT03954158|144367481|OTHER||Difference of least square mean|-0.1|STANDARD_ERROR_OF_MEAN|0.28|||TWO_SIDED|95.0|-0.7|0.5||||||Change at Day 15, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen, visit, dosing regimen-by-visit interaction, and baseline value and the covariance structure UN was used.||0.5|-0.7|
72428195|NCT03954158|144367482|OTHER||Least squares mean of difference|-0.6|STANDARD_ERROR_OF_MEAN|0.2|||TWO_SIDED|95.0|-1.0|-0.2||||||Change at Day 2, Intra-participant: Mixed effect model for repeated measures included the fixed effect of day, and the covariance structure UN was used.||-0.2|-1.0|
72338473|NCT01735708|144200766|SUPERIORITY|Intent to treat analysis using multiple imputation by chained equations with 50 fully populated data sets.|Mean Difference (Final Values)|-0.51|STANDARD_ERROR_OF_MEAN|0.836||0.545|TWO_SIDED|95.0|-2.18|1.15||A priori threshold for significance was two-tailed p = .05.|Mixed Models Analysis|Standard errors were based on robust Huber-White variance estimator.|Standard error of difference in means.|||1.15|-2.18|0.545
72338474|NCT00259298|144200815|SUPERIORITY_OR_OTHER|||||||0.0078||95.0||||p-value is for skull, baseline to 3 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal plasma clearance of 99m Tc-MDP in the skull from baseline to 3 months.||||0.0078
72338475|NCT00259298|144200815|SUPERIORITY_OR_OTHER|||||||0.0078||95.0||||p-value is for skull, baseline to 18 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal plasma clearance of 99m Tc-MDP in the skull from baseline to 18 months.||||0.0078
72338476|NCT00259298|144200815|SUPERIORITY_OR_OTHER|||||||0.0313||95.0||||p-value is for skull, baseline to 24 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no change in skeletal plasma clearance of 99m Tc-MDP in the skull from baseline to 24 months.||||0.0313
72338477|NCT00259298|144200815|SUPERIORITY_OR_OTHER|||||||0.0078||95.0||||p-value is for skull, 3 months to 18 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal plasma clearance of 99m Tc-MDP in the skull from 3 months to 18 months.||||0.0078
72338478|NCT00259298|144200815|SUPERIORITY_OR_OTHER|||||||0.0156||95.0||||p-value is for skull, 18 months to 24 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no decrease in skeletal plasma clearance of 99m Tc-MDP in the skull from 18 months to 24 months.||||0.0156
72338479|NCT00259298|144200815|SUPERIORITY_OR_OTHER|||||||0.0156||95.0||||p-value is for mandible, baseline to 3 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal plasma clearance of 99m Tc-MDP in the mandible from baseline to 3 months.||||0.0156
72338480|NCT00259298|144200815|SUPERIORITY_OR_OTHER|||||||0.0078||95.0||||p-value is for mandible, baseline to 18 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal plasma clearance of 99m Tc-MDP in the mandible from baseline to 18 months.||||0.0078
72338481|NCT00259298|144200815|SUPERIORITY_OR_OTHER|||||||0.1563||95.0||||p-value is for mandible, baseline to 24 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no change in skeletal plasma clearance of 99m Tc-MDP in the mandible from baseline to 24 months.||||0.1563
72428196|NCT03954158|144367482|OTHER||Least squares mean of difference|-0.1|STANDARD_ERROR_OF_MEAN|0.28|||TWO_SIDED|95.0|-0.7|0.5||||||Change at Day 2, Intra-participant: Mixed effect model for repeated measures included the fixed effect of day, and the covariance structure UN was used.||0.5|-0.7|
72338482|NCT00259298|144200815|SUPERIORITY_OR_OTHER|||||||0.4375||95.0||||p-value is for mandible, 3 months to 18 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal plasma clearance of 99m Tc-MDP in the mandible from 3 months to 18 months.||||0.4375
72338483|NCT00259298|144200815|SUPERIORITY_OR_OTHER|||||||0.0781||95.0||||p-value is for mandible, 18 months to 24 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no decrease in skeletal plasma clearance of 99m Tc-MDP in the mandible from 18 months to 24 months.||||0.0781
72338484|NCT00259298|144200815|SUPERIORITY_OR_OTHER|||||||0.0371||95.0||||p-value is for spine, baseline to 3 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal plasma clearance of 99m Tc-MDP in the spine from baseline to 3 months.||||0.0371
72338485|NCT00259298|144200815|SUPERIORITY_OR_OTHER|||||||0.0137||95.0||||p-value is for spine, baseline to 18 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal plasma clearance of 99m Tc-MDP in the spine from baseline to 18 months.||||0.0137
72338486|NCT00259298|144200815|SUPERIORITY_OR_OTHER|||||||0.0547||95.0||||p-value is for spine, baseline to 24 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no change in skeletal plasma clearance of 99m Tc-MDP in the spine from baseline to 24 months.||||0.0547
72338487|NCT00259298|144200815|SUPERIORITY_OR_OTHER|||||||0.0488||95.0||||p-value is for spine, 3 months to 18 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal plasma clearance of 99m Tc-MDP in the spine from 3 months to 18 months.||||0.0488
72338488|NCT00259298|144200815|SUPERIORITY_OR_OTHER|||||||0.3594||95.0||||p-value is for spine, 18 months to 24 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no decrease in skeletal plasma clearance of 99m Tc-MDP in the spine from 18 months to 24 months.||||0.3594
72338489|NCT00259298|144200815|SUPERIORITY_OR_OTHER|||||||0.0488||95.0||||p-value is for pelvis, baseline to 3 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal plasma clearance of 99m Tc-MDP in the pelvis from baseline to 3 months.||||0.0488
72338490|NCT00259298|144200815|SUPERIORITY_OR_OTHER|||||||0.1055||95.0||||p-value is for pelvis, baseline to 18 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal plasma clearance of 99m Tc-MDP in the pelvis from baseline to 18 months.||||0.1055
72338491|NCT00259298|144200815|SUPERIORITY_OR_OTHER|||||||0.9102||95.0||||p-value is for pelvis, baseline to 24 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no change in skeletal plasma clearance of 99m Tc-MDP in the pelvis from baseline to 24 months.||||0.9102
72338492|NCT00259298|144200815|SUPERIORITY_OR_OTHER|||||||0.1934||95.0||||p-value is for pelvis, 3 months to 18 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal plasma clearance of 99m Tc-MDP in the pelvis from 3 months to 18 months.||||0.1934
72338493|NCT00259298|144200815|SUPERIORITY_OR_OTHER|||||||0.1641||95.0||||p-value is for pelvis, 18 months to 24 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no decrease in skeletal plasma clearance of 99m Tc-MDP in the pelvis from 18 months to 24 months.||||0.1641
72338494|NCT00259298|144200815|SUPERIORITY_OR_OTHER|||||||0.0137||95.0||||p-value is for upper extremities, baseline to 3 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal plasma clearance of 99m Tc-MDP in the upper extremities from baseline to 3 months.||||0.0137
72428197|NCT03954158|144367482|OTHER||Difference of least squares mean|0.6|STANDARD_ERROR_OF_MEAN|0.54|||TWO_SIDED|95.0|-0.5|1.7||||||Change at Day 2, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen, day, dosing regimen-by-day interaction, and baseline value and the covariance structure UN was used.||1.7|-0.5|
72338495|NCT00259298|144200815|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||p-value is for upper extremities, baseline to 18 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal plasma clearance of 99m Tc-MDP in the upper extremities from baseline to 18 months.||||0.0020
72338496|NCT00259298|144200815|SUPERIORITY_OR_OTHER|||||||0.0039||95.0||||p-value is for upper extremities, baseline to 24 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no change in skeletal plasma clearance of 99m Tc-MDP in the upper extremities from baseline to 24 months.||||0.0039
72338497|NCT00259298|144200815|SUPERIORITY_OR_OTHER|||||||0.0273||95.0||||p-value is for upper extremities, 3 months to 18 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal plasma clearance of 99m Tc-MDP in the upper extremities from 3 months to 18 months.||||0.0273
72338498|NCT00259298|144200815|SUPERIORITY_OR_OTHER|||||||0.0547||95.0||||p-value is for upper extremities, 18 months to 24 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no decrease in skeletal plasma clearance of 99m Tc-MDP in the upper extremities from 18 months to 24 months.||||0.0547
72338499|NCT00259298|144200815|SUPERIORITY_OR_OTHER|||||||0.0195||95.0||||p-value is for lower extremities, baseline to 3 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal plasma clearance of 99m Tc-MDP in the lower extremities from baseline to 3 months.||||0.0195
72338500|NCT00259298|144200815|SUPERIORITY_OR_OTHER|||||||0.0059||95.0||||p-value is for lower extremities, baseline to 18 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal plasma clearance of 99m Tc-MDP in the lower extremities from baseline to 18 months.||||0.0059
72338501|NCT00259298|144200815|SUPERIORITY_OR_OTHER|||||||0.5703||95.0||||p-value is for lower extremities, baseline to 24 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no change in skeletal plasma clearance of 99m Tc-MDP in the lower extremities from baseline to 24 months.||||0.5703
72338502|NCT00259298|144200815|SUPERIORITY_OR_OTHER|||||||0.1934||95.0||||p-value is for lower extremities, 3 months to 18 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal plasma clearance of 99m Tc-MDP in the lower extremities from 3 months to 18 months.||||0.1934
72338503|NCT00259298|144200815|SUPERIORITY_OR_OTHER|||||||0.0039||95.0||||p-value is for lower extremities, 18 months to 24 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no decrease in skeletal plasma clearance of 99m Tc-MDP in the lower extremities from 18 months to 24 months.||||0.0039
72338504|NCT00259298|144200815|SUPERIORITY_OR_OTHER|||||||0.0039||95.0||||p-value is for whole body, baseline to 3 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal plasma clearance of 99m Tc-MDP in the whole body from baseline to 3 months.||||0.0039
72338505|NCT00259298|144200815|SUPERIORITY_OR_OTHER|||||||0.5703||95.0||||p-value is for whole body, baseline to 24 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no change in skeletal plasma clearance of 99m Tc-MDP in the whole body from baseline to 24 months.||||0.5703
72338506|NCT00259298|144200815|SUPERIORITY_OR_OTHER|||||||0.0273||95.0||||p-value is for whole body, 3 months to 18 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal plasma clearance of 99m Tc-MDP in the whole body from 3 months to 18 months.||||0.0273
72338507|NCT00259298|144200815|SUPERIORITY_OR_OTHER|||||||0.0039||95.0||||p-value if for whole body, 18 months to 24 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no decrease in skeletal plasma clearance of 99m Tc-MDP in the whole body from 18 months to 24 months.||||0.0039
72338508|NCT00259298|144200816|SUPERIORITY_OR_OTHER|||||||0.0098||95.0||||p-value is for whole skeleton, baseline to 3 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal uptake of 99m Tc-MDP in the whole skeleton from baseline to 3 months.||||0.0098
72338509|NCT00259298|144200816|SUPERIORITY_OR_OTHER|||||||0.0039||95.0||||p-value is for whole skeleton, baseline to 18 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal uptake of 99m Tc-MDP in the whole skeleton from baseline to 18 months.||||0.0039
72338510|NCT00259298|144200816|SUPERIORITY_OR_OTHER|||||||0.6523||95.0||||p-value is for whole skeleton, baseline to 24 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal uptake of 99m Tc-MDP in the whole skeleton from baseline to 24 months.||||0.6523
72338511|NCT00259298|144200816|SUPERIORITY_OR_OTHER|||||||0.1641||95.0||||p-value is for whole skeleton, 3 months to 18 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal uptake of 99m Tc-MDP in the whole skeleton from 3 months to 18 months.||||0.1641
72338512|NCT00259298|144200816|SUPERIORITY_OR_OTHER|||||||0.0078||95.0||||p-value is for whole skeleton, 18 months to 24 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal uptake of 99m Tc-MDP in the whole skeleton from 18 months to 24 months.||||0.0078
72338513|NCT00259298|144200816|SUPERIORITY_OR_OTHER|||||||0.0078||95.0||||p-value is for skull, baseline to 3 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal uptake of 99m Tc-MDP in the skull from baseline to 3 months.||||0.0078
72338514|NCT00259298|144200816|SUPERIORITY_OR_OTHER|||||||0.0078||95.0||||p-value is for skull, baseline to 18 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal uptake of 99m Tc-MDP in the skull from baseline to 18 months.||||0.0078
72338515|NCT00259298|144200816|SUPERIORITY_OR_OTHER|||||||0.0781||95.0||||p-value is for skull, baseline to 24 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no change in skeletal uptake of 99m Tc-MDP in the skull from baseline to 24 months.||||0.0781
72338516|NCT00259298|144200816|SUPERIORITY_OR_OTHER|||||||0.0078||95.0||||p-value is for skull, 3 months to 18 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal uptake of 99m Tc-MDP in the skull from 3 months to 18 months.||||0.0078
72338517|NCT00259298|144200816|SUPERIORITY_OR_OTHER|||||||0.0156||95.0||||p-value is for skull, 18 months to 24 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no decrease in skeletal uptake of 99m Tc-MDP in the skull from 18 months to 24 months.||||0.0156
72338518|NCT00259298|144200816|SUPERIORITY_OR_OTHER|||||||0.0391||95.0||||p-value is for mandible, baseline to 3 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal uptake of 99m Tc-MDP in the mandible from baseline to 3 months.||||0.0391
72338519|NCT00259298|144200816|SUPERIORITY_OR_OTHER|||||||0.0313||95.0||||p-value is for mandible, baseline to 18 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal uptake of 99m Tc-MDP in the mandible from baseline to 18 months.||||0.0313
72338520|NCT00259298|144200816|SUPERIORITY_OR_OTHER|||||||0.2969||95.0||||p-value is for mandible, baseline to 24 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal uptake of 99m Tc-MDP in the mandible from baseline to 24 months.||||0.2969
72338521|NCT00259298|144200816|SUPERIORITY_OR_OTHER|||||||0.5625||95.0||||p-value is for mandible, 3 months to 18 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal uptake of 99m Tc-MDP in the mandible from 3 months to 18 months.||||0.5625
72338522|NCT00259298|144200816|SUPERIORITY_OR_OTHER|||||||0.0469||95.0||||p-value is for mandible, 18 months to 24 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no decrease in skeletal uptake of 99m Tc-MDP in the mandible from 18 months to 24 months.||||0.0469
72338523|NCT00259298|144200816|SUPERIORITY_OR_OTHER|||||||0.1934||95.0||||p-value is for spine, 3 months to 18 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal uptake of 99m Tc-MDP in the spine from 3 months to 18 months.||||0.1934
72338524|NCT00259298|144200816|SUPERIORITY_OR_OTHER|||||||0.2324||95.0||||p-value is for spine, baseline to 3 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal uptake of 99m Tc-MDP in the spine from baseline to 3 months.||||0.2324
72338525|NCT00259298|144200816|SUPERIORITY_OR_OTHER|||||||0.0645||95.0||||p-value is for spine, baseline to 18 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal uptake of 99m Tc-MDP in the spine from baseline to 18 months.||||0.0645
72338526|NCT00259298|144200816|SUPERIORITY_OR_OTHER|||||||0.0273||95.0||||p-value is for spine, baseline to 24 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no change in skeletal uptake of 99m Tc-MDP in the spine from baseline to 24 months.||||0.0273
72338527|NCT00259298|144200816|SUPERIORITY_OR_OTHER|||||||0.7344||95.0||||p-value is for spine, 18 months to 24 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no decrease in skeletal uptake of 99m Tc-MDP in the spine from 18 months to 24 months.||||0.7344
72338528|NCT00259298|144200816|SUPERIORITY_OR_OTHER|||||||0.1934||95.0||||p-value is for pelvis, baseline to 3 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal uptake of 99m Tc-MDP in the pelvis from baseline to 3 months.||||0.1934
72338529|NCT00259298|144200816|SUPERIORITY_OR_OTHER|||||||0.7695||95.0||||p-value is for pelvis, baseline to 18 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal uptake of 99m Tc-MDP in the pelvis from baseline to 18 months.||||0.7695
72338530|NCT00259298|144200816|SUPERIORITY_OR_OTHER|||||||0.6523||95.0||||p-value is for pelvis, baseline to 24 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal uptake of 99m Tc-MDP in the pelvis from baseline to 24 months.||||0.6523
72338531|NCT00259298|144200816|SUPERIORITY_OR_OTHER|||||||0.2324||95.0||||p-value is for pelvis, 3 months to 18 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal uptake of 99m Tc-MDP in the pelvis from 3 months to 18 months.||||0.2324
72338532|NCT00259298|144200816|SUPERIORITY_OR_OTHER|||||||0.6523||95.0||||p-value is for pelvis, 18 months to 24 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no decrease in skeletal uptake of 99m Tc-MDP in the pelvis from 18 months to 24 months.||||0.6523
72338533|NCT00259298|144200816|SUPERIORITY_OR_OTHER|||||||0.0098||95.0||||p-value is for upper extremities, baseline to 3 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal uptake of 99m Tc-MDP in the upper extremities from baseline to 3 months.||||0.0098
72338534|NCT00259298|144200816|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||p-value is for upper extremities, baseline to 18 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal uptake of 99m Tc-MDP in the upper extremities from baseline to 18 months.||||0.0020
72338535|NCT00259298|144200816|SUPERIORITY_OR_OTHER|||||||0.0039||95.0||||p-value is for upper extremities, baseline to 24 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal uptake of 99m Tc-MDP in the upper extremities from baseline to 24 months.||||0.0039
72338536|NCT00259298|144200816|SUPERIORITY_OR_OTHER|||||||0.0273||95.0||||p-value is for upper extremities, 3 months to 18 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal uptake of 99m Tc-MDP in the upper extremities from 3 months to 18 months.||||0.0273
72338537|NCT00259298|144200816|SUPERIORITY_OR_OTHER|||||||0.3594||95.0||||p-value is for upper extremities, 18 months to 24 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no decrease in skeletal uptake of 99m Tc-MDP in the upper extremities from 18 months to 24 months.||||0.3594
72338538|NCT00259298|144200816|SUPERIORITY_OR_OTHER|||||||0.0371||95.0||||p-value is for lower extremities, baseline to 3 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal uptake of 99m Tc-MDP in the lower extremities from baseline to 3 months.||||0.0371
72338539|NCT00259298|144200816|SUPERIORITY_OR_OTHER|||||||0.0098||95.0||||p-value is for lower extremities, baseline to 18 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal uptake of 99m Tc-MDP in the lower extremities from baseline to 18 months.||||0.0098
72338540|NCT00259298|144200816|SUPERIORITY_OR_OTHER|||||||0.4609||95.0||||p-value is for lower extremities, baseline to 24 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal uptake of 99m Tc-MDP in the lower extremities from baseline to 24 months.||||0.4609
72338541|NCT00259298|144200816|SUPERIORITY_OR_OTHER|||||||0.1934||95.0||||p-value is for lower extremities, 3 months to 18 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal uptake of 99m Tc-MDP in the lower extremities from 3 months to 18 months.||||0.1934
72428198|NCT03954158|144367482|OTHER||Least squares mean of difference|-0.6|STANDARD_ERROR_OF_MEAN|0.32|||TWO_SIDED|95.0|-1.3|0.1||||||Change at Day 3, Intra-participant: Mixed effect model for repeated measures included the fixed effect of day, and the covariance structure UN was used.||0.1|-1.3|
72428199|NCT03954158|144367482|OTHER||Least squares mean of difference|-0.2|STANDARD_ERROR_OF_MEAN|0.32|||TWO_SIDED|95.0|-0.9|0.4||||||Change at Day 3, Intra-participant: Mixed effect model for repeated measures included the fixed effect of day, and the covariance structure UN was used.||0.4|-0.9|
72338542|NCT00259298|144200816|SUPERIORITY_OR_OTHER|||||||0.0273||95.0||||p-value is for lower extremities, 18 months to 24 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no decrease in skeletal uptake of 99m Tc-MDP in the lower extremities from 18 months to 24 months.||||0.0273
72338543|NCT00259298|144200817|SUPERIORITY_OR_OTHER|||||||1||95.0||||p-value is for focal change, baseline to 3 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in focal skeletal uptake of 99m Tc-MDP from baseline to 3 months.||||1.0
72338544|NCT00259298|144200817|SUPERIORITY_OR_OTHER|||||||1||95.0||||p-value is for focal change, baseline to 18 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in focal skeletal uptake of 99m Tc-MDP from baseline to 18 months.||||1.0
72338545|NCT00259298|144200819|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||p-value is for change at 18 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in whole skeletal plasma clearance of 99m Tc-MDP from baseline to 18 months.||||0.0020
72338546|NCT01498185|144200832|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.5|STANDARD_ERROR_OF_MEAN|18.5425|||TWO_SIDED|95.0|-40.85|35.86||No formal statistical testing was performed to compare between treatment groups.|Descriptive statistics|||||35.86|-40.85|
72338547|NCT01498185|144200832|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.77|STANDARD_ERROR_OF_MEAN|16.7228|||TWO_SIDED|95.0|-35.36|33.82||No formal statistical testing was performed to compare between treatment groups.|Descriptive statistics|||||33.82|-35.36|
72338548|NCT01498185|144200832|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.88|STANDARD_ERROR_OF_MEAN|17.1548|||TWO_SIDED|95.0|-42.21|28.45||No formal statistical testing was performed to compare between treatment groups.|Descriptive statistics|||||28.45|-42.21|
72338549|NCT01498185|144200832|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.03|STANDARD_ERROR_OF_MEAN|18.4617|||TWO_SIDED|95.0|-39.22|37.16||No formal statistical testing was performed to compare between treatment groups.|Descriptive statistics|||||37.16|-39.22|
72338550|NCT01071356|144200873|SUPERIORITY_OR_OTHER||Time averaged post-bline diff in diff|-0.006||||0.47|TWO_SIDED|95.0|-0.023|0.011|||Random Effects modeling||Stat Mixed Model: MI9 (Post - Bline) - MI1 (Post - Bline) taken across 2, 4, and 6 month follow-ups adjusted for gender, age, and # sessions attended.|Stat Mixed Model Estimated was: MI9 (Post - Bline) - MI1 (Post - Bline) taken across 2, 4, and 6 month follow-ups adjusted for gender, age, and # sessions attended. This was done because a statistical test of trend of the post-baseline effect across the 3 post interviews indicated a homogeneous post-baseline treatment effect across time for both MI1 and MI9 conditions.||.011|-.023|.47
72338551|NCT01071356|144200874|SUPERIORITY_OR_OTHER||Time averaged post-bline diff in diff|0.007||||0.034|TWO_SIDED|95.0|0.001|0.013|||Random effects model||Stat Mixed Model: MI9 (Post - Bline) - MI1 (Post - Bline) taken across 2, 4, and 6 month follow-ups adjusted for gender, age, and # sessions attended.|Stat Mixed Model Estimated was: MI9 (Post - Bline) - MI1 (Post - Bline) taken across 2, 4, and 6 month follow-ups adjusted for gender, age, and # sessions attended. This was done because a statistical test of trend of the post-baseline effect across the 3 post interviews indicated a homogeneous post-baseline treatment effect across time for both MI1 and MI9 conditions.||.013|.001|.034
72338552|NCT00131456|144200880|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED|95.0|||||Regression, Logistic|||Logistic regression was used to analyze all dichotomous outcomes. The dichotomous primary outcome marijuana abstinence was modeled using independent predictors: treatment(Venlafaxine vs. Placebo) and baseline urine THC level. The initial analysis included an interaction between treatment and baseline urine THC levels which was deemed not significant and omitted from the final logistic model.||||<0.01
72338553|NCT00262847|144200881|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.954||||0.448||95.0|0.844|1.078|||Regression, Cox|Proportional Hazards model stratified by stage of disease and size of residual disease following initial staging surgery.||||1.078|0.844|0.448
72338554|NCT00262847|144200881|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.765|||<|0.001||95.0|0.676|0.866|||Regression, Cox|Proportional Hazards model stratified by stage of disease and size of residual disease following initial staging surgery.||||0.866|0.676|<0.001
72338555|NCT00262847|144200882|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.069||||0.41||95.0|0.912|1.255|||Regression, Cox|Proportional Hazards model stratified by stage of disease and size of residual disease following initial staging surgery.||||1.255|0.912|0.410
72338556|NCT00262847|144200882|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.88||||0.131||95.0|0.746|1.039|||Regression, Cox|Proportional Hazards model stratified by stage of disease and size of residual disease following initial staging surgery.||||1.039|0.746|0.131
72338557|NCT03880838|144200893|SUPERIORITY||Slope|-0.06|STANDARD_ERROR_OF_MEAN|0.07||0.391|TWO_SIDED||||||Regression, Linear|||In this contrast, letter was compared against all other conditions (coded into one category and set as the reference group). The key outcome is the interaction between conditions and time (2019 as the reference group).||||.391
72338558|NCT03880838|144200893|SUPERIORITY||Slope|-0.01|STANDARD_ERROR_OF_MEAN|0.07||0.861|TWO_SIDED||||||Regression, Linear|||In this contrast, no contact control was compared against all other conditions (coded into one category and set as the reference group). The key outcome is the interaction between conditions and time (2019 as the reference group).||||.861
72338559|NCT03880838|144200893|SUPERIORITY||Slope|-0.02|STANDARD_DEVIATION|0.01||0.835|TWO_SIDED||||||Regression, Linear|||In this contrast, prevention conditions (coded into one category) were compared against no nudge conditions (coded into one category and set as the reference group).||||.835
72338560|NCT03880838|144200893|SUPERIORITY||Slope|0.02|STANDARD_ERROR_OF_MEAN|0.01||0.877|TWO_SIDED||||||Regression, Linear|||In this contrast, commitment conditions (coded into one category) were compared against no nudge conditions (coded into one category and set as the reference group).||||.877
72338561|NCT03880838|144200893|SUPERIORITY||Slope|0.004|STANDARD_ERROR_OF_MEAN|0.01||0.969|TWO_SIDED||||||Regression, Logistic|||In this contrast, both nudge conditions (coded into one category) were compared against no nudge conditions (coded into one category and set as the reference group).||||.969
72338562|NCT03880838|144200893|SUPERIORITY||Slope|0.06|STANDARD_ERROR_OF_MEAN|0.09||0.893|TWO_SIDED||||||Regression, Linear|||In this contrast, no nudge conditions (coded into one category) were compared against the letter condition (set as the reference group).||||.893
72338563|NCT03880838|144200893|SUPERIORITY||Slope|0.04|STANDARD_ERROR_OF_MEAN|0.1||0.689|TWO_SIDED||||||Regression, Linear|||In this contrast, In this contrast, prevention conditions (coded into one category) were compared against the letter condition (set as the reference group).||||.689
72338564|NCT03880838|144200893|SUPERIORITY||Slope|0.08|STANDARD_ERROR_OF_MEAN|0.1||0.427|TWO_SIDED||||||Regression, Linear|||In this contrast, commitment conditions (coded into one category) were compared against the letter condition (set as the reference group).||||.427
72338565|NCT03880838|144200893|SUPERIORITY||Slope|0.07|STANDARD_ERROR_OF_MEAN|0.1||0.504|TWO_SIDED||||||Regression, Linear|||In this contrast, both nudge conditions (coded into one category) were compared against the letter condition (set as the reference group).||||.504
72338566|NCT03880838|144200893|SUPERIORITY||Slope|0.01|STANDARD_ERROR_OF_MEAN|0.09||0.893|TWO_SIDED||||||Regression, Linear|||In this contrast, no nudge conditions (coded into one category) were compared against the no contact condition (set as the reference group).||||.893
72338567|NCT03880838|144200893|SUPERIORITY||Slope|-0.01|STANDARD_ERROR_OF_MEAN|0.09||0.918|TWO_SIDED||||||Regression, Linear|||In this contrast, prevention conditions (coded into one category) were compared against the no contact condition (set as the reference group).||||.918
72338568|NCT03880838|144200893|SUPERIORITY||Slope|0.03|STANDARD_ERROR_OF_MEAN|0.09||0.755|TWO_SIDED||||||Regression, Linear|||In this contrast, commitment conditions (coded into one category) were compared against the no contact condition (set as the reference group).||||.755
72338569|NCT03880838|144200893|SUPERIORITY||Slope|0.02|STANDARD_ERROR_OF_MEAN|0.09||0.858|TWO_SIDED||||||Regression, Linear|||In this contrast, both nudge conditions (coded into one category) were compared against the no contact condition (set as the reference group).||||.858
72338570|NCT03880838|144200894|SUPERIORITY||Slope|0.36|STANDARD_ERROR_OF_MEAN|0.46||0.436|TWO_SIDED||||||Regression, Linear|||In this contrast, letter was compared against all other conditions (coded into one category and set as the reference group). The key outcome is the interaction between conditions and time (2019 as the reference group).||||.436
72338571|NCT03880838|144200894|SUPERIORITY||Slope|-0.27|STANDARD_ERROR_OF_MEAN|0.45||0.539|TWO_SIDED||||||Regression, Linear|||In this contrast, no contact control was compared against all other conditions (coded into one category and set as the reference group). The key outcome is the interaction between conditions and time (2019 as the reference group).||||.539
72338572|NCT03880838|144200894|SUPERIORITY||Slope|0.005|STANDARD_ERROR_OF_MEAN|0.66||0.994|TWO_SIDED||||||Regression, Linear|||In this contrast, prevention conditions (coded into one category) were compared against no nudge conditions (coded into one category and set as the reference group).||||.994
72338573|NCT03880838|144200894|SUPERIORITY||Slope|-0.25|STANDARD_ERROR_OF_MEAN|0.66||0.7|TWO_SIDED||||||Regression, Linear|||In this contrast, commitment conditions (coded into one category) were compared against no nudge conditions (coded into one category and set as the reference group).||||.700
72338574|NCT03880838|144200894|SUPERIORITY||Slope|0.75|STANDARD_ERROR_OF_MEAN|0.66||0.258|TWO_SIDED||||||Regression, Logistic|||In this contrast, both nudge conditions (coded into one category) were compared against no nudge conditions (coded into one category and set as the reference group).||||.258
72338575|NCT03880838|144200894|SUPERIORITY||Slope|-0.49|STANDARD_ERROR_OF_MEAN|0.62||0.428|TWO_SIDED||||||Regression, Linear|||In this contrast, no nudge conditions (coded into one category) were compared against the letter condition (set as the reference group).||||.428
72338576|NCT03880838|144200894|SUPERIORITY||Slope|-0.48|STANDARD_ERROR_OF_MEAN|0.62||0.434|TWO_SIDED||||||Regression, Linear|||In this contrast, prevention conditions (coded into one category) were compared against the letter condition (set as the reference group).||||.434
72338577|NCT03880838|144200894|SUPERIORITY||Slope|-0.74|STANDARD_ERROR_OF_MEAN|0.62||0.228|TWO_SIDED||||||Regression, Linear|||In this contrast, commitment conditions (coded into one category) were compared against the letter condition (set as the reference group).||||.228
72338578|NCT03880838|144200894|SUPERIORITY||Slope|0.26|STANDARD_ERROR_OF_MEAN|0.62||0.674|TWO_SIDED||||||Regression, Linear|||In this contrast, both nudge conditions (coded into one category) were compared against the letter condition (set as the reference group).||||.674
72338579|NCT03880838|144200894|SUPERIORITY||Slope|0.15|STANDARD_ERROR_OF_MEAN|0.61||0.799|TWO_SIDED||||||Regression, Linear|||In this contrast, no nudge conditions (coded into one category) were compared against the no contact condition (set as the reference group).||||.799
72338580|NCT03880838|144200894|SUPERIORITY||Slope|0.16|STANDARD_ERROR_OF_MEAN|0.61||0.794|TWO_SIDED||||||Regression, Linear|||In this contrast, prevention conditions (coded into one category) were compared against the no contact condition (set as the reference group).||||.794
72338581|NCT03880838|144200894|SUPERIORITY||Slope|-0.1|STANDARD_ERROR_OF_MEAN|0.61||0.871|TWO_SIDED||||||Regression, Linear|||In this contrast, commitment conditions (coded into one category) were compared against the no contact condition (set as the reference group).||||.871
72338582|NCT03880838|144200894|SUPERIORITY||Slope|0.9|STANDARD_ERROR_OF_MEAN|0.62||0.139|TWO_SIDED||||||Regression, Linear|||In this contrast, both nudge conditions (coded into one category) were compared against the no contact condition (set as the reference group).||||.139
72338583|NCT03880838|144200895|SUPERIORITY||Slope|0.26|STANDARD_ERROR_OF_MEAN|0.29||0.357|TWO_SIDED||||||Regression, Linear|||In this contrast, letter was compared against all other conditions (coded into one category and set as the reference group). The key outcome is the interaction between conditions and time (2019 as the reference group).||||.357
72338584|NCT03880838|144200895|SUPERIORITY||Slope|-0.29|STANDARD_ERROR_OF_MEAN|0.28||0.294|TWO_SIDED||||||Regression, Linear|||In this contrast, no contact control was compared against all other conditions (coded into one category and set as the reference group). The key outcome is the interaction between conditions and time (2019 as the reference group).||||.294
72338585|NCT03880838|144200895|SUPERIORITY||Slope|-0.28|STANDARD_ERROR_OF_MEAN|0.4||0.496|TWO_SIDED||||||Regression, Linear|||In this contrast, prevention conditions (coded into one category) were compared against no nudge conditions (coded into one category and set as the reference group).||||.496
72338586|NCT03880838|144200895|SUPERIORITY||Slope|-0.14|STANDARD_ERROR_OF_MEAN|0.4||0.722|TWO_SIDED||||||Regression, Linear|||In this contrast, commitment conditions (coded into one category) were compared against no nudge conditions (coded into one category and set as the reference group).||||.722
72338587|NCT03880838|144200895|SUPERIORITY||Slope|0.31|STANDARD_ERROR_OF_MEAN|0.4||0.445|TWO_SIDED||||||Regression, Linear|||In this contrast, both nudge conditions (coded into one category) were compared against no nudge conditions (coded into one category and set as the reference group).||||.445
72428200|NCT03954158|144367482|OTHER||Difference of least square mean|0.2|STANDARD_ERROR_OF_MEAN|0.55|||TWO_SIDED|95.0|-0.9|1.3||||||Change at Day 3, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen, day, dosing regimen-by-day interaction, and baseline value and the covariance structure UN was used.||1.3|-0.9|
72428201|NCT03954158|144367482|OTHER||Least squares mean of difference|-1.3|STANDARD_ERROR_OF_MEAN|0.38|||TWO_SIDED|95.0|-2.1|-0.5||||||Change at Day 4, Intra-participant: Mixed effect model for repeated measures included the fixed effect of day, and the covariance structure UN was used.||-0.5|-2.1|
72428202|NCT03954158|144367482|OTHER||Least squares mean of difference|-0.8|STANDARD_ERROR_OF_MEAN|0.34|||TWO_SIDED|95.0|-1.5|-0.1||||||Change at Day 4, Intra-participant: Mixed effect model for repeated measures included the fixed effect of day, and the covariance structure UN was used.||-0.1|-1.5|
72428203|NCT03954158|144367482|OTHER||Difference of least square mean|0.4|STANDARD_ERROR_OF_MEAN|0.5|||TWO_SIDED|95.0|-0.6|1.4||||||Change at Day 4, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen, day, dosing regimen-by-day interaction, and baseline value and the covariance structure UN was used.||1.4|-0.6|
72428204|NCT03954158|144367482|OTHER||Least squares mean of difference|-1.1|STANDARD_ERROR_OF_MEAN|0.4|||TWO_SIDED|95.0|-1.9|-0.3||||||Change at Day 5, Intra-participant: Mixed effect model for repeated measures included the fixed effect of day, and the covariance structure UN was used.||-0.3|-1.9|
72428205|NCT03954158|144367482|OTHER||Least squares mean of difference|-0.8|STANDARD_ERROR_OF_MEAN|0.34|||TWO_SIDED|95.0|-1.5|-0.1||||||Change at Day 5, Intra-participant: Mixed effect model for repeated measures included the fixed effect of day, and the covariance structure UN was used.||-0.1|-1.5|
72428206|NCT03954158|144367482|OTHER||Difference of least square mean|-0.1|STANDARD_ERROR_OF_MEAN|0.52|||TWO_SIDED|95.0|-1.1|1.0||||||Change at Day 5, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen, day, dosing regimen-by-day interaction, and baseline value and the covariance structure UN was used.||1.0|-1.1|
72428207|NCT03954158|144367482|OTHER||Least squares mean of difference|-1.3|STANDARD_ERROR_OF_MEAN|0.42|||TWO_SIDED|95.0|-2.1|-0.4||||||Change at Day 6, Intra-participant: Mixed effect model for repeated measures included the fixed effect of day, and the covariance structure UN was used.||-0.4|-2.1|
72428208|NCT03954158|144367482|OTHER||Least squares mean of difference|-0.3|STANDARD_ERROR_OF_MEAN|0.37|||TWO_SIDED|95.0|-1.1|0.4||||||Change at Day 6, Intra-participant: Mixed effect model for repeated measures included the fixed effect of day, and the covariance structure UN was used.||0.4|-1.1|
72338588|NCT03880838|144200895|SUPERIORITY||Slope|-0.24|STANDARD_ERROR_OF_MEAN|0.38||0.531|TWO_SIDED||||||Regression, Linear|||In this contrast, no nudge conditions (coded into one category) were compared against the letter condition (set as the reference group).||||.531
72428209|NCT03954158|144367482|OTHER||Difference of least square mean|0.5|STANDARD_ERROR_OF_MEAN|0.51|||TWO_SIDED|95.0|-0.6|1.5||||||Change at Day 6, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen, day, dosing regimen-by-day interaction, and baseline value and the covariance structure UN was used.||1.5|-0.6|
72428210|NCT03954158|144367482|OTHER||Least squares mean of difference|-1.2|STANDARD_ERROR_OF_MEAN|0.52|||TWO_SIDED|95.0|-2.3|-0.1||||||Change at Day 7, Intra-participant: Mixed effect model for repeated measures included the fixed effect of day, and the covariance structure UN was used.||-0.1|-2.3|
72428211|NCT03954158|144367482|OTHER||Least squares mean of difference|-0.4|STANDARD_ERROR_OF_MEAN|0.29|||TWO_SIDED|95.0|-1.0|0.2||||||Change at Day 7, Intra-participant: Mixed effect model for repeated measures included the fixed effect of day, and the covariance structure UN was used.||0.2|-1.0|
72428212|NCT03954158|144367482|OTHER||Difference of least square mean|0.3|STANDARD_ERROR_OF_MEAN|0.45|||TWO_SIDED|95.0|-0.6|1.3||||||Change at Day 7, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen, day, dosing regimen-by-day interaction, and baseline value and the covariance structure UN was used.||1.3|-0.6|
72338589|NCT03880838|144200895|SUPERIORITY||Slope|-0.51|STANDARD_ERROR_OF_MEAN|0.38||0.177|TWO_SIDED||||||Regression, Linear|||In this contrast, prevention conditions (coded into one category) were compared against the letter condition (set as the reference group).||||.177
72428213|NCT03954158|144367482|OTHER||Least squares mean of difference|-1.2|STANDARD_ERROR_OF_MEAN|0.4|||TWO_SIDED|95.0|-2.0|-0.3||||||Change at Day 8, Intra-participant: Mixed effect model for repeated measures included the fixed effect of day, and the covariance structure UN was used.||-0.3|-2.0|
72428214|NCT03954158|144367482|OTHER||Least squares mean of difference|-0.6|STANDARD_ERROR_OF_MEAN|0.35|||TWO_SIDED|95.0|-1.3|0.1||||||Change at Day 8, Intra-participant: Mixed effect model for repeated measures included the fixed effect of day, and the covariance structure UN was used.||0.1|-1.3|
72428215|NCT03954158|144367482|OTHER||Difference of least square mean|0.3|STANDARD_ERROR_OF_MEAN|0.44|||TWO_SIDED|95.0|-0.6|1.2||||||Change at Day 8, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen, day, dosing regimen-by-day interaction, and baseline value and the covariance structure UN was used.||1.2|-0.6|
72428216|NCT03954158|144367482|OTHER||Least squares mean of difference|-1.7|STANDARD_ERROR_OF_MEAN|0.36|||TWO_SIDED|95.0|-2.4|-0.9||||||Change at Day 9, Intra-participant: Mixed effect model for repeated measures included the fixed effect of day, and the covariance structure UN was used.||-0.9|-2.4|
72428217|NCT03954158|144367482|OTHER||Least squares mean of difference|-0.4|STANDARD_ERROR_OF_MEAN|0.52|||TWO_SIDED|95.0|-1.5|0.7||||||Change at Day 9, Intra-participant: Mixed effect model for repeated measures included the fixed effect of day, and the covariance structure UN was used.||0.7|-1.5|
72428218|NCT03954158|144367482|OTHER||Difference of least square mean|0.5|STANDARD_ERROR_OF_MEAN|0.59|||TWO_SIDED|95.0|-0.7|1.6||||||Change at Day 9, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen, day, dosing regimen-by-day interaction, and baseline value and the covariance structure UN was used.||1.6|-0.7|
72338590|NCT03880838|144200895|SUPERIORITY||Slope|-0.38|STANDARD_ERROR_OF_MEAN|0.38||0.314|TWO_SIDED||||||Regression, Linear|||In this contrast, commitment conditions (coded into one category) were compared against the letter condition (set as the reference group).||||.314
72338591|NCT03880838|144200895|SUPERIORITY||Slope|0.07|STANDARD_ERROR_OF_MEAN|0.38||0.85|TWO_SIDED||||||Regression, Linear|||In this contrast, both nudge conditions (coded into one category) were compared against the letter condition (set as the reference group).||||.850
72338592|NCT03880838|144200895|SUPERIORITY||Slope|0.32|STANDARD_ERROR_OF_MEAN|0.37||0.391|TWO_SIDED||||||Regression, Linear|||In this contrast, no nudge conditions (coded into one category) were compared against the no contact condition (set as the reference group).||||.391
72338593|NCT03880838|144200895|SUPERIORITY||Slope|0.04|STANDARD_ERROR_OF_MEAN|0.37||0.906|TWO_SIDED||||||Regression, Linear|||In this contrast, prevention conditions (coded into one category) were compared against the no contact condition (set as the reference group).||||.906
72338594|NCT03880838|144200895|SUPERIORITY||Slope|0.18|STANDARD_ERROR_OF_MEAN|0.37||0.635|TWO_SIDED||||||Regression, Linear|||In this contrast, commitment conditions (coded into one category) were compared against the no contact condition (set as the reference group).||||.635
72338595|NCT03880838|144200895|SUPERIORITY||Slope|0.63|STANDARD_ERROR_OF_MEAN|0.37||0.093|TWO_SIDED||||||Regression, Linear|||In this contrast, both nudge conditions (coded into one category) were compared against the no contact condition (set as the reference group).||||0.093
72338596|NCT02209948|144200919|OTHER|Log Rank (Mantel-Cox)||||||0.943||||||Threshold P-value of 0.05|Log Rank|||||||0.943
72338597|NCT02209948|144200920|OTHER||Hazard Ratio (HR)|1.3||||0.16|TWO_SIDED|95.0|0.9|1.88||Threshold of significance P-value 0.05|Regression, Cox|||||1.88|0.90|0.16
72338598|NCT02209948|144200921|OTHER||Hazard Ratio (HR)|1.0||||0.99|TWO_SIDED|95.0|0.65|1.5||Threshold for significance P-value 0.05|Regression, Cox|||||1.5|0.65|0.99
72338599|NCT02209948|144200922|OTHER||Hazard Ratio (HR)|1.45||||0.13|TWO_SIDED|95.0|0.89|2.33||threshold for significance 0.05|Regression, Cox|||||2.33|0.89|0.13
72338600|NCT01891344|144200971|SUPERIORITY||Cox Proportional Hazard|0.273|||||TWO_SIDED|95.0|0.17|0.437||||||||0.437|0.170|
72338601|NCT01891344|144200971|SUPERIORITY||Cox Proportional Hazard|0.61|||||TWO_SIDED|95.0|0.428|0.871||||||||0.871|0.428|
72338602|NCT03523273|144201009|SUPERIORITY|||||||0.004|||||||Wilcoxon (Mann-Whitney)|||||||0.004
72338603|NCT03523273|144201010|SUPERIORITY|||||||0.033|||||||Wilcoxon (Mann-Whitney)|||||||0.033
72338604|NCT02590562|144201066|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||F test|||||||<0.0001
72338605|NCT02590562|144201067|SUPERIORITY_OR_OTHER|||||||0.0108|TWO_SIDED||||||F test|||||||0.0108
72338606|NCT02042534|144201088|SUPERIORITY_OR_OTHER|||||||0.6765|||||||Chi-squared|||||||0.6765
72338607|NCT02042534|144201089|SUPERIORITY_OR_OTHER|||||||0.3753|||||||Chi-squared|||||||0.3753
72338608|NCT02042534|144201090|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test||||||<.0001
72338609|NCT02042534|144201091|SUPERIORITY_OR_OTHER|||||||0.3301|||||||Cochran-Mantel-Haenszel|||||||0.3301
72338610|NCT00598078|144201094|SUPERIORITY_OR_OTHER|||||||0.013||95.0|||||ANOVA|||||||0.013
72338611|NCT00598078|144201094|SUPERIORITY_OR_OTHER|||||||0.713||95.0|||||ANOVA|||||||0.713
72338612|NCT00598078|144201094|SUPERIORITY_OR_OTHER|||||||0.038||95.0|||||ANOVA|||||||0.038
72338613|NCT02120365|144201111|SUPERIORITY||Mean Difference (Final Values)|0.729|STANDARD_ERROR_OF_MEAN|1.986||0.867|TWO_SIDED||||||Mixed Models Analysis||Representing the high dose 10mg compared to the placebo 0mg dose.|Medication dose was a within-subjects factor (crossover design)||||0.867
72338614|NCT02120365|144201112|SUPERIORITY||Mean Difference (Final Values)|5.514|STANDARD_ERROR_OF_MEAN|3.038||0.071|TWO_SIDED||||||Mixed Models Analysis||Representing the high dose 10mg compared to the placebo 0mg dose.|mixed models, medication was a within-subjects factor||||0.071
72338615|NCT02120365|144201113|SUPERIORITY||Mean Difference (Final Values)|0.729|STANDARD_ERROR_OF_MEAN|2.905||0.667|TWO_SIDED||||||Mixed Models Analysis||Representing the high dose 10mg compared to the placebo 0mg dose.|mixed models||||0.667
72338616|NCT02120365|144201114|SUPERIORITY||Mean Difference (Final Values)|2.242|STANDARD_ERROR_OF_MEAN|1.393||0.285|TWO_SIDED||||||Mixed Models Analysis||Representing the high dose 10mg compared to the placebo 0mg dose.|||||0.285
72338617|NCT02120365|144201115|SUPERIORITY||Mean Difference (Final Values)|0.235|STANDARD_ERROR_OF_MEAN|0.408||0.843|TWO_SIDED||||||Mixed Models Analysis||Representing the high dose 10mg compared to the placebo 0mg dose.|Mixed Models||||.843
72338618|NCT02120365|144201116|SUPERIORITY||Mean Difference (Final Values)|0.369|STANDARD_ERROR_OF_MEAN|2.07||0.691|TWO_SIDED||||||Mixed Models Analysis||Representing the high dose 10mg compared to the placebo 0mg dose.|We report the main effect of dose on the outcome measure||||.691
72338619|NCT01726673|144201117|EQUIVALENCE|Statistical analysis of median change from baseline to DC immediately following 12 weeks of training was assessed with the upper extremity fugl meyer score in the active vs. sham tDCS conditions. Null hypothesis is that there is no difference in median change in upper extremity fugl meyer score between the active and sham tDCS conditions. A significance level of 0.05 was used (two-tailed).|U value|302.0||||0.256|TWO_SIDED|||||The Mann-Whitney U test was performed to compare median change in upper extremity fugl meyer score from baseline to 12 weeks (discharge) across two separate study conditions (active vs. sham tDCS).|Mann-Whitney U test|||||||0.256
72338620|NCT01726673|144201117|EQUIVALENCE|Statistical analysis of median change from baseline to week 36 (6 month follow-up) was assessed with upper extremity fugl meyer score for the active vs. sham tDCS conditions. Null hypothesis is that there is no difference in median change in upper extremity fugl meyer score between the active and sham tDCS conditions. A significance level of 0.05 was used (two-tailed).|U value|222.0||||0.222|TWO_SIDED|||||The Mann-Whitney U test was performed to compare median change in upper extremity fugl meyer score from baseline to 36 weeks (follow-up) across two separate study conditions (active vs. sham tDCS).|Mann-Whitney U test|||||||0.222
72338621|NCT01726673|144201118|EQUIVALENCE|Statistical analysis of median change from baseline to DC immediately following 12 weeks of training was assessed with the WOLF Motor Function test time score (out of 1800 seconds) in the active vs. sham tDCS conditions. Null hypothesis is that there is no difference in median change in WMFT time score between the active and sham tDCS conditions. A significance level of 0.05 was used (two-tailed).|U Value|251.5||||1|TWO_SIDED|||||The Mann-Whitney U test was performed to compare median change in the WMFT time score from baseline to 12 weeks (discharge) across two separate study conditions (active vs. sham tDCS).|Mann-Whitney U Test|||||||1.0
72338622|NCT01726673|144201118|EQUIVALENCE|Statistical analysis of median change from baseline to week 36 (6 month follow-up) was assessed with the WOLF Motor Function test time score (out of 1800 seconds) in the active vs. sham tDCS conditions. Null hypothesis is that there is no difference in median change in WMFT time score between the active and sham tDCS conditions. A significance level of 0.05 was used (two-tailed).|U value|208.5||||0.592|TWO_SIDED|||||The Mann-Whitney U test was performed to compare median change in the WMFT time score from baseline to 36 weeks ( 6 month follow-up) across two separate study conditions (active vs. sham tDCS).|Mann-Whitney U Test|||||||0.592
72338623|NCT01726673|144201119|EQUIVALENCE|Statistical analysis of median change from baseline to DC immediately following 12 weeks of training was assessed with the Motor Power Manual Muscle Test Score for the upper extremity (out of 100 points) in the active vs. sham tDCS conditions. Null hypothesis is that there is no difference in median change in MRC score between the active and sham tDCS conditions. A significance level of 0.05 was used (two-tailed).|U value|270.5||||0.68|TWO_SIDED|||||The Mann-Whitney U test was performed to compare median change in the MRC score from baseline to 12 weeks (discharge) across two separate study conditions (active vs. sham tDCS).|Mann-Whitney U test|||||||0.680
72338624|NCT01726673|144201119|EQUIVALENCE|Statistical analysis of median change from baseline to week 36 (6 month FU) was assessed with the Motor Power Manual Muscle Test Score for the upper extremity (out of 100 points) in the active vs. sham tDCS conditions. Null hypothesis is that there is no difference in median change in MRC score between the active and sham tDCS conditions. A significance level of 0.05 was used (two-tailed).|U value|187.5||||0.837|TWO_SIDED|||||The Mann-Whitney U test was performed to compare median change in the MRC score from baseline to 6 month FU across two separate study conditions (active vs. sham tDCS).|Mann-Whitney U Test|||||||0.837
72338625|NCT01719003|144201120|SUPERIORITY_OR_OTHER||Adjusted mean|-0.33|STANDARD_ERROR_OF_MEAN|0.12||0.0056|TWO_SIDED|95.0|-0.56|-0.1|||Mixed Models Analysis|'Baseline HbA1c':linear covariate;'treatment','baseline renal function','region','visit' \& 'visit by treatment interaction':fixed effects.|Empagliflozin 12.5 mg bid+ Metformin 1000 mg bid minus Metformin 1000 mg bid|Restricted maximum likelihood (REML)-based mixed model repeated measures (MMRM) approach comparing the change from baseline of HbA1c (in units of %) after 24 weeks of double-blind treatment.||-0.10|-0.56|0.0056
72338626|NCT01719003|144201120|SUPERIORITY_OR_OTHER||Adjusted mean|-0.72|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-0.95|-0.48|||Mixed Models Analysis|'Baseline HbA1c':linear covariate;'treatment','baseline renal function','region','visit' \& 'visit by treatment interaction':fixed effects.|Empagliflozin 12.5 mg bid+ Metformin 1000 mg bid minus Empagliflozin 25 mg qd|Restricted maximum likelihood (REML)-based mixed model repeated measures (MMRM) approach comparing the change from baseline of HbA1c (in units of %) after 24 weeks of double-blind treatment.||-0.48|-0.95|<0.0001
72338627|NCT01719003|144201120|SUPERIORITY_OR_OTHER||Adjusted Mean|-0.75|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-0.98|-0.51|||Mixed Models Analysis|'Baseline HbA1c':linear covariate;'treatment','baseline renal function','region','visit' \& 'visit by treatment interaction':fixed effects.|Empagliflozin 12.5 mg bid+ Metformin 500 mg bid minus Metformin 500 mg bid|Restricted maximum likelihood (REML)-based mixed model repeated measures (MMRM) approach comparing the change from baseline of HbA1c (in units of %) after 24 weeks of double-blind treatment.||-0.51|-0.98|<0.0001
72338628|NCT01719003|144201120|SUPERIORITY_OR_OTHER||Adjusted mean|-0.57|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-0.81|-0.34|||Mixed Models Analysis|'Baseline HbA1c':linear covariate;'treatment','baseline renal function','region','visit' \& 'visit by treatment interaction':fixed effects.|Empagliflozin 12.5 mg bid+ Metformin 500 mg bid minus Empagliflozin 25 mg qd|Restricted maximum likelihood (REML)-based mixed model repeated measures (MMRM) approach comparing the change from baseline of HbA1c (in units of %) after 24 weeks of double-blind treatment.||-0.34|-0.81|<0.0001
72338629|NCT01719003|144201120|SUPERIORITY_OR_OTHER||Adjusted mean|-0.33|STANDARD_ERROR_OF_MEAN|0.12||0.0062|TWO_SIDED|95.0|-0.56|-0.09|||Mixed Models Analysis|'Baseline HbA1c':linear covariate;'treatment','baseline renal function','region','visit' \& 'visit by treatment interaction':fixed effects.|Empagliflozin 5 mg bid + Metformin 1000 mg bid minus Metformin 1000 mg bid|Restricted maximum likelihood (REML)-based mixed model repeated measures (MMRM) approach comparing the change from baseline of HbA1c (in units of %) after 24 weeks of double-blind treatment||-0.09|-0.56|0.0062
72338630|NCT01719003|144201120|SUPERIORITY_OR_OTHER||Adjusted Mean|-0.72|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-0.95|-0.49|||Mixed Models Analysis|'Baseline HbA1c':linear covariate;'treatment','baseline renal function','region','visit' \& 'visit by treatment interaction':fixed effects.|Empagliflozin 5 mg bid + Metformin 1000 mg bid minus Empagliflozin 10 mg qd|Restricted maximum likelihood (REML)-based mixed model repeated measures (MMRM) approach comparing the change from baseline of HbA1c (in units of %) after 24 weeks of double-blind treatment.||-0.49|-0.95|<0.0001
72338631|NCT01719003|144201120|SUPERIORITY_OR_OTHER||Adjusted Mean|-0.79|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-1.03|-0.56|||Mixed Models Analysis|'Baseline HbA1c':linear covariate;'treatment','baseline renal function','region','visit' \& 'visit by treatment interaction':fixed effects.|Empagliflozin 5 mg bid + Metformin 500 mg bid minus Metformin 500 mg bid|Restricted maximum likelihood (REML)-based mixed model repeated measures (MMRM) approach comparing the change from baseline of HbA1c (in units of %) after 24 weeks of double-blind treatment.||-0.56|-1.03|<0.0001
72338632|NCT01719003|144201120|SUPERIORITY_OR_OTHER||Adjusted mean|-0.63|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-0.86|-0.4|||Mixed Models Analysis|'Baseline HbA1c':linear covariate;'treatment','baseline renal function','region','visit' \& 'visit by treatment interaction':fixed effects.|Empagliflozin 5 mg bid + Metformin 500 mg bid minus Empagliflozin 10 mg qd|Restricted maximum likelihood (REML)-based mixed model repeated measures (MMRM) approach comparing the change from baseline of HbA1c (in units of %) after 24 weeks of double-blind treatment.||-0.40|-0.86|<0.0001
72338633|NCT01719003|144201120|NON_INFERIORITY_OR_EQUIVALENCE|The noninferiority of empagliflozin 10 mg qd against metformin 1000 mg bid were to be tested for HbA1c change from baseline to Week 24 at the level of α=0.025 (one-sided), through application of a non-inferiority margin of 0.35%.|Adjusted mean|0.39|STANDARD_ERROR_OF_MEAN|0.12||0.6246|TWO_SIDED|95.0|0.15|0.62|||Mixed Models Analysis|'Baseline HbA1c':linear covariate;'treatment','baseline renal function','region','visit' \& 'visit by treatment interaction':fixed effects.|Empagliflozin 25 mg qd minus Metformin 1000 mg bid|Restricted maximum likelihood (REML)-based mixed model repeated measures (MMRM) approach comparing the change from baseline of HbA1c (in units of %) after 24 weeks of double-blind treatment.||0.62|0.15|0.6246
72338634|NCT01719003|144201120|NON_INFERIORITY_OR_EQUIVALENCE|The noninferiority of empagliflozin 10 mg qd against metformin 1000 mg bid were to be tested for HbA1c change from baseline to Week 24 at the level of α=0.025 (one-sided), through application of a non-inferiority margin of 0.35%.|Adjusted mean|0.4|STANDARD_ERROR_OF_MEAN|0.12||0.6558|TWO_SIDED|95.0|0.16|0.63|||Mixed Models Analysis|'Baseline HbA1c':linear covariate;'treatment','baseline renal function','region','visit' \& 'visit by treatment interaction':fixed effects.|Empagliflozin 10 mg qd minus Metformin 1000 mg bid|Restricted maximum likelihood (REML)-based mixed model repeated measures (MMRM) approach comparing the change from baseline of HbA1c (in units of %) after 24 weeks of double-blind treatment.||0.63|0.16|0.6558
72338635|NCT01719003|144201121|SUPERIORITY_OR_OTHER||Adjusted mean|-18.8|STANDARD_ERROR_OF_MEAN|3.4|<|0.0001|TWO_SIDED|95.0|-25.5|-12.2||Since previous step in the hierarchical testing failed (primary measure analyses 9 and 10), the analyses for secondary measures of FPG and body weight are considered exploratory and not confirmatory|Mixed Models Analysis|'Baseline HbA1c':linear covariate;'treatment','baseline renal function','region','visit' \& 'visit by treatment interaction':fixed effects.|Empagliflozin 12.5 mg bid+ Metformin 1000 mg bid minus Metformin 1000 mg bid|Restricted maximum likelihood (REML)-based mixed model repeated measures (MMRM) approach comparing the change from baseline of FPG after 24 weeks of double-blind treatment.||-12.2|-25.5|<0.0001
72338636|NCT01719003|144201121|SUPERIORITY_OR_OTHER||Adjusted mean|-23.0|STANDARD_ERROR_OF_MEAN|3.4|<|0.0001|TWO_SIDED|95.0|-29.7|-16.3||Since previous step in the hierarchical testing failed (primary measure analyses 9 and 10), the analyses for secondary measures of FPG and body weight are considered exploratory and not confirmatory|Mixed Models Analysis|'Baseline HbA1c':linear covariate;'treatment','baseline renal function','region','visit' \& 'visit by treatment interaction':fixed effects.|Empagliflozin 12.5 mg bid+ Metformin 1000 mg bid minus Empagliflozin 25 mg qd|Restricted maximum likelihood (REML)-based mixed model repeated measures (MMRM) approach comparing the change from baseline of FPG after 24 weeks of double-blind treatment.||-16.3|-29.7|<0.0001
72338637|NCT01719003|144201121|SUPERIORITY_OR_OTHER||Adjusted Mean|-26.7|STANDARD_ERROR_OF_MEAN|3.4|<|0.0001|TWO_SIDED|95.0|-33.5|-20.0||Since previous step in the hierarchical testing failed (primary measure analyses 9 and 10), the analyses for secondary measures of FPG and body weight are considered exploratory and not confirmatory|Mixed Models Analysis|'Baseline HbA1c':linear covariate;'treatment','baseline renal function','region','visit' \& 'visit by treatment interaction':fixed effects.|Empagliflozin 12.5 mg bid+ Metformin 500 mg bid minus Metformin 500 mg bid|Restricted maximum likelihood (REML)-based mixed model repeated measures (MMRM) approach comparing the change from baseline of FPG after 24 weeks of double-blind treatment.||-20.0|-33.5|<0.0001
72338638|NCT01719003|144201121|SUPERIORITY_OR_OTHER||Adjusted mean|-16.0|STANDARD_ERROR_OF_MEAN|3.4|<|0.0001|TWO_SIDED|95.0|-22.8|-9.2||Since previous step in the hierarchical testing failed (primary measure analyses 9 and 10), the analyses for secondary measures of FPG and body weight are considered exploratory and not confirmatory|Mixed Models Analysis|'Baseline HbA1c':linear covariate;'treatment','baseline renal function','region','visit' \& 'visit by treatment interaction':fixed effects.|Empagliflozin 12.5 mg bid+ Metformin 500 mg bid minus Empagliflozin 25 mg qd|Restricted maximum likelihood (REML)-based mixed model repeated measures (MMRM) approach comparing the change from baseline of FPG after 24 weeks of double-blind treatment.||-9.2|-22.8|<0.0001
72338639|NCT01719003|144201121|SUPERIORITY_OR_OTHER||Adjusted mean|-15.6|STANDARD_ERROR_OF_MEAN|3.4|<|0.0001|TWO_SIDED|95.0|-22.3|-8.9||Since previous step in the hierarchical testing failed (primary measure analyses 9 and 10), the analyses for secondary measures of FPG and body weight are considered exploratory and not confirmatory|Mixed Models Analysis|'Baseline HbA1c':linear covariate;'treatment','baseline renal function','region','visit' \& 'visit by treatment interaction':fixed effects.|Empagliflozin 5 mg bid + Metformin 1000 mg bid minus Metformin 1000 mg bid|Restricted maximum likelihood (REML)-based mixed model repeated measures (MMRM) approach comparing the change from baseline of FPG of double-blind treatment||-8.9|-22.3|<0.0001
72338640|NCT01719003|144201121|SUPERIORITY_OR_OTHER||Adjusted Mean|-14.8|STANDARD_ERROR_OF_MEAN|3.4|<|0.0001|TWO_SIDED|95.0|-21.4|-8.2||Since previous step in the hierarchical testing failed (primary measure analyses 9 and 10), the analyses for secondary measures of FPG and body weight are considered exploratory and not confirmatory|Mixed Models Analysis|'Baseline HbA1c':linear covariate;'treatment','baseline renal function','region','visit' \& 'visit by treatment interaction':fixed effects.|Empagliflozin 5 mg bid + Metformin 1000 mg bid minus Empagliflozin 10 mg qd|Restricted maximum likelihood (REML)-based mixed model repeated measures (MMRM) approach comparing the change from baseline of FPG after 24 weeks of double-blind treatment.||-8.2|-21.4|<0.0001
72338641|NCT01719003|144201121|SUPERIORITY_OR_OTHER||Adjusted Mean|-28.2|STANDARD_ERROR_OF_MEAN|3.4|<|0.0001|TWO_SIDED|95.0|-35.0|-21.5||Since previous step in the hierarchical testing failed (primary measure analyses 9 and 10), the analyses for secondary measures of FPG and body weight are considered exploratory and not confirmatory|Mixed Models Analysis|'Baseline HbA1c':linear covariate;'treatment','baseline renal function','region','visit' \& 'visit by treatment interaction':fixed effects.|Empagliflozin 5 mg bid + Metformin 500 mg bid minus Metformin 500 mg bid|Restricted maximum likelihood (REML)-based mixed model repeated measures (MMRM) approach comparing the change from baseline of FPG after 24 weeks of double-blind treatment.||-21.5|-35.0|<0.0001
72338642|NCT01719003|144201121|SUPERIORITY_OR_OTHER||Adjusted mean|-12.6|STANDARD_ERROR_OF_MEAN|3.4||0.0002|TWO_SIDED|95.0|-19.1|-6.0||Since previous step in the hierarchical testing failed (primary measure analyses 9 and 10), the analyses for secondary measures of FPG and body weight are considered exploratory and not confirmatory|Mixed Models Analysis|'Baseline HbA1c':linear covariate;'treatment','baseline renal function','region','visit' \& 'visit by treatment interaction':fixed effects.|Empagliflozin 5 mg bid + Metformin 500 mg bid minus Empagliflozin 10 mg qd|Restricted maximum likelihood (REML)-based mixed model repeated measures (MMRM) approach comparing the change from baseline of FPG after 24 weeks of double-blind treatment.||-6.0|-19.1|0.0002
72338643|NCT01719003|144201122|SUPERIORITY_OR_OTHER||Adjusted mean|-2.5|STANDARD_ERROR_OF_MEAN|0.42|<|0.0001|TWO_SIDED|95.0|-3.33|-1.68||Since previous step in the hierarchical testing failed (primary measure analyses 9 and 10), the analyses for secondary measures of FPG and body weight are considered exploratory and not confirmatory|Mixed Models Analysis|'Baseline HbA1c':linear covariate;'treatment','baseline renal function','region','visit' \& 'visit by treatment interaction':fixed effects.|Empagliflozin 12.5 mg bid+ Metformin 1000 mg bid minus Metformin 1000 mg bid|Restricted maximum likelihood (REML)-based mixed model repeated measures (MMRM) approach comparing the change from baseline of body weight after 24 weeks of double-blind treatment.||-1.68|-3.33|<0.0001
72428219|NCT03954158|144367482|OTHER||Least squares mean of difference|-1.6|STANDARD_ERROR_OF_MEAN|0.31|||TWO_SIDED|95.0|-2.3|-0.9||||||Change at Day 10, Intra-participant: Mixed effect model for repeated measures included the fixed effect of day, and the covariance structure UN was used.||-0.9|-2.3|
72428220|NCT03954158|144367482|OTHER||Least squares mean of difference|-1.1|STANDARD_ERROR_OF_MEAN|0.47|||TWO_SIDED|95.0|-2.1|-0.1||||||Change at Day 10, Intra-participant: Mixed effect model for repeated measures included the fixed effect of day, and the covariance structure UN was used.||-0.1|-2.1|
72338644|NCT01719003|144201122|SUPERIORITY_OR_OTHER||Adjusted Mean|-2.52|STANDARD_ERROR_OF_MEAN|0.42|<|0.0001|TWO_SIDED|95.0|-3.35|-1.69||Since previous step in the hierarchical testing failed (primary measure analyses 9 and 10), the analyses for secondary measures of FPG and body weight are considered exploratory and not confirmatory|Mixed Models Analysis|'Baseline HbA1c':linear covariate;'treatment','baseline renal function','region','visit' \& 'visit by treatment interaction':fixed effects.|Empagliflozin 12.5 mg bid+ Metformin 500 mg bid minus Metformin 500 mg bid|Restricted maximum likelihood (REML)-based mixed model repeated measures (MMRM) approach comparing the change from baseline of body weight after 24 weeks of double-blind treatment.||-1.69|-3.35|<0.0001
72338645|NCT01719003|144201122|SUPERIORITY_OR_OTHER||Adjusted mean|-2.2|STANDARD_ERROR_OF_MEAN|0.42|<|0.0001|TWO_SIDED|95.0|-3.03|-1.37||Since previous step in the hierarchical testing failed (primary measure analyses 9 and 10), the analyses for secondary measures of FPG and body weight are considered exploratory and not confirmatory|Mixed Models Analysis|'Baseline HbA1c':linear covariate;'treatment','baseline renal function','region','visit' \& 'visit by treatment interaction':fixed effects.|Empagliflozin 5 mg bid + Metformin 1000 mg bid minus Metformin 1000 mg bid|Restricted maximum likelihood (REML)-based mixed model repeated measures (MMRM) approach comparing the change from baseline of body weight after 24 weeks of double-blind treatment||-1.37|-3.03|<0.0001
72338646|NCT01719003|144201122|SUPERIORITY_OR_OTHER||Adjusted Mean|-2.26|STANDARD_ERROR_OF_MEAN|0.42|<|0.0001|TWO_SIDED|95.0|-3.09|-1.43||Since previous step in the hierarchical testing failed (primary measure analyses 9 and 10), the analyses for secondary measures of FPG and body weight are considered exploratory and not confirmatory|Mixed Models Analysis|'Baseline HbA1c':linear covariate;'treatment','baseline renal function','region','visit' \& 'visit by treatment interaction':fixed effects.|Empagliflozin 5 mg bid + Metformin 500 mg bid minus Metformin 500 mg bid|Restricted maximum likelihood (REML)-based mixed model repeated measures (MMRM) approach comparing the change from baseline of body weight after 24 weeks of double-blind treatment.||-1.43|-3.09|<0.0001
72338647|NCT00700102|144201146|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.81||||0.0062|TWO_SIDED|95.0|0.69|0.94|||Log Rank|||||0.94|0.69|0.0062
72338648|NCT00700102|144201147|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.9||||0.1713|TWO_SIDED|95.0|0.77|1.05|||Log Rank|||Kaplan Meier Estimate||1.05|0.77|0.1713
72338649|NCT00700102|144201149|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.68|||<|0.0001|TWO_SIDED|95.0|0.59|0.78|||Log Rank|||||0.78|0.59|<.0001
72338650|NCT00700102|144201150|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.5||||0.3113|TWO_SIDED|95.0|-1.5|4.5|||Chi-squared|||||4.5|-1.5|0.3113
72338651|NCT00700102|144201150|SUPERIORITY_OR_OTHER|||||||0.4315|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.4315
72338652|NCT01811303|144201152|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||ANOVA|||||||<0.0001
72338653|NCT01811303|144201152|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.016||95.0|||||ANOVA|||||||<0.016
72338654|NCT02525939|144201154|SUPERIORITY||Hazard Ratio (HR)|0.88||||0.12|TWO_SIDED|95.0|0.75|1.03||The estimated HR was presented with a 95% CI and a p-value. The primary analysis was conducted at the 0.05 significance level.|Stratified Cox proportional hazard model|||A stratified Cox proportional hazards model was used to analyze the primary endpoint. This model included treatment as a main effect, and region and acute coronary syndrome (ACS) index event type as stratification factors. The null and alternative hypotheses tested with the above Cox model were: H0: λ = 1 vs HA: λ ≠ 1, where λ is the, assumed constant, hazard ratio (HR) for the time to occurrence of the composite events of the primary endpoint for the dalcetrapib and placebo treated groups.||1.03|0.75|0.12
72338655|NCT02525939|144201155|SUPERIORITY||Hazard Ratio (HR)|1.0||||0.95|TWO_SIDED|95.0|0.88|1.13|||Stratified Cox proportional hazard model|||Secondary endpoints were expressed as time to event and an analysis similar to that for the primary endpoint was conducted. In order to control the family-wise Type I error that results from the multiplicity of endpoints, the secondary endpoints were formally tested using the Hochberg's step-up procedure only if the primary analysis results in significant treatment effect at p\<0.05. Otherwise, statistical tests for the secondary endpoints were presented solely for illustrative purposes.||1.13|0.88|0.95
72338656|NCT02525939|144201156|SUPERIORITY||Hazard Ratio (HR)|0.92||||0.27|TWO_SIDED|95.0|0.79|1.07|||Stratified Cox proportional hazard model|||Secondary endpoints were expressed as time to event and an analysis similar to that for the primary endpoint was conducted. In order to control the family-wise Type I error that results from the multiplicity of endpoints, the secondary endpoints were formally tested using the Hochberg's step-up procedure only if the primary analysis results in significant treatment effect at p\<0.05. Otherwise, statistical tests for the secondary endpoints were presented solely for illustrative purposes.||1.07|0.79|0.27
72338657|NCT00762996|144201170|NON_INFERIORITY_OR_EQUIVALENCE|"margin +/- 0.5 logMar lines~The range of non-inferiority for this value is 0.50 thus +/- 0.50 is considered non-inferior to the 0.0 mark.~logarithm of the minimum angle of resolution (logMar) ideal is 0.0 and represents 20/20 Snellen acuity. logMar values \> 0.00 indicate vision poorer than the ideal and values \<0.00 indicate vision greater than the ideal."|Mean Difference (Final Values)|0.005287|STANDARD_ERROR_OF_MEAN|0.00976||||95.0|-0.01389|0.2447|||Mixed Models Analysis||logarithm of the minimum angle of resolution (logMar) ideal is 0.0 and represents 20/20 Snellen acuity. logMar values \> 0.00 indicate vision poorer than the ideal and values \<0.00 indicate vision greater than the ideal.|Null Hypothesis: etafilcon A is greater than or equal to omafilcon A.||0.2447|-0.01389|
72338658|NCT00762996|144201171|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.4757|STANDARD_ERROR_OF_MEAN|0.2505||||95.0|0.05563|0.4757|||Mixed Models Analysis||Mean difference is etafilcon A minus omafilcon A.|||0.4757|0.05563|
72338659|NCT02084238|144201195|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.01|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Comparing the data between baseline and week 10.||||<0.01
72338660|NCT00320372|144201200|SUPERIORITY_OR_OTHER||MMRM Least Squares Mean|38.1|||||TWO_SIDED|95.0|36.3|39.9|||||Mixed Model Repeated Measure analysis on MADRS responders (binary variable with 1=yes, 0=no) as the response variable in the model. The covariates are treatment, visit and propensity quintile. This analysis of covariance produced least square means.|Null Hypothesis: Percentage of responders across groups is the same. Alternate Hypothesis: Percentage of responders across groups is different.||39.9|36.3|
72428221|NCT03954158|144367482|OTHER||Difference of Least Squares Mean|0.2|STANDARD_ERROR_OF_MEAN|0.49|||TWO_SIDED|95.0|-0.8|1.2||||||Change at Day 10, Inter-participant: Mixed effect Model for Repeated Measures included the fixed effects of dosing regimen, day, dosing regimen-by-day interaction, and baseline value, and the covariance structure UN was used.||1.2|-0.8|
72338661|NCT00320372|144201200|SUPERIORITY_OR_OTHER||MMRM Least Squares Mean|17.0|||||TWO_SIDED|95.0|15.2|19.0|||||Mixed Model Repeated Measure analysis on MADRS responders (binary variable with 1=yes, 0=no) as the response variable in the model. The covariates are treatment, visit and propensity quintile. This analysis of covariance produced least square means.|Null Hypothesis: Percentage of responders across groups is the same. Alternate Hypothesis: Percentage of responders across groups is different.||19.0|15.2|
72338662|NCT00320372|144201200|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|||Null Hypothesis: Percentage of responders across groups is the same. Alternate Hypothesis: Percentage of responders across groups is different.||||<.0001
72338663|NCT00320372|144201201|SUPERIORITY_OR_OTHER|||||||0.1015|TWO_SIDED|||||Comparison for Kaplan Meier Median Time until recurrence|Log Rank|Null hypothesis: median TUR between 2 groups is not different. Alternate hypothesis: median TUR between 2 groups is different.||||||0.1015
72338664|NCT00320372|144201202|SUPERIORITY_OR_OTHER||MMRM Least Squares Mean|19.8|||||TWO_SIDED|95.0|18.4|21.3|||||Mixed Model Repeated Measure analysis on MADRS remitters (binary variable with 1=yes, 0=no) as the response variable in the model. The covariates are treatment, visit and propensity quintile. This analysis of covariance produced least square means.|Null Hypothesis: Percentage of remitters across groups is the same. Alternate Hypothesis: Percentage of remitters across groups is different.||21.3|18.4|
72338665|NCT00320372|144201202|SUPERIORITY_OR_OTHER||MMRM Least Squares Mean|8.1|||||TWO_SIDED|95.0|6.9|9.5|||||Mixed Model Repeated Measure analysis on MADRS remitters (binary variable with 1=yes, 0=no) as the response variable in the model. The covariates are treatment, visit and propensity quintile. This analysis of covariance produced least square means.|Null Hypothesis: Percentage of remitters across groups is the same. Alternate Hypothesis: Percentage of remitters across groups is different.||9.5|6.9|
72338666|NCT00320372|144201202|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|||Null Hypothesis: Percentage of responders across groups is the same. Alternate Hypothesis: Percentage of responders across groups is different.||||<.0001
72338667|NCT00320372|144201208|SUPERIORITY_OR_OTHER||Pearson Correlation Coefficients|0.34997|||<|0.0001|TWO_SIDED|||||"Null hypothesis: There is a correlation between MADRS follow-up suicidal thoughts and baseline suicidal thoughts.~Alternate hypothesis: There is no correlation between MADRS follow-up suicidal thoughts and baseline suicidal thoughts."|Pearson Correlation Coefficients|||The statistical modeling of predictors of suicide attempts and suicidal ideations considered 15 variables, defined in the protocol a priori to determine which ones were predictive of suicide attempts and suicidal ideations. Four variables representing the baseline disease and patient factors were considered predictors of suicidality. This outcome measure presents the underlying data collected and the corresponding correlation coefficient for one of the 4 variables identified.||||<0.0001
72338668|NCT00320372|144201209|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||"Null Hypothesis: Difference between change from baseline value of two treatment groups equals zero.~Alternate Hypothesis: Difference between change from baseline value of two treatment groups is not equal to zero."|F-Test|||3 Month Time point||||<.0001
72338669|NCT00320372|144201209|SUPERIORITY_OR_OTHER|||||||0.0068|TWO_SIDED|||||"Null Hypothesis: Difference between change from baseline value of two treatment groups equals zero.~Alternate Hypothesis: Difference between change from baseline value of two treatment groups is not equal to zero."|F-Test|||6 Month Time point||||.0068
72338670|NCT00320372|144201209|SUPERIORITY_OR_OTHER|||||||0.0008|TWO_SIDED|||||"Null Hypothesis: Difference between change from baseline value of two treatment groups equals zero.~Alternate Hypothesis: Difference between change from baseline value of two treatment groups is not equal to zero."|F-Test|||9 Month Time point||||.0008
72338671|NCT00320372|144201209|SUPERIORITY_OR_OTHER|||||||0.0003|TWO_SIDED|||||"Null Hypothesis: Difference between change from baseline value of two treatment groups equals zero.~Alternate Hypothesis: Difference between change from baseline value of two treatment groups is not equal to zero."|F-Test|||12 Month Time point||||.0003
72338672|NCT00320372|144201209|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||"Null Hypothesis: Difference between change from baseline value of two treatment groups equals zero.~Alternate Hypothesis: Difference between change from baseline value of two treatment groups is not equal to zero."|F-Test|||18 Month Time point||||<.0001
72338673|NCT00320372|144201209|SUPERIORITY_OR_OTHER|||||||0.0059|TWO_SIDED|||||"Null Hypothesis: Difference between change from baseline value of two treatment groups equals zero.~Alternate Hypothesis: Difference between change from baseline value of two treatment groups is not equal to zero."|F-Test|||24 Month Time point||||.0059
72338674|NCT00320372|144201209|SUPERIORITY_OR_OTHER|||||||0.0028|TWO_SIDED|||||"Null Hypothesis: Difference between change from baseline value of two treatment groups equals zero.~Alternate Hypothesis: Difference between change from baseline value of two treatment groups is not equal to zero."|F-Test|||30 Month Time point||||.0028
72338675|NCT00320372|144201209|SUPERIORITY_OR_OTHER|||||||0.0002|TWO_SIDED|||||"Null Hypothesis: Difference between change from baseline value of two treatment groups equals zero.~Alternate Hypothesis: Difference between change from baseline value of two treatment groups is not equal to zero."|F-Test|||36 Month Time point||||.0002
72338676|NCT00320372|144201209|SUPERIORITY_OR_OTHER|||||||0.0051|TWO_SIDED|||||"Null Hypothesis: Difference between change from baseline value of two treatment groups equals zero.~Alternate Hypothesis: Difference between change from baseline value of two treatment groups is not equal to zero."|F-Test|||42 Month Time point||||.0051
72338677|NCT00320372|144201209|SUPERIORITY_OR_OTHER|||||||0.0363|TWO_SIDED|||||"Null Hypothesis: Difference between change from baseline value of two treatment groups equals zero.~Alternate Hypothesis: Difference between change from baseline value of two treatment groups is not equal to zero."|F-Test|||48 Month Time point||||.0363
72338678|NCT00320372|144201209|SUPERIORITY_OR_OTHER|||||||0.0048|TWO_SIDED|||||"Null Hypothesis: Difference between change from baseline value of two treatment groups equals zero.~Alternate Hypothesis: Difference between change from baseline value of two treatment groups is not equal to zero."|F-Test|||54 Month Time point||||.0048
72338679|NCT00320372|144201209|SUPERIORITY_OR_OTHER|||||||0.0009|TWO_SIDED|||||"Null Hypothesis: Difference between change from baseline value of two treatment groups equals zero.~Alternate Hypothesis: Difference between change from baseline value of two treatment groups is not equal to zero."|F-Test|||60 Month Time point||||.0009
72428222|NCT03954158|144367482|OTHER||Least squares mean of difference|-0.9|STANDARD_ERROR_OF_MEAN|0.42|||TWO_SIDED|95.0|-1.7|0.0||||||Change at Day 11, Intra-participant: Mixed effect model for repeated measures included the fixed effect of day, and the covariance structure UN was used.||0.0|-1.7|
72338680|NCT00320372|144201209|SUPERIORITY_OR_OTHER||MMRM Least Squares Mean|12.1009|||||TWO_SIDED|95.0|10.8979|13.3039|||||Mixed Model Repeated Measure analysis on Q-LES-Q change from baseline score (continuous var) as the response variable in the model. The covariates are treatment, visit and propensity quintile. This analysis of covariance produced least square means.|"Null Hypothesis: Difference between change from baseline value of two treatment groups equals zero.~Alternate Hypothesis: Difference between change from baseline value of two treatment groups is not equal to zero."||13.3039|10.8979|
72338681|NCT00320372|144201209|SUPERIORITY_OR_OTHER||MMRM Least Squares Mean|7.5964|||||TWO_SIDED|95.0|6.1327|9.0602|||||Mixed Model Repeated Measure analysis on Q-LES-Q change from baseline score (continuous var) as the response variable in the model. The covariates are treatment, visit and propensity quintile. This analysis of covariance produced least square means.|"Null Hypothesis: Difference between change from baseline value of two treatment groups equals zero.~Alternate Hypothesis: Difference between change from baseline value of two treatment groups is not equal to zero."||9.0602|6.1327|
72338682|NCT00320372|144201209|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|||"Null Hypothesis: Difference between change from baseline value of two treatment groups equals zero.~Alternate Hypothesis: Difference between change from baseline value of two treatment groups is not equal to zero."||||<.0001
72338683|NCT00320372|144201210|SUPERIORITY_OR_OTHER||Pearson Correlation Coefficients|0.14837|||<|0.0001|TWO_SIDED|||||"Null hypothesis: There is a correlation between MADRS follow-up suicidal thoughts and baseline medical threat to life.~Alternate hypothesis: There is no correlation between MADRS follow-up suicidal thoughts and baseline medical threat to life."|Pearson Correlation Coefficients|||The statistical modeling of predictors of suicide attempts and suicidal ideations considered 15 variables, defined in the protocol a priori to determine which ones were predictive of suicide attempts and suicidal ideations. Four variables representing the baseline disease and patient factors were considered predictors of suicidality. This outcome measure presents the underlying data collected and the corresponding correlation coefficient for one of the 4 variables identified.||||<.0001
72338684|NCT00320372|144201211|SUPERIORITY_OR_OTHER||Pearson Correlation Coefficients|0.14819|||<|0.0001|TWO_SIDED|||||"Null hypothesis: There is a correlation between MADRS f/u suicidal thoughts and baseline intent of suicidal gesture.~Alternate hypothesis: There is no correlation between MADRS f/u suicidal thoughts and baseline intent of suicidal gesture."|Pearson Correlation Coefficients|||The statistical modeling of predictors of suicide attempts and suicidal ideations considered 15 variables, defined in the protocol a priori to determine which ones were predictive of suicide attempts and suicidal ideations. Four variables representing the baseline disease and patient factors were considered predictors of suicidality. This outcome measure presents the underlying data collected and the corresponding correlation coefficient for one of the 4 variables identified.||||<.0001
72338685|NCT00320372|144201212|SUPERIORITY_OR_OTHER||Pearson Correlation Coefficients|0.04625||||0.0012|TWO_SIDED|||||"Null hypothesis: There is a correlation between MADRS follow-up suicidal thoughts and baseline primary diagnosis of MDE.~Alternate hypothesis: There is no correlation between MADRS follow-up suicidal thoughts and baseline primary diagnosis of MDE."|Pearson Correlation Coefficients|||The statistical modeling of predictors of suicide attempts and suicidal ideations considered 15 variables, defined in the protocol a priori to determine which ones were predictive of suicide attempts and suicidal ideations. Four variables representing the baseline disease and patient factors were considered predictors of suicidality. This outcome measure presents the underlying data collected and the corresponding correlation coefficient for one of the 4 variables identified.||||.0012
72338686|NCT00086502|144201213|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.7|STANDARD_DEVIATION|0.73|<|0.001||95.0|-0.85|-0.54||"Model terms: treatment; baseline; prior antihyperglycemic~agent (AHA) therapy \[not on AHA, monotherapy with oral AHA, peroxisome proliferator-activated receptor (PPAR)-based combination therapy\]"|ANCOVA|||||-0.54|-0.85|<0.001
72338687|NCT00086502|144201214|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-17.7|STANDARD_DEVIATION|30.9|<|0.001||95.0|-24.3|-11.0||Model terms: treatment; baseline; prior antihyperglycemic agent (AHA) therapy \[not on AHA, monotherapy with oral AHA, peroxisome proliferator-activated receptor (PPAR)-based combination therapy\]|ANCOVA|||||-11.0|-24.3|<0.001
72338688|NCT01304329|144201215|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability|Geometric Mean Ratio|102.05|STANDARD_DEVIATION|5.4|||TWO_SIDED|90.0|98.9|105.29|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment.|Standard deviation is actually the geometric coefficient of variation (gCV)|Considered characteristic is empa plus simvastatin divided by empa alone||105.29|98.90|
72428223|NCT03954158|144367482|OTHER||Least squares mean of difference|-1.5|STANDARD_ERROR_OF_MEAN|0.38|||TWO_SIDED|95.0|-2.3|-0.7||||||Change at Day 11, Intra-participant: MMRM included the fixed effect of day, and the covariance structure UN was used.||-0.7|-2.3|
72338689|NCT01304329|144201216|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability|Geometric Mean Ratio|101.26|STANDARD_DEVIATION|40.4|||TWO_SIDED|90.0|80.06|128.07|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment.|Standard deviation is actually the gCV|"AUC of simvastatin~Considered characteristic is empa plus simvastatin divided by simvastatin alone"||128.07|80.06|
72338690|NCT01304329|144201216|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability|Geometric Mean Ratio|104.87|STANDARD_DEVIATION|25.5|||TWO_SIDED|90.0|90.09|122.07|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment.|Standard deviation is actually the gCV|"AUC of simvastatin acid~Considered characteristic is empa plus simvastatin divided by simvastatin alone."||122.07|90.09|
72338691|NCT01304329|144201217|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability|Geometric Mean Ratio|109.49|STANDARD_DEVIATION|21.1|||TWO_SIDED|90.0|96.91|123.69|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment.|Standard deviation is actually the gCV|Considered characteristic is empa plus simvastatin divided by empa alone||123.69|96.91|
72338692|NCT01304329|144201218|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability|Geometric Mean Ratio|97.18|STANDARD_DEVIATION|41.7|||TWO_SIDED|90.0|76.3|123.77|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment.|Standard deviation is actually the gCV|"Cmax of simvastatin.~Considered characteristic is empa plus simvastatin divided by simvastatin alone."||123.77|76.30|
72338693|NCT01304329|144201218|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability|Geometric Mean Ratio|97.27|STANDARD_DEVIATION|22.7|||TWO_SIDED|90.0|84.9|111.44|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment.|Standard deviation is actually the gCV|"Cmax of simvastatin acid.~Considered characteristic is empa plus simvastatin divided by simvastatin alone."||111.44|84.90|
72338694|NCT01304329|144201219|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability|Geometric Mean Ratio|102.52|STANDARD_DEVIATION|5.8|||TWO_SIDED|90.0|99.1|106.06|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment.|Standard deviation is actually the gCV|Considered characteristic is empa plus simvastatin divided by empa alone.||106.06|99.10|
72338695|NCT01304329|144201220|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability|Geometric Mean Ratio|102.34|STANDARD_DEVIATION|41.7|||TWO_SIDED|90.0|80.39|130.29|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment.|Standard deviation is actually the gCV|"AUC of simvastatin.~Considered characteristic is empa plus simvastatin divided by simvastatin alone."||130.29|80.39|
72338696|NCT01304329|144201220|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability|Geometric Mean Ratio|111.25|STANDARD_DEVIATION|24.8|||TWO_SIDED|90.0|95.93|129.02|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment.|Standard deviation is actually the gCV|"AUC of simvastatin acid.~Considered characteristic is empa plus simvastatin divided by simvastatin alone."||129.02|95.93|
72338697|NCT02575118|144201225|OTHER||||||<|0.05|||||||linear mixed-effects regression models|All available data, and hence data for participants with missing observations at some time points, were included in the model.||In one saliva sample collected before treatment, the BPA concentration was more than 100 times higher (11.6 ng/ml) than the mean value and more than 100 SD from the mean of the remaining 19 samples. This saliva sample was excluded from the statistical analysis because it was probably contaminated. One participant had breakfast before the sample time point 1 wk after treatment, and thus the samples collected from this participant at this time point were not included in the statistical analysis.|We used mixed effects models and all available data (also data for participants with missing observations at some time points) were included in the model. Using mixed effects models is a recognized method when there are missing data. Thus, data from all 20 individuals were used for estimations at all time points (see: Rabe-Hesketh and Skrondal. Multilevel and Longitudinal Modeling Using Stata, Volume I, Third Edition. 2012, page 279).|||<0.05
72338698|NCT02575118|144201226|OTHER||||||<|0.05|||||||linear mixed-effects regression models|All available data, and hence data for participants with missing observations at some time points, were included in the model.||One participant had breakfast before the sample time point 1 wk after treatment, and thus the samples collected from this participant at this time point were not included in the statistical analysis.|We used mixed effects models and all available data (also data for participants with missing observations at some time points), were included in the model. Using mixed effects models is a recognized method when there are missing data. Thus, data from all 20 individuals were used for estimations at all time points (see: Rabe-Hesketh and Skrondal. Multilevel and Longitudinal Modeling Using Stata, Volume I, Third Edition. 2012, page 279).|||<0.05
72338699|NCT02068118|144201229|SUPERIORITY||rate ratio|0.97|||=|0.8|TWO_SIDED|95.0|0.77|1.23|||negative binomial regression|||"Number of events compared using a negative binomial regression model with log link for the expected rate of events (i.e., number of events divided by the effective duration of follow-up).~Deaths that occurred during hospitalization with an overnight stay were counted as two events."||1.23|0.77|=0.80
72338700|NCT02068118|144201230|SUPERIORITY||rate ratio|0.82|||=|0.18|TWO_SIDED|95.0|0.62|1.1|||negative binomial regression|||"Number of events compared using a negative binomial regression model with log link for the expected rate of events (i.e., number of events divided by the effective duration of follow-up).~Deaths that occurred during hospitalization with an overnight stay were counted as two events."||1.10|0.62|=0.18
72338701|NCT02068118|144201231|SUPERIORITY||rate ratio|0.6|||=|0.02|TWO_SIDED|95.0|0.39|0.92|||negative binomial regression|||"Number of events compared using a negative binomial regression model with log link for the expected rate of events (i.e., number of events divided by the effective duration of follow-up).~Deaths that occurred during hospitalization with an overnight stay were counted as two events."||0.92|0.39|=0.02
72338702|NCT02068118|144201232|SUPERIORITY||||||=|0.68|||||||Log Rank|||Time to first event compared using the log-rank test||||=0.68
72338703|NCT02068118|144201234|SUPERIORITY||||||=|0.85|||||||Log Rank|||Time to death from any cause compared using the log-rank test||||=0.85
72338704|NCT02068118|144201235|SUPERIORITY||rate ratio|0.97|||=|0.77|TWO_SIDED|95.0|0.78|1.21|||negative binomial regression|||Number of events compared using a negative binomial regression model with log link for the expected rate of events (i.e., number of events divided by the effective duration of follow-up).||1.21|0.78|=0.77
72338705|NCT02068118|144201236|SUPERIORITY||rate ratio|0.97|||=|0.83|TWO_SIDED|95.0|0.74|1.27|||negative binomial regression|||"Number of events compared using a negative binomial regression model with log link for the expected rate of events (i.e., number of events divided by the effective duration of follow-up).~Deaths from cardiovascular cause that occurred during a hospitalization for cardiovascular cause with an overnight stay were counted as two events."||1.27|0.74|=0.83
72338706|NCT02068118|144201237|SUPERIORITY||rate ratio|0.84|||=|0.28|TWO_SIDED|95.0|0.62|1.15|||negative binomial regression|||Number of events compared using a negative binomial regression model with log link for the expected rate of events (i.e., number of events divided by the effective duration of follow-up)||1.15|0.62|=0.28
72338707|NCT02068118|144201238|SUPERIORITY||rate ratio|0.71|||=|0.078|TWO_SIDED|95.0|0.48|1.04|||negative binomial regression|||Number of events compared using a negative binomial regression model with log link for the expected rate of events (i.e., number of events divided by the effective duration of follow-up)||1.04|0.48|=0.078
72428224|NCT03954158|144367482|OTHER||Difference of Least Squares Mean|0.2|STANDARD_ERROR_OF_MEAN|0.44|||TWO_SIDED|95.0|-0.7|1.1||||||Change at Day 11, Inter-participant: Mixed effect Model for Repeated Measures included the fixed effects of dosing regimen, day, dosing regimen-by-day interaction, and baseline value, and the covariance structure UN was used.||1.1|-0.7|
72428225|NCT03954158|144367482|OTHER||Least squares mean of difference|-1.3|STANDARD_ERROR_OF_MEAN|0.34|||TWO_SIDED|95.0|-2.0|-0.5||||||Change at Day 12, Intra-participant: Mixed effect model for repeated measures included the fixed effect of day, and the covariance structure UN was used.||-0.5|-2.0|
72338708|NCT02068118|144201239|SUPERIORITY||rate ratio|0.5|||=|0.023|TWO_SIDED|95.0|0.28|0.91|||negative binomial regression|||Number of events compared using a negative binomial regression model with log link for the expected rate of events (i.e., number of events divided by the effective duration of follow-up)||0.91|0.28|=0.023
72428226|NCT03954158|144367482|OTHER||Least squares mean of difference|-1.0|STANDARD_ERROR_OF_MEAN|0.47|||TWO_SIDED|95.0|-2.0|0.0||||||Change at Day 12, Intra-participant: Mixed effect model for repeated measures included the fixed effect of day, and the covariance structure UN was used.||0.0|-2.0|
72428227|NCT03954158|144367482|OTHER||Difference of Least Squares Mean|0.1|STANDARD_ERROR_OF_MEAN|0.52|||TWO_SIDED|95.0|-0.9|1.2||||||Change at Day 12, Inter-participant: Mixed effect Model for Repeated Measures included the fixed effects of dosing regimen, day, dosing regimen-by-day interaction, and baseline value, and the covariance structure UN was used.||1.2|-0.9|
72428228|NCT03954158|144367482|OTHER||Least squares mean of difference|-1.1|STANDARD_ERROR_OF_MEAN|0.35|||TWO_SIDED|95.0|-1.8|-0.3||||||Change at Day 13, Intra-participant: Mixed effect model for repeated measures included the fixed effect of day, and the covariance structure UN was used.||-0.3|-1.8|
72428229|NCT03954158|144367482|OTHER||Least squares mean of difference|-1.0|STANDARD_ERROR_OF_MEAN|0.47|||TWO_SIDED|95.0|-2.0|-0.1||||||Change at Day 13, Intra-participant: Mixed effect model for repeated measures included the fixed effect of day, and the covariance structure UN was used.||-0.1|-2.0|
72428230|NCT03954158|144367482|OTHER||Difference of Least Squares Mean|-0.2|STANDARD_ERROR_OF_MEAN|0.53|||TWO_SIDED|95.0|-1.3|0.9||||||Change at Day 13, Inter-participant: Mixed effect Model for Repeated Measures included the fixed effects of dosing regimen, day, dosing regimen-by-day interaction, and baseline value, and the covariance structure UN was used.||0.9|-1.3|
72428231|NCT03954158|144367482|OTHER||Least squares mean of difference|-1.2|STANDARD_ERROR_OF_MEAN|0.31|||TWO_SIDED|95.0|-1.9|-0.5||||||Change at Day 14, Intra-participant: Mixed effect model for repeated measures included the fixed effect of day, and the covariance structure UN was used.||-0.5|-1.9|
72428232|NCT03954158|144367482|OTHER||Least squares mean of difference|-1.0|STANDARD_ERROR_OF_MEAN|0.42|||TWO_SIDED|95.0|-1.8|-0.1||||||Change at Day 14, Intra-participant: Mixed effect model for repeated measures included the fixed effect of day, and the covariance structure UN was used.||-0.1|-1.8|
72428233|NCT03954158|144367482|OTHER||Difference of Least Squares Mean|-0.4|STANDARD_ERROR_OF_MEAN|0.53|||TWO_SIDED|95.0|-1.5|0.7||||||Change at Day 14, Inter-participant: Mixed effect Model for Repeated Measures included the fixed effects of dosing regimen, day, dosing regimen-by-day interaction, and baseline value, and the covariance structure UN was used.||0.7|-1.5|
72428234|NCT03954158|144367482|OTHER||Least squares mean of difference|-1.5|STANDARD_ERROR_OF_MEAN|0.34|||TWO_SIDED|95.0|-2.2|-0.8||||||Change at Day 15, Intra-participant: Mixed effect model for repeated measures included the fixed effect of day, and the covariance structure UN was used.||-0.8|-2.2|
72428235|NCT03954158|144367482|OTHER||Least squares mean of difference|-0.8|STANDARD_ERROR_OF_MEAN|0.36|||TWO_SIDED|95.0|-1.5|0.0||||||Change at Day 15, Intra-participant: Mixed effect model for repeated measures included the fixed effect of visit, and the covariance structure UN was used.||0.0|-1.5|
72428236|NCT03954158|144367482|OTHER||Difference of least square mean|-0.3|STANDARD_ERROR_OF_MEAN|0.53|||TWO_SIDED|95.0|-1.4|0.8||||||Change at Day 15, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen, day, dosing regimen-by-day interaction, and baseline value and the covariance structure UN was used.||0.8|-1.4|
72428237|NCT03954158|144367483|OTHER||Least squares mean of difference|-0.4|STANDARD_ERROR_OF_MEAN|0.27|||TWO_SIDED|95.0|-1.0|0.2||||||Change at Day 2, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.||0.2|-1.0|
72338709|NCT02068118|144201240|SUPERIORITY||Hazard Ratio (HR)|0.79|||=|0.044|TWO_SIDED|95.0|0.62|0.99|||Regression, Cox|||Time to first unplanned hospital readmission for heart failure compared using multivariable Cox regression model||0.99|0.62|=0.044
72428238|NCT03954158|144367483|OTHER||Least squares mean of difference|-0.3|STANDARD_ERROR_OF_MEAN|0.41|||TWO_SIDED|95.0|-1.1|0.5||||||Change at Day 2, Intra-participant: Mixed effect model for repeated measures includes the fixed effect of day and the covariance structure AR1 is used.||0.5|-1.1|
72428239|NCT03954158|144367483|OTHER||Difference of least squares mean|0.3|STANDARD_ERROR_OF_MEAN|0.4|||TWO_SIDED|95.0|-0.5|1.1||||||Change at Day 2, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen day dosing regimen-by-day interaction and baseline value and the covariance structure UN was used.||1.1|-0.5|
72428240|NCT03954158|144367483|OTHER||Least squares mean of difference|0.1|STANDARD_ERROR_OF_MEAN|0.3|||TWO_SIDED|95.0|-0.6|0.7||||||Change at Day 3, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.||0.7|-0.6|
72428241|NCT03954158|144367483|OTHER||Least squares mean of difference|-0.6|STANDARD_ERROR_OF_MEAN|0.41|||TWO_SIDED|95.0|-1.5|0.2||||||Change at Day 3, Intra-participant: Mixed effect model for repeated measures includes the fixed effect of day and the covariance structure AR1 is used.||0.2|-1.5|
72428242|NCT03954158|144367483|OTHER||Difference of least squares mean|-0.2|STANDARD_ERROR_OF_MEAN|0.36|||TWO_SIDED|95.0|-1.0|0.5||||||Change at Day 3, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen day dosing regimen-by-day interaction and baseline value and the covariance structure UN was used.||0.5|-1.0|
72428243|NCT03954158|144367483|OTHER||Least squares mean of difference|0.0|STANDARD_ERROR_OF_MEAN|0.52|||TWO_SIDED|96.0|-1.1|1.1||||||Change at Day 4, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.||1.1|-1.1|
72428244|NCT03954158|144367483|OTHER||Least squares mean of difference|0.0|STANDARD_ERROR_OF_MEAN|0.41|||TWO_SIDED|95.0|-0.8|0.8||||||Change at Day 4, Intra-participant: Mixed effect model for repeated measures includes the fixed effect of day and the covariance structure AR1 is used.||0.8|-0.8|
72338710|NCT02068118|144201241|SUPERIORITY||Adjusted Means Difference|1.06|||=|0.17|TWO_SIDED|95.0|-2.48|4.61||Study group effect over time|Mixed Models Analysis|||ANCOVA Physical Functioning score: Parametric analysis of covariance mixed model on repeated measurements (Baseline, 12 and 18 months) with physical functioning score assessed at baseline as covariate, study group and visit as fixed factors, interaction between study group and visit, interaction between study group and score assessed at baseline and patient as random factor||4.61|-2.48|=0.17
72338711|NCT02068118|144201241|SUPERIORITY||Adjusted Means Difference|1.8|||=|0.23|TWO_SIDED|95.0|-2.61|6.21||Study group effect over time|Mixed Models Analysis|||ANCOVA Role Physical score: Parametric analysis of covariance mixed model on repeated measurements (Baseline, 12 and 18 months) with role physical score assessed at baseline as covariate, study group and visit as fixed factors, interaction between study group and visit, interaction between study group and score assessed at baseline and patient as random factor||6.21|-2.61|=0.23
72428245|NCT03954158|144367483|OTHER||Difference of least squares mean|0.0|STANDARD_ERROR_OF_MEAN|0.43|||TWO_SIDED|95.0|-0.9|0.8||||||Change at Day 4, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen day dosing regimen-by-day interaction and baseline value and the covariance structure UN was used.||0.8|-0.9|
72428246|NCT03954158|144367483|OTHER||Least squares mean of difference|-0.4|STANDARD_ERROR_OF_MEAN|0.36|||TWO_SIDED|95.0|-1.2|0.3||||||Change at Day 5, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.||0.3|-1.2|
72428247|NCT03954158|144367483|OTHER||Least squares mean of difference|-0.4|STANDARD_ERROR_OF_MEAN|0.41|||TWO_SIDED|95.0|-1.2|0.4||||||Change at Day 5, Intra-participant: Mixed effect model for repeated measures includes the fixed effect of day and the covariance structure AR1 is used.||0.4|-1.2|
72428248|NCT03954158|144367483|OTHER||Difference of least squares mean|0.1|STANDARD_ERROR_OF_MEAN|0.44|||TWO_SIDED|95.0|-0.8|1.0||||||Change at Day 5, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen day dosing regimen-by-day interaction and baseline value and the covariance structure UN was used.||1.0|-0.8|
72428249|NCT03954158|144367483|OTHER||Least squares mean of difference|-0.3|STANDARD_ERROR_OF_MEAN|0.42|||TWO_SIDED|95.0|-1.2|0.6||||||Change at Day 6, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.||0.6|-1.2|
72428250|NCT03954158|144367483|OTHER||Least squares mean of difference|-0.1|STANDARD_ERROR_OF_MEAN|0.41|||TWO_SIDED|95.0|-0.9|0.7||||||Change at Day 6, Intra-participant: Mixed effect model for repeated measures includes the fixed effect of day and the covariance structure AR1 is used.||0.7|-0.9|
72428251|NCT03954158|144367483|OTHER||Difference of least squares mean|0.1|STANDARD_ERROR_OF_MEAN|0.33|||TWO_SIDED|95.0|-0.5|0.8||||||Change at Day 6, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen day dosing regimen-by-day interaction and baseline value and the covariance structure UN was used.||0.8|-0.5|
72428252|NCT03954158|144367483|OTHER||Least squares mean of difference|-0.1|STANDARD_ERROR_OF_MEAN|0.43|||TWO_SIDED|95.0|-1.0|0.9||||||Change at Day 7, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.||0.9|-1.0|
72338712|NCT02068118|144201241|SUPERIORITY||Adjusted Means Difference|4.46|||=|0.5|TWO_SIDED|95.0|0.59|8.33||Study group effect over time|Mixed Models Analysis|||ANCOVA Bodily Pain score: Parametric analysis of covariance mixed model on repeated measurements (Baseline, 12 and 18 months) with bodily pain score assessed at baseline as covariate, study group and visit as fixed factors, interaction between study group and visit, interaction between study group and score assessed at baseline and patient as random factor||8.33|0.59|=0.50
72428253|NCT03954158|144367483|OTHER||Least squares mean of difference|-0.1|STANDARD_ERROR_OF_MEAN|0.41|||TWO_SIDED|95.0|-1.0|0.7||||||Change at Day 7, Intra-participant: Mixed effect model for repeated measures includes the fixed effect of day and the covariance structure AR1 is used.||0.7|-1.0|
72428254|NCT03954158|144367483|OTHER||Difference of least squares mean|-0.4|STANDARD_ERROR_OF_MEAN|0.42|||TWO_SIDED|95.0|-1.2|0.5||||||Change at Day 7, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen day dosing regimen-by-day interaction and baseline value and the covariance structure UN was used.||0.5|-1.2|
72428255|NCT03954158|144367483|OTHER||Least squares mean of difference|-0.4|STANDARD_ERROR_OF_MEAN|0.42|||TWO_SIDED|95.0|-1.3|0.5||||||Change at Day 8, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.||0.5|-1.3|
72428256|NCT03954158|144367483|OTHER||Least squares mean of difference|-0.6|STANDARD_ERROR_OF_MEAN|0.41|||TWO_SIDED|95.0|-1.4|0.2||||||Change at Day 8, Intra-participant: Mixed effect model for repeated measures includes the fixed effect of day and the covariance structure AR1 is used.||0.2|-1.4|
72428257|NCT03954158|144367483|OTHER||Difference of least squares mean|0.2|STANDARD_ERROR_OF_MEAN|0.32|||TWO_SIDED|95.0|-0.5|0.8||||||Change at Day 8, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen day dosing regimen-by-day interaction and baseline value and the covariance structure UN was used.||0.8|-0.5|
72428258|NCT03954158|144367483|OTHER||Least squares mean of difference|-0.3|STANDARD_ERROR_OF_MEAN|0.44|||TWO_SIDED|95.0|-1.2|0.6||||||Change at Day 9, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.||0.6|-1.2|
72428259|NCT03954158|144367483|OTHER||Least squares mean of difference|-0.4|STANDARD_ERROR_OF_MEAN|0.41|||TWO_SIDED|95.0|-1.2|0.4||||||Change at Day 9, Intra-participant: Mixed effect model for repeated measures includes the fixed effect of day and the covariance structure AR1 is used.||0.4|-1.2|
72428260|NCT03954158|144367483|OTHER||Difference of least squares mean|-0.6|STANDARD_ERROR_OF_MEAN|0.33|||TWO_SIDED|95.0|-1.2|0.1||||||Change at Day 9, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen day dosing regimen-by-day interaction and baseline value and the covariance structure UN was used.||0.1|-1.2|
72428261|NCT03954158|144367483|OTHER||Least squares mean of difference|-0.3|STANDARD_ERROR_OF_MEAN|0.45|||TWO_SIDED|95.0|-1.3|0.7||||||Change at Day 10, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.||0.7|-1.3|
72428262|NCT03954158|144367483|OTHER||Least squares mean of difference|-0.2|STANDARD_ERROR_OF_MEAN|0.41|||TWO_SIDED|95.0|-1.0|0.6||||||Change at Day 10, Intra-participant: Mixed effect model for repeated measures includes the fixed effect of day and the covariance structure AR1 is used.||0.6|-1.0|
72428263|NCT03954158|144367483|OTHER||Difference of least squares mean|-0.1|STANDARD_ERROR_OF_MEAN|0.31|||TWO_SIDED|95.0|-0.8|0.5||||||Change at Day 10, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen day dosing regimen-by-day interaction and baseline value and the covariance structure UN was used.||0.5|-0.8|
72428264|NCT03954158|144367483|OTHER||Least squares mean of difference|-0.6|STANDARD_ERROR_OF_MEAN|0.45|||TWO_SIDED|95.0|-1.6|0.3||||||Change at Day 11, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.||0.3|-1.6|
72338713|NCT02068118|144201241|SUPERIORITY||Adjusted Means Difference|2.52|||=|0.19|TWO_SIDED|95.0|-0.07|5.12||Study group effect over time|Mixed Models Analysis|||ANCOVA General Health score: Parametric analysis of covariance mixed model on repeated measurements (Baseline, 12 and 18 months) with general health score assessed at baseline as covariate, study group and visit as fixed factors, interaction between study group and visit, interaction between study group and score assessed at baseline and patient as random factor||5.12|-0.07|=0.19
72338714|NCT02068118|144201241|SUPERIORITY||Adjusted Means Difference|2.38|||=|0.034|TWO_SIDED|95.0|-0.09|4.85||Study group effect over time|Mixed Models Analysis|||ANCOVA Vitality score: Parametric analysis of covariance mixed model on repeated measurements (Baseline, 12 and 18 months) with vitality score assessed at baseline as covariate, study group and visit as fixed factors, interaction between study group and visit, interaction between study group and score assessed at baseline and patient as random factor||4.85|-0.09|=0.034
72338715|NCT02068118|144201241|SUPERIORITY||Adjusted Means Difference|4.03|||=|0.025|TWO_SIDED|95.0|0.6|7.47||Study group effect over time|Mixed Models Analysis|||ANCOVA Social Functioning score: Parametric analysis of covariance mixed model on repeated measurements (Baseline, 12 and 18 months) with social functioning score assessed at baseline as covariate, study group and visit as fixed factors, interaction between study group and visit, interaction between study group and score assessed at baseline and patient as random factor||7.47|0.60|=0.025
72338716|NCT02068118|144201241|SUPERIORITY||Adjusted Means Difference|1.01|||=|0.9|TWO_SIDED|95.0|-2.79|4.81||Study group effect over time|Mixed Models Analysis|||ANCOVA Role Emotional score: Parametric analysis of covariance mixed model on repeated measurements (Baseline, 12 and 18 months) with role emotional score assessed at baseline as covariate, study group and visit as fixed factors, interaction between study group and visit, interaction between study group and score assessed at baseline and patient as random factor||4.81|-2.79|=0.90
72338717|NCT02068118|144201241|SUPERIORITY||Adjusted Means Difference|2.26|||=|0.19|TWO_SIDED|95.0|0.16|4.37||Study group effect over time|Mixed Models Analysis|||ANCOVA Mental Health score: Parametric analysis of covariance mixed model on repeated measurements (Baseline, 12 and 18 months) with mental health score assessed at baseline as covariate, study group and visit as fixed factors, interaction between study group and visit, interaction between study group and score assessed at baseline and patient as random factor||4.37|0.16|=0.19
72338718|NCT02068118|144201241|SUPERIORITY||Adjusted Means Difference|0.9|||=|0.26|TWO_SIDED|95.0|-0.48|2.28||Study group effect over time|Mixed Models Analysis|||ANCOVA Physical Component Summary (PCS) score: Parametric analysis of covariance mixed model on repeated measurements (Baseline, 12 and 18 months) with PCS score assessed at baseline as covariate, study group and visit as fixed factors, interaction between study group and visit, interaction between study group and score assessed at baseline and patient as random factor||2.28|-0.48|=0.26
72338719|NCT02068118|144201241|SUPERIORITY||Adjusted Means Difference|1.2|||=|0.17|TWO_SIDED|95.0|0.08|2.31||Study group effect over time|Mixed Models Analysis|||ANCOVA Mental Component Summary (MCS) score: Parametric analysis of covariance mixed model on repeated measurements (Baseline, 12 and 18 months) with MCS score assessed at baseline as covariate, study group and visit as fixed factors, interaction between study group and visit, interaction between study group and score assessed at baseline and patient as random factor||2.31|0.08|=0.17
72338720|NCT02068118|144201246|SUPERIORITY||||||=|0.03|||||||Log Rank|||Time to first event compared using the log-rank test||||=0.03
72338721|NCT02068118|144201247|SUPERIORITY||||||=|0.15|||||||Log Rank|||Time to first event compared using the log-rank test||||=0.15
72338722|NCT02068118|144201248|SUPERIORITY||Hazard Ratio (HR)|0.71|||=|0.02|TWO_SIDED|95.0|0.53|0.95|||Regression, Cox|||Time to first unplanned hospital readmission for heart failure compared using multivariable Cox regression model||0.95|0.53|=0.02
72338723|NCT02068118|144201249|SUPERIORITY||Hazard Ratio (HR)|0.62|||=|0.043|TWO_SIDED|95.0|0.39|0.98|||Regression, Cox|||Time to first unplanned hospital readmission for heart failure compared using multivariable Cox regression model||0.98|0.39|=0.043
72338724|NCT04883528|144201250|SUPERIORITY|||||||0.29|||||||Mixed Models Analysis|||||||0.29
72338725|NCT04883528|144201251|SUPERIORITY|||||||0.88|||||||Mixed Models Analysis|||||||0.88
72338726|NCT04883528|144201252|SUPERIORITY|||||||0.76|||||||Mixed Models Analysis|||||||0.76
72338727|NCT04883528|144201253|SUPERIORITY|||||||0.85|||||||Mixed Models Analysis|||||||0.85
72338728|NCT04883528|144201254|SUPERIORITY|||||||0.8|||||||Mixed Models Analysis|||||||0.80
72338729|NCT04883528|144201255|SUPERIORITY|||||||0.01|||||||Mixed Models Analysis|||||||0.01
72338730|NCT04883528|144201256|SUPERIORITY|||||||0.23|||||||Mixed Models Analysis|||||||0.23
72338731|NCT04883528|144201257|SUPERIORITY|||||||0.95|||||||Mixed Models Analysis|||||||0.95
72338732|NCT04883528|144201258|SUPERIORITY|||||||0.03|||||||Mixed Models Analysis|||||||0.03
72338733|NCT04883528|144201262|SUPERIORITY||Least squares mean difference|-0.01||||0.64|TWO_SIDED|95.0|-0.07|0.04|||Mixed Models Analysis|||||0.04|-0.07|0.64
72338734|NCT04883528|144201263|SUPERIORITY||Least squares mean difference|-7.55||||0.04|TWO_SIDED|95.0|-14.59|0.52|||Mixed Models Analysis|||||0.52|-14.59|0.04
72338735|NCT01996592|144201277|OTHER||||||<|0.01||||||p-value was calculated|ANOVA|||"PROMIS -perceived stress scale was utilized (a validated test). Scoring ranges from 0-40, with the following ranges indicative of low, moderate, or high perceived stress:~0-13=low stress 14-26=moderate stress 27-40=high perceived stress"||||<0.01
72338736|NCT01996592|144201278|OTHER||||||<|0.01||||||p-value was calculated|ANOVA|||||||<0.01
72338737|NCT00394901|144201284|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.31||||0.262||95.0|-0.85|0.23|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||0.23|-0.85|0.262
72338738|NCT00394901|144201284|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.86||||0.002||95.0|-1.39|-0.32|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.32|-1.39|0.002
72338739|NCT00394901|144201284|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.63||||0.019||95.0|-1.15|-0.1|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.10|-1.15|0.019
72338740|NCT00394901|144201285|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.64||||0.016||95.0|-1.16|-0.12|||ANCOVA|The model included treatment group modified based on the expected pregabalin exposure as a factor, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.12|-1.16|0.016
72338741|NCT00394901|144201285|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.66||||0.008||95.0|-1.14|-0.17|||ANCOVA|The model included treatment group modified based on the expected pregabalin exposure as a factor, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.17|-1.14|0.008
72338742|NCT00394901|144201286|SUPERIORITY_OR_OTHER_LEGACY|||||||0.116||95.0|||||Cochran-Mantel-Haenszel|stratified by CLcr stratum||Proportion of responders were used for the statistical analyses. Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||||0.1160
72428265|NCT03954158|144367483|OTHER||Difference of least squares mean|0.3|STANDARD_ERROR_OF_MEAN|0.36|||TWO_SIDED|95.0|-0.4|1.0||||||Change at Day 11, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen day dosing regimen-by-day interaction and baseline value and the covariance structure UN was used.||1.0|-0.4|
72428266|NCT03954158|144367483|OTHER||Least squares mean of difference|-0.4|STANDARD_ERROR_OF_MEAN|0.41|||TWO_SIDED|95.0|-1.2|0.5||||||Change at Day 11, Intra-participant: Mixed effect model for repeated measures includes the fixed effect of day and the covariance structure AR1 is used.||0.5|-1.2|
72428267|NCT03954158|144367483|OTHER||Least squares mean of difference|-0.9|STANDARD_ERROR_OF_MEAN|0.43|||TWO_SIDED|95.0|-1.9|0.0||||||Change at Day 12, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.||0.0|-1.9|
72428268|NCT03954158|144367483|OTHER||Least squares mean of difference|-0.6|STANDARD_ERROR_OF_MEAN|0.41|||TWO_SIDED|95.0|-1.5|0.2||||||Change at Day 12, Intra-participant: Mixed effect model for repeated measures includes the fixed effect of day and the covariance structure AR1 is used.||0.2|-1.5|
72428269|NCT03954158|144367483|OTHER||Difference of least squares mean|-0.3|STANDARD_ERROR_OF_MEAN|0.37|||TWO_SIDED|95.0|-1.0|0.5||||||Change at Day 12, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen day dosing regimen-by-day interaction and baseline value and the covariance structure UN was used.||0.5|-1.0|
72428270|NCT03954158|144367483|OTHER||Least squares mean of difference|-0.6|STANDARD_ERROR_OF_MEAN|0.44|||TWO_SIDED|95.0|-1.5|0.4||||||Change at Day 13, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.||0.4|-1.5|
72428271|NCT03954158|144367483|OTHER||Least squares mean of difference|-0.6|STANDARD_ERROR_OF_MEAN|0.41|||TWO_SIDED|95.0|-1.5|0.2||||||Change at Day 13, Intra-participant: Mixed effect model for repeated measures includes the fixed effect of day and the covariance structure AR1 is used.||0.2|-1.5|
72428272|NCT03954158|144367483|OTHER||Least squares mean|-0.4|STANDARD_ERROR_OF_MEAN|0.34|||TWO_SIDED|95.0|-1.1|0.3||||||Change at Day 13, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen day dosing regimen-by-day interaction and baseline value and the covariance structure UN was used.||0.3|-1.1|
72428273|NCT03954158|144367483|OTHER||Least squares mean of difference|-0.5|STANDARD_ERROR_OF_MEAN|0.42|||TWO_SIDED|95.0|-1.4|0.4||||||Change at Day 14, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.||0.4|-1.4|
72338743|NCT00394901|144201286|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0015||95.0|||||Cochran-Mantel-Haenszel|stratified by CLcr stratum||Proportion of responders were used for the statistical analyses. Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||||0.0015
72338744|NCT00394901|144201286|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0107||95.0|||||Cochran-Mantel-Haenszel|stratified by CLcr stratum||Proportion of responders were used for the statistical analyses. Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||||0.0107
72338745|NCT00394901|144201287|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.51||||0.038||95.0|-0.99|-0.03|||repeated measures analysis|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.03|-0.99|0.038
72338746|NCT00394901|144201287|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.75||||0.002||95.0|-1.22|-0.27|||repeated measures analysis|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.27|-1.22|0.002
72338747|NCT00394901|144201287|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.72||||0.002||95.0|-1.19|-0.26|||repeated measures analysis|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.26|-1.19|0.002
72428274|NCT03954158|144367483|OTHER||Least squares mean of difference|-0.3|STANDARD_ERROR_OF_MEAN|0.41|||TWO_SIDED|95.0|-1.1|0.5||||||Change at Day 14, Intra-participant: Mixed effect model for repeated measures includes the fixed effect of day and the covariance structure AR1 is used.||0.5|-1.1|
72428275|NCT03954158|144367483|OTHER||Difference of least squares mean|-0.2|STANDARD_ERROR_OF_MEAN|0.39|||TWO_SIDED|95.0|-1.0|0.6||||||Change at Day 14, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen day dosing regimen-by-day interaction and baseline value and the covariance structure UN was used.||0.6|-1.0|
72428276|NCT03954158|144367483|OTHER||Least squares mean of difference|-0.2|STANDARD_ERROR_OF_MEAN|0.34|||TWO_SIDED|95.0|-0.9|0.5||||||Change at Day 15, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.||0.5|-0.9|
72428277|NCT03954158|144367483|OTHER||Least squares mean of difference|-0.4|STANDARD_ERROR_OF_MEAN|0.41|||TWO_SIDED|95.0|-1.2|0.5||||||Change at Day 15, Intra-participant: Mixed effect model for repeated measures includes the fixed effect of day and the covariance structure AR1 is used.||0.5|-1.2|
72428278|NCT03954158|144367483|OTHER||Difference of least squares mean|-0.2|STANDARD_ERROR_OF_MEAN|0.39|||TWO_SIDED|95.0|-1.0|0.6||||||Change at Day 15, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen day dosing regimen-by-day interaction and baseline value and the covariance structure UN was used.||0.6|-1.0|
72338748|NCT00394901|144201288|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.48||||0.048||95.0|-0.97|0.0|||repeated measures analysis|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||0.00|-0.97|0.048
72428279|NCT03954158|144367484|OTHER||Least squares mean of difference|-0.1|STANDARD_ERROR_OF_MEAN|0.39|||TWO_SIDED|95.0|-0.9|0.7||||||Change at Day 2, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.||0.7|-0.9|
72428280|NCT03954158|144367484|OTHER||Least squares mean of difference|0.2|STANDARD_ERROR_OF_MEAN|0.36|||TWO_SIDED|95.0|-0.6|1.0||||||Change at Day 2, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.||1.0|-0.6|
72428281|NCT03954158|144367484|OTHER||Difference of least squares mean|0.2|STANDARD_ERROR_OF_MEAN|0.5|||TWO_SIDED|95.0|-0.8|1.2||||||Change at Day 2, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen day dosing regimen-by-day interaction and baseline value and the covariance structure UN was used.||1.2|-0.8|
72428282|NCT03954158|144367484|OTHER||Least squares mean of difference|-0.2|STANDARD_ERROR_OF_MEAN|0.33|||TWO_SIDED|95.0|-0.9|0.5||||||Change at Day 3, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.||0.5|-0.9|
72428283|NCT03954158|144367484|OTHER||Least squares mean of difference|-0.3|STANDARD_ERROR_OF_MEAN|0.58|||TWO_SIDED|95.0|-1.5|1.0||||||Change at Day 3, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.||1.0|-1.5|
72428284|NCT03954158|144367484|OTHER||Difference of least squares mean|-0.6|STANDARD_ERROR_OF_MEAN|0.53|||TWO_SIDED|95.0|-1.6|0.5||||||Change at Day 3, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen day dosing regimen-by-day interaction and baseline value and the covariance structure UN was used.||0.5|-1.6|
72428285|NCT03954158|144367484|OTHER||Least squares mean of difference|-0.2|STANDARD_ERROR_OF_MEAN|0.45|||TWO_SIDED|95.0|-1.1|0.8||||||Change at Day 4, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.||0.8|-1.1|
72428286|NCT03954158|144367484|OTHER||Least squares mean of difference|-0.2|STANDARD_ERROR_OF_MEAN|0.62|||TWO_SIDED|95.0|-1.5|1.1||||||Change at Day 4, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.||1.1|-1.5|
72428287|NCT03954158|144367484|OTHER||Difference of least squares mean|-0.9|STANDARD_ERROR_OF_MEAN|0.74|||TWO_SIDED|95.0|-2.4|0.6||||||Change at Day 4, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen day dosing regimen-by-day interaction and baseline value and the covariance structure UN was used.||0.6|-2.4|
72428288|NCT03954158|144367484|OTHER||Least squares mean of difference|-1.4|STANDARD_ERROR_OF_MEAN|0.39|||TWO_SIDED|95.0|-2.2|-0.5||||||Change at Day 5, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.||-0.5|-2.2|
72338749|NCT00394901|144201288|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.99|||<|0.001||95.0|-1.47|-0.52|||repeated measures analysis|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.52|-1.47|<0.001
72428289|NCT03954158|144367484|OTHER||Least squares mean of difference|0.1|STANDARD_ERROR_OF_MEAN|0.66|||TWO_SIDED|95.0|-1.3|1.5||||||Change at Day 5, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.||1.5|-1.3|
72428290|NCT03954158|144367484|OTHER||Difference of least squares mean|-0.2|STANDARD_ERROR_OF_MEAN|0.7|||TWO_SIDED|95.0|-1.7|1.2||||||Change at Day 5, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen day dosing regimen-by-day interaction and baseline value and the covariance structure UN was used.||1.2|-1.7|
72428291|NCT03954158|144367484|OTHER||Least squares mean of difference|-1.0|STANDARD_ERROR_OF_MEAN|0.46|||TWO_SIDED|95.0|-2.0|0.0||||||Change at Day 6, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.||0.0|-2.0|
72428292|NCT03954158|144367484|OTHER||Least squares mean of difference|-0.5|STANDARD_ERROR_OF_MEAN|0.47|||TWO_SIDED|95.0|-1.4|0.5||||||Change at Day 6, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.||0.5|-1.4|
72338750|NCT00394901|144201288|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.03|||<|0.001||95.0|-1.49|-0.56|||repeated measures analysis|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.56|-1.49|<0.001
72338751|NCT00394901|144201289|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.41||||0.096||95.0|-0.89|0.07|||repeated measures analysis|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||0.07|-0.89|0.096
72428293|NCT03954158|144367484|OTHER||Difference of least squares mean|-0.4|STANDARD_ERROR_OF_MEAN|0.63|||TWO_SIDED|95.0|-1.7|0.8||||||Change at Day 6, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen day dosing regimen-by-day interaction and baseline value and the covariance structure UN was used.||0.8|-1.7|
72428294|NCT03954158|144367484|OTHER||Least squares mean of difference|-1.1|STANDARD_ERROR_OF_MEAN|0.42|||TWO_SIDED|95.0|-2.0|-0.2||||||Change at Day 7, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.||-0.2|-2.0|
72428295|NCT03954158|144367484|OTHER||Least squares mean of difference|-1.1|STANDARD_ERROR_OF_MEAN|0.48|||TWO_SIDED|95.0|-2.1|-0.1||||||Change at Day 7, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.||-0.1|-2.1|
72428296|NCT03954158|144367484|OTHER||Difference of least squares mean|-0.6|STANDARD_ERROR_OF_MEAN|0.61|||TWO_SIDED|95.0|-1.9|0.6||||||Change at Day 7, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen day dosing regimen-by-day interaction and baseline value and the covariance structure UN was used.||0.6|-1.9|
72428297|NCT03954158|144367484|OTHER||Least squares mean of difference|-1.0|STANDARD_ERROR_OF_MEAN|0.49|||TWO_SIDED|95.0|-2.0|0.0||||||Change at Day 8, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.||0.0|-2.0|
72428298|NCT03954158|144367484|OTHER||Least squares mean of difference|-1.3|STANDARD_ERROR_OF_MEAN|0.52|||TWO_SIDED|95.0|-2.4|-0.2||||||Change at Day 8, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.||-0.2|-2.4|
72338752|NCT00394901|144201289|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.96|||<|0.001||95.0|-1.44|-0.48|||repeated measures analysis|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.48|-1.44|<0.001
72338753|NCT00394901|144201289|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.99|||<|0.001||95.0|-1.46|-0.52|||repeated measures analysis|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.52|-1.46|<0.001
72338754|NCT00394901|144201290|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.55||||0.505||95.0|-2.16|1.06|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||1.06|-2.16|0.505
72338755|NCT00394901|144201290|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.86||||0.023||95.0|-3.46|-0.26|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.26|-3.46|0.023
72338756|NCT00394901|144201290|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.0||||0.012||95.0|-3.56|-0.44|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.44|-3.56|0.012
72338757|NCT00394901|144201291|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.29||||0.349||95.0|-0.91|0.32|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||0.32|-0.91|0.349
72338758|NCT00394901|144201291|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.71||||0.024||95.0|-1.32|-0.1|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.10|-1.32|0.024
72338759|NCT00394901|144201291|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.61||||0.045||95.0|-1.21|-0.01|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.01|-1.21|0.045
72338760|NCT00394901|144201292|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.83||||0.441||95.0|-2.93|1.28|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||1.28|-2.93|0.441
72338761|NCT00394901|144201292|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.55||||0.017||95.0|-4.64|-0.46|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.46|-4.64|0.017
72338762|NCT00394901|144201292|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.61||||0.012||95.0|-4.65|-0.56|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.56|-4.65|0.012
72338763|NCT00394901|144201293|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.23||||0.47||95.0|-8.28|3.83|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||3.83|-8.28|0.470
72338764|NCT00394901|144201293|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-8.04||||0.008||95.0|-14.0|-2.06|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-2.06|-14.0|0.008
72338765|NCT00394901|144201293|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-7.43||||0.013||95.0|-13.3|-1.59|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-1.59|-13.3|0.013
72338766|NCT00394901|144201294|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.2||||0.178||95.0|-0.48|0.09|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||0.09|-0.48|0.178
72338767|NCT00394901|144201294|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.43||||0.003||95.0|-0.72|-0.15|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.15|-0.72|0.003
72338768|NCT00394901|144201294|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.31||||0.03||95.0|-0.59|-0.03|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.03|-0.59|0.030
72338769|NCT00394901|144201295|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.76||||0.001||95.0|-1.23|-0.3|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.30|-1.23|0.001
72338770|NCT00394901|144201295|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.81||||0.001||95.0|-1.27|-0.34|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.34|-1.27|0.001
72338771|NCT00394901|144201295|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.94|||<|0.001||95.0|-1.4|-0.49|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.49|-1.40|<0.001
72338772|NCT00394901|144201296|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-8.9||||0.001||95.0|-14.2|-3.61|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-3.61|-14.2|0.001
72338773|NCT00394901|144201296|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-8.24||||0.002||95.0|-13.5|-2.99|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-2.99|-13.5|0.002
72338774|NCT00394901|144201296|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-11.3|||<|0.001||95.0|-16.5|-6.22|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-6.22|-16.5|<0.001
72338775|NCT00394901|144201297|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.29||||0.245||95.0|-2.95|11.54|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||11.54|-2.95|0.245
72338776|NCT00394901|144201297|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.95||||0.417||95.0|-4.2|10.11|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||10.11|-4.20|0.417
72338777|NCT00394901|144201297|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|9.7||||0.007||95.0|2.67|16.74|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||16.74|2.67|0.007
72338778|NCT00394901|144201298|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.71||||0.76||95.0|-3.83|5.24|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||5.24|-3.83|0.760
72338779|NCT00394901|144201298|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.71||||0.754||95.0|-3.75|5.18|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||5.18|-3.75|0.754
72338780|NCT00394901|144201298|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.04||||0.641||95.0|-5.43|3.35|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||3.35|-5.43|0.641
72338781|NCT00394901|144201299|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.01||||0.955||95.0|-0.3|0.32|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||0.32|-0.30|0.955
72338782|NCT00394901|144201299|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.27||||0.084||95.0|-0.04|0.58|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||0.58|-0.04|0.084
72428299|NCT03954158|144367484|OTHER||Difference of least squares mean|-0.6|STANDARD_ERROR_OF_MEAN|0.64|||TWO_SIDED|95.0|-1.9|0.7||||||Change at Day 8, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen day dosing regimen-by-day interaction and baseline value and the covariance structure UN was used.||0.7|-1.9|
72338783|NCT00394901|144201299|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.21||||0.17||95.0|-0.09|0.52|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||0.52|-0.09|0.170
72338784|NCT00394901|144201300|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.01||||0.296||95.0|-3.52|11.55|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||11.55|-3.52|0.296
72338785|NCT00394901|144201300|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|10.3||||0.007||95.0|2.87|17.73|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||17.73|2.87|0.007
72428300|NCT03954158|144367484|OTHER||Least squares mean of difference|-1.2|STANDARD_ERROR_OF_MEAN|0.54|||TWO_SIDED|95.0|-2.3|-0.1||||||Change at Day 9, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.||-0.1|-2.3|
72428301|NCT03954158|144367484|OTHER||Least squares mean of difference|-0.9|STANDARD_ERROR_OF_MEAN|0.49|||TWO_SIDED|95.0|-1.9|0.1||||||Change at Day 9, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.||0.1|-1.9|
72338786|NCT00394901|144201300|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|6.0||||0.106||95.0|-1.29|13.3|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||13.30|-1.29|0.106
72338787|NCT00394901|144201301|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.93||||0.191||95.0|-1.97|9.83|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||9.83|-1.97|0.191
72338788|NCT00394901|144201301|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|11.21|||<|0.001||95.0|5.41|17.02|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||17.02|5.41|<0.001
72338789|NCT00394901|144201301|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|14.23|||<|0.001||95.0|8.5|19.95|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||19.95|8.50|<0.001
72338790|NCT00394901|144201302|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.03||||0.061||95.0|-8.25|0.18|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||0.18|-8.25|0.061
72338791|NCT00394901|144201302|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.2||||0.133||95.0|-7.37|0.98|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||0.98|-7.37|0.133
72338792|NCT00394901|144201302|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.44||||0.24||95.0|-6.52|1.64|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||1.64|-6.52|0.240
72338793|NCT00394901|144201303|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.68||||0.2842||95.0|0.34|1.37|||Regression, Logistic|treatment, CLcr stratum, and the optimal sleep score at baseline as covariate||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||1.37|0.34|0.2842
72338794|NCT00394901|144201303|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.89||||0.0577||95.0|0.98|3.66|||Regression, Logistic|treatment, CLcr stratum, and the optimal sleep score at baseline as covariate||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||3.66|0.98|0.0577
72338795|NCT00394901|144201303|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.54||||0.1893||95.0|0.81|2.95|||Regression, Logistic|treatment, CLcr stratum, and the optimal sleep score at baseline as covariate||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||2.95|0.81|0.1893
72338796|NCT00394901|144201304|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0466||95.0|||||Cochran-Mantel-Haenszel|stratified by CLcr stratum||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||||0.0466
72338797|NCT00394901|144201304|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel|stratified by CLcr stratum||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||||<0.001
72338798|NCT00394901|144201304|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel|stratified by CLcr stratum||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||||<0.001
72338799|NCT00394901|144201305|SUPERIORITY_OR_OTHER_LEGACY|||||||0.344||95.0|||||Cochran-Mantel-Haenszel|stratified by CLcr stratum||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||||0.3440
72338800|NCT00394901|144201305|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel|stratified by CLcr stratum||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||||<0.001
72338801|NCT00394901|144201305|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel|stratified by CLcr stratum||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||||<0.001
72338802|NCT00394901|144201306|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.51||||0.057||95.0|-0.1|7.13|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||7.13|-0.10|0.057
72338803|NCT00394901|144201306|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.77||||0.67||95.0|-2.78|4.32|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||4.32|-2.78|0.670
72338804|NCT00394901|144201306|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.04||||0.559||95.0|-2.45|4.53|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||4.53|-2.45|0.559
72338805|NCT00394901|144201307|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|9.4||||0.004||95.0|3.01|15.78|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||15.78|3.01|0.004
72338806|NCT00394901|144201307|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|6.67||||0.037||95.0|0.39|12.95|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||12.95|0.39|0.037
72338807|NCT00394901|144201307|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.46||||0.643||95.0|-4.74|7.66|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||7.66|-4.74|0.643
72338808|NCT00394901|144201308|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.62||||0.811||95.0|-4.5|5.75|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||5.75|-4.50|0.811
72338809|NCT00394901|144201308|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|7.07||||0.006||95.0|2.03|12.12|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||12.12|2.03|0.006
72338810|NCT00394901|144201308|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.03||||0.047||95.0|0.06|10.0|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||10.00|0.06|0.047
72338811|NCT00394901|144201309|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.3||||0.013||95.0|1.1|9.5|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||9.50|1.10|0.013
72338812|NCT00394901|144201309|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.82||||0.07||95.0|-0.31|7.96|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||7.96|-0.31|0.070
72338813|NCT00394901|144201309|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.93||||0.058||95.0|-0.13|8.0|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||8.00|-0.13|0.058
72338814|NCT00394901|144201310|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.43||||0.443||95.0|-3.79|8.65|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||8.65|-3.79|0.443
72338815|NCT00394901|144201310|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|7.41||||0.018||95.0|1.28|13.54|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||13.54|1.28|0.018
72338816|NCT00394901|144201310|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.83||||0.549||95.0|-4.18|7.85|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||7.85|-4.18|0.549
72338817|NCT00394901|144201311|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|6.15||||0.075||95.0|-0.63|12.92|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||12.92|-0.63|0.075
72338818|NCT00394901|144201311|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.41||||0.111||95.0|-1.25|12.08|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||12.08|-1.25|0.111
72428302|NCT03954158|144367484|OTHER||Difference of least squares mean|-1.1|STANDARD_ERROR_OF_MEAN|0.63|||TWO_SIDED|95.0|-2.4|0.2||||||Change at Day 9, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen day dosing regimen-by-day interaction and baseline value and the covariance structure UN was used.||0.2|-2.4|
72428303|NCT03954158|144367484|OTHER||Least squares mean of difference|-1.3|STANDARD_ERROR_OF_MEAN|0.54|||TWO_SIDED|95.0|-2.4|-0.1||||||Change at Day 10, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.||-0.1|-2.4|
72428304|NCT03954158|144367484|OTHER||Least squares mean of difference|-1.6|STANDARD_ERROR_OF_MEAN|0.45|||TWO_SIDED|95.0|-2.5|-0.7||||||Change at Day 10, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.||-0.7|-2.5|
72428305|NCT03954158|144367484|OTHER||Difference of least squares mean|-1.4|STANDARD_ERROR_OF_MEAN|0.58|||TWO_SIDED|95.0|-2.6|-0.2||||||Change at Day 10, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen day dosing regimen-by-day interaction and baseline value and the covariance structure UN was used.||-0.2|-2.6|
72428306|NCT03954158|144367484|OTHER||Least squares mean of difference|-1.3|STANDARD_ERROR_OF_MEAN|0.54|||TWO_SIDED|95.0|-2.4|-0.1||||||Change at Day 11, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.||-0.1|-2.4|
72428307|NCT03954158|144367484|OTHER||Least squares mean of difference|-1.2|STANDARD_ERROR_OF_MEAN|0.51|||TWO_SIDED|95.0|-2.2|-0.1||||||Change at Day 11, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.||-0.1|-2.2|
72428308|NCT03954158|144367484|OTHER||Difference of least squares mean|-0.8|STANDARD_ERROR_OF_MEAN|0.67|||TWO_SIDED|95.0|-2.2|0.5||||||Change at Day 11, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen day dosing regimen-by-day interaction and baseline value and the covariance structure UN was used.||0.5|-2.2|
72428309|NCT03954158|144367484|OTHER||Least squares mean of difference|-1.5|STANDARD_ERROR_OF_MEAN|0.7|||TWO_SIDED|95.0|-2.9|0.0||||||Change at Day 12, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.||0.0|-2.9|
72428310|NCT03954158|144367484|OTHER||Least squares mean of difference|-1.6|STANDARD_ERROR_OF_MEAN|0.4|||TWO_SIDED|95.0|-2.4|-0.7||||||Change at Day 12, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.||-0.7|-2.4|
72338819|NCT00394901|144201311|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.02||||0.366||95.0|-3.55|9.6|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||9.60|-3.55|0.366
72428311|NCT03954158|144367484|OTHER||Difference of least squares mean|-1.6|STANDARD_ERROR_OF_MEAN|0.63|||TWO_SIDED|95.0|-2.9|-0.3||||||Change at Day 12, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen day dosing regimen-by-day interaction and baseline value and the covariance structure UN was used.||-0.3|-2.9|
72428312|NCT03954158|144367484|OTHER||Least squares mean of difference|-1.1|STANDARD_ERROR_OF_MEAN|0.68|||TWO_SIDED|95.0|-2.5|0.3||||||Change at Day 13, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.||0.3|-2.5|
72428313|NCT03954158|144367484|OTHER||Least squares mean of difference|-1.5|STANDARD_ERROR_OF_MEAN|0.44|||TWO_SIDED|95.0|-2.4|-0.6||||||Change at Day 13, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.||-0.6|-2.4|
72428314|NCT03954158|144367484|OTHER||Difference of least squares mean|-1.7|STANDARD_ERROR_OF_MEAN|0.62|||TWO_SIDED|95.0|-3.0|-0.5||||||Change at Day 13, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen day dosing regimen-by-day interaction and baseline value and the covariance structure UN was used.||-0.5|-3.0|
72338820|NCT00394901|144201312|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.64||||0.039||95.0|0.29|11.0|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||11.00|0.29|0.039
72338821|NCT00394901|144201312|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|7.42||||0.006||95.0|2.14|12.69|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||12.69|2.14|0.006
72338822|NCT00394901|144201312|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.15||||0.117||95.0|-1.05|9.34|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||9.34|-1.05|0.117
72338823|NCT00394901|144201313|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.99||||0.154||95.0|-1.5|9.49|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05||9.49|-1.50|0.154
72338824|NCT00394901|144201313|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|6.99||||0.012||95.0|1.58|12.4|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||12.40|1.58|0.012
72428315|NCT03954158|144367484|OTHER||Least squares mean of difference|-1.6|STANDARD_ERROR_OF_MEAN|0.45|||TWO_SIDED|95.0|-2.5|-0.6||||||Change at Day 14, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.||-0.6|-2.5|
72428316|NCT03954158|144367484|OTHER||Difference of least squares mean|-1.6|STANDARD_ERROR_OF_MEAN|0.59|||TWO_SIDED|95.0|-2.8|-0.4||||||Change at Day 14, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen day dosing regimen-by-day interaction and baseline value and the covariance structure UN was used.||-0.4|-2.8|
72338825|NCT00394901|144201313|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.76||||0.079||95.0|-0.56|10.08|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||10.08|-0.56|0.079
72338826|NCT00394901|144201314|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.28||||0.6451||95.0|0.45|3.59|||Regression, Logistic|treatment, CLcr stratum, and the presence of symptom at baseline as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||3.59|0.45|0.6451
72338827|NCT00394901|144201314|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.56||||0.0745||95.0|0.91|7.19|||Regression, Logistic|treatment, CLcr stratum, and the presence of symptom at baseline as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||7.19|0.91|0.0745
72338828|NCT00394901|144201314|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.01||||0.1787||95.0|0.73|5.58|||Regression, Logistic|treatment, CLcr stratum, and the presence of symptom at baseline as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||5.58|0.73|0.1787
72338829|NCT00394901|144201315|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.26||||0.0732||95.0|0.93|5.52|||Regression, Logistic|treatment, CLcr stratum, and the presence of symptom at baseline as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||5.52|0.93|0.0732
72338830|NCT00394901|144201315|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.64||||0.0353||95.0|1.07|6.53|||Regression, Logistic|treatment, CLcr stratum, and the presence of symptom at baseline as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||6.53|1.07|0.0353
72338831|NCT00394901|144201315|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.5||||0.0393||95.0|1.05|5.96|||Regression, Logistic|treatment, CLcr stratum, and the presence of symptom at baseline as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||5.96|1.05|0.0393
72338832|NCT00394901|144201316|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.3||||0.227||95.0|-0.78|0.18|||repeated measures analysis|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||0.18|-0.78|0.227
72338833|NCT00394901|144201316|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.86|||<|0.001||95.0|-1.34|-0.38|||repeated measures analysis|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.38|-1.34|<0.001
72428317|NCT03954158|144367484|OTHER||Least squares mean of difference|-1.2|STANDARD_ERROR_OF_MEAN|0.62|||TWO_SIDED|95.0|-2.5|0.1||||||Change at Day 14, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.||0.1|-2.5|
72338834|NCT00394901|144201316|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.93|||<|0.001||95.0|-1.4|-0.46|||repeated measures analysis|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.46|-1.40|<0.001
72338835|NCT00394901|144201317|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.14||||0.577||95.0|-0.62|0.35|||repeated measures analysis|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||0.35|-0.62|0.577
72338836|NCT00394901|144201317|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-0.87|||<|0.001||95.0|-1.35|-0.39|||repeated measures analysis|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.39|-1.35|<0.001
72338837|NCT00394901|144201317|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.74||||0.002||95.0|-1.22|-0.27|||repeated measures analysis|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.27|-1.22|0.002
72428318|NCT03954158|144367484|OTHER||Least squares mean of difference|-1.3|STANDARD_ERROR_OF_MEAN|0.57|||TWO_SIDED|95.0|-2.4|-0.1||||||Change at Day 15, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.||-0.1|-2.4|
72338838|NCT00394901|144201318|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.27||||0.275||95.0|-0.75|0.21|||repeated measures analysis|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||0.21|-0.75|0.275
72338839|NCT00394901|144201318|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.98|||<|0.001||95.0|-1.46|-0.5|||repeated measures analysis|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.50|-1.46|<0.001
72338840|NCT00394901|144201318|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.75||||0.002||95.0|-1.22|-0.28|||repeated measures analysis|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.28|-1.22|0.002
72338841|NCT00394901|144201319|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.24||||0.334||95.0|-0.72|0.25|||repeated measures analysis|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||0.25|-0.72|0.334
72338842|NCT00394901|144201319|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.9|||<|0.001||95.0|-1.38|-0.42|||repeated measures analysis|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.42|-1.38|<0.001
72338843|NCT00394901|144201319|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.66||||0.006||95.0|-1.14|-0.19|||repeated measures analysis|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.19|-1.14|0.006
72428319|NCT03954158|144367484|OTHER||Least squares mean of difference|-1.3|STANDARD_ERROR_OF_MEAN|0.46|||TWO_SIDED|95.0|-2.2|-0.3||||||Change at Day 15, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.||-0.3|-2.2|
72338844|NCT00394901|144201320|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.15||||0.53||95.0|-0.64|0.33|||repeated measures analysis|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||0.33|-0.64|0.530
72338845|NCT00394901|144201320|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.82||||0.001||95.0|-1.3|-0.33|||repeated measures analysis|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.33|-1.30|0.001
72338846|NCT00394901|144201320|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.58||||0.017||95.0|-1.05|-0.1|||repeated measures analysis|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.10|-1.05|0.017
72338847|NCT00394901|144201321|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.21||||0.392||95.0|-0.7|0.27|||repeated measures analysis|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||0.27|-0.70|0.392
72338848|NCT00394901|144201321|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.87|||<|0.001||95.0|-1.35|-0.38|||repeated measures analysis|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.38|-1.35|<0.001
72338849|NCT00394901|144201321|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.58||||0.016||95.0|-1.06|-0.11|||repeated measures analysis|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.11|-1.06|0.016
72338850|NCT00394901|144201322|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.22||||0.364||95.0|-0.71|0.26|||repeated measures analysis|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||0.26|-0.71|0.364
72338851|NCT00394901|144201322|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.91|||<|0.001||95.0|-1.39|-0.42|||repeated measures analysis|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.42|-1.39|<0.001
72338852|NCT00394901|144201322|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.52||||0.031||95.0|-1.0|-0.05|||repeated measures analysis|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.05|-1.00|0.031
72338853|NCT00394901|144201323|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.24||||0.326||95.0|-0.73|0.24|||repeated measures analysis|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||0.24|-0.73|0.326
72338854|NCT00394901|144201323|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.94|||<|0.001||95.0|-1.43|-0.46|||repeated measures analysis|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.46|-1.43|<0.001
72338855|NCT00394901|144201323|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.65||||0.007||95.0|-1.13|-0.18|||repeated measures analysis|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.18|-1.13|0.007
72338856|NCT00394901|144201324|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.29||||0.241||95.0|-0.78|0.2|||repeated measures analysis|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||0.20|-0.78|0.241
72338857|NCT00394901|144201324|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.85||||0.001||95.0|-1.34|-0.37|||repeated measures analysis|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.37|-1.34|0.001
72338858|NCT00394901|144201324|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.63||||0.01||95.0|-1.1|-0.15|||repeated measures analysis|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.15|-1.10|0.010
72338859|NCT00394901|144201325|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.27||||0.281||95.0|-0.76|0.22|||repeated measures analysis|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||0.22|-0.76|0.281
72338860|NCT00394901|144201325|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.82||||0.001||95.0|-1.3|-0.33|||repeated measures analysis|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.33|-1.30|0.001
72338861|NCT00394901|144201325|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.62||||0.012||95.0|-1.09|-0.14|||repeated measures analysis|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.14|-1.09|0.012
72338862|NCT05028517|144201339|SUPERIORITY||ANOVA Omnibus F test|0.511||||0.602|TWO_SIDED||||||ANOVA|||||||.602
72338863|NCT05028517|144201340|SUPERIORITY||ANOVA Omnibus F test|1.245||||0.294|TWO_SIDED||||||ANOVA|||||||.294
72338864|NCT05028517|144201341|SUPERIORITY||Anova Omnibus F test|2.585||||0.039|TWO_SIDED||||||ANOVA|||||||.039
72338865|NCT05028517|144201342|SUPERIORITY||Anova Omnibus F test|2.723||||0.032|TWO_SIDED||||||ANOVA|||||||0.032
72338866|NCT05028517|144201343|SUPERIORITY||Anova Omnibus F test|0.588||||0.672|TWO_SIDED||||||ANOVA|||||||0.672
72338867|NCT05028517|144201344|SUPERIORITY||Anova Omnibus F test|2.612||||0.038|TWO_SIDED||||||ANOVA|||||||0.038
72338868|NCT05028517|144201345|SUPERIORITY||Anova Omnibus F test|0.196||||0.94|TWO_SIDED||||||ANOVA|||||||.940
72338869|NCT05028517|144201346|SUPERIORITY||Anova Omnibus F test|0.59||||0.671|TWO_SIDED||||||ANOVA|||||||.671
72338870|NCT05028517|144201347|SUPERIORITY||Anova Omnibus F test|0.896||||0.468|TWO_SIDED||||||ANOVA|||||||.468
72338871|NCT05028517|144201348|SUPERIORITY||Anova Omnibus F test|3.42||||0.01|TWO_SIDED||||||ANOVA|||||||0.01
72338872|NCT05028517|144201349|SUPERIORITY||Anova Omnibus F test|1.384||||0.257|TWO_SIDED||||||ANOVA|||||||.257
72338873|NCT05028517|144201350|SUPERIORITY||Anova Omnibus F test|1.686||||0.192|TWO_SIDED||||||ANOVA|||||||.192
72338874|NCT05028517|144201351|SUPERIORITY||Anova Omnibus F test|0.651||||0.524|TWO_SIDED||||||ANOVA|||||||.524
72338875|NCT05028517|144201352|SUPERIORITY||Anova Omnibus F test|1.32||||0.255|TWO_SIDED||||||ANOVA|||||||.255
72338876|NCT02360293|144201360|SUPERIORITY||Slope|1.88|STANDARD_ERROR_OF_MEAN|46.2|||TWO_SIDED|95.0|-119.0|122.7|||||Generated through ANCOVA predicting Active Minutes as a function of arm and f/u time, adjusted for Sex, Baseline PA Goal (AM), and type of Smart Phone. Represents the contrast between SS+Coaching, 12 mos. - Baseline vs. SS alone, 12 mos. - Baseline.|Estimated marginal means/least squares means are derived from a linear mixed model/rmANOVA/rmANCOVA, adjusted for baseline AM goal, Type of Smart Phone, and Sex.||122.7|-119.0|
72338877|NCT02360293|144201361|SUPERIORITY||Slope|-5.02|STANDARD_ERROR_OF_MEAN|56.7|||TWO_SIDED|95.0|-15.85|5.81|||||Generated through ANCOVA predicting Weight as a function of the interaction of arm and follow-up time. Estimate represents the contrast between SS+Coaching, 12 mos. - Baseline vs. SS alone, 12 mos. - Baseline.|The estimated marginal means/least squares means are derived from a linear mixed model/rmANOVA/rmANCOVA.||5.81|-15.85|
72338878|NCT02360293|144201362|SUPERIORITY||Slope|-1.162|STANDARD_ERROR_OF_MEAN|0.69|||TWO_SIDED|95.0|-2.969|0.646|||||Generated through ANCOVA predicting PHQ-8 Score as a function of the interaction of arm and follow-up time. Estimate represents the contrast between SS+Coaching, 12 mos. - Baseline vs. SS alone, 12 mos. - Baseline.|The estimated marginal means/least squares means are derived from a linear mixed model/rmANOVA/rmANCOVA.||0.646|-2.969|
72338879|NCT02360293|144201363|SUPERIORITY||Slope|-0.345|STANDARD_ERROR_OF_MEAN|0.267|||TWO_SIDED|95.0|-1.044|0.353|||||"Estimate generated through ANCOVA predicting Pain In Past Week as a function of the interaction of arm and follow-up time. Estimate represents the contrast between SS+Coaching, 12 mos. - Baseline vs. SS alone, 12 mos. - Baseline.."|The estimated marginal means/least squares means are derived from a linear mixed model/rmANOVA/rmANCOVA.||0.353|-1.044|
72338880|NCT02725593|144201371|SUPERIORITY||Mean Difference (Final Values)|-0.75|STANDARD_ERROR_OF_MEAN|0.45||0.101|TWO_SIDED|95.0|-1.65|0.15|||Mixed model repeated measures analysis|||||0.15|-1.65|0.101
72428320|NCT03954158|144367484|OTHER||Difference of least squares mean|-1.4|STANDARD_ERROR_OF_MEAN|0.66|||TWO_SIDED|95.0|-2.8|-0.1||||||Change at Day 15, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen day dosing regimen-by-day interaction and baseline value and the covariance structure UN was used.||-0.1|-2.8|
72338881|NCT02725593|144201372|SUPERIORITY||Mean Difference (Final Values)|-0.78|STANDARD_ERROR_OF_MEAN|0.81||0.34|TWO_SIDED|95.0|-2.42|0.85|||Mixed model repeated measures analysis|||||0.85|-2.42|0.340
72338882|NCT02725593|144201373|SUPERIORITY||Mean Difference (Final Values)|-3.96||||0.655|TWO_SIDED|95.0|-20.11|9.62|||Fisher's exact test|||||9.62|-20.11|0.655
72338883|NCT02725593|144201374|SUPERIORITY||Mean Difference (Final Values)|20.83||||0.056|TWO_SIDED|95.0|0.5|41.11|||Fisher's exact test|||||41.11|0.50|0.056
72338884|NCT04411420|144201377|SUPERIORITY||Mean Difference (Final Values)|-0.59||||0.169|TWO_SIDED|97.5|-1.55|0.37||Threshold for significance is 0.025 due to dual primary outcomes.|Mixed Models Analysis|Hierarchical linear model fit included random effects for clinic and clinic by time and pre-specified clinic- and patient-level covariates.|Difference is calculated as Integrated Sequenced Care Pathway 3-month change minus Coordinated Care Management Pathway 3-month change.|||0.37|-1.55|0.169
72338885|NCT04411420|144201378|SUPERIORITY||Mean Difference (Final Values)|0.59||||0.139|TWO_SIDED|97.5|-0.33|1.52||Threshold for significance is 0.025 due to dual primary outcomes.|Mixed Models Analysis|Hierarchical linear model fit included random effects for clinic and clinic by time and pre-specified clinic- and patient-level covariates.|Difference is calculated as Integrated Sequenced Care Pathway 3-month change minus Coordinated Care Management Pathway 3-month change.|||1.52|-0.33|0.139
72428321|NCT02080520|144367493|SUPERIORITY|||||||0.31|||||||Mixed Models Analysis|||||||0.31
72338886|NCT04411420|144201379|SUPERIORITY||Mean Difference (Final Values)|-0.48||||0.417|TWO_SIDED|95.0|-1.69|0.72||P-value is not adjusted for multiple comparisons. Threshold for significance is 0.05.|Mixed Models Analysis|Hierarchical linear model fit included random effects for clinic and clinic by time and pre-specified clinic- and patient-level covariates.||||0.72|-1.69|0.417
72338887|NCT04411420|144201380|SUPERIORITY||Mean Difference (Final Values)|-0.4||||0.409|TWO_SIDED|95.0|-1.37|0.57||P-values are not adjusted for multiple comparisons. Threshold for significance is 0.05.|Mixed Models Analysis|Hierarchical linear model fit included random effects for clinic and clinic by time and pre-specified clinic- and patient-level covariates.|Difference is calculated as Integrated Sequenced Care Pathway change minus Coordinated Care Management Pathway change.|Baseline to 3 months||0.57|-1.37|0.409
72338888|NCT04411420|144201380|SUPERIORITY||Mean Difference (Final Values)|-0.06||||0.899|TWO_SIDED|95.0|-1.04|0.91||P-values are not adjusted for multiple comparisons. Threshold for significance is 0.05.|Mixed Models Analysis|Hierarchical linear model fit included random effects for clinic and clinic by time and pre-specified clinic- and patient-level covariates.|Difference is calculated as Integrated Sequenced Care Pathway change minus Coordinated Care Management Pathway change.|Baseline to 6 months||0.91|-1.04|0.899
72338889|NCT04411420|144201380|SUPERIORITY||Mean Difference (Final Values)|0.04||||0.946|TWO_SIDED|95.0|-1.01|1.08||P-values are not adjusted for multiple comparisons. Threshold for significance is 0.05.|Mixed Models Analysis|Hierarchical linear model fit included random effects for clinic and clinic by time and pre-specified clinic- and patient-level covariates.|Difference is calculated as Integrated Sequenced Care Pathway change minus Coordinated Care Management Pathway change.|Baseline to 12 months||1.08|-1.01|0.946
72338890|NCT04411420|144201381|SUPERIORITY||Odds Ratio, log|-0.004||||0.992|TWO_SIDED|95.0|-4.62|4.61||P-value is not adjusted for multiple comparisons. Threshold for significance is 0.05.|Regression, Logistic|Hierarchical linear model fit included random effects for clinic and clinic by time and pre-specified clinic- and patient-level covariates.|Odds Ratio calculated for Integrated Sequenced Care Pathway relative to Coordinated Care Management Pathway.|||4.61|-4.62|0.992
72428322|NCT02080520|144367494|SUPERIORITY|||||||0.52|||||||Mixed Models Analysis|||||||0.52
72428323|NCT02080520|144367495|SUPERIORITY|||||||0.32|||||||Mixed Models Analysis|||||||0.32
72428324|NCT00579982|144367525|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Paired t-test|t-test, 2 sided|||||||<0.001
72338891|NCT04411420|144201382|SUPERIORITY||Median Difference (Final Values)|-2.67||||0.262|TWO_SIDED|95.0|-7.52|2.18||P-value is not adjusted for multiple comparisons. Threshold for significance is 0.05.|Mixed Models Analysis|Hierarchical linear model fit included random effects for clinic and clinic by time and pre-specified clinic- and patient-level covariates.|Difference is calculated as Integrated Sequenced Care Pathway change minus Coordinated Care Management Pathway change.|||2.18|-7.52|0.262
72338892|NCT04411420|144201383|SUPERIORITY||Mean Difference (Final Values)|-0.4||||0.37|TWO_SIDED|97.5|-1.31|0.5||Threshold for significance is 0.025 due to dual primary outcomes.|Mixed Models Analysis|Hierarchical linear model fit included random effects for clinic and clinic by time and pre-specified clinic- and patient-level covariates.|Difference is calculated as Integrated Sequenced Care Pathway change minus Coordinated Care Management Pathway change.|Baseline to 3 months||0.50|-1.31|0.37
72338893|NCT04411420|144201383|SUPERIORITY||Mean Difference (Final Values)|-0.57||||0.24|TWO_SIDED|97.5|-1.54|0.39||Threshold for significance is 0.025 due to dual primary outcomes.|Mixed Models Analysis|Hierarchical linear model fit included random effects for clinic and clinic by time and pre-specified clinic- and patient-level covariates.|Difference is calculated as Integrated Sequenced Care Pathway change minus Coordinated Care Management Pathway change.|Baseline to 6 months||0.39|-1.54|0.24
72338894|NCT04411420|144201383|SUPERIORITY||Mean Difference (Final Values)|-0.45||||0.37|TWO_SIDED|97.5|-1.43|0.54|||Mixed Models Analysis|Hierarchical linear model fit included random effects for clinic and clinic by time and pre-specified clinic- and patient-level covariates.|Difference is calculated as Integrated Sequenced Care Pathway change minus Coordinated Care Management Pathway change.|Baseline to 12 months||0.54|-1.43|0.37
72338895|NCT04411420|144201384|SUPERIORITY||Mean Difference (Final Values)|0.11||||0.727|TWO_SIDED|97.5|-0.51|0.72||Threshold for significance is 0.025 due to dual primary outcomes.|Mixed Models Analysis|Hierarchical linear model fit included random effects for clinic and clinic by time and pre-specified clinic- and patient-level covariates.|Difference is calculated as Integrated Sequenced Care Pathway change minus Coordinated Care Management Pathway change.|Baseline to 3 months||0.72|-0.51|0.727
72338896|NCT04411420|144201384|SUPERIORITY||Mean Difference (Final Values)|0.24||||0.478|TWO_SIDED|97.5|-0.43|0.91||Threshold for significance is 0.025 due to dual primary outcomes.|Mixed Models Analysis|Hierarchical linear model fit included random effects for clinic and clinic by time and pre-specified clinic- and patient-level covariates.|Difference is calculated as Integrated Sequenced Care Pathway change minus Coordinated Care Management Pathway change.|Baseline to 6 months||0.91|-0.43|0.478
72338897|NCT04411420|144201384|SUPERIORITY||Mean Difference (Final Values)|-0.05||||0.894|TWO_SIDED|97.5|-0.75|0.66||Threshold for significance is 0.025 due to dual primary outcomes.|Mixed Models Analysis|Hierarchical linear model fit included random effects for clinic and clinic by time and pre-specified clinic- and patient-level covariates.|Difference is calculated as Integrated Sequenced Care Pathway change minus Coordinated Care Management Pathway change.|Baseline to 12 months||0.66|-0.75|0.894
72338898|NCT04411420|144201385|SUPERIORITY||Mean Difference (Final Values)|-0.06||||0.222|TWO_SIDED|95.0|-0.15|0.04||P-values are not adjusted for multiple comparisons. Threshold for significance is 0.05.|Mixed Models Analysis|Hierarchical linear model fit included random effects for clinic and clinic by time and pre-specified clinic- and patient-level covariates.|Difference is calculated as Integrated Sequenced Care Pathway change minus Coordinated Care Management Pathway change.|Baseline to 3 months||0.04|-0.15|0.222
72338899|NCT04411420|144201385|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.988|TWO_SIDED|95.0|-0.1|0.09||P-values are not adjusted for multiple comparisons. Threshold for significance is 0.05.|Mixed Models Analysis|Hierarchical linear model fit included random effects for clinic and clinic by time and pre-specified clinic- and patient-level covariates.|Difference is calculated as Integrated Sequenced Care Pathway change minus Coordinated Care Management Pathway change.|Baseline to 6 months||0.09|-0.10|0.988
72338900|NCT04411420|144201385|SUPERIORITY||Mean Difference (Final Values)|-0.06||||0.269|TWO_SIDED|95.0|-0.16|0.05||P-values are not adjusted for multiple comparisons. Threshold for significance is 0.05.|Mixed Models Analysis|Hierarchical linear model fit included random effects for clinic and clinic by time and pre-specified clinic- and patient-level covariates.|Difference is calculated as Integrated Sequenced Care Pathway change minus Coordinated Care Management Pathway change.|Baseline to 12 months||0.05|-0.16|0.269
72338901|NCT04411420|144201386|SUPERIORITY||Mean Difference (Final Values)|-0.06||||0.477|TWO_SIDED|95.0|-0.22|0.1||P-values are not adjusted for multiple comparisons. Threshold for significance is 0.05.|Mixed Models Analysis|Hierarchical linear model fit included random effects for clinic and clinic by time and pre-specified clinic- and patient-level covariates.|Difference is calculated as Integrated Sequenced Care Pathway change minus Coordinated Care Management Pathway change.|Baseline to 3 months||0.10|-0.22|0.477
72338902|NCT04411420|144201386|SUPERIORITY||Mean Difference (Final Values)|-0.01||||0.877|TWO_SIDED|95.0|-0.19|0.17||P-values are not adjusted for multiple comparisons. Threshold for significance is 0.05.|Mixed Models Analysis|Hierarchical linear model fit included random effects for clinic and clinic by time and pre-specified clinic- and patient-level covariates.|Difference is calculated as Integrated Sequenced Care Pathway change minus Coordinated Care Management Pathway change.|Baseline to 6 months||0.17|-0.19|0.877
72338903|NCT04411420|144201386|SUPERIORITY||Mean Difference (Final Values)|-0.09||||0.36|TWO_SIDED|95.0|-0.29|0.11|||Mixed Models Analysis|Hierarchical linear model fit included random effects for clinic and clinic by time and pre-specified clinic- and patient-level covariates.|Difference is calculated as Integrated Sequenced Care Pathway change minus Coordinated Care Management Pathway change.|Baseline to 12 months||0.11|-0.29|0.360
72338904|NCT04411420|144201387|SUPERIORITY||Mean Difference (Final Values)|0.02||||0.858|TWO_SIDED|95.0|-0.23|0.28||P-values are not adjusted for multiple comparisons. Threshold for significance is 0.05.|Mixed Models Analysis|Hierarchical linear model fit included random effects for clinic and clinic by time and pre-specified clinic- and patient-level covariates.|Difference is calculated as Integrated Sequenced Care Pathway change minus Coordinated Care Management Pathway change.|Baseline to 3 months||0.28|-0.23|0.858
72338905|NCT04411420|144201387|SUPERIORITY||Mean Difference (Final Values)|-0.05||||0.688|TWO_SIDED|95.0|-0.32|0.21||P-values are not adjusted for multiple comparisons. Threshold for significance is 0.05.|Mixed Models Analysis|Hierarchical linear model fit included random effects for clinic and clinic by time and pre-specified clinic- and patient-level covariates.|Difference is calculated as Integrated Sequenced Care Pathway change minus Coordinated Care Management Pathway change.|Baseline to 6 months||0.21|-0.32|0.688
72338906|NCT04411420|144201387|SUPERIORITY||Mean Difference (Final Values)|-0.03||||0.833|TWO_SIDED|95.0|-0.32|0.26||P-values are not adjusted for multiple comparisons. Threshold for significance is 0.05.|Mixed Models Analysis|Hierarchical linear model fit included random effects for clinic and clinic by time and pre-specified clinic- and patient-level covariates.|Difference is calculated as Integrated Sequenced Care Pathway change minus Coordinated Care Management Pathway change.|Baseline to 12 months||0.26|-0.32|0.833
72338907|NCT04411420|144201388|SUPERIORITY||Mean Difference (Final Values)|0.23||||0.259|TWO_SIDED|95.0|-0.18|0.64||P-values are not adjusted for multiple comparisons. Threshold for significance is 0.05.|Mixed Models Analysis|Hierarchical linear model fit included random effects for clinic and clinic by time and pre-specified clinic- and patient-level covariates.|Difference is calculated as Integrated Sequenced Care Pathway change minus Coordinated Care Management Pathway change.|Baseline to 3 months||0.64|-0.18|0.259
72338908|NCT04411420|144201388|SUPERIORITY||Mean Difference (Final Values)|0.39||||0.068|TWO_SIDED|95.0|-0.03|0.81||P-values are not adjusted for multiple comparisons. Threshold for significance is 0.05.|Mixed Models Analysis|Hierarchical linear model fit included random effects for clinic and clinic by time and pre-specified clinic- and patient-level covariates.|Difference is calculated as Integrated Sequenced Care Pathway change minus Coordinated Care Management Pathway change.|Baseline to 6 months||0.81|-0.03|0.068
72338909|NCT04411420|144201388|SUPERIORITY||Mean Difference (Final Values)|0.14||||0.514|TWO_SIDED|95.0|-0.29|0.57||P-values are not adjusted for multiple comparisons. Threshold for significance is 0.05.|Mixed Models Analysis|Hierarchical linear model fit included random effects for clinic and clinic by time and pre-specified clinic- and patient-level covariates.|Difference is calculated as Integrated Sequenced Care Pathway change minus Coordinated Care Management Pathway change.|Baseline to 12 months||0.57|-0.29|0.514
72338910|NCT04411420|144201389|SUPERIORITY||Mean Difference (Final Values)|-0.01||||0.895|TWO_SIDED|95.0|-0.22|0.2||P-values are not adjusted for multiple comparisons. Threshold for significance is 0.05.|Mixed Models Analysis|Hierarchical linear model fit included random effects for clinic and clinic by time and pre-specified clinic- and patient-level covariates.|Difference is calculated as Integrated Sequenced Care Pathway change minus Coordinated Care Management Pathway change.|Baseline to 3 months||0.20|-0.22|0.895
72338911|NCT04411420|144201389|SUPERIORITY||Mean Difference (Final Values)|0.08||||0.438|TWO_SIDED|95.0|-0.13|0.3||P-values are not adjusted for multiple comparisons. Threshold for significance is 0.05.|Mixed Models Analysis|Hierarchical linear model fit included random effects for clinic and clinic by time and pre-specified clinic- and patient-level covariates.|Difference is calculated as Integrated Sequenced Care Pathway change minus Coordinated Care Management Pathway change.|Baseline to 6 months||0.30|-0.13|0.438
72338912|NCT04411420|144201389|SUPERIORITY||Mean Difference (Final Values)|-0.02||||0.89|TWO_SIDED|95.0|-0.24|0.21||P-values are not adjusted for multiple comparisons. Threshold for significance is 0.05.|Mixed Models Analysis|Hierarchical linear model fit included random effects for clinic and clinic by time and pre-specified clinic- and patient-level covariates.|Difference is calculated as Integrated Sequenced Care Pathway change minus Coordinated Care Management Pathway change.|Baseline to 12 months||0.21|-0.24|0.890
72338913|NCT04411420|144201390|SUPERIORITY||Median Difference (Final Values)|-0.01||||0.508|TWO_SIDED|95.0|-0.04|0.02||P-values are not adjusted for multiple comparisons. Threshold for significance is 0.05.|Mixed Models Analysis|Hierarchical linear model fit included random effects for clinic and clinic by time and pre-specified clinic- and patient-level covariates.|Difference is calculated as Integrated Sequenced Care Pathway change minus Coordinated Care Management Pathway change.|Baseline to 3 months||0.02|-0.04|0.508
72338914|NCT04411420|144201390|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.992|TWO_SIDED|95.0|-0.03|0.03||P-values are not adjusted for multiple comparisons. Threshold for significance is 0.05.|Mixed Models Analysis|Hierarchical linear model fit included random effects for clinic and clinic by time and pre-specified clinic- and patient-level covariates.|Difference is calculated as Integrated Sequenced Care Pathway change minus Coordinated Care Management Pathway change.|Baseline to 6 months||0.03|-0.03|0.992
72338915|NCT04411420|144201390|SUPERIORITY||Mean Difference (Final Values)|-0.02||||0.389|TWO_SIDED|95.0|-0.05|0.02||P-values are not adjusted for multiple comparisons. Threshold for significance is 0.05.|Mixed Models Analysis|Hierarchical linear model fit included random effects for clinic and clinic by time and pre-specified clinic- and patient-level covariates.|Difference is calculated as Integrated Sequenced Care Pathway change minus Coordinated Care Management Pathway change.|Baseline to 12 months||0.02|-0.05|0.389
72338916|NCT00289198|144201400|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.256|||<|0.001|TWO_SIDED|95.0|-1.73|-0.78||Change from Baseline (Day 1) in reflective total nasal symptom scores for Placebo versus that for fluticasone furoate|ANCOVA|||||-0.78|-1.73|<0.001
72338917|NCT00289198|144201401|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.459|||<|0.001|TWO_SIDED|95.0|-1.93|-0.99||Mean change from Baseline in AM pre-dose instantaneous TNSS over entire period for Placebo versus that for Fluticasone furoate|ANCOVA|||||-0.99|-1.93|<0.001
72338918|NCT00289198|144201402|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|Based on logistic regression adjusting for age, gender and country||||||<0.001
72338919|NCT00289198|144201403|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.274|||<|0.001|TWO_SIDED|95.0|-1.74|-0.81|||ANCOVA|||||-0.81|-1.74|<0.001
72338920|NCT00289198|144201404|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.291|||<|0.001|TWO_SIDED|95.0|-1.77|-0.81|||ANCOVA|||||-0.81|-1.77|<0.001
72338921|NCT00289198|144201405|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.118|||<|0.001|TWO_SIDED|95.0|-20.03|-8.21|||ANCOVA|||||-8.21|-20.03|<0.001
72338922|NCT00289198|144201406|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-20.033|||<|0.001|TWO_SIDED|95.0|-27.13|-12.94|||ANCOVA|||||-12.94|-27.13|<0.001
72338923|NCT00289198|144201407|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.277|||<|0.001|TWO_SIDED|95.0|-0.41|-0.14|||ANCOVA|||Rhinorrhea score, Placebo vs Fluticasone furoate||-0.14|-0.41|<0.001
72338924|NCT00289198|144201407|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.277|||<|0.001|TWO_SIDED|95.0|-0.42|-0.14|||ANCOVA|||Nasal Congestion, Placebo vs Fluticasone furoate||-0.14|-0.42|<0.001
72338925|NCT00289198|144201407|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.331|||<|0.001|TWO_SIDED|95.0|-0.47|-0.2|||ANCOVA|||Nasal Itching, Placebo vs Fluticasone furoate||-0.20|-0.47|<0.001
72338926|NCT00289198|144201407|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.39|||<|0.001|TWO_SIDED|95.0|-0.52|-0.27|||ANCOVA|||Sneezing score, Placebo vs Fluticasone furoate||-0.27|-0.52|<0.001
72338927|NCT00289198|144201408|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.357||||0.001|TWO_SIDED|95.0|-0.5|-0.22|||ANCOVA|||Rhinorrhea score, Placebo versus fluticasone furoate||-0.22|-0.50|0.001
72338928|NCT00289198|144201408|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.37||||0.001|TWO_SIDED|95.0|-0.51|-0.23|||ANCOVA|||Nasal Congestion score, Placebo versus fluticasone furoate||-0.23|-0.51|0.001
72338929|NCT00289198|144201408|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.372||||0.001|TWO_SIDED|95.0|-0.5|-0.24|||ANCOVA|||Nasal itching score, Placebo versus fluticasone furoate||-0.24|-0.50|0.001
72338930|NCT00289198|144201408|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.372||||0.001|TWO_SIDED|95.0|-0.5|-0.24|||ANCOVA|||Sneezing score, Placebo versus fluticasone furoate||-0.24|-0.50|0.001
72338931|NCT00289198|144201409|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.281||||0.001|TWO_SIDED|95.0|-0.42|-0.14|||ANCOVA|||Rhinorrhea score,Placebo versus fluticasone furoate||-0.14|-0.42|0.001
72338932|NCT00289198|144201409|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.314||||0.001|TWO_SIDED|95.0|-0.45|-0.17|||ANCOVA|||Nasal Congestion score, Placebo versus fluticasone furoate||-0.17|-0.45|0.001
72338933|NCT00289198|144201409|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.324||||0.001|TWO_SIDED|95.0|-0.45|-0.19|||ANCOVA|||Nasal itching score, Placebo versus fluticasone furoate||-0.19|-0.45|0.001
72338934|NCT00289198|144201409|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.374||||0.001|TWO_SIDED|95.0|-0.5|-0.25|||ANCOVA|||Sneezing score, Placebo versus fluticasone furoate||-0.25|-0.50|0.001
72338935|NCT00289198|144201410|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.292|||<|0.001||95.0|-0.43|-0.15|||ANCOVA|||Rhinorrhea score, Placebo vs Fluticasone furoate||-0.15|-0.43|<0.001
72338936|NCT00289198|144201410|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.264|||<|0.001|TWO_SIDED|95.0|-0.4|-0.12|||ANCOVA|||Nasal Congestion score, Placebo vs Fluticasone furoate||-0.12|-0.40|<0.001
72338937|NCT00289198|144201410|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.336|||<|0.001|TWO_SIDED|95.0|-0.48|-0.2|||ANCOVA|||Nasal Itching score, Placebo vs Fluticasone furoate||-0.20|-0.48|<0.001
72338938|NCT00289198|144201410|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.412|||<|0.001|TWO_SIDED|95.0|-0.54|-0.28|||ANCOVA|||Sneezing score, Placebo vs Fluticasone furoate||-0.28|-0.54|<0.001
72338939|NCT00289198|144201411|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.506||||0.004|TWO_SIDED|95.0|-0.85|-0.16|||ANCOVA|||||-0.16|-0.85|0.004
72338940|NCT00289198|144201412|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.491||||0.007||95.0|-0.85|-0.13|||ANCOVA|||||-0.13|-0.85|0.007
72338941|NCT00289198|144201413|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.531||||0.003|TWO_SIDED|95.0|-0.88|-0.19|||ANCOVA|||||-0.19|-0.88|0.003
72338942|NCT00289198|144201414|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.496||||0.005|TWO_SIDED|95.0|-0.84|-0.15|||ANCOVA|||||-0.15|-0.84|0.005
72338943|NCT00289198|144201415|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.216||||0.001|TWO_SIDED|95.0|-0.34|-0.09|||ANCOVA|||Eye itching/burning score, Placebo vs fluticasone furoate||-0.09|-0.34|0.001
72338944|NCT00289198|144201415|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.137||||0.028|TWO_SIDED|95.0|-0.26|-0.02|||ANCOVA|||Eye tearing/watering score, Placebo vs fluticasone furoate||-0.02|-0.26|0.028
72338945|NCT00289198|144201415|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.156||||0.01|TWO_SIDED|95.0|-0.27|-0.04|||ANCOVA|||Eye redness, Placebo vs fluticasone furoate||-0.04|-0.27|0.010
72338946|NCT00289198|144201416|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.215||||0.002|TWO_SIDED|95.0|-0.35|-0.08|||ANCOVA|||Eye itching/burning score, Placebo vs fluticasone furoate||-0.08|-0.35|0.002
72338947|NCT00289198|144201416|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.161||||0.016||95.0|-0.29|-0.03|||ANCOVA|||Eye tearing or watering, Placebo vs fluticasone furoate||-0.03|-0.29|0.016
72338948|NCT00289198|144201416|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.113||||0.076|TWO_SIDED|95.0|-0.24|-0.01|||ANCOVA|||Eye redness score, Placebo vs fluticasone furoate||-0.01|-0.24|0.076
72338949|NCT00289198|144201417|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.211||||0.001|TWO_SIDED|95.0|-0.34|-0.08|||ANCOVA|||Eye itching/burning score, Placebo vs Fluticasone furoate||-0.08|-0.34|0.001
72338950|NCT00289198|144201417|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.145||||0.023|TWO_SIDED|95.0|-0.27|-0.02|||ANCOVA|||Eye tearing/watering, Placebo vs Fluticasone furoate||-0.02|-0.27|0.023
72338951|NCT00289198|144201417|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.176||||0.005|TWO_SIDED|95.0|-0.3|-0.05|||ANCOVA|||Eye Redness score, Placebo vs Fluticasone furoate||-0.05|-0.30|0.005
72338952|NCT00289198|144201418|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.223||||0.001|TWO_SIDED|95.0|-0.35|-0.09|||ANCOVA|||Eye itching/burning, Placebo vs fluticasone furoate||-0.09|-0.35|0.001
72338953|NCT00289198|144201418|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.13||||0.04|TWO_SIDED|95.0|-0.25|-0.01|||ANCOVA|||Eye Tearing/Watering score, Placebo vs fluticasone furoate||-0.01|-0.25|0.040
72338954|NCT00289198|144201418|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.142||||0.022|TWO_SIDED|95.0|-0.26|-0.02|||ANCOVA|||Eye Redness score, Placebo vs fluticasone furoate||-0.02|-0.26|0.022
72338955|NCT00289198|144201419|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.376||||0.004|TWO_SIDED|95.0|2.71|14.04|||ANCOVA|||||14.04|2.71|0.004
72338956|NCT00289198|144201420|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.28||||0.002|TWO_SIDED|95.0|3.52|15.04|||ANCOVA|||||15.04|3.52|0.002
72338957|NCT00289198|144201421|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.638||||0.009|TWO_SIDED|95.0|1.89|13.39|||ANCOVA|||||13.39|1.89|0.009
72338958|NCT02406443|144201437|SUPERIORITY||Mean Difference (Final Values)|46.0|||=|0.012|TWO_SIDED||||||Regression, Linear|||||||=0.012
72338959|NCT02406443|144201438|SUPERIORITY||Median Difference (Final Values)|5.7||||0.4|TWO_SIDED||||||Regression, Linear|||||||0.40
72338960|NCT02406443|144201439|SUPERIORITY||Mean Difference (Final Values)|22.0||||0.15|TWO_SIDED||||||Regression, Linear|||||||0.15
72338961|NCT02406443|144201440|SUPERIORITY||Mean Difference (Final Values)|0.5|||<|0.001|TWO_SIDED||||||Regression, Linear|||||||<0.001
72338962|NCT02406443|144201441|SUPERIORITY||Mean Difference (Final Values)|2.4|||<|0.001|TWO_SIDED||||||Regression, Linear|||||||<0.001
72338963|NCT02406443|144201442|SUPERIORITY||Mean Difference (Final Values)|5.7||||0.42|TWO_SIDED||||||Regression, Linear|||||||0.42
72338964|NCT01062061|144201445|SUPERIORITY_OR_OTHER|||||||0.9733||95.0|||||Chi-squared|||||||0.9733
72338965|NCT01062061|144201446|SUPERIORITY_OR_OTHER|||||||0.0001||95.0|||||Chi-squared|||||||0.0001
72338966|NCT03180398|144201506|SUPERIORITY|It was hoped to compare radiomics features, using non-parametric tests, but this was not possible because of the small number of patients accrued.|||||||||||||||||Not enough patients were accrued for radiomics analysis. PI left institution and country. Analysis could not be completed.|||
72338967|NCT03180398|144201507|OTHER|Analysis could not be completed.|||||||||||||||||PI left institution and country. Analysis could not be completed.|||
72338968|NCT01605227|144201508|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.9||||0.213|TWO_SIDED|95.0|0.76|1.06|||Log Rank|The Log-Rank test was stratified by prior cabazitaxel, baseline pain severity and baseline ECOG performance status.||||1.06|0.76|0.213
72338969|NCT01605227|144201509|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel (CMH) Test was stratified by prior cabazitaxel, baseline pain severity and baseline ECOG performance status.||||||<0.001
72338970|NCT01605227|144201510|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.48|||<|0.001|TWO_SIDED|95.0|0.4|0.57|||Log Rank|The Log-Rank Test was stratified by prior cabazitaxel, baseline pain severity, and baseline Eastern Cooperative Oncology Group Performance Status.||||0.57|0.40|<0.001
72338971|NCT03093974|144201515|SUPERIORITY|The number of NCFB pulmonary exacerbations was compared between treatment groups using a negative binomial model including treatment, pooled site (country) and baseline use of stable concomitant therapy with oral macrolides as fixed effects and log-time on treatment as an offset.|LS Mean rate ratio|0.612||||0.00101|TWO_SIDED|95.0|0.457|0.82|||two-sided Wald chi-square test|||||0.820|0.457|0.00101
72338972|NCT01515475|144201584|OTHER||Risk Difference (RD)|3.0||||0.72|TWO_SIDED|95.0|-12.0|18.0|||Barnard's Exact Test|||||18|-12|0.72
72338973|NCT01515475|144201584|OTHER||Risk Difference (RD)|-13.0||||0.14|TWO_SIDED|95.0|-31.0|4.0|||Barnard's Exact Test|||||4|-31|0.14
72338974|NCT01515475|144201592|OTHER||Mean Difference (Final Values)|0.6||||0.002|TWO_SIDED|99.0|0.11|1.09||Results are considered statistically significant if p\<0.01.|ANCOVA|||"Analysis for the more hyperopic eye, Older Cohort:~An analysis of covariance model adjusting for refractive error at enrollment was used to compare mean change in refractive error between treatment groups."||1.09|0.11|0.002
72338975|NCT01515475|144201592|OTHER||Mean Difference (Final Values)|0.58||||0.002|TWO_SIDED|99.0|0.1|1.06||Results are considered statistically significant if p\<0.01.|ANCOVA|||"Analysis for the less hyperopic eye, Older Cohort:~An analysis of covariance model adjusting for refractive error at enrollment was used to compare mean change in refractive error between treatment groups."||1.06|0.10|0.002
72338976|NCT01515475|144201592|OTHER||Mean Difference (Final Values)|0.16||||0.53|TWO_SIDED|99.0|-0.51|0.84||Results are considered statistically significant if p≤0.01.|ANCOVA|||"Analysis for the more hyperopic eye, Younger Cohort:~An analysis of covariance model adjusting for refractive error at enrollment was used to compare mean change in refractive error between treatment groups."||0.84|-0.51|0.53
72338977|NCT01515475|144201592|OTHER||Mean Difference (Final Values)|0.22||||0.38|TWO_SIDED|99.0|-0.43|0.86||Results are considered statistically significant if p≤0.01.|ANCOVA|||"Analysis for the less hyperopic eye, Younger Cohort:~An analysis of covariance model adjusting for refractive error at enrollment was used to compare mean change in refractive error between treatment groups."||0.86|-0.43|0.38
72338978|NCT01515475|144201593|OTHER||Mean Difference (Final Values)|-25.0||||0.013|TWO_SIDED|99.0|-49.0|1.0||Results are considered statistically significant if p\<0.01.|Barnard's Exact Test|||"Analysis for the more hyperopic eye:~Barnard's exact test was used to compare proportions between treatment groups."||1|-49|0.013
72338979|NCT01515475|144201593|OTHER||Hazard Ratio, log|-18.0||||0.08|TWO_SIDED|99.0|-42.0|8.0||Results are considered statistically significant if p\<0.01.|Barnard's Exact Test|||"Analysis for the less hyperopic eye:~Barnard's exact test was used to compare proportions between treatment groups."||8|-42|0.08
72338980|NCT01515475|144201594|OTHER||Mean Difference (Final Values)|0.01||||0.22|TWO_SIDED|99.0|-0.02|0.04|||ANCOVA|||"Test for Difference in Means in Better-Seeing Eye: Older Cohort~An analysis of covariance model, adjusting for age at the 3-year visit and visual acuity at baseline, was used to compare mean visual acuity between treatment groups. Results are considered statistically significant if p\<0.01."||0.04|-0.02|0.22
72338981|NCT01515475|144201594|OTHER||Mean Difference (Final Values)|-0.02||||0.41|TWO_SIDED|99.0|-0.06|0.03|||ANCOVA|||"Test for Difference in Means in Worse-Seeing Eye: Older Cohort~An analysis of covariance model, adjusting for age at the 3-year visit and visual acuity at baseline, was used to compare mean visual acuity between treatment groups. Results are considered statistically significant if p\<0.01."||0.03|-0.06|0.41
72338982|NCT01515475|144201594|OTHER||Mean Difference (Final Values)|-0.05||||0.02|TWO_SIDED|99.0|-0.12|0.01|||ANCOVA|||"Test for Difference in Means in Better-Seeing Eye: Younger Cohort~An analysis of covariance model, adjusting for age at the 3-year visit and visual acuity at baseline, was used to compare mean visual acuity between treatment groups. Results are considered statistically significant if p\<0.01."||0.01|-0.12|0.02
72338983|NCT01515475|144201594|OTHER||Mean Difference (Final Values)|-0.07||||0.15|TWO_SIDED|99.0|-0.19|0.05|||ANCOVA|||"Test for Difference in Means in Worse-Seeing Eye: Younger Cohort~An analysis of covariance model, adjusting for age at the 3-year visit and visual acuity at baseline, was used to compare mean visual acuity between treatment groups. Results are considered statistically significant if p\<0.01."||0.05|-0.19|0.15
72338984|NCT01515475|144201595|OTHER||Mean Difference (Final Values)|-2.0||||0.51|TWO_SIDED|99.0|-18.0|13.0||Results are considered statistically significant if p\<0.01.|Barnard's Exact Test|||Barnard's exact test was used to compare proportions between treatment groups.||13|-18|0.51
72338985|NCT01515475|144201595|OTHER||Mean Difference (Final Values)|-2.0||||0.79|TWO_SIDED|99.0|-18.0|14.0||Results are considered statistically significant if p\<0.01.|Barnard's Exact Test|||Barnard's exact test was used to compare proportions between treatment groups.||14|-18|0.79
72338986|NCT01515475|144201596|OTHER||Mean Difference (Final Values)|-2.0||||0.51|TWO_SIDED|99.0|-18.0|13.0||Results are considered statistically significant if p\<0.01.|Barnard's Exact Test|||Barnard's exact test was used to compare proportions between treatment groups.||13|-18|0.51
72338987|NCT01515475|144201596|OTHER||Mean Difference (Final Values)|-4.0||||0.68|TWO_SIDED|99.0|-24.0|16.0||Results are considered statistically significant if p≤0.01.|Barnard's Exact Test|||Barnard's exact test was used to compare proportions between treatment groups.||16|-24|0.68
72338988|NCT01515475|144201597|OTHER||Mean Difference (Final Values)|-0.04||||0.21|TWO_SIDED|99.0|-0.12|0.05||Results are considered statistically significant if p\<0.01|ANCOVA|||An analysis of covariance model, adjusting for age at the 3-year visit and visual acuity at baseline, was used to compare mean visual acuity between treatment groups.||0.05|-0.12|0.21
72338989|NCT01515475|144201597|OTHER||Mean Difference (Final Values)|-0.03||||0.25|TWO_SIDED|99.0|-0.1|0.04||Results are considered statistically significant if p≤0.01.|ANCOVA|||An analysis of covariance model, adjusting for age at the 3-year visit and visual acuity at baseline, was used to compare mean visual acuity between treatment groups.||0.04|-0.10|0.25
72338990|NCT01515475|144201598|OTHER||Mean Difference (Final Values)|-2.0||||0.51|TWO_SIDED|99.0|-18.0|13.0||Results are considered statistically significant if p\<0.01.|Barnard's Exact Test|||Barnard's exact test used to compare proportions between treatment groups||13|-18|0.51
72338991|NCT01515475|144201598|OTHER||Mean Difference (Final Values)|0.0|||||TWO_SIDED|99.0|-17.0|17.0||No p-value, because there was 0% difference||||Barnard's exact test used to compare proportions between treatment groups.||17|-17|
72338992|NCT01515475|144201599|OTHER||Mean Difference (Final Values)|0.02||||0.74|TWO_SIDED|99.0|-0.11|0.14||Results are considered statistically significant if p\<0.01.|ANCOVA|||An analysis of covariance model was used to compare mean change in stereoacuity between treatment groups. The analysis controlled for age at the 3-year visit, anisometropia at the most recent visit, and stereoacuity at enrollment.||0.14|-0.11|0.74
72338993|NCT01515475|144201599|OTHER||Mean Difference (Final Values)|-0.1||||0.15|TWO_SIDED|99.0|-0.4|0.1|||ANCOVA|||An analysis of covariance model was used to compare mean change in stereoacuity between treatment groups. The analysis controlled for age at the 3-year visit and anisometropia at the most recent visit.||0.1|-0.4|0.15
72338994|NCT01515475|144201600|OTHER||Mean Difference (Final Values)|5.0||||0.53|TWO_SIDED|99.0|-14.0|26.0||Results are considered statistically significant if p\<0.01.|Barnard's Exact Test|||Barnard's exact test used to compare proportions between treatment groups||26|-14|0.53
72338995|NCT01515475|144201600|OTHER||Mean Difference (Final Values)|-19.0||||0.02|TWO_SIDED|99.0|-40.0|2.0||Results are considered statistically significant if p\<0.01.|Barnard's Exact Test|||Barnard's exact test used to compare proportions between treatment groups.||2|-40|0.02
72338996|NCT01511809|144201629|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|A lower limit of the 95% confidence interval of the difference between the two proportions of treatment failure (triple therapy-monotherapy) below the pre-specified margin of non-inferiority of -10% established inferiority. A sample size of 342 patients (171 per treatment arm) provided 80% power (one-sided, alpha 0.05) to establish non-inferiority of ATV/r monotherapy as compared to ATV/r triple therapy with an overall treatment failure (TF) rate of 15% at week 48.|difference between TF proportions|15.0|||||TWO_SIDED|||||||||"Here are reported the results of the 48-week interim analyses according to the intention-to-treat (ITT) principle. ITT=F (with re-intensification=failure) and the ITT=S (with re-intensification=success) treatment failure results are shown.~Based on the efficacy data review, in June 2013, an independent Data and Safety Monitoring Board (DSMB) recommended to stop further patients' enrolment and to follow-up the enrolled patients until 96 weeks, after having signed an updated informed consent."||||
72338997|NCT00130923|144201631|SUPERIORITY||difference in treatment slopes|-0.043|STANDARD_ERROR_OF_MEAN|0.021||0.054|TWO_SIDED||||||Mixed Models Analysis||We report the estimated coefficient for difference in treatment slopes in a mixed model and its standard error.|||||0.054
72338998|NCT00130923|144201632|SUPERIORITY||Difference in treatment means|-0.62|STANDARD_ERROR_OF_MEAN|0.29||0.035|TWO_SIDED||||||Mixed Models Analysis||We report the estimated coefficient for difference in treatment means in a mixed model and its standard error.|||||.035
72338999|NCT00130923|144201633|SUPERIORITY||difference in treatment means|0.056|STANDARD_ERROR_OF_MEAN|0.099||0.57|TWO_SIDED||||||Mixed Models Analysis||We report the estimated coefficient for difference in treatment means in a mixed model and its standard error.|||||.57
72339000|NCT00130923|144201634|SUPERIORITY||difference in treatment means|2.65|STANDARD_ERROR_OF_MEAN|2.68||0.32|TWO_SIDED||||||Mixed Models Analysis||We report the estimated coefficient difference in treatment means in a mixed model and its standard error.|||||.32
72339001|NCT00130923|144201635|SUPERIORITY||difference in treatment means|0.93|STANDARD_ERROR_OF_MEAN|1.19||0.44|TWO_SIDED||||||Mixed Models Analysis||We report the estimated coefficient for difference in treatment means in a mixed model and its standard error.|||||.44
72339002|NCT00130923|144201636|SUPERIORITY|||||||0.003|||||||Chi-squared|Statistical test of hypothesis. Value of the Chi-squared statistic is 9.08||||||.003
72339003|NCT02256267|144201640|SUPERIORITY_OR_OTHER||Ratio of Geometric Least Squares Means|0.0771|||||TWO_SIDED|90.0|0.0671|0.0886||||||||0.0886|0.0671|
72339004|NCT02256267|144201641|SUPERIORITY_OR_OTHER||Ratio of Geometric Least Squares Means|0.0467|||||TWO_SIDED|90.0|0.0376|0.0581||||||||0.0581|0.0376|
72339005|NCT02818114|144201643|OTHER|Assessment of number of PE sessions attended, review of direction of change in PTSD Checklist scores||||||||||||||||This is a single-arm feasibility study. With N=8, formal hypothesis testing is not possible. We were assessing the extent to which veterans would be willing to engage in the intervention, and if the direction of change in symptoms is still in the expected direction when peer support services are added. Outcomes are reported more qualitatively.|As a feasibility trial, tests of statistical significance are not appropriate.|||
72339006|NCT04557787|144201644|SUPERIORITY||Mean Difference (Final Values)|28.4||||0.001|TWO_SIDED|95.0|12.2|44.6||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||44.6|12.2|0.001
72339007|NCT04557787|144201644|SUPERIORITY||Mean Difference (Final Values)|28.2||||0.001|TWO_SIDED|95.0|12.0|44.4||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||44.4|12.0|0.001
72339008|NCT04557787|144201644|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.983|TWO_SIDED|95.0|-16.0|16.3||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||16.3|-16.0|0.983
72339009|NCT04557787|144201645|SUPERIORITY||Mean Difference (Final Values)|33.2|||<|0.001|TWO_SIDED|95.0|17.0|49.4||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||49.4|17.0|<0.001
72339010|NCT04557787|144201645|SUPERIORITY||Mean Difference (Final Values)|29.7|||<|0.001|TWO_SIDED|95.0|13.5|46.0||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||46.0|13.5|<0.001
72339011|NCT04557787|144201645|SUPERIORITY||Mean Difference (Final Values)|3.5||||0.667|TWO_SIDED|95.0|-12.6|19.7||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||19.7|-12.6|0.667
72339012|NCT04557787|144201646|SUPERIORITY||Mean Difference (Final Values)|-3.6||||0.503|TWO_SIDED|95.0|-14.2|7.0||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||7.0|-14.2|0.503
72339013|NCT04557787|144201646|SUPERIORITY||Mean Difference (Final Values)|0.5||||0.916|TWO_SIDED|95.0|-10.1|11.2||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||11.2|-10.1|0.916
72339014|NCT04557787|144201646|SUPERIORITY||Mean Difference (Final Values)|-4.1||||0.438|TWO_SIDED|95.0|-14.8|6.5||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied||6.5|-14.8|0.438
72339015|NCT04557787|144201647|SUPERIORITY||Mean Difference (Final Values)|0.3||||0.955|TWO_SIDED|95.0|-10.3|10.9||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||10.9|-10.3|0.955
72339016|NCT04557787|144201647|SUPERIORITY||Mean Difference (Final Values)|-8.5||||0.118|TWO_SIDED|95.0|-19.2|2.2||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||2.2|-19.2|0.118
72339017|NCT04557787|144201647|SUPERIORITY||Mean Difference (Final Values)|8.8||||0.104|TWO_SIDED|95.0|-1.8|19.5||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||19.5|-1.8|0.104
72339018|NCT04557787|144201648|SUPERIORITY||Mean Difference (Final Values)|0.19||||0.352|TWO_SIDED|95.0|-0.22|0.6||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.60|-0.22|0.352
72339019|NCT04557787|144201648|SUPERIORITY||Mean Difference (Final Values)|-0.01||||0.98|TWO_SIDED|95.0|-0.41|0.4||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.40|-0.41|0.980
72339020|NCT04557787|144201648|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.339|TWO_SIDED|95.0|-0.21|0.6||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.60|-0.21|0.339
72339021|NCT04557787|144201649|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.7|TWO_SIDED|95.0|-0.62|0.42||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.42|-0.62|0.700
72339022|NCT04557787|144201649|SUPERIORITY||Mean Difference (Final Values)|0.32||||0.227|TWO_SIDED|95.0|-0.2|0.84||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.84|-0.20|0.227
72339023|NCT04557787|144201649|SUPERIORITY||Mean Difference (Final Values)|-0.42||||0.112|TWO_SIDED|95.0|-0.94|0.1||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.10|-0.94|0.112
72339024|NCT04557787|144201650|SUPERIORITY||Mean Difference (Final Values)|0.99||||0.013|TWO_SIDED|95.0|0.22|1.17||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||1.17|0.22|0.013
72339025|NCT04557787|144201650|SUPERIORITY||Mean Difference (Final Values)|0.73||||0.065|TWO_SIDED|95.0|-0.05|1.51||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||1.51|-0.05|0.065
72339026|NCT04557787|144201650|SUPERIORITY||Mean Difference (Final Values)|0.27||||0.497|TWO_SIDED|95.0|-0.51|1.04||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||1.04|-0.51|0.497
72339027|NCT04557787|144201651|SUPERIORITY||Mean Difference (Final Values)|0.47||||0.027|TWO_SIDED|95.0|0.06|0.88||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.88|0.06|0.027
72339028|NCT04557787|144201651|SUPERIORITY||Mean Difference (Final Values)|0.6||||0.005|TWO_SIDED|95.0|0.19|1.02||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||1.02|0.19|0.005
72339029|NCT04557787|144201651|SUPERIORITY||Mean Difference (Final Values)|-0.13||||0.532|TWO_SIDED|95.0|-0.54|0.28||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.28|-0.54|0.532
72339030|NCT04557787|144201652|SUPERIORITY||Mean Difference (Final Values)|0.15||||0.461|TWO_SIDED|95.0|-0.26|0.56||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.56|-0.26|0.461
72339031|NCT04557787|144201652|SUPERIORITY||Mean Difference (Final Values)|0.32||||0.12|TWO_SIDED|95.0|-0.09|0.73||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.73|-0.09|0.120
72339032|NCT04557787|144201652|SUPERIORITY||Mean Difference (Final Values)|-0.17||||0.404|TWO_SIDED|95.0|-0.58|0.24||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.24|-0.58|0.404
72339033|NCT04557787|144201653|SUPERIORITY||Mean Difference (Final Values)|0.19||||0.478|TWO_SIDED|95.0|-0.33|0.71||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.71|-0.33|0.478
72339034|NCT04557787|144201653|SUPERIORITY||Mean Difference (Final Values)|0.06||||0.824|TWO_SIDED|95.0|-0.46|0.58||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.58|-0.46|0.824
72339035|NCT04557787|144201653|SUPERIORITY||Mean Difference (Final Values)|0.13||||0.626|TWO_SIDED|95.0|-0.39|0.65||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.65|-0.39|0.626
72339036|NCT04557787|144201654|SUPERIORITY||Mean Difference (Final Values)|0.86||||0.03|TWO_SIDED|95.0|0.09|1.64||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||1.64|0.09|0.030
72339037|NCT04557787|144201654|SUPERIORITY||Mean Difference (Final Values)|0.88||||0.027|TWO_SIDED|95.0|0.11|1.66||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||1.66|0.11|0.027
72339038|NCT04557787|144201654|SUPERIORITY||Mean Difference (Final Values)|-0.02||||0.956|TWO_SIDED|95.0|-0.8|0.75||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.75|-0.80|0.956
72339039|NCT04557787|144201655|SUPERIORITY||Mean Difference (Final Values)|0.36||||0.084|TWO_SIDED|95.0|-0.05|0.78||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.78|-0.05|0.084
72339040|NCT04557787|144201655|SUPERIORITY||Mean Difference (Final Values)|0.39||||0.063|TWO_SIDED|95.0|-0.02|0.81||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.81|-0.02|0.063
72339041|NCT04557787|144201655|SUPERIORITY||Mean Difference (Final Values)|-0.03||||0.885|TWO_SIDED|95.0|-0.44|0.38||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.38|-0.44|0.885
72428325|NCT02471404|144367544|NON_INFERIORITY|The non-inferiority (NI) margin was determined to be 0.30% (in absolute terms). A difference of ≤0.30%, in HbA1c change from b/l to wk 52 between the treatment groups was considered clinically equivalent. NI was assessed using the 2-sided 95% CI of adjusted mean difference between dapagliflozin or dapagliflozin plus saxagliptin and glimepiride.|Mean Difference (Final Values)|0.16|||||TWO_SIDED|95.0|0.0294|0.2986|||Mixed Models Analysis|||||0.2986|0.0294|
72339042|NCT01969500|144201660|SUPERIORITY||Mean Difference (Final Values)|-0.71|STANDARD_ERROR_OF_MEAN|3.81||0.85|TWO_SIDED|95.0|-8.37|6.96|||Linear mixed effects model||Mean difference (Intervention Arm - TAU) in change from baseline to 12 weeks|||6.96|-8.37|.85
72339043|NCT01969500|144201661|SUPERIORITY||Mean Difference (Final Values)|-1.3|STANDARD_ERROR_OF_MEAN|1.67||0.44|TWO_SIDED|95.0|-4.66|2.06|||Linear mixed effects model||Mean difference (Intervention Arm - TAU) in change from baseline to 12 weeks|||2.06|-4.66|.44
72339044|NCT00613080|144201685|SUPERIORITY_OR_OTHER||Proportion (reported as percentage)|51.0||||0.93|TWO_SIDED||||||Chi-squared|||This study was designed for a one-sided chi-square test to detect at least 12% reduction in the 40% rate of ≥ grade 2 treatment-related preoperative GI AEs from the conventional radiotherapy / capecitabine /oxaliplatin arm of study RTOG-0247 (NCT00081289) with 80% power and a one-sided type I error rate of 0.10.||||0.93
72339045|NCT02726880|144201723|SUPERIORITY||F|1.13||||0.296|TWO_SIDED||||||ANCOVA|Number of days of gaming in the past week, measured at baseline, is included as a covariate in the model.||||||.296
72339046|NCT02945553|144201735|OTHER|Mixed model analysis of variance|Mean Difference (Final Values)|1596.0|STANDARD_DEVIATION|202.0|<|0.05|TWO_SIDED||||||ANOVA|||||||<0.05
72339047|NCT02945553|144201740|OTHER||Mean Difference (Net)|30.0|||<|0.05|TWO_SIDED||||||t-test, 2 sided|||||||<0.05
72339048|NCT03553498|144201741|SUPERIORITY|||||||0.08|||||||t-test, 2 sided|||||||0.08
72339049|NCT03553498|144201742|SUPERIORITY|||||||0.989|||||||Chi-squared|||||||0.989
72339050|NCT03553498|144201743|SUPERIORITY|||||||0.414|||||||Chi-squared|||||||0.414
72339051|NCT03553498|144201744|SUPERIORITY|||||||0.153|||||||Chi-squared|||||||0.153
72339052|NCT02741570|144201749|SUPERIORITY||Hazard Ratio (HR)|0.78||||0.0469|TWO_SIDED|97.51|0.59|1.03|||Log Rank|stratified regular log-rank test||||1.03|0.59|0.0469
72339053|NCT02741570|144201750|SUPERIORITY||Cox Proportional Hazard|0.95||||0.4951|TWO_SIDED|97.9|0.8|1.13|||Log Rank|stratified regular log-rank test||||1.13|0.80|0.4951
72339054|NCT02741570|144201751|SUPERIORITY||Cox Proportional Hazard|0.8|||||TWO_SIDED|95.0|0.68|0.95||||||||0.95|0.68|
72339055|NCT02741570|144201752|SUPERIORITY||Cox Proportional Hazard|1.4|||||TWO_SIDED|95.0|1.19|1.63|||||All Randomized Participants|||1.63|1.19|
72339056|NCT02741570|144201752|SUPERIORITY||Cox Proportional Hazard|1.0|||||TWO_SIDED|95.0|0.77|1.3|||||All Randomized PD-L1 CPS \>= 20 Participants|||1.30|0.77|
72339057|NCT02741570|144201755|SUPERIORITY||Hazard Ratio (HR)|0.76|||||TWO_SIDED|95.0|0.6|0.97||||||||0.97|0.60|
72339058|NCT02741570|144201756|SUPERIORITY||Cox Proportional Hazard|0.94|||||TWO_SIDED|95.0|0.82|1.08||||||||1.08|0.82|
72339059|NCT02700165|144201786|OTHER||sucess proportion|78.6|||||TWO_SIDED|95.0|49.2|95.3|||||Independent physician reviewers correctly identified 13/14, 11/14 and 10/14, respectively for an overall percentage of correct identification of 34/42 or 81%. Two of three reviewers correctly identified 11/14 (78.6%) photos.|||95.3|49.2|
72339060|NCT02011490|144201790|SUPERIORITY_OR_OTHER||Geometric least squares mean ratio|5.42|||||TWO_SIDED|90.0|4.12|7.11|||||Difference in least squares means of log-transformed data (severe renal impaired - healthy) was back transformed to geometric least squares mean ratio (severe renal impaired/healthy)|Log-transformed plasma values were modeled using an analysis of variance (ANOVA) linear fixed-effect model with population (severe insufficiency, moderate insufficiency, and healthy control) as a fixed effect||7.11|4.12|
72339061|NCT02011490|144201790|SUPERIORITY_OR_OTHER||Geometric least squares mean ratio|2.42|||||TWO_SIDED|90.0|1.84|3.17|||||Difference in least squares means of log-transformed data (moderate renal impaired - healthy) was back transformed to geometric least squares mean ratio (moderate renal impaired/healthy)|Log-transformed plasma values were modeled using an ANOVA linear fixed-effect model with population (severe insufficiency, moderate insufficiency, and healthy control) as a fixed effect||3.17|1.84|
72339062|NCT02011490|144201791|SUPERIORITY_OR_OTHER||Geometric least squares mean ratio|5.49|||||TWO_SIDED|90.0|4.18|7.22|||||Difference in least squares means of log-transformed data (severe renal impaired - healthy) was back transformed to geometric least squares mean ratio (severe renal impaired/healthy)|Log-transformed plasma values were modeled using an ANOVA linear fixed-effect model with population (severe insufficiency, moderate insufficiency, and healthy control) as a fixed effect||7.22|4.18|
72339063|NCT02011490|144201791|SUPERIORITY_OR_OTHER||Geometric least squares mean ratio|2.42|||||TWO_SIDED|90.0|1.84|3.18|||||Difference in least squares means of log-transformed data (moderate renal impaired - healthy) was back transformed to geometric least squares mean ratio (moderate renal impaired/healthy)|Log-transformed plasma values were modeled using an ANOVA linear fixed-effect model with population (severe insufficiency, moderate insufficiency, and healthy control) as a fixed effect||3.18|1.84|
72339064|NCT02011490|144201792|SUPERIORITY_OR_OTHER||Geometric least squares mean ratio|0.94|||||TWO_SIDED|90.0|0.73|1.21|||||Difference in least squares means of log-transformed data (severe renal impaired - healthy) was back transformed to geometric least squares mean ratio (severe renal impaired/healthy)|Log-transformed plasma values were modeled using an ANOVA linear fixed-effect model with population (severe insufficiency, moderate insufficiency, and healthy control) as a fixed effect||1.21|0.73|
72339065|NCT02011490|144201792|SUPERIORITY_OR_OTHER||Geometric least squares mean ratio|0.92|||||TWO_SIDED|90.0|0.72|1.18|||||Difference in least squares means of log-transformed data (moderate renal impaired - healthy) was back transformed to geometric least squares mean ratio (moderate renal impaired/healthy)|Log-transformed plasma values were modeled using an ANOVA linear fixed-effect model with population (severe insufficiency, moderate insufficiency, and healthy control) as a fixed effect||1.18|0.72|
72339066|NCT03697993|144201810|OTHER||Risk Difference (RD)|-18.0||||0.264|TWO_SIDED|95.0|-43.4|8.7|||Multiple imputation using Wald method|||||8.7|-43.4|0.264
72339067|NCT03697993|144201814|OTHER||Risk Difference (RD)|-1.0||||1|TWO_SIDED|95.0|-26.2|24.3|||Fisher Exact|||||24.3|-26.2|1.000
72339068|NCT03697993|144201815|OTHER||Odds Ratio (OR)|0.9||||0.894|TWO_SIDED|95.0|0.3|2.5|||Proportional odds model using Wald test|||||2.5|0.3|0.894
72339069|NCT03697993|144201816|OTHER||Risk Difference (RD)|0.0||||0.973|TWO_SIDED|95.0|-26.3|25.3|||Multiple imputation using Wald method|||||25.3|-26.3|0.973
72339070|NCT04384107|144201819|OTHER|Estimated differences, confidence intervals (CIs), and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percent|-1.1|||=|0.641|TWO_SIDED|95.0|-5.9|3.6|||Miettinen & Nurminen|||Injection site erythema||3.6|-5.9|= 0.641
72339071|NCT04384107|144201819|OTHER|Estimated differences, confidence intervals (CIs), and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percent|-0.2|||=|0.937|TWO_SIDED|95.0|-6.1|5.6|||Miettinen & Nurminen|||Injection site induration||5.6|-6.1|= 0.937
72339072|NCT04384107|144201819|OTHER|Estimated differences, confidence intervals (CIs), and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percent|7.1|||=|0.036|TWO_SIDED|95.0|0.5|13.8|||Miettinen & Nurminen|||Injection site pain||13.8|0.5|= 0.036
72339073|NCT04384107|144201819|OTHER|Estimated differences, confidence intervals (CIs), and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percent|-4.0|||=|0.208|TWO_SIDED|95.0|-10.2|2.2|||Miettinen & Nurminen|||Injection site swelling||2.2|-10.2|= 0.208
72339074|NCT04384107|144201820|OTHER|Estimated differences, confidence intervals (CIs), and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percent|-0.4|||=|0.912|TWO_SIDED|95.0|-6.7|6.0|||Miettinen & Nurminen|||Decreased appetite||6.0|-6.7|= 0.912
72339075|NCT04384107|144201820|OTHER|Estimated differences, confidence intervals (CIs), and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percent|5.9|||=|0.108|TWO_SIDED|95.0|-1.3|13.0|||Miettinen & Nurminen|||Irritability||13.0|-1.3|= 0.108
72339076|NCT04384107|144201820|OTHER|Estimated differences, confidence intervals (CIs), and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percent|1.0|||=|0.792|TWO_SIDED|95.0|-6.4|8.4|||Miettinen & Nurminen|||Somnolence||8.4|-6.4|= 0.792
72339077|NCT04384107|144201820|OTHER|Estimated differences, confidence intervals (CIs), and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percent|-0.3|||=|0.843|TWO_SIDED|95.0|-3.5|2.8|||Miettinen & Nurminen|||Urticaria||2.8|-3.5|= 0.843
72339078|NCT04384107|144201821|OTHER|Estimated differences and CIs are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percent|0.0|||||TWO_SIDED|95.0|-1.4|1.3||||||||1.3|-1.4|
72339079|NCT04384107|144201822|NON_INFERIORITY|The stratum-adjusted proportion difference using the Cochran-Mantel-Haenszel weight, and the corresponding 95% CI and p-value based on the method of Miettinen and Nurminen stratified by age category. A conclusion of non-inferiority of V114 to PCV13 is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - PCV13) being \>-10 percentage points (1-sided p-value \<0.025).|Difference in Percent|-0.3|||<|0.001|TWO_SIDED|95.0|-1.7|0.8|||Miettinen and Nurminen|||Serotype 1: Participants With IgG ≥0.35 μg/mL||0.8|-1.7|< 0.001
72339080|NCT04384107|144201822|NON_INFERIORITY|The stratum-adjusted proportion difference using the Cochran-Mantel-Haenszel weight, and the corresponding 95% CI and p-value based on the method of Miettinen and Nurminen stratified by age category. A conclusion of non-inferiority of V114 to PCV13 is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - PCV13) being \>-10 percentage points (1-sided p-value \<0.025).|Difference in Percent|2.3|||<|0.001|TWO_SIDED|95.0|1.0|4.5|||Miettinen and Nurminen|||Serotype 3: Participants With IgG ≥0.35 μg/mL||4.5|1.0|< 0.001
72339081|NCT04384107|144201822|NON_INFERIORITY|The stratum-adjusted proportion difference using the Cochran-Mantel-Haenszel weight, and the corresponding 95% CI and p-value based on the method of Miettinen and Nurminen stratified by age category. A conclusion of non-inferiority of V114 to PCV13 is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - PCV13) being \>-10 percentage points (1-sided p-value \<0.025).|Difference in Percent|0.0|||<|0.001|TWO_SIDED|95.0|-1.1|1.1|||Miettinen and Nurminen|||Serotype 4: Participants With IgG ≥0.35 μg/mL||1.1|-1.1|< 0.001
72339082|NCT04384107|144201822|NON_INFERIORITY|The stratum-adjusted proportion difference using the Cochran-Mantel-Haenszel weight, and the corresponding 95% CI and p-value based on the method of Miettinen and Nurminen stratified by age category. A conclusion of non-inferiority of V114 to PCV13 is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - PCV13) being \>-10 percentage points (1-sided p-value \<0.025).|Difference in Percent|-1.2|||<|0.001|TWO_SIDED|95.0|-3.0|-0.1|||Miettinen and Nurminen|||Serotype 5: Participants With IgG ≥0.35 μg/mL||-0.1|-3.0|< 0.001
72339083|NCT04384107|144201822|NON_INFERIORITY|The stratum-adjusted proportion difference using the Cochran-Mantel-Haenszel weight, and the corresponding 95% CI and p-value based on the method of Miettinen and Nurminen stratified by age category. A conclusion of non-inferiority of V114 to PCV13 is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - PCV13) being \>-10 percentage points (1-sided p-value \<0.025).|Difference in Percent|-0.9|||<|0.001|TWO_SIDED|95.0|-2.6|0.2|||Miettinen and Nurminen|||Serotype 6A: Participants With IgG ≥0.35 μg/mL||0.2|-2.6|< 0.001
72369993|NCT02260180|144250384|OTHER||||||<|0.0001||||||No adjustment for multiple comparisons were conducted.|ANCOVA|Baseline PLA was the covariate. Comparisons were performed within the model using least-squares means and the common error term.||The primary efficacy analysis of mean change from baseline to Visit 8 PLA was performed using analysis of covariance (ANCOVA) with baseline PLA as the covariate. Comparisons between vehicle and each A-101 group were performed within the model using least-squares means and the common error term.||||<0.0001
72369994|NCT03860818|144250394|SUPERIORITY||||||<|0.001|||||||Chi-squared|||Rate of inpatient hospitalization during study||||<.001
72369995|NCT03860818|144250394|SUPERIORITY||||||<|0.0001|||||||Chi-squared|||||||<.0001
72369996|NCT03860818|144250395|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|Statistical analysis applies to all rows.||||||<0.001
72369997|NCT03860818|144250396|SUPERIORITY|||||||0.9064|||||||Chi-squared|||||||0.9064
72369998|NCT03860818|144250397|SUPERIORITY|||||||0.51|||||||Chi-squared|||||||0.51
72339084|NCT04384107|144201822|NON_INFERIORITY|The stratum-adjusted proportion difference using the Cochran-Mantel-Haenszel weight, and the corresponding 95% CI and p-value based on the method of Miettinen and Nurminen stratified by age category. A conclusion of non-inferiority of V114 to PCV13 is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - PCV13) being \>-10 percentage points (1-sided p-value \<0.025).|Difference in Percent|-3.9|||<|0.001|TWO_SIDED|95.0|-6.9|-1.3|||Miettinen and Nurminen|||Serotype 6B: Participants With IgG ≥0.35 μg/mL||-1.3|-6.9|< 0.001
72339085|NCT04384107|144201822|NON_INFERIORITY|The stratum-adjusted proportion difference using the Cochran-Mantel-Haenszel weight, and the corresponding 95% CI and p-value based on the method of Miettinen and Nurminen stratified by age category. A conclusion of non-inferiority of V114 to PCV13 is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - PCV13) being \>-10 percentage points (1-sided p-value \<0.025).|Difference in Percent|-0.3|||<|0.001|TWO_SIDED|95.0|-1.7|0.8|||Miettinen and Nurminen|||Serotype 7F: Participants With IgG ≥0.35 μg/mL||0.8|-1.7|< 0.001
72339086|NCT04384107|144201822|NON_INFERIORITY|The stratum-adjusted proportion difference using the Cochran-Mantel-Haenszel weight, and the corresponding 95% CI and p-value based on the method of Miettinen and Nurminen stratified by age category. A conclusion of non-inferiority of V114 to PCV13 is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - PCV13) being \>-10 percentage points (1-sided p-value \<0.025).|Difference in Percent|-0.3|||<|0.001|TWO_SIDED|95.0|-1.7|0.8|||Miettinen and Nurminen|||Serotype 9V: Participants With IgG ≥0.35 μg/mL||0.8|-1.7|< 0.001
72339087|NCT04384107|144201822|NON_INFERIORITY|The stratum-adjusted proportion difference using the Cochran-Mantel-Haenszel weight, and the corresponding 95% CI and p-value based on the method of Miettinen and Nurminen stratified by age category. A conclusion of non-inferiority of V114 to PCV13 is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - PCV13) being \>-10 percentage points (1-sided p-value \<0.025).|Difference in Percent|-0.3|||<|0.001|TWO_SIDED|95.0|-1.9|1.1|||Miettinen and Nurminen|||Serotype 14: Participants With IgG ≥0.35 μg/mL||1.1|-1.9|< 0.001
72339088|NCT04384107|144201822|NON_INFERIORITY|The stratum-adjusted proportion difference using the Cochran-Mantel-Haenszel weight, and the corresponding 95% CI and p-value based on the method of Miettinen and Nurminen stratified by age category. A conclusion of non-inferiority of V114 to PCV13 is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - PCV13) being \>-10 percentage points (1-sided p-value \<0.025).|Difference in Percent|-1.2|||<|0.001|TWO_SIDED|95.0|-3.0|-0.1|||Miettinen and Nurminen|||Serotype 18C: Participants With IgG ≥0.35 μg/mL||-0.1|-3.0|< 0.001
72339089|NCT04384107|144201822|NON_INFERIORITY|The stratum-adjusted proportion difference using the Cochran-Mantel-Haenszel weight, and the corresponding 95% CI and p-value based on the method of Miettinen and Nurminen stratified by age category. A conclusion of non-inferiority of V114 to PCV13 is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - PCV13) being \>-10 percentage points (1-sided p-value \<0.025).|Difference in Percent|-0.3|||<|0.001|TWO_SIDED|95.0|-1.7|0.8|||Miettinen and Nurminen|||Serotype 19A: Participants With IgG ≥0.35 μg/mL||0.8|-1.7|< 0.001
72339090|NCT04384107|144201822|NON_INFERIORITY|The stratum-adjusted proportion difference using the Cochran-Mantel-Haenszel weight, and the corresponding 95% CI and p-value based on the method of Miettinen and Nurminen stratified by age category. A conclusion of non-inferiority of V114 to PCV13 is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - PCV13) being \>-10 percentage points (1-sided p-value \<0.025).|Difference in Percent|0.0|||<|0.001|TWO_SIDED|95.0|-1.1|1.1|||Miettinen and Nurminen|||Serotype 19F: Participants With IgG ≥0.35 μg/mL||1.1|-1.1|< 0.001
72339091|NCT04384107|144201822|NON_INFERIORITY|The stratum-adjusted proportion difference using the Cochran-Mantel-Haenszel weight, and the corresponding 95% CI and p-value based on the method of Miettinen and Nurminen stratified by age category. A conclusion of non-inferiority of V114 to PCV13 is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - PCV13) being \>-10 percentage points (1-sided p-value \<0.025).|Difference in Percent|-1.8|||<|0.001|TWO_SIDED|95.0|-4.0|-0.2|||Miettinen and Nurminen|||Serotype 23F: Participants With IgG ≥0.35 μg/mL||-0.2|-4.0|< 0.001
72339092|NCT04384107|144201822|NON_INFERIORITY|The stratum-adjusted proportion difference using the Cochran-Mantel-Haenszel weight, and the corresponding 95% CI and p-value based on the method of Miettinen and Nurminen stratified by age category. A conclusion of non-inferiority of V114 to PCV13 is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - PCV13) being \>-10 percentage points (1-sided p-value \<0.025).|Difference in Percent|2.0|||<|0.001|TWO_SIDED|95.0|0.4|4.3|||Miettinen and Nurminen|||Serotype 22F: Participants With IgG ≥0.35 μg/mL||4.3|0.4|<0.001
72339093|NCT04384107|144201822|NON_INFERIORITY|The stratum-adjusted proportion difference using the Cochran-Mantel-Haenszel weight, and the corresponding 95% CI and p-value based on the method of Miettinen and Nurminen stratified by age category. A conclusion of non-inferiority of V114 to PCV13 is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - PCV13) being \>-10 percentage points (1-sided p-value \<0.025).|Difference in Percent|-6.8|||=|0.048|TWO_SIDED|95.0|-10.6|-3.5|||Miettinen and Nurminen|||Serotype 33F: Participants With IgG ≥0.35 μg/mL||-3.5|-10.6|= 0.048
72339094|NCT04384107|144201823|NON_INFERIORITY|Based on a linear model with natural log-transformed IgG concentrations as response variable, and vaccination group and age category as factors. A conclusion of non-inferiority of V114 to PCV13 is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/PCV13) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio|0.61|||<|0.001|TWO_SIDED|95.0|0.55|0.67|||Linear model|||Serotype 1: IgG GMC Ratio||0.67|0.55|< 0.001
72339095|NCT04384107|144201823|NON_INFERIORITY|Based on a linear model with natural log-transformed IgG concentrations as response variable, and vaccination group and age category as factors. A conclusion of non-inferiority of V114 to PCV13 is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/PCV13) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio|1.85|||<|0.001|TWO_SIDED|95.0|1.67|2.05|||Linear model|||Serotype 3: IgG GMC Ratio||2.05|1.67|< 0.001
72339096|NCT04384107|144201823|NON_INFERIORITY|Based on a linear model with natural log-transformed IgG concentrations as response variable, and vaccination group and age category as factors. A conclusion of non-inferiority of V114 to PCV13 is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/PCV13) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio|0.84|||<|0.001|TWO_SIDED|95.0|0.76|0.93|||Linear model|||Serotype 4: IgG GMC Ratio||0.93|0.76|< 0.001
72339097|NCT04384107|144201823|NON_INFERIORITY|Based on a linear model with natural log-transformed IgG concentrations as response variable, and vaccination group and age category as factors. A conclusion of non-inferiority of V114 to PCV13 is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/PCV13) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio|0.77|||<|0.001|TWO_SIDED|95.0|0.69|0.87|||Linear model|||Serotype 5: IgG GMC Ratio||0.87|0.69|< 0.001
72339098|NCT04384107|144201823|NON_INFERIORITY|Based on a linear model with natural log-transformed IgG concentrations as response variable, and vaccination group and age category as factors. A conclusion of non-inferiority of V114 to PCV13 is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/PCV13) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio|0.56|||=|0.019|TWO_SIDED|95.0|0.5|0.63|||Linear model|||Serotype 6A: IgG GMC Ratio||0.63|0.50|= 0.019
72339099|NCT04384107|144201823|NON_INFERIORITY|Based on a linear model with natural log-transformed IgG concentrations as response variable, and vaccination group and age category as factors. A conclusion of non-inferiority of V114 to PCV13 is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/PCV13) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio|0.59|||=|0.015|TWO_SIDED|95.0|0.51|0.68|||Linear model|||Serotype 6B: IgG GMC Ratio||0.68|0.51|= 0.015
72339100|NCT04384107|144201823|NON_INFERIORITY|Based on a linear model with natural log-transformed IgG concentrations as response variable, and vaccination group and age category as factors. A conclusion of non-inferiority of V114 to PCV13 is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/PCV13) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio|0.84|||<|0.001|TWO_SIDED|95.0|0.75|0.94|||Linear model|||Serotype 7F: IgG GMC Ratio||0.94|0.75|< 0.001
72339101|NCT04384107|144201823|NON_INFERIORITY|Based on a linear model with natural log-transformed IgG concentrations as response variable, and vaccination group and age category as factors. A conclusion of non-inferiority of V114 to PCV13 is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/PCV13) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio|0.87|||<|0.001|TWO_SIDED|95.0|0.78|0.97|||Linear model|||Serotype 9V: IgG GMC Ratio||0.97|0.78|< 0.001
72339102|NCT04384107|144201823|NON_INFERIORITY|Based on a linear model with natural log-transformed IgG concentrations as response variable, and vaccination group and age category as factors. A conclusion of non-inferiority of V114 to PCV13 is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/PCV13) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio|0.75|||<|0.001|TWO_SIDED|95.0|0.66|0.85|||Linear model|||Serotype 14: IgG GMC Ratio||0.85|0.66|< 0.001
72339103|NCT04384107|144201823|NON_INFERIORITY|Based on a linear model with natural log-transformed IgG concentrations as response variable, and vaccination group and age category as factors. A conclusion of non-inferiority of V114 to PCV13 is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/PCV13) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio|0.74|||<|0.001|TWO_SIDED|95.0|0.67|0.82|||Linear model|||Serotype 18C: IgG GMC Ratio||0.82|0.67|< 0.001
72339104|NCT04384107|144201823|NON_INFERIORITY|Based on a linear model with natural log-transformed IgG concentrations as response variable, and vaccination group and age category as factors. A conclusion of non-inferiority of V114 to PCV13 is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/PCV13) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio|0.65|||<|0.001|TWO_SIDED|95.0|0.59|0.72|||Linear model|||Serotype 19A: IgG GMC Ratio||0.72|0.59|< 0.001
72339105|NCT04384107|144201823|NON_INFERIORITY|Based on a linear model with natural log-transformed IgG concentrations as response variable, and vaccination group and age category as factors. A conclusion of non-inferiority of V114 to PCV13 is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/PCV13) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio|0.75|||<|0.001|TWO_SIDED|95.0|0.69|0.82|||Linear model|||Serotype 19F: IgG GMC Ratio||0.82|0.69|< 0.001
72339106|NCT04384107|144201824|OTHER|Based on a linear model with natural log-transformed IgG concentrations as response variable, and vaccination group and age category as factors.|GMC Ratio|107.45|||||TWO_SIDED|95.0|96.18|120.03||||||Serotype 22F: IgG GMC Ratio||120.03|96.18|
72339107|NCT04384107|144201824|OTHER|Based on a linear model with natural log-transformed IgG concentrations as response variable, and vaccination group and age category as factors.|GMC Ratio|32.48|||||TWO_SIDED|95.0|27.72|38.05||||||Serotype 33F: IgG GMC Ratio||38.05|27.72|
72339108|NCT04384107|144201825|OTHER|The stratum-adjusted proportion difference using the Cochran-Mantel-Haenszel weight, and the corresponding 95% CI based on the method of Miettinen and Nurminen stratified by age category.|Difference in Percent|-0.3|||||TWO_SIDED|95.0|-1.7|0.8||||||Serotype 1: Participants With IgG ≥0.35 μg/mL||0.8|-1.7|
72339109|NCT04384107|144201825|OTHER|The stratum-adjusted proportion difference using the Cochran-Mantel-Haenszel weight, and the corresponding 95% CI based on the method of Miettinen and Nurminen stratified by age category.|Difference in Percent|3.3|||||TWO_SIDED|95.0|1.8|5.8||||||Serotype 3: Participants With IgG ≥0.35 μg/mL||5.8|1.8|
72339110|NCT04384107|144201825|OTHER|The stratum-adjusted proportion difference using the Cochran-Mantel-Haenszel weight, and the corresponding 95% CI based on the method of Miettinen and Nurminen stratified by age category.|Difference in Percent|-0.3|||||TWO_SIDED|95.0|-1.7|0.8||||||Serotype 4: Participants With IgG ≥0.35 μg/mL||0.8|-1.7|
72339111|NCT04384107|144201825|OTHER|The stratum-adjusted proportion difference using the Cochran-Mantel-Haenszel weight, and the corresponding 95% CI based on the method of Miettinen and Nurminen stratified by age category.|Difference in Percent|0.0|||||TWO_SIDED|95.0|-1.1|1.1||||||Serotype 5: Participants With IgG ≥0.35 μg/mL||1.1|-1.1|
72339112|NCT04384107|144201825|OTHER|The stratum-adjusted proportion difference using the Cochran-Mantel-Haenszel weight, and the corresponding 95% CI based on the method of Miettinen and Nurminen stratified by age category.|Difference in Percent|0.0|||||TWO_SIDED|95.0|-1.1|1.1||||||Serotype 6A: Participants With IgG ≥0.35 μg/mL||1.1|-1.1|
72339113|NCT04384107|144201825|OTHER|The stratum-adjusted proportion difference using the Cochran-Mantel-Haenszel weight, and the corresponding 95% CI based on the method of Miettinen and Nurminen stratified by age category.|Difference in Percent|0.0|||||TWO_SIDED|95.0|-1.1|1.1||||||Serotype 6B: Participants With IgG ≥0.35 μg/mL||1.1|-1.1|
72339114|NCT04384107|144201825|OTHER|The stratum-adjusted proportion difference using the Cochran-Mantel-Haenszel weight, and the corresponding 95% CI based on the method of Miettinen and Nurminen stratified by age category.|Difference in Percent|0.0|||||TWO_SIDED|95.0|-1.1|1.1||||||Serotype 7F: Participants With IgG ≥0.35 μg/mL||1.1|-1.1|
72339115|NCT04384107|144201825|OTHER|The stratum-adjusted proportion difference using the Cochran-Mantel-Haenszel weight, and the corresponding 95% CI based on the method of Miettinen and Nurminen stratified by age category.|Difference in Percent|0.0|||||TWO_SIDED|95.0|-1.1|1.1||||||Serotype 9V: Participants With IgG ≥0.35 μg/mL||1.1|-1.1|
72428326|NCT02471404|144367544|NON_INFERIORITY|The non-inferiority (NI) margin was determined to be 0.30% (in absolute terms). A difference of ≤0.30%, in HbA1c change from b/l to wk 52 between the treatment groups was considered clinically equivalent. NI was assessed using the 2-sided 95% Confidence Interval of adjusted mean difference between dapagliflozin or dapagliflozin plus saxagliptin and glimepiride.|Mean Difference (Final Values)|-0.21||||0.001|TWO_SIDED|95.0|-0.3443|-0.0825||(superiority)|Mixed Models Analysis|||||-0.0825|-0.3443|0.001
72428327|NCT02471404|144367545|SUPERIORITY||Risk Difference (RD)|-4.21|STANDARD_ERROR_OF_MEAN|1.14|<|0.001|TWO_SIDED|95.0|-6.45|-1.97|||Fisher Exact|||||-1.97|-6.45|<0.001
72428328|NCT02471404|144367545|SUPERIORITY||Risk Difference (RD)|-3.89|STANDARD_ERROR_OF_MEAN|1.19|<|0.001|TWO_SIDED|95.0|-6.21|-1.56|||Fisher Exact|||||-1.56|-6.21|<0.001
72428329|NCT02471404|144367546|SUPERIORITY||Mean Difference (Final Values)|-5.3|||<|0.001|TWO_SIDED|95.0|-5.93|-4.67|||Mixed Models Analysis|||||-4.67|-5.93|<0.001
72428330|NCT02471404|144367546|SUPERIORITY||Mean Difference (Final Values)|-4.91|||<|0.001|TWO_SIDED|95.0|-5.52|-4.29|||Mixed Models Analysis|||||-4.29|-5.52|<0.001
72428331|NCT02471404|144367547|SUPERIORITY||Mean Difference (Final Values)|-0.13||||0.374|TWO_SIDED|95.0|-0.43|0.16|||Mixed Models Analysis|||||0.16|-0.43|0.374
72428332|NCT02471404|144367547|SUPERIORITY||Mean Difference (Final Values)|-0.59|||<|0.001|TWO_SIDED|95.0|-0.88|-0.31|||Mixed Models Analysis|||||-0.31|-0.88|<0.001
72428333|NCT02471404|144367548|SUPERIORITY||Hazard Ratio (HR)|0.95||||0.777|TWO_SIDED|95.0|0.67|1.35|||Regression, Cox|||||1.35|0.67|0.777
72428334|NCT02471404|144367548|SUPERIORITY||Hazard Ratio (HR)|0.36|||<|0.001|TWO_SIDED|95.0|0.23|0.57|||Regression, Cox|||||0.57|0.23|<0.001
72428335|NCT00305864|144367551|SUPERIORITY_OR_OTHER|||||||0.27||95.0|||||Log Rank|One-sided||A one-sided one-sample log-rank test at significance level of 0.10 was predicted to have 85% power to detect a survival difference against the historical control (13.7 vs. 18.5 months) with 60 deaths.||||0.27
72428336|NCT00507026|144367555|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
72428337|NCT00507026|144367555|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
72428338|NCT00507026|144367556|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
72428339|NCT00507026|144367556|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
72428340|NCT00507026|144367557|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
72428341|NCT00507026|144367557|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
72428342|NCT00507026|144367558|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
72428343|NCT00507026|144367558|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
72428344|NCT00507026|144367559|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
72428345|NCT00507026|144367559|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
72428346|NCT02611830|144367642|SUPERIORITY||Risk Difference (RD)|32.3|||<|0.001|TWO_SIDED|95.0|19.7|45.0||P-value was calculated by Cochran-Mantel-Haenszel (CMH) test stratified by randomization strata according to concomitant use of corticosteroids, clinical remission status at Week 6, and previous TNF-α antagonist failure/concomitant immunomodulator.|Cochran-Mantel-Haenszel|||||45.0|19.7|<0.001
72428347|NCT02611830|144367643|SUPERIORITY||Risk Difference (RD)|35.7|||<|0.001|TWO_SIDED|95.0|22.1|49.3||P-value was calculated by CMH test stratified by randomization strata according to concomitant use of corticosteroids, clinical remission status at Week 6, and previous TNF-α antagonist failure/concomitant immunomodulator.|Cochran-Mantel-Haenszel|||||49.3|22.1|<0.001
72428348|NCT02611830|144367644|SUPERIORITY||Risk Difference (RD)|36.1|||<|0.001|TWO_SIDED|95.0|21.2|50.9||P-value was calculated by CMH test stratified by randomization strata according to concomitant use of corticosteroids, clinical remission status at Week 6, and previous TNF-α antagonist failure/concomitant immunomodulator.|Cochran-Mantel-Haenszel|||||50.9|21.2|<0.001
72428349|NCT02611830|144367645|SUPERIORITY||Risk Difference (RD)|9.7||||0.076|TWO_SIDED|95.0|-6.6|25.7||P-value was calculated by Fisher's Exact Test.|Fisher Exact|||||25.7|-6.6|0.076
72428350|NCT02611830|144367646|SUPERIORITY||Risk Difference (RD)|20.6||||0.067|TWO_SIDED|95.0|-4.5|43.7||P-value was calculated by Fisher's Exact Test.|Fisher Exact|||||43.7|-4.5|0.067
72428351|NCT00619476|144367706|SUPERIORITY_OR_OTHER||Adjusted Mean difference versus placebo|-0.81||||0.013|TWO_SIDED|95.0|-1.4|-0.23||This p-value has been adjusted for multiplicity using a step-down procedure that uses Dunnett's test within a closed testing scheme for multiple comparisons with a common control in order to maintain the overall experiment-wise alpha level of 0.05.|ANCOVA|An ANCOVA model with body mass index (BMI), baseline 24-hour average pain intensity, and grouped center as covariates was used.||||-0.23|-1.40|0.013
72428352|NCT00619476|144367706|SUPERIORITY_OR_OTHER||Adjusted Mean difference versus placebo|-0.7||||0.029|TWO_SIDED|95.0|-1.33|-0.07||This p-value has been adjusted for multiplicity using a step-down procedure that uses Dunnett's test within a closed testing scheme for multiple comparisons with a common control in order to maintain the overall experiment-wise alpha level of 0.05.|ANCOVA|An ANCOVA model with body mass index (BMI), baseline 24-hour average pain intensity, and grouped center as covariates was used.||||-0.07|-1.33|0.029
72428353|NCT00619476|144367706|SUPERIORITY_OR_OTHER||Adjusted Mean difference versus placebo|-1.07||||0.002|TWO_SIDED|95.0|-1.68|-0.45||This p-value has been adjusted for multiplicity using a step-down procedure that uses Dunnett's test within a closed testing scheme for multiple comparisons with a common control in order to maintain the overall experiment-wise alpha level of 0.05.|ANCOVA|An ANCOVA model with body mass index (BMI), baseline 24-hour average pain intensity, and grouped center as covariates was used.||||-0.45|-1.68|0.002
72428354|NCT01811563|144367725|EQUIVALENCE|Main effect for implant independent of time||||||0.661|||||||ANOVA|||||||0.661
72428355|NCT01811563|144367725|EQUIVALENCE|Main effect for time independent of implant|||||<|0.001|||||||ANOVA|||||||<0.001
72428356|NCT01811563|144367725|EQUIVALENCE|Interaction between implant and time||||||0.27|||||||ANOVA|||||||0.270
72428357|NCT01811563|144367726|EQUIVALENCE|Main effect for implant independent of time||||||0.856|||||||ANOVA|Main effect for implant, LQ-YBT Baseline to 52 weeks||||||0.856
72428358|NCT01811563|144367726|EQUIVALENCE|Time independent of implant, Baseline to 52 Weeks|||||<|0.001|||||||ANOVA|||||||<0.001
72428359|NCT01811563|144367726|EQUIVALENCE|Implant by Time interaction, Baseline to 52 Weeks between Zimmer and Stryker||||||0.822|||||||ANOVA|||||||0.822
72428360|NCT01811563|144367727|EQUIVALENCE|Main effect for implant, Baseline to 52 weeks||||||0.158|||||||ANOVA|||||||.158
72428361|NCT01811563|144367727|EQUIVALENCE|Main effect for time, Baseline to 52 weeks|||||<|0.001|||||||ANOVA|||||||<0.001
72339116|NCT04384107|144201825|OTHER|The stratum-adjusted proportion difference using the Cochran-Mantel-Haenszel weight, and the corresponding 95% CI based on the method of Miettinen and Nurminen stratified by age category.|Difference in Percent|0.0|||||TWO_SIDED|95.0|-1.1|1.1||||||Serotype 14: Participants With IgG ≥0.35 μg/mL||1.1|-1.1|
72339117|NCT04384107|144201825|OTHER|The stratum-adjusted proportion difference using the Cochran-Mantel-Haenszel weight, and the corresponding 95% CI based on the method of Miettinen and Nurminen stratified by age category.|Difference in Percent|0.0|||||TWO_SIDED|95.0|-1.1|1.1||||||Serotype 18C: Participants With IgG ≥0.35 μg/mL||1.1|-1.1|
72339118|NCT04384107|144201825|OTHER|The stratum-adjusted proportion difference using the Cochran-Mantel-Haenszel weight, and the corresponding 95% CI based on the method of Miettinen and Nurminen stratified by age category.|Difference in Percent|0.0|||||TWO_SIDED|95.0|-1.1|1.1||||||Serotype 19A: Participants With IgG ≥0.35 μg/mL||1.1|-1.1|
72339119|NCT04384107|144201825|OTHER|The stratum-adjusted proportion difference using the Cochran-Mantel-Haenszel weight, and the corresponding 95% CI based on the method of Miettinen and Nurminen stratified by age category.|Difference in Percent|0.0|||||TWO_SIDED|95.0|-1.1|1.1||||||Serotype 19F: Participants With IgG ≥0.35 μg/mL||1.1|-1.1|
72339120|NCT04384107|144201825|OTHER|The stratum-adjusted proportion difference using the Cochran-Mantel-Haenszel weight, and the corresponding 95% CI based on the method of Miettinen and Nurminen stratified by age category.|Difference in Percent|0.3|||||TWO_SIDED|95.0|-1.1|1.9||||||Serotype 23F: Participants With IgG ≥0.35 μg/mL||1.9|-1.1|
72339121|NCT04384107|144201825|OTHER|The stratum-adjusted proportion difference using the Cochran-Mantel-Haenszel weight, and the corresponding 95% CI based on the method of Miettinen and Nurminen stratified by age category.|Difference in Percent|94.8|||||TWO_SIDED|95.0|91.8|96.7||||||Serotype 22F: Participants With IgG ≥0.35 μg/mL||96.7|91.8|
72339122|NCT04384107|144201825|OTHER|The stratum-adjusted proportion difference using the Cochran-Mantel-Haenszel weight, and the corresponding 95% CI based on the method of Miettinen and Nurminen stratified by age category.|Difference in Percent|88.5|||||TWO_SIDED|95.0|84.5|91.6||||||Serotype 33F: Participants With IgG ≥0.35 μg/mL||91.6|84.5|
72339123|NCT04384107|144201826|OTHER|Based on a linear model with natural log-transformed IgG concentrations as response variable, and vaccination group and age category as factors.|GMC Ratio|0.53|||||TWO_SIDED|95.0|0.47|0.59||||||Serotype 1: IgG GMC Ratio||0.59|0.47|
72339124|NCT04384107|144201826|OTHER|Based on a linear model with natural log-transformed IgG concentrations as response variable, and vaccination group and age category as factors.|GMC Ratio|1.71|||||TWO_SIDED|95.0|1.53|1.9||||||Serotype 3: IgG GMC Ratio||1.90|1.53|
72339125|NCT04384107|144201826|OTHER|Based on a linear model with natural log-transformed IgG concentrations as response variable, and vaccination group and age category as factors.|GMC Ratio|0.92|||||TWO_SIDED|95.0|0.8|1.05||||||Serotype 4: IgG GMC Ratio||1.05|0.80|
72339126|NCT04384107|144201826|OTHER|Based on a linear model with natural log-transformed IgG concentrations as response variable, and vaccination group and age category as factors.|GMC Ratio|0.67|||||TWO_SIDED|95.0|0.59|0.75||||||Serotype 5: IgG GMC Ratio||0.75|0.59|
72339127|NCT04384107|144201826|OTHER|Based on a linear model with natural log-transformed IgG concentrations as response variable, and vaccination group and age category as factors.|GMC Ratio|0.64|||||TWO_SIDED|95.0|0.56|0.73||||||Serotype 6A: IgG GMC Ratio||0.73|0.56|
72339128|NCT04384107|144201826|OTHER|Based on a linear model with natural log-transformed IgG concentrations as response variable, and vaccination group and age category as factors.|GMC Ratio|0.74|||||TWO_SIDED|95.0|0.65|0.84||||||Serotype 6B: IgG GMC Ratio||0.84|0.65|
72339129|NCT04384107|144201826|OTHER|Based on a linear model with natural log-transformed IgG concentrations as response variable, and vaccination group and age category as factors.|GMC Ratio|0.81|||||TWO_SIDED|95.0|0.71|0.92||||||Serotype 7F: IgG GMC Ratio||0.92|0.71|
72339130|NCT04384107|144201826|OTHER|Based on a linear model with natural log-transformed IgG concentrations as response variable, and vaccination group and age category as factors.|GMC Ratio|0.83|||||TWO_SIDED|95.0|0.73|0.94||||||Serotype 9V: IgG GMC Ratio||0.94|0.73|
72339131|NCT04384107|144201826|OTHER|Based on a linear model with natural log-transformed IgG concentrations as response variable, and vaccination group and age category as factors.|GMC Ratio|0.84|||||TWO_SIDED|95.0|0.74|0.96||||||Serotype 14: IgG GMC Ratio||0.96|0.74|
72339132|NCT04384107|144201826|OTHER|Based on a linear model with natural log-transformed IgG concentrations as response variable, and vaccination group and age category as factors.|GMC Ratio|1.0|||||TWO_SIDED|95.0|0.87|1.14||||||Serotype 18C: IgG GMC Ratio||1.14|0.87|
72339133|NCT04384107|144201826|OTHER|Based on a linear model with natural log-transformed IgG concentrations as response variable, and vaccination group and age category as factors.|GMC Ratio|0.82|||||TWO_SIDED|95.0|0.73|0.92||||||Serotype 19A: IgG GMC Ratio||0.92|0.73|
72339134|NCT04384107|144201826|OTHER|Based on a linear model with natural log-transformed IgG concentrations as response variable, and vaccination group and age category as factors.|GMC Ratio|0.84|||||TWO_SIDED|95.0|0.75|0.94||||||Serotype 19F: IgG GMC Ratio||0.94|0.75|
72339135|NCT04384107|144201826|OTHER|Based on a linear model with natural log-transformed IgG concentrations as response variable, and vaccination group and age category as factors.|GMC Ratio|0.6|||||TWO_SIDED|95.0|0.52|0.7||||||Serotype 23F: IgG GMC Ratio||0.70|0.52|
72339136|NCT04384107|144201826|OTHER|Based on a linear model with natural log-transformed IgG concentrations as response variable, and vaccination group and age category as factors.|GMC Ratio|86.74|||||TWO_SIDED|95.0|77.61|96.95||||||Serotype 22F: IgG GMC Ratio||96.95|77.61|
72339137|NCT04384107|144201826|OTHER|Based on a linear model with natural log-transformed IgG concentrations as response variable, and vaccination group and age category as factors.|GMC Ratio|45.44|||||TWO_SIDED|95.0|40.07|51.54||||||Serotype 33F: IgG GMC Ratio||51.54|40.07|
72339138|NCT04384107|144201827|OTHER|Based on a linear model with natural log-transformed OPA titers as response variable, and vaccination group and age category as factors.|GMT Ratio|0.66|||||TWO_SIDED|95.0|0.55|0.78||||||Serotype 1: OPA GMT Ratio||0.78|0.55|
72339139|NCT04384107|144201827|OTHER|Based on a linear model with natural log-transformed OPA titers as response variable, and vaccination group and age category as factors.|GMT Ratio|1.4|||||TWO_SIDED|95.0|1.23|1.59||||||Serotype 3: OPA GMT Ratio||1.59|1.23|
72339140|NCT04384107|144201827|OTHER|Based on a linear model with natural log-transformed OPA titers as response variable, and vaccination group and age category as factors.|GMT Ratio|0.97|||||TWO_SIDED|95.0|0.85|1.1||||||Serotype 4: OPA GMT Ratio||1.10|0.85|
72339141|NCT04384107|144201827|OTHER|Based on a linear model with natural log-transformed OPA titers as response variable, and vaccination group and age category as factors.|GMT Ratio|0.91|||||TWO_SIDED|95.0|0.8|1.04||||||Serotype 5: OPA GMT Ratio||1.04|0.80|
72339142|NCT04384107|144201827|OTHER|Based on a linear model with natural log-transformed OPA titers as response variable, and vaccination group and age category as factors.|GMT Ratio|0.76|||||TWO_SIDED|95.0|0.65|0.89||||||Serotype 6A: OPA GMT Ratio||0.89|0.65|
72339143|NCT04384107|144201827|OTHER|Based on a linear model with natural log-transformed OPA titers as response variable, and vaccination group and age category as factors.|GMC Ratio|0.81|||||TWO_SIDED|95.0|0.69|0.95||||||Serotype 6B: OPA GMT Ratio||0.95|0.69|
72339144|NCT04384107|144201827|OTHER|Based on a linear model with natural log-transformed OPA titers as response variable, and vaccination group and age category as factors.|GMC Ratio|0.81|||||TWO_SIDED|95.0|0.7|0.95||||||Serotype 7F: OPA GMT Ratio||0.95|0.70|
72339145|NCT04384107|144201827|OTHER|Based on a linear model with natural log-transformed OPA titers as response variable, and vaccination group and age category as factors.|GMT Ratio|0.82|||||TWO_SIDED|95.0|0.71|0.94||||||Serotype 9V: OPA GMT Ratio||0.94|0.71|
72339146|NCT04384107|144201827|OTHER|Based on a linear model with natural log-transformed OPA titers as response variable, and vaccination group and age category as factors.|GMT Ratio|1.15|||||TWO_SIDED|95.0|0.97|1.38||||||Serotype 14: OPA GMT Ratio||1.38|0.97|
72339147|NCT04384107|144201827|OTHER|Based on a linear model with natural log-transformed OPA titers as response variable, and vaccination group and age category as factors.|GMT Ratio|1.0|||||TWO_SIDED|95.0|0.9|1.11||||||Serotype 18C: OPA GMT Ratio||1.11|0.90|
72339148|NCT04384107|144201827|OTHER|Based on a linear model with natural log-transformed OPA titers as response variable, and vaccination group and age category as factors.|GMT Ratio|0.68|||||TWO_SIDED|95.0|0.61|0.77||||||Serotype 19A: OPA GMT Ratio||0.77|0.61|
72339149|NCT04384107|144201827|OTHER|Based on a linear model with natural log-transformed OPA titers as response variable, and vaccination group and age category as factors.|GMT Ratio|0.93|||||TWO_SIDED|95.0|0.84|1.04||||||Serotype 19F: OPA GMT Ratio||1.04|0.84|
72339150|NCT04384107|144201827|OTHER|Based on a linear model with natural log-transformed OPA titers as response variable, and vaccination group and age category as factors.|GMT Ratio|0.63|||||TWO_SIDED|95.0|0.53|0.74||||||Serotype 23F: OPA GMT Ratio||0.74|0.53|
72339151|NCT04384107|144201827|OTHER|Based on a linear model with natural log-transformed OPA titers as response variable, and vaccination group and age category as factors.|GMT Ratio|560.46|||||TWO_SIDED|95.0|474.05|662.63||||||Serotype 22F: OPA GMT Ratio||662.63|474.05|
72339152|NCT04384107|144201827|OTHER|Based on a linear model with natural log-transformed OPA titers as response variable, and vaccination group and age category as factors.|GMT Ratio|196.14|||||TWO_SIDED|95.0|141.85|271.21||||||Serotype 33F: OPA GMT Ratio||271.21|141.85|
72339153|NCT04384107|144201828|OTHER|Based on a linear model with natural log-transformed OPA titers as response variable, and vaccination group and age category as factors.|GMT Ratio|0.53|||||TWO_SIDED|95.0|0.38|0.75||||||Serotype 1: OPA GMT Ratio||0.75|0.38|
72339154|NCT04384107|144201828|OTHER|Based on a linear model with natural log-transformed OPA titers as response variable, and vaccination group and age category as factors.|GMT Ratio|1.62|||||TWO_SIDED|95.0|1.28|2.03||||||Serotype 3: OPA GMT Ratio||2.03|1.28|
72339155|NCT04384107|144201828|OTHER|Based on a linear model with natural log-transformed OPA titers as response variable, and vaccination group and age category as factors.|GMT Ratio|0.72|||||TWO_SIDED|95.0|0.57|0.93||||||Serotype 4: OPA GMT Ratio||0.93|0.57|
72339156|NCT04384107|144201828|OTHER|Based on a linear model with natural log-transformed OPA titers as response variable, and vaccination group and age category as factors.|GMT Ratio|0.86|||||TWO_SIDED|95.0|0.66|1.13||||||Serotype 5: OPA GMT Ratio||1.13|0.66|
72339157|NCT04384107|144201828|OTHER|Based on a linear model with natural log-transformed OPA titers as response variable, and vaccination group and age category as factors.|GMT Ratio|0.72|||||TWO_SIDED|95.0|0.57|0.91||||||Serotype 6A: OPA GMT Ratio||0.91|0.57|
72339158|NCT04384107|144201828|OTHER|Based on a linear model with natural log-transformed OPA titers as response variable, and vaccination group and age category as factors.|GMT Ratio|0.66|||||TWO_SIDED|95.0|0.52|0.83||||||Serotype 6B: OPA GMT Ratio||0.83|0.52|
72339159|NCT04384107|144201828|OTHER|Based on a linear model with natural log-transformed OPA titers as response variable, and vaccination group and age category as factors.|GMT Ratio|0.86|||||TWO_SIDED|95.0|0.68|1.07||||||Serotype 7F: OPA GMT Ratio||1.07|0.68|
72339160|NCT04384107|144201828|OTHER|Based on a linear model with natural log-transformed OPA titers as response variable, and vaccination group and age category as factors.|GMT Ratio|0.65|||||TWO_SIDED|95.0|0.5|0.84||||||Serotype 9V: OPA GMT Ratio||0.84|0.50|
72339161|NCT04384107|144201828|OTHER|Based on a linear model with natural log-transformed OPA titers as response variable, and vaccination group and age category as factors.|GMT Ratio|1.48|||||TWO_SIDED|95.0|1.16|1.9||||||Serotype 14: OPA GMT Ratio||1.90|1.16|
72339162|NCT04384107|144201828|OTHER|Based on a linear model with natural log-transformed OPA titers as response variable, and vaccination group and age category as factors.|GMT Ratio|1.19|||||TWO_SIDED|95.0|0.95|1.48||||||Serotype 18C: OPA GMT Ratio||1.48|0.95|
72339163|NCT04384107|144201828|OTHER|Based on a linear model with natural log-transformed OPA titers as response variable, and vaccination group and age category as factors.|GMT Ratio|0.78|||||TWO_SIDED|95.0|0.6|1.01||||||Serotype 19A: OPA GMT Ratio||1.01|0.60|
72339164|NCT04384107|144201828|OTHER|Based on a linear model with natural log-transformed OPA titers as response variable, and vaccination group and age category as factors.|GMT Ratio|1.23|||||TWO_SIDED|95.0|1.0|1.52||||||Serotype 19F: OPA GMT Ratio||1.52|1.00|
72339165|NCT04384107|144201828|OTHER|Based on a linear model with natural log-transformed OPA titers as response variable, and vaccination group and age category as factors.|GMT Ratio|0.37|||||TWO_SIDED|95.0|0.28|0.49||||||Serotype 23F: OPA GMT Ratio||0.49|0.28|
72339166|NCT04384107|144201828|OTHER|Based on a linear model with natural log-transformed OPA titers as response variable, and vaccination group and age category as factors.|GMT Ratio|155.88|||||TWO_SIDED|95.0|101.84|238.59||||||Serotype 22F: OPA GMT Ratio||238.59|101.84|
72339167|NCT04384107|144201828|OTHER|Based on a linear model with natural log-transformed OPA titers as response variable, and vaccination group and age category as factors.|GMT Ratio|16.81|||||TWO_SIDED|95.0|11.74|24.08||||||Serotype 33F: OPA GMT Ratio||24.08|11.74|
72339168|NCT00316524|144201840|NON_INFERIORITY|The non-inferiority margin to show that Group 4 (vaccinia experienced subjects receiving a single vaccination) is non-inferior to Group 1 (vaccinia naive subjects receiving 2 vaccinations) in terms of seroconversion rate 2 weeks after the last vaccination was predefined as -5% for the difference in seroconversion rates|Difference in seroconversion rates (%)|-3.4|||||ONE_SIDED|97.5|-7.36||||||||||-7.36|
72339169|NCT04948307|144201917|SUPERIORITY|||||||0.7326|||||||Chi-squared|||||||0.7326
72339170|NCT04948307|144201918|SUPERIORITY|||||||0.7396|||||||Kolmogorov-Smirnoff|||||||0.7396
72339171|NCT04948307|144201919|SUPERIORITY|||||||0.871|||||||Kolmogorov-Smirnoff|||||||0.8710
72339172|NCT04948307|144201920|SUPERIORITY|||||||0.8816|||||||Kolmogorov-Smirnoff|||||||0.8816
72339173|NCT04948307|144201921|SUPERIORITY|||||||0.5281|||||||Chi-squared|||||||0.5281
72339174|NCT04948307|144201922|SUPERIORITY|||||||0.2996|||||||Chi-squared|||||||0.2996
72339175|NCT04948307|144201926|SUPERIORITY|||||||0.7201|||||||Kolmogorov-Smirnoff|||||||0.7201
72339176|NCT04948307|144201928|OTHER|||||||||||||||||Summary statistics are presented.|Summary statistics are presented|||
72339177|NCT04948307|144201930|OTHER||||||||||||||||||Summary statistics are presented.|||
72339178|NCT03710876|144201939|SUPERIORITY||Hazard Ratio (HR)|0.83||||0.284|TWO_SIDED|95.0|0.43|1.59||1-sided|Log Rank|||||1.59|0.43|0.2840
72339179|NCT03710876|144201941|SUPERIORITY||Risk Difference (RD)|2.9||||1|TWO_SIDED|95.0|-17.3|24.3||2-sided|Fisher Exact||Risk difference is proportion achieving objective response in r+C+G group minus the proportion achieving objective response in C+ G group. The confidence interval was calculated by the exact conditional method of Chan and Zhang.|||24.3|-17.3|1.0000
72339180|NCT03710876|144201942|SUPERIORITY||Risk Difference (RD)|2.2||||1|TWO_SIDED|95.0|-25.2|29.2|||Fisher Exact||Risk difference is proportion achieving response in r+C+G group minus the proportion achieving response in C+ G group. The confidence interval was calculated by the exact conditional method of Chan and Zhang.|||29.2|-25.2|1.0000
72339181|NCT03710876|144201943|SUPERIORITY||Risk Difference (RD)|-7.6||||0.7665|TWO_SIDED|95.0|-34.9|20.3|||Fisher Exact||Risk difference is proportion achieving response in r+C+G group minus the proportion achieving response in C+ G group. The confidence interval was calculated by the exact conditional method of Chan and Zhang.|||20.3|-34.9|0.7665
72339182|NCT03710876|144201944|SUPERIORITY||Risk Difference (RD)|-4.4||||0.7537|TWO_SIDED|95.0|-31.7|23.0||2-sided.|Chi-squared|Variance calculated by Greenwood's method.|Risk difference is estimated probability of survival in r+C+G minus the estimated probability of survival in C+G group.|Percentage proportion calculated by Kaplan-Meier method.||23.0|-31.7|0.7537
72339183|NCT03710876|144201945|SUPERIORITY||Risk Difference (RD)|18.4||||0.1855|TWO_SIDED|95.0|-8.8|45.6||2-sided|Chi-squared|Variance calculated by Greenwood's method|Risk difference is estimated probability of survival in r+C+G minus the estimated probability of survival in C+G group.|Percentage proportion calculated by Kaplan-Meier method.||45.6|-8.8|0.1855
72339184|NCT03710876|144201946|SUPERIORITY||Risk Difference (RD)|12.2||||0.357|TWO_SIDED|95.0|-13.8|38.3||2-sided|Chi-squared|Variance calculated by Greenwood's method|Risk difference is estimated probability of survival in r+C+G minus the estimated probability of survival in C+G group.|Percentage proportion calculated by Kaplan-Meier method.||38.3|-13.8|0.3570
72339185|NCT03710876|144201947|SUPERIORITY||Risk Difference (RD)|13.5||||0.2856|TWO_SIDED|95.0|-11.3|38.3||2-sided|Chi-squared|Variance calculated by Greenwood's method.|Risk difference is estimated probability of survival in r+C+G minus the estimated probability of survival in C+G group.|Percentage proportion calculated by Kaplan-Meier method.||38.3|-11.3|0.2856
72339186|NCT03710876|144201948|SUPERIORITY||Risk Difference (RD)|6.1||||0.6173|TWO_SIDED|95.0|-17.8|30.0||2-sided|Chi-squared|Variance calculated by Greenwood's method.|Risk difference is estimated probability of survival in r+C+G minus the estimated probability of survival in C+G group.|Percentage proportion calculated by Kaplan-Meier method.||30.0|-17.8|0.6173
72339187|NCT03710876|144201949|SUPERIORITY||Risk Difference (RD)|6.1||||0.6173|TWO_SIDED|95.0|-17.8|30.0||2-sided|Chi-squared|Variance calculated by Greenwood's method.|Risk difference is estimated probability of survival in r+C+G minus the estimated probability of survival in C+G group.|Percentage proportion calculated by Kaplan-Meier method.||30.0|-17.8|0.6173
72339188|NCT02262078|144201991|SUPERIORITY_OR_OTHER|||||||0.002|||||||t-test, 2 sided|||||||0.002
72339189|NCT00098722|144201998|SUPERIORITY_OR_OTHER||LS mean difference|-1.021|STANDARD_ERROR_OF_MEAN|0.1802|||TWO_SIDED|97.5|-1.426|-0.616||||||The difference between the treatment least square means (LS means) adjusted for randomization strata was presented in addition to 2-sided 97.5% confidence interval (CI) as an adjustment for multiplicity using a Bonferroni correction. Negative value favors maraviroc over placebo.||-0.616|-1.426|
72339190|NCT00098722|144201998|SUPERIORITY_OR_OTHER||LS mean difference|-1.042|STANDARD_ERROR_OF_MEAN|0.1786|||TWO_SIDED|97.5|-1.444|-0.64||||||The difference between the treatment LS means adjusted for randomization strata was presented in addition to 2-sided 97.5% CI as an adjustment for multiplicity using a Bonferroni correction. Negative value favors maraviroc over placebo.||-0.640|-1.444|
72339191|NCT00098722|144201999|SUPERIORITY_OR_OTHER||LS mean difference|-0.961|STANDARD_ERROR_OF_MEAN|0.1856|||TWO_SIDED|97.5|-1.379|-0.544||||||The difference between the treatment LS means adjusted for randomization strata was presented in addition to 2-sided 97.5% CI as an adjustment for multiplicity using a Bonferroni correction. Negative value favors maraviroc over placebo.||-0.544|-1.379|
72339192|NCT00098722|144201999|SUPERIORITY_OR_OTHER||LS mean difference|-1.109|STANDARD_ERROR_OF_MEAN|0.184|||TWO_SIDED|97.5|-1.523|-0.695||||||The difference between the treatment LS means adjusted for randomization strata was presented in addition to 2-sided 97.5% CI as an adjustment for multiplicity using a Bonferroni correction. Negative value favors maraviroc over placebo.||-0.695|-1.523|
72339193|NCT00098722|144202000|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.59|||<|0.0001|TWO_SIDED|95.0|2.56|8.23|||Regression, Logistic|||Week 24: Two-sided 95% CI was presented for the odds ratios between treatment groups with placebo as the comparator. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (less than \[\<\] 100,000 or greater than or equal to \[\>=\] 100,000), enfuvirtide use (Yes or No) as covariates was used. Odds ratio greater than (\>) 1 favors maraviroc.||8.23|2.56|<0.0001
72339194|NCT00098722|144202000|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.01|||<|0.0001|TWO_SIDED|95.0|3.35|10.78|||Regression, Logistic|||Week 24: Two-sided 95% CI was presented for the odds ratios between treatment groups with placebo as the comparator. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (\<100,000 or \>=100,000), enfuvirtide use (Yes or No) as covariates was used. Odds ratio \>1 favors maraviroc.||10.78|3.35|<0.0001
72339195|NCT00098722|144202000|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.03|||<|0.0001|TWO_SIDED|95.0|2.25|7.2|||Regression, Logistic|||Week 48: Two-sided 95% CI was presented for the odds ratios between treatment groups with placebo as the comparator. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (\<100,000 or \>=100,000), enfuvirtide use (Yes or No) as covariates was used. Odds ratio \>1 favors maraviroc.||7.20|2.25|<0.0001
72339196|NCT00098722|144202000|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.41|||<|0.0001|TWO_SIDED|95.0|2.47|7.85|||Regression, Logistic|||Week 48: Two-sided 95% CI was presented for the odds ratios between treatment groups with placebo as the comparator. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (\<100,000 or \>=100,000), enfuvirtide use (Yes or No) as covariates was used. Odds ratio \>1 favors maraviroc.||7.85|2.47|<0.0001
72339197|NCT00098722|144202001|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.69|||<|0.0001|TWO_SIDED|95.0|2.72|8.1|||Regression, Logistic|||Week 24: Two-sided 95% CI was presented for the odds ratios between treatment groups with placebo as the comparator. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (\<100,000 or \>=100,000), enfuvirtide use (Yes or No) as covariates was used. Odds ratio \>1 favors maraviroc.||8.10|2.72|<0.0001
72339198|NCT00098722|144202001|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.01|||<|0.0001|TWO_SIDED|95.0|2.91|8.62|||Regression, Logistic|||Week 24: Two-sided 95% CI was presented for the odds ratios between treatment groups with placebo as the comparator. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (\<100,000 or \>=100,000), enfuvirtide use (Yes or No) as covariates was used. Odds ratio \>1 favors maraviroc.||8.62|2.91|<0.0001
72339199|NCT00098722|144202001|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.67|||<|0.0001|TWO_SIDED|95.0|2.13|6.32|||Regression, Logistic|||Week 48: Two-sided 95% CI was presented for the odds ratios between treatment groups with placebo as the comparator. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (\<100,000 or \>=100,000), enfuvirtide use (Yes or No) as covariates was used. Odds ratio \>1 favors maraviroc.||6.32|2.13|<0.0001
72339200|NCT00098722|144202001|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.64|||<|0.0001|TWO_SIDED|95.0|2.69|8.02|||Regression, Logistic|||Week 48: Two-sided 95% CI was presented for the odds ratios between treatment groups with placebo as the comparator. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (\<100,000 or \>=100,000), enfuvirtide use (Yes or No) as covariates was used. Odds ratio \>1 favors maraviroc.||8.02|2.69|<0.0001
72339201|NCT00098722|144202002|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.58|||<|0.0001|TWO_SIDED|95.0|2.64|7.92|||Regression, Logistic|||Week 24: Two-sided 95% CI was presented for the odds ratios between treatment groups with placebo as the comparator. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (\<100,000 or \>=100,000), enfuvirtide use (Yes or No) as covariates was used. Odds ratio \>1 favors maraviroc.||7.92|2.64|<0.0001
72339202|NCT00098722|144202002|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.42|||<|0.0001|TWO_SIDED|95.0|3.13|9.39|||Regression, Logistic|||Week 24: Two-sided 95% CI was presented for the odds ratios between treatment groups with placebo as the comparator. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (\<100,000 or \>=100,000), enfuvirtide use (Yes or No) as covariates was used. Odds ratio \>1 favors maraviroc.||9.39|3.13|<0.0001
72339203|NCT00098722|144202002|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.01|||<|0.0001|TWO_SIDED|95.0|2.29|7.0|||Regression, Logistic|||Week 48: Two-sided 95% CI was presented for the odds ratios between treatment groups with placebo as the comparator. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (\<100,000 or \>=100,000), enfuvirtide use (Yes or No) as covariates was used. Odds ratio \>1 favors maraviroc.||7.00|2.29|<0.0001
72339204|NCT00098722|144202002|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.08|||<|0.0001|TWO_SIDED|95.0|2.91|8.89|||Regression, Logistic|||Week 48: Two-sided 95% CI was presented for the odds ratios between treatment groups with placebo as the comparator. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (\<100,000 or \>=100,000), enfuvirtide use (Yes or No) as covariates was used. Odds ratio \>1 favors maraviroc.||8.89|2.91|<0.0001
72339205|NCT00098722|144202003|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.55|||<|0.0001|TWO_SIDED|95.0|1.95|6.48|||Regression, Logistic|||Week 24: Two-sided 95% CI was presented for the odds ratios between treatment groups with placebo as the comparator. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (\<100,000 or \>=100,000), enfuvirtide use (Yes or No) as covariates was used. Odds ratio \>1 favors maraviroc.||6.48|1.95|<0.0001
72339206|NCT00098722|144202003|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.88||||0.0005|TWO_SIDED|95.0|1.59|5.23|||Regression, Logistic|||Week 24: Two-sided 95% CI was presented for the odds ratios between treatment groups with placebo as the comparator. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (\<100,000 or \>=100,000), enfuvirtide use (Yes or No) as covariates was used. Odd ratio \>1 favors maraviroc.||5.23|1.59|0.0005
72339207|NCT00098722|144202003|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.23|||<|0.0001|TWO_SIDED|95.0|2.26|7.92|||Regression, Logistic|||Week 48: Two-sided 95% CI was presented for the odds ratios between treatment groups with placebo as the comparator. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (\<100,000 or \>=100,000), enfuvirtide use (Yes or No) as covariates was used. Odds ratio \>1 favors maraviroc.||7.92|2.26|<0.0001
72339208|NCT00098722|144202003|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.1|||<|0.0001|TWO_SIDED|95.0|2.2|7.64|||Regression, Logistic|||Week 48: Two-sided 95% CI was presented for the odds ratios between treatment groups with placebo as the comparator. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (\<100,000 or \>=100,000), enfuvirtide use (Yes or No) as covariates was used. Odds ratio \>1 favors maraviroc.||7.64|2.20|<0.0001
72339209|NCT00098722|144202005|SUPERIORITY_OR_OTHER||LS mean difference|47.94|STANDARD_ERROR_OF_MEAN|13.383|||TWO_SIDED|95.0|21.64|74.25||||||Week 24: The difference between the treatment LS means adjusted for the randomization strata was presented in addition to 2-sided 95% CI. Positive value favors maraviroc over placebo.||74.25|21.64|
72339210|NCT00098722|144202005|SUPERIORITY_OR_OTHER||LS mean difference|38.12|STANDARD_ERROR_OF_MEAN|13.313|||TWO_SIDED|95.0|11.96|64.28||||||Week 24: The difference between the treatment LS means adjusted for the randomization strata was presented in addition to 2-sided 95% CI. Positive value favors maraviroc over placebo.||64.28|11.96|
72339211|NCT00098722|144202005|SUPERIORITY_OR_OTHER||LS mean difference|52.15|STANDARD_ERROR_OF_MEAN|14.803|||TWO_SIDED|95.0|23.06|81.25||||||Week 48: The difference between the treatment LS means adjusted for the randomization strata was presented in addition to 2-sided 95% CI. Positive value favors maraviroc over placebo.||81.25|23.06|
72428362|NCT01811563|144367727|EQUIVALENCE|Interaction of time by implant, Baseline to 52 weeks||||||0.365|||||||ANOVA|||||||0.365
72339212|NCT00098722|144202005|SUPERIORITY_OR_OTHER||LS mean difference|58.46|STANDARD_ERROR_OF_MEAN|14.725|||TWO_SIDED|95.0|29.53|87.4||||||Week 48: The difference between the treatment LS means adjusted for the randomization strata was presented in addition to 2-sided 95% CI. Positive value favors maraviroc over placebo.||87.40|29.53|
72339213|NCT00098722|144202006|SUPERIORITY_OR_OTHER||LS mean difference|218.57|STANDARD_ERROR_OF_MEAN|71.225|||TWO_SIDED|95.0|78.59|358.54||||||Week 24: The difference between the treatment LS means adjusted for the randomization strata was presented in addition to 2-sided 95% CI. Positive value favors maraviroc over placebo.||358.54|78.59|
72339214|NCT00098722|144202006|SUPERIORITY_OR_OTHER||LS mean difference|133.22|STANDARD_ERROR_OF_MEAN|70.855|||TWO_SIDED|95.0|-6.03|272.47||||||Week 24: The difference between the treatment LS means adjusted for the randomization strata was presented in addition to 2-sided 95% CI. Positive value favors maraviroc over placebo.||272.47|-6.03|
72339215|NCT00098722|144202006|SUPERIORITY_OR_OTHER||LS mean difference|136.93|STANDARD_ERROR_OF_MEAN|57.85|||TWO_SIDED|95.0|23.24|250.62||||||Week 48: The difference between the treatment LS means adjusted for the randomization strata was presented in addition to 2-sided 95% CI. Positive value favors maraviroc over placebo.||250.62|23.24|
72339216|NCT00098722|144202006|SUPERIORITY_OR_OTHER||LS mean difference|140.25|STANDARD_ERROR_OF_MEAN|57.55|||TWO_SIDED|95.0|27.15|253.35||||||Week 48: The difference between the treatment LS means adjusted for the randomization strata was presented in addition to 2-sided 95% CI. Positive value favors maraviroc over placebo.||253.35|27.15|
72339217|NCT00098722|144202007|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.4|||<|0.0001|TWO_SIDED|95.0|0.29|0.56|||Log Rank|||P-value was calculated using Log rank test controlling for the effect of the randomization strata. Hazard ratio calculated by fitting a Cox proportional hazards model including treatment group and randomization strata. Hazard ratio \<1 favors maraviroc.||0.56|0.29|<0.0001
72339218|NCT00098722|144202007|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.33|||<|0.0001|TWO_SIDED|95.0|0.23|0.46|||Log Rank|||P-value was calculated using Log rank test controlling for the effect of the randomization strata. Hazard ratio calculated by fitting a Cox proportional hazards model including treatment group and randomization strata. Hazard ratio \<1 favors maraviroc.||0.46|0.23|<0.0001
72339219|NCT00098722|144202008|SUPERIORITY_OR_OTHER||LS mean difference|-0.876|STANDARD_ERROR_OF_MEAN|0.1534|||TWO_SIDED|95.0|-1.177|-0.575||||||Week 24: The difference between the treatment LS means adjusted for the randomization strata was presented in addition to 2-sided 95% CI. Negative value favors maraviroc over placebo.||-0.575|-1.177|
72339220|NCT00098722|144202008|SUPERIORITY_OR_OTHER||LS mean difference|-0.882|STANDARD_ERROR_OF_MEAN|0.1521|||TWO_SIDED|95.0|-1.181|-0.584||||||Week 24: The difference between the treatment LS means adjusted for the randomization strata was presented in addition to 2-sided 95% CI. Negative value favors maraviroc over placebo.||-0.584|-1.181|
72339221|NCT00098722|144202008|SUPERIORITY_OR_OTHER||LS mean difference|-0.855|STANDARD_ERROR_OF_MEAN|0.17|||TWO_SIDED|95.0|-1.189|-0.521||||||Week 48: The difference between the treatment LS means adjusted for the randomization strata was presented in addition to 2-sided 95% CI. Negative value favors maraviroc over placebo.||-0.521|-1.189|
72339222|NCT00098722|144202008|SUPERIORITY_OR_OTHER||LS mean difference|-1.033|STANDARD_ERROR_OF_MEAN|0.1685|||TWO_SIDED|95.0|-1.364|-0.701||||||Week 48: The difference between the treatment LS means adjusted for the randomization strata was presented in addition to 2-sided 95% CI. Negative value favors maraviroc over placebo.||-0.701|-1.364|
72339223|NCT02351349|144202018|OTHER|paired t test pre compared to post readings||||||0.0143|||||||t-test, 2 sided|||||||0.0143
72339224|NCT02351349|144202019|OTHER|as above||||||0.1416|||||||t-test, 2 sided|||pre and post comparison of time up and go in intervention group||||0.1416
72339225|NCT02351349|144202020|OTHER|||||||0.9013|||||||t-test, 2 sided|||pre and post value comparison with paired t test was carried out||||0.9013
72339226|NCT01610596|144202022|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Fisher Exact|||||||<0.001
72339227|NCT01519674|144202026|SUPERIORITY_OR_OTHER||Estimated treatment difference|0.24||||0.011||95.0|0.06|0.43||No corrections for multiplicity were performed.|Regression, Linear|||"The null-hypothesis (H0) was tested against the alternative hypothesis (HA) in each of the comparisons as given by:~H0: D = 0% against HA: D ≠ 0% D being the mean treatment difference for change from baseline in HbA1c after 24 weeks of treatment between the two treatment group comparisons (BID+Met and BID+Sita+Met)."||0.43|0.06|0.011
72339228|NCT01519674|144202026|SUPERIORITY_OR_OTHER||Estimated treatment difference|-0.11||||0.231||95.0|-0.3|0.07|||Regression, Linear|||The null-hypothesis (H0) was tested against the alternative hypothesis (HA) in each of the comparisons as given by: H0: D = 0% against HA: D ≠ 0% D being the mean treatment difference for change from baseline in HbA1c after 24 weeks of treatment between the two treatment group comparisons (BID+Sita+Met and OD+Sita+Met).||0.07|-0.30|0.231
72339229|NCT01519674|144202026|SUPERIORITY_OR_OTHER||Estimated treatment difference|-0.36|||<|0.001||95.0|-0.54|-0.17|||Regression, Linear|||The null-hypothesis (H0) was tested against the alternative hypothesis (HA) in each of the comparisons as given by: H0: D = 0% against HA: D ≠ 0% D being the mean treatment difference for change from baseline in HbA1c after 24 weeks of treatment between the two treatment group comparisons (BID+Sita+Met and OD+Sita+Met).||-0.17|-0.54|<0.001
72339230|NCT01519674|144202027|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.6||||0.022||95.0|0.39|0.93|||Regression, Logistic|||||0.93|0.39|0.022
72339231|NCT01519674|144202027|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.12||||0.618||95.0|0.73|1.71|||Regression, Logistic|||||1.71|0.73|0.618
72339232|NCT01519674|144202027|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.85||||0.005||95.0|1.2|2.85|||Regression, Logistic|||||2.85|1.20|0.005
72339233|NCT01519674|144202028|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.59||||0.02||95.0|0.38|0.92|||Regression, Logistic|||||0.92|0.38|0.020
72339234|NCT01519674|144202028|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.29||||0.286||95.0|0.81|2.07|||Regression, Logistic|||||2.07|0.81|0.286
72339235|NCT01519674|144202028|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.2|||<|0.001||95.0|1.39|3.47|||Regression, Logistic|||||3.47|1.39|<0.001
72339236|NCT01519674|144202029|SUPERIORITY_OR_OTHER||Estimated treatment difference|0.13||||0.52||95.0|-0.26|0.52|||Regression, Linear|||||0.52|-0.26|0.520
72339237|NCT01519674|144202029|SUPERIORITY_OR_OTHER||Estimated treatment difference|0.05||||0.788||95.0|-0.34|0.45|||Regression, Linear|||||0.45|-0.34|0.788
72339238|NCT01519674|144202029|SUPERIORITY_OR_OTHER||Estimated treatment difference|-0.07||||0.708||95.0|-0.46|0.31|||Regression, Linear|||||0.31|-0.46|0.708
72339239|NCT01519674|144202030|SUPERIORITY_OR_OTHER||Estimated treatment difference|0.28||||0.291||95.0|-0.24|0.81|||Regression, Linear|||||0.81|-0.24|0.291
72339240|NCT01519674|144202030|SUPERIORITY_OR_OTHER||Estimated treatment difference|-0.88||||0.001||95.0|-1.41|-0.35|||Regression, Linear|||||-0.35|-1.41|0.001
72339241|NCT01519674|144202030|SUPERIORITY_OR_OTHER||Estimated treatment difference|-1.16|||<|0.001||95.0|-1.69|-0.64|||Regression, Linear|||||-0.64|-1.69|<0.001
72339242|NCT01519674|144202031|SUPERIORITY_OR_OTHER||Estimated treatment difference|0.85||||0.005||95.0|0.26|1.45|||Regression, Linear|||||1.45|0.26|0.005
72339243|NCT01519674|144202031|SUPERIORITY_OR_OTHER||Estimated treatment difference|0.52||||0.085||95.0|-0.07|1.12|||Regression, Linear|||||1.12|-0.07|0.085
72339244|NCT01519674|144202031|SUPERIORITY_OR_OTHER||Estimated treatment difference|-0.33||||0.275||95.0|-0.92|0.26|||Regression, Linear|||||0.26|-0.92|0.275
72339245|NCT01519674|144202032|SUPERIORITY_OR_OTHER||Estimated treatment difference|-0.12||||0.674||95.0|-0.7|0.45|||Regression, Linear|||||0.45|-0.70|0.674
72339246|NCT01519674|144202032|SUPERIORITY_OR_OTHER||Estimated treatment difference|0.72||||0.015||95.0|0.14|1.3|||Regression, Linear|||||1.30|0.14|0.015
72339247|NCT01519674|144202032|SUPERIORITY_OR_OTHER||Estimated treatment difference|0.84||||0.004||95.0|0.27|1.41|||Regression, Linear|||||1.41|0.27|0.004
72339248|NCT01519674|144202033|SUPERIORITY_OR_OTHER||Estimated treatment difference|0.31||||0.08||95.0|-0.04|0.65|||Regression, Linear|||||0.65|-0.04|0.080
72339249|NCT01519674|144202033|SUPERIORITY_OR_OTHER||Estimated treatment difference|0.09||||0.613||95.0|-0.26|0.43|||Regression, Linear|||||0.43|-0.26|0.613
72339250|NCT01519674|144202033|SUPERIORITY_OR_OTHER||Estimated treatment difference|-0.22||||0.213||95.0|-0.56|0.13|||Regression, Linear|||||0.13|-0.56|0.213
72339251|NCT01519674|144202036|SUPERIORITY_OR_OTHER||Estimated treatment difference|0.29||||0.8||95.0|-1.97|2.56|||Regression, Linear|||||2.56|-1.97|0.800
72339252|NCT01519674|144202036|SUPERIORITY_OR_OTHER||Estimated treatment difference|0.02||||0.989||95.0|-2.26|2.29|||Regression, Linear|||||2.29|-2.26|0.989
72339253|NCT01519674|144202036|SUPERIORITY_OR_OTHER||Estimated treatment difference|-0.28||||0.809||95.0|-2.52|1.97|||Regression, Linear|||||1.97|-2.52|0.809
72339254|NCT01804582|144202073|SUPERIORITY_OR_OTHER_LEGACY|||||||0.15|||||||Mixed Models Analysis|||An intent to treat analysis was conducted using a linear mixed model to determine if there was any significant difference in change from baseline to 3 months based on time and condition. Data for all participants was included at baseline and 3 months.||||.15
72339255|NCT01804582|144202074|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.07||||0.53|TWO_SIDED||||||Mixed Models Analysis||Cohen's d was calculated to measure the estimation parameter.|||||.53
72339256|NCT01804582|144202075|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.03||||0.8|TWO_SIDED||||||Mixed Models Analysis|||||||.80
72339257|NCT01804582|144202076|SUPERIORITY_OR_OTHER_LEGACY|||||||0.33|||||||Mixed Models Analysis|||||||.33
72339258|NCT01804582|144202077|SUPERIORITY_OR_OTHER_LEGACY|||||||0.21|||||||Wald Chi-Squared|||||||.21
72339259|NCT01804582|144202078|SUPERIORITY_OR_OTHER_LEGACY||Phi|0.19||||0.005|TWO_SIDED||||||Chi-squared|Chi Squared (1, N = 229) = 7.99.||The total n=229 included those on medication at 90 days (119 never filled the prescription or changed to a different med)||||.005
72339260|NCT01149486|144202091|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|93.45|||||TWO_SIDED|90.0|80.2|108.88|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||108.88|80.20|
72339261|NCT01149486|144202092|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|99.45|||||TWO_SIDED|90.0|93.15|106.18|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||106.18|93.15|
72339262|NCT01149486|144202093|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|99.4|||||TWO_SIDED|90.0|93.1|106.12|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||106.12|93.10|
72339263|NCT01149486|144202094|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|111.62|||||TWO_SIDED|90.0|101.47|122.79|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||122.79|101.47|
72339264|NCT01149486|144202095|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|105.8|||||TWO_SIDED|90.0|99.58|112.41|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||112.41|99.58|
72428363|NCT01811563|144367729|EQUIVALENCE|Main effect for implant, baseline to 52 weeks||||||0.416|||||||ANOVA|||||||.416
72428364|NCT01811563|144367729|EQUIVALENCE|Main effect for time, Baseline to 52 weeks|||||<|0.001|||||||ANOVA|||||||<0.001
72428365|NCT01811563|144367729|EQUIVALENCE|Implant by time interaction, baseline to 52 weeks||||||0.917|||||||ANOVA|||||||0.917
72339265|NCT01149486|144202096|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|105.55|||||TWO_SIDED|90.0|99.64|111.82|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||111.82|99.64|
72339266|NCT01149486|144202097|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|106.78|||||TWO_SIDED|90.0|98.96|115.23|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||115.23|98.96|
72339267|NCT01149486|144202098|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|102.37|||||TWO_SIDED|90.0|98.75|106.14|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||106.14|98.75|
72339268|NCT01149486|144202099|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|102.3|||||TWO_SIDED|90.0|98.72|106.01|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||106.01|98.72|
72339269|NCT02699450|144202156|SUPERIORITY||Difference in Least Squares Means|1.4||||0.37|TWO_SIDED|80.0|-0.6|3.4||There was no formal correction for multiple comparisons. Test for Arm B vs. Arm A was carried out at one-sided 10% alpha.|Mixed Effects Model of Repeated Measures|Categorical covariates: treatment group, categorical visit, and visit by treatment group, stratification factors; continuous covariate: baseline BCVA.|The mean difference between arms was calculated as Arm B minus Arm A.|Null hypothesis (H0): There is no difference between either of the faricimab treatment arms (Arms B and C) and the active comparator ranibizumab treatment arm (Arm A). The alternative hypothesis (Ha): Either of the faricimab treatment arms (Arm B or C) is different from the ranibizumab treatment arm (Arm A).||3.4|-0.6|0.37
72339270|NCT02699450|144202156|SUPERIORITY||Difference in Least Squares Means|3.6||||0.03|TWO_SIDED|80.0|1.5|5.6||There was no formal correction for multiple comparisons. Test for Arm C vs. Arm A was carried out at one-sided 10% alpha.|Mixed Effects Model of Repeated Measures|Categorical covariates: treatment group, categorical visit, and visit by treatment group, stratification factors; continuous covariate: baseline BCVA.|The mean difference between arms was calculated as Arm C minus Arm A.|Null hypothesis (H0): There is no difference between either of the faricimab treatment arms (Arms B and C) and the active comparator ranibizumab treatment arm (Arm A). The alternative hypothesis (Ha): Either of the faricimab treatment arms (Arm B or C) is different from the ranibizumab treatment arm (Arm A).||5.6|1.5|0.03
72339271|NCT02699450|144202157|SUPERIORITY||Difference in Least Squares Means|1.3||||0.63|TWO_SIDED|80.0|-2.3|5.0||There was no formal correction for multiple comparisons. Test for Arm C vs. Arm A was carried out at one-sided 10% alpha.|Mixed Effects Model of Repeated Measures|Categorical covariates: treatment group, categorical visit, and visit by treatment group, stratification factors; continuous covariate: baseline BCVA.|The mean difference between arms was calculated as Arm C minus Arm A.|Null hypothesis (H0): There is no difference between either of the faricimab treatment arm (Arm C) and the active comparator ranibizumab treatment arm (Arm A). The alternative hypothesis (Ha): The faricimab treatment arms (Arm C) is different from the ranibizumab treatment arm (Arm A).||5.0|-2.3|0.63
72339272|NCT02699450|144202158|SUPERIORITY||Difference in Least Squares Means|2.3||||0.15|TWO_SIDED|80.0|0.2|4.3||There was no formal correction for multiple comparisons. Test for Arm B vs. Arm A was carried out at one-sided 10% alpha.|Mixed Effects Model of Repeated Measures|Categorical covariates: treatment group, categorical visit, and visit by treatment group, stratification factors; continuous covariate: baseline BCVA.|The mean difference between arms was calculated as Arm B minus Arm A.|Null hypothesis (H0): There is no difference between either of the faricimab treatment arms (Arms B and C) and the active comparator ranibizumab treatment arm (Arm A). The alternative hypothesis (Ha): Either of the faricimab treatment arms (Arm B or C) is different from the ranibizumab treatment arm (Arm A).||4.3|0.2|0.15
72339273|NCT02699450|144202158|SUPERIORITY||Difference in Least Squares Means|2.9||||0.04|TWO_SIDED|80.0|1.1|4.7||There was no formal correction for multiple comparisons. Test for Arm C vs. Arm A was carried out at one-sided 10% alpha.|Mixed Effects Model of Repeated Measures|Categorical covariates: treatment group, categorical visit, and visit by treatment group, stratification factors; continuous covariate: baseline BCVA.|The mean difference between arms was calculated as Arm C minus Arm A.|Null hypothesis (H0): There is no difference between either of the faricimab treatment arms (Arms B and C) and the active comparator ranibizumab treatment arm (Arm A). The alternative hypothesis (Ha): Either of the faricimab treatment arms (Arm B or C) is different from the ranibizumab treatment arm (Arm A).||4.7|1.1|0.04
72339274|NCT02699450|144202159|SUPERIORITY||Difference in Least Squares Means|0.8||||0.94|TWO_SIDED|80.0|-11.3|12.8||There was no formal correction for multiple comparisons. Test for Arm B vs. Arm A was carried out at one-sided 10% alpha.|Generalized Estimating Equations Model|Categorical covariates: treatment group, visit, and visit by treatment group interaction term.|The mean difference between arms was calculated as Arm B minus Arm A.|Null hypothesis (H0): There is no difference between either of the faricimab treatment arms (Arms B and C) and the active comparator ranibizumab treatment arm (Arm A). The alternative hypothesis (Ha): Either of the faricimab treatment arms (Arm B or C) is different from the ranibizumab treatment arm (Arm A).||12.8|-11.3|0.94
72428366|NCT01811563|144367731|EQUIVALENCE|Main effect by implant, Baseline to 52 weeks||||||0.83|||||||ANOVA|||||||0.830
72339275|NCT02699450|144202159|SUPERIORITY||Difference in Least Squares Means|7.3||||0.46|TWO_SIDED|80.0|-5.4|19.9||There was no formal correction for multiple comparisons. Test for Arm C vs. Arm A was carried out at one-sided 10% alpha.|Generalized Estimating Equations Model|Categorical covariates: treatment group, visit, and visit by treatment group interaction term.|The mean difference between arms was calculated as Arm C minus Arm A.|Null hypothesis (H0): There is no difference between either of the faricimab treatment arms (Arms B and C) and the active comparator ranibizumab treatment arm (Arm A). The alternative hypothesis (Ha): Either of the faricimab treatment arms (Arm B or C) is different from the ranibizumab treatment arm (Arm A).||19.9|-5.4|0.46
72339276|NCT02699450|144202160|SUPERIORITY||Difference in Percentage of Participants|6.4||||0.56|TWO_SIDED|80.0|-7.7|20.5||There was no formal correction for multiple comparisons. Test for Arm C vs. Arm A was carried out at one-sided 10% alpha.|Generalized Estimating Equations Model|Categorical covariates: treatment group, visit, and visit by treatment group interaction term.|The mean difference between arms was calculated as Arm C minus Arm A.|Null hypothesis (H0): There is no difference between either of the faricimab treatment arm (Arm C) and the active comparator ranibizumab treatment arm (Arm A). The alternative hypothesis (Ha): The faricimab treatment arms (Arm C) is different from the ranibizumab treatment arm (Arm A).||20.5|-7.7|0.56
72339277|NCT02699450|144202161|SUPERIORITY||Difference in Least Squares Means|6.6||||0.43|TWO_SIDED|80.0|-4.0|17.2||There was no formal correction for multiple comparisons. Test for Arm B vs. Arm A was carried out at one-sided 10% alpha.|Generalized Estimating Equations Model|Categorical covariates: treatment group, visit, and visit by treatment group interaction term.|The mean difference between arms was calculated as Arm B minus Arm A.|Null hypothesis (H0): There is no difference between either of the faricimab treatment arms (Arms B and C) and the active comparator ranibizumab treatment arm (Arm A). The alternative hypothesis (Ha): Either of the faricimab treatment arms (Arm B or C) is different from the ranibizumab treatment arm (Arm A).||17.2|-4.0|0.43
72339278|NCT02699450|144202161|SUPERIORITY||Difference in Least Squares Means|7.2||||0.34|TWO_SIDED|80.0|-2.6|17.0||There was no formal correction for multiple comparisons. Test for Arm C vs. Arm A was carried out at one-sided 10% alpha.|Generalized Estimating Equations Model|Categorical covariates: treatment group, visit, and visit by treatment group interaction term.|The mean difference between arms was calculated as Arm C minus Arm A.|Null hypothesis (H0): There is no difference between either of the faricimab treatment arms (Arms B and C) and the active comparator ranibizumab treatment arm (Arm A). The alternative hypothesis (Ha): Either of the faricimab treatment arms (Arm B or C) is different from the ranibizumab treatment arm (Arm A).||17.0|-2.6|0.34
72339279|NCT02699450|144202162|SUPERIORITY||Difference in Least Squares Means|9.5||||0.27|TWO_SIDED|80.0|-1.6|20.6||There was no formal correction for multiple comparisons. Test for Arm B vs. Arm A was carried out at one-sided 10% alpha.|Generalized Estimating Equations Model|Categorical covariates: treatment group, visit, and visit by treatment group interaction term.|The mean difference between arms was calculated as Arm B minus Arm A.|Null hypothesis (H0): There is no difference between either of the faricimab treatment arms (Arms B and C) and the active comparator ranibizumab treatment arm (Arm A). The alternative hypothesis (Ha): Either of the faricimab treatment arms (Arm B or C) is different from the ranibizumab treatment arm (Arm A).||20.6|-1.6|0.27
72339280|NCT02699450|144202162|SUPERIORITY||Difference in Least Squares Means|6.8||||0.45|TWO_SIDED|80.0|-4.9|18.5||There was no formal correction for multiple comparisons. Test for Arm C vs. Arm A was carried out at one-sided 10% alpha.|Generalized Estimating Equations Model|Categorical covariates: treatment group, visit, and visit by treatment group interaction term.|The mean difference between arms was calculated as Arm C minus Arm A.|Null hypothesis (H0): There is no difference between either of the faricimab treatment arms (Arms B and C) and the active comparator ranibizumab treatment arm (Arm A). The alternative hypothesis (Ha): Either of the faricimab treatment arms (Arm B or C) is different from the ranibizumab treatment arm (Arm A).||18.5|-4.9|0.45
72339281|NCT02699450|144202163|SUPERIORITY||Difference in Least Squares Means|-0.6||||0.96|TWO_SIDED|80.0|-16.8|15.5||There was no formal correction for multiple comparisons. Test for Arm C vs. Arm A was carried out at one-sided 10% alpha.|Generalized Estimating Equations Model|Categorical covariates: treatment group, visit, and visit by treatment group interaction term.|The mean difference between arms was calculated as Arm C minus Arm A.|Null hypothesis (H0): There is no difference between either of the faricimab treatment arm (Arm C) and the active comparator ranibizumab treatment arm (Arm A). The alternative hypothesis (Ha): The faricimab treatment arms (Arm C) is different from the ranibizumab treatment arm (Arm A).||15.5|-16.8|0.96
72339282|NCT02699450|144202164|SUPERIORITY||Difference in Least Squares Means|9.9||||0.19|TWO_SIDED|80.0|0.1|19.7||There was no formal correction for multiple comparisons. Test for Arm B vs. Arm A was carried out at one-sided 10% alpha.|Generalized Estimating Equations Model|Categorical covariates: treatment group, visit, and visit by treatment group interaction term.|The mean difference between arms was calculated as Arm B minus Arm A.|Null hypothesis (H0): There is no difference between either of the faricimab treatment arms (Arms B and C) and the active comparator ranibizumab treatment arm (Arm A). The alternative hypothesis (Ha): Either of the faricimab treatment arms (Arm B or C) is different from the ranibizumab treatment arm (Arm A).||19.7|0.1|0.19
72339283|NCT02699450|144202164|SUPERIORITY||Difference in Least Squares Means|4.2||||0.57|TWO_SIDED|80.0|-5.3|13.6||There was no formal correction for multiple comparisons. Test for Arm C vs. Arm A was carried out at one-sided 10% alpha.|Generalized Estimating Equations Model|Categorical covariates: treatment group, visit, and visit by treatment group interaction term.|The mean difference between arms was calculated as Arm C minus Arm A.|Null hypothesis (H0): There is no difference between either of the faricimab treatment arms (Arms B and C) and the active comparator ranibizumab treatment arm (Arm A). The alternative hypothesis (Ha): Either of the faricimab treatment arms (Arm B or C) is different from the ranibizumab treatment arm (Arm A).||13.6|-5.3|0.57
72339284|NCT02699450|144202165|SUPERIORITY||Difference in Least Squares Means|-2.8||||0.64|TWO_SIDED|80.0|-10.5|4.9||There was no formal correction for multiple comparisons. Test for Arm B vs. Arm A was carried out at one-sided 10% alpha.|Generalized Estimating Equations Model|Categorical covariates: treatment group, visit, and visit by treatment group interaction term.|The mean difference between arms was calculated as Arm B minus Arm A.|Null hypothesis (H0): There is no difference between either of the faricimab treatment arms (Arms B and C) and the active comparator ranibizumab treatment arm (Arm A). The alternative hypothesis (Ha): Either of the faricimab treatment arms (Arm B or C) is different from the ranibizumab treatment arm (Arm A).||4.9|-10.5|0.64
72339285|NCT02699450|144202165|SUPERIORITY||Difference in Least Squares Means|-1.8||||0.78|TWO_SIDED|80.0|-9.8|6.2||There was no formal correction for multiple comparisons. Test for Arm C vs. Arm A was carried out at one-sided 10% alpha.|Generalized Estimating Equations Model|Categorical covariates: treatment group, visit, and visit by treatment group interaction term.|The mean difference between arms was calculated as Arm C minus Arm A.|Null hypothesis (H0): There is no difference between either of the faricimab treatment arms (Arms B and C) and the active comparator ranibizumab treatment arm (Arm A). The alternative hypothesis (Ha): Either of the faricimab treatment arms (Arm B or C) is different from the ranibizumab treatment arm (Arm A).||6.2|-9.8|0.78
72339286|NCT02699450|144202166|SUPERIORITY||Difference in Least Squares Means|-2.3||||0.78|TWO_SIDED|80.0|-12.7|8.2||There was no formal correction for multiple comparisons. Test for Arm C vs. Arm A was carried out at one-sided 10% alpha.|Generalized Estimating Equations Model|Categorical covariates: treatment group, visit, and visit by treatment group interaction term.|The mean difference between arms was calculated as Arm C minus Arm A.|Null hypothesis (H0): There is no difference between either of the faricimab treatment arm (Arm C) and the active comparator ranibizumab treatment arm (Arm A). The alternative hypothesis (Ha): The faricimab treatment arms (Arm C) is different from the ranibizumab treatment arm (Arm A).||8.2|-12.7|0.78
72339287|NCT02699450|144202167|SUPERIORITY||Difference in Least Squares Means|-0.5||||0.93|TWO_SIDED|80.0|-7.7|6.7||There was no formal correction for multiple comparisons. Test for Arm B vs. Arm A was carried out at one-sided 10% alpha.|Generalized Estimating Equations Model|Categorical covariates: treatment group, visit, and visit by treatment group interaction term.|The mean difference between arms was calculated as Arm B minus Arm A.|Null hypothesis (H0): There is no difference between either of the faricimab treatment arms (Arms B and C) and the active comparator ranibizumab treatment arm (Arm A). The alternative hypothesis (Ha): Either of the faricimab treatment arms (Arm B or C) is different from the ranibizumab treatment arm (Arm A).||6.7|-7.7|0.93
72339288|NCT02699450|144202167|SUPERIORITY||Difference in Least Squares Means|-2.0||||0.69|TWO_SIDED|80.0|-8.3|4.4||There was no formal correction for multiple comparisons. Test for Arm C vs. Arm A was carried out at one-sided 10% alpha.|Generalized Estimating Equations Model|Categorical covariates: treatment group, visit, and visit by treatment group interaction term.|The mean difference between arms was calculated as Arm C minus Arm A.|Null hypothesis (H0): There is no difference between either of the faricimab treatment arms (Arms B and C) and the active comparator ranibizumab treatment arm (Arm A). The alternative hypothesis (Ha): Either of the faricimab treatment arms (Arm B or C) is different from the ranibizumab treatment arm (Arm A).||4.4|-8.3|0.69
72339289|NCT02699450|144202168|SUPERIORITY||Difference in Least Squares Means|-6.5||||0.69|TWO_SIDED|80.0|-27.8|14.7||There was no formal correction for multiple comparisons. Test for Arm B vs. Arm A was carried out at one-sided 10% alpha.|Mixed Effects Model of Repeated Measures|Categorical covariates: treatment group, categorical visit, and visit by treatment group, stratification factors; continuous covariate: baseline FCPT.|The mean difference between arms was calculated as Arm B minus Arm A.|Null hypothesis (H0): There is no difference between either of the faricimab treatment arms (Arms B and C) and the active comparator ranibizumab treatment arm (Arm A). The alternative hypothesis (Ha): Either of the faricimab treatment arms (Arm B or C) is different from the ranibizumab treatment arm (Arm A).||14.7|-27.8|0.69
72339290|NCT02699450|144202168|SUPERIORITY||Difference in Least Squares Means|-22.8||||0.18|TWO_SIDED|80.0|-44.5|-1.2||There was no formal correction for multiple comparisons. Test for Arm C vs. Arm A was carried out at one-sided 10% alpha.|Mixed Effects Model of Repeated Measures|Categorical covariates: treatment group, categorical visit, and visit by treatment group, stratification factors; continuous covariate: baseline FCPT.|The mean difference between arms was calculated as Arm C minus Arm A.|Null hypothesis (H0): There is no difference between either of the faricimab treatment arms (Arms B and C) and the active comparator ranibizumab treatment arm (Arm A). The alternative hypothesis (Ha): Either of the faricimab treatment arms (Arm B or C) is different from the ranibizumab treatment arm (Arm A).||-1.2|-44.5|0.18
72339291|NCT02699450|144202169|SUPERIORITY||Difference in Least Squares Means|-49.2||||0.07|TWO_SIDED|80.0|-84.2|-14.2||There was no formal correction for multiple comparisons. Test for Arm C vs. Arm A was carried out at one-sided 10% alpha.|Mixed Effects Model of Repeated Measures|Categorical covariates: treatment group, categorical visit, and visit by treatment group, stratification factors; continuous covariate: baseline FCPT.|The mean difference between arms was calculated as Arm C minus Arm A.|Null hypothesis (H0): There is no difference between either of the faricimab treatment arm (Arm C) and the active comparator ranibizumab treatment arm (Arm A). The alternative hypothesis (Ha): The faricimab treatment arms (Arm C) is different from the ranibizumab treatment arm (Arm A).||-14.2|-84.2|0.07
72339292|NCT02699450|144202170|SUPERIORITY||Difference in Least Squares Means|-17.3||||0.28|TWO_SIDED|80.0|-38.0|3.4||There was no formal correction for multiple comparisons. Test for Arm B vs. Arm A was carried out at one-sided 10% alpha.|Mixed Effects Model of Repeated Measures|Categorical covariates: treatment group, categorical visit, and visit by treatment group, stratification factors; continuous covariate: baseline FCPT.|The mean difference between arms was calculated as Arm B minus Arm A.|Null hypothesis (H0): There is no difference between either of the faricimab treatment arms (Arms B and C) and the active comparator ranibizumab treatment arm (Arm A). The alternative hypothesis (Ha): Either of the faricimab treatment arms (Arm B or C) is different from the ranibizumab treatment arm (Arm A).||3.4|-38.0|0.28
72339293|NCT02699450|144202170|SUPERIORITY||Difference in Least Squares Means|-29.2||||0.05|TWO_SIDED|80.0|-47.8|-10.6||There was no formal correction for multiple comparisons. Test for Arm C vs. Arm A was carried out at one-sided 10% alpha.|Mixed Effects Model of Repeated Measures|Categorical covariates: treatment group, categorical visit, and visit by treatment group, stratification factors; continuous covariate: baseline FCPT.|The mean difference between arms was calculated as Arm C minus Arm A.|Null hypothesis (H0): There is no difference between either of the faricimab treatment arms (Arms B and C) and the active comparator ranibizumab treatment arm (Arm A). The alternative hypothesis (Ha): Either of the faricimab treatment arms (Arm B or C) is different from the ranibizumab treatment arm (Arm A).||-10.6|-47.8|0.05
72428367|NCT01811563|144367731|EQUIVALENCE|Main effect by time, baseline to 52 weeks|||||<|0.001|||||||ANOVA|||||||<0.001
72428368|NCT01811563|144367731|EQUIVALENCE|Interaction between implant and time, baseline to 52 weeks||||||0.728|||||||ANOVA|||||||0.728
72428369|NCT01811563|144367732|EQUIVALENCE|Between implants at 6 weeks||||||0.319|||||||t-test, 2 sided|||||||0.319
72428370|NCT01327547|144367736|SUPERIORITY_OR_OTHER||Difference in proportion|-0.002||||0.4598|TWO_SIDED|95.0|-0.0417|0.0376|||Cochran-Mantel-Haenszel||Difference in proportion: CMH approach weighted by hepatitis B virus (HBV) status and usage of protease inhibitor (PI) regimen strata was used to calculate the statistics.|A stratified analysis was conducted by summarizing the difference in proportions adjusted for the randomization strata formed by crossing levels of stratification variables. The Cochran-Mantel-Haenszel (CMH) approach was used. No formal hypothesis test was performed.||0.0376|-0.0417|0.4598
72428371|NCT01327547|144367737|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.0167|||||TWO_SIDED|95.0|-0.0653|0.0319|||||CMH approach weighted by HBV status and usage of PI regiment strata, is used to calculate the statistics. The point estimate and 95% CI are difference in proportions between MVC and placebo for the participants meeting secondary endpoint.|||0.0319|-0.0653|
72428372|NCT01327547|144367737|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.0177|||||TWO_SIDED|95.0|-0.0805|0.0452|||||CMH approach weighted by HBV status and usage of PI regiment strata, is used to calculate the statistics. The point estimate and 95% CI are difference in proportions between maraviroc and placebo for the participants meeting secondary endpoint.|||0.0452|-0.0805|
72428373|NCT01327547|144367742|SUPERIORITY_OR_OTHER||Difference in proportion|-0.015|||||TWO_SIDED|95.0|-0.1484|0.1185|||||Difference in proportion: CMH approach weighted by HBV status and usage of PI regimen strata was used to calculate the statistics.|A stratified analysis was conducted by summarizing the difference in proportions adjusted for the randomization strata formed by crossing levels of stratification variables. The CMH approach was used. No formal hypothesis test was performed. Week 48 data presented here.||0.1185|-0.1484|
72428374|NCT01327547|144367742|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.0255|||||TWO_SIDED|95.0|-0.1784|0.1274|||||Difference in proportion: CMH approach weighted by HBV status and usage of PI regimen strata was used to calculate the statistics.|A stratified analysis was conducted by summarizing the difference in proportions adjusted for the randomization strata formed by crossing levels of stratification variables. The CMH approach was used. No formal hypothesis test was performed. Week 96 data presented here.||0.1274|-0.1784|
72428375|NCT01327547|144367742|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.083|||||TWO_SIDED|95.0|-0.2421|0.0761|||||Difference in proportion: CMH approach weighted by HBV status and usage of PI regimen strata was used to calculate the statistics.|A stratified analysis was conducted by summarizing the difference in proportions adjusted for the randomization strata formed by crossing levels of stratification variables. The CMH approach was used. No formal hypothesis test was performed. Week 144 data presented here.||0.0761|-0.2421|
72428376|NCT01327547|144367743|SUPERIORITY_OR_OTHER||Difference in Least Square (LS) Mean|-41.12||||0.1174|TWO_SIDED|95.0|-92.72|10.49|||ANCOVA||Difference in Least Square (LS) Mean|The above analysis is for CD4+ cells at week 48. Results are from an analysis of covariance (ANCOVA) model with change from baseline as the response variable and the following fixed effect model terms: treatment (Maraviroc or placebo), baseline value of the response variable, hepatitis B virus status (HBV), Protease inhibitor (PI)-based regimen.||10.49|-92.72|0.1174
72428377|NCT01327547|144367743|SUPERIORITY_OR_OTHER||Difference in LS Mean|-21.96||||0.593|TWO_SIDED|95.0|-103.05|59.12|||ANCOVA||Difference in LS Mean|The above analysis is for CD8+ cells at Week 48. Results are from an ANCOVA model with change from baseline as the response variable and the following fixed effect model terms: treatment (Maraviroc or placebo), baseline value of the response variable, hepatitis B virus status (HBV), Protease inhibitor (PI)-based regimen.||59.12|-103.05|0.5930
72428378|NCT01327547|144367743|SUPERIORITY_OR_OTHER||Difference in LS Mean|-48.26||||0.0669|TWO_SIDED|95.0|-99.93|3.41|||ANCOVA|||The above analysis is for CD4+ cells at Week 96. Results are from an ANCOVA model with change from baseline as the response variable and the following fixed effect model terms: treatment (Maraviroc or placebo), baseline value of the response variable, hepatitis B virus status (HBV), Protease inhibitor (PI)-based regimen.||3.41|-99.93|0.0669
72339294|NCT02699450|144202171|SUPERIORITY||Difference in Least Squares Means|-12.4||||0.36|TWO_SIDED|80.0|-29.7|5.0||There was no formal correction for multiple comparisons. Test for Arm B vs. Arm A was carried out at one-sided 10% alpha.|Mixed Effects Model of Repeated Measures|Categorical covariates: treatment group, categorical visit, and visit by treatment group, stratification factors; continuous covariate: baseline CST.|The mean difference between arms was calculated as Arm B minus Arm A.|Null hypothesis (H0): There is no difference between either of the faricimab treatment arms (Arms B and C) and the active comparator ranibizumab treatment arm (Arm A). The alternative hypothesis (Ha): Either of the faricimab treatment arms (Arm B or C) is different from the ranibizumab treatment arm (Arm A).||5.0|-29.7|0.36
72339295|NCT02699450|144202171|SUPERIORITY||Difference in Least Squares Means|-21.1||||0.13|TWO_SIDED|80.0|-38.7|-3.5||There was no formal correction for multiple comparisons. Test for Arm C vs. Arm A was carried out at one-sided 10% alpha.|Mixed Effects Model of Repeated Measures|Categorical covariates: treatment group, categorical visit, and visit by treatment group, stratification factors; continuous covariate: baseline CST.|The mean difference between arms was calculated as Arm C minus Arm A.|Null hypothesis (H0): There is no difference between either of the faricimab treatment arms (Arms B and C) and the active comparator ranibizumab treatment arm (Arm A). The alternative hypothesis (Ha): Either of the faricimab treatment arms (Arm B or C) is different from the ranibizumab treatment arm (Arm A).||-3.5|-38.7|0.13
72428379|NCT01327547|144367743|SUPERIORITY_OR_OTHER||Difference in LS Mean|-65.28||||0.1799|TWO_SIDED|95.0|-161.07|30.5|||ANCOVA|||The above analysis is for CD8+ cells at Week 96. Results are from an ANCOVA model with change from baseline as the response variable and the following fixed effect model terms: treatment (Maraviroc or placebo), baseline value of the response variable, hepatitis B virus status (HBV), Protease inhibitor (PI)-based regimen.||30.50|-161.07|0.1799
72428380|NCT01327547|144367743|SUPERIORITY_OR_OTHER||Difference in LS Mean|-27.71||||0.3859|TWO_SIDED|95.0|-90.71|35.29|||ANCOVA|||The above analysis is for CD4+ cells at Week 144. Results are from an ANCOVA model with change from baseline as the response variable and the following fixed effect model terms: treatment (Maraviroc or placebo), baseline value of the response variable, hepatitis B virus status (HBV), Protease inhibitor (PI)-based regimen.||35.29|-90.71|0.3859
72339296|NCT02699450|144202172|SUPERIORITY||Difference in Least Squares Means|-38.6||||0.07|TWO_SIDED|80.0|-65.9|-11.3||There was no formal correction for multiple comparisons. Test for Arm C vs. Arm A was carried out at one-sided 10% alpha.|Mixed Effects Model of Repeated Measures|Categorical covariates: treatment group, categorical visit, and visit by treatment group, stratification factors; continuous covariate: baseline CST.|The mean difference between arms was calculated as Arm C minus Arm A.|Null hypothesis (H0): There is no difference between either of the faricimab treatment arm (Arm C) and the active comparator ranibizumab treatment arm (Arm A). The alternative hypothesis (Ha): The faricimab treatment arms (Arm C) is different from the ranibizumab treatment arm (Arm A).||-11.3|-65.9|0.07
72339297|NCT02699450|144202173|SUPERIORITY||Difference in Least Squares Means|-20.1||||0.12|TWO_SIDED|80.0|-36.4|-3.8||There was no formal correction for multiple comparisons. Test for Arm B vs. Arm A was carried out at one-sided 10% alpha.|Mixed Effects Model of Repeated Measures|Categorical covariates: treatment group, categorical visit, and visit by treatment group, stratification factors; continuous covariate: baseline CST.|The mean difference between arms was calculated as Arm B minus Arm A.|Null hypothesis (H0): There is no difference between either of the faricimab treatment arms (Arms B and C) and the active comparator ranibizumab treatment arm (Arm A). The alternative hypothesis (Ha): Either of the faricimab treatment arms (Arm B or C) is different from the ranibizumab treatment arm (Arm A).||-3.8|-36.4|0.12
72339298|NCT02699450|144202173|SUPERIORITY||Difference in Least Squares Means|-26.7||||0.02|TWO_SIDED|80.0|-41.3|-12.0||There was no formal correction for multiple comparisons. Test for Arm C vs. Arm A was carried out at one-sided 10% alpha.|Mixed Effects Model of Repeated Measures|Categorical covariates: treatment group, categorical visit, and visit by treatment group, stratification factors; continuous covariate: baseline CST.|The mean difference between arms was calculated as Arm C minus Arm A.|Null hypothesis (H0): There is no difference between either of the faricimab treatment arms (Arms B and C) and the active comparator ranibizumab treatment arm (Arm A). The alternative hypothesis (Ha): Either of the faricimab treatment arms (Arm B or C) is different from the ranibizumab treatment arm (Arm A).||-12.0|-41.3|0.02
72339299|NCT02699450|144202174|SUPERIORITY||Difference in Percentage of Participants|-4.08||||0.4948|TWO_SIDED|80.0|-7.7|-0.46||There was no formal correction for multiple comparisons. Test for Arm B vs. Arm A was carried out at one-sided 10% alpha.|Fisher Exact||The difference between arms was calculated as Arm B minus Arm A.|Null hypothesis (H0): There is no difference between either of the faricimab treatment arms (Arms B and C) and the active comparator ranibizumab treatment arm (Arm A). The alternative hypothesis (Ha): Either of the faricimab treatment arms (Arm B or C) is different from the ranibizumab treatment arm (Arm A).||-0.46|-7.70|0.4948
72339300|NCT02699450|144202174|SUPERIORITY||Difference in Percentage of Participants|-4.08||||0.496|TWO_SIDED|80.0|-7.7|-0.46||There was no formal correction for multiple comparisons. Test for Arm C vs. Arm A was carried out at one-sided 10% alpha.|Fisher Exact||The difference between arms was calculated as Arm C minus Arm A.|Null hypothesis (H0): There is no difference between either of the faricimab treatment arms (Arms B and C) and the active comparator ranibizumab treatment arm (Arm A). The alternative hypothesis (Ha): Either of the faricimab treatment arms (Arm B or C) is different from the ranibizumab treatment arm (Arm A).||-0.46|-7.70|0.4960
72339301|NCT02699450|144202175|SUPERIORITY||Difference in Percentage of Participants|-2.8||||1|TWO_SIDED|80.0|-11.08|5.49||There was no formal correction for multiple comparisons. Test for Arm C vs. Arm A was carried out at one-sided 10% alpha.|Fisher Exact||The difference between arms was calculated as Arm C minus Arm A.|Null hypothesis (H0): There is no difference between either of the faricimab treatment arm (Arm C) and the active comparator ranibizumab treatment arm (Arm A). The alternative hypothesis (Ha): The faricimab treatment arms (Arm C) is different from the ranibizumab treatment arm (Arm A).||5.49|-11.08|1.0000
72339302|NCT02699450|144202176|SUPERIORITY||Difference in Percentage of Participants|-6.12||||0.5759|TWO_SIDED|80.0|-15.41|3.17||There was no formal correction for multiple comparisons. Test for Arm B vs. Arm A was carried out at one-sided 10% alpha.|Fisher Exact||The difference between arms was calculated as Arm B minus Arm A.|Null hypothesis (H0): There is no difference between either of the faricimab treatment arms (Arms B and C) and the active comparator ranibizumab treatment arm (Arm A). The alternative hypothesis (Ha): Either of the faricimab treatment arms (Arm B or C) is different from the ranibizumab treatment arm (Arm A).||3.17|-15.41|0.5759
72339303|NCT02699450|144202176|SUPERIORITY||Difference in Percentage of Participants|3.15||||0.7437|TWO_SIDED|80.0|-5.02|11.33||There was no formal correction for multiple comparisons. Test for Arm C vs. Arm A was carried out at one-sided 10% alpha.|Fisher Exact||The difference between arms was calculated as Arm C minus Arm A.|Null hypothesis (H0): There is no difference between either of the faricimab treatment arms (Arms B and C) and the active comparator ranibizumab treatment arm (Arm A). The alternative hypothesis (Ha): Either of the faricimab treatment arms (Arm B or C) is different from the ranibizumab treatment arm (Arm A).||11.33|-5.02|0.7437
72339304|NCT02699450|144202177|SUPERIORITY||Difference in Percentage of Participants|2.02||||1|TWO_SIDED|80.0|-8.6|12.64||There was no formal correction for multiple comparisons. Test for Arm C vs. Arm A was carried out at one-sided 10% alpha.|Fisher Exact||The difference between arms was calculated as Arm C minus Arm A.|Null hypothesis (H0): There is no difference between either of the faricimab treatment arm (Arm C) and the active comparator ranibizumab treatment arm (Arm A). The alternative hypothesis (Ha): The faricimab treatment arms (Arm C) is different from the ranibizumab treatment arm (Arm A).||12.64|-8.60|1.0000
72339305|NCT01344629|144202216|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence between T80/A 5mg FDC tablet and T80mg / A5 mg tablet in concomitant use|Test/Reference Ratio of the mean x 100|100.9||||||90.0|97.7|104.2||No statistical test|ANOVA|||||104.2|97.7|
72339306|NCT01344629|144202217|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence between T80/A 5mg FDC tablet and T80mg / A5 mg tablet in concomitant use|Test/Reference Ratio of the mean x 100|97.2||||||90.0|87.2|108.3||No statistical test|ANOVA|||||108.3|87.2|
72339307|NCT01344629|144202218|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence between T80/A 5mg FDC tablet and T80mg / A5 mg tablet in concomitant use|Test/Reference Ratio of the mean x 100|101.7||||||90.0|98.3|105.2||No statistical test|ANOVA|||||105.2|98.3|
72339308|NCT01344629|144202219|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence between T80/A 5mg FDC tablet and T80mg / A5 mg tablet in concomitant use|Test/Reference Ratio of the mean x 100|110.1||||||90.0|95.8|124.4||No statistical test|ANOVA|||||124.4|95.8|
72339309|NCT01344629|144202220|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence between T80/A 5mg FDC tablet and T80mg / A5 mg tablet in concomitant use|Test/Reference Ratio of the mean x 100|91.4||||||90.0|85.6|97.6||No statistical test|ANOVA|||||97.6|85.6|
72339310|NCT01344629|144202221|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence between T80/A 5mg FDC tablet and T80mg / A5 mg tablet in concomitant use|Test/Reference Ratio of the mean x 100|109.4||||||90.0|102.4|116.8||No statistical test|ANOVA|||||116.8|102.4|
72339311|NCT01344629|144202222|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence between T80/A 5mg FDC tablet and T80mg / A5 mg tablet in concomitant use|Test/Reference Ratio of the mean x 100|109.0||||||90.0|101.5|117.1||No statistical test|ANOVA|||||117.1|101.5|
72339312|NCT04063787|144202255|EQUIVALENCE|The null hypothesis is the difference is zero. Thus the equivalence margin equals zero.|Mean Difference (Final Values)|0.408|STANDARD_DEVIATION|1.05||0.012|TWO_SIDED||||||t-test, 2 sided|Paired t-test||Compare before and after use of Fist Assist||||0.012
72339313|NCT05545644|144202259|SUPERIORITY||Hedges g|0.48|STANDARD_ERROR_OF_MEAN|0.48|||TWO_SIDED|||||Given the small sample size, we relied more heavily on effect size calculations (Hedges g adjusted for small sample bias).||||||||
72339314|NCT05545644|144202260|SUPERIORITY||Hedges g|0.37|STANDARD_ERROR_OF_MEAN|0.45|||TWO_SIDED|||||Given the small sample size, we relied more heavily on effect size calculations (Hedges g adjusted for small sample bias).||||||||
72339315|NCT05545644|144202261|SUPERIORITY||Hedges g|0.04|STANDARD_ERROR_OF_MEAN|0.42|||TWO_SIDED|||||Given the small sample size, we relied more heavily on effect size calculations (Hedges g adjusted for small sample bias).||||||||
72339316|NCT05545644|144202261|SUPERIORITY|Given the small sample size, we relied more heavily on effect size calculations (Hedges g adjusted for small sample bias).|Mean Difference (Final Values)|0.19|||||TWO_SIDED||||||||||Hedges g = .04; SE = .42|||
72339317|NCT05545644|144202262|SUPERIORITY||Hedges g|0.44|STANDARD_ERROR_OF_MEAN|0.63|||TWO_SIDED|||||Given the small sample size, we relied more heavily on effect size calculations (Hedges g adjusted for small sample bias).||||||||
72339318|NCT01643876|144202265|SUPERIORITY_OR_OTHER||Median Difference (Net)|-1.5|||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: in individuals with denture stomatitis, there are no difference in the extent of palatal inflammation before and 3 months after palatal brushing. Assuming that the minimal practically important pre/post difference in the mean change score is 20 percent and the standard deviation of the distribution of the change in score is 0.8, a sample size of 44 participants is required to ensure a power of 90 % of rejecting the null hypothesis if it is indeed false.||||<0.0001
72339319|NCT01643876|144202266|SUPERIORITY_OR_OTHER||Median Difference (Net)|-57.5|||<|0.05|||||||Wilcoxon (Mann-Whitney)|||Null Hypothesis: in individuals with denture stomatitis, there are no difference in the number of Candida Colony-Forming Units (CFUs), before and 3 months after palatal brushing.||||<0.05
72339320|NCT02469714|144202267|SUPERIORITY||Mean Difference (Final Values)|0.66||||0.04|TWO_SIDED||||||ANCOVA|||Between group comparison of total scheduled appointments from 1-13 months||||.04
72339321|NCT02469714|144202267|SUPERIORITY||Mean Difference (Final Values)|0.61||||0.008|TWO_SIDED||||||ANCOVA|||Between group comparison of total achieved appointments from 1-13 months||||.008
72339322|NCT02469714|144202268|SUPERIORITY||Mean Difference (Final Values)|0.99||||0.135|TWO_SIDED||||||ANCOVA|||This statistical analysis applies from baseline to 12 month.||||.135
72339323|NCT02469714|144202269|SUPERIORITY||Mean Difference (Final Values)|0.99||||0.077|TWO_SIDED||||||ANCOVA|||This statistical analysis applies from baseline to 12 month.||||.077
72339324|NCT02469714|144202270|SUPERIORITY||Mean Difference (Final Values)|1.0||||0.0005|TWO_SIDED||||||ANCOVA|||This statistical analysis applies from baseline to 12 month.||||.0005
72339325|NCT02469714|144202271|SUPERIORITY||Mean Difference (Final Values)|1.05||||0.06|TWO_SIDED||||||ANCOVA|||This statistical analysis applies from baseline to 12 month.||||.060
72339326|NCT02469714|144202272|SUPERIORITY||Mean Difference (Final Values)|1.03||||0.073|TWO_SIDED||||||ANCOVA|||This statistical analysis applies from baseline to 12 month.||||.073
72339327|NCT02469714|144202273|SUPERIORITY||Mean Difference (Final Values)|0.93||||0.34|TWO_SIDED||||||ANCOVA|||This statistical analysis applies from baseline to 12 month.||||.34
72339328|NCT02469714|144202274|SUPERIORITY||Mean Difference (Final Values)|0.95||||0.21|TWO_SIDED||||||ANCOVA|||This statistical analysis applies from baseline to 12 month.||||.21
72339329|NCT03343080|144202292|SUPERIORITY|||||||0.776|||||||Wilcoxon (Mann-Whitney)|||||||0.776
72339330|NCT03343080|144202293|SUPERIORITY|||||||0.296|||||||t-test, 2 sided|||4 hours post-extubation||||0.296
72339331|NCT01241760|144202294|NON_INFERIORITY_OR_EQUIVALENCE|If the lower limit of the 95% confidence interval of the difference in proportions was above the pre-determined non-inferiority margin of -11%, non-inferiority was established.|Difference in proportion of response, %|1.5||||||95.0|-4.9|12.0|||Regression, Logistic|The 95% confidence interval of the difference in proportions was estimated using a logistic regression model.|Observed data|||12|-4.9|
72339332|NCT01636713|144202309|SUPERIORITY_OR_OTHER||Least squares mean difference|0.151|||<|0.001|TWO_SIDED|95.0|0.11|0.191|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least squares mean difference=UMEC/VI 62.5/25 µg minus Placebo.|||0.191|0.110|<0.001
72339333|NCT01636713|144202309|SUPERIORITY_OR_OTHER||Least squares mean difference|0.216|||<|0.001|TWO_SIDED|95.0|0.175|0.257|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least squares mean difference= UMEC/VI 125/25 µg minus Placebo.|||0.257|0.175|<0.001
72339334|NCT03780959|144202312|SUPERIORITY|||||||0.003|||||||Mantel Haenszel|Stratified by study center and the number of active joints at randomization||||||0.0030
72339335|NCT03780959|144202313|SUPERIORITY|||||||0.0001|||||||Log Rank|||||||0.0001
72339336|NCT03689244|144202337|SUPERIORITY||Ratio of Geometric LS mean|0.95||||0.412|TWO_SIDED|95.0|0.84|1.07|||ANCOVA|||Ratio of Geometric mean of Selexipag to Placebo was reported.||1.07|0.84|0.412
72339337|NCT02698371|144202340|EQUIVALENCE|alpha value of 0.05 was considered||||||0.025|||||||McNemar|||H0 - Bonding to NCCLs with FBDC by Self-Etch mode (FBDC-SE; G1) and MM adhesives by SE mode (MM-SE; G4G6) result in similar (no significant differences) clinical (aesthetic, functional and biologic) behaviour/performance between baseline and 24 month follow-up;||||0.025
72339338|NCT02698371|144202340|EQUIVALENCE|alpha value of 0.05 was considered||||||0.189|||||||Wilcoxon (Mann-Whitney)|||H0 - Bonding to NCCLs with FBDC-SE (G1) and MM-SE(G4G6) result in similar restorations (aesthetic, functional and biologic) success rates;||||0.189
72339339|NCT02698371|144202340|EQUIVALENCE|alpha value of 0.05 was considered||||||0.189|||||||Wilcoxon (Mann-Whitney)|||H0 - Bonding to NCCLs with FBDC-SE (G1) and MM-SE (G4G6) adhesives result in similar restoration retention rates;||||0.189
72339340|NCT02698371|144202340|EQUIVALENCE|alpha value of 0.05 was considered||||||0.025|||||||McNemar|||H0 - Bonding to NCCLs with FBDC by SE and enamel etching mode (FBDC-SE-EE; G2) and MM adhesives by Etch-and-Rinse mode (MM-ER; G3G5) result in similar (no significant differences) clinical (aesthetic, functional and biologic) behaviour/performance from baseline to 24 month follow-up;||||0.025
72339341|NCT02698371|144202340|EQUIVALENCE|alpha value of 0.05 was considered||||||0.747|||||||Wilcoxon (Mann-Whitney)|||H0 - Bonding to NCCLs with FBDC-SE-EE (G2) and MM-ER (G3G5) result in similar restorations (aesthetic, functional and biologic) success rates;||||0.747
72339342|NCT02698371|144202340|EQUIVALENCE|alpha value of 0.05 was considered||||||0.747|||||||Wilcoxon (Mann-Whitney)|||H0 - Bonding to NCCLs with FBDC-SE-EE (G2) and MM-ER (G3G5) result in similar restoration retention rates;||||0.747
72339343|NCT02698371|144202340|EQUIVALENCE|alpha value of 0.05 was considered||||||0.07|||||||Kruskal-Wallis|||H0 - Bonding to NCCLs with FBDC (G1G2) or FBU (G3G4), DC adhesives, and ADU (G5G6) light-curing adhesive, with SE or SE-ER/ER modes result in similar (no significant differences) clinical (aesthetic, functional and biologic) behaviour/performance;||||0.070
72339344|NCT02698371|144202340|EQUIVALENCE|alpha value of 0.05 was considered||||||0.07||||||Applied for rows/Categories- Acceptance Vs Not Acceptance Functional-FDI comparison between G1G2 and G3G4 and G5G6 Arms success rate from baseline to 24 month recall. For Esthetic and Biological-FDI comparison p values were \> 0.05. Adjusted P-values.|Kruskal-Wallis|||H0 - Bonding to NCCLs with FBDC (G1G2) or FBU (G3G4) and ADU (G5G6) light-curing adhesive, with SE or SE-ER/ER modes result in similar restorations (aesthetic, functional and biologic) success rates;||||0.070
72339345|NCT02698371|144202340|EQUIVALENCE|alpha value of 0.05 was considered||||||0.07||||||Applied for rows/Categories- Acceptance Vs Not Acceptance Retention-FDI comparison between G1G2 and G3G4 and G5G6 Arms retention rate from baseline to 24 month recall. Adjusted P-values.|Kruskal-Wallis|||H0 - Bonding to NCCLs with FBDC (G1G2) or FBU (G3G4) and ADU (G5G6) light-curing adhesive, with SE or SE-ER/ER modes result in similar restoration retention rates;||||0.070
72339346|NCT02698371|144202341|EQUIVALENCE|alpha value of 0.05 was considered||||||0.025|||||||McNemar|||H0 - Bonding to NCCLs with FBDC by Self-Etch mode (FBDC-SE; G1) and MM adhesives by SE mode (MM-SE; G4G6) result in similar (no significant differences) clinical (aesthetic, functional and biologic) behaviour/performance;||||0.025
72339347|NCT02698371|144202341|EQUIVALENCE|alpha value of 0.05 was considered||||||0.189|||||||Wilcoxon (Mann-Whitney)|||H0 - Bonding to NCCLs with FBDC-SE (G1) and MM-SE(G4G6) result in similar restorations (aesthetic, functional and biologic) success rates;||||0.189
72339348|NCT02698371|144202341|EQUIVALENCE|alpha value of 0.05 was considered||||||0.189|||||||Wilcoxon (Mann-Whitney)|||H0 - Bonding to NCCLs with FBDC-SE (G1) and MM-SE (G4G6) adhesives result in similar restoration retention rates;||||0.189
72339349|NCT02698371|144202341|EQUIVALENCE|alpha value of 0.05 was considered||||||0.025|||||||McNemar|||H0 - Bonding to NCCLs with FBDC by SE and enamel etching mode (FBDC-SE-EE; G2) and MM adhesives by Etch-and-Rinse mode (MM-ER; G3G5) result in similar (no significant differences) clinical (aesthetic, functional and biologic) behaviour/performance;||||0.025
72339350|NCT02698371|144202341|EQUIVALENCE|alpha value of 0.05 was considered||||||0.154|||||||Wilcoxon (Mann-Whitney)|||H0 - Bonding to NCCLs with FBDC-SE-EE (G2) and MM-ER (G3G5) result in similar restorations (aesthetic, functional and biologic) success rates;||||0.154
72339351|NCT02698371|144202341|EQUIVALENCE|alpha value of 0.05 was considered||||||0.747|||||||Wilcoxon (Mann-Whitney)|||H0 - Bonding to NCCLs with FBDC-SE-EE (G2) and MM-ER (G3G5) result in similar restoration retention rates;||||0.747
72339352|NCT02698371|144202341|EQUIVALENCE|alpha value of 0.05 was considered||||||0.07|||||||Kruskal-Wallis|||H0 - Bonding to NCCLs with FBDC (G1G2) or FBU (G3G4), DC adhesives, and ADU (G5G6) light-curing adhesive, with SE or SE-ER/ER modes result in similar (no significant differences) clinical (aesthetic, functional and biologic) behaviour/performance;||||0.070
72339353|NCT02698371|144202341|EQUIVALENCE|alpha value of 0.05 was considered||||||0.07|||||||Kruskal-Wallis|||H0 - Bonding to NCCLs with FBDC (G1G2) or FBU (G3G4) and ADU (G5G6) light-curing adhesive, with SE or SE-ER/ER modes result in similar restorations (aesthetic, functional and biologic) success rates;||||0.070
72339354|NCT02698371|144202341|EQUIVALENCE|alpha value of 0.05 was considered||||||0.07|||||||Kruskal-Wallis|||H0 - Bonding to NCCLs with FBDC (G1G2) or FBU (G3G4) and ADU (G5G6) light-curing adhesive, with SE or SE-ER/ER modes result in similar restoration retention rates;||||0.070
72339355|NCT02698371|144202342|EQUIVALENCE|An alpha value of 0.05 was considered||||||1||||||Applied for rows/Categories- Acceptance Vs Not Acceptance Esthetic of FDI and of USPHS comparison; Applied to G1G2; G3G4 and G5G6 separately.|Chi-squared|||H0: FDI or USPHS criteria Esthetic outcomes not differ at 24th month follow-up regarding Bonding to NCCLs with FBDC (G1G2) or FBU (G3G4) and ADU (G5G6) adhesive, with SE or SE-ER/ER modes.||||1.000
72339356|NCT02698371|144202342|EQUIVALENCE|An alpha value of 0.05 was considered||||||1||||||Applied for rows/Categories- Acceptance Vs Not Acceptance Functional of FDI and of USPHS comparison; Applied to G1G2; G3G4 and G5G6 separately.|Chi-squared|||H0: FDI or USPHS criteria Functional outcomes not differ at 24th month follow-up regarding Bonding to NCCLs with FBDC (G1G2) or FBU (G3G4) and ADU (G5G6) adhesive, with SE or SE-ER/ER modes.||||1.000
72339357|NCT02698371|144202342|EQUIVALENCE|An alpha value of 0.05 was considered||||||0.998||||||Applied for rows/Categories- Acceptance Vs Not Acceptance Biologic FDI and of USPHS comparison; Applied to G1G2; G3G4 and G5G6 separately.|Chi-squared|||H0: FDI or USPHS criteria Biological outcomes not differ at 24th month follow-up regarding Bonding to NCCLs with FBDC (G1G2) or FBU (G3G4) and ADU (G5G6) adhesive, with SE or SE-ER/ER modes.||||0.998
72339358|NCT02698371|144202343|EQUIVALENCE|alpha value of 0.05 was considered||||||0.029||||||Applied for all rows/Categories (graded on a 5-point scale) Surface Luster-FDI comparison between G1 and G4G6 Arms performance from baseline to 24 month recall.|Wilcoxon (Mann-Whitney)|||H0 - Bonding to NCCLs with FBDC by Self-Etch mode (FBDC-SE; G1) and MM adhesives by SE mode (MM-SE; G4G6) result in similar (no significant differences) Surface Luster Performance at 24 Month Follow-up recall.||||0.029
72339359|NCT02698371|144202343|EQUIVALENCE|alpha value of 0.05 was considered||||||0.002||||||Applied for all rows/Categories (graded on a 5-point scale) Surface Luster-FDI comparison between G2 and G3G5 Arms performance from baseline to 24 month recall.|Wilcoxon (Mann-Whitney)|||H0 - Bonding to NCCLs with FBDC by SE and enamel etching mode (FBDC-SE-EE; G2) and MM adhesives by Etch-and-Rinse mode (MM-ER; G3G5) result in similar (no significant differences) Surface Luster performance at 24 Month Follow-up recall;||||0.002
72339360|NCT02698371|144202343|EQUIVALENCE|alpha value of 0.05 was considered||||||0.618||||||Applied for all rows/Categories (graded on a 5-point scale) Surface Luster-FDI comparison between G1G2 and G3G4 and G5G6 Arms performance from baseline to 24 month recall. P-value adjusted.|Kruskal-Wallis|||H0 - Bonding to NCCLs with FBDC (G1G2) or FBU (G3G4), DC adhesives, and ADU (G5G6) light-curing adhesive, with SE or SE-ER/ER modes result in similar (no significant differences) Surface Luster performance at 24 Month Follow-up recall.||||0.618
72339361|NCT02698371|144202344|EQUIVALENCE|An alpha value of 0.05 was considered||||||0.009||||||Applied for all rows/Categories (graded on a 5-point scale) Staining Margin-FDI comparison between G1 and G4G6 Arms performance from baseline to 24 month recall.|Wilcoxon (Mann-Whitney)|||H0 - Bonding to NCCLs with FBDC by Self-Etch mode (FBDC-SE; G1) and MM adhesives by SE mode (MM-SE; G4G6) result in similar (no significant differences) Staining Margin Performance at 24 Month Follow-up recall.||||0.009
72339362|NCT02698371|144202344|EQUIVALENCE|An alpha value of 0.05 was considered||||||0.059||||||Applied for all rows/Categories (graded on a 5-point scale) Staining Margin-FDI comparison between G2 and G3G5 Arms performance from baseline to 24 month recall.|Wilcoxon (Mann-Whitney)|||H0 - Bonding to NCCLs with FBDC by SE and enamel etching mode (FBDC-SE-EE; G2) and MM adhesives by Etch-and-Rinse mode (MM-ER; G3G5) result in similar (no significant differences) Staining Margin Performance at 24 Month Follow-up recall.||||0.059
72339363|NCT02698371|144202344|EQUIVALENCE|An alpha value of 0.05 was considered||||||0.829||||||Applied for all rows/Categories (graded on a 5-point scale) Staining Margin-FDI comparison between G1G2 and G3G4 and G5G6 Arms performance from baseline to 24 month recall. P-value adjusted.|Kruskal-Wallis|||H0 - Bonding to NCCLs with FBDC (G1G2) or FBU (G3G4), DC adhesives, and ADU (G5G6) light-curing adhesive, with SE or SE-ER/ER modes result in similar (no significant differences) Staining Margin performance at 24 month follow-up recall.||||0.829
72339364|NCT02698371|144202345|EQUIVALENCE|An alpha value of 0.05 was considered|||||<|0.001||||||Applied for all rows/Categories (graded on a 5-point scale) Colour Stability-FDI comparison between G1 and G4G6 Arms performance from baseline to 24 month recall.|Wilcoxon (Mann-Whitney)|||H0 - Bonding to NCCLs with FBDC by Self-Etch mode (FBDC-SE; G1) and MM adhesives by SE mode (MM-SE; G4G6) result in similar (no significant differences) Colour Stability performance at 24 month follow-up recall.||||<0.001
72339365|NCT02698371|144202345|EQUIVALENCE|An alpha value of 0.05 was considered|||||<|0.001||||||Applied for all rows/Categories (graded on a 5-point scale) of Colour Stability-FDI comparison between G2 and G3G5 Arms performance from baseline to 24 month recall.|Wilcoxon (Mann-Whitney)|||H0 - Bonding to NCCLs with FBDC by SE and enamel etching mode (FBDC-SE-EE; G2) and MM adhesives by Etch-and-Rinse mode (MM-ER; G3G5) result in similar (no significant differences) Colour Stability performance at 24 month follow-up recall.||||<0.001
72339366|NCT02698371|144202345|EQUIVALENCE|An alpha value of 0.05 was considered||||||0.064||||||Applied for all rows/Categories (graded on a 5-point scale) of Colour Stability-FDI comparison between G1G2 and G3G4 and G5G6 Arms performance from baseline to 24 month recall. P-value adjusted.|Kruskal-Wallis|||H0 - Bonding to NCCLs with FBDC (G1G2) or FBU (G3G4), DC adhesives, and ADU (G5G6) light-curing adhesive, with SE or SE-ER/ER modes result in similar (no significant differences) Colour Stability performance at 24 month follow-up recall.||||0.064
72339367|NCT02698371|144202346|EQUIVALENCE|An alpha value of 0.05 was considered||||||0.006||||||Applied for all rows/Categories (graded on a 5-point scale) of Fractures and Retention-FDI comparison between G1 and G4G6 Arms performance from baseline to 24 month recall.|Wilcoxon (Mann-Whitney)|||H0 - Bonding to NCCLs with FBDC by Self-Etch mode (FBDC-SE; G1) and MM adhesives by SE mode (MM-SE; G4G6) result in similar (no significant differences) Fractures and Retention performance at 24 month follow-up recall.||||0.006
72339368|NCT02698371|144202346|EQUIVALENCE|An alpha value of 0.05 was considered||||||0.02||||||Applied for all rows/Categories (graded on a 5-point scale) of Fractures and Retention-FDI comparison between G2 and G3G5 Arms performance from baseline to 24 month recall.|Wilcoxon (Mann-Whitney)|||H0 - Bonding to NCCLs with FBDC by SE and enamel etching mode (FBDC-SE-EE; G2) and MM adhesives by Etch-and-Rinse mode (MM-ER; G3G5) result in similar (no significant differences) Fractures and Retention performance at 24 month follow-up recall.||||0.020
72339369|NCT02698371|144202346|EQUIVALENCE|An alpha value of 0.05 was considered||||||0.054||||||Applied for all rows/Categories (graded on a 5-point scale) of Fractures and Retention-FDI comparison between G1G2 and G3G4 and G5G6 Arms performance from baseline to 24 month recall. P-value adjusted.|Kruskal-Wallis|||H0 - Bonding to NCCLs with FBDC (G1G2) or FBU (G3G4), DC adhesives, and ADU (G5G6) light-curing adhesive, with SE or SE-ER/ER modes result in similar (no significant differences) Fractures and Retention performance at 24 month follow-up recall.||||0.054
72339370|NCT02698371|144202347|EQUIVALENCE|An alpha value of 0.05 was considered||||||0.01||||||Applied for all rows/Categories (graded on a 5-point scale) of Marginal Adaptation-FDI comparison between G1 and G4G6 Arms performance from baseline to 24 month recall.|Wilcoxon (Mann-Whitney)|||H0 - Bonding to NCCLs with FBDC by Self-Etch mode (FBDC-SE; G1) and MM adhesives by SE mode (MM-SE; G4G6) result in similar (no significant differences) Marginal Adaptation performance at 24 month follow-up recall.||||0.010
72339371|NCT02698371|144202347|EQUIVALENCE|An alpha value of 0.05 was considered||||||0.071||||||Applied for all rows/Categories (graded on a 5-point scale) of Marginal Adaptation-FDI comparison between G2 and G3G5 Arms performance from baseline to 24 month recall.|Wilcoxon (Mann-Whitney)|||H0 - Bonding to NCCLs with FBDC by SE and enamel etching mode (FBDC-SE-EE; G2) and MM adhesives by Etch-and-Rinse mode (MM-ER; G3G5) result in similar (no significant differences) Marginal Adaptation performance at 24 month follow-up recall.||||0.071
72339372|NCT02698371|144202347|EQUIVALENCE|An alpha value of 0.05 was considered||||||0.898||||||Applied for all rows/Categories (graded on a 5-point scale) of Marginal Adaptation-FDI comparison between G1G2 and G3G4 and G5G6 Arms performance from baseline to 24 month recall. P-value adjusted.|Kruskal-Wallis|||H0 - Bonding to NCCLs with FBDC (G1G2) or FBU (G3G4), DC adhesives, and ADU (G5G6) light-curing adhesive, with SE or SE-ER/ER modes result in similar (no significant differences) Marginal Adaptation performance at 24 month follow-up recall.||||0.898
72339373|NCT02698371|144202348|EQUIVALENCE|An alpha value of 0.05 was considered||||||0.317||||||Applied for all rows/Categories (graded on a 5-point scale) of Postoperative Hypersensibility, Tooth Vitality-FDI comparison between G1 and G4G6 Arms performance from baseline to 24 month recall.|Wilcoxon (Mann-Whitney)|||H0 - Bonding to NCCLs with FBDC by Self-Etch mode (FBDC-SE; G1) and MM adhesives by SE mode (MM-SE; G4G6) result in similar (no significant differences) Postoperative Hypersensibility, Tooth Vitality performance at 24 month follow-up recall.||||0.317
72339374|NCT02698371|144202348|EQUIVALENCE|An alpha value of 0.05 was considered||||||0.18||||||Applied for all rows/Categories (graded on a 5-point scale) of Postoperative Hypersensibility, Tooth Vitality-FDI comparison between G2 and G3G5 Arms performance from baseline to 24 month recall.|Wilcoxon (Mann-Whitney)|||H0 - Bonding to NCCLs with FBDC by SE and enamel etching mode (FBDC-SE-EE; G2) and MM adhesives by Etch-and-Rinse mode (MM-ER; G3G5) result in similar (no significant differences) Postoperative Hypersensibility, Tooth Vitality performance at 24 month follow-up recall.||||0.180
72339375|NCT02698371|144202348|EQUIVALENCE|An alpha value of 0.05 was considered||||||0.918||||||Applied for all rows/Categories (graded on a 5-point scale) of Postoperative Hypersensibility, Tooth Vitality-FDI comparison between G1G2 and G3G4 and G5G6 Arms performance from baseline to 24 month recall. P-value adjusted.|Kruskal-Wallis|||H0 - Bonding to NCCLs with FBDC (G1G2) or FBU (G3G4), DC adhesives, and ADU (G5G6) light-curing adhesive, with SE or SE-ER/ER modes result in similar (no significant differences) Postoperative Hypersensibility, Tooth Vitality performance at 24 month follow-up recall.||||0.918
72339376|NCT02698371|144202349|EQUIVALENCE|An alpha value of 0.05 was considered||||||0.317||||||Applied for all rows/Categories (graded on a 5-point scale) of Recurrence of Caries, Erosion, Abfraction-FDI comparison between G1 and G4G6 Arms performance from baseline to 24 month recall.|Wilcoxon (Mann-Whitney)|||H0 - Bonding to NCCLs with FBDC by Self-Etch mode (FBDC-SE; G1) and MM adhesives by SE mode (MM-SE; G4G6) result in similar (no significant differences) Recurrence of Caries, Erosion, Abfraction performance at 24 month follow-up recall.||||0.317
72339377|NCT02698371|144202349|EQUIVALENCE|An alpha value of 0.05 was considered||||||0.317||||||Applied for all rows/Categories (graded on a 5-point scale) of Recurrence of Caries, Erosion, Abfraction-FDI comparison between G2 and G3G5 Arms performance from baseline to 24 month recall.|Wilcoxon (Mann-Whitney)|||H0 - Bonding to NCCLs with FBDC by SE and enamel etching mode (FBDC-SE-EE; G2) and MM adhesives by Etch-and-Rinse mode (MM-ER; G3G5) result in similar (no significant differences) Recurrence of Caries, Erosion, Abfraction performance at 24 month follow-up recall.||||.317
72339378|NCT02698371|144202349|EQUIVALENCE|An alpha value of 0.05 was considered||||||0.575||||||Applied for all rows/Categories (graded on a 5-point scale) of Recurrence of Caries, Erosion \& Abfraction-FDI comparison between G1G2 and G3G4 and G5G6 Arms performance from baseline to 24 month recall. P-value adjusted.|Kruskal-Wallis|||H0 - Bonding to NCCLs with FBDC (G1G2) or FBU (G3G4), DC adhesives, and ADU (G5G6) light-curing adhesive, with SE or SE-ER/ER modes result in similar (no significant differences) Recurrence of Caries, Erosion, Abfraction performance at 24 month follow-up recall.||||0.575
72339379|NCT02698371|144202350|EQUIVALENCE|An alpha value of 0.05 was considered||||||0.02||||||Applied for all rows/Categories (graded on a 5-point scale) of Tooth Integrity (enamel cracks)-FDI comparison between G1 and G4G6 Arms performance from baseline to 24 month recall.|Wilcoxon (Mann-Whitney)|||H0 - Bonding to NCCLs with FBDC by Self-Etch mode (FBDC-SE; G1) and MM adhesives by SE mode (MM-SE; G4G6) result in similar (no significant differences) Tooth Integrity (enamel cracks) performance at 24 month follow-up recall.||||0.020
72339380|NCT02698371|144202350|EQUIVALENCE|An alpha value of 0.05 was considered||||||0.107||||||Applied for all rows/Categories (graded on a 5-point scale) of Tooth Integrity (enamel cracks)-FDI comparison between G2 and G3G5 Arms performance from baseline to 24 month recall.|Wilcoxon (Mann-Whitney)|||H0 - Bonding to NCCLs with FBDC by SE and enamel etching mode (FBDC-SE-EE; G2) and MM adhesives by Etch-and-Rinse mode (MM-ER; G3G5) result in similar (no significant differences) Tooth Integrity (enamel cracks) performance at 24 month follow-up recall.||||0.107
72339381|NCT02698371|144202350|EQUIVALENCE|An alpha value of 0.05 was considered||||||0.592||||||Applied for all rows/Categories (graded on a 5-point scale) of Tooth Integrity (enamel cracks)-FDI comparison between G1G2 and G3G4 and G5G6 Arms performance from baseline to 24 month recall. P-value adjusted.|Kruskal-Wallis|||H0 - Bonding to NCCLs with FBDC (G1G2) or FBU (G3G4), DC adhesives, and ADU (G5G6) light-curing adhesive, with SE or SE-ER/ER modes result in similar (no significant differences) Tooth Integrity (enamel cracks) performance at 24 month follow-up recall.||||0.592
72339382|NCT02698371|144202351|EQUIVALENCE|An alpha value of 0.05 was considered||||||1||||||Applied for rows/categories alfa/bravo/charlie of Surface Staining-USPHS comparison between G1 and G4G6 Arms performance from baseline to 24 month recall.|Wilcoxon (Mann-Whitney)|||H0 - Bonding to NCCLs with FBDC by Self-Etch mode (FBDC-SE; G1) and MM adhesives by SE mode (MM-SE; G4G6) result in similar (no significant differences) Surface Staining performance at 24 month follow-up recall.||||1.000
72339383|NCT02698371|144202351|EQUIVALENCE|An alpha value of 0.05 was considered||||||1||||||Applied for rows/categories alfa/bravo/charlie of Surface Staining-USPHS comparison between G2 and G3G5 Arms performance from baseline to 24 month recall.|Wilcoxon (Mann-Whitney)|||H0 - Bonding to NCCLs with FBDC by SE and enamel etching mode (FBDC-SE-EE; G2) and MM adhesives by Etch-and-Rinse mode (MM-ER; G3G5) result in similar (no significant differences) Surface Staining performance at 24 month follow-up recall.||||1.000
72339384|NCT02698371|144202351|EQUIVALENCE|An alpha value of 0.05 was considered||||||1||||||Applied for rows/categories alfa/bravo/charlie of Surface Staining-USPHS comparison between G1G2 and G3G4 and G5G6 Arms performance from baseline to 24 month recall. P-value adjusted.|Kruskal-Wallis|||H0 - Bonding to NCCLs with FBDC (G1G2) or FBU (G3G4), DC adhesives, and ADU (G5G6) light-curing adhesive, with SE or SE-ER/ER modes result in similar (no significant differences) Surface Staining performance at 24 month follow-up recall.||||1.000
72339385|NCT02698371|144202352|EQUIVALENCE|An alpha value of 0.05 was considered||||||0.011||||||Applied for rows/categories alfa/bravo/charlie of Marginal Discoloration-USPHS comparison between G1 and G4G6 Arms performance from baseline to 24 month recall.|Wilcoxon (Mann-Whitney)|||H0 - Bonding to NCCLs with FBDC by Self-Etch mode (FBDC-SE; G1) and MM adhesives by SE mode (MM-SE; G4G6) result in similar (no significant differences) Marginal Discoloration performance at 24 month follow-up recall.||||0.011
72339386|NCT02698371|144202352|EQUIVALENCE|An alpha value of 0.05 was considered||||||0.034||||||Applied for rows/categories alfa/bravo/charlie of Marginal Discoloration-USPHS comparison between G2 and G3G5 Arms performance from baseline to 24 month recall.|Wilcoxon (Mann-Whitney)|||H0 - Bonding to NCCLs with FBDC by SE and enamel etching mode (FBDC-SE-EE; G2) and MM adhesives by Etch-and-Rinse mode (MM-ER; G3G5) result in similar (no significant differences) Marginal Discoloration performance at 24 month follow-up recall.||||0.034
72428381|NCT01327547|144367743|SUPERIORITY_OR_OTHER||Difference in LS Mean|-31.86||||0.5571|TWO_SIDED|95.0|-138.93|75.21|||ANCOVA|||The above analysis is for CD8+ cells at Week 144. Results are from an ANCOVA model with change from baseline as the response variable and the following fixed effect model terms: treatment (Maraviroc or placebo), baseline value of the response variable, hepatitis B virus status (HBV), Protease inhibitor (PI)-based regimen.||75.21|-138.93|0.5571
72339387|NCT02698371|144202352|EQUIVALENCE|An alpha value of 0.05 was considered||||||0.885||||||Applied for rows/categories alfa/bravo/charlie of Marginal Discoloration-USPHS comparison between G1G2 and G3G4 and G5G6 Arms performance from baseline to 24 month recall. P-value adjusted.|Kruskal-Wallis|||H0 - Bonding to NCCLs with FBDC (G1G2) or FBU (G3G4), DC adhesives, and ADU (G5G6) light-curing adhesive, with SE or SE-ER/ER modes result in similar (no significant differences) Marginal Discoloration performance at 24 month follow-up recall.||||0.885
72339388|NCT02698371|144202353|EQUIVALENCE|An alpha value of 0.05 was considered||||||1||||||Applied for rows/categories alfa/bravo/charlie of Color Match-USPHS comparison between G1 and G4G6 Arms performance from baseline to 24 month recall.|Wilcoxon (Mann-Whitney)|||H0 - Bonding to NCCLs with FBDC by Self-Etch mode (FBDC-SE; G1) and MM adhesives by SE mode (MM-SE; G4G6) result in similar (no significant differences) Color Match performance at 24 month follow-up recall.||||1.000
72339389|NCT02698371|144202353|EQUIVALENCE|An alpha value of 0.05 was considered||||||0.317||||||Applied for rows/categories alfa/bravo/charlie of Color Match-USPHS comparison between G2 and G3G5 Arms performance from baseline to 24 month recall.|Wilcoxon (Mann-Whitney)|||H0 - Bonding to NCCLs with FBDC by SE and enamel etching mode (FBDC-SE-EE; G2) and MM adhesives by Etch-and-Rinse mode (MM-ER; G3G5) result in similar (no significant differences) Color Match performance at 24 month follow-up recall.||||0.317
72339390|NCT02698371|144202353|EQUIVALENCE|An alpha value of 0.05 was considered||||||0.403||||||Applied for rows/categories alfa/bravo/charlie of Color Match-USPHS comparison between G1G2 and G3G4 and G5G6 Arms performance from baseline to 24 month recall. P-value adjusted.|Kruskal-Wallis|||H0 - Bonding to NCCLs with FBDC (G1G2) or FBU (G3G4), DC adhesives, and ADU (G5G6) light-curing adhesive, with SE or SE-ER/ER modes result in similar (no significant differences) Color Match performance at 24 month follow-up recall.||||0.403
72339391|NCT02698371|144202354|EQUIVALENCE|An alpha value of 0.05 was considered||||||0.02||||||Applied for rows/categories alfa/bravo/charlie of Retention-USPHS comparison between G1 and G4G6 Arms performance from baseline to 24 month recall.|Wilcoxon (Mann-Whitney)|||H0 - Bonding to NCCLs with FBDC by Self-Etch mode (FBDC-SE; G1) and MM adhesives by SE mode (MM-SE; G4G6) result in similar (no significant differences) Retention performance at 24 month follow-up recall.||||0.020
72339392|NCT02698371|144202354|EQUIVALENCE|An alpha value of 0.05 was considered||||||0.02||||||Applied for rows/categories alfa/bravo/charlie of Retention-USPHS comparison between G2 and G3G5 Arms performance from baseline to 24 month recall.|Wilcoxon (Mann-Whitney)|||H0 - Bonding to NCCLs with FBDC by SE and enamel etching mode (FBDC-SE-EE; G2) and MM adhesives by Etch-and-Rinse mode (MM-ER; G3G5) result in similar (no significant differences) Retention performance at 24 month follow-up recall.||||0.020
72339393|NCT02698371|144202354|EQUIVALENCE|An alpha value of 0.05 was considered||||||0.04||||||Applied for rows/categories alfa/bravo/charlie of Retention-USPHS comparison between G1G2 and G3G4 and G5G6 Arms performance from baseline to 24 month recall. P-value adjusted.|Kruskal-Wallis|||H0 - Bonding to NCCLs with FBDC (G1G2) or FBU (G3G4), DC adhesives, and ADU (G5G6) light-curing adhesive, with SE or SE-ER/ER modes result in similar (no significant differences) Retention performance at 24 month follow-up recall.||||0.040
72339394|NCT02698371|144202355|EQUIVALENCE|An alpha value of 0.05 was considered|||||<|0.001||||||Applied for rows/categories alfa/bravo/charlie/delta of Marginal Integrity-USPHS comparison between G1 and G4G6 Arms performance from baseline to 24 month recall.|Wilcoxon (Mann-Whitney)|||H0 - Bonding to NCCLs with FBDC by Self-Etch mode (FBDC-SE; G1) and MM adhesives by SE mode (MM-SE; G4G6) result in similar (no significant differences) Marginal Integrity performance at 24 month follow-up recall.||||<0.001
72339395|NCT02698371|144202355|EQUIVALENCE|An alpha value of 0.05 was considered|||||<|0.001||||||Applied for rows/categories alfa/bravo/charlie/delta of Marginal Integrity-USPHS comparison between G2 and G3G5 Arms performance from baseline to 24 month recall.|Wilcoxon (Mann-Whitney)|||H0 - Bonding to NCCLs with FBDC by SE and enamel etching mode (FBDC-SE-EE; G2) and MM adhesives by Etch-and-Rinse mode (MM-ER; G3G5) result in similar (no significant differences) Marginal Integrity performance at 24 month follow-up recall.||||<0.001
72339396|NCT02698371|144202355|EQUIVALENCE|An alpha value of 0.05 was considered||||||0.211||||||Applied for rows/categories alfa/bravo/charlie/delta of Marginal Integrity-USPHS comparison between G1G2 and G3G4 and G5G6 Arms performance from baseline to 24 month recall. P-value adjusted.|Kruskal-Wallis|||H0 - Bonding to NCCLs with FBDC (G1G2) or FBU (G3G4), DC adhesives, and ADU (G5G6) light-curing adhesive, with SE or SE-ER/ER modes result in similar (no significant differences) Marginal Integrity performance at 24 month follow-up recall.||||0.211
72339397|NCT02698371|144202356|EQUIVALENCE|An alpha value of 0.05 was considered||||||0.102||||||Applied for rows/categories No Evidence vs Evidence of Postoperative Sensitivity-USPHS comparison between G1 and G4G6 Arms performance from baseline to 24 month recall.|Wilcoxon (Mann-Whitney)|||H0 - Bonding to NCCLs with FBDC by Self-Etch mode (FBDC-SE; G1) and MM adhesives by SE mode (MM-SE; G4G6) result in similar (no significant differences) Postoperative Sensitivity performance at 24 month follow-up recall.||||0.102
72339398|NCT02698371|144202356|EQUIVALENCE|An alpha value of 0.05 was considered||||||0.18||||||Applied for rows/categories No Evidence vs Evidence of Postoperative Sensitivity-USPHS comparison between G2 and G3G5 Arms performance from baseline to 24 month recall.|Wilcoxon (Mann-Whitney)|||H0 - Bonding to NCCLs with FBDC by SE and enamel etching mode (FBDC-SE-EE; G2) and MM adhesives by Etch-and-Rinse mode (MM-ER; G3G5) result in similar (no significant differences) Postoperative Sensitivity performance at 24 month follow-up recall.||||0.180
72339399|NCT02698371|144202356|EQUIVALENCE|An alpha value of 0.05 was considered||||||0.99||||||Applied for rows/categories No Evidence vs Evidence of Postoperative Sensitivity-USPHS comparison between G1G2 and G3G4 and G5G6 Arms performance from baseline to 24 month recall. P-value adjusted.|Kruskal-Wallis|||H0 - Bonding to NCCLs with FBDC (G1G2) or FBU (G3G4), DC adhesives, and ADU (G5G6) light-curing adhesive, with SE or SE-ER/ER modes result in similar (no significant differences) Postoperative Sensitivity performance at 24 month follow-up recall.||||0.990
72339400|NCT02698371|144202357|EQUIVALENCE|An alpha value of 0.05 was considered||||||0.157||||||Applied for rows/categories No Evidence vs Evidence of Secondary Caries-USPHS comparison between G1 and G4G6 Arms performance from baseline to 24 month recall.|Wilcoxon (Mann-Whitney)|||H0 - Bonding to NCCLs with FBDC by Self-Etch mode (FBDC-SE; G1) and MM adhesives by SE mode (MM-SE; G4G6) result in similar (no significant differences) Secondary Caries performance at 24 month follow-up recall.||||0.157
72339401|NCT02698371|144202357|EQUIVALENCE|An alpha value of 0.05 was considered||||||0.317||||||Applied for rows/categories No Evidence vs Evidence of Secondary Caries-USPHS comparison between G2 and G3G5 Arms performance from baseline to 24 month recall.|Wilcoxon (Mann-Whitney)|||H0 - Bonding to NCCLs with FBDC by SE and enamel etching mode (FBDC-SE-EE; G2) and MM adhesives by Etch-and-Rinse mode (MM-ER; G3G5) result in similar (no significant differences) Secondary Caries performance at 24 month follow-up recall.||||0.317
72339402|NCT02698371|144202357|EQUIVALENCE|An alpha value of 0.05 was considered||||||0.334||||||Applied for rows/categories No Evidence vs Evidence of Secondary Caries-USPHS comparison between G1G2 and G3G4 and G5G6 Arms performance from baseline to 24 month recall. P-value adjusted|Kruskal-Wallis|||H0 - Bonding to NCCLs with FBDC (G1G2) or FBU (G3G4), DC adhesives, and ADU (G5G6) light-curing adhesive, with SE or SE-ER/ER modes result in similar (no significant differences) Secondary Caries performance at 24 month follow-up recall.||||0.334
72339403|NCT02698371|144202358|EQUIVALENCE|An alpha value of 0.05 was considered||||||0.132||||||Applied for rows/categories No Evidence vs Evidence of Gingival Bleeding-USPHS comparison between G1 and G4G6 Arms performance from baseline to 24 month recall.|Wilcoxon (Mann-Whitney)|||H0 - Bonding to NCCLs with FBDC by Self-Etch mode (FBDC-SE; G1) and MM adhesives by SE mode (MM-SE; G4G6) result in similar (no significant differences) Gingival Bleeding performance at 24 month follow-up recall.||||0.132
72339404|NCT02698371|144202358|EQUIVALENCE|An alpha value of 0.05 was considered||||||0.257||||||Applied for rows/categories No Evidence vs Evidence of Gingival Bleeding-USPHS comparison between G2 and G3G5 Arms performance from baseline to 24 month recall.|Wilcoxon (Mann-Whitney)|||H0 - Bonding to NCCLs with FBDC by SE and enamel etching mode (FBDC-SE-EE; G2) and MM adhesives by Etch-and-Rinse mode (MM-ER; G3G5) result in similar (no significant differences) Gingival Bleeding performance at 24 month follow-up recall.||||0.257
72339405|NCT02698371|144202358|EQUIVALENCE|An alpha value of 0.05 was considered||||||0.918||||||Applied for rows/categories No Evidence vs Evidence of Gingival Bleeding-USPHS comparison between G1G2 and G3G4 and G5G6 Arms performance from baseline to 24 month recall. P-value adjusted|Kruskal-Wallis|||H0 - Bonding to NCCLs with FBDC (G1G2) or FBU (G3G4), DC adhesives, and ADU (G5G6) light-curing adhesive, with SE or SE-ER/ER modes result in similar (no significant differences) Gingival Bleeding performance at 24 month follow-up recall.||||0.918
72368349|NCT00541385|144246701|NON_INFERIORITY|The secondary efficacy analysis tested the non-inferiority of PA compared to the AL group with regard to the PCR-corrected ACPR response rate on Day 28 using a 2-sided 95% confidence interval (Newcombe Wilson score method without continuity correction) and a 10% non-inferiority margin for the EE population. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% confidence interval for the difference in 28-day PCR-corrected ACPR was not lower than 10%.|ACPR percent difference|-1.2||||0.3728|TWO_SIDED|95.0|-3.6|2.1||If non-inferiority of PA was demonstrated, the p-value associated with a superiority test was calculated based on a 2-sided Chi-Square test. If the calculated p-value was \<0.05, then the superiority of PA over AL was statistically demonstrated.|Chi-squared|||"Null hypothesis: The PCR-corrected ACPR response rate on Day 28 for the PA group is inferior to the PCR-corrected ACPR response rate for the AL group.~Was tested versus the alternative:~Alternative hypothesis: The PCR-corrected ACPR response rate on Day 28 for the PA group is not inferior to the PCR-corrected ACPR response rate for the AL group."||2.1|-3.6|0.3728
72368350|NCT04308291|144246727|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|paired t-test||||||<0.0001
72368351|NCT01499355|144246742|SUPERIORITY_OR_OTHER|||||||0.367||||||P-Value from Cox proportional hazard model, including the variable for treatment, adjusted for the covariates including region (Latin America, Asia, rest of world \[ROW\]) and renal response at Run-in Week 12 (partial and non-response).|Cox proportional hazard|||||||0.367
72368352|NCT01499355|144246742|SUPERIORITY_OR_OTHER|||||||0.283||||||P-Value from Cox proportional hazard model, including the variable for treatment, adjusted for the covariates including region (Latin America, Asia, ROW) and renal response at Run-in Week 12 (partial and non-response).|Cox proportional hazard|||||||0.283
72368353|NCT01499355|144246743|SUPERIORITY_OR_OTHER|||||||0.0486||||||Model includes the variable for treatment, adjusted for the covariates including region (Latin America, Asia, ROW) and renal response at Run-in Week 12 (partial and non-response).|Cochran-Mantel-Haenszel|||||||0.0486
72368354|NCT01499355|144246743|SUPERIORITY_OR_OTHER|||||||0.0668||||||Model includes the variable for treatment, adjusted for the covariates including region (Latin America, Asia, ROW) and renal response at Run-in Week 12 (partial and non-response).|Cochran-Mantel-Haenszel|||||||0.0668
72368355|NCT01499355|144246744|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.0628||||0.0456|TWO_SIDED|90.0|0.0081|0.4843||Model includes the variable for treatment, adjusted for the covariates including region (Latin America, Asia, ROW) and renal response at Run-in Week 12 (partial and non-response).|Regression, Logistic|||||0.4843|0.0081|0.0456
72368356|NCT01499355|144246744|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.4344||||0.5455|TWO_SIDED|90.0|0.0996|1.8941||Model includes the variable for treatment, adjusted for the covariates including region (Latin America, Asia, ROW) and renal response at Run-in Week 12 (partial and non-response).|Regression, Logistic|||||1.8941|0.0996|0.5455
72368357|NCT01499355|144246744|SUPERIORITY_OR_OTHER|||||||0.0252|||||||Cochran-Mantel-Haenszel|||||||0.0252
72368358|NCT01499355|144246744|SUPERIORITY_OR_OTHER|||||||0.2876|||||||Cochran-Mantel-Haenszel|||||||0.2876
72368359|NCT01499355|144246747|SUPERIORITY_OR_OTHER|||||||0.863|||||||Regression, Cox|||||||0.863
72368360|NCT01499355|144246747|SUPERIORITY_OR_OTHER|||||||0.769|||||||Regression, Cox|||||||0.769
72368361|NCT01499355|144246747|SUPERIORITY_OR_OTHER|||||||0.907|||||||ANCOVA|||||||0.907
72368362|NCT01499355|144246747|SUPERIORITY_OR_OTHER|||||||0.996|||||||ANCOVA|||||||0.996
72368363|NCT01526733|144246748|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean Ratio|2.15|||<|0.0001|TWO_SIDED|90.0|1.71|2.71||Comparison of Day 1 Insulin (Aspart or Lispro)-rHuPH20 versus Day 1 Insulin-sham.|Mixed Models Analysis|A mixed model with fixed effects for treatment, day, and interaction of treatment with day was performed using a compound symmetric covariance matrix.||||2.71|1.71|<0.0001
72428382|NCT01327547|144367744|SUPERIORITY_OR_OTHER||Difference in LS Mean|-56.06||||0.0153|TWO_SIDED|95.0|-101.2|-10.92|||ANCOVA||Difference in LS Mean|The above analysis is for CD38 expression on CD4 and CD8 cells at Week 48. Results are from an ANCOVA model with change from baseline as the response variable and the following fixed effect model terms: treatment (Maraviroc or placebo), baseline value of the response variable, HBV, PI-based regimen.||-10.92|-101.20|0.0153
72339406|NCT01800318|144202369|SUPERIORITY_OR_OTHER|||||||0.07|TWO_SIDED|||||RM Anova of effects of treatment groups on PIPP scores: .|ANOVA|||||||0.07
72339407|NCT01800318|144202369|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||t-test, 2 sided|Bonferroni correction||t test comparing baseline PIPP score with heel stick PIPP scores in group with 24% sucrose and sham NESAP.||||<0.05
72339408|NCT01800318|144202369|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||t-test, 2 sided|Bonferroni correction||t test comparing baseline PIPP score with heel stick PIPP scores in group with NESAP and oral water.||||<0.01
72339409|NCT01800318|144202369|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||t-test, 2 sided|Bonferroni correction||t test comparing baseline PIPP score with heel stick PIPP scores in group with 24% sucrose and NESAp combined.||||<0.05
72339410|NCT01800318|144202369|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||t-test, 2 sided|Bonferroni||t test comparing baseline PIPP score with heel stick PIPP scores in standard care group (Sham NESAP with oral water).||||<0.01
72339411|NCT01800318|144202370|SUPERIORITY_OR_OTHER|||||||0.9|TWO_SIDED||||||ANOVA|||||||0.9
72339412|NCT01800318|144202371|SUPERIORITY_OR_OTHER|||||||0.9|TWO_SIDED||||||ANOVA|||||||0.9
72339413|NCT01800318|144202373|SUPERIORITY_OR_OTHER|||||||0.008|TWO_SIDED||||||ANOVA|F4.048||||||0.008
72339414|NCT03809910|144202403|SUPERIORITY||Adjusted Mean Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.014|<|0.0001|TWO_SIDED|95.0|-0.09|-0.04||Analysis was performed using ANCOVA model with product, sequence as fixed effects, participant as a random effect and two baseline terms as covariates;1-participant-level baseline score,2-period level baseline minus the participant-level baseline.|ANCOVA|||||-0.04|-0.09|<.0001
72428383|NCT01327547|144367744|SUPERIORITY_OR_OTHER||Difference in LS Mean|-44.93||||0.0947|TWO_SIDED|95.0|-97.72|7.87|||ANCOVA|||The above analysis is for CD38 expression on CD4 and CD8 cells for Week 96. Results are from an ANCOVA model with change from baseline as the response variable and the following fixed effect model terms: treatment (Maraviroc or placebo), baseline value of the response variable, HBV, PI-based regimen.||7.87|-97.72|0.0947
72339415|NCT03809910|144202404|SUPERIORITY||Adjusted Mean Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|-0.17|-0.07||Analysis was performed using ANCOVA model with product, sequence as fixed effects, participant as a random effect and two baseline terms as covariates;1-participant-level baseline score,2-period level baseline minus the participant-level baseline.|ANCOVA|||||-0.07|-0.17|<0.0001
72339416|NCT03809910|144202405|SUPERIORITY||Adjusted Mean Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|-0.16|-0.06||Analysis was performed using ANCOVA model with product, sequence as fixed effects, participant as a random effect and two baseline terms as covariates;1-participant-level baseline score,2-period level baseline minus the participant-level baseline.|ANCOVA|||||-0.06|-0.16|<0.0001
72339417|NCT03809910|144202406|SUPERIORITY||Adjusted Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.014|<|0.0001|TWO_SIDED|95.0|-0.25|-0.19||Analysis was performed using ANCOVA model with product, sequence as fixed effects, participant as a random effect and two baseline terms as covariates;1-participant-level baseline score,2-period level baseline minus the participant-level baseline.|ANCOVA|||||-0.19|-0.25|<0.0001
72339418|NCT03809910|144202407|SUPERIORITY||Adjusted Mean Difference|-0.38|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|-0.43|-0.33||Analysis was performed using ANCOVA model with product, sequence as fixed effects, participant as a random effect and two baseline terms as covariates;1-participant-level baseline score,2-period level baseline minus the participant-level baseline.|ANCOVA|||||-0.33|-0.43|<0.0001
72339419|NCT03809910|144202408|SUPERIORITY||Adjusted Mean Difference|-0.34|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|-0.39|-0.29||Analysis was performed using ANCOVA model with product, sequence as fixed effects, participant as a random effect and two baseline terms as covariates;1-participant-level baseline score,2-period level baseline minus the participant-level baseline.|ANCOVA|||||-0.29|-0.39|<0.0001
72339420|NCT03809910|144202409|SUPERIORITY||Adjusted Mean Difference|0.15|STANDARD_ERROR_OF_MEAN|0.014|<|0.0001|TWO_SIDED|95.0|0.13|0.18||Analysis was performed using ANCOVA model with product, sequence as fixed effects, participant as a random effect and two baseline terms as covariates;1-participant-level baseline score,2-period level baseline minus the participant-level baseline.|ANCOVA|||||0.18|0.13|<0.0001
72339421|NCT03809910|144202410|SUPERIORITY||Adjusted Mean Difference|0.26|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.21|0.31||Analysis was performed using ANCOVA model with product, sequence as fixed effects, participant as a random effect and two baseline terms as covariates;1-participant-level baseline score,2-period level baseline minus the participant-level baseline.|ANCOVA|||||0.31|0.21|<0.0001
72339422|NCT03809910|144202411|SUPERIORITY||Adjusted Mean Difference|0.23|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.18|0.28||Analysis was performed using ANCOVA model with product, sequence as fixed effects, participant as a random effect and two baseline terms as covariates;1-participant-level baseline score,2-period level baseline minus the participant-level baseline.|ANCOVA|||||0.28|0.18|<0.0001
72339423|NCT03809910|144202412|SUPERIORITY||Adjusted Mean Difference|0.12|STANDARD_ERROR_OF_MEAN|0.014|<|0.0001|TWO_SIDED|95.0|0.09|0.15||Analysis was performed using ANCOVA model with product, sequence as fixed effects, participant as a random effect and two baseline terms as covariates;1-participant-level baseline score,2-period level baseline minus the participant-level baseline.|ANCOVA|||||0.15|0.09|<0.0001
72339424|NCT03809910|144202412|SUPERIORITY||Adjusted Mean Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.014||0.0214|TWO_SIDED|95.0|-0.06|0.0||Analysis was performed using ANCOVA model with product, sequence as fixed effects, participant as a random effect and two baseline terms as covariates;1-participant-level baseline score,2-period level baseline minus the participant-level baseline.|ANCOVA|||||-0.00|-0.06|0.0214
72339425|NCT03809910|144202413|SUPERIORITY||Adjusted Mean Difference|0.18|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.13|0.23||Analysis was performed using ANCOVA model with product, sequence as fixed effects, participant as a random effect and two baseline terms as covariates;1-participant-level baseline score,2-period level baseline minus the participant-level baseline.|ANCOVA|||||0.23|0.13|<0.0001
72339426|NCT03809910|144202413|SUPERIORITY||Adjusted Mean Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.025||0.001|TWO_SIDED|95.0|-0.14|-0.04||Analysis was performed using ANCOVA model with product, sequence as fixed effects, participant as a random effect and two baseline terms as covariates;1-participant-level baseline score,2-period level baseline minus the participant-level baseline.|ANCOVA|||||-0.04|-0.14|0.0010
72339427|NCT03809910|144202414|SUPERIORITY||Adjusted Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.15|0.25||Analysis was performed using ANCOVA model with product, sequence as fixed effects, participant as a random effect and two baseline terms as covariates;1-participant-level baseline score,2-period level baseline minus the participant-level baseline.|ANCOVA|||||0.25|0.15|<0.0001
72339428|NCT03809910|144202414|SUPERIORITY||Adjusted Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.026||0.1652|TWO_SIDED|95.0|-0.09|0.01||Analysis was performed using ANCOVA model with product, sequence as fixed effects, participant as a random effect and two baseline terms as covariates;1-participant-level baseline score,2-period level baseline minus the participant-level baseline.|ANCOVA|||||0.01|-0.09|0.1652
72339429|NCT03131596|144202422|SUPERIORITY|||||||0.012||||||The p-value is not adjusted and a p-value of \< 0.05 is considered statistically significant.|Chi-squared|||200 patients were eligible and randomised in a 1:1 fashion. 9 patients did not complete the full protocol, resulting in 94 cases in the balloon group and 97 cases in the control group included in the final analysis. Intention-to-treat analysis was conducted.The null hypothesis is the percentage of the patients with reformed uterine adhesion in balloon group will less than the percentage of the patients with reformed uterine adhesion in control group. A Chi-squared analysis was used.||||0.012
72339430|NCT03131596|144202423|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
72339431|NCT03131596|144202424|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
72339432|NCT03131596|144202425|SUPERIORITY||||||>|0.05|||||||Chi-squared|||||||>0.05
72339433|NCT03323736|144202451|SUPERIORITY|The Procedural Success endpoint would be successfully met if the lower bound of the 95% Credible Interval (lower limit 0.80) exceeded the 68% success rate performance goal.|Credible Interval|0.86|||||TWO_SIDED|95.0|0.8|0.91||||||Procedural success rate was compared to the performance goal of 68% using a Bayesian Hierarchical model.||0.91|0.80|
72339434|NCT03323736|144202451|SUPERIORITY|The Procedural Success endpoint would be successfully met if the lower bound of the 95% Credible Interval (lower limit 0.82) exceeded the 68% success rate performance goal.|Credible Interval|0.89|||||TWO_SIDED|95.0|0.82|0.93||||||Procedural success rate was compared to the performance goal of 68% using a Bayesian Hierarchical model.||0.93|0.82|
72339435|NCT03323736|144202452|SUPERIORITY|Comparison of mean tube placement FPS-R score to a performance goal of 4.2.||||||0.0072||||||Mean FPS-R score hypothesized to be less than (superior to) a performance goal of 4.2, at a significance level of 0.025 (p\<0.025).|t-test, 1 sided|||||||0.0072
72339436|NCT03323736|144202453|SUPERIORITY||||||<|0.0001||||||Pre-specified threshold for superiority was \>80%, at alpha = 0.025.|mid-P method for single proportion|||Tube Patency endpoint would be successfully met if the percentage of subjects with patent tubes was greater than (superior to) 80% (by subject), at a significance level of 0.025 (p\<0.025).||||<0.0001
72339437|NCT03323736|144202454|SUPERIORITY||||||<|0.0001||||||Pre-specified threshold for superiority was \>88%, at alpha = 0.025.|mid-P method for single proportion|||Tube Retention endpoint would be successfully met if the percentage of subjects with retained tubes was greater than (superior to) 88% (by subject), at a significance level of 0.025 (p\<0.025).||||<0.0001
72339438|NCT03323736|144202455|SUPERIORITY||||||<|0.0001||||||Pre-specified threshold for superiority was \>85%, at alpha = 0.025.|mid-P method for single proportion|||The Anesthesia Effectiveness endpoint would be successfully met if the percentage of subjects with successful anesthesia was greater than (superior to) 85% (by subject), at a significance level of 0.025 (p\<0.025).||||<0.0001
72428384|NCT01327547|144367744|SUPERIORITY_OR_OTHER||Difference in LS Mean|-29.75||||0.3595|TWO_SIDED|95.0|-93.74|34.24|||ANCOVA|||The above analysis is for CD38 expression on CD4 and CD8 cells for Week 144. Results are from an ANCOVA model with change from baseline as the response variable and the following fixed effect model terms: treatment (Maraviroc or placebo), baseline value of the response variable, HBV, PI-based regimen.||34.24|-93.74|0.3595
72339439|NCT01688739|144202480|OTHER||Ratio of Geometric Means|1.1||||0.7595|TWO_SIDED|90.0|0.8|1.4|||ANCOVA||Migraine participants / Healthy Participants|||1.4|0.8|0.7595
72339440|NCT01688739|144202482|OTHER||Ratio of Geometric Means|1.1||||0.5481|TWO_SIDED|90.0|0.9|1.4|||ANCOVA||Migraine participants / Healthy participants|||1.4|0.9|0.5481
72339441|NCT01688739|144202483|OTHER||Ratio of Geometric Means|1.1||||0.5506|TWO_SIDED|90.0|0.9|1.4|||ANCOVA||Migraine participants / Healthy participants|||1.4|0.9|0.5506
72339442|NCT00046930|144202498|SUPERIORITY_OR_OTHER_LEGACY|||||||0.28||95.0|||||Log Rank|Stratified on age (\< 70 vs. \>=70) and type of leukemia (de novo AML, secondary RAEB-t, or secondary RAEB AML)||The study was designed to have 80% power to detect a non-proportional hazards difference in OS at the one-sided 0.025 significance level of 30.2% vs 39.6%, 12.8% vs 27.1% and 7.0% vs 14.0% at 1 years, 2 years, and full information for zosuquidar and placebo, respectively.||||0.28
72339443|NCT00046930|144202499|SUPERIORITY_OR_OTHER_LEGACY|||||||0.16||95.0|||||Log Rank|Stratified on age and type of leukemia||||||0.16
72339444|NCT00046930|144202500|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.12||||0.617|TWO_SIDED|95.0|0.77|1.65||Test was stratified on age and type of leukemia.|Mantel Haenszel||Zosuquidar/Placebo|Test of difference in the CR (complete remission) rate between the arms.||1.65|0.77|0.617
72339445|NCT02317809|144202507|NON_INFERIORITY_OR_EQUIVALENCE|Bio-equivalence Analysis was performed with Equivalence Acceptance Range for 90% Confidence Interval (CI) as 80.00% - 125.00%|Geometric least squares (LS) mean ratio|114.45|||||TWO_SIDED|90.0|110.87|118.15|||||Percentage of geometric LS mean ratio was presented.|Mixed model analysis was used.||118.15|110.87|
72339446|NCT02317809|144202508|NON_INFERIORITY_OR_EQUIVALENCE|Bio-equivalence Analysis was performed with Equivalence Acceptance Range for 90% Confidence Interval (CI) as 80.00% - 125.00%.|Geometric least squares (LS) mean ratio|106.99|||||TWO_SIDED|90.0|101.42|112.86|||||Percentage of geometric LS mean ratio was presented.|Mixed model analysis was used.||112.86|101.42|
72339447|NCT02317809|144202509|NON_INFERIORITY_OR_EQUIVALENCE|Bio-equivalence Analysis was performed with Equivalence Acceptance Range for 90% Confidence Interval (CI) as 80.00% - 125.00%.|Geometric least squares (LS) mean ratio|112.67|||||TWO_SIDED|90.0|106.44|119.27|||||Percentage of geometric LS mean ratio was presented.|Mixed model analysis was used.||119.27|106.44|
72428385|NCT01327547|144367745|SUPERIORITY_OR_OTHER||Difference in LS Mean|-2.53||||0.4476|TWO_SIDED|95.0|-9.11|4.05|||ANCOVA||Difference in LS Mean|The above analysis is for C-reactive protein cells at Week 48. Results are from an ANCOVA model with change from baseline as the response variable and the following fixed effect model terms: treatment (Maraviroc or placebo), baseline value of the response variable, HBV, PI-based regimen.||4.05|-9.11|0.4476
72339448|NCT02317809|144202510|NON_INFERIORITY_OR_EQUIVALENCE|Bio-equivalence Analysis was performed with Equivalence Acceptance Range for 90% Confidence Interval (CI) as 80.00% - 125.00%|Geometric least squares (LS) mean ratio|103.27|||||TWO_SIDED|90.0|93.16|114.47|||||Percentage of geometric LS mean ratio was presented.|Mixed model analysis was used.||114.47|93.16|
72339449|NCT06504524|144202531|OTHER||Hazard Ratio (HR)|1.128|||=|0.615|TWO_SIDED|95.0|0.705|1.804|||Regression, Cox||IPTW hazard ratio (HR) were estimated using weighted Cox proportional hazard models and confidence intervals were estimated using robust error variances. Stabilized IPT weights truncated at the 99.5th percentile were used.|||1.804|0.705|=0.615
72339450|NCT06504524|144202532|OTHER||Hazard Ratio (HR)|1.18|||=|0.4429|TWO_SIDED|95.0|0.85|1.64|||Regression, Cox||IPTW HR were estimated using weighted Cox proportional hazard models and confidence intervals were estimated using robust error variances. Stabilized IPT weights truncated at the 99.5th percentile were used.|||1.64|0.85|=0.4429
72339451|NCT06504524|144202533|OTHER||Hazard Ratio (HR)|0.66|||=|0.12|TWO_SIDED|95.0|0.39|1.115|||Regression, Cox||IPTW HR were estimated using weighted Cox proportional hazard models and confidence intervals were estimated using robust error variances. Stabilized IPT weights truncated at the 99.5th percentile were used.|||1.115|0.390|=0.120
72339452|NCT06504524|144202534|OTHER||Hazard Ratio (HR)|0.52|||=|0.0011|TWO_SIDED|95.0|0.38|0.71|||Regression, Cox||IPTW HR were estimated using weighted Cox proportional hazard models and confidence intervals were estimated using robust error variances. Stabilized IPT weights truncated at the 99.5th percentile were used.|||0.71|0.38|=0.0011
72339453|NCT06504524|144202535|OTHER||Hazard Ratio (HR)|0.759|||=|0.503|TWO_SIDED|95.0|0.337|1.71|||Regression, Cox||IPTW HR were estimated using weighted Cox proportional hazard models and confidence intervals were estimated using robust error variances. Stabilized IPT weights truncated at the 99.5th percentile were used.|||1.710|0.337|=0.503
72339454|NCT06504524|144202536|OTHER||Hazard Ratio (HR)|0.38|||<|0.0001|TWO_SIDED|95.0|0.26|0.57|||Regression, Cox||IPTW HR were estimated using weighted Cox proportional hazard models and confidence intervals were estimated using robust error variances. Stabilized IPT weights truncated at the 99.5th percentile were used.|||0.57|0.26|<0.0001
72339455|NCT06504524|144202537|OTHER||Hazard Ratio (HR)|0.918|||=|0.706|TWO_SIDED|95.0|0.587|1.436|||Regression, Cox||IPTW HR were estimated using weighted Cox proportional hazard models and confidence intervals were estimated using robust error variances. Stabilized IPT weights truncated at the 99.5th percentile were used.|||1.436|0.587|=0.706
72339456|NCT06504524|144202538|OTHER||Hazard Ratio (HR)|0.68|||=|0.0182|TWO_SIDED|95.0|0.52|0.88|||Regression, Cox||IPTW HR were estimated using weighted Cox proportional hazard models and confidence intervals were estimated using robust error variances. Stabilized IPT weights truncated at the 99.5th percentile were used.|||0.88|0.52|=0.0182
72339457|NCT00733135|144202560|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0|||||GEE|||||||<0.05
72339458|NCT00824005|144202566|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.0|STANDARD_ERROR_OF_MEAN|2.9||0.169|TWO_SIDED|95.0|-0.42|2.34||No adjustment for multiple comparisons|t-test, 2 sided|||Compare the change in the cell group to the change in the placebo group.||2.34|-0.42|0.169
72339459|NCT00824005|144202567|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.0|STANDARD_ERROR_OF_MEAN|23.9||0.856|TWO_SIDED|95.0|-10.05|12.07|||t-test, 2 sided|||Change in the difference of end systolic volume over time.||12.07|-10.05|0.856
72428386|NCT01327547|144367745|SUPERIORITY_OR_OTHER||Difference in LS Mean|0.67||||0.3012|TWO_SIDED|95.0|-0.61|1.96|||ANCOVA|||The above analysis is for C-reactive protein cells at Week 96. Results are from an ANCOVA model with change from baseline as the response variable and the following fixed effect model terms: treatment (Maraviroc or placebo), baseline value of the response variable, HBV, PI-based regimen.||1.96|-0.61|0.3012
72339460|NCT00824005|144202568|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.2|STANDARD_ERROR_OF_MEAN|22.3||0.835|TWO_SIDED|95.0|-12.5|10.1||Is the change in percent reversible defect the same between the two groups|t-test, 2 sided|||Change in percent of the defect that is reversible||10.1|-12.5|0.835
72339461|NCT00824005|144202571|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1|STANDARD_ERROR_OF_MEAN|0.5||0.471|TWO_SIDED|95.0|-0.3|0.14|||t-test, 2 sided|||Difference in the change between the two groups||0.14|-0.30|0.471
72339462|NCT00824005|144202572|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.25|STANDARD_DEVIATION|0.784||0.227|TWO_SIDED|95.0|-0.66|0.16|||t-test, 2 sided|||Change in average improvement in Canadian Class Score over time between the two groups.||0.16|-0.66|0.227
72339463|NCT00824005|144202573|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.176|STANDARD_ERROR_OF_MEAN|0.845||0.361|TWO_SIDED|95.0|-0.56|0.21|||t-test, 2 sided|||Difference in the change in NYHA score between the two groups||0.21|-0.56|0.361
72339464|NCT00824005|144202574|SUPERIORITY_OR_OTHER||Difference in the proportion of particip|0.04|STANDARD_DEVIATION|0.045||0.28|TWO_SIDED|95.0|-0.01|0.09|||Chi-squared|||Difference in the change in anti-anginal meds across groups||0.09|-0.01|0.28
72339465|NCT00824005|144202575|SUPERIORITY_OR_OTHER||Mean Difference (Net)|104.0|STANDARD_DEVIATION|409.0||0.302|TWO_SIDED|95.0|-95.0|303.0|||t-test, 2 sided|||Change in six minute walk distance||303|-95|0.302
72339466|NCT00824005|144202576|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-34.7|STANDARD_DEVIATION|176.0||0.55|TWO_SIDED|95.0|-150.0|80.0|||t-test, 2 sided|||Difference in the change in BNP(reg) between cell and placebo group||80|-150|0.55
72339467|NCT00824005|144202577|SUPERIORITY_OR_OTHER||Mean Difference (Net)|9.5|STANDARD_DEVIATION|31.2||0.198|TWO_SIDED|95.0|-5.03|23.93|||t-test, 2 sided|||Change in the difference of end diastolic volume between the two groups over time.||23.93|-5.03|0.198
72339468|NCT00824005|144202578|SUPERIORITY_OR_OTHER||Difference in the incidence rates|-0.047|STANDARD_ERROR_OF_MEAN|0.044||0.47|TWO_SIDED|95.0|-0.133|0.039|||t-test, 2 sided|||The difference in the incidence of major adverse cardiac events between the two groups over time. (Incidence rate)||0.039|-0.133|0.47
72339469|NCT00824005|144202579|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.7|STANDARD_ERROR_OF_MEAN|8.4||0.7|TWO_SIDED|95.0|-4.78|3.36|||t-test, 2 sided|||Difference in the change between the two groups||3.36|-4.78|0.7
72339470|NCT03458702|144202580|EQUIVALENCE|It would be expected at baseline that there were no differences between groups.|||||>|0.05|||||||t-test, 2 sided|||||||>.05
72339471|NCT03458702|144202580|SUPERIORITY||||||<|0.001|||||||ANOVA|||ANOVA for TIME||||<0.001
72339472|NCT03458702|144202581|EQUIVALENCE|It would be expected at baseline there would be no difference between groups.|||||>|0.05|||||||ANOVA|||||||>.05
72339473|NCT03458702|144202581|SUPERIORITY||||||<|0.001|||||||ANOVA|||ANOVA: Condition x Time Interaction||||<0.001
72339474|NCT03458702|144202581|SUPERIORITY|||||||0.005|||||||ANOVA|||ANOVA: TIME||||0.005
72339475|NCT03458702|144202582|EQUIVALENCE|It would be hypothesized that there would not be a difference at baseline.|||||>|0.05|||||||ANOVA|||||||> .05
72339476|NCT03458702|144202582|SUPERIORITY|||||||0.042|||||||ANOVA|||ANOVA: CONDITION X TIME INTERACTION||||0.042
72339477|NCT03458702|144202582|SUPERIORITY||||||<|0.001|||||||Chi-squared, Corrected|||ANOVA: TIME||||<0.001
72339478|NCT03458702|144202583|EQUIVALENCE|A difference at baseline was not expected.|||||>|0.05|||||||ANOVA|||||||>.05
72339479|NCT03458702|144202583|SUPERIORITY|||||||0.016|||||||ANOVA|||ANOVA: TIME||||0.016
72339480|NCT03458702|144202584|EQUIVALENCE|no difference is expected at baseline|||||>|0.05|||||||ANOVA|||||||>.05
72339481|NCT03458702|144202584|SUPERIORITY|||||||0.026|||||||ANOVA|||ANOVA:TIME||||0.026
72339482|NCT03458702|144202585|SUPERIORITY||||||<|0.05|||||||t-test, 1 sided|||||||<.05
72339483|NCT01874275|144202590|SUPERIORITY_OR_OTHER|||||||0.2413|TWO_SIDED||||||Mixed Models Analysis|||||||0.2413
72339484|NCT00168103|144202594|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.525||||0.0025|TWO_SIDED|95.0|-2.217|-0.033||1-sided P-value. The a priori threshold was 0.024 (overall Type 1 error 0.025 adjusted for alpha spending for an interim analysis).|Wilcoxon (Mann-Whitney)|1-sided|The median difference was estimated by the Hodges-Lehmann estimate.|||-0.033|-2.217|0.0025
72339485|NCT00168103|144202595|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.1088||||0.0014|TWO_SIDED|80.0|0.0392|0.3023||1-sided P-value. The a priori threshold for significance was 0.1 (trend).|Fisher Exact|1-sided|The Odds Ratio was calculated as C1-INH 20 U/kg bw (numerator) versus Placebo (denominator).|Worsened intensity was evaluated between 2 and 4 hours after start of study treatment relative to baseline for at least 1 of the HAE symptoms present at baseline.||0.3023|0.0392|0.0014
72339486|NCT00168103|144202596|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-3.292||||0.0237|TWO_SIDED|80.0|-5.15|-1.05||1-sided, exploratory test.|Wilcoxon (Mann-Whitney)|1-sided|The median difference was estimated by the Hodge-Lehmann estimate.|This was an exploratory analysis.||-1.050|-5.150|0.0237
72339487|NCT00168103|144202597|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.1714|||||TWO_SIDED|95.0|0.0642|0.4575|||||The Odds Ratio was calculated as C1-INH 20 U/kg bw (numerator) versus Placebo (denominator).|This was an exploratory analysis.||0.4575|0.0642|
72339488|NCT00168103|144202598|SUPERIORITY_OR_OTHER|||||||0.0329|TWO_SIDED|80.0||||1-sided P-value. The a priori threshold for significance was 0.1 (trend).|Wilcoxon (Mann-Whitney)|1-sided||||||0.0329
72339489|NCT00989235|144202601|SUPERIORITY_OR_OTHER||Adjusted difference|0.18|||||TWO_SIDED|95.0|-0.11|0.46|||ANCOVA|Adjustment based on ANCOVA model with treatment as factor and baseline value as covariate.|Change from Baseline = Post-baseline - Baseline value.|Day 29||0.46|-0.11|
72339490|NCT00989235|144202601|SUPERIORITY_OR_OTHER||Adjusted Difference|-0.09|||||TWO_SIDED|95.0|-0.34|0.17|||ANCOVA|Adjustment based on ANCOVA model with treatment as factor and baseline value as covariate.|Change from Baseline = Post-baseline - Baseline value.|Day 57||0.17|-0.34|
72339491|NCT00989235|144202601|SUPERIORITY_OR_OTHER||Adjusted Difference|-0.08|||||TWO_SIDED|95.0|-0.37|0.2|||ANCOVA|Adjustment based on ANCOVA model with treatment as factor and baseline value as covariate.|Change from Baseline = Post-baseline - Baseline value.|Day 85||0.20|-0.37|
72339492|NCT00989235|144202601|SUPERIORITY_OR_OTHER||Adjusted Difference|-0.23|||||TWO_SIDED|95.0|-0.5|0.04|||ANCOVA|Adjustment based on ANCOVA model with treatment as factor and baseline value as covariate.|Change from Baseline = Post-baseline - Baseline value.|Day 113||0.04|-0.50|
72339493|NCT00989235|144202601|SUPERIORITY_OR_OTHER||Adjusted Difference|0.03|||||TWO_SIDED|95.0|-0.26|0.32|||ANCOVA|Adjustment based on ANCOVA model with treatment as factor and baseline value as covariate.|Change from Baseline = Post-baseline - Baseline value.|Day 141||0.32|-0.26|
72339494|NCT00989235|144202601|SUPERIORITY_OR_OTHER||Adjusted Difference|-0.13|||||TWO_SIDED|95.0|-0.41|0.15|||ANCOVA|Adjustment based on ANCOVA model with treatment as factor and baseline value as covariate.|Change from Baseline = Post-baseline - Baseline value.|Day 169||0.15|-0.41|
72339495|NCT00989235|144202601|SUPERIORITY_OR_OTHER||Adjusted Difference|-0.12|||||TWO_SIDED|95.0|-0.38|0.13|||ANCOVA|Adjustment based on ANCOVA model with treatment as factor and baseline value as covariate.|Change from Baseline = Post-baseline - Baseline value.|Day 197||0.13|-0.38|
72339496|NCT00989235|144202601|SUPERIORITY_OR_OTHER||Adjusted Difference|-0.04|||||TWO_SIDED|95.0|-0.32|0.25|||ANCOVA|Adjustment based on ANCOVA model with treatment as factor and baseline value as covariate.|Change from Baseline = Post-baseline - Baseline value.|Day 225||0.25|-0.32|
72339497|NCT00989235|144202601|SUPERIORITY_OR_OTHER||Adjusted Difference|0.08|||||TWO_SIDED|95.0|-0.19|0.36|||ANCOVA|Adjustment based on ANCOVA model with treatment as factor and baseline value as covariate.|Change from Baseline = Post-baseline - Baseline value.|Day 253||0.36|-0.19|
72339498|NCT00989235|144202601|SUPERIORITY_OR_OTHER||Adjusted Difference|0.13|||||TWO_SIDED|95.0|-0.12|0.38|||ANCOVA|Adjustment based on ANCOVA model with treatment as factor and baseline value as covariate.|Change from Baseline = Post-baseline - Baseline value.|Day 281||0.38|-0.12|
72339499|NCT00989235|144202601|SUPERIORITY_OR_OTHER||Adjusted Difference|-0.03|||||TWO_SIDED|95.0|-0.27|0.22|||ANCOVA|Adjustment based on ANCOVA model with treatment as factor and baseline value as covariate.|Change from Baseline = Post-baseline - Baseline value.|Day 309||0.22|-0.27|
72339500|NCT00989235|144202601|SUPERIORITY_OR_OTHER||Adjusted Difference|-0.03|||||TWO_SIDED|95.0|-0.37|0.31|||ANCOVA|Adjustment based on ANCOVA model with treatment as factor and baseline value as covariate.|Change from Baseline = Post-baseline - Baseline value.|Day 337||0.31|-0.37|
72339501|NCT00989235|144202601|SUPERIORITY_OR_OTHER||Adjusted Difference|0.23|||||TWO_SIDED|95.0|-0.09|0.55|||ANCOVA|Adjustment based on ANCOVA model with treatment as factor and baseline value as covariate.|Change from Baseline = Post-baseline - Baseline value.|Day 365||0.55|-0.09|
72339502|NCT00989235|144202602|SUPERIORITY_OR_OTHER||estimate of difference|0.4|||||TWO_SIDED|95.0|-17.2|18.0|||normal approximation|For 95% CI: normal approximation with continuity correction.||||18.0|-17.2|
72339503|NCT00989235|144202603|SUPERIORITY_OR_OTHER||estimate of difference|-8.6|||||TWO_SIDED|95.0|-20.3|3.2|||normal approximation|For 95% CI: normal approximation with continuity correction.||||3.2|-20.3|
72339504|NCT00989235|144202605|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.87|||||TWO_SIDED|95.0|0.45|1.69|||Cox proportional hazards model||Hazard ratio determined by a Cox proportional hazards model with treatment as the only covariate.|Through Month 12||1.69|0.45|
72339505|NCT00989235|144202606|SUPERIORITY_OR_OTHER||estimate of difference|-1.1|||||TWO_SIDED|95.0|-12.9|10.7|||normal approximation|For 95% CI: normal approximation with continuity correction.||||10.7|-12.9|
72339506|NCT00989235|144202607|SUPERIORITY_OR_OTHER||estimate of difference|-7.7|||||TWO_SIDED|95.0|-22.6|7.3|||normal approximation|95% CI: normal approximation with continuity correction.||||7.3|-22.6|
72339507|NCT00989235|144202608|SUPERIORITY_OR_OTHER||estimate of difference|-10.6|||||TWO_SIDED|95.0|-31.1|10.0|||normal approximation|95% CI: normal approximation with continuity correction.||||10.0|-31.1|
72339508|NCT01394614|144202664|SUPERIORITY_OR_OTHER||Incidence-rate difference|0.41|||||TWO_SIDED||||||||Difference between the incidence rate of exposed-to-vaccine cases (0.52) and that of unexposed cases (0.11) is 0.41 per 100,000 persons-years|||||
72339509|NCT01394614|144202664|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|4.32|||||TWO_SIDED|95.0|1.5|11.12|||||Risk of developing narcolepsy if exposed to H1N1 vaccination (using the 16-week post-vaccination period as reference).|||11.12|1.5|
72339510|NCT02266875|144202669|SUPERIORITY|||||||0.32|||||||t-test, 2 sided|||||||0.320
72339511|NCT02266875|144202670|SUPERIORITY||||||>|0.999|||||||Fisher Exact|||||||>0.999
72339512|NCT02312765|144202717|SUPERIORITY|||||||0.72|||||||Chi-squared|||||||0.72
72339513|NCT02481713|144202741|NON_INFERIORITY|All analyses were two-tailed with alpha set at 0.05||||||0.24|||||||Wilcoxon (Mann-Whitney)|||||||0.24
72339514|NCT02481713|144202742|SUPERIORITY||Risk Ratio (RR)|1.46||||0.0001|TWO_SIDED|95.0|1.25|1.69|||Regression, zero-inflated Poisson|||||1.69|1.25|.0001
72339515|NCT04375397|144202743|SUPERIORITY||Adjusted risk difference (%)|5.8|||=|0.599|TWO_SIDED|80.0|-9.2|20.4|||Miettinen-Nurminen method||Ibrutinib 420 mg + SOC - Placebo + SOC Miettinen-Nurminen (MN) CI for the adjusted risk difference across strata|The difference in response rates between the experimental arm and the control arm were analyzed using the Miettinen-Nurminen (MN) method, adjusting for the stratification factor of prescription for remdesivir. The MN test p-value for testing the rate difference = 0 at two-sided alpha = 0.2.||20.4|-9.2|=0.599
72339516|NCT04375397|144202743|SUPERIORITY||Adjusted risk difference (%)|5.8|||=|0.599|TWO_SIDED|95.0|-18.1|28.7|||Miettinen-Nurminen method||Ibrutinib 420 mg + SOC - Placebo + SOC Miettinen-Nurminen (MN) CI for the adjusted risk difference across strata|The difference in response rates between the experimental arm and the control arm were analyzed using the Miettinen-Nurminen (MN) method, adjusting for the stratification factor of prescription for remdesivir. The MN test p-value for testing the rate difference = 0 at twosided alpha = 0.2.||28.7|-18.1|=0.599
72339517|NCT04375397|144202744|SUPERIORITY||Odds Ratio (OR)|1.17|||=|0.886|TWO_SIDED|95.0|0.13|10.44|||Multinomial Logistic Regression|||"Change in ordinal score from baseline to day 14 = -3~To evaluate the odds of clinical status improvement as determined by the WHO-8 ordinal scale, a multinomial logistic regression model was used.~Pairwise Comparison in Reference to the Group with Change = -4"||10.44|0.13|=0.886
72339518|NCT04375397|144202744|SUPERIORITY||Odds Ratio (OR)|0.64|||=|0.705|TWO_SIDED|95.0|0.06|6.43|||Multinomial Logistic Regression|||"Change in ordinal score from baseline to day 14 = -2~To evaluate the odds of clinical status improvement as determined by the WHO-8 ordinal scale, a multinomial logistic regression model was used.~Pairwise Comparison in Reference to the Group with Change = -4"||6.43|0.06|=0.705
72339519|NCT04375397|144202744|SUPERIORITY||Odds Ratio (OR)|0.0|||=|0.996|TWO_SIDED|95.0|0.0||The upper limit of this 95% CI is infinite.||Multinomial Logistic Regression|||"Change in ordinal score from baseline to day 14 = -1~To evaluate the odds of clinical status improvement as determined by the WHO-8 ordinal scale, a multinomial logistic regression model was used.~Pairwise Comparison in Reference to the Group with Change = -4"|||0.00|=0.996
72339520|NCT04375397|144202744|SUPERIORITY||Odds Ratio (OR)|1.07|||=|0.969|TWO_SIDED|95.0|0.04|32.18|||Multinomial Logistic Regression|||"Change in ordinal score from baseline to day 14 = 0~To evaluate the odds of clinical status improvement as determined by the WHO-8 ordinal scale, a multinomial logistic regression model was used.~Pairwise Comparison in Reference to the Group with Change = -4"||32.18|0.04|=0.969
72339521|NCT04375397|144202744|SUPERIORITY||Odds Ratio (OR)|1.07|||=|0.969|TWO_SIDED|95.0|0.04|32.18|||Multinomial Logistic Regression|||"Change in ordinal score from baseline to day 14 = 1~To evaluate the odds of clinical status improvement as determined by the WHO-8 ordinal scale, a multinomial logistic regression model was used.~Pairwise Comparison in Reference to the Group with Change = -4"||32.18|0.04|=0.969
72339522|NCT04375397|144202744|SUPERIORITY||Odds Ratio (OR)|1.07|||=|0.969|TWO_SIDED|95.0|0.04|32.18|||Multinomial Logistic Regression|||"Change in ordinal score from baseline to day 14 = 3~To evaluate the odds of clinical status improvement as determined by the WHO-8 ordinal scale, a multinomial logistic regression model was used.~Pairwise Comparison in Reference to the Group with Change = -4"||32.18|0.04|=0.969
72339523|NCT04375397|144202745|SUPERIORITY||Difference in Medians|-1.5|||=|0.801|TWO_SIDED||||||Van Elteren's test||Ibrutinib 420 mg + SOC - Placebo + SOC|Median days spent on supplemental oxygen was compared between treatment groups using Van Elteren's test with the stratification factor of prescription for remdesivir.||||=0.801
72339524|NCT04375397|144202746|SUPERIORITY||Mortality rate difference|0.0|||=|1|TWO_SIDED|80.0|-6.7|7.3|||Miettinen-Nurminen|||"At Day 7-- Ibrutinib 420 mg + SOC - Placebo + SOC~The Miettinen-Nurminen (MN) test p-value for testing the rate difference = 0 adjusting for the stratification factor of prescription for remdesivir using Cochran-Mantel-Haenszel weights at two-sided alpha of 0.2 and associated confidence intervals are reported."||7.3|-6.7|=1.000
72339525|NCT04375397|144202746|SUPERIORITY||Mortality rate difference|0.0|||=|1|TWO_SIDED|95.0|-14.4|15.5|||Miettinen-Nurminen|||"At Day 7-- Ibrutinib 420 mg + SOC - Placebo + SOC~The Miettinen-Nurminen (MN) test p-value for testing the rate difference = 0 adjusting for the stratification factor of prescription for remdesivir using Cochran-Mantel-Haenszel weights at two-sided alpha of 0.2 and associated confidence intervals are reported."||15.5|-14.4|=1.000
72339526|NCT04375397|144202746|SUPERIORITY||Mortality rate difference|0.0|||=|1|TWO_SIDED|80.0|-6.7|7.3|||Miettinen-Nurminen|||"At Day 14-- Ibrutinib 420 mg + SOC - Placebo + SOC~The Miettinen-Nurminen (MN) test p-value for testing the rate difference = 0 adjusting for the stratification factor of prescription for remdesivir using Cochran-Mantel-Haenszel weights at two-sided alpha of 0.2 and associated confidence intervals are reported."||7.3|-6.7|=1.000
72339527|NCT04375397|144202746|SUPERIORITY||Mortality rate difference|0.0|||=|1|TWO_SIDED|95.0|-14.4|15.5|||Miettinen-Nurminen|||"At Day 14-- Ibrutinib 420 mg + SOC - Placebo + SOC~The Miettinen-Nurminen (MN) test p-value for testing the rate difference = 0 adjusting for the stratification factor of prescription for remdesivir using Cochran-Mantel-Haenszel weights at two-sided alpha of 0.2 and associated confidence intervals are reported."||15.5|-14.4|=1.000
72339528|NCT04375397|144202746|SUPERIORITY||Mortality rate difference|4.8|||=|0.267|TWO_SIDED|80.0|-1.7|14.8|||Miettinen-Nurminen|||"At Day 21-- Ibrutinib 420 mg + SOC - Placebo + SOC~The Miettinen-Nurminen (MN) test p-value for testing the rate difference = 0 adjusting for the stratification factor of prescription for remdesivir using Cochran-Mantel-Haenszel weights at two-sided alpha of 0.2 and associated confidence intervals are reported."||14.8|-1.7|=0.267
72339529|NCT04375397|144202746|SUPERIORITY||Mortality rate difference|4.8|||=|0.267|TWO_SIDED|95.0|-9.6|22.8|||Miettinen-Nurminen|||"At Day 21-- Ibrutinib 420 mg + SOC - Placebo + SOC~The Miettinen-Nurminen (MN) test p-value for testing the rate difference = 0 adjusting for the stratification factor of prescription for remdesivir using Cochran-Mantel-Haenszel weights at two-sided alpha of 0.2 and associated confidence intervals are reported."||22.8|-9.6|=0.267
72339530|NCT04375397|144202746|SUPERIORITY||Mortality rate difference|4.8|||=|0.267|TWO_SIDED|80.0|-1.7|14.8|||Miettinen-Nurminen|||"At Day 28-- Ibrutinib 420 mg + SOC - Placebo + SOC~The Miettinen-Nurminen (MN) test p-value for testing the rate difference = 0 adjusting for the stratification factor of prescription for remdesivir using Cochran-Mantel-Haenszel weights at two-sided alpha of 0.2 and associated confidence intervals are reported."||14.8|-1.7|=0.267
72339531|NCT04375397|144202746|SUPERIORITY||Mortality rate difference|4.8|||=|0.267|TWO_SIDED|95.0|-9.6|22.8|||Miettinen-Nurminen|||"At Day 28-- Ibrutinib 420 mg + SOC - Placebo + SOC~The Miettinen-Nurminen (MN) test p-value for testing the rate difference = 0 adjusting for the stratification factor of prescription for remdesivir using Cochran-Mantel-Haenszel weights at two-sided alpha of 0.2 and associated confidence intervals are reported."||22.8|-9.6|=0.267
72339532|NCT04375397|144202747|SUPERIORITY||Adjusted risk difference (%)|-10.7|||=|0.314|TWO_SIDED|80.0|-24.8|3.3|||Miettinen-Nurminen|||"Failure/Mortality Rate Difference Compared to Placebo + SOC at Day 7~The difference in response rates between the experimental arm and the control arm was analyzed using the Miettinen-Nurminen (MN) method adjusting for the stratification factor of prescription for remdesivir. MN test p-value for testing the rate difference = 0 adjusting for the stratification factor of prescription for remdesivir using Cochran-Mantel-Haenszel weights at two-sided alpha of 0.2."||3.3|-24.8|=0.314
72339533|NCT04375397|144202747|SUPERIORITY||Adjusted risk difference (%)|-10.7|||=|0.314|TWO_SIDED|95.0|-32.8|12.0|||Miettinen-Nurminen|||"Failure/Mortality Rate Difference Compared to Placebo + SOC at Day 7~The difference in response rates between the experimental arm and the control arm was analyzed using the Miettinen-Nurminen (MN) method adjusting for the stratification factor of prescription for remdesivir. MN test p-value for testing the rate difference = 0 adjusting for the stratification factor of prescription for remdesivir using Cochran-Mantel-Haenszel weights at two-sided alpha of 0.2."||12.0|-32.8|=0.314
72339534|NCT04375397|144202747|SUPERIORITY||Adjusted risk difference (%)|-10.7|||=|0.314|TWO_SIDED|80.0|-24.8|3.3|||Miettinen-Nurminen|||"Failure/Mortality Rate Difference Compared to Placebo + SOC at Day 14~The difference in response rates between the experimental arm and the control arm was analyzed using the Miettinen-Nurminen (MN) method adjusting for the stratification factor of prescription for remdesivir. MN test p-value for testing the rate difference = 0 adjusting for the stratification factor of prescription for remdesivir using Cochran-Mantel-Haenszel weights at two-sided alpha of 0.2."||3.3|-24.8|=0.314
72339535|NCT04375397|144202747|SUPERIORITY||Adjusted risk difference (%)|-10.7|||=|0.314|TWO_SIDED|95.0|-32.8|12.0|||Miettinen-Nurminen|||"Failure/Mortality Rate Difference Compared to Placebo + SOC at Day 14~The difference in response rates between the experimental arm and the control arm was analyzed using the Miettinen-Nurminen (MN) method adjusting for the stratification factor of prescription for remdesivir. MN test p-value for testing the rate difference = 0 adjusting for the stratification factor of prescription for remdesivir using Cochran-Mantel-Haenszel weights at two-sided alpha of 0.2."||12.0|-32.8|=0.314
72339536|NCT04375397|144202747|SUPERIORITY||Adjusted risk difference (%)|-5.8|||=|0.599|TWO_SIDED|80.0|-20.4|9.2|||Miettinen-Nurminen|||"Failure/Mortality Rate Difference Compared to Placebo + SOC at Day 21~The difference in response rates between the experimental arm and the control arm was analyzed using the Miettinen-Nurminen (MN) method adjusting for the stratification factor of prescription for remdesivir. MN test p-value for testing the rate difference = 0 adjusting for the stratification factor of prescription for remdesivir using Cochran-Mantel-Haenszel weights at two-sided alpha of 0.2."||9.2|-20.4|=0.599
72339537|NCT04375397|144202747|SUPERIORITY||Adjusted risk difference (%)|-5.8|||=|0.599|TWO_SIDED|95.0|-28.7|18.1|||Miettinen-Nurminen|||"Failure/Mortality Rate Difference Compared to Placebo + SOC at Day 21~The difference in response rates between the experimental arm and the control arm was analyzed using the Miettinen-Nurminen (MN) method adjusting for the stratification factor of prescription for remdesivir. MN test p-value for testing the rate difference = 0 adjusting for the stratification factor of prescription for remdesivir using Cochran-Mantel-Haenszel weights at two-sided alpha of 0.2."||18.1|-28.7|=0.599
72339538|NCT04375397|144202747|SUPERIORITY||Adjusted risk difference (%)|-5.8|||=|0.599|TWO_SIDED|80.0|-20.4|9.2|||Miettinen-Nurminen|||"Failure/Mortality Rate Difference Compared to Placebo + SOC at Day 28~The difference in response rates between the experimental arm and the control arm was analyzed using the Miettinen-Nurminen (MN) method adjusting for the stratification factor of prescription for remdesivir. MN test p-value for testing the rate difference = 0 adjusting for the stratification factor of prescription for remdesivir using Cochran-Mantel-Haenszel weights at two-sided alpha of 0.2."||9.2|-20.4|=0.599
72339539|NCT04375397|144202747|SUPERIORITY||Adjusted risk difference (%)|-5.8|||=|0.599|TWO_SIDED|95.0|-28.7|18.1|||Miettinen-Nurminen|||"Failure/Mortality Rate Difference Compared to Placebo + SOC at Day 28~The difference in response rates between the experimental arm and the control arm was analyzed using the Miettinen-Nurminen (MN) method adjusting for the stratification factor of prescription for remdesivir. MN test p-value for testing the rate difference = 0 adjusting for the stratification factor of prescription for remdesivir using Cochran-Mantel-Haenszel weights at two-sided alpha of 0.2."||18.1|-28.7|=0.599
72428387|NCT01327547|144367745|SUPERIORITY_OR_OTHER||Difference in LS Mean|0.92||||0.4196|TWO_SIDED|95.0|-1.33|3.17|||ANCOVA|||The above analysis is for C-reactive protein cells at Week 144. Results are from an ANCOVA model with change from baseline as the response variable and the following fixed effect model terms: treatment (Maraviroc or placebo), baseline value of the response variable, HBV, PI-based regimen.||3.17|-1.33|0.4196
72339540|NCT04375397|144202748|SUPERIORITY||||||=|0.851|||||||Log Rank|||For the analysis of mechanical ventilation-free survival, the distribution of time to event was estimated by treatment group using Kaplan-Meier methodology and compared between the experimental arm and the control arm using the log-rank test stratified by prescription for remdesivir.||||=0.851
72339541|NCT04375397|144202749|SUPERIORITY||Difference in Medians|0.0|||=|0.745|TWO_SIDED||||||Van Elteren's test||Ibrutinib 420 mg + SOC - Placebo + SOC|Median days spent on mechanical ventilation were compared between treatment groups using Van Elteren's test with the stratification factor of prescription for remdesivir.||||=0.745
72339542|NCT04375397|144202750|SUPERIORITY||Difference in Medians|-0.5|||=|0.977|TWO_SIDED||||||Van Elteren's test]||Ibrutinib 420 mg + SOC - Placebo + SOC|Median duration of hospitalization was compared between treatment groups using Van Elteren's test with the stratification factor of prescription for remdesivir.||||=0.977
72339543|NCT04375397|144202751|SUPERIORITY||||||=|0.969|||||||Log Rank|||For the analysis of time to discharge from hospital, the distribution of time to event was estimated by treatment group using Kaplan-Meier methodology and compared between the experimental arm and the control arm using the log-rank test stratified by prescription for remdesivir.||||=0.969
72339544|NCT00610441|144202780|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.6996||||0.0147|TWO_SIDED|97.5|-10.911|-0.4881||To correct for multiplicity, p-values (2-sided) should be compared with the 2.5% level of significance.|Mixed Model for Repeated Measurements||Mixed Model for Repeated Measurements (MMRM) with fixed effects for treatment, period, visit, center and treatment by visit interaction, and random effect for participant, and baseline AISRS score as covariate.|The treatment difference between 100 mg MK-8777 fixed dose and Placebo was estimated for the average effect (average change from baseline) of the 2nd and 3rd week of each period (Day 14 and Day 21).||-0.4881|-10.911|0.0147
72339545|NCT00610441|144202780|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.9926||||0.591|TWO_SIDED|97.5|-3.2961|5.2814||To correct for multiplicity, p-values (2-sided) should be compared with the 2.5% level of significance.|MMRM||MMRM with fixed effects for treatment, period, visit, center and treatment by visit interaction, and random effect for participant, and baseline AISRS score as covariate.|The treatment difference between 100-300 mg MK-8777 rising dose and Placebo was estimated for the average effect (average change from baseline) of the 2nd and 3rd week of each period (Day 14 and Day 21).||5.2814|-3.2961|0.5910
72339546|NCT00610441|144202781|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.8506|||||TWO_SIDED|95.0|1.799|26.0878|||||Logistic regression with fixed effects for treatment and period, and baseline AISRS score as covariate.|||26.0878|1.7990|
72339547|NCT00610441|144202781|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.9461|||||TWO_SIDED|95.0|0.3119|2.8701|||||Logistic regression with fixed effects for treatment and period, and baseline AISRS score as covariate.|||2.8701|0.3119|
72339548|NCT00610441|144202782|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.2468|||||TWO_SIDED|95.0|0.6712|58.1395|||||Since no participants in the Placebo group achieved a 50% reduction, the comparison was done using a Cochran-Mantel-Haenszel method and 0.5 was added to both groups.|||58.1395|0.6712|
72339549|NCT00610441|144202782|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.1453|||||TWO_SIDED|95.0|0.0152|1.388|||||Logistic regression with fixed effects for treatment and period, and baseline AISRS score as covariate.|||1.3880|0.0152|
72339550|NCT00610441|144202785|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.2074|||||TWO_SIDED|95.0|0.5654|2.5785|||||Proportional odds model with fixed effects for treatment and period.|||2.5785|0.5654|
72339551|NCT00610441|144202785|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.8548|||||TWO_SIDED|95.0|0.6951|4.9494|||||Proportional odds model with fixed effects for treatment and period.|||4.9494|0.6951|
72339552|NCT00610441|144202786|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.3149|||||TWO_SIDED|95.0|0.5402|3.2008|||||Proportional odds model with fixed effects for treatment and period.|||3.2008|0.5402|
72339553|NCT00610441|144202786|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.3982|||||TWO_SIDED|95.0|0.524|3.7309|||||Proportional odds model with fixed effects for treatment and period.|||3.7309|0.5240|
72339554|NCT00610441|144202787|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.3163||||0.6155|TWO_SIDED|97.5|-1.8138|1.1812||To correct for multiplicity, p-values (2-sided) should be compared with the 2.5% level of significance.|MMRM||MMRM with fixed effects for treatment, period, visit, center and treatment by visit interaction, and random effect for participant, and baseline ESS score as covariate. For statistical analyses, the average score from Days 14 and 21 was used.|The treatment difference between 100 mg MK-8777 fixed dose and Placebo was estimated for the average effect (average change from baseline) of the 2nd and 3rd week of each period (Day 14 and Day 21).||1.1812|-1.8138|0.6155
72339555|NCT00610441|144202787|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.2934||||0.133|TWO_SIDED|97.5|-0.7449|3.3317||To correct for multiplicity, p-values (2-sided) should be compared with the 2.5% level of significance.|MMRM||MMRM with fixed effects for treatment, period, visit, center and treatment by visit interaction, and random effect for participant, and baseline ESS score as covariate. For statistical analyses, the average score from Days 14 and 21 was used.|The treatment difference between 100-300 mg MK-8777 rising dose and Placebo was estimated for the average effect (average change from baseline) of the 2nd and 3rd week of each period (Day 14 and Day 21).||3.3317|-0.7449|0.1330
72339556|NCT00610441|144202788|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.5501||||0.3907|TWO_SIDED|97.5|-0.9427|2.0429||To correct for multiplicity, p-values (2-sided) should be compared with the 2.5% level of significance.|MMRM||MMRM with fixed effects for treatment, period, visit, center and treatment by visit interaction, and random effect for participant, and baseline PSQI score as covariate.|The treatment difference between 100 mg MK-8777 fixed dose and Placebo was estimated for the average effect (average change from baseline) of the 2nd and 3rd week of each period (Day 14 and Day 21).||2.0429|-0.9427|0.3907
72339557|NCT00610441|144202788|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.0065||||0.9872|TWO_SIDED|97.5|-0.9486|0.9357||To correct for multiplicity, p-values (2-sided) should be compared with the 2.5% level of significance.|MMRM||MMRM with fixed effects for treatment, period, visit, center and treatment by visit interaction, and random effect for participant, and baseline PSQI score as covariate.|The treatment difference between 100-300 mg MK-8777 rising dose and Placebo was estimated for the average effect (average change from baseline) of the 2nd and 3rd week of each period (Day 14 and Day 21).||0.9357|-0.9486|0.9872
72428388|NCT01327547|144367746|SUPERIORITY_OR_OTHER||Difference in LS Mean|0.3||||0.9904|TWO_SIDED|95.0|-48.66|49.26||Not specifed.|ANCOVA||Difference in LS Mean|The above analysis is for D-Dimer cells at Week 48. Results are from an ANCOVA model with change from baseline as the response variable and the following fixed effect model terms: treatment (Maraviroc or placebo), baseline value of the response variable, HBV, PI-based regimen.||49.26|-48.66|0.9904
72339558|NCT00610441|144202789|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1543||||0.7828|TWO_SIDED|97.5|-1.4898|1.1811||To correct for multiplicity, p-values (2-sided) should be compared with the 2.5% level of significance.|MMRM||MMRM with fixed effects for treatment, period, visit, center and treatment by visit interaction, and random effect for participant, and baseline QIDS-C score as covariate. Scores from Days 14 and 21 were averaged for statistical analyses.|The treatment difference between 100 mg MK-8777 fixed dose and Placebo was estimated for the average effect (average change from baseline) of the 2nd and 3rd week of each period (Day 14 and Day 21).||1.1811|-1.4898|0.7828
72339559|NCT00610441|144202789|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.4222||||0.2883|TWO_SIDED|97.5|-0.5187|1.363||To correct for multiplicity, p-values (2-sided) should be compared with the 2.5% level of significance.|MMRM||MMRM with fixed effects for treatment, period, visit, center and treatment by visit interaction, and random effect for participant, and baseline QIDS-C score as covariate. Scores from Days 14 and 21 were averaged for statistical analyses.|The treatment difference between 100-300 mg MK-8777 rising dose and Placebo was estimated for the average effect (average change from baseline) of the 2nd and 3rd week of each period (Day 14 and Day 21).||1.3630|-0.5187|0.2883
72339560|NCT00610441|144202790|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.9685||||0.6532|TWO_SIDED|97.5|-5.9599|4.0229|||MMRM|To correct for multiplicity, p-values (2-sided) should be compared with the 2.5% level of significance.|MMRM with fixed effects for treatment, period, visit, center and treatment by visit interaction, and random effect for participant, and baseline TASS score as covariate.|The treatment difference between 100 mg MK-8777 fixed dose and Placebo was estimated for the average effect (average change from baseline) of the 2nd and 3rd week of each period (Day 14 and Day 21).||4.0229|-5.9599|0.6532
72339561|NCT00610441|144202790|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.1022||||0.5247|TWO_SIDED|97.5|-2.8951|5.0996||To correct for multiplicity, p-values (2-sided) should be compared with the 2.5% level of significance.|MMRM||MMRM with fixed effects for treatment, period, visit, center and treatment by visit interaction, and random effect for participant, and baseline TASS score as covariate.|The treatment difference between 100-300 mg MK-8777 rising dose and Placebo was estimated for the average effect (average change from baseline) of the 2nd and 3rd week of each period (Day 14 and Day 21).||5.0996|-2.8951|0.5247
72339562|NCT00554099|144202802|SUPERIORITY_OR_OTHER||Mean Difference vs. Placebo|-3.0|STANDARD_ERROR_OF_MEAN|1.69||0.3781|ONE_SIDED|90.0||-0.809|||ANCOVA|Fixed effects for treatment, number of diverticulitis attacks and baseline value as covariate.||It was assumed that the placebo treatment group and mesalamine treatment group would have an average composite score of 8.4 and 5.88 at Week 12, respectively. The common standard deviation was set to 4.5 based on the 2 standard deviation rule. Based on these assumptions, 60 patients per treatment group required to detect 30% treatment difference at 1-sided, 0.1 level of significance, with 80% power.||-0.809||0.3781
72339563|NCT00554099|144202802|SUPERIORITY_OR_OTHER||Mean Difference vs. Placebo|-1.4|STANDARD_ERROR_OF_MEAN|1.74||0.6285|ONE_SIDED|90.0||0.815|||ANCOVA|Fixed effects for treatment, number of diverticulitis attacks and baseline value as covariate.||It was assumed that the placebo treatment group and mesalamine treatment group would have an average composite score of 8.4 and 5.88 at Week 12, respectively. The common standard deviation was set to 4.5 based on the 2 standard deviation rule. Based on these assumptions, 60 patients per treatment group required to detect 30% treatment difference at 1-sided, 0.1 level of significance, with 80% power.||0.815||0.6285
72339564|NCT00554099|144202802|SUPERIORITY_OR_OTHER||Mean Difference vs. Asacol|1.6|STANDARD_ERROR_OF_MEAN|1.58||0.4365|ONE_SIDED|90.0||3.573|||ANCOVA|Fixed effects for treatment, number of diverticulitis attacks and baseline value as covariate.||It was assumed that the placebo treatment group and mesalamine treatment group would have an average composite score of 8.4 and 5.88 at Week 12, respectively. The common standard deviation was set to 4.5 based on the 2 standard deviation rule. Based on these assumptions, 60 patients per treatment group required to detect 30% treatment difference at 1-sided, 0.1 level of significance, with 80% power.||3.573||0.4365
72339565|NCT00554099|144202803|SUPERIORITY_OR_OTHER||Difference vs. Placebo|21.1|STANDARD_ERROR_OF_MEAN|12.53||0.0576|ONE_SIDED|90.0|5.1||||Cochran-Mantel-Haenszel|Stratified by number of diverticulitis attacks.|||||5.1|0.0576
72339566|NCT00554099|144202803|SUPERIORITY_OR_OTHER||Difference vs. Placebo|6.8|STANDARD_ERROR_OF_MEAN|13.27||0.3248|ONE_SIDED|90.0|-10.2||||Cochran-Mantel-Haenszel|Stratified by number of diverticulitis attacks.|||||-10.2|0.3248
72339567|NCT00554099|144202803|SUPERIORITY_OR_OTHER||Difference vs. Mesalamine|-14.4|STANDARD_ERROR_OF_MEAN|12.87||0.8596|ONE_SIDED|90.0|-30.8||||Cochran-Mantel-Haenszel|Stratified by number of diverticulitis attacks.|||||-30.8|0.8596
72339568|NCT00554099|144202804|SUPERIORITY_OR_OTHER||Difference vs. Placebo|16.7|STANDARD_ERROR_OF_MEAN|14.0||0.1266|ONE_SIDED|90.0|-1.3||||Cochran-Mantel-Haenszel|Stratified by number of diverticulitis attacks.|||||-1.3|0.1266
72339569|NCT00554099|144202804|SUPERIORITY_OR_OTHER||Difference vs. Placebo|-20.8|STANDARD_ERROR_OF_MEAN|14.13||0.9288|ONE_SIDED|90.0|-38.9||||Cochran-Mantel-Haenszel|Stratified by number of diverticulitis attacks.|||||-38.9|0.9288
72339570|NCT00554099|144202804|SUPERIORITY_OR_OTHER||Difference vs. Placebo|-37.5|STANDARD_ERROR_OF_MEAN|12.98||0.9962|ONE_SIDED|90.0|-54.1||||Cochran-Mantel-Haenszel|Stratified by number of diverticulitis attacks.|||||-54.1|0.9962
72339571|NCT00554099|144202805|SUPERIORITY_OR_OTHER||LS Mean Difference vs. Placebo|-1.4|STANDARD_ERROR_OF_MEAN|2.784||0.3082|ONE_SIDED|90.0||2.196|||ANOVA|Fixed effects for treatment and number of diverticulitis attacks.||||2.196||0.3082
72339572|NCT00554099|144202805|SUPERIORITY_OR_OTHER||LS Mean Difference vs. Placebo|0.083|STANDARD_ERROR_OF_MEAN|2.903||0.5113|ONE_SIDED|90.0||3.832|||ANOVA|Fixed effects for treatment and number of diverticulitis attacks.||||3.832||0.5113
72339573|NCT00554099|144202805|SUPERIORITY_OR_OTHER||LS Mean Difference vs. Mesalamine|1.483|STANDARD_ERROR_OF_MEAN|2.836||0.6988|ONE_SIDED|90.0||5.145|||ANOVA|Fixed effects for treatment and number of diverticulitis attacks.||||5.145||0.6988
72339574|NCT00554099|144202806|SUPERIORITY_OR_OTHER||LS Mean Difference vs. Placebo|-0.428|STANDARD_ERROR_OF_MEAN|3.067||0.4448|ONE_SIDED|90.0||3.541|||ANOVA|Fixed effects for treatment and number of diverticulitis attacks.||||3.541||0.4448
72339575|NCT00554099|144202806|SUPERIORITY_OR_OTHER||LS Mean Difference vs. Placebo|0.825|STANDARD_ERROR_OF_MEAN|3.151||0.6029|ONE_SIDED|90.0||4.903|||ANOVA|Fixed effects for treatment and number of diverticulitis attacks.||||4.903||0.6029
72339576|NCT00554099|144202806|SUPERIORITY_OR_OTHER||LS Mean Difference vs. Mesalamine|1.253|STANDARD_ERROR_OF_MEAN|2.996||0.6615|ONE_SIDED|90.0||5.129|||ANOVA|Fixed effects for treatment and number of diverticulitis attacks.||||5.129||0.6615
72339577|NCT00554099|144202807|SUPERIORITY_OR_OTHER||Difference vs. Placebo|2.6|STANDARD_ERROR_OF_MEAN|4.2||0.7165|ONE_SIDED|90.0||7.9|||Cochran-Mantel-Haenszel|Stratified by number of diverticulitis attacks.||||7.9||0.7165
72339578|NCT00554099|144202807|SUPERIORITY_OR_OTHER||Difference vs. Placebo|-2.4|STANDARD_ERROR_OF_MEAN|2.41||0.1708|ONE_SIDED|90.0||0.6|||Cochran-Mantel-Haenszel|Stratified by number of diverticulitis attacks.||||0.6||0.1708
72339579|NCT00554099|144202807|SUPERIORITY_OR_OTHER||Difference vs. Mesalamine|-5.0|STANDARD_ERROR_OF_MEAN|3.45||0.1039|ONE_SIDED|90.0||-0.6|||Cochran-Mantel-Haenszel|Stratified by number of diverticulitis attacks.||||-0.6||0.1039
72339580|NCT00554099|144202808|SUPERIORITY_OR_OTHER||Difference vs. Placebo|-7.5|STANDARD_ERROR_OF_MEAN|8.21||0.1907|ONE_SIDED|90.0||3.0|||Cochran-Mantel-Haenszel|Stratified by number of diverticulitis attacks.||||3.0||0.1907
72339581|NCT00554099|144202808|SUPERIORITY_OR_OTHER||Difference vs. Placebo|-8.2|STANDARD_ERROR_OF_MEAN|8.4||0.173|ONE_SIDED|90.0||2.5|||Cochran-Mantel-Haenszel|Stratified by number of diverticulitis attacks.||||2.5||0.1730
72339582|NCT00554099|144202808|SUPERIORITY_OR_OTHER||Difference vs. Mesalamine|-0.7|STANDARD_ERROR_OF_MEAN|7.61||0.4613|ONE_SIDED|90.0||9.0|||Cochran-Mantel-Haenszel|Stratified by number of diverticulitis attacks.||||9.0||0.4613
72339583|NCT00554099|144202809|SUPERIORITY_OR_OTHER||Difference vs. Placebo|-2.9|STANDARD_ERROR_OF_MEAN|11.7||0.3983|ONE_SIDED|90.0||12.1|||Cochran-Mantel-Haenszel|Stratified by number of diverticulitis attacks.||||12.1||0.3983
72339584|NCT00554099|144202809|SUPERIORITY_OR_OTHER||Difference vs. Placebo|6.0|STANDARD_ERROR_OF_MEAN|12.66||0.6721|ONE_SIDED|90.0||22.2|||Cochran-Mantel-Haenszel|Stratified by number of diverticulitis attacks.||||22.2||0.6721
72339585|NCT00554099|144202809|SUPERIORITY_OR_OTHER||Difference vs. Mesalamine|8.9|STANDARD_ERROR_OF_MEAN|12.23||0.7703|ONE_SIDED|90.0||24.6|||Cochran-Mantel-Haenszel|Stratified by number of diverticulitis attacks.||||24.6||0.7703
72339586|NCT02639338|144202821|SUPERIORITY|The p-value is obtained from the 2-sided exact 1-sample binomial test for the superiority over the performance goal of 83%.|||||<|0.001||||||The reported p-value was calculated. The statistical test was performed in SOF/VEL for 12 weeks at 0.05 significance level if and only if the statistical test performed in SOF/VEL/VOX for 8 weeks was significant at 0.05 significance level.|Binomial Test|||||||<0.001
72339587|NCT02639338|144202821|SUPERIORITY|The p-value is obtained from the 2-sided exact 1-sample binomial test for the superiority over the performance goal of 83%.|||||<|0.001||||||The reported p-value was calculated. The statistical test was performed in SOF/VEL for 12 weeks at 0.05 significance level if and only if the statistical test performed in SOF/VEL/VOX for 8 weeks was significant at 0.05 significance level.|2-sided exact 1-sample binomial test|||||||<0.001
72339588|NCT02008357|144202833|SUPERIORITY||LS Mean difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.26||0.26|TWO_SIDED|95.0|-0.816|0.22|||Natural Cubic Spline (NCS) method|||||0.220|-0.816|0.260
72339589|NCT02008357|144202835|SUPERIORITY||LS Mean difference (Final Values)|0.47|STANDARD_ERROR_OF_MEAN|0.28||0.1|TWO_SIDED|95.0|-0.089|1.02|||Natural Cubic Spline (NCS) method|||||1.020|-0.089|0.100
72339590|NCT02008357|144202837|SUPERIORITY||LS Mean difference (Final Values)|-0.59|STANDARD_ERROR_OF_MEAN|0.34||0.082|TWO_SIDED|95.0|-1.265|0.076|||Natural Cubic Spline (NCS) method|||||0.076|-1.265|0.082
72339591|NCT02008357|144202839|SUPERIORITY||LS Mean difference (Final Values)|-0.042|STANDARD_ERROR_OF_MEAN|0.0073|<|0.001|TWO_SIDED|95.0|-0.057|-0.028|||ANCOVA|||||-0.028|-0.057|<0.001
72339592|NCT02008357|144202840|SUPERIORITY||LS Mean difference (Final Values)|3.239|STANDARD_ERROR_OF_MEAN|32.8719||0.922|TWO_SIDED|95.0|-62.02|68.498|||ANCOVA|||Cerebrospinal fluid Tau Protein Immunoassay||68.498|-62.020|0.922
72339593|NCT02008357|144202840|SUPERIORITY||LS Mean difference (Final Values)|-0.965|STANDARD_ERROR_OF_MEAN|2.6535||0.717|TWO_SIDED|95.0|-6.241|4.311|||ANCOVA|||Cerebrospinal Fluid Phosphorylated Tau Protein Immunoassay||4.311|-6.241|0.717
72339594|NCT02008357|144202841|SUPERIORITY||LS Mean difference (Final Values)|12738.449|STANDARD_ERROR_OF_MEAN|998.7048|<|0.001|TWO_SIDED|95.0|10757.047|14719.851|||ANCOVA|||Cerebrospinal Fluid Amyloid Beta 1-40 Modified ELISA - INNOTEST||14719.851|10757.047|<0.001
72339595|NCT02008357|144202841|SUPERIORITY||LS Mean difference (Final Values)|996.411|STANDARD_ERROR_OF_MEAN|60.7404|<|0.001|TWO_SIDED|95.0|875.873|1116.948||p-value using ANCOVA model for endpoint measures: CHG = Baseline + APOE4 + AGE + Treatment.|ANCOVA|||Cerebrospinal Fluid Amyloid Beta 1-42 Mod Modified ELISA - INNOTEST||1116.948|875.873|<0.001
72339596|NCT02008357|144202842|SUPERIORITY||LS Mean difference (Final Values)|-0.054|STANDARD_ERROR_OF_MEAN|0.0388||0.161|TWO_SIDED|95.0|-0.131|0.022|||ANCOVA|||Total hippocampal volume||0.022|-0.131|0.161
72339597|NCT02008357|144202842|SUPERIORITY||LS Mean difference (Final Values)|0.351|STANDARD_ERROR_OF_MEAN|0.4513||0.437|TWO_SIDED|95.0|-0.535|1.236|||ANCOVA|||Total Lateral Ventricular Volume||1.236|-0.535|0.437
72339598|NCT01688921|144202867|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin was defined as the upper bound of the two-sided 95% CI of the GMT ratio (GMT with NS / GMT with PJ Stratis) for each antigen did not exceed 1.5 fold.|Geometric Mean Ratio|0.99|||||TWO_SIDED|95.0|0.88|1.12||||||For a sample size of 550 per group each test has an individual power of \> 99% to rule out the 1.5-fold difference using a two-sided α = 0.05, assuming equal GMTs between the two treatment groups. The overall power for the study to demonstrate the non-inferiority for the 6 co-primary endpoints is \> 80%, computed as product of 6 individual powers.||1.12|0.88|
72339599|NCT01688921|144202868|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin was defined as the upper bound of the two-sided 95% CI of the GMT ratio (GMT with NS / GMT with PJ Stratis) for each antigen did not exceed 1.5 fold.|Geometric Mean Ratio|1.08|||||TWO_SIDED|95.0|0.96|1.21||||||For a sample size of 550 per group each test has an individual power of \> 99% to rule out the 1.5-fold difference using a two-sided α = 0.05, assuming equal GMTs between the two treatment groups. The overall power for the study to demonstrate the non-inferiority for the 6 co-primary endpoints is \> 80%, computed as product of 6 individual powers.||1.21|0.96|
72368364|NCT01526733|144246748|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean Ratio|2.62|||<|0.0001|TWO_SIDED|90.0|2.08|3.29||Comparison of Day 4 Insulin (Aspart or Lispro)-rHuPH20 versus Day 1 Insulin-sham.|Mixed Models Analysis|A mixed model with fixed effects for treatment, day, and interaction of treatment with day was performed using a compound symmetric covariance matrix.||||3.29|2.08|<0.0001
72368365|NCT02395081|144246815|SUPERIORITY|||||||0.7||||||SBP wk 16-20|ANOVA|||||||0.70
72368366|NCT02395081|144246817|SUPERIORITY|||||||0.49|||||||Chi-squared|||||||0.49
72339600|NCT01688921|144202869|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin was defined as the upper bound of the two-sided 95% CI of the GMT ratio (GMT with NS / GMT with PJ Stratis) for each antigen did not exceed 1.5 fold.|Geometric Mean Ratio|0.94|||||TWO_SIDED|95.0|0.83|1.06||||||For a sample size of 550 per group each test has an individual power of \> 99% to rule out the 1.5-fold difference using a two-sided α = 0.05, assuming equal GMTs between the two treatment groups. The overall power for the study to demonstrate the non-inferiority for the 6 co-primary endpoints is \> 80%, computed as product of 6 individual powers.||1.06|0.83|
72339601|NCT01688921|144202870|NON_INFERIORITY_OR_EQUIVALENCE|Seroconversion rate defined as the proportion of subjects with either a pre-vaccination titer of \<10 achieving a post-vaccination antibody of HI titer of ≥ 40 or with a pre-vaccination HI titer of ≥ 10 achieving a four-fold or greater increase in post-vaccination HI titer. The non-inferiority margin was defined as the upper bound of the two-sided 95% CI on the difference between the seroconversion rates (rate with NS - with PJ Stratis) for each vaccine strain did not exceed 10 percentage points.|Seroconversion Rate Difference|0.8|||||TWO_SIDED|95.0|-4.8|6.5||||||For a sample size of 550 per group each test has an individual power of \> 95% to rule out the 10 percentage points difference using a one-sided α = 0.025, assuming equal seroconversion rates between the two treatment groups. The overall power for the study to demonstrate the non-inferiority for the 6 co-primary endpoints is \> 80%, computed as product of 6 individual powers.||6.5|-4.8|
72339602|NCT01688921|144202871|NON_INFERIORITY_OR_EQUIVALENCE|Seroconversion rate defined as the proportion of subjects with either a pre-vaccination titer of \<10 achieving a post-vaccination antibody of HI titer of ≥ 40 or with a pre-vaccination HI titer of ≥ 10 achieving a four-fold or greater increase in post-vaccination HI titer. The non-inferiority margin was defined as the upper bound of the two-sided 95% CI on the difference between the seroconversion rates(rate with NS - with PJ Stratis) for each vaccine strain did not exceed 10 percentage points|Seroconversion Rate Difference|1.3|||||TWO_SIDED|95.0|-4.5|7.1||||||For a sample size of 550 per group each test has an individual power of \> 95% to rule out the 10 percentage points difference using a one-sided α = 0.025, assuming equal seroconversion rates between the two treatment groups. The overall power for the study to demonstrate the non-inferiority for the 6 co-primary endpoints is \> 80%, computed as product of 6 individual powers.||7.1|-4.5|
72339603|NCT01688921|144202872|NON_INFERIORITY_OR_EQUIVALENCE|"Seroconversion rate was defined as the proportion of subjects with either a pre-vaccination titer of \<10 achieving a post-vaccination antibody of HI titer of ≥ 40 or with a pre-vaccination HI titer of ≥ 10 achieving a four-fold or greater increase in post-vaccination HI titer.~The upper-bound of the two-sided 95% CI on the difference in seroconversion rates for the A/H1N1, A/H3N2, and B strains did not exceed 10 percentage points (6.5, 7.1, and 5.9 respectively)."|Seroconversion Rate Difference|0.3|||||TWO_SIDED|95.0|-5.2|5.9||||||For a sample size of 550 per group each test has an individual power of \> 91% to rule out the 10 percentage points difference using a one-sided α = 0.025, assuming equal seroconversion rates between the two treatment groups. The overall power for the study to demonstrate the non-inferiority for the 6 co-primary endpoints is \> 80%, computed as product of 6 individual powers.||5.9|-5.2|
72339604|NCT01688921|144202873|NON_INFERIORITY_OR_EQUIVALENCE|Immediate adverse events were reported within 30 minutes of receiving the vaccination; therefore, they are all considered related to study treatment.|||||<|0.001|TWO_SIDED||||||Fisher Exact|||||||<0.001
72339605|NCT01688921|144202874|NON_INFERIORITY_OR_EQUIVALENCE|The safety population included subjects who received the vaccination and for whom follow-up data were available for a specific safety analysis. Therefore, the denominators for different safety tables vary, depending on the availability of the data.|||||<|0.001|TWO_SIDED||||||Fisher Exact|||||||<0.001
72339606|NCT02138240|144202880|OTHER|Pre-post comparison|||||<|0.001|||||||Wilcoxon signed rank sum|||||||<0.001
72339607|NCT02138240|144202883|OTHER|Pre-post comparison of baseline median weight to median weight at 6-month follow up||||||0.21|||||||Wilcoxon signed rank sum|||||||0.21
72339608|NCT00969436|144202884|NON_INFERIORITY|Non-inferiority with respect to seroconversion rates for measles 42-56 days after second vaccination dose was concluded if the lower limit (LL) of the two-sided standardised asymptotic 95% CI on the difference in the seroconversion rates between the two groups (Priorix-Tetra Group minus Control Group) was greater than or equal to (≥) -10%.|Difference in percentage|0.0|||||TWO_SIDED|95.0|-2.52|5.09||||||Non-inferiority of 2 doses of Priorix-Tetra® vaccine compared to Priorix™ vaccine followed by Priorix™ vaccine co-administered with Varilrix™ vaccine in terms of anti-measles seroconversion rates.||5.09|-2.52|
72339609|NCT00969436|144202884|NON_INFERIORITY|Non-inferiority with respect to seroconversion rates for mumps 42-56 days after second vaccination dose was concluded if the lower limit (LL) of the two-sided standardised asymptotic 95% CI on the difference in the seroconversion rates between the two groups (Priorix-Tetra Group minus Control Group) was greater than or equal to (≥) -10%.|Difference in percentage|0.0|||||TWO_SIDED|95.0|-2.52|5.09||||||Non-inferiority of 2 doses of Priorix-Tetra® vaccine compared to Priorix™ vaccine followed by Priorix™ vaccine co-administered with Varilrix™ vaccine in terms of anti-mumps seroconversion rates.||5.09|-2.52|
72339610|NCT00969436|144202884|NON_INFERIORITY|Non-inferiority with respect to seroconversion rates for rubella 42-56 days after second vaccination dose was concluded if the lower limit (LL) of the two-sided standardised asymptotic 95% CI on the difference in the seroconversion rates between the two groups (Priorix-Tetra Group minus Control Group) was greater than or equal to (≥) -10%.|Difference in percentage|0.0|||||TWO_SIDED|95.0|-2.51|5.02||||||Non-inferiority of 2 doses of Priorix-Tetra® vaccine compared to Priorix™ vaccine followed by Priorix™ vaccine co-administered with Varilrix™ vaccine in terms of anti-rubella seroconversion rates.||5.02|-2.51|
72339611|NCT00969436|144202884|NON_INFERIORITY|Non-inferiority with respect to seroconversion rates for varicella 42-56 days after second vaccination dose was concluded if the lower limit (LL) of the two-sided standardised asymptotic 95% CI on the difference in the seroconversion rates between the two groups (Priorix-Tetra Group minus Control Group) was greater than or equal to (≥) -10%.|Difference in percentage|4.17|||||TWO_SIDED|95.0|1.37|11.57||||||Non-inferiority of 2 doses of Priorix-Tetra® vaccine compared to Priorix™ vaccine followed by Priorix™ vaccine co-administered with Varilrix™ vaccine in terms of anti-varicella seroconversion rates.||11.57|1.37|
72368367|NCT02395081|144246818|SUPERIORITY|||||||0.79|||||||Chi-squared|||||||0.79
72368368|NCT02395081|144246820|SUPERIORITY|||||||0.83|||||||Chi-squared|||||||0.83
72368369|NCT02395081|144246821|SUPERIORITY|||||||0.39|||||||Chi-squared|||||||0.39
72339612|NCT00969436|144202884|NON_INFERIORITY|Non-inferiority with respect to seroconversion rates for measles 42-56 days after second vaccination dose was concluded if the lower limit (LL) of the 2-sided standardised asymptotic 95% confidence interval (CI) on the difference in the seroconversion rates between the 2 groups (Priorix/Priorix-Tetra Group minus Control Group) was ≥ -10%.|Difference in percentage|0.0|||||TWO_SIDED|95.0|-2.46|5.09||||||Non-inferiority of Priorix™ vaccine followed by Priorix-Tetra® vaccine compared to Priorix™ vaccine followed by Priorix™ vaccine co-administered with Varilrix™ vaccine in terms of anti-measles seroconversion rates.||5.09|-2.46|
72339613|NCT00969436|144202884|NON_INFERIORITY|Non-inferiority with respect to seroconversion rates for mumps 42-56 days after second vaccination dose was concluded if the lower limit (LL) of the 2-sided standardised asymptotic 95% confidence interval (CI) on the difference in the seroconversion rates between the 2 groups (Priorix/Priorix-Tetra Group minus Control Group) was ≥ -10%.|Difference in percentage|0.0|||||TWO_SIDED|95.0|-2.48|5.09||||||Non-inferiority of Priorix™ vaccine followed by Priorix-Tetra® vaccine compared to Priorix™ vaccine followed by Priorix™ vaccine co-administered with Varilrix™ vaccine in terms of anti-mumps seroconversion rates.||5.09|-2.48|
72339614|NCT00969436|144202884|NON_INFERIORITY|Non-inferiority with respect to seroconversion rates for rubella 42-56 days after second vaccination dose was concluded if the lower limit (LL) of the 2-sided standardised asymptotic 95% confidence interval (CI) on the difference in the seroconversion rates between the 2 groups (Priorix/Priorix-Tetra Group minus Control Group) was ≥ -10%.|Difference in percentage|0.0|||||TWO_SIDED|95.0|-2.48|5.02||||||Non-inferiority of Priorix™ vaccine followed by Priorix-Tetra® vaccine compared to Priorix™ vaccine followed by Priorix™ vaccine co-administered with Varilrix™ vaccine in terms of anti-rubella seroconversion rates.||5.02|-2.48|
72339615|NCT00969436|144202884|NON_INFERIORITY|Non-inferiority with respect to seroconversion rates for varicella 42-56 days after second vaccination dose was concluded if the lower limit (LL) of the 2-sided standardised asymptotic 95% confidence interval (CI) on the difference in the seroconversion rates between the 2 groups (Priorix/Priorix-Tetra Group minus Control Group) was ≥ -10%.|Difference in percentage|2.77|||||TWO_SIDED|95.0|-1.59|10.29||||||Non-inferiority of Priorix™ vaccine followed by Priorix-Tetra® vaccine compared to Priorix™ vaccine followed by Priorix™ vaccine co-administered with Varilrix™ vaccine in terms of anti-varicella seroconversion rates.||10.29|-1.59|
72339616|NCT02789410|144202895|SUPERIORITY|||||||0.132|||||||Wilcoxon (Mann-Whitney)|||||||0.132
72339617|NCT02789410|144202896|SUPERIORITY|||||||0.59|||||||Wilcoxon (Mann-Whitney)|||||||0.590
72339618|NCT02789410|144202897|SUPERIORITY|||||||0.971|||||||Wilcoxon (Mann-Whitney)|||||||0.971
72339619|NCT03159104|144202911|SUPERIORITY||Median Difference (Final Values)|5.0||||0.0113|TWO_SIDED|95.0|1.0|9.0|||Wilcoxon (Mann-Whitney)||Hodges-Lehmann estimator was used for the difference between median change of total scholastic skill score in each comparison group.|The difference between final and initial total scholastic skill score was calculated for each participant. Wilcoxon test was used for comparison of these differences because data distribution differs from normal.||9|1|0.0113
72339620|NCT03159104|144202912|SUPERIORITY||Median Difference (Final Values)|0.0||||0.0608|TWO_SIDED|95.0|0.0|5.0|||Wilcoxon (Mann-Whitney)||Hodges-Lehmann estimator was used for the difference between median change of total scholastic skill score in each comparison group.|||5|0|0.0608
72339621|NCT03159104|144202913|SUPERIORITY||Median Difference (Final Values)|0.0||||0.0824|TWO_SIDED|95.0|0.0|0.0|||Wilcoxon (Mann-Whitney)||Hodges-Lehmann estimator was used for the difference between median change of total scholastic skill score in each comparison group.|||0|0|0.0824
72339622|NCT03159104|144202914|SUPERIORITY||Median Difference (Final Values)|0.0||||0.2391|TWO_SIDED|95.0|0.0|1.0|||Wilcoxon (Mann-Whitney)||Hodges-Lehmann estimator was used for the difference between median change of total scholastic skill score in each comparison group.|||1|0|0.2391
72339623|NCT03159104|144202915|SUPERIORITY|||||||0.0033|||||||Fisher Exact|||||||0.0033
72339624|NCT03159104|144202916|SUPERIORITY|||||||0.0012|||||||Wilcoxon (Mann-Whitney)|||||||0.0012
72339625|NCT01999218|144202920|NON_INFERIORITY|Non-inferiority is declared if the upper bound of the two-sided 95% confidence interval (CI) for the mean difference is less than 0.3%.|Difference in the Least Squares Means|0.1|||||TWO_SIDED|95.0|-0.02|0.22|||||Constrained Longitudinal Data Analysis (cLDA) model with fixed effects for treatment, time, prior antihyperglycemic medication (monotherapy or dual therapy), baseline eGFR (continuous) and the interaction of time by treatment.|||0.22|-0.02|
72339626|NCT01999218|144202920|NON_INFERIORITY|Non-inferiority is declared if the upper bound of the two-sided 95% confidence interval (CI) for the mean difference is less than 0.3%.|Difference in the Least Squares means|0.18|||||TWO_SIDED|95.0|0.06|0.3|||||"Based on cLDA model with fixed effects for treatment, time, prior antihyperglycemic medication (monotherapy or dual therapy), baseline eGFR (continuous) and the interaction of time by treatment.~Time was treated as a categorical variable."|||0.30|0.06|
72339627|NCT01999218|144202921|OTHER|Based on Miettinen \& Nurminen method|Difference in % vs. Glimepiride|1.6|||||TWO_SIDED|95.0|-4.5|7.7||||||||7.7|-4.5|
72339628|NCT01999218|144202921|OTHER|Based on Miettinen \& Nurminen method|Difference in % vs. Glimepiride|0.5|||||TWO_SIDED|95.0|-5.6|6.5||||||||6.5|-5.6|
72339629|NCT01999218|144202922|OTHER||Difference in % vs. Glimepiride|3.0|||||TWO_SIDED|95.0|-0.3|6.4||||||||6.4|-0.3|
72339630|NCT01999218|144202922|OTHER||Difference in % vs. Glimepiride|1.5|||||TWO_SIDED|95.0|-1.7|4.7||||||||4.7|-1.7|
72339631|NCT01999218|144202923|OTHER||Difference in % vs. Glimepiride|-14.0|||<|0.001|TWO_SIDED|95.0|-18.4|-9.8|||Based on Miettinen & Nurminen method||||Based on Miettinen \& Nurminen method|-9.8|-18.4|<0.001
72339632|NCT01999218|144202923|OTHER||Difference in % vs. Glimepiride|-16.1|||<|0.001|TWO_SIDED|95.0|-20.3|-12.2|||Based on Miettinen & Nurminen method||||Based on Miettinen \& Nurminen method|-12.2|-20.3|<0.001
72339633|NCT01999218|144202924|OTHER||Difference in LSM vs. Glimepiride|-4.29|||<|0.001|TWO_SIDED|95.0|-4.77|-3.8|||Constrained Longitudinal Data analysis||LSM=Least Squares Means||Constrained Longitudinal Data analysis with fixed effects for treatment, time, interaction of time by treatment, prior antihyperglycemic medication (monotherapy or dual therapy), and baseline eGFR (continuous).|-3.80|-4.77|<0.001
72339634|NCT01999218|144202924|OTHER||Difference in the LSM vs. Glimepiride|-3.87|||<|0.001|TWO_SIDED|95.0|-4.36|-3.38|||Constrained Longitudinal Data Analysis||||Constrained Longitudinal Data Analysis with fixed effects for treatment, time, interaction of time by treatment, prior antihyperglycemic medication (monotherapy or dual therapy), and baseline eGFR (continuous).|-3.38|-4.36|<0.001
72368370|NCT02395081|144246822|SUPERIORITY|||||||0.24|||||||ANOVA|||||||0.24
72339635|NCT01999218|144202925|OTHER||Difference in the LSM vs. Glimepiride|-4.77|||<|0.001|TWO_SIDED|95.0|-6.29|-3.25|||Constrained Logitudinal Data Analysis||||Constrained Logitudinal Data Analysis with fixed effects for treatment, time, interaction of time by treatment, prior anthyperglycemic medication (monotherapy or dual therapy), and baseline eGFR (continuous).|-3.25|-6.29|<0.001
72339636|NCT01999218|144202925|OTHER||Difference in the LSM vs. Glimepiride|-3.2|||<|0.001|TWO_SIDED|0.001|-4.73|-1.67|||Constrained Logitudinal Data Analysis||||Constrained Logitudinal Data Analysis with fixed effects for treatment, time, interaction of time by treatment, prior anthyperglycemic medication (monotherapy or dual therapy), and baseline eGFR (continuous).|-1.67|-4.73|<0.001
72339637|NCT00734071|144202932|SUPERIORITY_OR_OTHER||LS Mean Difference|0.59|STANDARD_ERROR_OF_MEAN|0.911||0.518|TWO_SIDED|95.0|-1.2|2.38||Pre-specified sequential statistical testing procedure indicates that when p-value \>0.05, hierarchical testing stops and for subsequent endpoints in the sequence a nominal p-value is provided.|Mixed model for repeated measurements|||P-values were tested at the 5% level of significance (ie, statistical significance if P\<0.05). To control for multiplicity, a pre-specified sequential testing procedure was applied to compare 5 mg vortioxetine to placebo; as soon as an endpoint was non-significant at 0.05, the testing procedure stopped for all subsequent endpoints.||2.38|-1.20|0.518
72339638|NCT00734071|144202933|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.542||0.685|TWO_SIDED|95.0|-1.29|0.85||Hierarchical testing stopped at the primary endpoint in the testing sequence, a nominal p-value is provided.|Mixed model for repeated measurements|||Statistical tests were 2-sided and results were presented with 95% confidence intervals with the estimated P-values at the 5% level of significance (ie, statistical significance if P\<0.05).||0.85|-1.29|0.685
72339639|NCT00734071|144202934|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.141||0.984|TWO_SIDED|95.0|-0.27|0.28||Statistical tests were 2-sided and results were presented with 95% confidence intervals with the estimated P-values at the 5% level of significance (ie, statistical significance if P\<0.05). No adjustments for multiplicity were made.|Mixed model for repeated measurements|||||0.28|-0.27|0.984
72339640|NCT00734071|144202935|SUPERIORITY_OR_OTHER||LS Mean Difference|0.33|STANDARD_ERROR_OF_MEAN|0.866||0.703|TWO_SIDED|95.0|-1.38|2.04||Statistical tests were 2-sided and results were presented with 95% confidence intervals with the estimated P-values at the 5% level of significance (ie, statistical significance if P\<0.05). No adjustments for multiplicity were made.|Mixed model for repeated measurements|||||2.04|-1.38|0.703
72339641|NCT00734071|144202936|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.131||||0.602|TWO_SIDED|95.0|0.713|1.795|||Regression, Logistic|Logistic regression with explanatory variables for treatment and Baseline HAM-A score.||||1.795|0.713|0.602
72339642|NCT00734071|144202937|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|1.558||0.995|TWO_SIDED|95.0|-3.09|3.07||Statistical tests were 2-sided and results were presented with 95% confidence intervals with the estimated P-values at the 5% level of significance (ie, statistical significance if P\<0.05). No adjustments for multiplicity were made.|Mixed model for repeated measurements|||||3.07|-3.09|0.995
72339643|NCT00734071|144202938|SUPERIORITY_OR_OTHER||LS Mean Difference|1.02|STANDARD_ERROR_OF_MEAN|2.951||0.731|TWO_SIDED|95.0|-4.79|6.83||Statistical tests were 2-sided and results were presented with 95% confidence intervals with the estimated P-values at the 5% level of significance (ie, statistical significance if P\<0.05). No adjustments for multiplicity were made.|Mixed model for repeated measurements|||||6.83|-4.79|0.731
72339644|NCT00541346|144202959|SUPERIORITY_OR_OTHER||Bayesian Mean Change Score|26.3|||<|0.001|TWO_SIDED|95.0|19.6|33.1||Posterior-Predictive Probability of Mean Change (Pre-Post) Score at or Below Zero.|Mixed Models Analysis|Bayesian random intercept model.|The confidence interval listed is a Bayesian credible interval which represents the probabilistic likelihood that the population mean change falls within these bounds.|Random intercept growth curves were fit to all outcome data, including intermediate assessments. A Bayesian posterior-predictive mean change score and its associated 95% credible interval were estimated using the MCMC Gibbs sampler with non-informative priors. Models included linear and quadratic dose effects, effect for compliance, baseline Life Participation Scale (LPS) effect, LPS by compliance interaction, a functional time component, and interaction between LPS and time.||33.1|19.6|<0.001
72339645|NCT00541346|144202960|SUPERIORITY_OR_OTHER||Bayesian Mean Change Score|23.1|||<|0.001|TWO_SIDED|95.0|16.9|29.3||Posterior-Predictive Probability of Mean Change Score (Pre-Post) at or Below Zero.|Mixed Models Analysis|Bayesian random intercept model.|The confidence interval listed is a Bayesian credible interval which represents the probabilistic likelihood that the population mean change falls within these bounds.|Random intercept growth curves were fit to all outcome data, including intermediate assessments. A Bayesian posterior-predictive mean change score and its associated 95% credible interval were estimated using the MCMC Gibbs sampler with non-informative priors. Models included linear and quadratic dose effects, effect for compliance, baseline Life Participation Scale (LPS) effect, LPS by compliance interaction, a functional time component, and interaction between LPS and time.||29.3|16.9|<0.001
72339646|NCT00541346|144202961|SUPERIORITY_OR_OTHER||Bayesian Mean Change Score|10.9|||<|0.001|TWO_SIDED|95.0|5.4|16.8||Posterior-Predictive Probability of Mean Change Score (Pre-Post) at or Below Zero.|Mixed Models Analysis|Bayesian random intercept model.||Random intercept growth curves were fit to all outcome data, including intermediate assessments. A Bayesian posterior-predictive mean change score and its associated 95% credible interval were estimated using the MCMC Gibbs sampler with non-informative priors. Models included linear and quadratic dose effects, effect for compliance, baseline Life Participation Scale (LPS) effect, LPS by compliance interaction, a functional time component, and interaction between LPS and time.||16.8|5.4|<0.001
72339647|NCT00541346|144202962|SUPERIORITY_OR_OTHER||Bayesian Mean Change Score|7.2|||<|0.001|TWO_SIDED|95.0|3.3|11.1||Posterior-Predictive Probability of Mean Change Score (Pre-Post) at or Below Zero.|Mixed Models Analysis|Bayesian random intercept model.|The confidence interval listed is a Bayesian credible interval which represents the probabilistic likelihood that the population mean change falls within these bounds.|Random intercept growth curves were fit to all outcome data, including intermediate assessments. A Bayesian posterior-predictive mean change score and its associated 95% credible interval were estimated using the MCMC Gibbs sampler with non-informative priors. Models included linear and quadratic dose effects, effect for compliance, baseline Life Participation Scale (LPS) effect, LPS by compliance interaction, a functional time component, and interaction between LPS and time.||11.1|3.3|<0.001
72368371|NCT02395081|144246823|SUPERIORITY|||||||0.39|||||||Chi-squared|||||||0.39
72339648|NCT00541346|144202963|SUPERIORITY_OR_OTHER||Bayesian Mean Change Score|4.1|||<|0.01||95.0|1.2|6.9||Posterior-Predictive Probability of Mean Change Score (Pre-Post) at or Below Zero.|Mixed Models Analysis|Bayesian random intercept model.|The confidence interval listed is a Bayesian credible interval which represents the probabilistic likelihood that the population mean change falls within these bounds.|Random intercept growth curves were fit to all outcome data, including intermediate assessments. A Bayesian posterior-predictive mean change score and its associated 95% credible interval were estimated using the MCMC Gibbs sampler with non-informative priors. Models included linear and quadratic dose effects, effect for compliance, baseline Life Participation Scale (LPS) effect, LPS by compliance interaction, a functional time component, and interaction between LPS and time.||6.9|1.2|<0.01
72339649|NCT00541346|144202964|SUPERIORITY_OR_OTHER||Bayesian random intercept model.|3.5|||<|0.001|TWO_SIDED|95.0|1.8|5.2||Posterior-Predictive Probability of Mean Change Score (Pre-Post) at or Below Zero.|Mixed Models Analysis|Bayesian random intercept model.|The confidence interval listed is a Bayesian credible interval which represents the probabilistic likelihood that the population mean change falls within these bounds|Random intercept growth curves were fit to all outcome data, including intermediate assessments. A Bayesian posterior-predictive mean change score and its associated 95% credible interval were estimated using the MCMC Gibbs sampler with non-informative priors. Models included linear and quadratic dose effects, effect for compliance, baseline Life Participation Scale (LPS) effect, LPS by compliance interaction, a functional time component, and interaction between LPS and time.||5.2|1.8|<0.001
72339650|NCT00541346|144202965|SUPERIORITY_OR_OTHER||Bayesian Mean Change Score|-10.9|||<|0.001|TWO_SIDED|95.0|-16.8|-5.4||Posterior-Predictive Probability of Mean Change Score (Pre-Post) at or Above Zero.|Mixed Models Analysis|Bayesian random intercept model.|The confidence interval listed is a Bayesian credible interval which represents the probabilistic likelihood that the population mean change falls within these bounds|Random intercept growth curves were fit to all outcome data. A Bayesian posterior-predictive mean change score and its associated 95% credible interval were estimated using the MCMC Gibbs sampler with non-informative priors. Models included linear dose and time effects.||-5.4|-16.8|<0.001
72339651|NCT00541346|144202966|SUPERIORITY_OR_OTHER||Bayesian Mean Change Score|1.94|||>|0.21|TWO_SIDED|95.0|-2.98|6.82||Posterior-Predictive Probability of Mean Change Score (Pre-Post) at or Below Zero.|Mixed Models Analysis|Bayesian random intercept model.|The confidence interval listed is a Bayesian credible interval which represents the probabilistic likelihood that the population mean change falls within these bounds.|Random intercept growth curves were fit to all outcome data, including intermediate assessments. A Bayesian posterior-predictive mean change score and its associated 95% credible interval were estimated using the MCMC Gibbs sampler with non-informative priors. Models included linear and quadratic dose effects, effect for compliance, baseline Life Participation Scale (LPS) effect, LPS by compliance interaction, a functional time component, and interaction between LPS and time.||6.82|-2.98|>0.21
72339652|NCT00541346|144202967|SUPERIORITY_OR_OTHER||Bayesian Mean Change Score|-3.4|||>|0.06|TWO_SIDED|95.0|-7.9|0.8||Posterior-Predictive Probability of Mean Change Score (Pre-Post) at or Above Zero.|Mixed Models Analysis|Bayesian random intercept model.|The confidence interval listed is a Bayesian credible interval which represents the probabilistic likelihood that the population mean change falls within these bounds.|Random intercept growth curves were fit to all outcome data. A Bayesian posterior-predictive mean change score and its associated 95% credible interval were estimated using the MCMC Gibbs sampler with non-informative priors. Models included linear dose and time effects.||0.80|-7.9|>0.06
72339653|NCT00541346|144202968|SUPERIORITY_OR_OTHER||Bayesian Mean Change Score|-5.26|||<|0.01|TWO_SIDED|95.0|-9.37|-1.18||Posterior-Predictive Probability of Mean Change Score (Pre-Post) at or Above Zero.|Mixed Models Analysis|Bayesian random intercept model.|The confidence interval listed is a Bayesian credible interval which represents the probabilistic likelihood that the population mean change falls within these bounds.|Random intercept growth curves were fit to all outcome data. A Bayesian posterior-predictive mean change score and its associated 95% credible interval were estimated using the MCMC Gibbs sampler with non-informative priors. Models included linear dose and time effects.||-1.18|-9.37|<0.01
72339654|NCT00541346|144202969|SUPERIORITY_OR_OTHER||Bayesian Mean Change Score|7.6|||>|0.11|TWO_SIDED|95.0|-5.6|20.7||Posterior-Predictive Probability of Mean Change Score (Pre-Post) at or Below Zero.|Mixed Models Analysis|Bayesian random intercept model.|The confidence interval listed is a Bayesian credible interval which represents the probabilistic likelihood that the population mean change falls within these bounds.|Random intercept growth curves were fit to all outcome data, including intermediate assessments. A Bayesian posterior-predictive mean change score and its associated 95% credible interval were estimated using the MCMC Gibbs sampler with non-informative priors. Models included linear and quadratic dose effects, effect for compliance, baseline Life Participation Scale (LPS) effect, LPS by compliance interaction, a functional time component, and interaction between LPS and time.||20.7|-5.6|>0.11
72339655|NCT04732949|144202970|OTHER||Hazard Ratio (HR)|1.06||||0.509|TWO_SIDED|95.0|0.89|1.27|||Cox proportional hazard model|||Hazard Ratio for time to hospital discharge - SNG001 vs Placebo||1.27|0.89|0.509
72339656|NCT04732949|144202971|OTHER||Hazard Ratio (HR)|1.02||||0.888|TWO_SIDED|95.0|0.81|1.28|||Cox proportional hazard model|||Hazard Ratio for time to OSCI recovery - SNG001 vs Placebo||1.28|0.81|0.888
72339657|NCT04732949|144202972|OTHER||Odds Ratio (OR)|0.71||||0.161|TWO_SIDED|95.0|0.44|1.15|||Regression, Logistic|||Odds Ratio for progression to severe disease or death - SNG001 vs Placebo||1.15|0.44|0.161
72339658|NCT04732949|144202973|OTHER||Odds Ratio (OR)|0.85||||0.61|TWO_SIDED|95.0|0.45|1.61|||Regression, Logistic|||Odds Ratio for intubation or death - SNG001 vs Placebo||1.61|0.45|0.610
72339659|NCT04732949|144202974|OTHER||Odds Ratio (OR)|0.79||||0.544|TWO_SIDED|95.0|0.38|1.67|||Regression, Logistic|||Odds Ratio for death - SNG001 vs Placebo||1.67|0.38|0.544
72339660|NCT04732949|144202975|OTHER||Odds Ratio (OR)|1.18||||0.323|TWO_SIDED|95.0|0.85|1.64|||Regression, Logistic|||Odds Ratio for hospital discharge (Day 7) - SNG001 vs Placebo||1.64|0.85|0.323
72428389|NCT01327547|144367746|SUPERIORITY_OR_OTHER||Difference in LS Mean|10.87||||0.7697|TWO_SIDED|95.0|-62.44|84.18|||ANCOVA||Difference in LS Mean|The above analysis is for D-Dimer cells at Week 96. Results are from an ANCOVA model with change from baseline as the response variable and the following fixed effect model terms: treatment (Maraviroc or placebo), baseline value of the response variable, HBV, PI-based regimen.||84.18|-62.44|0.7697
72339661|NCT04732949|144202975|OTHER||Odds Ratio (OR)|1.17||||0.406|TWO_SIDED|95.0|0.81|1.7|||Regression, Logistic|||Odds Ratio for hospital discharge (Day 14) - SNG001 vs Placebo||1.70|0.81|0.406
72339662|NCT04732949|144202975|OTHER||Odds Ratio (OR)|0.96||||0.828|TWO_SIDED|95.0|0.64|1.43|||Regression, Logistic|||Odds Ratio for hospital discharge (Day 21) - SNG001 vs Placebo||1.43|0.64|0.828
72339663|NCT04732949|144202975|OTHER||Odds Ratio (OR)|0.92||||0.706|TWO_SIDED|95.0|0.61|1.4|||Regression, Logistic|||Odds Ratio for hospital discharge (Day 28) - SNG001 vs Placebo||1.40|0.61|0.706
72339664|NCT04732949|144202976|OTHER||Odds Ratio (OR)|1.71||||0.101|TWO_SIDED|95.0|0.9|3.22|||Regression, Logistic|||Odds Ratio for OSCI recovery (Day 7) - SNG001 vs Placebo||3.22|0.90|0.101
72339665|NCT04732949|144202976|OTHER||Odds Ratio (OR)|0.99||||0.942|TWO_SIDED|95.0|0.67|1.45|||Regression, Logistic|||Odds Ratio for OSCI recovery (Day 14) - SNG001 vs Placebo||1.45|0.67|0.942
72339666|NCT04732949|144202976|OTHER||Odds Ratio (OR)|0.96||||0.824|TWO_SIDED|95.0|0.68|1.35|||Regression, Logistic|||Odds Ratio for OSCI recovery (Day 21) - SNG001 vs Placebo||1.35|0.68|0.824
72339667|NCT04732949|144202976|OTHER||Odds Ratio (OR)|0.92||||0.613|TWO_SIDED|95.0|0.66|1.28|||Regression, Logistic|||Odds Ratio for OSCI recovery (Day 28) - SNG001 vs Placebo||1.28|0.66|0.613
72339668|NCT04732949|144202978|OTHER||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.12||0.41|TWO_SIDED|95.0|-0.1|0.3|||Mixed Models Analysis|||SNG001 vs Placebo||0.3|-0.1|0.410
72339669|NCT02853435|144202995|OTHER||Ratio of geometric LS means|1.0417|||||TWO_SIDED|90.0|0.9809|1.1063|||||A mixed effects model with treatment, sequence, period as fixed effects and participant within sequence as random effect was performed on the natural log-transformed parameters AUC(0-inf).|||1.1063|0.9809|
72339670|NCT02853435|144202995|OTHER||Ratio of geometric LS means|1.1108|||||TWO_SIDED|90.0|1.0459|1.1797|||||A mixed effects model with treatment, sequence, period as fixed effects and participant within sequence as random effect was performed on the natural log-transformed parameters AUC(0-inf).|||1.1797|1.0459|
72339671|NCT02853435|144202996|OTHER||Ratio of geometric LS means|1.0408|||||TWO_SIDED|90.0|0.9792|1.1062|||||A mixed effects model with treatment, sequence, period as fixed effects and participant within sequence as random effect was performed on the natural log-transformed parameters AUC(0-t).|||1.1062|0.9792|
72339672|NCT02853435|144202996|OTHER||Ratio of geometric LS means|1.1138|||||TWO_SIDED|90.0|1.0479|1.1838|||||A mixed effects model with treatment, sequence, period as fixed effects and participant within sequence as random effect was performed on the natural log-transformed parameters AUC(0-t).|||1.1838|1.0479|
72339673|NCT02853435|144202998|OTHER||Ratio of geometric LS means|0.9586|||||TWO_SIDED|90.0|0.844|1.0888|||||A mixed effects model with treatment, sequence, period as fixed effects and participant within sequence as random effect was performed on the natural log-transformed parameters Cmax.|||1.0888|0.8440|
72339674|NCT02853435|144202998|OTHER||Ratio of geometric LS means|1.1487|||||TWO_SIDED|90.0|1.0113|1.3047|||||A mixed effects model with treatment, sequence, period as fixed effects and participant within sequence as random effect was performed on the natural log-transformed parameters Cmax.|||1.3047|1.0113|
72339675|NCT02853435|144202999|OTHER||Median Difference (Final Values)|-0.233||||0.309|TWO_SIDED|90.0|-0.267|0.0||The p-value is from Wilcoxon signed-rank test.|Wilcoxon signed-rank test.||The median, median difference and 90% CI of the median difference are from Hodge-Lehmann estimate.|||0.000|-0.267|0.309
72339676|NCT02853435|144202999|OTHER||Median Difference (Final Values)|-0.492|||<|0.001|TWO_SIDED|90.0|-0.5|-0.25||The p-value is from Wilcoxon signed-rank test.|Wilcoxon signed-rank test.||The median, median difference and 90% CI of the median difference are from Hodge-Lehmann estimate.|||-0.250|-0.500|<0.001
72339677|NCT00996801|144203116|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-1.96||||0.012|TWO_SIDED|95.0|-3.58|-0.35||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||-0.35|-3.58|0.012
72339678|NCT00996801|144203116|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-1.81||||0.019|TWO_SIDED|95.0|-3.37|-0.25||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||-0.25|-3.37|0.019
72339679|NCT00996801|144203116|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-1.82||||0.019|TWO_SIDED|95.0|-3.23|-0.41||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||-0.41|-3.23|0.019
72339680|NCT00996801|144203117|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-2.64|||<|0.001|TWO_SIDED|95.0|-3.9|-1.38||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||-1.38|-3.90|<0.001
72339681|NCT00996801|144203117|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-2.62|||<|0.001|TWO_SIDED|95.0|-3.83|-1.4||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||-1.40|-3.83|<0.001
72339682|NCT00996801|144203117|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-2.12|||<|0.001|TWO_SIDED|95.0|-3.22|-1.02||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||-1.02|-3.22|<0.001
72339683|NCT00996801|144203117|SUPERIORITY_OR_OTHER||Difference in Least Square Means|-0.74||||0.376|TWO_SIDED|95.0|-1.99|0.52||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||0.52|-1.99|0.376
72339684|NCT00996801|144203117|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-0.71||||0.376|TWO_SIDED|95.0|-1.93|0.5||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||0.50|-1.93|0.376
72339685|NCT00996801|144203117|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-0.22||||0.699|TWO_SIDED|95.0|-1.32|0.88||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||0.88|-1.32|0.699
72339686|NCT00996801|144203118|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-2.04||||0.002|TWO_SIDED|95.0|-3.43|-0.64||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||-0.64|-3.43|0.002
72339687|NCT00996801|144203118|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-1.29||||0.035|TWO_SIDED|95.0|-2.48|-0.09||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||-0.09|-2.48|0.035
72339688|NCT00996801|144203118|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-1.76||||0.009|TWO_SIDED|95.0|-3.14|-0.38||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||-0.38|-3.14|0.009
72339689|NCT00996801|144203118|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-0.86||||0.335|TWO_SIDED|95.0|-2.26|0.54||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||0.54|-2.26|0.335
72339690|NCT00996801|144203118|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-0.11||||0.857|TWO_SIDED|95.0|-1.3|1.08||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||1.08|-1.30|0.857
72339691|NCT00996801|144203118|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-0.59||||0.542|TWO_SIDED|95.0|-1.96|0.79||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||0.79|-1.96|0.542
72339692|NCT00996801|144203119|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-3.24|||<|0.001|TWO_SIDED|95.0|-4.91|-1.57||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||-1.57|-4.91|<0.001
72339693|NCT00996801|144203119|SUPERIORITY_OR_OTHER||Difference in Least Square Means|-3.18|||<|0.001|TWO_SIDED|95.0|-4.78|-1.57||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||-1.57|-4.78|<0.001
72339694|NCT00996801|144203119|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-3.2|||<|0.001|TWO_SIDED|95.0|-4.66|-1.74||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||-1.74|-4.66|<0.001
72339695|NCT00996801|144203119|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-1.27||||0.18|TWO_SIDED|95.0|-2.93|0.4||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||0.40|-2.93|0.180
72339696|NCT00996801|144203119|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-1.2||||0.18|TWO_SIDED|95.0|-2.81|0.4||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||0.40|-2.81|0.180
72339697|NCT00996801|144203119|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-1.22||||0.18|TWO_SIDED|95.0|-2.68|0.23||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||0.23|-2.68|0.180
72339698|NCT00996801|144203120|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-1.36||||0.001|TWO_SIDED|95.0|-2.18|-0.54||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||-0.54|-2.18|0.001
72339699|NCT00996801|144203120|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-1.51||||0.001|TWO_SIDED|95.0|-2.46|-0.55||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||-0.55|-2.46|0.001
72339700|NCT00996801|144203120|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-1.92|||<|0.001|TWO_SIDED|95.0|-2.93|-0.91||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||-0.91|-2.93|<0.001
72339701|NCT00996801|144203120|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-0.37||||0.383|TWO_SIDED|95.0|-1.21|0.46||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||0.46|-1.21|0.383
72339702|NCT00996801|144203120|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-0.52||||0.383|TWO_SIDED|95.0|-1.49|0.45||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||0.45|-1.49|0.383
72339703|NCT00996801|144203120|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-0.94||||0.084|TWO_SIDED|95.0|-1.96|0.09||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||0.09|-1.96|0.084
72339704|NCT00996801|144203121|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-0.47||||0.68|TWO_SIDED|95.0|-1.88|0.94||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||0.94|-1.88|0.680
72339705|NCT00996801|144203121|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-0.01||||0.993|TWO_SIDED|95.0|-1.3|1.28||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||1.28|-1.30|0.993
72339706|NCT00996801|144203121|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-1.1||||0.23|TWO_SIDED|95.0|-2.67|0.46||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||0.46|-2.67|0.230
72339707|NCT00996801|144203121|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-0.84||||0.333|TWO_SIDED|95.0|-2.29|0.61||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||0.61|-2.29|0.333
72339708|NCT00996801|144203121|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-0.37||||0.577|TWO_SIDED|95.0|-1.69|0.94||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||0.94|-1.69|0.577
72339709|NCT00996801|144203121|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-1.47||||0.078|TWO_SIDED|95.0|-3.07|0.12||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||0.12|-3.07|0.078
72339710|NCT00996801|144203122|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-1.99||||0.094|TWO_SIDED|95.0|-4.22|0.25||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||0.25|-4.22|0.094
72339711|NCT00996801|144203122|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-1.66||||0.157|TWO_SIDED|95.0|-3.82|0.5||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||0.50|-3.82|0.157
72339712|NCT00996801|144203122|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-1.57||||0.157|TWO_SIDED|95.0|-3.53|0.38||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||0.38|-3.53|0.157
72339713|NCT00996801|144203122|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-0.43||||0.937|TWO_SIDED|95.0|-2.61|1.76||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||1.76|-2.61|0.937
72339714|NCT00996801|144203122|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-0.1||||0.992|TWO_SIDED|95.0|-2.21|2.01||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||2.01|-2.21|0.992
72339715|NCT00996801|144203122|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-0.01||||0.992|TWO_SIDED|95.0|-1.93|1.9||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||1.90|-1.93|0.992
72339716|NCT00996801|144203123|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-0.47||||0.824|TWO_SIDED|95.0|-2.5|1.56||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||1.56|-2.50|0.824
72339717|NCT00996801|144203123|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-0.42||||0.824|TWO_SIDED|95.0|-2.28|1.43||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||1.43|-2.28|0.824
72339718|NCT00996801|144203123|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-0.96||||0.624|TWO_SIDED|95.0|-3.23|1.31||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||1.31|-3.23|0.624
72339719|NCT00996801|144203123|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|0.78||||0.7|TWO_SIDED|95.0|-1.25|2.82||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||2.82|-1.25|0.700
72339720|NCT00996801|144203123|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|0.83||||0.7|TWO_SIDED|95.0|-1.39|3.06||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||3.06|-1.39|0.700
72339721|NCT00996801|144203123|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|0.3||||0.759|TWO_SIDED|95.0|-1.6|2.19||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||2.19|-1.60|0.759
72339722|NCT00996801|144203124|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-16.22||||0.227|TWO_SIDED|95.0|-39.15|6.72||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||6.72|-39.15|0.227
72339723|NCT00996801|144203124|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|1.85||||0.853|TWO_SIDED|95.0|-17.9|21.61||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||21.61|-17.90|0.853
72339724|NCT00996801|144203124|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-13.14||||0.327|TWO_SIDED|95.0|-35.67|9.39||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||9.39|-35.67|0.327
72339725|NCT00996801|144203124|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-2.74||||0.94|TWO_SIDED|95.0|-23.91|18.43||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||18.43|-23.91|0.940
72339726|NCT00996801|144203124|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|15.33||||0.273|TWO_SIDED|95.0|-7.86|38.52||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||38.52|-7.86|0.273
72339727|NCT00996801|144203124|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|0.33||||0.973|TWO_SIDED|95.0|-19.23|19.9||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||19.90|-19.23|0.973
72339728|NCT00996801|144203125|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-1.48||||0.01|TWO_SIDED|95.0|-2.66|-0.29||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||-0.29|-2.66|0.010
72339729|NCT00996801|144203125|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-1.14||||0.053|TWO_SIDED|95.0|-2.29|0.01||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||0.01|-2.29|0.053
72339730|NCT00996801|144203125|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-1.15||||0.053|TWO_SIDED|95.0|-2.19|-0.11||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||-0.11|-2.19|0.053
72339731|NCT00996801|144203125|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-0.58||||0.509|TWO_SIDED|95.0|-1.77|0.6||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||0.60|-1.77|0.509
72339732|NCT00996801|144203125|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-0.25||||0.843|TWO_SIDED|95.0|-1.27|0.77||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||0.77|-1.27|0.843
72339733|NCT00996801|144203125|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-0.26||||0.843|TWO_SIDED|95.0|-1.43|0.92||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||0.92|-1.43|0.843
72339734|NCT00996801|144203126|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|86.33|||<|0.001|TWO_SIDED|95.0|64.87|108.29||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Constrained Longitudinal Data Analysis|||||108.29|64.87|<0.001
72339735|NCT00996801|144203126|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|82.14|||<|0.001|TWO_SIDED|95.0|63.0|101.66||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Constrained Longitudinal Data Analysis|||||101.66|63.00|<0.001
72339736|NCT00996801|144203126|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|107.26|||<|0.001|TWO_SIDED|95.0|82.03|133.23||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Constrained Longitudinal Data Analysis|||||133.23|82.03|<0.001
72339737|NCT00996801|144203126|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|22.87||||0.104|TWO_SIDED|95.0|-3.8|49.68||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Constrained Longitudinal Data Analysis|||||49.68|-3.80|0.104
72339738|NCT00996801|144203126|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|18.68||||0.123|TWO_SIDED|95.0|-5.11|42.56||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Constrained Longitudinal Data Analysis|||||42.56|-5.11|0.123
72339739|NCT00996801|144203126|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|43.8||||0.003|TWO_SIDED|95.0|12.85|75.06||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Constrained Longitudinal Data Analysis|||||75.06|12.85|0.003
72339740|NCT00996801|144203127|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|187.31|||<|0.001|TWO_SIDED|95.0|154.44|221.25||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Constrained Longitudinal Data Analysis|||||221.25|154.44|<0.001
72339741|NCT00996801|144203127|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|200.29|||<|0.001|TWO_SIDED|95.0|161.21|240.91||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Constrained Longitudinal Data Analysis|||||240.91|161.21|<0.001
72339742|NCT00996801|144203127|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|224.3|||<|0.001|TWO_SIDED|95.0|180.19|270.39||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Constrained Longitudinal Data Analysis|||||270.39|180.19|<0.001
72339743|NCT00996801|144203127|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|48.29||||0.034|TWO_SIDED|95.0|3.75|93.11||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Constrained Longitudinal Data Analysis|||||93.11|3.75|0.034
72368372|NCT02395081|144246824|SUPERIORITY|||||||0.89|||||||Chi-squared|||||||0.89
72368373|NCT02395081|144246825|SUPERIORITY|||||||0.95|||||||Chi-squared|||||||0.95
72368374|NCT01869764|144246837|OTHER|||||||0.93|||||||ANOVA|||||||0.93
72339744|NCT00996801|144203127|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|61.27||||0.019|TWO_SIDED|95.0|8.8|114.22||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Constrained Longitudinal Data Analysis|||||114.22|8.80|0.019
72339745|NCT00996801|144203127|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|85.28||||0.002|TWO_SIDED|95.0|26.7|144.63||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Constrained Longitudinal Data Analysis|||||144.63|26.70|0.002
72339746|NCT00996801|144203128|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|133.03|||<|0.001|TWO_SIDED|95.0|110.01|156.75||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Constrained Longitudinal Data Analysis|||||156.75|110.01|<0.001
72339747|NCT00996801|144203128|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|133.03||||0.001|TWO_SIDED|95.0|110.01|156.75||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Constrained Longitudinal Data Analysis|||||156.75|110.01|0.001
72339748|NCT00996801|144203128|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|131.53|||<|0.001|TWO_SIDED|95.0|110.7|152.94||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Constrained Longitudinal Data Analysis|||||152.94|110.70|<0.001
72339749|NCT00996801|144203128|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|169.8|||<|0.001|TWO_SIDED|95.0|141.59|199.11||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Constrained Longitudinal Data Analysis|||||199.11|141.59|<0.001
72339750|NCT00996801|144203128|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|58.57|||<|0.001|TWO_SIDED|95.0|29.42|88.04||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Constrained Longitudinal Data Analysis|||||88.04|29.42|<0.001
72339751|NCT00996801|144203128|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|57.07|||<|0.001|TWO_SIDED|95.0|30.76|83.64||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Constrained Longitudinal Data Analysis|||||83.64|30.76|<0.001
72428390|NCT01327547|144367746|SUPERIORITY_OR_OTHER||Difference in LS Mean|-24.49||||0.5816|TWO_SIDED|95.0|-112.21|63.23|||ANCOVA||Difference in LS Mean|The above analysis is for D-Dimer cells at Week 144. Results are from an ANCOVA model with change from baseline as the response variable and the following fixed effect model terms: treatment (Maraviroc or placebo), baseline value of the response variable, HBV, PI-based regimen.||63.23|-112.21|0.5816
72339752|NCT00996801|144203128|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|95.34|||<|0.001|TWO_SIDED|95.0|60.4|130.91||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Constrained Longitudinal Data Analysis|||||130.91|60.40|<0.001
72339753|NCT00996801|144203129|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|53.86|||<|0.001|TWO_SIDED|95.0|39.31|68.6||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Constrained Longitudinal Data Analysis|||||68.60|39.31|<0.001
72339754|NCT00996801|144203129|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|53.81|||<|0.001|TWO_SIDED|95.0|41.37|66.38||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Constrained Longitudinal Data Analysis|||||66.38|41.37|<0.001
72339755|NCT00996801|144203129|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|55.47|||<|0.001|TWO_SIDED|95.0|41.19|69.94||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Constrained Longitudinal Data Analysis|||||69.94|41.19|<0.001
72339756|NCT00996801|144203129|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|20.53||||0.009|TWO_SIDED|95.0|5.96|35.03||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Constrained Longitudinal Data Analysis|||||35.03|5.96|0.009
72339757|NCT00996801|144203129|SUPERIORITY_OR_OTHER||Difference in Least Mean Squares|20.47||||0.009|TWO_SIDED|95.0|5.96|35.03||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Constrained Longitudinal Data Analysis|||||35.03|5.96|0.009
72339758|NCT00996801|144203129|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|22.13||||0.009|TWO_SIDED|95.0|4.47|39.89||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Constrained Longitudinal Data Analysis|||||39.89|4.47|0.009
72368375|NCT01869764|144246838|OTHER|||||||0.29|||||||ANOVA|||||||0.29
72368376|NCT00298558|144246916|SUPERIORITY_OR_OTHER||Effect Size|0.06||||0.43|TWO_SIDED|99.0|-0.14|0.27|||Mixed Models Analysis|The blom transformation was used to reduce skewness in the measures. The design factors and baseline covariates were controlled in the model.|Blom transformed outcome was used and the design factors and baseline covariates were controlled in the model to get the adjusted means. After that, the effect size (defined in the Additional details) was calculated using the adjusted means and SD.|Effect size was defined as training improvement from baseline to year 10 minus control improvement from baseline to year 10 divided by the intrasubject standard deviation (SD) of the composite score. Positive effect sizes indicate improvement.||0.27|-0.14|0.43
72428391|NCT01327547|144367747|SUPERIORITY_OR_OTHER||Difference in LS Mean|498.04||||0.3786|TWO_SIDED|95.0|-617.33|1613.41|||ANCOVA||Difference in LS Mean|The above analysis is for TGF-beta cells at Week 48. Results are from an ANCOVA model with change from baseline as the response variable and the following fixed effect model terms: treatment (Maraviroc or placebo), baseline value of the response variable, HBV, PI-based regimen.||1613.41|-617.33|0.3786
72339759|NCT04172467|144203135|OTHER|To estimate the relevance of guideline adherent treatment (GLAD) for the susceptibility to infection, full GLAD is taken as reference category.|Hazard Ratio (HR)|4.49|||<|0.001|TWO_SIDED|95.0|3.72|5.42||For effect estimation, hazard ratios are reported with 95% confidence interval. The significance level is set to two-sided ≤ 5% (p ≤ 0.05).|Regression, Cox|The Model developed by Anderson and Gill (1982) is an extension to the proportional hazard model (Cox model) for time to recurrent event analysis.||For the analysis of susceptibility to infection, the time to next infection was examined using the Andersen-Gill model. This model is an extension to the proportional hazard model (Cox model) for time to recurrent event analysis. The null hypothesis is that the GLAD-Score has no effect on susceptibility to infection.||5.42|3.72|<0.001
72339760|NCT04172467|144203135|OTHER|To estimate the relevance of guideline adherent treatment (GLAD) for the susceptibility to infection, full GLAD is taken as reference category.|Hazard Ratio (HR)|2.52|||<|0.001|TWO_SIDED|95.0|1.98|3.21||For effect estimation, hazard ratios are reported with 95% confidence interval. The significance level is set to two-sided ≤ 5% (p ≤ 0.05).|Regression, Cox|The Model developed by Anderson and Gill (1982) is an extension to the proportional hazard model (Cox model) for time to recurrent event analysis.||For the analysis of susceptibility to infection, the time to next infection was examined using the Andersen-Gill model. This model is an extension to the proportional hazard model (Cox model) for time to recurrent event analysis. The null hypothesis is that the GLAD-Score has no effect on susceptibility to infection.||3.21|1.98|<0.001
72339761|NCT03369431|144203150|SUPERIORITY|||||||0.784|||||||t-test, 2 sided|||"Null hypothesis is that there is no difference in the percentage change from baseline in the ATEC Total between Vivomixx and Placebo.~A sample size of 72 participants was needed to determine an effect size of 0.50 with 80% power, with a type 1 error of 5% using a two-sided test. This calculation is based on the assumed effect size of the primary outcome measure, the ATEC. The minimally clinically important difference based on the primary outcome measure with this instrument was 15 points."||||0.784
72339762|NCT03369431|144203151|SUPERIORITY|||||||0.357|||||||Wilcoxon (Mann-Whitney)|Related-samples Wilcoxon Signed Rank||Null hypothesis is that there is no difference in the change from baseline in frequency of Abdominal Pain between Vivomixx and Placebo.||||0.357
72339763|NCT03369431|144203151|SUPERIORITY|||||||0.29|||||||Wilcoxon (Mann-Whitney)|Related-samples Wilcoxon Signed Rank||Null hypothesis is that there is no difference in the change from baseline in frequency of Gaseousness between Vivomixx and Placebo.||||0.290
72339764|NCT03369431|144203151|SUPERIORITY|||||||0.418|||||||Wilcoxon (Mann-Whitney)|Related-samples Wilcoxon Signed Rank||Null hypothesis is that there is no difference in the change from baseline in frequency of Diarrhoea between Vivomixx and Placebo.||||0.418
72339765|NCT03369431|144203151|SUPERIORITY|||||||0.734|||||||Wilcoxon (Mann-Whitney)|Related-samples Wilcoxon Signed Rank||Null hypothesis is that there is no difference in the change from baseline in frequency of Constipation between Vivomixx and Placebo.||||0.734
72339766|NCT03369431|144203151|SUPERIORITY|||||||0.362|||||||Wilcoxon (Mann-Whitney)|Related-samples Wilcoxon Signed Rank||Null hypothesis is that there is no difference in the change from baseline in frequency of Pain on Stooling between Vivomixx and Placebo.||||0.362
72428392|NCT01327547|144367747|SUPERIORITY_OR_OTHER||Difference in LS Mean|348.7||||0.4388|TWO_SIDED|95.0|-539.61|1237.01|||ANCOVA||Difference in LS Mean|The above analysis is for TGF-beta cells at Week 96. Results are from an ANCOVA model with change from baseline as the response variable and the following fixed effect model terms: treatment (Maraviroc or placebo), baseline value of the response variable, HBV, PI-based regimen.||1237.01|-539.61|0.4388
72339767|NCT03369431|144203151|SUPERIORITY|||||||0.705|||||||Wilcoxon (Mann-Whitney)|Related-samples Wilcoxon Signed Rank||Null hypothesis is that there is no difference in the change from baseline in frequency of Difficulty Swallowing between Vivomixx and Placebo.||||0.705
72339768|NCT03369431|144203151|SUPERIORITY|||||||0.589|||||||Wilcoxon (Mann-Whitney)|Related-samples Wilcoxon Signed Rank||Null hypothesis is that there is no difference in change from baseline in frequency of vomiting between Vivomixx and placebo||||0.589
72339769|NCT03369431|144203151|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|Related-samples Wilcoxon signed rank||Null hypothesis is that there is no difference in change from baseline in frequency of blood in stool between Vivomixx and placebo||||1.0
72339770|NCT03369431|144203151|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|Related-samples Wilcoxon signed rank||Null hypothesis is that there is no difference in change from baseline in frequency of blood in vomit between Vivomixx and placebo||||1.0
72339771|NCT03369431|144203152|SUPERIORITY|||||||0.635|||||||Wilcoxon (Mann-Whitney)|Related-samples Wilcoxon Signed Rank||Null hypothesis is that there is no difference in the change from baseline of ABC Irritability score between Vivomixx and Placebo||||0.635
72339772|NCT03369431|144203152|SUPERIORITY|||||||0.367|||||||Wilcoxon (Mann-Whitney)|Related-samples Wilcoxon Signed Rank||The null hypothesis is that there is no difference in the change from baseline of ABC Lethargy/social withdrawal score between Vivomixx and Placebo.||||0.367
72339773|NCT03369431|144203152|SUPERIORITY|||||||0.609|||||||Wilcoxon (Mann-Whitney)|Related-samples Wilcoxon Signed Rank||Null hypothesis is that there is no difference in the change from baseline in the ABC Stereotypic behaviour between Vivomixx and Placebo.||||0.609
72339774|NCT03369431|144203152|SUPERIORITY|||||||0.805|||||||t-test, 2 sided|Paired samples t-test||Null hypothesis is that there is no difference in the change from baseline of the ABC Hyperactivity/Noncompliance between Vivomixx and Placebo.||||0.805
72339775|NCT03369431|144203152|SUPERIORITY|||||||0.985|||||||Wilcoxon (Mann-Whitney)|Related-samples Wilcoxon Signed Rank test used.||Null hypothesis is that there is no difference in the change from baseline of the ABC Inappropriate Speech between Vivomixx and Placebo.||||0.985
72339776|NCT03369431|144203153|SUPERIORITY|||||||0.661|||||||Wilcoxon (Mann-Whitney)|Related-samples Wilcoxon Signed Rank||||||0.661
72339777|NCT04271475|144203162|SUPERIORITY||Least square mean|-16.1|STANDARD_ERROR_OF_MEAN|8.2||0.974|TWO_SIDED|95.0|-32.34|0.16|||MMRM||Least square mean and SE of the mean was estimated by mixed model repeated measurements method.|||0.16|-32.34|0.974
72339778|NCT00159913|144203169|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|7.71|STANDARD_ERROR_OF_MEAN|3.98||0.056||95.0|-0.19|15.6||No adjustments for multiple comparisons have been made.|ANCOVA|Analyses performed using analysis of covariance with etiology, weight and baseline peak VO2 as the covariates.||||15.60|-0.19|0.056
72339779|NCT00159913|144203169|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|3.81|STANDARD_ERROR_OF_MEAN|5.0||||95.0|-6.11|13.73|||ANCOVA|Analyses performed using analysis of covariance with etiology, weight and baseline peak VO2 as the covariates.||||13.73|-6.11|
72339780|NCT00159913|144203169|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|11.33|STANDARD_ERROR_OF_MEAN|4.84||||95.0|1.72|20.94|||ANCOVA|Analyses performed using analysis of covariance with etiology, weight and baseline peak VO2 as the covariates.||||20.94|1.72|
72339781|NCT00159913|144203169|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|7.98|STANDARD_ERROR_OF_MEAN|4.85||||95.0|-1.64|17.6|||ANCOVA|Analyses performed using analysis of covariance with etiology, weight and baseline peak VO2 as the covariates.||||17.60|-1.64|
72339782|NCT00159913|144203170|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.1|STANDARD_ERROR_OF_MEAN|2.2||0.172||95.0|-7.5|1.3|||ANCOVA|Covariates:etiology, wt grp, capability performing exercise test. Normality assumptions not met with main analysis: alternative=excluding outliers||||1.3|-7.5|0.172
72339783|NCT00159913|144203170|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.6|STANDARD_ERROR_OF_MEAN|3.1||||95.0|-4.5|7.6|||ANCOVA|Covariates:etiology, wt grp, capability performing exercise test. Normality assumptions not met with main analysis: alternative=excluding outliers||||7.6|-4.5|
72339784|NCT00159913|144203170|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.5|STANDARD_ERROR_OF_MEAN|2.7||||95.0|-8.9|1.9|||ANCOVA|Covariates:etiology, wt grp, capability performing exercise test. Normality assumptions not met with main analysis: alternative=excluding outliers||||1.9|-8.9|
72339785|NCT00159913|144203170|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-7.3|STANDARD_ERROR_OF_MEAN|2.6||||95.0|-12.4|-2.1|||ANCOVA|Covariates:etiology, wt grp, capability performing exercise test. Normality assumptions not met with main analysis: alternative=excluding outliers||||-2.1|-12.4|
72339786|NCT00159913|144203171|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.1|STANDARD_ERROR_OF_MEAN|2.0||0.041||95.0|-8.0|-0.2|||ANCOVA|Covariates:etiology, wt grp, capability performing exercise test. Normality assumptions not met w/ main analysis: alternative=natural log transformed||||-0.2|-8.0|0.041
72339787|NCT00159913|144203171|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|2.7||||95.0|-5.9|4.7|||ANCOVA|Covariates:etiology, wt grp, capability performing exercise test. Normality assumptions not met w/ main analysis: alternative=natural log transformed||||4.7|-5.9|
72339788|NCT00159913|144203171|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.5|STANDARD_ERROR_OF_MEAN|2.4||||95.0|-9.3|0.3|||ANCOVA|Covariates:etiology, wt grp, capability performing exercise test. Normality assumptions not met w/ main analysis: alternative=natural log transformed||||0.3|-9.3|
72339789|NCT00159913|144203171|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-7.2|STANDARD_ERROR_OF_MEAN|2.3||||95.0|-11.7|-2.7|||ANCOVA|Covariates:etiology, wt grp, capability performing exercise test. Normality assumptions not met w/ main analysis: alternative=natural log transformed||||-2.7|-11.7|
72339790|NCT00159913|144203172|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.61|STANDARD_ERROR_OF_MEAN|2.36||0.795||95.0|-4.07|5.3|||ANCOVA|The model included the covariates etiology and weight group||||5.30|-4.07|0.795
72339791|NCT00159913|144203172|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.62|STANDARD_ERROR_OF_MEAN|2.99||||95.0|-3.31|8.54|||ANCOVA|The model included the covariates etiology and weight group||||8.54|-3.31|
72339792|NCT00159913|144203172|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.29|STANDARD_ERROR_OF_MEAN|2.92||||95.0|-7.09|4.5|||ANCOVA|The model included the covariates etiology and weight group||||4.50|-7.09|
72339793|NCT00159913|144203172|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.52|STANDARD_ERROR_OF_MEAN|2.9||||95.0|-5.24|6.28|||ANCOVA|The model included the covariates etiology and weight group||||6.28|-5.24|
72339794|NCT00159913|144203173|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|9.24|STANDARD_ERROR_OF_MEAN|6.2||0.139||95.0|-3.05|21.54|||ANCOVA|The model included the covariates etiology and weight group||||21.54|-3.05|0.139
72339795|NCT00159913|144203173|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|10.34|STANDARD_ERROR_OF_MEAN|7.84||||95.0|-5.21|25.9|||ANCOVA|The model included the covariates etiology and weight group||||25.90|-5.21|
72339796|NCT00159913|144203173|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|11.43|STANDARD_ERROR_OF_MEAN|7.67||||95.0|-3.78|26.64|||ANCOVA|The model included the covariates etiology and weight group||||26.64|-3.78|
72339797|NCT00159913|144203173|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.96|STANDARD_ERROR_OF_MEAN|7.62||||95.0|-9.16|21.08|||ANCOVA|The model included the covariates etiology and weight group||||21.08|-9.16|
72339798|NCT00159913|144203174|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.9|STANDARD_ERROR_OF_MEAN|2.1||0.172||95.0|-7.1|1.3|||ANCOVA|The model included the covariates etiology, weight group and capability of performing the exercise test||||1.3|-7.1|0.172
72339799|NCT00159913|144203174|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|2.9||||95.0|-5.5|5.9|||ANCOVA|The model included the covariates etiology, weight group and capability of performing the exercise test||||5.9|-5.5|
72339800|NCT00159913|144203174|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.4|STANDARD_ERROR_OF_MEAN|2.6||||95.0|-8.5|1.7|||ANCOVA|The model included the covariates etiology, weight group and capability of performing the exercise test||||1.7|-8.5|
72339801|NCT00159913|144203174|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.5|STANDARD_ERROR_OF_MEAN|2.4||||95.0|-10.3|-0.7|||ANCOVA|The model included the covariates etiology, weight group and capability of performing the exercise test||||-0.7|-10.3|
72339802|NCT00159913|144203175|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.74|STANDARD_ERROR_OF_MEAN|0.3||0.015||95.0|0.14|1.34|||ANCOVA|The model included the covariates etiology, weight group and capability of performing the exercise test||||1.34|0.14|0.015
72339803|NCT00159913|144203175|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.71|STANDARD_ERROR_OF_MEAN|0.41||||95.0|-0.1|1.52|||ANCOVA|The model included the covariates etiology, weight group and capability of performing the exercise test||||1.52|-0.10|
72339804|NCT00159913|144203175|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.61|STANDARD_ERROR_OF_MEAN|0.37||||95.0|-0.12|1.35|||ANCOVA|The model included the covariates etiology, weight group and capability of performing the exercise test||||1.35|-0.12|
72339805|NCT00159913|144203175|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.89|STANDARD_ERROR_OF_MEAN|0.35||||95.0|0.21|1.58|||ANCOVA|The model included the covariates etiology, weight group and capability of performing the exercise test||||1.58|0.21|
72339806|NCT00159913|144203176|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|0.64||0.44||95.0|-1.77|0.77|||ANCOVA|The model included the covariates etiology, weight group and capability of performing the exercise test||||0.77|-1.77|0.440
72339807|NCT00159913|144203176|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.17|STANDARD_ERROR_OF_MEAN|0.88||||95.0|-1.91|1.57|||ANCOVA|The model included the covariates etiology, weight group and capability of performing the exercise test||||1.57|-1.91|
72339808|NCT00159913|144203176|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.19|STANDARD_ERROR_OF_MEAN|0.78||||95.0|-1.73|1.36|||ANCOVA|The model included the covariates etiology, weight group and capability of performing the exercise test||||1.36|-1.73|
72339809|NCT00159913|144203176|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.14|STANDARD_ERROR_OF_MEAN|0.75||||95.0|-2.61|0.33|||ANCOVA|The model included the covariates etiology, weight group and capability of performing the exercise test||||0.33|-2.61|
72339810|NCT00159913|144203177|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.62|STANDARD_ERROR_OF_MEAN|1.93||0.75||95.0|-4.45|3.21|||ANCOVA|The covariates included in the model were baseline scale, etiology, weight and capability of performing the exercise test.||||3.21|-4.45|0.750
72339811|NCT00159913|144203177|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.87|STANDARD_ERROR_OF_MEAN|2.57||||95.0|-4.21|5.95|||ANCOVA|||||5.95|-4.21|
72339812|NCT00159913|144203177|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.24|STANDARD_ERROR_OF_MEAN|2.49||||95.0|-4.68|5.15|||ANCOVA|||||5.15|-4.68|
72339813|NCT00159913|144203177|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.96|STANDARD_ERROR_OF_MEAN|2.23||||95.0|-7.37|1.45|||ANCOVA|||||1.45|-7.37|
72339814|NCT00159913|144203178|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.42|STANDARD_ERROR_OF_MEAN|1.51||0.784||95.0|-3.41|2.58|||ANCOVA|The covariates included in the model were baseline scale, etiology, weight and capability of performing the exercise test.||||2.58|-3.41|0.784
72339815|NCT00159913|144203178|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.41|STANDARD_ERROR_OF_MEAN|1.97||||95.0|-3.49|4.3|||ANCOVA|||||4.30|-3.49|
72339816|NCT00159913|144203178|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.11|STANDARD_ERROR_OF_MEAN|1.96||||95.0|-5.99|1.77|||ANCOVA|||||1.77|-5.99|
72339817|NCT00159913|144203178|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.46|STANDARD_ERROR_OF_MEAN|1.77||||95.0|-3.06|3.97|||ANCOVA|||||3.97|-3.06|
72339818|NCT00159913|144203179|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.83||||0.184||95.0|0.75|4.45|||Regression, Logistic|Proportional odds method. Model covariates were baseline WHO functional class, etiology, weight group and capability of performing the exercise test.||||4.45|0.75|0.184
72339819|NCT00159913|144203179|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.6||||0.409||95.0|0.18|2.01|||Regression, Logistic|Proportional odds method. Model covariates were baseline WHO functional class, etiology, weight group and capability of performing the exercise test.||||2.01|0.18|0.409
72339820|NCT00159913|144203179|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.25||||0.146||95.0|0.75|6.69|||Regression, Logistic|Proportional odds method. Model covariates were baseline WHO functional class, etiology, weight group and capability of performing the exercise test.||||6.69|0.75|0.146
72339821|NCT00159913|144203179|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|4.52||||0.006||95.0|1.56|13.1|||Regression, Logistic|Proportional odds method. Model covariates were baseline WHO functional class, etiology, weight group and capability of performing the exercise test.||||13.10|1.56|0.006
72339822|NCT00159913|144203180|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.89|STANDARD_ERROR_OF_MEAN|4.35||0.179||95.0|-2.74|14.53|||ANCOVA|Analyses performed using analysis of covariance with etiology, weight and baseline peak VO2 as the covariates||||14.53|-2.74|0.179
72339823|NCT00159913|144203180|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.14|STANDARD_ERROR_OF_MEAN|5.35||||95.0|-9.49|11.77|||ANCOVA|Analyses performed using analysis of covariance with etiology, weight and baseline peak VO2 as the covariates||||11.77|-9.49|
72339824|NCT00159913|144203180|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|11.3|STANDARD_ERROR_OF_MEAN|5.36||||95.0|0.66|21.96|||ANCOVA|Analyses performed using analysis of covariance with etiology, weight and baseline peak VO2 as the covariates||||21.96|0.66|
72339825|NCT00159913|144203180|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.24|STANDARD_ERROR_OF_MEAN|5.16||||95.0|-5.02|15.5|||ANCOVA|Analyses performed using analysis of covariance with etiology, weight and baseline peak VO2 as the covariates||||15.50|-5.02|
72339826|NCT01318070|144203191|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.179|||||TWO_SIDED|95.0|-0.224|-0.135||||||||-0.135|-0.224|
72339827|NCT01318070|144203191|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.18|||||TWO_SIDED|95.0|-0.225|-0.135||||||||-0.135|-0.225|
72339828|NCT01318070|144203192|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.363|||||TWO_SIDED|95.0|-0.434|-0.292||||||||-0.292|-0.434|
72339829|NCT01318070|144203192|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.359|||||TWO_SIDED|95.0|-0.432|-0.287||||||||-0.287|-0.432|
72339830|NCT01318070|144203193|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.588|||||TWO_SIDED|95.0|-0.692|-0.484||||||||-0.484|-0.692|
72339831|NCT01318070|144203193|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.635|||||TWO_SIDED|95.0|-0.743|-0.526||||||||-0.526|-0.743|
72339832|NCT01318070|144203194|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.83|||||TWO_SIDED|95.0|-13.2|-4.47||||||||-4.47|-13.20|
72339833|NCT01318070|144203194|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.06|||||TWO_SIDED|95.0|-17.86|-8.26||||||||-8.26|-17.86|
72339834|NCT01318070|144203195|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.24|||||TWO_SIDED|95.0|-16.22|-6.25||||||||-6.25|-16.22|
72339835|NCT01318070|144203195|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.82|||||TWO_SIDED|95.0|-20.0|-9.63||||||||-9.63|-20.00|
72339836|NCT01318070|144203196|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.88|||||TWO_SIDED|95.0|-18.09|-7.68||||||||-7.68|-18.09|
72339837|NCT01318070|144203196|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.08|||||TWO_SIDED|95.0|-22.64|-11.53||||||||-11.53|-22.64|
72339838|NCT01318070|144203197|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.46|||||TWO_SIDED|95.0|-18.51|-6.4||||||||-6.40|-18.51|
72339839|NCT01318070|144203197|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.49|||||TWO_SIDED|95.0|-22.78|-10.19||||||||-10.19|-22.78|
72339840|NCT01318070|144203198|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.31|||||TWO_SIDED|95.0|-21.51|-3.1||||||||-3.10|-21.51|
72339841|NCT01318070|144203198|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-21.19|||||TWO_SIDED|95.0|-30.43|-11.95||||||||-11.95|-30.43|
72339842|NCT01318070|144203199|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.717|||||TWO_SIDED|95.0|-0.848|-0.586||||||||-0.586|-0.848|
72339843|NCT01318070|144203199|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.773|||||TWO_SIDED|95.0|-0.913|-0.634||||||||-0.634|-0.913|
72339844|NCT01173029|144203200|NON_INFERIORITY_OR_EQUIVALENCE|Study power calculation was post-hoc based on composite end-point achieved. Number of exposed: 62 Non-exposed to exposed ratio: 0.5 Relative risk worth detecting: 2.5 Attack rate among non-exposed: 23% Alpha risk: 0.05 Calculated power: 89.8%|Risk Ratio (RR)|1.7||||0.19|TWO_SIDED|95.0|0.7|4.1||not adjusted|Chi-squared, Corrected|1 degree-of-freedom||"Long-term intention-to-treat data analysis:~Student 't' tests Yates's corrected Chi-squared or Fisher's exact test, when appropriate Relative risk estimation Cox proportional-hazard model Hardy-Weinberg equilibrium"||4.1|0.7|0.19
72339845|NCT01173029|144203201|NON_INFERIORITY_OR_EQUIVALENCE|Study power calculation was post-hoc based on composite end-point achieved. Number of exposed: 62 Non-exposed to exposed ratio: 0.5 Relative risk worth detecting: 2.5 Attack rate among non-exposed: 23% Alpha risk: 0.05 Calculated power: 89.8%|Risk Ratio (RR)|2.6||||0.01|TWO_SIDED|95.0|1.01|7.3||not adjusted|Chi-squared, Corrected|1 degree-of-freedom||"Long-term intention-to-treat data analysis:~Student 't' test Yates' corrected Chi-squared or Fisher's exact test Relative risk estimation Cox proportional-hazard model Hardy-Weinberg equilibrium"||7.3|1.01|0.01
72339846|NCT01173029|144203201|NON_INFERIORITY_OR_EQUIVALENCE|Proportional-risk hypothesis was tested using the correlation between Schoenfeld's residuals and time (Schoenfeld's global test). The correlation rho was -0.08, Chi-squared was 0.12, and p was 0.73. Therefore, the hypothesis of proportional risk was accepted, validating the correct application model.|Hazard Ratio (HR)|2.2||||0.04|TWO_SIDED|95.0|1.1|4.8||The p-value was adjusted for confounders: Framingham risk score, body mass index, ethnic groups|Regression, Cox|The actuarial function of events per time since the first diagnosis of arterial hypertension was plotted for both groups.||Cox proportional hazard model for the composite endpoint (stroke + myocardial infarction) was assessed. By taking pseudo-resistant arterial hypertension as baseline reference, the hazard ratio for the composite endpoint was calculated.||4.8|1.1|0.04
72339847|NCT01173029|144203202|SUPERIORITY_OR_OTHER||C-statistic|0.66|||<|0.01|TWO_SIDED|95.0|0.56|0.76||At an optimal value of \>3, polygenic risk score yielded 90% sensitivity and 40% specificity for composite endpoint.|z test|Area under receiver operating characteristic curve.|The optimal cutoff value for polygenic risk score was set to \>3.|Receiver operating characteristic curve analysis for the polygenic score as predictor of composite endpoint (stroke + myocardial infarction)||0.76|0.56|<0.01
72339848|NCT01173029|144203202|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.9||||0.04|TWO_SIDED|95.0|1.2|9.2||The p-value was adjusted for confounders: Framingham risk score, body mass index, ethnic group|Regression, Cox|The actuarial function of events per time since the first diagnosis of arterial hypertension was plotted for polygenic risk score\<=3 and \>3.||Cox proportional hazard model of the polygenic risk score\<=3 and \> 3 for the composite endpoint (stroke + myocardial infarction). By taking polygenic risk score\<=3, the hazard ratio for the composite endpoint was calculated for polygenic risk score\>3 .||9.2|1.2|0.04
72339849|NCT00870194|144203210|NON_INFERIORITY_OR_EQUIVALENCE|Non-Inferiority Margin of 0.4%||||||0.012||95.0|||||Mixed Model Repeated Measures|||||||.012
72339850|NCT00870194|144203210|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin of 0.4%|Least Square Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|0.12||0.012|TWO_SIDED|95.0|0.07|0.53|||Mixed Model Repeated Measures||Standard Error of the Least Square Mean|Power calculation: 80% assuming 200 patients (100 in each arm), no true difference and 1.0% standard deviation.||0.53|0.07|.012
72339851|NCT00870194|144203211|SUPERIORITY_OR_OTHER|||||||0.038||95.0|||||Fisher's Exact Test|||||||.038
72339852|NCT00870194|144203212|SUPERIORITY_OR_OTHER|||||||0.027||95.0|||||Fisher's Exact Test|||||||.027
72339853|NCT00870194|144203213|SUPERIORITY_OR_OTHER|||||||0.48||95.0|||||Fisher's Exact Test|||||||.480
72339854|NCT00870194|144203214|SUPERIORITY_OR_OTHER|||||||0.038||95.0|||||ANCOVA|||||||.038
72339855|NCT00870194|144203215|SUPERIORITY_OR_OTHER|||||||0.266||95.0|||||Mixed Model Repeated Measures|||||||.266
72339856|NCT00870194|144203216|SUPERIORITY_OR_OTHER|||||||0.095||95.0|||||Mixed Model Repeated Measures|||||||.095
72339857|NCT00870194|144203217|SUPERIORITY_OR_OTHER|||||||0.567||95.0|||||Mixed Model Repeated Measures|||||||.567
72339858|NCT00870194|144203218|SUPERIORITY_OR_OTHER|||||||0.207||95.0|||||Mixed Model Repeated Measures|||||||.207
72339859|NCT00870194|144203219|SUPERIORITY_OR_OTHER|||||||0.055||95.0|||||ANCOVA|||||||.055
72339860|NCT00870194|144203220|SUPERIORITY_OR_OTHER|||||||0.269||95.0|||||ANCOVA|||||||.269
72339861|NCT00870194|144203221|SUPERIORITY_OR_OTHER|||||||0.622||95.0|||||ANCOVA|||||||.622
72339862|NCT00870194|144203222|SUPERIORITY_OR_OTHER|||||||0.888||95.0|||||ANCOVA|||||||.888
72339863|NCT00870194|144203223|SUPERIORITY_OR_OTHER|||||||0.287||95.0|||||Fisher's Exact Test|||||||.287
72339864|NCT00870194|144203224|SUPERIORITY_OR_OTHER|||||||0.498||95.0|||||Fisher's Exact Test|||||||.498
72339865|NCT00870194|144203225|SUPERIORITY_OR_OTHER|||||||0.247||95.0|||||Fisher's Exact Test|||||||.247
72339866|NCT00870194|144203226|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher's Exact Test|||||||1.00
72428393|NCT01327547|144367747|SUPERIORITY_OR_OTHER||Difference in LS Mean|-173.57||||0.8559|TWO_SIDED|95.0|-2060.81|1713.68|||ANCOVA||Difference in LS Mean|The above analysis is for TGF-beta cells at Week 144. Results are from an ANCOVA model with change from baseline as the response variable and the following fixed effect model terms: treatment (Maraviroc or placebo), baseline value of the response variable, HBV, PI-based regimen.||1713.68|-2060.81|0.8559
72339867|NCT01443130|144203241|SUPERIORITY_OR_OTHER|||||||0.2441||||||A Bonferroni correction was used due to multiple comparisons. Comparisons are statistically significant if the two-sided p-value is ≤ 0.05/2=0.025|Fisher Exact|||The null hypothesis is the incidence of placental malaria infection based on histology is identical between subjects receiving maternal chloroquine prophylaxis vs. maternal SP IPT.||||0.2441
72339868|NCT01443130|144203241|SUPERIORITY_OR_OTHER|||||||1||||||A Bonferroni correction was used due to multiple comparisons. Comparisons are statistically significant if the two-sided p-value is ≤ 0.05/2=0.025|Fisher Exact|||The null hypothesis is the incidence of placental malaria infection based on histology is identical between subjects receiving maternal chloroquine IPT vs. maternal SP IPT.||||1.000
72339869|NCT01443130|144203242|SUPERIORITY_OR_OTHER|||||||0.4941||||||A Bonferroni correction was used due to multiple comparisons. Comparisons are statistically significant if the two-sided p-value is ≤ 0.05/2=0.025.|Fisher Exact|||The null hypothesis is the incidence of malaria by placental impression smear is identical between subjects receiving maternal chloroquine prophylaxis vs. maternal SP IPT.||||0.4941
72339870|NCT01443130|144203242|SUPERIORITY_OR_OTHER|||||||0.499||||||A Bonferroni correction was used due to multiple comparisons. Comparisons are statistically significant if the two-sided p-value is ≤ 0.05/2=0.025.|Fisher Exact|||The null hypothesis is the incidence of malaria by placental impression smear is identical between subjects receiving maternal chloroquine IPT vs. maternal SP IPT.||||0.4990
72339871|NCT01443130|144203243|SUPERIORITY_OR_OTHER|||||||0.3089||||||A Bonferroni correction was used due to multiple comparisons. Comparisons are statistically significant if the two-sided p-value is ≤ 0.05/2=0.025.|Fisher Exact|||The null hypothesis is the incidence of maternal anemia is identical between subjects receiving maternal chloroquine prophylaxis vs. maternal SP IPT.||||0.3089
72339872|NCT01443130|144203243|SUPERIORITY_OR_OTHER|||||||0.6973||||||A Bonferroni correction was used due to multiple comparisons. Comparisons are statistically significant if the two-sided p-value is ≤ 0.05/2=0.025.|Fisher Exact|||The null hypothesis is the incidence of maternal anemia is identical between subjects receiving maternal chloroquine IPT vs. maternal SP IPT.||||0.6973
72339873|NCT01443130|144203244|SUPERIORITY_OR_OTHER|||||||1||||||A Bonferroni correction was used due to multiple comparisons. Comparisons are statistically significant if the two-sided p-value is ≤ 0.05/2=0.025.|Fisher Exact|||The null hypothesis is the incidence of maternal severe anemia is identical between subjects receiving maternal chloroquine prophylaxis vs. maternal SP IPT.||||1.00
72339874|NCT01443130|144203244|SUPERIORITY_OR_OTHER|||||||1||||||A Bonferroni correction was used due to multiple comparisons. Comparisons are statistically significant if the two-sided p-value is ≤ 0.05/2=0.025.|Fisher Exact|||The null hypothesis is the incidence of maternal severe anemia is identical between subjects receiving maternal chloroquine IPT vs. maternal SP IPT.||||1.00
72339875|NCT01443130|144203245|SUPERIORITY_OR_OTHER|||||||0.4979||||||A Bonferroni correction was used due to multiple comparisons. Comparisons are statistically significant if the two-sided p-value is ≤ 0.05/2=0.025.|Fisher Exact|||The null hypothesis is the incidence of stillbirth is identical between subjects receiving maternal chloroquine prophylaxis vs. maternal SP IPT.||||0.4979
72339876|NCT01443130|144203245|SUPERIORITY_OR_OTHER|||||||0.1166||||||A Bonferroni correction was used due to multiple comparisons. Comparisons are statistically significant if the two-sided p-value is ≤ 0.05/2=0.025.|Fisher Exact|||The null hypothesis is the incidence of stillbirth is identical between subjects receiving maternal chloroquine IPT vs. maternal SP IPT.||||0.1166
72339877|NCT01443130|144203246|SUPERIORITY_OR_OTHER|||||||0.6237||||||A Bonferroni correction was used due to multiple comparisons. Comparisons are statistically significant if the two-sided p-value is ≤ 0.05/2=0.025.|Fisher Exact|||The null hypothesis is the incidence of miscarriage is identical between subjects receiving maternal chloroquine prophylaxis vs. maternal SP IPT.||||0.6237
72339878|NCT01443130|144203246|SUPERIORITY_OR_OTHER|||||||1||||||A Bonferroni correction was used due to multiple comparisons. Comparisons are statistically significant if the two-sided p-value is ≤ 0.05/2=0.025.|Fisher Exact|||The null hypothesis is the incidence of miscarriage is identical between subjects receiving maternal chloroquine IPT vs. maternal SP IPT.||||1.000
72339879|NCT01443130|144203247|SUPERIORITY_OR_OTHER|||||||0.5187||||||A Bonferroni correction was used due to multiple comparisons. Comparisons are statistically significant if the two-sided p-value is ≤ 0.05/2=0.025.|Fisher Exact|||The null hypothesis is the incidence of preterm delivery is identical between subjects receiving maternal chloroquine prophylaxis vs. maternal SP IPT.||||0.5187
72339880|NCT01443130|144203247|SUPERIORITY_OR_OTHER|||||||0.2163||||||A Bonferroni correction was used due to multiple comparisons. Comparisons are statistically significant if the two-sided p-value is ≤ 0.05/2=0.025.|Fisher Exact|||The null hypothesis is the incidence of preterm delivery is identical between subjects receiving maternal chloroquine IPT vs. maternal SP IPT.||||0.2163
72339881|NCT01443130|144203248|SUPERIORITY_OR_OTHER|||||||0.5959||||||A Bonferroni correction was used due to multiple comparisons. Comparisons are statistically significant if the two-sided p-value is ≤ 0.05/2=0.025.|Fisher Exact|||The null hypothesis is the incidence of infant mortality within 14 weeks of delivery is identical between subjects receiving maternal chloroquine prophylaxis vs. maternal SP IPT.||||0.5959
72339882|NCT01443130|144203248|SUPERIORITY_OR_OTHER|||||||0.8127||||||A Bonferroni correction was used due to multiple comparisons. Comparisons are statistically significant if the two-sided p-value is ≤ 0.05/2=0.025.|Fisher Exact|||The null hypothesis is the incidence of infant mortality within 14 weeks of delivery is identical between subjects receiving maternal chloroquine IPT vs. maternal SP IPT.||||0.8127
72339883|NCT01443130|144203249|SUPERIORITY_OR_OTHER|||||||0.2566||||||A Bonferroni correction was used due to multiple comparisons. Comparisons are statistically significant if the two-sided p-value is ≤ 0.05/2=0.025.|Fisher Exact|||The null hypothesis is the incidence of low birth weight is identical between subjects receiving maternal chloroquine prophylaxis vs. maternal SP IPT.||||0.2566
72339884|NCT01443130|144203249|SUPERIORITY_OR_OTHER|||||||0.7839||||||A Bonferroni correction was used due to multiple comparisons. Comparisons are statistically significant if the two-sided p-value is ≤ 0.05/2=0.025.|Fisher Exact|||The null hypothesis is the incidence of low birth weight is identical between subjects receiving maternal chloroquine IPT vs. maternal SP IPT.||||0.7839
72339885|NCT01443130|144203250|SUPERIORITY_OR_OTHER|||||||0.2553||||||A Bonferroni correction was used due to multiple comparisons. Comparisons are statistically significant if the two-sided p-value is ≤ 0.05/2=0.025.|Fisher Exact|||The null hypothesis is the incidence of intrauterine growth restriction is identical between subjects receiving maternal chloroquine prophylaxis vs. maternal SP IPT.||||0.2553
72339886|NCT01443130|144203250|SUPERIORITY_OR_OTHER|||||||0.4354||||||A Bonferroni correction was used due to multiple comparisons. Comparisons are statistically significant if the two-sided p-value is ≤ 0.05/2=0.025.|Fisher Exact|||The null hypothesis is the incidence of intrauterine growth restriction is identical between subjects receiving maternal chloroquine IPT vs. maternal SP IPT.||||0.4354
72339887|NCT01443130|144203251|SUPERIORITY_OR_OTHER|||||||0.369||||||A Bonferroni correction was used due to multiple comparisons. Comparisons are statistically significant if the two-sided p-value is ≤ 0.05/2=0.025.|Fisher Exact|||The null hypothesis is the incidence of active placental malaria infection is identical between subjects receiving maternal chloroquine prophylaxis vs. maternal SP IPT.||||0.3690
72339888|NCT01443130|144203251|SUPERIORITY_OR_OTHER|||||||0.4947||||||A Bonferroni correction was used due to multiple comparisons. Comparisons are statistically significant if the two-sided p-value is ≤ 0.05/2=0.025.|Fisher Exact|||The null hypothesis is the incidence of active placental malaria infection is identical between subjects receiving maternal chloroquine IPT vs. maternal SP IPT.||||0.4947
72339889|NCT01443130|144203252|SUPERIORITY_OR_OTHER|||||||0.063||||||A Bonferroni correction was used due to multiple comparisons. Comparisons are statistically significant if the two-sided p-value is ≤ 0.05/2=0.025.|Fisher Exact|||The null hypothesis is the incidence of malaria infection (all species) measured by positive parasitemia is identical between subjects receiving maternal chloroquine prophylaxis vs. maternal SP IPT.||||0.0630
72339890|NCT01443130|144203252|SUPERIORITY_OR_OTHER|||||||0.4184||||||A Bonferroni correction was used due to multiple comparisons. Comparisons are statistically significant if the two-sided p-value is ≤ 0.05/2=0.025.|Fisher Exact|||The null hypothesis is the incidence of malaria infection (all species) measured by positive parasitemia is identical between subjects receiving maternal chloroquine IPT vs. maternal SP IPT.||||0.4184
72339891|NCT01443130|144203253|SUPERIORITY_OR_OTHER|||||||0.0268||||||A Bonferroni correction was used due to multiple comparisons. Comparisons are statistically significant if the two-sided p-value is ≤ 0.05/2=0.025.|Cox proportional hazards|||The null hypothesis is the incidence of clinical malaria (all species) is identical between subjects receiving maternal chloroquine prophylaxis vs. maternal SP IPT.||||0.0268
72339892|NCT01443130|144203253|SUPERIORITY_OR_OTHER|||||||0.1646||||||A Bonferroni correction was used due to multiple comparisons. Comparisons are statistically significant if the two-sided p-value is ≤ 0.05/2=0.025.|Cox proportional hazards|||The null hypothesis is the incidence of clinical malaria (all species) is identical between subjects receiving maternal chloroquine IPT vs. maternal SP IPT.||||0.1646
72339893|NCT01443130|144203254|SUPERIORITY_OR_OTHER|||||||0.4501||||||A Bonferroni correction was used due to multiple comparisons. Comparisons are statistically significant if the two-sided p-value is ≤ 0.05/2=0.025.|Fisher Exact|||The null hypothesis is the incidence of infection in the fetal circulation is identical between subjects receiving maternal chloroquine prophylaxis vs. maternal SP IPT.||||0.4501
72339894|NCT01443130|144203254|SUPERIORITY_OR_OTHER|||||||0.1758||||||A Bonferroni correction was used due to multiple comparisons. Comparisons are statistically significant if the two-sided p-value is ≤ 0.05/2=0.025.|Fisher Exact|||The null hypothesis is the incidence of infection in the fetal circulation is identical between subjects receiving maternal chloroquine IPT vs. maternal SP IPT.||||0.1758
72339895|NCT03461406|144203267|NON_INFERIORITY|The non-inferiority was deemed to have been demonstrated if the lower limit of the 95% confidence interval (CI) exceeds 0.8.|Relative risk|1.0|||<|0.001|TWO_SIDED|95.0|0.92|1.09|||Cochran-Mantel-Haenszel|||Hemostasis by 4 Minutes (Parenchymous)||1.09|0.92|< 0.001
72339896|NCT03461406|144203267|NON_INFERIORITY|The non-inferiority was deemed to have been demonstrated if the lower limit of the 95% CI exceeds 0.8|Relative risk|1.03|||<|0.001|TWO_SIDED|95.0|0.91|1.16|||Cochran-Mantel-Haenszel|||Hemostasis by 4 Minutes (Soft Tissue)||1.16|0.91|< 0.001
72339897|NCT03461406|144203268|NON_INFERIORITY|The non-inferiority was deemed to have been demonstrated if the lower limit of the 95% confidence interval (CI) exceeds 0.8.|Relative risk|1.0|||<|0.001|TWO_SIDED|95.0|0.92|1.09|||Cochran-Mantel-Haenszel|||Hemostasis by 7 Minutes (Parenchymous)||1.09|0.92|< 0.001
72339898|NCT03461406|144203268|NON_INFERIORITY|The non-inferiority was deemed to have been demonstrated if the lower limit of the 95% confidence interval (CI) exceeds 0.8.|Relative risk|1.0|||<|0.001|TWO_SIDED|95.0|0.92|1.09|||Cochran-Mantel-Haenszel|||Hemostasis by 7 Minutes (Soft tissue)||1.09|0.92|< 0.001
72339899|NCT03461406|144203269|NON_INFERIORITY|The non-inferiority was deemed to have been demonstrated if the lower limit of the 95% CI exceeds 0.8.|Relative risk|0.98|||<|0.001|TWO_SIDED|95.0|0.94|1.02|||Cochran-Mantel-Haenszel|||Hemostasis by 10 Minutes (Parenchymous)||1.02|0.94|< 0.001
72339900|NCT03461406|144203269|NON_INFERIORITY|The non-inferiority was deemed to have been demonstrated if the lower limit of the 95% CI exceeds 0.8.|Relative risk|1.0|||<|0.001|TWO_SIDED|95.0|0.92|1.09|||Cochran-Mantel-Haenszel|||Hemostasis by 10 Minutes (Soft tissue)||1.09|0.92|< 0.001
72339901|NCT00973102|144203277|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|2.47||||0.252|TWO_SIDED|95.0|1.16|5.25|||Barnard's unconditional Exact Test|||||5.25|1.16|.252
72339902|NCT00973102|144203278|SUPERIORITY_OR_OTHER_LEGACY|||||||0.895|||||||t-test, 2 sided|||||||.895
72339903|NCT00853840|144203279|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.11||||||90.0|-3.8|1.59|||Mixed Models Analysis|Sequence, period, time, treatment, \& time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.||"1.5 hour post-dose for supine systolic BP~Vardenafil minus Placebo~A total sample size of 18 subjects provides 90% confidence intervals for the difference between vardenafil and placebo of ±5.90 on the standing diastolic BP with 98% coverage probability at each time postdose."||1.59|-3.80|
72339904|NCT00853840|144203279|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.93||||||90.0|-3.55|-0.31|||Mixed Models Analysis|Sequence, period, time, treatment, \& time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.||"1.5 hour post-dose for supine diastolic BP~Vardenafil minus Placebo~A total sample size of 18 subjects provides 90% confidence intervals for the difference between vardenafil and placebo of ±5.90 on the standing diastolic BP with 98% coverage probability at each time postdose."||-0.31|-3.55|
72339905|NCT00853840|144203279|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.99||||||90.0|-7.69|-2.3|||Mixed Models Analysis|Sequence, period, time, treatment, \& time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.||"2 hour post-dose for supine systolic BP~Vardenafil minus Placebo~A total sample size of 18 subjects provides 90% confidence intervals for the difference between vardenafil and placebo of ±5.90 on the standing diastolic BP with 98% coverage probability at each time postdose."||-2.30|-7.69|
72339906|NCT00853840|144203279|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.96||||||90.0|-4.58|-1.34|||Mixed Models Analysis|Sequence, period, time, treatment, \& time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.||"2 hour post-dose for supine diastolic BP~Vardenafil minus Placebo~A total sample size of 18 subjects provides 90% confidence intervals for the difference between vardenafil and placebo of ±5.90 on the standing diastolic BP with 98% coverage probability at each time postdose."||-1.34|-4.58|
72339907|NCT00853840|144203279|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.88||||||90.0|-7.58|-2.19|||Mixed Models Analysis|Sequence, period, time, treatment, \& time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.||"2.5 hour post-dose for supine systolic BP~Vardenafil minus Placebo~A total sample size of 18 subjects provides 90% confidence intervals for the difference between vardenafil and placebo of ±5.90 on the standing diastolic BP with 98% coverage probability at each time postdose."||-2.19|-7.58|
72339908|NCT00853840|144203279|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.82||||||90.0|-5.44|-2.2|||Mixed Models Analysis|Sequence, period, time, treatment, \& time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.||"2.5 hour post-dose for supine diastolic BP~Vardenafil minus Placebo~A total sample size of 18 subjects provides 90% confidence intervals for the difference between vardenafil and placebo of ±5.90 on the standing diastolic BP with 98% coverage probability at each time postdose."||-2.20|-5.44|
72339909|NCT00853840|144203279|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.05||||||90.0|-4.74|0.64|||Mixed Models Analysis|Sequence, period, time, treatment, \& time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.||"3 hour post-dose for supine systolic BP~Vardenafil minus Placebo~A total sample size of 18 subjects provides 90% confidence intervals for the difference between vardenafil and placebo of ±5.90 on the standing diastolic BP with 98% coverage probability at each time postdose."||0.64|-4.74|
72339910|NCT00853840|144203279|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.76||||||90.0|-3.38|-0.15|||Mixed Models Analysis|Sequence, period, time, treatment, \& time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.||"3 hour post-dose for supine diastolic BP~Vardenafil minus Placebo~A total sample size of 18 subjects provides 90% confidence intervals for the difference between vardenafil and placebo of ±5.90 on the standing diastolic BP with 98% coverage probability at each time postdose."||-0.15|-3.38|
72339911|NCT00853840|144203279|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.08||||||90.0|-4.77|0.62|||Mixed Models Analysis|Sequence, period, time, treatment, \& time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.||"4 hour post-dose for supine systolic BP~Vardenafil minus Placebo~A total sample size of 18 subjects provides 90% confidence intervals for the difference between vardenafil and placebo of ±5.90 on the standing diastolic BP with 98% coverage probability at each time postdose."||0.62|-4.77|
72339912|NCT00853840|144203279|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.88||||||90.0|-2.49|0.74|||Mixed Models Analysis|Sequence, period, time, treatment, \& time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.||"4 hour post-dose for supine diastolic BP~Vardenafil minus Placebo~A total sample size of 18 subjects provides 90% confidence intervals for the difference between vardenafil and placebo of ±5.90 on the standing diastolic BP with 98% coverage probability at each time postdose."||0.74|-2.49|
72339913|NCT00853840|144203279|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.3||||||90.0|-4.99|0.39|||Mixed Models Analysis|Sequence, period, time, treatment, \& time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.||"6 hour post-dose for supine systolic BP~Vardenafil minus Placebo~A total sample size of 18 subjects provides 90% confidence intervals for the difference between vardenafil and placebo of ±5.90 on the standing diastolic BP with 98% coverage probability at each time postdose."||0.39|-4.99|
72339914|NCT00853840|144203279|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.85||||||90.0|-2.47|0.77|||Mixed Models Analysis|Sequence, period, time, treatment, \& time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.||"6 hour post-dose for supine diastolic BP~Vardenafil minus Placebo~A total sample size of 18 subjects provides 90% confidence intervals for the difference between vardenafil and placebo of ±5.90 on the standing diastolic BP with 98% coverage probability at each time postdose."||0.77|-2.47|
72339915|NCT00853840|144203279|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.22||||||90.0|-6.91|-1.52|||Mixed Models Analysis|Sequence, period, time, treatment, \& time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.||"8 hour post-dose for supine systolic BP~Vardenafil minus Placebo~A total sample size of 18 subjects provides 90% confidence intervals for the difference between vardenafil and placebo of ±5.90 on the standing diastolic BP with 98% coverage probability at each time postdose."||-1.52|-6.91|
72339916|NCT00853840|144203279|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.51||||||90.0|-4.13|-0.9|||Mixed Models Analysis|Sequence, period, time, treatment, \& time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.||"8 hour post-dose for supine diastolic BP~Vardenafil minus Placebo~A total sample size of 18 subjects provides 90% confidence intervals for the difference between vardenafil and placebo of ±5.90 on the standing diastolic BP with 98% coverage probability at each time postdose."||-0.90|-4.13|
72339917|NCT00853840|144203279|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.94||||||90.0|-4.63|0.76|||Mixed Models Analysis|Sequence, period, time, treatment, \& time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.||"12 hour post-dose for supine systolic BP~Vardenafil minus Placebo~A total sample size of 18 subjects provides 90% confidence intervals for the difference between vardenafil and placebo of ±5.90 on the standing diastolic BP with 98% coverage probability at each time postdose."||0.76|-4.63|
72339918|NCT00853840|144203279|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.32||||||90.0|-3.94|-0.7|||Mixed Models Analysis|Sequence, period, time, treatment, \& time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.||"12 hour post-dose for supine diastolic BP~Vardenafil minus Placebo~A total sample size of 18 subjects provides 90% confidence intervals for the difference between vardenafil and placebo of ±5.90 on the standing diastolic BP with 98% coverage probability at each time postdose."||-0.70|-3.94|
72428394|NCT01327547|144367748|SUPERIORITY_OR_OTHER||Difference in LS Mean|0.03||||0.8024|TWO_SIDED|95.0|-0.22|0.28|||ANCOVA||Difference in LS Mean|The above analysis is change for baseline in Log10 plasma HCV RNA at 48 Weeks. Results are from an ANCOVA model with change from baseline as the response variable and the following fixed effect model terms: treatment (Maraviroc or placebo), baseline value of the response variable, HBV, PI-based regimen.||0.28|-0.22|0.8024
72339919|NCT00853840|144203279|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.36||||||90.0|-8.22|-0.5|||Mixed Models Analysis|Sequence, period, time, treatment, \& time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.||"1.5 hour post-dose for standing systolic BP~Vardenafil minus Placebo~A total sample size of 18 subjects provides 90% confidence intervals for the difference between vardenafil and placebo of ±5.90 on the standing diastolic BP with 98% coverage probability at each time postdose."||-0.50|-8.22|
72339920|NCT00853840|144203279|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.93||||||90.0|-6.29|-1.56|||Mixed Models Analysis|Sequence, period, time, treatment, \& time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.||"1.5 hour post-dose for standing diastolic BP~Vardenafil minus Placebo~A total sample size of 18 subjects provides 90% confidence intervals for the difference between vardenafil and placebo of ±5.90 on the standing diastolic BP with 98% coverage probability at each time postdose."||-1.56|-6.29|
72339921|NCT00853840|144203279|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.91||||||90.0|-10.77|-3.05|||Mixed Models Analysis|Sequence, period, time, treatment, \& time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.||"2 hour post-dose for standing systolic BP~Vardenafil minus Placebo~A total sample size of 18 subjects provides 90% confidence intervals for the difference between vardenafil and placebo of ±5.90 on the standing diastolic BP with 98% coverage probability at each time postdose."||-3.05|-10.77|
72339922|NCT00853840|144203279|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.79||||||90.0|-8.15|-3.42|||Mixed Models Analysis|Sequence, period, time, treatment, \& time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.||"2 hour post-dose for standing diastolic BP~Vardenafil minus Placebo~A total sample size of 18 subjects provides 90% confidence intervals for the difference between vardenafil and placebo of ±5.90 on the standing diastolic BP with 98% coverage probability at each time postdose."||-3.42|-8.15|
72339923|NCT00853840|144203279|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.8||||||90.0|-9.66|-1.94|||Mixed Models Analysis|Sequence, period, time, treatment, \& time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.||"2.5 hour post-dose for standing systolic BP~Vardenafil minus Placebo~A total sample size of 18 subjects provides 90% confidence intervals for the difference between vardenafil and placebo of ±5.90 on the standing diastolic BP with 98% coverage probability at each time postdose."||-1.94|-9.66|
72339924|NCT00853840|144203279|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.65||||||90.0|-9.01|-4.29|||Mixed Models Analysis|Sequence, period, time, treatment, \& time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.||"2.5 hour post-dose for standing diastolic BP~Vardenafil minus Placebo~A total sample size of 18 subjects provides 90% confidence intervals for the difference between vardenafil and placebo of ±5.90 on the standing diastolic BP with 98% coverage probability at each time postdose."||-4.29|-9.01|
72339925|NCT00853840|144203279|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.27||||||90.0|-8.13|-0.41|||Mixed Models Analysis|Sequence, period, time, treatment, \& time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.||"3 hour post-dose for standing systolic BP~Vardenafil minus Placebo~A total sample size of 18 subjects provides 90% confidence intervals for the difference between vardenafil and placebo of ±5.90 on the standing diastolic BP with 98% coverage probability at each time postdose."||-0.41|-8.13|
72339926|NCT00853840|144203279|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.65||||||90.0|-6.01|-1.29|||Mixed Models Analysis|Sequence, period, time, treatment, \& time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.||"3 hour post-dose for standing diastolic BP~Vardenafil minus Placebo~A total sample size of 18 subjects provides 90% confidence intervals for the difference between vardenafil and placebo of ±5.90 on the standing diastolic BP with 98% coverage probability at each time postdose."||-1.29|-6.01|
72339927|NCT00853840|144203279|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.05||||||90.0|-5.91|1.81|||Mixed Models Analysis|Sequence, period, time, treatment, \& time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.||"4 hour post-dose for standing systolic BP~Vardenafil minus Placebo~A total sample size of 18 subjects provides 90% confidence intervals for the difference between vardenafil and placebo of ±5.90 on the standing diastolic BP with 98% coverage probability at each time postdose."||1.81|-5.91|
72339928|NCT00853840|144203279|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.09||||||90.0|-3.46|1.27|||Mixed Models Analysis|Sequence, period, time, treatment, \& time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.||"4 hour post-dose for standing diastolic BP~Vardenafil minus Placebo~A total sample size of 18 subjects provides 90% confidence intervals for the difference between vardenafil and placebo of ±5.90 on the standing diastolic BP with 98% coverage probability at each time postdose."||1.27|-3.46|
72339929|NCT00853840|144203279|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.3||||||90.0|-6.16|1.56|||Mixed Models Analysis|Sequence, period, time, treatment, \& time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.||"6 hour post-dose for standing systolic BP~Vardenafil minus Placebo~A total sample size of 18 subjects provides 90% confidence intervals for the difference between vardenafil and placebo of ±5.90 on the standing diastolic BP with 98% coverage probability at each time postdose."||1.56|-6.16|
72339930|NCT00853840|144203279|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.43||||||90.0|-5.79|-1.06|||Mixed Models Analysis|Sequence, period, time, treatment, \& time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.||"6 hour post-dose for standing diastolic BP~Vardenafil minus Placebo~A total sample size of 18 subjects provides 90% confidence intervals for the difference between vardenafil and placebo of ±5.90 on the standing diastolic BP with 98% coverage probability at each time postdose."||-1.06|-5.79|
72428395|NCT01327547|144367748|SUPERIORITY_OR_OTHER||Difference in LS Mean|0.15||||0.266|TWO_SIDED|95.0|-0.12|0.43|||ANCOVA||Difference in LS Mean|The above analysis is change for baseline in Log10 plasma HCV RNA at 96 Weeks. Results are from an ANCOVA model with change from baseline as the response variable and the following fixed effect model terms: treatment (Maraviroc or placebo), baseline value of the response variable, HBV, PI-based regimen.||0.43|-0.12|0.2660
72339931|NCT00853840|144203279|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.47||||||90.0|-7.33|0.39|||Mixed Models Analysis|Sequence, period, time, treatment, \& time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.||"8 hour post-dose for standing systolic BP~Vardenafil minus Placebo~A total sample size of 18 subjects provides 90% confidence intervals for the difference between vardenafil and placebo of ±5.90 on the standing diastolic BP with 98% coverage probability at each time postdose."||0.39|-7.33|
72339932|NCT00853840|144203279|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.26||||||90.0|-5.62|-0.9|||Mixed Models Analysis|Sequence, period, time, treatment, \& time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.||"8 hour post-dose for standing diastolic BP~Vardenafil minus Placebo~A total sample size of 18 subjects provides 90% confidence intervals for the difference between vardenafil and placebo of ±5.90 on the standing diastolic BP with 98% coverage probability at each time postdose."||-0.90|-5.62|
72339933|NCT00853840|144203279|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.27||||||90.0|-4.13|3.59|||Mixed Models Analysis|Sequence, period, time, treatment, \& time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.||"12 hour post-dose for standing systolic BP~Vardenafil minus Placebo~A total sample size of 18 subjects provides 90% confidence intervals for the difference between vardenafil and placebo of ±5.90 on the standing diastolic BP with 98% coverage probability at each time postdose."||3.59|-4.13|
72339934|NCT00853840|144203279|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.26||||||90.0|-4.62|0.1|||Mixed Models Analysis|Sequence, period, time, treatment, \& time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.||"12 hour post-dose for standing diastolic BP~Vardenafil minus Placebo~A total sample size of 18 subjects provides 90% confidence intervals for the difference between vardenafil and placebo of ±5.90 on the standing diastolic BP with 98% coverage probability at each time postdose."||0.10|-4.62|
72339935|NCT00853840|144203280|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.95||||||90.0|4.18|9.72|||Mixed Models Analysis|Sequence, period, time, treatment, \& time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.||"1.5 hour post-dose for supine pulse rate~Vardenafil minus Placebo"||9.72|4.18|
72339936|NCT00853840|144203280|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.51||||||90.0|2.73|8.28|||Mixed Models Analysis|Sequence, period, time, treatment, \& time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.||"2 hour post-dose for supine pulse rate~Vardenafil minus Placebo"||8.28|2.73|
72339937|NCT00853840|144203280|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.64||||||90.0|0.87|6.42|||Mixed Models Analysis|Sequence, period, time, treatment, \& time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.||"2.5 hour post-dose for supine pulse rate~Vardenafil minus Placebo"||6.42|0.87|
72339938|NCT00853840|144203280|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.89||||||90.0|0.12|5.67|||Mixed Models Analysis|Sequence, period, time, treatment, \& time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.||"3 hour post-dose for supine pulse rate~Vardenafil minus Placebo"||5.67|0.12|
72339939|NCT00853840|144203280|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.06||||||90.0|-0.71|4.83|||Mixed Models Analysis|Sequence, period, time, treatment, \& time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.||"4 hour post-dose for supine pulse rate~Vardenafil minus Placebo"||4.83|-0.71|
72339940|NCT00853840|144203280|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.45||||||90.0|2.68|8.22|||Mixed Models Analysis|Sequence, period, time, treatment, \& time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.||"6 hour post-dose for supine pulse rate~Vardenafil minus Placebo"||8.22|2.68|
72339941|NCT00853840|144203280|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.12||||||90.0|1.34|6.89|||Mixed Models Analysis|Sequence, period, time, treatment, \& time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.||"8 hour post-dose for supine pulse rate~Vardenafil minus Placebo"||6.89|1.34|
72339942|NCT00853840|144203280|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.45||||||90.0|0.68|6.22|||Mixed Models Analysis|Sequence, period, time, treatment, \& time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.||"12 hour post-dose for supine pulse rate~Vardenafil minus Placebo"||6.22|0.68|
72339943|NCT00853840|144203280|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.33||||||90.0|3.7|10.95|||Mixed Models Analysis|Sequence, period, time, treatment, \& time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.||"1.5 hour post-dose for standing pulse rate~Vardenafil minus Placebo"||10.95|3.70|
72339944|NCT00853840|144203280|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.83||||||90.0|3.2|10.45|||Mixed Models Analysis|Sequence, period, time, treatment, \& time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.||"2 hour post-dose for standing pulse rate~Vardenafil minus Placebo"||10.45|3.20|
72339945|NCT00853840|144203280|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.02||||||90.0|1.4|8.65|||Mixed Models Analysis|Sequence, period, time, treatment, \& time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.||"2.5 hour post-dose for standing pulse rate~Vardenafil minus Placebo"||8.65|1.40|
72339946|NCT00853840|144203280|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.72||||||90.0|1.09|8.34|||Mixed Models Analysis|Sequence, period, time, treatment, \& time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.||"3 hour post-dose for standing pulse rate~Vardenafil minus Placebo"||8.34|1.09|
72339947|NCT00853840|144203280|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.05||||||90.0|0.43|7.67|||Mixed Models Analysis|Sequence, period, time, treatment, \& time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.||"4 hour post-dose for standing pulse rate~Vardenafil minus Placebo"||7.67|0.43|
72339948|NCT00853840|144203280|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.36||||||90.0|2.73|9.98|||Mixed Models Analysis|Sequence, period, time, treatment, \& time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.||"6 hour post-dose for standing pulse rate~Vardenafil minus Placebo"||9.98|2.73|
72339949|NCT00853840|144203280|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.08||||||90.0|1.45|8.7|||Mixed Models Analysis|Sequence, period, time, treatment, \& time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.||"8 hour post-dose for standing pulse rate~Vardenafil minus Placebo"||8.70|1.45|
72339950|NCT00853840|144203280|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.88||||||90.0|-1.74|5.51|||Mixed Models Analysis|Sequence, period, time, treatment, \& time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.||"12 hour post-dose for standing pulse rate~Vardenafil minus Placebo"||5.51|-1.74|
72339951|NCT01710527|144203284|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence of Treatment T-Metformin 500 mg with Treatment R- Glucophage 500 mg was concluded if the 90% confidence intervals for the ratio of log transformed Cmax fell within the acceptance range of 80 to 125%.|Ratio (%)|96.85||||0.3125|TWO_SIDED|90.0|91.86|102.11|||ANOVA||Analysis was performed on log transformed geometric least square means.|||102.11|91.86|0.3125
72339952|NCT01710527|144203285|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence of Treatment T-Metformin 500 mg with Treatment R- Glucophage 500 mg was concluded if the 90% confidence intervals for the ratio of log transformed AUC0-t fell within the acceptance range of 80 to 125%.|Ratio (%)|102.52||||0.2701|TWO_SIDED|90.0|98.74|106.45|||ANOVA|||Comparison of Treatment T-Metformin 500 mg and Treatment R- Glucophage 500 mg for AUC0-t||106.45|98.74|0.2701
72339953|NCT01710527|144203285|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence of Treatment T-Metformin 500 mg with Treatment R- Glucophage 500 mg was concluded if the 90% confidence intervals for the ratio of log transformed AUC0-infinity fell within the acceptance range of 80 to 125%.|Ratio (%)|102.44||||0.2702|TWO_SIDED|90.0|98.78|106.23|||ANOVA||Analysis was performed on log transformed geometric least square means.|Comparison of Treatment T-Metformin 500 mg and Treatment R- Glucophage 500 mg for AUC0-infinity.||106.23|98.78|0.2702
72339954|NCT02358044|144203349|NON_INFERIORITY_OR_EQUIVALENCE|The lower bound of 95% CIs was compared to pre-specified non-inferiority margin, -10% to evaluate non-inferiority. The Missing=Failure (M=F) approach was used to handle missing values.|Adjusted Difference in Percentage|8.8|||<|0.001|TWO_SIDED|95.0|3.6|15.3|||Miettinen & Nurminen Method|||"Primary Analysis Approach: Non-Inferiority~Analyses of the percentage of participants achieving SVR12 was conducted using the Miettinen \& Nurminen (M\&N) method. The analysis was adjusted for genotype (1a vs. non-1a) and fibrosis stage (cirrhotic vs. non-cirrhotic). The adjusted differences (grazoprevir+elbasvir arm minus SOF+PR arm) in percentages along with the corresponding 95% confidence intervals (CIs) and p-values were provided."||15.3|3.6|<0.001
72339955|NCT02358044|144203349|SUPERIORITY_OR_OTHER||Adjusted Difference in Percentage|8.8||||0.001|TWO_SIDED|95.0|3.6|15.3|||Miettinen & Nurminen Method|The lower bound of 95% CIs was compared to zero to evaluate superiority. The M=F approach was used to handle missing values.||"Secondary Analysis Approach: Superiority~Analyses of the percentage of participants achieving SVR12 was conducted using the M\&N method. The analysis was adjusted for genotype (1a vs. non-1a) and fibrosis stage (cirrhotic vs. non-cirrhotic). The adjusted differences (grazoprevir +elbasvir arm minus SOF+PR arm) in percentages along with the corresponding 95% CIs and p-values were provided."||15.3|3.6|0.001
72339956|NCT02358044|144203350|SUPERIORITY_OR_OTHER||Difference in Percentage|-41.7|||||TWO_SIDED|95.0|-51.1|-31.9||||||The percentage of participants with an event were assessed via point estimates with 95% CIs provided for between-group comparisons.||-31.9|-51.1|
72339957|NCT02358044|144203352|SUPERIORITY_OR_OTHER||Difference in Percentage|-27.0|||<|0.001|TWO_SIDED|95.0|-35.5|-19.6||% of participants with ≥1 Tier 1 event = total number participants with ≥1 Tier 1 event ÷ total number ASaT participants within each treatment arm. M\&N method used to calculate a 2-sided 95% CI for the treatment difference and corresponding p-value.|Miettinen & Nurminen Method|||"Total Tier 1 AEs:~If, and only if the primary efficacy null hypothesis was rejected, the Tier 1 safety superiority hypothesis was tested at the 2-sided 5% alpha level. The safety superiority hypothesis was that the percentage of grazoprevir+elbasvir participants with ≥1 Tier 1 event is lower than the percentage of SOF+PR participants with ≥1 Tier 1 event."||-19.6|-35.5|<0.001
72339958|NCT02358044|144203352|SUPERIORITY_OR_OTHER||Difference in Percentage|-2.4||||0.078|TWO_SIDED|95.0|-6.8|0.6||% of participants with ≥1 Tier 1 event = total number participants with ≥1 Tier 1 event ÷ total number ASaT participants within each treatment arm. M\&N method used to calculate a 2-sided 95% CI for the treatment difference and corresponding p-value.|Miettinen & Nurminen Method|||"Serious drug-related AEs:~If, and only if the primary efficacy null hypothesis was rejected, the Tier 1 safety superiority hypothesis was tested at the 2-sided 5% alpha level. The safety superiority hypothesis was that the percentage of grazoprevir+elbasvir participants with ≥1 Tier 1 event is lower than the percentage of SOF+PR participants with ≥1 Tier 1 event."||0.6|-6.8|0.078
72339959|NCT02358044|144203352|SUPERIORITY_OR_OTHER||Difference in Percentage|-0.8||||0.312|TWO_SIDED|95.0|-4.4|2.1||% of participants with ≥1 Tier 1 event = total number participants with ≥1 Tier 1 event ÷ total number ASaT participants within each treatment arm. M\&N method used to calculate a 2-sided 95% CI for the treatment difference and corresponding p-value.|Miettinen & Nurminen Method|||"DC due to drug-related AE:~If, and only if the primary efficacy null hypothesis was rejected, the Tier 1 safety superiority hypothesis was tested at the 2-sided 5% alpha level. The safety superiority hypothesis was that the percentage of grazoprevir+elbasvir participants with ≥1 Tier 1 event is lower than the percentage of SOF+PR participants with ≥1 Tier 1 event."||2.1|-4.4|0.312
72339960|NCT02358044|144203352|SUPERIORITY_OR_OTHER||Difference in Percentage|-12.7|||<|0.001|TWO_SIDED|95.0|-19.7|-8.0||% of participants with ≥1 Tier 1 event = total number participants with ≥1 Tier 1 event ÷ total number ASaT participants within each treatment arm. M\&N method used to calculate a 2-sided 95% CI for the treatment difference and corresponding p-value.|Miettinen & Nurminen Method|||"Neutrophil count \<0.75 x 10\^9/L:~If, and only if the primary efficacy null hypothesis was rejected, the Tier 1 safety superiority hypothesis was tested at the 2-sided 5% alpha level. The safety superiority hypothesis was that the percentage of grazoprevir+elbasvir participants with ≥1 Tier 1 event is lower than the percentage of SOF+PR participants with ≥1 Tier 1 event."||-8.0|-19.7|<0.001
72370015|NCT05367492|144250430|SUPERIORITY||Mean Difference (Net)|-1.78||||0.008|TWO_SIDED|95.0|-3.08|-0.48||Benjamini-Hochberg multiplicity correction applied to p-values reported across family of three secondary analysis results (Varenicline vs Placebo comparisons of secondary inventory outcomes).|Regression, Linear|Models fit to data from varenicline and placebo groups only using GEE, adjusted for sex, baseline ECDI and outcome score, and quadratic trend of time.|Adjusted mean difference comparing varenicline versus placebo. Negative indicates larger mean in placebo.|||-0.48|-3.08|0.008
72339961|NCT02358044|144203352|SUPERIORITY_OR_OTHER||Difference in Percentage|-13.5|||<|0.001|TWO_SIDED|95.0|-20.8|-7.9||% of participants with ≥1 Tier 1 event = total number participants with ≥1 Tier 1 event ÷ total number ASaT participants within each treatment arm. M\&N method used to calculate a 2-sided 95% CI for the treatment difference and corresponding p-value.|Miettinen & Nurminen Method|||"Hemoglobin \<10 g/dL:~If, and only if the primary efficacy null hypothesis was rejected, the Tier 1 safety superiority hypothesis was tested at the 2-sided 5% alpha level. The safety superiority hypothesis was that the percentage of grazoprevir+elbasvir participants with ≥1 Tier 1 event is lower than the percentage of SOF+PR participants with ≥1 Tier 1 event."||-7.9|-20.8|<0.001
72339962|NCT02358044|144203353|NON_INFERIORITY_OR_EQUIVALENCE|The lower bound of 95% CIs was compared to pre-specified non-inferiority margin, -10% to evaluate non-inferiority. The Missing=Failure (M=F) approach was used to handle missing values.|Adjusted Difference in Percentage|8.8|||||TWO_SIDED|95.0|3.3|15.7||||||Analyses of the percentage of participants achieving SVR24 was conducted using the Miettinen \& Nurminen (M\&N) method. The analysis was adjusted for genotype (1a vs. non-1a) and fibrosis stage (cirrhotic vs. non-cirrhotic). The adjusted differences (grazoprevir+elbasvir arm minus SOF+PR arm) in percentages along with the corresponding 95% confidence intervals (CIs) and p-values were provided.||15.7|3.3|
72339963|NCT01739803|144203355|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0||||To control for experiment-wise Type I error rate in this analysis, a comparison-wise alpha of 0.01 was used.|Mixed Models Analysis|||We projected mean composite adherence rate for all participants to be approximately 80% ± 15. We anticipated at least 10% increase in intervention group adherence at end of intervention. To have 80% power to detect expected difference of 10% at the 2-tailed 5% significance level, sample size needed to be at least 36 RTRs per group. We took a conservative approach, in combination with anticipated attrition over the course of study, and increased enrollment.||||<0.05
72339964|NCT01739803|144203356|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANOVA|||||||0.05
72339965|NCT01739803|144203357|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.05||||0.05|TWO_SIDED|95.0|||||Chi-squared|||||||0.05
72339966|NCT01428336|144203358|NON_INFERIORITY|A non-inferiority region of 0.15 for the difference in correlations is expected.|Difference in correlation|0.06|||||TWO_SIDED|95.0|-0.2|0.6||||||Analysis comparing Peak 25ug CST correlation with ITT vs. Peak 1ug CST correlation with ITT||0.60|-0.20|
72339967|NCT01428336|144203358|NON_INFERIORITY|A non-inferiority region of 0.15 for the difference in correlations is expected.|Difference in correlation|-0.07|||||TWO_SIDED|95.0|-0.69|-0.01||||||Analysis comparing Peak 25ug CST correlation with ITT vs. Peak 250ug CST correlation with ITT||-0.01|-0.69|
72339968|NCT01428336|144203358|NON_INFERIORITY|A non-inferiority region of 0.15 for the difference in correlations is expected.|Difference in correlation|-0.06|||||TWO_SIDED|95.0|-0.65|0.04||||||Analysis comparing Peak 25ug CST correlation with ITT vs. 30-minute 250ug CST correlation with ITT||0.04|-0.65|
72339969|NCT01428336|144203359|NON_INFERIORITY|A non-inferiority region of 0.15 for the difference in correlations is expected.|Difference in correlation|0.12|||||TWO_SIDED|95.0|-0.24|0.65||||||Analysis comparing Peak 25ug CST correlation with ITT vs. Peak 1ug CST correlation with ITT - free cortisol||0.65|-0.24|
72339970|NCT01428336|144203359|NON_INFERIORITY|A non-inferiority region of 0.15 for the difference in correlations is expected.|Difference in correlation|-0.18|||||TWO_SIDED|95.0|-0.91|-0.15||||||Analysis comparing Peak 25ug CST correlation with ITT vs. Peak 250ug CST correlation with ITT - free cortisol||-0.15|-0.91|
72339971|NCT01428336|144203359|NON_INFERIORITY|A non-inferiority region of 0.15 for the difference in correlations is expected.|Difference in correlation|-0.19|||||TWO_SIDED|95.0|-0.94|-0.14||||||Analysis comparing Peak 25ug CST correlation with ITT vs. 30-minute 250ug CST correlation with ITT - free cortisol||-0.14|-0.94|
72339972|NCT02525094|144203370|SUPERIORITY||Odds Ratio (OR)|1.97|||||TWO_SIDED|95.0|0.9|4.33||||||||4.33|0.90|
72339973|NCT01751776|144203384|SUPERIORITY_OR_OTHER_LEGACY||Slope|2.0506|STANDARD_ERROR_OF_MEAN|0.4242|||TWO_SIDED|95.0|1.1843|2.9168|||||Dose proportionality was explored using a regression model. Based on the estimate for the slope parameter, a 2-sided 95% CI was computed. Perfect dose proportionality would correspond to a slope of 1. PK endpoints on the log-transformed scale.|Dose proportionality for Cmax was explored after the first adminstration of BI 65564 on Day 1.||2.9168|1.1843|
72339974|NCT01751776|144203384|SUPERIORITY_OR_OTHER_LEGACY||Slope|1.4227|STANDARD_ERROR_OF_MEAN|0.1644|||TWO_SIDED|95.0|1.0869|1.7584|||||Dose proportionality was explored using a regression model. Based on the estimate for the slope parameter, a 2-sided 95% CI was computed. Perfect dose proportionality would correspond to a slope of 1. PK endpoints on the log-transformed scale.|Dose proportionality for Cmax was explored after the last (fourth) adminstration of BI 65564 on Day 22.||1.7584|1.0869|
72339975|NCT01751776|144203385|SUPERIORITY_OR_OTHER_LEGACY||Slope|2.0091|STANDARD_ERROR_OF_MEAN|0.1706|||TWO_SIDED|95.0|1.6607|2.3575|||||Dose proportionality was explored using a regression model. Based on the estimate for the slope parameter, a 2-sided 95% CI was computed. Perfect dose proportionality would correspond to a slope of 1. PK endpoints on the log-transformed scale.|Dose proportionality for AUC 0-infinity was explored after the last adminstration of BI 65564 on Day 22.||2.3575|1.6607|
72339976|NCT01751776|144203386|SUPERIORITY_OR_OTHER_LEGACY||Slope|1.4225|STANDARD_ERROR_OF_MEAN|0.164|||TWO_SIDED|95.0|1.0876|1.7574|||||Dose proportionality was explored using a regression model. Based on the estimate for the slope parameter, a 2-sided 95% CI was computed. Perfect dose proportionality would correspond to a slope of 1. PK endpoints on the log-transformed scale.|Dose proportionality for AUCtau was explored after the last administration of BI 65564 on Day 22.||1.7574|1.0876|
72339977|NCT01751776|144203388|OTHER||Mean Difference (Net)|22.7|||||||||||||Mean Difference in percentage|Observed difference of ACR20 response for BI 120mg - Placebo||||
72339978|NCT01751776|144203388|OTHER|Evaluation of the difference in ACR20 response rates using a Bayesian approach. Results based on 1000000 simulations of the posterior distribution; for the treatment group a non-informative beta (0,0) prior was used; for the placebo group, an informative beta (5.5, 16.5) prior was used; prior to any imputation, assessments up to the End of Trial (EoT) visit were mapped to an on-treatment visit window (Visit 4/Week 2 - Visit 14 (EoT)/Week 12) relative to the day of the first dose.|Mean Difference (Net)|33.0|||||||||||||Mean Difference in percentage|Expected difference of ACR20 response for BI 120mg - Placebo||||
72370016|NCT05367492|144250430|SUPERIORITY|||||||0.02||||||Benjamini-Hochberg multiplicity correction applied to p-values reported across family of three secondary analysis results (Omnibus Wald test of secondary inventory outcomes).|Regression, Linear|Models fit using GEE, adjusted for sex, baseline ECDI and outcome score, and quadratic time. Omnibus Wald test of any difference across study groups.||||||0.02
72370017|NCT05367492|144250431|SUPERIORITY|||||||0.16|||||||Fisher Exact|||||||0.16
72339979|NCT01751776|144203388|OTHER|Evaluation of the difference in ACR20 response rates using a Bayesian approach. Results based on 1000000 simulations of the posterior distribution; for the treatment group a non-informative beta (0,0) prior was used; for the placebo group, an informative beta (5.5, 16.5) prior was used; prior to any imputation, assessments up to the End of Trial (EoT) visit were mapped to an on-treatment visit window (Visit 4/Week 2 - Visit 14 (EoT)/Week 12) relative to the day of the first dose.|Probability in percentage|99.9||||||||||||||Probability that difference of ACR20 response for BI 120mg - Placebo is larger than 0%||||
72339980|NCT01751776|144203388|OTHER|Evaluation of the difference in ACR20 response rates using a Bayesian approach. Results based on 1000000 simulations of the posterior distribution; for the treatment group a non-informative beta (0,0) prior was used; for the placebo group, an informative beta (5.5, 16.5) prior was used; prior to any imputation, assessments up to the End of Trial (EoT) visit were mapped to an on-treatment visit window (Visit 4/Week 2 - Visit 14 (EoT)/Week 12) relative to the day of the first dose.|Probability in percentage|99.7||||||||||||||Probability that difference of ACR20 response for BI 120mg - Placebo is larger than 5%||||
72339981|NCT01751776|144203388|OTHER|Evaluation of the difference in ACR20 response rates using a Bayesian approach. Results based on 1000000 simulations of the posterior distribution; for the treatment group a non-informative beta (0,0) prior was used; for the placebo group, an informative beta (5.5, 16.5) prior was used; prior to any imputation, assessments up to the End of Trial (EoT) visit were mapped to an on-treatment visit window (Visit 4/Week 2 - Visit 14 (EoT)/Week 12) relative to the day of the first dose.|Probability in percentage|98.7||||||||||||||Probability that difference of ACR20 response for BI 120mg - Placebo is larger than 10%||||
72339982|NCT01751776|144203388|OTHER|Evaluation of the difference in ACR20 response rates using a Bayesian approach. Results based on 1000000 simulations of the posterior distribution; for the treatment group a non-informative beta (0,0) prior was used; for the placebo group, an informative beta (5.5, 16.5) prior was used; prior to any imputation, assessments up to the End of Trial (EoT) visit were mapped to an on-treatment visit window (Visit 4/Week 2 - Visit 14 (EoT)/Week 12) relative to the day of the first dose.|Probability in percentage|96.0||||||||||||||Probability that difference of ACR20 response for BI 120mg - Placebo is larger than 15%||||
72339983|NCT01751776|144203388|OTHER|Evaluation of the difference in ACR20 response rates using a Bayesian approach. Results based on 1000000 simulations of the posterior distribution; for the treatment group a non-informative beta (0,0) prior was used; for the placebo group, an informative beta (5.5, 16.5) prior was used; prior to any imputation, assessments up to the End of Trial (EoT) visit were mapped to an on-treatment visit window (Visit 4/Week 2 - Visit 14 (EoT)/Week 12) relative to the day of the first dose.|Probability in percentage|90.0||||||||||||||Probability that difference of ACR20 response for BI 120mg - Placebo is larger than 20%||||
72339984|NCT01751776|144203388|OTHER|Evaluation of the difference in ACR20 response rates using a Bayesian approach. Results based on 1000000 simulations of the posterior distribution; for the treatment group a non-informative beta (0,0) prior was used; for the placebo group, an informative beta (5.5, 16.5) prior was used; prior to any imputation, assessments up to the End of Trial (EoT) visit were mapped to an on-treatment visit window (Visit 4/Week 2 - Visit 14 (EoT)/Week 12) relative to the day of the first dose.|Probability in percentage|79.0||||||||||||||Probability that difference of ACR20 response for BI 120mg - Placebo is larger than 25%||||
72339985|NCT01751776|144203388|OTHER|Evaluation of the difference in ACR20 response rates using a Bayesian approach. Results based on 1000000 simulations of the posterior distribution; for the treatment group a non-informative beta (0,0) prior was used; for the placebo group, an informative beta (5.5, 16.5) prior was used; prior to any imputation, assessments up to the End of Trial (EoT) visit were mapped to an on-treatment visit window (Visit 4/Week 2 - Visit 14 (EoT)/Week 12) relative to the day of the first dose.|Probability in percentage|62.5||||||||||||||Probability that difference of ACR20 response for BI 120mg - Placebo is larger than 30%||||
72339986|NCT01751776|144203388|OTHER|Evaluation of the difference in ACR20 response rates using a Bayesian approach. Results based on 1000000 simulations of the posterior distribution; for the treatment group a non-informative beta (0,0) prior was used; for the placebo group, an informative beta (5.5, 16.5) prior was used; prior to any imputation, assessments up to the End of Trial (EoT) visit were mapped to an on-treatment visit window (Visit 4/Week 2 - Visit 14 (EoT)/Week 12) relative to the day of the first dose.|Probability in percentage|42.9||||||||||||||Probability that difference of ACR20 response for BI 120mg - Placebo is larger than 35%||||
72339987|NCT01751776|144203388|OTHER|Evaluation of the difference in ACR20 response rates using a Bayesian approach. Results based on 1000000 simulations of the posterior distribution; for the treatment group a non-informative beta (0,0) prior was used; for the placebo group, an informative beta (5.5, 16.5) prior was used; prior to any imputation, assessments up to the End of Trial (EoT) visit were mapped to an on-treatment visit window (Visit 4/Week 2 - Visit 14 (EoT)/Week 12) relative to the day of the first dose.|Probability in percentage|24.5||||||||||||||Probability that difference of ACR20 response for BI 120mg - Placebo is larger than 40%||||
72339988|NCT01751776|144203388|OTHER|Evaluation of the difference in ACR20 response rates using a Bayesian approach. Results based on 1000000 simulations of the posterior distribution; for the treatment group a non-informative beta (0,0) prior was used; for the placebo group, an informative beta (5.5, 16.5) prior was used; prior to any imputation, assessments up to the End of Trial (EoT) visit were mapped to an on-treatment visit window (Visit 4/Week 2 - Visit 14 (EoT)/Week 12) relative to the day of the first dose.|Probability in percentage|11.1||||||||||||||Probability that difference of ACR20 response for BI 120mg - Placebo is larger than 45%||||
72339989|NCT01751776|144203389|SUPERIORITY_OR_OTHER_LEGACY||Risk difference, unadjusted|18.2||||0.0754|TWO_SIDED|95.0|-6.6|38.6|||One-sided exact test (see description)|One-sided exact test for superiority testing|The exact 95% confidence interval was calculated by Clopper and Pearson.|unadjusted||38.6|-6.6|0.0754
72339990|NCT01751776|144203389|SUPERIORITY_OR_OTHER_LEGACY||risk difference, adjusted|20.0|||||TWO_SIDED|95.0|-4.6|39.0|||||The 95 % confidence interval was determined by root method to determine the cumulative distribution function. Adjusted for treatment, region and anti-Tumour Necrosis Factor (TNF)|adjusted||39.0|-4.6|
72339991|NCT01751776|144203390|SUPERIORITY_OR_OTHER_LEGACY||risk difference, unadjusted|4.5||||0.3938|TWO_SIDED|95.0|-18.4|22.3|||one-sided exact test (see description)|one-sided exact test for superiority testing.|The exact 95% confidence interval was calculated by Clopper and Pearson.|unadjusted||22.3|-18.4|0.3938
72339992|NCT01751776|144203390|SUPERIORITY_OR_OTHER_LEGACY||risk difference, adjusted|4.0|||||TWO_SIDED|95.0|-18.9|21.1|||||The 95 % confidence interval was determined by root method to determine the cumulative distribution function. Adjusted for treatment, region and anti-TNF history|adjusted||21.1|-18.9|
72339993|NCT01751776|144203393|SUPERIORITY_OR_OTHER_LEGACY||Risk difference|6.8|||||TWO_SIDED|95.0|-17.6|32.7|||||The exact 95% confidence interval was calculated by Clopper and Pearson.|unadjusted||32.7|-17.6|
72339994|NCT01751776|144203393|SUPERIORITY_OR_OTHER_LEGACY||risk difference, adjusted|8.9|||||TWO_SIDED|95.0|-15.9|34.2|||||The 95 % confidence interval was determined by root method to determine the cumulative distribution function. Adjusted for treatment, region and anti-TNF history|adjusted||34.2|-15.9|
72339995|NCT01751776|144203394|SUPERIORITY_OR_OTHER_LEGACY||Adjusted mean|-0.14|STANDARD_ERROR_OF_MEAN|0.266|||TWO_SIDED|95.0|-0.67|0.39|||||difference calculated as BI 655064 120mg minus placebo. The ANCOVA model was used. In this model the mean was adjusted for region, anti-TNF history and baseline DAS28-CRP.|difference calculated as BI 655064 120mg minus placebo.||0.39|-0.67|
72339996|NCT01122108|144203395|SUPERIORITY_OR_OTHER||||||<|0.05||||||If a sequence was not found to be statistically significant, then that term was removed from final model. Normality of residuals was investigated for each outcome variable using the Shapiro-Wilk test.|repeated measures analysis of variance|Sensitivity analyses were run to evaluate possible product by sequence interactions||"The BASA scale was previously developed to effectively compare differing Bile acid sequestrant forumulations. The BASA scale should differentiate subject acceptability of Colesevelam HCl 3.75 vs Cholestyramine 12g based upon the sum of ratings for taste, texture, appearance and mixability.~If normality hypothesis was rejected, then further inspection of the distribution utilizing normal quantile-quantile and kernel density plots was employed."||||<0.05
72339997|NCT01831817|144203403|SUPERIORITY_OR_OTHER||Mean change difference|-0.1||||0.4321|TWO_SIDED|95.0|-0.35|0.15|||ANCOVA||Treatment as fixed factor and baseline Schiff score as covariate. Difference was First named treatment-second named treatment that a negative difference implied the mean of the second named treatment was larger than that of the first named treatment|Principal null hypothesis to be tested was- H0: The change from baseline was the same for both treatments in all pairwise comparisons||0.15|-0.35|0.4321
72339998|NCT01831817|144203403|SUPERIORITY_OR_OTHER||Mean change difference|-0.48||||0.0002|TWO_SIDED|95.0|-0.73|-0.23|||ANCOVA||Treatment as fixed factor and baseline Schiff score as covariate. Difference is First named treatment - second named treatment that a negative difference implies the mean of the second named treatment is larger than that of the first named treatment|Principal null hypothesis to be tested was- H0: The change from baseline was the same for both treatments in all pairwise comparisons||-0.23|-0.73|0.0002
72339999|NCT01831817|144203403|SUPERIORITY_OR_OTHER||Mean change difference|-0.49||||0.0002|TWO_SIDED|95.0|-0.74|-0.24|||ANCOVA||Treatment as fixed factor and baseline Schiff score as covariate. Difference is First named treatment - second named treatment that a negative difference implies the mean of the second named treatment is larger than that of the first named treatment|Principal null hypothesis to be tested was- H0: The change from baseline was the same for both treatments in all pairwise comparisons||-0.24|-0.74|0.0002
72340000|NCT01831817|144203403|SUPERIORITY_OR_OTHER||Mean change difference|0.38||||0.0028|TWO_SIDED|95.0|0.13|0.63|||ANCOVA||Treatment as fixed factor and baseline Schiff score as covariate. Difference is second named treatment - first named treatment that a negative difference implies the mean of the first named treatment is larger than that of the second named treatment|Principal null hypothesis to be tested was- H0: The change from baseline was the same for both treatments in all pairwise comparisons||0.63|0.13|0.0028
72340001|NCT01831817|144203403|SUPERIORITY_OR_OTHER||Mean change difference|0.39||||0.0022|TWO_SIDED|95.0|0.14|0.63|||ANCOVA||Treatment as fixed factor and baseline Schiff score as covariate. Difference is Second named treatment - first named treatment that a negative difference implies the mean of the first named treatment is larger than that of the second named treatment|Principal null hypothesis to be tested was- H0: The change from baseline waas the same for both treatments in all pairwise comparisons||0.63|0.14|0.0022
72340002|NCT01831817|144203403|SUPERIORITY_OR_OTHER||Mean change difference|-0.01||||0.9606|TWO_SIDED|95.0|-0.25|0.24|||ANCOVA||Treatment as fixed factor and baseline Schiff score as covariate. Difference is Second named treatment - first named treatment that a negative difference implies the mean of the first named treatment is larger than that of the second named treatment|Principal null hypothesis to be tested was- H0: The change from baseline was the same for both treatments in all pairwise comparisons||0.24|-0.25|0.9606
72340003|NCT01831817|144203404|SUPERIORITY_OR_OTHER||Mean change difference|0.04||||0.803|TWO_SIDED|95.0|-0.3|0.38|||ANCOVA||Treatment as fixed factor and baseline Schiff score as covariate. Difference is First named treatment - second named treatment that a negative difference implies the mean of the second named treatment is larger than that of the first named treatment|Principal null hypothesis to be tested was- H0: The change from baseline was the same for both treatments in all pairwise comparisons||0.38|-0.30|0.8030
72340004|NCT01831817|144203404|SUPERIORITY_OR_OTHER||Mean change difference|-0.82|||<|0.0001|TWO_SIDED|95.0|-1.16|-0.48|||ANCOVA||Treatment as fixed factor and baseline Schiff score as covariate. Difference is First named treatment - second named treatment that a negative difference implies the mean of the second named treatment is larger than that of the first named treatment|Principal null hypothesis to be tested was- H0: The change from baseline was the same for both treatments in all pairwise comparisons||-0.48|-1.16|<0.0001
72340005|NCT01831817|144203404|SUPERIORITY_OR_OTHER||Mean change difference|-0.86|||<|0.0001|TWO_SIDED|95.0|-1.2|-0.53|||ANCOVA||Treatment as fixed factor and baseline Schiff score as covariate. Difference is First named treatment - second named treatment that a negative difference implies the mean of the second named treatment is larger than that of the first named treatment|Principal null hypothesis to be tested was- H0: The change from baseline was the same for both treatments in all pairwise comparisons||-0.53|-1.20|<0.0001
72340006|NCT01831817|144203404|SUPERIORITY_OR_OTHER||Mean change difference|0.86|||<|0.0001|TWO_SIDED|95.0|0.53|1.19|||ANCOVA||Treatment as fixed factor and baseline Schiff score as covariate. Difference is Second named treatment - first named treatment that a negative difference implies the mean of the first named treatment is larger than that of the second named treatment|Principal null hypothesis to be tested was- H0: The change from baseline was the same for both treatments in all pairwise comparisons||1.19|0.53|<0.0001
72370018|NCT05367492|144250431|SUPERIORITY|||||||0.083|||||||Fisher Exact|||||||0.083
72370019|NCT00856518|144250525|SUPERIORITY_OR_OTHER|||||||0.899||||||EMST arm vs. Sham arm baseline MEP value comparison|Wilcoxon (Mann-Whitney)|||||||0.899
72340007|NCT01831817|144203404|SUPERIORITY_OR_OTHER||Mean change difference|0.91|||<|0.0001|TWO_SIDED|95.0|0.58|1.23|||ANCOVA||Treatment as fixed factor and baseline Schiff score as covariate. Difference is Second named treatment - first named treatment that a negative difference implies the mean of the second named treatment is larger than that of the first named treatment|Principal null hypothesis to be tested was- H0: The change from baseline was the same for both treatments in all pairwise comparisons||1.23|0.58|<0.0001
72340008|NCT01831817|144203404|SUPERIORITY_OR_OTHER||Mean change difference|-0.04||||0.7872|TWO_SIDED|95.0|-0.37|0.28|||ANCOVA||Treatment as fixed factor and baseline Schiff score as covariate. Difference is Second named treatment - first named treatment that a negative difference implies the mean of the first named treatment is larger than that of the second named treatment|Principal null hypothesis to be tested was- H0: The change from baseline was the same for both treatments in all pairwise comparisons||0.28|-0.37|0.7872
72340009|NCT01831817|144203405|SUPERIORITY_OR_OTHER||Hodges-Lehmann shift|0.0||||0.9642|TWO_SIDED|95.0|0.0|0.0|||Hodges-Lehmann Wilcoxon non-parametric||Positive values favour the first named treatment|||0.00|0.00|0.9642
72340010|NCT01831817|144203405|SUPERIORITY_OR_OTHER||Hodges-Lehmann shift|0.0||||0.0016|TWO_SIDED|95.0|0.0|5.0|||Hodges-Lehmann Wilcoxon non-parametric||Positive values favour the first named treatment|||5.00|0.00|0.0016
72340011|NCT01831817|144203405|SUPERIORITY_OR_OTHER||Hodges-Lehmann shift|0.0||||0.01|TWO_SIDED|95.0|0.0|5.0|||Hodges-Lehmann Wilcoxon non-parametric||Positive values favour the first named treatment|||5.00|0.00|0.0100
72340012|NCT01831817|144203405|SUPERIORITY_OR_OTHER||Hodges-Lehmann shift|0.0||||0.002|TWO_SIDED|95.0|0.0|0.0|||Hodges-Lehmann Wilcoxon non-parametric||Positive values favour the second named treatment|||0.00|0.00|0.0020
72340013|NCT01831817|144203405|SUPERIORITY_OR_OTHER||Hodges-Lehmann shift|0.0||||0.0122|TWO_SIDED|95.0|0.0|0.0|||Hodges-Lehmann Wilcoxon non-parametric||Positive values favour the second named treatment|||0.00|0.00|0.0122
72340014|NCT01831817|144203405|SUPERIORITY_OR_OTHER||Hodges-Lehmann shift|0.0||||0.7138|TWO_SIDED|95.0|0.0|0.0|||Hodges-Lehmann Wilcoxon non-parametric||Positive values favour the first named treatment|||0.00|0.00|0.7138
72340015|NCT01831817|144203406|SUPERIORITY_OR_OTHER||Hodges-Lehmann shift|0.0||||0.9834|TWO_SIDED|95.0|-5.0|5.0|||Hodges-Lehmann Wilcoxon non-parametric||Positive values favour the first named treatment|||5.00|-5.00|0.9834
72340016|NCT01831817|144203406|SUPERIORITY_OR_OTHER||Hodges-Lehmann shift|5.0||||0.0001|TWO_SIDED|95.0|0.0|15.0|||Hodges-Lehmann Wilcoxon non-parametric||Positive values favour the first named treatment|||15.00|0.00|0.0001
72340017|NCT01831817|144203406|SUPERIORITY_OR_OTHER||Hodges-Lehmann shift|2.5||||0.0003|TWO_SIDED|95.0|0.0|15.0|||Hodges-Lehmann Wilcoxon non-parametric||Positive values favour the first named treatment|||15.00|0.00|0.0003
72340018|NCT01831817|144203406|SUPERIORITY_OR_OTHER||Hodges-Lehmann shift|-5.0|||<|0.0001|TWO_SIDED|95.0|-10.0|0.0|||Hodges-Lehmann Wilcoxon non-parametric||Positive values favour the second named treatment|||0.00|-10.00|<0.0001
72340019|NCT01831817|144203406|SUPERIORITY_OR_OTHER||Hodges-Lehmann shift|-5.0||||0.0002|TWO_SIDED|95.0|-10.0|0.0|||Hodges-Lehmann Wilcoxon non-parametric||Positive values favour the second named treatment|||0.00|-10.00|0.0002
72340020|NCT01831817|144203406|SUPERIORITY_OR_OTHER||Hodges-Lehmann shift|0.0||||0.2894|TWO_SIDED|95.0|0.0|0.0|||Hodges-Lehmann Wilcoxon non-parametric||Positive values favour the first named treatment|||0.00|0.00|0.2894
72340021|NCT01831817|144203407|SUPERIORITY_OR_OTHER||Mean change difference|-0.24||||0.5555|TWO_SIDED|95.0|-1.03|0.56|||ANCOVA||Treatment as fixed factor. Baseline Schiff strata and VRS as covariates. Difference is 1st named treatment - 2nd named treatment that a negative difference implies the mean of the 2nd named treatment is larger than that of the 1st named treatment|||0.56|-1.03|0.5555
72340022|NCT01831817|144203407|SUPERIORITY_OR_OTHER||Mean change difference|-0.06||||0.8769|TWO_SIDED|95.0|-0.86|0.73|||ANCOVA||Treatment as fixed factor. Baseline Schiff strata and VRS as covariates. Difference is 1st named treatment - 2nd named treatment that a negative difference implies the mean of the 2nd named treatment is larger than that of the 1st named treatment|||0.73|-0.86|0.8769
72340023|NCT01831817|144203407|SUPERIORITY_OR_OTHER||Mean change difference|-0.76||||0.0562|TWO_SIDED|95.0|-1.55|0.02|||ANCOVA||Treatment as fixed factor. Baseline Schiff strata and VRS as covariates. Difference is 1st named treatment - 2nd named treatment that a negative difference implies the mean of the 2nd named treatment is larger than that of the 1st named treatment|||0.02|-1.55|0.0562
72340024|NCT01831817|144203407|SUPERIORITY_OR_OTHER||Mean change difference|-0.18||||0.6562|TWO_SIDED|95.0|-0.95|0.6|||ANCOVA||Treatment as fixed factor. Baseline Schiff strata and VRS as covariates. Difference is 1st named treatment - 2nd named treatment that a negative difference implies the mean of the 2nd named treatment is larger than that of the 1st named treatment|||0.60|-0.95|0.6562
72340025|NCT01831817|144203407|SUPERIORITY_OR_OTHER||Mean change difference|0.53||||0.1788|TWO_SIDED|95.0|-0.24|1.3|||ANCOVA||Treatment as fixed factor. Baseline Schiff strata and VRS as covariates. Difference is 1st named treatment - 2nd named treatment that a negative difference implies the mean of the 2nd named treatment is larger than that of the 1st named treatment|||1.30|-0.24|0.1788
72340026|NCT01831817|144203407|SUPERIORITY_OR_OTHER||Mean change difference|-0.7||||0.0734|TWO_SIDED|95.0|-1.47|0.07|||ANCOVA||Treatment as fixed factor. Baseline Schiff strata and VRS as covariates. Difference is 1st named treatment - 2nd named treatment that a negative difference implies the mean of the 2nd named treatment is larger than that of the 1st named treatment|||0.07|-1.47|0.0734
72340027|NCT01831817|144203408|SUPERIORITY_OR_OTHER||Mean change difference|0.19||||0.6727|TWO_SIDED|95.0|-0.71|1.1|||ANCOVA||Treatment as fixed factor. Baseline Schiff strata and VRS as covariates. Difference is 1st named treatment - 2nd named treatment that a negative difference implies the mean of the 2nd named treatment is larger than that of the 1st named treatment|||1.10|-0.71|0.6727
72340028|NCT01831817|144203408|SUPERIORITY_OR_OTHER||Mean change difference|-1.24||||0.0072|TWO_SIDED|95.0|-2.14|-0.34|||ANCOVA||Treatment as fixed factor. Baseline Schiff strata and VRS as covariates. Difference is 1st named treatment - 2nd named treatment that a negative difference implies the mean of the 2nd named treatment is larger than that of the 1st named treatment|||-0.34|-2.14|0.0072
72340029|NCT01831817|144203408|SUPERIORITY_OR_OTHER||Mean change difference|-1.27||||0.0056|TWO_SIDED|95.0|-2.16|-0.38|||ANCOVA||Treatment as fixed factor. Baseline Schiff strata and VRS as covariates. Difference is 1st named treatment - 2nd named treatment that a negative difference implies the mean of the 2nd named treatment is larger than that of the 1st named treatment|||-0.38|-2.16|0.0056
72340030|NCT01831817|144203408|SUPERIORITY_OR_OTHER||Mean change diference|1.43||||0.0016|TWO_SIDED|95.0|0.56|2.31|||ANCOVA||Treatment as fixed factor. Baseline Schiff strata and VRS as covariates. Difference is 1st named treatment - 2nd named treatment that a negative difference implies the mean of the 2nd named treatment is larger than that of the 1st named treatment|||2.31|0.56|0.0016
72340031|NCT01831817|144203408|SUPERIORITY_OR_OTHER||Mean change difference|1.46||||0.0011|TWO_SIDED|95.0|0.59|2.33|||ANCOVA||Treatment as fixed factor. Baseline Schiff strata and VRS as covariates. Difference is 1st named treatment - 2nd named treatment that a negative difference implies the mean of the 2nd named treatment is larger than that of the 1st named treatment|||2.33|0.59|0.0011
72340032|NCT01831817|144203408|SUPERIORITY_OR_OTHER||Mean change difference|-0.03||||0.9413|TWO_SIDED|95.0|-0.9|0.84|||ANCOVA||Treatment as fixed factor. Baseline Schiff strata and VRS as covariates. Difference is 1st named treatment - 2nd named treatment that a negative difference implies the mean of the 2nd named treatment is larger than that of the 1st named treatment|||0.84|-0.90|0.9413
72340033|NCT01742065|144203421|SUPERIORITY|To assess effectiveness, we fit generalized estimating equations (GEE) with a logistic link to model patient-level data. We weighted patient data so that each clinic's data had an equal weight. Models were adjusted for age, sex, and health center. They used robust variance estimators and independent correlation structures. We specified clinic as a clustering variable to account for intraclinic correlation; the intraclinic correlation coefficient was 0.05 after model covariates adjustment.|Mean Difference (Final Values)|3.4||||0.05|TWO_SIDED|95.0|0.1|6.8||We report effectiveness as the absolute difference between intervention and usual care clinics in adjusted probabilities calculated using mean values for all covariates;|Generalized Estimating Equations (GEE)|Reported P values based on the corresponding adjusted odds ratio and account for reduced degrees of freedom owing to clustering.||||6.8|.1|.05
72340034|NCT01742065|144203422|OTHER|To assess effectiveness, we fit generalized estimating equations (GEE) with a logistic link to model patient-level data. We weighted patient data so that each clinic's data had an equal weight. Models were adjusted for age, sex, and health center. They used robust variance estimators and independent correlation structures. We specified clinic as a clustering variable to account for intraclinic correlation; the intraclass correlation coefficient was 0.05 after covariable adjustment.|Mean Difference (Final Values)|3.8||||0.02|TWO_SIDED|95.0|0.6|7.0||We report effectiveness as the absolute difference between intervention and usual care clinics in adjusted probabilities calculated using mean values for all covariates;|Generalized Estimating Equations (GEE)|Reported P values based on the corresponding adjusted odds ratio and account for reduced degrees of freedom owing to clustering.||||7|.6|.02
72340035|NCT04332614|144203473|SUPERIORITY||Odds Ratio (OR)|0.8791371||||0.0248|TWO_SIDED|95.0|0.7856042|0.9838058||We used an a priori threshold of p \< .05. All 3 comparisons run within same logistic regression model.|Regression, Logistic|||||0.9838058|0.7856042|0.0248
72340036|NCT04332614|144203473|SUPERIORITY||Odds Ratio (OR)|0.5980109|||<|0.0001|TWO_SIDED|95.0|0.5159511|0.6931219||We used an a priori threshold of p \< .05. All 3 comparisons run within same logistic regression model.|Regression, Logistic|||||0.6931219|0.5159511|<0.0001
72340037|NCT04332614|144203473|SUPERIORITY||Odds Ratio (OR)|0.8380003||||0.0133|TWO_SIDED|95.0|0.7285712|0.9638653||We used an a priori threshold of p \< .05. All 3 comparisons run within same logistic regression model.|Regression, Logistic|||||0.9638653|0.7285712|0.0133
72340038|NCT04332614|144203474|SUPERIORITY||Odds Ratio (OR)|0.3700794|||<|0.0001|TWO_SIDED|95.0|0.2870513|0.4771231||We used an a priori threshold of p \< .05. All 3 comparisons run within same logistic regression model.|Regression, Logistic|||||0.4771231|0.2870513|<0.0001
72340039|NCT04332614|144203474|SUPERIORITY||Odds Ratio (OR)|0.285144|||<|0.0001|TWO_SIDED|95.0|0.1881589|0.4321194||We used an a priori threshold of p \< .05. All 3 comparisons run within same logistic regression model.|Regression, Logistic|||||0.4321194|0.1881589|<0.0001
72340040|NCT04332614|144203474|SUPERIORITY||Odds Ratio (OR)|0.5565905||||0.0003|TWO_SIDED|95.0|0.4059477|0.7631354||We used an a priori threshold of p \< .05. All 3 comparisons run within same logistic regression model.|Regression, Logistic|||||0.7631354|0.4059477|0.0003
72340041|NCT04332614|144203475|SUPERIORITY||Odds Ratio (OR)|0.72429741||||0.103|TWO_SIDED|95.0|0.49167734|1.0669736||We used an a priori threshold of p \< .05. All 3 comparisons run within same logistic regression model.|Regression, Logistic|||||1.0669736|0.49167734|0.103
72340042|NCT04332614|144203475|SUPERIORITY||Odds Ratio (OR)|0.63578603||||0.12|TWO_SIDED|95.0|0.35943749|1.1246013||We used an a priori threshold of p \< .05. All 3 comparisons run within same logistic regression model.|Regression, Logistic|||||1.1246013|0.35943749|0.120
72340043|NCT04332614|144203475|SUPERIORITY||Odds Ratio (OR)|1.06482385||||0.789|TWO_SIDED|95.0|0.67282661|1.6852036||We used an a priori threshold of p \< .05. All 3 comparisons run within same logistic regression model.|Regression, Logistic|||||1.6852036|0.67282661|0.789
72340044|NCT04332614|144203476|SUPERIORITY||Odds Ratio (OR)|0.8837908||||0.0286|TWO_SIDED|95.0|0.7912382|0.9871694||We used an a priori threshold of p \< .05. All 3 comparisons run within same logistic regression model.|Regression, Logistic|||||0.9871694|0.7912382|0.0286
72340045|NCT04332614|144203476|SUPERIORITY||Odds Ratio (OR)|0.6000149|||<|0.0001|TWO_SIDED|95.0|0.5193168|0.6932528||We used an a priori threshold of p \< .05. All 3 comparisons run within same logistic regression model.|Regression, Logistic|||||0.6932528|0.5193168|<0.0001
72340046|NCT04332614|144203476|SUPERIORITY||Odds Ratio (OR)|0.8225743||||0.0055|TWO_SIDED|95.0|0.7167043|0.9440832|||Regression, Logistic|||||0.9440832|0.7167043|0.0055
72340047|NCT04332614|144203477|SUPERIORITY||Odds Ratio (OR)|0.3948795|||<|0.0001|TWO_SIDED|95.0|0.310437|0.5022914||We used an a priori threshold of p \< .05. All 3 comparisons run within same logistic regression model.|Regression, Logistic|||||0.5022914|0.3104370|<0.0001
72340048|NCT04332614|144203477|SUPERIORITY||Odds Ratio (OR)|0.2790595|||<|0.0001|TWO_SIDED|95.0|0.1875017|0.4153254||We used an a priori threshold of p \< .05. All 3 comparisons run within same logistic regression model.|Regression, Logistic|||||0.4153254|0.1875017|<0.0001
72340049|NCT04332614|144203477|SUPERIORITY||Odds Ratio (OR)|0.6097538||||0.0011|TWO_SIDED|95.0|0.4528751|0.8209762||We used an a priori threshold of p \< .05. All 3 comparisons run within same logistic regression model.|Regression, Logistic|||||0.8209762|0.4528751|0.0011
72370020|NCT00856518|144250525|SUPERIORITY_OR_OTHER|||||||0.946|||||||Plum Ordinal Regression Test|EMST arm vs. Sham arm group comparison of treatment response||||||0.946
72370021|NCT00856518|144250525|SUPERIORITY_OR_OTHER|||||||0.00042|||||||t-test, 2 sided|EMST arm post vs. pre-MEP comparison||||||0.00042
72370022|NCT00856518|144250525|SUPERIORITY_OR_OTHER|||||||0.0019||||||Sham arm post vs. pre-MEP comparison|t-test, 2 sided|||||||0.0019
72370023|NCT00856518|144250527|SUPERIORITY_OR_OTHER||||||>|0.05||||||EMST arm vs. Sham arm baseline total score and subscale score comparison|Wilcoxon (Mann-Whitney)|||||||> 0.05
72340050|NCT04332614|144203478|SUPERIORITY||Odds Ratio (OR)|1.0049587||||0.976|TWO_SIDED|95.0|0.72693253|1.3893201||We used an a priori threshold of p \< .05. All 3 comparisons run within same logistic regression model.|Regression, Logistic|||||1.3893201|0.72693253|0.976
72340051|NCT04332614|144203478|SUPERIORITY||Odds Ratio (OR)|0.7576895||||0.246|TWO_SIDED|95.0|0.4741259|1.2108458||We used an a priori threshold of p \< .05. All 3 comparisons run within same logistic regression model.|Regression, Logistic|||||1.2108458|0.47412590|0.246
72340052|NCT04332614|144203478|SUPERIORITY||Odds Ratio (OR)|1.1728665||||0.428|TWO_SIDED|95.0|0.79090107|1.7393021||We used an a priori threshold of p \< .05. All 3 comparisons run within same logistic regression model.|Regression, Logistic|||||1.7393021|0.79090107|0.428
72340053|NCT04332614|144203479|SUPERIORITY||Odds Ratio (OR)|0.9980487||||1|TWO_SIDED|95.0|0.8680298|1.147543||We used an a priori threshold of p \< .05. All 3 comparisons run within same logistic regression model, correcting for the 3 pairwise comparisons using Tukey's Contrasts.|Regression, Logistic|||||1.147543|0.8680298|1
72340054|NCT04332614|144203479|SUPERIORITY||Odds Ratio (OR)|0.8953032||||0.276|TWO_SIDED|95.0|0.7771682|1.031395||We used an a priori threshold of p \< .05. All 3 comparisons run within same logistic regression model, correcting for the 3 pairwise comparisons using Tukey's Contrasts.|Regression, Logistic|||||1.031395|0.7771682|0.276
72340055|NCT04332614|144203479|SUPERIORITY||Odds Ratio (OR)|0.8970536||||0.289|TWO_SIDED|95.0|0.7785981|1.033531||We used an a priori threshold of p \< .05. All 3 comparisons run within same logistic regression model, correcting for the 3 pairwise comparisons using Tukey's Contrasts.|Regression, Logistic|||||1.033531|0.7785981|0.289
72340056|NCT04332614|144203480|SUPERIORITY||Odds Ratio (OR)|0.9313889||||0.94591|TWO_SIDED|95.0|0.6003591|1.444944||We used an a priori threshold of p \< .05. All 3 comparisons run within same logistic regression model, correcting for the 3 pairwise comparisons using Tukey's Contrasts.|Regression, Logistic|||||1.444944|0.6003591|0.94591
72340057|NCT04332614|144203480|SUPERIORITY||Odds Ratio (OR)|1.8998642||||0.0041|TWO_SIDED|95.0|1.2809137|2.817898||We used an a priori threshold of p \< .05. All 3 comparisons run within same logistic regression model, correcting for the 3 pairwise comparisons using Tukey's Contrasts.|Regression, Logistic|||||2.817898|1.2809137|0.0041
72340058|NCT04332614|144203480|SUPERIORITY||Odds Ratio (OR)|2.0398184||||0.0015|TWO_SIDED|95.0|1.3648075|3.048678||We used an a priori threshold of p \< .05. All 3 comparisons run within same logistic regression model, correcting for the 3 pairwise comparisons using Tukey's Contrasts.|Regression, Logistic|||||3.048678|1.3648075|0.0015
72340059|NCT04332614|144203481|SUPERIORITY||Odds Ratio (OR)|1.180837||||0.829|TWO_SIDED|95.0|0.6750639|2.065546||We used an a priori threshold of p \< .05. All 3 comparisons run within same logistic regression model, correcting for the 3 pairwise comparisons using Tukey's Contrasts.|Regression, Logistic|||||2.065546|0.6750639|0.829
72340060|NCT04332614|144203481|SUPERIORITY||Odds Ratio (OR)|1.432003||||0.404|TWO_SIDED|95.0|0.8279689|2.476702||We used an a priori threshold of p \< .05. All 3 comparisons run within same logistic regression model, correcting for the 3 pairwise comparisons using Tukey's Contrasts.|Regression, Logistic|||||2.476702|0.8279689|0.404
72428396|NCT01327547|144367748|SUPERIORITY_OR_OTHER||Difference in LS mean|0.15||||0.2855|TWO_SIDED|95.0|-0.12|0.41|||ANCOVA||Difference in LS mean|The above analysis is change for baseline in Log10 plasma HCV RNA at 144 Weeks. Results are from an ANCOVA model with change from baseline as the response variable and the following fixed effect model terms: treatment (Maraviroc or placebo), baseline value of the response variable, HBV, PI-based regimen.||0.41|-0.12|0.2855
72340061|NCT04332614|144203481|SUPERIORITY||Odds Ratio (OR)|1.212702||||0.753|TWO_SIDED|95.0|0.7161724|2.05348||We used an a priori threshold of p \< .05. All 3 comparisons run within same logistic regression model, correcting for the 3 pairwise comparisons using Tukey's Contrasts.|Regression, Logistic|||||2.053480|0.7161724|0.753
72340062|NCT04332614|144203482|SUPERIORITY||Odds Ratio (OR)|0.9747188||||0.9284|TWO_SIDED|95.0|0.8501783|1.1175028||We used an a priori threshold of p \< .05. All 3 comparisons run within same logistic regression model, correcting for the 3 pairwise comparisons using Tukey's Contrasts.|Regression, Logistic|||||1.1175028|0.8501783|0.9284
72340063|NCT04332614|144203482|SUPERIORITY||Odds Ratio (OR)|0.8518974||||0.0612|TWO_SIDED|95.0|0.741461|0.9787827||We used an a priori threshold of p \< .05. All 3 comparisons run within same logistic regression model, correcting for the 3 pairwise comparisons using Tukey's Contrasts.|Regression, Logistic|||||0.9787827|0.7414610|0.0612
72340064|NCT04332614|144203482|SUPERIORITY||Odds Ratio (OR)|0.873993||||0.1407|TWO_SIDED|95.0|0.7602296|1.0047804||We used an a priori threshold of p \< .05. All 3 comparisons run within same logistic regression model, correcting for the 3 pairwise comparisons using Tukey's Contrasts.|Regression, Logistic|||||1.0047804|0.7602296|0.1407
72340065|NCT04332614|144203483|SUPERIORITY||Odds Ratio (OR)|0.9089673||||0.8848|TWO_SIDED|95.0|0.6109603|1.352333||We used an a priori threshold of p \< .05. All 3 comparisons run within same logistic regression model, correcting for the 3 pairwise comparisons using Tukey's Contrasts.|Regression, Logistic|||||1.352333|0.6109603|0.8848
72340066|NCT04332614|144203483|SUPERIORITY||Odds Ratio (OR)|1.6914929||||0.0127|TWO_SIDED|95.0|1.1762411|2.43245||We used an a priori threshold of p \< .05. All 3 comparisons run within same logistic regression model, correcting for the 3 pairwise comparisons using Tukey's Contrasts.|Regression, Logistic|||||2.432450|1.1762411|0.0127
72340067|NCT04332614|144203483|SUPERIORITY||Odds Ratio (OR)|1.8608951||||0.0033|TWO_SIDED|95.0|1.2800275|2.705356||We used an a priori threshold of p \< .05. All 3 comparisons run within same logistic regression model, correcting for the 3 pairwise comparisons using Tukey's Contrasts.|Regression, Logistic|||||2.705356|1.2800275|0.0033
72340068|NCT04332614|144203484|SUPERIORITY||Odds Ratio (OR)|0.8619131||||0.759|TWO_SIDED|95.0|0.5709078|1.301251||We used an a priori threshold of p \< .05. All 3 comparisons run within same logistic regression model, correcting for the 3 pairwise comparisons using Tukey's Contrasts.|Regression, Logistic|||||1.301251|0.5709078|0.759
72340069|NCT04332614|144203484|SUPERIORITY||Odds Ratio (OR)|1.0950508||||0.897|TWO_SIDED|95.0|0.7331329|1.635633||We used an a priori threshold of p \< .05. All 3 comparisons run within same logistic regression model, correcting for the 3 pairwise comparisons using Tukey's Contrasts.|Regression, Logistic|||||1.635633|0.7331329|0.897
72340070|NCT04332614|144203484|SUPERIORITY||Odds Ratio (OR)|1.2704886||||0.498|TWO_SIDED|95.0|0.8377249|1.926816||We used an a priori threshold of p \< .05. All 3 comparisons run within same logistic regression model, correcting for the 3 pairwise comparisons using Tukey's Contrasts.|Regression, Logistic|||||1.926816|0.8377249|0.498
72340071|NCT02937766|144203486|SUPERIORITY||Mean Difference (Final Values)|0.4|STANDARD_ERROR_OF_MEAN|0.25||0.093|TWO_SIDED|95.0|-0.1|0.9|||t-test, 2 sided|The t-test tested the hypothesis of no treatment difference between treatment groups.||||0.9|-0.1|0.093
72340072|NCT02937766|144203487|SUPERIORITY||Mean Difference (Final Values)|0.3|STANDARD_ERROR_OF_MEAN|0.22||0.234|TWO_SIDED|95.0|-0.2|0.7||The t-test tested the hypothesis of no treatment difference between treatment groups.|t-test, 2 sided|||||0.7|-0.2|0.234
72340073|NCT01657760|144203496|EQUIVALENCE|80% power to detect difference p\<0.05 two tailed|Mean Difference (Final Values)|0.01|STANDARD_DEVIATION|0.03||0.87|TWO_SIDED|||||ANOVA, uncorrected for MC.|ANOVA|||||||0.87
72340074|NCT01694108|144203520|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|Mann-Whitney-test comparing the decisional conflict scores of participating mothers vs. declining mothers.||||||<0.001
72340075|NCT02936284|144203568|SUPERIORITY||Mean Difference (Net)|0.196||||0.016|TWO_SIDED||||||Mixed Models Analysis|mixed effect regression model including covariates: child sex, child birth weight, breastfeeding duration, percent class attendance and covid grouping|difference between music and play group change|||||0.016
72340076|NCT02936284|144203569|SUPERIORITY||Mean Difference (Net)|29.9||||0.7|TWO_SIDED||||||Mixed Models Analysis||music group vs. play group baseline to 24 months|mixed effect regression analysis, unstructured covariance, no covariates. Reporting group x time interaction||||0.70
72340077|NCT02936284|144203570|SUPERIORITY||Mean Difference (Net)|0.073||||0.54|TWO_SIDED||||||Mixed Models Analysis||increase in weight for length z-score for music group|mixed-effect regression analysis with covariates: child sex, birth weight, breastfeeding duration, percent class attendance and covid categories||||0.540
72340078|NCT03921554|144203588|SUPERIORITY||Estimated change (52 weeks - baseline)|0.9|||<|0.0005|TWO_SIDED|95.0|0.5|1.2||The a priori threshold for statistical significance was \< 0.05.|Wald test||We fit a GEE model with AGS score as outcome and an indicator variable for 52 weeks. An exchangeable correlation structure was used to model intra-participant association of AGS scores. The model allowed for up to 2 measurements per participant.|"We are testing the null hypothesis is that the change from baseline (52 weeks - baseline) in AGS is zero.~45 participants had 2 measurements (at baseline and 52 weeks); 6 participants had 1 measurement (at baseline). All participants were included in the analysis."||1.2|0.5|<0.0005
72340079|NCT03921554|144203589|SUPERIORITY||Estimated change (Day 673 - Day 0)|1.09|||<|0.0005|TWO_SIDED|95.0|0.57|1.62||The a priori threshold for statistical significance was \<0.05.|Wald test||We fit a GEE model of AGS on day of treatment (modeled with cubic splines with knots at days 0, 84, 168, 336, 506, 673, and 1006). Goodness of fit criteria were used to select GEE model with AR(1) correlation structure.|We estimate change from Day 0 to Day 673 of treatment (Day 673 minus Day 0) with 95% confidence interval (CI). All participants are included in the analysis.||1.62|0.57|<0.0005
72340080|NCT03921554|144203590|SUPERIORITY||Estimated change (52 weeks - baseline)|2.2||||0.295|TWO_SIDED|95.0|-1.9|6.4||The a priori threshold for statistical significance was \<0.05.|Wald test||We fit a GEE model with GMFM-88 as outcome, with indicator variables for 52 weeks (vs. baseline) and cohorts B and C (vs. A); in addition, time by cohort interaction terms are included. The model allow for up to 2 measurements per participant.|"We are testing the null hypothesis that the change from baseline (52 weeks - baseline) in GMFM-88 is zero within cohorts.~35 participants had 2 measurements (at baseline and 52 weeks); 15 participants had 1 measurement (at baseline). All participants are included in the analysis."||6.4|-1.9|0.295
72340081|NCT03921554|144203590|SUPERIORITY||Estimated change (52 weeks - baseline)|7.0||||0.007|TWO_SIDED|95.0|1.9|12.0||The a priori threshold for statistical significance was \<0.05.|Wald test||We fit a GEE model with GMFM-88 as outcome, with indicator variables for 52 weeks (vs. baseline) and cohorts B and C (vs. A); in addition, time by cohort interaction terms are included. The model allow for up to 2 measurements per participant.|"We are testing the null hypothesis that the change from baseline (52 weeks - baseline) in GMFM-88 is zero within cohorts.~35 participants had 2 measurements (at baseline and 52 weeks); 15 participants had 1 measurement (at baseline). All participants are included in the analysis."||12.0|1.9|0.007
72340082|NCT03921554|144203590|SUPERIORITY||Estimated change (52 weeks - baseline)|0.26||||0.932|TWO_SIDED|95.0|-5.7|6.2||The a priori threshold for statistical significance was \<0.05.|Wald test||We fit a GEE model with GMFM-88 as outcome, with indicator variables for 52 weeks (vs. baseline) and cohorts B and C (vs. A); in addition, time by cohort interaction terms are included. The model allow for up to 2 measurements per participant.|"We are testing the null hypothesis that the change from baseline (52 weeks - baseline) in GMFM-88 is zero within cohorts.~35 participants had 2 measurements (at baseline and 52 weeks); 15 participants had 1 measurement (at baseline). All participants are included in the analysis."||6.2|-5.7|0.932
72340083|NCT03921554|144203591|SUPERIORITY||Estimated change (Day 3 - Day 0)|-8.76|||<|0.0005|TWO_SIDED|95.0|-11.7|-5.81||The a priori threshold for statistical significance was \<0.05.|Wald test||We fit a QLS model of ISG on day of treatment and indicator variable for post-treatment. Goodness of fit criteria were used to select QLS model with exchangeable correlation structure.|We estimate change from pre to post treatment (Day 3 minus Day 0) with 95% confidence interval (CI). All participants are included in the analysis.||-5.81|-11.7|<0.0005
72340084|NCT03921554|144203592|SUPERIORITY||Estimated change (day 335 minus day 0)|-0.11||||0.002|TWO_SIDED|95.0|-0.18|-0.04||The a priori threshold for statistical significance was \<0.05.|Wald test||We fit a GEE model of diary average score on day of treatment and indicator variable for post-treatment. Goodness of fit criteria were used to select GEE model with exchangeable correlation structure.|We estimate change from Day 0 to Day 335 (Day 335 - Day 0) with 95% confidence interval (CI). All participants are included in the analysis.||-0.04|-0.18|0.002
72340085|NCT01842581|144203605|NON_INFERIORITY|Threshold for significance=upper bound of the 2-sided 95% confidence interval (CI) for hazard ratio less than (\<) 1.56.|Hazard Ratio (HR)|1.959||||0.0359|TWO_SIDED|95.0|1.045|3.672|||Score statistics|||Hazard ratio estimate (hazard of breakthrough HE for rifaximin compared to rifaximin + lactulose) obtained from Cox proportional hazards model with effect for treatment, stratified by analysis region.||3.672|1.045|0.0359
72340086|NCT01842581|144203606|SUPERIORITY|2-sided test at a significance level of 0.05.|Hazard Ratio (HR)|1.739||||0.0985|TWO_SIDED|95.0|0.894|3.382||Threshold for significance at 0.05 level.|Log Rank|||Analysis was performed using log-rank test stratified by analysis region. Hazard ratio estimate (hazard of breakthrough HE for rifaximin compared to rifaximin + lactulose) obtained from Cox proportional hazards model with effect for treatment, stratified by analysis region.||3.382|0.894|0.0985
72340087|NCT00353873|144203642|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was tested using a one-sided significance level of 2.5%. If the lower confidence interval for the difference SFC-FP falls above -12 L/min the once daily SFC treatment combination was deemed to be statistically non-inferior. In the event that the lower confidence limit (2.5% 1-sided significance) exceeded 0, and using a separate closed testing procedure, superiority could be established.|Mean Difference (Net)|7.6|STANDARD_ERROR_OF_MEAN|3.01||0.012|TWO_SIDED|95.0|1.7|13.5|||ANCOVA|||||13.5|1.7|0.012
72340088|NCT00353873|144203643|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was tested using a one-sided significance level of 2.5%. If the lower confidence interval for the difference SFC-FP falls above -12 L/min the once daily SFC treatment combination was deemed to be statistically non-inferior. In the event that the lower confidence limit (2.5% 1-sided significance) exceeded 0, and using a separate closed testing procedure, superiority could be established.|Mean Difference (Net)|9.3|STANDARD_ERROR_OF_MEAN|3.08||0.003|TWO_SIDED|95.0|3.2|15.3|||ANCOVA|||||15.3|3.2|0.003
72340089|NCT00353873|144203644|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.31||||0.389|TWO_SIDED|95.0|0.7|2.4|||Regression, Logistic|||||2.4|0.7|0.389
72340090|NCT00353873|144203645|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.16||||0.535|TWO_SIDED|95.0|0.7|1.9|||Regression, Logistic|||||1.9|0.7|0.535
72340091|NCT00530920|144203655|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-1.43||||0.997|||||||Wilcoxon (Mann-Whitney)|||NULL HYPOTHESIS (H0): Median viral load reduction from baseline \>1.2 log10 copies/mL within each group||||0.997
72340092|NCT00530920|144203655|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-1.55||||1|||||||Wilcoxon (Mann-Whitney)|||NULL HYPOTHESIS (H0): Median viral load reduction from baseline \>1.2 log10 copies/mL within each group||||1
72340093|NCT00530920|144203655|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-1.47||||0.998|||||||Wilcoxon (Mann-Whitney)|||NULL HYPOTHESIS (H0): Median viral load reduction from baseline \>1.2 log10 copies/mL within each group||||0.998
72340094|NCT00707746|144203676|SUPERIORITY_OR_OTHER||||||<|0.001||||||Statistical significance was concluded if p ≤ 0.05.|t-test, 2 sided|||It was estimated that the standard deviation of the percent change in LDL-C was 20%. A sample size of 30 patients was planned for this study: 20 patients in the mipomersen group and 10 patients in the placebo group. A 2-sided t-test with an alpha level of 0.05 was expected to provide ≥90% power to detect a 30% difference in LDL-C percent reduction between the 2 groups (35% reduction for the mipomersen group and 5% reduction for the placebo group).||||<0.001
72340095|NCT00707746|144203679|SUPERIORITY_OR_OTHER||||||<|0.001||||||Inflation of type 1 error was controlled by specifying a small number of secondary parameters and a sequential inferential approach in which inferential conclusions about each successive parameter required statistical significance of the prior one.|Wilcoxon signed rank sum|||||||<0.001
72340096|NCT00707746|144203681|SUPERIORITY_OR_OTHER||||||<|0.001||||||Inflation of type 1 error was controlled by specifying a small number of secondary parameters and a sequential inferential approach in which inferential conclusions about each successive parameter required statistical significance of the prior one.|t-test, 2 sided|||||||<0.001
72340097|NCT00707746|144203683|SUPERIORITY_OR_OTHER||||||<|0.001||||||Inflation of type 1 error was controlled by specifying a small number of secondary parameters and a sequential inferential approach in which inferential conclusions about each successive parameter required statistical significance of the prior one.|t-test, 2 sided|||||||<0.001
72340098|NCT00707746|144203685|SUPERIORITY_OR_OTHER|||||||0.005||||||Statistical significance was concluded if p ≤0.05. No further adjustments were made for tertiary parameters.|t-test, 2 sided|||||||0.005
72428397|NCT01327547|144367749|SUPERIORITY_OR_OTHER||Difference in LS Mean|0.15||||0.7778|TWO_SIDED|95.0|-0.93|1.23|||ANCOVA||Difference in LS Mean|Results are from an ANCOVA model with change from baseline at Week 48 as the response variable and the following fixed effect model terms: treatment (Maraviroc or placebo), baseline value of the response variable, HBV, PI-based regimen.||1.23|-0.93|0.7778
72340099|NCT00707746|144203687|SUPERIORITY_OR_OTHER||||||<|0.001||||||Statistical significance was concluded if p ≤0.05. No further adjustments were made for tertiary parameters.|t-test, 2 sided|||||||<0.001
72340100|NCT00707746|144203689|SUPERIORITY_OR_OTHER|||||||0.006||||||Statistical significance was concluded if p ≤0.05. No further adjustments were made for tertiary parameters.|t-test, 2 sided|||||||0.006
72340101|NCT00707746|144203691|SUPERIORITY_OR_OTHER||||||<|0.001||||||Statistical significance was concluded if p ≤0.05. No further adjustments were made for tertiary parameters.|t-test, 2 sided|||||||<0.001
72340102|NCT00707746|144203693|SUPERIORITY_OR_OTHER|||||||0.784||||||Statistical significance was concluded if p ≤0.05. No further adjustments were made for tertiary parameters.|t-test, 2 sided|||||||0.784
72340103|NCT00707746|144203695|SUPERIORITY_OR_OTHER|||||||0.079||||||Statistical significance was concluded if p ≤0.05. No further adjustments were made for tertiary parameters.|t-test, 2 sided|||||||0.079
72340104|NCT05260333|144203699|OTHER||correlation coefficient|0.81||||0.0001|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||.0001
72340105|NCT00966719|144203746|OTHER||Risk Ratio (RR)|0.84||||0.4|TWO_SIDED|95.0|0.56|1.24|||Fisher Exact|||||1.24|0.56|0.40
72340106|NCT00966719|144203747|OTHER||Risk Ratio (RR)|1.15||||1|TWO_SIDED|95.0|0.44|3.02|||Fisher Exact|||||3.02|0.44|1
72340107|NCT00966719|144203748|OTHER||Risk Ratio (RR)|1.0||||1|TWO_SIDED|95.0|0.91|1.1|||Fisher Exact|||||1.10|0.91|1
72340108|NCT00966719|144203749|OTHER||Risk Ratio (RR)|1.03||||0.78|TWO_SIDED|95.0|0.85|1.26|||Fisher Exact|||||1.26|0.85|0.78
72340109|NCT00966719|144203750|OTHER||Risk Ratio (RR)|2.94||||0.32|TWO_SIDED|95.0|0.32|27.3|||Fisher Exact|||||27.30|0.32|0.32
72340110|NCT00966719|144203751|OTHER||Risk Ratio (RR)|1.5||||0.09|TWO_SIDED|95.0|0.95|2.38|||Fisher Exact|||||2.38|0.95|0.09
72340111|NCT00966719|144203752|OTHER||Risk Ratio (RR)|1.03||||0.77|TWO_SIDED|95.0|0.83|1.27|||Fisher Exact|||||1.27|0.83|0.77
72340112|NCT00966719|144203753|OTHER||Risk Ratio (RR)|1.36||||0.6|TWO_SIDED|95.0|0.58|3.15|||Fisher Exact|||||3.15|0.58|0.6
72340113|NCT01075971|144203768|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.77|||<|0.0001|TWO_SIDED|95.0|1.35|2.19||Analysis of variance with repeated measurements (daily scores from day 1 to day 5) for the whole set of patients was performed adjusted on the formulation (SL vs. FDT). Other independent factors were the subject and the day.|Analysis of variance|||||2.19|1.35|<0.0001
72340114|NCT02827500|144203787|SUPERIORITY||Odds Ratio, log|5.19||||0.002|TWO_SIDED|95.0|1.88|14.33|||Regression, Logistic|||||14.33|1.88|0.002
72340115|NCT02827500|144203788|SUPERIORITY|||||||0.011|||||||Regression, Linear|||||||0.011
72340116|NCT02827500|144203789|SUPERIORITY|||||||0.011|||||||Regression, Linear|||The null hypothesis tested was that there is no difference in change in heart rate between the treatment arms.||||0.011
72340117|NCT02827500|144203790|SUPERIORITY|||||||0.054||||||The apriori threshold for statistical significance is alpha=0.05.|Chi-squared, Corrected|The p-value is obtained using the F-test (combination of Chi-Squared tests) due to multiple imputation.||The null hypothesis tested was that there is no difference between the treatment arms in the proportion of patients with heart rate \< 70 BPM.||||0.054
72340118|NCT02827500|144203791|SUPERIORITY|||||||0.717|||||||Regression, Linear|||||||0.717
72340119|NCT02827500|144203792|SUPERIORITY|||||||0.784|||||||Regression, Linear|||||||0.784
72340120|NCT03474081|144203801|SUPERIORITY||Mean Difference (Net)|0.095|STANDARD_ERROR_OF_MEAN|0.0167|<|0.001|TWO_SIDED|95.0|0.062|0.128||The MMRM model included Baseline FEV1, visit, geographical region, and treatment as covariates and visit-by-Baseline FEV1 and visit-by-treatment interaction terms.|Mixed model repeated measures (MMRM)|||||0.128|0.062|<0.001
72340121|NCT03474081|144203802|SUPERIORITY||Mean Difference (Net)|0.122|STANDARD_ERROR_OF_MEAN|0.0144|<|0.001|TWO_SIDED|95.0|0.094|0.15||The MMRM model included Baseline FEV1, visit, geographical region, and treatment as covariates and visit-by-Baseline FEV1 and visit-by-treatment interaction terms.|Mixed model repeated measures (MMRM)|||||0.150|0.094|<0.001
72340122|NCT03474081|144203803|SUPERIORITY||Mean Difference (Net)|0.087|STANDARD_ERROR_OF_MEAN|0.0159|<|0.001|TWO_SIDED|95.0|0.056|0.118||The MMRM model included Baseline FEV1, visit, geographical region, and treatment as covariates and visit-by-Baseline FEV1 and visit-by-treatment interaction terms.|Mixed model repeated measures (MMRM)|||||0.118|0.056|<0.001
72340123|NCT05160766|144203862|OTHER||Difference of means in percent|12.557|STANDARD_ERROR_OF_MEAN|5.661||0.03143|TWO_SIDED|95.0|1.168|23.946|||ANCOVA|||The statistical analysis reflects Part A of the study.||23.946|1.168|0.03143
72340124|NCT05160766|144203862|OTHER||Difference of means in percent|4.331|STANDARD_ERROR_OF_MEAN|1.671||0.0101|TWO_SIDED|95.0|1.04|7.621|||ANCOVA|||This statistical analysis reflects Part B of the study.||7.621|1.04|0.0101
72340125|NCT05160766|144203863|OTHER||Difference of means in percent|12.168|STANDARD_ERROR_OF_MEAN|5.88||0.04405|TWO_SIDED|95.0|0.338|23.998|||ANCOVA|||This statistical analysis reflects Part A of the study.|"The above provided values refer to the variant B.1.1.7 (alpha)."|23.998|0.338|0.04405
72340126|NCT05160766|144203863|OTHER||Difference of means in percent|14.212|STANDARD_ERROR_OF_MEAN|5.767||0.01744|TWO_SIDED|95.0|2.61|25.814|||ANCOVA|||This statistical analysis reflects Part A of the study.|"The above provided values refer to the variant B.1.351 (beta)."|25.814|2.61|0.01744
72340127|NCT05160766|144203863|OTHER||Difference of means in percent|14.239|STANDARD_ERROR_OF_MEAN|5.932||0.02039|TWO_SIDED|95.0|2.305|26.173|||ANCOVA|||This statistical analysis reflects Part A of the study.|"The above provided values refer to the variant P.1 (gamma)."|26.173|2.305|0.02039
72340128|NCT05160766|144203863|OTHER||Difference of means in percent|9.331|STANDARD_ERROR_OF_MEAN|4.636||0.04989|TWO_SIDED|95.0|0.005|18.656|||ANCOVA|||This statistical analysis reflects Part A of the study.|"The above provided values refer to the variant BA.1 (omicron)."|18.656|0.005|0.04989
72340129|NCT05160766|144203863|OTHER||Difference of means in percent|10.312|STANDARD_ERROR_OF_MEAN|4.373||0.02259|TWO_SIDED|95.0|1.514|19.111|||ANCOVA|||This statistical analysis reflects Part A of the study.|"The above provided values refer to the variant BA.4 (omicron)."|19.111|1.514|0.02259
72340130|NCT05160766|144203863|OTHER||Difference of means in percent|11.601|STANDARD_ERROR_OF_MEAN|4.634||0.01583|TWO_SIDED|95.0|2.279|20.924|||ANCOVA|||This statistical analysis reflects Part A of the study.|"The above provided values refer to the variant BA.4.6 (omicron)."|20.924|2.279|0.01583
72340131|NCT05160766|144203863|OTHER||Difference of means in percent|11.863|STANDARD_ERROR_OF_MEAN|4.323||0.00856|TWO_SIDED|95.0|3.166|20.56|||ANCOVA|||This statistical analysis reflects Part A of the study.|"The above provided values refer to the variant BA.5 (omicron)."|20.56|3.166|0.00856
72340132|NCT05160766|144203863|OTHER||Difference of means in percent|6.83|STANDARD_ERROR_OF_MEAN|2.244||0.00258|TWO_SIDED|95.0|2.41|11.249|||ANCOVA|||This statistical analysis reflects Part B of the study.|"The above provided values refer to the variant B.1.1.7 (alpha)."|11.249|2.41|0.00258
72340133|NCT05160766|144203863|OTHER||Difference of means in percent|6.048|STANDARD_ERROR_OF_MEAN|2.244||0.00748|TWO_SIDED|95.0|1.63|10.466|||ANCOVA|||This statistical analysis reflects Part B of the study.|"The above provided values refer to the variant B.1.351 (beta)."|10.466|1.63|0.00748
72340134|NCT05160766|144203863|OTHER||Difference of means in percent|7.302|STANDARD_ERROR_OF_MEAN|2.782||0.00922|TWO_SIDED|95.0|1.821|12.782|||ANCOVA|||This statistical analysis reflects Part B of the study.|"The above provided values refer to the variant P.1 (gamma)."|12.782|1.821|0.00922
72340135|NCT05160766|144203863|OTHER||Difference of means in percent|4.791|STANDARD_ERROR_OF_MEAN|2.646||0.07136|TWO_SIDED|95.0|-0.419|10.001|||ANCOVA|||This statistical analysis reflects Part B of the study.|"The above provided values refer to the variant BA.1 (omicron)."|10.001|-0.419|0.07136
72340136|NCT05160766|144203863|OTHER||Difference of means in percent|3.965|STANDARD_ERROR_OF_MEAN|2.196||0.07218|TWO_SIDED|95.0|-0.36|8.29|||ANCOVA|||This statistical analysis reflects Part B of the study.|"The above provided values refer to the variant BA.4 (omicron)."|8.29|-0.36|0.07218
72340137|NCT05160766|144203863|OTHER||Difference of means in percent|4.82|STANDARD_ERROR_OF_MEAN|2.202||0.02949|TWO_SIDED|95.0|0.484|9.155|||ANCOVA|||This statistical analysis reflects Part B of the study.|"The above provided values refer to the variant BA.4.6 (omicron)."|9.155|0.484|0.02949
72340138|NCT05160766|144203863|OTHER||Difference of means in percent|3.926|STANDARD_ERROR_OF_MEAN|2.263||0.08403|TWO_SIDED|95.0|-0.531|8.382|||ANCOVA|||This statistical analysis reflects Part B of the study.|"The above provided values refer to the variant BA.5 (omicron)."|8.382|-0.531|0.08403
72340139|NCT05160766|144203866|OTHER||Difference of means in percent|8.835|STANDARD_ERROR_OF_MEAN|11.03||0.42797|TWO_SIDED|95.0|-13.475|31.145|||ANCOVA|||This statistical analysis reflects Part A of the study.|"The above provided values refer to the variant B.1.1.7 (alpha)."|31.145|-13.475|0.42797
72340140|NCT05160766|144203866|OTHER||Difference of means in percent|3.54|STANDARD_ERROR_OF_MEAN|10.575||0.73961|TWO_SIDED|95.0|-17.85|24.929|||ANCOVA|||This statistical analysis reflects Part A of the study.|"The above provided values refer to the variant B.1.351 (beta)."|24.929|-17.85|0.73961
72340141|NCT05160766|144203866|OTHER||Difference of means in percent|8.086|STANDARD_ERROR_OF_MEAN|10.683||0.4537|TWO_SIDED|95.0|-13.524|29.695|||ANCOVA|||This statistical analysis reflects Part A of the study.|"The above provided values refer to the variant P.1 (gamma)."|29.695|-13.524|0.45370
72340142|NCT05160766|144203866|OTHER||Difference of means in percent|1.636|STANDARD_ERROR_OF_MEAN|10.187||0.87323|TWO_SIDED|95.0|-18.969|22.241|||ANCOVA|||This statistical analysis reflects Part A of the study.|"The above provided values refer to the variant BA.1 (omicron)."|22.241|-18.969|0.87323
72340143|NCT05160766|144203866|OTHER||Difference of means in percent|0.81|STANDARD_ERROR_OF_MEAN|9.848||0.93489|TWO_SIDED|95.0|-19.109|20.728|||ANCOVA|||This statistical analysis relfects Part A of the study.|"The above provided values refer to the variant BA.4 (omicron)."|20.728|-19.109|0.93489
72340144|NCT05160766|144203866|OTHER||Difference of means in percent|3.511|STANDARD_ERROR_OF_MEAN|10.845||0.74784|TWO_SIDED|95.0|-18.425|25.448|||ANCOVA|||This statistical analysis reflects Part A of the study.|"The above provided values refer to the variant BA.4.6 (omicron)."|25.448|-18.425|0.74784
72340145|NCT05160766|144203866|OTHER||Difference of means in percent|2.088|STANDARD_ERROR_OF_MEAN|10.409||0.84202|TWO_SIDED|95.0|-18.966|23.143|||ANCOVA|||This statistical analysis reflects Part A of the study.|"The above provided values refer to the variant BA.5 (omicron)."|23.143|-18.966|0.84202
72340146|NCT05160766|144203866|OTHER||Difference of means in percent|5.807|STANDARD_ERROR_OF_MEAN|4.068||0.15477|TWO_SIDED|95.0|-2.207|13.821|||ANCOVA|||This statistical analysis reflects Part B of the study.|"The above provided values refer to the variant B.1.1.7 (alpha)."|13.821|-2.207|0.15477
72340147|NCT05160766|144203866|OTHER||Difference of means in percent|3.52|STANDARD_ERROR_OF_MEAN|3.984||0.37773|TWO_SIDED|95.0|-4.327|11.368|||ANCOVA|||This statistical analysis reflects Part B of the study.|"The above provided values refer to the variant B.1.351 (beta)."|11.368|-4.327|0.37773
72340148|NCT05160766|144203866|OTHER||Difference of means in percent|4.413|STANDARD_ERROR_OF_MEAN|4.18||0.29212|TWO_SIDED|95.0|-3.821|12.647|||ANCOVA|||This statistical analysis reflects Part B of the study.|"The above provided values refer to the variant P.1 (gamma)."|12.647|-3.821|0.29212
72340149|NCT05160766|144203866|OTHER||Difference of means in percent|5.961|STANDARD_ERROR_OF_MEAN|4.04||0.1414|TWO_SIDED|95.0|-1.998|13.919|||ANCOVA|||This statistical analysis reflects Part B of the study.|"The above provided values refer to the variant BA.1 (omicron)."|13.919|-1.998|0.14140
72340150|NCT05160766|144203866|OTHER||Difference of means in percent|2.199|STANDARD_ERROR_OF_MEAN|3.875||0.5709|TWO_SIDED|95.0|-5.434|9.832|||ANCOVA|||This statistical analysis reflects Part B of the study.|"The above provided values refer to the variant BA.4 (omicron)."|9.832|-5.434|0.57090
72340151|NCT05160766|144203866|OTHER||Difference of means in percent|6.528|STANDARD_ERROR_OF_MEAN|4.071||0.11012|TWO_SIDED|95.0|-1.491|14.548|||ANCOVA|||This statistical analysis reflects Part B of the study.|"The above provided values refer to the variant BA.4.6 (omicron)."|14.548|-1.491|0.11012
72340152|NCT05160766|144203866|OTHER||Difference of means in percent|4.239|STANDARD_ERROR_OF_MEAN|4.06||0.29755|TWO_SIDED|95.0|-3.759|12.237|||ANCOVA|||This statistical analysis reflects Part B of the study.|"The above provided values refer to the variant BA.5 (omicron)."|12.237|-3.759|0.29755
72340153|NCT05160766|144203871|OTHER||Difference of means in percent|9.64|STANDARD_ERROR_OF_MEAN|11.191||0.39426|TWO_SIDED|95.0|-12.995|32.275|||ANCOVA|||This statistical analysis reflects Part A of the study.|"The above provided values refer to the variant P.2 (gamma)."|32.275|-12.995|0.39426
72340154|NCT05160766|144203871|OTHER||Difference of means in percent|8.764|STANDARD_ERROR_OF_MEAN|10.765||0.42055|TWO_SIDED|95.0|-13.011|30.539|||ANCOVA|||This statistical analysis reflects Part A of the study.|"The above provided values refer to the variant B.1.617."|30.539|-13.011|0.42055
72340155|NCT05160766|144203871|OTHER||Difference of means in percent|8.472|STANDARD_ERROR_OF_MEAN|10.953||0.44391|TWO_SIDED|95.0|-13.683|30.627|||ANCOVA|||This statistical analysis reflects Part A of the study.|"The above provided values refer to the variant B.1.617.1 (kappa)."|30.627|-13.683|0.44391
72340156|NCT05160766|144203871|OTHER||Difference of means in percent|8.483|STANDARD_ERROR_OF_MEAN|10.82||0.43775|TWO_SIDED|95.0|-13.402|30.368|||ANCOVA|||This statistical analysis reflects Part A of the study.|"The above provided values refer to the variant AY.3 (delta)."|30.368|-13.402|0.43775
72340157|NCT05160766|144203871|OTHER||Difference of means in percent|6.19|STANDARD_ERROR_OF_MEAN|9.892||0.53511|TWO_SIDED|95.0|-13.819|26.2|||ANCOVA|||This statistical analysis reflects Part A of the study.|"The above provided values refer to the variant AY.4.2 (delta)."|26.2|-13.819|0.53511
72340158|NCT05160766|144203871|OTHER||Difference of means in percent|4.552|STANDARD_ERROR_OF_MEAN|10.801||0.67576|TWO_SIDED|95.0|-17.295|26.399|||ANCOVA|||This statistical analysis reflects Part A of the study.|"The above provided values refer to the variant B.1.617.3."|26.399|-17.295|0.67576
72340159|NCT05160766|144203871|OTHER||Difference of means in percent|8.438|STANDARD_ERROR_OF_MEAN|11.168||0.45443|TWO_SIDED|95.0|-14.15|31.027|||ANCOVA|||This statistical analysis reflects Part A of the study.|"The above provided values refer to the variant B.1.526.1 (iota)."|31.027|-14.15|0.45443
72340160|NCT05160766|144203871|OTHER||Difference of means in percent|8.901|STANDARD_ERROR_OF_MEAN|10.218||0.38904|TWO_SIDED|95.0|-11.768|29.569|||ANCOVA|||This statistical analysis reflects Part A of the study.|"The above provided values refer to the variant BA.2+L452M (omicron)."|29.569|-11.768|0.38904
72340161|NCT05160766|144203871|OTHER||Difference of means in percent|7.302|STANDARD_ERROR_OF_MEAN|10.11||0.47466|TWO_SIDED|95.0|-13.147|27.751|||ANCOVA|||This statistical analysis reflects Part A of the study.|"The above provided values refer to the variant BA.2+L452R (omicron)."|27.751|-13.147|0.47466
72340162|NCT05160766|144203871|OTHER||Difference of means in percent|2.878|STANDARD_ERROR_OF_MEAN|9.824||0.7711|TWO_SIDED|95.0|-16.993|22.749|||ANCOVA|||This statistical analysis reflects Part A of the study.|"The above provided values refer to the variant BA.2.12.1 (omicron)."|22.749|-16.993|0.77110
72340163|NCT05160766|144203871|OTHER||Difference of means in percent|1.753||||0.86646|TWO_SIDED|95.0|-19.195|22.701|||ANCOVA|||This statistical analysis reflects Part A of the study.|"The above provided values refer to the variant BA.2.75 (omicron)."|22.701|-19.195|0.86646
72340164|NCT05160766|144203871|OTHER||Difference of means in percent|5.42|STANDARD_ERROR_OF_MEAN|9.705||0.57972|TWO_SIDED|95.0|-14.21|25.049|||ANCOVA|||This statistical analysis reflects Part A of the study.|"The above provided values refer to the variant BA.2.75.2 (omicron)."|25.049|-14.21|0.57972
72340165|NCT05160766|144203871|OTHER||Difference of means in percent|1.17|STANDARD_ERROR_OF_MEAN|9.408||0.90166|TWO_SIDED|95.0|-17.859|20.199|||ANCOVA|||This statistical analysis reflects Part A of the study.|"The above provided values refer to the variant BA.3 (omicron)."|20.199|-17.859|0.90166
72340166|NCT05160766|144203871|OTHER||Difference of means in percent|1.018|STANDARD_ERROR_OF_MEAN|10.44||0.92279|TWO_SIDED|95.0|-20.099|22.136|||ANCOVA|||This statistical analysis reflects Part A of the study.|"The above provided values refer to the variant BF.7 (omicron)."|22.136|-20.099|0.92279
72340167|NCT05160766|144203871|OTHER||Difference of means in percent|3.532|STANDARD_ERROR_OF_MEAN|9.496||0.71191|TWO_SIDED|95.0|-15.675|22.74|||ANCOVA|||This statistical analysis reflects Part A of the study.|"The above provided values refer to the variant BQ.1 (omicron)."|22.74|-15.675|0.71191
72340168|NCT05160766|144203871|OTHER||Difference of means in percent|2.995|STANDARD_ERROR_OF_MEAN|8.755||0.73415|TWO_SIDED|95.0|-14.714|20.703|||ANCOVA|||This statistical analysis reflects Part A of the study.|"The above provided values refer to the variant BQ.1.1 (omicron)."|20.703|-14.714|0.73415
72340169|NCT05160766|144203871|OTHER||Difference of means in percent|7.157|STANDARD_ERROR_OF_MEAN|9.548||0.45798|TWO_SIDED|95.0|-12.155|26.469|||ANCOVA|||This statistical analysis reflects Part A of the study.|"The above provided values refer to the variant XBB.1 (omicron)."|26.469|-12.155|0.45798
72340170|NCT05160766|144203871|OTHER||Difference of means in percent|4.819|STANDARD_ERROR_OF_MEAN|4.055||0.23582|TWO_SIDED|95.0|-3.169|12.808|||ANCOVA|||This statistical analysis reflects Part B of the study.|"The above provided values refer to the variant P.2 (gamma)."|12.808|-3.169|0.23582
72340171|NCT05160766|144203871|OTHER||Difference of means in percent|5.312|STANDARD_ERROR_OF_MEAN|4.074||0.19354|TWO_SIDED|95.0|-2.713|13.337|||ANCOVA|||This statistical analysis reflects Part B of the study.|"The above provided values refer to the variant B.1.617."|13.337|-2.713|0.19354
72340172|NCT05160766|144203871|OTHER||Difference of means in percent|5.714|STANDARD_ERROR_OF_MEAN|4.155||0.17033|TWO_SIDED|95.0|-2.471|13.899|||ANCOVA|||This statistical analysis reflects Part B of the study.|"The above provided values refer to the variant B.1.617.1 (kappa)."|13.899|-2.471|0.17033
72340173|NCT05160766|144203871|OTHER||Difference of means in percent|5.934|STANDARD_ERROR_OF_MEAN|3.997||0.13895|TWO_SIDED|95.0|-1.94|13.808|||ANCOVA|||This statistical analysis reflects Part B of the study.|"The above provided values refer to the variant AY.3 (delta)."|13.808|-1.94|0.13895
72340174|NCT05160766|144203871|OTHER||Difference of means in percent|4.222|STANDARD_ERROR_OF_MEAN|3.812||0.26924|TWO_SIDED|95.0|-3.288|11.732|||ANCOVA|||This statistical analysis reflects Part B of the study.|"The above provided values refer to the variant AY.4.2 (delta)."|11.732|-3.288|0.26924
72340175|NCT05160766|144203871|OTHER||Difference of means in percent|5.49|STANDARD_ERROR_OF_MEAN|3.996||0.1708|TWO_SIDED|95.0|-2.382|13.362|||ANCOVA|||This statistical analysis reflects Part B of the study.|"The above provided values refer to the variant B.1.617.3."|13.362|-2.382|0.17080
72340176|NCT05160766|144203871|OTHER||Difference of means in percent|5.567|STANDARD_ERROR_OF_MEAN|4.188||0.18502|TWO_SIDED|95.0|-2.683|13.818|||ANCOVA|||This statistical analysis reflects Part B of the study.|"The above provided values refer to the variant B.1.526.1 (iota)."|13.818|-2.683|0.18502
72340177|NCT05160766|144203871|OTHER||Difference of means in percent|3.438|STANDARD_ERROR_OF_MEAN|3.938||0.38344|TWO_SIDED|95.0|-4.318|11.195|||ANCOVA|||This statistical analysis reflects Part B of the study.|"The above provided values refer to the variant BA.2+L452M (omicron)."|11.195|-4.318|0.38344
72340178|NCT05160766|144203871|OTHER||Difference of means in percent|3.279|STANDARD_ERROR_OF_MEAN|3.982||0.411|TWO_SIDED|95.0|-4.565|11.124|||ANCOVA|||This statistical analysis reflects Part B of the study.|"The above provided values refer to the variant BA.2+L452R (omicron)."|11.124|-4.565|0.41100
72340179|NCT05160766|144203871|OTHER||Difference of means in percent|2.67|STANDARD_ERROR_OF_MEAN|4.014||0.5066|TWO_SIDED|95.0|-5.237|10.577|||ANCOVA|||This statistical analysis reflects Part B of the study.|"The above provided values refer to the variant BA.2.12.1 (omicron)."|10.577|-5.237|0.50660
72340180|NCT05160766|144203871|OTHER||Difference of means in percent|4.535|STANDARD_ERROR_OF_MEAN|4.242||0.28604|TWO_SIDED|95.0|-3.82|12.891|||ANCOVA|||This statistical analysis reflects Part B of the study.|"The above provided values refer to the variant BA.2.75 (omicron)."|12.891|-3.82|0.28604
72340181|NCT05160766|144203871|OTHER||Difference of means in percent|6.259|STANDARD_ERROR_OF_MEAN|3.98||0.11715|TWO_SIDED|95.0|-1.582|14.1|||ANCOVA|||This statistical analysis reflects Part B of the study.|"The above provided values refer to the variant BA.2.75.2 (omicron)."|14.1|-1.582|0.11715
72340182|NCT05160766|144203871|OTHER||Difference of means in percent|3.818|STANDARD_ERROR_OF_MEAN|3.957||0.33567|TWO_SIDED|95.0|-3.978|11.613|||ANCOVA|||This statistical analysis reflects Part B of the study.|"The above provided values refer to the variant BA.3 (omicron)."|11.613|-3.978|0.33567
72340183|NCT05160766|144203871|OTHER||Difference of means in percent|5.775|STANDARD_ERROR_OF_MEAN|4.022||0.15232|TWO_SIDED|95.0|-2.147|13.697|||ANCOVA|||This statistical analysis reflects Part B of the study.|"The above provided values refer to the variant BF.7 (omicron)."|13.697|-2.147|0.15232
72340184|NCT05160766|144203871|OTHER||Difference of means in percent|4.808|STANDARD_ERROR_OF_MEAN|3.845||0.21234|TWO_SIDED|95.0|-2.766|12.383|||ANCOVA|||This statistical analysis reflects Part B of the study.|"The above provided values refer to the variant BQ.1 (omicron)."|12.383|-2.766|0.21234
72340185|NCT05160766|144203871|OTHER||Difference of means in percent|4.58|STANDARD_ERROR_OF_MEAN|3.78||0.22687|TWO_SIDED|95.0|-2.866|12.026|||ANCOVA|||This statistical analysis reflects Part B of the study.|"The above provided values refer to the variant BQ.1.1 (omicron)."|12.026|-2.866|0.22687
72340186|NCT05160766|144203871|OTHER||Difference of means in percent|3.498|STANDARD_ERROR_OF_MEAN|4.047||0.38832|TWO_SIDED|95.0|-4.475|11.47|||ANCOVA|||This statistical analysis reflects Part B of the study.|"The above provided values refer to the variant XBB.1 (omicron)."|11.47|-4.475|0.38832
72340187|NCT03859739|144203877|SUPERIORITY|Adjusted by Placebo data pooled from historical placebo data from recent monotherapy studies in HIV-1 infected participants (NCT00100048, NCT01466985, NCT01152255, and NCT01353898) and fitted with a LDA model containing fixed effects for study and time, and a random effect for participants.|Posterior Mean Difference|-0.79|||||||||||||Posterior Probability (PP) of true mean difference in the plasma HIV-1 RNA change from baseline between MK-8558 and placebo ≤ -1.4 copies/mL was 2.44 %.|It was hypothesized that the true mean difference in the plasma HIV-1 RNA reduction from baseline between MK-8558 and placebo is ≥ 1.4 log10 copies/mL.||||
72370024|NCT00856518|144250527|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Plum Ordinal Regression Test|EMST arm vs. Sham arm group comparison of treatment response for total score and all subscale scores except for Burden and Pharyngeal domains||||||> 0.05
72370025|NCT00856518|144250527|SUPERIORITY_OR_OTHER|||||||0.014|||||||Plum Ordinal Regression Test|EMST arm vs. Sham arm group comparison of treatment response in Burden domain||||||0.014
72340188|NCT03859739|144203877|SUPERIORITY|Adjusted by Placebo data pooled from historical placebo data from recent monotherapy studies in HIV-1 infected participants (NCT00100048, NCT01466985, NCT01152255, and NCT01353898) and fitted with a LDA model containing fixed effects for study and time, and a random effect for participants.|Posterior Mean Difference|-0.97|||||||||||||PP of true mean difference in the plasma HIV-1 RNA change from baseline between MK-8558 and placebo ≤ -1.4 copies/mL was 7.60%.|It was hypothesized that the true mean difference in the plasma HIV-1 RNA reduction from baseline between MK-8558 and placebo is ≥ 1.4 log10 copies/mL.||||
72340189|NCT03859739|144203877|SUPERIORITY|Adjusted by Placebo data pooled from historical placebo data from recent monotherapy studies in HIV-1 infected participants (NCT00100048, NCT01466985, NCT01152255, and NCT01353898) and fitted with a LDA model containing fixed effects for study and time, and a random effect for participants.|Posterior Mean Difference|-1.58|||||||||||||PP of true mean difference in the plasma HIV-1 RNA change from baseline between MK-8558 and placebo ≤ -1.4 copies/mL was 74.99%.|It was hypothesized that the true mean difference in the plasma HIV-1 RNA reduction from baseline between MK-8558 and placebo is ≥ 1.4 log10 copies/mL.||||
72340190|NCT03859739|144203877|SUPERIORITY|Adjusted by Placebo data pooled from historical placebo data from recent monotherapy studies in HIV-1 infected participants (NCT00100048, NCT01466985, NCT01152255, and NCT01353898) and fitted with a LDA model containing fixed effects for study and time, and a random effect for participants.|Posterior Mean Difference|-1.78|||||||||||||PP of true mean difference in the plasma HIV-1 RNA change from baseline between MK-8558 and placebo ≤ -1.4 copies/mL was 87.41%.|It was hypothesized that the true mean difference in the plasma HIV-1 RNA reduction from baseline between MK-8558 and placebo is ≥ 1.4 log10 copies/mL.||||
72340191|NCT03859739|144203885|OTHER||Standard Error (SE)|0.146|||||||||||||PP that the true C168hr in plasma MK-8558 is ≥ 9.0 μM was 0.25%.|The posterior probability (PP) that the true GM C168hr is ≥ 9.0 μM was calculated using a non-informative (Jeffrey's) prior under an assumption of normality of log C168hr.||||
72340192|NCT03859739|144203885|OTHER||SE|0.146|||||||||||||PP that the true C168hr in plasma MK-8558 is ≥ 9.0 μM was 65.41%.|The PP that the true GM C168hr is ≥ 9.0 μM was calculated using a non-informative (Jeffrey's) prior under an assumption of normality of log C168hr.||||
72340193|NCT03859739|144203885|OTHER||SE|0.133|||||||||||||PP that the true C168hr in plasma MK-8558 is ≥ 9.0 μM was 99.99%.|The PP that the true GM C168hr is ≥ 9.0 μM was calculated using a non-informative (Jeffrey's) prior under an assumption of normality of log C168hr.||||
72340194|NCT03859739|144203885|OTHER||SE|0.163|||||||||||||PP that the true C168hr in plasma MK-8558 is ≥ 9.0 μM was 99.98%.|The PP that the true GM C168hr is ≥ 9.0 μM was calculated using a non-informative (Jeffrey's) prior under an assumption of normality of log C168hr.||||
72340195|NCT00673881|144203982|SUPERIORITY_OR_OTHER|||||||0.0042||95.0|||||t-test, 2 sided|||||||0.0042
72340196|NCT00673881|144203983|SUPERIORITY_OR_OTHER|||||||0.0002|||||||t-test, 2 sided|||Comparison baseline to end-of-treatment||||0.0002
72340197|NCT00673881|144203984|SUPERIORITY_OR_OTHER||||||NS|0|||||||t-test, 2 sided|||Comparison from baseline to end-of-treatment||||NS
72340198|NCT00673881|144203992|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||||||<0.0001
72340199|NCT00689793|144203996|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.0|STANDARD_DEVIATION|2.5||0.69|TWO_SIDED|95.0|0.0|10.0||Significant level of treatment effect was set at p\<0.05|Regression, Linear|Level of fatigue at four weeks:dependant variable. Group allocation and level of fatigue at baseline: independant variables.||The null hypothesis was that there was no difference in fatigue VAS scores between the treatment and placebo groups at 4 weeks||10|0|0.69
72340200|NCT00689793|144203997|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.0|STANDARD_DEVIATION|6.5|<|0.05||95.0|0.0|10.0|||Regression, Linear|Hemoglobin value at four weeks : dependant variable. Group allocation and hemoglobin value at baseline : independant variables.||||10|0|<0.05
72340201|NCT00689793|144203998|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|15.0|STANDARD_DEVIATION|8.0|<|0.05|TWO_SIDED|95.0|0.0|30.0|||Regression, Linear|Ferritin level at 4 weeks : dependant variable. Group allocation and ferritin level at baseline: independant variables.||||30|0|<0.05
72340202|NCT00689793|144203999|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.0|STANDARD_DEVIATION|3.0||0.05|TWO_SIDED|95.0|0.0|6.0|||Regression, Linear|Aerobic capacity at 4 weeks : dependant variables. Group allocation and aerobic capacity at baseline : independant variable.||||6|0|0.05
72340203|NCT03968159|144204006|SUPERIORITY||LSM difference|-0.9|STANDARD_ERROR_OF_MEAN|0.82||0.2956|TWO_SIDED|95.0|-2.5|0.8|||Mixed-effects model for repeated measure|||||0.8|-2.5|0.2956
72340204|NCT01299571|144204020|SUPERIORITY_OR_OTHER||Percentage of participants|3.8||||||95.0|3.2|4.4|||||The estimated value represents the percentage of participants with adverse events.|||4.4|3.2|
72340205|NCT00316888|144204049|SUPERIORITY_OR_OTHER_LEGACY|||||||0.218|||||||one sample binomial test|||Null hypothesis is that the local failure rate at 3 years is no more than 35%.||||0.218
72340206|NCT00316888|144204049|SUPERIORITY_OR_OTHER_LEGACY|||||||0.592|||||||one sample binomial test|||The null hypothesis is that the local failure rate at 3 years is no more than 35%.||||0.592
72340207|NCT00815191|144204058|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority delta of 0.5°C|Mean Difference (Final Values)|0.091|||<|0.0001|TWO_SIDED|95.0|-0.139|0.321|||ANOVA|Repeated measures ANOVA||||0.321|-0.139|<0.0001
72340208|NCT01291836|144204059|SUPERIORITY_OR_OTHER_LEGACY||Area under Receiver-Operator Curve (ROC)|0.658|||||TWO_SIDED|95.0|0.586|0.73||||||Null Hypothesis: ROC AUC of 0.58; using a one-sided z-test at a significance level of 0.025. Efficacy determined by the evaluation of the area under the Receiver Operator Curve (ROC) generated from the study primary endpoint data. The units on both axes of the ROC curve are dimensionless proportions from 0 to 1.|Efficacy determined by the evaluation of the area under the Receiver Operator Curve (ROC) generated from the study primary endpoint data. The units on both axes of the ROC curve are dimensionless proportions from 0 to 1.|0.73|0.586|
72340209|NCT01291836|144204060|SUPERIORITY_OR_OTHER_LEGACY||ROC AUC|0.65|||||TWO_SIDED|95.0|0.598|0.702||||||Null Hypothesis: AUC ≤0.55, using a one-sided z-test at a significance level of 0.025. Efficacy determined by the evaluation of the area under the Receiver Operator Curve (ROC) generated from the study primary endpoint data. The units on both axes of the ROC curve are dimensionless proportions from 0 to 1.|Efficacy determined by the evaluation of the area under the Receiver Operator Curve (ROC) generated from the study primary endpoint data. The units on both axes of the ROC curve are dimensionless proportions from 0 to 1.|0.702|0.598|
72340210|NCT02576860|144204082|SUPERIORITY|||||||0.799|||||||ANCOVA|||||||0.799
72340211|NCT02576860|144204083|SUPERIORITY|||||||0.858|||||||Cochran-Mantel-Haenszel|||||||0.858
72340212|NCT01541917|144204089|SUPERIORITY_OR_OTHER||Slope|-0.04|STANDARD_ERROR_OF_MEAN|0.01|<|0.001|TWO_SIDED|95.0|-0.06|-0.02|||Multilevel growth model|Adjusted for baseline values|The parameter represents the average monthly change on the outcome variable since group procedures were initiated.|Multilevel growth model evaluating average change over time (regardless of group) on the outcome variable||-.02|-.06|<.001
72340213|NCT01541917|144204089|SUPERIORITY_OR_OTHER||Slope|-0.014|STANDARD_ERROR_OF_MEAN|0.021||0.51|TWO_SIDED|95.0|-0.055|0.027|||Multilevel growth model||The estimated parameter value represents the difference in the monthly change (since baseline) in the outcome variable attributed to being in the treatment group (web-based coping skills training) versus the control group (online disease education).|Multilevel linear growth modeling was used for analyses, with the time variable coded as months since randomization. All models included an adjustment for baseline group differences on the outcome variable.||.027|-.055|.51
72340214|NCT01541917|144204090|SUPERIORITY_OR_OTHER||Slope|0.37|STANDARD_ERROR_OF_MEAN|0.05|<|0.001|TWO_SIDED|95.0|0.27|0.46|||Multilevel growth model|Adjusted for baseline values.|The parameter represents the average monthly change on the outcome variable since before group procedures were started.|Multilevel growth model evaluating average change over time on the outcome variable||.46|.27|<.001
72340215|NCT01541917|144204090|SUPERIORITY_OR_OTHER||Slope|0.053|STANDARD_ERROR_OF_MEAN|0.101||0.59|TWO_SIDED|95.0|-0.144|0.252|||Multilevel growth model|Adjusted for baseline values on the outcome variable|The estimated parameter value represents the difference in the monthly change (since baseline) in the outcome variable attributed to being in the treatment group (web-based coping skills training) versus the control group (online disease education).|Multilevel linear growth modeling was used for analyses, with the time variable coded as months since randomization. All models included an adjustment for baseline group differences on the outcome variable.||.252|-.144|.59
72340216|NCT01541917|144204091|SUPERIORITY_OR_OTHER||Slope|0.12|STANDARD_ERROR_OF_MEAN|0.01|<|0.001|TWO_SIDED|95.0|0.1|0.14|||Multilevel growth model|Adjusted for baseline values|The parameter represents the average monthly change on the outcome variable since before group procedures were started|Multilevel growth model evaluating average change over time on the outcome variable||.14|.10|<.001
72340217|NCT01541917|144204091|SUPERIORITY_OR_OTHER||Slope|-0.01|STANDARD_ERROR_OF_MEAN|0.02||0.63|TWO_SIDED|95.0|-0.05|0.03|||Multilevel growth model|Adjusted for baseline values on the outcome variable|The estimated parameter value represents the difference in the monthly change (since baseline) in the outcome variable attributed to being in the treatment group (web-based coping skills training) versus the control group (online disease education).|Multilevel linear growth modeling was used for analyses, with the time variable coded as months since randomization. All models included an adjustment for baseline group differences on the outcome variable.||.03|-.05|.63
72340218|NCT01541917|144204092|SUPERIORITY_OR_OTHER||Slope|-0.1|STANDARD_ERROR_OF_MEAN|0.04||0.02|TWO_SIDED|95.0|-0.18|-0.01|||Multilevel growth model|Adjusted for baseline values|The parameter represents the average monthly change on the outcome variable since before group procedures were started.|Multilevel growth model evaluating average change over time on the outcome variable||-.01|-.18|.02
72340219|NCT01541917|144204092|SUPERIORITY_OR_OTHER||Slope|-0.009|STANDARD_ERROR_OF_MEAN|0.084||0.91|TWO_SIDED|95.0|-0.174|0.155|||Multilevel growth model|Adjusted for baseline values on the outcome variable|The estimated parameter value represents the difference in the monthly change (since baseline) in the outcome variable attributed to being in the treatment group (web-based coping skills training) versus the control group (online disease education).|Multilevel linear growth modeling was used for analyses, with the time variable coded as months since randomization. All models included an adjustment for baseline group differences on the outcome variable.||.155|-.174|.91
72340220|NCT01541917|144204093|SUPERIORITY_OR_OTHER||Slope|0.0316|STANDARD_ERROR_OF_MEAN|0.004|<|0.001|TWO_SIDED|95.0|0.02|0.04|||Multilevel growth model|Adjusted for baseline values.|The parameter represents the average monthly change on the outcome variable since before group procedures were started|Multilevel growth model evaluating average change over time on the outcome variable||.04|.02|<.001
72340221|NCT01541917|144204093|SUPERIORITY_OR_OTHER||Slope|-0.004|STANDARD_ERROR_OF_MEAN|0.008||0.67|TWO_SIDED|95.0|-0.02|0.013|||Multilevel growth model|Adjusted for baseline values on the outcome variable|The estimated parameter value represents the difference in the monthly change (since baseline) in the outcome variable attributed to being in the treatment group (web-based coping skills training) versus the control group (online disease education).|Multilevel linear growth modeling was used for analyses, with the time variable coded as months since randomization. All models included an adjustment for baseline group differences on the outcome variable.||.013|-.02|.67
72340222|NCT01541917|144204094|SUPERIORITY_OR_OTHER||Slope|-0.002|STANDARD_ERROR_OF_MEAN|0.004||0.58|TWO_SIDED|95.0|-0.01|0.01|||Multilevel growth model|Adjusted for baseline values|The parameter represents the average monthly change on the outcome variable since before group procedures were started.|Multilevel growth model evaluating average change over time on the outcome variable||.01|-.01|.58
72340223|NCT01541917|144204094|SUPERIORITY_OR_OTHER||Slope|0.005|STANDARD_ERROR_OF_MEAN|0.007||0.49|TWO_SIDED|95.0|-0.009|0.018|||Multilevel growth model|Adjusted for baseline values on the outcome variable|The estimated parameter value represents the difference in the monthly change (since baseline) in the outcome variable attributed to being in the treatment group (web-based coping skills training) versus the control group (online disease education).|Multilevel linear growth modeling was used for analyses, with the time variable coded as months since randomization. All models included an adjustment for baseline group differences on the outcome variable.||.018|-.009|.49
72340224|NCT01014455|144204098|SUPERIORITY_OR_OTHER|||||||0.672||95.0|||||t-test, 2 sided|||||||0.672
72340225|NCT04728594|144204118|SUPERIORITY||Odds Ratio (OR)|2.11|||<|0.001|TWO_SIDED|95.0|1.65|2.69||We used an a priori threshold of p \< .05.|Regression, Logistic|||We conducted a logistic regression with the two experimental conditions as dummy variables with delayed contact as the reference group.||2.69|1.65|<.001
72340226|NCT04728594|144204118|SUPERIORITY||Odds Ratio (OR)|2.26|||<|0.001|TWO_SIDED|95.0|1.77|2.87||We used an a priori threshold of p \< .05.|Regression, Logistic|||We conducted a logistic regression with the two experimental conditions as dummy variables with delayed contact as the reference group.||2.87|1.77|<.001
72340227|NCT04728594|144204118|SUPERIORITY||Odds Ratio (OR)|1.07|||<|0.001|TWO_SIDED|95.0|0.88|1.3||We used an a priori threshold of p \< .05.|Regression, Logistic|||We conducted a logistic regression with the two experimental conditions as dummy variables with delayed contact as the reference group.||1.30|0.88|<.001
72340228|NCT00128713|144204140|SUPERIORITY_OR_OTHER|||||||0.83||||||Three one-degree-of-freedom chi-square tests, each comparing a pair of treatment groups. These tests were carried out at the .017 significance level to adjust for the multiple comparisons.|Fisher Exact|These tests were carried out at the .017 significance level to adjust for the multiple comparisons.||||||0.83
72340229|NCT00128713|144204140|SUPERIORITY_OR_OTHER|||||||0.83||||||Three one-degree-of-freedom chi-square tests, each comparing a pair of treatment groups. These tests were carried out at the .017 significance level to adjust for the multiple comparisons.|Fisher Exact|These tests were carried out at the .017 significance level to adjust for the multiple comparisons.||||||0.83
72340230|NCT00128713|144204140|SUPERIORITY_OR_OTHER|||||||0.66||||||Three one-degree-of-freedom chi-square tests, each comparing a pair of treatment groups. These tests were carried out at the .017 significance level to adjust for the multiple comparisons.|Fisher Exact|These tests were carried out at the .017 significance level to adjust for the multiple comparisons.||||||0.66
72340231|NCT00128713|144204141|SUPERIORITY_OR_OTHER|||||||0.02||||||All analyses are based on intention to treat. These tests were carried out at the .017 significance level to adjust for the multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.02
72340232|NCT00128713|144204141|SUPERIORITY_OR_OTHER||||||<|0.001||||||All analyses are based on intention to treat. These tests were carried out at the .017 significance level to adjust for the multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||<0.001
72340233|NCT00128713|144204141|SUPERIORITY_OR_OTHER||||||<|0.001||||||All analyses are based on intention to treat. These tests were carried out at the .017 significance level to adjust for the multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||<0.001
72340234|NCT00128713|144204142|SUPERIORITY_OR_OTHER||||||<|0.001||||||All analyses were carried out using intention to treat. These tests were carried out at the .017 significance level to adjust for the multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||<0.001
72340235|NCT00128713|144204142|SUPERIORITY_OR_OTHER||||||<|0.001||||||All analyses were carried out using intention to treat. These tests were carried out at the .017 significance level to adjust for the multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||<0.001
72340236|NCT00128713|144204142|SUPERIORITY_OR_OTHER|||||||0.16||||||All analyses were carried out using intention to treat. These tests were carried out at the .017 significance level to adjust for the multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.16
72340237|NCT00128713|144204144|SUPERIORITY_OR_OTHER|||||||0.51||||||Each pair of treatment arms was compared using an exact version of the Mantel-Haenszel test for trend.|Mantel Haenszel|These tests will be carried out at the .017 significance level to adjust for the multiple comparisons||||||0.51
72340238|NCT00128713|144204144|SUPERIORITY_OR_OTHER|||||||0.82||||||Each pair of treatment arms was compared using an exact version of the Mantel-Haenszel test for trend.|Mantel Haenszel|These tests will be carried out at the .017 significance level to adjust for the multiple comparisons||||||0.82
72340239|NCT00128713|144204144|SUPERIORITY_OR_OTHER|||||||0.68||||||Each pair of treatment arms was compared using an exact version of the Mantel-Haenszel test for trend.|Mantel Haenszel|These tests will be carried out at the .017 significance level to adjust for the multiple comparisons||||||0.68
72340240|NCT00424268|144204145|SUPERIORITY_OR_OTHER||Mean Difference (Net)|80.0|STANDARD_ERROR_OF_MEAN|15.0|<|0.0001|TWO_SIDED|95.0|51.0|110.0||No adjustment of the significance level (0.05) was done as a hierarchical approach for hypotheses testing was used.|ANCOVA|Repeated measurements analysis (change from baseline over 24 weeks of treatment taking all post-randomization measurements into account).||||110|51|<0.0001
72340241|NCT00424268|144204146|SUPERIORITY_OR_OTHER||Mean Difference (Net)|81.0|STANDARD_ERROR_OF_MEAN|15.0|<|0.0001|TWO_SIDED|95.0|51.0|110.0||No adjustment of the significance level (0.05) was done as a hierarchical approach for hypotheses testing was used.|ANCOVA|Repeated measurements analysis (change from baseline over 24 weeks of treatment taking all post-randomization measurements into account).||||110|51|<0.0001
72340242|NCT00424268|144204147|SUPERIORITY_OR_OTHER||Rate ratio|0.768|STANDARD_ERROR_OF_MEAN|0.157||0.1957|TWO_SIDED|95.0|0.515|1.146||No adjustment of the significance level (0.05) was done as a hierarchical approach for hypotheses testing was used.|Poisson regression|||||1.146|0.515|0.1957
72340243|NCT00424268|144204148|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.4|STANDARD_ERROR_OF_MEAN|0.1||0.0032|TWO_SIDED|95.0|0.1|0.7||This secondary endpoint was analyzed in an exploratory manner.|ANCOVA|Repeated measurements analysis (change from baseline over 24 weeks of treatment taking all post-randomization measurements into account).||||0.7|0.1|0.0032
72340244|NCT00424268|144204149|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.6|STANDARD_ERROR_OF_MEAN|0.9||0.0051|TWO_SIDED|95.0|-4.5|-0.8||This secondary endpoint was analyzed in an exploratory manner.|ANCOVA|Repeated measurements analysis (change from baseline over 24 weeks of treatment taking all post-randomization measurements into account).||||-0.8|-4.5|0.0051
72340245|NCT01378429|144204150|NON_INFERIORITY_OR_EQUIVALENCE|35 subjects per arm would have ≥90% power to demonstrate that the upper bound of a two-sided 95% confidence interval (equivalent to the upper bound of a one-sided 97.5% confidence interval) of the difference of placebo minus ciclesonide nasal aerosol would be less than 20% of the baseline value of 175 mcg•h/dL or a noninferiority limit of 35 mcg•h/dL assuming a SD of 40 and a one-sided α of 0.025. A total of 40 subjects will be randomly assigned to ensure 35 subjects complete the study per arm.|LS Mean Difference|7.6|||||TWO_SIDED|95.0|-7.4|22.6||\<0.025 for a one-sided test.|ANCOVA||Difference is calculated as Placebo - Ciclesonide.|35 subjects per arm would have ≥90% power to demonstrate that the upper bound of a two-sided 95% confidence interval (equivalent to the upper bound of a one-sided 97.5% confidence interval) of the difference of placebo minus ciclesonide nasal aerosol would be less than 20% of the baseline value of 175 mcg•h/dL or a noninferiority limit of 35 mcg•h/dL assuming a SD of 40 and a one-sided α of 0.025. A total of 40 subjects will be randomly assigned to ensure 35 subjects complete the study per arm.||22.6|-7.4|
72370026|NCT00856518|144250527|SUPERIORITY_OR_OTHER|||||||0.022|||||||Plum Ordinal Regression test|EMST arm vs. Sham arm group comparison of treatment response in Pharyngeal domain||||||0.022
72370027|NCT00856518|144250527|SUPERIORITY_OR_OTHER||||||>|0.05||||||Sham arm post vs. pre-treatment comparison for the total SWAL-QOL score and subscale scores except for the Burden and Mental Health domains.|Wilcoxon Signed Ranks Test|||||||>0.05
72370028|NCT00856518|144250527|SUPERIORITY_OR_OTHER|||||||0.038|||||||Wilcoxon Signed Ranks Test|Sham arm post vs. pre-treatment comparison in Burden domain||||||0.038
72370029|NCT00856518|144250527|SUPERIORITY_OR_OTHER|||||||0.031|||||||Wilcoxon Signed Ranks Test|Sham arm post vs. pre-treatment comparison in Mental Health domain||||||0.031
72340246|NCT01018095|144204167|NON_INFERIORITY_OR_EQUIVALENCE|Continuous variables were assessed for normality, and tested accordingly. When appropriate, continuous variables were categorized using clinically relevant cut-points. Categorical variables were compared using the Chi-square test. The measure of association at TOC was calculated as a relative risk with 95% confidence interval.|Risk Ratio (RR)|0.5|STANDARD_ERROR_OF_MEAN|0.191||0.045|TWO_SIDED|95.0|0.25|1.0|||Relative risk|The measure of association at TOC and 3 months was calculated as a relative risk with 95% confidence interval.||It was initially estimated that a total of 380 participants (190 per arm) would be required, with 90% power and a significance level of 5%, to establish equivalency between the two treatment arms.31 Enrollment rates were lower than estimated and only 270 participants (135 per arm) were enrolled.||1.00|0.25|.045
72340247|NCT01018095|144204167|NON_INFERIORITY_OR_EQUIVALENCE|It was initially estimated that a total of 380 participants (190 per arm) would be required, with 90% power and a significance level of 5%, to establish equivalency between the two treatment arms.|Risk Ratio (RR)|0.46|STANDARD_DEVIATION|1.0|<|0.05|TWO_SIDED|95.0|0.21|0.98||Continuous variables were assessed for normality, and tested accordingly. When appropriate, continuous variables were categorized using clinically relevant cut-points. Categorical variables were compared using the Chi-square test.|Chi-squared|||||0.98|0.21|<0.05
72340248|NCT01018095|144204168|NON_INFERIORITY_OR_EQUIVALENCE|Continuous variables were assessed for normality, and tested accordingly. When appropriate, continuous variables were categorized using clinically relevant cut-points. Categorical variables were compared using the Chi-square test. The measure of association at 3 months was calculated as a relative risk with 95% confidence interval.|Risk Ratio (RR)|0.46|STANDARD_ERROR_OF_MEAN|0.196|=|0.03|TWO_SIDED|95.0|0.21|0.98|||Relative risk|The measure of association at TOC and 3 months was calculated as a relative risk with 95% confidence interval.||It was initially estimated that a total of 380 participants (190 per arm) would be required, with 90% power and a significance level of 5%, to establish equivalency between the two treatment arms.31 Enrollment rates were lower than estimated and only 270 participants (135 per arm) were enrolled.||0.98|.21|=0.03
72340249|NCT04075409|144204232|OTHER||LS means ratio|1.426|||||TWO_SIDED|90.0|1.112|1.83|||ANOVA|The ANOVA model included genotype group as the fixed effects. The natural logs were taken of the dependent variables and were back-transformed.||Point estimates for the geometric least squares (LS) means ratio and the respective 2-sided 90% Confidence Intervals (CIs) were computed using the LS means and the root mean squares of error, based on of the log-transformed data with subsequent exponential transformation.||1.830|1.112|
72340250|NCT04075409|144204232|OTHER||LS means ratio|1.234|||||TWO_SIDED|90.0|0.9619|1.584|||ANOVA|The ANOVA model included genotype group as the fixed effects. The natural logs were taken of the dependent variables and were back-transformed.||Point estimates for the geometric least squares (LS) means ratio and the respective 2-sided 90% CIs were computed using the LS means and the root mean squares of error, based on of the log-transformed data with subsequent exponential transformation.||1.584|0.9619|
72340251|NCT04075409|144204232|OTHER||LS means ratio|1.156|||||TWO_SIDED|90.0|0.9008|1.483|||ANOVA|The ANOVA model included genotype group as the fixed effects. The natural logs were taken of the dependent variables and were back-transformed.||Point estimates for the geometric least squares (LS) means ratio and the respective 2-sided 90% CIs were computed using the LS means and the root mean squares of error, based on of the log-transformed data with subsequent exponential transformation.||1.483|0.9008|
72340252|NCT04075409|144204233|OTHER||LS means ratio|2.122|||||TWO_SIDED|90.0|1.706|2.638|||ANOVA|The ANOVA model included genotype group as the fixed effects. The natural logs were taken of the dependent variables and were back-transformed.||Point estimates for the geometric least squares (LS) means ratio and the respective 2-sided 90% CIs were computed using the LS means and the root mean squares of error, based on of the log-transformed data with subsequent exponential transformation.||2.638|1.706|
72340253|NCT04075409|144204233|OTHER||LS means ratio|1.289|||||TWO_SIDED|90.0|1.037|1.603|||ANOVA|The ANOVA model included genotype group as the fixed effects. The natural logs were taken of the dependent variables and were back-transformed.||Point estimates for the geometric least squares (LS) means ratio and the respective 2-sided 90% CIs were computed using the LS means and the root mean squares of error, based on of the log-transformed data with subsequent exponential transformation.||1.603|1.037|
72340254|NCT04075409|144204233|OTHER||LS means ratio|1.646|||||TWO_SIDED|90.0|1.323|2.046|||ANOVA|The ANOVA model included genotype group as the fixed effects. The natural logs were taken of the dependent variables and were back-transformed.||Point estimates for the geometric least squares (LS) means ratio and the respective 2-sided 90% CIs were computed using the LS means and the root mean squares of error, based on of the log-transformed data with subsequent exponential transformation.||2.046|1.323|
72340255|NCT04075409|144204234|OTHER||LS means ratio|2.124|||||TWO_SIDED|90.0|1.709|2.639|||ANOVA|The ANOVA model included genotype group as the fixed effects. The natural logs were taken of the dependent variables and were back-transformed.||Point estimates for the geometric least squares (LS) means ratio and the respective 2-sided 90% CIs were computed using the LS means and the root mean squares of error, based on of the log-transformed data with subsequent exponential transformation.||2.639|1.709|
72340256|NCT04075409|144204234|OTHER||LS means ratio|1.291|||||TWO_SIDED|90.0|1.039|1.604|||ANOVA|The ANOVA model included genotype group as the fixed effects. The natural logs were taken of the dependent variables and were back-transformed.||Point estimates for the geometric least squares (LS) means ratio and the respective 2-sided 90% CIs were computed using the LS means and the root mean squares of error, based on of the log-transformed data with subsequent exponential transformation.||1.604|1.039|
72340257|NCT04075409|144204234|OTHER||LS means ratio|1.645|||||TWO_SIDED|90.0|1.324|2.044|||ANOVA|The ANOVA model included genotype group as the fixed effects. The natural logs were taken of the dependent variables and were back-transformed.||Point estimates for the geometric least squares (LS) means ratio and the respective 2-sided 90% CIs were computed using the LS means and the root mean squares of error, based on of the log-transformed data with subsequent exponential transformation.||2.044|1.324|
72340258|NCT04075409|144204237|OTHER||LS means ratio|1.089|||||TWO_SIDED|90.0|0.8859|1.339|||ANOVA|The ANOVA model included genotype group as the fixed effects. The natural logs were taken of the dependent variables and were back-transformed.||Point estimates for the geometric least squares (LS) means ratio and the respective 2-sided 90% CIs were computed using the LS means and the root mean squares of error, based on of the log-transformed data with subsequent exponential transformation.||1.339|0.8859|
72370030|NCT00856518|144250527|SUPERIORITY_OR_OTHER|||||||0.027|||||||Wilcoxon Signed Ranks Test|EMST arm post vs. pre-treatment comparison in Burden domain||||||0.027
72340259|NCT04075409|144204237|OTHER||LS means ratio|1.044|||||TWO_SIDED|90.0|0.8489|1.283|||ANOVA|The ANOVA model included genotype group as the fixed effects. The natural logs were taken of the dependent variables and were back-transformed.||Point estimates for the geometric least squares (LS) means ratio and the respective 2-sided 90% CIs were computed using the LS means and the root mean squares of error, based on of the log-transformed data with subsequent exponential transformation.||1.283|0.8489|
72340260|NCT04075409|144204237|OTHER||LS means ratio|1.044|||||TWO_SIDED|90.0|0.8489|1.283|||ANOVA|The ANOVA model included genotype group as the fixed effects. The natural logs were taken of the dependent variables and were back-transformed.||Point estimates for the geometric least squares (LS) means ratio and the respective 2-sided 90% CIs were computed using the LS means and the root mean squares of error, based on of the log-transformed data with subsequent exponential transformation.||1.283|0.8489|
72340261|NCT04075409|144204238|OTHER||LS means ratio|1.344|||||TWO_SIDED|90.0|1.092|1.653|||ANOVA|The ANOVA model included genotype group as the fixed effects. The natural logs were taken of the dependent variables and were back-transformed.||Point estimates for the geometric least squares (LS) means ratio and the respective 2-sided 90% CIs were computed using the LS means and the root mean squares of error, based on of the log-transformed data with subsequent exponential transformation.||1.653|1.092|
72340262|NCT04075409|144204238|OTHER||LS means ratio|0.9991|||||TWO_SIDED|90.0|0.812|1.229|||ANOVA|The ANOVA model included genotype group as the fixed effects. The natural logs were taken of the dependent variables and were back-transformed.||Point estimates for the geometric least squares (LS) means ratio and the respective 2-sided 90% CIs were computed using the LS means and the root mean squares of error, based on of the log-transformed data with subsequent exponential transformation.||1.229|0.8120|
72340263|NCT04075409|144204238|OTHER||LS means ratio|1.345|||||TWO_SIDED|90.0|1.093|1.655|||ANOVA|The ANOVA model included genotype group as the fixed effects. The natural logs were taken of the dependent variables and were back-transformed.||Point estimates for the geometric least squares (LS) means ratio and the respective 2-sided 90% CIs were computed using the LS means and the root mean squares of error, based on of the log-transformed data with subsequent exponential transformation.||1.655|1.093|
72340264|NCT01595581|144204256|OTHER|Mann-Whitney U test for continuous variables and Fisher exact test for categorical variables|Mean Difference (Net)|2.9|STANDARD_DEVIATION|1.5||0.35|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||"Power was estimated for change in lean mass of 3.0 plus or minus 1.5 kg in healthy men receiving testosterone. Using a significance level of 0.05 and a power of 0.80, a sample size of 6 participants per group was calculated.~This statistical analysis applies to lean mass in participants 6 weeks post operative."||||0.35
72340265|NCT01595581|144204256|OTHER||Mean Difference (Net)|2.17|STANDARD_DEVIATION|2.0||0.48|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||"Power was estimated for change in lean mass of 3.0 plus or minus 1.5 kg in healthy men receiving testosterone. Using a significance level of 0.05 and a power of 0.80, a sample size of 6 participants per group was calculated.~This statistical analysis applies to lean mass in participants 12 weeks post operative."||||0.48
72340266|NCT01595581|144204256|OTHER||Mean Difference (Net)|1.08|STANDARD_DEVIATION|15.0||0.74|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||"Power was estimated for change in lean mass of 3.0 plus or minus 1.5 kg in healthy men receiving testosterone. Using a significance level of 0.05 and a power of 0.80, a sample size of 6 participants per group was calculated.~This statistical analysis applies to lean mass in participants 24 weeks post operative."||||0.74
72340267|NCT01058941|144204273|OTHER||Mean Difference (Net)|-0.42||||0.82|TWO_SIDED|95.0|-3.97|3.13||We used a significance level of p = 0.025 for our measure of ADL changes based on a simple Bonferroni adjustment since we have two primary outcomes.|Mixed Models Analysis|Adjusted for baseline outcome, time from baseline, age, education category, BMI, cholinesterase inhibitors, memantine, vitamin E, and Apo-E.||The target enrollment was 60 subjects, allowing for up to a 20% drop-out. It was calculated that with 48 subjects (24 per group) we would have 80% power to see differences in ADL scores over 18 months between the treatment and placebo groups with a significance level of 0.025 based on a simple Bonferroni adjustment, since we had two primary outcomes.||3.13|-3.97|0.82
72340268|NCT01058941|144204274|OTHER||Mean Difference (Net)|-3.68||||0.001|TWO_SIDED|95.0|-5.9|-1.46||We used a significance level of p = 0.025 for our measure of ADAS-cog changes based on a simple Bonferroni adjustment since we have two primary outcomes.|Mixed Models Analysis|Adjusted for baseline outcome, time from baseline, age, education category, BMI, cholinesterase inhibitors, memantine, vitamin E, and Apo-E.||The target enrollment was 60 subjects, allowing for up to a 20% drop-out. It was calculated that with 48 subjects (24 per group) we would have 80% power to see differences in ADL scores over 18 months between the treatment and placebo groups with a significance level of 0.025 based on a simple Bonferroni adjustment, since we had two primary outcomes.||-1.46|-5.90|0.001
72340269|NCT01274611|144204283|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|A sample of 20 patients, or 40 treatment sites (the unit of randomization), provided 80% power to detect effect sizes of 0.68 using a paired t test at a type I error rate of 5%.|Mean Difference (Net)|0.8|||<|0.01|||||||t-test, 2 sided|||||||<0.01
72340270|NCT01274611|144204284|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|A sample of 20 patients, or 40 treatment sites (the unit of randomization), provided 80% power to detect effect sizes of 0.68 using a paired t test at a type I error rate of 5%.|Mean Difference (Net)|15.0|||>|0.01|||||||t-test, 2 sided|||||||>0.01
72340271|NCT03449433|144204292|SUPERIORITY||Ratio of LS Means|1.04|||||TWO_SIDED|95.0|0.985|1.1||||||||1.10|0.985|
72340272|NCT02739321|144204297|NON_INFERIORITY|Hypothesized benchmark of 30%|Risk Difference (RD)|25.6|||<|0.001|TWO_SIDED||||||t-test, 2 sided|||||||<.001
72340273|NCT02739321|144204298|SUPERIORITY|||||||0.001|||||||Mixed Models Analysis|||||||.001
72340274|NCT02739321|144204299|SUPERIORITY||Mean Difference (Final Values)|0.12||||0.001|TWO_SIDED||||||Mixed Models Analysis|||||||0.001
72340275|NCT02739321|144204300|SUPERIORITY||Median Difference (Final Values)|4.09||||0.268|TWO_SIDED||||||Mixed Models Analysis|||||||.268
72340276|NCT02739321|144204301|SUPERIORITY||Mean Difference (Final Values)|0.94||||0.058|TWO_SIDED||||||Mixed Models Analysis|||||||.058
72340277|NCT02739321|144204302|SUPERIORITY||Mean Difference (Final Values)|2.82||||0.001|TWO_SIDED||||||Mixed Models Analysis|||||||.001
72340278|NCT02739321|144204303|SUPERIORITY|||||||0.232|||||||Mixed Models Analysis|||||||.232
72340279|NCT02739321|144204304|SUPERIORITY|||||||0.1|||||||Mixed Models Analysis|||||||0.100
72340280|NCT02739321|144204305|SUPERIORITY|||||||0.285|||||||Mixed Models Analysis|||||||0.285
72340281|NCT02739321|144204306|SUPERIORITY|||||||0.089|||||||Mixed Models Analysis|||||||0.089
72340282|NCT02739321|144204307|SUPERIORITY|||||||0.04|||||||Mixed Models Analysis|||||||0.040
72340283|NCT02739321|144204308|SUPERIORITY|||||||0.471|||||||Mixed Models Analysis|||||||0.471
72340284|NCT02739321|144204309|SUPERIORITY|||||||0.015|||||||Mixed Models Analysis|||||||0.015
72340285|NCT02739321|144204310|SUPERIORITY|||||||0.001|||||||Mixed Models Analysis|||||||0.001
72340286|NCT02739321|144204311|NON_INFERIORITY|Non-inferiority compared to the median rating of four on the seven point scale (1 = extremely poor, 7 = exceptional) that was used to rate tolerance.|||||||||||||||||The mean rating of parent reported tolerance of mattress technology was 5.61 (SE = 0.25).|||
72340287|NCT02739321|144204312|NON_INFERIORITY|Non-inferiority compared to the median rating of four on the seven point scale (1 = extremely poor, 7 = exceptional) that was used to rate tolerance.|||||||||||||||||The mean rating of parent reported tolerance of actigraph watch was 5.51 (SE = 0.13).|||
72340288|NCT02739321|144204313|NON_INFERIORITY|Non-inferiority compared to the median rating of four on the seven point scale (1 = extremely difficult, 7 = extremely easy) that was used to rate ease of use.|||||||||||||||||The mean rating of parent reported ease of us of the mattress technology was 6.04 (SE = 0.15).|||
72340289|NCT02739321|144204314|SUPERIORITY||Mean Difference (Final Values)|0.51||||0.001|TWO_SIDED||||||Mixed Models Analysis|||||||.001
72340290|NCT01345682|144204317|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.792||||0.0257|TWO_SIDED|95.0|0.643|0.977||Log-rank test stratified by baseline Eastern Cooperative Oncology Group (ECOG) Performance score (PS)(0 or 1) and prior use of Epidermal Growth Factor Receptor (EGFR)-targeted antibody in the Recurrent and/or Metastatic (R/M) setting (Yes or No).|Stratified Log-rank test||"Hazard ratio from Cox proportional hazards model stratified by baseline ECOG PS (0 or 1) and prior use of EGFR-targeted antibody in the R/M setting (Yes or No).~Afatinib (BIBW 2992) vs Methotrexate"|||0.977|0.643|0.0257
72340291|NCT01345682|144204318|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.958||||0.6755|TWO_SIDED|95.0|0.786|1.169||Log-rank test stratified by baseline ECOG PS (0 or 1) and prior use of EGFR-targeted antibody in the R/M setting (Yes or No).|Stratified Log-rank test||"Hazard ratio from Cox proportional hazards model stratified by baseline ECOG PS (0 or 1) and prior use of EGFR-targeted antibody in the R/M setting (Yes or No).~Afatinib (BIBW 2992) vs Methotrexate"|||1.169|0.786|0.6755
72340292|NCT01345682|144204319|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.91||||0.101|TWO_SIDED|95.0|0.88|4.14|||Regression, Logistic||"Odds ratio, 95% Confidence Interval (CI) and p-value (two-sided) from logistic regression stratified by baseline ECOG PS (0 or 1) and prior use of EGFR-targeted antibody in the R/M setting (Yes or No).~Afatinib (BIBW 2992) vs Methotrexate"|||4.14|0.88|0.1010
72340293|NCT01345682|144204320|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.52||||0.0353|TWO_SIDED|95.0|1.03|2.26|||Regression, Logistic||"Odds ratio, 95% CI and p-value (two-sided) from logistic regression stratified by baseline ECOG PS (0 or 1) and prior use of EGFR-targeted antibody in the R/M setting (Yes or No).~Afatinib (BIBW 2992) vs Methotrexate"|||2.26|1.03|0.0353
72340294|NCT01345682|144204322|SUPERIORITY_OR_OTHER||Adjusted mean difference|-4.4|STANDARD_ERROR_OF_MEAN|2.01||0.03|TWO_SIDED|95.0|-8.31|-0.42||Adjusted for baseline ECOG performance score (0 or 1) and prior use of EGFR-targeted antibody for R/M HNSCC (Yes or No).|longitudinal models||Afatinib (BIBW 2992) vs Methotrexate|Changes in scores over time were assessed using longitudinal models, i.e. mixed effects growth curve models with the average profile over time for each endpoint described by a piecewise linear model adjusted for the fixed effects baseline ECOG performance score (PS) and prior use of EGFR-targeted antibody for recurrent and/or metastatic head and neck squamous cell carcinoma (R/M HNSCC).||-0.42|-8.31|0.0300
72428398|NCT01327547|144367749|SUPERIORITY_OR_OTHER||Difference in LS mean|0.0||||0.9991|TWO_SIDED|95.0|-0.1|0.1|||ANCOVA||Difference in LS Mean|Results are from an ANCOVA model with change from baseline at Week 96 as the response variable and the following fixed effect model terms: treatment (Maraviroc or placebo), baseline value of the response variable, HBV, PI-based regimen.||0.10|-0.10|0.9991
72340295|NCT01345682|144204323|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.1|STANDARD_ERROR_OF_MEAN|2.16||0.9773|TWO_SIDED|95.0|-4.3|4.18||Adjusted for baseline ECOG performance score (0 or 1) and prior use of EGFR-targeted antibody for R/M HNSCC (Yes or No).|longitudinal models||Afatinib (BIBW 2992) vs Methotrexate|Changes in scores over time were assessed using longitudinal models, i.e. mixed effects growth curve models with the average profile over time for each endpoint described by a piecewise linear model adjusted for the fixed effects baseline ECOG PS and prior use of EGFR-targeted antibody for recurrent and/or metastatic head and neck squamous cell carcinoma (R/M HNSCC).||4.18|-4.30|0.9773
72340296|NCT01345682|144204324|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.6|STANDARD_ERROR_OF_MEAN|1.95||0.7767|TWO_SIDED|95.0|-3.28|4.39||Adjusted for baseline ECOG performance score (0 or 1) and prior use of EGFR-targeted antibody for R/M HNSCC (Yes or No).|longitudinal models||Afatinib (BIBW 2992) vs Methotrexate|Changes in scores over time were assessed using longitudinal models, i.e. mixed effects growth curve models with the average profile over time for each endpoint described by a piecewise linear model adjusted for the fixed effects baseline ECOG PS and prior use of EGFR-targeted antibody for recurrent and/or metastatic head and neck squamous cell carcinoma (R/M HNSCC).||4.39|-3.28|0.7767
72340297|NCT01345682|144204325|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.19||||0.494|TWO_SIDED|95.0|0.717|1.99|||Regression, Logistic||Odds ratio, 95% CI and p-value (two-sided) from logistic regression stratified by baseline ECOG PS (0 or 1) and prior use of EGFR-targeted antibody in the R/M setting (Yes or No). Afatinib (BIBW 2992) vs Methotrexate|||1.990|0.717|0.494
72340298|NCT01345682|144204326|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.16||||0.584|TWO_SIDED|95.0|0.687|1.95|||Regression, Logistic||Odds ratio, 95% CI and p-value (two-sided) from logistic regression stratified by baseline ECOG PS (0 or 1) and prior use of EGFR-targeted antibody in the R/M setting (Yes or No). Afatinib (BIBW 2992) vs Methotrexate|||1.950|0.687|0.584
72340299|NCT01345682|144204327|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.06||||0.816|TWO_SIDED|95.0|0.657|1.705|||Regression, Logistic||Odds ratio, 95% CI and p-value (two-sided) from logistic regression stratified by baseline ECOG PS (0 or 1) and prior use of EGFR-targeted antibody in the R/M setting (Yes or No). Afatinib (BIBW 2992) vs Methotrexate|||1.705|0.657|0.816
72340300|NCT01345682|144204328|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.73||||0.0217|TWO_SIDED|95.0|0.55|0.96||Log-rank test stratified by baseline ECOG PS (0 or 1) and prior use of EGFR-targeted antibody in the R/M setting (Yes or No).|Stratified Log-rank test||Hazard ratio from Cox proportional hazards model stratified by baseline ECOG PS (0 or 1) and prior use of EGFR-targeted antibody in the R/M setting (Yes or No).|||0.96|0.55|0.0217
72340301|NCT01345682|144204329|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.67||||0.004|TWO_SIDED|95.0|0.5|0.89||Log-rank test stratified by baseline ECOG PS (0 or 1) and prior use of EGFR-targeted antibody in the R/M setting (Yes or No).|Stratified Log-rank test||"Hazard ratio from Cox proportional hazards model stratified by baseline ECOG PS (0 or 1) and prior use of EGFR-targeted antibody in the R/M setting (Yes or No).~Afatinib (BIBW 2992) vs Methotrexate"|||0.89|0.50|0.0040
72340302|NCT01345682|144204330|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.74||||0.0268|TWO_SIDED|95.0|0.56|0.97||Log-rank test stratified by baseline ECOG PS (0 or 1) and prior use of EGFR-targeted antibody in the R/M setting (Yes or No).|Stratified Log-rank test||"Hazard ratio from Cox proportional hazards model stratified by baseline ECOG PS (0 or 1) and prior use of EGFR-targeted antibody in the R/M setting (Yes or No).~Afatinib (BIBW 2992) vs Methotrexate"|||0.97|0.56|0.0268
72340303|NCT00897390|144204334|NON_INFERIORITY_OR_EQUIVALENCE|Point estimates and 90% confidence intervals were calculated for the Arm B to Arm A and Arm D to Arm C ratios of geometric means for Cmax, AUC(INF) and AUC(0-T) of saxagliptin and metformin, respectively. Potency-corrected results were also provided. Bioequivalence will be concluded if the 90% confidence intervals for the test-to-reference ratios of geometric means are entirely contained within 80% to 125% for both Cmax and AUC(INF). No adjustments were made for multiplicity.|adjusted geometric mean|1.042|||||TWO_SIDED|90.0|1.009|1.075||||||To demonstrate the bioequivalence of formulation (FDC tablet versus co-administration of separate saxagliptin tablet and metformin IR tablet) in the fasted and fed state, linear mixed model analyses were performed on log(Cmax), log\[AUC(INF)\] and log\[AUC(0-T)\] of saxagliptin and metformin, respectively. The factors in the model were sequence, period and treatment as fixed effects and subject within sequence as a random effect.||1.075|1.009|
72340304|NCT00897390|144204334|NON_INFERIORITY_OR_EQUIVALENCE|Point estimates and 90% confidence intervals were calculated for the Arm B to Arm A and Arm D to Arm C ratios of geometric means for Cmax, AUC(INF) and AUC(0-T) of saxagliptin and metformin, respectively. Potency-corrected results were also provided. Bioequivalence will be concluded if the 90% confidence intervals for the test-to-reference ratios of geometric means are entirely contained within 80% to 125% for both Cmax and AUC(INF). No adjustments were made for multiplicity.|adjusted geometric mean|0.988|||||TWO_SIDED|90.0|0.958|1.019||||||To demonstrate the bioequivalence of formulation (FDC tablet versus co-administration of separate saxagliptin tablet and metformin IR tablet) in the fasted and fed state, linear mixed model analyses were performed on log(Cmax), log\[AUC(INF)\] and log\[AUC(0-T)\] of saxagliptin and metformin, respectively. The factors in the model were sequence, period and treatment as fixed effects and subject within sequence as a random effect.||1.019|0.958|
72340305|NCT00897390|144204336|NON_INFERIORITY_OR_EQUIVALENCE|Point estimates and 90% confidence intervals were calculated for the Arm B to Arm A and Arm D to Arm C ratios of geometric means for Cmax, AUC(INF) and AUC(0-T) of saxagliptin and metformin, respectively. Potency-corrected results were also provided. Bioequivalence will be concluded if the 90% confidence intervals for the test-to-reference ratios of geometric means are entirely contained within 80% to 125% for both Cmax and AUC(INF). No adjustments were made for multiplicity.|adjusted geometric mean|1.045|||||TWO_SIDED|90.0|1.013|1.077||||||To demonstrate the bioequivalence of formulation (FDC tablet versus co-administration of separate saxagliptin tablet and metformin IR tablet) in the fasted and fed state, linear mixed model analyses were performed on log(Cmax), log\[AUC(INF)\] and log\[AUC(0-T)\] of saxagliptin and metformin, respectively. The factors in the model were sequence, period and treatment as fixed effects and subject within sequence as a random effect.||1.077|1.013|
72340306|NCT00897390|144204336|NON_INFERIORITY_OR_EQUIVALENCE|Point estimates and 90% confidence intervals were calculated for the Arm B to Arm A and Arm D to Arm C ratios of geometric means for Cmax, AUC(INF) and AUC(0-T) of saxagliptin and metformin, respectively. Potency-corrected results were also provided. Bioequivalence will be concluded if the 90% confidence intervals for the test-to-reference ratios of geometric means are entirely contained within 80% to 125% for both Cmax and AUC(INF). No adjustments were made for multiplicity.|adjusted geometric mean|0.992|||||TWO_SIDED|90.0|0.962|1.022||||||To demonstrate the bioequivalence of formulation (FDC tablet versus co-administration of separate saxagliptin tablet and metformin IR tablet) in the fasted and fed state, linear mixed model analyses were performed on log(Cmax), log\[AUC(INF)\] and log\[AUC(0-T)\] of saxagliptin and metformin, respectively. The factors in the model were sequence, period and treatment as fixed effects and subject within sequence as a random effect.||1.022|0.962|
72340307|NCT00897390|144204337|NON_INFERIORITY_OR_EQUIVALENCE|Point estimates and 90% confidence intervals were calculated for the Arm B to Arm A and Arm D to Arm C ratios of geometric means for Cmax, AUC(INF) and AUC(0-T) of saxagliptin and metformin, respectively. Potency-corrected results were also provided. Bioequivalence will be concluded if the 90% confidence intervals for the test-to-reference ratios of geometric means are entirely contained within 80% to 125% for both Cmax and AUC(INF). No adjustments were made for multiplicity.|adjusted geometric mean|1.077|||||TWO_SIDED|90.0|0.978|1.185||||||To demonstrate the bioequivalence of formulation (FDC tablet versus co-administration of separate saxagliptin tablet and metformin IR tablet) in the fasted and fed state, linear mixed model analyses were performed on log(Cmax), log\[AUC(INF)\] and log\[AUC(0-T)\] of saxagliptin and metformin, respectively. The factors in the model were sequence, period and treatment as fixed effects and subject within sequence as a random effect.||1.185|0.978|
72340308|NCT00897390|144204337|NON_INFERIORITY_OR_EQUIVALENCE|Point estimates and 90% confidence intervals were calculated for the Arm B to Arm A and Arm D to Arm C ratios of geometric means for Cmax, AUC(INF) and AUC(0-T) of saxagliptin and metformin, respectively. Potency-corrected results were also provided. Bioequivalence will be concluded if the 90% confidence intervals for the test-to-reference ratios of geometric means are entirely contained within 80% to 125% for both Cmax and AUC(INF). No adjustments were made for multiplicity.|adjusted geometric mean|0.987|||||TWO_SIDED|90.0|0.9|1.083||||||To demonstrate the bioequivalence of formulation (FDC tablet versus co-administration of separate saxagliptin tablet and metformin IR tablet) in the fasted and fed state, linear mixed model analyses were performed on log(Cmax), log\[AUC(INF)\] and log\[AUC(0-T)\] of saxagliptin and metformin, respectively. The factors in the model were sequence, period and treatment as fixed effects and subject within sequence as a random effect.||1.083|0.900|
72370031|NCT00856518|144250527|SUPERIORITY_OR_OTHER|||||||0.016|||||||Wilcoxon Signed Ranks Test|EMST arm post vs. pre-treatment comparison in Mental Health domain||||||0.016
72370032|NCT00856518|144250527|SUPERIORITY_OR_OTHER|||||||0.007|||||||Wilcoxon Signed Ranks Test|EMST arm post vs. pre-treatment comparison in Pharyngeal domain||||||0.007
72370033|NCT00856518|144250527|SUPERIORITY_OR_OTHER|||||||0.036|||||||Wilcoxon Signed Ranks Test|EMST arm post vs. pre-treatment comparison in Saliva domain||||||0.036
72340309|NCT00897390|144204340|NON_INFERIORITY_OR_EQUIVALENCE|Point estimates and 90% confidence intervals were calculated for the Arm B to Arm A and Arm D to Arm C ratios of geometric means for Cmax, AUC(INF) and AUC(0-T) of saxagliptin and metformin, respectively. Potency-corrected results were also provided. Bioequivalence will be concluded if the 90% confidence intervals for the test-to-reference ratios of geometric means are entirely contained within 80% to 125% for both Cmax and AUC(INF). No adjustments were made for multiplicity.|adjusted geometric mean|0.974|||||TWO_SIDED|90.0|0.921|1.03||||||To demonstrate the bioequivalence of formulation (FDC tablet versus co-administration of separate saxagliptin tablet and metformin IR tablet) in the fasted and fed state, linear mixed model analyses were performed on log(Cmax), log\[AUC(INF)\] and log\[AUC(0-T)\] of saxagliptin and metformin, respectively. The factors in the model were sequence, period and treatment as fixed effects and subject within sequence as a random effect.||1.030|0.921|
72340310|NCT00897390|144204340|NON_INFERIORITY_OR_EQUIVALENCE|Point estimates and 90% confidence intervals were calculated for the Arm B to Arm A and Arm D to Arm C ratios of geometric means for Cmax, AUC(INF) and AUC(0-T) of saxagliptin and metformin, respectively. Potency-corrected results were also provided. Bioequivalence will be concluded if the 90% confidence intervals for the test-to-reference ratios of geometric means are entirely contained within 80% to 125% for both Cmax and AUC(INF). No adjustments were made for multiplicity.|adjusted geometric mean|0.966||||||90.0|0.915|1.02||||||To demonstrate the bioequivalence of formulation (FDC tablet versus co-administration of separate saxagliptin tablet and metformin IR tablet) in the fasted and fed state, linear mixed model analyses were performed on log(Cmax), log\[AUC(INF)\] and log\[AUC(0-T)\] of saxagliptin and metformin, respectively. The factors in the model were sequence, period and treatment as fixed effects and subject within sequence as a random effect.||1.020|0.915|
72340311|NCT00897390|144204341|NON_INFERIORITY_OR_EQUIVALENCE|Point estimates and 90% confidence intervals were calculated for the Arm B to Arm A and Arm D to Arm C ratios of geometric means for Cmax, AUC(INF) and AUC(0-T) of saxagliptin and metformin, respectively. Potency-corrected results were also provided. Bioequivalence will be concluded if the 90% confidence intervals for the test-to-reference ratios of geometric means are entirely contained within 80% to 125% for both Cmax and AUC(INF). No adjustments were made for multiplicity.|adjusted geometric mean|0.962||||||90.0|0.906|1.02||||||To demonstrate the bioequivalence of formulation (FDC tablet versus co-administration of separate saxagliptin tablet and metformin IR tablet) in the fasted and fed state, linear mixed model analyses were performed on log(Cmax), log\[AUC(INF)\] and log\[AUC(0-T)\] of saxagliptin and metformin, respectively. The factors in the model were sequence, period and treatment as fixed effects and subject within sequence as a random effect.||1.020|0.906|
72340312|NCT00897390|144204341|NON_INFERIORITY_OR_EQUIVALENCE|Point estimates and 90% confidence intervals were calculated for the Arm B to Arm A and Arm D to Arm C ratios of geometric means for Cmax, AUC(INF) and AUC(0-T) of saxagliptin and metformin, respectively. Potency-corrected results were also provided. Bioequivalence will be concluded if the 90% confidence intervals for the test-to-reference ratios of geometric means are entirely contained within 80% to 125% for both Cmax and AUC(INF). No adjustments were made for multiplicity.|adjusted geometric mean|0.974||||||90.0|0.92|1.032||||||To demonstrate the bioequivalence of formulation (FDC tablet versus co-administration of separate saxagliptin tablet and metformin IR tablet) in the fasted and fed state, linear mixed model analyses were performed on log(Cmax), log\[AUC(INF)\] and log\[AUC(0-T)\] of saxagliptin and metformin, respectively. The factors in the model were sequence, period and treatment as fixed effects and subject within sequence as a random effect.||1.032|0.920|
72340313|NCT00897390|144204342|NON_INFERIORITY_OR_EQUIVALENCE|Point estimates and 90% confidence intervals were calculated for the Arm B to Arm A and Arm D to Arm C ratios of geometric means for Cmax, AUC(INF) and AUC(0-T) of saxagliptin and metformin, respectively. Potency-corrected results were also provided. Bioequivalence will be concluded if the 90% confidence intervals for the test-to-reference ratios of geometric means are entirely contained within 80% to 125% for both Cmax and AUC(INF). No adjustments were made for multiplicity.|adjusted geometric mean|0.937|||||TWO_SIDED|90.0|0.864|1.016||||||To demonstrate the bioequivalence of formulation (FDC tablet versus co-administration of separate saxagliptin tablet and metformin IR tablet) in the fasted and fed state, linear mixed model analyses were performed on log(Cmax), log\[AUC(INF)\] and log\[AUC(0-T)\] of saxagliptin and metformin, respectively. The factors in the model were sequence, period and treatment as fixed effects and subject within sequence as a random effect.||1.016|0.864|
72340314|NCT00897390|144204342|NON_INFERIORITY_OR_EQUIVALENCE|Point estimates and 90% confidence intervals were calculated for the Arm B to Arm A and Arm D to Arm C ratios of geometric means for Cmax, AUC(INF) and AUC(0-T) of saxagliptin and metformin, respectively. Potency-corrected results were also provided. Bioequivalence will be concluded if the 90% confidence intervals for the test-to-reference ratios of geometric means are entirely contained within 80% to 125% for both Cmax and AUC(INF). No adjustments were made for multiplicity.|adjusted geometric mean|0.964|||||TWO_SIDED|90.0|0.891|1.042||||||To demonstrate the bioequivalence of formulation (FDC tablet versus co-administration of separate saxagliptin tablet and metformin IR tablet) in the fasted and fed state, linear mixed model analyses were performed on log(Cmax), log\[AUC(INF)\] and log\[AUC(0-T)\] of saxagliptin and metformin, respectively. The factors in the model were sequence, period and treatment as fixed effects and subject within sequence as a random effect.||1.042|0.891|
72340315|NCT01294163|144204354|NON_INFERIORITY_OR_EQUIVALENCE|Xenon was to be concluded non-inferior to sevoflurane if the upper bound of the 2-sided 95% CI for the difference \[mean troponin I level (xenon) - mean troponin I level (sevoflurane)\] was below the prespecified margin of 0.63 ng/mL. Assuming a margin of 0.63, a same concentration of troponin I at 24 hours in the xenon and sevoflurane groups, a common standard deviation of 1.9 ng/mL and a one-sided type I error of 0.025, 164 patients per group were deemed necessary to demonstrate non-inferiority.|Mean Difference (Final Values)|-0.4||||0.02|TWO_SIDED|95.0|-1.27|0.47|||ANCOVA|Treatment difference and 95%CI assessed using ANCOVA with 24h troponin I as response, treatment group and pre-induction troponin I as covariates.||||0.47|-1.27|0.02
72340316|NCT01294163|144204363|NON_INFERIORITY_OR_EQUIVALENCE|It was to be concluded that xenon was non-inferior to sevoflurane if the upper bound of the 2-sided 95% CI for the difference \[mean troponin I level (xenon) - mean troponin I level (sevoflurane)\] was below the margin of 0.15 ng/mL.|Mean Difference (Final Values)|-0.09||||0.0186|TWO_SIDED|95.0|-0.3|0.11|||ANCOVA|||As the residuals from the primary ANCOVA model were non-normal and skewed, the non-inferiority analysis was repeated using log-transformed blood troponin levels.||0.11|-0.30|0.0186
72370034|NCT00856518|144250527|SUPERIORITY_OR_OTHER|||||||0.004|||||||Wilcoxon Signed Ranks Test|EMST arm post vs. pre-treatment comparison in Fear domain||||||0.004
72340317|NCT00958217|144204364|SUPERIORITY_OR_OTHER||2nd order effects of time (2 slope|33.0|||<|0.05|TWO_SIDED|95.0||||P-values based on likelihood ratio tests for the significance of the first and second order trajectory parameters. Primary tests compared curvilinear trajectories of the two treatment groups.|Linear Mixed Effects Models||We gauged sampling error with 95% confidence bands.|Data analyses included comparison of mean scores and linear mixed effects models used to ascertain trajectories for depression symptoms.||||<.05
72340318|NCT00958217|144204365|SUPERIORITY_OR_OTHER||Second order effect of time (2 slopes)|57.0|||<|0.05|TWO_SIDED|95.0|||||Linear Mixed Effects Models||We gauged sampling error with 95% confidence bands.|||||<.05
72340319|NCT00958217|144204366|SUPERIORITY_OR_OTHER||Second order effect of time (2 slopes)|0.43|||<|0.05|TWO_SIDED|95.0|||||Linear Mixed Effects Model|A logit link was used in this model.|We gauged sampling error with 95% confidence bands.|Analysis of substance use was conducted using trajectories modeled as a dichotomous outcome using logit links to predict the probability of substance use (any alcohol or drug use) on a particular day.||||<.05
72340320|NCT00958217|144204366|SUPERIORITY_OR_OTHER||Second order effect of time (2 slopes)|0.26|||<|0.05|TWO_SIDED||||||Linear Mixed Effects Model|A logit link was used in this model|We gauged sampling error with 95% confidence bands.|Second statistical analysis evaluates trajectories of heavy drinking (\<5 drinks on a given day) Analysis of heavy drinking was conducted using trajectories modeled as a dichotomous outcome using logit links to predict the probability of heavy drinking (5 or more drinks) on a particular day.||||<.05
72340321|NCT02440789|144204391|OTHER|||||||0.56|||||||t-test, 2 sided|paired t-test||||||0.56
72340322|NCT02440789|144204393|OTHER|||||||0.11|||||||t-test, 2 sided|paired t-test||||||0.11
72340323|NCT02440789|144204395|OTHER|||||||0.93|||||||t-test, 2 sided|paired t-test; results less than the analysis lower limit (0.7 cp/mL) were imputed to a value of one half the analysis lower limit.||||||0.93
72340324|NCT02440789|144204397|OTHER|||||||0.041|||||||t-test, 2 sided|paired t-test||||||0.041
72340325|NCT02440789|144204400|OTHER|||||||0.008|||||||t-test, 2 sided|paired t-test||||||0.008
72340326|NCT02440789|144204402|OTHER|||||||0.26|||||||t-test, 2 sided|paired t-test||||||0.26
72340327|NCT02440789|144204404|OTHER|||||||0.75|||||||t-test, 2 sided|paired t-test||||||0.75
72340328|NCT02440789|144204406|OTHER|||||||0.97|||||||t-test, 2 sided|paired t-test||||||0.97
72340329|NCT02440789|144204408|OTHER|||||||0.7|||||||t-test, 2 sided|paired t-test||||||0.7
72340330|NCT02440789|144204410|OTHER|||||||0.47|||||||t-test, 2 sided|paired t-test||||||0.47
72340331|NCT02440789|144204412|OTHER|||||||0.72|||||||t-test, 2 sided|paired t-test||||||0.72
72340332|NCT02440789|144204414|OTHER|||||||0.28|||||||t-test, 2 sided|paired t-test||||||0.28
72340333|NCT02440789|144204416|OTHER|||||||0.7|||||||t-test, 2 sided|paired t-test||||||0.7
72340334|NCT02440789|144204418|OTHER|||||||0.28|||||||t-test, 2 sided|paired t-test||||||0.28
72340335|NCT02440789|144204420|OTHER|||||||0.77|||||||t-test, 2 sided|paired t-test||||||0.77
72340336|NCT02440789|144204422|OTHER|||||||0.93|||||||t-test, 2 sided|paired t-test||||||0.93
72340337|NCT02440789|144204424|OTHER|||||||0.65|||||||t-test, 2 sided|paired t-test||||||0.65
72428399|NCT01327547|144367749|SUPERIORITY_OR_OTHER||Difference in LS mean|-0.02||||0.7275|TWO_SIDED|95.0|-0.16|0.11|||ANCOVA||Difference in LS Mean|Results are from an ANCOVA model with change from baseline at Week 144 as the response variable and the following fixed effect model terms: treatment (Maraviroc or placebo), baseline value of the response variable, HBV, PI-based regimen.||0.11|-0.16|0.7275
72340338|NCT02440789|144204426|OTHER|||||||0.22|||||||t-test, 2 sided|paired t-test||||||0.22
72340339|NCT02440789|144204428|OTHER|||||||0.031|||||||t-test, 2 sided|paired t-test||||||0.031
72340340|NCT02440789|144204430|OTHER|||||||0.005|||||||t-test, 2 sided|paired t-test||||||0.005
72340341|NCT02440789|144204432|OTHER|||||||0.69|||||||t-test, 2 sided|paired t-test||||||0.69
72340342|NCT02440789|144204434|OTHER|||||||0.008|||||||t-test, 2 sided|paired t-test||||||0.008
72340343|NCT02564978|144204446|SUPERIORITY||Slope|-0.03|STANDARD_ERROR_OF_MEAN|0.03||0.39|TWO_SIDED|||||Result of statistical analyses were considered significant if the p-value from the one-sided test was \<0.025. No adjustments for multiplicity were made.|Mixed Models Analysis||The estimate was the difference in rates of change in mean of appropriately transformed GA area between the treatment phase and run-in phase.|Analysis: linear spline regression with fixed knot @ Month 9 on study eyes alone. Null hypothesis: difference in rates of change in mean of square-root transformed GA area between treatment phase \& run-in phase \>= 0. Square root transformation used to satisfy the linear trend assumption. Missing values: treated as missing completely at random. Covariance structure of random effect that provided best model fit chosen (Spatial Power). One-sided Type I error rate: 2.5%.||||0.39
72340344|NCT02564978|144204447|SUPERIORITY||Mean Difference (Final Values)|-0.01||||0.48|TWO_SIDED|95.0|-0.06|0.03||Result of statistical analyses were considered significant if the p-value from the two-sided Student's paired t-test was \<0.05. No adjustments for multiplicity were made.|t-test, 2 sided|||Analysis: two-sided Student's paired t-test on study eyes alone. Null hypothesis: difference in rates of change in mean of square-root transformed GA area between the treatment phase and run-in phase is not equal to 0. Missing values: treated as missing completely at random. Two-sided Type I error rate: 5%.||0.03|-0.06|0.48
72340345|NCT02564978|144204447|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.15|TWO_SIDED|95.0|-0.24|0.04||Result of statistical analyses were considered significant if the p-value from the two-sided Student's paired t-test was \<0.05. No adjustments for multiplicity were made.|t-test, 2 sided|||Analysis: two-sided Student's paired t-test on qualifying fellow eyes alone. Null hypothesis: difference in rates of change in mean of square-root transformed GA area between the treatment phase and run-in phase is not equal to 0. Missing values: treated as missing completely at random. Two-sided Type I error rate: 5%.||0.04|-0.24|0.15
72368377|NCT00298558|144246916|SUPERIORITY_OR_OTHER||Effect Size|-0.11||||0.17|TWO_SIDED|99.0|-0.31|0.1|||Mixed Models Analysis|The blom transformation was used to reduce skewness in the measures. The design factors and baseline covariates were controlled in the model.|Blom transformed outcome was used and the design factors and baseline covariates were controlled in the model to get the adjusted means. After that, the effect size (defined in the Additional details) was calculated using the adjusted means and SD.|Effect size was defined as training improvement from baseline to year 10 minus control improvement from baseline to year 10 divided by the intrasubject standard deviation (SD) of the composite score. Positive effect sizes indicate improvement.||0.10|-0.31|0.17
72340346|NCT02564978|144204447|SUPERIORITY||Mean Difference (Final Values)|-0.04||||0.15|TWO_SIDED|95.0|-0.09|0.01||Result of statistical analyses were considered significant if the p-value from the two-sided Student's paired t-test was \<0.05. No adjustments for multiplicity were made.|t-test, 2 sided||No. of units analyzed = no. of study eyes + no. qualifying fellow eyes (QFE). However, the value contributing to analysis is the avg. of study eye \& QFE from a participant if both values are available, otherwise equal to eye with data available.|Analysis: two-sided Student's paired t-test on study and qualifying fellow eyes (Study eye + QFE) together. Null hypothesis: difference in rates of change in mean of square-root transformed GA area between the treatment phase and run-in phase is not equal to 0. Missing values: treated as missing completely at random. Two-sided Type I error rate: 5%.||0.01|-0.09|0.15
72340347|NCT02564978|144204448|SUPERIORITY||Slope|0.03|STANDARD_ERROR_OF_MEAN|0.05||0.61|TWO_SIDED|||||Result of statistical analyses were considered significant if the p-value from the one-sided test was \<0.025. No adjustments for multiplicity were made.|Mixed Models Analysis||The estimate was the difference in rates of change in mean of appropriately transformed GA area between the treatment phase and run-in phase.|Analysis: linear spline regression with fixed knot @ Month 9 on study eyes alone. Null hypothesis: difference in rates of change in mean of square-root transformed GA area between treatment phase \& run-in phase \>= 0. Square root transformation used to satisfy the linear trend assumption. Missing values: treated as missing completely at random. Covariance structure of random effect that provided best model fit chosen (Spatial Power). One-sided Type I error rate: 2.5%.||||0.61
72340348|NCT02564978|144204448|SUPERIORITY||Slope|-0.06|STANDARD_ERROR_OF_MEAN|0.08||0.43|TWO_SIDED|||||Result of statistical analyses were considered significant if the p-value from the one-sided test was \<0.025. No adjustments for multiplicity were made.|Mixed Models Analysis||The estimate was the difference in rates of change in mean of appropriately transformed GA area between the treatment phase and run-in phase.|Analysis: linear spline regression with fixed knot @ Month 9 on qualifying fellow eyes alone. Null hypothesis: difference in rates of change in mean of square-root transformed GA area between treatment phase \& run-in phase \>= 0. Square root transformation used to satisfy the linear trend assumption. Missing values: treated as missing completely at random. Covariance structure of random effect that provided best model fit chosen (Spatial Power). One-sided Type I error rate: 2.5%.||||0.43
72340349|NCT02564978|144204448|SUPERIORITY||Slope|-0.01|STANDARD_ERROR_OF_MEAN|0.04||0.89|TWO_SIDED|||||Result of statistical analyses were considered significant if the p-value from the one-sided test was \<0.025. No adjustments for multiplicity were made.|Mixed Models Analysis||Study eye + QFE: study \& qualifying fellow eyes analyzed as separate observations. Estimate: difference in rate of change in mean of appropriately transformed GA area between treatment and run-in phase.|Analysis: linear spline regression with fixed knot @ Month 9 on study and qualifying fellow eyes together. Null hypothesis: difference in rates of change in mean of square-root transformed GA area between treatment phase \& run-in phase \>= 0. Square root transformation used to satisfy the linear trend assumption. Missing values: treated as missing completely at random. Covariance structure of random effect that provided best model fit chosen (Spatial Power). One-sided Type I error rate: 2.5%.||||0.89
72340350|NCT02564978|144204449|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.44|TWO_SIDED|95.0|-0.4|0.9||Result of statistical analyses were considered significant if the p-value from the two-sided Student's paired t-test was \<0.05. No adjustments for multiplicity were made.|t-test, 2 sided|||Analysis: two-sided Student's paired t-test on study eyes alone. Null hypothesis: difference in the mean rates of change in BCVA between the treatment phase and run-in phase is not equal to 0. Missing values: treated as missing completely at random. Two-sided Type I error rate: 5%.||0.9|-0.4|0.44
72340351|NCT02564978|144204449|SUPERIORITY||Mean Difference (Final Values)|-0.3||||0.21|TWO_SIDED|95.0|-0.8|0.2||Result of statistical analyses were considered significant if the p-value from the two-sided Student's paired t-test was \<0.05. No adjustments for multiplicity were made.|t-test, 2 sided|||Analysis: two-sided Student's paired t-test on qualifying fellow eyes alone. Null hypothesis: difference in the mean rates of change in BCVA between the treatment phase and run-in phase is not equal to 0. Missing values: treated as missing completely at random. Two-sided Type I error rate: 5%.||0.2|-0.8|0.21
72340352|NCT02564978|144204449|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.52|TWO_SIDED|95.0|-0.4|0.8||Result of statistical analyses were considered significant if the p-value from the two-sided Student's paired t-test was \<0.05. No adjustments for multiplicity were made.|t-test, 2 sided||No. of units analyzed = no. of study eyes + no. qualifying fellow eyes (QFE). However, the value contributing to analysis is the avg. of study eye \& QFE from a participant if both values are available, otherwise equal to eye with data available.|Analysis: two-sided Student's paired t-test on study and qualifying fellow eyes together (Study eye + QFE). Null hypothesis: difference in the mean rates of change in BCVA between the treatment phase and run-in phase is not equal to 0. Missing values: treated as missing completely at random. Two-sided Type I error rate: 5%.||0.8|-0.4|0.52
72340353|NCT02564978|144204450|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.48|TWO_SIDED|95.0|-0.4|0.9||Result of statistical analyses were considered significant if the p-value from the two-sided Student's paired t-test was \<0.05. No adjustments for multiplicity were made.|t-test, 2 sided|||Analysis: two-sided Student's paired t-test on study eyes alone. Null hypothesis: difference in the mean rates of change in LLVA between the treatment phase and run-in phase is not equal to 0. Missing values: treated as missing completely at random. Two-sided Type I error rate: 5%.||0.9|-0.4|0.48
72340354|NCT02564978|144204450|SUPERIORITY||Mean Difference (Final Values)|-0.4||||0.09|TWO_SIDED|95.0|-0.9|0.1||Result of statistical analyses were considered significant if the p-value from the two-sided Student's paired t-test was \<0.05. No adjustments for multiplicity were made.|t-test, 2 sided|||Analysis: two-sided Student's paired t-test on qualifying fellow eyes alone. Null hypothesis: difference in the mean rates of change in LLVA between the treatment phase and run-in phase is not equal to 0. Missing values: treated as missing completely at random. Two-sided Type I error rate: 5%.||0.1|-0.9|0.09
72370035|NCT00856518|144250527|SUPERIORITY_OR_OTHER|||||||0.016|||||||Wilcoxon Signed Ranks Test|EMST arm post vs. pre-treatment comparison in Total SWAL-QOL score||||||0.016
72370036|NCT00926029|144250539|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANOVA|||The null hypothesis states that there is no difference between groups.||||0.05
72370037|NCT00926029|144250540|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANOVA|||The null hypothesis states that there is no difference between groups.||||0.05
72340355|NCT02564978|144204450|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.54|TWO_SIDED|95.0|-0.4|0.7||Result of statistical analyses were considered significant if the p-value from the two-sided Student's paired t-test was \<0.05. No adjustments for multiplicity were made.|t-test, 2 sided||No. of units analyzed = no. of study eyes + no. qualifying fellow eyes (QFE). However, the value contributing to analysis is the avg. of study eye \& QFE from a participant if both values are available, otherwise equal to eye with data available.|Analysis: two-sided Student's paired t-test on study and qualifying fellow eyes together (Study eye + QFE). Null hypothesis: difference in the mean rates of change in LLVA between the treatment phase and run-in phase is not equal to 0. Missing values: treated as missing completely at random. Two-sided Type I error rate: 5%.||0.7|-0.4|0.54
72340356|NCT02564978|144204451|SUPERIORITY||Mean Difference (Final Values)|0.7||||0.2|TWO_SIDED|95.0|-0.4|1.8||Result of statistical analyses were considered significant if the p-value from the two-sided Student's paired t-test was \<0.05. No adjustments for multiplicity were made.|t-test, 2 sided|||Analysis: two-sided Student's paired t-test on study eyes alone. Null hypothesis: difference in the mean rate of change of central retinal thickness as measured on OCT between the treatment phase and run-in phase is not equal to 0. Missing values: treated as missing completely at random. Two-sided Type I error rate: 5%.||1.8|-0.4|0.20
72340357|NCT02564978|144204451|SUPERIORITY||Mean Difference (Final Values)|1.8||||0.02|TWO_SIDED|95.0|0.4|3.1||Result of statistical analyses were considered significant if the p-value from the two-sided Student's paired t-test was \<0.05. No adjustments for multiplicity were made.|t-test, 2 sided|||Analysis: two-sided Student's paired t-test on qualifying fellow eyes alone. Null hypothesis: difference in the mean rate of change of central retinal thickness as measured on OCT between the treatment phase and run-in phase is not equal to 0. Missing values: treated as missing completely at random. Two-sided Type I error rate: 5%.||3.1|0.4|0.02
72340358|NCT02564978|144204451|SUPERIORITY|Number of eyes contributing to this analysis exceeds the number of eyes contributing to the study eye only analysis since one participant had relevant data for the qualifying fellow eye but not the study eye.|Mean Difference (Final Values)|1.0||||0.06|TWO_SIDED|95.0|0.0|2.0||Result of statistical analyses were considered significant if the p-value from the two-sided Student's paired t-test was \<0.05. No adjustments for multiplicity were made.|t-test, 2 sided||No. of units analyzed = no. of study eyes + no. qualifying fellow eyes (QFE). However, the value contributing to analysis is the avg. of study eye \& QFE from a participant if both values are available, otherwise equal to eye with data available.|Analysis: two-sided Student's paired t-test on study and qualifying fellow eyes together (Study eye + QFE). Null hypothesis: difference in the mean rate of change of central retinal thickness as measured on OCT between the treatment phase and run-in phase is not equal to 0. Missing values: treated as missing completely at random. Two-sided Type I error rate: 5%.||2.0|0.0|0.06
72340359|NCT01307462|144204513|SUPERIORITY|||||||0.81|||||||Wilcoxon (Mann-Whitney)|||SF-36 norm-based physical functioning score||||.81
72340360|NCT01307462|144204513|SUPERIORITY|||||||0.18|||||||Wilcoxon (Mann-Whitney)|||SF-36 norm-based role-physical score||||.18
72340361|NCT01307462|144204513|SUPERIORITY|||||||0.48|||||||Wilcoxon (Mann-Whitney)|||SF-36 norm-based bodily pain score||||.48
72340362|NCT01307462|144204513|SUPERIORITY|||||||0.26|||||||Wilcoxon (Mann-Whitney)|||SF-36 norm-based general health score||||.26
72340363|NCT01307462|144204513|SUPERIORITY|||||||0.23|||||||Wilcoxon (Mann-Whitney)|||SF-36 norm-based vitality score||||.23
72340364|NCT01307462|144204513|SUPERIORITY|||||||0.36|||||||Wilcoxon (Mann-Whitney)|||SF-36 norm-based social functioning score||||.36
72340365|NCT01307462|144204513|SUPERIORITY|||||||0.41|||||||Wilcoxon (Mann-Whitney)|||SF-36 norm-based role-emotional score||||.41
72340366|NCT01307462|144204513|SUPERIORITY|||||||0.8|||||||Wilcoxon (Mann-Whitney)|||SF-36 norm-based mental health score||||.80
72340367|NCT01307462|144204513|SUPERIORITY|||||||0.8|||||||Wilcoxon (Mann-Whitney)|||SF-36 standardized physical component score||||.80
72340368|NCT01307462|144204513|SUPERIORITY|||||||0.23|||||||Wilcoxon (Mann-Whitney)|||SF-36 standardized mental component score||||.23
72340369|NCT01307462|144204514|SUPERIORITY|||||||0.28|||||||Wilcoxon (Mann-Whitney)|||FACT physical well-being||||0.28
72340370|NCT01307462|144204514|SUPERIORITY|||||||0.1|||||||Wilcoxon (Mann-Whitney)|||FACT social/family well-being||||0.1
72340371|NCT01307462|144204514|SUPERIORITY|||||||0.63|||||||Wilcoxon (Mann-Whitney)|||FACT emotional well-being||||0.63
72340372|NCT01307462|144204514|SUPERIORITY|||||||0.78|||||||Wilcoxon (Mann-Whitney)|||FACT functional well-being||||0.78
72340373|NCT01307462|144204514|SUPERIORITY|||||||0.84|||||||Wilcoxon (Mann-Whitney)|||FACT BMT subscale||||.84
72340374|NCT01307462|144204514|SUPERIORITY|||||||0.37|||||||Wilcoxon (Mann-Whitney)|||FACT trial outcome index||||.37
72340375|NCT01307462|144204514|SUPERIORITY|||||||0.71|||||||Wilcoxon (Mann-Whitney)|||FACT-G||||.71
72340376|NCT01307462|144204514|SUPERIORITY|||||||0.54|||||||Wilcoxon (Mann-Whitney)|||FACT-BMT total||||.54
72340377|NCT01307462|144204515|SUPERIORITY|||||||0.37|||||||Wilcoxon (Mann-Whitney)|||HAP maximum activity score - highest item still doing||||.37
72340378|NCT01307462|144204515|SUPERIORITY|||||||0.39|||||||Wilcoxon (Mann-Whitney)|||HAP adjusted activity score - MAS minus stopped||||.39
72340379|NCT01307462|144204515|SUPERIORITY|||||||0.39|||||||Wilcoxon (Mann-Whitney)|||Modified HAP adjusted activity score||||.39
72340380|NCT01307462|144204516|SUPERIORITY|||||||0.11|||||||Wilcoxon (Mann-Whitney)|||Lee symptom skin scale||||.11
72340381|NCT01307462|144204516|SUPERIORITY|||||||0.007|||||||Wilcoxon (Mann-Whitney)|||Lee symptom energy scale||||.007
72340382|NCT01307462|144204516|SUPERIORITY|||||||0.2|||||||Wilcoxon (Mann-Whitney)|||Lee symptom lung scale||||.20
72340383|NCT01307462|144204516|SUPERIORITY|||||||0.002|||||||Wilcoxon (Mann-Whitney)|||Lee symptom eye scale||||.002
72340384|NCT01307462|144204516|SUPERIORITY|||||||0.52|||||||Wilcoxon (Mann-Whitney)|||Lee symptom nutrition scale||||.52
72340385|NCT01307462|144204516|SUPERIORITY|||||||0.22|||||||Wilcoxon (Mann-Whitney)|||Lee symptom psychological scale||||.22
72340386|NCT01307462|144204516|SUPERIORITY|||||||0.002|||||||Wilcoxon (Mann-Whitney)|||Lee symptom mouth scale||||.002
72340387|NCT01307462|144204516|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Lee symptom overall summary scale||||<0.001
72340388|NCT03875664|144204528|SUPERIORITY||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
72340389|NCT05065190|144204529|OTHER||Adjusted difference|106.57|STANDARD_ERROR_OF_MEAN|76.84|||TWO_SIDED|95.0|-47.13|260.28|||||Adjusted difference between treatment groups was based on a random slope and intercept model with fixed effects for treatment, HRCT pattern, and baseline FVC \[mL\], and including treatment-by-time and baseline-by-time interactions.|||260.28|-47.13|
72340390|NCT04253587|144204559|EQUIVALENCE|The null hypothesis was no difference between mean change scores for time-points X conditions.|Mean Difference (Net)|0.06|STANDARD_ERROR_OF_MEAN|0.03|=|0.016|TWO_SIDED|95.0|-0.06|0.06||Mixed effects ANOVA applied family wise error for post-hoc tests according to a priori hypothesis|ANOVA|||||0.06|-0.06|= 0.016
72340391|NCT04253587|144204560|SUPERIORITY||Mean Difference (Final Values)|0.03|STANDARD_ERROR_OF_MEAN|0.035|=|0.22|TWO_SIDED|95.0|-0.03|0.03|||ANOVA|effect of condition (F1,20 = 1.616, p = 0.22), effect of time (F1,20 = 0.613, p = 0.44)||||0.03|-0.03|= 0.22
72340392|NCT03320330|144204570|OTHER|Recommended Phase 2 dose of pepinemab (VX15/2503), administered to children with recurrent or refractory solid tumors (Part A), was determined by the rolling-6 design.|Recommended Phase 2 dose|20.0|||||TWO_SIDED||||||||Recommended Phase 2 dose of pepinemab (VX15/2503) is 20 mg/kg.|||||
72340393|NCT01885910|144204591|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<.0001
72340394|NCT04692077|144204634|OTHER||Exact CI for Proportions|88.9|||||TWO_SIDED|95.0|51.8|99.7|||||||Exact 95% Confidence Interval for Proportion for Participants who Reported Grade 2 and Above AEs|99.7|51.8|
72340395|NCT04692077|144204635|OTHER||Exact CI for Proportions|11.1|||||TWO_SIDED|95.0|0.3|48.3|||||||Exact 95% Confidence Interval for Proportion for Participants who Discontinued Early due to Intolerability of Injection or Burden of Study Procedures|48.3|0.3|
72340396|NCT04692077|144204636|OTHER||Exact CI for Proportions|66.7|||||TWO_SIDED|95.0|22.3|95.7|||||||Exact 95% confidence interval for proportion for Participants who received at least one injection and preferred injectable PrEP at end of step 2.|95.7|22.3|
72340397|NCT04692077|144204640|OTHER||Exact CI for Proportions|88.9|||||TWO_SIDED|95.0|51.8|99.7|||||||The Exact 95% Confidence Interval for Proportion for Number of Participants with Grade 2 or above AEs during Injection Phase.|99.7|51.8|
72340398|NCT04692077|144204641|OTHER||Exact CI for Proportions|88.9|||||TWO_SIDED|95.0|51.8|99.7|||||||Exact 95% Confidence Interval for Proportion for Participants who Completed All Scheduled Injections among those who received at least one Injection|99.7|51.8|
72340399|NCT04243330|144204645|SUPERIORITY||Mean Difference (Net)|1.01||||0.18|TWO_SIDED|95.0|-0.46|2.48||the p-values are not adjusted for multiple comparisons and the a priori threshold for statistical significance is 0.05|Mixed Models Analysis|||||2.48|-0.46|0.18
72340400|NCT04243330|144204646|SUPERIORITY||Mean Difference (Net)|3.58||||0.06|TWO_SIDED|95.0|-0.11|7.28||the p-values are not adjusted for multiple comparisons and the a priori threshold for statistical significance is 0.05|Mixed Models Analysis|||||7.28|-0.11|.06
72428400|NCT01327547|144367750|SUPERIORITY_OR_OTHER||Difference in LS Mean|0.07||||0.5201|TWO_SIDED|95.0|-0.15|0.3|||ANCOVA||Difference in LS Mean|Results are from an ANCOVA model with change from baseline at Week 48 as the response variable and the following fixed effect model terms: treatment (Maraviroc or placebo), baseline value of the response variable, HBV, PI-based regimen.||0.30|-0.15|0.5201
72340401|NCT04243330|144204647|SUPERIORITY||Median Difference (Net)|1.7||||0.6|TWO_SIDED|95.0|-4.5|7.9||the p-values are not adjusted for multiple comparisons and the a priori threshold for statistical significance is 0.05|Mixed Models Analysis|||||7.9|-4.5|0.60
72340402|NCT04243330|144204648|SUPERIORITY||Median Difference (Net)|-4.1||||0.36|TWO_SIDED|95.0|-12.8|4.7||p-values are not adjusted for multiple comparisons and the a priori threshold for statistical significance is 0.05|Mixed Models Analysis|||||4.7|-12.8|0.36
72340403|NCT04243330|144204649|SUPERIORITY||Mean Difference (Net)|-4.5||||0.02|TWO_SIDED|95.0|-8.3|-0.67||p-values are not adjusted for multiple comparisons and the a priori threshold for statistical significance is 0.05|Mixed Models Analysis|||||-0.67|-8.3|.02
72340404|NCT04243330|144204650|SUPERIORITY||Mean Difference (Net)|-0.56||||0.82|TWO_SIDED|95.0|-5.5|4.4|||Mixed Models Analysis|||||4.4|-5.5|0.82
72340405|NCT02753127|144204651|SUPERIORITY||Hazard Ratio (HR)|0.976||||0.3629|TWO_SIDED|95.0|0.854|1.117||1-sided|Log Rank|Based on stratified log-rank test stratified by actual stratification factors. P-value is nominal p-value without multiplicity adjustment.|"Based on Cox Proportional hazards model stratified by actual stratification factors including Time to progression on 1st line therapy, RAS mutation, and Bev as part of study treatment.~A HR \<1 indicates a lower risk with Arm 1 compared with Arm 2."|General population||1.117|0.854|0.3629
72340406|NCT02753127|144204651|SUPERIORITY||Hazard Ratio (HR)|0.969||||0.3782|TWO_SIDED|95.0|0.797|1.179||1-sided|Log Rank|Based on unstratified log-rank test. P-value is nominal p value without multiplicity adjustment.|Hazard Ratio is for Napabucasin + FOLFIRI ± bev vs FOLFIRI ± bev. Based on unstratified Cox proportional hazards model. A hazard ratio \<1 indicates a lower risk with Napabucasin+ FOLFIRI ± bev compared with FOLFIRI ± bev.|activated signal transducers and activators of transcription 3 (pSTAT3)-positive (pSTAT3(+)) Subpopulation patients||1.179|0.797|0.3782
72340407|NCT02753127|144204652|SUPERIORITY||Hazard Ratio (HR)|1.04||||0.7307|TWO_SIDED|95.0|0.917|1.18||1-sided|Log Rank|"Based on stratified log rank test stratified by actual stratification factors~. P-value is nominal p-value without multiplicity adjustment."|"Based on Cox Proportional hazards model stratified by actual stratification~. A HR \<1 indicates a lower risk with Arm 1 compared with Arm 2."|General population||1.180|0.917|0.7307
72340408|NCT02753127|144204652|SUPERIORITY||Hazard Ratio (HR)|1.064||||0.7434|TWO_SIDED|95.0|0.883|1.283||1-sided|Log Rank|Based on unstratified log-rank test. P-value is nominal p-value without multiplicity adjustment.|Hazard ratio is for Napabucasin + FOLFIRI ± bev vs FOLFIRI ± bev. Based on unstratified Cox Proportional hazards model. A hazard ratio \<1 indicates a lower risk with Napabucasin + FOLFIRI ± bev compared with FOLFIRI ± bev.|activated signal transducers and activators of transcription 3 (pSTAT3)-positive (pSTAT3(+)) Subpopulation patients||1.283|0.883|0.7434
72340409|NCT02753127|144204653|SUPERIORITY||rate difference|0.1||||0.4797|TWO_SIDED|95.0|-4.9|5.2||1-sided|Cochran-Mantel-Haenszel|Based on Cochran-Mantel-Haenszel test stratified by actual stratification factors. P-value is nominal p-value without multiplicity adjustment .|Treatment difference and 95% CI is based on Harmonic Means method adjusting stratification factor|General population||5.2|-4.9|0.4797
72340410|NCT02753127|144204653|SUPERIORITY||rate difference|-3.1||||0.783|TWO_SIDED|95.0|-11.0|4.7||1-sided|Z test|Based on one-sided Z test. P-value is nominal p-value without multiplicity adjustment.|Treatment difference and 95% CI is based on normal approximation method.|activated signal transducers and activators of transcription 3 (pSTAT3)-positive (pSTAT3(+)) Subpopulation patients||4.7|-11.0|0.783
72340411|NCT02753127|144204654|SUPERIORITY||rate difference|-0.9||||0.6776|TWO_SIDED|95.0|-4.8|3.0||1-sided|Cochran-Mantel-Haenszel|Based on Cochran-Mantel-Haenszel test stratified by actual stratification factors. P-value is nominal p-value without multiplicity adjustment.|Treatment difference and 95% CI is based on Harmonic Means method adjusting stratification factor|General population||3.0|-4.8|0.6776
72340412|NCT02753127|144204654|SUPERIORITY||rate difference|-2.0||||0.7513|TWO_SIDED|95.0|-7.7|3.7||1-sided|Z test|Based on one-sided Z test. P-value is nominal p-value without multiplicity adjustment.|Treatment difference and 95% CI is based on normal approximation method.|activated signal transducers and activators of transcription 3 (pSTAT3)-positive (pSTAT3(+)) Subpopulation patients||3.7|-7.7|0.7513
72340413|NCT03826342|144204658|SUPERIORITY|||||||0.2964|||||||Generalized linear mixed model analysis|generalized linear mixed model analysis under a negative binomial framework||Baseline to 2-month assessment||||0.2964
72340414|NCT03826342|144204658|SUPERIORITY|||||||0.3404|||||||generalized linear mixed model analysis|generalized linear mixed model analysis under a negative binomial framework||2-month assessment to 6-month assessment||||0.3404
72340415|NCT03826342|144204659|SUPERIORITY|||||||0.7915|||||||Generalized linear mixed model analysis|generalized linear mixed model analysis under a negative binomial framework||Baseline to 2-month assessment||||0.7915
72340416|NCT03826342|144204659|SUPERIORITY|||||||0.2131|||||||generalized linear mixed model analysis|generalized linear mixed model analysis under a negative binomial framework||2-month assessment to 6-month assessment||||0.2131
72340417|NCT03826342|144204660|SUPERIORITY|||||||0.8357|||||||Generalized linear mixed model analysis|generalized linear mixed model analysis under a negative binomial framework||Baseline to 2-month assessment||||0.8357
72340418|NCT03826342|144204660|SUPERIORITY|||||||0.095|||||||generalized linear mixed model analysis|generalized linear mixed model analysis under a negative binomial framework||2-month assessment to 6-month assessment||||0.0950
72340419|NCT03826342|144204661|SUPERIORITY|||||||0.7496|||||||generalized linear mixed model analysis|generalized linear mixed model analysis under a negative binomial framework||||||0.7496
72340420|NCT03826342|144204662|SUPERIORITY|||||||0.4492|||||||generalized linear mixed model analysis|generalized linear mixed model analysis under a negative binomial framework||||||0.4492
72340421|NCT03826342|144204663|SUPERIORITY|||||||0.0765|||||||t-test, 2 sided|||||||0.0765
72340422|NCT03826342|144204664|SUPERIORITY|||||||0.535|||||||t-test, 2 sided|||||||0.535
72340423|NCT03826342|144204665|SUPERIORITY|||||||0.4302|||||||t-test, 2 sided|||||||0.4302
72340424|NCT03826342|144204666|SUPERIORITY|||||||0.807|||||||generalized linear mixed model analysis|generalized linear mixed model analysis under a negative binomial framework||||||0.8070
72340425|NCT01114360|144204694|SUPERIORITY_OR_OTHER|||||||0.075|TWO_SIDED||||||ANOVA|Two-way repeated measures mixed model ANOVA.||The null hypothesis is that there is no interaction between the order of randomization and primary outcomes.||||0.075
72340426|NCT01114360|144204694|SUPERIORITY_OR_OTHER|||||||0.75|TWO_SIDED||||||ANOVA|||||||0.75
72340427|NCT01114360|144204695|SUPERIORITY_OR_OTHER|||||||0.79|TWO_SIDED||||||ANOVA|||||||0.79
72340428|NCT01114360|144204696|SUPERIORITY_OR_OTHER|||||||0.21|TWO_SIDED||||||ANOVA|||||||0.21
72340429|NCT01114360|144204697|SUPERIORITY_OR_OTHER|||||||0.64|TWO_SIDED||||||ANOVA|||||||0.64
72340430|NCT01114360|144204698|SUPERIORITY_OR_OTHER|||||||0.89|TWO_SIDED||||||ANOVA|||||||0.89
72340431|NCT01114360|144204699|SUPERIORITY_OR_OTHER|||||||0.97|TWO_SIDED||||||ANOVA|||||||0.97
72340432|NCT01114360|144204700|SUPERIORITY_OR_OTHER|||||||0.01|TWO_SIDED||||||ANOVA|||||||0.01
72340433|NCT01114360|144204701|SUPERIORITY_OR_OTHER|||||||0.75|TWO_SIDED||||||ANOVA|||The null hypothesis is that there is no interaction between the order of randomization and primary outcomes.||||0.75
72340434|NCT01114360|144204702|SUPERIORITY_OR_OTHER|||||||0.71|TWO_SIDED||||||Friedman|||||||0.71
72340435|NCT01114360|144204703|SUPERIORITY_OR_OTHER|||||||0.38|TWO_SIDED||||||Friedman|||||||0.38
72340436|NCT01114360|144204704|SUPERIORITY_OR_OTHER|||||||0.11|TWO_SIDED||||||Friedman|||||||0.11
72340437|NCT01114360|144204705|SUPERIORITY_OR_OTHER|||||||0.96|TWO_SIDED||||||ANOVA|||||||0.96
72340438|NCT01114360|144204706|SUPERIORITY_OR_OTHER|||||||0.25|TWO_SIDED||||||ANOVA|||||||0.25
72340439|NCT01114360|144204707|SUPERIORITY_OR_OTHER|||||||0.52|TWO_SIDED||||||ANOVA|||||||0.52
72340440|NCT03007745|144204710|SUPERIORITY||Mean Difference (Final Values)|1.96|STANDARD_DEVIATION|3.08|<|0.0001|TWO_SIDED|||||Unadjusted|t-test, 2 sided|||Paired t-test comparing baseline and 3-month measures within group||||<0.0001
72340441|NCT03007745|144204710|SUPERIORITY||Mean Difference (Final Values)|1.73|STANDARD_DEVIATION|3.97|<|0.0001|TWO_SIDED||||||t-test, 2 sided|Unadjusted||Paired t-test comparing baseline and 3-month measures within group||||<0.0001
72340442|NCT03007745|144204710|SUPERIORITY||Mean Difference (Final Values)|-0.06|STANDARD_ERROR_OF_MEAN|0.61||0.9171|TWO_SIDED|||||Adjusted mean changes and adjusted differences in mean changes were estimated as site-total-sample-size weighted values controlling for treatment group differences in mean pre-treatment baseline values|ANCOVA|||Adjusted differences in mean changes were estimated as site-total-sample-size weighted values controlling for treatment group differences in mean pre-treatment baseline values. ANCOVA model included main effects for type of study (home versus in-laboratory), site, and the pre-treatment baseline value of the outcome measure.||||0.9171
72340443|NCT03007745|144204710|NON_INFERIORITY|We hypothesized that the lower bound of the non-inferiority analysis of FOSQ-10 would be greater than the a-priori threshold of -1.0.|||||>|0.05||||||"Adjusted group difference in mean change in FOSQ-10 score from baseline to Month 3, controlling for baseline FOSQ and site, was -0.06 ± 061 (SEM) (P = 0.917).~The lower bound of the 95% noninferiority confidence interval was -1.08"|ANCOVA|||||||>0.05
72340444|NCT03007745|144204711|SUPERIORITY||Mean Difference (Net)|-3.31|STANDARD_DEVIATION|4.86|<|0.0001|ONE_SIDED|||||Subjects initiated on CPAP and receiving a 3-month follow-up (LOCF applied using 1-month data) Paired t-test comparing baseline and 3-month measures within group|t-test, 2 sided|||Paired t-test comparing baseline and 3-month measures within group||||<0.0001
72340445|NCT03007745|144204711|SUPERIORITY||Mean Difference (Net)|-3.51|STANDARD_DEVIATION|5.52|<|0.0001|TWO_SIDED|||||Subjects initiated on CPAP and receiving a 3-month follow-up (LOCF applied using 1-month data) Paired t-test comparing baseline and 3-month measures within group|t-test, 2 sided|||Subjects initiated on CPAP and receiving a 3-month follow-up (LOCF applied using 1-month data) Paired t-test comparing baseline and 3-month measures within group||||<0.0001
72340446|NCT03007745|144204711|SUPERIORITY||Mean Difference (Final Values)|0.08|STANDARD_ERROR_OF_MEAN|0.85||0.9251|ONE_SIDED||||||ANCOVA|ANCOVA included main effects for group, site, and the pre-treatment baseline value of the outcome measure||Adjusted differences in mean changes were estimated as site-total-sample-size weighted values controlling for treatment group differences in mean pre-treatment baseline values. ANCOVA model included main effects for type of study (home versus in-laboratory), site, and the pre-treatment baseline value of the outcome measure.||||0.9251
72340447|NCT03007745|144204712|SUPERIORITY|Paired t-test comparing change in score (3-month - baseline) within group|Mean Difference (Final Values)|0.04|STANDARD_DEVIATION|0.33||0.4116|ONE_SIDED||||||t-test, 2 sided|Subjects initiated on CPAP and receiving a 3-month follow-up (LOCF applied using 1-month data)||Within arm change from baseline to 3 month follow-up||||0.4116
72340448|NCT03007745|144204712|SUPERIORITY||Mean Difference (Net)|-0.05|STANDARD_DEVIATION|0.39||0.2201|ONE_SIDED||||||t-test, 2 sided|||Paired t-test comparing change in score (3-month - baseline) within group||||0.2201
72340449|NCT03007745|144204712|SUPERIORITY||Mean Difference (Net)|0.08|STANDARD_ERROR_OF_MEAN|0.06||0.1732|TWO_SIDED||||||ANCOVA|ANCOVA included main effects for group, site, and the pre-treatment baseline value of the outcome measure||Adjusted differences in mean changes between groups from baseline to month 3 in participants initiated on CPAP (LOCF applied using 1-month data).||||0.1732
72340450|NCT03007745|144204713|SUPERIORITY||Mean Difference (Final Values)|-2.76|STANDARD_DEVIATION|4.73|<|0.0003|ONE_SIDED||||||t-test, 2 sided|Unadjusted||Paired t-test comparing baseline and 3-month measures within group||||<0.0003
72340451|NCT03007745|144204713|SUPERIORITY||Mean Difference (Final Values)|-2.38|STANDARD_DEVIATION|5.2|<|0.0001|TWO_SIDED||||||t-test, 2 sided|Unadjusted||Subjects initiated on CPAP and receiving a 3-month follow-up (LOCF applied using 1-month data) Paired t-test comparing baseline and 3-month measures within group||||<0.0001
72340452|NCT03007745|144204713|SUPERIORITY||Median Difference (Final Values)|-0.38|STANDARD_ERROR_OF_MEAN|0.9||0.673|TWO_SIDED||||||ANCOVA|ANCOVA included main effects for group, site, and the pre-treatment baseline value of the outcome measure||Adjusted differences in mean changes were estimated as site-total-sample-size weighted values controlling for treatment group differences in mean pre-treatment baseline values. Subjects initiated on CPAP and receiving a 3-month follow-up (LOCF applied using 1-month data)||||0.6730
72428401|NCT01327547|144367750|SUPERIORITY_OR_OTHER||Difference in LS Mean|-0.08||||0.4657|TWO_SIDED|95.0|-0.28|0.13|||ANCOVA|||Results are from an ANCOVA model with change from baseline at Week 96 as the response variable and the following fixed effect model terms: treatment (Maraviroc or placebo), baseline value of the response variable, HBV, PI-based regimen.||0.13|-0.28|0.4657
72428402|NCT01327547|144367750|SUPERIORITY_OR_OTHER||Difference in LS Mean|-0.03||||0.8087|TWO_SIDED|95.0|-0.25|0.2|||ANCOVA||Difference in LS Mean|Results are from an ANCOVA model with change from baseline at Week 144 as the response variable and the following fixed effect model terms: treatment (Maraviroc or placebo), baseline value of the response variable, HBV, PI-based regimen.||0.20|-0.25|0.8087
72428403|NCT01327547|144367751|SUPERIORITY_OR_OTHER||Difference in LS Mean|-1.84||||0.1417|TWO_SIDED|95.0|-4.31|0.63|||ANCOVA||Difference in LS Mean|Results are from an ANCOVA model with change from baseline at Week 48 as the response variable and the following fixed effect model terms: treatment (Maraviroc or placebo), baseline value of the response variable, HBV, PI-based regimen.||0.63|-4.31|0.1417
72340453|NCT03007745|144204714|SUPERIORITY||Mean Difference (Net)|-5.94|STANDARD_DEVIATION|6.17|<|0.0001|TWO_SIDED|||||Unadjusted|t-test, 2 sided|Paired t-test comparing baseline and 3-month measures within group (LOCF applied using 1-month data)||Paired t-test comparing baseline and 3-month measures within group (LOCF applied using 1-month data)||||<0.0001
72340454|NCT03007745|144204714|SUPERIORITY|Paired t-test comparing baseline and 3-month measures within group (LOCF applied using 1-month data)|Mean Difference (Final Values)|-5.6|STANDARD_DEVIATION|6.96||0.0001|TWO_SIDED|||||Unadjusted|t-test, 2 sided|||Subjects initiated on CPAP and receiving a 3-month follow-up (LOCF applied using 1-month data)||||0.0001
72340455|NCT03007745|144204714|SUPERIORITY||Mean Difference (Net)|0.01|STANDARD_ERROR_OF_MEAN|1.11||0.9903|TWO_SIDED|||||ANCOVA included main effects for group, site, and the pre-treatment baseline value of the outcome measure|ANCOVA|Adjusted differences in mean changes estimated as site-total-sample-size weighted values controlling for group differences in mean baseline values||Between group comparison of change in Insomnia Severity Index (ISI) at 3 months (LOCF applied using 1-month data)||||0.9903
72340456|NCT03007745|144204718|SUPERIORITY||||||>|0.05|||||||t-test, 2 sided|||Between group comparison of Client Satisfaction Questionnaire (CSQ-8) at 3 months (LOCF applied using 1-month data)||||>0.05
72340457|NCT03007745|144204719|NON_INFERIORITY|The a-priori lower bound selected for the non-inferiority analysis of average daily CPAP use over 3 months was -0.75 hours.|Mean Difference (Final Values)|0.39|STANDARD_ERROR_OF_MEAN|0.37||0.308|TWO_SIDED|||||Group difference (REVAMP - In-person) in mean CPAP daily use over all days adjusted for investigative site.|ANCOVA|The lower bound of the 95% noninferiority confidence interval was -0.22.||||||0.308
72340458|NCT01300351|144204720|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.75||||0.078|TWO_SIDED|95.0|0.54|1.03||With a sample size of 220 randomised patients and 150 progression events, if treatment effect is consistent between ethnicities/the study populations, there is an 89% chance the HR \<1.|Log Rank|||The results of this study would be considered to be consistent with that of the CONFIRM study if the hazard ratio (HR) point estimate for the treatment comparison was \<1 (ie, it favoured fulvestrant 500 mg), without the requirement for the benefit of fulvestrant 500 mg to be statistically significant.||1.03|0.54|0.078
72340459|NCT01300351|144204721|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.44||||0.107|TWO_SIDED|95.0|0.93|2.24|||Regression, Logistic|||||2.24|0.93|0.107
72340460|NCT01300351|144204722|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.37||||0.023|TWO_SIDED|95.0|1.04|1.8|||Regression, Logistic|||||1.80|1.04|0.023
72340461|NCT00385723|144204729|SUPERIORITY_OR_OTHER||Difference in change from baseline|-0.11|STANDARD_ERROR_OF_MEAN|0.04||0.03|TWO_SIDED|95.0|-0.19|-0.028||Bonferroni-adjusted to account for multiple testing.|Mixed Models Analysis||1.25 g/d minus placebo|Comparison was made on change from baseline to 4 months||-0.028|-0.19|0.03
72340462|NCT00385723|144204729|SUPERIORITY_OR_OTHER||Difference in change from baseline|-0.13|STANDARD_ERROR_OF_MEAN|0.04||0.004|TWO_SIDED|95.0|-0.22|-0.052||Bonferroni-adjusted to account for multiple testing.|Mixed Models Analysis||2.5 g/d minus placebo|Comparison was made on the change from baseline to 4 months.||-0.052|-0.22|0.004
72340463|NCT00385723|144204730|SUPERIORITY_OR_OTHER||Difference in change from baseline|-0.41|STANDARD_ERROR_OF_MEAN|0.1||0.0003|TWO_SIDED|95.0|-0.62|-0.21||Bonferroni-adjusted to account for multiple testing.|Mixed Models Analysis||1.25 g/d minus placebo|Comparison was made on change from baseline to 4 months.||-0.21|-0.62|0.0003
72340464|NCT00385723|144204730|SUPERIORITY_OR_OTHER||Difference in change from baseline|-0.43|STANDARD_ERROR_OF_MEAN|0.11||0.0002|TWO_SIDED|95.0|-0.64|-0.22||Bonferroni-adjusted to account for multiple testing.|Mixed Models Analysis||2.5 g/d minus placebo|Comparison was made on the change from baseline to 4 months.||-0.22|-0.64|0.0002
72340465|NCT00385723|144204731|SUPERIORITY_OR_OTHER||Difference in change from baseline|-0.23|STANDARD_ERROR_OF_MEAN|0.21||0.8|TWO_SIDED|95.0|-0.64|0.18||Bonferroni-adjusted to account for multiple testing.|Mixed Models Analysis||1.25 g/d minus placebo|Comparison was made on the change from baseline to 4 months.||0.18|-0.64|0.80
72340466|NCT00385723|144204731|SUPERIORITY_OR_OTHER||Difference in change from baseline|-0.2|STANDARD_ERROR_OF_MEAN|0.21||1|TWO_SIDED|95.0|-0.61|0.21||Bonferroni-adjusted to account for multiple testing.|Mixed Models Analysis||2.5 g/d minus placebo|Comparison was made on the change from baseline to 4 months.||0.21|-0.61|1.0
72340467|NCT00413010|144204732|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.2|STANDARD_ERROR_OF_MEAN|0.48||||95.0|-2.16|-0.26|||Mixed Models Analysis|Adjusted for treatment, pooled center baseline, HAM-A total score,time,and treatment-by time|Since an interim analysis was conducted and the sample size was larger than the targeted 173 subjects per group, a critical t-value adjustment was 1.977, yielding an adjusted 95% CI shown above.|Null hypothesis: no difference between Pregabalin (150-600 mg/day) BID and Placebo BID treatment groups. An initial sample size of 173 subjects per double-blind treatment group was calculated to provide at least 90% power to detect an effect size (ie, difference in the true means between 2 treatment groups/standard deviation) of 0.36 for the HAM-A total score change from Baseline using a 2-sided nominal significance level of 4.9%.||-0.26|-2.16|
72340468|NCT00413010|144204733|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.33|STANDARD_ERROR_OF_MEAN|0.49||||95.0|-2.3|-0.4|||Mixed Models Analysis|Treatment (tx) adjusted, pooled center baseline HAM-A total score,time,and tx-by time. Degrees of freedom adjusted using Satterthwaite approximation|Difference reflects pregabalin minus placebo.|Week 1||-0.4|-2.3|
72340469|NCT00413010|144204733|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-1.04|STANDARD_ERROR_OF_MEAN|0.59||||95.0|-2.2|0.1|||Mixed Models Analysis|Treatment (tx) adjusted, pooled center baseline HAM-A total score,time,and tx-by time. Degrees of freedom adjusted using Satterthwaite approximation|Difference reflects pregabalin minus placebo.|Week 2||0.1|-2.2|
72340470|NCT00413010|144204733|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.45|STANDARD_ERROR_OF_MEAN|0.62||||95.0|-2.7|-0.2|||Mixed Models Analysis|Treatment (tx) adjusted, pooled center baseline HAM-A total score,time,and tx-by time. Degrees of freedom adjusted using Satterthwaite approximation|Difference reflects pregabalin minus placebo.|Week 3||-0.2|-2.7|
72428404|NCT01327547|144367751|SUPERIORITY_OR_OTHER||Difference in LS Mean|-1.44||||0.2679|TWO_SIDED|95.0|-4.01|1.14|||ANCOVA||Difference in LS Mean|Results are from an ANCOVA model with change from baseline at Week 96 as the response variable and the following fixed effect model terms: treatment (Maraviroc or placebo), baseline value of the response variable, HBV, PI-based regimen.||1.14|-4.01|0.2679
72340471|NCT00413010|144204733|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.33|STANDARD_ERROR_OF_MEAN|0.64||||95.0|-2.6|-0.1|||Mixed Models Analysis|Treatment (tx) adjusted, pooled center baseline HAM-A total score,time,and tx-by time. Degrees of freedom adjusted using Satterthwaite approximation|Difference reflects pregabalin minus placebo.|Week 4||-0.1|-2.6|
72340472|NCT00413010|144204733|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.78|STANDARD_ERROR_OF_MEAN|0.68||||95.0|-2.1|0.5|||Mixed Models Analysis|Treatment (tx) adjusted, pooled center baseline HAM-A total score,time,and tx-by time. Degrees of freedom adjusted using Satterthwaite approximation|Difference reflects pregabalin minus placebo.|Week 5||0.5|-2.1|
72340473|NCT00413010|144204733|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.22|STANDARD_ERROR_OF_MEAN|0.67||||95.0|-2.5|0.1|||Mixed Models Analysis|Treatment (tx) adjusted, pooled center baseline HAM-A total score,time,and tx-by time. Degrees of freedom adjusted using Satterthwaite approximation|Difference reflects pregabalin minus placebo.|Week 6||0.1|-2.5|
72340474|NCT00413010|144204733|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.35|STANDARD_ERROR_OF_MEAN|0.77||||95.0|-2.9|0.2|||Mixed Models Analysis|Treatment (tx) adjusted, pooled center baseline HAM-A total score,time,and tx-by time. Degrees of freedom adjusted using Satterthwaite approximation|Difference reflects pregabalin minus placebo.|Week 8||0.2|-2.9|
72340475|NCT00413010|144204734|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|3.35||||||95.0|1.37|8.24||P-value less that the nominal 0.05 level is suggestive of a treatment difference; P-value corresponds to Wald's Chi square test.|Regression, Logistic|Based on fitting a logistic regression on the HAM-A responders at each week with treatment and center in the model.|The odds ratio represented the odds of demonstrating an improvement comparing pregabalin versus placebo. Odds of being a responder (yes) for pregabalin relative to the odds of being a responder for placebo.|Week 1||8.24|1.37|
72340476|NCT00413010|144204734|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.61||||||95.0|0.9|2.87||P-value less than the nominal 0.05 level is suggestive of a treatment difference; P-value corresponds to Wald's Chi square test.|Regression, Logistic|Based on fitting a logistic regression on the HAM-A responsers at each each with treatment and center in the model.|The odds ratio represented the odds of demonstrating an improvement comparing pregabalin versus placebo. Odds of being a responder (yes) for pregabalin relative to the odds of being a responder for placebo.|Week 2||2.87|0.90|
72340477|NCT00413010|144204734|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|3.15||||||95.0|1.76|5.66||P-value less than the nominal 0.05 level is suggestive of a treatment difference; P-value corresponds to Wald's Chi square test.|Regression, Logistic|Based on fitting a logistic regression on the HAM-A responsers at each each with treatment and center in the model.|The odds ratio represented the odds of demonstrating an improvement comparing pregabalin versus placebo. Odds of being a responder (yes) for pregabalin relative to the odds of being a responder for placebo.|Week 3||5.66|1.76|
72340478|NCT00413010|144204734|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.8||||||95.0|1.06|3.05||P-value less than the nominal 0.05 level is suggestive of a treatment difference; P-value corresponds to Wald's Chi square test.|Regression, Logistic|Based on fitting a logistic regression on the HAM-A responsers at each each with treatment and center in the model.|The odds ratio represented the odds of demonstrating an improvement comparing pregabalin versus placebo. Odds of being a responder (yes) for pregabalin relative to the odds of being a responder for placebo.|Week 4||3.05|1.06|
72340479|NCT00413010|144204734|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.57||||||95.0|0.9|2.73||P-value less than the nominal 0.05 level is suggestive of a treatment difference; P-value corresponds to Wald's Chi square test.|Regression, Logistic|Based on fitting a logistic regression on the HAM-A responsers at each each with treatment and center in the model.|The odds ratio represented the odds of demonstrating an improvement comparing pregabalin versus placebo. Odds of being a responder (yes) for pregabalin relative to the odds of being a responder for placebo.|Week 5||2.73|0.90|
72340480|NCT00413010|144204734|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.52||||||95.0|0.86|2.66||P-value less than the nominal 0.05 level is suggestive of a treatment difference; P-value corresponds to Wald's Chi square test.|Regression, Logistic|Based on fitting a logistic regression on the HAM-A responsers at each each with treatment and center in the model.|The odds ratio represented the odds of demonstrating an improvement comparing pregabalin versus placebo. Odds of being a responder (yes) for pregabalin relative to the odds of being a responder for placebo.|Week 6||2.66|0.86|
72340481|NCT00413010|144204734|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.86||||||95.0|1.08|3.22||P-value less than the nominal 0.05 level is suggestive of a treatment difference; P-value corresponds to Wald's Chi square test.|Regression, Logistic|Based on fitting a logistic regression on the HAM-A responsers at each each with treatment and center in the model.|The odds ratio represented the odds of demonstrating an improvement comparing pregabalin versus placebo. Odds of being a responder (yes) for pregabalin relative to the odds of being a responder for placebo.|Week 8||3.22|1.08|
72340482|NCT00413010|144204734|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.77||||||95.0|1.12|2.79||P-value less than the nominal 0.05 level is suggestive of a treatment difference; P-value corresponds to Wald's Chi square test.|Regression, Logistic|Based on fitting a logistic regression on the HAM-A responders at Week 8 (LOCF) with treatment and center in the model.|The odds ratio represented the odds of demonstrating an improvement comparing pregabalin versus placebo. Odds of being a responder (yes) for pregabalin relative to the odds of being a responder for placebo.|Week 8 (last observation carried forward, LOCF)||2.79|1.12|
72340483|NCT00413010|144204735|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.88||||||95.0|0.94|8.8||P-value less that the nominal 0.05 level is suggestive of a treatment difference; P-value corresponds to Wald's Chi square test.|Regression, Logistic|Based on fitting a logistic regression on the HAM-A remission at Week 8 with treatment and center in the model.|The odds ratio represented the odds of demonstrating an improvement comparing pregabalin versus placebo. Odds of being a remitter (yes) for pregabalin relative to the odds of being a remitter for placebo.|Week 1||8.80|0.94|
72340484|NCT00413010|144204735|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.49||||||95.0|0.72|3.06||P-value less that the nominal 0.05 level is suggestive of a treatment difference; P-value corresponds to Wald's Chi square test.|Regression, Logistic|Based on fitting a logistic regression on the HAM-A remission at Week 8 with treatment and center in the model.|The odds ratio represented the odds of demonstrating an improvement comparing pregabalin versus placebo. Odds of being a remitter (yes) for pregabalin relative to the odds of being a remitter for placebo.|Week 2||3.06|0.72|
72340485|NCT00413010|144204735|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.08||||||95.0|1.09|3.97||P-value less that the nominal 0.05 level is suggestive of a treatment difference; P-value corresponds to Wald's Chi square test.|Regression, Logistic|Based on fitting a logistic regression on the HAM-A remission at Week 8 with treatment and center in the model.|The odds ratio represented the odds of demonstrating an improvement comparing pregabalin versus placebo. Odds of being a remitter (yes) for pregabalin relative to the odds of being a remitter for placebo.|Week 3||3.97|1.09|
72340486|NCT00413010|144204735|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.8||||||95.0|0.99|3.28||P-value less that the nominal 0.05 level is suggestive of a treatment difference; P-value corresponds to Wald's Chi square test.|Regression, Logistic|Based on fitting a logistic regression on the HAM-A remission at Week 8 with treatment and center in the model.|The odds ratio represented the odds of demonstrating an improvement comparing pregabalin versus placebo. Odds of being a remitter (yes) for pregabalin relative to the odds of being a remitter for placebo.|Week 4||3.28|0.99|
72340487|NCT00413010|144204735|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.53||||||95.0|0.82|2.85||P-value less that the nominal 0.05 level is suggestive of a treatment difference; P-value corresponds to Wald's Chi square test.|Regression, Logistic|Based on fitting a logistic regression on the HAM-A remission at Week 8 with treatment and center in the model.|The odds ratio represented the odds of demonstrating an improvement comparing pregabalin versus placebo. Odds of being a remitter (yes) for pregabalin relative to the odds of being a remitter for placebo.|Week 5||2.85|0.82|
72340488|NCT00413010|144204735|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.33||||||95.0|0.71|2.48||P-value less that the nominal 0.05 level is suggestive of a treatment difference; P-value corresponds to Wald's Chi square test.|Regression, Logistic|Based on fitting a logistic regression on the HAM-A remission at Week 8 with treatment and center in the model.|The odds ratio represented the odds of demonstrating an improvement comparing pregabalin versus placebo. Odds of being a remitter (yes) for pregabalin relative to the odds of being a remitter for placebo.|Week 6||2.48|0.71|
72340489|NCT00413010|144204735|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.55||||||95.0|0.85|2.83||P-value less that the nominal 0.05 level is suggestive of a treatment difference; P-value corresponds to Wald's Chi square test.|Regression, Logistic|Based on fitting a logistic regression on the HAM-A remission at Week 8 with treatment and center in the model.|The odds ratio represented the odds of demonstrating an improvement comparing pregabalin versus placebo. Odds of being a remitter (yes) for pregabalin relative to the odds of being a remitter for placebo.|Week 8||2.83|0.85|
72340490|NCT00413010|144204735|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.53||||||95.0|0.92|2.53|||Regression, Logistic|Based on fitting a logistic regression on the HAM-A responders at Week 8 (LOCF) with treatment and center in the model.|The odds ratio represented the odds of demonstrating an improvement comparing pregabalin versus placebo. Odds of being a remitter (yes) for pregabalin relative to the odds of being a remitter for placebo.|Week 8 Last Observation Carried Foward (LOCF)||2.53|0.92|
72340491|NCT00413010|144204736|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0137||||||P-value corresponds to the 2-sided log-rank test.|Log Rank|2-sided log-rank test||Kaplan Meier product limit estimate for calculating median time in days to onset sustained HAM-A Improvement.||||0.0137
72340492|NCT00413010|144204737|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.54||||||95.0|0.96|2.47||P-value less than the nominal 0.05 level is suggestive of a treatment difference; P-value corresponds to Wald's Chi square test.|Regression, Logistic|Based on fitting a logistic regression on the CGI-I responders at Week 8 with treatment and center in the model.|The odds ratio represented the odds of demonstrating an improvement comparing pregabalin versus placebo. Odds of being a responder (yes) for pregabalin relative to the odds of being a responder for placebo.|Week 1||2.47|0.96|
72340493|NCT00413010|144204737|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.58||||||95.0|1.01|2.47||P-value less than the nominal 0.05 level is suggestive of a treatment difference; P-value corresponds to Wald's Chi square test.|Regression, Logistic||The odds ratio represented the odds of demonstrating an improvement comparing pregabalin versus placebo. Odds of being a responder (yes) for pregabalin relative to the odds of being a responder for placebo.|Week 2||2.47|1.01|
72340494|NCT00413010|144204737|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.75||||||95.0|1.09|2.82||P-value less than the nominal 0.05 level is suggestive of a treatment difference; P-value corresponds to Wald's Chi square test.|Regression, Logistic||The odds ratio represented the odds of demonstrating an improvement comparing pregabalin versus placebo. Odds of being a responder (yes) for pregabalin relative to the odds of being a responder for placebo.|Week 3||2.82|1.09|
72340495|NCT00413010|144204737|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.26||||||95.0|0.77|2.05||P-value less than the nominal 0.05 level is suggestive of a treatment difference; P-value corresponds to Wald's Chi square test.|Regression, Logistic||The odds ratio represented the odds of demonstrating an improvement comparing pregabalin versus placebo. Odds of being a responder (yes) for pregabalin relative to the odds of being a responder for placebo.|Week 4||2.05|0.77|
72340496|NCT00413010|144204737|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.24||||||95.0|0.72|2.11||P-value less than the nominal 0.05 level is suggestive of a treatment difference; P-value corresponds to Wald's Chi square test.|Regression, Logistic||The odds ratio represented the odds of demonstrating an improvement comparing pregabalin versus placebo. Odds of being a responder (yes) for pregabalin relative to the odds of being a responder for placebo.|Week 5||2.11|0.72|
72340497|NCT00413010|144204737|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.45||||||95.0|0.84|2.5|||Regression, Logistic|P-value less than the nominal 0.05 level is suggestive of a treatment difference; P-value corresponds to Wald's Chi square test.|The odds ratio represented the odds of demonstrating an improvement comparing pregabalin versus placebo. Odds of being a responder (yes) for pregabalin relative to the odds of being a responder for placebo.|Week 6||2.50|0.84|
72340498|NCT00413010|144204737|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.06||||||95.0|0.61|1.84||P-value less than the nominal 0.05 level is suggestive of a treatment difference; P-value corresponds to Wald's Chi square test.|Regression, Logistic||The odds ratio represented the odds of demonstrating an improvement comparing pregabalin versus placebo. Odds of being a responder (yes) for pregabalin relative to the odds of being a responder for placebo.|Week 8||1.84|0.61|
72340499|NCT00413010|144204737|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.12||||||95.0|0.71|1.76||P-value less than the nominal 0.05 level is suggestive of a treatment difference; P-value corresponds to Wald's Chi square test.|Regression, Logistic||The odds ratio represented the odds of demonstrating an improvement comparing pregabalin versus placebo. Odds of being a responder (yes) for pregabalin relative to the odds of being a responder for placebo.|Week 8 (LOCF) Last Observation Carried Forward||1.76|0.71|
72340500|NCT00413010|144204738|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.56||||||95.0|1.07|2.3||P-value less than the nominal 0.05 level is suggestive of a treatment difference; P-value corresponds to Wald's Chi square test.|Cumulative Logit Model|Based on fitting a logistic regression model for ordinal response of CGI-S scores at Week 8 (LOCF) with treatment and center in the model.|The odds ratio represented the odds of demonstrating an improvement comparing pregabalin versus placebo. The odds of having an increasingly better response for pregabalin relative to the odds of having an increasingly better response for placebo.|Week 8 Last Observation Carried Forward (LOCF)||2.30|1.07|
72340501|NCT00413010|144204739|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.8||||||95.0|-1.5|0.0|||ANCOVA|Repeated analysis of covariance heterogeneous auto-regressive w/ tx center wk \& tx by wk fixed effects; Baseline HAM-D total score covariate in model.|Difference is pregabalin minus placebo.|Week 1||0.0|-1.5|
72340502|NCT00413010|144204739|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.6||||||95.0|-1.5|0.2|||ANCOVA|Repeated analysis of covariance heterogeneous auto-regressive w/ tx center wk \& tx by wk fixed effects; Baseline HAM-D total score covariate in model.|Difference is pregabalin minus placebo.|Week 2||0.2|-1.5|
72340503|NCT00413010|144204739|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.7||||||95.0|-1.6|0.1|||ANCOVA|Repeated analysis of covariance heterogeneous auto-regressive w/ tx center wk \& tx by wk fixed effects; Baseline HAM-D total score covariate in model.|Difference is pregabalin minus placebo.|Week 3||0.1|-1.6|
72340504|NCT00413010|144204739|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.3||||||95.0|-2.1|-0.6|||ANCOVA|Repeated analysis of covariance heterogeneous auto-regressive w/ tx center wk \& tx by wk fixed effects; Baseline HAM-D total score covariate in model.|Difference is pregabalin minus placebo.|Week 4||-0.6|-2.1|
72340505|NCT00413010|144204739|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.4||||||95.0|-1.3|0.5|||ANCOVA|Repeated analysis of covariance heterogeneous auto-regressive w/ tx center wk \& tx by wk fixed effects; Baseline HAM-D total score covariate in model.|Difference is pregabalin minus placebo.|Week 5||0.5|-1.3|
72340506|NCT00413010|144204739|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.9||||||95.0|-1.8|0.0|||ANCOVA|Repeated analysis of covariance heterogeneous auto-regressive w/ tx center wk \& tx by wk fixed effects; Baseline HAM-D total score covariate in model.|Difference is pregabalin minus placebo.|Week 6||0.0|-1.8|
72340507|NCT00413010|144204739|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.0||||||95.0|-2.1|0.1|||ANCOVA|Repeated analysis of covariance heterogeneous auto-regressive w/ tx center wk \& tx by wk fixed effects; Baseline HAM-D total score covariate in model.|Difference is pregabalin minus placebo.|Week 8||0.1|-2.1|
72340508|NCT01189292|144204740|SUPERIORITY_OR_OTHER||Risk Difference (RD)|28.0||||0.001|TWO_SIDED|95.0|12.0|42.0|||Chi-squared|||null hypothesis: Incidence of PONV is the same in both treatment arms||42|12|0.001
72340509|NCT01189292|144204741|SUPERIORITY_OR_OTHER||Risk Difference (RD)|24.0||||0.006|TWO_SIDED|95.0|7.0|40.0|||Chi-squared|||per protocol analysis||40|7|0.006
72340510|NCT01189292|144204744|SUPERIORITY_OR_OTHER|||||||0.674|TWO_SIDED||||||Mixed Models Analysis|mixed model over the mean ranks at all time points measured (4, 8, 16, 24, 32, 48 hours)||||||0.674
72340511|NCT01189292|144204745|SUPERIORITY_OR_OTHER|||||||0.835|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.835
72340512|NCT01533922|144204750|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.244|STANDARD_ERROR_OF_MEAN|0.027|<|0.0001|TWO_SIDED|95.0|0.191|0.298|||Mixed Models Analysis||Difference calculated as Tiotropium + olodaterol 5/5 once daily (QD) minus Placebo|||0.298|0.191|<0.0001
72340513|NCT01533922|144204750|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.119|STANDARD_ERROR_OF_MEAN|0.027|<|0.0001|TWO_SIDED|95.0|0.065|0.172|||Mixed Models Analysis||Difference calculated as Tiotropium + olodaterol 5/5 QD minus Olodaterol 5 mcg|||0.172|0.065|<0.0001
72340514|NCT01533922|144204750|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.114|STANDARD_ERROR_OF_MEAN|0.027|<|0.0001|TWO_SIDED|95.0|0.061|0.167|||Mixed Models Analysis||Difference calculated as Tiotropium + olodaterol 5/5 QD minus Tiotropium 5 mcg QD|||0.167|0.061|<0.0001
72340515|NCT01533922|144204750|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.218|STANDARD_ERROR_OF_MEAN|0.027|<|0.0001|TWO_SIDED|95.0|0.164|0.271|||Mixed Models Analysis||Difference calculated as Tiotropium + olodaterol 2.5/5 QD minus Placebo QD|||0.271|0.164|<0.0001
72340516|NCT01533922|144204750|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.092|STANDARD_ERROR_OF_MEAN|0.027||0.0008|TWO_SIDED|95.0|0.038|0.145|||Mixed Models Analysis||Difference calculated as Tiotropium + olodaterol 2.5/5 QD minus Olodaterol 5 mcg QD|||0.145|0.038|0.0008
72340517|NCT01533922|144204750|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.087|STANDARD_ERROR_OF_MEAN|0.027||0.0015|TWO_SIDED|95.0|0.034|0.141|||Mixed Models Analysis||Difference calculated as Tiotropium + olodaterol 2.5/5 QD minus Tiotropium 5 mcg QD|||0.141|0.034|0.0015
72340518|NCT01533922|144204751|SUPERIORITY_OR_OTHER||Ratio|1.209|STANDARD_ERROR_OF_MEAN|0.041|<|0.0001|TWO_SIDED|95.0|1.132|1.292|||Mixed Models Analysis||Ratio calculated as Tiotropium + olodaterol 5/5 QD divided by Placebo QD|||1.292|1.132|<0.0001
72340519|NCT01533922|144204751|SUPERIORITY_OR_OTHER||Ratio|1.002|STANDARD_ERROR_OF_MEAN|0.034||0.9633|TWO_SIDED|95.0|0.937|1.07|||Mixed Models Analysis||Ratio calculated as Tiotropium + olodaterol 5/5 QD divided by Olodaterol 5 mcg QD|||1.070|0.937|0.9633
72340520|NCT01533922|144204751|SUPERIORITY_OR_OTHER||Ratio|0.993|STANDARD_ERROR_OF_MEAN|0.033||0.8415|TWO_SIDED|95.0|0.93|1.061|||Mixed Models Analysis||Ratio calculated as Tiotropium + olodaterol 5/5 QD divided by Tiotropium 5 mcg QD|||1.061|0.930|0.8415
72428405|NCT01327547|144367751|SUPERIORITY_OR_OTHER||Difference in LS Mean|-1.48||||0.1366|TWO_SIDED|95.0|-3.45|0.49|||ANCOVA||Difference in LS Mean|Results are from an ANCOVA model with change from baseline at Week 144 as the response variable and the following fixed effect model terms: treatment (Maraviroc or placebo), baseline value of the response variable, HBV, PI-based regimen.||0.49|-3.45|0.1366
72428406|NCT02291289|144367763|SUPERIORITY||Hazard Ratio (HR)|0.95|||=|0.872|TWO_SIDED|95.0|0.5|1.82|||Log Rank|||||1.82|0.50|= 0.872
72340521|NCT01533922|144204751|SUPERIORITY_OR_OTHER||Ratio|1.265|STANDARD_ERROR_OF_MEAN|0.042|<|0.0001|TWO_SIDED|95.0|1.184|1.351|||Mixed Models Analysis||Ratio calculated as Tiotropium + olodaterol 2.5/5 QD divided by Placebo QD|||1.351|1.184|<0.0001
72428407|NCT02291289|144367763|SUPERIORITY||Hazard Ratio (HR)|0.95|||=|0.666|TWO_SIDED|95.0|0.77|1.18|||Log Rank|||||1.18|0.77|= 0.666
72428408|NCT02291289|144367763|SUPERIORITY||Hazard Ratio (HR)|1.44|||=|0.128|TWO_SIDED|95.0|0.9|2.29|||Log Rank|||||2.29|0.90|= 0.128
72428409|NCT02291289|144367764|SUPERIORITY||Hazard Ratio (HR)|0.71|||=|0.276|TWO_SIDED|95.0|0.39|1.32|||Log Rank|||||1.32|0.39|= 0.276
72340522|NCT01533922|144204751|SUPERIORITY_OR_OTHER||Ratio|1.047|STANDARD_ERROR_OF_MEAN|0.035||0.1717|TWO_SIDED|95.0|0.98|1.119|||Mixed Models Analysis||Ratio calculated as Tiotropium + olodaterol 2.5/5 QD divided by Olodaterol 5 mcg QD|||1.119|0.980|0.1717
72340523|NCT01533922|144204751|SUPERIORITY_OR_OTHER||Ratio|1.039|STANDARD_ERROR_OF_MEAN|0.035||0.261|TWO_SIDED|95.0|0.972|1.11|||Mixed Models Analysis||Ratio calculated asTiotropium + olodaterol 2.5/5 QD divided by Tiotropium 5 mcg QD|||1.110|0.972|0.2610
72340524|NCT01533922|144204752|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.003|STANDARD_ERROR_OF_MEAN|0.001||0.0004|TWO_SIDED|95.0|-0.004|-0.001|||Mixed Models Analysis||Difference calculated as Tiotropium + olodaterol 5/5 QD minus Placebo QD|||-0.001|-0.004|0.0004
72340525|NCT01533922|144204752|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.001||0.8291|TWO_SIDED|95.0|-0.001|0.002|||Mixed Models Analysis||Difference calculated as Tiotropium + olodaterol 5/5 QD minus Olodaterol 5 mcg QD|||0.002|-0.001|0.8291
72340526|NCT01533922|144204752|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.001||0.857|TWO_SIDED|95.0|-0.002|0.001|||Mixed Models Analysis||Difference calculated as Tiotropium + olodaterol 5/5 QD minus Tiotropium 5 mcg QD|||0.001|-0.002|0.8570
72340527|NCT01533922|144204752|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.003|STANDARD_ERROR_OF_MEAN|0.001|<|0.0001|TWO_SIDED|95.0|-0.005|-0.002|||Mixed Models Analysis||Difference calculated as Tiotropium + olodaterol 2.5/5 QD minus Placebo QD|||-0.002|-0.005|<0.0001
72340528|NCT01533922|144204752|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.001||0.7294|TWO_SIDED|95.0|-0.002|0.001|||Mixed Models Analysis||Difference calculated as Tiotropium + olodaterol 2.5/5 QD minus Olodaterol 5 mcg QD|||0.001|-0.002|0.7294
72340529|NCT01533922|144204752|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.001|STANDARD_ERROR_OF_MEAN|0.001||0.4567|TWO_SIDED|95.0|-0.002|0.001|||Mixed Models Analysis||Difference calculated as Tiotropium + olodaterol 2.5/5 QD minus Tiotropium 5 mcg QD|||0.001|-0.002|0.4567
72340530|NCT01533922|144204753|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.323|STANDARD_ERROR_OF_MEAN|0.015|<|0.0001|TWO_SIDED|95.0|0.293|0.352|||Mixed Models Analysis||Difference calculated as Tiotropium + olodaterol 5/5 QD minus Placebo QD|||0.352|0.293|<0.0001
72340531|NCT01533922|144204753|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.13|STANDARD_ERROR_OF_MEAN|0.015|<|0.0001|TWO_SIDED|95.0|0.101|0.16|||Mixed Models Analysis||Difference calculated as Tiotropium + olodaterol 5/5 QD minus Olodaterol 5 mcg QD|||0.160|0.101|<0.0001
72340532|NCT01533922|144204753|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.114|STANDARD_ERROR_OF_MEAN|0.015|<|0.0001|TWO_SIDED|95.0|0.084|0.143|||Mixed Models Analysis||Difference calculated as Tiotropium + olodaterol 5/5 QD minus Tiotropium 5 mcg QD|||0.143|0.084|<0.0001
72428410|NCT02291289|144367764|SUPERIORITY||Hazard Ratio (HR)|0.81|||=|0.076|TWO_SIDED|95.0|0.64|1.02|||Log Rank|||||1.02|0.64|= 0.076
72428411|NCT02291289|144367764|SUPERIORITY||||||=|0.157|||||||Log Rank|||||||= 0.157
72340533|NCT01533922|144204753|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.286|STANDARD_ERROR_OF_MEAN|0.015|<|0.0001|TWO_SIDED|95.0|0.256|0.315|||Mixed Models Analysis||Difference calculated as Tiotropium + olodaterol 2.5/5 QD minus Placebo QD|||0.315|0.256|<0.0001
72340534|NCT01533922|144204753|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.093|STANDARD_ERROR_OF_MEAN|0.015|<|0.0001|TWO_SIDED|95.0|0.063|0.123|||Mixed Models Analysis||Difference calculated as Tiotropium + olodaterol 2.5/5 QD minus Olodaterol 5 mcg QD|||0.123|0.063|<0.0001
72340535|NCT01533922|144204753|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.077|STANDARD_ERROR_OF_MEAN|0.015|<|0.0001|TWO_SIDED|95.0|0.047|0.106|||Mixed Models Analysis||Difference calculated as Tiotropium + olodaterol 2.5/5 QD minus Tiotropium 5 mcg QD|||0.106|0.047|<0.0001
72340536|NCT02553538|144204758|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
72340537|NCT02553538|144204759|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Regression, Logistic|||||||<0.001
72340538|NCT02553538|144204760|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Regression, Logistic|||||||<0.001
72340539|NCT02553538|144204761|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
72340540|NCT00357656|144204783|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority by the 200% margin of non-inferiority was demonstrated if the upper confidence limit of a 95% 2-sided confidence interval for the ratio of means did not exceed 200%.|Mean ratio CI/BI|0.924||||0.001|TWO_SIDED|95.0|0.816|1.046||one-sided p-value against the null hypothesis of ration \>=200%|Hypothesis test|||The main analysis used a point estimate and a two-sided 95% confidence interval for ratio of the primary outcome measure of CI over BI combined over the three strata: stratum A: unilateral knee replacement, stratum B: hip surgery, stratum C: shoulder/elbow/ankle/knee (except knee replacement) surgery.||1.046|0.816|0.001
72340541|NCT00121641|144204821|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.62|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-0.9|-0.33||Between-group comparisons significant at alpha = 0.019, significance testing based on hierarchical testing. Primary and secondary endpoints are presented in order of testing.|ANCOVA|Adjusted mean difference for saxagliptin groups vs placebo in Week 24 (LOCF). Adjusted for baseline.|ANCOVA model:post - pre = pre treatment|||-0.33|-0.90|<.0001
72340542|NCT00121641|144204821|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.64|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-0.93|-0.36||Between-group comparisons significant at alpha = 0.019, significance testing based on hierarchical testing. Primary and secondary endpoints are presented in order of testing.|ANCOVA|Adjusted mean difference for saxagliptin groups vs placebo in Week 24 (LOCF). Adjusted for baseline.|ANCOVA model:post - pre = pre treatment|||-0.36|-0.93|<.0001
72340543|NCT00121641|144204821|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.73|STANDARD_ERROR_OF_MEAN|0.15|<|0.0001|TWO_SIDED|95.0|-1.02|-0.44||Between-group comparisons significant at alpha = 0.019, significance testing based on hierarchical testing. Primary and secondary endpoints are presented in order of testing.|ANCOVA|Adjusted mean difference for saxagliptin groups vs placebo in Week 24 (LOCF). Adjusted for baseline.|ANCOVA model:post - pre = pre treatment|||-0.44|-1.02|<.0001
72428412|NCT02291289|144367764|SUPERIORITY||Hazard Ratio (HR)|1.25|||=|0.415|TWO_SIDED|95.0|0.73|2.14|||Log Rank|||||2.14|0.73|= 0.415
72428413|NCT02291289|144367766|SUPERIORITY||||||=|0.064|||||||Chi-squared|||||||= 0.064
72428414|NCT02291289|144367766|SUPERIORITY||||||=|0.658|||||||Chi-squared|||||||= 0.658
72340544|NCT00121641|144204822|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-20.6|STANDARD_ERROR_OF_MEAN|5.53||0.0002|TWO_SIDED|95.0|-31.47|-9.72||Significance testing based on hierarchical testing. Primary and secondary endpoints are presented in order of testing.|ANCOVA|Adjusted mean difference for saxagliptin groups vs placebo in Week 24 (LOCF). Adjusted for baseline.|ANCOVA model:post - pre = pre treatment|||-9.72|-31.47|0.0002
72340545|NCT00121641|144204822|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.73|STANDARD_ERROR_OF_MEAN|5.48||0.0074|TWO_SIDED|95.0|-25.5|-3.97||Significance testing based on hierarchical testing. Primary and secondary endpoints are presented in order of testing.|ANCOVA|Adjusted mean difference for saxagliptin groups vs placebo in Week 24 (LOCF). Adjusted for baseline.|ANCOVA model:post - pre = pre treatment|||-3.97|-25.50|0.0074
72340546|NCT00121641|144204822|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-22.81|STANDARD_ERROR_OF_MEAN|5.58|<|0.0001|TWO_SIDED|95.0|-33.79|-11.84||Significance testing based on hierarchical testing. Primary and secondary endpoints are presented in order of testing.|ANCOVA|Adjusted mean difference for saxagliptin groups vs placebo in Week 24 (LOCF). Adjusted for baseline.|ANCOVA model:post - pre = pre treatment|||-11.84|-33.79|<.0001
72340547|NCT00121641|144204823|SUPERIORITY_OR_OTHER||Difference in Proportions|11.1||||0.1141|TWO_SIDED|95.0|-3.1|24.9||Significance testing based on hierarchical testing. Primary and secondary endpoints are presented in order of testing.|Fisher Exact|The exact 95% CIs is based on the standardized statistic and inverting the one 2-sided test.||||24.9|-3.1|0.1141
72340548|NCT00121641|144204823|SUPERIORITY_OR_OTHER||Difference in Proportions|14.0||||0.0443|TWO_SIDED|95.0|-0.1|27.6||Significance testing based on hierarchical testing. Primary and secondary endpoints are presented in order of testing.|Fisher Exact|The exact 95% CIs is based on the standardized statistic and inverting the one 2-sided test.||||27.6|-0.1|0.0443
72340549|NCT00121641|144204823|SUPERIORITY_OR_OTHER||Difference in Proportions|17.1||||0.0133|TWO_SIDED|95.0|2.8|31.0||Significance testing based on hierarchical testing. Primary and secondary endpoints are presented in order of testing.|Fisher Exact|The exact 95% CIs is based on the standardized statistic and inverting the one 2-sided test.||||31.0|2.8|0.0133
72340550|NCT00121641|144204824|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6221.0|STANDARD_ERROR_OF_MEAN|1701.3||0.0003|TWO_SIDED|95.0|-9570.0|-2872.0||Significance testing based on hierarchical testing. Primary and secondary endpoints are presented in order of testing.|ANCOVA|Adjusted mean difference for saxagliptin groups vs placebo in Week 24 (LOCF). Adjusted for baseline.|ANCOVA model:post - pre = pre treatment|||-2872|-9570|0.0003
72340551|NCT00121641|144204824|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6249.0|STANDARD_ERROR_OF_MEAN|1675.1||0.0002|TWO_SIDED|95.0|-9546.0|-2952.0||Significance testing based on hierarchical testing. Primary and secondary endpoints are presented in order of testing.|ANCOVA|Adjusted mean difference for saxagliptin groups vs placebo in Week 24 (LOCF). Adjusted for baseline.|ANCOVA model:post - pre = pre treatment|||-2952|-9546|0.0002
72428415|NCT02291289|144367766|SUPERIORITY|||||||0.093|||||||Chi-squared|||||||0.093
72428416|NCT02291289|144367767|SUPERIORITY||||||=|0.125|||||||Chi-squared|||||||= 0.125
72428417|NCT02291289|144367767|SUPERIORITY||||||=|0.739|||||||Chi-squared|||||||= 0.739
72428418|NCT02291289|144367767|SUPERIORITY|||||||0.362|||||||Chi-squared|||||||0.362
72340552|NCT00121641|144204824|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7437.0|STANDARD_ERROR_OF_MEAN|1707.6|<|0.0001|TWO_SIDED|95.0|-10798.0|-4076.0||Significance testing based on hierarchical testing. Primary and secondary endpoints are presented in order of testing.|ANCOVA|Adjusted mean difference for saxagliptin groups vs placebo in Week 24 (LOCF). Adjusted for baseline.|ANCOVA model:post - pre = pre treatment|||-4076|-10798|<.0001
72340553|NCT00249613|144204866|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.4|STANDARD_ERROR_OF_MEAN|0.34||0.01|TWO_SIDED|95.0|0.21|0.79||Odds ratio is 0.40, confidence interval is 0.21-0.79.|Regression, Logistic||The direction of the comparison would dictate that odds ratio of less than 1 would indicate Women-Only participants are less likely than Mixed-Gender participants to engage in criminal activities.|Logistic regression does not separate arms because group status (women-only vs mixed gender) is the dependent variable in our multinomial logistic regression. Because we were not able to randomly assign after all, we also included a propensity score, and additional variables (substance use in past 30 days at baseline, age, race/ethnicity, childhood sexual abuse history, previous treatment, criminal justice funding source, and primary drug) to adjust for the non-random sampling.||0.79|0.21|0.01
72340554|NCT00249613|144204867|SUPERIORITY_OR_OTHER||Beta coefficient|-0.7|STANDARD_ERROR_OF_MEAN|0.72||0.33|TWO_SIDED|95.0|-2.11|0.7|||Generalized estimating equations (GEE)|||Generalized estimating equation (GEE) models do not separate arms: group status (women-only vs mixed-gender) is the dependent variable. Because we were not able to randomly assign, we also included a propensity score, and additional variables (education, race/ethnicity, marital status, income, history of sexual abuse, criminal justice funding source, had child, mental health symptoms, and a time in treatment by group interaction term) to adjust for the non-random sampling.||0.70|-2.11|0.33
72340555|NCT00249613|144204868|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.42|STANDARD_ERROR_OF_MEAN|0.34||0.01|TWO_SIDED|95.0|0.22|0.82|||Regression, Logistic||The direction of the comparison would dictate that odds ratio of less than 1 would indicate Women-Only treatment participants are less likely than the Mixed-Gender group to use drugs or alcohol during the 30 days prior to the 12-Mo follow-up.|Logistic regression does not separate arms because group status (women-only vs mixed gender) is the dependent variable in our multinomial logistic regression. Because we were not able to randomly assign after all, we also included a propensity score, and additional variables (substance use in past 30 days at baseline, age, race/ethnicity, childhood sexual abuse history, previous treatment, criminal justice funding source, and primary drug) to adjust for the non-random sampling.||0.82|0.22|0.01
72340556|NCT01184417|144204877|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|17.0|||||TWO_SIDED|95.0|4.0|32.0||||||||32|4|
72340557|NCT01184417|144204878|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|23.0|||||TWO_SIDED|95.0|4.0|49.0||||||||49|4|
72340558|NCT01184417|144204879|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|42.0|||||TWO_SIDED|95.0|-4.0|82.0||||||||82|-4|
72340559|NCT01184417|144204881|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.0|||||TWO_SIDED|95.0|-11.0|23.0||||||||23|-11|
72340560|NCT01355796|144204884|SUPERIORITY||Mean Difference (Net)|1.49|STANDARD_ERROR_OF_MEAN|1.66|<|0.05|TWO_SIDED|95.0|-1.76|4.75|||Mixed Models Analysis|||||4.75|-1.76|<0.05
72340561|NCT01264770|144204900|SUPERIORITY_OR_OTHER||Treatment difference|0.56||||0.006|TWO_SIDED|90.0|0.23|0.9|||ANCOVA|Includes terms for baseline as a continuous covariate and treatment, DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country as factors.||Change from baseline at Week 6. Non-responder imputation applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of parenteral steroids, or for patients with no post baseline data.||0.90|0.23|0.006
72340562|NCT01264770|144204900|SUPERIORITY_OR_OTHER||Treatment difference|0.49||||0.022|TWO_SIDED|90.0|0.14|0.84|||ANCOVA|Includes terms for baseline as a continuous covariate and treatment, DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country as factors.||Change from baseline at Week 6. Non-responder imputation applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of parenteral steroids, or for patients with no post baseline data.||0.84|0.14|0.022
72340563|NCT01264770|144204900|SUPERIORITY_OR_OTHER||Treatment difference|0.22||||0.28|TWO_SIDED|90.0|-0.12|0.56|||ANCOVA|Includes terms for baseline as a continuous covariate and treatment, DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country as factors.||Change from baseline at Week 6. Non-responder imputation applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of parenteral steroids, or for patients with no post baseline data.||0.56|-0.12|0.280
72340564|NCT01264770|144204901|NON_INFERIORITY_OR_EQUIVALENCE|For the comparison with adalimumab a non-inferiority margin of -0.6 in the mean change from baseline in DAS28-CRP at Week 24 was defined. The lower 80% confidence interval for treatment difference was below this value so non-inferiority could not be concluded. A p-value is also provided for a 2-sided test of superiority.|Treatment difference|-0.72||||0.005|TWO_SIDED|80.0|-1.04|-0.4|||ANCOVA|Includes terms for baseline as a continuous covariate and treatment, DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country as factors.||Change from baseline at Week 24. Non-responder imputation applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of parenteral steroids, or for patients with no post baseline data.||-0.40|-1.04|0.005
72340565|NCT01264770|144204901|NON_INFERIORITY_OR_EQUIVALENCE|For the comparison with adalimumab a non-inferiority margin of -0.6 in the mean change from baseline in DAS28-CRP at Week 24 was defined. The lower 80% confidence interval for treatment difference was below this value so non-inferiority could not be concluded. A p-value is also provided for a 2-sided test of superiority.|Treatment difference|-0.61||||0.02|TWO_SIDED|80.0|-0.94|-0.27|||ANCOVA|Includes terms for baseline as a continuous covariate and treatment, DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country as factors.||Change from baseline at Week 24. Non-responder imputation applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of parenteral steroids, or for patients with no post baseline data.||-0.27|-0.94|0.020
72368378|NCT00298558|144246916|SUPERIORITY_OR_OTHER||Effect Size|-0.05||||0.52|TWO_SIDED|99.0|-0.25|0.15|||Mixed Models Analysis|The blom transformation was used to reduce skewness in the measures. The design factors and baseline covariates were controlled in the model.|Blom transformed outcome was used and the design factors and baseline covariates were controlled in the model to get the adjusted means. After that, the effect size (defined in the Additional details) was calculated using the adjusted means and SD.|Effect size was defined as training improvement from baseline to year 10 minus control improvement from baseline to year 10 divided by the intrasubject standard deviation (SD) of the composite score. Positive effect sizes indicate improvement.||0.15|-0.25|0.52
72340566|NCT01264770|144204901|NON_INFERIORITY_OR_EQUIVALENCE|For the comparison with adalimumab a non-inferiority margin of -0.6 in the mean change from baseline in DAS28-CRP at Week 24 was defined. The lower 80% confidence interval for treatment difference was below this value so non-inferiority could not be concluded. A p-value is also provided for a 2-sided test of superiority.|Treatment difference|-0.72||||0.004|TWO_SIDED|80.0|-1.04|-0.4|||ANCOVA|Includes terms for baseline as a continuous covariate and treatment, DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country as factors.||Change from baseline at Week 24. Non-responder imputation applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of parenteral steroids, or for patients with no post baseline data.||-0.40|-1.04|0.004
72340567|NCT01264770|144204902|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.05||||0.005|TWO_SIDED|90.0|1.59|5.86|||Proportional odds model||An odds ratio \>1 indicates a benefit towards fostamatinib.|Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||5.86|1.59|0.005
72340568|NCT01264770|144204902|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.11|||<|0.001|TWO_SIDED|90.0|2.1|8.05|||Proportional odds model||An odds ratio \>1 indicates a benefit towards fostamatinib.|Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||8.05|2.10|<0.001
72340569|NCT01264770|144204902|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.47||||0.335|TWO_SIDED|90.0|0.76|2.83|||Proportional odds model||An odds ratio \>1 indicates a benefit towards fostamatinib.|Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||2.83|0.76|0.335
72340570|NCT01264770|144204903|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.37||||0.007|TWO_SIDED|90.0|0.2|0.68|||Proportional odds model||An odds ratio \>1 indicates a benefit towards fostamatinib.|Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||0.68|0.20|0.007
72340571|NCT01264770|144204903|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.48||||0.051|TWO_SIDED|90.0|0.26|0.89|||Proportional odds model||An odds ratio \>1 indicates a benefit towards fostamatinib.|Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||0.89|0.26|0.051
72340572|NCT01264770|144204903|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.36||||0.004|TWO_SIDED|90.0|0.2|0.65|||Proportional odds model||An odds ratio \>1 indicates a benefit towards fostamatinib.|Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||0.65|0.20|0.004
72340573|NCT01264770|144204904|SUPERIORITY_OR_OTHER||Weighted difference in proportions|0.29|||<|0.001|TWO_SIDED|90.0|0.17|0.4||Week 6|Mantel Haenszel|p-values are calculated using a Mantel-Haenszel approach stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.|90% confidence intervals are calculated using a Mantel-Haenszel approach stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.|Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||0.40|0.17|<0.001
72340574|NCT01264770|144204904|SUPERIORITY_OR_OTHER||Weighted difference in proportions|0.3|||<|0.001|TWO_SIDED|90.0|0.18|0.43||Week 6|Mantel Haenszel|p-values are calculated using a Mantel-Haenszel approach stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.|90% confidence intervals are calculated using a Mantel-Haenszel approach stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.|Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||0.43|0.18|<0.001
72340575|NCT01264770|144204904|SUPERIORITY_OR_OTHER||Weighted difference in proportions|0.19||||0.007|TWO_SIDED|90.0|0.07|0.31||Week 6|Mantel Haenszel|p-values are calculated using a Mantel-Haenszel approach stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.|90% confidence intervals are calculated using a Mantel-Haenszel approach stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.|Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||0.31|0.07|0.007
72340576|NCT01264770|144204904|SUPERIORITY_OR_OTHER||Weighted difference in proportions|-0.16||||0.049|TWO_SIDED|90.0|-0.3|-0.03||Week 24|Mantel Haenszel|p-values are calculated using a Mantel-Haenszel approach stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.|90% confidence intervals are calculated using a Mantel-Haenszel approach stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.|Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||-0.03|-0.30|0.049
72428419|NCT02291289|144367769|SUPERIORITY||||||=|0.421|||||||Log Rank|||||||= 0.421
72340577|NCT01264770|144204904|SUPERIORITY_OR_OTHER||Weighted difference in proportions|-0.02||||0.803|TWO_SIDED|90.0|-0.16|0.12||Week 24|Mantel Haenszel|p-values are calculated using a Mantel-Haenszel approach stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.|90% confidence intervals are calculated using a Mantel-Haenszel approach stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.|Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||0.12|-0.16|0.803
72340578|NCT01264770|144204904|SUPERIORITY_OR_OTHER||Weighted difference in proportions|-0.24||||0.003|TWO_SIDED|90.0|-0.37|-0.1||Week 24|Mantel Haenszel|p-values are calculated using a Mantel-Haenszel approach stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.|90% confidence intervals are calculated using a Mantel-Haenszel approach stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.|Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||-0.10|-0.37|0.003
72428420|NCT02291289|144367769|SUPERIORITY||||||=|0.495|||||||Log Rank|||||||= 0.495
72340579|NCT01264770|144204905|SUPERIORITY_OR_OTHER||Weighted difference in proportions|0.09||||0.059|TWO_SIDED|90.0|0.01|0.18||Week 6|Mantel Haenszel|p-values are calculated using a Mantel-Haenszel approach stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.|90% confidence intervals are calculated using a Mantel-Haenszel approach stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.|Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||0.18|0.01|0.059
72340580|NCT01264770|144204905|SUPERIORITY_OR_OTHER||Weighted difference in proportions|0.09||||0.071|TWO_SIDED|90.0|0.01|0.17||Week 6|Mantel Haenszel|p-values are calculated using a Mantel-Haenszel approach stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.|90% confidence intervals are calculated using a Mantel-Haenszel approach stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.|Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||0.17|0.01|0.071
72340581|NCT01264770|144204905|SUPERIORITY_OR_OTHER||Weighted difference in proportions|0.01||||0.758|TWO_SIDED|90.0|-0.05|0.07||Week 6|Mantel Haenszel|p-values are calculated using a Mantel-Haenszel approach stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.|90% confidence intervals are calculated using a Mantel-Haenszel approach stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.|Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||0.07|-0.05|0.758
72340582|NCT01264770|144204905|SUPERIORITY_OR_OTHER||Weighted difference in proportions|-0.12||||0.114|TWO_SIDED|90.0|-0.24|0.0||Week 24|Mantel Haenszel|p-values are calculated using a Mantel-Haenszel approach stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.|90% confidence intervals are calculated using a Mantel-Haenszel approach stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.|Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||0.00|-0.24|0.114
72340583|NCT01264770|144204905|SUPERIORITY_OR_OTHER||Weighted difference in proportions|-0.14||||0.078|TWO_SIDED|90.0|-0.26|-0.01||Week 24|Mantel Haenszel|p-values are calculated using a Mantel-Haenszel approach stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.|90% confidence intervals are calculated using a Mantel-Haenszel approach stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.|Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||-0.01|-0.26|0.078
72340584|NCT01264770|144204905|SUPERIORITY_OR_OTHER||Weighted difference in proportions|-0.21||||0.003|TWO_SIDED|90.0|-0.32|-0.09||Week 24|Mantel Haenszel|p-values are calculated using a Mantel-Haenszel approach stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.|90% confidence intervals are calculated using a Mantel-Haenszel approach stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.|Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||-0.09|-0.32|0.003
72340585|NCT01264770|144204906|SUPERIORITY_OR_OTHER||Weighted difference in proportions|-0.02||||0.46|TWO_SIDED|90.0|-0.07|0.03||Week 6|Mantel Haenszel|p-values are calculated using a Mantel-Haenszel approach stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.|90% confidence intervals are calculated using a Mantel-Haenszel approach stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.|Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||0.03|-0.07|0.460
72340586|NCT01264770|144204906|SUPERIORITY_OR_OTHER||Weighted difference in proportions|0.0||||0.903|TWO_SIDED|90.0|-0.05|0.06||Week 6|Mantel Haenszel|p-values are calculated using a Mantel-Haenszel approach stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.|90% confidence intervals are calculated using a Mantel-Haenszel approach stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.|Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||0.06|-0.05|0.903
72340587|NCT01264770|144204906|SUPERIORITY_OR_OTHER||Weighted difference in proportions|-0.03||||0.172|TWO_SIDED|90.0|-0.08|0.01||Week 6|Mantel Haenszel|p-values are calculated using a Mantel-Haenszel approach stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.|90% confidence intervals are calculated using a Mantel-Haenszel approach stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.|Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||0.01|-0.08|0.172
72340588|NCT01264770|144204906|SUPERIORITY_OR_OTHER||Weighted difference in proportions|-0.11||||0.082|TWO_SIDED|90.0|-0.21|-0.01||Week 24|Mantel Haenszel|p-values are calculated using a Mantel-Haenszel approach stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.|90% confidence intervals are calculated using a Mantel-Haenszel approach stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.|Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||-0.01|-0.21|0.082
72340589|NCT01264770|144204906|SUPERIORITY_OR_OTHER||Weighted difference in proportions|-0.11||||0.092|TWO_SIDED|90.0|-0.21|0.0||Week 24|Mantel Haenszel|p-values are calculated using a Mantel-Haenszel approach stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.|90% confidence intervals are calculated using a Mantel-Haenszel approach stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.|Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||-0.00|-0.21|0.092
72428421|NCT02291289|144367769|SUPERIORITY|||||||0.357|||||||Log Rank|||||||0.357
72340590|NCT01264770|144204906|SUPERIORITY_OR_OTHER||Weighted difference in proportions|-0.17||||0.002|TWO_SIDED|90.0|-0.27|-0.08||Week 24|Mantel Haenszel|p-values are calculated using a Mantel-Haenszel approach stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.|90% confidence intervals are calculated using a Mantel-Haenszel approach stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.|Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||-0.08|-0.27|0.002
72340591|NCT01264770|144204907|SUPERIORITY_OR_OTHER||Treatment difference|23.39|||<|0.001|TWO_SIDED|90.0|9.57|40.0|||Van Elteren|Estimated using the Van Elteren test stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.||Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||40.00|9.57|<0.001
72340592|NCT01264770|144204907|SUPERIORITY_OR_OTHER||Treatment difference|22.97||||0.006|TWO_SIDED|90.0|7.84|38.34|||Van Elteren|Estimated using the Van Elteren test stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.||Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||38.34|7.84|0.006
72340593|NCT01264770|144204907|SUPERIORITY_OR_OTHER||Treatment difference|5.72||||0.234|TWO_SIDED|90.0|-3.2|21.68|||Van Elteren|Estimated using the Van Elteren test stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.||Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||21.68|-3.20|0.234
72340594|NCT01264770|144204908|SUPERIORITY_OR_OTHER||Treatment difference|-13.72||||0.03|TWO_SIDED|90.0|-25.01|0.0|||Van Elteren|Estimated using the Van Elteren test stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.||Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||0.00|-25.01|0.030
72340595|NCT01264770|144204908|SUPERIORITY_OR_OTHER||Treatment difference|-9.49||||0.207|TWO_SIDED|90.0|-25.0|6.96|||Van Elteren|Estimated using the Van Elteren test stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.||Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||6.96|-25.00|0.207
72340596|NCT01264770|144204908|SUPERIORITY_OR_OTHER||Treatment difference|-19.53||||0.002|TWO_SIDED|90.0|-30.01|-6.25|||Van Elteren|Estimated using the Van Elteren test stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.||Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||-6.25|-30.01|0.002
72340597|NCT01264770|144204909|SUPERIORITY_OR_OTHER||Treatment difference|0.24||||0.007|TWO_SIDED|90.0|0.09|0.38|||ANCOVA|Including terms for baseline as a continuous covariate \& treatment, DMARD naivety (DMARD naive vs DMARD-IR/intolerant) \& pooled country as factors.||Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||0.38|0.09|0.007
72340598|NCT01264770|144204909|SUPERIORITY_OR_OTHER||Treatment difference|0.22||||0.016|TWO_SIDED|90.0|0.07|0.37|||ANCOVA|Including terms for baseline as a continuous covariate \& treatment, DMARD naivety (DMARD naive vs DMARD-IR/intolerant) \& pooled country as factors.||Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||0.37|0.07|0.016
72340599|NCT01264770|144204909|SUPERIORITY_OR_OTHER||Treatment difference|0.14||||0.094|TWO_SIDED|90.0|0.0|0.29|||ANCOVA|Includes terms for baseline as a continuous covariate \& treatment, DMARD naivety (DMARD naive vs DMARD-IR/intolerant) \& pooled country as factors.||Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||0.29|0.00|0.094
72340600|NCT01264770|144204910|SUPERIORITY_OR_OTHER||Treatment difference|-0.2||||0.043|TWO_SIDED|90.0|-0.36|-0.04|||ANCOVA|Including terms for baseline as a continuous covariate \& treatment, DMARD naivety (DMARD naive vs DMARD-IR/intolerant) \& pooled country as factors.||Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||-0.04|-0.36|0.043
72340601|NCT01264770|144204910|SUPERIORITY_OR_OTHER||Treatment difference|-0.14||||0.158|TWO_SIDED|90.0|-0.31|0.02|||ANCOVA|Including terms for baseline as a continuous covariate \& treatment, DMARD naivety (DMARD naive vs DMARD-IR/intolerant) \& pooled country as factors.||Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||0.02|-0.31|0.158
72340602|NCT01264770|144204910|SUPERIORITY_OR_OTHER||Treatment difference|-0.32||||0.001|TWO_SIDED|90.0|-0.47|-0.16|||ANCOVA|Includes terms for baseline as a continuous covariate \& treatment, DMARD naivety (DMARD naive vs DMARD-IR/intolerant) \& pooled country as factors.||Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||-0.16|-0.47|0.001
72340603|NCT01264770|144204911|SUPERIORITY_OR_OTHER||Treatment difference|-2.77||||0.05|TWO_SIDED|90.0|-5.08|-0.45|||ANCOVA|Including terms for baseline as a continuous covariate \& treatment, DMARD naivety (DMARD naive vs DMARD-IR/intolerant) \& pooled country as factors.||Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||-0.45|-5.08|0.050
72428422|NCT02802020|144367780|SUPERIORITY|||||||0.999|||||||Fisher Exact|||"We hypothesized that pain reduction (as defined in Study endpoints above) would be achieved in a performance goal of at least 53% of patients receiving the study SEMS. Assuming an observed pain reduction rate of 75% and using an exact test with a one-sided alpha of 0.025, 43 patients were required to obtain power of at least 80%."||||0.999
72340604|NCT01264770|144204911|SUPERIORITY_OR_OTHER||Treatment difference|-1.33||||0.36|TWO_SIDED|90.0|-3.73|1.06|||ANCOVA|Including terms for baseline as a continuous covariate \& treatment, DMARD naivety (DMARD naive vs DMARD-IR/intolerant) \& pooled country as factors.||Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||1.06|-3.73|0.360
72340605|NCT01264770|144204911|SUPERIORITY_OR_OTHER||Treatment difference|-2.99||||0.032|TWO_SIDED|90.0|-5.29|-0.7|||ANCOVA|Includes terms for baseline as a continuous covariate \& treatment, DMARD naivety (DMARD naive vs DMARD-IR/intolerant) \& pooled country as factors.||Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||-0.70|-5.29|0.032
72340606|NCT01264770|144204912|SUPERIORITY_OR_OTHER||Treatment difference|-1.02||||0.568|TWO_SIDED|90.0|-3.95|1.92|||ANCOVA|Including terms for baseline as a continuous covariate \& treatment, DMARD naivety (DMARD naive vs DMARD-IR/intolerant) \& pooled country as factors.||Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||1.92|-3.95|0.568
72340607|NCT01264770|144204912|SUPERIORITY_OR_OTHER||Treatment difference|-1.66||||0.368|TWO_SIDED|90.0|-4.69|1.38|||ANCOVA|Including terms for baseline as a continuous covariate \& treatment, DMARD naivety (DMARD naive vs DMARD-IR/intolerant) \& pooled country as factors.||Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||1.38|-4.69|0.368
72340608|NCT01264770|144204912|SUPERIORITY_OR_OTHER||Treatment difference|-2.48||||0.16|TWO_SIDED|90.0|-5.38|0.43|||ANCOVA|Includes terms for baseline as a continuous covariate \& treatment, DMARD naivety (DMARD naive vs DMARD-IR/intolerant) \& pooled country as factors.||Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||0.43|-5.38|0.160
72340609|NCT00424190|144204916|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% confidence interval (CI) for the observed difference in the primary outcome measure between ceftaroline and vancomycin plus aztreonam was calculated. Noninferiority was concluded if the lower limit of the 95% CI was higher than -10%.|Risk Difference (RD)|1.0|||||TWO_SIDED|95.0|-4.2|6.2|||||Risk difference corresponds to Ceftaroline clinical cure rate minus Vancomycin plus Aztreonam clinical cure rate. The confidence interval was calculated using the Miettinen and Nurminen method without adjustment.|The primary objective of this study was to determine the noninferiority in clinical cure rate of ceftaroline in comparison with vancomycin plus aztreonam in adult subjects with cSSSI.||6.2|-4.2|
72340610|NCT01672866|144204924|SUPERIORITY||Difference in LSMeans [SIM - Placebo]|-0.2|||||TWO_SIDED|95.0|-1.3|1.0||||||A mixed-effect model for repeated measures (MMRM) with an unstructured variance-covariance matrix for each participant was used to calculate a point estimate and a 95% confidence interval (CI) for the treatment difference between each treatment arm and placebo in least squares mean (LSMean) change from baseline in MQC at Week 96. With MMRM setting, all participants with available data from 3 treatment groups with change in MQC at Week 48 and/or Week 96 contributed to the overall model.||1.0|-1.3|
72340611|NCT01672866|144204924|SUPERIORITY||Difference in LSMeans [SIM - Placebo]|-0.4|||||TWO_SIDED|95.0|-1.5|0.8||||||An MMRM with an unstructured variance-covariance matrix for each participant was used to calculate a point estimate and a 95% CI for the treatment difference between each treatment arm and placebo in LSMean change from baseline in MQC at Week 96. With MMRM setting, all participants with available data from 3 treatment groups with change in MQC at Week 48 and/or Week 96 contributed to the overall model.||0.8|-1.5|
72340612|NCT01672866|144204925|SUPERIORITY|||||||0.73|||||||Stratified log-rank test|||Differences in EFS between a given SIM group and placebo were assessed using the log-rank test stratified by the presence or absence of diabetes at baseline.||||0.73
72340613|NCT01672866|144204925|SUPERIORITY|||||||0.85|||||||Stratified log-rank test|||Differences in EFS between a given SIM group and placebo were assessed using the log-rank test stratified by the presence or absence of diabetes at baseline.||||0.85
72340614|NCT05714943|144204943|SUPERIORITY|||||||0.99|||||||Regression, Linear|||||||.99
72340615|NCT05714943|144204944|SUPERIORITY|||||||0|||||||Regression, Linear|||||||.00
72340616|NCT05714943|144204945|SUPERIORITY|||||||0.09|||||||Regression, Linear|||||||.09
72340617|NCT05714943|144204946|SUPERIORITY|||||||0.57|||||||Regression, Linear|||||||.57
72340618|NCT05714943|144204947|SUPERIORITY|||||||0.32|||||||Regression, Linear|||||||.32
72340619|NCT05714943|144204948|SUPERIORITY|||||||0|||||||Regression, Linear|||||||.00
72340620|NCT05714943|144204949|SUPERIORITY|||||||0.97|||||||Regression, Linear|||||||.97
72340621|NCT05714943|144204950|SUPERIORITY|||||||0.21|||||||Regression, Linear|||||||.21
72340622|NCT05714943|144204951|SUPERIORITY|||||||0.27|||||||Regression, Linear|||||||.27
72340623|NCT05714943|144204952|SUPERIORITY|||||||0|||||||Regression, Linear|||||||.00
72340624|NCT05714943|144204953|SUPERIORITY|||||||0.86|||||||Regression, Linear|||||||.86
72340625|NCT05714943|144204954|SUPERIORITY|||||||0.61|||||||Regression, Linear|||||||.61
72340626|NCT05714943|144204955|SUPERIORITY|||||||0.02|||||||Regression, Linear|||||||.02
72340627|NCT05714943|144204956|SUPERIORITY|||||||0.08|||||||Regression, Linear|||||||.08
72340628|NCT05714943|144204957|SUPERIORITY|||||||0.08|||||||Regression, Linear|||||||.08
72340629|NCT05714943|144204958|SUPERIORITY|||||||0.06|||||||Regression, Linear|||||||.06
72340630|NCT05714943|144204959|SUPERIORITY|||||||0|||||||Regression, Linear|||||||.00
72340631|NCT05714943|144204960|SUPERIORITY|||||||0.88|||||||Regression, Linear|||||||.88
72340632|NCT05714943|144204961|SUPERIORITY|||||||0.94|||||||Regression, Linear|||||||.94
72340633|NCT05501795|144205039|OTHER||Mean Difference (Final Values)|-2.1|STANDARD_DEVIATION|5.8|<|0.001|TWO_SIDED||||||t-test, 2 sided|||||||< 0.001
72340634|NCT02046070|144205069|OTHER|||||||0.4859|||||||Chi-squared|||P-value tests the null hypothesis: CR+VGPR rate=27% in treatment arms obtained using the one-sided Chi-Square test with alpha=0.10.||||0.4859
72340635|NCT02046070|144205069|OTHER|||||||0.6757|||||||Chi-squared|||P-value tests the null hypothesis: CR+VGPR rate=27% in treatment arms obtained using the one-sided Chi-Square test with alpha=0.10.||||0.6757
72340636|NCT02046070|144205070|OTHER|||||||0.9688|||||||Chi-squared|||P-value tests the null hypothesis: CR+VGPR+PR rate=60% obtained using the one-sided Chi-Square test with alpha=0.10.||||0.9688
72340637|NCT05601102|144205136|EQUIVALENCE|pre- to post-intervention paired t-test, two-tailed||||||0.41|||||||t-test, 2 sided|||||||.41
72340638|NCT05601102|144205137|EQUIVALENCE|pre- to post-intervention paired t-test, two-tailed||||||0.01|||||||t-test, 2 sided|||Anxiety subscale analysis||||.01
72340639|NCT05601102|144205137|EQUIVALENCE|pre- to post-intervention paired t-test, two-tailed||||||0.42|||||||t-test, 2 sided|||Depression subscale||||.42
72340640|NCT05601102|144205138|EQUIVALENCE|pre- to post-intervention paired t-test, two-tailed||||||0.04|||||||t-test, 2 sided|||||||.04
72340641|NCT05601102|144205139|EQUIVALENCE|pre- to post-intervention paired t-test, two-tailed||||||0.15|||||||t-test, 2 sided|||||||.15
72340642|NCT05601102|144205140|EQUIVALENCE|pre- to post-intervention paired t-test, two-tailed||||||0.02|||||||t-test, 2 sided|||||||.02
72340643|NCT05601102|144205141|EQUIVALENCE|pre- to post-intervention paired t-test, two-tailed||||||0.22|||||||t-test, 2 sided|||||||.22
72340644|NCT05601102|144205142|EQUIVALENCE|pre- to post-intervention paired t-test, two-tailed||||||0.29|||||||t-test, 2 sided|||||||.29
72340645|NCT05601102|144205143|EQUIVALENCE|pre- to post-intervention paired t-test, two-tailed||||||1|||||||t-test, 2 sided|||||||1.00
72340646|NCT05601102|144205144|EQUIVALENCE|pre- to post-intervention paired t-test, two-tailed||||||0.6|||||||t-test, 2 sided|||||||.60
72340647|NCT05601102|144205145|EQUIVALENCE|pre- to post-intervention paired t-test, two-tailed||||||1|||||||t-test, 2 sided|||||||1.00
72340648|NCT05601102|144205146|EQUIVALENCE|pre- to post-intervention paired t-test, two-tailed|||||<|0.001|||||||t-test, 2 sided|||||||<.001
72340649|NCT04908280|144205158|SUPERIORITY|||||||0.0308|||||||ANOVA|||||||0.0308
72428423|NCT02802020|144367781|SUPERIORITY|we hypothesized that the proportion of patients reporting one or more related SAE(s) would be below a performance goal of 32%. Assuming an observed SAE rate of 15% and using an exact test with one-sided alpha of 0.025, 57 patients were required to obtain power of at least 80%.||||||0.513|||||||Fisher Exact|||||||0.513
72428424|NCT00506285|144367787|NON_INFERIORITY_OR_EQUIVALENCE|F(1,47)=26.7, p=.001||||||0.001|TWO_SIDED|95.0|||||Mixed Models Analysis|F(1,47)=26.7, p=.001||||||.001
72340650|NCT05432167|144205200|SUPERIORITY||Mean Difference (Final Values)|-8.08|STANDARD_ERROR_OF_MEAN|2.676||0.003|TWO_SIDED|95.0|-13.36|-2.79|||Mixed Models Analysis|||The analysis was performed using a mixed-effect model for repeated measures including fixed effects for treatment, visit, stratification variables (SGLT2 inhibitor use and CKD category), and the treatment-by-visit interaction, along with a covariate of the baseline seated SBP value and the baseline seated SBP by visit interaction.||-2.79|-13.36|0.003
72340651|NCT05432167|144205201|SUPERIORITY||Mean Difference (Final Values)|-7.22|STANDARD_ERROR_OF_MEAN|3.051||0.019|TWO_SIDED|95.0|-13.24|-1.19|||Mixed Models Analysis|||The analysis was performed using a mixed-effect model for repeated measures including fixed effects for treatment, visit, stratification variables (SGLT2 inhibitor use and CKD category), and the treatment-by-visit interaction, along with a covariate of the baseline seated SBP value and the baseline seated SBP by visit interaction.||-1.19|-13.24|0.019
72340652|NCT05432167|144205202|SUPERIORITY||Mean Difference (Final Values)|-8.99|STANDARD_ERROR_OF_MEAN|3.098||0.004|TWO_SIDED|95.0|-15.1|-2.87|||Mixed Models Analysis|||The analysis was performed using a mixed-effect model for repeated measures including fixed effects for treatment, visit, stratification variables (SGLT2 inhibitor use and CKD category), and the treatment-by-visit interaction, along with a covariate of the baseline seated SBP value and the baseline seated SBP by visit interaction.||-2.87|-15.10|0.004
72340653|NCT00140842|144205219|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|15.0|STANDARD_DEVIATION|16.0|<|0.05||95.0|||||t-test, 2 sided|||The null hypothesis was that there is no difference between the groups for peak growth hormone on the growth hormone stimulation test.||||<0.05
72340654|NCT00140842|144205220|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|23.7|STANDARD_DEVIATION|12.0|<|0.05||95.0|||||t-test, 2 sided|||The null hypothesis is that there is no difference between the groups for visceral adipose tissue||||<0.05
72340655|NCT02690649|144205233|SUPERIORITY||estimated adherence rate for the interve|94.0||||0.28|TWO_SIDED|95.0|92.0|95.0|||Regression, Linear|||estimated adherence rate for the intervention group Generalized linear models were used to test the effect of the intervention on medication adherence. These generalized linear models used a Poisson distribution to estimate the rate of adherence with the log of total prescribed doses as an offset term in the linear predictor.||95|92|0.28
72340656|NCT02690649|144205234|SUPERIORITY||||||<|0.001||||||A negative binomial distribution because the outcome was a count variable and it was over-dispersed.|Regression, Linear|Age, previous patient portal logins, and gender were used as co-variates in the model.||||||<0.001
72340657|NCT02690649|144205235|SUPERIORITY||Slope|-0.61||||0.03|TWO_SIDED|95.0|-1.14|-0.07||baseline AF knowledge, gender, age, and educational level were all used as co-variates.|Regression, Linear|generalized linear model tested whether AF knowledge at study completion was related to baseline AF knowledge, gender, age, and educational level||||-0.07|-1.14|0.03
72340658|NCT00907296|144205237|SUPERIORITY||Hazard Ratio (HR)|0.82||||0.3598|TWO_SIDED|95.0|0.53|1.26|||Cox proportional hazard model||A hazard ratio \> 1 favors romosozumab.|The cause-specific hazard was modeled using a Cox proportional hazards model with 10 treatment groups as the independent variable, stratified by type of fracture and definitive fracture fixation (closed with reamed IM nail, Gustilo type I/II open with reamed IM nail, Gustilo type I/II open with unreamed IM nail) and adjusting for quality of surgical fixation.||1.26|0.53|0.3598
72340659|NCT00907296|144205237|SUPERIORITY||Hazard Ratio (HR)|0.91||||0.6544|TWO_SIDED|95.0|0.59|1.39|||Cox proportional hazard model||A hazard ratio \> 1 favors romosozumab.|The cause-specific hazard was modeled using a Cox proportional hazards model with 10 treatment groups as the independent variable, stratified by type of fracture and definitive fracture fixation (closed with reamed IM nail, Gustilo type I/II open with reamed IM nail, Gustilo type I/II open with unreamed IM nail) and adjusting for quality of surgical fixation.||1.39|0.59|0.6544
72340660|NCT00907296|144205237|SUPERIORITY||Hazard Ratio (HR)|1.0||||0.9958|TWO_SIDED|95.0|0.64|1.58|||Cox proportional hazard model||A hazard ratio \> 1 favors romosozumab.|The cause-specific hazard was modeled using a Cox proportional hazards model with 10 treatment groups as the independent variable, stratified by type of fracture and definitive fracture fixation (closed with reamed IM nail, Gustilo type I/II open with reamed IM nail, Gustilo type I/II open with unreamed IM nail) and adjusting for quality of surgical fixation.||1.58|0.64|0.9958
72428425|NCT00506285|144367788|NON_INFERIORITY_OR_EQUIVALENCE|mixed models analysis||||||0.001|TWO_SIDED|95.0||||F(1,47)=24.8, p=.001|Mixed Models Analysis|||||||.001
72340661|NCT00907296|144205237|SUPERIORITY||Hazard Ratio (HR)|0.9||||0.6276|TWO_SIDED|95.0|0.59|1.37|||Cox proportional hazard model||A hazard ratio \> 1 favors romosozumab.|The cause-specific hazard was modeled using a Cox proportional hazards model with 10 treatment groups as the independent variable, stratified by type of fracture and definitive fracture fixation (closed with reamed IM nail, Gustilo type I/II open with reamed IM nail, Gustilo type I/II open with unreamed IM nail) and adjusting for quality of surgical fixation.||1.37|0.59|0.6276
72340662|NCT00907296|144205237|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.8819|TWO_SIDED|95.0|0.63|1.49|||Cox proportional hazard model||A hazard ratio \> 1 favors romosozumab.|The cause-specific hazard was modeled using a Cox proportional hazards model with 10 treatment groups as the independent variable, stratified by type of fracture and definitive fracture fixation (closed with reamed IM nail, Gustilo type I/II open with reamed IM nail, Gustilo type I/II open with unreamed IM nail) and adjusting for quality of surgical fixation.||1.49|0.63|0.8819
72340663|NCT00907296|144205237|SUPERIORITY||Hazard Ratio (HR)|0.92||||0.7197|TWO_SIDED|95.0|0.6|1.42|||Cox proportional hazard model||A hazard ratio \> 1 favors romosozumab.|The cause-specific hazard was modeled using a Cox proportional hazards model with 10 treatment groups as the independent variable, stratified by type of fracture and definitive fracture fixation (closed with reamed IM nail, Gustilo type I/II open with reamed IM nail, Gustilo type I/II open with unreamed IM nail) and adjusting for quality of surgical fixation.||1.42|0.60|0.7197
72340664|NCT00907296|144205237|SUPERIORITY||Hazard Ratio (HR)|1.11||||0.6204|TWO_SIDED|95.0|0.73|1.7|||Cox proportional hazard model||A hazard ratio \> 1 favors romosozumab.|The cause-specific hazard was modeled using a Cox proportional hazards model with 10 treatment groups as the independent variable, stratified by type of fracture and definitive fracture fixation (closed with reamed IM nail, Gustilo type I/II open with reamed IM nail, Gustilo type I/II open with unreamed IM nail) and adjusting for quality of surgical fixation.||1.70|0.73|0.6204
72340665|NCT00907296|144205237|SUPERIORITY||Hazard Ratio (HR)|1.18||||0.4779|TWO_SIDED|95.0|0.75|1.84|||Cox proportional hazard model||A hazard ratio \> 1 favors romosozumab.|The cause-specific hazard was modeled using a Cox proportional hazards model with 10 treatment groups as the independent variable, stratified by type of fracture and definitive fracture fixation (closed with reamed IM nail, Gustilo type I/II open with reamed IM nail, Gustilo type I/II open with unreamed IM nail) and adjusting for quality of surgical fixation.||1.84|0.75|0.4779
72340666|NCT00907296|144205237|SUPERIORITY||Hazard Ratio (HR)|1.0||||0.9952|TWO_SIDED|95.0|0.65|1.53|||Cox proportional hazard model||A hazard ratio \> 1 favors romosozumab.|The cause-specific hazard was modeled using a Cox proportional hazards model with 10 treatment groups as the independent variable, stratified by type of fracture and definitive fracture fixation (closed with reamed IM nail, Gustilo type I/II open with reamed IM nail, Gustilo type I/II open with unreamed IM nail) and adjusting for quality of surgical fixation.||1.53|0.65|0.9952
72340667|NCT00907296|144205240|SUPERIORITY||Hazard Ratio (HR)|0.73||||0.1713|TWO_SIDED|95.0|0.47|1.14|||Cox proportional hazard model||A hazard ratio \> 1 favors romosozumab.|The cause-specific hazard was modeled using a Cox proportional hazards model with 10 treatment groups as the independent variable, stratified by type of fracture and definitive fracture fixation (closed with reamed IM nail, Gustilo type I/II open with reamed IM nail, Gustilo type I/II open with unreamed IM nail) and adjusting for quality of surgical fixation.||1.14|0.47|0.1713
72340668|NCT00907296|144205240|SUPERIORITY||Hazard Ratio (HR)|1.0||||0.9958|TWO_SIDED|95.0|0.65|1.53|||Cox proportional hazard model||A hazard ratio \> 1 favors romosozumab.|The cause-specific hazard was modeled using a Cox proportional hazards model with 10 treatment groups as the independent variable, stratified by type of fracture and definitive fracture fixation (closed with reamed IM nail, Gustilo type I/II open with reamed IM nail, Gustilo type I/II open with unreamed IM nail) and adjusting for quality of surgical fixation.||1.53|0.65|0.9958
72340669|NCT00907296|144205240|SUPERIORITY||Hazard Ratio (HR)|1.27||||0.295|TWO_SIDED|95.0|0.81|1.97|||Cox proportional hazard model||A hazard ratio \> 1 favors romosozumab.|The cause-specific hazard was modeled using a Cox proportional hazards model with 10 treatment groups as the independent variable, stratified by type of fracture and definitive fracture fixation (closed with reamed IM nail, Gustilo type I/II open with reamed IM nail, Gustilo type I/II open with unreamed IM nail) and adjusting for quality of surgical fixation.||1.97|0.81|0.2950
72340670|NCT00907296|144205240|SUPERIORITY||Hazard Ratio (HR)|0.68||||0.0844|TWO_SIDED|95.0|0.44|1.05|||Cox proportional hazard model||A hazard ratio \> 1 favors romosozumab.|The cause-specific hazard was modeled using a Cox proportional hazards model with 10 treatment groups as the independent variable, stratified by type of fracture and definitive fracture fixation (closed with reamed IM nail, Gustilo type I/II open with reamed IM nail, Gustilo type I/II open with unreamed IM nail) and adjusting for quality of surgical fixation.||1.05|0.44|0.0844
72340671|NCT00907296|144205240|SUPERIORITY||Hazard Ratio (HR)|0.8||||0.3225|TWO_SIDED|95.0|0.52|1.24|||Cox proportional hazard model||A hazard ratio \> 1 favors romosozumab.|The cause-specific hazard was modeled using a Cox proportional hazards model with 10 treatment groups as the independent variable, stratified by type of fracture and definitive fracture fixation (closed with reamed IM nail, Gustilo type I/II open with reamed IM nail, Gustilo type I/II open with unreamed IM nail) and adjusting for quality of surgical fixation.||1.24|0.52|0.3225
72340672|NCT00907296|144205240|SUPERIORITY||Hazard Ratio (HR)|1.17||||0.4754|TWO_SIDED|95.0|0.76|1.81|||Cox proportional hazard model||A hazard ratio \> 1 favors romosozumab.|The cause-specific hazard was modeled using a Cox proportional hazards model with 10 treatment groups as the independent variable, stratified by type of fracture and definitive fracture fixation (closed with reamed IM nail, Gustilo type I/II open with reamed IM nail, Gustilo type I/II open with unreamed IM nail) and adjusting for quality of surgical fixation.||1.81|0.76|0.4754
72340673|NCT00907296|144205240|SUPERIORITY||Hazard Ratio (HR)|1.14||||0.5578|TWO_SIDED|95.0|0.74|1.75|||Cox proportional hazard model||A hazard ratio \> 1 favors romosozumab.|The cause-specific hazard was modeled using a Cox proportional hazards model with 10 treatment groups as the independent variable, stratified by type of fracture and definitive fracture fixation (closed with reamed IM nail, Gustilo type I/II open with reamed IM nail, Gustilo type I/II open with unreamed IM nail) and adjusting for quality of surgical fixation.||1.75|0.74|0.5578
72428426|NCT01089556|144367789|SUPERIORITY_OR_OTHER||LS Mean Differences (Final Values)|-0.192||||0.37||95.0|||||Mixed Models Analysis|||||||0.370
72428427|NCT01089556|144367790|SUPERIORITY_OR_OTHER||LS Mean Differences (Final Values)|-0.614|||<|0.001||95.0|||||Mixed Models Analysis|||||||<0.001
72340674|NCT00907296|144205240|SUPERIORITY||Hazard Ratio (HR)|1.34||||0.1864|TWO_SIDED|95.0|0.87|2.07|||Cox proportional hazard model||A hazard ratio \> 1 favors romosozumab|The cause-specific hazard was modeled using a Cox proportional hazards model with 10 treatment groups as the independent variable, stratified by type of fracture and definitive fracture fixation (closed with reamed IM nail, Gustilo type I/II open with reamed IM nail, Gustilo type I/II open with unreamed IM nail) and adjusting for quality of surgical fixation.||2.07|0.87|0.1864
72340675|NCT00907296|144205240|SUPERIORITY||Hazard Ratio (HR)|1.04||||0.8488|TWO_SIDED|95.0|0.68|1.59|||Cox proportional hazard model||A hazard ratio \> 1 favors romosozumab.|The cause-specific hazard was modeled using a Cox proportional hazards model with 10 treatment groups as the independent variable, stratified by type of fracture and definitive fracture fixation (closed with reamed IM nail, Gustilo type I/II open with reamed IM nail, Gustilo type I/II open with unreamed IM nail) and adjusting for quality of surgical fixation.||1.59|0.68|0.8488
72340676|NCT03344640|144205251|SUPERIORITY||Mean Difference (Final Values)|-0.77||||0.875|TWO_SIDED|90.0|-8.84|7.3|||LS mean|LS mean change from baseline in WORC total percentage score||All Patients at day 99||7.30|-8.84|0.875
72340677|NCT03344640|144205252|SUPERIORITY||Difference and 90% CI versus placebo|3.97||||0.19|TWO_SIDED|90.0|-1.03|8.97|||LS mean|LS mean change from baseline in WORC total percentage score||All patientts at day 15||8.97|-1.03|0.190
72340678|NCT03344640|144205252|SUPERIORITY||Difference and 90% CI versus placebo|3.97|||||TWO_SIDED|90.0|-3.39|9.11|||LS Mean|LS mean change from baseline in WORC total percentage score||All patients at day 29||9.11|-3.39|
72340679|NCT03344640|144205252|SUPERIORITY||Difference and 90% CI versus placebo|0.761||||0.761|TWO_SIDED|90.0|-8.81|6.08|||LS Mean|LS mean change from baseline in WORC total percentage score||All patients at day 57||6.08|-8.81|0.761
72340680|NCT03344640|144205252|SUPERIORITY||Difference and 90% CI versus placebo|0.765||||0.765|TWO_SIDED|90.0|-6.27|9.03|||LS Mean|LS mean change from baseline in WORC total percentage score||All patients at day 85||9.03|-6.27|0.765
72340681|NCT03344640|144205252|SUPERIORITY||Difference and 90% CI versus placebo|0.491||||0.491|TWO_SIDED|90.0|-4.73|11.45|||LS Mean|LS mean change from baseline in WORC total percentage score||All patients at day 127||11.45|-4.73|0.491
72340682|NCT03344640|144205252|SUPERIORITY||Difference and 90% CI versus placebo|2.44||||0.639|TWO_SIDED|90.0|-6.19|11.07|||LS Mean|LS mean change from baseline in WORC total percentage score||All patients at end of study||11.07|-6.19|0.639
72340683|NCT03344640|144205253|SUPERIORITY||Difference and 90% CI versus Placebo|1.23||||0.735|TWO_SIDED|90.0|-4.81|7.28||Difference and 90% CI versus placebo|LS Mean|LS mean change from baseline in QuickDASH total score||Statistical analysis results of QuickDASH total score (PD Analysis Set) at day 99||7.28|-4.81|0.735
72340684|NCT03344640|144205253|SUPERIORITY||Difference and 90% CI versus Placebo|1.51||||0.689|TWO_SIDED|90.0|-4.76|7.79|||LS Mean|LS mean change from baseline in QuickDASH total score||Statistical analysis results of QuickDASH total score (PD analysis set) at End of Study||7.79|-4.76|0.689
72340685|NCT03344640|144205254|SUPERIORITY||Difference and 90% CI vesus placebo|3.5||||0.411|TWO_SIDED|90.0|-3.54|10.54|||LS Mean|LS mean change from baseline in ASES total percentage score||Statistical analysis results of ASES total score (PD analysis) at day 99||10.54|-3.54|0.411
72340686|NCT03344640|144205254|SUPERIORITY||Difference and 90% CI versus placebo|1.14||||0.804|TWO_SIDED|90.0|-6.5|8.78|||LS Mean|LS mean change from baseline in ASES total percentage score||Statistical analysis results of ASES total score (PD analysis) at End of Study set)||8.78|-6.50|0.804
72340687|NCT03344640|144205255|SUPERIORITY||Difference and 90% CI versus placebo|-1.26||||0.706|TWO_SIDED|90.0|-6.81|4.29|||LS Mean|LS Mean change from baseline in Your Health Today Score at day 99||Statistical analysis results of Your Health Today EQ-5D-5L Index score at day 99 (PD Analysis Set)||4.29|-6.81|0.706
72340688|NCT03344640|144205255|SUPERIORITY||Difference and 90% CI versus placebo|-1.9||||0.647|TWO_SIDED|90.0|-8.79|4.99|||LS Mean|LS mean change from baseline in Your Health Today score||Statistical analysis results of Your Health Today EQ-5D-5L Index score at End of Study||4.99|-8.79|0.647
72340689|NCT03344640|144205256|SUPERIORITY||Difference and 90% CI versus placebo|0.01||||0.613|TWO_SIDED|90.0|-0.03|0.06|||LS Mean|LS mean change from baseline in EQ-5D-5L Index score||Statistical analysis results of of EQ-5D-5L Index score at day 99 (PD Analysis Set)||0.06|-0.03|0.613
72340690|NCT03344640|144205256|SUPERIORITY||Difference and 90% CI versus placebo|0.02||||0.74|TWO_SIDED|90.0|-0.04|0.06|||LS Mean|LS mean change from baseline in EQ-5D-5L Index score||Statistical analysis results of of EQ-5D-5L Index score at End of Study (PD Analysis Set)||0.06|-0.04|0.740
72340691|NCT03344640|144205257|SUPERIORITY||Difference and 90% CI versus placebo|-5.55||||0.281|TWO_SIDED|90.0|-14.07|2.97|||LS Mean|LS MMean CFB (90% CI)||Statistical analysis results of pain score using VAS scale (PD Analysis Set) at day 99||2.97|-14.07|0.281
72340692|NCT03344640|144205257|SUPERIORITY||Difference and 90% CI versus placebo|-1.49||||0.78|TWO_SIDED|90.0|-10.33|7.35|||LS Mean|LS Mean CFB (90% CI)||Statistical analysis results of pain score using VAS scale (PD Analysis Set) at End of Study||7.35|-10.33|0.780
72340693|NCT03344640|144205258|SUPERIORITY||Difference and 90% CI versus placebo|-3.32||||0.489|TWO_SIDED|90.0|-11.28|4.64|||LS Mean|LS Mean change from baseline in VAS score||Statistical analysis results of pain score using VAS scale (PD Analysis Set) at day 99||4.64|-11.28|0.489
72340694|NCT03344640|144205258|SUPERIORITY||Difference and 90% CI versus placebo|-8.29||||0.087|TWO_SIDED|90.0|-16.26|-0.32|||LS Mean|LS Mean change from baseline in VAS score||Statistical analysis results of pain score using VAS scale at End of Study||-0.32|-16.26|0.087
72340695|NCT03344640|144205259|SUPERIORITY||Difference and 99% CL versus placebo|6.1||||0.21|TWO_SIDED|90.0|-1.9|13.91|||LS Mean|LS Mean CFB (90% CI)||Statistical analysis results of PhGA score using VAS scale at day 99||13.91|-1.90|0.210
72340696|NCT03344640|144205259|SUPERIORITY||Difference and 90% CI versus placebo|-0.37||||0.942|TWO_SIDED|90.0|-8.86|8.11|||LS Mean|LS Mean CFB (90% CI)||Statistical analysis results of PhGA score using VAS scale at End of Study||8.11|-8.86|0.942
72370038|NCT02105961|144250541|SUPERIORITY||Rate ratio (Mepolizumab 100/Placebo)|0.8||||0.068|TWO_SIDED|95.0|0.65|0.98||Adjusted p-value; Family wise type I error controlled within each endpoint using a Hochberg testing procedure|Negative binomial model||Analysis using a negative binomial model with covariates of treatment, geographic region, no. of moderate/severe exacerbations in previous year, Baseline percent predicted FEV1, smoking status and offset of log (time in on- and off- treatment period)|||0.98|0.65|0.068
72428428|NCT01089556|144367791|SUPERIORITY_OR_OTHER||LS Mean Differences (Final Values)|-0.003||||0.991||95.0|||||Mixed Models Analysis|||||||0.991
72340697|NCT02573246|144205263|SUPERIORITY|Aimed to recruit 20 participants in each condition to align with other neurostimulation studies where 6-20 adults per condition were sufficient to demonstrate proof-of-concept for novel treatments (Bentwich et al., 2011; Cunningham et al., 2015).|Mean Difference (Net)|-0.323|STANDARD_ERROR_OF_MEAN|0.131||0.019|TWO_SIDED|95.0|-0.59|-0.056||A priori threshold for significance was .05.|Mixed Models Analysis||The results presented are between the active right and sham conditions.|A mixed models analysis of variance (MMANOVA) examining regulation duration during each regulation period was conducted using treatment condition (active right, active left, sham), experimental condition (regulation1, regulation2, regulation3), and baseline as predictors.||-.056|-.590|0.019
72340698|NCT02573246|144205263|SUPERIORITY||Mean Difference (Net)|0.237|STANDARD_ERROR_OF_MEAN|0.133||0.08|TWO_SIDED|95.0|-0.034|0.508|||Mixed Models Analysis|||A mixed models analysis of variance (MMANOVA) examining regulation duration during each regulation period was conducted using treatment condition (active right, active left, sham), experimental condition (regulation1, regulation2, regulation3), and baseline as predictors.||.508|-.034|.08
72340699|NCT02573246|144205263|SUPERIORITY||Mean Difference (Net)|-0.227|STANDARD_ERROR_OF_MEAN|0.103||0.033|TWO_SIDED|95.0|-0.434|-0.02||A priori threshold for significance was set to .05.|Mixed Models Analysis|we controlled for baseline and for the distance between the brain and the scalp||Regulation duration was transformed using a logarithmic transformation to achieve normality||-.020|-.434|.033
72340700|NCT02573246|144205264|SUPERIORITY||Mean Difference (Net)|-0.124|STANDARD_ERROR_OF_MEAN|0.184||0.51|TWO_SIDED|95.0|-0.504|0.256||A priori set threshold for statistical significance was 0.05|ANOVA|||A univariate general linear model was employed to test of regulation duration, transformed for normality.||.256|-0.504|.51
72340701|NCT02573246|144205264|SUPERIORITY||Mean Difference (Net)|0.007|STANDARD_ERROR_OF_MEAN|0.18||0.97|TWO_SIDED|95.0|-0.364|0.378|||ANOVA|||||.378|-.364|.97
72340702|NCT02573246|144205264|SUPERIORITY||Mean Difference (Net)|0.147993|STANDARD_ERROR_OF_MEAN|0.167031||0.39|TWO_SIDED|95.0|-0.215936|0.511921||A priori set significance threshold was 0.05|t-test, 2 sided|||A t test of the variable 'time it took to return to HR baseline', transformed for normality was used to examine between condition differences at the 1 month follow up.||0.511921|-0.215936|0.39
72340703|NCT02573246|144205265|SUPERIORITY|HF-HRV was transformed using the function lg10\*(HF-HRV\*1000000) in order to be normally distributed.|Mean Difference (Net)|0.16|STANDARD_DEVIATION|0.51||0.022|TWO_SIDED|95.0|0.044|0.267||The threshold for statistical significance was p = 0.05|Mixed Models Analysis|||In the original study (CR+active left rTMS vs CR+ active right rTMS vs CR+sham rTMS), mixed-effects hierarchical linear models (MMANOVA) with analytically determined covariance structures were used to analyze the repeated measures data. We hypothesized that active neurostimulation would increase HF-HRV during regulation.||.267|.044|.022
72340704|NCT02573246|144205265|SUPERIORITY||Mean Difference (Net)|0.11|STANDARD_ERROR_OF_MEAN|0.052||0.0499|TWO_SIDED|95.0|0.000037|0.213074|||Mixed Models Analysis|||MMANOVA||0.213074|0.000037|0.0499
72340705|NCT02573246|144205265|SUPERIORITY|Aimed to recruit 20 participants in each condition to align with other neurostimulation studies where 6-20 adults per condition were sufficient to demonstrate proof-of-concept for novel treatments (Bentwich et al., 2011; Cunningham et al., 2015).|Mean Difference (Net)|0.172|STANDARD_DEVIATION|0.38|<|1e-06|TWO_SIDED|95.0|0.129|0.215||Significance threshold was set at p = 0.05.|Mixed Models Analysis||The MMANOVA analysis used an unstructured covariance structure.|In the supplemental study (CR+active left rTMS with functional targeting vs CR+sham rTMS), mixed-effects hierarchical linear models (MMANOVA) with analytically determined covariance structures were used to analyze the repeated measures data. We hypothesized that active neurostimulation would increase HF-HRV during regulation when compared with sham.||.215|.129|<.000001
72340706|NCT02573246|144205266|SUPERIORITY||Mean Difference (Net)|0.111|STANDARD_ERROR_OF_MEAN|0.091544||0.236|TWO_SIDED|95.0|-0.078086|0.300661||A priori threshold was set to 0.05.|ANCOVA|Brain to skull difference and intake difference in dlPFC activation between regulation and feeling negative were included as confounds.|Parameter estimate is the value of the difference between active stimulation and sham stimulation.|Difference between treatment conditions in dlPFC activation change between feeling negative emotions and downregulation of negative affect a week after intervention, when controlling for baseline activation difference||0.300661|-0.078086|.236
72340707|NCT02573246|144205266|SUPERIORITY||Mean Difference (Net)|0.359024|STANDARD_ERROR_OF_MEAN|0.144067||0.020347|TWO_SIDED|95.0|0.061|0.657049||Threshold was set at 0.05 a priori|ANCOVA|Brain to skull difference and intake difference in vlpfc activation between regulation and feeling negative were included as confounds.||Expected significantly higher activation following active intervention in the vlPFC when compared to sham when engaging in downregulation versus passive experience of negative emotions induced with autobiographical stressors. ROI data was extracted using FSL featquery. A univariate general linear model excluding one outlier from the active condition was conducted for this outcome measure.||0.657049|0.061000|0.020347
72340708|NCT02573246|144205266|SUPERIORITY||Mean Difference (Net)|0.221683|STANDARD_ERROR_OF_MEAN|0.461481||0.635|TWO_SIDED|95.0|-0.732963|1.17633||A priori threshold was set to .05|ANCOVA|Brain to skull difference and intake difference in vmpfc activation between regulation and feeling negative were included as confounds.||Expected significantly higher activation following active intervention in the vmPFC when compared to sham when engaging in downregulation versus passive experience of negative emotions induced with autobiographical stressors. ROI data was extracted with FSL featquery.||1.176330|-0.732963|0.635
72340709|NCT02573246|144205266|SUPERIORITY||Mean Difference (Net)|0.179412|STANDARD_ERROR_OF_MEAN|0.178029||0.324|TWO_SIDED|95.0|-0.188868|0.547692||a priori set threshold was 0.05|ANCOVA|Brain to skull difference and intake difference in amygdala activation between regulation and feeling negative were included as confounds.||Expected significantly lower activation following active intervention in the amygdala when compared to sham when engaging in downregulation versus passive experience of negative emotions induced with autobiographical stressors. ROI data was extracted with featquery (FSL).||0.547692|-0.188868|.324
72340710|NCT02573246|144205266|SUPERIORITY||Mean Difference (Net)|0.021231|STANDARD_ERROR_OF_MEAN|0.071185||0.76819|TWO_SIDED|95.0|-0.126027|0.168489||A priori set threshold was 0.05|ANCOVA|Brain to skull difference and intake difference in insula activation between regulation and feeling negative were included as confounds.||Expected significantly lower activation following active intervention in the insula when compared to sham when engaging in downregulation versus passive experience of negative emotions induced with autobiographical stressors. FSL featquery tool was used to extract ROI (region of interest) data.||0.168489|-0.126027|0.768190
72340711|NCT02573246|144205267|SUPERIORITY||Mean Difference (Net)|0.37|STANDARD_ERROR_OF_MEAN|0.455||0.69|TWO_SIDED|95.0|-0.553|1.293||a priori threshold for significance was 0.05|ANOVA|||Likert-type questions about acceptability were rated on a scale from 0 (not at all) to 9 (extremely) and then averaged to create a mean for acceptability. This average score was normally distributed and therefore was entered into a univariate general linear model where acceptability was entered as a dependent variable and condition as a fixed factor.||1.293|-0.553|0.69
72340712|NCT02573246|144205267|SUPERIORITY||Mean Difference (Net)|0.27|STANDARD_ERROR_OF_MEAN|0.43||0.53|TWO_SIDED|95.0|-0.592|1.139|||ANOVA|||||1.139|-.592|.53
72340713|NCT02573246|144205267|SUPERIORITY||Mean Difference (Net)|-0.66|STANDARD_ERROR_OF_MEAN|0.45||0.15|TWO_SIDED|95.0|-1.59|0.27||a priory threshold for significance was .05|t-test, 2 sided|||we compared differences in acceptability between conditions using an independent samples t-test (acceptability was normally distributed)||0.27|-1.59|0.15
72340714|NCT02573246|144205268|SUPERIORITY||Mean Difference (Net)|0.295|STANDARD_ERROR_OF_MEAN|0.304||0.551|TWO_SIDED|95.0|-0.322|0.912||a priori threshold was set to 0.05|ANOVA|||We compared differences between conditions in the perceived feasibility of the procedures. Feasibility average was normally distributed and therefore a general linear model, univariate was employed to test between condition effects.||0.912|-0.322|0.551
72340715|NCT02573246|144205268|SUPERIORITY||Mean Difference (Net)|0.002|STANDARD_ERROR_OF_MEAN|0.281||0.995|TWO_SIDED|95.0|-0.567|0.571|||ANOVA|||||.571|-.567|.995
72340716|NCT02573246|144205268|SUPERIORITY||Mean Difference (Net)|-0.09957|STANDARD_ERROR_OF_MEAN|0.371||0.791|TWO_SIDED|95.0|-0.8672|0.6681||A priori threshold for statistical significance was set to 0.05|t-test, 2 sided|df = 23||We examined differences in feasibility between the active and sham condition in the sub-study where fMRI targeting was utilized. Average feasibility was normally distributed and therefore an independent samples t-test was used to test this outcome.||0.6681|-0.8672|0.791
72340717|NCT02573246|144205269|SUPERIORITY||Mean Difference (Net)|6.04|STANDARD_ERROR_OF_MEAN|8.048||0.61|TWO_SIDED|95.0|-9.522964|21.60462||A priori threshold was set to 0.05|Mixed Models Analysis|||To test the long-term effects of the intervention, a MMANOVA model was conducted examining between-condition differences at the 1-week and 1-month follow-up in the OQ-45. Baseline was co-varied.||21.604620|-9.522964|0.61
72340718|NCT02573246|144205269|SUPERIORITY||Mean Difference (Net)|-0.906|STANDARD_ERROR_OF_MEAN|7.37||0.9|TWO_SIDED|95.0|-15.83|14.02||a priori threshold was set to .05|Mixed Models Analysis|||||14.02|-15.83|.90
72340719|NCT02573246|144205269|SUPERIORITY||Mean Difference (Net)|10.46|STANDARD_ERROR_OF_MEAN|7.93||0.2|TWO_SIDED|95.0|-5.971581|26.892619||threshold was set to 0.05 a priori|Mixed Models Analysis||HLM models used a compound symmetry covariance structure.|||26.892619|-5.971581|.20
72340720|NCT02573246|144205270|SUPERIORITY||Mean Difference (Net)|-0.55|STANDARD_ERROR_OF_MEAN|0.258||0.034|TWO_SIDED|95.0|-1.062356|-0.043203||A priori threshold was set to .05 for significance.|Mixed Models Analysis|Subjective Units of Distress (SUDS) right before the intervention were co-varied as baseline.|Results reported are for active left vs. sham comparison.|Hypothesized that active neurostimulation would lead to lower daily distress than sham stimulation. We used a hierarchical linear model (HLM) for this analysis with an identity covariance structure (random intercept and random slope).||-0.043203|-1.062356|.034
72340721|NCT02573246|144205270|SUPERIORITY||Mean Difference (Net)|0.631|STANDARD_ERROR_OF_MEAN|0.404||0.133|TWO_SIDED|95.0|-0.208|1.47||A priori set threshold was .05|Mixed Models Analysis|||Hypothesized that active neurostimulation will lead to less daily distress than sham neurostimulation during the ambulatory data collection. An HLM analysis was conducted using an unstructured covariance structure and reported distress right before the intervention as baseline.||1.47|-.208|.133
72340722|NCT02573246|144205271|SUPERIORITY||Mean Difference (Net)|-1.300772|STANDARD_ERROR_OF_MEAN|2.670936||0.629061|TWO_SIDED|95.0|-6.708548|4.107||A priori threshold was set to .05|Mixed Models Analysis|Intake values for the dependent measures were covaried. The time by condition interaction term was included.||Mixed model analyses of variance (MMANOVAs) were conducted to explore the difference between active and sham neurostimulation on self reported indices of regulation and psychopathology. We expected active neurostimulation to lead to less functional impairment than sham neurostimulation.||4.107|-6.708548|0.629061
72340723|NCT02573246|144205271|SUPERIORITY||Mean Difference (Net)|-0.977394|STANDARD_ERROR_OF_MEAN|2.605189||0.71|TWO_SIDED|95.0|-6.255223|4.300434|||Mixed Models Analysis|||We expected lower functional impairment in the active right versus the sham condition.||4.300434|-6.255223|0.71
72428429|NCT01089556|144367792|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.431|||<|0.001|TWO_SIDED|95.0|1.233|1.662|||Cochran-Mantel-Haenszel|||||1.662|1.233|<0.001
72428430|NCT01089556|144367793|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.052||||0.565|TWO_SIDED|95.0|0.884|1.253|||Cochran-Mantel-Haenszel|||||1.253|0.884|0.565
72340724|NCT02573246|144205271|SUPERIORITY||Mean Difference (Net)|-3.292137|STANDARD_ERROR_OF_MEAN|3.314194||0.331|TWO_SIDED|95.0|-10.157811|3.573537||A priori set threshold was .05|Mixed Models Analysis|Baseline WSAS was covaried|The analysis compared sham versus active stimulation.|Mixed model analyses of variance (MMANOVAs) were conducted to explore the difference between active and sham neurostimulation on self reported indices of regulation and psychopathology in the substudy also. We expected active neurostimulation to lead to less impairment than sham neurostimulation.||3.573537|-10.157811|0.331
72340725|NCT02573246|144205271|SUPERIORITY||Mean Difference (Net)|0.284589|STANDARD_ERROR_OF_MEAN|0.276698||0.31|TWO_SIDED|95.0|-0.27603|0.845209||A priori set threshold for significance was 0.05|Mixed Models Analysis|baseline was covaried||Mixed model analyses of variance (MMANOVAs) were conducted to explore the difference between active and sham neurostimulation on self reported indices of regulation and psychopathology. We expected active neurostimulation to lead to more use of cognitive restructuring than sham neurostimulation.||0.845209|-0.276030|0.31
72340726|NCT02573246|144205271|SUPERIORITY||Mean Difference (Net)|10.129377|STANDARD_ERROR_OF_MEAN|9.150339||0.275257|TWO_SIDED|95.0|-8.394724|28.653479|||Mixed Models Analysis|||We hypothesized that active right neurostimulation would yield lower emotional dysregulation after the intervention when compared to sham neurostimulation.||28.653479|-8.394724|0.275257
72428431|NCT01089556|144367794|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.467|||<|0.001|TWO_SIDED|95.0|1.214|1.771|||Cochran-Mantel-Haenszel|||||1.771|1.214|<0.001
72428432|NCT01089556|144367795|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.233||||0.068|TWO_SIDED|95.0|0.98|1.55|||Cochran-Mantel-Haenszel|||||1.550|0.980|0.068
72428433|NCT01089556|144367796|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.279|||<|0.001|TWO_SIDED|95.0|1.125|1.456|||Cochran-Mantel-Haenszel|||||1.456|1.125|<0.001
72340727|NCT02573246|144205271|SUPERIORITY||Mean Difference (Net)|-13.187|STANDARD_ERROR_OF_MEAN|6.212753||0.044|TWO_SIDED|95.0|-26.002351|-0.372281||A priori set significance threshold was 0.05|Mixed Models Analysis|||Mixed model analyses of variance (MMANOVAs) were conducted to explore the difference between active and sham neurostimulation on self reported indices of regulation and psychopathology. We expected active neurostimulation to lead to less emotional dysregulation than sham neurostimulation.||-0.372281|-26.002351|0.044
72340728|NCT02573246|144205271|SUPERIORITY||Mean Difference (Net)|0.927909|STANDARD_ERROR_OF_MEAN|9.603423||0.924|TWO_SIDED|95.0|-18.508252|20.364071||A priori set threshold for statistical significance was 0.05|Mixed Models Analysis|baseline was covaried||We expected active stimulation to lead to less emotional dysregulation than sham neurostimulation. A MMANOVA model was employed, controlling for baseline.||20.364071|-18.508252|.924
72340729|NCT02573246|144205271|SUPERIORITY||Mean Difference (Net)|-0.017547|STANDARD_ERROR_OF_MEAN|0.267983||0.95|TWO_SIDED|95.0|-0.560994|0.525901|||Mixed Models Analysis|||we expected more use of cr following active right neurostimulation then after following sham neurostimulation.||0.525901|-0.560994|.95
72340730|NCT02573246|144205271|SUPERIORITY||Mean Difference (Net)|-0.096719|STANDARD_ERROR_OF_MEAN|0.389897||0.806|TWO_SIDED|95.0|-0.900919|0.707481||A priori set significance threshold was 0.05|Mixed Models Analysis|Baseline use of cognitive restructuring was covaried||Mixed model analyses of variance (MMANOVAs) were conducted to explore the difference between active and sham neurostimulation on self reported indices of regulation and psychopathology. We expected active neurostimulation to lead to more use of cognitive restructuring than sham neurostimulation.||0.707481|-0.900919|.806
72340731|NCT02968914|144205329|SUPERIORITY||Geometric mean ratio (%)|94.46|||||TWO_SIDED|90.0|88.16|101.21|||ANOVA|||||101.21|88.16|
72340732|NCT02968914|144205330|SUPERIORITY||Geometric mean ratio (%)|92.83|||||TWO_SIDED|90.0|87.41|98.58|||ANOVA|||||98.58|87.41|
72340733|NCT02968914|144205331|SUPERIORITY||Geometric mean ratio (%)|92.34|||||TWO_SIDED|90.0|86.34|98.75|||ANOVA|||||98.75|86.34|
72340734|NCT02636946|144205347|NON_INFERIORITY|MMRM was used for IOP change from baseline. The model includes IOP change from baseline as the response variable and treatment, visit, eye, baseline IOP, treatment-by-baseline, treatment-by-eye, treatment-by-visit, visit-by-eye interactions as covariates. A Kronecker product of unstructured covariance matrix for study visit and compound symmetry covariance matrix for between eye correlation was used in the analysis.|Least-squares Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.29||0.0166|TWO_SIDED|95.0|-1.28|-0.13|||MMRM|||Change from Baseline at Week 4: The null hypothesis was that bimatoprost SR 15 μg was to be declared non-inferior to SLT if the upper limit of the 95% CI was ≤ 1.5 mmHg at all scheduled visits (Weeks 4, 12, and 24).||-0.13|-1.28|0.0166
72340735|NCT02636946|144205348|NON_INFERIORITY|MMRM was used for IOP change from baseline. The model includes IOP change from baseline as the response variable and treatment, visit, eye, baseline IOP, treatment-by-baseline, treatment-by-eye, treatment-by-visit, visit-by-eye interactions as covariates. A Kronecker product of unstructured covariance matrix for study visit and compound symmetry covariance matrix for between eye correlation was used in the analysis.|Least-squares Mean Difference|-0.52|STANDARD_ERROR_OF_MEAN|0.29||0.0735|TWO_SIDED|95.0|-1.09|0.05|||MMRM|||Change from Baseline at Week 12: The null hypothesis was that bimatoprost SR 15 μg was to be declared non-inferior to SLT if the upper limit of the 95% CI was ≤ 1.5 mmHg at all scheduled visits (Weeks 4, 12, and 24).||0.05|-1.09|0.0735
72340736|NCT02636946|144205349|NON_INFERIORITY|MMRM was used for IOP change from baseline. The model includes IOP change from baseline as the response variable and treatment, visit, eye, baseline IOP, treatment-by-baseline, treatment-by-eye, treatment-by-visit, visit-by-eye interactions as covariates. A Kronecker product of unstructured covariance matrix for study visit and compound symmetry covariance matrix for between eye correlation was used in the analysis.|Least-squares Mean Difference|-0.25|STANDARD_ERROR_OF_MEAN|0.29||0.3928|TWO_SIDED|95.0|-0.81|0.32|||MMRM|||Change from Baseline at Week 24: The null hypothesis was that bimatoprost SR 15 μg was to be declared non-inferior to SLT if the upper limit of the 95% confidence interval (CI) was ≤ 1.5 mmHg at all scheduled visits (Weeks 4, 12, and 24).||0.32|-0.81|0.3928
72340737|NCT01792518|144205377|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001|TWO_SIDED|95.0|-0.78|-0.43|||Mixed Models Analysis|The Unstructured covariance structure has been used to fit the mixed model|Mean Difference (Final Values) is actually the Adjusted mean difference calculated as Linagliptin 5 mg minus Placebo.|Superiority of Linagliptin 5 mg vs. placebo: change in HbA1c is analysed using mixed model repeated measures (MMRM) approach. Model includes baseline HbA1c, baseline log10 (UACR), baseline HbA1c by visit and baseline log10 (UACR) by visit as linear covariates and treatment, visit, visit by treatment interaction as fixed effects.||-0.43|-0.78|<0.0001
72340738|NCT01792518|144205378|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|0.94||||0.1954|TWO_SIDED|95.0|0.85|1.03|||ANCOVA||Ratio of relative change for Linagliptin 5 mg over placebo is presented.|Superiority of Linagliptin 5 mg vs. placebo: change in UACR is analysed using analysis of covariance model. Model includes baseline HbA1c and baseline log10 (UACR) as linear covariates and treatment as fixed effect.||1.03|0.85|0.1954
72340739|NCT01792518|144205379|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.63|STANDARD_ERROR_OF_MEAN|2.7||0.3306|TWO_SIDED|95.0|-7.95|2.68|||Mixed Models Analysis|The Unstructured covariance structure has been used to fit the mixed model|Mean Difference (Final Values) is actually the Adjusted mean difference calculated as Linagliptin 5 mg minus Placebo.|Change in eGFR is analysed using mixed model repeated measures (MMRM) approach. Model includes baseline HbA1c, baseline log10 (UACR), baseline eGFR, baseline HbA1c by visit, baseline log10 (UACR) by visit and baseline eGFR by visit as linear covariates and treatment, visit, visit by treatment interaction as fixed effects.||2.68|-7.95|0.3306
72428434|NCT01089556|144367797|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.985||||0.843|TWO_SIDED|95.0|0.842|1.151|||Cochran-Mantel-Haenszel|||||1.151|0.842|0.843
72428435|NCT01089556|144367798|SUPERIORITY_OR_OTHER||LS Mean Difference (Final Values)|-0.341|||<|0.001||95.0|||||Mixed Models Analysis|||||||<0.001
72340740|NCT04468074|144205380|SUPERIORITY||Mean Difference (Net)|1.0||||0.014|TWO_SIDED||||||Mixed Models Analysis|||||||0.014
72340741|NCT04468074|144205381|SUPERIORITY||Mean Difference (Net)|2.79||||0.0159|TWO_SIDED||||||Mixed Models Analysis|||||||0.0159
72340742|NCT04468074|144205382|SUPERIORITY||Median Difference (Net)|-3.85||||0.0066|TWO_SIDED||||||Mixed Models Analysis|||||||0.0066
72428436|NCT01089556|144367799|SUPERIORITY_OR_OTHER||LS Mean Difference (Final Values)|-0.073||||0.475||95.0|||||Mixed Models Analysis|||||||0.475
72428437|NCT01089556|144367800|SUPERIORITY_OR_OTHER||LS Mean Difference (Final Values)|-4.758|||<|0.001||95.0|||||Mixed Models Analysis|||||||<0.001
72340743|NCT00915148|144205405|SUPERIORITY_OR_OTHER||||||<|0.01||||||The reported p-value corresponds with each area under the ROC assessments|Chi-squared|||In a previous study we investigated women before induction of labor. Using 40 mm as cut-off level for fetal head - perineum distance, the Cesarean section rate in primiparous women was 7% in the group with a short distance and 27% in the group with a long distance. We assumed similar results, with alpha 0.05, power 0.8 and a ratio of 1 : 1 for the numbers of women with a long and short distance. We would need to include 110 women in the study.||||<0.01
72340744|NCT00915148|144205406|SUPERIORITY_OR_OTHER||||||<|0.01||||||the reported p-value corresponds with each log rank comparison|Log Rank|||"Kaplan Meier plots were used to compare time from a defined prolonged labor in the first stage to delivery for~1. women with fetal head-perineum distance ≤40 mm vs. women with distance \>40 mm measured with 2D ultrasound.~2. women with angle of progression ≥110 degrees vs. women with angle \<110 degrees measured with 2D ultrasound"||||<0.01
72340745|NCT00351273|144205427|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|40.8||||0.01|TWO_SIDED||||||Fisher Exact|||Difference in the percentages of participants with response between all those who received combination therapy vs. placebo||||0.01
72340746|NCT02033213|144205435|SUPERIORITY_OR_OTHER|||||||0.41||||||P \< 0.05 was considered significant.|t-test, 1 sided|||The measurement was assessed at 10 minutes time point.||||0.410
72340747|NCT02033213|144205435|SUPERIORITY_OR_OTHER|||||||0.621||||||P \< 0.05 was considered significant.|t-test, 1 sided|||The measurement was assessed at 6 hours time point.||||0.621
72340748|NCT02033213|144205436|SUPERIORITY_OR_OTHER|||||||0.791||||||P \< 0.05 was considered significant.|t-test, 1 sided|||The measurement was assessed at 10 minutes time point.||||0.791
72340749|NCT02033213|144205436|SUPERIORITY_OR_OTHER|||||||0.41||||||P \< 0.05 was considered significant.|t-test, 1 sided|||The measurement was assessed at 6 hours time point.||||0.410
72340750|NCT02033213|144205437|SUPERIORITY_OR_OTHER|||||||0.322||||||P \< 0.05 was considered significant.|t-test, 1 sided|||The measurement aws assessed at 10 minutes time point.||||0.322
72340751|NCT02033213|144205437|SUPERIORITY_OR_OTHER|||||||0.574||||||P \< 0.05 was considered significant.|t-test, 1 sided|||The measurement was assessed at 6 hours time point.||||0.574
72340752|NCT02033213|144205438|SUPERIORITY_OR_OTHER|||||||0.03||||||P \< 0.05 was considered significant.|t-test, 1 sided|||||||0.030
72340753|NCT02033213|144205438|SUPERIORITY_OR_OTHER|||||||0.096||||||P \< 0.05 was considered significant.|t-test, 1 sided|||||||0.096
72340754|NCT02033213|144205439|SUPERIORITY_OR_OTHER|||||||0.362|||||||t-test, 1 sided|||||||0.362
72340755|NCT02033213|144205440|SUPERIORITY_OR_OTHER|||||||0.02|||||||t-test, 1 sided|||||||0.020
72340756|NCT03907033|144205453|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Standard Bupivacaine study arm compared to Liposomal Bupivacaine study arm for Hydrocodone use||||1.000
72340757|NCT03907033|144205453|SUPERIORITY|||||||0.01|||||||Wilcoxon (Mann-Whitney)|||Standard Bupivacaine study arm compared to Liposomal Bupivacaine study arm for Oxycodone use||||0.010
72340758|NCT03907033|144205454|SUPERIORITY|||||||0.248|||||||Wilcoxon (Mann-Whitney)|||Standard Bupivacaine study arm compared to Liposomal Bupivacaine study arm for Ibuprofen use||||0.248
72340759|NCT03907033|144205454|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Standard Bupivacaine study arm compared to Liposomal Bupivacaine study arm for Tylenol use||||1.000
72340760|NCT03907033|144205456|SUPERIORITY|||||||0.846|||||||Wilcoxon (Mann-Whitney)|||Standard Bupivacaine study arm compared to Liposomal Bupivacaine study arm 24 hours post-surgery||||0.846
72428438|NCT01089556|144367801|SUPERIORITY_OR_OTHER||LS Mean Difference (Final Values)|-1.933||||0.289||95.0|||||Mixed Models Analysis|||||||0.289
72340761|NCT03907033|144205456|SUPERIORITY|||||||0.49|||||||Wilcoxon (Mann-Whitney)|||Standard Bupivacaine study arm compared to Liposomal Bupivacaine study arm 48 hours post-surgery||||0.490
72340762|NCT03907033|144205456|SUPERIORITY|||||||0.564|||||||Wilcoxon (Mann-Whitney)|||Standard Bupivacaine study arm compared to Liposomal Bupivacaine study arm 72 hours post-surgery||||0.564
72340763|NCT03907033|144205457|SUPERIORITY|||||||0.264|||||||Wilcoxon (Mann-Whitney)|||Standard Bupivacaine study arm compared to Liposomal Bupivacaine arm at 24 hours post-surgery||||0.264
72340764|NCT03907033|144205457|SUPERIORITY|||||||0.97|||||||Wilcoxon (Mann-Whitney)|||Standard Bupivacaine study arm compared to Liposomal Bupivacaine arm at 48 hours post-surgery||||0.970
72340765|NCT03907033|144205457|SUPERIORITY|||||||0.536|||||||Wilcoxon (Mann-Whitney)|||Standard Bupivacaine study arm compared to Liposomal Bupivacaine arm at 72 hours post-surgery||||0.536
72340766|NCT03907033|144205458|SUPERIORITY|||||||0.957|||||||Wilcoxon (Mann-Whitney)|||Standard Bupivacaine study arm compared to Liposomal Bupivacaine study arm at 24 hours post-surgery||||0.957
72340767|NCT03907033|144205458|SUPERIORITY|||||||0.353|||||||Wilcoxon (Mann-Whitney)|||Standard Bupivacaine study arm compared to Liposomal Bupivacaine study arm at 48 hours post-surgery||||0.353
72340768|NCT03907033|144205458|SUPERIORITY|||||||0.165|||||||Wilcoxon (Mann-Whitney)|||Standard Bupivacaine study arm compared to Liposomal Bupivacaine study arm at 72 hours post-surgery||||0.165
72340769|NCT03907033|144205460|SUPERIORITY|||||||0.802|||||||Wilcoxon (Mann-Whitney)|||Standard Bupivacaine study arm compared to Liposomal Bupivacaine study arm at 72 hours post-surgery||||0.802
72340770|NCT03907033|144205460|SUPERIORITY|||||||0.656|||||||Wilcoxon (Mann-Whitney)|||Standard Bupivacaine study arm compared to Liposomal Bupivacaine study arm at 7-10 days post-surgery||||0.656
72340771|NCT01174173|144205462|SUPERIORITY_OR_OTHER|||||||0.0013|TWO_SIDED|||||A two-sided t-test was performed with p-value \< 0.05 was considered statistically significant a priori.|t-test, 2 sided|||||||0.0013
72340772|NCT01174173|144205463|SUPERIORITY_OR_OTHER|||||||0.09|TWO_SIDED|||||A two-sided t-test was performed for change in 6-minute walk test and p-value \< 0.05 was considered statistically significant a priori.|t-test, 2 sided|||||||0.09
72340773|NCT01174173|144205464|SUPERIORITY_OR_OTHER|||||||0.37|TWO_SIDED|||||A two-sided t-test was performed for difference from baseline and 3-month KCCQ score. A p-value of \<0.05 was considered statistically significant a priori.|t-test, 2 sided|||||||0.37
72340774|NCT01174173|144205466|SUPERIORITY_OR_OTHER|||||||0.037|TWO_SIDED||||||t-test, 2 sided|||||||0.037
72340775|NCT01174173|144205467|SUPERIORITY_OR_OTHER|||||||0.66|TWO_SIDED||||||t-test, 2 sided|||||||0.66
72428439|NCT01089556|144367802|SUPERIORITY_OR_OTHER||LS Mean Difference (Final Values)|-1.02||||0.071||95.0|||||ANCOVA|||||||0.071
72428440|NCT01089556|144367803|SUPERIORITY_OR_OTHER||LS Mean Difference (Final Values)|-0.193||||0.78||95.0|||||ANCOVA|||||||0.780
72340776|NCT03938324|144205474|SUPERIORITY|||||||0.0034||||||The two-tailed significance set at 0.05 was not adjusted for multiple outcomes or comparisons. No adjustments for pairwise comparisons were required for the model.|Multi-level mixed effects|Fixed effects were treatment, time, treatment-by time; whereas, random effects were participant and participant-by-time.||Multi-level mixed effects model for longitudinal data to compare treatment group difference in trajectory across 12 months. Group sizes provided at least 80% power to detect a true difference in change trajectories (treatment-by-time interaction effect), assuming a medium effect size, two-tailed tests, and statistical significance set at 0.05. Null hypothesis was no treatment group difference in the trajectory from baseline to 12 months (no significant treatment-by-time effect).||||0.0034
72340777|NCT03938324|144205475|SUPERIORITY|||||||0.5137||||||The two-tailed significance set at 0.05 was not adjusted for multiple outcomes or comparisons. No adjustments for pairwise comparisons were required for the model.|Multi-level mixed effects|Fixed effects were treatment, time, treatment-by time; whereas, random effects were participant and participant-by-time.||Multi-level mixed effects model for longitudinal data to compare treatment group difference in trajectory across 12 months. Group sizes provided at least 80% power to detect a true difference in change trajectories (treatment-by-time interaction effect), assuming a medium effect size, two-tailed tests, and statistical significance set at 0.05. Null hypothesis was no treatment group difference in the trajectory from baseline to 12 months (no significant treatment-by-time effect).||||0.5137
72340778|NCT03938324|144205476|SUPERIORITY|||||||0.4107||||||The two-tailed significance set at 0.05 was not adjusted for multiple outcomes or comparisons. No adjustments for pairwise comparisons were required for the model.|Multi-level mixed effects|Fixed effects were treatment, time, treatment-by time; whereas, random effects were participant and participant-by-time.||Multi-level mixed effects model for longitudinal data to compare treatment group difference in trajectory across 12 months. Group sizes provided at least 80% power to detect a true difference in change trajectories (treatment-by-time interaction effect), assuming a medium effect size, two-tailed tests, and statistical significance set at 0.05. Null hypothesis was no treatment group difference in the trajectory from baseline to 12 months (no significant treatment-by-time effect).||||0.4107
72340779|NCT03938324|144205477|SUPERIORITY|||||||0.1708||||||The two-tailed significance set at 0.05 was not adjusted for multiple outcomes or comparisons. No adjustments for pairwise comparisons were required for the model.|Multi-level mixed effects|Fixed effects were treatment, time, treatment-by time; whereas, random effects were participant and participant-by-time.||Multi-level mixed effects model for longitudinal data to compare treatment group difference in trajectory across 12 months. Group sizes provided at least 80% power to detect a true difference in change trajectories (treatment-by-time interaction effect), assuming a medium effect size, two-tailed tests, and statistical significance set at 0.05. Null hypothesis was no treatment group difference in the trajectory from baseline to 12 months (no significant treatment-by-time effect).||||0.1708
72340780|NCT03938324|144205478|SUPERIORITY|||||||0.7982||||||The two-tailed significance set at 0.05 was not adjusted for multiple outcomes or comparisons. No adjustments for pairwise comparisons were required for the model.|Multi-level mixed effects|Fixed effects were treatment, time, treatment-by time; whereas, random effects were participant and participant-by-time.||Multi-level mixed effects model for longitudinal data to compare treatment group difference in trajectory across 12 months. Group sizes provided at least 80% power to detect a true difference in change trajectories (treatment-by-time interaction effect), assuming a medium effect size, two-tailed tests, and statistical significance set at 0.05. Null hypothesis was no treatment group difference in the trajectory from baseline to 12 months (no significant treatment-by-time effect).||||0.7982
72340781|NCT01073930|144205503|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was demonstrated if the 1-sided 97.5% CI for the treatment difference (PICOPREP minus HalfLytely) was \>-9% for the percentage of responders. Superiority was demonstrated if the 1-sided 97.5% CI for treatment difference was \>0%.|Mean Difference (Net)|9.8|||||ONE_SIDED|97.5|3.4||||||||||3.4|
72340782|NCT01073930|144205504|NON_INFERIORITY_OR_EQUIVALENCE|If the lower bound of the 97.5% confidence interval exceeds -9.0% then PicoPrep will be declared non-inferior to HalfLytely. If the non-inferiority test is satisfied then a test for superiority will be performed by comparing the lower bound of the 97.5% confidence interval with 0.0%. If the lower bound of the confidence interval is above 0.0% then superiority will be declared.|Mean Difference (Net)|10.7|||||ONE_SIDED|97.5|4.9|||||||Ascending colon comparison|||4.9|
72340783|NCT01073930|144205504|NON_INFERIORITY_OR_EQUIVALENCE|If the lower bound of the 97.5% confidence interval exceeds -9.0% then PicoPrep will be declared non-inferior to HalfLytely. If the non-inferiority test is satisfied then a test for superiority will be performed by comparing the lower bound of the 97.5% confidence interval with 0.0%. If the lower bound of the confidence interval is above 0.0% then superiority will be declared.|Mean Difference (Net)|6.6|||||ONE_SIDED|97.5|1.6|||||||Mid colon comparison|||1.6|
72340784|NCT01073930|144205504|NON_INFERIORITY_OR_EQUIVALENCE|If the lower bound of the 97.5% confidence interval exceeds -9.0% then PicoPrep will be declared non-inferior to HalfLytely. If the non-inferiority test is satisfied then a test for superiority will be performed by comparing the lower bound of the 97.5% confidence interval with 0.0%. If the lower bound of the confidence interval is above 0.0% then superiority will be declared.|Mean Difference (Net)|5.2|||||ONE_SIDED|97.5|0.4|||||||Recto-sigmoid colon comparison|||0.4|
72340785|NCT01073930|144205504|NON_INFERIORITY_OR_EQUIVALENCE|If the lower bound of the 97.5% confidence interval exceeds -9.0% then PicoPrep will be declared non-inferior to HalfLytely. If the non-inferiority test is satisfied then a test for superiority will be performed by comparing the lower bound of the 97.5% confidence interval with 0.0%. If the lower bound of the confidence interval is above 0.0% then superiority will be declared.|Mean Difference (Net)|11.4|||||ONE_SIDED|97.5|5.2|||||||Overall: Ascending, mid, and recto-sigmoid colon comparison|||5.2|
72340786|NCT01073930|144205505|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.0001
72340787|NCT01073930|144205506|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Fisher Exact|||||||<0.0001
72340788|NCT01073930|144205507|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.0001
72340789|NCT01073930|144205508|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.0001
72340790|NCT01073930|144205509|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Fisher Exact|||||||<0.0001
72428441|NCT01089556|144367804|SUPERIORITY_OR_OTHER||LS Mean Difference (Final Values)|-0.558||||0.008||95.0||||P-value is for anxiety subscale score.|Mixed Models Analysis|||||||0.008
72340791|NCT01073930|144205510|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Fisher Exact|||||||<0.0001
72340792|NCT01266590|144205517|SUPERIORITY_OR_OTHER|||||||0.0664||95.0|||||Wilcoxon Signed Rank|||||||0.0664
72340793|NCT02198794|144205536|OTHER||Least Square (LS) Mean Difference|-0.6||||0.121|TWO_SIDED|95.0|-1.42|0.17||Threshold for significance at 0.05 level.|ANCOVA|||The statistical model was an analysis of covariance (ANCOVA) with treatment group and dopamine receptor antagonist status at the pre-withdrawal visit as fixed effects and the pre-withdrawal visit value as a covariate.||0.17|-1.42|0.121
72340794|NCT02408523|144205549|SUPERIORITY||Hazard Ratio (HR)|0.54|||<|0.001|TWO_SIDED|95.0|0.377|0.774||Wald's method was used to calculate the p-value, Hazard Ratio (HR) and confidence intervals (CIs).|Regression, Cox|||Comparison of LCM versus Placebo was based on a Cox proportional hazards regression model with an effect for treatment, stratifying for the following combinations of study participants' Baseline PGTCS frequency and Development from interactive response technology (IRT) (\<= 2 per 28 days in the Combined Baseline Period and Pediatric, \<= 2 per 28 days in the Combined Baseline Period and Adult, and \> 2 per 28 days in the Combined Baseline Period). The reference group was Placebo.||0.774|0.377|<0.001
72340795|NCT02408523|144205550|SUPERIORITY||KM seizure free of LCM vs Placebo|14.1|||=|0.011|TWO_SIDED|95.0|3.2|25.1||Superiority of LCM vs Placebo p-value was based on a chi-square test on 1 degree of freedom.|Mantel Haenszel||Stratified difference in proportion of subjects who are seizure-free from PGTCS on Lacosamide (FAS) vs Placebo (FAS).|The key secondary efficacy variable was evaluated using an extended Mantel-Haenszel testing procedure. Baseline PGTCS Frequency from Combined Baseline and development (age from interactive response technology (IRT)) were calculated from IRT.||25.1|3.2|=0.011
72340796|NCT02408523|144205551|SUPERIORITY||Hazard Ratio (HR)|0.683|||=|0.012|TWO_SIDED|95.0|0.507|0.921||Wald's method was used to calculate the p-value, Hazard Ratio (HR) and confidence intervals (CIs).|Regression, Cox|||Comparison of LCM versus Placebo was based on a Cox proportional hazards regression model with an effect for treatment, stratifying for the following combinations of study participants' Baseline PGTCS frequency and Development from interactive response technology (IRT) (\<= 2 per 28 days in the Combined Baseline Period and Pediatric, \<= 2 per 28 days in the Combined Baseline Period and Adult, and \> 2 per 28 days in the Combined Baseline Period). The reference group was Placebo.||0.921|0.507|=0.012
72340797|NCT02252965|144205566|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin of this efficacy outcome measure is -0.4%.|Least Squares (LS) Mean Difference|0.03|||||TWO_SIDED|95.0|-0.1|0.17||||||||0.17|-0.10|
72340798|NCT02252965|144205567|SUPERIORITY_OR_OTHER||Percentage difference|-1.52||||0.674|TWO_SIDED|95.0|-8.6|5.56|||Mantel Haenszel|||||5.56|-8.60|0.674
72340799|NCT00167388|144205577|SUPERIORITY_OR_OTHER|||||||0.571|||||||Wilcoxon (Mann-Whitney)|||Change in mean mesenteric blood flow velocity from pre- to post- feed in the anemic state for babies \<1250 gm||||0.571
72340800|NCT00167388|144205577|SUPERIORITY_OR_OTHER|||||||0.345|||||||Wilcoxon (Mann-Whitney)|||change in peak systolic blood flow velocity from pre-to post feed for babies \<1250 gm while anemic||||0.345
72340801|NCT00167388|144205577|SUPERIORITY_OR_OTHER|||||||0.006|||||||Wilcoxon (Mann-Whitney)|||Change in superior mesenteric artery blood flow velocity from pre- to post- feed in the anemic state for babies \>1250 gm||||0.006
72340802|NCT00167388|144205577|SUPERIORITY_OR_OTHER|||||||0.035|||||||Wilcoxon (Mann-Whitney)|||change in peak systolic blood flow velocity from pre-to post feed for babies \>1250 gm while anemic||||0.035
72340803|NCT00167388|144205577|SUPERIORITY_OR_OTHER|||||||0.91|||||||Wilcoxon (Mann-Whitney)|||Change in mean mesenteric blood flow velocity from pre-to post-feed for babies \<1250 gm after the PRBC transfusion||||0.910
72340804|NCT00167388|144205577|SUPERIORITY_OR_OTHER|||||||0.85|||||||Wilcoxon (Mann-Whitney)|||Change in Peak systolic mesenteric blood flow velocity from pre-to post-feed for babies \<1250 gm after the PRBC transfusion||||0.850
72340805|NCT00167388|144205577|SUPERIORITY_OR_OTHER|||||||0.507|||||||Wilcoxon (Mann-Whitney)|||Change in mean mesenteric blood flow velocity from pre-to post-feed for babies \>1250 gm after the PRBC transfusion||||0.507
72340806|NCT00167388|144205577|SUPERIORITY_OR_OTHER|||||||0.286|||||||Wilcoxon (Mann-Whitney)|||Change in peak systolic mesenteric blood flow velocity from pre-to post-feed for babies \>1250 gm after the PRBC transfusion||||0.286
72340807|NCT05149313|144205584|SUPERIORITY||Difference in percentages|27.88|||<|0.0001|TWO_SIDED|95.0|15.63|40.14|||Cochran-Mantel-Haenszel|||||40.14|15.63|<0.0001
72340808|NCT05149313|144205585|SUPERIORITY||Difference in percentages|17.8||||0.0052|TWO_SIDED|95.0|7.03|28.57|||Cochran-Mantel-Haenszel|||||28.57|7.03|0.0052
72340809|NCT05149313|144205586|SUPERIORITY||Difference in percentages|18.15||||0.0114|TWO_SIDED|95.0|5.47|30.83|||Cochran-Mantel-Haenszel|||||30.83|5.47|0.0114
72340810|NCT00110461|144205624|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.99|||<|0.0001|TWO_SIDED|95.0|-8.49|-3.5|||t-test, 2 sided|||The change scores were analyzed by using ANCOVA model with treatment as a factor and baseline Y-MRS total score as a covariate. For comparing YMRS-Total score in treatment groups at baseline, only treatment was included in the ANOVA model with baseline values as the dependent variable. The LS means obtained from a type III analysis using SAS were used for the treatment comparisons. Two-tailed student's t-tests were used to test differences between the LS means within the ANCOVA or ANOVA model.||-3.5|-8.49|<0.0001
72340811|NCT00110461|144205624|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-8.26|||<|0.0001|TWO_SIDED|95.0|-10.7|-5.77|||t-test, 2 sided|||The change scores were analyzed by using ANCOVA model with treatment as a factor and baseline Y-MRS total score as a covariate. For comparing YMRS-Total score in treatment groups at baseline, only treatment was included in the ANOVA model with baseline values as the dependent variable. The LS means obtained from a type III analysis using SAS were used for the treatment comparisons. Two-tailed student's t-tests were used to test differences between the LS means within the ANCOVA or ANOVA model.||-5.77|-10.7|<0.0001
72340812|NCT00110461|144205625|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-5.89|||<|0.0001|TWO_SIDED|95.0|-8.7|-3.08|||t-test, 2 sided|||Analyses were performed by fitting an ANCOVA model with treatment as factor and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.||-3.08|-8.7|<0.0001
72340813|NCT00110461|144205625|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|11.51|||<|0.0001|TWO_SIDED|95.0|7.99|15.03|||t-test, 2 sided|||Analyses were performed by fitting an ANCOVA model with treatment as factor and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.||15.03|7.99|<0.0001
72340814|NCT00110461|144205626|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|9.3|||<|0.0001|TWO_SIDED|95.0|5.77|12.84|||t-test, 2 sided|||Analyses were performed by fitting an ANCOVA model with treatment as factor and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.||12.84|5.77|<0.0001
72340815|NCT00110461|144205626|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|11.51|||<|0.0001|TWO_SIDED|95.0|7.99|15.03|||t-test, 2 sided|||Analyses were performed by fitting an ANCOVA model with treatment as factor and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.||15.03|7.99|<0.0001
72340816|NCT00110461|144205627|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.81|||<|0.0001|TWO_SIDED|95.0|-1.15|-0.48|||t-test, 2 sided|||Analyses were performed by fitting an ANCOVA model with treatment as factor and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.||-0.48|-1.15|<0.0001
72340817|NCT00110461|144205627|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.26|||<|0.0001||95.0|-1.59|-0.93|||t-test, 2 sided|||Analyses were performed by fitting an ANCOVA model with treatment as factor and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.||-0.93|-1.59|<0.0001
72340818|NCT00110461|144205628|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.28||||0.0767|TWO_SIDED|95.0|-4.81|0.25|||t-test, 2 sided|||Analyses were performed by fitting an ANCOVA model with treatment as factor and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.||0.25|-4.81|0.0767
72340819|NCT00110461|144205628|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.19||||0.3515|TWO_SIDED|95.0|-3.69|1.32|||t-test, 2 sided|||Analyses were performed by fitting an ANCOVA model with treatment as factor and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.||1.32|-3.69|0.3515
72340820|NCT00110461|144205629|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.88|||<|0.0001|TWO_SIDED|95.0|-8.02|-3.73|||t-test, 2 sided|||Analyses were performed by fitting an ANCOVA model with treatment as factor and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.||-3.73|-8.02|<0.0001
72340821|NCT00110461|144205629|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.46|||<|0.0001|TWO_SIDED|95.0|-7.4|-3.32|||t-test, 2 sided|||Analyses were performed by fitting an ANCOVA model with treatment as factor and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.||-3.32|-7.40|<0.0001
72340822|NCT00110461|144205630|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.86|||<|0.0001|TWO_SIDED|95.0|-12.3|-5.43|||t-test, 2 sided|||Analyses were performed by fitting an ANCOVA model with treatment as factor, and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.||-5.43|-12.3|<0.0001
72340823|NCT00110461|144205630|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.23|||<|0.0001|TWO_SIDED|95.0|-11.6|-4.83|||t-test, 2 sided|||Analyses were performed by fitting an ANCOVA model with treatment as factor, and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.||-4.83|-11.6|<0.0001
72340824|NCT00110461|144205631|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.23|||<|0.0001|TWO_SIDED|95.0|5.07|13.93|||t-test, 2 sided|||||13.93|5.07|<0.0001
72340825|NCT00110461|144205631|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|10.0|||<|0.0001|TWO_SIDED|95.0|5.87|14.14|||t-test, 2 sided|||||14.14|5.87|<0.0001
72340826|NCT00110461|144205632|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.7||||0.0003|TWO_SIDED|95.0|-1.08|-0.33|||t-test, 2 sided|||Analyses were performed by fitting an ANCOVA model with treatment as factor and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.||-0.33|-1.08|0.0003
72340827|NCT00110461|144205632|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-1.04|||<|0.0001|TWO_SIDED|95.0|-1.41|-0.66|||t-test, 2 sided|||Analyses were performed by fitting an ANCOVA model with treatment as factor and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.||-0.66|-1.41|<0.0001
72340828|NCT00110461|144205633|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.25||||0.0878|TWO_SIDED|95.0|-0.54|0.04|||t-test, 2 sided|||Analyses were performed by fitting an ANCOVA model with treatment as factor and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.||0.04|-0.54|0.0878
72340829|NCT00110461|144205633|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.26||||0.0752|TWO_SIDED|95.0|-0.55|0.03|||t-test, 2 sided|||Analyses were performed by fitting an ANCOVA model with treatment as factor and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.||0.03|-0.55|0.0752
72428442|NCT01089556|144367804|SUPERIORITY_OR_OTHER||LS Mean Difference (Final Values)|-0.423||||0.031||95.0||||p-value is for depression subscale score.|Mixed Models Analysis|||||||0.031
72428443|NCT01089556|144367805|SUPERIORITY_OR_OTHER||LS Mean Difference (Final Values)|-0.615||||0.049||95.0||||P-value is for anxiety subscale score.|Mixed Models Analysis|||||||0.049
72428444|NCT01089556|144367805|SUPERIORITY_OR_OTHER||LS Mean Difference (Final Values)|-0.378||||0.198||95.0||||P-value is for depression subscale score.|Mixed Models Analysis|||||||0.198
72428445|NCT01089556|144367810|SUPERIORITY_OR_OTHER||LS Mean Difference (Final Values)|-0.343|||<|0.001||95.0|||||Mixed Models Analysis|||||||<0.001
72428446|NCT01089556|144367811|SUPERIORITY_OR_OTHER||LS Mean Difference (Final Values)|-0.095||||0.385||95.0|||||Mixed Models Analysis|||||||0.385
72340830|NCT00110461|144205634|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.19||||0.2553|TWO_SIDED|95.0|-0.51|0.13|||t-test, 2 sided|||Analyses were performed by fitting an ANCOVA model with treatment as factor and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.||0.13|-0.51|0.2553
72340831|NCT00110461|144205634|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.39||||0.0166|TWO_SIDED|95.0|-0.71|-0.07|||t-test, 2 sided|||Analyses were performed by fitting an ANCOVA model with treatment as factor and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.||-0.07|-0.71|0.0166
72340832|NCT00110461|144205635|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.83|||<|0.0001|TWO_SIDED|95.0|-1.16|-0.51|||t-test, 2 sided|||Analyses were performed by fitting an ANCOVA model with treatment as factor and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.||-0.51|-1.16|<0.0001
72340833|NCT00110461|144205635|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-1.18|||<|0.0001|TWO_SIDED|95.0|-1.51|-0.86|||t-test, 2 sided|||Analyses were performed by fitting an ANCOVA model with treatment as factor and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.||-0.86|-1.51|<0.0001
72340834|NCT00110461|144205636|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.76|||<|0.0001|TWO_SIDED|95.0|-1.13|-0.4|||t-test, 2 sided|||Analyses were performed by fitting an ANCOVA model with treatment as factor and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.||-0.40|-1.13|<0.0001
72340835|NCT00110461|144205636|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.97|||<|0.0001|TWO_SIDED|95.0|-1.33|-0.6|||t-test, 2 sided|||Analyses were performed by fitting an ANCOVA model with treatment as factor and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.||-0.60|-1.33|<0.0001
72340836|NCT00110461|144205637|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-1.92||||0.1729|TWO_SIDED|95.0|-4.69|0.85|||t-test, 2 sided|||||0.85|-4.69|0.1729
72340837|NCT00110461|144205637|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.43||||0.75586|TWO_SIDED|95.0|-3.17|2.31|||t-test, 2 sided|||||2.31|-3.17|0.75586
72340838|NCT00110461|144205638|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.76|||<|0.0001|TWO_SIDED|95.0|-6.9|-2.61|||t-test, 2 sided|||Analyses were performed by fitting an ANCOVA model with treatment as factor and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.||-2.61|-6.90|<0.0001
72340839|NCT00110461|144205638|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.64|||<|0.0001|TWO_SIDED|95.0|-6.78|-2.5|||t-test, 2 sided|||Analyses were performed by fitting an ANCOVA model with treatment as factor and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.||-2.50|-6.78|<0.0001
72428447|NCT01089556|144367812|SUPERIORITY_OR_OTHER||LS Mean Difference (Final Values)|-2.02||||0.064||95.0||||P-value is for systolic BP.|ANCOVA|||||||0.064
72340840|NCT00110461|144205639|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.85||||0.0468|TWO_SIDED|95.0|-3.67|-0.03|||t-test, 2 sided|||Analyses were performed by fitting an ANCOVA model with treatment as factor, and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.||-0.03|-3.67|0.0468
72340841|NCT00110461|144205639|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.03||||0.0296|TWO_SIDED|95.0|-3.85|-0.2|||t-test, 2 sided|||Analyses were performed by fitting an ANCOVA model with treatment as factor, and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.||-0.20|-3.85|0.0296
72340842|NCT00110461|144205640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.44||||0.1309|TWO_SIDED|95.0|-3.31|0.43|||t-test, 2 sided|||Analyses were performed by fitting an ANCOVA model with treatment as factor, and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.||0.43|-3.31|0.1309
72340843|NCT00110461|144205640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.64||||0.0058|TWO_SIDED|95.0|-4.51|-0.77|||t-test, 2 sided|||Analyses were performed by fitting an ANCOVA model with treatment as factor, and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.||-0.77|-4.51|0.0058
72340844|NCT00110461|144205641|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.13||||0.043|TWO_SIDED|95.0|-4.2|-0.07|||t-test, 2 sided|||Analyses were performed by fitting an ANCOVA model with treatment as factor, and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.||-0.07|-4.20|0.0430
72340845|NCT00110461|144205641|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.31||||0.7696|TWO_SIDED|95.0|-2.37|1.76|||t-test, 2 sided|||Analyses were performed by fitting an ANCOVA model with treatment as factor, and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.||1.76|-2.37|0.7696
72340846|NCT00110461|144205642|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.07||||0.9418|TWO_SIDED|95.0|-1.73|1.86|||t-test, 2 sided|||Analyses were performed by fitting an ANCOVA model with treatment as factor, and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.||1.86|-1.73|0.9418
72428448|NCT01089556|144367812|SUPERIORITY_OR_OTHER||LS Mean Difference (Final Values)|0.135||||0.843||95.0||||P-value is for diastolic BP.|ANCOVA|||||||0.843
72428449|NCT01089556|144367813|SUPERIORITY_OR_OTHER||LS Mean Difference (Final Values)|-1.329||||0.354||95.0||||P-value is for systolic BP.|ANCOVA|||||||0.354
72340847|NCT00110461|144205642|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.19||||0.19|TWO_SIDED|95.0|-1.67|1.98|||t-test, 2 sided|||Analyses were performed by fitting an ANCOVA model with treatment as factor, and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.||1.98|-1.67|0.19
72340848|NCT00110461|144205643|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.07||||0.9418|TWO_SIDED|95.0|-1.73|1.86|||t-test, 2 sided|||Analyses were performed by fitting an ANCOVA model with treatment as factor, and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.||1.86|-1.73|0.9418
72340849|NCT00110461|144205643|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.19||||0.8377|TWO_SIDED|95.0|-1.61|1.98|||t-test, 2 sided|||Analyses were performed by fitting an ANCOVA model with treatment as factor, and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.||1.98|-1.61|0.8377
72340850|NCT00110461|144205644|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.82||||0.3969|TWO_SIDED|95.0|-2.71|1.08|||t-test, 2 sided|||Analyses were performed by fitting an ANCOVA model with treatment as factor, and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.||1.08|-2.71|0.3969
72340851|NCT00110461|144205644|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.21||||0.2101|TWO_SIDED|95.0|-3.09|0.68|||t-test, 2 sided|||Analyses were performed by fitting an ANCOVA model with treatment as factor, and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.||0.68|-3.09|0.2101
72340852|NCT00110461|144205645|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.05|||<|0.0001|TWO_SIDED|95.0|-10.5|-3.64|||t-test, 2 sided|||Analyses were performed by fitting an ANCOVA model with treatment as factor, and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.||-3.64|-10.5|<0.0001
72340853|NCT00110461|144205645|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.55||||0.0014|TWO_SIDED|95.0|-8.94|-2.16|||t-test, 2 sided|||Analyses were performed by fitting an ANCOVA model with treatment as factor, and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.||-2.16|-8.94|0.0014
72340854|NCT00110461|144205646|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|18.7||||0.0074|TWO_SIDED|95.0|5.01|32.4|||Chi-squared|||Analyzed using a Chi-square test. Ninety five percent confidence intervals for difference in the responder rates are derived from the normal approximation to binomial.||32.40|5.01|0.0074
72340855|NCT00110461|144205646|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|37.55|||<|0.0001|TWO_SIDED|95.0|23.41|51.68|||Chi-squared|||Analyzed using a Chi-square test. Ninety five percent confidence intervals for difference in the responder rates are derived from the normal approximation to binomial.||51.68|23.41|<0.0001
72340856|NCT00110461|144205647|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|23.4||||0.0009|TWO_SIDED|95.0|9.57|37.24|||Chi-squared|||Analyzed using a Chi-square test. Ninety five percent confidence intervals for difference in the responder rates are derived from the normal approximation to binomial.||37.24|9.57|0.0009
72340857|NCT00110461|144205647|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|28.96|||<|0.0001|TWO_SIDED|95.0|15.05|42.87|||Chi-squared|||Analyzed using a Chi-square test. Ninety five percent confidence intervals for difference in the responder rates are derived from the normal approximation to binomial.||42.87|15.05|<0.0001
72340858|NCT00110461|144205648|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.97|||<|0.0001|TWO_SIDED|95.0|-1.29|-0.66|||Cochran-Mantel-Haenszel|||Analyzed using the Cochran-Mantel-Haenszel row mean score statistic by week.||-0.66|-1.29|<0.0001
72340859|NCT00110461|144205648|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.05|||<|0.0001|TWO_SIDED|95.0|-1.39|-0.7|||Cochran-Mantel-Haenszel|||Analyzed using the Cochran-Mantel-Haenszel row mean score statistic by week.||-0.70|-1.39|<0.0001
72340860|NCT00110461|144205649|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.64||||0.002|TWO_SIDED|95.0|-1.04|-0.24|||Cochran-Mantel-Haenszel|||Analyzed using the Cochran-Mantel-Haenszel row mean score statistic by week.||-0.24|-1.04|0.0020
72340861|NCT00110461|144205649|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8||||0.0001|TWO_SIDED|95.0|-1.19|-0.41|||Cochran-Mantel-Haenszel|||||-0.41|-1.19|0.0001
72340862|NCT00110461|144205650|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.61||||0.001|TWO_SIDED|95.0|-0.96|-0.26|||Cochran-Mantel-Haenszel|||Analyzed using the Cochran-Mantel-Haenszel row mean score statistic by week.||-0.26|-0.96|0.0010
72340863|NCT00110461|144205650|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5||||0.0053|TWO_SIDED|95.0|-0.85|-0.16|||Cochran-Mantel-Haenszel|||Analyzed using the Cochran-Mantel-Haenszel row mean score statistic by week.||-0.16|-0.85|0.0053
72340864|NCT00110461|144205651|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.26||||0.1726|TWO_SIDED|95.0|-0.64|0.11|||Cochran-Mantel-Haenszel|||Analyzed using the Cochran-Mantel-Haenszel row mean score statistic by week.||0.11|-0.64|0.1726
72340865|NCT00110461|144205651|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5||||0.0113|TWO_SIDED|95.0|-0.89|-0.12|||Cochran-Mantel-Haenszel|||Analyzed using the Cochran-Mantel-Haenszel row mean score statistic by week.||-0.12|-0.89|0.0113
72340866|NCT00110461|144205652|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.99|||<|0.0001|TWO_SIDED|95.0|-1.31|-0.67|||Cochran-Mantel-Haenszel|||Analyzed using the Cochran-Mantel-Haenszel row mean score statistic by week.||-0.67|-1.31|<0.0001
72340867|NCT00110461|144205652|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.05|||<|0.0001|TWO_SIDED|95.0|-1.39|-0.72|||Cochran-Mantel-Haenszel|||Analyzed using the Cochran-Mantel-Haenszel row mean score statistic by week.||-0.72|-1.39|<0.0001
72340868|NCT00110461|144205653|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.63||||0.003|TWO_SIDED|95.0|-1.04|-0.22|||Cochran-Mantel-Haenszel|||Analyzed using the Cochran-Mantel-Haenszel row mean score statistic by week.||-0.22|-1.04|0.0030
72340869|NCT00110461|144205653|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.79||||0.0001|TWO_SIDED|95.0|-1.18|-0.4|||Cochran-Mantel-Haenszel|||Analyzed using the Cochran-Mantel-Haenszel row mean score statistic by week.||-0.40|-1.18|0.0001
72340870|NCT00364533|144205681|SUPERIORITY_OR_OTHER||LS mean difference of SPID48|91.4|||<|0.001||95.0|49.77|133.07|||ANCOVA|||The study was terminated and did not reach the planned sample size.||133.07|49.77|<0.001
72340871|NCT00364533|144205681|SUPERIORITY_OR_OTHER||LS mean difference of SPID48|81.5|||<|0.001||95.0|38.66|124.29|||ANCOVA|||The study was terminated and did not reach the planned sample size.||124.29|38.66|<0.001
72340872|NCT00364533|144205681|SUPERIORITY_OR_OTHER||LS mean difference of SPID48|81.5|||<|0.001||95.0|39.21|123.8|||ANCOVA|||The study was terminated and did not reach the planned sample size.||123.80|39.21|<0.001
72340873|NCT00364533|144205681|SUPERIORITY_OR_OTHER||LS mean difference of SPID48|82.4|||<|0.001||95.0|38.96|125.88|||ANCOVA|||The study was terminated and did not reach the planned sample size.||125.88|38.96|<0.001
72340874|NCT04135859|144205691|SUPERIORITY||Mean Difference (Final Values)|10.3||||0.023|TWO_SIDED||||||Mixed Models Analysis|||||||.023
72340875|NCT04135859|144205692|SUPERIORITY||Mean Difference (Final Values)|-59.0||||0.06|TWO_SIDED||||||Mixed Models Analysis|||||||.06
72340876|NCT04135859|144205693|SUPERIORITY||Mean Difference (Final Values)|-0.76||||0.43|TWO_SIDED||||||Mixed Models Analysis|||||||.43
72340877|NCT01943552|144205698|SUPERIORITY_OR_OTHER||Mean Difference (Net)|154.9|STANDARD_ERROR_OF_MEAN|32.32|<|0.0001|TWO_SIDED|95.0|91.08|218.63|||ANCOVA||The Mean Difference; nebulized ipratropium minus placebo was estimated by the difference of their adjusted means.|The analysis of covariance (ANCOVA) method was used to compare the change of FEV1 from pre-bronchodilator at baseline to post-nebulization on treatment day 3 between the active arm and the placebo arm, with baseline value as covariate and two stratification factors based on acute bronchodilator responsiveness at baseline and age as main effects.||218.63|91.08|<0.0001
72340878|NCT01943552|144205699|SUPERIORITY_OR_OTHER||Mean Difference (Net)|51.0|STANDARD_ERROR_OF_MEAN|54.48||0.3509|TWO_SIDED|95.0|-56.55|158.46|||ANCOVA||The Mean Difference; nebulized ipratropium minus placebo was estimated by the difference of their adjusted means.|The analysis of covariance (ANCOVA) method was used to compare the change of forced vital capacity (FVC) from pre-bronchodilator at baseline to post-nebulization on treatment day 3 between the active arm and the placebo arm, with baseline value as covariate and two stratification factors based on acute bronchodilator responsiveness at baseline and age as main effects.||158.46|-56.55|0.3509
72340879|NCT01943552|144205700|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.8|STANDARD_ERROR_OF_MEAN|2.18||0.2069|TWO_SIDED|95.0|-1.54|7.07|||ANCOVA||The Mean Difference; nebulized ipratropium minus placebo was estimated by the difference of their adjusted means.|The analysis of covariance (ANCOVA) method was used to compare the change of blood gas analyses from pre-bronchodilator at baseline to post-nebulization on treatment day 3 for PaO2 between the active arm and the placebo arm, with baseline value as covariate and two stratification factors based on acute bronchodilator responsiveness at baseline and age as main effects.||7.07|-1.54|0.2069
72340880|NCT01943552|144205701|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.4|STANDARD_ERROR_OF_MEAN|0.28||0.1899|TWO_SIDED|95.0|-0.19|0.93|||ANCOVA||The Mean Difference; nebulized ipratropium minus placebo was estimated by the difference of their adjusted means.|The analysis of covariance (ANCOVA) method was used to compare the change of blood gas analyses from pre-bronchodilator at baseline to post-nebulization on treatment day 3 for Oxygen saturation between the active arm and the placebo arm, with baseline value as covariate and two stratification factors based on acute bronchodilator responsiveness at baseline and age as main effects.||0.93|-0.19|0.1899
72340881|NCT01943552|144205702|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.4|STANDARD_ERROR_OF_MEAN|0.57||0.4758|TWO_SIDED|95.0|-0.72|1.55|||ANCOVA||The Mean Difference; nebulized ipratropium minus placebo was estimated by the difference of their adjusted means.|The analysis of covariance (ANCOVA) method was used to compare the change of blood gas analyses from pre-bronchodilator at baseline to post-nebulization on treatment day 3 for PaCO2 between the active arm and the placebo arm, with baseline value as covariate and two stratification factors based on acute bronchodilator responsiveness at baseline and age as main effects.||1.55|-0.72|0.4758
72340882|NCT01943552|144205703|SUPERIORITY_OR_OTHER||Cochran-Mantel-Haenszel Test Statistic|1.82||||0.1779|TWO_SIDED||||||Cochran-Mantel-Haenszel|||For main post-operative pulmonary complications, the Cochran-Mantel-Haenszel analysis was performed on the SCS. Mantel-Haenszel test with strata based on acute bronchodilator responsiveness at baseline and age was used to compare the number of patients with main post-operative pulmonary complications between the two arms.||||0.1779
72340883|NCT02855944|144205711|SUPERIORITY||Cox Proportional Hazard|0.639||||0.001|TWO_SIDED|95.0|0.489|0.835|||Regression, Cox|||||0.835|0.489|0.0010
72340884|NCT02855944|144205712|SUPERIORITY||Cox Proportional Hazard|0.665||||0.0017|TWO_SIDED|95.0|0.516|0.858|||Regression, Cox|||||0.858|0.516|0.0017
72340885|NCT02855944|144205715|SUPERIORITY||Cox Proportional Hazard|0.589||||0.0401|TWO_SIDED|95.0|0.356|0.976|||Regression, Cox|||||0.976|0.356|0.0401
72340886|NCT02855944|144205716|SUPERIORITY||Cox Proportional Hazard|0.564||||0.024|TWO_SIDED|95.0|0.343|0.927|||Regression, Cox|||||0.927|0.343|0.0240
72340887|NCT03242018|144205738|SUPERIORITY||Difference in Least Square (LS) Means|-0.29|STANDARD_ERROR_OF_MEAN|0.173||0.0962|TWO_SIDED|95.0|-0.628|0.051|||ANCOVA|||The change from baseline to Week 26 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of mean SBP (\<130, ≥130 mmHg) at screening, and country as fixed effects, and baseline HbA1c as a covariate.||0.051|-0.628|0.0962
72340888|NCT03242018|144205739|SUPERIORITY||Difference in LS Means|0.05|STANDARD_ERROR_OF_MEAN|0.196||0.8124|TWO_SIDED|95.0|-0.338|0.431|||ANCOVA|||The change from baseline to Week 26 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of mean SBP (\<130, ≥130 mmHg) at screening, and country as fixed effects, and baseline HbA1c as a covariate.||0.431|-0.338|0.8124
72340889|NCT03242018|144205740|SUPERIORITY||Difference in LS Means|-0.361|STANDARD_ERROR_OF_MEAN|0.6033||0.5501|TWO_SIDED|95.0|-1.5431|0.822|||ANCOVA|||The change from baseline to Week 26 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of mean SBP (\<130, ≥130 mmHg) at screening, and country as fixed effects, and baseline FPG as a covariate.||0.8220|-1.5431|0.5501
72340890|NCT03242018|144205740|SUPERIORITY||Difference in LS Means|-0.714|STANDARD_ERROR_OF_MEAN|0.5298||0.1779|TWO_SIDED|95.0|-1.7524|0.3246|||ANCOVA|||The change from baseline to Week 26 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of mean SBP (\<130, ≥130 mmHg) at screening, and country as fixed effects, and baseline FPG as a covariate.||0.3246|-1.7524|0.1779
72340891|NCT03242018|144205741|SUPERIORITY||Difference in LS Means|-0.82|STANDARD_ERROR_OF_MEAN|0.703||0.2432|TWO_SIDED|95.0|-2.197|0.557|||ANCOVA|||The change from baseline to Week 26 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of mean SBP (\<130, ≥130 mmHg) at screening, and country as fixed effects, and baseline body weight as a covariate.||0.557|-2.197|0.2432
72340892|NCT03242018|144205741|SUPERIORITY||Difference in LS Means|-1.41|STANDARD_ERROR_OF_MEAN|0.715||0.0487|TWO_SIDED|95.0|-2.81|-0.008|||ANCOVA|||The change from baseline to Week 26 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of mean SBP (\<130, ≥130 mmHg) at screening, and country as fixed effects, and baseline body weight as a covariate.||-0.008|-2.810|0.0487
72340893|NCT03242018|144205742|SUPERIORITY||Difference in LS Means|-2.14|STANDARD_ERROR_OF_MEAN|2.515||0.3954|TWO_SIDED|95.0|-7.066|2.792|||ANCOVA|||The change from baseline to Week 12 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, and country as fixed effects, and baseline SBP as a covariate.||2.792|-7.066|0.3954
72340894|NCT03242018|144205742|SUPERIORITY||Difference in LS Means|-4.4|STANDARD_ERROR_OF_MEAN|2.442||0.0716|TWO_SIDED|95.0|-9.185|0.386|||ANCOVA|||The change from baseline to Week 12 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, and country as fixed effects, and baseline SBP as a covariate.||0.386|-9.185|0.0716
72340895|NCT03242018|144205743|SUPERIORITY||Difference in LS Means|-3.24|STANDARD_ERROR_OF_MEAN|2.103||0.1232|TWO_SIDED|95.0|-7.365|0.881|||ANCOVA|||The change from baseline to Week 12 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of mean SBP (\<130, ≥130 mmHg) at screening, and country as fixed effects, and baseline SBP as a covariate.||0.881|-7.365|0.1232
72340896|NCT03242018|144205743|SUPERIORITY||Difference in LS Means|-5.36|STANDARD_ERROR_OF_MEAN|2.077||0.0098|TWO_SIDED|95.0|-9.433|-1.292|||ANCOVA|||The change from baseline to Week 12 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of mean SBP (\<130, ≥130 mmHg) at screening, and country as fixed effects, and baseline SBP as a covariate.||-1.292|-9.433|0.0098
72340897|NCT03242018|144205744|SUPERIORITY||Percent Difference|-20.37||||0.222|TWO_SIDED|95.0|-44.75|14.77|||ANCOVA|||The change from baseline to Week 26 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of mean SBP (\<130, ≥130 mmHg) at screening, and country as fixed effects, and log-transformed baseline UACR as a covariate.||14.77|-44.75|0.222
72340898|NCT03242018|144205744|SUPERIORITY||Percent Difference|-21.17||||0.1965|TWO_SIDED|95.0|-45.05|13.1|||ANCOVA|||The change from baseline to Week 26 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of mean SBP (\<130, ≥130 mmHg) at screening, and country as fixed effects, and log-transformed baseline UACR as a covariate.||13.10|-45.05|0.1965
72340899|NCT03242018|144205745|SUPERIORITY||Percentage Difference|3.2||||0.242|TWO_SIDED|95.0|-2.17|8.66|||Cochran-Mantel-Haenszel|||Percentage difference between treatment groups using the Cochran-Mantel-Haenszel test stratified by the randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of metformin use at screening (Yes, No), and the randomization strata of mean SBP (\<130, ≥130 mmHg) at screening.||8.66|-2.17|0.2420
72340900|NCT03242018|144205745|SUPERIORITY||Percentage Difference|6.5||||0.0513|TWO_SIDED|95.0|0.04|12.93|||Cochran-Mantel-Haenszel|||Percentage difference between treatment groups using the Cochran-Mantel-Haenszel test stratified by the randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of metformin use at screening (Yes, No), and the randomization strata of mean SBP (\<130, ≥130 mmHg) at screening.||12.93|0.04|0.0513
72340901|NCT03242018|144205746|SUPERIORITY||Percentage Difference|12.0||||0.0066|TWO_SIDED|95.0|3.48|20.61|||Cochran-Mantel-Haenszel|||Percentage difference between treatment groups using the Cochran-Mantel-Haenszel test stratified by the randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of metformin use at screening (Yes, No), and the randomization strata of mean SBP (\<130, ≥130 mmHg) at screening.||20.61|3.48|0.0066
72340902|NCT03242018|144205746|SUPERIORITY||Percentage Difference|13.0||||0.0043|TWO_SIDED|95.0|4.28|21.75|||Cochran-Mantel-Haenszel|||Percentage difference between treatment groups using the Cochran-Mantel-Haenszel test stratified by the randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of metformin use at screening (Yes, No), and the randomization strata of mean SBP (\<130, ≥130 mmHg) at screening.||21.75|4.28|0.0043
72340903|NCT03263780|144205783|SUPERIORITY||Sensitivity|0.25||||0.056|TWO_SIDED|95.0|0.19|0.46||mpMRI vs hrMRI and PET (PIRADS 3-5 \& Gleason 6+)|Durkalski's Chi-square test||We did not present standard deviation as the variability is already incorporated in the provided confidence interval.|mpMRI vs hrMRI and PET (PIRADS 3-5 \& Gleason 6+)||0.46|0.19|0.056
72340904|NCT03263780|144205783|SUPERIORITY||Sensitivity|0.56||||0.56|TWO_SIDED|95.0|0.44|0.78||mpMRI vs hrMRI or PET (PIRADS 3-5 \& Gleason 6+)|Durkalski's Chi-square test||We did not present standard deviation as the variability is already incorporated in the provided confidence interval.|mpMRI vs hrMRI or PET (PIRADS 3-5 \& Gleason 6+)||0.78|0.44|0.56
72340905|NCT03263780|144205783|SUPERIORITY||Sensitivity|0.22||||0.06|TWO_SIDED|95.0|0.17|0.47||mpMRI vs hrMRI and PET (PIRADS 4-5 \& Gleason 6+)|Durkalski's Chi-square test||We did not present standard deviation as the variability is already incorporated in the provided confidence interval.|mpMRI vs hrMRI and PET (PIRADS 4-5 \& Gleason 6+)||0.47|0.17|0.060
72340906|NCT03263780|144205783|SUPERIORITY||Sensitivity|0.5||||0.083|TWO_SIDED|95.0|0.39|0.74||mpMRI vs hrMRI or PET (PIRADS 4-5 \& Gleason 6+)|Durkalski's Chi-square test||We did not present standard deviation as the variability is already incorporated in the provided confidence interval.|mpMRI vs hrMRI or PET (PIRADS 4-5 \& Gleason 6+)||0.74|0.39|0.083
72340907|NCT03263780|144205784|SUPERIORITY||Sensitivity|0.35||||0.096|TWO_SIDED|95.0|0.26|0.65||mpMRI vs hrMRI and PET (PIRADS 3-5 \& Gleason 7+)|Durkalski's Chi-square test||We did not present standard deviation as the variability is already incorporated in the provided confidence interval.|mpMRI vs hrMRI and PET (PIRADS 3-5 \& Gleason 7+)||0.65|0.26|0.096
72340908|NCT03263780|144205784|SUPERIORITY||Sensitivity|0.6||||0.317|TWO_SIDED|95.0|0.46|0.9||mpMRI vs hrMRI or PET (PIRADS 3-5 \& Gleason 7+)|Durkalski's Chi-square test||We did not present standard deviation as the variability is already incorporated in the provided confidence interval.|mpMRI vs hrMRI or PET (PIRADS 3-5 \& Gleason 7+)||0.90|0.46|0.317
72340909|NCT03263780|144205784|SUPERIORITY||Sensitivity|0.3||||0.063|TWO_SIDED|95.0|0.23|0.66||mpMRI vs hrMRI and PET (PIRADS 4-5 \& Gleason 7+)|Durkalski's Chi-square test||We did not present standard deviation as the variability is already incorporated in the provided confidence interval.|mpMRI vs hrMRI and PET (PIRADS 4-5 \& Gleason 7+)||0.66|0.23|0.063
72340910|NCT03263780|144205784|SUPERIORITY||Sensitivity|0.6||||0.317|TWO_SIDED|95.0|0.46|0.9||mpMRI vs hrMRI or PET (PIRADS 4-5 \& Gleason 7+)|Durkalski's Chi-square test||We did not present standard deviation as the variability is already incorporated in the provided confidence interval.|mpMRI vs hrMRI or PET (PIRADS 4-5 \& Gleason 7+)||0.90|0.46|0.317
72340911|NCT00903331|144205791|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.0||||0.9631|TWO_SIDED|95.0|-0.09|0.08|||Wilcoxon Rank Sum|||The null hypothesis was that there was no difference between ACT-064922 and placebo for the change in FVC from baseline to the end of Period 1. The aim was to detect a placebo-corrected change in FVC of ≥ 0.1 L (Standard Deviation = 0.2 L) at a two-sided 0.05 type 1 error level and 80% power.||0.08|-0.09|0.9631
72340912|NCT00903331|144205792|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.118||||0.7056|TWO_SIDED|95.0|0.626|1.996|||Log Rank|||||1.996|0.626|0.7056
72340913|NCT00257660|144205814|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-8.84|||<|0.0001|TWO_SIDED|95.0|-12.94|-4.74||A hierarchical testing procedure was applied for the primary and secondary outcome measures ranked in the order of priority listed. At each step of the hierarchical testing procedure, there was one comparison and p\<0.05 was considered significant.|ANCOVA|Treatment group, baseline TWSTRS score, center and previous treatment by botulinum toxin or not were fitted in the ANCOVA model.|"Baseline TWSTRS total scores are analysed for all subjects of ITT population, while the analysis at Week 4 excludes the scores for the 7 subjects who were not assessed.~Mean difference = difference in adjusted least squares mean (Dysport - Placebo)."|||-4.74|-12.94|<0.0001
72340914|NCT00257660|144205815|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-8.81|||<|0.0001||95.0|-12.91|-4.71||A hierarchical testing procedure was applied for the primary and secondary outcome measures ranked in the order of priority listed. At each step of the hierarchical testing procedure, there was one comparison and p\<0.05 was considered significant.|ANCOVA|Treatment group, baseline TWSTRS score, center and previous treatment by botulinum toxin or not were fitted in the ANCOVA model.|"Baseline TWSTRS total scores are analysed for all subjects of ITT population, while the Week 8 analysis excludes the scores for the 24 subjects who were not assessed.~Mean difference = difference in adjusted least squares mean (Dysport - Placebo)."|||-4.71|-12.91|<0.0001
72340915|NCT00257660|144205816|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-4.12||||0.019||95.0|-7.55|-0.68||A hierarchical testing procedure was applied for the primary and secondary outcome measures ranked in the order of priority listed. At each step of the hierarchical testing procedure, there was one comparison and p\<0.05 was considered significant.|ANCOVA|Treatment group, baseline TWSTRS score, center and previous treatment by botulinum toxin or not were fitted in the ANCOVA model.|"Baseline TWSTRS total scores are analysed for all subjects of ITT population, while the Week 12 analysis excludes the scores for the 27 subjects who were not assessed.~Mean difference = difference in adjusted least squares mean (Dysport - Placebo)."|||-0.68|-7.55|0.019
72340916|NCT00257660|144205817|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-15.2|||<|0.001||95.0|-24.0|-6.4||A hierarchical testing procedure was applied for the primary and secondary outcome measures ranked in the order of priority listed. At each step of the hierarchical testing procedure, there was one comparison and p\<0.05 was considered significant.|ANCOVA|Treatment group, baseline Subject VAS symptom score, center and previous treatment by botulinum toxin or not were fitted in the ANCOVA model.|Analysis at baseline (and on change at Week 4) excludes 4 subjects (and 13 subjects respectively) of ITT population who were not assessed. Mean difference=difference in adjusted least squares mean (Dysport-placebo)|||-6.4|-24.0|<0.001
72340917|NCT00257660|144205818|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-14.2|||<|0.001||95.0|-22.3|-6.1||A hierarchical testing procedure was applied for the primary and secondary outcome measures ranked in the order of priority listed. At each step of the hierarchical testing procedure, there was one comparison and p\<0.05 was considered significant.|ANCOVA|Treatment group, baseline Investigator VAS CD symptom score, center and previous treatment by botulinum toxin or not were fitted in the ANCOVA model.|Analysis at baseline (and on change at Week 4) excludes 3 subjects (and 8 subjects respectively) of ITT population who were not assessed. Mean difference=difference in adjusted least squares mean (Dysport-placebo)|||-6.1|-22.3|<0.001
72340918|NCT00257660|144205819|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-16.95|||<|0.001||95.0|-25.8|-8.1||A hierarchical testing procedure was applied for the primary and secondary outcome measures ranked in the order of priority listed. At each step of the hierarchical testing procedure, there was one comparison and p\<0.05 was considered significant.|ANCOVA|Treatment group, baseline Subject VAS Pain score, center and previous treatment by botulinum toxin or not were fitted in the ANCOVA model.|Analysis at baseline (and on change at Week 8) excludes 4 subjects (and 4 subjects respectively) of ITT population who were not assessed. Mean difference=difference in adjusted least squares mean (Dysport-placebo)|||-8.1|-25.8|<0.001
72340919|NCT00257660|144205820|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-16.0|||<|0.001||95.0|-24.2|-7.8||A hierarchical testing procedure was applied for the primary and secondary outcome measures ranked in the order of priority listed. At each step of the hierarchical testing procedure, there was one comparison and p\<0.05 was considered significant.|ANCOVA|Treatment group, baseline Investigator VAS Pain score, center and previous treatment by botulinum toxin or not were fitted in the ANCOVA model.|Analysis at baseline (and on change at Week 8) excludes 3 subjects (and 3 subjects respectively) of ITT population who were not assessed. Mean difference=difference in adjusted least squares mean (Dysport-placebo)|||-7.8|-24.2|<0.001
72340920|NCT00257660|144205821|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-11.05||||0.007||95.0|-19.0|-3.1||A hierarchical testing procedure was applied for the primary and secondary outcome measures ranked in the order of priority listed. At each step of the hierarchical testing procedure, there was one comparison and p\<0.05 was considered significant.|ANCOVA|Treatment group, baseline Subject VAS Pain score, center and previous treatment by botulinum toxin or not were fitted in the ANCOVA model.|Analysis at baseline (and on change at Week 12) excludes 4 subjects (and 4 subjects respectively) of ITT population who were not assessed. Mean difference=difference in adjusted least squares mean (Dysport-placebo)|||-3.1|-19.0|0.007
72428450|NCT01089556|144367813|SUPERIORITY_OR_OTHER||LS Mean Difference (Final Values)|-0.003||||0.997||95.0||||P-value is for diastolic BP.|ANCOVA|||||||0.997
72428451|NCT01089556|144367814|SUPERIORITY_OR_OTHER||LS Mean Difference (Final Values)|3.317|||<|0.001||95.0|||||ANCOVA|||||||<0.001
72340921|NCT00257660|144205822|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-7.05||||0.028||95.0|-13.3|-0.8||A hierarchical testing procedure was applied for the primary and secondary outcome measures ranked in the order of priority listed. At each step of the hierarchical testing procedure, there was one comparison and p\<0.05 was considered significant.|ANCOVA|Treatment group, baseline Investigator VAS Pain score, center and previous treatment by botulinum toxin or not were fitted in the ANCOVA model.|Analysis at baseline (and on change at Week 12) excludes 3 subjects (and 3 subjects respectively) of ITT population who were not assessed. Mean difference=difference in adjusted least squares mean (Dysport-placebo)|||-0.8|-13.3|0.028
72340922|NCT00257660|144205823|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|3.65||||0.061||95.0|-0.17|7.47||A hierarchical testing procedure was applied for the primary and secondary outcome measures ranked in the order of priority listed. At each step of the hierarchical testing procedure, there was one comparison and p\<0.05 was considered significant.|ANCOVA|Treatment group, baseline SF-36 mental health summary score, center and previous treatment by botulinum toxin or not were fitted in the ANCOVA model.|Analysis at baseline (and on change at Week 8) excludes 3 subjects (and 37 subjects respectively) of ITT population who were not assessed. Mean difference=difference in adjusted least squares mean (Dysport-placebo)|||7.47|-0.17|0.061
72340923|NCT00257660|144205824|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|4.66||||0.002||95.0|1.73|7.58||A hierarchical testing procedure was applied for the primary and secondary outcome measures ranked in the order of priority listed. At each step of the hierarchical testing procedure, there was one comparison and p\<0.05 was considered significant.|ANCOVA|Treatment group, baseline SF-36 physical health summary score, center and previous treatment by botulinum toxin or not were fitted in ANCOVA model.|Analysis at baseline (and on change at Week 8) excludes 3 subjects (and 37 subjects respectively) of ITT population who were not assessed. Mean difference=difference in adjusted least squares mean (Dysport-placebo)|||7.58|1.73|0.002
72340924|NCT00257660|144205825|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|7.206|||<|0.0001||95.0|3.01|17.26||A hierarchical testing procedure was applied for the primary and secondary outcome measures ranked in the order of priority listed. At each step of the hierarchical testing procedure, there was one comparison and p\<0.05 was considered significant.|odds ratio|The odds ratio represents the odds of success on Dysport versus Placebo stratified for strata and country||The number of participants considered treatment successes was analysed using a logistic model with treatment, strata (naive or non-naive) and center as factors in the model.||17.26|3.01|<0.0001
72340925|NCT02449018|144205833|SUPERIORITY||Mean Difference (Net)|0.28|STANDARD_DEVIATION|0.31||0.13|TWO_SIDED|90.0|-0.24|0.79|||ANCOVA|||||0.79|-0.24|0.130
72340926|NCT03995355|144205846|NON_INFERIORITY|Subjective overall comfort was analyzed using linear mixed model. Statistical inference was made based on the 95% confidence interval constructed for the least square mean difference.|Least square mean difference|11.3|STANDARD_ERROR_OF_MEAN|4.44|||TWO_SIDED|95.0|2.6|20.1|||Linear Mixed Model Analysis||Least square mean difference was calculated as Test minus Control|||20.1|2.6|
72340927|NCT03995355|144205847|NON_INFERIORITY|Subjective overall comfort was analyzed using linear mixed model. Statistical inference was made based on the 95% confidence interval constructed for the least square mean difference.|Least square mean difference|2.6|STANDARD_ERROR_OF_MEAN|3.97|||TWO_SIDED|95.0|-5.3|10.4|||Linear Mixed Model Analysis|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.|Least square mean difference was calculated as Test minus Control|||10.4|-5.3|
72340928|NCT03995355|144205848|OTHER||Odds Ratio (OR)|0.967|||||TWO_SIDED|95.0|0.528|1.77|||Generalized linear Mixed Model Analysis||Odds ratio was calculated as Test over Control. No difference was concluded if 1 fall within the 95% confidence interval for the odds ratio.|||1.770|0.528|
72340929|NCT03995355|144205848|OTHER||Odds Ratio (OR)|1.16|||||TWO_SIDED|95.0|0.61|2.203|||Generalized linear Mixed Model Analysis||Odds ratio was calculated as Test over Control. No difference was concluded if 1 fall within the 95% confidence interval for the odds ratio.|30-Day follow-up||2.203|0.610|
72340930|NCT03995355|144205849|OTHER||Odds Ratio (OR)|1.601|||||TWO_SIDED|95.0|0.178|19.616|||Fisher Exact||Odds ratio was calculated as Test over Control|||19.616|0.178|
72340931|NCT03995355|144205850|OTHER||Mean Difference (Net)|8.0|STANDARD_ERROR_OF_MEAN|3.73|||TWO_SIDED|95.0|0.7|15.4|||Linear Mixed Model Analysis|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.|Least square mean difference was calculated as Test minus Control|||15.4|0.7|
72340932|NCT03995355|144205851|OTHER||Mean Difference (Net)|9.3|STANDARD_ERROR_OF_MEAN|3.86|||TWO_SIDED|95.0|1.7|17.0|||Linear Mixed Model Analysis|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.|Least square mean difference was calculated as Test minus Control|||17.0|1.7|
72340933|NCT03426631|144205852|SUPERIORITY||Median Difference (Final Values)|-11.7||||0.47|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.47
72340934|NCT05063539|144205858|SUPERIORITY||Posterior Mean Difference|1.68|||||TWO_SIDED|95.0|-0.375|3.771|||||Posterior mean difference with 95% credible interval is reported.|||3.771|-0.375|
72340935|NCT05063539|144205858|SUPERIORITY||Posterior Mean Difference|-3.2|||||TWO_SIDED|95.0|-5.354|-1.042|||||Posterior mean difference with 95% credible interval is reported.|||-1.042|-5.354|
72340936|NCT05063539|144205859|SUPERIORITY||Posterior Mean Difference|1.59|||||TWO_SIDED|95.0|-0.443|3.697|||||Posterior mean difference with 95% credible interval is reported.|||3.697|-0.443|
72340937|NCT05063539|144205859|SUPERIORITY||Posterior Mean Difference|-5.07|||||TWO_SIDED|95.0|-7.277|-2.862||||||||-2.862|-7.277|
72340938|NCT05063539|144205860|SUPERIORITY||LS Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.32||0.665|TWO_SIDED|95.0|-0.763|0.488|||NCS2|A NCS model with 2 degrees of freedom (NCS2) was used.||||0.488|-0.763|0.665
72340939|NCT05063539|144205860|SUPERIORITY||LS Mean Difference|1.09|STANDARD_ERROR_OF_MEAN|0.33||0.001|TWO_SIDED|95.0|0.435|1.736|||NCS2|A NCS model with 2 degrees of freedom (NCS2) was used.||||1.736|0.435|0.001
72340940|NCT05063539|144205861|SUPERIORITY||LS Mean Difference|0.05|STANDARD_ERROR_OF_MEAN|0.35||0.878|TWO_SIDED|95.0|-0.641|0.749|||NCS2|A NCS model with 2 degrees of freedom (NCS2) was used.||||0.749|-0.641|0.878
72340941|NCT05063539|144205861|SUPERIORITY||LS Mean Difference|1.33|STANDARD_ERROR_OF_MEAN|0.36|<|0.001|TWO_SIDED|95.0|0.615|2.05|||NCS2|A NCS model with 2 degrees of freedom (NCS2) was used.||||2.050|0.615|<0.001
72340942|NCT05063539|144205862|SUPERIORITY||LS Mean Difference|-1.13|STANDARD_ERROR_OF_MEAN|0.99||0.252|TWO_SIDED|95.0|-3.073|0.811|||NCS2|A NCS model with 2 degrees of freedom (NCS2) was used.||||0.811|-3.073|0.252
72428452|NCT01089556|144367815|SUPERIORITY_OR_OTHER||LS Mean Difference (Final Values)|-0.942||||0.332||95.0|||||ANCOVA|||||||0.332
72340943|NCT05063539|144205862|SUPERIORITY||LS Mean Difference|-0.23|STANDARD_ERROR_OF_MEAN|1.03||0.825|TWO_SIDED|95.0|-2.252|1.797|||NCS2|A NCS model with 2 degrees of freedom (NCS2) was used.||||1.797|-2.252|0.825
72340944|NCT05063539|144205863|SUPERIORITY||LS Mean Difference|-0.37|STANDARD_ERROR_OF_MEAN|1.09||0.733|TWO_SIDED|95.0|-2.527|1.779|||NCS2|A NCS model with 2 degrees of freedom (NCS2) was used.||||1.779|-2.527|0.733
72340945|NCT05063539|144205863|SUPERIORITY||LS Mean Difference|1.66|STANDARD_ERROR_OF_MEAN|1.13||0.143|TWO_SIDED|95.0|-0.565|3.877|||NCS2|A NCS model with 2 degrees of freedom (NCS2) was used.||||3.877|-0.565|0.143
72340946|NCT05063539|144205864|SUPERIORITY||LS Mean Difference|0.18|STANDARD_ERROR_OF_MEAN|1.0||0.86|TWO_SIDED|95.0|-1.802|2.158|||NCS2|A NCS model with 2 degrees of freedom (NCS2) was used.||||2.158|-1.802|0.860
72340947|NCT05063539|144205864|SUPERIORITY||LS Mean Difference|-2.51|STANDARD_ERROR_OF_MEAN|1.04||0.017|TWO_SIDED|95.0|-4.567|-0.456|||NCS2|A NCS model with 2 degrees of freedom (NCS2) was used.||||-0.456|-4.567|0.017
72340948|NCT05063539|144205865|SUPERIORITY||LS Mean Difference|-0.78|STANDARD_ERROR_OF_MEAN|1.1||0.479|TWO_SIDED|95.0|-2.949|1.387|||NCS2|A NCS model with 2 degrees of freedom (NCS2) was used.||||1.387|-2.949|0.479
72340949|NCT05063539|144205865|SUPERIORITY||LS Mean Difference|-4.01|STANDARD_ERROR_OF_MEAN|1.13|<|0.001|TWO_SIDED|95.0|-6.239|-1.788|||NCS2|A NCS model with 2 degrees of freedom (NCS2) was used.||||-1.788|-6.239|<0.001
72340950|NCT05063539|144205866|SUPERIORITY||LS Mean Difference|0.6|STANDARD_ERROR_OF_MEAN|0.53||0.259|TWO_SIDED|95.0|-0.445|1.642|||NCS2|A NCS model with 2 degrees of freedom (NCS2) was used.||||1.642|-0.445|0.259
72340951|NCT05063539|144205866|SUPERIORITY||LS Mean Difference|-0.54|STANDARD_ERROR_OF_MEAN|0.55||0.324|TWO_SIDED|95.0|-1.629|0.541|||NCS2|A NCS model with 2 degrees of freedom (NCS2) was used.||||0.541|-1.629|0.324
72340952|NCT05063539|144205867|SUPERIORITY||LS Mean Difference|0.18|STANDARD_ERROR_OF_MEAN|0.57||0.749|TWO_SIDED|95.0|-0.946|1.313|||NCS2|A NCS model with 2 degrees of freedom (NCS2) was used.||||1.313|-0.946|0.749
72340953|NCT05063539|144205867|SUPERIORITY||LS Mean Difference|-1.3|STANDARD_ERROR_OF_MEAN|0.59||0.029|TWO_SIDED|95.0|-2.462|-0.134|||NCS2|A NCS model with 2 degrees of freedom (NCS2) was used.||||-0.134|-2.462|0.029
72340954|NCT05063539|144205868|SUPERIORITY||LS Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.012||0.346|TWO_SIDED|95.0|-0.01|0.03|||ANCOVA|||Frontal||0.03|-0.01|0.346
72340955|NCT05063539|144205868|SUPERIORITY||LS Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.013||0.412|TWO_SIDED|95.0|-0.04|0.01|||ANCOVA|||Frontal||0.01|-0.04|0.412
72340956|NCT05063539|144205868|SUPERIORITY||LS Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.013||0.421|TWO_SIDED|95.0|-0.04|0.02|||ANCOVA|||Parietal||0.02|-0.04|0.421
72340957|NCT05063539|144205868|SUPERIORITY||LS Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.014||0.08|TWO_SIDED|95.0|-0.05|0.0|||ANCOVA|||Parietal||0.00|-0.05|0.080
72340958|NCT05063539|144205868|SUPERIORITY||LS Mean Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.021||0.192|TWO_SIDED|95.0|-0.07|0.01|||ANCOVA|||Lateral occipital||0.01|-0.07|0.192
72340959|NCT05063539|144205868|SUPERIORITY||LS Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.022||0.279|TWO_SIDED|95.0|-0.07|0.02|||ANCOVA|||Lateral occipital||0.02|-0.07|0.279
72340960|NCT05063539|144205868|SUPERIORITY||LS Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.016||0.693|TWO_SIDED|95.0|-0.04|0.02|||ANCOVA|||Lateral temporal||0.02|-0.04|0.693
72340961|NCT05063539|144205868|SUPERIORITY||LS Mean Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.016||0.04|TWO_SIDED|95.0|-0.07|0.0|||ANCOVA|||Lateral temporal||-0.00|-0.07|0.040
72340962|NCT05063539|144205868|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.015||0.838|TWO_SIDED|95.0|-0.03|0.03|||ANCOVA|||AD neocortical signature (measured using MUBADA)||0.03|-0.03|0.838
72340963|NCT05063539|144205868|SUPERIORITY||LS Mean Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.016||0.055|TWO_SIDED|95.0|-0.06|0.0|||ANCOVA|||AD neocortical signature (measured using MUBADA)||0.00|-0.06|0.055
72340964|NCT05063539|144205869|SUPERIORITY||LS Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.013||0.455|TWO_SIDED|95.0|-0.02|0.04|||ANCOVA|||Frontal||0.04|-0.02|0.455
72340965|NCT05063539|144205869|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.014||0.745|TWO_SIDED|95.0|-0.03|0.02|||ANCOVA|||Frontal||0.02|-0.03|0.745
72340966|NCT05063539|144205869|SUPERIORITY||LS Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.015||0.676|TWO_SIDED|95.0|-0.02|0.04|||ANCOVA|||Parietal||0.04|-0.02|0.676
72340967|NCT05063539|144205869|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.015||0.794|TWO_SIDED|95.0|-0.03|0.03|||ANCOVA|||Parietal||0.03|-0.03|0.794
72340968|NCT05063539|144205869|SUPERIORITY||LS Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.021||0.643|TWO_SIDED|95.0|-0.05|0.03|||ANCOVA|||Lateral occipital||0.03|-0.05|0.643
72340969|NCT05063539|144205869|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.021||0.88|TWO_SIDED|95.0|-0.05|0.04|||ANCOVA|||Lateral occipital||0.04|-0.05|0.880
72340970|NCT05063539|144205869|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.017||0.844|TWO_SIDED|95.0|-0.04|0.03|||ANCOVA|||Lateral temporal||0.03|-0.04|0.844
72340971|NCT05063539|144205869|SUPERIORITY|Lateral temporal|LS Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.017||0.388|TWO_SIDED|95.0|-0.05|0.02|||ANCOVA|||||0.02|-0.05|0.388
72340972|NCT05063539|144205869|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.016||0.815|TWO_SIDED|95.0|-0.03|0.04|||ANCOVA|||AD neocortical signature (measured using MUBADA)||0.04|-0.03|0.815
72340973|NCT05063539|144205869|SUPERIORITY||LS Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.017||0.562|TWO_SIDED|95.0|-0.04|0.02|||ANCOVA|||AD neocortical signature (measured using MUBADA)||0.02|-0.04|0.562
72340974|NCT05063539|144205870|SUPERIORITY||LS Mean Difference|0.09|STANDARD_ERROR_OF_MEAN|0.024|<|0.001|TWO_SIDED|95.0|0.04|0.14|||Mixed Models Analysis|||Bilateral Hippocampus||0.14|0.04|<0.001
72340975|NCT05063539|144205870|SUPERIORITY||LS Mean Difference|0.13|STANDARD_ERROR_OF_MEAN|0.025|<|0.001|TWO_SIDED|95.0|0.08|0.18|||Mixed Models Analysis|||Bilateral Hippocampus||0.18|0.08|<0.001
72340976|NCT05063539|144205870|SUPERIORITY||LS Mean Difference|-2.37|STANDARD_ERROR_OF_MEAN|0.587|<|0.001|TWO_SIDED|95.0|-3.53|-1.21|||Mixed Models Analysis|||Bilateral Whole Lateral Ventricles||-1.21|-3.53|<0.001
72340977|NCT05063539|144205870|SUPERIORITY||LS Mean Difference|-1.64|STANDARD_ERROR_OF_MEAN|0.611||0.008|TWO_SIDED|95.0|-2.84|-0.43|||Mixed Models Analysis|||Bilateral Whole Lateral Ventricles||-0.43|-2.84|0.008
72340978|NCT05063539|144205870|SUPERIORITY||LS Mean Difference|8.17|STANDARD_ERROR_OF_MEAN|1.715|<|0.001|TWO_SIDED|95.0|4.79|11.56|||Mixed Models Analysis|||Bilateral Whole Brain||11.56|4.79|<0.001
72428453|NCT01089556|144367816|SUPERIORITY_OR_OTHER|||||||0.618||95.0|||||Fisher Exact|||||||0.618
72340979|NCT05063539|144205870|SUPERIORITY||LS Mean Difference|9.37|STANDARD_ERROR_OF_MEAN|1.804|<|0.001|TWO_SIDED|95.0|5.81|12.92|||Mixed Models Analysis|||Bilateral Whole Brain||12.92|5.81|<0.001
72340980|NCT05063539|144205871|SUPERIORITY||LS Mean Difference|0.08|STANDARD_ERROR_OF_MEAN|0.023|<|0.001|TWO_SIDED|95.0|0.04|0.13|||Mixed Models Analysis|||Bilateral Hippocampus||0.13|0.04|<0.001
72340981|NCT05063539|144205871|SUPERIORITY|Bilateral Hippocampus|LS Mean Difference|0.12|STANDARD_ERROR_OF_MEAN|0.023|<|0.001|TWO_SIDED|95.0|0.08|0.17|||Mixed Models Analysis|||||0.17|0.08|<0.001
72340982|NCT05063539|144205871|SUPERIORITY||LS Mean Difference|-2.21|STANDARD_ERROR_OF_MEAN|0.57|<|0.001|TWO_SIDED|95.0|-3.33|-1.08|||Mixed Models Analysis|||Bilateral Whole Lateral Ventricles||-1.08|-3.33|<0.001
72340983|NCT05063539|144205871|SUPERIORITY||LS Mean Difference|-1.42|STANDARD_ERROR_OF_MEAN|0.582||0.015|TWO_SIDED|95.0|-2.57|-0.28|||Mixed Models Analysis|||Bilateral Whole Lateral Ventricles||-0.28|-2.57|0.015
72340984|NCT05063539|144205871|SUPERIORITY||LS Mean Difference|7.17|STANDARD_ERROR_OF_MEAN|1.635|<|0.001|TWO_SIDED|95.0|3.95|10.4|||Mixed Models Analysis|||Bilateral Whole Brain||10.40|3.95|<0.001
72340985|NCT05063539|144205871|SUPERIORITY||LS Mean Difference|8.16|STANDARD_ERROR_OF_MEAN|1.68|<|0.001|TWO_SIDED|95.0|4.85|11.47|||Mixed Models Analysis|||Bilateral Whole Brain||11.47|4.85|<0.001
72340986|NCT04736628|144205909|OTHER||Mean Difference (Net)|-0.228||||0.0179|TWO_SIDED|95.0|-0.417|-0.04|||Mixed-effect Model repeat Measurement||"Least Squares Mean of Avenciguat 1 mg TID - Least Squares Mean of Placebo."|Least Squares Mean differences and 95% confidence intervals were estimated by restricted maximum likelihood (REML)-based mixed-effect model for repeated measures (MMRM) including the fixed, categorical effects of treatment at each visit (baseline, Week 6, Week 12 and Week 20), and the continuous effect of baseline at each visit (Week 6, Week 12, and Week 20) as well as random effects of patient.||-0.040|-0.417|0.0179
72340987|NCT04736628|144205909|OTHER||Mean Difference (Net)|-0.209||||0.0307|TWO_SIDED|95.0|-0.398|-0.02|||Mixed-effect Model repeat Measurement||"Least Squares Mean of Avenciguat 2 mg TID - Least Squares Mean of Placebo."|Least Squares Mean differences and 95% confidence intervals were estimated by restricted maximum likelihood (REML)-based mixed-effect model for repeated measures (MMRM) including the fixed, categorical effects of treatment at each visit (baseline, Week 6, Week 12 and Week 20), and the continuous effect of baseline at each visit (Week 6, Week 12, and Week 20) as well as random effects of patient.||-0.020|-0.398|0.0307
72340988|NCT04736628|144205909|OTHER||Mean Difference (Net)|-0.235||||0.0151|TWO_SIDED|95.0|-0.425|-0.046|||Mixed-effect Model repeat Measurement||"Least Squares Mean of Avenciguat 3 mg TID - Least Squares Mean of Placebo."|Least Squares Mean differences and 95% confidence intervals were estimated by restricted maximum likelihood (REML)-based mixed-effect model for repeated measures (MMRM) including the fixed, categorical effects of treatment at each visit (baseline, Week 6, Week 12 and Week 20), and the continuous effect of baseline at each visit (Week 6, Week 12, and Week 20) as well as random effects of patient.||-0.046|-0.425|0.0151
72340989|NCT04736628|144205909|OTHER|MMRM estimates were used as input for the MCP-Mod. MMRM included the fixed, categorical effects of treatment at each visit (baseline, Week 6, Week 12 and Week 20), and the continuous effect of baseline at each visit (Week 6, Week 12, and Week 20) as well as random effects of patient.||||||0.0053|||||||MCP-Mod E-max model fit|Model assumption: 80% of the maximum effect is achieved at 6 mg.||"A flat vs. non-flat dose-response relationship across the 3 doses of avenciguat and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (Emax, exponential, linear, quadratic, sigmoid emax) while protecting the overall probability of type I error (one-sided alpha of 0.050).~The total daily dose was considered for MCP-Mod analysis (placebo, active avenciguat 3 mg, 6 mg, and 9 mg)."||||0.0053
72340990|NCT04736628|144205909|OTHER|MMRM estimates were used as input for the MCP-Mod. MMRM included the fixed, categorical effects of treatment at each visit (baseline, Week 6, Week 12 and Week 20), and the continuous effect of baseline at each visit (Week 6, Week 12, and Week 20) as well as random effects of patient.||||||0.0102|||||||MCP-Mod quadratic model fit|Model assumption: 50 % of the maximum effect is achieved at a dose of 3 mg. 90 % of the maximum effect is achieved at a dose of 6 mg.||"A flat vs. non-flat dose-response relationship across the 3 doses of avenciguat and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (Emax, exponential, linear, quadratic, sigmoid emax) while protecting the overall probability of type I error (one-sided alpha of 0.050).~The total daily dose was considered for MCP-Mod analysis (placebo, active avenciguat 3 mg, 6 mg, and 9 mg)."||||0.0102
72340991|NCT04736628|144205909|OTHER|MMRM estimates were used as input for the MCP-Mod. MMRM included the fixed, categorical effects of treatment at each visit (baseline, Week 6, Week 12 and Week 20), and the continuous effect of baseline at each visit (Week 6, Week 12, and Week 20) as well as random effects of patient.||||||0.023|||||||MCP-Mod linear model fit|Model assumption: no assumption is needed.||"A flat vs. non-flat dose-response relationship across the 3 doses of avenciguat and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (Emax, exponential, linear, quadratic, sigmoid emax) while protecting the overall probability of type I error (one-sided alpha of 0.050).~The total daily dose was considered for MCP-Mod analysis (placebo, active avenciguat 3 mg, 6 mg, and 9 mg)."||||0.0230
72340992|NCT04736628|144205909|OTHER|MMRM estimates were used as input for the MCP-Mod. MMRM included the fixed, categorical effects of treatment at each visit (baseline, Week 6, Week 12 and Week 20), and the continuous effect of baseline at each visit (Week 6, Week 12, and Week 20) as well as random effects of patient.||||||0.0292|||||||MCP-Mod Sigmoid Emax model fit|Model assumption: 30 % of the maximum effect is achieved at a dose of 3 mg. 90 % of the maximum effect is achieved at a dose of 6 mg.||"A flat vs. non-flat dose-response relationship across the 3 doses of avenciguat and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (Emax, exponential, linear, quadratic, sigmoid emax) while protecting the overall probability of type I error (one-sided alpha of 0.050).~The total daily dose was considered for MCP-Mod analysis (placebo, active avenciguat 3 mg, 6 mg, and 9 mg)."||||0.0292
72370039|NCT02105961|144250541|SUPERIORITY||Rate ratio (Mepolizumab 100/Placebo)|0.8||||0.034|TWO_SIDED|95.0|0.65|0.98||Unadjusted p-value|Negative binomial model||Analysis using a negative binomial model with covariates of treatment, geographic region, no. of moderate/severe exacerbations in previous year, Baseline percent predicted FEV1, smoking status and offset of log (time in on- and off- treatment period)|||0.98|0.65|0.034
72340993|NCT04736628|144205909|OTHER|MMRM estimates were used as input for the MCP-Mod. MMRM included the fixed, categorical effects of treatment at each visit (baseline, Week 6, Week 12 and Week 20), and the continuous effect of baseline at each visit (Week 6, Week 12, and Week 20) as well as random effects of patient.||||||0.0468|||||||MCP-Mod Exponential model fit|Model assumption: 20% of the maximum effect is achieved at 3 mg.||"A flat vs. non-flat dose-response relationship across the 3 doses of avenciguat and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (Emax, exponential, linear, quadratic, sigmoid emax) while protecting the overall probability of type I error (one-sided alpha of 0.050).~The total daily dose was considered for MCP-Mod analysis (placebo, active avenciguat 3 mg, 6 mg, and 9 mg)."||||0.0468
72340994|NCT04736628|144205910|OTHER||Mean Difference (Net)|-0.217||||0.0327|TWO_SIDED|95.0|-0.416|-0.018|||Mixed-effect Model repeat Measurement||"Least Squares Mean of Avenciguat 1 mg TID - Least Squares Mean of Placebo."|Least Squares Mean differences and 95% confidence intervals were estimated by restricted maximum likelihood (REML)-based mixed-effect model for repeated measures (MMRM) including the fixed, categorical effects of treatment at each visit (baseline, Week 6, Week 12 and Week 20), and the continuous effect of baseline at each visit (Week 6, Week 12, and Week 20) as well as random effects of patient.||-0.018|-0.416|0.0327
72340995|NCT04736628|144205910|OTHER||Mean Difference (Net)|-0.206||||0.0447|TWO_SIDED|95.0|-0.408|-0.005|||Mixed-effect Model repeat Measurement||"Least Squares Mean of Avenciguat 2 mg TID - Least Squares Mean of Placebo."|Least Squares Mean differences and 95% confidence intervals were estimated by restricted maximum likelihood (REML)-based mixed-effect model for repeated measures (MMRM) including the fixed, categorical effects of treatment at each visit (baseline, Week 6, Week 12 and Week 20), and the continuous effect of baseline at each visit (Week 6, Week 12, and Week 20) as well as random effects of patient.||-0.005|-0.408|0.0447
72340996|NCT04736628|144205910|OTHER||Mean Difference (Net)|-0.187||||0.0654|TWO_SIDED|95.0|-0.387|0.012|||Mixed-effect Model repeat Measurement||"Least Squares Mean of Avenciguat 3 mg TID - Least Squares Mean of Placebo."|Least Squares Mean differences and 95% confidence intervals were estimated by restricted maximum likelihood (REML)-based mixed-effect model for repeated measures (MMRM) including the fixed, categorical effects of treatment at each visit (baseline, Week 6, Week 12 and Week 20), and the continuous effect of baseline at each visit (Week 6, Week 12, and Week 20) as well as random effects of patient.||0.012|-0.387|0.0654
72340997|NCT04736628|144205911|OTHER||Odds Ratio (OR)|2.2||||0.0476|TWO_SIDED|95.0|1.01|4.79||Nominal p-value.|Regression, Logistic||Odds ratio (Avenciguat 1 mg TID vs. Placebo).|Treatment and sodium-glucose co-transporter-2 inhibitor (SGLT2i) use at randomization were used as covariates in the logistic regression model.||4.79|1.01|0.0476
72340998|NCT04736628|144205911|OTHER||Odds Ratio (OR)|2.72||||0.0119|TWO_SIDED|95.0|1.25|5.94||Nominal p-value.|Regression, Logistic||Odds ratio (Avenciguat 2 mg TID vs. Placebo).|Treatment and sodium-glucose co-transporter-2 inhibitor (SGLT2i) use at randomization were used as covariates in the logistic regression model.||5.94|1.25|0.0119
72340999|NCT04736628|144205911|OTHER||Odds Ratio (OR)|3.43||||0.0019|TWO_SIDED|95.0|1.58|7.45||Nominal p-value.|Regression, Logistic||Odds ratio (Avenciguat 3 mg TID vs. Placebo).|Treatment and sodium-glucose co-transporter-2 inhibitor (SGLT2i) use at randomization were used as covariates in the logistic regression model.||7.45|1.58|0.0019
72341000|NCT04736628|144205912|OTHER||Odds Ratio (OR)|2.13||||0.0497|TWO_SIDED|95.0|1.0|4.55||Nominal p-value.|Regression, Logistic||Odds ratio (Avenciguat 1 mg TID vs. Placebo).|Treatment and sodium-glucose co-transporter-2 inhibitor (SGLT2i) use at randomization were used as covariates in the logistic regression model.||4.55|1.00|0.0497
72341001|NCT04736628|144205912|OTHER||Odds Ratio (OR)|2.15||||0.0502|TWO_SIDED|95.0|1.0|4.61||Nominal p-value.|Regression, Logistic||Odds ratio (Avenciguat 2 mg TID vs. Placebo).|Treatment and sodium-glucose co-transporter-2 inhibitor (SGLT2i) use at randomization were used as covariates in the logistic regression model.||4.61|1.00|0.0502
72341002|NCT04736628|144205912|OTHER||Odds Ratio (OR)|2.09||||0.0572|TWO_SIDED|95.0|0.98|4.49||Nominal p-value.|Regression, Logistic||Odds ratio (Avenciguat 3 mg TID vs. Placebo).|Treatment and sodium-glucose co-transporter-2 inhibitor (SGLT2i) use at randomization were used as covariates in the logistic regression model.||4.49|0.98|0.0572
72341003|NCT04428151|144205915|SUPERIORITY||Hazard Ratio (HR)|1.48||||0.9963|TWO_SIDED|95.0|1.11|1.97||One-sided p-value based on log-rank test stratified by baseline PD-L1 TPS (\<50% versus ≥50%) and baseline ECOG performance status (0 versus 1). The reported p-value is nominal.|Log Rank||Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by baseline PD-L1 TPS (\<50% versus ≥50%) and baseline ECOG performance status (0 versus 1).|||1.97|1.11|0.9963
72341004|NCT04428151|144205916|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.4181|TWO_SIDED|95.0|0.74|1.28||One-sided p-value based on log-rank test stratified by baseline PD-L1 TPS (\<50% versus ≥50%) and baseline ECOG performance status (0 versus 1). The reported p-value is nominal.|Log Rank||Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by baseline PD-L1 TPS (\<50% versus ≥50%) and baseline ECOG performance status (0 versus 1).|||1.28|0.74|0.4181
72341005|NCT04428151|144205917|SUPERIORITY||Difference in Percentage|-6.5||||0.9266219|TWO_SIDED|95.0|-15.4|2.3|||Miettinen & Nurminen|One-sided p-value for testing H0: difference in % = 0 versus H1: difference in % \> 0. The reported p-value is nominal.|Based on Miettinen \& Nurminen method stratified by baseline PD-L1 TPS (\<50% versus ≥50%) and baseline ECOG performance status (0 versus 1).|||2.3|-15.4|0.9266219
72341006|NCT04068610|144205949|SUPERIORITY||Odds Ratio (OR)|1.8||||0.3173|TWO_SIDED|95.0|0.6|5.6|||Cochran-Mantel-Haenszel|P-value for comparison of treatment arms obtained from stratified Cochran-Mantel-Haenszel test stratified by the location of the primary tumor.||||5.6|0.6|0.3173
72341007|NCT00300677|144205985|SUPERIORITY_OR_OTHER||predose: ratio adjusted geometric means|300.28||||||90.0|192.91|467.43|||ANOVA|Mixed-effects analysis of variance model with time, compartment, and time by compartment interaction as fixed effects and subjects as random effects.|Estimated value = ratio (%) of adjusted geometric means comparing brain (test) vs. plasma (reference) concentrations of voriconazole.|Other estimated parameter represents the Day 3 pre-dose ratio of the adjusted geometric means comparing brain vs. plasma concentrations of voriconazole. Natural-log transformed concentrations of voriconazole were analyzed using a mixed-effects model to obtain the adjusted mean difference (Test-Reference) and 90% confidence interval for the difference which were exponentiated to provide estimates of the ratio of the adjusted geometric means and 90% CI for the ratio.||467.43|192.91|
72341008|NCT00300677|144205985|SUPERIORITY_OR_OTHER||postdose: ratio adjusted geometric means|192.72||||||90.0|123.81|300.0|||ANOVA|Mixed-effects analysis of variance model with time, compartment, and time by compartment interaction as fixed effects and subjects as random effects.|Estimated value = ratio (%) of adjusted geometric means comparing brain (test) vs. plasma (reference) concentrations of voriconazole.|Other estimated parameter represents the Day 3 post-dose ratio of the adjusted geometric means comparing brain vs. plasma concentrations of voriconazole. Natural-log transformed concentrations of voriconazole were analyzed using a mixed-effects model to obtain the adjusted mean difference (Test-Reference) and 90% confidence interval for the difference which were exponentiated to provide estimates of the ratio of the adjusted geometric means and 90% CI for the ratio.||300.00|123.81|
72341009|NCT00300677|144205986|SUPERIORITY_OR_OTHER||predose: ratio adjusted geometric means|300.28||||||90.0|192.91|467.43|||ANOVA|Mixed-effects analysis of variance model with time, compartment, and time by compartment interaction as fixed effects and subjects as random effects.|Estimated value = ratio (%) of the adjusted geometric means comparing brain (test) vs. plasma (reference) concentrations of voriconazole.|Other estimated parameter represents the Day 3 pre-dose ratio of the adjusted geometric means comparing brain vs. plasma concentrations of voriconazole. Natural-log transformed concentrations of voriconazole were analyzed using a mixed-effects model to obtain the adjusted mean difference (Test-Reference) and 90% confidence interval for the difference which were exponentiated to provide estimates of the ratio of the adjusted geometric means and 90% CI for the ratio.||467.43|192.91|
72341010|NCT00300677|144205986|SUPERIORITY_OR_OTHER||postdose: ratio adjusted geometric means|192.72||||||90.0|123.81|300.0|||ANOVA|Mixed-effects analysis of variance model with time, compartment, and time by compartment interaction as fixed effects and subjects as random effects.|Estimated value = ratio (%) of adjusted geometric means comparing brain (test) vs. plasma (reference) concentrations of voriconazole.|Other estimated parameter represents the Day 3 post-dose ratio of the adjusted geometric means comparing brain vs. plasma concentrations of voriconazole. Natural-log transformed concentrations of voriconazole were analyzed using a mixed-effects model to obtain the adjusted mean difference (Test-Reference) and 90% confidence interval for the difference which were exponentiated to provide estimates of the ratio of the adjusted geometric means and 90% CI for the ratio.||300.00|123.81|
72341011|NCT00300677|144205987|SUPERIORITY_OR_OTHER||predose: ratio adjusted geometric means|12.39||||||90.0|7.09|21.65|||ANOVA|Mixed-effects analysis of variance model with time, compartment, and time by compartment interaction as fixed effects and subjects as random effects.|Estimated value = ratio (%) of adjusted geometric means comparing brain (test) vs. plasma (reference) concentrations of voriconazole N-oxide.|Other estimated parameter represents the Day 3 pre-dose ratio of the adjusted geometric means comparing brain vs. plasma concentrations of voriconazole N-oxide. Natural-log transformed concentrations of voriconazole were analyzed using a mixed-effects model to obtain the adjusted mean difference (Test-Reference) and 90% confidence interval for the difference which were exponentiated to provide estimates of the ratio of the adjusted geometric means and 90% CI for the ratio.||21.65|7.09|
72341012|NCT00300677|144205987|SUPERIORITY_OR_OTHER||postdose: ratio adjusted geometric means|31.57||||||90.0|18.06|55.18|||ANOVA|Mixed-effects analysis of variance model with time, compartment, and time by compartment interaction as fixed effects and subjects as random effects.|Estimated value = ratio (%) of adjusted geometric means comparing brain (test) vs. plasma (reference) concentrations of voriconazole N-oxide.|Other estimated parameter represents the Day 3 post-dose ratio of the adjusted geometric means comparing brain vs. plasma concentrations of voriconazole N-oxide. Natural-log transformed concentrations of voriconazole were analyzed using a mixed-effects model to obtain the adjusted mean difference (Test-Reference) and 90% confidence interval for the difference which were exponentiated to provide estimates of the ratio of the adjusted geometric means and 90% CI for the ratio.||55.18|18.06|
72341013|NCT00300677|144205988|SUPERIORITY_OR_OTHER||predose: ratio adjusted mean|12.39||||||90.0|7.09|21.65|||ANOVA|Mixed-effects analysis of variance model with time, compartment, and time by compartment interaction as fixed effects and subjects as random effects.|Estimated value = ratio (%) of adjusted geometric means comparing brain (test) vs. plama (reference) concentrations of voriconazole N-oxide.|Other estimated parameter represents the Day 3 pre-dose ratio of the adjusted geometric means comparing brain vs. plasma concentrations of voriconazole N-oxide. Natural-log transformed concentrations of voriconazole were analyzed using a mixed-effects model to obtain the adjusted mean difference (Test-Reference) and 90% confidence interval for the difference which were exponentiated to provide estimates of the ratio of the adjusted geometric means and 90% CI for the ratio.||21.65|7.09|
72341014|NCT00300677|144205988|SUPERIORITY_OR_OTHER||postdose: ratio adjusted mean|31.57||||||90.0|18.06|55.18|||ANOVA|Mixed-effects analysis of variance model with time, compartment, and time by compartment interaction as fixed effects and subjects as random effects.|Estimated value = ratio (%) of adjusted geometric means comparing brain (test) vs. plasma (reference) concentrations of voriconazole N-oxide.|Other estimated parameter represents the Day 3 post-dose ratio of the adjusted geometric means comparing brain vs. plasma concentrations of voriconazole N-oxide. Natural-log transformed concentrations of voriconazole were analyzed using a mixed-effects model to obtain the adjusted mean difference (Test-Reference) and 90% confidence interval for the difference which were exponentiated to provide estimates of the ratio of the adjusted geometric means and 90% CI for the ratio.||55.18|18.06|
72341015|NCT00443781|144205996|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002||95.0|||||McNemar|Exact test was used.||Mcnemar test was used to test the difference between paired PD (provocative discography) and F.A.D. (Functional Anesthetic Discography) proportions.||||0.002
72341016|NCT02066415|144205997|SUPERIORITY|"A sequential testing procedure, specifically, the hierarchical gate-keeping procedures and Hochberg method, was used to maintain the 2-sided study-wise type I error at 0.05 between the 2 erenumab doses and the primary and secondary endpoints.~This comparison was tested at a 2-sided significance level of 0.04."|Difference in LS Means|-2.46|||<|0.001|TWO_SIDED|95.0|-3.52|-1.39|||Generalized linear mixed model|||The primary endpoint was analyzed using a linear mixed effects model including treatment group, baseline value, stratification factors (region and medication overuse status), scheduled visit, and the interaction of treatment group with scheduled visit.||-1.39|-3.52|<0.001
72428454|NCT01089556|144367817|SUPERIORITY_OR_OTHER|||||||0.571||95.0|||||Fisher Exact|||||||0.571
72428455|NCT01089556|144367818|SUPERIORITY_OR_OTHER|||||||0.744||95.0|||||Fisher Exact|||||||0.744
72428456|NCT01089556|144367819|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|||||||1.000
72341017|NCT02066415|144205997|SUPERIORITY|"A sequential testing procedure, specifically, the hierarchical gate-keeping procedures and Hochberg method, was used to maintain the 2-sided study-wise type I error at 0.05 between the 2 erenumab doses and the primary and secondary endpoints.~This comparison was tested at a 2-sided significance level of 0.01."|Difference in LS Means|-2.45|||<|0.001|TWO_SIDED|95.0|-3.51|-1.38|||Generalized linear mixed model|||The primary endpoint was analyzed using a linear mixed effects model including treatment group, baseline value, stratification factors (region and medication overuse status), scheduled visit, and the interaction of treatment group with scheduled visit.||-1.38|-3.51|<0.001
72341018|NCT02066415|144205998|SUPERIORITY|This comparison was tested at a 2-sided significance level of 0.04.|Odds Ratio (OR)|2.18|||<|0.001|TWO_SIDED|95.0|1.46|3.27|||Cochran-Mantel-Haenszel|||Analyzed using a Cochran-Mantel-Haenszel test after the missing data were imputed as non-response, stratified by stratification factors (region and medication overuse status).||3.27|1.46|<0.001
72341019|NCT02066415|144205998|SUPERIORITY|This comparison was tested at a 2-sided significance level of 0.01.|Odds Ratio (OR)|2.34|||<|0.001|TWO_SIDED|95.0|1.56|3.51|||Cochran-Mantel-Haenszel|||Analyzed using a Cochran-Mantel-Haenszel test after the missing data were imputed as non-response, stratified by stratification factors (region and medication overuse status).||3.51|1.56|<0.001
72341020|NCT02066415|144205999|SUPERIORITY|This comparison was tested at a 2-sided significance level of 0.04.|Difference in LS Means|-1.86|||<|0.001|TWO_SIDED|95.0|-2.6|-1.13|||Generalized linear mixed model|||Analyzed using a linear mixed effects model including treatment group, baseline value, stratification factors (region and medication overuse status), scheduled visit, and the interaction of treatment group with scheduled visit.||-1.13|-2.60|<0.001
72341021|NCT02066415|144205999|SUPERIORITY|This comparison was tested at a 2-sided significance level of 0.01.|Difference in LS Means|-2.55|||<|0.001|TWO_SIDED|95.0|-3.28|-1.82|||Generalized linear mixed model|||Analyzed using a linear mixed effects model including treatment group, baseline value, stratification factors (region and medication overuse status), scheduled visit, and the interaction of treatment group with scheduled visit.||-1.82|-3.28|<0.001
72341022|NCT02066415|144206000|SUPERIORITY|This comparison was tested at a 2-sided significance level of 0.04.|Difference in LS Means|-9.54||||0.28|TWO_SIDED|95.0|-26.98|7.9|||Generalized linear mixed model|||Analyzed using a linear mixed effects model including treatment group, baseline value, stratification factors (region and medication overuse status), scheduled visit, and the interaction of treatment group with scheduled visit.||7.90|-26.98|0.28
72341023|NCT02066415|144206000|SUPERIORITY|This comparison was tested at a 2-sided significance level of 0.01.|Difference in LS Means|-19.31||||0.03|TWO_SIDED|95.0|-36.71|-1.92|||Generalized linear mixed model|||Analyzed using a linear mixed effects model including treatment group, baseline value, stratification factors (region and medication overuse status), scheduled visit, and the interaction of treatment group with scheduled visit.||-1.92|-36.71|0.030
72341024|NCT00576472|144206020|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.033|STANDARD_ERROR_OF_MEAN|0.0062|<|0.0001|TWO_SIDED|95.0|-0.0452|-0.0208|||ANOVA|||||-0.0208|-0.0452|<.0001
72341025|NCT00576472|144206021|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0285|STANDARD_ERROR_OF_MEAN|0.0046|<|0.0001|TWO_SIDED|95.0|0.019|0.038|||ANOVA|||||0.0380|0.0190|<.0001
72341026|NCT00576472|144206022|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0144|STANDARD_ERROR_OF_MEAN|0.0064||0.025|TWO_SIDED|95.0|0.000204|0.0285|||ANOVA|||||0.0285|0.000204|0.025
72341027|NCT00576472|144206022|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0442|STANDARD_ERROR_OF_MEAN|0.0093|<|0.0001|TWO_SIDED|95.0|0.0292|0.0591|||ANOVA|||||0.0591|0.0292|<.0001
72341028|NCT00576472|144206022|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0491|STANDARD_ERROR_OF_MEAN|0.0064|<|0.0001|TWO_SIDED|95.0|0.0396|0.0586|||ANOVA|||||0.0586|0.0396|<.0001
72341029|NCT00576472|144206022|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0298|STANDARD_ERROR_OF_MEAN|0.0083||0.0004|TWO_SIDED|95.0|0.00974|0.0499|||ANOVA|||||0.0499|0.00974|.0004
72341030|NCT00576472|144206022|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0347|STANDARD_ERROR_OF_MEAN|0.0047|<|0.0001|TWO_SIDED|95.0|0.025|0.0445|||ANOVA|||||0.0445|0.0250|<.0001
72341031|NCT00576472|144206022|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.00494|STANDARD_ERROR_OF_MEAN|0.0083||0.552|TWO_SIDED|95.0|-0.00865|0.0185|||ANOVA|||||0.0185|-0.00865|.552
72341032|NCT00576472|144206023|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.17|STANDARD_ERROR_OF_MEAN|1.93||0.0005|TWO_SIDED|95.0|-11.0|-3.3|||ANOVA|||||-3.3|-11.0|.0005
72341033|NCT00576472|144206024|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.34|STANDARD_ERROR_OF_MEAN|1.59||0.0413|TWO_SIDED|95.0|-6.5|-0.1|||ANOVA|||||-0.1|-6.5|0.0413
72341034|NCT00576472|144206025|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.74|STANDARD_ERROR_OF_MEAN|1.2|<|0.0001|TWO_SIDED|95.0|-11.0|-6.4|||ANOVA|||||-6.4|-11.0|<.0001
72341035|NCT00576472|144206026|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.56|STANDARD_ERROR_OF_MEAN|1.3|<|0.0001|TWO_SIDED|95.0|-12.0|-7.0|||ANOVA|||||-7.0|-12.0|<.0001
72341036|NCT00576472|144206027|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.99|STANDARD_ERROR_OF_MEAN|1.81|<|0.0001|TWO_SIDED|95.0|4.4|11.6|||ANOVA|||||11.6|4.4|<.0001
72341037|NCT00576472|144206028|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.21|STANDARD_ERROR_OF_MEAN|1.03||0.8425|TWO_SIDED|95.0|-2.3|1.9|||ANOVA|||||1.9|-2.3|.8425
72341038|NCT00576472|144206029|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.41|STANDARD_ERROR_OF_MEAN|0.73||0.0016|TWO_SIDED|95.0|-3.9|-0.9|||ANOVA|||||-0.9|-3.9|.0016
72341039|NCT00576472|144206030|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.22|STANDARD_ERROR_OF_MEAN|1.04||0.8329|TWO_SIDED|95.0|-1.9|2.3|||ANOVA|||||2.3|-1.9|.8329
72341040|NCT00576472|144206032|SUPERIORITY_OR_OTHER|||||||0.0077||95.0|||||t-test, 2 sided|||||||0.0077
72341041|NCT00576472|144206032|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||||||<0.0001
72341042|NCT00576472|144206032|SUPERIORITY_OR_OTHER|||||||0.1408||95.0|||||t-test, 2 sided|||||||0.1408
72341043|NCT00576472|144206033|SUPERIORITY_OR_OTHER|||||||0.0428||95.0|||||t-test, 2 sided|||||||0.0428
72341044|NCT00576472|144206033|SUPERIORITY_OR_OTHER|||||||0.0058||95.0|||||t-test, 2 sided|||||||0.0058
72341045|NCT00576472|144206033|SUPERIORITY_OR_OTHER|||||||0.4258||95.0|||||t-test, 2 sided|||||||0.4258
72341046|NCT00576472|144206034|SUPERIORITY_OR_OTHER|||||||0.0035||95.0|||||t-test, 2 sided|||||||0.0035
72341047|NCT00576472|144206034|SUPERIORITY_OR_OTHER|||||||0.0003||95.0|||||t-test, 2 sided|||||||0.0003
72341048|NCT00576472|144206034|SUPERIORITY_OR_OTHER|||||||0.4086||95.0|||||t-test, 2 sided|||||||0.4086
72341049|NCT00576472|144206035|SUPERIORITY_OR_OTHER|||||||0.0001||95.0|||||t-test, 2 sided|||||||0.0001
72341050|NCT00576472|144206035|SUPERIORITY_OR_OTHER|||||||0.0007||95.0|||||t-test, 2 sided|||||||0.0007
72341051|NCT00576472|144206035|SUPERIORITY_OR_OTHER|||||||0.7007||95.0|||||t-test, 2 sided|||||||0.7007
72341052|NCT00576472|144206036|SUPERIORITY_OR_OTHER|||||||0.0002||95.0|||||t-test, 2 sided|||||||0.0002
72341053|NCT00576472|144206036|SUPERIORITY_OR_OTHER|||||||0.0016||95.0|||||t-test, 2 sided|||||||0.0016
72341054|NCT00576472|144206036|SUPERIORITY_OR_OTHER|||||||0.6237||95.0|||||t-test, 2 sided|||||||0.6237
72341055|NCT00576472|144206037|SUPERIORITY_OR_OTHER|||||||0.0002||95.0|||||t-test, 2 sided|||||||0.0002
72341056|NCT00576472|144206037|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||||||<.0001
72341057|NCT00576472|144206037|SUPERIORITY_OR_OTHER|||||||0.6071||95.0|||||t-test, 2 sided|||||||0.6071
72341058|NCT00576472|144206038|SUPERIORITY_OR_OTHER|||||||0.1386||95.0|||||t-test, 2 sided|||||||0.1386
72341059|NCT00576472|144206038|SUPERIORITY_OR_OTHER|||||||0.0905||95.0|||||t-test, 2 sided|||||||0.0905
72341060|NCT00576472|144206038|SUPERIORITY_OR_OTHER|||||||0.8039||95.0|||||t-test, 2 sided|||||||0.8039
72341061|NCT00576472|144206039|SUPERIORITY_OR_OTHER|||||||0.7496||95.0|||||t-test, 2 sided|||||||0.7496
72341062|NCT00576472|144206039|SUPERIORITY_OR_OTHER|||||||0.9489||95.0|||||t-test, 2 sided|||||||0.9489
72341063|NCT00576472|144206039|SUPERIORITY_OR_OTHER|||||||0.7021||95.0|||||t-test, 2 sided|||||||0.7021
72341064|NCT00576472|144206040|SUPERIORITY_OR_OTHER|||||||0.019||95.0|||||t-test, 2 sided|||||||0.0190
72341065|NCT00576472|144206040|SUPERIORITY_OR_OTHER|||||||0.0003||95.0|||||t-test, 2 sided|||||||0.0003
72341066|NCT00576472|144206040|SUPERIORITY_OR_OTHER|||||||0.1622||95.0|||||t-test, 2 sided|||||||0.1622
72341067|NCT00576472|144206041|SUPERIORITY_OR_OTHER|||||||0.1202||95.0|||||t-test, 2 sided|||||||0.1202
72341068|NCT00576472|144206041|SUPERIORITY_OR_OTHER|||||||0.0103||95.0|||||t-test, 2 sided|||||||0.0103
72341069|NCT00576472|144206041|SUPERIORITY_OR_OTHER|||||||0.2831||95.0|||||t-test, 2 sided|||||||0.2831
72341070|NCT00576472|144206042|SUPERIORITY_OR_OTHER|||||||0.7027||95.0|||||t-test, 2 sided|||||||0.7027
72341071|NCT00576472|144206043|SUPERIORITY_OR_OTHER|||||||0.7493||95.0|||||t-test, 2 sided|||||||0.7493
72341072|NCT00576472|144206044|SUPERIORITY_OR_OTHER|||||||0.7339||95.0|||||t-test, 2 sided|||||||0.7339
72341073|NCT00576472|144206045|SUPERIORITY_OR_OTHER|||||||0.6148||95.0|||||t-test, 2 sided|||||||0.6148
72341074|NCT00576472|144206046|SUPERIORITY_OR_OTHER|||||||0.4456||95.0|||||t-test, 2 sided|||||||0.4456
72341075|NCT00576472|144206047|SUPERIORITY_OR_OTHER|||||||0.5866||95.0|||||t-test, 2 sided|||||||0.5866
72341076|NCT00576472|144206048|SUPERIORITY_OR_OTHER|||||||0.8918||95.0|||||t-test, 2 sided|||||||0.8918
72341077|NCT00576472|144206049|SUPERIORITY_OR_OTHER|||||||0.4427||95.0|||||t-test, 2 sided|||||||0.4427
72341078|NCT00576472|144206050|SUPERIORITY_OR_OTHER|||||||0.4203||95.0|||||t-test, 2 sided|||||||0.4203
72341079|NCT00576472|144206051|SUPERIORITY_OR_OTHER|||||||0.5754||95.0|||||t-test, 2 sided|||||||0.5754
72341080|NCT00576472|144206052|SUPERIORITY_OR_OTHER|||||||0.0251||95.0|||||t-test, 2 sided|||||||0.0251
72341081|NCT00576472|144206053|SUPERIORITY_OR_OTHER|||||||0.1049||95.0|||||t-test, 2 sided|||||||0.1049
72341082|NCT00574548|144206058|NON_INFERIORITY_OR_EQUIVALENCE|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean ratio greater than 0.5 (2-fold criterion).|ratio of geometric mean titer|1.0|||||TWO_SIDED|95.0|0.75|1.33|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (\[13vPnC / 23vPS\] - \[23vPS\]).|Serotype 1: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.||1.33|0.75|
72341083|NCT00574548|144206058|NON_INFERIORITY_OR_EQUIVALENCE|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean ratio greater than 0.5 (2-fold criterion).|ratio of geometric mean titer|1.6|||||TWO_SIDED|95.0|1.24|1.94|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (\[13vPnC / 23vPS\] - \[23vPS\]).|Serotype 3: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.||1.94|1.24|
72341084|NCT00574548|144206058|NON_INFERIORITY_OR_EQUIVALENCE|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean ratio greater than 0.5 (2-fold criterion).|ratio of geometric mean titer|1.0|||||TWO_SIDED|95.0|0.74|1.41|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (\[13vPnC / 23vPS\] - \[23vPS\]).|Serotype 4: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.||1.41|0.74|
72341085|NCT00574548|144206058|NON_INFERIORITY_OR_EQUIVALENCE|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean ratio greater than 0.5 (2-fold criterion).|ratio of geometric mean titer|1.4|||||TWO_SIDED|95.0|1.01|2.0|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (\[13vPnC / 23vPS\] - \[23vPS\]).|Serotype 5: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.||2.00|1.01|
72341086|NCT00574548|144206058|NON_INFERIORITY_OR_EQUIVALENCE|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean ratio greater than 0.5 (2-fold criterion).|ratio of geometric mean titer|1.7|||||TWO_SIDED|95.0|1.18|2.51|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (\[13vPnC / 23vPS\] - \[23vPS\]).|Serotype 6B: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.||2.51|1.18|
72428457|NCT01950273|144367853|NON_INFERIORITY_OR_EQUIVALENCE|Standard equivalence limit 80% to 125%.|Least Squares (LS) mean ratio|89.53|||||TWO_SIDED|90.0|75.42|106.29|||||Ratio of the adjusted geometric means calculated as (LS mean ratio of BI 695500/Rituximab (MabThera®)).|||106.29|75.42|
72428458|NCT01950273|144367854|NON_INFERIORITY_OR_EQUIVALENCE|Standard equivalence limit 80% to 125%.|Least Squares (LS) means ratio|94.6||||||90.0|85.04|105.23|||||Ratio of the adjusted geometric means calculated as (LS mean ratio of BI 695500/Rituximab (MabThera®)).|||105.23|85.04|
72341087|NCT00574548|144206058|NON_INFERIORITY_OR_EQUIVALENCE|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean ratio greater than 0.5 (2-fold criterion).|ratio of geometric mean titer|1.6|||||TWO_SIDED|95.0|1.07|2.47|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (\[13vPnC / 23vPS\] - \[23vPS\]).|Serotype 7F: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.||2.47|1.07|
72341088|NCT00574548|144206058|NON_INFERIORITY_OR_EQUIVALENCE|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean ratio greater than 0.5 (2-fold criterion).|ratio of geometric mean titer|1.3|||||TWO_SIDED|95.0|0.79|2.12|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (\[13vPnC / 23vPS\] - \[23vPS\]).|Serotype 9V: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.||2.12|0.79|
72341089|NCT00574548|144206058|NON_INFERIORITY_OR_EQUIVALENCE|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean ratio greater than 0.5 (2-fold criterion).|ratio of geometric mean titer|0.8|||||TWO_SIDED|95.0|0.58|1.25|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (\[13vPnC / 23vPS\] - \[23vPS\]).|Serotype 14: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.||1.25|0.58|
72341090|NCT00574548|144206058|NON_INFERIORITY_OR_EQUIVALENCE|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean ratio greater than 0.5 (2-fold criterion).|ratio of geometric mean titer|1.3|||||TWO_SIDED|95.0|0.94|1.93|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (\[13vPnC / 23vPS\] - \[23vPS\]).|Serotype 18C: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.||1.93|0.94|
72341091|NCT00574548|144206058|NON_INFERIORITY_OR_EQUIVALENCE|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean ratio greater than 0.5 (2-fold criterion).|ratio of geometric mean titer|1.2|||||TWO_SIDED|95.0|0.96|1.61|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (\[13vPnC / 23vPS\] - \[23vPS\]).|Serotype 19A: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.||1.61|0.96|
72341092|NCT00574548|144206058|NON_INFERIORITY_OR_EQUIVALENCE|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean ratio greater than 0.5 (2-fold criterion).|ratio of geometric mean titer|1.5|||||TWO_SIDED|95.0|1.09|2.12|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (\[13vPnC / 23vPS\] - \[23vPS\]).|Serotype 19F: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.||2.12|1.09|
72341093|NCT00574548|144206058|NON_INFERIORITY_OR_EQUIVALENCE|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean ratio greater than 0.5 (2-fold criterion).|ratio of geometric mean titer|2.8|||||TWO_SIDED|95.0|1.86|4.35|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (\[13vPnC / 23vPS\] - \[23vPS\]).|Serotype 23F: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.||4.35|1.86|
72341094|NCT00574548|144206059|NON_INFERIORITY_OR_EQUIVALENCE|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean ratio greater than 0.5 (2-fold criterion).|ratio of geometric mean titer|1.9|||||TWO_SIDED|95.0|1.43|2.57|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (\[13vPnC / 23vPS\] - \[23vPS / 13vPnC\]).|Serotype 1: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.||2.57|1.43|
72341095|NCT00574548|144206059|NON_INFERIORITY_OR_EQUIVALENCE|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean ratio greater than 0.5 (2-fold criterion).|ratio of geometric mean titer|2.5|||||TWO_SIDED|95.0|1.95|3.16|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (\[13vPnC / 23vPS\] - \[23vPS / 13vPnC\]).|Serotype 3: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.||3.16|1.95|
72341096|NCT00574548|144206059|NON_INFERIORITY_OR_EQUIVALENCE|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean ratio greater than 0.5 (2-fold criterion).|ratio of geometric mean titer|1.5|||||TWO_SIDED|95.0|1.12|1.96|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (\[13vPnC / 23vPS\] - \[23vPS / 13vPnC\]).|Serotype 4: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.||1.96|1.12|
72341097|NCT00574548|144206059|NON_INFERIORITY_OR_EQUIVALENCE|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean ratio greater than 0.5 (2-fold criterion).|ratio of geometric mean titer|2.4|||||TWO_SIDED|95.0|1.67|3.31|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (\[13vPnC / 23vPS\] - \[23vPS / 13vPnC\]).|Serotype 5: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.||3.31|1.67|
72428459|NCT01950273|144367855|NON_INFERIORITY_OR_EQUIVALENCE|Standard equivalence limit 80% to 125%.|Least Squares (LS) means ratio|89.94|||||TWO_SIDED|90.0|77.62|104.23|||||Ratio of the adjusted geometric means calculated as (LS mean ratio of BI 695500/Rituximab (MabThera®)).|||104.23|77.62|
72341098|NCT00574548|144206059|NON_INFERIORITY_OR_EQUIVALENCE|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean ratio greater than 0.5 (2-fold criterion).|ratio of geometric mean titer|1.7|||||TWO_SIDED|95.0|1.19|2.47|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (\[13vPnC / 23vPS\] - \[23vPS / 13vPnC\]).|Serotype 6B: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.||2.47|1.19|
72341099|NCT00574548|144206059|NON_INFERIORITY_OR_EQUIVALENCE|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean ratio greater than 0.5 (2-fold criterion).|ratio of geometric mean titer|4.3|||||TWO_SIDED|95.0|2.76|6.61|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (\[13vPnC / 23vPS\] - \[23vPS / 13vPnC\]).|Serotype 7F: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.||6.61|2.76|
72341100|NCT00574548|144206059|NON_INFERIORITY_OR_EQUIVALENCE|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean ratio greater than 0.5 (2-fold criterion).|ratio of geometric mean titer|3.3|||||TWO_SIDED|95.0|1.97|5.45|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (\[13vPnC / 23vPS\] - \[23vPS / 13vPnC\]).|Serotype 9V: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.||5.45|1.97|
72341101|NCT00574548|144206059|NON_INFERIORITY_OR_EQUIVALENCE|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean ratio greater than 0.5 (2-fold criterion).|ratio of geometric mean titer|1.4|||||TWO_SIDED|95.0|0.98|2.1|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (\[13vPnC / 23vPS\] - \[23vPS / 13vPnC\]).|Serotype 14: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.||2.10|0.98|
72341102|NCT00574548|144206059|NON_INFERIORITY_OR_EQUIVALENCE|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean ratio greater than 0.5 (2-fold criterion).|ratio of geometric mean titer|1.9|||||TWO_SIDED|95.0|1.32|2.69|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (\[13vPnC / 23vPS\] - \[23vPS / 13vPnC\]).|Serotype 18C: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.||2.69|1.32|
72341103|NCT00574548|144206059|NON_INFERIORITY_OR_EQUIVALENCE|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean ratio greater than 0.5 (2-fold criterion).|ratio of geometric mean titer|1.6|||||TWO_SIDED|95.0|1.27|2.07|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (\[13vPnC / 23vPS\] - \[23vPS / 13vPnC\]).|Serotype 19A: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.||2.07|1.27|
72341104|NCT00574548|144206059|NON_INFERIORITY_OR_EQUIVALENCE|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean ratio greater than 0.5 (2-fold criterion).|ratio of geometric mean titer|2.7|||||TWO_SIDED|95.0|1.96|3.74|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (\[13vPnC / 23vPS\] - \[23vPS / 13vPnC\]).|Serotype 19F: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.||3.74|1.96|
72341105|NCT00574548|144206059|NON_INFERIORITY_OR_EQUIVALENCE|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean ratio greater than 0.5 (2-fold criterion).|ratio of geometric mean titer|1.6|||||TWO_SIDED|95.0|1.05|2.45|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (\[13vPnC / 23vPS\] - \[23vPS / 13vPnC\]).|Serotype 23F: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.||2.45|1.05|
72341106|NCT00574548|144206060|NON_INFERIORITY_OR_EQUIVALENCE|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean fold rise greater than 0.5.|Geometric mean fold rise|0.7|||||TWO_SIDED|95.0|0.54|0.82|||||CIs are back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise.|Serotype 1: geometric mean fold rise (GMFR) calculated using all evaluable participants with data from both the postvaccination 1 and postvaccination 2 blood draws.||0.82|0.54|
72341107|NCT00574548|144206060|NON_INFERIORITY_OR_EQUIVALENCE|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean fold rise greater than 0.5.|Geometric mean fold rise|1.2|||||TWO_SIDED|95.0|0.99|1.49|||||CIs are back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise.|Serotype 3: geometric mean fold rise (GMFR) calculated using all evaluable participants with data from both the postvaccination 1 and postvaccination 2 blood draws.||1.49|0.99|
72341108|NCT00574548|144206060|NON_INFERIORITY_OR_EQUIVALENCE|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean fold rise greater than 0.5.|Geometric mean fold rise|0.5|||||TWO_SIDED|95.0|0.43|0.68|||||CIs are back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise.|Serotype 4: geometric mean fold rise (GMFR) calculated using all evaluable participants with data from both the postvaccination 1 and postvaccination 2 blood draws.||0.68|0.43|
72428460|NCT01950273|144367856|NON_INFERIORITY_OR_EQUIVALENCE|Standard equivalence limit 80% to 125%.|Least Squares (LS) means ratio|97.65|||||TWO_SIDED|90.0|90.45|105.42|||||Ratio of the adjusted geometric means calculated as (LS mean ratio of BI 695500/Rituximab (MabThera®)).|||105.42|90.45|
72341109|NCT00574548|144206060|NON_INFERIORITY_OR_EQUIVALENCE|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean fold rise greater than 0.5.|Geometric mean fold rise|0.6|||||TWO_SIDED|95.0|0.43|0.77|||||CIs are back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise.|Serotype 5: geometric mean fold rise (GMFR) calculated using all evaluable participants with data from both the postvaccination 1 and postvaccination 2 blood draws.||0.77|0.43|
72341110|NCT00574548|144206060|NON_INFERIORITY_OR_EQUIVALENCE|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean fold rise greater than 0.5.|Geometric mean fold rise|0.9|||||TWO_SIDED|95.0|0.67|1.08|||||CIs are back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise.|Serotype 6A: geometric mean fold rise (GMFR) calculated using all evaluable participants with data from both the postvaccination 1 and postvaccination 2 blood draws.||1.08|0.67|
72341111|NCT00574548|144206060|NON_INFERIORITY_OR_EQUIVALENCE|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean fold rise greater than 0.5.|Geometric mean fold rise|0.9|||||TWO_SIDED|95.0|0.71|1.12|||||CIs are back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise.|Serotype 6B: geometric mean fold rise (GMFR) calculated using all evaluable participants with data from both the postvaccination 1 and postvaccination 2 blood draws.||1.12|0.71|
72341112|NCT00574548|144206060|NON_INFERIORITY_OR_EQUIVALENCE|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean fold rise greater than 0.5.|Geometric mean fold rise|0.3|||||TWO_SIDED|95.0|0.24|0.49|||||CIs are back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise.|Serotype 7F: geometric mean fold rise (GMFR) calculated using all evaluable participants with data from both the postvaccination 1 and postvaccination 2 blood draws.||0.49|0.24|
72341113|NCT00574548|144206060|NON_INFERIORITY_OR_EQUIVALENCE|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean fold rise greater than 0.5.|Geometric mean fold rise|0.4|||||TWO_SIDED|95.0|0.26|0.51|||||CIs are back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise.|Serotype 9V: geometric mean fold rise (GMFR) calculated using all evaluable participants with data from both the postvaccination 1 and postvaccination 2 blood draws.||0.51|0.26|
72341114|NCT00574548|144206060|NON_INFERIORITY_OR_EQUIVALENCE|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean fold rise greater than 0.5.|Geometric mean fold rise|0.8|||||TWO_SIDED|95.0|0.6|1.02|||||CIs are back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise.|Serotype 14: geometric mean fold rise (GMFR) calculated using all evaluable participants with data from both the postvaccination 1 and postvaccination 2 blood draws.||1.02|0.60|
72341115|NCT00574548|144206060|NON_INFERIORITY_OR_EQUIVALENCE|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean fold rise greater than 0.5.|Geometric mean fold rise|0.7|||||TWO_SIDED|95.0|0.54|0.87|||||CIs are back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise.|Serotype 18C: geometric mean fold rise (GMFR) calculated using all evaluable participants with data from both the postvaccination 1 and postvaccination 2 blood draws.||0.87|0.54|
72341116|NCT00574548|144206060|NON_INFERIORITY_OR_EQUIVALENCE|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean fold rise greater than 0.5.|Geometric mean fold rise|0.7|||||TWO_SIDED|95.0|0.53|0.82|||||CIs are back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise.|Serotype 19A: geometric mean fold rise (GMFR) calculated using all evaluable participants with data from both the postvaccination 1 and postvaccination 2 blood draws.||0.82|0.53|
72341117|NCT00574548|144206060|NON_INFERIORITY_OR_EQUIVALENCE|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean fold rise greater than 0.5.|Geometric mean fold rise|0.9|||||TWO_SIDED|95.0|0.69|1.15|||||CIs are back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise.|Serotype 19F: geometric mean fold rise (GMFR) calculated using all evaluable participants with data from both the postvaccination 1 and postvaccination 2 blood draws.||1.15|0.69|
72341118|NCT00574548|144206060|NON_INFERIORITY_OR_EQUIVALENCE|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean fold rise greater than 0.5.|Geometric mean fold rise|1.6|||||TWO_SIDED|95.0|1.15|2.13|||||CIs are back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise.|Serotype 23F: geometric mean fold rise (GMFR) calculated using all evaluable participants with data from both the postvaccination 1 and postvaccination 2 blood draws.||2.13|1.15|
72341119|NCT00574548|144206061|NON_INFERIORITY_OR_EQUIVALENCE|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean fold rise greater than 0.5.|Geometric mean fold rise|0.6|||||TWO_SIDED|95.0|0.55|0.75|||||CIs are back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise.|Serotype 1: geometric mean fold rise (GMFR) calculated using all evaluable participants with data from both the postvaccination 1 and postvaccination 2 blood draws.||0.75|0.55|
72341120|NCT00574548|144206061|NON_INFERIORITY_OR_EQUIVALENCE|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean fold rise greater than 0.5.|Geometric mean fold rise|1.7|||||TWO_SIDED|95.0|1.52|2.01|||||CIs are back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise.|Serotype 3: geometric mean fold rise (GMFR) calculated using all evaluable participants with data from both the postvaccination 1 and postvaccination 2 blood draws.||2.01|1.52|
72341121|NCT00574548|144206061|NON_INFERIORITY_OR_EQUIVALENCE|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean fold rise greater than 0.5.|Geometric mean fold rise|0.6|||||TWO_SIDED|95.0|0.49|0.66|||||CIs are back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise.|Serotype 4: geometric mean fold rise (GMFR) calculated using all evaluable participants with data from both the postvaccination 1 and postvaccination 2 blood draws.||0.66|0.49|
72428461|NCT01950273|144367857|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|249.2|||||TWO_SIDED|90.0|-210.6|709.0|||||Mean difference calculated as BI 695500-Rituximab (MabThera®).|||709|-210.6|
72341122|NCT00574548|144206061|NON_INFERIORITY_OR_EQUIVALENCE|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean fold rise greater than 0.5.|Geometric mean fold rise|0.8|||||TWO_SIDED|95.0|0.67|1.03|||||CIs are back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise.|Serotype 5: geometric mean fold rise (GMFR) calculated using all evaluable participants with data from both the postvaccination 1 and postvaccination 2 blood draws.||1.03|0.67|
72341123|NCT00574548|144206061|NON_INFERIORITY_OR_EQUIVALENCE|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean fold rise greater than 0.5.|Geometric mean fold rise|0.7|||||TWO_SIDED|95.0|0.57|0.79|||||CIs are back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise.|Serotype 6B: geometric mean fold rise (GMFR) calculated using all evaluable participants with data from both the postvaccination 1 and postvaccination 2 blood draws.||0.79|0.57|
72341124|NCT00574548|144206061|NON_INFERIORITY_OR_EQUIVALENCE|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean fold rise greater than 0.5.|Geometric mean fold rise|0.4|||||TWO_SIDED|95.0|0.35|0.52|||||CIs are back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise.|Serotype 7F: geometric mean fold rise (GMFR) calculated using all evaluable participants with data from both the postvaccination 1 and postvaccination 2 blood draws.||0.52|0.35|
72341125|NCT00574548|144206061|NON_INFERIORITY_OR_EQUIVALENCE|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean fold rise greater than 0.5.|Geometric mean fold rise|0.5|||||TWO_SIDED|95.0|0.41|0.69|||||CIs are back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise.|Serotype 9V: geometric mean fold rise (GMFR) calculated using all evaluable participants with data from both the postvaccination 1 and postvaccination 2 blood draws.||0.69|0.41|
72341126|NCT00574548|144206061|NON_INFERIORITY_OR_EQUIVALENCE|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean fold rise greater than 0.5.|Geometric mean fold rise|0.9|||||TWO_SIDED|95.0|0.75|1.15|||||CIs are back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise.|Serotype 14: geometric mean fold rise (GMFR) calculated using all evaluable participants with data from both the postvaccination 1 and postvaccination 2 blood draws.||1.15|0.75|
72341127|NCT00574548|144206061|NON_INFERIORITY_OR_EQUIVALENCE|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean fold rise greater than 0.5.|Geometric mean fold rise|0.7|||||TWO_SIDED|95.0|0.58|0.85|||||CIs are back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise.|Serotype 18C: geometric mean fold rise (GMFR) calculated using all evaluable participants with data from both the postvaccination 1 and postvaccination 2 blood draws.||0.85|0.58|
72341128|NCT00574548|144206061|NON_INFERIORITY_OR_EQUIVALENCE|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean fold rise greater than 0.5.|Geometric mean fold rise|0.7|||||TWO_SIDED|95.0|0.58|0.74|||||CIs are back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise.|Serotype 19A: geometric mean fold rise (GMFR) calculated using all evaluable participants with data from both the postvaccination 1 and postvaccination 2 blood draws.||0.74|0.58|
72341129|NCT00574548|144206061|NON_INFERIORITY_OR_EQUIVALENCE|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean fold rise greater than 0.5.|Geometric mean fold rise|1.1|||||TWO_SIDED|95.0|0.89|1.39|||||CIs are back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise.|Serotype 19F: geometric mean fold rise (GMFR) calculated using all evaluable participants with data from both the postvaccination 1 and postvaccination 2 blood draws.||1.39|0.89|
72341130|NCT00574548|144206061|NON_INFERIORITY_OR_EQUIVALENCE|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean fold rise greater than 0.5.|Geometric mean fold rise|0.6|||||TWO_SIDED|95.0|0.5|0.73|||||CIs are back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise.|Serotype 23F: geometric mean fold rise (GMFR) calculated using all evaluable participants with data from both the postvaccination 1 and postvaccination 2 blood draws.||0.73|0.50|
72341131|NCT00574548|144206062|SUPERIORITY_OR_OTHER||ratio of geometric mean titer|2.7|||||TWO_SIDED|95.0|2.03|3.55|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (\[13vPnC\] - \[23vPS / 13vPnC\]).|Serotype 1: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.||3.55|2.03|
72341132|NCT00574548|144206062|SUPERIORITY_OR_OTHER||ratio of geometric mean titer|1.5|||||TWO_SIDED|95.0|1.18|1.89|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (\[13vPnC\] - \[23vPS / 13vPnC\]).|Serotype 3: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.||1.89|1.18|
72341133|NCT00574548|144206062|SUPERIORITY_OR_OTHER||ratio of geometric mean titer|2.7|||||TWO_SIDED|95.0|2.07|3.55|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (\[13vPnC\] - \[23vPS / 13vPnC\]).|Serotype 4: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.||3.55|2.07|
72341134|NCT00574548|144206062|SUPERIORITY_OR_OTHER||ratio of geometric mean titer|2.5|||||TWO_SIDED|95.0|1.77|3.61|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (\[13vPnC\] - \[23vPS / 13vPnC\]).|Serotype 5: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.||3.61|1.77|
72341135|NCT00574548|144206062|SUPERIORITY_OR_OTHER||ratio of geometric mean titer|2.7|||||TWO_SIDED|95.0|1.94|3.88|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (\[13vPnC\] - \[23vPS / 13vPnC\]).|Serotype 6B: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.||3.88|1.94|
72428462|NCT01950273|144367859|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.4|||||TWO_SIDED|95.0|-29.4|11.1|||||Difference in ORR calculated as ORR (BI695500) - ORR (MabThera®). The confidence interval represented is 95% difference in proportions.|||11.1|-29.4|
72341136|NCT00574548|144206062|SUPERIORITY_OR_OTHER||ratio of geometric mean titer|8.5|||||TWO_SIDED|95.0|5.68|12.6|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (\[13vPnC\] - \[23vPS / 13vPnC\]).|Serotype 7F: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.||12.60|5.68|
72341137|NCT00574548|144206062|SUPERIORITY_OR_OTHER||ratio of geometric mean titer|6.7|||||TWO_SIDED|95.0|4.45|10.22|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (\[13vPnC\] - \[23vPS / 13vPnC\]).|Serotype 9V: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.||10.22|4.45|
72341138|NCT00574548|144206062|SUPERIORITY_OR_OTHER||ratio of geometric mean titer|1.5|||||TWO_SIDED|95.0|1.02|2.18|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (\[13vPnC\] - \[23vPS / 13vPnC\]).|Serotype 14: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.||2.18|1.02|
72341139|NCT00574548|144206062|SUPERIORITY_OR_OTHER||ratio of geometric mean titer|2.8|||||TWO_SIDED|95.0|2.01|3.89|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (\[13vPnC\] - \[23vPS / 13vPnC\]).|Serotype 18C: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.||3.89|2.01|
72341140|NCT00574548|144206062|SUPERIORITY_OR_OTHER||ratio of geometric mean titer|2.5|||||TWO_SIDED|95.0|1.92|3.13|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (\[13vPnC\] - \[23vPS / 13vPnC\]).|Serotype 19A: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.||3.13|1.92|
72341141|NCT00574548|144206062|SUPERIORITY_OR_OTHER||ratio of geometric mean titer|2.5|||||TWO_SIDED|95.0|1.8|3.44|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (\[13vPnC\] - \[23vPS / 13vPnC\]).|Serotype 19F: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.||3.44|1.80|
72341142|NCT00574548|144206062|SUPERIORITY_OR_OTHER||ratio of geometric mean titer|2.9|||||TWO_SIDED|95.0|1.92|4.28|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (\[13vPnC\] - \[23vPS / 13vPnC\]).|Serotype 23F: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.||4.28|1.92|
72341143|NCT04971941|144206088|SUPERIORITY||Mean Difference (Final Values)|1.7|STANDARD_DEVIATION|2.17||0.001|TWO_SIDED|95.0|0.4|2.1||This P value applies to comparison of IAN with and without DentalVibe|t-test, 2 sided|df =58||Sample size estimation from Nanitsos 2010: Using the P value from the paired T test with 61 degrees of freedom the T statistic calculated at 4.365. From mean difference 9.3 SD was calculated as 16.66 for an effect size of 0.558. This generated a sample size of 44 subjects, receiving 2 injections (1 with DV3 and 1 without), is necessary to attain 95% power for a paired t-test comparing the 2 pain measures at a two-tailed alpha level of 0.05. P value for IAN||2.1|0.4|0.001
72341144|NCT04971941|144206088|SUPERIORITY||Mean Difference (Final Values)|-1.6|STANDARD_DEVIATION|1.75||0.02|TWO_SIDED|95.0|-1.7|-1.5|||t-test, 2 sided|df= 58||||-1.5|-1.7|0.02
72341145|NCT04971941|144206088|SUPERIORITY||Mean Difference (Net)|1.2|STANDARD_DEVIATION|1.74||0.004|TWO_SIDED|95.0|0.4|2.1|||t-test, 2 sided|||||2.1|0.4|0.004
72341146|NCT04971941|144206089|SUPERIORITY||Mean Difference (Net)|4.0||||0.001|TWO_SIDED|14.0|0.4|4.8||This P value applies to comparing IAN with or with DV as measured by SSI tolerability/ability to endure|t-test, 2 sided|||||4.8|0.4|0.001
72341147|NCT04971941|144206089|SUPERIORITY|||||||0.003|||||||t-test, 2 sided|||||||0.003
72341148|NCT04971941|144206089|SUPERIORITY|||||||0.003|||||||t-test, 2 sided|||||||0.003
72341149|NCT04971941|144206089|SUPERIORITY|||||||0.058|||||||t-test, 2 sided|||||||0.058
72341150|NCT04971941|144206089|SUPERIORITY|||||||0.008|||||||t-test, 2 sided|||||||0.008
72341151|NCT04971941|144206089|SUPERIORITY|||||||0.044|||||||t-test, 2 sided|||||||0.044
72341152|NCT04971941|144206089|SUPERIORITY|||||||0.023|||||||t-test, 2 sided|||||||0.023
72341153|NCT04971941|144206089|SUPERIORITY|||||||0.042|||||||t-test, 2 sided|||||||0.042
72341154|NCT04971941|144206089|SUPERIORITY|||||||0.053|||||||t-test, 2 sided|||||||0.053
72341155|NCT04971941|144206090|SUPERIORITY|||||||0.459|||||||t-test, 2 sided|||The null hypothesis is that there is no relation between use of DV and numb times. There were no studies from which to perform a power calculation for this outcome measure||||0.459
72341156|NCT01325714|144206091|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were based on the ability to detect a small-to-moderate difference (Cohen's h = .4) between treatment groups in rate of aggression onset over a 1-year period, assuming 80% power and T1 error rate of 5%. This differential rate in aggression onset is comparable to a 37% rate of aggression onset over a 1 year period for the control group versus 19% for the treatment group. Given this, our goal was to include 220 total participants (after 10% attrition: N = 198).|Hazard Ratio (HR)|0.71||||0.13|TWO_SIDED|95.0|0.45|1.11||This is the p value from the discrete-time Cox regression time-to-event analyses|Regression, Cox|DF = 1|The enhanced usual care arm is the comparison group.|"Univariate time-to-event analyses, using discrete-time Cox regression models to evaluate differences between PAVeD and EU-PC in the primary outcome of incidence of aggression over time.~We expected that patients with dementia among dyads randomized to PAVeD arm would be less likely to develop aggression compared to those randomized to the enhanced usual care arm."||1.11|0.45|0.13
72428463|NCT01950273|144367860|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|2.0|||||TWO_SIDED|95.0|-18.0|22.1|||||Difference in TEAE incidence calculated as BI695500 - TEAE incidence (MabThera®). The confidence interval represented is 95% difference in proportions.|||22.1|-18.0|
72341157|NCT01325714|144206091|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were based on the ability to detect a small-to-moderate difference (Cohen's h = .4) between treatment groups in rate of aggression onset over a 1-year period, assuming 80% power and T1 error rate of 5%. This differential rate in aggression onset is comparable to a 37% rate of aggression onset over a 1 year period for the control group versus 19% for the treatment group. Given this, our goal was to include 220 total participants (after 10% attrition: N = 198).|Hazard Ratio (HR)|0.77||||0.39|TWO_SIDED|95.0|0.43|1.39||From discrete time-cox regression time-to-event analysis.|Regression, Cox|df = 1|The enhanced usual care arm is the reference group.|Comparison of incidence of non-verbal aggression between treatment groups.||1.39|0.43|0.39
72341158|NCT01325714|144206091|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were based on the ability to detect a small-to-moderate difference (Cohen's h = .4) between treatment groups in rate of aggression onset (the primary outcome) over a 1-year period, assuming 80% power and type I error rate of 5%. This differential rate in aggression onset is comparable to a 37% rate of aggression onset over a 1 year period for the control group (anticipated based on estimated rates from prior work) versus 19% for the treatment group|Hazard Ratio (HR)|0.84||||0.84|TWO_SIDED|95.0|0.51|1.37||From discrete-time Cox regression time-to-event analyses|Regression, Cox|df = 1|The usual care arm is the reference group.|Examination of group differences in incidence of verbal aggression. We expected those in paved to have lower incidence of verbal aggression relative to those in enhanced usual care.||1.37|0.51|0.84
72341159|NCT01325714|144206092|SUPERIORITY_OR_OTHER||Results of F value of growth curve model|0.86||||0.46|TWO_SIDED|||||P value of the interaction between treatment group and time (time coded as 0, 3, 6, 12).|Mixed Models Analysis|F (3, 455) = 0.86||Growth curve models were conducted to examine whether there were differences between treatment groups in change in caregiver reported worst pain over time.||||0.46
72341160|NCT01325714|144206093|SUPERIORITY_OR_OTHER||Results of F value of growth curve model|1.43||||0.23|TWO_SIDED|||||P value of the interaction between treatment group and time (time coded as 0, 3, 6, 12).|Mixed Models Analysis|||Growth curve models were conducted to examine whether there were differences between treatment groups in change in caregiver reported worst pain over time.||||0.23
72341161|NCT01325714|144206094|SUPERIORITY_OR_OTHER||Results of F value of growth curve model|1.45||||0.23|TWO_SIDED|||||P value of the interaction between treatment group and time (time coded as 0, 3, 6, 12).|Mixed Models Analysis|F (3, 455) = 1.45||Growth curve models were conducted to examine whether there were differences between treatment groups in change in caregiver reported overall pain over time.||||0.23
72341162|NCT01325714|144206095|SUPERIORITY_OR_OTHER||Results of F value of growth curve model|0.86||||0.62|TWO_SIDED|||||P value of the interaction between treatment group and time (time coded as 0, 3, 6, 12).|Mixed Models Analysis|F (3, 409) = 0.59||Growth curve models were conducted to examine whether there were differences between treatment groups in change in patient-reported overall pain over time.||||0.62
72341163|NCT01325714|144206096|SUPERIORITY_OR_OTHER||Results of F value of growth curve model|0.94||||0.42|TWO_SIDED|||||P value of the interaction between treatment group and time (time coded as 0, 3, 6, 12).|Mixed Models Analysis|F (3, 453) = 0.94.||Growth curve models were conducted to examine whether there were differences between treatment groups in change in depression over time.||||0.42
72341164|NCT01325714|144206097|SUPERIORITY_OR_OTHER||Results of F value of growth curve model|1.1||||0.35|TWO_SIDED|||||P value of the interaction between treatment group and time (time coded as 0, 3, 6, 12).|Mixed Models Analysis|F (3, 457) = 1.10||Growth curve models were conducted to examine whether there were differences between treatment groups in change in pleasant events over time.||||0.35
72341165|NCT01325714|144206098|SUPERIORITY_OR_OTHER||Results of F value of growth curve model|0.11||||0.11|TWO_SIDED|||||P value of the interaction between treatment group and time (time coded as 0, 3, 6, 12).|Mixed Models Analysis|F (3, 456) = 2.00||Growth curve models were conducted to examine whether there were differences between treatment groups in change in caregiver burden over time.||||0.11
72341166|NCT01325714|144206099|SUPERIORITY_OR_OTHER||Results of F value of growth curve model|3.84||||0.01|TWO_SIDED|||||P value of the interaction between treatment group and time (time coded as 0, 3, 6, 12).|Mixed Models Analysis|F (3, 456) = 3.84||Growth curve models were conducted to examine whether there were differences between treatment groups in change in caregiver reported mutuality over time.||||0.01
72341167|NCT00721175|144206100|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2407407|STANDARD_ERROR_OF_MEAN|0.0920078||0.011|TWO_SIDED|95.0|-0.4210726|-0.0604089|||Two-sample test of proportion|||||-.0604089|-.4210726|0.011
72341168|NCT00721175|144206101|SUPERIORITY_OR_OTHER|||||||0.0021||95.0|||||Log Rank|||||||0.0021
72341169|NCT00721175|144206103|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.278744|STANDARD_ERROR_OF_MEAN|0.0929622||0.004|TWO_SIDED|95.0|-0.4609466|-0.0965414|||Two-sample test of proportion|||||-.0965414|-.4609466|0.004
72341170|NCT01561963|144206129|EQUIVALENCE|No statistically significant interaction between apremilast and rifampicin was confirmed if both the upper and lower 90% confidence interval (CI) limits for the geometric least squares mean ratios of apremilast administered with rifampicin to apremilast alone fell within the no effect boundary of 80% to 125%.|Ratio of Geometric Least Squares Means|96.35|||||TWO_SIDED|90.0|88.56|104.82|||||Apremilast + IV Rifampin / Apremilast Alone|The effect of rifampicin on the PK of apremilast was evaluated using a linear mixed effect analysis of variance on the log-transformed values of AUCt of apremilast, to estimate the mean ratio of apremilast administered with and without rifampicin treatment. The model included treatment as fixed effect, and subject as a random effect.||104.82|88.56|
72341171|NCT01561963|144206129|EQUIVALENCE|No statistically significant interaction between apremilast and rifampicin was confirmed if both the upper and lower 90% CI limits for the geometric least squares mean ratios of apremilast administered with rifampicin to apremilast alone fell within the no effect boundary of 80% to 125%.|Ratio of Geometric Least Squares Means|27.88|||||TWO_SIDED|90.0|25.63|30.34|||||Apremilast + Multiple Dose Oral Rifampin / Apremilast Alone|The effect of rifampicin on the PK of apremilast was evaluated using a linear mixed effect analysis of variance on the log-transformed values of AUCt of apremilast, to estimate the mean ratio of apremilast administered with and without rifampicin treatment. The model included treatment as fixed effect, and subject as a random effect.||30.34|25.63|
72428464|NCT00432679|144367889|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.81|STANDARD_ERROR_OF_MEAN|0.102|<|0.001|TWO_SIDED|95.0|-1.01|-0.61||Change from Baseline in HbA1c = Treatment+ Baseline HbA1c+ Gender+ body mass index (BMI)|ANCOVA|||||-0.61|-1.01|<0.001
72341172|NCT01561963|144206130|EQUIVALENCE|No statistically significant interaction between apremilast and rifampicin was confirmed if both the upper and lower 90% CI limits for the geometric least squares mean ratios of apremilast administered with rifampicin to apremilast alone fell within the no effect boundary of 80% to 125%.|Ratio of Geometric Least Squares Means|95.71|||||TWO_SIDED|90.0|87.99|104.12|||||Apremilast + IV Rifampin / Apremilast Alone|The effect of rifampicin on the PK of apremilast was evaluated using a linear mixed effect analysis of variance on the log-transformed values of AUC∞ of apremilast, to estimate the mean ratio of apremilast administered with and without rifampicin treatment. The model included treatment as fixed effect, and subject as a random effect.||104.12|87.99|
72341173|NCT01561963|144206130|EQUIVALENCE|No statistically significant interaction between apremilast and rifampicin was confirmed if both the upper and lower 90% CI limits for the geometric least squares mean ratios of apremilast administered with rifampicin to apremilast alone fell within the no effect boundary of 80% to 125%.|Ratio of Geometric Least Squares Means|27.96|||||TWO_SIDED|90.0|25.7|30.41|||||Apremilast + Multiple Dose Oral Rifampin / Apremilast Alone|The effect of rifampicin on the PK of apremilast was evaluated using a linear mixed effect analysis of variance on the log-transformed values of AUC∞ of apremilast, to estimate the mean ratio of apremilast administered with and without rifampicin treatment. The model included treatment as fixed effect, and subject as a random effect.||30.41|25.70|
72341174|NCT01561963|144206131|EQUIVALENCE|No statistically significant interaction between apremilast and rifampicin was confirmed if both the upper and lower 90% CI limits for the geometric least squares mean ratios of apremilast administered with rifampicin to apremilast alone fell within the no effect boundary of 80% to 125%.|Ratio of Geometric Least Squares Means|113.07|||||TWO_SIDED|90.0|103.18|123.91|||||Apremilast + IV Rifampin / Apremilast Alone|The effect of rifampicin on the PK of apremilast was evaluated using a linear mixed effect analysis of variance on the log-transformed values of Cmax of apremilast, to estimate the mean ratio of apremilast administered with and without rifampicin treatment. The model included treatment as fixed effect, and subject as a random effect.||123.91|103.18|
72341175|NCT01561963|144206131|EQUIVALENCE|No statistically significant interaction between apremilast and rifampicin was confirmed if both the upper and lower 90% CI limits for the geometric least squares mean ratios of apremilast administered with rifampicin to apremilast alone fell within the no effect boundary of 80% to 125%.|Ratio of Geometric Least Squares Means|56.8|||||TWO_SIDED|90.0|51.84|62.25|||||Apremilast + Multiple Dose Oral Rifampin / Apremilast Alone|The effect of rifampicin on the PK of apremilast was evaluated using a linear mixed effect analysis of variance on the log-transformed values of Cmax of apremilast, to estimate the mean ratio of apremilast administered with and without rifampicin treatment. The model included treatment as fixed effect, and subject as a random effect.||62.25|51.84|
72341176|NCT01561963|144206132|OTHER||Median Difference|-0.25||||0.2656|TWO_SIDED|90.0|-0.75|0.0|||Wilcoxon signed rank test||Apremilast + IV Rifampin - Apremilast Alone|Tmax was analyzed using nonparametric methods. The median difference and 90% CI of the median difference were calculated from the Hodges-Lehrmann estimate.||0.00|-0.75|0.2656
72341177|NCT01561963|144206132|OTHER||Median Difference|-0.5||||0.1141|TWO_SIDED|90.0|-1.0|0.0|||Wilcoxon signed rank test||Apremilast + Multiple Dose Oral Rifampin - Apremilast Alone|Tmax was analyzed using nonparametric methods. The median difference and 90% CI of the median difference were calculated from the Hodges-Lehrmann estimate.||0.00|-1.00|0.1141
72341178|NCT02299076|144206142|SUPERIORITY|Welch Two Sample t-test|||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
72341179|NCT00162266|144206144|SUPERIORITY_OR_OTHER||Point Estimate of Difference|25.6|||<|0.001|TWO_SIDED|95.0|12.8|38.4|||Chi-squared|||||38.4|12.8|<0.001
72341180|NCT00162266|144206144|SUPERIORITY_OR_OTHER||Point Estimate of Difference|6.6||||0.31|TWO_SIDED|95.0|-6.2|19.4|||Chi-squared|||||19.4|-6.2|0.31
72341181|NCT00162266|144206145|SUPERIORITY_OR_OTHER||Point Estimate of Difference|5.9||||0.283|TWO_SIDED|95.0|-4.9|16.7|||Chi-squared|||Response on Day 15||16.7|-4.9|0.283
72341182|NCT00162266|144206145|SUPERIORITY_OR_OTHER||Point Estimate of Difference|-11.6||||0.015|TWO_SIDED|95.0|-20.9|-2.3|||Chi-squared|||Response on Day 15||-2.3|-20.9|0.015
72341183|NCT00162266|144206145|SUPERIORITY_OR_OTHER||Point Estimate of Difference|11.5||||0.067|TWO_SIDED|95.0|-0.8|23.8|||Chi-squared|||Response on Day 30||23.8|-0.8|0.067
72341184|NCT00162266|144206145|SUPERIORITY_OR_OTHER||Point Estimate of Difference|-9.3||||0.113|TWO_SIDED|95.0|-20.8|2.2|||Chi-squared|||Response on Day 30||2.2|-20.8|0.113
72341185|NCT00162266|144206145|SUPERIORITY_OR_OTHER||Point Estimate of Difference|22.1|||<|0.001|TWO_SIDED|95.0|9.3|34.8|||Chi-squared|||Response on Day 60||34.8|9.3|<0.001
72341186|NCT00162266|144206145|SUPERIORITY_OR_OTHER||Point Estimate of Difference|-1.1||||0.86|TWO_SIDED|95.0|-13.5|11.3|||Chi-squared|||Response on Day 60||11.3|-13.5|0.86
72341187|NCT00162266|144206145|SUPERIORITY_OR_OTHER||Point Estimate of Difference|18.6||||0.004|TWO_SIDED|95.0|5.9|31.4|||Chi-squared|||Response on Day 90||31.4|5.9|0.004
72341188|NCT00162266|144206145|SUPERIORITY_OR_OTHER||Point Estimate of Difference|2.8||||0.664|TWO_SIDED|95.0|-9.8|15.4|||Chi-squared|||Response on Day 90||15.4|-9.8|0.664
72341189|NCT00162266|144206145|SUPERIORITY_OR_OTHER||Point Estimate of Difference|23.9|||<|0.001|TWO_SIDED|95.0|11.1|36.7|||Chi-squared|||Response on Day 120||36.7|11.1|<0.001
72341190|NCT00162266|144206145|SUPERIORITY_OR_OTHER||Point Estimate of Difference|6.9||||0.292|TWO_SIDED|95.0|-6.0|19.9|||Chi-squared|||Response on Day 120||19.9|-6.0|0.292
72341191|NCT00162266|144206145|SUPERIORITY_OR_OTHER||Point Estimate of Difference|23.0|||<|0.001|TWO_SIDED|95.0|10.2|35.8|||Chi-squared|||Response on Day 150||35.8|10.2|<0.001
72341192|NCT00162266|144206145|SUPERIORITY_OR_OTHER||Point Estimate of Difference|8.5||||0.193|TWO_SIDED|95.0|-4.3|21.3|||Chi-squared|||Response on Day 150||21.3|-4.3|0.193
72341193|NCT00162266|144206145|SUPERIORITY_OR_OTHER||Point Estimate of Difference|25.6|||<|0.001|TWO_SIDED|95.0|12.8|38.4|||Chi-squared|||Response on Day 180||38.4|12.8|<0.001
72341194|NCT00162266|144206145|SUPERIORITY_OR_OTHER||Point Estimate of Difference|6.6||||0.31||95.0|-6.2|19.4|||Chi-squared|||Response on Day 180||19.4|-6.2|0.31
72341195|NCT00162266|144206145|SUPERIORITY_OR_OTHER||Point Estimate of Difference|27.3|||<|0.001|TWO_SIDED|95.0|14.5|40.1|||Chi-squared|||Response on Day 240||40.1|14.5|<0.001
72341196|NCT00162266|144206145|SUPERIORITY_OR_OTHER||Point Estimate of Difference|5.7||||0.384|TWO_SIDED|95.0|-7.1|18.4|||Chi-squared|||Response on Day 240||18.4|-7.1|0.384
72341197|NCT00162266|144206145|SUPERIORITY_OR_OTHER||Point Estimate of Difference|29.0|||<|0.001|TWO_SIDED|95.0|16.2|41.8|||Chi-squared|||Response on Day 300||41.8|16.2|<0.001
72341198|NCT00162266|144206145|SUPERIORITY_OR_OTHER||Point Estimate of Difference|4.6||||0.476|TWO_SIDED|95.0|-8.0|17.2|||Chi-squared|||Response on Day 300||17.2|-8.0|0.476
72341199|NCT00162266|144206145|SUPERIORITY_OR_OTHER||Point Estimate of Difference|26.5|||<|0.001|TWO_SIDED|95.0|13.7|39.3|||Chi-squared|||Response on Day 360||39.3|13.7|<0.001
72341200|NCT00162266|144206145|SUPERIORITY_OR_OTHER||Point Estimate of Difference|5.8||||0.377|TWO_SIDED|95.0|-7.0|18.6|||Chi-squared|||Response on Day 360||18.6|-7.0|0.377
72341201|NCT00162266|144206146|SUPERIORITY_OR_OTHER||Point Estimate of Difference|-0.8||||0.679|TWO_SIDED|95.0|-4.5|2.9|||Chi-squared|||Response on Day 15||2.9|-4.5|0.679
72341202|NCT00162266|144206146|SUPERIORITY_OR_OTHER||Point Estimate of Difference|-2.5||||0.101|TWO_SIDED|95.0|-5.5|0.5|||Chi-squared|||Response on Day 15||0.5|-5.5|0.101
72341203|NCT00162266|144206146|SUPERIORITY_OR_OTHER||Point Estimate of Difference|8.0||||0.039|TWO_SIDED|95.0|0.4|15.7|||Chi-squared|||Response on Day 30||15.7|0.4|0.039
72341204|NCT00162266|144206146|SUPERIORITY_OR_OTHER||Point Estimate of Difference|-2.1||||0.474|TWO_SIDED|95.0|-7.7|3.6|||Chi-squared|||Response on Day 30||3.6|-7.7|0.474
72341205|NCT00162266|144206146|SUPERIORITY_OR_OTHER||Point Estimate of Difference|6.6||||0.192|TWO_SIDED|95.0|-3.3|16.5|||Chi-squared|||Response on Day 60||16.5|-3.3|0.192
72341206|NCT00162266|144206146|SUPERIORITY_OR_OTHER||Point Estimate of Difference|-1.8||||0.702|TWO_SIDED|95.0|-11.0|7.4|||Chi-squared|||Response on Day 60||7.4|-11.0|0.702
72341207|NCT00162266|144206146|SUPERIORITY_OR_OTHER||Point Estimate of Difference|11.7||||0.02|TWO_SIDED|95.0|1.8|21.7|||Chi-squared|||Response on Day 90||21.7|1.8|0.02
72341208|NCT00162266|144206146|SUPERIORITY_OR_OTHER||Point Estimate of Difference|4.5||||0.339|TWO_SIDED|95.0|-4.8|13.8|||Chi-squared|||Response on Day 90||13.8|-4.8|0.339
72341209|NCT00162266|144206146|SUPERIORITY_OR_OTHER||Point Estimate of Difference|17.9||||0.001|TWO_SIDED|95.0|7.0|28.9|||Chi-squared|||Response on Day 120||28.9|7.0|0.001
72341210|NCT00162266|144206146|SUPERIORITY_OR_OTHER||Point Estimate of Difference|2.0||||0.682|TWO_SIDED|95.0|-7.6|11.7|||Chi-squared|||Response on Day 120||11.7|-7.6|0.682
72341211|NCT00162266|144206146|SUPERIORITY_OR_OTHER||Point Estimate of Difference|20.6|||<|0.001|TWO_SIDED|95.0|9.3|31.8|||Chi-squared|||Response on Day 150||31.8|9.3|<0.001
72341212|NCT00162266|144206146|SUPERIORITY_OR_OTHER||Point Estimate of Difference|1.2||||0.813|TWO_SIDED|95.0|-8.6|10.9|||Chi-squared|||Response on Day 150||10.9|-8.6|0.813
72341213|NCT00162266|144206146|SUPERIORITY_OR_OTHER||Point Estimate of Difference|24.8|||<|0.001|TWO_SIDED|95.0|13.8|35.7|||Chi-squared|||Response on Day 180||35.7|13.8|<0.001
72341214|NCT00162266|144206146|SUPERIORITY_OR_OTHER||Point Estimate of Difference|11.1||||0.027|TWO_SIDED|95.0|1.2|20.9|||Chi-squared|||Response on Day 180||20.9|1.2|0.027
72341215|NCT00162266|144206146|SUPERIORITY_OR_OTHER||Point Estimate of Difference|15.5||||0.008|TWO_SIDED|95.0|4.0|27.0|||Chi-squared|||Response on Day 240||27.0|4.0|0.008
72341216|NCT00162266|144206146|SUPERIORITY_OR_OTHER||Point Estimate of Difference|0.8||||0.885|TWO_SIDED|95.0|-9.8|11.4|||Chi-squared|||Response on Day 240||11.4|-9.8|0.885
72341217|NCT00162266|144206146|SUPERIORITY_OR_OTHER||Point Estimate of Difference|24.0|||<|0.001|TWO_SIDED|95.0|12.6|35.4|||Chi-squared|||Response on Day 300||35.4|12.6|<0.001
72341218|NCT00162266|144206146|SUPERIORITY_OR_OTHER||Point Estimate of Difference|6.8||||0.19|TWO_SIDED|95.0|-3.4|16.9|||Chi-squared|||Response on Day 300||16.9|-3.4|0.19
72341219|NCT00162266|144206146|SUPERIORITY_OR_OTHER||Point Estimate of Difference|21.6|||<|0.001|TWO_SIDED|95.0|9.7|33.4|||Chi-squared|||Response on Day 360||33.4|9.7|<0.001
72341220|NCT00162266|144206146|SUPERIORITY_OR_OTHER||Point Estimate of Difference|2.7||||0.625|TWO_SIDED|95.0|-8.1|13.5|||Chi-squared|||Response on Day 360||13.5|-8.1|0.625
72341221|NCT00162266|144206147|SUPERIORITY_OR_OTHER||Point Estimate of Difference|3.5||||0.04||95.0|0.2|6.8|||Chi-squared|||Response on Day 30||6.8|0.2|0.04
72341222|NCT00162266|144206147|SUPERIORITY_OR_OTHER||Point Estimate of Difference|2.9||||0.063|TWO_SIDED|95.0|-0.2|5.9|||Chi-squared|||Response on Day 30||5.9|-0.2|0.063
72341223|NCT00162266|144206147|SUPERIORITY_OR_OTHER||Point Estimate of Difference|8.7||||0.001|TWO_SIDED|95.0|3.5|13.9|||Chi-squared|||Response on Day 60||13.9|3.5|0.001
72341224|NCT00162266|144206147|SUPERIORITY_OR_OTHER||Point Estimate of Difference|3.8||||0.032|TWO_SIDED|95.0|0.3|7.3|||Chi-squared|||Response on Day 60||7.3|0.3|0.032
72341225|NCT00162266|144206147|SUPERIORITY_OR_OTHER||Point Estimate of Difference|7.9||||0.005|TWO_SIDED|95.0|2.4|13.3|||Chi-squared|||Response on Day 90||13.3|2.4|0.005
72341226|NCT00162266|144206147|SUPERIORITY_OR_OTHER||Point Estimate of Difference|3.9||||0.07|TWO_SIDED|95.0|-0.3|8.2|||Chi-squared|||Response on Day 90||8.2|-0.3|0.07
72341227|NCT00162266|144206147|SUPERIORITY_OR_OTHER||Point Estimate of Difference|9.7||||0.007|TWO_SIDED|95.0|2.7|16.7|||Chi-squared|||Response on Day 120||16.7|2.7|0.007
72341228|NCT00162266|144206147|SUPERIORITY_OR_OTHER||Point Estimate of Difference|2.4||||0.395||95.0|-3.1|7.8|||Chi-squared|||||7.8|-3.1|0.395
72341229|NCT00162266|144206147|SUPERIORITY_OR_OTHER||Point Estimate of Difference|10.6||||0.004|TWO_SIDED|95.0|3.4|17.7|||Chi-squared|||Response on Day 150||17.7|3.4|0.004
72341230|NCT00162266|144206147|SUPERIORITY_OR_OTHER||Point Estimate of Difference|2.4||||0.395|TWO_SIDED|95.0|-3.1|7.8|||Chi-squared|||Response on Day 150||7.8|-3.1|0.395
72341231|NCT00162266|144206147|SUPERIORITY_OR_OTHER||Point Estimate of Difference|14.8|||<|0.001|TWO_SIDED|95.0|7.5|22.2|||Chi-squared|||Response on Day 180||22.2|7.5|<0.001
72341232|NCT00162266|144206147|SUPERIORITY_OR_OTHER||Point Estimate of Difference|8.8||||0.005|TWO_SIDED|95.0|2.7|14.9|||Chi-squared|||Response on Day 180||14.9|2.7|0.005
72341233|NCT00162266|144206147|SUPERIORITY_OR_OTHER||Point Estimate of Difference|13.2||||0.002|TWO_SIDED|95.0|5.0|21.4|||Chi-squared|||Response on Day 240||21.4|5.0|0.002
72341234|NCT00162266|144206147|SUPERIORITY_OR_OTHER||Point Estimate of Difference|3.5||||0.292|TWO_SIDED|95.0|-3.0|10.1|||Chi-squared|||Response on Day 240||10.1|-3.0|0.292
72341235|NCT00162266|144206147|SUPERIORITY_OR_OTHER||Point Estimate of Difference|21.0|||<|0.001|TWO_SIDED|95.0|12.4|29.5|||Chi-squared|||Response on Day 300||29.5|12.4|<0.001
72341236|NCT00162266|144206147|SUPERIORITY_OR_OTHER||Point Estimate of Difference|8.0||||0.014|TWO_SIDED|95.0|1.6|14.3|||Chi-squared|||Response on Day 300||14.3|1.6|0.014
72341237|NCT00162266|144206147|SUPERIORITY_OR_OTHER||Point Estimate of Difference|13.3||||0.003|TWO_SIDED|95.0|4.4|22.2|||Chi-squared|||Response on Day 360||22.2|4.4|0.003
72341238|NCT00162266|144206147|SUPERIORITY_OR_OTHER||Point Estimate of Difference|4.8||||0.227|TWO_SIDED|95.0|-3.0|12.6|||Chi-squared|||Response on Day 360||12.6|-3.0|0.227
72341239|NCT00162266|144206148|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.02||||0.2676|TWO_SIDED|95.0|-1.56|5.61|||ANOVA|ANOVA model: AUC = treatment|Estimate= Model AUC for abatacept+methotrexate - Model AUC for placebo+methotrexate|Day 15 Treatment Comparison||5.61|-1.56|0.2676
72341240|NCT00162266|144206148|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.8||||0.0418|TWO_SIDED|95.0|-7.46|-0.14|||ANOVA|ANOVA model: AUC = treatment|Estimate= Model AUC for abatacept+methotrexate - Model AUC for placebo+methotrexate|Day 15 Treatment Comparison||-0.14|-7.46|0.0418
72341241|NCT00162266|144206148|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.25||||0.0061|TWO_SIDED|95.0|2.08|12.41|||ANOVA|ANOVA model: AUC = treatment|Estimate= Model AUC for abatacept+methotrexate - Model AUC for placebo+methotrexate|Day 30 Treatment Comparison||12.41|2.08|0.0061
72341242|NCT00162266|144206148|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.14||||0.6713|TWO_SIDED|95.0|-6.45|4.16||ANOVA model: AUC = treatment|ANOVA||Estimate= Model AUC for abatacept+methotrexate - Model AUC for placebo+methotrexate|Day 30 Treatment Comparison||4.16|-6.45|0.6713
72341243|NCT00162266|144206148|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.75||||0.0002|TWO_SIDED|95.0|5.67|17.84|||ANOVA|ANOVA model: AUC = treatment|Estimate= Model AUC for abatacept+methotrexate - Model AUC for placebo+methotrexate|Day 60 Treatment Comparison||17.84|5.67|0.0002
72341244|NCT00162266|144206148|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.6||||0.8495|TWO_SIDED|95.0|-5.62|6.82|||ANOVA|ANOVA model: AUC = treatment|Estimate= Model AUC for abatacept+methotrexate - Model AUC for placebo+methotrexate|Day 60 Treatment Comparison||6.82|-5.62|0.8495
72341245|NCT00162266|144206148|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.1||||0.0003|TWO_SIDED|95.0|5.63|18.56|||ANOVA|ANOVA model: AUC = treatment|Estimate= Model AUC for abatacept+methotrexate - Model AUC for placebo+methotrexate|Day 90 Treatment Comparison||18.56|5.63|0.0003
72341246|NCT00162266|144206148|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.19||||0.0003|TWO_SIDED|95.0|-2.44|10.81|||ANOVA|ANOVA model: AUC = treatment|Estimate= Model AUC for abatacept+methotrexate - Model AUC for placebo+methotrexate|Day 90 Treatment Comparison||10.81|-2.44|0.0003
72341247|NCT00162266|144206148|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.54||||0.0001|TWO_SIDED|95.0|7.28|21.81|||ANOVA|ANOVA model: AUC = treatment|Estimate= Model AUC for abatacept+methotrexate - Model AUC for placebo+methotrexate|Day 120 Treatment Comparison||21.81|7.28|0.0001
72341248|NCT00162266|144206148|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.6||||0.3141|TWO_SIDED|95.0|-3.43|10.64|||ANOVA|ANOVA model: AUC = treatment|Estimate= Model AUC for abatacept+methotrexate - Model AUC for placebo+methotrexate|Day 120 Treatment Comparison||10.64|-3.43|0.3141
72341249|NCT00162266|144206148|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.96||||0.0001|TWO_SIDED|95.0|8.49|25.43|||ANOVA|ANOVA model: AUC = treatment|Estimate= Model AUC for abatacept+methotrexate - Model AUC for placebo+methotrexate|Day 150 Treatment Comparison||25.43|8.49|0.0001
72341250|NCT00162266|144206148|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.32||||0.3552|TWO_SIDED|95.0|-3.73|10.37|||ANOVA|ANOVA model: AUC = treatment|Estimate= Model AUC for abatacept+methotrexate - Model AUC for placebo+methotrexate|Day 150 Treatment Comparison||10.37|-3.73|0.3552
72341251|NCT00162266|144206148|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|20.36||||0.0001|TWO_SIDED|95.0|10.19|30.54|||ANOVA|ANOVA model: AUC = treatment|Estimate= Model AUC for abatacept+methotrexate - Model AUC for placebo+methotrexate|Day 180 Treatment Comparison||30.54|10.19|0.0001
72341252|NCT00162266|144206148|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.38||||0.0451|TWO_SIDED|95.0|0.16|14.6|||ANOVA|ANOVA model: AUC = treatment|Estimate= Model AUC for abatacept+methotrexate - Model AUC for placebo+methotrexate|Day 180 Treatment Comparison||14.60|0.16|0.0451
72341253|NCT00162266|144206148|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|17.63||||0.0001|TWO_SIDED|95.0|8.83|26.44|||ANOVA|ANOVA model: AUC = treatment|Estimate= Model AUC for abatacept+methotrexate - Model AUC for placebo+methotrexate|Day 240 Treatment Comparison||26.44|8.83|0.0001
72341254|NCT00162266|144206148|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.78||||0.4669|TWO_SIDED|95.0|-4.73|10.28|||ANOVA|ANOVA model: AUC = treatment|Estimate= Model AUC for abatacept+methotrexate - Model AUC for placebo+methotrexate|Day 240 Treatment Comparison||10.28|-4.73|0.4669
72341255|NCT00162266|144206148|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|21.0||||0.0001|TWO_SIDED|95.0|10.51|31.48|||ANOVA|ANOVA model: AUC = treatment|Estimate= Model AUC for abatacept+methotrexate - Model AUC for placebo+methotrexate|Day 300 Treatment Comparison||31.48|10.51|0.0001
72341256|NCT00162266|144206148|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.13||||3.13|TWO_SIDED|95.0|-4.15|10.41|||ANOVA|ANOVA model: AUC = treatment|Estimate= Model AUC for abatacept+methotrexate - Model AUC for placebo+methotrexate|Day 300 Treatment Comparison||10.41|-4.15|3.13
72341257|NCT00162266|144206148|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|20.38||||0.0001|TWO_SIDED|95.0|10.2|30.56|||ANOVA|ANOVA model: AUC = treatment|Estimate= Model AUC for abatacept+methotrexate - Model AUC for placebo+methotrexate|Day 360 Treatment Comparison||30.56|10.20|0.0001
72341258|NCT00162266|144206148|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.06||||0.2989|TWO_SIDED|95.0|-3.61|11.72|||ANOVA|ANOVA model: AUC = treatment|Estimate= Model AUC for abatacept+methotrexate - Model AUC for placebo+methotrexate|Day 360 Treatment Comparison||11.72|-3.61|0.2989
72341259|NCT00162266|144206149|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2132.63||||0.0001|TWO_SIDED|95.0|1067.32|3197.94||ANOVA model: AUC = treatment|ANOVA||Estimate = Model AUC for Aripiprazole+MTX - Model AUC for PLACEBO+MTX|Comparison at Day 180||3197.94|1067.32|0.0001
72341260|NCT00162266|144206149|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|353.47||||0.4393|TWO_SIDED|95.0|-544.46|1251.41||ANOVA model: AUC = treatment|ANOVA||Estimate = Model AUC for Aripiprazole+MTX - Model AUC for PLACEBO+MTX|Comparison at Day 180||1251.41|-544.46|0.4393
72341261|NCT00162266|144206149|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5641.6||||0.0001|TWO_SIDED|95.0|2823.46|8459.74||ANOVA model: AUC = treatment|ANOVA||Estimate = Model AUC for Aripiprazole+MTX - Model AUC for PLACEBO+MTX|Comparison at Day 360||8459.74|2823.46|0.0001
72341262|NCT00162266|144206149|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1054.38||||0.3029|TWO_SIDED|95.0|-955.59|3064.35||ANOVA model: AUC = treatment|ANOVA||Estimate = Model AUC for Aripiprazole+MTX - Model AUC for PLACEBO+MTX|Comparison at Day 360||3064.35|-955.59|0.3029
72428465|NCT00432679|144367890|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-22.1|STANDARD_ERROR_OF_MEAN|5.06|<|0.001|TWO_SIDED|95.0|-32.1|-12.1|||Unpaired t-test|||||-12.1|-32.1|<0.001
72341263|NCT00162266|144206153|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|27.66||||0.0003|TWO_SIDED|95.0|12.67|42.66|||ANCOVA|ANCOVA: % change = pretreatment|Estimate = adjusted % change (BMS10mg/kg+MTX or BMS 2mg/kg+MTX) - adjusted change for placebo+MTX|Day 180||42.66|12.67|0.0003
72341264|NCT00162266|144206153|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.68||||0.3253|TWO_SIDED|95.0|||||ANCOVA|ANCOVA model: % change = pretreatment|Estimate = adjusted % change (BMS10mg/kg+MTX or BMS 2mg/kg+MTX) - adjusted change for placebo+MTX|Day 180||||0.3253
72341265|NCT00162266|144206153|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|32.24||||0.0001|TWO_SIDED|95.0|16.14|48.33|||ANCOVA|ANCOVA model: % change = pretreatment|Estimate = adjusted % change (BMS10mg/kg+MTX or BMS 2mg/kg+MTX) - adjusted change for placebo+MTX|Day 360||48.33|16.14|0.0001
72341266|NCT00162266|144206153|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.48||||0.0869|TWO_SIDED|95.0|-1.82|26.78|||ANCOVA|ANCOVA model: % change = pretreatment|Estimate = adjusted % change (BMS10mg/kg+MTX or BMS 2mg/kg+MTX) - adjusted change for placebo+MTX|Day 360||26.78|-1.82|0.0869
72341267|NCT02117349|144206216|OTHER||Odds Ratio (OR)|42.8|||=|0.001|TWO_SIDED|95.0|4.58|401.0||Study was terminated early at 55 randomized subjects, therefore p-value is considered nominal|Regression, Logistic|||Odds Ratio (OR) and Wald-based 95% Confidence intervals (CIs) are from logistic regression model comparing the response between treatment arms.||401.0|4.58|= 0.0010
72341268|NCT02265796|144206241|SUPERIORITY||||||>|0.05||||||the reported p value is for all between group comparisons of the SAQ domains.|t-test, 2 sided|||between group comparison for all SAQ domains||||>0.05
72341269|NCT02265796|144206241|SUPERIORITY||||||>|0.05||||||reported p value is for the physical limitation, angina frequency and treatment satisfaction domains|paired t test|||within group comparison of change from baseline||||>0.05
72341270|NCT02265796|144206241|SUPERIORITY||||||<|0.05||||||reported p value is for the angina stability and quality of life domains|paired t test|||within group comparison of change from baseline||||<0.05
72341271|NCT02265796|144206241|SUPERIORITY||||||>|0.05||||||reported p value is for the physical limitation and treatment satisfaction domains|paired t test|||within group comparison of change from baseline||||>0.05
72341272|NCT02265796|144206241|SUPERIORITY||||||<|0.05||||||reported p value is for the angina stability, angina frequency and quality of life domains|paired t test|||within group comparison of change from baseline||||<0.05
72341273|NCT02265796|144206242|SUPERIORITY|||||||0.58|||||||Fisher Exact|||"between group comparison for the excellent/good"||||0.58
72341274|NCT02265796|144206242|SUPERIORITY|||||||0.8|||||||Fisher Exact|||"Between group analysis for fair/poor"||||0.80
72341275|NCT02265796|144206242|SUPERIORITY|||||||0.5|||||||McNemar|||within group analysis of change from baseline for excellent/good||||0.50
72341276|NCT02265796|144206242|SUPERIORITY|||||||0.48|||||||McNemar|||within group comparison of change from baseline for fair/poor||||0.48
72341277|NCT02265796|144206242|SUPERIORITY|||||||0.19|||||||McNemar|||within group analysis of change from baseline for excellent/good||||0.19
72341278|NCT02265796|144206242|SUPERIORITY|||||||0.067|||||||McNemar|||within group comparison of change from baseline for fair/poor||||0.067
72341279|NCT02265796|144206243|SUPERIORITY||||||>|0.05|||||||Fisher Exact|||||||>0.05
72341280|NCT02963701|144206260|EQUIVALENCE|A claim of bioequivalence was made if the 90% confidence interval (CI) of the geometric means of T/R ratio was contained in the pre-defined acceptance range of 80.00% to 125.00%|T/R Ratio (%)|99.16|STANDARD_DEVIATION|8.49|||TWO_SIDED|90.0|96.52|101.89|||ANOVA|Results are based on ANOVA model on the logarithmic scale including fixed effects for sequence, subject nested within sequence, period and treatment.|The estimated parameter was the adjusted geometric mean ratios (%) of Test and Reference products. The parameter dispersion type (Standard Deviation) was actually the intra-individual geometric coefficient of variation (%).|||101.89|96.52|
72341281|NCT02963701|144206261|EQUIVALENCE|A claim of bioequivalence was made if the 90% confidence interval (CI) of the geometric means of T/R ratio was contained in the pre-defined acceptance range of 80.00% to 125.00%|T/R Ratio (%)|89.16|STANDARD_DEVIATION|19.28|||TWO_SIDED|90.0|83.88|94.76|||ANOVA|Results are based on ANOVA model on the logarithmic scale including fixed effects for sequence, subject nested within sequence, period and treatment.|The estimated parameter was the adjusted geometric mean ratios (%) of Test and Reference products. The parameter dispersion type (Standard Deviation) was actually the intra-individual geometric coefficient of variation (%).|||94.76|83.88|
72341282|NCT02963701|144206262|EQUIVALENCE|A claim of bioequivalence was made if the 90% confidence interval (CI) of the geometric means of T/R ratio was contained in the pre-defined acceptance range of 80.00% to 125.00%.|T/R Ratio (%)|99.75|STANDARD_DEVIATION|12.96|||TWO_SIDED|90.0|95.73|103.95|||ANOVA|Results are based on ANOVA model on the logarithmic scale including fixed effects for sequence, subject nested within sequence, period and treatment.|The estimated parameter was the adjusted geometric mean ratios \[%\] of Test and Reference products. The parameter dispersion type (Standard Deviation) was actually the intra-individual geometric coefficient of variation \[%\].|||103.95|95.73|
72341283|NCT02963701|144206263|EQUIVALENCE|A claim of bioequivalence was made if the 90% confidence interval (CI) of the geometric means of T/R ratio was contained in the pre-defined acceptance range of 80.00% to 125.00%.|T/R Ratio (%)|102.16|STANDARD_DEVIATION|15.37|||TWO_SIDED|90.0|97.3|107.27|||ANOVA|Results are based on ANOVA model on the logarithmic scale including fixed effects for sequence, subject nested within sequence, period and treatment.|The estimated parameter was the adjusted geometric mean ratios \[%\] of Test and Reference products. The parameter dispersion type \[SD\] was actually the intra-individual geometric coefficient of variation \[%\].|||107.27|97.30|
72341284|NCT02963701|144206264|EQUIVALENCE|A claim of bioequivalence was made if the 90% confidence interval (CI) of the geometric means of T/R ratio was contained in the pre-defined acceptance range of 80.00% to 125.00%.|T/R Ratio (%)|98.97|STANDARD_DEVIATION|8.13|||TWO_SIDED|90.0|96.44|101.57|||ANOVA|Results are based on ANOVA model on the logarithmic scale including fixed effects for sequence, subject nested within sequence, period and treatment.|The estimated parameter was the adjusted geometric mean ratios (%)of Test and Reference products. The parameter dispersion type (Standard Deviation) was actually the intra-individual geometric coefficient of variation (%).|||101.57|96.44|
72428466|NCT00432679|144367891|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.718|STANDARD_ERROR_OF_MEAN|0.8102||0.377|TWO_SIDED|95.0|-0.883|2.319|||Unpaired t-test|||||2.319|-0.883|0.377
72428467|NCT00432679|144367892|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-2.04|STANDARD_ERROR_OF_MEAN|2.094||0.33|TWO_SIDED|95.0|-6.18|2.09|||Unpaired t-test|||||2.09|-6.18|0.330
72341285|NCT02963701|144206265|EQUIVALENCE|A claim of bioequivalence was made if the 90% confidence interval (CI) of the geometric means of T/R ratio was contained in the pre-defined acceptance range of 80.00% to 125.00%.|T/R Ratio (%)|99.67|STANDARD_DEVIATION|13.5|||TWO_SIDED|90.0|95.48|104.04|||ANOVA|Results are based on ANOVA model on the logarithmic scale including fixed effects for sequence, subject nested within sequence, period and treatment.|The estimated parameter was the adjusted geometric mean ratios (%) of Test and Reference products. The parameter dispersion type (Standard Deviation) was actually the intra-individual geometric coefficient of variation (%).|||104.04|95.48|
72341286|NCT02963701|144206266|EQUIVALENCE|A claim of bioequivalence was made if the 90% confidence interval (CI) of the geometric means of T/R ratio was contained in the pre-defined acceptance range of 80.00% to 125.00%.|T/R Ratio (%)|95.96|STANDARD_DEVIATION|14.27|||TWO_SIDED|90.0|91.7|100.4|||ANOVA|Results are based on ANOVA model on the logarithmic scale including fixed effects for sequence, subject nested within sequence, period and treatment.|The estimated parameter was the adjusted geometric mean ratios (%) of Test and Reference products. The parameter dispersion type (Standard Deviation) was actually the intra-individual geometric coefficient of variation (%).|||100.40|91.70|
72341287|NCT02963701|144206267|EQUIVALENCE|A claim of bioequivalence was made if the 90% confidence interval (CI) of the geometric means of T/R ratio was contained in the pre-defined acceptance range of 80.00% to 125.00%.|T/R Ratio (%)|96.12|STANDARD_DEVIATION|14.06|||TWO_SIDED|90.0|91.92|100.51|||ANOVA|Results are based on ANOVA model on the logarithmic scale including fixed effects for sequence, subject nested within sequence, period and treatment.|The estimated parameter was the adjusted geometric mean ratios (%) of Test and Reference products. The parameter dispersion type (Standard Deviation) was actually the intra-individual geometric coefficient of variation (%).|||100.51|91.92|
72341288|NCT02963701|144206268|EQUIVALENCE|A claim of bioequivalence was made if the 90% confidence interval (CI) of the geometric means of T/R ratio was contained in the pre-defined acceptance range of 80.00% to 125.00%.|T/R Ratio (%)|90.83|STANDARD_DEVIATION|21.49|||TWO_SIDED|90.0|84.87|97.21|||ANOVA|Results are based on ANOVA model on the logarithmic scale including fixed effects for sequence, subject nested within sequence, period and treatment.|The estimated parameter was the adjusted geometric mean ratios (%) of Test and Reference products. The parameter dispersion type (Standard Deviation) was actually the intra-individual geometric coefficient of variation (%).|||97.21|84.87|
72341289|NCT02963701|144206269|EQUIVALENCE|A claim of bioequivalence was made if the 90% confidence interval (CI) of the geometric means of T/R ratio was contained in the pre-defined acceptance range of 80.00% to 125.00%.|T/R Ratio (%)|101.86|STANDARD_DEVIATION|7.89|||TWO_SIDED|90.0|99.33|104.46|||ANOVA|Results are based on ANOVA model on the logarithmic scale including fixed effects for sequence, subject nested within sequence, period and treatment.|The estimated parameter was the adjusted geometric mean ratios (%) of Test and Reference products. The parameter dispersion type (Standard Deviation) was actually the intra-individual geometric coefficient of variation (%).|||104.46|99.33|
72341290|NCT02963701|144206270|EQUIVALENCE|A claim of bioequivalence was made if the 90% confidence interval (CI) of the geometric means of T/R ratio was contained in the pre-defined acceptance range of 80.00% to 125.00%.|T/R Ratio (%)|101.65|STANDARD_DEVIATION|7.01|||TWO_SIDED|90.0|99.4|103.95|||ANOVA|Results are based on ANOVA model on the logarithmic scale including fixed effects for sequence, subject nested within sequence, period and treatment.|The estimated parameter was the adjusted geometric mean ratios (%) of Test and Reference products. The parameter dispersion type (Standard Deviation) was actually the intra-individual geometric coefficient of variation (%).|||103.95|99.40|
72341291|NCT02963701|144206271|EQUIVALENCE|A claim of bioequivalence was made if the 90% confidence interval (CI) of the geometric means of T/R ratio was contained in the pre-defined acceptance range of 80.00% to 125.00%.|T/R Ratio (%)|86.53|STANDARD_DEVIATION|16.85|||TWO_SIDED|90.0|82.03|91.28|||ANOVA|Results are based on ANOVA model on the logarithmic scale including fixed effects for sequence, subject nested within sequence, period and treatment.|The estimated parameter was the adjusted geometric mean ratios (%) of Test and Reference products. The parameter dispersion type (Standard Deviation) was actually the intra-individual geometric coefficient of variation (%).|||91.28|82.03|
72341292|NCT02963701|144206272|EQUIVALENCE|A claim of bioequivalence was made if the 90% confidence interval (CI) of the geometric means of T/R ratio was contained in the pre-defined acceptance range of 80.00% to 125.00%.|Ratio (%)|106.17|STANDARD_DEVIATION|14.77|||TWO_SIDED|90.0|101.3|111.26|||ANOVA|Results are based on ANOVA model on the logarithmic scale including fixed effects for sequence, subject nested within sequence, period and treatment.|The estimated parameter was the adjusted geometric mean ratios (%) of Test and Reference products. The parameter dispersion type (Standard Deviation) was actually the intra-individual geometric coefficient of variation (%).|||111.26|101.30|
72341293|NCT02530996|144206326|OTHER|Power calculations were performed using G\*Power computer software version 3. Sample-size calculations were based on the number of patients needed to detect significant differences in FMD between placebo and BH4.|Mean Difference (Net)|1.5|||<|0.05|TWO_SIDED||||||t-test, 2 sided|||Statistics were performed using SPSS software (IBM, Chicago, IL). Paired t-tests were used to identify significant changes in measured variables between placebo and BH4. Unpaired t-tests were used to identify significant changes in measured variables between ordered groups. Based on data published in PMID: 25511849 power calculations for this study of SSc patients were made.||||<0.05
72341294|NCT04268745|144206372|SUPERIORITY||Mean Difference (Final Values)|-13.603||||0.027|TWO_SIDED|95.0|-25.634|-1.573|||Regression, Linear|||||-1.573|-25.634|0.027
72341295|NCT04268745|144206373|SUPERIORITY||Median Difference (Final Values)|6.405||||0.0001|TWO_SIDED|95.0|4.474|8.335|||Regression, Linear|||||8.335|4.474|0.0001
72341296|NCT04268745|144206374|SUPERIORITY||Mean Difference (Final Values)|-18.703||||0.0002|TWO_SIDED|95.0|-28.235|-9.172|||Regression, Linear|||||-9.172|-28.235|0.0002
72341297|NCT04268745|144206375|SUPERIORITY||Mean Difference (Final Values)|8.556||||0.028|TWO_SIDED|95.0|0.938|16.174|||Regression, Linear|||||16.174|0.938|0.028
72341298|NCT04268745|144206376|SUPERIORITY||Mean Difference (Final Values)|0.111||||0.695|TWO_SIDED|95.0|-0.443|0.665|||Regression, Linear|||||0.665|-0.443|0.695
72341299|NCT04268745|144206377|SUPERIORITY||Mean Difference (Final Values)|-0.514||||0.469|TWO_SIDED|95.0|-1.901|0.874|||Regression, Linear|||||0.874|-1.901|0.469
72341300|NCT03344172|144206401|SUPERIORITY||Odds Ratio (OR)|0.52||||0.63|TWO_SIDED|95.0|0.3|6.71|||Fisher Exact|||||6.71|0.30|0.63
72341301|NCT03344172|144206402|SUPERIORITY||Mean Difference (Final Values)|-0.63|STANDARD_DEVIATION|0.52||0.13|TWO_SIDED|95.0|-1.0|-0.25|||t-test, 2 sided|||||-0.25|-1.00|0.13
72341302|NCT03242252|144206421|SUPERIORITY||Difference in Least Squares (LS) Means|-0.1|STANDARD_ERROR_OF_MEAN|0.076||0.2095|TWO_SIDED|95.0|-0.245|0.054|||ANCOVA|||The change from baseline to Week 26 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of mean SBP (\<130, ≥130 mmHg) at screening, randomization stratum of Chronic Kidney Disease (CKD) stage (3A, 3B) at screening, and country as fixed effects, and baseline HbA1c as a covariate.||0.054|-0.245|0.2095
72341303|NCT03242252|144206421|SUPERIORITY||Difference in LS Means|-0.24|STANDARD_ERROR_OF_MEAN|0.077||0.0021|TWO_SIDED|95.0|-0.386|-0.085|||ANCOVA|||The change from baseline to Week 26 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of mean SBP (\<130, ≥130 mmHg) at screening, randomization stratum of CKD stage (3A, 3B) at screening, and country as fixed effects, and baseline HbA1c as a covariate.||-0.085|-0.386|0.0021
72341304|NCT03242252|144206422|SUPERIORITY||Difference in LS Means|-0.587|STANDARD_ERROR_OF_MEAN|0.2397||0.0144|TWO_SIDED|95.0|-1.0564|-0.1169|||ANCOVA|||The change from baseline to Week 26 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of mean SBP (\<130, ≥130 mmHg) at screening, randomization stratum of CKD stage (3A, 3B) at screening, and country as fixed effects, and baseline FPG as a covariate.||-0.1169|-1.0564|0.0144
72341305|NCT03242252|144206422|SUPERIORITY||Difference in LS Means|-0.478|STANDARD_ERROR_OF_MEAN|0.2368||0.0436|TWO_SIDED|95.0|-0.942|-0.0136|||ANCOVA|||The change from baseline to Week 26 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of mean SBP (\<130, ≥130 mmHg) at screening, randomization stratum of CKD stage (3A, 3B) at screening, and country as fixed effects, and baseline FPG as a covariate.||-0.0136|-0.942|0.0436
72341306|NCT03242252|144206423|SUPERIORITY||Difference in LS Means|-2.28|STANDARD_ERROR_OF_MEAN|2.034||0.2627|TWO_SIDED|95.0|-6.265|1.709|||ANCOVA|||The change from baseline to Week 12 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization stratum of CKD stage (3A, 3B) at screening, and country as fixed effects, and baseline SBP as a covariate.||1.709|-6.265|0.2627
72341307|NCT03242252|144206423|SUPERIORITY||Difference in LS Means|-2.53|STANDARD_ERROR_OF_MEAN|1.799||0.1602|TWO_SIDED|95.0|-6.052|1.0|||ANCOVA|||The change from baseline to Week 12 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization stratum of CKD stage (3A, 3B) at screening, and country as fixed effects, and baseline SBP as a covariate.||1|-6.052|0.1602
72341308|NCT03242252|144206424|SUPERIORITY||Difference in LS Means|-1.59|STANDARD_ERROR_OF_MEAN|1.301||0.2212|TWO_SIDED|95.0|-4.142|0.958|||ANCOVA|||The change from baseline to Week 12 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of mean SBP (\<130, ≥130 mmHg) at screening, randomization stratum of CKD stage (3A, 3B) at screening, country as fixed effects, and baseline SBP as a covariate.||0.958|-4.142|0.2212
72341309|NCT03242252|144206424|SUPERIORITY||Difference in LS Means|-1.63|STANDARD_ERROR_OF_MEAN|1.297||0.2089|TWO_SIDED|95.0|-4.171|0.912|||ANCOVA|||The change from baseline to Week 12 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of mean SBP (\<130, ≥130 mmHg) at screening, randomization stratum of CKD stage (3A, 3B) at screening, country as fixed effects, and baseline SBP as a covariate.||0.912|-4.171|0.2089
72341310|NCT03242252|144206425|SUPERIORITY||Difference in LS Means|-1.28|STANDARD_ERROR_OF_MEAN|0.326|<|0.0001|TWO_SIDED|95.0|-1.92|-0.644|||ANCOVA|||The change from baseline to Week 26 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of mean SBP (\<130, ≥130 mmHg) at screening, randomization stratum of CKD stage (3A, 3B) at screening, country as fixed effects, and baseline body weight as a covariate.||-0.644|-1.92|< 0.0001
72341311|NCT03242252|144206425|SUPERIORITY||Difference in LS Means|-0.82|STANDARD_ERROR_OF_MEAN|0.339||0.0155|TWO_SIDED|95.0|-1.487|-0.156|||ANCOVA|||The change from baseline to Week 26 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of mean SBP (\<130, ≥130 mmHg) at screening, randomization stratum of CKD stage (3A, 3B) at screening, country as fixed effects, and baseline body weight as a covariate.||-0.156|-1.487|0.0155
72341312|NCT03242252|144206426|SUPERIORITY||Percent Difference|-30.72||||0.0015|TWO_SIDED|95.0|-44.78|-13.07|||ANCOVA|||The change from baseline to Week 26 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of mean SBP (\<130, ≥130 mmHg) at screening, randomization stratum of CKD stage (3A, 3B) at screening, country as fixed effects, and and log-transformed baseline UACR as a covariate.||-13.07|-44.78|0.0015
72341313|NCT03242252|144206426|SUPERIORITY||Percent Difference|-36.18||||0.0003|TWO_SIDED|95.0|-49.91|-18.68|||ANCOVA|||The change from baseline to Week 26 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of mean SBP (\<130, ≥130 mmHg) at screening, randomization stratum of CKD stage (3A, 3B) at screening, country as fixed effects, and and log-transformed baseline UACR as a covariate.||-18.68|-49.91|0.0003
72341314|NCT03242252|144206427|SUPERIORITY||Percentage Difference|1.5||||0.4328|TWO_SIDED|95.0|-2.23|5.21|||Cochran-Mantel-Haenszel|||Percentage difference between treatment groups using the Cochran-Mantel-Haenszel test stratified by the randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of mean SBP (\<130, ≥130 mmHg) at screening and randomization strata of CKD stage (3A, 3B) at screening.||5.21|-2.23|0.4328
72341315|NCT03242252|144206427|SUPERIORITY||Percentage Difference|1.5||||0.4328|TWO_SIDED|95.0|-2.2|5.17|||Cochran-Mantel-Haenszel|||Percentage difference between treatment groups using the Cochran-Mantel-Haenszel test stratified by the randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of mean SBP (\<130, ≥130 mmHg) at screening and randomization strata of CKD stage (3A, 3B) at screening.||5.17|-2.2|0.4328
72341316|NCT03242252|144206428|SUPERIORITY||Percentage Difference|6.0||||0.0614|TWO_SIDED|95.0|-0.23|12.21|||Cochran-Mantel-Haenszel|||Percentage difference between treatment groups using the Cochran-Mantel-Haenszel test stratified by the randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of mean SBP (\<130, ≥130 mmHg) at screening and randomization strata of CKD stage (3A, 3B) at screening.||12.21|-0.23|0.0614
72428468|NCT00432679|144367893|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.01|STANDARD_ERROR_OF_MEAN|0.473||0.983|TWO_SIDED|95.0|-0.945|0.925|||Unpaired t-test|||||0.925|-0.945|0.983
72341317|NCT03242252|144206428|SUPERIORITY||Percentage Difference|7.4||||0.023|TWO_SIDED|95.0|1.08|13.65|||Cochran-Mantel-Haenszel|||Percentage difference between treatment groups using the Cochran-Mantel-Haenszel test stratified by the randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of mean SBP (\<130, ≥130 mmHg) at screening and randomization strata of CKD stage (3A, 3B) at screening.||13.65|1.08|0.023
72341318|NCT01116427|144206435|SUPERIORITY_OR_OTHER|||||||0.87|TWO_SIDED|||||Analysis was stratified on the presence or absence of subclinical activity as demonstrated by a Gd-enhanced lesion on one MRI in the past year prior to enrollment.|Wilcoxon (Mann-Whitney)|||||||0.87
72341319|NCT01116427|144206436|SUPERIORITY_OR_OTHER|||||||0.36|TWO_SIDED|||||Wilcoxon rank sum test in which the total number of new lesions were converted to ranks and then compared between groups|Wilcoxon (Mann-Whitney)|||||||0.36
72341320|NCT01116427|144206437|SUPERIORITY_OR_OTHER|||||||0.93|TWO_SIDED|||||Rank sum test in which the lesion volume change values per participant were converted to ranks and compared between the treatment groups|Wilcoxon (Mann-Whitney)|||||||0.93
72341321|NCT01116427|144206438|SUPERIORITY_OR_OTHER|||||||0.68|TWO_SIDED|||||Wilcoxon rank sum test in which percent brain volume change values per participant were converted to ranks and the ranks were compared between groups|Wilcoxon (Mann-Whitney)|||||||0.68
72341322|NCT01116427|144206439|SUPERIORITY_OR_OTHER|||||||0.21|TWO_SIDED|||||Wilcoxon rank sum test in which mean numbers of new lesions per participant were converted to ranks and compared between groups|Wilcoxon (Mann-Whitney)|||||||0.21
72341323|NCT01116427|144206440|SUPERIORITY_OR_OTHER|||||||0.65|TWO_SIDED||||||Fisher Exact|||||||0.65
72341324|NCT01116427|144206442|SUPERIORITY_OR_OTHER|||||||0.13|TWO_SIDED|||||Wilcoxon rank sum test in which the change from baseline scores per subject were converted to ranks and compared between treatment groups|Wilcoxon (Mann-Whitney)|||||||0.13
72341325|NCT01116427|144206443|SUPERIORITY_OR_OTHER|||||||0.06|TWO_SIDED|||||Analysis was stratified on the presence or absence of subclinical activity as demonstrated by a Gd-enhanced lesion on one MRI in the past year prior to enrollment.|Wilcoxon (Mann-Whitney)|||||||0.06
72341326|NCT01116427|144206444|SUPERIORITY_OR_OTHER|||||||0.07|TWO_SIDED|||||Rank sum test in which the lesion volume change values per participant were converted to ranks and compared between the treatment groups|Wilcoxon (Mann-Whitney)|||||||0.07
72341327|NCT01116427|144206445|SUPERIORITY_OR_OTHER|||||||0.88|TWO_SIDED|||||Wilcoxon rank sum test in which the percent brain volume change values per participant were converted to ranks and compared between treatment groups|Wilcoxon (Mann-Whitney)|||||||0.88
72341328|NCT01116427|144206446|SUPERIORITY_OR_OTHER|||||||0.29|TWO_SIDED||||||Fisher Exact|||||||0.29
72341329|NCT01116427|144206448|SUPERIORITY_OR_OTHER|||||||0.67|TWO_SIDED|||||Wilcoxon rank sum test in which the change from baseline scores per participant were converted to ranks and compared between treatment groups|Wilcoxon (Mann-Whitney)|||||||0.67
72341330|NCT03973905|144206453|OTHER||Vaccine Effectiveness|65.26|||||TWO_SIDED|95.0|-64.93|92.68|||||Vaccine Effectiveness (VE) was estimated as (1-odds ratio) × 100%. The Confidence Interval was calculated based on the conditional binomial distribution of cases in the exposed group and the total number of cases.|To assess the effectiveness of maternal vaccination with Boostrix during third trimester of pregnancy (at least 14 days before delivery) at preventing pertussis in infants \<2 months||92.68|-64.93|
72341331|NCT03973905|144206454|OTHER||Vaccine Effectiveness|42.01|||||TWO_SIDED|95.0|-1071.8|97.13|||||VE was estimated as (1-odds ratio) × 100%. The Confidence Interval was calculated based on the conditional binomial distribution of cases in the exposed group and the total number of cases.|To assess the effectiveness of maternal vaccination with Boostrix before pregnancy at preventing pertussis in infants \<2 months||97.13|-1071.80|
72341332|NCT03973905|144206454|OTHER||Vaccine Effectiveness|62.17|||||TWO_SIDED|95.0|-439.75|97.35|||||VE was estimated as (1-odds ratio) × 100%. The Confidence Interval was calculated based on the conditional binomial distribution of cases in the exposed group and the total number of cases.|To assess the effectiveness of maternal vaccination with Boostrix during first or second trimester of pregnancy at preventing pertussis in infants \<2 months||97.35|-439.75|
72341333|NCT03973905|144206454|OTHER||Vaccine Effectiveness|-12.89|||||TWO_SIDED|95.0|-166.37|52.16|||||VE was estimated as (1-odds ratio) × 100%. The Confidence Interval was calculated based on the conditional binomial distribution of cases in the exposed group and the total number of cases.|To assess the effectiveness of maternal vaccination with Boostrix after pregnancy at preventing pertussis in infants \<2 months||52.16|-166.37|
72341334|NCT03973905|144206455|OTHER||Vaccine Effectiveness|64.79|||||TWO_SIDED|95.0|-57.51|92.13|||||VE was estimated as (1-odds ratio) × 100%. The Confidence Interval was calculated based on the conditional binomial distribution of cases in the exposed group and the total number of cases.|To assess the effectiveness of maternal vaccination with Boostrix at any time during pregnancy at preventing pertussis in infants \<2 months||92.13|-57.51|
72341335|NCT03973905|144206456|OTHER||Vaccine Effectiveness|17.65|||||TWO_SIDED|95.0|-12529.0|99.46|||||VE was estimated as (1-odds ratio) × 100%. The Confidence Interval was calculated based on the conditional binomial distribution of cases in the exposed group and the total number of cases.|To assess the effectiveness of maternal vaccination with Boostrix before pregnancy at preventing pertussis in infants \<2 months||99.46|-12529.0|
72341336|NCT03973905|144206456|OTHER||Vaccine Effectiveness|85.01|||||TWO_SIDED|95.0|-13.91|98.03|||||VE was estimated as (1-odds ratio) × 100%. The Confidence Interval was calculated based on the conditional binomial distribution of cases in the exposed group and the total number of cases.|To assess the effectiveness of maternal vaccination with Boostrix during third trimester of pregnancy at preventing pertussis in infants \<2 months||98.03|-13.91|
72341337|NCT03973905|144206456|OTHER||Vaccine Effectiveness|37.64|||||TWO_SIDED|95.0|-87.4|79.25|||||VE was estimated as (1-odds ratio) × 100%. The Confidence Interval was calculated based on the conditional binomial distribution of cases in the exposed group and the total number of cases.|To assess the effectiveness of maternal vaccination with Boostrix after pregnancy at preventing pertussis in infants \<2 months||79.25|-87.40|
72341338|NCT02648217|144206457|SUPERIORITY_OR_OTHER||Treatment Contrast|0.02||||0.8426|TWO_SIDED|95.0|-0.2|0.24|||Mixed model for repeated measurements|||The endpoint was analysed using mixed model for repeated measurements (MMRM) with an unstructured covariance matrix. The model included treatment, sex, region, previous OAD treatment, pre-Ramadan trial exposure and visit as factors and age and baseline value of the endpoint as covariates. Interactions between visit and all factors and covariates are included in the model.||0.24|-0.20|0.8426
72341339|NCT02411929|144206569|SUPERIORITY_OR_OTHER||Test (oral)/Reference (IV) of means|104.73|||||TWO_SIDED|90.0|101.64|107.91|||||Natural log transformed AUCinf(dn) and AUClast(dn) from Period 1 were analyzed using a mixed effect model with treatment as a fixed effect and participant as a random effect. The adjusted mean differences were exponentiated.|Ratio - Test (oral) / Reference (IV) of means||107.91|101.64|
72341340|NCT02411929|144206579|SUPERIORITY_OR_OTHER||Ratio|110.71|||||||||||||The ratio (Test/Reference) of the geometric means of dose normalized natural log transformed Total 14\^C in Urine will be estimated. Total 14\^C\_Urine\_IV is the Reference formulation and Total 14C\_Urine\_Oral is the Test formulation (expressed as a %).|Ratio - Test (Oral) / Reference (IV) (%)||||
72341341|NCT02715726|144206582|SUPERIORITY||LS mean difference|-35.6|||<|0.0001|TWO_SIDED|95.0|-40.6|-30.7||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab 75 mg Q2W/up to 150 mg Q2W vs. Ezetimibe|Alirocumab group was compared to ezetimibe group using an appropriate contrast statement.||-30.7|-40.6|<0.0001
72341342|NCT02715726|144206583|SUPERIORITY||LS mean difference|-37.3|||<|0.0001|TWO_SIDED|95.0|-42.1|-32.6||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab 75 mg Q2W/up to 150 mg Q2W vs. Ezetimibe|A hierarchical testing method was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when previous endpoint was statistically significant at 0.05 level.||-32.6|-42.1|<0.0001
72341343|NCT02715726|144206584|SUPERIORITY||LS mean difference|-34.9|||<|0.0001|TWO_SIDED|95.0|-39.5|-30.2||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab 75 mg Q2W/up to 150 mg Q2W vs. Ezetimibe|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-30.2|-39.5|<0.0001
72341344|NCT02715726|144206585|SUPERIORITY||LS mean difference|-35.4|||<|0.0001|TWO_SIDED|95.0|-40.0|-30.7||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab 75 mg Q2W/up to 150 mg Q2W vs. Ezetimibe|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-30.7|-40.0|<0.0001
72341345|NCT02715726|144206586|SUPERIORITY|Threshold for significance at 0.05 level.|LS mean difference|-27.4|||<|0.0001|TWO_SIDED|95.0|-30.8|-23.9||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab 75 mg Q2W/up to 150 mg Q2W vs. Ezetimibe|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-23.9|-30.8|<0.0001
72341346|NCT02715726|144206587|SUPERIORITY||LS mean difference|-27.8|||<|0.0001|TWO_SIDED|95.0|-31.2|-24.4||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab 75 mg Q2W/up to 150 mg Q2W vs. Ezetimibe|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-24.4|-31.2|<0.0001
72341347|NCT02715726|144206588|SUPERIORITY||LS mean difference|-27.7|||<|0.0001|TWO_SIDED|95.0|-31.8|-23.6||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab 75 mg Q2W/up to 150 mg Q2W vs. Ezetimibe|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-23.6|-31.8|<0.0001
72341348|NCT02715726|144206589|SUPERIORITY||LS mean difference|-28.7|||<|0.0001|TWO_SIDED|95.0|-32.6|-24.7||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab 75 mg Q2W/up to 150 mg Q2W vs. Ezetimibe|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-24.7|-32.6|<0.0001
72341349|NCT02715726|144206590|SUPERIORITY||LS mean difference|-20.2|||<|0.0001|TWO_SIDED|95.0|-23.1|-17.2||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab 75 mg Q2W/up to 150 mg Q2W vs. Ezetimibe|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-17.2|-23.1|<0.0001
72341350|NCT02715726|144206591|SUPERIORITY||LS mean difference|-26.5|||<|0.0001|TWO_SIDED|95.0|-29.8|-23.2||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab 75 mg Q2W/up to 150 mg Q2W vs. Ezetimibe|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-23.2|-29.8|<0.0001
72341351|NCT02715726|144206592|SUPERIORITY||LS mean difference|-26.7|||<|0.0001|TWO_SIDED|95.0|-30.5|-22.8||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab 75 mg Q2W/up to 150 mg Q2W vs. Ezetimibe|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-22.8|-30.5|<0.0001
72341352|NCT02715726|144206593|SUPERIORITY||LS mean difference|-19.3|||<|0.0001|TWO_SIDED|95.0|-22.1|-16.5||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab 75 mg Q2W/up to 150 mg Q2W vs. Ezetimibe|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-16.5|-22.1|<0.0001
72341353|NCT02715726|144206594|SUPERIORITY||Odds Ratio (OR)|11.2|||<|0.0001|TWO_SIDED|95.0|7.1|17.7||Threshold for significance at 0.05 level.|Regression, Logistic|Multiple imputation approach followed by logistic regression model.|Alirocumab 75 mg Q2W/up to 150 mg Q2W vs Ezetimibe|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||17.7|7.1|<0.0001
72341354|NCT02715726|144206595|SUPERIORITY||Odds Ratio (OR)|13.6|||<|0.0001|TWO_SIDED|95.0|8.3|22.3||Threshold for significance at 0.05 level.|Regression, Logistic|Multiple imputation approach followed by logistic regression model.|Alirocumab 75 mg Q2W/up to 150 mg Q2W vs Ezetimibe|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||22.3|8.3|<0.0001
72341355|NCT02715726|144206596|SUPERIORITY||Adjusted Mean Difference|-34.273|||<|0.0001|TWO_SIDED|95.0|-39.262|-29.285||Threshold for significance at 0.05 level.|Regression, Robust|Multiple imputation approach followed by a robust regression model.|Alirocumab 75 mg Q2W/up to 150 mg Q2W vs. Ezetimibe|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-29.285|-39.262|<0.0001
72341356|NCT02715726|144206597|SUPERIORITY||LS mean difference|1.9||||0.228|TWO_SIDED|95.0|-1.2|4.9||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab 75 mg Q2W/up to 150 mg Q2W vs. Ezetimibe|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||4.9|-1.2|0.2280
72341357|NCT04405245|144206647|SUPERIORITY||Mean Difference (Final Values)|0.09|STANDARD_ERROR_OF_MEAN|0.366||0.807|TWO_SIDED|95.0|-0.63|0.81|||ANCOVA|||||0.81|-0.63|0.8070
72341358|NCT04405245|144206647|SUPERIORITY||Mean Difference (Final Values)|-0.92|STANDARD_ERROR_OF_MEAN|0.365||0.013|TWO_SIDED|95.0|-1.64|-0.2|||ANCOVA|||||-0.20|-1.64|0.0130
72341359|NCT02391961|144206656|SUPERIORITY|||||||0.842672|||||||ANOVA|||Statistical Analysis applies to the 4 subgroups: average PSR at baseline and after 3 hours on dalfampridine, and average PSR at baseline and after 3 hours on placebo.||||0.842672
72341360|NCT02391961|144206657|SUPERIORITY|||||||0.972866|||||||ANOVA|||Statistical Analysis applies to the 4 subgroups: average PTD at baseline and after 3 hours on dalfampridine, and average PTD at baseline and after 3 hours on placebo.||||0.972866
72341361|NCT02391961|144206658|SUPERIORITY|||||||0.95|||||||ANOVA|||Statistical Analysis applies to the 4 subgroups: RA at baseline and after 3 hours on dalfampridine, and RA at baseline and after 3 hours on placebo.||||0.95
72341362|NCT02391961|144206659|SUPERIORITY|||||||0.9|||||||ANOVA|||Statistical Analysis applies to the 4 subgroups: MRS at baseline and after 3 hours on dalfampridine, and MRS at baseline and after 3 hours on placebo.||||0.9
72341363|NCT02391961|144206660|SUPERIORITY|||||||0.990995|||||||ANOVA|||Statistical Analysis applies to the 4 subgroups: 25 FWT at baseline and after 3 hours on dalfampridine, and 25 FWT at baseline and after 3 hours on placebo.||||0.990995
72341364|NCT02391961|144206661|SUPERIORITY|||||||0.71|||||||Wilcoxon (Mann-Whitney)|||Statistical Analysis applies to the 2 groups, mean VFQ-25 scores on dalfampridine vs mean VFQ-25 scores on placebo||||0.71
72341365|NCT02391961|144206662|SUPERIORITY|||||||0.95|||||||Wilcoxon (Mann-Whitney)|||Statistical Analysis applies to the 2 groups, mean 10-item NOS scores on dalfampridine vs mean 10-item NOS scores on placebo||||0.95
72341366|NCT02219503|144206673|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The non-inferiority of the Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir regimen in SVR12 to a historical threshold for sofosbuvir plus pegIFN/ ribavirin (RBV) for the treatment of participants with HCV Genotype 1b (GT1b) infection and cirrhosis was calculated using a 2-sided 95% CI from Wilson's score method. Non-inferiority was to be declared if the lower confidence bound was greater than 72.7%.|Percentage of Participants|100.0|||||TWO_SIDED|95.0|94.0|100.0|||||95% confidence interval (CI) was calculated using Wilson score method.|||100.0|94.0|
72341367|NCT02219503|144206673|SUPERIORITY_OR_OTHER_LEGACY||Percentage of Participants|100.0|||||TWO_SIDED|95.0|94.0|100.0|||||95% confidence interval (CI) was calculated using Wilson score method.|The superiority of the Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir regimen in SVR12 to a historical threshold for sofosbuvir plus pegIFN/ ribavirin (RBV) for the treatment of participants with HCV Genotype 1b (GT1b) infection and cirrhosis was calculated using a 2-sided 95% CI from Wilson's score method. Superiority was declared if the lower confidence bound was greater than 83.2%.||100.0|94.0|
72341368|NCT00343382|144206706|SUPERIORITY_OR_OTHER|||||||0.1675|||||||Kruskal-Wallis|||||||0.1675
72341369|NCT00343382|144206706|SUPERIORITY_OR_OTHER|||||||0.5974|||||||Kruskal-Wallis|||||||0.5974
72341370|NCT00343382|144206707|SUPERIORITY_OR_OTHER|||||||0.002|||||||Kruskal-Wallis|||Comparison of Rigors among arms.||||0.002
72341371|NCT00343382|144206707|SUPERIORITY_OR_OTHER|||||||0.006|||||||Kruskal-Wallis|||Comparison of Urinary Frequency among arms||||0.006
72341372|NCT00343382|144206707|SUPERIORITY_OR_OTHER|||||||0.03|||||||Kruskal-Wallis|||Comparison of nausea among arms||||0.030
72341373|NCT00343382|144206707|SUPERIORITY_OR_OTHER|||||||0.062|||||||Kruskal-Wallis|||Comparison of sweating among arms||||0.062
72341374|NCT03945019|144206710|SUPERIORITY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|Stratified by Previous biologic agent and/or JAK inhibitors exposure, Use of oral corticosteroids treatment at Week 0, Clinical remission at Week 10.||||||<0.0001
72341375|NCT03945019|144206711|SUPERIORITY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|Stratified by Previous biologic agent and/or JAK inhibitors exposure, Use of oral corticosteroids treatment at Week 0, Clinical remission at Week 10.||||||<0.0001
72341376|NCT01985360|144206761|OTHER||Hazard Ratio (HR)|1.01|||||TWO_SIDED|95.0|0.79|1.29||||||||1.29|0.79|
72341377|NCT02914561|144206762|SUPERIORITY||Stratified Percentage Difference|12.7||||0.0017|TWO_SIDED|95.0|4.7|20.7|||Cochran-Mantel-Haenszel|||Cochran-Mantel-Haenszel (CMH) test was stratified by concomitant use of oral, systemic corticosteroids (Yes/No) and of immunomodulators (Yes/No) at Day 1, and number of prior exposures to biologic agent (0, \>=1).||20.7|4.7|0.0017
72341378|NCT02914561|144206762|SUPERIORITY||Stratified Percentage Difference|5.2||||0.173|TWO_SIDED|95.0|-2.4|12.7|||Cochran-Mantel-Haenszel|||CMH test was stratified by concomitant use of oral, systemic corticosteroids (Yes/No) and of immunomodulators (Yes/No) at Day 1, and number of prior exposures to biologic agent (0, \>=1).||12.7|-2.4|0.1730
72341379|NCT02914561|144206762|SUPERIORITY||Stratified Percentage Difference|12.0||||0.0023|TWO_SIDED|95.0|4.1|19.9|||Cochran-Mantel-Haenszel|||CMH test was stratified by concomitant use of oral, systemic corticosteroids (Yes/No) and of immunomodulators (Yes/No) at Day 1, and number of prior exposures to biologic agent (\<=1, \>1).||19.9|4.1|0.0023
72341380|NCT02914561|144206762|SUPERIORITY||Stratified Percentage Difference|1.8||||0.6038|TWO_SIDED|95.0|-5.2|8.7|||Cochran-Mantel-Haenszel|||CMH test was stratified by concomitant use of oral, systemic corticosteroids (Yes/No) and of immunomodulators (Yes/No) at Day 1, and number of prior exposures to biologic agent (\<=1, \>1).||8.7|-5.2|0.6038
72341381|NCT02914561|144206763|SUPERIORITY||Stratified Percentage Difference|5.5||||0.1365|TWO_SIDED|95.0|-2.0|12.9|||Cochran-Mantel-Haenszel|CMH test stratified by use of corticosteroids (Yes/No), immunomodulators (Yes/No), and prior exposure to biologic agents (0, \>=1) at Day 1.||CMH test was stratified by concomitant use of oral, systemic corticosteroids (Yes/No) and of immunomodulators (Yes/No) at Day 1, and number of prior exposures to biologic agent (0, \>=1).||12.9|-2.0|0.1365
72341382|NCT02914561|144206763|SUPERIORITY||Stratified Percentage Difference|2.4||||0.5103|TWO_SIDED|95.0|-4.8|9.5|||Cochran-Mantel-Haenszel|||CMH test was stratified by concomitant use of oral, systemic corticosteroids (Yes/No) and of immunomodulators (Yes/No) at Day 1, and number of prior exposures to biologic agent (0, \>=1).||9.5|-4.8|0.5103
72341383|NCT02914561|144206763|SUPERIORITY||Stratified Percentage Difference|0.1||||0.9797|TWO_SIDED|95.0|-6.5|6.6|||Cochran-Mantel-Haenszel|CMH test stratified by use of corticosteroids (Yes/No), immunomodulators (Yes/No), and prior exposure to biologic agents (\<=1, \>1) at Day 1.||CMH test was stratified by concomitant use of oral, systemic corticosteroids (Yes/No) and of immunomodulators (Yes/No) at Day 1, and number of prior exposures to biologic agent (\<=1, \>1).||6.6|-6.5|0.9797
72428469|NCT00432679|144367894|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|8.22|STANDARD_ERROR_OF_MEAN|3.556||0.022|TWO_SIDED|95.0|1.191|15.248|||Unpaired t-test|||||15.248|1.191|0.022
72341384|NCT02914561|144206763|SUPERIORITY||Stratified Percentage Difference|2.4||||0.4264|TWO_SIDED|95.0|-3.9|8.8|||Cochran-Mantel-Haenszel|||CMH test was stratified by concomitant use of oral, systemic corticosteroids (Yes/No) and of immunomodulators (Yes/No) at Day 1, and number of prior exposures to biologic agent (\<=1, \>1).||8.8|-3.9|0.4264
72341385|NCT02914561|144206764|SUPERIORITY||Stratified Percentage Difference|13.7||||0.0839|TWO_SIDED|95.0|-1.0|28.4|||Cochran-Mantel-Haenszel|||CMH test was stratified by concomitant use of immunomodulators (Yes/No), at Maintenance baseline, and history of exposure to a biologic agent (Yes/No).||28.4|-1.0|0.0839
72341386|NCT02914561|144206764|SUPERIORITY||Stratified Percentage Difference|1.5||||0.8288|TWO_SIDED|95.0|-12.1|15.0|||Cochran-Mantel-Haenszel|||CMH test was stratified by concomitant use of immunomodulators (Yes/No), at Maintenance baseline, and history of exposure to a biologic agent (Yes/No).||15.0|-12.1|0.8288
72341387|NCT02914561|144206765|SUPERIORITY||Stratified Percentage Difference|20.6||||0.0038|TWO_SIDED|95.0|8.2|33.1|||Cochran-Mantel-Haenszel|||CMH test was stratified by concomitant use of immunomodulators (Yes/No), at Maintenance baseline, and history of exposure to a biologic agent (Yes/No).||33.1|8.2|0.0038
72341388|NCT02914561|144206765|SUPERIORITY||Stratified Percentage Difference|5.8||||0.3466|TWO_SIDED|95.0|-6.6|18.3|||Cochran-Mantel-Haenszel|||CMH test was stratified by concomitant use of immunomodulators (Yes/No), at Maintenance baseline, and history of exposure to a biologic agent (Yes/No).||18.3|-6.6|0.3466
72341389|NCT02914561|144206766|SUPERIORITY||Stratified Percentage Difference|6.9||||0.0963|TWO_SIDED|95.0|-1.4|15.2|||Cochran-Mantel-Haenszel|||CMH test was stratified by concomitant use of oral, systemic corticosteroids (Yes/No) and of immunomodulators (Yes/No) at Day 1, and number of prior exposures to biologic agent (0, \>=1).||15.2|-1.4|0.0963
72341390|NCT02914561|144206766|SUPERIORITY||Stratified Percentage Difference|4.2||||0.305|TWO_SIDED|95.0|-3.9|12.2|||Cochran-Mantel-Haenszel|||CMH test was stratified by concomitant use of oral, systemic corticosteroids (Yes/No) and of immunomodulators (Yes/No) at Day 1, and number of prior exposures to biologic agent (0, \>=1).||12.2|-3.9|0.3050
72341391|NCT02914561|144206766|SUPERIORITY||Stratified Percentage Difference|11.9||||0.0039|TWO_SIDED|95.0|3.7|20.2|||Cochran-Mantel-Haenszel|||CMH test was stratified by concomitant use of oral, systemic corticosteroids (Yes/No) and of immunomodulators (Yes/No) at Day 1, and number of prior exposures to biologic agent (\<=1, \>1).||20.2|3.7|0.0039
72341392|NCT02914561|144206766|SUPERIORITY||Stratified Percentage Difference|1.1||||0.7556|TWO_SIDED|95.0|-6.2|8.5|||Cochran-Mantel-Haenszel|||CMH test was stratified by concomitant use of oral, systemic corticosteroids (Yes/No) and of immunomodulators (Yes/No) at Day 1, and number of prior exposures to biologic agent (\<=1, \>1).||8.5|-6.2|0.7556
72341393|NCT02914561|144206767|SUPERIORITY||Stratified Percentage Difference|12.0||||0.0074|TWO_SIDED|95.0|3.2|20.8|||Cochran-Mantel-Haenszel|||CMH test was stratified by concomitant use of oral, systemic corticosteroids (Yes/No) and of immunomodulators (Yes/No) at Day 1, and number of prior exposures to biologic agent (0, ≥1).||20.8|3.2|0.0074
72341394|NCT02914561|144206767|SUPERIORITY||Stratified Percentage Difference|5.5||||0.2159|TWO_SIDED|95.0|-3.2|14.1|||Cochran-Mantel-Haenszel|||CMH test was stratified by concomitant use of oral, systemic corticosteroids (Yes/No) and of immunomodulators (Yes/No) at Day 1, and number of prior exposures to biologic agent (0, ≥1).||14.1|-3.2|0.2159
72341395|NCT02914561|144206767|SUPERIORITY||Stratified Percentage Difference|11.6||||0.011|TWO_SIDED|95.0|2.6|20.6|||Cochran-Mantel-Haenszel|||CMH test was stratified by concomitant use of oral, systemic corticosteroids (Yes/No) and of immunomodulators (Yes/No) at Day 1, and number of prior exposures to biologic agent (\<=1, \>1).||20.6|2.6|0.0110
72341396|NCT02914561|144206767|SUPERIORITY||Stratified Percentage Difference|8.2||||0.0593|TWO_SIDED|95.0|-0.4|16.7|||Cochran-Mantel-Haenszel|||CMH test was stratified by concomitant use of oral, systemic corticosteroids (Yes/No) and of immunomodulators (Yes/No) at Day 1, and number of prior exposures to biologic agent (\<=1, \>1).||16.7|-0.4|0.0593
72341397|NCT02914561|144206768|SUPERIORITY||Stratified Percentage Difference|16.8||||0.0382|TWO_SIDED|95.0|2.0|31.6|||Cochran-Mantel-Haenszel|||CMH test was stratified by concomitant use of immunomodulators (Yes/No), at Maintenance baseline, and history of exposure to a biologic agent (Yes/No).||31.6|2.0|0.0382
72341398|NCT02914561|144206768|SUPERIORITY||Stratified Percentage Difference|5.8||||0.4263|TWO_SIDED|95.0|-8.5|20.0|||Cochran-Mantel-Haenszel|||CMH test was stratified by concomitant use of immunomodulators (Yes/No), at Maintenance baseline, and history of exposure to a biologic agent (Yes/No).||20.0|-8.5|0.4263
72341399|NCT02914561|144206769|SUPERIORITY||Stratified Percentage Difference|10.9||||0.1827|TWO_SIDED|95.0|-4.7|26.4|||Cochran-Mantel-Haenszel|||CMH test was stratified by concomitant use of immunomodulators (Yes/No) at Maintenance baseline, and history of exposure to a biologic agent (Yes/No).||26.4|-4.7|0.1827
72341400|NCT02914561|144206769|SUPERIORITY||Stratified Percentage Difference|4.0||||0.5944|TWO_SIDED|95.0|-11.1|19.2|||Cochran-Mantel-Haenszel|||CMH test was stratified by concomitant use of immunomodulators (Yes/No) at Maintenance baseline, and history of exposure to a biologic agent (Yes/No).||19.2|-11.1|0.5944
72341401|NCT02914561|144206770|SUPERIORITY||Stratified Percentage Difference|15.2||||0.0512|TWO_SIDED|95.0|1.0|29.3|||Cochran-Mantel-Haenszel|||CMH test was stratified by concomitant use of immunomodulators (Yes/No) at Maintenance baseline, and history of exposure to a biologic agent (Yes/No).||29.3|1.0|0.0512
72341402|NCT02914561|144206770|SUPERIORITY||Stratified Percentage Difference|-0.2||||0.9801|TWO_SIDED|95.0|-13.3|13.0|||Cochran-Mantel-Haenszel|||CMH test was stratified by concomitant use of immunomodulators (Yes/No) at Maintenance baseline, and history of exposure to a biologic agent (Yes/No).||13.0|-13.3|0.9801
72341403|NCT02914561|144206771|SUPERIORITY||Stratified Percentage Difference|14.0||||0.19|TWO_SIDED|95.0|-5.1|33.1|||Cochran-Mantel-Haenszel|||CMH test was stratified by immunomodulators (Yes) at Maintenance baseline, immunomodulators (No) at Maintenance baseline and history of exposure to biologic agent (Yes), and immunomodulators (No) at Maintenance baseline and history of exposure to biologic agent (No).||33.1|-5.1|0.1900
72341404|NCT02914561|144206771|SUPERIORITY||Stratified Percentage Difference|-5.5||||0.4248|TWO_SIDED|95.0|-22.6|11.6|||Cochran-Mantel-Haenszel|||CMH test was stratified by immunomodulators (Yes) at Maintenance baseline, immunomodulators (No) at Maintenance baseline and history of exposure to biologic agent (Yes), and immunomodulators (No) at Maintenance baseline and history of exposure to biologic agent (No).||11.6|-22.6|0.4248
72341405|NCT02914561|144206772|SUPERIORITY||Stratified Percentage Difference|19.9||||0.0122|TWO_SIDED|95.0|5.7|34.0|||Cochran-Mantel-Haenszel|||CMH test was stratified by concomitant use immunomodulators (Yes/No), at Maintenance baseline, and history of exposure to a biologic agent (Yes/No).||34.0|5.7|0.0122
72341406|NCT02914561|144206772|SUPERIORITY||Stratified Percentage Difference|2.0||||0.7708|TWO_SIDED|95.0|-12.0|16.1|||Cochran-Mantel-Haenszel|||CMH test was stratified by concomitant use immunomodulators (Yes/No), at Maintenance baseline, and history of exposure to a biologic agent (Yes/No).||16.1|-12.0|0.7708
72341407|NCT02914561|144206773|SUPERIORITY||Stratified Percentage Difference|12.0||||0.2631|TWO_SIDED|95.0|-8.3|32.3|||Cochran-Mantel-Haenszel|||CMH test was stratified by immunomodulators (Yes) at Maintenance baseline, immunomodulators (No) at Maintenance baseline and history of exposure to biologic agent (Yes), and immunomodulators (No) at Maintenance baseline and history of exposure to biologic agent (No).||32.3|-8.3|0.2631
72341408|NCT02914561|144206773|SUPERIORITY||Stratified Percentage Difference|-3.4||||0.6444|TWO_SIDED|95.0|-20.9|14.0|||Cochran-Mantel-Haenszel|||CMH test was stratified by immunomodulators (Yes) at Maintenance baseline, immunomodulators (No) at Maintenance baseline and history of exposure to biologic agent (Yes), and immunomodulators (No) at Maintenance baseline and history of exposure to biologic agent (No).||14.0|-20.9|0.6444
72341409|NCT03869333|144206846|OTHER|||||||0.504|||||||Kruskal-Wallis|||Kruskal-Wallis test of any difference between the 3 active dose groups in GMT at Baseline||||0.504
72341410|NCT03869333|144206846|OTHER|||||||0.01|||||||Kruskal-Wallis|||Kruskal-Wallis test of any difference between the 3 active dose groups in GMT at Day 22||||0.010
72341411|NCT03869333|144206846|OTHER|||||||0.038|||||||Kruskal-Wallis|||Kruskal-Wallis test of any difference between the 3 active dose groups in GMT at Day 43||||0.038
72341412|NCT03869333|144206846|OTHER|||||||0.016|||||||Kruskal-Wallis|||Kruskal-Wallis test of any difference between the 3 active dose groups in GMT at Day 50||||0.016
72341413|NCT03869333|144206846|OTHER|||||||0.058|||||||Kruskal-Wallis|||Kruskal-Wallis test of any difference between the 3 active dose groups in GMT at Day 57||||0.058
72341414|NCT03869333|144206846|OTHER|||||||0.038|||||||Kruskal-Wallis|||Kruskal-Wallis test of any difference between the 3 active dose groups in GMT at Day 71||||0.038
72341415|NCT03869333|144206847|OTHER|||||||0.129|||||||Kruskal-Wallis|||Kruskal-Wallis test of any difference between the 3 active dose groups in GMT at Baseline||||0.129
72341416|NCT03869333|144206847|OTHER|||||||0.017|||||||Kruskal-Wallis|||Kruskal-Wallis test of any difference between the 3 active dose groups in GMT at Day 22||||0.017
72341417|NCT03869333|144206847|OTHER|||||||0.008|||||||Kruskal-Wallis|||Kruskal-Wallis test of any difference between the 3 active dose groups in GMT at Day 43||||0.008
72341418|NCT03869333|144206847|OTHER|||||||0.011|||||||Kruskal-Wallis|||Kruskal-Wallis test of any difference between the 3 active dose groups in GMT at Day 50||||0.011
72341419|NCT03869333|144206847|OTHER|||||||0.029|||||||Kruskal-Wallis|||Kruskal-Wallis test of any difference between the 3 active dose groups in GMT at Day 57||||0.029
72341420|NCT03869333|144206847|OTHER|||||||0.042|||||||Kruskal-Wallis|||Kruskal-Wallis test of any difference between the 3 active dose groups in GMT at Day 71||||0.042
72341421|NCT03869333|144206848|OTHER|||||||0.226|||||||Kruskal-Wallis|||Kruskal-Wallis test of any difference between the 3 active dose groups in GMT at Baseline||||0.226
72341422|NCT03869333|144206848|OTHER|||||||0.601|||||||Kruskal-Wallis|||Kruskal-Wallis test of any difference between the 3 active dose groups in GMT at Day 8||||0.601
72341423|NCT03869333|144206848|OTHER|||||||0.628|||||||Kruskal-Wallis|||Kruskal-Wallis test of any difference between the 3 active dose groups in GMT at Day 29||||0.628
72341424|NCT03869333|144206848|OTHER|||||||0.878|||||||Kruskal-Wallis|||Kruskal-Wallis test of any difference between the 3 active dose groups in GMT at Day 50||||0.878
72341425|NCT03869333|144206849|OTHER|||||||0.762|||||||Kruskal-Wallis|||Kruskal-Wallis test of any difference between the 3 active dose groups in GMT at Baseline||||0.762
72341426|NCT03869333|144206849|OTHER|||||||0.335|||||||Kruskal-Wallis|||Kruskal-Wallis test of any difference between the 3 active dose groups in GMT at Day 8||||0.335
72341427|NCT03869333|144206849|OTHER|||||||0.229|||||||Kruskal-Wallis|||Kruskal-Wallis test of any difference between the 3 active dose groups in GMT at Day 29||||0.229
72341428|NCT03869333|144206849|OTHER|||||||0.102|||||||Kruskal-Wallis|||Kruskal-Wallis test of any difference between the 3 active dose groups in GMT at Day 50||||0.102
72341429|NCT03869333|144206850|OTHER|||||||0.828|||||||Fisher Exact|||Fisher's exact 2-tail test of the difference between the 3 Invaplex\[AR-Detox\] dose groups in seroconversion rates at Day 22.||||0.828
72341430|NCT03869333|144206850|OTHER|||||||0.629|||||||Fisher Exact|||Fisher's exact 2-tail test of the difference between the 3 Invaplex\[AR-Detox\] dose groups in seroconversion rates at Day 43||||0.629
72341431|NCT03869333|144206850|OTHER||||||>|0.999|||||||Fisher Exact|||Fisher's exact 2-tail test of the difference between the 3 Invaplex\[AR-Detox\] dose groups in seroconversion rates at Day 50||||>0.999
72341432|NCT03869333|144206850|OTHER||||||>|0.999|||||||Fisher Exact|||Fisher's exact 2-tail test of the difference between the 3 Invaplex\[AR-Detox\] dose groups in seroconversion rates at Day 57||||>0.999
72341433|NCT03869333|144206850|OTHER|||||||0.825|||||||Fisher Exact|||Fisher's exact 2-tail test of the difference between the 3 Invaplex\[AR-Detox\] dose groups in seroconversion rates at Day 71||||0.825
72341434|NCT03869333|144206851|OTHER|||||||0.005|||||||Fisher Exact|||Fisher's exact 2-tail test of the difference between the 3 Invaplex\[AR-Detox\] dose groups in seroconversion rates at Day 22.||||0.005
72341435|NCT03869333|144206851|OTHER|||||||0.082|||||||Fisher Exact|||Fisher's exact 2-tail test of the difference between the 3 Invaplex\[AR-Detox\] dose groups in seroconversion rates at Day 43||||0.082
72341436|NCT03869333|144206851|OTHER|||||||0.293|||||||Fisher Exact|||Fisher's exact 2-tail test of the difference between the 3 Invaplex\[AR-Detox\] dose groups in seroconversion rates at Day 50||||0.293
72341437|NCT03869333|144206851|OTHER||||||>|0.999|||||||Fisher Exact|||Fisher's exact 2-tail test of the difference between the 3 Invaplex\[AR-Detox\] dose groups in seroconversion rates at Day 57||||>0.999
72341438|NCT03869333|144206851|OTHER||||||>|0.999|||||||Fisher Exact|||Fisher's exact 2-tail test of the difference between the 3 Invaplex\[AR-Detox\] dose groups in seroconversion rates at Day 71||||>0.999
72341439|NCT03869333|144206852|OTHER|||||||0.828|||||||Fisher Exact|||Fisher's exact 2-tail tests of differences between the 3 Invaplex\[AR-Detox\] dose groups in seroconversion rates at Day 8||||0.828
72341440|NCT03869333|144206852|OTHER|||||||0.913|||||||Fisher Exact|||Fisher's exact 2-tail tests of differences between the 3 Invaplex\[AR-Detox\] dose groups in seroconversion rates at Day 29||||0.913
72341441|NCT03869333|144206852|OTHER|||||||0.924|||||||Fisher Exact|||Fisher's exact 2-tail tests of differences between the 3 Invaplex\[AR-Detox\] dose groups in seroconversion rates at Day 50||||0.924
72341442|NCT03869333|144206853|OTHER||||||>|0.999|||||||Fisher Exact|||Fisher's exact 2-tail tests of differences between the 3 Invaplex\[AR-Detox\] dose groups in seroconversion rates at Day 8||||>0.999
72341443|NCT03869333|144206853|OTHER|||||||0.412|||||||Fisher Exact|||Fisher's exact 2-tail tests of differences between the 3 Invaplex\[AR-Detox\] dose groups in seroconversion rates at Day 29||||0.412
72341444|NCT03869333|144206853|OTHER|||||||0.847|||||||Fisher Exact|||Fisher's exact 2-tail tests of differences between the 3 Invaplex\[AR-Detox\] dose groups in seroconversion rates at Day 50||||0.847
72341445|NCT03869333|144206854|OTHER|||||||0.009|||||||Kruskal-Wallis|||Kruskal-Wallis test of any difference between the 3 active dose groups in GMFR at Day 22||||0.009
72341446|NCT03869333|144206854|OTHER|||||||0.037|||||||Kruskal-Wallis|||Kruskal-Wallis test of any difference between the 3 active dose groups in GMFR at Day 43||||0.037
72341447|NCT03869333|144206854|OTHER|||||||0.009|||||||Kruskal-Wallis|||Kruskal-Wallis test of any difference between the 3 active dose groups in GMFR at Day 50||||0.009
72341448|NCT03869333|144206854|OTHER|||||||0.036|||||||Kruskal-Wallis|||Kruskal-Wallis test of any difference between the 3 active dose groups in GMFR at Day 57||||0.036
72341449|NCT03869333|144206854|OTHER|||||||0.042|||||||Kruskal-Wallis|||Kruskal-Wallis test of any difference between the 3 active dose groups in GMFR at Day 71||||0.042
72341450|NCT03869333|144206855|OTHER|||||||0.028|||||||Kruskal-Wallis|||Kruskal-Wallis test of any difference between the 3 active dose groups in GMFR at Day 22||||0.028
72341451|NCT03869333|144206855|OTHER|||||||0.088|||||||Kruskal-Wallis|||Kruskal-Wallis test of any difference between the 3 active dose groups in GMFR at Day 43||||0.088
72341452|NCT03869333|144206855|OTHER|||||||0.146|||||||Kruskal-Wallis|||Kruskal-Wallis test of any difference between the 3 active dose groups in GMFR at Day 50||||0.146
72341453|NCT03869333|144206855|OTHER|||||||0.126|||||||Kruskal-Wallis|||Kruskal-Wallis test of any difference between the 3 active dose groups in GMFR at Day 57||||0.126
72341454|NCT03869333|144206855|OTHER|||||||0.273|||||||Kruskal-Wallis|||Kruskal-Wallis test of any difference between the 3 active dose groups in GMFR at Day 71||||0.273
72341455|NCT03869333|144206857|OTHER|||||||0.348|||||||Kruskal-Wallis|||Kruskal-Wallis test of any difference between the 3 active dose groups in GMFR at Day 8||||0.348
72341456|NCT03869333|144206857|OTHER|||||||0.179|||||||Kruskal-Wallis|||Kruskal-Wallis test of any difference between the 3 active dose groups in GMFR at Day 29||||0.179
72341457|NCT03869333|144206857|OTHER|||||||0.089|||||||Kruskal-Wallis|||Kruskal-Wallis test of any difference between the 3 active dose groups in GMFR at Day 50||||0.089
72341458|NCT02598128|144206860|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Mixed Models Analysis|The independent variables in the mixed model analysis included fixed effect factors for treatment (placebo or RELiZORB).||||||<0.001
72341459|NCT01064687|144206879|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.05|||<|0.001|TWO_SIDED|95.0|-1.22|-0.88||P-value is adjusted for multiplicity based on a tree-gatekeeping strategy. To determine significance, p-value is compared to the family-wise 1-sided Type I error of 0.025. The confidence interval is not adjusted for multiplicity.|ANCOVA|||Superiority analysis.||-0.88|-1.22|<0.001
72341460|NCT01064687|144206879|NON_INFERIORITY_OR_EQUIVALENCE|A non-inferiority margin of 0.4% was used.|LS Mean Difference|-0.52|||<|0.0001|TWO_SIDED|95.0|-0.66|-0.39||P-value is adjusted for multiplicity, based on tree-gatekeeping strategy. To determine significance, p-value is compared to the family-wise 1-sided Type I error of 0.025. The confidence interval is not adjusted for multiplicity.|ANCOVA|||Non-inferiority analysis.||-0.39|-0.66|<0.0001
72341461|NCT01064687|144206879|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.84|||<|0.001|TWO_SIDED|95.0|-1.01|-0.67||P-value is adjusted for multiplicity based on a tree-gatekeeping strategy. To determine significance, p-value is compared to the family-wise 1-sided Type I error of 0.025. The confidence interval is not adjusted for multiplicity.|ANCOVA|||Superiority analysis.||-0.67|-1.01|<0.001
72341462|NCT01064687|144206879|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.52|||<|0.001|TWO_SIDED|95.0|-0.66|-0.39||P-value is adjusted for multiplicity based on a tree-gatekeeping strategy. To determine significance, p-value is compared to the family-wise 1-sided Type I error of 0.025. The confidence interval is not adjusted for multiplicity.|ANCOVA|||Superiority analysis.||-0.39|-0.66|<0.001
72341463|NCT01064687|144206879|NON_INFERIORITY_OR_EQUIVALENCE|A non-inferiority margin of 0.4% was used.|LS Mean Difference|-0.31|||<|0.001|TWO_SIDED|95.0|-0.44|-0.18||P-value is adjusted for multiplicity, based on tree-gatekeeping strategy. To determine significance, p-value is compared to the family-wise 1-sided Type I error of 0.025. The confidence interval is not adjusted for multiplicity.|ANCOVA|||Non-inferiority analysis.||-0.18|-0.44|<0.001
72341464|NCT01064687|144206879|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.31|||<|0.001|TWO_SIDED|95.0|-0.44|-0.18||P-value is adjusted for multiplicity based on a tree-gatekeeping strategy. To determine significance, p-value is compared to the family-wise 1-sided Type I error of 0.025. The confidence interval is not adjusted for multiplicity.|ANCOVA|||Superiority analysis.||-0.18|-0.44|<0.001
72341465|NCT01064687|144206880|NON_INFERIORITY_OR_EQUIVALENCE|A non-inferiority margin of 0.4% was used.|LS Mean Difference|-0.56|||<|0.001|TWO_SIDED|95.0|-0.73|-0.39||P-value is adjusted for multiplicity, based on tree-gatekeeping strategy. To determine significance, p-value is compared to the family-wise 1-sided Type I error of 0.025. The confidence interval is not adjusted for multiplicity.|ANCOVA|||Non-inferiority analysis.||-0.39|-0.73|<0.001
72341466|NCT01064687|144206880|NON_INFERIORITY_OR_EQUIVALENCE|A non-inferiority margin of 0.4% was used.|LS Mean Difference|-0.27|||<|0.001|TWO_SIDED|95.0|-0.44|-0.11||P-value is adjusted for multiplicity, based on tree-gatekeeping strategy. To determine significance, p-value is compared to the family-wise 1-sided Type I error of 0.025. The confidence interval is not adjusted for multiplicity.|ANCOVA|||Non-inferiority analysis.||-0.11|-0.44|<0.001
72341467|NCT01064687|144206880|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.56|||<|0.001|TWO_SIDED|95.0|-0.73|-0.39||P-value is adjusted for multiplicity based on a tree-gatekeeping strategy. To determine significance, p-value is compared to the family-wise 1-sided Type I error of 0.025. The confidence interval is not adjusted for multiplicity.|ANCOVA|||Superiority analysis.||-0.39|-0.73|<0.001
72341468|NCT01064687|144206880|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.27|||<|0.001|TWO_SIDED|95.0|-0.44|-0.11||P-value is adjusted for multiplicity, based on tree-gatekeeping strategy. To determine significance, p-value is compared to the family-wise 1-sided Type I error of 0.025. The confidence interval is not adjusted for multiplicity.|ANCOVA|||Superiority analysis.||-0.11|-0.44|<0.001
72428470|NCT00432679|144367895|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|8.21|STANDARD_ERROR_OF_MEAN|0.86|<|0.001|TWO_SIDED|95.0|6.52|9.91|||Unpaired t-test|||||9.91|6.52|<0.001
72341469|NCT01064687|144206881|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.72|||<|0.001|TWO_SIDED|95.0|-3.58|-1.85|||Mixed Models Analysis|||||-1.85|-3.58|<0.001
72341470|NCT01064687|144206881|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2||||0.571|TWO_SIDED|95.0|-0.88|0.49|||Mixed Models Analysis|||||0.49|-0.88|0.571
72341471|NCT01064687|144206881|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.19||||0.007|TWO_SIDED|95.0|-2.06|-0.33|||Mixed Models Analysis|||||-0.33|-2.06|0.007
72341472|NCT01064687|144206881|SUPERIORITY_OR_OTHER||LS Mean Difference|1.33|||<|0.001|TWO_SIDED|95.0|0.64|2.01|||Mixed Models Analysis|||||2.01|0.64|<0.001
72341473|NCT01064687|144206881|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.52|||<|0.001|TWO_SIDED|95.0|-3.39|-1.65|||Mixed Models Analysis|||||-1.65|-3.39|<0.001
72341474|NCT01064687|144206882|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.32||||0.507|TWO_SIDED|95.0|-1.25|0.62|||Mixed Models Analysis|||||0.62|-1.25|0.507
72341475|NCT01064687|144206882|SUPERIORITY_OR_OTHER||LS Mean Difference|1.25||||0.009|TWO_SIDED|95.0|0.32|2.19|||Mixed Models Analysis|||||2.19|0.32|0.009
72341476|NCT01064687|144206883|SUPERIORITY_OR_OTHER||LS Means Difference|-0.97|||<|0.001|TWO_SIDED|95.0|-1.27|-0.67|||Mixed Models Analysis|||||-0.67|-1.27|<0.001
72341477|NCT01064687|144206883|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.07||||0.568|TWO_SIDED|95.0|-0.31|0.17|||Mixed Models Analysis|||||0.17|-0.31|0.568
72341478|NCT01064687|144206883|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.42||||0.006|TWO_SIDED|95.0|-0.72|-0.12|||Mixed Models Analysis|||||-0.12|-0.72|0.006
72428471|NCT00432679|144367896|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.65|STANDARD_ERROR_OF_MEAN|0.355||0.069|TWO_SIDED|95.0|-0.05|1.35|||Unpaired t-test||Comparison of leptin.|||1.35|-0.05|0.069
72341479|NCT01064687|144206883|SUPERIORITY_OR_OTHER||LS Mean Difference|0.48|||<|0.001|TWO_SIDED|95.0|0.24|0.71|||Mixed Models Analysis|||||0.71|0.24|<0.001
72341480|NCT01064687|144206883|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.9|||<|0.001|TWO_SIDED|95.0|-1.2|-0.6|||Mixed Models Analysis|||||-0.60|-1.20|<0.001
72341481|NCT01064687|144206884|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.09||||0.58|TWO_SIDED|95.0|-0.42|0.23|||Mixed Models Analysis|||||0.23|-0.42|0.580
72341482|NCT01064687|144206884|SUPERIORITY_OR_OTHER||LS Mean Difference|0.46||||0.005|TWO_SIDED|95.0|0.14|0.79|||Mixed Models Analysis|||||0.79|0.14|0.005
72341483|NCT01064687|144206885|SUPERIORITY_OR_OTHER||LS Mean Difference|-28.76|||<|0.001|TWO_SIDED|95.0|-34.5|-23.02|||Mixed Models Analysis|||||-23.02|-34.50|<0.001
72341484|NCT01064687|144206885|SUPERIORITY_OR_OTHER||LS Mean Difference|-9.34|||<|0.001|TWO_SIDED|95.0|-13.62|-5.06|||Mixed Models Analysis|||||-5.06|-13.62|<0.001
72341485|NCT01064687|144206885|SUPERIORITY_OR_OTHER||LS Mean Difference|-24.02|||<|0.001|TWO_SIDED|95.0|-29.8|-18.24|||Mixed Models Analysis|||||-18.24|-29.80|<0.001
72341486|NCT01064687|144206885|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.61||||0.038|TWO_SIDED|95.0|-8.95|-0.27|||Mixed Models Analysis|||||-0.27|-8.95|0.038
72341487|NCT01064687|144206885|SUPERIORITY_OR_OTHER||LS Mean Difference|-19.41|||<|0.001|TWO_SIDED|95.0|-25.18|-13.65|||Mixed Models Analysis|||||-13.65|-25.18|<0.001
72341488|NCT01064687|144206886|SUPERIORITY_OR_OTHER||LS Mean Difference|-7.68||||0.004|TWO_SIDED|95.0|-12.84|-2.52|||Mixed Models Analysis|||||-2.52|-12.84|0.004
72341489|NCT01064687|144206886|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.47||||0.092|TWO_SIDED|95.0|-9.66|0.73|||Mixed Models Analysis|||||0.73|-9.66|0.092
72341490|NCT01064687|144206887|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|13.1|||<|0.001|TWO_SIDED|95.0|7.4|23.4||Treatment comparison for HbA1c less than 7.0%.|Regression, Logistic|||||23.4|7.4|<0.001
72341491|NCT01064687|144206887|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.2|||<|0.001|TWO_SIDED|95.0|3.9|10.1||Treatment comparison for HbA1c less than 7.0%.|Regression, Logistic|||||10.1|3.9|<0.001
72341492|NCT01064687|144206887|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.8|||<|0.001|TWO_SIDED|95.0|2.8|8.0||Treatment comparison for HbA1c less than 7.0%.|Regression, Logistic|||||8.0|2.8|<0.001
72341493|NCT01064687|144206887|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.3|||<|0.001|TWO_SIDED|95.0|1.5|3.5||Treatment comparison for HbA1c less than 7.0%.|Regression, Logistic|||||3.5|1.5|<0.001
72341494|NCT01064687|144206887|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.1||||0.004|TWO_SIDED|95.0|1.3|3.5||Treatment comparison for HbA1c less than 7.0%.|Regression, Logistic|||||3.5|1.3|0.004
72341495|NCT01064687|144206887|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|11.8|||<|0.001|TWO_SIDED|95.0|6.7|20.8||Treatment comparison for HbA1c less than or equal to 6.5%.|Regression, Logistic|||||20.8|6.7|<0.001
72341496|NCT01064687|144206887|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.4|||<|0.001|TWO_SIDED|95.0|2.9|6.8||Treatment comparison for HbA1c less than or equal to 6.5%.|Regression, Logistic|||||6.8|2.9|<0.001
72341497|NCT01064687|144206887|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.3|||<|0.001|TWO_SIDED|95.0|3.7|10.9||Treatment comparison for HbA1c less than or equal to 6.5%.|Regression, Logistic|||||10.9|3.7|<0.001
72341498|NCT01064687|144206887|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.4|||<|0.001|TWO_SIDED|95.0|1.6|3.5||Treatment comparison for HbA1c less than or equal to 6.5%.|Regression, Logistic|||||3.5|1.6|<0.001
72341499|NCT01064687|144206887|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.7|||<|0.001|TWO_SIDED|95.0|1.6|4.6||Treatment comparison for HbA1c less than or equal to 6.5%.|Regression, Logistic|||||4.6|1.6|<0.001
72428472|NCT00432679|144367896|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-888.8|STANDARD_ERROR_OF_MEAN|803.96||0.271|TWO_SIDED|95.0|-2477.7|700.1|||Unpaired t-test||Comparison of hs-CRP|||700.1|-2477.7|0.271
72428473|NCT00432679|144367897|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|40.6|||||TWO_SIDED|95.0|27.1|54.1|||||Comparison of HbA1c, decrease by 0.7%|||54.1|27.1|
72428474|NCT00432679|144367897|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|6.8|||||TWO_SIDED|95.0|-0.3|13.8|||||Comparison of HbA1c, fell below 6.5%|||13.8|-0.3|
72341500|NCT01064687|144206888|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.7|||<|0.001|TWO_SIDED|95.0|2.4|5.6||Treatment comparison for HbA1c less than 7.0%.|Regression, Logistic|||||5.6|2.4|<0.001
72341501|NCT01064687|144206888|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.7||||0.008|TWO_SIDED|95.0|1.1|2.5||Treatment comparison for HbA1c less than 7.0%.|Regression, Logistic|||||2.5|1.1|0.008
72428475|NCT00432679|144367897|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|40.6|||||TWO_SIDED|95.0|27.1|54.1|||||Comparison of HbA1c, satisfied either 1 or 2|||54.1|27.1|
72341502|NCT01064687|144206888|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.5|||<|0.001|TWO_SIDED|95.0|2.3|5.1||Treatment comparison for HbA1c less than or equal to 6.5%.|Regression, Logistic|||||5.1|2.3|<0.001
72341503|NCT01064687|144206888|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.1|||<|0.001|TWO_SIDED|95.0|1.4|3.1||Treatment comparison for HbA1c less than or equal to 6.5%.|Regression, Logistic|||||3.1|1.4|<0.001
72341504|NCT01064687|144206889|SUPERIORITY_OR_OTHER||LS Mean Difference|35.21|||<|0.001|TWO_SIDED|95.0|27.26|43.16||Treatment comparison of HOMA2-B|Mixed Models Analysis|||||43.16|27.26|<0.001
72341505|NCT01064687|144206889|SUPERIORITY_OR_OTHER||LS Mean Difference|21.12|||<|0.001|TWO_SIDED|95.0|14.97|27.28||Treatment comparison of HOMA2-B|Mixed Models Analysis|||||27.28|14.97|<0.001
72341506|NCT01064687|144206889|SUPERIORITY_OR_OTHER||LS Mean Difference|22.68|||<|0.001|TWO_SIDED|95.0|14.63|30.72||Treatment comparison of HOMA2-B|Mixed Models Analysis|||||30.72|14.63|<0.001
72341507|NCT01064687|144206889|SUPERIORITY_OR_OTHER||LS Mean Difference|8.59||||0.007|TWO_SIDED|95.0|2.31|14.87||Treatment comparison of HOMA2-B|Mixed Models Analysis|||||14.87|2.31|0.007
72341508|NCT01064687|144206889|SUPERIORITY_OR_OTHER||LS Mean Difference|14.09|||<|0.001|TWO_SIDED|95.0|6.06|22.11||Treatment comparison of HOMA2-B|Mixed Models Analysis|||||22.11|6.06|<0.001
72341509|NCT01064687|144206889|SUPERIORITY_OR_OTHER||LS Mean Difference|-5.7||||0.207|TWO_SIDED|95.0|-14.56|3.17||Treatment comparison of HOMA2-S|Mixed Models Analysis|||||3.17|-14.56|0.207
72341510|NCT01064687|144206889|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.54||||0.659|TWO_SIDED|95.0|-8.41|5.32||Treatment comparison of HOMA2-S|Mixed Models Analysis|||||5.32|-8.41|0.659
72341511|NCT01064687|144206889|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.4||||0.759|TWO_SIDED|95.0|-10.37|7.56||Treatment comparison of HOMA2-S|Mixed Models Analysis|||||7.56|-10.37|0.759
72341512|NCT01064687|144206889|SUPERIORITY_OR_OTHER||LS Mean Difference|2.75||||0.441|TWO_SIDED|95.0|-4.25|9.76||Treatment comparison of HOMA2-S|Mixed Models Analysis|||||9.76|-4.25|0.441
72341513|NCT01064687|144206889|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.15||||0.362|TWO_SIDED|95.0|-13.1|4.79||Treatment comparison of HOMA2-S|Mixed Models Analysis|||||4.79|-13.10|0.362
72341514|NCT01064687|144206890|SUPERIORITY_OR_OTHER||LS Mean Difference|21.64|||<|0.001|TWO_SIDED|95.0|15.2|28.08||Treatment comparison of HOMA2-B|Mixed Models Analysis|||||28.08|15.20|<0.001
72341515|NCT01064687|144206890|SUPERIORITY_OR_OTHER||LS Mean Difference|12.12|||<|0.001|TWO_SIDED|95.0|5.56|18.68||Treatment comparison of HOMA2-B|Mixed Models Analysis|||||18.68|5.56|<0.001
72341516|NCT01064687|144206890|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.73||||0.307|TWO_SIDED|95.0|-10.9|3.43||Treatment comparison of HOMA2-S|Mixed Models Analysis|||||3.43|-10.90|0.307
72341517|NCT01064687|144206890|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.75||||0.638|TWO_SIDED|95.0|-9.05|5.55||Treatment comparison of HOMA2-S|Mixed Models Analysis|||||5.55|-9.05|0.638
72341518|NCT01969721|144206933|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.125|STANDARD_ERROR_OF_MEAN|0.011|<|0.0001|TWO_SIDED|95.0|0.103|0.147||p-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is two-sided alpha=0.05.|Mixed Models Analysis|Compound symmetry covariance structure for within-patient variation and Kenward-Roger approximation of denominator degrees of freedom.|Difference calculated as T+O 5/5 - F+S 250/50 adjusted mean FEV1 AUC 0-12h change from patient baseline (L)|"Null hypothesis: Mean FEV1 AUC 0-12h change from patient baseline (Tiotropium + Olodaterol 5/5 µg) = Mean FEV1 AUC 0-12h change from patient baseline (Fluticasone propionate + Salmeterol 250/50 µg).~Hypothesis was analysed using a restricted maximum likelihood-based mixed effect repeated measures model including fixed effects of treatment and period; period baseline and patient baseline as covariates; patient as a random effect."||0.147|0.103|<0.0001
72341519|NCT01969721|144206933|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.129|STANDARD_ERROR_OF_MEAN|0.011|<|0.0001|TWO_SIDED|95.0|0.107|0.15||p-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is two-sided alpha=0.05.|Mixed Models Analysis|Compound symmetry covariance structure for within-patient variation and Kenward-Roger approximation of denominator degrees of freedom.|Difference calculated as T+O 5/5 - F+S 500/50 adjusted mean FEV1 AUC 0-12h change from patient baseline (L)|"Null hypothesis: Mean FEV1 AUC 0-12h change from patient baseline (Tiotropium + Olodaterol 5/5 µg) = Mean FEV1 AUC 0-12h change from patient baseline (Fluticasone propionate + Salmeterol 500/50 µg).~Hypothesis was analysed using a restricted maximum likelihood-based mixed effect repeated measures model including fixed effects of treatment and period; period baseline and patient baseline as covariates; patient as a random effect."||0.150|0.107|<0.0001
72341520|NCT01969721|144206933|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.103|STANDARD_ERROR_OF_MEAN|0.011|<|0.0001||95.0|0.081|0.124||p-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is two-sided alpha=0.05.|Mixed Models Analysis|Compound symmetry covariance structure for within-patient variation and Kenward-Roger approximation of denominator degrees of freedom.|Difference calculated as T+O 2.5/5 - F+S 250/50 adjusted mean FEV1 AUC 0-12h change from patient baseline (L)|"Null hypothesis: Mean FEV1 AUC 0-12h change from patient baseline (Tiotropium + Olodaterol 2.5/5 µg) = Mean FEV1 AUC 0-12h change from patient baseline (Fluticasone propionate + Salmeterol 250/50 µg).~Hypothesis was analysed using a restricted maximum likelihood-based mixed effect repeated measures model including fixed effects of treatment and period; period baseline and patient baseline as covariates; patient as a random effect."||0.124|0.081|<0.0001
72341521|NCT01969721|144206933|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.106|STANDARD_ERROR_OF_MEAN|0.011|<|0.0001|TWO_SIDED|95.0|0.085|0.128||p-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is two-sided alpha=0.05.|Mixed Models Analysis|Compound symmetry covariance structure for within-patient variation and Kenward-Roger approximation of denominator degrees of freedom.|Difference calculated as T+O 2.5/5 - F+S 500/50 adjusted mean FEV1 AUC 0-12h change from patient baseline (L)|"Null hypothesis: Mean FEV1 AUC 0-12h change from patient baseline (Tiotropium + Olodaterol 2.5/5 µg) = Mean FEV1 AUC 0-12h change from patient baseline (Fluticasone propionate + Salmeterol 500/50 µg).~Hypothesis was analysed using a restricted maximum likelihood-based mixed effect repeated measures model including fixed effects of treatment and period; period baseline and patient baseline as covariates; patient as a random effect."||0.128|0.085|<0.0001
72428476|NCT00432679|144367897|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|23.1|||||TWO_SIDED|95.0|9.5|36.6|||||Comparison of FPG, decrease of 30 milligrams per decilliter|||36.6|9.5|
72428477|NCT00432679|144367897|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|6.9|||||TWO_SIDED|95.0|-5.1|18.9|||||Comparison of FPG, fell below 126 milligrams per deciliter|||18.9|-5.1|
72341522|NCT01969721|144206934|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.082|STANDARD_ERROR_OF_MEAN|0.011|<|0.0001|TWO_SIDED|95.0|0.061|0.103||p-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is two-sided alpha=0.05.|Mixed Models Analysis|Compound symmetry covariance structure for within-patient variation and Kenward-Roger approximation of denominator degrees of freedom.|Difference calculated as T+O 5/5 - F+S 250/50 adjusted mean FEV1 AUC 0-24h change from patient baseline (L)|Null hypothesis: Mean FEV1 AUC 0-24h change from patient baseline (Tiotropium + Olodaterol 5/5 μg) = Mean FEV1 AUC 0-24h change from patient baseline (Fluticasone propionate + Salmeterol 250/50 μg). Hypothesis was analysed using a restricted maximum likelihood-based mixed effect repeated measures model including fixed effects of treatment and period; period baseline and patient baseline as covariates; patient as a random effect.||0.103|0.061|<0.0001
72341523|NCT01969721|144206934|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.086|STANDARD_ERROR_OF_MEAN|0.011|<|0.0001|TWO_SIDED|95.0|0.065|0.107||p-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is two-sided alpha=0.05.|Mixed Models Analysis|Compound symmetry covariance structure for within-patient variation and Kenward-Roger approximation of denominator degrees of freedom.|Difference calculated as T+O 5/5 - F+S 500/50 adjusted mean FEV1 AUC 0-24h change from patient baseline (L)|Null hypothesis: Mean FEV1 AUC 0-24h change from patient baseline (Tiotropium + Olodaterol 5/5 μg) = Mean FEV1 AUC 0-24h change from patient baseline (Fluticasone propionate + Salmeterol 500/50 μg). Hypothesis was analysed using a restricted maximum likelihood-based mixed effect repeated measures model including fixed effects of treatment and period; period baseline and patient baseline as covariates; patient as a random effect.||0.107|0.065|<0.0001
72341524|NCT01969721|144206934|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.065|STANDARD_ERROR_OF_MEAN|0.011|<|0.0001|TWO_SIDED|95.0|0.045|0.086||p-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is two-sided alpha=0.05.|Mixed Models Analysis|Compound symmetry covariance structure for within-patient variation and Kenward-Roger approximation of denominator degrees of freedom.|Difference calculated as T+O 2.5/5 - F+S 250/50 adjusted mean FEV1 AUC 0-24h change from patient baseline (L)|Null hypothesis: Mean FEV1 AUC 0-24h change from patient baseline (Tiotropium + Olodaterol 2.5/5 μg) = Mean FEV1 AUC 0-24h change from patient baseline (Fluticasone propionate + Salmeterol 250/50 μg). Hypothesis was analysed using a restricted maximum likelihood-based mixed effect repeated measures model including fixed effects of treatment and period; period baseline and patient baseline as covariates; patient as a random effect.||0.086|0.045|<0.0001
72341525|NCT01969721|144206934|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.069|STANDARD_ERROR_OF_MEAN|0.011|<|0.0001|TWO_SIDED|95.0|0.048|0.09||p-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is two-sided alpha=0.05.|Mixed Models Analysis|Compound symmetry covariance structure for within-patient variation and Kenward-Roger approximation of denominator degrees of freedom.|Difference calculated as T+O 2.5/5 - F+S 500/50 adjusted mean FEV1 AUC 0-24h change from patient baseline (L)|Null hypothesis: Mean FEV1 AUC 0-24h change from patient baseline (Tiotropium + Olodaterol 2.5/5 μg) = Mean FEV1 AUC 0-24h change from patient baseline (Fluticasone propionate + Salmeterol 500/50 μg). Hypothesis was analysed using a restricted maximum likelihood-based mixed effect repeated measures model including fixed effects of treatment and period; period baseline and patient baseline as covariates; patient as a random effect.||0.090|0.048|<0.0001
72341526|NCT01969721|144206935|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.047|STANDARD_ERROR_OF_MEAN|0.012||0.0002|TWO_SIDED|95.0|0.022|0.071||p-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is two-sided alpha=0.05.|Mixed Models Analysis|Compound symmetry covariance structure for within-patient variation and Kenward-Roger approximation of denominator degrees of freedom.|Difference calculated as T+O 5/5 - F+S 250/50 adjusted mean trough FEV1 change from patient baseline (L)|Null hypothesis: Mean trough FEV1 change from patient baseline (Tiotropium + Olodaterol 5/5 μg) = Mean trough FEV1 change from patient baseline (Fluticasone propionate + Salmeterol 250/50 μg). Hypothesis was analysed using a restricted maximum likelihood-based mixed effect repeated measures model including fixed effects of treatment and period; period baseline and patient baseline as covariates; patient as a random effect.||0.071|0.022|0.0002
72341527|NCT01969721|144206935|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.058|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|0.034|0.082||p-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is two-sided alpha=0.05.|Mixed Models Analysis|Compound symmetry covariance structure for within-patient variation and Kenward-Roger approximation of denominator degrees of freedom.|Difference calculated as T+O 5/5 - F+S 500/50 adjusted mean trough FEV1 change from patient baseline (L)|Null hypothesis: Mean trough FEV1 change from patient baseline (Tiotropium + Olodaterol 5/5 μg) = Mean trough FEV1 change from patient baseline (Fluticasone propionate + Salmeterol 500/50 μg). Hypothesis was analysed using a restricted maximum likelihood-based mixed effect repeated measures model including fixed effects of treatment and period; period baseline and patient baseline as covariates; patient as a random effect.||0.082|0.034|<0.0001
72341528|NCT01969721|144206935|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.042|STANDARD_ERROR_OF_MEAN|0.012||0.0007|TWO_SIDED|95.0|0.018|0.067||p-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is two-sided alpha=0.05.|Mixed Models Analysis|Compound symmetry covariance structure for within-patient variation and Kenward-Roger approximation of denominator degrees of freedom.|Difference calculated as T+O 2.5/5 - F+S 250/50 adjusted mean trough FEV1 change from patient baseline (L)|Null hypothesis: Mean trough FEV1 change from patient baseline (Tiotropium + Olodaterol 2.5/5 μg) = Mean trough FEV1 change from patient baseline (Fluticasone propionate + Salmeterol 250/50 μg). Hypothesis was analysed using a restricted maximum likelihood-based mixed effect repeated measures model including fixed effects of treatment and period; period baseline and patient baseline as covariates; patient as a random effect.||0.067|0.018|0.0007
72368379|NCT00298558|144246919|SUPERIORITY_OR_OTHER||Effect Size|-0.02||||0.69|TWO_SIDED|99.0|-0.17|0.12|||Mixed Models Analysis|The blom transformation was used to reduce skewness in the measures. The design factors and baseline covariates were controlled in the model.|Blom transformed outcome was used and the design factors and baseline covariates were controlled in the model to get the adjusted means. After that, the effect size (defined in the Additional details) was calculated using the adjusted means and SD.|Effect size was defined as training improvement from baseline to year 10 minus control improvement from baseline to year 10 divided by the intrasubject standard deviation (SD) of the composite score. Positive effect sizes indicate improvement.||0.12|-0.17|0.69
72428478|NCT00432679|144367897|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|20.5|||||TWO_SIDED|95.0|5.6|35.3|||||Comparison of FPG, satisfied either 1 or 2|||35.3|5.6|
72341529|NCT01969721|144206935|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.054|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|0.029|0.078||p-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is two-sided alpha=0.05.|Mixed Models Analysis|Compound symmetry covariance structure for within-patient variation and Kenward-Roger approximation of denominator degrees of freedom.|Difference calculated as T+O 2.5/5 - F+S 500/50 adjusted mean trough FEV1 change from patient baseline (L)|Null hypothesis: Mean trough FEV1 change from patient baseline (Tiotropium + Olodaterol 2.5/5 μg) = Mean trough FEV1 change from patient baseline (Fluticasone propionate + Salmeterol 500/50 μg). Hypothesis was analysed using a restricted maximum likelihood-based mixed effect repeated measures model including fixed effects of treatment and period; period baseline and patient baseline as covariates; patient as a random effect.||0.078|0.029|<0.0001
72370040|NCT02105961|144250541|SUPERIORITY||Rate ratio (Mepolizumab 300/Placebo)|0.86||||0.14|TWO_SIDED|95.0|0.7|1.05||Adjusted p-value; Family wise type I error controlled within each endpoint using a Hochberg testing procedure|Negative binomial model||Analysis using a negative binomial model with covariates of treatment, geographic region, no. of moderate/severe exacerbations in previous year, Baseline percent predicted FEV1, smoking status and offset of log (time in on- and off- treatment period|||1.05|0.70|0.140
72370041|NCT02105961|144250541|SUPERIORITY||Rate ratio (Mepolizumab 300/Placebo)|0.86||||0.14|TWO_SIDED|95.0|0.7|1.05||Unadjusted p-value|Negative binomial model||Analysis using a negative binomial model with covariates of treatment, geographic region, no. of moderate/severe exacerbations in previous year, Baseline percent predicted FEV1, smoking status and offset of log (time in on- and off- treatment period)|||1.05|0.70|0.140
72370042|NCT02105961|144250542|SUPERIORITY||Hazard Ratio(Mepolizumab 100/Placebo)|0.82||||0.14|TWO_SIDED|95.0|0.64|1.04||Adjusted p-value; Family wise type I error controlled within each endpoint using a Hochberg testing procedure|Cox Proportional Hazards Model||Analysis performed using a Cox Proportional Hazards Model with covariates of treatment, geographic region, number of moderate/severe exacerbations in previous year, Baseline percent predicted FEV1 and smoking status|||1.04|0.64|0.140
72370043|NCT02105961|144250542|SUPERIORITY||Hazard Ratio (Mepolizumab/Placebo)|0.82||||0.103|TWO_SIDED|95.0|0.64|1.04||Unadjusted p-value|Cox Proportional Hazards Model||Analysis performed using a Cox Proportional Hazards Model with covariates of treatment, geographic region, number of moderate/severe exacerbations in previous year, Baseline percent predicted FEV1 and smoking status|||1.04|0.64|0.103
72370044|NCT02105961|144250542|SUPERIORITY||Hazard Ratio (Mepolizumab 300/Placebo)|0.77||||0.14|TWO_SIDED|95.0|0.6|0.97||Adjusted p-value; Family wise type I error controlled within each endpoint using a Hochberg testing procedure|Cox Proportional Hazards Model||Analysis performed using a Cox Proportional Hazards Model with covariates of treatment, geographic region, number of moderate/severe exacerbations in previous year, Baseline percent predicted FEV1 and smoking status|||0.97|0.60|0.140
72370045|NCT02105961|144250542|SUPERIORITY||Hazard Ratio (Mepolizumab 300/Placebo)|0.77||||0.03|TWO_SIDED|95.0|0.6|0.97||Unadjusted p-value|Cox Proportional Hazards Model||Analysis performed using a Cox Proportional Hazards Model with covariates of treatment, geographic region, number of moderate/severe exacerbations in previous year, Baseline percent predicted FEV1 and smoking status|||0.97|0.60|0.030
72370046|NCT02105961|144250543|SUPERIORITY||Rate ratio (Mepolizumab 100/Placebo)|0.59||||0.14|TWO_SIDED|95.0|0.35|0.98||Adjusted p-value; Family wise type I error controlled within each endpoint using a Hochberg testing procedure|Negative binomial model||Analysis using a negative binomial model with covariates of treatment, geographic region, no. of moderate/severe exacerbations in previous year, Baseline percent predicted FEV1, smoking status and offset of log (time in on- and off- treatment period)|||0.98|0.35|0.140
72370047|NCT02105961|144250543|SUPERIORITY||Rate ratio (Mepolizumab 100/Placebo)|0.59||||0.042|TWO_SIDED|95.0|0.35|0.98||Unadjusted p-value|Negative binomial model||Analysis using a negative binomial model with covariates of treatment, geographic region, no. of moderate/severe exacerbations in previous year, Baseline percent predicted FEV1, smoking status and offset of log (time in on- and off- treatment period)|||0.98|0.35|0.042
72370048|NCT02105961|144250543|SUPERIORITY||Rate ratio (Mepolizumab 300/Placebo)|0.83||||0.447|TWO_SIDED|95.0|0.51|1.34||Adjusted p-value; Family wise type I error controlled within each endpoint using a Hochberg testing procedure|Negative binomial model||Analysis using a negative binomial model with covariates of treatment, geographic region, no. of moderate/severe exacerbations in previous year, Baseline percent predicted FEV1, smoking status and offset of log (time in on- and off- treatment period)|||1.34|0.51|0.447
72370049|NCT02105961|144250543|SUPERIORITY||Rate ratio (Mepolizumab 300/Placebo)|0.83||||0.447|TWO_SIDED|95.0|0.51|1.34||Unadjusted p-value|Negative binomial model||Analysis using a negative binomial model with covariates of treatment, geographic region, no. of moderate/severe exacerbations in previous year, Baseline percent predicted FEV1, smoking status and offset of log (time in on- and off- treatment period)|||1.34|0.51|0.447
72370050|NCT02105961|144250544|SUPERIORITY||Mean difference(Mepolizumab 100-Placebo)|-1.8||||0.447|TWO_SIDED|95.0|-4.5|0.8||Adjusted p-value; Family wise type I error controlled within each endpoint using a Hochberg testing procedure|Mixed Model Repeated Measures Analysis||Analysis performed using mixed model repeated measures with covariates of Baseline SGRQ total score, geographic region, smoking status, treatment and visit, plus interaction terms for visit by Baseline and visit by treatment group.|||0.8|-4.5|0.447
72370051|NCT02105961|144250544|SUPERIORITY||Mean difference(Mepolizumab 100-Placebo)|-1.8||||0.18|TWO_SIDED|95.0|-4.5|0.8||Unadjusted p-value|Mixed Model Repeated Measures Analysis||Analysis performed using mixed model repeated measures with covariates of Baseline SGRQ total score, geographic region, smoking status, treatment and visit, plus interaction terms for visit by Baseline and visit by treatment group.|||0.8|-4.5|0.180
72370052|NCT02105961|144250544|SUPERIORITY||Mean difference(Mepolizumab 300-Placebo)|-0.1||||0.926|TWO_SIDED|95.0|-2.8|2.6||Adjusted p-value; Family wise type I error controlled within each endpoint using a Hochberg testing procedure|Mixed Model Repeated Measures Analysis||Analysis performed using mixed model repeated measures with covariates of Baseline SGRQ total score, geographic region, smoking status, treatment and visit, plus interaction terms for visit by Baseline and visit by treatment group.|||2.6|-2.8|0.926
72428479|NCT00600743|144367898|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|128.2|STANDARD_ERROR_OF_MEAN|41.4||0.007|TWO_SIDED|95.0||||t test following ANOVA for difference between drug and placebo - There were 3 doses, and the value reported is for the highest and only effective dose|t-test, 2 sided|The overall error term was used to compare differences between placebo and drug||Repeated measures ANOVA||||0.007
72428480|NCT00600743|144367899|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|49.4|STANDARD_ERROR_OF_MEAN|22.8||0.033|TWO_SIDED|95.0||||t-test after ANOVA with repeated measures on placebo minus drug (within groups) between binge and normal instructions (between groups)|t-test, 2 sided|This was part of an overall ANOVA (SAS proc mixed) with all four groups (3 doses eat normally. 4 ng dose, binge eat) and the error term had 76 df.||Each group was compared separately in an overall ANOVA with all dose groups included. The results are presented for the groups which received 4 mg dose and instructions to eat normally (normal group) or to binge eat (binge group). The test is the interaction between drug and group i.e. drug effect difference (placebo minus drug) in fullness between the group instructed to binge and the group instructed to eat normally.||||.033
72428481|NCT00600743|144367900|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|33.4286|STANDARD_ERROR_OF_MEAN|13.134|<|0.014|TWO_SIDED|||||p-value is based on ANOVA with all groups and conditions and is a planned comparison|ANOVA||df = 53. 26 Used proc GLMMIX in SAS 9.4.|Tests the difference between drug and placebo for group = binge instructions||||<.014
72428482|NCT01177813|144367901|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.74|STANDARD_ERROR_OF_MEAN|0.07|<|0.0001|TWO_SIDED|97.5|-0.9|-0.57||Difference calculated as empagliflozin 10mg minus placebo|ANCOVA|||Model was adjusted for treatment,geographical region, and renal function at baseline as fixed effects, and baseline HbA1c as linear covariate||-0.57|-0.90|<0.0001
72428483|NCT01177813|144367901|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.85|STANDARD_ERROR_OF_MEAN|0.07|<|0.0001|TWO_SIDED|97.5|-1.01|-0.69||Difference calculated as empagliflozin 25mg minus placebo|ANCOVA|||Model was adjusted for treatment,geographical region, and renal function at baseline as fixed effects, and baseline HbA1c as linear covariate||-0.69|-1.01|<0.0001
72428484|NCT01177813|144367902|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.93|STANDARD_ERROR_OF_MEAN|0.24|<|0.0001|TWO_SIDED|97.5|-2.48|-1.38||Difference calculated as empagliflozin 10mg minus placebo|ANCOVA|||Model was adjusted for treatment,geographical region,and renal function at baseline as fixed effects,baseline body weight and baseline HbA1c as linear covariate||-1.38|-2.48|<0.0001
72428485|NCT01177813|144367902|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.15|STANDARD_ERROR_OF_MEAN|0.24|<|0.0001|TWO_SIDED|95.0|-2.7|-1.6||Difference calculated as empagliflozin 25mg minus placebo|ANCOVA|||Model was adjusted for treatment,geographical region,and renal function at baseline as fixed effects,baseline body weight and baseline HbA1c as linear covariate||-1.60|-2.70|<0.0001
72428486|NCT01177813|144367903|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.6|STANDARD_ERROR_OF_MEAN|1.1||0.0231|TWO_SIDED|97.5|-5.2|0.0||Difference calculated as empagliflozin 10mg minus placebo|ANCOVA|||"Comparison for Systolic Blood Pressure~Model was adjusted for treatment,geographical region, and renal function at baseline as fixed effects, baseline SBP and baseline HbA1c as linear covariate"||0.0|-5.2|0.0231
72428487|NCT01177813|144367903|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.4|STANDARD_ERROR_OF_MEAN|1.1||0.0028|TWO_SIDED|97.5|-6.0|-0.9||Difference calculated as empagliflozin 25mg minus placebo|ANCOVA|||"Comparison for Systolic blood pressure~Model was adjusted for treatment,geographical region, and renal function at baseline as fixed effects, baseline SBP and baseline HbA1c as linear covariate"||-0.9|-6.0|0.0028
72428488|NCT01177813|144367903|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.7||0.3987|TWO_SIDED|97.5|-2.1|0.9||Difference calculated as empagliflozin 10mg minus placebo|ANCOVA|||"Comparison for diastolic blood pressure~Model was adjusted for treatment,geographical region, and renal function at baseline as fixed effects, baseline DBP and baseline HbA1c as linear covariate"||0.9|-2.1|0.3987
72341530|NCT01969721|144206936|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.039|STANDARD_ERROR_OF_MEAN|0.012||0.0007|TWO_SIDED|95.0|0.017|0.062||p-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is two-sided alpha=0.05.|Mixed Models Analysis|Compound symmetry covariance structure for within-patient variation and Kenward-Roger approximation of denominator degrees of freedom.|Difference calculated T+O 5/5 - F+S 250/50 adjusted mean FEV1 AUC 12-24h change from patient baseline (L)|Null hypothesis: Mean FEV1 AUC 12-24h change from patient baseline (Tiotropium + Olodaterol 5/5 μg) = Mean FEV1 AUC 12-24h change from patient baseline (Fluticasone propionate + Salmeterol 250/50 μg). Hypothesis was analysed using a restricted maximum likelihood-based mixed effect repeated measures model including fixed effects of treatment and period; period baseline and patient baseline as covariates; patient as a random effect.||0.062|0.017|0.0007
72428489|NCT01177813|144367903|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.5|STANDARD_ERROR_OF_MEAN|0.7||0.0296|TWO_SIDED|97.5|-3.0|0.0||Difference calculated as empagliflozin 25mg minus placebo|ANCOVA|||"Comparison for diastolic blood pressure~Model was adjusted for treatment,geographical region, and renal function at baseline as fixed effects, baseline DBP and baseline HbA1c as linear covariate"||0.0|-3.0|0.0296
72428490|NCT00581256|144367905|SUPERIORITY_OR_OTHER|||||||0.6|||||||Fisher Exact|||A Perfusion Defect (PD) increase of greater than 5% for a 2.5 SD threshold was considered significant.||||0.6
72428491|NCT00581256|144367905|SUPERIORITY_OR_OTHER|||||||0.46|||||||Fisher Exact|||A PD increase of greater than 10% for a 1.5 SD threshold was considered significant.||||0.46
72428492|NCT01196104|144367913|NON_INFERIORITY_OR_EQUIVALENCE|Study terminated early due to business reasons, results are not properly powered.|Mean Difference (Final Values)|-0.0473|STANDARD_ERROR_OF_MEAN|0.2158||0.8283|TWO_SIDED|95.0|-0.4901|0.3956|||ANCOVA|||ANCOVA model with terms of treatment as a fixed effect and baseline HbA1c as covariate||0.3956|-0.4901|0.8283
72428493|NCT00267111|144367947|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05||95.0||||Statistical analyses were performed using SPSS v12, USA). Pain scores were compared between groups by means of the Student t-test. A p-value of \< 0.05 was considered significant.|t-test, 2 sided|||We hypothesized that topical amethocaine gel 4% would reduce the pain from IM injection. The sample size was based on the pain scores obtained from a previous study that compared pain response during IM injection. To achieve a clinically significant reduction in pain scores by 20% between groups with 80% power and an alpha value of \< 0.05, we estimated sample size of 49 neonates in each group. A total of 110 neonates were enrolled to account for possible dropouts and missing data.||||< 0.05
72341531|NCT01969721|144206936|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.043|STANDARD_ERROR_OF_MEAN|0.011||0.0002|TWO_SIDED|95.0|0.021|0.065||p-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is two-sided alpha=0.05.|Mixed Models Analysis|Compound symmetry covariance structure for within-patient variation and Kenward-Roger approximation of denominator degrees of freedom.|Difference calculated as T+O 5/5 - F+S 500/50 adjusted mean FEV1 AUC 12-24h change from patient baseline (L)|Null hypothesis: Mean FEV1 AUC 12-24h change from patient baseline (Tiotropium + Olodaterol 5/5 μg) = Mean FEV1 AUC 12-24h change from patient baseline (Fluticasone propionate + Salmeterol 500/50 μg). Hypothesis was analysed using a restricted maximum likelihood-based mixed effect repeated measures model including fixed effects of treatment and period; period baseline and patient baseline as covariates; patient as a random effect.||0.065|0.021|0.0002
72428494|NCT00267111|144367948|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05||95.0||||Statistical analyses were performed using SPSS v12, USA). Pain scores were compared between groups by means of the Student t-test. A p-value of \< 0.05 was considered significant|t-test, 2 sided|||We hypothesized that parents and nurses will report lower pain scores as assessed by visual analogue scale in topical amethocaine gel 4% compared to placebo group. This was a secondary outcome and no power calculation was performed.||||<0.05
72428495|NCT02368002|144367955|SUPERIORITY|||||||0.25||||||2 df re-random\*time interaction tested if baseline to 6M or 18M PCM and ABT weight changes differed; primary hypothesis tests were 2 planned contrasts estimating baseline to 6M (H1a, expected neg) and 18M (H1b, expected pos) PCM vs. ABT weight change|Mixed Models Analysis|The mixed model included a random participant intercept. Fixed covariates were baseline weight, TRA timing, sex, weight loss rate.||H1 predicted that suboptimal responders re-randomized to PCM would lose more weight at 6m (H1a) while those re-randomized to ABT would lose more weight at 18m (H1b). A mixed linear model predicted weight change from fixed re-randomization, measurement time, the re-randomization by measurement time interaction and covariate parameters.|The primary hypothesis tests were two planned contrasts that estimated weight change from baseline to 6M and 18M relative to baseline in PCM relative to ABT. A mixed linear model predicted weight changes between baseline and post-baseline for suboptimal responders, and this model included two a priori simple effects tests resulting in two mean differences, confidence intervals, and p-values. H1a: -2.7 lbs; 95% CI: -5.8, 0.5; p=0.09. H1b: -1.0 lbs; 95% CI: -4.2, 2.2; p=0.53|||0.25
72428496|NCT02368002|144367956|SUPERIORITY||Mean Difference (Net)|-0.1||||0.96|TWO_SIDED|95.0|-2.4|2.3|||Mixed Models Analysis|The mixed model included a random participant intercept. Fixed covariates were baseline weight, sex, TRA result (PCM, ABT, responder, pre-TRA quit).||Hypothesis 2 predicted that among all participants, those randomized to Early TRA would lose more weight at 6 and 18 months than those randomized to Late TRA. A mixed linear model predicted weight change from fixed treatment response assessment timing and covariate parameters.||2.3|-2.4|0.96
72428497|NCT01183650|144367982|SUPERIORITY_OR_OTHER||Ratio of Geometric Least Squares Means|1.05|||||TWO_SIDED|90.0|0.84|1.32|||||Day 1 Tadalafil Ratio of Geometric Least Squares Means (Japanese/Caucasian)|||1.32|0.84|
72428498|NCT01183650|144367982|SUPERIORITY_OR_OTHER||Ratio of Geometric Least Squares Means|0.8|||||TWO_SIDED|90.0|0.64|1.0|||||Day 10 Tadalafil Ratio of Geometric Least Squares Means (Japanese/Caucasian)|||1.00|0.64|
72428499|NCT01183650|144367982|SUPERIORITY_OR_OTHER||Ratio of Geometric Least Squares Means|1.31|||||TWO_SIDED|90.0|1.05|1.64|||||Day 1 Metabolite IC710 Ratio of Geometric Least Squares Means (Japanese/Caucasian)|||1.64|1.05|
72428500|NCT01183650|144367982|SUPERIORITY_OR_OTHER||Ratio of Geometric Least Squares Means|0.99|||||TWO_SIDED|90.0|0.79|1.24|||||Day 10 Metabolite IC710 Ratio of Geometric Least Squares Means (Japanese/Caucasian)|||1.24|0.79|
72428501|NCT01183650|144367983|SUPERIORITY_OR_OTHER||Ratio of Geometric Least Squares Means|0.98|||||TWO_SIDED|90.0|0.81|1.18|||||Day 1 Tadalafil Ratio of Geometric Least Squares Means(Japanese/Caucasian)|||1.18|0.81|
72428502|NCT01183650|144367983|SUPERIORITY_OR_OTHER||Ratio of Geometric Least Squares Means|0.81|||||TWO_SIDED|90.0|0.67|0.97|||||Day 10 Tadalafil Ratio of Geometric Least Squares Means (Japanese/Caucasian)|||0.97|0.67|
72428503|NCT01183650|144367983|SUPERIORITY_OR_OTHER||Ratio of Geometric Least Squares Mean|1.33|||||TWO_SIDED|90.0|1.07|1.67|||||Day 1 Metabolite IC710 Ratio of Geometric Least Squares Means (Japanese/Caucasian)|||1.67|1.07|
72428504|NCT01183650|144367983|SUPERIORITY_OR_OTHER||Ratio of Geometric Least Squares Means|1.03|||||TWO_SIDED|90.0|0.83|1.29|||||Day 10 Metabolite IC710 Ratio of Geometric Least Squares Means (Japanese/Caucasian)|||1.29|0.83|
72428505|NCT01183650|144367984|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||||95.0|||||Wilcoxon (Mann-Whitney)|Tadalafil Median Difference (Day 1 - Day 10) in Japanese Participants||||||
72428506|NCT01183650|144367984|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||||95.0|||||Wilcoxon (Mann-Whitney)|Tadalafil Median Difference (Day 1 - Day 10) in Caucasian Participants||||||
72428507|NCT01183650|144367984|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|19.83||||||95.0|||||Wilcoxon (Mann-Whitney)|Metabolite IC710 Median Difference (Day 1 - Day 10) in Japanese participants||||||
72428508|NCT01183650|144367984|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.02||||||95.0|||||Wilcoxon (Mann-Whitney)|Metabolite IC710 Median Difference (Day 1 - Day 10) in Caucasian participants||||||
72428509|NCT01284140|144367985|OTHER|||||||0.37|||||||Extra sum-of-squares F test|The null hypothesis that model parameters of amplitude and phase were the same on Day 1 and Day 3 was not rejected for the Usual Care group.||Nonlinear regression using the least-squares approach was used to fit a single 24-hour cosine curve to all normalized data in each group on each day of 24-hour urine collection. Model parameters of acrophase and amplitude and their standard errors were derived from these curves. Using the extra sum-of-squares F test, the null hypothesis that model parameters of amplitude and phase were the same on Day 1 and Day 3 was tested for the Usual Care group.||||0.37
72428510|NCT01284140|144367985|OTHER|||||||0.0074|||||||Extra sum-of-squares F test|This result suggests that the best-fit values for amplitude and phase are different between Day 1 and Day 3 in the Sleep Promotion group.||Nonlinear regression using the least-squares approach was used to fit a single 24-hour cosine curve to all normalized data in each group on each day of 24-hour urine collection. Model parameters of acrophase and amplitude and their standard errors were derived from these curves. Using the extra sum-of-squares F test, the null hypothesis that model parameters of amplitude and phase were the same on Day 1 and Day 3 was tested for the Sleep promotion group.||||0.0074
72428511|NCT01284140|144367986|SUPERIORITY|||||||0.55|||||||Fisher Exact|||||||0.55
72341532|NCT01969721|144206936|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.028|STANDARD_ERROR_OF_MEAN|0.011||0.0146|TWO_SIDED|95.0|0.006|0.051||p-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is two-sided alpha=0.05.|Mixed Models Analysis|Compound symmetry covariance structure for within-patient variation and Kenward-Roger approximation of denominator degrees of freedom.|Difference calculated as T+O 2.5/5 - F+S 250/50 adjusted mean FEV1 AUC 12-24h change from patient baseline (L)|Null hypothesis: Mean FEV1 AUC 12-24h change from patient baseline (Tiotropium + Olodaterol 2.5/5 μg) = Mean FEV1 AUC 12-24h change from patient baseline (Fluticasone propionate + Salmeterol 250/50 μg). Hypothesis was analysed using a restricted maximum likelihood-based mixed effect repeated measures model including fixed effects of treatment and period; period baseline and patient baseline as covariates; patient as a random effect.||0.051|0.006|0.0146
72341533|NCT01969721|144206936|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.032|STANDARD_ERROR_OF_MEAN|0.011||0.0055|TWO_SIDED|95.0|0.009|0.054||p-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is two-sided alpha=0.05.|Mixed Models Analysis|Compound symmetry covariance structure for within-patient variation and Kenward-Roger approximation of denominator degrees of freedom.|Difference calculated as T+O 2.5/5 - F+S 500/50 adjusted mean FEV1 AUC 12-24h change from patient baseline (L)|Null hypothesis: Mean FEV1 AUC 12-24h change from patient baseline (Tiotropium + Olodaterol 2.5/5 μg) = Mean FEV1 AUC 12-24h change from patient baseline (Fluticasone propionate + Salmeterol 500/50 μg). Hypothesis was analysed using a restricted maximum likelihood-based mixed effect repeated measures model including fixed effects of treatment and period; period baseline and patient baseline as covariates; patient as a random effect.||0.054|0.009|0.0055
72341534|NCT01969721|144206937|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.142|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|0.118|0.166||p-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is two-sided alpha=0.05.|Mixed Models Analysis|Compound symmetry covariance structure for within-patient variation and Kenward-Roger approximation of denominator degrees of freedom.|Difference calculated as T+O 5/5 - F+S 250/50 adjusted mean FEV1 peak (0-3h) change from patient baseline (L)|Null hypothesis: Mean FEV1 peak (0-3h) change from patient baseline (Tiotropium + Olodaterol 5/5 μg) = Mean FEV1 peak (0-3h) change from patient baseline (Fluticasone propionate + Salmeterol 250/50 μg). Hypothesis was analysed using a restricted maximum likelihood-based mixed effect repeated measures model including fixed effects of treatment and period; period baseline and patient baseline as covariates; patient as a random effect.||0.166|0.118|<0.0001
72341535|NCT01969721|144206937|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.147|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|0.123|0.171||p-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is two-sided alpha=0.05.|Mixed Models Analysis|Compound symmetry covariance structure for within-patient variation and Kenward-Roger approximation of denominator degrees of freedom.|Difference calculated as T+O 5/5 - F+S 500/50 adjusted mean FEV1 peak (0-3h) change from patient baseline (L)|Null hypothesis: Mean FEV1 peak (0-3h) change from patient baseline (Tiotropium + Olodaterol 5/5 μg) = Mean FEV1 peak (0-3h) change from patient baseline (Fluticasone propionate + Salmeterol 500/50 μg). Hypothesis was analysed using a restricted maximum likelihood-based mixed effect repeated measures model including fixed effects of treatment and period; period baseline and patient baseline as covariates; patient as a random effect.||0.171|0.123|<0.0001
72341536|NCT01969721|144206937|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.111|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|0.087|0.135||p-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is two-sided alpha=0.05.|Mixed Models Analysis|Compound symmetry covariance structure for within-patient variation and Kenward-Roger approximation of denominator degrees of freedom.|Difference calculated as T+O 2.5/5 - F+S 250/50 adjusted mean FEV1 peak (0-3h) change from patient baseline (L)|Null hypothesis: Mean FEV1 peak (0-3h) change from patient baseline (Tiotropium + Olodaterol 2.5/5 μg) = Mean FEV1 peak (0-3h) change from patient baseline (Fluticasone propionate + Salmeterol 250/50 μg). Hypothesis was analysed using a restricted maximum likelihood-based mixed effect repeated measures model including fixed effects of treatment and period; period baseline and patient baseline as covariates; patient as a random effect.||0.135|0.087|<0.0001
72341537|NCT01969721|144206937|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.116|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|0.092|0.14||p-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is two-sided alpha=0.05.|Mixed Models Analysis|Compound symmetry covariance structure for within-patient variation and Kenward-Roger approximation of denominator degrees of freedom.|Difference calculated as T+O 2.5/5 - F+S 500/50 adjusted mean FEV1 peak (0-3h) change from patient baseline (L)|Null hypothesis: Mean FEV1 peak (0-3h) change from patient baseline (Tiotropium + Olodaterol 2.5/5 μg) = Mean FEV1 peak (0-3h) change from patient baseline (Fluticasone propionate + Salmeterol 500/50 μg). Hypothesis was analysed using a restricted maximum likelihood-based mixed effect repeated measures model including fixed effects of treatment and period; period baseline and patient baseline as covariates; patient as a random effect.||0.140|0.092|<0.0001
72341538|NCT02227394|144206980|OTHER|The difference between the predose and postdose values of test product and the reference product was compared after applying Benjamini-Hochberg correction (BH) to control the false discovery rate and after Holm-Bonferroni correction (Holm) to control the family-wise error rate.|Mean Difference (Net)|-0.187||||0.727|TWO_SIDED|90.0|-1.098|0.724|||t-test, 2 sided|||||0.724|-1.098|0.727
72341539|NCT02227394|144206981|OTHER|The difference between the predose and postdose values of test product and the reference product was compared after applying Benjamini-Hochberg correction (BH) to control the false discovery rate and after Holm-Bonferroni correction (Holm) to control the family-wise error rate.|Mean Difference (Net)|0.003||||0.366|TWO_SIDED|90.0|-0.002|0.007|||t-test, 2 sided|||||0.007|-0.002|0.366
72428512|NCT01284140|144367987|SUPERIORITY||Mean Difference (Final Values)|0.03||||0.03|TWO_SIDED||||||t-test, 2 sided|||Nonlinear regression using the least-squares approach was used to fit a single 24-hour cosine curve to all normalized data in each group on each day of 24-hour urine collection. This resulted in 4 separate best-fit curves. The model parameter of amplitude was derived from the best-fit curves.||||0.03
72428513|NCT03192215|144368002|SUPERIORITY||Hazard Ratio (HR)|1.0||||0.99|TWO_SIDED|95.0|0.64|1.55|||Log Rank|||||1.55|0.64|0.99
72428514|NCT03192215|144368003|SUPERIORITY||Hazard Ratio (HR)|0.92||||0.72|TWO_SIDED|95.0|0.59|1.44|||Log Rank|||||1.44|0.59|0.72
72428515|NCT03192215|144368004|SUPERIORITY||Hazard Ratio (HR)|1.08||||0.67|TWO_SIDED|95.0|0.76|1.52|||Log Rank|||||1.52|0.76|0.67
72341540|NCT02227394|144206983|OTHER|The difference between the predose and postdose values of test product and the reference product was compared after applying Benjamini-Hochberg correction (BH) to control the false discovery rate and after Holm-Bonferroni correction (Holm) to control the family-wise error rate.|Mean Difference (Net)|0.025||||0.486|TWO_SIDED|90.0|-0.035|0.084|||t-test, 2 sided|||||0.084|-0.035|0.486
72341541|NCT02227394|144206984|OTHER|The difference between the predose and postdose values of test product and the reference product was compared after applying Benjamini-Hochberg correction (BH) to control the false discovery rate and after Holm-Bonferroni correction (Holm) to control the family-wise error rate.|Mean Difference (Net)|0.049||||0.413|TWO_SIDED|90.0|-0.052|0.15|||t-test, 2 sided|||||0.150|-0.052|0.413
72341542|NCT02227394|144206985|OTHER|The difference between the predose and postdose values of test product and the reference product was compared after applying Benjamini-Hochberg correction (BH) to control the false discovery rate and after Holm-Bonferroni correction (Holm) to control the family-wise error rate.|Mean Difference (Net)|-0.1||||0.375|TWO_SIDED|90.0|-0.289|0.09|||t-test, 2 sided|||||0.090|-0.289|0.375
72341543|NCT02227394|144206986|OTHER|The difference between the predose and postdose values of test product and the reference product was compared after applying Benjamini-Hochberg correction (BH) to control the false discovery rate and after Holm-Bonferroni correction (Holm) to control the family-wise error rate.|Mean Difference (Net)|0.009||||0.879|TWO_SIDED|90.0|-0.092|0.11|||t-test, 2 sided|||||0.110|-0.092|0.879
72341544|NCT02227394|144206987|OTHER|The difference between the predose and postdose values of test product and the reference product was compared after applying Benjamini-Hochberg correction (BH) to control the false discovery rate and after Holm-Bonferroni correction (Holm) to control the family-wise error rate.|Mean Difference (Net)|0.023||||0.819|TWO_SIDED|90.0|-0.149|0.195|||t-test, 2 sided|||||0.195|-0.149|0.819
72341545|NCT02227394|144206988|OTHER|The difference between the predose and postdose values of test product and the reference product was compared after applying Benjamini-Hochberg correction (BH) to control the false discovery rate and after Holm-Bonferroni correction (Holm) to control the family-wise error rate.|Mean Difference (Net)|-0.4||||0.643|TWO_SIDED|90.0|-1.87|1.07|||t-test, 2 sided|||||1.070|-1.870|0.643
72341546|NCT02227394|144206989|OTHER|The difference between the predose and postdose values of test product and the reference product was compared after applying Benjamini-Hochberg correction (BH) to control the false discovery rate and after Holm-Bonferroni correction (Holm) to control the family-wise error rate.|Mean Difference (Net)|0.011||||0.866|TWO_SIDED|90.0|-0.1|0.122|||t-test, 2 sided|||||0.122|-0.100|0.866
72428516|NCT03192215|144368005|SUPERIORITY||Difference of annual rate.|-0.011||||0.02|TWO_SIDED|95.0|-0.018|-0.003|||Exact Binomial Test|||||-0.003|-0.018|.02
72428517|NCT03192215|144368006|SUPERIORITY||Hazard Ratio (HR)|1.02||||0.98|TWO_SIDED|95.0|0.29|3.52|||Log Rank|||||3.52|0.29|0.98
72428518|NCT03192215|144368007|SUPERIORITY||Hazard Ratio (HR)|1.53||||0.35|TWO_SIDED|95.0|0.63|3.75|||Log Rank|||||3.75|0.63|0.35
72428519|NCT02593032|144368008|SUPERIORITY||Mean Difference (Net)|12.0|||<|0.05|TWO_SIDED|||||This is the calculated p-value, not a threshold.|t-test, 2 sided|||||||<0.05
72428520|NCT05199233|144368009|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|The mean change from baseline was compared to zero using a one-sample t-test.||||||<0.001
72428521|NCT05199233|144368010|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|The mean change from baseline was compared to zero using a one-sample t-test.||||||<0.001
72428522|NCT02144519|144368056|SUPERIORITY||Odds Ratio (OR)|1.88||||0.008|TWO_SIDED|95.0|1.18|3.0|||Mixed Models Analysis|||||3.00|1.18|0.008
72428523|NCT02144519|144368057|SUPERIORITY||Odds Ratio (OR)|3.8||||0.003|TWO_SIDED|95.0|1.45|9.95|||Regression, Logistic|||||9.95|1.45|0.003
72428524|NCT00614198|144368058|SUPERIORITY_OR_OTHER||||||<|0.01||||||A priori p threshold set for stage 1 (baseline - 8m; p\<0.01) or (baseline - 12 months, p\<0.05) in order to progress to stage 2 (8 or 12 months - 20 or 24 months).|Mixed Models Analysis|||1st stage analysis (baseline-8m or 12m) used a repeated measures model for all assessment measures. Model included baseline, age, time and time\*treatment interaction. Results informed 2nd stage (8 or 12 months - 20 or 24 months). 2nd stage analysis based on various statistical scenarios (baseline vs 12 months on intervention, 12 months of no intervention vs 12 on intervention, baseline vs 24 months on intervention). No ADOS assessments were used at 12 months because of risk of practice effects.||||<0.01
72428525|NCT00065468|144368060|NON_INFERIORITY_OR_EQUIVALENCE|2 null hypotheses (Ho) were tested: 1) Survival distributions for temsirolimus alone and Interferon Alfa (IFN)-alone treatment groups were identical. 2) Survival distributions for temsirolimus in combination with IFN and IFN-alone treatment groups were identical. The alternative hypothesis (Ha) for each test was that the survival distributions differed.|Cox Proportional Hazard|0.78||||0.0252|TWO_SIDED|95.0|0.63|0.97|||Log Rank|Stratified by prior nephrectomy and region||||0.97|0.63|0.0252
72428526|NCT00065468|144368060|NON_INFERIORITY_OR_EQUIVALENCE|2 null hypotheses (Ho) were tested: 1) Survival distributions for temsirolimus alone and IFN-alone treatment groups were identical. 2) Survival distributions for temsirolimus in combination with IFN and IFN-alone treatment groups were identical. The alternative hypothesis (Ha) for each test was that the survival distributions differed.|Cox Proportional Hazard|0.93||||0.4902|TWO_SIDED|95.0|0.75|1.15|||Log Rank|Stratified by prior nephrectomy and region||||1.15|0.75|0.4902
72341547|NCT02227394|144206990|OTHER|The difference between the predose and postdose values of test product and the reference product was compared after applying Benjamini-Hochberg correction (BH) to control the false discovery rate and after Holm-Bonferroni correction (Holm) to control the family-wise error rate.|Mean Difference (Net)|0.054||||0.346|TWO_SIDED|90.0|-0.043|0.152|||t-test, 2 sided|||||0.152|-0.043|0.346
72341548|NCT02227394|144206991|OTHER|The difference between the predose and postdose values of test product and the reference product was compared after applying Benjamini-Hochberg correction (BH) to control the false discovery rate and after Holm-Bonferroni correction (Holm) to control the family-wise error rate.|Mean Difference (Net)|0.029||||0.093|TWO_SIDED|90.0|0.001|0.058|||t-test, 2 sided|||||0.058|0.001|0.093
72428527|NCT00065468|144368061|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.74||||0.0042|TWO_SIDED|95.0|0.6|0.91|||Log Rank|Stratified by prior nephrectomy and region||||0.91|0.60|0.0042
72428528|NCT00065468|144368061|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.76||||0.0107|TWO_SIDED|95.0|0.62|0.94|||Log Rank|Stratified by prior nephrectomy and region||||0.94|0.62|0.0107
72428529|NCT00065468|144368062|SUPERIORITY_OR_OTHER|||||||0.1361|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by prior nephrectomy and region||||||0.1361
72341549|NCT02227394|144206992|OTHER|The difference between the predose and postdose values of test product and the reference product was compared after applying Benjamini-Hochberg correction (BH) to control the false discovery rate and after Holm-Bonferroni correction (Holm) to control the family-wise error rate.|Mean Difference (Net)|-0.074||||0.686|TWO_SIDED|90.0|-0.386|0.238|||t-test, 2 sided|||||0.238|-0.386|0.686
72341550|NCT02227394|144206994|OTHER|The difference between the predose and postdose values of test product and the reference product was compared after applying Benjamini-Hochberg correction (BH) to control the false discovery rate and after Holm-Bonferroni correction (Holm) to control the family-wise error rate.|Mean Difference (Net)|-10.368||||0.312|TWO_SIDED|90.0|-27.659|6.922|||t-test, 2 sided|||||6.922|-27.659|0.312
72341551|NCT02227394|144206995|OTHER|The difference between the predose and postdose values of test product and the reference product was compared after applying Benjamini-Hochberg correction (BH) to control the false discovery rate and after Holm-Bonferroni correction (Holm) to control the family-wise error rate.|Mean Difference (Net)|-0.02||||0.92|TWO_SIDED|90.0|-0.361|0.321|||t-test, 2 sided|||||0.321|-0.361|0.920
72341552|NCT02227394|144206996|OTHER|The difference between the predose and postdose values of test product and the reference product was compared after applying Benjamini-Hochberg correction (BH) to control the false discovery rate and after Holm-Bonferroni correction (Holm) to control the family-wise error rate.|Mean Difference (Net)|0.08||||0.818|TWO_SIDED|90.0|-0.513|0.673|||t-test, 2 sided|||||0.673|-0.513|0.818
72341553|NCT02227394|144206997|OTHER|The difference between the predose and postdose values of test product and the reference product was compared after applying Benjamini-Hochberg correction (BH) to control the false discovery rate and after Holm-Bonferroni correction (Holm) to control the family-wise error rate.|Mean Difference (Net)|11.4||||0.034|TWO_SIDED|90.0|2.789|20.011|||t-test, 2 sided|||||20.011|2.789|0.034
72341554|NCT02227394|144206998|OTHER|The difference between the predose and postdose values of test product and the reference product was compared after applying Benjamini-Hochberg correction (BH) to control the false discovery rate and after Holm-Bonferroni correction (Holm) to control the family-wise error rate.|Mean Difference (Net)|5.6||||0.427|TWO_SIDED|90.0|-6.323|17.523|||t-test, 2 sided|||||17.523|-6.323|0.427
72341555|NCT04051827|144206999|OTHER|Geometric Mean Ratio|Geometric Mean Ratio (GMR)|1.03|||||TWO_SIDED|90.0|0.739|1.42|||||The geometric mean ratio (GMR) of midazolam Cmax on Day 24 (with mobocertinib) versus on Day 1 (without mobocertinib) were calculated.|The ratios of geometric mean midazolam Cmax (in the presence vs absence of mobocertinib) and the associated 2-sided 90 percent (%) confidence intervals (CIs) were calculated on the basis of the within-patient variance using a mixed-effects analysis of variance (ANOVA) model fitting terms for treatment (midazolam in the absence and presence of mobocertinib).||1.42|0.739|
72341556|NCT04051827|144207000|OTHER|Geometric Mean Ratio|Geometric Mean Ratio (GMR)|0.676|||||TWO_SIDED|90.0|0.532|0.859|||||The GMR of midazolam AUC∞ on Day 24 (with mobocertinib) versus on Day 1 (without mobocertinib) were calculated.|The ratios of geometric mean midazolam AUC∞ (in the presence vs absence of mobocertinib) and the associated 2-sided 90% CIs were calculated on the basis of the within-patient variance using a mixed-effects ANOVA model fitting terms for treatment (midazolam in the absence and presence of mobocertinib).||0.859|0.532|
72341557|NCT04051827|144207001|OTHER|Geometric Mean Ratio|Geometric Mean Ratio (GMR)|1.3|||||TWO_SIDED|90.0|0.886|1.92|||||The GMR of midazolam Cmax on Day 25 (with mobocertinib) versus on Day 2 (without mobocertinib) were calculated.|The ratios of geometric mean midazolam Cmax (in the presence vs absence of mobocertinib) and the associated 2-sided 90% CIs were calculated on the basis of the within-patient variance using a mixed-effects ANOVA model fitting terms for treatment (midazolam in the absence and presence of mobocertinib).||1.92|0.886|
72341558|NCT04051827|144207002|OTHER|Geometric Mean Ratio|Geometric Mean Ratio (GMR)|0.837|||||TWO_SIDED|90.0|0.673|1.04|||||The GMR of midazolam AUC∞ on Day 25 (with mobocertinib) versus on Day 2 (without mobocertinib) were calculated.|The ratios of geometric mean midazolam AUC∞ (in the presence vs absence of mobocertinib) and the associated 2-sided 90% CIs were calculated on the basis of the within-patient variance using a mixed-effects ANOVA model fitting terms for treatment (midazolam in the absence and presence of mobocertinib).||1.04|0.673|
72341559|NCT03743064|144207027|SUPERIORITY|The Multiple Imputation process (N=100) was performed leading to least squares mean (LSM) and standard error (SE) estimates using the ANOVA model (including treatment group and the 3 stratification factors at randomization as categorical covariates). The estimates were pooled using Rubin rule, with corresponding p-value for difference between treatment groups. The 95% confidence interval (CI) was calculated for each treatment group and for the pooled difference between the groups.|Mean Difference (Final Values)|1.284|STANDARD_ERROR_OF_MEAN|0.289|<|0.0001|TWO_SIDED|95.0|0.718|1.851|||ANOVA|||"To declare anamorelin superior to placebo, both co-primary endpoints had to be significant.~The null hypothesis for mean change in body weight from baseline over 12 weeks (H0w) and the corresponding alternative hypothesis (H1w) were:~H0w: MWa = MWp H1w: MWa ≠ MWp~Where MWa is the mean change in body weight from baseline over 12 weeks for the anamorelin arm and MWp is the mean change in body weight from baseline over 12 weeks for the placebo arm."||1.851|0.718|<0.0001
72368380|NCT00298558|144246919|SUPERIORITY_OR_OTHER||Effect Size|0.23|||<|0.01|TWO_SIDED|99.0|0.09|0.38|||Mixed Models Analysis|The blom transformation was used to reduce skewness in the measures. The design factors and baseline covariates were controlled in the model.|Blom transformed outcome was used and the design factors and baseline covariates were controlled in the model to get the adjusted means. After that, the effect size (defined in the Additional details) was calculated using the adjusted means and SD.|Effect size was defined as training improvement from baseline to year 10 minus control improvement from baseline to year 10 divided by the intrasubject standard deviation (SD) of the composite score. Positive effect sizes indicate improvement.||0.38|0.09|<0.01
72428530|NCT00065468|144368062|SUPERIORITY_OR_OTHER|||||||0.1062|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by prior nephrectomy and region||||||0.1062
72428531|NCT00065468|144368063|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by prior nephrectomy and region||||||<0.0001
72428532|NCT00065468|144368063|SUPERIORITY_OR_OTHER|||||||0.0011|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by prior nephrectomy and region||||||0.0011
72428533|NCT00065468|144368065|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.62|||<|0.0001|TWO_SIDED|95.0|0.51|0.76|||Log Rank|Stratified by prior nephrectomy and region||||0.76|0.51|<0.0001
72428534|NCT00065468|144368065|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.73||||0.002|TWO_SIDED|95.0|0.6|0.89|||Log Rank|Stratified by prior nephrectomy and region||||0.89|0.60|0.0020
72428535|NCT01225835|144368068|SUPERIORITY_OR_OTHER|||||||0.003||95.0||||The significance level is 0.05.|t-test, 2 sided|||||||0.003
72428536|NCT01225835|144368068|SUPERIORITY_OR_OTHER|||||||0.015||95.0||||The significance level is 0.05.|t-test, 2 sided|||Age \< 39 years||||0.015
72428537|NCT01225835|144368068|SUPERIORITY_OR_OTHER|||||||0.027||95.0||||The significance level is 0.05.|t-test, 2 sided|||Age \>= 39 years||||0.027
72428538|NCT01225835|144368070|SUPERIORITY_OR_OTHER|||||||1||95.0||||The significance level is 0.05.|Fisher Exact|||||||1.00
72428539|NCT01225835|144368071|SUPERIORITY_OR_OTHER|||||||0.004||95.0||||The significance level is 0.05. P-values are not adjusted for multiple tests and have to be interpreted exploratively.|Wilcoxon (Mann-Whitney)|||||||0.004
72428540|NCT01225835|144368072|SUPERIORITY_OR_OTHER|||||||0.121||95.0||||The significance level is 0.05.|t-test, 2 sided|||||||0.121
72428541|NCT01225835|144368073|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Level of significance is 0.05.|Wilcoxon (Mann-Whitney)|||||||<0.001
72428542|NCT01225835|144368074|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The significance level is 0.05. P-values are not adjusted for multiple tests and have to be interpreted exploratively.|Wilcoxon (Mann-Whitney)|||||||<0.001
72368381|NCT00298558|144246919|SUPERIORITY_OR_OTHER||Effect Size|-0.06||||0.27|TWO_SIDED|99.0|-0.2|0.08|||Mixed Models Analysis|The blom transformation was used to reduce skewness in the measures. The design factors and baseline covariates were controlled in the model.|Blom transformed outcome was used and the design factors and baseline covariates were controlled in the model to get the adjusted means. After that, the effect size (defined in the Additional details) was calculated using the adjusted means and SD.|Effect size was defined as training improvement from baseline to year 10 minus control improvement from baseline to year 10 divided by the intrasubject standard deviation (SD) of the composite score. Positive effect sizes indicate improvement.||0.08|-0.20|0.27
72428543|NCT01225835|144368076|SUPERIORITY_OR_OTHER|||||||0.482||95.0||||The significance level is 0.05. P-values are not adjusted for multiple tests and have to be interpreted exploratively.|Wilcoxon (Mann-Whitney)|||||||0.482
72428544|NCT01225835|144368077|SUPERIORITY_OR_OTHER|||||||0.871||||||The significance level is 0.05. P-values are not adjusted for multiple tests and have to be interpreted exploratively.|Chi-squared|||||||0.871
72428545|NCT01225835|144368078|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The significance level is 0.05. P-values are not adjusted for multiple tests and have to be interpreted exploratively.|Wilcoxon (Mann-Whitney)|||||||<0.001
72428546|NCT01225835|144368079|SUPERIORITY_OR_OTHER|||||||0.62||95.0||||The significance level is 0.05. P-values are not adjusted for multiple tests and have to be interpreted exploratively.|t-test, 2 sided|||||||0.620
72428547|NCT01225835|144368080|SUPERIORITY_OR_OTHER|||||||0.478||95.0||||The significance level is 0.05. P-values are not adjusted for multiple tests and have to be interpreted exploratively.|t-test, 2 sided|||||||0.478
72428548|NCT01225835|144368081|SUPERIORITY_OR_OTHER|||||||0.69||95.0||||The significance level is 0.05. P-values are not adjusted for multiple tests and have to be interpreted exploratively.|Fisher Exact|||||||0.69
72428549|NCT01225835|144368082|SUPERIORITY_OR_OTHER|||||||0.295||95.0||||The significance level is 0.05. P-values are not adjusted for multiple tests and have to be interpreted exploratively.|Wilcoxon (Mann-Whitney)|||||||0.295
72428550|NCT01225835|144368083|SUPERIORITY_OR_OTHER|||||||0.405||95.0||||The significance level is 0.05. P-values are not adjusted for multiple tests and have to be interpreted exploratively.|Wilcoxon (Mann-Whitney)|||||||0.405
72428551|NCT01225835|144368084|SUPERIORITY_OR_OTHER|||||||1||95.0||||The significance level is 0.05. P-values are not adjusted for multiple tests and have to be interpreted exploratively.|Fisher Exact|||||||1.000
72428552|NCT05515679|144368092|SUPERIORITY||Median Difference (Final Values)|0.72|STANDARD_DEVIATION|0.48|<|0.01|TWO_SIDED|95.0|0.51|0.94|||t-test, 2 sided|||Using a paired sample t-test (two tailed), we wished to examine whether there was an increase in Constructive Engagement and Pleasure and a reduction in Passive Engagement, Distracted Engagement, and Non-Engagement, from baseline to treatment. With an anticipated PWD sample of 24, and using means and standard deviations from the PI's previous studies, we calculated a power of 90% to detect effects (alpha = .05; one-tailed test). (3) PWD and staff report high satisfaction wi||.94|.51|<0.01
72428553|NCT05515679|144368093|SUPERIORITY||Mean Difference (Final Values)|-0.33|STANDARD_DEVIATION|0.6||0.017|TWO_SIDED|95.0|-0.59|-0.07|||t-test, 2 sided|||||-0.07|-0.59|.017
72428554|NCT05515679|144368094|SUPERIORITY||Mean Difference (Final Values)|-0.25|STANDARD_DEVIATION|0.41||0.008|TWO_SIDED|95.0|-0.43|-0.07|||t-test, 2 sided|||||-0.07|-0.43|.008
72428555|NCT05515679|144368095|SUPERIORITY||Median Difference (Final Values)|-0.15|STANDARD_DEVIATION|0.34||0.053|TWO_SIDED|95.0|-0.3|0.0|||t-test, 2 sided|||||-.00|-.30|0.053
72428556|NCT05515679|144368096|SUPERIORITY||Mean Difference (Final Values)|0.66|STANDARD_DEVIATION|0.28|<|0.01|TWO_SIDED|95.0|0.54|0.79|||t-test, 2 sided|||||.79|.54|<.01
72428557|NCT05515679|144368097|SUPERIORITY||Mean Difference (Final Values)|4.11|STANDARD_DEVIATION|3.35|<|0.001|TWO_SIDED|95.0|2.62|5.6|||t-test, 2 sided|||||5.60|2.62|<.001
72428558|NCT05515679|144368098|SUPERIORITY||Mean Difference (Final Values)|-1.07|STANDARD_DEVIATION|1.1|<|0.001|TWO_SIDED|95.0|-1.55|-0.58|||t-test, 2 sided|||||-0.58|-1.55|<.001
72428559|NCT05515679|144368099|SUPERIORITY||Median Difference (Final Values)|6.02|STANDARD_DEVIATION|11.4||0.022|TWO_SIDED|95.0|0.97|11.1|||t-test, 2 sided|||||11.1|0.97|.022
72428560|NCT05515679|144368100|SUPERIORITY||Mean Difference (Final Values)|1.23|STANDARD_DEVIATION|9.5||0.551|TWO_SIDED|95.0|-2.9|5.44|||t-test, 2 sided|||||5.44|-2.90|.551
72428561|NCT05515679|144368101|SUPERIORITY||Mean Difference (Final Values)|27.43|STANDARD_DEVIATION|0.11|<|0.001|TWO_SIDED|95.0|17.7|37.2|||t-test, 2 sided|||||37.2|17.7|<.001
72428562|NCT01952301|144368120|NON_INFERIORITY_OR_EQUIVALENCE|The primary hypothesis of the study evaluated whether CM was not inferior to Control in the generation of KT width from baseline to 6 months. A paired t-test was used to test for non-inferiority, using a one-sided significance level of 0.05 and a non-inferiority margin of 1.0 mm.|||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
72428563|NCT03844321|144368159|SUPERIORITY||Difference in Slopes|-0.02||||0.82|TWO_SIDED|95.0|-0.24|0.19||A two-sided significance level of 0.05 was used for all analyses.|Mixed Models Analysis|df = 1607|Slope estimate = difference in slopes between conditions (Mindfulness Light vs. Mindfulness-Based Cognitive Therapy) during time frame.|We used a linear mixed effects model to examine the difference in effect of time on weekly WHO-5 scores in Mindfulness Light vs. Mindfulness-Based Cognitive Therapy conditions from baseline to 8 weeks. This model accounts for the covariance of repeated measurements within subjects, and we used maximum likelihood estimation to adjust for missing assessment scores. The model includes a random slope and intercept, and fixed effects for intervention, time, and an intervention by time interaction.||0.19|-0.24|.820
72428564|NCT03844321|144368159|SUPERIORITY||Difference in Slopes|-0.08||||0.11|TWO_SIDED|95.0|-0.18|0.02||A two-sided significance level of .05 was used.|Mixed Models Analysis|df = 1147|Slope estimate = difference in slopes between conditions (Mindfulness Light vs. Mindfulness-Based Cognitive Therapy) during time frame.|We used a linear mixed effects model to examine the difference in effect of time on weekly WHO-5 scores in Mindfulness Light vs. Mindfulness-Based Cognitive Therapy conditions from baseline to 20 weeks. This model accounts for the covariance of repeated measurements within subjects, and we used maximum likelihood estimation to adjust for missing assessment scores. The model includes a random slope and intercept, and fixed effects for intervention, time, and an intervention by time interaction.||0.02|-0.18|.110
72428565|NCT03844321|144368160|SUPERIORITY||Difference in Slopes|-0.03||||0.284|TWO_SIDED|95.0|-0.07|0.02||A two-sided significance level of .05 was used.|Mixed Models Analysis|df= 1726|Slope estimate = difference in slopes between conditions (Mindfulness Light vs. Mindfulness-Based Cognitive Therapy) during time frame.|As with the primary outcome, we used a linear mixed effects model to examine the difference in effect of time on weekly PSS scores in Mindfulness Light vs. Mindfulness-Based Cognitive Therapy conditions from baseline to 8 weeks.||0.02|-0.07|.284
72428566|NCT03844321|144368160|SUPERIORITY||Difference in Slopes|0.01||||0.394|TWO_SIDED|95.0|-0.01|0.03||A two-sided significance level of .05 was used.|Mixed Models Analysis|df = 1018|Slope estimate = difference in slopes between conditions (Mindfulness Light vs. Mindfulness-Based Cognitive Therapy) during time frame.|As with the primary outcome, we used a linear mixed effects model to examine the difference in effect of time on weekly PSS scores in Mindfulness Light vs. Mindfulness-Based Cognitive Therapy conditions from baseline to 20 weeks.||0.03|-0.01|.394
72428567|NCT03844321|144368161|SUPERIORITY||Difference in Slopes|0.03||||0.431|TWO_SIDED|95.0|-0.04|0.09||A two-sided significance level of .05 was used.|Mixed Models Analysis|df = 1591|Slope estimate = difference in slopes between conditions (Mindfulness Light vs. Mindfulness-Based Cognitive Therapy) during time frame.|As with the primary outcome, we used a linear mixed effects model to examine the difference in effect of time on weekly PROMIS: Emotional Distress-Depression Short Form scores in Mindfulness Light vs. Mindfulness-Based Cognitive Therapy conditions from baseline to 8 weeks.||0.09|-0.04|.431
72428568|NCT03844321|144368161|SUPERIORITY||Difference in Slopes|0.05|||<|0.001|TWO_SIDED|95.0|0.02|0.08||A two-sided significance level of .05 was used.|Mixed Models Analysis|df = 1159|Slope estimate = difference in slopes between conditions (Mindfulness Light vs. Mindfulness-Based Cognitive Therapy) during time frame.|As with the primary outcome, we used a linear mixed effects model to examine the difference in effect of time on weekly PROMIS: Emotional Distress-Depression Short Form scores in Mindfulness Light vs. Mindfulness-Based Cognitive Therapy conditions from baseline to 20 weeks.||0.08|0.02|<.001
72428569|NCT03844321|144368162|SUPERIORITY||Difference in Slopes|-0.01||||0.399|TWO_SIDED|95.0|-0.05|0.02||A two-sided significance level of .05 was used.|Mixed Models Analysis|df = 1601|Slope estimate = difference in slopes between conditions (Mindfulness Light vs. Mindfulness-Based Cognitive Therapy) during time frame.|As with the primary outcome, we used a linear mixed effects model to examine the difference in effect of time on weekly PROMIS: Emotional Distress-Anxiety Short Form scores in Mindfulness Light vs. Mindfulness-Based Cognitive Therapy conditions from baseline to 8 weeks.||0.02|-0.05|.399
72341560|NCT03743064|144207028|SUPERIORITY|The Multiple Imputation process (N=100) was performed leading to least squares mean (LSM) and standard error (SE) estimates using the ANOVA model (including treatment group and the 3 stratification factors at randomization as categorical covariates). The estimates were pooled using Rubin rule, with corresponding p-value for difference between treatment groups. The 95% confidence interval (CI) was calculated for each treatment group and for the pooled difference between the groups.|Mean Difference (Final Values)|0.141|STANDARD_ERROR_OF_MEAN|0.399||0.7241|TWO_SIDED|95.0|-0.641|0.923|||ANOVA|||"To declare anamorelin superior to the placebo, both co-primary endpoints had to be significant. The null hypothesis for mean change from baseline over 12 weeks in patient 5-IASS (H0A) and the corresponding alternative (H1A) were:~H0A: MAa = MAp; H1A: MAa ≠ MAp~Where MAa is the mean change from baseline over 12 weeks in 5-IASS for the anamorelin arm and MAp is the mean change from baseline over 12 weeks in 5-IASS for the placebo arm."||0.923|-0.641|0.7241
72341561|NCT03743064|144207029|SUPERIORITY|All secondary endpoints were analyzed using the same statistical model and multiple imputation approach as for the co-primary efficacy endpoints.|Mean Difference (Final Values)|2.081|STANDARD_ERROR_OF_MEAN|0.579||0.0003|TWO_SIDED|95.0|0.946|3.216|||ANOVA|||||3.216|0.946|0.0003
72428570|NCT03844321|144368162|SUPERIORITY||Difference in Slopes|0.02||||0.048|TWO_SIDED|95.0|0.0|0.03||A two-sided significance level of .05 was used.|Mixed Models Analysis|df = 1171|Slope estimate = difference in slopes between conditions (Mindfulness Light vs. Mindfulness-Based Cognitive Therapy) during time frame.|As with the primary outcome, we used a linear mixed effects model to examine the difference in effect of time on weekly PROMIS: Emotional Distress-Anxiety Short Form scores in Mindfulness Light vs. Mindfulness-Based Cognitive Therapy conditions from baseline to 20 weeks.||0.03|0.00|.048
72341562|NCT03743064|144207030|SUPERIORITY|All secondary endpoints were analyzed using the same statistical model and multiple imputation approach as for the co-primary efficacy endpoints.|Mean Difference (Final Values)|2.404|STANDARD_ERROR_OF_MEAN|0.476|<|0.0001|TWO_SIDED|95.0|1.471|3.337|||ANOVA|||||3.337|1.471|<0.0001
72341563|NCT03743064|144207031|SUPERIORITY|All secondary endpoints were analyzed using the same statistical model and multiple imputation approach as for the co-primary efficacy endpoints.|Mean Difference (Final Values)|0.629|STANDARD_ERROR_OF_MEAN|0.431||0.1443|TWO_SIDED|95.0|-0.215|1.472|||ANOVA|||||1.472|-0.215|0.1443
72341564|NCT03743064|144207032|SUPERIORITY|All secondary endpoints were analyzed using the same statistical model and multiple imputation approach as for the co-primary efficacy endpoints.|Mean Difference (Final Values)|0.151|STANDARD_ERROR_OF_MEAN|0.452||0.7376|TWO_SIDED|95.0|-0.734|1.036|||ANOVA|||||1.036|-0.734|0.7376
72341565|NCT01302054|144207048|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-2.37|STANDARD_ERROR_OF_MEAN|0.17|<|0.0001|TWO_SIDED|95.0|-2.63|-2.02||Statistical testing: one-sided, at alpha = 0.025.|t-test, 1 sided|||||-2.02|-2.63|<0.0001
72341566|NCT01302054|144207049|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.19||0.0079|TWO_SIDED|95.0|-0.87|-0.13||Change at Week 12: ANCOVA model with terms for treatment and country with centered baseline value as a covariate was used. Statistical testing: one-sided, at alpha = 0.025.|ANCOVA|||Multiple hypothesis testing was carried out in a hierarchical sequentially rejective manner. Statistical testing between fesoterodine and placebo (Analysis of covariance \[ANCOVA\]) was carried out only if the change from baseline at Week 12 in UUI episodes for fesoterodine group was found statistically significant (paired t-test).||-0.13|-0.87|0.0079
72341567|NCT01302054|144207050|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.24||0.0931|TWO_SIDED|95.0|-0.86|0.07||Statistical testing: one-sided, at alpha = 0.025.|ANCOVA|||Change at Week 12: ANCOVA model with terms for treatment and country with centered baseline value as a covariate was used.||0.07|-0.86|0.0931
72341568|NCT01302054|144207051|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.34||0.0438|TWO_SIDED|95.0|-1.37|-0.02||Statistical testing: one-sided, at alpha = 0.025.|ANCOVA|||Change at Week 12: ANCOVA model with terms for treatment and country with centered baseline value as a covariate was used.||-0.02|-1.37|0.0438
72341569|NCT01302054|144207052|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Change at Week 12: the p-value was obtained from a Cochran-Mantel-Haenszel (CMH) test with modified ridit scoring controlling for country.|Cochran-Mantel-Haenszel|||||||<0.0001
72341570|NCT01302054|144207053|SUPERIORITY_OR_OTHER|||||||0.0095|TWO_SIDED|||||Change at Week 12: the p-value was obtained from a Cochran-Mantel-Haenszel (CMH) test with modified ridit scoring controlling for country.|Cochran-Mantel-Haenszel|||||||0.0095
72341571|NCT01302054|144207054|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-7.34|STANDARD_ERROR_OF_MEAN|1.91||0.0001|TWO_SIDED|95.0|-11.1|-3.58||Statistical testing: one-sided, at alpha = 0.025.|ANCOVA|||Change at Week 12: ANCOVA model with terms for treatment and country with centered baseline value as a covariate was used.||-3.58|-11.10|0.0001
72341572|NCT01302054|144207055|SUPERIORITY_OR_OTHER||Least Squares (LS) Mean Difference|9.01|STANDARD_ERROR_OF_MEAN|1.98|<|0.0001|TWO_SIDED|95.0|5.12|12.91||Statistical testing: one-sided, at alpha = 0.025.|ANCOVA|||Concern Subscale - Change at Week 12: ANCOVA model with terms for treatment and country with centered baseline value as a covariate was used.||12.91|5.12|<0.0001
72341573|NCT01302054|144207055|SUPERIORITY_OR_OTHER||LS Mean Difference|7.75|STANDARD_ERROR_OF_MEAN|1.97|<|0.0001|TWO_SIDED|95.0|3.87|11.62||Statistical testing: one-sided, at alpha = 0.025.|ANCOVA|||Coping Subscale - Change at Week 12: ANCOVA model with terms for treatment and country with centered baseline value as a covariate was used.||11.62|3.87|<0.0001
72341574|NCT01302054|144207055|SUPERIORITY_OR_OTHER||LS Mean Difference|6.52|STANDARD_ERROR_OF_MEAN|2.0||0.0012|TWO_SIDED|95.0|2.6|10.45||Statistical testing: one-sided, at alpha = 0.025.|ANCOVA|||Sleep Subscale - Change at Week 12: ANCOVA model with terms for treatment and country with centered baseline value as a covariate was used.||10.45|2.60|0.0012
72341575|NCT01302054|144207055|SUPERIORITY_OR_OTHER||LS Mean Difference|4.13|STANDARD_ERROR_OF_MEAN|1.64||0.0123|TWO_SIDED|95.0|0.9|7.36||Statistical testing: one-sided, at alpha = 0.025.|ANCOVA|||Social Interaction Subscale - Change at Week 12: ANCOVA model with terms for treatment and country with centered baseline value as a covariate was used.||7.36|0.90|0.0123
72341576|NCT01302054|144207055|SUPERIORITY_OR_OTHER||LS Mean Difference|7.1|STANDARD_ERROR_OF_MEAN|1.77|<|0.0001|TWO_SIDED|95.0|3.63|10.57||Statistical testing: one-sided, at alpha = 0.025.|ANCOVA|||Total HRQL - Change at Week 12: ANCOVA model with terms for treatment and country with centered baseline value as a covariate was used.||10.57|3.63|<0.0001
72341577|NCT01302054|144207056|SUPERIORITY_OR_OTHER|||||||0.0023|TWO_SIDED|||||The p-value was obtained from a Cochran-Mantel-Haenszel (CMH) general association test and stratified by country.|Cochran-Mantel-Haenszel|||||||0.0023
72341578|NCT01302054|144207057|SUPERIORITY_OR_OTHER|||||||0.0027|TWO_SIDED|||||The p-value was obtained from a Cochran-Mantel-Haenszel (CMH) general association test and stratified by country.|Cochran-Mantel-Haenszel|||||||0.0027
72341579|NCT01302054|144207058|SUPERIORITY_OR_OTHER|||||||0.0427|TWO_SIDED|||||Treatment difference at Week 4: p-value was obtained from a Cochran-Mantel-Haenszel (CMH) general association test and stratified by country.|Cochran-Mantel-Haenszel|||||||0.0427
72341580|NCT01302054|144207058|SUPERIORITY_OR_OTHER|||||||0.1461|TWO_SIDED|||||Treatment difference at Week 12: p-value was obtained from a Cochran-Mantel-Haenszel (CMH) general association test and stratified by country.|Cochran-Mantel-Haenszel|||||||0.1461
72341581|NCT02809053|144207059|OTHER|The 95%CI (confidence interval) for the difference in the overall response rate (ORR) was calculated using the Newcombe-Wilson method based on CMH (Cochran-Mantel-Haenszel) weight with stratification factor FLIPI-2 (low, intermediate and high risk).|Adjusted Difference Rate (%)|-4.2|STANDARD_ERROR_OF_MEAN|5.4|||TWO_SIDED|95.0|-14.8|6.35|||||Comparison: SAIT101 versus MabThera.|Adjusted Difference Rate (%) in Overall Response Rate (ORR) of SAIT101 versus MabThera at Week 28.||6.35|-14.80|
72341582|NCT02809053|144207060|OTHER|The 95%CI (confidence interval) for the difference in the overall response rate (ORR) was calculated using the Newcombe-Wilson method based on CMH (Cochran-Mantel-Haenszel) weight with stratification factor FLIPI-2 (low, intermediate and high risk).|Adjusted Difference Rate|-10.3|STANDARD_ERROR_OF_MEAN|5.42|||TWO_SIDED|95.0|-20.92|0.61|||||Comparison: SAIT101 versus MabThera|Adjusted Difference Rate of Overall Response Rate (ORR) of SAIT101 versus MabThera at Week 12.||0.61|-20.92|
72370053|NCT02105961|144250544|SUPERIORITY||Mean difference(Mepolizumab 300-Placebo)|-0.1||||0.926|TWO_SIDED|95.0|-2.8|2.6||Unadjusted p-value|Mixed Model Repeated Measures Analysis||Analysis performed using mixed model repeated measures with covariates of Baseline SGRQ total score, geographic region, smoking status, treatment and visit, plus interaction terms for visit by Baseline and visit by treatment group.|||2.6|-2.8|0.926
72428571|NCT03844321|144368163|SUPERIORITY||Difference in Slopes|-0.02||||0.488|TWO_SIDED|95.0|-0.06|0.03||A two-sided significance level of .05 was used.|Mixed Models Analysis|df = 1560|Slope estimate = difference in slopes between conditions (Mindfulness Light vs. Mindfulness-Based Cognitive Therapy) during time frame.|As with the primary outcome, we used a linear mixed effects model to examine the difference in effect of time on weekly PROMIS: Ability to Participate in Social Roles and Activities Short Form scores (reverse scored) in Mindfulness Light vs. Mindfulness-Based Cognitive Therapy conditions from baseline to 8 weeks.||0.03|-0.06|.488
72428572|NCT03844321|144368163|SUPERIORITY||Difference in Slopes|0.01||||0.446|TWO_SIDED|95.0|-0.01|0.03||A two-sided significance level of .05 was used.|Mixed Models Analysis|df = 1179|Slope estimate = difference in slopes between conditions (Mindfulness Light vs. Mindfulness-Based Cognitive Therapy) during time frame.|As with the primary outcome, we used a linear mixed effects model to examine the difference in effect of time on weekly PROMIS: Ability to Participate in Social Roles and Activities Short Form scores (reverse scored) in Mindfulness Light vs. Mindfulness-Based Cognitive Therapy conditions from baseline to 20 weeks.||0.03|-0.01|.446
72428573|NCT03844321|144368164|SUPERIORITY||Difference in Slopes|-0.04||||0.469|TWO_SIDED|95.0|-0.16|0.07||A two-sided significance level of .05 was used.|Mixed Models Analysis|df = 1618|Slope estimate = difference in slopes between conditions (Mindfulness Light vs. Mindfulness-Based Cognitive Therapy) during time frame.|As with the primary outcome, we used a linear mixed effects model to examine the difference in effect of time on weekly FFMQ scores in Mindfulness Light vs. Mindfulness-Based Cognitive Therapy conditions from baseline to 8 weeks.||0.07|-0.16|.469
72428574|NCT03844321|144368164|SUPERIORITY||Difference in Slopes|-0.06||||0.033|TWO_SIDED|95.0|-0.11|-0.01||A two-sided significance level of .05 was used.|Mixed Models Analysis|df = 1067|Slope estimate = difference in slopes between conditions (Mindfulness Light vs. Mindfulness-Based Cognitive Therapy) during time frame.|As with the primary outcome, we used linear mixed effects models to examine the effect of time on weekly FFMQ scores across both intervention conditions from baseline to 20 weeks.||-0.01|-0.11|.033
72428575|NCT03844321|144368165|SUPERIORITY|||||||0.046||||||Reported p-value is for estimated weekly change in WHO-5 score by treatment by moderator interaction.|Mixed Models Analysis|||Age measured at the beginning of the intervention period was analyzed as a moderator of the relationship between treatment and weekly WHO-5 scores. We added a main effect for the moderator, as well as treatment by time, moderator by time, and treatment by moderator by time interactions to the linear mixed model and used a likelihood ratio test to compare this interaction model to one without the three-way interaction. These analyses were completed over Baseline to Week 8.||||.046
72428576|NCT03844321|144368165|SUPERIORITY|||||||0.275||||||Reported p-value is for estimated weekly change in WHO-5 score by treatment by moderator interaction.|Mixed Models Analysis|||Age measured at the beginning of the intervention period was analyzed as a moderator of the relationship between treatment and weekly WHO-5 scores. We added a main effect for the moderator, as well as treatment by time, moderator by time, and treatment by moderator by time interactions to the linear mixed model and used a likelihood ratio test to compare this interaction model to one without the three-way interaction. These analyses were completed over Baseline to Week 20.||||.275
72428577|NCT03844321|144368166|SUPERIORITY|||||||0.977||||||Reported p-value is for estimated weekly change in WHO-5 score by treatment by moderator interaction.|Mixed Models Analysis|||PSS measured at the beginning of the intervention period was analyzed as a moderator of the relationship between treatment and weekly WHO-5 scores. We added a main effect for the moderator, as well as treatment by time, moderator by time, and treatment by moderator by time interactions to the linear mixed model and used a likelihood ratio test to compare this interaction model to one without the three-way interaction. These analyses were completed over Baseline to Week 8.||||.977
72341583|NCT02809053|144207065|OTHER|The estimated Hazard Ratio with 95% CI was obtained from Cox regression model; however, stratification factors, ie, FLIPI-2 (low, intermediate and high risk), were only taken into account if FLIPI-2 score=all.|Hazard Ratio (HR)|1.724|||||TWO_SIDED|95.0|0.853|3.482|||||Hazard Ration of TTE SAIT101:MabThera|Time to Event (TTE) Hazard Ratio (HR) of SAIT101:MabThera. The TTE is defined as the time from the date of randomization to the date when an event occurs; an event is disease progression as assessed by Investigator, death due to any cause, or the start of new treatment, whichever comes first.||3.482|0.853|
72341584|NCT02809053|144207066|EQUIVALENCE|Standard acceptance limits for bioequivalence (80.00% to 125.00%).|GLS Mean Difference (%)|101.39|||||TWO_SIDED|90.0|95.86|107.24|||||Comparison: SAIT101 versus MabThera. Equivalence was demonstrated for SAIT101 and MabThera with exposure pharmacokinetic parameter AUC0-168,w1 within the standard acceptance limits for bioequivalence (80.00% to 125.00%).|Statistical Comparison: geometric least square (GLS) Mean Ratio (90% Confidence Interval (CI)) (%) of SAIT101 versus MabThera Area Under the Concentration time Curve Day 0 to Week 1 (AUC0-168,w1) (h×µg/mL). The statistical comparison of the loge-transformed primary parameters between treatments is based on an analysis of variance model with fixed effect for treatment.||107.24|95.86|
72341585|NCT02809053|144207066|EQUIVALENCE|Standard acceptance limits for bioequivalence (80.00% to 125.00%).|GLS Mean Difference (%)|96.92|||||TWO_SIDED|90.0|90.85|103.4|||||Comparison: SAIT101 versus MabThera. Pharmacokinetic equivalence was demonstrated for SAIT101 and MabThera with exposure PK parameter AUC0-168,w4 within the standard acceptance limits for bioequivalence (80.00% to 125.00%).|Statistical Comparison: geometric least square (GLS) Mean Ratio (90% Confidence Interval (CI)) %) of SAIT101 versus MabThera Area Under the Concentration time Cure Day 0 to Week 4 (AUC0-168,w4) (h×µg/mL). The statistical comparison of the loge-transformed primary parameters between treatments is based on an analysis of variance model with fixed effect for treatment.||103.40|90.85|
72428578|NCT03844321|144368166|SUPERIORITY|||||||0.341||||||Reported p-value is for estimated weekly change in WHO-5 score by treatment by moderator interaction.|Mixed Models Analysis|||PSS measured at the beginning of the intervention period was analyzed as a moderator of the relationship between treatment and weekly WHO-5 scores. We added a main effect for the moderator, as well as treatment by time, moderator by time, and treatment by moderator by time interactions to the linear mixed model and used a likelihood ratio test to compare this interaction model to one without the three-way interaction. These analyses were completed over Baseline to Week 20.||||.341
72428579|NCT03844321|144368167|SUPERIORITY|||||||0.885||||||Reported p-value is for estimated weekly change in WHO-5 score by treatment by moderator interaction.|Mixed Models Analysis|||PROMIS: EDD measured at the beginning of the intervention period was analyzed as a moderator of the relationship between treatment and weekly WHO-5 scores. We added a main effect for the moderator, as well as treatment by time, moderator by time, and treatment by moderator by time interactions to the linear mixed model and used a likelihood ratio test to compare this interaction model to one without the three-way interaction. These analyses were completed over Baseline to Week 8.||||.885
72428580|NCT03844321|144368167|SUPERIORITY|||||||0.319||||||Reported p-value is for estimated weekly change in WHO-5 score by treatment by moderator interaction.|Mixed Models Analysis|||PROMIS: EDD measured at the beginning of the intervention period was analyzed as a moderator of the relationship between treatment and weekly WHO-5 scores. We added a main effect for the moderator, as well as treatment by time, moderator by time, and treatment by moderator by time interactions to the linear mixed model and used a likelihood ratio test to compare this interaction model to one without the three-way interaction. These analyses were completed over Baseline to Week 20.||||.319
72428581|NCT03844321|144368168|SUPERIORITY|||||||0.838||||||Reported p-value is for estimated weekly change in WHO-5 score by treatment by moderator interaction.|Mixed Models Analysis|||PROMIS: EDA measured at the beginning of the intervention period was analyzed as a moderator of the relationship between treatment and weekly WHO-5 scores. We added a main effect for the moderator, as well as treatment by time, moderator by time, and treatment by moderator by time interactions to the linear mixed model and used a likelihood ratio test to compare this interaction model to one without the three-way interaction. These analyses were completed over Baseline to Week 8.||||.838
72428582|NCT03844321|144368168|SUPERIORITY|||||||0.89||||||Reported p-value is for estimated weekly change in WHO-5 score by treatment by moderator interaction.|Mixed Models Analysis|||PROMIS: EDA measured at the beginning of the intervention period was analyzed as a moderator of the relationship between treatment and weekly WHO-5 scores. We added a main effect for the moderator, as well as treatment by time, moderator by time, and treatment by moderator by time interactions to the linear mixed model and used a likelihood ratio test to compare this interaction model to one without the three-way interaction. These analyses were completed over Baseline to Week 20.||||.890
72428583|NCT03844321|144368169|SUPERIORITY|||||||0.425||||||Reported p-value is for estimated weekly change in WHO-5 score by treatment by moderator interaction.|Mixed Models Analysis|||PROMIS: APRA measured at the beginning of the intervention period was analyzed as a moderator of the relationship between treatment and weekly WHO-5 scores. We added a main effect for the moderator, as well as treatment by time, moderator by time, and treatment by moderator by time interactions to the linear mixed model and used a likelihood ratio test to compare this interaction model to one without the three-way interaction. These analyses were completed over Baseline to Week 8.||||.425
72428584|NCT03844321|144368169|SUPERIORITY|||||||0.733||||||Reported p-value is for estimated weekly change in WHO-5 score by treatment by moderator interaction.|Mixed Models Analysis|||PROMIS: APRA measured at the beginning of the intervention period was analyzed as a moderator of the relationship between treatment and weekly WHO-5 scores. We added a main effect for the moderator, as well as treatment by time, moderator by time, and treatment by moderator by time interactions to the linear mixed model and used a likelihood ratio test to compare this interaction model to one without the three-way interaction. These analyses were completed over Baseline to Week 20.||||.733
72428585|NCT03844321|144368170|SUPERIORITY|||||||0.582||||||Reported p-value is for estimated weekly change in WHO-5 score by treatment by moderator interaction.|Mixed Models Analysis|||FFMQ measured at the beginning of the intervention period was analyzed as a moderator of the relationship between treatment and weekly WHO-5 scores. We added a main effect for the moderator, as well as treatment by time, moderator by time, and treatment by moderator by time interactions to the linear mixed model and used a likelihood ratio test to compare this interaction model to one without the three-way interaction. These analyses were completed over Baseline to Week 8.||||.582
72428586|NCT03844321|144368170|SUPERIORITY|||||||0.666||||||Reported p-value is for estimated weekly change in WHO-5 score by treatment by moderator interaction.|Mixed Models Analysis|||FFMQ measured at the beginning of the intervention period was analyzed as a moderator of the relationship between treatment and weekly WHO-5 scores. We added a main effect for the moderator, as well as treatment by time, moderator by time, and treatment by moderator by time interactions to the linear mixed model and used a likelihood ratio test to compare this interaction model to one without the three-way interaction. These analyses were completed over Baseline to Week 20.||||.666
72428587|NCT03844321|144368171|SUPERIORITY|||||||0.355||||||Reported p-value is for estimated weekly change in WHO-5 score by treatment by moderator interaction.|Mixed Models Analysis|||Presence of psychiatric illness at the beginning of the intervention period was analyzed as a moderator of the relationship between treatment and weekly WHO-5 scores. We added a main effect for the moderator, as well as treatment by time, moderator by time, and treatment by moderator by time interactions to the linear mixed model and used a likelihood ratio test to compare this interaction model to one without the three-way interaction. These analyses were completed over Baseline to Week 8.||||.355
72428588|NCT03844321|144368171|SUPERIORITY|||||||0.361||||||Reported p-value is for estimated weekly change in WHO-5 score by treatment by moderator interaction.|Mixed Models Analysis|||Presence of psychiatric illness at the beginning of the intervention period was analyzed as a moderator of the relationship between treatment and weekly WHO-5 scores. We added a main effect for the moderator, as well as treatment by time, moderator by time, and treatment by moderator by time interactions to the linear mixed model and used a likelihood ratio test to compare this interaction model to one without the three-way interaction. These analyses were completed over Baseline to Week 20.||||.361
72341586|NCT02809053|144207067|EQUIVALENCE|Standard acceptance limits for bioequivalence (80.00% to 125.00|GLS Mean Ratio (%)|99.35|||||TWO_SIDED|90.0|90.85|103.4|||||Comparison: SAIT101 versus MabThera. Pharmacokinetic equivalence was demonstrated for SAIT101 and MabThera with Cmax,w1 exposure within the standard acceptance limits for bioequivalence (80.00% to 125.00%).|Statistical Comparison: geometric least square (GLS) Mean Ratio (90% CI) (%) of SAIT101 versus MabThera maximum plasma concentration at Week 1 (Cmax,w1) (h×µg/mL). The statistical comparison of the loge-transformed primary parameters between treatments is based on an analysis of variance model with fixed effect for treatment.||103.40|90.85|
72341587|NCT02809053|144207067|EQUIVALENCE|Standard acceptance limits for bioequivalence (80.00% to 125.00%).|GLS Mean Ration (%)|99.23|||||TWO_SIDED|90.0|92.96|105.92|||||Comparison: SAIT101 versus MabThera. Pharmacokinetic equivalence was demonstrated for SAIT101 and MabThera with exposure PK parameter Cmax,w4 within the standard acceptance limits for bioequivalence (80.00% to 125.00%).|Statistical Comparison: geometric least square (GLS) Mean Ratio (90% CI) (%) of SAIT101 versus MabThera maximum plasma concentration at Week 4 (Cmax,w1) (h×µg/mL). The statistical comparison of the loge-transformed primary parameters between treatments is based on an analysis of variance model with fixed effect for treatment||105.92|92.96|
72428589|NCT03844321|144368172|SUPERIORITY|||||||0.64||||||Reported p-value is for estimated weekly change in WHO-5 score by treatment by moderator interaction.|Mixed Models Analysis|||Presence of medical problems at the beginning of the intervention period was analyzed as a moderator of the relationship between treatment and weekly WHO-5 scores. We added a main effect for the moderator, as well as treatment by time, moderator by time, and treatment by moderator by time interactions to the linear mixed model and used a likelihood ratio test to compare this interaction model to one without the three-way interaction. These analyses were completed over Baseline to Week 8.||||.640
72428590|NCT03844321|144368172|SUPERIORITY|||||||0.396||||||Reported p-value is for estimated weekly change in WHO-5 score by treatment by moderator interaction.|Mixed Models Analysis|||Presence of medical problems at the beginning of the intervention period was analyzed as a moderator of the relationship between treatment and weekly WHO-5 scores. We added a main effect for the moderator, as well as treatment by time, moderator by time, and treatment by moderator by time interactions to the linear mixed model and used a likelihood ratio test to compare this interaction model to one without the three-way interaction. These analyses were completed over Baseline to Week 20.||||.396
72428591|NCT03844321|144368173|SUPERIORITY|||||||0.004||||||Reported p-value is for estimated weekly change in WHO-5 score by treatment by moderator interaction.|Mixed Models Analysis|||Percentage of sessions completed was analyzed as a moderator of the relationship between treatment and weekly WHO-5 scores. We added a main effect for the moderator, as well as treatment by time, moderator by time, and treatment by moderator by time interactions to the linear mixed model and used a likelihood ratio test to compare this interaction model to one without the three-way interaction. These analyses were completed over Baseline to Week 8.||||.004
72428592|NCT03844321|144368173|SUPERIORITY|||||||0.291||||||Reported p-value is for estimated weekly change in WHO-5 score by treatment by moderator interaction.|Mixed Models Analysis|||Percentage of sessions completed was analyzed as a moderator of the relationship between treatment and weekly WHO-5 scores. We added a main effect for the moderator, as well as treatment by time, moderator by time, and treatment by moderator by time interactions to the linear mixed model and used a likelihood ratio test to compare this interaction model to one without the three-way interaction. These analyses were completed over Baseline to Week 20.||||.291
72428593|NCT03844321|144368174|SUPERIORITY|||||||0.603||||||Reported p-value is for estimated weekly change in WHO-5 score by treatment by moderator interaction.|Mixed Models Analysis|||Level of education was analyzed as a moderator of the relationship between treatment and weekly WHO-5 scores. We added a main effect for the moderator, as well as treatment by time, moderator by time, and treatment by moderator by time interactions to the linear mixed model and used a likelihood ratio test to compare this interaction model to one without the three-way interaction. These analyses were completed over Baseline to Week 8.||||.603
72428594|NCT03844321|144368174|SUPERIORITY|||||||0.333||||||Reported p-value is for estimated weekly change in WHO-5 score by treatment by moderator interaction.|Mixed Models Analysis|||Level of education was analyzed as a moderator of the relationship between treatment and weekly WHO-5 scores. We added a main effect for the moderator, as well as treatment by time, moderator by time, and treatment by moderator by time interactions to the linear mixed model and used a likelihood ratio test to compare this interaction model to one without the three-way interaction. These analyses were completed over Baseline to Week 20.||||.333
72428595|NCT03844321|144368175|SUPERIORITY|||||||0.224||||||Reported p-value is for estimated weekly change in WHO-5 score by treatment by moderator interaction.|Mixed Models Analysis|||Race was analyzed as a moderator of the relationship between treatment and weekly WHO-5 scores. We added a main effect for the moderator, as well as treatment by time, moderator by time, and treatment by moderator by time interactions to the linear mixed model and used a likelihood ratio test to compare this interaction model to one without the three-way interaction. These analyses were completed over Baseline to Week 20.||||.224
72428596|NCT03844321|144368175|SUPERIORITY|||||||0.885||||||Reported p-value is for estimated weekly change in WHO-5 score by treatment by moderator interaction.|Mixed Models Analysis|||Race was analyzed as a moderator of the relationship between treatment and weekly WHO-5 scores. We added a main effect for the moderator, as well as treatment by time, moderator by time, and treatment by moderator by time interactions to the linear mixed model and used a likelihood ratio test to compare this interaction model to one without the three-way interaction. These analyses were completed over Baseline to Week 20.||||.885
72341588|NCT02809053|144207070|EQUIVALENCE|Standard acceptance limits for bioequivalence (80.00% to 125.00%).|GLS Mean Ratio (%)|95.45|||||TWO_SIDED|90.0|88.85|102.55|||||Comparison: SAIT101 versus MabThera. Pharmacokinetic equivalence was demonstrated for SAIT101 and MabThera with exposure PK parameter Ctrough,d29 within the standard acceptance limits for bioequivalence (80.00% to 125.00%).|Statistical Comparison: geometric least square (GLS) Mean Ratio (90% CI) (%) of SAIT101 versus MabThera trough plasma concentration at the end of the dosing period (Day 29) (Ctrough,d29) (µg/mL) . The statistical comparison of the log-transformed primary parameters between treatments is based on an analysis of variance model with fixed effect for treatment||102.55|88.85|
72341589|NCT02809053|144207074|OTHER||Mean Difference (Final Values)|7.2|||||TWO_SIDED|90.0|-31.0|45.4|||||Comparison: SAIT101 versus MabThera|Statistical Comparison of CD19+ B-cell Pharmacodynamic Parameters (Pharmacodynamic Analysis Set). Area under the pharmacodynamic time effect curve from baseline (Time 0) to Week 1 (AUEC0-168,w1), normalized (cells/µL). The statistical comparison of the between treatments is based on an analysis of covariance (ANOVA) model with fixed effect for treatment and a covariate for baseline value.||45.4|-31.0|
72341590|NCT02809053|144207074|OTHER||Mean Difference (Final Values)|18.0|||||TWO_SIDED|90.0|-21.6|57.6|||||Comparison: SAIT101 versus MabThera.|Statistical Comparison of CD19+ B-cell Pharmacodynamic Parameters (Pharmacodynamic Analysis Set). Area under the pharmacodynamic time effect curve from baseline (Time 0) to Week 2 (AUEC0-168,w2), normalized (cells/µL). The statistical comparison of the between treatments is based on an analysis of covariance (ANOVA) model with fixed effect for treatment and a covariate for baseline value.||57.6|-21.6|
72341591|NCT02809053|144207074|OTHER||Mean Difference (Final Values)|21.4|||||TWO_SIDED|90.0|-18.3|61.0|||||Comparison: SAIT101 versus MabThera.|Statistical Comparison of CD19+ B-cell Pharmacodynamic Parameters (Pharmacodynamic Analysis Set). Area under the pharmacodynamic time effect curve from baseline (Time 0) to Week 3 (AUEC0-168,w3), normalized (cells/µL). The statistical comparison of the between treatments is based on an analysis of covariance (ANOVA) model with fixed effect for treatment and a covariate for baseline value.||61.0|-18.3|
72341592|NCT02809053|144207074|OTHER||Mean Difference (Final Values)|20.4|||||TWO_SIDED|90.0|-19.3|60.2|||||comparison: SAIT101 versus MabThera|Statistical Comparison of CD19+ B-cell Pharmacodynamic Parameters (Pharmacodynamic Analysis Set). Area under the pharmacodynamic time effect curve from baseline (Time 0) to Week 4 (AUEC0-168,w4), normalized (cells/µL). The statistical comparison of the between treatments is based on an analysis of covariance (ANOVA) model with fixed effect for treatment and a covariate for baseline value.||60.2|-19.3|
72341593|NCT02809053|144207074|OTHER||Mean Difference (Final Values)|15.7|||||TWO_SIDED|90.0|-23.1|54.6|||||Comparison: SAIT101 versus MabThera|Statistical Comparison of CD19+ B-cell Pharmacodynamic Parameters (Pharmacodynamic Analysis Set). Area under the pharmacodynamic time effect curve from baseline (Time 0) to Week 12 (AUEC0-168,w12), normalized (cells/µL). The statistical comparison of the between treatments is based on an analysis of covariance (ANOVA) model with fixed effect for treatment and a covariate for baseline value.||54.6|-23.1|
72341594|NCT02809053|144207074|OTHER||Mean Difference (Final Values)|12.8|||||TWO_SIDED|90.0|-26.0|51.8|||||Comparison: SAIT101 versus MabThera.|Statistical Comparison of CD19+ B-cell Pharmacodynamic Parameters (Pharmacodynamic Analysis Set). Area under the pharmacodynamic time effect curve from baseline (Time 0) to Week 28 (AUEC0-168,w28), normalized (cells/µL). The statistical comparison of the between treatments is based on an analysis of covariance (ANOVA) model with fixed effect for treatment and a covariate for baseline value.||51.8|-26.0|
72341595|NCT02809053|144207078|OTHER|||||||0.587||||||The p-value was calculated using Gail-Simon Test for Qualitative Interactions.|Gail-Simon|||Exploratory statistical analysis: Comparison of Overall Response Rate (ORR) by Region (European Union / Other). The interaction p-value for the Region subgroup was calculated based upon the full set of data, and based on a Cochran Mantel Haenszel (CMH) model including treatment, and applicable stratification covariate.||||0.587
72341596|NCT02809053|144207078|OTHER|||||||0.421||||||The p-value was calculated using Gail-Simon Test for Qualitative Interactions.|Gail-Simon|||Exploratory statistical analysis. Overall Response Rate by Age Group (18-60 years and \>60 years). The interaction p-value for the Age subgroup was calculated based upon the full set of data, and based on a Cochran Mantel Haenszel (CMH) model including treatment, and applicable stratification covariate.||||0.421
72341597|NCT02809053|144207078|OTHER|||||||0.288||||||The p-value was calculated using Gail-Simon Test for Qualitative Interactions.|Gail-Simon|||Exploratory statistical analysis. Comparison of Overall Response Rate (ORR) by Gender (Male / Female). The interaction p-value for the Gender subgroup was calculated based upon the full set of data, and based on a Cochran Mantel Haenszel (CMH) model including treatment, and applicable stratification covariate. The p-value was calculated using Gail-Simon Test for Qualitative Interactions.||||0.288
72341598|NCT02809053|144207078|OTHER|||||||0.588||||||The p-value was calculated using Gail-Simon Test for Qualitative Interactions.|Gail-Wilson|||Exploratory statistical analysis. Comparison of Overall Response Rate (ORR) by Anti-drug Antibody (ADA) status (Positive / Negative). The interaction p-value for the ADA subgroup was calculated based upon the full set of data, and based on a Cochran Mantel Haenszel (CMH) model including treatment, and applicable stratification covariate.||||0.588
72341599|NCT01177969|144207086|SUPERIORITY_OR_OTHER|||||||0.04||||||This analysis applies to the post-treatment assessment (16 weeks after baseline)|ANCOVA|||||||.04
72341600|NCT01177969|144207087|SUPERIORITY_OR_OTHER|||||||0.25||||||This analysis applies to the post-treatment assessment (16 weeks after baseline)|ANCOVA|||||||.25
72341601|NCT01852383|144207099|SUPERIORITY_OR_OTHER||||||<|0.001||||||Change from Week 0 to Week 12, not adjusted for multiple comparisons. Alpha=0.05 threshold for statistical significance.|ANCOVA|||||||<0.001
72341602|NCT01852383|144207100|SUPERIORITY_OR_OTHER||||||<|0.1||||||Change from Week 0 to Week 12, not adjusted for multiple comparisons. Alpha=0.05 threshold for statistical significance.|Corrlation|||||||<0.1
72341603|NCT01852383|144207101|SUPERIORITY_OR_OTHER||||||<|0.001||||||Change from Week 0 to Week 12, not adjusted for multiple comparisons. Alpha=0.05 threshold for statistical significance.|ANCOVA|||||||<0.001
72341604|NCT01852383|144207102|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|95.0||||Pearson correlation coefficient. Not adjusted for multiple comparisons. Alpha=0.05 for statistical significance threshold.|Pearson correlation|||Correlation of maximum duloxetine dose with change in Hamilton Depression Rating Scale scores from 0 Weeks to 12 Weeks.||||<.001
72341605|NCT00869401|144207189|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.79||||0.222|TWO_SIDED|95.0|0.54|1.16||Using Logrank Test|Log Rank|||||1.16|0.54|.222
72341606|NCT00869401|144207191|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.806||||0.183|TWO_SIDED|95.0|0.59|1.11|||Log Rank|||||1.11|0.59|0.183
72341607|NCT04881747|144207240|EQUIVALENCE|Model: Log(PK) = Treatment + Sequence + Period + Participant(Sequence) + Random Error, where participant within sequence is fitted as a random effect.|Ratio of Geometric least squares mean|0.875|||||TWO_SIDED|90.0|0.834|0.919||||||||0.919|0.834|
72341608|NCT04881747|144207240|EQUIVALENCE|Model: Log(PK) = Treatment + Sequence + Period + Participant(Sequence) + Random Error, where participant within sequence is fitted as a random effect.|Ratio of Geometric least squares mean|0.889|||||TWO_SIDED|90.0|0.846|0.934||||||||0.934|0.846|
72341609|NCT04881747|144207241|EQUIVALENCE|Model: Log(PK) = Treatment + Sequence + Period + Participant(Sequence) + Random Error, where participant within sequence is fitted as a random effect.|Ratio of Geometric least squares mean|0.944|||||TWO_SIDED|90.0|0.914|0.976||||||||0.976|0.914|
72341610|NCT04881747|144207241|EQUIVALENCE|Model: Log(PK) = Treatment + Sequence + Period + Participant(Sequence) + Random Error, where participant within sequence is fitted as a random effect.|Ratio of Geometric least squares mean|0.946|||||TWO_SIDED|90.0|0.914|0.978||||||||0.978|0.914|
72341611|NCT04881747|144207242|EQUIVALENCE|Model: Log(PK) = Treatment + Sequence + Period + Participant(Sequence) + Random Error, where participant within sequence is fitted as a random effect.|Ratio of Geometric least squares mean|0.941|||||TWO_SIDED|90.0|0.91|0.972||||||||0.972|0.910|
72341612|NCT04881747|144207242|EQUIVALENCE|Model: Log(PK) = Treatment + Sequence + Period + Participant(Sequence) + Random Error, where participant within sequence is fitted as a random effect.|Ratio of Geometric least squares mean|0.944|||||TWO_SIDED|90.0|0.913|0.977||||||||0.977|0.913|
72341613|NCT04598269|144207243|SUPERIORITY||Least Square Means (LSM) % Differences|-33.01|STANDARD_ERROR_OF_MEAN|8.971|<|0.001|TWO_SIDED|90.0|-47.95|-18.08||P-value is based on a 1-sided hypothesis test of the superiority of ATI-1777 relative to the vehicle. Significance level at α = 0.05.|Mixed Model Repeated Measures (MMRM)||"Fixed factors for treatment, visit, visit\*treatment, baseline measurement. A compound symmetry covariance matrix was used to account for within-subject variability.~Week 4: Least Square Means (LSM) % differences ATI-1777 arm minus vehicle arm"|||-18.08|-47.95|<0.001
72341614|NCT04598269|144207244|SUPERIORITY||LSM % Differences|-23.53|STANDARD_ERROR_OF_MEAN|8.971||0.005|TWO_SIDED|90.0|-38.47|-8.59||P-value is based on a 1-sided hypothesis test of the superiority of ATI-1777 relative to the vehicle. Significance level at α = 0.05.|MMRM||"Fixed factors for treatment, visit, visit\*treatment, baseline measurement. A compound symmetry covariance matrix was used to account for within-subject variability.~Day 8: LSM % differences ATI-1777 arm minus vehicle arm"|Day 8 statistical analysis||-8.59|-38.47|0.005
72341615|NCT04598269|144207244|SUPERIORITY||LSM % Differences|-23.44|STANDARD_ERROR_OF_MEAN|8.971||0.005|TWO_SIDED|90.0|-38.38|-8.5||P-value is based on a 1-sided hypothesis test of the superiority of ATI-1777 relative to the vehicle. Significance level at α = 0.05.|Mixed Models Analysis||"Fixed factors for treatment, visit, visit\*treatment, baseline measurement. A compound symmetry covariance matrix was used to account for within-subject variability.~Day 15: LSM % differences ATI-1777 arm minus vehicle arm"|Day 15 statistical analysis||-8.50|-38.38|0.005
72341616|NCT04598269|144207245|SUPERIORITY||Odds Ratio, log|15.7|||<|0.001|TWO_SIDED|90.0|3.9|63.2||1-sided p-value of responders in the treatment groups at 0.05 level of significance.|Regression, Logistic||Active/Vehicle|||63.2|3.9|<0.001
72341617|NCT04598269|144207246|SUPERIORITY||Odds Ratio, log|5.9||||0.003|TWO_SIDED|90.0|2.1|17.0||1-sided p-value of responders in the treatment groups at 0.05 level of significance|Regression, Linear||Active/Vehicle|||17.0|2.1|0.003
72341618|NCT04598269|144207247|SUPERIORITY||Odds Ratio, log|1.7||||0.203|TWO_SIDED|90.0|0.6|5.3||1-sided p-value of responders in the treatment groups at 0.05 level of significance|Regression, Logistic||Active/Vehicle|||5.3|0.6|0.203
72341619|NCT04598269|144207248|SUPERIORITY|||||||0.148||||||1-sided p-value of responders in the treatment groups at 0.05 level of significance|MMRM|||Day 8 statistical analysis||||0.148
72341620|NCT04598269|144207248|SUPERIORITY|||||||0.017||||||1-sided p-value of responders in the treatment groups at 0.05 level of significance|MMRM|||Day 15 statistical analysis||||0.017
72341621|NCT04598269|144207248|SUPERIORITY|||||||0.002||||||1-sided p-value of responders in the treatment groups at 0.05 level of significance|MMRM|||Week 4 statistical analysis||||0.002
72341622|NCT04598269|144207249|SUPERIORITY|||||||0.088||||||1-sided p-value of responders in the treatment groups at 0.05 level of significance|MMRM|||Day 8 statistical analysis||||0.088
72341623|NCT04598269|144207249|SUPERIORITY|||||||0.022||||||1-sided p-value of responders in the treatment groups at 0.05 level of significance|MMRM|||Day 15 statistical analysis||||0.022
72341624|NCT04598269|144207249|SUPERIORITY||||||<|0.001||||||1-sided p-value of responders in the treatment groups at 0.05 level of significance.|MMRM|||Week 4 statistical analysis||||<0.001
72341625|NCT04598269|144207250|SUPERIORITY|||||||0.014||||||1-sided p-value of responders in the treatment groups at 0.05 level of significance|MMRM|||Day 8 statistical analysis||||0.014
72341626|NCT04598269|144207250|SUPERIORITY|||||||0.069||||||1-sided p-value of responders in the treatment groups at 0.05 level of significance|MMRM|||Day 15 statistical analysis||||0.069
72341627|NCT04598269|144207250|SUPERIORITY|||||||0.06||||||1-sided p-value of responders in the treatment groups at 0.05 level of significance|MMRM|||Week 4 statistical analysis||||0.060
72341628|NCT03002454|144207251|EQUIVALENCE|"Control: 99mTc MDP Injection:fission Investigation: 99mTc MDP Injection:neutron-bombardment~Anticipated sample size of 50 participants with sample size parameters of:~Alpha 0.05 Power 80% Kappa of significance 0.7 - 0.8 Prevalence of abnormal bone scans 30%~Actual study population of 4 participants with 4 out of 4 demonstrating gross abnormal biodistribution therefore the study was terminated and no statistical analysis was conducted."|||||||||||||||||No statistical analysis - insufficient study population|||
72341629|NCT00552409|144207260|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.0|||||TWO_SIDED|95.0|-56.0|251.0|||Regression, Linear||Mean urine ACR on treatment was 17% lower among participants assigned to cholecalciferol, compared to participants assigned to placebo, adjusted for baseline values.|||251|-56|
72341630|NCT00849108|144207285|SUPERIORITY_OR_OTHER||sensitivity|0.769||||0.02|TWO_SIDED|95.0|0.655|0.884||P-Value for sensitivity comparison of PET MPI for the same reader|McNemar|two-sided McNemar test with 1 degree of freedom.|No standard deviation can be calculated for PET sensitivity|||0.884|0.655|0.02
72341631|NCT00849108|144207285|SUPERIORITY_OR_OTHER||Sensitivity|0.596||||0.02|TWO_SIDED|95.0|0.463|0.73||p-value for sensitivity comparison for SPECT MPI for the same reader|McNemar||No standard deviation can be calculated for SPECT sensitivity|||0.730|0.463|0.02
72341632|NCT00849108|144207287|SUPERIORITY_OR_OTHER||PET specificity|0.877||||0.317|TWO_SIDED|95.0|0.801|0.952||p-value for comparison of PET specificity for same reader|McNemar||no standard deviation for PET specficity|||0.952|0.801|0.317
72341633|NCT00849108|144207287|SUPERIORITY_OR_OTHER||SPECT specificity|0.836||||0.317|TWO_SIDED|95.0|0.751|0.921||p-value for comparison of SPECT specificity for same reader|McNemar||no standard deviation for SPECT specificity|||0.921|0.751|0.317
72341634|NCT03480009|144207288|OTHER|||||||0.2|||||||Wilcoxon (Mann-Whitney)|||||||.20
72341635|NCT03480009|144207288|OTHER|||||||0.2|||||||Wilcoxon (Mann-Whitney)|||||||.20
72341636|NCT03480009|144207289|OTHER|||||||0.81|||||||Wilcoxon (Mann-Whitney)|||Ibuprofen||||.81
72341637|NCT03480009|144207289|OTHER|||||||0.24|||||||Wilcoxon (Mann-Whitney)|||acetaminophen||||.24
72341638|NCT03480009|144207289|OTHER|||||||0.54|||||||Wilcoxon (Mann-Whitney)|||oxycodone||||.54
72341639|NCT03480009|144207289|OTHER|||||||0.61|||||||Wilcoxon (Mann-Whitney)|||Ibuprofen||||.61
72341640|NCT03480009|144207289|OTHER|||||||0.24|||||||Wilcoxon (Mann-Whitney)|||Acetaminophen||||.24
72341641|NCT03480009|144207290|OTHER|||||||0.99|||||||Wald Chi Square|Wald Chi Square from mixed effects linear regression||||||.99
72341642|NCT03480009|144207290|OTHER|||||||0.56|||||||Wald Chi Square|P-value from Wald chi-square from mixed effects linear regression||||||.56
72341643|NCT03480009|144207291|OTHER|||||||0.07|||||||Fisher Exact|||||||.07
72341644|NCT03480009|144207291|OTHER|||||||0.5|||||||Fisher Exact|||||||.50
72341645|NCT01563172|144207292|SUPERIORITY_OR_OTHER||Least square (LS) mean difference|6.95||||0.0008|TWO_SIDED|95.0|2.91|10.98||Between Treatment p-Values based on the statistical model adjusting for treatment, study period, and participant (random effect).|ANOVA||"LS Mean from Analysis of variance (ANOVA) with factors for treatment, study period, and participant (random effect).~Difference is first named treatment minus second named treatment such that a positive difference favours the first named treatment."|||10.98|2.91|0.0008
72341646|NCT01563172|144207293|SUPERIORITY_OR_OTHER||LS mean difference|5.7||||0.0049|TWO_SIDED|95.0|1.74|9.66||Between Treatment p-Values based on the statistical model adjusting for treatment, study period, and participant (random effect).|ANOVA||"LS Mean from ANOVA with factors for treatment, study period, and participant (random effect).~Difference is first named treatment minus second named treatment such that a positive difference favours the first named treatment."|||9.66|1.74|0.0049
72341647|NCT01563172|144207294|SUPERIORITY_OR_OTHER||LS mean difference|-10.86|||<|0.0001|TWO_SIDED|95.0|-14.77|-6.94||Between Treatment p-Values based on the statistical model adjusting for treatment, study period, and participant (random effect).|ANOVA||"LS Mean from ANOVA with factors for treatment, study period, and participant (random effect).~Difference is first named treatment minus second named treatment such that a positive difference favours the first named treatment."|||-6.94|-14.77|<0.0001
72341648|NCT01563172|144207295|SUPERIORITY_OR_OTHER||LS mean difference|-9.61|||<|0.0001|TWO_SIDED|95.0|-13.68|-5.54||Between Treatment p-Values based on the statistical model adjusting for treatment, study period, and participant (random effect).|ANOVA||"LS Mean from ANOVA with factors for treatment, study period, and participant (random effect).~Difference is first named treatment minus second named treatment such that a positive difference favours the first named treatment."|||-5.54|-13.68|<0.0001
72341649|NCT01563172|144207296|SUPERIORITY_OR_OTHER||LS mean difference|15.38|||<|0.0001|TWO_SIDED|95.0|11.45|19.31||Between Treatment p-Values based on the statistical model adjusting for treatment, study period, and participant (random effect).|ANOVA||"LS Mean from ANOVA with factors for treatment, study period, and participant (random effect).~Difference is first named treatment minus second named treatment such that a positive difference favours the first named treatment."|||19.31|11.45|<0.0001
72341650|NCT01563172|144207297|SUPERIORITY_OR_OTHER||LS Mean Difference|514.01|||<|0.0001|TWO_SIDED|95.0|283.02|744.99||Between Treatment p-Values based on the statistical model adjusting for treatment, study period, and participant (random effect).|ANOVA||"LS Mean from ANOVA with factors for treatment, study period, and participant (random effect).~Difference is first named treatment minus second named treatment such that a positive difference favours the first named treatment."|||744.99|283.02|<0.0001
72341651|NCT01563172|144207298|SUPERIORITY_OR_OTHER||LS Mean difference|265.92||||0.0218|TWO_SIDED|95.0|39.0|492.83||Between Treatment p-Values based on the statistical model adjusting for treatment, study period, and participant (random effect).|ANOVA||"LS Mean from ANOVA with factors for treatment, study period, and participant (random effect).~Difference is first named treatment minus second named treatment such that a positive difference favours the first named treatment."|||492.83|39.00|0.0218
72341652|NCT01563172|144207299|SUPERIORITY_OR_OTHER||LS mean difference|-822.88|||<|0.0001|TWO_SIDED|95.0|-1047.34|-598.42||Between Treatment p-Values based on the statistical model adjusting for treatment, study period, and participant (random effect).|ANOVA||"LS Mean from ANOVA with factors for treatment, study period, and participant (random effect).~Difference is first named treatment minus second named treatment such that a positive difference favours the first named treatment."|||-598.42|-1047.34|<0.0001
72341653|NCT01563172|144207300|SUPERIORITY_OR_OTHER||LS mean difference|-574.79|||<|0.0001|TWO_SIDED|95.0|-808.08|-341.5||Between Treatment p-Values based on the statistical model adjusting for treatment, study period, and participant (random effect).|ANOVA||"LS Mean from ANOVA with factors for treatment, study period, and participant (random effect).~Difference is first named treatment minus second named treatment such that a positive difference favours the first named treatment."|||-341.50|-808.08|<0.0001
72341654|NCT01563172|144207301|SUPERIORITY_OR_OTHER||LS mean difference|1294.34|||<|0.0001|TWO_SIDED|95.0|1069.24|1519.43||Between Treatment p-Values based on the statistical model adjusting for treatment, study period, and participant (random effect).|ANOVA||"LS Mean from ANOVA with factors for treatment, study period, and participant (random effect).~Difference is first named treatment minus second named treatment such that a positive difference favours the first named treatment."|||1519.43|1069.24|<0.0001
72341655|NCT02014584|144207324|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.0||||0.27|TWO_SIDED|95.0|-4.7|18.8|||Fisher's Exact Test|||||18.8|-4.7|0.27
72341656|NCT02014584|144207370|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-3.5||||0.62|TWO_SIDED|95.0|-10.4|3.4|||Fisher's Exact Test||DB Week 4|||3.4|-10.4|0.62
72341657|NCT02014584|144207370|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|6.4||||0.34|TWO_SIDED|95.0|-4.7|17.6|||Fisher's Exact Test||DB Week 12|||17.6|-4.7|0.34
72341658|NCT02014584|144207370|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|6.3||||0.31|TWO_SIDED|95.0|-4.2|16.7|||Fisher's Exact Test||DB Week 24|||16.7|-4.2|0.31
72428597|NCT03844321|144368176|SUPERIORITY|||||||0.49||||||Reported p-value is for estimated weekly change in WHO-5 score by treatment by moderator interaction.|Mixed Models Analysis|||Sex was analyzed as a moderator of the relationship between treatment and weekly WHO-5 scores. We added a main effect for the moderator, as well as treatment by time, moderator by time, and treatment by moderator by time interactions to the linear mixed model and used a likelihood ratio test to compare this interaction model to one without the three-way interaction. These analyses were completed over Baseline to Week 8.||||.490
72428598|NCT03844321|144368176|SUPERIORITY|||||||0.266||||||Reported p-value is for estimated weekly change in WHO-5 score by treatment by moderator interaction.|Mixed Models Analysis|||Sex was analyzed as a moderator of the relationship between treatment and weekly WHO-5 scores. We added a main effect for the moderator, as well as treatment by time, moderator by time, and treatment by moderator by time interactions to the linear mixed model and used a likelihood ratio test to compare this interaction model to one without the three-way interaction. These analyses were completed over Baseline to Week 20.||||.266
72341659|NCT02014584|144207372|SUPERIORITY_OR_OTHER||Adjusted mean difference|1.4|STANDARD_ERROR_OF_MEAN|0.8||0.082|TWO_SIDED|95.0|-0.2|3.0|||t-test from general linear model||DB Week 4|||3.0|-0.2|0.082
72341660|NCT02014584|144207372|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.3|STANDARD_ERROR_OF_MEAN|1.09||0.25|TWO_SIDED|95.0|-3.4|0.9|||t-test from general linear model||DB Week 12|||0.9|-3.4|0.25
72341661|NCT02014584|144207372|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.0|STANDARD_ERROR_OF_MEAN|1.04||0.99|TWO_SIDED|95.0|-2.0|2.1|||t-test from general linear model||DB Week 24|||2.1|-2.0|0.99
72341662|NCT02014584|144207374|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.2|STANDARD_ERROR_OF_MEAN|0.33||0.46|TWO_SIDED|95.0|-0.4|0.9|||t-test from general linear model||Erectile Function DB Week 4|||0.9|-0.4|0.46
72428599|NCT03844321|144368177|SUPERIORITY|||||||0.928||||||Reported p-value is for estimated weekly change in WHO-5 score by treatment by moderator interaction.|Mixed Models Analysis|||Ethnicity was analyzed as a moderator of the relationship between treatment and weekly WHO-5 scores. We added a main effect for the moderator, as well as treatment by time, moderator by time, and treatment by moderator by time interactions to the linear mixed model and used a likelihood ratio test to compare this interaction model to one without the three-way interaction. These analyses were completed over Baseline to Week 8.||||.928
72428600|NCT03844321|144368177|SUPERIORITY|||||||0.307||||||Reported p-value is for estimated weekly change in WHO-5 score by treatment by moderator interaction.|Mixed Models Analysis|||Ethnicity was analyzed as a moderator of the relationship between treatment and weekly WHO-5 scores. We added a main effect for the moderator, as well as treatment by time, moderator by time, and treatment by moderator by time interactions to the linear mixed model and used a likelihood ratio test to compare this interaction model to one without the three-way interaction. These analyses were completed over Baseline to Week 20.||||.307
72341663|NCT02014584|144207374|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.8|STANDARD_ERROR_OF_MEAN|0.52||0.14|TWO_SIDED|95.0|-1.8|0.3|||t-test from general linear model||Erectile Function DB Week 12|||0.3|-1.8|0.14
72341664|NCT02014584|144207374|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.7|STANDARD_ERROR_OF_MEAN|0.61||0.27|TWO_SIDED|95.0|-1.9|0.5|||t-test from general linear model||Erectile Function DB Week 24|||0.5|-1.9|0.27
72341665|NCT02014584|144207374|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.3|STANDARD_ERROR_OF_MEAN|0.23||0.13|TWO_SIDED|95.0|-0.1|0.8|||t-test from general linear model||Intercourse satisfaction DB Week 4|||0.8|-0.1|0.13
72341666|NCT02014584|144207374|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.33||0.73|TWO_SIDED|95.0|-0.8|0.5|||t-test from general linear model||Intercourse satisfaction DB Week 12|||0.5|-0.8|0.73
72341667|NCT02014584|144207374|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.34||0.64|TWO_SIDED|95.0|-0.8|0.5|||t-test from general linear model||Intercourse satisfaction DB Week 24|||0.5|-0.8|0.64
72341668|NCT02014584|144207374|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.2|STANDARD_ERROR_OF_MEAN|0.16||0.23|TWO_SIDED|95.0|-0.1|0.5|||t-test from general linear model||Orgasmic function DB Week 4|||0.5|-0.1|0.23
72341669|NCT02014584|144207374|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.15||0.33|TWO_SIDED|95.0|-0.5|0.2|||t-test from general linear model||Orgasmic function DB Week 12|||0.2|-0.5|0.33
72341670|NCT02014584|144207374|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.23||0.64|TWO_SIDED|95.0|-0.6|0.3|||t-test from general linear model||Orgasmic function DB Week 24|||0.3|-0.6|0.64
72341671|NCT02014584|144207374|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.3|STANDARD_ERROR_OF_MEAN|0.21||0.19|TWO_SIDED|95.0|-0.1|0.7|||t-test from general linear model||Sexual desire DB Week 4|||0.7|-0.1|0.19
72341672|NCT02014584|144207374|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.22||0.28|TWO_SIDED|95.0|-0.7|0.2|||t-test from general linear model||Sexual desire DB Week 12|||0.2|-0.7|0.28
72341673|NCT02014584|144207374|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.27||1|TWO_SIDED|95.0|-0.5|0.5|||t-test from general linear model||Sexual desire DB Week 24|||0.5|-0.5|1.00
72341674|NCT02014584|144207374|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.2|STANDARD_ERROR_OF_MEAN|0.17||0.28|TWO_SIDED|95.0|-0.2|0.5|||t-test from general linear model||Overall sexual satisfaction DB Week 4|||0.5|-0.2|0.28
72341675|NCT02014584|144207374|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.2||0.64|TWO_SIDED|95.0|-0.5|0.3|||t-test from general linear model||Overall sexual satisfaction DB Week 12|||0.3|-0.5|0.64
72341676|NCT02014584|144207374|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.22||0.69|TWO_SIDED|95.0|-0.5|0.3|||t-test from general linear model||Overall sexual satisfaction DB Week 24|||0.3|-0.5|0.69
72341677|NCT02014584|144207376|SUPERIORITY_OR_OTHER||Adjusted mean difference|1.1|STANDARD_ERROR_OF_MEAN|1.14||0.33|TWO_SIDED|95.0|-1.1|3.4|||t-test from general linear model||DB Week 12|||3.4|-1.1|0.33
72341678|NCT02014584|144207376|SUPERIORITY_OR_OTHER||Adjusted mean difference|3.3|STANDARD_ERROR_OF_MEAN|1.14||0.004|TWO_SIDED|95.0|1.1|5.6|||t-test from general linear model||DB Week 24|||5.6|1.1|0.004
72341679|NCT02014584|144207378|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.51||0.22|TWO_SIDED|95.0|-1.7|0.4|||t-test from general linear model||DB Week 12|||0.4|-1.7|0.22
72341680|NCT02014584|144207378|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.76||0.5|TWO_SIDED|95.0|-2.0|1.0|||t-test from general linear model||DB Week 24|||1.0|-2.0|0.50
72341681|NCT00752726|144207388|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.263|STANDARD_ERROR_OF_MEAN|0.115||0.0244|TWO_SIDED|95.0|0.035|0.491||P-value was not adjusted for multiple comparisons.|ANCOVA|Mean change was adjusted for treatment, baseline VAT and center effect using an ANCOVA model.|Adjusted mean difference between Placebo group and Orlistat group was determined. For this primary analysis, only one statistical test was performed and therefore, no multiple comparison adjustment was done.|The null hypothesis considered no difference in the change from baseline to week 24 between the two treatment groups.||0.491|0.035|0.0244
72341682|NCT00752726|144207389|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.172|STANDARD_ERROR_OF_MEAN|0.0834||0.0415|TWO_SIDED|95.0|0.007|0.337||P-value was not adjusted for multiple comparisons.|ANCOVA|Mean change was adjusted for the treatment, baseline VAT and center effects using an ANCOVA model.|Adjusted mean difference between Placebo group and Orlistat group was determined.|The null hypothesis considered no difference in the change from baseline to week 12 between the two treatment groups.||0.337|0.007|0.0415
72341683|NCT00752726|144207390|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|1.99|STANDARD_ERROR_OF_MEAN|0.881||0.026|TWO_SIDED|95.0|0.25|3.74||P-value was not adjusted for multiple comparisons.|ANCOVA|Mean change was adjusted for the treatment, baseline weight and center effects, using an ANCOVA model.|Adjusted mean difference between Placebo group and Orlistat group was determined.|The null hypothesis considered no difference in the change from baseline to week 24 between the two treatment groups.||3.74|0.25|0.026
72341684|NCT00752726|144207391|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|1.642|STANDARD_ERROR_OF_MEAN|0.7174||0.0242|TWO_SIDED|95.0|0.219|3.065||P-value was not adjusted for multiple comparisons.|ANCOVA|Mean change was adjusted for the treatment, baseline total fat mass and center effects using an ANCOVA model.|Adjusted mean difference between placebo group and Orlistat group was determined.|The null hypothesis considered no difference in the change from baseline to week 24 between the two treatment groups.||3.065|0.219|0.0242
72341685|NCT00752726|144207392|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|1.47|STANDARD_ERROR_OF_MEAN|0.704||0.039|TWO_SIDED|95.0|0.07|2.87||P-value was not adjusted for multiple comparisons|ANCOVA|Mean was adjusted for the treatment, baseline total fat mass and center effects using an ANCOVA model.|Adjusted mean difference between placebo group and Orlistat group was evaluated.|The null hypothesis considered no difference in the change from baseline to week 24 between the two treatment groups.||2.87|0.07|0.039
72341686|NCT00752726|144207393|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|1.7|STANDARD_ERROR_OF_MEAN|0.974||0.085|TWO_SIDED|95.0|-0.24|3.63||P-value was not adjusted for multiple comparisons|ANCOVA|Mean change was adjusted for the treatment, baseline waist circumference and center effects, using an ANCOVA model.|Adjusted mean difference between Placebo group and Orlistat group was determined.|The null hypothesis considered no difference in the change from baseline to week 24 between the two treatment groups.||3.63|-0.24|0.085
72341687|NCT00752726|144207395|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.023|STANDARD_ERROR_OF_MEAN|0.0232||0.3235|TWO_SIDED|95.0|-0.069|0.023||P-value was not adjusted for multiple comparisons.|ANCOVA|Mean change was adjusted for the treatment, baseline liver fat and center effects, using an ANCOVA model.|Adjusted mean difference between placebo group and Orlistat group was evaluated.|The null hypothesis considered no difference in the change from baseline to week 24 between the two treatment groups.||0.023|-0.069|0.3235
72341688|NCT00752726|144207396|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|783.8|STANDARD_ERROR_OF_MEAN|726.54||0.28|TWO_SIDED|95.0|-657.3|2224.9||P-value was not adjusted for multiple comparisons|ANCOVA|Mean change was adjusted for the treatment, baseline total calories expended and center effects using an ANCOVA model.|Adjusted mean difference between placebo group and Orlistat group was evaluated.|The null hypothesis considered no difference in the change from baseline to week 24 between the two treatment groups.||2224.9|-657.3|0.28
72341689|NCT00752726|144207397|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|1.66|STANDARD_ERROR_OF_MEAN|1.542||0.2847|TWO_SIDED|95.0|-1.4|4.72||P-value was not adjusted for multiple comparisons.|ANCOVA|Mean difference was adjusted for the treatment, baseline value and center effects using an ANCOVA model.|Adjusted mean difference was calculated as placebo minus orlistat.|The null hypothesis considered no difference in the change from baseline to week 24 between the treatment groups.||4.72|-1.40|0.2847
72341690|NCT04232215|144207406|SUPERIORITY||Mean Difference (Final Values)|-2.0||||0.64|TWO_SIDED|95.0|-10.2|6.1|||Regression, Linear|A generalized linear model adjusting by intervention group and the order of randomization was conducted.||Difference in ease of use between our standard fetal Doppler and HeraBEAT™ device, as measured by the System Usability Survey (SUS) will be the primary outcome. We aim to recruit 50 participants (50 per arm, with cross-over) for a 99.7% power to detect a 10-point difference in SUS, as this accounts for a withdraw / post-randomization exclusion as high as 10% (assuming a proportion of expectant mothers to withdraw participation after being enrolled or found to not meet criteria after the fact).||6.1|-10.2|0.64
72341691|NCT04232215|144207407|SUPERIORITY||Risk Ratio (RR)|1.2||||0.63|TWO_SIDED|95.0|0.57|2.53|||Chi-squared|||||2.53|0.57|0.63
72341692|NCT01555125|144207418|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Fisher Exact|||||||<0.0001
72341693|NCT01555125|144207418|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Fisher Exact|||||||<0.0001
72341694|NCT01555125|144207419|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Fisher Exact|||||||<0.0001
72341695|NCT01555125|144207419|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Fisher Exact|||||||<0.0001
72341696|NCT02651220|144207441|EQUIVALENCE|Bioequivalence was based on 90% confidence interval within 80-125%.|Bioavailability|100.28|||||TWO_SIDED|90.0|96.78|103.91||||||||103.91|96.78|
72341697|NCT02651220|144207442|EQUIVALENCE|Bioequivalence is based on 90% confidence interval within 80-125%.|Bioavailability|99.73|||||TWO_SIDED|90.0|96.04|103.56||||||||103.56|96.04|
72341698|NCT02651220|144207443|SUPERIORITY||||||<|0.0001|||||||ANOVA|||||||<0.0001
72341699|NCT00896441|144207444|SUPERIORITY_OR_OTHER||||||<|0.01|||||||t-test, 2 sided|One sample t-test||||||<0.01
72341700|NCT00896441|144207446|OTHER||||||<|0.006|||||||t-test, 2 sided|Single group t-test||||||<.006
72341701|NCT01304589|144207447|SUPERIORITY_OR_OTHER|||||||0.001||||||A paired T-Test was calculated assuming a standard difference (d) between the 4 paired outcomes for pain of 0.60 (moderate effect size), a SD of 1 for each outcome variable and a correlation of 0.50 between each paired variable.|t-test, 2 sided|||||||.001
72341702|NCT01304589|144207448|SUPERIORITY_OR_OTHER|||||||0.003||||||A paired T-Test was calculated assuming a standard difference (d) between the 4 paired outcomes for pain of 0.60 (moderate effect size), a SD of 1 for each outcome variable and a correlation of 0.50 between each paired variable.|paired T-test|"Subjects completed a tampon insertion pain test once a week. The values were averaged and compared pre-treatment versus post-treatment."||||||.003
72341703|NCT01304589|144207449|SUPERIORITY_OR_OTHER|||||||0.001||||||A paired T-Test was calculated assuming a standard difference (d) between the 4 paired outcomes for pain of 0.60 (moderate effect size), a SD of 1 for each outcome variable and a correlation of 0.50 between each paired variable.|t-test, 2 sided|||||||.001
72341704|NCT01304589|144207450|SUPERIORITY_OR_OTHER||||||<|0.001||||||A paired T-Test was calculated assuming a standard difference (d) between the 4 paired outcomes for pain of 0.60 (moderate effect size), a SD of 1 for each outcome variable and a correlation of 0.50 between each paired variable.|t-test, 2 sided|||||||<.001
72341705|NCT01078168|144207494|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3769||||0.0347|TWO_SIDED|95.0|0.03025|0.7235||threshold: p\<0.05|t-test, 2 sided|||||0.7235|0.03025|0.0347
72341706|NCT01280695|144207520|SUPERIORITY_OR_OTHER||Median Difference (Net)|-10.0||||0.4195|TWO_SIDED|95.0|-34.0|14.0|||Wilcoxon (Mann-Whitney)|||||14.0|-34.0|0.4195
72341707|NCT01280695|144207520|SUPERIORITY_OR_OTHER||Median Difference (Net)|-18.0||||0.0811|TWO_SIDED|95.0|-38.0|4.0|||Wilcoxon (Mann-Whitney)|||||4.0|-38.0|0.0811
72341708|NCT01280695|144207520|SUPERIORITY_OR_OTHER||Median Difference (Net)|-20.0||||0.0639|TWO_SIDED|95.0|-38.0|1.0|||Wilcoxon (Mann-Whitney)|||||1.0|-38.0|0.0639
72341709|NCT01280695|144207520|SUPERIORITY_OR_OTHER||Median Difference (Net)|-32.0||||0.0022|TWO_SIDED|95.0|-50.0|-12.0|||Wilcoxon (Mann-Whitney)|||||-12.0|-50.0|0.0022
72341710|NCT02720692|144207528|SUPERIORITY||||||<|0.05||||||P\<0.05 applies to Day 1 (0-24 Hours; p=0.0033), Days 1-2 (0-48 Hours; p=0.0077), and Days 1-3 (0-72 Hours; p=0.0152).|ANCOVA|||||||<0.05
72341711|NCT05011513|144207529|SUPERIORITY|||||||0.6027|||||||Log Rank|||||||0.6027
72341712|NCT05011513|144207531|SUPERIORITY|||||||0.1796||||||P-value reported for COVID-19 hospitalization and death due to any cause.|Normal approximation|||||||0.1796
72341713|NCT05011513|144207533|SUPERIORITY|||||||0.0971|||||||Negative binomial|||||||0.0971
72341714|NCT05011513|144207535|SUPERIORITY||Odds Ratio (OR)|0.819||||0.1622|TWO_SIDED|95.0|0.618|1.084|||Regression, Logistic|||Main effects of treatment, geographic region, baseline SARS-CoV-2 serology status and baseline viral load (\< 4 log10 copies/mL, \>= 4 log10 copies/mL).||1.084|0.618|0.1622
72341715|NCT05011513|144207536|SUPERIORITY|||||||0.4298|||||||Log Rank|||||||0.4298
72341716|NCT05011513|144207539|SUPERIORITY||Odds Ratio (OR)|0.802||||0.1086|TWO_SIDED|95.0|0.613|1.05|||Regression, Logistic|||Main effects of treatment, geographic region, symptom onset duration (\<=3, \>3), baseline SARS-CoV-2 serology status (positive/negative), vaccination status (complete/not vaccinated) and baseline viral load (\<4 log10 copies/mL, \>=4 log10 copies/mL).||1.050|0.613|0.1086
72341717|NCT05011513|144207540|SUPERIORITY||Odds Ratio (OR)|50.333||||0.3262|TWO_SIDED|95.0|13.163|192.472|||Breslow-Day Test|||||192.472|13.163|0.3262
72341718|NCT05011513|144207540|SUPERIORITY||Odds Ratio (OR)|22.224|||||TWO_SIDED|95.0|8.36|59.08||||||Odds ratio for Day 5 vs Day 1||59.080|8.360|
72341719|NCT03878758|144207544|SUPERIORITY|The average difference in incidence of needle bending with BD Nano vs. Comparator pen needle was calculated with 95% confidence interval and assessed for statistical significance.|Risk Difference (RD)|-0.39||||0.591|TWO_SIDED|95.0|-1.82|1.04|||Fisher Exact|||||1.04|-1.82|0.591
72341720|NCT03878758|144207544|SUPERIORITY|The average difference in percentage of occurrence with BD Nano vs. Comparator pen needle was calculated with 95% confidence interval and assessed for statistical significance.|Risk Difference (RD)|0.13||||0.931|TWO_SIDED|95.0|-2.8|3.06|||Fisher Exact|||||3.06|-2.8|0.931
72341721|NCT03878758|144207544|SUPERIORITY|The average difference in percentage of occurrence with BD Nano vs. Comparator pen needle was calculated with 95% confidence interval and assessed for statistical significance.|Risk Difference (RD)|0.42||||0.723|TWO_SIDED|95.0|-1.91|2.75|||Fisher Exact|||||2.75|-1.91|0.723
72341722|NCT03878758|144207545|SUPERIORITY|The average difference in percentage of occurrence with BD Nano vs. comparator was calculated with 95% confidence interval and assessed for statistical significance.|Risk Difference (RD)|-5.7|||<|0.001|TWO_SIDED|95.0|-9.0|-3.5|||Fisher Exact|||||-3.5|-9.0|<0.001
72341723|NCT03878758|144207545|SUPERIORITY|The average difference in percentage of occurrence with BD Nano vs. comparator was calculated with 95% confidence interval and assessed for statistical significance.|Risk Difference (RD)|-14.09||||0.026|TWO_SIDED|95.0|-26.49|-1.69||Although a site difference was detected - all sites combined p-value was generated,|Fisher Exact|||||-1.69|-26.49|0.026
72341724|NCT03878758|144207545|SUPERIORITY|The average difference in percentage of occurrence with BD Nano vs.Comparator pen needle was calculated with 95% confidence interval and assessed for statistical significance.|Risk Difference (RD)|-0.2||||0.644|TWO_SIDED|95.0|-1.9|0.6|||Fisher Exact|||||0.6|-1.9|0.644
72341725|NCT03878758|144207546|SUPERIORITY|Two-sided 95% confidence intervals is calculated for the average relative rating. A linear model was used to evaluate the pen needle group effect on the response to test whether the groups can be combined (a p-value \< 0.05 for the pen needle group effect indicates non-poolability) and to adjust for the order effect. The order of the pen needles used and the group to which the subject belongs were used as covariates.|Overall Mean|0.8|||||TWO_SIDED|95.0|0.62|0.98||||||||0.98|0.62|
72341726|NCT03878758|144207546|SUPERIORITY|Two-sided 95% confidence intervals is calculated for the average relative rating. A linear model was used to evaluate the pen needle group effect on the response to test whether the groups can be combined (a p-value \< 0.05 for the pen needle group effect indicates non-poolability) and to adjust for the order effect. The order of the pen needles used and the group to which the subject belongs were used as covariates.|Overall Mean|1.0|||||TWO_SIDED|95.0|0.8|1.16||||||||1.16|0.8|
72341727|NCT03878758|144207546|SUPERIORITY|Two-sided 95% confidence intervals is calculated for the average relative rating. A linear model was used to evaluate the pen needle group effect on the response to test whether the groups can be combined (a p-value \< 0.05 for the pen needle group effect indicates non-poolability) and to adjust for the order effect. The order of the pen needles used and the group to which the subject belongs were used as covariates.|Overall Mean|0.3|||||TWO_SIDED|95.0|0.13|0.49||||||||0.49|0.13|
72341728|NCT03878758|144207547|SUPERIORITY|A mixed effect model was used (fixed effects of PN, abdomen site, order of pair, order of PN within pair and random subject effect) to estimate average difference (BD Nano PN - Comparator PN) in delivery time and total injection time. A Box-Cox transformation might be used to normalize the data if necessary.|Mean Difference (Final Values)|-0.192|||<|0.001|ONE_SIDED|95.0||-0.141|||Mixed Models Analysis|||BD Nano Pro vs Artsana 34G||-0.141||<0.001
72341729|NCT03878758|144207547|SUPERIORITY|A mixed effect model was used (fixed effects of PN, abdomen site, order of pair, order of PN within pair and random subject effect) to estimate average difference (BD Nano PN - Comparator PN) in delivery time and total injection time. A Box-Cox transformation might be used to normalize the data if necessary.|Mean Difference (Final Values)|-0.122||||0.104|ONE_SIDED|95.0||0.016|||Mixed Models Analysis|||BD NANO vs Artsana 33G. A significant site effect was detected at one site; the most conservative p-value is reported.||0.016||0.104
72341730|NCT03878758|144207547|SUPERIORITY|A mixed effect model was used (fixed effects of PN, abdomen site, order of pair, order of PN within pair and random subject effect) to estimate average difference (BD Nano PN - Comparator PN) in delivery time and total injection time. A Box-Cox transformation might be used to normalize the data if necessary. The upper bound of the confidence interval was compared to 0.|Mean Difference (Net)|-0.068||||0.003|ONE_SIDED|95.0||-0.017|||Mixed Models Analysis|||BD NANO vs Comfort EZ 33G||-0.017||0.003
72341731|NCT03878758|144207548|SUPERIORITY|The number and proportion of needle breaking occurrence for each pen needle type were summarized. A 95% confidence interval for difference in proportions between BD Nano Pro and the Comparator was calculated using the score method for independent proportions.|Mean Difference (Final Values)|0.0|||||TWO_SIDED|95.0|-0.4|1.2||||||||1.2|-0.4|
72341732|NCT03878758|144207548|SUPERIORITY|The number and proportion of needle breaking occurrence for each pen needle type were summarized. A 95% confidence interval for difference in proportions between BD Nano Pro and the Comparator was calculated using the score method for independent proportions.|Mean Difference (Final Values)|0.0|||||TWO_SIDED|95.0|-0.4|1.2||||||||1.2|-0.4|
72341733|NCT03878758|144207548|SUPERIORITY|The number and proportion of needle breaking occurrence for each pen needle type were summarized. A 95% confidence interval for difference in proportions between BD Nano Pro and the Comparator was calculated using the score method for independent proportions.|Mean Difference (Final Values)|0.0|||||TWO_SIDED|95.0|-0.4|1.2||||||||1.2|-0.4|
72341734|NCT02100969|144207568|SUPERIORITY||"proportion of successes"|0.864||||0.0179|TWO_SIDED|95.0|0.72|1.0||No adjustment is required as we are not doing multiple comparisons for the primary outcome analyses.|One sample Z test of proportions||One sample Z test of proportions is used. Method of handling missing data (as per protocol) is Last Observation Carried Forward (LOCF). Only 2 participants had missing values and in our case the LOCF results reflect a 'best-case' scenario.|"Sample size/power calculations are mentioned in the study protocol.~The study hypotheses are as follows:~H0: Proportion of patients whose QMG scores are increased by no more than 3 points at the end of the SCIg treatment phase ≤ 0.65 HA: Proportion of patients whose QMG scores are increased by no more than 3 points at the end of the SCIg treatment phase \> 0.65"||1.000|0.720|0.0179
72341735|NCT02100969|144207569|SUPERIORITY||Median Difference (Net)|0.0||||0.113|TWO_SIDED||||||Wilcoxon Signed Rank for paired data||The value of the signed rank test statistic is 44.50.|||||0.113
72341736|NCT02100969|144207570|SUPERIORITY||Median Difference (Net)|6.0||||0.612|TWO_SIDED||||||Wilcoxon Signed Rank for paired data|||||||0.612
72341737|NCT02100969|144207571|SUPERIORITY||Median Difference (Net)|2.0||||0.047|TWO_SIDED||||||Wilcoxon Signed Rank for paired data||The value of the signed-rank test statistic is 53.|||||0.047
72341738|NCT02100969|144207572|SUPERIORITY||Median Difference (Net)|5.6||||0.901|TWO_SIDED||||||Wilcoxon Signed Rank for paired data|||||||0.901
72341739|NCT02100969|144207573|SUPERIORITY||Median Difference (Net)|4.2||||0.51|TWO_SIDED||||||Wilcoxon Signed Rank for paired data|||||||0.510
72341740|NCT02100969|144207574|SUPERIORITY||Median Difference (Net)|8.3||||0.289|TWO_SIDED||||||Wilcoxon Signed Rank for paired data|||||||0.289
72341741|NCT02100969|144207575|SUPERIORITY||Median Difference (Net)|715.0||||0.0028|TWO_SIDED||||||Wilcoxon Signed Rank for paired data|||||||0.0028
72341742|NCT06359080|144207579|EQUIVALENCE|The difference between post treatment CARS scores and pre treatment CARS scores will be statistically significant as measured by independent sample t-test with p\<.05|Mean Difference (Net)|6.77|STANDARD_DEVIATION|5.5|<|0.05|TWO_SIDED|95.0|5.36|8.19||It's a calculated p-value.|t-test, 2 sided|||||8.19|5.36|<0.05
72341743|NCT00448747|144207610|OTHER||ROC AUC|0.923|||||ONE_SIDED|99.0|0.85|||||||Summary of ROC Analyses following macimorelin administration.|||0.850|
72341744|NCT00448747|144207610|OTHER|Sensitivity|sensitivity (percent)|82.0|||||TWO_SIDED|||||||||ROC analysis on peak GH concentrations in response to macimorelin: GH cut point of 2.7 ng/mL.||||
72341745|NCT00448747|144207610|OTHER|Specificity|Specificity (percent)|92.0|||||TWO_SIDED|||||||||ROC analysis on peak GH concentrations in response to macimorelin: GH cut point of 2.7 ng/mL.||||
72341746|NCT00448747|144207610|OTHER|Misclassification|misclassification (percent)|13.0|||||TWO_SIDED|||||||||ROC analysis on peak GH concentrations in response to macimorelin: GH cut point of 2.7 ng/mL.||||
72341747|NCT00448747|144207611|OTHER||Mean Difference (Final Values)|-5.1|STANDARD_DEVIATION|9.57|||TWO_SIDED|||||||||Summary of IGF-1 before and after AEZS-130 administration: post - pre differences||||
72341748|NCT00448747|144207611|OTHER||Mean Difference (Final Values)|-2.3|STANDARD_DEVIATION|16.25|||TWO_SIDED|||||||||||||
72341749|NCT02905006|144207614|SUPERIORITY||||||<|0.0001||||||P-value evaluating dose response excludes the BKZ Dose 3 group; is based on a logistic regression model with fixed effects for region, prior biologic exposure, continuous treatment variable with values of -2, -1, 0, 1, 2 for the remaining groups.|Regression, Logistic|||||||<0.0001
72341750|NCT02905006|144207614|SUPERIORITY||||||<|0.0001||||||P-value evaluating dose response excludes the BKZ Dose 3 group; is based on a logistic regression model with fixed effects for region, prior biologic exposure, continuous treatment variable with values of -2, -1, 0, 1, 2 for the remaining groups.|Regression, Logistic|||||||<0.0001
72341751|NCT02905006|144207614|SUPERIORITY||||||<|0.0001||||||P-value evaluating dose response excludes the BKZ Dose 3 group; is based on a logistic regression model with fixed effects for region, prior biologic exposure, continuous treatment variable with values of -2, -1, 0, 1, 2 for the remaining groups.|Regression, Logistic|||||||<0.0001
72341752|NCT02905006|144207614|SUPERIORITY||||||<|0.0001||||||P-value evaluating dose response excludes the BKZ Dose 3 group; is based on a logistic regression model with fixed effects for region, prior biologic exposure, continuous treatment variable with values of -2, -1, 0, 1, 2 for the remaining groups.|Regression, Logistic|||||||<0.0001
72341753|NCT02905006|144207615|SUPERIORITY||Odds Ratio (OR)|21.43|||=|0.0001|TWO_SIDED|95.0|4.51|101.88|||Regression, Logistic|Confidence intervals, odds ratios, p-values derived from a logistic regression model with fixed effects for treatment, region, prior bio-exposure.||||101.88|4.51|=0.0001
72341754|NCT02905006|144207615|SUPERIORITY||Odds Ratio (OR)|63.21|||<|0.0001|TWO_SIDED|95.0|12.9|309.83|||Regression, Logistic|Confidence intervals, odds ratios, p-values derived from a logistic regression model with fixed effects for treatment, region, prior bio-exposure.||||309.83|12.90|<0.0001
72341755|NCT02905006|144207615|SUPERIORITY||Odds Ratio (OR)|62.35|||<|0.0001|TWO_SIDED|95.0|12.61|308.29|||Regression, Logistic|Confidence intervals, odds ratios, p-values derived from a logistic regression model with fixed effects for treatment, region, prior bio-exposure.||||308.29|12.61|<0.0001
72341756|NCT02905006|144207615|SUPERIORITY||Odds Ratio (OR)|130.35|||<|0.0001|TWO_SIDED|95.0|24.5|693.51|||Regression, Logistic|Confidence intervals, odds ratios, p-values derived from a logistic regression model with fixed effects for treatment, region, prior bio-exposure.||||693.51|24.50|<0.0001
72341757|NCT02905006|144207615|SUPERIORITY||Odds Ratio (OR)|69.4|||<|0.0001|TWO_SIDED|95.0|14.07|342.4|||Regression, Logistic|Confidence intervals, odds ratios, p-values derived from a logistic regression model with fixed effects for treatment, region, prior bio-exposure.||||342.40|14.07|<0.0001
72341758|NCT02905006|144207616|SUPERIORITY||Odds Ratio (OR)|18.23|||=|0.0003|TWO_SIDED|95.0|3.79|87.76|||Regression, Logistic|Confidence intervals, odds ratios, p-values derived from a logistic regression model with fixed effects for treatment, region, prior bio-exposure.||||87.76|3.79|=0.0003
72341759|NCT02905006|144207616|SUPERIORITY||Odds Ratio (OR)|39.6|||<|0.0001|TWO_SIDED|95.0|8.19|191.59|||Regression, Logistic|Confidence intervals, odds ratios, p-values derived from a logistic regression model with fixed effects for treatment, region, prior bio-exposure.||||191.59|8.19|<0.0001
72341760|NCT02905006|144207616|SUPERIORITY||Odds Ratio (OR)|77.27|||<|0.0001|TWO_SIDED|95.0|15.19|392.93|||Regression, Logistic|Confidence intervals, odds ratios, p-values derived from a logistic regression model with fixed effects for treatment, region, prior bio-exposure.||||392.93|15.19|<0.0001
72341761|NCT02905006|144207616|SUPERIORITY||Odds Ratio (OR)|141.99|||<|0.0001|TWO_SIDED|95.0|26.26|767.72|||Regression, Logistic|Confidence intervals, odds ratios, p-values derived from a logistic regression model with fixed effects for treatment, region, prior bio-exposure.||||767.72|26.26|<0.0001
72341762|NCT02905006|144207616|SUPERIORITY||Odds Ratio (OR)|58.52|||<|0.0001|TWO_SIDED|95.0|11.89|288.0|||Regression, Logistic|Confidence intervals, odds ratios, p-values derived from a logistic regression model with fixed effects for treatment, region, prior bio-exposure.||||288.00|11.89|<0.0001
72341763|NCT02905006|144207617|SUPERIORITY||||||<|0.0001||||||The placebo treatment group contained no PASI90 responders and as such the p-values for the pairwise comparisons are based upon the Fisher's exact test.|Fisher Exact|||||||<0.0001
72428601|NCT01374802|144368196|NON_INFERIORITY_OR_EQUIVALENCE|investigation of relative bioavailability (no formal testing)|Geometric Mean Ratio|115.29|STANDARD_DEVIATION|19.4|||TWO_SIDED|90.0|101.36|131.13|||ANOVA||the standard deviation is actually the geometric coefficient of variation|relative bioavailability comparison (Faldaprevir+DRV/r : DRV/r) of Darunavir||131.13|101.36|
72341764|NCT02905006|144207617|SUPERIORITY||||||<|0.0001||||||The placebo treatment group contained no PASI90 responders and as such the p-values for the pairwise comparisons are based upon the Fisher's exact test.|Fisher Exact|||||||<0.0001
72341765|NCT02905006|144207617|SUPERIORITY||||||<|0.0001||||||The placebo treatment group contained no PASI90 responders and as such the p-values for the pairwise comparisons are based upon the Fisher's exact test.|Fisher Exact|||||||<0.0001
72341766|NCT02905006|144207617|SUPERIORITY||||||<|0.0001||||||The placebo treatment group contained no PASI90 responders and as such the p-values for the pairwise comparisons are based upon the Fisher's exact test.|Fisher Exact|||||||<0.0001
72341767|NCT02905006|144207617|SUPERIORITY||||||<|0.0001||||||The placebo treatment group contained no PASI90 responders and as such the p-values for the pairwise comparisons are based upon the Fisher's exact test.|Fisher Exact|||||||<0.0001
72341768|NCT02905006|144207618|SUPERIORITY||Odds Ratio (OR)|32.65|||<|0.0001|TWO_SIDED|95.0|6.82|156.38|||Regression, Logistic|Confidence intervals, odds ratios, p-values derived from a logistic regression model with fixed effects for treatment, region, prior bio-exposure.||||156.38|6.82|<0.0001
72341769|NCT02905006|144207618|SUPERIORITY||Odds Ratio (OR)|94.51|||<|0.0001|TWO_SIDED|95.0|18.54|481.86|||Regression, Logistic|Confidence intervals, odds ratios, p-values derived from a logistic regression model with fixed effects for treatment, region, prior bio-exposure.||||481.86|18.54|<0.0001
72341770|NCT02905006|144207618|SUPERIORITY||Odds Ratio (OR)|117.66|||<|0.0001|TWO_SIDED|95.0|22.08|626.89|||Regression, Logistic|Confidence intervals, odds ratios, p-values derived from a logistic regression model with fixed effects for treatment, region, prior bio-exposure.||||626.89|22.08|<0.0001
72341771|NCT02905006|144207618|SUPERIORITY||Odds Ratio (OR)|280.76|||<|0.0001|TWO_SIDED|95.0|44.06|1789.24|||Regression, Logistic|Confidence intervals, odds ratios, p-values derived from a logistic regression model with fixed effects for treatment, region, prior bio-exposure.||||1789.24|44.06|<0.0001
72341772|NCT02905006|144207618|SUPERIORITY||Odds Ratio (OR)|107.83|||<|0.0001|TWO_SIDED|95.0|20.82|558.57|||Regression, Logistic|Confidence intervals, odds ratios, p-values derived from a logistic regression model with fixed effects for treatment, region, prior bio-exposure.||||558.57|20.82|<0.0001
72341773|NCT02905006|144207619|SUPERIORITY||||||=|0.0001|||||||Fisher Exact|||The placebo treatment group contained no PASI100 responders and as such the p-values for the pairwise comparisons are based upon the Fisher's exact test.||||=0.0001
72341774|NCT02905006|144207619|SUPERIORITY||||||=|0.0002|||||||Fisher Exact|||The placebo treatment group contained no PASI100 responders and as such the p-values for the pairwise comparisons are based upon the Fisher's exact test.||||=0.0002
72428602|NCT01374802|144368197|NON_INFERIORITY_OR_EQUIVALENCE|investigation of relative bioavailability (no formal testing)|Geometric Mean Ratio|87.91|STANDARD_DEVIATION|38.3|||TWO_SIDED|90.0|68.609|112.63|||ANOVA||the standard deviation is actually the geometric coefficient of variation|relative bioavailability comparison (Faldaprevir+DRV/r : DRV/r) of Darunavir||112.630|68.609|
72341775|NCT02905006|144207619|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||The placebo treatment group contained no PASI100 responders and as such the p-values for the pairwise comparisons are based upon the Fisher's exact test.||||<0.0001
72341776|NCT02905006|144207619|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||The placebo treatment group contained no PASI100 responders and as such the p-values for the pairwise comparisons are based upon the Fisher's exact test.||||<0.0001
72341777|NCT02905006|144207619|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||The placebo treatment group contained no PASI100 responders and as such the p-values for the pairwise comparisons are based upon the Fisher's exact test.||||<0.0001
72341778|NCT02429791|144207657|NON_INFERIORITY|Non-inferiority was concluded if the lower bound of a two-sided 95% confidence interval for the difference in response rates between the two treatment arms was greater than -10%.|Risk Difference (RD)|-0.6|||||TWO_SIDED|95.0|-4.3|3.0|||||Estimates based on Cochran-Mantel Haenszel stratified analysis adjusting for Baseline stratification factors: Age group (\< or \>=50 years old) and Baseline third agent (PI, NNRTI, INI).|||3.0|-4.3|
72341779|NCT02429791|144207659|OTHER||Risk Difference (RD)|1.0|||||TWO_SIDED|95.0|-1.9|4.0|||||Cochran-Mantel Haenszel stratified analysis adjusting for Baseline stratification factors: Age group (\< or \>=50 years old) and Baseline third agent (PI, NNRTI, INI). No formal non-inferiority margin has been pre-specified for secondary endpoints.|||4.0|-1.9|
72341780|NCT02429791|144207670|OTHER|||||||0.007||||||P-value for interaction between treatment group and baseline third agent (25 hydroxy-vitamin D)|ANCOVA|||||||0.007
72341781|NCT02429791|144207670|SUPERIORITY||Odds Ratio (OR)|0.958||||0.275|TWO_SIDED|95.0|0.888|1.034||P value to assess difference between treatment groups (25 hydroxy-vitamin D - NNRTI)|ANCOVA||Estimates are calculated from an ANCOVA model adjusting for Baseline third agent class, age, sex, BMI category, smoking status and baseline biomarker level.|||1.034|0.888|0.275
72341782|NCT02429791|144207670|SUPERIORITY||Odds Ratio (OR)|0.902||||0.112|TWO_SIDED|95.0|0.793|1.025||P value to assess difference between treatment groups (25 hydroxy-vitamin D - INI)|ANCOVA||Estimates are calculated from an ANCOVA model adjusting for Baseline third agent class, age, sex, BMI category, smoking status and baseline biomarker level.|||1.025|0.793|0.112
72341783|NCT02429791|144207670|SUPERIORITY||Odds Ratio (OR)|0.847||||0.002|TWO_SIDED|95.0|0.763|0.942||P value to assess difference between treatment groups (25 hydroxy-vitamin D - PI)|ANCOVA||Estimates are calculated from an ANCOVA model adjusting for Baseline third agent class, age, sex, BMI category, smoking status and baseline biomarker level.|||0.942|0.763|0.002
72341784|NCT02429791|144207672|OTHER|||||||0.001||||||P-value for interaction between treatment group and baseline third agent (bone-specific alkaline phosphatase)|ANCOVA|||||||0.001
72341785|NCT02429791|144207672|SUPERIORITY||Odds Ratio (OR)|0.724|||<|0.001|TWO_SIDED|95.0|0.679|0.772||P value to assess difference between treatment groups (bone-specific alkaline phosphatase - NNRTI)|ANCOVA||Estimates are calculated from an ANCOVA model adjusting for Baseline third agent class, age, sex, BMI category, smoking status and Baseline biomarker level.|||0.772|0.679|<.001
72341786|NCT02429791|144207672|SUPERIORITY||Odds Ratio (OR)|0.825|||<|0.001|TWO_SIDED|95.0|0.742|0.918||P value to assess difference between treatment groups (bone-specific alkaline phosphatase - INI)|ANCOVA||Estimates are calculated from an ANCOVA model adjusting for Baseline third agent class, age, sex, BMI category, smoking status and Baseline biomarker level.|||0.918|0.742|<.001
72341787|NCT02429791|144207672|SUPERIORITY||Odds Ratio (OR)|0.81|||<|0.001|TWO_SIDED|95.0|0.742|0.884||P value to assess difference between treatment groups (bone-specific alkaline phosphatase - PI)|ANCOVA||Estimates are calculated from an ANCOVA model adjusting for Baseline third agent class, age, sex, BMI category, smoking status and Baseline biomarker level.|||0.884|0.742|<.001
72341788|NCT02429791|144207672|OTHER|||||||0.677||||||P-value for interaction between treatment group and Baseline third agent (procollagen type 1-N-propeptide)|ANCOVA|||||||0.677
72341789|NCT02429791|144207672|SUPERIORITY||Odds Ratio (OR)|0.817|||<|0.001|TWO_SIDED|95.0|0.774|0.863||P value to assess difference between treatment groups (procollagen type 1-N-propeptide)|ANCOVA||Estimates are calculated from an ANCOVA model adjusting for Baseline third agent class, age, sex, BMI category, smoking status and Baseline biomarker level.|||0.863|0.774|<.001
72341790|NCT02429791|144207672|OTHER||||||<|0.001||||||P-value for interaction between treatment group and Baseline third agent (osteocalcin)|ANCOVA|||||||<.001
72341791|NCT02429791|144207672|SUPERIORITY||Odds Ratio (OR)|0.881|||<|0.001|TWO_SIDED|95.0|0.823|0.943||P value to assess difference between treatment groups (osteocalcin - NNRTI)|ANCOVA||Estimates are calculated from an ANCOVA model adjusting for Baseline third agent class, age, sex, BMI category, smoking status and Baseline biomarker level.|||0.943|0.823|<.001
72341792|NCT02429791|144207672|SUPERIORITY||Odds Ratio (OR)|0.829||||0.001|TWO_SIDED|95.0|0.74|0.93||P value to assess difference between treatment groups (osteocalcin - INI)|ANCOVA||Estimates are calculated from an ANCOVA model adjusting for Baseline third agent class, age, sex, BMI category, smoking status and Baseline biomarker level.|||0.930|0.740|0.001
72341793|NCT02429791|144207672|SUPERIORITY||Odds Ratio (OR)|0.691|||<|0.001|TWO_SIDED|95.0|0.628|0.759||P value to assess difference between treatment groups (osteocalcin - PI)|ANCOVA||Estimates are calculated from an ANCOVA model adjusting for Baseline third agent class, age, sex, BMI category, smoking status and Baseline biomarker level.|||0.759|0.628|<.001
72341794|NCT02429791|144207672|OTHER|||||||0.782||||||P-value for interaction between treatment group and baseline third agent (type 1 collagen cross-linked C-telopeptide)|ANCOVA|||||||0.782
72341795|NCT02429791|144207672|SUPERIORITY||Odds Ratio (OR)|0.804|||<|0.001|TWO_SIDED|95.0|0.742|0.872||P value to assess difference between treatment groups (type 1 collagen cross-linked C-telopeptide)|ANCOVA||Estimates are calculated from an ANCOVA model adjusting for Baseline third agent class, age, sex, BMI category, smoking status and Baseline biomarker level.|||0.872|0.742|<.001
72341796|NCT02429791|144207685|OTHER|||||||0.317||||||One-sided p-value from weighted least squares chi-squared statistic. A p-value \<=0.10 was used to indicate statistically significant evidence of heterogeneity in the difference in proportions across levels of each analysis strata.|Chi-squared, Corrected|||||||0.317
72341797|NCT02429791|144207685|OTHER||Risk Difference (RD)|-3.1|||||TWO_SIDED|95.0|-7.7|1.5|||||NNRTI: No formal non-inferiority margin has been pre-specified for secondary endpoints.|||1.5|-7.7|
72341798|NCT02429791|144207685|OTHER||Risk Difference (RD)|2.0|||||TWO_SIDED|95.0|-5.1|9.0|||||INI: No formal non-inferiority margin has been pre-specified for secondary endpoints.|||9.0|-5.1|
72341799|NCT02429791|144207685|OTHER||Risk Difference (RD)|2.8|||||TWO_SIDED|95.0|-5.3|10.8|||||PI: No formal non-inferiority margin has been pre-specified for secondary endpoints.|||10.8|-5.3|
72341800|NCT02429791|144207693|OTHER|||||||0.94||||||P-value for interaction between treatment group and Baseline symptom bother score (Week 4)|ANCOVA|||||||0.940
72341801|NCT02429791|144207693|SUPERIORITY||Mean Difference (Final Values)|-2.924|||<|0.001|TWO_SIDED|95.0|-4.26|-1.588||P value to assess difference between treatment groups (Week 4)|ANCOVA||Estimates are calculated from an ANCOVA model adjusting for age, Baseline third agent, gender, race and Baseline score.|||-1.588|-4.260|<.001
72341802|NCT02429791|144207693|OTHER|||||||0.001||||||P-value for interaction between treatment group and Baseline symptom bother score (Week 24)|ANCOVA|||||||0.001
72341803|NCT02429791|144207693|SUPERIORITY||Mean Difference (Final Values)|-1.192||||0.11|TWO_SIDED|95.0|-2.656|0.271||P value to assess difference between treatment groups (Week 24)|ANCOVA||Estimates are calculated from an ANCOVA model adjusting for age, Baseline third agent, gender, race and Baseline score.|||0.271|-2.656|0.110
72341804|NCT02429791|144207693|OTHER|||||||0.048||||||P-value for interaction between treatment group and Baseline symptom bother score (Week 48)|ANCOVA|||||||0.048
72341805|NCT02429791|144207693|SUPERIORITY||Mean Difference (Final Values)|-1.569||||0.038|TWO_SIDED|95.0|-3.048|-0.09||P value to assess difference between treatment groups (Week 48)|ANCOVA||Estimates are calculated from an ANCOVA model adjusting for age, Baseline third agent, gender, race and Baseline score.|||-0.090|-3.048|0.038
72341806|NCT02429791|144207696|SUPERIORITY|||||||0.002||||||P-value to assess HIVTSQs Total Score difference between treatment groups (Week 4)|Wilcoxon rank sum test|||||||0.002
72341807|NCT02429791|144207696|SUPERIORITY||||||<|0.001||||||P-value to assess HIVTSQs Total Score difference between treatment groups (Week 24)|Wilcoxon rank sum test|||||||<0.001
72341808|NCT02429791|144207696|SUPERIORITY|||||||0.024||||||P-value to assess HIVTSQs Total score difference between treatment groups (Week 48)|Wilcoxon rank sum test|||||||0.024
72341809|NCT02429791|144207696|SUPERIORITY||||||<|0.001||||||P-value to assess HIVTSQs lifestyle/ease sub- score difference between treatment groups (Week 4)|Wilcoxon rank sum test|||||||<0.001
72341810|NCT02429791|144207696|SUPERIORITY||||||<|0.001||||||P-value to assess HIVTSQs lifestyle/ease sub- score difference between treatment groups (Week 24)|Wilcoxon rank sum test|||||||<0.001
72341811|NCT02429791|144207696|SUPERIORITY|||||||0.005||||||P-value to assess HIVTSQs lifestyle/ease sub- score difference between treatment groups (Week 48)|Wilcoxon rank sum test|||||||0.005
72341812|NCT02429791|144207696|SUPERIORITY|||||||0.063||||||P-value to assess HIVTSQs General satisfaction/CS sub- score difference between treatment groups (Week 4)|Wilcoxon rank sum test|||||||0.063
72341813|NCT02429791|144207696|SUPERIORITY|||||||0.002||||||P-value to assess HIVTSQs General satisfaction/CS sub- score difference between treatment groups (Week 24)|Wilcoxon rank sum test|||||||0.002
72341814|NCT02429791|144207696|SUPERIORITY|||||||0.099||||||P-value to assess HIVTSQs General satisfaction/CS sub- score difference between treatment groups (Week 48)|Wilcoxon rank sum test|||||||0.099
72341815|NCT04201093|144207711|SUPERIORITY||LS Mean of Difference|-11.5|STANDARD_ERROR_OF_MEAN|1.16|<|0.0001|TWO_SIDED|95.0|-13.8|-9.2||LS Means, SE, difference from placebo, and CI's are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, treatment by visit interaction and MAO-B inhibitor use with the baseline value as a covariate.|Mixed-effect Model Repeated Measurement|||||-9.2|-13.8|<0.0001
72341816|NCT04201093|144207711|SUPERIORITY||LS Mean of Difference|-12.1|STANDARD_ERROR_OF_MEAN|1.17|<|0.0001|TWO_SIDED|95.0|-14.4|-9.8||LS Means, SE, difference from placebo, and CI's are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, treatment by visit interaction and MAO-B inhibitor use with the baseline value as a covariate.|Mixed-effect Model Repeated Measurement|||||-9.8|-14.4|<0.0001
72341817|NCT04201093|144207712|SUPERIORITY||LS Mean of Difference|-2.5|STANDARD_ERROR_OF_MEAN|0.43|<|0.0001|TWO_SIDED|95.0|-3.3|-1.7||LS Means, SE, difference from placebo, and CI's are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, treatment by visit interaction and MAO-B inhibitor use with the baseline value as a covariate.|Mixed-effect Model Repeated Measurement|||||-1.7|-3.3|<0.0001
72428603|NCT01374802|144368198|NON_INFERIORITY_OR_EQUIVALENCE|investigation of relative bioavailability (no formal testing)|Geometric Mean Ratio|128.41|STANDARD_DEVIATION|15.6|||TWO_SIDED|90.0|115.724|142.489|||ANOVA||the standard deviation is actually the geometric coefficient of variation|relative bioavailability comparison (Faldaprevir+DRV/r : DRV/r) of Darunavir||142.489|115.724|
72428604|NCT02559609|144368209|SUPERIORITY|||||||0.028|||||||Wilcoxon (Mann-Whitney)|||Group A/C (contrast -1) compared to Group B/D (contrast 1) to test Aim 1||||.028
72341818|NCT04201093|144207712|SUPERIORITY||LS Mean of Difference|-2.6|STANDARD_ERROR_OF_MEAN|0.43|<|0.0001|TWO_SIDED|95.0|-3.4|-1.7||LS Means, SE, difference from placebo, and CI's are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, treatment by visit interaction and MAO-B inhibitor use with the baseline value as a covariate.|Mixed-effect Model Repeated Measurement|||||-1.7|-3.4|<0.0001
72341819|NCT04201093|144207713|SUPERIORITY||Odds Ratio (OR)|6.148|||<|0.0001|TWO_SIDED|95.0|3.339|11.321|||Mixed Models Analysis|||||11.321|3.339|<0.0001
72341820|NCT04201093|144207713|SUPERIORITY||Odds Ratio (OR)|5.968|||<|0.0001|TWO_SIDED|95.0|3.22|11.062|||Mixed Models Analysis|||||11.062|3.220|<0.0001
72341821|NCT04201093|144207714|SUPERIORITY||LS Mean of Difference|-11.5|STANDARD_ERROR_OF_MEAN|1.16|<|0.0001|TWO_SIDED|95.0|-13.8|-9.2||LS Means, SE, difference from placebo, and CI's are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, treatment by visit interaction and MAO-B inhibitor use with the baseline value as a covariate.|Mixed-effect Model Repeated Measurement|||Week 26||-9.2|-13.8|<0.0001
72341822|NCT04201093|144207714|SUPERIORITY||LS Mean of Difference|-12.1|STANDARD_ERROR_OF_MEAN|1.17|<|0.0001|TWO_SIDED|95.0|-14.4|-9.8||LS Means, SE, difference from placebo, and CI's are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, treatment by visit interaction and MAO-B inhibitor use with the baseline value as a covariate.|Mixed-effect Model Repeated Measurement|||Week 26||-9.8|-14.4|<0.0001
72341823|NCT04201093|144207715|SUPERIORITY||LS Mean of Difference|-11.7|STANDARD_ERROR_OF_MEAN|1.35|<|0.0001|TWO_SIDED|95.0|-14.4|-9.1||LS Means, SE, difference from placebo, and CI's are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, treatment by visit interaction and MAO-B inhibitor use with the baseline value as a covariate.|Mixed-effect Model Repeated Measurement|||Week 26||-9.1|-14.4|<0.0001
72341824|NCT04201093|144207715|SUPERIORITY||LS Mean of Difference|-12.0|STANDARD_ERROR_OF_MEAN|1.37|<|0.0001|TWO_SIDED|95.0|-14.7|-9.3||LS Means, SE, difference from placebo, and CI's are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, treatment by visit interaction and MAO-B inhibitor use with the baseline value as a covariate.|Mixed-effect Model Repeated Measurement|||Week 26||-9.3|-14.7|<0.0001
72341825|NCT04201093|144207716|SUPERIORITY||LS Mean of Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.38||0.4822|TWO_SIDED|95.0|-1.0|0.5||LS Means, SE, difference from placebo, and CI's are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, treatment by visit interaction and MAO-B inhibitor use with the baseline value as a covariate.|Mixed-effect Model Repeated Measurement|||Part I: Week 26||0.5|-1.0|0.4822
72341826|NCT04201093|144207716|SUPERIORITY||LS Mean of Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.38||0.7742|TWO_SIDED|95.0|-0.9|0.6||LS Means, SE, difference from placebo, and CI's are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, treatment by visit interaction and MAO-B inhibitor use with the baseline value as a covariate.|Mixed-effect Model Repeated Measurement|||Part I: Week 26||0.6|-0.9|0.7742
72428605|NCT02559609|144368210|SUPERIORITY|||||||0.027|||||||Wilcoxon (Mann-Whitney)|||Group A/C (contrast -1) compared to Group B/D (contrast 1)||||.027
72428606|NCT02559609|144368211|SUPERIORITY|||||||0.66|||||||ANOVA|df = 1||Group A/B (contrast -1) was compared to Group C/D (contrast 1) to test Aim 2.||||.66
72428607|NCT02559609|144368212|SUPERIORITY|||||||0.89|||||||Regression, Cox|||Group A/B (contrast -1) compared to Group C/D (contrast 1) to test Aim 2.||||.89
72341827|NCT04201093|144207716|SUPERIORITY||LS Mean of Difference|-2.5|STANDARD_ERROR_OF_MEAN|0.43|<|0.0001|TWO_SIDED|95.0|-3.3|-1.7||LS Means, SE, difference from placebo, and CI's are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, treatment by visit interaction and MAO-B inhibitor use with the baseline value as a covariate.|Mixed-effect Model Repeated Measurement|||Part II: Week 26||-1.7|-3.3|<0.0001
72341828|NCT04201093|144207716|SUPERIORITY||LS Mean of Difference|-2.6|STANDARD_ERROR_OF_MEAN|0.43|<|0.0001|TWO_SIDED|95.0|-3.4|-1.7||LS Means, SE, difference from placebo, and CI's are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, treatment by visit interaction and MAO-B inhibitor use with the baseline value as a covariate.|Mixed-effect Model Repeated Measurement|||Part II: Week 26||-1.7|-3.4|<0.0001
72341829|NCT04201093|144207716|SUPERIORITY||LS Mean of Difference|-9.0|STANDARD_ERROR_OF_MEAN|0.89|<|0.0001|TWO_SIDED|95.0|-10.8|-7.3||LS Means, SE, difference from placebo, and CI's are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, treatment by visit interaction and MAO-B inhibitor use with the baseline value as a covariate.|Mixed-effect Model Repeated Measurement|||Part III: Week 26||-7.3|-10.8|<0.0001
72341830|NCT04201093|144207716|SUPERIORITY||LS Mean of Difference|-9.4|STANDARD_ERROR_OF_MEAN|0.9|<|0.0001|TWO_SIDED|95.0|-11.2|-7.6||LS Means, SE, difference from placebo, and CI's are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, treatment by visit interaction and MAO-B inhibitor use with the baseline value as a covariate.|Mixed-effect Model Repeated Measurement|||Part III: Week 26||-7.6|-11.2|<0.0001
72341831|NCT04201093|144207717|SUPERIORITY||LS Mean of Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.07|<|0.0001|TWO_SIDED|95.0|-0.6|-0.3||LS Means, SE, difference from placebo, and CI's are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, treatment by visit interaction and MAO-B inhibitor use with the baseline value as a covariate.|Mixed-effect Model Repeated Measurement|||Week 26||-0.3|-0.6|<0.0001
72341832|NCT04201093|144207717|SUPERIORITY||LS Mean of Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.07|<|0.0001|TWO_SIDED|95.0|-0.5|-0.2||LS Means, SE, difference from placebo, and CI's are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, treatment by visit interaction and MAO-B inhibitor use with the baseline value as a covariate.|Mixed-effect Model Repeated Measurement|||Week 26||-0.2|-0.5|<0.0001
72341833|NCT04201093|144207718|SUPERIORITY||LS Mean of Difference|-1.1|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-1.4|-0.9||LS Means, SE, difference from placebo, and CI's are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, treatment by visit interaction and MAO-B inhibitor use with the baseline value as a covariate.|Mixed-effect Model Repeated Measurement|||Week 26||-0.9|-1.4|<0.0001
72341834|NCT04201093|144207718|SUPERIORITY||LS Mean of Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-1.2|-0.7||LS Means, SE, difference from placebo, and CI's are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, treatment by visit interaction and MAO-B inhibitor use with the baseline value as a covariate.|Mixed-effect Model Repeated Measurement|||Week 26||-0.7|-1.2|<0.0001
72428608|NCT02559609|144368213|SUPERIORITY|||||||0.58|||||||ANOVA|df = 1||Group A/B (contrast -1) compared to Group C/D (contrast 1) to test Aim 2.||||.58
72428609|NCT02559609|144368214|SUPERIORITY|||||||0.024|||||||Wilcoxon (Mann-Whitney)|||Group A/C (contrast -1) compared to Group B/D (contrast 1) to test Aim 1.||||.024
72428610|NCT00064025|144368215|SUPERIORITY_OR_OTHER|||||||0.701|||||||Fisher Exact|||||||0.701
72341835|NCT04201093|144207719|SUPERIORITY||LS Mean of Difference|-1.2|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-1.4|-0.9||LS Means, SE, difference from placebo, and CI's are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, treatment by visit interaction and MAO-B inhibitor use with the baseline value as a covariate.|Mixed-effect Model Repeated Measurement|||Week 26||-0.9|-1.4|<0.0001
72341836|NCT04201093|144207719|SUPERIORITY||LS Mean of Difference|-1.2|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-1.5|-0.9||LS Means, SE, difference from placebo, and CI's are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, treatment by visit interaction and MAO-B inhibitor use with the baseline value as a covariate.|Mixed-effect Model Repeated Measurement|||Week 26||-0.9|-1.5|<0.0001
72341837|NCT04201093|144207720|SUPERIORITY||LS Mean of Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.32||0.6047|TWO_SIDED|95.0|-0.8|0.5||LS Means, SE, difference from placebo, and CI's are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, treatment by visit interaction and MAO-B inhibitor use with the baseline value as a covariate.|Mixed-effect Model Repeated Measurement|||Week 26||0.5|-0.8|0.6047
72341838|NCT04201093|144207720|SUPERIORITY||LS Mean of Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.33||0.257|TWO_SIDED|95.0|-1.0|0.3||LS Means, SE, difference from placebo, and CI's are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, treatment by visit interaction and MAO-B inhibitor use with the baseline value as a covariate.|Mixed-effect Model Repeated Measurement|||Week 26||0.3|-1.0|0.2570
72341839|NCT04201093|144207721|SUPERIORITY||LS Mean of Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.63||0.8516|TWO_SIDED|95.0|-1.4|1.1||LS Means, SE, difference from placebo, and CI's are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, treatment by visit interaction and MAO-B inhibitor use with the baseline value as a covariate.|Mixed-effect Model Repeated Measurement|||Week 26||1.1|-1.4|0.8516
72341840|NCT04201093|144207721|SUPERIORITY||LS Mean of Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.64||0.6421|TWO_SIDED|95.0|-1.6|1.0||LS Means, SE, difference from placebo, and CI's are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, treatment by visit interaction and MAO-B inhibitor use with the baseline value as a covariate.|Mixed-effect Model Repeated Measurement|||Week 26||1.0|-1.6|0.6421
72341841|NCT01424566|144207796|SUPERIORITY||Mean Difference (Final Values)|-0.02||||0.9173|TWO_SIDED|95.0|-0.42|0.38|||ANCOVA|||||0.38|-0.42|0.9173
72428611|NCT00064025|144368216|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Paired t-test|||||||<.001
72428612|NCT00064025|144368217|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Paired t-test|||||||<.001
72341842|NCT03445559|144207807|SUPERIORITY||Odds Ratio (OR)|0.54||||0.006|TWO_SIDED|95.0|0.3|0.98|||Chi-squared|||||0.98|0.30|0.006
72341843|NCT03445559|144207808|SUPERIORITY||Odds Ratio (OR)|1.36||||0.42|TWO_SIDED|95.0|0.7|2.66|||Chi-squared|||||2.66|0.70|0.42
72341844|NCT03445559|144207809|SUPERIORITY||Median Difference (Final Values)|2.7|||||TWO_SIDED|||||||||||||
72341845|NCT04676867|144207824|SUPERIORITY|||||||0.2|||||||Log Rank|||||||0.2
72341846|NCT04676867|144207825|SUPERIORITY|||||||0.2|||||||ANCOVA|||||||0.2
72341847|NCT04676867|144207826|SUPERIORITY|||||||0.2|||||||ANCOVA|||||||0.2
72341848|NCT04676867|144207827|SUPERIORITY|||||||0.2|||||||Log Rank|||||||0.2
72341849|NCT04676867|144207828|SUPERIORITY|||||||0.2|||||||Log Rank|||||||0.2
72341850|NCT04676867|144207829|SUPERIORITY|||||||0.2|||||||Log Rank|||||||0.2
72428613|NCT03277378|144368218|NON_INFERIORITY|The hypothesis was tested at the 5% significance level.||||||0.0003|||||||Farrington- Manning non-inferioirty test|||"The hypothesis was formally addressed as:~H0: AB - TB ≤ -15% H1: AB - TB \> -15% where AB = permanent system qualification rate of Group 1 (AB) TB = permanent system qualification rate of Group 2 (TB)"||||0.0003
72341851|NCT04676867|144207830|SUPERIORITY|||||||0.2|||||||Log Rank|||||||0.2
72341852|NCT04676867|144207831|SUPERIORITY|||||||0.2|||||||ANCOVA|||||||0.2
72341853|NCT04676867|144207832|SUPERIORITY|||||||0.2|||||||Wilcoxon (Mann-Whitney)|||||||0.2
72341854|NCT04676867|144207833|SUPERIORITY|||||||0.2|||||||Regression, Logistic|||||||0.2
72341855|NCT04676867|144207834|SUPERIORITY|||||||0.2|||||||Regression, Logistic|||||||0.2
72341856|NCT04676867|144207836|SUPERIORITY|||||||0.2|||||||ANOVA|||||||0.2
72341857|NCT04676867|144207837|SUPERIORITY|||||||0.2|||||||Regression, Logistic|||||||0.2
72341858|NCT01300455|144207846|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.66|||||TWO_SIDED|90.0|0.22|5.09|||Difference of the Least Squares Means|||Difference (Suvorexant - Placebo) of Least Squares Means||5.09|0.22|
72341859|NCT01300455|144207849|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.04|||||TWO_SIDED|90.0|-0.49|0.42|||Difference in the Least Squares Means|||Day 1, Difference (Suvorexant - Placebo) of Least Squares Means||0.42|-0.49|
72341860|NCT01300455|144207849|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.06|||||TWO_SIDED|90.0|-0.45|0.33|||Difference of the Least Squares Means|||Day 4, Difference (Suvorexant - Placebo) of Least Squares Means||0.33|-0.45|
72341861|NCT01300455|144207850|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.74|||||TWO_SIDED|90.0|-1.31|2.79|||Difference in the Least Squares Means|||Day 1, SaO2 \<90%, Difference (Suvorexant - Placebo) of Least Squares Means||2.79|-1.31|
72341862|NCT01300455|144207850|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.25|||||TWO_SIDED|90.0|-0.1|0.59|||Difference in the Least Squares Means|||Day 1, SaO2 \<85%, Difference (Suvorexant - Placebo) of Least Squares Means||0.59|-0.10|
72341863|NCT01300455|144207850|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.21|||||TWO_SIDED|90.0|-0.59|1.01|||Difference in the Least Squares Means|||Day 4, SaO2 \<90%, Difference (Suvorexant - Placebo) of Least Squares Means||1.01|-0.59|
72341864|NCT01300455|144207850|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.28|||||TWO_SIDED|90.0|-0.09|0.65|||Difference in the Least Squares Means|||Day 4, SaO2 \<85%, Difference (Suvorexant - Placebo) of Least Squares Means||0.65|-0.09|
72341865|NCT01300455|144207851|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.06|||||TWO_SIDED|90.0|-0.61|0.49|||Difference of Least Squares Means|||Day 1, REM, Difference (Suvorexant - Placebo) of Least Squares Means||0.49|-0.61|
72341866|NCT01300455|144207851|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.05|||||TWO_SIDED|90.0|-0.41|0.5|||Difference of the Least Sqares Means|||Day 1, Non-REM, Difference (Suvorexant - Placebo) of Least Squares Means||0.50|-0.41|
72341867|NCT01300455|144207851|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.51|||||TWO_SIDED|90.0|-1.13|0.1|||Difference of the Least Squares Means|||Day 1, Wake, Difference (Suvorexant - Placebo) of Least Squares Means||0.10|-1.13|
72341868|NCT01300455|144207851|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.13|||||TWO_SIDED|90.0|-0.24|0.5|||Difference of the Least Squares Means|||Day 4, REM, Difference (Suvorexant - Placebo) of Least Squares Means||0.50|-0.24|
72341869|NCT01300455|144207851|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.02|||||TWO_SIDED|90.0|-0.4|0.43|||Difference in the Least Squares Means|||Day 4, Non-REM, Difference (Suvorexant - Placebo) of Least Squares Means||0.43|-0.40|
72341870|NCT01300455|144207851|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.18|||||TWO_SIDED|90.0|-0.61|0.25|||Difference in the Least Squares Means|||Day 4, Wake, Difference (Suvorexant - Placebo) of Least Squares Means||0.25|-0.61|
72341871|NCT01300455|144207852|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.47|||||TWO_SIDED|90.0|-3.2|2.26|||Difference of Least Squares Means|||Difference (Suvorexant - Placebo) of Least Squares Means||2.26|-3.20|
72341872|NCT02228096|144207975|OTHER||||||<|0.0001|||||||Clopper-Pearson|||||||<0.0001
72341873|NCT01364740|144208106|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Sign test|||Patient data from one night with the PMP-300E compared to In-Lab PSG data||||>0.05
72341874|NCT01364740|144208107|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Sign test|||Patient data from one night with the PMP-300E compared to In-Lab PSG data||||>0.05
72341875|NCT01364740|144208108|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Sign test|||Patient data from one night with the PMP-300E compared to In-Lab PSG data||||>0.05
72341876|NCT01364740|144208109|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Sign test|||Patient data from one night with the PMP-300E compared to In-Lab PSG data||||>0.05
72341877|NCT01023672|144208128|SUPERIORITY_OR_OTHER|||||||0.003||95.0|||||Wilcoxon (Mann-Whitney)|||The analysis was done per protocol (n=17)||||0.003
72341878|NCT02166463|144208153|SUPERIORITY|||||||0.0001|||||||Log Rank|Used a one-sided log-rank test between 2 arms||Assuming a 3-year EFS of 82% (5-year EFS of 78.4%, long term EFS of 76%) for standard arm, the study will have approximately 86% power for detecting an 8% improvement in 3-year EFS in the Bv-AVEPC arm (3-year EFS of 90%, 5-year EFS of 88.0%, long term EFS of 86.7%) in log rank test.||||0.0001
72341879|NCT01638546|144208203|OTHER||||||||||||||||||The study will be performed as a double-blind, placebo controlled, randomized Phase II in patients with relapsed sensitive or refractory SCLC. Eligible patients will be randomized 1:1 to one of two treatment arms: ABT-888 and temozolomide as the investigational arm, versus placebo and temozolomide as the control arm. The randomization will be stratified by center and by type or relapse (sensitive vs. refractory). The primary objective is to compare the two treatment regimens with respect to efficacy, expressed as Progression Free Survival (PFS) at 4 months post-randomization. PFS will be calculated as proportion of patients alive and without evidence of disease at 4 months after randomization.|||
72341880|NCT02294734|144208232|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.03||||60.66|TWO_SIDED|95.0|0.85|1.25||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Longitudinal; Lobes; RUL; D12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.25|0.85|60.66
72341881|NCT02294734|144208232|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.19||||95.21|TWO_SIDED|95.0|0.97|1.47||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Longitudinal; Lobes; RUL; D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.47|0.97|95.21
72341882|NCT02294734|144208232|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.06||||74.29|TWO_SIDED|95.0|0.88|1.28||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Longitudinal; Lobes; LUL; D12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.28|0.88|74.29
72341883|NCT02294734|144208232|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.29||||99.48|TWO_SIDED|95.0|1.06|1.58||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Longitudinal; Lobes; LUL; D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.58|1.06|99.48
72341884|NCT02294734|144208232|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.87||||13.98|TWO_SIDED|95.0|0.66|1.13||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Longitudinal; Lobes; RML; D12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.13|0.66|13.98
72341885|NCT02294734|144208232|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.28||||97.92|TWO_SIDED|95.0|1.01|1.62||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Longitudinal; Lobes; RML; D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.62|1.01|97.92
72341886|NCT02294734|144208232|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.14||||80.24|TWO_SIDED|95.0|0.84|1.54||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Longitudinal; Lobes; RLL; D12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.54|0.84|80.24
72341887|NCT02294734|144208232|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.3||||97.79|TWO_SIDED|95.0|1.01|1.66||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Longitudinal; Lobes; RLL; D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.66|1.01|97.79
72341888|NCT02294734|144208232|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.0||||51.27|TWO_SIDED|95.0|0.81|1.25||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Longitudinal; Lobes; LLL; D12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.25|0.81|51.27
72341889|NCT02294734|144208232|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.15||||90.66|TWO_SIDED|95.0|0.93|1.42||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Longitudinal; Lobes; LLL; D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.42|0.93|90.66
72341890|NCT02294734|144208232|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.01||||54.89|TWO_SIDED|95.0|0.9|1.12||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; RUL; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.12|0.90|54.89
72370054|NCT02105961|144250545|SUPERIORITY||Mean difference(Mepolizumab 100-Placebo)|-1.1||||0.926|TWO_SIDED|95.0|-2.3|0.0||Adjusted p-value; Family wise type I error controlled within each endpoint using a Hochberg testing procedure|Mixed Model Repeated Measures Analysis||Analysis performed using mixed model repeated measures with covariates of Baseline CAT score, geographic region, smoking status, treatment and visit, plus interaction terms for visit by Baseline and visit by treatment group.|||0.0|-2.3|0.926
72341891|NCT02294734|144208232|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.1||||94.45|TWO_SIDED|95.0|0.98|1.24||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; RUL; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.24|0.98|94.45
72341892|NCT02294734|144208232|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.09||||94.09|TWO_SIDED|95.0|0.98|1.21||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; RUL; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.21|0.98|94.09
72341893|NCT02294734|144208232|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.02||||62.95|TWO_SIDED|95.0|0.91|1.14||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; LUL; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.14|0.91|62.95
72341894|NCT02294734|144208232|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.12||||96.86|TWO_SIDED|95.0|0.99|1.26||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; LUL; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.26|0.99|96.86
72341895|NCT02294734|144208232|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.09||||94.16|TWO_SIDED|95.0|0.98|1.2||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; LUL; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.20|0.98|94.16
72341896|NCT02294734|144208232|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.0||||48.99|TWO_SIDED|95.0|0.86|1.15||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; RML; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.15|0.86|48.99
72341897|NCT02294734|144208232|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.12||||94.51|TWO_SIDED|95.0|0.98|1.28||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; RML; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.28|0.98|94.51
72341898|NCT02294734|144208232|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.13||||94.59|TWO_SIDED|95.0|0.97|1.31||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; RML; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.31|0.97|94.59
72341899|NCT02294734|144208232|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.03||||61.27|TWO_SIDED|95.0|0.86|1.23||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; RLL; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.23|0.86|61.27
72341900|NCT02294734|144208232|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.15||||96.63|TWO_SIDED|95.0|0.99|1.34||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.No|FRC; Scan Trimmed; Lobes; RLL; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.34|0.99|96.63
72341901|NCT02294734|144208232|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.12||||94.02|TWO_SIDED|95.0|0.97|1.29||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; RLL; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.29|0.97|94.02
72341902|NCT02294734|144208232|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.01||||53.24|TWO_SIDED|95.0|0.87|1.17||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; LLL; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.17|0.87|53.24
72341903|NCT02294734|144208232|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.04||||70.84|TWO_SIDED|95.0|0.91|1.19||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; LLL; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.19|0.91|70.84
72341904|NCT02294734|144208232|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.04||||74.15|TWO_SIDED|95.0|0.92|1.19||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; LLL; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.19|0.92|74.15
72341905|NCT02294734|144208232|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.04||||65.43|TWO_SIDED|95.0|0.87|1.24||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Longitudinal;Region; Upper; D12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.24|0.87|65.43
72341906|NCT02294734|144208232|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.19||||97.15|TWO_SIDED|95.0|0.99|1.42||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Longitudinal; Region; Upper; D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.42|0.99|97.15
72341907|NCT02294734|144208232|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.05||||63.99|TWO_SIDED|95.0|0.81|1.34||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Longitudinal; Region; Lower; D12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.34|0.81|63.99
72341908|NCT02294734|144208232|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.15||||91.99|TWO_SIDED|95.0|0.94|1.41||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Longitudinal; Region; Lower; D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.41|0.94|91.99
72341909|NCT02294734|144208232|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.03||||76.81|TWO_SIDED|95.0|0.94|1.14||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Longitudinal; Region;Central; D12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.14|0.94|76.81
72341910|NCT02294734|144208232|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.02||||67.01|TWO_SIDED|95.0|0.95|1.09||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Longitudinal;Region; Central; D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.09|0.95|67.01
72341911|NCT02294734|144208232|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.04||||63.91|TWO_SIDED|95.0|0.85|1.27||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Longitudinal; Region; Distal; D12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.27|0.85|63.91
72341912|NCT02294734|144208232|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.18||||96.47|TWO_SIDED|95.0|0.99|1.42||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Longitudinal; Region; Distal D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.42|0.99|96.47
72341913|NCT02294734|144208232|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.03||||72.17|TWO_SIDED|95.0|0.93|1.14||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Longitudinal; Region;Total; D12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.14|0.93|72.17
72428614|NCT03277378|144368219|OTHER|||||||0.25|||||||Chi-squared|||"The hypothesis was formally addressed as:~H0: P ≤ 60% H1: P \> 60% where P= percentage of physician prefer anatomic placement over targeted placement.~The analysis population included physicians who have performed both placement procedures. The hypothesis was tested at the 5% significance level."||||0.2500
72341914|NCT02294734|144208232|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.03||||74.38|TWO_SIDED|95.0|0.95|1.11||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Longitudinal; Region; Total; D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.11|0.95|74.38
72341915|NCT02294734|144208232|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.01||||53.85|TWO_SIDED|95.0|0.9|1.12||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Region;Upper; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.12|0.90|53.85
72341916|NCT02294734|144208232|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.1||||95.02|TWO_SIDED|95.0|0.98|1.23||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Region;Upper; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.23|0.98|95.02
72341917|NCT02294734|144208232|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.07||||92.27|TWO_SIDED|95.0|0.97|1.18||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Region;Upper; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.18|0.97|92.27
72341918|NCT02294734|144208232|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.01||||54.65|TWO_SIDED|95.0|0.88|1.16||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Region;Lower; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.16|0.88|54.65
72341919|NCT02294734|144208232|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.08||||87.93|TWO_SIDED|95.0|0.95|1.23||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Region; Lower; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.23|0.95|87.93
72341920|NCT02294734|144208232|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.05||||77.57|TWO_SIDED|95.0|0.92|1.19||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Region;Lower; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.19|0.92|77.57
72341921|NCT02294734|144208232|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.03||||77.07|TWO_SIDED|95.0|0.95|1.11||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC;Scan Trimmed;Region;Central; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.11|0.95|77.07
72341922|NCT02294734|144208232|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.03||||78.42|TWO_SIDED|95.0|0.96|1.1||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC;Scan Trimmed; Region Central; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.10|0.96|78.42
72341923|NCT02294734|144208232|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.0||||44.15|TWO_SIDED|95.0|0.93|1.06||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC;Scan Trimmed;Region Central; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.06|0.93|44.15
72341924|NCT02294734|144208232|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.0||||52.79|TWO_SIDED|95.0|0.89|1.13||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC;Scan Trimmed; Region;Distal; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.13|0.89|52.79
72370055|NCT02105961|144250545|SUPERIORITY||Mean difference(Mepolizumab 100-Placebo)|-1.1||||0.055|TWO_SIDED|95.0|-2.3|0.0||Unadjusted p-value|Mixed Model Repeated Measures Analysis||Analysis performed using mixed model repeated measures with covariates of Baseline CAT score, geographic region, smoking status, treatment and visit, plus interaction terms for visit by Baseline and visit by treatment group.|||0.0|-2.3|0.055
72341925|NCT02294734|144208232|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.1||||94.51|TWO_SIDED|95.0|0.98|1.24||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC;Scan Trimmed;Region; Distal; SCRD28 .The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.24|0.98|94.51
72341926|NCT02294734|144208232|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.08||||93.16|TWO_SIDED|95.0|0.98|1.19||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC;Scan Trimmed;Region;Distal; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.19|0.98|93.16
72341927|NCT02294734|144208232|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.03||||73.7|TWO_SIDED|95.0|0.95|1.11||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC;Scan Trimmed; Region;Total; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.11|0.95|73.70
72341928|NCT02294734|144208232|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.03||||81.04|TWO_SIDED|95.0|0.96|1.1||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC;Scan Trimmed;Region;Total; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.10|0.96|81.04
72341929|NCT02294734|144208232|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.0||||52.58|TWO_SIDED|95.0|0.94|1.07||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed;Region;Total; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.07|0.94|52.58
72341930|NCT02294734|144208232|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.95||||15.85|TWO_SIDED|95.0|0.86|1.05||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Longitudinal; Lobes; RUL; D12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.05|0.86|15.85
72341931|NCT02294734|144208232|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.0||||48.69|TWO_SIDED|95.0|0.9|1.11||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Longitudinal; Lobes; RUL; D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.11|0.90|48.69
72341932|NCT02294734|144208232|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.0||||52.25|TWO_SIDED|95.0|0.9|1.13||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Longitudinal; Lobes; LUL; D12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.13|0.90|52.25
72341933|NCT02294734|144208232|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.03||||66.48|TWO_SIDED|95.0|0.91|1.16||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Longitudinal; Lobes; LUL; D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.16|0.91|66.48
72341934|NCT02294734|144208232|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.88||||9.12|TWO_SIDED|95.0|0.72|1.06||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Longitudinal; Lobes; RML; D12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.06|0.72|9.12
72341935|NCT02294734|144208232|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.92||||16.95|TWO_SIDED|95.0|0.78|1.09||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Longitudinal; Lobes; RML; D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.09|0.78|16.95
72341936|NCT02294734|144208232|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.89||||0.89|TWO_SIDED|95.0|0.75|1.05||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Longitudinal; Lobes; RLL; D12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.05|0.75|0.89
72341937|NCT02294734|144208232|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.0||||50.4|TWO_SIDED|95.0|0.86|1.17||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Longitudinal; Lobes; RLL; D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.17|0.86|50.40
72341938|NCT02294734|144208232|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.89||||7.44|TWO_SIDED|95.0|0.76|1.04||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Longitudinal; Lobes; LLL; D12 .The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.04|0.76|7.44
72341939|NCT02294734|144208232|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.01||||56.35|TWO_SIDED|95.0|0.87|1.18||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Longitudinal; Lobes; LLL; D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.18|0.87|56.35
72341940|NCT02294734|144208232|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.93||||4.03|TWO_SIDED|95.0|0.87|1.01||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; RUL; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.01|0.87|4.03
72341941|NCT02294734|144208232|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.97||||24.79|TWO_SIDED|95.0|0.89|1.06||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; RUL; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.06|0.89|24.79
72341942|NCT02294734|144208232|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.03||||77.08|TWO_SIDED|95.0|0.95|1.12||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; RUL; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.12|0.95|77.08
72341943|NCT02294734|144208232|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.97||||23.07|TWO_SIDED|95.0|0.89|1.05||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; LUL; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.05|0.89|23.07
72341944|NCT02294734|144208232|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.96||||18.58|TWO_SIDED|95.0|0.88|1.05||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; LUL; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.05|0.88|18.58
72341945|NCT02294734|144208232|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.99||||44.94|TWO_SIDED|95.0|0.92|1.08||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; LUL; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.08|0.92|44.94
72341946|NCT02294734|144208232|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.89||||2.21|TWO_SIDED|95.0|0.8|1.0||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; RML; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.00|0.80|2.21
72341947|NCT02294734|144208232|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.92||||6.09|TWO_SIDED|95.0|0.83|1.02||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; RML; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.02|0.83|6.09
72341948|NCT02294734|144208232|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.02||||66.6|TWO_SIDED|95.0|0.92|1.13||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; RML; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.13|0.92|66.60
72341949|NCT02294734|144208232|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.9||||3.23|TWO_SIDED|95.0|0.81|1.01||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; RLL; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.01|0.81|3.23
72341950|NCT02294734|144208232|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.96||||20.83|TWO_SIDED|95.0|0.86|1.07||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; RLL; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.07|0.86|20.83
72341951|NCT02294734|144208232|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.06||||87.6|TWO_SIDED|95.0|0.96|1.16||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; RLL; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.16|0.96|87.60
72341952|NCT02294734|144208232|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.93||||7.9|TWO_SIDED|95.0|0.84|1.03||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; LLL; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.03|0.84|7.90
72341953|NCT02294734|144208232|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.96||||23.39|TWO_SIDED|95.0|0.87|1.07||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; LLL; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.07|0.87|23.39
72341954|NCT02294734|144208232|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.03||||76.16|TWO_SIDED|95.0|0.95|1.12||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; LLL; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.12|0.95|76.16
72341955|NCT02294734|144208232|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.96||||22.54|TWO_SIDED|95.0|0.87|1.06||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Longitudinal;Region; Upper; D12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.06|0.87|22.54
72341956|NCT02294734|144208232|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.01||||58.17|TWO_SIDED|95.0|0.91|1.12||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Longitudinal; Region; Upper; D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.12|0.91|58.17
72341957|NCT02294734|144208232|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.89||||6.22|TWO_SIDED|95.0|0.76|1.03||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Longitudinal; Region; Lower; D12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.03|0.76|6.22
72341958|NCT02294734|144208232|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.01||||55.85|TWO_SIDED|95.0|0.88|1.17||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Longitudinal; Region; Lower; D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.17|0.88|55.85
72341959|NCT02294734|144208232|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.99||||25.44|TWO_SIDED|95.0|0.96|1.02||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Longitudinal; Region;Central; D12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.02|0.96|25.44
72341960|NCT02294734|144208232|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.99||||18.15|TWO_SIDED|95.0|0.96|1.02||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Longitudinal;Region; Cetral; D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.02|0.96|18.15
72341961|NCT02294734|144208232|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.92||||8.12|TWO_SIDED|95.0|0.82|1.04||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Longitudinal; Region; Distal; D12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.04|0.82|8.12
72341962|NCT02294734|144208232|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.01||||57.39|TWO_SIDED|95.0|0.9|1.13||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Longitudinal; Region; Distal D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.13|0.90|57.39
72341963|NCT02294734|144208232|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.97||||10|TWO_SIDED|95.0|0.93|1.02||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Longitudinal; Region;Total; D12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.02|0.93|10.00
72341964|NCT02294734|144208232|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.99||||29.88|TWO_SIDED|95.0|0.95|1.03||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Longitudinal; Region; Total; D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.03|0.95|29.88
72341965|NCT02294734|144208232|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.96||||12.63|TWO_SIDED|95.0|0.89|1.03||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Region;Upper; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.03|0.89|12.63
72341966|NCT02294734|144208232|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.98||||32.29|TWO_SIDED|95.0|0.91|1.06||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Region;Upper; SCRD28 The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.06|0.91|32.29
72341967|NCT02294734|144208232|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.02||||69.92|TWO_SIDED|95.0|0.95|1.1||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Region;Upper; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.10|0.95|69.92
72341968|NCT02294734|144208232|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.93||||6.1|TWO_SIDED|95.0|0.84|1.02||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Region;Lower; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.02|0.84|6.10
72341969|NCT02294734|144208232|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.98||||33.63|TWO_SIDED|95.0|0.89|1.08||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Region; Lower; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.08|0.89|33.63
72341970|NCT02294734|144208232|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.05||||86.07|TWO_SIDED|95.0|0.97|1.13||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Region;Lower; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.13|0.97|86.07
72341971|NCT02294734|144208232|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.0||||41.38|TWO_SIDED|95.0|0.96|1.03||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC;Scan Trimmed;Region;Central; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.03|0.96|41.38
72370056|NCT02105961|144250545|SUPERIORITY||Mean difference(Mepolizumab 300-Placebo)|-0.4||||0.926|TWO_SIDED|95.0|-1.5|0.8||Adjusted p-value; Family wise type I error controlled within each endpoint using a Hochberg testing procedure|Mixed Model Repeated Measures Analysis||Analysis performed using mixed model repeated measures with covariates of Baseline CAT score, geographic region, smoking status, treatment and visit, plus interaction terms for visit by Baseline and visit by treatment group.|||0.8|-1.5|0.926
72341972|NCT02294734|144208232|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.99||||24.88|TWO_SIDED|95.0|0.96|1.02||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC;Scan Trimmed; Region Central; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.02|0.96|24.88
72341973|NCT02294734|144208232|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.99||||29.89|TWO_SIDED|95.0|0.97|1.02||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC;Scan Trimmed;Region Central; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.02|0.97|29.89
72341974|NCT02294734|144208232|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.94||||7.13|TWO_SIDED|95.0|0.87|1.02||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC;Scan Trimmed; Region;Distal; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.02|0.87|7.13
72341975|NCT02294734|144208232|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.98||||32.91|TWO_SIDED|95.0|0.9|1.07||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC;Scan Trimmed;Region; Distal; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.07|0.90|32.91
72341976|NCT02294734|144208232|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.03||||81.15|TWO_SIDED|95.0|0.96|1.11||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC;Scan Trimmed;Region;Distal; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.11|0.96|81.15
72341977|NCT02294734|144208232|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.98||||21.87|TWO_SIDED|95.0|0.95|1.02||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC;Scan Trimmed; Region;Total; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.02|0.95|21.87
72341978|NCT02294734|144208232|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.99||||24.49|TWO_SIDED|95.0|0.95|1.02||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC;Scan Trimmed;Region;Total; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.02|0.95|24.49
72341979|NCT02294734|144208232|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.0||||55.52|TWO_SIDED|95.0|0.97|1.03||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed;Region;Total; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.03|0.97|55.52
72341980|NCT02294734|144208233|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.02||||59.55|TWO_SIDED|95.0|0.84|1.25||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|(FRC; Longitudinal; Lobes; RUL; D12, The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.25|0.84|59.55
72341981|NCT02294734|144208233|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.18||||94.01|TWO_SIDED|95.0|0.96|1.46||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|(FRC; Longitudinal; Lobes; RUL; D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.46|0.96|94.01
72341982|NCT02294734|144208233|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.1||||82.27|TWO_SIDED|95.0|0.9|1.33||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Longitudinal; Lobes; LUL; D12, The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.33|0.90|82.27
72341983|NCT02294734|144208233|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.31||||99.22|TWO_SIDED|95.0|1.06|1.61||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Longitudinal; Lobes; LUL; D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.61|1.06|99.22
72341984|NCT02294734|144208233|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.99||||46.24|TWO_SIDED|95.0|0.75|1.29||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Longitudinal; Lobes; RML; D12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.29|0.75|46.24
72341985|NCT02294734|144208233|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.29||||98.3|TWO_SIDED|95.0|1.02|1.64||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Longitudinal; Lobes; RML; D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.64|1.02|98.30
72341986|NCT02294734|144208233|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.25||||92.6|TWO_SIDED|95.0|0.92|1.7||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Longitudinal; Lobes; RLL; D12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.70|0.92|92.60
72341987|NCT02294734|144208233|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.38||||99.01|TWO_SIDED|95.0|1.05|1.81||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Longitudinal; Lobes; RLL; D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.81|1.05|99.01
72341988|NCT02294734|144208233|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.02||||58.8|TWO_SIDED|95.0|0.82|1.28||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Longitudinal; Lobes; LLL; D12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.28|0.82|58.80
72341989|NCT02294734|144208233|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.13||||86.82|TWO_SIDED|95.0|0.91|1.42||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Longitudinal; Lobes; LLL; D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.42|0.91|86.82
72341990|NCT02294734|144208233|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.02||||67.37|TWO_SIDED|95.0|0.92|1.14||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; RUL; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.14|0.92|67.37
72341991|NCT02294734|144208233|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.14||||98.35|TWO_SIDED|95.0|1.01|1.29||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; RUL; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.29|1.01|98.35
72341992|NCT02294734|144208233|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.1||||96.86|TWO_SIDED|95.0|0.99|1.23||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; RUL; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.23|0.99|96.86
72341993|NCT02294734|144208233|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.07||||86.18|TWO_SIDED|95.0|0.95|1.19||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; LUL; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.19|0.95|86.18
72341994|NCT02294734|144208233|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.16||||98.89|TWO_SIDED|95.0|1.02|1.31||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; LUL; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.31|1.02|98.89
72341995|NCT02294734|144208233|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.08||||91.94|TWO_SIDED|95.0|0.97|1.19||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; LUL; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.19|0.97|91.94
72341996|NCT02294734|144208233|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.01||||55.32|TWO_SIDED|95.0|0.88|1.17||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; RML; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.17|0.88|55.32
72341997|NCT02294734|144208233|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.15||||97.17|TWO_SIDED|95.0|1.0|1.32||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; RML; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.32|1.00|97.17
72341998|NCT02294734|144208233|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.14||||96.57|TWO_SIDED|95.0|0.99|1.32||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; RML; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.32|0.99|96.57
72341999|NCT02294734|144208233|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.07||||79.13|TWO_SIDED|95.0|0.9|1.27||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; RLL; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.27|0.90|79.13
72342000|NCT02294734|144208233|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.22||||99.54|TWO_SIDED|95.0|1.05|1.42||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; RLL; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.42|1.05|99.54
72342001|NCT02294734|144208233|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.14||||97.8|TWO_SIDED|95.0|1.0|1.3||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; RLL; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.30|1.00|97.80
72342002|NCT02294734|144208233|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.04||||71.94|TWO_SIDED|95.0|0.91|1.19||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; LLL; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.19|0.91|71.94
72342003|NCT02294734|144208233|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.08||||85.3|TWO_SIDED|95.0|0.94|1.23||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; LLL; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.23|0.94|85.30
72342004|NCT02294734|144208233|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.06||||82.15|TWO_SIDED|95.0|0.94|1.19||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; LLL; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.19|0.94|82.15
72342005|NCT02294734|144208233|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.06||||72.55|TWO_SIDED|95.0|0.88|1.27||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Longitudinal;Region; Upper; D12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.27|0.88|72.55
72342006|NCT02294734|144208233|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.22||||98.44|TWO_SIDED|95.0|1.02|1.47||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Longitudinal; Region; Upper; D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.47|1.02|98.44
72428615|NCT01370603|144368256|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Equivalence was declared if the 97.5% expanded confidence interval for the mean difference between the fixed-dose combination and co-administration in percent change from baseline was contained within ±4%.|Difference in Least-squares means|-0.2|||||TWO_SIDED|97.5|-1.9|1.4|||ANCOVA|||It was anticipated that 85% of the enrolled participants would be evaluable to achieve 95% power in order to establish equivalence between the Ezetimibe/Atorvastatin Fixed Dose Combination and the co-administration of Ezetimibe and Atorvastatin with respect to percent change from baseline in LDL-C after 6 weeks of treatment using two one-sided tests each at 2.5% α-level, assuming the underlying true treatment difference is ±1.08% and that the standard deviation of the difference is 12.8%.||1.4|-1.9|
72342007|NCT02294734|144208233|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.11||||78.24|TWO_SIDED|95.0|0.86|1.43||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Longitudinal; Region; Lower; D12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.43|0.86|78.24
72342008|NCT02294734|144208233|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.23||||96.8|TWO_SIDED|95.0|0.99|1.52||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Longitudinal; Region; Lower; D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.52|0.99|96.80
72342009|NCT02294734|144208233|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.07||||91.11|TWO_SIDED|95.0|0.97|1.17||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Longitudinal; Region;Central; D12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.17|0.97|91.11
72342010|NCT02294734|144208233|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.05||||89.3|TWO_SIDED|95.0|0.97|1.13||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Longitudinal;Region; Cetral; D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.13|0.97|89.30
72342011|NCT02294734|144208233|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.07||||74.67|TWO_SIDED|95.0|0.87|1.32||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Longitudinal; Region; Distal; D12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.32|0.87|74.67
72342012|NCT02294734|144208233|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.23||||98.25|TWO_SIDED|95.0|1.02|1.48||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Longitudinal; Region; Distal D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.48|1.02|98.25
72342013|NCT02294734|144208233|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.06||||87.8|TWO_SIDED|95.0|0.96|1.18||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Longitudinal; Region;Total; D12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.18|0.96|87.80
72342014|NCT02294734|144208233|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.06||||91.54|TWO_SIDED|95.0|0.97|1.15||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Longitudinal; Region; Total; D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.15|0.97|91.54
72342015|NCT02294734|144208233|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.03||||68.89|TWO_SIDED|95.0|0.92|1.14||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Region;Upper; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.14|0.92|68.89
72342016|NCT02294734|144208233|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.13||||98.19|TWO_SIDED|95.0|1.01|1.27||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Region;Upper; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.27|1.01|98.19
72342017|NCT02294734|144208233|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.08||||94.07|TWO_SIDED|95.0|0.98|1.19||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Region;Upper; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.19|0.98|94.07
72342018|NCT02294734|144208233|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.05||||75.74|TWO_SIDED|95.0|0.92|1.19||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Region;Lower; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.19|0.92|75.74
72428616|NCT01370603|144368257|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least-squares means|-0.1|||||TWO_SIDED|97.5|-1.4|1.2|||ANCOVA|||||1.2|-1.4|
72342019|NCT02294734|144208233|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.12||||95.83|TWO_SIDED|95.0|0.99|1.28||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Region; Lower; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.28|0.99|95.83
72342020|NCT02294734|144208233|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.05||||79.8|TWO_SIDED|95.0|0.94|1.17||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Region;Lower; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.17|0.94|79.80
72342021|NCT02294734|144208233|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.06||||95.29|TWO_SIDED|95.0|0.99|1.13||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC;Scan Trimmed;Region;Central; SCRD12 .The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.13|0.99|95.29
72342022|NCT02294734|144208233|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.06||||96.27|TWO_SIDED|95.0|0.99|1.13||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC;Scan Trimmed; Region Central; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.13|0.99|96.27
72342023|NCT02294734|144208233|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.0||||47.62|TWO_SIDED|95.0|0.94|1.06||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC;Scan Trimmed;Region Central; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.06|0.94|47.62
72342024|NCT02294734|144208233|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.03||||71.55|TWO_SIDED|95.0|0.92|1.15||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC;Scan Trimmed; Region;Distal; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.15|0.92|71.55
72342025|NCT02294734|144208233|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.13||||98.29|TWO_SIDED|95.0|1.01|1.28||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC;Scan Trimmed;Region; Distal; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.28|1.01|98.29
72342026|NCT02294734|144208233|SUPERIORITY_OR_OTHER_LEGACY||Bayesian repeated measures model|1.08||||95.09|TWO_SIDED|95.0|0.99|1.19||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC;Scan Trimmed;Region;Distal; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.19|0.99|95.09
72342027|NCT02294734|144208233|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.05||||93.68|TWO_SIDED|95.0|0.98|1.13||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC;Scan Trimmed; Region;Total; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.13|0.98|93.68
72342028|NCT02294734|144208233|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.06||||96.58|TWO_SIDED|95.0|1.0|1.14||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC;Scan Trimmed;Region;Total; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.14|1.00|96.58
72342029|NCT02294734|144208233|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.0||||56.99|TWO_SIDED|95.0|0.95|1.06||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed;Region;Total; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.06|0.95|56.99
72342030|NCT02294734|144208233|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.94||||13.08|TWO_SIDED|95.0|0.85|1.04||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Longitudinal; Lobes; RUL; D12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.04|0.85|13.08
72428617|NCT01370603|144368258|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least-squares means|-0.3|||||TWO_SIDED|97.5|-1.8|1.2|||ANCOVA|||||1.2|-1.8|
72342031|NCT02294734|144208233|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.0||||52.99|TWO_SIDED|95.0|0.89|1.13||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Longitudinal; Lobes; RUL; D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.13|0.89|52.99
72342032|NCT02294734|144208233|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.02||||60.75|TWO_SIDED|95.0|0.9|1.14||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Longitudinal; Lobes; LUL; D12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.14|0.90|60.75
72342033|NCT02294734|144208233|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.05||||75.23|TWO_SIDED|95.0|0.92|1.2||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Longitudinal; Lobes; LUL; D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.20|0.92|75.23
72342034|NCT02294734|144208233|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.95||||28.14|TWO_SIDED|95.0|0.78|1.14||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Longitudinal; Lobes; RML; D12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.14|0.78|28.14
72342035|NCT02294734|144208233|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.98||||38.43|TWO_SIDED|95.0|0.84|1.14||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Longitudinal; Lobes; RML; D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.14|0.84|38.43
72342036|NCT02294734|144208233|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.95||||25.21|TWO_SIDED|95.0|0.8|1.12||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Longitudinal; Lobes; RLL; D12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.12|0.80|25.21
72342037|NCT02294734|144208233|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.08||||81.73|TWO_SIDED|95.0|0.91|1.27||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Longitudinal; Lobes; RLL; D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.27|0.91|81.73
72342038|NCT02294734|144208233|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.9||||9.87|TWO_SIDED|95.0|0.76|1.06||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Longitudinal; Lobes; LLL; D12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.06|0.76|9.87
72342039|NCT02294734|144208233|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.03||||63.15|TWO_SIDED|95.0|0.87|1.21||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Longitudinal; Lobes; LLL; D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.21|0.87|63.15
72342040|NCT02294734|144208233|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.93||||4.03|TWO_SIDED|95.0|0.86|1.01||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; RUL; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.01|0.86|4.03
72342041|NCT02294734|144208233|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.97||||30.03|TWO_SIDED|95.0|0.89|1.07||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; RUL; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.07|0.89|30.03
72342042|NCT02294734|144208233|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.04||||80.34|TWO_SIDED|95.0|0.95|1.13||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; RUL; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.13|0.95|80.34
72428618|NCT01370603|144368259|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least-squares Means|-0.2|||||TWO_SIDED|97.5|-1.7|1.4|||ANCOVA|||||1.4|-1.7|
72428619|NCT01370603|144368260|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least-squares means|-0.5|||||TWO_SIDED|97.5|-1.9|1.0|||ANCOVA|||||1.0|-1.9|
72342043|NCT02294734|144208233|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.97||||25.65|TWO_SIDED|95.0|0.89|1.06||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; LUL; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.06|0.89|25.65
72342044|NCT02294734|144208233|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.97||||24.36|TWO_SIDED|95.0|0.88|1.06||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; LUL; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.06|0.88|24.36
72342045|NCT02294734|144208233|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.0||||48.45|TWO_SIDED|95.0|0.91|1.09||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; LUL; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.09|0.91|48.45
72342046|NCT02294734|144208233|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.89||||1.95|TWO_SIDED|95.0|0.81|0.99||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; RML; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||0.99|0.81|1.95
72342047|NCT02294734|144208233|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.94||||14.15|TWO_SIDED|95.0|0.85|1.05||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; RML; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.05|0.85|14.15
72342048|NCT02294734|144208233|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.05||||80.61|TWO_SIDED|95.0|0.95|1.16||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; RML; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.16|0.95|80.61
72342049|NCT02294734|144208233|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.91||||3.3|TWO_SIDED|95.0|0.81|1.01||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; RLL; SCRD12.The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.01|0.81|3.30
72342050|NCT02294734|144208233|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.99||||42.22|TWO_SIDED|95.0|0.88|1.11||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; RLL; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.11|0.88|42.22
72342051|NCT02294734|144208233|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.09||||95.24|TWO_SIDED|95.0|0.99|1.2||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; RLL; D12D28The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.20|0.99|95.24
72342052|NCT02294734|144208233|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.92||||6.38|TWO_SIDED|95.0|0.83|1.03||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; LLL; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.03|0.83|6.38
72342053|NCT02294734|144208233|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.97||||28.82|TWO_SIDED|95.0|0.86|1.09||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; LLL; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.09|0.86|28.82
72428620|NCT01370603|144368261|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least-squares Means|0.0|||||TWO_SIDED|97.5|-4.9|4.9|||constrained Longitudinal Data Analysis|||||4.9|-4.9|
72428621|NCT00518713|144368262|SUPERIORITY_OR_OTHER|||||||0.012||95.0|||||ANCOVA|||Analysis of covariance (ANCOVA) with the percent reduction in drop seizures as the dependent variable and treatment, pooled center, and baseline drop seizure rate as the independent variables. A step-down procedure used, starting with the high dose versus placebo.||||0.0120
72428622|NCT00518713|144368262|SUPERIORITY_OR_OTHER|||||||0.0015||95.0|||||ANCOVA|||ANCOVA with the percent reduction in drop seizures as the dependent variable and treatment, pooled center, and baseline drop seizure rate as the independent variables. A step-down procedure used, starting with the high dose versus placebo.||||0.0015
72342054|NCT02294734|144208233|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.05||||87.39|TWO_SIDED|95.0|0.97|1.14||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; LLL; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.14|0.97|87.39
72342055|NCT02294734|144208233|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.96||||23.27|TWO_SIDED|95.0|0.87|1.07||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Longitudinal; Region; Upper; D12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.07|0.87|23.27
72342056|NCT02294734|144208233|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.01||||57.82|TWO_SIDED|95.0|0.9|1.13||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model.|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Longitudinal; Region; Upper; D28.The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.13|0.90|57.82
72342057|NCT02294734|144208233|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.9||||9.67|TWO_SIDED|95.0|0.77|1.06||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model.|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Longitudinal; Region; Lower; D12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.06|0.77|9.67
72342058|NCT02294734|144208233|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.04||||70.73|TWO_SIDED|95.0|0.89|1.22||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model.|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Longitudinal; Region; Lower; D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.22|0.89|70.73
72342059|NCT02294734|144208233|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.99||||25.61|TWO_SIDED|95.0|0.95|1.02||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model.|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Longitudinal; Region; Central; D12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.02|0.95|25.61
72342060|NCT02294734|144208233|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.0||||44.1|TWO_SIDED|95.0|0.96|1.03||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model.|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Longitudinal; Region; Cetral; D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.03|0.96|44.10
72342061|NCT02294734|144208233|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.92||||10.14|TWO_SIDED|95.0|0.82|1.04||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model.|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Longitudinal; Region; Distal; D12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.04|0.82|10.14
72342062|NCT02294734|144208233|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.02||||62.87|TWO_SIDED|95.0|0.9|1.16||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model.|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Longitudinal; Region; Distal D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.16|0.90|62.87
72342063|NCT02294734|144208233|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.97||||11.82|TWO_SIDED|95.0|0.93|1.02||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model.|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Longitudinal; Region; Total; D12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.02|0.93|11.82
72342064|NCT02294734|144208233|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.0||||51.44|TWO_SIDED|95.0|0.95|1.05||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model.|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Longitudinal; Region; Total; D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.05|0.95|51.44
72342065|NCT02294734|144208233|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.95||||9.54|TWO_SIDED|95.0|0.88|1.03||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Region; Upper; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.03|0.88|9.54
72342066|NCT02294734|144208233|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.98||||30.03|TWO_SIDED|95.0|0.89|1.07||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Region; Upper; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.07|0.89|30.03
72342067|NCT02294734|144208233|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.02||||73.03|TWO_SIDED|95.0|0.95|1.11||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model.|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Region; Upper; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.11|0.95|73.03
72342068|NCT02294734|144208233|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.92||||4.64|TWO_SIDED|95.0|0.83|1.01||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model.|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Region; Lower; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.01|0.83|4.64
72342069|NCT02294734|144208233|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.99||||42.13|TWO_SIDED|95.0|0.89|1.1||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Region; Lower; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.10|0.89|42.13
72342070|NCT02294734|144208233|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.07||||93.33|TWO_SIDED|95.0|0.98|1.16||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Region; Lower; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.16|0.98|93.33
72342071|NCT02294734|144208233|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.99||||27.33|TWO_SIDED|95.0|0.95|1.02||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Region; Central; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.02|0.95|27.33
72342072|NCT02294734|144208233|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.99||||34.15|TWO_SIDED|95.0|0.96|1.03||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Region Central; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.03|0.96|34.15
72342073|NCT02294734|144208233|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.0||||58.42|TWO_SIDED|95.0|0.98|1.03||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Region Central; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.03|0.98|58.42
72342074|NCT02294734|144208233|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.94||||5.93|TWO_SIDED|95.0|0.86|1.02||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Region; Distal; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.02|0.86|5.93
72342075|NCT02294734|144208233|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.98||||35.88|TWO_SIDED|95.0|0.89|1.08||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Region; Distal; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.08|0.89|35.88
72342076|NCT02294734|144208233|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.04||||86.41|TWO_SIDED|95.0|0.97|1.13||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Region; Distal; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.13|0.97|86.41
72342077|NCT02294734|144208233|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.98||||13.52|TWO_SIDED|95.0|0.94|1.02||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Region; Total; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.02|0.94|13.52
72342078|NCT02294734|144208233|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.99||||32.84|TWO_SIDED|95.0|0.95|1.03||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Region; Total; SCRD28 .The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.03|0.95|32.84
72342079|NCT02294734|144208233|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.01||||78.09|TWO_SIDED|95.0|0.98|1.04||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Region; Total; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.04|0.98|78.09
72342080|NCT02294734|144208234|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.95||||60.07|TWO_SIDED|95.0|0.66|1.39||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; RUL; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.39|0.66|60.07
72342081|NCT02294734|144208234|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.99||||51.75|TWO_SIDED|95.0|0.65|1.53||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; RUL; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.53|0.65|51.75
72342082|NCT02294734|144208234|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.92||||65.66|TWO_SIDED|95.0|0.6|1.4||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; RUL; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.40|0.60|65.66
72342083|NCT02294734|144208234|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.85||||81.67|TWO_SIDED|95.0|0.59|1.21||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; LUL; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.21|0.59|81.67
72342084|NCT02294734|144208234|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.77||||89.98|TWO_SIDED|95.0|0.51|1.15||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; LUL; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.15|0.51|89.98
72342085|NCT02294734|144208234|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.03||||43.88|TWO_SIDED|95.0|0.7|1.51||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; LUL; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.51|0.70|43.88
72342086|NCT02294734|144208234|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.1||||36.1|TWO_SIDED|95.0|0.64|1.91||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; RML; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.91|0.64|36.10
72342087|NCT02294734|144208234|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.7||||95.74|TWO_SIDED|95.0|0.47|1.05||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; RML; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.05|0.47|95.74
72342088|NCT02294734|144208234|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.0||||50.74|TWO_SIDED|95.0|0.67|1.48||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; RML; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.48|0.67|50.74
72342089|NCT02294734|144208234|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.85||||72.81|TWO_SIDED|95.0|0.51|1.44||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; RLL; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.44|0.51|72.81
72342090|NCT02294734|144208234|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.73||||94.41|TWO_SIDED|95.0|0.5|1.08||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; RLL; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.08|0.50|94.41
72342091|NCT02294734|144208234|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.83||||81.07|TWO_SIDED|95.0|0.55|1.25||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; RLL; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.25|0.55|81.07
72342092|NCT02294734|144208234|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.87||||69.29|TWO_SIDED|95.0|0.5|1.51||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; LLL; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.51|0.50|69.29
72342093|NCT02294734|144208234|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.86||||73.67|TWO_SIDED|95.0|0.54|1.37||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; LLL; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.37|0.54|73.67
72342094|NCT02294734|144208234|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.87||||75.82|TWO_SIDED|95.0|0.59|1.29||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; LLL; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.29|0.59|75.82
72342095|NCT02294734|144208234|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.98||||54.22|TWO_SIDED|95.0|0.69|1.39||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Region; Upper; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.39|0.69|54.22
72342096|NCT02294734|144208234|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.92||||66.46|TWO_SIDED|95.0|0.63|1.35||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Region; Upper; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.35|0.63|66.46
72342097|NCT02294734|144208234|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.16||||21.45|TWO_SIDED|95.0|0.79|1.71||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Region; Upper; D12D28 . The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.71|0.79|21.45
72342098|NCT02294734|144208234|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.86||||69.91|TWO_SIDED|95.0|0.5|1.5||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Region; Lower; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.50|0.50|69.91
72342099|NCT02294734|144208234|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.86||||75.29|TWO_SIDED|95.0|0.57|1.31||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Region; Lower; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.31|0.57|75.29
72342100|NCT02294734|144208234|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.03||||44.05|TWO_SIDED|95.0|0.68|1.58||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Region; Lower; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.58|0.68|44.05
72370057|NCT02105961|144250545|SUPERIORITY||Mean difference(Mepolizumab 300-Placebo)|-0.4||||0.547|TWO_SIDED|95.0|-1.5|0.8||Unadjusted p-value|Mixed Model Repeated Measures Analysis||Analysis performed using mixed model repeated measures with covariates of Baseline CAT score, geographic region, smoking status, treatment and visit, plus interaction terms for visit by Baseline and visit by treatment group.|||0.8|-1.5|0.547
72428623|NCT00518713|144368262|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||ANCOVA with the percent reduction in drop seizures as the dependent variable and treatment, pooled center, and baseline drop seizure rate as the independent variables. A step-down procedure used, starting with the high dose versus placebo.||||<0.0001
72342101|NCT02294734|144208234|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.82||||94.93|TWO_SIDED|95.0|0.65|1.04||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC;Scan Trimmed; Region; Central; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.04|0.65|94.93
72342102|NCT02294734|144208234|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.77||||97.11|TWO_SIDED|95.0|0.59|1.01||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Region Central; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.01|0.59|97.11
72342103|NCT02294734|144208234|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.89||||85.41|TWO_SIDED|95.0|0.7|1.11||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Region Central; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.11|0.70|85.41
72342104|NCT02294734|144208234|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.97||||54.73|TWO_SIDED|95.0|0.62|1.53||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Region; Distal; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.53|0.62|54.73
72342105|NCT02294734|144208234|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.89||||72.31|TWO_SIDED|95.0|0.61|1.3||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Region; Distal; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.30|0.61|72.31
72342106|NCT02294734|144208234|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.21||||15.05|TWO_SIDED|95.0|0.84|1.75||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Region; Distal; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.75|0.84|15.05
72342107|NCT02294734|144208234|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.88||||84.87|TWO_SIDED|95.0|0.68|1.13||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Region; Total; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.13|0.68|84.87
72342108|NCT02294734|144208234|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.82||||92.24|TWO_SIDED|95.0|0.63|1.08||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Region; Total; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.08|0.63|92.24
72342109|NCT02294734|144208234|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.96||||63.42|TWO_SIDED|95.0|0.75|1.22||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Region; Total; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.22|0.75|63.42
72342110|NCT02294734|144208234|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.17||||9.05|TWO_SIDED|95.0|0.93|1.46||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; RUL; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.46|0.93|9.05
72342111|NCT02294734|144208234|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.95||||66.4|TWO_SIDED|95.0|0.74|1.22||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; RUL; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.22|0.74|66.40
72428624|NCT00518713|144368263|SUPERIORITY_OR_OTHER|||||||0.0027||95.0|||||ANCOVA|||ANCOVA with the percent reduction in drop seizures as the dependent variable and treatment, pooled center, and baseline drop seizure rate as the independent variables. A step-down procedure used, starting with the high dose versus placebo.||||0.0027
72428625|NCT00518713|144368263|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||ANCOVA with the percent reduction in drop seizures as the dependent variable and treatment, pooled center, and baseline drop seizure rate as the independent variables. A step-down procedure used, starting with the high dose versus placebo.||||<0.0001
72342112|NCT02294734|144208234|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.78||||97.39|TWO_SIDED|95.0|0.6|1.0||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; RUL; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.00|0.60|97.39
72342113|NCT02294734|144208234|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.13||||16.02|TWO_SIDED|95.0|0.89|1.42||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; LUL; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.42|0.89|16.02
72342114|NCT02294734|144208234|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.9||||75.69|TWO_SIDED|95.0|0.68|1.21||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; LUL; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.21|0.68|75.69
72342115|NCT02294734|144208234|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.86||||90.22|TWO_SIDED|95.0|0.69|1.08||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; LUL; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.08|0.69|90.22
72342116|NCT02294734|144208234|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.21||||9.64|TWO_SIDED|95.0|0.91|1.62||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; RML; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.62|0.91|9.64
72342117|NCT02294734|144208234|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.15||||20.44|TWO_SIDED|95.0|0.82|1.61||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; RML; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.61|0.82|20.44
72342118|NCT02294734|144208234|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.98||||55.06|TWO_SIDED|95.0|0.73|1.31||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; RML; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.31|0.73|55.06
72342119|NCT02294734|144208234|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.36||||5.29|TWO_SIDED|95.0|0.94|1.97||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; RLL; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.97|0.94|5.29
72342120|NCT02294734|144208234|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.11||||28.82|TWO_SIDED|95.0|0.77|1.6||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; RLL; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.60|0.77|28.82
72342121|NCT02294734|144208234|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.81||||93|TWO_SIDED|95.0|0.61|1.07||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; RLL; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.07|0.61|93.00
72342122|NCT02294734|144208234|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.42||||1.64|TWO_SIDED|95.0|1.03|1.95||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; LLL; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.95|1.03|1.64
72342123|NCT02294734|144208234|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.0||||50.71|TWO_SIDED|95.0|0.72|1.38||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; LLL; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.38|0.72|50.71
72342124|NCT02294734|144208234|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.68||||99.52|TWO_SIDED|95.0|0.51|0.91||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; LLL; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||0.91|0.51|99.52
72342125|NCT02294734|144208234|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.22||||3.1|TWO_SIDED|95.0|0.99|1.51||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Region; Upper; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.51|0.99|3.10
72342126|NCT02294734|144208234|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.92||||75.39|TWO_SIDED|95.0|0.71|1.18||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Region; Upper; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.18|0.71|75.39
72342127|NCT02294734|144208234|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.85||||93.29|TWO_SIDED|95.0|0.68|1.05||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Region; Upper; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.05|0.68|93.29
72342128|NCT02294734|144208234|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.33||||3.79|TWO_SIDED|95.0|0.97|1.82||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Region;Lower; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.82|0.97|3.79
72342129|NCT02294734|144208234|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.06||||36.75|TWO_SIDED|95.0|0.76|1.48||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Region; Lower; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.48|0.76|36.75
72342130|NCT02294734|144208234|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.72||||99.32|TWO_SIDED|95.0|0.56|0.93||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Region;Lower; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||0.93|0.56|99.32
72342131|NCT02294734|144208234|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.06||||18.91|TWO_SIDED|95.0|0.93|1.2||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC;Scan Trimmed;Region;Central; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.20|0.93|18.91
72342132|NCT02294734|144208234|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.0||||47.35|TWO_SIDED|95.0|0.87|1.15||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC;Scan Trimmed; Region Central; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.15|0.87|47.35
72342133|NCT02294734|144208234|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.96||||78|TWO_SIDED|95.0|0.86|1.07||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC;Scan Trimmed;Region Central; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.07|0.86|78.00
72370058|NCT04154189|144250547|SUPERIORITY||Hazard Ratio (HR)|0.54||||0.0396|TWO_SIDED|95.0|0.27|1.08||One-sided P value|Log Rank||Hazard ratio was based on Cox Proportional Hazard Model including treatment group as a factor and stratified by Age (less than \[\<\]18 years, more than or equal to \[\>=\]18 years) in interactive response technology (IRT). Efron method was used for ties.|||1.08|0.27|0.0396
72370059|NCT04154189|144250548|OTHER|Difference in PFS rates, and 2-sided 95% confidence intervals (CIs): CI and p-value constructed using the difference of the 2 Kaplan-Meier PFS rates (4 months) and the 2 corresponding Greenwood standard errors.|Difference in Percentage|10.2||||0.1683|TWO_SIDED|95.0|-10.6|31.1||One-sided P value|Kaplan-Meier Method|||||31.1|-10.6|0.1683
72370060|NCT04154189|144250550|OTHER||Hazard Ratio (HR)|0.93||||0.3924|TWO_SIDED|95.0|0.53|1.62||Nominal p-value from stratified log-rank test adjusted for the randomization stratification factor, that is, age.|Stratified Log-rank One-sided Test||Hazard ratio was based on a Cox Proportional Hazard Model including treatment group as a factor and stratified by Age (\<18 years, \>=18 years) in IRT. Efron method was used for ties.|||1.62|0.53|0.3924
72342134|NCT02294734|144208234|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.29||||2.65|TWO_SIDED|95.0|1.0|1.67||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC;Scan Trimmed; Region;Distal; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.67|1.00|2.65
72342135|NCT02294734|144208234|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.97||||58.48|TWO_SIDED|95.0|0.73|1.29||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC;Scan Trimmed;Region; Distal; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.29|0.73|58.48
72342136|NCT02294734|144208234|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.75||||99.64|TWO_SIDED|95.0|0.61|0.92||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.No|TLC;Scan Trimmed;Region;Distal; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||0.92|0.61|99.64
72342137|NCT02294734|144208234|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.19||||1.9|TWO_SIDED|95.0|1.01|1.4||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC;Scan Trimmed; Region;Total; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.40|1.01|1.90
72342138|NCT02294734|144208234|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.97||||63.03|TWO_SIDED|95.0|0.81|1.16||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC;Scan Trimmed;Region;Total; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.16|0.81|63.03
72342139|NCT02294734|144208234|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.83||||99.19|TWO_SIDED|95.0|0.72|0.97||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed;Region;Total; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||0.97|0.72|99.19
72342140|NCT02294734|144208235|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.92||||67.19|TWO_SIDED|95.0|0.64|1.33||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures random effect|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; RUL; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.33|0.64|67.19
72342141|NCT02294734|144208235|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.03||||44.8|TWO_SIDED|95.0|0.66|1.61||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures random effect|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; RUL; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.61|0.66|44.80
72342142|NCT02294734|144208235|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.95||||59.9|TWO_SIDED|95.0|0.61|1.46||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures random effect|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; RUL; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.46|0.61|59.90
72342143|NCT02294734|144208235|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.91||||70.12|TWO_SIDED|95.0|0.63|1.31||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures random effect|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; LUL; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.31|0.63|70.12
72342144|NCT02294734|144208235|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.82||||83.98|TWO_SIDED|95.0|0.54|1.22||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures random effect|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; LUL; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.22|0.54|83.98
72342145|NCT02294734|144208235|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.08||||34.93|TWO_SIDED|95.0|0.73|1.57||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures random effect|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; LUL; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.57|0.73|34.93
72342146|NCT02294734|144208235|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.14||||32.45|TWO_SIDED|95.0|0.65|1.96||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures random effect|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; RML; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.96|0.65|32.45
72342147|NCT02294734|144208235|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.7||||95.35|TWO_SIDED|95.0|0.46|1.06||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures random effect|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; RML; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.06|0.46|95.35
72342148|NCT02294734|144208235|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.0||||50.1|TWO_SIDED|95.0|0.66|1.54||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures random effect|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; RML; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.54|0.66|50.10
72342149|NCT02294734|144208235|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.94||||59.37|TWO_SIDED|95.0|0.55|1.6||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures random effect|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; RLL; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.60|0.55|59.37
72342150|NCT02294734|144208235|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.8||||87.99|TWO_SIDED|95.0|0.55|1.17||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures random effect|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; RLL; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.17|0.55|87.99
72342151|NCT02294734|144208235|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.89||||70.87|TWO_SIDED|95.0|0.59|1.36||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures random effect|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; RLL; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.36|0.59|70.87
72342152|NCT02294734|144208235|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.91||||63.71|TWO_SIDED|95.0|0.51|1.6||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures random effect|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; LLL; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.60|0.51|63.71
72342153|NCT02294734|144208235|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.91||||65.99|TWO_SIDED|95.0|0.57|1.44||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures random effect|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; LLL; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.44|0.57|65.99
72342154|NCT02294734|144208235|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.89||||71.95|TWO_SIDED|95.0|0.6|1.32||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures random effect|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; LLL; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.32|0.60|71.95
72342155|NCT02294734|144208235|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.01||||48.28|TWO_SIDED|95.0|0.71|1.43||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures random effect|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Region;Upper; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.43|0.71|48.28
72342156|NCT02294734|144208235|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.95||||61.06|TWO_SIDED|95.0|0.65|1.39||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures random effect|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Region;Upper; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.39|0.65|61.06
72342157|NCT02294734|144208235|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.19||||18.05|TWO_SIDED|95.0|0.82|1.74||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures random effect|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Region;Upper; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.74|0.82|18.05
72342158|NCT02294734|144208235|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.92||||61.12|TWO_SIDED|95.0|0.53|1.61||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures random effect|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Region;Lower; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.61|0.53|61.12
72342159|NCT02294734|144208235|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.92||||64.4|TWO_SIDED|95.0|0.61|1.41||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures random effect|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Region; Lower; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.41|0.61|64.40
72342160|NCT02294734|144208235|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.07||||38.12|TWO_SIDED|95.0|0.69|1.66||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures random effect|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Region;Lower; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.66|0.69|38.12
72342161|NCT02294734|144208235|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.85||||91|TWO_SIDED|95.0|0.67|1.08||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures random effect|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC;Scan Trimmed;Region;Central; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.08|0.67|91.00
72342162|NCT02294734|144208235|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.81||||94.52|TWO_SIDED|95.0|0.62|1.05||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures random effect|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC;Scan Trimmed; Region Central; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.05|0.62|94.52
72342163|NCT02294734|144208235|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.9||||82.11|TWO_SIDED|95.0|0.72|1.13||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures random effect|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC;Scan Trimmed;Region Central; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.13|0.72|82.11
72342164|NCT02294734|144208235|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.01||||48.1|TWO_SIDED|95.0|0.64|1.6||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures random effect|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC;Scan Trimmed; Region;Distal; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.60|0.64|48.10
72342165|NCT02294734|144208235|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.93||||65.66|TWO_SIDED|95.0|0.64|1.36||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures random effect|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC;Scan Trimmed;Region; Distal; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.36|0.64|65.66
72342166|NCT02294734|144208235|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.25||||11.46|TWO_SIDED|95.0|0.87|1.8||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures random effect|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC;Scan Trimmed;Region;Distal; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.80|0.87|11.46
72342167|NCT02294734|144208235|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.91||||77.2|TWO_SIDED|95.0|0.7|1.17||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures random effect|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC;Scan Trimmed; Region;Total; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.17|0.70|77.20
72342168|NCT02294734|144208235|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.86||||87.35|TWO_SIDED|95.0|0.66|1.11||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures random effect|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC;Scan Trimmed;Region;Total; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.11|0.66|87.35
72342169|NCT02294734|144208235|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.98||||56.53|TWO_SIDED|95.0|0.77|1.25||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures random effect|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed;Region;Total; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.25|0.77|56.53
72342170|NCT02294734|144208235|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.19||||7.29|TWO_SIDED|95.0|0.94|1.5||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; RUL; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.50|0.94|7.29
72342171|NCT02294734|144208235|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.98||||55.09|TWO_SIDED|95.0|0.75|1.28||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; RUL; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.28|0.75|55.09
72342172|NCT02294734|144208235|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.79||||96.49|TWO_SIDED|95.0|0.61|1.02||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; RUL; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.02|0.61|96.49
72342173|NCT02294734|144208235|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.13||||14.54|TWO_SIDED|95.0|0.9|1.44||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; LUL; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.44|0.90|14.54
72342174|NCT02294734|144208235|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.94||||66.85|TWO_SIDED|95.0|0.71|1.25||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; LUL; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.25|0.71|66.85
72342175|NCT02294734|144208235|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.88||||85.77|TWO_SIDED|95.0|0.7|1.11||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; LUL; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.11|0.70|85.77
72342176|NCT02294734|144208235|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.24||||8.67|TWO_SIDED|95.0|0.91|1.7||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; RML; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.70|0.91|8.67
72342177|NCT02294734|144208235|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.22||||14.8|TWO_SIDED|95.0|0.84|1.75||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; RML; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.75|0.84|14.80
72342178|NCT02294734|144208235|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.02||||45.69|TWO_SIDED|95.0|0.75|1.37||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; RML; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.37|0.75|45.69
72342179|NCT02294734|144208235|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.42||||2.94|TWO_SIDED|95.0|0.99|2.06||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; RLL; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||2.06|0.99|2.94
72342180|NCT02294734|144208235|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.22||||13.92|TWO_SIDED|95.0|0.85|1.73||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; RLL; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.73|0.85|13.92
72342181|NCT02294734|144208235|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.86||||86.4|TWO_SIDED|95.0|0.65|1.13||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; RLL; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.13|0.65|86.40
72370061|NCT04154189|144250551|OTHER|Difference and 95% CI: difference of 2 Kaplan-Meier OS-1y rates and corresponding Greenwood standard errors.|Difference in Percentage|-22.9||||0.0352|TWO_SIDED|95.0|-47.6|1.9||One-sided P value|Kaplan Meier Method|||||1.9|-47.6|0.0352
72342182|NCT02294734|144208235|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.46||||0.88|TWO_SIDED|95.0|1.06|2.0||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; LLL; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||2.00|1.06|0.88
72342183|NCT02294734|144208235|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.04||||41.25|TWO_SIDED|95.0|0.75|1.43||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; LLL; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.43|0.75|41.25
72342184|NCT02294734|144208235|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.7||||99.2|TWO_SIDED|95.0|0.52|0.94||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; LLL; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||0.94|0.52|99.20
72342185|NCT02294734|144208235|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.22||||3.49|TWO_SIDED|95.0|0.98|1.51||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Region;Upper; SCRD12 .The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.51|0.98|3.49
72342186|NCT02294734|144208235|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.93||||73.09|TWO_SIDED|95.0|0.72|1.19||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Region;Upper; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.19|0.72|73.09
72342187|NCT02294734|144208235|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.85||||92.41|TWO_SIDED|95.0|0.69|1.06||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Region;Upper; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.06|0.69|92.41
72342188|NCT02294734|144208235|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.38||||2.29|TWO_SIDED|95.0|1.01|1.89||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Region;Lower; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.89|1.01|2.29
72342189|NCT02294734|144208235|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.12||||23.67|TWO_SIDED|95.0|0.81|1.56||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters.Unstructured covariance matrix fitted, accounting for correlation within region and visit|TLC; Scan Trimmed; Region; Lower; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.56|0.81|23.67
72342190|NCT02294734|144208235|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.75||||98.87|TWO_SIDED|95.0|0.59|0.96||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Region;Lower; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||0.96|0.59|98.87
72428626|NCT00518713|144368263|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||ANCOVA with the percent reduction in drop seizures as the dependent variable and treatment, pooled center, and baseline drop seizure rate as the independent variables. A step-down procedure used, starting with the high dose versus placebo.||||<0.0001
72342191|NCT02294734|144208235|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.07||||14.5|TWO_SIDED|95.0|0.95|1.2||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC;Scan Trimmed;Region;Central; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.20|0.95|14.50
72342192|NCT02294734|144208235|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.04||||30.26|TWO_SIDED|95.0|0.91|1.18||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC;Scan Trimmed; Region Central; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.18|0.91|30.26
72428627|NCT00518713|144368264|SUPERIORITY_OR_OTHER|||||||0.1041||95.0|||||ANCOVA|||ANCOVA with the percent reduction in drop seizures as the dependent variable and treatment, pooled center, and baseline drop seizure rate as the independent variables. A step-down procedure used, starting with the high dose versus placebo.||||0.1041
72342193|NCT02294734|144208235|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.98||||62.84|TWO_SIDED|95.0|0.89|1.09||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC;Scan Trimmed;Region Central; D12D28 .The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.09|0.89|62.84
72342194|NCT02294734|144208235|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.31||||2.06|TWO_SIDED|95.0|1.01|1.7||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC;Scan Trimmed; Region;Distal; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.70|1.01|2.06
72342195|NCT02294734|144208235|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.0||||49.97|TWO_SIDED|95.0|0.76|1.32||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC;Scan Trimmed;Region; Distal; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.32|0.76|49.97
72342196|NCT02294734|144208235|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.76||||99.43|TWO_SIDED|95.0|0.62|0.94||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC;Scan Trimmed;Region;Distal; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||0.94|0.62|99.43
72342197|NCT02294734|144208235|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.2||||1.17|TWO_SIDED|95.0|1.02|1.41||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC;Scan Trimmed; Region;Total; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.41|1.02|1.17
72342198|NCT02294734|144208235|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.0||||49.78|TWO_SIDED|95.0|0.84|1.18||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC;Scan Trimmed;Region;Total; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.18|0.84|49.78
72342199|NCT02294734|144208235|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.85||||98.66|TWO_SIDED|95.0|0.73|0.98||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed;Region;Total; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||0.98|0.73|98.66
72342200|NCT02294734|144208236|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.01||||32.51|TWO_SIDED|95.0|0.97|1.06||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC Lobes; RUL; Day 12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.06|0.97|32.51
72342201|NCT02294734|144208236|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.04||||6.21|TWO_SIDED|95.0|0.99|1.08||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC Lobes; RUL Day 28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.08|0.99|6.21
72342202|NCT02294734|144208236|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.02||||15.91|TWO_SIDED|95.0|0.98|1.07||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC Lobes; LUL Day 12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.07|0.98|15.91
72342203|NCT02294734|144208236|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.04||||6.73|TWO_SIDED|95.0|0.99|1.09||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC Lobes;LUL Day 28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.09|0.99|6.73
72342204|NCT02294734|144208236|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.02||||27.65|TWO_SIDED|95.0|0.96|1.07||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC Lobes; RML Day 12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.07|0.96|27.65
72370062|NCT04154189|144250552|OTHER|Difference calculated as Treatment Arm A: Lenvatinib + Ifosfamide + Etoposide minus Treatment Arm B: Ifosfamide + Etoposide. 2-sided 95% CI: Miettinen-Nurminen (Score) confidence limits, stratified by randomization stratification factor age (\<18 and \>=18 years).|Difference in Percentage|7.7|||||TWO_SIDED|95.0|-6.4|22.3||||||||22.3|-6.4|
72342205|NCT02294734|144208236|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.03||||12.19|TWO_SIDED|95.0|0.98|1.07||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC Lobes; RML Day 28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.07|0.98|12.19
72342206|NCT02294734|144208236|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.03||||11.62|TWO_SIDED|95.0|0.98|1.1||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC Lobes; RLL Day 12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.10|0.98|11.62
72342207|NCT02294734|144208236|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.04||||7.66|TWO_SIDED|95.0|0.99|1.1||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC Lobes; RLL Day 28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.10|0.99|7.66
72342208|NCT02294734|144208236|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.01||||28.88|TWO_SIDED|95.0|0.96|1.07||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC Lobes; LLL Day 12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.07|0.96|28.88
72342209|NCT02294734|144208236|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.01||||28.28|TWO_SIDED|95.0|0.96|1.07||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC Lobes; LLL Day 28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.07|0.96|28.28
72342210|NCT02294734|144208236|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.01||||27.87|TWO_SIDED|95.0|0.97|1.05||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC Region; Upper Day 12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.05|0.97|27.87
72342211|NCT02294734|144208236|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.03||||9.83|TWO_SIDED|95.0|0.99|1.07||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.No|FRC Region; Upper Day 28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.07|0.99|9.83
72342212|NCT02294734|144208236|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.02||||21.87|TWO_SIDED|95.0|0.97|1.07||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC Region; Lower Day 12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.07|0.97|21.87
72342213|NCT02294734|144208236|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.02||||18.58|TWO_SIDED|95.0|0.97|1.07||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC Region; Lower Day 28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.07|0.97|18.58
72342214|NCT02294734|144208236|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.02||||22.28|TWO_SIDED|95.0|0.98|1.06||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC Region; Total Day 12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.06|0.98|22.28
72342215|NCT02294734|144208236|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.03||||10.86|TWO_SIDED|95.0|0.98|1.07||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC Region; Total Day 28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.07|0.98|10.86
72342216|NCT02294734|144208236|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.99||||84.89|TWO_SIDED|95.0|0.97|1.01||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC Lobes; RUL; Day 12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.01|0.97|84.89
72370063|NCT04154189|144250553|OTHER|Difference calculated as Treatment Arm A: Lenvatinib + Ifosfamide + Etoposide minus Treatment Arm B: Ifosfamide + Etoposide. 2-sided 95% CI: Miettinen-Nurminen (Score) confidence limits, stratified by randomization stratification factor age (\<18 and \>=18 years).|Difference in Percentage|5.2|||||TWO_SIDED|95.0|-10.3|20.0||||||||20.0|-10.3|
72342217|NCT02294734|144208236|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.0||||63.78|TWO_SIDED|95.0|0.97|1.02||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC Lobes; RUL Day 28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.02|0.97|63.78
72342218|NCT02294734|144208236|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.0||||69.42|TWO_SIDED|95.0|0.98|1.01||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC Lobes; LUL Day 12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.01|0.98|69.42
72342219|NCT02294734|144208236|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.0||||62.63|TWO_SIDED|95.0|0.97|1.02||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC Lobes;LUL Day 28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.02|0.97|62.63
72342220|NCT02294734|144208236|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.99||||72.55|TWO_SIDED|95.0|0.96|1.02||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC Lobes; RML Day 12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.02|0.96|72.55
72342221|NCT02294734|144208236|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.01||||36.28|TWO_SIDED|95.0|0.97|1.04||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC Lobes; RML Day 28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.04|0.97|36.28
72342222|NCT02294734|144208236|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.0||||47.44|TWO_SIDED|95.0|0.96|1.04||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC Lobes; RLL Day 12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.04|0.96|47.44
72342223|NCT02294734|144208236|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.02||||22.99|TWO_SIDED|95.0|0.97|1.06||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC Lobes; RLL Day 28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.06|0.97|22.99
72342224|NCT02294734|144208236|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.98||||85.95|TWO_SIDED|95.0|0.94|1.02||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC Lobes; LLL Day 12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.02|0.94|85.95
72342225|NCT02294734|144208236|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.99||||60.2|TWO_SIDED|95.0|0.96|1.03||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC Lobes; LLL Day 28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.03|0.96|60.20
72342226|NCT02294734|144208236|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.99||||81.34|TWO_SIDED|95.0|0.97|1.01||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC Upper Day 12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.01|0.97|81.34
72342227|NCT02294734|144208236|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.0||||63.04|TWO_SIDED|95.0|0.97|1.02||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC UpperDay 28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.02|0.97|63.04
72342228|NCT02294734|144208236|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.99||||69.67|TWO_SIDED|95.0|0.96|1.03||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC Lower Day 12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.03|0.96|69.67
72370064|NCT02474069|144250559|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.64||||0.087|TWO_SIDED|95.0|0.39|1.07|||ANCOVA|||Logistic regression model: Logit (proportion) = treatment + PASI Score at baseline + PASI score at randomization + error||1.07|0.39|0.087
72370065|NCT02474069|144250560|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.74||||0.281|TWO_SIDED|95.0|0.43|1.28|||ANCOVA|||Logistic regression model: Logit (proportion) = treatment + PASI Score at baseline + PASI score at randomization + error||1.28|0.43|0.281
72342229|NCT02294734|144208236|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.0||||39.81|TWO_SIDED|95.0|0.97|1.04||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC Lower Day 28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.04|0.97|39.81
72342230|NCT02294734|144208236|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.99||||73.01|TWO_SIDED|95.0|0.97|1.02||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC Total Day 12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.02|0.97|73.01
72342231|NCT02294734|144208236|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.0||||48.97|TWO_SIDED|95.0|0.97|1.03||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC Total Day 28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.03|0.97|48.97
72342232|NCT02294734|144208237|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.04||||2.89|TWO_SIDED|95.0|1.0|1.07||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC Length Day 12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.07|1.00|2.89
72342233|NCT02294734|144208237|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.02||||8.49|TWO_SIDED|95.0|0.99|1.05||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC Length Day 28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.05|0.99|8.49
72342234|NCT02294734|144208237|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.02||||86.21|TWO_SIDED|95.0|0.98|1.07||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC Diameter Day 12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.07|0.98|86.21
72342235|NCT02294734|144208237|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.01||||75.2|TWO_SIDED|95.0|0.98|1.05||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC Diameter Day 28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.05|0.98|75.20
72342236|NCT02294734|144208237|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.99||||84.29|TWO_SIDED|95.0|0.97|1.01||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC Length Day 12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.01|0.97|84.29
72342237|NCT02294734|144208237|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.0||||71.08|TWO_SIDED|95.0|0.98|1.01||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC Length Day 28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.01|0.98|71.08
72342238|NCT02294734|144208237|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.0||||34.93|TWO_SIDED|95.0|0.98|1.01||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC Diameter Day 12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.01|0.98|34.93
72342239|NCT02294734|144208237|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.99||||25.05|TWO_SIDED|95.0|0.98|1.01||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC Diameter Day 28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.01|0.98|25.05
72342240|NCT02294734|144208238|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.01||||28.51|TWO_SIDED|95.0|0.97|1.06||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC Length/Diameter Day 12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.06|0.97|28.51
72370066|NCT04173494|144250571|SUPERIORITY||Stratified Cochran-Mantel-Haenszel|15.67||||0.0095|TWO_SIDED|95.0|5.54|25.81|||Cochran-Mantel-Haenszel|||||25.81|5.54|0.0095
72428628|NCT00518713|144368264|SUPERIORITY_OR_OTHER|||||||0.2207||95.0|||||ANCOVA|||ANCOVA with the percent reduction in drop seizures as the dependent variable and treatment, pooled center, and baseline drop seizure rate as the independent variables. A step-down procedure used, starting with the high dose versus placebo.||||0.2207
72342241|NCT02294734|144208238|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.01||||32.15|TWO_SIDED|95.0|0.97|1.05||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC Length/Diameter Day 28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.05|0.97|32.15
72342242|NCT02294734|144208238|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.99||||66.51|TWO_SIDED|95.0|0.97|1.02||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC Length/Diameter Day 12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.02|0.97|66.51
72342243|NCT02294734|144208238|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.0||||45.28|TWO_SIDED|95.0|0.98|1.03||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC Length/Diameter Day 28 The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.03|0.98|45.28
72342244|NCT02294734|144208246|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-2.0||||0.487|TWO_SIDED|95.0|-118.5|115.3|||Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|Day 28|||115.3|-118.5|0.487
72342245|NCT02294734|144208246|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|60.6||||0.816|TWO_SIDED|95.0|-73.3|194.3|||Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|Day 84|||194.3|-73.3|0.816
72342246|NCT02294734|144208249|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-0.144||||0.151|TWO_SIDED|95.0|-0.42|0.133|||Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|Day 28|||0.133|-0.420|0.151
72342247|NCT02294734|144208249|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|0.121||||0.712|TWO_SIDED|95.0|-0.305|0.551|||Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|Day 84|||0.551|-0.305|0.712
72342248|NCT02294734|144208250|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|0.18||||0.817|TWO_SIDED|95.0|-0.216|0.57|||Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|Day 28|||0.570|-0.216|0.817
72342249|NCT02294734|144208250|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|0.114||||0.697|TWO_SIDED|95.0|-0.324|0.549|||Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|Day 84|||0.549|-0.324|0.697
72342250|NCT02294734|144208253|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|1.171||||0.965|TWO_SIDED|95.0|0.988|1.388|||Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.||||1.388|0.988|0.965
72342251|NCT02294734|144208253|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|1.114||||0.913|TWO_SIDED|95.0|0.953|1.305|||Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.||||1.305|0.953|0.913
72342252|NCT00548717|144208259|SUPERIORITY_OR_OTHER|||||||0.77|TWO_SIDED||||||t-test, 2 sided|||Comparison between Grade 0-I aGVHD vs Grade II-IV aGVHD in the Siro/MMF group at week 1.||||0.77
72342253|NCT00548717|144208259|SUPERIORITY_OR_OTHER|||||||0.59|TWO_SIDED||||||t-test, 2 sided|||Comparison between Grade 0-I aGVHD vs Grade II-IV aGVHD in the Siro/MMF group at week 2.||||0.59
72342254|NCT00548717|144208259|SUPERIORITY_OR_OTHER|||||||0.92|TWO_SIDED||||||t-test, 2 sided|||Comparison between Grade 0-I aGVHD vs Grade II-IV aGVHD in the Siro/MMF group at week 3.||||0.92
72342255|NCT00548717|144208259|SUPERIORITY_OR_OTHER|||||||0.63|TWO_SIDED||||||t-test, 2 sided|||Comparison between Grade 0-I aGVHD vs Grade II-IV aGVHD in the Siro/MMF group at week 8.||||0.63
72342256|NCT00548717|144208259|SUPERIORITY_OR_OTHER|||||||0.79|TWO_SIDED||||||t-test, 2 sided|||Comparison between Grade 0-I aGVHD vs Grade II-IV aGVHD in the Siro/MMF group at week 12.||||0.79
72342257|NCT03847909|144208310|SUPERIORITY|P value is from an ANCOVA model with treatment group as the main effect, age category, baseline eGFR category, baseline Uox value as covariates for adjustment.|Difference of Least Mean Square|5171.7|STANDARD_ERROR_OF_MEAN|1144.07|<|0.0001|TWO_SIDED|95.0|2929.3|7414.2|||ANCOVA|||||7414.2|2929.3|<0.0001
72342258|NCT00975143|144208347|NON_INFERIORITY_OR_EQUIVALENCE|Pre-defined criterion for non-inferiority: upper bound of the 95% CI for the treatment difference \< 4.|LS Mean Difference|0.1382||||0.5077|TWO_SIDED|95.0|-0.2712|0.5475||P values are from analysis of covariance (ANCOVA) controlling for Baseline total nodular lesion count, gender and analysis site.|ANCOVA|The 95% CI of the adjusted least square mean difference (CIP-ISOTRETINOIN minus Isotretinoin) was calculated using the ANCOVA model.||Change from Baseline was calculated as the post-Baseline value minus the Baseline value||0.5475|-0.2712|0.5077
72342259|NCT00975143|144208348|NON_INFERIORITY_OR_EQUIVALENCE|If the two co-primary endpoints were significant, a 95% 2 sided CI on the difference between treatments (CIP-Isotretinoin minus Isotretinoin) was calculated.|Proportion difference|-3.48|||>|0.05|TWO_SIDED|95.0|-8.4|1.4|||Normal approximation|95% CI on difference in proportions (CIP-Isotretinoin minus Isotretinoin) was estimated using normal approximation.||The analysis of the secondary efficacy endpoint was based on observed cases only, with no imputation for missing values.||1.4|-8.4|>0.05
72342260|NCT00975143|144208349|NON_INFERIORITY_OR_EQUIVALENCE|Pre-defined criterion for non-inferiority: lower bound of the 95% CI for the treatment difference \> -10.|Proportion difference|-2.1|||>|0.05|TWO_SIDED|95.0|-7.94|3.74|||Normal approximation|||||3.74|-7.94|>0.05
72342261|NCT03322423|144208399|SUPERIORITY|Statistical superiority was concluded if the upper limit of the confidence intervals of the Test lens was below +0.01 logMAR for distance.|Least-Square Mean Estimate|-0.058|STANDARD_ERROR_OF_MEAN|0.0114|||TWO_SIDED|95.0|-0.08|-0.035|||Linear mixed model analysis|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.||||-0.035|-0.080|
72342262|NCT03322423|144208399|SUPERIORITY|Statistical superiority was concluded if the upper limit of the confidence intervals of the Test lens was below +0.01 logMAR for distance.|Least-Square Mean Estimate|-0.076|STANDARD_ERROR_OF_MEAN|0.0114|||TWO_SIDED|95.0|-0.099|-0.054|||Linear mixed model analysis|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.||||-0.054|-0.099|
72342263|NCT03322423|144208400|SUPERIORITY|Statistical superiority was concluded if the upper limit of the confidence intervals of the Test lens was below +0.17 logMAR for near.|LS Mean Estimate|0.141|STANDARD_ERROR_OF_MEAN|0.0147|||TWO_SIDED|95.0|0.112|0.17|||Linear mixed model analysis|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.||||0.170|0.112|
72342264|NCT03322423|144208400|SUPERIORITY|Statistical superiority was concluded if the upper limit of the confidence intervals of the Test lens was below +0.17 logMAR for near.|LS Mean Estimate|0.141|STANDARD_ERROR_OF_MEAN|0.0147|||TWO_SIDED|95.0|0.112|0.17|||Linear mixed model analysis|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.||||0.170|0.112|
72342265|NCT03322423|144208401|SUPERIORITY|Statistical superiority was concluded if the lower limit of the confidence intervals of the Test lens was above 32 CLUE points.|LS Mean Estimate|45.5|STANDARD_ERROR_OF_MEAN|2.19|||TWO_SIDED|95.0|41.2|49.9|||Linear Mixed Model Analysis|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.||||49.9|41.2|
72342266|NCT03322423|144208401|SUPERIORITY|Statistical superiority was concluded if the lower limit of the confidence intervals of the Test lens was above 32 CLUE points.|LS Mean Estimate|46.4|STANDARD_ERROR_OF_MEAN|2.21|||TWO_SIDED|95.0|42.1|50.8|||Linear Mixed Model Analysis|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.||||50.8|42.1|
72342267|NCT02337725|144208402|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-6.39|||<|0.0001|TWO_SIDED|95.0|-8.53|-4.25|||ANCOVA||Estimated Value was reported for the least squares mean difference between TVP-1012 1mg and Placebo (TVP-1012 1mg - Placebo).|||-4.250|-8.530|<0.0001
72342268|NCT01571453|144208422|NON_INFERIORITY_OR_EQUIVALENCE|Vortioxetine was declared to be non-inferior to venlafaxine if the upper limit of the calculated two-sided 95% confidence interval for the treatment difference at Week 8 between vortioxetine and venlafaxine was less than +2.5 MADRS units versus venlafaxine.|Mean Difference (Final Values)|-1.2|STANDARD_ERROR_OF_MEAN|0.93||0.199||95.0|-3.03|0.63||No adjustments for multiple comparisons were made.|ANCOVA|LOCF was used.||The sample size calculation was based on a non-inferiority comparison of the treatment groups in the change from baseline to Week 8 in MADRS total score using a two-sided 95% CI against a margin of +2.5 points. Assuming a standard deviation of 9.0 points and an expected true mean difference between treatments of 0 points, a total of 410 patients (205 per treatment group) were needed to provide a power of 80% for correctly concluding non-inferiority.||0.63|-3.03|0.199
72342269|NCT01571453|144208423|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.15|STANDARD_ERROR_OF_MEAN|0.12||0.228|TWO_SIDED|95.0|-0.39|0.09||No adjustments for multiple comparisons were made.|ANCOVA|LOCF was used.||The same ANCOVA methodology as for the primary endpoint was used.||0.09|-0.39|0.228
72342270|NCT01571453|144208424|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.14|STANDARD_ERROR_OF_MEAN|0.11||0.174|TWO_SIDED|95.0|-0.35|0.06||No adjustments for multiple comparisons were made.|ANCOVA|LOCF was used.||The same ANCOVA methodology as for the primary endpoint was used.||0.06|-0.35|0.174
72342271|NCT01571453|144208425|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.82|STANDARD_ERROR_OF_MEAN|0.65||0.207|TWO_SIDED|95.0|-2.09|0.45||No adjustments for multiple comparisons were made.|ANCOVA|LOCF was used.||The same ANCOVA methodology as for the primary endpoint was used.||0.45|-2.09|0.207
72342272|NCT01571453|144208426|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.25||||0.272||95.0|0.84|1.86||Wald's Test. No adjustments for multiple comparisons were made.|Regression, Logistic|||||1.86|0.84|0.272
72342273|NCT01571453|144208427|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.07||||0.731||95.0|0.73|1.58||Wald's Test. No adjustments for multiple comparisons were made.|Regression, Logistic|||||1.58|0.73|0.731
72342274|NCT00500760|144208442|SUPERIORITY_OR_OTHER||Difference in Kaplan-Meier estimate|-0.07|||||TWO_SIDED|95.0|-0.23|0.09|||||The difference between the treatment groups is calculated as panitumumab plus chemoradiation minus chemoradiotherapy alone.|||0.09|-0.23|
72342275|NCT00500760|144208443|SUPERIORITY_OR_OTHER||Difference in Kaplan-Meier estimate|-0.03|||||TWO_SIDED|95.0|-0.18|0.12|||||The difference between the treatment groups is calculated as panitumumab plus chemoradiation minus chemoradiotherapy alone.|Difference between treatment groups at 6 months||0.12|-0.18|
72342276|NCT00500760|144208443|SUPERIORITY_OR_OTHER||Difference in Kaplan-Meier estimate|-0.03|||||TWO_SIDED|95.0|-1.09|0.12|||||The difference between the treatment groups is calculated as panitumumab plus chemoradiation minus chemoradiotherapy alone.|Difference between treatment groups at 12 months||0.12|-1.09|
72342277|NCT00500760|144208444|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.328||||0.3106|TWO_SIDED|95.0|0.767|2.299|||Regression, Cox||Hazard ratio is presented as panitumumab plus chemoradiation:chemoradiotherapy alone.|||2.299|0.767|0.3106
72342278|NCT00500760|144208445|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.15||||0.6069|TWO_SIDED|95.0|0.675|1.961|||Regression, Cox||Hazard ratio is presented as panitumumab plus chemoradiation:chemoradiotherapy alone.|||1.961|0.675|0.6069
72342279|NCT00500760|144208446|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.628||||0.1223|TWO_SIDED|95.0|0.877|3.019|||Regression, Cox||Hazard ratio is presented as panitumumab plus chemoradiation:chemoradiotherapy alone.|||3.019|0.877|0.1223
72342280|NCT00500760|144208447|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.535||||0.1737|TWO_SIDED|95.0|0.217|1.262|||Regression, Logistic||The odds ratio is defined as the odds of having an overall response in the panitumumab plus chemoradiation arm relative to the odds in the chemoradiotherapy alone arm.|||1.262|0.217|0.1737
72342281|NCT00500760|144208447|SUPERIORITY_OR_OTHER||Difference in rate|-10.99|||||TWO_SIDED|95.0|-24.56|4.14|||||Difference is presented as the rate in panitumumab plus chemoradiation arm minus the rate in chemoradiotherapy alone arm.|||4.14|-24.56|
72342282|NCT00500760|144208448|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.087||||1|TWO_SIDED|95.0|0.448|2.712|||Regression, Logistic||The odds ratio is defined as the odds of having a complete response in the panitumumab plus chemoradiation arm relative to the odds in the chemoradiotherapy alone arm.|||2.712|0.448|1.0000
72342283|NCT00500760|144208448|SUPERIORITY_OR_OTHER||Difference in rate|1.33|||||TWO_SIDED|95.0|-13.23|14.71|||||Difference is presented as the rate in panitumumab plus chemoradiation arm minus the rate in chemoradiotherapy alone arm.|||14.71|-13.23|
72342284|NCT03178669|144208449|SUPERIORITY||Odds Ratio (OR)|2.0||||0.1806|TWO_SIDED|80.0|0.75|5.47||one-sided and adjusted for stratification factors, p values of less than 0.10 were regarded as statistically significant.|Cochran-Mantel-Haenszel|||||5.47|0.75|0.1806
72342285|NCT03178669|144208449|SUPERIORITY||Odds Ratio (OR)|0.7||||0.6649|TWO_SIDED|80.0|0.2|2.24||one-sided and adjusted for stratification factors, p values of less than 0.10 were regarded as statistically significant.|Cochran-Mantel-Haenszel|||||2.24|0.20|0.6649
72342286|NCT03178669|144208449|SUPERIORITY||Odds Ratio (OR)|3.8||||0.0247|TWO_SIDED|80.0|1.53|9.47||one-sided and adjusted for stratification factors, p values of less than 0.10 were regarded as statistically significant.|Cochran-Mantel-Haenszel|||||9.47|1.53|0.0247
72342287|NCT03178669|144208449|SUPERIORITY||Odds Ratio (OR)|1.4||||0.3279|TWO_SIDED|80.0|0.52|3.88||one-sided and adjusted for stratification factors, p values of less than 0.10 were regarded as statistically significant.|Cochran-Mantel-Haenszel|||||3.88|0.52|0.3279
72342288|NCT03178669|144208450|SUPERIORITY||Odds Ratio (OR)|1.9||||0.2115|TWO_SIDED|80.0|0.69|4.99||one-sided and adjusted for stratification factors, p values of less than 0.10 were regarded as statistically significant.|Cochran-Mantel-Haenszel|||||4.99|0.69|0.2115
72342289|NCT03178669|144208450|SUPERIORITY||Odds Ratio (OR)|0.3||||0.8498|TWO_SIDED|80.0|0.06|1.34||one-sided and adjusted for stratification factors, p values of less than 0.10 were regarded as statistically significant.|Cochran-Mantel-Haenszel|||||1.34|0.06|0.8498
72342290|NCT03178669|144208450|SUPERIORITY||Odds Ratio (OR)|2.6||||0.0977|TWO_SIDED|80.0|1.01|6.62||one-sided and adjusted for stratification factors, p values of less than 0.10 were regarded as statistically significant.|Cochran-Mantel-Haenszel|||||6.62|1.01|0.0977
72342291|NCT03178669|144208450|SUPERIORITY||Odds Ratio (OR)|1.0||||0.522|TWO_SIDED|80.0|0.32|2.84||one-sided and adjusted for stratification factors, p values of less than 0.10 were regarded as statistically significant.|Cochran-Mantel-Haenszel|||||2.84|0.32|0.5220
72342292|NCT03178669|144208451|SUPERIORITY||Odds Ratio (OR)|1.5||||0.2335|TWO_SIDED|80.0|0.74|2.94||one-sided and adjusted for stratification factors, p values of less than 0.10 were regarded as statistically significant.|Cochran-Mantel-Haenszel|||||2.94|0.74|0.2335
72342293|NCT03178669|144208451|SUPERIORITY||Odds Ratio (OR)|1.4||||0.2511|TWO_SIDED|80.0|0.73|2.69||one-sided and adjusted for stratification factors, p values of less than 0.10 were regarded as statistically significant.|Cochran-Mantel-Haenszel|||||2.69|0.73|0.2511
72342294|NCT03178669|144208451|SUPERIORITY||Odds Ratio (OR)|1.8||||0.1162|TWO_SIDED|80.0|0.96|3.52||one-sided and adjusted for stratification factors, p values of less than 0.10 were regarded as statistically significant.|Cochran-Mantel-Haenszel|||||3.52|0.96|0.1162
72342295|NCT03178669|144208451|SUPERIORITY||Odds Ratio (OR)|1.2||||0.3467|TWO_SIDED|80.0|0.63|2.4||one-sided and adjusted for stratification factors, p values of less than 0.10 were regarded as statistically significant.|Cochran-Mantel-Haenszel|||||2.40|0.63|0.3467
72342296|NCT03178669|144208452|SUPERIORITY||Odds Ratio (OR)|0.9||||0.6326|TWO_SIDED|80.0|0.5|1.5||one-sided and adjusted for stratification factors, p values of less than 0.10 were regarded as statistically significant.|Cochran-Mantel-Haenszel|||||1.50|0.50|0.6326
72342297|NCT03178669|144208452|SUPERIORITY||Odds Ratio (OR)|0.8||||0.7127|TWO_SIDED|80.0|0.45|1.37||one-sided and adjusted for stratification factors, p values of less than 0.10 were regarded as statistically significant.|Cochran-Mantel-Haenszel|||||1.37|0.45|0.7127
72342298|NCT03178669|144208452|SUPERIORITY||Odds Ratio (OR)|1.3||||0.2658|TWO_SIDED|80.0|0.75|2.34||one-sided and adjusted for stratification factors, p values of less than 0.10 were regarded as statistically significant.|Cochran-Mantel-Haenszel|||||2.34|0.75|0.2658
72342299|NCT03178669|144208452|SUPERIORITY||Odds Ratio (OR)|0.6||||0.8301|TWO_SIDED|80.0|0.36|1.16||one-sided and adjusted for stratification factors, p values of less than 0.10 were regarded as statistically significant.|Cochran-Mantel-Haenszel|||||1.16|0.36|0.8301
72342300|NCT03178669|144208453|SUPERIORITY||Odds Ratio (OR)|0.6||||0.7994|TWO_SIDED|80.0|0.32|1.27||one-sided and adjusted for stratification factors, p values of less than 0.10 were regarded as statistically significant.|Cochran-Mantel-Haenszel|||||1.27|0.32|0.7994
72342301|NCT03178669|144208453|SUPERIORITY||Odds Ratio (OR)|0.3||||0.9665|TWO_SIDED|80.0|0.16|0.72||one-sided and adjusted for stratification factors, p values of less than 0.10 were regarded as statistically significant.|Cochran-Mantel-Haenszel|||||0.72|0.16|0.9665
72342302|NCT03178669|144208453|SUPERIORITY||Odds Ratio (OR)|1.5||||0.2049|TWO_SIDED|80.0|0.8|2.82||one-sided and adjusted for stratification factors, p values of less than 0.10 were regarded as statistically significant.|Cochran-Mantel-Haenszel|||||2.82|0.80|0.2049
72342303|NCT03178669|144208453|SUPERIORITY||Odds Ratio (OR)|0.8||||0.6504|TWO_SIDED|80.0|0.42|1.6||one-sided and adjusted for stratification factors, p values of less than 0.10 were regarded as statistically significant.|Cochran-Mantel-Haenszel|||||1.60|0.42|0.6504
72342304|NCT03178669|144208454|SUPERIORITY||Odds Ratio (OR)|0.4||||0.9207|TWO_SIDED|80.0|0.18|0.93||one-sided and adjusted for stratification factors, p values of less than 0.10 were regarded as statistically significant.|Cochran-Mantel-Haenszel|||||0.93|0.18|0.9207
72342305|NCT03178669|144208454|SUPERIORITY||Odds Ratio (OR)|0.4||||0.9228|TWO_SIDED|80.0|0.19|0.92||one-sided and adjusted for stratification factors, p values of less than 0.10 were regarded as statistically significant.|Cochran-Mantel-Haenszel|||||0.92|0.19|0.9228
72342306|NCT03178669|144208454|SUPERIORITY||Odds Ratio (OR)|0.8||||0.6636|TWO_SIDED|80.0|0.39|1.61||one-sided and adjusted for stratification factors, p values of less than 0.10 were regarded as statistically significant.|Cochran-Mantel-Haenszel|||||1.61|0.39|0.6636
72342307|NCT03178669|144208454|SUPERIORITY||Odds Ratio (OR)|0.7||||0.7449|TWO_SIDED|80.0|0.34|1.41||one-sided and adjusted for stratification factors, p values of less than 0.10 were regarded as statistically significant.|Cochran-Mantel-Haenszel|||||1.41|0.34|0.7449
72342308|NCT01600092|144208455|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority required that the lower bound of the 2-sided 95% confidence interval of the GMT ratio is \>0.67|GMT Ratio (Experimental/Existing)|0.92|||||TWO_SIDED|95.0|0.79|1.07|||||GMTs and GMT ratio were based on a model with terms for treatment and country, with the constraint that the mean baseline value is the same for both treatment groups|Serotype G1||1.07|0.79|
72428629|NCT00518713|144368264|SUPERIORITY_OR_OTHER|||||||0.0025||95.0|||||ANCOVA|||ANCOVA with the percent reduction in drop seizures as the dependent variable and treatment, pooled center, and baseline drop seizure rate as the independent variables. A step-down procedure used, starting with the high dose versus placebo.||||0.0025
72342309|NCT01600092|144208455|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority required that the lower bound of the 2-sided 95% confidence interval of the GMT ratio is \>0.67|GMT Ratio (Experimental/Existing)|1.15|||||TWO_SIDED|95.0|0.99|1.33|||||GMTs and GMT ratio were based on a model with terms for treatment and country, with the constraint that the mean baseline value is the same for both treatment groups|Serotype G2||1.33|0.99|
72342310|NCT01600092|144208455|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority required that the lower bound of the 2-sided 95% confidence interval of the GMT ratio is \>0.67|GMT Ratio (Experimental/Existing)|3.2|||||TWO_SIDED|95.0|2.75|3.74|||||GMTs and GMT ratio were based on a model with terms for treatment and country, with the constraint that the mean baseline value is the same for both treatment groups|Serotype G3||3.74|2.75|
72342311|NCT01600092|144208455|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority required that the lower bound of the 2-sided 95% confidence interval of the GMT ratio is \>0.67|GMT Ratio (Experimental/Existing)|1.06|||||TWO_SIDED|95.0|0.94|1.2|||||GMTs and GMT ratio were based on a model with terms for treatment and country, with the constraint that the mean baseline value is the same for both treatment groups|Serotype G4||1.20|0.94|
72342312|NCT01600092|144208455|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority required that the lower bound of the 2-sided 95% confidence interval of the GMT ratio is \>0.67|GMT Ratio (Experimental/Existing)|1.16|||||TWO_SIDED|95.0|1.0|1.35|||||GMTs and GMT ratio were based on a model with terms for treatment and country, with the constraint that the mean baseline value is the same for both treatment groups|Serotype P1A\[8\]||1.35|1.00|
72342313|NCT00079677|144208460|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.5||||0.0003||95.0|1.67|5.46||The p-value for each treatment group is for the comparison of that treatment group to the placebo treatment group.|ANOVA|||Assumption: both primary treatment comparisons would be with a 2 sided test at an alpha level of 0.05||5.46|1.67|0.0003
72342314|NCT00079677|144208461|SUPERIORITY_OR_OTHER|||||||0.0069||||||The p-value for each treatment group is for the comparison of that treatment group to the placebo treatment group.|Cochran-Mantel-Haenszel|||Assumption: both primary treatment comparisons would be with a 2 sided test at an alpha level of 0.05.||||0.0069
72342315|NCT02641067|144208492|OTHER||Geometric mean ratio|1.43|||||TWO_SIDED|90.0|1.0|2.04||||||||2.04|1.00|
72342316|NCT02641067|144208493|OTHER||Geometric mean ratio|1.38|||||TWO_SIDED|90.0|0.99|1.92||||||||1.92|0.99|
72342317|NCT02641067|144208494|OTHER||Geometric mean ratio|0.83|||||TWO_SIDED|90.0|0.61|1.15||||||||1.15|0.61|
72342318|NCT00279812|144208500|OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
72342319|NCT00279812|144208501|OTHER|||||||0.05|||||||Mixed Models Analysis|||||||0.05
72342320|NCT00279812|144208502|OTHER|||||||0.05|||||||Mixed Models Analysis|||||||0.05
72342321|NCT01439373|144208547|OTHER||Mean posterior difference|0.46|STANDARD_DEVIATION|0.119|||||||||Bayesian probability model|"P1= P(p805 \>pPLC +0.3 \| data)= 0.905. A probability of 95% (P1 \> 0.95) or greater was to be considered 'substantial evidence of superiority."|Posterior Distribution of Difference= p805 - pPLC, where, p805 is the RVR rate for GSK2336805 and pPLC is the RVR rate for Placebo. 95% credible set was defined as the 2.5 and 97.5 percentiles. 95% credible interval for the estimate was 0.22 to 0.68.|||||
72342322|NCT01439373|144208548|OTHER||Mean posterior difference|0.41|STANDARD_DEVIATION|0.122|||||||||Bayesian probability model|"P1= P(p805 \>pPLC +0.3 \| data)= 0.822. A probability of 95% (P1 \> 0.95) or greater was to be considered 'substantial evidence of superiority."|Posterior Distribution of Difference= p805 - pPLC, where, p805 is the RVR rate for GSK2336805 and pPLC is the RVR rate for Placebo. 95% credible set was defined as the 2.5 and 97.5 percentiles. 95% credible interval for the estimate was 0.17 to 0.6|||||
72342323|NCT03281304|144208566|OTHER||Adjusted (weighted) difference|12.9|||||TWO_SIDED|95.0|0.5|25.0||||||Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.||25.0|0.5|
72342324|NCT03281304|144208568|OTHER||Adjusted (weighted) difference|2.9|||||TWO_SIDED|95.0|-7.5|13.4||||||Month 1: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.||13.4|-7.5|
72342325|NCT03281304|144208568|OTHER||Adjusted (weighted) difference|11.4|||||TWO_SIDED|95.0|0.1|22.8||||||Month 3: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.||22.8|0.1|
72342326|NCT03281304|144208568|OTHER||Adjusted (weighted) difference|14.3|||||TWO_SIDED|95.0|2.9|25.2||||||Month 6: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.||25.2|2.9|
72342327|NCT03281304|144208568|OTHER||Adjusted (weighted) difference|20.0|||||TWO_SIDED|95.0|8.0|31.8||||||Month 9: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.||31.8|8.0|
72342328|NCT03281304|144208568|OTHER||Adjusted (weighted) difference|15.7|||||TWO_SIDED|95.0|2.2|28.7||||||Month 12: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.||28.7|2.2|
72342329|NCT03281304|144208568|OTHER||Adjusted (weighted) difference|14.3|||||TWO_SIDED|95.0|0.0|27.9||||||Month 15: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.||27.9|0.0|
72342330|NCT03281304|144208568|OTHER||Adjusted (weighted) difference|14.3|||||TWO_SIDED|95.0|-0.7|28.5||||||Month 18: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.||28.5|-0.7|
72342331|NCT03281304|144208568|OTHER||Adjusted (weighted) difference|7.1|||||TWO_SIDED|95.0|-8.0|21.9||||||Month 21: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.||21.9|-8.0|
72342332|NCT03281304|144208568|OTHER||Adjusted (weighted) difference|5.7|||||TWO_SIDED|95.0|-9.3|20.4||||||Month 24: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.||20.4|-9.3|
72342333|NCT03281304|144208568|OTHER||Adjusted (weighted) difference|8.6|||||TWO_SIDED|95.0|-7.0|23.6||||||Month 27: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.||23.6|-7.0|
72342334|NCT03281304|144208568|OTHER||Adjusted (weighted) difference|2.9|||||TWO_SIDED|95.0|-12.8|18.3||||||Month 30: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.||18.3|-12.8|
72342335|NCT03281304|144208568|OTHER||Adjusted (weighted) difference|1.4|||||TWO_SIDED|95.0|-14.4|17.2||||||Month 33: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.||17.2|-14.4|
72342336|NCT03281304|144208568|OTHER||Adjusted (weighted) difference|2.9|||||TWO_SIDED|95.0|-13.0|18.5||||||Month 36: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.||18.5|-13.0|
72342337|NCT03281304|144208568|OTHER||Adjusted (weighted) difference|-4.3|||||TWO_SIDED|95.0|-20.2|11.9||||||Month 39: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.||11.9|-20.2|
72342338|NCT03281304|144208568|OTHER||Adjusted (weighted) difference|4.3|||||TWO_SIDED|95.0|-11.7|19.9||||||Month 42: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.||19.9|-11.7|
72342339|NCT03281304|144208569|OTHER||Adjusted (weighted) difference|11.4|||||TWO_SIDED|95.0|-1.5|24.1||||||Month 6: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.||24.1|-1.5|
72342340|NCT03281304|144208569|OTHER||Adjusted (weighted) difference|20.0|||||TWO_SIDED|95.0|3.6|35.0||||||Month 18: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.||35.0|3.6|
72342341|NCT03281304|144208569|OTHER||Adjusted (weighted) difference|12.9|||||TWO_SIDED|95.0|-3.5|28.3||||||Month 30: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.||28.3|-3.5|
72342342|NCT03281304|144208569|OTHER||Adjusted (weighted) difference|2.9|||||TWO_SIDED|95.0|-12.5|18.0||||||Month 42: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.||18.0|-12.5|
72342343|NCT03281304|144208570|OTHER||Adjusted (weighted) difference|2.9|||||TWO_SIDED|95.0|-7.5|13.4||||||Month 1: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.||13.4|-7.5|
72342344|NCT03281304|144208570|OTHER||Adjusted (weighted) difference|11.4|||||TWO_SIDED|95.0|0.1|22.8||||||Month 3: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.||22.8|0.1|
72342345|NCT03281304|144208570|OTHER||Adjusted (weighted) difference|14.3|||||TWO_SIDED|95.0|2.4|25.6||||||Month 6: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.||25.6|2.4|
72342346|NCT03281304|144208570|OTHER||Adjusted (weighted) difference|20.0|||||TWO_SIDED|95.0|8.0|31.8||||||Month 9: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.||31.8|8.0|
72342347|NCT03281304|144208570|OTHER||Adjusted (weighted) difference|15.7|||||TWO_SIDED|95.0|2.2|28.7||||||Month 12: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.||28.7|2.2|
72342348|NCT03281304|144208570|OTHER||Adjusted (weighted) difference|14.3|||||TWO_SIDED|95.0|0.0|27.9||||||Month 15: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.||27.9|0.0|
72342349|NCT03281304|144208570|OTHER||Adjusted (weighted) difference|15.7|||||TWO_SIDED|95.0|0.7|29.9||||||Month 18: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.||29.9|0.7|
72342350|NCT03281304|144208570|OTHER||Adjusted (weighted) difference|5.7|||||TWO_SIDED|95.0|-9.5|20.6||||||Month 21: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.||20.6|-9.5|
72342351|NCT03281304|144208570|OTHER||Adjusted (weighted) difference|7.1|||||TWO_SIDED|95.0|-8.0|21.9||||||Month 24: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.||21.9|-8.0|
72342352|NCT03281304|144208570|OTHER||Adjusted (weighted) difference|10.0|||||TWO_SIDED|95.0|-5.7|25.1||||||Month 27: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.||25.1|-5.7|
72342353|NCT03281304|144208570|OTHER||Adjusted (weighted) difference|4.3|||||TWO_SIDED|95.0|-11.4|19.7||||||Month 30: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.||19.7|-11.4|
72342354|NCT03281304|144208570|OTHER||Adjusted (weighted) difference|1.4|||||TWO_SIDED|95.0|-14.4|17.2||||||Month 33: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.||17.2|-14.4|
72342355|NCT03281304|144208570|OTHER||Adjusted (weighted) difference|2.9|||||TWO_SIDED|95.0|-13.0|18.5||||||Month 36: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.||18.5|-13.0|
72342356|NCT03281304|144208570|OTHER||Adjusted (weighted) difference|-2.9|||||TWO_SIDED|95.0|-18.8|13.3||||||Month 39: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.||13.3|-18.8|
72342357|NCT03281304|144208570|OTHER||Adjusted (weighted) difference|2.9|||||TWO_SIDED|95.0|-13.0|18.5||||||Month 42: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.||18.5|-13.0|
72342358|NCT03281304|144208571|OTHER||Adjusted (weighted) difference|15.7|||||TWO_SIDED|95.0|-0.4|30.8||||||Month 18: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.||30.8|-0.4|
72342359|NCT03281304|144208571|OTHER||Adjusted (weighted) difference|12.9|||||TWO_SIDED|95.0|-3.5|28.3||||||Month 30: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.||28.3|-3.5|
72342360|NCT03281304|144208571|OTHER||Adjusted (weighted) difference|1.4|||||TWO_SIDED|95.0|-14.0|16.7||||||Month 42: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.||16.7|-14.0|
72342361|NCT03281304|144208572|OTHER||Mean Difference|-0.3|||||TWO_SIDED|95.0|-0.8|0.1||||||||0.1|-0.8|
72342362|NCT03281304|144208574|OTHER||Least Squares (LS) Mean Difference|0.1|||||TWO_SIDED|95.0|-0.1|0.3||||||Month 1||0.3|-0.1|
72342363|NCT03281304|144208574|OTHER||LS Mean Difference|0.0|||||TWO_SIDED|95.0|-0.2|0.2||||||Month 3||0.2|-0.2|
72342364|NCT03281304|144208574|OTHER||LS Mean Difference|0.0|||||TWO_SIDED|95.0|-0.2|0.3||||||Month 6||0.3|-0.2|
72342365|NCT03281304|144208576|OTHER||LS Mean Difference|-0.6|||||TWO_SIDED|95.0|-1.2|0.1||||||||0.1|-1.2|
72342366|NCT03281304|144208578|OTHER||LS Mean Difference|0.0|||||TWO_SIDED|95.0|-0.3|0.3||||||Month 1||0.3|-0.3|
72342367|NCT03281304|144208578|OTHER||LS Mean Difference|0.0|||||TWO_SIDED|95.0|-0.3|0.2||||||Month 3||0.2|-0.3|
72342368|NCT03281304|144208578|OTHER||LS Mean Difference|0.0|||||TWO_SIDED|95.0|-0.3|0.3||||||Month 6||0.3|-0.3|
72342369|NCT03281304|144208580|OTHER||Adjusted (weighted) difference|11.4|||||TWO_SIDED|95.0|-0.3|23.1||||||Month 6: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.||23.1|-0.3|
72342370|NCT03281304|144208580|OTHER||Adjusted (weighted) difference|18.6|||||TWO_SIDED|95.0|3.5|32.6||||||Month 18: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.||32.6|3.5|
72342371|NCT03281304|144208580|OTHER||Adjusted (weighted) difference|12.9|||||TWO_SIDED|95.0|-3.3|28.1||||||Month 30: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.||28.1|-3.3|
72342372|NCT03281304|144208580|OTHER||Adjusted (weighted) difference|0.0|||||TWO_SIDED|95.0|-16.1|16.1||||||Month 42: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.||16.1|-16.1|
72342373|NCT03281304|144208581|OTHER||Adjusted (weighted) difference|11.4|||||TWO_SIDED|95.0|1.3|22.0||||||Month 6: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.||22.0|1.3|
72342374|NCT03281304|144208581|OTHER||Adjusted (weighted) difference|11.4|||||TWO_SIDED|95.0|-4.2|26.4||||||Month 18: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.||26.4|-4.2|
72342375|NCT03281304|144208581|OTHER||Adjusted (weighted) difference|10.0|||||TWO_SIDED|95.0|-5.8|25.2||||||Month 30: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.||25.2|-5.8|
72342376|NCT03281304|144208581|OTHER||Adjusted (weighted) difference|2.9|||||TWO_SIDED|95.0|-13.0|18.5||||||Month 42: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.||18.5|-13.0|
72428630|NCT00518713|144368265|SUPERIORITY_OR_OTHER|||||||0.1469||95.0|||||ANCOVA|||ANCOVA with the percent reduction in drop seizures as the dependent variable and treatment, pooled center, and baseline drop seizure rate as the independent variables. A step-down procedure used, starting with the high dose versus placebo.||||0.1469
72342377|NCT02020408|144208608|SUPERIORITY||||||>|0.05||||||The p value was calculated and adjusted for multiple comparisons (Bonferroni).|ANOVA|||||||> 0.05
72342378|NCT02020408|144208609|SUPERIORITY||||||<|0.05||||||The p value was calculated and adjusted for multiple comparisons (Bonferroni).|General Linear Model|||A General Linear Model using log(\[11C\]raclopride BPND) after amphetamine administration as dependent variable and Diagnostic Group as independent variable was used. Baseline (before amphetamine administration) \[11C\]raclopride BPND was used as covariate.||||<0.05
72342379|NCT03495102|144208647|SUPERIORITY||Mean Difference (Net)|-0.17||||0.003|TWO_SIDED|95.0|-0.29|-0.06|||Mixed Models Analysis|||||-0.06|-0.29|0.003
72342380|NCT03495102|144208647|SUPERIORITY||Mean Difference (Net)|-0.34|||<|0.001|TWO_SIDED|95.0|-0.45|-0.22|||Mixed Models Analysis|||||-0.22|-0.45|<0.001
72342381|NCT03495102|144208648|SUPERIORITY||Mean Difference (Net)|-0.9||||0.001|TWO_SIDED|95.0|-1.4|-0.4|||Mixed Models Analysis|||||-0.4|-1.4|0.001
72342382|NCT03495102|144208648|SUPERIORITY||Mean Difference (Net)|-1.6|||<|0.001|TWO_SIDED|95.0|-2.1|-1.1|||Mixed Models Analysis|||||-1.1|-2.1|<0.001
72342383|NCT03495102|144208649|SUPERIORITY||Odds Ratio (OR)|1.49||||0.006|TWO_SIDED|95.0|1.12|1.98|||Regression, Logistic|||||1.98|1.12|0.006
72342384|NCT03495102|144208649|SUPERIORITY||Odds Ratio (OR)|2.23|||<|0.001|TWO_SIDED|95.0|1.65|3.01|||Regression, Logistic|||||3.01|1.65|<0.001
72342385|NCT03495102|144208650|SUPERIORITY||Mean Difference (Net)|-3.7||||0.084|TWO_SIDED|95.0|-7.8|0.5|||Mixed Models Analysis|||||0.5|-7.8|0.084
72342386|NCT03495102|144208650|SUPERIORITY||Mean Difference (Net)|-8.1|||<|0.001|TWO_SIDED|95.0|-12.3|-3.9|||Mixed Models Analysis|||||-3.9|-12.3|<0.001
72342387|NCT00321464|144208667|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|A synthesis method was used for the non-inferiority test for the hypothesis that denosumab preserves at least 50% of the effect of zoledronic acid vs. placebo.|Hazard Ratio (HR)|0.82|||<|0.0001||95.0|0.71|0.95|||Regression, Cox||Stratified by the randomization stratification factors (previous skeletal-related event, prior oral bisphosphonate use, current chemotherapy, and location in Japan).|||0.95|0.71|<0.0001
72342388|NCT00321464|144208668|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.82||||0.01||95.0|0.71|0.95||P-value was adjusted for multiplicity according to a hierarchical testing strategy and Hochberg procedure|Regression, Cox||Stratified by the randomization stratification factors (previous skeletal-related event, prior oral bisphosphonate use, current chemotherapy, and location in Japan).|||0.95|0.71|0.010
72342389|NCT00321464|144208669|SUPERIORITY_OR_OTHER_LEGACY||Rate ratio|0.77||||0.001||95.0|0.66|0.89||P-value was adjusted for multiplicity according to a hierarchical testing strategy and Hochberg procedure|Anderson-Gill model||Stratified by the randomization stratification factors (previous skeletal-related event, prior oral bisphosphonate use, current chemotherapy, and location in Japan).|||0.89|0.66|0.001
72342390|NCT04327024|144208670|OTHER||Mean Difference (Final Values)|-0.1||||0.862|TWO_SIDED|95.0|-1.28|1.08|||ANCOVA|Model included change from baseline as the dependent variable, treatment as the independent variable and baseline peak VO2 as covariate.||||1.08|-1.28|0.862
72342391|NCT04327024|144208671|OTHER||Mean Difference (Final Values)|0.44||||0.472|TWO_SIDED|95.0|-0.76|1.64|||ANCOVA|Model included change from baseline as the dependent variable, treatment as the independent variable and baseline peak VO2 as covariate.||||1.64|-0.76|0.472
72342392|NCT04327024|144208672|OTHER||Mean Difference (Final Values)|3.15||||0.287|TWO_SIDED|95.0|-2.65|8.94|||Mixed Models Analysis|Model included treatment as the independent variable and visit, visit by treatment, and baseline KCCQ-TSS as covariates.||"H0: Difference in mean change from baseline in KCCQ-TSS (verinurad + allopurinol vs placebo) = 0 Ha: Difference in mean change from baseline in KCCQ-TSS (verinurad + allopurinol vs placebo) ≠ 0~A hierarchical test sequence was used for the confirmatory analysis of the primary and secondary objectives in order to address the issue of multiple testing and control the Type I error rate at an overall two-sided 0.05 level."||8.94|-2.65|0.287
72428631|NCT00518713|144368265|SUPERIORITY_OR_OTHER|||||||0.0161||95.0|||||ANCOVA|||ANCOVA with the percent reduction in drop seizures as the dependent variable and treatment, pooled center, and baseline drop seizure rate as the independent variables. A step-down procedure used, starting with the high dose versus placebo.||||0.0161
72428632|NCT00518713|144368265|SUPERIORITY_OR_OTHER|||||||0.0024||95.0|||||ANCOVA|||ANCOVA with the percent reduction in drop seizures as the dependent variable and treatment, pooled center, and baseline drop seizure rate as the independent variables. A step-down procedure used, starting with the high dose versus placebo.||||0.0024
72342393|NCT04327024|144208673|OTHER||Mean Difference (Final Values)|-0.15||||0.96|TWO_SIDED|95.0|-5.9|5.61|||Mixed Models Analysis|Model included treatment as the independent variable and visit, visit by treatment, and baseline KCCQ-TSS as covariates.||"H0: Difference in mean change from baseline in KCCQ-TSS (verinurad + allopurinol vs allopurinol) = 0 Ha: Difference in mean change from baseline in KCCQ-TSS (verinurad + allopurinol vs allopurinol) ≠ 0~A hierarchical test sequence was used for the confirmatory analysis of the primary and secondary objectives in order to address the issue of multiple testing and control the Type I error rate at an overall two-sided 0.05 level."||5.61|-5.90|0.960
72342394|NCT01192568|144208677|SUPERIORITY||Mean Difference (Final Values)|14.22|STANDARD_ERROR_OF_MEAN|4.612||0.0928|TWO_SIDED|95.0|-2.45|30.9|||ANCOVA|||||30.90|-2.45|0.0928
72342395|NCT01192568|144208678|SUPERIORITY||Mean Difference (Final Values)|34.92|STANDARD_ERROR_OF_MEAN|8.089||0.0054|TWO_SIDED|95.0|11.13|58.7|||ANCOVA|||||58.70|11.13|0.0054
72342396|NCT01192568|144208679|SUPERIORITY||Mean Difference (Final Values)|32.59|STANDARD_ERROR_OF_MEAN|13.215||0.1739|TWO_SIDED|95.0|-14.89|80.07|||ANCOVA|||||80.07|-14.89|0.1739
72342397|NCT01192568|144208680|SUPERIORITY||Mean Difference (Final Values)|-0.19|STANDARD_ERROR_OF_MEAN|0.117||0.266|TWO_SIDED|95.0|-0.53|0.15|||ANCOVA|||Results from a pre-specified test (Kolmogorov-Smirnov test p \<= 0.05) determined that the Pre-Am3 and Post-Am3 OTG data should be analyzed separately for the primary analysis.||0.15|-0.53|0.2660
72342398|NCT01192568|144208680|SUPERIORITY||Mean Difference (Final Values)|-0.67||||0.007|TWO_SIDED|95.0|-1.13|-0.21|||t-test, 2 sided|||||-0.21|-1.13|0.0070
72342399|NCT00652951|144208681|NON_INFERIORITY|Non-inferiority criteria: The upper limit (UL) of the 2-sided 95% confidence interval (CI) of the GMC ratio for between groups (Synflorix + Infanrix hexa Group over Synflorix + Pediacel Group), was lower than 2 for the pneumococcal vaccine serotype 1.|GMC ratio|0.89|||||TWO_SIDED|95.0|0.74|1.07|||ANOVA|||The 2-sided 95% confidence interval (CI) of the geometric mean concentration (GMC) ratio between the Synflorix + Infanrix hexa and Synflorix + Pediacel groups (Synflorix + Infanrix hexa Group over Synflorix + Pediacel Group), at one month after Dose 3 of pneumococcal vaccine, was computed for each of the 10 pneumococcal vaccine serotypes and protein D. This statistical method concerns pneumococcal vaccine serotype 1.||1.07|0.74|
72342400|NCT00652951|144208681|NON_INFERIORITY|Non-inferiority criteria: The upper limit (UL) of the 2-sided 95% CI of the GMC ratio for between groups (Synflorix + Infanrix hexa Group over Synflorix + Pediacel Group), was lower than 2 for the pneumococcal vaccine serotype 4.|GMC ratio|1.01|||||TWO_SIDED|95.0|0.84|1.23|||ANOVA|||The 2-sided 95% CI of the geometric mean concentration (GMC) ratio between the Synflorix + Infanrix hexa and Synflorix + Pediacel groups (Synflorix + Infanrix hexa Group over Synflorix + Pediacel Group), at one month after Dose 3 of pneumococcal vaccine, was computed for each of the 10 pneumococcal vaccine serotypes and protein D. This statistical method concerns pneumococcal vaccine serotype 4.||1.23|0.84|
72342401|NCT00652951|144208681|NON_INFERIORITY|Non-inferiority criteria: The upper limit (UL) of the 2-sided 95% CI of the GMC ratio for between groups (Synflorix + Infanrix hexa Group over Synflorix + Pediacel Group), was lower than 2 for the pneumococcal vaccine serotype 5.|GMC ratio|0.98|||||TWO_SIDED|95.0|0.83|1.15|||ANOVA|||The 2-sided 95% CI of the geometric mean concentration (GMC) ratio between the Synflorix + Infanrix hexa and Synflorix + Pediacel groups (Synflorix + Infanrix hexa Group over Synflorix + Pediacel Group), at one month after Dose 3 of pneumococcal vaccine, was computed for each of the 10 pneumococcal vaccine serotypes and protein D. This statistical method concerns pneumococcal vaccine serotype 5.||1.15|0.83|
72342402|NCT00652951|144208681|NON_INFERIORITY|Non-inferiority criteria: The upper limit (UL) of the 2-sided 95% CI of the GMC ratio for between groups (Synflorix + Infanrix hexa Group over Synflorix + Pediacel Group), was lower than 2 for the pneumococcal vaccine serotype 6B.|GMC ratio|0.93|||||TWO_SIDED|95.0|0.69|1.26|||ANOVA|||The 2-sided 95% CI of the geometric mean concentration (GMC) ratio between the Synflorix + Infanrix hexa and Synflorix + Pediacel groups (Synflorix + Infanrix hexa Group over Synflorix + Pediacel Group), at one month after Dose 3 of pneumococcal vaccine, was computed for each of the 10 pneumococcal vaccine serotypes and protein D. This statistical method concerns pneumococcal vaccine serotype 6B.||1.26|0.69|
72342403|NCT00652951|144208681|NON_INFERIORITY|Non-inferiority criteria: The upper limit of the 2-sided 95% CI of the GMC ratio for between groups (Synflorix + Infanrix hexa Group over Synflorix + Pediacel Group Group), was lower than 2 for the pneumococcal vaccine serotype 7F.|GMC ratio|0.96|||||TWO_SIDED|95.0|0.82|1.13|||ANOVA|||The 2-sided 95% CI of the geometric mean concentration (GMC) ratio between the Synflorix + Infanrix hexa and Synflorix + Pediacel Group groups (Synflorix + Infanrix hexa Group over Synflorix + Pediacel Group), at one month after Dose 3 of pneumococcal vaccine, was computed for each of the 10 pneumococcal vaccine serotypes and protein D. This statistical method concerns pneumococcal vaccine serotype 7F.||1.13|0.82|
72342404|NCT00652951|144208681|NON_INFERIORITY|Non-inferiority criteria: The upper limit (UL) of the 2-sided 95% CI of the GMC ratio for between groups (Synflorix + Infanrix hexa Group over Synflorix + Pediacel Group), was lower than 2 for the pneumococcal vaccine serotype 9V.|GMC ratio|0.95|||||TWO_SIDED|95.0|0.78|1.16|||ANOVA|||The 2-sided 95% CI of the geometric mean concentration (GMC) ratio between the Synflorix + Infanrix hexa and Synflorix + Pediacel groups (Synflorix + Infanrix hexa Group over Synflorix + Pediacel Group), at one month after Dose 3 of pneumococcal vaccine, was computed for each of the 10 pneumococcal vaccine serotypes and protein D. This statistical method concerns pneumococcal vaccine serotype 9V.||1.16|0.78|
72342405|NCT00652951|144208681|NON_INFERIORITY|Non-inferiority criteria: The upper limit (UL) of the 2-sided 95% CI of the GMC ratio for between groups (Synflorix + Infanrix hexa Group over Synflorix + Pediacel Group), was lower than 2 for the pneumococcal vaccine serotype 14.|GMC ratio|1.01|||||TWO_SIDED|95.0|0.85|1.21|||ANOVA|||The 2-sided 95% CI of the geometric mean concentration (GMC) ratio between the Synflorix + Infanrix hexa and Synflorix + Pediacel groups (Synflorix + Infanrix hexa Group over Synflorix + Pediacel Group), at one month after Dose 3 of pneumococcal vaccine, was computed for each of the 10 pneumococcal vaccine serotypes and protein D. This statistical method concerns pneumococcal vaccine serotype 14.||1.21|0.85|
72342406|NCT00652951|144208681|NON_INFERIORITY|Non-inferiority criteria: The upper limit (UL) of the 2-sided 95% CI of the GMC ratio for between groups (Synflorix + Infanrix hexa Group over Synflorix + Pediacel Group), was lower than 2 for the pneumococcal vaccine serotype 18C.|GMC ratio|1.61|||||TWO_SIDED|95.0|1.28|2.03|||ANOVA|||The 2-sided 95% CI of the geometric mean concentration (GMC) ratio between the Synflorix + Infanrix hexa and Synflorix + Pediacel groups (Synflorix + Infanrix hexa Group over ), at one month after Dose 3 of pneumococcal vaccine, was computed for each of the 10 pneumococcal vaccine serotypes and protein D. This statistical method concerns pneumococcal vaccine serotype 18C.||2.03|1.28|
72342407|NCT00652951|144208681|NON_INFERIORITY|Non-inferiority criteria: The upper limit (UL) of the 2-sided 95% CI of the GMC ratio for between groups (Synflorix + Infanrix hexa Group over Synflorix + Pediacel Group), was lower than 2 for the pneumococcal vaccine serotype 19F.|GMC ratio|1.06|||||TWO_SIDED|95.0|0.82|1.36|||ANOVA|||The 2-sided 95% CI of the geometric mean concentration (GMC) ratio between the Synflorix + Infanrix hexa and Synflorix + Pediacel groups (Synflorix + Infanrix hexa Group over Synflorix + Pediacel Group), at one month after Dose 3 of pneumococcal vaccine, was computed for each of the 10 pneumococcal vaccine serotypes and protein D. This statistical method concerns pneumococcal vaccine serotype 19F.||1.36|0.82|
72342408|NCT00652951|144208681|NON_INFERIORITY|Non-inferiority criteria: The upper limit (UL) of the 2-sided 95% CI of the GMC ratio for between groups (Synflorix + Infanrix hexa Group Group over Synflorix + Pediacel Group), was lower than 2 for the pneumococcal vaccine serotype 23F.|GMC ratio|0.92|||||TWO_SIDED|95.0|0.7|1.23|||ANOVA|||The 2-sided 95% CI of the geometric mean concentration (GMC) ratio between the Synflorix + Infanrix hexa Group and Synflorix + Pediacel groups (Synflorix + Infanrix hexa Group Group over Synflorix + Pediacel Group), at one month after Dose 3 of pneumococcal vaccine, was computed for each of the 10 pneumococcal vaccine serotypes and protein D. This statistical method concerns pneumococcal vaccine serotype 23F.||1.23|0.7|
72342409|NCT00652951|144208682|NON_INFERIORITY|Non-inferiority criteria: The upper limit (UL) of the 2-sided 95% CI of the GMC ratio for between groups (Synflorix + Infanrix hexa Group over Synflorix + Pediacel Group), was lower than 2 for protein D.|GMC ratio|0.91|||||TWO_SIDED|95.0|0.77|1.06|||ANOVA|||The 2-sided 95% CI of the geometric mean concentration (GMC) ratio between the Synflorix + Infanrix hexa and Synflorix + Pediacel groups (Synflorix + Infanrix hexa Group over Synflorix + Pediacel Group), at one month after Dose 3 of pneumococcal vaccine, was computed for each of the 10 pneumococcal vaccine serotypes and protein D. This statistical method concerns protein D.||1.06|0.77|
72342410|NCT02593825|144208724|SUPERIORITY|Significance was based on α = .05. Hedges' g, corrected for small sample bias, was calculated as a measure of effect size using the model-predicted group differences in rate of change in the numerator and the pooled standard deviation estimated from the 3 or 12 month assessment (for short- and long-term effects, respectively) in the denominator.|Slope|1.14|||<|0.05|TWO_SIDED|||||Piecewise linear mixed modeling (LMM) was performed to address the study questions. LMM was necessary to account for repeated measures nested within children.|Mixed Models Analysis|||Also examined these groups in sub-groups of mildly delayed (\<2.5 Standard Deviations below the mean on motor Bayley score at baseline) and significantly motor delayed (\>2.5 Standard Deviations below the mean on motor Bayley score at baseline)|Piecewise modeling, using individually-varying timepoints, allowed separate slopes to be estimated across the intervention (baseline to 3 months) and post-intervention (3 to 12 months) phases, and accounted for variation in the time between assessments across children. All models controlled for intercept-level differences by site, as well as intercept- and slope-level differences by baseline-adjusted age and motor severity. Intervention effects were derived via intervention by slope interaction terms. Three-way interaction terms were subsequently added to the models to obtain intervention effects stratified by severity.|||<0.05
72342411|NCT02593825|144208725|SUPERIORITY||Mean Difference (Final Values)|0.192||||0.05|TWO_SIDED||||||Linear piecewise modeling|||||||.05
72342412|NCT02593825|144208726|SUPERIORITY||Slope|0.92|STANDARD_ERROR_OF_MEAN|0.47|<|0.05|TWO_SIDED||||||Mixed Models Analysis||data shown is for the 12 month time point for the severely delayed group comparison|Also examined these groups in sub-groups of mildly delayed (\<2.5 Standard Deviations below the mean on motor Bayley score at baseline) and significantly motor delayed (\>2.5 Standard Deviations below the mean on motor Bayley score at baseline)||||<0.05
72342413|NCT02593825|144208728|SUPERIORITY||Slope|1.02|||<|0.05|TWO_SIDED||||||Mixed Models Analysis|||Also examined these groups in sub-groups of mildly delayed (\<2.5SD below the mean on motor Bayley score at baseline) and significantly motor delayed (\>2.5SD below the mean on motor Bayley score at baseline)|LMM was necessary to account for repeated measures nested within children. Piecewise modeling, using individually-varying timepoints, allowed separate slopes to be estimated across the intervention (baseline to 3 months).|||<0.05
72342414|NCT02593825|144208729|SUPERIORITY||Slope|8.7|||<|0.05|TWO_SIDED||||||Mixed Models Analysis|||Also examined these groups in sub-groups of mildly delayed (\<2.5SD below the mean on motor Bayley score at baseline) and significantly motor delayed (\>2.5SD below the mean on motor Bayley score at baseline)|Piecewise modeling, using individually-varying timepoints, allowed separate slopes to be estimated across the intervention (baseline to 3 months)|||<0.05
72342415|NCT02593825|144208730|SUPERIORITY||Mean Difference (Final Values)|0.01||||0.417|TWO_SIDED||||||Mixed Models Analysis|||||||0.417
72342416|NCT01206582|144208732|SUPERIORITY_OR_OTHER|||||||0.0002|TWO_SIDED||||||ANCOVA|||Comparison for day 3||||0.0002
72342417|NCT01206582|144208732|SUPERIORITY_OR_OTHER|||||||0.008|TWO_SIDED||||||ANCOVA|||Comparison for day 7||||0.008
72342418|NCT01206582|144208733|SUPERIORITY_OR_OTHER|||||||0.0003|TWO_SIDED||||||ANCOVA|||Comparison for day 3||||0.0003
72342419|NCT01206582|144208740|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||ANCOVA|||Comparison for Day 7||||<0.05
72342420|NCT01206582|144208741|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||ANCOVA|||Comparison for Day 7||||<0.05
72342421|NCT01206582|144208742|SUPERIORITY_OR_OTHER|||||||0.01|TWO_SIDED||||||ANCOVA|||Comparison for Platelets on Day 4||||0.01
72342422|NCT01209078|144208769|SUPERIORITY_OR_OTHER||Difference|-22.2|||||||||||Regression, Logistic|||GSK1322322 1500 mg versus Linezolid 600 mg for end of therapy Clinical Success.||||
72342423|NCT01209078|144208769|SUPERIORITY_OR_OTHER||Difference|-24.0|||||||||||Regression, Logistic|||GSK1322322 1500 mg versus Linezolid 600 mg for Follow-up Clinical Success.||||
72342424|NCT01209078|144208770|SUPERIORITY_OR_OTHER||Difference|-35.0|||||TWO_SIDED|95.0|-60.6|-9.4|||Regression, Logistic|||||-9.4|-60.6|
72342425|NCT01209078|144208771|SUPERIORITY_OR_OTHER||Difference|-35.0|||||TWO_SIDED|95.0|-60.6|-9.4|||Regression, Logistic|||||-9.4|-60.6|
72342426|NCT01209078|144208774|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.17|||||TWO_SIDED|95.0|-0.41|0.74|||Mixed Models Analysis|||GSK1322322 1500 mg versus Linezolid 600 mg for Day 2 exudate or pus score.||0.74|-0.41|
72342427|NCT01209078|144208774|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.12|||||TWO_SIDED|95.0|-0.7|0.45|||Mixed Models Analysis||The point estimate was calculated as least square mean difference (final values) of GSK1322322 1500 mg and Linezolid 600 mg.|GSK1322322 1500 mg versus Linezolid 600 mg for Day 3 exudate or pus score.||0.45|-0.70|
72342428|NCT01209078|144208774|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.16|||||TWO_SIDED|95.0|-0.74|0.43|||Mixed Models Analysis||The point estimate was calculated as least square mean difference (final values) of GSK1322322 1500 mg and Linezolid 600 mg.|GSK1322322 1500 mg versus Linezolid 600 mg for Day 4 exudate or pus score.||0.43|-0.74|
72342429|NCT01209078|144208774|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.35|||||TWO_SIDED|95.0|-0.25|0.95|||Mixed Models Analysis||The point estimate was calculated as least square mean difference (final values) of GSK1322322 1500 mg and Linezolid 600 mg.|GSK1322322 1500 mg versus Linezolid 600 mg for Day 8 exudate or pus score.||0.95|-0.25|
72342430|NCT01209078|144208774|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.11|||||TWO_SIDED|95.0|-0.49|0.72|||Mixed Models Analysis||The point estimate was calculated as least square mean difference (final values) of GSK1322322 1500 mg and Linezolid 600 mg.|GSK1322322 1500 mg versus Linezolid 600 mg for Day 11 exudate or pus score.||0.72|-0.49|
72342431|NCT01209078|144208774|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.06|||||TWO_SIDED|95.0|-0.53|0.66|||Mixed Models Analysis||The point estimate was calculated as least square mean difference (final values) of GSK1322322 1500 mg and Linezolid 600 mg.|GSK1322322 1500 mg versus Linezolid 600 mg for 7 Day Follow- up exudate or pus score.||0.66|-0.53|
72342432|NCT01209078|144208774|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.03|||||TWO_SIDED|95.0|-0.65|0.58|||Mixed Models Analysis||The point estimate was calculated as least square mean difference (final values) of GSK1322322 1500 mg and Linezolid 600 mg.|GSK1322322 1500 mg versus Linezolid 600 mg for 28 Day Follow- up exudate or pus score.||0.58|-0.65|
72342433|NCT01209078|144208775|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.86|||||TWO_SIDED|95.0|-3.04|1.33|||Mixed Models Analysis||The point estimate was calculated as least square mean difference (final values) of GSK1322322 1500 mg and Linezolid 600 mg.|GSK1322322 1500 mg versus Linezolid 600 mg for Day 2 total SIS.||1.33|-3.04|
72342434|NCT01209078|144208775|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.77|||||TWO_SIDED|95.0|-2.94|1.41|||Mixed Models Analysis||The point estimate was calculated as least square mean difference (final values) of GSK1322322 1500 mg and Linezolid 600 mg.|GSK1322322 1500 mg versus Linezolid 600 mg for Day 3 total SIS.||1.41|-2.94|
72342435|NCT01209078|144208775|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.54|||||TWO_SIDED|95.0|-1.68|2.75|||||The point estimate was calculated as least square mean difference (final values) of GSK1322322 1500 mg and Linezolid 600 mg.|GSK1322322 1500 mg versus Linezolid 600 mg for Day 4 total SIS.||2.75|-1.68|
72342436|NCT01209078|144208775|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.79|||||TWO_SIDED|95.0|-0.46|4.05|||Mixed Models Analysis||The point estimate was calculated as least square mean difference (final values) of GSK1322322 1500 mg and Linezolid 600 mg.|GSK1322322 1500 mg versus Linezolid 600 mg for Day 8 total SIS.||4.05|-0.46|
72342437|NCT01209078|144208775|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.19|||||TWO_SIDED|95.0|-1.09|3.47|||Mixed Models Analysis||The point estimate was calculated as least square mean difference (final values) of GSK1322322 1500 mg and Linezolid 600 mg.|GSK1322322 1500 mg versus Linezolid 600 mg for Day 11 total SIS.||3.47|-1.09|
72342438|NCT01209078|144208775|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.74|||||TWO_SIDED|95.0|-1.49|2.98|||Mixed Models Analysis||The point estimate was calculated as least square mean difference (final values) of GSK1322322 1500 mg and Linezolid 600 mg.|GSK1322322 1500 mg versus Linezolid 600 mg for 7 Day Follow-up total SIS.||2.98|-1.49|
72342439|NCT01209078|144208775|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.21|||||TWO_SIDED|95.0|-2.09|2.52|||Mixed Models Analysis||The point estimate was calculated as least square mean difference (final values) of GSK1322322 1500 mg and Linezolid 600 mg.|GSK1322322 1500 mg versus Linezolid 600 mg for 28 Day Follow-up total SIS.||2.52|-2.09|
72342440|NCT01209078|144208776|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.86|||||TWO_SIDED|95.0|-3.04|1.33|||Mixed Models Analysis||The point estimate was calculated as least square mean difference (net values) of GSK1322322 1500 mg and Linezolid 600 mg.|GSK1322322 1500 mg versus Linezolid 600 mg for Day 2 total SIS.||1.33|-3.04|
72342441|NCT01209078|144208776|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.77|||||TWO_SIDED|95.0|-2.94|1.41|||Mixed Models Analysis||The point estimate was calculated as least square mean difference (net values) of GSK1322322 1500 mg and Linezolid 600 mg.|GSK1322322 1500 mg versus Linezolid 600 mg for Day 3 total SIS.||1.41|-2.94|
72342442|NCT01209078|144208776|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.54|||||TWO_SIDED|95.0|-1.68|2.75|||Mixed Models Analysis||The point estimate was calculated as least square mean difference (net values) of GSK1322322 1500 mg and Linezolid 600 mg.|GSK1322322 1500 mg versus Linezolid 600 mg for Day 4 total SIS.||2.75|-1.68|
72342443|NCT01209078|144208776|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.79|||||TWO_SIDED|95.0|-0.46|4.05|||Mixed Models Analysis||The point estimate was calculated as least square mean difference (net values) of GSK1322322 1500 mg and Linezolid 600 mg.|GSK1322322 1500 mg versus Linezolid 600 mg for Day 8 total SIS.||4.05|-0.46|
72342444|NCT01209078|144208776|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.19|||||TWO_SIDED|95.0|-1.09|3.47|||Mixed Models Analysis||The point estimate was calculated as least square mean difference (net values) of GSK1322322 1500 mg and Linezolid 600 mg.|GSK1322322 1500 mg versus Linezolid 600 mg for Day 11 total SIS.||3.47|-1.09|
72342445|NCT01209078|144208776|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.74|||||TWO_SIDED|95.0|-1.49|2.98|||Mixed Models Analysis||The point estimate was calculated as least square mean difference (net values) of GSK1322322 1500 mg and Linezolid 600 mg.|GSK1322322 1500 mg versus Linezolid 600 mg for 7 Day Follow-up total SIS.||2.98|-1.49|
72342446|NCT01209078|144208776|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.21|||||TWO_SIDED|95.0|-2.09|2.52|||Mixed Models Analysis||The point estimate was calculated as least square mean difference (net values) of GSK1322322 1500 mg and Linezolid 600 mg.|GSK1322322 1500 mg versus Linezolid 600 mg for 28 Day Follow-up total SIS.||2.52|-2.09|
72342447|NCT01209078|144208777|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-68.85|||||TWO_SIDED|95.0|-132.8|-4.95|||Mixed Models Analysis||The point estimate was calculated as least square mean difference (net values) of GSK1322322 1500 mg and Linezolid 600 mg.|GSK1322322 1500 mg versus Linezolid 600 mg for Day 2 wound area.||-4.95|-132.8|
72342448|NCT01209078|144208777|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.06|||||TWO_SIDED|95.0|-66.54|60.43|||Mixed Models Analysis||The point estimate was calculated as least square mean difference (net values) of GSK1322322 1500 mg and Linezolid 600 mg.|GSK1322322 1500 mg versus Linezolid 600 mg for Day 3 wound area.||60.43|-66.54|
72342449|NCT01209078|144208777|SUPERIORITY_OR_OTHER||Median Difference (Net)|31.47|||||TWO_SIDED|95.0|-33.53|96.47|||Mixed Models Analysis||The point estimate was calculated as least square mean difference (net values) of GSK1322322 1500 mg and Linezolid 600 mg.|GSK1322322 1500 mg versus Linezolid 600 mg for Day 4 wound area.||96.47|-33.53|
72342450|NCT01209078|144208777|SUPERIORITY_OR_OTHER||Mean Difference (Net)|43.94|||||TWO_SIDED|95.0|-22.43|110.31|||Mixed Models Analysis||The point estimate was calculated as least square mean difference (net values) of GSK1322322 1500 mg and Linezolid 600 mg.|GSK1322322 1500 mg versus Linezolid 600 mg for Day 8 wound area.||110.31|-22.43|
72342451|NCT01209078|144208777|SUPERIORITY_OR_OTHER||Mean Difference (Net)|34.21|||||TWO_SIDED|95.0|-33.03|101.45|||Mixed Models Analysis||The point estimate was calculated as least square mean difference (net values) of GSK1322322 1500 mg and Linezolid 600 mg.|GSK1322322 1500 mg versus Linezolid 600 mg for Day 11 wound area.||101.45|-33.03|
72342452|NCT01209078|144208777|SUPERIORITY_OR_OTHER||Mean Difference (Net)|37.57|||||TWO_SIDED|95.0|-28.25|103.4|||Mixed Models Analysis||The point estimate was calculated as least square mean difference (net values) of GSK1322322 1500 mg and Linezolid 600 mg.|GSK1322322 1500 mg versus Linezolid 600 mg for 7 Day Follow-up wound area.||103.40|-28.25|
72342453|NCT01209078|144208777|SUPERIORITY_OR_OTHER||Mean Difference (Net)|37.4|||||TWO_SIDED|95.0|-30.77|105.56|||Mixed Models Analysis||The point estimate was calculated as least square mean difference (net values) of GSK1322322 1500 mg and Linezolid 600 mg.|GSK1322322 1500 mg versus Linezolid 600 mg for 28 Day Follow-up wound area.||105.56|-30.77|
72342454|NCT01209078|144208778|SUPERIORITY_OR_OTHER||Difference|-35.4|||||||||||Regression, Logistic|||GSK1322322 1500 mg versus Linezolid 600 mg for Staphylococcus aureus (all).||||
72342455|NCT01209078|144208778|SUPERIORITY_OR_OTHER||Difference|-37.5|||||||||||Regression, Logistic|||GSK1322322 1500 mg versus Linezolid 600 mg for MRSA.||||
72342456|NCT01209078|144208778|SUPERIORITY_OR_OTHER||Difference|-28.6|||||||||||Regression, Logistic|||GSK1322322 1500 mg versus Linezolid 600 mg for MSSA.||||
72342457|NCT01209078|144208778|SUPERIORITY_OR_OTHER||Difference|-66.7|||||||||||Regression, Logistic|||GSK1322322 1500 mg versus Linezolid 600 mg for Streptococcus pyogenes.||||
72342458|NCT01209078|144208778|SUPERIORITY_OR_OTHER||Difference|-25.0|||||||||||Regression, Logistic|||GSK1322322 1500 mg versus Linezolid 600 mg for Gram-negative pathogens.||||
72342459|NCT01209078|144208778|SUPERIORITY_OR_OTHER||Difference|-37.5|||||||||||Regression, Logistic|||GSK1322322 1500 mg versus Linezolid 600 mg for All pathogens.||||
72342460|NCT01209078|144208778|SUPERIORITY_OR_OTHER||Difference|2.2|||||||||||Regression, Logistic|||GSK1322322 1500 mg versus Linezolid 600 mg for No pathogens.||||
72342461|NCT00924508|144208780|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||Baseline and post-treatment comparison||||<0.001
72342462|NCT00924508|144208780|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||Baseline and post-treatment comparison||||<0.001
72342463|NCT00924508|144208780|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||Baseline and post-treatment comparison||||<0.001
72342464|NCT01755455|144208782|SUPERIORITY_OR_OTHER|||||||0.81|||||||Fixed-effect model|||Fixed-effect models accounted for repeated measurements within subjects and treatment sequence. The estimated effect signifies the absolute change from baseline at 6 weeks in the specified outcome measure and (standard error).||||0.81
72342465|NCT01755455|144208783|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Fixed-effect model|||||||<0.05
72342466|NCT01755455|144208784|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Fixed-effect model|||Fixed-effect models accounted for repeated measurements within subjects and treatment sequence. The estimated effect signifies the absolute change from baseline at 6 weeks in the specified outcome measure and (standard error).||||<0.05
72342467|NCT01755455|144208785|SUPERIORITY_OR_OTHER|||||||0.16|||||||Fixed-effect model|||||||0.16
72342468|NCT00511134|144208792|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05||95.0|||||Descriptive data|||It was hypothesized that the Zyban+Lunesta group would report lower ISI scores at end of trial than the Zyban+Placebo group.||||<0.05
72342469|NCT00511134|144208793|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05||95.0|||||Fisher Exact|Degrees of freedom=1||It is predicted that subjects taking eszopiclone will be more likely to report abstinence at trial endpoint than those taking placebo.||||<0.05
72342470|NCT02207491|144208835|NON_INFERIORITY|Clinical noninferiority was to be concluded if the upper limit of the 95% CIs around the difference (AR-13324 - timolol) was within 1.5 mmHg at all time points and was within 1.0 mmHg at a majority of the time points.|||||<|0.0001||||||Calculated p-value|ANCOVA|Statistical analysis applies at all 3 timepoints on Day 15, Day 43, and Day 90||Assuming zero difference between AR-13324 and timolol, a 2-tailed alpha of 0.05 at each of 9 time points, a common SD of 3.0 mmHg, and a correlation between time points of 0.60 or less, 170 PP subjects per arm were necessary to have 90% power to show clinical noninferiority of AR-13324 to timolol in mean IOP.||||<0.0001
72342471|NCT02868229|144208878|SUPERIORITY||Differences of LS Means|-5.666||||0.002|TWO_SIDED|95.0|-9.082|-2.25|||ANCOVA|||The P-value was obtained from rank transformed analysis of covariance (ANCOVA) model, where the rank transformed change from baseline (CFB) values as the response variable and treatments as a factor and the rank transformed baseline value as its covariate.||-2.250|-9.082|0.002
72342472|NCT02868229|144208878|SUPERIORITY||Differences of LS Means|-6.913|||<|0.001|TWO_SIDED|95.0|-10.613|-3.214|||ANCOVA|||The P-value was obtained from rank transformed analysis of covariance (ANCOVA) model, where the rank transformed change from baseline (CFB) values as the response variable and treatments as a factor and the rank transformed baseline value as its covariate.||-3.214|-10.613|<0.001
72342473|NCT02868229|144208878|SUPERIORITY||Differences of LS Means|-9.591|||<|0.001|TWO_SIDED|95.0|-13.217|-5.965|||ANCOVA|||The P-value was obtained from rank transformed analysis of covariance (ANCOVA) model, where the rank transformed change from baseline (CFB) values as the response variable and treatments as a factor and the rank transformed baseline value as its covariate.||-5.965|-13.217|<0.001
72342474|NCT00026312|144209021|SUPERIORITY_OR_OTHER_LEGACY||Log Rank Test Statistic|2.6803||||0.1016|TWO_SIDED|95.0|||||Log Rank|||The event-free survival distributions of patients randomized to Regimen A - RA Only and randomized to Regimen B - RA + Immunotherapy were compared using the log-rank test.||||0.1016
72342475|NCT00026312|144209022|SUPERIORITY_OR_OTHER_LEGACY||Log Rank Test Statistic|2.6176||||0.1057|TWO_SIDED|95.0|||||Log Rank|||The event-free survival distributions of patients randomized to Regimen A - RA Only and randomized to Regimen B - RA + Immunotherapy for the subgroup of patients with INSS Stage 4 disease were compared using the log-rank test.||||0.1057
72342476|NCT00026312|144209025|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.0||||0.0262|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||The number of courses of therapy delivered or patients randomized to Regimen B - RA + Immunotherapy and non-randomly assigned to Regimen B after halting of randomization, excluding patients with persistent disease, were compared using the Wilcoxon rank-sum test.||||0.0262
72342477|NCT00026312|144209026|SUPERIORITY_OR_OTHER_LEGACY||Log Rank Test Statistic|3.4471||||0.0634|TWO_SIDED|95.0|||||Log Rank|||The overall survival distributions of patients randomized to Regimen A - RA Only and randomized to Regimen B - RA + Immunotherapy were compared using the log-rank test.||||0.0634
72342478|NCT00026312|144209026|SUPERIORITY_OR_OTHER_LEGACY||Log-Rank Test Statistic|4.1362||||0.042|TWO_SIDED|95.0|||||Log Rank|||The overall survival distributions of patients randomized to Regimen A - RA Only and randomized to Regimen B - RA + Immunotherapy for the subgroup of patients with INSS Stage 4 disease were compared using the log-rank test.||||0.042
72342479|NCT02250664|144209066|SUPERIORITY||Mean Difference (Net)|-5.33|STANDARD_ERROR_OF_MEAN|1.06|<|0.0001|TWO_SIDED|95.0|-7.41|-3.26||The p-value is Bonferroni-corrected for multiple comparisons with a priori threshold of significance P \< 0.0167|ANCOVA||Group difference = 0.12 mg nicotine - 0.8 mg nicotine|The statistical analysis method was ANCOVA, in order to test for statistically significant differences between group means, while controlling for covariates of interest. It was calculated that 207 subjects per group would be required to have at least 90% power to detect a mean difference of 4.52 CPD between the 0.8 mg and 0.12 mg groups at week 12, with significance level alpha of 0.0167. The significance level reflects the Bonferroni correction needed for testing of all pairwise comparisons.||-3.26|-7.41|<0.0001
72342480|NCT02250664|144209066|SUPERIORITY||Mean Difference (Net)|-7.54|STANDARD_ERROR_OF_MEAN|1.0|<|0.0001|TWO_SIDED|95.0|-9.51|-5.57||The p-value is Bonferroni-corrected for multiple comparisons with a priori threshold of significance P \< 0.0167|ANOVA|||The statistical analysis method was ANCOVA, in order to test for statistically significant differences between group means, while controlling for covariates of interest. It was calculated that 207 subjects per group would be required to have at least 90% power to detect a mean difference of 4.52 CPD between the 0.8 mg and 0.12 mg groups at week 12, with significance level alpha of 0.0167. The significance level reflects the Bonferroni correction needed for testing of all pairwise comparisons.|Group difference = 0.03 mg nicotine - 0.8 mg nicotine|-5.57|-9.51|<0.0001
72342481|NCT00117793|144209067|SUPERIORITY_OR_OTHER||||||>|0.05||95.0||||Statistical significance was set a-priori at p \< 0.05.|Mixed Models Analysis|The effect of study limb on limb volume was analyzed using repeated measures one-way analyses of variance.||||||>0.05
72342482|NCT00117793|144209068|SUPERIORITY_OR_OTHER||||||=|0.0056||95.0||||Statistical significance was set a-priori at p \< 0.05.|Mixed Models Analysis|The effect of study limb on activity level was analyzed using repeated measures one-way analyses of variance.||||||=0.0056
72342483|NCT00117793|144209069|SUPERIORITY_OR_OTHER||||||=|0.0021||95.0||||Statistical significance was set a-priori at p \< 0.05.|Mixed Models Analysis|The effect of study limb on limb pistoning was analyzed using repeated measures one-way analyses of variance.||||||=0.0021
72342484|NCT04268173|144209073|EQUIVALENCE|A two sample t-test was conducted to test the null hypothesis that the pre-intervention mean response was equivalent to the post-intervention mean response in the Prevention Navigation group. Hypothesis: A p-value greater than 0.05 suggests the means are not statistically different from one another.||||||0.84|||||||t-test, 2 sided|||||||0.84
72342485|NCT00545103|144209085|SUPERIORITY_OR_OTHER_LEGACY|||||||0.778||95.0|||||Cochran-Mantel-Haenszel|||||||0.778
72342486|NCT00545103|144209085|SUPERIORITY_OR_OTHER_LEGACY|||||||0.159||95.0|||||Cochran-Mantel-Haenszel|||||||0.159
72342487|NCT00545103|144209085|SUPERIORITY_OR_OTHER_LEGACY|||||||0.368||95.0|||||Cochran-Mantel-Haenszel|||||||0.368
72342488|NCT00545103|144209086|SUPERIORITY_OR_OTHER_LEGACY|||||||0.685||95.0|||||Cochran-Mantel-Haenszel|||||||0.685
72342489|NCT00545103|144209086|SUPERIORITY_OR_OTHER_LEGACY|||||||0.198||95.0|||||Cochran-Mantel-Haenszel|||||||0.198
72342490|NCT00545103|144209086|SUPERIORITY_OR_OTHER_LEGACY|||||||0.441||95.0|||||Cochran-Mantel-Haenszel|||||||0.441
72342491|NCT00082381|144209092|NON_INFERIORITY_OR_EQUIVALENCE|Pre-specified non-inferiority margin was 0.4% (i.e., noninferiority is demonstrated if the upper limit of a two-sided 95% confidence interval for the difference in change in HbA1c between exenatide and insulin glargine is less than 0.4%.)|Mean Difference (Final Values)|0.05||||0.4602||95.0|-0.09|0.2|||ANCOVA|||||0.20|-0.09|0.4602
72342492|NCT00082381|144209093|SUPERIORITY_OR_OTHER|||||||0.7839||95.0|||||Fisher Exact|||||||0.7839
72342493|NCT00082381|144209094|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||||||<0.0001
72342494|NCT00082381|144209095|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||||||<0.0001
72342495|NCT00082381|144209097|SUPERIORITY_OR_OTHER|||||||0.3002||95.0|||||Fisher Exact|||||||0.3002
72342496|NCT00082381|144209098|SUPERIORITY_OR_OTHER|||||||0.3385||95.0|||||ANCOVA|||||||0.3385
72342497|NCT00884832|144209134|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Proportion of semi-formed and loose stools (Bristol Form 5-7) associated with diarrhea subgroup versus no diarrhea subgroup.||||<0.001
72342498|NCT00884832|144209135|SUPERIORITY_OR_OTHER|||||||0.018||95.0|||||ANCOVA|||||||0.018
72342499|NCT00884832|144209135|SUPERIORITY_OR_OTHER|||||||0.047||95.0|||||ANCOVA|||drug\*group interactions||||0.047
72342500|NCT00884832|144209137|SUPERIORITY_OR_OTHER|||||||0.082||95.0|||||ANCOVA|||||||0.082
72342501|NCT02096263|144209138|NON_INFERIORITY|Non-inferiority in terms of immune response to pertussis antigens will be demonstrated if, for each of the three antigens, the upper limit of the 95% confidence interval (CI) on the GMC ratio \[Pediarix Group divided by Infanrix hexa Group\] is ≤ 1.5.|Adjusted GMC ratio|1.1|||||TWO_SIDED|95.0|0.92|1.31|||||Adjusted GMC (ANCOVA model adjusted with the vaccine group as fixed effect and the Infanrix vaccination history of the mother during pregnancy as continuous regressor).|To demonstrate the non-inferiority of Infanrix hexa to Pediarix co-administered with ActHIB, in terms of antibody geometric mean concentrations (GMCs) for pertussis antigen, pertussis toxoid (PT), one month after the third dose of the primary vaccination.||1.31|0.92|
72342502|NCT02096263|144209138|NON_INFERIORITY|Non-inferiority in terms of immune response to pertussis antigens will be demonstrated if, for each of the three antigens, the upper limit of the 95% confidence interval (CI) on the GMC ratio \[Pediarix Group divided by Infanrix hexa Group\] is ≤ 1.5.|Adjusted GMC ratio|1.14|||||TWO_SIDED|95.0|0.97|1.35|||||Adjusted GMC (ANCOVA model adjusted with the vaccine group as fixed effect and the Infanrix vaccination history of the mother during pregnancy as continuous regressor).|To demonstrate the non-inferiority of Infanrix hexa to Pediarix co-administered with ActHIB, in terms of antibody geometric mean concentrations (GMCs) for pertussis antigen, filamentous hemagglutinin (FHA), one month after the third dose of the primary vaccination.||1.35|0.97|
72342503|NCT02096263|144209138|NON_INFERIORITY|Non-inferiority in terms of immune response to pertussis antigens will be demonstrated if, for each of the three antigens, the upper limit of the 95% confidence interval (CI) on the GMC ratio \[Pediarix Group divided by Infanrix hexa Group\] is ≤ 1.5.|Adjusted GMC ratio|0.79|||||TWO_SIDED|95.0|0.63|0.99|||||Adjusted GMC (ANCOVA model adjusted with the vaccine group as fixed effect and the Tdap vaccination history of the mother during pregnancy as continuous regressor.).|To demonstrate the non-inferiority of Infanrix hexa to Pediarix co-administered with ActHIB, in terms of antibody geometric mean concentrations (GMCs) for pertussis antigen, pertactin (PRN), one month after the third dose of the primary vaccination.||0.99|0.63|
72342504|NCT02453555|144209181|SUPERIORITY_OR_OTHER||Adjusted Mean Difference (Net)|-1.14|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001|TWO_SIDED|95.0|-1.36|-0.91|||Mixed Models Analysis||Adjusted Mean Difference was calculated as: (adjusted mean change from baseline in HbA1c at Week 24 in Empagliflozin 10 mg/linagliptin 5 mg group) - (adjusted mean change from baseline in HbA1c at Week 24 in Linagliptin 5 mg + Placebo 10 mg group)|A restricted maximum likelihood (REML)-based mixed model repeated measures (MMRM) approach was used with baseline HbA1c as linear covariate and baseline estimated glomerular filtration rate (eGFR) (Modification of Diet in Renal Disease \[MDRD\] formula), prior use of antidiabetic drug, treatment, visit, visit by Treatment interaction as fixed effect(s). The covariance used to fit the model was unstructured.||-0.91|-1.36|<0.0001
72342505|NCT02453555|144209183|SUPERIORITY_OR_OTHER||Adjusted Mean Difference (Net)|-1.22|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-1.45|-0.99|||Mixed Models Analysis||Adjusted Mean Difference was calculated as: (adjusted mean change from baseline in HbA1c at Week 52 in All Empagliflozin group) - (adjusted mean change from baseline in HbA1c at Week 52 in All Placebo group)|A restricted maximum likelihood (REML)-based mixed model repeated measures (MMRM) approach was used with baseline HbA1c as linear covariate and baseline estimated glomerular filtration rate (eGFR) (Modification of Diet in Renal Disease \[MDRD\] formula), prior use of antidiabetic drug, treatment, visit, visit by Treatment interaction as fixed effect(s). The covariance used to fit the model was unstructured.||-0.99|-1.45|<0.0001
72342506|NCT02453555|144209184|SUPERIORITY_OR_OTHER||Adjusted Mean Difference (Net)|-1.21|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-1.45|-0.96|||Mixed Models Analysis||Adjusted Mean Difference was calculated as: (adjusted mean change from baseline in HbA1c at Week 52 in Empagliflozin 25 mg/linagliptin 5 mg group) - (adjusted mean change from baseline in HbA1c at Week 52 in Linagliptin 5 mg + Placebo 25 mg group)|A restricted maximum likelihood (REML)-based mixed model repeated measures (MMRM) approach was used with baseline HbA1c as linear covariate and baseline estimated glomerular filtration rate (eGFR) (Modification of Diet in Renal Disease \[MDRD\] formula), prior use of antidiabetic drug, treatment, visit, visit by Treatment interaction as fixed effect(s). The covariance used to fit the model was unstructured.||-0.96|-1.45|<0.0001
72342507|NCT02453555|144209185|SUPERIORITY_OR_OTHER||Adjusted Mean Difference (Net)|-1.09|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-1.34|-0.84|||Mixed Models Analysis||Adjusted Mean Difference was calculated as: (adjusted mean change from baseline in HbA1c at Week 52 in Empagliflozin 25 mg/linagliptin 5 mg group) - (adjusted mean change from baseline in HbA1c at Week 52 in All Placebo group)|A restricted maximum likelihood (REML)-based mixed model repeated measures (MMRM) approach was used with baseline HbA1c as linear covariate and baseline estimated glomerular filtration rate (eGFR) (Modification of Diet in Renal Disease \[MDRD\] formula), prior use of antidiabetic drug, treatment, visit, visit by Treatment interaction as fixed effect(s). The covariance used to fit the model was unstructured.||-0.84|-1.34|<0.0001
72342508|NCT00129961|144209186|SUPERIORITY_OR_OTHER|||||||0.022||||||Poisson regression was used to model NMSC counts using the years in study as an offset. The generalized estimated equations (GEE) approach was used to estimate parameters and compare treatment differences.|Poisson regression|Adjusted by baseline strata; Poisson model = strata + treatment.||||||0.022
72342509|NCT00129961|144209187|SUPERIORITY_OR_OTHER|||||||0.047|||||||Regression, Cox|Stratified by baseline lesions||||||0.047
72342510|NCT00129961|144209188|SUPERIORITY_OR_OTHER|||||||0.015|||||||Cochran-Mantel-Haenszel|Stratified by baseline lesion strata||||||0.015
72342511|NCT00129961|144209189|SUPERIORITY_OR_OTHER|||||||0.799||95.0|||||Chi-squared|||||||0.799
72342512|NCT00129961|144209190|SUPERIORITY_OR_OTHER|||||||0.014||95.0|||||Cochran-Mantel-Haenszel|Stratified by baseline lesion strata||SCC Well differentiated||||0.014
72342513|NCT00129961|144209190|SUPERIORITY_OR_OTHER|||||||0.491||95.0|||||Cochran-Mantel-Haenszel|Stratified by baseline lesion strata||SCC Moderately differentiated||||0.491
72342514|NCT00129961|144209190|SUPERIORITY_OR_OTHER|||||||0.905||95.0|||||Cochran-Mantel-Haenszel|Stratified by baseline lesion strata||SCC Poorly differentiated||||0.905
72342515|NCT00129961|144209190|SUPERIORITY_OR_OTHER|||||||0.018||95.0|||||Cochran-Mantel-Haenszel|Stratified by baseline lesion strata||SCC Invasive||||0.018
72342516|NCT00129961|144209190|SUPERIORITY_OR_OTHER|||||||0.012||95.0|||||Cochran-Mantel-Haenszel|Stratified by baseline lesion strata||SCC In Situ||||0.012
72342517|NCT00129961|144209190|SUPERIORITY_OR_OTHER|||||||0.463||95.0|||||Cochran-Mantel-Haenszel|Stratified by baseline lesion strata||SCC Invasive with Perineural Invasion||||0.463
72342518|NCT00129961|144209190|SUPERIORITY_OR_OTHER|||||||0.004||95.0|||||Cochran-Mantel-Haenszel|Stratified by baseline lesion strata||SCC Invasive without Perineural Invasion||||0.004
72428633|NCT00518713|144368266|SUPERIORITY_OR_OTHER|||||||0.1324||95.0|||||ANCOVA|||≥ 25% reduction. ANCOVA with the percent reduction in drop seizures as the dependent variable and treatment, pooled center, and baseline drop seizure rate as the independent variables. A step-down procedure used, starting with the high dose versus placebo.||||0.1324
72342519|NCT00129961|144209190|SUPERIORITY_OR_OTHER|||||||0.094||95.0|||||Cochran-Mantel-Haenszel|Stratified by baseline lesion strata||BCC Superficial||||0.094
72342520|NCT00129961|144209190|SUPERIORITY_OR_OTHER|||||||0.72||95.0|||||Cochran-Mantel-Haenszel|Stratified by baseline lesion strata||BCC Nodular||||0.720
72342521|NCT00129961|144209190|SUPERIORITY_OR_OTHER|||||||0.227||95.0|||||Cochran-Mantel-Haenszel|Stratified by baseline lesion strata||BCC Infiltrative||||0.227
72342522|NCT00129961|144209191|SUPERIORITY_OR_OTHER|||||||0.748||95.0|||||Poisson regression|||||||0.748
72342523|NCT00129961|144209192|SUPERIORITY_OR_OTHER|||||||0.425||95.0|||||Cochran-Mantel-Haenszel|Stratified by baseline lesion strata||||||0.425
72428634|NCT00518713|144368266|SUPERIORITY_OR_OTHER|||||||0.0026||95.0|||||ANCOVA|||≥ 25% reduction. ANCOVA with the percent reduction in drop seizures as the dependent variable and treatment, pooled center, and baseline drop seizure rate as the independent variables. A step-down procedure used, starting with the high dose versus placebo.||||0.0026
72342524|NCT00129961|144209195|SUPERIORITY_OR_OTHER|||||||0.604||95.0|||||ANCOVA|||||||0.604
72342525|NCT00129961|144209196|SUPERIORITY_OR_OTHER|||||||0.672||95.0|||||ANCOVA|||||||0.672
72342526|NCT00129961|144209197|SUPERIORITY_OR_OTHER|||||||0.999||95.0|||||Fisher Exact|||||||0.999
72342527|NCT00129961|144209198|SUPERIORITY_OR_OTHER|||||||0.588||95.0|||||Fisher Exact|||||||0.588
72342528|NCT00129961|144209199|SUPERIORITY_OR_OTHER|||||||0.999||95.0|||||Fisher Exact|||||||0.999
72342529|NCT00129961|144209200|SUPERIORITY_OR_OTHER|||||||0.03||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.030
72342530|NCT02925728|144209204|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||||||<0.0001
72342531|NCT04033068|144209205|SUPERIORITY||||||=|0.2003|||||||Fisher-Freeman-Halton Test|||||||= 0.2003
72342532|NCT04033068|144209206|SUPERIORITY||||||=|0.1448|||||||Fisher-Freeman-Halton Test|||||||= 0.1448
72342533|NCT04033068|144209207|SUPERIORITY||||||=|0.9111|||||||Fisher-Freeman-Halton Test|||||||= 0.9111
72342534|NCT04033068|144209208|SUPERIORITY||||||=|1|||||||Fisher-Freeman-Halton Test|||||||= 1.0000
72342535|NCT04033068|144209210|SUPERIORITY||GMT Ratio|0.9|||=|0.999|TWO_SIDED|95.0|0.2|5.5|||ANOVA|||Day 0||5.5|0.2|= 0.9990
72342536|NCT04033068|144209210|SUPERIORITY||GMT Ratio|0.8|||=|0.9798|TWO_SIDED|95.0|0.1|5.2|||ANOVA|||Day 0||5.2|0.1|= 0.9798
72342537|NCT04033068|144209210|SUPERIORITY||GMT Ratio|1.2|||=|0.9958|TWO_SIDED|95.0|0.1|10.1|||ANOVA|||Day 0||10.1|0.1|= 0.9958
72342538|NCT04033068|144209210|SUPERIORITY||GMT Ratio|0.8|||=|0.9935|TWO_SIDED|95.0|0.1|5.5|||ANOVA|||Day 0||5.5|0.1|= 0.9935
72342539|NCT04033068|144209210|SUPERIORITY||GMT Ratio|1.3|||=|0.9852|TWO_SIDED|95.0|0.2|10.7|||ANOVA|||Day 0||10.7|0.2|= 0.9852
72342540|NCT04033068|144209210|SUPERIORITY||GMT Ratio|1.6|||=|0.944|TWO_SIDED|95.0|0.2|14.4|||ANOVA|||Day 0||14.4|0.2|= 0.9440
72342541|NCT04033068|144209210|SUPERIORITY||GMT Ratio|1.2|||=|0.9943|TWO_SIDED|95.0|0.2|5.5|||ANOVA|||Day 28||5.5|0.2|= 0.9943
72342542|NCT04033068|144209210|SUPERIORITY||GMT Ratio|1.0|||=|0.9999|TWO_SIDED|95.0|0.2|5.1|||ANOVA|||Day 28||5.1|0.2|= 0.9999
72342543|NCT04033068|144209210|SUPERIORITY||GMT Ratio|2.2|||=|0.6476|TWO_SIDED|95.0|0.4|14.3|||ANOVA|||Day 28||14.3|0.4|= 0.6476
72342544|NCT04033068|144209210|SUPERIORITY||GMT Ratio|0.8|||=|0.9911|TWO_SIDED|95.0|0.2|4.3|||ANOVA|||Day 28||4.3|0.2|= 0.9911
72342545|NCT04033068|144209210|SUPERIORITY||GMT Ratio|1.9|||=|0.7647|TWO_SIDED|95.0|0.3|12.0|||ANOVA|||Day 28||12.0|0.3|= 0.7647
72342546|NCT04033068|144209210|SUPERIORITY||GMT Ratio|2.3|||=|0.6447|TWO_SIDED|95.0|0.3|15.8|||ANOVA|||Day 28||15.8|0.3|= 0.6447
72342547|NCT04033068|144209210|SUPERIORITY||GMT Ratio|1.3|||=|0.9638|TWO_SIDED|95.0|0.3|5.3|||ANOVA|||Day 56||5.3|0.3|= 0.9638
72342548|NCT04033068|144209210|SUPERIORITY||GMT Ratio|1.7|||=|0.7837|TWO_SIDED|95.0|0.4|7.7|||ANOVA|||Day 56||7.7|0.4|= 0.7837
72342549|NCT04033068|144209210|SUPERIORITY||GMT Ratio|2.9|||=|0.3427|TWO_SIDED|95.0|0.5|15.3|||ANOVA|||Day 56||15.3|0.5|= 0.3427
72342550|NCT04033068|144209210|SUPERIORITY||GMT Ratio|1.3|||=|0.9578|TWO_SIDED|95.0|0.3|5.8|||ANOVA|||Day 56||5.8|0.3|= 0.9578
72342551|NCT04033068|144209210|SUPERIORITY||GMT Ratio|2.2|||=|0.5637|TWO_SIDED|95.0|0.4|11.7|||ANOVA|||Day 56||11.7|0.4|= 0.5637
72342552|NCT04033068|144209210|SUPERIORITY||GMT Ratio|1.7|||=|0.8471|TWO_SIDED|95.0|0.3|9.6|||ANOVA|||Day 56||9.6|0.3|= 0.8471
72342553|NCT02986854|144209244|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Difference in percentages|30.95|||||TWO_SIDED|95.0|21.76|41.25|||Miettinen & Nurminen score method|||Serogroup A-day 29-Total seroresponse (Menveo-Menveo vs. Naive)||41.25|21.76|
72342554|NCT02986854|144209244|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Difference in percentages|30.86|||||TWO_SIDED|95.0|21.66|41.17|||Miettinen & Nurminen score method|||Serogroup A-day 29-Total seroresponse (Menactra-Menveo vs. Naive)||41.17|21.66|
72342555|NCT02986854|144209244|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Difference in percentages|30.91|||||TWO_SIDED|95.0|21.89|41.12|||Miettinen & Nurminen score method|||Serogroup A-day 29-Total seroresponse (Pooled Menveo-Menveo and Menactra-Menveo vs. Naïve)||41.12|21.89|
72342556|NCT02986854|144209244|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method.|Difference in percentages|0.09|||||TWO_SIDED|95.0|-3.15|3.36|||Miettinen & Nurminen score method|||Serogroup A- DAY 29 : Total seroresponse (Menveo-Menveo vs. Menactra-Menveo)||3.36|-3.15|
72342557|NCT02986854|144209244|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Difference in percentages|38.5|||||TWO_SIDED|95.0|28.54|48.9|||Miettinen & Nurminen score method|||Serogroup C-day 29-Total seroresponse (Menveo-Menveo vs. Naive)||48.90|28.54|
72342558|NCT02986854|144209244|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Difference in percentages|39.08|||||TWO_SIDED|95.0|29.16|49.46|||Miettinen & Nurminen score method|||Serogroup C-day 29-Total seroresponse (Menactra-Menveo vs. Naive)||49.46|29.16|
72342559|NCT02986854|144209244|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Difference in percentages|38.79|||||TWO_SIDED|95.0|29.03|49.06|||Miettinen & Nurminen score method|||Serogroup C-day 29-Total seroresponse (Pooled Menveo-Menveo and Menactra-Menveo vs. Naïve)||49.06|29.03|
72342560|NCT02986854|144209244|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Difference in percentages|-0.59|||||TWO_SIDED|95.0|-4.12|2.92|||Miettinen & Nurminen score method|||Serogroup C-DAY 29 : Total seroresponse (Menveo-Menveo vs. Menactra-Menveo)||2.92|-4.12|
72342561|NCT02986854|144209244|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Difference in percentages|59.98|||||TWO_SIDED|95.0|49.49|69.32|||Miettinen & Nurminen score method|||Serogroup W-day 29-Total seroresponse (Menveo-Menveo vs. Naive)||69.32|49.49|
72342562|NCT02986854|144209244|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Difference in percentages|57.37|||||TWO_SIDED|95.0|46.71|66.88|||Miettinen & Nurminen score method|||Serogroup W-day 29-Total seroresponse (Menactra-Menveo vs. Naive)||66.88|46.71|
72342563|NCT02986854|144209244|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Difference in percentages|58.69|||||TWO_SIDED|95.0|48.32|67.94|||Miettinen & Nurminen score method|||Serogroup W-day 29-Total seroresponse (Pooled Menveo-Menveo and Menactra-Menveo vs. Naïve)||67.94|48.32|
72342564|NCT02986854|144209244|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Difference in percentages|2.61|||||TWO_SIDED|95.0|-1.17|6.62|||Miettinen & Nurminen score method|||Serogroup W-DAY 29 : Total seroresponse (Menveo-Menveo vs. Menactra-Menveo)||6.62|-1.17|
72342565|NCT02986854|144209244|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Difference in percentages|45.25|||||TWO_SIDED|95.0|35.11|55.47|||Miettinen & Nurminen score method|||Serogroup Y-day 29-Total seroresponse (Menveo-Menveo vs. Naive)||55.47|35.11|
72342566|NCT02986854|144209244|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Difference in percentages|42.67|||||TWO_SIDED|95.0|32.34|53.04|||Miettinen & Nurminen score method|||Serogroup Y-day 29-Total seroresponse (Menactra-Menveo vs. Naive)||53.04|32.34|
72342567|NCT02986854|144209244|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Difference in percentages|43.98|||||TWO_SIDED|95.0|33.92|54.14|||Miettinen & Nurminen score method|||Serogroup Y-day 29-Total seroresponse (Pooled Menveo-Menveo and Menactra-Menveo vs. Naïve)||54.14|33.92|
72342568|NCT02986854|144209244|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Difference in percentages|2.58|||||TWO_SIDED|95.0|-0.86|6.3|||Miettinen & Nurminen score method|||Serogroup Y- DAY 29 : Total seroresponse (Menveo-Menveo vs. Menactra-Menveo)||6.3|-0.86|
72342569|NCT02986854|144209250|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|8.16|||||TWO_SIDED|95.0|1.23|13.41|||Miettinen & Nurminen score method|||Serogroup A- hSBA titer ≥8-Vaccine comparison at Day 1- (Menveo-Menveo vs. Naive)||13.41|1.23|
72342570|NCT02986854|144209250|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method.|Between group differences in percentage|10.59|||||TWO_SIDED|95.0|3.54|16.14|||Miettinen & Nurminen score method|||Serogroup A- hSBA titer ≥8-Vaccine comparison at Day 1- (Menactra-Menveo vs. Naive)||16.14|3.54|
72342571|NCT02986854|144209250|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method.|Between group differences in percentage|9.36|||||TWO_SIDED|95.0|2.72|13.58|||Miettinen & Nurminen score method|||Serogroup A- hSBA titer ≥8-Vaccine comparison at Day 1- (Pooled Menactra-Menveo vs. Naive)||13.58|2.72|
72342572|NCT02986854|144209250|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method.|Between group differences in percentage|-2.44|||||TWO_SIDED|95.0|-8.17|3.24|||Miettinen & Nurminen score method|||Serogroup A- hSBA titer ≥8-Vaccine comparison at Day 1- (Menveo-Menveo vs. Menactra-Menveo)||3.24|-8.17|
72342573|NCT02986854|144209250|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|6.94|||||TWO_SIDED|95.0|-3.57|14.15|||Miettinen & Nurminen score method|||Serogroup A- hSBA titer ≥8-Vaccine comparison at Day 4- (Menveo-Menveo vs. Naive)||14.15|-3.57|
72342574|NCT02986854|144209250|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|8.88|||||TWO_SIDED|95.0|-1.77|16.52|||Miettinen & Nurminen score method|||Serogroup A- hSBA titer ≥8-Vaccine comparison at Day 4- (Menactra-Menveo vs. Naive)||16.52|-1.77|
72342575|NCT02986854|144209250|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|7.89|||||TWO_SIDED|95.0|-2.34|13.48|||Miettinen & Nurminen score method|||Serogroup A- hSBA titer ≥8-Vaccine comparison at Day 4- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naive)||13.48|-2.34|
72342576|NCT02986854|144209250|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|-1.93|||||TWO_SIDED|95.0|-9.84|5.82|||Miettinen & Nurminen score method|||Serogroup A- hSBA titer ≥8-Vaccine comparison at Day 4- (Menveo-Menveo vs. Menactra-Menveo)||5.82|-9.84|
72342577|NCT02986854|144209250|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|44.33|||||TWO_SIDED|95.0|30.25|54.6|||Miettinen & Nurminen score method|||Serogroup A- hSBA titer ≥8-Vaccine comparison at Day 6- (Menveo-Menveo vs. Naive)||54.60|30.25|
72342578|NCT02986854|144209250|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|38.05|||||TWO_SIDED|95.0|23.93|48.58|||Miettinen & Nurminen score method|||Serogroup A- hSBA titer ≥8-Vaccine comparison at Day 6- (Menactra-Menveo vs. Naive)||48.58|23.93|
72342579|NCT02986854|144209250|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|41.26|||||TWO_SIDED|95.0|28.15|49.72|||Miettinen & Nurminen score method|||Serogroup A- hSBA titer ≥8-Vaccine comparison at Day 6- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naive)||49.72|28.15|
72342580|NCT02986854|144209250|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|6.28|||||TWO_SIDED|95.0|-5.31|17.71|||Miettinen & Nurminen score method|||Serogroup A- hSBA titer ≥8-Vaccine comparison at Day 6- (Menveo-Menveo vs. Menactra-Menveo)||17.71|-5.31|
72342581|NCT02986854|144209250|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|27.65|||||TWO_SIDED|95.0|19.25|37.65|||Miettinen & Nurminen score method|||Serogroup A- hSBA titer ≥8-Vaccine comparison at Day 29- (Menveo-Menveo vs. Naive)||37.65|19.25|
72428635|NCT00518713|144368266|SUPERIORITY_OR_OTHER|||||||0.0004||95.0|||||ANCOVA|||≥ 25% reduction. ANCOVA with the percent reduction in drop seizures as the dependent variable and treatment, pooled center, and baseline drop seizure rate as the independent variables. A step-down procedure used, starting with the high dose versus placebo.||||0.0004
72342582|NCT02986854|144209250|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|27.97|||||TWO_SIDED|95.0|19.6|37.95|||Miettinen & Nurminen score method|||Serogroup A- hSBA titer ≥8-Vaccine comparison at Day 29- (Menactra-Menveo vs. Naive)||37.95|19.60|
72342583|NCT02986854|144209250|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|27.81|||||TWO_SIDED|95.0|19.5|37.76|||Miettinen & Nurminen score method|||Serogroup A- hSBA titer ≥8-Vaccine comparison at Day 29- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naive)||37.76|19.50|
72342584|NCT02986854|144209250|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|-0.32|||||TWO_SIDED|95.0|-2.56|1.86|||Miettinen & Nurminen score method|||Serogroup A- hSBA titer ≥8-Vaccine comparison at Day 29- (Menveo-Menveo vs. Menactra-Menveo)||1.86|-2.56|
72342585|NCT02986854|144209251|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|27.78|||||TWO_SIDED|95.0|16.23|38.27|||Miettinen & Nurminen score method|||Serogroup C- hSBA titer ≥8-Vaccine comparison at Day 1- (Menveo-Menveo vs. Naive)||38.27|16.23|
72342586|NCT02986854|144209251|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|20.4|||||TWO_SIDED|95.0|8.78|31.03|||Miettinen & Nurminen score method|||Serogroup C- hSBA titer ≥8-Vaccine comparison at Day 1- (Menactra-Menveo vs. Naive)||31.03|8.78|
72342587|NCT02986854|144209251|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|24.14|||||TWO_SIDED|95.0|13.28|33.86|||Miettinen & Nurminen score method|||Serogroup C- hSBA titer ≥8-Vaccine comparison at Day 1- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naive)||33.86|13.28|
72342588|NCT02986854|144209251|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|7.37|||||TWO_SIDED|95.0|-0.76|15.42|||Miettinen & Nurminen score method|||Serogroup C- hSBA titer ≥8-Vaccine comparison at Day 1- (Menveo-Menveo vs. Menactra-Menveo)||15.42|-0.76|
72342589|NCT02986854|144209251|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|27.08|||||TWO_SIDED|95.0|11.04|42.14|||Miettinen & Nurminen score method|||Serogroup C- hSBA titer ≥8-Vaccine comparison at Day 4- (Menveo-Menveo vs. Naive)||42.14|11.04|
72342590|NCT02986854|144209251|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|16.39|||||TWO_SIDED|95.0|0.04|31.9|||Miettinen & Nurminen score method|||Serogroup C- hSBA titer ≥8-Vaccine comparison at Day 4- (Menactra-Menveo vs. Naive)||31.90|0.04|
72342591|NCT02986854|144209251|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|21.85|||||TWO_SIDED|95.0|6.73|36.11|||Miettinen & Nurminen score method|||Serogroup C- hSBA titer ≥8-Vaccine comparison at Day 4- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naive)||36.11|6.73|
72342592|NCT02986854|144209251|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|10.69|||||TWO_SIDED|95.0|-0.42|21.6|||Miettinen & Nurminen score method|||Serogroup C- hSBA titer ≥8-Vaccine comparison at Day 4- (Menveo-Menveo vs. Menactra-Menveo)||21.60|-0.42|
72342593|NCT02986854|144209251|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|44.4|||||TWO_SIDED|95.0|28.65|58.93|||Miettinen & Nurminen score method|||Serogroup C- hSBA titer ≥8-Vaccine comparison at Day 6- (Menveo-Menveo vs. Naive)||58.93|28.65|
72342594|NCT02986854|144209251|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|48.9|||||TWO_SIDED|95.0|33.45|63.13|||Miettinen & Nurminen score method|||Serogroup C- hSBA titer ≥8-Vaccine comparison at Day 6- (Menactra-Menveo vs. Naive)||63.13|33.45|
72342595|NCT02986854|144209251|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|46.61|||||TWO_SIDED|95.0|31.52|60.59|||Miettinen & Nurminen score method|||Serogroup C- hSBA titer ≥8-Vaccine comparison at Day 1- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naive)||60.59|31.52|
72342596|NCT02986854|144209251|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|-4.5|||||TWO_SIDED|95.0|-11.84|2.69|||Miettinen & Nurminen score method|||Serogroup C- hSBA titer ≥8-Vaccine comparison at Day 6- (Menveo-Menveo vs. Menactra-Menveo)||2.69|-11.84|
72342597|NCT02986854|144209251|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|12.9|||||TWO_SIDED|95.0|7.53|21.22|||Miettinen & Nurminen score method|||Serogroup C- hSBA titer ≥8-Vaccine comparison at Day 29- (Menveo-Menveo vs. Naive)||21.22|7.53|
72342598|NCT02986854|144209251|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|12.55|||||TWO_SIDED|95.0|7.1|20.89|||Miettinen & Nurminen score method|||Serogroup C- hSBA titer ≥8-Vaccine comparison at Day 29- (Menactra-Menveo vs. Naive)||20.89|7.10|
72342599|NCT02986854|144209251|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|12.73|||||TWO_SIDED|95.0|7.34|21.05|||Miettinen & Nurminen score method|||Serogroup C- hSBA titer ≥8-Vaccine comparison at Day 29- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naive)||21.05|7.34|
72342600|NCT02986854|144209251|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|0.36|||||TWO_SIDED|95.0|-0.96|1.99|||Miettinen & Nurminen score method|||Serogroup C- hSBA titer ≥8-Vaccine comparison at Day 29- (Menveo-Menveo vs. Menactra-Menveo)||1.99|-0.96|
72342601|NCT02986854|144209252|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|14.14|||||TWO_SIDED|95.0|3.46|25.39|||Miettinen & Nurminen score method|||Serogroup W- hSBA titer ≥8-Vaccine comparison at Day 1- (Menveo-Menveo vs. Naive)||25.39|3.46|
72342602|NCT02986854|144209252|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|15.66|||||TWO_SIDED|95.0|5.0|26.89|||Miettinen & Nurminen score method|||Serogroup W- hSBA titer ≥8-Vaccine comparison at Day 1- (Menactra-Menveo vs. Naive)||26.89|5.00|
72342603|NCT02986854|144209252|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|14.89|||||TWO_SIDED|95.0|4.91|25.62|||Miettinen & Nurminen score method|||Serogroup W- hSBA titer ≥8-Vaccine comparison at Day 1- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naive)||25.62|4.91|
72342604|NCT02986854|144209252|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|-1.52|||||TWO_SIDED|95.0|-8.51|5.5|||Miettinen & Nurminen score method|||Serogroup W- hSBA titer ≥8-Vaccine comparison at Day 1- (Menveo-Menveo vs. Menactra-Menveo)||5.50|-8.51|
72342605|NCT02986854|144209252|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|19.44|||||TWO_SIDED|95.0|5.25|34.83|||Miettinen & Nurminen score method|||Serogroup W- hSBA titer ≥8-Vaccine comparison at Day 4- (Menveo-Menveo vs. Naive)||34.83|5.25|
72342606|NCT02986854|144209252|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|20.11|||||TWO_SIDED|95.0|5.88|35.5|||Miettinen & Nurminen score method|||Serogroup W- hSBA titer ≥8-Vaccine comparison at Day 4- (Menactra-Menveo vs. Naive)||35.50|5.88|
72342607|NCT02986854|144209252|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|19.77|||||TWO_SIDED|95.0|6.53|34.58|||Miettinen & Nurminen score method|||Serogroup W- hSBA titer ≥8-Vaccine comparison at Day 4- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naive)||34.58|6.53|
72342608|NCT02986854|144209252|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|-0.66|||||TWO_SIDED|95.0|-9.67|8.4|||Miettinen & Nurminen score method|||Serogroup W- hSBA titer ≥8-Vaccine comparison at Day 4- (Menveo-Menveo vs. Menactra-Menveo)||8.40|-9.67|
72342609|NCT02986854|144209252|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|30.2|||||TWO_SIDED|95.0|16.78|45.45|||Miettinen & Nurminen score method|||Serogroup W- hSBA titer ≥8-Vaccine comparison at Day 6- (Menveo-Menveo vs. Naive)||45.45|16.78|
72342610|NCT02986854|144209252|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|34.22|||||TWO_SIDED|95.0|21.29|49.2|||Miettinen & Nurminen score method|||Serogroup W- hSBA titer ≥8-Vaccine comparison at Day 6- (Menactra-Menveo vs. Naive)||49.20|21.29|
72342611|NCT02986854|144209252|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|32.17|||||TWO_SIDED|95.0|19.3|47.13|||Miettinen & Nurminen score method|||Serogroup W- hSBA titer ≥8-Vaccine comparison at Day 6- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naive)||47.13|19.30|
72342612|NCT02986854|144209252|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|-4.02|||||TWO_SIDED|95.0|-9.45|0.74|||Miettinen & Nurminen score method|||Serogroup W- hSBA titer ≥8-Vaccine comparison at Day 6- (Menveo-Menveo vs. Menactra-Menveo)||0.74|-9.45|
72342613|NCT02986854|144209252|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|15.22|||||TWO_SIDED|95.0|9.28|23.95|||Miettinen & Nurminen score method|||Serogroup W- hSBA titer ≥8-Vaccine comparison at Day 29- (Menveo-Menveo vs. Naive)||23.95|9.28|
72342614|NCT02986854|144209252|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|15.22|||||TWO_SIDED|95.0|9.28|23.95|||Miettinen & Nurminen score method|||Serogroup W- hSBA titer ≥8-Vaccine comparison at Day 29- (Menactra-Menveo vs. Naive)||23.95|9.28|
72342615|NCT02986854|144209252|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|15.22|||||TWO_SIDED|95.0|9.28|23.94|||Miettinen & Nurminen score method|||Serogroup W- hSBA titer ≥8-Vaccine comparison at Day 29- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naive)||23.94|9.28|
72342616|NCT02986854|144209252|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|0.0|||||TWO_SIDED|95.0|-1.31|1.35|||Miettinen & Nurminen score method|||Serogroup W- hSBA titer ≥8-Vaccine comparison at Day 29- (Menveo-Menveo vs. Menactra-Menveo)||1.35|-1.31|
72342617|NCT02986854|144209253|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|21.75|||||TWO_SIDED|95.0|10.19|32.25|||Miettinen & Nurminen score method|||Serogroup Y- hSBA titer ≥8-Vaccine comparison at Day 1- (Menveo-Menveo vs. Naive)||32.25|10.19|
72342618|NCT02986854|144209253|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|14.72|||||TWO_SIDED|95.0|3.15|25.29|||Miettinen & Nurminen score method|||Serogroup Y- hSBA titer ≥8-Vaccine comparison at Day 1- (Menactra-Menveo vs. Naive)||25.29|3.15|
72342619|NCT02986854|144209253|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|18.27|||||TWO_SIDED|95.0|7.44|27.92|||Miettinen & Nurminen score method|||Serogroup Y- hSBA titer ≥8-Vaccine comparison at Day 1- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naive)||27.92|7.44|
72342620|NCT02986854|144209253|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|7.03|||||TWO_SIDED|95.0|-1.2|15.17|||Miettinen & Nurminen score method|||Serogroup Y- hSBA titer ≥8-Vaccine comparison at Day 1- (Menveo-Menveo vs. Menactra-Menveo)||15.17|-1.20|
72342621|NCT02986854|144209253|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|21.91|||||TWO_SIDED|95.0|5.57|36.37|||Miettinen & Nurminen score method|||Serogroup Y- hSBA titer ≥8-Vaccine comparison at Day 4- (Menveo-Menveo vs. Naive)||36.37|5.57|
72342622|NCT02986854|144209253|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|22.46|||||TWO_SIDED|95.0|6.05|37.0|||Miettinen & Nurminen score method|||Serogroup Y- hSBA titer ≥8-Vaccine comparison at Day 4- (Menactra-Menveo vs. Naive)||37.00|6.05|
72342623|NCT02986854|144209253|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|22.18|||||TWO_SIDED|95.0|6.89|35.38|||Miettinen & Nurminen score method|||Serogroup Y- hSBA titer ≥8-Vaccine comparison at Day 4- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naive)||35.38|6.89|
72342624|NCT02986854|144209253|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|-0.55|||||TWO_SIDED|95.0|-12.11|11.03|||Miettinen & Nurminen score method|||Serogroup Y- hSBA titer ≥8-Vaccine comparison at Day 4- (Menveo-Menveo vs. Menactra-Menveo)||11.03|-12.11|
72342625|NCT02986854|144209253|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|40.06|||||TWO_SIDED|95.0|24.26|54.95|||Miettinen & Nurminen score method|||Serogroup Y- hSBA titer ≥8-Vaccine comparison at Day 6- (Menveo-Menveo vs. Naive)||54.95|24.26|
72342626|NCT02986854|144209253|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|42.4|||||TWO_SIDED|95.0|26.71|57.17|||Miettinen & Nurminen score method|||Serogroup Y- hSBA titer ≥8-Vaccine comparison at Day 6- (Menactra-Menveo vs. Naive)||57.17|26.71|
72342627|NCT02986854|144209253|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|41.21|||||TWO_SIDED|95.0|26.12|55.55|||Miettinen & Nurminen score method|||Serogroup Y- hSBA titer ≥8-Vaccine comparison at Day 6- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naive)||55.55|26.12|
72342628|NCT02986854|144209253|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|-2.34|||||TWO_SIDED|95.0|-10.41|5.73|||Miettinen & Nurminen score method|||Serogroup Y- hSBA titer ≥8-Vaccine comparison at Day 6- (Menveo-Menveo vs. Menactra-Menveo)||5.73|-10.41|
72342629|NCT02986854|144209253|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|22.58|||||TWO_SIDED|95.0|15.26|32.08|||Miettinen & Nurminen score method|||Serogroup Y- hSBA titer ≥8-Vaccine comparison at Day 29- (Menveo-Menveo vs. Naive)||32.08|15.26|
72342630|NCT02986854|144209253|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|22.22|||||TWO_SIDED|95.0|14.86|31.74|||Miettinen & Nurminen score method|||Serogroup Y- hSBA titer ≥8-Vaccine comparison at Day 29- (Menactra-Menveo vs. Naive)||31.74|14.86|
72342631|NCT02986854|144209253|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|22.41|||||TWO_SIDED|95.0|15.08|31.9|||Miettinen & Nurminen score method|||Serogroup Y- hSBA titer ≥8-Vaccine comparison at Day 29- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naive)||31.90|15.08|
72342632|NCT02986854|144209253|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|0.36|||||TWO_SIDED|95.0|-0.96|1.99|||Miettinen & Nurminen score method|||Serogroup Y- hSBA titer ≥8-Vaccine comparison at Day 29- (Menveo-Menveo vs. Menactra-Menveo)||1.99|-0.96|
72342633|NCT02986854|144209254|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|7.23|||||TWO_SIDED|95.0|2.08|11.23|||Miettinen & Nurminen score method|||Serogroup A- hSBA titer ≥16-Vaccine comparison at Day 1- (Menveo-Menveo vs. Naive)||11.23|2.08|
72342634|NCT02986854|144209254|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|8.5|||||TWO_SIDED|95.0|3.28|12.74|||Miettinen & Nurminen score method|||Serogroup A- hSBA titer ≥16-Vaccine comparison at Day 1- (Menactra-Menveo vs. Naive)||12.74|3.28|
72342635|NCT02986854|144209254|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|7.86|||||TWO_SIDED|95.0|2.87|10.78|||Miettinen & Nurminen score method|||Serogroup A- hSBA titer ≥16-Vaccine comparison at Day 1- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naive)||10.78|2.87|
72342636|NCT02986854|144209254|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|-1.27|||||TWO_SIDED|95.0|-6.1|3.49|||Miettinen & Nurminen score method|||Serogroup A- hSBA titer ≥16-Vaccine comparison at Day 1- (Menveo-Menveo vs. Menactra-Menveo)||3.49|-6.10|
72342637|NCT02986854|144209254|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|6.25|||||TWO_SIDED|95.0|-3.04|12.44|||Miettinen & Nurminen score method|||Serogroup A- hSBA titer ≥16-Vaccine comparison at Day 4- (Menveo-Menveo vs. Naive)||12.44|-3.04|
72342638|NCT02986854|144209254|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|6.61|||||TWO_SIDED|95.0|-2.71|13.01|||Miettinen & Nurminen score method|||Serogroup A- hSBA titer ≥16-Vaccine comparison at Day 4- (Menactra-Menveo vs. Naive)||13.01|-2.71|
72342639|NCT02986854|144209254|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|6.43|||||TWO_SIDED|95.0|-2.66|10.9|||Miettinen & Nurminen score method|||Serogroup A- hSBA titer ≥16-Vaccine comparison at Day 4- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naive)||10.90|-2.66|
72342640|NCT02986854|144209254|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|-0.36|||||TWO_SIDED|95.0|-7.27|6.43|||Miettinen & Nurminen score method|||Serogroup A- hSBA titer ≥16-Vaccine comparison at Day 4- (Menveo-Menveo vs. Menactra-Menveo)||6.43|-7.27|
72342641|NCT02986854|144209254|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|41.34|||||TWO_SIDED|95.0|28.85|50.63|||Miettinen & Nurminen score method|||Serogroup A- hSBA titer ≥16-Vaccine comparison at Day 6- (Menveo-Menveo vs. Naive)||50.63|28.85|
72342642|NCT02986854|144209254|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|36.88|||||TWO_SIDED|95.0|24.39|46.34|||Miettinen & Nurminen score method|||Serogroup A- hSBA titer ≥16-Vaccine comparison at Day 6- (Menactra-Menveo vs. Naive)||46.34|24.39|
72342643|NCT02986854|144209254|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|39.16|||||TWO_SIDED|95.0|27.61|46.33|||Miettinen & Nurminen score method|||Serogroup A- hSBA titer ≥16-Vaccine comparison at Day 6- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naive)||46.33|27.61|
72342644|NCT02986854|144209254|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|4.46|||||TWO_SIDED|95.0|-7.04|15.83|||Miettinen & Nurminen score method|||Serogroup A- hSBA titer ≥16-Vaccine comparison at Day 6- (Menveo-Menveo vs. Menactra-Menveo)||15.83|-7.04|
72342645|NCT02986854|144209254|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|31.61|||||TWO_SIDED|95.0|22.68|41.79|||Miettinen & Nurminen score method|||Serogroup A- hSBA titer ≥16-Vaccine comparison at Day 29- (Menveo-Menveo vs. Naive)||41.79|22.68|
72342646|NCT02986854|144209254|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|30.85|||||TWO_SIDED|95.0|21.85|41.08|||Miettinen & Nurminen score method|||Serogroup A- hSBA titer ≥16-Vaccine comparison at Day 29- (Menactra-Menveo vs. Naive)||41.08|21.85|
72342647|NCT02986854|144209254|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|31.24|||||TWO_SIDED|95.0|22.39|41.38|||Miettinen & Nurminen score method|||Serogroup A- hSBA titer ≥16-Vaccine comparison at Day 29- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naive)||41.38|22.39|
72342648|NCT02986854|144209254|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|0.76|||||TWO_SIDED|95.0|-1.81|3.52|||Miettinen & Nurminen score method|||Serogroup A- hSBA titer ≥16-Vaccine comparison at Day 29- (Menveo-Menveo vs. Menactra-Menveo)||3.52|-1.81|
72342649|NCT02986854|144209255|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|30.02|||||TWO_SIDED|95.0|19.55|38.83|||Miettinen & Nurminen score method|||Serogroup C- hSBA titer ≥16-Vaccine comparison at Day 1- (Menveo-Menveo vs. Naive)||38.83|19.55|
72342650|NCT02986854|144209255|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|20.87|||||TWO_SIDED|95.0|10.48|29.69|||Miettinen & Nurminen score method|||Serogroup C- hSBA titer ≥16-Vaccine comparison at Day 1- (Menactra-Menveo vs. Naive)||29.69|10.48|
72342651|NCT02986854|144209255|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|25.5|||||TWO_SIDED|95.0|15.79|33.21|||Miettinen & Nurminen score method|||Serogroup C- hSBA titer ≥16-Vaccine comparison at Day 1- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naive)||33.21|15.79|
72342652|NCT02986854|144209255|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|9.14|||||TWO_SIDED|95.0|1.01|17.16|||Miettinen & Nurminen score method|||Serogroup C- hSBA titer ≥16-Vaccine comparison at Day 1- (Menveo-Menveo vs. Menactra-Menveo)||17.16|1.01|
72342653|NCT02986854|144209255|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|25.0|||||TWO_SIDED|95.0|8.82|38.9|||Miettinen & Nurminen score method|||Serogroup C- hSBA titer ≥16-Vaccine comparison at Day 4- (Menveo-Menveo vs. Naive)||38.90|8.82|
72342654|NCT02986854|144209255|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|15.76|||||TWO_SIDED|95.0|-0.44|29.86|||Miettinen & Nurminen score method|||Serogroup C- hSBA titer ≥16-Vaccine comparison at Day 4- (Menactra-Menveo vs. Naive)||29.86|-0.44|
72342655|NCT02986854|144209255|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|20.48|||||TWO_SIDED|95.0|5.32|33.08|||Miettinen & Nurminen score method|||Serogroup C- hSBA titer ≥16-Vaccine comparison at Day 4- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naive)||33.08|5.32|
72342656|NCT02986854|144209255|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|9.24|||||TWO_SIDED|95.0|-2.45|20.68|||Miettinen & Nurminen score method|||Serogroup C- hSBA titer ≥16-Vaccine comparison at Day 4- (Menveo-Menveo vs. Menactra-Menveo)||20.68|-2.45|
72342657|NCT02986854|144209255|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|50.25|||||TWO_SIDED|95.0|34.09|63.67|||Miettinen & Nurminen score method|||Serogroup C- hSBA titer ≥16-Vaccine comparison at Day 6- (Menveo-Menveo vs. Naive)||63.67|34.09|
72342658|NCT02986854|144209255|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|49.48|||||TWO_SIDED|95.0|33.21|63.01|||Miettinen & Nurminen score method|||Serogroup C- hSBA titer ≥16-Vaccine comparison at Day 6- (Menactra-Menveo vs. Naive)||63.01|33.21|
72342659|NCT02986854|144209255|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|49.87|||||TWO_SIDED|95.0|34.42|62.6|||Miettinen & Nurminen score method|||Serogroup C- hSBA titer ≥16-Vaccine comparison at Day 6- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naive)||62.60|34.42|
72342660|NCT02986854|144209255|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|0.77|||||TWO_SIDED|95.0|-8.3|9.92|||Miettinen & Nurminen score method|||Serogroup C- hSBA titer ≥16-Vaccine comparison at Day 6- (Menveo-Menveo vs. Menactra-Menveo)||9.92|-8.30|
72342661|NCT02986854|144209255|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|29.76|||||TWO_SIDED|95.0|21.34|39.75|||Miettinen & Nurminen score method|||Serogroup C- hSBA titer ≥16-Vaccine comparison at Day 29- (Menveo-Menveo vs. Naive)||39.75|21.34|
72342662|NCT02986854|144209255|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|29.75|||||TWO_SIDED|95.0|21.32|39.74|||Miettinen & Nurminen score method|||Serogroup C- hSBA titer ≥16-Vaccine comparison at Day 29- (Menactra-Menveo vs. Naive)||39.74|21.32|
72342663|NCT02986854|144209255|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|29.76|||||TWO_SIDED|95.0|21.35|39.73|||Miettinen & Nurminen score method|||Serogroup C- hSBA titer ≥16-Vaccine comparison at Day 29- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naive)||39.73|21.35|
72342664|NCT02986854|144209255|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|0.01|||||TWO_SIDED|95.0|-1.6|1.67|||Miettinen & Nurminen score method|||Serogroup C- hSBA titer ≥16-Vaccine comparison at Day 29- (Menveo-Menveo vs. Menactra-Menveo)||1.67|-1.60|
72342665|NCT02986854|144209256|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|17.36|||||TWO_SIDED|95.0|5.85|28.67|||Miettinen & Nurminen score method|||Serogroup W- hSBA titer ≥16-Vaccine comparison at Day 1- (Menveo-Menveo vs. Naive)||28.67|5.85|
72342666|NCT02986854|144209256|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|17.92|||||TWO_SIDED|95.0|6.39|29.25|||Miettinen & Nurminen score method|||Serogroup W- hSBA titer ≥16-Vaccine comparison at Day 1- (Menactra-Menveo vs. Naive)||29.25|6.39|
72342667|NCT02986854|144209256|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|17.64|||||TWO_SIDED|95.0|6.85|28.28|||Miettinen & Nurminen score method|||Serogroup W- hSBA titer ≥16-Vaccine comparison at Day 1- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naive)||28.28|6.85|
72342668|NCT02986854|144209256|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|-0.57|||||TWO_SIDED|95.0|-8.32|7.2|||Miettinen & Nurminen score method|||Serogroup W- hSBA titer ≥16-Vaccine comparison at Day 1- (Menveo-Menveo vs. Menactra-Menveo)||7.20|-8.32|
72342669|NCT02986854|144209256|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|14.58|||||TWO_SIDED|95.0|-0.98|30.38|||Miettinen & Nurminen score method|||Serogroup W- hSBA titer ≥16-Vaccine comparison at Day 4- (Menveo-Menveo vs. Naive)||30.38|-0.98|
72342670|NCT02986854|144209256|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|22.64|||||TWO_SIDED|95.0|7.3|38.16|||Miettinen & Nurminen score method|||Serogroup W- hSBA titer ≥16-Vaccine comparison at Day 4- (Menactra-Menveo vs. Naive)||38.16|7.30|
72342671|NCT02986854|144209256|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|18.53|||||TWO_SIDED|95.0|4.14|33.37|||Miettinen & Nurminen score method|||Serogroup W- hSBA titer ≥16-Vaccine comparison at Day 4- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naive)||33.37|4.14|
72342672|NCT02986854|144209256|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|-8.06|||||TWO_SIDED|95.0|-18.34|2.38|||Miettinen & Nurminen score method|||Serogroup W- hSBA titer ≥16-Vaccine comparison at Day 4- (Menveo-Menveo vs. Menactra-Menveo)||2.38|-18.34|
72342673|NCT02986854|144209256|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|39.04|||||TWO_SIDED|95.0|23.76|54.07|||Miettinen & Nurminen score method|||Serogroup W- hSBA titer ≥16-Vaccine comparison at Day 6- (Menveo-Menveo vs. Naive)||54.07|23.76|
72342674|NCT02986854|144209256|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|42.14|||||TWO_SIDED|95.0|27.08|56.98|||Miettinen & Nurminen score method|||Serogroup W- hSBA titer ≥16-Vaccine comparison at Day 6- (Menactra-Menveo vs. Naive)||56.98|27.08|
72342675|NCT02986854|144209256|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|40.56|||||TWO_SIDED|95.0|25.91|55.15|||Miettinen & Nurminen score method|||Serogroup W- hSBA titer ≥16-Vaccine comparison at Day 6- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naive)||55.15|25.91|
72342676|NCT02986854|144209256|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|-3.1|||||TWO_SIDED|95.0|-10.2|3.89|||Miettinen & Nurminen score method|||Serogroup W- hSBA titer ≥16-Vaccine comparison at Day 6- (Menveo-Menveo vs. Menactra-Menveo)||3.89|-10.20|
72342677|NCT02986854|144209256|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|19.57|||||TWO_SIDED|95.0|12.74|28.83|||Miettinen & Nurminen score method|||Serogroup W- hSBA titer ≥16-Vaccine comparison at Day 29- (Menveo-Menveo vs. Naive)||28.83|12.74|
72342678|NCT02986854|144209256|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|19.57|||||TWO_SIDED|95.0|12.74|28.83|||Miettinen & Nurminen score method|||Serogroup W- hSBA titer ≥16-Vaccine comparison at Day 29- (Menactra-Menveo vs. Naive)||28.83|12.74|
72342679|NCT02986854|144209256|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|19.57|||||TWO_SIDED|95.0|12.75|28.83|||Miettinen & Nurminen score method|||Serogroup W- hSBA titer ≥16-Vaccine comparison at Day 29- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naive)||28.83|12.75|
72342680|NCT02986854|144209256|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|0.0|||||TWO_SIDED|95.0|-1.31|1.35|||Miettinen & Nurminen score method|||Serogroup W- hSBA titer ≥16-Vaccine comparison at Day 29- (Menveo-Menveo vs. Menactra-Menveo)||1.35|-1.31|
72342681|NCT02986854|144209257|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|21.82|||||TWO_SIDED|95.0|11.44|30.6|||Miettinen & Nurminen score method|||Serogroup Y- hSBA titer ≥16-Vaccine comparison at Day 1- (Menveo-Menveo vs. Naive)||30.60|11.44|
72342682|NCT02986854|144209257|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|17.67|||||TWO_SIDED|95.0|7.34|26.43|||Miettinen & Nurminen score method|||Serogroup Y- hSBA titer ≥16-Vaccine comparison at Day 1- (Menactra-Menveo vs. Naive)||26.43|7.34|
72342683|NCT02986854|144209257|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|19.77|||||TWO_SIDED|95.0|10.09|27.43|||Miettinen & Nurminen score method|||Serogroup Y- hSBA titer ≥16-Vaccine comparison at Day 1- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naive)||27.43|10.09|
72342684|NCT02986854|144209257|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|4.15|||||TWO_SIDED|95.0|-3.8|12.04|||Miettinen & Nurminen score method|||Serogroup Y- hSBA titer ≥16-Vaccine comparison at Day 1- (Menveo-Menveo vs. Menactra-Menveo)||12.04|-3.80|
72342685|NCT02986854|144209257|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|18.33|||||TWO_SIDED|95.0|2.92|30.99|||Miettinen & Nurminen score method|||Serogroup Y- hSBA titer ≥16-Vaccine comparison at Day 4- (Menveo-Menveo vs. Naive)||30.99|2.92|
72342686|NCT02986854|144209257|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|18.3|||||TWO_SIDED|95.0|2.83|31.06|||Miettinen & Nurminen score method|||Serogroup Y- hSBA titer ≥16-Vaccine comparison at Day 4- (Menactra-Menveo vs. Naive)||31.06|2.83|
72342687|NCT02986854|144209257|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|18.31|||||TWO_SIDED|95.0|3.83|29.39|||Miettinen & Nurminen score method|||Serogroup Y- hSBA titer ≥16-Vaccine comparison at Day 4- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naïve)||29.39|3.83|
72342688|NCT02986854|144209257|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|0.03|||||TWO_SIDED|95.0|-11.35|11.39|||Miettinen & Nurminen score method|||Serogroup Y- hSBA titer ≥16-Vaccine comparison at Day 4- (Menveo-Menveo vs. Menactra-Menveo)||11.39|-11.35|
72342689|NCT02986854|144209257|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|48.87|||||TWO_SIDED|95.0|32.64|62.38|||Miettinen & Nurminen score method|||Serogroup Y- hSBA titer ≥16-Vaccine comparison at Day 6- (Menveo-Menveo vs. Naive)||62.38|32.64|
72342690|NCT02986854|144209257|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|48.18|||||TWO_SIDED|95.0|31.87|61.79|||Miettinen & Nurminen score method|||Serogroup Y- hSBA titer ≥16-Vaccine comparison at Day 6- (Menactra-Menveo vs. Naive)||61.79|31.87|
72342691|NCT02986854|144209257|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|48.53|||||TWO_SIDED|95.0|33.04|61.31|||Miettinen & Nurminen score method|||Serogroup Y- hSBA titer ≥16-Vaccine comparison at Day 6- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naïve)||61.31|33.04|
72342692|NCT02986854|144209257|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|0.69|||||TWO_SIDED|95.0|-8.6|10.04|||Miettinen & Nurminen score method|||Serogroup Y- hSBA titer ≥16-Vaccine comparison at Day 6- (Menveo-Menveo vs. Menactra-Menveo)||10.04|-8.60|
72342693|NCT02986854|144209257|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|35.48|||||TWO_SIDED|95.0|26.5|45.62|||Miettinen & Nurminen score method|||Serogroup Y- hSBA titer ≥16-Vaccine comparison at Day 29- (Menveo-Menveo vs. Naive)||45.62|26.50|
72342694|NCT02986854|144209257|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|34.06|||||TWO_SIDED|95.0|24.94|44.28|||Miettinen & Nurminen score method|||Serogroup Y- hSBA titer ≥16-Vaccine comparison at Day 29- (Menactra-Menveo vs. Naive)||44.28|24.94|
72342695|NCT02986854|144209257|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|34.78|||||TWO_SIDED|95.0|25.78|44.93|||Miettinen & Nurminen score method|||Serogroup Y- hSBA titer ≥16-Vaccine comparison at Day 29- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naïve)||44.93|25.78|
72342696|NCT02986854|144209257|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|1.42|||||TWO_SIDED|95.0|0.1|3.6|||Miettinen & Nurminen score method|||Serogroup Y- hSBA titer ≥16-Vaccine comparison at Day 29- (Menveo-Menveo vs. Menactra-Menveo)||3.60|0.10|
72342697|NCT02986854|144209258|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Differences in percentage|1.39|||||TWO_SIDED|95.0|-6.08|4.94|||Miettinen & Nurminen score method|||Serogroup A- Day 4- Total seroresponse (Menveo-Menveo vs. Naive)||4.94|-6.08|
72342698|NCT02986854|144209258|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Differences in percentage|2.17|||||TWO_SIDED|95.0|-5.32|6.21|||Miettinen & Nurminen score method|||Serogroup A- Day 4-Total seroresponse - (Menactra-Menveo vs. Naive)||6.21|-5.32|
72342699|NCT02986854|144209258|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Differences in percentage|1.77|||||TWO_SIDED|95.0|-5.68|4.09|||Miettinen & Nurminen score method|||Serogroup A- Day 4-Total seroresponse - (Pooled Menveo-Menveo and Menactra-Menveo vs. Naïve)||4.09|-5.68|
72342700|NCT02986854|144209258|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Differences in percentage|-0.79|||||TWO_SIDED|95.0|-4.98|3.01|||Miettinen & Nurminen score method|||Serogroup A- Day 4-Total seroresponse - (Menveo-Menveo vs. Menactra-Menveo)||3.01|-4.98|
72342701|NCT02986854|144209258|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Differences in percentage|34.76|||||TWO_SIDED|95.0|22.38|44.07|||Miettinen & Nurminen score method|||Serogroup A- Day 6-Total seroresponse- (Menveo-Menveo vs. Naive)||44.07|22.38|
72342702|NCT02986854|144209258|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Differences in percentage|26.88|||||TWO_SIDED|95.0|14.67|36.13|||Miettinen & Nurminen score method|||Serogroup A- Day 6-Total seroresponse - (Menactra-Menveo vs. Naive)||36.13|14.67|
72342703|NCT02986854|144209258|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Differences in percentage|30.89|||||TWO_SIDED|95.0|19.42|37.97|||Miettinen & Nurminen score method|||Serogroup A- Day 6-Total seroresponse - (Pooled Menveo-Menveo and Menactra-Menveo vs. Naïve)||37.97|19.42|
72342704|NCT02986854|144209258|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Differences in percentage|7.88|||||TWO_SIDED|95.0|-3.25|18.81|||Miettinen & Nurminen score method|||Serogroup A- Day 6-Total seroresponse - (Menveo-Menveo vs. Menactra-Menveo)||18.81|-3.25|
72342705|NCT02986854|144209258|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Differences in percentage|-3.45|||||TWO_SIDED|95.0|-14.26|2.35|||Miettinen & Nurminen score method|||Serogroup C- Day 4-Total seroresponse- (Menveo-Menveo vs. Naive)||2.35|-14.26|
72342706|NCT02986854|144209258|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Differences in percentage|2.51|||||TWO_SIDED|95.0|-8.7|9.98|||Miettinen & Nurminen score method|||Serogroup C- Day 4-Total seroresponse - (Menactra-Menveo vs. Naive)||9.98|-8.70|
72342707|NCT02986854|144209258|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Differences in percentage|-0.54|||||TWO_SIDED|95.0|-11.35|4.9|||Miettinen & Nurminen score method|||Serogroup C- Day 4-Total seroresponse - (Pooled Menveo-Menveo and Menactra-Menveo vs. Naïve)||4.90|-11.35|
72342708|NCT02986854|144209258|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Differences in percentage|-5.96|||||TWO_SIDED|95.0|-12.25|-0.57|||Miettinen & Nurminen score method|||Serogroup C- Day 4-Total seroresponse - (Menveo-Menveo vs. Menactra-Menveo)||-0.57|-12.25|
72342709|NCT02986854|144209258|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Differences in percentage|40.03|||||TWO_SIDED|95.0|25.37|50.92|||Miettinen & Nurminen score method|||Serogroup C- Day 6-Total seroresponse- (Menveo-Menveo vs. Naive)||50.92|25.37|
72342710|NCT02986854|144209258|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Differences in percentage|36.84|||||TWO_SIDED|95.0|22.14|47.9|||Miettinen & Nurminen score method|||Serogroup C- Day 6-Total seroresponse - (Menactra-Menveo vs. Naive)||47.90|22.14|
72342711|NCT02986854|144209258|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Differences in percentage|38.46|||||TWO_SIDED|95.0|24.79|47.57|||Miettinen & Nurminen score method|||Serogroup C- Day 6-Total seroresponse - (Pooled Menveo-Menveo and Menactra-Menveo vs. Naïve)||47.57|24.79|
72342712|NCT02986854|144209258|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Differences in percentage|3.19|||||TWO_SIDED|95.0|-8.44|14.73|||Miettinen & Nurminen score method|||Serogroup C- Day 6-Total seroresponse - (Menveo-Menveo vs. Menactra-Menveo)||14.73|-8.44|
72342713|NCT02986854|144209258|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Differences in percentage|-3.47|||||TWO_SIDED|95.0|-14.28|2.31|||Miettinen & Nurminen score method|||Serogroup W- Day 4-Total seroresponse- (Menveo-Menveo vs. Naive)||2.31|-14.28|
72342714|NCT02986854|144209258|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Differences in percentage|3.89|||||TWO_SIDED|95.0|-7.4|11.6|||Miettinen & Nurminen score method|||Serogroup W- Day 4-Total seroresponse - (Menactra-Menveo vs. Naive)||11.60|-7.40|
72342715|NCT02986854|144209258|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Differences in percentage|0.13|||||TWO_SIDED|95.0|-10.7|5.66|||Miettinen & Nurminen score method|||Serogroup W- Day 4-Total seroresponse - (Pooled Menveo-Menveo and Menactra-Menveo vs. Naïve)||5.66|-10.70|
72342716|NCT02986854|144209258|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Differences in percentage|-7.37|||||TWO_SIDED|95.0|-13.89|-1.8|||Miettinen & Nurminen score method|||Serogroup W- Day 4-Total seroresponse - (Menveo-Menveo vs. Menactra-Menveo)||-1.80|-13.89|
72342717|NCT02986854|144209258|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Differences in percentage|38.98|||||TWO_SIDED|95.0|24.35|49.88|||Miettinen & Nurminen score method|||Serogroup W- Day 6-Total seroresponse- (Menveo-Menveo vs. Naive)||49.88|24.35|
72342718|NCT02986854|144209258|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Differences in percentage|37.92|||||TWO_SIDED|95.0|23.23|48.95|||Miettinen & Nurminen score method|||Serogroup W- Day 6-Total seroresponse - (Menactra-Menveo vs. Naive)||48.95|23.23|
72342719|NCT02986854|144209258|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Differences in percentage|38.46|||||TWO_SIDED|95.0|24.8|47.56|||Miettinen & Nurminen score method|||Serogroup W- Day 6-Total seroresponse - (Pooled Menveo-Menveo and Menactra-Menveo vs. Naïve)||47.56|24.80|
72428636|NCT00518713|144368266|SUPERIORITY_OR_OTHER|||||||0.3383||95.0|||||ANCOVA|||≥ 50% reduction. ANCOVA with the percent reduction in drop seizures as the dependent variable and treatment, pooled center, and baseline drop seizure rate as the independent variables. A step-down procedure used, starting with the high dose versus placebo.||||0.3383
72428637|NCT00518713|144368266|SUPERIORITY_OR_OTHER|||||||0.0159||95.0|||||ANCOVA|||≥ 50% reduction. ANCOVA with the percent reduction in drop seizures as the dependent variable and treatment, pooled center, and baseline drop seizure rate as the independent variables. A step-down procedure used, starting with the high dose versus placebo.||||0.0159
72428638|NCT00518713|144368266|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||≥ 50% reduction. ANCOVA with the percent reduction in drop seizures as the dependent variable and treatment, pooled center, and baseline drop seizure rate as the independent variables. A step-down procedure used, starting with the high dose versus placebo.||||<0.0001
72428639|NCT00518713|144368266|SUPERIORITY_OR_OTHER|||||||0.0279||95.0|||||ANCOVA|||≥ 75% reduction. ANCOVA with the percent reduction in drop seizures as the dependent variable and treatment, pooled center, and baseline drop seizure rate as the independent variables. A step-down procedure used, starting with the high dose versus placebo.||||0.0279
72342720|NCT02986854|144209258|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Differences in percentage|1.06|||||TWO_SIDED|95.0|-10.51|12.6|||Miettinen & Nurminen score method|||Serogroup W- Day 6-Total seroresponse - (Menveo-Menveo vs. Menactra-Menveo)||12.60|-10.51|
72342721|NCT02986854|144209258|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Differences in percentage|7.75|||||TWO_SIDED|95.0|0.15|13.36|||Miettinen & Nurminen score method|||Serogroup Y- Day 4-Total seroresponse- (Menveo-Menveo vs. Naive)||13.36|0.15|
72342722|NCT02986854|144209258|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Differences in percentage|4.38|||||TWO_SIDED|95.0|-3.15|9.24|||Miettinen & Nurminen score method|||Serogroup Y- Day 4-Total seroresponse - (Menactra-Menveo vs. Naive)||9.24|-3.15|
72342723|NCT02986854|144209258|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Differences in percentage|6.09|||||TWO_SIDED|95.0|-1.41|9.55|||Miettinen & Nurminen score method|||Serogroup Y- Day 4-Total seroresponse - (Pooled Menveo-Menveo and Menactra-Menveo vs. Naïve)||9.55|-1.41|
72342724|NCT02986854|144209258|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Differences in percentage|3.37|||||TWO_SIDED|95.0|-2.48|9.54|||Miettinen & Nurminen score method|||Serogroup Y- Day 4-Total seroresponse - (Menveo-Menveo vs. Menactra-Menveo)||9.54|-2.48|
72342725|NCT02986854|144209258|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Differences in percentage|39.86|||||TWO_SIDED|95.0|25.76|50.29|||Miettinen & Nurminen score method|||Serogroup Y- Day 6-Total seroresponse- (Menveo-Menveo vs. Naive)||50.29|25.76|
72428640|NCT00518713|144368266|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||ANCOVA|||≥ 75% reduction. ANCOVA with the percent reduction in drop seizures as the dependent variable and treatment, pooled center, and baseline drop seizure rate as the independent variables. A step-down procedure used, starting with the high dose versus placebo.||||0.0010
72342726|NCT02986854|144209258|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Differences in percentage|48.05|||||TWO_SIDED|95.0|33.89|58.34|||Miettinen & Nurminen score method|||Serogroup Y- Day 6-Total seroresponse - (Menactra-Menveo vs. Naive)||58.34|33.89|
72342727|NCT02986854|144209258|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Differences in percentage|43.91|||||TWO_SIDED|95.0|30.79|52.37|||Miettinen & Nurminen score method|||Serogroup Y- Day 6-Total seroresponse - (Pooled Menveo-Menveo and Menactra-Menveo vs. Naïve)||52.37|30.79|
72428641|NCT00518713|144368266|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||≥ 75% reduction. ANCOVA with the percent reduction in drop seizures as the dependent variable and treatment, pooled center, and baseline drop seizure rate as the independent variables. A step-down procedure used, starting with the high dose versus placebo.||||<0.0001
72428642|NCT00518713|144368273|SUPERIORITY_OR_OTHER|||||||0.721||95.0|||||ANCOVA|||ANCOVA with the percent reduction in drop seizures as the dependent variable and treatment, pooled center, and baseline drop seizure rate as the independent variables. A step-down procedure used, starting with the high dose versus placebo.||||0.7210
72428643|NCT00518713|144368273|SUPERIORITY_OR_OTHER|||||||0.2505||95.0|||||ANCOVA|||ANCOVA with the percent reduction in drop seizures as the dependent variable and treatment, pooled center, and baseline drop seizure rate as the independent variables. A step-down procedure used, starting with the high dose versus placebo.||||0.2505
72428644|NCT00518713|144368273|SUPERIORITY_OR_OTHER|||||||0.0924||95.0|||||ANCOVA|||ANCOVA with the percent reduction in drop seizures as the dependent variable and treatment, pooled center, and baseline drop seizure rate as the independent variables. A step-down procedure used, starting with the high dose versus placebo.||||0.0924
72428645|NCT00518713|144368274|SUPERIORITY_OR_OTHER|||||||0.0414||95.0|||||ANCOVA|||ANCOVA with the percent reduction in drop seizures as the dependent variable and treatment, pooled center, and baseline drop seizure rate as the independent variables. A step-down procedure used, starting with the high dose versus placebo.||||0.0414
72342728|NCT02986854|144209258|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Differences in percentage|-8.19|||||TWO_SIDED|95.0|-19.61|3.45|||Miettinen & Nurminen score method|||Serogroup Y- Day 6-Total seroresponse - (Menveo-Menveo vs. Menactra-Menveo)||3.45|-19.61|
72342729|NCT02986854|144209259|OTHER|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|1.26|||||TWO_SIDED|95.0|0.93|1.7||||||Serogroup A-Vaccine comparison at day 4(Menveo-Menveo vs. Naive)||1.70|0.93|
72342730|NCT02986854|144209259|OTHER|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|1.34|||||TWO_SIDED|95.0|0.98|1.82||||||Serogroup A-Vaccine comparison at day 4(Menactra-Menveo vs. Naive)||1.82|0.98|
72342731|NCT02986854|144209259|OTHER|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|1.29|||||TWO_SIDED|95.0|0.97|1.72||||||Serogroup A-Vaccine comparison at day 4(Pooled Menveo-Menveo and Menactra-Menveo vs. Naive)||1.72|0.97|
72342732|NCT02986854|144209259|OTHER|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|0.94|||||TWO_SIDED|95.0|0.76|1.17||||||Serogroup A-Vaccine comparison at day 4 (Menveo-Menveo vs. Menactra-Menveo)||1.17|0.76|
72342733|NCT02986854|144209259|OTHER|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|5.19|||||TWO_SIDED|95.0|2.84|9.47||||||Serogroup A-Vaccine comparison at day 6 (Menveo-Menveo vs. Naive)||9.47|2.84|
72342734|NCT02986854|144209259|OTHER|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|4.1|||||TWO_SIDED|95.0|2.24|7.5||||||Serogroup A-Vaccine comparison at day 6 (Menactra-Menveo vs. Naive)||7.50|2.24|
72342735|NCT02986854|144209259|OTHER|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|4.62|||||TWO_SIDED|95.0|2.62|8.15||||||Serogroup A-Vaccine comparison at day 6 (Pooled Menveo-Menveo and Menactra-Menveo vs. Naïve)||8.15|2.62|
72342736|NCT02986854|144209259|OTHER|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|1.27|||||TWO_SIDED|95.0|0.84|1.91||||||Serogroup A-Vaccine comparison at day 6 (Menveo-Menveo vs. Menactra-Menveo)||1.91|0.84|
72342737|NCT02986854|144209259|OTHER|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|6.54|||||TWO_SIDED|95.0|4.84|8.85||||||Serogroup A-Vaccine comparison at day 29 (Menveo-Menveo vs. Naive)||8.85|4.84|
72342738|NCT02986854|144209259|OTHER|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|7.37|||||TWO_SIDED|95.0|5.44|9.98||||||Serogroup A-Vaccine comparison at day 29 (Menactra-Menveo vs. Naive)||9.98|5.44|
72342739|NCT02986854|144209259|OTHER|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|6.94|||||TWO_SIDED|95.0|5.23|9.21||||||Serogroup A-Vaccine comparison at day 29 (Pooled Menveo-Menveo and Menactra-Menveo vs. Naïve)||9.21|5.23|
72342740|NCT02986854|144209259|OTHER|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|0.89|||||TWO_SIDED|95.0|0.72|1.1||||||Serogroup A-Vaccine comparison at day 29 (Menveo-Menveo vs. Menactra-Menveo)||1.10|0.72|
72342741|NCT02986854|144209259|OTHER|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|between group GMT ratios|3.43|||||TWO_SIDED|95.0|1.95|6.04||||||Serogroup C-Vaccine comparison at day 4 (Menveo-Menveo vs. Naive)||6.04|1.95|
72342742|NCT02986854|144209259|OTHER|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|2.14|||||TWO_SIDED|95.0|1.21|3.77||||||Serogroup C-Vaccine comparison at day 4 (Menactra-Menveo vs. Naive)||3.77|1.21|
72428646|NCT00518713|144368274|SUPERIORITY_OR_OTHER|||||||0.0044||95.0|||||ANCOVA|||ANCOVA with the percent reduction in drop seizures as the dependent variable and treatment, pooled center, and baseline drop seizure rate as the independent variables. A step-down procedure used, starting with the high dose versus placebo.||||0.0044
72342743|NCT02986854|144209259|OTHER|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|2.72|||||TWO_SIDED|95.0|1.6|4.64||||||Serogroup C-Vaccine comparison at day 4 - (Pooled Menveo-Menveo and Menactra-Menveo vs. Naïve)||4.64|1.60|
72428647|NCT00518713|144368274|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||ANCOVA with the percent reduction in drop seizures as the dependent variable and treatment, pooled center, and baseline drop seizure rate as the independent variables. A step-down procedure used, starting with the high dose versus placebo.||||<0.0001
72342744|NCT02986854|144209259|OTHER|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|1.61|||||TWO_SIDED|95.0|1.07|2.4||||||Serogroup C-Vaccine comparison at day 4 (Menveo-Menveo vs. Menactra-Menveo)||2.40|1.07|
72342745|NCT02986854|144209259|OTHER|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|13.75|||||TWO_SIDED|95.0|7.51|25.19||||||Serogroup C-Vaccine comparison at day 6 (Menveo-Menveo vs. Naive)||25.19|7.51|
72342746|NCT02986854|144209259|OTHER|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|13.42|||||TWO_SIDED|95.0|7.31|24.66||||||Serogroup C-Vaccine comparison at day 6 (Menactra-Menveo vs. Naive)||24.66|7.31|
72342747|NCT02986854|144209259|OTHER|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|13.59|||||TWO_SIDED|95.0|7.7|24.0||||||Serogroup C-Vaccine comparison at day 6 (Pooled Menveo-Menveo and Menactra-Menveo vs. Naïve)||24.00|7.70|
72342748|NCT02986854|144209259|OTHER|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|1.02|||||TWO_SIDED|95.0|0.67|1.56||||||Serogroup C-Vaccine comparison at day 6 (Menveo-Menveo vs. Menactra-Menveo)||1.56|0.67|
72342749|NCT02986854|144209259|OTHER|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|19.43|||||TWO_SIDED|95.0|13.73|27.51||||||Serogroup C-Vaccine comparison at day 29 (Menveo-Menveo vs. Naive)||27.51|13.73|
72342750|NCT02986854|144209259|OTHER|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|17.72|||||TWO_SIDED|95.0|12.5|25.12||||||Serogroup C-Vaccine comparison at day 29 (Menactra-Menveo vs. Naive)||25.12|12.50|
72342751|NCT02986854|144209259|OTHER|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|18.57|||||TWO_SIDED|95.0|13.4|25.73||||||Serogroup C-Vaccine comparison at day 29 (Pooled Menveo-Menveo and Menactra-Menveo vs. Naïve)||25.73|13.40|
72342752|NCT02986854|144209259|OTHER|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|1.1|||||TWO_SIDED|95.0|0.86|1.4||||||Serogroup C-Vaccine comparison at day 29 (Menveo-Menveo vs. Menactra-Menveo)||1.40|0.86|
72342753|NCT02986854|144209259|OTHER|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|1.88|||||TWO_SIDED|95.0|1.13|3.11||||||Serogroup W-Vaccine comparison at day 4 (Menveo-Menveo vs. Naive)||3.11|1.13|
72342754|NCT02986854|144209259|OTHER|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|2.46|||||TWO_SIDED|95.0|1.48|4.08||||||Serogroup W-Vaccine comparison at day 4 (Menactra-Menveo vs. Naive)||4.08|1.48|
72342755|NCT02986854|144209259|OTHER|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|2.14|||||TWO_SIDED|95.0|1.33|3.44||||||Serogroup W-Vaccine comparison at day 4 - (Pooled Menveo-Menveo and Menactra-Menveo vs. Naïve)||3.44|1.33|
72342756|NCT02986854|144209259|OTHER|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|0.76|||||TWO_SIDED|95.0|0.53|1.1||||||Serogroup W-Vaccine comparison at day 4 (Menveo-Menveo vs. Menactra-Menveo)||1.10|0.53|
72342757|NCT02986854|144209259|OTHER|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|7.04|||||TWO_SIDED|95.0|4.05|12.22||||||Serogroup W-Vaccine comparison at day 6 (Menveo-Menveo vs. Naive)||12.22|4.05|
72342758|NCT02986854|144209259|OTHER|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|8.99|||||TWO_SIDED|95.0|5.16|15.66||||||Serogroup W-Vaccine comparison at day 6 (Menactra-Menveo vs. Naive)||15.66|5.16|
72342759|NCT02986854|144209259|OTHER|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|7.94|||||TWO_SIDED|95.0|4.72|13.35||||||Serogroup W-Vaccine comparison at day 6 (Pooled Menveo-Menveo and Menactra-Menveo vs. Naïve)||13.35|4.72|
72342760|NCT02986854|144209259|OTHER|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|0.78|||||TWO_SIDED|95.0|0.54|1.14||||||Serogroup W-Vaccine comparison at day 6 (Menveo-Menveo vs. Menactra-Menveo)||1.14|0.54|
72342761|NCT02986854|144209259|OTHER|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|25.21|||||TWO_SIDED|95.0|17.83|35.65||||||Serogroup W-Vaccine comparison at day 29 (Menveo-Menveo vs. Naive)||35.65|17.83|
72342762|NCT02986854|144209259|OTHER|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|34.06|||||TWO_SIDED|95.0|24.06|48.23||||||Serogroup W-Vaccine comparison at day 29 (Menactra-Menveo vs. Naive)||48.23|24.06|
72342763|NCT02986854|144209259|OTHER|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|29.24|||||TWO_SIDED|95.0|21.09|40.52||||||Serogroup W-Vaccine comparison at day 29 (Pooled Menveo-Menveo and Menactra-Menveo vs. Naïve)||40.52|21.09|
72342764|NCT02986854|144209259|OTHER|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|0.74|||||TWO_SIDED|95.0|0.58|0.94||||||Serogroup W-Vaccine comparison at day 29 (Menveo-Menveo vs. Menactra-Menveo)||0.94|0.58|
72342765|NCT02986854|144209259|OTHER|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|2.35|||||TWO_SIDED|95.0|1.36|4.07||||||Serogroup Y-Vaccine comparison at day 4 (Menveo-Menveo vs. Naive)||4.07|1.36|
72342766|NCT02986854|144209259|OTHER|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|2.62|||||TWO_SIDED|95.0|1.51|4.54||||||Serogroup Y-Vaccine comparison at day 4 (Menactra-Menveo vs. Naive)||4.54|1.51|
72342767|NCT02986854|144209259|OTHER|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|2.48|||||TWO_SIDED|95.0|1.48|4.14||||||Serogroup Y-Vaccine comparison at day 4 - (Pooled Menveo-Menveo and Menactra-Menveo vs. Naïve)||4.14|1.48|
72342768|NCT02986854|144209259|OTHER|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|0.9|||||TWO_SIDED|95.0|0.61|1.33||||||Serogroup Y-Vaccine comparison at day 4 (Menveo-Menveo vs. Menactra-Menveo)||1.33|0.61|
72342769|NCT02986854|144209259|OTHER|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|9.82|||||TWO_SIDED|95.0|5.47|17.64||||||Serogroup Y-Vaccine comparison at day 6 (Menveo-Menveo vs. Naive)||17.64|5.47|
72342770|NCT02986854|144209259|OTHER|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|9.55|||||TWO_SIDED|95.0|5.31|17.19||||||Serogroup Y-Vaccine comparison at day 6 (Menactra-Menveo vs. Naive)||17.19|5.31|
72342771|NCT02986854|144209259|OTHER|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|9.69|||||TWO_SIDED|95.0|5.59|16.79||||||Serogroup Y-Vaccine comparison at day 6 (Pooled Menveo-Menveo and Menactra-Menveo vs. Naïve)||16.79|5.59|
72342772|NCT02986854|144209259|OTHER|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|1.03|||||TWO_SIDED|95.0|0.69|1.54||||||Serogroup Y-Vaccine comparison at day 6 (Menveo-Menveo vs. Menactra-Menveo)||1.54|0.69|
72428648|NCT00654940|144368283|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.81|STANDARD_ERROR_OF_MEAN|0.305||||80.0|-1.21|-0.41|||ANCOVA|||Treatment comparison of pregabalin - placebo: mixed effects analysis of covariance model fitted on the full analysis set population, accounting for period and treatment effects. Subject was fitted as a random effect, and baseline was fitted as two covariates.||-0.41|-1.21|
72342773|NCT02986854|144209259|OTHER|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|28.52|||||TWO_SIDED|95.0|20.23|40.2||||||Serogroup Y-Vaccine comparison at day 29 (Menveo-Menveo vs. Naive)||40.20|20.23|
72342774|NCT02986854|144209259|OTHER|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|26.94|||||TWO_SIDED|95.0|19.09|38.02||||||Serogroup Y-Vaccine comparison at day 29 (Menactra-Menveo vs. Naive)||38.02|19.09|
72342775|NCT02986854|144209259|OTHER|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|27.73|||||TWO_SIDED|95.0|20.1|38.26||||||Serogroup Y-Vaccine comparison at day 29 (Pooled Menveo-Menveo and Menactra-Menveo vs. Naïve)||38.26|20.10|
72342776|NCT02986854|144209259|OTHER|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|1.06|||||TWO_SIDED|95.0|0.83|1.35||||||Serogroup Y-Vaccine comparison at day 29 (Menveo-Menveo vs. Menactra-Menveo)||1.35|0.83|
72342777|NCT00324233|144209264|SUPERIORITY_OR_OTHER|||||||0.56||95.0|||||equivalence testing|||||||0.56
72342778|NCT01707381|144209277|OTHER||Treatment difference|-1.773|||<|0.001|TWO_SIDED|95.0|-2.38|-1.166|||ANCOVA||Treatment Difference = BOL-303259-X 0.024% - Timolol maleate 0.5%.|||-1.166|-2.380|<0.001
72342779|NCT01707381|144209278|OTHER||Bonferroni t-test used for paired compar|0.01|||<|0.05|TWO_SIDED||||||ANOVA||the bonferroni result applies to nocturnal supine OPP data comparing BOL group to timolol group|Statistical analysis of nocturnal (supine) OPP was performed among baseline, the BOL-303259-X treatment and timolol treatment using ANOVA. the criteria for statistical significance was P\<0.05. Post hoc Bonferroni T-tests were then utilized to compare BOL and timolol groups.||||<0.05
72342780|NCT01707381|144209279|OTHER||Mean Difference (Final Values)|-1.77||||0.004|TWO_SIDED|95.0|-2.915|-0.625|||ANOVA||Treatment Difference = BOL-303259-X 0.024% - Timolol maleate 0.5%.|||-0.625|-2.915|0.004
72342781|NCT00086411|144209281|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.32|STANDARD_ERROR_OF_MEAN|0.2734|<|0.017|TWO_SIDED|95.0|0.77|2.25||The p-value was adjusted for multiple comparisons.|GEE model for repeated binary outcomes|Model included hx of heavy smoking, elevated depression, cigarettes per day, gender, and race|The above was for the main effect of BUP versus NTX on cessation.|Rates of abstinence were addressed using a generalized estimating equations (GEE) logistic regression model. Counseling type and medication type were entered as the main explanatory variables along with time and the interaction of these factors, together with some covariates (described below). The sample size provided 80% power to detect a difference of about 14% between groups across three time points (i.e., 12, 26, and 52 weeks post-treatment initiation.||2.25|0.77|<0.017
72342782|NCT02039856|144209283|SUPERIORITY|Difference-in-differences using ordered logistic regression, adjusting for age, gender, race/ethnicity, marital status, employment, education, dual use of VA and non-VA for care, diagnosis of PTSD, and the population weights, which were the product of design weights and non-response weights. We verified that proportional odds assumption was met.|Odds Ratio (OR)|0.913|STANDARD_ERROR_OF_MEAN|0.175||0.637|TWO_SIDED|95.0|0.627|1.33|||difference-in-differences analysis||The estimated value is predicted change in the odds of WH-PACT achievement, adjusting for characteristics described in the statistical analysis overview.|Change in the odds of achieving a higher WH-PACT element.||1.33|0.627|0.637
72342783|NCT02039856|144209284|SUPERIORITY|Difference-in-differences analysis using linear regression, adjusted for gender, race/ethnicity, years worked at VA, worked in women's health clinic vs general primary care clinic, clinician status vs staff status, fulltime employment, percent of women veterans enrolled at the VA facility. We adjusted our analysis using the population weights, which were the product of design weights and non-response weights.|Median Difference (Final Values)|0.33|STANDARD_ERROR_OF_MEAN|0.1195||0.006|TWO_SIDED|95.0|0.1|0.57|||Regression, Linear||The estimated value reported here is the predicted mean change over time, adjusting for characteristics described in the statistical analysis overview.|Change in gender sensitivity score between EBQI and control over time||0.57|0.10|0.006
72342784|NCT02039856|144209285|SUPERIORITY|Difference-in-differences analysis using linear regression, adjusted for gender, race/ethnicity, years worked at VA, worked in women's health clinic vs general primary care clinic, clinician status vs staff status, fulltime employment, percent of women veterans enrolled at the VA facility. We adjusted our analysis using the population weights, which were the product of design weights and non-response weights.|Mean Difference (Final Values)|0.43|STANDARD_ERROR_OF_MEAN|0.2253||0.055|TWO_SIDED|95.0|-0.01|0.87|||Regression, Linear||The estimated value reported here is the predicted mean change over time, adjusting for characteristics described in the statistical analysis overview.|Change in team functioning score between EBQI and control over time.||0.87|-0.01|0.055
72342785|NCT02039856|144209286|SUPERIORITY|We adjusted our analysis using the population weights, which were the product of design weights and non-response weights|Odds Ratio (OR)|0.36|STANDARD_ERROR_OF_MEAN|0.1922||0.058|TWO_SIDED|95.0|0.13|1.04|||Regression, Logistic||The estimated value is the predicted mean, adjusting for weights, worked in women's health vs general PC clinic, years worked at the VA, race/ethnicity, gender, full-time employment, and percent of women veterans enrolled at the VA facility.|||1.04|0.13|0.058
72342786|NCT02039856|144209287|SUPERIORITY|Difference-in-differences analysis using linear regression, adjusted for age, gender, race/ethnicity, marital status, employment, education, dual use of VA and non-VA for care, diagnosis of PTSD. We adjusted our analysis using the population weights, which were the product of design weights and non-response weights.|Median Difference (Net)|1.25|STANDARD_ERROR_OF_MEAN|0.56||0.008|TWO_SIDED|95.0|0.14|2.36|||Regression, Linear||The estimated value is predicted change in the number of VA primary care visits, adjusting for characteristics described in the statistical analysis overview.|Change in number of patient primary care visits between EBQI and control over time||2.36|0.14|0.008
72342787|NCT02039856|144209288|SUPERIORITY|Difference-in-differences analysis using linear regression, adjusted for adjusted for survey weights, age, gender, race/ethnicity, marital status, employment, education, dual use of VA and non-VA for care, diagnosis of PTSD, and the population weights, which were the product of design weights and non-response weights.|Median Difference (Net)|1.69|STANDARD_ERROR_OF_MEAN|0.413||0|TWO_SIDED|95.0|0.88|2.51|||Regression, Linear||The estimated value is predicted change in the number of VA women's health visits, adjusting for characteristics described in the statistical analysis overview.|Change in number of patient visits to women's health care between EBQI and control over time||2.51|0.88|0.000
72342788|NCT02039856|144209289|SUPERIORITY|Difference-in-differences analysis using linear regression, adjusted for adjusted for survey weights, age, gender, race/ethnicity, marital status, employment, education, dual use of VA and non-VA for care, diagnosis of PTSD. We adjusted our analysis using the population weights, which were the product of design weights and non-response weights.|Median Difference (Net)|-0.018|STANDARD_ERROR_OF_MEAN|0.068||0.794|TWO_SIDED|95.0|-0.15|0.12|||Regression, Linear||The estimated value is predicted change in the number of VA hospitalization, adjusting for characteristics described in the statistical analysis overview.|Change in number of patient hospitalization for any cause between EBQI and control over time||0.12|-0.15|0.794
72370067|NCT04173494|144250572|NON_INFERIORITY|If the lower bound of the confidence interval (CI) is greater than 0, MMB was to be declared non-inferior to DAN.|Non-inferiority difference|13.58||||0.0116|TWO_SIDED|95.0|1.86|25.3|||Cochran-Mantel-Haenszel||Non-inferiority difference, defined as p(MMB) - (0.8) \*p(DAN) where p(MMB) is percentage of participants with TI status in MMB arm and p(DAN) is percentage of participants with TI status in DAN arm.|||25.30|1.86|0.0116
72370068|NCT04173494|144250573|OTHER||Stratified Cochran-Mantel-Haenszel|33.05|||<|0.0001|TWO_SIDED|95.0|22.59|43.51|||Cochran-Mantel-Haenszel|||||43.51|22.59|< 0.0001
72342789|NCT02039856|144209290|SUPERIORITY|Difference-in-differences analysis using linear regression, adjusted for adjusted for survey weights, age, gender, race/ethnicity, marital status, employment, education, dual use of VA and non-VA for care, diagnosis of PTSD. We adjusted our analysis using the population weights, which were the product of design weights and non-response weights.|Median Difference (Net)|0.021|STANDARD_ERROR_OF_MEAN|0.15||0.888|TWO_SIDED|95.0|-0.265|0.306|||Regression, Linear||The estimated value is predicted change in the number of VA emergency room visits, adjusting for characteristics described in the statistical analysis overview.|Change in number of emergency room visits for any cause between EBQI and control over time||0.306|-0.265|0.888
72342790|NCT02409342|144209297|SUPERIORITY|Stratified analysis. OS was tested hierarchically in the efficacy analysis populations.|Hazard Ratio (HR)|0.595||||0.0106|TWO_SIDED|95.0|0.398|0.89|||Log Rank|||TC3 or IC3-WT Population||0.890|0.398|0.0106
72342791|NCT02409342|144209298|SUPERIORITY|Stratified analysis. OS was tested hierarchically in the efficacy analysis populations.|Hazard Ratio (HR)|0.868||||0.3091|TWO_SIDED|95.0|0.661|1.14|||Log Rank|||TC2/3 or IC2/3-WT Population||1.140|0.661|0.3091
72342792|NCT02409342|144209298|SUPERIORITY|Stratified analysis. OS was tested hierarchically in the efficacy analysis populations.|Hazard Ratio (HR)|0.845||||0.107|TWO_SIDED|95.0|0.688|1.037||P-value is descriptive as it was not formally tested.|Log Rank|||TC1/2/3 or IC/1/2/3-WT||1.037|0.688|0.1070
72342793|NCT02409342|144209299|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.63||||0.007|TWO_SIDED|95.0|0.449|0.884||P-value is descriptive as it was not formally tested.|Log Rank|||TC3 or IC3-WT Population||0.884|0.449|0.0070
72342794|NCT02409342|144209300|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.641||||0.0004|TWO_SIDED|95.0|0.501|0.82||P-value is descriptive as it was not formally tested.|Log Rank|||TC2/3 or IC2/3-WT Population||0.820|0.501|0.0004
72342795|NCT02409342|144209300|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.716||||0.0004|TWO_SIDED|95.0|0.595|0.863||P-value is descriptive as it was not formally tested.|Log Rank|||TC1/2/3 or IC1/2/3-WT Population||0.863|0.595|0.0004
72342796|NCT02409342|144209301|SUPERIORITY|Stratified Analysis|Difference in ORR|9.75|||||TWO_SIDED|95.0|-4.07|23.56||||||TC3 or IC3-WT Population||23.56|-4.07|
72342797|NCT02409342|144209302|SUPERIORITY|Stratified analysis|Difference in ORR|1.64|||||TWO_SIDED|95.0|-9.14|12.42||||||TC2/3 or IC2/3-WT Population||12.42|-9.14|
72342798|NCT02409342|144209302|SUPERIORITY|Stratified analysis|Difference in ORR|-0.72|||||TWO_SIDED|95.0|-8.84|7.39||||||TC1/2/3 or IC1/2/3-WT Population||7.39|-8.84|
72342799|NCT02409342|144209303|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.365|||||TWO_SIDED|95.0|0.166|0.8||||||TC3 or IC3-WT Population||0.800|0.166|
72342800|NCT02409342|144209304|SUPERIORITY|Stratified analysis|Hazard Ratio (HR)|0.235|||||TWO_SIDED|95.0|0.135|0.409||||||TC2/3 or IC2/3-WT Population||0.409|0.135|
72342801|NCT02409342|144209304|SUPERIORITY|Stratified analysis|Hazard Ratio (HR)|0.284|||||TWO_SIDED|95.0|0.19|0.424||||||TC1/2/3 or IC1/2/3-WT Population||0.424|0.190|
72342802|NCT02409342|144209305|SUPERIORITY||Difference in Event Free Rate|14.26|||||TWO_SIDED|95.0|-0.03|28.55||||||1-Year TC3 or IC3-WT Population||28.55|-0.03|
72342803|NCT02409342|144209306|SUPERIORITY||Difference in Event Free Rate|20.7|||||TWO_SIDED|95.0|2.94|38.47||||||2-Years TC3 or IC3-WT Population||38.47|2.94|
72342804|NCT02409342|144209307|SUPERIORITY||Difference in Event Free Rate|4.74|||||TWO_SIDED|95.0|-5.93|15.4||||||1-Year TC2/3 or IC2/3-WT Population||15.40|-5.93|
72342805|NCT02409342|144209307|SUPERIORITY||Difference in Event Free Rate|5.06|||||TWO_SIDED|95.0|-3.27|13.4||||||1-Year TC1/2/3 or IC1/2/3-WT Population||13.40|-3.27|
72342806|NCT02409342|144209308|SUPERIORITY||Difference in Event Free Rate|8.73|||||TWO_SIDED|95.0|-1.99|19.45||||||2-Years TC2/3 or IC2/3-WT Population||19.45|-1.99|
72342807|NCT02409342|144209308|SUPERIORITY||Difference in Event Free Rate|10.94|||||TWO_SIDED|95.0|2.83|19.04||||||2-Years TC1/2/3 or IC1/2/3-WT Population||19.04|2.83|
72342808|NCT02409342|144209309|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|1.142|||||TWO_SIDED|95.0|0.657|1.984||||||Cough in TC3 or IC3-WT Populations||1.984|0.657|
72342809|NCT02409342|144209309|SUPERIORITY|Stratified analysis|Hazard Ratio (HR)|0.891|||||TWO_SIDED|95.0|0.555|1.43||||||Dyspnoea in TC3 or IC3-WT Populations||1.430|0.555|
72342810|NCT02409342|144209309|SUPERIORITY|Stratified analysis|Hazard Ratio (HR)|1.229|||||TWO_SIDED|95.0|0.737|2.049||||||Chest pain in TC3 or IC3-WT Populations||2.049|0.737|
72342811|NCT02409342|144209311|SUPERIORITY|Stratified analysis|Hazard Ratio (HR)|0.984|||||TWO_SIDED|95.0|0.477|2.03||||||Cough for TC3 or IC3-WT Populations||2.030|0.477|
72342812|NCT02409342|144209311|SUPERIORITY|Stratified analysis|Hazard Ratio (HR)|0.955|||||TWO_SIDED|95.0|0.569|1.604||||||Dyspnea for TC3 or IC3-WT Populations||1.604|0.569|
72342813|NCT02409342|144209311|SUPERIORITY|Stratified analysis|Hazard Ratio (HR)|1.024|||||TWO_SIDED|95.0|0.472|2.222||||||Chest pain for TC3 or IC3-WT Populations||2.222|0.472|
72342814|NCT02409342|144209312|SUPERIORITY|Unstratified analysis|Hazard Ratio (HR)|0.707|||||TWO_SIDED|95.0|0.5|1.0||||||SP263 \>=50%-WT Population||1.000|0.500|
72342815|NCT02409342|144209312|SUPERIORITY|Unstratified analysis|Hazard Ratio (HR)|0.693|||||TWO_SIDED|95.0|0.502|0.956||||||SP263 \>=25%-WT Population||0.956|0.502|
72342816|NCT02409342|144209312|SUPERIORITY|Unstratified analysis|Hazard Ratio (HR)|0.768|||||TWO_SIDED|95.0|0.579|1.018||||||SP263 \>=1%-WT Population||1.018|0.579|
72342817|NCT02409342|144209313|SUPERIORITY|Unstratified analysis|Hazard Ratio (HR)|0.674|||||TWO_SIDED|95.0|0.511|0.89||||||SP263 \>=50%-WT Population||0.890|0.511|
72342818|NCT02409342|144209313|SUPERIORITY|Unstratified analysis|Hazard Ratio (HR)|0.698|||||TWO_SIDED|95.0|0.539|0.904||||||SP263 \>=25%-WT Population||0.904|0.539|
72342819|NCT02409342|144209313|SUPERIORITY|Unstratified analysis|Hazard Ratio (HR)|0.725|||||TWO_SIDED|95.0|0.577|0.91||||||SP263 \>=1%-WT Population||0.910|0.577|
72342820|NCT02409342|144209314|SUPERIORITY|Unstratified analysis|Hazard Ratio (HR)|0.867|||||TWO_SIDED|95.0|0.578|1.301||||||bTMB \>=10-WT Population||1.301|0.578|
72342821|NCT02409342|144209314|SUPERIORITY|Unstratified analysis|Hazard Ratio (HR)|0.748|||||TWO_SIDED|95.0|0.414|1.351||||||bTMB \>=16-WT Population||1.351|0.414|
72342822|NCT02409342|144209314|SUPERIORITY|Unstratified analysis|Hazard Ratio (HR)|0.77|||||TWO_SIDED|95.0|0.362|1.638||||||bTMB \>=20-WT Population||1.638|0.362|
72342823|NCT02409342|144209315|SUPERIORITY|Unstratified analysis|Hazard Ratio (HR)|0.743|||||TWO_SIDED|95.0|0.525|1.052||||||bTMB \>=10-WT Population||1.052|0.525|
72342824|NCT02409342|144209315|SUPERIORITY|Unstratified analysis|Hazard Ratio (HR)|0.553|||||TWO_SIDED|95.0|0.331|0.924||||||bTMB \>=16-WT Population||0.924|0.331|
72342825|NCT02409342|144209315|SUPERIORITY|Unstratified analysis|Hazard Ratio (HR)|0.56|||||TWO_SIDED|95.0|0.295|1.062||||||bTMB \>=20-WT Population||1.062|0.295|
72342826|NCT03464019|144209342|SUPERIORITY||Hazard Ratio (HR)|1.086||||0.1212|TWO_SIDED|95.0|0.726|1.623|||Peto-Peto test|||In Part 1, participants who converted following medical assistance were censored at the time of conversion after medical assistance. Participants who presented missing data from time t to the end were censored at the time of last available data. Participants who did not convert or were not censored before 5 hours were censored at 5 hours.||1.623|0.726|0.1212
72342827|NCT03464019|144209342|SUPERIORITY||Hazard Ratio (HR)|2.857|||<|0.001|TWO_SIDED|95.0|1.868|4.371||The threshold for statistical significance was p \< 0.05.|Wilcoxon|||In Parts 2 and 3, participants converting after additional medication interventions were censored after the end of the observation period.||4.371|1.868|<0.001
72342828|NCT01754493|144209343|SUPERIORITY_OR_OTHER_LEGACY||Slope|-18.24|||<|0.05|TWO_SIDED|95.0|-23.44|-12.63|||Mixed Models Analysis|||We used the intention-to-treat (ITT) sample, including all subjects dispensed medication (n=17). This was a repeated-measures mixed-effects regression analysis assessing the rate of change in total MADRS symptom scores for MDD. To account for the correlation of observations within individuals, we used mixed-effects models with random intercepts and a first-order autocorrelation structure. Data from each time point (wks 0, 1, 2, 3, 4, 6, 8, 12) were used in the single repeated-measures analysis.||-12.63|-23.44|<.05
72342829|NCT01754493|144209344|SUPERIORITY_OR_OTHER_LEGACY||Slope|-20.71|||<|0.05|TWO_SIDED|95.0|-27.44|-13.97|||Mixed Models Analysis|||We used the intention-to-treat (ITT) sample, including all subjects dispensed medication (n=17). This was a repeated-measures mixed-effects regression analysis assessing the rate of change in total GSRS symptom scores for IBS. To account for the correlation of observations within individuals, we used mixed-effects models with random intercepts and a first-order autocorrelation structure. Data from each time point (wks 0, 1, 2, 3, 4, 6, 8, 12) were used in the single repeated-measures analysis.||-13.97|-27.44|<0.05
72342830|NCT01754493|144209345|SUPERIORITY_OR_OTHER_LEGACY||Slope|-1.59|||<|0.05|TWO_SIDED|95.0|-2.16|-1.03|||Mixed Models Analysis|||We used the intention-to-treat (ITT) sample, including all subjects dispensed medication (n=17). This was a repeated-measures mixed-effects regression analysis assessing the rate of change in CGI-MDD score. To account for the correlation of observations within individuals, we used mixed-effects models with random intercepts and a first-order autocorrelation structure. Data from each time point (weeks 0, 1, 2, 3, 4, 6, 8, 12) were used in the single repeated-measures analysis.||-1.03|-2.16|<0.05
72342831|NCT01754493|144209345|SUPERIORITY_OR_OTHER_LEGACY||Slope|-1.55|||<|0.05|TWO_SIDED|95.0|-1.99|-1.11|||Mixed Models Analysis|||We used the intention-to-treat (ITT) sample, including all subjects dispensed medication (n=17). This was a repeated-measures mixed-effects regression analysis assessing the rate of change in CGI-IBS score. To account for the correlation of observations within individuals, we used mixed-effects models with random intercepts and a first-order autocorrelation structure. Data from each time point (weeks 0, 1, 2, 3, 4, 6, 8, 12) were used in the single repeated-measures analysis.||-1.11|-1.99|<0.05
72342832|NCT01754493|144209346|SUPERIORITY_OR_OTHER_LEGACY||Slope|-0.03|||<|0.05|TWO_SIDED|95.0|-1.16|1.1|||Mixed Models Analysis|||We used the intention-to-treat (ITT) sample, including all subjects dispensed medication (n=17). This was a repeated-measures mixed-effects regression analysis assessing the rate of change in VAS score of overall pain. To account for the correlation of observations within individuals, we used mixed-effects models with random intercepts and a first-order autocorrelation structure. Data from each time point (weeks 0, 1, 2, 3, 4, 6, 8, 12) were used in the single repeated-measures analysis.||1.10|-1.16|<0.05
72342833|NCT01754493|144209346|SUPERIORITY_OR_OTHER_LEGACY||Slope|0.47|||<|0.05|TWO_SIDED|95.0|-1.07|2.01|||Mixed Models Analysis|||We used the intention-to-treat (ITT) sample with all subjects dispensed medication (n=17). This repeated-measures mixed-effects regression analysis assessed the rate of change in VAS score of pain interfering with daily activities. To account for the correlation of observations within individuals, we used mixed-effects models with random intercepts and a 1st-order autocorrelation structure. Data from each time point (wks 0, 1, 2, 3, 4, 6, 8, 12) were used in the single repeated-measures analysis||2.01|-1.07|<0.05
72342834|NCT01754493|144209346|SUPERIORITY_OR_OTHER_LEGACY||Slope|-0.59|||<|0.05|TWO_SIDED|95.0|-2.28|1.1|||Mixed Models Analysis|||We used the intention-to-treat (ITT) sample, including all subjects dispensed medication (n=17). This was a repeated-measures mixed-effects regression analysis assessing the rate of change in VAS score of headaches. To account for the correlation of observations within individuals, we used mixed-effects models with random intercepts and a first-order autocorrelation structure. Data from each time point (weeks 0, 1, 2, 3, 4, 6, 8, 12) were used in the single repeated-measures analysis.||1.10|-2.28|<0.05
72342835|NCT01754493|144209346|SUPERIORITY_OR_OTHER_LEGACY||Slope|-0.35|||<|0.05|TWO_SIDED|95.0|-1.56|0.87|||Mixed Models Analysis|||We used the intention-to-treat (ITT) sample, including all subjects dispensed medication (n=17). This was a repeated-measures mixed-effects regression analysis assessing the rate of change in VAS score of back pain. To account for the correlation of observations within individuals, we used mixed-effects models with random intercepts and a first-order autocorrelation structure. Data from each time point (weeks 0, 1, 2, 3, 4, 6, 8, 12) were used in the single repeated-measures analysis.||.87|-1.56|<0.05
72342836|NCT01754493|144209346|SUPERIORITY_OR_OTHER_LEGACY||Slope|-0.48|||<|0.05|TWO_SIDED|95.0|-2.0|1.03|||Mixed Models Analysis|||We used the intention-to-treat (ITT) sample, including all subjects dispensed medication (n=17). This was a repeated-measures mixed-effects regression analysis assessing the rate of change in VAS score of shoulder pain. To account for the correlation of observations within individuals, we used mixed-effects models with random intercepts and a first-order autocorrelation structure. Data from each time point (weeks 0, 1, 2, 3, 4, 6, 8, 12) were used in the single repeated-measures analysis.||1.03|-2.00|<0.05
72342837|NCT01754493|144209347|SUPERIORITY_OR_OTHER_LEGACY||Slope|-4.38|||<|0.05|TWO_SIDED|95.0|-7.39|-1.36|||Mixed Models Analysis|||We used the intention-to-treat (ITT) sample with all subjects dispensed medication (n=17). This was a repeated-measures mixed-effects regression analysis assessing the rate of change in PHQ-15 scores of somatization symptoms. To account for the correlation of observations within individuals, we used mixed-effects models with random intercepts and a first-order autocorrelation structure. Data from each time point (weeks 0, 1, 2, 3, 4, 6, 8, 12) were used in the single repeated-measures analysis.||-1.36|-7.39|<0.05
72342838|NCT01543776|144209348|NON_INFERIORITY|The above criteria for non-inferiority corresponds to a response rate in the low dose arm that is no more than 15% lower than the response rate in the high dose arm (i.e., non-inferiority margin of 15%), under the assumption that the log ratios are approximately normally distributed.|Mean Difference (Final Values)|0.3976|||<|0.1|ONE_SIDED|90.0|-0.1111|||Calculated p-value.|t-test, 1 sided||||||-0.1111|<0.10
72342839|NCT01543776|144209349|SUPERIORITY|||||||0.38|||||||Log Rank|||||||0.38
72342840|NCT01543776|144209350|SUPERIORITY|||||||0.13|||||||t-test, 2 sided|||||||0.13
72342841|NCT01543776|144209351|SUPERIORITY|||||||0.26|||||||Fisher Exact|||||||0.26
72342842|NCT01543776|144209352|SUPERIORITY|||||||0.012|||||||t-test, 2 sided|||||||0.012
72342843|NCT03055013|144209359|SUPERIORITY||Cox Proportional Hazard|0.95||||0.34|TWO_SIDED|95.0|0.74|1.22|||Log Rank|stratified logrank test (one-sided)|hazard ratio : arm A vs. arm B|||1.22|0.74|0.34
72342844|NCT00528801|144209371|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.5|STANDARD_ERROR_OF_MEAN|2.07||0.008||95.0|||||Mixed Models Analysis|Adjusted for gender, age, and education.|Cases are lower than controls.|Null hypothesis is no difference between cases and controls in the WAIS-III Perormance IQ (PIQ) Index. A linear model controlling for gender, age, and education was used to compare controls versus cases using an F statistic. Based on sample-size calculations, 120 patients and 36 controls were needed to have 80% power to detect an 8-point difference on the WAIS-III PIQ Index.||||0.008
72342845|NCT00528801|144209372|SUPERIORITY_OR_OTHER||Difference in proportions|0.11||||0.048||95.0|0.026|0.199|||Fisher Exact|||Null hypothesis is no difference between cases and controls in the proportion of subjects with lacunae. This was tested using a Fisher's Exact Test.||.199|.026|0.048
72342846|NCT00344500|144209374|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||Mixed Models Analysis|Predicted trajectory of mean weight change between matched UC and LB subjects over 12 months (treatment\*time interaction: F(1,1275)=68.75, p\<.01).||General Linear Mixed Model (GLMM) used to illustrate the magnitude of difference between slopes for major outcomes for two hypothetical participants with identical baseline characteristics over 12 months.||||<0.01
72342847|NCT00126776|144209382|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||mean cumulative frequency|||primary outcome is mean cumulative frequency of COPD related hospitlaizations and ED visits ;ver 1 yr: 0.48 for disease management; 0.82 for usual care, difference 0.34 (95% CI 0.15 to 0.52; P\<0.001)||||< 0.001
72342848|NCT00599755|144209383|SUPERIORITY_OR_OTHER||Proportion|0.4|||||TWO_SIDED|80.0|0.27|0.55||||||||0.55|0.27|
72342849|NCT00599755|144209384|SUPERIORITY_OR_OTHER||Concordance correlation coefficient|0.88|||||TWO_SIDED|80.0|0.85|0.92||||||||0.92|0.85|
72342850|NCT00599755|144209388|SUPERIORITY_OR_OTHER||Proportion|0.125|||||TWO_SIDED|80.0|0.06|0.23||||||||0.23|0.06|
72342851|NCT02893917|144209389|SUPERIORITY||Hazard Ratio (HR)|0.617||||0.0359|TWO_SIDED|95.0|0.392|0.969|||Regression, Cox|||||0.969|0.392|0.0359
72342852|NCT02893917|144209390|SUPERIORITY||Hazard Ratio (HR)|1.3|||||TWO_SIDED|95.0|0.705|2.399||no p value provided|Regression, Cox|||||2.399|0.705|
72342853|NCT02893917|144209393|OTHER||Hazard Ratio (HR)|0.65|||||TWO_SIDED|95.0|0.272|1.504|||Regression, Cox|||HRD positive ONLY||1.504|0.272|
72342854|NCT02893917|144209393|OTHER||Hazard Ratio (HR)|0.777|||||TWO_SIDED|95.0|0.448|1.348|||Regression, Cox|||HRD negative ONLY||1.348|0.448|
72342855|NCT00568126|144209402|SUPERIORITY|Remission rates for maca vs. placebo were compared by chi-squared and by odds ratio (with 95% confidence interval).|Odds Ratio (OR)|2.1||||0.55|TWO_SIDED|95.0|0.18|25.2||P values above are calculated. No multiple comparisons. Threshold for significance set a priori as P\<0.05.|Chi-squared||Odds ratio for attaining remission while taking maca vs taking placebo|"Treatment groups were compared based on percentage reaching remission thresholds per scale: a total score of 12 (minimally diminished) or less on the MGH-SFQ scale, and a total score of 10 (very strong/very easily/very satisfying) or less on the ASEX."||25.2|0.18|0.55
72342856|NCT00568126|144209403|SUPERIORITY|Remission rates for maca vs. placebo were compared by chi-squared and by odds ratio (with 95% confidence interval).|Odds Ratio (OR)|1.71||||0.47|TWO_SIDED|95.0|0.4|7.34||P values above are calculated. No multiple comparisons. Threshold for significance set a priori as P\<0.05.|Chi-squared||Odds ratio for attaining remission while taking maca vs taking placebo|"Treatment groups were compared based on percentage reaching remission thresholds per scale: a total score of 12 (minimally diminished) or less on the MGH-SFQ scale, and a total score of 10 (very strong/very easily/very satisfying) or less on the ASEX."||7.34|0.40|0.47
72342857|NCT01939366|144209404|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|0.37||0.0621|TWO_SIDED|95.0|-1.43|0.04||Due to the exploratory character of this trial, no multiple testing adjustment for control of the false positive rate was applied.|Mixed Models Analysis|The analysis consisted of the contrasts (mixed model Wald tests) of individual cebranopadol doses versus placebo during Week 6 of Maintenance Phase.||The mixed model repeated measurement (MMRM) model included fixed effects of pooled sites, treatment, week, treatment-by-week interaction, baseline pain, and a subject-specific random effect. The model was based on the weekly average 24-hour pain intensity of the 2 weeks in the Titration Phase and 6 weeks in the Maintenance Phase. An unstructured covariance matrix was used to model the covariance structure, denominator degrees of freedom were estimated using the Kenward-Roger approximation.||0.04|-1.43|0.0621
72342858|NCT01939366|144209404|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.74|STANDARD_ERROR_OF_MEAN|0.39||0.0564|TWO_SIDED|95.0|-1.5|0.02||Due to the exploratory character of this trial, no multiple testing adjustment for control of the false positive rate was applied.|Mixed Models Analysis|The analysis consisted of the contrasts (mixed model Wald tests) of individual cebranopadol doses versus placebo during Week 6 of Maintenance Phase.||The mixed model repeated measurement (MMRM) model included fixed effects of pooled sites, treatment, week, treatment-by-week interaction, baseline pain, and a subject-specific random effect. The model was based on the weekly average 24-hour pain intensity of the 2 weeks in the Titration Phase and 6 weeks in the Maintenance Phase. An unstructured covariance matrix was used to model the covariance structure, denominator degrees of freedom were estimated using the Kenward-Roger approximation.||0.02|-1.50|0.0564
72342859|NCT01939366|144209404|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.01|STANDARD_ERROR_OF_MEAN|0.41||0.0153|TWO_SIDED|95.0|-1.83|-0.2||Due to the exploratory character of this trial, no multiple testing adjustment for control of the false positive rate was applied.|Mixed Models Analysis|The analysis consisted of the contrasts (mixed model Wald tests) of individual cebranopadol doses versus placebo during Week 6 of Maintenance Phase.||The mixed model repeated measurement (MMRM) model included fixed effects of pooled sites, treatment, week, treatment-by-week interaction, baseline pain, and a subject-specific random effect. The model was based on the weekly average 24-hour pain intensity of the 2 weeks in the Titration Phase and 6 weeks in the Maintenance Phase. An unstructured covariance matrix was used to model the covariance structure, denominator degrees of freedom were estimated using the Kenward-Roger approximation.||-0.20|-1.83|0.0153
72342860|NCT00680797|144209405|SUPERIORITY_OR_OTHER|||||||0.023|TWO_SIDED|||||Comparison of pre- to post-intervention insulin levels between the groups receiving E only versus the group receiving no hormone replacement.|ANCOVA|||The major outcome variable being presented is changes in insulin levels. Changes in insulin levels were analyzed using an ANCOVA model that adjusted for baseline insulin and age.||||0.023
72342861|NCT00680797|144209405|SUPERIORITY_OR_OTHER|||||||0.042|TWO_SIDED|||||Comparison in the change in insulin levels between the groups receiving E with or without T.|ANCOVA|||The major outcome variable being presented is changes in insulin levels. Changes in insulin levels were analyzed using an ANCOVA model that adjusted for baseline insulin and age.||||0.042
72342862|NCT02596230|144209452|OTHER||Hazard Ratio (HR)|0.634||||0.188|TWO_SIDED|95.0|0.322|1.249||One-side p-value|Regression, Cox|Cox-regression proportional hazards model including fixed effects for treatment.|Hazard Ratio \< 1 favors Dabigatran etexilate.|||1.249|0.322|0.188
72342863|NCT02596230|144209453|OTHER||Hazard Ratio (HR)|0.778||||0.606|TWO_SIDED|95.0|0.3|2.017||One-side p-value|Regression, Cox|Cox-regression proportional hazards model including fixed effects for treatment.|Hazard Ratio \< 1 favors Dabigatran etexilate.|||2.017|0.300|0.606
72342864|NCT02596230|144209454|OTHER||Hazard Ratio (HR)|0.751||||0.542|TWO_SIDED|95.0|0.299|1.885||One-side p-value|Regression, Cox|Cox-regression proportional hazards model including fixed effects for treatment.|Hazard Ratio \< 1 favors Dabigatran etexilate.|||1.885|0.299|0.542
72342865|NCT02596230|144209455|OTHER||Hazard Ratio (HR)|0.0||||0.996|TWO_SIDED|95.0||||One-side p-value|Regression, Cox|Cox-regression proportional hazards model including fixed effects for treatment.|"Hazard Ratio \< 1 favors Dabigatran etexilate.~Hazard Ratio is actually \<0.01~95% Confidence Interval is not calculable (NA) due to insufficient number of participants with events."|||||0.996
72342866|NCT02596230|144209456|OTHER||Hazard Ratio (HR)|0.857||||0.69|TWO_SIDED|95.0|0.402|1.828||One-side p-value|Regression, Cox|Cox-regression proportional hazards model including fixed effects for treatment.|Hazard Ratio \< 1 favors Dabigatran etexilate.|||1.828|0.402|0.690
72342867|NCT00151476|144209478|SUPERIORITY_OR_OTHER_LEGACY||Kaplan-Meier Estimate of Time to Event|14.49||||||95.0|3.48|301.64|||||Kaplan-Meier Estimate of Time to Event (months).|"Time to FAP-related surgical events (months); twenty-fifth (25th) percentile presented due to limited number of subjects.~Index date based on most recent colon and or rectum adenomatous polyps evaluation, most recent duodenal adenomatous polyps evaluation, and most recent desmoids tumors evaluation for Matched Control, Not Matched Celecoxib, and All Celecoxib Treated, respectively.~Only 13 matched pairs identified: p-values not computed in analysis of time-to-event endpoints"||301.64|3.48|
72342868|NCT00151476|144209478|SUPERIORITY_OR_OTHER_LEGACY||Kaplan-Meier Estimate of Time to Event|5.06||||||95.0|3.48|11.76|||||Kaplan-Meier Estimate of Time to Event (months).|Time to FAP-related surgical events (months); 25th percentile.||11.76|3.48|
72342869|NCT00151476|144209478|SUPERIORITY_OR_OTHER_LEGACY||Kaplan-Meier Estimate of Time to Event|5.52||||||95.0|3.48|14.49|||||Kaplan-Meier Estimate of Time to Event (months).|Time to FAP-related surgical events (months); 25th percentile.||14.49|3.48|
72342870|NCT00151476|144209479|SUPERIORITY_OR_OTHER_LEGACY||Kaplan-Meier Estimate of Time to Event|5.98||||||95.0|0.0|33.77|||||Kaplan-Meier Estimate of Time to Event (months).|Time to FAP-related surgical events (months); 25th percentile.||33.77|0.00|
72342871|NCT00151476|144209479|SUPERIORITY_OR_OTHER_LEGACY||Kaplan-Meier Estimate of Time to Event|19.81||||||95.0|0.0|33.77|||||Kaplan-Meier Estimate of Time to Event (months).|Time to FAP-related surgical events (months); 25th percentile.||33.77|0.00|
72342872|NCT00151476|144209480|SUPERIORITY_OR_OTHER_LEGACY||Kaplan-Meier Estimate of Time to Event|137.34||||||95.0|104.73|183.48|||||Kaplan-Meier Estimate of Time to Event (months).|Time to FAP-related surgical events (months); 25th percentile. Index date based on most recent colon and or rectum adenomatous polyps evaluation, most recent duodenal adenomatous polyps evaluation, and most recent desmoids tumors evaluation for Matched Control, Not Matched Celecoxib, and All Celecoxib Treated, respectively.||183.48|104.73|
72342873|NCT00151476|144209480|SUPERIORITY_OR_OTHER_LEGACY||Kaplan-Meier Estimate of Time to Event|169.94||||||95.0|104.73|183.48|||||Kaplan-Meier Estimate of Time to Event (months).|Time to FAP-related surgical events (months); 25th percentile.||183.48|104.73|
72342874|NCT00151476|144209481|SUPERIORITY_OR_OTHER_LEGACY||Kaplan-Meier Estimate of Time to Event|11.28||||||95.0|9.07|38.24|||||Kaplan-Meier Estimate of Time to Event (months).|Time to FAP-related surgical events (months); 25th percentile.||38.24|9.07|
72342875|NCT00151476|144209482|SUPERIORITY_OR_OTHER_LEGACY||Kaplan-Meier Estimate of Time to Event|20.63||||||95.0|8.05|48.03|||||Kaplan-Meier Estimate of Time to Event (months).|Time to FAP-related surgical events (months); 25th percentile.||48.03|8.05|
72342876|NCT00151476|144209482|SUPERIORITY_OR_OTHER_LEGACY||Kaplan-Meier Estimate of Time to Event|40.21||||||95.0|8.31|105.68|||||Kaplan-Meier Estimate of Time to Event (months).|Time to FAP-related surgical events (months); 25th percentile.||105.68|8.31|
72342877|NCT00151476|144209482|SUPERIORITY_OR_OTHER_LEGACY||Kaplan-Meier Estimate of Time to Event|19.81||||||95.0|16.03|56.34|||||Kaplan-Meier Estimate of Time to Event (months).|Time to FAP-related surgical events (months); 25th percentile.||56.34|16.03|
72342878|NCT00151476|144209482|SUPERIORITY_OR_OTHER_LEGACY||Kaplan-Meier Estimate of Time to Event|20.22||||||95.0|12.35|40.31|||||Kaplan-Meier Estimate of Time to Event (months).|Time to FAP-related surgical events (months); 25th percentile.||40.31|12.35|
72342879|NCT00151476|144209484|SUPERIORITY_OR_OTHER_LEGACY||Kaplan-Meier Estimate of Time to Event|21.22||||||95.0|4.07|64.16|||||Kaplan-Meier Estimate of Time to Event (months).|Time to FAP-related events (months); 25th percentile.||64.16|4.07|
72342880|NCT00151476|144209484|SUPERIORITY_OR_OTHER_LEGACY||Kaplan-Meier Estimate of Time to Event|19.81||||||95.0|3.68|64.16|||||Kaplan-Meier Estimate of Time to Event (months).|Time to FAP-related events (months); 25th percentile.||64.16|3.68|
72342881|NCT03446456|144209491|EQUIVALENCE|An equivalence test was conducted to compare if the vasopressin group differed from the saline group in changes of BOLD signal in the brain.|Mean Difference (Final Values)|0.00264||||0.982|TWO_SIDED|||||Bonferroni corrected|t-test, 2 sided|||Percentage of BOLD signal change was calculated as the BOLD signal in the right supplementary motor area (SMA, a typical brain area responding to pain stimulation), divided by the BOLD signal of the whole-brain average during the 24 trials of 20-second painful stimulations. The percentage of BOLD signal changes in SMA during the 20-second painful stimulations were compared between the Saline group and the Vasopressin group using an equivalence test.||||0.982
72370069|NCT04173494|144250574|OTHER||Least Squares Mean Difference|-6.22||||0.0014|TWO_SIDED|95.0|-10.0|-2.43|||mixed model for repeated measures (MMRM)|||||-2.43|-10.0|0.0014
72342882|NCT03446456|144209492|EQUIVALENCE|An equivalence test was conducted to compare if the vasopressin group differed from the saline group in heating temperature that was used for the testing phase.|Mean Difference (Final Values)|-0.282||||0.269|TWO_SIDED|||||Bonferroni corrected|ANCOVA|The drug group (Vasopressin vs. Saline) was set as a between-subject factor. Age and race were treated as covariates.||||||0.269
72342883|NCT03446456|144209493|EQUIVALENCE|An equivalence test was conducted to compare if the vasopressin group differed from the saline group in implicit racial biases.|Mean Difference (Final Values)|-0.04||||0.378|TWO_SIDED||||||ANCOVA|Drug group (Vasopressin vs. Saline) was set as between-subject factor. Age and race were treated as covariates.||"Response latencies were recorded to calculate the IAT difference score (D). A difference score (D) was calculated based on the following steps: 1) Compute the standard deviation (SD) of response latencies from overall trials; 2) M1 is the mean of the response latencies in the condition where White people and good share the same response key. M2 is the mean of the latencies in the condition where African-American/Asian people and good share the same response key; 3) D = (M2-M1)/SD."||||0.378
72342884|NCT03446456|144209494|EQUIVALENCE|An equivalence test was conducted to compare if the vasopressin group differed from the saline group in self-reported pain intensity ratings.|Mean Difference (Final Values)|-2.35||||0.014|TWO_SIDED|||||Bonferroni corrected|Mixed Models Analysis|Age, race, and heating temperature used during the testing phase were treated as covariates.||||||0.014
72342885|NCT04099511|144209516|SUPERIORITY|||||||0.693|||||||Wilcoxon (Mann-Whitney)|||||||.693
72342886|NCT04099511|144209517|SUPERIORITY|||||||0.536|||||||Wilcoxon (Mann-Whitney)|||||||.536
72342887|NCT04099511|144209518|SUPERIORITY|||||||0.26|||||||Wilcoxon (Mann-Whitney)|||||||.260
72342888|NCT04099511|144209519|SUPERIORITY|||||||0.387|||||||Wilcoxon (Mann-Whitney)|||||||.387
72342889|NCT04099511|144209520|SUPERIORITY|||||||0.826|||||||Wilcoxon (Mann-Whitney)|||||||0.826
72342890|NCT04099511|144209521|SUPERIORITY|||||||0.826|||||||Wilcoxon (Mann-Whitney)|||||||0.826
72342891|NCT04099511|144209522|SUPERIORITY|||||||0.388|||||||Wilcoxon (Mann-Whitney)|||||||0.388
72342892|NCT04099511|144209523|SUPERIORITY|||||||0.308|||||||Wilcoxon (Mann-Whitney)|||||||0.308
72342893|NCT03002311|144209545|SUPERIORITY|We conducted a conditional power analysis 120 days after 6 months of enrollment. We determined the effect size based on the difference of proportions of follow-up attendance in the intervention and control arms. We used the effect size of 20% to estimate the sample size needed for a two-sided alpha of 0.05 at 90% power and a 1:1 ratio to require 266 participants. Loss to follow-up was estimated to be 20%, increasing target enrollment to 334 total participants.|||||<|0.001|||||||Gray's test|We compared the cumulative incidence function.||||||<0.001
72342894|NCT03002311|144209546|SUPERIORITY|This was a secondary analysis so no power analysis was done.||||||0.8||||||We used a two-sided alpha of 0.05 to determine significance.|Gray's test|We compared the cumulative incidence functions.||||||0.8
72342895|NCT03270891|144209569|SUPERIORITY|Null hypothesis of equality.||||||0.0115|||||||t-test, 2 sided|||Baseline and 6 month values||||0.0115
72342896|NCT03270891|144209569|SUPERIORITY|Null hypothesis of equality.||||||0.027|||||||t-test, 2 sided|||baseline to 6 month comparison||||0.027
72342897|NCT03270891|144209570|SUPERIORITY|Null hypothesis of equality.||||||0.0327|||||||t-test, 2 sided|||Baseline p value to six month||||0.0327
72342898|NCT03270891|144209570|SUPERIORITY|Null hypothesis of equality.||||||0.2088|||||||t-test, 2 sided|||baseline to 6 month comparison p value||||0.2088
72342899|NCT03270891|144209571|SUPERIORITY|Null hypothesis of equality.||||||0.947|||||||t-test, 2 sided|||baseline to 6 month comparison||||0.947
72342900|NCT02883062|144209581|SUPERIORITY|||||||0.36|||||||Generalized estimating equation (GEE)|||||||0.36
72342901|NCT02883062|144209582|SUPERIORITY|||||||0.018|||||||Regression, Logistic|||||||0.018
72342902|NCT02888743|144209590|SUPERIORITY||Difference between proportions|0.0||||0.99|TWO_SIDED|90.0|-14.6|14.6|||Chi-squared||Arm A compared with Arm C; normal approximation for confidence interval|||14.6|-14.6|0.99
72342903|NCT02888743|144209590|SUPERIORITY||Difference between proportions|-3.8||||0.64|TWO_SIDED|90.0|-17.3|9.6|||Chi-squared||Arm B compared with Arm C; normal approximation used for confidence interval.|||9.6|-17.3|0.64
72342904|NCT02888743|144209591|SUPERIORITY||Hazard Ratio (HR)|0.81||||0.92|TWO_SIDED|90.0|0.6|1.58|||Regression, Cox|||||1.58|0.60|0.92
72342905|NCT02888743|144209591|SUPERIORITY||Hazard Ratio (HR)|0.83||||0.55|TWO_SIDED|90.0|0.5|1.38|||Regression, Cox|||||1.38|0.50|0.55
72342906|NCT02888743|144209592|SUPERIORITY||Hazard Ratio (HR)|0.61||||0.24|TWO_SIDED|90.0|0.3|1.22|||Regression, Cox|||||1.22|0.30|0.24
72342907|NCT02888743|144209592|SUPERIORITY||Hazard Ratio (HR)|0.72||||0.44|TWO_SIDED|90.0|0.36|1.45|||Regression, Cox|||||1.45|0.36|0.44
72342908|NCT02888743|144209596|SUPERIORITY|||||||0.68||||||Unadjusted p-value.|Wilcoxon (Mann-Whitney)|||||||0.68
72342909|NCT06225466|144209597|SUPERIORITY||least squares mean difference|0.021|STANDARD_ERROR_OF_MEAN|0.013||0.123|TWO_SIDED|95.0|-0.005|0.047|||ANOVA|||||0.047|-0.005|0.123
72342910|NCT06225466|144209598|SUPERIORITY||Odds Ratio (OR)|0.55||||0.102|TWO_SIDED|95.0|0.26|1.12|||Mixed Models Analysis|||||1.12|0.26|0.102
72342911|NCT06225466|144209599|SUPERIORITY||Incidence rate ratio|2.37||||0.008|TWO_SIDED|95.0|1.25|4.52|||Negative Binomial Regression|||||4.52|1.25|0.008
72342912|NCT04816721|144209654|SUPERIORITY|The model included treatment group (EDP-938, placebo) and Day (3, 5, 9, and 14) as fixed effect, associated baseline, and treatment group by day interaction term as factors. An unstructured covariance matrix was imposed. The Satterthwaite approximation was used to estimate the denominator degrees of freedom.|Least Squares Mean Difference|-0.96||||0.1249|TWO_SIDED|95.0|-2.21|0.28|||Mixed-effect Model of Repeated Measures|||Day 3: EDP-938 Versus Placebo||0.28|-2.21|0.1249
72342913|NCT04816721|144209654|SUPERIORITY|The model included treatment group (EDP-938, placebo) and Day (3, 5, 9, and 14) as fixed effect, associated baseline, and treatment group by day interaction term as factors. An unstructured covariance matrix was imposed. The Satterthwaite approximation was used to estimate the denominator degrees of freedom.|Least Squares Mean Difference|-1.41||||0.058|TWO_SIDED|95.0|-2.88|0.05|||Mixed-effect Model of Repeated Measures|||Day 5: EDP-938 Versus Placebo||0.05|-2.88|0.0580
72342914|NCT04816721|144209654|SUPERIORITY|The model included treatment group (EDP-938, placebo) and Day (3, 5, 9, and 14) as fixed effect, associated baseline, and treatment group by day interaction term as factors. An unstructured covariance matrix was imposed. The Satterthwaite approximation was used to estimate the denominator degrees of freedom.|Least Squares Mean Difference|-0.43||||0.5877|TWO_SIDED|95.0|-2.02|1.16|||Mixed-effect Model of Repeated Measures|||Day 9: EDP-938 Versus Placebo||1.16|-2.02|0.5877
72342915|NCT04816721|144209654|SUPERIORITY|The model included treatment group (EDP-938, placebo) and Day (3, 5, 9, and 14) as fixed effect, associated baseline, and treatment group by day interaction term as factors. An unstructured covariance matrix was imposed. The Satterthwaite approximation was used to estimate the denominator degrees of freedom.|Least Squares Mean Difference|0.84||||0.2932|TWO_SIDED|95.0|-0.76|2.43|||Mixed-effect Model of Repeated Measures|||Day 14: EDP-938 Versus Placebo||2.43|-0.76|0.2932
72342916|NCT04816721|144209655|SUPERIORITY|The model included treatment group (EDP-938, placebo) and Day (3, 5, 9, and 14) as fixed effect, associated baseline, and treatment group by day interaction term as factors. An unstructured covariance matrix was imposed. The Satterthwaite approximation was used to estimate the denominator degrees of freedom.|Least Squares Mean Difference|-0.17||||0.6574|TWO_SIDED|95.0|-0.93|0.59|||Mixed-effect Model of Repeated Measures|||Day 3: EDP-938 Versus Placebo||0.59|-0.93|0.6574
72342917|NCT04816721|144209655|SUPERIORITY||Least Squares Mean Difference|-0.33||||0.4728|TWO_SIDED|95.0|-1.23|0.58|||Mixed-effect Model of Repeated Measures|||Day 5: EDP-938 Versus Placebo||0.58|-1.23|0.4728
72342918|NCT04816721|144209655|SUPERIORITY|The model included treatment group (EDP-938, placebo) and Day (3, 5, 9, and 14) as fixed effect, associated baseline, and treatment group by day interaction term as factors. An unstructured covariance matrix was imposed. The Satterthwaite approximation was used to estimate the denominator degrees of freedom.|Least Squares Mean Difference|-0.7||||0.2058|TWO_SIDED|95.0|-1.79|0.39|||Mixed-effect Model of Repeated Measures|||Day 9: EDP-938 Versus Placebo||0.39|-1.79|0.2058
72342919|NCT04816721|144209655|OTHER|The model included treatment group (EDP-938, placebo) and Day (3, 5, 9, and 14) as fixed effect, associated baseline, and treatment group by day interaction term as factors. An unstructured covariance matrix was imposed. The Satterthwaite approximation was used to estimate the denominator degrees of freedom.|Least Squares Mean Difference|0.33||||0.5391|TWO_SIDED|95.0|-0.74|1.41|||Mixed-effect Model of Repeated Measures|||Day 14: EDP-938 Versus Placebo||1.41|-0.74|0.5391
72342920|NCT04816721|144209657|SUPERIORITY|The model included treatment group (EDP-938, placebo) and Day (3, 5, 9, and 14) as fixed effect, associated baseline, and treatment group by day interaction term as factors. An unstructured covariance matrix was imposed. The Satterthwaite approximation was used to estimate the denominator degrees of freedom.|Least Squares Mean Difference|-0.17||||0.6574|TWO_SIDED|95.0|-0.93|0.59|||Mixed-effect Model of Repeated Measures|||Day 1 through Day 3: EDP-938 Versus Placebo||0.59|-0.93|0.6574
72342921|NCT04816721|144209657|SUPERIORITY|The model included treatment group (EDP-938, placebo) and Day (3, 5, 9, and 14) as fixed effect, associated baseline, and treatment group by day interaction term as factors. An unstructured covariance matrix was imposed. The Satterthwaite approximation was used to estimate the denominator degrees of freedom.|Least Squares Mean Difference|-0.67||||0.5359|TWO_SIDED|95.0|-2.81|1.47|||Mixed-effect Model of Repeated Measures|||Day 1 through Day 5: EDP-938 Versus Placebo||1.47|-2.81|0.5359
72342922|NCT04816721|144209657|SUPERIORITY|The model included treatment group (EDP-938, placebo) and Day (3, 5, 9, and 14) as fixed effect, associated baseline, and treatment group by day interaction term as factors. An unstructured covariance matrix was imposed. The Satterthwaite approximation was used to estimate the denominator degrees of freedom.|Least Squares Mean Difference|-2.73||||0.3029|TWO_SIDED|95.0|-7.95|2.5|||Mixed-effect Model of Repeated Measures|||Day 1 through Day 9: EDP-938 Versus Placebo||2.50|-7.95|0.3029
72342923|NCT04816721|144209657|SUPERIORITY|The model included treatment group (EDP-938, placebo) and Day (3, 5, 9, and 14) as fixed effect, associated baseline, and treatment group by day interaction term as factors. An unstructured covariance matrix was imposed. The Satterthwaite approximation was used to estimate the denominator degrees of freedom.|Least Squares Mean Difference|-3.64||||0.3871|TWO_SIDED|95.0|-11.98|4.69|||Mixed-effect Model of Repeated Measures|||Day 1 through Day 14: EDP-938 Versus Placebo||4.69|-11.98|0.3871
72342924|NCT00997620|144209770|OTHER||Mean Difference (Net)|0.5|||<|0.05|TWO_SIDED||||||t-test, 2 sided|||The statistical analysis was of t testing of the difference of the mean between the baseline and after two weeks. The power analysis was prior to data collection was not performed for this test. The null hypothesis is no different, no difference between placebo and active treatment.||||< .05
72342925|NCT00300365|144209788|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||||||<0.0001
72342926|NCT01716104|144209802|SUPERIORITY|||||||0.0005|||||||Mixed Models Analysis|||||||0.0005
72342927|NCT01716104|144209803|SUPERIORITY|||||||0.035|||||||Mixed Models Analysis|||||||0.035
72342928|NCT01716104|144209804|SUPERIORITY|||||||0.0008|||||||Mixed Models Analysis|||||||0.0008
72342929|NCT01716104|144209805|SUPERIORITY|||||||0.0011|||||||Mixed Models Analysis|||||||0.0011
72342930|NCT01716104|144209806|SUPERIORITY|||||||0.0054|||||||Mixed Models Analysis|||||||0.0054
72342931|NCT01716104|144209807|SUPERIORITY|||||||0.0437|||||||Mixed Models Analysis|||||||0.0437
72342932|NCT01716104|144209808|SUPERIORITY|||||||0.0862|||||||Mixed Models Analysis|||||||0.0862
72342933|NCT01716104|144209809|SUPERIORITY|||||||0.0621|||||||Mixed Models Analysis|||||||0.0621
72342934|NCT01716104|144209810|SUPERIORITY|||||||0.0142|||||||Mixed Models Analysis|||||||0.0142
72342935|NCT02522442|144209812|OTHER|Pilot study, not powered for any endpoint.||||||0.377|||||||Chi-squared|||Pilot study, not powered for any endpoint.||||0.377
72342936|NCT02522442|144209813|OTHER|Pilot study, not powered for any endpoint.||||||0.624|||||||Chi-squared|||||||.624
72342937|NCT02437084|144209937|OTHER|||||||0.01|||||||Paired samples t test, 2 sided|SSPG concentration was log-transformed for statistical analysis; degrees of freedom = 69||Null hypothesis: There will be no change in steady-state plasma glucose (SSPG) concentration after treatment with atorvastatin 40 mg daily for 9 - 10 weeks.||||0.01
72342938|NCT02437084|144209938|OTHER||||||<|0.001|||||||Paired samples t test, 2 sided|Insulin secretion rate AUC was log-transformed for statistical analysis; degrees of freedom = 63.||Null hypothesis: There will be no change in insulin secretion rate AUC after treatment with atorvastatin 40 mg daily for 9 - 10 weeks.||||<0.001
72370070|NCT04173494|144250575|OTHER||Stratified Cochran-Mantel-Haenszel|18.18||||0.0011|TWO_SIDED|95.0|9.77|26.59|||Cochran-Mantel-Haenszel|||||26.59|9.77|0.0011
72370071|NCT04173494|144250576|OTHER||Stratified Cochran-Mantel-Haenszel|17.2||||0.0012|TWO_SIDED|95.0|7.99|26.4|||Cochran-Mantel-Haenszel|||||26.40|7.99|0.0012
72370072|NCT04173494|144250577|OTHER||Stratified Cochran-Mantel-Haenszel|10.62||||0.1133|TWO_SIDED|95.0|-2.4|23.64|||Cochran-Mantel-Haenszel|||||23.64|-2.40|0.1133
72370073|NCT04173494|144250580|OTHER||Hazard Ratio (HR)|0.556||||0.0006|TWO_SIDED|95.0|0.397|0.778|||Anderson & Gill proportional means model|||||0.778|0.397|0.0006
72342939|NCT02437084|144209939|OTHER|||||||0.1|||||||Paired samples t test, 2 sided|Degrees of freedom = 70||Null hypothesis: There will be no change in fasting plasma glucose concentration after treatment with atorvastatin 40 mg daily for 8 - 10 weeks.||||0.10
72342940|NCT02437084|144209940|OTHER|||||||0.01|||||||Paired samples t test, 2 sided|Fasting plasma insulin concentration was log-transformed for statistical analysis; degrees of freedom = 68||Null hypothesis: There will be no change in fasting plasma insulin concentration after treatment with atorvastatin 40 mg daily for 8 - 10 weeks.||||0.01
72342941|NCT02437084|144209941|OTHER|||||||0.03|||||||Paired samples t test, 2 sided|Degrees of freedom = 70||Null hypothesis: There will be no change in OGTT glucose AUC after treatment with atorvastatin 40 mg daily for 8 - 10 weeks.||||0.03
72342942|NCT02437084|144209942|OTHER|||||||0.27|||||||Paired samples t test, 2 sided|OGTT insulin AUC was log-transformed for statistical analysis; degrees of freedom = 63||Null hypothesis: There will be no change in OGTT insulin AUC after treatment with atorvastatin 40 mg daily for 8 weeks.||||0.27
72342943|NCT01972789|144209985|NON_INFERIORITY|This is a non-inferiority study design, with a pre-specified non-inferiority margin of 5 letters between intensive and relaxed groups. That is, if the change from Baseline in BCVA at Month 24 in the intensive group is not more than 5 letters higher than the relaxed group, then the relaxed group is regarded not inferior to the intensive group|Odds Ratio (OR)|0.4||||0.787|TWO_SIDED|95.0|-2.51|3.32|||Mixed Models Analysis|||||3.32|-2.51|0.787
72342944|NCT01972789|144209986|OTHER||Odds Ratio (OR)|-0.31||||0.833|TWO_SIDED|95.0|-3.2|2.58|||Mixed Models Analysis|||||2.58|-3.20|0.833
72342945|NCT01972789|144209987|OTHER||Odds Ratio (OR)|-21.39||||0.054|TWO_SIDED|95.0|-43.17|0.39|||Mixed Models Analysis|||||0.39|-43.17|0.054
72342946|NCT01972789|144209988|OTHER||Negative Binomial Regression|1.11||||0.001|TWO_SIDED|95.0|1.04|1.18|||Mixed Model|||||1.18|1.04|0.001
72428649|NCT00654940|144368284|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.52|STANDARD_ERROR_OF_MEAN|2.493||||80.0|-3.82|2.78|||ANCOVA|||Neuropathic Pain Symptom Inventory treatment comparison: Pregabalin - Placebo. Total score was analyzed using a mixed effect analysis of covariance model based on the full analysis set (FAS), accounting for period and treatment effects. Subject was fitted as a random effect and baseline was fitted as two covariates.||2.78|-3.82|
72342947|NCT01972789|144209989|OTHER||Odds Ratio (OR)|0.26||||0.338|TWO_SIDED|95.0|-0.28|0.8|||Mixed Models Analysis|||||0.80|-0.28|0.338
72342948|NCT01972789|144209990|OTHER||Odds Ratio (OR)|1.44||||0.284|TWO_SIDED|95.0|0.74|2.8|||Regression, Logistic|||Month 12||2.80|0.74|0.284
72342949|NCT01972789|144209990|OTHER||Odds Ratio (OR)|1.29||||0.407|TWO_SIDED|95.0|0.71|2.33|||Regression, Logistic|||Month 24||2.33|0.71|0.407
72342950|NCT01972789|144209991|OTHER||Odds Ratio (OR)|0.35||||0.217|TWO_SIDED|95.0|0.12|1.04|||Regression, Logistic|||||1.04|0.12|0.217
72342951|NCT01972789|144209992|OTHER||Odds Ratio (OR)|0.84||||0.615|TWO_SIDED|95.0|0.42|1.66|||Regression, Logistic|||||1.66|0.42|0.615
72342952|NCT01972789|144209993|OTHER||Odds Ratio (OR)|1.08||||0.819|TWO_SIDED|95.0|0.54|2.18|||Regression, Logistic|||||2.18|0.54|0.819
72342953|NCT01972789|144209995|OTHER||Odds Ratio (OR)|4.32||||0.565|TWO_SIDED|95.0|0.03|630.5|||Regression, Logistic|||||630.5|0.03|0.565
72342954|NCT01972789|144209996|OTHER||Odds Ratio (OR)|1.39||||0.034|TWO_SIDED|95.0|1.03|1.9|||Regression, Logistic|||||1.90|1.03|0.034
72342955|NCT04407234|144210006|SUPERIORITY||Ratio of geometric least squares mean|0.881|||||TWO_SIDED|90.0|0.803|0.967|||Wilcoxon signed rank test|||||0.967|0.803|
72342956|NCT04407234|144210006|SUPERIORITY||Ratio of geometric least squares mean|1.16|||||TWO_SIDED|90.0|1.05|1.28|||Wilcoxon signed rank test|||||1.28|1.05|
72342957|NCT04407234|144210007|SUPERIORITY||Ratio of geometric least squares mean|0.446|||||TWO_SIDED|90.0|0.39|0.509|||Wilcoxon signed rank test|||||0.509|0.390|
72342958|NCT04407234|144210007|SUPERIORITY||Ratio of geometric least squares mean|0.679|||||TWO_SIDED|90.0|0.589|0.783|||Wilcoxon signed rank test|||||0.783|0.589|
72342959|NCT04407234|144210009|SUPERIORITY||Ratio of geometricleast squares mean|0.888|||||TWO_SIDED|90.0|0.778|1.01||||||||1.01|0.778|
72342960|NCT04407234|144210009|SUPERIORITY||Ratio of geometricleast squares mean|1.23|||||TWO_SIDED|90.0|1.07|1.42||||||||1.42|1.07|
72342961|NCT04407234|144210010|SUPERIORITY||Ratio of geometricleast squares mean|0.875|||||TWO_SIDED|90.0|0.766|0.999||||||||0.999|0.766|
72342962|NCT04407234|144210010|SUPERIORITY||Ratio of geometricleast squares mean|1.08|||||TWO_SIDED|90.0|0.938|1.25||||||||1.25|0.938|
72342963|NCT04407234|144210011|SUPERIORITY||Ratio of geometricleast squares mean|0.453|||||TWO_SIDED|90.0|0.376|0.545||||||||0.545|0.376|
72342964|NCT04407234|144210011|SUPERIORITY||Ratio of geometricleast squares mean|0.804|||||TWO_SIDED|90.0|0.66|0.979||||||||0.979|0.660|
72342965|NCT04407234|144210012|SUPERIORITY||Ratio of geometricleast squares mean|0.438|||||TWO_SIDED|90.0|0.364|0.527||||||||0.527|0.364|
72342966|NCT04407234|144210012|SUPERIORITY||Ratio of geometricleast squares mean|0.574|||||TWO_SIDED|90.0|0.471|0.698||||||||0.698|0.471|
72342967|NCT00727558|144210013|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.554|STANDARD_ERROR_OF_MEAN|0.1943||||97.47|0.1721|0.554|||Mixed Models Analysis||The mean difference is narafilcon A minus nelfilcon A.|Alternative hypothesis: narafilcon A is superior to nelfilcon A||0.554|0.1721|
72342968|NCT00727558|144210014|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1734|STANDARD_ERROR_OF_MEAN|0.03555||||97.47|-0.1734|-0.1037|||Mixed Models Analysis||Mean difference is narafilcon A minus nelfilcon A|Alternative hypothesis: narafilcon A is superior to nelfilcon A.||-0.1037|-0.1734|
72342969|NCT00727558|144210015|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.3968|STANDARD_ERROR_OF_MEAN|0.1548||||98.7|0.04983|0.3968|||Mixed Models Analysis||The mean difference is narafilcon A minus nelfilcon A.|Alternative hypothesis: narafilcon A is superior to nelfilcon A||0.3968|0.04983|
72342970|NCT00727558|144210016|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3875|STANDARD_ERROR_OF_MEAN|0.2054||||98.7|0.03714|0.3875|||Mixed Models Analysis||The mean difference is narafilcon A minus nelfilcon A.|Alternative hypothesis: narafilcon A is superior to nelfilcon A.||0.3875|0.03714|
72342971|NCT00727558|144210017|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.6735|STANDARD_ERROR_OF_MEAN|0.1563||||98.7|0.213|0.6735|||Mixed Models Analysis||The mean difference is narafilcon A minus nelfilcon A.|Alternative hypothesis: narafilcon A is superior to nelfilcon A||0.6735|0.213|
72342972|NCT00727558|144210018|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.132|STANDARD_ERROR_OF_MEAN|0.1648||||98.7|-0.2375|0.132|||Mixed Models Analysis||Mean difference is narafilcon A minus nelfilcon A.|Alternative hypothesis: narafilcon A is superior to nelfilcon A||0.132|-0.2375|
72342973|NCT00727558|144210019|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2469|STANDARD_ERROR_OF_MEAN|0.04448||||97.47|-0.2469|-0.1599|||Mixed Models Analysis||The mean difference is narafilcon A minus nelfilcon A.|Alternative hypothesis: narafilcon A is superior to nelfilcon A by having a lower level of inferior region corneal staining||-0.1599|-0.2469|
72342974|NCT03268941|144210035|OTHER||Least Square (LS) Mean Difference|7.38|||<|0.001|TWO_SIDED|95.0|4.03|13.52||ANCOVA model was used for analysis. Treatment, underlying disease (DG/IG) were fixed factors. ln of baseline prolactin concentration as covariate, ln of ratio of Cmax to baseline concentration as response. Results in original scale are presented.|ANCOVA|||Change in serum prolactin on Day 1 at the Tmax as a ratio of Cmax to serum prolactin concentration at Baseline.||13.52|4.03|<0.001
72342975|NCT03268941|144210035|OTHER||LS Mean Difference|11.24|||<|0.001|TWO_SIDED|95.0|5.91|21.41||ANCOVA model was used for analysis. Treatment, underlying disease (DG/IG) were fixed factors. ln of baseline prolactin concentration as covariate, ln of ratio of Cmax to baseline concentration as response. Results in original scale are presented.|ANCOVA|||Change in serum prolactin on Day 1 at the Tmax as a ratio of Cmax to serum prolactin concentration at Baseline.||21.41|5.91|<0.001
72342976|NCT03268941|144210035|OTHER||LS Mean Difference|12.8|||<|0.001|TWO_SIDED|95.0|6.94|23.59||ANCOVA model was used for analysis. Treatment, underlying disease (DG/IG) were fixed factors. ln of baseline prolactin concentration - covariate, ln of ratio of Cmax to baseline concentration as response. Results in original scale are presented.|ANCOVA|||Change in serum prolactin on Day 1 at the Tmax as a ratio of Cmax to serum prolactin concentration at Baseline.||23.59|6.94|<0.001
72342977|NCT03268941|144210036|OTHER||LS Mean Difference|7.76|STANDARD_ERROR_OF_MEAN|14.648||0.599|TWO_SIDED|95.0|-21.89|37.41||P-value was obtained by ANCOVA model with treatment and underlying disease (DG/IG) condition as fixed factors and baseline score as covariate.|ANCOVA|||Change from Baseline in GEBT gastric half-emptying time on Day 7 in Part 1.||37.41|-21.89|0.599
72342978|NCT03268941|144210036|OTHER||LS Mean Difference|6.28|STANDARD_ERROR_OF_MEAN|15.469||0.687|TWO_SIDED|95.0|-25.04|37.59||P-value was obtained by ANCOVA model with treatment and underlying disease (DG/IG) condition as fixed factors and baseline score as covariate.|ANCOVA|||Change from Baseline in GEBT gastric half-emptying time on Day 7 in Part 1.||37.59|-25.04|0.687
72342979|NCT03268941|144210036|OTHER||LS Mean Difference|8.05|STANDARD_ERROR_OF_MEAN|15.45||0.605|TWO_SIDED|95.0|-23.22|39.33||P-value was obtained by ANCOVA model with treatment and underlying disease (DG/IG) condition as fixed factors and baseline score as covariate.|ANCOVA|||Change from Baseline in GEBT gastric half-emptying time on Day 7 in Part 1.||39.33|-23.22|0.605
72342980|NCT03268941|144210037|OTHER||LS Mean Difference|7.56|STANDARD_ERROR_OF_MEAN|11.708||0.522|TWO_SIDED|95.0|-16.06|31.19||P-value was obtained by ANCOVA model with treatment and underlying disease (DG/IG) condition as fixed factors and baseline score as covariate.|ANCOVA|||Change from Baseline in GEBT gastric half-emptying time on Day 1 in Part 1.||31.19|-16.06|0.522
72342981|NCT03268941|144210037|OTHER||LS Mean Difference|12.92|STANDARD_ERROR_OF_MEAN|12.143||0.293|TWO_SIDED|95.0|-11.58|37.43||P-value was obtained by ANCOVA model with treatment and underlying disease (DG/IG) condition as fixed factors and baseline score as covariate.|ANCOVA|||Change from Baseline in GEBT gastric half-emptying time on Day 1 in Part 1.||37.43|-11.58|0.293
72342982|NCT03268941|144210037|OTHER||LS Mean Difference|7.0|STANDARD_ERROR_OF_MEAN|11.654||0.551|TWO_SIDED|95.0|-16.52|30.52||P-value was obtained by ANCOVA model with treatment and underlying disease (DG/IG) condition as fixed factors and baseline score as covariate.|ANCOVA|||Change from Baseline in GEBT gastric half-emptying time on Day 1 in Part 1.||30.52|-16.52|0.551
72342983|NCT03268941|144210038|OTHER||Hodges-Lehmann Estimate of Median Diff|-18.14||||0.274|TWO_SIDED|95.0|-307.58|13.56||P-value was obtained with pairwise Wilcoxon Rank Sum tests.|Wilcoxon Rank Sum tests|||Percent Change in GE time measured by the SmartPill on Day 7 in Part 1.||13.56|-307.58|0.274
72342984|NCT03268941|144210038|OTHER||Hodges-Lehmann Estimate of Median Diff|-26.95||||0.481|TWO_SIDED|95.0|-229.73|530.49||P-value was obtained with pairwise Wilcoxon Rank Sum tests.|Wilcoxon Rank Sum tests|||Percent Change in GE time measured by the SmartPill on Day 7 in Part 1.||530.49|-229.73|0.481
72342985|NCT03268941|144210038|OTHER||Hodges-Lehmann Estimate of Median Diff|-24.49||||0.382|TWO_SIDED|95.0|-225.87|98.91||P-value was obtained with pairwise Wilcoxon Rank Sum tests.|Wilcoxon Rank Sum tests|||Percent Change in GE on time measured by the SmartPill Day 7 in Part 1.||98.91|-225.87|0.382
72342986|NCT01216683|144210043|SUPERIORITY|||||||0.02||||||one-sided p-value|Cochran-Mantel-Haenszel|||The study was designed to detect a 16% difference in CR rate from 50% in the Bendamustine + Rituximab arms to 66% in the Bendamustine + Rituximab + Bortezomib arm, with 90% power at the one-sided alpha 0.15 level.||||0.02
72342987|NCT01216683|144210044|SUPERIORITY|||||||0.02|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified on Groupe d'Etude des Lymphomes Folliculaires status and Follicular Lymphoma International Prognostic Index||||||0.02
72342988|NCT02702180|144210129|SUPERIORITY||Least Square Means (LSmean)|-4.6||||0.1688|TWO_SIDED|95.0|-11.1|2.0|||ANCOVA||The estimated value represents the estimated difference between once daily molgramostim and placebo groups in LSmean change from baseline to week 24.|Primary endpoint was evaluated using analysis of covariance with treatment, whole lung lavage within 2 months before baseline, and geographic region as factors, and baseline values as covariates. To control type I error, key secondary endpoints were analyzed using a testing hierarchy wherein once daily molgramostim and placebo was compared and if statistical significance was reached, evaluation of intermittent molgramostim and placebo would proceed.||2.0|-11.1|0.1688
72342989|NCT02702180|144210129|SUPERIORITY||Least Square Means (LSmean)|-2.8||||0.3968|TWO_SIDED|95.0|-9.3|3.7|||ANCOVA||The estimated value represents the estimated difference between intermittent molgramostim and placebo groups in LSmean change from baseline to week 24.|||3.7|-9.3|0.3968
72342990|NCT02702180|144210130|SUPERIORITY||Least Square Means (LSmean)|20.6||||0.3159|TWO_SIDED|95.0|-19.8|61.0|||ANCOVA||The estimated value represents the estimated difference between once daily molgramostim and placebo groups in LSmean change from baseline to week 24.|||61.0|-19.8|0.3159
72342991|NCT02702180|144210130|SUPERIORITY||Least Square Means (LSmean)|5.6||||0.7809|TWO_SIDED|95.0|-34.1|45.2|||ANCOVA||The estimated value represents the estimated difference between intermittent molgramostim and placebo groups in LSmean change from baseline to week 24.|||45.2|-34.1|0.7809
72342992|NCT02702180|144210131|SUPERIORITY||Least Square Means (LSmean)|-7.6||||0.0103|TWO_SIDED|95.0|-13.4|-1.8|||ANCOVA||The estimated value represents the estimated difference between once daily molgramostim and placebo groups in LSmean change from baseline to week 24.|||-1.8|-13.4|0.0103
72342993|NCT02702180|144210131|SUPERIORITY||Least Square Means (LSmean)|-7.0||||0.0173|TWO_SIDED|95.0|-12.7|-1.3|||ANCOVA||The estimated value represents the estimated difference between intermittent molgramostim and placebo groups in LSmean change from baseline to week 24..|||-1.3|-12.7|0.0173
72342994|NCT02702180|144210132|SUPERIORITY||Risk Ratio (RR)|0.284||||0.1918|TWO_SIDED|95.0|0.043|1.881|||Negative binomial regression||The estimated value represents the RR between once daily molgramostim and placebo groups.|||1.881|0.043|0.1918
72342995|NCT02702180|144210132|SUPERIORITY||Risk Ratio (RR)|0.367||||0.2421|TWO_SIDED|95.0|0.068|1.968|||Negative binomial regression||The estimated value represents the RR between intermittent molgramostim and placebo groups.|||1.968|0.068|0.2421
72342996|NCT03626545|144210147|SUPERIORITY||Hazard Ratio (HR)|1.06||||0.633|TWO_SIDED|95.0|0.76|1.48|||Log Rank||Hazard ratio was estimated using a Cox Proportional Hazards regression model stratified by line of therapy and histology|||1.48|0.76|0.633
72342997|NCT01452919|144210171|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|-1.73|STANDARD_ERROR_OF_MEAN|1.25||0.17||95.0||||Two-sided p-value.|Type 3 sums of squares|||||||0.170
72342998|NCT01452919|144210172|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|0.8|STANDARD_ERROR_OF_MEAN|0.5||0.109||95.0||||Two-sided p-value. P-value is for Week 0.5.|Type 3 sums of squares|||||||0.109
72342999|NCT01452919|144210172|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|0.4|STANDARD_ERROR_OF_MEAN|0.4||0.372||95.0||||Two-sided p-value. P-value is for Week 1.|Type 3 sums of squares|||||||0.372
72343000|NCT01452919|144210172|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|0.2|STANDARD_ERROR_OF_MEAN|0.4||0.555||95.0||||Two-sided p-value. P-value is for Week 1.5.|Type 3 sums of squares|||||||0.555
72428650|NCT00654940|144368285|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|29000.0|STANDARD_ERROR_OF_MEAN|17000.0||||80.0|6100.0|51000.0|||ANCOVA|||Difference in least squares means Pregabalin-Placebo. Model of day (8 am to 8 pm) total activity score at end of treatment. Mixed effects analysis of covariance model was fitted on the full analysis set population, accounting for period and treatment effects. Subject was fitted as a random effect and baseline was fitted as two covariates.||51000|6100|
72343001|NCT01452919|144210172|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|-0.1|STANDARD_ERROR_OF_MEAN|0.4||0.806||95.0||||Two-sided p-value. P-value is for Week 2.|Type 3 sums of squares|||||||0.806
72428651|NCT04834362|144368328|OTHER|||||||0.677|||||||t-test, 2 sided|||||||0.677
72428652|NCT04834362|144368329|OTHER|||||||0.053|||||||t-test, 2 sided|||||||0.053
72343002|NCT01452919|144210173|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|0.0|STANDARD_ERROR_OF_MEAN|0.0||0.762||95.0||||Two-sided p-value.|Type 3 sums of squares|||||||0.762
72343003|NCT01452919|144210174|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|0.0|STANDARD_ERROR_OF_MEAN|0.1||0.506||95.0||||Two-sided p-value.|Type 3 sums of squares|||||||0.506
72343004|NCT01452919|144210175|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|-0.1|STANDARD_ERROR_OF_MEAN|0.1||0.515||95.0||||Two-sided p-value.|Type 3 sums of squares|||||||0.515
72343005|NCT01452919|144210178|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|0.2|STANDARD_ERROR_OF_MEAN|0.1||0.966||95.0||||One-sided p-value.|Type 3 sums of squares|||||||0.966
72343006|NCT01452919|144210179|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|0.92|STANDARD_ERROR_OF_MEAN|0.73||0.895||95.0||||One-sided p-value.|Type 3 sums of squares|||||||0.895
72343007|NCT02421588|144210180|SUPERIORITY||Hazard Ratio (HR)|1.057||||0.6294|TWO_SIDED|95.0|0.854|1.309|||Log Rank|||PFS between treatments||1.309|0.854|0.6294
72343008|NCT02421588|144210180|SUPERIORITY||PFS at 6 months|24.3|||||TWO_SIDED|95.0|18.4|30.7|||||Percent of Participants|PFS (%) at 6 months||30.7|18.4|
72343009|NCT02421588|144210180|SUPERIORITY||PFS at 6 months|27.5|||||TWO_SIDED|95.0|20.9|34.4|||||Percent of Participants|PFS (%) at 6 months||34.4|20.9|
72343010|NCT02421588|144210180|SUPERIORITY|||||||0.5032|||||||Normal approximation|||PFS (%) at 6 months between treatments||||0.5032
72343011|NCT02421588|144210180|SUPERIORITY||PFS at 12 months|8.3|||||TWO_SIDED|95.0|4.7|13.3|||||Percent of Participants|PFS (%) at 12 months||13.3|4.7|
72343012|NCT02421588|144210180|SUPERIORITY||PFS at 12 months|7.0|||||TWO_SIDED|95.0|3.3|12.5|||||Percent of Participants|PFS (%) at 12 months||12.5|3.3|
72343013|NCT02421588|144210180|SUPERIORITY|||||||0.6742|||||||Normal approximation|||PFS (%) at 12 months between treatments||||0.6742
72343014|NCT02421588|144210181|SUPERIORITY||Hazard Ratio (HR)|0.987||||0.7673|TWO_SIDED|95.0|0.805|1.209|||Log Rank|||PFS between treatments||1.209|0.805|0.7673
72343015|NCT02421588|144210181|SUPERIORITY||PFS at 6 months|29.0|||||TWO_SIDED|95.0|22.8|35.4|||||Percent of Participants|PFS (%) at 6 months||35.4|22.8|
72343016|NCT02421588|144210181|SUPERIORITY||PFS at 6 months|27.4|||||TWO_SIDED|95.0|21.3|33.9|||||Percent of Participants|PFS (%) at 6 months||33.9|21.3|
72343017|NCT02421588|144210181|SUPERIORITY|||||||0.7385|||||||Normal approximation|||PFS (%) at 6 months between treatments||||0.7385
72343018|NCT02421588|144210181|SUPERIORITY||PFS (%) at 12 months|8.2|||||TWO_SIDED|95.0|4.8|12.7|||||Percent of Participants|PFS (%) at 12 months||12.7|4.8|
72343019|NCT02421588|144210181|SUPERIORITY||PFS (%) at 12 months|7.5|||||TWO_SIDED|95.0|4.2|12.2|||||Percent of Participants|PFS (%) at 12 months||12.2|4.2|
72343020|NCT02421588|144210181|SUPERIORITY|||||||0.8245|||||||Normal approximation|||PFS (%) at 12 months between treatments||||0.8245
72343021|NCT02421588|144210182|SUPERIORITY||Hazard Ratio (HR)|0.956||||0.8021|TWO_SIDED|95.0|0.772|1.183|||Log Rank|||OS between treatments||1.183|0.772|0.8021
72343022|NCT02421588|144210182|SUPERIORITY||OS at 12 months|48.2|||||TWO_SIDED|95.0|41.3|54.8|||||Percent of Participants|OS (%) at 12 months||54.8|41.3|
72343023|NCT02421588|144210182|SUPERIORITY||OS (%) at 12 months|45.3|||||TWO_SIDED|95.0|38.4|52.0|||||Percent of Participants|OS (%) at 12 months||52.0|38.4|
72343024|NCT02421588|144210182|SUPERIORITY|||||||0.5515|||||||Normal approximation|||OS (%) at 12 months between treatments||||0.5515
72343025|NCT02421588|144210182|SUPERIORITY||OS (%) at 24 months|22.3|||||TWO_SIDED|95.0|16.8|28.2|||||Percent of Participants|OS (%) at 24 months||28.2|16.8|
72343026|NCT02421588|144210182|SUPERIORITY||OS (%) at 24 months|22.7|||||TWO_SIDED|95.0|17.1|28.7|||||Percent of Participants|OS (%) at 24 months||28.7|17.1|
72428653|NCT04834362|144368330|OTHER|||||||0.918|||||||t-test, 2 sided|||||||0.918
72428654|NCT04834362|144368331|OTHER|||||||0.729|||||||Chi-squared|||||||0.729
72343027|NCT02421588|144210182|SUPERIORITY|||||||0.9253|||||||Normal approximation|||OS (%) at 24 months between treatments||||0.9253
72343028|NCT02421588|144210183|SUPERIORITY||ORR|14.5|||||TWO_SIDED|95.0|10.1|19.8|||||Percent of Participants|Overall response rate||19.8|10.1|
72343029|NCT02421588|144210183|SUPERIORITY||ORR|12.7|||||TWO_SIDED|95.0|8.6|17.8|||||Percent of Participants|Overall response rate||17.8|8.6|
72343030|NCT02421588|144210183|SUPERIORITY|||||||0.6772|||||||Fisher Exact|||Overall response rate between treatments||||0.6772
72343031|NCT02421588|144210184|SUPERIORITY||ORR|15.8|||||TWO_SIDED|95.0|11.3|21.3|||||Percent of Participants|Overall response rate (ORR)||21.3|11.3|
72343032|NCT02421588|144210184|SUPERIORITY||Overall response rate (ORR)|16.7|||||TWO_SIDED|95.0|12.1|22.3|||||Percent of Participants|Overall response rate (ORR)||22.3|12.1|
72343033|NCT02421588|144210184|SUPERIORITY|||||||0.8976|||||||Fisher Exact|||Overall response rate (ORR) between treatments||||0.8976
72343034|NCT02421588|144210185|SUPERIORITY||Hazard Ratio (HR)|1.406||||0.2631|TWO_SIDED|95.0|0.769|2.569|||Log Rank|||Duration of response between treatments||2.569|0.769|0.2631
72343035|NCT02421588|144210186|SUPERIORITY|Duration of response between treatments|Hazard Ratio (HR)|1.056||||0.8276|TWO_SIDED|95.0|0.64|1.743|||Log Rank|||||1.743|0.64|0.8276
72343036|NCT02421588|144210187|SUPERIORITY||ORR (%)|26.6|||||TWO_SIDED|95.0|20.2|33.8|||||Percent of Participants|ORR (%) by CA-125||33.8|20.2|
72343037|NCT02421588|144210187|SUPERIORITY||ORR (%)|19.4|||||TWO_SIDED|95.0|13.7|26.3|||||Percent of Participants|ORR (%) by CA-125||26.3|13.7|
72343038|NCT02421588|144210187|SUPERIORITY|||||||0.1231|||||||Fisher Exact|||ORR (%) by CA-125 between treatments||||0.1231
72343039|NCT03194646|144210215|OTHER||Mean Difference (Final Values)|-1.85|||||TWO_SIDED|95.0|-2.44|-1.26||||||||-1.26|-2.44|
72428655|NCT01755689|144368337|NON_INFERIORITY|The non-inferiority criteria: the upper limit (UL) of the 2-sided standardised asymptotic 95% confidence interval (CI) for the ratio of rSBA GMTs had to be below the pre-defined limit of 2.|Adjusted GMT Ratio|1.19|||||TWO_SIDED|95.0|0.99|1.43|||ANCOVA|||Adjusted GMT ratio of the Nimenrix Group versus Nimenrix+Cervarix+Boostrix Group in terms of rSBA-MenA titers.||1.43|0.99|
72343040|NCT03194646|144210215|OTHER||Mean Difference (Final Values)|-2.34|||||TWO_SIDED|95.0|-2.87|-1.8||||||||-1.80|-2.87|
72343041|NCT03194646|144210215|OTHER||Mean Difference (Final Values)|-1.81|||||TWO_SIDED|95.0|-2.51|-1.1||||||||-1.10|-2.51|
72343042|NCT00510744|144210245|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|24.0|<|0.05|TWO_SIDED||||||t-test, 2 sided|||paired changes in fat absorption assessed by parametric (t test) or non-parametric tests (Mann-Whitney)||||<0.05
72343043|NCT03836677|144210269|OTHER||Geometric Mean ratio to baseline|1.72|||<|0.0001|TWO_SIDED|95.0|1.38|2.13||Statistical significance assessed using Hochberg's procedure applied across primary endpoints within each treatment.|t-test, 2 sided|Within-group comparison to baseline using paired test||||2.13|1.38|<0.0001
72343044|NCT03836677|144210269|OTHER||Geometric mean ratio to baseline|1.53|||<|0.0001|TWO_SIDED|95.0|1.28|1.83||Statistical significance assessed using Hochberg's procedure applied across primary endpoints within each treatment.|t-test, 2 sided|Within-group comparison to baseline using paired test.||||1.83|1.28|<0.0001
72343045|NCT03836677|144210270|OTHER||Geometric mean ratio to baseline|0.5|||<|0.0001|TWO_SIDED|95.0|0.39|0.63||Statistical significance assessed using Hochberg's procedure applied across primary endpoints within each treatment.|t-test, 2 sided|Within-group comparison to baseline using paired test||||0.63|0.39|<0.0001
72343046|NCT03836677|144210270|OTHER||Geometric mean ratio to baseline|0.52|||<|0.0001|TWO_SIDED|95.0|0.4|0.67||Statistical significance assessed using Hochberg's procedure applied across primary endpoints within each treatment.|t-test, 2 sided|Within-group comparison to baseline using paired test||||0.67|0.40|<0.0001
72343047|NCT03836677|144210271|OTHER||Geometric mean ratio to baseline|1.7|||<|0.0001||95.0|1.37|2.11|||t-test, 2 sided|Within-group comparison to baseline using paired test||||2.11|1.37|<0.0001
72343048|NCT03836677|144210271|OTHER||Geometric mean ratio to baseline|1.51||||0.0001|TWO_SIDED|95.0|1.26|1.8|||t-test, 2 sided|Within-group comparison to baseline using paired test||||1.80|1.26|0.0001
72343049|NCT03836677|144210272|OTHER||Geometric mean ratio to baseline|0.5|||<|0.0001|TWO_SIDED|95.0|0.4|0.63|||t-test, 2 sided|Within-group comparison to baseline using paired test||||0.63|0.40|<0.0001
72343050|NCT03836677|144210272|OTHER||Geometric mean ratio to baseline|0.52|||<|0.0001|TWO_SIDED|95.0|0.4|0.68|||t-test, 2 sided|Within-group comparison to baseline using paired test||||0.68|0.40|<0.0001
72343051|NCT03836677|144210273|OTHER||Mean Change from Baseline|0.346||||0.0003|TWO_SIDED|95.0|0.182|0.509|||t-test, 2 sided|Within-group comparison to baseline using paired test.||||0.509|0.182|0.0003
72343052|NCT03836677|144210273|OTHER||Mean Change from Baseline|0.273||||0.0004|TWO_SIDED|95.0|0.14|0.405|||t-test, 2 sided|Within-group comparison to baseline using paired test.||||0.405|0.140|0.0004
72343053|NCT03836677|144210274|OTHER||Mean ratio to baseline|-0.28||||0.2515|TWO_SIDED|95.0|-0.77|0.21|||t-test, 2 sided|Within-group comparison to baseline using paired test.||||0.21|-0.77|0.2515
72343054|NCT03836677|144210274|OTHER||Mean ratio to baseline|-0.5||||0.004|TWO_SIDED|95.0|-0.81|-0.18|||t-test, 2 sided|Within-group comparison to baseline using paired test.||||-0.18|-0.81|0.0040
72343055|NCT00462748|144210302|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||Hochberg's FDR was used to power the study; the power was based on a two-sided p value of 0.025.|Regression, Logistic|The logistic regression model included terms for treatment and stratum; treatment by stratum interaction was assessed.||Ho is no difference in proportion achieving the target of LDL-C \< 2mmol/l.. 240 patients per group give a power of at least 85% to detect a 15% difference in this proportion, assuming the percentage decrease from baseline in LDL-C was 25% in the E/S group and 15% in the two comparator groups. A two-sided 0.025 test to allow for multiple comparisons was used.||||<0.001
72343056|NCT00462748|144210302|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||Hochberg's FDR was used to power the study; the power was based on a two-sided p value of 0.025.|Regression, Logistic|The logistic regression model included terms for treatment and stratum; treatment by stratum interaction was assessed.||Ho is no difference in proportion achieving the target of LDL-C \< 2mmol/l.. 240 patients per group give a power of at least 85% to detect a 15% difference in this proportion, assuming the percentage decrease from baseline in LDL-C was 25% in the E/S group and 15% in the two comparator groups. A two-sided 0.025 test to allow for multiple comparisons was used.||||<0.001
72343057|NCT03233438|144210303|SUPERIORITY||Mean Difference (Final Values)|1.6|STANDARD_DEVIATION|2.5||0.003|TWO_SIDED|95.0|0.6|2.6|||t-test, 2 sided|||||2.6|0.6|0.003
72343058|NCT03233438|144210304|SUPERIORITY||Mean Difference (Final Values)|1.7|STANDARD_DEVIATION|2.56||0.003|TWO_SIDED|95.0|0.6|2.8|||t-test, 2 sided|||||2.8|0.6|0.003
72343059|NCT03429543|144210334|OTHER||Mean Difference (Final Values)|-0.34|STANDARD_ERROR_OF_MEAN|0.33||0.2935|TWO_SIDED|95.0|-0.99|0.3|||ANCOVA||Mean difference calculated as \[Treatment\] - Placebo.|Treatment group 1 (TG1) consisting of Placebo, Linagliptin 5 mg and Empagliflozin pooled Patients: Analysis of covariance (ANCOVA) model with a continuous covariate (baseline HbA1c) and categorical covariates (treatment and age). The effect of linagliptin and of empagliflozin (including responders and non-responders) was compared with placebo at an overall α of 0.05 (2-sided) using the Hochberg method to account for multiple testing.||0.30|-0.99|0.2935
72343060|NCT03429543|144210334|OTHER||Mean Difference (Final Values)|-0.84|STANDARD_ERROR_OF_MEAN|0.33||0.0116|TWO_SIDED|95.0|-1.5|-0.19|||ANCOVA||Mean difference calculated as \[Treatment\] - Placebo.|Treatment group 1 (TG1) consisting of Placebo, Linagliptin 5 mg and Empagliflozin pooled Patients: Analysis of covariance (ANCOVA) model with a continuous covariate (baseline HbA1c) and categorical covariates (treatment and age). The effect of linagliptin and of empagliflozin (including responders and non-responders) was compared with placebo at an overall α of 0.05 (2-sided) using the Hochberg method to account for multiple testing.||-0.19|-1.50|0.0116
72343061|NCT03429543|144210334|OTHER|Only after having obtained statistically significant results for both hypotheses of the primary family of hypotheses (TG1), the secondary hypotheses were to compare the individual empagliflozin doses versus placebo based on TG2 and TG3.The ANCOVA utilised a weight of zero for patients who were not in the hypothesis test of interest, a value of 2 for re-randomised patients who were in the hypothesis test of interest and a value of 1 otherwise.|Mean Difference (Final Values)|-0.52|STANDARD_ERROR_OF_MEAN|0.4||0.1943|TWO_SIDED|95.0|-1.31|0.27|||ANCOVA||Mean difference calculated as \[Treatment\] - Placebo.|Treatment group 2 (TG2) consisting of Placebo, Empagliflozin 25mg Patients: Analysis of covariance (ANCOVA) model with a continuous covariate (baseline HbA1c) and categorical covariates (treatment and age). The effect of linagliptin and of empagliflozin (including responders and non-responders) was compared with placebo at an overall α of 0.05 (2-sided) using the Hochberg method to account for multiple testing.||0.27|-1.31|0.1943
72343062|NCT03429543|144210334|OTHER|Only after having obtained statistically significant results for both hypotheses of the primary family of hypotheses (TG1), the secondary hypotheses were to compare the individual empagliflozin doses versus placebo based on TG2 and TG3.The ANCOVA utilised a weight of zero for patients who were not in the hypothesis test of interest, a value of 2 for re-randomised patients who were in the hypothesis test of interest and a value of 1 otherwise.|Mean Difference (Final Values)|-1.18|STANDARD_ERROR_OF_MEAN|0.37||0.0015|TWO_SIDED|95.0|-1.9|-0.45|||ANCOVA||Mean difference calculated as \[Treatment\] - Placebo.|Treatment group 3 (TG3) consisting of Placebo, Empagliflozin 10mg Patients: Analysis of covariance (ANCOVA) model with a continuous covariate (baseline HbA1c) and categorical covariates (treatment and age). The effect of linagliptin and of empagliflozin (including responders and non-responders) was compared with placebo at an overall α of 0.05 (2-sided) using the Hochberg method to account for multiple testing.||-0.45|-1.90|0.0015
72343063|NCT03429543|144210335|OTHER||Risk Difference (RD)|-10.0||||1|TWO_SIDED|90.0|-58.7|43.7|||Fisher Exact||Risk difference calculated as \[treatment\]-\[placebo\].|Risk difference of active treatments versus placebo was determined and assessed by an exact 2-sided 90% confidence interval based on the method of Chan and Zhang. Patients were assigned to the treatment they were randomised to at the initial randomisation.||43.7|-58.7|1.0000
72343064|NCT03429543|144210335|OTHER||Risk Difference (RD)|-10.0||||1|TWO_SIDED|90.0|-58.7|43.7|||Fisher Exact||Risk difference calculated as \[treatment\]-\[placebo\].|Risk difference of active treatments versus placebo was determined and assessed by an exact 2-sided 90% confidence interval based on the method of Chan and Zhang. Patients were assigned to the treatment they were randomised to at the initial randomisation.||43.7|-58.7|1.0000
72343065|NCT03429543|144210336|OTHER||Adjusted mean difference|-0.68||||0.4828|TWO_SIDED|95.0|-2.86|1.49|||Mixed Models Analysis||Mean difference calculated as \[Treatment\] - Placebo.|Restricted maximum likelihood (REML) approach with mixed model for repeated measures (MMRM). Fixed categorical effects of treatment, visit, and treatment-by-visit interaction and categorical covariate age (baseline) and continuous, fixed covariates of baseline of response variable and baseline of response variable-by-visit interaction. Covariate visit was treated as repeated measure with an unstructured covariance structure used to model within-patient measurements.||1.49|-2.86|0.4828
72343066|NCT03429543|144210336|OTHER||Adjusted mean difference|-0.38||||0.7047|TWO_SIDED|95.0|-2.64|1.88|||Mixed Models Analysis||Mean difference calculated as \[Treatment\] - Placebo.|Restricted maximum likelihood (REML) approach with mixed model for repeated measures (MMRM). Fixed categorical effects of treatment, visit, and treatment-by-visit interaction and categorical covariate age (baseline) and continuous, fixed covariates of baseline of response variable and baseline of response variable-by-visit interaction. Covariate visit was treated as repeated measure with an unstructured covariance structure used to model within-patient measurements.||1.88|-2.64|0.7047
72343067|NCT03429543|144210337|OTHER|||||||0.8626|||||||Log Rank|||Time to treatment failure was analysed by Kaplan-Meier estimates up to the end of the study. A log-rank test compared linagliptin and empagliflozin pooled versus placebo up to Week 26.||||0.8626
72343068|NCT03429543|144210337|OTHER|||||||0.2827|||||||Log Rank|||Time to treatment failure was analysed by Kaplan-Meier estimates up to the end of the study. A log-rank test compared linagliptin and empagliflozin pooled versus placebo up to Week 26.||||0.2827
72343069|NCT03429543|144210338|OTHER||Mean Difference (Final Values)|-5.41||||0.6438|TWO_SIDED|95.0|-28.49|17.67|||ANCOVA||Mean difference calculated as \[Treatment\] - Placebo.|Analysis of covariance (ANCOVA) model with treatment as a fixed classification effect, baseline FPG as linear covariate and age at randomisation as categorical covariate. The random error was assumed to be normally distributed.||17.67|-28.49|0.6438
72343070|NCT03429543|144210338|OTHER||Mean Difference (Final Values)|-35.18||||0.0035|TWO_SIDED|95.0|-58.61|-11.74|||ANCOVA||Mean difference calculated as \[Treatment\] - Placebo.|Analysis of covariance (ANCOVA) model with treatment as a fixed classification effect, baseline FPG as linear covariate and age at randomisation as categorical covariate. The random error was assumed to be normally distributed.||-11.74|-58.61|0.0035
72370074|NCT04173494|144250581|OTHER||Stratified CMH|-8.26||||0.1602|TWO_SIDED|95.0|-20.18|3.66|||Cochran-Mantel-Haenszel|||||3.66|-20.18|0.1602
72370075|NCT04173494|144250582|OTHER||Stratified CMH|19.0||||0.0124|TWO_SIDED|95.0|4.68|33.32|||Cochran-Mantel-Haenszel||\>=1g/dL Increase in Hemoglobin response|||33.32|4.68|0.0124
72343071|NCT03429543|144210338|OTHER||Mean Difference (Final Values)|38.62||||0.031|TWO_SIDED|95.0|4.54|72.7|||ANCOVA||Mean difference calculated as \[Treatment\] - Placebo.|Analysis of covariance (ANCOVA) model with treatment as a fixed classification effect, baseline FPG as linear covariate and age at randomisation as categorical covariate. The random error was assumed to be normally distributed.||72.70|4.54|0.0310
72343072|NCT03429543|144210338|OTHER||Mean Difference (Final Values)|20.05||||0.1994|TWO_SIDED|95.0|-13.01|53.11|||ANCOVA||Mean difference calculated as \[Treatment\] - Placebo.|Analysis of covariance (ANCOVA) model with treatment as a fixed classification effect, baseline FPG as linear covariate and age at randomisation as categorical covariate. The random error was assumed to be normally distributed.||53.11|-13.01|0.1994
72343073|NCT03429543|144210339|OTHER||Mean Difference (Final Values)|1.46||||0.1394|TWO_SIDED|95.0|-0.48|3.41|||Mixed Models Analysis||Mean difference calculated as \[Treatment\] - Placebo.|Mixed model for repeated measures (MMRM) with the fixed categorical effects of treatment, visit, and treatment-by-visit interaction, as well as the categorical covariate age at randomisation and the continuous, fixed covariates of baseline of the response variable and baseline of the response variable-by-visit interaction. The covariate visit was treated as repeated measure with an unstructured covariance structure used to model the within-patient measurements.||3.41|-0.48|0.1394
72343074|NCT03429543|144210339|OTHER||Mean Difference (Final Values)|-0.75||||0.4476|TWO_SIDED|95.0|-2.68|1.19|||Mixed Models Analysis||Mean difference calculated as \[Treatment\] - Placebo.|Mixed model for repeated measures (MMRM) with the fixed categorical effects of treatment, visit, and treatment-by-visit interaction, as well as the categorical covariate age at randomisation and the continuous, fixed covariates of baseline of the response variable and baseline of the response variable-by-visit interaction. The covariate visit was treated as repeated measure with an unstructured covariance structure used to model the within-patient measurements.||1.19|-2.68|0.4476
72343075|NCT03429543|144210339|OTHER||Mean Difference (Final Values)|0.05||||0.9789|TWO_SIDED|95.0|-3.8|3.9|||Mixed Models Analysis||Mean difference calculated as \[Treatment\] - Placebo.|Mixed model for repeated measures (MMRM) with the fixed categorical effects of treatment, visit, and treatment-by-visit interaction, as well as the categorical covariate age at randomisation and the continuous, fixed covariates of baseline of the response variable and baseline of the response variable-by-visit interaction. The covariate visit was treated as repeated measure with an unstructured covariance structure used to model the within-patient measurements.||3.90|-3.80|0.9789
72343076|NCT03429543|144210339|OTHER||Mean Difference (Final Values)|-1.35||||0.5092|TWO_SIDED|95.0|-5.68|2.99|||Mixed Models Analysis||Mean difference calculated as \[Treatment\] - Placebo.|Mixed model for repeated measures (MMRM) with the fixed categorical effects of treatment, visit, and treatment-by-visit interaction, as well as the categorical covariate age at randomisation and the continuous, fixed covariates of baseline of the response variable and baseline of the response variable-by-visit interaction. The covariate visit was treated as repeated measure with an unstructured covariance structure used to model the within-patient measurements.||2.99|-5.68|0.5092
72343077|NCT03429543|144210340|OTHER||Mean Difference (Final Values)|0.91||||0.587|TWO_SIDED|95.0|-2.4|4.22|||Mixed Models Analysis||Mean difference calculated as \[Treatment\] - Placebo.|Mixed model for repeated measures (MMRM) with the fixed categorical effects of treatment, visit, and treatment-by-visit interaction, as well as the categorical covariate age at randomisation and the continuous, fixed covariates of baseline of the response variable and baseline of the response variable-by-visit interaction. The covariate visit was treated as repeated measure with an unstructured covariance structure used to model the within-patient measurements.||4.22|-2.40|0.5870
72343078|NCT03429543|144210340|OTHER||Mean Difference (Final Values)|-1.42||||0.3967|TWO_SIDED|95.0|-4.72|1.88|||Mixed Models Analysis||Mean difference calculated as \[Treatment\] - Placebo.|Mixed model for repeated measures (MMRM) with the fixed categorical effects of treatment, visit, and treatment-by-visit interaction, as well as the categorical covariate age at randomisation and the continuous, fixed covariates of baseline of the response variable and baseline of the response variable-by-visit interaction. The covariate visit was treated as repeated measure with an unstructured covariance structure used to model the within-patient measurements.||1.88|-4.72|0.3967
72343079|NCT03429543|144210340|OTHER||Mean Difference (Final Values)|2.53||||0.5414|TWO_SIDED|95.0|-6.42|11.47|||Mixed Models Analysis||Mean difference calculated as \[Treatment\] - Placebo.|Mixed model for repeated measures (MMRM) with the fixed categorical effects of treatment, visit, and treatment-by-visit interaction, as well as the categorical covariate age at randomisation and the continuous, fixed covariates of baseline of the response variable and baseline of the response variable-by-visit interaction. The covariate visit was treated as repeated measure with an unstructured covariance structure used to model the within-patient measurements.||11.47|-6.42|0.5414
72343080|NCT03429543|144210340|OTHER||Mean Difference (Final Values)|0.0||||0.9995|TWO_SIDED|95.0|-10.13|10.13|||Mixed Models Analysis||Mean difference calculated as \[Treatment\] - Placebo.|Mixed model for repeated measures (MMRM) with the fixed categorical effects of treatment, visit, and treatment-by-visit interaction, as well as the categorical covariate age at randomisation and the continuous, fixed covariates of baseline of the response variable and baseline of the response variable-by-visit interaction. The covariate visit was treated as repeated measure with an unstructured covariance structure used to model the within-patient measurements.||10.13|-10.13|0.9995
72343081|NCT03429543|144210341|OTHER||Mean Difference (Final Values)|1.5||||0.2433|TWO_SIDED|95.0|-1.03|4.02|||Mixed Models Analysis||Mean difference calculated as \[Treatment\] - Placebo.|Mixed model for repeated measures (MMRM) with the fixed categorical effects of treatment, visit, and treatment-by-visit interaction, as well as the categorical covariate age at randomisation and the continuous, fixed covariates of baseline of the response variable and baseline of the response variable-by-visit interaction. The covariate visit was treated as repeated measure with an unstructured covariance structure used to model the within-patient measurements.||4.02|-1.03|0.2433
72343082|NCT03429543|144210341|OTHER||Mean Difference (Final Values)|0.02||||0.9878|TWO_SIDED|95.0|-2.52|2.56|||Mixed Models Analysis||Mean difference calculated as \[Treatment\] - Placebo.|Mixed model for repeated measures (MMRM) with the fixed categorical effects of treatment, visit, and treatment-by-visit interaction, as well as the categorical covariate age at randomisation and the continuous, fixed covariates of baseline of the response variable and baseline of the response variable-by-visit interaction. The covariate visit was treated as repeated measure with an unstructured covariance structure used to model the within-patient measurements.||2.56|-2.52|0.9878
72343083|NCT03429543|144210341|OTHER||Mean Difference (Final Values)|3.33||||0.567|TWO_SIDED|95.0|-9.0|15.65|||Mixed Models Analysis||Mean difference calculated as \[Treatment\] - Placebo.|Mixed model for repeated measures (MMRM) with the fixed categorical effects of treatment, visit, and treatment-by-visit interaction, as well as the categorical covariate age at randomisation and the continuous, fixed covariates of baseline of the response variable and baseline of the response variable-by-visit interaction. The covariate visit was treated as repeated measure with an unstructured covariance structure used to model the within-patient measurements.||15.65|-9.00|0.5670
72343084|NCT03429543|144210341|OTHER||Mean Difference (Final Values)|-6.62||||0.2348|TWO_SIDED|95.0|-18.19|4.95|||Mixed Models Analysis||Mean difference calculated as \[Treatment\] - Placebo.|Mixed model for repeated measures (MMRM) with the fixed categorical effects of treatment, visit, and treatment-by-visit interaction, as well as the categorical covariate age at randomisation and the continuous, fixed covariates of baseline of the response variable and baseline of the response variable-by-visit interaction. The covariate visit was treated as repeated measure with an unstructured covariance structure used to model the within-patient measurements.||4.95|-18.19|0.2348
72343085|NCT03429543|144210342|OTHER||Rate difference (percentage)|6.0||||0.3536|TWO_SIDED|95.0|-7.7|19.9|||Wald test||Difference calculated as \[Treatment\] - Placebo.|The risk difference of active treatments versus placebo was determined and assessed by an exact 2-sided 95% confidence interval. Exact 95% CI by Chan and Zhang. Asymptotic and two-sided Wald test.||19.9|-7.7|0.3536
72343086|NCT03429543|144210342|OTHER||Rate difference (percentage)|11.7||||0.0914|TWO_SIDED|95.0|-2.4|26.3|||Wald test||Difference calculated as \[Treatment\] - Placebo.|The risk difference of active treatments versus placebo was determined and assessed by an exact 2-sided 95% confidence interval. Exact 95% CI by Chan and Zhang. Asymptotic and two-sided Wald test.||26.3|-2.4|0.0914
72343087|NCT03429543|144210342|OTHER||Rate difference (percentage)|-23.3||||0.5455|TWO_SIDED|90.0|-67.9|27.1|||Fisher Exact||Difference calculated as \[Treatment\] - Placebo.|The risk difference of active treatments versus placebo was determined and assessed by an exact 2-sided 95% confidence interval. Exact 95% CI by Chan and Zhang. Asymptotic and Fisher's exact test.||27.1|-67.9|0.5455
72343088|NCT03429543|144210342|OTHER||Rate difference (percentage)|-23.3||||0.5455|TWO_SIDED|90.0|-67.9|27.1|||Fisher Exact||Difference calculated as \[Treatment\] - Placebo.|The risk difference of active treatments versus placebo was determined and assessed by an exact 2-sided 95% confidence interval. Exact 95% CI by Chan and Zhang. Asymptotic and Fisher's exact test.||27.1|-67.9|0.5455
72343089|NCT03429543|144210343|OTHER||Rate difference (percentage)|2.4||||0.7789|TWO_SIDED|95.0|-15.2|19.5|||Wald test||Difference calculated as \[Treatment\] - Placebo.|The risk difference of active treatments versus placebo was determined and assessed by an exact 2-sided 95% confidence interval. Exact 95% CI by Chan and Zhang. Asymptotic and two-sided Wald test.||19.5|-15.2|0.7789
72343090|NCT03429543|144210343|OTHER||Rate difference (percentage)|10.1||||0.2548|TWO_SIDED|95.0|-7.7|28.1|||Wald test||Difference calculated as \[Treatment\] - Placebo.|The risk difference of active treatments versus placebo was determined and assessed by an exact 2-sided 95% confidence interval. Exact 95% CI by Chan and Zhang. Asymptotic and two-sided Wald test.||28.1|-7.7|0.2548
72343091|NCT03429543|144210343|OTHER||Rate difference (percentage)|-23.3||||0.5455|TWO_SIDED|90.0|-67.9|27.1|||Fisher Exact||Difference calculated as \[Treatment\] - Placebo.|The risk difference of active treatments versus placebo was determined and assessed by an exact 2-sided 95% confidence interval. Exact 95% CI by Chan and Zhang. Asymptotic and Fisher's exact test.||27.1|-67.9|0.5455
72343092|NCT03429543|144210343|OTHER||Rate difference (percentage)|26.7||||0.5671|TWO_SIDED|90.0|-30.8|70.8|||Fisher Exact||Difference calculated as \[Treatment\] - Placebo.|The risk difference of active treatments versus placebo was determined and assessed by an exact 2-sided 95% confidence interval. Exact 95% CI by Chan and Zhang. Asymptotic and Fisher's exact test.||70.8|-30.8|0.5671
72343093|NCT01818492|144210344|SUPERIORITY|||||||0.0134|||||||Exact binomial test|This test was undertaken at the one-sided 0.025 significance level.||Pre-specified null hypothesis that ORR is at most 40%.||||0.0134
72343094|NCT01818492|144210345|SUPERIORITY|||||||0.0031|||||||Exact binomial test|This test was undertaken at the one-sided 0.025 significance level.||Pre-specified null hypothesis that ORR is at most 40%||||0.0031
72343095|NCT01818492|144210346|SUPERIORITY|||||||0.0205|||||||Exact binomial test|This test was undertaken at the one-sided 0.025 significance level.||Pre-specified null hypothesis that ORR is at most 40%||||0.0205
72343096|NCT01818492|144210347|SUPERIORITY|||||||0.0053|||||||Exact binomial test|This test was undertaken at the one-sided 0.025 significance level.||Pre-specified null hypothesis that ORR is at most 40%.||||0.0053
72343097|NCT03249103|144210368|OTHER|||||||0.032|||||||t-test, 2 sided|||placebo - NYX-2925 20 mg||||0.032
72343098|NCT03249103|144210369|OTHER|||||||0.039|||||||t-test, 2 sided|||placebo - NYX-2925 200 mg||||0.039
72343099|NCT03249103|144210370|OTHER|||||||0.0072|||||||t-test, 2 sided|comparing Week 2 (Placebo) to Week 6 (NYX-2925 200 mg)||||||0.0072
72343100|NCT02428413|144210371|SUPERIORITY_OR_OTHER|||||||0.24|||||||t-test, 2 sided|||||||0.24
72343101|NCT02428413|144210372|SUPERIORITY_OR_OTHER|||||||0.26|||||||t-test, 2 sided|||||||0.26
72343102|NCT02025439|144210375|OTHER||Mean Difference (Final Values)|0.071|||<|0.05|TWO_SIDED||||||t-test, 2 sided|||||||<0.05
72343103|NCT01786252|144210383|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|Sidak-multiple comparison test was performed to detect significant differences between groups.||Statistical analysis to compare differences between endometrial glandular and stromal dating within the vehicle group.||||<0.05
72343104|NCT01786252|144210383|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|Sidak-multiple comparison test was performed to detect significant differences between groups.||Statistical analysis to compare differences between endometrial glandular and stromal dating within the hCG group.||||>0.05
72343105|NCT01786252|144210383|SUPERIORITY_OR_OTHER||||||<|0.01|||||||ANOVA|Sidak-multiple comparison test was performed to detect significant differences between groups.||Statistical analysis to compare stromal staging between hCG and IVF media group.||||<0.01
72343106|NCT01786252|144210383|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|Sidak-multiple comparison test was performed to detect significant differences between groups.||Statistical analysis to compare differences between endometrial glandular dating between hCG and IVF media groups.||||>0.05
72343107|NCT01786252|144210384|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
72343108|NCT01786252|144210385|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
72343109|NCT01786252|144210386|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
72343110|NCT03688100|144210391|SUPERIORITY||ratio of means|0.62||||0.005|TWO_SIDED|95.0|0.45|0.86||The a priori threshold for statistical significance is p\<0.05.|Zero Inflated Poisson (ZIP) Model||For the ratio of means, BA is the numerator and MEDS is the denominator.|Emergency Department visits AT 3 MONTHS||0.86|0.45|0.005
72343111|NCT03688100|144210391|SUPERIORITY||ratio of means|0.7||||0.008|TWO_SIDED|95.0|0.6|0.86||The a priori threshold for statistical significance is p\<0.05|Zero Inflated Poisson (ZIP) Model||For the ratio of means for ED visits, BA is the numerator and MEDS is the denominator.|Emergency Department visits AT 6 MONTHS||0.86|0.60|0.008
72343112|NCT03688100|144210391|SUPERIORITY||ratio of means|0.73||||0.0001|TWO_SIDED|95.0|0.62|0.85||The a priori threshold for statistical significance is p\<0.05.|Zero Inflated Poisson (ZIP) Model||For the ratio of means for ED visits , BA is numerator and MEDS is the denominator.|Emergency Department visits AT 12 MONTHS||0.85|0.62|0.0001
72343113|NCT03688100|144210392|SUPERIORITY||||||>|0.05||||||The a priori threshold for statistical significance is p\<0.05.|Zero Inflated Poisson (ZIP) Model|||Differences in the number of hospital readmissions between BA and MEDS at 3, 6, and 12 months||||>0.05
72343114|NCT03688100|144210393|SUPERIORITY||ratio of means|0.83||||0.002|TWO_SIDED|95.0|0.75|0.92||The a priori threshold for statistical significance is p\<0.05.|Zero Inflated Poisson (ZIP) Model||For the ratio of means, BA is the numerator and MEDS is the denominator.|Days in the Hospital at 3 months||0.92|0.75|0.002
72343115|NCT03688100|144210393|SUPERIORITY||ratio of means|0.81||||0.005|TWO_SIDED|95.0|0.75|0.87||The a priori threshold for statistical significance is p\<0.05.|Zero Inflated Poisson (ZIP) Model||For the ratio of means, BA is numerator and MEDS is the denominator.|Days in the Hospital at 6 MONTHS||0.87|0.75|0.005
72343116|NCT03688100|144210393|SUPERIORITY||ratio of means|0.64|||<|0.0001|TWO_SIDED|95.0|0.6|0.68||The a priori threshold for statistical significance is p\<0.05.|Zero Inflated Poisson (ZIP) Model||For the ratio of means, BA is the numerator and MEDS is the denominator.|Days in the Hospital AT 12 MONTHS||0.68|0.60|<0.0001
72343117|NCT03688100|144210394|SUPERIORITY||||||>|0.05||||||The a priori threshold for statistical significance is p\<0.05.|Kaplan Meier survival plots|||||||>0.05
72343118|NCT00651625|144210417|SUPERIORITY_OR_OTHER||non-applicable|||||0.05|TWO_SIDED||||||t-test, 2 sided|||group comparisons using t-test and confidence intervals.||||0.05
72343119|NCT01300260|144210439|SUPERIORITY_OR_OTHER||Geometric least squares (LS) mean ratio|2.96|||<|0.001|TWO_SIDED|95.0|2.41|3.64||P-value is two-sided.|Mixed Models Analysis|The mixed model analysis included treatment, period, and sequence as fixed effects and participant nested in sequence as a random effect.||||3.64|2.41|<0.001
72343120|NCT01300260|144210439|SUPERIORITY_OR_OTHER||Geometric least squares (LS) means ratio|5.4|||<|0.001|TWO_SIDED|95.0|4.09|7.13||P-value is two-sided.|Mixed Models Analysis|The mixed model analysis included treatment, period, and sequence as fixed effects and participant nested in sequence as a random effect.||||7.13|4.09|<0.001
72343121|NCT01300260|144210440|SUPERIORITY_OR_OTHER||Geometric least squares (LS) mean ratio|3.09|||<|0.001|TWO_SIDED|95.0|2.66|3.59||P-value is two-sided.|Mixed Models Analysis|The mixed model analysis included treatment, period, and sequence as fixed effects and participant nested in sequence as a random effect.||||3.59|2.66|<0.001
72343122|NCT01300260|144210440|SUPERIORITY_OR_OTHER||Geometric least squares (LS) mean ratio|7.92|||<|0.001|TWO_SIDED|95.0|4.82|13.0||P-value is two-sided.|Mixed Models Analysis|The mixed model analysis included treatment, period, and sequence as fixed effects and participant nested in sequence as a random effect.||||13.0|4.82|<0.001
72343123|NCT01300260|144210441|SUPERIORITY_OR_OTHER||Geometric least squares (LS) mean ratio|4.15|||<|0.001|TWO_SIDED|95.0|3.45|5.0||P-value is two-sided.|Mixed Models Analysis|The mixed model analysis included treatment, period, and sequence as fixed effects and participant nested in sequence as a random effect.||||5.00|3.45|<0.001
72343124|NCT01300260|144210441|SUPERIORITY_OR_OTHER||Geometric least squares (LS) mean ratio|3.78|||<|0.001|TWO_SIDED|95.0|2.99|4.78||P-value is two-sided.|Mixed Models Analysis|The mixed model analysis included treatment, period, and sequence as fixed effects and participant nested in sequence as a random effect.||||4.78|2.99|<0.001
72343125|NCT01300260|144210442|SUPERIORITY_OR_OTHER||Geometric least squares (LS) mean ratio|2.04||||0.011|TWO_SIDED|95.0|1.26|3.31||P-value is two-sided.|Mixed Models Analysis|The mixed model analysis included treatment, period, and sequence as fixed effects and participant nested in sequence as a random effect.||||3.31|1.26|0.011
72343126|NCT01300260|144210442|SUPERIORITY_OR_OTHER||Geometric least squares (LS) mean ratio|2.44|||<|0.001|TWO_SIDED|95.0|1.71|3.47||P-value is two-sided.|Mixed Models Analysis|The mixed model analysis included treatment, period, and sequence as fixed effects and participant nested in sequence as a random effect.||||3.47|1.71|<0.001
72343127|NCT01300260|144210443|SUPERIORITY_OR_OTHER||Geometric least squares (LS) mean ratio|1.22||||0.021|TWO_SIDED|95.0|1.04|1.43||P-value is two-sided.|Mixed Models Analysis|The mixed model analysis included treatment, period, and sequence as fixed effects and participant nested in sequence as a random effect.||||1.43|1.04|0.021
72343128|NCT01300260|144210443|SUPERIORITY_OR_OTHER||Geometric least squares (LS) mean ratio|1.39|||<|0.001|TWO_SIDED|95.0|1.27|1.53||P-value is two-sided.|Mixed Models Analysis|The mixed model analysis included treatment, period, and sequence as fixed effects and participant nested in sequence as a random effect.||||1.53|1.27|<0.001
72343129|NCT01300260|144210444|SUPERIORITY_OR_OTHER||Geometric least squares (LS) mean ratio|1.43||||0.009|TWO_SIDED|95.0|1.14|1.8||P-value is two-sided.|Mixed Models Analysis|The mixed model analysis included treatment, period, and sequence as fixed effects and participant nested in sequence as a random effect.||||1.80|1.14|0.009
72343130|NCT01300260|144210444|SUPERIORITY_OR_OTHER||Geometric least squares (LS) mean ratio|1.75|||<|0.001|TWO_SIDED|95.0|1.59|1.94||P-value is 2-sided.|Mixed Models Analysis|The mixed model analysis included treatment, period, and sequence as fixed effects and participant nested in sequence as a random effect.||||1.94|1.59|<0.001
72343131|NCT00377364|144210446|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||ANCOVA|||Baseline RAVLT scores used as covariate.||||<0.05
72343132|NCT00377364|144210449|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||ANCOVA|Baseline ISS scores used as a covariate. ANCOVA results were not significant.||||||<0.05
72343133|NCT00377364|144210450|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||ANCOVA|||Baseline HRSD scores used as a covariate.||||<0.05
72343134|NCT00377364|144210452|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|Baseline YMRS scores used as a covariate.||||||0.05
72343135|NCT00377364|144210454|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||ANCOVA|Baseline ACQ scores used as a covariate.||||||<0.05
72343136|NCT00439374|144210461|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.03|||||TWO_SIDED|95.0|0.79|1.35||||||All deliveries less than 37 weeks||1.35|0.79|
72343137|NCT00439374|144210461|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.99|||||TWO_SIDED|95.0|0.7|1.4||||||Spontaneous deliveries||1.40|0.70|
72343138|NCT00439374|144210461|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.09|||||TWO_SIDED|95.0|0.65|1.84||||||Medically-indicated deliveries||1.84|0.65|
72343139|NCT00439374|144210462|SUPERIORITY_OR_OTHER|||||||0.93|||||||Wilcoxon (Mann-Whitney)|||||||0.93
72343140|NCT00439374|144210463|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.05|||||TWO_SIDED|95.0|0.61|1.8||||||||1.80|0.61|
72343141|NCT00439374|144210464|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.84|||||TWO_SIDED|95.0|0.58|1.21||||||||1.21|0.58|
72343142|NCT00439374|144210465|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.88|||||TWO_SIDED|95.0|0.54|1.43||||||||1.43|0.54|
72343143|NCT00439374|144210466|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.69|||||TWO_SIDED|95.0|0.36|1.3||||||||1.30|0.36|
72343144|NCT00439374|144210467|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.97|||||TWO_SIDED|95.0|0.82|1.15||||||||1.15|0.82|
72343145|NCT00439374|144210468|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.84|||||TWO_SIDED|95.0|0.55|1.29||||||||1.29|0.55|
72343146|NCT00439374|144210469|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.09|||||TWO_SIDED|95.0|0.77|1.55||||||||1.55|0.77|
72343147|NCT00439374|144210470|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.52|||||TWO_SIDED|95.0|0.43|5.33||||||||5.33|0.43|
72343148|NCT00439374|144210471|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.16|||||TWO_SIDED|95.0|0.78|1.72||||||||1.72|0.78|
72343149|NCT00439374|144210472|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.16|||||TWO_SIDED|95.0|0.56|2.41||||||||2.41|0.56|
72343150|NCT00439374|144210474|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.74|||||TWO_SIDED|95.0|0.34|1.58||||||||1.58|0.34|
72343151|NCT00439374|144210475|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.45|||||TWO_SIDED|95.0|0.84|2.52||||||||2.52|0.84|
72343152|NCT00439374|144210476|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.07|||||TWO_SIDED|95.0|0.79|1.46||||||||1.46|0.79|
72343153|NCT00439374|144210477|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.02|||||TWO_SIDED|95.0|0.92|1.13||||||Any side effect||1.13|0.92|
72343154|NCT00439374|144210477|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.04|||||TWO_SIDED|95.0|0.93|1.17||||||Injection site||1.17|0.93|
72343155|NCT00439374|144210477|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|5.03|||||TWO_SIDED|95.0|1.11|22.78||||||Urticaria||22.78|1.11|
72343156|NCT00439374|144210477|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.7|||||TWO_SIDED|95.0|0.27|1.83||||||Nausea||1.83|0.27|
72343157|NCT00439374|144210478|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.77|||||TWO_SIDED|95.0|0.46|1.3||||||Analysis is for the total composite||1.30|0.46|
72343158|NCT00439374|144210479|SUPERIORITY_OR_OTHER|||||||0.82|||||||Wilcoxon (Mann-Whitney)|||||||0.82
72343159|NCT00439374|144210487|SUPERIORITY_OR_OTHER|||||||0.61|||||||Wilcoxon (Mann-Whitney)|||||||0.61
72343160|NCT02540265|144210489|OTHER||Effect Size|1.01|||||TWO_SIDED|||||||||||||
72343161|NCT02540265|144210489|OTHER||Effect Size|0.87|||||TWO_SIDED|||||||||||||
72343162|NCT02540265|144210490|SUPERIORITY|||||||0.0049|||||||t-test, 2 sided|||||||0.0049
72343163|NCT02540265|144210490|SUPERIORITY|||||||0.0076|||||||t-test, 2 sided|||||||0.0076
72343164|NCT02540265|144210491|SUPERIORITY||||||<|0.05||||||Applies to SPID 0-6, SPID 0-12, SPID 0-24, SPID 12-24, SPID 12-48, and SPID 24-48|t-test, 2 sided|||||||<0.05
72343165|NCT02540265|144210491|SUPERIORITY||||||<|0.05||||||Applies to SPID 0-6, SPID 0-12, SPID 0-24, SPID 12-24, SPID 12-48, and SPID 24-48|t-test, 2 sided|||||||<0.05
72343166|NCT02102399|144210512|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED||||||Wilcoxon's signed-rank test|||||||0.001
72343167|NCT02102399|144210513|SUPERIORITY_OR_OTHER|||||||0.345|TWO_SIDED||||||Wilcoxon's signed-rank test|||||||0.345
72343168|NCT02102399|144210514|SUPERIORITY_OR_OTHER|||||||0.003|TWO_SIDED||||||Fisher Exact|||||||0.003
72343169|NCT02102399|144210515|SUPERIORITY_OR_OTHER|||||||0.171|TWO_SIDED||||||Wilcoxon's signed-rank test|||||||0.171
72343170|NCT02102399|144210516|SUPERIORITY_OR_OTHER|||||||0.022|TWO_SIDED||||||Wilcoxon's signed-rank test|||||||0.022
72343171|NCT02102399|144210517|SUPERIORITY_OR_OTHER|||||||0.451|TWO_SIDED||||||Wilcoxon's signed-rank test|||||||0.451
72343172|NCT02102399|144210518|SUPERIORITY_OR_OTHER|||||||0.477|TWO_SIDED||||||Wilcoxon's signed-rank test|||||||0.477
72343173|NCT02102399|144210519|SUPERIORITY_OR_OTHER|||||||0.007|TWO_SIDED||||||Wilcoxon's signed-rank test|||||||0.007
72343174|NCT02102399|144210520|SUPERIORITY_OR_OTHER|||||||0.049|TWO_SIDED||||||Wilcoxon's signed-rank test|||||||0.049
72343175|NCT02102399|144210521|SUPERIORITY_OR_OTHER|||||||0.323|TWO_SIDED||||||Wilcoxon's signed-rank test|||||||0.323
72343176|NCT02102399|144210522|SUPERIORITY_OR_OTHER|||||||0.296|TWO_SIDED||||||Wilcoxon's signed-rank test|||||||0.296
72343177|NCT02102399|144210523|SUPERIORITY_OR_OTHER|||||||0.776|TWO_SIDED||||||Wilcoxon's signed-rank test|||||||0.776
72343178|NCT02102399|144210524|SUPERIORITY_OR_OTHER|||||||0.959|TWO_SIDED||||||Wilcoxon's signed-rank test|||||||0.959
72343179|NCT02102399|144210525|SUPERIORITY_OR_OTHER|||||||0.76|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.76
72343180|NCT02102399|144210526|SUPERIORITY_OR_OTHER|||||||0.3|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.30
72343181|NCT02102399|144210527|SUPERIORITY_OR_OTHER|||||||0.2|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.20
72343182|NCT02102399|144210528|SUPERIORITY_OR_OTHER|||||||0.77|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.77
72343183|NCT02102399|144210529|SUPERIORITY_OR_OTHER|||||||0.49|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.49
72343184|NCT02102399|144210530|SUPERIORITY_OR_OTHER|||||||0.74|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.74
72343185|NCT02102399|144210531|SUPERIORITY_OR_OTHER|||||||0.12|TWO_SIDED||||||Fisher Exact|||||||0.120
72343186|NCT02102399|144210532|SUPERIORITY_OR_OTHER|||||||0.03|TWO_SIDED||||||Fisher Exact|||||||0.030
72343187|NCT02102399|144210533|SUPERIORITY_OR_OTHER|||||||0.107|TWO_SIDED||||||Fisher Exact|||||||0.107
72343188|NCT03101085|144210534|OTHER|We performed a paired T-test analysis to ascertain whether the COX/CS activity while on S-equol was comparable or different than the COX/CS while on placebo. For each participant, the COX/CS value while on S-equol was subtracted from their COX/CS value while on placebo.|||||>|0.05|||||||Paired T-test|||As the order of the intervention does not matter, all 39 participants who contributed data to the final analysis are included together.||||>0.05
72343189|NCT04583956|144210559|SUPERIORITY||Odds Ratio (OR)|0.98||||0.927|TWO_SIDED|95.0|0.59|1.61|||Proportional odds model||Odds ratio above 1 favors Remdesivir plus Risankizumab.|Includes all ordinal score categories. Odds ratio of a better clinical status score, confidence interval, and p-value estimated from a proportional odds model adjusted for baseline steroid use and baseline ordinal score. Missing data imputed using multiple imputation (MI) for participants lost to follow-up before Day 8 while hospitalized, in hospice, long term acute care, or transferred to other hospital while participants lost to follow-up after discharge to home are assigned a score of 2.||1.61|0.59|0.927
72343190|NCT04583956|144210560|SUPERIORITY||Odds Ratio (OR)|0.9||||0.829|TWO_SIDED|95.0|0.36|2.25|||Regression, Logistic||Odds ratio greater than 1 favors Remdesivir plus Risankizumab.|Odds ratio, confidence interval, and p-value estimated from a logistic regression model adjusted for baseline dexamethasone use, baseline ordinal score, age, and baseline C-Reactive Protein (CRP).||2.25|0.36|0.829
72343191|NCT04583956|144210561|SUPERIORITY||Hazard Ratio (HR)|1.14||||0.399|TWO_SIDED|95.0|0.84|1.56|||Regression, Cox||HR greater than 1 favors Remdesivir plus Risankizumab.|Hazard ratio, confidence interval, and p-value estimated from a Cox model adjusted for baseline steroid use and baseline ordinal score.||1.56|0.84|0.399
72343192|NCT04583956|144210562|SUPERIORITY||Odds Ratio (OR)|1.03||||0.91|TWO_SIDED|95.0|0.62|1.71|||Proportional odds model||Odds ratio above 1 favors Remdesivir plus Risankizumab.|Includes all ordinal score categories. Odds ratio of a better clinical status score, confidence interval, and p-value estimated from a proportional odds model adjusted for baseline steroid use and baseline ordinal score. Missing data imputed using last observation carried forward for those lost to follow-up before Day 15 while hospitalized, in hospice, long term acute care, or transferred to other hospital. Participants lost to follow-up before Day 15 after discharge are given a score of 2.||1.71|0.62|0.910
72343193|NCT04583956|144210563|SUPERIORITY||Odds Ratio (OR)|1.14||||0.617|TWO_SIDED|95.0|0.68|1.93|||Proportional odds model||Odds ratio above 1 favors Remdesivir plus Risankizumab.|Includes all ordinal score categories. Odds ratio of a better clinical status score, confidence interval, and p-value estimated from a proportional odds model adjusted for baseline steroid use and baseline ordinal score. Missing data imputed using last observation carried forward for those lost to follow-up before Day 15 while hospitalized, in hospice, long term acute care, or transferred to other hospital. Participants lost to follow-up before Day 15 after discharge are given a score of 2.||1.93|0.68|0.617
72343194|NCT04583956|144210596|SUPERIORITY||Hazard Ratio (HR)|1.09||||0.55|TWO_SIDED|95.0|0.82|1.46|||Regression, Cox||HR greater than 1 favors Remdesivir plus Risankizumab.|Hazard ratio (HR), confidence interval, and p-value estimated from a Cox model adjusted for baseline steroid use and baseline ordinal score.||1.46|0.82|0.550
72343195|NCT04583956|144210597|SUPERIORITY||Hazard Ratio (HR)|1.1||||0.523|TWO_SIDED|95.0|0.82|1.48|||Regression, Cox||HR greater than 1 favors Remdesivir plus Risankizumab.|Hazard ratio (HR), confidence interval, and p-value estimated from a Cox model adjusted for baseline steroid use and baseline ordinal score.||1.48|0.82|0.523
72343196|NCT04016077|144210600|OTHER|The ratio and 90% confidence interval were expressed as percentages.|Ratio of Geometric Means|118.5|||||TWO_SIDED|90.0|87.96|159.64|||ANOVA|||||159.64|87.96|
72343197|NCT04016077|144210601|OTHER|The ratio and 90% confidence interval were expressed as percentages.|Ratio of Geometric Means|104.0|||||TWO_SIDED|90.0|74.48|145.23|||ANOVA|||||145.23|74.48|
72343198|NCT02100475|144210610|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3||||0.427|TWO_SIDED|95.0|-1.05|0.46|||ANCOVA|||The response and change from baseline in the response after 26 weeks of treatment was analysed using an analysis of covariance (ANCOVA) method with treatment and baseline IDegLira dose strata as fixed factors and baseline response as a covariate. Missing data were imputed using LOCF.||0.46|-1.05|0.427
72343199|NCT00757822|144210616|SUPERIORITY_OR_OTHER||Difference in Percentages|4.6|||>|0.76|TWO_SIDED|90.0|-9.5|18.6|||Fisher Exact|||The incidence of PON per arm will be determined and expressed as a percentage of the total patients per arm. Treatment efficacy will be measured as the percentage-point decrease in PON in the treatment arm (Marinol) compared to the standard therapy arm (ondansetron). Null hypothesis: Marinol treatment is not superior to ondansetron treatment. We will test the statistical significance with Fisher's Exact test at a significance level of 0.05||18.6|-9.5|>0.76
72343200|NCT00757822|144210617|SUPERIORITY_OR_OTHER||||||>|0.92|||||||Fisher Exact|One-sided Fisher's Exact test was performed comparing the percentage of subjects with at least one VAS score \> 0. (Marinol\>Ondansetron).||||||>0.92
72343201|NCT00757822|144210618|SUPERIORITY_OR_OTHER||Difference in Percentages|7.7|||>|0.55|TWO_SIDED|90.0|-12.1|13.3|||Fisher Exact|||||13.3|-12.1|>0.55
72343202|NCT00757822|144210619|SUPERIORITY_OR_OTHER||||||=|0.981|TWO_SIDED||||||Wilcoxon Rank-Sum test|||||||=0.981
72343203|NCT00757822|144210620|SUPERIORITY_OR_OTHER||||||>|0.9|||||||Fisher Exact|||||||>0.90
72343204|NCT00757822|144210621|SUPERIORITY_OR_OTHER||||||>|0.37|TWO_SIDED||||||Fisher Exact|||||||>0.37
72343205|NCT00757822|144210622|SUPERIORITY_OR_OTHER||||||>|0.75|TWO_SIDED||||||FREQ Procedure|||Comparisons at 24-48 hr post-surgery. Null hypothesis: dronabinol is not superior to ondansetron in patient satisfaction.||||>0.75
72343206|NCT00757822|144210622|SUPERIORITY_OR_OTHER||||||>|0.1|TWO_SIDED||||||FREQ procedure|||Comparisons of both arms at 2-6 weeks; null hypothesis: dronabinol is not superior to ondansetron in patient satisfaction||||>0.10
72343207|NCT00757822|144210623|SUPERIORITY_OR_OTHER||||||>|0.29|TWO_SIDED||||||FREQ procedure|||Comparison of both group responses at 24-48 hours.||||>0.29
72343208|NCT00757822|144210623|SUPERIORITY_OR_OTHER||||||>|0.55|TWO_SIDED||||||FREQ Procedure|||Comparisons of both arms at 2-6 weeks.||||>0.55
72343209|NCT02814175|144210633|OTHER|Between group difference|point estimate difference|28.3|||<|0.001|TWO_SIDED|95.0|17.8|38.9|||Cochran-Mantel-Haenszel|Adjusted for the stratification factor which is the duration of prior MTX 15 mg ew use of ≤ 3 months or \> 3 months.||||38.9|17.8|< 0.001
72343210|NCT01597635|144210679|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.17||||1|TWO_SIDED|95.0|0.083|0.359|||Bayesian repeated measures model|||AngII, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 0.5 hours||0.359|0.083|1.000
72343211|NCT01597635|144210679|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.23||||0.9999|TWO_SIDED|95.0|0.111|0.492|||Bayesian repeated measures model|||AngII, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 2 hours||0.492|0.111|0.9999
72343212|NCT01597635|144210679|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.26||||0.9997|TWO_SIDED|95.0|0.121|0.568|||Bayesian repeated measures model|||AngII, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 6 hours||0.568|0.121|0.9997
72343213|NCT01597635|144210679|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.31||||0.9997|TWO_SIDED|95.0|0.136|0.66|||Bayesian repeated measures model|||AngII, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 12 hours||0.660|0.136|0.9997
72343214|NCT01597635|144210679|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.29||||0.9991|TWO_SIDED|95.0|0.133|0.632|||Bayesian repeated measures model|||AngII, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 24 hours||0.632|0.133|0.9991
72343215|NCT01597635|144210679|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.46||||0.9631|TWO_SIDED|95.0|0.213|1.081|||Bayesian repeated measures model|||AngII, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 48 hours||1.081|0.213|0.9631
72343216|NCT01597635|144210679|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.33||||0.9941||95.0|0.157|0.789|||Bayesian repeated measures model|||AngII, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 48.5 hours||0.789|0.157|0.9941
72343217|NCT01597635|144210679|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.38||||0.9875|TWO_SIDED|95.0|0.179|0.891|||Bayesian repeated measures model|||AngII, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 50 hours||0.891|0.179|0.9875
72343218|NCT01597635|144210679|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.33||||0.9956|TWO_SIDED|95.0|0.151|0.759|||Bayesian repeated measures model|||AngII, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 54 hours||0.759|0.151|0.9956
72343219|NCT01597635|144210679|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.34||||0.9964|TWO_SIDED|95.0|0.157|0.747|||Bayesian repeated measures model|||AngII, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 60 hours||0.747|0.157|0.9964
72343220|NCT01597635|144210679|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.25||||0.9999|TWO_SIDED|95.0|0.114|0.532|||Bayesian repeated measures model|||AngII, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 66 hours||0.532|0.114|0.9999
72343221|NCT01597635|144210679|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.29||||0.9991|TWO_SIDED|95.0|0.13|0.647|||Bayesian repeated measures model|||AngII, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 72 hours||0.647|0.130|0.9991
72343222|NCT01597635|144210679|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.36||||0.9852|TWO_SIDED|0.9852|0.137|0.906|||Bayesian repeated measures model|||AngII, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 96 hours||0.906|0.137|0.9852
72343223|NCT01597635|144210679|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.51||||0.9719|TWO_SIDED|95.0|0.23|1.014|||Bayesian repeated measures model|||AngII, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 120 hours||1.014|0.230|0.9719
72343224|NCT01597635|144210679|SUPERIORITY||Ratio of Active/Placebo|3.98||||1|TWO_SIDED|95.0|2.263|6.919|||Bayesian repeated measures model|||Ang1-5 , Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 0.5 hours||6.919|2.263|1.0000
72343225|NCT01597635|144210679|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|3.46||||1|TWO_SIDED|95.0|1.976|6.052|||Bayesian repeated measures model|||Ang1-5 , Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 2 hours||6.052|1.976|1.000
72343226|NCT01597635|144210679|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|3.59||||1|TWO_SIDED|95.0|2.06|6.345|||Bayesian repeated measures model|||Ang1-5 , Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 6 hours||6.345|2.060|1.0000
72343227|NCT01597635|144210679|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.82||||0.9806|TWO_SIDED|95.0|1.031|3.17|||Bayesian repeated measures model|||Ang1-5 , Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 12 hours||3.170|1.031|0.9806
72343228|NCT01597635|144210679|SUPERIORITY||Ratio of Active/Placebo|1.5||||0.9129|TWO_SIDED|95.0|0.828|2.636|||Bayesian repeated measures model|||Ang1-5 , Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 24 hours||2.636|0.828|0.9129
72343229|NCT01597635|144210679|SUPERIORITY||Ratio of Active/Placebo|1.92||||0.9891|TWO_SIDED|95.0|1.098|3.349|||Bayesian repeated measures model|||Ang1-5 , Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 48 hours||3.349|1.098|0.9891
72343230|NCT01597635|144210679|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|2.29||||0.9983|TWO_SIDED|95.0|1.316|3.974|||Bayesian repeated measures model|||Ang1-5 , Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 48.5 hours||3.974|1.316|0.9983
72343231|NCT01597635|144210679|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.94||||0.99|TWO_SIDED|95.0|1.112|3.359|||Bayesian repeated measures model|||Ang1-5 , Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 50 hours||3.359|1.112|0.9900
72343232|NCT01597635|144210679|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.27||||0.7996|TWO_SIDED|95.0|0.729|2.163|||Bayesian repeated measures model|||Ang1-5 , Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 54 hours||2.163|0.729|0.7996
72343233|NCT01597635|144210679|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.23||||0.7778|TWO_SIDED|95.0|0.718|2.087|||Bayesian repeated measures model|||Ang1-5 , Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 60 hours||2.087|0.718|0.7778
72343234|NCT01597635|144210679|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.24||||0.773|TWO_SIDED|95.0|0.705|2.113|||Bayesian repeated measures model|||Ang1-5 , Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 66 hours||2.113|0.705|0.7730
72343235|NCT01597635|144210679|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.45||||0.8951|TWO_SIDED|95.0|0.814|2.604|||Bayesian repeated measures model|||Ang1-5 , Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 72 hours||2.604|0.814|0.8951
72343236|NCT01597635|144210679|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.57||||0.9324|TWO_SIDED|95.0|0.276|1.183|||Bayesian repeated measures model|||Ang1-5 , Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 96 hours||1.183|0.276|0.9324
72343237|NCT01597635|144210679|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.63||||0.8982|TWO_SIDED|95.0|0.351|1.257|||Bayesian repeated measures model|||Ang1-5 , Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 120 hours||1.257|0.351|0.8982
72343238|NCT01597635|144210679|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|4.22||||0.9998|TWO_SIDED|95.0|1.91|8.905|||Bayesian repeated measures model|||Ang1-7 , Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 0.5 hours||8.905|1.910|0.9998
72343239|NCT01597635|144210679|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|3.67||||0.9993|TWO_SIDED|95.0|1.689|7.97|||Bayesian repeated measures model|||Ang1-7 , Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 2 hours||7.970|1.689|0.9993
72343240|NCT01597635|144210679|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|5.26||||1|TWO_SIDED|95.0|2.392|11.754|||Bayesian repeated measures model|||Ang1-7 , Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 6 hours||11.754|2.392|1.0000
72343241|NCT01597635|144210679|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|2.25||||0.9713|TWO_SIDED|95.0|0.972|5.136|||Bayesian repeated measures model|||Ang1-7 , Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 12 hours||5.136|0.972|0.9713
72343242|NCT01597635|144210679|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|2.19||||0.9649|TWO_SIDED|95.0|0.94|4.975|||Bayesian repeated measures model|||Ang1-7 , Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 24 hours||4.975|0.940|0.9649
72343243|NCT01597635|144210679|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.59||||0.8749|TWO_SIDED|95.0|0.711|3.473|||Mixed Models Analysis|||Ang1-7 , Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 48 hours||3.473|0.711|0.8749
72343244|NCT01597635|144210679|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.99||||0.9566|TWO_SIDED|95.0|0.899|4.342|||Bayesian repeated measures model|||Ang1-7 , Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 48.5 hours||4.342|0.899|0.9566
72343245|NCT01597635|144210679|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.91||||0.9549|TWO_SIDED|95.0|0.862|4.173|||Bayesian repeated measures model|||Ang1-7 , Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 50 hours||4.173|0.862|0.9549
72343246|NCT01597635|144210679|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.81||||0.9275|TWO_SIDED|95.0|0.816|4.005|||Bayesian repeated measures model|||Ang1-7 , Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 54 hours||4.005|0.816|0.9275
72343247|NCT01597635|144210679|SUPERIORITY||Ratio of Active/Placebo|1.32||||0.7483|TWO_SIDED|95.0|0.584|3.007|||Bayesian repeated measures model|||Ang1-7 , Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 60 hours||3.007|0.584|0.7483
72343248|NCT01597635|144210679|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.17||||0.648|TWO_SIDED|95.0|0.516|2.675|||Bayesian repeated measures model|||Ang1-7 , Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 66 hours||2.675|0.516|0.6480
72343249|NCT01597635|144210679|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.76||||0.9038|TWO_SIDED|95.0|0.741|4.17|||Bayesian repeated measures model|||Ang1-7 , Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 72 hours||4.170|0.741|0.9038
72343250|NCT01597635|144210679|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.38||||0.7339|TWO_SIDED|95.0|0.49|3.915|||Bayesian repeated measures model|||Ang1-7 , Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 96 hours||3.915|0.490|0.7339
72343251|NCT01597635|144210679|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.38||||0.7714|TWO_SIDED|95.0|0.651|3.321|||Bayesian repeated measures model|||Ang1-7 , Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 120 hours||3.321|0.651|0.7714
72343252|NCT01597635|144210680|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.07||||1|TWO_SIDED|95.0|0.032|0.14|||Bayesian repeated measures model|||Ang II/Ang1-5, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 0.5 hours||0.140|0.032|1.0000
72343253|NCT01597635|144210680|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.1||||1|TWO_SIDED|95.0|0.048|0.209|||Bayesian repeated measures model|||Ang II/Ang1-5, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 2 hours||0.209|0.048|1.0000
72343254|NCT01597635|144210680|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.11||||1|TWO_SIDED|95.0|0.054|0.243|||Bayesian repeated measures model|||Ang II/Ang1-5, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 6 hours||0.243|0.054|1.0000
72343255|NCT01597635|144210680|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.25||||0.9996|TWO_SIDED|95.0|0.113|0.547|||Bayesian repeated measures model|||Ang II/Ang1-5, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 12 hours||0.547|0.113|0.9996
72343256|NCT01597635|144210680|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.29||||0.9991|TWO_SIDED|95.0|0.13|0.634|||Bayesian repeated measures model|||Ang II/Ang1-5, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 24 hours||0.634|0.130|0.9991
72343257|NCT01597635|144210680|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.32||||0.9979|TWO_SIDED|95.0|0.149|0.682|||Bayesian repeated measures model|||Ang II/Ang1-5, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 48 hours||0.682|0.149|0.9979
72343258|NCT01597635|144210680|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.19||||1||95.0|0.091|0.417|||Bayesian repeated measures model|||Ang II/Ang1-5, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 48.5 hours||0.417|0.091|1.0000
72343259|NCT01597635|144210680|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.25||||0.9998|TWO_SIDED|95.0|0.119|0.539|||Bayesian repeated measures model|||Ang II/Ang1-5, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 50 hours||0.539|0.119|0.9998
72343260|NCT01597635|144210680|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.31||||0.9985|TWO_SIDED|95.0|0.141|0.666|||Bayesian repeated measures model|||Ang II/Ang1-5, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 54 hours||0.666|0.141|0.9985
72343261|NCT01597635|144210680|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.34||||0.9977|TWO_SIDED|95.0|0.162|0.73|||Bayesian repeated measures model|||Ang II/Ang1-5, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 60 hours||0.730|0.162|0.9977
72343262|NCT01597635|144210680|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.22||||0.9999|TWO_SIDED|95.0|0.105|0.468|||Bayesian repeated measures model|||Ang II/Ang1-5, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 66 hours||0.468|0.105|0.9999
72343263|NCT01597635|144210680|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.26||||0.9996|TWO_SIDED|95.0|0.119|0.57|||Bayesian repeated measures model|||Ang II/Ang1-5, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 72 hours||0.570|0.119|0.9996
72343264|NCT01597635|144210680|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.82||||0.6621|TWO_SIDED|95.0|0.319|2.136|||Bayesian repeated measures model|||Ang II/Ang1-5, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 96 hours||2.136|0.319|0.6621
72343265|NCT01597635|144210680|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.79||||0.7085|TWO_SIDED|95.0|0.324|1.847|||Bayesian repeated measures model|||Ang II/Ang1-5, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 120 hours||1.847|0.324|0.7085
72343266|NCT01597635|144210680|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.06||||1|TWO_SIDED|95.0|0.028|0.14|||Bayesian repeated measures model|||Ang II/Ang1-7, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 0.5 hours||0.140|0.028|1.0000
72343267|NCT01597635|144210680|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.1||||1|TWO_SIDED|95.0|0.043|0.216|||Bayesian repeated measures model|||Ang II/Ang1-7, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 2 hours||0.216|0.043|1.0000
72343268|NCT01597635|144210680|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.08||||1|TWO_SIDED|95.0|0.034|0.177|||Bayesian repeated measures model|||Ang II/Ang1-7, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 6 hours||0.177|0.034|1.0000
72343269|NCT01597635|144210680|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.2||||0.9998|TWO_SIDED|95.0|0.086|0.453|||Bayesian repeated measures model|||Ang II/Ang1-7, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 12 hours||0.453|0.086|0.9998
72343270|NCT01597635|144210680|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.17||||0.9999|TWO_SIDED|95.0|0.075|0.4|||Bayesian repeated measures model|||Ang II/Ang1-7, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 24 hours||0.400|0.075|0.9999
72343271|NCT01597635|144210680|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.4||||0.9863|TWO_SIDED|95.0|0.173|0.901|||Bayesian repeated measures model|||Ang II/Ang1-7, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 48 hours||0.901|0.173|0.9863
72343272|NCT01597635|144210680|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.24||||0.9998|TWO_SIDED|95.0|0.103|0.529|||Bayesian repeated measures model|||Ang II/Ang1-7, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 48.5 hours||0.529|0.103|0.9998
72343273|NCT01597635|144210680|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.28||||0.9992|TWO_SIDED|95.0|0.119|0.626|||Bayesian repeated measures model|||Ang II/Ang1-7, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 50 hours||0.626|0.119|0.9992
72343274|NCT01597635|144210680|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.24||||0.9995|TWO_SIDED|95.0|0.102|0.561|||Bayesian repeated measures model|||Ang II/Ang1-7, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 54 hours||0.561|0.102|0.9995
72343275|NCT01597635|144210680|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.31||||0.9964|TWO_SIDED|95.0|0.131|0.729|||Bayesian repeated measures model|||Ang II/Ang1-7, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 60 hours||0.729|0.131|0.9964
72343276|NCT01597635|144210680|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.25||||0.9995|TWO_SIDED|95.0|0.107|0.584|||Bayesian repeated measures model|||Ang II/Ang1-7, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 66 hours||0.584|0.107|0.9995
72343277|NCT01597635|144210680|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.24||||0.9993|TWO_SIDED|95.0|0.098|0.578|||Ratio of Active/Placebo|||Ang II/Ang1-7, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 72 hours||0.578|0.098|0.9993
72343278|NCT01597635|144210680|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.34||||0.9781|TWO_SIDED|95.0|0.119|0.969|||Bayesian repeated measures model|||Ang II/Ang1-7, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 96 hours||0.969|0.119|0.9781
72343279|NCT01597635|144210680|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.38||||0.9375|TWO_SIDED|95.0|0.154|1.341|||Bayesian repeated measures model|||Ang II/Ang1-7, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 120 hours||1.341|0.154|0.9375
72343280|NCT01597635|144210681|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.93||||0.2598|TWO_SIDED|95.0|0.752|1.215|||Bayesian repeated measures model|||PEEP, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 0.5 hours||1.215|0.752|0.2598
72343281|NCT01597635|144210681|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.97||||0.3949|TWO_SIDED|95.0|0.783|1.273|||Bayesian repeated measures model|||PEEP, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 1 hour||1.273|0.783|0.3949
72343282|NCT01597635|144210681|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.98||||0.4175|TWO_SIDED|95.0|0.791|1.294|||Bayesian repeated measures model|||PEEP, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 2 hours||1.294|0.791|0.4175
72343283|NCT01597635|144210681|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.98||||0.442|TWO_SIDED|95.0|0.806|1.292|||Bayesian repeated measures model|||PEEP, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 4 hours||1.292|0.806|0.4420
72343284|NCT01597635|144210681|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.99||||0.4432|TWO_SIDED|95.0|0.811|1.262|||Bayesian repeated measures model|||PEEP, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 6 hours||1.262|0.811|0.4432
72343285|NCT01597635|144210681|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.99||||0.4578|TWO_SIDED|95.0|0.818|1.229|||Bayesian repeated measures model|||PEEP, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 8 hours||1.229|0.818|0.4578
72343286|NCT01597635|144210681|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.96||||0.3365|TWO_SIDED|95.0|0.79|1.167|||Bayesian repeated measures model|||PEEP, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 12 hours||1.167|0.790|0.3365
72343287|NCT01597635|144210681|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.95||||0.3339|TWO_SIDED|95.0|0.77|1.163|||Bayesian repeated measures model|||PEEP, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 18 hours||1.163|0.770|0.3339
72343288|NCT01597635|144210681|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.96||||0.3608|TWO_SIDED|95.0|0.786|1.166|||Bayesian repeated measures model|||PEEP, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 24 hours||1.166|0.786|0.3608
72343289|NCT01597635|144210681|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.96||||0.3584|TWO_SIDED|95.0|0.788|1.168|||Bayesian repeated measures model|||PEEP, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 24.5 hours||1.168|0.788|0.3584
72343290|NCT01597635|144210681|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.88||||0.1219|TWO_SIDED|95.0|0.725|1.073|||Bayesian repeated measures model|||PEEP, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 25 hours||1.073|0.725|0.1219
72343291|NCT01597635|144210681|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.99||||0.4662|TWO_SIDED|95.0|0.814|1.21|||Bayesian repeated measures model|||PEEP, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 26 hours||1.210|0.814|0.4662
72343292|NCT01597635|144210681|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.02||||0.5748|TWO_SIDED|95.0|0.828|1.247|||Bayesian repeated measures model|||PEEP, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 28 hours||1.247|0.828|0.5748
72343293|NCT01597635|144210681|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.97||||0.4104|TWO_SIDED|95.0|0.786|1.204|||Bayesian repeated measures model|||PEEP, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 30 hours||1.204|0.786|0.4104
72343294|NCT01597635|144210681|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.0||||0.5114|TWO_SIDED|95.0|0.817|1.246|||Bayesian repeated measures model|||PEEP, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 32 hours||1.246|0.817|0.5114
72343295|NCT01597635|144210681|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.98||||0.4213|TWO_SIDED|95.0|0.783|1.2|||Bayesian repeated measures model|||PEEP, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 36 hours||1.200|0.783|0.4213
72343296|NCT01597635|144210681|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.93||||0.2663|TWO_SIDED|95.0|0.731|1.132|||Bayesian repeated measures model|||PEEP, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 42 hours||1.132|0.731|0.2663
72343297|NCT01597635|144210681|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.91||||0.2373|TWO_SIDED|95.0|0.72|1.142|||Bayesian repeated measures model|||PEEP, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 48 hours||1.142|0.720|0.2373
72343298|NCT01597635|144210681|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.92||||0.2575|TWO_SIDED|95.0|0.721|1.149|||Bayesian repeated measures model|||PEEP, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 48.5 hours||1.149|0.721|0.2575
72343299|NCT01597635|144210681|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.9||||0.2173|TWO_SIDED|95.0|0.708|1.127|||Bayesian repeated measures model|||PEEP, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 49 hours||1.127|0.708|0.2173
72343300|NCT01597635|144210681|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.91||||0.2406|TWO_SIDED|95.0|0.717|1.143|||Bayesian repeated measures model|||PEEP, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 50 hours||1.143|0.717|0.2406
72343301|NCT01597635|144210681|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.92||||0.2471|TWO_SIDED|95.0|0.721|1.151|||Bayesian repeated measures model|||PEEP, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 52 hours||1.151|0.721|0.2471
72343302|NCT01597635|144210681|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.93||||0.2585|TWO_SIDED|95.0|0.727|1.157|||Bayesian repeated measures model|||PEEP, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 54 hours||1.157|0.727|0.2585
72343303|NCT01597635|144210681|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.94||||0.3101|TWO_SIDED|95.0|0.737|1.17|||Bayesian repeated measures model|||PEEP, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 56 hours||1.170|0.737|0.3101
72343304|NCT01597635|144210681|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.92||||0.2476|TWO_SIDED|95.0|0.727|1.16|||Bayesian repeated measures model|||PEEP, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 60 hours||1.160|0.727|0.2476
72343305|NCT01597635|144210681|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.96||||0.3887|TWO_SIDED|95.0|0.767|1.222|||Bayesian repeated measures model|||PEEP, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 66 hours||1.222|0.767|0.3887
72343306|NCT01597635|144210681|SUPERIORITY||Ratio of Active/Placebo|0.92||||0.2294|TWO_SIDED|95.0|0.749|1.146|||Bayesian repeated measures model|||PEEP, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 72 hours||1.146|0.749|0.2294
72343307|NCT01597635|144210681|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.09||||0.8522|TWO_SIDED|95.0|0.916|1.234|||Bayesian repeated measures model|||PEEP, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 168 hours||1.234|0.916|0.8522
72343308|NCT01597635|144210681|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.02||||0.5885|TWO_SIDED|95.0|0.89|1.164|||Bayesian repeated measures model|||Peak ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 0.5 hours||1.164|0.890|0.5885
72343309|NCT01597635|144210681|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.07||||0.8558|TWO_SIDED|95.0|0.94|1.23|||Bayesian repeated measures model|||Peak ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 1 hour||1.230|0.940|0.8558
72343310|NCT01597635|144210681|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.07||||0.8374|TWO_SIDED|95.0|0.932|1.224|||Bayesian repeated measures model|||Peak ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 2 hour||1.224|0.932|0.8374
72343311|NCT01597635|144210681|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.01||||0.5886|TWO_SIDED|95.0|0.887|1.152|||Bayesian repeated measures model|||Peak ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 4 hours||1.152|0.887|0.5886
72343312|NCT01597635|144210681|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.05||||0.7532|TWO_SIDED|95.0|0.918|1.18|||Bayesian repeated measures model|||Peak ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 6 hours||1.180|0.918|0.7532
72343313|NCT01597635|144210681|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.04||||0.7108|TWO_SIDED|95.0|0.906|1.179|||Bayesian repeated measures model|||Peak ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 8 hours||1.179|0.906|0.7108
72343314|NCT01597635|144210681|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.04||||0.7445|TWO_SIDED|95.0|0.918|1.19|||Bayesian repeated measures model|||Peak ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 12 hours||1.190|0.918|0.7445
72343315|NCT01597635|144210681|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.98||||0.3759|TWO_SIDED|95.0|0.863|1.115|||Bayesian repeated measures model|||Peak ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 18 hours||1.115|0.863|0.3759
72343316|NCT01597635|144210681|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.98||||0.398|TWO_SIDED|95.0|0.859|1.118|||Bayesian repeated measures model|||Peak ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 24 hours||1.118|0.859|0.3980
72343317|NCT01597635|144210681|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.97||||0.3231|TWO_SIDED|95.0|0.849|1.103|||Bayesian repeated measures model|||Peak ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 24.5 hours||1.103|0.849|0.3231
72343318|NCT01597635|144210681|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.93||||0.1245|TWO_SIDED|95.0|0.812|1.056|||Bayesian repeated measures model|||Peak ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 25 hours||1.056|0.812|0.1245
72343319|NCT01597635|144210681|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.99||||0.4631|TWO_SIDED|95.0|0.87|1.134|||Bayesian repeated measures model|||Peak ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 26 hours||1.134|0.870|0.4631
72343320|NCT01597635|144210681|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.92||||0.1026|TWO_SIDED|95.0|0.801|1.047|||Bayesian repeated measures model|||Peak ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 28 hours||1.047|0.801|0.1026
72343321|NCT01597635|144210681|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.97||||0.3152|TWO_SIDED|95.0|0.85|1.101|||Bayesian repeated measures model|||Peak ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 30 hours||1.101|0.850|0.3152
72343322|NCT01597635|144210681|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.91||||0.0762|TWO_SIDED|95.0|0.803|1.035|||Bayesian repeated measures model|||Peak ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 32 hours||1.035|0.803|0.0762
72343323|NCT01597635|144210681|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.88||||0.0274||95.0|0.763|1.003|||Bayesian repeated measures model|||Peak ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 36 hours||1.003|0.763|0.0274
72343324|NCT01597635|144210681|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.98||||0.3594|TWO_SIDED|95.0|0.853|1.112|||Bayesian repeated measures model|||Peak ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 42 hours||1.112|0.853|0.3594
72343325|NCT01597635|144210681|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.04||||0.7027|TWO_SIDED|95.0|0.906|1.197|||Bayesian repeated measures model|||Peak ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 48 hours||1.197|0.906|0.7027
72343326|NCT01597635|144210681|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.08||||0.8661|TWO_SIDED|95.0|0.941|1.246|||Bayesian repeated measures model|||Peak ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 48.5 hours||1.246|0.941|0.8661
72343327|NCT01597635|144210681|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.06||||0.8084|TWO_SIDED|95.0|0.924|1.228|||Bayesian repeated measures model|||Peak ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 49 hours||1.228|0.924|0.8084
72343328|NCT01597635|144210681|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.13||||0.9504|TWO_SIDED|95.0|0.976|1.3|||Bayesian repeated measures model|||Peak ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 50 hours||1.300|0.976|0.9504
72343329|NCT01597635|144210681|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.01||||0.53|TWO_SIDED|95.0|0.871|1.164|||Bayesian repeated measures model|||Peak ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 52 hours||1.164|0.871|0.5300
72343330|NCT01597635|144210681|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.08||||0.8595|TWO_SIDED|95.0|0.942|1.243|||Bayesian repeated measures model|||Peak ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 54 hours||1.243|0.942|0.8595
72343331|NCT01597635|144210681|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.09||||0.8802|TWO_SIDED|95.0|0.943|1.261|||Bayesian repeated measures model|||Peak ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 56 hours||1.261|0.943|0.8802
72343332|NCT01597635|144210681|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.11||||0.9232|TWO_SIDED|95.0|0.958|1.278|||Bayesian repeated measures model|||Peak ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 60 hours||1.278|0.958|0.9232
72343333|NCT01597635|144210681|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.07||||0.7911|TWO_SIDED|95.0|0.902|1.256|||Bayesian repeated measures model|||Peak ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 66 hours||1.256|0.902|0.7911
72343334|NCT01597635|144210681|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.28||||0.9946|TWO_SIDED|95.0|1.059|1.514|||Bayesian repeated measures model|||Peak ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 72 hours||1.514|1.059|0.9946
72343335|NCT01597635|144210681|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.26||||0.983|TWO_SIDED|95.0|1.019|1.444|||Bayesian repeated measures model|||Peak ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 168 hours||1.444|1.019|0.9830
72343336|NCT01597635|144210681|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.08||||0.8024|TWO_SIDED|95.0|0.91|1.261|||Bayesian repeated measures model|||Plateau ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 0.5 hours||1.261|0.910|0.8024
72343337|NCT01597635|144210681|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.0||||0.4806|TWO_SIDED|95.0|0.843|1.166|||Bayesian repeated measures model|||Plateau ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 1 hour||1.166|0.843|0.4806
72343338|NCT01597635|144210681|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.04||||0.6658|TWO_SIDED|95.0|0.869|1.223|||Bayesian repeated measures model|||Plateau ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 2 hours||1.223|0.869|0.6658
72343339|NCT01597635|144210681|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.03||||0.6131|TWO_SIDED|95.0|0.856|1.212|||Bayesian repeated measures model|||Plateau ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 4 hours||1.212|0.856|0.6131
72343340|NCT01597635|144210681|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.02||||0.5795|TWO_SIDED|95.0|0.856|1.197|||Bayesian repeated measures model|||Plateau ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 6 hours||1.197|0.856|0.5795
72343341|NCT01597635|144210681|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.85||||0.0209|TWO_SIDED|95.0|0.716|0.993|||Bayesian repeated measures model|||Plateau ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 8 hours||0.993|0.716|0.0209
72343342|NCT01597635|144210681|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.0||||0.4823|TWO_SIDED|95.0|0.83|1.187|||Mixed Models Analysis|||Plateau ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 12 hours||1.187|0.830|0.4823
72343343|NCT01597635|144210681|SUPERIORITY_OR_OTHER||0.0406|0.85||||0.0406|TWO_SIDED|95.0|0.703|1.021|||Bayesian repeated measures model|||Plateau ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 18 hours||1.021|0.703|0.0406
72343344|NCT01597635|144210681|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.0||||0.5186|TWO_SIDED|95.0|0.844|1.169|||Bayesian repeated measures model|||Plateau ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 24 hours||1.169|0.844|0.5186
72343345|NCT01597635|144210681|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.98||||0.387|TWO_SIDED|95.0|0.824|1.132|||Bayesian repeated measures model|||Plateau ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 24.5 hours||1.132|0.824|0.3870
72343346|NCT01597635|144210681|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.91||||0.1281|TWO_SIDED|95.0|0.77|1.065|||Bayesian repeated measures model|||Plateau ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 25 hours||1.065|0.770|0.1281
72343347|NCT01597635|144210681|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.99||||0.4754|TWO_SIDED|95.0|0.837|1.181|||Bayesian repeated measures model|||Plateau ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 26 hours||1.181|0.837|0.4754
72343348|NCT01597635|144210681|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.01||||0.5627|TWO_SIDED|95.0|0.856|1.217|||Bayesian repeated measures model|||Plateau ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 28 hours||1.217|0.856|0.5627
72343349|NCT01597635|144210681|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.01||||0.5552|TWO_SIDED|95.0|0.848|1.22|||Bayesian repeated measures model|||Plateau ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 30 hours||1.220|0.848|0.5552
72343350|NCT01597635|144210681|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.0||||0.503|TWO_SIDED|95.0|0.843|1.201|||Bayesian repeated measures model|||Plateau ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 32 hours||1.201|0.843|0.5030
72343351|NCT01597635|144210681|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.01||||0.5558|TWO_SIDED|95.0|0.84|1.218|||Bayesian repeated measures model|||Plateau ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 36 hours||1.218|0.840|0.5558
72343352|NCT01597635|144210681|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.94||||0.2709|TWO_SIDED|95.0|0.769|1.135|||Bayesian repeated measures model|||Plateau ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 42 hours||1.135|0.769|0.2709
72343353|NCT01597635|144210681|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.98||||0.4143|TWO_SIDED|95.0|0.795|1.208|||Bayesian repeated measures model|||Plateau ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 48 hours||1.208|0.795|0.4143
72343354|NCT01597635|144210681|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.09||||0.7886|TWO_SIDED|95.0|0.891|1.348|||Bayesian repeated measures model|||Plateau ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 48.5 hours||1.348|0.891|0.7886
72343355|NCT01597635|144210681|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.08||||0.7607|TWO_SIDED|95.0|0.885|1.353|||Bayesian repeated measures model|||Plateau ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 49 hours||1.353|0.885|0.7607
72343356|NCT01597635|144210681|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.13||||0.8677|TWO_SIDED|95.0|0.922|1.4|||Bayesian repeated measures model|||Plateau ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 50 hours||1.400|0.922|0.8677
72343357|NCT01597635|144210681|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.06||||0.7012|TWO_SIDED|95.0|0.847|1.302|||Bayesian repeated measures model|||Plateau ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 52 hours||1.302|0.847|0.7012
72370076|NCT04173494|144250582|OTHER||Stratified CMH|15.68||||0.0282|TWO_SIDED|95.0|2.47|28.9|||Cochran-Mantel-Haenszel||\>=1.5g/dL Increase in Hemoglobin response|||28.90|2.47|0.0282
72343358|NCT01597635|144210681|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.0||||0.5156|TWO_SIDED|95.0|0.805|1.23|||Bayesian repeated measures model|||Plateau ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 54 hours||1.230|0.805|0.5156
72343359|NCT01597635|144210681|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.96||||0.3524|TWO_SIDED|95.0|0.783|1.178|||Bayesian repeated measures model|||Plateau ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 56 hours||1.178|0.783|0.3524
72343360|NCT01597635|144210681|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.04||||0.638|TWO_SIDED|95.0|0.845|1.292|||Bayesian repeated measures model|||Plateau ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 60 hours||1.292|0.845|0.6380
72343361|NCT01597635|144210681|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.96||||0.4003|TWO_SIDED|95.0|0.743|1.241|||Bayesian repeated measures model|||Plateau ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 66 hours||1.241|0.743|0.4003
72343362|NCT01597635|144210681|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.16||||0.8817|TWO_SIDED|95.0|0.907|1.502|||Bayesian repeated measures model|||Plateau ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 72 hours||1.502|0.907|0.8817
72343363|NCT01597635|144210681|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.14||||0.8145|TWO_SIDED|95.0|0.804|1.505|||Bayesian repeated measures model|||Plateau ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 168 hours||1.505|0.804|0.8145
72343364|NCT01597635|144210682|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.05||||0.6468|TWO_SIDED|95.0|0.765|1.321|||Bayesian repeated measures model|||PaO2/FiO2, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 0.5 hours||1.321|0.765|0.6468
72343365|NCT01597635|144210682|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.9||||0.1965|TWO_SIDED|95.0|0.658|1.136|||Bayesian repeated measures model|||PaO2/FiO2, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 1 hour||1.136|0.658|0.1965
72343366|NCT01597635|144210682|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.9||||0.1681|TWO_SIDED|95.0|0.694|1.129|||Bayesian repeated measures model|||PaO2/FiO2, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 2 hours||1.129|0.694|0.1681
72343367|NCT01597635|144210682|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.85||||0.0877|TWO_SIDED|95.0|0.669|1.075|||Bayesian repeated measures model|||PaO2/FiO2, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 4 hours||1.075|0.669|0.0877
72343368|NCT01597635|144210682|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.9||||0.2011|TWO_SIDED|95.0|0.715|1.159|||Bayesian repeated measures model|||PaO2/FiO2, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 6 hours||1.159|0.715|0.2011
72343369|NCT01597635|144210682|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.06||||0.6855|TWO_SIDED|95.0|0.842|1.345|||Bayesian repeated measures model|||PaO2/FiO2, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 8 hours||1.345|0.842|0.6855
72343370|NCT01597635|144210682|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.04||||0.6093|TWO_SIDED|95.0|0.8|1.325|||Bayesian repeated measures model|||PaO2/FiO2, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 12 hours||1.325|0.800|0.6093
72343371|NCT01597635|144210682|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.98||||0.435|TWO_SIDED|95.0|0.765|1.253|||Bayesian repeated measures model|||PaO2/FiO2, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 18 hours||1.253|0.765|0.4350
72343372|NCT01597635|144210682|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.91||||0.2232|TWO_SIDED|95.0|0.722|1.195|||Bayesian repeated measures model|||PaO2/FiO2, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 24 hours||1.195|0.722|0.2232
72343373|NCT01597635|144210682|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.93||||0.2716|TWO_SIDED|95.0|0.733|1.2|||Bayesian repeated measures model|||PaO2/FiO2, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 24.5 hours||1.200|0.733|0.2716
72343374|NCT01597635|144210682|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.93||||0.2866|TWO_SIDED|95.0|0.726|1.19|||Bayesian repeated measures model|||PaO2/FiO2, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 25 hours||1.190|0.726|0.2866
72428656|NCT01755689|144368337|NON_INFERIORITY|The non-inferiority criteria: the UL of the 2-sided standardised asymptotic 95% CI for the ratio of rSBA GMTs had to be below the pre-defined limit of 2.|Adjusted GMT Ratio|1.01|||||TWO_SIDED|95.0|0.84|1.21|||ANCOVA|||Adjusted GMT ratio of the Nimenrix Group versus Nimenrix+Cervarix Group in terms of rSBA-MenA titers.||1.21|0.84|
72343375|NCT01597635|144210682|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.0||||0.5033|TWO_SIDED|95.0|0.78|1.27|||Bayesian repeated measures model|||PaO2/FiO2, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 26 hours||1.270|0.780|0.5033
72343376|NCT01597635|144210682|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.88||||0.1493|TWO_SIDED|95.0|0.684|1.12|||Bayesian repeated measures model|||PaO2/FiO2, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 28 hours||1.120|0.684|0.1493
72343377|NCT01597635|144210682|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.0||||0.4947|TWO_SIDED|95.0|0.759|1.301|||Bayesian repeated measures model|||PaO2/FiO2, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 30 hours||1.301|0.759|0.4947
72343378|NCT01597635|144210682|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.89||||0.1951|TWO_SIDED|95.0|0.678|1.161|||Bayesian repeated measures model|||PaO2/FiO2, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 32 hours||1.161|0.678|0.1951
72343379|NCT01597635|144210682|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.8||||0.0512|TWO_SIDED|95.0|0.612|1.05|||Bayesian repeated measures model|||PaO2/FiO2, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 36 hours||1.050|0.612|0.0512
72343380|NCT01597635|144210682|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.99||||0.47|TWO_SIDED|95.0|0.775|1.279|||Bayesian repeated measures model|||PaO2/FiO2, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 42 hours||1.279|0.775|0.4700
72343381|NCT01597635|144210682|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.05||||0.634|TWO_SIDED|95.0|0.811|1.368|||Bayesian repeated measures model|||PaO2/FiO2, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 48 hours||1.368|0.811|0.6340
72343382|NCT01597635|144210682|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.9||||0.2129|TWO_SIDED|95.0|0.689|1.183|||Bayesian repeated measures model|||PaO2/FiO2, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 48.5 hours||1.183|0.689|0.2129
72343383|NCT01597635|144210682|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.05||||0.6418|TWO_SIDED|95.0|0.798|1.411|||Bayesian repeated measures model|||PaO2/FiO2, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 49 hours||1.411|0.798|0.6418
72343384|NCT01597635|144210682|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.99||||0.4797|TWO_SIDED|95.0|0.754|1.315|||Ratio of Active/Placebo|||PaO2/FiO2, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 50 hours||1.315|0.754|0.4797
72343385|NCT01597635|144210682|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.92||||0.2659|TWO_SIDED|95.0|0.703|1.199|||Bayesian repeated measures model|||PaO2/FiO2, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 52 hours||1.199|0.703|0.2659
72343386|NCT01597635|144210682|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.9||||0.2102|TWO_SIDED|95.0|0.687|1.159|||Bayesian repeated measures model|||PaO2/FiO2, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 54 hours||1.159|0.687|0.2102
72343387|NCT01597635|144210682|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.96||||0.3623|TWO_SIDED|95.0|0.74|1.24|||Bayesian repeated measures model|||PaO2/FiO2, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 56 hours||1.240|0.740|0.3623
72343388|NCT01597635|144210682|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.95||||0.3499|TWO_SIDED|95.0|0.73|1.225|||Bayesian repeated measures model|||PaO2/FiO2, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 60 hours||1.225|0.730|0.3499
72343389|NCT01597635|144210682|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.05||||0.6494|TWO_SIDED|95.0|0.787|1.377|||Bayesian repeated measures model|||PaO2/FiO2, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 66 hours||1.377|0.787|0.6494
72343390|NCT01597635|144210682|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.02||||0.5567|TWO_SIDED|95.0|0.766|1.358|||Bayesian repeated measures model|||PaO2/FiO2, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 72 hours||1.358|0.766|0.5567
72343391|NCT01597635|144210682|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.85||||0.1095|TWO_SIDED|95.0|0.615|1.073|||Bayesian repeated measures model|||PaO2/FiO2, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 168 hours||1.073|0.615|0.1095
72343392|NCT01597635|144210683|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.06||||0.6098|TWO_SIDED|95.0|0.721|1.644|||Bayesian repeated measures model|||Oxygenation index, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 0.5 hours||1.644|0.721|0.6098
72343393|NCT01597635|144210683|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.35||||0.9441|TWO_SIDED|95.0|0.931|2.068|||Bayesian repeated measures model|||Oxygenation index, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 1 hour||2.068|0.931|0.9441
72343394|NCT01597635|144210683|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.12||||0.7173|TWO_SIDED|95.0|0.749|1.621|||Bayesian repeated measures model|||Oxygenation index, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 2 hours||1.621|0.749|0.7173
72343395|NCT01597635|144210683|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.26||||0.8292|TWO_SIDED|95.0|0.81|1.949|||Bayesian repeated measures model|||Oxygenation index, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 4 hours||1.949|0.810|0.8292
72343396|NCT01597635|144210683|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.23||||0.8008|TWO_SIDED|95.0|0.775|1.832|||Bayesian repeated measures model|||Oxygenation index, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 6 hours||1.832|0.775|0.8008
72343397|NCT01597635|144210683|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.2||||0.7905|TWO_SIDED|95.0|0.776|1.799|||Bayesian repeated measures model|||Oxygenation index, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 8 hours||1.799|0.776|0.7905
72343398|NCT01597635|144210683|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.17||||0.7566|TWO_SIDED|95.0|0.737|1.958|||Bayesian repeated measures model|||Oxygenation index, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 12 hours||1.958|0.737|0.7566
72343399|NCT01597635|144210683|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.25||||0.8349|TWO_SIDED|95.0|0.812|2.05|||Bayesian repeated measures model|||Oxygenation index, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 18 hours||2.050|0.812|0.8349
72343400|NCT01597635|144210683|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.99||||0.4739|TWO_SIDED|95.0|0.713|1.527|||Bayesian repeated measures model|||Oxygenation index, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 24 hours||1.527|0.713|0.4739
72343401|NCT01597635|144210683|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.06||||0.6291|TWO_SIDED|95.0|0.763|1.647|||Bayesian repeated measures model|||Oxygenation index, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 24.5 hours||1.647|0.763|0.6291
72343402|NCT01597635|144210683|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.18||||0.8032|TWO_SIDED|95.0|0.83|1.814|||Bayesian repeated measures model|||Oxygenation index, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 25 hours||1.814|0.830|0.8032
72343403|NCT01597635|144210683|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.91||||0.325|TWO_SIDED|95.0|0.626|1.416|||Bayesian repeated measures model|||Oxygenation index, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 26 hours||1.416|0.626|0.3250
72343404|NCT01597635|144210683|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.05||||0.5828|TWO_SIDED|95.0|0.687|1.63|||Bayesian repeated measures model|||Oxygenation index, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 28 hours||1.630|0.687|0.5828
72343405|NCT01597635|144210683|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.98||||0.4546|TWO_SIDED|95.0|0.661|1.512|||Bayesian repeated measures model|||Oxygenation index, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 30 hours||1.512|0.661|0.4546
72343406|NCT01597635|144210683|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.06||||0.6158|TWO_SIDED|95.0|0.719|1.639|||Bayesian repeated measures model|||Oxygenation index, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 32 hours||1.639|0.719|0.6158
72343407|NCT01597635|144210683|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.17||||0.7748|TWO_SIDED|95.0|0.752|1.77|||Bayesian repeated measures model|||Oxygenation index, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 36 hours||1.770|0.752|0.7748
72343408|NCT01597635|144210683|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.09||||0.6565|TWO_SIDED|95.0|0.686|1.714|||Bayesian repeated measures model|||Oxygenation index, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 42 hours||1.714|0.686|0.6565
72343409|NCT01597635|144210683|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.87||||0.2773|TWO_SIDED|95.0|0.566|1.38|||Bayesian repeated measures model|||Oxygenation index, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 48 hours||1.380|0.566|0.2773
72343410|NCT01597635|144210683|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.92||||0.3606|TWO_SIDED|95.0|0.61|1.467|||Bayesian repeated measures model|||Oxygenation index, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 48.5 hours||1.467|0.610|0.3606
72343411|NCT01597635|144210683|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.83||||0.2211|TWO_SIDED|95.0|0.555|1.317|||Bayesian repeated measures model|||Oxygenation index, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 49 hours||1.317|0.555|0.2211
72343412|NCT01597635|144210683|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.88||||0.286|TWO_SIDED|95.0|0.587|1.348|||Bayesian repeated measures model|||Oxygenation index, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 50 hours||1.348|0.587|0.2860
72343413|NCT01597635|144210683|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.94||||0.4079|TWO_SIDED|95.0|0.609|1.51|||Bayesian repeated measures model|||Oxygenation index, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 52 hours||1.510|0.609|0.4079
72343414|NCT01597635|144210683|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.02||||0.5284|TWO_SIDED|95.0|0.614|1.663|||Bayesian repeated measures model|||Oxygenation index, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 54 hours||1.663|0.614|0.5284
72343415|NCT01597635|144210683|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.9||||0.3586|TWO_SIDED|95.0|0.568|1.458|||Bayesian repeated measures model|||Oxygenation index, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 56 hours||1.458|0.568|0.3586
72343416|NCT01597635|144210683|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.13||||0.6768|TWO_SIDED|95.0|0.672|1.853|||Bayesian repeated measures model|||Oxygenation index, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 60 hours||1.853|0.672|0.6768
72343417|NCT01597635|144210683|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.77||||0.1574|TWO_SIDED|95.0|0.488|1.39|||Bayesian repeated measures model|||Oxygenation index, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 66 hours||1.390|0.488|0.1574
72343418|NCT01597635|144210683|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.92||||0.39|TWO_SIDED|95.0|0.521|1.584|||Bayesian repeated measures model|||Oxygenation index, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 72 hours||1.584|0.521|0.3900
72343419|NCT01597635|144210683|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.05||||0.5915|TWO_SIDED|95.0|0.748|1.516|||Bayesian repeated measures model|||Oxygenation index, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 168 hours||1.516|0.748|0.5915
72343420|NCT01597635|144210686|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.88||||0.06828|TWO_SIDED|95.0|0.528|1.501|||Bayesian repeated measures model|||CXCL-8 (IL-8), Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 12 hours||1.501|0.528|0.06828
72343421|NCT01597635|144210686|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.96||||0.5674|TWO_SIDED|95.0|0.57|1.609|||Bayesian repeated measures model|||CXCL-8 (IL-8), Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 24 hours||1.609|0.570|0.5674
72343422|NCT01597635|144210686|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.66||||0.8855|TWO_SIDED|95.0|0.321|1.316|||Bayesian repeated measures model|||CXCL-8 (IL-8), Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 48 hours||1.316|0.321|0.8855
72343423|NCT01597635|144210686|SUPERIORITY||Ratio of Active/Placebo|0.97||||0.5358|TWO_SIDED|95.0|0.531|1.76|||Bayesian repeated measures model|||CXCL-8 (IL-8), Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 72 hours||1.760|0.531|0.5358
72343424|NCT01597635|144210686|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.17||||0.699|TWO_SIDED|95.0|0.622|2.155|||Bayesian repeated measures model|||CXCL-8 (IL-8), Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 120 hours||2.155|0.622|0.6990
72428657|NCT01755689|144368337|NON_INFERIORITY|The non-inferiority criteria: the UL of the 2-sided standardised asymptotic 95% CI for the ratio of rSBA GMTs had to be below the pre-defined limit of 2.|Adjusted GMT Ratio|1.19|||||TWO_SIDED|95.0|0.93|1.51|||ANCOVA|||Adjusted GMT ratio of the Nimenrix Group versus Nimenrix+Cervarix+Boostrix Group in terms of rSBA-MenC titers.||1.51|0.93|
72428658|NCT01755689|144368337|NON_INFERIORITY|The non-inferiority criteria: the UL of the 2-sided standardised asymptotic 95% CI for the ratio of rSBA GMTs had to be below the pre-defined limit of 2.|Adjusted GMT Ratio|0.83|||||TWO_SIDED|95.0|0.66|1.06|||ANCOVA|||Adjusted GMT ratio of the Nimenrix Group versus Nimenrix+Cervarix Group in terms of rSBA-MenC titers.||1.06|0.66|
72343425|NCT01597635|144210686|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.99||||0.513|TWO_SIDED|95.0|0.549|1.721|||Bayesian repeated measures model|||IL-6, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 12 hours||1.721|0.549|0.5130
72343426|NCT01597635|144210686|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.73||||0.7696|TWO_SIDED|95.0|0.3|1.731|||Bayesian repeated measures model|||IL-6, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 24 hours||1.731|0.300|0.7696
72343427|NCT01597635|144210686|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.51||||0.9254|TWO_SIDED|95.0|0.203|1.289|||Bayesian repeated measures model|||IL-6, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 48 hours||1.289|0.203|0.9254
72343428|NCT01597635|144210686|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.72||||0.7088|TWO_SIDED|95.0|0.216|2.419|||Bayesian repeated measures model|||IL-6, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 72 hours||2.419|0.216|0.7088
72343429|NCT01597635|144210686|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.47||||0.8787|TWO_SIDED|95.0|0.112|1.69|||Bayesian repeated measures model|||IL-6, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 120 hours||1.690|0.112|0.8787
72343430|NCT01597635|144210686|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.92||||0.7338|TWO_SIDED|95.0|0.714|1.197|||Bayesian repeated measures model|||RAGE, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 12 hours||1.197|0.714|0.7338
72343431|NCT01597635|144210686|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.0||||0.4955|TWO_SIDED|95.0|0.703|1.415|||Bayesian repeated measures model|||RAGE, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 24 hours||1.415|0.703|0.4955
72343432|NCT01597635|144210686|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.98||||0.5264|TWO_SIDED|95.0|0.541|1.788|||Bayesian repeated measures model|||RAGE, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 48 hours||1.788|0.541|0.5264
72343433|NCT01597635|144210686|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.91||||0.6183|TWO_SIDED|95.0|0.454|1.742|||Bayesian repeated measures model|||RAGE, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 72 hours||1.742|0.454|0.6183
72343434|NCT01597635|144210686|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.03||||0.5291|TWO_SIDED|95.0|0.483|2.118|||Bayesian repeated measures model|||RAGE, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 120 hours||2.118|0.483|0.5291
72343435|NCT01597635|144210686|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.09||||0.74|TWO_SIDED|95.0|0.828|1.448|||Bayesian repeated measures model|||MPO, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 12 hours||1.448|0.828|0.7400
72343436|NCT01597635|144210686|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.25||||0.9375|TWO_SIDED|95.0|0.937|1.683|||Bayesian repeated measures model|||MPO, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 24 hours||1.683|0.937|0.9375
72343437|NCT01597635|144210686|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.26||||0.9118|TWO_SIDED|95.0|0.896|1.771|||Bayesian repeated measures model|||MPO, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 48 hours||1.771|0.896|0.9118
72343438|NCT01597635|144210686|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.43||||0.9217|TWO_SIDED|95.0|0.866|2.382|||Bayesian repeated measures model|||MPO, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 72 hours||2.382|0.866|0.9217
72343439|NCT01597635|144210686|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.48||||0.8676|TWO_SIDED|95.0|0.73|3.064|||Bayesian repeated measures model|||MPO, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 120 hours||3.064|0.730|0.8676
72343440|NCT01597635|144210686|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.83||||0.8835|TWO_SIDED|95.0|0.609|1.135|||Bayesian repeated measures model|||Angiopoietin-2, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 12 hours||1.135|0.609|0.8835
72343441|NCT01597635|144210686|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.98||||0.5446|TWO_SIDED|95.0|0.723|1.33|||Bayesian repeated measures model|||Angiopoietin-2, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 24 hours||1.330|0.723|0.5446
72343442|NCT01597635|144210686|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.95||||0.6267|TWO_SIDED|95.0|0.679|1.333|||Bayesian repeated measures model|||Angiopoietin-2, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 48 hours||1.333|0.679|0.6267
72343443|NCT01597635|144210686|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.88||||0.7668|TWO_SIDED|95.0|0.612|1.26|||Bayesian repeated measures model|||Angiopoietin-2, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 72 hours||1.260|0.612|0.7668
72343444|NCT01597635|144210686|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.94||||0.61|TWO_SIDED|95.0|0.588|1.509|||Bayesian repeated measures model|||Angiopoietin-2, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 120 hours||1.509|0.588|0.6100
72343445|NCT01597635|144210686|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.68||||0.8159|TWO_SIDED|95.0|0.291|1.623|||Bayesian repeated measures model|||Renin, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 72 hours||1.623|0.291|0.8159
72343446|NCT01597635|144210686|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.53||||0.7988|TWO_SIDED|95.0|0.106|2.657|||Bayesian repeated measures model|||Aldosterone, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 72 hours||2.657|0.106|0.7988
72343447|NCT01597635|144210687|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.12||||0.6536|TWO_SIDED|95.0|0.626|2.024|||Bayesian repeated measures model|||CRP, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 12 hours||2.024|0.626|0.6536
72343448|NCT01597635|144210687|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.3||||0.9066|TWO_SIDED|95.0|0.876|1.955|||Bayesian repeated measures model|||CRP, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 24 hours||1.955|0.876|0.9066
72343449|NCT01597635|144210687|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.23||||0.7859|TWO_SIDED|95.0|0.723|2.066|||Bayesian repeated measures model|||CRP, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 48 hours||2.066|0.723|0.7859
72343450|NCT01597635|144210687|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.9||||0.6058|TWO_SIDED|95.0|0.413|1.963|||Bayesian repeated measures model|||CRP, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 72 hours||1.963|0.413|0.6058
72343451|NCT01597635|144210687|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.29||||0.6921|TWO_SIDED|95.0|0.456|3.632|||Ratio of Active/Placebo|||CRP, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 72 hours||3.632|0.456|0.6921
72343452|NCT01597635|144210688|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.92||||0.7934|TWO_SIDED|95.0|0.737|1.14|||Bayesian repeated measures model|||CCP-16, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 12 hours||1.140|0.737|0.7934
72343453|NCT01597635|144210688|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.01||||0.5205|TWO_SIDED|95.0|0.782|1.317|||Bayesian repeated measures model|||CCP-16, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 24 hours||1.317|0.782|0.5205
72343454|NCT01597635|144210688|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.12||||0.6682|TWO_SIDED|95.0|0.673|1.865|||Bayesian repeated measures model|||CCP-16, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 48 hours||1.865|0.673|0.6682
72343455|NCT01597635|144210688|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.99||||0.5304|TWO_SIDED|95.0|0.744|1.315|||Bayesian repeated measures model|||CCP-16, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 72 hours||1.315|0.744|0.5304
72343456|NCT01597635|144210688|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.81||||0.9078|TWO_SIDED|95.0|0.582|1.112|||Bayesian repeated measures model|||CCP-16, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 120 hours||1.112|0.582|0.9078
72343457|NCT01597635|144210688|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.26||||0.9907|TWO_SIDED|95.0|1.042|1.526|||Bayesian repeated measures model|||SP-D, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 12 hours||1.526|1.042|0.9907
72343458|NCT01597635|144210688|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.27||||0.9973|TWO_SIDED|95.0|1.005|1.606|||Bayesian repeated measures model|||SP-D, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 24 hours||1.606|1.005|0.9973
72343459|NCT01597635|144210688|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.61||||0.9954|TWO_SIDED|95.0|1.13|2.331|||Bayesian repeated measures model|||SP-D, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 48 hours||2.331|1.130|0.9954
72343460|NCT01597635|144210688|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.65||||0.983|TWO_SIDED|95.0|1.045|2.588|||Bayesian repeated measures model|||SP-D, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 72 hours||2.588|1.045|0.9830
72343461|NCT01597635|144210688|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.52||||0.9312|TWO_SIDED|95.0|0.867|2.737|||Bayesian repeated measures model|||SP-D, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 120 hours||2.737|0.867|0.9312
72343462|NCT03416127|144210703|OTHER|||||||0.031|||||||Kruskal-Wallis|||||||0.031
72343463|NCT03416127|144210704|OTHER|||||||0.963|||||||Kruskal-Wallis|||||||0.963
72343464|NCT03416127|144210705|OTHER|||||||0.236|||||||Kruskal-Wallis|||||||0.236
72343465|NCT03416127|144210706|OTHER|||||||0.015|||||||Kruskal-Wallis|||||||0.015
72343466|NCT03416127|144210707|OTHER|||||||0.017|||||||Kruskal-Wallis|||||||0.017
72343467|NCT03416127|144210708|OTHER|||||||0.162|||||||Kruskal-Wallis|||||||0.162
72343468|NCT03416127|144210709|OTHER|||||||0.686|||||||Kruskal-Wallis|||||||0.686
72343469|NCT03416127|144210710|OTHER|||||||0.004|||||||Kruskal-Wallis|||||||0.004
72343470|NCT03416127|144210711|OTHER|||||||0.945|||||||Kruskal-Wallis|||||||0.945
72343471|NCT03416127|144210712|OTHER|||||||0.332|||||||Kruskal-Wallis|||||||0.332
72343472|NCT03416127|144210713|OTHER|||||||0.075|||||||Kruskal-Wallis|||||||0.075
72343473|NCT03416127|144210714|OTHER|||||||0.903|||||||Kruskal-Wallis|||||||0.903
72343474|NCT03416127|144210715|OTHER|||||||0.697|||||||Kruskal-Wallis|||||||0.697
72343475|NCT03416127|144210716|OTHER|||||||0.668|||||||Kruskal-Wallis|||||||0.668
72343476|NCT03416127|144210717|OTHER|||||||0.308|||||||Kruskal-Wallis|||||||0.308
72343477|NCT03416127|144210718|OTHER|||||||0.318|||||||Kruskal-Wallis|||||||0.318
72343478|NCT03416127|144210719|OTHER|||||||0.88|||||||Kruskal-Wallis|||||||0.880
72343479|NCT03416127|144210720|OTHER|||||||0.376|||||||Kruskal-Wallis|||||||0.376
72343480|NCT03416127|144210721|OTHER|||||||0.21|||||||Kruskal-Wallis|||||||0.210
72343481|NCT03416127|144210722|OTHER|||||||0.88|||||||Kruskal-Wallis|||||||0.880
72343482|NCT03416127|144210723|OTHER|||||||0.059|||||||Kruskal-Wallis|||||||0.059
72343483|NCT03416127|144210724|OTHER|||||||0.978|||||||Kruskal-Wallis|||||||0.978
72343484|NCT03416127|144210725|OTHER|||||||0.122|||||||Kruskal-Wallis|||||||0.122
72343485|NCT03416127|144210726|OTHER|||||||0.551|||||||Kruskal-Wallis|||||||0.551
72343486|NCT01963845|144210727|SUPERIORITY_OR_OTHER|||||||0.585|||||||t-test, 2 sided|||||||0.585
72343487|NCT01963845|144210728|SUPERIORITY_OR_OTHER|||||||0.7583|||||||Wilcoxon (Mann-Whitney)|||Comparison of change in AST values from baseline to 24 weeks between the two groups.||||0.7583
72343488|NCT01963845|144210729|SUPERIORITY_OR_OTHER|||||||0.8569|||||||Wilcoxon (Mann-Whitney)|||Comparison of change in ALT values from baseline to 24 weeks between the two groups.||||0.8569
72343489|NCT01963845|144210730|SUPERIORITY_OR_OTHER|||||||0.7984|||||||Wilcoxon (Mann-Whitney)|||Comparison of change in LDL values from baseline to 24 weeks between the two groups.||||0.7984
72343490|NCT01963845|144210731|SUPERIORITY_OR_OTHER|||||||0.556|||||||Wilcoxon (Mann-Whitney)|||Comparison of change in HOMA-IR values from baseline to 24 weeks between the two groups.||||0.5560
72343491|NCT00767806|144210732|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||Mixed Models Analysis|||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the Brief Pain Inventory 24-hour average pain score after 12 weeks of treatment.||||0.001
72428659|NCT01755689|144368337|NON_INFERIORITY|The non-inferiority criteria: the UL of the 2-sided standardised asymptotic 95% CI for the ratio of rSBA GMTs had to be below the pre-defined limit of 2.|Adjusted GMT Ratio|1.26|||||TWO_SIDED|95.0|0.97|1.64|||ANCOVA|||Adjusted GMT ratio of the Nimenrix Group versus Nimenrix+Cervarix+Boostrix Group in terms of rSBA-MenW-135 titers.||1.64|0.97|
72343492|NCT00767806|144210733|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.68||||0.002|TWO_SIDED|95.0|-1.12|-0.25||P-value is for BPI severity of worst pain - change|ANCOVA|Main effect model: Change = Treatment + Investigator + Baseline (Type III sums of square)||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the Brief Pain Inventory severity of worst pain score during 12 weeks of treatment.||-0.25|-1.12|0.002
72343493|NCT00767806|144210733|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.49||||0.006|TWO_SIDED|95.0|-0.85|-0.14||P-value is for BPI severity of least pain - change|ANCOVA|Main effect model: Change = Treatment + Investigator + Baseline (Type III sums of square)||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the Brief Pain Inventory severity of least pain score during 12 weeks of treatment.||-0.14|-0.85|0.006
72343494|NCT00767806|144210733|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.86|||<|0.001|TWO_SIDED|95.0|-1.25|-0.46||P-value is for BPI severity of pain right now - change|ANCOVA|Main effect model: Change = Treatment + Investigator + Baseline (Type III sums of square)||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the Brief Pain Inventory severity of pain right now score during 12 weeks of treatment.||-0.46|-1.25|<0.001
72343495|NCT00767806|144210733|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.75|||<|0.001|TWO_SIDED|95.0|-1.16|-0.35||P-value is for BPI interference with general activity - change|ANCOVA|Main Effect Model: Change = Treatment + Investigator + Baseline (Type III sums of squares)||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the Brief Pain Inventory interference with general activity score during 12 weeks of treatment.||-0.35|-1.16|<0.001
72343496|NCT00767806|144210733|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.71|||<|0.001|TWO_SIDED|95.0|-1.09|-0.34||P-value is for BPI interference with mood score - change|ANCOVA|Main Effect Model: Change = Treatment + Investigator + Baseline (Type III sums of squares)||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the Brief Pain Inventory interference with mood score during 12 weeks of treatment.||-0.34|-1.09|<0.001
72343497|NCT00767806|144210733|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.46||||0.02|TWO_SIDED|95.0|-0.84|-0.07||P-value is for BPI interference with walking ability - change|ANCOVA|Main Effect Model: Change = Treatment + Investigator + Baseline (Type III sums of squares)||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the Brief Pain Inventory interference with walking ability score during 12 weeks of treatment.||-0.07|-0.84|0.020
72343498|NCT00767806|144210733|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.51||||0.012|TWO_SIDED|95.0|-0.9|-0.11||P-value is for BPI interference with normal work - change|ANCOVA|Main Effect Model: Change = Treatment + Investigator + Baseline (Type III sums of squares)||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the Brief Pain Inventory interference with normal work score during 12 weeks of treatment.||-0.11|-0.90|0.012
72343499|NCT00767806|144210733|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.57||||0.001|TWO_SIDED|95.0|-0.92|-0.22||P-value is for BPI interference with relations to others - change|ANCOVA|Main Effect Model: Change = Treatment + Investigator + Baseline (Type III sums of squares)||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the Brief Pain Inventory interference with relations to others score during 12 weeks of treatment.||-0.22|-0.92|0.001
72343500|NCT00767806|144210733|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7||||0.002|TWO_SIDED|95.0|-1.13|-0.27||P-value is for BPI interference with sleep score - change|ANCOVA|Main Effect Model: Change = Treatment + Investigator + Baseline (Type III sums of squares)||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the Brief Pain Inventory interference with sleep score during 12 weeks of treatment.||-0.27|-1.13|0.002
72343501|NCT00767806|144210733|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.57||||0.005|TWO_SIDED|95.0|-0.96|-0.18||P-value is for BPI interference with enjoyment of life score - change|ANCOVA|Main Effect Model: Change = Treatment + Investigator + Baseline (Type III sums of squares)||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the Brief Pain Inventory interference with enjoyment of life score during 12 weeks of treatment.||-0.18|-0.96|0.005
72343502|NCT00767806|144210733|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.58|||<|0.001|TWO_SIDED|95.0|-0.92|-0.25||P-value is for BPI average interference score - change|ANCOVA|Main Effect Model: Change = Treatment + Investigator + Baseline (Type III sums of squares)||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the Brief Pain Inventory average interference score during 12 weeks of treatment.||-0.25|-0.92|<0.001
72343503|NCT00767806|144210734|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7|||<|0.001|TWO_SIDED|95.0|-1.05|-0.35||p-value is for weekly 24-hour average pain rating score - change|ANCOVA|Main Effect Model: Change = Treatment + Investigator + Baseline (Type III sums of squares)||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the weekly 24-hour average pain rating score during 12 weeks of treatment.||-0.35|-1.05|<0.001
72343504|NCT00767806|144210734|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.71|||<|0.001|TWO_SIDED|95.0|-1.08|-0.33||p-value is for weekly 24-hour worst pain score - change|ANCOVA|Main Effect Model: Change = Treatment + Investigator + Baseline (Type III sums of squares)||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the weekly 24-hour worst pain score during 12 weeks of treatment.||-0.33|-1.08|<0.001
72343505|NCT00767806|144210734|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.52||||0.004|TWO_SIDED|95.0|-0.87|-0.17||p-value is for weekly 24-hour night pain score - change|ANCOVA|Main Effect Model: Change = Treatment + Investigator + Baseline (Type III sums of squares)||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the weekly 24-hour night pain score during 12 weeks of treatment.||-0.17|-0.87|0.004
72343506|NCT00767806|144210735|SUPERIORITY_OR_OTHER|||||||0.108||95.0||||p-value is for number of patients who achieve a \>=30% reduction of the Brief Pain Inventory average pain severity rating - difference between placebo and duloxetine|Fisher Exact|||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in number of patients who achieve a \>=30% reduction of the Brief Pain Inventory average pain severity rating after 12 weeks of treatment.||||0.108
72343507|NCT00767806|144210736|SUPERIORITY_OR_OTHER|||||||0.006||95.0||||p-value is for number of patients who achieve a \>=50% reduction of the Brief Pain Inventory average pain severity rating - difference between placebo and duloxetine|Fisher Exact|||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in number of patients who achieve a \>=50% reduction of the Brief Pain Inventory average pain severity rating after 12 weeks of treatment.||||0.006
72343508|NCT00767806|144210737|SUPERIORITY_OR_OTHER|||||||0.082||95.0||||p-value is difference between duloxetine and placebo in number of patients who achieve criteria described in null hypothesis|Fisher Exact|||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in number of patients who achieve a \>=30% reduction of the Brief Pain Inventory (BPI) average pain severity rating from baseline to endpoint and baseline to earlier visit than last visit and maintains a \>=20% reduction of BPI average pain rating from baseline at every visit.||||0.082
72343509|NCT00767806|144210738|SUPERIORITY_OR_OTHER|||||||0.013||95.0||||p-value is for difference between duloxetine and placebo groups in the empirical overall cumulated distribution of the percentage pain reduction|Kolnogorov-Smirnov test|||Tested was the null hypothesis that there is no difference between duloxetine and placebo groups in the empirical cumulated distribution of the percentage pain reduction.||||0.013
72343510|NCT00767806|144210739|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.16||||0.077|TWO_SIDED|95.0|-0.33|0.02||p-value is for difference between placebo and duloxetine groups in change of the Clinical Global Impression of Severity score|ANCOVA|Main Effect Model: Change = Treatment + Investigator + Baseline (Type III sums of squares)||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the Clinical Global Impression of Severity score after 12 weeks of treatment.||0.02|-0.33|0.077
72343511|NCT00767806|144210740|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.31||||0.011|TWO_SIDED|95.0|-0.56|-0.07||p-value is for difference between placebo and duloxetine groups Patient's Global Impression of Improvement endpoint value|ANCOVA|Main Effect Model: PGI-I=Treatment+Investigator+Baseline(Type III sums of squares). PGI-Severity score from baseline visit was used as the baseline.||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups Patient's Global Impression of Improvement endpoint value during 12 weeks of treatment.||-0.07|-0.56|0.011
72343512|NCT00767806|144210741|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.47||||0.255|TWO_SIDED|95.0|-1.28|0.34||p-value is for difference between placebo and duloxetine groups in change of the Roland Morris Disability Questionnaire total score|ANCOVA|Main Effect Model: Change = Treatment + Investigator + Baseline (Type III sums of squares)||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the Roland Morris Disability Questionnaire total score during 12 weeks of treatment.||0.34|-1.28|0.255
72343513|NCT00767806|144210742|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.88|||<|0.001|TWO_SIDED|95.0|-1.38|-0.37||p-value is for difference between placebo and duloxetine groups in change of the Profile of Mood States Tension-Anxiety subscore|ANCOVA|Main Effect Model: Change = Treatment + Investigator + Baseline (Type III sums of squares)||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the Profile of Mood States Tension-Anxiety subscore during 12 weeks of treatment.||-0.37|-1.38|<0.001
72343514|NCT00767806|144210742|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.39||||0.133|TWO_SIDED|95.0|-0.9|0.12||p-value is for difference between placebo and duloxetine groups in change of the Profile of Mood States Depression-Dejection subscore|ANCOVA|Main Effect Model: Change = Treatment + Investigator + Baseline (Type III sums of squares)||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the Profile of Mood States Depression-Dejection subscore during 12 weeks of treatment.||0.12|-0.90|0.133
72343515|NCT00767806|144210742|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.92|||<|0.001|TWO_SIDED|95.0|-1.46|-0.37||p-value is for difference between placebo and duloxetine groups in change of the Profile of Mood States Anger-Hostility score|ANCOVA|Main Effect Model: Change = Treatment + Investigator + Baseline (Type III sums of squares)||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the Profile of Mood States Anger-Hostility score during 12 weeks of treatment.||-0.37|-1.46|<0.001
72370077|NCT04173494|144250582|OTHER||Stratified CMH|6.97||||0.2844|TWO_SIDED|95.0|-5.41|19.35|||Cochran-Mantel-Haenszel||\>=2g/dL Increase in Hemoglobin response|||19.35|-5.41|0.2844
72370078|NCT04173494|144250587|OTHER||Hazard Ratio (HR)|0.89||||0.6879|TWO_SIDED|95.0|0.504|1.572|||Log Rank|||||1.572|0.504|0.6879
72370079|NCT04173494|144250588|OTHER||Hazard Ratio (HR)|0.804||||0.432|TWO_SIDED|95.0|0.466|1.386|||Log Rank|||||1.386|0.466|0.4320
72370080|NCT04173494|144250589|OTHER||Least Squares Mean Difference|-0.71||||0.0513|TWO_SIDED|95.0|-1.42|0.0|||MMRM|||||0.00|-1.42|0.0513
72343516|NCT00767806|144210742|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.13||||0.003|TWO_SIDED|95.0|0.38|1.88||p-value is for difference between placebo and duloxetine groups in change of the Profile of Mood States Vigor-Activity score|ANCOVA|Main Effect Model: Change = Treatment + Investigator + Baseline (Type III sums of squares)||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the Profile of Mood States Vigor-Activity score during 12 weeks of treatment.||1.88|0.38|0.003
72343517|NCT00767806|144210742|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.25||||0.469|TWO_SIDED|95.0|-0.93|0.43||p-value is for difference between placebo and duloxetine groups in change of the Profile of Mood States Fatigue-Inertia score|ANCOVA|Main Effect Model: Change = Treatment + Investigator + Baseline (Type III sums of squares)||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the Profile of Mood States Fatigue-Inertia score during 12 weeks of treatment.||0.43|-0.93|0.469
72343518|NCT00767806|144210742|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.57||||0.006|TWO_SIDED|95.0|-0.98|-0.17||p-value is for difference between placebo and duloxetine groups in change of the Profile of Mood States Confusion-Bewilderment score|ANCOVA|Main Effect Model: Change = Treatment + Investigator + Baseline (Type III sums of squares)||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the Profile of Mood States Confusion-Bewilderment score during 12 weeks of treatment.||-0.17|-0.98|0.006
72343519|NCT00767806|144210742|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.0||||0.001|TWO_SIDED|95.0|-6.41|-1.6||p-value is for difference between placebo and duloxetine groups in change of the Profile of Mood States Total Mood Disturbance score|ANCOVA|Main Effect Model: Change = Treatment + Investigator + Baseline (Type III sums of squares)||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the Profile of Mood States Total Mood Disturbance score during 12 weeks of treatment.||-1.60|-6.41|0.001
72343520|NCT00767806|144210743|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.24||||0.168|TWO_SIDED|95.0|-0.53|3.02||p-value is for difference between placebo and duloxetine groups in change of the 36-SF Health Survey Physical Component score|ANCOVA|Main Effect Model: Change = Treatment + Investigator + Baseline (Type III sums of squares)||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the 36-SF Health Survey Physical Component score during 12 weeks of treatment.||3.02|-0.53|0.168
72343521|NCT00767806|144210743|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.24||||0.01|TWO_SIDED|95.0|0.53|3.96||p-value is for difference between placebo and duloxetine groups in change of the SF-36 Health Survey Mental Component score|ANCOVA|Main Effect Model: Change = Treatment + Investigator + Baseline (Type III sums of squares)||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the SF-36 Health Survey Mental Component score during 12 weeks of treatment.||3.96|0.53|0.010
72343522|NCT00767806|144210743|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.58||||0.016|TWO_SIDED|95.0|0.86|8.3||p-value is for difference between placebo and duloxetine groups in change of the SF-36 Health Survey Bodily Pain Transformed score|ANCOVA|Main Effect Model: Change = Treatment + Investigator + Baseline (Type III sums of squares)||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the SF-36 Health Survey Bodily Pain Transformed score during 12 weeks of treatment.||8.30|0.86|0.016
72343523|NCT00767806|144210743|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.88|||<|0.001|TWO_SIDED|95.0|2.15|7.61||p-value is for difference between placebo and duloxetine groups in change of the SF-36 Health Survey Mental Health Transformed score|ANCOVA|Main Effect Model: Change = Treatment + Investigator + Baseline (Type III sums of squares)||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the SF-36 Health Survey Mental Health Transformed score during 12 weeks of treatment.||7.61|2.15|<0.001
72343524|NCT00767806|144210743|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.58||||0.101|TWO_SIDED|95.0|-0.5|5.67||p-value is for difference between placebo and duloxetine groups in change of the SF-36 Health Survey General Health Transformed score|ANCOVA|Main Effect Model: Change = Treatment + Investigator + Baseline (Type III sums of squares)||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the SF-36 Health Survey General Health Transformed score during 12 weeks of treatment.||5.67|-0.50|0.101
72343525|NCT00767806|144210743|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.5||||0.058|TWO_SIDED|95.0|-0.12|7.12||p-value is for difference between placebo and duloxetine groups in change of the SF-36 Health Survey Physical Functioning Transformed score|ANCOVA|Main Effect Model: Change = Treatment + Investigator + Baseline (Type III sums of squares)||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the SF-36 Health Survey Physical Functioning Transformed score during 12 weeks of treatment.||7.12|-0.12|0.058
72343526|NCT00767806|144210743|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.43||||0.227|TWO_SIDED|95.0|-1.52|6.37||p-value is for difference between placebo and duloxetine groups in change of the SF-36 Health Survey Role-Emotional Transformed score|ANCOVA|Main Effect Model: Change = Treatment + Investigator + Baseline (Type III sums of squares)||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the SF-36 Health Survey Role-Emotional Transformed score during 12 weeks of treatment.||6.37|-1.52|0.227
72343527|NCT00767806|144210743|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.91||||0.383|TWO_SIDED|95.0|-2.39|6.21||p-value is for difference between placebo and duloxetine groups in change of the SF-36 Health Survey Role-Physical Transformed score|ANCOVA|Main Effect Model: Change = Treatment + Investigator + Baseline (Type III sums of squares)||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the SF-36 Health Survey Role-Physical Transformed score during 12 weeks of treatment.||6.21|-2.39|0.383
72343528|NCT00767806|144210743|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.0||||0.03|TWO_SIDED|95.0|0.38|7.61||p-value is for difference between placebo and duloxetine groups in change of the SF-36 Health Survey Social Functioning Transformed score|ANCOVA|Main Effect Model: Change = Treatment + Investigator + Baseline (Type III sums of squares)||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the SF-36 Health Survey Social Functioning Transformed score during 12 weeks of treatment.||7.61|0.38|0.030
72370081|NCT04173494|144250590|OTHER||Least Squares Mean Difference|-10.82||||0.0113|TWO_SIDED|95.0|-19.15|-2.48|||MMRM|||||-2.48|-19.15|0.0113
72343529|NCT00767806|144210743|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.1||||0.022|TWO_SIDED|95.0|0.59|7.6||p-value is for difference between placebo and duloxetine groups in change of the SF-36 Health Survey Vitality Transformed score|ANCOVA|Main Effect Model: Change = Treatment + Investigator + Baseline (Type III sums of squares)||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the SF-36 Health Survey Vitality Transformed score during 12 weeks of treatment.||7.60|0.59|0.022
72343530|NCT00767806|144210744|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.07|||<|0.001|TWO_SIDED|95.0|0.03|0.12||p-value is for difference between placebo and duloxetine groups in change of the European Quality of Life Questionnaire - 5 Dimension - United Kingdom population-based Index score|ANCOVA|Main Effect Model: Change = Treatment + Investigator (Type III sums of squares)||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the European Quality of Life Questionnaire - 5 Dimension - United Kingdom population-based Index score during 12 weeks of treatment.||0.12|0.03|<0.001
72343531|NCT00767806|144210744|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.05||||0.002|TWO_SIDED|95.0|0.02|0.08||p-value is for difference between placebo and duloxetine groups in change of the European Quality of Life Questionnaire - 5 Dimension - United States population-based index score|ANCOVA|Main Effect Model: Change = Treatment + Investigator + Baseline (Type III sums of squares)||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the European Quality of Life Questionnaire - 5 Dimension - United States population-based index score during 12 weeks of treatment.||0.08|0.02|0.002
72370082|NCT04173494|144250591|OTHER||Least Squares Mean Difference|1.31||||0.357|TWO_SIDED|95.0|-1.49|4.11|||MMRM|||||4.11|-1.49|0.3570
72370083|NCT03656380|144250592|SUPERIORITY|||||||0.14|||||||ANCOVA|||||||0.14
72370084|NCT03656380|144250593|SUPERIORITY|||||||0.95|||||||Chi-squared|||||||0.95
72370085|NCT03656380|144250594|SUPERIORITY|||||||0.2|||||||Chi-squared|||||||0.20
72370086|NCT03656380|144250595|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
72370087|NCT03656380|144250596|SUPERIORITY||||||<|0.001|||||||Chi-squared|||\<15 eos/hpf||||<0.001
72370088|NCT03656380|144250596|SUPERIORITY|||||||0.02|||||||Chi-squared|||≤6 eos/hpf||||0.02
72370089|NCT03656380|144250596|SUPERIORITY|||||||0.27|||||||Chi-squared|||≤1 eos/hpf||||0.27
72370090|NCT03656380|144250597|SUPERIORITY|||||||0.03|||||||ANCOVA|||||||0.03
72370091|NCT03656380|144250598|SUPERIORITY|||||||0.44|||||||ANCOVA|||||||0.44
72370092|NCT01485172|144250623|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.33||||0.864|TWO_SIDED|95.0|-3.41|4.05||P-values are from a Mixed Model Repeated Measures analysis.|Mixed Models Analysis|||||4.05|-3.41|0.864
72370093|NCT01485172|144250623|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.85||||0.539|TWO_SIDED|95.0|-3.61|1.9||P-values are from a Mixed Model Repeated Measures analysis.|Mixed Models Analysis|||||1.90|-3.61|0.539
72370094|NCT01485172|144250623|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.4||||0.091|TWO_SIDED|95.0|-5.21|0.39||P-values are from a Mixed Model Repeated Measures analysis.|Mixed Models Analysis|||||0.39|-5.21|0.091
72370095|NCT01485172|144250623|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.16||||0.124|TWO_SIDED|95.0|-4.93|0.6||P-values are from a Mixed Model Repeated Measures analysis.|Mixed Models Analysis|||||0.60|-4.93|0.124
72370096|NCT01485172|144250623|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.92||||0.658|TWO_SIDED|95.0|-5.04|3.19||P-values are from a Mixed Model Repeated Measures analysis.|Mixed Models Analysis|||||3.19|-5.04|0.658
72370097|NCT01485172|144250623|SUPERIORITY_OR_OTHER|||||||0.439||95.0||||P-values are from nonparametric rank ANCOVA without stratifications.|ANCOVA|||||||0.439
72370098|NCT01485172|144250623|SUPERIORITY_OR_OTHER|||||||0.177||95.0||||P-values are from nonparametric rank ANCOVA without stratifications.|ANCOVA|||||||0.177
72370099|NCT01485172|144250623|SUPERIORITY_OR_OTHER|||||||0.06||95.0||||P-values are from nonparametric rank ANCOVA without stratifications.|ANCOVA|||||||0.060
72370100|NCT01485172|144250623|SUPERIORITY_OR_OTHER|||||||0.047||95.0||||P-values are from nonparametric rank ANCOVA without stratifications.|ANCOVA|||||||0.047
72370101|NCT01485172|144250623|SUPERIORITY_OR_OTHER|||||||0.407||95.0||||P-values are from nonparametric rank ANCOVA without stratifications.|ANCOVA|||||||0.407
72370102|NCT01485172|144250624|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.003||||0.397|TWO_SIDED|95.0|0.4|9.98|||Generalized Estimating Equations model|||||9.98|0.40|0.397
72370103|NCT01485172|144250624|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.242||||0.131|TWO_SIDED|95.0|0.79|6.4|||Generalized Estimating Equations model|||||6.40|0.79|0.131
72370104|NCT01485172|144250624|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.515||||0.018|TWO_SIDED|95.0|1.25|9.92|||Generalized Estimating Equations model|||||9.92|1.25|0.018
72370105|NCT01485172|144250624|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.607||||0.02||95.0|1.22|10.64|||Generalized Estimating Equations model|||||10.64|1.22|0.020
72370106|NCT01485172|144250624|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.679||||0.202|TWO_SIDED|95.0|0.59|12.16|||Generalized Estimating Equations model|||||12.16|0.59|0.202
72370107|NCT01485172|144250625|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.544||||0.662||95.0|0.22|10.84|||Generalized Estimating Equations model|||||10.84|0.22|0.662
72370108|NCT01485172|144250625|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.485||||0.557|TWO_SIDED|95.0|0.4|5.55|||Generalized Estimating Equations model|||||5.55|0.40|0.557
72370109|NCT01485172|144250625|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.855||||0.347|TWO_SIDED|95.0|0.51|6.72|||Generalized Estimating Equations model|||||6.72|0.51|0.347
72370110|NCT01485172|144250625|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.776||||0.379|TWO_SIDED|95.0|0.49|6.38|||Generalized Estimating Equations model|||||6.38|0.49|0.379
72370111|NCT01485172|144250625|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.194||||0.851|TWO_SIDED|95.0|0.19|7.63|||Generalized Estimating Equations model|||||7.63|0.19|0.851
72370112|NCT01485172|144250627|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.591||||0.54|TWO_SIDED|95.0|0.36|7.03|||Generalized Estimating Equations model|||||7.03|0.36|0.540
72370113|NCT01485172|144250627|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.473||||0.494|TWO_SIDED|95.0|0.49|4.47|||Generalized Estimating Equations model|||||4.47|0.49|0.494
72370114|NCT01485172|144250627|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.391||||0.115|TWO_SIDED|95.0|0.81|7.06|||Generalized Estimating Equations model|||||7.06|0.81|0.115
72428660|NCT01755689|144368337|NON_INFERIORITY|The non-inferiority criteria: the UL of the 2-sided standardised asymptotic 95% CI for the ratio of rSBA GMTs had to be below the pre-defined limit of 2.|Adjusted GMT Ratio|0.82|||||TWO_SIDED|95.0|0.63|1.07|||ANCOVA|||Adjusted GMT ratio of the Nimenrix Group versus Nimenrix+Cervarix Group in terms of rSBA-MenW-135 titers.||1.07|0.63|
72428661|NCT01755689|144368337|NON_INFERIORITY|The non-inferiority criteria: the UL of the 2-sided standardised asymptotic 95% CI for the ratio of rSBA GMTs had to be below the pre-defined limit of 2.|Adjusted GMT Ratio|1.05|||||TWO_SIDED|95.0|0.89|1.24|||ANCOVA|||Adjusted GMT ratio of the Nimenrix Group versus Nimenrix+Cervarix+Boostrix Group in terms of rSBA-MenY titers.||1.24|0.89|
72343532|NCT00767806|144210745|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.02||||0.461|TWO_SIDED|95.0|-0.03|0.06||p-value is for difference between placebo and duloxetine groups in change of the Work Productivity and Activity Impairment Instrument (WPAI) - Absenteeism score|ANCOVA|Main Effect Model: Change = Treatment + Investigator + Baseline (Type III sums of squares)||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the Work Productivity and Activity Impairment Instrument (WPAI) - Absenteeism score during 12 weeks of treatment.||0.06|-0.03|0.461
72343533|NCT00767806|144210745|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.03||||0.374|TWO_SIDED|95.0|-0.09|0.03||p-value is for difference between placebo and duloxetine groups in change of the Work Productivity and Activity Impairment Instrument (WPAI) - Presenteeism score|ANCOVA|||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the Work Productivity and Activity Impairment Instrument (WPAI) - Presenteeism score during 12 weeks of treatment.||0.03|-0.09|0.374
72343534|NCT00767806|144210745|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02||||0.557|TWO_SIDED|95.0|-0.09|0.05||p-value is for difference between placebo and duloxetine groups in change of the Work Productivity and Activity Impairment Instrument (WPAI) - Work Productivity Loss score|ANCOVA|||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the Work Productivity and Activity Impairment Instrument (WPAI) - Work Productivity Loss score during 12 weeks of treatment.||0.05|-0.09|0.557
72343535|NCT00767806|144210745|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.06||||0.007|TWO_SIDED|95.0|-0.1|-0.02||p-value is for difference between placebo and duloxetine groups in change of the Work Productivity and Activity Impairment Instrument (WPAI) - Activity Impairment score|ANCOVA|||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the Work Productivity and Activity Impairment Instrument (WPAI) - Activity Impairment score during 12 weeks of treatment.||-0.02|-0.10|0.007
72343536|NCT00767806|144210747|SUPERIORITY_OR_OTHER|||||||0.01||95.0||||p-value is for difference between placebo and duloxetine groups in uric acid - change|ANOVA|Change Variable = Treatment + Investigator (Type III sums of squares). Rank-transformed change was used as change variable in the ANOVA model.||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of uric acid during 12 weeks of treatment.||||0.010
72343537|NCT00767806|144210748|SUPERIORITY_OR_OTHER|||||||0.031||95.0||||p-value is for difference between duloxetine and placebo in albumin - change|ANOVA|||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of Albumin during 12 weeks of treatment.||||0.031
72343538|NCT00767806|144210749|SUPERIORITY_OR_OTHER|||||||0.004||95.0||||p-value is for difference between duloxetine and placebo in alkaline phosphatase - change|ANOVA|||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of alkaline phosphatase during 12 weeks of treatment.||||0.004
72343539|NCT00767806|144210750|SUPERIORITY_OR_OTHER|||||||0.013||95.0||||p-value is for difference between duloxetine and placebo in alanine aminotransferase - change|ANOVA|||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of Alanine Aminotransferase during 12 weeks of treatment.||||0.013
72343540|NCT00767806|144210751|SUPERIORITY_OR_OTHER|||||||0.039||95.0||||p-value for difference between duloxetine and placebo in aspartate aminotransferase - change|ANOVA|||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of aspartate aminotransferase during 12 weeks of treatment.||||0.039
72343541|NCT00767806|144210752|SUPERIORITY_OR_OTHER|||||||0.024||95.0||||p-value is for difference between duloxetine and placebo in creatinine - change|ANOVA|||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of creatinine during 12 weeks of treatment.||||0.024
72343542|NCT00767806|144210753|SUPERIORITY_OR_OTHER|||||||0.019||95.0||||p-value is for difference between duloxetine and placebo in total protein - change|ANOVA|||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of total protein during 12 weeks of treatment.||||0.019
72428662|NCT01755689|144368337|NON_INFERIORITY|The non-inferiority criteria: the UL of the 2-sided standardised asymptotic 95% CI for the ratio of rSBA GMTs had to be below the pre-defined limit of 2.|Adjusted GMT Ratio|0.95|||||TWO_SIDED|95.0|0.8|1.12|||ANCOVA|||Adjusted GMT ratio of the Nimenrix Group versus Nimenrix+Cervarix Group in terms of rSBA-MenY titers.||1.12|0.80|
72343543|NCT00767806|144210754|SUPERIORITY_OR_OTHER|||||||0.329||95.0||||p-value is for difference between placebo and duloxetine groups in change of systolic blood pressure|ANOVA|Main Effect Model: Change = Treatment + Investigator (Type III sums of squares)||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of systolic blood pressure during 12 weeks of treatment.||||0.329
72343544|NCT00767806|144210754|SUPERIORITY_OR_OTHER|||||||0.562||95.0||||p-value is for difference between placebo and duloxetine groups in change of diastolic blood pressure|ANOVA|Main Effect Model: Change = Treatment + Investigator (Type III sums of squares)||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of diastolic blood pressure during 12 weeks of treatment.||||0.562
72428663|NCT01755689|144368338|NON_INFERIORITY|For HPV-16, one month after the third dose of Cervarix, the UL of the two-sided standardized asymptotic 95% CI on the group GMT ratio had to be below the pre-defined limit of 2.|Adjusted GMT|0.97|||||TWO_SIDED|95.0|0.81|1.15|||ANCOVA|||Adjusted GMT ratio of the Cervarix Group versus Nimenrix+Cervarix (0,1,6-Month) Group in terms of HPV-16 titers.||1.15|0.81|
72343545|NCT00767806|144210756|SUPERIORITY_OR_OTHER|||||||0.68||95.0||||p-value is for difference between duloxetine and placebo in pulse rate - change|ANOVA|||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of pulse rate during 12 weeks of treatment.||||0.680
72343546|NCT00858208|144210761|SUPERIORITY_OR_OTHER|||||||0.0072|TWO_SIDED||||||paired t-test|||||||0.0072
72343547|NCT00858208|144210762|SUPERIORITY_OR_OTHER|||||||0.0433|TWO_SIDED||||||paired t-test|||Change from baseline at Week 6||||0.0433
72343548|NCT00858208|144210762|SUPERIORITY_OR_OTHER|||||||0.0133|TWO_SIDED||||||paired t-test|||Change from baseline at Week 12||||0.0133
72343549|NCT00858208|144210762|SUPERIORITY_OR_OTHER|||||||0.0278|TWO_SIDED||||||paired t-test|||Change from baseline at Week 18||||0.0278
72343550|NCT00858208|144210762|SUPERIORITY_OR_OTHER|||||||0.016|TWO_SIDED||||||paired t-test|||Change from baseline at Week 24||||0.0160
72343551|NCT00858208|144210762|SUPERIORITY_OR_OTHER|||||||0.0264|TWO_SIDED||||||paired t-test|||Change from baseline at Week 30||||0.0264
72343552|NCT00858208|144210762|SUPERIORITY_OR_OTHER|||||||0.0278|TWO_SIDED||||||paired t-test|||Change from baseline at Week 36||||0.0278
72343553|NCT00858208|144210762|SUPERIORITY_OR_OTHER|||||||0.1854|TWO_SIDED||||||paired t-test|||Change from baseline at Week 42||||0.1854
72343554|NCT00858208|144210762|SUPERIORITY_OR_OTHER|||||||0.1684|TWO_SIDED||||||paired t-test|||Change from baseline at Week 48||||0.1684
72343555|NCT00858208|144210762|SUPERIORITY_OR_OTHER|||||||0.4718|TWO_SIDED||||||paired t-test|||Change from baseline at Week 54||||0.4718
72343556|NCT00858208|144210762|SUPERIORITY_OR_OTHER|||||||0.434|TWO_SIDED||||||paired t-test|||Change from baseline at Week 60||||0.4340
72343557|NCT00858208|144210762|SUPERIORITY_OR_OTHER|||||||0.7765|TWO_SIDED||||||paired t-test|||Change from baseline at Week 66||||0.7765
72343558|NCT00858208|144210762|SUPERIORITY_OR_OTHER|||||||0.7544|TWO_SIDED||||||paired t-test|||Change from baseline at Week 72||||0.7544
72343559|NCT00858208|144210762|SUPERIORITY_OR_OTHER|||||||0.7201|TWO_SIDED||||||paired t-test|||Change from baseline at Week 84||||0.7201
72343560|NCT00858208|144210762|SUPERIORITY_OR_OTHER|||||||0.5692|TWO_SIDED||||||paired t-test|||Change from baseline at Week 90||||0.5692
72343561|NCT00858208|144210762|SUPERIORITY_OR_OTHER|||||||0.2749|TWO_SIDED||||||paired t-test|||Change from baseline at Week 96||||0.2749
72343562|NCT00858208|144210762|SUPERIORITY_OR_OTHER|||||||0.2749|TWO_SIDED||||||paired t-test|||Change from baseline at Week 102||||0.2749
72343563|NCT00858208|144210764|SUPERIORITY_OR_OTHER|||||||0.297|TWO_SIDED||||||paired t-test|||Change at Month 6||||0.2970
72343564|NCT00858208|144210764|SUPERIORITY_OR_OTHER|||||||0.1392|TWO_SIDED||||||paired t-test|||Change at Month 12||||0.1392
72343565|NCT00858208|144210764|SUPERIORITY_OR_OTHER|||||||0.0573|TWO_SIDED||||||paired t-test|||Change at Month 18||||0.0573
72343566|NCT00858208|144210764|SUPERIORITY_OR_OTHER|||||||0.7625|TWO_SIDED||||||paired t-test|||Change at Month 24||||0.7625
72343567|NCT00858208|144210765|SUPERIORITY_OR_OTHER|||||||0.2759|TWO_SIDED||||||paired t-test|||||||0.2759
72343568|NCT02397057|144210776|OTHER|Observed cases, logistic regression analysis. Subjects with missing data on Day 42 were excluded from the statistical testing.|Odds Ratio (OR)|1.35||||0.369|TWO_SIDED|95.0|0.7|2.63||p-value was estimated by logistic regression with treatment, region (US, EUR), and baseline RLS medication-related augmentation as fixed factors, and baseline IRLS as a covariate.|Regression, Logistic|||||2.63|0.70|0.3690
72343569|NCT02397057|144210780|OTHER||Least square(LS) mean difference|-4.071|STANDARD_ERROR_OF_MEAN|2.542||0.1108|TWO_SIDED|95.0|-9.083|0.941|||ANCOVA|||LOCF, ANCOVA Analysis||0.941|-9.083|0.1108
72343570|NCT02397057|144210781|OTHER|||||||0.0002||||||p-value was estimated using continuity-corrected chi-square test.|Chi-squared, Corrected|||||||0.0002
72343571|NCT01393639|144210782|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|10.0|||||TWO_SIDED|60.0|5.0|15.0|||||Superiority criterion versus placebo: Lower bound of 60% credible interval \>20%. Non-responder imputation was used to handle dropouts at Week 8.|Bayesian 4 Parameter Emax Model Based Estimates are provided.||15|5|
72343572|NCT01393639|144210782|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|24.0|||||TWO_SIDED|60.0|18.0|31.0|||||Superiority criterion versus placebo: Lower bound of 60% credible interval \>20%. Non-responder imputation was used to handle dropouts at Week 8.|Bayesian 4 Parameter Emax Model Based Estimates are provided.||31|18|
72343573|NCT01393639|144210782|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|32.0|||||TWO_SIDED|60.0|25.0|39.0|||||Superiority criterion versus placebo: Lower bound of 60% credible interval \>20%. Non-responder imputation was used to handle dropouts at Week 8.|Bayesian 4 Parameter Emax Model Based Estimates are provided.||39|25|
72343574|NCT01393639|144210782|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|36.0|||||TWO_SIDED|60.0|29.0|43.0|||||Superiority criterion versus placebo: Lower bound of 60% credible interval \>20%. Non-responder imputation was used to handle dropouts at Week 8.|Bayesian 4 Parameter Emax Model Based Estimates are provided.||43|29|
72343575|NCT01393639|144210782|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|14.0|||||TWO_SIDED|60.0|6.0|22.0|||||Superiority criterion versus placebo: Lower bound of 60% credible interval \>20%. Non-responder imputation was used to handle dropouts at Week 8.|Bayesian 4 Parameter Emax Model Based Estimates are provided.||22|6|
72343576|NCT01393639|144210782|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|34.0|||||TWO_SIDED|60.0|27.0|42.0|||||Superiority criterion versus placebo: Lower bound of 60% credible interval \>20%. Non-responder imputation was used to handle dropouts at Week 8.|Bayesian 4 Parameter Emax Model Based Estimates are provided.||42|27|
72343577|NCT01393639|144210782|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-24.0|||||TWO_SIDED|60.0|-32.0|-17.0|||||Non inferiority criterion versus prednisone 10 mg: Lower bound of 60% credible interval \>-5%. Non-responder imputation was used to handle dropouts at Week 8.|Bayesian 4 Parameter Emax Model Based Estimates are provided.||-17|-32|
72343578|NCT01393639|144210782|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-10.0|||||TWO_SIDED|60.0|-16.0|-4.0|||||Non inferiority criterion versus prednisone 10 mg: Lower bound of 60% credible interval \>-5%. Non-responder imputation was used to handle dropouts at Week 8.|Bayesian 4 Parameter Emax Model Based Estimates are provided.||-4|-16|
72370115|NCT01485172|144250627|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.96||||0.045|TWO_SIDED|95.0|1.02|8.55|||Generalized Estimating Equations model|||||8.55|1.02|0.045
72370116|NCT01485172|144250627|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.506||||0.221|TWO_SIDED|95.0|0.58|10.9|||Generalized Estimating Equations model|||||10.90|0.58|0.221
72370117|NCT01485172|144250628|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.07||||0.662|TWO_SIDED|95.0|-3.78|5.93||P-values are from a Mixed Model Repeated Measures analysis.|Mixed Models Analysis|||||5.93|-3.78|0.662
72370118|NCT01485172|144250628|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.93||||0.621|TWO_SIDED|95.0|-4.63|2.77||P-values are from a Mixed Model Repeated Measures analysis.|Mixed Models Analysis|||||2.77|-4.63|0.621
72343579|NCT01393639|144210782|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.0|||||TWO_SIDED|60.0|-9.0|4.0|||||Non inferiority criterion versus prednisone 10 mg: Lower bound of 60% credible interval \>-5%. Non-responder imputation was used to handle dropouts at Week 8.|Bayesian 4 Parameter Emax Model Based Estimates are provided.||4|-9|
72343580|NCT01393639|144210782|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.0|||||TWO_SIDED|60.0|-5.0|8.0|||||Non inferiority criterion versus prednisone 10 mg: Lower bound of 60% credible interval \>-5%. Non-responder imputation was used to handle dropouts at Week 8.|Bayesian 4 Parameter Emax Model Based Estimates are provided.||8|-5|
72343581|NCT01393639|144210783|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.64|||||TWO_SIDED|95.0|-13.75|17.03|||||Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used.|||17.03|-13.75|
72343582|NCT01393639|144210783|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.71|||||TWO_SIDED|90.0|-22.16|8.75|||||Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used.|||8.75|-22.16|
72343583|NCT01393639|144210783|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.07|||||TWO_SIDED|90.0|-20.45|10.3|||||Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used.|||10.30|-20.45|
72343584|NCT01393639|144210783|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-11.74|||||TWO_SIDED|90.0|-27.19|3.72|||||Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used.|||3.72|-27.19|
72343585|NCT01393639|144210784|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.34|||||TWO_SIDED|95.0|-12.92|19.61|||||Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used.|||19.61|-12.92|
72343586|NCT01393639|144210784|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.52|||||TWO_SIDED|90.0|-22.86|9.81|||||Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used.|||9.81|-22.86|
72343587|NCT01393639|144210784|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.22|||||TWO_SIDED|90.0|-12.11|20.55|||||Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used.|||20.55|-12.11|
72343588|NCT01393639|144210784|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|12.83|||||TWO_SIDED|90.0|-3.49|29.15|||||Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used.|||29.15|-3.49|
72343589|NCT01393639|144210785|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|11.36|||||TWO_SIDED|95.0|-6.84|29.56|||||Non-responder imputation was used to handle dropouts.|Week 2 analysis presented in this section for comparison to placebo.||29.56|-6.84|
72343590|NCT01393639|144210785|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|12.15|||||TWO_SIDED|95.0|-5.88|30.19|||||Non-responder imputation was used to handle dropouts.|Week 2 analysis presented in this section for comparison to placebo.||30.19|-5.88|
72343591|NCT01393639|144210785|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|19.54|||||TWO_SIDED|95.0|0.91|38.17|||||Non-responder imputation was used to handle dropouts.|Week 2 analysis presented in this section for comparison to placebo.||38.17|0.91|
72343592|NCT01393639|144210785|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|22.09|||||TWO_SIDED|95.0|3.6|40.58|||||Non-responder imputation was used to handle dropouts.|Week 2 analysis presented in this section for comparison to placebo.||40.58|3.60|
72343593|NCT01393639|144210785|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|8.43|||||TWO_SIDED|95.0|-9.38|26.25|||||Non-responder imputation was used to handle dropouts.|Week 2 analysis presented in this section for comparison to placebo.||26.25|-9.38|
72343594|NCT01393639|144210785|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|16.5|||||TWO_SIDED|95.0|-1.84|34.84|||||Non-responder imputation was used to handle dropouts.|Week 2 analysis presented in this section for comparison to placebo.||34.84|-1.84|
72343595|NCT01393639|144210785|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|-8.88|||||TWO_SIDED|95.0|-28.58|10.8|||||Non-responder imputation was used to handle dropouts.|Week 4 analysis presented in this section for comparison to placebo.||10.80|-28.58|
72343596|NCT01393639|144210785|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|15.31|||||TWO_SIDED|95.0|-4.85|35.49|||||Non-responder imputation was used to handle dropouts.|Week 4 analysis presented in this section for comparison to placebo.||35.49|-4.85|
72343597|NCT01393639|144210785|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|26.66|||||TWO_SIDED|95.0|6.8|46.53|||||Non-responder imputation was used to handle dropouts.|Week 4 analysis presented in this section for comparison to placebo.||46.53|6.80|
72343598|NCT01393639|144210785|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|13.19|||||TWO_SIDED|95.0|-7.01|33.4|||||Non-responder imputation was used to handle dropouts.|Week 4 analysis presented in this section for comparison to placebo.||33.40|-7.01|
72343599|NCT01393639|144210785|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|8.88|||||TWO_SIDED|95.0|-11.56|29.33|||||Non-responder imputation was used to handle dropouts.|Week 4 analysis presented in this section for comparison to placebo.||29.33|-11.56|
72343600|NCT01393639|144210785|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|25.21|||||TWO_SIDED|95.0|5.35|45.07|||||Non-responder imputation was used to handle dropouts.|Week 4 comparisons presented in this section for comparison to placebo.||45.07|5.35|
72370119|NCT01485172|144250628|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.75||||0.15|TWO_SIDED|95.0|-6.5|1.01||P-values are from a Mixed Model Repeated Measures analysis.|Mixed Models Analysis|||||1.01|-6.50|0.150
72370120|NCT01485172|144250628|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.74||||0.048|TWO_SIDED|95.0|-7.43|-0.04||P-values are from a Mixed Model Repeated Measures analysis.|Mixed Models Analysis|||||-0.04|-7.43|0.048
72370121|NCT01485172|144250628|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.99||||0.715|TWO_SIDED|95.0|-6.32|4.35||P-values are from a Mixed Model Repeated Measures analysis.|Mixed Models Analysis|||||4.35|-6.32|0.715
72343601|NCT01393639|144210785|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|2.22|||||TWO_SIDED|95.0|-17.4|21.85|||||Non-responder imputation was used to handle dropouts.|Week 12 analysis presented in this section for comparison to placebo.||21.85|-17.40|
72343602|NCT01393639|144210785|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|15.6|||||TWO_SIDED|95.0|-4.24|35.45|||||Non-responder imputation was used to handle dropouts.|Week 12 analysis presented in this section for comparison to placebo.||35.45|-4.24|
72343603|NCT01393639|144210785|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|22.22|||||TWO_SIDED|95.0|2.2|42.23|||||Non-responder imputation was used to handle dropouts.|Week 12 analysis presented in this section for comparison to placebo.||42.23|2.20|
72343604|NCT01393639|144210785|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|4.96|||||TWO_SIDED|95.0|-14.6|24.53|||||Non-responder imputation was used to handle dropouts.|Week 12 analysis presented in this section for comparison to placebo.||24.53|-14.60|
72343605|NCT01393639|144210785|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|15.55|||||TWO_SIDED|95.0|-4.51|35.63|||||Non-responder imputation was used to handle dropouts.|Week 12 analysis presented in this section for comparison to placebo.||35.63|-4.51|
72343606|NCT01393639|144210785|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|23.18|||||TWO_SIDED|95.0|3.31|43.06|||||Non-responder imputation was used to handle dropouts.|Week 12 analysis presented in this section for comparison to placebo.||43.06|3.31|
72343607|NCT01393639|144210785|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|-5.13|||||TWO_SIDED|95.0|-24.73|14.45|||||Non-responder imputation was used to handle dropouts.|Week 2 analysis presented in this section for comparison to prednisone 10 mg.||14.45|-24.73|
72343608|NCT01393639|144210785|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|-4.34|||||TWO_SIDED|95.0|-23.79|15.09|||||Non-responder imputation was used to handle dropouts.|Week 2 analysis presented in this section for comparison to prednisone 10 mg.||15.09|-23.79|
72343609|NCT01393639|144210785|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|3.04|||||TWO_SIDED|95.0|-16.94|23.02|||||Non-responder imputation was used to handle dropouts.|Week 2 analysis presented in this section for comparison to prednisone 10 mg.||23.02|-16.94|
72343610|NCT01393639|144210785|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|5.59|||||TWO_SIDED|95.0|-14.26|25.45|||||Non-responder imputation was used to handle dropouts.|Week 2 analysis presented in this section for comparison to prednisone 10 mg.||25.45|-14.26|
72343611|NCT01393639|144210785|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|-34.1|||||TWO_SIDED|95.0|-53.4|-14.8|||||Non-responder imputation was used to handle dropouts.|Week 4 analysis presented in this section for comparison to prednisone 10 mg.||-14.80|-53.40|
72343612|NCT01393639|144210785|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|-9.89|||||TWO_SIDED|95.0|-29.68|9.88|||||Non-responder imputation was used to handle dropouts.|Week 4 analysis presented in this section for comparison to prednisone 10 mg.||9.88|-29.68|
72343613|NCT01393639|144210785|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|1.44|||||TWO_SIDED|95.0|-18.02|20.92|||||Non-responder imputation was used to handle dropouts.|Week 4 analysis presented in this section for comparison to prednisone 10 mg.||20.92|-18.02|
72343614|NCT01393639|144210785|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|-12.02|||||TWO_SIDED|95.0|-31.84|7.79|||||Non-responder imputation was used to handle dropouts.|Week 4 analysis presented in this section for comparison to prednisone 10 mg.||7.79|-31.84|
72343615|NCT01393639|144210785|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|-20.96|||||TWO_SIDED|95.0|-40.98|-0.94|||||Non-responder imputation was used to handle dropouts.|Week 12 analysis presented in this section for comparison to prednisone 10 mg.||-0.94|-40.98|
72343616|NCT01393639|144210785|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|-7.58|||||TWO_SIDED|95.0|-27.82|12.65|||||Non-responder imputation was used to handle dropouts.|Week 12 analysis presented in this section for comparison to prednisone 10 mg.||12.65|-27.82|
72343617|NCT01393639|144210785|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|-0.96|||||TWO_SIDED|95.0|-21.36|19.43|||||Non-responder imputation was used to handle dropouts.|Week 12 analysis presented in this section for comparison to prednisone 10 mg.||19.43|-21.36|
72343618|NCT01393639|144210785|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|-18.22|||||TWO_SIDED|95.0|-38.18|1.73|||||Non-responder imputation was used to handle dropouts.|Week 12 analysis presented in this section for comparison to prednisone 10 mg.||1.73|-38.18|
72343619|NCT01393639|144210786|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|-2.27|||||TWO_SIDED|95.0|-11.93|7.38|||||Non-responder imputation was used to handle dropouts.|Week 2 analysis presented in this section for comparison to placebo.||7.38|-11.93|
72343620|NCT01393639|144210786|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|1.87|||||TWO_SIDED|95.0|-9.15|12.91|||||Non-responder imputation was used to handle dropouts.|Week 2 analysis presented in this section for comparison to placebo.||12.91|-9.15|
72343621|NCT01393639|144210786|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|2.07|||||TWO_SIDED|95.0|-9.09|13.23|||||Non-responder imputation was used to handle dropouts.|Week 2 analysis presented in this section for comparison to placebo.||13.23|-9.09|
72343622|NCT01393639|144210786|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|18.71|||||TWO_SIDED|95.0|4.19|33.23|||||Non-responder imputation was used to handle dropouts.|Week 2 analysis presented in this section for comparison to placebo.||33.23|4.19|
72343623|NCT01393639|144210786|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|-4.59|||||TWO_SIDED|95.0|-13.19|4.0|||||Non-responder imputation was used to handle dropouts.|Week 2 analysis presented in this section for comparison to placebo.||4.00|-13.19|
72343624|NCT01393639|144210786|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|12.74|||||TWO_SIDED|95.0|-0.92|26.41|||||Non-responder imputation was used to handle dropouts.|Week 2 analysis presented in this section for comparison to placebo.||26.41|-0.92|
72343625|NCT01393639|144210786|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|-2.22|||||TWO_SIDED|95.0|-14.6|10.16|||||Non-responder imputation was used to handle dropouts.|Week 4 analysis presented in this section for comparison to placebo.||10.16|-14.60|
72343626|NCT01393639|144210786|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|12.29|||||TWO_SIDED|95.0|-2.9|27.48|||||Non-responder imputation was used to handle dropouts.|Week 4 analysis presented in this section for comparison to placebo.||27.48|-2.90|
72343627|NCT01393639|144210786|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|24.44|||||TWO_SIDED|95.0|7.71|41.17|||||Non-responder imputation was used to handle dropouts.|Week 4 analysis presented in this section for comparison to placebo.||41.17|7.71|
72343628|NCT01393639|144210786|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|16.54|||||TWO_SIDED|95.0|0.8|32.29|||||Non-responder imputation was used to handle dropouts.|Week 4 analysis presented in this section for comparison to placebo.||32.29|0.80|
72343629|NCT01393639|144210786|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|0.0|||||TWO_SIDED|95.0|-12.98|12.98|||||Non-responder imputation was used to handle dropouts.|Week 4 analysis presented in this section for comparison to placebo.||12.98|-12.98|
72343630|NCT01393639|144210786|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|19.32|||||TWO_SIDED|95.0|3.16|35.48|||||Non-responder imputation was used to handle dropouts.|Week 4 analysis presented in this section for comparison to placebo.||35.48|3.16|
72343631|NCT01393639|144210786|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|-4.44|||||TWO_SIDED|95.0|-18.46|9.57|||||Non-responder imputation was used to handle dropouts.|Week 6 analysis presented in this section for comparison to placebo.||9.57|-18.46|
72343632|NCT01393639|144210786|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|12.1|||||TWO_SIDED|95.0|-4.49|28.7|||||Non-responder imputation was used to handle dropouts.|Week 6 analysis presented in this section for comparison to placebo.||28.70|-4.49|
72343633|NCT01393639|144210786|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|24.44|||||TWO_SIDED|95.0|6.63|42.24|||||Non-responder imputation was used to handle dropouts.|Week 6 analysis presented in this section for comparison to placebo.||42.24|6.63|
72343634|NCT01393639|144210786|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|26.99|||||TWO_SIDED|95.0|9.33|44.65|||||Non-responder imputation was used to handle dropouts.|Week 6 analysis presented in this section for comparison to placebo.||44.65|9.33|
72343635|NCT01393639|144210786|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|8.88|||||TWO_SIDED|95.0|-7.53|25.31|||||Non-responder imputation was used to handle dropouts.|Week 6 analysis presented in this section for comparison to placebo.||25.31|-7.53|
72343636|NCT01393639|144210786|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|21.4|||||TWO_SIDED|95.0|3.88|38.91|||||Non-responder imputation was used to handle dropouts.|Week 6 analysis presented in this section for comparison to placebo.||38.91|3.88|
72343637|NCT01393639|144210786|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|8.88|||||TWO_SIDED|95.0|-6.8|24.57|||||Non-responder imputation was used to handle dropouts.|Week 8 analysis presented in this section for comparison to placebo.||24.57|-6.80|
72343638|NCT01393639|144210786|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|18.58|||||TWO_SIDED|95.0|1.96|35.2|||||Non-responder imputation was used to handle dropouts.|Week 8 analysis presented in this section for comparison to placebo.||35.20|1.96|
72343639|NCT01393639|144210786|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|35.55|||||TWO_SIDED|95.0|17.89|53.21|||||Non-responder imputation was used to handle dropouts.|Week 8 analysis presented in this section for comparison to placebo.||53.21|17.89|
72343640|NCT01393639|144210786|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|29.21|||||TWO_SIDED|95.0|11.94|46.49|||||Non-responder imputation was used to handle dropouts.|Week 8 analysis presented in this section for comparison to placebo.||46.49|11.94|
72343641|NCT01393639|144210786|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|13.33|||||TWO_SIDED|95.0|-2.96|29.63|||||Non-responder imputation was used to handle dropouts.|Week 8 analysis presented in this section for comparison to placebo.||29.63|-2.96|
72343642|NCT01393639|144210786|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|32.31|||||TWO_SIDED|95.0|14.83|49.8|||||Non-responder imputation was used to handle dropouts.|Week 8 analysis presented in this section for comparison to placebo.||49.80|14.83|
72343643|NCT01393639|144210786|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|0.0|||||TWO_SIDED|95.0|-15.79|15.79|||||Non-responder imputation was used to handle dropouts.|Week 12 analysis presented in this section for comparison to placebo.||15.79|-15.79|
72343644|NCT01393639|144210786|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|3.49|||||TWO_SIDED|95.0|-12.67|19.67|||||Non-responder imputation was used to handle dropouts.|Week 12 analysis presented in this section for comparison to placebo.||19.67|-12.67|
72343645|NCT01393639|144210786|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|6.66|||||TWO_SIDED|95.0|-10.13|23.47|||||Non-responder imputation was used to handle dropouts.|Week 12 analysis presented in this section for comparison to placebo.||23.47|-10.13|
72343646|NCT01393639|144210786|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|-0.75|||||TWO_SIDED|95.0|-16.25|14.74|||||Non-responder imputation was used to handle dropouts.|Week 12 analysis presented in this section for comparison to placebo.||14.74|-16.25|
72343647|NCT01393639|144210786|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|8.88|||||TWO_SIDED|95.0|-8.19|25.96|||||Non-responder imputation was used to handle dropouts.|Week 12 analysis presented in this section for comparison to placebo.||25.96|-8.19|
72343648|NCT01393639|144210786|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|6.13|||||TWO_SIDED|95.0|-10.5|22.77|||||Non-responder imputation was used to handle dropouts.|Week 12 analysis presented in this section for comparison to placebo.||22.77|-10.50|
72343649|NCT01393639|144210786|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|-15.01|||||TWO_SIDED|95.0|-28.03|-2.0|||||Non-responder imputation was used to handle dropouts.|Week 2 analysis presented in this section for comparison to prednisone 10 mg.||-2.00|-28.03|
72343650|NCT01393639|144210786|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|-10.86|||||TWO_SIDED|95.0|-24.93|3.19|||||Non-responder imputation was used to handle dropouts.|Week 2 analysis presented in this section for comparison to prednisone 10 mg.||3.19|-24.93|
72343651|NCT01393639|144210786|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|-10.67|||||TWO_SIDED|95.0|-24.83|3.48|||||Non-responder imputation was used to handle dropouts.|Week 2 analysis presented in this section for comparison to prednisone 10 mg.||3.48|-24.83|
72343652|NCT01393639|144210786|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|5.96|||||TWO_SIDED|95.0|-10.96|22.9|||||Non-responder imputation was used to handle dropouts.|Week 2 analysis presented in this section for comparison to prednisone 10 mg.||22.90|-10.96|
72343653|NCT01393639|144210786|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|-21.54|||||TWO_SIDED|95.0|-37.22|-5.86|||||Non-responder imputation was used to handle dropouts.|Week 4 analysis presented in this section for comparison to prednisone 10 mg.||-5.86|-37.22|
72343654|NCT01393639|144210786|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|-7.03|||||TWO_SIDED|95.0|-25.01|10.95|||||Non-responder imputation was used to handle dropouts.|Week 4 analysis presented in this section for comparison to prednisone 10 mg.||10.95|-25.01|
72343655|NCT01393639|144210786|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|5.12|||||TWO_SIDED|95.0|-14.17|24.41|||||Non-responder imputation was used to handle dropouts.|Week 4 analysis presented in this section for comparison to prednisone 10 mg.||24.41|-14.17|
72343656|NCT01393639|144210786|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|-2.77|||||TWO_SIDED|95.0|-21.22|15.67|||||Non-responder imputation was used to handle dropouts.|Week 4 analysis presented in this section for comparison to prednisone 10 mg.||15.67|-21.22|
72343657|NCT01393639|144210786|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|-25.84|||||TWO_SIDED|95.0|-42.54|-9.14|||||Non-responder imputation was used to handle dropouts.|Week 6 analysis presented in this section for comparison to prednisone 10 mg.||-9.14|-42.54|
72343658|NCT01393639|144210786|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|-9.29|||||TWO_SIDED|95.0|-28.22|9.62|||||Non-responder imputation was used to handle dropouts.|Week 6 analysis presented in this section for comparison to prednisone 10 mg.||9.62|-28.22|
72343659|NCT01393639|144210786|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|3.04|||||TWO_SIDED|95.0|-16.94|23.02|||||Non-responder imputation was used to handle dropouts.|Week 6 analysis presented in this section for comparison to prednisone 10 mg.||23.02|-16.94|
72343660|NCT01393639|144210786|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|5.59|||||TWO_SIDED|95.0|-14.26|25.45|||||Non-responder imputation was used to handle dropouts.|Week 6 analysis presented in this section for comparison to prednisone 10 mg.||25.45|-14.26|
72343661|NCT01393639|144210786|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|-23.42|||||TWO_SIDED|95.0|-42.26|-4.59|||||Non-responder imputation was used to handle dropouts.|Week 8 analysis presented in this section for comparison to prednisone 10 mg.||-4.59|-42.26|
72343662|NCT01393639|144210786|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|-13.73|||||TWO_SIDED|95.0|-33.35|5.87|||||Non-responder imputation was used to handle dropouts.|Week 8 analysis presented in this section for comparison to prednisone 10 mg.||5.87|-33.35|
72343663|NCT01393639|144210786|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|3.23|||||TWO_SIDED|95.0|-17.26|23.74|||||Non-responder imputation was used to handle dropouts.|Week 8 analysis presented in this section for comparison to prednisone 10 mg.||23.74|-17.26|
72343664|NCT01393639|144210786|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|-3.09|||||TWO_SIDED|95.0|-23.27|17.07|||||Non-responder imputation was used to handle dropouts.|Week 8 analysis presented in this section for comparison to prednisone 10 mg.||17.07|-23.27|
72343665|NCT01393639|144210786|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|-6.13|||||TWO_SIDED|95.0|-22.77|10.5|||||Non-responder imputation was used to handle dropouts.|Week 12 analysis presented in this section for comparison to prednisone 10 mg.||10.50|-22.77|
72343666|NCT01393639|144210786|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|-2.63|||||TWO_SIDED|95.0|-19.63|14.35|||||Non-responder imputation was used to handle dropouts.|Week 12 analysis presented in this section for comparison to prednisone 10 mg.||14.35|-19.63|
72343667|NCT01393639|144210786|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|0.53|||||TWO_SIDED|95.0|-17.06|18.12|||||Non-responder imputation was used to handle dropouts.|Week 12 analysis presented in this section for comparison to prednisone 10 mg.||18.12|-17.06|
72343668|NCT01393639|144210786|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|-6.89|||||TWO_SIDED|95.0|-23.24|9.46|||||Non-responder imputation was used to handle dropouts.|Week 12 analysis presented in this section for comparison to prednisone 10 mg.||9.46|-23.24|
72343669|NCT01393639|144210787|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|0.0|||||TWO_SIDED|95.0|0.0|0.0|||||Non-responder imputation was used to handle dropouts.|Week 2 analysis presented in this section for comparison to placebo.||0.00|0.00|
72343670|NCT01393639|144210787|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|4.34|||||TWO_SIDED|95.0|-1.54|10.24|||||Non-responder imputation was used to handle dropouts.|Week 2 analysis presented in this section for comparison to placebo.||10.24|-1.54|
72343671|NCT01393639|144210787|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|2.22|||||TWO_SIDED|95.0|-2.08|6.52|||||Non-responder imputation was used to handle dropouts.|Week 2 analysis presented in this section for comparison to placebo.||6.52|-2.08|
72343672|NCT01393639|144210787|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|6.38|||||TWO_SIDED|95.0|-0.6|13.37|||||Non-responder imputation was used to handle dropouts.|Week 2 analysis presented in this section for comparison to placebo.||13.37|-0.60|
72343673|NCT01393639|144210787|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|2.22|||||TWO_SIDED|95.0|-2.08|6.52|||||Non-responder imputation was used to handle dropouts.|Week 2 analysis presented in this section for comparison to placebo.||6.52|-2.08|
72343674|NCT01393639|144210787|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|8.69|||||TWO_SIDED|95.0|0.55|16.83|||||Non-responder imputation was used to handle dropouts.|Week 2 analysis presented in this section for comparison to placebo.||16.83|0.55|
72343675|NCT01393639|144210787|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|0.0|||||TWO_SIDED|95.0|0.0|0.0|||||Non-responder imputation was used to handle dropouts.|Week 4 analysis presented in this section for comparison to placebo.||0.00|0.00|
72343676|NCT01393639|144210787|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|8.51|||||TWO_SIDED|95.0|0.53|16.48|||||Non-responder imputation was used to handle dropouts.|Week 4 analysis presented in this section for comparison to placebo.||16.48|0.53|
72343677|NCT01393639|144210787|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|15.55|||||TWO_SIDED|95.0|4.96|26.14|||||Non-responder imputation was used to handle dropouts.|Week 4 analysis presented in this section for comparison to placebo.||26.14|4.96|
72343678|NCT01393639|144210787|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|17.02|||||TWO_SIDED|95.0|6.27|27.76|||||Non-responder imputation was used to handle dropouts.|Week 4 analysis presented in this section for comparison to placebo.||27.76|6.27|
72343679|NCT01393639|144210787|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|4.44|||||TWO_SIDED|95.0|-1.57|10.46|||||Non-responder imputation was used to handle dropouts.|Week 4 analysis presented in this section for comparison to placebo.||10.46|-1.57|
72343680|NCT01393639|144210787|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|15.21|||||TWO_SIDED|95.0|4.83|25.59|||||Non-responder imputation was used to handle dropouts.|Week 4 analysis presented in this section for comparison to placebo.||25.59|4.83|
72343681|NCT01393639|144210787|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|-2.22|||||TWO_SIDED|95.0|-9.62|5.18|||||Non-responder imputation was used to handle dropouts.|Week 6 analysis presented in this section for comparison to placebo.||5.18|-9.62|
72343682|NCT01393639|144210787|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|8.32|||||TWO_SIDED|95.0|-2.96|19.6|||||Non-responder imputation was used to handle dropouts.|Week 6 analysis presented in this section for comparison to placebo.||19.60|-2.96|
72343683|NCT01393639|144210787|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|8.88|||||TWO_SIDED|95.0|-2.72|20.5|||||Non-responder imputation was used to handle dropouts.|Week 6 analysis presented in this section for comparison to placebo.||20.50|-2.72|
72343684|NCT01393639|144210787|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|12.57|||||TWO_SIDED|95.0|0.26|24.89|||||Non-responder imputation was used to handle dropouts.|Week 6 analysis presented in this section for comparison to placebo.||24.89|0.26|
72343685|NCT01393639|144210787|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|2.22|||||TWO_SIDED|95.0|-7.23|11.67|||||Non-responder imputation was used to handle dropouts.|Week 6 analysis presented in this section for comparison to placebo.||11.67|-7.23|
72343686|NCT01393639|144210787|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|17.29|||||TWO_SIDED|95.0|3.94|30.64|||||Non-responder imputation was used to handle dropouts.|Week 6 analysis presented in this section for comparison to placebo.||30.64|3.94|
72343687|NCT01393639|144210787|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|-2.22|||||TWO_SIDED|95.0|-14.6|10.16|||||Non-responder imputation was used to handle dropouts.|Week 8 analysis presented in this section for comparison to placebo.||10.16|-14.60|
72343688|NCT01393639|144210787|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|5.91|||||TWO_SIDED|95.0|-8.22|20.04|||||Non-responder imputation was used to handle dropouts.|Week 8 analysis presented in this section for comparison to placebo.||20.04|-8.22|
72343689|NCT01393639|144210787|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|15.55|||||TWO_SIDED|95.0|-0.29|31.4|||||Non-responder imputation was used to handle dropouts.|Week 8 analysis presented in this section for comparison to placebo.||31.40|-0.29|
72343690|NCT01393639|144210787|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|10.16|||||TWO_SIDED|95.0|-4.7|25.03|||||Non-responder imputation was used to handle dropouts.|Week 8 analysis presented in this section for comparison to placebo.||25.03|-4.70|
72428664|NCT01755689|144368338|NON_INFERIORITY|For HPV-18, one month after the third dose of Cervarix, the UL of the two-sided standardized asymptotic 95% CI on the group GMT ratio had to be below the pre-defined limit of 2.|Adjusted GMT|1.09|||||TWO_SIDED|95.0|0.92|1.29|||ANCOVA|||Adjusted GMT ratio of the Cervarix Group versus Nimenrix+Cervarix (0,1,6-Month) Group in terms of HPV-18 titers.||1.29|0.92|
72428665|NCT01755689|144368338|NON_INFERIORITY|For HPV-16, one month after the third dose of Cervarix, the UL of the two-sided standardized asymptotic 95% CI on the group GMT ratio had to be below the pre-defined limit of 2.|Adjusted GMT|1.2|||||TWO_SIDED|95.0|1.01|1.43|||ANCOVA|||Adjusted GMT ratio of the Boostrix+Cervarix Group versus Nimenrix+Cervarix+Boostrix Group in terms of HPV-16 titers.||1.43|1.01|
72428666|NCT01755689|144368338|NON_INFERIORITY|For HPV-18, one month after the third dose of Cervarix, the UL of the two-sided standardized asymptotic 95% CI on the group GMT ratio had to be below the pre-defined limit of 2.|Adjusted GMT|1.19|||||TWO_SIDED|95.0|1.0|1.41|||ANCOVA|||Adjusted GMT ratio of the Boostrix+Cervarix Group versus Nimenrix+Cervarix+Boostrix Group in terms of HPV-18 titers.||1.41|1.00|
72428667|NCT01755689|144368339|NON_INFERIORITY|For anti-D the lower limit (LL) of the 2-sided standardised asymptotic 95% CI for the group difference (Nimenrix+Cervarix+Boostrix Group minus Boostrix +Cervarix Group) had to be greater than or equal to the pre-defined limit of -10%.|Difference between groups|-2.88|||||TWO_SIDED|95.0|-6.9|0.81||||||The group difference of the Nimenrix+Cervarix+Boostrix Group and Boostrix+Cervarix Group in terms of Anti-D titers.||0.81|-6.90|
72343691|NCT01393639|144210787|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|-4.44|||||TWO_SIDED|95.0|-16.16|7.27|||||Non-responder imputation was used to handle dropouts.|Week 8 analysis presented in this section for comparison to placebo.||7.27|-16.16|
72343692|NCT01393639|144210787|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|14.97|||||TWO_SIDED|95.0|-0.68|30.63|||||Non-responder imputation was used to handle dropouts.|Week 8 analysis presented in this section for comparison to placebo.||30.63|-0.68|
72343693|NCT01393639|144210787|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|0.0|||||TWO_SIDED|95.0|-10.3|10.3|||||Non-responder imputation was used to handle dropouts.|Week 12 analysis presented in this section for comparison to placebo.||10.30|-10.30|
72343694|NCT01393639|144210787|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|6.09|||||TWO_SIDED|95.0|-5.9|18.1|||||Non-responder imputation was used to handle dropouts.|Week 12 analysis presented in this section for comparison to placebo.||18.10|-5.90|
72343695|NCT01393639|144210787|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|0.0|||||TWO_SIDED|95.0|-10.3|10.3|||||Non-responder imputation was used to handle dropouts.|Week 12 analysis presented in this section for comparison to placebo.||10.30|-10.30|
72343696|NCT01393639|144210787|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|1.84|||||TWO_SIDED|95.0|-8.96|12.64|||||Non-responder imputation was used to handle dropouts.|Week 12 analysis presented in this section for comparison to placebo.||12.64|-8.96|
72343697|NCT01393639|144210787|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|4.44|||||TWO_SIDED|95.0|-7.27|16.16|||||Non-responder imputation was used to handle dropouts.|Week 12 analysis presented in this section for comparison to placebo.||16.16|-7.27|
72343698|NCT01393639|144210787|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|4.2|||||TWO_SIDED|95.0|-7.37|15.77|||||Non-responder imputation was used to handle dropouts.|Week 12 analysis presented in this section for comparison to placebo.||15.77|-7.37|
72343699|NCT01393639|144210787|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|-8.69|||||TWO_SIDED|95.0|-16.83|-0.55|||||Non-responder imputation was used to handle dropouts.|Week 2 analysis presented in this section for comparison to prednisone 10 mg.||-0.55|-16.83|
72343700|NCT01393639|144210787|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|-4.34|||||TWO_SIDED|95.0|-14.39|5.7|||||Non-responder imputation was used to handle dropouts.|Week 2 analysis presented in this section for comparison to prednisone 10 mg.||5.70|-14.39|
72343701|NCT01393639|144210787|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|-6.47|||||TWO_SIDED|95.0|-15.68|2.73|||||Non-responder imputation was used to handle dropouts.|Week 2 analysis presented in this section for comparison to prednisone 10 mg.||2.73|-15.68|
72343702|NCT01393639|144210787|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|-2.31|||||TWO_SIDED|95.0|-13.04|8.41|||||Non-responder imputation was used to handle dropouts.|Week 2 analysis presented in this section for comparison to prednisone 10 mg.||8.41|-13.04|
72343703|NCT01393639|144210787|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|-15.21|||||TWO_SIDED|95.0|-25.59|-4.83|||||Non-responder imputation was used to handle dropouts.|Week 4 analysis presented in this section for comparison to prednisone 10 mg.||-4.83|-25.59|
72343704|NCT01393639|144210787|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|-6.7|||||TWO_SIDED|95.0|-19.79|6.38|||||Non-responder imputation was used to handle dropouts.|Week 4 analysis presented in this section for comparison to prednisone 10 mg.||6.38|-19.79|
72343705|NCT01393639|144210787|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|0.33|||||TWO_SIDED|95.0|-14.49|15.16|||||Non-responder imputation was used to handle dropouts.|Week 4 analysis presented in this section for comparison to prednisone 10 mg.||15.16|-14.49|
72343706|NCT01393639|144210787|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|1.8|||||TWO_SIDED|95.0|-13.13|16.74|||||Non-responder imputation was used to handle dropouts.|Week 4 analysis presented in this section for comparison to prednisone 10 mg.||16.74|-13.13|
72343707|NCT01393639|144210787|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|-19.51|||||TWO_SIDED|95.0|-32.19|-6.84|||||Non-responder imputation was used to handle dropouts.|Week 6 analysis presented in this section for comparison to prednisone 10 mg.||-6.84|-32.19|
72343708|NCT01393639|144210787|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|-8.97|||||TWO_SIDED|95.0|-24.24|6.29|||||Non-responder imputation was used to handle dropouts.|Week 6 analysis presented in this section for comparison to prednisone 10 mg.||6.29|-24.24|
72343709|NCT01393639|144210787|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|-8.4|||||TWO_SIDED|95.0|-23.92|7.1|||||Non-responder imputation was used to handle dropouts.|Week 6 analysis presented in this section for comparison to prednisone 10 mg.||7.10|-23.92|
72343710|NCT01393639|144210787|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|-4.71|||||TWO_SIDED|95.0|-20.76|11.32|||||Non-responder imputation was used to handle dropouts.|Week 6 analysis presented in this section for comparison to prednisone 10 mg.||11.32|-20.76|
72343711|NCT01393639|144210787|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|-17.19|||||TWO_SIDED|95.0|-32.36|-2.02|||||Non-responder imputation was used to handle dropouts.|Week 8 analysis presented in this section for comparison to prednisone 10 mg.||-2.02|-32.36|
72343712|NCT01393639|144210787|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|-9.06|||||TWO_SIDED|95.0|-25.69|7.56|||||Non-responder imputation was used to handle dropouts.|Week 8 analysis presented in this section for comparison to prednisone 10 mg.||7.56|-25.69|
72343713|NCT01393639|144210787|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|0.57|||||TWO_SIDED|95.0|-17.53|18.68|||||Non-responder imputation was used to handle dropouts.|Week 8 analysis presented in this section for comparison to prednisone 10 mg.||18.68|-17.53|
72428668|NCT01755689|144368339|NON_INFERIORITY|For anti-T the LL of the 2-sided standardised asymptotic 95% CI for the group difference (Nimenrix+Cervarix+Boostrix Group minus Boostrix +Cervarix Group) had to be greater than or equal to the pre-defined limit of -10%.|Difference between groups|-0.4|||||TWO_SIDED|95.0|-2.23|1.08||||||The group difference of the Nimenrix+Cervarix+Boostrix Group and Boostrix+Cervarix Group in terms of Anti-T titers.||1.08|-2.23|
72428669|NCT01755689|144368340|NON_INFERIORITY|For anti-PRN the UL of the 2-sided standardised asymptotic 95% CI for the adjusted group ratio of GMCs (Nimenrix+Cervarix+Boostrix Group/Boostrix+Cervarix Group) had to be less than or equal to the pre-defined limit of 1.5.|Adjusted GMT Ratio|1.53|||||TWO_SIDED|95.0|1.25|1.87|||ANCOVA|||Adjusted GMT ratio of the Nimenrix+Cervarix+Boostrix Group versus Boostrix+ Cervarix Group in terms of anti-PRN titers.||1.87|1.25|
72343714|NCT01393639|144210787|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|-4.81|||||TWO_SIDED|95.0|-22.07|12.45|||||Non-responder imputation was used to handle dropouts.|Week 8 analysis presented in this section for comparison to prednisone 10 mg.||12.45|-22.07|
72343715|NCT01393639|144210787|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|-4.2|||||TWO_SIDED|95.0|-15.77|7.37|||||Non-responder imputation was used to handle dropouts.|Week 12 analysis presented in this section for comparison to prednisone 10 mg.||7.37|-15.77|
72343716|NCT01393639|144210787|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|1.89|||||TWO_SIDED|95.0|-11.21|15.0|||||Non-responder imputation was used to handle dropouts.|Week 12 analysis presented in this section for comparison to prednisone 10 mg.||15.00|-11.21|
72343717|NCT01393639|144210787|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|-4.2|||||TWO_SIDED|95.0|-15.77|7.37|||||Non-responder imputation was used to handle dropouts.|Week 12 analysis presented in this section for comparison to prednisone 10 mg.||7.37|-15.77|
72343718|NCT01393639|144210787|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|-2.35|||||TWO_SIDED|95.0|-14.38|9.66|||||Non-responder imputation was used to handle dropouts.|Week 12 analysis presented in this section for comparison to prednisone 10 mg.||9.66|-14.38|
72343719|NCT01393639|144210788|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.13|||||TWO_SIDED|95.0|-4.19|-0.07||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.07|-4.19|
72343720|NCT01393639|144210788|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.6|||||TWO_SIDED|95.0|-5.63|-1.57||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-1.57|-5.63|
72343721|NCT01393639|144210788|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.02|||||TWO_SIDED|95.0|-5.06|-0.97||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.97|-5.06|
72343722|NCT01393639|144210788|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.7|||||TWO_SIDED|95.0|-5.73|-1.68||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-1.68|-5.73|
72343723|NCT01393639|144210788|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.93|||||TWO_SIDED|95.0|-3.97|0.12||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.12|-3.97|
72343724|NCT01393639|144210788|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.43|||||TWO_SIDED|95.0|-5.46|-1.39||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-1.39|-5.46|
72343725|NCT01393639|144210788|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.81|||||TWO_SIDED|95.0|-4.03|0.42||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.42|-4.03|
72343726|NCT01393639|144210788|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.83|||||TWO_SIDED|95.0|-5.04|-0.62||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.62|-5.04|
72343727|NCT01393639|144210788|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.85|||||TWO_SIDED|95.0|-5.07|-0.64||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.64|-5.07|
72343728|NCT01393639|144210788|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.77|||||TWO_SIDED|95.0|-4.98|-0.56||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.56|-4.98|
72343729|NCT01393639|144210788|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.63|||||TWO_SIDED|95.0|-3.85|0.59||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.59|-3.85|
72343730|NCT01393639|144210788|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.27|||||TWO_SIDED|95.0|-5.48|-1.06||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-1.06|-5.48|
72343731|NCT01393639|144210788|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.23|||||TWO_SIDED|95.0|-4.66|0.2||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.20|-4.66|
72343732|NCT01393639|144210788|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.19|||||TWO_SIDED|95.0|-6.62|-1.77||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-1.77|-6.62|
72343733|NCT01393639|144210788|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.73|||||TWO_SIDED|95.0|-6.15|-1.31||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-1.31|-6.15|
72343734|NCT01393639|144210788|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.68|||||TWO_SIDED|95.0|-6.09|-1.26||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-1.26|-6.09|
72343735|NCT01393639|144210788|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.27|||||TWO_SIDED|95.0|-4.69|0.16||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.16|-4.69|
72343736|NCT01393639|144210788|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.11|||||TWO_SIDED|95.0|-6.52|-1.7||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-1.70|-6.52|
72343737|NCT01393639|144210788|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.8|||||TWO_SIDED|95.0|-5.34|-0.25||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.25|-5.34|
72343738|NCT01393639|144210788|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.38|||||TWO_SIDED|95.0|-6.93|-1.83||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-1.83|-6.93|
72343739|NCT01393639|144210788|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.2|||||TWO_SIDED|95.0|-7.74|-2.66||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-2.66|-7.74|
72370122|NCT01485172|144250629|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.17||||0.158|TWO_SIDED|95.0|-0.46|2.81||P-values are from a Mixed Model Repeated Measures analysis.|Mixed Models Analysis|||||2.81|-0.46|0.158
72370123|NCT01485172|144250629|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.47||||0.446|TWO_SIDED|95.0|-1.71|0.76||P-values are from a Mixed Model Repeated Measures analysis.|Mixed Models Analysis|||||0.76|-1.71|0.446
72370124|NCT01485172|144250629|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.87||||0.163|TWO_SIDED|95.0|-2.1|0.36||P-values are from a Mixed Model Repeated Measures analysis.|Mixed Models Analysis|||||0.36|-2.10|0.163
72370125|NCT01485172|144250629|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.01||||0.117|TWO_SIDED|95.0|-2.27|0.25||P-values are from a Mixed Model Repeated Measures analysis.|Mixed Models Analysis|||||0.25|-2.27|0.117
72370126|NCT01485172|144250629|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.73||||0.456|TWO_SIDED|95.0|-2.67|1.2||P-values are from a Mixed Model Repeated Measures analysis.|Mixed Models Analysis|||||1.20|-2.67|0.456
72370127|NCT01485172|144250630|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.56||||0.823|TWO_SIDED|95.0|-4.38|5.5||P-values are from a Mixed Model Repeated Measures analysis.|Mixed Models Analysis|||||5.50|-4.38|0.823
72370128|NCT01485172|144250630|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.09||||0.568|TWO_SIDED|95.0|-4.86|2.68||P-values are from a Mixed Model Repeated Measures analysis.|Mixed Models Analysis|||||2.68|-4.86|0.568
72370129|NCT01485172|144250630|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.19||||0.101|TWO_SIDED|95.0|-7.01|0.63||P-values are from a Mixed Model Repeated Measures analysis.|Mixed Models Analysis|||||0.63|-7.01|0.101
72343740|NCT01393639|144210788|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.9|||||TWO_SIDED|95.0|-7.43|-2.36||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-2.36|-7.43|
72343741|NCT01393639|144210788|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.74|||||TWO_SIDED|95.0|-5.28|-0.2||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.20|-5.28|
72343742|NCT01393639|144210788|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.57|||||TWO_SIDED|95.0|-7.1|-2.05||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-2.05|-7.10|
72343743|NCT01393639|144210788|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.3|||||TWO_SIDED|95.0|-0.73|3.33||||||Week 2 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||3.33|-0.73|
72343744|NCT01393639|144210788|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.17|||||TWO_SIDED|95.0|-2.18|1.84||||||Week 2 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||1.84|-2.18|
72343745|NCT01393639|144210788|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.41|||||TWO_SIDED|95.0|-1.61|2.44||||||Week 2 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||2.44|-1.61|
72343746|NCT01393639|144210788|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.27|||||TWO_SIDED|95.0|-2.27|1.73||||||Week 2 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||1.73|-2.27|
72343747|NCT01393639|144210788|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.47|||||TWO_SIDED|95.0|-0.74|3.68||||||Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||3.68|-0.74|
72343748|NCT01393639|144210788|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.45|||||TWO_SIDED|95.0|-1.76|2.65||||||Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||2.65|-1.76|
72343749|NCT01393639|144210788|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.42|||||TWO_SIDED|95.0|-1.79|2.63||||||Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||2.63|-1.79|
72343750|NCT01393639|144210788|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.51|||||TWO_SIDED|95.0|-1.69|2.7||||||Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||2.70|-1.69|
72343751|NCT01393639|144210788|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.88|||||TWO_SIDED|95.0|-0.53|4.29||||||Week 6 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||4.29|-0.53|
72343752|NCT01393639|144210788|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.08|||||TWO_SIDED|95.0|-2.5|2.33||||||Week 6 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||2.33|-2.50|
72343753|NCT01393639|144210788|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.38|||||TWO_SIDED|95.0|-2.03|2.79||||||Week 6 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||2.79|-2.03|
72343754|NCT01393639|144210788|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.43|||||TWO_SIDED|95.0|-1.97|2.84||||||Week 6 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||2.84|-1.97|
72343755|NCT01393639|144210788|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.78|||||TWO_SIDED|95.0|-0.75|4.3||||||Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||4.30|-0.75|
72343756|NCT01393639|144210788|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.19|||||TWO_SIDED|95.0|-2.34|2.73||||||Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||2.73|-2.34|
72370130|NCT01485172|144250630|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.94||||0.04|TWO_SIDED|95.0|-7.7|-0.18||P-values are from a Mixed Model Repeated Measures analysis.|Mixed Models Analysis|||||-0.18|-7.70|0.040
72370131|NCT01485172|144250630|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.66||||0.811|TWO_SIDED|95.0|-6.08|4.77||P-values are from a Mixed Model Repeated Measures analysis.|Mixed Models Analysis|||||4.77|-6.08|0.811
72343757|NCT01393639|144210788|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.62|||||TWO_SIDED|95.0|-3.14|1.89||||||Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||1.89|-3.14|
72343758|NCT01393639|144210788|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.33|||||TWO_SIDED|95.0|-2.84|2.19||||||Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||2.19|-2.84|
72343759|NCT01393639|144210790|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.18|||||TWO_SIDED|95.0|-2.91|0.56||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.56|-2.91|
72343760|NCT01393639|144210790|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.45|||||TWO_SIDED|95.0|-4.17|-0.73||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.73|-4.17|
72343761|NCT01393639|144210790|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.03|||||TWO_SIDED|95.0|-3.76|-0.29||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.29|-3.76|
72343762|NCT01393639|144210790|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.11|||||TWO_SIDED|95.0|-4.82|-1.4||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-1.40|-4.82|
72343763|NCT01393639|144210790|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.4|||||TWO_SIDED|95.0|-3.13|0.33||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.33|-3.13|
72343764|NCT01393639|144210790|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.8|||||TWO_SIDED|95.0|-4.52|-1.07||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-1.07|-4.52|
72428670|NCT01755689|144368340|NON_INFERIORITY|For anti-FHA the UL of the 2-sided standardised asymptotic 95% CI for the adjusted group ratio of GMCs (Nimenrix+Cervarix+Boostrix Group/Boostrix+Cervarix Group) had to be less than or equal to the pre-defined limit of 1.5.|Adjusted GMT Ratio|1.65|||||TWO_SIDED|95.0|1.42|1.93|||ANCOVA|||Adjusted GMT ratio of the Nimenrix+Cervarix Group versus Boostrix+ Cervarix Group in terms of anti-FHA titers.||1.93|1.42|
72343765|NCT01393639|144210790|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.67|||||TWO_SIDED|95.0|-3.63|0.29||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.29|-3.63|
72428671|NCT01755689|144368340|NON_INFERIORITY|For anti-PT the UL of the 2-sided standardised asymptotic 95% CI for the adjusted group ratio of GMCs (Nimenrix+Cervarix+Boostrix Group/Boostrix+Cervarix Group) had to be less than or equal to the pre-defined limit of 1.5.|Adjusted GMT Ratio|1.39|||||TWO_SIDED|95.0|1.2|1.61|||ANCOVA|||Adjusted GMT ratio of the Nimenrix+Cervarix Group versus Boostrix+ Cervarix Group in terms of anti-PT titers.||1.61|1.20|
72343766|NCT01393639|144210790|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.98|||||TWO_SIDED|95.0|-3.94|-0.01||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.01|-3.94|
72343767|NCT01393639|144210790|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.07|||||TWO_SIDED|95.0|-4.03|-0.11||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.11|-4.03|
72343768|NCT01393639|144210790|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.13|||||TWO_SIDED|95.0|-5.09|-1.17||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-1.17|-5.09|
72343769|NCT01393639|144210790|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.88|||||TWO_SIDED|95.0|-3.85|0.09||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.09|-3.85|
72343770|NCT01393639|144210790|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.84|||||TWO_SIDED|95.0|-4.79|-0.88||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.88|-4.79|
72343771|NCT01393639|144210790|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.32|||||TWO_SIDED|95.0|-3.25|0.6||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.60|-3.25|
72343772|NCT01393639|144210790|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.97|||||TWO_SIDED|95.0|-3.9|-0.04||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.04|-3.90|
72343773|NCT01393639|144210790|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.43|||||TWO_SIDED|95.0|-4.35|-0.5||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.50|-4.35|
72343774|NCT01393639|144210790|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.75|||||TWO_SIDED|95.0|-4.66|-0.83||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.83|-4.66|
72343775|NCT01393639|144210790|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.96|||||TWO_SIDED|95.0|-3.88|-0.03||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.03|-3.88|
72343776|NCT01393639|144210790|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.08|||||TWO_SIDED|95.0|-5.0|-1.17||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-1.17|-5.00|
72343777|NCT01393639|144210790|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.99|||||TWO_SIDED|95.0|-4.2|0.21||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.21|-4.20|
72343778|NCT01393639|144210790|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.95|||||TWO_SIDED|95.0|-5.17|-0.72||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.72|-5.17|
72343779|NCT01393639|144210790|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.44|||||TWO_SIDED|95.0|-5.65|-1.23||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-1.23|-5.65|
72343780|NCT01393639|144210790|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.32|||||TWO_SIDED|95.0|-5.52|-1.12||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-1.12|-5.52|
72343781|NCT01393639|144210790|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.39|||||TWO_SIDED|95.0|-4.6|-0.18||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.18|-4.60|
72343782|NCT01393639|144210790|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.87|||||TWO_SIDED|95.0|-6.07|-1.68||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-1.68|-6.07|
72343783|NCT01393639|144210790|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.62|||||TWO_SIDED|95.0|-0.1|3.34||||||Week 2 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||3.34|-0.10|
72343784|NCT01393639|144210790|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.34|||||TWO_SIDED|95.0|-1.36|2.05||||||Week 2 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||2.05|-1.36|
72343785|NCT01393639|144210790|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.77|||||TWO_SIDED|95.0|-0.94|2.48||||||Week 2 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||2.48|-0.94|
72343786|NCT01393639|144210790|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.31|||||TWO_SIDED|95.0|-2.01|1.38||||||Week 2 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||1.38|-2.01|
72370132|NCT01485172|144250631|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.39||||0.102|TWO_SIDED|95.0|-0.86|0.08||P-values are from a Mixed Model Repeated Measures analysis.|Mixed Models Analysis|||||0.08|-0.86|0.102
72370133|NCT01485172|144250631|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.06||||0.723|TWO_SIDED|95.0|-0.41|0.29||P-values are from a Mixed Model Repeated Measures analysis.|Mixed Models Analysis|||||0.29|-0.41|0.723
72370134|NCT01485172|144250631|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.31||||0.084|TWO_SIDED|95.0|-0.66|0.04||P-values are from a Mixed Model Repeated Measures analysis.|Mixed Models Analysis|||||0.04|-0.66|0.084
72370135|NCT01485172|144250631|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.07||||0.697|TWO_SIDED|95.0|-0.42|0.28||P-values are from a Mixed Model Repeated Measures analysis.|Mixed Models Analysis|||||0.28|-0.42|0.697
72370136|NCT01485172|144250631|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.45||||0.086|TWO_SIDED|95.0|-0.06|0.97||P-values are from a Mixed Model Repeated Measures analysis.|Mixed Models Analysis|||||0.97|-0.06|0.086
72370137|NCT01485172|144250632|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.769||||0.733|TWO_SIDED|95.0|0.17|3.49|||Generalized Estimating Equations model|||||3.49|0.17|0.733
72370138|NCT01485172|144250632|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.411||||0.519|TWO_SIDED|95.0|0.5|4.02|||Generalized Estimating Equations model|||||4.02|0.50|0.519
72370139|NCT01485172|144250632|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.204||||0.008|TWO_SIDED|95.0|1.46|12.07|||Generalized Estimating Equations model|||||12.07|1.46|0.008
72343787|NCT01393639|144210790|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.17|||||TWO_SIDED|95.0|-0.79|3.12||||||Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||3.12|-0.79|
72343788|NCT01393639|144210790|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.86|||||TWO_SIDED|95.0|-1.1|2.82||||||Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||2.82|-1.10|
72343789|NCT01393639|144210790|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.76|||||TWO_SIDED|95.0|-1.19|2.72||||||Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||2.72|-1.19|
72343790|NCT01393639|144210790|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.29|||||TWO_SIDED|95.0|-2.24|1.66||||||Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||1.66|-2.24|
72343791|NCT01393639|144210790|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.76|||||TWO_SIDED|95.0|-0.16|3.67||||||Week 6 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||3.67|-0.16|
72343792|NCT01393639|144210790|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.12|||||TWO_SIDED|95.0|-0.81|3.04||||||Week 6 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||3.04|-0.81|
72343793|NCT01393639|144210790|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.66|||||TWO_SIDED|95.0|-1.26|2.57||||||Week 6 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||2.57|-1.26|
72343794|NCT01393639|144210790|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.34|||||TWO_SIDED|95.0|-1.57|2.25||||||Week 6 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||2.25|-1.57|
72343795|NCT01393639|144210790|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.88|||||TWO_SIDED|95.0|-0.31|4.07||||||Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||4.07|-0.31|
72428672|NCT03699124|144368385|EQUIVALENCE|Equivalence between two lot groups is demonstrated if the confidence interval of the ratio of the GMTs lies within the interval \[½, 2\]. For the trial to be successful, all three lot group comparisons must be equivalent by this definition.|GMT Ratio|0.936|||||TWO_SIDED|95.0|0.816|1.073||||||||1.073|0.816|
72428673|NCT03699124|144368385|EQUIVALENCE|Equivalence between two lot groups is demonstrated if the confidence interval of the ratio of the GMTs lies within the interval \[½, 2\]. For the trial to be successful, all three lot group comparisons must be equivalent by this definition.|GMT Ratio|1.115|||||TWO_SIDED|95.0|0.967|1.287||||||||1.287|0.967|
72343796|NCT01393639|144210790|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.93|||||TWO_SIDED|95.0|-1.28|3.13||||||Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||3.13|-1.28|
72343797|NCT01393639|144210790|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.43|||||TWO_SIDED|95.0|-1.76|2.62||||||Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||2.62|-1.76|
72343798|NCT01393639|144210790|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.55|||||TWO_SIDED|95.0|-1.63|2.74||||||Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||2.74|-1.63|
72343799|NCT01393639|144210792|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.49|||||TWO_SIDED|95.0|-12.52|3.55||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||3.55|-12.52|
72343800|NCT01393639|144210792|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-10.15|||||TWO_SIDED|95.0|-18.1|-2.2||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-2.20|-18.10|
72343801|NCT01393639|144210792|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-10.93|||||TWO_SIDED|95.0|-18.94|-2.92||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-2.92|-18.94|
72343802|NCT01393639|144210792|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-16.12|||||TWO_SIDED|95.0|-24.01|-8.24||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-8.24|-24.01|
72343803|NCT01393639|144210792|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.45|||||TWO_SIDED|95.0|-13.45|2.56||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||2.56|-13.45|
72343804|NCT01393639|144210792|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-14.1|||||TWO_SIDED|95.0|-22.09|-6.11||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-6.11|-22.09|
72343805|NCT01393639|144210792|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.42|||||TWO_SIDED|95.0|-11.13|4.29||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||4.29|-11.13|
72343806|NCT01393639|144210792|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-7.98|||||TWO_SIDED|95.0|-15.7|-0.26||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.26|-15.70|
72343807|NCT01393639|144210792|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.17|||||TWO_SIDED|95.0|-12.93|2.59||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||2.59|-12.93|
72343808|NCT01393639|144210792|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-10.22|||||TWO_SIDED|95.0|-17.9|-2.54||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-2.54|-17.90|
72343809|NCT01393639|144210792|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.43|||||TWO_SIDED|95.0|-5.32|10.19||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||10.19|-5.32|
72343810|NCT01393639|144210792|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-11.14|||||TWO_SIDED|95.0|-18.83|-3.45||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-3.45|-18.83|
72343811|NCT01393639|144210792|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.42|||||TWO_SIDED|95.0|-12.44|1.59||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||1.59|-12.44|
72343812|NCT01393639|144210792|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-12.24|||||TWO_SIDED|95.0|-19.27|-5.2||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-5.20|-19.27|
72343813|NCT01393639|144210792|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-9.13|||||TWO_SIDED|95.0|-16.11|-2.14||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-2.14|-16.11|
72343814|NCT01393639|144210792|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-9.88|||||TWO_SIDED|95.0|-16.89|-2.88||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-2.88|-16.89|
72343815|NCT01393639|144210792|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.61|||||TWO_SIDED|95.0|-9.63|4.4||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||4.40|-9.63|
72343816|NCT01393639|144210792|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-12.93|||||TWO_SIDED|95.0|-19.88|-5.98||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-5.98|-19.88|
72343817|NCT01393639|144210792|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.1|||||TWO_SIDED|95.0|-10.03|3.83||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||3.83|-10.03|
72343818|NCT01393639|144210792|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-10.1|||||TWO_SIDED|95.0|-17.06|-3.13||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-3.13|-17.06|
72343819|NCT01393639|144210792|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-10.67|||||TWO_SIDED|95.0|-17.57|-3.77||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-3.77|-17.57|
72370140|NCT01485172|144250632|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.456||||0.001|TWO_SIDED|95.0|1.93|15.46|||Generalized Estimating Equations model|||||15.46|1.93|0.001
72370141|NCT01485172|144250632|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.281||||0.752|TWO_SIDED|95.0|0.27|5.98|||Generalized Estimating Equations model|||||5.98|0.27|0.752
72370142|NCT02283762|144250644|SUPERIORITY||Difference of LS means|-2.34||||0.0815|TWO_SIDED|95.0|-4.99|0.3|||MMRM (Method 1)|||||0.30|-4.99|0.0815
72343820|NCT01393639|144210792|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-7.79|||||TWO_SIDED|95.0|-14.72|-0.86||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.86|-14.72|
72343821|NCT01393639|144210792|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.05|||||TWO_SIDED|95.0|-9.98|3.89||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||3.89|-9.98|
72343822|NCT01393639|144210792|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-13.41|||||TWO_SIDED|95.0|-20.27|-6.54||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-6.54|-20.27|
72343823|NCT01393639|144210792|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|9.61|||||TWO_SIDED|95.0|1.62|17.61||||||Week 2 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||17.61|1.62|
72343824|NCT01393639|144210792|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.95|||||TWO_SIDED|95.0|-3.96|11.85||||||Week 2 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||11.85|-3.96|
72343825|NCT01393639|144210792|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.17|||||TWO_SIDED|95.0|-4.8|11.13||||||Week 2 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||11.13|-4.80|
72343826|NCT01393639|144210792|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.03|||||TWO_SIDED|95.0|-9.86|5.81||||||Week 2 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||5.81|-9.86|
72343827|NCT01393639|144210792|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|7.72|||||TWO_SIDED|95.0|0.03|15.42||||||Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||15.42|0.03|
72343828|NCT01393639|144210792|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.16|||||TWO_SIDED|95.0|-4.54|10.87||||||Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||10.87|-4.54|
72343829|NCT01393639|144210792|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.97|||||TWO_SIDED|95.0|-1.77|13.71||||||Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||13.71|-1.77|
72343830|NCT01393639|144210792|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.92|||||TWO_SIDED|95.0|-6.75|8.59||||||Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||8.59|-6.75|
72343831|NCT01393639|144210792|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|7.5|||||TWO_SIDED|95.0|0.57|14.43||||||Week 6 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||14.43|0.57|
72343832|NCT01393639|144210792|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.69|||||TWO_SIDED|95.0|-6.26|7.64||||||Week 6 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||7.64|-6.26|
72343833|NCT01393639|144210792|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.8|||||TWO_SIDED|95.0|-3.09|10.7||||||Week 6 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||10.70|-3.09|
72343834|NCT01393639|144210792|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.05|||||TWO_SIDED|95.0|-3.87|9.96||||||Week 6 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||9.96|-3.87|
72343835|NCT01393639|144210792|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|10.31|||||TWO_SIDED|95.0|3.43|17.18||||||Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||17.18|3.43|
72343836|NCT01393639|144210792|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.31|||||TWO_SIDED|95.0|-3.59|10.22||||||Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||10.22|-3.59|
72343837|NCT01393639|144210792|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.73|||||TWO_SIDED|95.0|-4.1|9.57||||||Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||9.57|-4.10|
72343838|NCT01393639|144210792|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.62|||||TWO_SIDED|95.0|-1.25|12.48||||||Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||12.48|-1.25|
72343839|NCT01393639|144210794|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.38|||||TWO_SIDED|95.0|-7.56|8.31||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||8.31|-7.56|
72343840|NCT01393639|144210794|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-8.15|||||TWO_SIDED|95.0|-16.01|-0.3||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.30|-16.01|
72343841|NCT01393639|144210794|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-14.1|||||TWO_SIDED|95.0|-22.01|-6.2||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-6.20|-22.01|
72343842|NCT01393639|144210794|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-11.88|||||TWO_SIDED|95.0|-19.7|-4.06||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-4.06|-19.70|
72343843|NCT01393639|144210794|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.58|||||TWO_SIDED|95.0|-7.33|8.48||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||8.48|-7.33|
72343844|NCT01393639|144210794|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-12.89|||||TWO_SIDED|95.0|-20.8|-4.98||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-4.98|-20.80|
72343845|NCT01393639|144210794|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.37|||||TWO_SIDED|95.0|-9.31|8.58||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||8.58|-9.31|
72343846|NCT01393639|144210794|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-9.48|||||TWO_SIDED|95.0|-18.43|-0.53||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.53|-18.43|
72343847|NCT01393639|144210794|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-13.42|||||TWO_SIDED|95.0|-22.39|-4.44||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-4.44|-22.39|
72343848|NCT01393639|144210794|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-8.58|||||TWO_SIDED|95.0|-17.48|0.33||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.33|-17.48|
72343849|NCT01393639|144210794|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.6|||||TWO_SIDED|95.0|-11.57|6.38||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||6.38|-11.57|
72343850|NCT01393639|144210794|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-13.75|||||TWO_SIDED|95.0|-22.73|-4.78||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-4.78|-22.73|
72343851|NCT01393639|144210794|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.22|||||TWO_SIDED|95.0|-9.32|8.88||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||8.88|-9.32|
72343852|NCT01393639|144210794|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-12.28|||||TWO_SIDED|95.0|-21.39|-3.17||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-3.17|-21.39|
72343853|NCT01393639|144210794|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-16.44|||||TWO_SIDED|95.0|-25.53|-7.36||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-7.36|-25.53|
72343854|NCT01393639|144210794|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-9.38|||||TWO_SIDED|95.0|-18.42|-0.34||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.34|-18.42|
72370143|NCT02283762|144250645|SUPERIORITY|The pre-specified test was for superiority but ONLY if the primary endpoint and secondary endpoints were meeting statistical significance (hierarchical testing).|%|0.2||||0.977|TWO_SIDED|95.0|-13.68|14.09|||Mantel Haenszel|||||14.09|-13.68|0.9770
72370144|NCT02283762|144250646|SUPERIORITY|The pre-specified test was for superiority but ONLY if the primary endpoint and secondary endpoints were meeting statistical significance (hierarchical testing).|Difference in LS means|-0.07||||0.3529|TWO_SIDED|95.0|-0.23|0.08|||MMRM (Method 1)|||change from baseline||0.08|-0.23|0.3529
72343855|NCT01393639|144210794|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.52|||||TWO_SIDED|95.0|-13.61|4.57||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||4.57|-13.61|
72343856|NCT01393639|144210794|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-13.78|||||TWO_SIDED|95.0|-22.87|-4.69||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-4.69|-22.87|
72343857|NCT01393639|144210794|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.85|||||TWO_SIDED|95.0|-7.9|11.6||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||11.60|-7.90|
72343858|NCT01393639|144210794|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-10.72|||||TWO_SIDED|95.0|-20.51|-0.93||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.93|-20.51|
72343859|NCT01393639|144210794|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-18.52|||||TWO_SIDED|95.0|-28.28|-8.77||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-8.77|-28.28|
72343860|NCT01393639|144210794|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-12.96|||||TWO_SIDED|95.0|-22.67|-3.25||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-3.25|-22.67|
72343861|NCT01393639|144210794|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-7.46|||||TWO_SIDED|95.0|-17.21|2.3||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||2.30|-17.21|
72343862|NCT01393639|144210794|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-16.24|||||TWO_SIDED|95.0|-26.0|-6.48||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-6.48|-26.00|
72343863|NCT01393639|144210794|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|13.27|||||TWO_SIDED|95.0|5.34|21.2||||||Week 2 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||21.20|5.34|
72343864|NCT01393639|144210794|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.74|||||TWO_SIDED|95.0|-3.12|12.59||||||Week 2 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||12.59|-3.12|
72343865|NCT01393639|144210794|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.21|||||TWO_SIDED|95.0|-9.1|6.68||||||Week 2 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||6.68|-9.10|
72343866|NCT01393639|144210794|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.01|||||TWO_SIDED|95.0|-6.79|8.81||||||Week 2 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||8.81|-6.79|
72343867|NCT01393639|144210794|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|13.39|||||TWO_SIDED|95.0|4.39|22.38||||||Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||22.38|4.39|
72343868|NCT01393639|144210794|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.27|||||TWO_SIDED|95.0|-4.73|13.27||||||Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||13.27|-4.73|
72343869|NCT01393639|144210794|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.34|||||TWO_SIDED|95.0|-8.68|9.35||||||Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||9.35|-8.68|
72343870|NCT01393639|144210794|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.18|||||TWO_SIDED|95.0|-3.77|14.12||||||Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||14.12|-3.77|
72343871|NCT01393639|144210794|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|13.56|||||TWO_SIDED|95.0|4.44|22.68||||||Week 6 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||22.68|4.44|
72343872|NCT01393639|144210794|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.5|||||TWO_SIDED|95.0|-7.64|10.64||||||Week 6 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||10.64|-7.64|
72343873|NCT01393639|144210794|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.66|||||TWO_SIDED|95.0|-11.76|6.44||||||Week 6 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||6.44|-11.76|
72343874|NCT01393639|144210794|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.41|||||TWO_SIDED|95.0|-4.65|13.46||||||Week 6 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||13.46|-4.65|
72343875|NCT01393639|144210794|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|18.09|||||TWO_SIDED|95.0|8.34|27.84||||||Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||27.84|8.34|
72343876|NCT01393639|144210794|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.52|||||TWO_SIDED|95.0|-4.27|15.32||||||Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||15.32|-4.27|
72343877|NCT01393639|144210794|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.28|||||TWO_SIDED|95.0|-12.03|7.46||||||Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||7.46|-12.03|
72428674|NCT03699124|144368385|EQUIVALENCE|Equivalence between two lot groups is demonstrated if the confidence interval of the ratio of the GMTs lies within the interval \[½, 2\]. For the trial to be successful, all three lot group comparisons must be equivalent by this definition.|GMT Ratio|1.044|||||TWO_SIDED|95.0|0.915|1.191||||||||1.191|0.915|
72343878|NCT01393639|144210794|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.28|||||TWO_SIDED|95.0|-6.42|12.98||||||Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||12.98|-6.42|
72343879|NCT01393639|144210796|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-7.06|||||TWO_SIDED|95.0|-14.07|-0.06||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.06|-14.07|
72343880|NCT01393639|144210796|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-12.45|||||TWO_SIDED|95.0|-19.34|-5.56||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-5.56|-19.34|
72343881|NCT01393639|144210796|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-12.85|||||TWO_SIDED|95.0|-19.79|-5.91||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-5.91|-19.79|
72343882|NCT01393639|144210796|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-15.92|||||TWO_SIDED|95.0|-22.79|-9.06||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-9.06|-22.79|
72343883|NCT01393639|144210796|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.95|||||TWO_SIDED|95.0|-10.89|2.99||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||2.99|-10.89|
72343884|NCT01393639|144210796|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-13.51|||||TWO_SIDED|95.0|-20.44|-6.57||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-6.57|-20.44|
72343885|NCT01393639|144210796|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-7.25|||||TWO_SIDED|95.0|-14.65|0.16||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.16|-14.65|
72343886|NCT01393639|144210796|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-12.03|||||TWO_SIDED|95.0|-19.38|-4.68||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-4.68|-19.38|
72343887|NCT01393639|144210796|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-15.72|||||TWO_SIDED|95.0|-23.1|-8.35||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-8.35|-23.10|
72343888|NCT01393639|144210796|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-13.95|||||TWO_SIDED|95.0|-21.27|-6.63||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-6.63|-21.27|
72343889|NCT01393639|144210796|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.94|||||TWO_SIDED|95.0|-13.31|1.43||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||1.43|-13.31|
72428675|NCT03748979|144368427|SUPERIORITY||||||<|0.0001||||||P-value was obtained using MMRM analysis. The p-value for each treatment group is for the comparison of that treatment group to the placebo treatment group on Day 1.|Mixed Model for Repeated Measures (MMRM)|||||||<0.0001
72343890|NCT01393639|144210796|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-16.16|||||TWO_SIDED|95.0|-23.54|-8.79||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-8.79|-23.54|
72343891|NCT01393639|144210796|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.09|||||TWO_SIDED|95.0|-13.5|1.32||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||1.32|-13.50|
72343892|NCT01393639|144210796|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-13.06|||||TWO_SIDED|95.0|-20.46|-5.65||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-5.65|-20.46|
72343893|NCT01393639|144210796|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-15.31|||||TWO_SIDED|95.0|-22.69|-7.93||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-7.93|-22.69|
72343894|NCT01393639|144210796|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-13.31|||||TWO_SIDED|95.0|-20.66|-5.96||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-5.96|-20.66|
72343895|NCT01393639|144210796|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-9.06|||||TWO_SIDED|95.0|-16.44|-1.68||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-1.68|-16.44|
72343896|NCT01393639|144210796|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-14.44|||||TWO_SIDED|95.0|-21.82|-7.06||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-7.06|-21.82|
72343897|NCT01393639|144210796|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.72|||||TWO_SIDED|95.0|-12.53|3.09||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||3.09|-12.53|
72343898|NCT01393639|144210796|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-12.4|||||TWO_SIDED|95.0|-20.21|-4.59||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-4.59|-20.21|
72343899|NCT01393639|144210796|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-16.48|||||TWO_SIDED|95.0|-24.25|-8.71||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-8.71|-24.25|
72343900|NCT01393639|144210796|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-12.19|||||TWO_SIDED|95.0|-19.94|-4.44||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-4.44|-19.94|
72343901|NCT01393639|144210796|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-7.73|||||TWO_SIDED|95.0|-15.5|0.04||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.04|-15.50|
72343902|NCT01393639|144210796|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-13.98|||||TWO_SIDED|95.0|-21.75|-6.21||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-6.21|-21.75|
72343903|NCT01393639|144210796|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|6.45|||||TWO_SIDED|95.0|-0.53|13.42||||||Week 2 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||13.42|-0.53|
72343904|NCT01393639|144210796|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.06|||||TWO_SIDED|95.0|-5.81|7.92||||||Week 2 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||7.92|-5.81|
72343905|NCT01393639|144210796|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.66|||||TWO_SIDED|95.0|-6.25|7.57||||||Week 2 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||7.57|-6.25|
72343906|NCT01393639|144210796|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.42|||||TWO_SIDED|95.0|-9.26|4.42||||||Week 2 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||4.42|-9.26|
72343907|NCT01393639|144210796|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|8.91|||||TWO_SIDED|95.0|1.48|16.35||||||Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||16.35|1.48|
72343908|NCT01393639|144210796|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.13|||||TWO_SIDED|95.0|-3.24|11.51||||||Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||11.51|-3.24|
72343909|NCT01393639|144210796|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.44|||||TWO_SIDED|95.0|-6.96|7.84||||||Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||7.84|-6.96|
72343910|NCT01393639|144210796|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.21|||||TWO_SIDED|95.0|-5.14|9.56||||||Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||9.56|-5.14|
72343911|NCT01393639|144210796|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|8.35|||||TWO_SIDED|95.0|0.92|15.77||||||Week 6 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||15.77|0.92|
72343912|NCT01393639|144210796|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.38|||||TWO_SIDED|95.0|-6.03|8.8||||||Week 6 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||8.80|-6.03|
72343913|NCT01393639|144210796|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.87|||||TWO_SIDED|95.0|-8.26|6.52||||||Week 6 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||6.52|-8.26|
72343914|NCT01393639|144210796|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.13|||||TWO_SIDED|95.0|-6.23|8.49||||||Week 6 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||8.49|-6.23|
72343915|NCT01393639|144210796|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|9.26|||||TWO_SIDED|95.0|1.46|17.06||||||Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||17.06|1.46|
72343916|NCT01393639|144210796|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.58|||||TWO_SIDED|95.0|-6.23|9.38||||||Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||9.38|-6.23|
72343917|NCT01393639|144210796|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.5|||||TWO_SIDED|95.0|-10.27|5.27||||||Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||5.27|-10.27|
72343918|NCT01393639|144210796|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.79|||||TWO_SIDED|95.0|-5.95|9.53||||||Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||9.53|-5.95|
72343919|NCT01393639|144210798|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.87|||||TWO_SIDED|95.0|-10.89|5.14||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||5.14|-10.89|
72343920|NCT01393639|144210798|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.86|||||TWO_SIDED|95.0|-14.8|1.08||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||1.08|-14.80|
72343921|NCT01393639|144210798|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-14.36|||||TWO_SIDED|95.0|-22.34|-6.38||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-6.38|-22.34|
72343922|NCT01393639|144210798|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-12.32|||||TWO_SIDED|95.0|-20.22|-4.41||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-4.41|-20.22|
72343923|NCT01393639|144210798|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.14|||||TWO_SIDED|95.0|-10.12|5.85||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||5.85|-10.12|
72343924|NCT01393639|144210798|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-14.05|||||TWO_SIDED|95.0|-22.05|-6.04||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-6.04|-22.05|
72343925|NCT01393639|144210798|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.26|||||TWO_SIDED|95.0|-9.83|7.3||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||7.30|-9.83|
72343926|NCT01393639|144210798|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-10.1|||||TWO_SIDED|95.0|-18.67|-1.53||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-1.53|-18.67|
72343927|NCT01393639|144210798|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-15.41|||||TWO_SIDED|95.0|-24.01|-6.82||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-6.82|-24.01|
72343928|NCT01393639|144210798|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-11.79|||||TWO_SIDED|95.0|-20.33|-3.26||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-3.26|-20.33|
72343929|NCT01393639|144210798|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.98|||||TWO_SIDED|95.0|-14.57|2.62||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||2.62|-14.57|
72343930|NCT01393639|144210798|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-15.37|||||TWO_SIDED|95.0|-23.98|-6.76||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-6.76|-23.98|
72343931|NCT01393639|144210798|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.23|||||TWO_SIDED|95.0|-9.49|9.03||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||9.03|-9.49|
72343932|NCT01393639|144210798|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-10.36|||||TWO_SIDED|95.0|-19.64|-1.08||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-1.08|-19.64|
72343933|NCT01393639|144210798|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-15.57|||||TWO_SIDED|95.0|-24.83|-6.32||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-6.32|-24.83|
72343934|NCT01393639|144210798|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-11.34|||||TWO_SIDED|95.0|-20.56|-2.13||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-2.13|-20.56|
72343935|NCT01393639|144210798|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.36|||||TWO_SIDED|95.0|-14.61|3.89||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||3.89|-14.61|
72343936|NCT01393639|144210798|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-15.88|||||TWO_SIDED|95.0|-25.15|-6.61||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-6.61|-25.15|
72343937|NCT01393639|144210798|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.69|||||TWO_SIDED|95.0|-10.32|8.94||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||8.94|-10.32|
72343938|NCT01393639|144210798|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-10.27|||||TWO_SIDED|95.0|-19.95|-0.59||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.59|-19.95|
72343939|NCT01393639|144210798|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-19.7|||||TWO_SIDED|95.0|-29.34|-10.06||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-10.06|-29.34|
72343940|NCT01393639|144210798|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-12.65|||||TWO_SIDED|95.0|-22.25|-3.04||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-3.04|-22.25|
72343941|NCT01393639|144210798|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-7.6|||||TWO_SIDED|95.0|-17.24|2.04||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||2.04|-17.24|
72343942|NCT01393639|144210798|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-19.34|||||TWO_SIDED|95.0|-28.99|-9.68||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-9.68|-28.99|
72343943|NCT01393639|144210798|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|11.17|||||TWO_SIDED|95.0|3.18|19.16||||||Week 2 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||19.16|3.18|
72428676|NCT03748979|144368427|SUPERIORITY||||||<|0.0001||||||P-value was obtained using MMRM analysis. The p-value for each treatment group is for the comparison of that treatment group to the placebo treatment group on Day 1.|MMRM|||||||<0.0001
72343944|NCT01393639|144210798|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|7.19|||||TWO_SIDED|95.0|-0.78|15.15||||||Week 2 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||15.15|-0.78|
72343945|NCT01393639|144210798|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.31|||||TWO_SIDED|95.0|-8.28|7.65||||||Week 2 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||7.65|-8.28|
72343946|NCT01393639|144210798|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.73|||||TWO_SIDED|95.0|-6.14|9.61||||||Week 2 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||9.61|-6.14|
72343947|NCT01393639|144210798|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|14.11|||||TWO_SIDED|95.0|5.51|22.71||||||Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||22.71|5.51|
72343948|NCT01393639|144210798|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.27|||||TWO_SIDED|95.0|-3.38|13.92||||||Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||13.92|-3.38|
72343949|NCT01393639|144210798|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.04|||||TWO_SIDED|95.0|-8.68|8.59||||||Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||8.59|-8.68|
72428677|NCT03748979|144368427|SUPERIORITY|||||||0.0002||||||P-value was obtained using MMRM analysis. The p-value for each treatment group is for the comparison of that treatment group to the placebo treatment group on Day 7.|MMRM|||||||0.0002
72343950|NCT01393639|144210798|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.58|||||TWO_SIDED|95.0|-4.99|12.15||||||Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||12.15|-4.99|
72343951|NCT01393639|144210798|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|15.65|||||TWO_SIDED|95.0|6.38|24.93||||||Week 6 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||24.93|6.38|
72343952|NCT01393639|144210798|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.53|||||TWO_SIDED|95.0|-3.81|14.86||||||Week 6 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||14.86|-3.81|
72343953|NCT01393639|144210798|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.31|||||TWO_SIDED|95.0|-8.97|9.59||||||Week 6 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||9.59|-8.97|
72343954|NCT01393639|144210798|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.54|||||TWO_SIDED|95.0|-4.69|13.77||||||Week 6 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||13.77|-4.69|
72343955|NCT01393639|144210798|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|18.65|||||TWO_SIDED|95.0|9.03|28.27||||||Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||28.27|9.03|
72343956|NCT01393639|144210798|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|9.07|||||TWO_SIDED|95.0|-0.64|18.78||||||Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||18.78|-0.64|
72343957|NCT01393639|144210798|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.36|||||TWO_SIDED|95.0|-10.0|9.28||||||Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||9.28|-10.00|
72343958|NCT01393639|144210798|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|6.69|||||TWO_SIDED|95.0|-2.91|16.29||||||Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||16.29|-2.91|
72343959|NCT01393639|144210800|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.19|||||TWO_SIDED|95.0|-0.37|-0.02||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.02|-0.37|
72343960|NCT01393639|144210800|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.29|||||TWO_SIDED|95.0|-0.46|-0.11||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.11|-0.46|
72428678|NCT03748979|144368427|SUPERIORITY||||||<|0.0001||||||P-value was obtained using MMRM analysis. The p-value for each treatment group is for the comparison of that treatment group to the placebo treatment group on Day 7.|MMRM|||||||<0.0001
72343961|NCT01393639|144210800|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.28|||||TWO_SIDED|95.0|-0.45|-0.1||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.10|-0.45|
72343962|NCT01393639|144210800|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.35|||||TWO_SIDED|95.0|-0.52|-0.18||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.18|-0.52|
72343963|NCT01393639|144210800|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.17|||||TWO_SIDED|95.0|-0.35|0.0||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.00|-0.35|
72343964|NCT01393639|144210800|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.36|||||TWO_SIDED|95.0|-0.53|-0.18||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.18|-0.53|
72343965|NCT01393639|144210800|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.12|||||TWO_SIDED|95.0|-0.31|0.07||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.07|-0.31|
72343966|NCT01393639|144210800|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.36|||||TWO_SIDED|95.0|-0.54|-0.17||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.17|-0.54|
72343967|NCT01393639|144210800|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.28|||||TWO_SIDED|95.0|-0.47|-0.09||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.09|-0.47|
72343968|NCT01393639|144210800|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.37|||||TWO_SIDED|95.0|-0.56|-0.18||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.18|-0.56|
72343969|NCT01393639|144210800|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.2|||||TWO_SIDED|95.0|-0.39|-0.01||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.01|-0.39|
72343970|NCT01393639|144210800|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.44|||||TWO_SIDED|95.0|-0.63|-0.25||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.25|-0.63|
72343971|NCT01393639|144210800|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.14|||||TWO_SIDED|95.0|-0.34|0.05||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.05|-0.34|
72343972|NCT01393639|144210800|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.4|||||TWO_SIDED|95.0|-0.59|-0.2||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.20|-0.59|
72343973|NCT01393639|144210800|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.32|||||TWO_SIDED|95.0|-0.51|-0.12||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.12|-0.51|
72343974|NCT01393639|144210800|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.35|||||TWO_SIDED|95.0|-0.55|-0.16||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.16|-0.55|
72343975|NCT01393639|144210800|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.18|||||TWO_SIDED|95.0|-0.38|0.01||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.01|-0.38|
72343976|NCT01393639|144210800|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.47|||||TWO_SIDED|95.0|-0.67|-0.27||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.27|-0.67|
72343977|NCT01393639|144210800|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.07|||||TWO_SIDED|95.0|-0.3|0.15||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.15|-0.30|
72428679|NCT03748979|144368427|SUPERIORITY||||||<|0.0001||||||P-value was obtained using MMRM analysis. The p-value for each treatment group is for the comparison of that treatment group to the placebo treatment group on Day 1.|MMRM|||||||<0.0001
72343978|NCT01393639|144210800|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.4|||||TWO_SIDED|95.0|-0.63|-0.18||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.18|-0.63|
72343979|NCT01393639|144210800|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.41|||||TWO_SIDED|95.0|-0.64|-0.18||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.18|-0.64|
72343980|NCT01393639|144210800|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.36|||||TWO_SIDED|95.0|-0.59|-0.14||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.14|-0.59|
72343981|NCT01393639|144210800|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.32|||||TWO_SIDED|95.0|-0.54|-0.09||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.09|-0.54|
72343982|NCT01393639|144210800|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.58|||||TWO_SIDED|95.0|-0.81|-0.35||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.35|-0.81|
72343983|NCT01393639|144210800|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.16|||||TWO_SIDED|95.0|-0.01|0.34||||||Week 2 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.34|-0.01|
72343984|NCT01393639|144210800|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.07|||||TWO_SIDED|95.0|-0.1|0.24||||||Week 2 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.24|-0.10|
72343985|NCT01393639|144210800|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.08|||||TWO_SIDED|95.0|-0.1|0.25||||||Week 2 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.25|-0.10|
72343986|NCT01393639|144210800|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0|||||TWO_SIDED|95.0|-0.17|0.18||||||Week 2 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.18|-0.17|
72343987|NCT01393639|144210800|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.32|||||TWO_SIDED|95.0|0.13|0.51||||||Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.51|0.13|
72343988|NCT01393639|144210800|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.08|||||TWO_SIDED|95.0|-0.11|0.27||||||Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.27|-0.11|
72343989|NCT01393639|144210800|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.15|||||TWO_SIDED|95.0|-0.04|0.34||||||Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.34|-0.04|
72343990|NCT01393639|144210800|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.06|||||TWO_SIDED|95.0|-0.13|0.25||||||Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.25|-0.13|
72343991|NCT01393639|144210800|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.32|||||TWO_SIDED|95.0|0.13|0.52||||||Week 6 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.52|0.13|
72343992|NCT01393639|144210800|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.07|||||TWO_SIDED|95.0|-0.12|0.27||||||Week 6 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.27|-0.12|
72343993|NCT01393639|144210800|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.15|||||TWO_SIDED|95.0|-0.05|0.35||||||Week 6 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.35|-0.05|
72343994|NCT01393639|144210800|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.12|||||TWO_SIDED|95.0|-0.08|0.31||||||Week 6 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.31|-0.08|
72343995|NCT01393639|144210800|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.51|||||TWO_SIDED|95.0|0.28|0.73||||||Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.73|0.28|
72343996|NCT01393639|144210800|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.18|||||TWO_SIDED|95.0|-0.05|0.4||||||Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.40|-0.05|
72428680|NCT03748979|144368427|SUPERIORITY||||||<|0.0001||||||P-value was obtained using MMRM analysis. The p-value for each treatment group is for the comparison of that treatment group to the placebo treatment group on Day 1.|MMRM|||||||<0.0001
72343997|NCT01393639|144210800|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.17|||||TWO_SIDED|95.0|-0.06|0.4||||||Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.40|-0.06|
72428681|NCT03748979|144368427|SUPERIORITY||||||<|0.0001||||||P-value was obtained using MMRM analysis. The p-value for each treatment group is for the comparison of that treatment group to the placebo treatment group on Day 7.|MMRM|||||||<0.0001
72428682|NCT03748979|144368427|SUPERIORITY||||||<|0.0001||||||P-value was obtained using MMRM analysis. The p-value for each treatment group is for the comparison of that treatment group to the placebo treatment group on Day 7.|MMRM|||||||<0.0001
72428683|NCT03230864|144368454|SUPERIORITY||Mean Difference (Final Values)|5.47||||0.0809|TWO_SIDED|95.0|-0.7|11.65|||Mixed Model Repeated Measures|||The mean changes from randomization in PANNS total score was analysed using a mixed model for repeated measures (MMRM) approach. The model will include the fixed, categorical effects of treatment, strata, visit, treatment-by-visit interaction, fixed covariates of baseline scores and baseline scores-by-visit interaction. An unstructured (co)variance structure will be used to model the within-patient errors. The Kenward-Roger approximation will be used to estimate denominator degrees of freedom.||11.65|-0.70|0.0809
72428684|NCT01744496|144368470|SUPERIORITY_OR_OTHER||Least Square Mean|-0.76|STANDARD_ERROR_OF_MEAN|0.55||0.172|TWO_SIDED|95.0|-1.87|0.34|||ANCOVA|ANCOVA model for the change from Baseline to the End of Treatment containing treatment and region as factors and Baseline value as a covariate.||||0.34|-1.87|0.172
72428685|NCT01744496|144368472|SUPERIORITY_OR_OTHER||Least Square Mean|-8.01|STANDARD_ERROR_OF_MEAN|3.77||0.038|TWO_SIDED|95.0|-15.56|-0.46|||ANCOVA|ANCOVA model for the change from Baseline to the End of Treatment containing treatment and region as factors and Baseline value as a covariate.||||-0.46|-15.56|0.038
72428686|NCT01744496|144368473|SUPERIORITY_OR_OTHER||Least Square Mean|-1.02|STANDARD_ERROR_OF_MEAN|0.87||0.247|TWO_SIDED|95.0|-2.76|0.73|||ANCOVA|ANCOVA model for the change from Baseline to the End of Treatment containing treatment and region as factors and Baseline value as a covariate.||||0.73|-2.76|0.247
72428687|NCT01744496|144368474|SUPERIORITY_OR_OTHER||Least Square Mean|-0.58|STANDARD_ERROR_OF_MEAN|0.64||0.371|TWO_SIDED|95.0|-1.85|0.7|||ANCOVA|ANCOVA model for the change from Baseline to the End of Treatment containing treatment and region as factors and Baseline value as a covariate.||||0.70|-1.85|0.371
72428688|NCT01744496|144368475|SUPERIORITY_OR_OTHER||Least Square Mean|-2.82|STANDARD_ERROR_OF_MEAN|2.97||0.346|TWO_SIDED|95.0|-8.76|3.13|||ANCOVA|ANCOVA model for the change from Baseline to the End of Treatment containing treatment and region as factors and Baseline value as a covariate.||||3.13|-8.76|0.346
72343998|NCT01393639|144210800|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.22|||||TWO_SIDED|95.0|-0.01|0.44||||||Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.44|-0.01|
72428689|NCT01567163|144368478|SUPERIORITY_OR_OTHER||Ratio geometric least squares (LS) means|0.97|||||TWO_SIDED|90.0|0.84|1.1|||Mixed Models Analysis||The ratio of geometric LS means was calculated using a mixed effect model adjusted for cycle, participant and random error. Ratio of geometric LS means is AUC(0-∞) of Cycle 2/Cycle 1.|||1.10|0.84|
72428690|NCT01567163|144368480|SUPERIORITY_OR_OTHER||Ratio of geometric least squares means|1.14|||||TWO_SIDED|90.0|0.84|1.55|||Mixed Models Analysis||The ratio of geometric least squares means was calculated using a mixed effect model adjusted for cycle, participant and random error. Ratio of Geo LS mean is Cmax of Cycle 2/Cycle 1.|||1.55|0.84|
72428691|NCT03405662|144368484|SUPERIORITY|||||||0.07|||||||non-parametric Kolmogorov-Smirnov test|||||||0.07
72428692|NCT03405662|144368485|SUPERIORITY|||||||0.29|||||||non-parametric Kolmogorov-Smirnov test|||||||0.29
72428693|NCT03405662|144368486|SUPERIORITY|||||||0.07|||||||non-parametric Kolmogorov-Smirnov test|||||||0.07
72343999|NCT01393639|144210802|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.41|||||TWO_SIDED|95.0|-0.78|-0.04||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.04|-0.78|
72344000|NCT01393639|144210802|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.75|||||TWO_SIDED|95.0|-1.12|-0.39||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.39|-1.12|
72428694|NCT03405662|144368487|SUPERIORITY|||||||0.23|||||||non-parametric Kolmogorov-Smirnov test|||||||0.23
72428695|NCT03405662|144368488|SUPERIORITY|||||||0.68|||||||non-parametric Kolmogorov-Smirnov test|||||||0.68
72428696|NCT03405662|144368489|SUPERIORITY|||||||0.13|||||||non-parametric Kolmogorov-Smirnov test|||||||0.13
72428697|NCT03405662|144368490|SUPERIORITY|||||||0.32|||||||non-parametric Kolmogorov-Smirnov test|||||||0.32
72428698|NCT03405662|144368491|SUPERIORITY|||||||0.68|||||||non-parametric Kolmogorov-Smirnov test|||||||0.68
72428699|NCT03405662|144368492|SUPERIORITY|||||||0.86|||||||non-parametric Kolmogorov-Smirnov test|||||||0.86
72428700|NCT03405662|144368493|SUPERIORITY|||||||0.32|||||||non-parametric Kolmogorov-Smirnov test|||||||0.32
72428701|NCT01558674|144368566|SUPERIORITY_OR_OTHER||Difference in Least Squares (LS) Means|-98.5|||||TWO_SIDED|95.0|-138.0|-59.1|||Linear mixed effect model||8-mg MK-7145 LS Mean minus Furosemide LS Mean|||-59.1|-138.0|
72428702|NCT01558674|144368568|SUPERIORITY_OR_OTHER||Geometric Mean Ratio (GMR)|1.1|||||TWO_SIDED|90.0|0.99|1.22|||Mixed Linear Effects Model||GMR = Geometric mean (GM) MK-7145 8 mg divided by GM Furosemide|||1.22|0.99|
72428703|NCT04147260|144368580|EQUIVALENCE|Two-sided 90% CI with an acceptance range of -0.4 to 0.4|Mean Difference (Final Values)|0.09|STANDARD_ERROR_OF_MEAN|0.068|||TWO_SIDED|90.0|-0.03|0.2|||Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values||0.20|-0.03|
72428704|NCT04147260|144368580|EQUIVALENCE|Two-sided 90% CI with an acceptance range of -0.4 to 0.4|Mean Difference (Final Values)|0.04|STANDARD_ERROR_OF_MEAN|0.067|||TWO_SIDED|90.0|-0.07|0.16|||Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values||0.16|-0.07|
72344001|NCT01393639|144210802|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.81|||||TWO_SIDED|95.0|-1.18|-0.44||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.44|-1.18|
72344002|NCT01393639|144210802|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.11|||||TWO_SIDED|95.0|-1.48|-0.74||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.74|-1.48|
72344003|NCT01393639|144210802|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.35|||||TWO_SIDED|95.0|-0.72|0.02||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.02|-0.72|
72344004|NCT01393639|144210802|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.83|||||TWO_SIDED|95.0|-1.19|-0.46||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.46|-1.19|
72344005|NCT01393639|144210802|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.43|||||TWO_SIDED|95.0|-0.85|0.0||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.00|-0.85|
72344006|NCT01393639|144210802|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.73|||||TWO_SIDED|95.0|-1.15|-0.31||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.31|-1.15|
72344007|NCT01393639|144210802|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.95|||||TWO_SIDED|95.0|-1.37|-0.52||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.52|-1.37|
72344008|NCT01393639|144210802|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.96|||||TWO_SIDED|95.0|-1.39|-0.54||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.54|-1.39|
72344009|NCT01393639|144210802|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.24|||||TWO_SIDED|95.0|-0.67|0.18||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.18|-0.67|
72344010|NCT01393639|144210802|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.91|||||TWO_SIDED|95.0|-1.33|-0.49||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.49|-1.33|
72344011|NCT01393639|144210802|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.44|||||TWO_SIDED|95.0|-0.9|0.02||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.02|-0.90|
72344012|NCT01393639|144210802|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.87|||||TWO_SIDED|95.0|-1.32|-0.41||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.41|-1.32|
72344013|NCT01393639|144210802|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.07|||||TWO_SIDED|95.0|-1.53|-0.62||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.62|-1.53|
72344014|NCT01393639|144210802|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.05|||||TWO_SIDED|95.0|-1.51|-0.6||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.60|-1.51|
72344015|NCT01393639|144210802|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.43|||||TWO_SIDED|95.0|-0.89|0.03||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.03|-0.89|
72344016|NCT01393639|144210802|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.04|||||TWO_SIDED|95.0|-1.5|-0.59||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.59|-1.50|
72344017|NCT01393639|144210802|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.51|||||TWO_SIDED|95.0|-1.0|-0.03||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.03|-1.00|
72344018|NCT01393639|144210802|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.91|||||TWO_SIDED|95.0|-1.4|-0.43||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.43|-1.40|
72370145|NCT02283762|144250647|SUPERIORITY|The pre-specified test was for superiority but ONLY if the primary endpoint and secondary endpoints were meeting statistical significance (hierarchical testing).|Difference in LS means|0.79||||0.0887|TWO_SIDED|95.0|-0.12|1.69|||MMRM (Method 1)|||Change from baseline||1.69|-0.12|0.0887
72344019|NCT01393639|144210802|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.29|||||TWO_SIDED|95.0|-1.77|-0.8||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.80|-1.77|
72344020|NCT01393639|144210802|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.2|||||TWO_SIDED|95.0|-1.69|-0.72||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.72|-1.69|
72344021|NCT01393639|144210802|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.49|||||TWO_SIDED|95.0|-0.98|-0.01||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.01|-0.98|
72344022|NCT01393639|144210802|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.21|||||TWO_SIDED|95.0|-1.69|-0.73||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.73|-1.69|
72344023|NCT01393639|144210802|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.41|||||TWO_SIDED|95.0|0.04|0.78||||||Week 2 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.78|0.04|
72344024|NCT01393639|144210802|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.07|||||TWO_SIDED|95.0|-0.29|0.44||||||Week 2 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.44|-0.29|
72344025|NCT01393639|144210802|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.02|||||TWO_SIDED|95.0|-0.35|0.38||||||Week 2 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.38|-0.35|
72344026|NCT01393639|144210802|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.29|||||TWO_SIDED|95.0|-0.65|0.08||||||Week 2 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.08|-0.65|
72344027|NCT01393639|144210802|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.48|||||TWO_SIDED|95.0|0.06|0.91||||||Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.91|0.06|
72344028|NCT01393639|144210802|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.18|||||TWO_SIDED|95.0|-0.24|0.6||||||Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.60|-0.24|
72344029|NCT01393639|144210802|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.04|||||TWO_SIDED|95.0|-0.46|0.38||||||Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.38|-0.46|
72344030|NCT01393639|144210802|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.05|||||TWO_SIDED|95.0|-0.48|0.37||||||Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.37|-0.48|
72344031|NCT01393639|144210802|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.61|||||TWO_SIDED|95.0|0.15|1.06||||||Week 6 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||1.06|0.15|
72344032|NCT01393639|144210802|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.18|||||TWO_SIDED|95.0|-0.28|0.63||||||Week 6 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.63|-0.28|
72344033|NCT01393639|144210802|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.03|||||TWO_SIDED|95.0|-0.49|0.42||||||Week 6 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.42|-0.49|
72344034|NCT01393639|144210802|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.01|||||TWO_SIDED|95.0|-0.47|0.44||||||Week 6 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.44|-0.47|
72344035|NCT01393639|144210802|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.7|||||TWO_SIDED|95.0|0.22|1.18||||||Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||1.18|0.22|
72344036|NCT01393639|144210802|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.3|||||TWO_SIDED|95.0|-0.18|0.78||||||Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.78|-0.18|
72344037|NCT01393639|144210802|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.08|||||TWO_SIDED|95.0|-0.55|0.4||||||Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.40|-0.55|
72344038|NCT01393639|144210802|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.01|||||TWO_SIDED|95.0|-0.47|0.49||||||Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.49|-0.47|
72344039|NCT01393639|144210804|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.36|||||TWO_SIDED|95.0|-0.76|0.03||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.03|-0.76|
72344040|NCT01393639|144210804|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.78|||||TWO_SIDED|95.0|-1.17|-0.39||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.39|-1.17|
72344041|NCT01393639|144210804|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.93|||||TWO_SIDED|95.0|-1.32|-0.54||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.54|-1.32|
72344042|NCT01393639|144210804|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.17|||||TWO_SIDED|95.0|-1.56|-0.78||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.78|-1.56|
72344043|NCT01393639|144210804|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.3|||||TWO_SIDED|95.0|-0.7|0.09||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.09|-0.70|
72344044|NCT01393639|144210804|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.95|||||TWO_SIDED|95.0|-1.34|-0.55||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.55|-1.34|
72344045|NCT01393639|144210804|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.39|||||TWO_SIDED|95.0|-0.84|0.07||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.07|-0.84|
72344046|NCT01393639|144210804|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.78|||||TWO_SIDED|95.0|-1.23|-0.32||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.32|-1.23|
72344047|NCT01393639|144210804|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.06|||||TWO_SIDED|95.0|-1.52|-0.61||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.61|-1.52|
72344048|NCT01393639|144210804|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.0|||||TWO_SIDED|95.0|-1.45|-0.54||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.54|-1.45|
72428705|NCT04147260|144368580|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|-0.03|STANDARD_ERROR_OF_MEAN|0.055||0.572|TWO_SIDED|90.0|-0.14|0.08||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||0.08|-0.14|0.572
72344049|NCT01393639|144210804|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.25|||||TWO_SIDED|95.0|-0.71|0.21||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.21|-0.71|
72344050|NCT01393639|144210804|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.02|||||TWO_SIDED|95.0|-1.48|-0.57||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.57|-1.48|
72344051|NCT01393639|144210804|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.39|||||TWO_SIDED|95.0|-0.89|0.11||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.11|-0.89|
72344052|NCT01393639|144210804|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.94|||||TWO_SIDED|95.0|-1.44|-0.45||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.45|-1.44|
72344053|NCT01393639|144210804|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.21|||||TWO_SIDED|95.0|-1.71|-0.71||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.71|-1.71|
72344054|NCT01393639|144210804|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.09|||||TWO_SIDED|95.0|-1.59|-0.59||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.59|-1.59|
72344055|NCT01393639|144210804|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.45|||||TWO_SIDED|95.0|-0.95|0.05||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.05|-0.95|
72344056|NCT01393639|144210804|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.15|||||TWO_SIDED|95.0|-1.65|-0.66||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.66|-1.65|
72344057|NCT01393639|144210804|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.44|||||TWO_SIDED|95.0|-0.96|0.08||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.08|-0.96|
72344058|NCT01393639|144210804|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.96|||||TWO_SIDED|95.0|-1.48|-0.44||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.44|-1.48|
72344059|NCT01393639|144210804|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.43|||||TWO_SIDED|95.0|-1.94|-0.91||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.91|-1.94|
72344060|NCT01393639|144210804|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.28|||||TWO_SIDED|95.0|-1.8|-0.76||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.76|-1.80|
72344061|NCT01393639|144210804|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.55|||||TWO_SIDED|95.0|-1.06|-0.03||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.03|-1.06|
72344062|NCT01393639|144210804|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.33|||||TWO_SIDED|95.0|-1.85|-0.81||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.81|-1.85|
72344063|NCT01393639|144210804|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.59|||||TWO_SIDED|95.0|0.19|0.98||||||Week 2 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.98|0.19|
72344064|NCT01393639|144210804|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.17|||||TWO_SIDED|95.0|-0.22|0.56||||||Week 2 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.56|-0.22|
72344065|NCT01393639|144210804|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.02|||||TWO_SIDED|95.0|-0.38|0.41||||||Week 2 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.41|-0.38|
72344066|NCT01393639|144210804|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.23|||||TWO_SIDED|95.0|-0.62|0.16||||||Week 2 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.16|-0.62|
72344067|NCT01393639|144210804|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.64|||||TWO_SIDED|95.0|0.18|1.09||||||Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||1.09|0.18|
72344068|NCT01393639|144210804|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.24|||||TWO_SIDED|95.0|-0.21|0.7||||||Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.70|-0.21|
72428706|NCT04147260|144368580|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|0.08|STANDARD_ERROR_OF_MEAN|0.075||0.315|TWO_SIDED|90.0|-0.07|0.23||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||0.23|-0.07|0.315
72428707|NCT04147260|144368580|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|-0.06|STANDARD_ERROR_OF_MEAN|0.059||0.286|TWO_SIDED|90.0|-0.18|0.05||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||0.05|-0.18|0.286
72344069|NCT01393639|144210804|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.04|||||TWO_SIDED|95.0|-0.5|0.42||||||Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.42|-0.50|
72344070|NCT01393639|144210804|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.02|||||TWO_SIDED|95.0|-0.43|0.48||||||Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.48|-0.43|
72344071|NCT01393639|144210804|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.76|||||TWO_SIDED|95.0|0.26|1.26||||||Week 6 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||1.26|0.26|
72344072|NCT01393639|144210804|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.21|||||TWO_SIDED|95.0|-0.29|0.7||||||Week 6 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.70|-0.29|
72344073|NCT01393639|144210804|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.06|||||TWO_SIDED|95.0|-0.55|0.44||||||Week 6 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.44|-0.55|
72344074|NCT01393639|144210804|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.06|||||TWO_SIDED|95.0|-0.43|0.56||||||Week 6 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.56|-0.43|
72344075|NCT01393639|144210804|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.89|||||TWO_SIDED|95.0|0.37|1.41||||||Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||1.41|0.37|
72344076|NCT01393639|144210804|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.37|||||TWO_SIDED|95.0|-0.15|0.89||||||Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.89|-0.15|
72344077|NCT01393639|144210804|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.09|||||TWO_SIDED|95.0|-0.61|0.42||||||Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.42|-0.61|
72344078|NCT01393639|144210804|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.05|||||TWO_SIDED|95.0|-0.46|0.57||||||Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.57|-0.46|
72344079|NCT01393639|144210806|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.38|||||TWO_SIDED|95.0|-4.94|2.17||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||2.17|-4.94|
72344080|NCT01393639|144210806|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.45|||||TWO_SIDED|95.0|-3.98|3.08||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||3.08|-3.98|
72344081|NCT01393639|144210806|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.24|||||TWO_SIDED|95.0|-3.34|3.82||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||3.82|-3.34|
72344082|NCT01393639|144210806|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.76|||||TWO_SIDED|95.0|-2.75|4.28||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||4.28|-2.75|
72344083|NCT01393639|144210806|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.31|||||TWO_SIDED|95.0|-4.88|2.27||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||2.27|-4.88|
72344084|NCT01393639|144210806|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.25|||||TWO_SIDED|95.0|-1.32|5.82||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||5.82|-1.32|
72344085|NCT01393639|144210806|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.01|||||TWO_SIDED|95.0|-5.89|1.87||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||1.87|-5.89|
72344086|NCT01393639|144210806|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.49|||||TWO_SIDED|95.0|-2.41|5.4||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||5.40|-2.41|
72344087|NCT01393639|144210806|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.45|||||TWO_SIDED|95.0|-2.44|5.34||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||5.34|-2.44|
72370146|NCT02283762|144250648|SUPERIORITY|The pre-specified test was for superiority but ONLY if the primary endpoint and secondary endpoints were meeting statistical significance (hierarchical testing).|Difference in LS means|0.83||||0.0241|TWO_SIDED|95.0|0.11|1.54|||MMRM (Method 1)|||Change from baseline||1.54|0.11|0.0241
72344088|NCT01393639|144210806|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.89|||||TWO_SIDED|95.0|-1.98|5.76||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||5.76|-1.98|
72344089|NCT01393639|144210806|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.73|||||TWO_SIDED|95.0|-3.16|4.61||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||4.61|-3.16|
72344090|NCT01393639|144210806|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.18|||||TWO_SIDED|95.0|0.29|8.06||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||8.06|0.29|
72344091|NCT01393639|144210806|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.64|||||TWO_SIDED|95.0|-7.21|-0.06||||||Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.06|-7.21|
72344092|NCT01393639|144210806|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.7|||||TWO_SIDED|95.0|-6.25|0.85||||||Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.85|-6.25|
72344093|NCT01393639|144210806|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.01|||||TWO_SIDED|95.0|-5.63|1.6||||||Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||1.60|-5.63|
72344094|NCT01393639|144210806|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.49|||||TWO_SIDED|95.0|-5.02|2.05||||||Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||2.05|-5.02|
72344095|NCT01393639|144210806|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.19|||||TWO_SIDED|95.0|-10.07|-2.31||||||Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-2.31|-10.07|
72344096|NCT01393639|144210806|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.69|||||TWO_SIDED|95.0|-6.6|1.23||||||Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||1.23|-6.60|
72344097|NCT01393639|144210806|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.73|||||TWO_SIDED|95.0|-6.64|1.18||||||Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||1.18|-6.64|
72344098|NCT01393639|144210806|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.29|||||TWO_SIDED|95.0|-6.16|1.58||||||Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||1.58|-6.16|
72344099|NCT01393639|144210808|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.73|||||TWO_SIDED|95.0|-0.83|4.3||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||4.30|-0.83|
72344100|NCT01393639|144210808|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.9|||||TWO_SIDED|95.0|0.35|5.45||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||5.45|0.35|
72344101|NCT01393639|144210808|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|6.12|||||TWO_SIDED|95.0|3.54|8.7||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||8.70|3.54|
72344102|NCT01393639|144210808|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.73|||||TWO_SIDED|95.0|2.19|7.26||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||7.26|2.19|
72344103|NCT01393639|144210808|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.18|||||TWO_SIDED|95.0|-0.39|4.76||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||4.76|-0.39|
72344104|NCT01393639|144210808|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.41|||||TWO_SIDED|95.0|2.83|7.99||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||7.99|2.83|
72344105|NCT01393639|144210808|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.79|||||TWO_SIDED|95.0|-1.08|4.65||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||4.65|-1.08|
72344106|NCT01393639|144210808|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.4|||||TWO_SIDED|95.0|1.52|7.28||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||7.28|1.52|
72344107|NCT01393639|144210808|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|6.2|||||TWO_SIDED|95.0|3.33|9.07||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||9.07|3.33|
72344108|NCT01393639|144210808|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.7|||||TWO_SIDED|95.0|0.85|6.55||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||6.55|0.85|
72344109|NCT01393639|144210808|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.61|||||TWO_SIDED|95.0|0.74|6.47||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||6.47|0.74|
72344110|NCT01393639|144210808|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|6.17|||||TWO_SIDED|95.0|3.29|9.04||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||9.04|3.29|
72344111|NCT01393639|144210808|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.68|||||TWO_SIDED|95.0|-6.27|-1.09||||||Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-1.09|-6.27|
72344112|NCT01393639|144210808|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.51|||||TWO_SIDED|95.0|-5.07|0.05||||||Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.05|-5.07|
72344113|NCT01393639|144210808|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.71|||||TWO_SIDED|95.0|-1.88|3.3||||||Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||3.30|-1.88|
72344114|NCT01393639|144210808|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.68|||||TWO_SIDED|95.0|-3.23|1.87||||||Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||1.87|-3.23|
72344115|NCT01393639|144210808|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.38|||||TWO_SIDED|95.0|-7.26|-1.5||||||Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-1.50|-7.26|
72344116|NCT01393639|144210808|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.76|||||TWO_SIDED|95.0|-4.65|1.12||||||Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||1.12|-4.65|
72344117|NCT01393639|144210808|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.03|||||TWO_SIDED|95.0|-2.84|2.91||||||Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||2.91|-2.84|
72344118|NCT01393639|144210808|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.47|||||TWO_SIDED|95.0|-5.33|0.39||||||Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.39|-5.33|
72344119|NCT00793325|144210825|SUPERIORITY_OR_OTHER||||||=|0.575|TWO_SIDED||||||Chi-squared|||"The risk factor tested was Age. The null hypothesis is that there is no difference between \<15 years and \>=15 years in the frequency of treatment related adverse events."||||=0.575
72344120|NCT00793325|144210826|SUPERIORITY_OR_OTHER||||||=|0.206|TWO_SIDED||||||Chi-squared|||"The risk factor tested was Gender. The null hypothesis is that there is no difference between Male and Female in the frequency of treatment related adverse events."||||=0.206
72344121|NCT00793325|144210827|SUPERIORITY_OR_OTHER||||||=|0.033|TWO_SIDED||||||Chi-squared|||"The risk factor tested was Severity. The null hypothesis is that there is no association between mild, moderate and severe in the frequency of treatment related adverse events."||||=0.033
72344122|NCT00793325|144210827|SUPERIORITY_OR_OTHER||||||=|0.207|TWO_SIDED||||||Cochran-Armitage Exact|||"The risk factor tested was Severity. The null hypothesis is that there is no linear trend in the frequency of treatment related adverse events across increasing levels of severity."||||=0.207
72344123|NCT00793325|144210828|SUPERIORITY_OR_OTHER||||||=|0.013|TWO_SIDED||||||Chi-squared|||"The risk factor tested was Past history of any disease. The null hypothesis is that there is no difference between With past history of any disease and Without past history any disease in the frequency of treatment related adverse events."||||=0.013
72344124|NCT00793325|144210829|SUPERIORITY_OR_OTHER||||||=|0.009|TWO_SIDED||||||Chi-squared|||"The risk factor tested was Complication(s). The null hypothesis is that there is no difference between With complication(s) and Without complication(s)in the frequency of treatment related adverse events."||||=0.009
72344125|NCT00793325|144210830|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Chi-squared|||"The risk factor tested was Hepatic Function Disorder. The null hypothesis is that there is no difference between with Hepatic Function Disorder and without Hepatic Function Disorder in the frequency of treatment related adverse events."||||<0.001
72344126|NCT00793325|144210831|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Chi-squared|||"The risk factor tested was Renal Impairment. The null hypothesis is that there is no difference between With Renal Impairment and Without Renal Impairment in the frequency of treatment related adverse events."||||<0.001
72344127|NCT00793325|144210832|SUPERIORITY_OR_OTHER||||||=|0.003|TWO_SIDED||||||Chi-squared|||"The risk factor tested was Concomitant Drug(s). The null hypothesis is that there is no difference between With Concomitant Drug(s) and Without Concomitant Drug(s) in the frequency of treatment related adverse events."||||=0.003
72344128|NCT00793325|144210833|SUPERIORITY_OR_OTHER||||||<|0.001|ONE_SIDED||||||t-test, 1 sided|A one-sided paired t-test was performed to test the hypothesis.||The null hypothesis is that there is no difference in the mean value of the change in the growth rate SD score for calendar age between SGA at one year and SGA at baseline.||||<0.001
72344129|NCT00793325|144210833|SUPERIORITY_OR_OTHER||||||<|0.001|ONE_SIDED||||||t-test, 1 sided|A one-sided paired t-test was performed to test the null hypothesis.||The null hypothesis is that there is no difference in the mean value of the change in the growth rate SD score for calendar age between SGA at two years and SGA at baseline.||||<0.001
72344130|NCT00793325|144210833|SUPERIORITY_OR_OTHER||||||<|0.001|ONE_SIDED||||||t-test, 1 sided|A one-sided paired t-test was performed to test the null hypothesis.||The null hypothesis is that there is no difference in the mean value of the change in the growth rate SD score for calendar age between SGA at three years and SGA at baseline.||||<0.001
72344131|NCT00793325|144210834|SUPERIORITY_OR_OTHER||||||<|0.001|ONE_SIDED||||||t-test, 1 sided|A one-sided paired t-test was performed to test the null hypothesis.||The null hypothesis is that there is no difference in the mean value of the change in the height SD score for calendar age between SGA at one year and SGA at baseline.||||<0.001
72344132|NCT00793325|144210834|SUPERIORITY_OR_OTHER||||||<|0.001|ONE_SIDED||||||t-test, 1 sided|A one-sided paired t-test was performed to test the null hypothesis.||The null hypothesis is that there is no difference in the mean value of the change in the height SD score for calendar age between SGA at two years and SGA at baseline.||||<0.001
72344133|NCT00793325|144210834|SUPERIORITY_OR_OTHER||||||<|0.001|ONE_SIDED||||||t-test, 1 sided|A one-sided paired t-test was performed to test the hypothesis.||The null hypothesis is that there is no difference in the mean value of the change in the height SD score for calendar age between SGA at three years and SGA at baseline.||||<0.001
72344134|NCT01815840|144210835|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.3|||||TWO_SIDED|95.0|-22.2|5.7|||||Asymptotic confidence intervals are presented for the difference between treatment arms.|The mean difference in the mean relative reduction between treatment arms, along with the corresponding 95% confidence interval, was estimated by fitting an ANCOVA model with treatment as main effect and the following covariates: number of basal cell carcinomas at baseline, geographical region, immunosuppression status, confirmed basal cell carcinoma nevus syndrome.||5.7|-22.2|
72344135|NCT00434642|144210847|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.484|||<|0.0001|TWO_SIDED|95.0|0.388|0.605||A P-value \< 0.05 was required for significance.|Log Rank|The analysis was stratified for time since the last platinum therapy (6-12, \> 12 months) and cytoreductive surgery for recurrent disease (yes, no).|The hazard ratio was estimated using Cox regression. The hazard ratio is relative to the carboplatin and gemcitabine + placebo group.|The null hypothesis was that there was no difference between the 2 treatment groups, ie, that the hazard ratio is equal to 1. The alternative hypothesis was that progression free survival was longer in the carboplatin and gemcitabine + bevacizumab group, ie, that the hazard ratio is not equal to 1.||0.605|0.388|<0.0001
72344136|NCT00434642|144210848|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|21.1|||<|0.0001|TWO_SIDED|95.0|13.0|29.2||A P-value \< 0.05 was required for significance.|Cochran-Mantel-Haenszel|The analysis was stratified for time since the last platinum therapy (6-12, \> 12 months) and cytoreductive surgery for recurrent disease (yes, no).|The difference in response rates and the 95% confidence intervals for response rates were computed using the normal approximation to the binomial distribution.|The null hypothesis was that there was no difference in the percentage of patients with an objective response between the 2 treatment groups. The alternative hypothesis was that a larger percentage of patients had an objective response in the carboplatin and gemcitabine + bevacizumab group.||29.2|13.0|<0.0001
72344137|NCT00434642|144210850|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.952||||0.6479|TWO_SIDED|95.0|0.771|1.176||Summaries of duration of overall survival (median, percentiles) were estimated from Kaplan-Meier curves. The 95% confidence interval for the median was computed using the method of Brookmeyer and Crowley.|Log Rank|The analysis was stratified for time since the last platinum therapy (≤12, \>12 months) and cytoreductive surgery for recurrent disease (Yes, No).|The hazard ratio was estimated using Cox regression. The hazard ratio is relative to the carboplatin and gemcitabine + placebo group.|||1.176|0.771|0.6479
72344138|NCT04473664|144210878|OTHER|Least squares (LS) means were calculated from an analysis of variance (ANOVA) model on log-transformed scale. The LS means for each treatment were back transformed from the log scale to provide estimates of the geometric means (GMS). The ratio (%) of GMS was calculated and 90% Confidence Intervals (CIs) for the ratio (%) of GMS were presented.|Ratio (%) of Geometric LS Mean]|95.1|||||TWO_SIDED|90.0|77.1|117.0|||||For the comparison, the Moderate Hepatic Impairment treatment group represents the numerator and Normal Hepatic Function treatment group represents the denominator.|Statistical comparison was analyzed for Quizartinib.||117|77.1|
72370147|NCT02283762|144250649|SUPERIORITY|The pre-specified test was for superiority but ONLY if the primary endpoint and secondary endpoints were meeting statistical significance (hierarchical testing).|Difference in LS means|-0.2||||0.901|TWO_SIDED|95.0|-3.4|3.0|||MMRM (Method 1)|||change from baseline||3.00|-3.40|0.9010
72370148|NCT00202878|144250657|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.936||||0.016|TWO_SIDED|95.0|0.887|0.988|||Cox proportional hazard model|Covariates of the stratification factors (EARLY ACS trial, chronic prescription lipid-lowering experience, and high-risk ACS diagnosis) and treatment.|Model includes events from randomization to last study visit.|||0.988|0.887|0.016
72370149|NCT00202878|144250658|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.948||||0.035|TWO_SIDED|95.0|0.903|0.996|||Cox proportional hazard model|Covariates of the stratification factors (EARLY ACS trial, chronic prescription lipid-lowering experience, and high-risk ACS diagnosis) and treatment.|Model includes events from randomization to last study visit.|||0.996|0.903|0.035
72344139|NCT04473664|144210880|OTHER|Least squares (LS) means were calculated from an analysis of variance (ANOVA) model on log-transformed scale. The LS means for each treatment were back transformed from the log scale to provide estimates of the geometric means (GMS). The ratio (%) of GMS was calculated and 90% Confidence Intervals (CIs) for the ratio (%) of GMS were presented.|Ratio (%) of Geometric LS Mean]|109.0|||||TWO_SIDED|90.0|59.5|201.0|||||For the comparison, the Moderate Hepatic Impairment treatment group represents the numerator and Normal Hepatic Function treatment group represents the denominator.|AUClast statistical comparison was analyzed for Quizartinib.||201|59.5|
72344140|NCT04473664|144210880|OTHER|Least squares (LS) means were calculated from an analysis of variance (ANOVA) model on log-transformed scale. The LS means for each treatment were back transformed from the log scale to provide estimates of the geometric means (GMS). The ratio (%) of GMS was calculated and 90% Confidence Intervals (CIs) for the ratio (%) of GMS were presented.|Ratio (%) of Geometric LS Mean]|109.0|||||TWO_SIDED|90.0|57.9|207.0|||||For the comparison, the Moderate Hepatic Impairment treatment group represents the numerator and Normal Hepatic Function treatment group represents the denominator.|AUCinf statistical comparison was analyzed for Quizartinib.||207|57.9|
72344141|NCT04473664|144210884|OTHER|Least squares (LS) means were calculated from an analysis of variance (ANOVA) model on log-transformed scale. The LS means for each treatment were back transformed from the log scale to provide estimates of the geometric means (GMS). The ratio (%) of GMS was calculated and 90% Confidence Intervals (CIs) for the ratio (%) of GMS were presented.|Ratio (%) of Geometric LS Mean|74.4|||||TWO_SIDED|90.0|32.0|173.0|||||For the comparison, the Moderate Hepatic Impairment treatment group represents the numerator and Normal Hepatic Function treatment group represents the denominator.|Statistical comparison was analyzed for AC886.||173|32.0|
72344142|NCT04473664|144210886|OTHER|Least squares (LS) means were calculated from an analysis of variance (ANOVA) model on log-transformed scale. The LS means for each treatment were back transformed from the log scale to provide estimates of the geometric means (GMS). The ratio (%) of GMS was calculated and 90% Confidence Intervals (CIs) for the ratio (%) of GMS were presented.|Ratio (%) of Geometric LS Mean|62.5|||||TWO_SIDED|90.0|35.3|111.0|||||For the comparison, the Moderate Hepatic Impairment treatment group represents the numerator and Normal Hepatic Function treatment group represents the denominator.|AUClast statistical comparison was analyzed for AC886.||111|35.3|
72344143|NCT04473664|144210886|OTHER|Least squares (LS) means were calculated from an analysis of variance (ANOVA) model on log-transformed scale. The LS means for each treatment were back transformed from the log scale to provide estimates of the geometric means (GMS). The ratio (%) of GMS was calculated and 90% Confidence Intervals (CIs) for the ratio (%) of GMS were presented.|Ratio (%) of Geometric LS Mean|69.9|||||TWO_SIDED|90.0|46.8|104.0|||||For the comparison, the Moderate Hepatic Impairment treatment group represents the numerator and Normal Hepatic Function treatment group represents the denominator.|AUCinf statistical comparison was analyzed for AC886.||104|46.8|
72344144|NCT04473664|144210889|OTHER|Least squares (LS) means were calculated from an analysis of variance (ANOVA) model on log-transformed scale. The LS means for each treatment were back transformed from the log scale to provide estimates of the geometric means (GMS). The ratio (%) of GMS was calculated and 90% Confidence Intervals (CIs) for the ratio (%) of GMS were presented.|Ratio (%) of Geometric LS Mean|44.7|||||TWO_SIDED|90.0|18.0|111.0|||||For the comparison, the Moderate Hepatic Impairment treatment group represents the numerator and Normal Hepatic Function treatment group represents the denominator.|Statistical comparison was analyzed for Quizartinib.||111|18.0|
72344145|NCT04473664|144210890|OTHER|Least squares (LS) means were calculated from an analysis of variance (ANOVA) model on log-transformed scale. The LS means for each treatment were back transformed from the log scale to provide estimates of the geometric means (GMS). The ratio (%) of GMS was calculated and 90% Confidence Intervals (CIs) for the ratio (%) of GMS were presented.|Ratio (%) of Geometric LS Mean|51.5|||||TWO_SIDED|90.0|16.0|165.0|||||For the comparison, the Moderate Hepatic Impairment treatment group represents the numerator and Normal Hepatic Function treatment group represents the denominator.|AUClast statistical comparison was analyzed for Quizartinib.||165|16.0|
72344146|NCT04473664|144210890|OTHER|Least squares (LS) means were calculated from an analysis of variance (ANOVA) model on log-transformed scale. The LS means for each treatment were back transformed from the log scale to provide estimates of the geometric means (GMS). The ratio (%) of GMS was calculated and 90% Confidence Intervals (CIs) for the ratio (%) of GMS were presented.|Ratio (%) of Geometric LS Mean|51.5|||||TWO_SIDED|90.0|15.8|168.0|||||For the comparison, the Moderate Hepatic Impairment treatment group represents the numerator and Normal Hepatic Function treatment group represents the denominator.|AUCinf statistical comparison was analyzed for Quizartinib.||168|15.8|
72344147|NCT00789672|144210901|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.0|STANDARD_DEVIATION|4.7|||TWO_SIDED|95.0|-6.0|1.0||||||Given this was pilot study, no formal sample size estimates were calculated.||1|-6|
72344148|NCT03392649|144210907|SUPERIORITY|||||||0.6|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||0.60
72344149|NCT03392649|144210908|SUPERIORITY|||||||0.34|||||||Chi-squared|||||||0.34
72344150|NCT03392649|144210909|SUPERIORITY|||||||0.54|||||||Wilcoxon (Mann-Whitney)|||||||0.54
72344151|NCT03392649|144210910|SUPERIORITY|||||||0.09|||||||Fisher Exact|||||||0.09
72344152|NCT03392649|144210911|SUPERIORITY|||||||0.16|||||||Fisher Exact|||||||0.16
72344153|NCT03392649|144210912|SUPERIORITY|||||||0.67|||||||Fisher Exact|||||||0.67
72344154|NCT03392649|144210913|SUPERIORITY|||||||1|||||||Chi-squared|||||||1.0
72344155|NCT03392649|144210914|SUPERIORITY|||||||0.12|||||||Fisher Exact|||||||0.12
72344156|NCT03927144|144210957|SUPERIORITY||Odds Ratio (OR)|6.48|||<|0.0001|TWO_SIDED|95.0|4.28|9.82|||Cochran-Mantel-Haenszel|Adjusted for stratification factor (no. of prior prophylactic migraine treatment failures=1 vs 2) after missing data were imputed as non-response.||||9.82|4.28|<0.0001
72344157|NCT03927144|144210958|SUPERIORITY||Odds Ratio (OR)|11.27|||<|0.0001|TWO_SIDED|95.0|7.53|16.87|||Cochran-Mantel-Haenszel|Adjusted for number of prior prophylactic migraine treatment failures=1 vs 2 after missing data were imputed as non-response.||||16.87|7.53|<0.0001
72344158|NCT03927144|144210959|SUPERIORITY||Treatment difference|-2.13|STANDARD_ERROR_OF_MEAN|0.31|<|0.001|TWO_SIDED|95.0|-2.74|-1.52|||Linear mixed effects model||AMG334 70 mg/140 mg vs Oral Prophylactic|Comparison of mean change from baseline in monthly migraine days at Week 52||-1.52|-2.74|<0.001
72344159|NCT03927144|144210960|SUPERIORITY||Odds Ratio (OR)|13.75|||<|0.001|TWO_SIDED|95.0|9.08|20.83|||Cochran-Mantel-Haenszel|Adjusted for number of prior prophylactic migraine treatment failures=1 vs 2 after missing data were imputed as non-response.||||20.83|9.08|<0.001
72344160|NCT01463072|144210971|OTHER||Percent|35.0|||||TWO_SIDED|95.0|21.0|52.0|||||35% of participants were responders (CR+PR).|||52|21|
72344161|NCT01463072|144210973|SUPERIORITY||Odds Ratio (OR)|5.8||||0.01|TWO_SIDED|95.0|1.3|33.1|||Fisher Exact||Ratio is intermediate/high toxicity risk over low toxicity risk|CARG chemotherapy toxicity risk predictive of chemotherapy toxicity (grade 3)||33.1|1.3|0.01
72344162|NCT01463072|144210973|SUPERIORITY||Ratio of group means|1.38||||0.02|TWO_SIDED|95.0|1.04|1.8|||t-test, 2 sided||Ratio is dose reduction over no dose reduction.|CARG chemotherapy toxicity risk predictive of dose reduction due to chemotherapy toxicity||1.80|1.04|0.02
72344163|NCT01192412|144210994|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.02|||||TWO_SIDED|95.0|0.77|1.35||||||We estimated that with a sample size of 514 per group, the study would have 80% power, at a two-tailed alpha level of 0.05, assuming primary outcome rates of 33% in the tight-control group and 25% in the less-tight-control group, a 10% rate of crossover, a 1% loss to follow-up, and two interim analyses, as calculated with the chi-square test with the use of East software (Cytel) and the Lan-DeMets spending function with O'Brien-Fleming-type boundaries for early stopping.||1.35|0.77|
72344164|NCT01192412|144210995|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.74|||||TWO_SIDED|95.0|0.79|3.84||||||||3.84|0.79|
72344165|NCT04071158|144211010|SUPERIORITY||Difference in proportions|0.0|||||TWO_SIDED|95.0|-1.4|2.8||||||Difference in percentage||2.8|-1.4|
72344166|NCT04071158|144211011|SUPERIORITY||Difference in proportions|-1.8|||||TWO_SIDED|95.0|-4.6|1.7||||||Difference in percentage||1.7|-4.6|
72428708|NCT04147260|144368580|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|0.15|STANDARD_ERROR_OF_MEAN|0.077||0.057|TWO_SIDED|90.0|0.0|0.31||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||0.31|0.00|0.057
72344167|NCT04071158|144211012|SUPERIORITY||Ratio of Geometric Mean|0.8|||||TWO_SIDED|95.0|0.64|1.0||||||Anti-PT: Ratio of geometric mean was calculated by dividing the GMC of RSV vaccine with aluminum hydroxide with Tdap arm by GMC of placebo/Tdap arm.||1.00|0.64|
72344168|NCT04071158|144211012|SUPERIORITY||Ratio of Geometric Mean|0.59|||||TWO_SIDED|95.0|0.5|0.7||||||Anti-PT: Ratio of geometric mean was calculated by dividing the GMC of RSV vaccine with aluminum hydroxide with Tdap arm by GMC of placebo/Tdap arm.||0.70|0.50|
72344169|NCT04071158|144211012|SUPERIORITY||Ratio of Geometric Mean|0.6|||||TWO_SIDED|95.0|0.48|0.76||||||Anti-PT: Ratio of geometric mean was calculated by dividing the GMC of RSV vaccine with aluminum hydroxide with Tdap arm by GMC of placebo/Tdap arm.||0.76|0.48|
72344170|NCT04071158|144211013|SUPERIORITY||Ratio of Geometric Mean|0.97|||||TWO_SIDED|95.0|0.84|1.13|||||Ratio of geometric mean was calculated by dividing GMT of RSV vaccine with aluminum hydroxide with Tdap arm by GMT of RSV vaccine with aluminum hydroxide with placebo arm.|2.0-fold margin (related to primary objective): primary objective was demonstrated if the lower limit of 95% confidence interval (CI) from the ratio of titers with 50 percent cut off from two treatment groups greater than (\>) 0.5.||1.13|0.84|
72344171|NCT04071158|144211014|SUPERIORITY||Ratio of Geometric Mean|0.96|||||TWO_SIDED|95.0|0.81|1.14|||||Ratio of geometric mean was calculated by dividing GMT of RSV vaccine with aluminum hydroxide with Tdap arm by GMT of RSV vaccine with aluminum hydroxide with placebo arm.|2.0-fold margin (related to primary objective): primary objective was demonstrated if the lower limit of 95% CI from the ratio of titers with 50 percent cut off from two treatment groups \> 0.5.||1.14|0.81|
72344172|NCT04071158|144211019|SUPERIORITY||Ratio of Geometric Mean|0.97|||||TWO_SIDED|95.0|0.84|1.13|||||Ratio of geometric mean was calculated by dividing GMT of RSV vaccine with aluminum hydroxide with Tdap arm by GMT of RSV vaccine with aluminum hydroxide with placebo arm.|1.5-fold margin (related to secondary objective): secondary objective was demonstrated if the lower limit of 95% CI from the ratio of titers with 50 percent cut off from two treatment groups \> 0.67.||1.13|0.84|
72344173|NCT04071158|144211020|SUPERIORITY||Ratio of Geometric Mean|0.96|||||TWO_SIDED|95.0|0.81|1.14|||||Ratio of geometric mean was calculated by dividing GMT of RSV vaccine with aluminum hydroxide with Tdap arm by GMT of RSV vaccine with aluminum hydroxide with placebo arm.|1.5-fold margin (related to secondary objective): secondary objective was demonstrated if the lower limit of 95% CI from the ratio of titers with 50 percent cut off from two treatment groups \> 0.67.||1.14|0.81|
72344174|NCT01178099|144211025|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Means, SCD:Healthy|1.05|||||TWO_SIDED|90.0|0.829|1.33|||Mixed Models Analysis|Log(AUC) = Participant + Population + Dose + Population\*Dose + Random Error|This is the estimated value for the 10 mg SD (overall).|||1.33|0.829|
72344175|NCT01178099|144211025|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Means, SCD:Healthy|0.895|||||TWO_SIDED|90.0|0.718|1.12|||Mixed Models Analysis|Log(AUC) = Participant + Population + Dose + Population\*Dose + Random Error|This is the estimated value for the 7.5 mg MD.|||1.12|0.718|
72344176|NCT01178099|144211025|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Means, SCD:Healthy|0.905|||||TWO_SIDED|90.0|0.656|1.25|||Mixed Models Analysis|Log(AUC) = Participant + Population + Dose + Population\*Dose + Random Error|This is the estimated value for the 5 mg MD.|||1.25|0.656|
72344177|NCT01178099|144211026|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Means, SCD:Healthy|0.953|||||TWO_SIDED|90.0|0.664|1.37|||Mixed Models Analysis|Log(Cmax) = Participant + Population + Dose + Population\*Dose + Random Error|This is the estimated value for the 10 mg SD (overall).|||1.37|0.664|
72344178|NCT01178099|144211026|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Means, SCD:Healthy|0.612|||||TWO_SIDED|90.0|0.436|0.86|||Mixed Models Analysis|Log(Cmax) = Participant + Population + Dose + Population\*Dose + Random Error|This is the estimated value for the 7.5 mg MD.|||0.860|0.436|
72344179|NCT01178099|144211026|SUPERIORITY_OR_OTHER||Geometric LS Means, SCD:Healthy|1.03|||||TWO_SIDED|90.0|0.625|1.68|||Mixed Models Analysis|Log(Cmax) = Participant + Population + Dose + Population\*Dose + Random Error|This is the estimated value for 5 mg MD.|||1.68|0.625|
72344180|NCT01178099|144211027|SUPERIORITY_OR_OTHER|||||||0.07||95.0||||The p-value is from model: Change from Baseline = Baseline + Treatment + Population + Treatment\*Population + Random Error.|ANCOVA|||||||0.070
72344181|NCT01178099|144211028|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Means, SCD:Healthy|1.52|||||TWO_SIDED|90.0|1.1|2.1|||Mixed Models Analysis|Log(AUC) = Participant + Population + Dose + Population\*Dose + Random Error|This is the estimated value for 10 mg SD (overall) for the R-95913 metabolite.|||2.10|1.10|
72344182|NCT01178099|144211028|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Means, SCD:Healthy|1.44|||||TWO_SIDED|90.0|1.06|1.94|||Mixed Models Analysis|Log(AUC) = Participant + Population + Dose + Population\*Dose + Random Error|This is the estimated value for 7.5 mg MD for the R-95913 metabolite.|||1.94|1.06|
72344183|NCT01178099|144211028|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Means, SCD:Healthy|1.43|||||TWO_SIDED|90.0|0.918|2.21|||Mixed Models Analysis|Log(AUC) = Participant + Population + Dose + Population\*Dose + Random Error|This is the estimated value for 5 mg MD for the R-95913 metabolite.|||2.21|0.918|
72344184|NCT01178099|144211028|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Means, SCD:Healthy|0.971|||||TWO_SIDED|90.0|0.742|1.27|||Mixed Models Analysis|Log(AUC) = Participant + Population + Dose + Population\*Dose + Random Error|This is the estimated value for the 10 mg SD (overall) for the R-106583 metabolite.|||1.27|0.742|
72344185|NCT01178099|144211028|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Means, SCD:Healthy|0.815|||||TWO_SIDED|90.0|0.633|1.05|||Mixed Models Analysis|Log(AUC) = Participant + Population + Dose + Population\*Dose + Random Error|This is the estimated value for the 7.5 mg MD for the R-106583 metabolite.|||1.05|0.633|
72344186|NCT01178099|144211028|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Means, SCD:Healthy|0.952|||||TWO_SIDED|90.0|0.658|1.38|||Mixed Models Analysis|Log(AUC) = Participant + Population + Dose + Population\*Dose + Random Error|This is the estimated value for the 5 mg MD for the R-106583 metabolite.|||1.38|0.658|
72344187|NCT01178099|144211028|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Means, SCD:Healthy|1.17|||||TWO_SIDED|90.0|0.833|1.65|||Mixed Models Analysis|Log(AUC) = Participant + Population + Dose + Population\*Dose + Random Error|This is the estimated value for 10 mg SD (overall) for the R-119251 metabolite.|||1.65|0.833|
72344188|NCT01178099|144211028|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Means, SCD:Healthy|1.07|||||TWO_SIDED|90.0|0.779|1.48|||Mixed Models Analysis|Log(AUC) = Participant + Population + Dose + Population\*Dose + Random Error|This is the estimated value for 7.5 mg MD for the R-119251 metabolite.|||1.48|0.779|
72344189|NCT01178099|144211028|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Means, SCD:Healthy|0.813|||||TWO_SIDED|95.0|0.51|1.3|||Mixed Models Analysis|Log(AUC) = Participant + Population + Dose + Population\*Dose + Random Error|This is the estimated value for 5 mg MD for the R-119251 metabolite.|||1.30|0.510|
72428709|NCT04147260|144368581|EQUIVALENCE|Two-sided 90% CI with an acceptance range of -0.4 to 0.4|Mean Difference (Final Values)|0.23|STANDARD_ERROR_OF_MEAN|0.153|||TWO_SIDED|90.0|-0.02|0.49|||Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values||0.49|-0.02|
72344190|NCT01178099|144211029|SUPERIORITY_OR_OTHER|||||||0.018||95.0||||The p-value is from model: Change from Baseline = Baseline + Treatment + Population + Treatment\*Population + Random Error.|ANCOVA|||||||0.018
72344191|NCT01178099|144211030|SUPERIORITY_OR_OTHER|||||||0.06||95.0||||The p-value is from model: Change from Baseline = Baseline + Treatment + Population + Treatment\*Population + Random Error.|ANCOVA|||||||0.060
72344192|NCT01178099|144211031|SUPERIORITY_OR_OTHER|||||||0.219||95.0||||The p-value is from model: Change from Baseline = Baseline + Treatment + Population + Treatment\*Population + Random Error.|ANCOVA|||||||0.219
72344193|NCT01178099|144211032|SUPERIORITY_OR_OTHER|||||||0.177||95.0||||The p-value is from model: Change from Baseline = Baseline + Treatment + Population + Treatment\*Population + Random Error.|ANCOVA|||||||0.177
72344194|NCT01178099|144211033|SUPERIORITY_OR_OTHER|||||||0.168||95.0||||The p-value is from model: Change from Baseline = Baseline + Treatment + Population + Treatment\*Population + Random Error.|ANCOVA|||||||0.168
72344195|NCT01178099|144211034|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Means, SCD:Healthy|1.5|||||TWO_SIDED|90.0|1.01|2.22|||Mixed Models Analysis|Log(Cmax) = Participant + Population + Dose + Population\*Dose + Random Error|This is the estimated value for 10 mg SD (overall) for the R-95913 metabolite.|||2.22|1.01|
72344196|NCT01178099|144211034|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Means, SCD:Healthy|1.09|||||TWO_SIDED|90.0|0.751|1.58|||Mixed Models Analysis|Log(Cmax) = Participant + Population + Dose + Population\*Dose + Random Error|This is the estimated value for 7.5 mg MD for the R-95913 metabolite.|||1.58|0.751|
72344197|NCT01178099|144211034|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Means, SCD:Healthy|1.87|||||TWO_SIDED|90.0|1.09|3.2|||Mixed Models Analysis|Log(Cmax) = Participant + Population + Dose + Population\*Dose + Random Error|This is the estimated value for 5 mg MD for the R-95913 metabolite.|||3.20|1.09|
72344198|NCT01178099|144211034|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Means, SCD:Healthy|0.873|||||TWO_SIDED|90.0|0.66|1.15|||Mixed Models Analysis|Log(Cmax) = Participant + Population + Dose + Population\*Dose + Random Error|This is the estimated value for 10 mg SD (overall) for the R-106583 metabolite.|||1.15|0.660|
72344199|NCT01178099|144211034|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Means, SCD:Healthy|0.681|||||TWO_SIDED|90.0|0.524|0.886|||Mixed Models Analysis|Log(Cmax) = Participant + Population + Dose + Population\*Dose + Random Error|This is the estimated value for 7.5 mg MD for the R-106583 metabolite.|||0.886|0.524|
72344200|NCT01178099|144211034|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Means, SCD:Healthy|0.898|||||TWO_SIDED|90.0|0.612|1.32|||Mixed Models Analysis|Log(Cmax) = Participant + Population + Dose + Population\*Dose + Random Error|This is the estimated value for 5 mg MD for the R-106583 metabolite.|||1.32|0.612|
72344201|NCT01178099|144211034|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Means, SCD:Healthy|1.06|||||TWO_SIDED|90.0|0.773|1.46|||Mixed Models Analysis|Log(Cmax) = Participant + Population + Dose + Population\*Dose + Random Error|This is the estimated value for 10 mg SD (overall) for the R-119251 metabolite.|||1.46|0.773|
72344202|NCT01178099|144211034|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Means, SCD:Healthy|0.785|||||TWO_SIDED|90.0|0.582|1.06|||Mixed Models Analysis|Log(Cmax) = Participant + Population + Dose + Population\*Dose + Random Error|This is the estimated value for 7.5 mg MD for the R-119251 metabolite.|||1.06|0.582|
72344203|NCT01178099|144211034|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Means, SCD:Healthy|1.0|||||TWO_SIDED|90.0|0.648|1.55|||Mixed Models Analysis|Log(Cmax) = Participant + Population + Dose + Population\*Dose + Random Error|This is the estimated value for 5 mg MD for the R-119251 metabolite.|||1.55|0.648|
72344204|NCT01178099|144211035|SUPERIORITY_OR_OTHER|||||||0.06||95.0||||The p-value is from model: Change from Baseline = Baseline + Treatment + Population + Treatment\*Population + Random Error.|ANCOVA|||||||0.060
72344205|NCT01178099|144211036|SUPERIORITY_OR_OTHER|||||||0.086||95.0||||This is the p-value for PRI by flow cytometry. The p-value is from model: Change from Baseline = Baseline + Treatment + Population + Treatment\*Population + Random Error|ANCOVA|||||||0.086
72344206|NCT01178099|144211036|SUPERIORITY_OR_OTHER|||||||0.679||95.0||||This is the p-value for PRI by ELISA. The p-value is from model: Change from Baseline = Baseline + Treatment + Population + Treatment\*Population + Random Error|ANCOVA|||||||0.679
72344207|NCT01178099|144211037|SUPERIORITY_OR_OTHER|||||||0.396||95.0||||This is the p-value for AU\*min to 6.5 µM ADP. The p-value is from model: Change from Baseline = Baseline + Treatment + Population + Treatment\*Population + Random Error.|ANCOVA|||||||0.396
72344208|NCT01178099|144211037|SUPERIORITY_OR_OTHER|||||||0.288||95.0||||This is the p-value for AU\*min to 20 µM ADP. The p-value is from model: Change from Baseline = Baseline + Treatment + Population + Treatment\*Population + Random Error.|ANCOVA|||||||0.288
72344209|NCT01178099|144211037|SUPERIORITY_OR_OTHER|||||||0.095||95.0||||This is the p-value for AU\*min to Collagen. The p-value is from model: Change from Baseline = Baseline + Treatment + Population + Treatment\*Population + Random Error.|ANCOVA|||||||0.095
72344210|NCT01178099|144211037|SUPERIORITY_OR_OTHER|||||||0.086||95.0||||This is the p-value for AU\*min to TRAP-6. The p-value is from model: Change from Baseline = Baseline + Treatment + Population + Treatment\*Population + Random Error.|ANCOVA|||||||0.086
72344211|NCT01178099|144211038|SUPERIORITY_OR_OTHER|||||||0.083||95.0||||The p-value is from model: Change from Baseline = Baseline + Treatment + Population + Treatment\*Population + Random Error.|ANCOVA|||||||0.083
72344212|NCT01178099|144211039|SUPERIORITY_OR_OTHER|||||||0.124||95.0||||The p-value is from model: Change from Baseline = Baseline + Treatment + Population + Treatment\*Population + Random Error.|ANCOVA|||||||0.124
72428710|NCT04147260|144368581|EQUIVALENCE|Two-sided 90% CI with an acceptance range of -0.4 to 0.4|Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.124|||TWO_SIDED|90.0|-0.2|0.22|||Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values||0.22|-0.20|
72428711|NCT04147260|144368581|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|-0.51|STANDARD_ERROR_OF_MEAN|0.102|<|0.001|TWO_SIDED|90.0|-0.72|-0.31||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||-0.31|-0.72|<0.001
72428712|NCT04147260|144368581|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|0.52|STANDARD_ERROR_OF_MEAN|0.138|<|0.001|TWO_SIDED|90.0|0.24|0.8||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||0.80|0.24|<0.001
72344213|NCT02516592|144211040|SUPERIORITY||Mean Difference (Final Values)|0.045||||0.028|TWO_SIDED|95.0|0.005|0.084|||Mixed Models Analysis|||||0.084|0.005|0.028
72344214|NCT02516592|144211041|SUPERIORITY||Mean Difference (Final Values)|0.46||||0.063|TWO_SIDED|95.0|-0.03|0.94|||Mixed Models Analysis|||||0.94|-0.03|0.063
72344215|NCT02516592|144211042|SUPERIORITY||Mean Difference (Final Values)|0.102||||0.002|TWO_SIDED|95.0|0.037|0.167|||Mixed Models Analysis|||||0.167|0.037|0.002
72344216|NCT02516592|144211043|SUPERIORITY||Mean Difference (Final Values)|-0.4||||0.319|TWO_SIDED|95.0|-1.3|0.4|||Mixed Models Analysis|||||0.4|-1.3|0.319
72344217|NCT02516592|144211044|SUPERIORITY||Mean Difference (Final Values)|-0.04||||0.662|TWO_SIDED|95.0|-0.2|0.13|||Mixed Models Analysis|||||0.13|-0.20|0.662
72344218|NCT04018313|144211067|EQUIVALENCE|The similarity of PK between CT-P39 versus EU-approved Xolair, CT-P39 versus US-licensed Xolair, and EU-approved Xolair versus US-licensed Xolair was concluded if the 90% confidence intervals (CIs) of the ratios of geometric means of each comparison are entirely contained within 80% to 125% for AUC0-inf, AUC0-last, and Cmax.|Ratio of geometric least square means|105.62|||||TWO_SIDED|90.0|95.91|116.31||||||The statistical analysis of the log-transformed primary endpoints was based on an ANCOVA model with treatment as fixed effect and baseline body weight, total IgE level and sex as covariates.||116.31|95.91|
72344219|NCT04018313|144211067|EQUIVALENCE|The similarity of PK between CT-P39 versus EU-approved Xolair, CT-P39 versus US-licensed Xolair, and EU-approved Xolair versus US-licensed Xolair was concluded if the 90% confidence intervals (CIs) of the ratios of geometric means of each comparison are entirely contained within 80% to 125% for AUC0-inf, AUC0-last, and Cmax|Ratio of geometric least square means|98.72|||||TWO_SIDED|90.0|89.76|108.58||||||The statistical analysis of the log-transformed primary endpoints was based on an ANCOVA model with treatment as fixed effect and baseline body weight, total IgE level and sex as covariates.||108.58|89.76|
72344220|NCT04018313|144211067|EQUIVALENCE|The similarity of PK between CT-P39 versus EU-approved Xolair, CT-P39 versus US-licensed Xolair, and EU-approved Xolair versus US-licensed Xolair was concluded if the 90% confidence intervals (CIs) of the ratios of geometric means of each comparison are entirely contained within 80% to 125% for AUC0-inf, AUC0-last, and Cmax.|Ratio of geometric least square means|93.47|||||TWO_SIDED|90.0|85.09|102.68||||||The statistical analysis of the log-transformed primary endpoints was based on an ANCOVA model with treatment as fixed effect and baseline body weight, total IgE level and sex as covariates.||102.68|85.09|
72344221|NCT04018313|144211068|EQUIVALENCE|The similarity of PK between CT-P39 versus EU-approved Xolair, CT-P39 versus US-licensed Xolair, and EU-approved Xolair versus US-licensed Xolair was concluded if the 90% confidence intervals (CIs) of the ratios of geometric means of each comparison are entirely contained within 80% to 125% for AUC0-inf, AUC0-last, and Cmax.|Ratio of geometric least square means|104.0|||||TWO_SIDED|90.0|94.96|113.89||||||The statistical analysis of the log-transformed primary endpoints was based on an ANCOVA model with treatment as fixed effect and baseline body weight, total IgE level and sex as covariates.||113.89|94.96|
72344222|NCT04018313|144211068|EQUIVALENCE|The similarity of PK between CT-P39 versus EU-approved Xolair, CT-P39 versus US-licensed Xolair, and EU-approved Xolair versus US-licensed Xolair was concluded if the 90% confidence intervals (CIs) of the ratios of geometric means of each comparison are entirely contained within 80% to 125% for AUC0-inf, AUC0-last, and Cmax.|Ratio of geometric least square means|99.3|||||TWO_SIDED|90.0|90.79|108.61||||||The statistical analysis of the log-transformed primary endpoints was based on an ANCOVA model with treatment as fixed effect and baseline body weight, total IgE level and sex as covariates.||108.61|90.79|
72344223|NCT04018313|144211068|EQUIVALENCE|The similarity of PK between CT-P39 versus EU-approved Xolair, CT-P39 versus US-licensed Xolair, and EU-approved Xolair versus US-licensed Xolair was concluded if the 90% confidence intervals (CIs) of the ratios of geometric means of each comparison are entirely contained within 80% to 125% for AUC0-inf, AUC0-last, and Cmax.|Ratio of geometric least square means|95.48|||||TWO_SIDED|90.0|87.36|104.37||||||The statistical analysis of the log-transformed primary endpoints was based on an ANCOVA model with treatment as fixed effect and baseline body weight, total IgE level and sex as covariates.||104.37|87.36|
72428713|NCT04147260|144368581|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|-0.35|STANDARD_ERROR_OF_MEAN|0.132||0.01|TWO_SIDED|90.0|-0.62|-0.09||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||-0.09|-0.62|0.010
72428714|NCT04147260|144368581|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|0.59|STANDARD_ERROR_OF_MEAN|0.173||0.001|TWO_SIDED|90.0|0.24|0.93||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||0.93|0.24|0.001
72428715|NCT04147260|144368582|EQUIVALENCE|Two-sided 90% CI with an acceptance range of -0.4 to 0.4|Mean Difference (Final Values)|0.03|STANDARD_ERROR_OF_MEAN|0.044|||TWO_SIDED|90.0|-0.05|0.1|||Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values||0.10|-0.05|
72428716|NCT04147260|144368582|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.038||0.998|TWO_SIDED|90.0|-0.08|0.08||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||0.08|-0.08|0.998
72428717|NCT04147260|144368582|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.05||0.618|TWO_SIDED|90.0|-0.08|0.13||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||0.13|-0.08|0.618
72428718|NCT04147260|144368582|EQUIVALENCE|Two-sided 90% CI with an acceptance range of -0.4 to 0.4|Mean Difference (Final Values)|0.06|STANDARD_ERROR_OF_MEAN|0.099|||TWO_SIDED|90.0|-0.1|0.23|||Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values||0.23|-0.10|
72428719|NCT04147260|144368582|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|0.06|STANDARD_ERROR_OF_MEAN|0.081||0.451|TWO_SIDED|90.0|-0.1|0.23||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||0.23|-0.10|0.451
72428720|NCT04147260|144368582|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.11||1|TWO_SIDED|90.0|-0.22|0.22||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||0.22|-0.22|1.000
72428721|NCT04147260|144368583|EQUIVALENCE|Two-sided 90% CI with an acceptance range of -0.4 to 0.4|Mean Difference (Final Values)|0.11|STANDARD_ERROR_OF_MEAN|0.152|||TWO_SIDED|90.0|-0.15|0.36|||Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values||0.36|-0.15|
72428722|NCT04147260|144368583|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.131||0.446|TWO_SIDED|90.0|-0.16|0.36||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||0.36|-0.16|0.446
72428723|NCT04147260|144368583|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.172||0.972|TWO_SIDED|90.0|-0.34|0.35||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||0.35|-0.34|0.972
72428724|NCT04147260|144368583|EQUIVALENCE|Two-sided 90% CI with an acceptance range of -0.4 to 0.4|Mean Difference (Final Values)|0.29|STANDARD_ERROR_OF_MEAN|0.182|||TWO_SIDED|90.0|-0.02|0.6|||Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values||0.60|-0.02|
72428725|NCT04147260|144368583|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|0.26|STANDARD_ERROR_OF_MEAN|0.15||0.091|TWO_SIDED|90.0|-0.04|0.56||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||0.56|-0.04|0.091
72428726|NCT04147260|144368583|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|0.03|STANDARD_ERROR_OF_MEAN|0.203||0.88|TWO_SIDED|90.0|-0.38|0.44||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||0.44|-0.38|0.880
72428727|NCT04147260|144368584|EQUIVALENCE|Two-sided 90% CI with an acceptance range of -0.4 to 0.4|Mean Difference (Final Values)|-0.08|STANDARD_ERROR_OF_MEAN|0.043|||TWO_SIDED|90.0|-0.15|-0.01|||Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values||-0.01|-0.15|
72428728|NCT04147260|144368584|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.037||0.757|TWO_SIDED|90.0|-0.09|0.06||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||0.06|-0.09|0.757
72428729|NCT04147260|144368584|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|-0.07|STANDARD_ERROR_OF_MEAN|0.049||0.158|TWO_SIDED|90.0|-0.17|0.03||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||0.03|-0.17|0.158
72344224|NCT04018313|144211069|EQUIVALENCE|The similarity of PK between CT-P39 versus EU-approved Xolair, CT-P39 versus US-licensed Xolair, and EU-approved Xolair versus US-licensed Xolair was concluded if the 90% confidence intervals (CIs) of the ratios of geometric means of each comparison are entirely contained within 80% to 125% for AUC0-inf, AUC0-last, and Cmax.|Ratio of geometric least square means|113.14|||||TWO_SIDED|90.0|103.15|124.11||||||The statistical analysis of the log-transformed primary endpoints was based on an ANCOVA model with treatment as fixed effect and baseline body weight, total IgE level and sex as covariates.||124.11|103.15|
72344225|NCT04018313|144211069|EQUIVALENCE|The similarity of PK between CT-P39 versus EU-approved Xolair, CT-P39 versus US-licensed Xolair, and EU-approved Xolair versus US-licensed Xolair was concluded if the 90% confidence intervals (CIs) of the ratios of geometric means of each comparison are entirely contained within 80% to 125% for AUC0-inf, AUC0-last, and Cmax.|Ratio of geometric least square means|103.88|||||TWO_SIDED|90.0|94.83|113.8||||||The statistical analysis of the log-transformed primary endpoints was based on an ANCOVA model with treatment as fixed effect and baseline body weight, total IgE level and sex as covariates.||113.80|94.83|
72344226|NCT04018313|144211069|EQUIVALENCE|The similarity of PK between CT-P39 versus EU-approved Xolair, CT-P39 versus US-licensed Xolair, and EU-approved Xolair versus US-licensed Xolair was concluded if the 90% confidence intervals (CIs) of the ratios of geometric means of each comparison are entirely contained within 80% to 125% for AUC0-inf, AUC0-last, and Cmax.|Ratio of geometric least square means|91.82|||||TWO_SIDED|90.0|83.87|100.52||||||The statistical analysis of the log-transformed primary endpoints was based on an ANCOVA model with treatment as fixed effect and baseline body weight, total IgE level and sex as covariates.||100.52|83.87|
72344227|NCT04566692|144211137|NON_INFERIORITY|The bi-weekly treatment was considered non-inferior to the weekly treatment if the lower bound of the 90% CI was \> 0.8.|GLSM Ratio|1.035|||||TWO_SIDED|90.0|1.003|1.0685||||||Geometric least-squares means (GLSMs), GLSM ratio, and 90% CI of GLSM ratio were determined from a mixed-effect model for the log-transformed parameter value with treatment period (weekly or bi-weekly) as a fixed effect and participant as a random effect.||1.0685|1.0030|
72344228|NCT04566692|144211140|NON_INFERIORITY|The biweekly treatment was considered non-inferior to the weekly treatment if the lower bound of the 90% CI was \> 0.8.|GLSM Ratio|0.97|||||TWO_SIDED|90.0|0.9447|0.9957||||||GLSMs, GLSM ratio, and 90% CI of GLSM ratio were determined from a mixed-effect model for the log-transformed parameter value with treatment period (weekly or bi-weekly) as a fixed effect and participants as a random effect.||0.9957|0.9447|
72344229|NCT03927404|144211160|OTHER|We used median (Inter-quartile range) to describe the continuous measures of limb health such as TEWL, Hydration, and Oxygenation levels at each visit and each location of the measurements in the sound (SL) and residual limbs (RL).|||||<|0.05||||||In a bivariate analysis, we used two-sided equality of the median test for the matched pairs of observations|bivariate analysis|||||||<0.05
72344230|NCT03927404|144211162|OTHER|We used median (Inter-quartile range) to describe the continuous measures of limb health such as TEWL, Hydration, and Oxygenation levels at each visit and each location of the measurements in the sound (SL) and residual limbs (RL).||||||0.05||||||In a bivariate analysis, we used two-sided equality of the median test for the matched pairs of observations|bivariate analysis|||||||0.05
72428730|NCT04147260|144368584|EQUIVALENCE|Two-sided 90% CI with an acceptance range of -0.4 to 0.4|Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.101|||TWO_SIDED|90.0|-0.12|0.22|||Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values||0.22|-0.12|
72344231|NCT02533726|144211165|SUPERIORITY||Odds Ratio (OR)|0.27||||0.012|TWO_SIDED|95.0|0.1|0.75|||Fisher Exact|||Per-protocol (PP) analysis, consistent with regulatory guidance (FDA).||.75|.1|.012
72344232|NCT02533726|144211165|OTHER||Odds Ratio (OR)|0.2||||0.015|TWO_SIDED|95.0|0.06|0.74|||Fisher Exact|||Per protocol analysis adjusted for admitting team, unit of admission, and risk for pressure injury.||0.74|0.06|0.015
72344233|NCT01147848|144211167|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.037||||0.162|TWO_SIDED|95.0|-0.088|0.015|||ANCOVA||Analysis was performed using ANCOVA with covariates of Baseline FEV1, region, sex, age, and treatment.|||0.015|-0.088|0.162
72344234|NCT02277925|144211219|SUPERIORITY||Risk Ratio (RR)|1.74||||0.3|TWO_SIDED|95.0|0.59|5.14|||Chi-squared|||||5.14|0.59|0.30
72344235|NCT02277925|144211220|SUPERIORITY||Risk Ratio (RR)|1.03||||0.43|TWO_SIDED|95.0|0.96|1.11|||Chi-squared|||||1.11|0.96|0.43
72344236|NCT02277925|144211221|SUPERIORITY||Mean Difference (Final Values)|-4.5||||0.39|TWO_SIDED|95.0|-14.7|5.7|||t-test, 2 sided|||||5.7|-14.7|0.39
72344237|NCT02473367|144211335|SUPERIORITY_OR_OTHER||Geom. least-squares mean ratio (GLSMR)|0.28|||||TWO_SIDED|90.0|0.24|0.32|||||Raltegravir+TUMS/Raltegravir only|||0.32|0.24|
72344238|NCT02473367|144211335|SUPERIORITY_OR_OTHER||GLSMR|0.86|||||TWO_SIDED|90.0|0.73|1.03|||||Raltegravir+12 Hrs Leader Antacid/Raltegravir only|||1.03|0.73|
72344239|NCT02473367|144211335|SUPERIORITY_OR_OTHER||GLSMR|0.9|||||TWO_SIDED|90.0|0.8|1.03|||||Raltegravir+12 Hrs TUMS/Raltegravir only|||1.03|0.80|
72344240|NCT02473367|144211336|SUPERIORITY_OR_OTHER||GLSMR|0.26|||||TWO_SIDED|90.0|0.21|0.32|||||Raltegravir+TUMS/Raltegravir only|||0.32|0.21|
72344241|NCT02473367|144211336|SUPERIORITY_OR_OTHER||GLSMR|0.86|||||TWO_SIDED|90.0|0.65|1.15|||||Raltegravir+12 Hrs Leader Antacid/Raltegravir only|||1.15|0.65|
72344242|NCT02473367|144211336|SUPERIORITY_OR_OTHER||GLSMR|0.98|||||TWO_SIDED|90.0|0.81|1.17|||||Raltegravir+12 Hrs TUMS/Raltegravir only|||1.17|0.81|
72344243|NCT02473367|144211337|SUPERIORITY_OR_OTHER||GLSMR|0.52|||||TWO_SIDED|90.0|0.45|0.61|||||Raltegravir+TUMS/Raltegravir only|||0.61|0.45|
72344244|NCT02473367|144211337|SUPERIORITY_OR_OTHER||GLSMR|0.42|||||TWO_SIDED|90.0|0.34|0.52|||||Raltegravir+12 Hrs Leader Antacid/Raltegravir only|||0.52|0.34|
72344245|NCT02473367|144211337|SUPERIORITY_OR_OTHER||GLSMR|0.43|||||TWO_SIDED|90.0|0.36|0.51|||||Raltegravir+12 Hrs TUMS/Raltegravir only|||0.51|0.36|
72344246|NCT02678923|144211338|SUPERIORITY||LS mean difference|0.73||||0.0738|TWO_SIDED|95.0|-0.07|1.52||Baseline parameter value as a covariate and treatment group as factor, adjusting for country and prior statin use.|ANCOVA|||||1.52|-0.07|0.0738
72344247|NCT01641822|144211364|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.743||||0.25|TWO_SIDED|95.0|0.446|1.238|||Negative binomial regression|||Ratio between rates||1.238|0.446|0.25
72344248|NCT01641822|144211365|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.33||||0.16|TWO_SIDED|95.0|-0.55|3.2||The p-value is from an MMRM analysis. The model includes terms for baseline value, previous exacerbations (1, 2, ≥ 3), treatment, visit (categorical), and treatment by visit interaction.|Mixed Models Analysis|||Difference in change in FEV1 % predicted||3.2|-0.55|0.16
72344249|NCT01641822|144211366|SUPERIORITY_OR_OTHER|||||||0.67|TWO_SIDED||||||Fisher Exact|||Comparison of percentages||||0.67
72344250|NCT01641822|144211367|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.89||||0.71|TWO_SIDED|95.0|0.5|1.59|||Log Rank|||Comparison of time to exacerbation||1.59|0.50|0.71
72344251|NCT01641822|144211368|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.642||||0.14|TWO_SIDED|95.0|0.355|1.164|||Negative binomial regression|||Comparison of hospitalization rate||1.164|0.355|0.14
72344252|NCT01641822|144211369|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.06||||0.21|TWO_SIDED|95.0|-1.71|7.82||The p-value is from an MMRM analysis. The model includes terms for baseline value, previous exacerbations (1, 2, ≥ 3), treatment, visit (categorical), and treatment by visit interaction.|Mixed Models Analysis|||Difference in change in CFQ-R RSS||7.82|-1.71|0.21
72344253|NCT00454584|144211370|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel (CMH) chi square|The test was stratified by baseline weight \[\<90kg vs. ≥ 90 kg).||||||<0.001
72428731|NCT04147260|144368584|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|0.08|STANDARD_ERROR_OF_MEAN|0.083||0.33|TWO_SIDED|90.0|-0.09|0.25||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||0.25|-0.09|0.330
72428732|NCT04147260|144368584|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|-0.04|STANDARD_ERROR_OF_MEAN|0.113||0.754|TWO_SIDED|90.0|-0.26|0.19||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||0.19|-0.26|0.754
72428733|NCT04147260|144368585|EQUIVALENCE|Two-sided 90% CI with an acceptance range of -0.4 to 0.4|Mean Difference (Final Values)|0.31|STANDARD_ERROR_OF_MEAN|0.128|||TWO_SIDED|90.0|0.09|0.52|||Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values||0.52|0.09|
72344254|NCT00454584|144211370|SUPERIORITY_OR_OTHER|||||||0.012||95.0||||To control the overall type I error rate at 0.05 level in the primary endpoint analysis, a step-down test procedure was applied. First, ustekinumab 90 mg and etanercept were compared. Then ustekinumab 45 mg and etanercept would be compared.|Cochran-Mantel-Haenszel (CMH) chi square|The test was stratified by baseline weight \[\<90kg vs. ≥ 90 kg).||Null Hypothesis: No difference between ustekinumab 90 mg or 45 mg and etanercept at an overall significant level of 0.05. Sample Size: Assuming the PASI 75 response rates of ustekinumab 90 mg, 45 mg, etanercept are 65%, 64%, and 50% , respectively, with 325 participants each in the ustekinumab 90 mg and etanercept groups, the power to detect a treatment difference is 97%. With 200 participants in the ustekinumab 45 mg group, the complete power to further detect a treatment difference was 87%.||||0.012
72344255|NCT00454584|144211371|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel (CMH) chi square|The test was stratified by baseline weight \[\<90kg vs. ≥ 90 kg).||||||<0.001
72344256|NCT00454584|144211371|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel (CMH) chi square|The test was stratified by baseline weight \[\<90kg vs. ≥ 90 kg).||Null Hypothesis: No difference between ustekinumab 90 mg or 45 mg and etanercept at an overall significant level of 0.05.||||<0.001
72344257|NCT00454584|144211372|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel (CMH) chi square|The test was stratified by baseline weight \[\<90kg vs. ≥ 90 kg).||||||<0.001
72344258|NCT00454584|144211372|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel (CMH) chi square|The test was stratified by baseline weight \[\<90kg vs. ≥ 90 kg).||Null Hypothesis: No difference between ustekinumab 90 mg or 45 mg and etanercept at an overall significant level of 0.05.||||<0.001
72344259|NCT00599638|144211376|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Mean Difference|0.08|STANDARD_ERROR_OF_MEAN|0.306||0.391|TWO_SIDED|80.0|-0.31|0.48|||Mixed Models Analysis|||||0.48|-0.31|0.3910
72344260|NCT00599638|144211376|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Mean Difference|-1.32|STANDARD_ERROR_OF_MEAN|0.357||0.0002|TWO_SIDED|80.0|-1.78|-0.86|||Mixed Models Analysis|||||-0.86|-1.78|0.0002
72344261|NCT00599638|144211377|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.0055||||0.4959|TWO_SIDED|80.0|0.3|1.71|||Regression, Logistic|||The statistical analysis was performed compositely for all categories.||1.71|0.30|0.4959
72344262|NCT00599638|144211377|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|5.0763||||0.0011|TWO_SIDED|80.0|1.69|8.46|||Regression, Logistic|||The statistical analysis was performed compositely for all categories.||8.46|1.69|0.0011
72344263|NCT00599638|144211379|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Mean Difference|1.18|STANDARD_ERROR_OF_MEAN|2.819||0.338|TWO_SIDED|80.0|-2.47|4.84|||Mixed Models Analysis|||||4.84|-2.47|0.3380
72344264|NCT00599638|144211379|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Mean Difference|-9.65|STANDARD_ERROR_OF_MEAN|3.268||0.0022|TWO_SIDED|80.0|-13.89|-5.42|||Mixed Models Analysis|||||-5.42|-13.89|0.0022
72344265|NCT04783077|144211397|SUPERIORITY||Odds Ratio (OR)|2.28||||0.23|TWO_SIDED|95.0|0.61|8.5|||Regression, Logistic||The estimated odds ratio of return donation attempt represents WhatsApp compared to control.|The primary analysis applies only to the RCT participants (N=130). Docudrama participants were not assessed for return blood donation. Analysis used fitted logistic regression with outcome donation attempted (Y/N) on the modiﬁed intention-to-treat (mITT) population, adjusted for type of donor (FRD, VNRBD).|Missing data on the primary outcome from the mITT analysis was handled using multiple imputation via chained equations with 50 imputations, and included stratum, group assignment (WhatsApp, Control) and ethnicity. Ethnicity was the only baseline variable with a minimum Kendall's tau of 0.2 with donation attempt.|8.50|0.61|0.23
72344266|NCT01727336|144211420|OTHER||recommended dose for Part 2|0.9|||||TWO_SIDED||||||||The recommended dose level for Part 2 was determined to be 0.9 mg/kg|||||
72344267|NCT00849862|144211434|NON_INFERIORITY_OR_EQUIVALENCE|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Geometric Test/Ref Ratio x 100|92.2||||||90.0|85.0|100.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||100|85.0|
72344268|NCT00849862|144211435|NON_INFERIORITY_OR_EQUIVALENCE|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Geometric Test/Ref Ratio x 100|100.0||||||90.0|96.3|104.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||104|96.3|
72344269|NCT00849862|144211436|NON_INFERIORITY_OR_EQUIVALENCE|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Geometric Test/Ref Ratio x 100|99.6||||||90.0|96.2|103.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||103|96.2|
72344270|NCT01532869|144211438|SUPERIORITY_OR_OTHER||Difference in Least Square (LS) mean|-2.7||||0.0915|TWO_SIDED|95.0|-5.85|0.45|||Mixed Models Analysis|||The analysis included the fixed, categorical effects of treatment, visit, the stratification factor of joint involvement at the baseline visit, and treatment-by-visit interaction, as well as the continuous covariates of baseline score and baseline score-by-visit interaction.||0.45|-5.85|0.0915
72344271|NCT01532869|144211440|SUPERIORITY_OR_OTHER||Difference in LS mean|-0.43||||0.9336|TWO_SIDED|95.0|-10.78|9.91|||Mixed Models Analysis|||Change From Baseline in Intestinal VAS Score at Week 24. The analysis included the fixed, categorical effects of treatment, visit, the stratification factor of joint involvement at the baseline visit, and treatment-by-visit interaction, as well as the continuous covariates of baseline score and baseline score-by-visit interaction.||9.91|-10.78|0.9336
72344272|NCT01532869|144211440|SUPERIORITY_OR_OTHER||Difference in LS mean|-4.12||||0.4609|TWO_SIDED|95.0|-15.21|6.96|||Mixed Models Analysis|||Change From Baseline in Breathing VAS Score at Week 24. The analysis included the fixed, categorical effects of treatment, visit, the stratification factor of joint involvement at the baseline visit, and treatment-by-visit interaction, as well as the continuous covariates of baseline score and baseline score-by-visit interaction.||6.96|-15.21|0.4609
72344273|NCT01532869|144211440|SUPERIORITY_OR_OTHER||Difference in LS mean|-1.28||||0.8493|TWO_SIDED|95.0|-14.7|12.13|||Mixed Models Analysis|||Change From Baseline in Raynaud Syndrome Score at Week 24. The analysis included the fixed, categorical effects of treatment, visit, the stratification factor of joint involvement at the baseline visit, and treatment-by-visit interaction, as well as the continuous covariates of baseline score and baseline score-by-visit interaction.||12.13|-14.70|0.8493
72428734|NCT04147260|144368585|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|0.16|STANDARD_ERROR_OF_MEAN|0.11||0.151|TWO_SIDED|90.0|-0.06|0.38||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||0.38|-0.06|0.151
72428735|NCT04147260|144368585|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|0.15|STANDARD_ERROR_OF_MEAN|0.145||0.319|TWO_SIDED|90.0|-0.15|0.44||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||0.44|-0.15|0.319
72428736|NCT04147260|144368585|EQUIVALENCE|Two-sided 90% CI with an acceptance range of -0.4 to 0.4|Mean Difference (Final Values)|0.19|STANDARD_ERROR_OF_MEAN|0.136|||TWO_SIDED|90.0|-0.04|0.42|||Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values||0.42|-0.04|
72428737|NCT04147260|144368585|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|0.13|STANDARD_ERROR_OF_MEAN|0.112||0.246|TWO_SIDED|90.0|-0.09|0.36||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||0.36|-0.09|0.246
72344274|NCT01532869|144211440|SUPERIORITY_OR_OTHER||Difference in LS mean|4.89||||0.4717|TWO_SIDED|95.0|-8.59|18.37|||Mixed Models Analysis|||Change From Baseline in Finger Ulcers Score at Week 24. The analysis included the fixed, categorical effects of treatment, visit, the stratification factor of joint involvement at the baseline visit, and treatment-by-visit interaction, as well as the continuous covariates of baseline score and baseline score-by-visit interaction.||18.37|-8.59|0.4717
72344275|NCT01532869|144211440|SUPERIORITY_OR_OTHER||Difference in LS mean|-0.08||||0.9876|TWO_SIDED|95.0|-9.93|9.78|||Mixed Models Analysis|||Change From Baseline in Overall Disease Score at Week 24. The analysis included the fixed, categorical effects of treatment, visit, the stratification factor of joint involvement at the baseline visit, and treatment-by-visit interaction, as well as the continuous covariates of baseline score and baseline score-by-visit interaction.||9.78|-9.93|0.9876
72344276|NCT01532869|144211440|SUPERIORITY_OR_OTHER||Difference in LS mean|-6.8||||0.2407|TWO_SIDED|95.0|-18.3|4.71|||Mixed Models Analysis|||Change From Baseline in Intestinal VAS Score at Week 48. The analysis included the fixed, categorical effects of treatment, visit, the stratification factor of joint involvement at the baseline visit, and treatment-by-visit interaction, as well as the continuous covariates of baseline score and baseline score-by-visit interaction.||4.71|-18.30|0.2407
72344277|NCT01532869|144211440|SUPERIORITY_OR_OTHER||Difference in LS mean|1.54||||0.7742|TWO_SIDED|95.0|-9.18|12.26|||Mixed Models Analysis|||Change From Baseline in Breathing VAS Score at Week 48. The analysis included the fixed, categorical effects of treatment, visit, the stratification factor of joint involvement at the baseline visit, and treatment-by-visit interaction, as well as the continuous covariates of baseline score and baseline score-by-visit interaction.||12.26|-9.18|0.7742
72344278|NCT01532869|144211440|SUPERIORITY_OR_OTHER||Difference in LS mean|-4.48||||0.5182|TWO_SIDED|95.0|-18.28|9.31|||Mixed Models Analysis|||Change From Baseline in Raynaud Syndrome Score at Week 48. The analysis included the fixed, categorical effects of treatment, visit, the stratification factor of joint involvement at the baseline visit, and treatment-by-visit interaction, as well as the continuous covariates of baseline score and baseline score-by-visit interaction.||9.31|-18.28|0.5182
72344279|NCT01532869|144211440|SUPERIORITY_OR_OTHER||Difference in LS mean|-5.8||||0.3106|TWO_SIDED|95.0|-17.2|5.59|||Mixed Models Analysis|||Change From Baseline in Finger Ulcers Score at Week 48. The analysis included the fixed, categorical effects of treatment, visit, the stratification factor of joint involvement at the baseline visit, and treatment-by-visit interaction, as well as the continuous covariates of baseline score and baseline score-by-visit interaction.||5.59|-17.20|0.3106
72344280|NCT01532869|144211440|SUPERIORITY_OR_OTHER||Difference in LS mean|-7.82||||0.1717|TWO_SIDED|95.0|-19.11|3.48|||Mixed Models Analysis|||Change From Baseline in Overall Disease Score at Week 48. The analysis included the fixed, categorical effects of treatment, visit, the stratification factor of joint involvement at the baseline visit, and treatment-by-visit interaction, as well as the continuous covariates of baseline score and baseline score-by-visit interaction.||3.48|-19.11|0.1717
72344281|NCT01532869|144211441|SUPERIORITY_OR_OTHER||Difference in LS mean|0.02||||0.8503|TWO_SIDED|95.0|-0.186|0.225|||Mixed Models Analysis|||Change From Baseline in HAQ-DI Score at Week 24. The analysis included the fixed, categorical effects of treatment, visit, the stratification factor of joint involvement at the baseline visit, and treatment-by-visit interaction, as well as the continuous covariates of baseline score and baseline score-by-visit interaction||0.225|-0.186|0.8503
72344282|NCT01532869|144211441|SUPERIORITY_OR_OTHER||Difference in LS mean|-0.207||||0.1212|TWO_SIDED|95.0|-0.471|0.056|||Mixed Models Analysis|||Change From Baseline in HAQ-DI Score at Week 48. The analysis included the fixed, categorical effects of treatment, visit, the stratification factor of joint involvement at the baseline visit, and treatment-by-visit interaction, as well as the continuous covariates of baseline score and baseline score-by-visit interaction.||0.056|-0.471|0.1212
72344283|NCT01532869|144211442|SUPERIORITY_OR_OTHER||Difference in LS mean|-0.99||||0.8118|TWO_SIDED|95.0|-9.2|7.23|||Mixed Models Analysis|||Change From Baseline in Clinician's Global Assessment at Week 24.The analysis included the fixed, categorical effects of treatment, visit, the stratification factor of joint involvement at the baseline visit, and treatment-by-visit interaction, as well as the continuous covariates of baseline score and baseline score-by-visit interaction.||7.23|-9.20|0.8118
72344284|NCT01532869|144211442|SUPERIORITY_OR_OTHER||Difference in LS mean|-9.02||||0.0768|TWO_SIDED|95.0|-19.04|1.0|||Mixed Models Analysis|||Change From Baseline in Clinician's Global Assessment at Week 48.The analysis included the fixed, categorical effects of treatment, visit, the stratification factor of joint involvement at the baseline visit, and treatment-by-visit interaction, as well as the continuous covariates of baseline score and baseline score-by-visit interaction.||1.00|-19.04|0.0768
72344285|NCT01532869|144211443|SUPERIORITY_OR_OTHER||Difference in LS mean|-3.85||||0.4063|TWO_SIDED|95.0|-13.04|5.34|||Mixed Models Analysis|||Change From Baseline in Patient's Global Assessment at Week 24. The analysis included the fixed, categorical effects of treatment, visit, the stratification factor of joint involvement at the baseline visit, and treatment-by-visit interaction, as well as the continuous covariates of baseline score and baseline score-by-visit interaction.||5.34|-13.04|0.4063
72344286|NCT01532869|144211443|SUPERIORITY_OR_OTHER||Difference in LS mean|-8.3||||0.1371|TWO_SIDED|95.0|-19.31|2.71|||Mixed Models Analysis|||Change From Baseline in Patient's Global Assessment at Week 48. The analysis included the fixed, categorical effects of treatment, visit, the stratification factor of joint involvement at the baseline visit, and treatment-by-visit interaction, as well as the continuous covariates of baseline score and baseline score-by-visit interaction.||2.71|-19.31|0.1371
72428738|NCT04147260|144368585|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|0.06|STANDARD_ERROR_OF_MEAN|0.151||0.704|TWO_SIDED|90.0|-0.25|0.36||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||0.36|-0.25|0.704
72344287|NCT01532869|144211444|SUPERIORITY_OR_OTHER||Difference in LS mean|1.43||||0.5197|TWO_SIDED|95.0|-2.97|5.82|||Mixed Models Analysis|||Change From Baseline in FACIT-Fatigue Score at Week 24. The analysis included the fixed, categorical effects of treatment, visit, the stratification factor of joint involvement at the baseline visit, and treatment-by-visit interaction, as well as the continuous covariates of baseline score and baseline score-by-visit interaction.||5.82|-2.97|0.5197
72344288|NCT01532869|144211444|SUPERIORITY_OR_OTHER||Difference in LS mean|2.75||||0.1886|TWO_SIDED|95.0|-1.38|6.88|||Mixed Models Analysis|||Change From Baseline in FACIT-Fatigue Score at Week 48. The analysis included the fixed, categorical effects of treatment, visit, the stratification factor of joint involvement at the baseline visit, and treatment-by-visit interaction, as well as the continuous covariates of baseline score and baseline score-by-visit interaction.||6.88|-1.38|0.1886
72344289|NCT01532869|144211445|SUPERIORITY_OR_OTHER||Difference in LS mean|0.79||||0.3651|TWO_SIDED|95.0|-0.94|2.51|||Mixed Models Analysis|||Change From Baseline in 5-D Itch Scale at Week 24. The analysis included the fixed, categorical effects of treatment, visit, the stratification factor of joint involvement at the baseline visit, and treatment-by-visit interaction, as well as the continuous covariates of baseline score and baseline score-by-visit interaction.||2.51|-0.94|0.3651
72344290|NCT01532869|144211445|SUPERIORITY_OR_OTHER||Difference in LS mean|-1.11||||0.2841|TWO_SIDED|95.0|-3.16|0.94|||Mixed Models Analysis|||Change From Baseline in 5-D Itch Scale at Week 48. The analysis included the fixed, categorical effects of treatment, visit, the stratification factor of joint involvement at the baseline visit, and treatment-by-visit interaction, as well as the continuous covariates of baseline score and baseline score-by-visit interaction.||0.94|-3.16|0.2841
72344291|NCT01532869|144211446|SUPERIORITY_OR_OTHER||Difference in LS mean|-3.55||||0.0579|TWO_SIDED|95.0|-7.23|0.12|||Mixed Models Analysis|||The analysis included the fixed, categorical effects of treatment, visit, the stratification factor of joint involvement at the baseline visit, and treatment-by-visit interaction, as well as the continuous covariates of baseline score and baseline score-by-visit interaction.||0.12|-7.23|0.0579
72344292|NCT01532869|144211447|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.39|STANDARD_ERROR_OF_MEAN|0.704||0.2159|TWO_SIDED|95.0|0.6|9.5|||Regression, Logistic|||The logistic regression model included the fixed categorical effects of treatment and the stratification factor of joint involvement at the baseline visit. The continuous covariate of baseline mRSS score was also included in the model.||9.50|0.60|0.2159
72344293|NCT01424228|144211453|SUPERIORITY_OR_OTHER_LEGACY|||||||0.367|||||||Cochran-Mantel-Haenszel|||||||0.367
72344294|NCT01229449|144211470|SUPERIORITY||||||<|0.0001|||||||ANOVA|||||||<0.0001
72344295|NCT01229449|144211470|SUPERIORITY||||||<|0.0001|||||||ANOVA|||||||<0.0001
72344296|NCT01229449|144211470|SUPERIORITY|||||||0.0001|||||||ANOVA|||||||0.0001
72344297|NCT01229449|144211470|SUPERIORITY|||||||0.0001|||||||ANOVA|||||||0.0001
72344298|NCT01229449|144211470|SUPERIORITY|||||||0.72|||||||ANOVA|||||||0.72
72344299|NCT01229449|144211470|SUPERIORITY||||||<|0.0001|||||||ANOVA|||||||<0.0001
72344300|NCT01229449|144211470|SUPERIORITY|||||||0.0005|||||||ANOVA|||||||0.0005
72344301|NCT01229449|144211470|SUPERIORITY|||||||0.0005|||||||ANOVA|||||||0.0005
72344302|NCT01229449|144211470|SUPERIORITY||||||<|0.0001|||||||ANOVA|||||||<0.0001
72344303|NCT01229449|144211470|SUPERIORITY||||||<|0.0001|||||||ANOVA|||||||<0.0001
72344304|NCT04484207|144211489|SUPERIORITY|||||||0.031|||||||GEE|||||||0.031
72344305|NCT03596450|144211492|SUPERIORITY||Treatment effect|1.36||||0.033|TWO_SIDED|95.0|1.03|1.79|||Regression, Logistic|||Estimate and p-value are based on logistic regression model with logit link function, treatment as categorical effect, and baseline HbA1c as covariate.||1.79|1.03|0.033
72344306|NCT03037983|144211561|SUPERIORITY||Mean Difference (Net)|1.38||||0.849|TWO_SIDED||||||t-test, 2 sided|||||||.849
72428739|NCT04147260|144368586|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|-1.96|STANDARD_ERROR_OF_MEAN|4.929||0.692|TWO_SIDED|90.0|-11.92|7.99||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||7.99|-11.92|0.692
72344307|NCT03037983|144211563|SUPERIORITY||Mean Difference (Net)|0.5||||0.782|TWO_SIDED|||||t = 0.287|t-test, 2 sided|||||||.782
72344308|NCT02332291|144211625|SUPERIORITY||Odds Ratio, log|0.8642|STANDARD_ERROR_OF_MEAN|0.475||0.0689|TWO_SIDED|||||The p-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was \< 0.05.|Regression, Logistic|||Statistical analyses utilized a logistic regression model with remission status (defined as final MADRS \<= 7) as the dependent variable. The independent variable of interest was treatment arm assignment, and the model included age, sex, and baseline depression severity by MADRS as covariates.||||0.0689
72344309|NCT02332291|144211626|SUPERIORITY||Slope, fixed effect|-1.066|STANDARD_ERROR_OF_MEAN|0.264||0.0001|TWO_SIDED|||||The p-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|344 degrees of freedom||Statistical analyses utilized mixed model. MADRS score was the repeated measures dependent variable. Independent variables included time, age, sex, and treatment assignment. The primary variable of interest for this analysis was an interaction term between time and treatment assignment. A statistically significant interaction term would indicate that one treatment arm experienced a greater change in MADRS score over time than the other treatment arm.||||0.0001
72344310|NCT02332291|144211627|SUPERIORITY||Slope, fixed effects|-0.3117|STANDARD_ERROR_OF_MEAN|0.1566||0.0483|TWO_SIDED|||||The p-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was \< 0.05.|Mixed Models Analysis|150 degrees of freedom||Statistical analyses utilized mixed models, with QIDS score being the repeated measures dependent variable. Independent variables included time, age, sex, and treatment assignment. The primary variable of interest was an interaction term between time and treatment assignment.||||0.0483
72344311|NCT02332291|144211628|OTHER|Analyses tested for effects of time in this one-arm, open-label study phase.|Slope, fixed effect|-1.186|STANDARD_ERROR_OF_MEAN|0.181|<|0.0001|TWO_SIDED|||||The p-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|128 degrees of freedom||Statistical analyses utilized mixed models, with MADRS score being the repeated measures dependent variable. Independent variables included time, age, and sex. The primary variable of interest was time, to indicate a change in depression severity over time with open-label treatment.||||<0.0001
72344312|NCT02332291|144211629|OTHER|Analyses tested for effects of time in this one-arm, open-label study phase.|Slope, fixed effects|-0.2342|STANDARD_ERROR_OF_MEAN|0.0908||0.0123|TWO_SIDED|||||The p-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|61 degrees of freedom||Statistical analyses utilized mixed models, with QIDS score being the repeated measures dependent variable. Independent variables included time, age, and sex. The primary variable of interest was time, to indicate a change in depression severity over time with open-label treatment.||||0.0123
72344313|NCT02332291|144211630|SUPERIORITY||Slope|-0.636|STANDARD_ERROR_OF_MEAN|1.924||0.742|TWO_SIDED|||||The p-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was p \< 0.05.|Regression, Linear|||Statistical analyses used a linear model. Final AES score at week 8 was the dependent variable. Independent variables included age, sex, baseline AES score, baseline MADRS score, and treatment assignment. Treatment assignment was the independent variable of interest.||||0.742
72344314|NCT02332291|144211631|SUPERIORITY||Slope|-5.4705|STANDARD_ERROR_OF_MEAN|2.352||0.0232|TWO_SIDED|||||The p-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was p \< 0.05.|Regression, Linear|||Statistical analyses used a linear regression model. Final RRS score at week 8 was the dependent variable. Independent variables included age, sex, baseline RRS score, baseline MADRS score, and treatment assignment. Treatment assignment was the independent variable of interest.||||0.0232
72344315|NCT04118595|144211632|SUPERIORITY|||||||0.13|||||||ANCOVA|||||||0.13
72344316|NCT04118595|144211633|SUPERIORITY|||||||0.41|||||||ANCOVA|||||||0.41
72344317|NCT04118595|144211634|SUPERIORITY|||||||0.08|||||||ANCOVA|||||||0.08
72344318|NCT04118595|144211635|SUPERIORITY|||||||0.64|||||||ANCOVA|||||||0.64
72344319|NCT04118595|144211636|SUPERIORITY|||||||0.57|||||||ANCOVA|||||||0.57
72344320|NCT04118595|144211637|SUPERIORITY|||||||0.43|||||||ANCOVA|||||||0.43
72344321|NCT04118595|144211638|SUPERIORITY|||||||0.19|||||||ANCOVA|||||||0.19
72344322|NCT04118595|144211639|SUPERIORITY|||||||0.15|||||||ANCOVA|||||||0.15
72344323|NCT04118595|144211640|SUPERIORITY|||||||0.04|||||||ANCOVA|||||||0.04
72344324|NCT04118595|144211641|SUPERIORITY|||||||0.36|||||||ANCOVA|||||||0.36
72344325|NCT03624127|144211649|SUPERIORITY||Odds Ratio (OR)|18.71|||<|0.0001|TWO_SIDED|95.0|9.51|36.81|||Cochran-Mantel-Haenszel|||||36.81|9.51|<0.0001
72344326|NCT03624127|144211650|SUPERIORITY||Odds Ratio (OR)|11.09|||<|0.0001|TWO_SIDED|95.0|6.49|18.95|||Cochran-Mantel-Haenszel|||||18.95|6.49|<0.0001
72344327|NCT03624127|144211651|SUPERIORITY||Odds Ratio (OR)|16.15|||<|0.0001|TWO_SIDED|95.0|6.91|37.72|||Cochran-Mantel-Haenszel|||||37.72|6.91|<0.0001
72344328|NCT03624127|144211651|SUPERIORITY||Odds Ratio (OR)|2.4||||0.0002|TWO_SIDED|95.0|1.51|3.6|||Cochran-Mantel-Haenszel|||||3.60|1.51|0.0002
72344329|NCT03624127|144211652|SUPERIORITY||Odds Ratio (OR)|31.3|||<|0.0001|TWO_SIDED|95.0|4.09|239.36|||Cochran-Mantel-Haenszel|||||239.36|4.09|<0.0001
72344330|NCT03624127|144211653|SUPERIORITY||Odds Ratio (OR)|4.52|||<|0.0001|TWO_SIDED|95.0|2.07|9.84|||Cochran-Mantel-Haenszel|||||9.84|2.07|<0.0001
72344331|NCT03624127|144211653|SUPERIORITY||Odds Ratio (OR)|39.54|||<|0.0001|TWO_SIDED|95.0|5.29|295.75|||Cochran-Mantel-Haenszel|||||295.75|5.29|<0.0001
72344332|NCT03624127|144211654|SUPERIORITY||Adjusted Mean Difference|-8.8|STANDARD_ERROR_OF_MEAN|2.0|<|0.0001|TWO_SIDED|95.0|-12.8|-4.9|||ANCOVA|||||-4.9|-12.8|<0.0001
72344333|NCT03624127|144211655|SUPERIORITY||Odds Ratio (OR)|13.67||||0.0013|TWO_SIDED|95.0|1.77|105.5|||Cochran-Mantel-Haenszel|||||105.50|1.77|0.0013
72344334|NCT03624127|144211655|SUPERIORITY||Odds Ratio (OR)|1.84||||0.1702|TWO_SIDED|95.0|0.76|4.42|||Cochran-Mantel-Haenszel|||||4.42|0.76|0.1702
72344335|NCT03624127|144211656|SUPERIORITY||Odds Ratio (OR)|6.04|||<|0.0001|TWO_SIDED|95.0|3.46|10.53|||Cochran-Mantel-Haenszel|||||10.53|3.46|<0.0001
72344336|NCT03624127|144211657|SUPERIORITY||Odds Ratio (OR)|2.84||||0.1049|TWO_SIDED|95.0|0.73|10.96|||Cochran-Mantel-Haenszel|||||10.96|0.73|0.1049
72344337|NCT03624127|144211658|SUPERIORITY||Odds Ratio (OR)|2.64|||<|0.0001|TWO_SIDED|95.0|1.78|3.91|||Cochran-Mantel-Haenszel|||||3.91|1.78|<0.0001
72344338|NCT03624127|144211659|SUPERIORITY||Odds Ratio (OR)|2.53|||<|0.0001|TWO_SIDED|95.0|1.7|3.78|||Cochran-Mantel-Haenszel|||||3.78|1.70|<0.0001
72344339|NCT03624127|144211660|SUPERIORITY||Odds Ratio (OR)|11.92|||<|0.0001|TWO_SIDED|95.0|6.69|21.25|||Cochran-Mantel-Haenszel|||||21.25|6.69|<0.0001
72344340|NCT03624127|144211660|SUPERIORITY||Odds Ratio (OR)|3.65|||<|0.0001|TWO_SIDED|95.0|2.21|6.04|||Cochran-Mantel-Haenszel|||||6.04|2.21|<0.0001
72344341|NCT03624127|144211661|SUPERIORITY||Odds Ratio (OR)|3.23|||<|0.0001|TWO_SIDED|95.0|2.16|4.83|||Cochran-Mantel-Haenszel|||||4.83|2.16|<0.0001
72344342|NCT03624127|144211662|SUPERIORITY||Odds Ratio (OR)|3.76|||<|0.0001|TWO_SIDED|95.0|2.53|5.6|||Cochran-Mantel-Haenszel|||||5.60|2.53|<0.0001
72344343|NCT03624127|144211663|SUPERIORITY||Odds Ratio (OR)|2.63|||<|0.0001|TWO_SIDED|95.0|1.71|4.05|||Cochran-Mantel-Haenszel|||||4.05|1.71|<0.0001
72344344|NCT03624127|144211664|SUPERIORITY||Odds Ratio (OR)|3.03|||<|0.0001|TWO_SIDED|95.0|1.96|4.69|||Cochran-Mantel-Haenszel|||||4.69|1.96|<0.0001
72344345|NCT03624127|144211665|SUPERIORITY||Odds Ratio (OR)|3.11|||<|0.0001|TWO_SIDED|95.0|2.06|4.69|||Cochran-Mantel-Haenszel|||||4.69|2.06|<0.0001
72344346|NCT03624127|144211666|SUPERIORITY||Odds Ratio (OR)|2.55||||0.0002|TWO_SIDED|95.0|1.55|4.19|||Cochran-Mantel-Haenszel|||||4.19|1.55|0.0002
72344347|NCT02262754|144211692|SUPERIORITY_OR_OTHER||Mean Difference (PF-06372865-Placebo)|0.16|||||TWO_SIDED|90.0|-0.28|0.6||||||An analysis of covariance (ANCOVA) model within an outlier robust Bayesian framework was applied. Baseline was included as a fixed effect. An informative N (-2.36, 0.542\^2) prior for the placebo effect was assumed. Non informative prior distributions were assumed for the rest of the model parameters. A last observation carried forward (LOCF) was used for missing data.||0.60|-0.28|
72344348|NCT02262754|144211692|SUPERIORITY_OR_OTHER||Mean Difference (PF-06372865-Naproxen)|0.42|||||TWO_SIDED|90.0|-0.02|0.87||||||An ANCOVA model within an outlier robust Bayesian framework was applied. Baseline was included as a fixed effect. An informative N (-2.36, 0.542\^2) prior for the placebo effect was assumed. Non informative prior distributions were assumed for the rest of the model parameters. A last observation carried forward LOCF was used for missing data.||0.87|-0.02|
72344349|NCT02262754|144211692|SUPERIORITY_OR_OTHER||Mean Difference (Naproxen-Placebo)|-0.26|||||TWO_SIDED|90.0|-0.7|0.18||||||An ANCOVA model within an outlier robust Bayesian framework was applied. Baseline was included as a fixed effect. An informative N (-2.36, 0.542\^2) prior for the placebo effect was assumed. Non informative prior distributions were assumed for the rest of the model parameters. A last observation carried forward LOCF was used for missing data.||0.18|-0.70|
72344350|NCT02262754|144211698|SUPERIORITY_OR_OTHER||LS Mean Difference (PF-06372865-Placebo)|-0.23|STANDARD_ERROR_OF_MEAN|0.32|||TWO_SIDED|90.0|-0.76|0.3||||||The ANCOVA model included treatment as fixed effects.||0.30|-0.76|
72344351|NCT02262754|144211698|SUPERIORITY_OR_OTHER||LS Mean Difference (Naproxen-Placebo)|0.12|STANDARD_ERROR_OF_MEAN|0.32|||TWO_SIDED|90.0|-0.41|0.65||||||The ANCOVA model included treatment as fixed effects.||0.65|-0.41|
72344352|NCT02262754|144211698|SUPERIORITY_OR_OTHER||LS Mean Difference(PF-06372865-Naproxen)|-0.35|STANDARD_ERROR_OF_MEAN|0.32|||TWO_SIDED|90.0|-0.87|0.17||||||The ANCOVA model included treatment as fixed effects.||0.17|-0.87|
72344353|NCT02262754|144211699|SUPERIORITY_OR_OTHER||LS Mean Difference (PF-06372865-Placebo)|0.08|STANDARD_ERROR_OF_MEAN|0.17|||TWO_SIDED|90.0|-0.2|0.36||||||Week 1: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline was included as a covariate.||0.36|-0.20|
72344354|NCT02262754|144211699|SUPERIORITY_OR_OTHER||LS Mean Difference (Naproxen-Placebo)|-0.2|STANDARD_ERROR_OF_MEAN|0.17|||TWO_SIDED|90.0|-0.48|0.07||||||Week 1: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline was included as a covariate.||0.07|-0.48|
72344355|NCT02262754|144211699|SUPERIORITY_OR_OTHER||LS Mean Difference(PF-06372865-Naproxen)|0.28|STANDARD_ERROR_OF_MEAN|0.17|||TWO_SIDED|90.0|0.01|0.56||||||Week 1: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline was included as a covariate.||0.56|0.01|
72344356|NCT02262754|144211699|SUPERIORITY_OR_OTHER||LS Mean Difference (PF-06372865-Placebo)|-0.05|STANDARD_ERROR_OF_MEAN|0.24|||TWO_SIDED|90.0|-0.43|0.34||||||Week 2: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline was included as a covariate.||0.34|-0.43|
72344357|NCT02262754|144211699|SUPERIORITY_OR_OTHER||LS Mean Difference (Naproxen-Placebo)|-0.24|STANDARD_ERROR_OF_MEAN|0.23|||TWO_SIDED|90.0|-0.62|0.15||||||Week 2: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline was included as a covariate.||0.15|-0.62|
72428740|NCT04147260|144368586|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|-1.96|STANDARD_ERROR_OF_MEAN|4.048||0.63|TWO_SIDED|90.0|-10.14|6.21||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||6.21|-10.14|0.630
72428741|NCT04147260|144368586|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|5.482||1|TWO_SIDED|90.0|-11.07|11.07||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||11.07|-11.07|1.000
72428742|NCT04147260|144368586|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|-1.44|STANDARD_ERROR_OF_MEAN|4.518||0.751|TWO_SIDED|90.0|-10.55|7.66||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||7.66|-10.55|0.751
72428743|NCT04147260|144368586|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|1.68|STANDARD_ERROR_OF_MEAN|3.894||0.669|TWO_SIDED|90.0|-6.17|9.52||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||9.52|-6.17|0.669
72428744|NCT04147260|144368586|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|-3.12|STANDARD_ERROR_OF_MEAN|5.123||0.546|TWO_SIDED|90.0|-13.44|7.21||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||7.21|-13.44|0.546
72428745|NCT04147260|144368587|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|-12.45|STANDARD_ERROR_OF_MEAN|11.385||0.281|TWO_SIDED|90.0|-35.44|10.54||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||10.54|-35.44|0.281
72428746|NCT04147260|144368587|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|-16.14|STANDARD_ERROR_OF_MEAN|9.35||0.092|TWO_SIDED|90.0|-35.02|2.74||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||2.74|-35.02|0.092
72428747|NCT04147260|144368587|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|3.69|STANDARD_ERROR_OF_MEAN|12.662||0.772|TWO_SIDED|90.0|-21.88|29.27||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||29.27|-21.88|0.772
72428748|NCT04147260|144368587|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|-8.21|STANDARD_ERROR_OF_MEAN|13.255||0.539|TWO_SIDED|90.0|-34.93|18.5||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||18.50|-34.93|0.539
72428749|NCT04147260|144368587|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|-4.71|STANDARD_ERROR_OF_MEAN|11.424||0.682|TWO_SIDED|90.0|-27.74|18.31||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||18.31|-27.74|0.682
72428750|NCT04147260|144368587|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|-3.5|STANDARD_ERROR_OF_MEAN|15.03||0.817|TWO_SIDED|90.0|-33.79|26.79||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||26.79|-33.79|0.817
72428751|NCT04147260|144368588|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|-0.73|STANDARD_ERROR_OF_MEAN|5.327||0.891|TWO_SIDED|90.0|-11.49|10.02||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||10.02|-11.49|0.891
72428752|NCT04147260|144368588|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|-3.59|STANDARD_ERROR_OF_MEAN|4.375||0.417|TWO_SIDED|90.0|-12.42|5.25||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||5.25|-12.42|0.417
72428753|NCT04147260|144368588|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|2.85|STANDARD_ERROR_OF_MEAN|5.925||0.633|TWO_SIDED|90.0|-9.11|14.82||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||14.82|-9.11|0.633
72344358|NCT02262754|144211699|SUPERIORITY_OR_OTHER||LS Mean Difference(PF-06372865-Naproxen)|0.19|STANDARD_ERROR_OF_MEAN|0.23|||TWO_SIDED|90.0|-0.19|0.58||||||Week 2: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline was included as a covariate.||0.58|-0.19|
72428754|NCT04147260|144368588|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|6.79|STANDARD_ERROR_OF_MEAN|4.384||0.129|TWO_SIDED|90.0|-2.05|15.62||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||15.62|-2.05|0.129
72344359|NCT02262754|144211699|SUPERIORITY_OR_OTHER||LS Mean Difference (PF-06372865-Placebo)|0.03|STANDARD_ERROR_OF_MEAN|0.26|||TWO_SIDED|90.0|-0.39|0.45||||||Week 3: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline was included as a covariate.||0.45|-0.39|
72344360|NCT02262754|144211699|SUPERIORITY_OR_OTHER||LS Mean Difference (Naproxen-Placebo)|-0.27|STANDARD_ERROR_OF_MEAN|0.26|||TWO_SIDED|90.0|-0.69|0.16||||||Week 3: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline was included as a covariate.||0.16|-0.69|
72344361|NCT02262754|144211699|SUPERIORITY_OR_OTHER||LS Mean Difference(PF-06372865-Naproxen)|0.3|STANDARD_ERROR_OF_MEAN|0.25||||90.0|-0.12|0.71||||||Week 3: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline was included as a covariate.||0.71|-0.12|
72344362|NCT02262754|144211699|SUPERIORITY_OR_OTHER||LS Mean Difference (PF-06372865-Placebo)|0.07|STANDARD_ERROR_OF_MEAN|0.29|||TWO_SIDED|90.0|-0.4|0.55||||||Week 4: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline was included as a covariate.||0.55|-0.40|
72344363|NCT02262754|144211699|SUPERIORITY_OR_OTHER||LS Mean Difference (Naproxen-Placebo)|-0.37|STANDARD_ERROR_OF_MEAN|0.29|||TWO_SIDED|90.0|-0.84|0.11||||||Week 4: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline was included as a covariate.||0.11|-0.84|
72344364|NCT02262754|144211699|SUPERIORITY_OR_OTHER||LS Mean Difference(PF-06372865-Naproxen)|0.44|STANDARD_ERROR_OF_MEAN|0.28|||TWO_SIDED|90.0|-0.03|0.91||||||Week 4: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline was included as a covariate.||0.91|-0.03|
72344365|NCT02262754|144211700|SUPERIORITY_OR_OTHER||LS Mean Difference (PF-06372865-Placebo)|0.03|STANDARD_ERROR_OF_MEAN|0.03|||TWO_SIDED|90.0|-0.03|0.08||||||Week 1: The mixed effect repeated measures model includes treatment, week and the week\*treatment interaction as fixed effects, week repeated within each subject as a repeated effect and log baseline as a response. LS Mean Difference and 90 percent confidence interval was calculated from log values.||0.08|-0.03|
72428755|NCT04147260|144368588|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|2.29|STANDARD_ERROR_OF_MEAN|3.778||0.548|TWO_SIDED|90.0|-5.33|9.9||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||9.90|-5.33|0.548
72344366|NCT02262754|144211700|SUPERIORITY_OR_OTHER||LS Mean Difference (Naproxen-Placebo)|-0.04|STANDARD_ERROR_OF_MEAN|0.03|||TWO_SIDED|90.0|-0.09|0.02||||||Week 1: The mixed effect repeated measures model includes treatment, week and the week\*treatment interaction as fixed effects, week repeated within each subject as a repeated effect and log baseline as a response. LS Mean Difference and 90 percent confidence interval was calculated from log values.||0.02|-0.09|
72344367|NCT02262754|144211700|SUPERIORITY_OR_OTHER||LS Mean Difference(PF-06372865-Naproxen)|0.06|STANDARD_ERROR_OF_MEAN|0.03|||TWO_SIDED|90.0|0.01|0.12||||||Week 1: The mixed effect repeated measures model includes treatment, week and the week\*treatment interaction as fixed effects, week repeated within each subject as a repeated effect and log baseline as a response. LS Mean Difference and 90 percent confidence interval was calculated from log values.||0.12|0.01|
72344368|NCT02262754|144211700|SUPERIORITY_OR_OTHER||LS Mean Difference (PF-06372865-Placebo)|0.01|STANDARD_ERROR_OF_MEAN|0.06|||TWO_SIDED|90.0|-0.09|0.1||||||Week 2: The mixed effect repeated measures model includes treatment, week and the week\*treatment interaction as fixed effects, week repeated within each subject as a repeated effect and log baseline as a response. LS Mean Difference and 90 percent confidence interval was calculated from log values.||0.10|-0.09|
72344369|NCT02262754|144211700|SUPERIORITY_OR_OTHER||LS Mean Difference (Naproxen-Placebo)|-0.05|STANDARD_ERROR_OF_MEAN|0.06|||TWO_SIDED|90.0|-0.15|0.05||||||Week 2: The mixed effect repeated measures model includes treatment, week and the week\*treatment interaction as fixed effects, week repeated within each subject as a repeated effect and log baseline as a response. LS Mean Difference and 90 percent confidence interval was calculated from log values.||0.05|-0.15|
72344370|NCT02262754|144211700|SUPERIORITY_OR_OTHER||LS Mean Difference(PF-06372865-Naproxen)|0.06|STANDARD_ERROR_OF_MEAN|0.06|||TWO_SIDED|90.0|-0.04|0.15||||||Week 2: The mixed effect repeated measures model includes treatment, week and the week\*treatment interaction as fixed effects, week repeated within each subject as a repeated effect and log baseline as a response. LS Mean Difference and 90 percent confidence interval was calculated from log values.||0.15|-0.04|
72344371|NCT02262754|144211700|SUPERIORITY_OR_OTHER||LS Mean Difference (PF-06372865-Placebo)|0.0|STANDARD_ERROR_OF_MEAN|0.07|||TWO_SIDED|90.0|-0.12|0.12||||||Week 3: The mixed effect repeated measures model includes treatment, week and the week\*treatment interaction as fixed effects, week repeated within each subject as a repeated effect and log baseline as a response. LS Mean Difference and 90 percent confidence interval was calculated from log values.||0.12|-0.12|
72344372|NCT02262754|144211700|SUPERIORITY_OR_OTHER||LS Mean Difference (Naproxen-Placebo)|-0.05|STANDARD_ERROR_OF_MEAN|0.07|||TWO_SIDED|90.0|-0.16|0.07||||||Week 3: The mixed effect repeated measures model includes treatment, week and the week\*treatment interaction as fixed effects, week repeated within each subject as a repeated effect and log baseline as a response. LS Mean Difference and 90 percent confidence interval was calculated from log values.||0.07|-0.16|
72344373|NCT02262754|144211700|SUPERIORITY_OR_OTHER||LS Mean Difference(PF-06372865-Naproxen)|0.05|STANDARD_ERROR_OF_MEAN|0.07|||TWO_SIDED|90.0|-0.07|0.16||||||Week 3: The mixed effect repeated measures model includes treatment, week and the week\*treatment interaction as fixed effects, week repeated within each subject as a repeated effect and log baseline as a response. LS Mean Difference and 90 percent confidence interval was calculated from log values.||0.16|-0.07|
72344374|NCT02262754|144211700|SUPERIORITY_OR_OTHER||LS Mean Difference (PF-06372865-Placebo)|-0.01|STANDARD_ERROR_OF_MEAN|0.09|||TWO_SIDED|90.0|-0.16|0.14||||||Week 4: The mixed effect repeated measures model includes treatment, week and the week\*treatment interaction as fixed effects, week repeated within each subject as a repeated effect and log baseline as a response. LS Mean Difference and 90 percent confidence interval was calculated from log values.||0.14|-0.16|
72344375|NCT02262754|144211700|SUPERIORITY_OR_OTHER||LS Mean Difference (Naproxen-Placebo)|-0.1|STANDARD_ERROR_OF_MEAN|0.09|||TWO_SIDED|90.0|-0.24|0.05||||||Week 4: The mixed effect repeated measures model includes treatment, week and the week\*treatment interaction as fixed effects, week repeated within each subject as a repeated effect and log baseline as a response. LS Mean Difference and 90 percent confidence interval was calculated from log values.||0.05|-0.24|
72344376|NCT02262754|144211700|SUPERIORITY_OR_OTHER||LS Mean Difference(PF-06372865-Naproxen)|0.09|STANDARD_ERROR_OF_MEAN|0.09|||TWO_SIDED|90.0|-0.05|0.23||||||Week 4: The mixed effect repeated measures model includes treatment, week and the week\*treatment interaction as fixed effects, week repeated within each subject as a repeated effect and log baseline as a response. LS Mean Difference and 90 percent confidence interval was calculated from log values.||0.23|-0.05|
72344377|NCT02262754|144211701|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.97|||||TWO_SIDED|90.0|0.54|1.73||||||\>=30 percent sustained response rates: Odds Ratios based on a logistic regression model included treatment as a fixed effect and baseline as a covariate.||1.73|0.54|
72344378|NCT02262754|144211701|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.43|||||TWO_SIDED|90.0|0.81|2.51||||||\>=30 percent sustained response rates: Odds Ratios based on a logistic regression model included treatment as a fixed effect and baseline as a covariate.||2.51|0.81|
72344379|NCT02262754|144211701|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.68|||||TWO_SIDED|90.0|0.39|1.2||||||\>=30 percent sustained response rates: Odds Ratios based on a logistic regression model included treatment as a fixed effect and baseline as a covariate.||1.20|0.39|
72344380|NCT02262754|144211701|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.81|||||TWO_SIDED|90.0|0.37|1.81||||||\>=50 percent sustained response rates: Odds Ratios based on a logistic regression model included treatment as a fixed effect and baseline as a covariate.||1.81|0.37|
72428756|NCT04147260|144368588|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|4.5|STANDARD_ERROR_OF_MEAN|4.97||0.37|TWO_SIDED|90.0|-5.51|14.52||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||14.52|-5.51|0.370
72428757|NCT04147260|144368589|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|-9.3|STANDARD_ERROR_OF_MEAN|10.379||0.375|TWO_SIDED|90.0|-30.26|11.66||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||11.66|-30.26|0.375
72344381|NCT02262754|144211701|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.11|||||TWO_SIDED|90.0|0.53|2.35||||||\>=50 percent sustained response rates: Odds Ratios based on a logistic regression model included treatment as a fixed effect and baseline as a covariate.||2.35|0.53|
72344382|NCT02262754|144211701|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.73|||||TWO_SIDED|90.0|0.33|1.6||||||\>=50 percent sustained response rates: Odds Ratios based on a logistic regression model included treatment as a fixed effect and baseline as a covariate.||1.60|0.33|
72344383|NCT02262754|144211707|SUPERIORITY_OR_OTHER||LS Mean Difference (PF-06372865-Placebo)|-0.18|STANDARD_ERROR_OF_MEAN|0.53|||TWO_SIDED|90.0|-1.06|0.7||||||Week 1: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline was included as a covariate.||0.70|-1.06|
72344384|NCT02262754|144211707|SUPERIORITY_OR_OTHER||LS Mean Difference (Naproxen-Placebo)|-0.91|STANDARD_ERROR_OF_MEAN|0.53|||TWO_SIDED|90.0|-1.8|-0.03||||||Week 1: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline was included as a covariate.||-0.03|-1.80|
72344385|NCT02262754|144211707|SUPERIORITY_OR_OTHER||LS Mean Difference(PF-06372865-Naproxen)|0.73|STANDARD_ERROR_OF_MEAN|0.53|||TWO_SIDED|90.0|-0.15|1.61||||||Week 1: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline was included as a covariate.||1.61|-0.15|
72344386|NCT02262754|144211707|SUPERIORITY_OR_OTHER||LS Mean Difference (PF-06372865-Placebo)|-0.7|STANDARD_ERROR_OF_MEAN|0.6|||TWO_SIDED|90.0|-1.69|0.29||||||Week 2: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline was included as a covariate.||0.29|-1.69|
72344387|NCT02262754|144211707|SUPERIORITY_OR_OTHER||LS Mean Difference (Naproxen-Placebo)|-1.11|STANDARD_ERROR_OF_MEAN|0.6|||TWO_SIDED|90.0|-2.11|-0.11||||||Week 2: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline was included as a covariate.||-0.11|-2.11|
72344388|NCT02262754|144211707|SUPERIORITY_OR_OTHER||LS Mean Difference(PF-06372865-Naproxen)|0.41|STANDARD_ERROR_OF_MEAN|0.59|||TWO_SIDED|90.0|-0.57|1.39||||||Week 2: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline was included as a covariate.||1.39|-0.57|
72344389|NCT02262754|144211707|SUPERIORITY_OR_OTHER||LS Mean Difference (PF-06372865-Placebo)|-0.41|STANDARD_ERROR_OF_MEAN|0.61|||TWO_SIDED|90.0|-1.42|0.6||||||Week 3: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline was included as a covariate.||0.60|-1.42|
72344390|NCT02262754|144211707|SUPERIORITY_OR_OTHER||LS Mean Difference (Naproxen-Placebo)|-1.27|STANDARD_ERROR_OF_MEAN|0.61|||TWO_SIDED|90.0|-2.28|-0.27||||||Week 3: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline was included as a covariate.||-0.27|-2.28|
72344391|NCT02262754|144211707|SUPERIORITY_OR_OTHER||LS Mean Difference(PF-06372865-Naproxen)|0.86|STANDARD_ERROR_OF_MEAN|0.6|||TWO_SIDED|90.0|-0.12|1.85||||||Week 3: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline was included as a covariate.||1.85|-0.12|
72344392|NCT02262754|144211708|SUPERIORITY_OR_OTHER||Mean Difference (PF-06372865-Placebo)|-0.64|||||TWO_SIDED|90.0|-1.63|0.35||||||Week 4: An ANCOVA model within an outlier robust Bayesian framework was applied. Baseline was included as a fixed effect. An informative N (-3.28, 1.19\^2) prior for the placebo effect was assumed. Non informative prior distributions were assumed for the rest of the model parameters. LOCF was used for missing data.||0.35|-1.63|
72344393|NCT02262754|144211708|SUPERIORITY_OR_OTHER||Mean Difference (Naproxen-Placebo)|-1.43|||||TWO_SIDED|90.0|-2.4|-0.45||||||Week 4: An ANCOVA model within an outlier robust Bayesian framework was applied. Baseline was included as a fixed effect. An informative N (-3.28, 1.19\^2) prior for the placebo effect was assumed. Non informative prior distributions were assumed for the rest of the model parameters. LOCF was used for missing data.||-0.45|-2.40|
72344394|NCT02262754|144211708|SUPERIORITY_OR_OTHER||Mean Difference (PF-06372865-Naproxen)|0.79|||||TWO_SIDED|90.0|-0.22|1.8||||||Week 4: An ANCOVA model within an outlier robust Bayesian framework was applied. Baseline was included as a fixed effect. An informative N (-3.28, 1.19\^2) prior for the placebo effect was assumed. Non informative prior distributions were assumed for the rest of the model parameters. LOCF was used for missing data.||1.80|-0.22|
72344395|NCT02262754|144211709|SUPERIORITY_OR_OTHER||LS Mean Difference (PF-06372865-Placebo)|-0.37|STANDARD_ERROR_OF_MEAN|0.7|||TWO_SIDED|90.0|-1.52|0.78||||||Total recall score at Week 2: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline (recordings on Day 1) was included as a covariate. Unplanned readings were excluded from the analysis.||0.78|-1.52|
72344396|NCT02262754|144211709|SUPERIORITY_OR_OTHER||LS Mean Difference (Naproxen-Placebo)|-0.95|STANDARD_ERROR_OF_MEAN|0.7|||TWO_SIDED|90.0|-2.1|0.2||||||Total recall score at Week 2: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline (recordings on Day 1) was included as a covariate. Unplanned readings were excluded from the analysis.||0.20|-2.10|
72344397|NCT02262754|144211709|SUPERIORITY_OR_OTHER||LS Mean Difference(PF-06372865-Naproxen)|0.58|STANDARD_ERROR_OF_MEAN|0.68|||TWO_SIDED|90.0|-0.56|1.71||||||Total recall score at Week 2: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline (recordings on Day 1) was included as a covariate. Unplanned readings were excluded from the analysis.||1.71|-0.56|
72344398|NCT02262754|144211709|SUPERIORITY_OR_OTHER||LS Mean Difference (PF-06372865-Placebo)|-1.02|STANDARD_ERROR_OF_MEAN|0.63|||TWO_SIDED|90.0|-2.06|0.02||||||Total Recall score at Week 4: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline (recordings on Day 1) was included as a covariate. Unplanned readings were excluded from the analysis.||0.02|-2.06|
72344399|NCT02262754|144211709|SUPERIORITY_OR_OTHER||LS Mean Difference (Naproxen-Placebo)|-1.21|STANDARD_ERROR_OF_MEAN|0.63|||TWO_SIDED|90.0|-2.25|-0.17||||||Total Recall score at Week 4: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline (recordings on Day 1) was included as a covariate. Unplanned readings were excluded from the analysis.||-0.17|-2.25|
72344400|NCT02262754|144211709|SUPERIORITY_OR_OTHER||LS Mean Difference(PF-06372865-Naproxen)|0.19|STANDARD_ERROR_OF_MEAN|0.61|||TWO_SIDED|90.0|-0.82|1.19||||||Total Recall score at Week 4: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline (recordings on Day 1) was included as a covariate. Unplanned readings were excluded from the analysis.||1.19|-0.82|
72344401|NCT02262754|144211709|SUPERIORITY_OR_OTHER||LS Mean Difference (PF-06372865-Placebo)|-0.77|STANDARD_ERROR_OF_MEAN|0.38|||TWO_SIDED|90.0|-1.39|-0.15||||||Delayed recall score at Week 2: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline (recordings on Day 1) was included as a covariate. Unplanned readings were excluded from the analysis.||-0.15|-1.39|
72344402|NCT02262754|144211709|SUPERIORITY_OR_OTHER||LS Mean Difference (Naproxen-Placebo)|-0.17|STANDARD_ERROR_OF_MEAN|0.38|||TWO_SIDED|90.0|-0.8|0.45||||||Delayed recall score at Week 2: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline (recordings on Day 1) was included as a covariate. Unplanned readings were excluded from the analysis.||0.45|-0.80|
72344403|NCT02262754|144211709|SUPERIORITY_OR_OTHER||LS Mean Difference(PF-06372865-Naproxen)|-0.6|STANDARD_ERROR_OF_MEAN|0.37|||TWO_SIDED|90.0|-1.21|0.02||||||Delayed recall score at Week 2: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline (recordings on Day 1) was included as a covariate. Unplanned readings were excluded from the analysis.||0.02|-1.21|
72344404|NCT02262754|144211709|SUPERIORITY_OR_OTHER||LS Mean Difference (PF-06372865-Placebo)|-0.85|STANDARD_ERROR_OF_MEAN|0.34|||TWO_SIDED|90.0|-1.42|-0.28||||||Delayed recall score at Week 4: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline (recordings on Day 1) was included as a covariate. Unplanned readings were excluded from the analysis.||-0.28|-1.42|
72344405|NCT02262754|144211709|SUPERIORITY_OR_OTHER||LS Mean Difference (Naproxen-Placebo)|-0.11|STANDARD_ERROR_OF_MEAN|0.34|||TWO_SIDED|90.0|-0.67|0.46||||||Delayed recall score at Week 4: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline (recordings on Day 1) was included as a covariate. Unplanned readings were excluded from the analysis.||0.46|-0.67|
72344406|NCT02262754|144211709|SUPERIORITY_OR_OTHER||LS Mean Difference(PF-06372865-Naproxen)|-0.74|STANDARD_ERROR_OF_MEAN|0.33|||TWO_SIDED|90.0|-1.29|-0.2||||||Delayed recall score at Week 4: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline (recordings on Day 1) was included as a covariate. Unplanned readings were excluded from the analysis.||-0.20|-1.29|
72344407|NCT02262754|144211710|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.98|||||TWO_SIDED|90.0|0.61|1.58||||||A repeated measures logistic regression model included treatment and week as fixed effects and LBPI baseline as a covariate. Participant was included as a repeated effect.||1.58|0.61|
72344408|NCT02262754|144211710|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.04|||||TWO_SIDED|90.0|1.33|3.14||||||A repeated measures logistic regression model included treatment and week as fixed effects and LBPI baseline as a covariate. Participant was included as a repeated effect.||3.14|1.33|
72344409|NCT02262754|144211710|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.48|||||TWO_SIDED|90.0|0.31|0.74||||||A repeated measures logistic regression model included treatment and week as fixed effects and LBPI baseline as a covariate. Participant was included as a repeated effect.||0.74|0.31|
72344410|NCT02262754|144211711|SUPERIORITY_OR_OTHER||LS Mean Difference (PF-06372865-Placebo)|0.01|STANDARD_ERROR_OF_MEAN|0.12|||TWO_SIDED|90.0|-0.19|0.2||||||Week 1: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline (recordings on Day 1) was included as a covariate.||0.20|-0.19|
72344411|NCT02262754|144211711|SUPERIORITY_OR_OTHER||LS Mean Difference (Naproxen-Placebo)|-0.14|STANDARD_ERROR_OF_MEAN|0.12|||TWO_SIDED|90.0|-0.34|0.05||||||Week 1: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline (recordings on Day 1) was included as a covariate.||0.05|-0.34|
72428758|NCT04147260|144368589|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|-11.49|STANDARD_ERROR_OF_MEAN|8.524||0.185|TWO_SIDED|90.0|-28.7|5.73||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||5.73|-28.70|0.185
72344412|NCT02262754|144211711|SUPERIORITY_OR_OTHER||LS Mean Difference(PF-06372865-Naproxen)|0.15|STANDARD_ERROR_OF_MEAN|0.12|||TWO_SIDED|90.0|-0.05|0.35||||||Week 1: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline (recordings on Day 1) was included as a covariate.||0.35|-0.05|
72344413|NCT02262754|144211711|SUPERIORITY_OR_OTHER||LS Mean Difference (PF-06372865-Placebo)|-0.04|STANDARD_ERROR_OF_MEAN|0.13|||TWO_SIDED|90.0|-0.26|0.18||||||Week 2: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline (recordings on Day 1) was included as a covariate.||0.18|-0.26|
72344414|NCT02262754|144211711|SUPERIORITY_OR_OTHER||LS Mean Difference (Naproxen-Placebo)|-0.15|STANDARD_ERROR_OF_MEAN|0.13|||TWO_SIDED|90.0|-0.37|0.07||||||Week 2: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline (recordings on Day 1) was included as a covariate.||0.07|-0.37|
72344415|NCT02262754|144211711|SUPERIORITY_OR_OTHER||LS Mean Difference(PF-06372865-Naproxen)|0.11|STANDARD_ERROR_OF_MEAN|0.13|||TWO_SIDED|90.0|-0.1|0.33||||||Week 2: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline (recordings on Day 1) was included as a covariate.||0.33|-0.10|
72344416|NCT02262754|144211711|SUPERIORITY_OR_OTHER||LS Mean Difference (PF-06372865-Placebo)|0.15|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|90.0|-0.09|0.38||||||Week 3: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline (recordings on Day 1) was included as a covariate.||0.38|-0.09|
72344417|NCT02262754|144211711|SUPERIORITY_OR_OTHER||LS Mean Difference (Naproxen-Placebo)|0.02|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|90.0|-0.21|0.25||||||Week 3: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline (recordings on Day 1) was included as a covariate.||0.25|-0.21|
72344418|NCT02262754|144211711|SUPERIORITY_OR_OTHER||LS Mean Difference(PF-06372865-Naproxen)|0.13|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|90.0|-0.1|0.36||||||Week 3: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline (recordings on Day 1) was included as a covariate.||0.36|-0.10|
72344419|NCT02262754|144211711|SUPERIORITY_OR_OTHER||LS Mean Difference (PF-06372865-Placebo)|0.12|STANDARD_ERROR_OF_MEAN|0.15|||TWO_SIDED|90.0|-0.13|0.38||||||Week 4: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline (recordings on Day 1) was included as a covariate.||0.38|-0.13|
72344420|NCT02262754|144211711|SUPERIORITY_OR_OTHER||LS Mean Difference (Naproxen-Placebo)|-0.21|STANDARD_ERROR_OF_MEAN|0.15|||TWO_SIDED|90.0|-0.46|0.05||||||Week 4: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline (recordings on Day 1) was included as a covariate.||0.05|-0.46|
72344421|NCT02262754|144211711|SUPERIORITY_OR_OTHER||LS Mean Difference(PF-06372865-Naproxen)|0.33|STANDARD_ERROR_OF_MEAN|0.15|||TWO_SIDED|90.0|0.08|0.58||||||Week 4: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline (recordings on Day 1) was included as a covariate.||0.58|0.08|
72344422|NCT02262754|144211712|SUPERIORITY_OR_OTHER||LS Mean Difference (PF-06372865-Placebo)|-0.17|STANDARD_ERROR_OF_MEAN|0.15|||TWO_SIDED|90.0|-0.42|0.08||||||Week 1: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect.||0.08|-0.42|
72344423|NCT02262754|144211712|SUPERIORITY_OR_OTHER||LS Mean Difference (Naproxen-Placebo)|-0.37|STANDARD_ERROR_OF_MEAN|0.15|||TWO_SIDED|90.0|-0.62|-0.12||||||Week 1: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect.||-0.12|-0.62|
72344424|NCT02262754|144211712|SUPERIORITY_OR_OTHER||LS Mean Difference(PF-06372865-Naproxen)|0.2|STANDARD_ERROR_OF_MEAN|0.15|||TWO_SIDED|90.0|-0.05|0.45||||||Week 1: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect.||0.45|-0.05|
72344425|NCT02262754|144211712|SUPERIORITY_OR_OTHER||LS Mean Difference (PF-06372865-Placebo)|-0.08|STANDARD_ERROR_OF_MEAN|0.18|||TWO_SIDED|90.0|-0.38|0.21||||||Week 2: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect.||0.21|-0.38|
72344426|NCT02262754|144211712|SUPERIORITY_OR_OTHER||LS Mean Difference (Naproxen-Placebo)|-0.29|STANDARD_ERROR_OF_MEAN|0.18|||TWO_SIDED|90.0|-0.58|0.01||||||Week 2: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect.||0.01|-0.58|
72344427|NCT02262754|144211712|SUPERIORITY_OR_OTHER||LS Mean Difference(PF-06372865-Naproxen)|0.2|STANDARD_ERROR_OF_MEAN|0.18|||TWO_SIDED|90.0|-0.09|0.49||||||Week 2: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect.||0.49|-0.09|
72344428|NCT02262754|144211712|SUPERIORITY_OR_OTHER||LS Mean Difference (PF-06372865-Placebo)|-0.07|STANDARD_ERROR_OF_MEAN|0.17|||TWO_SIDED|90.0|-0.36|0.21||||||Week 3: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect.||0.21|-0.36|
72344429|NCT02262754|144211712|SUPERIORITY_OR_OTHER||LS Mean Difference (Naproxen-Placebo)|-0.38|STANDARD_ERROR_OF_MEAN|0.17|||TWO_SIDED|90.0|-0.67|-0.1||||||Week 3: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect.||-0.10|-0.67|
72344430|NCT02262754|144211712|SUPERIORITY_OR_OTHER||LS Mean Difference(PF-06372865-Naproxen)|0.31|STANDARD_ERROR_OF_MEAN|0.17|||TWO_SIDED|90.0|0.03|0.59||||||Week 3: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect.||0.59|0.03|
72344431|NCT02262754|144211712|SUPERIORITY_OR_OTHER||LS Mean Difference (PF-06372865-Placebo)|-0.11|STANDARD_ERROR_OF_MEAN|0.19|||TWO_SIDED|90.0|-0.42|0.21||||||Week 4: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect.||0.21|-0.42|
72344432|NCT02262754|144211712|SUPERIORITY_OR_OTHER||LS Mean Difference (Naproxen-Placebo)|-0.43|STANDARD_ERROR_OF_MEAN|0.19|||TWO_SIDED|90.0|-0.75|-0.12||||||Week 4: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect.||-0.12|-0.75|
72344433|NCT02262754|144211712|SUPERIORITY_OR_OTHER||LS Mean Difference(PF-06372865-Naproxen)|0.33|STANDARD_ERROR_OF_MEAN|0.19|||TWO_SIDED|90.0|0.02|0.63||||||Week 4: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect.||0.63|0.02|
72344434|NCT02262754|144211713|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.85|||||TWO_SIDED|90.0|0.46|1.56||||||Odds Ratios were based on a logistic regression model and included treatment as a fixed effect.||1.56|0.46|
72344435|NCT02262754|144211713|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.43|||||TWO_SIDED|90.0|0.23|0.81||||||Odds Ratios were based on a logistic regression model and included treatment as a fixed effect.||0.81|0.23|
72344436|NCT02262754|144211713|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.97|||||TWO_SIDED|90.0|1.06|3.65||||||Odds Ratios were based on a logistic regression model and included treatment as a fixed effect.||3.65|1.06|
72370150|NCT00202878|144250659|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.912||||0.016|TWO_SIDED|95.0|0.847|0.983|||Cox proportional hazard model|Covariates of the stratification factors (EARLY ACS trial, chronic prescription lipid-lowering experience, and high-risk ACS diagnosis) and treatment.|Model includes events from randomization to last study visit.|||0.983|0.847|0.016
72370151|NCT00202878|144250660|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.945||||0.035|TWO_SIDED|95.0|0.897|0.996|||Cox proportional hazard model|Covariates of the stratification factors (EARLY ACS trial, chronic prescription lipid-lowering experience, and high-risk ACS diagnosis) and treatment|Model includes events from randomization to last study visit.|||0.996|0.897|0.035
72344437|NCT00006400|144211716|SUPERIORITY|The primary analysis was done using an intention-to-treat principle.||||||0.21||||||The spleen endpoint was to be tested at an overall alpha = 0.04. Originally there was a second primary outcome to be tested at alpha = 0.01, but this outcome was dropped.|Fisher Exact|||The primary analysis compared the frequency of worsening spleen function (from normal to decreased or absent, or decreased to absent) and not worsening (from decreased to decreased, normal to normal, or decreased to normal) as measured by splenic uptake on a technetium-99m (99mTc) sulfur colloid liver-spleen scan. Children with missing data or absent spleen function at baseline were excluded from the analysis (26 subjects from hydroxyurea and 23 subjects from placebo group were excluded).||||0.21
72344438|NCT00006400|144211717|SUPERIORITY|||||||0.93||||||This was originally a second primary outcome to be tested at alpha = 0.01, but was later dropped from the protocol. We analyzed the available data.|ANOVA|||The change from baseline to exit as measured by DTPA GFR were compared between treatment groups.||||0.93
72344439|NCT00006400|144211718|SUPERIORITY|||||||0.43||||||All secondary outcomes were tested at alpha=0.01|ANOVA|||The change from baseline to exit as measured by GFR (calculated using Shwartz formula) were compared between treatment groups.||||0.43
72344440|NCT00006400|144211719|SUPERIORITY|||||||0.48||||||All secondary outcomes were to be tested at alpha = 0.01|ANOVA|||The change in GFR from baseline to exit were compared between treatment groups. GFR was calculated using new Schwartz formula.||||0.48
72344441|NCT02577016|144211733|SUPERIORITY||Difference in least squares means|-0.83|||<|0.001|TWO_SIDED|95.0|-1.05|-0.62|||Constrained longitudinal data analysis|Based on a cLDA model with the terms listed above.||||-0.62|-1.05|<0.001
72344442|NCT02577016|144211736|SUPERIORITY||Difference in least squares means|-42.5|||<|0.001|TWO_SIDED|95.0|-53.7|-31.2|||Constrained longitudinal data analysis|Based on a cLDA model with the terms listed above.||||-31.2|-53.7|<0.001
72344443|NCT02577016|144211737|SUPERIORITY||Difference in least squares means|-67.0|||<|0.001|TWO_SIDED|95.0|-84.0|-50.0|||Constrained longitudinal data analysis|Based on a cLDA model with the terms listed above.||||-50.0|-84.0|<0.001
72344444|NCT02577016|144211738|SUPERIORITY||Difference in least squares means|-11.2|||<|0.001|TWO_SIDED|95.0|-17.2|-5.2|||Constrained longitudinal data analysis|Based on a cLDA model with the terms listed above.||||-5.2|-17.2|<0.001
72344445|NCT02126839|144211739|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|25.02|STANDARD_ERROR_OF_MEAN|4.52|<|0.0001|TWO_SIDED|95.0|16.1|33.94|||mixed model repeated measures analysis|Fixed effects of treatment group, treatment day, and study day by treatment interaction, with baseline measured at each study day as a covariate.||||33.94|16.10|<0.0001
72344446|NCT02126839|144211740|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|76.33|STANDARD_ERROR_OF_MEAN|14.47|<|0.0001|TWO_SIDED|95.0|47.76|104.91|||mixed model repeated measures|Fixed effects of treatment group, treatment day, and study day by treatment interaction, with baseline measured at each study day as a covariate.||||104.91|47.76|<0.0001
72344447|NCT00422383|144211762|SUPERIORITY_OR_OTHER||Weighted Difference|-0.01||||0.8156|TWO_SIDED|95.0|-0.13|0.1|||Cochran-Mantel-Haenszel||Analysis stratified by region, prior biologic use, rheumatoid factor (RF) status, and treatment.|||0.10|-0.13|0.8156
72344448|NCT00422383|144211762|SUPERIORITY_OR_OTHER||Weighted Difference|0.07||||0.2419|TWO_SIDED|95.0|-0.05|0.19|||Cochran-Mantel-Haenszel||Analysis stratified by region, prior biologic use, RF status, and treatment.|||0.19|-0.05|0.2419
72344449|NCT00422383|144211765|SUPERIORITY_OR_OTHER|||||||0.7127|TWO_SIDED|||||Stratified by region, prior biologic use, RF status and treatment.|ANOVA|||||||0.7127
72344450|NCT00422383|144211765|SUPERIORITY_OR_OTHER|||||||0.1018|TWO_SIDED|||||Stratified by region, prior biologic use, RF status and treatment.|ANOVA|||||||0.1018
72344451|NCT00422383|144211766|SUPERIORITY_OR_OTHER|||||||0.5029|TWO_SIDED|||||Stratified by region, prior biologic use, RF status, and treatment.|Cochran-Mantel-Haenszel|||||||0.5029
72344452|NCT00422383|144211766|SUPERIORITY_OR_OTHER|||||||0.0495|TWO_SIDED|||||Stratified by region, prior biologic use, RF status, and treatment.|Cochran-Mantel-Haenszel|||||||0.0495
72344453|NCT03738618|144211810|OTHER||Treatment difference|43.3|||<|0.001|TWO_SIDED|95.0|36.5|47.6|||Fisher Exact||95% exact Agresti-Min confidence intervals.|||47.6|36.5|<0.001
72344454|NCT03738618|144211811|OTHER||Treatment difference|22.0|||<|0.001|TWO_SIDED|95.0|14.9|25.7|||Fisher Exact||95% exact Agresti-Min confidence intervals.|Ongoing Pregnancy Rate in the Fresh Cycle||25.7|14.9|<0.001
72344455|NCT03738618|144211815|OTHER||Treatment difference|26.8|||<|0.001|TWO_SIDED|95.0|19.8|30.8|||Fisher Exact||95% exact Agresti-Min confidence intervals.|Clinical pregnancy rate in the fresh cycle||30.8|19.8|<0.001
72344456|NCT03738618|144211815|OTHER||Treatment difference|52.0|||<|0.001|TWO_SIDED|95.0|44.9|56.3|||Fisher Exact||95% exact Agresti-Min confidence intervals.|Clinical pregnancy rate cumulatively||56.3|44.9|<0.001
72344457|NCT03738618|144211816|OTHER||Treatment difference|23.5|||<|0.001|TWO_SIDED|95.0|16.7|27.2|||Fisher Exact||95% exact Agresti-Min confidence intervals.|Vital pregnancy rate in the fresh cycle||27.2|16.7|<0.001
72344458|NCT03738618|144211816|OTHER||Treatment difference|45.6|||<|0.001|TWO_SIDED|95.0|38.5|49.9|||Fisher Exact||95% exact Agresti-Min confidence intervals.|Vital pregnancy rate cumulatively||49.9|38.5|<0.001
72344459|NCT03738618|144211818|OTHER||Treatment difference|32.1|||<|0.001|TWO_SIDED|95.0|24.9|36.2|||Fisher Exact||95% exact Agresti-Min confidence intervals.|Positive βhCG rate in the fresh cycle||36.2|24.9|<0.001
72344460|NCT03738618|144211818|OTHER||Treatment difference|58.9|||<|0.001|TWO_SIDED|95.0|51.9|63.0|||Fisher Exact||95% exact Agresti-Min confidence intervals.|Positive βhCG rate cumulatively||63.0|51.9|<0.001
72344461|NCT03738618|144211830|OTHER||||||<|0.001|||||||Wilcoxon rank sum test|||||||<0.001
72344462|NCT03738618|144211831|OTHER||||||<|0.001|||||||Wilcoxon rank sum test|||||||<0.001
72344463|NCT03738618|144211832|OTHER|||||||0.19|||||||Fisher Exact|||||||0.190
72344464|NCT03738618|144211833|OTHER|||||||0.396|||||||Fisher Exact|||||||0.396
72370152|NCT02028208|144250663|OTHER|Concordance between 0.40 mg/cm2 mercury and 1.0% ammoniated mercury in petrolatum|Kappa statistic|0.38|||||TWO_SIDED|95.0|0.08|0.67||||||Concordance between Investigational and Reference Allergen presented for allergen doses which met the minimum criteria of 70% with positive reactions.||0.67|0.08|
72370153|NCT02028208|144250663|OTHER|Concordance between 0.40 mercury and 0.5% elemental mercury in petrolatum|Kappa statistic|0.67|||||TWO_SIDED|95.0|0.35|0.99||||||Concordance between Investigational and Reference Allergen presented for allergen doses which met the minimum criteria of 70% with positive reactions.||0.99|0.35|
72344465|NCT00649428|144211879|SUPERIORITY_OR_OTHER|||||||1e-05|TWO_SIDED|95.0|||||Cochran-Mantel-Haenszel|Stratified by combined treatment site.||A 5% level of significance was used as the threshold for determination of statistical significance, and all tests were two-tailed. the effect size and associated 95% confidence interval (CI) are provided for all comparative efficacy outcomes. Primary analysis of the two co-primary efficacy endpoints and the secondary efficacy endpoints were performed on the ITT population.||||.00001
72344466|NCT00649428|144211882|SUPERIORITY_OR_OTHER||||||<|1e-05|TWO_SIDED|95.0|||||Cochran-Mantel-Haenszel|Stratified by combined treatment site.||A 5% level of significance was used as the threshold for determination of statistical significance, and all tests were two-tailed. the effect size and associated 95% confidence interval (CI) are provided for all comparative efficacy outcomes. Primary analysis of the two co-primary efficacy endpoints and the secondary efficacy endpoints were performed on the ITT population.||||<.00001
72344467|NCT04566601|144211890|OTHER|No formal hypotheses were tested.|Mean Difference (Net)|0.7||||0.4994|TWO_SIDED|95.0|-1.31|2.69||P-value is considered nominal.|Mixed effects model repeated measures||"Least Squares Mean of BI 1358894 5mg - Least Squares Mean of Placebo."|Least Squares (LS) mean difference and 95 % confidence interval were estimated by REML-based MMRM including the fixed categorical covariates of treatment, visit (baseline and Week 1, 2, 4, 6, 8, 10) and the baseline ZAN-BPD total score strata indicator (\<=18 vs. \>=19), the continuous fixed covariate of baseline ZAN-BPD total score, and treatment-by-visit interaction, as well as baseline-by-visit interaction. LS means differences (95 % confidence intervals) for Week 10 are reported.||2.69|-1.31|0.4994
72344468|NCT04566601|144211890|OTHER|No formal hypotheses were tested.|Mean Difference (Net)|-0.6||||0.6014|TWO_SIDED|95.0|-2.6|1.51||P-value is considered nominal.|Mixed effects model repeated measures||"Least Squares Mean of BI 1358894 25mg - Least Squares Mean of Placebo."|Least Squares (LS) mean difference and 95 % confidence interval were estimated by REML-based MMRM including the fixed categorical covariates of treatment, visit (baseline and Week 1, 2, 4, 6, 8, 10) and the baseline ZAN-BPD total score strata indicator (\<=18 vs. \>=19), the continuous fixed covariate of baseline ZAN-BPD total score, and treatment-by-visit interaction, as well as baseline-by-visit interaction. LS means differences (95 % confidence intervals) for Week 10 are reported.||1.51|-2.60|0.6014
72344469|NCT04566601|144211890|OTHER|No formal hypotheses were tested.|Mean Difference (Net)|-0.2||||0.8166|TWO_SIDED|95.0|-2.17|1.72||P-value is considered nominal.|Mixed effects model repeated measures||"Least Squares Mean of BI 1358894 75mg - Least Squares Mean of Placebo."|Least Squares (LS) mean difference and 95 % confidence interval were estimated by REML-based MMRM including the fixed categorical covariates of treatment, visit (baseline and Week 1, 2, 4, 6, 8, 10) and the baseline ZAN-BPD total score strata indicator (\<=18 vs. \>=19), the continuous fixed covariate of baseline ZAN-BPD total score, and treatment-by-visit interaction, as well as baseline-by-visit interaction. LS means differences (95 % confidence intervals) for Week 10 are reported.||1.72|-2.17|0.8166
72344470|NCT04566601|144211890|OTHER|No formal hypotheses were tested.|Mean Difference (Net)|-0.4||||0.6588|TWO_SIDED|95.0|-1.96|1.24||P-value is considered nominal.|Mixed effects model repeated measures||"Least Squares Mean of BI 1358894 125mg - Least Squares Mean of Placebo."|Least Squares (LS) mean difference and 95 % confidence interval were estimated by REML-based MMRM including the fixed categorical covariates of treatment, visit (baseline and Week 1, 2, 4, 6, 8, 10) and the baseline ZAN-BPD total score strata indicator (\<=18 vs. \>=19), the continuous fixed covariate of baseline ZAN-BPD total score, and treatment-by-visit interaction, as well as baseline-by-visit interaction. LS means differences (95 % confidence intervals) for Week 10 are reported.||1.24|-1.96|0.6588
72344471|NCT04566601|144211890|OTHER|MMRM estimates were used as input for the MCP-Mod. MMRM included the fixed categorical covariates of treatment, visit (baseline and Week 1, 2, 4, 6, 8, 10) and the baseline ZAN-BPD total score strata indicator (\<=18 vs. \>=19), the continuous fixed covariate of baseline ZAN-BPD total score, and treatment-by-visit interaction, as well as baseline-by-visit interaction.||||||0.3914|||||||MCP-Mod sigmoid Emax model fit|Model assumption: 50% of the maximum effect is achieved at 25 mg, and 90% of the maximum effect is achieved at 75 mg.||A flat vs. non-flat dose-response relationship across the 4 doses of BI 1358894 and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, exponential, Emax 1, Emax 2 and Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.100).||||0.3914
72344472|NCT04566601|144211890|OTHER|MMRM estimates were used as input for the MCP-Mod. MMRM included the fixed categorical covariates of treatment, visit (baseline and Week 1, 2, 4, 6, 8, 10 and 12) and the baseline ZAN-BPD total score strata indicator (\<=18 vs. \>=19), the continuous fixed covariate of baseline ZAN-BPD total score, and treatment-by-visit interaction, as well as baseline-by-visit interaction.||||||0.4104|||||||MCP-Mod Emax1 model fit|Model assumption: 50% of the maximum effect is achieved at 25 mg.||A flat vs. non-flat dose-response relationship across the 4 doses of BI 1358894 and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, exponential, Emax 1, Emax 2 and Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.100).||||0.4104
72344473|NCT04566601|144211890|OTHER|MMRM estimates were used as input for the MCP-Mod. MMRM included the fixed categorical covariates of treatment, visit (baseline and Week 1, 2, 4, 6, 8, 10) and the baseline ZAN-BPD total score strata indicator (\<=18 vs. \>=19), the continuous fixed covariate of baseline ZAN-BPD total score, and treatment-by-visit interaction, as well as baseline-by-visit interaction.||||||0.456|||||||MCP-Mod linear model fit|Model assumption: No parameter assumptions required.||A flat vs. non-flat dose-response relationship across the 4 doses of BI 1358894 and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, exponential, Emax 1, Emax 2 and Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.100).||||0.4560
72370154|NCT02028208|144250663|OTHER|Concordance between 0.36 mg/cm2 mercury and 1.0% ammoniated mercury in petrolatum|Kappa statistic|0.46|||||TWO_SIDED|95.0|0.15|0.76||||||Concordance between Investigational and Reference Allergen presented for allergen doses which met the minimum criteria of 70% with positive reactions.||0.76|0.15|
72370155|NCT02028208|144250663|OTHER|Concordance between 0.36 mg/cm2 mercury and 0.5% elemental mercury in petrolatum|Kappa statistic|0.57|||||TWO_SIDED|95.0|0.21|0.93||||||Concordance between Investigational and Reference Allergen presented for allergen doses which met the minimum criteria of 70% with positive reactions.||0.93|0.21|
72344474|NCT04566601|144211890|OTHER|MMRM estimates were used as input for the MCP-Mod. MMRM included the fixed categorical covariates of treatment, visit (baseline and Week 1, 2, 4, 6, 8, 10) and the baseline ZAN-BPD total score strata indicator (\<=18 vs. \>=19), the continuous fixed covariate of baseline ZAN-BPD total score, and treatment-by-visit interaction, as well as baseline-by-visit interaction.||||||0.4908|||||||MCP-Mod exponential model fit|Model assumption: 5% of the maximum effect is achieved at 25 mg.||A flat vs. non-flat dose-response relationship across the 4 doses of BI 1358894 and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, exponential, Emax 1, Emax 2 and Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.100).||||0.4908
72344475|NCT04566601|144211890|OTHER|MMRM estimates were used as input for the MCP-Mod. MMRM included the fixed categorical covariates of treatment, visit (baseline and Week 1, 2, 4, 6, 8, 10) and the baseline ZAN-BPD total score strata indicator (\<=18 vs. \>=19), the continuous fixed covariate of baseline ZAN-BPD total score, and treatment-by-visit interaction, as well as baseline-by-visit interaction.||||||0.4974|||||||MCP-Mod Emax2 model fit|Model assumption: 70% of the maximum effect is achieved at 5 mg.||A flat vs. non-flat dose-response relationship across the 4 doses of BI 1358894 and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, exponential, Emax 1, Emax 2 and Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.100).||||0.4974
72344476|NCT04566601|144211891|OTHER||Odds Ratio (OR)|0.486|||||TWO_SIDED|95.0|0.207|1.14|||||Odds Ratio of BI 1358894 5mg vs. Placebo.|The odds ratio (OR) and associated confidence intervals between the active treatment arm versus placebo were calculated through a logistic regression model that was adjusted for fixed factors of treatment, baseline ZAN-BPD strata indicator (≤18 vs. ≥19), and the continuous covariate of baseline ZAN-BPD total score.||1.140|0.207|
72344477|NCT04566601|144211891|OTHER||Odds Ratio (OR)|2.294|||||TWO_SIDED|95.0|0.829|7.48|||||Odds Ratio of BI 1358894 25mg vs. Placebo.|The odds ratio (OR) and associated confidence intervals between the active treatment arm versus placebo were calculated through a logistic regression model that was adjusted for fixed factors of treatment, baseline ZAN-BPD strata indicator (≤18 vs. ≥19), and the continuous covariate of baseline ZAN-BPD total score.||7.480|0.829|
72344478|NCT04566601|144211891|OTHER||Odds Ratio (OR)|1.753|||||TWO_SIDED|95.0|0.698|4.861|||||Odds Ratio of BI 1358894 75mg vs. Placebo.|The odds ratio (OR) and associated confidence intervals between the active treatment arm versus placebo were calculated through a logistic regression model that was adjusted for fixed factors of treatment, baseline ZAN-BPD strata indicator (≤18 vs. ≥19), and the continuous covariate of baseline ZAN-BPD total score.||4.861|0.698|
72344479|NCT04566601|144211891|OTHER||Odds Ratio (OR)|1.352|||||TWO_SIDED|95.0|0.642|2.913|||||Odds Ratio of BI 1358894 125mg vs. Placebo.|The odds ratio (OR) and associated confidence intervals between the active treatment arm versus placebo were calculated through a logistic regression model that was adjusted for fixed factors of treatment, baseline ZAN-BPD strata indicator (≤18 vs. ≥19), and the continuous covariate of baseline ZAN-BPD total score.||2.913|0.642|
72344480|NCT04566601|144211892|OTHER|No formal hypotheses were tested.|Mean Difference (Net)|-0.1||||0.9675|TWO_SIDED|95.0|-5.11|4.9||P-value is considered nominal.|Mixed effects model repeated measures||"Least Squares Mean of BI 1358894 5mg - Least Squares Mean of Placebo."|Least Squares (LS) mean difference and 95% confidence interval were estimated by REML-based MMRM including the fixed categorical covariates of treatment, visit (baseline and Week 1, 2, 4, 6, 8, 10) and the continuous fixed covariate of baseline DERS-16 total score, and treatment-by-visit interaction, as well as baseline-by-visit interaction. Patient was considered as random. Unstructured covariance matrix was used.||4.90|-5.11|0.9675
72344481|NCT04566601|144211892|OTHER|No formal hypotheses were tested.|Mean Difference (Net)|0.01||||0.9969|TWO_SIDED|95.0|-5.08|5.1||P-value is considered nominal.|Mixed effects model repeated measures||"Least Squares Mean of BI 1358894 25mg - Least Squares Mean of Placebo."|Least Squares (LS) mean difference and 95% confidence interval were estimated by REML-based MMRM including the fixed categorical covariates of treatment, visit (baseline and Week 1, 2, 4, 6, 8, 10) and the continuous fixed covariate of baseline DERS-16 total score, and treatment-by-visit interaction, as well as baseline-by-visit interaction. Patient was considered as random. Unstructured covariance matrix was used.||5.10|-5.08|0.9969
72344482|NCT04566601|144211892|OTHER|No formal hypotheses were tested.|Mean Difference (Net)|-0.79||||0.7542|TWO_SIDED|95.0|-5.73|4.15||P-value is considered nominal.|Mixed effects model repeated measures||"Least Squares Mean of BI 1358894 75mg - Least Squares Mean of Placebo."|Least Squares (LS) mean difference and 95% confidence interval were estimated by REML-based MMRM including the fixed categorical covariates of treatment, visit (baseline and Week 1, 2, 4, 6, 8, 10) and the continuous fixed covariate of baseline DERS-16 total score, and treatment-by-visit interaction, as well as baseline-by-visit interaction. Patient was considered as random. Unstructured covariance matrix was used.||4.15|-5.73|0.7542
72344483|NCT04566601|144211892|OTHER|No formal hypotheses were tested.|Mean Difference (Net)|1.17||||0.5683|TWO_SIDED|95.0|-2.86|5.19||P-value is considered nominal.|Mixed effects model repeated measures||"Least Squares Mean of BI 1358894 125mg - Least Squares Mean of Placebo."|Least Squares (LS) mean difference and 95% confidence interval were estimated by REML-based MMRM including the fixed categorical covariates of treatment, visit (baseline and Week 1, 2, 4, 6, 8, 10) and the continuous fixed covariate of baseline DERS-16 total score, and treatment-by-visit interaction, as well as baseline-by-visit interaction. Patient was considered as random. Unstructured covariance matrix was used.||5.19|-2.86|0.5683
72344484|NCT04566601|144211893|OTHER|No formal hypotheses were tested.|Mean Difference (Net)|-2.07||||0.3568|TWO_SIDED|95.0|-6.49|2.35||P-value is considered nominal.|Mixed effects model repeated measures||"Least Squares Mean of BI 1358894 5mg - Least Squares Mean of Placebo."|Least Squares (LS) mean difference and 95% confidence interval were estimated by restricted maximum likelihood-based mixed effects model repeated measures (REML-based MMRM) including the fixed categorical covariates of treatment, visit (baseline and Week 1, 2, 4, 6, 8, 10) and the continuous fixed covariate of baseline STAI-S total score, and treatment-by-visit interaction, as well as baseline-by-visit interaction. Patient was considered as random. Unstructured covariance matrix was used.||2.35|-6.49|0.3568
72344485|NCT04566601|144211893|OTHER|No formal hypotheses were tested.|Mean Difference (Net)|1.21||||0.6009|TWO_SIDED|95.0|-3.33|5.75||P-value is considered nominal.|Mixed effects model repeated measures||"Least Squares Mean of BI 1358894 25mg - Least Squares Mean of Placebo."|Least Squares (LS) mean difference and 95% confidence interval were estimated by restricted maximum likelihood-based mixed effects model repeated measures (REML-based MMRM) including the fixed categorical covariates of treatment, visit (baseline and Week 1, 2, 4, 6, 8, 10) and the continuous fixed covariate of baseline STAI-S total score, and treatment-by-visit interaction, as well as baseline-by-visit interaction. Patient was considered as random. Unstructured covariance matrix was used.||5.75|-3.33|0.6009
72344486|NCT04566601|144211893|OTHER|No formal hypotheses were tested.|Mean Difference (Net)|-0.36||||0.8705|TWO_SIDED|95.0|-4.7|3.98||P-value is considered nominal.|Mixed effects model repeated measures||"Least Squares Mean of BI 1358894 75mg - Least Squares Mean of Placebo."|Least Squares (LS) mean difference and 95% confidence interval were estimated by restricted maximum likelihood-based mixed effects model repeated measures (REML-based MMRM) including the fixed categorical covariates of treatment, visit (baseline and Week 1, 2, 4, 6, 8, 10) and the continuous fixed covariate of baseline STAI-S total score, and treatment-by-visit interaction, as well as baseline-by-visit interaction. Patient was considered as random. Unstructured covariance matrix was used.||3.98|-4.70|0.8705
72344487|NCT04566601|144211893|OTHER|No formal hypotheses were tested.|Mean Difference (Net)|1.15||||0.5262|TWO_SIDED|95.0|-2.41|4.71||P-value is considered nominal.|Mixed effects model repeated measures||"Least Squares Mean of BI 1358894 125mg - Least Squares Mean of Placebo."|Least Squares (LS) mean difference and 95% confidence interval were estimated by restricted maximum likelihood-based mixed effects model repeated measures (REML-based MMRM) including the fixed categorical covariates of treatment, visit (baseline and Week 1, 2, 4, 6, 8, 10) and the continuous fixed covariate of baseline STAI-S total score, and treatment-by-visit interaction, as well as baseline-by-visit interaction. Patient was considered as random. Unstructured covariance matrix was used.||4.71|-2.41|0.5262
72344488|NCT04566601|144211894|OTHER|No formal hypotheses were tested.|Mean Difference (Net)|-1.83||||0.0782|TWO_SIDED|95.0|-3.87|0.21||P-value is considered nominal.|Mixed effects model repeated measures||"Least Squares Mean of BI 1358894 5mg - Least Squares Mean of Placebo."|Least Squares (LS) mean difference and 95% confidence interval were estimated by restricted maximum likelihood-based mixed effects model repeated measures (REML-based MMRM) including the fixed categorical covariates of treatment, visit (baseline and Week 1, 2, 4, 6, 8, 10) and the continuous fixed covariate of baseline PHQ-9 total score, and treatment-by-visit interaction, as well as baseline-by-visit interaction. Patient was considered as random. Unstructured covariance matrix was used.||0.21|-3.87|0.0782
72344489|NCT04566601|144211894|OTHER|No formal hypotheses were tested.|Mean Difference (Net)|0.23||||0.8266|TWO_SIDED|95.0|-1.86|2.32||P-value is considered nominal.|Mixed effects model repeated measures||"Least Squares Mean of BI 1358894 25mg - Least Squares Mean of Placebo."|Least Squares (LS) mean difference and 95% confidence interval were estimated by restricted maximum likelihood-based mixed effects model repeated measures (REML-based MMRM) including the fixed categorical covariates of treatment, visit (baseline and Week 1, 2, 4, 6, 8, 10) and the continuous fixed covariate of baseline PHQ-9 total score, and treatment-by-visit interaction, as well as baseline-by-visit interaction. Patient was considered as random. Unstructured covariance matrix was used.||2.32|-1.86|0.8266
72344490|NCT04566601|144211894|OTHER|No formal hypotheses were tested.|Mean Difference (Net)|-0.27||||0.791|TWO_SIDED|95.0|-2.28|1.74||P-value is considered nominal.|Mixed effects model repeated measures||"Least Squares Mean of BI 1358894 75mg - Least Squares Mean of Placebo."|Least Squares (LS) mean difference and 95% confidence interval were estimated by restricted maximum likelihood-based mixed effects model repeated measures (REML-based MMRM) including the fixed categorical covariates of treatment, visit (baseline and Week 1, 2, 4, 6, 8, 10) and the continuous fixed covariate of baseline PHQ-9 total score, and treatment-by-visit interaction, as well as baseline-by-visit interaction. Patient was considered as random. Unstructured covariance matrix was used.||1.74|-2.28|0.7910
72344491|NCT04566601|144211894|OTHER|No formal hypotheses were tested.|Mean Difference (Net)|-0.13||||0.8743|TWO_SIDED|95.0|-1.77|1.51||P-value is considered nominal.|Mixed effects model repeated measures||"Least Squares Mean of BI 1358894 125mg - Least Squares Mean of Placebo."|Least Squares (LS) mean difference and 95% confidence interval were estimated by restricted maximum likelihood-based mixed effects model repeated measures (REML-based MMRM) including the fixed categorical covariates of treatment, visit (baseline and Week 1, 2, 4, 6, 8, 10) and the continuous fixed covariate of baseline PHQ-9 total score, and treatment-by-visit interaction, as well as baseline-by-visit interaction. Patient was considered as random. Unstructured covariance matrix was used.||1.51|-1.77|0.8743
72428759|NCT04147260|144368589|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|2.19|STANDARD_ERROR_OF_MEAN|11.544||0.851|TWO_SIDED|90.0|-21.12|25.5||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||25.50|-21.12|0.851
72344492|NCT04566601|144211895|OTHER|No formal hypotheses were tested.|Mean Difference (Net)|-0.05||||0.8016|TWO_SIDED|95.0|-0.47|0.37||P-value is considered nominal.|Mixed effects model repeated measures||"Least Squares Mean of BI 1358894 5mg - Least Squares Mean of Placebo."|Least Squares (LS) mean difference and 95% confidence interval were estimated by restricted maximum likelihood-based mixed effects model repeated measures (REML-based MMRM) including the fixed categorical covariates of treatment, visit (baseline and Week 1, 2, 4, 6, 8, 10) and the continuous fixed covariate of baseline CGI-S total score, and treatment-by-visit interaction, as well as baseline-by-visit interaction. Patient was considered as random. Unstructured covariance matrix was used.||0.37|-0.47|0.8016
72344493|NCT04566601|144211895|OTHER|No formal hypotheses were tested.|Mean Difference (Net)|-0.23||||0.2929|TWO_SIDED|95.0|-0.67|0.2||P-value is considered nominal.|Mixed effects model repeated measures||"Least Squares Mean of BI 1358894 25mg - Least Squares Mean of Placebo."|Least Squares (LS) mean difference and 95% confidence interval were estimated by restricted maximum likelihood-based mixed effects model repeated measures (REML-based MMRM) including the fixed categorical covariates of treatment, visit (baseline and Week 1, 2, 4, 6, 8, 10) and the continuous fixed covariate of baseline CGI-S total score, and treatment-by-visit interaction, as well as baseline-by-visit interaction. Patient was considered as random. Unstructured covariance matrix was used.||0.20|-0.67|0.2929
72344494|NCT04566601|144211895|OTHER|No formal hypotheses were tested.|Mean Difference (Net)|-0.01||||0.9666|TWO_SIDED|95.0|-0.42|0.4||P-value is considered nominal.|Mixed effects model repeated measures||"Least Squares Mean of BI 1358894 75mg - Least Squares Mean of Placebo."|Least Squares (LS) mean difference and 95% confidence interval were estimated by restricted maximum likelihood-based mixed effects model repeated measures (REML-based MMRM) including the fixed categorical covariates of treatment, visit (baseline and Week 1, 2, 4, 6, 8, 10) and the continuous fixed covariate of baseline CGI-S total score, and treatment-by-visit interaction, as well as baseline-by-visit interaction. Patient was considered as random. Unstructured covariance matrix was used.||0.40|-0.42|0.9666
72344495|NCT04566601|144211895|OTHER|No formal hypotheses were tested.|Mean Difference (Net)|-0.18||||0.2833|TWO_SIDED|95.0|-0.52|0.15||P-value is considered nominal.|Mixed effects model repeated measures||"Least Squares Mean of BI 1358894 125mg - Least Squares Mean of Placebo."|Least Squares (LS) mean difference and 95% confidence interval were estimated by restricted maximum likelihood-based mixed effects model repeated measures (REML-based MMRM) including the fixed categorical covariates of treatment, visit (baseline and Week 1, 2, 4, 6, 8, 10) and the continuous fixed covariate of baseline CGI-S total score, and treatment-by-visit interaction, as well as baseline-by-visit interaction. Patient was considered as random. Unstructured covariance matrix was used.||0.15|-0.52|0.2833
72344496|NCT04566601|144211896|OTHER|No formal hypotheses were tested.|Mean Difference (Net)|-0.13||||0.4552|TWO_SIDED|95.0|-0.45|0.2||P-value is considered nominal.|Mixed effects model repeated measures||"Least Squares Mean of BI 1358894 5mg - Least Squares Mean of Placebo."|Least Squares (LS) mean difference and 95% confidence interval were estimated by restricted maximum likelihood-based mixed effects model repeated measures (REML-based MMRM) including the fixed categorical covariates of treatment, visit (baseline and Week 1, 2, 4, 6, 8, 10) and the continuous fixed covariate of baseline PGI-S total score, and treatment-by-visit interaction, as well as baseline-by-visit interaction. Patient was considered as random. Unstructured covariance matrix was used.||0.20|-0.45|0.4552
72344497|NCT04566601|144211896|OTHER|No formal hypotheses were tested.|Mean Difference (Net)|-0.13||||0.4734|TWO_SIDED|95.0|-0.47|0.22||P-value is considered nominal.|Mixed effects model repeated measures||"Least Squares Mean of BI 1358894 25mg - Least Squares Mean of Placebo."|Least Squares (LS) mean difference and 95% confidence interval were estimated by restricted maximum likelihood-based mixed effects model repeated measures (REML-based MMRM) including the fixed categorical covariates of treatment, visit (baseline and Week 1, 2, 4, 6, 8, 10) and the continuous fixed covariate of baseline PGI-S total score, and treatment-by-visit interaction, as well as baseline-by-visit interaction. Patient was considered as random. Unstructured covariance matrix was used.||0.22|-0.47|0.4734
72344498|NCT04566601|144211896|OTHER|No formal hypotheses were tested.|Mean Difference (Net)|-0.03||||0.8388|TWO_SIDED|95.0|-0.36|0.29||P-value is considered nominal.|Mixed effects model repeated measures||"Least Squares Mean of BI 1358894 75mg - Least Squares Mean of Placebo."|Least Squares (LS) mean difference and 95% confidence interval were estimated by restricted maximum likelihood-based mixed effects model repeated measures (REML-based MMRM) including the fixed categorical covariates of treatment, visit (baseline and Week 1, 2, 4, 6, 8, 10) and the continuous fixed covariate of baseline PGI-S total score, and treatment-by-visit interaction, as well as baseline-by-visit interaction. Patient was considered as random. Unstructured covariance matrix was used.||0.29|-0.36|0.8388
72344499|NCT04566601|144211896|OTHER|No formal hypotheses were tested.|Mean Difference (Net)|-0.08||||0.554|TWO_SIDED|95.0|-0.35|0.19||P-value is considered nominal.|Mixed effects model repeated measures||"Least Squares Mean of BI 1358894 125mg - Least Squares Mean of Placebo."|Least Squares (LS) mean difference and 95% confidence interval were estimated by restricted maximum likelihood-based mixed effects model repeated measures (REML-based MMRM) including the fixed categorical covariates of treatment, visit (baseline and Week 1, 2, 4, 6, 8, 10) and the continuous fixed covariate of baseline PGI-S total score, and treatment-by-visit interaction, as well as baseline-by-visit interaction. Patient was considered as random. Unstructured covariance matrix was used.||0.19|-0.35|0.5540
72344500|NCT01272635|144211900|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.64||||0.04|TWO_SIDED|95.0|0.41|0.98|||Discrete time survival analysis||Hazard ratio: Numerator is Azithromycin and Denominator is Placebo|||0.98|0.41|0.04
72428760|NCT04147260|144368589|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|-26.64|STANDARD_ERROR_OF_MEAN|9.405||0.007|TWO_SIDED|90.0|-45.59|-7.69||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||-7.69|-45.59|0.007
72344501|NCT00183625|144211929|SUPERIORITY_OR_OTHER|||||||0.66|TWO_SIDED|95.0|||||Regression, Linear|||||||0.66
72344502|NCT00183625|144211930|SUPERIORITY_OR_OTHER|||||||0.0176||95.0||||The p-value listed is for the medication by time interaction.|Mixed Models Analysis|||Mixed effects regression of body mass index on medication group (risp or olanz), time (in days over first 18 months of study) and a group by time interaction with site and baseline timepoint indicators as covariates. The model included a random slope and intercept for time.||||.0176
72344503|NCT04856904|144211993|SUPERIORITY||Bilateral difference|-3.2|STANDARD_ERROR_OF_MEAN|0.6|<|0.0001|TWO_SIDED|95.0|-4.4|-2.0|||Student's t-test for paired samples|||||-2|-4.4|< 0.0001
72344504|NCT04856904|144211994|SUPERIORITY||Bilateral difference|0.0|STANDARD_ERROR_OF_MEAN|0.14|=|0.9476|TWO_SIDED|95.0|-0.3|0.3|||Student's t-test for paired samples|||Week 1: Trifarotene 50 mcg/g, vehicle cream||0.3|-0.3|= 0.9476
72344505|NCT04856904|144211994|SUPERIORITY||Bilateral difference|-0.6|STANDARD_ERROR_OF_MEAN|0.25|=|0.0248|TWO_SIDED|95.0|-1.1|-0.1|||Student's t-test for paired samples|||Week 2: Trifarotene 50 mcg/g, vehicle cream||-0.1|-1.1|= 0.0248
72344506|NCT04856904|144211994|SUPERIORITY||Bilateral difference|-0.8|STANDARD_ERROR_OF_MEAN|0.29|=|0.0072|TWO_SIDED|95.0|-1.4|-0.2|||Student's t-test for paired samples|||Week 4: Trifarotene 50 mcg/g, vehicle cream||-0.2|-1.4|= 0.0072
72344507|NCT04856904|144211994|SUPERIORITY||Bilateral difference|-1.4|STANDARD_ERROR_OF_MEAN|0.35|<|0.0001|TWO_SIDED|95.0|-2.1|-0.7|||Student's t-test for paired samples|||Week 8: Trifarotene 50 mcg/g, vehicle cream||-0.7|-2.1|< 0.0001
72344508|NCT04856904|144211994|SUPERIORITY||Bilateral difference|-2.1|STANDARD_ERROR_OF_MEAN|0.41|<|0.0001|TWO_SIDED|95.0|-2.9|-1.3|||Student's t-test for paired samples|||Week 12: Trifarotene 50 mcg/g, vehicle cream||-1.3|-2.9|< 0.0001
72344509|NCT04856904|144211994|SUPERIORITY||Bilateral difference|-2.7|STANDARD_ERROR_OF_MEAN|0.56|<|0.0001|TWO_SIDED|95.0|-3.8|-1.6|||Student's t-test for paired samples|||Week 16: Trifarotene 50 mcg/g, vehicle cream||-1.6|-3.8|< 0.0001
72344510|NCT04856904|144211994|SUPERIORITY||Bilateral difference|-2.5|STANDARD_ERROR_OF_MEAN|0.53|<|0.0001|TWO_SIDED|95.0|-3.5|-1.5|||Student's t-test for paired samples|||Week 20: Trifarotene 50 mcg/g, vehicle cream||-1.5|-3.5|< 0.0001
72344511|NCT00454181|144212038|SUPERIORITY_OR_OTHER|||||||0.3||95.0|||||Chi-squared|||Chi-square analysis of the proportion of subjects in each group meeting the definition of positive response.||||0.30
72344512|NCT00454181|144212039|SUPERIORITY_OR_OTHER|||||||0.26||95.0|||||Chi-squared|||Chi-square analysis of the proportion of subjects in each group meeting the definition of positive response||||0.26
72344513|NCT00454181|144212040|SUPERIORITY_OR_OTHER|||||||0.5||95.0|||||Chi-squared|||"Chi-square analysis of the proportion of subjects in each group reporting change in oral warts from baseline to week 24 as better."||||0.50
72344514|NCT00454181|144212041|SUPERIORITY_OR_OTHER|||||||0.29||95.0|||||Chi-squared|||"Chi-square analysis of the proportion of subjects in each group reporting change in global oral health from baseline to week 24 as better."||||0.29
72344515|NCT00454181|144212042|SUPERIORITY_OR_OTHER|||||||0.74||95.0|||||Chi-squared|||"Chi-square analysis of the proportion of subjects rated as improved with respect to changes in oral warts from baseline to week 24 by the attending investigator."||||0.74
72344516|NCT00454181|144212043|SUPERIORITY_OR_OTHER|||||||0.71||95.0|||||Chi-squared|||"Chi-square analysis of the proportion of subjects rated as improved with resepect to changes from baseline to week 24 in global oral health by the attending investigator."||||.71
72344517|NCT03045341|144212044|SUPERIORITY|Analyses used all available data.||||||0.0001|||||||Mixed Models Analysis|Analyses to compare treatments were all intent-to-treat. Analyses were performed for all randomized patients who attended the first treatment session.||BWL versus no BWL||||0.0001
72344518|NCT03045341|144212044|SUPERIORITY|Analyses used all available data.||||||0.58|||||||Mixed Models Analysis|Analyses to compare treatments were all intent-to-treat. Analyses were performed for all randomized patients who attended the first treatment session.||NB versus placebo||||0.58
72344519|NCT03045341|144212045|SUPERIORITY|Analyses used all available data.||||||0.0001|||||||Mixed Models Analysis|Analyses to compare treatments were all intent-to-treat. Analyses were performed for all randomized patients who attended the first treatment session.||BWL versus no BWL||||0.0001
72344520|NCT03045341|144212045|SUPERIORITY|Analyses used all available data.||||||0.63|||||||Mixed Models Analysis|Analyses to compare treatments were all intent-to-treat. Analyses were performed for all randomized patients who attended the first treatment session.||NB versus placebo||||0.63
72344521|NCT03045341|144212046|SUPERIORITY|||||||0.004|||||||Chi-squared|||Analyses used all available data.||||.004
72344522|NCT02772978|144212064|SUPERIORITY|||||||0.04||||||The threshold for statistical significance was set to p \< 0.05.|Fisher transformation|||The comparison group represents the difference in ICR and the baseline impulsiveness scale, non-planning subscale.||||0.04
72344523|NCT02772978|144212065|SUPERIORITY||||||<|0.05||||||The threshold is set to p \< 0.05, corrected for multiple comparisons.|Fisher transformation|||||||< 0.05
72344524|NCT02540993|144212106|SUPERIORITY||Hazard Ratio (HR)|0.825|||=|0.0014|TWO_SIDED|95.0|0.732|0.928||P-value from stratified log-rank test. Significance was considered to be achieved if p-value ≤ 0.03282695.|Log Rank|Stratified log rank test|A stratified Cox proportional hazards regression model was used to provide a point estimate of the hazard ratio and a corresponding two-sided 95% confidence interval.|||0.928|0.732|= 0.0014
72344525|NCT02540993|144212107|SUPERIORITY||Hazard Ratio (HR)|0.86|||=|0.0339|TWO_SIDED|95.0|0.747|0.989||P-value from stratified log-rank test. Significance was considered to be achieved if p-value ≤ 0.04967388.|Log Rank|Stratified log rank test|A stratified Cox proportional hazards regression model was used to provide a point estimate of the hazard ratio and a corresponding two-sided 95% confidence interval.|||0.989|0.747|= 0.0339
72344526|NCT02540993|144212108|SUPERIORITY|If treatment effect on both primary and key secondary endpoint is significant, other secondary efficacy endpoints (i.e. all-cause mortality, all-cause hospitalization, change in UACR from baseline to Month 4, and secondary renal composite endpoint) will be tested hierarchically, starting with all-cause mortality. If treatment effect on all-cause mortality was not significant, all other endpoints would be tested in an exploratory manner.|Hazard Ratio (HR)|0.895|||=|0.2348|TWO_SIDED|95.0|0.746|1.075||P-value from stratified log-rank test. Significance was considered to be achieved if p-value ≤ 0.04967388.|Log Rank|Stratified log rank test|A stratified Cox proportional hazards regression model was used to provide a point estimate of the hazard ratio and a corresponding two-sided 95% confidence interval.|||1.075|0.746|= 0.2348
72344527|NCT02540993|144212109|SUPERIORITY|If treatment effect on both primary and key secondary endpoint is significant, other secondary efficacy endpoints (i.e. all-cause mortality, all-cause hospitalization, change in UACR from baseline to Month 4, and secondary renal composite endpoint) will be tested hierarchically, starting with all-cause mortality. If treatment effect on all-cause mortality was not significant, all other endpoints would be tested in an exploratory manner.|Hazard Ratio (HR)|0.946|||=|0.1623|TWO_SIDED|95.0|0.876|1.022||P-value from stratified log-rank test.|Log Rank|Stratified log rank test|A stratified Cox proportional hazards regression model was used to provide a point estimate of the hazard ratio and a corresponding two-sided 95% confidence interval.|||1.022|0.876|= 0.1623
72344528|NCT02540993|144212110|SUPERIORITY|If treatment effect on both primary and key secondary endpoint is significant, other secondary efficacy endpoints (i.e. all-cause mortality, all-cause hospitalization, change in UACR from baseline to Month 4, and secondary renal composite endpoint) will be tested hierarchically, starting with all-cause mortality. If treatment effect on all-cause mortality was not significant, all other endpoints would be tested in an exploratory manner.|Ratio of least squares means|0.688|||<|0.0001|TWO_SIDED|95.0|0.662|0.715||P-value from F-test of equal means between the treatment groups.|ANCOVA|||||0.715|0.662|< 0.0001
72370156|NCT02028208|144250663|OTHER|Concordance between 0.10 mg/cm2 palladium and 3.0% sodium tetrachloropalladate in petrolatum|Kappa statistic|0.48|||||TWO_SIDED|95.0|0.05|0.9||||||Concordance between Investigational and Reference Allergen presented for allergen doses which met the minimum criteria of 70% with positive reactions.||0.90|0.05|
72370157|NCT02028208|144250663|OTHER|Concordance between 0.10 mg/cm2 palladium and 1.0% palladium chloride in petrolatum|Kappa statistic|0.39|||||TWO_SIDED|95.0|0.1|0.68||||||Concordance between Investigational and Reference Allergen presented for allergen doses which met the minimum criteria of 70% with positive reactions.||0.68|0.10|
72370158|NCT02028208|144250663|OTHER||Kappa statistic|0.83|||||TWO_SIDED|95.0|0.5|1.0||||||Concordance between 0.30 mg/cm2 palladium and 3.0% sodium tetrachloropalladate in petrolatum||1.00|0.50|
72344529|NCT02540993|144212111|SUPERIORITY|If treatment effect on both primary and key secondary endpoint is significant, other secondary efficacy endpoints (i.e. all-cause mortality, all-cause hospitalization, change in UACR from baseline to Month 4, and secondary renal composite endpoint) will be tested hierarchically, starting with all-cause mortality. If treatment effect on all-cause mortality was not significant, all other endpoints would be tested in an exploratory manner.|Hazard Ratio (HR)|0.763|||=|0.0012|TWO_SIDED|95.0|0.648|0.9||P-value from stratified log-rank test.|Log Rank|Stratified log rank test|A stratified Cox proportional hazards regression model was used to provide a point estimate of the hazard ratio and a corresponding two-sided 95% confidence interval.|||0.900|0.648|= 0.0012
72344530|NCT01009086|144212127|SUPERIORITY_OR_OTHER||||||<|0.001|||||||re-randomization test|||||||<0.001
72344531|NCT01009086|144212127|SUPERIORITY_OR_OTHER||||||<|0.001|||||||re-randomization test|||||||<0.001
72344532|NCT01009086|144212127|SUPERIORITY_OR_OTHER||||||<|0.001|||||||re-randomization test|||||||<0.001
72344533|NCT01009086|144212128|SUPERIORITY_OR_OTHER||||||<|0.001|||||||re-randomization test|||||||<0.001
72344534|NCT01009086|144212128|SUPERIORITY_OR_OTHER||||||<|0.001|||||||re-randomization test|||||||<0.001
72344535|NCT01009086|144212128|SUPERIORITY_OR_OTHER||||||<|0.001|||||||re-randomization test|||||||<0.001
72344536|NCT01009086|144212129|SUPERIORITY_OR_OTHER||||||<|0.001|||||||re-randomization test|||||||<0.001
72344537|NCT01009086|144212129|SUPERIORITY_OR_OTHER||||||<|0.001|||||||re-randomization test|||||||<0.001
72344538|NCT01009086|144212129|SUPERIORITY_OR_OTHER||||||<|0.001|||||||re-randomization test|||||||<0.001
72344539|NCT01009086|144212130|SUPERIORITY_OR_OTHER||||||<|0.001|||||||re-randomization test|||||||<0.001
72344540|NCT01009086|144212130|SUPERIORITY_OR_OTHER||||||<|0.001|||||||re-randomization test|||||||<0.001
72344541|NCT01009086|144212130|SUPERIORITY_OR_OTHER||||||<|0.001|||||||re-randomization test|||||||<0.001
72344542|NCT01009086|144212131|SUPERIORITY_OR_OTHER||||||<|0.001|||||||re-randomization test|||||||<0.001
72344543|NCT01009086|144212131|SUPERIORITY_OR_OTHER||||||<|0.001|||||||re-randomization test|||||||<0.001
72344544|NCT01009086|144212131|SUPERIORITY_OR_OTHER||||||<|0.001|||||||re-randomization test|||||||<0.001
72344545|NCT01009086|144212132|SUPERIORITY_OR_OTHER|||||||0.017|||||||re-randomization test|||||||0.017
72344546|NCT01009086|144212132|SUPERIORITY_OR_OTHER||||||<|0.001|||||||re-randomization test|||||||<0.001
72344547|NCT01009086|144212132|SUPERIORITY_OR_OTHER||||||<|0.001|||||||re-randomization test|||||||<0.001
72344548|NCT01192828|144212138|OTHER|Descriptive analysis||||||0.235|||||||t-test, 2 sided|paired||Null hypothesis applied.||||0.235
72344549|NCT01192828|144212139|OTHER|Descriptive analysis.||||||0.701|||||||t-test, 2 sided|paired||Null hypothesis assumed.||||0.701
72344550|NCT01192828|144212140|OTHER|Descriptive analysis.||||||0.19|||||||t-test, 2 sided|paired t-test||Null hypothesis applied.||||0.190
72344551|NCT01192828|144212141|OTHER|Descriptive analysis.||||||0.052|||||||t-test, 2 sided|paired t-test||Null hypothesis applied.||||0.052
72344552|NCT01192828|144212142|OTHER|Descriptive analysis.||||||0.014|||||||t-test, 2 sided|paired t-test||Null hypothesis assumed.||||0.014
72344553|NCT01192828|144212144|OTHER|Descriptive analysis||||||0.541|||||||Spearman's rank correlation|||Null hypothesis assumed|Spearman's rank correlation rho is 0.179, with p value 0.541, N is 14|||.541
72344554|NCT01192828|144212146|OTHER|Descriptive analysis||||||0.014|||||||t-test, 2 sided|paired t-test||Null hypothesis assumed||||0.014
72344555|NCT01192828|144212147|OTHER|Descriptive analysis||||||0.012|||||||t-test, 2 sided|paired t-test||Null hypothesis assumed||||0.012
72344556|NCT01192828|144212148|OTHER|Descriptive analysis.||||||0.16|||||||t-test, 2 sided|paired t-test||Null hypothesis applied.||||0.160
72344557|NCT01192828|144212149|OTHER|Descriptive analysis||||||0.1|||||||t-test, 2 sided|||||||0.10
72344558|NCT00590577|144212150|SUPERIORITY_OR_OTHER||Difference in least-squares means|-9.8|STANDARD_ERROR_OF_MEAN|2.0|<|0.001||95.0|-13.71|-5.85||Used analysis of covariance model with treatment (placebo, paliperidone palmitate 25, 100, 150 mg eq.) and country as factors and baseline value as a covariate. P-values adjusted for multiplicity for comparison with placebo using Dunnett's test.|ANCOVA||The 95% confidence intervals were unadjusted for multiplicity.|The overall type I error rate for testing all paliperidone palmitate doses vs. placebo for both the primary outcome and key secondary outcome was controlled at the 2-sided 0.05 significance level. The 2 families of hypotheses (in each family, comparison of each paliperidone palmitate dose vs. placebo) were tested using a parallel gatekeeping procedure that adjusts for multiplicity by using Dunnett's method in each family of hypotheses and using Bonferroni's inequality between different families.||-5.85|-13.71|<0.001
72344559|NCT00590577|144212150|SUPERIORITY_OR_OTHER||Difference in least-squares means|-8.7|STANDARD_ERROR_OF_MEAN|2.0|<|0.001||95.0|-12.62|-4.78||Used analysis of covariance model with treatment (placebo, paliperidone palmitate 25, 100, 150 mg eq.) and country as factors and baseline value as a covariate. P-values adjusted for multiplicity for comparison with placebo using Dunnett's test.|ANCOVA||The 95% confidence intervals were unadjusted for multiplicity.|The overall type I error rate for testing all paliperidone palmitate doses vs. placebo for both the primary outcome and key secondary outcome was controlled at the 2-sided 0.05 significance level. The 2 families of hypotheses (in each family, comparison of each paliperidone palmitate dose vs. placebo) were tested using a parallel gatekeeping procedure that adjusts for multiplicity by using Dunnett's method in each family of hypotheses and using Bonferroni's inequality between different families.||-4.78|-12.62|<0.001
72370159|NCT02028208|144250663|OTHER|Concordance between 0.30 mg/cm2 palladium and 1.0% palladium chloride in petrolatum|Kappa statistic|0.19|||||TWO_SIDED|95.0|-0.02|0.39||||||Concordance between Investigational and Reference Allergen presented for allergen doses which met the minimum criteria of 70% with positive reactions.||0.39|-0.02|
72370160|NCT02028208|144250663|OTHER|Concordance between 0.60 mg/cm2 palladium and 3.0% sodium tetrachloropalladate in petrolatum|Kappa statistic|0.83|||||TWO_SIDED|95.0|0.5|1.0||||||Concordance between Investigational and Reference Allergen presented for allergen doses which met the minimum criteria of 70% with positive reactions.||1.00|0.50|
72370161|NCT02028208|144250663|OTHER||Kappa statistic|0.06|||||TWO_SIDED|95.0|-0.05|0.17||||Concordance between 0.60 mg/cm2 palladium and 1.0 palladium chloride in petrolatum||Concordance between Investigational and Reference Allergen presented for allergen doses which met the minimum criteria of 70% with positive reactions.||0.17|-0.05|
72344560|NCT00590577|144212150|SUPERIORITY_OR_OTHER||Difference in least-squares means|-5.1|STANDARD_ERROR_OF_MEAN|2.01||0.034||95.0|-9.01|-1.1||Used analysis of covariance model with treatment (placebo, paliperidone palmitate 25, 100, 150 mg eq.) and country as factors and baseline value as a covariate. P-values adjusted for multiplicity for comparison with placebo using Dunnett's test.|ANCOVA||The 95% confidence intervals were unadjusted for multiplicity.|The overall type I error rate for testing all paliperidone palmitate doses vs. placebo for both the primary outcome and key secondary outcome was controlled at the 2-sided 0.05 significance level. The 2 families of hypotheses (in each family, comparison of each paliperidone palmitate dose vs. placebo) were tested using a parallel gatekeeping procedure that adjusts for multiplicity by using Dunnett's method in each family of hypotheses and using Bonferroni's inequality between different families.||-1.10|-9.01|0.034
72344561|NCT00590577|144212151|SUPERIORITY_OR_OTHER||Difference in least-squares means|6.2|STANDARD_ERROR_OF_MEAN|1.49|<|0.001||95.0|3.26|9.12||P-values were adjusted for multiplicity between PANSS total score (primary efficacy endpoint) and PSP, as well as different dose levels in comparison with placebo, using the Dunnett-Bonferroni-based parallel gatekeeping method.|ANCOVA||The 95% confidence intervals were unadjusted for multiplicity.|Analysis of the key secondary endpoint was conducted using an analysis of covariance model with treatment and country as factors, and the baseline PSP score as a covariate. The Dunnett-Bonferroni-based parallel gatekeeping approach was used to adjust for multiple testing.||9.12|3.26|<0.001
72344562|NCT00590577|144212151|SUPERIORITY_OR_OTHER||Difference in least-squares means|4.4|STANDARD_ERROR_OF_MEAN|1.5||0.007||95.0|1.43|7.31||P-values were adjusted for multiplicity between PANSS total score (primary efficacy endpoint) and PSP, as well as different dose levels in comparison with placebo, using the Dunnett-Bonferroni-based parallel gatekeeping method.|ANCOVA||The 95% confidence intervals were unadjusted for multiplicity.|Analysis of the key secondary endpoint was conducted using an analysis of covariance model with treatment and country as factors, and the baseline PSP score as a covariate. The Dunnett-Bonferroni-based parallel gatekeeping approach was used to adjust for multiple testing.||7.31|1.43|0.007
72344563|NCT00590577|144212151|SUPERIORITY_OR_OTHER||Difference in least-squares means|1.0|STANDARD_ERROR_OF_MEAN|1.5||0.509||95.0|-1.96|3.95||P-values were adjusted for multiplicity between PANSS total score (primary efficacy endpoint) and PSP, as well as different dose levels in comparison with placebo, using the Dunnett-Bonferroni-based parallel gatekeeping method.|ANCOVA||The 95% confidence intervals were unadjusted for multiplicity.|Analysis of the key secondary endpoint was conducted using an analysis of covariance model with treatment and country as factors, and the baseline PSP score as a covariate. The Dunnett-Bonferroni-based parallel gatekeeping approach was used to adjust for multiple testing.||3.95|-1.96|0.509
72344564|NCT00590577|144212152|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Comparisons with placebo were without multiplicity adjustment.|ANCOVA|||Analysis of the change in the CGI-S score at end point was performed using an analysis of covariance model on the ranks of the change in score at end point with treatment and country as factors, and (non-ranked) baseline CGI-S score as a covariate.||||<0.001
72344565|NCT00590577|144212152|SUPERIORITY_OR_OTHER|||||||0.005||95.0||||Comparisons with placebo were without multiplicity adjustment.|ANCOVA|||Analysis of the change in the CGI-S score at end point was performed using an analysis of covariance model on the ranks of the change in score at end point with treatment and country as factors, and (non-ranked) baseline CGI-S score as a covariate.||||0.005
72344566|NCT00590577|144212152|SUPERIORITY_OR_OTHER|||||||0.14||95.0||||Comparisons with placebo were without multiplicity adjustment.|ANCOVA|||Analysis of the change in the CGI-S score at end point was performed using an analysis of covariance model on the ranks of the change in score at end point with treatment and country as factors, and (non-ranked) baseline CGI-S score as a covariate.||||0.140
72428761|NCT04147260|144368589|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|-15.01|STANDARD_ERROR_OF_MEAN|8.106||0.071|TWO_SIDED|90.0|-31.34|1.33||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||1.33|-31.34|0.071
72344567|NCT00418574|144212162|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.099||||0.301|TWO_SIDED|95.0|0.919|1.315|||Regression, Cox|||||1.315|0.919|0.301
72344568|NCT04836247|144212179|SUPERIORITY||Mean Difference (Final Values)|1.63|||<|0.001|TWO_SIDED|||||\<.001 is calculated p-value in SPSS.|t-test, 2 sided|||||||<.001
72344569|NCT04836247|144212180|SUPERIORITY||Mean Difference (Final Values)|1.1|||<|0.001|TWO_SIDED|||||\<.001 is calculated p-value in SPSS.|t-test, 2 sided|||||||<.001
72344570|NCT04836247|144212181|SUPERIORITY||Mean Difference (Final Values)|2.61|||<|0.001|TWO_SIDED|||||\<.001 is calculated p-value in SPSS.|t-test, 2 sided|||||||<.001
72344571|NCT04836247|144212182|SUPERIORITY||Mean Difference (Final Values)|-0.12||||0.74|TWO_SIDED||||||t-test, 2 sided|||||||0.74
72344572|NCT04836247|144212183|SUPERIORITY||Mean Difference (Final Values)|-0.08||||0.76|TWO_SIDED||||||t-test, 2 sided|||||||0.76
72344573|NCT04836247|144212184|SUPERIORITY||Mean Difference (Final Values)|0.14||||0.44|TWO_SIDED||||||t-test, 2 sided|||||||0.44
72344574|NCT02726022|144212217|SUPERIORITY_OR_OTHER|||||||0.647|||||||Fisher Exact|||The statistical significance of change from baseline to EOT between gender status (male vs female) was tested using Fisher's exact test.||||0.647
72344575|NCT02726022|144212217|SUPERIORITY_OR_OTHER|||||||0.373|||||||Fisher Exact|||The statistical significance of change from baseline to EOT between drug addiction status (yes vs no) was tested using Fisher's exact test.||||0.373
72344576|NCT02726022|144212218|SUPERIORITY_OR_OTHER|||||||0.049|||||||Fisher Exact|||The statistical significance of change from baseline to 24 weeks after EOT between gender status (male vs female) was tested using Fisher's exact test.||||0.049
72344577|NCT02726022|144212218|SUPERIORITY_OR_OTHER|||||||0.86|||||||Fisher Exact|||The statistical significance of change from baseline to 24 weeks after EOT between drug addiction status (yes vs no) was tested using Fisher's exact test.||||0.860
72344578|NCT02726022|144212219|SUPERIORITY_OR_OTHER|||||||0.921|||||||Fisher Exact|||The statistical significance of change from baseline to EOT between gender status (male vs female) was tested using Fisher's exact test.||||0.921
72344579|NCT02726022|144212219|SUPERIORITY_OR_OTHER|||||||0.962|||||||Fisher Exact|||The statistical significance of change from baseline to EOT between drug addiction status (yes vs no) was tested using Fisher's exact test.||||0.962
72344580|NCT02726022|144212220|SUPERIORITY_OR_OTHER|||||||0.052|||||||Fisher Exact|||The statistical significance of change from baseline to 24 weeks after EOT between gender status (male vs female) was tested using Fisher's exact test.||||0.052
72344581|NCT02726022|144212220|SUPERIORITY_OR_OTHER|||||||0.677|||||||Fisher Exact|||The statistical significance of change from baseline to 24 weeks after EOT between drug addiction status (yes vs no) was tested using Fisher's exact test.||||0.677
72344582|NCT02726022|144212221|SUPERIORITY_OR_OTHER|||||||0.72|||||||Fisher Exact|||The statistical significance of change from baseline to EOT between gender status (male vs female) was tested using Fisher's exact test.||||0.720
72344583|NCT02726022|144212221|SUPERIORITY_OR_OTHER|||||||0.237|||||||Fisher Exact|||The statistical significance of change from baseline to EOT between drug addiction status (yes vs no) was tested using Fisher's exact test.||||0.237
72344584|NCT02726022|144212222|SUPERIORITY_OR_OTHER|||||||0.184|||||||Fisher Exact|||The statistical significance of change from baseline to 24 weeks after EOT between gender status (male vs female) was tested using Fisher's exact test.||||0.184
72344585|NCT02726022|144212222|SUPERIORITY_OR_OTHER|||||||0.889|||||||Fisher Exact|||The statistical significance of change from baseline to 24 weeks after EOT between drug addiction status (yes vs no) was tested using Fisher's exact test.||||0.889
72344586|NCT03262441|144212228|OTHER||Slope|-0.00033|||||TWO_SIDED|95.0|-0.002|0.0014||||||||0.0014|-0.0020|
72428762|NCT04147260|144368589|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|-11.63|STANDARD_ERROR_OF_MEAN|10.664||0.281|TWO_SIDED|90.0|-33.13|9.86||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||9.86|-33.13|0.281
72344587|NCT03262441|144212229|OTHER||Slope|0.001|||||TWO_SIDED|95.0|-0.0036|0.0056||||||||0.0056|-0.0036|
72344588|NCT03262441|144212230|OTHER||Slope|0.0024|||||TWO_SIDED|95.0|-0.003|0.0078||||||||0.0078|-0.003|
72344589|NCT00559988|144212277|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.064||||0.732|TWO_SIDED|95.0|0.75|1.51|||Regression, Cox|||||1.51|0.75|0.732
72344590|NCT01455194|144212287|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.122|STANDARD_ERROR_OF_MEAN|0.1175||0.2988|TWO_SIDED|95.0|-0.353|0.109|||ANCOVA|||Least square (LS) mean difference were derived from an ANCOVA model with baseline ACQ and age as covariates, and treatment, centre pool, sex, and prestudy ICS dose as factors.||0.109|-0.353|0.2988
72344591|NCT01455194|144212287|SUPERIORITY_OR_OTHER||LS Mean Difference|0.034|STANDARD_ERROR_OF_MEAN|0.118||0.7741|TWO_SIDED|95.0|-0.198|0.266|||ANCOVA|||Least square (LS) mean difference were derived from an ANCOVA model with baseline ACQ and age as covariates, and treatment, centre pool, sex, and prestudy ICS dose as factors.||0.266|-0.198|0.7741
72344592|NCT01455194|144212287|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.156|STANDARD_ERROR_OF_MEAN|0.1172||0.1835|TWO_SIDED|95.0|-0.387|0.074|||ANCOVA|||Least square (LS) mean difference were derived from an ANCOVA model with baseline ACQ and age as covariates, and treatment, centre pool, sex, and prestudy ICS dose as factors.||0.074|-0.387|0.1835
72344593|NCT01455194|144212289|SUPERIORITY_OR_OTHER||Hodges-Lehmann point estimate|0.0||||0.8465|TWO_SIDED|95.0|-3.0|4.0|||Wilcoxon (Mann-Whitney)||Treatment comparisons were carried out using an exact Wilcoxon Mann Whitney test.|||4.000|-3.000|0.8465
72344594|NCT01455194|144212289|SUPERIORITY_OR_OTHER||Hodges-Lehmann point estimate|1.0||||0.4175|TWO_SIDED|95.0|-2.0|5.0|||Wilcoxon (Mann-Whitney)||Treatment comparisons were carried out using an exact Wilcoxon Mann Whitney test.|||5.000|-2.000|0.4175
72344595|NCT01455194|144212290|SUPERIORITY_OR_OTHER|||||||0.4186|||||||Fisher Exact|||Well-controlled Asthma||||0.4186
72344596|NCT01455194|144212290|SUPERIORITY_OR_OTHER|||||||0.146|||||||Fisher Exact|||Well-controlled Asthma||||0.1460
72344597|NCT01455194|144212290|SUPERIORITY_OR_OTHER|||||||0.6017|||||||Fisher Exact|||Well-controlled Asthma||||0.6017
72344598|NCT01455194|144212290|SUPERIORITY_OR_OTHER|||||||0.3305|||||||Fisher Exact|||ACQ Improvement||||0.3305
72344599|NCT01455194|144212290|SUPERIORITY_OR_OTHER|||||||0.486|||||||Fisher Exact|||ACQ Improvement||||0.4860
72344600|NCT01455194|144212290|SUPERIORITY_OR_OTHER|||||||0.8922|||||||Fisher Exact|||ACQ Improvement||||0.8922
72344601|NCT01455194|144212291|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.042|STANDARD_ERROR_OF_MEAN|0.0806||0.6062|TWO_SIDED|95.0|0.89|1.221|||Log Rank||A hazard ratio of \>1 represented a benefit for the test treatment.|Well-controlled Asthma||1.221|0.890|0.6062
72344602|NCT01455194|144212291|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.05|STANDARD_ERROR_OF_MEAN|0.0669||0.4674|TWO_SIDED|95.0|0.921|1.197|||Log Rank||A hazard ratio of \>1 represented a benefit for the test treatment.|ACQ Improvement||1.197|0.921|0.4674
72344603|NCT01455194|144212291|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.201|STANDARD_ERROR_OF_MEAN|0.1597||0.2523|TWO_SIDED|95.0|0.878|1.642|||Log Rank||A hazard ratio of \>1 represented a benefit for the test treatment.|Well-controlled Asthma||1.642|0.878|0.2523
72344604|NCT01455194|144212291|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.913|STANDARD_ERROR_OF_MEAN|0.1354||0.5026|TWO_SIDED|95.0|0.7|1.191|||Log Rank||A hazard ratio of \>1 represented a benefit for the test treatment.|ACQ Improvement||1.191|0.700|0.5026
72344605|NCT01455194|144212291|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.898|STANDARD_ERROR_OF_MEAN|0.156||0.4893|TWO_SIDED|95.0|0.661|1.219|||Log Rank||A hazard ratio of \>1 represented a benefit for the test treatment.|Well-controlled Asthma||1.219|0.661|0.4893
72344606|NCT01455194|144212291|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.181|STANDARD_ERROR_OF_MEAN|0.1351||0.2193|TWO_SIDED|95.0|0.906|1.538|||Log Rank||A hazard ratio of \>1 represented a benefit for the test treatment.|ACQ Improvement||1.538|0.906|0.2193
72344607|NCT01455194|144212292|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.058|STANDARD_ERROR_OF_MEAN|0.0917||0.5397|TWO_SIDED|95.0|0.884|1.266|||Log Rank||A hazard ratio of \>1 represented a benefit for the test treatment.|ACQ cut-off at 0.5||1.266|0.884|0.5397
72344608|NCT01455194|144212292|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.005|STANDARD_ERROR_OF_MEAN|0.0738||0.9458|TWO_SIDED|95.0|0.87|1.161|||Log Rank||A hazard ratio of \>1 represented a benefit for the test treatment.|ACQ cut-off at 1.0||1.161|0.870|0.9458
72344609|NCT01455194|144212292|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.026|STANDARD_ERROR_OF_MEAN|0.0708||0.7213|TWO_SIDED|95.0|0.893|1.178|||Log Rank||A hazard ratio of \>1 represented a benefit for the test treatment.|ACQ cut-off at 1.25||1.178|0.893|0.7213
72344610|NCT01455194|144212292|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.05|STANDARD_ERROR_OF_MEAN|0.0692||0.4807|TWO_SIDED|95.0|0.917|1.202|||Log Rank||A hazard ratio of \>1 represented a benefit for the test treatment.|ACQ cut-off at 1.5||1.202|0.917|0.4807
72344611|NCT01455194|144212292|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.326|STANDARD_ERROR_OF_MEAN|0.1791||0.115|TWO_SIDED|95.0|0.934|1.884|||Log Rank||A hazard ratio of \>1 represented a benefit for the test treatment.|ACQ cut-off at 0.5||1.884|0.934|0.1150
72344612|NCT01455194|144212292|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.074|STANDARD_ERROR_OF_MEAN|0.1467||0.6281|TWO_SIDED|95.0|0.805|1.431|||Log Rank||A hazard ratio of \>1 represented a benefit for the test treatment.|ACQ cut-off at 1.0||1.431|0.805|0.6281
72344613|NCT01455194|144212292|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.059|STANDARD_ERROR_OF_MEAN|0.1415||0.6853|TWO_SIDED|95.0|0.803|1.397|||Log Rank||A hazard ratio of \>1 represented a benefit for the test treatment.|ACQ cut-off at 1.25||1.397|0.803|0.6853
72344614|NCT01455194|144212292|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.055|STANDARD_ERROR_OF_MEAN|0.1388||0.6995|TWO_SIDED|95.0|0.804|1.385|||Log Rank||A hazard ratio of \>1 represented a benefit for the test treatment.|ACQ cut-off at 1.5||1.385|0.804|0.6995
72344615|NCT01455194|144212292|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.837|STANDARD_ERROR_OF_MEAN|0.1744||0.308|TWO_SIDED|95.0|0.595|1.178|||Log Rank||A hazard ratio of \>1 represented a benefit for the test treatment.|ACQ cut-off at 0.5||1.178|0.595|0.3080
72344616|NCT01455194|144212292|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.939|STANDARD_ERROR_OF_MEAN|0.1461||0.6645|TWO_SIDED|95.0|0.705|1.25|||Log Rank||A hazard ratio of \>1 represented a benefit for the test treatment.|ACQ cut-off at 1.0||1.250|0.705|0.6645
72344617|NCT01455194|144212292|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.992|STANDARD_ERROR_OF_MEAN|0.1408||0.9564|TWO_SIDED|95.0|0.753|1.308|||Log Rank||A hazard ratio of \>1 represented a benefit for the test treatment.|ACQ cut-off at 1.25||1.308|0.753|0.9564
72344618|NCT01455194|144212292|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.047|STANDARD_ERROR_OF_MEAN|0.1375||0.7367|TWO_SIDED|95.0|0.8|1.371|||Log Rank||A hazard ratio of \>1 represented a benefit for the test treatment.|ACQ cut-off at 1.5||1.371|0.800|0.7367
72344619|NCT01455194|144212293|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.367|STANDARD_ERROR_OF_MEAN|0.2583||0.2264|TWO_SIDED|95.0|0.824|2.267|||Log Rank||A hazard ratio of \<1 represented a benefit for the test treatment.|||2.267|0.824|0.2264
72344620|NCT01455194|144212293|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.102|STANDARD_ERROR_OF_MEAN|0.5001||0.1373|TWO_SIDED|95.0|0.789|5.602|||Log Rank||A hazard ratio of \<1 represented a benefit for the test treatment.|||5.602|0.789|0.1373
72344621|NCT01455194|144212293|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.882|STANDARD_ERROR_OF_MEAN|0.4365||0.7732|TWO_SIDED|95.0|0.375|2.074|||Log Rank||A hazard ratio of \<1 represented a benefit for the test treatment.|||2.074|0.375|0.7732
72428763|NCT04147260|144368590|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|-2.84|STANDARD_ERROR_OF_MEAN|5.37||0.599|TWO_SIDED|90.0|-13.69|8.0||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||8.00|-13.69|0.599
72344622|NCT01455194|144212294|SUPERIORITY_OR_OTHER|||||||0.288|||||||Fisher Exact|||||||0.2880
72344623|NCT01455194|144212294|SUPERIORITY_OR_OTHER|||||||0.2864|||||||Fisher Exact|||||||0.2864
72344624|NCT02249182|144212300|EQUIVALENCE|Equivalence was determined if the 90% confidence intervals (CI) were within the predefined equivalence boundaries of 50% to 200% for all age groups.|Percentage Geometric Mean Ratio|105.2|||||TWO_SIDED|90.0|90.61|122.13||||||AUCtau of GS-331007 for the 12 to \< 18 Years old group in the PK Lead-in Phase was compared against historical data collected in adult Phase 2/3 studies.||122.13|90.61|
72344625|NCT02249182|144212300|EQUIVALENCE|Equivalence was determined if the 90% CIs were within the predefined equivalence boundaries of 50% to 200% for all age groups.|Percentage Geometric Mean Ratio|65.76|||||TWO_SIDED|90.0|56.62|76.37||||||AUCtau of GS-331007 for the 6 to \< 12 Years Old group in the PK Lead-in Phase was compared against historical data collected in adult Phase 2/3 studies.||76.37|56.62|
72344626|NCT02249182|144212300|EQUIVALENCE|Equivalence was determined if the 90% CIs were within the predefined equivalence boundaries of 50% to 200% for all age groups.|Percentage Geometric Mean Ratio|94.08|||||TWO_SIDED|90.0|82.51|107.27||||||AUCtau of GS-331007 for the 3 to \< 6 Years Old group in the PK Lead-in Phase was compared against historical data collected in adult Phase 2/3 studies.||107.27|82.51|
72344627|NCT02249182|144212300|EQUIVALENCE|Equivalence was determined if the 90% CIs were within the predefined equivalence boundaries of 50% to 200% for all age groups.|Percentage Geometric Mean Ratio|127.18|||||TWO_SIDED|90.0|94.89|170.45||||||AUCtau of LDV for the 12 to \< 18 Years Old group in the PK Lead-in Phase was compared against historical data collected in adult Phase 2/3 studies.||170.45|94.89|
72344628|NCT02249182|144212300|EQUIVALENCE|Equivalence was determined if the 90% CIs were within the predefined equivalence boundaries of 50% to 200% for all age groups.|Percentage Geometric Mean Ratio|82.25|||||TWO_SIDED|90.0|61.34|110.3||||||AUCtau of LDV for the 6 to \< 12 Years Old group in the PK Lead-in Phase was compared against historical data collected in adult Phase 2/3 studies.||110.30|61.34|
72344629|NCT02249182|144212300|EQUIVALENCE|Equivalence was determined if the 90% CIs were within the predefined equivalence boundaries of 50% to 200% for all age groups.|Percentage Geometric Mean Ratio|120.46|||||TWO_SIDED|90.0|93.18|155.73||||||AUCtau of LDV for the 3 to \< 6 Years Old group in the PK Lead-in Phase was compared against historical data collected in adult Phase 2/3 studies.||155.73|93.18|
72344630|NCT02249182|144212300|EQUIVALENCE|Equivalence was determined if the 90% CIs were within the predefined equivalence boundaries of 50% to 200% for all age groups.|Percentage Geometric Mean Ratio|159.88|||||TWO_SIDED|90.0|137.89|185.37||||||AUCtau of SOF for the 12 to \< 18 Years Old group in the PK Lead-in Phase was compared against historical data collected in adult Phase 2/3 studies.||185.37|137.89|
72344631|NCT02249182|144212300|EQUIVALENCE|Equivalence was determined if the 90% CIs were within the predefined equivalence boundaries of 50% to 200% for all age groups.|Percentage Geometric Mean Ratio|129.48|||||TWO_SIDED|90.0|110.79|151.32||||||AUCtau of SOF for the 6 to \< 12 Years Old group in the PK Lead-in Phase was compared against historical data collected in adult Phase 2/3 studies.||151.32|110.79|
72344632|NCT02249182|144212300|EQUIVALENCE|Equivalence was determined if the 90% CIs were within the predefined equivalence boundaries of 50% to 200% for all age groups.|Percentage Geometric Mean Ratio|187.76|||||TWO_SIDED|90.0|143.41|245.82||||||AUCtau of SOF for the 3 to \< 6 Years Old group in the PK Lead-in Phase was compared against historical data collected in adult Phase 2/3 studies.||245.82|143.41|
72344633|NCT00788710|144212333|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||ANOVA|||||||<0.001
72344634|NCT00788710|144212333|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||ANOVA|||||||<0.001
72344635|NCT00788710|144212334|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||ANOVA|||||||<0.001
72344636|NCT00788710|144212334|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||ANOVA|||||||<0.001
72344637|NCT00788710|144212335|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||ANOVA|||||||<0.001
72344638|NCT00788710|144212335|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||ANOVA|||||||<0.001
72344639|NCT00605345|144212348|NON_INFERIORITY_OR_EQUIVALENCE|"Non-inferiority was met if the lower limit of the confidence interval for the response rate of the CERA group was greater than the observed response rate of the darbepoetin group minus 15%. The calculated lower limit of an acceptable difference in response rates thus, was based on the actual percentage of responders in the darbepoetin group and this percentage minus 15% had to be excluded."||||||0.5947|||||||Fisher Exact|||||||0.5947
72344640|NCT01769196|144212357|SUPERIORITY|The null hypothesis was that there is no difference in PFS between simtuzumab and simtuzumab placebo. The alternative hypothesis was that there is a difference. These hypotheses were evaluated using stratified log-rank test, adjusted for screening post-bronchodilator FVC % predicted, sLOXL2 level categories and concomitant use of pirfenidone or nintedanib (P/N) at time of screening.|Hazard Ratio (HR)|1.13||||0.329|TWO_SIDED|95.0|0.88|1.45|||Log Rank||Hazard ratio was estimated from Cox regression model adjusted for treatment and stratified for screening post-bronchodilator FVC % predicted, sLOXL2 level categories, and concomitant pirfenidone/nintedanib use at time of screening.|||1.45|0.88|0.329
72344641|NCT01769196|144212358|SUPERIORITY|The null hypothesis was that there is no difference in PFS between simtuzumab and simtuzumab placebo in participants with sLOXL2 ≥ 50th percentile. The alternative hypothesis was that there is a difference. These hypotheses were evaluated using stratified log-rank test, adjusted for screening post-bronchodilator FVC % predicted and concomitant use of pirfenidone or nintedanib (P/N) at time of screening.|Hazard Ratio (HR)|1.03||||0.851|TWO_SIDED|95.0|0.74|1.43|||Log Rank||Hazard ratio was estimated from Cox regression model adjusted for treatment and stratified for screening post-bronchodilator FVC % predicted and concomitant pirfenidone/nintedanib use at time of screening.|||1.43|0.74|0.851
72344642|NCT01769196|144212359|SUPERIORITY|The null hypothesis was that there is no difference in PFS between simtuzumab and simtuzumab placebo in participants with sLOXL2 ≥ 75th percentile. The alternative hypothesis was that there is a difference. These hypotheses were evaluated using stratified log-rank test, adjusted for screening post-bronchodilator FVC % predicted and concomitant use of pirfenidone or nintedanib (P/N) at time of screening.|Hazard Ratio (HR)|1.2||||0.475|TWO_SIDED|95.0|0.72|2.0|||Log Rank||Hazard ratio was estimated from Cox regression model adjusted for treatment and stratified for screening post-bronchodilator FVC % predicted and concomitant pirfenidone/nintedanib use at time of screening.|||2.00|0.72|0.475
72344643|NCT01769196|144212360|OTHER||Hazard Ratio (HR)|1.2||||0.602|TWO_SIDED|95.0|0.61|2.37|||Log Rank||Hazard ratio was estimated from Cox regression model adjusted for treatment and stratified for screening post-bronchodilator FVC % predicted, sLOXL2 level categories, and concomitant pirfenidone/nintedanib use at time of screening.|||2.37|0.61|0.602
72344644|NCT01769196|144212361|OTHER|The difference in OS between the treatment groups was assessed using the stratified log-rank test, adjusted for screening post-bronchodilator FVC % predicted and concomitant use of pirfenidone or nintedanib (P/N) at time of screening.|Hazard Ratio (HR)|0.99||||0.988|TWO_SIDED|95.0|0.43|2.28|||Log Rank||Hazard ratio was estimated from Cox regression model adjusted for treatment and stratified for screening post-bronchodilator FVC % predicted and concomitant pirfenidone/nintedanib use at time of screening.|||2.28|0.43|0.988
72344645|NCT01769196|144212362|OTHER|The difference in OS between the treatment groups was assessed using the stratified log-rank test, adjusted for screening post-bronchodilator FVC % predicted and concomitant use of pirfenidone or nintedanib (P/N) at time of screening.|Hazard Ratio (HR)|0.95||||0.925|TWO_SIDED|95.0|0.3|2.99|||Log Rank||Hazard ratio was estimated from Cox regression model adjusted for treatment and stratified for screening post-bronchodilator FVC % predicted and concomitant pirfenidone/nintedanib use at time of screening.|||2.99|0.30|0.925
72344646|NCT00655629|144212372|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.92|||<|0.0001||95.0|-8.45|-5.38|||ANCOVA|||Power adjustment for 3 primary efficacy variables (3 variables have to be significant in favor of Vardenafil to conclude efficacy). Statistical analysis applies to the total population.||-5.38|-8.45|<0.0001
72344647|NCT00655629|144212373|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-25.972|||<|0.0001||95.0|-32.688|-19.256|||ANCOVA|||Statistical analysis applies to the total population.||-19.256|-32.688|<0.0001
72344648|NCT00655629|144212374|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-33.432|||<|0.0001||95.0|-40.439|-26.425|||ANCOVA|||Statistical analysis applies to the total population.||-26.425|-40.439|<0.0001
72344649|NCT00655629|144212375|SUPERIORITY_OR_OTHER||Cochran-Mantel-Haenszel|53.8693|||<|0.0001||95.0|||||Cochran-Mantel-Haenszel|CMH adjusted for age group and center||Statistical analysis applies to the total population.||||<0.0001
72344650|NCT00655629|144212376|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.078|||<|0.0001||95.0|-22.41|-9.746|||ANCOVA|||Statistical analysis applies to the total population.||-9.746|-22.41|<0.0001
72344651|NCT00655629|144212377|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-33.134|||<|0.0001||95.0|-40.281|-25.987|||ANCOVA|||Statistical analysis applies to the total population.||-25.987|-40.281|<0.0001
72344652|NCT00655629|144212378|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-33.934|||<|0.0001||95.0|-41.119|-26.749|||ANCOVA|||Statistical analysis applies to the total population.||-26.749|-41.119|<0.0001
72344653|NCT00655629|144212379|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-20.902|||<|0.0001||95.0|-27.724|-14.081|||ANCOVA|||Statistical analysis applies to the total population.||-14.081|-27.724|<0.0001
72344654|NCT00655629|144212381|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.866|||<|0.0001||95.0|-22.599|-11.133|||ANCOVA|||Statistical analysis applies to the total population.||-11.133|-22.599|<0.0001
72344655|NCT00655629|144212382|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-26.04|||<|0.0001||95.0|-31.547|-20.533|||ANCOVA|||Statistical analysis applies to the total population.||-20.533|-31.547|<0.0001
72344656|NCT00655629|144212383|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.496|||<|0.0001||95.0|-24.676|-14.315|||ANCOVA|||Statistical analysis applies to the total population.||-14.315|-24.676|<0.0001
72344657|NCT00655629|144212384|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-18.418|||<|0.0001||95.0|-24.439|-12.396|||ANCOVA|||Statistical analysis applies to the total population.||-12.396|-24.439|<0.0001
72344658|NCT00655629|144212385|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-22.379|||<|0.0001||95.0|-28.006|-16.753|||ANCOVA|||Statistical analysis applies to the total population.||-16.753|-28.006|<0.0001
72344659|NCT00655629|144212386|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-30.758|||<|0.0001||95.0|-36.736|-24.779|||ANOVA|||Statistical analysis applies to the total population.||-24.779|-36.736|<0.0001
72344660|NCT00655629|144212387|SUPERIORITY_OR_OTHER||Cochran-Mantel-Haenszel|60.2391|||<|0.0001||95.0|||||Cochran-Mantel-Haenszel|CMH adjusted for age group and center||Statistical analysis applies to the total population.||||<0.0001
72344661|NCT00098306|144212408|SUPERIORITY_OR_OTHER||LS mean difference|-0.788|STANDARD_ERROR_OF_MEAN|0.1571|||TWO_SIDED|97.5|-1.141|-0.435||||||The difference between the treatment least square means (LS means) adjusted for the randomization strata was presented in addition to 2-sided 97.5% confidence interval (CI) as an adjustment for multiplicity using a Bonferroni correction. Negative value favors maraviroc over placebo.||-0.435|-1.141|
72344662|NCT00098306|144212408|SUPERIORITY_OR_OTHER||LS mean difference|-0.922|STANDARD_ERROR_OF_MEAN|0.1568|||TWO_SIDED|97.5|-1.275|-0.57||||||The difference between the treatment LS means adjusted for the randomization strata was presented in addition to 2-sided 97.5% CI as an adjustment for multiplicity using a Bonferroni correction. Negative value favors maraviroc over placebo.||-0.570|-1.275|
72344663|NCT00098306|144212409|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.88|||<|0.0001|TWO_SIDED|95.0|1.78|4.67|||Regression, Logistic|||Week 24: Two-sided 95% CI was presented for the odds ratios between treatment groups with placebo as the comparator. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (less than \[\<\] 100,000 or greater than or equal to \[\>=\] 100,000), enfuvirtide use (Yes or No) as covariates was used. Odds ratio greater than (\>) 1 favors maraviroc.||4.67|1.78|<0.0001
72344664|NCT00098306|144212409|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.66|||<|0.0001|TWO_SIDED|95.0|2.26|5.95|||Regression, Logistic|||Week 24: Two-sided 95% CI was presented for the odds ratios between treatment groups with placebo as the comparator. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (\<100,000 or \>=100,000), enfuvirtide use (Yes or No) as covariates was used. Odds ratio \>1 favors maraviroc.||5.95|2.26|<0.0001
72344665|NCT00098306|144212409|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.96|||<|0.0001|TWO_SIDED|95.0|2.36|6.64|||Regression, Logistic|||Week 48: Two-sided 95% CI was presented for the odds ratios between treatment groups with placebo as the comparator. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (\<100,000 or \>=100,000), enfuvirtide use (Yes or No) as covariates was used. Odds ratio \>1 favors maraviroc.||6.64|2.36|<0.0001
72344666|NCT00098306|144212409|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.11|||<|0.0001|TWO_SIDED|95.0|3.04|8.59|||Regression, Logistic|||Week 48: Two-sided 95% CI was presented for the odds ratios between treatment groups with placebo as the comparator. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (\<100,000 or \>=100,000), enfuvirtide use (Yes or No) as covariates was used. Odds ratio \>1 favors maraviroc.||8.59|3.04|<0.0001
72344667|NCT00098306|144212410|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.6|||<|0.0001|TWO_SIDED|95.0|1.63|4.13|||Regression, Logistic|||Week 24: Two-sided 95% CI was presented for the odds ratios between treatment groups with placebo as the comparator. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (\<100,000 or \>=100,000), enfuvirtide use (Yes or No) as covariates was used. Odds ratio \>1 favors maraviroc.||4.13|1.63|<0.0001
72344668|NCT00098306|144212410|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.85|||<|0.0001|TWO_SIDED|95.0|1.79|4.54|||Regression, Logistic|||Week 24: Two-sided 95% CI was presented for the odds ratios between treatment groups with placebo as the comparator. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (\<100,000 or \>=100,000), enfuvirtide use (Yes or No) as covariates was used. Odds ratio \>1 favors maraviroc.||4.54|1.79|<0.0001
72344669|NCT00098306|144212410|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.93|||<|0.0001|TWO_SIDED|95.0|1.83|4.67|||Regression, Logistic|||Week 48: Two-sided 95% CI was presented for the odds ratios between treatment groups with placebo as the comparator. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (\<100,000 or \>=100,000), enfuvirtide use (Yes or No) as covariates was used. Odds ratio \>1 favors maraviroc.||4.67|1.83|<0.0001
72344670|NCT00098306|144212410|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.33|||<|0.0001|TWO_SIDED|95.0|2.08|5.32|||Regression, Logistic|||Week 48: Two-sided 95% CI was presented for the odds ratios between treatment groups with placebo as the comparator. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (\<100,000 or \>=100,000), enfuvirtide use (Yes or No) as covariates was used. Odds ratio \>1 favors maraviroc.||5.32|2.08|<0.0001
72344671|NCT00098306|144212411|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.06|||<|0.0001|TWO_SIDED|95.0|1.92|4.88|||Regression, Logistic|||Week 24: Two-sided 95% CI was presented for the odds ratios between treatment groups with placebo as the comparator. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (\<100,000 or \>=100,000), enfuvirtide use (Yes or No) as covariates was used. Odds ratio \>1 favors maraviroc.||4.88|1.92|<0.0001
72344672|NCT00098306|144212411|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.55|||<|0.0001|TWO_SIDED|95.0|2.22|5.68|||Regression, Logistic|||Week 24: Two-sided 95% CI was presented for the odds ratios between treatment groups with placebo as the comparator. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (\<100,000 or \>=100,000), enfuvirtide use (Yes or No) as covariates was used. Odds ratio \>1 favors maraviroc.||5.68|2.22|<0.0001
72344673|NCT00098306|144212411|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.3|||<|0.0001|TWO_SIDED|95.0|2.05|5.31|||Regression, Logistic|||Week 48: Two-sided 95% CI was presented for the odds ratios between treatment groups with placebo as the comparator. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (\<100,000 or \>=100,000), enfuvirtide use (Yes or No) as covariates was used. Odds ratio \>1 favors maraviroc.||5.31|2.05|<0.0001
72344674|NCT00098306|144212411|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.03|||<|0.0001|TWO_SIDED|95.0|2.5|6.51|||Regression, Logistic|||Week 48: Two-sided 95% CI was presented for the odds ratios between treatment groups with placebo as the comparator. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (\<100,000 or \>=100,000), enfuvirtide use (Yes or No) as covariates was used. Odds ratio \>1 favors maraviroc.||6.51|2.50|<0.0001
72344675|NCT00098306|144212412|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.43||||0.0006|TWO_SIDED|95.0|1.46|4.04|||Regression, Logistic|||Week 24: Two-sided 95% CI was presented for the odds ratios between treatment groups with placebo as the comparator. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (\<100,000 or \>=100,000), enfuvirtide use (Yes or No) as covariates was used. Odds ratio \>1 favors maraviroc.||4.04|1.46|0.0006
72344676|NCT00098306|144212412|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.15|||<|0.0001|TWO_SIDED|95.0|1.9|5.23|||Regression, Logistic|||Week 24: Two-sided 95% CI was presented for the odds ratios between treatment groups with placebo as the comparator. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (\<100,000 or \>=100,000), enfuvirtide use (Yes or No) as covariates was used. Odds ratio \>1 favors maraviroc.||5.23|1.90|<0.0001
72344677|NCT00098306|144212412|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.1|||<|0.0001|TWO_SIDED|95.0|2.32|7.25|||Regression, Logistic|||Week 48: Two-sided 95% CI was presented for the odds ratios between treatment groups with placebo as the comparator. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (\<100,000 or \>=100,000), enfuvirtide use (Yes or No) as covariates was used. Odds ratio \>1 favors maraviroc.||7.25|2.32|<0.0001
72344678|NCT00098306|144212412|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.97|||<|0.0001|TWO_SIDED|95.0|2.82|8.77|||Regression, Logistic|||Week 48: Two-sided 95% CI was presented for the odds ratios between treatment groups with placebo as the comparator. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (\<100,000 or \>=100,000), enfuvirtide use (Yes or No) as covariates was used. Odds ratio \>1 favors maraviroc.||8.77|2.82|<0.0001
72344679|NCT00098306|144212414|SUPERIORITY_OR_OTHER||LS mean difference|54.49|STANDARD_ERROR_OF_MEAN|12.435|||TWO_SIDED|95.0|30.07|78.92||||||Week 24: The difference between the treatment LS means adjusted for the randomization strata was presented in addition to 2-sided 95% CI. Positive value favors maraviroc over placebo.||78.92|30.07|
72344680|NCT00098306|144212414|SUPERIORITY_OR_OTHER||LS mean difference|58.94|STANDARD_ERROR_OF_MEAN|12.378|||TWO_SIDED|95.0|34.63|83.26||||||Week 24: The difference between the treatment LS means adjusted for the randomization strata was presented in addition to 2-sided 95% CI. Positive value favors maraviroc over placebo.||83.26|34.63|
72344681|NCT00098306|144212414|SUPERIORITY_OR_OTHER||LS mean difference|58.56|STANDARD_ERROR_OF_MEAN|12.677|||TWO_SIDED|95.0|33.66|83.46||||||Week 48: The difference between the treatment LS means adjusted for the randomization strata was presented in addition to 2-sided 95% CI. Positive value favors maraviroc over placebo.||83.46|33.66|
72344682|NCT00098306|144212414|SUPERIORITY_OR_OTHER||LS mean difference|68.47|STANDARD_ERROR_OF_MEAN|12.617|||TWO_SIDED|95.0|43.69|93.25||||||Week 48: The difference between the treatment LS means adjusted for the randomization strata was presented in addition to 2-sided 95% CI. Positive value favors maraviroc over placebo.||93.25|43.69|
72344683|NCT00098306|144212415|SUPERIORITY_OR_OTHER||LS mean difference|284.21|STANDARD_ERROR_OF_MEAN|51.779|||TWO_SIDED|95.0|182.51|385.92||||||Week 24: The difference between the treatment LS means adjusted for the randomization strata was presented in addition to 2-sided 95% CI. Positive value favors maraviroc over placebo.||385.92|182.51|
72344684|NCT00098306|144212415|SUPERIORITY_OR_OTHER||LS mean difference|303.07|STANDARD_ERROR_OF_MEAN|51.507|||TWO_SIDED|95.0|201.9|404.23||||||Week 24: The difference between the treatment LS means adjusted for the randomization strata was presented in addition to 2-sided 95% CI. Positive value favors maraviroc over placebo.||404.23|201.90|
72344685|NCT00098306|144212415|SUPERIORITY_OR_OTHER||LS mean difference|213.34|STANDARD_ERROR_OF_MEAN|49.679|||TWO_SIDED|95.0|115.77|310.92||||||Week 48: The difference between the treatment LS means adjusted for the randomization strata was presented in addition to 2-sided 95% CI. Positive value favors maraviroc over placebo.||310.92|115.77|
72344686|NCT00098306|144212415|SUPERIORITY_OR_OTHER||LS mean difference|235.74|STANDARD_ERROR_OF_MEAN|49.416|||TWO_SIDED|95.0|138.68|332.8||||||Week 48: The difference between the treatment LS means adjusted for the randomization strata was presented in addition to 2-sided 95% CI. Positive value favors maraviroc over placebo.||332.80|138.68|
72344687|NCT00098306|144212416|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.45|||<|0.0001|TWO_SIDED|95.0|0.34|0.6|||Log Rank|||P-value was calculated using Log rank test controlling for the effect of the randomization strata. Hazard ratio calculated by fitting a Cox proportional hazards model including treatment group and randomization strata. Hazard ratio \<1 favors maraviroc.||0.60|0.34|<0.0001
72344688|NCT00098306|144212416|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.38|||<|0.0001|TWO_SIDED|95.0|0.28|0.5|||Log Rank|||P-value was calculated using Log rank test controlling for the effect of the randomization strata. Hazard ratio calculated by fitting a Cox proportional hazards model including treatment group and randomization strata. Hazard ratio \<1 favors maraviroc.||0.50|0.28|<0.0001
72344689|NCT00098306|144212417|SUPERIORITY_OR_OTHER||LS mean difference|-0.697|STANDARD_ERROR_OF_MEAN|0.1347|||TWO_SIDED|95.0|-0.961|-0.432||||||Week 24: The difference between the treatment LS means adjusted for the randomization strata was presented in addition to 2-sided 95% CI. Negative value favors maraviroc over placebo.||-0.432|-0.961|
72344690|NCT00098306|144212417|SUPERIORITY_OR_OTHER||LS mean difference|-0.802|STANDARD_ERROR_OF_MEAN|0.1344|||TWO_SIDED|95.0|-1.065|-0.538||||||Week 24: The difference between the treatment LS means adjusted for the randomization strata was presented in addition to 2-sided 95% CI. Negative value favors maraviroc over placebo.||-0.538|-1.065|
72428764|NCT04147260|144368590|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|0.99|STANDARD_ERROR_OF_MEAN|4.41||0.824|TWO_SIDED|90.0|-7.92|9.9||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||9.90|-7.92|0.824
72344691|NCT00098306|144212417|SUPERIORITY_OR_OTHER||LS mean difference|-0.767|STANDARD_ERROR_OF_MEAN|0.1497|||TWO_SIDED|95.0|-1.061|-0.474||||||Week 48: The difference between the treatment LS means adjusted for the randomization strata was presented in addition to 2-sided 95% CI. Negative value favors maraviroc over placebo.||-0.474|-1.061|
72344692|NCT00098306|144212417|SUPERIORITY_OR_OTHER||LS mean difference|-0.931|STANDARD_ERROR_OF_MEAN|0.1494|||TWO_SIDED|95.0|-1.225|-0.638||||||Week 48: The difference between the treatment LS means adjusted for the randomization strata was presented in addition to 2-sided 95% CI. Negative value favors maraviroc over placebo.||-0.638|-1.225|
72344693|NCT00098306|144212418|SUPERIORITY_OR_OTHER||LS mean difference|-0.853|STANDARD_ERROR_OF_MEAN|0.1621|||TWO_SIDED|97.5|-1.217|-0.489||||||The difference between the treatment LS means adjusted for the randomization strata was presented in addition to 2-sided 97.5% CI as an adjustment for multiplicity using a Bonferroni correction. Negative value favors maraviroc over placebo.||-0.489|-1.217|
72344694|NCT00098306|144212418|SUPERIORITY_OR_OTHER||LS mean difference|-1.021|STANDARD_ERROR_OF_MEAN|0.1618|||TWO_SIDED|97.5|-1.385|-0.658||||||The difference between the treatment LS means adjusted for the randomization strata was presented in addition to 2-sided 97.5% CI as an adjustment for multiplicity using a Bonferroni correction. Negative value favors maraviroc over placebo.||-0.658|-1.385|
72344695|NCT00820222|144212437|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.65||||0.36|TWO_SIDED|95.0|0.26|1.63|||Odds Ratio||The Odds Ratio is based on a logistic regression model. The P-value for the test of Odds Ratio is 1.|||1.63|0.26|0.360
72344696|NCT00820222|144212438|SUPERIORITY||Hazard Ratio (HR)|1.3||||0.021|TWO_SIDED|95.0|1.04|1.64|||Log Rank||A HR \> 1 indicates a higher risk for lapatinib+capecitabine compared with trastuzumab+capecitabine.|||1.64|1.04|0.021
72344697|NCT00820222|144212440|SUPERIORITY||Hazard Ratio (HR)|1.34||||0.095|TWO_SIDED|95.0|0.95|1.9|||Log Rank||A HR \> 1 indicates a higher risk for lapatinib+capecitabine compared with trastuzumab+capecitabine.|||1.90|0.95|0.095
72344698|NCT00820222|144212441|SUPERIORITY||Odds Ratio (OR)|0.7984||||0.2731|TWO_SIDED|95.0|0.5407|1.1771|||Fisher Exact|||Comparison for Overall Response (CR+PR)||1.1771|0.5407|0.2731
72344699|NCT00820222|144212442|SUPERIORITY||Odds Ratio (OR)|0.9016||||0.6106|TWO_SIDED|95.0|0.6315|1.2866|||Fisher Exact|||Comparison for Clinical Benefit||1.2866|0.6315|0.6106
72344700|NCT01336023|144212457|NON_INFERIORITY|"Non-inferiority of IDegLira vs. IDeg was confirmed when 95% confidence interval for the treatment differences for change in HbA1c lies entirely below 0.3%.~IDegLira minus IDeg"|Treatment Contrast|-0.47|||||TWO_SIDED|95.0|-0.58|-0.36|||ANCOVA||IDegLira minus IDeg|||-0.36|-0.58|
72428765|NCT04147260|144368590|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|-3.83|STANDARD_ERROR_OF_MEAN|5.973||0.525|TWO_SIDED|90.0|-15.9|8.23||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||8.23|-15.90|0.525
72344701|NCT01336023|144212457|SUPERIORITY|"Superiority of IDegLira over liraglutide was confirmed when the 95% confidence interval for the treatment difference for change in HbA1c lies entirely below 0%.~IDegLira minus Liraglutide"|Treatment contrast|-0.64|||||TWO_SIDED|95.0|-0.75|-0.53|||ANCOVA||IDegLira minus Liraglutide|||-0.53|-0.75|
72344702|NCT01122849|144212466|SUPERIORITY_OR_OTHER||Least Square (LS) Mean difference|-0.12||||0.5456|TWO_SIDED|95.0|-0.52|0.28||Between treatment p-values and confidence intervals|ANCOVA|||Comparison of Q1 at Day 7||0.28|-0.52|0.5456
72344703|NCT01122849|144212466|SUPERIORITY_OR_OTHER||LS mean difference|-0.34||||0.1029|TWO_SIDED|95.0|-0.75|0.07||Between treatment p-values and confidence intervals|ANCOVA|||Comparison of Q1 at Day 7||0.07|-0.75|0.1029
72344704|NCT01122849|144212466|SUPERIORITY_OR_OTHER||LS mean difference|0.22||||0.2879|TWO_SIDED|95.0|-0.19|0.62||Between treatment p-values and confidence intervals|ANCOVA|||Comparison of Q1 at Day 7||0.62|-0.19|0.2879
72344705|NCT01122849|144212466|SUPERIORITY_OR_OTHER||LS Mean Difference|0.06||||0.8213|TWO_SIDED|95.0|-0.45|0.56||Between treatment p-values and confidence intervals|ANCOVA|||Comparison for Q3 at Day 7||0.56|-0.45|0.8213
72344706|NCT01122849|144212466|SUPERIORITY_OR_OTHER||LS Mean difference|-0.24||||0.3457||95.0|-0.74|0.27||Between treatment p-values and confidence intervals|ANCOVA|||Comparison for Q3 at Day 7||0.27|-0.74|0.3457
72344707|NCT01122849|144212466|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3||||0.2364|TWO_SIDED|95.0|-0.2|0.79|||ANCOVA|||Comparison for Q3 at Day 7||0.79|-0.20|0.2364
72344708|NCT01122849|144212466|SUPERIORITY_OR_OTHER||LS Mean Difference|0.18||||0.3553|TWO_SIDED|95.0|-0.21|0.57||Between treatment p-values and confidence intervals|ANCOVA|||Comparison for Q17 at Day 7||0.57|-0.21|0.3553
72344709|NCT01122849|144212466|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.19||||0.3369|TWO_SIDED|95.0|-0.58|0.2||Between treatment p-values and confidence intervals|ANCOVA|||Comparison for Q17 at Day 7||0.20|-0.58|0.3369
72344710|NCT01122849|144212466|SUPERIORITY_OR_OTHER||LS Mean Difference|0.37||||0.0591|TWO_SIDED|95.0|-0.01|0.76||Between treatment p-values and confidence intervals|ANCOVA|||Comparison for Q17 at Day 7||0.76|-0.01|0.0591
72344711|NCT01122849|144212466|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.05||||0.7686|TWO_SIDED|95.0|-0.42|0.31||Between treatment p-values and confidence intervals.|ANCOVA|||Comparison of Q18 at Day 7||0.31|-0.42|0.7686
72344712|NCT01122849|144212466|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.46||||0.0151|TWO_SIDED|95.0|-0.83|-0.09|||ANCOVA|||Comparison of Q18 at Day 7||-0.09|-0.83|0.0151
72344713|NCT01122849|144212466|SUPERIORITY_OR_OTHER||LS Mean Difference|0.41||||0.0256|TWO_SIDED|95.0|0.05|0.77||Between treatment p-values and confidence intervals|ANCOVA|||Comparison of Q18 at Day 7||0.77|0.05|0.0256
72344714|NCT01122849|144212467|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.11||||0.5958|TWO_SIDED|95.0|-0.52|0.3||Between treatment p-values and confidence intervals|ANCOVA|||Comparison of Q1at Day 14||0.30|-0.52|0.5958
72344715|NCT01122849|144212467|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.31||||0.1429|TWO_SIDED|95.0|-0.73|0.11||Between treatment p-values and confidence intervals|ANCOVA|||Comparison of Q1 at Day 14||0.11|-0.73|0.1429
72344716|NCT01122849|144212467|SUPERIORITY_OR_OTHER||LS Mean Difference|0.2||||0.3348|TWO_SIDED|95.0|-0.21|0.62|||ANCOVA|||Comparison of Q1 at Day 14||0.62|-0.21|0.3348
72344717|NCT01122849|144212467|SUPERIORITY_OR_OTHER||LS Mean Difference|0.2||||0.4425||95.0|-0.32|0.72||Between treatment p-values and confidence intervals|ANCOVA|||Comparison of Q3 at Day 14||0.72|-0.32|0.4425
72344718|NCT01122849|144212467|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.19||||0.4795|TWO_SIDED|95.0|-0.71|0.34|||ANCOVA|||Comparison of Q3 at Day 14||0.34|-0.71|0.4795
72344719|NCT01122849|144212467|SUPERIORITY_OR_OTHER||LS Mean Difference|0.39||||0.1375|TWO_SIDED|95.0|-0.13|0.9||Between treatment p-values and confidence intervals|ANCOVA|||Comparison of Q3 at Day 14||0.90|-0.13|0.1375
72344720|NCT01122849|144212467|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.12||||0.575|TWO_SIDED|95.0|-0.56|0.31||Between treatment p-values and confidence intervals|ANCOVA|||Comparison of Q17 at Day 14||0.31|-0.56|0.5750
72344721|NCT01122849|144212467|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.48||||0.0337|TWO_SIDED|95.0|-0.92|-0.04||Between treatment p-values and confidence intervals|ANCOVA|||Comparison of Q17 at Day 14||-0.04|-0.92|0.0337
72344722|NCT01122849|144212467|SUPERIORITY_OR_OTHER||LS Mean Difference|0.35||||0.1061|TWO_SIDED|95.0|-0.08|0.79||Between treatment p-values and confidence intervals|ANCOVA|||Comparison of Q17 at Day 14||0.79|-0.08|0.1061
72344723|NCT01122849|144212467|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.08||||0.7092|TWO_SIDED|95.0|-0.5|0.34||Between treatment p-values and confidence intervals|ANCOVA|||Comparison of Q18 at Day 14||0.34|-0.50|0.7092
72344724|NCT01122849|144212467|SUPERIORITY_OR_OTHER||LS Mean difference|-0.49||||0.025|TWO_SIDED|95.0|-0.91|-0.06||Between treatment p-values and confidence intervals|ANCOVA|||Comparison of Q18 at Day14||-0.06|-0.91|0.0250
72344725|NCT01122849|144212467|SUPERIORITY_OR_OTHER||LS Mean Difference|0.41||||0.0503|TWO_SIDED|95.0|0.0|0.82||Between treatment p-values and confidence intervals|ANCOVA|||Comparison for Q18 at Day 14||0.82|0.00|0.0503
72344726|NCT01122849|144212468|SUPERIORITY_OR_OTHER||LS Mean Difference|0.84||||0.5462|TWO_SIDED|95.0|-1.92|3.59||Between treatment p-values and confidence intervals|ANCOVA|||Comparison for sleep problems at Day 7||3.59|-1.92|0.5462
72344727|NCT01122849|144212468|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.37||||0.0942|TWO_SIDED|95.0|-5.16|0.42||Between treatment p-values and confidence intervals.|ANCOVA|||Comparison for sleep problems at Day 7||0.42|-5.16|0.0942
72344728|NCT01122849|144212468|SUPERIORITY_OR_OTHER||LS Mean Difference|3.2||||0.0221|TWO_SIDED|95.0|0.48|5.93||Between treatment p-values and confidence intervals|ANCOVA|||Comparison of sleep problems at Day 7||5.93|0.48|0.0221
72344729|NCT01122849|144212468|SUPERIORITY_OR_OTHER||LS Mean difference|-0.72||||0.6731|TWO_SIDED|95.0|-4.11|2.68||Between treatment p-values and confidence intervals|ANCOVA|||Comparison of Sleep Time problems at Day 7||2.68|-4.11|0.6731
72344730|NCT01122849|144212468|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.57||||0.1354|TWO_SIDED|95.0|-5.98|0.83||Between treatment p-values and confidence intervals|ANCOVA|||Comparison for Sleep time problems at Day 7||0.83|-5.98|0.1354
72344731|NCT01122849|144212468|SUPERIORITY_OR_OTHER||LS Mean difference|1.86||||0.2722|TWO_SIDED|95.0|-1.5|5.21||Between treatment p-values and confidence intervals|ANCOVA|||Comparison of sleep time problems at Day 7||5.21|-1.50|0.2722
72344732|NCT01122849|144212468|SUPERIORITY_OR_OTHER||LS Mean difference|-0.71||||0.6195|TWO_SIDED|95.0|-3.55|2.14||Between treatment p-values and confidence intervals|ANCOVA|||Comparison for symptoms on walking in the morning at Day 7||2.14|-3.55|0.6195
72344733|NCT01122849|144212468|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.83||||0.0099|TWO_SIDED|95.0|-6.7|-0.96||Between treatment p-values and confidence intervals|ANCOVA|||Comparison at day 7 for symptoms for walking in the morning||-0.96|-6.70|0.0099
72344734|NCT01122849|144212468|SUPERIORITY_OR_OTHER||LS Mean Difference|3.12||||0.0298|TWO_SIDED|95.0|0.32|5.93||Between treatment p-values and confidence intervals|ANCOVA|||Comparison for symptoms on waking in the morning at Day 7||5.93|0.32|0.0298
72344735|NCT01122849|144212468|SUPERIORITY_OR_OTHER||LS Mean difference|-0.3||||0.7211|TWO_SIDED|95.0|-2.01|1.4||Between treatment p-values and confidence intervals|ANCOVA|||Comparison for practical problems at Day 7||1.40|-2.01|0.7211
72344736|NCT01122849|144212468|SUPERIORITY_OR_OTHER||LS Mean difference|-0.8||||0.35|TWO_SIDED|95.0|-2.51|0.9||Between treatment p-values and confidence intervals|ANCOVA|||Comparison for practical problems at Day 7||0.90|-2.51|0.3500
72344737|NCT01122849|144212468|SUPERIORITY_OR_OTHER||LS Mean difference|0.5||||0.5564|TWO_SIDED|95.0|-1.19|2.18||Between treatment p-values and confidence intervals|ANCOVA|||Comparison for practical problems at Day 7||2.18|-1.19|0.5564
72344738|NCT01122849|144212469|SUPERIORITY_OR_OTHER||LS Mean Difference|0.57||||0.6804|TWO_SIDED|95.0|-2.2|3.35||Between treatment p-values and confidence intervals.|ANCOVA|||Comparison for Sleep Problems at Day 14||3.35|-2.20|0.6804
72344739|NCT01122849|144212469|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.31||||0.3524|TWO_SIDED|95.0|-4.12|1.49||Between treatment p-values and confidence intervals|ANCOVA|||Comparison for sleep problems at Day 14||1.49|-4.12|0.3524
72344740|NCT01122849|144212469|SUPERIORITY_OR_OTHER||LS Mean Difference|1.89||||0.1739|TWO_SIDED|95.0|-0.86|4.63||Between treatment p-values and confidence intervals|ANCOVA|||Comparison for sleep problems at Day 14||4.63|-0.86|0.1739
72344741|NCT01122849|144212469|SUPERIORITY_OR_OTHER||LS Mean difference|1.98||||0.2463|TWO_SIDED|95.0|-1.41|5.36||Between treatment p-values and confidence intervals|ANCOVA|Between treatment p-values and confidence intervals||Comparison for Sleep time problems at Day 14||5.36|-1.41|0.2463
72344742|NCT01122849|144212469|SUPERIORITY_OR_OTHER||LS Mean difference|0.28||||0.8677|TWO_SIDED|95.0|-3.11|3.68|||ANCOVA|||Comparison for sleep time problems at Day 14||3.68|-3.11|0.8677
72344743|NCT01122849|144212469|SUPERIORITY_OR_OTHER||LS Mean Difference|1.7||||0.3136|TWO_SIDED|95.0|-1.65|5.04||Between treatment p-values and confidence intervals|ANCOVA|||Comparison for sleep time problems at Day 14||5.04|-1.65|0.3136
72344744|NCT01122849|144212469|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.14||||0.9183|TWO_SIDED|95.0|-2.93|2.65||Between treatment p-values and confidence intervals|ANCOVA|||Comparison for symptoms on waking in the morning at Day 14||2.65|-2.93|0.9183
72344745|NCT01122849|144212469|SUPERIORITY_OR_OTHER||LS Mean difference|-2.68||||0.0614|TWO_SIDED|95.0|-5.5|0.13||Between treatment p-values and confidence intervals|ANCOVA|||Comparison for symptoms on waking in the morning at Day 14||0.13|-5.50|0.0614
72344746|NCT01122849|144212469|SUPERIORITY_OR_OTHER||LS Mean Difference|2.54||||0.0695|TWO_SIDED|95.0|-0.21|5.29||Between treatment p-values and confidence intervals|ANCOVA|||Comparison for symptoms on waking in the morning at Day 14||5.29|-0.21|0.0695
72344747|NCT01122849|144212469|SUPERIORITY_OR_OTHER||LS Mean difference|0.54||||0.4947|TWO_SIDED|95.0|-1.03|2.1||Between treatment p-values and confidence intervals|ANCOVA|||Comparison for practical problems at Day14||2.10|-1.03|0.4947
72344748|NCT01122849|144212469|SUPERIORITY_OR_OTHER||LS Mean difference|0.15||||0.8454|TWO_SIDED|95.0|-1.42|1.72||Between treatment p-values and confidence intervals|ANCOVA|||Comparison for practical problems at Day 14||1.72|-1.42|0.8454
72344749|NCT01122849|144212469|SUPERIORITY_OR_OTHER||LS Mean difference|0.38||||0.6223|TWO_SIDED|95.0|-1.17|1.93||Between treatment p-values and confidence intervals|ANCOVA|||Comparison for practical problems at Day 14||1.93|-1.17|0.6223
72344750|NCT01122849|144212470|SUPERIORITY_OR_OTHER||LS Mean difference|-1.34||||0.4258|TWO_SIDED|95.0|-4.68|2.01||Between treatment p-values and confidence intervals|LS Mean Difference|||Comparison at Day 7||2.01|-4.68|0.4258
72344751|NCT01122849|144212470|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.05||||0.0764|TWO_SIDED|95.0|-6.43|0.33||Between treatment p-values and confidence intervals|ANCOVA|||Comparison at Day 7||0.33|-6.43|0.0764
72344752|NCT01122849|144212470|SUPERIORITY_OR_OTHER||LS Mean Difference|1.71||||0.2986|TWO_SIDED|95.0|-1.56|4.97||Between treatment p-values and confidence intervals|ANCOVA|||Comparison at Day 7||4.97|-1.56|0.2986
72344753|NCT01122849|144212471|SUPERIORITY_OR_OTHER||LS Mean Difference|1.12||||0.482|TWO_SIDED|95.0|-2.05|4.29||Between treatment p-values and confidence intervals|ANCOVA|||||4.29|-2.05|0.4820
72344754|NCT01122849|144212471|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.81||||0.2607|TWO_SIDED|95.0|-5.02|1.39||Between treatment p-values and confidence intervals|ANCOVA|||||1.39|-5.02|0.2607
72344755|NCT01122849|144212471|SUPERIORITY_OR_OTHER||LS Mean Difference|2.93||||0.0623|TWO_SIDED|95.0|-0.16|6.02||Between treatment p-values and confidence intervals|ANCOVA|||||6.02|-0.16|0.0623
72344756|NCT01122849|144212472|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.36||||0.5278|TWO_SIDED|95.0|-18.1|9.39||Between treatment p-values and confidence intervals|ANCOVA|||||9.39|-18.1|0.5278
72344757|NCT01122849|144212472|SUPERIORITY_OR_OTHER||LS Mean Difference|10.14||||0.1458|TWO_SIDED|95.0|-3.64|23.93||Between treatment p-values and confidence intervals|ANCOVA|||||23.93|-3.64|0.1458
72344758|NCT01122849|144212472|SUPERIORITY_OR_OTHER||LS Mean Difference|-14.5||||0.037|TWO_SIDED|95.0|-28.1|-0.91||Between treatment p-values and confidence intervals.|ANCOVA|||||-0.91|-28.1|0.0370
72344759|NCT01122849|144212473|SUPERIORITY_OR_OTHER||LS Mean Difference|-5.1||||0.4483|TWO_SIDED|95.0|-18.5|8.29|||ANCOVA|Between treatment p-values and confidence intervals||||8.29|-18.5|0.4483
72344760|NCT01122849|144212473|SUPERIORITY_OR_OTHER||LS Mean Difference|14.28||||0.0385|TWO_SIDED|95.0|0.79|27.77|||ANCOVA|Between treatment p-values and confidence intervals||||27.77|0.79|0.0385
72344761|NCT01122849|144212473|SUPERIORITY_OR_OTHER||LS Mean difference|-19.37||||0.0046|TWO_SIDED|95.0|-32.5|-6.23|||ANCOVA|Between treatment p-values and confidence intervals||||-6.23|-32.5|0.0046
72344762|NCT01122849|144212474|SUPERIORITY_OR_OTHER||LS Mean Difference|15.24||||0.0029|TWO_SIDED|95.0|5.45|25.02||Between treatment p-values and confidence intervals|ANCOVA|||||25.02|5.45|0.0029
72344763|NCT01122849|144212474|SUPERIORITY_OR_OTHER||LS Mean Difference|3.74||||0.4683|TWO_SIDED|95.0|-6.53|14.01||Between treatment p-values and confidence intervals|ANCOVA|||||14.01|-6.53|0.4683
72344764|NCT01122849|144212474|SUPERIORITY_OR_OTHER||LS Mean Difference|11.5||||0.0259|TWO_SIDED|95.0|1.44|21.55||Between treatment p-values and confidence intervals|ANCOVA|||||21.55|1.44|0.0259
72344765|NCT01122849|144212475|SUPERIORITY_OR_OTHER||LS Mean Difference|7.79||||0.1764|TWO_SIDED|95.0|-3.62|19.19||Between treatment p-values and confidence intervals|ANCOVA|||||19.19|-3.62|0.1764
72344766|NCT01122849|144212475|SUPERIORITY_OR_OTHER||LS Mean Difference|0.63||||0.9183|TWO_SIDED|95.0|-11.7|12.94||Between treatment p-values and confidence intervals|ANCOVA|||||12.94|-11.7|0.9183
72344767|NCT01122849|144212475|SUPERIORITY_OR_OTHER||LS Mean Difference|7.16||||0.2313||95.0|-4.7|19.01||Between treatment p-values and confidence intervals|ANCOVA|||||19.01|-4.70|0.2313
72344768|NCT01122849|144212476|SUPERIORITY_OR_OTHER||LS Mean difference|0.27||||0.1345|TWO_SIDED|95.0|-0.09|0.63||Between treatment p-values and confidence intervals|ANCOVA|||Comparison for Q2 at Day 7||0.63|-0.09|0.1345
72344769|NCT01122849|144212476|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.32||||0.0815|TWO_SIDED|95.0|-0.68|0.04||Between treatment p-values and confidence intervals|ANCOVA|||Comparison for Q2 at Day 7||0.04|-0.68|0.0815
72344770|NCT01122849|144212476|SUPERIORITY_OR_OTHER||LS Mean Difference|0.59||||0.0015|TWO_SIDED|95.0|0.24|0.94||Between treatment p-values and confidence intervals|ANCOVA|||Comparison for Q2 at Day 7||0.94|0.24|0.0015
72344771|NCT01122849|144212476|SUPERIORITY_OR_OTHER||LS mean differnence|-1.03||||0.0292||95.0|-1.96|-0.11||Between treatment p-values and confidence intervals|ANCOVA|||Comparison for Q4 at Day 7||-0.11|-1.96|0.0292
72344772|NCT01122849|144212476|SUPERIORITY_OR_OTHER||LS Mean difference|0.54||||0.2497|TWO_SIDED|95.0|-0.39|1.47||Between treatment p-values and confidence intervals|ANCOVA|||Comparison of Q4 at Day 7||1.47|-0.39|0.2497
72344773|NCT01122849|144212476|SUPERIORITY_OR_OTHER||LS Mean difference|-1.57||||0.0011|TWO_SIDED|95.0|-2.48|-0.66||Between treatment p-values and confidence intervals|ANCOVA|||Comparison for Q4 at Day 7||-0.66|-2.48|0.0011
72344774|NCT01122849|144212477|SUPERIORITY_OR_OTHER||LS Mean Difference|0.06||||0.8063|TWO_SIDED|95.0|-0.4|0.51||Between treatment p-values and confidence intervals|ANCOVA|||Comparison for Q2 at Day 14||0.51|-0.40|0.8063
72344775|NCT01122849|144212477|SUPERIORITY_OR_OTHER||LS Mean Differnence|-0.35||||0.1356|TWO_SIDED|95.0|-0.82|0.11||Between treatment p-values and confidence intervals|ANCOVA|||Comparison for Q2 at Day 14||0.11|-0.82|0.1356
72344776|NCT01122849|144212477|SUPERIORITY_OR_OTHER||LS mean Difference|0.41||||0.0786|TWO_SIDED|95.0|-0.05|0.87|||ANCOVA|||Comparison for Q2 at Day 14||0.87|-0.05|0.0786
72344777|NCT01122849|144212477|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.72||||0.1693|TWO_SIDED|95.0|-1.75|0.32||Between treatment p-values and confidence intervals|ANCOVA|||Comparisons for Q4 at Day 14||0.32|-1.75|0.1693
72344778|NCT01122849|144212477|SUPERIORITY_OR_OTHER||LS Mean difference|1.08||||0.0438|TWO_SIDED|95.0|0.03|2.13||Between treatment p-values and confidence intervals|ANCOVA|||Comparison for Q4 at Day 14||2.13|0.03|0.0438
72344779|NCT01122849|144212477|SUPERIORITY_OR_OTHER||LS Mean difference|-1.8||||0.0009|TWO_SIDED|95.0|-2.82|-0.78||Between treatment p-values and confidence intervals|ANCOVA|||Comparison for Q4 at Day 14||-0.78|-2.82|0.0009
72344780|NCT01122849|144212478|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.24||||0.1991|TWO_SIDED|95.0|-0.62|0.13||Between treatment p-values and confidence intervals|ANCOVA|||Comparison for Q2 at Day 7||0.13|-0.62|0.1991
72344781|NCT01122849|144212478|SUPERIORITY_OR_OTHER||LS Mean difference|-0.21||||0.2964|TWO_SIDED|95.0|-0.6|0.19||Between treatment p-values and confidence intervals|ANCOVA|||Comparison of Q2 at Day 7||0.19|-0.60|0.2964
72344782|NCT01122849|144212478|SUPERIORITY_OR_OTHER||LS mean difference|-0.04||||0.8495|TWO_SIDED|95.0|-0.42|0.35||Between treatment p-values and confidence intervals|ANCOVA|||Comparison of Q2 at Day 7||0.35|-0.42|0.8495
72344783|NCT01122849|144212478|SUPERIORITY_OR_OTHER||LS mean difference|1.35||||0.0381|TWO_SIDED|95.0|0.08|2.62||Between treatment p-values and confidence intervals|ANCOVA|||Comparison for Q4 at Day 7||2.62|0.08|0.0381
72344784|NCT01122849|144212478|SUPERIORITY_OR_OTHER||LS mean difference|0.54||||0.4005|TWO_SIDED|95.0|-0.74|1.82||Between treatment p-values and confidence intervals|ANCOVA|||Comparison of Q4 at Day 7||1.82|-0.74|0.4005
72344785|NCT01122849|144212478|SUPERIORITY_OR_OTHER||LS mean difference|0.81||||0.202|TWO_SIDED|95.0|-0.45|2.07||Between treatment p-values and confidence intervals|ANCOVA|||Comparison of Q4 at Day 7||2.07|-0.45|0.2020
72344786|NCT01122849|144212479|SUPERIORITY_OR_OTHER||LS Mean difference|-0.09||||0.5741|TWO_SIDED|95.0|-0.41|0.23||Between treatment p-values and confidence intervals|ANCOVA|||Comparison for Q2 at Day 14||0.23|-0.41|0.5741
72344787|NCT01122849|144212479|SUPERIORITY_OR_OTHER||LS Mean Difference|0.06||||0.6935|TWO_SIDED|95.0|-0.26|0.39||Between treatment p-values and confidence intervals|ANCOVA|||Comparison for Q2 at Day 14||0.39|-0.26|0.6935
72344788|NCT01122849|144212479|SUPERIORITY_OR_OTHER||LS mean difference|-0.15||||0.333|TWO_SIDED|95.0|-0.47|0.16||Between treatment p-values and confidence intervals.|ANCOVA|||Comparison of Q2 at Day 14||0.16|-0.47|0.3330
72344789|NCT01122849|144212479|SUPERIORITY_OR_OTHER||LS Mean difference|1.39||||0.0434|TWO_SIDED|95.0|0.04|2.73||Between treatment p-values and confidence intervals|ANCOVA|||Comparison for Q4 at Day 14||2.73|0.04|0.0434
72344790|NCT01122849|144212479|SUPERIORITY_OR_OTHER||LS Mean difference|0.32||||0.6333|TWO_SIDED|95.0|-1.02|1.67||Between treatment p-values and confidence intervals|ANCOVA|||Comparison for Q4 at Day 14||1.67|-1.02|0.6333
72344791|NCT01122849|144212479|SUPERIORITY_OR_OTHER||LS mean difference|1.06||||0.1091|TWO_SIDED|95.0|-0.25|2.37||Between treatment p-values and confidence intervals.|ANCOVA|||Comparison for Q4 at Day 14||2.37|-0.25|0.1091
72344792|NCT03997825|144212497|SUPERIORITY|||||||0.001|||||||ANCOVA|||||||0.001
72344793|NCT03997825|144212498|SUPERIORITY|||||||0.001|||||||ANCOVA|||||||0.001
72344794|NCT00383162|144212504|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.5|||<|0.001||95.0|2.17|9.36|||Generalized Estimating Equations|||||9.36|2.17|<0.001
72344795|NCT00767819|144212523|SUPERIORITY|The lower limit of the confidence interval was used to support the decision in favor of p0 or p1: if the lower limit of the confidence interval overlapped p0, the hypothesis that p is greater than or equal to p1 could be rejected; on the other side, if the lower limit of the confidence interval excluded p0, the hypothesis that p is greater than or equal to p1 could be accepted.|percentage of participants|40.5||||0.1|TWO_SIDED|80.0|29.5|52.4|||Clopper-Person confidence interval|||||52.4|29.5|0.1
72344796|NCT00915551|144212557|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel|||||||<0.001
72344797|NCT00915551|144212558|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel|||||||<0.001
72344798|NCT00235716|144212559|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.15||||0.03|TWO_SIDED|95.0|0.92|5.39||p-value adjusted for 6 treatment group comparisons.|Mixed Models Analysis|Mixed effects model assuming data missing at random, adjusted for medical center as a random effect and for the baseline outcome score.|Mean difference is the least squares mean changes from baseline for the vitamin E group minus the placebo group.|Longitudinal analysis to assess the average treatment effect over 48 months with visits at 6, 12, 18, 24, 30, 36, 42 and 48 months using all available data.||5.39|0.92|0.03
72344799|NCT00235716|144212559|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.98||||0.4|TWO_SIDED|95.0|-0.24|4.2||p-value is adjusted for 6 treatment group comparisons|Mixed Models Analysis|Mixed effects model assuming data missing at random, adjusted for medical center as a random effect and for the baseline outcome score.|Mean difference is the least squares mean changes from baseline for the memantine group minus the placebo group.|Longitudinal analysis to assess the average treatment effect over 48 months with visits at 6, 12, 18, 24, 30, 36, 42 and 48 months using all available data.||4.20|-0.24|0.40
72344800|NCT00235716|144212559|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.76||||0.49|TWO_SIDED|95.0|-0.48|4.0||p-value is adjusted for 6 treatment group comparisons|Mixed Models Analysis|Mixed effects model assuming data missing at random, adjusted for medical center as a random effect and for the baseline outcome score.|Mean difference is the least squares mean changes from baseline for the vitamin E + memantine group minus the placebo group.|Longitudinal analysis to assess the average treatment effect over 48 months with visits at 6, 12, 18, 24, 30, 36, 42 and 48 months using all available data.||4.00|-0.48|0.49
72344801|NCT00235716|144212559|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.39||||0.6|TWO_SIDED|95.0|-3.63|0.85||p-value is adjusted for 6 treatment group comparisons|Mixed Models Analysis|Mixed effects model assuming data missing at random, adjusted for medical center as a random effect and for the baseline outcome score.|Mean difference is the least squares mean changes from baseline for the vitamin E + memantine group minus the vitamin E group.|Longitudinal analysis to assess the average treatment effect over 48 months with visits at 6, 12, 18, 24, 30, 36, 42 and 48 months using all available data.||0.85|-3.63|0.60
72344802|NCT00235716|144212559|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.22||||0.85|TWO_SIDED|95.0|-2.44|2.01||p-value is adjusted for 6 treatment group comparisons|Mixed Models Analysis|Mixed effects model assuming data missing at random, adjusted for medical center as a random effect and for the baseline outcome score.|Mean difference is the least squares mean changes from baseline for the vitamin E + memantine group minus the memantine group.|Longitudinal analysis to assess the average treatment effect over 48 months with visits at 6, 12, 18, 24, 30, 36, 42 and 48 months using all available data.||2.01|-2.44|0.85
72344803|NCT00235716|144212559|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.18||||0.6|TWO_SIDED|95.0|-1.04|3.39||p-value is adjusted for 6 treatment group comparisons|Mixed Models Analysis|Mixed effects model assuming data missing at random, adjusted for medical center as a random effect and for the baseline outcome score.|Mean difference is the least squares mean changes from baseline for the vitamin E group minus the memantine group.|Longitudinal analysis to assess the average treatment effect over 48 months with visits at 6, 12, 18, 24, 30, 36, 42 and 48 months using all available data.||3.39|-1.04|0.60
72344804|NCT00235716|144212560|SUPERIORITY_OR_OTHER|||||||0.69||||||p- value is unadjusted for multiple comparisons because its a 3 degrees of freedom test for any treatment group differences|Log Rank|3 degrees of freedom test||||||0.69
72428766|NCT04147260|144368590|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|-8.0|STANDARD_ERROR_OF_MEAN|6.867||0.25|TWO_SIDED|90.0|-21.84|5.84||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||5.84|-21.84|0.250
72344805|NCT00235716|144212561|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.19||||0.84|TWO_SIDED|95.0|-0.54|0.92||p-value is adjusted for 6 treatment group comparisons|Mixed Models Analysis|Mixed effects model assuming data missing at random, adjusted for medical center as a random effect and for the baseline outcome score.|Mean difference is the least squares mean changes from baseline for the vitamin E group minus the placebo group.|Longitudinal analysis to assess the average treatment effect over 48 months with visits at 6, 12, 18, 24, 30, 36, 42 and 48 months using all available data.||0.92|-0.54|0.84
72344806|NCT00235716|144212561|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.12||||0.84|TWO_SIDED|95.0|-0.61|0.84||p-value is adjusted for 6 treatment group comparisons|Mixed Models Analysis|Mixed effects model assuming data missing at random, adjusted for medical center as a random effect and for the baseline outcome score.|Mean difference is the least squares mean changes from baseline for the memantine group minus the placebo group.|Longitudinal analysis to assess the average treatment effect over 48 months with visits at 6, 12, 18, 24, 30, 36, 42 and 48 months using all available data.||0.84|-0.61|0.84
72344807|NCT00235716|144212561|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.37||||0.84|TWO_SIDED|95.0|-0.36|1.1||p-value is adjusted for 6 treatment group comparisons|Mixed Models Analysis|Mixed effects model assuming data missing at random, adjusted for medical center as a random effect and for the baseline outcome score.|Mean difference is the least squares mean changes from baseline for the vitamin E + memantine group minus the placebo group.|Longitudinal analysis to assess the average treatment effect over 48 months with visits at 6, 12, 18, 24, 30, 36, 42 and 48 months using all available data.||1.10|-0.36|0.84
72344808|NCT00235716|144212561|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.17||||0.84||95.0|-0.56|0.9||p-value is adjusted for 6 treatment group comparisons|Mixed Models Analysis|Mixed effects model assuming data missing at random, adjusted for medical center as a random effect and for the baseline outcome score.|Mean difference is the least squares mean changes from baseline for the vitamin E + memantine group minus the vitamin E group.|Longitudinal analysis to assess the average treatment effect over 48 months with visits at 6, 12, 18, 24, 30, 36, 42 and 48 months using all available data.||0.90|-0.56|0.84
72344809|NCT00235716|144212561|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.25||||0.84|TWO_SIDED|95.0|-0.47|0.98||p-value is adjusted for 6 treatment group comparisons|Mixed Models Analysis|Mixed effects model assuming data missing at random, adjusted for medical center as a random effect and for the baseline outcome score.|Mean difference is the least squares mean changes from baseline for the vitamin E + memantine group minus the memantine group.|Longitudinal analysis to assess the average treatment effect over 48 months with visits at 6, 12, 18, 24, 30, 36, 42 and 48 months using all available data.||0.98|-0.47|0.84
72344810|NCT00235716|144212561|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.08||||0.84|TWO_SIDED|95.0|-0.65|0.8||p-value is adjusted for 6 treatment group comparisons|Mixed Models Analysis|Mixed effects model assuming data missing at random, adjusted for medical center as a random effect and for the baseline outcome score.|Mean difference is the least squares mean changes from baseline for the vitamin E group minus the memantine group.|Longitudinal analysis to assess the average treatment effect over 48 months with visits at 6, 12, 18, 24, 30, 36, 42 and 48 months using all available data.||0.80|-0.65|0.84
72344811|NCT00235716|144212562|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.8||||0.1|TWO_SIDED|95.0|-3.28|-0.33||p-value is adjusted for 6 treatment group comparisons|Mixed Models Analysis|Mixed effects model assuming data missing at random, adjusted for medical center as a random effect and for the baseline outcome score.|Mean difference is the least squares mean changes from baseline for the vitamin E group minus the placebo group.|Longitudinal analysis to assess the average treatment effect over 48 months with visits at 6, 12, 18, 24, 30, 36, 42 and 48 months using all available data.||-0.33|-3.28|0.10
72344812|NCT00235716|144212562|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.39||||0.25|TWO_SIDED|95.0|-2.85|0.07||p-value is adjusted for 6 treatment group comparisons|Mixed Models Analysis|Mixed effects model assuming data missing at random, adjusted for medical center as a random effect and for the baseline outcome score.|Mean difference is the least squares mean changes from baseline for the memantine group minus the placebo group.|Longitudinal analysis to assess the average treatment effect over 48 months with visits at 6, 12, 18, 24, 30, 36, 42 and 48 months using all available data.||0.07|-2.85|0.25
72344813|NCT00235716|144212562|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.65||||0.14|TWO_SIDED|95.0|-3.12|-0.17||p-value is adjusted for 6 treatment group comparisons|Mixed Models Analysis|Mixed effects model assuming data missing at random, adjusted for medical center as a random effect and for the baseline outcome score.|Mean difference is the least squares mean changes from baseline for the vitamin E + memantine group minus the placebo group.|Longitudinal analysis to assess the average treatment effect over 48 months with visits at 6, 12, 18, 24, 30, 36, 42 and 48 months using all available data.||-0.17|-3.12|0.14
72344814|NCT00235716|144212562|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.15||||0.84|TWO_SIDED|95.0|-1.32|1.63||p-value is adjusted for 6 treatment group comparisons|Mixed Models Analysis|Mixed effects model assuming data missing at random, adjusted for medical center as a random effect and for the baseline outcome score.|Mean difference is the least squares mean changes from baseline for the vitamin E + memantine group minus the vitamin E group.|Longitudinal analysis to assess the average treatment effect over 48 months with visits at 6, 12, 18, 24, 30, 36, 42 and 48 months using all available data.||1.63|-1.32|0.84
72344815|NCT00235716|144212562|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.26||||0.84|TWO_SIDED|95.0|-1.72|1.21||p-value is adjusted for 6 treatment group comparisons|Mixed Models Analysis|Mixed effects model assuming data missing at random, adjusted for medical center as a random effect and for the baseline outcome score.|Mean difference is the least squares mean changes from baseline for the vitamin E + memantine group minus the memantine group.|Longitudinal analysis to assess the average treatment effect over 48 months with visits at 6, 12, 18, 24, 30, 36, 42 and 48 months using all available data.||1.21|-1.72|0.84
72428767|NCT04147260|144368590|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|5.19|STANDARD_ERROR_OF_MEAN|5.919||0.386|TWO_SIDED|90.0|-6.74|17.12||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||17.12|-6.74|0.386
72344816|NCT00235716|144212562|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.41||||0.84|TWO_SIDED|95.0|-1.88|1.06||p-value is adjusted for 6 treatment group comparisons|Mixed Models Analysis|Mixed effects model assuming data missing at random, adjusted for medical center as a random effect and for the baseline outcome score.|Mean difference is the least squares mean changes from baseline for the vitamin E group minus the memantine group.|Longitudinal analysis to assess the average treatment effect over 48 months with visits at 6, 12, 18, 24, 30, 36, 42 and 48 months using all available data.||1.06|-1.88|0.84
72344817|NCT00235716|144212563|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.46||||0.94|TWO_SIDED|95.0|-3.55|0.63||p-value is adjusted for 6 treatment group comparisons|Mixed Models Analysis|Mixed effects model assuming data missing at random, adjusted for medical center as a random effect and for the baseline outcome score.|Mean difference is the least squares mean changes from baseline for the vitamin E group minus the placebo group.|Longitudinal analysis to assess the average treatment effect over 48 months with visits at 6, 12, 18, 24, 30, 36, 42 and 48 months using all available data.||0.63|-3.55|0.94
72344818|NCT00235716|144212563|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.39||||0.94|TWO_SIDED|95.0|-2.47|1.7||p-value is adjusted for 6 treatment group comparisons|Mixed Models Analysis|Mixed effects model assuming data missing at random, adjusted for medical center as a random effect and for the baseline outcome score.|Mean difference is the least squares mean changes from baseline for the memantine group minus the placebo group.|Longitudinal analysis to assess the average treatment effect over 48 months with visits at 6, 12, 18, 24, 30, 36, 42 and 48 months using all available data.||1.70|-2.47|0.94
72344819|NCT00235716|144212563|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.47||||0.94|TWO_SIDED|95.0|-2.57|1.63||p-value is adjusted for 6 treatment group comparisons|Mixed Models Analysis|Mixed effects model assuming data missing at random, adjusted for medical center as a random effect and for the baseline outcome score.|Mean difference is the least squares mean changes from baseline for the vitamin E + memantine group minus the placebo group.|Longitudinal analysis to assess the average treatment effect over 48 months with visits at 6, 12, 18, 24, 30, 36, 42 and 48 months using all available data.||1.63|-2.57|0.94
72344820|NCT00235716|144212563|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.99||||0.94|TWO_SIDED|95.0|-1.09|3.07||p-value is adjusted for 6 treatment group comparisons|Mixed Models Analysis|Mixed effects model assuming data missing at random, adjusted for medical center as a random effect and for the baseline outcome score.|Mean difference is the least squares mean changes from baseline for the vitamin E + memantine group minus the vitamin E group.|Longitudinal analysis to assess the average treatment effect over 48 months with visits at 6, 12, 18, 24, 30, 36, 42 and 48 months using all available data.||3.07|-1.09|0.94
72344821|NCT00235716|144212563|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.08||||0.94|TWO_SIDED|95.0|-2.16|1.99||p-value is adjusted for 6 treatment group comparisons|Mixed Models Analysis|Mixed effects model assuming data missing at random, adjusted for medical center as a random effect and for the baseline outcome score.|Mean difference is the least squares mean changes from baseline for the vitamin E + memantine group minus the memantine group.|Longitudinal analysis to assess the average treatment effect over 48 months with visits at 6, 12, 18, 24, 30, 36, 42 and 48 months using all available data.||1.99|-2.16|0.94
72344822|NCT00235716|144212563|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.08||||0.94|TWO_SIDED|95.0|-3.14|0.99||p-value is adjusted for 6 treatment group comparisons|Mixed Models Analysis|Mixed effects model assuming data missing at random, adjusted for medical center as a random effect and for the baseline outcome score.|Mean difference is the least squares mean changes from baseline for the vitamin E group minus the memantine group.|Longitudinal analysis to assess the average treatment effect over 48 months with visits at 6, 12, 18, 24, 30, 36, 42 and 48 months using all available data.||0.99|-3.14|0.94
72344823|NCT00235716|144212564|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.79||||0.12|TWO_SIDED|95.0|-3.35|-0.23||p-value is adjusted for 6 treatment group comparisons|Mixed Models Analysis|Mixed effects model assuming data missing at random, adjusted for medical center as a random effect and for the baseline outcome score.|Mean difference is the least squares mean changes from baseline for the vitamin E group minus the placebo group.|Longitudinal analysis to assess the average treatment effect over 48 months with visits at 6, 12, 18, 24, 30, 36, 42 and 48 months using all available data.||-0.23|-3.35|0.12
72428768|NCT04147260|144368590|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|-13.19|STANDARD_ERROR_OF_MEAN|7.787||0.097|TWO_SIDED|90.0|-28.88|2.51||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||2.51|-28.88|0.097
72344824|NCT00235716|144212564|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.38||||0.86|TWO_SIDED|95.0|-1.18|1.94||p-value is adjusted for 6 treatment group comparisons|Mixed Models Analysis|Mixed effects model assuming data missing at random, adjusted for medical center as a random effect and for the baseline outcome score.|Mean difference is the least squares mean changes from baseline for the memantine group minus the placebo group.|Longitudinal analysis to assess the average treatment effect over 48 months with visits at 6, 12, 18, 24, 30, 36, 42 and 48 months using all available data.||1.94|-1.18|0.86
72344825|NCT00235716|144212564|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.14||||0.86|TWO_SIDED|95.0|-1.7|1.42||p-value is adjusted for 6 treatment group comparisons|Mixed Models Analysis|Mixed effects model assuming data missing at random, adjusted for medical center as a random effect and for the baseline outcome score.|Mean difference is the least squares mean changes from baseline for the vitamin E + memantine group minus the placebo group.|Longitudinal analysis to assess the average treatment effect over 48 months with visits at 6, 12, 18, 24, 30, 36, 42 and 48 months using all available data.||1.42|-1.70|0.86
72344826|NCT00235716|144212564|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.65||||0.14|TWO_SIDED|95.0|0.11|3.19||p-value is adjusted for 6 treatment group comparisons|Mixed Models Analysis|Mixed effects model assuming data missing at random, adjusted for medical center as a random effect and for the baseline outcome score.|Mean difference is the least squares mean changes from baseline for the vitamin E + memantine group minus the vitamin E group.|Longitudinal analysis to assess the average treatment effect over 48 months with visits at 6, 12, 18, 24, 30, 36, 42 and 48 months using all available data.||3.19|0.11|0.14
72344827|NCT00235716|144212564|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.52||||0.86|TWO_SIDED|95.0|-2.07|1.02||p-value is adjusted for 6 treatment group comparisons|Mixed Models Analysis|Mixed effects model assuming data missing at random, adjusted for medical center as a random effect and for the baseline outcome score.|Mean difference is the least squares mean changes from baseline for the vitamin E + memantine group minus the memantine group.|Longitudinal analysis to assess the average treatment effect over 48 months with visits at 6, 12, 18, 24, 30, 36, 42 and 48 months using all available data.||1.02|-2.07|0.86
72344828|NCT00235716|144212564|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.17||||0.03|TWO_SIDED|95.0|-3.71|-0.63||p-value is adjusted for 6 treatment group comparisons|Mixed Models Analysis|Mixed effects model assuming data missing at random, adjusted for medical center as a random effect and for the baseline outcome score.|Mean difference is the least squares mean changes from baseline for the vitamin E group minus the memantine group.|Longitudinal analysis to assess the average treatment effect over 48 months with visits at 6, 12, 18, 24, 30, 36, 42 and 48 months using all available data.||-0.63|-3.71|0.03
72344829|NCT00235716|144212565|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.87||||0.31|TWO_SIDED|95.0|0.67|1.13||p-value is unadjusted for multiple comparisons|Log Rank||Hazard ratio is for vitamin E group relative to the placebo group.|||1.13|0.67|0.31
72344830|NCT00235716|144212565|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.06||||0.47|TWO_SIDED|95.0|0.91|1.24||p-value is unadjusted for multiple comparisons|Log Rank||Hazard ratio is for the memantine group relative to the placebo group.|||1.24|0.91|0.47
72344831|NCT00235716|144212565|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.94||||0.8|TWO_SIDED|95.0|0.57|1.54||p-value is unadjusted for multiple comparisons|Log Rank||Hazard ratio is for the vitamin E + memantine group relative to the placebo group.|||1.54|0.57|0.80
72344832|NCT03036189|144212570|SUPERIORITY||Slope|-0.15||||0.5|TWO_SIDED||||||Mixed Models Analysis|||||||0.50
72344833|NCT03036189|144212571|SUPERIORITY||Slope|0.42||||0.71|TWO_SIDED||||||Mixed Models Analysis|||||||0.71
72344834|NCT03036189|144212572|SUPERIORITY||Slope|0.12||||0.83|TWO_SIDED||||||Mixed Models Analysis|||||||0.83
72344835|NCT03036189|144212573|SUPERIORITY||Slope|0.37||||0.58|TWO_SIDED||||||Mixed Models Analysis|||||||0.58
72344836|NCT03036189|144212574|SUPERIORITY||Slope|-0.4||||0.69|TWO_SIDED||||||Mixed Models Analysis|||||||0.69
72344837|NCT03036189|144212575|SUPERIORITY||Slope|0.49||||0.6|TWO_SIDED||||||Mixed Models Analysis|||||||0.60
72344838|NCT03036189|144212576|SUPERIORITY||Slope|-0.03||||0.97|TWO_SIDED||||||Mixed Models Analysis|||||||0.97
72344839|NCT03036189|144212577|SUPERIORITY||Slope|0.45||||0.49|TWO_SIDED||||||Mixed Models Analysis|||||||0.49
72344840|NCT03036189|144212578|SUPERIORITY||Slope|0.25||||0.77|TWO_SIDED||||||Mixed Models Analysis|||||||0.77
72344841|NCT03036189|144212579|SUPERIORITY||Slope|0.54|||<|0.05|TWO_SIDED||||||Mixed Models Analysis|||||||<.05
72344842|NCT03036189|144212580|SUPERIORITY||Slope|1.99||||0.4|TWO_SIDED||||||Mixed Models Analysis|||||||0.40
72344843|NCT03036189|144212581|SUPERIORITY||Slope|1.05||||0.07|TWO_SIDED||||||Mixed Models Analysis|||||||0.07
72344844|NCT03036189|144212582|SUPERIORITY||Slope|2.0||||0.84|TWO_SIDED||||||Mixed Models Analysis|||||||0.84
72344845|NCT03036189|144212583|SUPERIORITY||Slope|-23.01||||0.64|TWO_SIDED||||||Mixed Models Analysis|||||||0.64
72344846|NCT03274518|144212593|NON_INFERIORITY|The non-inferiority margin was defined as difference within 20% in comparison to reference method (olHDF)||||||0.4534|||||||t-test, 2 sided|||||||0.4534
72344847|NCT03274518|144212594|NON_INFERIORITY|The non-inferiority margin was defined as difference within 20% in comparison to reference method (olHDF)||||||0.1179|||||||t-test, 2 sided|||||||0.1179
72344848|NCT03274518|144212595|NON_INFERIORITY|The non-inferiority margin was defined as difference within 20% in comparison to reference method (olHDF)||||||0.3054|||||||t-test, 2 sided|||||||0.3054
72344849|NCT03274518|144212596|NON_INFERIORITY|The lower the ECW/TBW ratio, the lower pre-dialysis excess fluid. A non-inferiority margin was defined as difference within 10% from reference method (olHDF)||||||0.045|||||||t-test, 2 sided|||||||0.045
72344850|NCT03916484|144212607|OTHER|||||||0.33||||||No a priori threshold for statistical significance was specified.|Kruskal-Wallis|||||||0.33
72344851|NCT03916484|144212608|OTHER|||||||1|||||||Wilcoxon (Mann-Whitney)|||||||1.00
72344852|NCT03916484|144212608|OTHER|||||||0.43|||||||Wilcoxon (Mann-Whitney)|||||||0.43
72344853|NCT03916484|144212608|OTHER|||||||0.06|||||||Wilcoxon (Mann-Whitney)|||||||0.06
72344854|NCT03916484|144212608|OTHER|||||||0.06|||||||Wilcoxon (Mann-Whitney)|||||||0.06
72344855|NCT03916484|144212608|OTHER|||||||0.48|||||||Wilcoxon (Mann-Whitney)|||||||0.48
72344856|NCT03916484|144212609|OTHER|||||||0.45||||||No a priori threshold for statistical significance was specified.|Fisher Exact|||||||0.45
72344857|NCT03916484|144212610|OTHER||||||<|0.001|||||||McNemar|||||||<0.001
72344858|NCT03916484|144212610|OTHER|||||||0.07|||||||McNemar|||||||0.07
72344859|NCT03916484|144212610|OTHER|||||||0.003|||||||McNemar|||||||0.003
72344860|NCT03916484|144212611|OTHER|||||||0.25|||||||McNemar|||||||0.25
72344861|NCT03916484|144212611|OTHER|||||||0.002|||||||McNemar|||||||0.002
72344862|NCT03916484|144212611|OTHER|||||||0.453|||||||McNemar|||||||0.453
72344863|NCT03916484|144212611|OTHER|||||||0.5|||||||McNemar|||||||0.500
72344864|NCT03916484|144212611|OTHER|||||||0.003|||||||McNemar|||||||0.003
72344865|NCT01092663|144212652|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||t-test, 2 sided|unpaired t-test||Difference in treatment effect between the 2 groups||||>0.05
72344866|NCT01092663|144212653|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||t-test, 2 sided|unpaired t-test||Difference in treatment effect between the 2 groups||||>0.05
72344867|NCT01092663|144212654|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||t-test, 2 sided|unpaired t-test||Difference in treatment effects between the 2 groups||||>0.05
72344868|NCT01092663|144212655|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||t-test, 2 sided|unpaired t-test||Difference in treatment effect between the 2 groups||||>0.05
72344869|NCT01092663|144212656|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||t-test, 2 sided|unpaired t-test||Difference in treatment effect between the 2 groups||||>0.05
72344870|NCT01092663|144212657|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||t-test, 2 sided|unpaired t-test||Difference in treatment effect between the 2 groups||||<0.05
72344871|NCT01092663|144212658|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||t-test, 2 sided|unpaired t-test||Treament difference in fasting EGP between the 2 groups were compared.||||>0.05
72344872|NCT01092663|144212659|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||t-test, 2 sided|unpaired t-test||Difference in treatment effect between groups was evaluated||||>0.05
72344873|NCT01092663|144212660|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||t-test, 2 sided|unpaired ttest||Difference in treatment effect between groups was evaluated||||>0.05
72344874|NCT01092663|144212661|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||t-test, 2 sided|unpaired t-test||Difference in treatment effect between the 2 groups||||>0.05
72344875|NCT01092663|144212662|SUPERIORITY_OR_OTHER||||||=|0.01||95.0|||||t-test, 2 sided|unpaired t-test||Difference in treatment effect between the 2 groups||||=0.01
72344876|NCT01092663|144212663|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||t-test, 2 sided|unpaired t-test||differerences in treatment effect between the 2 groups||||>0.05
72344877|NCT01092663|144212664|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||t-test, 2 sided|unpaired t-test||Difference in treatment effect between the 2 groups||||>0.05
72344878|NCT01092663|144212665|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||t-test, 2 sided|unpaired t-test||Difference in treatment effect between the 2 groups||||>0.05
72344879|NCT01092663|144212666|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||t-test, 2 sided|unpaired t-test||Difference in treatment effect between the 2 groups||||>0.05
72344880|NCT01092663|144212667|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||t-test, 2 sided|unpaired t-test||Difference in treatment effect between the 2 groups||||>0.05
72344881|NCT01092663|144212668|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||t-test, 2 sided|unpaired t-test||Difference in treatment effect between the 2 groups||||<0.05
72428769|NCT04147260|144368591|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|0.99|STANDARD_ERROR_OF_MEAN|6.842||0.885|TWO_SIDED|90.0|-12.83|14.81||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||14.81|-12.83|0.885
72428770|NCT04147260|144368591|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|28.9|STANDARD_ERROR_OF_MEAN|5.619|<|0.001|TWO_SIDED|90.0|17.55|40.25||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||40.25|17.55|<0.001
72344882|NCT01092663|144212669|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||t-test, 2 sided|unpaired t-test||Difference in treatment effect between the 2 groups||||<0.05
72344883|NCT01092663|144212670|SUPERIORITY_OR_OTHER||||||<|0.01||95.0|||||t-test, 2 sided|unpaired t-test||Difference in treatment effect between the 2 groups||||<0.01
72344884|NCT01092663|144212671|SUPERIORITY_OR_OTHER||||||<|0.01||95.0|||||t-test, 2 sided|unpaired t-test||Difference in treatment effect between the 2 groups||||<0.01
72344885|NCT01092663|144212672|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||t-test, 2 sided|unpaired t-test||Difference in treatment effect between the 2 groups||||>0.05
72344886|NCT00781859|144212847|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.56||||0.003|TWO_SIDED|95.0|1.32|5.24||comparing placebo and ocriplasmin|Fisher Exact|||||5.24|1.32|0.003
72344887|NCT05546229|144212851|OTHER|||||||0.0049|||||||t-test, 2 sided|8 degrees of freedom||patient plasma versus isf value for methadone||||.0049
72344888|NCT05546229|144212852|OTHER|||||||0.0025|||||||t-test, 2 sided|8 degrees of freedom||||||.0025
72344889|NCT01220180|144212871|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||t-test, 2 sided|||||||<0.0001
72344890|NCT01220180|144212872|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||t-test, 2 sided|||||||<0.0001
72344891|NCT01220180|144212873|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||t-test, 2 sided|||||||<0.0001
72344892|NCT01220180|144212874|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||t-test, 2 sided|||||||<0.0001
72344893|NCT01220180|144212875|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||t-test, 2 sided|||||||<0.0001
72344894|NCT01220180|144212876|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||t-test, 2 sided|||||||<0.0001
72344895|NCT01220180|144212877|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||t-test, 2 sided|||||||<0.0001
72344896|NCT01220180|144212878|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||t-test, 2 sided|||||||<0.0001
72344897|NCT02713659|144212893|EQUIVALENCE|0.05||||||0.85|||||||t-test, 2 sided|||Auditory standard score between infants at 6 months and 24 months of age in the Early literacy arm and the standard literacy arm||||0.85
72344898|NCT02713659|144212893|EQUIVALENCE|0.05||||||0.53|||||||t-test, 2 sided|||Expressive standard score between infants at 6 months and 24 months of age in the Early literacy arm and the standard literacy arm||||0.53
72344899|NCT02713659|144212893|EQUIVALENCE|0.05||||||0.49|||||||t-test, 2 sided|||Total standard score between infants at 6 months and 24 months of age in the Early literacy arm and the standard literacy arm||||0.49
72344900|NCT02713659|144212894|EQUIVALENCE|0.05||||||0.57|||||||t-test, 2 sided|||Total read scale score between infants at 6 months and 24 months of age in the early literacy arm and the standard literacy arm||||0.57
72344901|NCT02713659|144212895|EQUIVALENCE|0.05||||||0.23|||||||Chi-squared|||Number of up to date child well visits between the early literacy arm and the standard literacy arm at 6 months of age||||0.23
72344902|NCT02713659|144212895|EQUIVALENCE|0.05||||||0.71|||||||Chi-squared|||Number of up to date child vaccinations between the early literacy arm and the standard literacy arm at 6 months of age||||0.71
72344903|NCT04943432|144212903|SUPERIORITY|||||||0.06|||||||t-test, 2 sided|||T2 - T1||||0.06
72344904|NCT04943432|144212903|SUPERIORITY|||||||0.68|||||||t-test, 2 sided|||T3 - T1||||0.68
72344905|NCT04943432|144212905|SUPERIORITY|||||||0.01|||||||t-test, 2 sided|||T2-T1||||.01
72344906|NCT04943432|144212905|SUPERIORITY|||||||0.32|||||||t-test, 2 sided|||T3-T1||||.32
72344907|NCT04943432|144212906|SUPERIORITY|||||||0.44|||||||t-test, 2 sided|||T2-T1||||.44
72344908|NCT04943432|144212906|SUPERIORITY|||||||0.007|||||||t-test, 2 sided|||T3-T1||||.007
72344909|NCT04943432|144212910|SUPERIORITY|||||||0.01|||||||t-test, 2 sided|||T2-T1||||.01
72344910|NCT04943432|144212910|SUPERIORITY|||||||0.11|||||||t-test, 2 sided|||T3-T1||||.11
72344911|NCT04943432|144212911|SUPERIORITY|||||||0.82|||||||t-test, 2 sided|||T2-T1||||.82
72344912|NCT04943432|144212911|SUPERIORITY|||||||0.36|||||||t-test, 2 sided|||T3-T1||||.36
72344913|NCT04943432|144212912|SUPERIORITY|||||||0.34|||||||t-test, 2 sided|||T2-T1||||.34
72344914|NCT04943432|144212912|SUPERIORITY|||||||0.02|||||||t-test, 2 sided|||T3-T1||||.02
72344915|NCT04943432|144212914|SUPERIORITY|||||||0.14|||||||t-test, 2 sided|||T2-T1||||.14
72344916|NCT04943432|144212914|SUPERIORITY|||||||0.29|||||||t-test, 2 sided|||T3-T1||||.29
72344917|NCT04943432|144212916|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||T2-T1||||<.001
72344918|NCT04943432|144212916|SUPERIORITY|||||||0.23|||||||t-test, 2 sided|||T3-T1||||.23
72344919|NCT01727414|144212944|SUPERIORITY|General linear mixed models were used to evaluate the subtype\*dose interaction to determine if the subtypes have unique MPH dose-response curves, with the outcome being Attention Deficit Hyperactivity Disorder total symptom scores (minimum=0, maximum=54, higher=worse)|Slope|0.29|||<|0.05|TWO_SIDED||||||Mixed Models Analysis|||||||<0.05
72344920|NCT02684188|144212979|SUPERIORITY|||||||0.03||||||P-values comparing the counts for the 2 groups after adjusting for PAM10.|Poisson regression|||H0: There is no difference in the cumulative number of hospital visits for day 3 (null hypothesis); H1: The cumulative number of hospital visits for the standard discharge group is greater than that for the enhanced discharge group for day 3.|For day 3, 112(68 baseline and 44 intervention) patients were used in this analysis.|||0.030
72428771|NCT04147260|144368591|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|-27.91|STANDARD_ERROR_OF_MEAN|7.61|<|0.001|TWO_SIDED|90.0|-43.28|-12.54||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||-12.54|-43.28|<0.001
72344921|NCT02684188|144212979|SUPERIORITY|||||||0.025||||||P-values comparing the counts for the 2 groups after adjusting for PAM10.|Poisson regression|||H0: There is no difference in the cumulative number of hospital visits for day 7 (null hypothesis); H1: The cumulative number of hospital visits for the standard discharge group is greater than that for the enhanced discharge group for day 7.|For day 7, 110 (66 baseline and 44 intervention) patients were used in this analysis.|||0.025
72344922|NCT02684188|144212979|SUPERIORITY|||||||0.037||||||P-values comparing the counts for the 2 groups after adjusting for PAM10.|Poisson regression|||H0: There is no difference in the cumulative number of hospital visits for day 14 (null hypothesis); H1: The cumulative number of hospital visits for the standard discharge group is greater than that for the enhanced discharge group for day 14.|For day 14, 104 (61 baseline and 43 intervention) patients were used in this analysis.|||0.037
72428772|NCT04147260|144368591|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|-20.13|STANDARD_ERROR_OF_MEAN|8.041||0.016|TWO_SIDED|90.0|-36.33|-3.92||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||-3.92|-36.33|0.016
72344923|NCT02684188|144212979|SUPERIORITY|||||||0.011||||||P-values comparing the counts for the 2 groups after adjusting for PAM10.|Poisson regression|||H0: There is no difference in the cumulative number of hospital visits for day 21 (null hypothesis); H1: The cumulative number of hospital visits for the standard discharge group is greater than that for the enhanced discharge group for day 21.|For day 21, 98 (57 baseline and 41 intervention) patients were used in this analysis.|||0.011
72344924|NCT02684188|144212979|SUPERIORITY|||||||0.05||||||P-values comparing the counts for the 2 groups after adjusting for PAM10.|Poisson regression|||H0: There is no difference in the cumulative number of hospital visits for day 30 (null hypothesis); H1: The cumulative number of hospital visits for the standard discharge group is greater than that for the enhanced discharge group for day 30.|For day 30, 95 (56 baseline and 39 intervention) patients were used in this analysis.|||0.050
72344925|NCT02684188|144212979|SUPERIORITY|||||||0.055|||||||Poisson regression|||H0: There is no difference in the cumulative number of hospital visits for day 60 (null hypothesis); H1: The cumulative number of hospital visits for the standard discharge group is greater than that for the enhanced discharge group for day 60.|For day 60, 87 (53 baseline and 34 intervention) patients were used in this analysis.|||0.055
72344926|NCT02684188|144212979|SUPERIORITY|||||||0.137||||||P-values comparing the counts for the 2 groups after adjusting for PAM10.|Poisson regression|||H0: There is no difference in the cumulative number of hospital visits for day 90 (null hypothesis); H1: The cumulative number of hospital visits for the standard discharge group is greater than that for the enhanced discharge group for day 90.|For day 90, 83 (49 baseline and 34 intervention) patients were used in this analysis.|||0.137
72344927|NCT02684188|144212980|SUPERIORITY|||||||0.279||||||P-values comparing the counts for the 2 groups after adjusting for PAM10.|Regression, Logistic|||H0: There is no difference in the proportion of patients with at least one ED visits by day 3 (null hypothesis); H1: The proportion of patients with at least one ED visit for the standard discharge group is greater than that for the enhanced discharge group for day 3.|For day 3, 112(68 baseline and 44 intervention) patients were used in this analysis.|||0.279
72428773|NCT04147260|144368591|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|18.5|STANDARD_ERROR_OF_MEAN|6.931||0.011|TWO_SIDED|90.0|4.53|32.46||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||32.46|4.53|0.011
72344928|NCT02684188|144212980|SUPERIORITY|||||||0.211||||||P-values comparing the counts for the 2 groups after adjusting for PAM10.|Regression, Logistic|||H0: There is no difference in the proportion of patients with at least one ED visits by day 7 (null hypothesis); H1: The proportion of patients with at least one ED visit for the standard discharge group is greater than that for the enhanced discharge group for day 7.|For day 7, 110 (66 baseline and 44 intervention) patients were used in this analysis.|||0.211
72344929|NCT02684188|144212980|SUPERIORITY|||||||0.424||||||P-values comparing the counts for the 2 groups after adjusting for PAM10.|Regression, Logistic|||H0: There is no difference in the proportion of patients with at least one ED visits by day 14 (null hypothesis); H1: The proportion of patients with at least one ED visit for the standard discharge group is greater than that for the enhanced discharge group for day 14.|For day 14, 104 (61 baseline and 43 intervention) patients were used in this analysis.|||0.424
72344930|NCT02684188|144212980|SUPERIORITY|||||||0.191||||||P-values comparing the counts for the 2 groups after adjusting for PAM10.|Regression, Logistic|||H0: There is no difference in the proportion of patients with at least one ED visits by day 21 (null hypothesis); H1: The proportion of patients with at least one ED visit for the standard discharge group is greater than that for the enhanced discharge group for day 21.|For day 21, 98 (57 baseline and 41 intervention) patients were used in this analysis.|||0.191
72344931|NCT02684188|144212980|SUPERIORITY|||||||0.478||||||P-values comparing the counts for the 2 groups after adjusting for PAM10.|Regression, Logistic|||H0: There is no difference in the proportion of patients with at least one ED visits by day 30 (null hypothesis); H1: The proportion of patients with at least one ED visit for the standard discharge group is greater than that for the enhanced discharge group for day 30.|For day 30, 95 (56 baseline and 39 intervention) patients were used in this analysis.|||0.478
72344932|NCT02684188|144212980|SUPERIORITY|||||||0.452||||||P-values comparing the counts for the 2 groups after adjusting for PAM10.|Regression, Logistic|||H0: There is no difference in the proportion of patients with at least one ED visits by day 60 (null hypothesis); H1: The proportion of patients with at least one ED visit for the standard discharge group is greater than that for the enhanced discharge group for day 60.|For day 60, 87 (53 baseline and 34 intervention) patients were used in this analysis.|||0.452
72344933|NCT02684188|144212980|SUPERIORITY|H0: There is no difference in the proportion of patients with at least one ED visits by day 90 (null hypothesis); H1: The proportion of patients with at least one ED visit for the standard discharge group is greater than that for the enhanced discharge group for day 90.||||||0.381||||||P-values comparing the counts for the 2 groups after adjusting for PAM10.|Regression, Logistic||||For day 90, 83 (49 baseline and 34 intervention) patients were used in this analysis.|||0.381
72344934|NCT02684188|144212981|SUPERIORITY|||||||0.502||||||P-values comparing the counts for the 2 groups after adjusting for PAM10.|Poisson regression|||H0: There is no difference in the cumulative number of hospital visits for day 3 (null hypothesis); H1: The cumulative number of hospital visits for the standard discharge group is greater than that for the enhanced discharge group for day 3.|For day 3, 115 (70 baseline and 45 intervention) patients were used in this analysis.|||0.502
72344935|NCT02684188|144212981|SUPERIORITY|||||||0.286||||||P-values comparing the counts for the 2 groups after adjusting for PAM10.|Poisson regression|||H0: There is no difference in the cumulative number of ED visits for day 7 (null hypothesis); H1: The cumulative number of ED visits for the standard discharge group is greater than that for the enhanced discharge group for day 7.|For day 7, 113 (68 baseline and 45 intervention) patients were used in this analysis.|||0.286
72344936|NCT02684188|144212981|SUPERIORITY|||||||0.347||||||P-values comparing the counts for the 2 groups after adjusting for PAM10.|Poisson regression|||H0: There is no difference in the cumulative number of ED visits for day 14 (null hypothesis); H1: The cumulative number of ED visits for the standard discharge group is greater than that for the enhanced discharge group for day 14.|For day 14, 107 (63 baseline and 44 intervention) patients were used in this analysis.|||0.347
72344937|NCT02684188|144212981|SUPERIORITY|||||||0.25||||||P-values comparing the counts for the 2 groups after adjusting for PAM10.|Poisson regression|||H0: There is no difference in the cumulative number of ED visits for day 21 (null hypothesis); H1: The cumulative number of ED visits for the standard discharge group is greater than that for the enhanced discharge group for day 21.|For day 21, 101 (59 baseline and 42 intervention) patients were used in this analysis.|||0.250
72344938|NCT02684188|144212981|SUPERIORITY|||||||0.22||||||P-values comparing the counts for the 2 groups after adjusting for PAM10.|Poisson regression|||H0: There is no difference in the cumulative number of ED visits for day 30 (null hypothesis); H1: The cumulative number of ED visits for the standard discharge group is greater than that for the enhanced discharge group for day 30.|For day 30, 98 (58 baseline and 40 intervention) patients were used in this analysis.|||0.220
72344939|NCT02684188|144212981|SUPERIORITY|||||||0.116||||||P-values comparing the counts for the 2 groups after adjusting for PAM10.|Poisson regression|||H0: There is no difference in the cumulative number of ED visits for day 60 (null hypothesis); H1: The cumulative number of ED visits for the standard discharge group is greater than that for the enhanced discharge group for day 60.|For day 60, 90 (55 baseline and 35 intervention) patients were used in this analysis.|||0.116
72344940|NCT02684188|144212981|SUPERIORITY|||||||0.126||||||P-values comparing the counts for the 2 groups after adjusting for PAM10.|Poisson regression|||H0: There is no difference in the cumulative number of ED visits for day 90 (null hypothesis); H1: The cumulative number of ED visits for the standard discharge group is greater than that for the enhanced discharge group for day 90.|For day 90, 86 (51 baseline and 35 intervention) patients were used in this analysis.|||0.126
72344941|NCT02684188|144212982|SUPERIORITY|||||||0.597||||||P-values comparing the counts for the 2 groups after adjusting for PAM10.|Regression, Logistic|||H0: There is no difference in the proportion of patients with at least one ED visits by day 3; H1: The proportion of patients with at least one ED visit for the standard discharge group is greater than that for the enhanced discharge group for day 3.|For day 3, 115 (70 baseline and 45 intervention) patients were used in this analysis.|||0.597
72428774|NCT04147260|144368591|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|-38.62|STANDARD_ERROR_OF_MEAN|9.118|<|0.001|TWO_SIDED|90.0|-57.0|-20.25||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||-20.25|-57.00|<0.001
72344942|NCT02684188|144212982|SUPERIORITY|||||||0.504||||||P-values comparing the counts for the 2 groups after adjusting for PAM10.|Regression, Logistic|||H0: There is no difference in the proportion of patients with at least one ED visits by day 7; H1: The proportion of patients with at least one ED visit for the standard discharge group is greater than that for the enhanced discharge group for day 7.|For day 7, 113 (68 baseline and 45 intervention) patients were used in this analysis.|||0.504
72344943|NCT02684188|144212982|SUPERIORITY|||||||0.558||||||P-values comparing the counts for the 2 groups after adjusting for PAM10.|Regression, Logistic|||H0: There is no difference in the proportion of patients with at least one ED visits by day 14; H1: The proportion of patients with at least one ED visit for the standard discharge group is greater than that for the enhanced discharge group for day 14.|For day 14, 107 (63 baseline and 44 intervention) patients were used in this analysis.|||0.558
72428775|NCT02204293|144368625|SUPERIORITY|Fisher's exact test with a two-tailed level of significance of α = 0.05.||||||0.1811|||||||Fisher Exact|||||||0.1811
72344944|NCT02684188|144212982|SUPERIORITY|||||||0.472||||||Comments (covariates): P-values comparing the counts for the 2 groups after adjusting for PAM10.|Regression, Logistic|||H0: There is no difference in the proportion of patients with at least one ED visits by day 21; H1: The proportion of patients with at least one ED visit for the standard discharge group is greater than that for the enhanced discharge group for day 21.|For day 21, 101 (59 baseline and 42 intervention) patients were used in this analysis.|||0.472
72344945|NCT02684188|144212982|SUPERIORITY|||||||0.462||||||P-values comparing the counts for the 2 groups after adjusting for PAM10.|Regression, Logistic|||H0: There is no difference in the proportion of patients with at least one ED visits by day 30; H1: The proportion of patients with at least one ED visit for the standard discharge group is greater than that for the enhanced discharge group for day 30.|For day 30, 98 (58 baseline and 40 intervention) patients were used in this analysis.|||0.462
72344946|NCT02684188|144212982|SUPERIORITY|||||||0.394||||||P-values comparing the counts for the 2 groups after adjusting for PAM10.|Regression, Logistic|||H0: There is no difference in the proportion of patients with at least one ED visits by day 60; H1: The proportion of patients with at least one ED visit for the standard discharge group is greater than that for the enhanced discharge group for day 60.|For day 60, 90 (55 baseline and 35 intervention) patients were used in this analysis.|||0.394
72344947|NCT02684188|144212982|SUPERIORITY|||||||0.368||||||Comments (covariates): P-values comparing the counts for the 2 groups after adjusting for PAM10.|Regression, Logistic|||H0: There is no difference in the proportion of patients with at least one ED visits by day 90; H1: The proportion of patients with at least one ED visit for the standard discharge group is greater than that for the enhanced discharge group for day 90.|For day 90, 86 (51 baseline and 35 intervention) patients were used in this analysis.|||0.368
72344948|NCT02684188|144212983|SUPERIORITY|||||||0.946||||||P-values comparing the counts for the 2 groups after adjusting for sex, age, number in household, county, and LACE+ score.|Poisson regression|||The following hypotheses were tested: H0: There is no difference in the cumulative number of PCP visits for day 3 (null hypothesis); H1: The cumulative number of PCP visits for the standard discharge group is less than that for the enhanced discharge group for day 3.|For day 3, 114 (70 baseline and 44 intervention) patients were used in this analysis.|||0.946
72344949|NCT02684188|144212983|SUPERIORITY|||||||0.613|||||||Poisson regression|||H0: There is no difference in the cumulative number of PCP visits for day 7 (null hypothesis); H1: The cumulative number of PCP visits for the standard discharge group is less than that for the enhanced discharge group for day 7.|For day 7, 111 (67 baseline and 44 intervention) patients were used in this analysis.|||0.613
72344950|NCT02684188|144212983|SUPERIORITY|||||||0.541||||||P-values comparing the counts for the 2 groups after adjusting for sex, age, number in household, county, and LACE+ score.|Poisson regression|||H0: There is no difference in the cumulative number of PCP visits for day 14 (null hypothesis); H1: The cumulative number of PCP visits for the standard discharge group is less than that for the enhanced discharge group for day 14.|For day 14, 105 (62 baseline and 43 intervention) patients were used in this analysis.|||0.541
72344951|NCT02684188|144212983|SUPERIORITY|||||||0.765||||||P-values comparing the counts for the 2 groups after adjusting for sex, age, number in household, county, and LACE score.|Poisson regression|||H0: There is no difference in the cumulative number of PCP visits for day 21 (null hypothesis); H1: The cumulative number of PCP visits for the standard discharge group is less than that for the enhanced discharge group for day 21.|For day 21, 98 (58 baseline and 40 intervention) patients were used in this analysis.|||0.765
72344952|NCT02684188|144212983|SUPERIORITY|||||||0.919||||||P-values comparing the counts for the 2 groups after adjusting for sex, age, number in household, county, and LACE+ score.|Poisson regression|||H0: There is no difference in the cumulative number of PCP visits for day 30 (null hypothesis); H1: The cumulative number of PCP visits for the standard discharge group is less than that for the enhanced discharge group for day 30.|For day 30, 95 (57 baseline and 38 intervention) patients were used in this analysis.|||0.919
72344953|NCT02684188|144212983|SUPERIORITY|||||||0.999||||||P-values comparing the counts for the 2 groups after adjusting for sex, age, number in household, county, and LACE score.|Poisson regression|P-values comparing the counts for the 2 groups after adjusting for sex, age, number in household, county, and LACE score.||H0: There is no difference in the cumulative number of PCP visits for day 60 (null hypothesis); H1: The cumulative number of PCP visits for the standard discharge group is less than that for the enhanced discharge group for day 60.|For day 60, 87 (54 baseline and 33 intervention) patients were used in this analysis.|||0.999
72344954|NCT02684188|144212983|SUPERIORITY|||||||0.995|||||||Poisson regression|||H0: There is no difference in the cumulative number of PCP visits for day 90 (null hypothesis); H1: The cumulative number of PCP visits for the standard discharge group is less than that for the enhanced discharge group for day 90.|For day 90, 83 (50 baseline and 33 intervention) patients were used in this analysis.|||0.995
72428776|NCT02204293|144368640|SUPERIORITY|Fisher's exact test with a two-tailed level of significance of α = 0.05.|Difference in Response Rates|19.9||||0.3175|TWO_SIDED|95.0|-15.0|51.3|||Fisher Exact|||||51.3|-15.0|0.3175
72344955|NCT02684188|144212984|EQUIVALENCE|A repeated measures ANOVA model was used to model the SF12 Physical Health score as a function of treatment group. The likelihood ratio test was used to calculate the p-values for the treatment effect and covariates. No adjustments for multiple comparisons were made. Hypotheses were tested after adjusting for the effects of the repeated measures, patient age, and the number of people in a household. All hypotheses were 2-sided and p-values \< 0.05 were considered statistically significant.||||||0.371||||||The P-value comparing the means for the 2 groups averaged across the 7 days is p = 0.371, after adjusting for covariates.|ANOVA|||The following hypotheses were tested: Hoi: There is no difference in mean SF12 Physical Health scores between the standard and enhanced discharge groups (null hypothesis); H1i: The mean SF12 Physical Health scores differ between the standard and enhanced discharge groups.||||0.371
72428777|NCT02204293|144368641|SUPERIORITY|Fisher's exact test with a two-tailed level of significance of α = 0.05.|Difference in Response Rates|31.7||||0.0922|TWO_SIDED|95.0|-2.9|61.8|||Fisher Exact|||||61.8|-2.9|0.0922
72428778|NCT02204293|144368642|SUPERIORITY|Fisher's exact test with a two-tailed level of significance of α = 0.05.|Difference in Response Rates|32.0||||0.0858|TWO_SIDED|95.0|-1.5|61.1|||Fisher Exact|||||61.1|-1.5|0.0858
72428779|NCT02204293|144368643|SUPERIORITY|Fisher's exact test with a two-tailed level of significance of α = 0.05.|Difference in Response Rates|32.4||||0.075|TWO_SIDED|95.0|-0.7|60.5|||Fisher Exact|||||60.5|-0.7|0.075
72344956|NCT02684188|144212985|EQUIVALENCE|A repeated measures ANOVA model was used to model the SF-12 Mental Health score as a function of treatment group. The likelihood ratio test was used to calculate the p-values for the treatment effect and covariates. No adjustments for multiple comparisons were made. Hypotheses were tested after adjusting for the effects of the repeated measures, patient age, income, and county. All hypotheses were 2-sided and p-values \< 0.05 were considered statistically significant.||||||0.232||||||The P-value comparing the means for the 2 groups averaged across the 7 days is p = 0.232, after adjusting for covariates.|ANOVA|||The following hypotheses were tested: Hoi: There is no difference in mean SF-12 Mental Health scores between the standard and enhanced discharge groups (null hypothesis); H1i: The mean SF-12 Mental Health scores differ between the standard and enhanced discharge groups.||||0.232
72344957|NCT02684188|144212986|SUPERIORITY|||||||0.806|||||||ANCOVA|||The following hypotheses were tested: H0: There is no difference in the mean CTM3 score between the standard and enhanced discharge groups (null hypothesis); H1: Patients in the enhanced discharge group will have a higher mean CTM3 rating than patients in the standard discharge group.|An analysis of covariance was used to model the CTM3 discharge planning score as a function of treatment group. An ANOVA F-test was used to calculate the p-values for the treatment effect and covariates. No adjustments for multiple comparisons were made. Hypotheses were tested after adjusting for the effects of patient age and income. The hypothesis test for the group comparison was 1-sided, hypotheses to assess significance of covariates were 2-sided, and p-values \< 0.05 were considered statistically significant. The covariates Sex, County, Number in Household, LACE+ score, and PAM10 score did not differ in their mean CTM3 scores so were not retained in the model.|||0.806
72344958|NCT02684188|144212987|SUPERIORITY|||||||0.742|||||||ANOVA|||The following hypotheses were tested: H0: There is no difference in the mean RTM14 score between the standard and enhanced discharge groups (null hypothesis); H1: Patients in the enhanced discharge group will have a higher mean RTM14 rating than patients in the standard discharge group.|A repeated measures ANOVA model (over the 6 time measurement periods) was used to model the RTM14 score as a function of treatment group. The likelihood ratio test was used to calculate the p-values for the treatment effect and covariates. No adjustments for multiple comparisons were made. Hypotheses were tested after adjusting for the effects of the repeated measures, patient age, income, and whether or not a patient had visited a hospital or ED prior to that day. The hypothesis test for the group comparison was 1-sided, hypotheses to assess significance of covariates were 2-sided, and p-values \< 0.05 were considered statistically significant. The covariates Sex, Number in household, LACE+ score, and PAM10 score were not significant in explaining SF-12 scores so were not retained in the model.|||0.742
72344959|NCT02684188|144212988|SUPERIORITY|||||||0.717||||||This Hypothesis was tested with no adjustments for covariates since none were significant.|Regression, Logistic|||: H0: There is no difference in the cumulative number of PCP visits for day 3 (null hypothesis); H1: The cumulative number of PCP visits for the standard discharge group is less than that for the enhanced discharge group for day 3.|For day 3, 114 (70 baseline and 44 intervention) patients were used in this analysis.|||0.717
72344960|NCT02684188|144212988|SUPERIORITY|||||||0.479||||||This Hypothesis was tested with no adjustments for covariates since none were significant.|Regression, Logistic|||H0: There is no difference in the cumulative number of PCP visits for day 7 (null hypothesis); H1: The cumulative number of PCP visits for the standard discharge group is less than that for the enhanced discharge group for day 7.|For day 7, 111 (67 baseline and 44 intervention) patients were used in this analysis.|||0.479
72344961|NCT02684188|144212988|SUPERIORITY|||||||0.329|||||||Regression, Logistic|||H0: There is no difference in the cumulative number of PCP visits for day 14 (null hypothesis); H1: The cumulative number of PCP visits for the standard discharge group is less than that for the enhanced discharge group for day 14.|For day 14, 105 (62 baseline and 43 intervention) patients were used in this analysis.|||0.329
72344962|NCT02684188|144212988|SUPERIORITY|||||||0.78|||||||Regression, Logistic|||H0: There is no difference in the cumulative number of PCP visits for day 21 (null hypothesis); H1: The cumulative number of PCP visits for the standard discharge group is less than that for the enhanced discharge group for day 21.|This Hypothesis was tested with no adjustments for covariates since none were significant.|||0.780
72344963|NCT02684188|144212988|SUPERIORITY|||||||0.779||||||This Hypothesis was tested with no adjustments for covariates since none were significant.|Regression, Logistic|||H0: There is no difference in the cumulative number of PCP visits for day 30 (null hypothesis); H1: The cumulative number of PCP visits for the standard discharge group is less than that for the enhanced discharge group for day 30.|For day 30, 95 (57 baseline and 38 intervention) patients were used in this analysis.|||0.779
72344964|NCT02684188|144212988|SUPERIORITY|||||||0.848||||||This Hypothesis was tested with no adjustments for covariates since none were significant.|Regression, Logistic|||H0: There is no difference in the cumulative number of PCP visits for day 60 (null hypothesis); H1: The cumulative number of PCP visits for the standard discharge group is less than that for the enhanced discharge group for day 60.|For day 60, 87 (54 baseline and 33 intervention) patients were used in this analysis.|||0.848
72344965|NCT02684188|144212988|SUPERIORITY|||||||0.857||||||This Hypothesis was tested with no adjustments for covariates since none were significant.|Regression, Logistic|||H0: There is no difference in the cumulative number of PCP visits for day 90 (null hypothesis); H1: The cumulative number of PCP visits for the standard discharge group is less than that for the enhanced discharge group for day 90.|For day 90, 83 (50 baseline and 33 intervention) patients were used in this analysis.|||0.857
72344966|NCT00488826|144212995|SUPERIORITY_OR_OTHER||Geometric mean ratio|1097.0||||||90.0|793.6|1461.0||P-Values were not calculated.|||This analysis is for Serotype 4.|"The ratio of the 7vPnC Separately group to the DTaP Alone group geometric mean comparisons (GMC) was provided with a corresponding 90% confidence interval."||1461|793.6|
72344967|NCT00488826|144212995|SUPERIORITY_OR_OTHER||Geometric mean ratio|54.6||||||90.0|35.36|85.49||P-Values were not calculated.|||This analysis is for Serotype 6B.|"The ratio of the 7vPnC Separately group to the DTaP Alone group geometric mean comparisons (GMC) was provided with a corresponding 90% confidence interval."||85.49|35.36|
72428780|NCT02204293|144368644|SUPERIORITY|Fisher's exact test with a two-tailed level of significance of α = 0.05.|Difference in Response Rates|16.0||||0.4018|TWO_SIDED|95.0|-12.6|43.4|||Fisher Exact|||||43.4|-12.6|0.4018
72428781|NCT02204293|144368645|SUPERIORITY|Fisher's exact test with a two-tailed level of significance of α = 0.05.|Difference in Response Rates|5.2||||1|TWO_SIDED|95.0|-18.8|29.2|||Fisher Exact|||||29.2|-18.8|1
72344968|NCT00488826|144212995|SUPERIORITY_OR_OTHER||Geometric mean ratio|99.48||||||90.0|79.81|142.0||P-Values were not calculated.|||This analysis is for Serotype 9V|"The ratio of the 7vPnC Separately group to the DTaP Alone group geometric mean comparisons (GMC) was provided with a corresponding 90% confidence interval."||142.0|79.81|
72344969|NCT00488826|144212995|SUPERIORITY_OR_OTHER||Geometric mean ratio|134.3||||||90.0|80.83|197.1||P-Values were not calculated.|||This analysis is for Serotype 14.|"The ratio of the 7vPnC Separately group to the DTaP Alone group geometric mean comparisons (GMC) was provided with a corresponding 90% confidence interval."||197.1|80.83|
72344970|NCT00488826|144212995|SUPERIORITY_OR_OTHER||Geometric mean ratio|200.3||||||90.0|151.9|302.4||P-Values were not calculated.|||This analysis is for Serotype 18C.|"The ratio of the 7vPnC Separately group to the DTaP Alone group geometric mean comparisons (GMC) was provided with a corresponding 90% confidence interval."||302.4|151.9|
72344971|NCT00488826|144212995|SUPERIORITY_OR_OTHER||Geometric mean ratio|181.3||||||90.0|119.8|253.1||P-Values were not calculated.|||This analysis is for Serotype 19F.|"The ratio of the 7vPnC Separately group to the DTaP Alone group geometric mean comparisons (GMC) was provided with a corresponding 90% confidence interval."||253.1|119.8|
72344972|NCT00488826|144212995|SUPERIORITY_OR_OTHER||Geometric mean ratio|90.02||||||90.0|57.93|150.5||P-Values were not calculated.|||This analysis is for Serotype 23F.|"The ratio of the 7vPnC Separately group to the DTaP Alone group geometric mean comparisons (GMC) was provided with a corresponding 90% confidence interval."||150.5|57.93|
72344973|NCT00488826|144212996|SUPERIORITY_OR_OTHER||Geometric mean ratio|665.1||||||90.0|473.3|851.2||P-Values were not calculated.|||This analysis is for Serotype 4.|"The ratio of the 7vPnC + DTaP Concurrently group to DTaP Alone group geometric mean comparisons (GMC) was provided with a corresponding 90% confidence interval."||851.2|473.3|
72344974|NCT00488826|144212996|SUPERIORITY_OR_OTHER||Geometric mean ratio|22.2||||||90.0|13.99|31.77||P-Values were not calculated.|||This analysis is for Serotype 6B.|"The ratio of the 7vPnC + DTaP Concurrently group to DTaP Alone group geometric mean comparisons (GMC) was provided with a corresponding 90% confidence interval."||31.77|13.99|
72344975|NCT00488826|144212996|SUPERIORITY_OR_OTHER||Geometric mean ratio|73.7||||||90.0|56.41|103.6||P-Values were not calculated.|||This analysis is for Serotype 9V.|"The ratio of the 7vPnC + DTaP Concurrently group to DTaP Alone group geometric mean comparisons (GMC) was provided with a corresponding 90% confidence interval."||103.6|56.41|
72344976|NCT00488826|144212996|SUPERIORITY_OR_OTHER||Geometric mean ratio|99.48||||||90.0|61.09|147.5||P-Values were not calculated.|||This analysis is for Serotype 14.|"The ratio of the 7vPnC + DTaP Concurrently group to DTaP Alone group geometric mean comparisons (GMC) was provided with a corresponding 90% confidence interval."||147.5|61.09|
72344977|NCT00488826|144212996|SUPERIORITY_OR_OTHER||Geometric mean ratio|164.0||||||90.0|114.9|232.9||P-Values were not calculated.|||This analysis is for Serotype 18C.|"The ratio of the 7vPnC + DTaP Concurrently group to DTaP Alone group geometric mean comparisons (GMC) was provided with a corresponding 90% confidence interval."||232.9|114.9|
72428782|NCT02204293|144368646|SUPERIORITY|Fisher's exact test with a two-tailed level of significance of α = 0.05.|Difference in Response Rates|24.8||||0.1642|TWO_SIDED|95.0|-8.0|54.2|||Fisher Exact|||EULAR DAS28-ESR Response||54.2|-8.0|0.1642
72428783|NCT02204293|144368646|SUPERIORITY|Fisher's exact test with a two-tailed level of significance of α = 0.05.|Difference in Response Rates|25.2||||0.1756|TWO_SIDED|95.0|-9.1|55.1|||Fisher Exact|||EULAR DAS28-CRP Response||55.1|-9.1|0.1756
72428784|NCT02204293|144368647|SUPERIORITY|Fisher's exact test with a two-tailed level of significance of α = 0.05.|Difference in Response Rates|3.9||||1|TWO_SIDED|95.0|-27.7|35.0|||Fisher Exact|||DAS28 (ESR) LDA||35.0|-27.7|1
72428785|NCT02204293|144368647|SUPERIORITY|Fisher's exact test with a two-tailed level of significance of α = 0.05.|Difference in Response Rates|26.5||||0.1642|TWO_SIDED|95.0|-6.6|56.0|||Fisher Exact|||DAS28 (CRP) LDA||56.0|-6.6|0.1642
72428786|NCT02204293|144368648|SUPERIORITY|Fisher's exact test with a two-tailed level of significance of α = 0.05.|Difference in Response Rates|21.6||||0.2285|TWO_SIDED|95.0|-8.1|49.9|||Fisher Exact|||DAS28 (ESR) remission||49.9|-8.1|0.2285
72428787|NCT02204293|144368648|SUPERIORITY|Fisher's exact test with a two-tailed level of significance of α = 0.05.|Difference in Response Rates|27.1||||0.1212|TWO_SIDED|95.0|-4.6|54.6|||Fisher Exact|||DAS28 (CRP) Remission||54.6|-4.6|0.1212
72344978|NCT00488826|144212996|SUPERIORITY_OR_OTHER||Geometric mean ratio|81.45||||||90.0|57.98|119.1||P-Values were not calculated.|||This analysis is for Serotype 19F.|"The ratio of the 7vPnC + DTaP Concurrently group to DTaP Alone group geometric mean comparisons (GMC) was provided with a corresponding 90% confidence interval."||119.1|57.98|
72344979|NCT00488826|144212996|SUPERIORITY_OR_OTHER||Geometric mean ratio|44.7||||||90.0|29.48|68.71||P-Values were not calculated.|||This analysis is for Serotype 23F.|"The ratio of the 7vPnC + DTaP Concurrently group to DTaP Alone group geometric mean comparisons (GMC) was provided with a corresponding 90% confidence interval."||68.71|29.48|
72344980|NCT01854281|144213076|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||Fisher Exact|||null hypothesis: there is no difference in the occurence of arterial bubbles after simulated dive between closure and PFO groups.||||0.02
72344981|NCT01854281|144213076|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED|95.0|||||Fisher Exact|||null hypothesis: there is no difference in the occurence of arterial bubbles after simulated dive between closure and PFO groups.||||<0.01
72344982|NCT03208088|144213077|NON_INFERIORITY|The non-inferiority of the Test lens relative to the Control will be concluded if the lower confidence limit of LSM difference is above the non-inferiority margin -5.|Least Square Mean Difference|5.9|STANDARD_ERROR_OF_MEAN|2.92|||TWO_SIDED|95.0|0.1|11.6|||Mixed Models Analysis|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.|LS Mean difference was calculated as Test 1 - Control.|||11.6|0.1|
72344983|NCT03208088|144213077|NON_INFERIORITY|The non-inferiority of the Test lens relative to the Control will be concluded if the lower confidence limit of LSM difference is above the non-inferiority margin -5.|Least Square Mean Difference|2.1|STANDARD_ERROR_OF_MEAN|3.06|||TWO_SIDED|95.0|-4.0|8.1|||Mixed Models Analysis|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.|LS Mean difference was calculated as Test 2 - Control.|||8.1|-4.0|
72428788|NCT02204293|144368648|SUPERIORITY|Fisher's exact test with a two-tailed level of significance of α = 0.05.|Difference in Response Rates|16.0||||0.4018|TWO_SIDED|95.0|-12.6|43.4|||Fisher Exact|||Extended Remission||43.4|-12.6|0.4018
72428789|NCT04285229|144368703|SUPERIORITY||Odds Ratio (OR)|7.64|||<|0.001|TWO_SIDED|95.0|2.68|21.76|||Regression, Logistic|||||21.76|2.68|<0.001
72344984|NCT03208088|144213078|NON_INFERIORITY|The non-inferiority of the Test lens relative to the Control will be concluded if the lower confidence limit of LSM difference is above the non-inferiority margin -5.|Least Square Mean difference|-1.5|STANDARD_ERROR_OF_MEAN|3.06|||TWO_SIDED|95.0|-7.5|4.6|||Mixed Models Analysis|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.|LS Mean difference was calculated as Test 3 - Control.|||4.6|-7.5|
72344985|NCT03208088|144213078|NON_INFERIORITY|The non-inferiority of the Test lens relative to the Control will be concluded if the lower confidence limit of LSM difference is above the non-inferiority margin -5.|Least Square Mean|-3.4|STANDARD_ERROR_OF_MEAN|2.88|||TWO_SIDED|95.0|-9.0|2.3|||Mixed Models Analysis|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.|LS Mean difference was calculated as Test 4 - Control.|||2.3|-9.0|
72344986|NCT00238238|144213083|SUPERIORITY_OR_OTHER|||||||0.29|||||||Fisher Exact|||||||0.29
72344987|NCT00238238|144213084|SUPERIORITY_OR_OTHER|||||||0.002|||||||Log Rank|||||||0.002
72344988|NCT01345669|144213085|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.126||||0.4806|TWO_SIDED|95.0|0.809|1.569|||Log Rank||Hazard ratio (Afatinib vs. Placebo) from Cox proportional hazards model stratified by baseline ECOG (0 or 1) and nodal status (N0-N2a or N2b-N3).|DFS was analysed using a stratified log-rank test with nodal status (N0- N2a vs. N2b-N3) and Eastern Cooperative Oncology Group (ECOG) performance status (0 vs. 1) being the stratification factors.||1.569|0.809|0.4806
72344989|NCT01345669|144213086|SUPERIORITY_OR_OTHER||Difference in Kaplan-Meier estimates|-6.27||||0.161|TWO_SIDED|95.0|-15.04|2.5|||Log Rank||Difference in Kaplan-Meier estimates of Afatinib vs. Placebo is provided.|Kaplan-Meier (KM) curves were calculated for each treatment group, separately, and the estimates of DFS probabilities from the curves and 95% Confidence interval (CI) (using the Greenwood standard error estimate) were tabulated||2.50|-15.04|0.1610
72344990|NCT01345669|144213087|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.444||||0.1301|TWO_SIDED|95.0|0.895|2.332||p-value (two-sided) from log-rank test stratified by baseline ECOG (0 or 1) and nodal status (N0-N2a or N2b-N3).|Log Rank|||Hazard ratio from Cox proportional hazards model stratified by baseline ECOG (0 or 1) and nodal status (N0-N2a or N2b-N3).||2.332|0.895|0.1301
72344991|NCT01345669|144213088|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.431||||0.0561|TWO_SIDED|95.0|0.991|2.068|||Regression, Logistic|||Odds ratio and p-value from logistic regression analysis of 'improved vs. not improved' stratified by baseline ECOG (0 or 1) and nodal status (N0-N2a or N2b-N3) for Swallowing (Q5-Q8 from QLQ-HN35).||2.068|0.991|0.0561
72344992|NCT01345669|144213088|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.446||||0.0523|TWO_SIDED|95.0|0.996|2.098|||Regression, Logistic|||Odds ratio and p-value from logistic regression analysis of 'improved vs. not improved' stratified by baseline ECOG (0 or 1) and nodal status (N0-N2a or N2b-N3) for Pain HN35 (Q1-Q4 from QLQ-HN35).||2.098|0.996|0.0523
72344993|NCT01345669|144213088|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.818||||0.257|TWO_SIDED|95.0|0.577|1.158|||Regression, Logistic|||Odds ratio and p-value from logistic regression analysis of 'improved vs. not improved' stratified by baseline ECOG (0 or 1) and nodal status (N0-N2a or N2b-N3) for Global health status/QoL(Q29-Q30 from QLQ-C30).||1.158|0.577|0.2570
72344994|NCT01345669|144213089|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.295||||0.0591|TWO_SIDED|95.0|0.986|1.7||P-value from log-rank test stratified by baseline ECOG (0 or 1) and nodal status (N0-N2a or N2b-N3).|Log Rank|||For swallowing scale; Hazard ratio from Cox proportional hazard model stratified by baseline ECOG (0 or 1) and nodal status (N0-N2a or N2b-N3).||1.700|0.986|0.0591
72344995|NCT01345669|144213089|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.456||||0.0049|TWO_SIDED|95.0|1.113|1.905||P-value from log-rank test stratified by baseline ECOG (0 or 1) and nodal status (N0-N2a or N2b-N3).|Log Rank|||For pain HN35 scale; Hazard ratio from Cox proportional hazard model stratified by baseline ECOG (0 or 1) and nodal status (N0-N2a or N2b-N3).||1.905|1.113|0.0049
72428790|NCT04285229|144368704|SUPERIORITY||Odds Ratio (OR)|6.4|||<|0.001|TWO_SIDED|95.0|2.42|16.9|||Regression, Logistic|||||16.90|2.42|<0.001
72344996|NCT01345669|144213089|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.604||||0.0002|TWO_SIDED|95.0|1.238|2.079||P-value from log-rank test stratified by baseline ECOG (0 or 1) and nodal status (N0-N2a or N2b-N3).|Log Rank|||For global health status/QoL scale; Hazard ratio from Cox proportional hazard model stratified by baseline ECOG (0 or 1) and nodal status (N0-N2a or N2b-N3).||2.079|1.238|0.0002
72344997|NCT01345669|144213090|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.3|STANDARD_ERROR_OF_MEAN|1.08||0.2232|TWO_SIDED|95.0|-0.81|3.45|||Mixed Models Analysis|Degrees of freedom calculated using the Kenward-Roger method.|Afatinib minus Placebo mean adjusted for total with data for baseline ECOG (0 or 1) and nodal status (N0-N2a or N2b-N3).|Scores (swallowing scale) over time were assessed using longitudinal mixed-effects growth curve models with the average profile over time for each endpoint described by a piecewise linear model adjusted for the fixed effects baseline ECOG performance score and nodal status.||3.45|-0.81|0.2232
72344998|NCT01345669|144213090|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.2|STANDARD_ERROR_OF_MEAN|1.08||0.0028|TWO_SIDED|95.0|1.12|5.36|||Mixed Models Analysis|Degrees of freedom calculated using the Kenward-Roger method.|Afatinib minus Placebo mean adjusted for total with data for baseline ECOG (0 or 1) and nodal status (N0-N2a or N2b-N3).|Scores (pain scale) over time were assessed using longitudinal mixed-effects growth curve models with the average profile over time for each endpoint described by a piecewise linear model adjusted for the fixed effects baseline ECOG performance score and nodal status.||5.36|1.12|0.0028
72344999|NCT01345669|144213090|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.4|STANDARD_ERROR_OF_MEAN|0.98||0.0005|TWO_SIDED|95.0|-5.33|-1.49|||Mixed Models Analysis|Degrees of freedom calculated using the Kenward-Roger method.|Afatinib minus Placebo mean adjusted for total with data for baseline ECOG (0 or 1) and nodal status (N0-N2a or N2b-N3).|Scores (global health/QoL) over time were assessed using longitudinal mixed-effects growth curve models with the average profile over time for each endpoint described by a piecewise linear model adjusted for the fixed effects baseline ECOG performance score and nodal status.||-1.49|-5.33|0.0005
72345000|NCT01793883|144213091|SUPERIORITY|||||||0.251|||||||Log Rank|||||||0.251
72345001|NCT01793883|144213091|SUPERIORITY|||||||0.818|||||||Log Rank|||||||0.818
72428791|NCT04285229|144368705|SUPERIORITY||Odds Ratio (OR)|2.58||||0.006|TWO_SIDED|95.0|1.31|5.09|||Regression, Logistic|||||5.09|1.31|0.006
72428792|NCT04285229|144368706|SUPERIORITY||LS Mean Difference|-1.14|STANDARD_ERROR_OF_MEAN|0.12|<|0.001|TWO_SIDED|95.0|-1.38|-0.9|||Mixed Models Analysis|||||-0.90|-1.38|<0.001
72345002|NCT02478255|144213092|OTHER|||||||0.22|||||||t-test, 2 sided|||||||0.22
72345003|NCT00516165|144213097|SUPERIORITY_OR_OTHER|||||||0.05|||||||Kaplan Meier|||||||0.05
72345004|NCT00516165|144213098|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Kaplan-Meier|||||||<0.05
72345005|NCT00516165|144213099|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Kaplan-Meier|||||||<0.05
72345006|NCT00516165|144213100|SUPERIORITY_OR_OTHER|||||||0.05|TWO_SIDED||||||Kaplan-Meier|||||||0.05
72345007|NCT00516165|144213101|SUPERIORITY_OR_OTHER|||||||0.05|TWO_SIDED||||||Kaplan-Meier|||||||0.05
72345008|NCT00516165|144213102|SUPERIORITY_OR_OTHER|||||||0.05|TWO_SIDED||||||Kaplan-Meier|||||||0.05
72345009|NCT00061633|144213109|NON_INFERIORITY_OR_EQUIVALENCE|Sample size was selected on the basis of clinical judgment and was deemed adequate to provide clinically meaningful descriptive results consistent with study objectives. This sample size was estimated to provide 39% power to test televancin's non-inferiority to vancomycin with respect to clinical response using a non-inferiority margin of 10%.||||||0.5289|||||||2-sided 95% confidence interval|||95% Confidence Interval: -0.1349 to 0.0485 No est. value. Parameter that was estimated: Risk Difference||||0.5289
72345010|NCT01431963|144213110|SUPERIORITY_OR_OTHER||percentage of participants|43.1|||||TWO_SIDED|95.0|30.85|55.96|||||The estimated value reflects the percentage of participants who were seizure free for all seizures.|||55.96|30.85|
72345011|NCT01431963|144213110|SUPERIORITY_OR_OTHER||percentage of participants|40.0|||||TWO_SIDED|95.0|27.02|54.09|||||The estimated value reflects the percentage of participants who were seizure free for A+B+C seizures.|||54.09|27.02|
72345012|NCT01431963|144213110|SUPERIORITY_OR_OTHER||percentage of participants|40.5|||||TWO_SIDED|95.0|25.63|56.72|||||The estimated value reflects the percentage of participants who were seizure free for A+B seizures.|||56.72|25.63|
72345013|NCT01431963|144213110|SUPERIORITY_OR_OTHER||percentage of participants|69.7|||||TWO_SIDED|95.0|51.29|84.41|||||The estimated value reflects the percentage of participants who were seizure free for C seizures.|||84.41|51.29|
72428793|NCT04285229|144368707|SUPERIORITY||LS Mean Difference|-1.49|STANDARD_ERROR_OF_MEAN|0.28|<|0.001|TWO_SIDED|95.0|-2.04|-0.94|||Mixed Models Analysis|||||-0.94|-2.04|<0.001
72345014|NCT01431963|144213110|SUPERIORITY_OR_OTHER||percentage of participants|80.0|||||TWO_SIDED|95.0|44.39|97.48|||||The estimated value reflects the percentage of participants who were seizure free for D5 seizures.|||97.48|44.39|
72345015|NCT03109184|144213113|SUPERIORITY||Odds Ratio (OR)|1.21|||||TWO_SIDED||||||||3-Month follow-up between groups odds ratio of DV perpetration|||||
72345016|NCT03109184|144213113|SUPERIORITY||Odds Ratio (OR)|0.61|||||TWO_SIDED||||||||9-month follow-up between group odds ratio of DV perpetration|||||
72345017|NCT03109184|144213113|SUPERIORITY||Odds Ratio (OR)|1.79|||||TWO_SIDED||||||||3-month follow-up between groups odds ratio of DV victimization|||||
72345018|NCT03109184|144213113|SUPERIORITY||Odds Ratio (OR)|0.86|||||TWO_SIDED||||||||9-month follow-up between groups odds ratio of DV victimization|||||
72428794|NCT04285229|144368708|SUPERIORITY||LS Mean Difference|-0.87|STANDARD_ERROR_OF_MEAN|0.28||0.002|TWO_SIDED|95.0|-1.43|-0.32|||Mixed Models Analysis|||||-0.32|-1.43|0.002
72345019|NCT03109184|144213114|SUPERIORITY||Effect Size (d)|-0.07|||||TWO_SIDED||||||||3-month follow-up between groups effect size of general aggression|||||
72345020|NCT03109184|144213114|SUPERIORITY||Effect Size (d)|0.01|||||TWO_SIDED||||||||9-month follow-up between groups effect size of general aggression|||||
72345021|NCT03109184|144213115|SUPERIORITY||Effect Size (d)|0.01|||||TWO_SIDED||||||||3-month follow-up between groups effect size of adolescent attitudes support aggression|||||
72345022|NCT03109184|144213115|SUPERIORITY||Effect Size (d)|-0.17|||||TWO_SIDED||||||||9-month follow-up between groups effect size of adolescent attitudes support aggression|||||
72345023|NCT03109184|144213115|SUPERIORITY||Effect Size (d)|0.19|||||TWO_SIDED||||||||3-month follow-up between groups effect size of parent attitudes support aggression|||||
72345024|NCT03109184|144213115|SUPERIORITY||Effect Size (d)|0.2|||||TWO_SIDED||||||||9-month follow-up between groups effect size of parent attitudes support aggression|||||
72345025|NCT03109184|144213116|SUPERIORITY||Effect Size (d)|0.09|||||TWO_SIDED||||||||3-month follow-up between groups effect size of adolescent short-term self-regulation|||||
72345026|NCT03109184|144213116|SUPERIORITY||Effect Size (d)|0.36|||||TWO_SIDED||||||||9-month follow-up between groups effect size of adolescent short-term self-regulation|||||
72345027|NCT03109184|144213116|SUPERIORITY||Effect Size (d)|-0.11|||||TWO_SIDED||||||||3-month follow-up between groups effect size of adolescent long-term self-regulation|||||
72345028|NCT03109184|144213116|SUPERIORITY||Effect Size (d)|0.11|||||TWO_SIDED||||||||9-month follow-up between groups effect size of adolescent long-term self-regulation|||||
72345029|NCT03109184|144213117|SUPERIORITY||Effect Size (d)|0.11|||||TWO_SIDED||||||||3-month follow-up between groups effect size of adolescent reported open family communication|||||
72345030|NCT03109184|144213117|SUPERIORITY||Effect Size (d)|0.06|||||TWO_SIDED||||||||9-month follow-up between groups effect size of adolescent reported open family communication|||||
72345031|NCT03109184|144213117|SUPERIORITY||Effect Size (d)|-0.15|||||TWO_SIDED||||||||3-month follow-up between groups effect size of adolescent reported problems in family communication|||||
72345032|NCT03109184|144213117|SUPERIORITY||Effect Size (d)|0.06|||||TWO_SIDED||||||||9-month follow-up between groups effect size of adolescent reported problems in family communication|||||
72345033|NCT03109184|144213117|SUPERIORITY||Effect Size (d)|0.62|||||TWO_SIDED||||||||3-month follow-up between groups effect size of adolescent reported number of relationship topics discussed|||||
72345034|NCT03109184|144213117|SUPERIORITY||Effect Size (d)|0.13|||||TWO_SIDED||||||||9-month follow-up between groups effect size of adolescent reported number of relationship topics discussed|||||
72345035|NCT03109184|144213117|SUPERIORITY||Effect Size (d)|0.15|||||TWO_SIDED||||||||3-month follow-up between groups effect size of parent reported open family communication|||||
72345036|NCT03109184|144213117|SUPERIORITY||Effect Size (d)|0.01|||||TWO_SIDED||||||||9-month follow-up between groups effect size of parent reported open family communication|||||
72345037|NCT03109184|144213117|SUPERIORITY||Effect Size (d)|-0.15|||||TWO_SIDED||||||||3-month follow-up between groups effect size of parent reported problems in family communication|||||
72345038|NCT03109184|144213117|SUPERIORITY||Effect Size (d)|0.25|||||TWO_SIDED||||||||9-month follow-up between groups effect size of parent reported problems in family communication|||||
72345039|NCT03109184|144213117|SUPERIORITY||Effect Size (d)|0.66|||||TWO_SIDED||||||||3-month follow-up between groups effect size of parent reported number of relationship topics discussed|||||
72428795|NCT04285229|144368709|SUPERIORITY||LS Mean Difference|-7.72|STANDARD_ERROR_OF_MEAN|1.58|<|0.001|TWO_SIDED|95.0|-10.85|-4.6|||ANCOVA|||||-4.60|-10.85|<0.001
72345040|NCT03109184|144213117|SUPERIORITY||Effect Size (d)|-0.1|||||TWO_SIDED||||||||9-month follow-up between groups effect size of parent reported number of relationship topics discussed|||||
72345041|NCT03109184|144213118|SUPERIORITY||Effect Size (d)|0.15|||||TWO_SIDED||||||||3-month follow-up between groups effect size of adolescent emotion-regulation|||||
72345042|NCT03109184|144213118|SUPERIORITY||Effect Size (d)|0.32|||||TWO_SIDED||||||||9-month follow-up between groups effect size of adolescent emotion-regulation|||||
72345043|NCT03109184|144213119|SUPERIORITY||Effect Size (d)|-0.11|||||TWO_SIDED||||||||3-month follow-up between groups effect size of adolescent distress tolerance|||||
72345044|NCT03109184|144213119|SUPERIORITY||Effect Size (d)|0.23|||||TWO_SIDED||||||||9-month follow-up between groups effect size of adolescent distress tolerance|||||
72345045|NCT00602420|144213120|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.67||||0.037|TWO_SIDED|95.0|0.1|3.24|||t-test, 2 sided|||Tested at the two-sided 0.05 significance level.||3.24|0.10|0.037
72345046|NCT00602420|144213120|SUPERIORITY_OR_OTHER|||||||0.007|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Tested at the two-sided 0.05 significance level.||||0.007
72345047|NCT03592368|144213233|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
72345048|NCT03592368|144213235|SUPERIORITY|||||||0.32|||||||Wilcoxon (Mann-Whitney)|||||||0.32
72345049|NCT03592368|144213236|SUPERIORITY|||||||0.12|||||||t-test, 1 sided|||||||0.12
72345050|NCT01107665|144213247|OTHER||Log Rank HR|0.784||||0.49|TWO_SIDED|95.0|0.41|1.54|||Log Rank|||||1.54|.41|0.49
72345051|NCT02008227|144213250|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.73||||0.0003|TWO_SIDED|95.0|0.62|0.87|||Log Rank|||Stratified analysis based on the strata of IC levels per interactive voice/web response system (IxRS), the number of prior chemotherapy regimens per IxRS, and histology per electronic case report form (eCRF).||0.87|0.62|0.0003
72345052|NCT02008227|144213250|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.73||||0.0002|TWO_SIDED|95.0|0.62|0.86|||Log Rank|||Unstratified Analysis||0.86|0.62|0.0002
72345053|NCT02008227|144213251|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.74||||0.0102|TWO_SIDED|95.0|0.58|0.93|||Log Rank|||Stratified analysis based on the strata of IC levels per IxRS, the number of prior chemotherapy regimens per IxRS, and histology per eCRF.||0.93|0.58|0.0102
72345054|NCT02008227|144213251|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.72||||0.0052|TWO_SIDED|95.0|0.58|0.91|||Log Rank|||Unstratified Analysis||0.91|0.58|0.0052
72345055|NCT02008227|144213254|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.95||||0.4928|TWO_SIDED|95.0|0.82|1.1|||Log Rank|||Stratified analysis based on the strata of IC levels per IxRS, the number of prior chemotherapy regimens per IxRS, and histology per eCRF.||1.10|0.82|0.4928
72345056|NCT02008227|144213254|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.93||||0.3596|TWO_SIDED|95.0|0.81|1.08|||Log Rank|||Unstratified Analysis||1.08|0.81|0.3596
72345057|NCT02008227|144213255|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.91||||0.3806|TWO_SIDED|95.0|0.74|1.12|||Log Rank|||Stratified analysis based on the strata of IC levels per IxRS, the number of prior chemotherapy regimens per IxRS, and histology per eCRF.||1.12|0.74|0.3806
72345058|NCT02008227|144213255|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.91||||0.3249|TWO_SIDED|95.0|0.74|1.1|||Log Rank|||Unstratified Analysis||1.10|0.74|0.3249
72345059|NCT02008227|144213258|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.31|||<|0.0001|TWO_SIDED|95.0|0.18|0.55|||Log Rank|||Stratified analysis based on the strata of IC levels per IxRS, the number of prior chemotherapy regimens per IxRS, and histology per eCRF.||0.55|0.18|<0.0001
72345060|NCT02008227|144213258|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.34|||<|0.0001|TWO_SIDED|95.0|0.21|0.55|||Log Rank|||Unstratified Analysis||0.55|0.21|<0.0001
72345061|NCT02008227|144213259|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.31||||0.0006|TWO_SIDED|95.0|0.15|0.62|||Log Rank|||Stratified analysis based on the strata of IC levels per IxRS, the number of prior chemotherapy regimens per IxRS, and histology per eCRF.||0.62|0.15|0.0006
72345062|NCT02008227|144213259|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.38||||0.0003|TWO_SIDED|95.0|0.22|0.65|||Log Rank|||Unstratified Analysis||0.65|0.22|0.0003
72345063|NCT02008227|144213263|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.72||||0.0111|TWO_SIDED|95.0|0.55|0.93|||Log Rank|||Pain in Chest: Stratified analysis based on the strata of IC levels per IxRS, the number of prior chemotherapy regimens per IxRS, and histology per eCRF.||0.93|0.55|0.0111
72345064|NCT02008227|144213263|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.06||||0.6305|TWO_SIDED|95.0|0.84|1.33|||Log Rank|||Cough: Unstratified Analysis||1.33|0.84|0.6305
72345065|NCT02008227|144213263|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.97||||0.7406|TWO_SIDED|95.0|0.81|1.16|||Log Rank|||Dyspnea: Unstratified Analysis||1.16|0.81|0.7406
72345066|NCT02008227|144213263|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.92||||0.5221|TWO_SIDED|95.0|0.73|1.17|||Log Rank|||Arm/Shoulder Pain||1.17|0.73|0.5221
72345067|NCT02008227|144213278|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.8||||0.0012|TWO_SIDED|95.0|0.7|0.92|||Log Rank|||Stratified analysis based on the strata of IC levels per interactive voice/web response system (IxRS), the number of prior chemotherapy regimens per IxRS, and histology per electronic case report form (eCRF).||0.92|0.70|0.0012
72345068|NCT02008227|144213279|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.77||||0.0045|TWO_SIDED|95.0|0.64|0.92|||Log Rank|||Stratified analysis based on the strata of IC levels per interactive voice/web response system (IxRS), the number of prior chemotherapy regimens per IxRS, and histology per electronic case report form (eCRF).||0.92|0.64|0.0045
72345069|NCT02008227|144213280|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.64||||0.0012|TWO_SIDED|95.0|0.49|0.84|||Log Rank|||Stratified analysis based on the strata of IC levels per interactive voice/web response system (IxRS), the number of prior chemotherapy regimens per IxRS, and histology per electronic case report form (eCRF).||0.84|0.49|0.0012
72345070|NCT02008227|144213281|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.45|||<|0.0001|TWO_SIDED|95.0|0.3|0.68|||Log Rank|||Stratified analysis based on the strata of IC levels per interactive voice/web response system (IxRS), the number of prior chemotherapy regimens per IxRS, and histology per electronic case report form (eCRF).||0.68|0.30|<0.0001
72345071|NCT02008227|144213282|SUPERIORITY_OR_OTHER_LEGACY||Stratified Hazard Ratio|0.96||||0.4981|TWO_SIDED|95.0|0.85|1.08|||Log Rank|||||1.08|0.85|0.4981
72345072|NCT02008227|144213284|SUPERIORITY_OR_OTHER_LEGACY||Unstratified Hazard Ratio|0.32|||||TWO_SIDED|95.0|0.21|0.48||||||||0.48|0.21|
72345073|NCT03354273|144213296|OTHER|Sensitivity was compared to a pre-specified threshold of 60%.|||||<|0.0001|||||||One-sided z-tests|The hypothesis tests were one-sided z-tests with a significance level of 0.025.||Reader 1: Sensitivity||||<0.0001
72428796|NCT04285229|144368710|SUPERIORITY||LS Mean Difference|2.62|STANDARD_ERROR_OF_MEAN|0.785||0.001|TWO_SIDED|95.0|1.07|4.17|||Mixed Models Analysis|||||4.17|1.07|0.001
72345074|NCT03354273|144213296|OTHER|Specificity was compared to a pre-specified threshold of 60%.||||||0.0182|||||||One-sided z-tests|The hypothesis tests were one-sided z-tests with a significance level of 0.025.||Reader 1: Specificity||||0.0182
72345075|NCT03354273|144213296|OTHER|Sensitivity was compared to a pre-specified threshold of 60%.|||||<|0.0001|||||||One-sided z-tests|The hypothesis tests were one-sided z-tests with a significance level of 0.025.||Reader 2: Sensitivity||||<0.0001
72345076|NCT03354273|144213296|OTHER|Specificity was compared to a pre-specified threshold of 60%.||||||0.0002|||||||One-sided z-tests|The hypothesis tests were one-sided z-tests with a significance level of 0.025.||Reader 2: Specificity||||0.0002
72345077|NCT03354273|144213296|OTHER|Sensitivity was compared to a pre-specified threshold of 60%.|||||<|0.0001|||||||One-sided z-tests|The hypothesis tests were one-sided z-tests with a significance level of 0.025.||Reader 3: Sensitivity||||<0.0001
72345078|NCT03354273|144213296|OTHER|Specificity was compared to a pre-specified threshold of 60%.||||||0.997|||||||One-sided z-tests|The hypothesis tests were one-sided z-tests with a significance level of 0.025.||Reader 3: Specificity||||0.9970
72345079|NCT03354273|144213296|OTHER|Sensitivity was compared to a pre-specified threshold of 60%.|||||<|0.0001|||||||One-sided z-tests|The hypothesis tests were one-sided z-tests with a significance level of 0.025.||Majority Rule: Sensitivity||||<0.0001
72345080|NCT03354273|144213296|OTHER|Specificity was compared to a pre-specified threshold of 60%.||||||0.0781|||||||One-sided z-tests|The hypothesis tests were one-sided z-tests with a significance level of 0.025.||Majority Rule: Specificity||||0.0781
72345081|NCT03354273|144213297|SUPERIORITY|The test of sensitivity comparison between Flurpiridaz (18F) Injection PET MPI and SPECT MPI was performed with a 1-sided McNemar's test at a significance level of 0.025 using 1-sided McNemar's tests.|Difference between PET MPI and SPECT MPI|14.5|||<|0.0001|TWO_SIDED|95.0|6.5|22.4|||McNemar|The hypothesis tests were 1-sided McNemar's tests with a significance level of 0.025 for sensitivity.||Reader 1: Sensitivity||22.4|6.5|<0.0001
72345082|NCT03354273|144213297|NON_INFERIORITY|The test of specificity noninferiority between Flurpiridaz (18F) Injection PET MPI and SPECT MPI was performed with a paired test for noninferiority at a 1-sided significance level of 0.025 using Nam's RMLE method (margin=0.1).|Difference between PET MPI and SPECT MPI|2.4||||0.0004|TWO_SIDED|95.0|-4.9|9.7|||Nam's RMLE|||Reader 1: Specificity||9.7|-4.9|0.0004
72345083|NCT03354273|144213297|SUPERIORITY|The test of sensitivity comparison between Flurpiridaz (18F) Injection PET MPI and SPECT MPI was performed with a 1-sided McNemar's test at a significance level of 0.025 using 1-sided McNemar's tests.|Difference between PET MPI and SPECT MPI|12.9||||0.0002|TWO_SIDED|95.0|4.7|21.0|||McNemar|||Reader 2: Sensitivity||21.0|4.7|0.0002
72345084|NCT03354273|144213297|NON_INFERIORITY|The test of specificity noninferiority between Flurpiridaz (18F) Injection PET MPI and SPECT MPI was performed with a paired test for noninferiority at a 1-sided significance level of 0.025 using Nam's RMLE method (margin=0.1).|Difference between PET MPI and SPECT MPI|4.9|||<|0.0001|TWO_SIDED|95.0|-2.1|11.8|||Nam's RMLE|||Reader 2: Specificity||11.8|-2.1|<0.0001
72345085|NCT03354273|144213297|SUPERIORITY|The test of sensitivity comparison between Flurpiridaz (18F) Injection PET MPI and SPECT MPI was performed with a 1-sided McNemar's test at a significance level of 0.025 using 1-sided McNemar's tests.|Difference between PET MPI and SPECT MPI|13.3|||<|0.0001|TWO_SIDED|95.0|6.6|19.9|||McNemar|||Reader 3: Sensitivity||19.9|6.6|<0.0001
72345086|NCT03354273|144213297|NON_INFERIORITY|The test of specificity noninferiority between Flurpiridaz (18F) Injection PET MPI and SPECT MPI was performed with a paired test for noninferiority at a 1-sided significance level of 0.025 using Nam's RMLE method (margin=0.1).|Difference between PET MPI and SPECT MPI|1.2||||0.0011|TWO_SIDED|95.0|-6.0|8.4|||Nam's RMLE|||Reader 3: Specificity||8.4|-6.0|0.0011
72345087|NCT03354273|144213297|SUPERIORITY|The test of sensitivity comparison between Flurpiridaz (18F) Injection PET MPI and SPECT MPI was performed with a 1-sided McNemar's test at a significance level of 0.025 using 1-sided McNemar's tests.|Difference between PET MPI and SPECT MPI|11.6||||0.0003|TWO_SIDED|95.0|4.1|19.2|||McNemar|||Majority Rule: Sensitivity||19.2|4.1|0.0003
72428797|NCT04285229|144368711|SUPERIORITY||LS Mean Difference|0.51|STANDARD_ERROR_OF_MEAN|1.152||0.66|TWO_SIDED|95.0|-1.77|2.79|||Mixed Models Analysis|||||2.79|-1.77|0.660
72345088|NCT03354273|144213297|NON_INFERIORITY|The test of specificity noninferiority between Flurpiridaz (18F) Injection PET MPI and SPECT MPI was performed with a paired test for noninferiority at a 1-sided significance level of 0.025 using Nam's RMLE method (margin=0.1).|Difference between PET MPI and SPECT MPI|2.1||||0.0004|TWO_SIDED|95.0|-5.0|9.3|||Nam's RMLE|||Majority Rule: Specificity||9.3|-5.0|0.0004
72345089|NCT03354273|144213298|SUPERIORITY|The test of sensitivity comparison between Flurpiridaz (18F) Injection PET MPI and SPECT MPI was performed with a 1-sided McNemar's test at a significance level of 0.025 using 1-sided McNemar's tests.|Difference between PET MPI and SPECT MPI|24.4||||0.0127|TWO_SIDED|95.0|5.4|43.4|||McNemar|||Reader 1: Sensitivity||43.4|5.4|0.0127
72345090|NCT03354273|144213298|NON_INFERIORITY|The test of specificity noninferiority between Flurpiridaz (18F) Injection PET MPI and SPECT MPI was performed with a paired test for noninferiority at a 1-sided significance level of 0.025 using Nam's RMLE method (margin=0.1).|Difference between PET MPI and SPECT MPI|9.5||||0.0001|TWO_SIDED|95.0|-1.2|20.2|||Nam's RMLE|||Reader 1: Specificity||20.2|-1.2|0.0001
72345091|NCT03354273|144213298|SUPERIORITY|The test of sensitivity comparison between Flurpiridaz (18F) Injection PET MPI and SPECT MPI was performed with a 1-sided McNemar's test at a significance level of 0.025 using 1-sided McNemar's tests.|Difference between PET MPI and SPECT MPI|22.0||||0.0195|TWO_SIDED|95.0|2.2|41.7|||McNemar|||Reader 2: Sensitivity||41.7|2.2|0.0195
72345092|NCT03354273|144213298|NON_INFERIORITY|The test of specificity noninferiority between Flurpiridaz (18F) Injection PET MPI and SPECT MPI was performed with a paired test for noninferiority at a 1-sided significance level of 0.025 using Nam's RMLE method (margin=0.1).|Difference between PET MPI and SPECT MPI|6.8||||0.0004|TWO_SIDED|95.0|-3.2|16.8|||Nam's RMLE|||Reader 2: Specificity||16.8|-3.2|0.0004
72428798|NCT04285229|144368712|SUPERIORITY||LS Mean Difference|-12.75|STANDARD_ERROR_OF_MEAN|1.594|<|0.001|TWO_SIDED|95.0|-15.91|-9.59|||Mixed Models Analysis|||||-9.59|-15.91|<0.001
72428799|NCT04285229|144368713|SUPERIORITY||LS Mean Difference|-0.36|STANDARD_ERROR_OF_MEAN|0.106|<|0.001|TWO_SIDED|95.0|-0.57|-0.15|||Mixed Models Analysis|||||-0.15|-0.57|<0.001
72428800|NCT04285229|144368714|SUPERIORITY||LS Mean Difference|-0.72|STANDARD_ERROR_OF_MEAN|0.413||0.086|TWO_SIDED|95.0|-1.54|0.1|||Mixed Models Analysis|||||0.10|-1.54|0.086
72345093|NCT03354273|144213298|SUPERIORITY|The test of sensitivity comparison between Flurpiridaz (18F) Injection PET MPI and SPECT MPI was performed with a 1-sided McNemar's test at a significance level of 0.025 using 1-sided McNemar's tests.|Difference between PET MPI and SPECT MPI|17.1||||0.0174|TWO_SIDED|95.0|1.7|32.4|||McNemar|||Reader 3: Sensitivity||32.4|1.7|0.0174
72345094|NCT03354273|144213298|NON_INFERIORITY|The test of specificity noninferiority between Flurpiridaz (18F) Injection PET MPI and SPECT MPI was performed with a paired test for noninferiority at a 1-sided significance level of 0.025 using Nam's RMLE method (margin=0.1).|Difference between PET MPI and SPECT MPI|0.7||||0.024|TWO_SIDED|95.0|-9.9|11.3|||Nam's RMLE|||||11.3|-9.9|0.0240
72345095|NCT03354273|144213298|SUPERIORITY||Difference between PET MPI and SPECT MPI|17.1||||0.0448|TWO_SIDED|95.0|-1.5|35.6|||McNemar|||Majority Rule: Sensitivity||35.6|-1.5|0.0448
72345096|NCT03354273|144213298|NON_INFERIORITY|The test of specificity noninferiority between Flurpiridaz (18F) Injection PET MPI and SPECT MPI was performed with a paired test for noninferiority at a 1-sided significance level of 0.025 using Nam's RMLE method (margin=0.1).|Difference between PET MPI and SPECT MPI|6.8||||0.0004|TWO_SIDED|95.0|-3.4|17.0|||Nam's RMLE|||Majority Rule: Specificity||17.0|-3.4|0.0004
72345097|NCT03354273|144213299|SUPERIORITY|The test of sensitivity comparison between Flurpiridaz (18F) Injection PET MPI and SPECT MPI was performed with a 1-sided McNemar's test at a significance level of 0.025 using 1-sided McNemar's tests.|Difference between PET MPI and SPECT MPI|12.0||||0.0116|TWO_SIDED|95.0|0.0|23.9|||McNemar|||Reader 1: Sensitivity||23.9|0.0|0.0116
72428801|NCT04285229|144368715|SUPERIORITY||LS Mean Difference|-5.67|STANDARD_ERROR_OF_MEAN|1.034|<|0.001|TWO_SIDED|95.0|-7.71|-3.62|||ANCOVA|||||-3.62|-7.71|<0.001
72428802|NCT01406717|144368720|OTHER||ANCOVA|0.0002|||||TWO_SIDED|95.0|-0.31377|0.31418||||||||0.31418|-0.31377|
72428803|NCT01406717|144368721|OTHER||ANCOVA|5.898|||||TWO_SIDED|95.0|-6.7565|18.5535||||||||18.5535|-6.7565|
72428804|NCT01406717|144368722|OTHER||||||<|0.0001|||||||Mantel Haenszel|||||||<0.0001
72428805|NCT01406717|144368724|OTHER|||||||0.6318|||||||ANCOVA|||||||0.6318
72428806|NCT01406717|144368725|OTHER|||||||0.4887|||||||ANOVA|||||||0.4887
72428807|NCT01406717|144368726|OTHER|||||||0.3813|||||||ANOVA|||||||0.3813
72428808|NCT01406717|144368727|OTHER|||||||0.99|||||||ANOVA|||||||0.9900
72345098|NCT03354273|144213299|NON_INFERIORITY|The test of specificity noninferiority between Flurpiridaz (18F) Injection PET MPI and SPECT MPI was performed with a paired test for noninferiority at a 1-sided significance level of 0.025 using Nam's RMLE method (margin=0.1).|Difference between PET MPI and SPECT MPI|6.6||||0.0003|TWO_SIDED|95.0|-2.9|16.2|||Nam's RMLE|||Reader 1: Specificity||16.2|-2.9|0.0003
72428809|NCT01406717|144368728|OTHER|||||||0.0017|||||||ANOVA|||||||0.0017
72428810|NCT01406717|144368729|OTHER|||||||0.6098|||||||Mantel Haenszel|||||||0.6098
72428811|NCT01406717|144368730|OTHER|||||||0.7324|||||||ANOVA|||||||0.7324
72428812|NCT01406717|144368731|OTHER|||||||0.2984|||||||ANOVA|||||||0.2984
72428813|NCT03257995|144368732|OTHER||Mean Difference (Final Values)|0.1861|||<|0.001|TWO_SIDED|95.0|0.1293|0.2429|||ANOVA|||||0.2429|0.1293|<0.001
72428814|NCT03257995|144368732|OTHER||Mean Difference (Final Values)|0.1463|||<|0.001|TWO_SIDED|95.0|0.0898|0.2029|||ANOVA|||||0.2029|0.0898|<0.001
72345099|NCT03354273|144213299|SUPERIORITY|The test of sensitivity comparison between Flurpiridaz (18F) Injection PET MPI and SPECT MPI was performed with a 1-sided McNemar's test at a significance level of 0.025 using 1-sided McNemar's tests.|Difference between PET MPI and SPECT MPI|6.8||||0.1085|TWO_SIDED|95.0|-5.2|18.9|||McNemar|||Reader 2: Sensitivity||18.9|-5.2|0.1085
72345100|NCT03354273|144213299|NON_INFERIORITY|The test of specificity noninferiority between Flurpiridaz (18F) Injection PET MPI and SPECT MPI was performed with a paired test for noninferiority at a 1-sided significance level of 0.025 using Nam's RMLE method (margin=0.1).|Difference between PET MPI and SPECT MPI|11.6|||<|0.0001|TWO_SIDED|95.0|2.1|21.1|||Nam's RMLE|||Reader 2: Specificity||21.1|2.1|<0.0001
72428815|NCT03257995|144368732|OTHER||Mean Difference (Final Values)|-0.0398|||||TWO_SIDED|95.0|-0.0942|0.0147|||ANOVA|||||0.0147|-0.0942|
72428816|NCT03257995|144368738|OTHER||Median Difference (Final Values)|-0.02||||0.823|TWO_SIDED|95.0|-0.83|0.33|||Wilcoxon (Mann-Whitney)|||||0.33|-0.83|0.823
72428817|NCT03257995|144368738|OTHER||Median Difference (Final Values)|-0.02||||0.801|TWO_SIDED|95.0|-0.82|0.51|||Wilcoxon (Mann-Whitney)|||||0.51|-0.82|0.801
72428818|NCT03257995|144368738|OTHER||Median Difference (Final Values)|0.0||||0.984|TWO_SIDED|95.0|-0.5|0.73|||Wilcoxon (Mann-Whitney)|||||0.73|-0.50|0.984
72428819|NCT03257995|144368739|OTHER||Mean Difference (Final Values)|0.2177|||<|0.001|TWO_SIDED|95.0|0.1482|0.2872|||ANOVA|||at 5 min||0.2872|0.1482|<0.001
72428820|NCT03257995|144368739|OTHER||Mean Difference (Final Values)|0.2724|||<|0.001|TWO_SIDED|95.0|0.203|0.3417|||ANOVA|||15min||0.3417|0.2030|<0.001
72428821|NCT03257995|144368739|OTHER||Mean Difference (Final Values)|0.273|||<|0.001|TWO_SIDED|95.0|0.2036|0.3423|||ANOVA|||30 min||0.3423|0.2036|<0.001
72428822|NCT03257995|144368739|OTHER||Mean Difference (Final Values)|0.2609|||<|0.001|TWO_SIDED|95.0|0.1915|0.3302|||ANOVA|||1 hour||0.3302|0.1915|<0.001
72428823|NCT03257995|144368739|OTHER||Mean Difference (Final Values)|0.2494|||<|0.001|TWO_SIDED|95.0|0.18|0.3188|||ANOVA|||2 hour||0.3188|0.1800|<0.001
72428824|NCT03257995|144368739|OTHER||Mean Difference (Final Values)|0.2273|||<|0.001|TWO_SIDED|95.0|0.1578|0.2968|||ANOVA|||4 hour||0.2968|0.1578|<0.001
72428825|NCT03257995|144368739|OTHER||Mean Difference (Final Values)|0.2396|||<|0.001|TWO_SIDED|95.0|0.1697|0.3096|||ANOVA|||8 hour||0.3096|0.1697|<0.001
72428826|NCT03257995|144368739|OTHER||Mean Difference (Final Values)|0.2443|||<|0.001|TWO_SIDED|95.0|0.1742|0.3144|||ANOVA|||12 hour||0.3144|0.1742|<0.001
72428827|NCT03257995|144368739|OTHER||Mean Difference (Final Values)|0.228|||<|0.001|TWO_SIDED|95.0|0.1563|0.2997|||ANOVA|||23 hour 15 min||0.2997|0.1563|<0.001
72428828|NCT03257995|144368739|OTHER||Mean Difference (Final Values)|0.1954|||<|0.001|TWO_SIDED|95.0|0.1237|0.2671|||ANOVA|||23 hour 45 min||0.2671|0.1237|<0.001
72428829|NCT03257995|144368739|OTHER||Mean Difference (Final Values)|0.2195|||<|0.001|TWO_SIDED|95.0|0.1502|0.2889|||ANOVA|||5 min||0.2889|0.1502|<0.001
72428830|NCT03257995|144368739|OTHER||Mean Difference (Final Values)|0.2684|||<|0.001|TWO_SIDED|95.0|0.1988|0.338|||ANOVA|||15 min||0.3380|0.1988|<0.001
72428831|NCT03257995|144368739|OTHER||Mean Difference (Final Values)|0.2572|||<|0.001|TWO_SIDED|95.0|0.1879|0.3266|||ANOVA|||30 min||0.3266|0.1879|<0.001
72428832|NCT03257995|144368739|OTHER||Mean Difference (Final Values)|0.2348|||<|0.001|TWO_SIDED|95.0|0.1656|0.304|||ANOVA|||1 hour||0.3040|0.1656|<0.001
72428833|NCT03257995|144368739|OTHER||Mean Difference (Final Values)|0.2546|||<|0.001|TWO_SIDED|95.0|0.1852|0.3239|||ANOVA|||2 hour||0.3239|0.1852|<0.001
72428834|NCT03257995|144368739|OTHER||Mean Difference (Final Values)|0.2322|||<|0.001|TWO_SIDED|95.0|0.1627|0.3017|||ANOVA|||4 hour||0.3017|0.1627|<0.001
72345101|NCT03354273|144213299|SUPERIORITY|The test of sensitivity comparison between Flurpiridaz (18F) Injection PET MPI and SPECT MPI was performed with a 1-sided McNemar's test at a significance level of 0.025 using 1-sided McNemar's tests.|Difference between PET MPI and SPECT MPI|13.7||||0.0017|TWO_SIDED|95.0|3.8|23.5|||McNemar|||Reader 3: Sensitivity||23.5|3.8|0.0017
72345102|NCT03354273|144213299|NON_INFERIORITY|The test of specificity noninferiority between Flurpiridaz (18F) Injection PET MPI and SPECT MPI was performed with a paired test for noninferiority at a 1-sided significance level of 0.025 using Nam's RMLE method (margin=0.1).|Difference between PET MPI and SPECT MPI|2.8||||0.0034|TWO_SIDED|95.0|-6.6|12.1|||Nam's RMLE|||Reader 3: Specificity||12.1|-6.6|0.0034
72345103|NCT03354273|144213299|SUPERIORITY|The test of sensitivity comparison between Flurpiridaz (18F) Injection PET MPI and SPECT MPI was performed with a 1-sided McNemar's test at a significance level of 0.025 using 1-sided McNemar's tests.|Difference between PET MPI and SPECT MPI|7.7||||0.0641|TWO_SIDED|95.0|-3.6|19.0|||McNemar|||Majority Rule: Sensitivity||19.0|-3.6|0.0641
72345104|NCT03354273|144213299|NON_INFERIORITY|The test of specificity noninferiority between Flurpiridaz (18F) Injection PET MPI and SPECT MPI was performed with a paired test for noninferiority at a 1-sided significance level of 0.025 using Nam's RMLE method (margin=0.1).|Difference between PET MPI and SPECT MPI|5.0||||0.001|TWO_SIDED|95.0|-4.6|14.6|||Nam's RMLE|||Majority Rule: Specificity||14.6|-4.6|0.0010
72345105|NCT03354273|144213300|SUPERIORITY|The test of sensitivity comparison between Flurpiridaz (18F) Injection PET MPI and SPECT MPI was performed with a 1-sided McNemar's test at a significance level of 0.025 using 1-sided McNemar's tests.|Difference between PET MPI and SPECT MPI|11.0||||0.0294|TWO_SIDED|95.0|-2.6|24.6|||McNemar|||Reader 1: Sensitivity||24.6|-2.6|0.0294
72345106|NCT03354273|144213300|NON_INFERIORITY|The test of specificity noninferiority between Flurpiridaz (18F) Injection PET MPI and SPECT MPI was performed with a paired test for noninferiority at a 1-sided significance level of 0.025 using Nam's RMLE method (margin=0.1).|Difference between PET MPI and SPECT MPI|3.9||||0.0117|TWO_SIDED|95.0|-8.3|16.1|||Nam's RMLE|||Reader 1: Specificity||16.1|-8.3|0.0117
72345107|NCT03354273|144213300|SUPERIORITY|The test of sensitivity comparison between Flurpiridaz (18F) Injection PET MPI and SPECT MPI was performed with a 1-sided McNemar's test at a significance level of 0.025 using 1-sided McNemar's tests.|Difference between PET MPI and SPECT MPI|6.6||||0.1444|TWO_SIDED|95.0|-7.1|20.3|||McNemar|||Reader 2: Sensitivity||20.3|-7.1|0.1444
72345108|NCT03354273|144213300|NON_INFERIORITY|The test of specificity noninferiority between Flurpiridaz (18F) Injection PET MPI and SPECT MPI was performed with a paired test for noninferiority at a 1-sided significance level of 0.025 using Nam's RMLE method (margin=0.1).|Difference between PET MPI and SPECT MPI|11.7||||0.0001|TWO_SIDED|95.0|-0.4|23.7|||Nam's RMLE|||Reader 2: Specificity||23.7|-0.4|0.0001
72345109|NCT03354273|144213300|SUPERIORITY|The test of sensitivity comparison between Flurpiridaz (18F) Injection PET MPI and SPECT MPI was performed with a 1-sided McNemar's test at a significance level of 0.025 using 1-sided McNemar's tests.|Difference between PET MPI and SPECT MPI|8.8||||0.044|TWO_SIDED|95.0|-1.3|18.9|||McNemar|||Reader 3: Sensitivity||18.9|-1.3|0.0440
72345110|NCT03354273|144213300|NON_INFERIORITY|The test of specificity noninferiority between Flurpiridaz (18F) Injection PET MPI and SPECT MPI was performed with a paired test for noninferiority at a 1-sided significance level of 0.025 using Nam's RMLE method (margin=0.1).|Difference between PET MPI and SPECT MPI|7.8||||0.0022|TWO_SIDED|95.0|-4.8|20.3|||Nam's RMLE|||Reader 3: Specificity||20.3|-4.8|0.0022
72345111|NCT03354273|144213300|SUPERIORITY|The test of sensitivity comparison between Flurpiridaz (18F) Injection PET MPI and SPECT MPI was performed with a 1-sided McNemar's test at a significance level of 0.025 using 1-sided McNemar's tests.|Difference between PET MPI and SPECT MPI|4.4||||0.2164|TWO_SIDED|95.0|-8.4|17.2|||McNemar|||Majority Rule: Sensitivity||17.2|-8.4|0.2164
72428835|NCT03257995|144368739|OTHER||Mean Difference (Final Values)|0.2324|||<|0.001|TWO_SIDED|95.0|0.1627|0.302|||ANOVA|||8 hour||0.3020|0.1627|<0.001
72345112|NCT03354273|144213300|NON_INFERIORITY|The test of specificity noninferiority between Flurpiridaz (18F) Injection PET MPI and SPECT MPI was performed with a paired test for noninferiority at a 1-sided significance level of 0.025 using Nam's RMLE method (margin=0.1).|Difference between PET MPI and SPECT MPI|9.7||||0.0006|TWO_SIDED|95.0|-2.6|22.0|||Nam's RMLE|||Majority Rule: Specificity||22.0|-2.6|0.0006
72345113|NCT00741013|144213322|SUPERIORITY_OR_OTHER||||||<|0.05||95.0||||Only a single statistical analysis was performed upon completion of the study.|ANOVA|||One-way analysis of variance was performed to determine whether lovastatin or rhAPC effectively reduced endotoxin-induced lung inflammation.||||<0.05
72428836|NCT03257995|144368739|OTHER||Mean Difference (Final Values)|0.2057|||<|0.001|TWO_SIDED|95.0|0.1359|0.2755|||ANOVA|||12 hour||0.2755|0.1359|<0.001
72428837|NCT03257995|144368739|OTHER||Mean Difference (Final Values)|0.1625|||<|0.001|TWO_SIDED|95.0|0.0912|0.2337|||ANOVA|||23 hour 15 min||0.2337|0.0912|<0.001
72345114|NCT01357551|144213330|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.61|STANDARD_ERROR_OF_MEAN|0.78||0.04|TWO_SIDED|95.0|0.07|3.13||A priori threshold was p\<.05|Mixed Models Analysis|Parameters included common intercept, initial weight loss stratum, dummy-coded time, and indicators for the maintenance X each follow-up time point||The sample size estimate was based on the primary hypothesis that patients randomized to receive the maintenance intervention would have less mean weight regain at week 56 than those randomized to usual care. The week 0 standard deviation was estimated as 24.6kg, the correlation between week 0 and week 56 as 0.95, and the week 56 dropout rate as 10%. To detect a difference of 3.5 kg with 90% power and a type I error rate of 5%, 230 total (115 in each group) randomized patients were needed.||3.13|.07|.04
72428838|NCT03257995|144368739|OTHER||Mean Difference (Final Values)|0.1793|||<|0.001|TWO_SIDED|95.0|0.108|0.2505|||ANOVA|||23 hour 45 min||0.2505|0.1080|<0.001
72428839|NCT03257995|144368740|OTHER||Mean Difference (Final Values)|7.1|||<|0.001|TWO_SIDED|95.0|5.0|9.2|||ANOVA|||at 5 min||9.2|5.0|<.001
72428840|NCT03257995|144368740|OTHER||Mean Difference (Final Values)|8.5|||<|0.001|TWO_SIDED|95.0|6.4|10.6|||ANOVA|||at 15 min||10.6|6.4|<.001
72428841|NCT03257995|144368740|OTHER||Mean Difference (Final Values)|8.6|||<|0.001|TWO_SIDED|95.0|6.5|10.7|||ANOVA|||at 30||10.7|6.5|<0.001
72428842|NCT03257995|144368740|OTHER||Mean Difference (Final Values)|8.0|||<|0.001|TWO_SIDED|95.0|6.0|10.1|||ANOVA|||at 1 hour||10.1|6.0|<0.001
72428843|NCT03257995|144368740|OTHER||Mean Difference (Final Values)|7.6|||<|0.001|TWO_SIDED|95.0|5.5|9.7|||ANOVA|||at 2 hours||9.7|5.5|<0.001
72345115|NCT01357551|144213331|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-125.49|STANDARD_ERROR_OF_MEAN|78.64||0.11|TWO_SIDED|95.0|-280.71|29.72|||Mixed Models Analysis|Common intercept, initial weight loss stratum, indicators for week 26 \& 56, group X time interaction||The hypothesis was that patients randomized to receive the maintenance intervention would have less caloric intake at week 56 than those randomized to usual care.||29.72|-280.71|.11
72345116|NCT01357551|144213332|SUPERIORITY_OR_OTHER||incidence rate ratio|1.03|STANDARD_ERROR_OF_MEAN|0.26||0.91|TWO_SIDED|95.0|0.63|1.68|||Mixed Models Analysis|Common intercept, initial weight loss stratum, indicators for week 26 \& 56, group X time interaction; negative binomial distribution with log link||The hypothesis was that patients randomized to receive the maintenance intervention would have higher rates of walking per week at week 56 than those randomized to usual care.||1.68|0.63|.91
72345117|NCT01357551|144213333|SUPERIORITY_OR_OTHER||incidence rate ratio|1.07|STANDARD_ERROR_OF_MEAN|0.35||0.83|TWO_SIDED|95.0|0.57|2.03|||Mixed Models Analysis|Common intercept, initial weight loss stratum, indicators for week 26 \& 56, group X time interaction; negative binomial distribution with log link||The hypothesis was that patients randomized to receive the maintenance intervention would have higher rates of moderate physical activity per week at week 56 than those randomized to usual care.||2.03|0.57|.83
72345118|NCT00921843|144213338|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<0.05
72345119|NCT02870101|144213339|OTHER|Estimated positive percent agreement (PPA) defined as: (Index Test Positive; ASIS Positive) / (Index Test Negative; ASIS Positive + Index Test Positive; ASIS Positive + Index Test Negative; ASIS Indeterminate)|PPA|94.7|||||TWO_SIDED|95.0|90.7|97.0|||||PPA estimated with two-sided 95% score confidence interval.|||97.0|90.7|
72345120|NCT02870101|144213339|OTHER|Estimated negative percent agreement (NPA) defined as: (Index Test Negative; ASIS Negative) / (Index Test Negative; ASIS Negative + Index Test Positive; ASIS Negative + Index Test Positive; ASIS Indeterminate)|NPA|98.8|||||TWO_SIDED|95.0|98.2|99.1|||||NPA estimated with two-sided 95% score confidence interval.|||99.1|98.2|
72345121|NCT02870101|144213340|OTHER|Estimated positive percent agreement (PPA) defined as: (Index Test Positive; ASIS Positive) / (Index Test Negative; ASIS Positive + Index Test Positive; ASIS Positive + Index Test Negative; ASIS Indeterminate)|PPA|91.2|||||TWO_SIDED|95.0|86.5|94.4|||||PPA estimated with two-sided 95% score confidence interval.|||94.4|86.5|
72345122|NCT02870101|144213340|OTHER|Estimated negative percent agreement (NPA) defined as: (Index Test Negative; ASIS Negative) / (Index Test Negative; ASIS Negative + Index Test Positive; ASIS Negative + Index Test Positive; ASIS Indeterminate)|NPA|99.6|||||TWO_SIDED|95.0|99.3|99.8|||||NPA estimated with two-sided 95% score confidence interval.|||99.8|99.3|
72345123|NCT02870101|144213341|OTHER|Estimated positive percent agreement (PPA) defined as: (Index Test Positive; ASIS Positive) / (Index Test Negative; ASIS Positive + Index Test Positive; ASIS Positive + Index Test Equivocal; ASIS Indeterminate + Index Test Negative; ASIS Indeterminate)|PPA|95.1|||||TWO_SIDED|95.0|91.3|97.3|||||PPA estimated with two-sided 95% score confidence interval.|||97.3|91.3|
72345124|NCT02870101|144213341|OTHER|Estimated negative percent agreement (NPA) defined as: (Index Test Negative; ASIS Negative) / (Index Test Negative; ASIS Negative + Index Test Positive; ASIS Negative + Index Test Equivocal; ASIS Negative + Index Test Positive; ASIS Indeterminate)|NPA|98.8|||||TWO_SIDED|95.0|98.3|99.2|||||NPA estimated with two-sided 95% score confidence interval.|||99.2|98.3|
72345125|NCT02870101|144213342|OTHER|Estimated positive percent agreement (PPA) defined as: (Index Test Positive; ASIS Positive) / (Index Test Negative; ASIS Positive + Index Test Positive; ASIS Positive + Index Test Negative; ASIS Indeterminate)|PPA|96.5|||||TWO_SIDED|95.0|92.9|98.3|||||PPA estimated with two-sided 95% score confidence interval.|||98.3|92.9|
72345126|NCT02870101|144213342|OTHER|Estimated negative percent agreement (NPA) defined as: (Index Test Negative; ASIS Negative) / (Index Test Negative; ASIS Negative + Index Test Positive; ASIS Negative + Index Test Positive; ASIS Indeterminate)|NPA|99.2|||||TWO_SIDED|95.0|98.8|99.5|||||NPA estimated with two-sided 95% score confidence interval.|||99.5|98.8|
72345127|NCT02870101|144213343|OTHER|Estimated positive percent agreement (PPA) defined as: (Index Test Positive; ASIS Positive) / (Index Test Negative; ASIS Positive + Index Test Positive; ASIS Positive + Index Test Negative; ASIS Indeterminate)|PPA|84.8|||||TWO_SIDED|95.0|79.4|89.0|||||PPA estimated with two-sided 95% score confidence interval.|||89.0|79.4|
72345128|NCT02870101|144213343|OTHER|Estimated negative percent agreement (NPA) defined as: (Index Test Negative; ASIS Negative) / (Index Test Negative; ASIS Negative + Index Test Positive; ASIS Negative + Index Test Positive; ASIS Indeterminate)|NPA|99.5|||||TWO_SIDED|95.0|99.2|99.7|||||NPA estimated with two-sided 95% score confidence interval.|||99.7|99.2|
72345129|NCT02870101|144213344|OTHER|Estimated positive percent agreement (PPA) defined as: (Index Test Positive; ASIS Positive) / (Index Test Negative; ASIS Positive + Index Test Positive; ASIS Positive + Index Test Negative; ASIS Indeterminate)|PPA|88.3|||||TWO_SIDED|95.0|83.2|92.0|||||PPA estimated with two-sided 95% score confidence interval.|||92.0|83.2|
72345130|NCT02870101|144213344|OTHER|Estimated negative percent agreement (NPA) defined as: (Index Test Negative; ASIS Negative) / (Index Test Negative; ASIS Negative + Index Test Positive; ASIS Negative + Index Test Positive; ASIS Indeterminate)|NPA|99.6|||||TWO_SIDED|95.0|99.2|99.8|||||NPA estimated with two-sided 95% score confidence interval.|||99.8|99.2|
72345131|NCT02870101|144213345|OTHER|Estimated positive percent agreement (PPA) defined as: (Index Test Positive; ASIS Positive) / (Index Test Negative; ASIS Positive + Index Test Positive; ASIS Positive + Index Test Negative; ASIS Indeterminate)|PPA|95.9|||||TWO_SIDED|95.0|86.3|98.9|||||PPA estimated with two-sided 95% score confidence interval.|||98.9|86.3|
72345132|NCT02870101|144213345|OTHER|Estimated negative percent agreement (NPA) defined as: (Index Test Negative; ASIS Negative) / (Index Test Negative; ASIS Negative + Index Test Positive; ASIS Negative + Index Test Positive; ASIS Indeterminate)|NPA|99.7|||||TWO_SIDED|95.0|99.4|99.8|||||NPA estimated with two-sided 95% score confidence interval.|||99.8|99.4|
72345133|NCT02870101|144213346|OTHER|Estimated positive percent agreement (PPA) defined as: (Index Test Positive; ASIS Positive) / (Index Test Negative; ASIS Positive + Index Test Positive; ASIS Positive + Index Test Negative; ASIS Indeterminate)|PPA|86.0|||||TWO_SIDED|95.0|80.9|89.9|||||PPA estimated with two-sided 95% score confidence interval.|||89.9|80.9|
72345134|NCT02870101|144213346|OTHER|Estimated Negative percent agreement (NPA) defined as: (Index Test Negative; ASIS Negative) / (Index Test Negative; ASIS Negative + Index Test Positive; ASIS Negative + Index Test Positive; ASIS Indeterminate)|NPA|99.3|||||TWO_SIDED|95.0|98.9|99.6|||||NPA estimated with two-sided 95% score confidence interval.|||99.6|98.9|
72345135|NCT02870101|144213347|OTHER|Estimated positive percent agreement (PPA) defined as: (Index Test Positive; ASIS Positive) / (Index Test Negative; ASIS Positive + Index Test Positive; ASIS Positive + Index Test Equivocal; ASIS Indeterminate + Index Test Negative; ASIS Indeterminate)|PPA|88.2|||||TWO_SIDED|95.0|76.6|94.5|||||PPA estimated with two-sided 95% score confidence interval.|||94.5|76.6|
72345136|NCT02870101|144213347|OTHER|Estimated negative percent agreement (NPA) defined as: (Index Test Negative; ASIS Negative) / (Index Test Negative; ASIS Negative + Index Test Positive; ASIS Negative + Index Test Equivocal; ASIS Negative + Index Test Positive; ASIS Indeterminate)|NPA|99.7|||||TWO_SIDED|95.0|99.4|99.8|||||NPA estimated with two-sided 95% score confidence interval.|||99.8|99.4|
72345137|NCT02870101|144213348|OTHER|Estimated positive percent agreement (PPA) defined as: (Index Test Positive; ASIS Positive) / (Index Test Negative; ASIS Positive + Index Test Positive; ASIS Positive + Index Test Equivocal; ASIS Indeterminate + Index Test Negative; ASIS Indeterminate)|PPA|88.7|||||TWO_SIDED|95.0|83.9|92.3|||||PPA estimated with two-sided 95% score confidence interval.|||92.3|83.9|
72345138|NCT02870101|144213348|OTHER|Estimated negative percent agreement (NPA) defined as: (Index Test Negative; ASIS Negative) / (Index Test Negative; ASIS Negative + Index Test Positive; ASIS Negative + Index Test Equivocal; ASIS Negative + Index Test Positive; ASIS Indeterminate)|NPA|98.7|||||TWO_SIDED|95.0|98.2|99.1|||||NPA estimated with two-sided 95% score confidence interval.|||99.1|98.2|
72345139|NCT02870101|144213349|OTHER|Estimated positive percent agreement (PPA) defined as: (Index Test Positive; ASIS Positive) / (Index Test Negative; ASIS Positive + Index Test Positive; ASIS Positive + Index Test Equivocal; ASIS Indeterminate + Index Test Negative; ASIS Indeterminate)|PPA|84.0|||||TWO_SIDED|95.0|71.5|91.7|||||PPA estimated with two-sided 95% score confidence interval.|||91.7|71.5|
72345140|NCT02870101|144213349|OTHER|Estimated negative percent agreement (NPA) defined as: (Index Test Negative; ASIS Negative) / (Index Test Negative; ASIS Negative + Index Test Positive; ASIS Negative + Index Test Equivocal; ASIS Negative + Index Test Positive; ASIS Indeterminate)|NPA|99.8|||||TWO_SIDED|95.0|99.5|99.9|||||NPA estimated with two-sided 95% score confidence interval.|||99.9|99.5|
72345141|NCT02870101|144213350|OTHER|Estimated positive percent agreement (PPA) defined as: (Index Test Positive; ASIS Positive) / (Index Test Negative; ASIS Positive + Index Test Positive; ASIS Positive + Index Test Equivocal; ASIS Indeterminate + Index Test Negative; ASIS Indeterminate)|PPA|83.0|||||TWO_SIDED|95.0|77.6|87.3|||||PPA estimated with two-sided 95% score confidence interval.|||87.3|77.6|
72345142|NCT02870101|144213350|OTHER|Estimated negative percent agreement (NPA) defined as: (Index Test Negative; ASIS Negative) / (Index Test Negative; ASIS Negative + Index Test Positive; ASIS Negative + Index Test Equivocal; ASIS Negative + Index Test Positive; ASIS Indeterminate)|NPA|99.1|||||TWO_SIDED|95.0|98.6|99.4|||||NPA estimated with two-sided 95% score confidence interval.|||99.4|98.6|
72345143|NCT03100058|144213393|OTHER|Dose finding study|Mean Difference (Net)|-1.73|||<|0.0001|TWO_SIDED|95.0|-3.17|-0.29|||ANCOVA|||||-0.29|-3.17|<0.0001
72345144|NCT03100058|144213393|OTHER|Dose finding study|Median Difference (Net)|-1.93|||<|0.0001|TWO_SIDED|95.0|-3.36|-0.5|||ANCOVA|||||-0.50|-3.36|<0.0001
72345145|NCT03100058|144213393|OTHER|Dose finding study|Mean Difference (Net)|-3.3|||<|0.0001|TWO_SIDED|95.0|-4.86|-1.75|||ANCOVA|||||-1.75|-4.86|<0.0001
72345146|NCT03100058|144213393|OTHER|Dose finding study|Mean Difference (Net)|-4.42|||<|0.0001|TWO_SIDED|95.0|-5.39|-3.44|||ANCOVA|||||-3.44|-5.39|<0.0001
72428844|NCT03257995|144368740|OTHER||Mean Difference (Final Values)|7.1|||<|0.001|TWO_SIDED|95.0|5.0|9.1|||ANOVA|||at 4 hours||9.1|5.0|<0.001
72345147|NCT03100058|144213393|OTHER|Dose finding study|Mean Difference (Net)|-1.14|||<|0.0001|TWO_SIDED|95.0|-2.53|-0.25|||ANCOVA|||||-0.25|-2.53|<0.0001
72345148|NCT03100058|144213393|OTHER|Dose finding study|Mean Difference (Net)|-2.74|||<|0.0001|TWO_SIDED|95.0|-4.11|-1.36|||ANCOVA|||||-1.36|-4.11|<0.0001
72345149|NCT03100058|144213393|OTHER|Dose finding study|Mean Difference (Net)|-4.11|||<|0.0001|TWO_SIDED|95.0|-5.54|-2.68|||ANCOVA|||||-2.68|-5.54|<0.0001
72345150|NCT03100058|144213393|OTHER|Dose finding study|Mean Difference (Net)|-4.48|||<|0.0001|TWO_SIDED|95.0|-5.54|-3.43|||ANCOVA|||||-3.43|-5.54|<0.0001
72345151|NCT03100058|144213394|OTHER|Dose finding study|Odds Ratio (OR)|2.38||||0.099|TWO_SIDED|95.0|0.85|6.67|||ANCOVA|||\>=5%||6.67|0.85|0.099
72345152|NCT03100058|144213394|OTHER|Dose finding study|Odds Ratio, log|1.18||||0.779|TWO_SIDED|95.0|0.36|3.84|||ANCOVA|||\>=5%||3.84|0.36|0.779
72345153|NCT03100058|144213394|OTHER|Dose finding study|Odds Ratio (OR)|3.69||||0.011|TWO_SIDED|95.0|1.35|10.11|||ANCOVA|||\>=5%||10.11|1.35|0.011
72428845|NCT03257995|144368740|OTHER||Mean Difference (Final Values)|7.3|||<|0.001|TWO_SIDED|95.0|5.2|9.4|||ANOVA|||at 8 hours||9.4|5.2|<0.001
72428846|NCT03257995|144368740|OTHER||Mean Difference (Final Values)|7.6|||<|0.001|TWO_SIDED|95.0|5.5|9.7|||ANOVA|||at 12 hours||9.7|5.5|<0.001
72428847|NCT03257995|144368740|OTHER||Mean Difference (Final Values)|7.0|||<|0.001|TWO_SIDED|95.0|4.8|9.1|||ANOVA|||at 23 hours 15 min||9.1|4.8|<0.001
72345154|NCT03100058|144213394|OTHER|Dose finding study|Odds Ratio (OR)|5.57|||<|0.001|TWO_SIDED|95.0|2.41|12.88|||ANCOVA|||\>=5%||12.88|2.41|<.001
72345155|NCT03100058|144213394|OTHER|Dose finding study|Odds Ratio (OR)|1.15||||0.812|TWO_SIDED|95.0|0.36|3.74|||ANCOVA|||\>=5%||3.74|0.36|0.812
72345156|NCT03100058|144213394|OTHER|Dose finding study|Odds Ratio (OR)|1.94||||0.229|TWO_SIDED|95.0|0.66|5.69|||ANCOVA|||\>=5%||5.69|0.66|0.229
72345157|NCT03100058|144213394|OTHER|Dose finding study|Odds Ratio (OR)|4.29||||0.004|TWO_SIDED|95.0|1.61|11.46|||ANCOVA|||\>=5%||11.46|1.61|0.004
72345158|NCT03100058|144213394|OTHER|Dose finding study|Odds Ratio (OR)|6.37|||<|0.001|TWO_SIDED|95.0|2.72|14.93|||ANCOVA|||\>=5%||14.93|2.72|<.001
72345159|NCT03100058|144213394|OTHER|Dose finding study|Odds Ratio (OR)|1.09||||0.943|TWO_SIDED|95.0|0.1|12.41|||ANCOVA|||\>=10%||12.41|0.10|0.943
72345160|NCT03100058|144213394|OTHER|Dose finding study|Odds Ratio (OR)|2.11||||0.465|TWO_SIDED|95.0|0.28|15.77|||ANCOVA|||\>=10%||15.77|0.28|0.465
72428848|NCT03257995|144368740|OTHER||Mean Difference (Final Values)|6.4|||<|0.001|TWO_SIDED|95.0|4.2|8.6|||ANOVA|||at 23 hours 45 min||8.6|4.2|<0.001
72428849|NCT03257995|144368740|OTHER||Mean Difference (Final Values)|7.1|||<|0.001|TWO_SIDED|95.0|5.0|9.2|||ANOVA|||at 5 min||9.2|5.0|<0.001
72428850|NCT03257995|144368740|OTHER||Mean Difference (Final Values)|8.3|||<|0.001|TWO_SIDED|95.0|6.2|10.4|||ANOVA|||at 15 min||10.4|6.2|<0.001
72428851|NCT03257995|144368740|OTHER||Mean Difference (Final Values)|8.1|||<|0.001|TWO_SIDED|95.0|6.0|10.2|||ANOVA|||at 30 min||10.2|6.0|<0.001
72345161|NCT03100058|144213394|OTHER|Dose finding study|Odds Ratio (OR)|1.6||||0.696|TWO_SIDED|95.0|0.15|17.15|||ANCOVA|||\>=10%||17.15|0.15|0.696
72345162|NCT03100058|144213394|OTHER|Dose finding study|Odds Ratio (OR)|2.14||||0.389|TWO_SIDED|95.0|0.38|12.1|||ANCOVA|||\>=10%||12.10|0.38|0.389
72345163|NCT03100058|144213394|OTHER|Dose finding study|Odds Ratio (OR)|1.04||||0.976|TWO_SIDED|95.0|0.09|11.87|||ANCOVA|||\>=10%||11.87|0.09|0.976
72345164|NCT03100058|144213394|OTHER|Dose finding study|Odds Ratio (OR)|1.02||||0.986|TWO_SIDED|95.0|0.09|11.7|||ANCOVA|||\>=10%||11.70|0.09|0.986
72345165|NCT03100058|144213394|OTHER|Dose finding study|Odds Ratio (OR)|3.51||||0.181|TWO_SIDED|95.0|0.56|22.18|||ANCOVA|||\>=10%||22.18|0.56|0.181
72345166|NCT03100058|144213394|OTHER|Dose finding study|Odds Ratio (OR)|3.97||||0.1|TWO_SIDED|95.0|0.77|20.54|||ANCOVA|||\>=10%||20.54|0.77|0.100
72345167|NCT03100058|144213395|OTHER|Dose finding study|Odds Ratio (OR)|6.29||||0.048|TWO_SIDED|95.0|1.02|38.76|||ANCOVA|||\>=5% (Dysglycemic)||38.76|1.02|0.048
72428852|NCT03257995|144368740|OTHER||Mean Difference (Final Values)|7.4|||<|0.001|TWO_SIDED|95.0|5.3|9.4|||ANOVA|||at 1 hour||9.4|5.3|<0.001
72428853|NCT03257995|144368740|OTHER||Mean Difference (Final Values)|7.8|||<|0.001|TWO_SIDED|95.0|5.7|9.9|||ANOVA|||at 2 hours||9.9|5.7|<0.001
72345168|NCT03100058|144213395|OTHER|Dose finding study|Odds Ratio, log|3.94||||0.171|TWO_SIDED|95.0|0.55|28.03|||ANCOVA|||\>=5% (Dsyglycemic)||28.03|0.55|0.171
72345169|NCT03100058|144213395|OTHER|Dose finding study|Odds Ratio (OR)|7.17||||0.041|TWO_SIDED|95.0|1.09|47.27|||ANCOVA|||\>=5% (Dysglycemic)||47.27|1.09|0.041
72345170|NCT03100058|144213395|OTHER|Dose finding study|Odds Ratio (OR)|11.89||||0.003|TWO_SIDED|95.0|2.32|60.93|||ANCOVA|||\>=5% (Dysglycemic)||60.93|2.32|0.003
72345171|NCT03100058|144213395|OTHER|Dose finding study|Odds Ratio (OR)|0.96||||0.976|TWO_SIDED|95.0|0.08|11.72|||ANCOVA|||\>=5% (Dysglycemic)||11.72|0.08|0.976
72345172|NCT03100058|144213395|OTHER|Dose finding study|Odds Ratio (OR)|8.78||||0.022|TWO_SIDED|95.0|1.37|56.44|||ANCOVA|||\>=5% (Dysglycemic)||56.44|1.37|0.022
72345173|NCT03100058|144213395|OTHER|Dose finding study|Odds Ratio (OR)|7.5||||0.032|TWO_SIDED|95.0|1.2|46.99|||ANCOVA|||\>=5% (Dysglycemic)||46.99|1.20|0.032
72345174|NCT03100058|144213395|OTHER|Dose finding study|Odds Ratio (OR)|11.28||||0.005|TWO_SIDED|95.0|2.11|60.46|||ANCOVA|||\>=5% (Dysglycemic)||60.46|2.11|0.005
72345175|NCT03100058|144213395|OTHER|Dose finding study|Odds Ratio (OR)|3.21||||0.227|TWO_SIDED|95.0|0.48|21.28|||ANCOVA|||\>=5% (Normoglycemic)||21.28|0.48|0.227
72345176|NCT03100058|144213395|OTHER|Dose finding study|Odds Ratio (OR)|0.69||||0.763|TWO_SIDED|95.0|0.06|7.85|||ANCOVA|||\>=5% (Normoglycemic)||7.85|0.06|0.763
72345177|NCT03100058|144213395|OTHER|Dose finding study|Odds Ratio (OR)|4.68||||0.095|TWO_SIDED|95.0|0.76|28.7|||ANCOVA|||\>=5% (Normoglycemic)||28.70|0.76|0.095
72345178|NCT03100058|144213395|OTHER|Dose finding study|Odds Ratio (OR)|5.33||||0.033|TWO_SIDED|95.0|1.14|24.83|||ANCOVA|||\>=5% (Normoglycemic)||24.83|1.14|0.033
72345179|NCT03100058|144213395|OTHER|Dose finding study|Odds Ratio (OR)|0.72||||0.788|TWO_SIDED|95.0|0.06|8.1|||ANCOVA|||\>=5% (Normoglycemic)||8.10|0.06|0.788
72345180|NCT03100058|144213395|OTHER|Dose finding study|Odds Ratio (OR)|0.68||||0.751|TWO_SIDED|95.0|0.06|7.62|||ANCOVA|||\>=5% (Normoglycemic)||7.62|0.06|0.751
72345181|NCT03100058|144213395|OTHER|Dose finding study|Odds Ratio (OR)|8.05||||0.027|TWO_SIDED|95.0|1.27|51.09|||ANCOVA|||\>=5% (Normoglycemic)||51.09|1.27|0.027
72345182|NCT03100058|144213395|OTHER|Dose finding study|Odds Ratio (OR)|6.64||||0.023|TWO_SIDED|95.0|1.3|34.0|||ANCOVA|||\>=5% (Normoglycemic)||34.00|1.30|0.023
72345183|NCT03100058|144213395|OTHER|Dose finding study|Odds Ratio (OR)|0.48||||0.528|TWO_SIDED|95.0|0.05|4.78|||ANCOVA|||\>=5% (T2DM)||4.78|0.05|0.528
72345184|NCT03100058|144213395|OTHER|Dose finding study|Odds Ratio (OR)|1.05||||0.958|TWO_SIDED|95.0|0.17|6.68|||ANCOVA|||\>=5% (T2DM)||6.68|0.17|0.958
72345185|NCT03100058|144213395|OTHER|Dose finding study|Odds Ratio (OR)|1.7||||0.546|TWO_SIDED|95.0|0.3|9.49|||ANCOVA|||\>=5% (T2DM)||9.49|0.30|0.546
72345186|NCT03100058|144213395|OTHER|Dose finding test|Odds Ratio (OR)|3.09||||0.098|TWO_SIDED|95.0|0.81|11.75|||ANCOVA|||\>=5% (T2DM)||11.75|0.81|0.098
72345187|NCT03100058|144213395|OTHER|Dose finding study|Odds Ratio (OR)|1.64||||0.563|TWO_SIDED|95.0|0.31|8.7|||ANCOVA|||\>=5% (T2DM)||8.70|0.31|0.563
72345188|NCT03100058|144213395|OTHER|Dose finding study|Odds Ratio (OR)|0.55||||0.61|TWO_SIDED|95.0|0.06|5.38|||ANCOVA|||\>=5% (T2DM)||5.38|0.06|0.610
72345189|NCT03100058|144213395|OTHER|Dose finding study|Odds Ratio (OR)|1.71||||0.528|TWO_SIDED|95.0|0.32|9.16|||ANCOVA|||\>=5% (T2DM)||9.16|0.32|0.528
72345190|NCT03100058|144213395|OTHER|Dose finding study|Odds Ratio (OR)|4.55||||0.023|TWO_SIDED|95.0|1.23|16.9|||ANCOVA|||\>=5% (T2DM)||16.90|1.23|0.023
72345191|NCT03100058|144213396|OTHER|Dose finding study|Median Difference (Net)|-0.8||||0.47|TWO_SIDED|95.0|-2.96|1.37|||ANCOVA|||||1.37|-2.96|0.470
72345192|NCT03100058|144213396|OTHER|Dose finding study|Median Difference (Net)|-1.4||||0.199|TWO_SIDED|95.0|-3.64|0.76|||ANCOVA|||||0.76|-3.64|0.199
72345193|NCT03100058|144213396|OTHER|Dose finding study|Median Difference (Net)|-1.4|||<|0.001|TWO_SIDED|95.0|-3.64|0.76|||ANCOVA|||||0.76|-3.64|<0.001
72345194|NCT03100058|144213396|OTHER|Dose finding study|Mean Difference (Net)|-1.4||||0.206|TWO_SIDED|95.0|-3.56|0.77|||ANCOVA|||||0.77|-3.56|0.206
72345195|NCT03100058|144213396|OTHER|Dose finding study|Median Difference (Net)|-3.0||||0.006|TWO_SIDED|95.0|-5.18|-0.88|||ANCOVA|||||-0.88|-5.18|0.006
72345196|NCT03100058|144213396|OTHER|Dose finding study|Median Difference (Net)|-3.5||||0.002|TWO_SIDED|95.0|-5.7|-1.3|||ANCOVA|||||-1.30|-5.70|0.002
72345197|NCT03100058|144213396|OTHER|Dose finding study|Mean Difference (Net)|-3.3|||<|0.001|TWO_SIDED|95.0|-5.1|-1.51|||ANCOVA|||||-1.51|-5.10|<0.001
72345198|NCT03100058|144213396|OTHER|Dose finding study|Median Difference (Net)|-0.9||||0.391|TWO_SIDED|95.0|-2.82|1.1|||ANCOVA|||||1.10|-2.82|0.391
72345199|NCT03100058|144213396|OTHER|Dose finding study|Median Difference (Net)|-2.5||||0.259|TWO_SIDED|95.0|-3.1|0.84|||ANCOVA|||||0.84|-3.10|0.259
72345200|NCT03100058|144213396|OTHER|Dose finding study|Mean Difference (Net)|-2.5||||0.048|TWO_SIDED|95.0|-4.91|-0.02|||ANCOVA|||||-0.02|-4.91|0.048
72428854|NCT03257995|144368740|OTHER||Mean Difference (Final Values)|7.3|||<|0.001|TWO_SIDED|95.0|5.2|9.4|||ANOVA|||at 4 hours||9.4|5.2|<0.001
72428855|NCT03257995|144368740|OTHER||Mean Difference (Final Values)|7.4|||<|0.001|TWO_SIDED|95.0|5.3|9.5|||ANOVA|||at 8 hours||9.5|5.3|<0.001
72345201|NCT03100058|144213397|OTHER|Dose finding study|Mean Difference (Net)|1.0||||0.225|TWO_SIDED|95.0|-0.62|2.61|||ANCOVA|||||2.61|-0.62|0.225
72345202|NCT03100058|144213397|OTHER|Dose finding study|Mean Difference (Net)|-1.0||||0.247|TWO_SIDED|95.0|-2.62|0.68|||ANCOVA|||||0.68|-2.62|0.247
72345203|NCT03100058|144213397|OTHER|Dose finding study|Median Difference (Net)|-2.0||||0.019|TWO_SIDED|95.0|-3.75|-0.34|||ANCOVA|||||-0.34|-3.75|0.019
72345204|NCT03100058|144213397|OTHER|Dose finding study|Mean Difference (Net)|-1.6||||0.015|TWO_SIDED|95.0|-2.96|-0.33|||ANCOVA|||||-0.33|-2.96|0.015
72345205|NCT03100058|144213397|OTHER|Dose finding study|Mean Difference (Net)|-1.3||||0.106|TWO_SIDED|95.0|-2.97|0.29|||ANCOVA|||||0.29|-2.97|0.106
72345206|NCT03100058|144213397|OTHER|Dose finding study|Mean Difference (Net)|-1.9||||0.02|TWO_SIDED|95.0|-3.54|-0.31|||ANCOVA|||||-0.31|-3.54|0.020
72345207|NCT03100058|144213397|OTHER|Dose finding study|Mean Difference (Net)|-1.8||||0.035|TWO_SIDED|95.0|-3.44|-0.12|||ANCOVA|||||-0.12|-3.44|0.035
72345208|NCT03100058|144213397|OTHER|Dose finding study|Mean Difference (Net)|-1.9||||0.004|TWO_SIDED|95.0|-3.22|-0.61|||ANCOVA|||||-0.61|-3.22|0.004
72345209|NCT03100058|144213398|OTHER|Dose finding study|Mean Difference (Net)|0.4||||0.082|TWO_SIDED|95.0|-0.05|0.79|||ANCOVA|||||0.79|-0.05|0.082
72345210|NCT03100058|144213398|OTHER|Dose finding study|Median Difference (Net)|-0.2||||0.319|TWO_SIDED|95.0|-0.63|0.21|||ANCOVA|||||0.21|-0.63|0.319
72345211|NCT03100058|144213398|OTHER|Dose finding study|Mean Difference (Net)|-0.4||||0.008|TWO_SIDED|95.0|-1.05|-0.16|||ANCOVA|||||-0.16|-1.05|0.008
72345212|NCT03100058|144213398|OTHER|Dose finding study|Mean Difference (Net)|-0.4||||0.015|TWO_SIDED|95.0|-0.76|-0.08|||ANCOVA|||||-0.08|-0.76|0.015
72428856|NCT03257995|144368740|OTHER||Mean Difference (Final Values)|6.3|||<|0.001|TWO_SIDED|95.0|4.2|8.4|||ANOVA|||at 12 hours||8.4|4.2|<0.001
72345213|NCT03100058|144213398|OTHER|Dose finding study|Mean Difference (Net)|-0.1||||0.707|TWO_SIDED|95.0|-0.5|0.34|||ANCOVA|||||0.34|-0.50|0.707
72345214|NCT03100058|144213398|OTHER|Dose finding study|Mean Difference (Net)|-0.2||||0.28|TWO_SIDED|95.0|-0.65|0.19|||ANCOVA|||||0.19|-0.65|0.280
72345215|NCT03100058|144213398|OTHER|Dose finding study|Mean Difference (Net)|-0.4||||0.086|TWO_SIDED|95.0|-0.8|0.05|||ANCOVA|||||0.05|-0.80|0.086
72345216|NCT03100058|144213398|OTHER|Dose finding study|Mean Difference (Net)|-0.4||||0.03|TWO_SIDED|95.0|-0.72|-0.04|||ANCOVA|||||-0.04|-0.72|0.030
72345217|NCT03100058|144213399|OTHER|Dose finding study|Mean Difference (Net)|-2.8||||0.156|TWO_SIDED|95.0|-6.64|1.07|||ANCOVA|||SBP||1.07|-6.64|0.156
72345218|NCT03100058|144213399|OTHER|Dose finding study|Mean Difference (Net)|-3.1||||0.127|TWO_SIDED|95.0|-7.11|0.89|||ANCOVA|||SBP||0.89|-7.11|0.127
72345219|NCT03100058|144213399|OTHER|Dose finding study|Mean Difference (Net)|-6.5||||0.002|TWO_SIDED|95.0|-10.52|-2.42|||ANCOVA|||SBP||-2.42|-10.52|0.002
72345220|NCT03100058|144213399|OTHER|Dose finding study|Mean Difference (Net)|-2.7||||0.089|TWO_SIDED|95.0|-5.86|0.42|||ANCOVA|||SBP||0.42|-5.86|0.089
72345221|NCT03100058|144213399|OTHER|Dose finding study|Mean Difference (Net)|-2.3||||0.245|TWO_SIDED|95.0|-6.12|1.57|||ANCOVA|||SBP||1.57|-6.12|0.245
72345222|NCT03100058|144213399|OTHER|Dose finding study|Mean Difference (Net)|-0.8||||0.678|TWO_SIDED|95.0|-4.65|3.02|||ANCOVA|||SBP||3.02|-4.65|0.678
72345223|NCT03100058|144213399|OTHER|Dose finding study|Mean Difference (Net)|-4.1||||0.04|TWO_SIDED|95.0|-8.07|-0.19|||ANCOVA|||SBP||-0.19|-8.07|0.040
72345224|NCT03100058|144213399|OTHER|Dose finding study|Mean Difference (Net)|-3.4||||0.038|TWO_SIDED|95.0|-6.61|-0.19|||ANCOVA|||SBP||-0.19|-6.61|0.038
72345225|NCT03100058|144213399|OTHER|Dose finding study|Mean Difference (Net)|-0.7||||0.601|TWO_SIDED|95.0|-3.38|1.96|||ANCOVA|||DBP||1.96|-3.38|0.601
72345226|NCT03100058|144213399|OTHER|Dose finding study|Mean Difference (Net)|-0.4||||0.76|TWO_SIDED|95.0|-3.2|2.34|||ANCOVA|||DBP||2.34|-3.20|0.760
72345227|NCT03100058|144213399|OTHER|Dose finding study|Mean Difference (Net)|-2.8||||0.051|TWO_SIDED|95.0|-5.6|0.01|||ANCOVA|||DBP||0.01|-5.60|0.051
72345228|NCT03100058|144213399|OTHER|Dose finding study|Mean Difference (Net)|-1.8||||0.105|TWO_SIDED|95.0|-3.98|0.38|||ANCOVA|||DBP||0.38|-3.98|0.105
72345229|NCT03100058|144213399|OTHER|Dose finding study|Mean Difference (Net)|0.3||||0.82|TWO_SIDED|95.0|-2.36|2.98|||ANCOVA|||DBP||2.98|-2.36|0.820
72345230|NCT03100058|144213399|OTHER|Dose finding study|Mean Difference (Net)|-1.9||||0.157|TWO_SIDED|95.0|-4.58|0.74|||ANCOVA|||DBP||0.74|-4.58|0.157
72345231|NCT03100058|144213399|OTHER|Dose finding study|Mean Difference (Net)|-0.2||||0.859|TWO_SIDED|95.0|-2.99|2.49|||ANCOVA|||DBP||2.49|-2.99|0.859
72345232|NCT03100058|144213399|OTHER|Dose finding study|Mean Difference (Net)|-2.2||||0.054|TWO_SIDED|95.0|-4.41|0.04|||ANCOVA|||DBP||0.04|-4.41|0.054
72345233|NCT03100058|144213401|OTHER|Dose finding study|Median Difference (Net)|-0.6||||0.355|TWO_SIDED|95.0|-1.84|0.66|||ANCOVA|||||0.66|-1.84|0.355
72345234|NCT03100058|144213401|OTHER|Dose finding study|Mean Difference (Net)|-0.6||||0.373|TWO_SIDED|95.0|-1.83|0.69|||ANCOVA|||||0.69|-1.83|0.373
72345235|NCT03100058|144213401|OTHER|Dose finding study|Mean Difference (Net)|-2.8|||<|0.001|TWO_SIDED|95.0|-4.36|-1.24|||ANCOVA|||||-1.24|-4.36|<0.001
72345236|NCT03100058|144213407|OTHER|Dose finding study|Mean Difference (Net)|1.07||||0.632|TWO_SIDED|95.0|0.81|1.42|||ANCOVA|||||1.42|0.81|0.632
72345237|NCT03100058|144213407|OTHER|Dose finding study|Mean Difference (Net)|1.15||||0.352|TWO_SIDED|95.0|0.86|1.55|||ANCOVA|||||1.55|0.86|0.352
72345238|NCT03100058|144213407|OTHER|Dose finding study|Mean Difference (Net)|1.41||||0.027|TWO_SIDED|95.0|1.04|1.92|||ANCOVA|||||1.92|1.04|0.027
72345239|NCT03100058|144213407|OTHER|Dose finding study|Mean Difference (Net)|1.07||||0.587|TWO_SIDED|95.0|0.85|1.35|||ANCOVA|||||1.35|0.85|0.587
72345240|NCT03100058|144213407|OTHER|Dose finding study|Mean Difference (Net)|1.1||||0.508|TWO_SIDED|95.0|0.82|1.47|||ANCOVA|||||1.47|0.82|0.508
72345241|NCT03100058|144213407|OTHER|Dose finding study|Mean Difference (Net)|1.01||||0.945|TWO_SIDED|95.0|0.76|1.34|||ANCOVA|||||1.34|0.76|0.945
72345242|NCT03100058|144213407|OTHER|Dose finding study|Mean Difference (Net)|1.08||||0.602|TWO_SIDED|95.0|0.81|1.45|||ANCOVA|||||1.45|0.81|0.602
72345243|NCT03100058|144213407|OTHER|Dose finding study|Mean Difference (Net)|1.06||||0.612|TWO_SIDED|95.0|0.84|1.35|||ANCOVA|||||1.35|0.84|0.612
72345244|NCT03100058|144213407|OTHER|Dose finding study|Median Difference (Net)|0.89||||0.382|TWO_SIDED|95.0|0.68|1.16|||ANCOVA|||||1.16|0.68|0.382
72345245|NCT03100058|144213407|OTHER|Dose finding study|Median Difference (Net)|0.87||||0.31|TWO_SIDED|95.0|0.67|1.14|||ANCOVA|||||1.14|0.67|0.310
72345246|NCT03100058|144213407|OTHER|Dose finding study|Mean Difference (Net)|0.9||||0.525|TWO_SIDED|95.0|0.65|1.25|||ANCOVA|||||1.25|0.65|0.525
72345247|NCT03100058|144213408|OTHER|Dose finding study|Mean Difference (Net)|-7.9||||0.254|TWO_SIDED|95.0|-21.37|5.65|||ANCOVA|||Triglycerides (TG)||5.65|-21.37|0.254
72345248|NCT03100058|144213408|OTHER|Dose finding study|Mean Difference (Net)|-2.7||||0.716|TWO_SIDED|95.0|-17.44|11.99|||ANCOVA|||Triglycerides (TG)||11.99|-17.44|0.716
72345249|NCT03100058|144213408|OTHER|Dose finding study|Mean Difference (Net)|-15.6||||0.038|TWO_SIDED|95.0|-30.3|-0.86|||ANCOVA|||Triglycerides (TG)||-0.86|-30.30|0.038
72345250|NCT03100058|144213408|OTHER|Dose finding study|Mean Difference (Net)|-7.0||||0.213|TWO_SIDED|95.0|-18.15|4.06|||ANCOVA|||Triglycerides (TG)||4.06|-18.15|0.213
72345251|NCT03100058|144213408|OTHER|Dose finding study|Mean Difference (Net)|-1.7||||0.806|TWO_SIDED|95.0|-15.38|11.96|||ANCOVA|||Triglycerides (TG)||11.96|-15.38|0.806
72345252|NCT03100058|144213408|OTHER|Dose finding study|Mean Difference (Net)|-2.3||||0.739|TWO_SIDED|95.0|-15.8|11.21|||ANCOVA|||Triglycerides (TG)||11.21|-15.80|0.739
72345253|NCT03100058|144213408|OTHER|Dose finding study|Mean Difference (Net)|1.4||||0.837|TWO_SIDED|95.0|-12.36|15.26|||ANCOVA|||Triglycerides (TG)||15.26|-12.36|0.837
72345254|NCT03100058|144213408|OTHER||Mean Difference (Net)|-11.4||||0.049|TWO_SIDED|95.0|-22.71|-0.07|||ANCOVA|||Triglycerides (TG)||-0.07|-22.71|0.049
72345255|NCT03100058|144213408|OTHER|Dose finding study|Median Difference (Net)|1.3||||0.764|TWO_SIDED|95.0|-7.22|9.82|||ANCOVA|||Total Cholesterol (TC)||9.82|-7.22|0.764
72428857|NCT03257995|144368740|OTHER||Mean Difference (Final Values)|5.1|||<|0.001|TWO_SIDED|95.0|2.9|7.2|||ANOVA|||at 23 hours 15 min||7.2|2.9|<0.001
72345256|NCT03100058|144213408|OTHER|Dose finding study|Mean Difference (Net)|2.6||||0.571|TWO_SIDED|95.0|-6.43|11.63|||ANCOVA|||Total Cholesterol (TC)||11.63|-6.43|0.571
72345257|NCT03100058|144213408|OTHER|Dose finding study|Mean Difference (Net)|0.1||||0.987|TWO_SIDED|95.0|-9.3|9.46|||ANCOVA|||Total Cholesterol (TC)||9.46|-9.30|0.987
72345258|NCT03100058|144213408|OTHER|Dose finding study|Mean Difference (Net)|9.9||||0.006|TWO_SIDED|95.0|2.85|16.87|||ANCOVA|||Total Cholesterol (TC)||16.87|2.85|0.006
72345259|NCT03100058|144213408|OTHER|Dose finding study|Mean Difference (Net)|-3.3||||0.463|TWO_SIDED|95.0|-12.03|5.48|||ANCOVA|||Total Cholesterol (TC)||5.48|-12.03|0.463
72345260|NCT03100058|144213408|OTHER|Dose finding study|Mean Difference (Net)|0.4||||0.925|TWO_SIDED|95.0|-8.18|9.01|||ANOVA|||Total Cholesterol (TC)||9.01|-8.18|0.925
72345261|NCT03100058|144213408|OTHER|Dose finding study|Mean Difference (Net)|1.7||||0.711|TWO_SIDED|95.0|-7.19|10.53|||ANCOVA|||Total Cholesterol (TC)||10.53|-7.19|0.711
72345262|NCT03100058|144213408|OTHER|Dose finding study|Mean Difference (Net)|4.1||||0.265|TWO_SIDED|95.0|-3.1|11.26|||ANCOVA|||Total Cholesterol (TC)||11.26|-3.10|0.265
72345263|NCT03100058|144213408|OTHER|Dose finding study|Median Difference (Net)|0.0||||0.995|TWO_SIDED|95.0|-7.31|7.36|||ANCOVA|||HDL Cholesterol||7.36|-7.31|0.995
72345264|NCT03100058|144213408|OTHER|Dose finding study|Mean Difference (Net)|4.1||||0.288|TWO_SIDED|95.0|-3.52|11.81|||ANCOVA|||HDL Cholesterol||11.81|-3.52|0.288
72345265|NCT03100058|144213408|OTHER|Dose finding study|Mean Difference (Net)|4.5||||0.269|TWO_SIDED|95.0|-3.5|12.5|||ANCOVA|||HDL Cholesterol||12.50|-3.50|0.269
72345266|NCT03100058|144213408|OTHER|Dose finding study|Median Difference (Net)|7.3||||0.018|TWO_SIDED|95.0|1.23|13.27|||ANCOVA|||HDL Cholesterol||13.27|1.23|0.018
72345267|NCT03100058|144213408|OTHER|Dose finding study|Median Difference (Net)|2.2||||0.565|TWO_SIDED|95.0|-5.32|9.73|||ANCOVA|||HDL Cholesterol||9.73|-5.32|0.565
72345268|NCT03100058|144213408|OTHER|Dose finding study|Mean Difference (Net)|1.7||||0.649|TWO_SIDED|95.0|-5.67|9.09|||ANCOVA|||HDL Cholesterol||9.09|-5.67|0.649
72345269|NCT03100058|144213408|OTHER|Dose finding study|Mean Difference (Net)|0.7||||0.847|TWO_SIDED|95.0|-6.87|8.36|||ANCOVA|||HDL Cholesterol||8.36|-6.87|0.847
72345270|NCT03100058|144213408|OTHER|Dose finding study|Mean Difference (Net)|7.3||||0.02|TWO_SIDED|95.0|1.14|13.43|||ANCOVA|||HDL Cholesterol||13.43|1.14|0.020
72345271|NCT03100058|144213408|OTHER|Dose finding study|Mean Difference (Net)|-3.8||||0.579|TWO_SIDED|95.0|-17.09|9.57|||ANCOVA|||LDL Cholesterol||9.57|-17.09|0.579
72345272|NCT03100058|144213408|OTHER||Mean Difference (Net)|5.0||||0.487|TWO_SIDED|95.0|-9.08|19.02|||ANCOVA|||LDL Cholesterol||19.02|-9.08|0.487
72345273|NCT03100058|144213408|OTHER|Dose finding study|Mean Difference (Net)|-4.3||||0.561|TWO_SIDED|95.0|-18.96|10.3|||ANCOVA|||LDL Cholesterol||10.30|-18.96|0.561
72345274|NCT03100058|144213408|OTHER||Mean Difference (Net)|9.3||||0.097|TWO_SIDED|95.0|-1.68|20.25|||ANCOVA|||LDL Cholesterol||20.25|-1.68|0.097
72345275|NCT03100058|144213408|OTHER|Dose finding study|Mean Difference (Net)|-8.4||||0.227|TWO_SIDED|95.0|-22.1|5.26|||ANCOVA|||LDL Cholesterol||5.26|-22.10|0.227
72345276|NCT03100058|144213408|OTHER|Dose finding study|Mean Difference (Net)|-3.8||||0.58|TWO_SIDED|95.0|-17.22|9.64|||ANCOVA|||LDL Cholesterol||9.64|-17.22|0.580
72345277|NCT03100058|144213408|OTHER|Dose finding study|Mean Difference (Net)|-4.8||||0.494|TWO_SIDED|95.0|-18.67|9.03|||ANCOVA|||LDL Cholesterol||9.03|-18.67|0.494
72345278|NCT03100058|144213408|OTHER|Dose finding study|Mean Difference (Net)|-1.6||||0.782|TWO_SIDED|95.0|-12.81|9.65|||ANCOVA|||LDL Cholesterol||9.65|-12.81|0.782
72345279|NCT03100058|144213408|OTHER|Dose finding study|Mean Difference (Net)|1.9||||0.816|TWO_SIDED|95.0|-13.82|17.54|||ANCOVA|||Triglycerides (TG)||17.54|-13.82|0.816
72345280|NCT03100058|144213408|OTHER|Dose finding study|Mean Difference (Net)|8.02||||0.341|TWO_SIDED|95.0|-8.13|23.42|||ANCOVA|||Triglycerides (TG)||23.42|-8.13|0.341
72345281|NCT03100058|144213408|OTHER|Dose finding study|Median Difference (Net)|9.99||||0.566|TWO_SIDED|95.0|-25.39|13.91|||ANCOVA|||Triglycerides (TG)||13.91|-25.39|0.566
72345282|NCT03100058|144213408|OTHER|Dose finding study|Mean Difference (Net)|2.98||||0.405|TWO_SIDED|95.0|-3.38|8.36|||ANCOVA|||Total Cholesterol (TC)||8.36|-3.38|0.405
72428858|NCT03257995|144368740|OTHER||Mean Difference (Final Values)|5.9|||<|0.001|TWO_SIDED|95.0|3.7|8.0|||ANOVA|||at 23 hours 45 min||8.0|3.7|<0.001
72345283|NCT03100058|144213408|OTHER|Dose finding study|Median Difference (Net)|2.0||||0.511|TWO_SIDED|95.0|-3.92|7.87|||ANCOVA|||Total Cholesterol (TC)||7.87|-3.92|0.511
72345284|NCT03100058|144213408|OTHER|Dose finding study|Mean Difference (Net)|2.5||||0.506|TWO_SIDED|95.0|-4.83|9.79|||ANCOVA|||Total Cholesterol (TC)||9.79|-4.83|0.506
72345285|NCT03100058|144213408|OTHER|Dose finding study|Median Difference (Net)|3.3||||0.392|TWO_SIDED|95.0|-4.2|10.7|||ANCOVA|||HDL Cholesterol||10.70|-4.20|0.392
72345286|NCT03100058|144213408|OTHER|Dose finding study|Mean Difference (Net)|3.0||||0.426|TWO_SIDED|95.0|-4.45|10.53|||ANOVA|||HDL Cholesterol||10.53|-4.45|0.426
72345287|NCT03100058|144213408|OTHER|Dose finding study|Mean Difference (Net)|8.5||||0.071|TWO_SIDED|95.0|-0.72|17.8|||ANCOVA|||HDL Cholesterol||17.80|-0.72|0.071
72345288|NCT03100058|144213408|OTHER|Dose finding study|Mean Difference (Net)|2.9||||0.498|TWO_SIDED|95.0|-5.56|11.42|||ANCOVA|||LDL Cholesterol||11.42|-5.56|0.498
72345289|NCT03100058|144213408|OTHER|Dose finding study|Median Difference (Net)|2.4||||0.586|TWO_SIDED|95.0|-6.17|10.9|||ANCOVA|||LDL Cholesterol||10.90|-6.17|0.586
72345290|NCT03100058|144213408|OTHER|Dose finding study|Mean Difference (Net)|2.1||||0.696|TWO_SIDED|95.0|-8.47|12.67|||ANCOVA|||LDL Cholesterol||12.67|-8.47|0.696
72345291|NCT00774800|144213419|SUPERIORITY_OR_OTHER||Geometric Least Squares Means Ratio|1.54||||0.0011||||||Statistical testing was considered exploratory, with no adjustment for inflation of Type 1 error due to multiplicity of testing.|ANOVA|||Due to the exploratory nature of this study, the sample size is not based on a formal calculation.||||0.0011
72345292|NCT00774800|144213419|SUPERIORITY_OR_OTHER||Geometric Least Squares Means Ratio|3.06|||<|0.0001||||||Statistical testing was considered exploratory, with no adjustment for inflation of Type 1 error due to multiplicity of testing.|ANOVA|||Due to the exploratory nature of this study, the sample size is not based on a formal calculation.||||<0.0001
72345293|NCT00774800|144213420|SUPERIORITY_OR_OTHER||Geometric Least Squares Means Ratio|1.35||||0.0057||||||Statistical testing was considered exploratory, with no adjustment for inflation of Type 1 error due to multiplicity of testing.|ANOVA|||Due to the exploratory nature of this study, the sample size is not based on a formal calculation.||||0.0057
72345294|NCT00774800|144213420|SUPERIORITY_OR_OTHER||Geometric Least Squares Means Ratio|1.66|||<|0.0001||||||Statistical testing was considered exploratory, with no adjustment for inflation of Type 1 error due to multiplicity of testing.|ANOVA|||Due to the exploratory nature of this study, the sample size is not based on a formal calculation.||||<0.0001
72428859|NCT03257995|144368741|OTHER||Mean Difference (Final Values)|0.1866|||<|0.001|TWO_SIDED|95.0|0.1121|0.2611|||ANOVA|||5 min||0.2611|0.1121|<0.001
72345295|NCT00774800|144213421|SUPERIORITY_OR_OTHER||Least Squares Means Difference|-18.33|||<|0.0001||||||Statistical testing was considered exploratory, with no adjustment for inflation of Type 1 error due to multiplicity of testing.|ANOVA|||Due to the exploratory nature of this study, the sample size is not based on a formal calculation.||||<0.0001
72345296|NCT00774800|144213421|SUPERIORITY_OR_OTHER||Least Squares Means Difference|-62.46||||0.0018|||||||ANOVA|Statistical testing was considered exploratory, with no adjustment for inflation of Type 1 error due to multiplicity of testing.||Due to the exploratory nature of this study, the sample size is not based on a formal calculation.||||0.0018
72345297|NCT01059994|144213423|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED||||||t-test, 2 sided|||||||0.02
72345298|NCT01059994|144213424|SUPERIORITY_OR_OTHER|||||||0.004|TWO_SIDED||||||t-test, 2 sided|||||||0.004
72345299|NCT00479856|144213432|SUPERIORITY_OR_OTHER||percentage of participants|33.3||||||95.0|7.5|70.1||||||||70.1|7.5|
72345300|NCT04569357|144213478|SUPERIORITY|||||||0.0199|||||||Fisher Exact|||Test for comparison percentage of patients with reduction ≥ 25%.||||0.0199
72345301|NCT04569357|144213479|SUPERIORITY|||||||0.0096|||||||Wilcoxon (Mann-Whitney)|||Mean changes of ADHD-RS-V scores after 8 weeks of treatment were compared.||||0.0096
72345302|NCT04569357|144213480|SUPERIORITY|||||||0.0063|||||||Wilcoxon (Mann-Whitney)|||Mean changes of ADHD-RS-V scores (attention deficit subscale) after 8 weeks of treatment were compared.||||0.0063
72345303|NCT04569357|144213481|SUPERIORITY|||||||0.0525|||||||Wilcoxon (Mann-Whitney)|||Mean changes of ADHD-RS-V scores (hyperactivity/impulsivity subscale) after 8 weeks of treatment were compared.||||0.0525
72345304|NCT04569357|144213482|SUPERIORITY|||||||0.0024|||||||Wilcoxon (Mann-Whitney)|||Therapeutic effect analysis.||||0.0024
72345305|NCT04569357|144213482|SUPERIORITY|||||||0.1722|||||||Wilcoxon (Mann-Whitney)|||Side effects analysis.||||0.1722
72345306|NCT04569357|144213482|SUPERIORITY|||||||0.0012|||||||Wilcoxon (Mann-Whitney)|||Efficacy index analysis.||||0.0012
72345307|NCT04569357|144213483|SUPERIORITY|||||||0.13||||||"The p-value associated with treatment\*visit interaction of changes from baseline visit 1 to visit 2 and 3 endpoint between Prospekta and Placebo treatment groups. Model includes treatment, visit and treatment\*visit interaction."|ANOVA|||||||0.13
72428860|NCT03257995|144368741|OTHER||Mean Difference (Final Values)|0.2249|||<|0.001|TWO_SIDED|95.0|0.1506|0.2992|||ANOVA|||15 min||0.2992|0.1506|<0.001
72345308|NCT04569357|144213484|SUPERIORITY|||||||0.81||||||"The p-value associated with treatment\*visit interaction of changes from baseline visit 1 to visit 2 and 3 endpoint between Prospekta and Placebo treatment groups. Model includes treatment, visit and treatment\*visit interaction."|ANOVA|||This analysis applies to Systolic pressure data.||||0.81
72345309|NCT04569357|144213484|SUPERIORITY|||||||0.22||||||"The p-value associated with treatment\*visit interaction of changes from baseline visit 1 to visit 2 and 3 endpoint between Prospekta and Placebo treatment groups. Model includes treatment, visit and treatment\*visit interaction."|ANOVA|||This analysis applies to Diastolic pressure data.||||0.22
72345310|NCT04569357|144213485|SUPERIORITY|||||||0.13||||||"The p-value associated with treatment\*visit interaction of changes from baseline visit 1 to visit 2 and 3 endpoint between Prospekta and Placebo treatment groups. Model includes treatment, visit and treatment\*visit interaction."|ANOVA|||||||0.13
72345311|NCT04569357|144213486|SUPERIORITY|||||||0.2|||||||Fisher Exact|||||||0.2
72345312|NCT04569357|144213487|SUPERIORITY|||||||0.62|||||||Fisher Exact|||||||0.62
72345313|NCT04569357|144213488|SUPERIORITY|||||||0.5|||||||Fisher Exact|||||||0.5
72345314|NCT04569357|144213489|SUPERIORITY|||||||0.0254|||||||Fisher Exact|||||||0.0254
72345315|NCT01124955|144213493|SUPERIORITY_OR_OTHER||||||,|0|||||||ANOVA|||||||0,05
72428861|NCT03257995|144368741|OTHER||Mean Difference (Final Values)|0.2404|||<|0.001|TWO_SIDED|95.0|0.1661|0.3148|||ANOVA|||30 min||0.3148|0.1661|<0.001
72428862|NCT03257995|144368741|OTHER||Mean Difference (Final Values)|0.2074|||<|0.001|TWO_SIDED|95.0|0.133|0.2817|||ANOVA|||1 hour||0.2817|0.1330|<0.001
72345316|NCT00148941|144213532|EQUIVALENCE|Lot-to-lot consistency in terms of immunogenicity would be demonstrated if the lower and upper limits of the 95% confidence intervals (CIs) for the ratios of GMCs for each antigen (D, T, PT, FHA, PRN, and Poliovirus types 1, 2, and 3) and between each pair of the three lots of SB213503 vaccine were within the pre-defined clinical limits of \[0.67; 1.5\].|GMC ratio|0.97|||||TWO_SIDED|95.0|0.871|1.08|||ANCOVA|Ancova model: adjustment for baseline concentration - pooled variance with more than 2 groups.||The lot-to-lot consistency of three manufacturing lots of SB213503 vaccine in terms of diphtheria toxoid (D) in a subset of subjects one month after vaccination when co-administered with M-M-R II.||1.080|0.871|
72345317|NCT00148941|144213532|EQUIVALENCE|Lot-to-lot consistency in terms of immunogenicity would be demonstrated if the lower and upper limits of the 95% CIs for the ratios of GMCs for each antigen (D, T, PT, FHA, PRN, and Poliovirus types 1, 2, and 3) and between each pair of the three lots of SB213503 vaccine were within the pre-defined clinical limits of \[0.67; 1.5\].|GMC ratio|0.961|||||TWO_SIDED|95.0|0.863|1.07|||ANCOVA|Ancova model: adjustment for baseline concentration - pooled variance with more than 2 groups.||The lot-to-lot consistency of three manufacturing lots of SB213503 vaccine in terms of diphtheria toxoid (D) in a subset of subjects one month after vaccination when co-administered with M-M-R II.||1.070|0.863|
72345318|NCT00148941|144213532|EQUIVALENCE|Lot-to-lot consistency in terms of immunogenicity would be demonstrated if the lower and upper limits of the 95% CIs for the ratios of GMCs for each antigen (D, T, PT, FHA, PRN, and Poliovirus types 1, 2, and 3) and between each pair of the three lots of SB213503 vaccine were within the pre-defined clinical limits of \[0.67; 1.5\].|GMC ratio|0.991|||||TWO_SIDED|95.0|0.89|1.103|||ANCOVA|Ancova model: adjustment for baseline concentration - pooled variance with more than 2 groups.||The lot-to-lot consistency of three manufacturing lots of SB213503 vaccine in terms of diphtheria toxoid (D) in a subset of subjects one month after vaccination when co-administered with M-M-R II.||1.103|0.890|
72345319|NCT00148941|144213532|EQUIVALENCE|Lot-to-lot consistency in terms of immunogenicity would be demonstrated if the lower and upper limits of the 95% CIs for the ratios of GMCs for each antigen (D, T, PT, FHA, PRN, and Poliovirus types 1, 2, and 3) and between each pair of the three lots of SB213503 vaccine were within the pre-defined clinical limits of \[0.67; 1.5\].|GMC ratio|0.975|||||TWO_SIDED|95.0|0.866|1.097|||ANCOVA|Ancova model: adjustment for baseline concentration - pooled variance with more than 2 groups.||The lot-to-lot consistency of three manufacturing lots of SB213503 vaccine in terms of tetanus toxoid (T) in a subset of subjects one month after vaccination when co-administered with M-M-R II.||1.097|0.866|
72345320|NCT00148941|144213532|EQUIVALENCE|Lot-to-lot consistency in terms of immunogenicity would be demonstrated if the lower and upper limits of the 95% CIs for the ratios of GMCs for each antigen (D, T, PT, FHA, PRN, and Poliovirus types 1, 2, and 3) and between each pair of the three lots of SB213503 vaccine were within the pre-defined clinical limits of \[0.67; 1.5\].|GMC ratio|0.878|||||TWO_SIDED|95.0|0.78|0.988|||ANCOVA|Ancova model: adjustment for baseline concentration - pooled variance with more than 2 groups.||The lot-to-lot consistency of three manufacturing lots of SB213503 vaccine in terms of tetanus toxoid (T) in a subset of subjects one month after vaccination when co-administered with M-M-R II.||0.988|0.780|
72345321|NCT00148941|144213532|EQUIVALENCE|Lot-to-lot consistency in terms of immunogenicity would be demonstrated if the lower and upper limits of the 95% CIs for the ratios of GMCs for each antigen (D, T, PT, FHA, PRN, and Poliovirus types 1, 2, and 3) and between each pair of the three lots of SB213503 vaccine were within the pre-defined clinical limits of \[0.67; 1.5\].|GMC ratio|0.901|||||TWO_SIDED|95.0|0.8|1.014|||ANCOVA|Ancova model: adjustment for baseline concentration - pooled variance with more than 2 groups.||The lot-to-lot consistency of three manufacturing lots of SB213503 vaccine in terms of tetanus toxoid (T) in a subset of subjects one month after vaccination when co-administered with M-M-R II.||1.014|0.800|
72345322|NCT00148941|144213533|EQUIVALENCE|Lot-to-lot consistency in terms of immunogenicity would be demonstrated if the lower and upper limits of the 95% CIs for the ratios of GMCs for each antigen (D, T, PT, FHA, PRN, and Poliovirus types 1, 2, and 3) and between each pair of the three lots of SB213503 vaccine were within the pre-defined clinical limits of \[0.67; 1.5\].|GMC ratio|0.938|||||TWO_SIDED|95.0|0.828|1.063|||ANCOVA|Ancova model: adjustment for baseline concentration - pooled variance with more than 2 groups.||The lot-to-lot consistency of three manufacturing lots of SB213503 vaccine in terms of pertussis toxoid (PT) in a subset of subjects one month after vaccination when co-administered with M-M-R II.||1.063|0.828|
72345323|NCT00148941|144213533|EQUIVALENCE|Lot-to-lot consistency in terms of immunogenicity would be demonstrated if the lower and upper limits of the 95% CIs for the ratios of GMCs for each antigen (D, T, PT, FHA, PRN, and Poliovirus types 1, 2, and 3) and between each pair of the three lots of SB213503 vaccine were within the pre-defined clinical limits of \[0.67; 1.5\].|GMC ratio|0.963|||||TWO_SIDED|95.0|0.85|1.091|||ANCOVA|Ancova model: adjustment for baseline concentration - pooled variance with more than 2 groups.||The lot-to-lot consistency of three manufacturing lots of SB213503 vaccine in terms of pertussis toxoid (PT) in a subset of subjects one month after vaccination when co-administered with M-M-R II.||1.091|0.850|
72345324|NCT00148941|144213533|EQUIVALENCE|Lot-to-lot consistency in terms of immunogenicity would be demonstrated if the lower and upper limits of the 95% CIs for the ratios of GMCs for each antigen (D, T, PT, FHA, PRN, and Poliovirus types 1, 2, and 3) and between each pair of the three lots of SB213503 vaccine were within the pre-defined clinical limits of \[0.67; 1.5\].|GMC ratio|1.026|||||TWO_SIDED|95.0|0.906|1.162|||ANCOVA|Ancova model: adjustment for baseline concentration - pooled variance with more than 2 groups.||The lot-to-lot consistency of three manufacturing lots of SB213503 vaccine in terms of pertussis toxoid (PT) in a subset of subjects one month after vaccination when co-administered with M-M-R II.||1.162|0.906|
72428863|NCT03257995|144368741|OTHER||Mean Difference (Final Values)|0.1802|||<|0.001|TWO_SIDED|95.0|0.1059|0.2545|||ANOVA|||2 hours||0.2545|0.1059|<0.001
72428864|NCT03257995|144368741|OTHER||Mean Difference (Final Values)|0.1621|||<|0.001|TWO_SIDED|95.0|0.0876|0.2366|||ANOVA|||4 hours||0.2366|0.0876|<0.001
72428865|NCT03257995|144368741|OTHER||Mean Difference (Final Values)|0.199|||<|0.001|TWO_SIDED|95.0|0.1239|0.2742|||ANOVA|||8 hours||0.2742|0.1239|<0.001
72428866|NCT03257995|144368741|OTHER||Mean Difference (Final Values)|0.1747|||<|0.001|TWO_SIDED|95.0|0.0994|0.2501|||ANOVA|||12 hours||0.2501|0.0994|<0.001
72428867|NCT03257995|144368741|OTHER||Mean Difference (Final Values)|0.1856|||<|0.001|TWO_SIDED|95.0|0.1081|0.2631|||ANOVA|||23 hours 15 min||0.2631|0.1081|<0.001
72428868|NCT03257995|144368741|OTHER||Mean Difference (Final Values)|0.1484|||<|0.001|TWO_SIDED|95.0|0.0709|0.2259|||ANOVA|||23 hours 45 min||0.2259|0.0709|<0.001
72428869|NCT03257995|144368741|OTHER||Mean Difference (Final Values)|0.213|||<|0.001|TWO_SIDED|95.0|0.1386|0.2873|||ANOVA|||5 min||0.2873|0.1386|<0.001
72345325|NCT00148941|144213533|EQUIVALENCE|Lot-to-lot consistency in terms of immunogenicity would be demonstrated if the lower and upper limits of the 95% CIs for the ratios of GMCs for each antigen (D, T, PT, FHA, PRN, and Poliovirus types 1, 2, and 3) and between each pair of the three lots of SB213503 vaccine were within the pre-defined clinical limits of \[0.67; 1.5\].|GMC ratio|0.874|||||TWO_SIDED|95.0|0.783|0.976|||ANCOVA|Ancova model: adjustment for baseline concentration - pooled variance with more than 2 groups.||The lot-to-lot consistency of three manufacturing lots of SB213503 vaccine in terms of filamentous haemagglutinin (FHA) in a subset of subjects one month after vaccination when co-administered with M-M-R II.||0.976|0.783|
72345326|NCT00148941|144213533|EQUIVALENCE|Lot-to-lot consistency in terms of immunogenicity would be demonstrated if the lower and upper limits of the 95% CIs for the ratios of GMCs for each antigen (D, T, PT, FHA, PRN, and Poliovirus types 1, 2, and 3) and between each pair of the three lots of SB213503 vaccine were within the pre-defined clinical limits of \[0.67; 1.5\].|GMC ratio|0.947|||||TWO_SIDED|95.0|0.849|1.057|||ANCOVA|Ancova model: adjustment for baseline concentration - pooled variance with more than 2 groups.||The lot-to-lot consistency of three manufacturing lots of SB213503 vaccine in terms of filamentous haemagglutinin (FHA) in a subset of subjects one month after vaccination when co-administered with M-M-R II.||1.057|0.849|
72345327|NCT00148941|144213533|EQUIVALENCE|Lot-to-lot consistency in terms of immunogenicity would be demonstrated if the lower and upper limits of the 95% CIs for the ratios of GMCs for each antigen (D, T, PT, FHA, PRN, and Poliovirus types 1, 2, and 3) and between each pair of the three lots of SB213503 vaccine were within the pre-defined clinical limits of \[0.67; 1.5\].|GMC ratio|1.084|||||TWO_SIDED|95.0|0.971|1.209|||ANCOVA|Ancova model: adjustment for baseline concentration - pooled variance with more than 2 groups.||The lot-to-lot consistency of three manufacturing lots of SB213503 vaccine in terms of filamentous haemagglutinin (FHA) in a subset of subjects one month after vaccination when co-administered with M-M-R II.||1.209|0.971|
72345328|NCT00148941|144213533|EQUIVALENCE|Lot-to-lot consistency in terms of immunogenicity would be demonstrated if the lower and upper limits of the 95% CIs for the ratios of GMCs for each antigen (D, T, PT, FHA, PRN, and Poliovirus types 1, 2, and 3) and between each pair of the three lots of SB213503 vaccine were within the pre-defined clinical limits of \[0.67; 1.5\].|GMC ratio|0.998|||||TWO_SIDED|95.0|0.867|1.148|||ANCOVA|Ancova model: adjustment for baseline concentration - pooled variance with more than 2 groups.||The lot-to-lot consistency of three manufacturing lots of SB213503 vaccine in terms of pertactin (PRN) in a subset of subjects one month after vaccination when co-administered with M-M-R II.||1.148|0.867|
72345329|NCT00148941|144213533|EQUIVALENCE|Lot-to-lot consistency in terms of immunogenicity would be demonstrated if the lower and upper limits of the 95% CIs for the ratios of GMCs for each antigen (D, T, PT, FHA, PRN, and Poliovirus types 1, 2, and 3) and between each pair of the three lots of SB213503 vaccine were within the pre-defined clinical limits of \[0.67; 1.5\].|GMC ratio|1.043|||||TWO_SIDED|95.0|0.907|1.2|||ANCOVA|Ancova model: adjustment for baseline concentration - pooled variance with more than 2 groups.||The lot-to-lot consistency of three manufacturing lots of SB213503 vaccine in terms of pertactin (PRN) in a subset of subjects one month after vaccination when co-administered with M-M-R II.||1.200|0.907|
72345330|NCT00148941|144213533|EQUIVALENCE|Lot-to-lot consistency in terms of immunogenicity would be demonstrated if the lower and upper limits of the 95% CIs for the ratios of GMCs for each antigen (D, T, PT, FHA, PRN, and Poliovirus types 1, 2, and 3) and between each pair of the three lots of SB213503 vaccine were within the pre-defined clinical limits of \[0.67; 1.5\].|GMC ratio|1.045|||||TWO_SIDED|95.0|0.909|1.202|||ANCOVA|Ancova model: adjustment for baseline concentration - pooled variance with more than 2 groups.||The lot-to-lot consistency of three manufacturing lots of SB213503 vaccine in terms of pertactin (PRN) in a subset of subjects one month after vaccination when co-administered with M-M-R II.||1.202|0.909|
72345331|NCT00148941|144213534|EQUIVALENCE|Lot-to-lot consistency in terms of immunogenicity would be demonstrated if the lower and upper limits of the 95% CIs for the ratios of GMTs for each antigen (D, T, PT, FHA, PRN, and Poliovirus types 1, 2, and 3) and between each pair of the three lots of SB213503 vaccine were within the pre-defined clinical limits of \[0.67; 1.5\].|GMT ratio|0.994|||||TWO_SIDED|95.0|0.836|1.181|||ANCOVA|Ancova model: adjustment for baseline titer - pooled variance with more than 2 groups.||The lot-to-lot consistency of three manufacturing lots of SB213503 vaccine in terms of poliovirus type 1 geometric mean titers (GMTs) in a subset of subjects one month after vaccination when co-administered with M-M-R II.||1.181|0.836|
72345332|NCT00148941|144213534|EQUIVALENCE|Lot-to-lot consistency in terms of immunogenicity would be demonstrated if the lower and upper limits of the 95% CIs for the ratios of GMTs for each antigen (D, T, PT, FHA, PRN, and Poliovirus types 1, 2, and 3) and between each pair of the three lots of SB213503 vaccine were within the pre-defined clinical limits of \[0.67; 1.5\].|GMT ratio|0.987|||||TWO_SIDED|95.0|0.831|1.172|||ANCOVA|Ancova model: adjustment for baseline titer - pooled variance with more than 2 groups.||The lot-to-lot consistency of three manufacturing lots of SB213503 vaccine in terms of poliovirus type 1 geometric mean titers (GMTs) in a subset of subjects one month after vaccination when co-administered with M-M-R II.||1.172|0.831|
72345333|NCT00148941|144213534|EQUIVALENCE|Lot-to-lot consistency in terms of immunogenicity would be demonstrated if the lower and upper limits of the 95% CIs for the ratios of GMTs for each antigen (D, T, PT, FHA, PRN, and Poliovirus types 1, 2, and 3) and between each pair of the three lots of SB213503 vaccine were within the pre-defined clinical limits of \[0.67; 1.5\].|GMT ratio|0.993|||||TWO_SIDED|95.0|0.836|1.18|||ANCOVA|Ancova model: adjustment for baseline titer - pooled variance with more than 2 groups.||The lot-to-lot consistency of three manufacturing lots of SB213503 vaccine in terms of poliovirus type 1 geometric mean titers (GMTs) in a subset of subjects one month after vaccination when co-administered with M-M-R II.||1.180|0.836|
72428870|NCT03257995|144368741|OTHER||Mean Difference (Final Values)|0.2173|||<|0.001|TWO_SIDED|95.0|0.1426|0.292|||ANOVA|||15 min||0.2920|0.1426|<0.001
72428871|NCT03257995|144368741|OTHER||Mean Difference (Final Values)|0.2375|||<|0.001|TWO_SIDED|95.0|0.1632|0.3118|||ANOVA|||30 min||0.3118|0.1632|<0.001
72428872|NCT03257995|144368741|OTHER||Mean Difference (Final Values)|0.2013|||<|0.001|TWO_SIDED|95.0|0.1272|0.2754|||ANOVA|||1 hour||0.2754|0.1272|<0.001
72428873|NCT03257995|144368741|OTHER||Mean Difference (Final Values)|0.2005|||<|0.001|TWO_SIDED|95.0|0.1262|0.2749|||ANOVA|||2 hours||0.2749|0.1262|<0.001
72428874|NCT03257995|144368741|OTHER||Mean Difference (Final Values)|0.1946|||<|0.001|TWO_SIDED|95.0|0.1201|0.2691|||ANOVA|||4 hours||0.2691|0.1201|<0.001
72428875|NCT03257995|144368741|OTHER||Mean Difference (Final Values)|0.1937|||<|0.001|TWO_SIDED|95.0|0.119|0.2684|||ANOVA|||8 hours||0.2684|0.1190|<0.001
72345334|NCT00148941|144213534|EQUIVALENCE|Lot-to-lot consistency in terms of immunogenicity would be demonstrated if the lower and upper limits of the 95% CIs for the ratios of GMTs for each antigen (D, T, PT, FHA, PRN, and Poliovirus types 1, 2, and 3) and between each pair of the three lots of SB213503 vaccine were within the pre-defined clinical limits of \[0.67; 1.5\].|GMT ratio|1.118|||||TWO_SIDED|95.0|0.951|1.314|||ANCOVA|Ancova model: adjustment for baseline titer - pooled variance with more than 2 groups.||The lot-to-lot consistency of three manufacturing lots of SB213503 vaccine in terms of poliovirus type 2 geometric mean titers (GMTs) in a subset of subjects one month after vaccination when co-administered with M-M-R II.||1.314|0.951|
72345335|NCT00148941|144213534|EQUIVALENCE|Lot-to-lot consistency in terms of immunogenicity would be demonstrated if the lower and upper limits of the 95% CIs for the ratios of GMTs for each antigen (D, T, PT, FHA, PRN, and Poliovirus types 1, 2, and 3) and between each pair of the three lots of SB213503 vaccine were within the pre-defined clinical limits of \[0.67; 1.5\].|GMT ratio|1.006|||||TWO_SIDED|95.0|0.856|1.183|||ANCOVA|Ancova model: adjustment for baseline titer - pooled variance with more than 2 groups.||The lot-to-lot consistency of three manufacturing lots of SB213503 vaccine in terms of poliovirus type 2 geometric mean titers (GMTs) in a subset of subjects one month after vaccination when co-administered with M-M-R II.||1.183|0.856|
72345336|NCT00148941|144213534|EQUIVALENCE|Lot-to-lot consistency in terms of immunogenicity would be demonstrated if the lower and upper limits of the 95% CIs for the ratios of GMTs for each antigen (D, T, PT, FHA, PRN, and Poliovirus types 1, 2, and 3) and between each pair of the three lots of SB213503 vaccine were within the pre-defined clinical limits of \[0.67; 1.5\] for Anti-poliovirus type 2.|GMT ratio|0.9|||||TWO_SIDED|95.0|0.765|1.06|||ANCOVA|Ancova model: adjustment for baseline titer - pooled variance with more than 2 groups.||The lot-to-lot consistency of three manufacturing lots of SB213503 vaccine in terms of poliovirus type 2 geometric mean titers (GMTs) in a subset of subjects one month after vaccination when co-administered with M-M-R II.||1.060|0.765|
72345337|NCT00148941|144213534|EQUIVALENCE|Lot-to-lot consistency in terms of immunogenicity would be demonstrated if the lower and upper limits of the 95% CIs for the ratios of GMTs for each antigen (D, T, PT, FHA, PRN, and Poliovirus types 1, 2, and 3) and between each pair of the three lots of SB213503 vaccine were within the pre-defined clinical limits of \[0.67; 1.5\].|GMT ratio|1.112|||||TWO_SIDED|95.0|0.941|1.314|||ANCOVA|Ancova model: adjustment for baseline titer - pooled variance with more than 2 groups.||The lot-to-lot consistency of three manufacturing lots of SB213503 vaccine in terms of poliovirus type 3 geometric mean titers (GMTs) in a subset of subjects one month after vaccination when co-administered with M-M-R II.||1.314|0.941|
72345338|NCT00148941|144213534|EQUIVALENCE|Lot-to-lot consistency in terms of immunogenicity would be demonstrated if the lower and upper limits of the 95% CIs for the ratios of GMTs for each antigen (D, T, PT, FHA, PRN, and Poliovirus types 1, 2, and 3) and between each pair of the three lots of SB213503 vaccine were within the pre-defined clinical limits of \[0.67; 1.5\].|GMT ratio|1.034|||||TWO_SIDED|95.0|0.876|1.22|||ANCOVA|Ancova model: adjustment for baseline titer - pooled variance with more than 2 groups.||The lot-to-lot consistency of three manufacturing lots of SB213503 vaccine in terms of poliovirus type 3 geometric mean titers (GMTs) in a subset of subjects one month after vaccination when co-administered with M-M-R II.||1.220|0.876|
72345339|NCT00148941|144213534|EQUIVALENCE|Lot-to-lot consistency in terms of immunogenicity would be demonstrated if the lower and upper limits of the 95% CIs for the ratios of GMTs for each antigen (D, T, PT, FHA, PRN, and Poliovirus types 1, 2, and 3) and between each pair of the three lots of SB213503 vaccine were within the pre-defined clinical limits of \[0.67; 1.5\].|GMT ratio|0.93|||||TWO_SIDED|95.0|0.787|1.099|||ANCOVA|Ancova model: adjustment for baseline titer - pooled variance with more than 2 groups.||The lot-to-lot consistency of three manufacturing lots of SB213503 vaccine in terms of poliovirus type 3 geometric mean titers (GMTs) in a subset of subjects one month after vaccination when co-administered with M-M-R II.||1.099|0.787|
72345340|NCT00148941|144213534|NON_INFERIORITY|The objectives were achieved if for D, T, PT, FHA and PRN: the upper limit of the two-sided standardized asymptotic 95% CI of the difference in booster response rates was less than or equal to the pre-defined clinical limit of 10% AND for poliovirus types 1, 2 and 3: the upper limit of the two-sided 95% confidence interval (CI) for the GMT ratio was less than or equal to the pre-defined clinical limit of 1.5.|GMT ration|0.792|||||TWO_SIDED|95.0|0.68|0.922|||ANCOVA|ANCOVA model: adjustment for baseline titer - pooled variance||Analysis of the non-inferiority of SB213503 vaccine compared to Infanrix + IPOL administered separately in terms of anti-poliovirus type 1 (measured by the GMT ratio of Infanrix + IPOL + M-M-R Group over SB213503 + M-M-R Group = pooled lot 1, 2 \& 3 groups) in a subset of subjects one month after vaccination when co-administered with M-M-R II.|SB213503 lot 1, SB213503 lot 2, and SB213503 lot 3 Arms/Groups were pooled for statistical analysis.|0.922|0.680|
72345341|NCT00148941|144213534|NON_INFERIORITY|The objectives were achieved if for D, T, PT, FHA and PRN: the upper limit of the two-sided standardized asymptotic 95% CI of the difference in booster response rates was less than or equal to the pre-defined clinical limit of 10% AND for poliovirus types 1, 2 and 3: the upper limit of the two-sided 95% confidence interval (CI) for the GMT ratio was less than or equal to the pre-defined clinical limit of 1.5.|GMT ratio|0.802|||||TWO_SIDED|95.0|0.696|0.925|||ANCOVA|ANCOVA model: adjustment for baseline titer - pooled variance||Analysis of the non-inferiority of SB213503 vaccine compared to Infanrix + IPOL administered separately in terms of anti-poliovirus type 2 (measured by the GMT ratio of Infanrix + IPOL + M-M-R Group over SB213503 + M-M-R Group = pooled lot 1, 2 \& 3 groups) in a subset of subjects one month after vaccination when co-administered with M-M-R II.|SB213503 lot 1, SB213503 lot 2, and SB213503 lot 3 Arms/Groups were pooled for statistical analysis.|0.925|0.696|
72368382|NCT00298558|144246921|SUPERIORITY_OR_OTHER||Effect Size|-0.07||||0.45|TWO_SIDED|99.0|-0.29|0.16|||Mixed Models Analysis|The blom transformation was used to reduce skewness in the measures. The design factors and baseline covariates were controlled in the model.|Blom transformed outcome was used and the design factors and baseline covariates were controlled in the model to get the adjusted means. After that, the effect size (defined in the Additional details) was calculated using the adjusted means and SD.|Effect size was defined as training improvement from baseline to year 10 minus control improvement from baseline to year 10 divided by the intrasubject standard deviation (SD) of the composite score. Positive effect sizes indicate improvement.||0.16|-0.29|0.45
72428876|NCT03257995|144368741|OTHER||Mean Difference (Final Values)|0.1619|||<|0.001|TWO_SIDED|95.0|0.087|0.2369|||ANOVA|||12 hour||0.2369|0.0870|<0.001
72428877|NCT03257995|144368741|OTHER||Mean Difference (Final Values)|0.1249|||<|0.001|TWO_SIDED|95.0|0.048|0.2018|||ANOVA|||23 hour 15 min||0.2018|0.0480|<0.001
72345342|NCT00148941|144213534|NON_INFERIORITY|The objectives were achieved if for D, T, PT, FHA and PRN: the upper limit of the two-sided standardized asymptotic 95% CI of the difference in booster response rates was less than or equal to the pre-defined clinical limit of 10% AND for poliovirus types 1, 2 and 3: the upper limit of the two-sided 95% confidence interval (CI) for the GMT ratio was less than or equal to the pre-defined clinical limit of 1.5.|GMT ratio|0.938|||||TWO_SIDED|95.0|0.811|1.085|||ANCOVA|ANCOVA model: adjustment for baseline titer - pooled variance||Analysis of the non-inferiority of SB213503 vaccine compared to Infanrix + IPOL administered separately in terms of anti-poliovirus type 3 (measured by the GMT ratio of Infanrix + IPOL + M-M-R Group over SB213503 + M-M-R Group = pooled lot 1, 2 \& 3 groups) in a subset of subjects one month after vaccination when co-administered with M-M-R II.|SB213503 lot 1, SB213503 lot 2, and SB213503 lot 3 Arms/Groups were pooled for statistical analysis.|1.085|0.811|
72345343|NCT00148941|144213535|NON_INFERIORITY|The objectives were achieved if for D, T, PT, FHA and PRN: the upper limit of the two-sided standardized asymptotic 95% CI of the difference in booster response rates was less than or equal to the pre-defined clinical limit of 10% AND for poliovirus types 1, 2 and 3: the upper limit of the two-sided 95% confidence interval (CI) for the GMT ratio was less than or equal to the pre-defined clinical limit of 1.5.|Difference between groups|0.47|||||TWO_SIDED|95.0|-0.98|1.21||||||Analysis of the non-inferiority of SB213503 vaccine compared to Infanrix + IPOL administered separately in terms of diphtheria toxoid (D) booster responses (i.e measured by the difference in percentage of subjects with a booster response between the Infanrix + IPOL + M-M-R Group and (minus) the SB213503 + M-M-R Group = pooled lot 1, 2 \& 3 groups) in a subset of subjects one month after vaccination when co-administered with M-M-R II.|SB213503 lot 1, SB213503 lot 2, and SB213503 lot 3 Arms/Groups were pooled for statistical analysis.|1.21|-0.98|
72345344|NCT00148941|144213535|NON_INFERIORITY|The objectives were achieved if for D, T, PT, FHA and PRN: the upper limit of the two-sided standardized asymptotic 95% CI of the difference in booster response rates was less than or equal to the pre-defined clinical limit of 10% AND for poliovirus types 1, 2 and 3: the upper limit of the two-sided 95% confidence interval (CI) for the GMT ratio was less than or equal to the pre-defined clinical limit of 1.5.|Difference between groups|-2.81|||||TWO_SIDED|95.0|-6.55|-0.09||||||Analysis of the non-inferiority of SB213503 vaccine compared to Infanrix + IPOL administered separately in terms of tetanus toxoid (T) booster responses (measured by the difference in percentage of subjects with a booster response between the Infanrix + IPOL + M-M-R Group and (minus) the SB213503 + M-M-R Group = pooled lot 1, 2 \& 3 groups) in a subset of subjects one month after vaccination when co-administered with M-M-R II.|SB213503 lot 1, SB213503 lot 2, and SB213503 lot 3 Arms/Groups were pooled for statistical analysis.|-0.09|-6.55|
72345345|NCT00148941|144213536|NON_INFERIORITY|The objectives were achieved if for D, T, PT, FHA and PRN: the upper limit of the two-sided standardized asymptotic 95% CI of the difference in booster response rates was less than or equal to the pre-defined clinical limit of 10% AND for poliovirus types 1, 2 and 3: the upper limit of the two-sided 95% confidence interval (CI) for the GMT ratio was less than or equal to the pre-defined clinical limit of 1.5.|Difference between groups|0.36|||||TWO_SIDED|95.0|-3.83|3.71||||||Analysis of the non-inferiority of SB213503 vaccine compared to Infanrix + IPOL administered separately in terms of pertussis toxoid (PT) booster responses (measured by the difference in percentage of subjects with a booster response between the Infanrix + IPOL + M-M-R Group and (minus) the SB213503 + M-M-R Group = pooled lot 1, 2 \& 3 groups) in a subset of subjects one month after vaccination when co-administered with M-M-R II.|SB213503 lot 1, SB213503 lot 2, and SB213503 lot 3 Arms/Groups were pooled for statistical analysis.|3.71|-3.83|
72345346|NCT00148941|144213536|NON_INFERIORITY|The objectives were achieved if for D, T, PT, FHA and PRN: the upper limit of the two-sided standardized asymptotic 95% CI of the difference in booster response rates was less than or equal to the pre-defined clinical limit of 10% AND for poliovirus types 1, 2 and 3: the upper limit of the two-sided 95% confidence interval (CI) for the GMT ratio was less than or equal to the pre-defined clinical limit of 1.5.|Difference between groups|0.79|||||TWO_SIDED|95.0|-2.5|3.21||||||Analysis of the non-inferiority of SB213503 vaccine compared to Infanrix + IPOL administered separately in terms of filamentous haemagglutinin (FHA) booster responses (measured by the difference in percentage of subjects with a booster response between the Infanrix + IPOL + M-M-R Group and (minus) the SB213503 + M-M-R Group = pooled lot 1, 2 \& 3 groups) in a subset of subjects one month after vaccination when co-administered with M-M-R II.|SB213503 lot 1, SB213503 lot 2, and SB213503 lot 3 Arms/Groups were pooled for statistical analysis.|3.21|-2.50|
72345347|NCT00148941|144213536|NON_INFERIORITY|The objectives were achieved if for D, T, PT, FHA and PRN: the upper limit of the two-sided standardized asymptotic 95% CI of the difference in booster response rates was less than or equal to the pre-defined clinical limit of 10% AND for poliovirus types 1, 2 and 3: the upper limit of the two-sided 95% confidence interval (CI) for the GMT ratio was less than or equal to the pre-defined clinical limit of 1.5.|Difference between groups|-0.82|||||TWO_SIDED|95.0|-3.79|1.14||||||Analysis of the non-inferiority of SB213503 vaccine compared to Infanrix + IPOL administered separately in terms of pertactin (PRN) booster responses (measured by the difference in percentage of subjects with a booster response between the Infanrix + IPOL + M-M-R Group and (minus) the SB213503 + M-M-R Group = pooled lot 1, 2 \& 3 groups) in a subset of subjects one month after vaccination when co-administered with M-M-R II.|SB213503 lot 1, SB213503 lot 2, and SB213503 lot 3 Arms/Groups were pooled for statistical analysis.|1.14|-3.79|
72368383|NCT00298558|144246921|SUPERIORITY_OR_OTHER||Effect Size|0.005||||0.95|TWO_SIDED|99.0|-0.22|0.23|||Mixed Models Analysis|The blom transformation was used to reduce skewness in the measures. The design factors and baseline covariates were controlled in the model.|Blom transformed outcome was used and the design factors and baseline covariates were controlled in the model to get the adjusted means. After that, the effect size (defined in the Additional details) was calculated using the adjusted means and SD.|Effect size was defined as training improvement from baseline to year 10 minus control improvement from baseline to year 10 divided by the intrasubject standard deviation (SD) of the composite score. Positive effect sizes indicate improvement.||0.23|-0.22|0.95
72428878|NCT03257995|144368741|OTHER||Mean Difference (Final Values)|0.1546|||<|0.001|TWO_SIDED|95.0|0.0777|0.2315|||ANOVA|||23 hour 45 min||0.2315|0.0777|<0.001
72428879|NCT03257995|144368742|OTHER||Mean Difference (Final Values)|5.0|||<|0.001|TWO_SIDED|95.0|3.1|7.0|||ANOVA|||5 min||7.0|3.1|<0.001
72428880|NCT03257995|144368742|OTHER||Mean Difference (Final Values)|6.0|||<|0.001|TWO_SIDED|95.0|4.0|7.9|||ANOVA|||15 min||7.9|4|<0.001
72428881|NCT03257995|144368742|OTHER||Mean Difference (Final Values)|6.6|||<|0.001|TWO_SIDED|95.0|4.6|8.5|||ANOVA|||30 min||8.5|4.6|<0.001
72345348|NCT00148941|144213537|NON_INFERIORITY|Non-inferiority objective was considered demonstrated, when the upper limit of the 95% CI for the difference between groups (SB213503 + M-M-R Group = pooled lot 1, 2 \& 3 groups minus Infanrix + IPOL + M-M-R Group) in percentage of subjects reporting increased circumferential swelling was equal or less than 2%.|Difference in percentage|-0.41|||||TWO_SIDED|95.0|-1.26|0.16||||||Non-inferiority of the SB213503 vaccine compared to Infanrix + IPOL administered separately in terms of the incidence of increased circumferential swelling at the SB213503 and Infanrix injection site, defined as an injection site swelling diameter that involves \> 50% of the length of the upper arm that also is associated with a \> 30 mm increase of the mid-upper arm circumference compared to the baseline measurement.|SB213503 lot 1, SB213503 lot 2, and SB213503 lot 3 Arms/Groups were pooled for statistical analysis.|0.16|-1.26|
72345349|NCT02160145|144213618|OTHER||Treatment difference|1.271|||<|0.0001|TWO_SIDED|95.0|0.859|1.684||A 2-sided alpha of 0.05 was applied to the primary analysis of the primary endpoint.|ANCOVA|Weighted Analysis of Covariance (ANCOVA) with effects of treatment and randomization stratification factors and covariate baseline.||Tolvaptan versus placebo. Treatment difference in the change of eGFR assessed the efficacy of tolvaptan treatment as compared with placebo in subjects with late-stage CKD due to ADPKD who tolerated tolvaptan during an initial run-in period.||1.684|0.859|<0.0001
72345350|NCT02160145|144213619|OTHER||Treatment difference|1.011|||<|0.0001|TWO_SIDED|95.0|0.618|1.403||A two-sided alpha of 0.05 was applied when the primary endpoint reached a two-sided alpha of 0.05.|Mixed Models Analysis|||Difference in treatment effect was derived from a linear mixed model with effects of treatment, time, treatment ime interaction, acute haemodynamic effect, pretreatment baseline, and randomization stratification factors. An unstructured variance matrix was assumed for the random intercept and time.||1.403|0.618|<0.0001
72345351|NCT02921087|144213631|SUPERIORITY|||||||0.07|||||||Mixed Models Analysis|Least-squares adjusted means were obtained and compared.||In order to analyze the 2 x 2 crossover design for the primary outcome (change in overall VAS at day 7) mixed model analysis was utilized, allowing the sequences of each subject to be modeled as repeated measures within PROC Mixed.||||0.07
72345352|NCT02921087|144213633|SUPERIORITY|||||||0.01|||||||Mixed Models Analysis|Least-squares adjusted means were obtained and compared.||In order to analyze the 2 x 2 crossover design for accommodative response mixed model analysis was utilized, allowing the sequences of each subject to be modeled as repeated measures within PROC Mixed.||||0.01
72345353|NCT02921087|144213634|SUPERIORITY|||||||0.77|||||||Mixed Models Analysis|Least-squares adjusted means were obtained and compared.||In order to analyze the 2 x 2 crossover design for the change in CISS, mixed model analysis was utilized, allowing the sequences of each subject to be modeled as repeated measures within PROC Mixed.||||0.77
72345354|NCT02921087|144213635|SUPERIORITY|||||||0.69|||||||Mixed Models Analysis|Least-squares adjusted means were obtained and compared.||In order to analyze the 2 x 2 crossover design for the CLDEQ-8, mixed model analysis was utilized, allowing the sequences of each subject to be modeled as repeated measures within PROC Mixed.||||0.69
72345355|NCT02921087|144213636|SUPERIORITY|||||||0.87|||||||Mixed Models Analysis|Least-squares adjusted means were obtained and compared.||In order to analyze the 2 x 2 crossover design for phoria, mixed model analysis was utilized, allowing the sequences of each subject to be modeled as repeated measures within PROC Mixed.||||0.87
72345356|NCT01031979|144213801|SUPERIORITY_OR_OTHER||Beta|-1.44|||<|0.001|TWO_SIDED|95.0|-2.29|-0.59|||mixed effects/hierarchical linear model|||||-0.59|-2.29|<0.001
72345357|NCT01031979|144213802|SUPERIORITY_OR_OTHER||Slope|-0.87||||0.39|TWO_SIDED||||||Hierarchical Linear Modeling|||||||.39
72428882|NCT03257995|144368742|OTHER||Mean Difference (Final Values)|5.5|||<|0.001|TWO_SIDED|95.0|3.5|7.4|||ANOVA|||1 hour||7.4|3.5|<0.001
72345358|NCT01031979|144213803|SUPERIORITY_OR_OTHER||Slope|-0.55||||0.58|TWO_SIDED||||||Hierarchical Linear Modeling|||||||.58
72345359|NCT01031979|144213804|SUPERIORITY_OR_OTHER||Beta|-1.6||||0.03|TWO_SIDED|95.0|-2.71|-0.49|||Hierarchical Linear Modeling|||||-0.49|-2.71|.03
72345360|NCT03831100|144213808|SUPERIORITY||Mean Difference (Net)|-2.1||||0.25|TWO_SIDED|90.0|-5.0|0.9||A two-sided P \< .10 indicates the a priori threshold for statistical significance. P-values are not adjusted for multiple comparisons.|Regression, Linear||The mean for each study arm represents the mean difference in the score at the post-treatment timepoint relative to the score at baseline. The mean difference (net) represents the mean model-based difference between study arms.|||0.9|-5.0|0.25
72345361|NCT03831100|144213809|SUPERIORITY||Mean Difference (Net)|-5.8||||0.006|TWO_SIDED|90.0|-9.1|-2.5||A two-sided P \< .10 indicates the a priori threshold for statistical significance. P-values are not adjusted for multiple comparisons.|Regression, Linear||The mean for each study arm represents the mean difference in the score at the post-treatment timepoint relative to the score at baseline. The mean difference (net) represents the mean model-based difference between study arms.|||-2.5|-9.1|.006
72345362|NCT03831100|144213810|SUPERIORITY||Mean Difference (Net)|-7.9||||0.1|TWO_SIDED|90.0|-15.9|0.0||A two-sided P \< .10 indicates the a priori threshold for statistical significance. P-values are not adjusted for multiple comparisons.|Regression, Linear||The mean for each study arm represents the mean difference in the score at the post-treatment timepoint relative to the score at baseline. The mean difference (net) represents the mean model-based difference between study arms.|||0.0|-15.9|.10
72345363|NCT03831100|144213811|SUPERIORITY||Mean Difference (Net)|-17.1||||0.002|TWO_SIDED|90.0|-25.6|-8.6||A two-sided P \< .10 indicates the a priori threshold for statistical significance. P-values are not adjusted for multiple comparisons.|Regression, Linear|||||-8.6|-25.6|.002
72345364|NCT03831100|144213812|SUPERIORITY||Mean Difference (Net)|-3.4||||0.3|TWO_SIDED|90.0|-8.8|2.0||A two-sided P \< .10 indicates the a priori threshold for statistical significance. P-values are not adjusted for multiple comparisons.|ANCOVA||Model-based treatment effect estimated using ANCOVA with change score modeled as a function of treatment group (AC, BRIGHT/Therapist A, BRIGHT/Therapist B), with adjustment for baseline scores|||2.0|-8.8|0.30
72428883|NCT03257995|144368742|OTHER||Mean Difference (Final Values)|4.7|||<|0.001|TWO_SIDED|95.0|2.8|6.7|||ANOVA|||2 hour||6.7|2.8|<0.001
72428884|NCT03257995|144368742|OTHER||Mean Difference (Final Values)|4.3|||<|0.001|TWO_SIDED|95.0|2.3|6.3|||ANOVA|||4 hour||6.3|2.3|<0.001
72428885|NCT03257995|144368742|OTHER||Mean Difference (Final Values)|5.0|||<|0.001|TWO_SIDED|95.0|3.0|7.0|||ANOVA|||8 hour||7|3|<0.001
72428886|NCT03257995|144368742|OTHER||Mean Difference (Final Values)|4.5|||<|0.001|TWO_SIDED|95.0|2.5|6.5|||ANOVA|||12 hour||6.5|2.5|<0.001
72345365|NCT03831100|144213813|SUPERIORITY||Median Difference (Net)|-9.7||||0.005|TWO_SIDED|90.0|-15.2|-4.2||A two-sided P \< .10 indicates the a priori threshold for statistical significance. P-values are not adjusted for multiple comparisons.|ANCOVA||Model-based treatment effect estimated using ANCOVA with change score modeled as a function of treatment group (AC, BRIGHT/Therapist A, BRIGHT/Therapist B), with adjustment for baseline scores.|||-4.2|-15.2|0.005
72345366|NCT03831100|144213814|SUPERIORITY||Mean Difference (Net)|-3.4||||0.064|TWO_SIDED|90.0|-6.4|0.4||A two-sided P \< .10 indicates the a priori threshold for statistical significance. P-values are not adjusted for multiple comparisons.|ANCOVA||Model-based treatment effect estimated using ANCOVA with change score modeled as a function of treatment group (AC, BRIGHT/Therapist A, BRIGHT/Therapist B), with adjustment for baseline scores.|||0.4|-6.4|0.064
72345367|NCT03831100|144213815|SUPERIORITY||Mean Difference (Net)|-4.3||||0.046|TWO_SIDED|90.0|-7.8|-0.8||A two-sided P \< .10 indicates the a priori threshold for statistical significance. P-values are not adjusted for multiple comparisons.|ANCOVA||Model-based treatment effect estimated using ANCOVA with change score modeled as a function of treatment group (AC, BRIGHT/Therapist A, BRIGHT/Therapist B), with adjustment for baseline scores.|||-0.8|-7.8|0.046
72345368|NCT03831100|144213816|SUPERIORITY||Mean Difference (Net)|-1.5||||0.49|TWO_SIDED|90.0|-5.2|2.1||A two-sided P \< .10 indicates the a priori threshold for statistical significance. P-values are not adjusted for multiple comparisons.|ANCOVA||Model-based treatment effect estimated using ANCOVA with change score modeled as a function of treatment group (AC, BRIGHT/Therapist A, BRIGHT/Therapist B), with adjustment for baseline scores.|||2.1|-5.2|0.49
72345369|NCT03831100|144213817|SUPERIORITY||Mean Difference (Net)|-3.1||||0.14|TWO_SIDED|90.0|-6.5|0.3||A two-sided P \< .10 indicates the a priori threshold for statistical significance. P-values are not adjusted for multiple comparisons.|ANCOVA||Model-based treatment effect estimated using ANCOVA with change score modeled as a function of treatment group (AC, BRIGHT/Therapist A, BRIGHT/Therapist B), with adjustment for baseline scores.|||0.3|-6.5|0.14
72345370|NCT03831100|144213818|SUPERIORITY||Mean Difference (Net)|3.2||||0.082|TWO_SIDED|90.0|0.2|6.3||A two-sided P \< .10 indicates the a priori threshold for statistical significance. P-values are not adjusted for multiple comparisons.|ANCOVA||Model-based treatment effect estimated using ANCOVA with change score modeled as a function of treatment group (AC, BRIGHT/Therapist A, BRIGHT/Therapist B), with adjustment for baseline scores.|||6.3|0.2|0.082
72345371|NCT03831100|144213819|SUPERIORITY||Mean Difference (Net)|2.7||||0.15|TWO_SIDED|90.0|-0.4|5.7||A two-sided P \< .10 indicates the a priori threshold for statistical significance. P-values are not adjusted for multiple comparisons.|ANCOVA||Model-based treatment effect estimated using ANCOVA with change score modeled as a function of treatment group (AC, BRIGHT/Therapist A, BRIGHT/Therapist B), with adjustment for baseline scores.|||5.7|-0.4|0.15
72345372|NCT03831100|144213820|SUPERIORITY||Mean Difference (Net)|-2.2||||0.22|TWO_SIDED|90.0|-5.2|-0.7||A two-sided P \< .10 indicates the a priori threshold for statistical significance. P-values are not adjusted for multiple comparisons.|ANCOVA||Model-based treatment effect estimated using ANCOVA with change score modeled as a function of treatment group (AC, BRIGHT/Therapist A, BRIGHT/Therapist B), with adjustment for baseline scores.|||-0.7|-5.2|0.22
72345373|NCT03831100|144213821|SUPERIORITY||Mean Difference (Net)|-2.9||||0.093|TWO_SIDED|90.0|-5.8|-0.1||A two-sided P \< .10 indicates the a priori threshold for statistical significance. P-values are not adjusted for multiple comparisons.|ANCOVA||Model-based treatment effect estimated using ANCOVA with change score modeled as a function of treatment group (AC, BRIGHT/Therapist A, BRIGHT/Therapist B), with adjustment for baseline scores.|||-0.1|-5.8|0.093
72345374|NCT01618695|144213848|SUPERIORITY||Median Difference (Final Values)|-5.09||||0.233|TWO_SIDED|95.0|-14.112|4.519|||ANCOVA||Median Difference to placebo and the 95 percent (%) confidence interval are based on the Hodges-Lehmann method.|||4.519|-14.112|0.2330
72345375|NCT01618695|144213848|SUPERIORITY||Median Difference (Final Values)|-16.45||||0.0003|TWO_SIDED|95.0|-25.683|-7.251|||ANCOVA||Median Difference to placebo and the 95% confidence interval are based on the Hodges-Lehmann method.|||-7.251|-25.683|0.0003
72345376|NCT01618695|144213848|SUPERIORITY||Median Difference (Final Values)|-24.95|||<|0.0001|TWO_SIDED|95.0|-33.878|-16.235|||ANCOVA||Median Difference to placebo and the 95% confidence interval are based on the Hodges-Lehmann method.|||-16.235|-33.878|<0.0001
72345377|NCT01618695|144213849|SUPERIORITY|||||||0.3954|||||||Cochran-Mantel-Haenszel|||||||0.3954
72345378|NCT01618695|144213849|SUPERIORITY|||||||0.0005|||||||Cochran-Mantel-Haenszel|||||||0.0005
72345379|NCT01618695|144213849|SUPERIORITY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
72345380|NCT01618695|144213850|SUPERIORITY||Median Difference (Final Values)|-8.27||||0.0552|TWO_SIDED|95.0|-18.067|1.671|||ANCOVA||Median Difference to placebo and the 95% confidence interval are based on the Hodges-Lehmann method.|||1.671|-18.067|0.0552
72345381|NCT01618695|144213850|SUPERIORITY||Median Difference (Final Values)|-21.21|||<|0.0001|TWO_SIDED|95.0|-30.941|-11.368|||ANCOVA||Median Difference to placebo and the 95% confidence interval are based on the Hodges-Lehmann method.|||-11.368|-30.941|<0.0001
72345382|NCT01618695|144213850|SUPERIORITY||Median Difference (Final Values)|-28.65|||<|0.0001|TWO_SIDED|95.0|-37.698|-19.794|||ANCOVA||Median Difference to placebo and the 95% confidence interval are based on the Hodges-Lehmann method.|||-19.794|-37.698|<0.0001
72345383|NCT01128192|144213865|SUPERIORITY_OR_OTHER|||||||0.24|TWO_SIDED|||||Two sided P value|ANOVA|||Change in fasting plasma glucose level||||0.240
72345384|NCT01128192|144213865|SUPERIORITY_OR_OTHER|||||||0.339|TWO_SIDED|||||Two sided P value.|ANOVA|||Change in fasting plasma glucose level||||0.339
72345385|NCT01128192|144213866|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Two sided P value.|ANOVA|||Pre and Post treatment Area Under the Curve (AUC) 0-30 minutes||||<0.001
72345386|NCT01128192|144213866|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Two sided P Value.|ANOVA|||Pre and Post treatment Area Under the Curve (AUC) 30-180 minutes||||<0.001
72345387|NCT01128192|144213866|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Two sided P Value|ANOVA|||Pre and Post treatment Area Under the Curve (AUC) 0-180 minutes||||<0.001
72345388|NCT01128192|144213866|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Two sided P value.|ANOVA|||Pre and Post treatment Area Under the Curve (AUC) 0-30 minutes||||<0.001
72345389|NCT01128192|144213866|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Two sided P value.|ANOVA|||Pre and Post treatment Area Under the Curve (AUC) 30-180 minutes||||<0.001
72345390|NCT01128192|144213866|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Two sided P value.|ANOVA|||Pre and Post treatment Area Under the Curve (AUC) 0-180 minutes||||<0.001
72428887|NCT03257995|144368742|OTHER||Mean Difference (Final Values)|4.6|||<|0.001|TWO_SIDED|95.0|2.6|6.7|||ANOVA|||23 hour 15 min||6.7|2.6|<0.001
72428888|NCT03257995|144368742|OTHER||Mean Difference (Final Values)|4.1|||<|0.001|TWO_SIDED|95.0|2.0|6.2|||ANOVA|||23 hour 45 min||6.2|2.0|<0.001
72428889|NCT03257995|144368742|OTHER||Mean Difference (Final Values)|5.8|||<|0.001|TWO_SIDED|95.0|3.9|7.8|||ANOVA|||5 min||7.8|3.9|<0.001
72428890|NCT03257995|144368742|OTHER||Mean Difference (Final Values)|5.8|||<|0.001|TWO_SIDED|95.0|3.9|7.8|||ANOVA|||15 min||7.8|3.9|<0.001
72428891|NCT03257995|144368742|OTHER||Mean Difference (Final Values)|6.3|||<|0.001|TWO_SIDED|95.0|4.4|8.3|||ANOVA|||30 min||8.3|4.4|<0.001
72428892|NCT03257995|144368742|OTHER||Mean Difference (Final Values)|5.5|||<|0.001|TWO_SIDED|95.0|3.5|7.5|||ANOVA|||1 hour||7.5|3.5|<0.001
72428893|NCT03257995|144368742|OTHER||Mean Difference (Final Values)|5.5|||<|0.001|TWO_SIDED|95.0|3.5|7.4|||ANOVA|||2 hour||7.4|3.5|<0.001
72428894|NCT03257995|144368742|OTHER||Mean Difference (Final Values)|5.0|||<|0.001|TWO_SIDED|95.0|3.1|7.0|||ANOVA|||4 hour||7.0|3.1|<0.001
72428895|NCT03257995|144368742|OTHER||Mean Difference (Final Values)|5.0|||<|0.001|TWO_SIDED|95.0|3.0|7.0|||ANOVA|||8 hour||7.0|3.0|<0.001
72428896|NCT03257995|144368742|OTHER||Mean Difference (Final Values)|4.2|||<|0.001|TWO_SIDED|95.0|2.2|6.2|||ANOVA|||12 hour||6.2|2.2|<0.001
72345391|NCT01128192|144213867|SUPERIORITY_OR_OTHER|||||||0.019|TWO_SIDED|||||Two sided P value.|ANOVA|||Change in fasting plasma insulin level||||0.019
72345392|NCT01128192|144213867|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Two sided P value.|ANOVA|||Change in fasting plasma insulin level||||<0.001
72345393|NCT01128192|144213868|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Two sided P value.|ANOVA|||Pre and Post treatment Area Under the Curve (AUC) 0-30 minutes||||<0.001
72345394|NCT01128192|144213868|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Two sided P value|ANOVA|||Pre and Post treatment Area Under the Curve (AUC) 30-180 minutes||||<0.001
72345395|NCT01128192|144213868|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Two sided P value.|ANOVA|||Pre and Post treatment Area Under the Curve (AUC) 0-180 minutes||||<0.001
72428897|NCT03257995|144368742|OTHER||Mean Difference (Final Values)|3.0||||0.004|TWO_SIDED|95.0|1.0|5.0|||ANOVA|||23 hour 15 min||5.0|1.0|0.004
72428898|NCT03257995|144368742|OTHER||Mean Difference (Final Values)|4.1|||<|0.001|TWO_SIDED|95.0|2.1|6.1|||ANOVA|||23 hour 45 min||6.1|2.1|<0.001
72428899|NCT03257995|144368743|OTHER||Mean Difference (Final Values)|0.0249|||<|0.001|TWO_SIDED|95.0|0.0139|0.0359|||ANOVA|||5 min||0.0359|0.0139|<.001
72428900|NCT03257995|144368743|OTHER||Mean Difference (Final Values)|0.033|||<|0.001|TWO_SIDED|95.0|0.022|0.044|||ANOVA|||15 min||0.0440|0.0220|<.001
72428901|NCT03257995|144368743|OTHER||Mean Difference (Final Values)|0.0306|||<|0.001|TWO_SIDED|95.0|0.0197|0.0416|||ANOVA|||30 min||0.0416|0.0197|<0.001
72428902|NCT03257995|144368743|OTHER||Mean Difference (Final Values)|0.0324|||<|0.001|TWO_SIDED|95.0|0.0214|0.0434|||ANOVA|||1 hour||0.0434|0.0214|<0.001
72428903|NCT03257995|144368743|OTHER||Mean Difference (Final Values)|0.0338|||<|0.001|TWO_SIDED|95.0|0.0228|0.0447|||ANOVA|||2 hour||0.0447|0.0228|<0.001
72428904|NCT03257995|144368743|OTHER||Mean Difference (Final Values)|0.0325|||<|0.001|TWO_SIDED|95.0|0.0215|0.0435|||ANOVA|||4 hour||0.0435|0.0215|<0.001
72428905|NCT03257995|144368743|OTHER||Mean Difference (Final Values)|0.0311|||<|0.001|TWO_SIDED|95.0|0.02|0.0422|||ANOVA|||8 hour||0.0422|0.0200|<0.001
72428906|NCT03257995|144368743|OTHER||Mean Difference (Final Values)|0.0359|||<|0.001|TWO_SIDED|95.0|0.0248|0.047|||ANOVA|||12 hour||0.0470|0.0248|<0.001
72428907|NCT03257995|144368743|OTHER||Mean Difference (Final Values)|0.0326|||<|0.001|TWO_SIDED|95.0|0.0211|0.044|||ANOVA|||23 hour 15 min||0.0440|0.0211|<0.001
72428908|NCT03257995|144368743|OTHER||Mean Difference (Final Values)|0.0301|||<|0.001|TWO_SIDED|95.0|0.0187|0.0415|||ANOVA|||23 hour 45 min||0.0415|0.0187|<0.001
72428909|NCT03257995|144368743|OTHER||Mean Difference (Final Values)|0.0222|||<|0.001|TWO_SIDED|95.0|0.0113|0.0332|||ANOVA|||5 min||0.0332|0.0113|<0.001
72428910|NCT03257995|144368743|OTHER||Mean Difference (Final Values)|0.0344|||<|0.001|TWO_SIDED|95.0|0.0234|0.0454|||ANOVA|||15 min||0.0454|0.0234|<0.001
72428911|NCT03257995|144368743|OTHER||Mean Difference (Final Values)|0.029|||<|0.001|TWO_SIDED|95.0|0.018|0.0399|||ANOVA|||30 min||0.0399|0.0180|<0.001
72428912|NCT03257995|144368743|OTHER||Mean Difference (Final Values)|0.0278|||<|0.001|TWO_SIDED|95.0|0.0169|0.0387|||ANOVA|||1 hour||0.0387|0.0169|<0.001
72428913|NCT03257995|144368743|OTHER||Mean Difference (Final Values)|0.0338|||<|0.001|TWO_SIDED|95.0|0.0228|0.0447|||ANOVA|||2 hour||0.0447|0.0228|<0.001
72428914|NCT03257995|144368743|OTHER||Mean Difference (Final Values)|0.0278|||<|0.001|TWO_SIDED|95.0|0.0168|0.0387|||ANOVA|||4 hour||0.0387|0.0168|<0.001
72428915|NCT03257995|144368743|OTHER||Mean Difference (Final Values)|0.0316|||<|0.001|TWO_SIDED|95.0|0.0206|0.0426|||ANOVA|||8 hour||0.0426|0.0206|<0.001
72428916|NCT03257995|144368743|OTHER||Mean Difference (Final Values)|0.0285|||<|0.001|TWO_SIDED|95.0|0.0175|0.0396|||ANOVA|||12 hour||0.0396|0.0175|<0.001
72428917|NCT03257995|144368743|OTHER||Mean Difference (Final Values)|0.0281|||<|0.001|TWO_SIDED|95.0|0.0167|0.0394|||ANOVA|||23 hour 15 min||0.0394|0.0167|<0.001
72428918|NCT03257995|144368743|OTHER||Mean Difference (Final Values)|0.0266|||<|0.001|TWO_SIDED|95.0|0.0152|0.0379|||ANOVA|||23 hour 45 min||0.0379|0.0152|<0.001
72428919|NCT03257995|144368744|OTHER||Mean Difference (Final Values)|0.2025|||<|0.001|TWO_SIDED|95.0|0.1059|0.2952|||ANOVA|||5 min||0.2952|0.1059|<0.001
72428920|NCT03257995|144368744|OTHER||Mean Difference (Final Values)|0.2923|||<|0.001|TWO_SIDED|95.0|0.1979|0.3867|||ANOVA|||15 min||0.3867|0.1979|<0.001
72428921|NCT03257995|144368744|OTHER||Mean Difference (Final Values)|0.2657|||<|0.001|TWO_SIDED|95.0|0.1713|0.3601|||ANOVA|||30 min||0.3601|0.1713|<0.001
72428922|NCT03257995|144368744|OTHER||Mean Difference (Final Values)|0.2752|||<|0.001|TWO_SIDED|95.0|0.1808|0.3696|||ANOVA|||1 hour||0.3696|0.1808|<0.001
72428923|NCT03257995|144368744|OTHER||Mean Difference (Final Values)|0.2819|||<|0.001|TWO_SIDED|95.0|0.1875|0.3763|||ANOVA|||2 hours||0.3763|0.1875|<0.001
72428924|NCT03257995|144368744|OTHER||Mean Difference (Final Values)|0.282|||<|0.001|TWO_SIDED|95.0|0.1874|0.3766|||ANOVA|||4 hours||0.3766|0.1874|<0.001
72428925|NCT03257995|144368744|OTHER||Mean Difference (Final Values)|0.2538|||<|0.001|TWO_SIDED|95.0|0.1585|0.3492|||ANOVA|||8 hours||0.3492|0.1585|<0.001
72428926|NCT03257995|144368744|OTHER||Mean Difference (Final Values)|0.2687|||<|0.001|TWO_SIDED|95.0|0.1732|0.3643|||ANOVA|||12 hours||0.3643|0.1732|<0.001
72428927|NCT03257995|144368744|OTHER||Mean Difference (Final Values)|0.2453|||<|0.001|TWO_SIDED|95.0|0.1473|0.3434|||ANOVA|||23 hours 15 min||0.3434|0.1473|<0.001
72345396|NCT01128192|144213868|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Two sided P value.|ANOVA|||Pre and Post treatment Area Under the Curve (AUC) 0-30 minutes||||<0.001
72345397|NCT01128192|144213868|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Two sided P value.|ANOVA|||Pre and Post treatment Area Under the Curve (AUC) 30-180 minutes||||<0.001
72345398|NCT01128192|144213868|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Two sided P value.|ANOVA|||Pre and Post treatment Area Under the Curve (AUC) 0-180 minutes||||<0.001
72345399|NCT01128192|144213869|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Two sided P value.|ANOVA|||Change in Baseline Insulin Level||||<0.001
72345400|NCT01128192|144213869|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Two sided P value|ANOVA|||Change in Baseline Insulin Level||||<0.001
72345401|NCT01128192|144213870|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Two sided P value.|ANOVA|||Pre and Post treatment Area Under the Curve (AUC) 0-10 minutes||||<0.001
72345402|NCT01128192|144213870|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Two sided P value|ANOVA|||Pre and Post treatment Area Under the Curve (AUC) 10-180 minutes||||<0.001
72345403|NCT01128192|144213870|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Two sided P value|ANOVA|||Pre and Post treatment Area Under the Curve (AUC) 0-180 minutes||||<0.001
72345404|NCT01128192|144213870|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Two sided P value|ANOVA|||Pre and Post treatment Area Under the Curve (AUC) 0-10 minutes||||<0.001
72345405|NCT01128192|144213870|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Two sided P value.|ANOVA|||Pre and Post treatment Area Under the Curve (AUC) 10-180 minutes||||<0.001
72345406|NCT01128192|144213870|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Two sided P value.|ANOVA|||Pre and Post treatment Area Under the Curve (AUC) 0-180 minutes||||<0.001
72345407|NCT01128192|144213871|SUPERIORITY_OR_OTHER|||||||0.608|TWO_SIDED|||||Two sided P value.|ANOVA|||Change in Basal EGP||||0.608
72345408|NCT01128192|144213871|SUPERIORITY_OR_OTHER|||||||0.132|TWO_SIDED|||||Two sided P value.|ANOVA|||Change in Basal EGP||||0.132
72345409|NCT01128192|144213872|SUPERIORITY_OR_OTHER|||||||0.178|TWO_SIDED|||||Two sided P value.|ANOVA|||Change in Low-Dose % EGP Inhibition||||0.178
72345410|NCT01128192|144213872|SUPERIORITY_OR_OTHER|||||||0.111|TWO_SIDED|||||Two sided P value.|ANOVA|||Change in Low-Dose % EGP Inhibition||||0.111
72345411|NCT01128192|144213873|SUPERIORITY_OR_OTHER|||||||0.573|TWO_SIDED|||||Two sided P value.|ANOVA|||Change in high-dose % EGP Inhibition||||0.573
72345412|NCT01128192|144213874|SUPERIORITY_OR_OTHER|||||||0.956|TWO_SIDED|||||Two sided P value.|ANOVA|||Change in Low-Dose Glucose Disposal Rate (GDR)||||0.956
72345413|NCT01128192|144213874|SUPERIORITY_OR_OTHER|||||||0.125|TWO_SIDED|||||Two sided P value.|ANOVA|||Change in Low-Dose Glucose Disposal Rate (GDR)||||0.125
72345414|NCT01128192|144213875|SUPERIORITY_OR_OTHER|||||||0.993|TWO_SIDED|||||Two sided P value.|ANOVA|||Change in High-Dose Glucose Disposal Rate (GDR)||||0.993
72345415|NCT01128192|144213875|SUPERIORITY_OR_OTHER|||||||0.956|TWO_SIDED|||||Two sided P value.|ANOVA|||Change in High-Dose Glucose Disposal Rate (GDR)||||0.956
72345416|NCT00746863|144213878|SUPERIORITY_OR_OTHER|||||||0.0251||95.0||||A Bonferroni correction was used when evaluating the VAS results to adjust for multiple comparisons.|Wilcoxon (Mann-Whitney)|||A 2.0 cm difference on a 10.0 cm VAS scale was clinically significant. Assuming a power of 80% to detect a 2.0 difference on scores between groups, standard deviation of 2.2, an α of 0.05, then, 21 patients would be needed in each group for a total of 42 subjects. A t-test was used in comparing the intervention and control groups, if continuous variables were approximately normal. If data were not approximately normal, a Mann-Whitney Wilcoxon test was used in comparing the two groups.||||0.0251
72345417|NCT00746863|144213879|SUPERIORITY_OR_OTHER|||||||0.0923||95.0||||Adjusted for multiple comparisions|Wilcoxon (Mann-Whitney)|||A t-test was used in comparing the intervention and control groups, if continuous variables were approximately normal. If data were not approximately normal, a Mann-Whitney Wilcoxon test was used in comparing the two groups.||||0.0923
72345418|NCT00746863|144213880|SUPERIORITY_OR_OTHER|||||||0.4756||95.0|||||Chi-squared|||Chi square was performed to compared the two groups and the patient's ability to pass their voiding trial prior to discharge||||0.4756
72345419|NCT00746863|144213881|SUPERIORITY_OR_OTHER|||||||0.258||95.0||||A Bonferroni correction was used when evaluating the VAS results to adjust for multiple comparisons.|Wilcoxon (Mann-Whitney)|||A t-test was used in comparing the intervention and control groups, if continuous variables were approximately normal. If data were not approximately normal, a Mann-Whitney Wilcoxon test was used in comparing the two groups. Normality of continuous variables was assessed using the Shapiro-Wilk test. For categorical data, Fisher's exact test was used to evaluate the data. A Bonferroni correction was used when evaluating the VAS results to adjust for multiple comparisons.||||0.258
72345420|NCT00746863|144213882|SUPERIORITY_OR_OTHER|||||||0.435||95.0||||A Bonferroni correction was used when evaluating the VAS results to adjust for multiple comparisons.|Wilcoxon (Mann-Whitney)|||A t-test was used in comparing the intervention and control groups, if continuous variables were approximately normal. If data were not approximately normal, a Mann-Whitney Wilcoxon test was used in comparing the two groups. Normality of continuous variables was assessed using the Shapiro-Wilk test. For categorical data, Fisher's exact test was used to evaluate the data. A Bonferroni correction was used when evaluating the VAS results to adjust for multiple comparisons.||||0.435
72345421|NCT04207749|144213884|NON_INFERIORITY|Noninferiority in CLCDVA was declared if the upper confidence limit was less than 0.10 logMAR.|Least Squares Mean Difference|0.01|||||TWO_SIDED|95.0|0.0|0.02||Since noninferiority hypotheses are being tested, a p-value is not applicable. Confidence limit is being reported and compared to the noninferiority margin.|Mixed effects repeated measures||Least squares mean difference (LID015385 minus Biofinity).|||0.02|-0.00|
72345422|NCT04207749|144213885|NON_INFERIORITY|Proportion of subjects is presented. Noninferiority in proportion of subjects achieving CLCDVA 20/20 or better in each eye was declared if the lower confidence limit was greater than -0.10.|Difference in proportion|-0.01|||||TWO_SIDED|95.0|-0.06|0.04||Since noninferiority hypotheses are being tested, a p-value is not applicable. Confidence limit is being reported and compared to the noninferiority margin.|Farrington-Manning||Lens difference (LID015385 minus Biofinity)|||0.04|-0.06|
72345423|NCT01504841|144213894|OTHER||%|36.4|||||TWO_SIDED|95.0|10.9|69.2|||||Exact Binomial (Clopper-Pearson) confidence intervals for Cohort I, percentage of participants who experienced a grade 3+ AE.|||69.2|10.9|
72345424|NCT01504841|144213894|OTHER||%|100.0|||||TWO_SIDED|95.0|39.8|100.0|||||Exact Binomial (Clopper-Pearson) confidence intervals for Cohort II, percentage of participants who experienced a grade 3+ AE.|||100|39.8|
72345425|NCT01504841|144213897|OTHER||%|18.2|||||TWO_SIDED|95.0|2.5|51.8|||||Exact Binomial (Clopper-Pearson) confidence intervals for Cohort I, percentage of participants who experienced a grade 3+ AE at least possibly related to study medications.|||51.8|2.5|
72345426|NCT01504841|144213897|OTHER||%|0.0|||||TWO_SIDED|95.0|0.0|60.2|||||Exact Binomial (Clopper-Pearson) confidence intervals for Cohort II, percentage of participants who experienced a grade 3+ AE at least possibly related to study medication.|||60.2|0|
72345427|NCT01504841|144213898|OTHER||%|18.2|||||TWO_SIDED|95.0|2.3|51.8|||||Exact Binomial (Clopper-Pearson) confidence intervals for Cohort I Week 24, percentage of participants who experienced Virologic Failure.|Week 24 time point.||51.8|2.3|
72345428|NCT01504841|144213898|OTHER||%|25.0|||||TWO_SIDED|95.0|0.6|80.6|||||Exact Binomial (Clopper-Pearson) confidence intervals for Cohort II Week 24, percentage of participants who experienced Virologic Failure.|Week 24 time point.||80.6|0.6|
72345429|NCT01504841|144213898|OTHER||%|27.3|||||TWO_SIDED|95.0|6.0|61.0|||||Exact Binomial (Clopper-Pearson) confidence intervals for Cohort I Week 48, percentage of participants who experienced Virologic Failure.|Week 48 time point.||61|6|
72345430|NCT01504841|144213898|OTHER||%|75.0|||||TWO_SIDED|95.0|19.4|99.4|||||Exact Binomial (Clopper-Pearson) confidence intervals for Cohort II Week 48, percentage of participants who experienced Virologic Failure.|Week 48 time point.||99.4|19.4|
72345431|NCT01504841|144213902|OTHER||%|9.1|||||TWO_SIDED|95.0|0.2|41.3|||||Exact Binomial (Clopper-Pearson) confidence intervals for Cohort I Week 12, percentage of participants with a \>5% decline in absolute CD4 %.|Week 12 time point.||41.3|0.2|
72345432|NCT01504841|144213902|OTHER||%|50.0|||||TWO_SIDED|95.0|6.8|93.2|||||Exact Binomial (Clopper-Pearson) confidence intervals for Cohort II Week 12, percentage of participants with a \>5% decline in absolute CD4 %.|Week 12 time point.||93.2|6.8|
72345433|NCT01504841|144213902|OTHER||%|9.1|||||TWO_SIDED|95.0|0.2|41.3|||||Exact Binomial (Clopper-Pearson) confidence intervals for Cohort I Week 24, percentage of participants with a \>5% decline in absolute CD4 %.|Week 24 time point.||41.3|0.2|
72345434|NCT01504841|144213902|OTHER||%|25.0|||||TWO_SIDED|95.0|0.6|80.6|||||Exact Binomial (Clopper-Pearson) confidence intervals for Cohort II Week 24, percentage of participants with a \>5% decline in absolute CD4 %.|Week 24 time point.||80.6|0.6|
72345435|NCT01504841|144213902|OTHER||%|18.2|||||TWO_SIDED|95.0|2.3|51.8|||||Exact Binomial (Clopper-Pearson) confidence intervals for Cohort I Week 48, percentage of participants with a \>5% decline in absolute CD4 %.|Week 48 time point.||51.8|2.3|
72345436|NCT01504841|144213902|OTHER||%|50.0|||||TWO_SIDED|95.0|6.8|93.2|||||Exact Binomial (Clopper-Pearson) confidence intervals for Cohort II Week 48, percentage of participants with a \>5% decline in absolute CD4 %.|Week 48 time point.||93.2|6.8|
72345437|NCT01496469|144213943|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.3||||0.882|TWO_SIDED|95.0|-3.9|3.4||Analysis of covariance (ANCOVA) model with treatment as a factor, and the baseline value and prior use of an ARB or an ACEi as covariates.|ANCOVA|||A total of 120 enrolled participants (60 participants per treatment group) was sufficient to achieve 80 percent (%) power to detect a difference of 6.0 mmHg between the placebo and febuxostat 80 mg treatment groups by a 2 sample t-test of the mean change from Baseline at Week 6 in 24-hour mean ambulatory SBP with a 2-sided significance level of 5%.||3.4|-3.9|0.882
72345438|NCT01496469|144213944|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.6||||0.613|TWO_SIDED|95.0|-1.9|3.2||Tested at 5% significance level.|ANCOVA|||ANCOVA model with treatment as a factor, and the baseline value and prior use of an ARB or an ACEi as covariates.||3.2|-1.9|0.613
72345439|NCT01496469|144213945|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-3.4|||<|0.001|TWO_SIDED|95.0|-3.9|-2.9||Tested at 5% significance level.|ANCOVA|||ANCOVA model with treatment as a factor, and the baseline value and prior use of an ARB or an ACEi as covariates.||-2.9|-3.9|<0.001
72345440|NCT01853878|144213954|EQUIVALENCE|P-value of the Wald test from a Cox regression model to test H0 = { HR=1} (Y = Time to Event)|Hazard Ratio (HR)|4.592||||0.1422|TWO_SIDED|95.0|0.6|35.167|||Regression, Cox|||Estimates of Hazard Ratio (HR) and their 95% Confidence Interval (CI) were obtained by Cox regression modelling.The Likelihood ratio test was used to compare the groups. The Cox proportional hazard regression was stratified by previous treatment \[Chemotherapy (CT) vs. no-CT\] and disease stage.||35.167|0.600|0.1422
72345441|NCT01399866|144213965|SUPERIORITY|||||||0.574|||||||ANOVA|||||||0.574
72345442|NCT01399866|144213965|SUPERIORITY|||||||0.747|||||||ANOVA|||||||0.747
72345443|NCT01399866|144213966|SUPERIORITY|||||||0.94|||||||ANOVA|||||||0.94
72345444|NCT01399866|144213967|SUPERIORITY|||||||0.818|||||||ANOVA|||||||0.818
72345445|NCT01399866|144213968|SUPERIORITY|||||||0.123|||||||ANOVA|||||||0.123
72345446|NCT01399866|144213969|SUPERIORITY|||||||0.473|||||||t-test, 2 sided|||||||0.473
72345447|NCT03916081|144213981|SUPERIORITY||LS Mean Difference vs Vehicle|-1.18||||0.356|TWO_SIDED|95.0|-2.983|0.619||MMRM = mixed effects model for repeated measures vIGA-AD = validated Investigator Global Assessment scale for Atopic Dermatitis|MMRM|Change from BL MMRM model includes treatment, visit, vIGA-AD strata, treatment-by-visit interaction as fixed effects and baseline EASI as a covariate.|Change from BL MMRM model includes treatment, visit, vIGA-AD strata, treatment-by-visit interaction as fixed effects and baseline EASI as a covariate.|Change from Baseline in Week 4 EASI Total Score: Roflumilast Cream 0.05% vs. Vehicle Cream||0.619|-2.983|0.356
72345448|NCT03916081|144213981|SUPERIORITY||LS Mean Difference vs Vehicle|-1.6||||0.097|TWO_SIDED|95.0|-3.382|0.178|||MMRM|Change from BL MMRM model includes treatment, visit, vIGA-AD strata, treatment-by-visit interaction as fixed effects and baseline EASI as a covariate.|Change from BL MMRM model includes treatment, visit, vIGA-AD strata, treatment-by-visit interaction as fixed effects and baseline EASI as a covariate.|Change from Baseline in Week 4 EASI Total Score: Roflumilast Cream 0.15% vs. Vehicle Cream||0.178|-3.382|0.097
72345449|NCT03916081|144213982|SUPERIORITY||LS Mean Difference|-11.37||||0.248|TWO_SIDED|95.0|-26.789|4.044|||MMRM|Change from BL MMRM model includes treatment, visit, vIGA-AD strata, treatment-by-visit interaction as fixed effects and baseline EASI as a covariate.|Change from BL MMRM model includes treatment, visit, vIGA-AD strata, treatment-by-visit interaction as fixed effects and baseline EASI as a covariate.|Percent Change from Baseline in Week 1 EASI Total Score: Roflumilast Cream 0.05% vs. Vehicle Cream||4.044|-26.789|0.248
72428928|NCT03257995|144368744|OTHER||Mean Difference (Final Values)|0.1862|||<|0.001|TWO_SIDED|95.0|0.0882|0.2842|||ANOVA|||23 hours 45 min||0.2842|0.0882|<0.001
72428929|NCT03257995|144368744|OTHER||Mean Difference (Final Values)|0.1956|||<|0.001|TWO_SIDED|95.0|0.1012|0.2899|||ANOVA|||5 min||0.2899|0.1012|<0.001
72345450|NCT03916081|144213982|SUPERIORITY||LS Mean Difference|-10.28||||0.349|TWO_SIDED|95.0|-25.666|5.114|||MMRM|Change from BL MMRM model includes treatment, visit, vIGA-AD strata, treatment-by-visit interaction as fixed effects and baseline EASI as a covariate.|Change from BL MMRM model includes treatment, visit, vIGA-AD strata, treatment-by-visit interaction as fixed effects and baseline EASI as a covariate.|Percent Change from Baseline in Week 1 EASI Total Score: Roflumilast Cream 0.15% vs. Vehicle Cream||5.114|-25.666|0.349
72345451|NCT03916081|144213982|SUPERIORITY||LS Mean Difference|-5.82||||0.912|TWO_SIDED|-22.52|-22.52|10.88|||MMRM|Change from BL MMRM model includes treatment, visit, vIGA-AD strata, treatment-by-visit interaction as fixed effects and baseline EASI as a covariate.|Change from BL MMRM model includes treatment, visit, vIGA-AD strata, treatment-by-visit interaction as fixed effects and baseline EASI as a covariate.|Percent Change from Baseline in Week 2 EASI Total Score: Roflumilast Cream 0.05% vs. Vehicle Cream||10.880|-22.520|0.912
72345452|NCT03916081|144213982|SUPERIORITY||LS Mean Difference|-9.17||||0.548|TWO_SIDED|95.0|-25.686|7.341|||MMRM|Change from BL MMRM model includes treatment, visit, vIGA-AD strata, treatment-by-visit interaction as fixed effects and baseline EASI as a covariate.|Change from BL MMRM model includes treatment, visit, vIGA-AD strata, treatment-by-visit interaction as fixed effects and baseline EASI as a covariate.|Percent Change from Baseline in Week 2 EASI Total Score: Roflumilast Cream 0.15% vs. Vehicle Cream||7.341|-25.686|0.548
72345453|NCT03916081|144213982|SUPERIORITY||LS Mean Difference|-13.53||||0.164|TWO_SIDED|95.0|-30.157|3.097|||MMRM|Change from BL MMRM model includes treatment, visit, vIGA-AD strata, treatment-by-visit interaction as fixed effects and baseline EASI as a covariate.|Change from BL MMRM model includes treatment, visit, vIGA-AD strata, treatment-by-visit interaction as fixed effects and baseline EASI as a covariate.|Percent Change from Baseline in Week 4 EASI Total Score: Roflumilast Cream 0.05% vs. Vehicle Cream||3.097|-30.157|0.164
72345454|NCT03916081|144213982|SUPERIORITY||LS Mean Difference|-16.48||||0.049|TWO_SIDED|95.0|-32.921|-0.048|||MMRM|Change from BL MMRM model includes treatment, visit, vIGA-AD strata, treatment-by-visit interaction as fixed effects and baseline EASI as a covariate.|Change from BL MMRM model includes treatment, visit, vIGA-AD strata, treatment-by-visit interaction as fixed effects and baseline EASI as a covariate.|Percent Change from Baseline in Week 4 EASI Total Score: Roflumilast Cream 0.15% vs. Vehicle Cream||-0.048|-32.921|0.049
72345455|NCT03916081|144213983|SUPERIORITY||LS Mean Difference|-0.92||||0.44|TWO_SIDED|95.0|-2.412|0.568|||MMRM|Change from BL MMRM model includes treatment, visit, vIGA-AD strata, treatment-by-visit interaction as fixed effects and baseline EASI as a covariate.|Change from BL MMRM model includes treatment, visit, vIGA-AD strata, treatment-by-visit interaction as fixed effects and baseline EASI as a covariate.|Change from Baseline in Week 1 EASI Total Score: Roflumilast Cream 0.05% vs. Vehicle Cream||0.568|-2.412|0.440
72345456|NCT03916081|144213983|SUPERIORITY||LS Mean Difference|-0.57||||0.875|TWO_SIDED|95.0|-2.061|0.914|||MMRM|Change from BL MMRM model includes treatment, visit, vIGA-AD strata, treatment-by-visit interaction as fixed effects and baseline EASI as a covariate.|Change from BL MMRM model includes treatment, visit, vIGA-AD strata, treatment-by-visit interaction as fixed effects and baseline EASI as a covariate.|Change from Baseline in Week 1 EASI Total Score: Roflumilast Cream 0.15% vs. Vehicle Cream||0.914|-2.061|0.875
72345457|NCT03916081|144213984|SUPERIORITY|||||||0.352|||||||Cochran-Mantel-Haenszel|Baseline vIGA-AD was included as stratification factor.||Number Achieving EASI-50 at Week 1: Roflumilast Cream 0.05% vs. Vehicle Cream||||0.352
72345458|NCT03916081|144213984|SUPERIORITY|||||||0.803|||||||Cochran-Mantel-Haenszel|Baseline vIGA-AD was included as stratification factor.||Number Achieving EASI-50 at Week 1: Roflumilast Cream 0.15% vs. Vehicle Cream||||0.803
72345459|NCT03916081|144213984|SUPERIORITY|||||||0.25|||||||Cochran-Mantel-Haenszel|Baseline vIGA-AD was included as stratification factor.||Number Achieving EASI-50 at Week 2: Roflumilast Cream 0.05% vs. Vehicle Cream||||0.250
72345460|NCT03916081|144213984|SUPERIORITY|||||||0.756|||||||Cochran-Mantel-Haenszel|Baseline vIGA-AD was included as stratification factor.||Number Achieving EASI-50 at Week 2: Roflumilast Cream 0.15% vs. Vehicle Cream||||0.756
72345461|NCT03916081|144213984|SUPERIORITY|||||||0.097|||||||Cochran-Mantel-Haenszel|Baseline vIGA-AD was included as stratification factor.||Number Achieving EASI-50 at Week 4: Roflumilast Cream 0.05% vs. Vehicle Cream||||0.097
72345462|NCT03916081|144213984|SUPERIORITY|||||||0.054|||||||Cochran-Mantel-Haenszel|Baseline vIGA-AD was included as stratification factor.||Number Achieving EASI-50 at Week 4: Roflumilast Cream 0.15% vs. Vehicle Cream||||0.054
72345463|NCT03916081|144213985|SUPERIORITY|||||||0.178|||||||Cochran-Mantel-Haenszel|Baseline vIGA-AD was included as stratification factor.||Number Achieving EASI-75 at Week 1: Roflumilast Cream 0.05% vs. Vehicle Cream||||0.178
72345464|NCT03916081|144213985|SUPERIORITY|||||||0.046|||||||Cochran-Mantel-Haenszel|Baseline vIGA-AD was included as stratification factor.||Number Achieving EASI-75 at Week 1: Roflumilast Cream 0.15% vs. Vehicle Cream||||0.046
72345465|NCT03916081|144213985|SUPERIORITY|||||||0.469|||||||Cochran-Mantel-Haenszel|Baseline vIGA-AD was included as stratification factor.||Number Achieving EASI-75 at Week 2: Roflumilast Cream 0.05% vs. Vehicle Cream||||0.469
72345466|NCT03916081|144213985|SUPERIORITY|||||||0.446|||||||Cochran-Mantel-Haenszel|Baseline vIGA-AD was included as stratification factor.||Number Achieving EASI-75 at Week 2: Roflumilast Cream 0.15% vs. Vehicle Cream||||0.446
72345467|NCT03916081|144213985|SUPERIORITY|||||||0.009|||||||Cochran-Mantel-Haenszel|Baseline vIGA-AD was included as stratification factor.||Number Achieving EASI-75 at Week 4: Roflumilast Cream 0.05% vs. Vehicle Cream||||0.009
72345468|NCT03916081|144213985|SUPERIORITY|||||||0.045|||||||Cochran-Mantel-Haenszel|Baseline vIGA-AD was included as stratification factor.||Number Achieving EASI-75 at Week 4: Roflumilast Cream 0.15% vs. Vehicle Cream||||0.045
72345469|NCT03916081|144213986|SUPERIORITY|||||||0.317|||||||Cochran-Mantel-Haenszel|Baseline vIGA-AD was included as stratification factor.||Number Achieving EASI-90 at Week 1: Roflumilast Cream 0.15% vs. Vehicle Cream||||0.317
72345470|NCT03916081|144213986|SUPERIORITY|||||||0.182|||||||Cochran-Mantel-Haenszel|Baseline vIGA-AD was included as stratification factor.||Number Achieving EASI-90 at Week 2: Roflumilast Cream 0.05% vs. Vehicle Cream||||0.182
72428930|NCT03257995|144368744|OTHER||Mean Difference (Final Values)|0.2927|||<|0.001|TWO_SIDED|95.0|0.1979|0.3875|||ANOVA|||15 min||0.3875|0.1979|<0.001
72428931|NCT03257995|144368744|OTHER||Mean Difference (Final Values)|0.2723|||<|0.001|TWO_SIDED|95.0|0.178|0.3667|||ANOVA|||30 min||0.3667|0.1780|<0.001
72428932|NCT03257995|144368744|OTHER||Mean Difference (Final Values)|0.2386|||<|0.001|TWO_SIDED|95.0|0.1445|0.3328|||ANOVA|||1 hour||0.3328|0.1445|<0.001
72345471|NCT03916081|144213986|SUPERIORITY|||||||0.485|||||||Cochran-Mantel-Haenszel|Baseline vIGA-AD was included as stratification factor.||Number Achieving EASI-90 at Week 2: Roflumilast Cream 0.15% vs. Vehicle Cream||||0.485
72345472|NCT03916081|144213986|SUPERIORITY|||||||0.913|||||||Cochran-Mantel-Haenszel|Baseline vIGA-AD was included as stratification factor.||Number Achieving EASI-90 at Week 4: Roflumilast Cream 0.05% vs. Vehicle Cream||||0.913
72345473|NCT03916081|144213986|SUPERIORITY|||||||0.288|||||||Cochran-Mantel-Haenszel|Baseline vIGA-AD was included as stratification factor.||Number Achieving EASI-90 at Week 4: Roflumilast Cream 0.05% vs. Vehicle Cream||||0.288
72345474|NCT03916081|144213987|SUPERIORITY|||||||0.34|||||||Cochran-Mantel-Haenszel|Baseline vIGA-AD was included as stratification factor.||Number Achieving EASI-100 at Week 2: Roflumilast Cream 0.05% vs. Vehicle Cream||||0.340
72345475|NCT03916081|144213987|SUPERIORITY|||||||0.146|||||||Cochran-Mantel-Haenszel|Baseline vIGA-AD was included as stratification factor.||Number Achieving EASI-100 at Week 2: Roflumilast Cream 0.15% vs. Vehicle Cream||||0.146
72345476|NCT03916081|144213987|SUPERIORITY|||||||0.967|||||||Cochran-Mantel-Haenszel|Baseline vIGA-AD was included as stratification factor.||Number Achieving EASI-100 at Week 4: Roflumilast Cream 0.05% vs. Vehicle Cream||||0.967
72345477|NCT03916081|144213987|SUPERIORITY|||||||0.088|||||||Cochran-Mantel-Haenszel|Baseline vIGA-AD was included as stratification factor.||Number Achieving EASI-100 at Week 4: Roflumilast Cream 0.15% vs. Vehicle Cream||||0.088
72345478|NCT03916081|144213988|SUPERIORITY||LS Mean Difference|0.38||||0.989|TWO_SIDED|95.0|-1.098|1.852|||MMRM|Dunnett's method was used to control for multiple comparisons|Change from BL MMRM model includes treatment, visit, vIGA-AD strata, treatment-by-visit interaction as fixed effects and baseline BSA as a covariate.|Change from Baseline in BSA Affected at Week 1: Roflumilast Cream 0.05% vs. Vehicle Cream||1.852|-1.098|0.989
72345479|NCT03916081|144213988|SUPERIORITY||LS Mean Difference|-0.1|||>|0.999|TWO_SIDED|95.0|-1.566|1.367|||MMRM|Dunnett's method was used to control for multiple comparisons|Change from BL MMRM model includes treatment, visit, vIGA-AD strata, treatment-by-visit interaction as fixed effects and baseline BSA as a covariate.|Change from Baseline in BSA Affected at Week 1: Roflumilast Cream 0.15% vs. Vehicle Cream||1.367|-1.566|>0.999
72428933|NCT03257995|144368744|OTHER||Mean Difference (Final Values)|0.2986|||<|0.001|TWO_SIDED|95.0|0.2042|0.393|||ANOVA|||2 hours||0.3930|0.2042|<0.001
72345480|NCT03916081|144213988|SUPERIORITY||LS Mean Difference|0.6||||0.966|TWO_SIDED|95.0|-1.51|2.702|||MMRM|Dunnett's method was used to control for multiple comparisons|Change from BL MMRM model includes treatment, visit, vIGA-AD strata, treatment-by-visit interaction as fixed effects and baseline BSA as a covariate.|Change from Baseline in BSA Affected at Week 2: Roflumilast Cream 0.05% vs. Vehicle Cream||2.702|-1.510|0.966
72345481|NCT03916081|144213988|SUPERIORITY||LS Mean Difference|-0.34||||0.999|TWO_SIDED|95.0|-2.415|1.744|||MMRM|Dunnett's method was used to control for multiple comparisons|Change from BL MMRM model includes treatment, visit, vIGA-AD strata, treatment-by-visit interaction as fixed effects and baseline BSA as a covariate.|Change from Baseline in BSA Affected at Week 2: Roflumilast Cream 0.15% vs. Vehicle Cream||1.744|-2.415|0.999
72345482|NCT03916081|144213988|SUPERIORITY||LS Mean Difference|-0.25|||>|0.999|TWO_SIDED|95.0|-2.624|2.119|||MMRM|Dunnett's method was used to control for multiple comparisons|Change from BL MMRM model includes treatment, visit, vIGA-AD strata, treatment-by-visit interaction as fixed effects and baseline BSA as a covariate.|Change from Baseline in BSA Affected at Week 4: Roflumilast Cream 0.05% vs. Vehicle Cream||2.119|-2.624|>0.999
72345483|NCT03916081|144213988|SUPERIORITY||LS Mean Difference|-0.94||||0.798|TWO_SIDED|95.0|-3.285|1.398|||MMRM|Dunnett's method was used to control for multiple comparisons|Change from BL MMRM model includes treatment, visit, vIGA-AD strata, treatment-by-visit interaction as fixed effects and baseline BSA as a covariate.|Change from Baseline in BSA Affected at Week 4: Roflumilast Cream 0.15% vs. Vehicle Cream||1.398|-3.285|0.798
72345484|NCT03916081|144213989|SUPERIORITY||LS Mean Difference|-0.78||||0.466|TWO_SIDED|95.0|-2.075|0.506|||MMRM|Dunnett's method was used to control for multiple comparisons|Change from BL MMRM model includes treatment, visit, vIGA-AD strata, treatment-by-visit interaction as fixed effects and baseline WI-NRS as a covariate.|Change from Baseline in WI-NRS at Week 1: Roflumilast Cream 0.05% vs. Vehicle Cream||0.506|-2.075|0.466
72345485|NCT03916081|144213989|SUPERIORITY||LS Mean Difference|-1.03||||0.18|TWO_SIDED|95.0|-2.322|0.255|||MMRM|Dunnett's method was used to control for multiple comparisons|Change from BL MMRM model includes treatment, visit, vIGA-AD strata, treatment-by-visit interaction as fixed effects and baseline WI-NRS as a covariate.|Change from Baseline in WI-NRS at Week 1: Roflumilast Cream 0.15% vs. Vehicle Cream||0.255|-2.322|0.180
72345486|NCT03916081|144213989|SUPERIORITY||LS Mean Difference|-0.43||||0.967|TWO_SIDED|95.0|-1.921|1.069|||MMRM|Dunnett's method was used to control for multiple comparisons|Change from BL MMRM model includes treatment, visit, vIGA-AD strata, treatment-by-visit interaction as fixed effects and baseline WI-NRS as a covariate.|Change from Baseline in WI-NRS at Week 2: Roflumilast Cream 0.05% vs. Vehicle Cream||1.069|-1.921|0.967
72345487|NCT03916081|144213989|SUPERIORITY||LS Mean Difference|-0.72||||0.684|TWO_SIDED|95.0|-2.205|0.762|||MMRM|Dunnett's method was used to control for multiple comparisons|Change from BL MMRM model includes treatment, visit, vIGA-AD strata, treatment-by-visit interaction as fixed effects and baseline WI-NRS as a covariate.|Change from Baseline in WI-NRS at Week 2: Roflumilast Cream 0.15% vs. Vehicle Cream||0.762|-2.205|0.684
72345488|NCT03916081|144213989|SUPERIORITY||LS Mean Difference|-0.61||||0.856|TWO_SIDED|95.0|-2.221|1.003|||MMRM|Dunnett's method was used to control for multiple comparisons|Change from BL MMRM model includes treatment, visit, vIGA-AD strata, treatment-by-visit interaction as fixed effects and baseline WI-NRS as a covariate.|Change from Baseline in WI-NRS at Week 4: Roflumilast Cream 0.05% vs. Vehicle Cream||1.003|-2.221|0.856
72428934|NCT03257995|144368744|OTHER||Mean Difference (Final Values)|0.2661|||<|0.001|TWO_SIDED|95.0|0.1715|0.3607|||ANOVA|||4 hours||0.3607|0.1715|<0.001
72428935|NCT03257995|144368744|OTHER||Mean Difference (Final Values)|0.2558|||<|0.001|TWO_SIDED|95.0|0.1609|0.3506|||ANOVA|||8 hours||0.3506|0.1609|<0.001
72428936|NCT03257995|144368744|OTHER||Mean Difference (Final Values)|0.1987|||<|0.001|TWO_SIDED|95.0|0.1036|0.2938|||ANOVA|||12 hours||0.2938|0.1036|<0.001
72428937|NCT03257995|144368744|OTHER||Mean Difference (Final Values)|0.2044|||<|0.001|TWO_SIDED|95.0|0.1071|0.3017|||ANOVA|||23 hours 15 min||0.3017|0.1071|<0.001
72428938|NCT03257995|144368744|OTHER||Mean Difference (Final Values)|0.1997|||<|0.001|TWO_SIDED|95.0|0.1023|0.297|||ANOVA|||23 hours 45 min||0.2970|0.1023|<0.001
72428939|NCT03257995|144368745|OTHER||Mean Difference (Final Values)|0.2476|||<|0.001|TWO_SIDED|95.0|0.1857|0.3095|||ANOVA|||||0.3095|0.1857|<.001
72345489|NCT03916081|144213989|SUPERIORITY||LS Mean Difference|-0.51||||0.932|TWO_SIDED|95.0|-2.105|1.089|||MMRM|Dunnett's method was used to control for multiple comparisons|Change from BL MMRM model includes treatment, visit, vIGA-AD strata, treatment-by-visit interaction as fixed effects and baseline WI-NRS as a covariate.|Change from Baseline in WI-NRS at Week 4: Roflumilast Cream 0.15% vs. Vehicle Cream||1.089|-2.105|0.932
72345490|NCT03916081|144213990|SUPERIORITY|||||||0.637|||||||Cochran-Mantel-Haenszel|v-IGA-AD included as a stratification factor.||Number of Participants Achieving a ≥4-Point Improvement from Baseline WI-NRS at Week 1: Roflumilast Cream 0.05% vs. Vehicle Cream||||0.637
72345491|NCT03916081|144213990|SUPERIORITY|||||||0.124|||||||Cochran-Mantel-Haenszel|v-IGA-AD included as a stratification factor.||Number of Participants Achieving a ≥4-Point Improvement from Baseline WI-NRS at Week 1: Roflumilast Cream 0.05% vs. Vehicle Cream||||0.124
72345492|NCT03916081|144213990|SUPERIORITY|||||||0.196|||||||Cochran-Mantel-Haenszel|v-IGA-AD included as a stratification factor.||Number of Participants Achieving a ≥4-Point Improvement from Baseline WI-NRS at Week 2: Roflumilast Cream 0.05% vs. Vehicle Cream||||0.196
72345493|NCT03916081|144213990|SUPERIORITY|||||||0.985|||||||Cochran-Mantel-Haenszel|v-IGA-AD included as a stratification factor.||Number of Participants Achieving a ≥4-Point Improvement from Baseline WI-NRS at Week 2: Roflumilast Cream 0.05% vs. Vehicle Cream||||0.985
72345494|NCT03916081|144213990|SUPERIORITY|||||||0.401|||||||Cochran-Mantel-Haenszel|v-IGA-AD included as a stratification factor.||Number of Participants Achieving a ≥4-Point Improvement from Baseline WI-NRS at Week 4: Roflumilast Cream 0.05% vs. Vehicle Cream||||0.401
72345495|NCT03916081|144213990|SUPERIORITY|||||||0.996|||||||Cochran-Mantel-Haenszel|v-IGA-AD included as a stratification factor.||Number of Participants Achieving a ≥4-Point Improvement from Baseline WI-NRS at Week 4: Roflumilast Cream 0.15% vs. Vehicle Cream||||0.996
72345496|NCT03368235|144213994|OTHER||LS mean difference|0.472|STANDARD_ERROR_OF_MEAN|0.4569||0.315|TWO_SIDED|95.0|-0.487|1.431||Based on MMRM model with the baseline DAS28-CRP score as a continuous covariate and country, visit and treatment group as categorical fixed effects, as well as visit interaction with treatment group, using unstructured covariance matrix.|MMRM|||MMRM = mixed model repeated measures.||1.431|-0.487|0.315
72345497|NCT03368235|144213995|OTHER||Odds Ratio (OR)|0.807||||0.807|TWO_SIDED|95.0|0.12|5.34||Logistic regression model with the treatment group, country and baseline DAS28-CRP as covariate.|Regression, Logistic|||Treatment comparison ACR20: AZD9567 Vs prednisolone||5.34|0.12|0.807
72345498|NCT03368235|144213995|OTHER|||||||0.198|||||||Fisher Exact|||Treatment comparison ACR50: AZD9567 Vs prednisolone||||0.198
72345499|NCT03368235|144213995|OTHER|||||||0.183|||||||Fisher Exact|||Treatment comparison ACR70: AZD9567 Vs prednisolone||||0.183
72345500|NCT03368235|144213996|OTHER||LS mean difference|0.42|STANDARD_ERROR_OF_MEAN|1.136||0.717|TWO_SIDED|95.0|-1.98|2.81||The MMRM with the baseline SJC66 score as a continuous covariate and country, visit and treatment group as categorical fixed effects, as well as visit interaction with treatment group, using unstructured covariance matrix.|MMRM|||||2.81|-1.98|0.717
72345501|NCT03368235|144213997|OTHER||LS mean difference|-1.12|STANDARD_ERROR_OF_MEAN|3.115||0.724|TWO_SIDED|95.0|-7.69|5.46||The MMRM with the baseline TJC68 score as a continuous covariate and country, visit and treatment group as categorical fixed effects, as well as visit interaction with treatment group, using unstructured covariance matrix.|MMRM|||||5.46|-7.69|0.724
72345502|NCT03368235|144213998|OTHER||LS mean difference|-0.05|STANDARD_ERROR_OF_MEAN|1.6||0.973|TWO_SIDED|95.0|-3.43|3.32||The MMRM with the baseline TJC28 score as a continuous covariate and country, visit and treatment group as categorical fixed effects, as well as visit interaction with treatment group, using unstructured covariance matrix.|MMRM|||||3.32|-3.43|0.973
72345503|NCT03368235|144213999|OTHER||LS mean difference|0.26|STANDARD_ERROR_OF_MEAN|0.837||0.757|TWO_SIDED|95.0|-1.5|2.03||The MMRM with the baseline SJC28 score as a continuous covariate and country, visit and treatment group as categorical fixed effects, as well as visit interaction with treatment group, using unstructured covariance matrix.|MMRM|||||2.03|-1.50|0.757
72428940|NCT03257995|144368745|OTHER||Mean Difference (Final Values)|0.2448|||<|0.001|TWO_SIDED|95.0|0.183|0.3066|||ANOVA|||||0.3066|0.1830|<.001
72345504|NCT03368235|144214000|OTHER||LS mean difference|9.8|STANDARD_ERROR_OF_MEAN|9.67||0.325|TWO_SIDED|95.0|-10.5|30.1||The MMRM with the baseline GH score as a continuous covariate and country, visit and treatment group as categorical fixed effects, as well as visit interaction with treatment group, using unstructured covariance matrix.|MMRM|||||30.1|-10.5|0.325
72345505|NCT03368235|144214001|OTHER||LS mean difference|4.756|STANDARD_ERROR_OF_MEAN|3.4725||0.187|TWO_SIDED|95.0|-2.514|12.025||The MMRM with the baseline CRP score as a continuous covariate and country, visit and treatment group as categorical fixed effects, as well as visit interaction with treatment group, using unstructured covariance matrix.|MMRM|||||12.025|-2.514|0.187
72345506|NCT03368235|144214002|OTHER||LS mean difference|16.0|STANDARD_ERROR_OF_MEAN|10.49||0.144|TWO_SIDED|95.0|-6.0|38.1||The MMRM with the baseline participant's assessment of pain score as a continuous covariate and country, visit and treatment group as categorical fixed effects, as well as visit interaction with treatment group, using unstructured covariance matrix.|MMRM|||||38.1|-6.0|0.144
72345507|NCT03368235|144214003|OTHER||LS mean difference|3.8|STANDARD_ERROR_OF_MEAN|5.73||0.512|TWO_SIDED|95.0|-8.3|16.0||The MMRM with the baseline disease activity score as a continuous covariate and country, visit and treatment group as categorical fixed effects, as well as visit interaction with treatment group, using unstructured covariance matrix.|MMRM|||||16.0|-8.3|0.512
72345508|NCT03368235|144214004|OTHER||LS mean difference|0.131|STANDARD_ERROR_OF_MEAN|0.2381||0.589|TWO_SIDED|95.0|-0.37|0.631||The MMRM with the baseline physical function score as a continuous covariate and country, visit and treatment group as categorical fixed effects, as well as visit interaction with treatment group, using unstructured covariance matrix.|MMRM|||||0.631|-0.370|0.589
72345509|NCT02828020|144214010|SUPERIORITY||Odds Ratio (OR)|1.83||||0.0023|TWO_SIDED|95.0|1.25|2.66||P-value was adjusted for multiple comparisons across primary and secondary endpoints and multiple doses.|Regression, Logistic|Treatment group, historical triptan response, medication use for migraine prevention, baseline headache severity were explanatory variables in model.||||2.66|1.25|0.0023
72428941|NCT03257995|144368745|OTHER||Mean Difference (Net)|-0.0028|||||TWO_SIDED|95.0|-0.0647|0.059|||ANOVA|||||0.0590|-0.0647|
72428942|NCT03257995|144368746|OTHER||Mean Difference (Final Values)|-0.42||||0.009|TWO_SIDED|95.0|-0.73|0.11|||ANOVA|||||0.11|-0.73|0.009
72428943|NCT03257995|144368746|OTHER||Mean Difference (Final Values)|-0.42||||0.008|TWO_SIDED|95.0|-0.73|0.11|||ANOVA|||||0.11|-0.73|0.008
72345510|NCT02828020|144214010|SUPERIORITY||Odds Ratio (OR)|2.04||||0.0003|TWO_SIDED|95.0|1.41|2.95||P-value was adjusted for multiple comparisons across primary and secondary endpoints and multiple doses.|Regression, Logistic|Treatment group, historical triptan response, medication use for migraine prevention, baseline headache severity were explanatory variables in model.||||2.95|1.41|0.0003
72345511|NCT02828020|144214011|SUPERIORITY||Odds Ratio (OR)|1.7||||0.0023|TWO_SIDED|95.0|1.27|2.28||P-value was adjusted for multiple comparisons across primary and secondary endpoints and multiple doses.|Regression, Logistic|Treatment group, historical triptan response, migraine prevention medication, baseline headache severity, underlying symptom as explanatory variables.||||2.28|1.27|0.0023
72345512|NCT02828020|144214011|SUPERIORITY||Odds Ratio (OR)|1.63||||0.0023|TWO_SIDED|95.0|1.22|2.17||P-value was adjusted for multiple comparisons across primary and secondary endpoints and multiple doses.|Regression, Logistic|Treatment group, historical triptan response, migraine prevention medication, baseline headache severity, underlying symptom as explanatory variables.||||2.17|1.22|0.0023
72345513|NCT02828020|144214012|SUPERIORITY||Odds Ratio (OR)|1.69||||0.0023|TWO_SIDED|95.0|1.28|2.23||P-value was adjusted for multiple comparisons across primary and secondary endpoints and multiple doses.|Regression, Logistic|Treatment group, historical triptan response, medication use for migraine prevention, baseline headache severity were explanatory variables in model.||||2.23|1.28|0.0023
72345514|NCT02828020|144214012|SUPERIORITY||Odds Ratio (OR)|1.69||||0.0023|TWO_SIDED|95.0|1.28|2.21||P-value was adjusted for multiple comparisons across primary and secondary endpoints and multiple doses.|Regression, Logistic|Treatment group, historical triptan response, medication use for migraine prevention, baseline headache severity were explanatory variables in model.||||2.21|1.28|0.0023
72345515|NCT02828020|144214013|SUPERIORITY||Odds Ratio (OR)|2.25||||0.0023|TWO_SIDED|95.0|1.65|3.07||P-value was adjusted for multiple comparisons across primary and secondary endpoints and multiple doses.|Regression, Logistic|Treatment group, historical triptan response, medication use for migraine prevention, baseline headache severity were explanatory variables in model.||||3.07|1.65|0.0023
72345516|NCT02828020|144214013|SUPERIORITY||Odds Ratio (OR)|2.39||||0.0023|TWO_SIDED|95.0|1.77|3.24||P-value was adjusted for multiple comparisons across primary and secondary endpoints and multiple doses.|Regression, Logistic|Treatment group, historical triptan response, medication use for migraine prevention, baseline headache severity were explanatory variables in model.||||3.24|1.77|0.0023
72345517|NCT02828020|144214014|SUPERIORITY||Odds Ratio (OR)|1.57||||0.0577|TWO_SIDED|95.0|1.01|2.44||P-value was adjusted for multiple comparisons across primary and secondary endpoints and multiple doses.|Regression, Logistic|Treatment group, historical triptan response, medication use for migraine prevention, baseline headache severity were explanatory variables in model.||||2.44|1.01|0.0577
72345518|NCT02828020|144214014|SUPERIORITY||Odds Ratio (OR)|1.95||||0.0037|TWO_SIDED|95.0|1.28|2.97||P-value was adjusted for multiple comparisons across primary and secondary endpoints and multiple doses.|Regression, Logistic|Treatment group, historical triptan response, medication use for migraine prevention, baseline headache severity were explanatory variables in model.||||2.97|1.28|0.0037
72345519|NCT02828020|144214015|SUPERIORITY||Odds Ratio (OR)|1.63||||0.0577|TWO_SIDED|95.0|1.22|2.19||P-value was adjusted for multiple comparisons across primary and secondary endpoints and multiple doses.|Regression, Logistic|Treatment group, historical triptan response, migraine prevention medication, baseline headache severity, photophobia were explanatory variables.||||2.19|1.22|0.0577
72345520|NCT02828020|144214015|SUPERIORITY||Odds Ratio (OR)|1.81||||0.0037|TWO_SIDED|95.0|1.36|2.42||P-value was adjusted for multiple comparisons across primary and secondary endpoints and multiple doses.|Regression, Logistic|Treatment group, historical triptan response, migraine prevention medication, baseline headache severity, photophobia were explanatory variables.||||2.42|1.36|0.0037
72345521|NCT02828020|144214016|SUPERIORITY||Odds Ratio (OR)|1.56||||0.0577|TWO_SIDED|95.0|1.16|2.09||P-value was adjusted for multiple comparisons across primary and secondary endpoints and multiple doses.|Regression, Logistic|Treatment group, historical triptan response, migraine prevention medication, baseline headache severity, phonophobia were explanatory variables.||||2.09|1.16|0.0577
72345522|NCT02828020|144214016|SUPERIORITY||Odds Ratio (OR)|1.47||||0.0577|TWO_SIDED|95.0|1.1|1.95||P-value was adjusted for multiple comparisons across primary and secondary endpoints and multiple doses.|Regression, Logistic|Treatment group, historical triptan response, migraine prevention medication, baseline headache severity, phonophobia were explanatory variables.||||1.95|1.10|0.0577
72345523|NCT02828020|144214017|SUPERIORITY||Odds Ratio (OR)|1.31||||0.0962|TWO_SIDED|95.0|0.96|1.79||P-value was adjusted for multiple comparisons across primary and secondary endpoints and multiple doses.|Regression, Logistic|Treatment group, historical triptan response, migraine prevention medication, baseline headache severity, nausea were explanatory variables.||||1.79|0.96|0.0962
72345524|NCT02828020|144214017|SUPERIORITY||Odds Ratio (OR)|1.35||||0.0962|TWO_SIDED|95.0|1.0|1.83||P-value was adjusted for multiple comparisons across primary and secondary endpoints and multiple doses.|Regression, Logistic|Treatment group, historical triptan response, migraine prevention medication, baseline headache severity, nausea were explanatory variables.||||1.83|1.00|0.0962
72345525|NCT00847197|144214026|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|2.1||0.926|TWO_SIDED|95.0|-3.9|4.3||The significance test was 2-tailed with α=0.05.|Mixed Models Analysis|The test for the treatment difference in terms of percentage change from baseline to a given time point was done using the contrast statement.||For the analysis of percent change from baseline in LDL-C at study endpoint, a Longitudinal Analysis of Covariance (ANCOVA) method was used. The repeated measures model included terms for treatment, time (Day 15, 29), and the interaction of time-by-treatment. The analysis model also adjusted for baseline, baseline-by-time interaction, region and gender.||4.3|-3.9|0.926
72345526|NCT00847197|144214027|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.6|STANDARD_ERROR_OF_MEAN|1.8||0.013|TWO_SIDED|95.0|1.0|8.1||The significance test was 2-tailed with α=0.05.|Mixed Models Analysis|The test for the treatment difference in terms of percentage change from baseline to a given time point was done using the contrast statement.||For the analysis of percent change from baseline in LDL-C at study endpoint, a Longitudinal Analysis of Covariance (ANCOVA) method was used. The repeated measures model included terms for treatment, time (Day 15, 29), and the interaction of time-by-treatment. The analysis model also adjusted for baseline, baseline-by-time interaction, region and gender.||8.1|1.0|0.013
72428944|NCT03257995|144368747|OTHER||Mean Difference (Final Values)|33.0|||<|0.001|TWO_SIDED|95.0|25.6|40.3|||ANOVA|||||40.3|25.6|<0.001
72428945|NCT03257995|144368747|OTHER||Mean Difference (Final Values)|30.8|||<|0.001|TWO_SIDED|95.0|23.5|38.2|||ANOVA|||||38.2|23.5|<0.001
72428946|NCT01556763|144368766|SUPERIORITY_OR_OTHER||||||=|0.1||95.0|||||ANCOVA|||Baseline value was the covariate and all values obtained during the treatment period were averaged together. This value was adjusted by regression against the baseline and estimation of a new value as if all subjects possessed the same baseline.||||=0.10
72345527|NCT00847197|144214028|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-10.3|STANDARD_ERROR_OF_MEAN|8.6||0.02|TWO_SIDED|95.0|-18.9|-1.9|||Wilcoxon's Rank Sum Test|The significance test was 2-tailed with α=0.05.||Triglycerides was analyzed by non-parametric methods with terms for treatment, gender and region. Specifically, the analysis of variance (ANOVA) model was applied to the Tukey's normal scores of the percent change from baseline. The estimate of the difference in medians between MK1903 and the placebo groups utilizing the Hodges-Lehmann estimate and a distribution-free 95% CI for the difference based on Wilcoxon's rank sum test was provided.||-1.9|-18.9|0.02
72345528|NCT00348309|144214029|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.3||||0.049|TWO_SIDED|95.0|-2.7|0.0||APOE4 negatives|Mixed Models Analysis|||||-0.0|-2.7|0.049
72345529|NCT00348309|144214029|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2||||0.808|TWO_SIDED|95.0|-1.7|1.3||APOE4 negatives|Mixed Models Analysis|||||1.3|-1.7|0.808
72345530|NCT00348309|144214029|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0||||0.035|TWO_SIDED|95.0|-1.9|-0.1||All except E4/E4s|Mixed Models Analysis|||||-0.1|-1.9|0.035
72345531|NCT00348309|144214029|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.999|TWO_SIDED|95.0|-1.0|1.0||All except E4/E4s|Mixed Models Analysis|||||1.0|-1.0|0.999
72345532|NCT00348309|144214029|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0||||0.02|TWO_SIDED|95.0|-1.9|-0.2||Full population|Mixed Models Analysis|||||-0.2|-1.9|0.020
72345533|NCT00348309|144214029|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2||||0.661|TWO_SIDED|95.0|-1.2|0.7||Full population|Mixed Models Analysis|||||0.7|-1.2|0.661
72345534|NCT00348309|144214030|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5|||=|0.056|TWO_SIDED|95.0|-1.0|0.0||APOE4 negatives|Mixed Models Analysis|||||0.0|-1.0|=0.056
72345535|NCT00348309|144214030|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2|||=|0.587|TWO_SIDED|95.0|-0.4|0.7||APOE4 negatives|Mixed Models Analysis|||||0.7|-0.4|=0.587
72345536|NCT00348309|144214030|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5|||=|0.004|TWO_SIDED|95.0|-0.9|-0.2||All except E4/E4s|Mixed Models Analysis|||||-0.2|-0.9|=0.004
72345537|NCT00348309|144214030|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2|||=|0.402|TWO_SIDED|95.0|-0.2|0.6||All except E4/E4s|Mixed Models Analysis|||||0.6|-0.2|=0.402
72345538|NCT00348309|144214030|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5|||=|0.002|TWO_SIDED|95.0|-0.9|-0.2||Full population|Mixed Models Analysis|||||-0.2|-0.9|=0.002
72345539|NCT00348309|144214030|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1|||=|0.478|TWO_SIDED|95.0|-0.2|0.5||Full population|Mixed Models Analysis|||||0.5|-0.2|=0.478
72345540|NCT00348309|144214031|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6|||=|0.34|TWO_SIDED|95.0|-2.0|0.7||Week 8|Mixed Models Analysis|||||0.7|-2.0|=0.340
72345541|NCT00348309|144214031|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.2|||=|0.079|TWO_SIDED|95.0|-2.5|0.1||Week 8|Mixed Models Analysis|||||0.1|-2.5|=0.079
72345542|NCT00348309|144214031|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|||=|0.91|TWO_SIDED|95.0|-1.7|1.5||Week 16|Mixed Models Analysis|||||1.5|-1.7|=0.910
72345543|NCT00348309|144214031|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5||||0.521|TWO_SIDED|95.0|-2.1|1.0||Week 16|Mixed Models Analysis|||||1.0|-2.1|0.521
72345544|NCT00348309|144214031|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.3|||=|0.154|TWO_SIDED|95.0|-0.5|3.0||Week 24|Mixed Models Analysis|||||3.0|-0.5|=0.154
72345545|NCT00348309|144214031|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2|||=|0.836|TWO_SIDED|95.0|-1.6|2.0||Week 24|Mixed Models Analysis|||||2.0|-1.6|=0.836
72345546|NCT00348309|144214031|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.1||||0.061|TWO_SIDED|95.0|-0.1|4.2||Week 48|Mixed Models Analysis|||||4.2|-0.1|0.061
72345547|NCT00348309|144214031|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7|||=|0.566|TWO_SIDED|95.0|-2.9|1.6||Week 48|Mixed Models Analysis|||||1.6|-2.9|=0.566
72345548|NCT00348309|144214032|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|||=|0.414|TWO_SIDED|95.0|-1.3|0.5||Week 8|Mixed Models Analysis|||||0.5|-1.3|=0.414
72345549|NCT00348309|144214032|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.931|TWO_SIDED|95.0|-1.0|1.1||Week 8|Mixed Models Analysis|||||1.1|-1.0|0.931
72345550|NCT00348309|144214032|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4||||0.485|TWO_SIDED|95.0|-1.4|0.7||Week 16|Mixed Models Analysis|||||0.7|-1.4|0.485
72345551|NCT00348309|144214032|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3||||0.55|TWO_SIDED|95.0|-0.8|1.5||Week 16|Mixed Models Analysis|||||1.5|-0.8|0.550
72345552|NCT00348309|144214032|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6||||0.264|TWO_SIDED|95.0|-1.8|0.5||Week 24|Mixed Models Analysis|||||0.5|-1.8|0.264
72345553|NCT00348309|144214032|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2||||0.732|TWO_SIDED|95.0|-1.5|1.0||Week 24|Mixed Models Analysis|||||1.0|-1.5|0.732
72345554|NCT00348309|144214032|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.5||||0.043|TWO_SIDED|95.0|-2.9|0.0||Week 48|Mixed Models Analysis|||||-0.0|-2.9|0.043
72345555|NCT00348309|144214032|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2||||0.814|TWO_SIDED|95.0|-1.4|1.8||Week 48|Mixed Models Analysis|||||1.8|-1.4|0.814
72345556|NCT00348309|144214033|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.87|TWO_SIDED|95.0|-0.5|0.6|||ANCOVA|||||0.6|-0.5|0.870
72345557|NCT00348309|144214033|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.617|TWO_SIDED|95.0|-0.7|0.4|||ANCOVA|||||0.4|-0.7|0.617
72428947|NCT01556763|144368767|SUPERIORITY_OR_OTHER||||||=|0.07||95.0|||||ANCOVA|||Baseline value was the covariate and all values obtained during the treatment period were averaged together. This value was adjusted by regression against the baseline and estimation of a new value as if all subjects possessed the same baseline.||||=0.07
72428948|NCT01556763|144368768|SUPERIORITY_OR_OTHER||||||=|0.02||95.0|||||ANCOVA|||Baseline value was the covariate and all values obtained during the treatment period were averaged together. This value was adjusted by regression against the baseline and estimation of a new value as if all subjects possessed the same baseline.||||=0.02
72345558|NCT00348309|144214034|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.8||||0.789|TWO_SIDED|95.0|-5.2|6.9|||Mixed Models Analysis|||Week 12 Q1||6.9|-5.2|0.789
72345559|NCT00348309|144214034|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.7||||0.643|TWO_SIDED|95.0|-9.0|5.6||Week 12Q1|Mixed Models Analysis|||||5.6|-9.0|0.643
72345560|NCT00348309|144214034|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.3||||0.052|TWO_SIDED|95.0|-14.7|0.1||Week 24 Q1|Mixed Models Analysis|||||0.1|-14.7|0.052
72345561|NCT00348309|144214034|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.7||||0.481|TWO_SIDED|95.0|-14.0|6.6||Week 24 Q1|Mixed Models Analysis|||||6.6|-14.0|0.481
72345562|NCT00348309|144214034|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.2||||0.195|TWO_SIDED|95.0|-15.6|3.2||Week 36 Q1|Mixed Models Analysis|||||3.2|-15.6|0.195
72345563|NCT00348309|144214034|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.1||||0.857|TWO_SIDED|95.0|-12.9|10.7||Week 36 Q1|Mixed Models Analysis|||||10.7|-12.9|0.857
72345564|NCT00348309|144214034|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.6||||0.422|TWO_SIDED|95.0|-15.9|6.7||Week 48 Q1|Mixed Models Analysis|||||6.7|-15.9|0.422
72345565|NCT00348309|144214034|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.6||||0.562|TWO_SIDED|95.0|-15.7|8.6||Week 48 Q1|Mixed Models Analysis|||||8.6|-15.7|0.562
72345566|NCT00348309|144214034|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.8||||0.129|TWO_SIDED|95.0|-2.6|20.2||Week 12 Q2|Mixed Models Analysis|||||20.2|-2.6|0.129
72345567|NCT00348309|144214034|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.9||||0.194|TWO_SIDED|95.0|-4.0|19.9||Week 12 Q2|Mixed Models Analysis|||||19.9|-4.0|0.194
72345568|NCT00348309|144214034|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.3||||0.832|TWO_SIDED|95.0|-10.5|13.1||Week 24 Q2|Mixed Models Analysis|||||13.1|-10.5|0.832
72345569|NCT00348309|144214034|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.1||||0.351|TWO_SIDED|95.0|-6.8|19.1||Week 24 Q2|Mixed Models Analysis|||||19.1|-6.8|0.351
72345570|NCT00348309|144214034|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4||||0.949|TWO_SIDED|95.0|-13.3|12.5||Week 36 Q2|Mixed Models Analysis|||||12.5|-13.3|0.949
72345571|NCT00348309|144214034|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.3||||0.253|TWO_SIDED|95.0|-6.0|22.6||Week 36 Q2|Mixed Models Analysis|||||22.6|-6.0|0.253
72345572|NCT00348309|144214034|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.4||||0.735|TWO_SIDED|95.0|-16.2|11.4||Week 48 Q2|Mixed Models Analysis|||||11.4|-16.2|0.735
72345573|NCT00348309|144214034|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.2||||0.046|TWO_SIDED|95.0|0.3|32.0||Week 48 Q2|Mixed Models Analysis|||||32.0|0.3|0.046
72345574|NCT00348309|144214035|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.914|TWO_SIDED|95.0|-2.3|2.0||Week 12 Thermometer|Mixed Models Analysis|||||2.0|-2.3|0.914
72345575|NCT00348309|144214035|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0||||0.415|TWO_SIDED|95.0|-3.3|1.4||Week 12 Thermometer|Mixed Models Analysis|||||1.4|-3.3|0.415
72345576|NCT00348309|144214035|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.4||||0.063|TWO_SIDED|95.0|-4.9|0.1||Week 36 Thermometer|Mixed Models Analysis|||||0.1|-4.9|0.063
72345577|NCT00348309|144214035|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.9||||0.03|TWO_SIDED|95.0|-5.6|-0.3||Week 36 Thermometer|Mixed Models Analysis|||||-0.3|-5.6|0.030
72345578|NCT00348309|144214035|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.2||||0.392|TWO_SIDED|95.0|-1.5|3.8||Week 48 Thermometer|Mixed Models Analysis|||||3.8|-1.5|0.392
72345579|NCT00348309|144214035|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9||||0.557|TWO_SIDED|95.0|-3.7|2.0||Week 48 Thermometer|Mixed Models Analysis|||||2.0|-3.7|0.557
72345580|NCT00348309|144214035|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01||||0.32|TWO_SIDED|95.0|-0.01|0.03||Week 12 Utility|Mixed Models Analysis|||||0.03|-0.01|0.320
72345581|NCT00348309|144214035|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02||||0.18|TWO_SIDED|95.0|-0.04|0.01||Week 12 Utility|Mixed Models Analysis|||||0.01|-0.04|0.180
72345582|NCT00348309|144214035|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01||||0.498|TWO_SIDED|95.0|-0.02|0.04||Week 36 Utility|Mixed Models Analysis|||||0.04|-0.02|0.498
72345583|NCT00348309|144214035|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.03||||0.081|TWO_SIDED|95.0|-0.06|0.0||Week 36 Utility|Mixed Models Analysis|||||0.00|-0.06|0.081
72345584|NCT00348309|144214035|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.03||||0.077|TWO_SIDED|95.0|0.0|0.06||Week 48 Utility|Mixed Models Analysis|||||0.06|-0.00|0.077
72345585|NCT00348309|144214035|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01||||0.64|TWO_SIDED|95.0|-0.04|0.03||Week 48 Utility|Mixed Models Analysis|||||0.03|-0.04|0.640
72345586|NCT00348309|144214036|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7||||0.105|TWO_SIDED|95.0|-1.6|0.2|||ANCOVA|||||0.2|-1.6|0.105
72345587|NCT00348309|144214036|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3||||0.483|TWO_SIDED|95.0|-1.3|0.6|||ANCOVA|||||0.6|-1.3|0.483
72345588|NCT00348309|144214037|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5||||0.004|TWO_SIDED|95.0|-0.9|-0.2|||ANCOVA|||||-0.2|-0.9|0.004
72345589|NCT00348309|144214037|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||0.554|TWO_SIDED|95.0|-0.3|0.5|||ANCOVA|||||0.5|-0.3|0.554
72345590|NCT00348309|144214038|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.4||||0.292|TWO_SIDED|95.0|-0.3|1.1|||ANCOVA|||||1.1|-0.3|0.292
72345591|NCT00348309|144214038|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.4||||0.297|TWO_SIDED|95.0|-0.3|1.1|||ANCOVA|||||1.1|-0.3|0.297
72345592|NCT00348309|144214039|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.598|TWO_SIDED|95.0|-0.2|0.1|||ANCOVA|||||0.1|-0.2|0.598
72345593|NCT00348309|144214039|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2||||0.073|TWO_SIDED|95.0|-0.4|0.0|||ANCOVA|||||0.0|-0.4|0.073
72345594|NCT00348309|144214040|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.07||||0.006|TWO_SIDED|95.0|0.02|0.12|||ANCOVA|||||0.12|0.02|0.006
72345595|NCT00348309|144214040|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.04||||0.14|TWO_SIDED|95.0|-0.01|0.09|||ANCOVA|||||0.09|-0.01|0.140
72345596|NCT00348309|144214050|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7||||0.027|TWO_SIDED|95.0|-1.2|-0.1||Week 12|Mixed Models Analysis|||||-0.1|-1.2|0.027
72345597|NCT00348309|144214050|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5||||0.091|TWO_SIDED|95.0|-1.1|0.1||Week 12|Mixed Models Analysis|||||0.1|-1.1|0.091
72345598|NCT00348309|144214050|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4||||0.268|TWO_SIDED|95.0|-1.1|0.3||Week 36|Mixed Models Analysis|||||0.3|-1.1|0.268
72345599|NCT00348309|144214050|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4||||0.318|TWO_SIDED|95.0|-1.1|0.4||Week 36|Mixed Models Analysis|||||0.4|-1.1|0.318
72345600|NCT00348309|144214050|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9||||0.03|TWO_SIDED|95.0|-1.6|-0.1||Week 48|Mixed Models Analysis|||||-0.1|-1.6|0.030
72345601|NCT00348309|144214050|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.797|TWO_SIDED|95.0|-0.9|0.7||Week 48|Mixed Models Analysis|||||0.7|-0.9|0.797
72345602|NCT00622388|144214051|SUPERIORITY_OR_OTHER||Response rate|11.0|||||TWO_SIDED|95.0|5.0|20.0|||||Response rate is calculated as the number of responses divided by the number of participants treated, expressed as a percentage.|||20|5|
72345603|NCT01743040|144214066|NON_INFERIORITY|15% equivalency margin against performance of SPECT nuclear stress test OPC. Both sensitivity and specificity were measured and the equivalency margin was set the same for both parameters.The goal was to test the Sensitivity and specificity of CADence as compared to SPECT nuclear stress test OPC. Both were measured and reported in this study. The Sensitivity of CADence was 78% (95% CI 76.1-90.8%) while the specificity was 36% (95% CI 32-39%).||||||0.012|||||||Exact binomial test|||The goal was to test the Sensitivity and specificity of CADence as compared to SPECT nuclear stress test OPC. Both were measured and reported in this study. The Sensitivity of CADence was 78% (95% CI 76.1-90.8%) while the specificity was 36% (95% CI 32-39%).||||0.012
72345604|NCT00223704|144214086|SUPERIORITY_OR_OTHER|||||||0.72||95.0||||This P-value is for the main comparison of receiving any transfusion.|Chi-squared|||||||0.72
72345605|NCT00223704|144214087|SUPERIORITY_OR_OTHER|||||||0.88|TWO_SIDED|95.0|||||Kruskal-Wallis|||||||0.88
72345606|NCT00223704|144214088|SUPERIORITY_OR_OTHER|||||||0.43|TWO_SIDED|95.0|||||Kruskal-Wallis|||||||0.43
72345607|NCT00223704|144214089|SUPERIORITY_OR_OTHER|||||||0.92||95.0||||The P-value reflects the difference in Interleukin-6 concentrations among the 3 treatment groups over the course of the study (baseline, post-bypass, postoperative day 1 and 2)|Mixed Models Analysis|||The time course for Interleukin-6 concentrations were analyzed using mixed-effects models with fixed effects of drug treatment (placebo, aminocaproic acid, HOE 140) and time since randomization. We included a random subject effect and a first-order autoregressive process to account for the correlation in the response variable in the mixed-effects model||||0.92
72345608|NCT00223704|144214090|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The P-value reflects the difference in D-dimer concentrations among the 3 treatment groups over the course of the study (baseline, 30min, 60min, post-bypass, and postoperative day 1)|Mixed Models Analysis|||The time course for D-dimer concentrations were analyzed using mixed-effects models with fixed effects of drug treatment (placebo, aminocaproic acid, HOE 140) and time since randomization. We included a random subject effect and a first-order autoregressive process to account for the correlation in the response variable in the mixed-effects model||||<0.001
72345609|NCT01990612|144214109|SUPERIORITY||Risk Ratio (RR)|0.8||||0.049|TWO_SIDED|95.0|0.64|1.0|||Chi-squared|Group sequential method to control type I error w/ Lan-DeMets characterization of O'Brien-Fleming boundary. 2-tailed p-value \<0.46 considered stat sig|One interim analysis was performed; in final analysis of the primary outcome, a two-tailed P value of less than 0.046 considered to indicate statistical significance. Since adjustment is minimal, we report 95% confidence interval for relative risk.|||1.00|0.64|0.049
72345610|NCT01990612|144214110|SUPERIORITY||Risk Ratio (RR)|0.66|||||TWO_SIDED|95.0|0.12|3.33|||||Exact confidence intervals are provided for rare outcomes. Widths of the confidence intervals for components of the primary outcome have not been adjusted for multiplicity, and should not be used to infer definitive effects of management strategies.|||3.33|0.12|
72345611|NCT01990612|144214111|SUPERIORITY||Risk Ratio (RR)|0.71|||||TWO_SIDED|95.0|0.55|0.93||||||||0.93|0.55|
72345612|NCT01990612|144214112|SUPERIORITY||Risk Ratio (RR)|0.66|||||TWO_SIDED|95.0|0.32|1.37|||||Widths of the confidence intervals for components of the primary outcome have not been adjusted for multiplicity, and should not be used to infer definitive effects of management strategies.|||1.37|0.32|
72345613|NCT01990612|144214113|SUPERIORITY||Risk Ratio (RR)|0.7|||||TWO_SIDED|95.0|0.35|1.37|||||Widths of the confidence intervals for components of the primary outcome have not been adjusted for multiplicity, and should not be used to infer definitive effects of management strategies.|||1.37|0.35|
72345614|NCT01990612|144214114|SUPERIORITY||Risk Ratio (RR)|2.74|||||TWO_SIDED|95.0|0.91|8.12|||||Exact confidence intervals are provided for rare outcomes. Widths of the confidence intervals for components of the primary outcome have not been adjusted for multiplicity, and should not be used to infer definitive effects of management strategies.|||8.12|0.91|
72345615|NCT01990612|144214115|SUPERIORITY||Risk Ratio (RR)|0.74|||||TWO_SIDED|95.0|0.31|1.76|||||Widths of the confidence intervals for components of the primary outcome have not been adjusted for multiplicity, and should not be used to infer definitive effects of management strategies.|||1.76|0.31|
72345616|NCT01990612|144214116|SUPERIORITY||Risk Ratio (RR)|0.65|||||TWO_SIDED|95.0|0.35|1.19|||||Widths of the confidence intervals for components of the primary outcome have not been adjusted for multiplicity, and should not be used to infer definitive effects of management strategies.|||1.19|0.35|
72345617|NCT01990612|144214117|SUPERIORITY||Risk Ratio (RR)|0.77|||||TWO_SIDED|95.0|0.38|1.55|||||Widths of the confidence intervals for components of the primary outcome have not been adjusted for multiplicity, and should not be used to infer definitive effects of management strategies.|||1.55|0.38|
72345618|NCT01990612|144214118|SUPERIORITY||Risk Ratio (RR)|1.28|||||TWO_SIDED|95.0|0.48|3.42|||||Widths of the confidence intervals for components of the primary outcome have not been adjusted for multiplicity, and should not be used to infer definitive effects of management strategies.|||3.42|0.48|
72345619|NCT01990612|144214119|SUPERIORITY||Risk Ratio (RR)|0.4|||||TWO_SIDED|95.0|0.06|1.79|||||Exact confidence intervals are provided for rare outcomes. Widths of the confidence intervals for components of the primary outcome have not been adjusted for multiplicity, and should not be used to infer definitive effects of management strategies.|||1.79|0.06|
72345620|NCT01990612|144214120|SUPERIORITY||Risk Ratio (RR)|0.84|||<|0.001|TWO_SIDED|95.0|0.76|0.93||The P value remained significant after controlling for multiple comparisons with the false discovery rate method.|Chi-squared|||||0.93|0.76|<0.001
72345621|NCT01990612|144214121|SUPERIORITY||Risk Ratio (RR)|0.58||||0.02|TWO_SIDED|95.0|0.36|0.92||The P value remained significant after controlling for multiple comparisons with the false discovery rate method.|Chi-squared|||||0.92|0.36|0.02
72345622|NCT01990612|144214122|SUPERIORITY||Risk Ratio (RR)|0.85||||0.07|TWO_SIDED|95.0|0.72|1.01|||Chi-squared|||||1.01|0.72|0.07
72345623|NCT01990612|144214123|SUPERIORITY||Risk Ratio (RR)|0.94||||0.35|TWO_SIDED|95.0|0.83|1.07|||Chi-squared|||||1.07|0.83|0.35
72345624|NCT01990612|144214124|SUPERIORITY||Risk Ratio (RR)|1.15||||0.33|TWO_SIDED|95.0|0.87|1.52|||Chi-squared|||||1.52|0.87|0.33
72345625|NCT01990612|144214126|SUPERIORITY||Risk Ratio (RR)|0.5||||0.26|TWO_SIDED|95.0|0.13|1.55|||Chi-squared||Exact confidence intervals are provided for rare outcomes.|||1.55|0.13|0.26
72345626|NCT01990612|144214127|SUPERIORITY||Risk Ratio (RR)|0.64|||<|0.001|TWO_SIDED|95.0|0.56|0.74||The P value remained significant after controlling for multiple comparisons with the false discovery rate method.|Chi-squared|||||0.74|0.56|<0.001
72345627|NCT01990612|144214128|SUPERIORITY||Risk Ratio (RR)|1.03||||0.81|TWO_SIDED|95.0|0.82|1.29|||Chi-squared|||||1.29|0.82|0.81
72345628|NCT01990612|144214129|SUPERIORITY||||||<|0.001||||||The P value remained significant after controlling for multiple comparisons with the false discovery rate method.|Chi-squared|||Analysis for 6-96 hours after delivery||||<0.001
72345629|NCT01990612|144214129|SUPERIORITY|||||||0.01||||||The P value remained significant after controlling for multiple comparisons with the false discovery rate method.|Chi-squared|||Analysis for 4-8 weeks after delivery||||0.01
72345630|NCT01990612|144214130|SUPERIORITY||||||<|0.001||||||The P value remained significant after controlling for multiple comparisons with the false discovery rate method.|Chi-squared|||Analysis for Worst labor pain score||||<0.001
72345631|NCT01990612|144214130|SUPERIORITY||||||<|0.001||||||The P value remained significant after controlling for multiple comparisons with the false discovery rate method.|Chi-squared|||Analysis for Overall labor pain score||||<0.001
72345632|NCT01990612|144214131|SUPERIORITY||Risk Ratio (RR)|0.76||||0.15|TWO_SIDED|95.0|0.53|1.1|||Chi-squared|||||1.10|0.53|0.15
72345633|NCT01990612|144214132|SUPERIORITY||Risk Ratio (RR)|1.99||||1|TWO_SIDED|95.0|0.26|26.8|||Chi-squared|The P-values has not been adjusted for multiplicity of comparisons of secondary outcomes.|Exact confidence intervals are provided for rare outcomes.|||26.8|0.26|1.00
72345634|NCT01990612|144214134|SUPERIORITY|||||||0.01|||||||Cochran-Armitage trend test|||||||0.01
72345635|NCT01990612|144214135|SUPERIORITY||Risk Ratio (RR)|0.92||||0.56|TWO_SIDED|95.0|0.68|1.23|||Chi-squared|||||1.23|0.68|0.56
72345636|NCT01990612|144214136|SUPERIORITY||Risk Ratio (RR)|0.9||||0.56|TWO_SIDED|95.0|0.64|1.28|||Chi-squared|||||1.28|0.64|0.56
72345637|NCT01990612|144214137|SUPERIORITY||Risk Ratio (RR)|0.79||||0.75|TWO_SIDED|95.0|0.2|2.74|||Chi-squared||Exact confidence intervals are provided for rare outcomes.|||2.74|0.20|0.75
72345638|NCT01990612|144214138|SUPERIORITY||Risk Ratio (RR)|1.01||||0.91|TWO_SIDED|95.0|0.81|1.27|||Chi-squared|||||1.27|0.81|0.91
72345639|NCT01990612|144214139|SUPERIORITY||Risk Ratio (RR)|1.05||||0.84|TWO_SIDED|95.0|0.66|1.66|||Chi-squared|||||1.66|0.66|0.84
72345640|NCT01990612|144214140|SUPERIORITY||Risk Ratio (RR)|0.9||||0.13|TWO_SIDED|95.0|0.79|1.03|||Chi-squared|||||1.03|0.79|0.13
72345641|NCT01990612|144214141|SUPERIORITY||||||<|0.001|||||||Wilcoxon Rank-Sum|||||||<0.001
72345642|NCT01990612|144214142|SUPERIORITY|||||||0.01||||||The P value remained significant after controlling for multiple comparisons with the false discovery rate method.|Cochran-Armitage trend test|||||||0.01
72345643|NCT01990612|144214143|SUPERIORITY|||||||0.002||||||The P value remained significant after controlling for multiple comparisons with the false discovery rate method.|Cochran-Armitage trend test|||||||0.002
72345644|NCT01990612|144214145|OTHER||Odds Ratio, log|1.01||||0.88|TWO_SIDED|95.0|0.89|1.15||Odds ratios from multinomial logistic regression.|Regression, Logistic|||Multinomial logistic regression using participants who are breastfeeding only as the reference group. This analysis compares the participants who are breastfeeding and formula feeding to participants who are only breastfeeding.||1.15|0.89|0.88
72345645|NCT01990612|144214145|OTHER||Odds Ratio, log|0.98||||0.78|TWO_SIDED|95.0|0.86|1.12|||Regression, Logistic|||Multinomial logistic regression using participants who are breastfeeding only as the reference group. This analysis compares the participants who are only formula feeding to participants who are only breastfeeding.||1.12|0.86|0.78
72345646|NCT00360724|144214156|SUPERIORITY_OR_OTHER||F statistics|9.43||||0.003|||||||Repeated Measures ANOVA|df 1,55|time X Drug group, f=9.43,df 1,55, p=.003|Repeated measures ANOVA was used to compare measures between baseline and week 10.||||.003
72345647|NCT00360724|144214158|SUPERIORITY_OR_OTHER||F statistics|8.72||||0.05|||||||Repeated Measures ANOVA|d.f. 1,55|Time x Treatment: F=8.72, d.f=1,55, p=0.05|Repeated measures ANOVA was used to compare measures between baseline and week 10.||||0.05
72345648|NCT00360724|144214159|SUPERIORITY_OR_OTHER||F statistics|5.33||||0.025|||||||Repeated measures ANOVA|d.f. 1,55||Repeated measures ANOVA was used to compare measures between baseline and week 10.||||0.025
72345649|NCT00360724|144214160|SUPERIORITY_OR_OTHER||F statistics|0.26||||0.6|||||||Repeated measures ANOVA|d.f.=1,55||Repeated measures ANOVA was used to compare measures between baseline and week 10.||||0.6
72345650|NCT00360724|144214165|OTHER||Mean Difference (Final Values)|4.0||||0.002|TWO_SIDED||||||t-test, 2 sided|||||||0.002
72345651|NCT00360724|144214166|OTHER||Mean Difference (Final Values)|0.4||||0.9|TWO_SIDED||||||t-test, 2 sided|||||||0.9
72345652|NCT04978818|144214201|NON_INFERIORITY|The anti-PRP IgG GMC for children receiving dose 1 of Vaxelis® was defined a priori as non-inferior if it was within a 1.5-fold margin of the GMC for children receiving dose 1 of PedvaxHIB®, corresponding to the lower bound of the 95% confidence interval (CI) of the IgG GMC ratio (Vaxelis® to PedvaxHIB®) being greater than 0.67.|Ratio of Geometric Mean Concentration|1.03||||0.85|TWO_SIDED|95.0|0.75|1.41|||Constrained Longitudinal Analysis||The lower bound of the 95% confidence interval was greater than the pre-specified non-inferiority margin of 0.67. Thus, Vaxelis® post-dose 1 anti-PRP IgG immunogenicity met the non-inferiority criterion compared to PedvaxHIB®.|||1.41|0.75|0.85
72345653|NCT04978818|144214202|OTHER|||||||0.39|||||||Chi-squared|||||||0.39
72345654|NCT04978818|144214203|OTHER|||||||0.64|||||||Chi-squared|||||||0.64
72345655|NCT04978818|144214204|OTHER|||||||0.87|||||||Chi-squared|||||||0.87
72345656|NCT04978818|144214205|OTHER|||||||0.3|||||||Chi-squared|||||||0.3
72345657|NCT04978818|144214206|OTHER|||||||0.15|||||||Chi-squared|||||||0.15
72345658|NCT04978818|144214207|OTHER|||||||0.03|||||||Chi-squared|||||||0.03
72345659|NCT06037408|144214209|SUPERIORITY||Mean Difference (Final Values)|-57.13|STANDARD_ERROR_OF_MEAN|2.759||0.0001|TWO_SIDED|95.0|-63.99|-50.27||Sidak's test was used to adjust for multiple comparisons.|ANOVA|Degrees of freedom, 42.19||||-50.27|-63.99|0.0001
72345660|NCT06037408|144214210|SUPERIORITY||Mean Difference (Final Values)|25.12|STANDARD_ERROR_OF_MEAN|4.459|<|0.0001|TWO_SIDED|95.0|13.26|36.99|||ANOVA|Degrees of freedom, 28.16.||||36.99|13.26|<0.0001
72428949|NCT01556763|144368769|SUPERIORITY_OR_OTHER||||||=|0.008||95.0|||||ANCOVA|||Baseline value was the covariate and all values obtained during the treatment period were averaged together. This value was adjusted by regression against the baseline and estimation of a new value as if all subjects possessed the same baseline.||||=0.008
72428950|NCT02584855|144368770|SUPERIORITY||||||<|0.001|||||||Log Rank|||Log Rank Test adjusting for geographic region and conventional disease-modifying antirheumatic drug (cDMARD) use at the time of double blind randomization.||||<0.001
72428951|NCT02584855|144368771|SUPERIORITY||Odds Ratio (OR)|-45.6|||||TWO_SIDED|95.0|-58.8|-32.3||||||Logistic regression adjusting for treatment, geographic region, and cDMARD use at the time of double-blind randomization .||-32.3|-58.8|
72428952|NCT02584855|144368774|SUPERIORITY||||||<|0.001|||||||Log Rank|||Log Rank Test adjusting for geographic region and cDMARD use at the time of double blind randomization.||||<0.001
72428953|NCT02584855|144368775|SUPERIORITY||||||<|0.001|||||||Log Rank|||Log Rank Test adjusting for geographic region and cDMARD use at the time of double blind randomization.||||<0.001
72428954|NCT02584855|144368776|SUPERIORITY||||||<|0.001|||||||Log Rank|||Log Rank Test adjusting for geographic region and cDMARD use at the time of double blind randomization.||||<0.001
72428955|NCT02584855|144368777|SUPERIORITY||||||<|0.001|||||||Log Rank|||Log Rank Test adjusting for geographic region and cDMARD use at the time of double blind randomization.||||<0.001
72428956|NCT02584855|144368778|SUPERIORITY||||||<|0.001|||||||Log Rank|||Log Rank Test adjusting for geographic region and cDMARD use at the time of double blind randomization.||||<0.001
72428957|NCT02258464|144368786|OTHER||Hazard Ratio (Radium 223/Placebo)|0.745||||0.3339|TWO_SIDED|80.0|0.504|1.102||The SSE-FS was compared using a stratified log-rank test with a 2-sided alpha of 0.2|Log Rank|||The null hypothesis that both treatment groups have the same SSE-FS distribution will be tested against the alternative hypothesis that the distribution of SSE-FS time in radium-223 dichloride is different from the placebo group||1.102|0.504|0.3339
72428958|NCT02258464|144368787|OTHER||Hazard ratio (Radium 223/Placebo)|0.888||||0.7259|TWO_SIDED|80.0|0.576|1.37|||Log Rank|||||1.370|0.576|0.7259
72428959|NCT02258464|144368788|OTHER||Hazard ratio (Radium 223/Placebo)|0.932||||0.8785|TWO_SIDED|80.0|0.513|1.693|||Log Rank|||||1.693|0.513|0.8785
72428960|NCT02258464|144368789|OTHER||Hazard ratio (Radium 223/Placebo)|0.824||||0.524|TWO_SIDED|80.0|0.556|1.22|||Log Rank|||||1.220|0.556|0.5240
72428961|NCT02258464|144368790|OTHER||Difference (Radium 223 - Placebo) %|11.8||||0.345|TWO_SIDED|80.0|-2.7|26.3|||Cochran-Mantel-Haenszel|||||26.3|-2.7|0.345
72428962|NCT02258464|144368791|OTHER||Hazard ratio (Radium 223/Placebo)|0.968||||0.9128|TWO_SIDED|80.0|0.657|1.425|||Log Rank|||||1.425|0.657|0.9128
72428963|NCT02258464|144368792|OTHER||Hazard ratio (Radium 223/Placebo)|1.023||||0.9227|TWO_SIDED|80.0|0.753|1.391|||Log Rank|||||1.391|0.753|0.9227
72428964|NCT02138747|144368795|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-2.89|STANDARD_ERROR_OF_MEAN|0.997||0.004|TWO_SIDED|95.0|-4.86|-0.93||p-value based on the ANOVA model|ANOVA|||Tolerability score was analyzed using the ANOVA model (Model #1), with sequence group, study period, period-by-sequence interaction, gender and treatment group as factors, and subject-within-sequence as a random term. p-value based on the ANOVA model. Difference used mirabegron as the reference (difference =tolterodine ER -mirabegron). A negative difference indicates better reported tolerability with mirabegron than with tolterodine ER.||-0.93|-4.86|0.004
72428965|NCT02138747|144368796|SUPERIORITY_OR_OTHER_LEGACY|||||||0.77||||||P value was obtained using Mainland-Gart test to compare the proportion of preference for each treatment group. The denominator excluded patients with No Preference.|Mainland-Gart|||Participants who selected Mirabegron or Tolterodine ER were included in the denominator and participants with No Preference were excluded. Comparison was between Mirabegron vs Tolterodine ER.||||0.77
72428966|NCT02138747|144368805|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.05|STANDARD_ERROR_OF_MEAN|0.224||0.971|TWO_SIDED|95.0|-0.39|0.49||Adjusted P value was generated from the ANCOVA model for the period-by-treatment interaction.|ANCOVA|||Adjusted difference vs mirabegron where difference used mirabegron as the reference (difference = tolterodine ER - mirabegron).||0.49|-0.39|0.971
72428967|NCT02138747|144368806|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.11|STANDARD_ERROR_OF_MEAN|0.199||0.211|TWO_SIDED|95.0|-0.28|0.5||Adjusted P value was generated from the ANCOVA model for the period-by-treatment interaction.|ANCOVA|||Adjusted difference vs mirabegron where difference used mirabegron as the reference (difference = tolterodine ER - mirabegron).||0.50|-0.28|0.211
72428968|NCT00932646|144368819|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.172|STANDARD_ERROR_OF_MEAN|0.017|<|0.0001||95.0|0.139|0.205|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Olo 5 mcg qd minus Placebo|||0.205|0.139|<0.0001
72428969|NCT00932646|144368819|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.174|STANDARD_ERROR_OF_MEAN|0.017|<|0.0001||95.0|0.14|0.208|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Olo 10 mcg qd minus Placebo|||0.208|0.140|<0.0001
72428970|NCT00932646|144368819|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.158|STANDARD_ERROR_OF_MEAN|0.017|<|0.0001||95.0|0.124|0.191|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Form 12 mcg bid minus Placebo|||0.191|0.124|<0.0001
72428971|NCT00932646|144368820|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.145|STANDARD_ERROR_OF_MEAN|0.016|<|0.0001||95.0|0.114|0.176|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Olo 5 mcg qd minus Placebo|||0.176|0.114|<0.0001
72428972|NCT00932646|144368820|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.147|STANDARD_ERROR_OF_MEAN|0.016|<|0.0001||95.0|0.116|0.179|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Olo 10 mcg qd minus Placebo|||0.179|0.116|<0.0001
72428973|NCT00932646|144368820|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.156|STANDARD_ERROR_OF_MEAN|0.016|<|0.0001||95.0|0.125|0.187|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Form 12 mcg bid minus Placebo|||0.187|0.125|<0.0001
72345661|NCT01211340|144214211|SUPERIORITY_OR_OTHER_LEGACY|||||||0.18|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||The first analysis examined change from baseline to last available measure prior to death or the end of the study. The pre/post change was calculated for each participant and the Wilcoxon rank sum test was used to compare usual care and intervention groups with respect to changes. All randomized caregivers with at least 1 post baseline measure were included in the analysis.||||.18
72345662|NCT01211340|144214211|SUPERIORITY_OR_OTHER_LEGACY|||||||0.18|TWO_SIDED|95.0|||||Regression, Linear|No significant difference found between groups||The secondary analysis used a linear mixed model to test for groups differences over time. To account for repeated- measures nature of the data and the varying duration of participation, both participant specific intercept and slopes were treated as random effects. To minimize the leverage of relatively small number of participants with extremely long follow-up times we limited the number of days followed to 122, which was the 75th percentile of the days in the combined study.||||.18
72345663|NCT01211340|144214211|SUPERIORITY_OR_OTHER_LEGACY|||||||0.18|TWO_SIDED|95.0|||||Spearmans rank|No differences found||To test the effects of the dose of meetings on association with overall Caregiver Perceptions of Pain Medicine Questionaire (CPMQ) change we used Spearman rank correlation coefficient||||.18
72345664|NCT01211340|144214212|SUPERIORITY_OR_OTHER_LEGACY|||||||0.15|TWO_SIDED|95.0|||||Wilcxon Rank Sum Test|||The first analysis examined change from baseline to last available measure prior to death or the end of the study. The pre/post change was calculated for each participant and the Wilcoxon rank sum test was used to compare usual care and intervention groups with respect to changes. All randomized caregivers with at least 1 post baseline measure were included in the analysis.||||.15
72345665|NCT01211340|144214212|SUPERIORITY_OR_OTHER_LEGACY|||||||0.15|||||||Regression, Linear|||The secondary analysis used a linear mixed model to test for groups differences over time. To account for repeated- measures nature of the data and the varying duration of participation, both participant specific intercept and slopes were treated as random effects. To minimize the leverage of relatively small number of participants with extremely long follow-up times we limited the number of days followed to 122, which was the 75th percentile of the days in the combined study.||||.15
72345666|NCT01211340|144214213|SUPERIORITY_OR_OTHER_LEGACY|||||||0.89|||||||Wilcoxon (Mann-Whitney)|||The first analysis examined change from baseline to last available measure prior to death or the end of the study. The pre/post change was calculated for each participant and the Wilcoxon rank sum test was used to compare usual care and intervention groups with respect to changes. All randomized caregivers with at least 1 post baseline measure were included in the analysis.||||.89
72345667|NCT01211340|144214213|SUPERIORITY_OR_OTHER_LEGACY|||||||0.89|||||||Regression, Linear|||The secondary analysis used a linear mixed model to test for groups differences over time. To account for repeated- measures nature of the data and the varying duration of participation, both participant specific intercept and slopes were treated as random effects. To minimize the leverage of relatively small number of participants with extremely long follow-up times we limited the number of days followed to 122, which was the 75th percentile of the days in the combined study.||||.89
72345668|NCT03755661|144214214|OTHER|pilot data to estimate effect size f-squared as the parameter as primary outcome||||||0.048||||||provide inferential statistics for data completion. Study is not designed to detect significant differences between groups|Regression, Linear|R-square change = .12; F-change (1, 20) = 4.44||pilot study to calculate effect size, study is not powered to detect significant group differences|"Computed f-squared as effect size estimate where baseline value of heavy drinking episodes entered in step 1 and condition in step 2~f- squared = .22"|||.048
72345669|NCT03755661|144214215|SUPERIORITY|"The main outcome variable is f-squared as an estimate of differences between conditions controlling for baseline value.~A statistical test is provided only for completeness as this study is not powered to detect significant effects"||||||0.34||||||F-change (1, 20) = 0.97|Regression, Linear|||pilot trial to compute effect size estimate|Computed f-squared as effect size estimate where baseline value of CAI entered in step 1 and condition in step 2 f- squared = .05, r-squared change = .04|||.34
72345670|NCT03755661|144214216|SUPERIORITY|This is a pilot trial to estimate effect sizes and not powered to detect significant differences||||||0.2||||||data provided for completeness, not powered to test differences|Regression, Linear|F-change (1, 20) = 1.80|||Computed f-squared as effect size estimate where baseline value of CAI entered in step 1 and condition in step 2 f- squared = .09, r-squared change = .058|||.20
72345671|NCT03755661|144214217|SUPERIORITY|Pilot trial not powered to detect significant group differences. Data from analyses presented for completeness. Primary outcome is effect size estimates||||||0.19|||||||Regression, Linear|F-change (1, 20) = 1.83||Pilot trial not powered to detect significant group differences|Computed f-squared as effect size estimate where baseline value of CAI entered in step 1 and condition in step 2 f- squared = .09, r-squared change = .048|||.19
72345672|NCT03755661|144214218|SUPERIORITY|||||||0.26||||||F-change (1, 19) = 1.34|Regression, Linear|||Not powered to test significant differences. provide data on effect size estimate below|Computed f-squared as effect size estimate where baseline value of CAI entered in step 1 and condition in step 2 f- squared = .05, r-squared change = .04|||.26
72345673|NCT05399290|144214238|OTHER|Chi square analysis was conducted to detect any significant between group differences (100 mg vs 20 mg) in perceived acne severity.||||||0.677|||||||Chi-squared|||||||0.677
72345674|NCT05399290|144214238|OTHER|Friedman's test was conducted for the 100 mg treatment arm to detect any significant within group differences in perceived acne severity.||||||0.002|||||||Friedman's test|||||||0.002
72345675|NCT05399290|144214238|OTHER|Friedman's test was conducted for the 20 mg treatment arm to detect any significant within group differences in perceived acne severity.||||||0.018|||||||Fried|||||||0.018
72345676|NCT02964767|144214251|OTHER||||||<|0.049|||||||t-test, 2 sided|||||||<0.049
72345677|NCT00659230|144214252|SUPERIORITY_OR_OTHER||Effect Size|-0.18||||0.723|TWO_SIDED|90.0|-0.64|0.27|||ANOVA||Effect size (ES) for change in CAPS-D score relative to baseline was calculated according to the method of Cohen.|The analysis was conducted using a repeated-measures analysis of variance (ANOVA) model. The model consisted of two factors - treatment at two levels and time (5 time points including baseline) and group by time interaction.||0.27|-0.64|0.723
72345678|NCT00659230|144214253|SUPERIORITY||Effect Size|-0.07||||0.54|TWO_SIDED|90.0|-0.52|0.39|||ANOVA||Effect size (ES) for change in CAPS-D score relative to baseline was calculated according to the method of Cohen.|||0.39|-.52|0.540
72345679|NCT00659230|144214254|SUPERIORITY||Effect size|-0.18||||0.951|TWO_SIDED|90.0|-0.64|0.27|||ANOVA||Effect size (ES) for change in CAPS-D score relative to baseline was calculated according to the method of Cohen.|||0.27|-0.64|0.951
72345680|NCT00659230|144214255|SUPERIORITY||Effect Size|0.11||||0.396|TWO_SIDED|90.0|-0.35|0.56|||ANOVA||Effect size (ES) for change in CAPS-D score relative to baseline was calculated according to the method of Cohen.|||0.56|-0.35|0.396
72345681|NCT02467582|144214256|SUPERIORITY|||||||0.11|||||||Log Rank|||||||0.11
72345682|NCT02467582|144214256|SUPERIORITY||Hazard Ratio (HR)|0.57|||||TWO_SIDED|90.0|0.27|1.22|||||Unstratified|||1.22|0.27|
72345683|NCT02467582|144214256|SUPERIORITY||Hazard Ratio (HR)|0.57|||||TWO_SIDED|90.0|0.22|1.46|||||Stratified|||1.46|0.22|
72345684|NCT02467582|144214257|SUPERIORITY|||||||0.089|||||||Log Rank|||||||0.089
72345685|NCT02467582|144214257|SUPERIORITY||Hazard Ratio (HR)|0.49|||||TWO_SIDED|90.0|0.21|1.19|||||Unstratified|||1.19|0.21|
72345686|NCT02467582|144214257|SUPERIORITY||Hazard Ratio (HR)|0.56|||||TWO_SIDED|90.0|0.2|1.55|||||Stratified|||1.55|0.20|
72345687|NCT02467582|144214258|SUPERIORITY|||||||0.3|||||||Log Rank|||||||0.3
72345688|NCT02467582|144214258|SUPERIORITY||Hazard Ratio (HR)|0.71|||||TWO_SIDED|90.0|0.23|2.13|||||Unstratified|||2.13|0.23|
72345689|NCT02467582|144214258|SUPERIORITY||Hazard Ratio (HR)|0.6|||||TWO_SIDED|90.0|0.15|2.43|||||Stratified|||2.43|0.15|
72345690|NCT01370265|144214261|SUPERIORITY_OR_OTHER|||||||0.14||95.0|||||t-test, 2 sided|||Statistical analysis for hyperemic global MBF between Regadenoson and Adenosine groups (per intervention), alpha level of 0.05.||||0.14
72345691|NCT01370265|144214263|SUPERIORITY_OR_OTHER|||||||0.21||95.0|||||t-test, 2 sided|||Statistical analysis for Cardiac Flow Rate (CFR) between Regadenoson and Adenosine groups (per intervention), alpha level of 0.05||||0.21
72345692|NCT01370265|144214264|SUPERIORITY_OR_OTHER|||||||0.57||95.0|||||t-test, 2 sided|||Statistical analysis comparing Regadenoson and Adenosine groups (per intervention), for Hyperemic MBF Anterior, alpha level of 0.05.||||0.57
72345693|NCT01370265|144214264|SUPERIORITY_OR_OTHER|||||||0.13||95.0|||||t-test, 2 sided|||Statistical analysis comparing Regadenoson and Adenosine groups (per intervention) for Hyperemic MBF Septum, alpha level of 0.05.||||0.13
72345694|NCT01370265|144214264|SUPERIORITY_OR_OTHER|||||||0.44||95.0|||||t-test, 2 sided|||Statistical analysis comparing Regadenoson and Adenosine groups (per intervention)for Hyperemic MBF Inferior, alpha level of 0.05.||||0.44
72345695|NCT01370265|144214264|SUPERIORITY_OR_OTHER|||||||0.74||95.0|||||t-test, 2 sided|||Statistical analysis comparing Regadenoson and Adenosine groups (per intervention) for Hyperemic MBF Lateral, alpha level of 0.05.||||0.74
72345696|NCT01370265|144214265|SUPERIORITY_OR_OTHER|||||||0.78||95.0|||||t-test, 2 sided|||Statistical analysis comparing Regadenoson and Adenosine groups (per intervention for CFR Anterior, alpha level of 0.05.||||0.78
72345697|NCT01370265|144214265|SUPERIORITY_OR_OTHER|||||||0.42||95.0|||||t-test, 2 sided|||Statistical analysis comparing Regadenoson and Adenosine groups (per intervention) for CFR Septum, alpha level of 0.05||||0.42
72345698|NCT01370265|144214265|SUPERIORITY_OR_OTHER|||||||0.96||95.0|||||t-test, 2 sided|||Statistical analysis comparing Regadenoson and Adenosine groups (per intervention for CFR Inferior, alpha level of 0.05||||0.96
72345699|NCT01370265|144214265|SUPERIORITY_OR_OTHER|||||||0.13||95.0|||||t-test, 2 sided|||Statistical analysis comparing Regadenoson and Adenosine groups (per intervention) for CFR Lateral, alpha level of 0.05.||||0.13
72345700|NCT01370265|144214266|SUPERIORITY_OR_OTHER|||||||0.28||95.0|||||t-test, 2 sided|||Statistical analysis comparing Regadenoson and Adenosine groups (per intervention) for resting heart rate, alpha level of 0.05.||||0.28
72345701|NCT01370265|144214266|SUPERIORITY_OR_OTHER|||||||0.51||95.0|||||t-test, 2 sided|||Statistical analysis comparing Regadenoson and Adenosine groups (per intervention) for hyperemic heart rate, alpha level of 0.05.||||0.51
72345702|NCT01370265|144214267|SUPERIORITY_OR_OTHER|||||||0.31||95.0|||||t-test, 2 sided|||Statistical analysis comparing Regadenoson and Adenosine groups (per intervention) for systolic blood pressure, alpha level of 0.05.||||0.31
72345703|NCT01370265|144214267|SUPERIORITY_OR_OTHER|||||||0.08||95.0|||||t-test, 2 sided|||Statistical analysis comparing Regadenoson and Adenosine groups (per intervention) for diastolic blood pressure, alpha level of 0.05.||||0.08
72345704|NCT01115673|144214274|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|469.37|||<|0.001|||||||ANOVA|Treatment and baseline pain categorical ratings were factors.|SPRID6 = 0.25 times (PRID at 15 min + PRID at 30 min + PRID at 45 min + PRID at 60 min + PRID at 75 min + PRID at 90 min) + 0.5 times (PRID at 120 minutes) + PRID at 3 hours + PRID at 4 hours + PRID at 5 hours + PRID at 6 hours.|First test H1: acetaminophen 1000 mg vs placebo at the alpha = 0.025 one-tail level; If H1 was rejected then, Test H2: acetaminophen 1000 mg vs acetaminophen 650 mg, and Test H3: acetaminophen 650 mg vs placebo; H2 and H3 were each tested at the alpha = 0.025 one-tail level.||||<0.001
72345705|NCT01115673|144214274|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|102.09||||0.001|||||||ANOVA|Treatment and baseline pain categorical ratings were factors.|SPRID6 = 0.25 times (PRID at 15 min + PRID at 30 min + PRID at 45 min + PRID at 60 min + PRID at 75 min + PRID at 90 min) + 0.5 times (PRID at 120 minutes) + PRID at 3 hours + PRID at 4 hours + PRID at 5 hours + PRID at 6 hours.|First test H1: acetaminophen 1000 mg vs placebo at the alpha = 0.025 one-tail level; If H1 was rejected then, Test H2: acetaminophen 1000 mg vs acetaminophen 650 mg, and Test H3: acetaminophen 650 mg vs placebo; H2 and H3 were each tested at the alpha = 0.025 one-tail level.||||0.001
72345706|NCT01115673|144214274|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|367.28|||<|0.001|||||||ANOVA|Treatment and baseline pain categorical ratings were factors.|SPRID6 = 0.25 times (PRID at 15 min + PRID at 30 min + PRID at 45 min + PRID at 60 min + PRID at 75 min + PRID at 90 min) + 0.5 times (PRID at 120 minutes) + PRID at 3 hours + PRID at 4 hours + PRID at 5 hours + PRID at 6 hours.|First test H1: acetaminophen 1000 mg vs placebo at the alpha = 0.025 one-tail level; If H1 was rejected then, Test H2: acetaminophen 1000 mg vs acetaminophen 650 mg, and Test H3: acetaminophen 650 mg vs placebo; H2 and H3 were each tested at the alpha = 0.025 one-tail level.||||<0.001
72345707|NCT01115673|144214275|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|226.7|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
72345708|NCT01115673|144214275|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|48.14||||0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||0.001
72345709|NCT01115673|144214275|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|178.56|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
72345710|NCT01115673|144214276|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|242.67|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
72345711|NCT01115673|144214276|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|53.95||||0.002||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||0.002
72345712|NCT01115673|144214276|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|188.72|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
72345713|NCT01115673|144214277|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.3||||0.037||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||0.037
72345714|NCT01115673|144214277|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.36||||0.294||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||0.294
72345715|NCT01115673|144214277|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.66||||0.006||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||0.006
72345716|NCT01115673|144214278|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|20.85|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
72345717|NCT01115673|144214278|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.14||||0.946||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||0.946
72428974|NCT00932646|144368821|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.186|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.149|0.223|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Olo 5 mcg qd minus Placebo|||0.223|0.149|<0.0001
72345718|NCT01115673|144214278|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|20.99|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
72345719|NCT01115673|144214279|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|33.68|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
72345720|NCT01115673|144214279|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.06||||0.661||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||0.661
72345721|NCT01115673|144214279|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|32.62|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
72345722|NCT01115673|144214280|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|40.56|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
72345723|NCT01115673|144214280|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.88||||0.13||95.0||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||0.13
72345724|NCT01115673|144214280|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|36.67|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
72345725|NCT01115673|144214281|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|43.97|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
72345726|NCT01115673|144214281|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.42||||0.041||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||0.041
72345727|NCT01115673|144214281|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|38.55|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
72345728|NCT01115673|144214282|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|44.97|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
72345729|NCT01115673|144214282|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.34||||0.02||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||0.02
72345730|NCT01115673|144214282|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|38.63|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
72345731|NCT01115673|144214283|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|47.46|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
72345732|NCT01115673|144214283|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.08||||0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||0.001
72345733|NCT01115673|144214283|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|38.38|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
72345734|NCT01115673|144214284|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|43.42|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
72345735|NCT01115673|144214284|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.83||||0.002||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||0.002
72345736|NCT01115673|144214284|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|34.59|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
72428975|NCT00932646|144368821|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.198|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.162|0.235|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Olo 10 mcg qd minus Placebo|||0.235|0.162|<0.0001
72428976|NCT00932646|144368821|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.213|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.176|0.25|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Form 12 mcg bid minus Placebo|||0.250|0.176|<0.0001
72428977|NCT00932646|144368822|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.192|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.154|0.23|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Olo 5 mcg qd minus Placebo|||0.230|0.154|<0.0001
72345737|NCT01115673|144214285|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|41.99|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
72345738|NCT01115673|144214285|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.57|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
72345739|NCT01115673|144214285|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|31.42|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
72345740|NCT01115673|144214286|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|38.04|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
72345741|NCT01115673|144214286|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.82|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
72345742|NCT01115673|144214286|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|27.22|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
72345743|NCT01115673|144214287|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|32.45|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
72345744|NCT01115673|144214287|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.58||||0.002||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||0.002
72345745|NCT01115673|144214287|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|22.87|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
72345746|NCT01115673|144214288|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.35||||0.028||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||0.028
72345747|NCT01115673|144214288|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.13||||0.462||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||0.462
72345748|NCT01115673|144214288|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.48||||0.008||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||0.008
72345749|NCT01115673|144214289|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|24.81|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
72345750|NCT01115673|144214289|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3||||0.907||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||0.907
72345751|NCT01115673|144214289|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|25.11|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
72345752|NCT01115673|144214290|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|38.19|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
72345753|NCT01115673|144214290|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.32||||0.655||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||0.655
72345754|NCT01115673|144214290|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|36.87|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
72428978|NCT00932646|144368822|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.197|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001||95.0|0.158|0.235|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Olo 10 mcg qd minus Placebo|||0.235|0.158|<0.0001
72428979|NCT00932646|144368822|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.217|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001||95.0|0.178|0.255|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Form 12 mcg bid minus Placebo|||0.255|0.178|<0.0001
72428980|NCT00932646|144368823|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.097|STANDARD_ERROR_OF_MEAN|0.026||0.0003||95.0|0.045|0.148|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Olo 5 mcg qd minus Placebo|||0.148|0.045|0.0003
72345755|NCT01115673|144214291|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|46.15|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
72345756|NCT01115673|144214291|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.33||||0.155||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||0.155
72345757|NCT01115673|144214291|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|41.82|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
72345758|NCT01115673|144214292|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|49.69|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
72345759|NCT01115673|144214292|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.04||||0.05||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||0.05
72345760|NCT01115673|144214292|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|43.65|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
72345761|NCT01115673|144214293|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|49.83|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
72345762|NCT01115673|144214293|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.74||||0.032||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||0.032
72345763|NCT01115673|144214293|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|43.1|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
72345764|NCT01115673|144214294|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|52.36|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
72345765|NCT01115673|144214294|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.52||||0.003||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||0.003
72345766|NCT01115673|144214294|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|42.84|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
72345767|NCT01115673|144214295|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|46.8|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
72345768|NCT01115673|144214295|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.04||||0.002||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||0.002
72345769|NCT01115673|144214295|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|36.75|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
72345770|NCT01115673|144214296|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|43.84|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
72345771|NCT01115673|144214296|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.82|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
72345772|NCT01115673|144214296|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|32.02|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
72345773|NCT01115673|144214297|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|38.4|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
72428981|NCT00932646|144368823|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.103|STANDARD_ERROR_OF_MEAN|0.026||0.0001||95.0|0.051|0.155|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Olo 10 mcg qd minus Placebo|||0.155|0.051|0.0001
72428982|NCT00932646|144368823|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.08|STANDARD_ERROR_OF_MEAN|0.026||0.0026||95.0|0.028|0.132|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Form 12 mcg bid minus Placebo|||0.132|0.028|0.0026
72345774|NCT01115673|144214297|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.68|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
72345775|NCT01115673|144214297|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|26.72|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
72345776|NCT01115673|144214298|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|33.94|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
72345777|NCT01115673|144214298|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.4||||0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||0.001
72345778|NCT01115673|144214298|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|22.55|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
72345779|NCT01115673|144214299|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.65||||0.027||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||0.027
72345780|NCT01115673|144214299|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.49||||0.365||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||0.365
72345781|NCT01115673|144214299|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.14||||0.005||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||0.005
72345782|NCT01115673|144214300|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|45.65|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
72345783|NCT01115673|144214300|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.45||||0.923||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||0.923
72345784|NCT01115673|144214300|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|46.1|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
72345785|NCT01115673|144214301|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|71.87|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
72345786|NCT01115673|144214301|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.38||||0.653||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||0.653
72345787|NCT01115673|144214301|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|69.49|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
72345788|NCT01115673|144214302|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|86.71|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
72345789|NCT01115673|144214302|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.21||||0.138||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||0.138
72345790|NCT01115673|144214302|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|78.49|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
72345791|NCT01115673|144214303|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|93.66|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
72345792|NCT01115673|144214303|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.46||||0.043||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||0.043
72428983|NCT00932646|144368824|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.251|STANDARD_ERROR_OF_MEAN|0.028|<|0.0001||95.0|0.195|0.306|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Olo 5 mcg qd minus Placebo|||0.306|0.195|<0.0001
72428984|NCT00932646|144368824|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.246|STANDARD_ERROR_OF_MEAN|0.028|<|0.0001||95.0|0.19|0.302|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Olo 10 mcg qd minus Placebo|||0.302|0.190|<0.0001
72345793|NCT01115673|144214303|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|82.2|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
72345794|NCT01115673|144214304|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|94.8|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
72345795|NCT01115673|144214304|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.08||||0.024||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||0.024
72345796|NCT01115673|144214304|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|81.72|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
72345797|NCT01115673|144214305|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|99.82|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
72345798|NCT01115673|144214305|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|18.6||||0.002||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||0.002
72345799|NCT01115673|144214305|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|81.23|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
72345800|NCT01115673|144214306|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|90.22|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
72345801|NCT01115673|144214306|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|18.87||||0.002||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||0.002
72345802|NCT01115673|144214306|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|71.35|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
72345803|NCT01115673|144214307|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|85.82|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
72345804|NCT01115673|144214307|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|22.39|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
72345805|NCT01115673|144214307|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|63.44|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
72345806|NCT01115673|144214308|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|76.44|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
72345807|NCT01115673|144214308|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|22.5|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
72345808|NCT01115673|144214308|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|53.94|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
72345809|NCT01115673|144214309|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|66.39|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
72428985|NCT00932646|144368824|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.235|STANDARD_ERROR_OF_MEAN|0.028|<|0.0001||95.0|0.179|0.291|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Form 12 mcg bid minus Placebo|||0.291|0.179|<0.0001
72428986|NCT00932646|144368825|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.161|STANDARD_ERROR_OF_MEAN|0.031|<|0.0001||95.0|0.101|0.222|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Olo 5 mcg qd minus Placebo|||0.222|0.101|<0.0001
72428987|NCT00932646|144368825|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.157|STANDARD_ERROR_OF_MEAN|0.031|<|0.0001||95.0|0.096|0.218|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Olo 10 mcg qd minus Placebo|||0.218|0.096|<0.0001
72428988|NCT00932646|144368825|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.223|STANDARD_ERROR_OF_MEAN|0.031|<|0.0001||95.0|0.162|0.284|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Form 12 mcg bid minus Placebo|||0.284|0.162|<0.0001
72428989|NCT00932646|144368826|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.206|STANDARD_ERROR_OF_MEAN|0.026|<|0.0001||95.0|0.155|0.258|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Olo 5 mcg qd minus Placebo|||0.258|0.155|<0.0001
72428990|NCT00932646|144368826|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.202|STANDARD_ERROR_OF_MEAN|0.027|<|0.0001||95.0|0.15|0.255|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Olo 10 mcg qd minus Placebo|||0.255|0.150|<0.0001
72345810|NCT01115673|144214309|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|20.98||||0.002||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||0.002
72345811|NCT01115673|144214309|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|45.41|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
72345812|NCT01115673|144214310|SUPERIORITY_OR_OTHER||||||<|0.001||||||The significance threshold level was 0.05 (two-sided). p-Values are based on the Wilcoxon test from PROC LIFETEST that compared survival curves.|Wilcoxon test, from SAS PROC LIFETEST|||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
72345813|NCT01115673|144214310|SUPERIORITY_OR_OTHER|||||||0.26||||||The significance threshold level was 0.05 (two-sided). p-Values are based on the Wilcoxon test from PROC LIFETEST that compared survival curves.|Wilcoxon test, from SAS PROC LIFETEST|||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||0.26
72345814|NCT01115673|144214310|SUPERIORITY_OR_OTHER||||||<|0.001||||||The significance threshold level was 0.05 (two-sided). p-Values are based on the Wilcoxon test from PROC LIFETEST that compared survival curves.|Wilcoxon test, from SAS PROC LIFETEST|||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
72345815|NCT01115673|144214311|SUPERIORITY_OR_OTHER||||||<|0.001||||||The significance threshold level was 0.05 (two-sided). p-Values are based on the Wilcoxon test from PROC LIFETEST that compared survival curves.|Wilcoxon test, from SAS PROC LIFETEST|||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
72345816|NCT01115673|144214311|SUPERIORITY_OR_OTHER|||||||0.934||||||The significance threshold level was 0.05 (two-sided). p-Values are based on the Wilcoxon test from PROC LIFETEST that compared survival curves.|Wilcoxon test, from SAS PROC LIFETEST|||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||0.934
72345817|NCT01115673|144214311|SUPERIORITY_OR_OTHER||||||<|0.001||||||The significance threshold level was 0.05 (two-sided). p-Values are based on the Wilcoxon test from PROC LIFETEST that compared survival curves.|Wilcoxon test, from SAS PROC LIFETEST|||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
72345818|NCT01115673|144214312|SUPERIORITY_OR_OTHER||||||<|0.001||||||The significance threshold level was 0.05 (two-sided). p-Values are based on the log-rank test from PROC LIFETEST that compared survival curves.|Log Rank|||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. Subjects not rescuing during the 6-hour study period had their time to rescue set to 6 hours and were censored.||||<0.001
72345819|NCT01115673|144214312|SUPERIORITY_OR_OTHER||||||<|0.001||||||The significance threshold level was 0.05 (two-sided). p-Values are based on the log-rank test from PROC LIFETEST that compared survival curves.|Log Rank|||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. Subjects not rescuing during the 6-hour study period had their time to rescue set to 6 hours and were censored.||||<0.001
72345820|NCT01115673|144214312|SUPERIORITY_OR_OTHER||||||<|0.001||||||The significance threshold level was 0.05 (two-sided). p-Values are based on the log-rank test from PROC LIFETEST that compared survival curves.|Log Rank|||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. Subjects not rescuing during the 6-hour study period had their time to rescue set to 6 hours and were censored.||||<0.001
72345821|NCT01115673|144214313|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.06|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|Cochran-Mantel-Haenszel|Stratified by categorical baseline pain rating.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
72345822|NCT01115673|144214313|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.52||||0.002||||||The significance threshold level was 0.05 (two-sided).|Cochran-Mantel-Haenszel|Stratified by categorical baseline pain rating.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||0.002
72345823|NCT01115673|144214313|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.12|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|Cochran-Mantel-Haenszel|Stratified by categorical baseline pain rating.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
72345824|NCT01115673|144214314|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.1|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|Cochran-Mantel-Haenszel|Stratified by categorical baseline pain rating.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
72345825|NCT01115673|144214314|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.49|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|Cochran-Mantel-Haenszel|Stratified by categorical baseline pain rating.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
72345826|NCT01115673|144214314|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.21|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|Cochran-Mantel-Haenszel|Stratified by categorical baseline pain rating.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
72428991|NCT00932646|144368826|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.229|STANDARD_ERROR_OF_MEAN|0.027|<|0.0001||95.0|0.176|0.281|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Form 12 mcg bid minus Placebo|||0.281|0.176|<0.0001
72345827|NCT01115673|144214315|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|18.45|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|Cochran-Mantel-Haenszel|Stratified by categorical baseline pain rating.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
72345828|NCT01115673|144214315|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.65||||0.006||||||The significance threshold level was 0.05 (two-sided).|Cochran-Mantel-Haenszel|Stratified by categorical baseline pain rating.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||0.006
72345829|NCT01115673|144214315|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|11.16|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|Cochran-Mantel-Haenszel|Stratified by categorical baseline pain rating.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
72345830|NCT01115673|144214316|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.68|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
72345831|NCT01115673|144214316|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.33||||0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||0.001
72345832|NCT01115673|144214316|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.35|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
72345833|NCT01593592|144214325|SUPERIORITY_OR_OTHER||percentage|0.0|||||TWO_SIDED|95.0||||||||A total of 70 patients were included; 35 in each arm. The sample size was calculated assuming eradication of H. pylori in at least 70% of treated patients, aiming to detect a difference of 30% based on a 0.80 power to detect significant difference (p =0.05, two-sided).||||
72345834|NCT01732770|144214327|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The lower bound of the 2-sided 95% confidence interval (CI) of (denosumab - zoledronic acid) was compared with the non-inferiority margin of -0.46% for assessing non-inferiority.|Treatment Difference|2.1|||<|0.0001|TWO_SIDED|95.0|1.6|2.6|||ANCOVA|The model included treatment, screening sCTX, baseline BMD, DXA machine type (Hologic or Lunar), and baseline BMD-by-machine type interaction.|Treatment difference = denosumab - zoledronic acid|A step-down sequential testing procedure was used in order to maintain the overall type I error rate at 5% for the tests of primary and secondary BMD endpoints. For the non-inferiority analysis the 1-sided significance level was 2.5%.||2.6|1.6|<0.0001
72345835|NCT01732770|144214328|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The lower bound of the 2-sided 95% CI) of (denosumab - zoledronic acid) was compared with the non-inferiority margin of -0.51% for assessing non-inferiority.|Treatment Difference|1.4|||<|0.0001|TWO_SIDED|95.0|1.0|1.7|||ANCOVA|The model included treatment, screening sCTX, baseline BMD, DXA machine type (Hologic or Lunar), and baseline BMD-by-machine type interaction.|Treatment difference = denosumab - zoledronic acid|A step-down sequential testing procedure was used in order to maintain the overall type I error rate at 5% for the tests of primary and secondary BMD endpoints. For the non-inferiority analysis the 1-sided significance level was 2.5%.||1.7|1.0|<0.0001
72345836|NCT01732770|144214329|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|2.1|||<|0.0001|TWO_SIDED|95.0|1.6|2.6|||ANCOVA|The model included treatment, screening sCTX, baseline BMD, DXA machine type (Hologic or Lunar), and baseline BMD-by-machine type interaction.|Treatment difference = denosumab - zoledronic acid|A step-down sequential testing procedure was used in order to maintain the overall type I error rate at 5% for the tests of primary and secondary BMD endpoints. For the superiority analysis the 2-sided significance level was 5%.||2.6|1.6|<0.0001
72345837|NCT01732770|144214330|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|1.4|||<|0.0001|TWO_SIDED|95.0|1.0|1.7|||ANCOVA|The model included treatment, screening sCTX, baseline BMD, DXA machine type (Hologic or Lunar), and baseline BMD-by-machine type interaction.|Treatment difference = denosumab - zoledronic acid|A step-down sequential testing procedure was used in order to maintain the overall type I error rate at 5% for the tests of primary and secondary BMD endpoints. For the superiority analysis the 2-sided significance level was 5%.||1.7|1.0|<0.0001
72345838|NCT01959841|144214342|NON_INFERIORITY|Wherein the non-inferiority margin was set at 10%. If the one-sided P-value was less than 0.025 between the ASP2151(400mg) once daily and the valaciclovir 1000 mg three times daily, non-inferiority of ASP2151 to valaciclovir was assumed.||||||2.41e-06|||||||Modified Farrington-Manning test|||The non-inferiority of each ASP2151 dose level versus valaciclovir was assessed stepwise using a closed testing procedure.First step analysis was performed in the ASP2151(400mg) once daily.||||0.00000241
72345839|NCT01959841|144214342|NON_INFERIORITY|Wherein the non-inferiority margin was set at 10%. If the one-sided P-value was less than 0.025 between the ASP2151(200mg) once daily and the valaciclovir 1000 mg three times daily, non-inferiority of ASP2151 to valaciclovir was assumed.||||||0.0688|||||||Modified Farrington-Manning test|||The analysis was performed in the ASP2151(200 mg) once daily only when non-inferiority of the ASP2151(400 mg) 0nce daily to valaciclovir 1000 mg three times daily was assumed.||||0.0688
72345840|NCT00666224|144214352|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.55||||0.0005|TWO_SIDED|95.0|0.4|0.77||Type of unifocal presentation at baseline, past corticosteroid treatment (Yes/No) for the initial attack prior to randomization, and center effects as covariates.|Regression, Cox|||||0.77|0.40|0.0005
72345841|NCT00666224|144214353|SUPERIORITY_OR_OTHER||Rate ratio|0.42|||<|0.0001|TWO_SIDED|95.0|0.29|0.61|||Quasi-Likelihood NB* Regression|"\*NB = Negative Binomial~Center and baseline number of enhancing lesions as covariates."||||0.61|0.29|<0.0001
72345842|NCT00666224|144214354|SUPERIORITY_OR_OTHER||Geometric means ratio|0.87||||0.0013|TWO_SIDED|95.0|0.79|0.95|||ANCOVA|Used log-transformed measurements comparing the adjusted geometric means of T2 volume. Center and baseline T2 volume used as covariates.||||0.95|0.79|0.0013
72428992|NCT00932646|144368827|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.299|STANDARD_ERROR_OF_MEAN|0.034|<|0.0001||95.0|0.233|0.365|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Olo 5 mcg qd minus Placebo|||0.365|0.233|<0.0001
72345843|NCT00666224|144214357|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.41|||<|0.0001|TWO_SIDED|95.0|0.27|0.61||Type of unifocal presentation, past corticosteroid treatment (Yes/No) for the initial attack prior to randomization and center effects as covariates.|Regression, Logistic|||||0.61|0.27|<0.0001
72345844|NCT03335774|144214364|SUPERIORITY|To determine if the 'hydrocortisone' arm was indeed superior than 'placebo' to reduce swelling and itching associated with internal hemorrhoids||||||0.8918|TWO_SIDED|95.0|||||t-test, 2 sided|||The statistical analyses were conducted using SAS software Version 9.4.All statistical tests were two-sided at a significance level of α = 0.05. Continuous data were presented using descriptive statistics (i.e. number of subjects, mean, SD, median, minimum, and maximum).Baseline value of each assessment was defined as the latest available assessment obtained prior to the first administration of the study drug.||||0.8918
72345845|NCT03335774|144214365|SUPERIORITY|To determine if the 'hydrocortisone' arm was indeed superior than 'placebo' to reduce swelling and itching associated with internal hemorrhoids||||||0.8323|TWO_SIDED|95.0|||||t-test, 2 sided|||The statistical analyses were conducted using SAS software Version 9.4.All statistical tests were two-sided at a significance level of α = 0.05. Continuous data were presented using descriptive statistics (i.e. number of subjects, mean, SD, median, minimum, and maximum).Baseline value of each assessment was defined as the latest available assessment obtained prior to the first administration of the study drug.||||0.8323
72345846|NCT03121365|144214379|EQUIVALENCE|0.05||||||0.7635|TWO_SIDED|95.0|||||t-test, 2 sided|||Bayley Scales of Infant and Toddler Development Cognitive Composite Scores between infants 12-18 months old in the Standard and Digital Arms||||.7635
72345847|NCT03121365|144214379|EQUIVALENCE|0.05||||||0.0996|||||||t-test, 2 sided|||Language Composite Scores between infants 12-18 months old in the Standard and Digital Arms||||.0996
72345848|NCT03121365|144214379|EQUIVALENCE|0.05||||||0.2291|||||||t-test, 2 sided|||Gross Motor Composite Scores between infants 12-18 months old in the Standard and Digital Arms||||.2291
72345849|NCT03121365|144214380|EQUIVALENCE|0.05||||||0.018|||||||t-test, 2 sided|||StimQ scores between infants 6 months of age and 9 months of age in the board book arm and e-book arm||||.0180
72345850|NCT03121365|144214380|EQUIVALENCE|0.05||||||0.4144|||||||t-test, 2 sided|||StimQ scores between infants 9 months of age and 12 months of age in the board book arm and e-book arm||||.4144
72345851|NCT03121365|144214380|EQUIVALENCE|0.05||||||0.4251|||||||t-test, 2 sided|||StimQ scores between infants 6 months of age and 12 months of age in the board book arm and e-book arm||||.4251
72345852|NCT03121365|144214381|SUPERIORITY|||||||0.235||||||Difference in Board Book Reading|Chi-squared|||||||0.235
72345853|NCT03121365|144214382|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
72345854|NCT03121365|144214383|SUPERIORITY|||||||0.601|||||||Chi-squared|||||||0.601
72345855|NCT03121365|144214384|SUPERIORITY|||||||0.219|||||||Chi-squared|||||||0.219
72345856|NCT03121365|144214385|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
72345857|NCT03121365|144214386|SUPERIORITY|||||||0.574|||||||Chi-squared|||||||0.574
72345858|NCT03121365|144214387|SUPERIORITY|||||||0.43|||||||Chi-squared|||||||0.430
72345859|NCT03121365|144214388|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
72345860|NCT03121365|144214389|SUPERIORITY|||||||0.861|||||||Chi-squared|||||||0.861
72345861|NCT00244101|144214399|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.78|||||TWO_SIDED|95.0|0.59|1.03||||||PS group used as standard of care. Relative risk and 95 % CI calculated for PS (reference) versus ISX or NCPAP.||1.03|0.59|
72345862|NCT00244101|144214399|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.57|||||TWO_SIDED|95.0|0.25|1.27||||||PS group used as standard of care. Relative risk and 95% CI calculated for PS (reference) versus NCPAP.||1.27|0.25|
72345863|NCT00244101|144214400|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.97|||||TWO_SIDED|95.0|0.49|1.94||||||PS group used as standard of care. Relative risk and 95 % CI calculated for PS (reference) versus ISX.||1.94|0.49|
72345864|NCT00244101|144214400|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.83|||||TWO_SIDED|95.0|0.64|1.09||||||PS group used as standard of care. Relative risk and 95% CI calculated for PS (reference) versus NCPAP.||1.09|0.64|
72428993|NCT00932646|144368827|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.302|STANDARD_ERROR_OF_MEAN|0.034|<|0.0001||95.0|0.236|0.369|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Olo 10 mcg qd minus Placebo|||0.369|0.236|<0.0001
72428994|NCT00932646|144368827|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.338|STANDARD_ERROR_OF_MEAN|0.034|<|0.0001||95.0|0.271|0.405|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Form 12 mcg bid minus Placebo|||0.405|0.271|<0.0001
72345865|NCT01959139|144214402|SUPERIORITY||Hazard Ratio (HR)|2.07|||<|0.01|TWO_SIDED|95.0|1.28|3.34|||Regression, Cox|||||3.34|1.28|<0.01
72345866|NCT01959139|144214403|SUPERIORITY||Hazard Ratio (HR)|1.74||||0.01|TWO_SIDED|95.0|1.14|2.66|||Regression, Cox|||||2.66|1.14|0.01
72428995|NCT00932646|144368828|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.132|STANDARD_ERROR_OF_MEAN|0.055||0.0163||95.0|0.024|0.239|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Olo 5 mcg qd minus Placebo|||0.239|0.024|0.0163
72345867|NCT04756804|144214409|OTHER|This was a descriptive study, no hypothesis testing was performed.|||||||||||||||||This was a descriptive study, no hypothesis testing was performed.|||
72345868|NCT05362058|144214419|NON_INFERIORITY|0.4% noninferiority margin (NIM)|LS Mean Difference|-0.09|||||TWO_SIDED|95.0|-0.22|0.04|||ANCOVA|||||0.04|-0.22|
72345869|NCT05362058|144214420|NON_INFERIORITY|0.4% noninferiority margin (NIM)|LS Mean Difference|-0.06|||||TWO_SIDED|95.0|-0.26|0.13|||ANCOVA|||||0.13|-0.26|
72345870|NCT05362058|144214421|NON_INFERIORITY|0.4% noninferiority margin (NIM)|LS Mean Difference|-0.11|||||TWO_SIDED|95.0|-0.28|0.07|||ANCOVA|||||0.07|-0.28|
72345871|NCT05362058|144214422|SUPERIORITY||LS Mean Difference|-0.09||||0.188|TWO_SIDED|95.0|-0.22|0.04|||ANCOVA|||||0.04|-0.22|0.188
72345872|NCT05362058|144214423|SUPERIORITY||LS Mean Difference|3.09||||0.043|TWO_SIDED|95.0|0.09|6.08|||ANCOVA|||||6.08|0.09|0.043
72345873|NCT05362058|144214424|SUPERIORITY||LS Mean Difference|-0.06||||0.26|TWO_SIDED|95.0|-0.17|0.05|||ANCOVA|||||0.05|-0.17|0.260
72345874|NCT05362058|144214425|SUPERIORITY||LS Mean Difference|0.27||||0.848|TWO_SIDED|95.0|-2.48|3.02|||ANCOVA|||||3.02|-2.48|0.848
72345875|NCT05362058|144214426|SUPERIORITY||LS Mean Difference|5.18||||0.014|TWO_SIDED|95.0|1.06|9.3|||ANCOVA|||Week 26 (Statistical Analysis) - LS mean was determined using ANCOVA model with Baseline + Country + HbA1c Stratum at Baseline + GLP-1 RA Use at Randomization + SU Use at Randomization + Treatment (Type III sum of squares) as variables. Missing data at Baseline were imputed with multiple imputation with assumption of missing at random. Missing data at week 26 were imputed by return-to-baseline multiple imputations approach.||9.30|1.06|0.014
72345876|NCT05362058|144214426|SUPERIORITY||LS Mean Difference|0.2||||0.918|TWO_SIDED|95.0|-3.65|4.06|||ANCOVA|||Week 52 (Statistical Analysis) - LS mean was determined using ANCOVA model with Baseline + Country + HbA1c Stratum at Baseline + GLP-1 RA Use at Randomization + SU Use at Randomization + Treatment (Type III sum of squares) as variables. Missing data at Baseline were imputed with multiple imputation with assumption of missing at random. Missing data at week 52 were imputed by return-to-baseline multiple imputations approach.||4.06|-3.65|0.918
72345877|NCT05362058|144214427|SUPERIORITY||LS Mean Difference|-0.36||||0.31|TWO_SIDED|95.0|-1.06|0.34|||Mixed Models Analysis|||Week 22 to Week 26 (Statistical Analysis)||0.34|-1.06|0.310
72345878|NCT05362058|144214427|SUPERIORITY||LS Mean Difference|-0.51||||0.138|TWO_SIDED|95.0|-1.19|0.17|||Mixed Models Analysis|||Week 48 to Week 52 (Statistical Analysis)||0.17|-1.19|0.138
72345879|NCT05362058|144214428|SUPERIORITY||LS Mean Difference|-13.2||||0.136|TWO_SIDED|95.0|-30.5|4.1|||Mixed Models Analysis|||Week 26 (Statistical Analysis)||4.1|-30.5|0.136
72345880|NCT05362058|144214428|SUPERIORITY||LS Mean Difference|-19.7||||0.026|TWO_SIDED|95.0|-37.0|-2.4|||Mixed Models Analysis|||Week 52 (Statistical Analysis)||-2.4|-37.0|0.026
72345881|NCT05362058|144214429|SUPERIORITY||Relative Rate|1.3||||0.111|TWO_SIDED|95.0|0.94|1.78|||Negative binomial model|||||1.78|0.94|0.111
72345882|NCT05362058|144214430|SUPERIORITY||Relative Rate|1.01||||0.983|TWO_SIDED|95.0|0.53|1.89|||Negative binomial model|||||1.89|0.53|0.983
72345883|NCT05362058|144214431|SUPERIORITY||LS Mean Difference|0.5||||0.025|TWO_SIDED|95.0|0.064|0.94|||Mixed Models Analysis|||Week 26 (Statistical Analysis)||0.94|0.064|0.025
72345884|NCT05362058|144214431|SUPERIORITY||LS Mean Difference|0.056||||0.801|TWO_SIDED|95.0|-0.38|0.5|||Mixed Models Analysis|||Week 52 (Statistical Analysis)||0.50|-0.38|0.801
72345885|NCT05362058|144214432|SUPERIORITY||LS Mean Difference|0.13||||0.374|TWO_SIDED|95.0|-0.15|0.41|||Mixed Models Analysis|||Week 8 to Week 12 (Statistical Analysis)||0.41|-0.15|0.374
72345886|NCT05362058|144214432|SUPERIORITY||LS Mean Difference|0.29||||0.13|TWO_SIDED|95.0|-0.09|0.67|||Mixed Models Analysis|||Week 22 to Week 26 (Statistical Analysis)||0.67|-0.09|0.130
72345887|NCT05362058|144214432|SUPERIORITY||LS Mean Difference|0.3||||0.162|TWO_SIDED|95.0|-0.12|0.72|||Mixed Models Analysis|||Week 48 to Week 52 (Statistical Analysis)||0.72|-0.12|0.162
72345888|NCT05362058|144214433|SUPERIORITY||LS Mean Difference|-0.03||||0.594|TWO_SIDED|95.0|-0.15|0.08|||Mixed Models Analysis|||Week 8 to Week 12 (Statistical Analysis)||0.08|-0.15|0.594
72428996|NCT00932646|144368828|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.139|STANDARD_ERROR_OF_MEAN|0.055||0.0118||95.0|0.031|0.247|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Olo 10 mcg qd minus Placebo|||0.247|0.031|0.0118
72428997|NCT00932646|144368828|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.148|STANDARD_ERROR_OF_MEAN|0.055||0.0076||95.0|0.04|0.256|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Form 12 mcg bid minus Placebo|||0.256|0.040|0.0076
72428998|NCT00932646|144368829|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.118|STANDARD_ERROR_OF_MEAN|0.018|<|0.0001||95.0|0.082|0.154|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Olo 5 mcg qd minus Placebo|||0.154|0.082|<0.0001
72428999|NCT00932646|144368829|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.12|STANDARD_ERROR_OF_MEAN|0.018|<|0.0001||95.0|0.084|0.157|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Olo 10 mcg qd minus Placebo|||0.157|0.084|<0.0001
72429000|NCT00932646|144368829|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.155|STANDARD_ERROR_OF_MEAN|0.018|<|0.0001||95.0|0.119|0.191|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Form 12 mcg bid minus Placebo|||0.191|0.119|<0.0001
72429001|NCT00653263|144368831|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05||95.0|||||Mixed Models Analysis|||Means and ranges were computed for the continuous baseline characteristics.For data with 5 time points (baseline and weeks 1 through 4), hypothesis tests were performed to test for a differences between baseline and each subsequent time point as well as differences between each time point For data with 3 time points hypothesis tests were performed to test for a differences between baseline and wk 2, wk 2 and wk 4, as well as between baseline and wk 4.||||<0.05
72429002|NCT00653263|144368832|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05||95.0|||||Mixed Models Analysis|||Means and ranges were computed for continuous baseline(BL)characteristics.For longitudinal data,Proc GLIMMIX in SAS was used to fit a Mixed Model with Random Intercept.For data with 5 time points, hypothesis tests were performed to test for a differences between BL and each subsequent time point as well as differences between each time point. For data with 3 time points, hypothesis tests were performed to test for a differences between BL and wk 2,wk 2and wk 4,as well as between BL and wk 4.||||<0.05
72429003|NCT00653263|144368833|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05||95.0|||||Mixed Models Analysis|||Means and ranges were computed for continuous baseline(BL)characteristics.For longitudinal data,Proc GLIMMIX in SAS was used to fit a Mixed Model with Random Intercept.For data with 5 time points, hypothesis tests were performed to test for a differences between BL and each subsequent time point as well as differences between each time point. For data with 3 time points, hypothesis tests were performed to test for a differences between BL and wk 2,wk 2and wk 4,as well as between BL and wk 4.||||<0.05
72429004|NCT02404493|144368932|SUPERIORITY_OR_OTHER||||||<|0.001||||||The significance level threshold level was 0.05.|One-sample t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||<0.001
72429005|NCT02404493|144368932|SUPERIORITY_OR_OTHER|||||||0.023||||||The significance level threshold level was 0.05.|One sample t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||0.023
72345889|NCT05362058|144214433|SUPERIORITY||LS Mean Difference|0.06||||0.266|TWO_SIDED|95.0|-0.04|0.16|||Mixed Models Analysis|||Week 22 to Week 26 (Statistical Analysis)||0.16|-0.04|0.266
72345890|NCT05362058|144214433|SUPERIORITY||LS Mean Difference|0.02||||0.791|TWO_SIDED|95.0|-0.1|0.14|||Mixed Models Analysis|||Week 48 to Week 52 (Statistical Analysis)||0.14|-0.10|0.791
72345891|NCT05362058|144214434|SUPERIORITY||LS Mean Difference|-0.41||||0.757|TWO_SIDED|95.0|-3.0|2.18|||Mixed Models Analysis|||Week 8 to Week 12 (Statistical Analysis)||2.18|-3.00|0.757
72345892|NCT05362058|144214434|SUPERIORITY||LS Mean Difference|-0.93||||0.511|TWO_SIDED|95.0|-3.72|1.85|||Mixed Models Analysis|||Week 22 to Week 26 (Statistical Analysis)||1.85|-3.72|0.511
72429006|NCT02404493|144368932|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|422.81|STANDARD_ERROR_OF_MEAN|122.905||0.003|TWO_SIDED|95.0|166.435|679.186||The significance level threshold level was 0.05.|ANCOVA|Change from baseline as response, baseline score as covariate and treatment as factor.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||679.186|166.435|0.003
72345893|NCT05362058|144214434|SUPERIORITY||LS Mean Difference|-3.39||||0.027|TWO_SIDED|95.0|-6.39|-0.39|||Mixed Models Analysis|||Week 48 to Week 52 (Statistical Analysis)||-0.39|-6.39|0.027
72345894|NCT05362058|144214435|SUPERIORITY||LS Mean Difference|1.66||||0.021|TWO_SIDED|95.0|0.26|3.07|||Mixed Models Analysis|||Week 26 (Statistical Analysis)||3.07|0.26|0.021
72345895|NCT05362058|144214435|SUPERIORITY||LS Mean Difference|2.0||||0.006|TWO_SIDED|95.0|0.57|3.44|||Mixed Models Analysis|||Week 52 (Statistical Analysis)||3.44|0.57|0.006
72345896|NCT05362058|144214436|SUPERIORITY||LS Mean Difference|-0.2||||0.638|TWO_SIDED|95.0|-1.03|0.63|||Mixed Models Analysis|||Physical Component Score at Week 26 (Statistical Analysis) -LS mean was determined using MMRM model with Baseline + HbA1c Stratum at Baseline + Country + GLP-1 RA Use at Randomization Flag + SU Use at Randomization Flag + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables.||0.63|-1.03|0.638
72345897|NCT05362058|144214436|SUPERIORITY||LS Mean Difference|-0.32||||0.499|TWO_SIDED|95.0|-1.24|0.6|||Mixed Models Analysis|||Mental Component Score at Week 26 (Statistical Analysis) - LS mean was determined using MMRM model with Baseline + HbA1c Stratum at Baseline + Country + GLP-1 RA Use at Randomization Flag + SU Use at Randomization Flag + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables.||0.60|-1.24|0.499
72345898|NCT05362058|144214436|SUPERIORITY||LS Mean Difference|0.17||||0.695|TWO_SIDED|95.0|-0.68|1.01|||Mixed Models Analysis|||Physical Component Score at Week 52 (Statistical Analysis) - LS mean was determined using MMRM model with Baseline + HbA1c Stratum at Baseline + Country + GLP-1 RA Use at Randomization Flag + SU Use at Randomization Flag + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables.||1.01|-0.68|0.695
72345899|NCT05362058|144214436|SUPERIORITY||LS Mean Difference|-0.23||||0.626|TWO_SIDED|95.0|-1.17|0.71|||Mixed Models Analysis|||Mental Component Score at Week 52 (Statistical Analysis) -LS mean was determined using MMRM model with Baseline + HbA1c Stratum at Baseline + Country + GLP-1 RA Use at Randomization Flag + SU Use at Randomization Flag + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables.||0.71|-1.17|0.626
72345900|NCT05362058|144214437|SUPERIORITY||LS Mean Difference|-0.015||||0.128|TWO_SIDED|95.0|-0.034|0.004|||Mixed Models Analysis|||EQ-5D-5L Health State Index Score at Week 26 (Statistical Analysis) - LS mean was determined using MMRM model with Baseline + HbA1c Stratum at Baseline + Country + GLP-1 RA Use Randomization Flag + SU Use at Randomization Flag + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables.||0.004|-0.034|0.128
72345901|NCT05362058|144214437|SUPERIORITY||LS Mean Difference|-1.11||||0.196|TWO_SIDED|95.0|-2.8|0.58|||Mixed Models Analysis|||EQ VAS Score at Week 26 (Statistical Analysis) - LS mean was determined using MMRM model with Baseline + HbA1c Stratum at Baseline + Country + GLP-1 RA Use Randomization Flag + SU Use at Randomization Flag + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables.||0.58|-2.80|0.196
72345902|NCT05362058|144214437|SUPERIORITY||LS Mean Difference|-0.01||||0.285|TWO_SIDED|95.0|-0.029|0.008|||Mixed Models Analysis|||EQ-5D-5L Health State Index Score at Week 52 (Statistical Analysis) - LS mean was determined using MMRM model with Baseline + HbA1c Stratum at Baseline + Country + GLP-1 RA Use Randomization Flag + SU Use at Randomization Flag + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables.||0.008|-0.029|0.285
72345903|NCT05362058|144214437|SUPERIORITY||LS Mean Difference|-0.35||||0.701|TWO_SIDED|95.0|-2.15|1.44|||Mixed Models Analysis|||EQ VAS Score at Week 52 (Statistical Analysis) - LS mean was determined using MMRM model with Baseline + HbA1c Stratum at Baseline + Country + GLP-1 RA Use Randomization Flag + SU Use at Randomization Flag + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables.||1.44|-2.15|0.701
72345904|NCT00930553|144214457|SUPERIORITY_OR_OTHER||Percentage with SAD|22.33|||||TWO_SIDED|95.0|18.33|27.06|||||The percentage and 95% CI of the participants with SAD are estimated by the Kaplan Meier method.|||27.06|18.33|
72345905|NCT00930553|144214457|SUPERIORITY_OR_OTHER||Percentage with SAD|29.69|||||TWO_SIDED|95.0|25.42|34.49|||||The percentage and 95% CI of the participants with SAD are estimated by the Kaplan Meier method.|||34.49|25.42|
72345906|NCT00930553|144214458|SUPERIORITY_OR_OTHER||Percentage with SAD|9.35|||||TWO_SIDED|95.0|5.54|15.56|||||The percentage and 95% CI of the participants with SAD are estimated by the Kaplan Meier method.|||15.56|5.54|
72345907|NCT00930553|144214458|SUPERIORITY_OR_OTHER||Percentage with SAD|7.95|||||TWO_SIDED|95.0|4.48|13.9|||||The percentage and 95% CI of the participants with SAD are estimated by the Kaplan Meier method.|||13.90|4.48|
72345908|NCT00930553|144214458|SUPERIORITY_OR_OTHER||Percentage with SAD|20.42|||||TWO_SIDED|95.0|14.67|28.03|||||The percentage and 95% CI of the participants with SAD are estimated by the Kaplan Meier method.|||28.03|14.67|
72429007|NCT02404493|144368933|SUPERIORITY_OR_OTHER||||||<|0.001||||||The significance level threshold level was 0.05.|One sample t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||<0.001
72345909|NCT00930553|144214458|SUPERIORITY_OR_OTHER||Percentage with SAD|11.99|||||TWO_SIDED|95.0|7.63|18.58|||||The percentage and 95% CI of the participants with SAD are estimated by the Kaplan Meier method.|||18.58|7.63|
72345910|NCT00930553|144214459|SUPERIORITY_OR_OTHER||Percentage with SRD|32.69|||||TWO_SIDED|95.0|26.96|39.28|||||The percentage and 95% CI of the participants with SRD are estimated by the Kaplan Meier method.|||39.28|26.96|
72345911|NCT00930553|144214459|SUPERIORITY_OR_OTHER||Percentage with SRD|42.46|||||TWO_SIDED|95.0|37.08|48.28|||||The percentage and 95% CI of the participants with SRD are estimated by the Kaplan Meier method.|||48.28|37.08|
72345912|NCT00930553|144214460|SUPERIORITY_OR_OTHER||Percentage with SRD|16.92|||||TWO_SIDED|95.0|9.75|28.47|||||The percentage and 95% CI of the participants with SRD are estimated by the Kaplan Meier method.|||28.47|9.75|
72345913|NCT00930553|144214460|SUPERIORITY_OR_OTHER||Percentage with SRD|13.89|||||TWO_SIDED|95.0|8.47|22.33|||||The percentage and 95% CI of the participants with SRD are estimated by the Kaplan Meier method.|||22.33|8.47|
72345914|NCT04042909|144214499|SUPERIORITY||beta coefficient|-0.309|STANDARD_ERROR_OF_MEAN|0.69||0.646|TWO_SIDED|95.0|-1.632|1.013||This is the p-value of the CAA vs AO factor in the model.|Regression, Linear|We used linear regression, controlling for baseline value of outcome and sex, to determine change in the outcome as a function of condition.||Our main hypothesis is that, relative to Assessment-Only control, the Counter Attitudinal Advocacy intervention will decrease alcohol consumption (drinks per week) from baseline to 6-months.||1.013|-1.632|.646
72345915|NCT04042909|144214500|SUPERIORITY||beta coefficient|-1.9|STANDARD_ERROR_OF_MEAN|0.77||0.014|TWO_SIDED|95.0|-3.41|-0.39|||Regression, Linear|We used regression, controlling for baseline value of outcome and sex, to determine pre-post change in the outcome as a function of condition.||Our main hypothesis is that, relative to Assessment-Only control, the Counter Attitudinal Advocacy intervention will decrease alcohol problems from baseline to 6-months.||-0.39|-3.41|.014
72345916|NCT00286494|144214502|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.47|||<|0.001|TWO_SIDED|95.0|-0.67|-0.28||A step-down strategy was used for the primary analysis. First, the 25mg dose was compared to placebo at the 2-sided 0.05 significance level. The 12.5 mg dose was compared to placebo only if the comparison of the 25mg dose to placebo was significant.|ANCOVA|Treatment, treatment regimen and geographic region as class variables; baseline pioglitazone dose and baseline value for the endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|Null Hypothesis: No difference between treatment and placebo arms in change from baseline in glycosylated hemoglobin at wk 26. Sample size calculated based on normally distributed means. For comparison of either dose vs. placebo (2-sample t-test), study sample size \>=500 subjects had 95% power to detect a treatment difference as small as 0.4% in the supportive per protocol analysis set assuming SD=0.8%, 2-sided \>0.05 significance level and \>=80% of subjects meeting per protocol criteria.||-0.28|-0.67|<0.001
72429008|NCT02404493|144368933|SUPERIORITY_OR_OTHER|||||||0.754||||||The significance level threshold level was 0.05.|One sample t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||0.754
72345917|NCT00286494|144214502|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.61|||<|0.001|TWO_SIDED|95.0|-0.8|-0.41||A step-down strategy was used for the primary analysis. First, the 25mg dose was compared to placebo at the 2-sided 0.05 significance level. The 12.5 mg dose was compared to placebo only if the comparison of the 25mg dose to placebo was significant.|ANCOVA|Treatment, treatment regimen and geographic region as class variables; baseline pioglitazone dose and baseline value for the endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|Null Hypothesis: No difference between treatment and placebo arms in change from baseline in glycosylated hemoglobin at wk 26. Sample size calculated based on normally distributed means. For comparison of either dose vs. placebo (2-sample t-test), study sample size \>=500 subjects had 95% power to detect a treatment difference as small as 0.4% in the supportive per protocol analysis set assuming SD=0.8%, 2-sided \>0.05 significance level and \>=80% of subjects meeting per protocol criteria.||-0.41|-0.80|<0.001
72345918|NCT00286494|144214503|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.26|||<|0.001|TWO_SIDED|95.0|-0.36|-0.16||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.16|-0.36|<0.001
72345919|NCT00286494|144214503|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.31|||<|0.001|TWO_SIDED|95.0|-0.41|-0.21||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.21|-0.41|<0.001
72345920|NCT00286494|144214504|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.42|||<|0.001|TWO_SIDED|95.0|-0.56|-0.27||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.27|-0.56|<0.001
72345921|NCT00286494|144214504|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.55|||<|0.001|TWO_SIDED|95.0|-0.69|-0.4||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.40|-0.69|<0.001
72345922|NCT00286494|144214505|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.46|||<|0.001|TWO_SIDED|95.0|-0.63|-0.3||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.30|-0.63|<0.001
72345923|NCT00286494|144214505|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.59|||<|0.001|TWO_SIDED|95.0|-0.75|-0.43||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.43|-0.75|<0.001
72345924|NCT00286494|144214506|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.45|||<|0.001|TWO_SIDED|95.0|-0.63|-0.26||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.26|-0.63|<0.001
72345925|NCT00286494|144214506|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.58|||<|0.001|TWO_SIDED|95.0|-0.76|-0.4||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.40|-0.76|<0.001
72345926|NCT00286494|144214507|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.41|||<|0.001|TWO_SIDED|95.0|-0.6|-0.22||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.22|-0.60|<0.001
72429009|NCT02404493|144368933|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|52.3|STANDARD_ERROR_OF_MEAN|19.21||0.013|TWO_SIDED|95.0|12.23|92.373||The significance level threshold level was 0.05.|ANCOVA|Change from baseline as response, baseline score as covariate and treatment as factor.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||92.373|12.230|0.013
72345927|NCT00286494|144214507|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.55|||<|0.001|TWO_SIDED|95.0|-0.74|-0.36||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.36|-0.74|<0.001
72345928|NCT00286494|144214508|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.4||||0.003|TWO_SIDED|95.0|-18.9|-3.9||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-3.9|-18.9|0.003
72345929|NCT00286494|144214508|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.5|||<|0.001|TWO_SIDED|95.0|-23.0|-8.0||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-8.0|-23.0|<0.001
72345930|NCT00286494|144214509|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.2|||<|0.001|TWO_SIDED|95.0|-26.4|-11.9||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-11.9|-26.4|<0.001
72345931|NCT00286494|144214509|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.4|||<|0.001|TWO_SIDED|95.0|-26.6|-12.3||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-12.3|-26.6|<0.001
72345932|NCT00286494|144214510|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-20.6|||<|0.001|TWO_SIDED|95.0|-27.5|-13.6||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-13.6|-27.5|<0.001
72345933|NCT00286494|144214510|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-23.0|||<|0.001|TWO_SIDED|95.0|-29.9|-16.0||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-16.0|-29.9|<0.001
72345934|NCT00286494|144214511|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.5|||<|0.001|TWO_SIDED|95.0|-24.4|-8.7||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-8.7|-24.4|<0.001
72345935|NCT00286494|144214511|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-21.1|||<|0.001|TWO_SIDED|95.0|-28.9|-13.3||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-13.3|-28.9|<0.001
72345936|NCT00286494|144214512|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.4||||0.011|TWO_SIDED|95.0|-18.5|-2.4||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-2.4|-18.5|0.011
72345937|NCT00286494|144214512|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.3|||<|0.001|TWO_SIDED|95.0|-24.3|-8.3||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-8.3|-24.3|<0.001
72345938|NCT00286494|144214513|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.0||||0.029|TWO_SIDED|95.0|-18.9|-1.0||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-1.0|-18.9|0.029
72345939|NCT00286494|144214513|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.4||||0.002|TWO_SIDED|95.0|-23.3|-5.5||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-5.5|-23.3|0.002
72429010|NCT02404493|144368934|SUPERIORITY_OR_OTHER||||||<|0.001||||||The significance level threshold level was 0.05.|One sample t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||<0.001
72429011|NCT02404493|144368934|SUPERIORITY_OR_OTHER|||||||0.271||||||The significance level threshold level was 0.05.|One sample t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||0.271
72345940|NCT00286494|144214514|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.6|||<|0.001|TWO_SIDED|95.0|-24.2|-6.9||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-6.9|-24.2|<0.001
72345941|NCT00286494|144214514|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.2|||<|0.001|TWO_SIDED|95.0|-23.8|-6.7||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-6.7|-23.8|<0.001
72345942|NCT00286494|144214515|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.9||||0.003|TWO_SIDED|95.0|-23.1|-4.8||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-4.8|-23.1|0.003
72345943|NCT00286494|144214515|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.1||||0.003|TWO_SIDED|95.0|-23.3|-5.0||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-5.0|-23.3|0.003
72345944|NCT00286494|144214516|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.271|||<|0.001|TWO_SIDED|95.0|0.147|0.499||No multiplicity adjustments.|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline pioglitazone dose, baseline treatment regimen, \& baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||0.499|0.147|<0.001
72345945|NCT00286494|144214516|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.235|||<|0.001|TWO_SIDED|95.0|0.126|0.438||No multiplicity adjustments.|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline pioglitazone dose, baseline treatment regimen, \& baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||0.438|0.126|<0.001
72345946|NCT00286494|144214517|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.628||||0.266|TWO_SIDED|95.0|0.277|1.425||No multiplicity adjustments.|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline pioglitazone dose, baseline treatment regimen \& baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||1.425|0.277|0.266
72345947|NCT00286494|144214517|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.658||||0.315|TWO_SIDED|95.0|0.292|1.487|||Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline pioglitazone dose, baseline treatment regimen \& baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||1.487|0.292|0.315
72345948|NCT00286494|144214518|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.4||||0.003|TWO_SIDED|95.0|-10.6|-2.1||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-2.1|-10.6|0.003
72345949|NCT00286494|144214518|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.9||||0.023|TWO_SIDED|95.0|-9.1|-0.7||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.7|-9.1|0.023
72345950|NCT00286494|144214519|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.2||||0.043|TWO_SIDED|95.0|-8.3|-0.1||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.1|-8.3|0.043
72345951|NCT00286494|144214519|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.4||||0.489|TWO_SIDED|95.0|-5.5|2.6||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||2.6|-5.5|0.489
72345952|NCT00286494|144214520|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.2||||0.068|TWO_SIDED|95.0|-8.8|0.3||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.3|-8.8|0.068
72345953|NCT00286494|144214520|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.4||||0.056|TWO_SIDED|95.0|-8.9|0.1||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.1|-8.9|0.056
72429012|NCT02404493|144368934|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|167.95|STANDARD_ERROR_OF_MEAN|48.21||0.002|TWO_SIDED|95.0|67.046|268.854||The significance level threshold level was 0.05.|ANCOVA|Change from baseline as response, baseline score as covariate and treatment as factor.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||268.854|67.046|0.002
72345954|NCT00286494|144214521|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3||||0.884|TWO_SIDED|95.0|-4.9|4.2||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||4.2|-4.9|0.884
72345955|NCT00286494|144214521|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.993|TWO_SIDED|95.0|-4.5|4.5||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||4.5|-4.5|0.993
72345956|NCT00286494|144214522|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.3||||0.009|TWO_SIDED|95.0|-9.4|-1.3||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-1.3|-9.4|0.009
72345957|NCT00286494|144214522|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.0||||0.143|TWO_SIDED|95.0|-7.0|1.0||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||1.0|-7.0|0.143
72345958|NCT00286494|144214523|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.1||||0.08|TWO_SIDED|95.0|-8.6|0.5||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.5|-8.6|0.080
72345959|NCT00286494|144214523|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6||||0.782|TWO_SIDED|95.0|-5.2|3.9||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||3.9|-5.2|0.782
72345960|NCT00286494|144214524|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.99||||0.249|TWO_SIDED|95.0|-2.68|0.7||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.70|-2.68|0.249
72345961|NCT00286494|144214524|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.88||||0.303|TWO_SIDED|95.0|-2.56|0.8||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.80|-2.56|0.303
72345962|NCT00286494|144214525|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.65||||0.478|TWO_SIDED|95.0|-2.46|1.15||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||1.15|-2.46|0.478
72345963|NCT00286494|144214525|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.38||||0.674|TWO_SIDED|95.0|-1.41|2.17||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||2.17|-1.41|0.674
72345964|NCT00286494|144214526|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.44||||0.743|TWO_SIDED|95.0|-2.18|3.06||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||3.06|-2.18|0.743
72345965|NCT00286494|144214526|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.58||||0.662|TWO_SIDED|95.0|-3.18|2.02||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||2.02|-3.18|0.662
72345966|NCT00286494|144214527|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.75||||0.39|TWO_SIDED|95.0|-0.96|2.45||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||2.45|-0.96|0.390
72345967|NCT00286494|144214527|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.69||||0.423|TWO_SIDED|95.0|-1.0|2.38||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||2.38|-1.00|0.423
72345968|NCT00286494|144214528|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.21||||0.807|TWO_SIDED|95.0|-1.87|1.46||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||1.46|-1.87|0.807
72345969|NCT00286494|144214528|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.14||||0.867|TWO_SIDED|95.0|-1.79|1.51||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||1.51|-1.79|0.867
72345970|NCT00286494|144214529|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.61||||0.483|TWO_SIDED|95.0|-1.1|2.33||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||2.33|-1.10|0.483
72345971|NCT00286494|144214529|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.81||||0.352|TWO_SIDED|95.0|-0.89|2.51||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||2.51|-0.89|0.352
72345972|NCT00286494|144214530|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.057||||0.001|TWO_SIDED|95.0|-0.092|-0.022||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.022|-0.092|0.001
72429013|NCT02404493|144368935|SUPERIORITY_OR_OTHER|||||||0.002||||||The significance level threshold level was 0.05.|One-sample t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||0.002
72429014|NCT02404493|144368935|SUPERIORITY_OR_OTHER|||||||0.26||||||The significance level threshold level was 0.05.|One sample t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||0.260
72345973|NCT00286494|144214530|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.059||||0.001|TWO_SIDED|95.0|-0.093|-0.024||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.024|-0.093|0.001
72345974|NCT00286494|144214531|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.049||||0.006|TWO_SIDED|95.0|-0.084|-0.014||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.014|-0.084|0.006
72345975|NCT00286494|144214531|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.051||||0.004|TWO_SIDED|95.0|-0.086|-0.016||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.016|-0.086|0.004
72345976|NCT00286494|144214532|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.046||||0.05|TWO_SIDED|95.0|-0.092|0.0||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.000|-0.092|0.050
72345977|NCT00286494|144214532|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.057||||0.014|TWO_SIDED|95.0|-0.102|-0.012||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.012|-0.102|0.014
72345978|NCT00286494|144214533|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.027||||0.144|TWO_SIDED|95.0|-0.064|0.009||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.009|-0.064|0.144
72345979|NCT00286494|144214533|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.03||||0.105|TWO_SIDED|95.0|-0.067|0.006||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.006|-0.067|0.105
72345980|NCT00286494|144214534|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.059||||0.004|TWO_SIDED|95.0|-0.1|-0.019||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.019|-0.100|0.004
72345981|NCT00286494|144214534|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.051||||0.012|TWO_SIDED|95.0|-0.092|-0.011||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.011|-0.092|0.012
72345982|NCT00286494|144214535|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.05||||0.028|TWO_SIDED|95.0|-0.095|-0.005||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.005|-0.095|0.028
72345983|NCT00286494|144214535|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.038||||0.093|TWO_SIDED|95.0|-0.082|0.006||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.006|-0.082|0.093
72345984|NCT00286494|144214536|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.012||||0.928|TWO_SIDED|95.0|-0.28|0.255||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.255|-0.280|0.928
72345985|NCT00286494|144214536|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.056||||0.683|TWO_SIDED|95.0|-0.212|0.324||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.324|-0.212|0.683
72429015|NCT02404493|144368935|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|221.97|STANDARD_ERROR_OF_MEAN|100.674||0.04|TWO_SIDED|95.0|11.254|432.68||The significance level threshold level was 0.05.|ANCOVA|Change from baseline as response, baseline score as covariate and treatment as factor.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||432.680|11.254|0.040
72429016|NCT02404493|144368936|SUPERIORITY_OR_OTHER||||||<|0.001||||||The significance level threshold level was 0.05.|One sample t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||<0.001
72429017|NCT02404493|144368936|SUPERIORITY_OR_OTHER|||||||0.22||||||The significance level threshold level was 0.05.|One sample t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||0.220
72345986|NCT00286494|144214537|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.006||||0.967|TWO_SIDED|95.0|-0.277|0.265||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.265|-0.277|0.967
72345987|NCT00286494|144214537|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.135||||0.327|TWO_SIDED|95.0|-0.135|0.405||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.405|-0.135|0.327
72345988|NCT00286494|144214538|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.068||||0.649|TWO_SIDED|95.0|-0.363|0.226||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.226|-0.363|0.649
72345989|NCT00286494|144214538|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.051||||0.735|TWO_SIDED|95.0|-0.344|0.243||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.243|-0.344|0.735
72345990|NCT00286494|144214539|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.22||||0.114|TWO_SIDED|95.0|-0.053|0.492||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.492|-0.053|0.114
72345991|NCT00286494|144214539|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.238||||0.086|TWO_SIDED|95.0|-0.033|0.51||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.510|-0.033|0.086
72345992|NCT00286494|144214540|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.026||||0.835|TWO_SIDED|95.0|-0.221|0.273||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.273|-0.221|0.835
72345993|NCT00286494|144214540|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.131||||0.296|TWO_SIDED|95.0|-0.115|0.378||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.378|-0.115|0.296
72345994|NCT00286494|144214541|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.123||||0.349|TWO_SIDED|95.0|-0.134|0.38||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.380|-0.134|0.349
72345995|NCT00286494|144214541|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.223||||0.089|TWO_SIDED|95.0|-0.034|0.479||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.479|-0.034|0.089
72345996|NCT00286494|144214542|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.815||||0.003|TWO_SIDED|95.0|1.736|13.358|||Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline pioglitazone dose, baseline treatment regimen \& baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||13.358|1.736|0.003
72345997|NCT00286494|144214542|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.533|||<|0.001|TWO_SIDED|95.0|2.017|15.176|||Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline pioglitazone dose, baseline treatment regimen \& baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||15.176|2.017|<0.001
72345998|NCT00286494|144214543|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.903||||0.029|TWO_SIDED|95.0|1.067|3.393|||Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline pioglitazone dose, baseline treatment regimen \& baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||3.393|1.067|0.029
72345999|NCT00286494|144214543|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.301||||0.005|TWO_SIDED|95.0|1.291|4.1|||Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline pioglitazone dose, baseline treatment regiment \& baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||4.100|1.291|0.005
72346000|NCT00286494|144214544|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.783|||<|0.001|TWO_SIDED|95.0|1.547|5.005|||Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline pioglitazone dose, baseline treatment regimen \& baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||5.005|1.547|<0.001
72346001|NCT00286494|144214544|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.917|||<|0.001|TWO_SIDED|95.0|2.147|7.146|||Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline pioglitazone dose, baseline treatment regimen \& baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||7.146|2.147|<0.001
72346002|NCT00286494|144214545|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.134|||<|0.001|TWO_SIDED|95.0|2.392|7.146|||Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline pioglitazone dose, baseline treatment regimen \& baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||7.146|2.392|<0.001
72346003|NCT00286494|144214545|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.247|||<|0.001|TWO_SIDED|95.0|3.027|9.094|||Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline pioglitazone dose, baseline treatment regimen \& baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||9.094|3.027|<0.001
72346004|NCT00286494|144214546|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.67|||<|0.001|TWO_SIDED|95.0|1.789|7.532|||Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline pioglitazone dose, baseline treatment regimen \& baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||7.532|1.789|<0.001
72346005|NCT00286494|144214546|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.693|||<|0.001|TWO_SIDED|95.0|2.303|9.56|||Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline pioglitazone dose, baseline treatment regimen \& baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||9.560|2.303|<0.001
72346006|NCT00286494|144214547|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.8||||0.015|TWO_SIDED|95.0|1.3|11.107|||Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline pioglitazone dose, baseline treatment regimen \& baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||11.107|1.300|0.015
72346007|NCT00286494|144214547|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.196||||0.002|TWO_SIDED|95.0|1.806|14.95|||Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline pioglitazone dose, baseline treatment regimen \& baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||14.950|1.806|0.002
72346008|NCT00286494|144214548|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.959||||0.364|TWO_SIDED|95.0|0.459|8.362|||Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline pioglitazone dose, baseline treatment regimen \& baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||8.362|0.459|0.364
72346009|NCT00286494|144214548|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.849||||0.146|TWO_SIDED|95.0|0.696|11.672|||Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline pioglitazone dose, baseline treatment regimen \& baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||11.672|0.696|0.146
72346010|NCT00286494|144214549|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||0.718|TWO_SIDED|95.0|-0.45|0.65||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose,baseline value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.65|-0.45|0.718
72346011|NCT00286494|144214549|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.03||||0.906|TWO_SIDED|95.0|-0.52|0.58||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.58|-0.52|0.906
72346012|NCT00286494|144214550|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.14||||0.672|TWO_SIDED|95.0|-0.5|0.78||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.78|-0.50|0.672
72346013|NCT00286494|144214550|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.03||||0.922|TWO_SIDED|95.0|-0.61|0.67||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.67|-0.61|0.922
72346014|NCT00286494|144214551|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2||||0.607|TWO_SIDED|95.0|-0.56|0.96||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.96|-0.56|0.607
72346015|NCT00286494|144214551|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01||||0.985|TWO_SIDED|95.0|-0.77|0.76||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.76|-0.77|0.985
72346016|NCT00286494|144214552|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.42||||0.294|TWO_SIDED|95.0|-0.37|1.22||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||1.22|-0.37|0.294
72346017|NCT00286494|144214552|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.05||||0.9|TWO_SIDED|95.0|-0.74|0.84||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.84|-0.74|0.900
72346018|NCT02524158|144214696|SUPERIORITY|||||||0.34|||||||Mixed Models Analysis|||||||0.340
72346019|NCT02524158|144214697|SUPERIORITY|||||||0.003|||||||Mixed Models Analysis|||||||0.003
72346020|NCT02524158|144214698|SUPERIORITY|||||||0.005||||||The a priori specified threshold is p \< 0.05|Mixed Models Analysis|||||||0.005
72346021|NCT02524158|144214699|SUPERIORITY|||||||0.013|||||||Mixed Models Analysis|||||||0.013
72346022|NCT02524158|144214700|SUPERIORITY|||||||0.044||||||The a priori specified threshold is p \< 0.05|ANCOVA|||||||0.044
72346023|NCT02524158|144214701|SUPERIORITY||||||<|0.01|||||||ANCOVA|||||||<0.01
72346024|NCT02524158|144214702|SUPERIORITY|||||||0.01||||||The a priori specified threshold is p \< 0.05|ANCOVA|||||||0.010
72346025|NCT02524158|144214703|SUPERIORITY|||||||0.66|||||||ANCOVA|||||||0.66
72346026|NCT02524158|144214704|SUPERIORITY||||||<|0.1|||||||Mixed Models Analysis|||||||<0.10
72346027|NCT02524158|144214705|SUPERIORITY|||||||0.202|||||||ANCOVA|||||||0.202
72346028|NCT02524158|144214706|SUPERIORITY|||||||0.369|||||||ANCOVA|||||||0.369
72346029|NCT02524158|144214707|SUPERIORITY|||||||0.5|||||||ANCOVA|||||||0.50
72346030|NCT02524158|144214708|SUPERIORITY|||||||0.067|||||||ANCOVA|||||||0.067
72346031|NCT02524158|144214710|SUPERIORITY|||||||0.071|||||||ANCOVA|||||||0.071
72346032|NCT02524158|144214711|SUPERIORITY|||||||0.92|||||||ANCOVA|||||||0.92
72346033|NCT02524158|144214712|SUPERIORITY|||||||0.036||||||The a priori specified threshold is p \< 0.05|ANCOVA|||||||0.036
72346034|NCT02524158|144214713|SUPERIORITY|||||||0.071|||||||ANCOVA|||||||0.071
72346035|NCT00596830|144214726|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.179||||0.064|TWO_SIDED|95.0|0.99|1.404||The p-value stated is the 2-sided p-value from the log rank test stratified by gender, prior adjuvant chemotherapy, and histology.|Log Rank|||||1.404|0.990|0.064
72346036|NCT00596830|144214727|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.103||||0.27|TWO_SIDED|95.0|0.925|1.315||2-sided p-value is from the unstratified log-rank test|Log Rank||HR was based on the Cox proportional hazards model|||1.315|0.925|0.270
72346037|NCT00596830|144214728|SUPERIORITY_OR_OTHER||Risk difference|-1.472||||0.685|TWO_SIDED|95.0|-8.6|5.6|||Chi-squared||Risk difference confidence interval was calculated based on a normal distribution.|||5.6|-8.6|0.685
72346038|NCT01919801|144214736|SUPERIORITY_OR_OTHER_LEGACY|||||||0.633||||||Test was performed using a weighted log-rank test called the Peto-Prentice test with a global 2-sided significance level of 5% after adjusting for stratification factors (race, and severity) in the ITT population.|Adjusted Peto-Prentice|||A total of 121 participants were analysed, however 3 participants did not receive the study medication and were censored at time 0.||||0.633
72346039|NCT01843062|144214746|SUPERIORITY||Odds Ratio (OR)|1.07||||0.8205|TWO_SIDED|95.0|0.61|1.87||The primary endpoint was to be considered statistically significant if the 2-sided p-value was less than 0.05. P-value and confidence intervals (CIs) were calculated using profile likelihood.|Regression, Logistic|||Selumetinib in combination with RAI was compared with placebo in combination with RAI. The analysis was performed using a logistic regression model including treatment as the only covariate. An odds ratio \>1 favours selumetinib in combination with RAI.||1.87|0.61|0.8205
72346040|NCT01843062|144214747|SUPERIORITY||Odds Ratio (OR)|0.85||||0.6549|TWO_SIDED|95.0|0.42|1.73||P-value and CIs were calculated using profile likelihood.|Regression, Logistic|||Selumetinib in combination with RAI was compared with placebo in combination with RAI. The analysis was performed using a logistic regression model including treatment as the only covariate. An odds ratio \>1 favours selumetinib in combination with RAI.||1.73|0.42|0.6549
72346041|NCT01843062|144214748|SUPERIORITY||Odds Ratio (OR)|1.07||||0.8205|TWO_SIDED|95.0|0.61|1.87||P-value and CIs were calculated using profile likelihood.|Regression, Logistic|||Selumetinib in combination with RAI was compared with placebo in combination with RAI. The analysis was performed using a logistic regression model including treatment as the only covariate. An odds ratio \>1 favours selumetinib in combination with RAI.||1.87|0.61|0.8205
72346042|NCT01843062|144214749|SUPERIORITY||Odds Ratio (OR)|0.85||||0.6549|TWO_SIDED|95.0|0.42|1.73||P-value and CIs were calculated using profile likelihood.|Regression, Logistic|||Selumetinib in combination with RAI was compared with placebo in combination with RAI. The analysis was performed using a logistic regression model including treatment as the only covariate. An odds ratio \>1 favours selumetinib in combination with RAI.||1.73|0.42|0.6549
72346043|NCT01677858|144214750|OTHER||Maximum Tolerated Dose (mg/m²)|70.0|||||TWO_SIDED|||||||||||||
72346044|NCT03549104|144214779|OTHER||||||||||||||||||We will evaluate the effects of within-group and between-group differences from baseline (Week 0) to program completion (Week 8) to calculate effect sizes for sample size estimation for a future larger study.|||
72346045|NCT03549104|144214780|OTHER||||||||||||||||||We will evaluate the effects of within-group and between-group differences from baseline (Week 0) to program completion (Week 8) to calculate effect sizes for sample size estimation for a future larger study.|||
72346046|NCT03549104|144214781|OTHER||||||||||||||||||We will evaluate the effects of within-group and between-group differences from baseline (Week 0) to program completion (Week 8) to calculate effect sizes for sample size estimation for a future larger study.|||
72346047|NCT01457846|144214801|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.57||||0.9581|TWO_SIDED|80.0|1.12|2.21||1-sided|Regression, Cox|||||2.21|1.12|0.9581
72346048|NCT01457846|144214802|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.31||||0.8156|TWO_SIDED|80.0|0.89|1.95||1-sided|Regression, Cox|||||1.95|0.89|0.8156
72346049|NCT01457846|144214803|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.09||||0.997|TWO_SIDED|80.0|0.02|0.35||1-sided|Regression, Logistic|||||0.35|0.02|0.9970
72346050|NCT02161757|144214806|SUPERIORITY|The null hypothesis was that the exacerbation rate during the 52-week double-blind treatment period on tralokinumab was equal to the corresponding exacerbation rate on placebo.|Rate ratio|0.93||||0.5859|TWO_SIDED|95.0|0.72|1.21|||Negative binomial||Covariates in the model included treatment group, geographical region, age group, periostin group at baseline and number of exacerbations in the year before the study.|Comparison of AAER (rate ratio): Tralo 300 mg Q2W vs placebo.||1.21|0.72|0.5859
72346051|NCT02161757|144214806|SUPERIORITY|The null hypothesis was that the exacerbation rate during the 52-week double-blind treatment period on tralokinumab was equal to the corresponding exacerbation rate on placebo.|Rate ratio|0.9||||0.4406|TWO_SIDED|95.0|0.7|1.17|||Negative binomial||Covariates in the model included treatment group, geographical region, age group, periostin group at baseline and number of exacerbations in the year before the study.|Comparison of AAER (rate ratio): Tralo 300 mg Q4W vs placebo.||1.17|0.70|0.4406
72346052|NCT02161757|144214806|SUPERIORITY|The null hypothesis was that the exacerbation rate during the 52-week double-blind treatment period on tralokinumab was equal to the corresponding exacerbation rate on placebo.|Rate reduction|7.01||||0.5859|TWO_SIDED|95.0|-20.76|28.39|||Negative binominal||Covariates in the model included treatment group, geographical region, age group, periostin group at baseline and number of exacerbations in the year before the study.|Comparison of AAER (rate reduction): Tralo 300 mg Q2W vs placebo.||28.39|-20.76|0.5859
72346053|NCT02161757|144214806|SUPERIORITY|The null hypothesis was that the exacerbation rate during the 52-week double-blind treatment period on tralokinumab was equal to the corresponding exacerbation rate on placebo.|Rate reduction|9.76||||0.4406|TWO_SIDED|95.0|-17.16|30.5|||Negative binominal||Covariates in the model included treatment group, geographical region, age group, periostin group at baseline and number of exacerbations in the year before the study.|Comparison of AAER (rate reduction): Tralo 300 mg Q4W vs placebo.||30.50|-17.16|0.4406
72346054|NCT02161757|144214807|SUPERIORITY||Least square (LS) Mean difference|6.03|||||TWO_SIDED|95.0|2.34|9.73|||||Fixed categorical effects of treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as a fixed covariate.|"Comparison of percent change from baseline in pre-dose/pre-BD FEV1 at Week 52: Tralo 300 mg Q2W vs placebo.~Restricted maximum likelihood (REML) based repeated measures analysis performed on patients with a baseline pre-dose/pre-BD FEV1 assessment."||9.73|2.34|
72346055|NCT02161757|144214807|SUPERIORITY||LS Mean difference|2.1|||||TWO_SIDED|95.0|-1.58|5.77|||||Fixed categorical effects of treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as a fixed covariate.|"Comparison of percent change from baseline in pre-dose/pre-BD FEV1 at Week 52: Tralo 300 mg Q4W vs placebo.~REML based repeated measures analysis performed on patients with a baseline pre-dose/pre-BD FEV1 assessment."||5.77|-1.58|
72346056|NCT02161757|144214808|SUPERIORITY||LS Mean difference|-0.09|||||TWO_SIDED|95.0|-0.23|0.04|||||Fixed categorical effects of baseline asthma symptom score, treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as a fixed covariate.|"Comparison of mean change from baseline in total asthma symptom score at Week 52: Tralo 300 mg Q2W vs placebo.~REML based repeated measures analysis."||0.04|-0.23|
72346057|NCT02161757|144214808|SUPERIORITY||LS Mean difference|-0.02|||||TWO_SIDED|95.0|-0.15|0.12|||||Fixed categorical effects of baseline asthma symptom score, treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as a fixed covariate.|"Comparison of mean change from baseline in total asthma symptom score at Week 52: Tralo 300 mg Q4W vs placebo.~REML based repeated measures analysis."||0.12|-0.15|
72346058|NCT02161757|144214809|SUPERIORITY||LS Mean difference|0.15|||||TWO_SIDED|95.0|-0.01|0.31|||||Fixed categorical effects of baseline AQLQ(S)+12 score, treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as a fixed covariate.|"Comparison of change in mean score from baseline for AQLQ(S)+12 at Week 52: Tralo 300 mg Q2W vs placebo.~REML based repeated measures analysis."||0.31|-0.01|
72346059|NCT02161757|144214809|SUPERIORITY||LS Mean difference|0.12|||||TWO_SIDED|95.0|-0.03|0.28|||||Fixed categorical effects of baseline AQLQ(S)+12 score, treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as a fixed covariate.|"Comparison of change in mean score from baseline for AQLQ(S)+12 at Week 52: Tralo 300 mg Q4W vs placebo.~REML based repeated measures analysis."||0.28|-0.03|
72346060|NCT02161757|144214810|SUPERIORITY||LS Mean difference|-0.16|||||TWO_SIDED|95.0|-0.29|-0.02|||||Fixed categorical effects of baseline ACQ-6 score, treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as a fixed covariate.|"Comparison of change in mean score from baseline for ACQ-6 at Week 52: Tralo 300 mg Q2W vs placebo.~REML based repeated measures analysis."||-0.02|-0.29|
72346061|NCT02161757|144214810|SUPERIORITY||LS Mean difference|-0.12|||||TWO_SIDED|95.0|-0.26|0.01|||||Fixed categorical effects of baseline ACQ-6 score, treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as a fixed covariate.|"Comparison of change in mean score from baseline for ACQ-6 at Week 52: Tralo 300 mg Q4W vs placebo.~REML based repeated measures analysis."||0.01|-0.26|
72346062|NCT02161757|144214811|SUPERIORITY||Rate ratio|0.54||||0.0369|TWO_SIDED|95.0|0.3|0.96|||Negative binomial||Covariates in the model included treatment group, geographical region, age group, periostin group at baseline and number of exacerbations resulting in hospitalisation or ER treatment (yes/no) in the year before the study.|Comparison of AAER associated with an ER/UC visit or hospitalisation: Tralo 300 mg Q2W vs placebo.||0.96|0.30|0.0369
72346063|NCT02161757|144214811|SUPERIORITY||Rate ratio|0.78||||0.3603|TWO_SIDED|95.0|0.46|1.33|||Negative binomial||Covariates in the model included treatment group, geographical region, age group, periostin group at baseline and number of exacerbations resulting in hospitalisation or ER treatment (yes/no) in the year before the study.|Comparison of AAER associated with an ER/UC visit or hospitalisation: Tralo 300 mg Q4W vs placebo.||1.33|0.46|0.3603
72346064|NCT02161757|144214813|SUPERIORITY||LS Mean difference|-0.11|||||TWO_SIDED|95.0|-0.51|0.29|||||Fixed categorical effects of baseline rescue medication use, treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as a fixed covariate.|Comparison of mean change from baseline in rescue medication use at Week 52: Tralo 300 mg Q2W vs placebo. REML based repeated measures analysis.||0.29|-0.51|
72346065|NCT02161757|144214813|SUPERIORITY||LS Mean difference|-0.16|||||TWO_SIDED|95.0|-0.56|0.24|||||Fixed categorical effects of baseline rescue medication use, treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as a fixed covariate.|Comparison of mean change from baseline in rescue medication use at Week 52: Tralo 300 mg Q4W vs placebo. REML based repeated measures analysis.||0.24|-0.56|
72429018|NCT02404493|144368936|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|194.0|STANDARD_ERROR_OF_MEAN|68.461||0.011|TWO_SIDED|95.0|50.712|337.291||The significance level threshold level was 0.05.|ANCOVA|Change from baseline as response, baseline score as covariate and treatment as factor.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||337.291|50.712|0.011
72346066|NCT02161757|144214814|SUPERIORITY||LS Mean difference|6.25|||||TWO_SIDED|95.0|-3.53|16.03|||||Fixed categorical effects of baseline PEF (morning), treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as a fixed covariate.|"Comparison of mean change from baseline in morning PEF at Week 52: Tralo 300 mg Q2W vs placebo.~REML based repeated measures analysis."||16.03|-3.53|
72346067|NCT02161757|144214814|SUPERIORITY||LS Mean difference|1.77|||||TWO_SIDED|95.0|-7.99|11.53|||||Fixed categorical effects of baseline PEF (morning), treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as a fixed covariate.|"Comparison of mean change from baseline in morning PEF at Week 52: Tralo 300 mg Q4W vs placebo.~REML based repeated measures analysis."||11.53|-7.99|
72346068|NCT02161757|144214814|SUPERIORITY||LS Mean difference|7.14|||||TWO_SIDED|95.0|-2.6|16.87|||||Fixed categorical effects of baseline PEF (evening), treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as a fixed covariate.|"Comparison of mean change from baseline in evening PEF at Week 52: Tralo 300 mg Q2W vs placebo.~REML based repeated measures analysis."||16.87|-2.60|
72346069|NCT02161757|144214814|SUPERIORITY||LS Mean difference|0.61|||||TWO_SIDED|95.0|-9.13|10.35|||||Fixed categorical effects of baseline PEF (evening), treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as a fixed covariate.|"Comparison of mean change from baseline in evening PEF at Week 52: Tralo 300 mg Q4W vs placebo.~REML based repeated measures analysis."||10.35|-9.13|
72346070|NCT02161757|144214815|SUPERIORITY||LS Mean difference|-1.8|||||TWO_SIDED|95.0|-5.29|1.69|||||Fixed categorical effects of baseline number (%) of awakenings, treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as a fixed covariate.|"Comparison of mean change from baseline in number (%) of awakenings at Week 52: Tralo 300 mg Q2W vs placebo.~REML based repeated measures analysis."||1.69|-5.29|
72346071|NCT02161757|144214815|SUPERIORITY||LS Mean difference|-2.36|||||TWO_SIDED|95.0|-5.84|1.12|||||Fixed categorical effects of baseline number (%) of awakenings, treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as a fixed covariate.|"Comparison of mean change from baseline in number (%) of awakenings at Week 52: Tralo 300 mg Q4W vs placebo.~REML based repeated measures analysis."||1.12|-5.84|
72346072|NCT02161757|144214816|SUPERIORITY||Odds Ratio (OR)|0.95||||0.732|TWO_SIDED|95.0|0.71|1.28|||Cochran-Mantel-Haenszel||The estimate of each odds ratio was obtained from two separate models, from a Cochran-Mantel-Haenszel test controlling for geographical region, age group and periostin group at baseline.|Comparison of number of patients with ≥ 1 asthma exacerbations up to Week 52: Tralo 300 mg Q2W vs placebo.||1.28|0.71|0.732
72346073|NCT02161757|144214816|SUPERIORITY||Odds Ratio (OR)|0.88||||0.421|TWO_SIDED|95.0|0.65|1.19|||Cochran-Mantel-Haenszel||The estimate of each odds ratio was obtained from two separate models, from a Cochran-Mantel-Haenszel test controlling for geographical region, age group and periostin group at baseline.|Comparison of number of patients with ≥ 1 asthma exacerbations up to Week 52: Tralo 300 mg Q4W vs placebo.||1.19|0.65|0.421
72346074|NCT01007838|144214869|SUPERIORITY_OR_OTHER|||||||0.3||95.0||||Statistical significance was accepted if p \< 0.05.|ANCOVA|||Omnibus ANCOVA. An interaction would suggests patients responded to exercise differently than controls||||0.30
72346075|NCT01007838|144214869|SUPERIORITY_OR_OTHER|||||||0.0017||95.0||||Statistical significance was accepted if p \< 0.05.|ANOVA|||Follow up ANOVA in chronic kideny disease patients only. An interaction would suggest patients allocated to the resistance exercise group increased muscle size more than those allocated to the sham exercise group.||||0.0017
72346076|NCT01007838|144214869|SUPERIORITY_OR_OTHER|||||||0.024||95.0||||Statistical sigficance was accepted if p \< 0.05.|ANOVA|||Follow up ANOVA in healthy controls only. An interaction would suggest healthy controls allocated to the resistance exercise group increased muscle size more than those allocated to the sham exercise group.||||0.024
72346077|NCT04167137|144214871|OTHER|||||||||||||||||Because only 1 participant experienced a DLT (Grade 3 cytokine release syndrome in Arm 1 Cohort 6), no MTD could be reached.|Because only 1 participant experienced a DLT (Grade 3 cytokine release syndrome in Arm 1 Cohort 6), no MTD could be reached.|||
72346078|NCT00118430|144214920|SUPERIORITY_OR_OTHER||||||<|0.001||||||This reported p-value was calculated (and does not merely represent the threshold for significance.|Mixed Models Analysis|||||||<0.001
72346079|NCT00118430|144214921|SUPERIORITY_OR_OTHER||||||<|0.001||||||This reported p-value was calculated (and does not merely represent the threshold for significance.|Mixed Models Analysis|||||||< 0.001
72346080|NCT00118430|144214922|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
72346081|NCT00118430|144214923|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Poisson|||||||<0.001
72346082|NCT04412707|144214938|EQUIVALENCE|The condition for similarity was if the 90% CI for the GMR was within the bioequivalence limits of 0.8 and 1.25.|Adjusted geometric mean ratio (GMR)|0.946|||||TWO_SIDED|90.0|0.849|1.053|||||CVC vs. PVC, where CVC is numerator and PVC is denominator. Linear Mixed Effect Model included terms for period, sequence and administration route (PVC or CVC) as fixed effects and subject nested within sequence as a random effect.|Based on a geometric mean ratio (GMR) peripheral vs. central of 0.95, a 90% confidence interval (CI) for the ratio of geometric means within bioequivalence limits of 0.8 and 1.25, and 80% power, a sample size of 20 patients (10 per sequence) was required assuming a within-patient variability for period differences (in log scale) of 0.29. Approximately 25 patients were to be enrolled to achieve 20 PK- and local tolerance-evaluable patients.||1.053|0.849|
72346083|NCT04412707|144214939|EQUIVALENCE|The condition for similarity was if the 90% CI for the GMR was within the bioequivalence limits of 0.8 and 1.25.|Adjusted geometric mean ratio (GMR)|0.952|||||TWO_SIDED|90.0|0.861|1.053|||||CVC vs. PVC, where CVC is numerator and PVC is denominator. Linear Mixed Effect Model included terms for period, sequence and administration route (PVC or CVC) as fixed effects and subject nested within sequence as a random effect.|Based on a geometric mean ratio (GMR) peripheral vs. central of 0.95, a 90% confidence interval (CI) for the ratio of geometric means within bioequivalence limits of 0.8 and 1.25, and 80% power, a sample size of 20 patients (10 per sequence) was required assuming a within-patient variability for period differences (in log scale) of 0.29. Approximately 25 patients were to be enrolled to achieve 20 PK- and local tolerance-evaluable patients.||1.053|0.861|
72346084|NCT04412707|144214940|EQUIVALENCE|The condition for similarity was if the 90% CI for the GMR was within the bioequivalence limits of 0.8 and 1.25.|Adjusted geometric mean ratio (GMR)|0.955|||||TWO_SIDED|90.0|0.863|1.058|||||CVC vs. PVC, where CVC is numerator and PVC is denominator. Linear Mixed Effect Model included terms for period, sequence and administration route (PVC or CVC) as fixed effects and subject nested within sequence as a random effect.|Based on a geometric mean ratio (GMR) peripheral vs. central of 0.95, a 90% confidence interval (CI) for the ratio of geometric means within bioequivalence limits of 0.8 and 1.25, and 80% power, a sample size of 20 patients (10 per sequence) was required assuming a within-patient variability for period differences (in log scale) of 0.29. Approximately 25 patients were to be enrolled to achieve 20 PK- and local tolerance-evaluable patients.||1.058|0.863|
72346085|NCT04412707|144214942|EQUIVALENCE|The condition for similarity was if the 90% CI for the GMR was within the bioequivalence limits of 0.8 and 1.25.|adjusted geometric mean ratio (GMR)|0.948|||||TWO_SIDED|90.0|0.736|1.222|||||CVC vs PVC CVC is numerator and PVC is denominator. Linear Mixed Effect Model included terms for period, sequence and administration route (PVC or CVC) as fixed effects and subject nested within sequence as a random effect.|For melflufen: Based on a geometric mean ratio (GMR) peripheral vs central of 0.95, a 90% confidence interval (CI) for the ratio of geometric means within bioequivalence limits of 0.8 and 1.25, and 80% power, a sample size of 20 patients (10 per sequence) was required assuming a within-patient variability for period differences (in log scale) of 0.29. Approximately 25 patients were to be enrolled to achieve 20 PK- and local tolerance-evaluable patients.||1.222|0.736|
72346086|NCT04412707|144214942|EQUIVALENCE|The condition for similarity was if the 90% CI for the GMR was within the bioequivalence limits of 0.8 and 1.25.|[adjusted geometric mean ratio (GMR)]|0.846|||||TWO_SIDED|90.0|0.748|0.957|||||CVC vs PVC CVC is numerator and PVC is denominator. Linear Mixed Effect Model included terms for period, sequence and administration route (PVC or CVC) as fixed effects and subject nested within sequence as a random effect.|For desmethyl-melflufen: Based on a geometric mean ratio (GMR) peripheral vs central of 0.95, a 90% confidence interval (CI) for the ratio of geometric means within bioequivalence limits of 0.8 and 1.25, and 80% power, a sample size of 20 patients (10 per sequence) was required assuming a within-patient variability for period differences (in log scale) of 0.29. Approximately 25 patients were to be enrolled to achieve 20 PK- and local tolerance-evaluable patients.||0.957|0.748|
72346087|NCT04412707|144214943|EQUIVALENCE|The condition for similarity was if the 90% CI for the GMR was within the bioequivalence limits of 0.8 and 1.25.|adjusted geometric mean ratio (GMR)|0.877|||||TWO_SIDED|90.0|0.684|1.126|||||Data above refer to meflufen. CVC vs PVC CVC is numerator, PVC is denominator. Linear Mixed Effect Model included terms for period, sequence and administration route (PVC or CVC) as fixed effects and subject nested within sequence as a random effect.|Based on a geometric mean ratio (GMR) peripheral vs central of 0.95, a 90% confidence interval (CI) for the ratio of geometric means within bioequivalence limits of 0.8 and 1.25, and 80% power, a sample size of 20 patients (10 per sequence) was required assuming a within-patient variability for period differences (in log scale) of 0.29. Approximately 25 patients were to be enrolled to achieve 20 PK- and local tolerance-evaluable patients.||1.126|0.684|
72346088|NCT04412707|144214943|EQUIVALENCE|The condition for similarity was if the 90% CI for the GMR was within the bioequivalence limits of 0.8 and 1.25.|adjusted geometric mean ratio (GMR)|0.897|||||TWO_SIDED|90.0|0.819|0.982|||||Data above refer to desethyl-melflufen. CVC vs PVC CVC is numerator, PVC is denominator. Linear Mixed Effect Model included terms for period, sequence and administration route as fixed effects and subject nested within sequence as a random effect.|Based on a geometric mean ratio (GMR) peripheral vs central of 0.95, a 90% confidence interval (CI) for the ratio of geometric means within bioequivalence limits of 0.8 and 1.25, and 80% power, a sample size of 20 patients (10 per sequence) was required assuming a within-patient variability for period differences (in log scale) of 0.29. Approximately 25 patients were to be enrolled to achieve 20 PK- and local tolerance-evaluable patients.||0.982|0.819|
72346089|NCT04412707|144214944|EQUIVALENCE|The condition for similarity was if the 90% CI for the GMR was within the bioequivalence limits of 0.8 and 1.25.|adjusted geometric mean ratio (GMR)|0.877|||||TWO_SIDED|90.0|0.684|1.124|||||Data above refer to melflufen. CVC vs PVC CVC is numerator, PVC is denominator. Linear Mixed Effect Model included terms for period, sequence \& administration route (PVC or CVC) as fixed effects and subject nested within sequence as a random effect.|Based on a geometric mean ratio (GMR) peripheral vs central of 0.95, a 90% confidence interval (CI) for the ratio of geometric means within bioequivalence limits of 0.8 and 1.25, and 80% power, a sample size of 20 patients (10 per sequence) was required assuming a within-patient variability for period differences (in log scale) of 0.29. Approximately 25 patients were to be enrolled to achieve 20 PK- and local tolerance-evaluable patients.||1.124|0.684|
72346090|NCT04412707|144214944|EQUIVALENCE|The condition for similarity was if the 90% CI for the GMR was within the bioequivalence limits of 0.8 and 1.25.|adjusted geometric mean ratio (GMR)|0.908|||||TWO_SIDED|90.0|0.833|0.989|||||Data above refer to desethyl-melflufen. CVC vs PVC CVC is numerator, PVC is denominator. Linear Mixed Effect Model included terms for period, sequence \& administration route as fixed effects and subject nested within sequence as a random effect.|Based on a geometric mean ratio (GMR) peripheral vs central of 0.95, a 90% confidence interval (CI) for the ratio of geometric means within bioequivalence limits of 0.8 and 1.25, and 80% power, a sample size of 20 patients (10 per sequence) was required assuming a within-patient variability for period differences (in log scale) of 0.29. Approximately 25 patients were to be enrolled to achieve 20 PK- and local tolerance-evaluable patients.||0.989|0.833|
72346091|NCT00997594|144214972|NON_INFERIORITY_OR_EQUIVALENCE|Just a comparison of the percentage of hypertension between the 2 patient groups.|||||<|0.05||95.0|||||Chi-squared, Corrected|||||||<0.05
72346092|NCT02391363|144215017|SUPERIORITY|||||||0.77||||||P-value for treatment-group effect (CL vs ECC)|ANCOVA|Treatment group F = 0.08 (Numerator df = 1, Denominator df varies, as multiple imputation was used).||"Analyses were ITT using PROC MI and PROC MI ANALYZE in conjunction with ANCOVA. We expected to reject the null hypothesis of no treatment group difference in 6 month PSWQ-A, controlling for baseline PSWQ-A.~Race/ethnicity and ERS-expectancies significantly differed between groups at baseline and were included as covariates.~A total of 134 participants allowed for 80% power to detect moderate group differences (d=.49) in primary and secondary outcomes given a 2-tailed type 1 error rate of .05."||||0.77
72429019|NCT02404493|144368937|SUPERIORITY_OR_OTHER|||||||0.002||||||The significance level threshold level was 0.05.|One sample t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||0.002
72346093|NCT02391363|144215018|SUPERIORITY|||||||0.07||||||P-value for treatment-group effect (CL vs ECC)|ANCOVA|Treatment group F = 3.50 (Numerator df = 1, Denominator df varies, as multiple imputation was used).||"Analyses were ITT using PROC MI and PROC MI ANALYZE in conjunction with ANCOVA. We expected to reject the null hypothesis of no treatment group difference in 9 month PSWQ-A, controlling for baseline PSWQ-A.~Race/ethnicity and ERS-expectancies significantly differed between groups at baseline and were included as covariates.~A total of 134 participants allowed for 80% power to detect moderate group differences (d=.49) in primary and secondary outcomes given a 2-tailed type 1 error rate"||||0.07
72346094|NCT02391363|144215019|SUPERIORITY|||||||0.34||||||P-value for treatment-group effect (CL vs ECC)|ANCOVA|Treatment group F = 0.92. (Numerator df = 1, Denominator df varies, as multiple imputation was used).||"Analyses were ITT using PROC MI and PROC MI ANALYZE in conjunction with ANCOVA. We expected to reject the null hypothesis of no treatment group difference in 6 month GAD-7, controlling for baseline GAD-7.~Race/ethnicity and ERS-expectancies significantly differed between groups at baseline and were included as covariates.~A total of 134 participants allowed for 80% power to detect moderate group differences (d=.49) in primary and secondary outcomes given a 2-tailed type 1 error rate"||||0.34
72346095|NCT02391363|144215020|SUPERIORITY|||||||0.08||||||P-value for treatment-group effect (CL vs ECC)|ANCOVA|Treatment group F = 3.20 (Numerator df = 1, Denominator df varies, as multiple imputation was used).||"Analyses were ITT using PROC MI and PROC MI ANALYZE in conjunction with ANCOVA. We expected to reject the null hypothesis of no treatment group difference in 9 month GAD-7, controlling for baseline GAD-7.~Race/ethnicity and ERS-expectancies significantly differed between groups at baseline and were included as covariates.~A total of 134 participants allowed for 80% power to detect moderate group differences (d=.49) in primary and secondary outcomes given a 2-tailed type 1 error rate"||||0.08
72346096|NCT02391363|144215021|SUPERIORITY|||||||0.45||||||P-value for treatment-group effect (CL vs ECC)|ANCOVA|Treatment group F = 0.59 (Numerator df = 1, Denominator df varies, as multiple imputation was used).||"Analyses were ITT using PROC MI and PROC MI ANALYZE in conjunction with ANCOVA. We expected to reject the null hypothesis of no treatment group difference in 6 month GAI-SF, controlling for baseline GAI-SF.~Race/ethnicity and ERS-expectancies significantly differed between groups at baseline and were included as covariates.~A total of 134 participants allowed for 80% power to detect moderate group differences (d=.49) in primary and secondary outcomes given a 2-tailed type 1 error rate"||||0.45
72346097|NCT02391363|144215022|SUPERIORITY|||||||0.13||||||P-value for treatment-group effect (CL vs ECC)|ANCOVA|Treatment group F = 2.37 (Numerator df = 1, Denominator df varies, as multiple imputation was used).||"Analyses were ITT using PROC MI and PROC MI ANALYZE in conjunction with ANCOVA. We expected to reject the null hypothesis of no treatment group difference in 9 month GAI-SF, controlling for baseline GAI-SF.~Race/ethnicity and ERS-expectancies significantly differed between groups at baseline and were included as covariates.~A total of 134 participants allowed for 80% power to detect moderate group differences (d=.49) in primary and secondary outcomes given a 2-tailed type 1 error rate"||||0.13
72346098|NCT02391363|144215023|SUPERIORITY|||||||0.52||||||P-value for treatment-group effect (CL vs ECC)|ANCOVA|Treatment group F = 0.42 (Numerator df = 1, Denominator df varies, as multiple imputation was used).||"Analyses were ITT using PROC MI and PROC MI ANALYZE in conjunction with ANCOVA. We expected to reject the null hypothesis of no treatment group difference in 6 month PHQ-8, controlling for baseline PHQ-8.~Race/ethnicity and ERS-expectancies significantly differed between groups at baseline and were included as covariates.~A total of 134 participants allowed for 80% power to detect moderate group differences (d=.49) in primary and secondary outcomes given a 2-tailed type 1 error rate"||||0.52
72346099|NCT02391363|144215024|SUPERIORITY|||||||0.29||||||P-value for treatment-group effect (CL vs ECC)|ANCOVA|Treatment group F = 1.14 (Numerator df = 1, Denominator df varies, as multiple imputation was used).||"Analyses were ITT using PROC MI and PROC MI ANALYZE in conjunction with ANCOVA. We expected to reject the null hypothesis of no treatment group difference in 9 month PHQ-8, controlling for baseline PHQ-8.~Race/ethnicity and ERS-expectancies significantly differed between groups at baseline and were included as covariates.~A total of 134 participants allowed for 80% power to detect moderate group differences (d=.49) in primary and secondary outcomes given a 2-tailed type 1 error rate"||||0.29
72346100|NCT02391363|144215025|SUPERIORITY|||||||0.14||||||P-value for treatment-group effect (CL vs ECC)|ANCOVA|Treatment group F = 2.19 (Numerator df = 1, Denominator df varies, as multiple imputation was used).||"Analyses were ITT using PROC MI and PROC MI ANALYZE in conjunction with ANCOVA. We expected to reject the null hypothesis of no treatment group difference in 6 month GDS-SF, controlling for baseline GDS-SF.~Race/ethnicity and ERS-expectancies significantly differed between groups at baseline and were included as covariates.~A total of 134 participants allowed for 80% power to detect moderate group differences (d=.49) in primary and secondary outcomes given a 2-tailed type 1 error rate"||||0.14
72346101|NCT02391363|144215026|SUPERIORITY|||||||0.59||||||P-value for treatment-group effect (CL vs ECC)|ANCOVA|Treatment group F = 0.30 (Numerator df = 1, Denominator df varies, as multiple imputation was used).||"Analyses were ITT using PROC MI and PROC MI ANALYZE in conjunction with ANCOVA. We expected to reject the null hypothesis of no treatment group difference in 9 month GDS-SF, controlling for baseline GDS-SF.~Race/ethnicity and ERS-expectancies significantly differed between groups at baseline and were included as covariates.~A total of 134 participants allowed for 80% power to detect moderate group differences (d=.49) in primary and secondary outcomes given a 2-tailed type 1 error rate"||||0.59
72370162|NCT00838513|144250666|SUPERIORITY_OR_OTHER||Percent of TMA event-free responders|80.0|||||TWO_SIDED|95.0|56.0|94.0||||||"With a total of 20 patients enrolled between both protocols and, assuming that the true expected probability of TMA Event-Free for eculizumab-treated patients is 40%, then the study had 93.5% power to detect a statistically significant difference. Up to approximately 30 patients were to be enrolled.~All analyses were based on the pooled data from the two protocols: C08-003A (adult) and C08-003B (adolescent), a similar protocol, for patients \<18 years with aHUS."||94|56|
72370163|NCT00838513|144250667|SUPERIORITY_OR_OTHER||Percent of hematologic normalization|90.0|||||TWO_SIDED|95.0|68.0|99.0||||||All analyses were based on the pooled data from the two protocols: C08-003A (adult) and C08-003B (adolescent), a similar protocol, for patients \<18 years with aHUS.||99|68|
72370164|NCT00838513|144250668|SUPERIORITY_OR_OTHER||Percent of complete TMA response|25.0|||||TWO_SIDED|95.0|9.0|49.0||||||All analyses were based on the pooled data from the two protocols: C08-003A (adult) and C08-003B (adolescent), a similar protocol, for patients \<18 years with aHUS.||49|9|
72346102|NCT02391363|144215027|SUPERIORITY|||||||0.64||||||P-value for treatment-group effect (CL vs ECC)|ANCOVA|Treatment group F = 0.22 (Numerator df = 1, Denominator df varies, as multiple imputation was used).||"Analyses were ITT using PROC MI and PROC MI ANALYZE in conjunction with ANCOVA. We expected to reject the null hypothesis of no treatment group difference in 6 month ISI, controlling for baseline ISI.~Race/ethnicity and ERS-expectancies significantly differed between groups at baseline and were included as covariates.~A total of 134 participants allowed for 80% power to detect moderate group differences (d=.49) in primary and secondary outcomes given a 2-tailed type 1 error rate"||||0.64
72346103|NCT02391363|144215028|SUPERIORITY|||||||0.35||||||P-value for treatment-group effect (CL vs ECC)|ANCOVA|Treatment group F = 0.88 (Numerator df = 1, Denominator df varies, as multiple imputation was used).||"Analyses were ITT using PROC MI and PROC MI ANALYZE in conjunction with ANCOVA. We expected to reject the null hypothesis of no treatment group difference in 9 month ISI, controlling for baseline ISI.~Race/ethnicity and ERS-expectancies significantly differed between groups at baseline and were included as covariates.~A total of 134 participants allowed for 80% power to detect moderate group differences (d=.49) in primary and secondary outcomes given a 2-tailed type 1 error rate"||||0.35
72346104|NCT02391363|144215029|SUPERIORITY|||||||0.52||||||P-value for treatment-group effect (CL vs ECC)|ANCOVA|Treatment group F = 0.42 (Numerator df = 1, Denominator df varies, as multiple imputation was used).||"Analyses were ITT using PROC MI and PROC MI ANALYZE in conjunction with ANCOVA. We expected to reject the null hypothesis of no treatment group difference in 6 month LL-FDI, controlling for baseline LL-FDI.~Race/ethnicity and ERS-expectancies significantly differed between groups at baseline and were included as covariates.~A total of 134 participants allowed for 80% power to detect moderate group differences (d=.49) in primary and secondary outcomes given a 2-tailed type 1 error rate"||||0.52
72346105|NCT02391363|144215030|SUPERIORITY|||||||0.92||||||P-value for treatment-group effect (CL vs ECC)|ANCOVA|Treatment group F = .01(Numerator df = 1, Denominator df varies, as multiple imputation was used).||"Analyses were ITT using PROC MI and PROC MI ANALYZE in conjunction with ANCOVA. We expected to reject the null hypothesis of no treatment group difference in 9 month LL-FDI, controlling for baseline LL-FDI.~Race/ethnicity and ERS-expectancies significantly differed between groups at baseline and were included as covariates.~A total of 134 participants allowed for 80% power to detect moderate group differences (d=.49) in primary and secondary outcomes given a 2-tailed type 1 error rate"||||0.92
72346106|NCT02391363|144215031|SUPERIORITY|||||||0.59||||||P-value for treatment-group effect (CL vs ECC)|ANCOVA|Treatment group F = 0.29 (Numerator df = 1, Denominator df varies, as multiple imputation was used).||"Analyses were ITT using PROC MI and PROC MI ANALYZE in conjunction with ANCOVA. We expected to reject the null hypothesis of no treatment group difference in 6 month LL-FDI, controlling for baseline LL-FDI.~Race/ethnicity and ERS-expectancies significantly differed between groups at baseline and were included as covariates.~A total of 134 participants allowed for 80% power to detect moderate group differences (d=.49) in primary and secondary outcomes given a 2-tailed type 1 error rate"||||0.59
72346107|NCT02391363|144215032|SUPERIORITY|||||||0.89||||||P-value for treatment-group effect (CL vs ECC)|ANCOVA|Treatment group F = 0.20 (Numerator df = 1, Denominator df varies, as multiple imputation was used).||"Analyses were ITT using PROC MI and PROC MI ANALYZE in conjunction with ANCOVA. We expected to reject the null hypothesis of no treatment group difference in 9 month LL-FDI, controlling for baseline LL-FDI.~Race/ethnicity and ERS-expectancies significantly differed between groups at baseline and were included as covariates.~A total of 134 participants allowed for 80% power to detect moderate group differences (d=.49) in primary and secondary outcomes given a 2-tailed type 1 error rate"||||0.89
72346108|NCT02391363|144215033|SUPERIORITY|||||||0.64||||||P-value for treatment-group effect (CL vs ECC)|ANCOVA|Treatment group F= 0.23 (Numerator df = 1, Denominator df varies, as multiple imputation was used).||"Analyses were ITT using PROC MI and PROC MI ANALYZE in conjunction with ANCOVA. We expected to reject the null hypothesis of no treatment group difference in 6 month SF-12, controlling for baseline SF-12.~Race/ethnicity and ERS-expectancies significantly differed between groups at baseline and were included as covariates.~A total of 134 participants allowed for 80% power to detect moderate group differences (d=.49) in primary and secondary outcomes given a 2-tailed type 1 error rate"||||0.64
72346109|NCT02391363|144215034|SUPERIORITY|||||||0.94||||||P-value for treatment-group effect (CL vs ECC)|ANCOVA|Treatment group F = 0.00 (Numerator df = 1, Denominator df varies, as multiple imputation was used).||"Analyses were ITT using PROC MI and PROC MI ANALYZE in conjunction with ANCOVA. We expected to reject the null hypothesis of no treatment group difference in 9 month SF-12, controlling for baseline SF-12.~Race/ethnicity and ERS-expectancies significantly differed between groups at baseline and were included as covariates.~A total of 134 participants allowed for 80% power to detect moderate group differences (d=.49) in primary and secondary outcomes given a 2-tailed type 1 error rate"||||0.94
72346110|NCT02391363|144215035|SUPERIORITY|||||||0.98||||||P-value for treatment-group effect (CL vs ECC)|ANCOVA|Treatment group F = 0.00 (Numerator df = 1, Denominator df varies, as multiple imputation was used).||"Analyses were ITT using PROC MI and PROC MI ANALYZE in conjunction with ANCOVA. We expected to reject the null hypothesis of no treatment group difference in 6 month SF-12, controlling for baseline SF-12.~Race/ethnicity and ERS-expectancies significantly differed between groups at baseline and were included as covariates.~A total of 134 participants allowed for 80% power to detect moderate group differences (d=.49) in primary and secondary outcomes given a 2-tailed type 1 error rate"||||0.98
72346111|NCT02391363|144215036|SUPERIORITY|||||||0.88||||||P-value for treatment-group effect (CL vs ECC)|ANCOVA|Treatment group F= 0.02 (Numerator df = 1, Denominator df varies, as multiple imputation was used).||"Analyses were ITT using PROC MI and PROC MI ANALYZE in conjunction with ANCOVA. We expected to reject the null hypothesis of no treatment group difference in 9 month SF-12, controlling for baseline SF-12.~Race/ethnicity and ERS-expectancies significantly differed between groups at baseline and were included as covariates.~A total of 134 participants allowed for 80% power to detect moderate group differences (d=.49) in primary and secondary outcomes given a 2-tailed type 1 error rate"||||0.88
72370165|NCT00838513|144250669|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.29|||<|0.0001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||All analyses were based on the pooled data from the two protocols: C08-003A (adult) and C08-003B (adolescent), a similar protocol, for patients \<18 years with aHUS.||||<0.0001
72429020|NCT02404493|144368937|SUPERIORITY_OR_OTHER|||||||0.06||||||The significance level threshold level was 0.05.|One sample t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||0.060
72346112|NCT02391363|144215037|SUPERIORITY|||||||0.31||||||P-value for treatment-group effect (CL vs ECC)|ANCOVA|Treatment group F = 1.02 (Numerator df = 1, Denominator df varies, as multiple imputation was used).||"Analyses were ITT using PROC MI and PROC MI ANALYZE in conjunction with ANCOVA. We expected to reject the null hypothesis of no treatment group difference in 6 month PCL-5, controlling for baseline PCL-5.~Race/ethnicity and ERS-expectancies significantly differed between groups at baseline and were included as covariates.~A total of 134 participants allowed for 80% power to detect moderate group differences (d=.49) in primary and secondary outcomes given a 2-tailed type 1 error rate"||||0.31
72346113|NCT02391363|144215038|SUPERIORITY|||||||0.96||||||P-value for treatment-group effect (CL vs ECC)|ANCOVA|Treatment group F = 0.00 (Numerator df = 1, Denominator df varies, as multiple imputation was used).||"Analyses were ITT using PROC MI and PROC MI ANALYZE in conjunction with ANCOVA. We expected to reject the null hypothesis of no treatment group difference in 9 month PCL-5, controlling for baseline PCL-5.~Race/ethnicity and ERS-expectancies significantly differed between groups at baseline and were included as covariates.~A total of 134 participants allowed for 80% power to detect moderate group differences (d=.49) in primary and secondary outcomes given a 2-tailed type 1 error rate"||||0.96
72346114|NCT02391363|144215039|SUPERIORITY|"We expected to reject the null hypothesis of no treatment group difference in 6 month health service use, controlling for baseline health service use.~Race/ethnicity and ERS-expectancies significantly differed between groups at baseline and were included as covariates.~A total of 134 participants allowed for 80% power to detect moderate group differences (d=.49) in primary and secondary outcomes given a 2-tailed type 1 error rate"||||||0.52||||||Parameter estimate for treatment group = 0.40 (SE = 0.63). Controlled for baseline health service use, ERS-expectancies and race/ethnicity|Regression, Logistic|ITT analyses with PROC MI AND MI ANALYZE in conjunction with multiple logistic regression.||||||0.52
72346115|NCT02391363|144215040|SUPERIORITY|||||||0.04||||||Parameter estimate for treatment group = 1.79 (SE = 0.85). Controlled for baseline health service use, ERS-expectancies and race/ethnicity|Regression, Logistic|ITT analyses with PROC MI AND MI ANALYZE in conjunction with multiple logistic regression.||"We expected to reject the null hypothesis of no treatment group difference in 9 month health service use, controlling for baseline health service use.~Race/ethnicity and ERS-expectancies significantly differed between groups at baseline and were included as covariates.~A total of 134 participants allowed for 80% power to detect moderate group differences (d=.49) in primary and secondary outcomes given a 2-tailed type 1 error rate"||||0.04
72346116|NCT02391363|144215041|SUPERIORITY|||||||0.04||||||Parameter estimate for treatment group = 1.56 (SE = 0.74). Controlled for baseline health service use, ERS-expectancies and race/ethnicity|Regression, Logistic|ITT analyses with PROC MI AND MI ANALYZE in conjunction with multiple logistic regression.||"We expected to reject the null hypothesis of no treatment group difference in 6 month hospital admissions, controlling for baseline hospital admissions.~Race/ethnicity and ERS-expectancies significantly differed between groups at baseline and were included as covariates.~A total of 134 participants allowed for 80% power to detect moderate group differences (d=.49) in primary and secondary outcomes given a 2-tailed type 1 error rate"||||0.04
72346117|NCT02391363|144215042|SUPERIORITY|||||||0.001||||||Parameter estimate for treatment group = 2.96 (SE = 0.91). Controlled for baseline health service use, ERS-expectancies and race/ethnicity|Regression, Logistic|ITT analyses with PROC MI AND MI ANALYZE in conjunction with multiple logistic regression.||"We expected to reject the null hypothesis of no treatment group difference in 9 month hospital admissions, controlling for baseline hospital admissions.~Race/ethnicity and ERS-expectancies significantly differed between groups at baseline and were included as covariates.~A total of 134 participants allowed for 80% power to detect moderate group differences (d=.49) in primary and secondary outcomes given a 2-tailed type 1 error rate"||||0.001
72346118|NCT02391363|144215043|SUPERIORITY|||||||0.42||||||Parameter estimate for treatment group = 0.42 (SE = 0.51). Controlled for baseline health service use, ERS-expectancies and race/ethnicity|Regression, Logistic|ITT analyses with PROC MI AND MI ANALYZE in conjunction with multiple logistic regression.||"We expected to reject the null hypothesis of no treatment group difference in 6 month social service use, controlling for baseline social service use.~Race/ethnicity and ERS-expectancies significantly differed between groups at baseline and were included as covariates.~A total of 134 participants allowed for 80% power to detect moderate group differences (d=.49) in primary and secondary outcomes given a 2-tailed type 1 error rate"||||0.42
72346119|NCT02391363|144215044|SUPERIORITY|||||||0.85||||||Parameter estimate for treatment group = 0.09 (SE = 0.47). Controlled for baseline health service use, ERS-expectancies and race/ethnicity|Regression, Logistic|ITT analyses with PROC MI AND MI ANALYZE in conjunction with multiple logistic regression.||"We expected to reject the null hypothesis of no treatment group difference in 9 month social service use, controlling for baseline social service use.~Race/ethnicity and ERS-expectancies significantly differed between groups at baseline and were included as covariates.~A total of 134 participants allowed for 80% power to detect moderate group differences (d=.49) in primary and secondary outcomes given a 2-tailed type 1 error rate"||||0.85
72346120|NCT02391363|144215045|SUPERIORITY|||||||0.55||||||Parameter estimate for treatment group = -0.28 (SE = 0.46). Controlled for baseline health service use, ERS-expectancies and race/ethnicity|Regression, Logistic|ITT analyses with PROC MI AND MI ANALYZE in conjunction with multiple logistic regression.||"We expected to reject the null hypothesis of no treatment group difference in 6 month psychological service use, controlling for baseline psychological service use.~Race/ethnicity and ERS-expectancies significantly differed between groups at baseline and were included as covariates.~A total of 134 participants allowed for 80% power to detect moderate group differences (d=.49) in primary and secondary outcomes given a 2-tailed type 1 error rate"||||0.55
72346121|NCT02391363|144215046|SUPERIORITY|||||||0.54||||||Parameter estimate for treatment group = -0.29 (SE = 0.47). Controlled for baseline health service use, ERS-expectancies and race/ethnicity|Regression, Logistic|ITT analyses with PROC MI AND MI ANALYZE in conjunction with multiple logistic regression.||"We expected to reject the null hypothesis of no treatment group difference in 9 month psychological service use, controlling for baseline psychological service use.~Race/ethnicity and ERS-expectancies significantly differed between groups at baseline and were included as covariates.~A total of 134 participants allowed for 80% power to detect moderate group differences (d=.49) in primary and secondary outcomes given a 2-tailed type 1 error rate"||||0.54
72346122|NCT02510001|144215053|OTHER||||||||||||||||||"The primary dose escalation analysis was to find the MTD, which was defined as the dose of PF-02341066 in combination with PD-0325901 at which no more than one out of six patients experience a DLT (dose limiting toxicity). The DLT was based on observed toxicity in cycle 1, and was defined as an almost certainly or probably drug-related adverse event to PF-02341066 and/or PD-0325901.~The MTD for the PD 0325901/PF-02341066 combination was 8mg BD(days1-21) and 200mg BD continuously in a 28 day cycle (Dose Level 4)."|||
72346123|NCT02510001|144215055|OTHER|||||||||||||||||The primary dose escalation analysis was to find the MTD, which was defined as the dose of PF-02341066 in combination with Binimetinib at which no more than one out of six patients experience a DLT (dose limiting toxicity). The DLT was based on observed toxicity in cycle 1, and was defined as an almost certainly or probably drug-related adverse event to PF-02341066 and/or Binimetinib.|"Binimetinib 30mg BD on days 1 - 21 every 28 days with Crizotinib 250 mg OD continuously is the MTD, the recommended dose and schedule for further evaluation in our and other trials.~This was as only one DLT was experienced in 6 evaluable patients at this final dose escalation level."|||
72346124|NCT02967510|144215085|SUPERIORITY||Median Difference (Final Values)|0.0|||=|0.304|TWO_SIDED|95.0|-1.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|-1|=0.304
72346125|NCT02967510|144215085|SUPERIORITY||Mean Difference (Final Values)|0.0|||=|0.109|TWO_SIDED|95.0|-1.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|-1|=0.109
72346126|NCT02967510|144215085|SUPERIORITY||Median Difference (Final Values)|0.0|||=|0.119|TWO_SIDED|95.0|0.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|0|=0.119
72346127|NCT02967510|144215086|SUPERIORITY||LS Mean Difference|-0.74|||<|0.001|TWO_SIDED|95.0|-1.031|-0.444|||ANCOVA|||||-0.444|-1.031|<0.001
72346128|NCT02967510|144215086|SUPERIORITY||LS Mean Difference|-0.75|||<|0.001|TWO_SIDED|95.0|-1.051|-0.458|||ANCOVA|||||-0.458|-1.051|<0.001
72346129|NCT02967510|144215086|SUPERIORITY||LS Mean Difference|-0.66|||<|0.001|TWO_SIDED|95.0|-0.951|-0.369|||ANCOVA|||||-0.369|-0.951|<0.001
72346130|NCT02967510|144215087|SUPERIORITY||LS Mean Difference|0.21|||<|0.001|TWO_SIDED|95.0|0.147|0.278|||ANCOVA|||||0.278|0.147|<0.001
72346131|NCT02967510|144215087|SUPERIORITY||LS Mean Difference|0.15|||<|0.001|TWO_SIDED|95.0|0.078|0.213|||ANCOVA|||||0.213|0.078|<0.001
72346132|NCT02967510|144215087|SUPERIORITY||LS Mean Difference|0.16|||<|0.001|TWO_SIDED|95.0|0.097|0.226|||ANCOVA|||||0.226|0.097|<0.001
72346133|NCT02967510|144215088|SUPERIORITY||LS Mean Difference|-0.5|||<|0.001|TWO_SIDED|95.0|-0.603|-0.4|||ANCOVA|||||-0.4|-0.603|<0.001
72346134|NCT02967510|144215088|SUPERIORITY||LS Mean Difference|-0.47|||<|0.001|TWO_SIDED|95.0|-0.572|-0.365|||ANCOVA|||||-0.365|-0.572|<0.001
72346135|NCT02967510|144215088|SUPERIORITY||LS Mean Difference|-0.43|||<|0.001|TWO_SIDED|95.0|-0.531|-0.331|||ANCOVA|||||-0.331|-0.531|<0.001
72346136|NCT02967510|144215089|SUPERIORITY||Mean Difference (Final Values)|0.0|||=|0.47|TWO_SIDED|95.0|-1.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|-1|=0.47
72346137|NCT02967510|144215089|SUPERIORITY||Median Difference (Final Values)|0.0|||=|0.448|TWO_SIDED|95.0|-1.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|0|-1|=0.448
72346138|NCT02967510|144215089|SUPERIORITY||Median Difference (Final Values)|0.0|||=|0.451|TWO_SIDED|95.0|-1.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|-1|=0.451
72346139|NCT02967510|144215090|SUPERIORITY||Median Difference (Final Values)|0.0|||=|0.329|TWO_SIDED|95.0|0.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|0|=0.329
72346140|NCT02967510|144215090|SUPERIORITY||Median Difference (Final Values)|0.0|||=|0.348|TWO_SIDED|95.0|0.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|0|=0.348
72429021|NCT02404493|144368937|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|134.9|STANDARD_ERROR_OF_MEAN|79.567||0.107|TWO_SIDED|95.0|-32.266|302.063||The significance level threshold level was 0.05.|ANCOVA|Change from baseline as response, baseline score as covariate and treatment as factor.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||302.063|-32.266|0.107
72346141|NCT02967510|144215090|SUPERIORITY||Median Difference (Final Values)|0.0|||=|0.266|TWO_SIDED|95.0|0.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|0|=0.266
72346142|NCT02967510|144215091|SUPERIORITY||Median Difference (Final Values)|0.0|||=|0.122|TWO_SIDED|95.0|0.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|0|=0.122
72346143|NCT02967510|144215091|SUPERIORITY||Median Difference (Final Values)|0.0|||=|0.188|TWO_SIDED|95.0|0.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|0|=0.188
72346144|NCT02967510|144215091|SUPERIORITY||Median Difference (Final Values)|0.0|||=|0.222|TWO_SIDED|95.0|0.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|0|=0.222
72346145|NCT02967510|144215092|SUPERIORITY||Median Difference (Final Values)|0.0|||=|0.393|TWO_SIDED|95.0|0.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|0|=0.393
72346146|NCT02967510|144215092|SUPERIORITY||Median Difference (Final Values)|0.0|||=|0.221|TWO_SIDED|95.0|0.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|0|=0.221
72346147|NCT02967510|144215092|SUPERIORITY||Median Difference (Final Values)|0.0|||=|0.432|TWO_SIDED|95.0|0.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|0|=0.432
72346148|NCT02967510|144215093|SUPERIORITY||LS Mean Difference|0.24|||=|0.65|TWO_SIDED|95.0|-1.0|1.487|||ANCOVA|||||1.487|-1|=0.65
72346149|NCT02967510|144215093|SUPERIORITY||LS Mean Difference|-0.24|||=|0.361|TWO_SIDED|95.0|-1.568|1.09|||ANCOVA|||||1.09|-1.568|=0.361
72346150|NCT02967510|144215093|SUPERIORITY||LS Mean Difference|0.03|||=|0.522|TWO_SIDED|95.0|-1.188|1.257|||ANCOVA|||||1.257|-1.188|=0.522
72346151|NCT02967510|144215094|SUPERIORITY||LS Mean Difference|-0.56|||=|0.043|TWO_SIDED|95.0|-1.204|0.079|||ANCOVA|||||0.079|-1.204|=0.043
72346152|NCT02967510|144215094|SUPERIORITY||LS Mean Difference|-0.51|||=|0.061|TWO_SIDED|95.0|-1.158|0.137|||ANCOVA|||||0.137|-1.158|=0.061
72346153|NCT02967510|144215094|SUPERIORITY||LS Mean Difference|-0.48|||=|0.071|TWO_SIDED|95.0|-1.111|0.16|||ANCOVA|||||0.16|-1.111|=0.071
72346154|NCT02967510|144215095|SUPERIORITY||Median Difference (Final Values)|0.0|||=|0.012|TWO_SIDED|95.0|-1.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|-1|=0.012
72346155|NCT02967510|144215095|SUPERIORITY||Median Difference (Final Values)|0.0|||=|0.007|TWO_SIDED|95.0|-1.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|-1|=0.007
72346156|NCT02967510|144215095|SUPERIORITY||Median Difference (Final Values)|0.0|||<|0.001|TWO_SIDED|95.0|-1.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|-1|<0.001
72346157|NCT02967510|144215096|SUPERIORITY||Median Difference (Final Values)|0.0|||=|0.438|TWO_SIDED|95.0|0.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|0|=0.438
72346158|NCT02967510|144215096|SUPERIORITY||Median Difference (Final Values)|0.0|||=|0.388|TWO_SIDED|95.0|0.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|0|=0.388
72429022|NCT02404493|144368938|SUPERIORITY_OR_OTHER|||||||0.692||||||The significance level threshold level was 0.05.|One sample t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||0.692
72429023|NCT02404493|144368938|SUPERIORITY_OR_OTHER|||||||0.541||||||The significance level threshold level was 0.05.|One sample t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||0.541
72429024|NCT02404493|144368938|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.13|STANDARD_ERROR_OF_MEAN|0.18||0.492|TWO_SIDED|95.0|-0.25|0.502||The significance level threshold level was 0.05.|ANCOVA|Change from baseline as response, baseline score as covariate and treatment as factor.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.502|-0.250|0.492
72346159|NCT02967510|144215096|SUPERIORITY||Median Difference (Final Values)|0.0|||=|0.259|TWO_SIDED|95.0|0.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|0|=0.259
72346160|NCT02967510|144215097|SUPERIORITY||Median Difference (Final Values)|0.0|||=|0.022|TWO_SIDED|95.0|-1.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|-1|=0.022
72346161|NCT02967510|144215097|SUPERIORITY||Median Difference (Final Values)|0.0|||=|0.02|TWO_SIDED|95.0|-1.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|-1|=0.02
72346162|NCT02967510|144215097|SUPERIORITY||Median Difference (Final Values)|0.0|||=|0.003|TWO_SIDED|95.0|-1.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|-1|=0.003
72346163|NCT02967510|144215098|SUPERIORITY||Median Difference (Final Values)|0.0|||=|0.002|TWO_SIDED|95.0|-1.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|-1|=0.002
72346164|NCT02967510|144215098|SUPERIORITY||Median Difference (Final Values)|0.0|||=|0.331|TWO_SIDED|95.0|0.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|0|=0.331
72346165|NCT02967510|144215098|SUPERIORITY||Median Difference (Final Values)|0.0|||=|0.043|TWO_SIDED|95.0|0.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|0|=0.043
72346166|NCT02967510|144215099|SUPERIORITY||Median Difference (Final Values)|-1.0|||=|0.022|TWO_SIDED|95.0|-1.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|-1|=0.022
72346167|NCT02967510|144215099|SUPERIORITY||Median Difference (Final Values)|-1.0|||=|0.032|TWO_SIDED|95.0|-1.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|-1|=0.032
72346168|NCT02967510|144215099|SUPERIORITY||Median Difference (Final Values)|-1.0|||=|0.001|TWO_SIDED|95.0|-1.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|-1|=0.001
72346169|NCT02967510|144215100|SUPERIORITY||Median Difference (Final Values)|0.0|||=|0.176|TWO_SIDED|95.0|0.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|0|=0.176
72346170|NCT02967510|144215100|SUPERIORITY||Median Difference (Final Values)|0.0|||=|0.358|TWO_SIDED|95.0|0.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|0|=0.358
72346171|NCT02967510|144215100|SUPERIORITY||Median Difference (Final Values)|0.0|||=|0.21|TWO_SIDED|95.0|0.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|0|=0.21
72346172|NCT02967510|144215101|SUPERIORITY||Median Difference (Final Values)|0.0|||=|0.106|TWO_SIDED|95.0|0.0|1.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||1|0|=0.106
72346173|NCT02967510|144215101|SUPERIORITY||Median Difference (Final Values)|0.0|||=|0.229|TWO_SIDED|95.0|0.0|1.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||1|0|=0.229
72346174|NCT02967510|144215101|SUPERIORITY||Median Difference (Final Values)|0.0|||=|0.345|TWO_SIDED|95.0|-1.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|-1|=0.345
72346175|NCT02967510|144215102|SUPERIORITY||Median Difference (Final Values)|0.0|||=|0.026|TWO_SIDED|95.0|0.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|0|=0.026
72346176|NCT02967510|144215102|SUPERIORITY||Median Difference (Final Values)|0.0|||=|0.424|TWO_SIDED|95.0|0.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|0|=0.424
72346177|NCT02967510|144215102|SUPERIORITY||Median Difference (Final Values)|0.0|||=|0.414|TWO_SIDED|95.0|0.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|0|=0.414
72346178|NCT02967510|144215103|SUPERIORITY||Median Difference (Final Values)|0.0|||=|0.36|TWO_SIDED|95.0|0.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|0|=0.36
72346179|NCT02967510|144215103|SUPERIORITY||Median Difference (Final Values)|0.0|||=|0.12|TWO_SIDED|95.0|0.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|0|=0.12
72346180|NCT02967510|144215103|SUPERIORITY||Median Difference (Final Values)|0.0|||=|0.266|TWO_SIDED|95.0|0.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|0|=0.266
72346181|NCT02967510|144215104|SUPERIORITY||Median Difference (Final Values)|0.0|||=|0.47|TWO_SIDED|95.0|0.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|0|=0.47
72346182|NCT02967510|144215104|SUPERIORITY||Median Difference (Final Values)|0.0|||=|0.137|TWO_SIDED|95.0|0.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|0|=0.137
72346183|NCT02967510|144215104|SUPERIORITY||Median Difference (Final Values)|0.0|||=|0.133|TWO_SIDED|95.0|0.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|0|=0.133
72346184|NCT02967510|144215105|SUPERIORITY||LS Mean Difference|0.74|||=|0.85|TWO_SIDED|95.0|-0.669|2.153|||ANCOVA|||||2.153|-0.669|=0.85
72346185|NCT02967510|144215105|SUPERIORITY||LS Mean Difference|0.87|||=|0.877|TWO_SIDED|95.0|-0.611|2.361|||ANCOVA|||||2.361|-0.611|=0.877
72346186|NCT02967510|144215105|SUPERIORITY||LS Mean Difference|-0.64|||=|0.178|TWO_SIDED|95.0|-2.009|0.728|||ANCOVA|||||0.728|-2.009|=0.178
72346187|NCT02967510|144215106|SUPERIORITY||LS Mean Difference|-0.16|||=|0.323|TWO_SIDED|95.0|-0.854|0.531|||ANCOVA|||||0.531|-0.854|=0.323
72346188|NCT02967510|144215106|SUPERIORITY||LS Mean Difference|-0.22|||=|0.272|TWO_SIDED|95.0|-0.917|0.484|||ANCOVA|||||0.484|-0.917|=0.272
72346189|NCT02967510|144215106|SUPERIORITY||LS Mean Difference|-0.6|||=|0.043|TWO_SIDED|95.0|-1.29|0.084|||ANCOVA|||||0.084|-1.29|=0.043
72346190|NCT02967510|144215107|SUPERIORITY||Median Difference (Final Values)|0.0|||=|0.009|TWO_SIDED|95.0|-1.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|-1|=0.009
72346191|NCT02967510|144215107|SUPERIORITY||Median Difference (Final Values)|0.0|||=|0.025|TWO_SIDED|95.0|-1.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|-1|=0.025
72346192|NCT02967510|144215107|SUPERIORITY||Median Difference (Final Values)|0.0|||<|0.001|TWO_SIDED|95.0|-1.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|-1|<0.001
72429025|NCT02404493|144368939|SUPERIORITY_OR_OTHER|||||||0.017||||||The significance level threshold level was 0.05.|One sample t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||0.017
72346193|NCT02967510|144215108|SUPERIORITY||Median Difference (Final Values)|0.0|||=|0.04|TWO_SIDED|95.0|-1.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|-1|=0.04
72346194|NCT02967510|144215108|SUPERIORITY||Median Difference (Final Values)|0.0|||=|0.259|TWO_SIDED|95.0|0.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|0|=0.259
72346195|NCT02967510|144215108|SUPERIORITY||Median Difference (Final Values)|0.0|||=|0.104|TWO_SIDED|95.0|0.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|0|=0.104
72346196|NCT02967510|144215109|SUPERIORITY||Median Difference (Final Values)|-1.0|||<|0.001|TWO_SIDED|95.0|-1.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|-1|<0.001
72346197|NCT02967510|144215109|SUPERIORITY||Median Difference (Final Values)|-1.0|||<|0.001|TWO_SIDED|95.0|-1.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|-1|<0.001
72346198|NCT02967510|144215109|SUPERIORITY||Median Difference (Final Values)|0.0|||<|0.001|TWO_SIDED|95.0|-1.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|-1|<0.001
72346199|NCT02967510|144215110|SUPERIORITY||Median Difference (Final Values)|0.0|||<|0.001|TWO_SIDED|95.0|-1.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|-1|<0.001
72346200|NCT02967510|144215110|SUPERIORITY||Median Difference (Final Values)|0.0|||=|0.054|TWO_SIDED|95.0|0.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|0|=0.054
72346201|NCT02967510|144215110|SUPERIORITY||Median Difference (Final Values)|0.0|||<|0.001|TWO_SIDED|95.0|0.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|0|<0.001
72346202|NCT02967510|144215111|SUPERIORITY||Median Difference (Final Values)|0.0|||=|0.008|TWO_SIDED|95.0|-1.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|-1|=0.008
72346203|NCT02967510|144215111|SUPERIORITY||Median Difference (Final Values)|-1.0|||=|0.01|TWO_SIDED|95.0|-1.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|-1|=0.01
72346204|NCT02967510|144215111|SUPERIORITY||Median Difference (Final Values)|0.0|||=|0.001|TWO_SIDED|95.0|-1.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|-1|=0.001
72346205|NCT02967510|144215112|SUPERIORITY||LS Mean Difference|-0.81|||<|0.001|TWO_SIDED|95.0|-1.071|-0.548|||ANCOVA|||||-0.548|-1.071|<0.001
72429026|NCT02404493|144368939|SUPERIORITY_OR_OTHER|||||||0.223||||||The significance level threshold level was 0.05.|One sample t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||0.223
72346206|NCT02967510|144215112|SUPERIORITY||LS Mean Difference|-0.75|||<|0.001|TWO_SIDED|95.0|-1.013|-0.484|||ANCOVA|||||-0.484|-1.013|<0.001
72346207|NCT02967510|144215112|SUPERIORITY||LS Mean Difference|-0.66|||<|0.001|TWO_SIDED|95.0|-0.916|-0.397|||ANCOVA|||||-0.397|-0.916|<0.001
72346208|NCT02967510|144215113|SUPERIORITY||LS Mean Difference|0.44|||<|0.001|TWO_SIDED|95.0|0.337|0.535|||ANCOVA|||||0.535|0.337|<0.001
72346209|NCT02967510|144215113|SUPERIORITY||LS Mean Difference|0.39|||<|0.001|TWO_SIDED|95.0|0.291|0.494|||ANCOVA|||||0.494|0.291|<0.001
72346210|NCT02967510|144215113|SUPERIORITY||LS Mean Difference|0.34|||<|0.001|TWO_SIDED|95.0|0.245|0.439|||ANCOVA|||||0.439|0.245|<0.001
72346211|NCT02967510|144215114|SUPERIORITY||LS Mean Difference|-0.47|||<|0.001|TWO_SIDED|95.0|-0.575|-0.371|||ANCOVA|||||-0.371|-0.575|<0.001
72346212|NCT02967510|144215114|SUPERIORITY||LS Mean Difference|-0.49|||<|0.001|TWO_SIDED|95.0|-0.592|-0.383|||ANCOVA|||||-0.383|-0.592|<0.001
72346213|NCT02967510|144215114|SUPERIORITY||LS Mean Difference|-0.4|||<|0.001|TWO_SIDED|95.0|-0.5|-0.3|||ANCOVA|||||-0.3|-0.5|<0.001
72346214|NCT00856544|144215147|SUPERIORITY_OR_OTHER||Percent difference|27.04|||<|0.0001|TWO_SIDED|95.0|17.94|36.13||A step-down procedure was used to control for multiple comparisons. In order for the comparison to 5 mg to be statistically significant, the comparison to 10 mg had to be statistically significant.|Normal approximation|||Normal approximation to the binomial distribution was used to test the superiority of each dose of CP-690,550 10 mg to placebo and 2-sided 95% confidence interval (CI) was evaluated for the difference in percentages.||36.13|17.94|<0.0001
72346215|NCT00856544|144215147|SUPERIORITY_OR_OTHER||Percent Difference|21.52|||<|0.0001|TWO_SIDED|95.0|12.39|30.65||A step-down procedure was used to control for multiple comparisons. In order for the comparison to 5 mg to be statistically significant, the comparison to 10 mg had to be statistically significant.|Normal Approximation|||Normal approximation to the binomial distribution was used to test the superiority of each dose of CP-690,550 5 mg to placebo and 2-sided 95% CI was evaluated for the difference in percentages.||30.65|12.39|<0.0001
72346216|NCT00856544|144215148|SUPERIORITY_OR_OTHER||LS mean difference|-0.35|STANDARD_ERROR_OF_MEAN|0.05|<|0.0001|TWO_SIDED|95.0|-0.44|-0.26||A step-down procedure was used to control for multiple comparisons. For the comparison of 10 mg to placebo to be statistically significant, the comparison of 10 mg to placebo in ACR20 had to be significant.|Mixed Models Analysis|||Least squares mean difference (LS Mean Difference) and corresponding 95% CI was calculated using a mixed effect repeated measure model with treatments, visits and treatment-by-visit interaction as fixed effects and participants as a random effect.||-0.26|-0.44|<0.0001
72346217|NCT00856544|144215148|SUPERIORITY_OR_OTHER||LS mean difference|-0.26|STANDARD_ERROR_OF_MEAN|0.05|<|0.0001|TWO_SIDED|95.0|-0.35|-0.16||A step-down procedure was used to control for multiple comparisons. For comparison of 5 mg to placebo to be statistically significant, comparison of 10 mg to placebo and comparison of 5 mg to placebo in ACR20 had to be statistically significant.|Mixed Models Analysis|||LS Mean Difference and corresponding 95% CI was calculated using a mixed effect repeated measure model with treatments, visits and treatment-by-visit interaction as fixed effects and participants as a random effect.||-0.16|-0.35|<0.0001
72346218|NCT00856544|144215149|SUPERIORITY_OR_OTHER||Percent difference|10.63|||<|0.0001|TWO_SIDED|95.0|5.8|15.45||A step-down procedure was used to control for multiple comparisons. For the comparison of 10 mg to placebo to be statistically significant, the comparison of 10 mg to placebo in HAQ-DI had to be significant.|Normal Approximation|||Normal approximation to the binomial distribution was used to test the superiority of each dose of CP-690,550 10 mg to placebo and 2-sided 95% CI was evaluated for the difference in percentages.||15.45|5.80|<0.0001
72346219|NCT00856544|144215149|SUPERIORITY_OR_OTHER||Percent difference|6.42||||0.0038|TWO_SIDED|95.0|2.07|10.77||A step-down procedure was used to control for multiple comparisons. For comparison of 5 mg to placebo to be statistically significant, comparison of 10 mg to placebo and comparison of 5 mg to placebo in HAQ-DI had to be statistically significant.|Normal Approximation|||Normal approximation to the binomial distribution was used to test the superiority of each dose of CP-690,550 5 mg to placebo and 2-sided 95% CI was evaluated for the difference in percentages.||10.77|2.07|0.0038
72346220|NCT00787189|144215194|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0005||95.0|||||Fisher Exact|||||||<0.0005
72346221|NCT05274269|144215222|SUPERIORITY||LS Mean difference|9.2|||<|0.0001|TWO_SIDED|95.0|7.2|11.3|||Mixed Models for Repeated Measures|||||11.3|7.2|< 0.0001
72346222|NCT05274269|144215223|SUPERIORITY||LS Mean difference|-28.3|||<|0.0001|TWO_SIDED|95.0|-32.1|-24.5|||Mixed Models for Repeated Measures|||||-24.5|-32.1|< 0.0001
72346223|NCT05274269|144215224|SUPERIORITY||LS Mean difference|19.5|||<|0.0001|TWO_SIDED|95.0|15.5|23.5|||Mixed Models for Repeated Measures|||||23.5|15.5|< 0.0001
72346224|NCT05274269|144215225|SUPERIORITY||LS Mean difference|0.47|||<|0.0001|TWO_SIDED|95.0|0.24|0.69|||Mixed Models for Repeated Measures|||||0.69|0.24|< 0.0001
72346225|NCT05274269|144215226|SUPERIORITY||LS Mean difference|1.3|||<|0.0001|TWO_SIDED|95.0|0.6|1.9|||Mixed Models for Repeated Measures|||||1.9|0.6|< 0.0001
72346226|NCT00773747|144215285|SUPERIORITY||Cox Proportional Hazard|0.774|||=|0.01|TWO_SIDED|95.0|0.636|0.941|||Regression, Cox|||Cox model stratified by myeloma stage at enrollment, history of a bone marrow transplant, and number of prior treatment regimens, with a single treatment covariate.||0.941|0.636|= 0.0100
72346227|NCT00773747|144215287|SUPERIORITY||Cox Proportional Hazard|0.858||||0.3496|TWO_SIDED|95.0|0.622|1.184|||Regression, Cox|||Cox model stratified by myeloma stage at enrollment, history of a bone marrow transplant, and number of prior treatment regimens, with a single treatment covariate.||1.184|0.622|0.3496
72346228|NCT04260347|144215290|OTHER||Risk Ratio (RR)|1.064||||1|TWO_SIDED|95.0|0.345|1.784|||Chi-squared||Actilyse® (alteplase) pre-approval participants were used as reference group.|||1.784|0.345|1.000
72429027|NCT02404493|144368939|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.15|STANDARD_ERROR_OF_MEAN|0.231||0.518|TWO_SIDED|95.0|-0.635|0.331||The significance level threshold level was 0.05.|ANCOVA|Change from baseline as response, baseline score as covariate and treatment as factor.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.331|-0.635|0.518
72346229|NCT04260347|144215291|OTHER||Risk Ratio (RR)|0.889||||0.254|TWO_SIDED|95.0|0.699|1.08|||Chi-squared||Actilyse® (alteplase) pre-approval participants were used as reference group.|||1.08|0.699|0.254
72346230|NCT04260347|144215292|OTHER||Risk Ratio (RR)|1.089||||0.28|TWO_SIDED|95.0|0.942|1.237|||Chi-squared||Actilyse® (alteplase) pre-approval participants were used as reference group.|||1.237|0.942|0.280
72346231|NCT04260347|144215293|OTHER||Standardized Mean Difference (SMD)|0.016||||0.916|TWO_SIDED|95.0|-0.096|0.128|||Wilcoxon (Mann-Whitney)||SMD = Difference in the mean between groups / Standard deviation Actilyse® (alteplase) pre-approval participants were used as reference group.|||0.128|-0.096|0.916
72346232|NCT04260347|144215294|OTHER||Risk Ratio (RR)|1.066||||0.561|TWO_SIDED|95.0|0.872|1.261|||Chi-squared||Actilyse® (alteplase) pre-approval participants were used as reference group.|||1.261|0.872|0.561
72346233|NCT04260347|144215295|OTHER||Risk Ratio (RR)|1.231||||0.522|TWO_SIDED|95.0|0.707|1.756|||Chi-squared||Actilyse® (alteplase) pre-approval participants were used as reference group.|||1.756|0.707|0.522
72346234|NCT04260347|144215296|OTHER||Standardized Mean Difference (SMD)|-0.021||||0.81|TWO_SIDED|95.0|-0.133|0.091|||Wilcoxon (Mann-Whitney)||SMD = Difference in mean between groups / Standard deviation Actilyse® (alteplase) pre-approval participants were used as reference group.|||0.091|-0.133|0.810
72346235|NCT04260347|144215297|OTHER||Standardized Mean Difference (SMD)|-0.085||||0.179|TWO_SIDED|95.0|-0.199|0.03|||Wilcoxon (Mann-Whitney)||SMD = Difference in mean between groups / Standard deviation Actilyse® (alteplase) pre-approval participants were used as reference group.|||0.03|-0.199|0.179
72346236|NCT04260347|144215298|OTHER||Standardized Mean Difference (SMD)|0.042||||0.275|TWO_SIDED|95.0|-0.072|0.156|||Wilcoxon (Mann-Whitney)||SMD = Difference in mean between groups / Standard deviation Actilyse® (alteplase) pre-approval participants were used as reference group.|||0.156|-0.072|0.275
72346237|NCT04164732|144215327|SUPERIORITY||Median Difference (Net)|0.61||||0.5506|TWO_SIDED|80.0|-0.71|1.94|||longitudinal mixed effects (MMRM) model|||||1.94|-0.71|0.5506
72346238|NCT04302545|144215328|OTHER|Other Primary outcomes were the extent of injury, operative time, blood loss and proportion of subjects receiving a blood transfusion. Postoperatively, subjects were assessed for secondary outcomes of UTI, micturition problems, and fistula formation during the hospital stay and for the next 3 months. Postoperative micturition problems were feeling of incomplete evacuation, frequency, urgency, urethral and extra-urethral incontinence.|Odds Ratio (OR)|-0.178|||<|0.0001|TWO_SIDED|95.0|-0.261|-0.094||The threshold for statistical significance was \<.05.|Regression, Linear|||"Null Hypothesis: During the cesarean section of women with adhesions of the previous cesarean section that obscure the bladder, the bladder injury rate is not significantly decreased in cystoinflation group compared to the control.~In this study, the bladder injury rate was seven times lesser in cystoinflation group compared to the control, thereby strongly supporting our hypothesis. The power of the study for bladder injury was 0.988, calculated with statistical software G'Power version 3.1."||-.094|-.261|<.0001
72346239|NCT04302545|144215329|OTHER||Odds Ratio (OR)|-211.776|||<|0.0001|TWO_SIDED|95.0|-290.7|-132.84|||Regression, Linear|||||-132.84|-290.70|<0.0001
72346240|NCT04302545|144215330|OTHER||Odds Ratio (OR)|0.0||||1|TWO_SIDED|95.0|-3.634|3.634|||Regression, Linear|||Null Hypothsis:Cystoinflation is ineffective to prevent bladder injury in adhesions of previous C-section.The cystoinflation was to be cosidered ineffective if proportion of bladder injury in study group was less than %0% of the control.The power of the study for bladder injury prevention was.988,calculated with statistical software G'Power version3.1.||3.634|-3.634|1
72346241|NCT04302545|144215331|OTHER||Odds Ratio (OR)|-1.093||||0.001|TWO_SIDED|95.0|-1.708|-0.479|||Regression, Linear|||||-.479|-1.708|.001
72346242|NCT04302545|144215332|OTHER||Odds Ratio (OR)|-0.15|||<|0.0001|TWO_SIDED|95.0|-0.226|-0.073|||Regression, Linear|||||-0.073|-0.226|<0.0001
72346243|NCT04302545|144215333|OTHER||Odds Ratio (OR)|-0.103||||0.003|TWO_SIDED|95.0|-0.171|-0.035|||Regression, Linear|||||-0.035|-0.171|0.003
72346244|NCT04302545|144215334|OTHER||Odds Ratio (OR)|0.654||||0.336|TWO_SIDED|95.0|-0.682|1.991|||Regression, Linear|||||1.991|-0.682|.336
72346245|NCT04302545|144215335|OTHER||Odds Ratio (OR)|-0.393||||0.021|TWO_SIDED|95.0|-0.725|-0.06|||Regression, Linear|||||-0.06|-0.725|.021
72346246|NCT04302545|144215336|OTHER||Odds Ratio (OR)|-1.89|||<|0.0001|TWO_SIDED|95.0|-2.813|-0.963|||Regression, Linear|||||-0.963|-2.813|<0.0001
72346247|NCT04302545|144215337|OTHER||Odds Ratio (OR)|-1.318|||<|0.0001|TWO_SIDED|95.0|-2.021|-0.614|||Regression, Linear|||||-0.614|-2.021|<.0001
72429028|NCT02404493|144368940|SUPERIORITY_OR_OTHER|||||||0.005||||||The significance level threshold level was 0.05.|One sample t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||0.005
72429029|NCT02404493|144368940|SUPERIORITY_OR_OTHER|||||||0.821||||||The significance level threshold level was 0.05.|One sample t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||0.821
72346248|NCT04302545|144215339|OTHER||Odds Ratio (OR)|-0.065||||0.003|TWO_SIDED|95.0|-0.108|-0.023|||Regression, Linear|||||-.023|-.108|.003
72346249|NCT01868334|144215377|SUPERIORITY_OR_OTHER_LEGACY|||||||0.05|||||||Chi-squared|Chi-square tests for comparisons between-arm changes in vaccination rates between Baseline and Year 1 for RCCT study period||||||0.05
72346250|NCT01868334|144215377|SUPERIORITY_OR_OTHER_LEGACY|||||||0.05||||||Cochran-Armitage trend tests for percentage point difference between Baseline and Year 1 for RCCT study period|Cochran-Armitage trend test|||||||0.05
72346251|NCT01868334|144215378|SUPERIORITY_OR_OTHER_LEGACY|||||||0.05|||||||Chi-squared|Chi-square tests for comparisons between-arm changes in vaccination rates between pre and post intervention for Pre-post study period||||||0.05
72346252|NCT01868334|144215378|SUPERIORITY_OR_OTHER_LEGACY|||||||0.05||||||Cochran-Armitage trend tests for difference between pre and post changes in vaccination rates for Pre-Post study period|Cochran-Armitage trend test|||||||0.05
72346253|NCT02951429|144215379|SUPERIORITY||Difference of percentage of participants|3.06||||0.6527|TWO_SIDED|95.0|-11.3|17.97|||Chi-squared|||||17.97|-11.30|0.6527
72346254|NCT02951429|144215380|SUPERIORITY||Hazard Ratio (HR)|0.95||||0.7568|TWO_SIDED|95.0|0.67|1.34|||Log Rank|Log-rank test based on the time to the first event to compare the two treatment arms.||||1.34|0.67|0.7568
72346255|NCT02951429|144215381|SUPERIORITY||Hazard Ratio (HR)|0.89||||0.376|TWO_SIDED|95.0|0.68|1.15|||Log Rank|Log-rank test based on the time to the first event to compare the two treatment arms.||||1.15|0.68|0.3760
72346256|NCT02951429|144215382|SUPERIORITY||Difference (95% CI)|2.85||||0.7046|TWO_SIDED|95.0|-12.13|17.84|||Chi-squared|||||17.84|-12.13|0.7046
72346257|NCT02951429|144215383|SUPERIORITY||Difference (95% CI)|0.94||||0.755|TWO_SIDED|95.0|0.62|1.41|||Log Rank|||||1.41|0.62|0.7550
72346258|NCT02951429|144215384|SUPERIORITY||Hazard Ratio (HR)|1.02||||0.9174|TWO_SIDED|95.0|0.65|1.61|||Log Rank|||||1.61|0.65|0.9174
72346259|NCT02951429|144215385|SUPERIORITY||Hazard Ratio (HR)|1.06||||0.7748|TWO_SIDED|95.0|0.7|1.62|||Log Rank|||||1.62|0.70|0.7748
72346260|NCT02951429|144215386|SUPERIORITY||Hazard Ratio (HR)|0.76||||0.4258|TWO_SIDED|95.0|0.38|1.5|||Log Rank|||||1.50|0.38|0.4258
72346261|NCT02951429|144215388|SUPERIORITY||Hazard Ratio (HR)|0.67||||0.3161|TWO_SIDED|95.0|0.31|1.47|||Log Rank|||||1.47|0.31|0.3161
72346262|NCT02951429|144215398|SUPERIORITY||Difference in mean change from baseline|-206.59||||0.5646|TWO_SIDED|95.0|-920.03|506.85|||Linear Mixed Effects Model|||||506.85|-920.03|0.5646
72346263|NCT02951429|144215399|SUPERIORITY||Median Difference (Final Values)|-3.33||||0.5255|TWO_SIDED|95.0|-9.98|2.36|||ANCOVA|Difference in mean change in total score: -4.22||||2.36|-9.98|0.5255
72346264|NCT02951429|144215400|SUPERIORITY||Median Difference (Final Values)|-6.0||||0.4263|TWO_SIDED|95.0|-18.0|6.0|||ANCOVA|Difference in mean change in total score: -5.07||||6.00|-18.00|0.4263
72346265|NCT01620528|144215406|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|||||||< 0.001
72346266|NCT01620528|144215406|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|||||||< 0.001
72346267|NCT01620528|144215407|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|||||||< 0.001
72346268|NCT01620528|144215407|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|||||||< 0.001
72346269|NCT01620528|144215408|SUPERIORITY||Difference in LS Mean Change|-0.65|STANDARD_ERROR_OF_MEAN|0.155|<|0.001|TWO_SIDED||||||mixed-effects model|||Ranked secondary efficacy endpoint 1 of 7.||||< 0.001
72346270|NCT01620528|144215408|SUPERIORITY||Difference in LS Mean Change|-1.3|STANDARD_ERROR_OF_MEAN|0.156|<|0.001|TWO_SIDED||||||mixed-effects model|||Ranked secondary efficacy endpoint 1 of 7.||||< 0.001
72346271|NCT01620528|144215409|SUPERIORITY||Difference in LS Mean Change|-0.45|STANDARD_ERROR_OF_MEAN|0.074|<|0.001|TWO_SIDED|95.0|||||mixed-effects model|||Ranked secondary efficacy endpoint 2 of 7.||||< 0.001
72346272|NCT01620528|144215409|SUPERIORITY||Difference in Least Squares Mean|-1.32|STANDARD_ERROR_OF_MEAN|0.076|<|0.001|TWO_SIDED||||||mixed-effects model|||Ranked secondary efficacy endpoint 2 of 7.||||< 0.001
72346273|NCT01620528|144215410|SUPERIORITY||Difference in LS Mean Change|-0.16|STANDARD_ERROR_OF_MEAN|0.056||0.004|TWO_SIDED||||||mixed-effects model|||Ranked secondary efficacy endpoint 3 of 7.||||0.004
72346274|NCT01620528|144215410|SUPERIORITY||Least Squares Mean Difference|-0.41|STANDARD_ERROR_OF_MEAN|0.057|<|0.001|TWO_SIDED||||||mixed-effects model|||Ranked secondary efficacy endpoint 3 of 7.||||< 0.001
72346275|NCT01620528|144215411|SUPERIORITY||Difference in LS Mean Change|-0.01|STANDARD_ERROR_OF_MEAN|0.051||0.91|TWO_SIDED||||||mixed-effects model|||Ranked secondary efficacy endpoint 4 of 7.||||0.910
72346276|NCT01620528|144215411|SUPERIORITY||Difference in LS Mean Change|-0.26|STANDARD_ERROR_OF_MEAN|0.051|<|0.001|TWO_SIDED||||||mixed-effects model|||Ranked secondary efficacy endpoint 4 of 7.||||< 0.001
72346277|NCT01620528|144215412|SUPERIORITY||Difference in LS Mean Change|-0.07|STANDARD_ERROR_OF_MEAN|0.056||0.185|TWO_SIDED||||||mixed-effects model|||Ranked secondary efficacy endpoint 5 of 7.||||0.185
72346278|NCT01620528|144215412|SUPERIORITY||Least Squares Mean Difference|-0.28|STANDARD_ERROR_OF_MEAN|0.057|<|0.001|TWO_SIDED||||||mixed-effects model|||Ranked secondary efficacy endpoint 5 of 7.||||< 0.001
72346279|NCT01620528|144215413|SUPERIORITY||Difference in LS Mean Change|-0.09|STANDARD_ERROR_OF_MEAN|0.065||0.144|TWO_SIDED||||||mixed-effects model|||Ranked secondary efficacy endpoint 6 of 7.||||0.144
72346280|NCT01620528|144215413|SUPERIORITY||Difference in LS Mean Change|-0.2|STANDARD_ERROR_OF_MEAN|0.067||0.003|TWO_SIDED||||||mixed-effects model|||Ranked secondary efficacy endpoint 6 of 7.||||0.003
72346281|NCT01620528|144215414|SUPERIORITY||Difference in LS Mean Change|0.03|STANDARD_ERROR_OF_MEAN|0.037||0.424|TWO_SIDED||||||mixed-effects model|||Ranked secondary efficacy endpoint 7 of 7.||||0.424
72346282|NCT01620528|144215414|SUPERIORITY||Difference in LS Mean Change|-0.12|STANDARD_ERROR_OF_MEAN|0.038||0.002|TWO_SIDED||||||mixed-effects model|||Ranked secondary efficacy endpoint 7 of 7.||||0.002
72346283|NCT01620528|144215415|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|||||||< 0.001
72346284|NCT01620528|144215415|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|||||||< 0.001
72346285|NCT01620528|144215416|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|||||||< 0.001
72346286|NCT01620528|144215416|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|||||||< 0.001
72346287|NCT01620528|144215417|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|||||||< 0.001
72346288|NCT01620528|144215417|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|||||||< 0.001
72346289|NCT01620528|144215418|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|||||||< 0.001
72346290|NCT01620528|144215418|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|||||||< 0.001
72346291|NCT01620528|144215419|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|||||||< 0.001
72346292|NCT01620528|144215419|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|||||||< 0.001
72346293|NCT01620528|144215420|SUPERIORITY|||||||0.103|||||||Regression, Logistic|||||||0.103
72346294|NCT01620528|144215420|SUPERIORITY|||||||0.023|||||||Regression, Logistic|||||||0.023
72346295|NCT01620528|144215421|SUPERIORITY|||||||0.031|||||||Regression, Logistic|||||||0.031
72346296|NCT01620528|144215421|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|||||||< 0.001
72346297|NCT01620528|144215422|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|||||||< 0.001
72346298|NCT01620528|144215422|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|||||||< 0.001
72346299|NCT01620528|144215423|SUPERIORITY|||||||0.005|||||||Regression, Logistic|||||||0.005
72346300|NCT01620528|144215423|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|||||||< 0.001
72346301|NCT01620528|144215424|SUPERIORITY|||||||0.008|||||||Regression, Logistic|||||||0.008
72346302|NCT01620528|144215424|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|||||||< 0.001
72346303|NCT01620528|144215425|SUPERIORITY|||||||0.306|||||||Regression, Logistic|||||||0.306
72346304|NCT01620528|144215425|SUPERIORITY|||||||0.239|||||||Regression, Logistic|||||||0.239
72346305|NCT01620528|144215426|SUPERIORITY|||||||0.855|||||||Regression, Logistic|||||||0.855
72346306|NCT01620528|144215426|SUPERIORITY|||||||0.012|||||||Regression, Logistic|||||||0.012
72346307|NCT01620528|144215427|SUPERIORITY|||||||0.01|||||||Regression, Logistic|||||||0.010
72346308|NCT01620528|144215427|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|||||||< 0.001
72346309|NCT01620528|144215428|SUPERIORITY|||||||0.061|||||||Regression, Logistic|||||||0.061
72346310|NCT01620528|144215428|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|||||||< 0.001
72346311|NCT01620528|144215429|SUPERIORITY|||||||0.126|||||||Regression, Logistic|||||||0.126
72346312|NCT01620528|144215429|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|||||||< 0.001
72346313|NCT01620528|144215430|SUPERIORITY||LS Mean of Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|97.5|-0.65|-0.34|||mixed-effects model|||||-0.34|-0.65|< 0.001
72346314|NCT01620528|144215430|SUPERIORITY||LS Mean of Difference|-0.65|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|97.5|-0.81|-0.49|||mixed-effects model|||||-0.49|-0.81|< 0.001
72346315|NCT01620528|144215431|SUPERIORITY||LS Mean of Difference|-0.64|STANDARD_ERROR_OF_MEAN|0.067|<|0.001|TWO_SIDED|97.5|-0.79|-0.49|||mixed-effects model|||||-0.49|-0.79|< 0.001
72346316|NCT01620528|144215431|SUPERIORITY||LS Mean of Difference|-1.36|STANDARD_ERROR_OF_MEAN|0.068|<|0.001|TWO_SIDED|97.5|-1.51|-1.2|||mixed-effects model|||||-1.20|-1.51|< 0.001
72346317|NCT01620528|144215432|SUPERIORITY||LS Mean of Difference|-0.68|STANDARD_ERROR_OF_MEAN|0.068|<|0.001|TWO_SIDED|97.5|-0.83|-0.53|||mixed-effects model|||||-0.53|-0.83|< 0.001
72346318|NCT01620528|144215432|SUPERIORITY||LS Mean of Difference|-1.39|STANDARD_ERROR_OF_MEAN|0.069|<|0.001|TWO_SIDED|97.5|-1.54|-1.23|||mixed-effects model|||||-1.23|-1.54|< 0.001
72346319|NCT01620528|144215433|SUPERIORITY||LS Mean of Difference|-0.65|STANDARD_ERROR_OF_MEAN|0.071|<|0.001|TWO_SIDED|97.5|-0.81|-0.49|||mixed-effects model|||||-0.49|-0.81|< 0.001
72346320|NCT01620528|144215433|SUPERIORITY||LS Mean of Difference|-1.32|STANDARD_ERROR_OF_MEAN|0.072|<|0.001|TWO_SIDED|97.5|-1.49|-1.16|||mixed-effects model|||||-1.16|-1.49|< 0.001
72346321|NCT01620528|144215434|SUPERIORITY||LS Mean of Difference|-0.59|STANDARD_ERROR_OF_MEAN|0.071|<|0.001|TWO_SIDED|97.5|-0.75|-0.43|||mixed-effects model|||||-0.43|-0.75|< 0.001
72346322|NCT01620528|144215434|SUPERIORITY||LS Mean of Difference|-1.41|STANDARD_ERROR_OF_MEAN|0.072|<|0.001|TWO_SIDED|97.5|-1.58|-1.25|||mixed-effects model|||||-1.25|-1.58|< 0.001
72346323|NCT01620528|144215435|SUPERIORITY||LS Mean of Difference|-24.07|STANDARD_ERROR_OF_MEAN|3.288|<|0.001|TWO_SIDED|97.5|-31.45|-16.69|||mixed-effects model|||||-16.69|-31.45|< 0.001
72346324|NCT01620528|144215435|SUPERIORITY||LS Mean of Difference|-31.01|STANDARD_ERROR_OF_MEAN|3.299|<|0.001|TWO_SIDED|97.5|-38.41|-23.6|||mixed-effects model|||||-23.60|-38.41|< 0.001
72346325|NCT01620528|144215436|SUPERIORITY||LS Mean of Difference|-30.79|STANDARD_ERROR_OF_MEAN|3.107||-30.79|TWO_SIDED|97.5|-37.77|-23.82|||mixed-effects model|||||-23.82|-37.77|-30.79
72346326|NCT01620528|144215436|SUPERIORITY||LS Mean of Difference|-63.78|STANDARD_ERROR_OF_MEAN|3.148|<|0.001|TWO_SIDED|97.5|-70.85|-56.71|||mixed-effects model|||||-56.71|-70.85|< 0.001
72346327|NCT01620528|144215437|SUPERIORITY||LS Mean of Difference|-32.21|STANDARD_ERROR_OF_MEAN|3.177|<|0.001|TWO_SIDED|97.5|-39.35|-25.08|||mixed-effects model|||||-25.08|-39.35|< 0.001
72346328|NCT01620528|144215437|SUPERIORITY||LS Mean of Difference|-64.94|STANDARD_ERROR_OF_MEAN|3.23|<|0.001|TWO_SIDED|97.5|-72.19|-57.68|||mixed-effects model|||||-57.68|-72.19|< 0.001
72346329|NCT01620528|144215438|SUPERIORITY||LS Mean of Difference|-29.94|STANDARD_ERROR_OF_MEAN|3.272|<|0.001|TWO_SIDED|97.5|-37.28|-22.59|||mixed-effects model|||||-22.59|-37.28|< 0.001
72346330|NCT01620528|144215438|SUPERIORITY||LS Mean of Difference|-61.9|STANDARD_ERROR_OF_MEAN|3.356|<|0.001|TWO_SIDED|97.5|-69.44|-54.36|||mixed-effects model|||||-54.36|-69.44|< 0.001
72346331|NCT01620528|144215439|SUPERIORITY||LS Mean of Difference|-28.63|STANDARD_ERROR_OF_MEAN|3.26|<|0.001|TWO_SIDED|97.5|-35.96|-21.31|||mixed-effects model|||||-21.31|-35.96|< 0.001
72346332|NCT01620528|144215439|SUPERIORITY||LS Mean of Difference|-66.5|STANDARD_ERROR_OF_MEAN|3.321|<|0.001|TWO_SIDED|97.5|-73.95|-59.04|||mixed-effects model|||||-59.04|-73.95|< 0.001
72346333|NCT01620528|144215440|SUPERIORITY||LS Mean of Difference|-21.39|STANDARD_ERROR_OF_MEAN|3.479|<|0.001|TWO_SIDED|97.5|-29.2|-13.57|||mixed-effects model|||||-13.57|-29.20|< 0.001
72346334|NCT01620528|144215440|SUPERIORITY||LS Mean of Difference|-60.78|STANDARD_ERROR_OF_MEAN|3.557|<|0.001|TWO_SIDED|97.5|-68.77|-52.79|||mixed-effects model|||||-52.79|-68.77|< 0.001
72346335|NCT01620528|144215441|SUPERIORITY||LS Mean of Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.036||0.111|TWO_SIDED|97.5|-0.14|0.02|||mixed-effects model|||||0.02|-0.14|0.111
72346336|NCT01620528|144215441|SUPERIORITY||LS Mean of Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.036||0.008|TWO_SIDED|97.5|-0.18|-0.01|||mixed-effects model|||||-0.01|-0.18|0.008
72346337|NCT01620528|144215442|SUPERIORITY||LS Mean of Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.045||0.092|TWO_SIDED|97.5|-0.18|0.02|||mixed-effects model|||||0.02|-0.18|0.092
72346338|NCT01620528|144215442|SUPERIORITY||LS Mean of Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.045|<|0.001|TWO_SIDED|97.5|-0.28|-0.08|||mixed-effects model|||||-0.08|-0.28|< 0.001
72346339|NCT01620528|144215443|SUPERIORITY||LS Mean of Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.05||0.017|TWO_SIDED|97.5|-0.23|-0.01|||mixed-effects model|||||-0.01|-0.23|0.017
72346340|NCT01620528|144215443|SUPERIORITY||LS Mean of Difference|-0.29|STANDARD_ERROR_OF_MEAN|0.05|<|0.001|TWO_SIDED|97.5|-0.41|-0.18|||mixed-effects model|||||-0.18|-0.41|< 0.001
72346341|NCT01620528|144215444|SUPERIORITY||LS Mean of Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.053|<|0.001|TWO_SIDED|97.5|-0.31|-0.07|||mixed-effects model|||||-0.07|-0.31|< 0.001
72346342|NCT01620528|144215444|SUPERIORITY||LS Mean of Difference|-0.39|STANDARD_ERROR_OF_MEAN|0.054|<|0.001|TWO_SIDED|97.5|-0.51|-0.27|||mixed-effects model|||||-0.27|-0.51|< 0.001
72346343|NCT01620528|144215445|SUPERIORITY||LS Mean of Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.053||0.004|TWO_SIDED|97.5|-0.27|-0.03|||mixed-effects model|||||-0.03|-0.27|0.004
72346344|NCT01620528|144215445|SUPERIORITY||LS Mean of Difference|-0.39|STANDARD_ERROR_OF_MEAN|0.054|<|0.001|TWO_SIDED|97.5|-0.52|-0.27|||mixed-effects model|||||-0.27|-0.52|< 0.001
72346345|NCT01620528|144215446|SUPERIORITY||LS Mean of Difference|-6.23|STANDARD_ERROR_OF_MEAN|2.748||0.024|TWO_SIDED|97.5|-12.4|-0.06|||mixed-effects model|||||-0.06|-12.40|0.024
72346346|NCT01620528|144215446|SUPERIORITY||LS Mean of Difference|-7.72|STANDARD_ERROR_OF_MEAN|2.756||0.005|TWO_SIDED|97.5|-13.9|-1.53|||mixed-effects model|||||-1.53|-13.90|0.005
72346347|NCT01620528|144215447|SUPERIORITY||LS Mean of Difference|-5.69|STANDARD_ERROR_OF_MEAN|3.226||0.078|TWO_SIDED|97.5|-12.93|1.56|||mixed-effects model|||||1.56|-12.93|0.078
72346348|NCT01620528|144215447|SUPERIORITY||LS Mean of Difference|-13.72|STANDARD_ERROR_OF_MEAN|3.249|<|0.001|TWO_SIDED|97.5|-21.01|-6.42|||mixed-effects model|||||-6.42|-21.01|< 0.001
72346349|NCT01620528|144215448|SUPERIORITY||LS Mean of Difference|-8.47|STANDARD_ERROR_OF_MEAN|3.475||0.015|TWO_SIDED|97.5|-16.27|-0.66|||mixed-effects model|||||-0.66|-16.27|0.015
72346350|NCT01620528|144215448|SUPERIORITY||LS Mean of Difference|-22.49|STANDARD_ERROR_OF_MEAN|3.514|<|0.001|TWO_SIDED|97.5|-30.38|-14.6|||mixed-effects model|||||-14.60|-30.38|< 0.001
72346351|NCT01620528|144215449|SUPERIORITY||LS Mean of Difference|-14.11|STANDARD_ERROR_OF_MEAN|3.673|<|0.001|TWO_SIDED|97.5|-22.36|-5.87|||mixed-effects model|||||-5.87|-22.36|< 0.001
72346352|NCT01620528|144215449|SUPERIORITY||LS Mean of Difference|-30.41|STANDARD_ERROR_OF_MEAN|3.729|<|0.001|TWO_SIDED|97.5|-38.78|-22.04|||mixed-effects model|||||-22.04|-38.78|< 0.001
72346353|NCT01620528|144215450|SUPERIORITY||LS Mean of Difference|-11.55|STANDARD_ERROR_OF_MEAN|3.736||0.002|TWO_SIDED|97.5|-19.94|-3.16|||mixed-effects model|||||-3.16|-19.94|0.002
72346354|NCT01620528|144215450|SUPERIORITY||LS Mean of Difference|-29.68|STANDARD_ERROR_OF_MEAN|3.788|<|0.001|TWO_SIDED|97.5|-38.19|-21.18|||mixed-effects model|||||-21.18|-38.19|< 0.001
72346355|NCT01620528|144215451|SUPERIORITY||LS Mean of Difference|-12.37|STANDARD_ERROR_OF_MEAN|3.805||0.001|TWO_SIDED|97.5|-20.92|-3.83|||mixed-effects model|||||-3.83|-20.92|0.001
72346356|NCT01620528|144215451|SUPERIORITY||LS Mean of Difference|-29.97|STANDARD_ERROR_OF_MEAN|3.868|<|0.001|TWO_SIDED|97.5|-38.66|-21.28|||mixed-effects model|||||-21.28|-38.66|< 0.001
72346357|NCT01620528|144215452|SUPERIORITY||LS Mean of Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.052||0.038|TWO_SIDED|97.5|-0.22|0.01|||mixed-effects model|||||0.01|-0.22|0.038
72346358|NCT01620528|144215452|SUPERIORITY||LS Mean of Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.053||0.488|TWO_SIDED|97.5|-0.16|0.08|||mixed-effects model|||||0.08|-0.16|0.488
72346359|NCT01620528|144215453|SUPERIORITY||LS Mean of Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.06||0.252|TWO_SIDED|97.5|-0.2|0.07|||mixed-effects model|||||0.07|-0.20|0.252
72346360|NCT01620528|144215453|SUPERIORITY||LS Mean of Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.061||0.058|TWO_SIDED|97.5|-0.25|0.02|||mixed-effects model|||||0.02|-0.25|0.058
72346361|NCT01620528|144215454|SUPERIORITY||LS Mean of Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.069||0.009|TWO_SIDED|97.5|-0.34|-0.03|||mixed-effects model|||||-0.03|-0.34|0.009
72346362|NCT01620528|144215454|SUPERIORITY||LS Mean of Difference|-0.34|STANDARD_ERROR_OF_MEAN|0.071|<|0.001|TWO_SIDED|97.5|-0.5|-0.18|||mixed-effects model|||||-0.18|-0.50|< 0.001
72346363|NCT01620528|144215455|SUPERIORITY||LS Mean of Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.073||0.06|TWO_SIDED|97.5|-0.3|0.03|||mixed-effects model|||||0.03|-0.30|0.060
72346364|NCT01620528|144215455|SUPERIORITY||LS Mean of Difference|-0.27|STANDARD_ERROR_OF_MEAN|0.076|<|0.001|TWO_SIDED|97.5|-0.44|-0.1|||mixed-effects model|||||-0.10|-0.44|< 0.001
72346365|NCT01620528|144215456|SUPERIORITY||LS Mean of Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.074||0.118|TWO_SIDED|97.5|-0.28|0.05|||mixed-effects model|||||0.05|-0.28|0.118
72346366|NCT01620528|144215456|SUPERIORITY||LS Mean of Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.078|<|0.001|TWO_SIDED|97.5|-0.48|-0.13|||mixed-effects model|||||-0.13|-0.48|< 0.001
72346367|NCT01620528|144215457|SUPERIORITY||LS Mean of Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.044||0.313|TWO_SIDED|97.5|-0.14|0.05|||mixed-effects model|||||0.05|-0.14|0.313
72346368|NCT01620528|144215457|SUPERIORITY||LS Mean of Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.044||0.006|TWO_SIDED|97.5|-0.22|-0.02|||mixed-effects model|||||-0.02|-0.22|0.006
72346369|NCT01620528|144215458|SUPERIORITY||LS Mean of Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.047||0.519|TWO_SIDED|97.5|-0.13|0.07|||mixed-effects model|||||0.07|-0.13|0.519
72346370|NCT01620528|144215458|SUPERIORITY||LS Mean of Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.047|<|0.001|TWO_SIDED|97.5|-0.32|-0.11|||mixed-effects model|||||-0.11|-0.32|< 0.001
72346371|NCT01620528|144215459|SUPERIORITY||LS Mean of Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.053||0.037|TWO_SIDED|97.5|-0.23|0.01|||mixed-effects model|||||0.01|-0.23|0.037
72346372|NCT01620528|144215459|SUPERIORITY||LS Mean of Difference|-0.29|STANDARD_ERROR_OF_MEAN|0.053|<|0.001|TWO_SIDED|97.5|-0.41|-0.17|||mixed-effects model|||||-0.17|-0.41|< 0.001
72346373|NCT01620528|144215460|SUPERIORITY||LS Mean of Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.053||0.2|TWO_SIDED|97.5|-0.19|0.05|||mixed-effects model|||||0.05|-0.19|0.200
72346374|NCT01620528|144215460|SUPERIORITY||LS Mean of Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.054|<|0.001|TWO_SIDED|97.5|-0.42|-0.18|||mixed-effects model|||||-0.18|-0.42|< 0.001
72346375|NCT01620528|144215461|SUPERIORITY||LS Mean of Difference|-0.53|STANDARD_ERROR_OF_MEAN|0.094|<|0.001|TWO_SIDED|95.0|-0.72|-0.34|||ANOVA|||||-0.34|-0.72|< 0.001
72346376|NCT01620528|144215461|SUPERIORITY||LS Mean of Difference|-0.74|STANDARD_ERROR_OF_MEAN|0.095|<|0.001|TWO_SIDED|95.0|-0.93|-0.56|||ANOVA|||||-0.56|-0.93|< 0.001
72346377|NCT01620528|144215462|SUPERIORITY||LS Mean of Difference|-0.39|STANDARD_ERROR_OF_MEAN|0.098|<|0.001|TWO_SIDED|95.0|-0.58|-0.19|||ANOVA|||||-0.19|-0.58|< 0.001
72346378|NCT01620528|144215462|SUPERIORITY||LS Mean of Difference|-1.02|STANDARD_ERROR_OF_MEAN|0.099|<|0.001|TWO_SIDED|95.0|-1.21|-0.82|||ANOVA|||||-0.82|-1.21|< 0.001
72346379|NCT01620528|144215463|SUPERIORITY||LS Mean of Difference|-0.61|STANDARD_ERROR_OF_MEAN|0.101|<|0.001|TWO_SIDED|95.0|-0.81|-0.41|||ANOVA|||||-0.41|-0.81|< 0.001
72346380|NCT01620528|144215463|SUPERIORITY||LS Mean of Difference|-1.12|STANDARD_ERROR_OF_MEAN|0.102|<|0.001|TWO_SIDED|95.0|-1.32|-0.92|||ANOVA|||||-0.92|-1.32|< 0.001
72346381|NCT01620528|144215464|SUPERIORITY||LS Mean of Difference|-0.63|STANDARD_ERROR_OF_MEAN|0.106|<|0.001|TWO_SIDED|95.0|-0.83|-0.42|||ANOVA|||||-0.42|-0.83|< 0.001
72346382|NCT01620528|144215464|SUPERIORITY||LS Mean of Difference|-1.26|STANDARD_ERROR_OF_MEAN|0.107|<|0.001|TWO_SIDED|95.0|-1.47|-1.05|||ANOVA|||||-1.05|-1.47|< 0.001
72346383|NCT01620528|144215465|SUPERIORITY||LS Mean of Difference|-0.69|STANDARD_ERROR_OF_MEAN|0.111|<|0.001|TWO_SIDED|95.0|-0.91|-0.48|||ANOVA|||||-0.48|-0.91|< 0.001
72346384|NCT01620528|144215465|SUPERIORITY||LS Mean of Difference|-1.32|STANDARD_ERROR_OF_MEAN|0.112|<|0.001|TWO_SIDED|95.0|-1.54|-1.1|||ANOVA|||||-1.10|-1.54|< 0.001
72346385|NCT01620528|144215466|SUPERIORITY||LS Mean of Difference|-0.72|STANDARD_ERROR_OF_MEAN|0.122|<|0.001|TWO_SIDED|95.0|-0.96|-0.48|||ANOVA|||||-0.48|-0.96|< 0.001
72346386|NCT01620528|144215466|SUPERIORITY||LS Mean of Difference|-1.35|STANDARD_ERROR_OF_MEAN|0.123|<|0.001|TWO_SIDED|95.0|-1.59|-1.11|||ANOVA|||||-1.11|-1.59|< 0.001
72346387|NCT01620528|144215467|SUPERIORITY||LS Mean of Difference|-0.28|STANDARD_ERROR_OF_MEAN|0.109||0.011|TWO_SIDED|95.0|-0.52|-0.03|||mixed-effects model|||||-0.03|-0.52|0.011
72346388|NCT01620528|144215467|SUPERIORITY||LS Mean of Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.11|<|0.001|TWO_SIDED|97.5|-0.65|-0.16|||mixed-effects model|||||-0.16|-0.65|< 0.001
72346389|NCT01620528|144215468|SUPERIORITY||LS Mean of Difference|-0.47|STANDARD_ERROR_OF_MEAN|0.137|<|0.001|TWO_SIDED|97.5|-0.77|-0.16|||mixed-effects model|||||-0.16|-0.77|<0.001
72346390|NCT01620528|144215468|SUPERIORITY||LS Mean of Difference|-0.96|STANDARD_ERROR_OF_MEAN|0.138||-0.96|TWO_SIDED|97.5|-1.27|-0.65|||mixed-effects model|||||-0.65|-1.27|-0.96
72346391|NCT01620528|144215469|SUPERIORITY||LS Mean of Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.163|<|0.001|TWO_SIDED|97.5|-1.17|-0.44|||mixed-effects model|||||-0.44|-1.17|< 0.001
72346392|NCT01620528|144215469|SUPERIORITY||LS Mean of Difference|-1.61|STANDARD_ERROR_OF_MEAN|0.165|<|0.001|TWO_SIDED|97.5|-1.98|-1.24|||mixed-effects model|||||-1.24|-1.98|< 0.001
72346393|NCT01620528|144215470|SUPERIORITY||LS Mean of Difference|-0.68|STANDARD_ERROR_OF_MEAN|0.167|<|0.001|TWO_SIDED|97.5|-1.05|-0.3|||mixed-effects model|||||-0.30|-1.05|< 0.001
72346394|NCT01620528|144215470|SUPERIORITY||LS Mean of Difference|-1.61|STANDARD_ERROR_OF_MEAN|0.17|<|0.001|TWO_SIDED|97.5|-1.99|-1.23|||mixed-effects model|||||-1.23|-1.99|< 0.001
72346395|NCT01620528|144215471|SUPERIORITY||LS Mean of Difference|-0.65|STANDARD_ERROR_OF_MEAN|0.176|<|0.001|TWO_SIDED|97.5|-1.04|-0.25|||mixed-effects model|||||-0.25|-1.04|< 0.001
72346396|NCT01620528|144215471|SUPERIORITY||LS Mean of Difference|-1.6|STANDARD_ERROR_OF_MEAN|0.179|<|0.001|TWO_SIDED|97.5|-2.0|-1.2|||mixed-effects model|||||-1.20|-2.00|< 0.001
72346397|NCT01620528|144215472|SUPERIORITY||Difference in LS Means|-6.29|STANDARD_ERROR_OF_MEAN|1.57|<|0.001|TWO_SIDED|95.0|-9.37|-3.21|||ANCOVA|||||-3.21|-9.37|< 0.001
72346398|NCT01620528|144215472|SUPERIORITY||Difference in LS Means|-9.76|STANDARD_ERROR_OF_MEAN|1.6|<|0.001|TWO_SIDED|95.0|-12.91|-6.61|||ANCOVA|||||-6.61|-12.91|< 0.001
72346399|NCT01620528|144215473|SUPERIORITY||Difference in LS Means|-9.28|STANDARD_ERROR_OF_MEAN|1.72|<|0.001|TWO_SIDED|95.0|-12.66|-5.91|||ANCOVA|||||-5.91|-12.66|< 0.001
72346400|NCT01620528|144215473|SUPERIORITY||Difference in LS Means|-18.75|STANDARD_ERROR_OF_MEAN|1.77|<|0.001|TWO_SIDED|95.0|-22.22|-15.27|||ANCOVA|||||-15.27|-22.22|< 0.001
72346401|NCT01620528|144215474|SUPERIORITY||Difference in LS Means|-12.57|STANDARD_ERROR_OF_MEAN|1.99|<|0.001|TWO_SIDED|95.0|-16.48|-8.66|||ANCOVA|||||-8.66|-16.48|< 0.001
72346402|NCT01620528|144215474|SUPERIORITY||Difference in LS Means|-25.1|STANDARD_ERROR_OF_MEAN|2.04|<|0.001|TWO_SIDED|95.0|-29.12|-21.09|||ANCOVA|||||-21.09|-29.12|< 0.001
72346403|NCT01620528|144215475|SUPERIORITY||LS Mean of Difference|-0.78|STANDARD_ERROR_OF_MEAN|1.94||0.685|TWO_SIDED|95.0|-4.59|3.02|||ANCOVA|||||3.02|-4.59|0.685
72346404|NCT01620528|144215475|SUPERIORITY||Difference in LS Means|-5.04|STANDARD_ERROR_OF_MEAN|2.03||0.013|TWO_SIDED|95.0|-9.04|-1.05|||ANCOVA|||||-1.05|-9.04|0.013
72346405|NCT01620528|144215476|SUPERIORITY||Difference in LS Means|-4.74|STANDARD_ERROR_OF_MEAN|2.39||0.047|TWO_SIDED|95.0|-9.43|-0.05|||ANCOVA|||||-0.05|-9.43|0.047
72346406|NCT01620528|144215476|SUPERIORITY||Difference in LS Means|-13.86|STANDARD_ERROR_OF_MEAN|2.56|<|0.001|TWO_SIDED|95.0|-18.89|-8.84|||ANCOVA|||||-8.84|-18.89|< 0.001
72346407|NCT01620528|144215477|SUPERIORITY||Difference in LS Means|-4.71|STANDARD_ERROR_OF_MEAN|2.91||0.107|TWO_SIDED|95.0|-10.43|1.02|||ANCOVA|||||1.02|-10.43|0.107
72346408|NCT01620528|144215477|SUPERIORITY||Difference in LS Means|-17.51|STANDARD_ERROR_OF_MEAN|3.06|<|0.001|TWO_SIDED|95.0|-23.52|-11.5|||ANCOVA|||||-11.50|-23.52|< 0.001
72346409|NCT01620528|144215478|SUPERIORITY||Difference in LS Means|0.12|STANDARD_ERROR_OF_MEAN|0.37||0.741|TWO_SIDED|95.0|-0.61|0.85|||ANCOVA|||||0.85|-0.61|0.741
72346410|NCT01620528|144215478|SUPERIORITY||Difference in LS Means|-1.16|STANDARD_ERROR_OF_MEAN|0.38||0.002|TWO_SIDED|95.0|-1.9|-0.42|||ANCOVA|||||-0.42|-1.90|0.002
72346411|NCT01620528|144215479|SUPERIORITY||Difference in LS Means|-0.47|STANDARD_ERROR_OF_MEAN|0.35||0.172|TWO_SIDED|95.0|-1.16|0.21|||ANCOVA|||||0.21|-1.16|0.172
72429030|NCT02404493|144368940|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|0.351||0.06|TWO_SIDED|95.0|-1.435|0.032||The significance level threshold level was 0.05.|ANCOVA|Change from baseline as response, baseline score as covariate and treatment as factor.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.032|-1.435|0.060
72346412|NCT01620528|144215479|SUPERIORITY||Difference in LS Means|-1.27|STANDARD_ERROR_OF_MEAN|0.36|<|0.001|TWO_SIDED|95.0|-1.97|-0.57|||ANCOVA|||||-0.57|-1.97|< 0.001
72346413|NCT01620528|144215480|SUPERIORITY||LS Mean of Difference|-1.05|STANDARD_ERROR_OF_MEAN|0.43||0.016|TWO_SIDED|95.0|-1.9|-0.19|||ANCOVA|||||-0.19|-1.90|0.016
72346414|NCT01620528|144215480|SUPERIORITY||Difference in LS Means|-1.78|STANDARD_ERROR_OF_MEAN|0.44|<|0.001|TWO_SIDED|95.0|-2.65|-0.91|||ANCOVA|||||-0.91|-2.65|< 0.001
72346415|NCT01620528|144215481|SUPERIORITY||Difference in LS Means|-0.77|STANDARD_ERROR_OF_MEAN|0.44||0.08|TWO_SIDED|95.0|-1.63|0.09|||ANCOVA|||||0.09|-1.63|0.080
72346416|NCT01620528|144215481|SUPERIORITY||Difference in LS Means|-1.37|STANDARD_ERROR_OF_MEAN|0.45||0.003|TWO_SIDED|95.0|-2.25|-0.48|||ANCOVA|||||-0.48|-2.25|0.003
72346417|NCT01620528|144215482|SUPERIORITY||Difference in LS Means|-0.65|STANDARD_ERROR_OF_MEAN|0.4||0.106|TWO_SIDED|95.0|-1.44|0.14|||ANCOVA|||||0.14|-1.44|0.106
72346418|NCT01620528|144215482|SUPERIORITY||Difference in LS Means|-1.85|STANDARD_ERROR_OF_MEAN|0.42|<|0.001|TWO_SIDED|95.0|-2.67|-1.02|||ANCOVA|||||-1.02|-2.67|< 0.001
72346419|NCT01620528|144215483|SUPERIORITY||Difference in LS Means|-0.75|STANDARD_ERROR_OF_MEAN|0.62||0.232|TWO_SIDED|95.0|-1.97|0.48|||ANCOVA|||||0.48|-1.97|0.232
72346420|NCT01620528|144215483|SUPERIORITY||Difference in LS Means|-2.21|STANDARD_ERROR_OF_MEAN|0.65|<|0.001|TWO_SIDED|95.0|-3.48|-0.93|||ANCOVA|||||-0.93|-3.48|< 0.001
72346421|NCT01620528|144215484|SUPERIORITY||Difference in LS Means|-0.92|STANDARD_ERROR_OF_MEAN|0.37||0.013|TWO_SIDED|95.0|-1.65|-0.2|||ANCOVA|||||-0.20|-1.65|0.013
72346422|NCT01620528|144215484|SUPERIORITY||Difference in LS Means|-1.62|STANDARD_ERROR_OF_MEAN|0.37|<|0.001|TWO_SIDED|95.0|-2.35|-0.9|||ANCOVA|||||-0.90|-2.35|< 0.001
72346423|NCT01620528|144215485|SUPERIORITY||Difference in LS Means|-1.33|STANDARD_ERROR_OF_MEAN|0.47||0.005|TWO_SIDED|95.0|-2.24|-0.41|||ANCOVA|||||-0.41|-2.24|0.005
72346424|NCT01620528|144215485|SUPERIORITY||Difference in LS Means|-1.64|STANDARD_ERROR_OF_MEAN|0.47|<|0.001|TWO_SIDED|95.0|-2.56|-0.71|||ANCOVA|||||-0.71|-2.56|< 0.001
72346425|NCT01620528|144215486|SUPERIORITY||Difference in LS Means|-1.63|STANDARD_ERROR_OF_MEAN|0.46|<|0.001|TWO_SIDED|95.0|-2.53|-0.72|||ANCOVA|||||-0.72|-2.53|< 0.001
72346426|NCT01620528|144215486|SUPERIORITY||Difference in LS Means|-2.1|STANDARD_ERROR_OF_MEAN|0.47|<|0.001|TWO_SIDED|95.0|-3.02|-1.19|||ANCOVA|||||-1.19|-3.02|< 0.001
72346427|NCT01620528|144215487|SUPERIORITY||Difference in LS Means|-1.21|STANDARD_ERROR_OF_MEAN|0.42||0.004|TWO_SIDED|95.0|-2.05|-0.38|||ANCOVA|||||-0.38|-2.05|0.004
72346428|NCT01620528|144215487|SUPERIORITY||Difference in LS Means|-2.23|STANDARD_ERROR_OF_MEAN|0.42|<|0.001|TWO_SIDED|95.0|-3.06|-1.4|||ANCOVA|||||-1.40|-3.06|< 0.001
72346429|NCT01620528|144215488|SUPERIORITY||Difference in LS Means|-0.97|STANDARD_ERROR_OF_MEAN|0.39||0.013|TWO_SIDED|95.0|-1.74|-0.2|||ANCOVA|||||-0.20|-1.74|0.013
72346430|NCT01620528|144215488|SUPERIORITY||Difference in LS Means|-1.81|STANDARD_ERROR_OF_MEAN|0.39|<|0.001|TWO_SIDED|95.0|-2.58|-1.04|||ANCOVA|||||-1.04|-2.58|< 0.001
72346431|NCT01620528|144215489|SUPERIORITY||Difference in LS Means|-1.28|STANDARD_ERROR_OF_MEAN|0.48||0.007|TWO_SIDED|95.0|-2.22|-0.34|||ANCOVA|||||-0.34|-2.22|0.007
72346432|NCT01620528|144215489|SUPERIORITY||Difference in LS Means|-2.49|STANDARD_ERROR_OF_MEAN|0.48|<|0.001|TWO_SIDED|95.0|-3.44|-1.54|||ANCOVA|||||-1.54|-3.44|< 0.001
72346433|NCT01620528|144215490|SUPERIORITY||Difference in LS Means|-0.86|STANDARD_ERROR_OF_MEAN|0.87||0.326|TWO_SIDED|95.0|-2.57|0.85|||ANCOVA|||||0.85|-2.57|0.326
72346434|NCT01620528|144215490|SUPERIORITY||Difference in LS Means|-1.93|STANDARD_ERROR_OF_MEAN|0.89||0.031|TWO_SIDED|95.0|-3.67|-0.18|||ANCOVA|||||-0.18|-3.67|0.031
72346435|NCT01620528|144215491|SUPERIORITY||Difference in LS Means|-1.41|STANDARD_ERROR_OF_MEAN|0.88||0.107|TWO_SIDED|95.0|-3.13|0.31|||ANCOVA|||||0.31|-3.13|0.107
72346436|NCT01620528|144215491|SUPERIORITY||Difference in LS Means|-3.52|STANDARD_ERROR_OF_MEAN|0.9|<|0.001|TWO_SIDED|95.0|-5.28|-1.75|||ANCOVA|||||-1.75|-5.28|< 0.001
72346437|NCT01620528|144215492|SUPERIORITY||Difference in LS Means|-1.01|STANDARD_ERROR_OF_MEAN|0.82||0.219|TWO_SIDED|95.0|-2.63|0.6|||ANCOVA|||||0.60|-2.63|0.219
72346438|NCT01620528|144215492|SUPERIORITY||Difference in LS Means|-2.93|STANDARD_ERROR_OF_MEAN|0.84|<|0.001|TWO_SIDED|95.0|-4.59|-1.28|||ANCOVA|||||-1.28|-4.59|< 0.001
72346439|NCT01620528|144215493|SUPERIORITY||Difference in LS Means|-1.6|STANDARD_ERROR_OF_MEAN|0.72||0.026|TWO_SIDED|95.0|-3.01|-0.19|||ANCOVA|||||-0.19|-3.01|0.026
72346440|NCT01620528|144215493|SUPERIORITY||Difference in LS Means|-3.89|STANDARD_ERROR_OF_MEAN|0.74|<|0.001|TWO_SIDED|95.0|-5.34|-2.43|||ANCOVA|||||-2.43|-5.34|< 0.001
72346441|NCT01620528|144215494|SUPERIORITY||Difference in LS Means|-0.51|STANDARD_ERROR_OF_MEAN|0.76||0.502|TWO_SIDED|95.0|-2.0|0.98|||ANCOVA|||||0.98|-2.00|0.502
72346442|NCT01620528|144215494|SUPERIORITY||Difference in LS Means|-3.13|STANDARD_ERROR_OF_MEAN|0.8|<|0.001|TWO_SIDED|95.0|-4.7|-1.56|||ANCOVA|||||-1.56|-4.70|< 0.001
72346443|NCT01620528|144215495|SUPERIORITY||Difference in LS Means|-1.36|STANDARD_ERROR_OF_MEAN|0.85||0.108|TWO_SIDED|95.0|-3.02|0.3|||ANCOVA|||||0.30|-3.02|0.108
72346444|NCT01620528|144215495|SUPERIORITY||Difference in LS Means|-4.47|STANDARD_ERROR_OF_MEAN|0.88|<|0.001|TWO_SIDED|95.0|-6.19|-2.74|||ANCOVA|||||-2.74|-6.19|< 0.001
72346445|NCT01620528|144215496|SUPERIORITY||Difference in LS Means|-1.19|STANDARD_ERROR_OF_MEAN|0.36||0.001|TWO_SIDED|95.0|-1.9|-0.48|||ANCOVA|||||-0.48|-1.90|0.001
72346446|NCT01620528|144215496|SUPERIORITY||Difference in LS Means|-1.05|STANDARD_ERROR_OF_MEAN|0.36||0.004|TWO_SIDED|95.0|-1.76|-0.34|||ANCOVA|||||-0.34|-1.76|0.004
72346447|NCT01620528|144215497|SUPERIORITY||Difference in LS Means|-0.76|STANDARD_ERROR_OF_MEAN|0.38||0.045|TWO_SIDED|95.0|-1.49|-0.02|||mixed-effects model|||||-0.02|-1.49|0.045
72346448|NCT01620528|144215497|SUPERIORITY||Difference in LS Means|-1.06|STANDARD_ERROR_OF_MEAN|0.38||0.006|TWO_SIDED|95.0|-1.81|-0.31|||ANCOVA|||||-0.31|-1.81|0.006
72346449|NCT01620528|144215498|SUPERIORITY||Difference in LS Means|-0.54|STANDARD_ERROR_OF_MEAN|0.33||0.103|TWO_SIDED|95.0|-1.19|0.11|||ANCOVA|||||0.11|-1.19|0.103
72429031|NCT02404493|144368941|SUPERIORITY_OR_OTHER|||||||0.007||||||The significance level threshold level was 0.05.|One sample t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||0.007
72346450|NCT01620528|144215498|SUPERIORITY||Difference in LS Means|-0.98|STANDARD_ERROR_OF_MEAN|0.34||0.003|TWO_SIDED|95.0|-1.64|-0.32|||ANCOVA|||||-0.32|-1.64|0.003
72346451|NCT01620528|144215499|SUPERIORITY||Difference in LS Means|-0.31|STANDARD_ERROR_OF_MEAN|0.36||0.39|TWO_SIDED|95.0|-1.01|0.4|||ANCOVA|||||0.40|-1.01|0.390
72346452|NCT01620528|144215499|SUPERIORITY||Difference in LS Means|-1.05|STANDARD_ERROR_OF_MEAN|0.36||0.003|TWO_SIDED|95.0|-1.75|-0.35|||ANCOVA|||||-0.35|-1.75|0.003
72346453|NCT01620528|144215500|SUPERIORITY||Difference in LS Means|-0.2|STANDARD_ERROR_OF_MEAN|0.27||0.46|TWO_SIDED|95.0|-0.72|0.32|||ANCOVA|||||0.32|-0.72|0.460
72346454|NCT01620528|144215500|SUPERIORITY||Difference in LS Means|-1.04|STANDARD_ERROR_OF_MEAN|0.27|<|0.001|TWO_SIDED|95.0|-1.57|-0.52|||ANCOVA|||||-0.52|-1.57|< 0.001
72346455|NCT01620528|144215501|SUPERIORITY||LS Mean of Difference|-0.59|STANDARD_ERROR_OF_MEAN|0.35||0.095|TWO_SIDED|95.0|-1.28|0.1|||ANCOVA|||||0.10|-1.28|0.095
72346456|NCT01620528|144215501|SUPERIORITY||Difference in LS Means|-1.3|STANDARD_ERROR_OF_MEAN|0.36|<|0.001|TWO_SIDED|95.0|-2.01|-0.59|||ANCOVA|||||-0.59|-2.01|< 0.001
72346457|NCT01620528|144215502|SUPERIORITY||Difference in LS Means|-0.71|STANDARD_ERROR_OF_MEAN|0.97||0.462|TWO_SIDED|95.0|-2.61|1.19|||ANCOVA|||||1.19|-2.61|0.462
72346458|NCT01620528|144215502|SUPERIORITY||Difference in LS Means|-3.23|STANDARD_ERROR_OF_MEAN|0.98||0.001|TWO_SIDED|95.0|-5.16|-1.3|||ANCOVA|||||-1.30|-5.16|0.001
72346459|NCT01620528|144215503|SUPERIORITY||Difference in LS Means|-2.02|STANDARD_ERROR_OF_MEAN|0.97||0.039|TWO_SIDED|95.0|-3.93|-0.11|||ANCOVA|||||-0.11|-3.93|0.039
72346460|NCT01620528|144215503|SUPERIORITY||Difference in LS Means|-4.86|STANDARD_ERROR_OF_MEAN|1.0|<|0.001|TWO_SIDED|95.0|-6.82|-2.9|||ANCOVA|||||-2.90|-6.82|< 0.001
72346461|NCT01620528|144215504|SUPERIORITY||Difference in LS Means|-2.2|STANDARD_ERROR_OF_MEAN|1.03||0.032|TWO_SIDED|95.0|-4.21|-0.18|||ANCOVA|||||-0.18|-4.21|0.032
72346462|NCT01620528|144215504|SUPERIORITY||Difference in LS Means|-4.91|STANDARD_ERROR_OF_MEAN|1.04|<|0.001|TWO_SIDED|95.0|-6.95|-2.86|||ANCOVA|||||-2.86|-6.95|< 0.001
72346463|NCT01620528|144215505|SUPERIORITY||Difference in LS Means|-2.42|STANDARD_ERROR_OF_MEAN|0.94||0.01|TWO_SIDED|95.0|-4.26|-0.58|||ANCOVA|||||-0.58|-4.26|0.010
72346464|NCT01620528|144215505|SUPERIORITY||Difference in LS Means|-5.25|STANDARD_ERROR_OF_MEAN|0.96|<|0.001|TWO_SIDED|95.0|-7.14|-3.36|||ANCOVA|||||-3.36|-7.14|< 0.001
72346465|NCT01620528|144215506|SUPERIORITY||Difference in LS Means|-1.17|STANDARD_ERROR_OF_MEAN|0.94||0.215|TWO_SIDED|95.0|-3.02|0.68|||ANCOVA|||||0.68|-3.02|0.215
72346466|NCT01620528|144215506|SUPERIORITY||Difference in LS Means|-5.13|STANDARD_ERROR_OF_MEAN|0.98|<|0.001|TWO_SIDED|95.0|-7.06|-3.2|||ANCOVA|||||-3.20|-7.06|< 0.001
72346467|NCT01620528|144215507|SUPERIORITY||Difference in LS Means|-2.25|STANDARD_ERROR_OF_MEAN|1.16||0.053|TWO_SIDED|95.0|-4.53|0.03|||ANCOVA|||||0.03|-4.53|0.053
72346468|NCT01620528|144215507|SUPERIORITY||Difference in LS Means|-6.79|STANDARD_ERROR_OF_MEAN|1.21|<|0.001|TWO_SIDED|95.0|-9.17|-4.41|||ANCOVA|||||-4.41|-9.17|< 0.001
72346469|NCT01620528|144215508|SUPERIORITY||Difference in LS Means|-2.12|STANDARD_ERROR_OF_MEAN|0.57|<|0.001|TWO_SIDED|95.0|-3.24|-1.01|||ANCOVA|||||-1.01|-3.24|< 0.001
72346470|NCT01620528|144215508|SUPERIORITY||Difference in LS Means|-2.6|STANDARD_ERROR_OF_MEAN|0.57|<|0.001|TWO_SIDED|95.0|-3.71|-1.49|||ANCOVA|||||-1.49|-3.71|< 0.001
72346471|NCT01620528|144215509|SUPERIORITY||Difference in LS Means|-2.09|STANDARD_ERROR_OF_MEAN|0.67||0.002|TWO_SIDED|95.0|-3.4|-0.78|||ANCOVA|||||-0.78|-3.40|0.002
72346472|NCT01620528|144215509|SUPERIORITY||Difference in LS Means|-2.65|STANDARD_ERROR_OF_MEAN|0.68|<|0.001|TWO_SIDED|95.0|-3.98|-1.32|||ANCOVA|||||-1.32|-3.98|< 0.001
72346473|NCT01620528|144215510|SUPERIORITY||Difference in LS Means|-2.17|STANDARD_ERROR_OF_MEAN|0.62|<|0.001|TWO_SIDED|95.0|-3.39|-0.95|||ANCOVA|||||-0.95|-3.39|< 0.001
72346474|NCT01620528|144215510|SUPERIORITY||Difference in LS Means|-3.0|STANDARD_ERROR_OF_MEAN|0.63|<|0.001|TWO_SIDED|95.0|-4.23|-1.76|||ANCOVA|||||-1.76|-4.23|< 0.001
72346475|NCT01620528|144215511|SUPERIORITY||Difference in LS Means|-1.54|STANDARD_ERROR_OF_MEAN|0.64||0.017|TWO_SIDED|95.0|-2.8|-0.27|||ANCOVA|||||-0.27|-2.80|0.017
72346476|NCT01620528|144215511|SUPERIORITY||Difference in LS Means|-3.24|STANDARD_ERROR_OF_MEAN|0.64|<|0.001|TWO_SIDED|95.0|-4.5|-1.98|||ANCOVA|||||-1.98|-4.50|< 0.001
72346477|NCT01620528|144215512|SUPERIORITY||Difference in LS Means|-1.14|STANDARD_ERROR_OF_MEAN|0.55||0.038|TWO_SIDED|95.0|-2.22|-0.07|||ANCOVA|||||-0.07|-2.22|0.038
72346478|NCT01620528|144215512|SUPERIORITY||Difference in LS Means|-2.83|STANDARD_ERROR_OF_MEAN|0.55|<|0.001|TWO_SIDED|95.0|-3.91|-1.74|||ANCOVA|||||-1.74|-3.91|< 0.001
72346479|NCT01620528|144215513|SUPERIORITY||Difference in LS Means|-1.83|STANDARD_ERROR_OF_MEAN|0.66||0.006|TWO_SIDED|95.0|-3.13|-0.54|||ANCOVA|||||-0.54|-3.13|0.006
72346480|NCT01620528|144215513|SUPERIORITY||Difference in LS Means|-3.75|STANDARD_ERROR_OF_MEAN|0.67|<|0.001|TWO_SIDED|95.0|-5.06|-2.44|||ANCOVA|||||-2.44|-5.06|< 0.001
72346481|NCT02106403|144215526|SUPERIORITY_OR_OTHER||Mean Difference (Net)|5.46||||0.0659|TWO_SIDED|95.0|-0.37|11.29|||ANOVA|Calculated from mixed effect ANOVA analysis with treatment and assessment site as fixed effects and subject as random effect.|Difference was calculated as the prototype disinfectant spray formulation minus negative control such that a positive difference showed improved cooling in the prototype disinfectant spray formulation.|The null and alternative hypotheses were: H0: product difference was null vs. Ha: product difference was not null.||11.29|-0.37|0.0659
72346482|NCT02106403|144215526|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.99||||0.0928|TWO_SIDED|95.0|-0.84|10.81|||ANCOVA|Calculated from mixed effect ANOVA analysis with treatment and assessment site as fixed effects and subject as random effect.|Difference was calculated as the reference product minus negative control such that a positive difference showed improved cooling in the reference product.|The null and alternative hypotheses were: H0: product difference was null vs. Ha: product difference was not null.||10.81|-0.84|0.0928
72346483|NCT02106403|144215526|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.48||||0.8711|TWO_SIDED|95.0|-5.35|6.31|||ANOVA|Calculated from mixed effect ANOVA analysis with treatment and assessment site as fixed effects and subject as random effect.|Difference was calculated as the prototype disinfectant spray formulation minus reference product such that a positive difference showed improved cooling in the prototype disinfectant spray formulation.|The null and alternative hypotheses were: H0: product difference was null vs. Ha: product difference was not null.||6.31|-5.35|0.8711
72346484|NCT02106403|144215527|SUPERIORITY_OR_OTHER||Mean Difference (Net)|11.43||||0.0016|TWO_SIDED|95.0|4.43|18.42|||ANOVA|Calculated from mixed effect ANOVA analysis with treatment and assessment site as fixed effects and subject as random effect.|Difference was calculated as the prototype disinfectant spray formulation minus negative control such that a positive difference showed improved cooling in the prototype disinfectant spray formulation.|The null and alternative hypotheses were: H0: product difference was null vs. Ha: product difference was not null.||18.42|4.43|0.0016
72346485|NCT02106403|144215527|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.69||||0.6323|TWO_SIDED|95.0|-5.31|8.69|||ANOVA|Calculated from mixed effect ANOVA analysis with treatment and assessment site as fixed effects and subject as random effect.|Difference was calculated as the reference product minus negative control such that a positive difference showed improved cooling in the reference product.|The null and alternative hypotheses were: H0: product difference was null vs. Ha: product difference was not null.||8.69|-5.31|0.6323
72346486|NCT02106403|144215527|SUPERIORITY_OR_OTHER||Mean Difference (Net)|9.73||||0.0069|TWO_SIDED|95.0|2.74|16.73|||ANOVA|Calculated from mixed effect ANOVA analysis with treatment and assessment site as fixed effects and subject as random effect.|Difference was calculated as the prototype disinfectant spray formulation minus reference product such that a positive difference showed improved cooling in the prototype disinfectant spray formulation.|The null and alternative hypotheses were: H0: product difference was null vs. Ha: product difference was not null.||16.73|2.74|0.0069
72346487|NCT02106403|144215528|SUPERIORITY_OR_OTHER||Mean Difference (Net)|12.13|||<|0.0001|TWO_SIDED|95.0|6.23|18.04|||ANOVA|Calculated from mixed effect ANOVA analysis with treatment and assessment site as fixed effects and subject as random effect.|Difference was calculated as the prototype disinfectant spray formulation minus negative control such that a positive difference showed improved cooling in the prototype disinfectant spray formulation.|The null and alternative hypotheses were: H0: product difference was null vs. Ha: product difference was not null.||18.04|6.23|<0.0001
72346488|NCT02106403|144215528|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.18||||0.4645|TWO_SIDED|95.0|-8.09|3.72|||ANOVA|Calculated from mixed effect ANOVA analysis with treatment and assessment site as fixed effects and subject as random effect.|Difference was calculated as the reference product minus negative control such that a positive difference showed improved cooling in the reference product.|The null and alternative hypotheses were: H0: product difference was null vs. Ha: product difference was not null.||3.72|-8.09|0.4645
72346489|NCT02106403|144215528|SUPERIORITY_OR_OTHER||Mean Difference (Net)|14.32|||<|0.0001|TWO_SIDED|95.0|8.41|20.22|||ANOVA|Calculated from mixed effect ANOVA analysis with treatment and assessment site as fixed effects and subject as random effect.|Difference was calculated as the prototype disinfectant spray formulation minus reference product such that a positive difference showed improved cooling in the prototype disinfectant spray formulation.|The null and alternative hypotheses were: H0: product difference was null vs. Ha: product difference was not null.||20.22|8.41|<0.0001
72346490|NCT02106403|144215529|SUPERIORITY_OR_OTHER||Mean Difference (Net)|6.41||||0.0357|TWO_SIDED|95.0|0.44|12.38|||ANOVA|Calculated from mixed effect ANOVA analysis with treatment and assessment site as fixed effects and subject as random effect.|Difference was calculated as the prototype disinfectant spray formulation minus negative control such that a positive difference showed improved cooling in the prototype disinfectant spray formulation.|The null and alternative hypotheses were: H0: product difference was null vs. Ha: product difference was not null.||12.38|0.44|0.0357
72346491|NCT02106403|144215529|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.02||||0.503|TWO_SIDED|95.0|-3.95|8.0|||ANOVA|Calculated from mixed effect ANOVA analysis with treatment and assessment site as fixed effects and subject as random effect.|Difference was calculated as the reference product minus negative control such that a positive difference showed improved cooling in the reference product.|The null and alternative hypotheses were: H0: product difference was null vs. Ha: product difference was not null.||8.00|-3.95|0.5030
72346492|NCT02106403|144215529|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.39||||0.1482|TWO_SIDED|95.0|-1.59|10.36|||ANOVA|Calculated from mixed effect ANOVA analysis with treatment and assessment site as fixed effects and subject as random effect.|Difference was calculated as the prototype disinfectant spray formulation minus reference product such that a positive difference showed improved cooling in the prototype disinfectant spray formulation.|The null and alternative hypotheses were: H0: product difference was null vs. Ha: product difference was not null.||10.36|-1.59|0.1482
72346493|NCT01496846|144215531|SUPERIORITY|||||||0.901|||||||Chi-squared|We used the Chi-Square Test or Fisher's Exact test on the raw data depending on the number of data points in the table cells.||||||.901
72346494|NCT01496846|144215531|SUPERIORITY|||||||0.004|||||||Chi-squared|We used the Chi-Square Test or Fisher's Exact test on the raw data depending on the number of data points in the table cells.||||||.004
72346495|NCT01496846|144215532|SUPERIORITY|||||||0.437|||||||Chi-squared|We used the Chi-Square Test or Fisher's Exact test on the raw data depending on the number of data points in the table cells.||||||.437
72346496|NCT02024724|144215539|SUPERIORITY||Median Difference (Final Values)|-30.0||||0.196|TWO_SIDED|95.0|-45.0|10.0|||Chi-squared|||||10.00|-45.00|.196
72346497|NCT02019875|144215540|SUPERIORITY||Mean Difference (Final Values)|-1.5||||0.884|TWO_SIDED|95.0|-21.2|18.3|||Mixed Models Analysis|||||18.3|-21.2|0.884
72346498|NCT02019875|144215540|SUPERIORITY||Mean Difference (Final Values)|0.6||||0.955|TWO_SIDED|95.0|-19.5|20.7|||Mixed Models Analysis|||||20.7|-19.5|0.955
72429032|NCT02404493|144368941|SUPERIORITY_OR_OTHER|||||||0.051||||||The significance level threshold level was 0.05.|One sample t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||0.051
72429033|NCT02404493|144368941|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.188||0.926|TWO_SIDED|95.0|-0.41|0.375||The significance level threshold level was 0.05.|ANCOVA|Change from baseline as response, baseline score as covariate and treatment as factor.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.375|-0.410|0.926
72429034|NCT02404493|144368942|SUPERIORITY_OR_OTHER|||||||0.58||||||The significance level threshold level was 0.05.|One sample t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||0.580
72346499|NCT02019875|144215540|SUPERIORITY||Mean Difference (Final Values)|-6.4||||0.53|TWO_SIDED|95.0|-26.5|13.6|||Mixed Models Analysis|||||13.6|-26.5|0.53
72346500|NCT02019875|144215540|SUPERIORITY||Mean Difference (Final Values)|-7.9||||0.434|TWO_SIDED|95.0|-27.6|11.9|||Mixed Models Analysis|||||11.9|-27.6|0.434
72346501|NCT02019875|144215540|SUPERIORITY||Mean Difference (Final Values)|-2.8||||0.796|TWO_SIDED|95.0|-24.2|18.6|||Mixed Models Analysis|||||18.6|-24.2|0.796
72346502|NCT02019875|144215541|SUPERIORITY||Mean Difference (Final Values)|-1.2||||0.62|TWO_SIDED|95.0|-6.0|3.6|||Mixed Models Analysis|||||3.6|-6.0|0.62
72346503|NCT02019875|144215541|SUPERIORITY||Mean Difference (Final Values)|1.8||||0.482|TWO_SIDED|95.0|-3.1|6.7|||Mixed Models Analysis|||||6.7|-3.1|0.482
72346504|NCT02019875|144215541|SUPERIORITY||Mean Difference (Final Values)|1.5||||0.559|TWO_SIDED|95.0|-3.4|6.4|||Mixed Models Analysis|||||6.4|-3.4|0.559
72346505|NCT02019875|144215541|SUPERIORITY||Mean Difference (Final Values)|3.7||||0.138|TWO_SIDED|95.0|-1.2|8.5|||Mixed Models Analysis|||||8.5|-1.2|0.138
72346506|NCT02019875|144215541|SUPERIORITY||Mean Difference (Final Values)|-1.9||||0.477|TWO_SIDED|95.0|-7.1|3.3|||Mixed Models Analysis|||||3.3|-7.1|0.477
72346507|NCT02019875|144215542|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.98|TWO_SIDED|95.0|-11.0|11.3|||Mixed Models Analysis|||||11.3|-11.0|0.98
72346508|NCT02019875|144215542|SUPERIORITY||Mean Difference (Final Values)|1.4||||0.81|TWO_SIDED|95.0|-10.0|12.7|||Mixed Models Analysis|||||12.7|-10.0|0.81
72346509|NCT02019875|144215542|SUPERIORITY||Mean Difference (Final Values)|0.7||||0.91|TWO_SIDED|95.0|-10.8|12.2|||Mixed Models Analysis|||||12.2|-10.8|0.91
72346510|NCT02019875|144215542|SUPERIORITY||Mean Difference (Final Values)|2.4||||0.68|TWO_SIDED|95.0|-8.9|13.8|||Mixed Models Analysis|||||13.8|-8.9|0.68
72346511|NCT02019875|144215542|SUPERIORITY||Mean Difference (Final Values)|0.3||||0.96|TWO_SIDED|95.0|-11.9|12.6|||Mixed Models Analysis|||||12.6|-11.9|0.96
72346512|NCT02019875|144215543|SUPERIORITY||Mean Difference (Final Values)|-1.1||||0.17|TWO_SIDED|95.0|-2.7|0.5|||Mixed Models Analysis|||||0.5|-2.7|0.17
72346513|NCT02019875|144215543|SUPERIORITY||Mean Difference (Final Values)|0.6||||0.44|TWO_SIDED|95.0|-1.0|2.2|||Mixed Models Analysis|||||2.2|-1.0|0.44
72346514|NCT02019875|144215543|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.94|TWO_SIDED|95.0|-1.7|1.6|||Mixed Models Analysis|||||1.6|-1.7|0.94
72346515|NCT02019875|144215543|SUPERIORITY||Mean Difference (Final Values)|3.7|||<|0.0001|TWO_SIDED|95.0|2.1|5.2|||Mixed Models Analysis|||||5.2|2.1|<0.0001
72346516|NCT02019875|144215543|SUPERIORITY||Mean Difference (Final Values)|3.9|||<|0.0001|TWO_SIDED|95.0|2.2|5.6|||Mixed Models Analysis|||||5.6|2.2|<0.0001
72346517|NCT02019875|144215544|SUPERIORITY||Mean Difference (Final Values)|-0.008||||0.43|TWO_SIDED|95.0|-0.027|0.012|||Mixed Models Analysis|||||0.012|-0.027|0.43
72346518|NCT02019875|144215544|SUPERIORITY||Mean Difference (Final Values)|-0.017||||0.09|TWO_SIDED|95.0|-0.037|0.003|||Mixed Models Analysis|||||0.003|-0.037|0.09
72346519|NCT02019875|144215544|SUPERIORITY||Mean Difference (Final Values)|-0.011||||0.29|TWO_SIDED|95.0|-0.031|0.009|||Mixed Models Analysis|||||0.009|-0.031|0.29
72346520|NCT02019875|144215544|SUPERIORITY||Mean Difference (Final Values)|-0.005||||0.61|TWO_SIDED|95.0|-0.025|0.015|||Mixed Models Analysis|||||0.015|-0.025|0.61
72346521|NCT02019875|144215544|SUPERIORITY||Mean Difference (Final Values)|-0.008||||0.46|TWO_SIDED|95.0|-0.03|0.014|||Mixed Models Analysis|||||0.014|-0.03|0.46
72346522|NCT02019875|144215545|SUPERIORITY||Mean Difference (Final Values)|-12.6||||0.53|TWO_SIDED|95.0|-52.0|26.7|||Mixed Models Analysis|||||26.7|-52.0|0.53
72346523|NCT02019875|144215545|SUPERIORITY||Mean Difference (Final Values)|-44.5||||0.03|TWO_SIDED|95.0|-84.5|-4.5|||Mixed Models Analysis|||||-4.5|-84.5|0.03
72346524|NCT02019875|144215545|SUPERIORITY||Mean Difference (Final Values)|-7.2||||0.72|TWO_SIDED|95.0|-47.3|32.8|||Mixed Models Analysis|||||32.8|-47.3|0.72
72346525|NCT02019875|144215545|SUPERIORITY||Mean Difference (Final Values)|2.8||||0.89|TWO_SIDED|95.0|-36.6|42.2|||Mixed Models Analysis|||||42.2|-36.6|0.89
72346526|NCT02019875|144215545|SUPERIORITY||Mean Difference (Final Values)|38.0||||0.08|TWO_SIDED|95.0|-4.7|80.6|||Mixed Models Analysis|||||80.6|-4.7|0.08
72346527|NCT02019875|144215546|SUPERIORITY||Mean Difference (Final Values)|2.8||||0.96|TWO_SIDED|95.0|-104.5|110.2|||Mixed Models Analysis|||||110.2|-104.5|0.96
72429035|NCT02404493|144368942|SUPERIORITY_OR_OTHER|||||||0.363||||||The significance level threshold level was 0.05.|One sample t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||0.363
72346528|NCT02019875|144215546|SUPERIORITY||Mean Difference (Final Values)|15.0||||0.79|TWO_SIDED|95.0|-94.2|124.2|||Mixed Models Analysis|||||124.2|-94.2|0.79
72346529|NCT02019875|144215546|SUPERIORITY||Mean Difference (Final Values)|71.3||||0.2|TWO_SIDED|95.0|-37.9|180.5|||Mixed Models Analysis|||||180.5|-37.9|0.20
72429036|NCT02404493|144368942|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.2||0.539|TWO_SIDED|95.0|-0.531|0.286||The significance level threshold level was 0.05.|ANCOVA|Change from baseline as response, baseline score as covariate and treatment as factor.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.286|-0.531|0.539
72346530|NCT02019875|144215546|SUPERIORITY||Mean Difference (Final Values)|-2.7||||0.96|TWO_SIDED|95.0|-110.1|104.7|||Mixed Models Analysis|||||104.7|-110.1|0.96
72346531|NCT02019875|144215546|SUPERIORITY||Mean Difference (Final Values)|51.8||||0.38|TWO_SIDED|95.0|-64.7|168.2|||Mixed Models Analysis|||||168.2|-64.7|0.38
72346532|NCT03202134|144215547|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
72346533|NCT03202134|144215548|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
72346534|NCT03202134|144215549|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
72346535|NCT03202134|144215550|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
72346536|NCT03202134|144215551|SUPERIORITY|||||||0.048|||||||Wilcoxon (Mann-Whitney)|||||||0.048
72346537|NCT00966550|144215553|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|95.0|||||Mixed Models Analysis|||||||<0.0001
72346538|NCT01128946|144215554|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|23.06|||<|0.0001|TWO_SIDED|95.0|19.63|26.48||No adjustments made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment, study period and subject (random effect).|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered population means for treatments in comparison, to be equal with respect to percent SMH recovery. Statistical tests were 2-sided with a significance level of 0.05.||26.48|19.63|<0.0001
72346539|NCT01128946|144215555|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|10.75|||<|0.0001|TWO_SIDED|95.0|7.33|14.17||No adjustments made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment, study period and subject (random effect).|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered population means for treatments in comparison, to be equal with respect to percent SMH recovery. Statistical tests were 2-sided with a significance level of 0.05.||14.17|7.33|<0.0001
72346540|NCT01128946|144215555|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|12.2|||<|0.0001|TWO_SIDED|95.0|8.74|15.67||No adjustments made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment, study period and subject (random effect).|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered population means for treatments in comparison, to be equal with respect to percent SMH recovery. Statistical tests were 2-sided with a significance level of 0.05.||15.67|8.74|<0.0001
72346541|NCT01128946|144215555|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|12.31|||<|0.0001|TWO_SIDED|95.0|8.9|15.72||No adjustments made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment, study period and subject (random effect).|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered population means for treatments in comparison, to be equal with respect to percent SMH recovery. Statistical tests were 2-sided with a significance level of 0.05.||15.72|8.90|<0.0001
72346542|NCT01128946|144215555|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|1.46||||0.407|TWO_SIDED|95.0|-2.0|4.91||No adjustments made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment, study period and subject (random effect).|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered population means for treatments in comparison, to be equal with respect to percent SMH recovery. Statistical tests were 2-sided with a significance level of 0.05.||4.91|-2.00|0.4070
72346543|NCT01128946|144215555|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-10.85|||<|0.0001|TWO_SIDED|95.0|-14.3|-7.4||No adjustments made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment, study period and subject (random effect).|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered population means for treatments in comparison, to be equal with respect to percent SMH recovery. Statistical tests were 2-sided with a significance level of 0.05.||-7.40|-14.30|<0.0001
72346544|NCT01128946|144215556|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|13.21|||<|0.0001|TWO_SIDED|95.0|11.46|14.96||No adjustments made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment, study period and subject (random effect).|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered population means for treatments in comparison, to be equal with respect to enamel fluoride uptake. Statistical tests were 2-sided with a significance level of 0.05.||14.96|11.46|<0.0001
72346545|NCT01128946|144215556|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|8.79|||<|0.0001|TWO_SIDED|95.0|7.04|10.55||No adjustments made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment, study period and subject (random effect).|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered population means for treatments in comparison, to be equal with respect to enamel fluoride uptake. Statistical tests were 2-sided with a significance level of 0.05.||10.55|7.04|<0.0001
72346546|NCT01128946|144215556|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|8.03|||<|0.0001|TWO_SIDED|95.0|6.25|9.8||No adjustments made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment, study period and subject (random effect).|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered population means for treatments in comparison, to be equal with respect to enamel fluoride uptake. Statistical tests were 2-sided with a significance level of 0.05.||9.80|6.25|<0.0001
72346547|NCT01128946|144215556|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|4.41|||<|0.0001|TWO_SIDED|95.0|2.66|6.16||No adjustments made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment, study period and subject (random effect).|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered population means for treatments in comparison, to be equal with respect to enamel fluoride uptake. Statistical tests were 2-sided with a significance level of 0.05.||6.16|2.66|<0.0001
72346548|NCT01128946|144215556|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.77||||0.3942|TWO_SIDED|95.0|-2.54|1.0||No adjustments made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment, study period and subject (random effect).|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered population means for treatments in comparison, to be equal with respect to enamel fluoride uptake. Statistical tests were 2-sided with a significance level of 0.05.||1.00|-2.54|0.3942
72346549|NCT01128946|144215556|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-5.18|||<|0.0001|TWO_SIDED|95.0|-6.95|-3.41||No adjustments made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment, study period and subject (random effect).|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered population means for treatments in comparison, to be equal with respect to enamel fluoride uptake. Statistical tests were 2-sided with a significance level of 0.05.||-3.41|-6.95|<0.0001
72346550|NCT00621140|144215565|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.69|STANDARD_ERROR_OF_MEAN|0.08|<|0.0001||95.0|-0.85|-0.53|||ANCOVA|||Linagliptin vs. Placebo||-0.53|-0.85|<0.0001
72346551|NCT00621140|144215566|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.46|STANDARD_ERROR_OF_MEAN|0.06|<|0.0001||95.0|-0.58|-0.34|||ANCOVA|||Linagliptin vs. Placebo||-0.34|-0.58|<0.0001
72346552|NCT00621140|144215567|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.61|STANDARD_ERROR_OF_MEAN|0.08|<|0.0001||95.0|-0.76|-0.47|||ANCOVA|||Linagliptin vs. Placebo||-0.47|-0.76|<0.0001
72346553|NCT00621140|144215568|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.66|STANDARD_ERROR_OF_MEAN|0.08|<|0.0001||95.0|-0.82|-0.49|||ANCOVA|||Linagliptin vs. Placebo||-0.49|-0.82|<0.0001
72346554|NCT00621140|144215569|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-23.31|STANDARD_ERROR_OF_MEAN|3.59|<|0.0001||95.0|-30.37|-16.26|||ANCOVA|||Linagliptin vs. Placebo||-16.26|-30.37|<0.0001
72346555|NCT00621140|144215570|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.6|STANDARD_ERROR_OF_MEAN|2.81|<|0.0001||95.0|-23.11|-12.08|||ANCOVA|||Linagliptin vs. Placebo||-12.08|-23.11|<0.0001
72346556|NCT00621140|144215571|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-20.98|STANDARD_ERROR_OF_MEAN|3.17|<|0.0001||95.0|-27.21|-14.75|||ANCOVA|||Linagliptin vs. Placebo||-14.75|-27.21|<0.0001
72346557|NCT00621140|144215572|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-20.36|STANDARD_ERROR_OF_MEAN|3.4|<|0.0001||95.0|-27.05|-13.68|||ANCOVA|||Linagliptin vs. Placebo||-13.68|-27.05|<0.0001
72346558|NCT00621140|144215573|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.869||||0.0006||95.0|1.575|5.225|||Regression, Logistic|||"Linagliptin vs. Placebo~The odds-ratio is based on a logistic regression model including baseline HbA1c and previous antidiabetic medication."||5.225|1.575|0.0006
72346559|NCT00621140|144215575|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.436||||0.0323||95.0|1.078|5.507|||Regression, Logistic|||"Linagliptin vs. Placebo~The odds-ratio is based on a logistic regression model including baseline HbA1c and previous antidiabetic medication."||5.507|1.078|0.0323
72346560|NCT00621140|144215577|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.243|||<|0.0001||95.0|2.665|6.755|||Regression, Logistic|||"Linagliptin vs. Placebo~The odds-ratio is based on a logistic regression model including baseline HbA1c and previous antidiabetic medication."||6.755|2.665|<0.0001
72346561|NCT00621140|144215578|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-58.38|STANDARD_DEVIATION|12.05|<|0.0001||95.0|-82.33|-34.43|||ANCOVA|||Linagliptin vs. Placebo||-34.43|-82.33|<0.0001
72346562|NCT01371734|144215579|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.85||||0.587|TWO_SIDED|95.0|-2.23|3.94|||Mixed-effects model for repeated measure|Hochberg procedure was used to control for multiplicity||Adjusted mean difference = Placebo - DVS SR Low Dose||3.94|-2.23|0.587
72346563|NCT01371734|144215579|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.52||||0.333|TWO_SIDED|95.0|-1.56|4.61|||Mixed-effects model for repeated measure|Hochberg procedure was used to control for multiplicity||Adjusted mean difference = Placebo - DVS SR High Dose||4.61|-1.56|0.333
72346564|NCT01371734|144215580|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.015||||0.923|TWO_SIDED|95.0|-0.29|0.32|||Mixed-effects model for repeated measure|Hochberg procedure was used to control for multiplicity||Adjusted mean difference = Placebo - DVS SR Low Dose||0.32|-0.29|0.923
72346565|NCT01371734|144215580|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.161||||0.302|TWO_SIDED|95.0|-0.14|0.47|||Mixed-effects model for repeated measure|Hochberg procedure was used to control for multiplicity||Adjusted mean difference = Placebo - DVS SR High Dose||0.47|-0.14|0.302
72346566|NCT01371734|144215581|SUPERIORITY_OR_OTHER|||||||0.729|||||||Cochran-Mantel-Haenszel|||Week 1||||0.729
72346567|NCT01371734|144215581|SUPERIORITY_OR_OTHER|||||||0.756|||||||Cochran-Mantel-Haenszel|||Week 1||||0.756
72346568|NCT01371734|144215581|SUPERIORITY_OR_OTHER|||||||0.765|||||||Cochran-Mantel-Haenszel|||Week 2||||0.765
72346569|NCT01371734|144215581|SUPERIORITY_OR_OTHER|||||||0.475|||||||Cochran-Mantel-Haenszel|||Week 2||||0.475
72346570|NCT01371734|144215581|SUPERIORITY_OR_OTHER|||||||0.31|||||||Cochran-Mantel-Haenszel|||Week 3||||0.310
72346571|NCT01371734|144215581|SUPERIORITY_OR_OTHER|||||||0.105|||||||Chi-squared, Corrected|||Week 3||||0.105
72346572|NCT01371734|144215581|SUPERIORITY_OR_OTHER|||||||0.254|||||||Cochran-Mantel-Haenszel|||Week 4||||0.254
72346573|NCT01371734|144215581|SUPERIORITY_OR_OTHER|||||||0.887|||||||Cochran-Mantel-Haenszel|||Week 4||||0.887
72346574|NCT01371734|144215581|SUPERIORITY_OR_OTHER|||||||0.475|||||||Cochran-Mantel-Haenszel|||Week 6||||0.475
72346575|NCT01371734|144215581|SUPERIORITY_OR_OTHER|||||||0.407|||||||Cochran-Mantel-Haenszel|||Week 6||||0.407
72346576|NCT01371734|144215581|SUPERIORITY_OR_OTHER|||||||0.696|||||||Cochran-Mantel-Haenszel|||Week 8||||0.696
72346577|NCT01371734|144215581|SUPERIORITY_OR_OTHER|||||||0.462|||||||Cochran-Mantel-Haenszel|||Week 8||||0.462
72346578|NCT01371734|144215582|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.806||||0.633|TWO_SIDED|95.0|0.333|1.951|||Regression, Logistic|||Week 1||1.951|0.333|0.633
72346579|NCT01371734|144215582|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.561||||0.172|TWO_SIDED|95.0|0.245|1.285|||Regression, Logistic|||Week 1||1.285|0.245|0.172
72346580|NCT01371734|144215582|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.939||||0.826|TWO_SIDED|95.0|0.536|1.644|||Regression, Logistic|||Week 2||1.644|0.536|0.826
72346581|NCT01371734|144215582|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.86||||0.599|TWO_SIDED|95.0|0.489|1.511|||Regression, Logistic|||Week 2||1.511|0.489|0.599
72429037|NCT02404493|144368943|SUPERIORITY_OR_OTHER|||||||0.055||||||The significance level threshold level was 0.05.|One sample t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||0.055
72429038|NCT02404493|144368943|SUPERIORITY_OR_OTHER|||||||0.076||||||The significance level threshold level was 0.05.|One sample t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||0.076
72346582|NCT01371734|144215582|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.713||||0.248|TWO_SIDED|95.0|0.402|1.265|||Regression, Logistic|||Week 3||1.265|0.402|0.248
72346583|NCT01371734|144215582|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.564||||0.048|TWO_SIDED|95.0|0.32|0.995|||Regression, Logistic|||Week 3||0.995|0.320|0.048
72346584|NCT01371734|144215582|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.708||||0.21|TWO_SIDED|95.0|0.412|1.216|||Regression, Logistic|||Week 4||1.216|0.412|0.210
72346585|NCT01371734|144215582|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.964||||0.893|TWO_SIDED|95.0|0.564|1.646|||Regression, Logistic|||Week 4||1.646|0.564|0.893
72346586|NCT01371734|144215582|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.714||||0.228|TWO_SIDED|95.0|0.413|1.235|||Regression, Logistic|||Week 6||1.235|0.413|0.228
72346587|NCT01371734|144215582|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.916||||0.751|TWO_SIDED|95.0|0.531|1.579|||Regression, Logistic|||Week 6||1.579|0.531|0.751
72346588|NCT01371734|144215582|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.974||||0.925|TWO_SIDED|95.0|0.561|1.689|||Regression, Logistic|||Week 8||1.689|0.561|0.925
72346589|NCT01371734|144215582|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.764||||0.342|TWO_SIDED|95.0|0.438|1.331|||Regression, Logistic|||Week 8||1.331|0.438|0.342
72346590|NCT00360568|144215596|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
72346591|NCT00360568|144215597|SUPERIORITY_OR_OTHER|||||||0.394|||||||t-test, 2 sided|||||||0.394
72346592|NCT00360568|144215598|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
72346593|NCT00360568|144215599|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
72346594|NCT00360568|144215600|SUPERIORITY_OR_OTHER|||||||0.055|||||||t-test, 2 sided|||||||0.055
72346595|NCT00360568|144215601|SUPERIORITY_OR_OTHER|||||||0.766|||||||t-test, 2 sided|||||||0.766
72346596|NCT00360568|144215602|SUPERIORITY_OR_OTHER|||||||0.571|||||||t-test, 2 sided|||||||0.571
72346597|NCT00360568|144215603|SUPERIORITY_OR_OTHER|||||||0.583|||||||t-test, 2 sided|||||||0.583
72346598|NCT00360568|144215604|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
72346599|NCT00360568|144215605|SUPERIORITY_OR_OTHER|||||||0.67|||||||t-test, 2 sided|||||||0.670
72346600|NCT00360568|144215606|SUPERIORITY_OR_OTHER|||||||0.341|||||||t-test, 2 sided|||||||0.341
72346601|NCT00360568|144215607|SUPERIORITY_OR_OTHER|||||||0.22|||||||t-test, 2 sided|||||||0.220
72346602|NCT00360568|144215608|SUPERIORITY_OR_OTHER|||||||0.174|||||||t-test, 2 sided|||||||0.174
72346603|NCT00360568|144215609|SUPERIORITY_OR_OTHER|||||||0.259|||||||t-test, 2 sided|||||||0.259
72346604|NCT00360568|144215610|SUPERIORITY_OR_OTHER|||||||0.922|||||||t-test, 2 sided|||||||0.922
72346605|NCT00360568|144215611|SUPERIORITY_OR_OTHER|||||||0.258|||||||t-test, 2 sided|||||||0.258
72346606|NCT00360568|144215612|SUPERIORITY_OR_OTHER|||||||0.104|||||||t-test, 2 sided|||||||0.104
72346607|NCT00360568|144215613|SUPERIORITY_OR_OTHER|||||||0.65|||||||t-test, 2 sided|||||||0.650
72346608|NCT00360568|144215614|SUPERIORITY_OR_OTHER|||||||0.759|||||||t-test, 2 sided|||||||0.759
72346609|NCT00360568|144215615|SUPERIORITY_OR_OTHER|||||||0.459|||||||t-test, 2 sided|||||||0.459
72346610|NCT00360568|144215616|SUPERIORITY_OR_OTHER|||||||0.899|||||||t-test, 2 sided|||||||0.899
72346611|NCT02467842|144215624|NON_INFERIORITY|Non-inferiority of GMTs was concluded if the upper limit of 95% confidence interval of the GMR (active comparator/experimental) was ≤1.5 for each strain.|GMR (pooled TIV/QIV)|1.02|||||TWO_SIDED|95.0|0.94|1.1||||||GMR of A/H1N1 strain (GMTs of pooled TIV/QIV)||1.10|0.94|
72346612|NCT02467842|144215624|NON_INFERIORITY|Non-inferiority of GMTs was concluded if the upper limit of 95% confidence interval of the GMR (active comparator/experimental) was ≤1.5 for each strain.|GMR (pooled TIV/QIV)|0.94|||||TWO_SIDED|95.0|0.87|1.01||||||GMR of A/H3N2 strain (GMTs of pooled TIV/QIV)||1.01|0.87|
72346613|NCT02467842|144215624|NON_INFERIORITY|Non-inferiority of GMTs was concluded if the upper limit of 95% confidence interval of the GMR (active comparator/experimental) was ≤1.5 for each strain.|GMR (TIV/QIV)|0.88|||||TWO_SIDED|95.0|0.82|0.95||||||GMR of B/Yamagata strain (GMTs of TIV/QIV)||0.95|0.82|
72346614|NCT02467842|144215624|NON_INFERIORITY|Non-inferiority of GMTs was concluded if the upper limit of 95% confidence interval of the GMR (active comparator/experimental) was ≤1.5 for each strain.|GMR (TIV/QIV)|0.9|||||TWO_SIDED|95.0|0.83|0.97||||||GMR of A/H1N1 strain (GMTs of TIV/QIV)||0.97|0.83|
72346615|NCT02467842|144215625|NON_INFERIORITY|Non-inferiority of SCR was concluded if the upper limit of 95% confidence interval for Diff. SCR (active comparator minus experimental) ≤10% for each strain.|Difference in percentage|-1.0|||||TWO_SIDED|95.0|-6.07|4.06||||||Diff. SCR of A/H1N1 strain (SCR of pooled TIV minus QIV)||4.06|-6.07|
72346616|NCT02467842|144215625|NON_INFERIORITY|Non-inferiority of SCR was concluded if the upper limit of 95% confidence interval for Diff. SCR (active comparator minus experimental) ≤10% for each strain.|Difference in percentage|-5.02|||||TWO_SIDED|95.0|-10.08|0.04||||||Diff. SCR of A/H3N2 strain (SCR of pooled TIV minus QIV)||0.04|-10.08|
72346617|NCT02467842|144215625|NON_INFERIORITY|Non-inferiority of SCR was concluded if the upper limit of 95% confidence interval for Diff. SCR (active comparator minus experimental) ≤10% for each strain.|Difference in percentage|-7.06|||||TWO_SIDED|95.0|-13.12|-1.0||||||Diff. SCR of B/Yamaga strain (SCR of TIV minus QIV)||-1.00|-13.12|
72346618|NCT02467842|144215625|NON_INFERIORITY|Non-inferiority of SCR was concluded if the upper limit of 95% confidence interval for Diff. SCR (active comparator minus experimental) ≤10% for each strain.|Difference in percentage|-3.09|||||TWO_SIDED|95.0|-9.26|3.09||||||Diff. SCR of B/Victoria (SCR of TIV minus QIV)||3.09|-9.26|
72346619|NCT02467842|144215629|SUPERIORITY|Superiority of GMTs was concluded if the upper limit of 95% confidence interval for GMR (active comparator/experimental) was ≤1.0 for each B strain.|GMR (TIV/QIV)|0.75|||||TWO_SIDED|95.0|0.7|0.81||||||GMR of B/Yamagata strain (GMTs of TIV/QIV)||0.81|0.70|
72346620|NCT02467842|144215629|SUPERIORITY|Superiority of GMTs was concluded if the upper limit of 95% confidence interval for GMR (active comparator/experimental) was ≤1.0 for each B strain.|GMR (TIV/QIV)|0.75|||||TWO_SIDED|95.0|0.69|0.81||||||GMR of B/Victoria (GMTs of TIV/QIV)||0.81|0.69|
72346621|NCT02467842|144215630|SUPERIORITY|Superiority was concluded if the upper limit of 95% confidence interval for Diff. SCR (active comparator-experimental) was ≤0% in each B strain.|Difference in percentage|-18.98|||||TWO_SIDED|95.0|-24.61|-13.36||||||Diff. SCR of B/Yamaga strain (SCR of TIV minus QIV)||-13.36|-24.61|
72346622|NCT02467842|144215630|SUPERIORITY|Superiority was concluded if the upper limit of 95% confidence interval for Diff. SCR (active comparator-experimental) was ≤0% in each B strain.|Difference in percentage|-12.62|||||TWO_SIDED|95.0|-18.79|-6.45||||||Diff. SCR of B/Victoria strain (SCR of TIV minus QIV)||-6.45|-18.79|
72346623|NCT03824587|144215651|SUPERIORITY||Mean Difference (Net)|-0.65|STANDARD_ERROR_OF_MEAN|0.182||0.0004|TWO_SIDED|99.0|-1.13|-0.18|||Mixed Models Analysis|||||-0.18|-1.13|0.0004
72346624|NCT03824587|144215652|SUPERIORITY||Odds Ratio (OR)|2.1||||0.0097|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.0097
72346625|NCT03824587|144215653|SUPERIORITY|||||||0.0027|||||||ANOVA|||||||0.0027
72346626|NCT03824587|144215654|SUPERIORITY|||||||0.0011|||||||ANOVA|||||||0.0011
72346627|NCT00986362|144215655|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.613||||0.679|TWO_SIDED|95.0|0.07|4.509|||Fisher Exact|||||4.509|0.070|0.679
72346628|NCT02611817|144215665|SUPERIORITY||Clopper-Pearson method|13.7||||0.008|TWO_SIDED|95.0|3.8|23.7|||Cochran-Mantel-Haenszel|||P-value was calculated by Cochran-Mantel-Haenszel (CMH) test stratified by electronic data capture (EDC) stratum according to concomitant use of corticosteroids, clinical remission status at Week 6, and previous TNF-alpha antagonist failure/exposed or concomitant immunomodulator use.||23.7|3.8|0.008
72346629|NCT02611817|144215666|SUPERIORITY||Clopper-Pearson method|7.3||||0.167|TWO_SIDED|95.0|-3.0|17.5|||Cochran-Mantel-Haenszel|||P-value was calculated by CMH test stratified by EDC stratum according to concomitant use of corticosteroids, clinical remission status at Week 6, and previous TNF-alpha antagonist failure/exposed or concomitant immunomodulator use.||17.5|-3.0|0.167
72346630|NCT02611817|144215667|SUPERIORITY||Clopper-Pearson method|27.1||||0.002|TWO_SIDED|95.0|11.9|42.3|||Cochran-Mantel-Haenszel|||P-value was calculated by CMH test stratified by EDC stratum according to concomitant use of corticosteroids, clinical remission status at Week 6, and previous TNF-alpha antagonist failure/exposed or concomitant immunomodulator use.||42.3|11.9|0.002
72346631|NCT02611817|144215668|SUPERIORITY||Clopper-Pearson method|4.3||||0.591|TWO_SIDED|95.0|-11.6|20.3|||Cochran-Mantel-Haenszel|||P-value was calculated by CMH test stratified by EDC stratum according to concomitant use of corticosteroids, clinical remission status at Week 6, and previous TNF-alpha antagonist failure/exposed or concomitant immunomodulator use.||20.3|-11.6|0.591
72346632|NCT00931606|144215669|SUPERIORITY||||||>|0.999||||||"P-values greater than 0.999 are reported as \>0.999."|Fisher Exact|Clopper and Pearson exact approach||Overall||||>0.999
72429039|NCT02404493|144368943|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.27||0.682|TWO_SIDED|95.0|-0.672|0.449||The significance level threshold level was 0.05.|ANCOVA|Change from baseline as response, baseline score as covariate and treatment as factor.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.449|-0.672|0.682
72346633|NCT00931606|144215669|SUPERIORITY||||||>|0.999||||||"P-values greater than 0.999 are reported as \>0.999."|Fisher Exact|Clopper and Pearson exact approach||Overall||||>0.999
72346634|NCT00931606|144215669|SUPERIORITY|||||||0.524|||||||Fisher Exact|Clopper and Pearson exact approach||Overall||||0.524
72346635|NCT00931606|144215669|SUPERIORITY||||||>|0.999||||||"P-values greater than 0.999 are reported as \>0.999."|Fisher Exact|Clopper and Pearson exact approach||Overall||||>0.999
72346636|NCT00931606|144215669|SUPERIORITY|||||||0.333|||||||Fisher Exact|Clopper and Pearson exact approach||Weekly Chemotherapy||||0.333
72346637|NCT00931606|144215669|SUPERIORITY|||||||0.333|||||||Fisher Exact|Clopper and Pearson exact approach||Weekly Chemotherapy||||0.333
72346638|NCT00931606|144215669|SUPERIORITY|||||||0.333|||||||Fisher Exact|Clopper and Pearson exact approach||Weekly Chemotherapy||||0.333
72346639|NCT00931606|144215669|SUPERIORITY|||||||0.236|||||||Fisher Exact|Clopper and Pearson exact approach||Less Frequent Chemotherapy||||0.236
72346640|NCT00931606|144215669|SUPERIORITY|||||||0.429|||||||Fisher Exact|Clopper and Pearson exact approach||Less Frequent Chemotherapy||||0.429
72346641|NCT00931606|144215669|SUPERIORITY|||||||0.519|||||||Fisher Exact|Clopper and Pearson exact approach||Less Frequent Chemotherapy||||0.519
72346642|NCT00931606|144215672|SUPERIORITY||||||>|0.999||||||"P-values greater than 0.999 are reported as \>0.999."|Fisher Exact|Clopper and Pearson exact approach||Overall||||>0.999
72346643|NCT00931606|144215672|SUPERIORITY||||||>|0.999||||||"P-values greater than 0.999 are reported as \>0.999."|Fisher Exact|Clopper and Pearson exact approach||Overall||||>0.999
72346644|NCT00931606|144215672|SUPERIORITY||||||>|0.999||||||"P-values greater than 0.999 are reported as \>0.999."|Fisher Exact|Clopper and Pearson exact approach||Less Frequent Chemotherapy||||>0.999
72346645|NCT00931606|144215672|SUPERIORITY||||||>|0.999|||||||Fisher Exact|Clopper and Pearson exact approach||Less Frequent Chemotherapy||||>0.999
72346646|NCT00931606|144215673|SUPERIORITY||||||>|0.999||||||"P-values greater than 0.999, are reported as \>0.999."|Fisher Exact|Clopper and Pearson exact approach||Overall||||>0.999
72346647|NCT00931606|144215673|SUPERIORITY||||||>|0.999||||||"P-values greater than 0.999 are reported as \>0.999."|Fisher Exact|Clopper and Pearson exact approach||Overall||||>0.999
72346648|NCT00931606|144215673|SUPERIORITY|||||||0.206|||||||Fisher Exact|Clopper and Pearson exact approach||Overall||||0.206
72346649|NCT00931606|144215673|SUPERIORITY||||||>|0.999||||||"P-values greater than 0.999 are reported as \>0.999."|Fisher Exact|Clopper and Pearson exact approach||Overall||||>0.999
72429040|NCT02404493|144368944|SUPERIORITY_OR_OTHER|||||||0.004||||||The significance level threshold level was 0.05.|One sample t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||0.004
72429041|NCT02404493|144368944|SUPERIORITY_OR_OTHER|||||||0.025||||||The significance level threshold level was 0.05.|One sample t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||0.025
72346650|NCT00931606|144215673|SUPERIORITY|||||||0.333|||||||Fisher Exact|Clopper and Pearson exact approach||Weekly Chemotherapy||||0.333
72346651|NCT00931606|144215673|SUPERIORITY||||||>|0.999||||||"P-values greater than 0.999, are reported as \>0.999."|Fisher Exact|Clopper and Pearson exact approach||Weekly Chemotherapy||||>0.999
72346652|NCT00931606|144215673|SUPERIORITY||||||>|0.999||||||"P-values greater than 0.999, are reported as \>0.999."|Fisher Exact|Clopper and Pearson exact approach||Weekly Chemotherapy||||>0.999
72346653|NCT00931606|144215673|SUPERIORITY|||||||0.429|||||||Fisher Exact|Clopper and Pearson exact approach||Less Frequent Chemotherapy||||0.429
72346654|NCT00931606|144215673|SUPERIORITY||||||>|0.999||||||"P-values greater than 0.999 are reported as \>0.999."|Fisher Exact|Clopper and Pearson exact approach||Less Frequent Chemotherapy||||>0.999
72346655|NCT00931606|144215673|SUPERIORITY|||||||0.143|||||||Fisher Exact|Clopper and Pearson exact approach||Less Frequent Chemotherapy||||0.143
72346656|NCT00931606|144215673|SUPERIORITY|||||||0.519|||||||Fisher Exact|Clopper and Pearson exact approach||Less Frequent Chemotherapy||||0.519
72346657|NCT00931606|144215674|SUPERIORITY||||||>|0.999||||||"P-values greater than 0.999 are reported as \>0.999."|Fisher Exact|Clopper and Pearson exact approach||Overall||||>0.999
72346658|NCT00931606|144215674|SUPERIORITY||||||>|0.999||||||"P-values greater than 0.999 are reported as \>0.999."|Fisher Exact|Clopper and Pearson exact approach||Overall||||>0.999
72346659|NCT00931606|144215674|SUPERIORITY|||||||0.206|||||||Fisher Exact|Clopper and Pearson exact approach||Overall||||0.206
72346660|NCT00931606|144215674|SUPERIORITY||||||>|0.999||||||"P-values greater than 0.999 are reported as \>0.999."|Fisher Exact|Clopper and Pearson exact approach||Overall||||>0.999
72346661|NCT00931606|144215674|SUPERIORITY|||||||0.333|||||||Fisher Exact|Clopper and Pearson exact approach||Weekly Chemotherapy||||0.333
72346662|NCT00931606|144215674|SUPERIORITY||||||>|0.999||||||"P-values greater than 0.999 are reported as \>0.999."|Fisher Exact|Clopper and Pearson exact approach||Weekly Chemotherapy||||>0.999
72346663|NCT00931606|144215674|SUPERIORITY||||||>|0.999||||||"P-values greater than 0.999 are reported as \>0.999."|Fisher Exact|Clopper and Pearson exact approach||Weekly Chemotherapy||||>0.999
72346664|NCT00931606|144215674|SUPERIORITY|||||||0.429|||||||Fisher Exact|Clopper and Pearson exact approach||Less Frequent Chemotherapy||||0.429
72346665|NCT00931606|144215674|SUPERIORITY||||||>|0.999||||||"P-values greater than 0.999 are reported as \>0.999."|Fisher Exact|Clopper and Pearson exact approach||Less Frequent Chemotherapy||||>0.999
72346666|NCT00931606|144215674|SUPERIORITY|||||||0.143|||||||Fisher Exact|Clopper and Pearson exact approach||Less Frequent Chemotherapy||||0.143
72346667|NCT00931606|144215674|SUPERIORITY|||||||0.519|||||||Fisher Exact|Clopper and Pearson exact approach||Less Frequent Chemotherapy||||0.519
72346668|NCT02170870|144215697|SUPERIORITY|||||||0.06|||||||ANOVA|||Mean GI symptom score during lipid infusion in controls vs diabetics adjusted for treatment status (ie, exendin or placebo)||||0.06
72346669|NCT02170870|144215697|SUPERIORITY|||||||0.0001|||||||ANOVA|||Mean GI symptom score during lipid infusion in controls vs functional dyspepsia adjusted for treatment status (ie, exendin or placebo)||||0.0001
72346670|NCT00125957|144215718|SUPERIORITY_OR_OTHER|||||||0.04|||||||Wilcoxon (Mann-Whitney)|||Null Hypothesis: There is no difference in the mean change MADRS score between Wellbutrin-Placebo and Placebo-Wellbutrin treatment groups||||.04
72346671|NCT00125957|144215719|SUPERIORITY_OR_OTHER|||||||0.09|||||||Wilcoxon (Mann-Whitney)|||Null Hypothesis: There is no difference in the median HAM-D score between Wellbutrin-Placebo and Placebo-Wellbutrin treatment groups||||0.09
72346672|NCT03828617|144215725|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio (GMR)|1.14|||||TWO_SIDED|95.0|0.95|1.37||||||Serotype 1: Geometric mean ratios (GMRs) (ratio of GMTs for 20vPnC Lot 1 to Lot 2) and 2-sided 95% confidence intervals (CIs).||1.37|0.95|
72346673|NCT03828617|144215725|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio (GMR)|1.01|||||TWO_SIDED|95.0|0.88|1.16||||||Serotype 3: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 2) and 2-sided 95% CIs.||1.16|0.88|
72346674|NCT03828617|144215725|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|0.96|||||TWO_SIDED|95.0|0.78|1.17||||||Serotype 4: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 2) and 2-sided 95% CIs.||1.17|0.78|
72346675|NCT03828617|144215725|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|0.93|||||TWO_SIDED|95.0|0.77|1.12||||||Serotype 5: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 2) and 2-sided 95% CIs.||1.12|0.77|
72346676|NCT03828617|144215725|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|1.24|||||TWO_SIDED|95.0|1.03|1.5||||||Serotype 6A: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 2) and 2-sided 95% CIs.||1.50|1.03|
72346677|NCT03828617|144215725|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|1.01|||||TWO_SIDED|95.0|0.85|1.21||||||Serotype 6B: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 2) and 2-sided 95% CIs.||1.21|0.85|
72346678|NCT03828617|144215725|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|0.98|||||TWO_SIDED|95.0|0.82|1.17||||||Serotype 7F: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 2) and 2-sided 95% CIs.||1.17|0.82|
72346679|NCT03828617|144215725|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|1.11|||||TWO_SIDED|95.0|0.93|1.33||||||Serotype 9V: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 2) and 2-sided 95% CIs.||1.33|0.93|
72346680|NCT03828617|144215725|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|1.07|||||TWO_SIDED|95.0|0.9|1.27||||||Serotype 14: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 2) and 2-sided 95% CIs.||1.27|0.90|
72346681|NCT03828617|144215725|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|0.88|||||TWO_SIDED|95.0|0.72|1.07||||||Serotype 18C: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 2) and 2-sided 95% CIs.||1.07|0.72|
72346682|NCT03828617|144215725|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|0.95|||||TWO_SIDED|95.0|0.81|1.12||||||Serotype 19A: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 2) and 2-sided 95% CIs.||1.12|0.81|
72346683|NCT03828617|144215725|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|0.99|||||TWO_SIDED|95.0|0.81|1.21||||||Serotype 19F: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 2) and 2-sided 95% CIs.||1.21|0.81|
72346684|NCT03828617|144215725|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|0.92|||||TWO_SIDED|95.0|0.72|1.16||||||Serotype 23F: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 2) and 2-sided 95% CIs.||1.16|0.72|
72346685|NCT03828617|144215725|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|1.19|||||TWO_SIDED|95.0|1.0|1.4||||||Serotype 8: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 2) and 2-sided 95% CIs.||1.40|1.00|
72346686|NCT03828617|144215725|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|1.11|||||TWO_SIDED|95.0|0.91|1.36||||||Serotype 10A: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 2) and 2-sided 95% CIs.||1.36|0.91|
72429042|NCT02404493|144368944|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.24||0.991|TWO_SIDED|95.0|-0.509|0.514||The significance level threshold level was 0.05.|ANCOVA|Change from baseline as response, baseline score as covariate and treatment as factor.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.514|-0.509|0.991
72346687|NCT03828617|144215725|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|1.29|||||TWO_SIDED|95.0|1.03|1.6||||||Serotype 11A: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 2) and 2-sided 95% CIs.||1.60|1.03|
72346688|NCT03828617|144215725|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|1.08|||||TWO_SIDED|95.0|0.88|1.33||||||Serotype 12F: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 2) and 2-sided 95% CIs.||1.33|0.88|
72346689|NCT03828617|144215725|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|1.16|||||TWO_SIDED|95.0|0.91|1.46||||||Serotype 15B: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 2) and 2-sided 95% CIs.||1.46|0.91|
72346690|NCT03828617|144215725|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|1.12|||||TWO_SIDED|95.0|0.87|1.43||||||Serotype 22F: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 2) and 2-sided 95% CIs.||1.43|0.87|
72346691|NCT03828617|144215725|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|1.04|||||TWO_SIDED|95.0|0.83|1.3||||||Serotype 33F: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 2) and 2-sided 95% CIs.||1.30|0.83|
72346692|NCT03828617|144215725|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|1.21|||||TWO_SIDED|95.0|1.01|1.46||||||Serotype 1: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 3) and 2-sided 95% CIs.||1.46|1.01|
72346693|NCT03828617|144215725|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|1.1|||||TWO_SIDED|95.0|0.96|1.26||||||Serotype 3: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 3) and 2-sided 95% CIs.||1.26|0.96|
72346694|NCT03828617|144215725|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|1.0|||||TWO_SIDED|95.0|0.82|1.22||||||Serotype 4: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 3) and 2-sided 95% CIs.||1.22|0.82|
72346695|NCT03828617|144215725|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|1.08|||||TWO_SIDED|95.0|0.89|1.31||||||Serotype 5: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 3) and 2-sided 95% CIs.||1.31|0.89|
72346696|NCT03828617|144215725|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|1.4|||||TWO_SIDED|95.0|1.16|1.69||||||Serotype 6A: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 3) and 2-sided 95% CIs.||1.69|1.16|
72346697|NCT03828617|144215725|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|1.13|||||TWO_SIDED|95.0|0.94|1.35||||||Serotype 6B: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 3) and 2-sided 95% CIs.||1.35|0.94|
72346698|NCT03828617|144215725|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|0.97|||||TWO_SIDED|95.0|0.81|1.16||||||Serotype 7F: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 3) and 2-sided 95% CIs.||1.16|0.81|
72346699|NCT03828617|144215725|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|1.04|||||TWO_SIDED|95.0|0.87|1.25||||||Serotype 9V: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 3) and 2-sided 95% CIs.||1.25|0.87|
72346700|NCT03828617|144215725|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|1.12|||||TWO_SIDED|95.0|0.94|1.33||||||Serotype 14: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 3) and 2-sided 95% CIs.||1.33|0.94|
72346701|NCT03828617|144215725|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|0.92|||||TWO_SIDED|95.0|0.75|1.13||||||Serotype 18C: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 3) and 2-sided 95% CIs.||1.13|0.75|
72346702|NCT03828617|144215725|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|1.02|||||TWO_SIDED|95.0|0.86|1.2||||||Serotype 19A: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 3) and 2-sided 95% CIs.||1.20|0.86|
72346703|NCT03828617|144215725|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|0.96|||||TWO_SIDED|95.0|0.78|1.17||||||Serotype 19F: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 3) and 2-sided 95% CIs.||1.17|0.78|
72346704|NCT03828617|144215725|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|0.99|||||TWO_SIDED|95.0|0.78|1.25||||||Serotype 23F: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 3) and 2-sided 95% CIs.||1.25|0.78|
72346705|NCT03828617|144215725|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|0.98|||||TWO_SIDED|95.0|0.83|1.16||||||Serotype 8: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 3) and 2-sided 95% CIs.||1.16|0.83|
72346706|NCT03828617|144215725|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|1.06|||||TWO_SIDED|95.0|0.87|1.3||||||Serotype 10A: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 3) and 2-sided 95% CIs.||1.30|0.87|
72429043|NCT02404493|144368945|SUPERIORITY_OR_OTHER||||||<|0.001||||||The significance level threshold level was 0.05.|One sample t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||<0.001
72346707|NCT03828617|144215725|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|0.99|||||TWO_SIDED|95.0|0.8|1.24||||||Serotype 11A: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 3) and 2-sided 95% CIs.||1.24|0.80|
72346708|NCT03828617|144215725|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|1.16|||||TWO_SIDED|95.0|0.94|1.42||||||Serotype 12F: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 3) and 2-sided 95% CIs.||1.42|0.94|
72346709|NCT03828617|144215725|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|1.05|||||TWO_SIDED|95.0|0.82|1.33||||||Serotype 15B: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 3) and 2-sided 95% CIs.||1.33|0.82|
72346710|NCT03828617|144215725|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|0.98|||||TWO_SIDED|95.0|0.77|1.26||||||Serotype 22F: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 3) and 2-sided 95% CIs.||1.26|0.77|
72346711|NCT03828617|144215725|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|1.03|||||TWO_SIDED|95.0|0.82|1.29||||||Serotype 33F: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 3) and 2-sided 95% CIs.||1.29|0.82|
72346712|NCT03828617|144215725|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|1.06|||||TWO_SIDED|95.0|0.89|1.28||||||Serotype 1: GMRs (ratio of GMTs for 20vPnC Lot 2 to Lot 3) and 2-sided 95% CIs.||1.28|0.89|
72346713|NCT03828617|144215725|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|1.09|||||TWO_SIDED|95.0|0.95|1.24||||||Serotype 3: GMRs (ratio of GMTs for 20vPnC Lot 2 to Lot 3) and 2-sided 95% CIs.||1.24|0.95|
72346714|NCT03828617|144215725|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|1.04|||||TWO_SIDED|95.0|0.85|1.27||||||Serotype 4: GMRs (ratio of GMTs for 20vPnC Lot 2 to Lot 3) and 2-sided 95% CIs.||1.27|0.85|
72346715|NCT03828617|144215725|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|1.16|||||TWO_SIDED|95.0|0.96|1.41||||||Serotype 5: GMRs (ratio of GMTs for 20vPnC Lot 2 to Lot 3) and 2-sided 95% CIs.||1.41|0.96|
72429044|NCT02404493|144368945|SUPERIORITY_OR_OTHER||||||<|0.001||||||The significance level threshold level was 0.05.|One sample t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||<0.001
72346716|NCT03828617|144215725|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|1.13|||||TWO_SIDED|95.0|0.93|1.36||||||Serotype 6A: GMRs (ratio of GMTs for 20vPnC Lot 2 to Lot 3) and 2-sided 95% CIs.||1.36|0.93|
72346717|NCT03828617|144215725|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|1.11|||||TWO_SIDED|95.0|0.93|1.33||||||Serotype 6B: GMRs (ratio of GMTs for 20vPnC Lot 2 to Lot 3) and 2-sided 95% CIs.||1.33|0.93|
72346718|NCT03828617|144215725|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|0.99|||||TWO_SIDED|95.0|0.83|1.19||||||Serotype 7F: GMRs (ratio of GMTs for 20vPnC Lot 2 to Lot 3) and 2-sided 95% CIs.||1.19|0.83|
72346719|NCT03828617|144215725|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|0.94|||||TWO_SIDED|95.0|0.78|1.12||||||Serotype 9V: GMRs (ratio of GMTs for 20vPnC Lot 2 to Lot 3) and 2-sided 95% CIs.||1.12|0.78|
72346720|NCT03828617|144215725|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|1.04|||||TWO_SIDED|95.0|0.88|1.24||||||Serotype 14: GMRs (ratio of GMTs for 20vPnC Lot 2 to Lot 3) and 2-sided 95% CIs.||1.24|0.88|
72346721|NCT03828617|144215725|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|1.05|||||TWO_SIDED|95.0|0.86|1.29||||||Serotype 18C: GMRs (ratio of GMTs for 20vPnC Lot 2 to Lot 3) and 2-sided 95% CIs.||1.29|0.86|
72346722|NCT03828617|144215725|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|1.07|||||TWO_SIDED|95.0|0.91|1.25||||||Serotype 19A: GMRs (ratio of GMTs for 20vPnC Lot 2 to Lot 3) and 2-sided 95% CIs.||1.25|0.91|
72346723|NCT03828617|144215725|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|0.96|||||TWO_SIDED|95.0|0.79|1.17||||||Serotype 19F: GMRs (ratio of GMTs for 20vPnC Lot 2 to Lot 3) and 2-sided 95% CIs.||1.17|0.79|
72346724|NCT03828617|144215725|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|1.08|||||TWO_SIDED|95.0|0.85|1.37||||||Serotype 23F: GMRs (ratio of GMTs for 20vPnC Lot 2 to Lot 3) and 2-sided 95% CIs.||1.37|0.85|
72346725|NCT03828617|144215725|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|0.83|||||TWO_SIDED|95.0|0.7|0.98||||||Serotype 8: GMRs (ratio of GMTs for 20vPnC Lot 2 to Lot 3) and 2-sided 95% CIs.||0.98|0.70|
72346726|NCT03828617|144215725|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|0.95|||||TWO_SIDED|95.0|0.78|1.17||||||Serotype 10A: GMRs (ratio of GMTs for 20vPnC Lot 2 to Lot 3) and 2-sided 95% CIs.||1.17|0.78|
72346727|NCT03828617|144215725|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|0.77|||||TWO_SIDED|95.0|0.62|0.96||||||Serotype 11A: GMRs (ratio of GMTs for 20vPnC Lot 2 to Lot 3) and 2-sided 95% CIs.||0.96|0.62|
72346728|NCT03828617|144215725|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|1.07|||||TWO_SIDED|95.0|0.87|1.31||||||Serotype 12F: GMRs (ratio of GMTs for 20vPnC Lot 2 to Lot 3) and 2-sided 95% CIs.||1.31|0.87|
72346729|NCT03828617|144215725|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|0.91|||||TWO_SIDED|95.0|0.71|1.15||||||Serotype 15B: GMRs (ratio of GMTs for 20vPnC Lot 2 to Lot 3) and 2-sided 95% CIs.||1.15|0.71|
72346730|NCT03828617|144215725|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|0.88|||||TWO_SIDED|95.0|0.69|1.12||||||Serotype 22F: GMRs (ratio of GMTs for 20vPnC Lot 2 to Lot 3) and 2-sided 95% CIs.||1.12|0.69|
72346731|NCT03828617|144215725|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|0.99|||||TWO_SIDED|95.0|0.79|1.24||||||Serotype 33F: GMRs (ratio of GMTs for 20vPnC Lot 2 to Lot 3) and 2-sided 95% CIs.||1.24|0.79|
72346732|NCT00265317|144215737|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.898||||0.3206|TWO_SIDED|80.0|0.575|1.404||Primary analysis was based on an unstratified 1-sided log rank test with alpha=0.1|Log Rank|||Sample size for randomized portion of study determined based on these assumptions: median PFS (erlotinib)=10 weeks, accrual time=12 months. With 6 months follow-up, study was powered to detect a difference in PFS of 5 weeks. 1-sided log rank test comparing the 2 treatment groups with 115 events of PD or death among a target sample size of 126 participants (63 per group) achieved 80% power at a 10% significance level to detect a 50% improvement in PFS from 10 to 15 weeks.||1.404|0.575|0.3206
72346733|NCT00265317|144215738|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.546||||0.6251|TWO_SIDED|95.0|0.267|8.954|||Cochran-Mantel-Haenszel|||95% confidence interval (CI) calculated based on f-distribution||8.954|0.267|0.6251
72346734|NCT00265317|144215739|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.921||||0.3732|TWO_SIDED|95.0|0.572|1.485||1-sided unstratified log-rank test|Log Rank|||||1.485|0.572|0.3732
72346735|NCT00265317|144215741|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.066||||0.6171|TWO_SIDED|95.0|0.705|1.612||p-value from 1-sided unstratified log-rank test|Log Rank|||||1.612|0.705|0.6171
72346736|NCT00265317|144215742|SUPERIORITY_OR_OTHER||Percentage|32.0|||||TWO_SIDED|95.0|19.7|44.3||||||Percentage of participants surviving at 1 year in the Sunitinib + Erlotinib Treatment Group, estimated using the Kaplan-Meier method||44.3|19.7|
72346737|NCT00265317|144215742|SUPERIORITY_OR_OTHER||Percentage|42.0|||||TWO_SIDED|95.0|30.1|54.2||||||Percentage of participants surviving at 1 year in the Erlotinib + Placebo Treatment Group, estimated using the Kaplan-Meier method||54.2|30.1|
72346738|NCT00265317|144215770|SUPERIORITY_OR_OTHER||Hazard Ratio, log|0.748||||0.2247|TWO_SIDED|95.0|0.351|1.591|||Log Rank|||Positive EGFR Expression||1.591|0.351|0.2247
72346739|NCT00265317|144215770|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.184||||0.6797|TWO_SIDED|95.0|0.581|2.414|||Log Rank|||Negative EGFR Expression||2.414|0.581|0.6797
72346740|NCT00265317|144215770|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.632||||0.1693|TWO_SIDED|95.0|0.245|1.627|||Log Rank|||Unmeasured EGFR Expression||1.627|0.245|0.1693
72346741|NCT00265317|144215772|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.864||||0.3223|TWO_SIDED|95.0|0.458|1.628|||Log Rank|||Positive EGFR Expression||1.628|0.458|0.3223
72346742|NCT00265317|144215772|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.946||||0.4608|TWO_SIDED|95.0|0.362|2.474|||Log Rank|||Negative EGFR Expression||2.474|0.362|0.4608
72346743|NCT00265317|144215772|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.632||||0.1693|TWO_SIDED|95.0|0.245|1.627|||Log Rank|||Unmeasured EGFR Expression||1.627|0.245|0.1693
72346744|NCT00265317|144215774|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.049||||0.5526|TWO_SIDED|95.0|0.542|2.031|||Log Rank|||No EGFR Gene Copy Number Increase||2.031|0.542|0.5526
72346745|NCT00265317|144215774|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.715||||0.1529|TWO_SIDED|95.0|0.38|1.344|||Log Rank|||Unmeasured EGFR Gene Copy Number Increase||1.344|0.380|0.1529
72346746|NCT00265317|144215776|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.078||||0.5839|TWO_SIDED|95.0|0.557|2.085|||Log Rank|||No EGFR Gene Amplification||2.085|0.557|0.5839
72429045|NCT02404493|144368945|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|0.19||0.334|TWO_SIDED|95.0|-0.214|0.6||The significance level threshold level was 0.05.|ANCOVA|Change from baseline as response, baseline score as covariate and treatment as factor.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.600|-0.214|0.334
72429046|NCT02404493|144368946|SUPERIORITY_OR_OTHER|||||||0.169||||||The significance level threshold level was 0.05.|One sample t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||0.169
72346747|NCT00265317|144215776|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.715||||0.1529|TWO_SIDED|95.0|0.38|1.344|||Log Rank|||Unmeasured EGFR Gene Amplification||1.344|0.380|0.1529
72346748|NCT00265317|144215778|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.16||||0.6324|TWO_SIDED|95.0|0.516|2.608|||Log Rank|||Wild Type EGFR Gene Mutation||2.608|0.516|0.6324
72346749|NCT00265317|144215778|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.813||||0.2413|TWO_SIDED|95.0|0.464|1.424|||Log Rank|||Indeterminate EGFR Gene Mutation||1.424|0.464|0.2413
72346750|NCT00265317|144215780|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.481||||0.2077|TWO_SIDED|95.0|0.079|2.91|||Log Rank|||Mutated KRAS Gene Mutation||2.910|0.079|0.2077
72346751|NCT00265317|144215780|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.162||||0.6439|TWO_SIDED|95.0|0.534|2.531|||Log Rank|||Wild Type KRAS Gene Mutation||2.531|0.534|0.6439
72346752|NCT00265317|144215780|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.825||||0.2664|TWO_SIDED|95.0|0.457|1.489|||Log Rank|||Indeterminate KRAS Gene Mutation||1.489|0.457|0.2664
72346753|NCT00265317|144215782|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.13||||0.7423|TWO_SIDED|95.0|0.541|2.36||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs1531289 Genotype: C/C||2.360|0.541|0.7423
72346754|NCT00265317|144215782|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.598||||0.157|TWO_SIDED|95.0|0.29|1.236||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs1531289 Genotype: C/T||1.236|0.290|0.1570
72346755|NCT00265317|144215782|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.794||||0.7954|TWO_SIDED|95.0|0.131|4.819||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs1531289 Genotype: T/T||4.819|0.131|0.7954
72346756|NCT00265317|144215782|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.833||||0.621|TWO_SIDED|95.0|0.401|1.732||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs2305945 Genotype: G/G||1.732|0.401|0.6210
72346757|NCT00265317|144215782|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.794||||0.5268|TWO_SIDED|95.0|0.385|1.64||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs2305945 Genotype: G/T||1.640|0.385|0.5268
72346758|NCT00265317|144215782|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.011||||0.9753|TWO_SIDED|95.0|0.504|2.027||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs1870377 Genotype: T/T||2.027|0.504|0.9753
72346759|NCT00265317|144215782|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.378||||0.0141|TWO_SIDED|95.0|0.168|0.85||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs1870377 Genotype: T/A||0.850|0.168|0.0141
72346760|NCT00265317|144215782|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.236||||0.5596|TWO_SIDED|95.0|0.139|35.9||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs1870377 Genotype: A/A||35.90|0.139|0.5596
72346761|NCT00265317|144215782|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.738||||0.2788|TWO_SIDED|95.0|0.422|1.288||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs2305948 Genotype: C/C||1.288|0.422|0.2788
72346762|NCT00265317|144215782|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.075||||0.8971|TWO_SIDED|95.0|0.352|3.286||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs2305948 Genotype: C/T||3.286|0.352|0.8971
72346763|NCT00265317|144215782|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.775||||0.6559|TWO_SIDED|95.0|0.251|2.388||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs7692791 Genotype: C/C||2.388|0.251|0.6559
72346764|NCT00265317|144215782|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.939||||0.8563|TWO_SIDED|95.0|0.466|1.889||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs7692791 Genotype: C/T||1.889|0.466|0.8563
72346765|NCT00265317|144215782|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.382||||0.668|TWO_SIDED|95.0|0.13|1.12||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs7692791 Genotype: T/T||1.120|0.130|0.668
72346766|NCT00265317|144215782|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.8||||0.3681|TWO_SIDED|95.0|0.488|1.309||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs35636987 Genotype: C/C||1.309|0.488|0.3681
72346767|NCT00265317|144215782|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.86||||0.752|TWO_SIDED|95.0|0.331|2.237||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs7667298 Genotype: C/C||2.237|0.331|0.7520
72346768|NCT00265317|144215782|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.551||||0.0833|TWO_SIDED|95.0|0.276|1.098||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs7667298 Genotype: C/T||1.098|0.276|0.0833
72346769|NCT00265317|144215782|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.564||||0.4772|TWO_SIDED|95.0|0.444|5.506||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs7667298 Genotype: T/T||5.506|0.444|0.4772
72346770|NCT00265317|144215782|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.034||||0.9235|TWO_SIDED|95.0|0.522|2.048||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs41408948 Genotype: G/G||2.048|0.522|0.9235
72346771|NCT00265317|144215782|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.501||||0.0845|TWO_SIDED|95.0|0.223|1.126||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs41408948 Genotype: G/A||1.126|0.223|0.0845
72346772|NCT00265317|144215782|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.724||||0.5493|TWO_SIDED|95.0|0.284|10.47||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs41408948 Genotype: A/A||10.47|0.284|0.5493
72346773|NCT00265317|144215782|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.4||||0.521|TWO_SIDED|95.0|0.492|3.987||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs2071559 Genotype: G/G||3.987|0.492|0.5210
72346774|NCT00265317|144215782|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.538||||0.0854|TWO_SIDED|95.0|0.261|1.108||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs2071559 Genotype: G/A||1.108|0.261|0.0854
72346775|NCT00265317|144215782|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.953||||0.9198|TWO_SIDED|95.0|0.365|2.489||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs2071559 Genotype: A/A||2.489|0.365|0.9198
72346776|NCT00265317|144215783|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.977||||0.9486|TWO_SIDED|95.0|0.473|2.014||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs1531289 Genotype: C/C||2.014|0.473|0.9486
72346777|NCT00265317|144215783|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.961||||0.9084|TWO_SIDED|95.0|0.487|1.897||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs1531289 Genotype: C/T||1.897|0.487|0.9084
72346778|NCT00265317|144215783|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.876||||0.2009|TWO_SIDED|95.0|0.534|15.48||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs1531289 Genotype: T/T||15.48|0.534|0.2009
72429047|NCT02404493|144368946|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.24||0.317|TWO_SIDED|95.0|-0.778|0.278||The significance level threshold level was 0.05.|ANCOVA|Change from baseline as response, baseline score as covariate and treatment as factor.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.278|-0.778|0.317
72429048|NCT02404493|144368947|SUPERIORITY_OR_OTHER||||||<|0.001||||||The significance level threshold level was 0.05.|One sample t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||<0.001
72429049|NCT02404493|144368947|SUPERIORITY_OR_OTHER|||||||0.182||||||The significance level threshold level was 0.05.|One sample t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||0.182
72429050|NCT02404493|144368947|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|0.19||0.027|TWO_SIDED|95.0|-0.931|-0.069||The significance level threshold level was 0.05.|ANCOVA|Change from baseline as response, baseline score as covariate and treatment as factor.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||-0.069|-0.931|0.027
72429051|NCT02404493|144368948|SUPERIORITY_OR_OTHER||||||<|0.001||||||The significance level threshold level was 0.05.|One sample t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||<0.001
72346779|NCT00265317|144215783|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.098||||0.7863|TWO_SIDED|95.0|0.554|2.175||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs2305845 Genotype: G/G||2.175|0.554|0.7863
72346780|NCT00265317|144215783|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.243||||0.5267|TWO_SIDED|95.0|0.633|2.442||2-sided unstratified log-rank test|Log Rank|||Locus: VEFR2/rs2305945 Genotype: G/T||2.442|0.633|0.5267
72346781|NCT00265317|144215783|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.55||||0.624|TWO_SIDED|95.0|0.049|6.208||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs2305945 Genotype: T/T||6.208|0.049|0.6240
72346782|NCT00265317|144215783|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.254||||0.4882|TWO_SIDED|95.0|0.66|2.384||2-sided unstratified log-rank test|Log Rank|||Locus: VEFR/rs1870377 Genotype: T/T||2.384|0.660|0.4882
72346783|NCT00265317|144215783|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.587||||0.1307|TWO_SIDED|95.0|0.29|1.189||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs1870377 Genotype: T/A||1.189|0.290|0.1307
72346784|NCT00265317|144215783|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.236||||0.5596|TWO_SIDED|95.0|0.139|35.9||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs1870377 Genotype: A/A||35.90|0.139|0.5596
72346785|NCT00265317|144215783|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.073||||0.7966|TWO_SIDED|95.0|0.628|1.833||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs2305948 Genotype: C/C||1.833|0.628|0.7966
72346786|NCT00265317|144215783|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.954||||0.9224|TWO_SIDED|95.0|0.366|2.484||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs2305948 Genotype: C/T||2.484|0.366|0.9224
72346787|NCT00265317|144215783|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.047||||0.9317|TWO_SIDED|95.0|0.363|3.025||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs7692791 Genotype: C/C||3.025|0.363|0.9317
72346788|NCT00265317|144215783|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.057||||0.8696|TWO_SIDED|95.0|0.546|2.044||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs7692791 Genotype: C/T||2.044|0.546|0.8696
72346789|NCT00265317|144215783|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.075||||0.8694|TWO_SIDED|95.0|0.453|2.554||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs7692791 Genotype: T/T||2.554|0.453|0.8694
72346790|NCT00265317|144215783|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.039||||0.8708|TWO_SIDED|95.0|0.654|1.652||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs3563987 Genotype: C/C||1.652|0.654|0.8708
72346791|NCT00265317|144215783|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.157||||0.7667|TWO_SIDED|95.0|0.442|3.026||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs7667298 Genotype: C/C||3.026|0.442|0.7667
72346792|NCT00265317|144215783|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.755||||0.3822|TWO_SIDED|95.0|0.401|1.422||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs7667298 Genotype: C/T||1.422|0.401|0.3822
72346793|NCT00265317|144215783|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.419||||0.5089|TWO_SIDED|95.0|0.498|4.04||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs7667298 Genotype: T/T||4.040|0.498|0.5089
72346794|NCT00265317|144215783|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.326||||0.3944|TWO_SIDED|95.0|0.691|2.544||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs41408948 Genotype: G/G||2.544|0.691|0.3944
72346795|NCT00265317|144215783|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.692||||0.3103|TWO_SIDED|95.0|0.339|1.416||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs41408948 Genotype: G/A||1.416|0.339|0.3103
72346796|NCT00265317|144215783|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.857||||0.8942|TWO_SIDED|95.0|0.089|8.294||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs41408948 Genotype: A/A||8.294|0.089|0.8942
72346797|NCT00265317|144215783|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.24||||0.665|TWO_SIDED|95.0|0.466|3.304||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs2071559 Genotype: G/G||3.304|0.466|0.6650
72346798|NCT00265317|144215783|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.779||||0.4415|TWO_SIDED|95.0|0.412|1.475||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs2071559 Genotype: G/A||1.475|0.412|0.4415
72346799|NCT00265317|144215783|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.458||||0.4682|TWO_SIDED|95.0|0.523|4.06||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs2071559 Genotype: A/A||4.060|0.523|0.4682
72346800|NCT00265317|144215785|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.289||||0.7301|TWO_SIDED|95.0|0.304|5.47||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs2304060 Genotype: C/C||5.470|0.304|0.7301
72346801|NCT00265317|144215785|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.788||||0.5013|TWO_SIDED|95.0|0.39|1.592||2-sided unstratified log-rank test|Log Rank|||PDGFRB/rs2304060 C/A||1.592|0.390|0.5013
72346802|NCT00265317|144215785|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.686||||0.368|TWO_SIDED|95.0|0.298|1.578||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs2304060 Genotype: A/A||1.578|0.298|0.3680
72346803|NCT00265317|144215785|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.738||||0.3804|TWO_SIDED|95.0|0.371|1.467||2-sided, unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs17656204 Genotype: C/C||1.467|0.371|0.3804
72346804|NCT00265317|144215785|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.57||||0.1507|TWO_SIDED|95.0|0.261|1.247||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs17656204 Genotype: C/T||1.247|0.261|0.1507
72346805|NCT00265317|144215785|SUPERIORITY_OR_OTHER|||||||0.0772||||||2-sided unstratified log-rank test|Log Rank|||Locus PDGFRB/rs17656204 Genotype: T/T||||0.0772
72346806|NCT00265317|144215785|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.66||||0.2149|TWO_SIDED|95.0|0.339|1.284||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs2304061 Genotype: G/G||1.284|0.339|0.2149
72346807|NCT00265317|144215785|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.026||||0.9491|TWO_SIDED|95.0|0.466|2.26||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/RS2304061 Genotype: G/A||2.260|0.466|0.9491
72346808|NCT00265317|144215785|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.917||||0.8114|TWO_SIDED|95.0|0.447|1.881||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs1077724 Genotype: A/A||1.881|0.447|0.8114
72346809|NCT00265317|144215785|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.577||||0.1379|TWO_SIDED|95.0|0.273|1.221||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs1077724 Genotype: A/T||1.221|0.273|0.1379
72346810|NCT00265317|144215785|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.859||||0.5341|TWO_SIDED|95.0|0.256|13.51||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs1077724 Genotype: T/T||13.51|0.256|0.5341
72346811|NCT00265317|144215785|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.932||||0.8564|TWO_SIDED|95.0|0.431|2.014||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs919751 Genotype: A/A||2.014|0.431|0.8564
72346812|NCT00265317|144215785|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.797||||0.5766|TWO_SIDED|95.0|0.355|1.788||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs919751 Genotype: A/G||1.788|0.355|0.5766
72346813|NCT00265317|144215785|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.467||||0.2043|TWO_SIDED|95.0|0.14|1.557||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs919751 Genotype: G/G||1.557|0.140|0.2043
72346814|NCT00265317|144215785|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.531||||0.1626|TWO_SIDED|95.0|0.214|1.317||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs2304058 Genotype: G/G||1.317|0.214|0.1626
72346815|NCT00265317|144215785|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.986||||0.968|TWO_SIDED|95.0|0.484|2.006||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs2304058 Genotype: G/C||2.006|0.484|0.9680
72346816|NCT00265317|144215785|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.573||||0.3587|TWO_SIDED|95.0|0.171|1.92||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs2304058 Genotype: C/C||1.920|0.171|0.3587
72346817|NCT00265317|144215785|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.742||||0.4635|TWO_SIDED|95.0|0.331|1.662||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs1864972 Genotype: G/G||1.662|0.331|0.4635
72346818|NCT00265317|144215785|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.992||||0.9834|TWO_SIDED|95.0|0.476|2.069||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs1864972 Genotype: G/A||2.069|0.476|0.9834
72346819|NCT00265317|144215785|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.353||||0.1764|TWO_SIDED|95.0|0.072|1.725||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs1864972 Genotype: A/A||1.725|0.072|0.1764
72346820|NCT00265317|144215785|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.715||||0.2018|TWO_SIDED|95.0|0.422|1.209||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs3733678 Genotype: G/G||1.209|0.422|0.2018
72346821|NCT00265317|144215785|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.85||||0.4592|TWO_SIDED|95.0|0.354|9.673||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs3733678 Genotype: G/A||9.673|0.354|0.4592
72346822|NCT00265317|144215785|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.665||||0.1593|TWO_SIDED|95.0|0.373|1.184||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs246396 Genotype: T/T||1.184|0.373|0.1593
72346823|NCT00265317|144215785|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.327||||0.5897|TWO_SIDED|95.0|0.469|3.755||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs246396 Genotype: T/C||3.755|0.469|0.5897
72346824|NCT00265317|144215785|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.8||||0.3681|TWO_SIDED|95.0|0.488|1.309||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs34586048 Genotype: C/C||1.309|0.488|0.3681
72346825|NCT00265317|144215785|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.752||||0.3235|TWO_SIDED|95.0|0.423|1.336||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs11740355 Genotype: T/T||1.336|0.423|0.3235
72346826|NCT00265317|144215785|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.845||||0.7463|TWO_SIDED|95.0|0.303|2.355||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs11740355 Genotype: T/G||2.355|0.303|0.7463
72346827|NCT00265317|144215785|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.724||||0.4179|TWO_SIDED|95.0|0.33|1.593||2-sided unstratified log-rank test|Log Rank|||Locus: rs740751 Genotype: C/C||1.593|0.330|0.4179
72346828|NCT00265317|144215785|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.973||||0.9423|TWO_SIDED|95.0|0.462|2.05||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs740751 Genotype: C/T||2.050|0.462|0.9423
72346829|NCT00265317|144215785|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.353||||0.1764|TWO_SIDED|95.0|0.072|1.725||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs7407451 Genotype: T/T||1.725|0.072|0.1764
72346830|NCT00265317|144215785|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.549||||0.2352|TWO_SIDED|95.0|0.201|1.501||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs4705415 Genotype: G/G||1.501|0.201|0.2352
72346831|NCT00265317|144215785|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.986||||0.9674|TWO_SIDED|95.0|0.485|2.003||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs4705415 Genotype: G/A||2.003|0.485|0.9674
72346832|NCT00265317|144215785|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.629||||0.3524|TWO_SIDED|95.0|0.235|1.686||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs4705415 Genotype: A/A||1.686|0.235|0.3524
72346833|NCT00265317|144215785|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.809||||0.6652|TWO_SIDED|95.0|0.308|2.124||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs3776075 Genotype: T/T||2.124|0.308|0.6652
72346834|NCT00265317|144215785|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.839||||0.5931|TWO_SIDED|95.0|0.436|1.618||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs3776075 Genotype: T/G||1.618|0.436|0.5931
72346835|NCT00265317|144215785|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.475||||0.2625|TWO_SIDED|95.0|0.125|1.813||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs3776075 Genotype: G/G||1.813|0.125|0.2625
72346836|NCT00265317|144215785|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.704||||0.2168|TWO_SIDED|95.0|0.4|1.239||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs17708574 Genotype: G/G||1.239|0.400|0.2168
72346837|NCT00265317|144215785|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.987||||0.9802|TWO_SIDED|95.0|0.353|2.759||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs17708574 Genotype: G/A||2.759|0.353|0.9802
72346838|NCT00265317|144215785|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.652||||0.1145|TWO_SIDED|95.0|0.378|1.122||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs10063714 Genotype: T/T||1.122|0.378|0.1145
72346839|NCT00265317|144215785|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.192||||0.7725|TWO_SIDED|95.0|0.36|3.946||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs10063714 Genotype: T/A||3.946|0.360|0.7725
72346840|NCT00265317|144215785|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.687||||0.3286|TWO_SIDED|95.0|0.321|1.473||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs3776081 Genotype: A/A||1.473|0.321|0.3286
72346841|NCT00265317|144215785|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.976||||0.948|TWO_SIDED|95.0|0.47|2.028||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs3776081 Genotype: A/G||2.028|0.470|0.9480
72346842|NCT00265317|144215785|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.531||||0.3844|TWO_SIDED|95.0|0.125|2.282||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs3776081 Genotype: G/G||2.282|0.125|0.3844
72346843|NCT00265317|144215785|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.662||||0.1373|TWO_SIDED|95.0|0.381|1.153||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs2007637 Genotype: G/G||1.153|0.381|0.1373
72346844|NCT00265317|144215785|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.114||||0.8586|TWO_SIDED|95.0|0.339|3.667||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs2007637 Genotype: G/A||3.667|0.339|0.8586
72346845|NCT00265317|144215785|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.935||||0.8478|TWO_SIDED|95.0|0.47|1.861||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs2302273 Genotype: G/G||1.861|0.470|0.8478
72346846|NCT00265317|144215785|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.634||||0.2445|TWO_SIDED|95.0|0.287|1.401||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs2302273 Genotype: G/A||1.401|0.287|0.2445
72429052|NCT02404493|144368948|SUPERIORITY_OR_OTHER|||||||0.08||||||The significance level threshold level was 0.05.|One sample t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||0.080
72346847|NCT00265317|144215785|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.155||||0.9191|TWO_SIDED|95.0|0.072|18.59||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs2302273 Genotype: A/A||18.59|0.072|0.9191
72346848|NCT00265317|144215786|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.121||||0.8563|TWO_SIDED|95.0|0.326|3.847||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs2304060 Genotype: C/C||3.847|0.326|0.8563
72346849|NCT00265317|144215786|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.111||||0.7375|TWO_SIDED|95.0|0.599|2.064||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs2304060 Genotype: C/A||2.064|0.599|0.7375
72346850|NCT00265317|144215786|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.897||||0.8066|TWO_SIDED|95.0|0.375|2.147||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs234060 Genotype: A/A||2.147|0.375|0.8066
72346851|NCT00265317|144215786|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.875||||0.6945|TWO_SIDED|95.0|0.449|1.708||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs17656204 Genotype: C/C||1.708|0.449|0.6945
72346852|NCT00265317|144215786|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.067||||0.8536|TWO_SIDED|95.0|0.536|2.122||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs17656204 Genotype: C/T||2.122|0.536|0.8536
72346853|NCT00265317|144215786|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.732||||0.3657|TWO_SIDED|95.0|0.283|26.42||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs17656204 Genotype: T/T||26.42|0.283|0.3657
72346854|NCT00265317|144215786|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.793||||0.4657|TWO_SIDED|95.0|0.424|1.483||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs2304061 Genotype: G/G||1.483|0.424|0.4657
72346855|NCT00265317|144215786|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.364||||0.4168|TWO_SIDED|95.0|0.641|2.9||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs2304061 Genotype: G/A||2.900|0.641|0.4168
72346856|NCT00265317|144215786|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.908||||0.7836|TWO_SIDED|95.0|0.456|1.809||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs1077724 Genotype: A/A||1.809|0.456|0.7836
72346857|NCT00265317|144215786|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.938||||0.8531|TWO_SIDED|95.0|0.472|1.863||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs1077724 Genotype: A/T||1.863|0.472|0.8531
72346858|NCT00265317|144215786|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.32||||0.3272|TWO_SIDED|95.0|0.412|13.07||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs1077724 Genotype: T/T||13.07|0.412|0.3272
72346859|NCT00265317|144215786|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.984||||0.963|TWO_SIDED|95.0|0.491|1.972||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs919751 Genotype: A/A||1.972|0.491|0.9630
72346860|NCT00265317|144215786|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.227||||0.6003|TWO_SIDED|95.0|0.567|2.656||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs919751 Genotype: A/G||2.656|0.567|0.6003
72346861|NCT00265317|144215786|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.769||||0.6703|TWO_SIDED|95.0|0.229|2.58||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs919751 Genotype: G/G||2.580|0.229|0.6703
72346862|NCT00265317|144215786|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.106||||0.81|TWO_SIDED|95.0|0.485|2.525||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs2304058 Genotype: G/G||2.525|0.485|0.8100
72346863|NCT00265317|144215786|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.076||||0.8335|TWO_SIDED|95.0|0.541|2.141||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs2304058 Genotype: G/C||2.141|0.541|0.8335
72346864|NCT00265317|144215786|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.758||||0.598|TWO_SIDED|95.0|0.268|2.141||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs2304058 Genotype: C/C||2.141|0.268|0.5980
72346865|NCT00265317|144215786|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.035||||0.9287|TWO_SIDED|95.0|0.487|2.199||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs1864972 Genotype: G/G||2.199|0.487|0.9287
72346866|NCT00265317|144215786|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.053||||0.8842|TWO_SIDED|95.0|0.526|2.106||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs1864972 Genotype: G/A||2.106|0.526|0.8842
72346867|NCT00265317|144215786|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.129||||0.8501|TWO_SIDED|95.0|0.316|4.028||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs1864972 Genotype: A/A||4.028|0.316|0.8501
72346868|NCT00265317|144215786|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.229||||0.4118|TWO_SIDED|95.0|0.749|2.017||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs3733678 Genotype: G/G||2.017|0.749|0.4118
72346869|NCT00265317|144215786|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.286||||0.1299|TWO_SIDED|95.0|0.051|1.596||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs3733678 Genotype: G/A||1.596|0.051|0.1299
72346870|NCT00265317|144215786|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.692||||0.1859|TWO_SIDED|95.0|0.399|1.2||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs246396 Genotype: T/T||1.200|0.399|0.1859
72346871|NCT00265317|144215786|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|3.672||||0.0091|TWO_SIDED|95.0|1.291|10.44||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs246396 Genotype: T/C||10.44|1.291|0.0091
72346872|NCT00265317|144215786|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.039||||0.8708|TWO_SIDED|95.0|0.654|1.652||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs34586048 Genotype: C/C||1.652|0.654|0.8708
72346873|NCT00265317|144215786|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.996||||0.9888|TWO_SIDED|95.0|0.59|1.681||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs11740355 Genotype: T/T||1.681|0.590|0.9888
72346874|NCT00265317|144215786|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.02||||0.9702|TWO_SIDED|95.0|0.36|2.891||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs11740355 Genotype: T/G||2.891|0.360|0.9702
72346875|NCT00265317|144215786|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.973||||0.9419|TWO_SIDED|95.0|0.466|2.032||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs740751 Genotype: C/C||2.032|0.466|0.9419
72346876|NCT00265317|144215786|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.112||||0.7677|TWO_SIDED|95.0|0.549|2.252||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs740751 Genotype: C/T||2.252|0.549|0.7677
72346877|NCT00265317|144215786|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.129||||0.8501|TWO_SIDED|95.0|0.316|4.028||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs740751 Genotype: T/T||4.028|0.316|0.8501
72346878|NCT00265317|144215786|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.758||||0.5233|TWO_SIDED|95.0|0.322|1.782||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs4705415 Genotype: G/G||1.782|0.322|0.5233
72346879|NCT00265317|144215786|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.123||||0.75|TWO_SIDED|95.0|0.549|2.297||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs4705415 Genotype: G/A||2.297|0.549|0.7500
72346880|NCT00265317|144215786|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.232||||0.6614|TWO_SIDED|95.0|0.483|3.142||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs4705415 Genotype: A/A||3.142|0.483|0.6614
72346881|NCT00265317|144215786|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.779||||0.2552|TWO_SIDED|95.0|0.652|4.855||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs3776075 Genotype: T/T||4.855|0.652|0.2552
72346882|NCT00265317|144215786|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.088||||0.7931|TWO_SIDED|95.0|0.577|2.052||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs3776075 Genotype: T/G||2.052|0.577|0.7931
72346883|NCT00265317|144215786|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.449||||0.1365|TWO_SIDED|95.0|0.152|1.331||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs3776075 Genotype: G/G||1.331|0.152|0.1365
72346884|NCT00265317|144215786|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.854||||0.5544|TWO_SIDED|95.0|0.504|1.447||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs17708574 Genotype: G/G||1.447|0.504|0.5544
72346885|NCT00265317|144215786|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.721||||0.3132|TWO_SIDED|95.0|0.59|5.021||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs17708574 Genotype: G/A||5.021|0.590|0.3132
72346886|NCT00265317|144215786|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.263||||0.3698|TWO_SIDED|95.0|0.755|2.113||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs10063714 Genotype: T/T||2.113|0.755|0.3698
72346887|NCT00265317|144215786|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.411||||0.1495|TWO_SIDED|95.0|0.119|1.423||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs10063714 Genotype: T/A||1.423|0.119|0.1495
72346888|NCT00265317|144215786|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.613||||0.1911|TWO_SIDED|95.0|0.781|3.332||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs3776081 Genotype: A/A||3.332|0.781|0.1911
72346889|NCT00265317|144215786|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.793||||0.5259|TWO_SIDED|95.0|0.384|1.636||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs3776081 Genotype: A/G||1.636|0.384|0.5259
72346890|NCT00265317|144215786|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.331||||0.0996|TWO_SIDED|95.0|0.082|1.339||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs3776081 Genotype: G/G||1.339|0.082|0.0996
72346891|NCT00265317|144215786|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.752||||0.2755|TWO_SIDED|95.0|0.45|1.259||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs2007637 Genotype: G/G||1.259|0.450|0.2755
72346892|NCT00265317|144215786|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|4.85||||0.012|TWO_SIDED|95.0|1.253|18.78||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs2007637 Genotype: G/A||18.78|1.253|0.0120
72346893|NCT00265317|144215786|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.274||||0.4663|TWO_SIDED|95.0|0.661|2.457||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs2302273 Genotype: G/G||2.457|0.661|0.4663
72346894|NCT00265317|144215786|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.867||||0.7097|TWO_SIDED|95.0|0.406|1.848||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs2302273 Genotype: G/A||1.848|0.406|0.7097
72346895|NCT00265317|144215786|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.607||||0.534|TWO_SIDED|95.0|0.117|3.158||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs2302273 Genotype: A/A||3.158|0.117|0.5340
72346896|NCT00265317|144215789|SUPERIORITY_OR_OTHER|||||||0.2702|||||||Wilcoxon Rank Sum Test|||VEGF-C Ratio to Baseline for Cycle 2, Day 1||||0.2702
72346897|NCT00265317|144215789|SUPERIORITY_OR_OTHER|||||||0.7354||95.0|||||Wilcoxon Rank Sum Test|||VEGF-C ratio to Baseline for Cycle 3, Day 1||||0.7354
72346898|NCT00265317|144215791|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Rank Sum Test|||VEGFR-2 Ratio to Baseline for Cycle 2, Day 1||||<0.0001
72346899|NCT00265317|144215791|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon Rank Sum Test|||VEGFR-2 Ratio to Baseline for Cycle 3, Day 1||||<0.0001
72346900|NCT00265317|144215792|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.553||||0.1667|TWO_SIDED|95.0|0.159|1.921||1-sided unstratified log-rank test|Log Rank|||High CSF-1R expression||1.921|0.159|0.1667
72346901|NCT00265317|144215792|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.451||||0.7688|TWO_SIDED|95.0|0.534|3.944||1-sided unstratified log-rank test|Log Rank|||Low CSF-1R expression||3.944|0.534|0.7688
72346902|NCT00265317|144215792|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.89||||0.3498|TWO_SIDED|95.0|0.503|1.574||1-sided unstratified log-rank test|Log Rank|||Indeterminate CSF-1R expression||1.574|0.503|0.3498
72346903|NCT00265317|144215792|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.687||||0.9497|TWO_SIDED|95.0|0.79|9.143||1-sided unstratified log-rank test|Log Rank|||High PDGFRalpha expression||9.143|0.790|0.9497
72346904|NCT00265317|144215792|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.386||||0.0401|TWO_SIDED|95.0|0.127|1.173||1-sided unstratified log-rank test|Log Rank|||Low PDGFRalpha expression||1.173|0.127|0.0401
72346905|NCT00265317|144215792|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.862||||0.3128|TWO_SIDED|95.0|0.487|1.524||1-sided unstratified log-rank test|Log Rank|||Indeterminate PDGFRalpha expression||1.524|0.487|0.3128
72346906|NCT00265317|144215792|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.823||||0.365|TWO_SIDED|95.0|0.273|2.488||1-sided unstratified log-rank test|Log Rank|||High PDGFRbeta expression||2.488|0.273|0.3650
72346907|NCT00265317|144215792|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.192||||0.6105|TWO_SIDED|95.0|0.408|3.48||1-sided unstratified log-rank test|Log Rank|||Low PDGFRbeta expression||3.480|0.408|0.6105
72346908|NCT00265317|144215792|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.856||||0.3027|TWO_SIDED|95.0|0.488|1.502||1-sided unstratified log-rank test|Log Rank|||Indeterminate PDGFRbeta expression||1.502|0.488|0.3027
72346909|NCT00265317|144215792|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.914||||0.4436|TWO_SIDED|95.0|0.262|3.184||1-sided unstratified log-rank test|Log Rank|||High VEGF expression||3.184|0.262|0.4436
72346910|NCT00265317|144215792|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.953||||0.4582|TWO_SIDED|95.0|0.296|3.062||1-sided unstratified log-rank test|Log Rank|||Low VEGF expression||3.062|0.296|0.4582
72346911|NCT00265317|144215792|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.911||||0.372|TWO_SIDED|95.0|0.536|1.548||1-sided unstratified log-rank test|Log Rank|||Indeterminate VEGF expression||1.548|0.536|0.3720
72346912|NCT00265317|144215792|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.09||||0.5586|TWO_SIDED|95.0|0.35|3.397||1-sided unstratified log-rank test|Log Rank|||High VEGF-C expression||3.397|0.350|0.5586
72346913|NCT00265317|144215792|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.842||||0.3652|TWO_SIDED|95.0|0.313|2.266||1-sided unstratified log-rank test|Log Rank|||Low VEGF-C expression||2.266|0.313|0.3652
72346914|NCT00265317|144215792|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.875||||0.3301|TWO_SIDED|95.0|0.493|1.554||1-sided unstratified log-rank test|Log Rank|||Indeterminate VEGF-C expression||1.554|0.493|0.3301
72346915|NCT00265317|144215792|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.097||||0.5605|TWO_SIDED|95.0|0.331|3.636||1-sided unstratified log-rank test|Log Rank|||High VEGFR1 expression||3.636|0.331|0.5605
72346916|NCT00265317|144215792|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.599||||0.2132|TWO_SIDED|95.0|0.16|2.236||1-sided unstratified log-rank test|Log Rank|||Low VEGFR1 expression||2.236|0.160|0.2132
72346917|NCT00265317|144215792|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.902||||0.3605|TWO_SIDED|95.0|0.53|1.537||1-sided unstratified log-rank test|Log Rank|||Indeterminate VEGFR1 expression||1.537|0.530|0.3605
72346918|NCT00265317|144215792|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.921||||0.4438|TWO_SIDED|95.0|0.304|2.784||1-sided unstratified log-rank test|Log Rank|||High VEGFR2 expression||2.784|0.304|0.4438
72346919|NCT00265317|144215792|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.122||||0.5699|TWO_SIDED|95.0|0.403|3.125||1-sided unstratified log-rank test|Log Rank|||Low VEGFR2 expression||3.125|0.403|0.5699
72346920|NCT00265317|144215792|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.864||||0.3147|TWO_SIDED|95.0|0.489|1.528||1-sided unstratified log-rank test|Log Rank|||Indeterminate VEGFR2 expression||1.528|0.489|0.3147
72346921|NCT00265317|144215792|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.002||||0.5015|TWO_SIDED|95.0|0.281|3.581||1-sided unstratified log-rank test|Log Rank|||High VEGFR3 expression||3.581|0.281|0.5015
72346922|NCT00265317|144215792|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.005||||0.4887|TWO_SIDED|95.0|0.334|3.025||1-sided unstratified log-rank test|Log Rank|||Low VEGFR3 expression||3.025|0.334|0.4887
72346923|NCT00265317|144215792|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.818||||0.2432|TWO_SIDED|95.0|0.473|1.414||1-sided unstratified log-rank test|Log Rank|||Indeterminate VEGFR3 expression||1.414|0.473|0.2432
72346924|NCT00265317|144215792|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.446||||0.2321|TWO_SIDED|95.0|0.048|4.101||1-sided unstratified log-rank test|Log Rank|||Detected FGF expression||4.101|0.048|0.2321
72346925|NCT00265317|144215792|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.316||||0.7143|TWO_SIDED|95.0|0.526|3.292||1-sided unstratified log-rank test|Log Rank|||No detected FGF expression||3.292|0.526|0.7143
72346926|NCT00265317|144215792|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.844||||0.2812|TWO_SIDED|95.0|0.486|1.465||1-sided unstratified log-rank test|Log Rank|||Indeterminate FGF expression||1.465|0.486|0.2812
72346927|NCT00265317|144215792|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.406||||0.6504|TWO_SIDED|95.0|0.248|7.96||1-sided unstratified log-rank test|Log Rank|||Detected FLT3 expression||7.960|0.248|0.6504
72346928|NCT00265317|144215792|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.838||||0.3266|TWO_SIDED|95.0|0.375|1.876||1-sided unstratified log-rank test|Log Rank|||No detected FLT3 expression||1.876|0.375|0.3266
72346929|NCT00265317|144215792|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.896||||0.3597|TWO_SIDED|95.0|0.502|1.598||1-sided unstratified log-rank test|Log Rank|||Indeterminate FLT3 expression||1.598|0.502|0.3597
72346930|NCT00265317|144215792|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.342||||0.6907|TWO_SIDED|95.0|0.419|4.297||1-sided unstratified log-rank test|Log Rank|||Detected KIT expression||4.297|0.419|0.6907
72346931|NCT00265317|144215792|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.677||||0.199|TWO_SIDED|95.0|0.265|1.731||1-sided unstratified log-rank test|Log Rank|||Participants with no detected KIT expression||1.731|0.265|0.1990
72346932|NCT00265317|144215792|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.896||||0.3597|TWO_SIDED|95.0|0.502|1.598||1-sided unstratified log-rank test|Log Rank|||Indeterminate KIT expression||1.598|0.502|0.3597
72346933|NCT00265317|144215792|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.693||||0.3757|TWO_SIDED|95.0|0.071|6.765||1-sided unstratified log-rank test|Log Rank|||Detected RET expression||6.765|0.071|0.3757
72346934|NCT00265317|144215792|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.874||||0.3723|TWO_SIDED|95.0|0.358|2.13||1-sided unstratified log-rank test|Log Rank|||No detected RET expression||2.130|0.358|0.3723
72346935|NCT00265317|144215792|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.874||||0.3263|TWO_SIDED|95.0|0.501|1.523||1-sided unstratified log-rank test|Log Rank|||Indeterminate RET expression||1.523|0.501|0.3263
72346936|NCT00265317|144215793|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Rank Sum Test|||VEGFR-3 Ratio to Baseline for Cycle 2, Day 1||||<0.0001
72346937|NCT00265317|144215793|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon Rank Sum Test|||VEGFR-3 Ratio to Baseline for Cycle 3, Day 1||||<0.0001
72346938|NCT00265317|144215795|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Rank Sum Test|||sKIT Ratio to Baseline for Cycle 2, Day 1||||<0.0001
72346939|NCT00265317|144215795|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon Rank Sum Test|||sKIT Ratio to Baseline for Cycle 3, Day 1||||<0.0001
72346940|NCT00265317|144215800|SUPERIORITY_OR_OTHER|||||||0.3681||95.0||||2-sided normal approximated p-value|Wilcoxon Rank Sum Test|||||||0.3681
72346941|NCT00265317|144215801|SUPERIORITY_OR_OTHER|||||||0.5982||95.0||||2-sided normal approximated p-value|Wilcoxon Rank Sum Test|||||||0.5982
72346942|NCT00265317|144215802|SUPERIORITY_OR_OTHER|||||||0.9807||95.0||||2-sided normal approximated p-value|Wilcoxon Rank Sum Test|||||||0.9807
72346943|NCT00265317|144215803|SUPERIORITY_OR_OTHER|||||||0.3945||||||2-sided normal approximated p-value|Wilcoxon Rank Sum Test|||||||0.3945
72346944|NCT00303485|144215854|SUPERIORITY_OR_OTHER||Difference in median|-64.2|||<|0.0001|TWO_SIDED|95.0|-80.28|-46.21|||Wilcoxon rank sum test|||||-46.21|-80.28|< 0.0001
72346945|NCT03928717|144215864|SUPERIORITY||Mean Difference (Final Values)|0.01|||<|0.05|TWO_SIDED||||||ANOVA|||||||<0.05
72346946|NCT03928717|144215865|SUPERIORITY||Mean Difference (Final Values)|0.16|||<|0.05|TWO_SIDED||||||ANOVA|||||||<0.05
72346947|NCT04120402|144215866|SUPERIORITY|||||||0.004|||||||ANCOVA|||||||0.004
72346948|NCT04120402|144215867|SUPERIORITY|||||||0.014|||||||ANCOVA|||||||0.014
72346949|NCT04120402|144215868|SUPERIORITY||||||<|0.001|||||||ANCOVA|||||||<0.001
72346950|NCT04120402|144215869|SUPERIORITY|||||||0.518|||||||ANCOVA|||||||0.518
72346951|NCT04120402|144215870|SUPERIORITY|||||||0.028|||||||Fisher Exact|||||||0.028
72346952|NCT00082407|144215876|NON_INFERIORITY_OR_EQUIVALENCE|Pre-specified non-inferiority margin was 0.4% (i.e., noninferiority is demonstrated if the upper limit of a two-sided 95% confidence interval for the difference in change in HbA1c between exenatide and biphasic insulin aspart is less than 0.4%.)|Mean Difference (Final Values)|-0.1||||0.2534||95.0|-0.28|0.08|||ANCOVA|||||0.08|-0.28|0.2534
72346953|NCT00082407|144215877|SUPERIORITY_OR_OTHER|||||||0.0779||95.0|||||Fisher Exact|||||||0.0779
72346954|NCT00082407|144215878|SUPERIORITY_OR_OTHER|||||||0.0001||95.0|||||ANCOVA|||||||0.0001
72346955|NCT00082407|144215879|SUPERIORITY_OR_OTHER|||||||0.6456||95.0|||||ANCOVA|||||||0.6456
72346956|NCT00082407|144215881|SUPERIORITY_OR_OTHER|||||||0.7888||95.0|||||Fisher Exact|||||||0.7888
72346957|NCT00082407|144215882|SUPERIORITY_OR_OTHER|||||||0.3722||95.0|||||ANCOVA|||||||0.3722
72346958|NCT00118742|144215891|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|24.9||||0.0012||95.0|14.8|35.0|||ANCOVA|||||35.0|14.8|0.0012
72346959|NCT00118742|144215892|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|25.6|||<|0.0001||95.0|15.7|35.6|||ANCOVA|||||35.6|15.7|<0.0001
72346960|NCT00118742|144215893|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|28.7||||0.0053||95.0|13.7|43.7|||ANCOVA|||||43.7|13.7|0.0053
72346961|NCT00118742|144215894|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|21.1|||<|0.0001||95.0|12.5|29.6|||ANCOVA|||Statistical analysis for calculated creatinine clearance at 6 months posttransplant||29.6|12.5|<0.0001
72346962|NCT00118742|144215894|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|18.2|||<|0.0001||95.0|9.9|26.6|||ANCOVA|||Statistical analysis for calculated creatinine clearance at 12 months posttransplant||26.6|9.9|<0.0001
72346963|NCT00118742|144215894|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|23.6||||0.0006||95.0|10.2|37.0|||ANCOVA|||Statistical analysis for calculated creatinine clearance at 24 months posttransplant||37.0|10.2|0.0006
72346964|NCT00711971|144215909|SUPERIORITY_OR_OTHER|||||||0.29|||||||ANOVA|||Significance for the BDI test at 26-28 weeks||||.29
72346965|NCT00711971|144215909|SUPERIORITY_OR_OTHER|||||||0.51|||||||ANOVA|||Significance for BDI at 34-36 weeks gestation||||.51
72346966|NCT00711971|144215909|SUPERIORITY_OR_OTHER|||||||0.56|||||||ANOVA|||BDI score at 6-8 weeks postpartum||||.56
72346967|NCT00711971|144215910|SUPERIORITY_OR_OTHER|||||||0.06|||||||Fisher Exact|||Gestational diabetes mellitus||||.06
72346968|NCT00711971|144215910|SUPERIORITY_OR_OTHER|||||||0.12|||||||Fisher Exact|||Hypertension or preeclampsia||||.12
72346969|NCT00711971|144215910|SUPERIORITY_OR_OTHER|||||||0.2|||||||Fisher Exact|||Induced labor||||.20
72346970|NCT00711971|144215910|SUPERIORITY_OR_OTHER|||||||0.08|||||||Fisher Exact|||Cesarean section||||.08
72346971|NCT00711971|144215910|SUPERIORITY_OR_OTHER|||||||0.88|||||||Fisher Exact|||Spontaneous vaginal delivery||||.88
72346972|NCT00711971|144215910|SUPERIORITY_OR_OTHER|||||||0.32|||||||Fisher Exact|||Operative vaginal delivery||||.32
72346973|NCT00711971|144215911|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||||||<.0001
72346974|NCT00711971|144215912|SUPERIORITY_OR_OTHER|||||||0.81|||||||ANOVA|||||||.81
72346975|NCT00711971|144215913|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA|Kruskal-Wallis test was used for outliers; Tukey multiple comparisons test was also used.||||||<.001
72346976|NCT00711971|144215914|SUPERIORITY_OR_OTHER|||||||0.39|||||||ANOVA|||||||.39
72346977|NCT00711971|144215915|SUPERIORITY_OR_OTHER|||||||0.19|||||||ANOVA|||||||.19
72346978|NCT00711971|144215916|SUPERIORITY_OR_OTHER||||||<|0.01|||||||ANOVA|||||||<0.01
72346979|NCT00711971|144215917|SUPERIORITY_OR_OTHER|||||||0.54|||||||ANOVA|||||||0.54
72346980|NCT01363908|144215925|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0781|TWO_SIDED|||||The P-value was from the analysis of Wilcoxon signed rank test at post-treatment time point vs baseline.|Wilcoxon signed rank test|||Analysis of 6 to \<12 year olds at 24 weeks||||0.0781
72346981|NCT01363908|144215925|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5|TWO_SIDED|||||The P-value was from the analysis of Wilcoxon signed rank test at post-treatment time point vs baseline.|Wilcoxon signed rank test|||Analysis of 6 to \<12 year olds at 48 weeks||||0.5000
72346982|NCT01363908|144215925|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2609|TWO_SIDED|||||The P-value was from the analysis of Wilcoxon signed rank test at post-treatment time point vs baseline.|Wilcoxon signed rank test|||Analysis of 12 to \<18 year olds at 24 weeks||||0.2609
72346983|NCT01363908|144215925|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9219|TWO_SIDED|||||The P-value was from the analysis of Wilcoxon signed rank test at post-treatment time point vs baseline.|Wilcoxon signed rank test|||Analysis of 12 to \<18 year olds at 48 weeks||||0.9219
72346984|NCT01363908|144215927|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6875|TWO_SIDED|||||The P-value was from analysis of Wilcoxon signed-rank test at post-treatment time point vs. baseline.|Wilcoxon signed-rank test|||Analysis of 6 to \<12 year olds at 24 weeks||||0.6875
72346985|NCT01363908|144215927|SUPERIORITY_OR_OTHER_LEGACY|||||||1|TWO_SIDED|||||The P-value was from analysis of Wilcoxon signed-rank test at post-treatment time point vs. baseline.|Wilcoxon signed-rank test|||Analysis of 6 to \<12 year olds at 48 weeks||||1.0000
72346986|NCT01363908|144215927|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8181|TWO_SIDED|||||The P-value was from analysis of Wilcoxon signed-rank test at post-treatment time point vs. baseline.|Wilcoxon signed-rank test|||Analysis of 12 to \<18 year olds at 24 weeks||||0.8181
72346987|NCT01363908|144215927|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5566|TWO_SIDED|||||P-value was from analysis of Wilcoxon signed-rank test at post-treatment time point vs. baseline.|Wilcoxon signed-rank|||Analysis of 12 to \<18 year olds at 48 weeks||||0.5566
72346988|NCT01363908|144215929|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0475|TWO_SIDED|||||The P-value was from paired t test for log-transformed data at post-treatment time point vs. baseline.|paired t test|||Analysis of 6 to \<12 year olds at 24 weeks||||0.0475
72346989|NCT01363908|144215929|SUPERIORITY_OR_OTHER_LEGACY|||||||0.441|TWO_SIDED|||||The P-value was from paired t test for log-transformed data at post-treatment time point vs. baseline.|paired t test|The P-value was from paired t test for log-transformed data at post-treatment time point vs. baseline.||Analysis of 6 to \<12 year olds at 48 weeks||||0.4410
72346990|NCT01363908|144215929|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0417|TWO_SIDED|||||The P-value was from paired t test for log-transformed data at post-treatment time point vs. baseline.|paired t test|||Analysis of 12 to \<18 year olds at 24 weeks||||0.0417
72346991|NCT01363908|144215929|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0409|TWO_SIDED|||||The P-value was from paired t test for log-transformed data at post-treatment time point vs. baseline.|paired t test|||Analysis of 12 to \<18 year olds at 48 weeks||||0.0409
72346992|NCT01363908|144215930|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9901|TWO_SIDED|||||The P-value was from paired t test for log-transformed data at post-treatment time point vs. baseline.|paired t test|||Analysis of 6 to \<12 year olds at 24 weeks||||0.9901
72346993|NCT01363908|144215930|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3039|TWO_SIDED|||||The P-value was from paired t test for log-transformed data at post-treatment time point vs. baseline.|paired t test|||Analysis of 6 to \<12 year olds at 48 weeks||||0.3039
72346994|NCT01363908|144215930|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0044|TWO_SIDED|||||The P-value was from paired t test for log-transformed data at post-treatment time point vs. baseline.|paired t test|||Analysis of 12 to \<18 year olds at 24 weeks||||0.0044
72346995|NCT01363908|144215930|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0395|TWO_SIDED|||||The P-value was from paired t test for log-transformed data at post-treatment time point vs. baseline.|paired t test|||Analysis of 12 to \<18 year olds at 48 weeks||||0.0395
72346996|NCT00536471|144215933|SUPERIORITY_OR_OTHER|||||||0.051||95.0||||Repeated Measures Analysis for Group A change from baseline to 8 week endpoint.|Mixed Models Analysis|Model=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit||||||0.051
72346997|NCT00536471|144215933|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Repeated Measures Analysis for Group B change from baseline to 8 week endpoint.|Mixed Models Analysis|Model=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit||||||<0.001
72346998|NCT00536471|144215934|SUPERIORITY_OR_OTHER|||||||0.013||95.0||||P-value for Total Score 12 Week Change. Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit|Mixed Models Analysis|||||||0.013
72346999|NCT00536471|144215934|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Total Score 12 Week Change. Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit|Mixed Models Analysis|||||||<0.001
72347000|NCT00536471|144215934|SUPERIORITY_OR_OTHER|||||||0.026||95.0||||P-value for Maier 8 Week Change. Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit|Mixed Models Analysis|||||||0.026
72347001|NCT00536471|144215934|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Maier 8 Week Change. Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit|Mixed Models Analysis|||||||<0.001
72347002|NCT00536471|144215934|SUPERIORITY_OR_OTHER|||||||0.202||95.0||||P-value for Anxiety/Somatization 12 Week Change. Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit|Mixed Models Analysis|||||||0.202
72347003|NCT00536471|144215934|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Anxiety/Somatization 12 Week Change. Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit|Mixed Models Analysis|||||||<0.001
72347004|NCT00536471|144215934|SUPERIORITY_OR_OTHER|||||||0.027||95.0||||P-value for Bech 12 Week Change. Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit|Mixed Models Analysis|||||||0.027
72347005|NCT00536471|144215934|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Bech 12 Week Change. Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit|Mixed Models Analysis|||||||<0.001
72347006|NCT00536471|144215934|SUPERIORITY_OR_OTHER|||||||0.076||95.0||||P-value for Retardation 12 Week Change. Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit|Mixed Models Analysis|||||||0.076
72347007|NCT00536471|144215934|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Retardation 12 Week Change. Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit|Mixed Models Analysis|||||||<0.001
72347008|NCT00536471|144215934|SUPERIORITY_OR_OTHER|||||||0.149||95.0||||P-value for Sleep 12 Week Change. Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit|Mixed Models Analysis|||||||0.149
72347009|NCT00536471|144215934|SUPERIORITY_OR_OTHER|||||||0.062||95.0||||P-value for Sleep 12 Week Change. Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit|Mixed Models Analysis|||||||0.062
72347010|NCT00536471|144215934|SUPERIORITY_OR_OTHER|||||||0.629||95.0||||P-value for Total Score 9 Month Change. Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit|Mixed Models Analysis|||||||0.629
72347011|NCT00536471|144215934|SUPERIORITY_OR_OTHER|||||||0.194||95.0||||P-value for Total Score 9 Month Change. Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit|Mixed Models Analysis|||||||0.194
72347012|NCT00536471|144215934|SUPERIORITY_OR_OTHER|||||||0.525||95.0||||P-value for Maier 9 Month Change. Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit|Mixed Models Analysis|||||||0.525
72347013|NCT00536471|144215934|SUPERIORITY_OR_OTHER|||||||0.595||95.0||||P-value for Maier 9 Month Change. Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit|Mixed Models Analysis|||||||0.595
72347014|NCT00536471|144215934|SUPERIORITY_OR_OTHER|||||||0.736||95.0||||P-value for Anxiety/Somatization 9 Month Change. Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit|Mixed Models Analysis|||||||0.736
72347015|NCT00536471|144215934|SUPERIORITY_OR_OTHER|||||||0.368||95.0||||P-value for Anxiety/Somatization 9 Month Change. Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit|Mixed Models Analysis|||||||0.368
72347016|NCT00536471|144215934|SUPERIORITY_OR_OTHER|||||||0.66||95.0||||P-value for Bech 9 Month Change. Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit|Mixed Models Analysis|||||||0.660
72429053|NCT02404493|144368948|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.31||0.699|TWO_SIDED|95.0|-0.824|0.574||The significance level threshold level was 0.05.|ANCOVA|Change from baseline as response, baseline score as covariate and treatment as factor.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.574|-0.824|0.699
72347017|NCT00536471|144215934|SUPERIORITY_OR_OTHER|||||||0.334||95.0||||P-value for Bech 9 Month Change. Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit|Mixed Models Analysis|||||||0.334
72347018|NCT00536471|144215934|SUPERIORITY_OR_OTHER|||||||0.568||95.0||||P-value for Retardation 9 Month Change. Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit|Mixed Models Analysis|||||||0.568
72347019|NCT00536471|144215934|SUPERIORITY_OR_OTHER|||||||0.216||95.0||||P-value for Retardation 9 Month Change. Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit|Mixed Models Analysis|||||||0.216
72347020|NCT00536471|144215934|SUPERIORITY_OR_OTHER|||||||0.646||95.0||||P-value for Sleep 9 Month Change. Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit|Mixed Models Analysis|||||||0.646
72347021|NCT00536471|144215934|SUPERIORITY_OR_OTHER|||||||0.275||95.0||||P-value for Sleep 9 Month Change. Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit|Mixed Models Analysis|||||||0.275
72347022|NCT00536471|144215935|SUPERIORITY_OR_OTHER|||||||0.011||95.0||||P-value for 12 Week Change. Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.011
72347023|NCT00536471|144215935|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for 12 Week Change. Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. (Change=Endpoint minus baseline)|Mixed Models Analysis|||||||<0.001
72347024|NCT00536471|144215935|SUPERIORITY_OR_OTHER|||||||0.449||95.0||||P-value for 9 Month Change. Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.449
72347025|NCT00536471|144215935|SUPERIORITY_OR_OTHER|||||||0.167||95.0||||P-value for 9 Month Change. Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.167
72347026|NCT00536471|144215936|SUPERIORITY_OR_OTHER|||||||0.016||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.016
72347027|NCT00536471|144215936|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||<0.001
72347028|NCT00536471|144215936|SUPERIORITY_OR_OTHER|||||||0.653||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.653
72347029|NCT00536471|144215936|SUPERIORITY_OR_OTHER|||||||0.417||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.417
72347030|NCT00536471|144215937|SUPERIORITY_OR_OTHER|||||||0.204||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change(Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.204
72347031|NCT00536471|144215937|SUPERIORITY_OR_OTHER|||||||0.011||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.011
72347032|NCT00536471|144215937|SUPERIORITY_OR_OTHER|||||||0.571||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.571
72347033|NCT00536471|144215937|SUPERIORITY_OR_OTHER|||||||0.133||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.133
72347034|NCT00536471|144215938|SUPERIORITY_OR_OTHER|||||||0.023||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.023
72347035|NCT00536471|144215938|SUPERIORITY_OR_OTHER|||||||0.1||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.100
72347036|NCT00536471|144215938|SUPERIORITY_OR_OTHER|||||||0.571||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.571
72347037|NCT00536471|144215938|SUPERIORITY_OR_OTHER|||||||0.133||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.133
72347038|NCT00536471|144215939|SUPERIORITY_OR_OTHER|||||||0.332||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.332
72347039|NCT00536471|144215939|SUPERIORITY_OR_OTHER|||||||0.041||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.041
72429054|NCT02404493|144368949|SUPERIORITY_OR_OTHER||||||<|0.001||||||The significance level threshold level was 0.05.|One sample t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||<0.001
72347040|NCT00536471|144215939|SUPERIORITY_OR_OTHER|||||||0.775||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.775
72347041|NCT00536471|144215939|SUPERIORITY_OR_OTHER|||||||0.588||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.588
72347042|NCT00536471|144215940|SUPERIORITY_OR_OTHER|||||||0.624||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.624
72347043|NCT00536471|144215940|SUPERIORITY_OR_OTHER|||||||0.473||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.473
72347044|NCT00536471|144215940|SUPERIORITY_OR_OTHER|||||||0.787||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.787
72347045|NCT00536471|144215940|SUPERIORITY_OR_OTHER|||||||0.086||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.086
72347046|NCT00536471|144215941|SUPERIORITY_OR_OTHER|||||||0.099||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.099
72347047|NCT00536471|144215941|SUPERIORITY_OR_OTHER|||||||0.223||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.223
72347048|NCT00536471|144215941|SUPERIORITY_OR_OTHER|||||||0.473||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.473
72347049|NCT00536471|144215941|SUPERIORITY_OR_OTHER|||||||0.233||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.233
72347050|NCT00536471|144215942|SUPERIORITY_OR_OTHER|||||||0.577||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.577
72347051|NCT00536471|144215942|SUPERIORITY_OR_OTHER|||||||0.567||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.567
72347052|NCT00536471|144215943|SUPERIORITY_OR_OTHER|||||||0.67||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.670
72347053|NCT00536471|144215943|SUPERIORITY_OR_OTHER|||||||0.059||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.059
72347054|NCT00536471|144215943|SUPERIORITY_OR_OTHER|||||||0.93||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.930
72347055|NCT00536471|144215943|SUPERIORITY_OR_OTHER|||||||0.567||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.567
72347056|NCT00536471|144215944|SUPERIORITY_OR_OTHER|||||||0.896||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.896
72347057|NCT00536471|144215944|SUPERIORITY_OR_OTHER|||||||0.796||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.796
72347058|NCT00536471|144215944|SUPERIORITY_OR_OTHER|||||||0.571||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.571
72347059|NCT00536471|144215944|SUPERIORITY_OR_OTHER|||||||0.381||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.381
72347060|NCT00536471|144215945|SUPERIORITY_OR_OTHER|||||||0.038||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.038
72347061|NCT00536471|144215945|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.002
72347062|NCT00536471|144215945|SUPERIORITY_OR_OTHER|||||||0.665||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.665
72347063|NCT00536471|144215945|SUPERIORITY_OR_OTHER|||||||0.253||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.253
72347064|NCT00536471|144215946|SUPERIORITY_OR_OTHER|||||||0.723||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.723
72429055|NCT02404493|144368949|SUPERIORITY_OR_OTHER|||||||0.058||||||The significance level threshold level was 0.05.|One sample t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||0.058
72347065|NCT00536471|144215946|SUPERIORITY_OR_OTHER|||||||0.312||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.312
72347066|NCT00536471|144215946|SUPERIORITY_OR_OTHER|||||||0.853||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.853
72347067|NCT00536471|144215946|SUPERIORITY_OR_OTHER|||||||0.913||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.913
72347068|NCT00536471|144215947|SUPERIORITY_OR_OTHER|||||||0.234||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.234
72347069|NCT00536471|144215947|SUPERIORITY_OR_OTHER|||||||0.216||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.216
72347070|NCT00536471|144215947|SUPERIORITY_OR_OTHER|||||||0.853||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.853
72347071|NCT00536471|144215947|SUPERIORITY_OR_OTHER|||||||0.908||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.908
72347072|NCT00536471|144215948|SUPERIORITY_OR_OTHER|||||||0.789||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.789
72347073|NCT00536471|144215948|SUPERIORITY_OR_OTHER|||||||0.012||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.012
72347074|NCT00536471|144215948|SUPERIORITY_OR_OTHER|||||||0.414||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.414
72347075|NCT00536471|144215948|SUPERIORITY_OR_OTHER|||||||0.717||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.717
72347076|NCT00536471|144215949|SUPERIORITY_OR_OTHER|||||||0.78||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.780
72347077|NCT00536471|144215949|SUPERIORITY_OR_OTHER|||||||0.152||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.152
72347078|NCT00536471|144215949|SUPERIORITY_OR_OTHER|||||||0.637||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.637
72347079|NCT00536471|144215949|SUPERIORITY_OR_OTHER|||||||0.024||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.024
72347080|NCT00536471|144215950|SUPERIORITY_OR_OTHER|||||||0.517||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.517
72347081|NCT00536471|144215950|SUPERIORITY_OR_OTHER|||||||0.256||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.256
72347082|NCT00536471|144215950|SUPERIORITY_OR_OTHER|||||||1||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||1.000
72347083|NCT00536471|144215950|SUPERIORITY_OR_OTHER|||||||0.268||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.268
72347084|NCT00536471|144215951|SUPERIORITY_OR_OTHER|||||||0.741||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.741
72347085|NCT00536471|144215951|SUPERIORITY_OR_OTHER|||||||0.722||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.722
72347086|NCT00536471|144215951|SUPERIORITY_OR_OTHER|||||||1||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||1.000
72347087|NCT00536471|144215951|SUPERIORITY_OR_OTHER|||||||0.268||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.268
72347088|NCT00536471|144215952|SUPERIORITY_OR_OTHER|||||||0.723||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.723
72347089|NCT00536471|144215952|SUPERIORITY_OR_OTHER|||||||0.949||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.949
72347090|NCT00536471|144215952|SUPERIORITY_OR_OTHER|||||||1||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||1.000
72347091|NCT00536471|144215952|SUPERIORITY_OR_OTHER|||||||0.268||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.268
72347092|NCT00536471|144215953|SUPERIORITY_OR_OTHER|||||||0.682||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.682
72347093|NCT00536471|144215953|SUPERIORITY_OR_OTHER|||||||0.001||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.001
72347094|NCT00536471|144215953|SUPERIORITY_OR_OTHER|||||||0.2||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.200
72347095|NCT00536471|144215953|SUPERIORITY_OR_OTHER|||||||0.813||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.813
72347096|NCT00536471|144215954|SUPERIORITY_OR_OTHER|||||||0.438||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.438
72347097|NCT00536471|144215954|SUPERIORITY_OR_OTHER|||||||0.018||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.018
72347098|NCT00536471|144215954|SUPERIORITY_OR_OTHER|||||||0.692||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.692
72347099|NCT00536471|144215954|SUPERIORITY_OR_OTHER|||||||0.668||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.668
72347100|NCT00536471|144215955|SUPERIORITY_OR_OTHER|||||||0.588||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.588
72347101|NCT00536471|144215955|SUPERIORITY_OR_OTHER|||||||0.758||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.758
72347102|NCT00536471|144215955|SUPERIORITY_OR_OTHER|||||||0.692||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.692
72347103|NCT00536471|144215955|SUPERIORITY_OR_OTHER|||||||0.668||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.668
72347104|NCT00536471|144215956|SUPERIORITY_OR_OTHER|||||||0.507||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.507
72347105|NCT00536471|144215956|SUPERIORITY_OR_OTHER|||||||0.466||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.466
72347106|NCT00536471|144215956|SUPERIORITY_OR_OTHER|||||||0.692||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.692
72347107|NCT00536471|144215956|SUPERIORITY_OR_OTHER|||||||0.668||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.668
72347108|NCT00536471|144215957|SUPERIORITY_OR_OTHER|||||||0.487||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.487
72347109|NCT00536471|144215957|SUPERIORITY_OR_OTHER|||||||0.678||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.678
72347110|NCT00536471|144215957|SUPERIORITY_OR_OTHER|||||||0.692||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.692
72347111|NCT00536471|144215957|SUPERIORITY_OR_OTHER|||||||0.668||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.668
72347112|NCT00536471|144215958|SUPERIORITY_OR_OTHER|||||||0.505||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.505
72347113|NCT00536471|144215958|SUPERIORITY_OR_OTHER|||||||0.135||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.135
72347114|NCT00536471|144215958|SUPERIORITY_OR_OTHER|||||||0.175||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.175
72347115|NCT00536471|144215958|SUPERIORITY_OR_OTHER|||||||1||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||1.000
72347116|NCT00536471|144215959|SUPERIORITY_OR_OTHER|||||||0.175||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.175
72347117|NCT00536471|144215959|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.002
72347118|NCT00536471|144215959|SUPERIORITY_OR_OTHER|||||||0.576||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.576
72347119|NCT00536471|144215959|SUPERIORITY_OR_OTHER|||||||0.676||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.676
72347120|NCT00536471|144215960|SUPERIORITY_OR_OTHER|||||||0.675||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.675
72347121|NCT00536471|144215960|SUPERIORITY_OR_OTHER|||||||0.139||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.139
72347122|NCT00536471|144215960|SUPERIORITY_OR_OTHER|||||||0.576||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.576
72347123|NCT00536471|144215960|SUPERIORITY_OR_OTHER|||||||0.676||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.676
72347124|NCT00536471|144215961|SUPERIORITY_OR_OTHER|||||||0.007||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Total Score (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.007
72347125|NCT00536471|144215961|SUPERIORITY_OR_OTHER|||||||0.031||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Total Score (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.031
72347126|NCT00536471|144215961|SUPERIORITY_OR_OTHER|||||||0.02||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Tension-Anxiety (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.020
72347127|NCT00536471|144215961|SUPERIORITY_OR_OTHER|||||||0.324||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Tension-Anxiety (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.324
72347128|NCT00536471|144215961|SUPERIORITY_OR_OTHER|||||||0.01||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Depression-Dejection (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.010
72347129|NCT00536471|144215961|SUPERIORITY_OR_OTHER|||||||0.005||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Depression-Dejection (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.005
72347130|NCT00536471|144215961|SUPERIORITY_OR_OTHER|||||||0.01||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Anger-Hostility (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.010
72347131|NCT00536471|144215961|SUPERIORITY_OR_OTHER|||||||0.019||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Anger-Hostility (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.019
72347132|NCT00536471|144215961|SUPERIORITY_OR_OTHER|||||||0.201||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Vigor-Activity (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.201
72347133|NCT00536471|144215961|SUPERIORITY_OR_OTHER|||||||0.069||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Vigor-Activity (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.069
72347134|NCT00536471|144215961|SUPERIORITY_OR_OTHER|||||||0.368||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Fatigue-Inertia (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.368
72347135|NCT00536471|144215961|SUPERIORITY_OR_OTHER|||||||0.435||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Fatigue-Inertia (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.435
72347136|NCT00536471|144215961|SUPERIORITY_OR_OTHER|||||||0.09||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Confusion-Bewilderment (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.090
72347137|NCT00536471|144215961|SUPERIORITY_OR_OTHER|||||||0.313||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Confusion-Bewilderment (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.313
72347138|NCT00536471|144215962|SUPERIORITY_OR_OTHER|||||||0.639||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Total Score (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.639
72347139|NCT00536471|144215962|SUPERIORITY_OR_OTHER|||||||0.584||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Total Score (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.584
72347140|NCT00536471|144215962|SUPERIORITY_OR_OTHER|||||||0.251||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Tension-Anxiety (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.251
72347141|NCT00536471|144215962|SUPERIORITY_OR_OTHER|||||||0.265||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Tension-Anxiety (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.265
72347142|NCT00536471|144215962|SUPERIORITY_OR_OTHER|||||||0.366||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Depression-Dejection (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.366
72347143|NCT00536471|144215962|SUPERIORITY_OR_OTHER|||||||0.257||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Depression-Dejection (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.257
72347144|NCT00536471|144215962|SUPERIORITY_OR_OTHER|||||||0.426||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Anger-Hostility (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.426
72347145|NCT00536471|144215962|SUPERIORITY_OR_OTHER|||||||0.234||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Anger-Hostility (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.234
72347146|NCT00536471|144215962|SUPERIORITY_OR_OTHER|||||||0.765||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Vigor-Activity (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.765
72347147|NCT00536471|144215962|SUPERIORITY_OR_OTHER|||||||0.522||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Vigor-Activity (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.522
72347148|NCT00536471|144215962|SUPERIORITY_OR_OTHER|||||||0.986||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Fatigue-Inertia (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.986
72347149|NCT00536471|144215962|SUPERIORITY_OR_OTHER|||||||0.602||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Fatigue-Inertia (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.602
72347150|NCT00536471|144215962|SUPERIORITY_OR_OTHER|||||||0.11||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Confusion-Bewilderment (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.110
72347151|NCT00536471|144215962|SUPERIORITY_OR_OTHER|||||||0.505||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Confusion-Bewilderment(Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.505
72347152|NCT00536471|144215963|SUPERIORITY_OR_OTHER|||||||0.366||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Work Life (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.366
72347153|NCT00536471|144215963|SUPERIORITY_OR_OTHER|||||||0.065||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Work Life (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.065
72347154|NCT00536471|144215963|SUPERIORITY_OR_OTHER|||||||0.229||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Social Life (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.229
72347155|NCT00536471|144215963|SUPERIORITY_OR_OTHER|||||||0.044||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Social Life (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.044
72347156|NCT00536471|144215963|SUPERIORITY_OR_OTHER|||||||0.092||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Family Life (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.092
72347157|NCT00536471|144215963|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Family Life (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.002
72347158|NCT00536471|144215963|SUPERIORITY_OR_OTHER|||||||0.142||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Total Score(Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.142
72347159|NCT00536471|144215963|SUPERIORITY_OR_OTHER|||||||0.005||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Total Score (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.005
72347160|NCT00536471|144215964|SUPERIORITY_OR_OTHER|||||||0.921||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Work Life (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.921
72347161|NCT00536471|144215964|SUPERIORITY_OR_OTHER|||||||0.895||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Work Life (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.895
72347162|NCT00536471|144215964|SUPERIORITY_OR_OTHER|||||||0.789||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Social Life (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.789
72347163|NCT00536471|144215964|SUPERIORITY_OR_OTHER|||||||0.761||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Social Life (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.761
72347164|NCT00536471|144215964|SUPERIORITY_OR_OTHER|||||||0.519||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Family Life (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.519
72347165|NCT00536471|144215964|SUPERIORITY_OR_OTHER|||||||0.755||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Family Life (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.755
72347166|NCT00536471|144215964|SUPERIORITY_OR_OTHER|||||||0.829||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Total Score (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.829
72347167|NCT00536471|144215964|SUPERIORITY_OR_OTHER|||||||0.723||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Total Score (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.723
72347168|NCT00536471|144215965|SUPERIORITY_OR_OTHER|||||||0.753||95.0||||P-value for Direct Treatment Effect|Regression, Linear|||||||0.753
72347169|NCT00536471|144215965|SUPERIORITY_OR_OTHER|||||||0.036||95.0||||P-value for Direct Treatment Effect|Regression, Linear|||||||0.036
72347170|NCT00536471|144215967|SUPERIORITY_OR_OTHER|||||||0.342||95.0||||P-value for Direct Treatment Effect|Regression, Linear|||||||0.342
72347171|NCT00536471|144215967|SUPERIORITY_OR_OTHER|||||||0.111||95.0||||P-value for Direct Treatment Effect|Regression, Linear|||||||0.111
72347172|NCT00536471|144215969|SUPERIORITY_OR_OTHER|||||||0.302||95.0||||P-value for 12 Week Change. Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.302
72347173|NCT00536471|144215969|SUPERIORITY_OR_OTHER|||||||0.029||95.0||||P-value for 12 Week Change. Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.029
72347174|NCT00536471|144215969|SUPERIORITY_OR_OTHER|||||||0.325||95.0||||P-value for 9 Month Change. Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.325
72347175|NCT00536471|144215969|SUPERIORITY_OR_OTHER|||||||0.423||95.0||||P-value for 9 Month Change. Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.423
72347176|NCT00536471|144215970|SUPERIORITY_OR_OTHER|||||||0.731||95.0||||P-value for 12 Week HAMD-17. Model=Baseline, Pooled Investigator, Visit, Treatment, and Treatment\*Visit.|Mixed Models Analysis|||||||0.731
72347177|NCT00536471|144215970|SUPERIORITY_OR_OTHER|||||||0.022||95.0||||P-value for 12 Week HAMD-17. Model=Baseline, Pooled Investigator, Visit, Treatment, and Treatment\*Visit.|Mixed Models Analysis|||||||0.022
72347178|NCT00536471|144215970|SUPERIORITY_OR_OTHER|||||||0.948||95.0||||P-value for 12 Week QIDS16. Model=Baseline, Pooled Investigator, Visit, Treatment, and Treatment\*Visit.|Mixed Models Analysis|||||||0.948
72347179|NCT00536471|144215970|SUPERIORITY_OR_OTHER|||||||0.022||95.0||||P-value for 12 Week QIDS16. Model=Baseline, Pooled Investigator, Visit, Treatment, and Treatment\*Visit.|Mixed Models Analysis|||||||0.022
72347180|NCT00536471|144215970|SUPERIORITY_OR_OTHER|||||||0.95||95.0||||P-value for 9 Month HAMD-17. Model=Baseline, Pooled Investigator, Visit, Treatment, and Treatment\*Visit.|Mixed Models Analysis|||||||0.950
72347181|NCT00536471|144215970|SUPERIORITY_OR_OTHER|||||||0.442||95.0||||P-value for 9 Month HAMD-17. Model=Baseline, Pooled Investigator, Visit, Treatment, and Treatment\*Visit.|Mixed Models Analysis|||||||0.442
72347182|NCT00536471|144215970|SUPERIORITY_OR_OTHER|||||||0.218||95.0||||P-value for 9 Month QIDS16. Model=Baseline, Pooled Investigator, Visit, Treatment, and Treatment\*Visit.|Mixed Models Analysis|||||||0.218
72347183|NCT00536471|144215970|SUPERIORITY_OR_OTHER|||||||0.648||95.0||||P-value for 9 Month QIDS16. Model=Baseline, Pooled Investigator, Visit, Treatment, and Treatment\*Visit.|Mixed Models Analysis|||||||0.648
72347184|NCT00536471|144215971|SUPERIORITY_OR_OTHER|||||||0.653||95.0||||P-value for 12 week HAMD-17. Model=Baseline, Pooled Investigator, Visit, Treatment, and Treatment\*Visit.|Mixed Models Analysis|||||||0.653
72347185|NCT00536471|144215971|SUPERIORITY_OR_OTHER|||||||0.016||95.0||||P-value for 12 week HAMD-17. Model=Baseline, Pooled Investigator, Visit, Treatment, and Treatment\*Visit.|Mixed Models Analysis|||||||0.016
72347186|NCT00536471|144215971|SUPERIORITY_OR_OTHER|||||||0.665||95.0||||P-value for 12 week QIDS16. Model=Baseline, Pooled Investigator, Visit, Treatment, and Treatment\*Visit.|Mixed Models Analysis|||||||0.665
72347187|NCT00536471|144215971|SUPERIORITY_OR_OTHER|||||||0.127||95.0||||P-value for 12 week QIDS16. Model=Baseline, Pooled Investigator, Visit, Treatment, and Treatment\*Visit.|Mixed Models Analysis|||||||0.127
72347188|NCT00536471|144215972|SUPERIORITY_OR_OTHER|||||||0.475||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Item 1 Average Pain Severity 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.475
72347189|NCT00536471|144215972|SUPERIORITY_OR_OTHER|||||||0.561||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Item 1 Average Pain Severity 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.561
72347190|NCT00536471|144215972|SUPERIORITY_OR_OTHER|||||||0.213||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Item 7 How Bothered by Pain 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.213
72347191|NCT00536471|144215972|SUPERIORITY_OR_OTHER|||||||0.536||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Item 7 How Bothered by Pain 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.536
72347192|NCT00536471|144215972|SUPERIORITY_OR_OTHER|||||||0.158||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Item 1 Average Pain Severity 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.158
72347193|NCT00536471|144215972|SUPERIORITY_OR_OTHER|||||||0.759||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Item 1 Average Pain Severity 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.759
72347194|NCT00536471|144215972|SUPERIORITY_OR_OTHER|||||||0.19||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Item 7 How Bothered by Pain 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.190
72347195|NCT00536471|144215972|SUPERIORITY_OR_OTHER|||||||0.852||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Item 7 How Bothered by Pain 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.852
72347196|NCT00536471|144215973|SUPERIORITY_OR_OTHER|||||||0.032||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.032
72347197|NCT00536471|144215973|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||<0.001
72347198|NCT00536471|144215973|SUPERIORITY_OR_OTHER|||||||0.705||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.705
72347199|NCT00536471|144215973|SUPERIORITY_OR_OTHER|||||||0.388||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.388
72347200|NCT00536471|144215974|SUPERIORITY_OR_OTHER|||||||0.161||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.161
72347201|NCT00536471|144215974|SUPERIORITY_OR_OTHER|||||||0.198||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.198
72347202|NCT00536471|144215974|SUPERIORITY_OR_OTHER|||||||0.982||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.982
72347203|NCT00536471|144215974|SUPERIORITY_OR_OTHER|||||||0.407||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.407
72347204|NCT00536471|144215975|SUPERIORITY_OR_OTHER|||||||0.001||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.001
72347205|NCT00536471|144215975|SUPERIORITY_OR_OTHER|||||||0.006||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.006
72347206|NCT00536471|144215975|SUPERIORITY_OR_OTHER|||||||0.231||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.231
72347207|NCT00536471|144215975|SUPERIORITY_OR_OTHER|||||||0.04||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.040
72347208|NCT00536471|144215976|SUPERIORITY_OR_OTHER|||||||0.914||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Systolic Blood Pressure 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.914
72347209|NCT00536471|144215976|SUPERIORITY_OR_OTHER|||||||0.011||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Systolic Blood Pressure 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.011
72347210|NCT00536471|144215976|SUPERIORITY_OR_OTHER|||||||0.296||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Diastolic Blood Pressure 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.296
72347211|NCT00536471|144215976|SUPERIORITY_OR_OTHER|||||||0.034||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Diastolic Blood Pressure 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.034
72347212|NCT00536471|144215976|SUPERIORITY_OR_OTHER|||||||0.874||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Systolic Blood Pressure (SBP) 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.874
72347213|NCT00536471|144215976|SUPERIORITY_OR_OTHER|||||||0.614||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Systolic Blood Pressure (SBP) 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.614
72347214|NCT00536471|144215976|SUPERIORITY_OR_OTHER|||||||0.146||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Diastolic Blood Pressure (DBP) 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.146
72347215|NCT00536471|144215976|SUPERIORITY_OR_OTHER|||||||0.877||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Diastolic Blood Pressure (DBP) 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.877
72347216|NCT00536471|144215977|SUPERIORITY_OR_OTHER|||||||0.012||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.012
72347217|NCT00536471|144215977|SUPERIORITY_OR_OTHER|||||||0.045||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.045
72347218|NCT00536471|144215977|SUPERIORITY_OR_OTHER|||||||0.701||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.701
72347219|NCT00536471|144215977|SUPERIORITY_OR_OTHER|||||||0.081||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.081
72347220|NCT00536471|144215978|SUPERIORITY_OR_OTHER|||||||0.013||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.013
72347221|NCT00536471|144215978|SUPERIORITY_OR_OTHER|||||||0.672||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.672
72347222|NCT00536471|144215978|SUPERIORITY_OR_OTHER|||||||0.874||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.874
72347223|NCT00536471|144215978|SUPERIORITY_OR_OTHER|||||||0.39||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.390
72347224|NCT00536471|144215983|SUPERIORITY_OR_OTHER|||||||0.046||95.0||||P-value for Bilirubin - 12 Week Change.|ANOVA|||||||0.046
72347225|NCT00536471|144215983|SUPERIORITY_OR_OTHER|||||||0.031||95.0||||P-value for Creatinine - 12 Week Change.|ANOVA|||||||0.031
72347226|NCT00536471|144215983|SUPERIORITY_OR_OTHER|||||||0.003||95.0||||P-value for Uric Acid - 12 Week Change.|ANOVA|||||||0.003
72347227|NCT00536471|144215983|SUPERIORITY_OR_OTHER|||||||0.033||95.0||||P-value for Bilirubin - 9 Month Change.|ANOVA|||||||0.033
72347228|NCT00536471|144215983|SUPERIORITY_OR_OTHER|||||||0.013||95.0||||P-value for Uric Acid - 9 Month Change.|ANOVA|||||||0.013
72347229|NCT00536471|144215984|SUPERIORITY_OR_OTHER|||||||0.037||95.0||||P-value for Hematocrit - 12 Week Change.|ANOVA|||||||0.037
72347230|NCT00536471|144215984|SUPERIORITY_OR_OTHER|||||||0.029||95.0||||P-value for Hematocrit - 9 Month Change.|ANOVA|||||||0.029
72347231|NCT00536471|144215985|SUPERIORITY_OR_OTHER|||||||0.013||95.0||||P-value for MCV - 12 Week Change.|ANOVA|||||||0.013
72347232|NCT00536471|144215985|SUPERIORITY_OR_OTHER|||||||0.014||95.0||||P-value for MCV - 9 Month Change.|ANOVA|||||||0.014
72347233|NCT00536471|144215986|SUPERIORITY_OR_OTHER|||||||0.022||95.0||||P-value for Chloride - 12 Week Change.|ANOVA|||||||0.022
72347234|NCT00536471|144215986|SUPERIORITY_OR_OTHER|||||||0.044||95.0||||P-value for Urea Nitrogen - 12 Week Change.|ANOVA|||||||0.044
72347235|NCT00536471|144215986|SUPERIORITY_OR_OTHER|||||||0.004||95.0||||P-value for Chloride - 9 Month Change.|ANOVA|||||||0.004
72347236|NCT00536471|144215986|SUPERIORITY_OR_OTHER|||||||0.045||95.0||||P-value for Cholesterol - 9 Month Change.|ANOVA|||||||0.045
72347237|NCT00536471|144215986|SUPERIORITY_OR_OTHER|||||||0.043||95.0||||P-value for Sodium - 9 Month Change.|ANOVA|||||||0.043
72347238|NCT00536471|144215987|SUPERIORITY_OR_OTHER|||||||0.017||95.0||||P-value for 12 Week Change.|ANOVA|||||||0.017
72347239|NCT00536471|144215987|SUPERIORITY_OR_OTHER|||||||0.003||95.0||||P-value for 9 Month Change.|ANOVA|||||||0.003
72347240|NCT00536471|144215988|SUPERIORITY_OR_OTHER|||||||0.033||95.0|||||ANOVA|||||||0.033
72347241|NCT00536471|144215989|SUPERIORITY_OR_OTHER|||||||0.045||95.0|||||ANOVA|||||||0.045
72347242|NCT00536471|144215990|SUPERIORITY_OR_OTHER|||||||0.041||95.0||||P-value for Lymphocytes - High.|Fisher Exact|||||||0.041
72347243|NCT00536471|144215990|SUPERIORITY_OR_OTHER|||||||0.048||95.0||||P-value for Potassium - Low.|Fisher Exact|||||||0.048
72347244|NCT00536471|144215991|SUPERIORITY_OR_OTHER|||||||0.012||95.0||||P-value for Lymphocytes - High.|Fisher Exact|||||||0.012
72347245|NCT00536471|144215991|SUPERIORITY_OR_OTHER|||||||0.049||95.0||||P-value for Potassium - Low.|Fisher Exact|||||||0.049
72347246|NCT00536471|144215992|SUPERIORITY_OR_OTHER|||||||0.012||95.0||||P-value for Lymphocytes - High.|Fisher Exact|||||||0.012
72347247|NCT00536471|144215992|SUPERIORITY_OR_OTHER|||||||0.038||95.0||||P-value for Hemoglobin - Low.|Fisher Exact|||||||0.038
72347248|NCT05173012|144216071|SUPERIORITY||Least Squares (LS) Mean Difference|0.39|STANDARD_ERROR_OF_MEAN|0.623||0.5325|TWO_SIDED|95.0|-0.84|1.62|||MMRM|MMRM model included treatment, baseline score, assessment timepoint, and timepoint-by-treatment as explanatory variables, treated as fixed effects.|Difference was calculated as Monotherapy: SAGE-324 15 mg - placebo.|||1.62|-0.84|0.5325
72347249|NCT05173012|144216071|SUPERIORITY||LS Mean Difference|-0.28|STANDARD_ERROR_OF_MEAN|0.634||0.6549|TWO_SIDED|95.0|-1.54|0.97|||MMRM|MMRM model included treatment, baseline score, assessment timepoint, and timepoint-by-treatment as explanatory variables, treated as fixed effects.|Difference was calculated as Monotherapy: SAGE-324 30 mg - placebo.|||0.97|-1.54|0.6549
72347250|NCT05173012|144216071|SUPERIORITY||LS Mean Difference|1.02|STANDARD_ERROR_OF_MEAN|0.7||0.1462|TWO_SIDED|95.0|-0.36|2.41|||MMRM|MMRM model included treatment, baseline score, assessment timepoint, and timepoint-by-treatment as explanatory variables, treated as fixed effects.|Difference was calculated as Monotherapy: SAGE-324 60 mg - placebo.|||2.41|-0.36|0.1462
72347251|NCT05173012|144216072|SUPERIORITY||LS Mean Difference|2.04|STANDARD_ERROR_OF_MEAN|1.326||0.1271|TWO_SIDED|95.0|0.59|4.67|||MMRM|MMRM model included treatment, baseline score, assessment timepoint, and timepoint-by-treatment as explanatory variables, treated as fixed effects.||||4.67|0.59|0.1271
72347252|NCT05173012|144216072|SUPERIORITY||LS Mean Difference|-0.78|STANDARD_ERROR_OF_MEAN|1.347||0.5642|TWO_SIDED|95.0|-3.45|1.89|||MMRM|MMRM model included treatment, baseline score, assessment timepoint, and timepoint-by-treatment as explanatory variables, treated as fixed effects.||||1.89|-3.45|0.5642
72347253|NCT05173012|144216072|SUPERIORITY||LS Mean Difference|1.01|STANDARD_ERROR_OF_MEAN|1.439||0.486|TWO_SIDED|95.0|-1.84|3.85|||MMRM|MMRM model included treatment, baseline score, assessment timepoint, and timepoint-by-treatment as explanatory variables, treated as fixed effects.||||3.85|-1.84|0.4860
72347254|NCT03668613|144216073|SUPERIORITY||Predicted Log-OR|4.862|||||TWO_SIDED|95.0|3.422|6.782|||Bayesian method using (MAP)|||Compared to historical placebo||6.782|3.422|
72347255|NCT03668613|144216073|SUPERIORITY||Predicted log-OR|4.836|||||TWO_SIDED|95.0|3.422|6.772|||Bayesian method using (MAP)|||Compared to historical placebo||6.772|3.422|
72347256|NCT03668613|144216074|SUPERIORITY||Predicted log -OR|4.292|||||TWO_SIDED|95.0|2.638|6.513|||Bayesian method using (MAP)|||Compared to historical placebo||6.513|2.638|
72347257|NCT03668613|144216074|SUPERIORITY||Predicted log-OR|4.606|||||TWO_SIDED|95.0|2.919|6.78|||Bayesian method using (MAP)|||Compared to historical placebo||6.780|2.919|
72347258|NCT03668613|144216075|SUPERIORITY||Predicted log-OR|4.367|||||TWO_SIDED|95.0|2.916|6.202|||Bayesian method using (MAP)|||||6.202|2.916|
72347259|NCT03668613|144216075|SUPERIORITY||Predicted log-OR|4.709|||||TWO_SIDED|95.0|3.201|6.58|||Bayesian method using (MAP)|||||6.580|3.201|
72347260|NCT00709618|144216085|SUPERIORITY_OR_OTHER||percentage of participants|41.0|||||TWO_SIDED|95.0|26.4|55.4|||||The estimated value respresents the percentage of participants with a complete response or a partial response.|||55.4|26.4|
72347261|NCT02920749|144216093|SUPERIORITY_OR_OTHER||||||<|0.05||||||The P value less than 0.05 was considered to be significant. With type I α = 5% and with type II (power) of 90%, we therefore needed 27 patients/group.|ANOVA|||Statistical analysis was carried out with SPSS version 21 for Windows (IBM Corporation) software. All data are expressed as means ± SD. Mann-Whitney test was performed to assess the differences between patient subgroups.||||<0.05
72347262|NCT02920749|144216094|SUPERIORITY_OR_OTHER||||||<|0.05||||||The P value less than 0.05 was considered to be significant. With type I α = 5% and with type II (power) of 90%, we therefore needed 27 patients/group.|ANOVA|||Statistical analysis was carried out with SPSS version 21 for Windows (IBM Corporation) software. All data are expressed as means ± SD. Mann-Whitney test was performed to assess the differences between patient subgroups.||||<0.05
72347263|NCT00880191|144216115|SUPERIORITY_OR_OTHER|||||||0.2344|TWO_SIDED||||||Fisher Exact|||Complete Responders by Arm - Days 2-6, the primary analysis utilizes Fisher's exact test to compare the percentage of complete responders in each group (dex/gabapentin vs. dex/placebo), with complete response being defined as no emetic episodes and no use of rescue therapy for days 2 through 6. If a patient does not complete the study or does not provide complete data, they will be assumed to be a non-responder.||||0.2344
72347264|NCT00880191|144216116|SUPERIORITY_OR_OTHER|||||||0.3694|TWO_SIDED||||||Fisher Exact|||The primary analysis described above was repeated using a slightly different alternate definition of complete response: no emetic episodes, no more than a mean of 2.5 on the nausea numeric analogue scale, and no rescue agents.||||0.3694
72347265|NCT03078855|144216122|SUPERIORITY||Hazard Ratio (HR)|1.28||||0.26|TWO_SIDED|95.0|0.83|1.98|||Regression, Cox||The EFS hazard ratio was adjusted for enrolling site, continuous age at randomization, and (via stratification) 3 randomization strata: non-follicular histology, follicular (FL) with low/intermediate FLIPI score and FL with high FLIPI score.|||1.98|0.83|0.26
72347266|NCT04124705|144216130|NON_INFERIORITY|If the lower limit of the 2-sided 95% confidence interval for stratified response rate difference was greater than the non-inferiority margin, the null hypothesis would be rejected and the noninferiority of Armour Thyroid to levothyroxine would be declared.|Stratified Response Rate Difference|-15.16|||||TWO_SIDED|95.0|-26.1|-4.23|||||The response rate difference (Armour Thyroid group minus Levothyroxine group) and the 95% confidence interval were calculated using the Mantel-Haenszel-weighted method with the age group (age \< 65 years or ≥ 65 years) as a stratification factor.|The null hypothesis was that Armour Thyroid would be inferior to levothyroxine for the primary efficacy endpoint, sustained TSH response. The non-inferiority hypothesis test was performed at a 1-sided 2.5% level of significance (equivalent to a two-sided 5% level of significance).||-4.23|-26.10|
72429056|NCT02404493|144368949|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.33||0.711|TWO_SIDED|95.0|-0.607|0.857||The significance level threshold level was 0.05.|ANCOVA|Change from baseline as response, baseline score as covariate and treatment as factor.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.857|-0.607|0.711
72347267|NCT04124705|144216131|NON_INFERIORITY|If the lower limit of the 2-sided 95% confidence interval for stratified response rate difference was greater than the non-inferiority margin, the null hypothesis would be rejected and the noninferiority of Armour Thyroid to levothyroxine would be declared.|Stratified Response Rate Difference|-10.52|||||TWO_SIDED|95.0|-18.65|-2.38|||||The response rate difference (Armour Thyroid group minus Levothyroxine group) and the 95% confidence interval were calculated using the Mantel-Haenszel-weighted method with the age group (age \< 65 years or ≥ 65 years) as a stratification factor.|The null hypothesis was that Armour Thyroid would be inferior to levothyroxine for titration TSH response. The non-inferiority hypothesis test was performed at a 1-sided 2.5% level of significance.||-2.38|-18.65|
72347268|NCT01973998|144216132|EQUIVALENCE|The primary outcome is time from randomization to a composite outcome of all cause re-hospitalization and all-cause mortality, whichever comes first. The primary analysis will be a log-ranked test and associated Kaplan-Meier plot, unadjusted for any covariates|Hazard Ratio (HR)|1.654|STANDARD_DEVIATION|0.4789|<|0.1|TWO_SIDED|10.0|1.175|2.133||Because this is a pilot study the intent is to see if there is a signal that would justify a larger clinical trial. Therefore the significance level has been set to 0.1 and the power has been set at 0.7.|Log Rank|||||2.133|1.175|<0.1
72347269|NCT01973998|144216132|SUPERIORITY||Hazard Ratio (HR)|1.654|STANDARD_DEVIATION|0.4789||0.1|TWO_SIDED|10.0|1.175|2.133|||Log Rank|||A total of 100 patients is required in a 2 treatment parallel-design study. There is a 70% probability that the study will detect a treatment difference at a 2-sided 10% significance level, if the true hazard ratio is 1.654. This is based on the assumption that the accrual period will be 36 months and the follow up period will be 6 months and the median time to event is 8 months. The total number of events will be 73.||2.133|1.175|0.1
72347270|NCT04146935|144216142|OTHER|Mixed model repeated measures||||||0.4147||||||Visit 1 (baseline) to visit 4 (peak)|Mixed Models Analysis|||||||0.4147
72347271|NCT04146935|144216143|OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||<.0001
72347272|NCT04146935|144216144|OTHER|Mixed model repeated measures||||||0.6957|||||||Mixed Models Analysis|||||||0.6957
72347273|NCT04146935|144216145|OTHER|||||||0.0092|||||||Mixed Models Analysis|||||||0.0092
72347274|NCT04146935|144216146|OTHER|Mixed model repeated measures||||||0.1383|||||||Mixed Models Analysis|||||||0.1383
72347275|NCT04146935|144216147|OTHER|mixed model repeated measures||||||0.0572|||||||Mixed Models Analysis|||||||0.0572
72347276|NCT04038567|144216148|SUPERIORITY||Mean Difference (Final Values)|0.03|||||TWO_SIDED|95.0|-1.14|1.2||||||Values are change in model-estimated means for therapist vs. app introduction. Intervention components are coded as follows: introduction method (therapist \[1\] vs app \[-1\]), dose (high \[1\] vs low \[-1\]), and symptom management (therapist \[1\] vs app \[-1\]).||1.20|-1.14|
72347277|NCT04038567|144216148|SUPERIORITY||Mean Difference (Final Values)|-1.22|||||TWO_SIDED|95.0|-2.39|-0.04||||||Values are change in model-estimated means for his vs. standard dose. Intervention components are coded as follows: introduction method (therapist \[1\] vs app \[-1\]), dose (high \[1\] vs low \[-1\]), and symptom management (therapist \[1\] vs app \[-1\]).||-0.04|-2.39|
72347278|NCT04038567|144216148|SUPERIORITY||Mean Difference (Final Values)|0.06|||||TWO_SIDED|95.0|-1.12|1.23||||||Values are change in model-estimated means for therapist vs. app response. Intervention components are coded as follows: introduction method (therapist \[1\] vs app \[-1\]), dose (high \[1\] vs low \[-1\]), and symptom management (therapist \[1\] vs app \[-1\]).||1.23|-1.12|
72347279|NCT04038567|144216149|SUPERIORITY||Mean Difference (Net)|-1.14|||||TWO_SIDED|95.0|-2.12|-0.16||||||Values are change in model-estimated means for therapist vs. app introduction. Intervention components are coded as follows: introduction method (therapist \[1\] vs app \[-1\]), dose (high \[1\] vs low \[-1\]), and symptom management (therapist \[1\] vs app \[-1\]).||-0.16|-2.12|
72347280|NCT04038567|144216149|SUPERIORITY||Mean Difference (Final Values)|-0.82|||||TWO_SIDED|95.0|-1.8|1.49||||||Values are change in model-estimated means for high vs. standard dose. Intervention components are coded as follows: introduction method (therapist \[1\] vs app \[-1\]), dose (high \[1\] vs low \[-1\]), and symptom management (therapist \[1\] vs app \[-1\]).||1.49|-1.80|
72347281|NCT04038567|144216149|SUPERIORITY||Mean Difference (Final Values)|0.51|||||TWO_SIDED|95.0|-0.48|1.49||||||Values are change in model-estimated means for therapist vs. app response. Intervention components are coded as follows: introduction method (therapist \[1\] vs app \[-1\]), dose (high \[1\] vs low \[-1\]), and symptom management (therapist \[1\] vs app \[-1\]).||1.49|-0.48|
72347282|NCT04038567|144216150|SUPERIORITY||Mean Difference (Final Values)|-0.32|||||TWO_SIDED|95.0|-1.66|1.01||||||Values are change in model-estimated means for therapist vs. app introduction. Intervention components are coded as follows: introduction method (therapist \[1\] vs app \[-1\]), dose (high \[1\] vs low \[-1\]), and symptom management (therapist \[1\] vs app \[-1\]).||1.01|-1.66|
72347283|NCT04038567|144216150|SUPERIORITY||Mean Difference (Final Values)|-1.47|||||TWO_SIDED|95.0|-2.81|-0.14||||||Values are change in model-estimated means for high vs. standard dose. Intervention components are coded as follows: introduction method (therapist \[1\] vs app \[-1\]), dose (high \[1\] vs low \[-1\]), and symptom management (therapist \[1\] vs app \[-1\]).||-0.14|-2.81|
72347284|NCT04038567|144216150|SUPERIORITY||Mean Difference (Final Values)|0.82|||||TWO_SIDED|95.0|-0.52|2.15||||||Values are change in model-estimated means for therapist vs. app response to symptoms. Intervention components are coded as follows: introduction method (therapist \[1\] vs app \[-1\]), dose (high \[1\] vs low \[-1\]), and symptom management (therapist \[1\] vs app \[-1\]).||2.15|-0.52|
72347285|NCT04038567|144216151|SUPERIORITY||Mean Difference (Final Values)|-0.16|||||TWO_SIDED|95.0|-1.23|0.91||||||||0.91|-1.23|
72429057|NCT02404493|144368950|SUPERIORITY_OR_OTHER|||||||0.006||||||The significance level threshold level was 0.05.|One sample t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||0.006
72347286|NCT04038567|144216151|SUPERIORITY||Mean Difference (Final Values)|-1.22|||||TWO_SIDED|95.0|-2.29|-0.15||||||||-0.15|-2.29|
72347287|NCT04038567|144216151|SUPERIORITY||Mean Difference (Final Values)|-0.7|||||TWO_SIDED|95.0|-1.77|0.37||||||||0.37|-1.77|
72347288|NCT04038567|144216152|SUPERIORITY||Mean Difference (Final Values)|-1.58|||||TWO_SIDED|95.0|-4.41|1.25||||||Values are change in model-estimated means for therapist vs. app introduction. Intervention components are coded as follows: introduction method (therapist \[1\] vs app \[-1\]), dose (high \[1\] vs low \[-1\]), and symptom management (therapist \[1\] vs app \[-1\]).||1.25|-4.41|
72347289|NCT04038567|144216152|SUPERIORITY||Mean Difference (Final Values)|-0.42|||||TWO_SIDED|95.0|-3.26|2.42||||||Values are change in model-estimated means for hig vs. standard dose. Intervention components are coded as follows: introduction method (therapist \[1\] vs app \[-1\]), dose (high \[1\] vs low \[-1\]), and symptom management (therapist \[1\] vs app \[-1\]).||2.42|-3.26|
72347290|NCT04038567|144216152|SUPERIORITY||Mean Difference (Final Values)|1.49|||||TWO_SIDED|95.0|-1.35|4.33||||||Values are change in model-estimated means for therapist vs. app response. Intervention components are coded as follows: introduction method (therapist \[1\] vs app \[-1\]), dose (high \[1\] vs low \[-1\]), and symptom management (therapist \[1\] vs app \[-1\]).||4.33|-1.35|
72347291|NCT04038567|144216157|SUPERIORITY||Mean Difference (Final Values)|0.58|||||TWO_SIDED|95.0|-0.62|1.78||||||Values are change in model-estimated means for therapist vs. app introduction. Intervention components are coded as follows: introduction method (therapist \[1\] vs app \[-1\]), dose (high \[1\] vs low \[-1\]), and symptom management (therapist \[1\] vs app \[-1\]).||1.78|-0.62|
72347292|NCT04038567|144216157|SUPERIORITY||Mean Difference (Final Values)|0.73|||||TWO_SIDED|95.0|-0.47|1.92||||||Values are change in model-estimated means for high vs. standard dose. Intervention components are coded as follows: introduction method (therapist \[1\] vs app \[-1\]), dose (high \[1\] vs low \[-1\]), and symptom management (therapist \[1\] vs app \[-1\]).||1.92|-0.47|
72347293|NCT04038567|144216157|SUPERIORITY||Mean Difference (Final Values)|0.19|||||TWO_SIDED|95.0|-1.0|1.39||||||Values are change in model-estimated means for therapist vs. app response. Intervention components are coded as follows: introduction method (therapist \[1\] vs app \[-1\]), dose (high \[1\] vs low \[-1\]), and symptom management (therapist \[1\] vs app \[-1\]).||1.39|-1.00|
72347294|NCT04038567|144216158|SUPERIORITY||Mean Difference (Final Values)|0.91|||||TWO_SIDED|95.0|-0.45|2.27||||||Values are change in model-estimated means for therapist vs. app introduction. Intervention components are coded as follows: introduction method (therapist \[1\] vs app \[-1\]), dose (high \[1\] vs low \[-1\]), and symptom management (therapist \[1\] vs app \[-1\]).||2.27|-0.45|
72347295|NCT04038567|144216158|SUPERIORITY||Mean Difference (Final Values)|0.02|||||TWO_SIDED|95.0|-1.33|1.38||||||Values are change in model-estimated means for high vs. standard dose. Intervention components are coded as follows: introduction method (therapist \[1\] vs app \[-1\]), dose (high \[1\] vs low \[-1\]), and symptom management (therapist \[1\] vs app \[-1\]).||1.38|-1.33|
72347296|NCT04038567|144216158|SUPERIORITY||Mean Difference (Final Values)|-0.36|||||TWO_SIDED|95.0|-1.72|0.99||||||Values are change in model-estimated means for therapist vs. app response. Intervention components are coded as follows: introduction method (therapist \[1\] vs app \[-1\]), dose (high \[1\] vs low \[-1\]), and symptom management (therapist \[1\] vs app \[-1\]).||0.99|-1.72|
72347297|NCT04038567|144216159|SUPERIORITY||Mean Difference (Final Values)|-0.5|||||TWO_SIDED|95.0|-1.3|0.3||||||Values are change in model-estimated means for therapist vs. app introduction. Intervention components are coded as follows: introduction method (therapist \[1\] vs app \[-1\]), dose (high \[1\] vs low \[-1\]), and symptom management (therapist \[1\] vs app \[-1\]).||0.30|-1.30|
72347298|NCT04038567|144216159|SUPERIORITY||Mean Difference (Final Values)|-0.53|||||TWO_SIDED|95.0|-1.33|0.27||||||Values are change in model-estimated means for high vs. standard dose. Intervention components are coded as follows: introduction method (therapist \[1\] vs app \[-1\]), dose (high \[1\] vs low \[-1\]), and symptom management (therapist \[1\] vs app \[-1\]).||0.27|-1.33|
72347299|NCT04038567|144216159|SUPERIORITY||Mean Difference (Final Values)|0.25|||||TWO_SIDED|95.0|-0.55|1.05||||||Values are change in model-estimated means for therapist vs. app response. Intervention components are coded as follows: introduction method (therapist \[1\] vs app \[-1\]), dose (high \[1\] vs low \[-1\]), and symptom management (therapist \[1\] vs app \[-1\]).||1.05|-.55|
72347300|NCT04038567|144216160|SUPERIORITY||Mean Difference (Final Values)|-0.5|||||TWO_SIDED|95.0|-1.41|0.41||||||||0.41|-1.41|
72347301|NCT04038567|144216160|SUPERIORITY||Mean Difference (Final Values)|-0.36|||||TWO_SIDED|95.0|-1.27|0.55||||||||0.55|-1.27|
72347302|NCT04038567|144216160|SUPERIORITY||Mean Difference (Final Values)|0.51|||||TWO_SIDED|95.0|-0.4|1.42||||||Values are change in model-estimated means for therapist vs. app response. Intervention components are coded as follows: introduction method (therapist \[1\] vs app \[-1\]), dose (high \[1\] vs low \[-1\]), and symptom management (therapist \[1\] vs app \[-1\]).||1.42|-0.40|
72347303|NCT04038567|144216161|SUPERIORITY||Mean Difference (Final Values)|2.33|||||TWO_SIDED|95.0|-3.25|7.91||||||Values are change in model-estimated means for therapist vs. app introduction. Intervention components are coded as follows: introduction method (therapist \[1\] vs app \[-1\]), dose (high \[1\] vs low \[-1\]), and symptom management (therapist \[1\] vs app \[-1\]).||7.91|-3.25|
72347304|NCT04038567|144216161|SUPERIORITY||Mean Difference (Final Values)|4.82|||||TWO_SIDED|95.0|-0.76|10.4||||||Values are change in model-estimated means for high vs. standard dose. Intervention components are coded as follows: introduction method (therapist \[1\] vs app \[-1\]), dose (high \[1\] vs low \[-1\]), and symptom management (therapist \[1\] vs app \[-1\]).||10.40|-0.76|
72429058|NCT02404493|144368950|SUPERIORITY_OR_OTHER|||||||0.012||||||The significance level threshold level was 0.05.|One sample t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||0.012
72347305|NCT04038567|144216161|SUPERIORITY||Mean Difference (Final Values)|-0.02|||||TWO_SIDED|95.0|-5.6|5.56||||||Values are change in model-estimated means for therapist vs. app response. Intervention components are coded as follows: introduction method (therapist \[1\] vs app \[-1\]), dose (high \[1\] vs low \[-1\]), and symptom management (therapist \[1\] vs app \[-1\]).||5.56|-5.60|
72347306|NCT04038567|144216162|SUPERIORITY||Mean Difference (Final Values)|3.18|||||TWO_SIDED|95.0|-3.01|9.37||||||Values are change in model-estimated means for therapist vs. app introduction. Intervention components are coded as follows: introduction method (therapist \[1\] vs app \[-1\]), dose (high \[1\] vs low \[-1\]), and symptom management (therapist \[1\] vs app \[-1\]).||9.37|-3.01|
72347307|NCT04038567|144216162|SUPERIORITY||Mean Difference (Final Values)|1.28|||||TWO_SIDED|95.0|-4.92|7.47||||||Values are change in model-estimated means for high vs. standard dose. Intervention components are coded as follows: introduction method (therapist \[1\] vs app \[-1\]), dose (high \[1\] vs low \[-1\]), and symptom management (therapist \[1\] vs app \[-1\]).||7.47|-4.92|
72347308|NCT04038567|144216162|SUPERIORITY||Mean Difference (Final Values)|0.11|||||TWO_SIDED|95.0|-6.09|6.3||||||Values are change in model-estimated means for therapist vs. app response. Intervention components are coded as follows: introduction method (therapist \[1\] vs app \[-1\]), dose (high \[1\] vs low \[-1\]), and symptom management (therapist \[1\] vs app \[-1\]).||6.30|-6.09|
72347309|NCT04038567|144216169|SUPERIORITY||Mean Difference (Final Values)|-2.7|||||TWO_SIDED|95.0|-5.26|-0.13||||||Values are change in model-estimated means for therapist vs. app introduction. Intervention components are coded as follows: introduction method (therapist \[1\] vs app \[-1\]), dose (high \[1\] vs low \[-1\]), and symptom management (therapist \[1\] vs app \[-1\]).||-0.13|-5.26|
72347310|NCT04038567|144216169|SUPERIORITY||Mean Difference (Final Values)|-1.89|||||TWO_SIDED|95.0|-4.46|0.67||||||Values are change in model-estimated means for high vs. standard dose. Intervention components are coded as follows: introduction method (therapist \[1\] vs app \[-1\]), dose (high \[1\] vs low \[-1\]), and symptom management (therapist \[1\] vs app \[-1\]).||0.67|-4.46|
72347311|NCT04038567|144216169|SUPERIORITY||Mean Difference (Final Values)|-0.74|||||TWO_SIDED|95.0|-3.31|1.83||||||Values are change in model-estimated means for therapist vs. app response. Intervention components are coded as follows: introduction method (therapist \[1\] vs app \[-1\]), dose (high \[1\] vs low \[-1\]), and symptom management (therapist \[1\] vs app \[-1\]).||1.83|-3.31|
72347312|NCT01278797|144216190|SUPERIORITY_OR_OTHER||Test/Reference ratio of geometric means|94.51||||0.005||90.0|91.6|97.51|||ANOVA|ANOVA was applied to log-transformed AUC72 and Included treatment, sequence, period and subject-within-sequence effects.||Telmisartan/Amlodipine 80 mg/10 mg versus Telmisartan 80 mg + Amlodipine 10 mg The two formulations are shown to be bioequivalent since the 90% confidence interval of the test to reference ratio is entirely contained within the 80-125% bioequivalence range.||97.51|91.60|0.005
72347313|NCT01278797|144216191|SUPERIORITY_OR_OTHER||Test/Reference ratio of geometric means|94.1||||0.0093||90.0|90.7|97.63|||ANOVA|ANOVA was applied to log-transformed CMAX and Included treatment, sequence, period and subject-within-sequence effects.||Telmisartan/Amlodipine 80 mg/10 mg versus Telmisartan 80 mg + Amlodipine 10 mg The two formulations are shown to be bioequivalent since the 90% confidence interval of the test to reference ratio is entirely contained within the 80-125% bioequivalence range.||97.63|90.70|0.0093
72347314|NCT01278797|144216192|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.58||||0.153|||||||ANOVA|ANOVA was applied to TMAX and Included treatment, sequence, period and subject-within-sequence effects.||Telmisartan/Amlodipine 80 mg/10 mg versus Telmisartan 80 mg + Amlodipine 10 mg||||0.153
72347315|NCT01736618|144216195|OTHER||Kaplan-Meier|92.9|||||ONE_SIDED|95.0|91.4|||||||"Ho: The Type I Complication Free Rate at 60 months (p1) does not exceed the performance goal of 85.0%.~Ho: p1 ≤ 85.0% Ha: The Type I Complication Free Rate at 60 months (p1) does exceed the performance goal of 85.0%.~Ha: p1 \> 85.0% The null hypothesis will be rejected if the lower one-sided 95% confidence bound of the proportional means model estimate, using the Peto method for standard error, exceeds the performance goal of 85.0%."|||91.4|
72347316|NCT01736618|144216196|OTHER||Clopper-Pearson exact confidence bound|98.6|||||ONE_SIDED|95.0|97.4|||||||"Ho: Overall Shock Effectiveness in Converting Spontaneous Discrete Episodes of VT/VF through 60 months (p1) does not exceed the performance goal of 94.0%.~Ho: p1 ≤ 94.0% Ha: Overall Shock Effectiveness in Converting Spontaneous Discrete Episodes of VT/VF through 60 months (p1) does exceed the performance goal of 94.0%.~Ha: p1 \>94.0% The null hypothesis will be rejected if the lower one-sided 95% exact confidence bound of the estimate exceeds the performance goal of 94.0%."|||97.4|
72347317|NCT01736618|144216197|OTHER||Kaplan-Meier|99.2|||||ONE_SIDED|95.0|98.8|||||||"Ho: The Electrode-Related Complication Free Rate at 60 months (p1) does not exceed the performance goal of 92.5%.~Ho: p1 ≤ 92.5% Ha: The Electrode-Related Complication Free Rate at 60 months (p1) does exceed the performance goal of 92.5%.~Ha: p1 \> 92.5% The null hypothesis will be rejected if the lower one-sided 95% confidence bound of the proportional means model estimate, using the Peto method for standard error, exceeds the performance goal of 92.5%."|||98.8|
72347318|NCT01736618|144216198|OTHER||Clopper-Pearson exact confidence bound|94.4|||||ONE_SIDED|95.0|93.5|||||||"Ho: The 1st Shock Effectiveness in Converting Induced (Acute) \& Spontaneous Discrete VT/VF Episodes to 60 months (p1) does not exceed the performance goal of 84.0%.~Ho: p1 ≤ 84.0% Ha: The 1st Shock Effectiveness in Converting Induced (Acute) \& Spontaneous Discrete VT/VF Episodes to 60 months (p1) does exceed the performance goal of 84.0%.~Ha: p1 \>84.0% The null hypothesis will be rejected if lower one-sided 95% exact confidence bound of the estimate exceeds the performance goal of 84.0%."|||93.5|
72347319|NCT03637517|144216207|EQUIVALENCE|2 comparisons performed: Reg. B vs. Reg. A, \& Reg.C vs. Reg. B. Bioavailability of each test reg. relative to that of each reference reg. assessed via 90% CI. CI obtained by taking the antilog of the upper and lower limits of CI for the difference of the least squares means on the log scale within the ANOVA framework model. Bioequivalence between a test reg. and the reference reg. is concluded if the 90% CI from the analyses of the natural log of Cmax and AUC are within 0.80 to 1.25 range.|Least Squares Means Log scale|0.926||||0.4847|TWO_SIDED|90.0|0.771|1.113|||ANOVA|||||1.113|0.771|0.4847
72347320|NCT03637517|144216207|EQUIVALENCE|2 comparisons performed: Reg. B vs. Reg. A, \& Reg.C vs. Reg. B. Bioavailability of each test reg. relative to that of each reference reg. assessed via 90% CI. CI obtained by taking the antilog of the upper and lower limits of CI for the difference of the least squares means on the log scale within the ANOVA framework model. Bioequivalence between a test reg. and the reference reg. is concluded if the 90% CI from the analyses of the natural log of Cmax and AUC are within 0.80 to 1.25 range.|Least Squares Means Log scale|0.79||||0.037|TWO_SIDED|90.0|0.658|0.95|||ANOVA|||||0.950|0.658|0.0370
72347321|NCT03637517|144216208|EQUIVALENCE|Bioavailability of each test reg. relative to each reference reg will be assessed via 90% CI obtained from the analyses of the natural logs of Cmax and AUC. These CI are obtained by taking the antilog of the upper \& lower CI for the difference of the least squares means on the log scale within the ANOVA model. Bioequivalence between a test reg and the respective reference reg will be concluded if the 90% CI from the analyses of the natural log of Cmax and AUC are within the 0.80 to 1.25 range.|Sum of squares|0.899||||0.1135|TWO_SIDED|90.0|0.805|1.004|||ANOVA|||||1.004|0.805|0.1135
72347322|NCT03637517|144216208|EQUIVALENCE|Bioavailability of each test reg. relative to each reference reg will be assessed via 90% CI obtained from the analyses of the natural logs of Cmax and AUC. These CI are obtained by taking the antilog of the upper \& lower CI for the difference of the least squares means on the log scale within the ANOVA model. Bioequivalence between a test reg and the respective reference reg will be concluded if the 90% CI from the analyses of the natural log of Cmax and AUC are within the 0.80 to 1.25 range.|Sum of squares|1.175||||0.0192|TWO_SIDED|90.0|1.051|1.312|||ANOVA|||||1.312|1.051|0.0192
72429059|NCT02404493|144368950|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.194||0.932|TWO_SIDED|95.0|-0.391|0.424||The significance level threshold level was 0.05.|ANCOVA|Change from baseline as response, baseline score as covariate and treatment as factor.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.424|-0.391|0.932
72347323|NCT03637517|144216209|EQUIVALENCE|Bioavailability of each test reg. relative to each reference reg will be assessed via 90% CI obtained from the analyses of the natural logs of Cmax and AUC. These CI are obtained by taking the antilog of the upper \& lower CI for the difference of the least squares means on the log scale within the ANOVA model. Bioequivalence between a test reg and the respective reference reg will be concluded if the 90% CI from the analyses of the natural log of Cmax and AUC are within the 0.80 to 1.25 range.|Sum of squares|0.898||||0.1759|TWO_SIDED|90.0|0.787|1.024|||ANOVA||Regimen B to A|||1.024|0.787|0.1759
72347324|NCT03637517|144216209|EQUIVALENCE|Bioavailability of each test reg. relative to each reference reg will be assessed via 90% CI obtained from the analyses of the natural logs of Cmax and AUC. These CI are obtained by taking the antilog of the upper \& lower CI for the difference of the least squares means on the log scale within the ANOVA model. Bioequivalence between a test reg and the respective reference reg will be concluded if the 90% CI from the analyses of the natural log of Cmax and AUC are within the 0.80 to 1.25 range.|Sum of squares|1.172||||0.0496|TWO_SIDED|90.0|1.027|1.338|||ANOVA||Regimen C to B|||1.338|1.027|0.0496
72347325|NCT03637517|144216210|EQUIVALENCE|Bioavailability of each test reg. relative to each reference reg will be assessed via 90% CI obtained from the analyses of the natural logs of Cmax and AUC. These CI are obtained by taking the antilog of the upper \& lower CI for the difference of the least squares means on the log scale within the ANOVA model. Bioequivalence between a test reg and the respective reference reg will be concluded if the 90% CI from the analyses of the natural log of Cmax and AUC are within the 0.80 to 1.25 range.|Least Squares Means|-0.2857|STANDARD_ERROR_OF_MEAN|1.866979|||TWO_SIDED|90.0|-3.4313|2.8599||||||||2.8599|-3.4313|
72347326|NCT03637517|144216210|EQUIVALENCE|Bioavailability of each test reg. relative to each reference reg will be assessed via 90% CI obtained from the analyses of the natural logs of Cmax and AUC. These CI are obtained by taking the antilog of the upper \& lower CI for the difference of the least squares means on the log scale within the ANOVA model. Bioequivalence between a test reg and the respective reference reg will be concluded if the 90% CI from the analyses of the natural log of Cmax and AUC are within the 0.80 to 1.25 range.|Least Squares Means|9.3571|STANDARD_ERROR_OF_MEAN|1.866979|||TWO_SIDED|90.0|6.2115|12.5028|||||Regimen C to B|||12.5028|6.2115|
72347327|NCT03637517|144216212|EQUIVALENCE|Bioequivalence between a test regimen and the respective reference regimen will be concluded if the 90% confidence intervals from the analyses of the natural logarithms of Cmax and AUC are within the 0.80 to 1.25 range.|Sum of squares|0.866||||0.1745|TWO_SIDED|90.0|0.727|1.032|||ANOVA|||(ANOVA) will be performed for Tmax, the terminal phase elimination rate constant β, and the natural logarithms of Cmax, AUCt, AUC168, AUCinf, and C168. The model will include the effects for regimen. For the tests on regimen effects, the denominator sum of squares will be the residual sum of squares for error. Within the ANOVA modeling framework, the test regimen will be compared to the respective reference regimen by a test with a significance level of 0.05.||1.032|0.727|0.1745
72347328|NCT03637517|144216212|EQUIVALENCE|Bioequivalence between a test regimen and the respective reference regimen will be concluded if the 90% confidence intervals from the analyses of the natural logarithms of Cmax and AUC are within the 0.80 to 1.25 range.|Sum of squares|1.185||||0.1105|TWO_SIDED|90.0|0.995|1.411||For tests on regimen effects, the denominator sum of squares is the residual sum of squares for error. Within the ANOVA modeling framework, the test regimen is compared to the respective reference regimen by a test with a significance level of 0.05.|ANOVA|||||1.411|0.995|0.1105
72347329|NCT03637517|144216213|EQUIVALENCE|Bioequivalence between a test regimen and the respective reference regimen will be concluded if the 90% confidence intervals from the analyses of the natural logarithms of Cmax and AUC are within the 0.80 to 1.25 range.|LEAST SQUARES MEANS FOR LOGARITHMS.|0.901||||0.31|TWO_SIDED|90.0|0.759|1.069|||ANOVA|||||1.069|0.759|0.3100
72347330|NCT03637517|144216213|EQUIVALENCE|Bioequivalence between a test regimen and the respective reference regimen will be concluded if the 90% confidence intervals from the analyses of the natural logarithms of Cmax and AUC are within the 0.80 to 1.25 range.|LEAST SQUARES MEANS FOR LOGARITHMS.|1.156||||0.1619|TWO_SIDED|90.0|0.974|1.371|||ANOVA|||||1.371|0.974|0.1619
72347331|NCT02714283|144216218|SUPERIORITY||Hazard Ratio (HR)|0.77||||0.19|TWO_SIDED|95.0|0.51|1.14|||Regression, Cox|Adjusted for propensity score decile, oral corticosteroid use.|ICS (numerator) compared to macrolide monotherapy (denominator)|Due to the small sample size in the macrolide monotherapy group, for this outcome, the results are considered exploratory/descriptive only.||1.14|0.51|0.19
72347332|NCT02714283|144216219|SUPERIORITY||Hazard Ratio (HR)|1.39|||<|0.0001|TWO_SIDED|95.0|1.23|1.57|||Regression, Cox|Adjusted for propensity score decile, oral corticosteroid use, and NTM history.|ICS (numerator) compared to macrolide monotherapy (denominator)|||1.57|1.23|<0.0001
72347333|NCT02714283|144216220|SUPERIORITY||Hazard Ratio (HR)|0.86||||0.21|TWO_SIDED|95.0|0.67|1.09|||Regression, Cox|Adjusted for propensity score decile, oral corticosteroid use, and NTM history.|ICS (numerator) compared to macrolide monotherapy (denominator)|||1.09|0.67|0.21
72347334|NCT02714283|144216221|SUPERIORITY||Hazard Ratio (HR)|0.73|||<|0.0001|TWO_SIDED|95.0|0.64|0.82|||Regression, Cox|Adjusted for propensity score decile, oral corticosteroid use, and NTM history|ICS (numerator) compared to macrolide monotherapy (denominator)|||0.82|0.64|<0.0001
72347335|NCT02714283|144216222|SUPERIORITY||Hazard Ratio (HR)|1.02||||0.87|TWO_SIDED|95.0|0.8|1.32|||Regression, Cox|Adjusted for propensity score decile, oral corticosteroid use, and NTM history|ICS (numerator) compared to macrolide monotherapy (denominator)|||1.32|0.80|0.87
72347336|NCT02714283|144216223|SUPERIORITY||Hazard Ratio (HR)|0.9||||0.23|TWO_SIDED|95.0|0.76|1.07|||Regression, Cox|Adjusted for propensity score decile, oral corticosteroid use, and NTM history.|ICS (numerator) compared to macrolide monotherapy (denominator)|||1.07|0.76|0.23
72347337|NCT02714283|144216224|SUPERIORITY||Hazard Ratio (HR)|1.09||||0.2|TWO_SIDED|95.0|0.96|1.25|||Regression, Cox|Adjusted for propensity score decile, oral corticosteroid use, and NTM history.|ICS (numerator) compared to macrolide monotherapy (denominator)|||1.25|0.96|0.20
72347338|NCT02714283|144216225|SUPERIORITY||Hazard Ratio (HR)|1.15|||<|0.0001|TWO_SIDED|95.0|1.08|1.21|||Regression, Cox|Adjusted for propensity score decile, oral corticosteroid use, and NTM history|ICS (numerator) compared to macrolide monotherapy (denominator)|||1.21|1.08|<0.0001
72347339|NCT02714283|144216226|SUPERIORITY||Hazard Ratio (HR)|1.0||||0.99|TWO_SIDED|95.0|0.66|1.51|||Regression, Cox|Adjusted for propensity score decile, oral corticosteroid use, and NTM history|ICS (numerator) compared to macrolide monotherapy (denominator)|||1.51|0.66|0.99
72429060|NCT02404493|144368951|SUPERIORITY_OR_OTHER|||||||0.003||||||The significance level threshold level was 0.05.|One sample t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||0.003
72429061|NCT02404493|144368951|SUPERIORITY_OR_OTHER||||||<|0.001||||||The significance level threshold level was 0.05.|One sample t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||<0.001
72347340|NCT02714283|144216227|SUPERIORITY||Hazard Ratio (HR)|1.15||||0.0005|TWO_SIDED|95.0|1.07|1.25|||Regression, Cox|Adjusted for propensity score decile, oral corticosteroid use, and NTM history|ICS (numerator) compared to macrolide monotherapy (denominator)|||1.25|1.07|0.0005
72347341|NCT00620113|144216228|SUPERIORITY_OR_OTHER||Difference in LS Means|5.4|||<|0.001|TWO_SIDED|95.0|4.16|6.64||The stepwise linear trend test adjusted for multiplicity within the family of comparisons of active doses with placebo and preserved the Type I error rate. P-value is for Placebo through Odanacatib 50 mg dose.|ANCOVA|||Analysis for percent change from baseline to Week 52 in BMD was performed using a stepwise linear contrast test based on an analysis of covariance (ANCOVA) model with terms for treatment and study center. Treatment effect was assessed by Least-Squares means (LS mean) and the associated 95% confidence intervals. Estimated difference from placebo = odanacatib dose minus placebo dose. Positive mean treatment differences were in favor of odanacatib.||6.64|4.16|<0.001
72347342|NCT00620113|144216228|SUPERIORITY_OR_OTHER||Difference in LS Means|5.12|||<|0.001|TWO_SIDED|95.0|3.9|6.35||The stepwise linear trend test adjusted for multiplicity within the family of comparisons of active doses with placebo and preserved the Type I error rate. P-value is for Placebo through Odanacatib 25 mg dose.|ANCOVA|||Analysis for percent change from baseline to Week 52 in BMD was performed using a stepwise linear contrast test based on an ANCOVA model with terms for treatment and study center. Treatment effect was assessed by LS mean and the associated 95% confidence intervals. Estimated difference from placebo = odanacatib dose minus placebo dose. Positive mean treatment differences were in favor of odanacatib.||6.35|3.90|<0.001
72347343|NCT00620113|144216228|SUPERIORITY_OR_OTHER||Difference in LS Means|3.54|||<|0.001|TWO_SIDED|95.0|2.33|4.75||The stepwise linear trend test adjusted for multiplicity within the family of comparisons of active doses with placebo and preserved the Type I error rate. P-value is for Placebo through Odanacatib 10 mg dose.|ANCOVA|||Analysis for percent change from baseline to Week 52 in BMD was performed using a stepwise linear contrast test based on an ANCOVA model with terms for treatment and study center. Treatment effect was assessed by LS mean and the associated 95% confidence intervals. Estimated difference from placebo = odanacatib dose minus placebo dose. Positive mean treatment differences were in favor of odanacatib.||4.75|2.33|<0.001
72347344|NCT00620113|144216229|SUPERIORITY_OR_OTHER||Difference in LS Means|3.06|||<|0.001|TWO_SIDED|95.0|2.14|3.98||The stepwise linear trend test adjusted for multiplicity within the family of comparisons of active doses with placebo and preserved the Type I error rate. P-value is for Placebo through Odanacatib 50 mg dose.|ANCOVA|||Analysis for percent change from baseline to Week 52 in BMD was performed using a stepwise linear contrast test based on an ANCOVA model with terms for treatment and study center. Treatment effect was assessed by LS mean and the associated 95% confidence intervals. Estimated difference from placebo = odanacatib dose minus placebo dose. Positive mean treatment differences were in favor of odanacatib.||3.98|2.14|<0.001
72347345|NCT00620113|144216229|SUPERIORITY_OR_OTHER||Difference in LS Means|2.2|||<|0.001|TWO_SIDED|95.0|1.29|3.12||The stepwise linear trend test adjusted for multiplicity within the family of comparisons of active doses with placebo and preserved the Type I error rate. P-value is for Placebo through Odanacatib 25 mg dose.|ANCOVA|||Analysis for percent change from baseline to Week 52 in BMD was performed using a stepwise linear contrast test based on an ANCOVA model with terms for treatment and study center. Treatment effect was assessed by LS mean and the associated 95% confidence intervals. Estimated difference from placebo = odanacatib dose minus placebo dose. Positive mean treatment differences were in favor of odanacatib.||3.12|1.29|<0.001
72347346|NCT00620113|144216229|SUPERIORITY_OR_OTHER||Difference in LS Means|1.67|||<|0.001|TWO_SIDED|95.0|0.77|2.57||The stepwise linear trend test adjusted for multiplicity within the family of comparisons of active doses with placebo and preserved the Type I error rate. P-value is for Placebo through Odanacatib 10 mg dose.|ANCOVA|||Analysis for percent change from baseline to Week 52 in BMD was performed using a stepwise linear contrast test based on an ANCOVA model with terms for treatment and study center. Treatment effect was assessed by LS mean and the associated 95% confidence intervals. Estimated difference from placebo = odanacatib dose minus placebo dose. Positive mean treatment differences were in favor of odanacatib.||2.57|0.77|<0.001
72347347|NCT00620113|144216232|SUPERIORITY_OR_OTHER||Difference in LS Means|3.08|||<|0.001|TWO_SIDED|95.0|1.85|4.31||The stepwise linear trend test adjusted for multiplicity within the family of comparisons of active doses with placebo and preserved the Type I error rate. P-value is for Placebo through Odanacatib 50 mg dose.|ANCOVA|||Analysis for percent change from baseline to Week 52 in BMD was performed using a stepwise linear contrast test based on an ANCOVA model with terms for treatment and study center. Treatment effect was assessed by LS mean and the associated 95% confidence intervals. Estimated difference from placebo = odanacatib dose minus placebo dose. Positive mean treatment differences were in favor of odanacatib.||4.31|1.85|<0.001
72347348|NCT00620113|144216232|SUPERIORITY_OR_OTHER||Difference in LS Means|1.86||||0.003|TWO_SIDED|95.0|0.64|3.08||The stepwise linear trend test adjusted for multiplicity within the family of comparisons of active doses with placebo and preserved the Type I error rate. P-value is for Placebo through Odanacatib 25 mg dose.|ANCOVA|||Analysis for percent change from baseline to Week 52 in BMD was performed using a stepwise linear contrast test based on an ANCOVA model with terms for treatment and study center. Treatment effect was assessed by LS mean and the associated 95% confidence intervals. Estimated difference from placebo = odanacatib dose minus placebo dose. Positive mean treatment differences were in favor of odanacatib.||3.08|0.64|0.003
72370166|NCT00838513|144250670|SUPERIORITY_OR_OTHER||LS mean change from baseline|6.75||||0.5423|TWO_SIDED|95.0|-15.73|29.23|||ANOVA|Change from baseline were analyzed using a repeated measurement ANOVA model with time and baseline as fixed effects and subject as a random effect.||All analyses were based on the pooled data from the two protocols: C08-003A (adult) and C08-003B (adolescent), a similar protocol, for patients \<18 years||29.23|-15.73|0.5423
72370167|NCT00838513|144250671|SUPERIORITY_OR_OTHER||Percent of platelet count normalization|90.0|||||TWO_SIDED|95.0|68.0|99.0||||||All analyses were based on the pooled data from the two protocols: C08-003A (adult) and C08-003B (adolescent), a similar protocol, for patients \<18 years||99|68|
72370168|NCT00838513|144250672|SUPERIORITY_OR_OTHER||Percent of TMA event-free responders|95.0|||||TWO_SIDED|95.0|75.0|100.0||||||All analyses were based on the pooled data from the two protocols: C08-003A (adult) and C08-003B (adolescent), a similar protocol, for patients \<18 years with aHUS.||100|75|
72347349|NCT00620113|144216232|SUPERIORITY_OR_OTHER||Difference in LS Means|2.23|||<|0.001|TWO_SIDED|95.0|1.03|3.43||The stepwise linear trend test adjusted for multiplicity within the family of comparisons of active doses with placebo and preserved the Type I error rate. P-value is for Placebo through Odanacatib 10 mg dose.|ANCOVA|||Analysis for percent change from baseline to Week 52 in BMD was performed using a stepwise linear contrast test based on an ANCOVA model with terms for treatment and study center. Treatment effect was assessed by LS mean and the associated 95% confidence intervals. Estimated difference from placebo = odanacatib dose minus placebo dose. Positive mean treatment differences were in favor of odanacatib.||3.43|1.03|<0.001
72347350|NCT00620113|144216233|SUPERIORITY_OR_OTHER||Difference in LS Means|4.66|||<|0.001|TWO_SIDED|95.0|3.18|6.14||The stepwise linear trend test adjusted for multiplicity within the family of comparisons of active doses with placebo and preserved the Type I error rate. P-value is for Placebo through Odanacatib 50 mg dose.|ANCOVA|||Analysis for percent change from baseline to Week 52 in BMD was performed using a stepwise linear contrast test based on an ANCOVA model with terms for treatment and study center. Treatment effect was assessed by LS mean and the associated 95% confidence intervals. Estimated difference from placebo = odanacatib dose minus placebo dose. Positive mean treatment differences were in favor of odanacatib.||6.14|3.18|<0.001
72347351|NCT00620113|144216233|SUPERIORITY_OR_OTHER||Difference in LS Means|3.84|||<|0.001|TWO_SIDED|95.0|2.37|5.3||The stepwise linear trend test adjusted for multiplicity within the family of comparisons of active doses with placebo and preserved the Type I error rate. P-value is for Placebo through Odanacatib 25 mg dose.|ANCOVA|||Analysis for percent change from baseline to Week 52 in BMD was performed using a stepwise linear contrast test based on an ANCOVA model with terms for treatment and study center. Treatment effect was assessed by LS mean and the associated 95% confidence intervals. Estimated difference from placebo = odanacatib dose minus placebo dose. Positive mean treatment differences were in favor of odanacatib.||5.30|2.37|<0.001
72347352|NCT00620113|144216233|SUPERIORITY_OR_OTHER||Difference in LS Means|2.43||||0.002|TWO_SIDED|95.0|0.99|3.88||The stepwise linear trend test adjusted for multiplicity within the family of comparisons of active doses with placebo and preserved the Type I error rate. P-value is for Placebo through Odanacatib 10 mg dose.|ANCOVA|||Analysis for percent change from baseline to Week 52 in BMD was performed using a stepwise linear contrast test based on an ANCOVA model with terms for treatment and study center. Treatment effect was assessed by LS mean and the associated 95% confidence intervals. Estimated difference from placebo = odanacatib dose minus placebo dose. Positive mean treatment differences were in favor of odanacatib.||3.88|0.99|0.002
72347353|NCT00620113|144216234|SUPERIORITY_OR_OTHER||Difference in LS Means|-50.64|||<|0.001|TWO_SIDED|95.0|-66.43|-34.84||The stepwise linear trend test adjusted for multiplicity within the family of comparisons of active doses with placebo and preserved the Type I error rate. P-value is for Placebo through Odanacatib 50 mg dose.|ANCOVA|||The log-transformed fraction from baseline in biomarker levels was analyzed using an ANCOVA model with terms for treatment and study center, using a stepwise linear contrast test based on the ANCOVA model. The geometric mean percent change from baseline (back-transformation from the mean log-transformed fraction) and the associated 95% confidence intervals were presented.||-34.84|-66.43|<0.001
72347354|NCT00620113|144216234|SUPERIORITY_OR_OTHER||Difference in LS Means|-44.32|||<|0.001|TWO_SIDED|95.0|-60.42|-28.21||The stepwise linear trend test adjusted for multiplicity within the family of comparisons of active doses with placebo and preserved the Type I error rate. P-value is for Placebo through Odanacatib 25 mg dose.|ANCOVA|||The log-transformed fraction from baseline in biomarker levels was analyzed using an ANCOVA model with terms for treatment and study center, using a stepwise linear contrast test based on the ANCOVA model. The geometric mean percent change from baseline (back-transformation from the mean log-transformed fraction) and the associated 95% confidence intervals were presented.||-28.21|-60.42|<0.001
72347355|NCT00620113|144216234|SUPERIORITY_OR_OTHER||Difference in LS Means|-35.75|||<|0.001|TWO_SIDED|95.0|-52.33|-19.16||The stepwise linear trend test adjusted for multiplicity within the family of comparisons of active doses with placebo and preserved the Type I error rate. P-value is for Placebo through Odanacatib 10 mg dose.|ANCOVA|||The log-transformed fraction from baseline in biomarker levels was analyzed using an ANCOVA model with terms for treatment and study center, using a stepwise linear contrast test based on the ANCOVA model. The geometric mean percent change from baseline (back-transformation from the mean log-transformed fraction) and the associated 95% confidence intervals were presented.||-19.16|-52.33|<0.001
72347356|NCT00620113|144216235|SUPERIORITY_OR_OTHER||Difference in LS Means|-60.42|||<|0.001|TWO_SIDED|95.0|-85.7|-35.13||The stepwise linear trend test adjusted for multiplicity within the family of comparisons of active doses with placebo and preserved the Type I error rate. P-value is for Placebo through Odanacatib 50 mg dose.|ANCOVA|||The log-transformed fraction from baseline in biomarker levels was analyzed using an ANCOVA model with terms for treatment and study center, using a stepwise linear contrast test based on the ANCOVA model. The geometric mean percent change from baseline (back-transformation from the mean log-transformed fraction) and the associated 95% confidence intervals were presented.||-35.13|-85.70|<0.001
72347357|NCT00620113|144216235|SUPERIORITY_OR_OTHER||Difference in LS Means|-60.7|||<|0.001|TWO_SIDED|95.0|-85.91|-35.49||The stepwise linear trend test adjusted for multiplicity within the family of comparisons of active doses with placebo and preserved the Type I error rate. P-value is for Placebo through Odanacatib 25 mg dose.|ANCOVA|||The log-transformed fraction from baseline in biomarker levels was analyzed using an ANCOVA model with terms for treatment and study center, using a stepwise linear contrast test based on the ANCOVA model. The geometric mean percent change from baseline (back-transformation from the mean log-transformed fraction) and the associated 95% confidence intervals were presented.||-35.49|-85.91|<0.001
72347358|NCT00620113|144216235|SUPERIORITY_OR_OTHER||Difference in LS Means|-38.73|||<|0.001|TWO_SIDED|95.0|-65.94|-11.52||The stepwise linear trend test adjusted for multiplicity within the family of comparisons of active doses with placebo and preserved the Type I error rate. P-value is for Placebo through Odanacatib 10 mg dose.|ANCOVA|||The log-transformed fraction from baseline in biomarker levels was analyzed using an ANCOVA model with terms for treatment and study center, using a stepwise linear contrast test based on the ANCOVA model. The geometric mean percent change from baseline (back-transformation from the mean log-transformed fraction) and the associated 95% confidence intervals were presented.||-11.52|-65.94|<0.001
72347359|NCT00620113|144216236|SUPERIORITY_OR_OTHER||Difference in LS Means|-42.91|||<|0.001|TWO_SIDED|95.0|-65.55|-20.27||The stepwise linear trend test adjusted for multiplicity within the family of comparisons of active doses with placebo and preserved the Type I error rate. P-value is for Placebo through Odanacatib 50 mg dose.|ANCOVA|||The log-transformed fraction from baseline in biomarker levels was analyzed using an ANCOVA model with terms for treatment and study center, using a stepwise linear contrast test based on the ANCOVA model. The geometric mean percent change from baseline (back-transformation from the mean log-transformed fraction) and the associated 95% confidence intervals were presented.||-20.27|-65.55|<0.001
72347360|NCT00620113|144216236|SUPERIORITY_OR_OTHER||Difference in LS Means|-37.45||||0.001|TWO_SIDED|95.0|-60.32|-14.59||The stepwise linear trend test adjusted for multiplicity within the family of comparisons of active doses with placebo and preserved the Type I error rate. P-value is for Placebo through Odanacatib 25 mg dose.|ANCOVA|||The log-transformed fraction from baseline in biomarker levels was analyzed using an ANCOVA model with terms for treatment and study center, using a stepwise linear contrast test based on the ANCOVA model. The geometric mean percent change from baseline (back-transformation from the mean log-transformed fraction) and the associated 95% confidence intervals were presented.||-14.59|-60.32|0.001
72347361|NCT00620113|144216236|SUPERIORITY_OR_OTHER||Difference in LS Means|-26.77||||0.017|TWO_SIDED|95.0|-50.37|-3.16||The stepwise linear trend test adjusted for multiplicity within the family of comparisons of active doses with placebo and preserved the Type I error rate. P-value is for Placebo through Odanacatib 10 mg dose.|ANCOVA|||The log-transformed fraction from baseline in biomarker levels was analyzed using an ANCOVA model with terms for treatment and study center, using a stepwise linear contrast test based on the ANCOVA model. The geometric mean percent change from baseline (back-transformation from the mean log-transformed fraction) and the associated 95% confidence intervals were presented.||-3.16|-50.37|0.017
72347362|NCT00620113|144216237|SUPERIORITY_OR_OTHER||Difference in LS Means|-15.52|||<|0.001|TWO_SIDED|95.0|-25.11|-5.93||The stepwise linear trend test adjusted for multiplicity within the family of comparisons of active doses with placebo and preserved the Type I error rate. P-value is for Placebo through Odanacatib 50 mg dose.|ANCOVA|||The log-transformed fraction from baseline in biomarker levels was analyzed using an ANCOVA model with terms for treatment and study center, using a stepwise linear contrast test based on the ANCOVA model. The geometric mean percent change from baseline (back-transformation from the mean log-transformed fraction) and the associated 95% confidence intervals were presented.||-5.93|-25.11|<0.001
72347363|NCT00620113|144216237|SUPERIORITY_OR_OTHER||Difference in LS Means|-12.55||||0.009|TWO_SIDED|95.0|-22.16|-2.94||The stepwise linear trend test adjusted for multiplicity within the family of comparisons of active doses with placebo and preserved the Type I error rate. P-value is for Placebo through Odanacatib 25 mg dose.|ANCOVA|||The log-transformed fraction from baseline in biomarker levels was analyzed using an ANCOVA model with terms for treatment and study center, using a stepwise linear contrast test based on the ANCOVA model. The geometric mean percent change from baseline (back-transformation from the mean log-transformed fraction) and the associated 95% confidence intervals were presented.||-2.94|-22.16|0.009
72347364|NCT00620113|144216237|SUPERIORITY_OR_OTHER||Difference in LS Means|2.48||||0.598|TWO_SIDED|95.0|-7.79|12.74||The stepwise linear trend test adjusted for multiplicity within the family of comparisons of active doses with placebo and preserved the Type I error rate. P-value is for Placebo through Odanacatib 10 mg dose.|ANCOVA|||The log-transformed fraction from baseline in biomarker levels was analyzed using an ANCOVA model with terms for treatment and study center, using a stepwise linear contrast test based on the ANCOVA model. The geometric mean percent change from baseline (back-transformation from the mean log-transformed fraction) and the associated 95% confidence intervals were presented.||12.74|-7.79|0.598
72347365|NCT00620113|144216238|SUPERIORITY_OR_OTHER||Difference in LS Means|-26.86|||<|0.001|TWO_SIDED|95.0|-43.3|-10.42||The stepwise linear trend test adjusted for multiplicity within the family of comparisons of active doses with placebo and preserved the Type I error rate. P-value is for Placebo through Odanacatib 50 mg dose.|ANCOVA|||The log-transformed fraction from baseline in biomarker levels was analyzed using an ANCOVA model with terms for treatment and study center, using a stepwise linear contrast test based on the ANCOVA model. The geometric mean percent change from baseline (back-transformation from the mean log-transformed fraction) and the associated 95% confidence intervals were presented.||-10.42|-43.30|<0.001
72347366|NCT00620113|144216238|SUPERIORITY_OR_OTHER||Difference in LS Means|-28.86|||<|0.001|TWO_SIDED|95.0|-44.97|-12.75||The stepwise linear trend test adjusted for multiplicity within the family of comparisons of active doses with placebo and preserved the Type I error rate. P-value is for Placebo through Odanacatib 25 mg dose.|ANCOVA|||The log-transformed fraction from baseline in biomarker levels was analyzed using an ANCOVA model with terms for treatment and study center, using a stepwise linear contrast test based on the ANCOVA model. The geometric mean percent change from baseline (back-transformation from the mean log-transformed fraction) and the associated 95% confidence intervals were presented.||-12.75|-44.97|<0.001
72347367|NCT00620113|144216238|SUPERIORITY_OR_OTHER||Difference in LS Means|-5.61||||0.458|TWO_SIDED|95.0|-23.79|12.56||The stepwise linear trend test adjusted for multiplicity within the family of comparisons of active doses with placebo and preserved the Type I error rate. P-value is for Placebo through Odanacatib 10 mg dose.|ANCOVA|||The log-transformed fraction from baseline in biomarker levels was analyzed using an ANCOVA model with terms for treatment and study center, using a stepwise linear contrast test based on the ANCOVA model. The geometric mean percent change from baseline (back-transformation from the mean log-transformed fraction) and the associated 95% confidence intervals were presented.||12.56|-23.79|0.458
72429062|NCT02404493|144368951|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.07|STANDARD_ERROR_OF_MEAN|0.228||0.767|TWO_SIDED|95.0|-0.41|0.547||The significance level threshold level was 0.05.|ANCOVA|Change from baseline as response, baseline score as covariate and treatment as factor.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.547|-0.410|0.767
72347368|NCT01979133|144216252|SUPERIORITY_OR_OTHER|||||||0.012|||||||Wilcoxon (Mann-Whitney)|||||||.012
72429063|NCT02404493|144368952|SUPERIORITY_OR_OTHER||||||<|0.001||||||The significance level threshold level was 0.05.|One sample t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||<0.001
72347369|NCT01979133|144216253|SUPERIORITY_OR_OTHER|||||||0.005|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.005
72347370|NCT01979133|144216254|SUPERIORITY_OR_OTHER|||||||0.017|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.017
72347371|NCT01979133|144216255|SUPERIORITY_OR_OTHER|||||||0.038|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.038
72347372|NCT01979133|144216256|SUPERIORITY_OR_OTHER|||||||0.034|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.034
72347373|NCT01979133|144216257|SUPERIORITY_OR_OTHER|||||||0.231|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.231
72347374|NCT01979133|144216258|SUPERIORITY_OR_OTHER|||||||0.066|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.066
72347375|NCT00486824|144216259|SUPERIORITY|||||||0.004|||||||Fisher Exact|||||||0.004
72347376|NCT00826618|144216361|SUPERIORITY_OR_OTHER|||||||0.0015|||||||t-test, 2 sided|||Compare final visual acuity to baseline visual acuity||||0.0015
72347377|NCT03781414|144216388|NON_INFERIORITY|The primary objective would be demonstrated, if the composite efficacy failure rate difference between any of the two CFZ533 arms and the TAC arm is less than the pre-defined non-inferiority margin (0.15) with probability \>80%.|Rate difference|0.0759|||||TWO_SIDED|95.0|-0.0729|0.2165||||||||0.2165|-0.0729|
72347378|NCT03781414|144216388|NON_INFERIORITY|The primary objective would be demonstrated, if the composite efficacy failure rate difference between any of the two CFZ533 arms and the TAC arm is less than the pre-defined non-inferiority margin (0.15) with probability \>80%.|Rate difference|0.1696|||||TWO_SIDED|95.0|0.0072|0.3276||||||||0.3276|0.0072|
72347379|NCT00719355|144216417|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.25|STANDARD_DEVIATION|14.4||0.033|TWO_SIDED|95.0||||A priori level of significance was set at p \<0.05.|ANCOVA|Repeated-measures ANCOVA using intent-to-treat procedures, was used for the primary outcome variable. Analyses were adjusted for age.||Observed power for our primary analysis was 0.64.||||0.033
72347380|NCT00719355|144216418|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.4|STANDARD_DEVIATION|3.65||0.109||95.0|||||ANCOVA|Repeated measures ANCOVA was used with intent to treat analysis. The co-variant was age.||||||0.109
72347381|NCT01835158|144216419|SUPERIORITY||Hazard Ratio (HR)|0.66||||0.012|TWO_SIDED|95.0|0.46|0.95|||Log Rank|||||.95|.46|0.012
72347382|NCT01835158|144216420|SUPERIORITY||Hazard Ratio (HR)|0.8|||||TWO_SIDED|95.0|0.5|1.26||||||||1.26|0.50|
72347383|NCT02932748|144216458|SUPERIORITY||||||<|0.0001||||||A global one-way ANOVA was followed by two pairwise t-tests on the comparisons of interest, i.e., IP vs. EUC, and GP vs IP for weight change across 6 months, evaluated at p ≤ 0.025, using both intent-to-treat and completer only data.|ANOVA|||||||<.0001
72347384|NCT00475904|144216466|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.547|STANDARD_ERROR_OF_MEAN|0.2709||0.0441|TWO_SIDED|95.0|0.01|1.08||a priori threshold for statistical significance was p\<0.05|ANOVA|||In the initial analysis, the efficacy of the test treatment NP-1 cream was compared with placebo using an analysis of variance (ANOVA). The analysis was conducted using the ITT population to compare the mean changes in pain scores from baseline to endpoint for the 2 treatments; the LOCF approach was employed for patients who did not complete the trial.||1.08|0.01|0.0441
72347385|NCT00475904|144216467|NON_INFERIORITY_OR_EQUIVALENCE|To conclude that the NP-1 was not inferior to gabapentin, the upper limit of the 2-sided 90% CI for the difference between treatments for the endpoint mean pain score was required to be below the non-inferiority margin of 0.70.|Mean Difference (Final Values)|0.046|STANDARD_ERROR_OF_MEAN|0.2311||0.8409|TWO_SIDED|90.0|-0.33|0.43||To conclude that the NP-1 was not inferior to gabapentin, the upper limit of the 2-sided 90% CI for the difference between treatments for the endpoint mean pain score was required to be below the non-inferiority margin of 0.70.|ANCOVA|||the primary hypothesis of this study was that NP-1 topical cream (amitriptyline 4%/ketamine 2%) administered twice daily in doses of 4 gm for 4 weeks is not inferior to the standard treatment (oral gabapentin 600 mg 3 times daily) for relieving the pain of adult patients with PHN.||0.43|-0.33|0.8409
72347386|NCT00066963|144216468|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|3.8|||<|0.001|TWO_SIDED|95.0|1.9|7.6|||Mantel Haenszel|2 d.f.|Counseling Only vs FV 2x/yr+Counseling|Planned sample size of 384 participants (128/study arm) (alpha = 0.05, power = 90%, 50% attrition, χ2 test) to detect caries incidence differences, based on caries incidence in the literature (20% to 50% over two years). 50% attrition in the sample size calculation was selected based on the literature (e.g. Weinstein et al., 1994 reported 53% attrition in six months.)||7.6|1.9|<0.001
72347387|NCT00988091|144216469|SUPERIORITY_OR_OTHER||Adjusted mean difference|5.33||||0.034|TWO_SIDED|95.0|0.41|10.24||The p-value was not adjusted for multiple comparisons because there was a single treatment comparison for the primary endpoint. The a priori threshold for statistical significance was p \<0.05.|Mixed Models Repeated Measures ANCOVA|The analysis included baseline score as a covariate and study center as a stratification variable.||A treatment difference of \>=7.0 mm and a pooled SD of 27.6 mm, requires a sample size of 244 subjects/treatment to complete the trial at 80% power at a two-sided significance level of 5%. To account for 18% dropout rate, the sample size was increased to 298/arm (total of 596). The primary null hypothesis (Ho) is that the effect of the two treatment groups at 26 weeks is equal and the corresponding alternative hypothesis (HA) is that the effect of the two treatment groups at 26 weeks is unequal.||10.24|0.41|0.034
72347388|NCT00988091|144216470|SUPERIORITY_OR_OTHER||Adjusted mean difference|2.89||||0.175|TWO_SIDED|95.0|-1.29|7.08||For secondary outcome measures, fixed-sequence testing was used in a sequentially rejective fashion. The a priori threshold for statistical significance was p \<0.05.|Mixed Models Repeated Measures ANCOVA|The analysis included baseline score as a covariate and study center as a stratification variable.||The null hypothesis (Ho) is that the effect of the two treatment groups at 26 weeks is equal and the corresponding alternative hypothesis (HA) is that the effect of the two treatment groups at 26 weeks is unequal.||7.08|-1.29|0.175
72347389|NCT00988091|144216471|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.777||||0.193|TWO_SIDED|95.0|0.532|1.136||For secondary outcome measures, fixed-sequence testing was used in a sequentially rejective fashion. The a priori threshold for statistical significance was p \<0.05.|Regression, Logistic|The analysis included study center as a stratification variable.||The null hypothesis (Ho) is that the effect of the two treatment groups at 26 weeks is equal and the corresponding alternative hypothesis (HA) is that the effect of the two treatment groups at 26 weeks is unequal.||1.136|0.532|0.193
72370169|NCT00838513|144250673|SUPERIORITY_OR_OTHER||Percent of hematologic normalization|90.0|||||TWO_SIDED|95.0|68.0|99.0||||||All analyses were based on the pooled data from the two protocols: C08-003A (adult) and C08-003B (adolescent), a similar protocol, for patients \<18 years with aHUS.||99|68|
72347390|NCT00988091|144216472|SUPERIORITY_OR_OTHER|||||||0.887||95.0||||For secondary outcome measures, fixed-sequence testing was used in a sequentially rejective fashion. The a priori threshold for statistical significance was p \<0.05.|Cochran-Mantel-Haenszel|The analysis included study center as a stratification variable.||The null hypothesis (Ho) is that the effect of the two treatment groups at 26 weeks is equal and the corresponding alternative hypothesis (HA) is that the effect of the two treatment groups at 26 weeks is unequal.||||0.887
72347391|NCT00988091|144216474|SUPERIORITY_OR_OTHER||Adjusted mean difference|4.0||||0.116|TWO_SIDED|95.0|-0.99|8.98||For secondary outcome measures, fixed-sequence testing was used in a sequentially rejective fashion. The a priori threshold for statistical significance was p \<0.05.|Mixed Models Repeated Measures ANCOVA|The analysis included baseline score as a covariate and study center as a stratification variable.||The null hypothesis (Ho) is that the effect of the two treatment groups at 26 weeks is equal and the corresponding alternative hypothesis (HA) is that the effect of the two treatment groups at 26 weeks is unequal.||8.98|-0.99|0.116
72347392|NCT00988091|144216475|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.71||||0.081|TWO_SIDED|95.0|0.483|1.044||For secondary outcome measures, fixed-sequence testing was used in a sequentially rejective fashion. The a priori threshold for statistical significance was p \<0.05.|Regression, Logistic|The analysis included study center as a stratification variable.||The null hypothesis (Ho) is that the effect of the two treatment groups at 26 weeks is equal and the corresponding alternative hypothesis (HA) is that the effect of the two treatment groups at 26 weeks is unequal.\[||1.044|0.483|0.081
72347393|NCT03422536|144216484|EQUIVALENCE|The pre-specified significance criteria were met by exclusion of the historical control PFS of 2.0 months. As confirmation, the one-sample log rank test was computed with expected survival estimated using an exponential distribution of 2.0 months.||||||0.04||||||The a priori threshold for statistical significance is \<.05|Log Rank|||||||.04
72347394|NCT03422536|144216489|SUPERIORITY|||||||0.005|||||||Regression, Cox|||c-Met positivity was compared across groups: HPV+ vs HPV-||||.005
72347395|NCT03422536|144216489|SUPERIORITY||Cox Proportional Hazard|0.3||||0.02|TWO_SIDED|95.0|0.1|0.8|||Log Rank|||Post-hoc comparison of progression free survival (PFS) in cMet positive vs. c-Met negative patients.||0.8|0.1|.02
72347396|NCT03422536|144216489|SUPERIORITY||Cox Proportional Hazard|0.1||||0.03|TWO_SIDED|95.0|0.03|0.8|||Log Rank|||Post hoc comparison of PFS in the combination arm by HPV subgroup, adjusted for prognostic factors marginally associated with HPV status (P , .10), was assessed using Cox proportional hazards models. Here we are looking at cMet positivity in HPV- patients in the combination arm.||0.8|0.03|0.03
72347397|NCT03422536|144216489|SUPERIORITY||Cox Proportional Hazard|3.2||||0.2|TWO_SIDED|95.0|0.6|17.5|||Log Rank|||Post hoc comparison of PFS in the combination arm by HPV subgroup, adjusted for prognostic factors marginally associated with HPV status (P , .10), was assessed using Cox proportional hazards models. Here we are looking at cMet positivity in HPV+ patients in the combination arm.||17.5|0.6|.20
72347398|NCT03422536|144216489|SUPERIORITY||Cox Proportional Hazard|1.4||||0.1|TWO_SIDED|95.0|0.9|2.0|||Log Rank|||Post-hoc comparison of progression free survival (PFS) in HGF positive vs. HGF negative patients.||2.0|0.9|.10
72347399|NCT03422536|144216489|SUPERIORITY||Cox Proportional Hazard|1.4||||0.6|TWO_SIDED|95.0|0.4|4.7|||Log Rank|||Post hoc comparison of PFS in the combination arm by HPV subgroup, adjusted for prognostic factors marginally associated with HPV status (P , .10), was assessed using Cox proportional hazards models. Here we are looking at HGF expression in HPV- patients in the combination arm.||4.7|0.4|.60
72347400|NCT03422536|144216489|SUPERIORITY||Cox Proportional Hazard|3.4||||0.07|TWO_SIDED|95.0|0.9|13.1|||Log Rank|||Post hoc comparison of PFS in the combination arm by HPV subgroup, adjusted for prognostic factors marginally associated with HPV status (P \< .10), was assessed using Cox proportional hazards models. Here we are looking at HGF expression in HPV+ patients in the combination arm.||13.1|0.9|.07
72347401|NCT05758402|144216496|OTHER||Rate difference|1.21||||0.544|TWO_SIDED|95.0|-2.71|5.13|||Chi-squared||Rate difference = detection rate of PsA in EARP group - detection rate of PsA in routine practice group|||5.13|-2.71|0.544
72347402|NCT05758402|144216497|OTHER|||||||0.256|||||||Chi-squared|||Sensitivity||||0.256
72347403|NCT05758402|144216497|OTHER||||||<|0.001|||||||Chi-squared|||Specificity||||<0.001
72347404|NCT05758402|144216497|OTHER|||||||0.336|||||||Fisher Exact|||Positive Predictive Value (PPV)||||0.336
72347405|NCT05758402|144216497|OTHER|||||||0.49|||||||Chi-squared|||Negative Predictive Value (NPV)||||0.490
72347406|NCT05758402|144216498|OTHER|||||||0.101|||||||Wilcoxon (Mann-Whitney)|||Age characteristics||||0.101
72347407|NCT05758402|144216499|OTHER|||||||0.836|||||||Chi-squared|||Gender characteristics||||0.836
72347408|NCT05758402|144216500|OTHER|||||||0.52|||||||Wilcoxon (Mann-Whitney)|||Body Mass Index (BMI) characteristics||||0.520
72347409|NCT05758402|144216501|OTHER|||||||0.216|||||||Chi-squared|||Drinking history characteristics||||0.216
72347410|NCT05758402|144216501|OTHER|||||||0.719|||||||Chi-squared|||Smoking history characteristics||||0.719
72347411|NCT05758402|144216502|OTHER|||||||0.831|||||||Wilcoxon (Mann-Whitney)|||Duration of Psoriasis (PsO) characteristics||||0.831
72347412|NCT05758402|144216503|OTHER|||||||0.274|||||||Fisher Exact|||Family history of psoriasis (PsO) characteristics||||0.274
72347413|NCT05758402|144216503|OTHER|||||||0.272|||||||Fisher Exact|||Family history of psoriatic arthritis (PsA) characteristics||||0.272
72347414|NCT05758402|144216504|OTHER|||||||0.622|||||||Wilcoxon (Mann-Whitney)|||Psoriasis Area and Severity Index (PASI) score characteristics||||0.622
72347415|NCT05758402|144216505|OTHER||||||<|0.001|||||||Chi-squared|||Status of hard-to-treat area involvement characteristics||||<0.001
72347416|NCT05758402|144216505|OTHER||||||<|0.001|||||||Chi-squared|||Status of musculoskeletal symptoms characteristics||||<0.001
72347417|NCT05758402|144216506|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||NAPSI score of left hand characteristics||||<0.001
72347418|NCT05758402|144216506|OTHER|||||||0.01|||||||Wilcoxon (Mann-Whitney)|||NAPSI score of right hand characteristics||||0.010
72347419|NCT05758402|144216506|OTHER|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||NAPSI score of left foot characteristics||||0.001
72347420|NCT05758402|144216506|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||NAPSI score of right foot characteristics||||<0.001
72347421|NCT05758402|144216506|OTHER|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||Total NAPSI score characteristics||||0.001
72347422|NCT05758402|144216507|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||SJC66 total joint count characteristics||||<0.001
72347423|NCT05758402|144216507|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||TJC68 total joint count characteristics||||<0.001
72347424|NCT05758402|144216507|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||SJC66/TJC68 total joint count characteristics||||<0.001
72347425|NCT05758402|144216508|OTHER|||||||0.043|||||||Fisher Exact|||Heart diseases||||0.043
72347426|NCT05758402|144216508|OTHER|||||||1|||||||Fisher Exact|||Stroke||||1.000
72347427|NCT05758402|144216508|OTHER|||||||1|||||||Fisher Exact|||Diabetes||||1.000
72347428|NCT05758402|144216508|OTHER|||||||0.019|||||||Chi-squared|||Hyperlipidemia||||0.019
72347429|NCT05758402|144216508|OTHER|||||||0.073|||||||Chi-squared|||Hypertension||||0.073
72347430|NCT05758402|144216508|OTHER|||||||0.377|||||||Fisher Exact|||Fatty liver||||0.377
72347431|NCT00395850|144216512|SUPERIORITY_OR_OTHER||Slope|-1.02|||<|0.05|||||||Repeated Measures Logistic Regression|Repeated Measures Generalized Linear Models on a Binomial distribution, thus a Repeated Measures Logistic Regression||Used placebo group as contrast to determine whether slopes of disulfiram groups differed from slope of placebo group data||||<0.05
72347432|NCT00395850|144216513|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.5|||<|0.05||95.0|||||t-test, 2 sided|||||||<0.05
72347433|NCT01846741|144216520|SUPERIORITY_OR_OTHER|||||||0.008|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Baseline to 3 months||||0.008
72347434|NCT01846741|144216520|SUPERIORITY_OR_OTHER|||||||0.04|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero||Baseline to 6 months||||0.040
72347435|NCT01846741|144216520|SUPERIORITY_OR_OTHER|||||||0.033|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero||Baseline to 12 months||||0.033
72347436|NCT01846741|144216520|SUPERIORITY_OR_OTHER|||||||0.5|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Baseline to 3 months||||0.500
72347437|NCT01846741|144216520|SUPERIORITY_OR_OTHER|||||||0.75|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Baseline to 6 months||||0.750
72347438|NCT01846741|144216520|SUPERIORITY_OR_OTHER|||||||0.156|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Baseline to 12 months||||0.156
72347439|NCT01846741|144216520|SUPERIORITY_OR_OTHER|||||||0.938|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Baseline to 3 months||||0.938
72347440|NCT01846741|144216520|SUPERIORITY_OR_OTHER|||||||0.25|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Baseline to 6 months||||0.250
72347441|NCT01846741|144216520|SUPERIORITY_OR_OTHER|||||||0.999|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Baseline to 12 months||||0.999
72347442|NCT01846741|144216520|SUPERIORITY_OR_OTHER|||||||0.057|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Baseline to 18 Months||||0.057
72347443|NCT01846741|144216520|SUPERIORITY_OR_OTHER|||||||0.031|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Baseline to 18 Months||||0.031
72347444|NCT01846741|144216520|SUPERIORITY_OR_OTHER|||||||0.625|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Baseline to 18 Months||||0.625
72347445|NCT01846741|144216521|SUPERIORITY_OR_OTHER|||||||0.0008|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||SSQ Total Score||||0.0008
72347446|NCT01846741|144216521|SUPERIORITY_OR_OTHER|||||||0.0544|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Activity During Seizure Score||||0.0544
72347447|NCT01846741|144216521|SUPERIORITY_OR_OTHER|||||||0.0207|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Overall Recovery Score||||0.0207
72347448|NCT01846741|144216521|SUPERIORITY_OR_OTHER|||||||0.0163|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Overall Severity Score||||0.0163
72347449|NCT01846741|144216521|SUPERIORITY_OR_OTHER|||||||0.0156|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Postictal Emotional Recovery Score||||0.0156
72347450|NCT01846741|144216521|SUPERIORITY_OR_OTHER|||||||0.0742|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Postictal Physical Recovery Score||||0.0742
72347451|NCT01846741|144216521|SUPERIORITY_OR_OTHER|||||||0.0884|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Postictal Cognitive Recovery Score||||0.0884
72347452|NCT01846741|144216521|SUPERIORITY_OR_OTHER|||||||0.0007|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||SSQ Total Score||||0.0007
72347453|NCT01846741|144216521|SUPERIORITY_OR_OTHER|||||||0.1173|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Activity During Seizure||||0.1173
72347454|NCT01846741|144216521|SUPERIORITY_OR_OTHER|||||||0.0214|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Overall Recovery||||0.0214
72347455|NCT01846741|144216521|SUPERIORITY_OR_OTHER|||||||0.0114|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Overall Severity||||0.0114
72347456|NCT01846741|144216521|SUPERIORITY_OR_OTHER|||||||0.0078|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Postictal Emotional Recovery||||0.0078
72347457|NCT01846741|144216521|SUPERIORITY_OR_OTHER|||||||0.0875|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Postictal Physical Recovery||||0.0875
72347458|NCT01846741|144216521|SUPERIORITY_OR_OTHER|||||||0.1526|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Postictal Cognitive Recovery||||0.1526
72347459|NCT01846741|144216521|SUPERIORITY_OR_OTHER|||||||0.0031|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||SSQ Total Score||||0.0031
72347460|NCT01846741|144216521|SUPERIORITY_OR_OTHER|||||||0.0828|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Activity During Seizure||||0.0828
72347461|NCT01846741|144216521|SUPERIORITY_OR_OTHER|||||||0.0092|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Overall Recovery||||0.0092
72347462|NCT01846741|144216521|SUPERIORITY_OR_OTHER|||||||0.0096|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Overall Severity||||0.0096
72347463|NCT01846741|144216521|SUPERIORITY_OR_OTHER|||||||0.0234|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Postictal Emotional Recovery||||0.0234
72347464|NCT01846741|144216521|SUPERIORITY_OR_OTHER|||||||0.0284|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Postictal Physical Recovery||||0.0284
72347465|NCT01846741|144216521|SUPERIORITY_OR_OTHER|||||||0.0679|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Postictal Cognitive Recovery||||0.0679
72347466|NCT01846741|144216521|SUPERIORITY_OR_OTHER|||||||0.0003|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||SSQ Total Score||||0.0003
72347467|NCT01846741|144216521|SUPERIORITY_OR_OTHER|||||||0.0728|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Activity During Seizures Score||||0.0728
72347468|NCT01846741|144216521|SUPERIORITY_OR_OTHER|||||||0.0005|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Overall Recovery Score||||0.0005
72347469|NCT01846741|144216521|SUPERIORITY_OR_OTHER|||||||0.0005|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Overall Severity Score||||0.0005
72347470|NCT01846741|144216521|SUPERIORITY_OR_OTHER|||||||0.0078|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Postictal Emotional Recovery Score||||0.0078
72347471|NCT01846741|144216521|SUPERIORITY_OR_OTHER|||||||0.0078|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Postictal Physical Recovery Score||||0.0078
72347472|NCT01846741|144216521|SUPERIORITY_OR_OTHER|||||||0.0273|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Postictal Cognitive Recovery Score||||0.0273
72429064|NCT02404493|144368952|SUPERIORITY_OR_OTHER|||||||0.004||||||The significance level threshold level was 0.05.|One sample t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||0.004
72429065|NCT02404493|144368952|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.14|STANDARD_ERROR_OF_MEAN|0.242||0.571|TWO_SIDED|95.0|-0.65|0.37||The significance level threshold level was 0.05.|ANCOVA|Change from baseline as response, baseline score as covariate and treatment as factor.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.370|-0.650|0.571
72347473|NCT01846741|144216522|SUPERIORITY_OR_OTHER|||||||0.0192|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||QOLIE Overall Total||||0.0192
72347474|NCT01846741|144216522|SUPERIORITY_OR_OTHER|||||||0.8069|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Energy/Fatigue||||0.8069
72347475|NCT01846741|144216522|SUPERIORITY_OR_OTHER|||||||0.2416|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Emotional well being||||0.2416
72347476|NCT01846741|144216522|SUPERIORITY_OR_OTHER|||||||0.1111|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Social Functioning||||0.1111
72347477|NCT01846741|144216522|SUPERIORITY_OR_OTHER|||||||0.0014|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Cognitive Functioning||||0.0014
72347478|NCT01846741|144216522|SUPERIORITY_OR_OTHER|||||||0.3247|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Medication Effects||||0.3247
72347479|NCT01846741|144216522|SUPERIORITY_OR_OTHER|||||||0.0826|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Seizure Worry||||0.0826
72347480|NCT01846741|144216522|SUPERIORITY_OR_OTHER|||||||0.104|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Overall Quality of Life||||0.1040
72347481|NCT01846741|144216522|SUPERIORITY_OR_OTHER|||||||0.0094|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||QOLIE Overall Total||||0.0094
72347482|NCT01846741|144216522|SUPERIORITY_OR_OTHER|||||||0.5874|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Energy/Fatigue||||0.5874
72347483|NCT01846741|144216522|SUPERIORITY_OR_OTHER|||||||0.1508|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Emotional well being||||0.1508
72347484|NCT01846741|144216522|SUPERIORITY_OR_OTHER|||||||0.0136|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Social Functioning||||0.0136
72347485|NCT01846741|144216522|SUPERIORITY_OR_OTHER|||||||0.0015|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Cognitive Functioning||||0.0015
72347486|NCT01846741|144216522|SUPERIORITY_OR_OTHER|||||||0.3522|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Medication Effects||||0.3522
72347487|NCT01846741|144216522|SUPERIORITY_OR_OTHER|||||||0.024|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Seizure Worry||||0.0240
72347488|NCT01846741|144216522|SUPERIORITY_OR_OTHER|||||||0.0353|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Overall Quality of Life||||0.0353
72347489|NCT01846741|144216522|SUPERIORITY_OR_OTHER|||||||0.0361|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||QOLIE Overall Total Score||||0.0361
72347490|NCT01846741|144216522|SUPERIORITY_OR_OTHER|||||||0.1921|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Energy/Fatigue||||0.1921
72347491|NCT01846741|144216522|SUPERIORITY_OR_OTHER|||||||0.1639|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Emotional well being||||0.1639
72347492|NCT01846741|144216522|SUPERIORITY_OR_OTHER|||||||0.1738|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Social Functioning||||0.1738
72347493|NCT01846741|144216522|SUPERIORITY_OR_OTHER|||||||0.0401|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Cognitive Functioning||||0.0401
72347494|NCT01846741|144216522|SUPERIORITY_OR_OTHER|||||||0.2753|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Medication Effects||||0.2753
72347495|NCT01846741|144216522|SUPERIORITY_OR_OTHER|||||||0.0056|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Seizure Worry||||0.0056
72347496|NCT01846741|144216522|SUPERIORITY_OR_OTHER|||||||0.1173|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Overall Quality of Life||||0.1173
72347497|NCT01846741|144216522|SUPERIORITY_OR_OTHER|||||||0.0268|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||QOLIE Overall Total||||0.0268
72347498|NCT01846741|144216522|SUPERIORITY_OR_OTHER|||||||0.4406|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Energy/Fatigue Final||||0.4406
72347499|NCT01846741|144216522|SUPERIORITY_OR_OTHER|||||||0.7926|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Emotional Well Being Final||||0.7926
72347500|NCT01846741|144216522|SUPERIORITY_OR_OTHER|||||||0.0987|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Social Functioning Final||||0.0987
72347501|NCT01846741|144216522|SUPERIORITY_OR_OTHER|||||||0.0361|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Cognitive Functioning Final||||0.0361
72347502|NCT01846741|144216522|SUPERIORITY_OR_OTHER|||||||0.0615|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Medication Effects Final||||0.0615
72347503|NCT01846741|144216522|SUPERIORITY_OR_OTHER|||||||0.0024|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Seizure Worry||||0.0024
72347504|NCT01846741|144216522|SUPERIORITY_OR_OTHER|||||||0.0155|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Overall Quality of Life||||0.0155
72347505|NCT01846741|144216524|SUPERIORITY_OR_OTHER|||||||0.0625|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||3 months||||0.0625
72347506|NCT01846741|144216524|SUPERIORITY_OR_OTHER|||||||0.1094|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||6 months||||0.1094
72347507|NCT01846741|144216524|SUPERIORITY_OR_OTHER|||||||0.0342|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||12 months||||0.0342
72347508|NCT01846741|144216524|SUPERIORITY_OR_OTHER|||||||0.5417|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero||18 Months||||0.5417
72347509|NCT03533244|144216552|SUPERIORITY|||||||0.218||||||To reserve the family-wise error rate, the main treatment effect will be first assessed at the global level at alpha = 0.05. If this is significant, then pairwise comparisons will be conducted using the Bonferroni adjustment for multiplicity.|Mixed Models Analysis|||An empirical sample size estimation was used as this was an exploratory study. The null hypothesis is that there is no difference between AG-86893 and AG-86893 Vehicle. It is expected that the active group is at least 50% better than the vehicle.||||0.218
72347510|NCT03533244|144216552|SUPERIORITY|||||||0.29|||||||Mixed Models Analysis|||||||0.290
72347511|NCT03533244|144216553|SUPERIORITY|||||||0.193|||||||Mixed Models Analysis|||||||0.193
72347512|NCT03533244|144216553|SUPERIORITY|||||||0.399|||||||Mixed Models Analysis|||||||0.399
72347513|NCT03533244|144216554|SUPERIORITY|||||||0.015|||||||Fisher Exact|||||||0.015
72347514|NCT03533244|144216554|SUPERIORITY|||||||0.022|||||||Fisher Exact|||||||0.022
72347515|NCT01817959|144216555|SUPERIORITY||least square mean difference|0.001||||0.9863|TWO_SIDED|99.75|-0.205|0.207||Treatment p value|ANOVA|||||0.207|-0.205|0.9863
72347516|NCT01817959|144216556|SUPERIORITY||least square mean difference|0.024||||0.7115|TWO_SIDED|99.75|-0.184|0.232||Treatment p value|ANOVA|||||0.232|-0.184|0.7115
72347517|NCT01817959|144216557|SUPERIORITY||Odds Ratio, log|0.21||||0.1346|TWO_SIDED|95.0|0.03|1.63||Treatment p value|Regression, Logistic|||Analytical statistics are reported for Day 75 after transplant 2||1.63|0.03|0.1346
72347518|NCT01817959|144216558|SUPERIORITY||Odds Ratio (OR)|0.91||||0.913|TWO_SIDED|95.0|0.17|4.93||Treatment p value|Regression, Logistic|||||4.93|0.17|0.9130
72347519|NCT01817959|144216559|SUPERIORITY||Odds Ratio (OR)|0.65||||0.5467|TWO_SIDED|95.0|0.16|2.66||Treatment p value|Regression, Logistic|||||2.66|0.16|0.5467
72347520|NCT01817959|144216560|SUPERIORITY|||||||0.1383|||||||Fisher Exact|||||||0.1383
72347521|NCT01817959|144216562|SUPERIORITY||least square mean difference|-0.021||||0.6952|TWO_SIDED|95.0|-0.13|0.088||Treatment p value|ANCOVA|||This is is the analytic statistics for Day 75 (Transplant 1)||0.088|-0.130|0.6952
72347522|NCT01817959|144216562|SUPERIORITY||least square mean difference|0.028||||0.556|TWO_SIDED|95.0|-0.068|0.124||This is a treatment p value|ANCOVA|||This is is the analytic statistics for Day 75 (Transplant 2)||0.124|-0.068|0.5560
72347523|NCT01817959|144216562|SUPERIORITY||least square mean difference|0.056||||0.2537|TWO_SIDED|95.0|-0.042|0.154||Treatment p value|ANCOVA|Treatment p value||This is the analytic statics for Day 365 (last Transplant)||0.154|-0.042|0.2537
72347524|NCT01817959|144216563|SUPERIORITY||least square mean difference|-7.4||||0.591|TWO_SIDED|95.0|-35.2|20.3||Treatment p value|ANCOVA|||This is the analytic statics for Day 75 (Transplant 1)||20.3|-35.2|0.5910
72347525|NCT01817959|144216563|SUPERIORITY||least square mean difference|4.2||||0.5966|TWO_SIDED|95.0|-11.8|20.2||Treatment p value|ANCOVA|Treatment p value||This is the analytic statics for Day 75 (Transplant 2)||20.2|-11.8|0.5966
72429066|NCT00050089|144369064|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.165||||0.69|TWO_SIDED|95.0|0.856|1.585|||Log Rank||The comparison was Mega-ART (intensification) vs Standard-ART (standard).|Time-to-event (Kaplan-Meier) and stratified log-rank test was used for the comparison.||1.585|0.856|0.69
72429067|NCT00050089|144369065|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.927||||0.49|TWO_SIDED|95.0|0.674|1.275|||Log Rank||The comparison was ARDFP (interruption) vs No ARDFP (continuation)|Time-to-event (Kaplan-Meier) and stratified log-rank analysis was performed.||1.275|0.674|0.49
72347526|NCT01817959|144216563|SUPERIORITY||least square mean difference|6.1||||0.5005|TWO_SIDED|95.0|-12.1|24.4||Treatment p value|ANCOVA|||This is the analytic statics for Day 365 (last Transplant)||24.4|-12.1|0.5005
72347527|NCT01817959|144216564|SUPERIORITY||least square mean difference|0.21||||0.3253|TWO_SIDED|95.0|-0.21|0.63||Treatment p value|ANCOVA|||This is the analytic statics for Day 75 (Transplant 1)||0.63|-0.21|0.3253
72347528|NCT01817959|144216564|SUPERIORITY||least square mean difference|0.16||||0.6069|TWO_SIDED|95.0|-0.46|0.78||Treatment p value|least square mean difference|||This is the analytic statics for Day 75 (Transplant 2)||0.78|-0.46|0.6069
72347529|NCT01817959|144216564|SUPERIORITY||Least square mean difference|0.17||||0.6437|TWO_SIDED|95.0|-0.56|0.93||Treatment p value|ANCOVA|Treatment p value||This is the analytic statics for Day 365 (last Transplant)||0.93|-0.56|0.6437
72347530|NCT01817959|144216565|SUPERIORITY||least square mean difference|2.0||||0.429|TWO_SIDED|95.0|-3.0|6.9||Treatment p value|ANCOVA|||This is the analytic statistics for Day 75 (Transplant 1)||6.9|-3.0|0.4290
72347531|NCT01817959|144216565|SUPERIORITY||least square mean difference|1.0||||0.7853|TWO_SIDED|95.0|-6.3|8.3||Treatment p value|ANCOVA|||This is the analytic statistics for Day 75 (Transplant 2)||8.3|-6.3|0.7853
72347532|NCT01817959|144216565|SUPERIORITY||least square mean difference|1.9||||0.6583|TWO_SIDED|95.0|-6.6|10.4||Treatment p value|ANCOVA|||This is the analytic statistics for Day 365 (last Transplant)||10.4|-6.6|0.6583
72347533|NCT01817959|144216569|SUPERIORITY||Least square mean difference|0.0||||0.9949|TWO_SIDED|95.0|-1.28|1.28||Treatment p value|ANOVA|||This is the analytic statistics for Day 75 (Transplant 1)||1.28|-1.28|0.9949
72347534|NCT01817959|144216569|SUPERIORITY||Least square mean difference|0.1||||0.8753|TWO_SIDED|95.0|-1.18|1.38||Treatment p value|ANOVA|||This is the analytic statistics for Day 75 (Transplant 2)||1.38|-1.18|0.8753
72347535|NCT01817959|144216569|SUPERIORITY||Least square mean difference|-0.59||||0.3955|TWO_SIDED|95.0|-1.97|0.8||Treatment p value|ANOVA|||This is the analytic statistics for Day 365 (last Transplant)||0.80|-1.97|0.3955
72347536|NCT01817959|144216570|SUPERIORITY||Least square mean difference|-0.105||||0.2444|TWO_SIDED|95.0|-0.286|0.075||Treatment p value|ANOVA|||This is the analytic statistics for Day 75 (Transplant 1)||0.075|-0.286|0.2444
72347537|NCT01817959|144216570|SUPERIORITY||Least square mean difference|-0.218||||0.0328|TWO_SIDED|95.0|-0.417|-0.019||Treatment p value|ANOVA|||This is the analytic statistics for Day 75 (Transplant 2)||-0.019|-0.417|0.0328
72347538|NCT01817959|144216570|SUPERIORITY||Least square mean difference|-0.177||||0.1059|TWO_SIDED|95.0|-0.393|0.039||This is the analytic statistics for Day 75 (Transplant 2)|ANOVA|||This is the analytic statistics for Day 365 (last Transplant)||0.039|-0.393|0.1059
72347539|NCT02669121|144216626|SUPERIORITY||Cox Proportional Hazard|0.8|||||TWO_SIDED|99.99|-13.181|0.997|||||||The vaccine efficacy was met if lower bound of confidence interval (CI) for vaccine efficacy was above 0. Vaccine efficacy (VE) was defined as 1-(hazard rate for NoV vaccine arm / hazard rate for placebo arm), where the hazard ratio is from the Cox proportional hazard (PH) model. The 99.99% CI for the VE was obtained by taking 1 minus the 99.99% CI of the hazard ratio from the PH model.|0.997|-13.181|
72347540|NCT02669121|144216627|SUPERIORITY||Cox Proportional Hazard|0.618|||||TWO_SIDED|95.01|0.208|0.816|||||||The vaccine efficacy was met if lower bound of CI for vaccine efficacy was above 0. Vaccine efficacy (VE) was defined as 1-(hazard rate for NoV vaccine arm / hazard rate for placebo arm), where the hazard ratio is from the PH model. The 95.01% CI for the VE was obtained by taking 1 minus the 95.01% CI of the hazard ratio from the PH model.|0.816|0.208|
72347541|NCT02669121|144216628|SUPERIORITY||Cox Proportional Hazard|0.618|||||TWO_SIDED|95.0|0.208|0.816|||||||The vaccine efficacy was met if lower bound of CI for vaccine efficacy was above 0. Vaccine efficacy (VE) was defined as 1-(hazard rate for NoV vaccine arm / hazard rate for placebo arm), where the hazard ratio is from the PH model. The 95% CI for the VE was obtained by taking 1 minus the 95% CI of the hazard ratio from the PH model.|0.816|0.208|
72347542|NCT02669121|144216629|SUPERIORITY||Cox Proportional Hazard|0.8|||||TWO_SIDED|95.0|-0.711|0.977|||||||The vaccine efficacy was met if lower bound of CI for vaccine efficacy was above 0. Vaccine efficacy (VE) was defined as 1-(hazard rate for NoV vaccine arm / hazard rate for placebo arm), where the hazard ratio is from the PH model. The 95% CI for the VE was obtained by taking 1 minus the 95% CI of the hazard ratio from the PH model.|0.977|-0.711|
72347543|NCT03216746|144216630|OTHER|||||||0.001|||||||Kruskal-Wallis|||||||0.001
72347544|NCT00241904|144216662|SUPERIORITY||||||<|0.001|||||||General Linear Mixed Model|||Intention to treat analysis was used||||<0.001
72347545|NCT00241904|144216663|SUPERIORITY|||||||0.003|||||||General Linear Mixed Model|||||||0.003
72347546|NCT00241904|144216664|SUPERIORITY|||||||0.034|||||||General Linear Mixed Model|||||||0.034
72347547|NCT00241904|144216665|SUPERIORITY||||||<|0.001|||||||General Linear Mixed Model|||||||<0.001
72347548|NCT02980133|144216666|SUPERIORITY||LS mean difference|1.9||||0.285|TWO_SIDED|95.0|-1.6|5.3||Threshold for significance at 0.05 level.|ANCOVA|||Analysis was performed using an ANCOVA model with effects due to baseline trough morning percent predicted FEV1, sex, age, (pooled) investigational center, previous therapy (ICS or NCS), and IMP treatment group.||5.3|-1.6|0.285
72347549|NCT02980133|144216667|SUPERIORITY||Least square (LS) mean difference|6.0|||<|0.001|TWO_SIDED|95.0|3.2|8.8||Threshold for significance at 0.05 level.|ANCOVA|||Analysis was performed using an analysis of covariance (ANCOVA) model with effects due to baseline trough morning percent predicted FEV1, sex, age, (pooled) investigational center, previous therapy (inhaled corticosteroid \[ICS\] or noncorticosteroid \[NCS\]), and investigational medicinal product (IMP) treatment group.||8.8|3.2|<0.001
72347550|NCT02980133|144216667|SUPERIORITY||LS mean difference|7.0|||<|0.001|TWO_SIDED|95.0|4.1|9.8||Threshold for significance at 0.05 level.|ANCOVA|||Analysis was performed using an ANCOVA model with effects due to baseline trough morning percent predicted FEV1, sex, age, (pooled) investigational center, previous therapy (ICS or NCS), and IMP treatment group.||9.8|4.1|<0.001
72347551|NCT00825812|144216674|SUPERIORITY_OR_OTHER||ratio of geometric mean time to recovery|5.7||||||95.0|4.9|6.6|||ANOVA|ANOVA, adjusted for center effects, on log transformed times from start of administration of IMP to recovery of the T4/T1 ratio to 0.9.|Ratio of time to recovery of 0.9 T4/T1 ratio (neostigmine time / sugammadex time).|The primary analysis was the comparison of the two treatments among Chinese subjects.||6.6|4.9|
72347552|NCT00825812|144216674|SUPERIORITY_OR_OTHER||ratio of geometric mean time to recovery|4.8||||||97.5|3.7|6.0|||ANOVA|ANOVA, adjusted for center effects, on log transformed times from start of administration of IMP to recovery of the T4/T1 ratio to 0.9.|Ratio of time to recovery of 0.9 T4/T1 ratio (neostigmine time / sugammadex time).|A key secondary analysis was the comparison of the two treatments among Caucasian subjects.||6.0|3.7|
72347553|NCT00825812|144216674|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence was considered if the 97.5% confidence interval (CI) for median difference in recovery time (T4/T1 ratio to 0.9) was within the pre-specified range of -60 to +60 seconds.|median difference (seconds)|7.0||||||97.5|-5.0|21.0|||||Estimated median difference (Chinese - Caucasian) in seconds for the time to recovery of the T4/T1 ratio to 0.9 (after sugammadex).|A key secondary analysis was the comparison for equivalence between Chinese subjects and Caucasian subjects.||21|-5|
72347554|NCT00588354|144216681|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.54|STANDARD_ERROR_OF_MEAN|1.05||0.159|TWO_SIDED|95.0|-0.52|3.6|||ANCOVA|||Data were analyzed using analysis of covariance (ANCOVA) with baseline value included as a covariate.||3.60|-0.52|0.159
72347555|NCT00588354|144216682|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.11|STANDARD_ERROR_OF_MEAN|0.97||0.91|TWO_SIDED|95.0|-1.79|2.01|||ANCOVA|||Data were analyzed using analysis of covariance (ANCOVA) with baseline value included as a covariate.||2.01|-1.79|0.910
72347556|NCT00588354|144216683|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.96|STANDARD_ERROR_OF_MEAN|2.04||0.162|TWO_SIDED|95.0|-1.04|6.96|||ANCOVA|||Data were analyzed using analysis of covariance (ANCOVA) with baseline value included as a covariate.||6.96|-1.04|0.162
72347557|NCT00588354|144216684|SUPERIORITY_OR_OTHER||Mean Difference (Net)|5.67|STANDARD_ERROR_OF_MEAN|2.27||0.022|TWO_SIDED|95.0|1.22|10.12|||ANCOVA|||Data were analyzed using analysis of covariance (ANCOVA) with baseline value included as a covariate.||10.12|1.22|0.022
72347558|NCT00588354|144216685|SUPERIORITY_OR_OTHER||Median Difference (Net)|5.86|STANDARD_ERROR_OF_MEAN|3.28||0.089|TWO_SIDED|95.0|-0.57|12.29|||ANCOVA|||Data were analyzed using analysis of covariance (ANCOVA) with baseline value included as a covariate.||12.29|-0.57|0.089
72347559|NCT00588354|144216686|SUPERIORITY_OR_OTHER||Mean Difference (Net)|7.04|STANDARD_ERROR_OF_MEAN|3.17||0.038|TWO_SIDED|95.0|0.83|13.25|||ANCOVA|||Data were analyzed using analysis of covariance (ANCOVA) with baseline value included as a covariate.||13.25|0.83|0.038
72347560|NCT00588354|144216687|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.83|STANDARD_ERROR_OF_MEAN|3.53||0.186|TWO_SIDED|95.0|-11.75|2.09|||ANCOVA|||Data were analyzed using analysis of covariance (ANCOVA) with baseline value included as a covariate.||2.09|-11.75|0.186
72347561|NCT00588354|144216688|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.35|STANDARD_ERROR_OF_MEAN|3.37||0.918|TWO_SIDED|95.0|-6.96|6.26|||ANCOVA|||Data were analyzed using analysis of covariance (ANCOVA) with baseline value included as a covariate.||6.26|-6.96|0.918
72347562|NCT04000581|144216689|SUPERIORITY|||||||0.329|||||||t-test, 1 sided|||The null hypothesis is that the mean change is equal between the groups, while the alternative is that an increased difference is observed in arm 2. The hypotheses are evaluated using a one-sided, two-sample t-test.||||0.329
72347563|NCT02519595|144216705|SUPERIORITY_OR_OTHER|||||||0.2|||||||Kruskal-Wallis|||||||0.2
72347564|NCT02519595|144216706|SUPERIORITY_OR_OTHER|||||||0.09|||||||Kruskal-Wallis|||||||0.09
72347565|NCT02519595|144216707|SUPERIORITY_OR_OTHER|||||||0.2|||||||Kruskal-Wallis|||||||0.2
72347566|NCT02519595|144216709|SUPERIORITY_OR_OTHER|||||||0.8|||||||Chi-squared|||Adverse events in ED||||0.8
72347567|NCT02519595|144216709|SUPERIORITY_OR_OTHER|||||||0.5|||||||Chi-squared|||Post discharge Emesis||||0.5
72347568|NCT02519595|144216710|SUPERIORITY_OR_OTHER|||||||0.011|||||||Chi-squared|||||||0.011
72347569|NCT00387036|144216711|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.92|STANDARD_ERROR_OF_MEAN|0.37||||90.0|-1.59|-0.25||||||||-0.25|-1.59|
72347570|NCT00387036|144216712|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.17|STANDARD_ERROR_OF_MEAN|1.9||||90.0|-0.28|6.61||||||||6.61|-0.28|
72347571|NCT03139344|144216713|SUPERIORITY||||||<|0.001|||||||ANOVA|||||||<0.001
72347572|NCT03139344|144216713|SUPERIORITY||||||<|0.001|||||||ANOVA|||||||<0.001
72347573|NCT03139344|144216714|SUPERIORITY||||||<|0.001|||||||ANOVA|||||||<0.001
72347574|NCT03139344|144216714|SUPERIORITY||||||<|0.001|||||||ANOVA|||||||<0.001
72347575|NCT03139344|144216715|SUPERIORITY|||||||0.011|||||||ANOVA|||||||0.011
72347576|NCT03139344|144216715|SUPERIORITY||||||<|0.001|||||||ANOVA|||||||<0.001
72347577|NCT03139344|144216716|SUPERIORITY|||||||0.148|||||||ANOVA|||||||0.148
72347578|NCT03139344|144216716|SUPERIORITY|||||||0.005|||||||ANOVA|||||||0.005
72347579|NCT03139344|144216717|SUPERIORITY|||||||0.069|||||||ANOVA|||||||0.069
72347580|NCT03139344|144216717|SUPERIORITY|||||||0.003|||||||ANOVA|||||||0.003
72429068|NCT00050089|144369066|SUPERIORITY_OR_OTHER|||||||0.87|TWO_SIDED||||||Log Rank|||Stratified Log-rank test was used to compare the four treatment||||0.87
72347581|NCT03139344|144216718|SUPERIORITY|||||||0.118|||||||ANOVA|||||||0.118
72347582|NCT03139344|144216718|SUPERIORITY|||||||0.01|||||||ANOVA|||||||0.010
72347583|NCT03139344|144216719|SUPERIORITY|||||||0.059|||||||ANOVA|||||||0.059
72347584|NCT03139344|144216719|SUPERIORITY|||||||0.015|||||||ANOVA|||||||0.015
72347585|NCT03139344|144216720|SUPERIORITY|||||||0.01|||||||ANOVA|||||||0.010
72347586|NCT03139344|144216720|SUPERIORITY|||||||0.001|||||||ANOVA|||||||0.001
72347587|NCT03139344|144216721|SUPERIORITY|||||||0.036|||||||t-test, 2 sided|||||||0.036
72347588|NCT03139344|144216722|SUPERIORITY|||||||0.345|||||||t-test, 2 sided|||||||0.345
72347589|NCT03139344|144216723|SUPERIORITY|||||||0.264|||||||t-test, 2 sided|||||||0.264
72347590|NCT03139344|144216724|SUPERIORITY|||||||0.266|||||||t-test, 2 sided|||||||0.266
72347591|NCT03139344|144216725|SUPERIORITY|||||||0.04|||||||t-test, 2 sided|||||||0.040
72347592|NCT03139344|144216726|SUPERIORITY|||||||0.109|||||||t-test, 2 sided|||||||0.109
72347593|NCT03139344|144216727|SUPERIORITY|||||||0.895|||||||t-test, 2 sided|||||||0.895
72347594|NCT03139344|144216728|SUPERIORITY|||||||0.573|||||||t-test, 2 sided|paired t-test||||||0.573
72347595|NCT03139344|144216729|SUPERIORITY|||||||0.858|||||||t-test, 2 sided|paired t-test||||||0.858
72347596|NCT03188510|144216730|OTHER||Ratio of geometric least squares means|0.971|||||TWO_SIDED|90.0|0.805|1.17||||||||1.17|0.805|
72347597|NCT03188510|144216730|OTHER||Ratio of geometric least squares means|1.01|||||TWO_SIDED|90.0|0.841|1.22||||||||1.22|0.841|
72347598|NCT03188510|144216730|OTHER||Ratio of geometric least squares means|0.985|||||TWO_SIDED|90.0|0.819|1.18||||||||1.18|0.819|
72347599|NCT03188510|144216731|OTHER||Ratio of geometric least squares means|0.978|||||TWO_SIDED|90.0|0.811|1.18||||||||1.18|0.811|
72347600|NCT03188510|144216731|OTHER||Ratio of geometric least squares means|1.0|||||TWO_SIDED|90.0|0.833|1.21||||||||1.21|0.833|
72347601|NCT03188510|144216731|OTHER||Ratio of geometric least squares means|0.982|||||TWO_SIDED|90.0|0.817|1.18||||||||1.18|0.817|
72347602|NCT03052049|144216735|OTHER|t-test|p value|0.05||||0.05|TWO_SIDED|0.0||||P value was calculated with threshold of significance \<0.05.|t-test, 2 sided||P value was calculated with threshold of significance \<0.05.|||||0.05
72347603|NCT03052049|144216736|OTHER|||||||0.05||||||P value was calculated and a value of \<0.05 was considered significant.|t-test, 2 sided|||||||0.05
72347604|NCT03052049|144216737|OTHER|||||||0.05||||||P value was calculated and a value of \<0.05 was considered significant.|t-test, 2 sided|||||||0.05
72347605|NCT03052049|144216738|OTHER|||||||0.05||||||P value was calculated and a value of \<0.05 was considered significant.|t-test, 2 sided|||||||0.05
72347606|NCT03052049|144216739|SUPERIORITY|||||||0.05||||||P value was calculated and a value of \<0.05 was considered significant.|t-test, 2 sided|||||||0.05
72347607|NCT00999518|144216740|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.03|||||TWO_SIDED|95.0|-0.4|0.35||||||The 3 parameter E max dose-response model, including baseline as a covariate, was fitted to estimate mean difference (tanezumab minus placebo) and associated 95% confidence interval (CI).||0.35|-0.40|
72347608|NCT00999518|144216740|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.06|||||TWO_SIDED|95.0|-0.8|0.68||||||The 3 parameter E max dose-response model, including baseline as a covariate, was fitted to estimate mean difference (tanezumab minus placebo) and associated 95% CI.||0.68|-0.80|
72347609|NCT00999518|144216740|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.16|||||TWO_SIDED|95.0|-1.15|0.83||||||The 3 parameter E max dose-response model, including baseline as a covariate, was fitted to estimate mean difference (tanezumab minus placebo) and associated 95% CI.||0.83|-1.15|
72347610|NCT00999518|144216740|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.23|||||TWO_SIDED|95.0|-0.93|0.47||||||The 3 parameter E max dose-response model, including baseline as a covariate, was fitted to estimate mean difference (tanezumab minus placebo) and associated 95% CI.||0.47|-0.93|
72347611|NCT00999518|144216742|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.66|||||TWO_SIDED|95.0|0.259|1.683||||||Week 8, at least 30% Reduction: Logistic regression analysis with treatment as independent variable was used for the analysis.||1.683|0.259|
72347612|NCT00999518|144216742|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.975|||||TWO_SIDED|95.0|0.387|2.457||||||Week 8, at least 30% Reduction: Logistic regression analysis with treatment as independent variable was used for the analysis.||2.457|0.387|
72347613|NCT00999518|144216742|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.969|||||TWO_SIDED|95.0|0.392|2.398||||||Week 8, at least 30% Reduction: Logistic regression analysis with treatment as independent variable was used for the analysis.||2.398|0.392|
72347614|NCT00999518|144216742|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.969|||||TWO_SIDED|95.0|0.392|2.398||||||Week 8, at least 30% Reduction: Logistic regression analysis with treatment as independent variable was used for the analysis.||2.398|0.392|
72429069|NCT00050089|144369067|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.008||||0.92|TWO_SIDED|95.0|0.75|1.35|||Log Rank||The comparison was Standard-ART (standard) vs Mega-ART (intensification)|Time-to-event (Kaplan-Meier) and stratified log-rank test was used for the comparison||1.35|0.75|0.92
72347615|NCT00999518|144216742|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.629|||||TWO_SIDED|95.0|0.202|1.96||||||Week 8, at least 50% Reduction: Logistic regression analysis with treatment as independent variable was used for the analysis.||1.960|0.202|
72347616|NCT00999518|144216742|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.179|||||TWO_SIDED|95.0|0.411|3.376||||||Week 8, at least 50% Reduction: Logistic regression analysis with treatment as independent variable was used for the analysis.||3.376|0.411|
72347617|NCT00999518|144216742|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.222|||||TWO_SIDED|95.0|0.438|3.414||||||Week 8, at least 50% Reduction: Logistic regression analysis with treatment as independent variable was used for the analysis.||3.414|0.438|
72347618|NCT00999518|144216742|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.778|||||TWO_SIDED|95.0|0.259|2.335||||||Week 8, at least 50% Reduction: Logistic regression analysis with treatment as independent variable was used for the analysis.||2.335|0.259|
72347619|NCT00999518|144216742|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.929|||||TWO_SIDED|95.0|0.37|2.327||||||Week 16, at least 30% Reduction: Logistic regression analysis with treatment as independent variable was used for the analysis.||2.327|0.370|
72347620|NCT00999518|144216742|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.083|||||TWO_SIDED|95.0|0.427|2.749||||||Week 16, at least 30% Reduction: Logistic regression analysis with treatment as independent variable was used for the analysis.||2.749|0.427|
72347621|NCT00999518|144216742|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.759|||||TWO_SIDED|95.0|0.295|1.952||||||Week 16, at least 30% Reduction: Logistic regression analysis with treatment as independent variable was used for the analysis.||1.952|0.295|
72347622|NCT00999518|144216742|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.759|||||TWO_SIDED|95.0|0.295|1.952||||||Week 16, at least 30% Reduction: Logistic regression analysis with treatment as independent variable was used for the analysis.||1.952|0.295|
72347623|NCT00999518|144216742|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.875|||||TWO_SIDED|95.0|0.285|2.682||||||Week 16, at least 50% Reduction: Logistic regression analysis with treatment as independent variable was used for the analysis.||2.682|0.285|
72347624|NCT00999518|144216742|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.366|||||TWO_SIDED|95.0|0.466|4.006||||||Week 16, at least 50% Reduction: Logistic regression analysis with treatment as independent variable was used for the analysis.||4.006|0.466|
72347625|NCT00999518|144216742|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.75|||||TWO_SIDED|95.0|0.235|2.394||||||Week 16, at least 50% Reduction: Logistic regression analysis with treatment as independent variable was used for the analysis.||2.394|0.235|
72347626|NCT00999518|144216742|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.063|||||TWO_SIDED|95.0|0.356|3.168||||||Week 16, at least 50% Reduction: Logistic regression analysis with treatment as independent variable was used for the analysis.||3.168|0.356|
72347627|NCT00999518|144216745|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.263||||0.5731|TWO_SIDED|95.0|0.56|2.848|||Regression, Logistic|||Week 8: Proportional odds logistic regression analysis with treatment as independent variable was used for the analysis.||2.848|0.560|0.5731
72347628|NCT00999518|144216745|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.656||||0.2592|TWO_SIDED|95.0|0.689|3.98|||Regression, Logistic|||Week 8: Proportional odds logistic regression analysis with treatment as independent variable was used for the analysis.||3.980|0.689|0.2592
72347629|NCT00999518|144216745|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.9181||||1.045|TWO_SIDED|95.0|0.452|2.417|||Regression, Logistic|||Week 8: Proportional odds logistic regression analysis with treatment as independent variable was used for the analysis.||2.417|0.452|1.045
72429070|NCT00050089|144369068|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.08||||0.68|TWO_SIDED|95.0|0.8|1.46|||Log Rank||The comparison was ARDFP (interruption) vs No ARDFP (continuation) of ART|Time-to-event (Kaplan-Meier) and stratified log-rank test was used for the comparison.||1.46|0.8|0.68
72347630|NCT00999518|144216745|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.306||||0.5289|TWO_SIDED|95.0|0.569|2.997|||Regression, Logistic|||Week 8: Proportional odds logistic regression analysis with treatment as independent variable was used for the analysis.||2.997|0.569|0.5289
72347631|NCT00999518|144216745|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.893||||0.793|TWO_SIDED|95.0|0.385|2.074|||Regression, Logistic|||Week 16: Proportional odds logistic regression analysis with treatment as independent variable was used for the analysis. For Week 16, data scores were combined into 3 categories: Improved ('slightly improved', 'moderately improved', 'markedly improved'), No Change ('no change') and Worse ('markedly worse', 'moderately worse', 'slightly worse') for comparison.||2.074|0.385|0.7930
72347632|NCT00999518|144216745|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.167||||0.7386|TWO_SIDED|95.0|0.471|2.892|||Regression, Logistic|||Week 16: Proportional odds logistic regression analysis with treatment as independent variable was used for the analysis. For Week 16, data scores were combined into 3 categories: Improved ('slightly improved', 'moderately improved', 'markedly improved'), No Change ('no change') and Worse ('markedly worse', 'moderately worse', 'slightly worse') for comparison.||2.892|0.471|0.7386
72347633|NCT00999518|144216745|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.036||||0.9354|TWO_SIDED|95.0|0.437|2.46|||Regression, Logistic|||Week 16: Proportional odds logistic regression analysis with treatment as independent variable was used for the analysis. For Week 16, data scores were combined into 3 categories: Improved ('slightly improved', 'moderately improved', 'markedly improved'), No Change ('no change') and Worse ('markedly worse', 'moderately worse', 'slightly worse') for comparison.||2.460|0.437|0.9354
72347634|NCT00999518|144216745|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.805||||0.6207|TWO_SIDED|95.0|0.341|1.899|||Regression, Logistic|||Week 16: Proportional odds logistic regression analysis with treatment as independent variable was used for the analysis. For Week 16, data scores were combined into 3 categories: Improved ('slightly improved', 'moderately improved', 'markedly improved'), No Change ('no change') and Worse ('markedly worse', 'moderately worse', 'slightly worse') for comparison.||1.899|0.341|0.6207
72347635|NCT00122369|144216777|SUPERIORITY_OR_OTHER|||||||0.014||95.0||||Bonferoni correction was made so that results with p\<0.0167 are considered significant|t-test, 2 sided|||The impact of knowing or not knowing the diagnosis became so overwhelming and group composition with regard of whether and which result had been communicated changed daily in the post-biopsy follow-up, so that the originally planned analysis of the impact of Self-Hynotic Relaxation or Empathic Attention on cortisol measures became underpowered. Therefore we focused on the analysis of the impact of diagnosis.||||0.014
72347636|NCT00122369|144216777|SUPERIORITY_OR_OTHER|||||||0.421||95.0||||Bonferoni correction was made so that results with p\<0.0167 are considered significant.|t-test, 2 sided|||||||0.421
72429071|NCT04039503|144369069|SUPERIORITY||LS Mean Difference|-1.66|||<|0.001|TWO_SIDED|95.0|-1.88|-1.43|||Mixed Models Analysis|||||-1.43|-1.88|<0.001
72347637|NCT00122369|144216777|SUPERIORITY_OR_OTHER|||||||0.138||95.0||||Bonferoni correction was made so that results with p\<0.0167 are considered significant.|t-test, 2 sided|||||||0.138
72347638|NCT00122369|144216778|SUPERIORITY_OR_OTHER|||||||0.56|||||||ANOVA|||The null-hypothesis was that there would be no difference among groups.||||0.56
72347639|NCT00122369|144216790|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Ordinal regression|||||||<0.001
72347640|NCT00122369|144216790|SUPERIORITY_OR_OTHER|||||||0.45||95.0|||||Ordinal regression|||||||0.45
72347641|NCT00122369|144216790|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Ordinal regression|||||||<0.001
72347642|NCT00122369|144216790|SUPERIORITY_OR_OTHER||||||<|0.01||95.0|||||Proportional odds model|||||||<0.01
72347643|NCT00122369|144216790|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Proportional odds model|||||||<0.001
72347644|NCT00122369|144216790|SUPERIORITY_OR_OTHER||||||<|0.01||95.0|||||Proportional odds model|||||||<0.01
72347645|NCT00122369|144216803|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Ordinal regression|||||||<0.001
72347646|NCT00122369|144216803|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Ordinal regression|||||||<0.001
72347647|NCT00122369|144216803|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Ordinal regression|||||||<0.001
72347648|NCT00122369|144216803|SUPERIORITY_OR_OTHER|||||||0.024||95.0|||||Proportional odds model|||||||0.024
72347649|NCT00122369|144216803|SUPERIORITY_OR_OTHER|||||||0.018||95.0|||||Proportional odds model|||||||0.018
72347650|NCT00122369|144216803|SUPERIORITY_OR_OTHER|||||||0.73||95.0|||||Proportional odds model|||||||0.73
72347651|NCT04254666|144216824|OTHER||||||||||||||||||pre and post scores for this measure are presented as the percent of foods correctly classified.|||
72347652|NCT03688074|144216840|OTHER||Ratio of Geometric LSMeans|0.15|||<|0.001|TWO_SIDED|90.0|0.06|0.35||Nominal p-values were reported. No adjustment of multiplicity was performed.|ANCOVA|Model includes treatment+log transformed baseline value+stratification factor (screening eos count \[\<150, 150-\<300, \>=300 cells/uL\])|Parameter : Eosinophils (cells/mm\^2)||95% CI (0.05, 0.41)|0.35|0.06|<0.001
72347653|NCT03688074|144216840|OTHER||Ratio of Geometric LSMeans|1.36||||0.106|TWO_SIDED|90.0|0.99|1.86||Nominal p-values were reported. No adjustment of multiplicity was performed.|ANCOVA|Model includes treatment+log transformed baseline value+stratification factor (screening eos count \[\<150, 150-\<300, \>=300 cells/uL\])|Parameter: Neutrophils (cells/mm\^2)||95% CI (0.94, 1.97)|1.86|0.99|0.106
72347654|NCT03688074|144216840|OTHER||Ratio of Geometric LSMeans|1.12||||0.389|TWO_SIDED|90.0|0.9|1.4||Nominal p-values were reported. No adjustment of multiplicity was performed.|ANCOVA|Model includes treatment+log transformed baseline value+stratification factor (screening eos count \[\<150, 150-\<300, \>=300 cells/uL\])|Parameter: T cells CD3+ (cells/mm\^2)||95% CI (0.86, 1.46)|1.40|0.90|0.389
72347655|NCT03688074|144216840|OTHER||Ratio of Geometric LSMeans|1.18||||0.216|TWO_SIDED|90.0|0.94|1.48||Nominal p-values were reported. No adjustment of multiplicity was performed.|ANCOVA|Model includes treatment+log transformed baseline value+stratification factor (screening eos count \[\<150, 150-\<300, \>=300 cells/uL\])|Parameter: T cells CD4+ (cells/mm\^2)||95% CI (0.90, 1.55)|1.48|0.94|0.216
72347656|NCT03688074|144216840|OTHER||Ratio of Geometric LSMeans|0.83||||0.26|TWO_SIDED|90.0|0.64|1.09||Nominal p-values were reported. No adjustment of multiplicity was performed.|ANCOVA|Model includes treatment+log transformed baseline value+stratification factor (screening eos count \[\<150, 150-\<300, \>=300 cells/uL\])|Parameter: Mast cells Tryptase+ (cells/mm\^2)||95% CI (0.61, 1.15)|1.09|0.64|0.260
72347657|NCT03688074|144216840|OTHER||Ratio of Geometric LSMeans|1.19||||0.546|TWO_SIDED|90.0|0.74|1.92||Nominal p-values were reported. No adjustment of multiplicity was performed.|ANCOVA|Model includes treatment+log transformed baseline value+stratification factor (screening eos count \[\<150, 150-\<300, \>=300 cells/uL\])|Parameter: Mast cells Chymase+ (cells/mm\^2)||95% CI (0.67, 2.10)|1.92|0.74|0.546
72347658|NCT01128244|144216844|SUPERIORITY_OR_OTHER|||||||0.2|TWO_SIDED|||||Threshold for significance P\<0.05|t-test, 2 sided|Paired t-test||||||0.20
72347659|NCT01128244|144216845|SUPERIORITY_OR_OTHER|||||||0.62|TWO_SIDED|||||Threshold for significance, P\<0.05|t-test, 2 sided|Paired t-test||||||0.62
72347660|NCT01128244|144216846|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Threshold for significance, P\<0.05|t-test, 2 sided|Paired t-test||||||<0.001
72347661|NCT01128244|144216847|SUPERIORITY_OR_OTHER|||||||0.45|TWO_SIDED|||||Threshold for significance, P\<0.05|t-test, 2 sided|Paired t-test||||||0.45
72347662|NCT01128244|144216848|SUPERIORITY_OR_OTHER||Test of treatment effect.|0.05|||<|0.05|TWO_SIDED|||||Data were analyzed by paired t-test adjusted for multiple testing by Sidak methods.|t-test, 2 sided|||Data were analyzed by paired t-test adjusted for multiple testing by Sidak methods.||||<0.05
72347663|NCT02219334|144216849|EQUIVALENCE|Historical data at the institution for similar patients had a mean length of stay(LOS) of 25.7 hours (standard deviation-\[SD\] =10.3) from 9/2012- 9/13 was observed for 134 patients admitted to the emergency department observation unit and treated with the standard of care (NeoSucker). Given a LOS-SD of 10.3 hours, 75 subjects per treatment group would provide 80% statistical power at the 5% significance level to demonstrate equivalence in the two treatments' length of stay within ±5 hours.|Mean Difference (Final Values)|2.49|STANDARD_DEVIATION|21.4|<|0.05|TWO_SIDED|95.0|-10.74|15.72|||two one-sided t-test (TOST)||Due to slower than anticipated patient recruitment, the target size of 75 participants per treatment group was not reached.|The primary hypothesis of length of stay equivalence within a margin of ± 5 hours was tested using the two one-sided t-test (TOST) procedure, with a 5% significance level.||15.72|-10.74|<0.05
72347664|NCT06292130|144216853|OTHER|||||||0.17|||||||t-test, 2 sided|||||||0.17
72347665|NCT06292130|144216854|OTHER|||||||0.006|||||||t-test, 2 sided|||||||0.006
72347666|NCT02206035|144216856|SUPERIORITY|||||||0.95|||||||t-test, 2 sided|||Comparison at Baseline||||0.95
72347667|NCT02206035|144216856|SUPERIORITY|||||||0.26|||||||t-test, 2 sided|||Comparison at Day 28||||0.26
72347668|NCT02206035|144216856|SUPERIORITY|||||||0.63|||||||t-test, 2 sided|||Comparison at Day 100||||0.63
72347669|NCT02206035|144216856|SUPERIORITY|||||||0.76|||||||t-test, 2 sided|||Comparison at Day 180||||0.76
72347670|NCT02206035|144216857|SUPERIORITY|||||||0.99|||||||t-test, 2 sided|||Comparison at Baseline||||0.99
72347671|NCT02206035|144216857|SUPERIORITY|||||||0.48|||||||t-test, 2 sided|||Comparison at Day 28||||0.48
72347672|NCT02206035|144216857|SUPERIORITY|||||||0.35|||||||t-test, 2 sided|||||||0.35
72347673|NCT02206035|144216857|SUPERIORITY|||||||0.96|||||||t-test, 2 sided|||Comparison at Day 180||||0.96
72347674|NCT02206035|144216858|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||Comparison at Baseline||||<0.001
72347675|NCT02206035|144216858|SUPERIORITY|||||||0.75|||||||t-test, 2 sided|||Comparison at Day 28||||0.75
72347676|NCT02206035|144216858|SUPERIORITY|||||||0.28|||||||t-test, 2 sided|||Comparison at Day 100||||0.28
72347677|NCT02206035|144216858|SUPERIORITY|||||||0.82|||||||t-test, 2 sided|||Comparison at Day 180||||0.82
72347678|NCT02206035|144216859|SUPERIORITY|||||||0.54|||||||t-test, 2 sided|||Comparison at Baseline||||0.54
72347679|NCT02206035|144216859|SUPERIORITY|||||||0.61|||||||t-test, 2 sided|||Comparison at Day 28||||0.61
72347680|NCT02206035|144216859|SUPERIORITY|||||||0.42|||||||t-test, 2 sided|||Comparison at Day 100||||0.42
72347681|NCT02206035|144216859|SUPERIORITY|||||||0.38|||||||t-test, 2 sided|||Comparison at Day 180||||0.38
72347682|NCT02206035|144216860|SUPERIORITY|||||||0.1|||||||t-test, 2 sided|||Comparison at Baseline||||0.10
72347683|NCT02206035|144216860|SUPERIORITY|||||||0.32|||||||t-test, 2 sided|||Comparison at Day 28||||0.32
72347684|NCT02206035|144216860|SUPERIORITY|||||||0.63|||||||t-test, 2 sided|||Comparison at Day 100||||0.63
72347685|NCT02206035|144216860|SUPERIORITY|||||||0.3|||||||t-test, 2 sided|||Comparison at Day 180||||0.30
72347686|NCT01934010|144216861|SUPERIORITY|||||||0.128|||||||Fisher Exact|||Fisher's exact test to assess if there is a difference in deterioration of hearing threshold between subjects that received 1 treatment cycle with AM-101 or others who received 2 treatment cycles.||||0.128
72347687|NCT01934010|144216861|SUPERIORITY|||||||0.075|||||||Fisher Exact|||Fisher's exact test to assess if there is a difference in deterioration of hearing threshold between subjects that received 1 treatment cycle with AM-101 or others who received 3 treatment cycles.||||0.075
72347688|NCT01934010|144216861|SUPERIORITY|||||||1|||||||Fisher Exact|||Fisher's exact test to assess if there is a difference in deterioration of hearing threshold between subjects that received 2 treatment cycles with AM-101 or others who received 3 treatment cycles.||||1
72347689|NCT01934010|144216862|SUPERIORITY|||||||0.4403|||||||Fisher Exact|||||||0.4403
72347690|NCT01934010|144216864|SUPERIORITY|||||||0.2401|||||||Fisher Exact|||||||0.2401
72347691|NCT01934010|144216864|SUPERIORITY|||||||0.0022|||||||Fisher Exact|||||||0.0022
72347692|NCT01934010|144216864|SUPERIORITY|||||||0.1001|||||||Fisher Exact|||||||0.1001
72347693|NCT01934010|144216865|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.0
72347694|NCT01393821|144216867|SUPERIORITY|||||||0.6311|||||||Kruskal-Wallis|||||||0.6311
72347695|NCT00939562|144216893|SUPERIORITY_OR_OTHER||Ratio|102.95||||||90.0|94.74|111.86|||||The adjusted mean differences and 90% confidence intervals (CIs) were exponentiated to provide the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. Doxycycline carragenate=Reference, doxycycline monohydrate=Test.|Natural log transformed Cmax was analyzed using a mixed effects model (sequence, period and treatment were fixed effects and subject within sequence was a random effect).||111.86|94.74|
72347696|NCT00939562|144216894|SUPERIORITY_OR_OTHER||Ratio|104.67||||||90.0|98.95|110.73|||||The adjusted mean differences and 90% CIs were exponentiated to provide the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. Doxycycline carragenate=Reference, doxycycline monohydrate=Test.|Natural log transformed AUCinf was analyzed using a mixed effects model (sequence, period and treatment were fixed effects and subject within sequence was a random effect).||110.73|98.95|
72347697|NCT04531241|144216910|NON_INFERIORITY|It was calculated that 120 participants randomized in a 1:1 fashion between the two sequences would have at least 80% power to detect a 5 points difference in mean overall comfort and vision at the 1-week follow-up. Sample size was determined using Stroup's Method (alpha=0.05). A non-inferiority margin of -5 points was used.|Least-Square Mean Difference|-2.9|STANDARD_ERROR_OF_MEAN|2.01|||TWO_SIDED|95.0|-6.8|1.1|||Mixed Models Analysis|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.|Mean difference was calculated as Test - Control|||1.1|-6.8|
72347698|NCT04531241|144216911|NON_INFERIORITY|It was calculated that 120 participants randomized in a 1:1 fashion between the two sequences would have a 0.05 logMAR unit difference in logMAR visual acuity at LLHC and HLLC lighting conditions at the 1-week follow-up. Sample size was determined using Stroup's Method (alpha=0.05). A non-inferiority margin of 0.05 logMAR units was used.|Least-Square Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.005|||TWO_SIDED|95.0|-0.0199|0.0|||Mixed Models Analysis|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.|Mean difference was calculated as Test - Control|Low Luminance High Contrast||0.0|-0.0199|
72347699|NCT04531241|144216911|NON_INFERIORITY|It was calculated that 120 participants randomized in a 1:1 fashion between the two sequences would have a 0.05 logMAR unit difference in logMAR visual acuity at LLHC and HLLC lighting conditions at the 1-week follow-up. Sample size was determined using Stroup's Method (alpha=0.05). A non-inferiority margin of 0.05 logMAR units was used.|Least-Square Mean Difference|-0.004|STANDARD_ERROR_OF_MEAN|0.0066|||TWO_SIDED|95.0|-0.0173|0.0087|||Mixed Model Analysis|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.|Mean difference was calculated as Test - Control|High Luminance Low Contrast||0.0087|-0.0173|
72347700|NCT04531241|144216912|NON_INFERIORITY|It was calculated that 120 participants randomized in a 1:1 fashion between the two sequences would have a 1 hour difference in average daily wear time at the 1-week follow-up. Sample size was determined using Stroup's Method (alpha=0.05). A non-inferiority margin of 1 hour was used.|Least-Square Mean Difference|-0.052|STANDARD_ERROR_OF_MEAN|0.0731|||TWO_SIDED|95.0|-0.1968|0.0933|||Mixed Models Analysis|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.|Mean difference was calculated as Test - Control|||0.0933|-0.1968|
72347701|NCT04531241|144216913|NON_INFERIORITY|It was calculated that 120 participants randomized in a 1:1 fashion between the two sequences would have at least 80% power to detect a 5 points difference in mean overall comfort and vision at the 1-week follow-up. Sample size was determined using Stroup's Method (alpha=0.05). A non-inferiority margin of -5 points was used.|Least-Square Mean Difference|-2.6|STANDARD_ERROR_OF_MEAN|1.47|||TWO_SIDED|95.0|-5.5|0.3|||Mixed Models Analysis|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.|Mean difference was calculated as Test - Control|||0.3|-5.5|
72347702|NCT04929249|144216914|SUPERIORITY||LS mean difference|-53.0|||<|0.001|TWO_SIDED|97.5|-60.0|-46.0|||Mixed Models Analysis|||||-46.0|-60.0|<0.001
72347703|NCT04929249|144216915|NON_INFERIORITY|Non-inferiority was declared if the upper limit of the one-sided 98.75% confidence interval did not exceed the non-inferiority margin of 15%.|Difference in percentage|-10.6|||||TWO_SIDED|97.5|-18.3|-3.0|||Normal approx. to binomial distribution||||Upper limit of one-sided 98.75% CI (-3.0%)|-3.0|-18.3|
72347704|NCT04929249|144216916|SUPERIORITY||LS mean difference|-47.6|||<|0.001|TWO_SIDED|95.0|-52.8|-42.3|||Mixed Models Analysis|||||-42.3|-52.8|<0.001
72347705|NCT04929249|144216917|SUPERIORITY||LS mean difference|-54.4|||<|0.001|TWO_SIDED|95.0|-59.0|-49.8|||Regression, Linear|||||-49.8|-59.0|<0.001
72347706|NCT04929249|144216918|SUPERIORITY||LS mean difference|-48.9|||<|0.001|TWO_SIDED|95.0|-52.9|-44.9|||Regression, Linear|||||-44.9|-52.9|<0.001
72347707|NCT04929249|144216919|SUPERIORITY||Odds Ratio (OR)|42.32|||<|0.001|TWO_SIDED|95.0|22.07|81.16|||Regression, Logistic|||||81.16|22.07|<0.001
72347708|NCT04929249|144216920|SUPERIORITY||Odds Ratio (OR)|17.32|||<|0.001|TWO_SIDED|95.0|6.72|44.66|||Regression, Logistic|||||44.66|6.72|<0.001
72347709|NCT04929249|144216921|SUPERIORITY||Odds Ratio (OR)|24.46|||<|0.001|TWO_SIDED|95.0|14.18|42.19|||Regression, Logistic|||||42.19|14.18|<0.001
72347710|NCT04929249|144216922|SUPERIORITY||Odds Ratio (OR)|35.12|||<|0.001|TWO_SIDED|95.0|19.51|63.24|||Regression, Logistic|||||63.24|19.51|<0.001
72347711|NCT04929249|144216923|SUPERIORITY||LS mean difference|-30.1|||<|0.001|TWO_SIDED|95.0|-33.8|-26.3|||Mixed Models Analysis|||Total Cholesterol||-26.3|-33.8|<0.001
72347712|NCT04929249|144216923|SUPERIORITY||LS mean difference|6.6|||<|0.001|TWO_SIDED|95.0|3.6|9.5|||Mixed Models Analysis|||HDL Cholesterol||9.5|3.6|<0.001
72347713|NCT04929249|144216923|SUPERIORITY||LS mean difference|-44.2|||<|0.001|TWO_SIDED|95.0|-49.1|-39.3|||Mixed Models Analysis|||Non-HDL Cholesterol||-39.3|-49.1|<0.001
72347714|NCT04929249|144216923|SUPERIORITY||LS mean difference|-16.9|||<|0.001|TWO_SIDED|95.0|-23.8|-10.0|||Mixed Models Analysis|||VLDL Cholesterol||-10.0|-23.8|<0.001
72347715|NCT04929249|144216923|SUPERIORITY||LS mean difference|-17.8|||<|0.001|TWO_SIDED|95.0|-24.7|-10.9|||Mixed Models Analysis|||Triglycerides||-10.9|-24.7|<0.001
72347716|NCT04929249|144216923|SUPERIORITY||LS mean difference|-42.6|||<|0.001|TWO_SIDED|95.0|-47.5|-37.8|||Mixed Models Analysis|||Apolipoprotein B||-37.8|-47.5|<0.001
72347717|NCT04929249|144216923|SUPERIORITY||LS mean difference|-21.9|||<|0.001|TWO_SIDED|95.0|-25.8|-18.0|||Mixed Models Analysis|||Lipoprotein(a)||-18.0|-25.8|<0.001
72347718|NCT04929249|144216924|SUPERIORITY||LS mean difference|-49.9|||<|0.001|TWO_SIDED|95.0|-56.0|-43.9|||Mixed Models Analysis|||Total Cholesterol||-43.9|-56.0|<0.001
72347719|NCT04929249|144216924|SUPERIORITY||LS mean difference|3.1|||<|0.001|TWO_SIDED|95.0|1.8|4.4|||Mixed Models Analysis|||HDL Cholesterol||4.4|1.8|<0.001
72347720|NCT04929249|144216924|SUPERIORITY||LS mean difference|-52.4|||<|0.001|TWO_SIDED|95.0|-58.1|-46.7|||Mixed Models Analysis|||Non-HDL Cholesterol||-46.7|-58.1|<0.001
72347721|NCT04929249|144216924|SUPERIORITY||LS mean difference|-4.6|||<|0.001|TWO_SIDED|95.0|-6.5|-2.8|||Mixed Models Analysis|||VLDL Cholesterol||-2.8|-6.5|<0.001
72347722|NCT04929249|144216924|SUPERIORITY||LS mean difference|-25.3|||<|0.001|TWO_SIDED|95.0|-34.8|-15.8|||Mixed Models Analysis|||Triglycerides||-15.8|-34.8|<0.001
72347723|NCT04929249|144216924|SUPERIORITY||LS mean difference|-36.3|||<|0.001|TWO_SIDED|95.0|-39.7|-32.9|||Mixed Models Analysis|||Apolipoprotein B||-32.9|-39.7|<0.001
72347724|NCT04929249|144216924|SUPERIORITY||LS mean difference|-8.7|||<|0.001|TWO_SIDED|95.0|-10.7|-6.8|||Mixed Models Analysis|||Lipoprotein(a)||-6.8|-10.7|<0.001
72347725|NCT04929249|144216925|SUPERIORITY||Odds Ratio (OR)|1.06||||0.899|TWO_SIDED|95.0|0.43|2.61|||proportional odds model|||||2.61|0.43|0.899
72347726|NCT04929249|144216926|SUPERIORITY||LS mean difference|-0.008||||0.727|TWO_SIDED|95.0|-0.055|0.039|||Regression, Linear|||||0.039|-0.055|0.727
72347727|NCT02211456|144216935|SUPERIORITY||Mean Difference (Final Values)|3.7|||<|0.05|TWO_SIDED|95.0|1.0|6.3|||Mixed Models Analysis|||The data derived from this study was complex multi-level data with errors due to patient-level and intra-patient repeat factors. Accordingly, we used generalized multi-level modelling (GLMM) with random effects.||6.3|1|<0.05
72347728|NCT02910102|144216953|SUPERIORITY||Mean Difference (Final Values)|-1.9||||0.3565|TWO_SIDED|95.0|-6.04|2.23||The threshold for statistical significance was p=0.05|Mixed Models Analysis|Each co-primary endpoint was tested at two-sided 5% level of significance, with no adjustments for multiplicity.||||2.23|-6.04|0.3565
72347729|NCT02910102|144216954|SUPERIORITY||Mean Difference (Final Values)|-0.17||||0.922|TWO_SIDED|95.0|-3.73|3.38||The threshold for statistical significance was p=0.05|Mixed Models Analysis|Each co-primary endpoint was tested at two-sided 5% level of significance, with no adjustments for multiplicity.||||3.38|-3.73|0.9220
72347730|NCT00095173|144216955|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.31||||0.0002|TWO_SIDED|95.0|0.16|0.59|||Log Rank||Abatacept over placebo|||0.59|0.16|0.0002
72347731|NCT00095173|144216956|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Chi-squared|||||||<0.001
72347732|NCT02578186|144216981|SUPERIORITY_OR_OTHER|||||||0.0312|||||||ANCOVA|||||||0.0312
72347733|NCT02708355|144216994|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.028||||0.0442|TWO_SIDED|95.0|1.001|1.055|||Regression, Logistic|||Association between percentage of time with intragastric pH\>4 and relief of 24 -hour heartburn was assessed using logistic regression model with relief of 24- hour heartburn at Day 14 as dependent variable and change in percentage of time with intragastric pH\>4 as the independent variable, controlling for age, sex, and body mass index (BMI).||1.055|1.001|0.0442
72347734|NCT01320202|144216995|SUPERIORITY_OR_OTHER||Difference in LS Means between SFP & PBO|3.6|STANDARD_ERROR_OF_MEAN|1.4||0.011|TWO_SIDED|||||LS Mean (SE) and p-value are from ANCOVA model with baseline Hgb as covariate. Model also includes indicator variable for baseline ESA dose stratum.|ANCOVA|||||||0.011
72347735|NCT00635882|144217010|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||ANCOVA|||"Analysis of covariance (ANCOVA) model with treatment and baseline eNO as a covariate was used.~Standard deviation is a Pooled Standard deviation from ANCOVA Model with treatment effect and baseline eNO as a covariate."||||<0.001
72347736|NCT00635882|144217010|SUPERIORITY_OR_OTHER_LEGACY|||||||0.003|||||||ANCOVA|||"ANCOVA model with treatment and baseline eNO as a covariate was used.~Standard deviation is a Pooled Standard deviation from ANCOVA Model with treatment effect and baseline eNO as a covariate."||||0.003
72347737|NCT00635882|144217010|SUPERIORITY_OR_OTHER_LEGACY|||||||0.018|||||||ANCOVA|||"ANCOVA model with treatment and baseline eNO as a covariate was used.~Standard deviation is a Pooled Standard deviation from ANCOVA Model with treatment effect and baseline eNO as a covariate."||||0.018
72347738|NCT00635882|144217011|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||ANCOVA|||"ANCOVA model with treatment and baseline eNO as a covariate was used.~Standard deviation is a Pooled Standard deviation from ANCOVA Model with treatment effect and baseline eNO as a covariate."||||<0.001
72347739|NCT00635882|144217011|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002|||||||ANCOVA|||"ANCOVA model with treatment and baseline eNO as a covariate was used.~Standard deviation is a Pooled Standard deviation from ANCOVA Model with treatment effect and baseline eNO as a covariate."||||0.002
72347740|NCT00635882|144217011|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002|||||||ANCOVA|||"ANCOVA model with treatment and baseline eNO as a covariate was used.~Standard deviation is a Pooled Standard deviation from ANCOVA Model with treatment effect and baseline eNO as a covariate."||||0.002
72347741|NCT00635882|144217012|SUPERIORITY_OR_OTHER_LEGACY|||||||0.024|||||||ANCOVA|||"ANCOVA model with treatment and baseline eosinophils as a covariate was used.~Standard deviation is a Pooled Standard deviation from ANCOVA Model with treatment effect and baseline EOS as a covariate."||||0.024
72347742|NCT00635882|144217012|SUPERIORITY_OR_OTHER_LEGACY|||||||0.051|||||||ANCOVA|||"ANCOVA model with treatment and baseline eosinophils as a covariate was used.~Standard deviation is a Pooled Standard deviation from ANCOVA Model with treatment effect and baseline EOS as a covariate."||||0.051
72347743|NCT00635882|144217012|SUPERIORITY_OR_OTHER_LEGACY|||||||0.336|||||||ANCOVA|||"ANCOVA model with treatment and baseline eosinophils as a covariate was used.~Standard deviation is a Pooled Standard deviation from ANCOVA Model with treatment effect and baseline EOS as a covariate."||||0.336
72347744|NCT00635882|144217013|SUPERIORITY_OR_OTHER_LEGACY|||||||0.12|||||||ANCOVA|Analysis applies to Mean Change from Baseline to Day 15.||"ANCOVA model with treatment and baseline PD15 as a covariate was used.~Standard deviation is a Pooled Standard deviation from ANCOVA Model with treatment effect and baseline PD15 as a covariate."||||0.120
72347745|NCT00635882|144217013|SUPERIORITY_OR_OTHER_LEGACY|||||||0.103|||||||ANCOVA|Analysis applies to Mean Change from Baseline to Day 15.||"ANCOVA model with treatment and baseline PD15 as a covariate was used.~Standard deviation is a Pooled Standard deviation from ANCOVA Model with treatment effect and baseline PD15 as a covariate."||||0.103
72347746|NCT00635882|144217013|SUPERIORITY_OR_OTHER_LEGACY|||||||0.048|||||||ANCOVA|Analysis applies to Mean Change from Baseline to Day 15.||"ANCOVA model with treatment and baseline PD15 as a covariate was used.~Standard deviation is a Pooled Standard deviation from ANCOVA Model with treatment effect and baseline PD15 as a covariate."||||0.048
72347747|NCT00635882|144217014|SUPERIORITY_OR_OTHER_LEGACY|||||||0.018|||||||ANOVA|Analysis applies to Mean Change from Baseline to Days 2-15.||"One-way analysis of variance (ANOVA) model with treatment effect was used.~Standard deviation is a Pooled Standard deviation from the one-way ANOVA model with treatment effect."||||0.018
72347748|NCT00635882|144217014|SUPERIORITY_OR_OTHER_LEGACY|||||||0.261|||||||ANOVA|Analysis applies to Mean Change from Baseline to Days 2-15.||"One-way ANOVA model with treatment effect was used.~Standard deviation is a Pooled Standard deviation from the one-way ANOVA model with treatment effect."||||0.261
72347749|NCT00635882|144217014|SUPERIORITY_OR_OTHER_LEGACY|||||||0.334|||||||ANOVA|Analysis applies to Mean Change from Baseline to Days 2-15.||"One-way ANOVA model with treatment effect was used.~Standard deviation is a Pooled Standard deviation from the one-way ANOVA model with treatment effect."||||0.334
72347750|NCT00635882|144217015|SUPERIORITY_OR_OTHER_LEGACY|||||||0.037|||||||ANOVA|Analysis applies to Mean Change from Baseline to Days 1-15.||"One-way ANOVA model with treatment effect was used.~Standard deviation is a Pooled Standard deviation from the one-way ANOVA model with treatment effect."||||0.037
72347751|NCT00635882|144217015|SUPERIORITY_OR_OTHER_LEGACY|||||||0.643|||||||ANOVA|Analysis applies to Mean Change from Baseline to Days 1-15.||"One-way ANOVA model with treatment effect was used.~Standard deviation is a Pooled Standard deviation from the one-way ANOVA model with treatment effect."||||0.643
72347752|NCT00635882|144217015|SUPERIORITY_OR_OTHER_LEGACY|||||||0.963|||||||ANOVA|Analysis applies to Mean Change from Baseline to Days 1-15.||"One-way ANOVA model with treatment effect was used.~Standard deviation is a Pooled Standard deviation from the one-way ANOVA model with treatment effect."||||0.963
72347753|NCT00635882|144217016|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||ANOVA|Analysis applies to Mean Change from Baseline to Days 2-15.||"One-way ANOVA model with treatment effect was used.~Standard deviation is a Pooled Standard deviation from the one-way ANOVA model with treatment effect."||||<0.001
72429072|NCT04039503|144369069|SUPERIORITY||LS Mean Difference|-1.65|||<|0.001|TWO_SIDED|95.0|-1.88|-1.43|||Mixed Models Analysis|||||-1.43|-1.88|<0.001
72347754|NCT00635882|144217016|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002|||||||ANOVA|Analysis applies to Mean Change from Baseline to Days 2-15.||"One-way ANOVA model with treatment effect was used.~Standard deviation is a Pooled Standard deviation from the one-way ANOVA model with treatment effect."||||0.002
72347755|NCT00635882|144217016|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||ANOVA|Analysis applies to Mean Change from Baseline to Days 2-15.||"One-way ANOVA model with treatment effect was used.~Standard deviation is a Pooled Standard deviation from the one-way ANOVA model with treatment effect."||||<0.001
72347756|NCT00635882|144217017|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||ANOVA|Analysis applies to Mean Change from Baseline to Days 1-15.||"One-way ANOVA model with treatment effect was used.~Standard deviation is a Pooled Standard deviation from the one-way ANOVA model with treatment effect."||||<0.001
72347757|NCT00635882|144217017|SUPERIORITY_OR_OTHER_LEGACY|||||||0.057|||||||ANOVA|Analysis applies to Mean Change from Baseline to Days 1-15.||"One-way ANOVA model with treatment effect was used.~Standard deviation is a Pooled Standard deviation from the one-way ANOVA model with treatment effect."||||0.057
72347758|NCT00635882|144217017|SUPERIORITY_OR_OTHER_LEGACY|||||||0.005|||||||ANOVA|Analysis applies to Mean Change from Baseline to Days 1-15.||"One-way ANOVA model with treatment effect was used.~Standard deviation is a Pooled Standard deviation from the one-way ANOVA model with treatment effect."||||0.005
72347759|NCT00483938|144217055|SUPERIORITY_OR_OTHER|||||||0.51|||||||Fisher Exact|||SVR: Group A versus Group B||||0.510
72347760|NCT00483938|144217056|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||SVR: Group C versus Group D||||1.000
72347761|NCT00483938|144217056|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||SVR: Group E versus Group F||||1.000
72347762|NCT00483938|144217057|SUPERIORITY_OR_OTHER|||||||0.792|||||||Fisher Exact|||ETR: Group A versus Group B||||0.792
72347763|NCT00483938|144217057|SUPERIORITY_OR_OTHER|||||||0.612|||||||Fisher Exact|||ETR: Group C versus Group D||||0.612
72347764|NCT00483938|144217057|SUPERIORITY_OR_OTHER|||||||0.49|||||||Fisher Exact|||ETR: Group E versus Group F||||0.490
72347765|NCT00483938|144217057|SUPERIORITY_OR_OTHER|||||||0.363|||||||Fisher Exact|||Complete EVR: Group C versus Group D||||0.363
72429073|NCT04039503|144369070|SUPERIORITY||LS Mean Difference|-1.3|||<|0.001|TWO_SIDED|95.0|-1.52|-1.07|||Mixed Models Analysis|||||-1.07|-1.52|<0.001
72347766|NCT00483938|144217057|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||Complete EVR: Group E versus Group F||||1.000
72347767|NCT02218008|144217058|SUPERIORITY||Least Squares Mean Difference|-1.5||||0.018|TWO_SIDED|95.0|-2.7|-0.3||Hypothesis tests were two-sided with an alpha of 0.05. Control of type 1 error inflation due to multiplicity was achieved by pre-specifying a fixed sequence for statistical tests.|Mixed Models Analysis|ALKS 5461 was compared to pbo using stage-specific MMRM for MADRS-10 Change from Baseline. Model-derived estimates were combined using equal weights.|Estimates below zero favor ALKS 5461.|Analysis was conducted for each stage separately and overall efficacy was based on combined stage analysis where stage-specific estimates were combined using pre-specified equal weights. Within each stage ALKS 5461 2mg/2mg was compared to placebo (i.e., ALKS 5461 2mg/2mg S1 vs Placebo S1; and ALKS 5461 2mg/2mg S2 vs Placebo S2. The pre-specified order of hypothesis tests was ALKS 5461 2/2 compared to placebo followed by ALKS 5461 1/1 compared to placebo.||-0.3|-2.7|0.018
72347768|NCT02218008|144217059|SUPERIORITY|Hypothesis tests were two-sided with an alpha of 0.05. Control of type 1 error inflation due to multiplicity was achieved by pre-specifying a fixed sequence for statistical tests.|Least Squares Mean Difference|-1.9||||0.026|TWO_SIDED|95.0|-3.6|-0.2||ALKS 5461 was compared to pbo using stage-specific MMRM for MADRS-10 Change from Baseline. Model-derived estimates were combined using equal weights.|Mixed Models Analysis||Estimates below zero favor ALKS 5461.|Analysis was conducted for each stage separately and overall efficacy was based on combined stage analysis where stage-specific estimates were combined using pre-specified equal weights. Within each stage ALKS 5461 2mg/2mg was compared to placebo (i.e., ALKS 5461 2mg/2mg S1 vs Placebo S1; and ALKS 5461 2mg/2mg S2 vs Placebo S2. The pre-specified order of hypothesis tests was ALKS 5461 2/2 compared to placebo followed by ALKS 5461 1/1 compared to placebo.||-0.2|-3.6|0.026
72347769|NCT02218008|144217060|SUPERIORITY|The primary hypotheses were evaluated using a 6-step, fixed sequence approach to adjust for multiple comparisons. Using this method, hypothesis testing (using alpha=0.05) continued through the sequence until statistical significance was not achieved. Steps 1-3 included testing the ALKS 5461 2mg/2mg dose vs placebo for the 3 primary endpoints.|Least Squares Mean Difference|-1.7||||0.076|TWO_SIDED|95.0|-3.6|0.2||ALKS 5461 is compared to placebo within each of the 2 stages, and resulting treatment effects from each stage are combined for a single hypothesis test using equal weights of 0.5 for both stages.|Mixed Models Analysis|||ALKS 5461 is compared to placebo within each of the 2 stages (i.e., ALKS 5461 2/2 S1 vs Placebo S1; and ALKS 5461 2/2 S2 vs Placebo S2). Efficacy was estimated as a weighted average across 2 stages using equal weights.||0.2|-3.6|0.076
72347770|NCT02038075|144217064|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|0.38||||0.02|TWO_SIDED|95.0|0.16|0.87|||Regression, Cox|||To determine the effectiveness of brief CBT compared with treatment as usual, univariate and multivariate Cox proportional hazard regression models were used to analyze time to the first suicide attempt. Time to suicide attempt was measured by calculating the total number of days from enrollment to the first suicide attempt. For participants without a suicide attempt, the total number of days from enrollment to the last assessment was calculated.||.87|.16|.02
72347771|NCT00250276|144217134|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The first primary objective was reached as the 95% Confidence Interval (CI) of the GMC ratio between lots was within \[0.5;2\] for the anti-HPV-16 antibodies.|GMC ratio for anti-HPV-16 antibody|1.04|||||TWO_SIDED|95.0|0.81|1.34|||ANOVA|The ANOVA model on the logarithm (log)10 transformation of the concentrations. The ANOVA model included the vaccine group as fixed effect.||To demonstrate lot-to-lot consistency in terms of immunogenicity between the 3 industrial production lots (600L scale) of the Cervarix™ vaccine, one month post dose 3 (Month 7). If consistency was demonstrated the 3 lots would be pooled and non-inferiority of the 600L scale lot vaccine versus the 80L scale would be evaluated as a second primary objective.||1.34|0.81|
72347772|NCT00250276|144217134|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The first primary objective was reached as the 95% CIs of the GMC ratio between lots were within \[0.5;2\] for the anti-HPV-18 antibodies.|GMC ratio for anti-HPV-18 antibody|1.19|||||TWO_SIDED|95.0|0.95|1.49|||ANOVA|The ANOVA model on the log10 transformation of theconcentrations. The ANOVA model included the vaccine group as fixed effect.||To demonstrate lot-to-lot consistency in terms of immunogenicity between the 3 industrial production lots (600L scale) of the Cervarix™ vaccine, one month post dose 3 (Month 7). If consistency was demonstrated the 3 lots would be pooled and non-inferiority of the 600L scale lot vaccine versus the 80L scale would be evaluated as a second primary objective.||1.49|0.95|
72347773|NCT00250276|144217134|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The first primary objective was reached as the 95% CIs of the GMC ratio between lots were within \[0.5;2\] for the anti-HPV-16 antibodies.|GMC ratio for anti-HPV-16 antibody|1.26|||||TWO_SIDED|95.0|0.98|1.63|||ANOVA|The ANOVA model on the log10 transformation of the concnetration. The ANOVA model included the vaccine group as fixed effect.||To demonstrate lot-to-lot consistency in terms of immunogenicity between the 3 industrial production lots (600L scale) of the Cervarix™ vaccine, one month post dose 3 (Month 7). If consistency was demonstrated the 3 lots would be pooled and non-inferiority of the 600L scale lot vaccine versus the 80L scale would be evaluated as a second primary objective.||1.63|0.98|
72347774|NCT00250276|144217134|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The first primary objective was reached as the 95% CIs of the GMC ratio between lots were within \[0.5;2\] for the anti-HPV-18 antibodies.|GMC ratio for anti-HPV-18 antibody|1.48|||||TWO_SIDED|95.0|1.18|1.85|||ANOVA|The ANOVA model on the log10 transformation of the concnetration. The ANOVA model included the vaccine group as fixed effect.||To demonstrate lot-to-lot consistency in terms of immunogenicity between the 3 industrial production lots (600L scale) of the Cervarix™ vaccine, one month post dose 3 (Month 7). If consistency was demonstrated the 3 lots would be pooled and non-inferiority of the 600L scale lot vaccine versus the 80L scale would be evaluated as a second primary objective.||1.85|1.18|
72429074|NCT04039503|144369071|SUPERIORITY||LS Mean Difference|-7.8|||<|0.001|TWO_SIDED|95.0|-9.4|-6.3|||Mixed Models Analysis|||||-6.3|-9.4|<0.001
72429075|NCT04039503|144369071|SUPERIORITY||LS Mean Difference|-9.9|||<|0.001|TWO_SIDED|95.0|-11.5|-8.3|||Mixed Models Analysis|||||-8.3|-11.5|<0.001
72429076|NCT04039503|144369071|SUPERIORITY||LS Mean Difference|-12.6|||<|0.001|TWO_SIDED|95.0|-14.2|-11.0|||Mixed Models Analysis|||||-11.0|-14.2|<0.001
72429077|NCT04039503|144369072|SUPERIORITY||Odds Ratio (OR)|37.77|||<|0.001|TWO_SIDED|95.0|15.23|93.7|||Regression, Logistic|||||93.70|15.23|<0.001
72429078|NCT04039503|144369072|SUPERIORITY||Odds Ratio (OR)|100.07|||<|0.001|TWO_SIDED|95.0|30.02|333.62|||Regression, Logistic|||||333.62|30.02|<0.001
72347775|NCT00250276|144217134|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The first primary objective was reached as the 95% CIs of the GMC ratio between lots were within \[0.5;2\] for the anti-HPV-16 antibodies.|GMT ratio for anti-HPV-16 antibody|1.21|||||TWO_SIDED|95.0|0.94|1.55|||ANOVA|The ANOVA model on the log10 transformation of the concentration. The ANOVA model included the vaccine group as fixed effect.||To demonstrate lot-to-lot consistency in terms of immunogenicity between the 3 industrial production lots (600L scale) of the Cervarix™ vaccine, one month post dose 3 (Month 7). If consistency was demonstrated the 3 lots would be pooled and non-inferiority of the 600L scale lot vaccine versus the 80L scale would be evaluated as a second primary objective.||1.55|0.94|
72347776|NCT00250276|144217134|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The first primary objective was reached as the 95% CIs of the GMC ratio between lots were within \[0.5;2\] for the anti-HPV-18 antibodies.|GMC ratio for anti-HPV-18 antibody|1.24|||||TWO_SIDED|95.0|1.0|1.55|||ANOVA|The ANOVA model on the log10 transformation of the concentration. The ANOVA model included the vaccine group as fixed effect.||To demonstrate lot-to-lot consistency in terms of immunogenicity between the 3 industrial production lots (600L scale) of the Cervarix™ vaccine, one month post dose 3 (Month 7). If consistency was demonstrated the 3 lots would be pooled and non-inferiority of the 600L scale lot vaccine versus the 80L scale would be evaluated as a second primary objective.||1.55|1.00|
72347777|NCT00250276|144217134|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The second primary objective was reached as the upper limit of the 95% CI of the difference in seroconversion rates for anti-HPV-16 antibodies was below 5%.|Difference in seroconversion rate|0.0|||||TWO_SIDED|95.0|-3.63|1.02|||Proc StatXact 5.0|||To demonstrate that the Cervarix™ vaccine produced at 600L manufacturing scale was non-inferior in terms of immunogenicity to the Cervarix™ vaccine produced at 80L scale, one month after the third dose (Month 7).||1.02|-3.63|
72347778|NCT00250276|144217134|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The second primary objective was reached as the upper limit of the 95% CI of the difference in seroconversion rates for anti-HPV-18 antibodies was below 5%.|Difference in seroconversion rate|0.0|||||TWO_SIDED|95.0|-3.18|0.94|||Proc StatXact 5.0|||To demonstrate that the Cervarix™ vaccine produced at 600L manufacturing scale was non-inferior in terms of immunogenicity to the Cervarix™ vaccine produced at 80L scale, on month after the third dose (Month 7).||0.94|-3.18|
72347779|NCT00250276|144217134|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The second primary objective was reached as the upper limit of the 95% CI of the GMC rates for anti-HPV-16 was below 2%.|GMC ratio for anti-HPV-16 antibody|0.87|||||TWO_SIDED|95.0|0.7|1.08|||ANOVA|The ANOVA model on the log10 transformation of the concentration, included the vaccine groups as fixed effect (pooled 600L lot versus 80L lot).||To demonstrate that the Cervarix™ vaccine produced at 600L manufacturing scale was non-inferior in terms of immunogenicity to the Cervarix™ vaccine produced at 80L scale, on month after the third dose (Month 7).||1.08|0.70|
72347780|NCT00250276|144217134|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The second primary objective was reached as the upper limit of the 95% CI of the GMC rates anti-HPV-18 antibodies was below 2%.|GMC ratio for anti-HPV-18 antibody|0.8|||||TWO_SIDED|95.0|0.66|0.97|||ANOVA|The ANOVA model on the log10 transformation of the concentration, included the vaccine groups as fixed effect (pooled 600L lot versus 80L lot).||To demonstrate that the Cervarix™ vaccine produced at 600L manufacturing scale was non-inferior in terms of immunogenicity to the Cervarix™ vaccine produced at 80L scale, on month after the third dose (Month 7).||0.97|0.66|
72347781|NCT03334812|144217171|SUPERIORITY||Mean Difference (Net)|0.18||||0.1219|TWO_SIDED|95.0|-0.15|0.51|||Mixed Effect Model Repeat Measurement|||SCD/HNWB||0.51|-0.15|0.1219
72347782|NCT03334812|144217171|SUPERIORITY||Mean Difference (Net)|-0.01||||0.5438|TWO_SIDED|95.0|-0.28|0.25|||Mixed Effect Model Repeat Measurement|||DTBT/HWB||0.25|-0.28|0.5438
72347783|NCT03334812|144217172|SUPERIORITY||Mean Difference (Final Values)|0.06||||0.3067|TWO_SIDED|95.0|-0.19|0.31|||Mixed Effect Model Repeat Measurement|||||0.31|-0.19|0.3067
72347784|NCT03334812|144217174|SUPERIORITY||Mean Difference (Net)|26.23||||0.0404|TWO_SIDED|95.0|-3.86|56.32|||Mixed Effect Model Repeat Measurement|||Week 4||56.32|-3.86|0.0404
72347785|NCT03334812|144217174|SUPERIORITY||Mean Difference (Net)|27.82||||0.1381|TWO_SIDED|95.0|-26.5|82.1|||Mixed Effect Model Repeat Measurement|||Week 12||82.10|-26.5|0.1381
72347786|NCT03334812|144217174|SUPERIORITY||Mean Difference (Net)|23.8||||0.1168|TWO_SIDED|96.0|-19.3|66.89|||Mixed Models Analysis|||Week 28 (EOS)||66.89|-19.3|0.1168
72347787|NCT03334812|144217175|SUPERIORITY||Mean Difference (Net)|-0.01||||0.5175|TWO_SIDED|95.0|-0.26|0.25|||Mixed Effect Model Repeat Measurement|||SCD/HNWB - Week 12||0.25|-0.26|0.5175
72347788|NCT03334812|144217175|SUPERIORITY||Mean Difference (Net)|0.19||||0.1476|TWO_SIDED|95.0|-0.22|0.6|||Mixed Effect Model Repeat Measurement|||SCD/HNWB - Week 28||0.60|-0.22|0.1476
72347789|NCT01153724|144217180|NON_INFERIORITY_OR_EQUIVALENCE|Relative bioavailability|Adjusted geometric mean ratio|113.29|STANDARD_DEVIATION|13.6||0.0101|TWO_SIDED|90.0|105.893|121.197||P-value for ratio outside interval 0.8-1.25|ANOVA|Adjusted geometric mean ratio|The standard deviation is actually the geometric coefficient of variation|Ratio Olodaterol plus Fluconazole and Olodaterol||121.197|105.893|0.0101
72347790|NCT01153724|144217181|NON_INFERIORITY_OR_EQUIVALENCE|Relative bioavailability|Adjusted geometric mean ratio|108.78|STANDARD_DEVIATION|15.5||0.0009|TWO_SIDED|90.0|101.59|116.487||P-value for ratio outside interval 0.8-1.25|ANOVA|Adjusted geometric mean ratio|The standard deviation is actually the geometric coefficient of variation|Ratio Olodaterol plus Fluconazole and Olodaterol for the category Olodaterol||116.487|101.590|0.0009
72347791|NCT01153724|144217181|NON_INFERIORITY_OR_EQUIVALENCE|Relative bioavailability|Adjusted geometric mean|85.98|STANDARD_DEVIATION|19.4||0.0711|TWO_SIDED|90.0|79.277|93.253||P-value for ratio outside interval 0.8-1.25|ANOVA|Adjusted geometric mean ratio|The standard deviation is actually the geometric coefficient of variation|Ratio Olodaterol plus Fluconazole and Olodaterol for the category Olodaterol glucuronide||93.253|79.277|0.0711
72347792|NCT01153724|144217184|NON_INFERIORITY_OR_EQUIVALENCE|Relative bioavailability|Adjusted geometric mean ratio|114.83|STANDARD_DEVIATION|33.5||0.1539|TWO_SIDED|90.0|99.94|131.932||P-value for ratio outside interval 0.8-1.25|ANOVA|Adjusted geometric mean ratio|The standard deviation is actually the geometric coefficient of variation|Ratio Olodaterol plus Fluconazole and Olodaterol for the category Olodaterol||131.932|99.940|0.1539
72347793|NCT01153724|144217184|NON_INFERIORITY_OR_EQUIVALENCE|Relative bioavailability|Adjusted geometric mean ratio|74.48|STANDARD_DEVIATION|1.068||0.8574|TWO_SIDED|90.0|66.619|83.266||P-value for ratio outside interval 0.8-1.25|ANOVA|Adjusted geometric mean ratio|The standard deviation is actually the geometric coefficient of variation|Ratio Olodaterol plus Fluconazole and Olodaterol for the category Olodaterol glucuronide||83.266|66.619|0.8574
72347794|NCT01153724|144217185|NON_INFERIORITY_OR_EQUIVALENCE|Relative bioavailability|Adjusted geometric mean ratio|74.08|STANDARD_DEVIATION|14.6||0.9646|TWO_SIDED|90.0|69.105|79.418||P-value for ratio outside interval 0.8-1.25|ANOVA|Adjusted geometric mean ratio|The standard deviation is actually the geometric coefficient of variation|Ratio Olodaterol plus Fluconazole and Olodaterol||79.418|69.105|0.9646
72347795|NCT00524472|144217238|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.62||||0.0043|TWO_SIDED|95.0|0.39|0.97||"P-values for combined sites: significant if P \< 0.0085 for efficacy. Adjusted for interim analysis.~Confidence intervals adjusted for interim analysis."|Cochran-Mantel-Haenszel||Hyperinsulinemic-normoglycemic clamp|||0.97|0.39|0.0043
72347796|NCT00524472|144217239|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.92||||0.29|TWO_SIDED|95.0|0.75|1.13|||Cochran-Mantel-Haenszel||HN vs. standard|||1.13|0.75|0.29
72347797|NCT00524472|144217240|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.05||||0.99|TWO_SIDED|95.0|0.91|1.21|||Regression, Cox|||||1.21|0.91|0.99
72347798|NCT00524472|144217241|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.13||||0.025|TWO_SIDED|95.0|0.98|1.31|||Regression, Cox||HN vs. Standard|||1.31|0.98|0.025
72347799|NCT00524472|144217242|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.52||||0.12|TWO_SIDED|95.0|0.74|3.11|||Cochran-Mantel-Haenszel||HN vs. standard|||3.11|0.74|0.12
72347800|NCT00524472|144217243|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.88||||0.085|TWO_SIDED|95.0|0.72|1.07|||Cochran-Mantel-Haenszel||HN vs. Standard|||1.07|0.72|0.085
72347801|NCT02508428|144217244|EQUIVALENCE|Differences in survivorship among the Marathon and Enduron liners were evaluated with a Log Rank test.|||||<|0.001||||||A p-value of 0.05 was used as the threshold for statistical significance.|Log Rank|||Survivorship was evaluated using liner revision for wear/osteolysis as an endpoint using a Kaplan-Meier analysis.||||<0.001
72347802|NCT02508428|144217245|EQUIVALENCE|"Since the null hypothesis assumed that the wear rates were not different, Equivalence has been specified for the Type of Statistical Test"|Mean Difference (Net)|0.22|||<|0.001|TWO_SIDED|95.0|0.17|0.27||A p-value of 0.05 was used as the threshold for statistical significance.|t-test, 2 sided|||||0.27|0.17|<0.001
72347803|NCT02508428|144217246|EQUIVALENCE|"Since the null hypothesis assumed that the incidences of clinically important osteolysis were not different, Equivalence has been specified for the Type of Statistical Test"|Risk Ratio (RR)|0.04|||<|0.001|TWO_SIDED|95.0|0.006|0.3||A p-value of 0.05 was used as the threshold for statistical significance.|Fisher Exact|||||0.30|0.006|<0.001
72347804|NCT02508428|144217247|EQUIVALENCE|"Since the null hypothesis assumed that the rate of satisfaction among the groups were not different, Equivalence has been specified for the Type of Statistical Test"||||||0.48||||||A p-value of 0.05 was used as the threshold for statistical significance.|Fisher Exact|||Since there were no patients with Marathon liners who were unsatisfied with the outcome of their hip replacement, a relative risk and the associated confidence interval could not be calculated.||||0.48
72347805|NCT02508428|144217248|EQUIVALENCE|"Since the null hypothesis assumed that the Harris Hip Scores among the groups were not different, Equivalence has been specified for the Type of Statistical Test"||||||0.4||||||A p-value of 0.05 was used as the threshold for statistical significance.|Wilcoxon (Mann-Whitney)|||||||.40
72347806|NCT02748070|144217249|OTHER|||||||0.819|||||||t-test, 2 sided|||Comparison of baseline and 1 week||||0.819
72347807|NCT02748070|144217249|OTHER|||||||0.665|||||||t-test, 2 sided|||Comparison of baseline and 1 month||||0.665
72347808|NCT02748070|144217249|OTHER|||||||0.071|||||||t-test, 2 sided|||Comparison of baseline and 3 months||||0.071
72347809|NCT02748070|144217249|OTHER|||||||0.097|||||||t-test, 2 sided|||Comparison of baseline and 6 months||||0.097
72429079|NCT04039503|144369072|SUPERIORITY||Odds Ratio (OR)|43.31|||<|0.001|TWO_SIDED|95.0|16.92|110.83|||Regression, Logistic|||||110.83|16.92|<0.001
72347810|NCT02748070|144217250|OTHER|||||||0.376|||||||t-test, 2 sided|||Comparison of baseline and 1 week||||0.376
72347811|NCT02748070|144217250|OTHER|||||||0.685|||||||t-test, 2 sided|||Comparison of baseline and 1 month||||0.685
72347812|NCT02748070|144217250|OTHER|||||||0.388|||||||t-test, 2 sided|||Comparison of baseline and 3 months||||0.388
72347813|NCT02748070|144217250|OTHER|||||||0.233|||||||t-test, 2 sided|||Comparison of baseline and 6 months||||0.233
72347814|NCT00928694|144217251|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence bounds = (0.80, 1.25) Study Primary Hypothesis: Single 160 mg doses of the U.S. and UK formulations of fenofibrate following consumption of a standard breakfast are bioequivalent (the true geometric mean ratios (GMRs) \[U.S./UK\] for the AUC(0 to infinity) and maximum plasma concentration (Cmax) of fenofibric acid after administration of the U.S. and UK formulations of fenofibrate with food are contained in the interval \[0.80, 1.25\]).|Geometric Mean Ratio|0.96||||||90.0|0.9|1.02||||||||1.02|0.90|
72347815|NCT00928694|144217252|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence bounds = (0.80, 1.25) Study Primary Hypothesis: Single 160 mg doses of the U.S. and UK formulations of fenofibrate following consumption of a standard breakfast are bioequivalent (the true GMRs \[U.S./UK\] for the AUC(0 to infinity) and Cmax of fenofibric acid after administration of the U.S. and UK formulations of fenofibrate with food are contained in the interval \[0.80, 1.25\]).|Geometric Mean Ratio|0.98||||||90.0|0.9|1.06||||||||1.06|0.90|
72347816|NCT00534976|144217253|SUPERIORITY_OR_OTHER_LEGACY||Difference in least square means|-4.65||||0.02||95.0|||||ANOVA||Montelukast minus placebo|||||0.020
72347817|NCT00534976|144217254|SUPERIORITY_OR_OTHER_LEGACY||Difference in least square means|-4.33||||0.005||95.0|||||ANOVA||Montelukast minus placebo|||||0.005
72347818|NCT00534976|144217255|SUPERIORITY_OR_OTHER_LEGACY||Difference in least square means|-120.86||||0.022||95.0|||||ANOVA||Montelukast minus placebo|||||0.022
72347819|NCT00534976|144217256|SUPERIORITY_OR_OTHER_LEGACY||Difference in least square means|-122.82||||0.013||95.0|||||ANOVA||Montelukast minus placebo|||||0.013
72347820|NCT00534976|144217257|SUPERIORITY_OR_OTHER_LEGACY||Difference in least square means|-8.27||||0.064||95.0|||||ANOVA||Montelukast minus placebo|||||0.064
72347821|NCT00534976|144217258|SUPERIORITY_OR_OTHER_LEGACY||Difference in least square means|-7.06||||0.054||95.0|||||ANOVA||Montelukast minus Placebo|||||0.054
72347822|NCT00534976|144217259|SUPERIORITY_OR_OTHER_LEGACY||Difference in Proportions|-1.6||||1||95.0||||P-value provided is for comparison between the two proportions: Montelukast versus placebo.|McNemar||Montelukast minus placebo|||||1.000
72347823|NCT00534976|144217260|SUPERIORITY_OR_OTHER_LEGACY||Difference in Proportions|-3.2||||||95.0|||||||Montelukast minus placebo|||||
72429080|NCT04039503|144369073|SUPERIORITY||LS Mean Difference|-22.5|||<|0.001|TWO_SIDED|95.0|-29.5|-15.4|||Mixed Models Analysis|||||-15.4|-29.5|<0.001
72347824|NCT01865448|144217288|SUPERIORITY_OR_OTHER|||||||0.278|TWO_SIDED||||||ANCOVA|||Between-Group Comparison||||0.2780
72347825|NCT01865448|144217288|SUPERIORITY_OR_OTHER|||||||0.8689|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data||||0.8689
72347826|NCT01865448|144217288|SUPERIORITY_OR_OTHER|||||||0.4533|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data||||0.4533
72347827|NCT01865448|144217289|SUPERIORITY_OR_OTHER|||||||0.71833|TWO_SIDED||||||ANCOVA|||Between-Group Comparison||||0.71833
72347828|NCT01865448|144217289|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data||||<0.001
72347829|NCT01865448|144217289|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Within-group comparisons between the baseline and 6 month data||||<0.001
72347830|NCT01865448|144217290|SUPERIORITY_OR_OTHER|||||||0.519|TWO_SIDED||||||ANCOVA|||Between-Group Comparison||||0.51900
72347831|NCT01865448|144217290|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data||||<0.001
72347832|NCT01865448|144217290|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data||||<0.001
72347833|NCT01865448|144217291|SUPERIORITY_OR_OTHER|||||||0.24567|TWO_SIDED||||||ANCOVA|||Between-Group Comparison||||0.24567
72347834|NCT01865448|144217291|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data||||<0.001
72347835|NCT01865448|144217291|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data||||<0.001
72347836|NCT01865448|144217292|SUPERIORITY_OR_OTHER|||||||0.9573|TWO_SIDED||||||ANCOVA|||Between-Group Comparison||||0.9573
72347837|NCT01865448|144217292|SUPERIORITY_OR_OTHER|||||||0.5257|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data||||0.5257
72347838|NCT01865448|144217292|SUPERIORITY_OR_OTHER|||||||0.0657|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data||||0.0657
72347839|NCT01865448|144217293|SUPERIORITY_OR_OTHER|||||||0.7474|TWO_SIDED||||||ANCOVA|||Between-Group Comparison||||0.7474
72347840|NCT01865448|144217293|SUPERIORITY_OR_OTHER|||||||0.3745|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data||||0.3745
72347841|NCT01865448|144217293|SUPERIORITY_OR_OTHER|||||||0.0476|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data||||0.0476
72347842|NCT01865448|144217294|SUPERIORITY_OR_OTHER|||||||0.27444|TWO_SIDED||||||ANCOVA|||Between-Group Comparison||||0.27444
72347843|NCT01865448|144217294|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data||||<0.001
72347844|NCT01865448|144217294|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data||||<0.001
72347845|NCT01865448|144217295|SUPERIORITY_OR_OTHER|||||||0.28489|TWO_SIDED||||||ANCOVA|||Between-Group Comparison||||0.28489
72347846|NCT01865448|144217295|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data||||<0.001
72347847|NCT01865448|144217295|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Paired t-test|||||||<0.001
72347848|NCT01865448|144217296|SUPERIORITY_OR_OTHER|||||||0.04491|TWO_SIDED||||||ANCOVA|||Between-Group Comparison||||0.04491
72347849|NCT01865448|144217296|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data||||<0.001
72347850|NCT01865448|144217296|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data||||<0.001
72347851|NCT01865448|144217297|SUPERIORITY_OR_OTHER|||||||0.24396|TWO_SIDED||||||ANCOVA|||Between-Group Comparison||||0.24396
72347852|NCT01865448|144217297|SUPERIORITY_OR_OTHER|||||||0.00162|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data||||0.00162
72347853|NCT01865448|144217297|SUPERIORITY_OR_OTHER|||||||0.00162|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data||||0.00162
72347854|NCT01865448|144217298|SUPERIORITY_OR_OTHER|||||||0.82322|TWO_SIDED||||||ANCOVA|||Between-Group Comparison||||0.82322
72347855|NCT01865448|144217298|SUPERIORITY_OR_OTHER|||||||0.25908|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data||||0.25908
72347856|NCT01865448|144217298|SUPERIORITY_OR_OTHER|||||||0.25908|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data||||0.25908
72347857|NCT01865448|144217299|SUPERIORITY_OR_OTHER|||||||0.76435|TWO_SIDED||||||ANCOVA|||Between-Group Comparison||||0.76435
72347858|NCT01865448|144217299|SUPERIORITY_OR_OTHER|||||||0.18876|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data||||0.18876
72347859|NCT01865448|144217299|SUPERIORITY_OR_OTHER|||||||0.18876|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data||||0.18876
72347860|NCT01865448|144217300|SUPERIORITY_OR_OTHER|||||||0.40485|TWO_SIDED||||||ANCOVA|||Between-Group Comparison||||0.40485
72347861|NCT01865448|144217300|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data||||<0.001
72347862|NCT01865448|144217300|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data||||<0.001
72347863|NCT01865448|144217301|SUPERIORITY_OR_OTHER|||||||0.13911|TWO_SIDED||||||ANCOVA|||Between-Group Comparison||||0.13911
72347864|NCT01865448|144217301|SUPERIORITY_OR_OTHER|||||||0.05726|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data||||0.05726
72347865|NCT01865448|144217301|SUPERIORITY_OR_OTHER|||||||0.05726|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data||||0.05726
72347866|NCT01865448|144217302|SUPERIORITY_OR_OTHER|||||||0.60214|TWO_SIDED||||||ANCOVA|||Between-Group Comparison||||0.60214
72347867|NCT01865448|144217302|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data||||<0.001
72347868|NCT01865448|144217302|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data||||<0.001
72347869|NCT01865448|144217303|SUPERIORITY_OR_OTHER|||||||0.66053|TWO_SIDED||||||ANCOVA|||Between-Group Comparison||||0.66053
72347870|NCT01865448|144217303|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data||||<0.001
72347871|NCT01865448|144217303|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data||||<0.05
72347872|NCT01865448|144217304|SUPERIORITY_OR_OTHER|||||||0.28743|TWO_SIDED||||||ANCOVA|||Between-Group Comparison||||0.28743
72347873|NCT01865448|144217304|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data||||<0.001
72347874|NCT01865448|144217304|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data||||<0.001
72347875|NCT01865448|144217305|SUPERIORITY_OR_OTHER|||||||0.58561|TWO_SIDED||||||ANCOVA|||Between-Group Comparison||||0.58561
72347876|NCT01865448|144217305|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data||||<0.001
72347877|NCT01865448|144217305|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Paired t-test|||||||<0.001
72347878|NCT01865448|144217306|SUPERIORITY_OR_OTHER|||||||0.1953|TWO_SIDED||||||ANCOVA|||Between-Group Comparison||||0.1953
72347879|NCT01865448|144217306|SUPERIORITY_OR_OTHER|||||||0.0351|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data||||0.0351
72347880|NCT01865448|144217306|SUPERIORITY_OR_OTHER|||||||0.0795|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data||||0.0795
72347881|NCT01865448|144217307|SUPERIORITY_OR_OTHER|||||||0.6664|TWO_SIDED||||||ANCOVA|||Between-Group Comparison||||0.6664
72347882|NCT01865448|144217307|SUPERIORITY_OR_OTHER|||||||0.431|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data||||0.4310
72347883|NCT01865448|144217307|SUPERIORITY_OR_OTHER|||||||0.0049|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data||||0.0049
72347884|NCT01865448|144217308|SUPERIORITY_OR_OTHER|||||||0.247|TWO_SIDED||||||ANCOVA|||Between-Group Comparison||||0.2470
72347885|NCT01865448|144217308|SUPERIORITY_OR_OTHER|||||||0.2755|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data||||0.2755
72347886|NCT01865448|144217308|SUPERIORITY_OR_OTHER|||||||0.8226|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data||||0.8226
72429081|NCT04039503|144369073|SUPERIORITY||LS Mean Difference|-29.0|||<|0.001|TWO_SIDED|95.0|-36.0|-22.0|||Mixed Models Analysis|||||-22.0|-36.0|<0.001
72429082|NCT04039503|144369073|SUPERIORITY||LS Mean Difference|-28.8|||<|0.001|TWO_SIDED|95.0|-35.9|-21.6|||Mixed Models Analysis|||||-21.6|-35.9|<0.001
72347887|NCT01865448|144217309|SUPERIORITY_OR_OTHER|||||||0.6779|||||||ANCOVA|||Between-Group Comparison||||0.6779
72347888|NCT01865448|144217309|SUPERIORITY_OR_OTHER|||||||0.3761|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data||||0.3761
72347889|NCT01865448|144217309|SUPERIORITY_OR_OTHER|||||||0.0281|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data||||0.0281
72347890|NCT01865448|144217310|SUPERIORITY_OR_OTHER|||||||0.8591|TWO_SIDED||||||ANCOVA|||Between-Group Comparison||||0.8591
72347891|NCT01865448|144217310|SUPERIORITY_OR_OTHER|||||||0.0404|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data||||0.0404
72347892|NCT01865448|144217310|SUPERIORITY_OR_OTHER|||||||0.0474|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data||||0.0474
72347893|NCT01865448|144217311|SUPERIORITY_OR_OTHER|||||||0.3187|TWO_SIDED||||||ANCOVA|||Between-Group Comparison||||0.3187
72347894|NCT01865448|144217311|SUPERIORITY_OR_OTHER|||||||0.0482|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data||||0.0482
72347895|NCT01865448|144217311|SUPERIORITY_OR_OTHER|||||||0.0394|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data||||0.0394
72347896|NCT01865448|144217312|SUPERIORITY_OR_OTHER|||||||0.2813|TWO_SIDED||||||ANCOVA|||Between-Group Comparison||||0.2813
72347897|NCT01865448|144217312|SUPERIORITY_OR_OTHER|||||||0.4421|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data||||0.4421
72347898|NCT01865448|144217312|SUPERIORITY_OR_OTHER|||||||0.3198|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data||||0.3198
72347899|NCT01865448|144217313|SUPERIORITY_OR_OTHER|||||||0.2792|TWO_SIDED||||||ANCOVA|||Between-Group Comparison||||0.2792
72347900|NCT01865448|144217313|SUPERIORITY_OR_OTHER|||||||0.1034|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data||||0.1034
72347901|NCT01865448|144217313|SUPERIORITY_OR_OTHER|||||||0.9898|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data||||0.9898
72347902|NCT01865448|144217314|SUPERIORITY_OR_OTHER|||||||0.7047|TWO_SIDED||||||ANCOVA|||Between-Group Comparison||||0.7047
72347903|NCT01865448|144217314|SUPERIORITY_OR_OTHER|||||||0.4749|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data||||0.4749
72347904|NCT01865448|144217314|SUPERIORITY_OR_OTHER|||||||0.6014|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data||||0.6014
72347905|NCT01865448|144217315|SUPERIORITY_OR_OTHER|||||||0.5932|TWO_SIDED||||||ANCOVA|||Between-Group Comparison||||0.5932
72347906|NCT01865448|144217315|SUPERIORITY_OR_OTHER|||||||0.714|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data||||0.7140
72347907|NCT01865448|144217315|SUPERIORITY_OR_OTHER|||||||0.5827|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data||||0.5827
72347908|NCT01865448|144217316|SUPERIORITY_OR_OTHER|||||||0.2894|TWO_SIDED||||||ANCOVA|||Between-Group Comparison||||0.2894
72347909|NCT01865448|144217316|SUPERIORITY_OR_OTHER|||||||0.2128|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data||||0.2128
72347910|NCT01865448|144217316|SUPERIORITY_OR_OTHER|||||||0.0823|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data||||0.0823
72347911|NCT01865448|144217317|SUPERIORITY_OR_OTHER|||||||0.345|||||||ANCOVA|||Between-Group Comparison||||0.3450
72347912|NCT01865448|144217317|SUPERIORITY_OR_OTHER|||||||0.1365|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data||||0.1365
72347913|NCT01865448|144217317|SUPERIORITY_OR_OTHER|||||||0.0073|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data||||0.0073
72429083|NCT04039503|144369075|SUPERIORITY||Odds Ratio (OR)|17.15|||<|0.001|TWO_SIDED|95.0|7.55|38.93|||Regression, Logistic|||||38.93|7.55|<0.001
72429084|NCT04039503|144369075|SUPERIORITY||Odds Ratio (OR)|27.24|||<|0.001|TWO_SIDED|95.0|11.87|62.55|||Regression, Logistic|||||62.55|11.87|<0.001
72347914|NCT01865448|144217318|SUPERIORITY_OR_OTHER|||||||0.2333|TWO_SIDED||||||ANCOVA|||Between-Group Comparison||||0.2333
72347915|NCT01865448|144217318|SUPERIORITY_OR_OTHER|||||||0.4292|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data||||0.4292
72347916|NCT01865448|144217318|SUPERIORITY_OR_OTHER|||||||0.3356|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data||||0.3356
72347917|NCT01865448|144217319|SUPERIORITY_OR_OTHER|||||||0.683|TWO_SIDED||||||ANCOVA|||Between-Group Comparison||||0.6830
72347918|NCT01865448|144217319|SUPERIORITY_OR_OTHER|||||||0.8625|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data||||0.8625
72347919|NCT01865448|144217319|SUPERIORITY_OR_OTHER|||||||0.0068|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data||||0.0068
72347920|NCT01865448|144217320|SUPERIORITY_OR_OTHER|||||||0.3694|TWO_SIDED||||||ANCOVA|||Between-Group Comparison||||0.3694
72347921|NCT01865448|144217320|SUPERIORITY_OR_OTHER|||||||0.0291|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data||||0.0291
72347922|NCT01865448|144217320|SUPERIORITY_OR_OTHER|||||||0.0402|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data||||0.0402
72347923|NCT01865448|144217321|SUPERIORITY_OR_OTHER|||||||0.1226|TWO_SIDED||||||ANCOVA|||Between-Group Comparison||||0.1226
72347924|NCT01865448|144217321|SUPERIORITY_OR_OTHER|||||||0.0472|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data||||0.0472
72347925|NCT01865448|144217321|SUPERIORITY_OR_OTHER|||||||0.0197|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data||||0.0197
72347926|NCT01865448|144217322|SUPERIORITY_OR_OTHER|||||||0.8969|TWO_SIDED||||||ANCOVA|||Between-Group Comparison||||0.8969
72347927|NCT01865448|144217322|SUPERIORITY_OR_OTHER|||||||0.7218|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data||||0.7218
72347928|NCT01865448|144217322|SUPERIORITY_OR_OTHER|||||||0.4536|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data||||0.4536
72347929|NCT01865448|144217323|SUPERIORITY_OR_OTHER|||||||0.8765|TWO_SIDED||||||ANCOVA|||Between-Group Comparison||||0.8765
72347930|NCT01865448|144217323|SUPERIORITY_OR_OTHER|||||||0.5114|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data||||0.5114
72347931|NCT01865448|144217323|SUPERIORITY_OR_OTHER|||||||0.0237|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data||||0.0237
72347932|NCT01865448|144217324|SUPERIORITY_OR_OTHER|||||||0.2914|TWO_SIDED||||||ANCOVA|||Between-Group Comparison||||0.2914
72347933|NCT01865448|144217324|SUPERIORITY_OR_OTHER|||||||0.5594|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data||||0.5594
72347934|NCT01865448|144217324|SUPERIORITY_OR_OTHER|||||||0.2532|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data||||0.2532
72347935|NCT01865448|144217325|SUPERIORITY_OR_OTHER|||||||0.0528|TWO_SIDED||||||ANCOVA|||Between-Group Comparison||||0.0528
72347936|NCT01865448|144217325|SUPERIORITY_OR_OTHER|||||||0.192|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data||||0.1920
72347937|NCT01865448|144217325|SUPERIORITY_OR_OTHER|||||||0.0011|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data||||0.0011
72347938|NCT01865448|144217326|SUPERIORITY_OR_OTHER|||||||0.2999|TWO_SIDED||||||ANCOVA|||Between-Group Comparison||||0.2999
72347939|NCT01865448|144217326|SUPERIORITY_OR_OTHER|||||||0.5184|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data||||0.5184
72347940|NCT01865448|144217326|SUPERIORITY_OR_OTHER|||||||0.0564|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data||||0.0564
72347941|NCT01865448|144217327|SUPERIORITY_OR_OTHER|||||||0.0783|TWO_SIDED||||||ANCOVA|||Between-Group Comparison||||0.0783
72347942|NCT01865448|144217327|SUPERIORITY_OR_OTHER|||||||0.1263|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data||||0.1263
72347943|NCT01865448|144217327|SUPERIORITY_OR_OTHER|||||||0.6484|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data||||0.6484
72347944|NCT01865448|144217328|SUPERIORITY_OR_OTHER|||||||0.6896|TWO_SIDED||||||ANCOVA|||Between-Group Comparison||||0.6896
72347945|NCT01865448|144217328|SUPERIORITY_OR_OTHER|||||||0.098|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data||||0.0980
72347946|NCT01865448|144217328|SUPERIORITY_OR_OTHER|||||||0.3526|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data||||0.3526
72347947|NCT01865448|144217329|SUPERIORITY_OR_OTHER|||||||0.9662|TWO_SIDED||||||ANCOVA|||Between-Group Comparison||||0.9662
72347948|NCT01865448|144217329|SUPERIORITY_OR_OTHER|||||||0.145|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data||||0.1450
72347949|NCT01865448|144217329|SUPERIORITY_OR_OTHER|||||||0.3811|TWO_SIDED||||||Paired t-test|||||||0.3811
72347950|NCT01865448|144217330|SUPERIORITY_OR_OTHER|||||||0.2643|TWO_SIDED||||||ANCOVA|||Between-Group Comparison||||0.2643
72347951|NCT01865448|144217330|SUPERIORITY_OR_OTHER|||||||0.0761|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data||||0.0761
72347952|NCT01865448|144217330|SUPERIORITY_OR_OTHER|||||||0.1342|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data||||0.1342
72347953|NCT01865448|144217331|SUPERIORITY_OR_OTHER|||||||0.141|TWO_SIDED||||||ANCOVA|||Between-Group Comparison||||0.1410
72347954|NCT01865448|144217331|SUPERIORITY_OR_OTHER|||||||0.3774|||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data||||0.3774
72347955|NCT01865448|144217331|SUPERIORITY_OR_OTHER|||||||0.1811|TWO_SIDED||||||Paired t-test|||||||0.1811
72347956|NCT01865448|144217332|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|||Between-Group Comparison||||<0.0001
72347957|NCT01865448|144217332|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data||||<0.0001
72347958|NCT01865448|144217332|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data||||<0.0001
72347959|NCT01865448|144217333|SUPERIORITY_OR_OTHER|||||||0.5893|TWO_SIDED||||||ANCOVA|||Between-Group Comparison||||0.5893
72347960|NCT01865448|144217333|SUPERIORITY_OR_OTHER|||||||0.0431|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data||||0.0431
72347961|NCT01865448|144217333|SUPERIORITY_OR_OTHER|||||||0.0066|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data||||0.0066
72347962|NCT01865448|144217334|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|||Between-Group Comparison||||<0.0001
72347963|NCT01865448|144217334|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data||||<0.0001
72347964|NCT01865448|144217334|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data||||<0.0001
72347965|NCT01865448|144217335|SUPERIORITY_OR_OTHER|||||||0.985|TWO_SIDED||||||ANCOVA|||Between-Group Comparison||||0.9850
72347966|NCT01865448|144217335|SUPERIORITY_OR_OTHER|||||||0.0049|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data||||0.0049
72347967|NCT01865448|144217335|SUPERIORITY_OR_OTHER|||||||0.0062|TWO_SIDED||||||Paired t-test|||||||0.0062
72347968|NCT01865448|144217336|SUPERIORITY_OR_OTHER|||||||0.1946|TWO_SIDED||||||ANCOVA|||Between-Group Comparison||||0.1946
72347969|NCT01865448|144217336|SUPERIORITY_OR_OTHER|||||||0.2337|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data||||0.2337
72347970|NCT01865448|144217336|SUPERIORITY_OR_OTHER|||||||0.9188|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data||||0.9188
72347971|NCT01865448|144217337|SUPERIORITY_OR_OTHER|||||||0.7964|TWO_SIDED||||||ANCOVA|||Between-Group Comparison||||0.7964
72429085|NCT04039503|144369075|SUPERIORITY||Odds Ratio (OR)|79.61|||<|0.001|TWO_SIDED|95.0|32.76|193.44|||Regression, Logistic|||||193.44|32.76|<0.001
72347972|NCT01865448|144217337|SUPERIORITY_OR_OTHER|||||||0.768|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data||||0.7680
72347973|NCT01865448|144217337|SUPERIORITY_OR_OTHER|||||||0.5669|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data||||0.5669
72347974|NCT01865448|144217338|SUPERIORITY_OR_OTHER|||||||0.032|TWO_SIDED||||||ANCOVA|||Between-Group Comparison||||0.0320
72347975|NCT01865448|144217338|SUPERIORITY_OR_OTHER|||||||0.022|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data||||0.0220
72347976|NCT01865448|144217338|SUPERIORITY_OR_OTHER|||||||0.4563|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data||||0.4563
72347977|NCT01865448|144217339|SUPERIORITY_OR_OTHER|||||||0.72828|TWO_SIDED||||||Fisher Exact|||Between-Group Comparison||||0.72828
72347978|NCT03004911|144217369|SUPERIORITY|||||||0.74|||||||t-test, 2 sided|||||||0.740
72347979|NCT03004911|144217370|SUPERIORITY|||||||0.89|||||||t-test, 2 sided|||||||0.890
72347980|NCT03004911|144217371|SUPERIORITY|||||||0.747|||||||t-test, 2 sided|||||||0.747
72347981|NCT03004911|144217372|SUPERIORITY|||||||1|||||||t-test, 2 sided|||||||1.000
72347982|NCT03004911|144217373|SUPERIORITY|||||||0.459|||||||t-test, 2 sided|||||||0.459
72347983|NCT02610777|144217375|SUPERIORITY||Hazard Ratio (HR)|0.861||||0.464|TWO_SIDED|95.0|0.577|1.286||P-value is from an unstratified log-rank test.|Log Rank||Hazard Ratio (HR) was based on an unstratified Cox proportional hazard regression model with treatment as a factor.|||1.286|0.577|0.464
72347984|NCT02610777|144217376|SUPERIORITY||Hazard Ratio (HR)|0.706|||=|0.092|TWO_SIDED|95.0|0.469|1.061||P-value comparing EFS between treatment groups was based on the unstratified log-rank test.|Log Rank||HR:unadjusted stratified Cox proportional hazard regression with stratification(low-blast AML,IPSS-R risk groups=very high,high,or intermediate for HRMDS/CMML),treatment as factor.HR\<1:better prevention of EFS in combination arm than azacitidine arm.|Event-Free Survival (EFS)||1.061|0.469|=0.092
72347985|NCT02610777|144217379|SUPERIORITY||Hazard Ratio (HR)|0.562|||=|0.267|TWO_SIDED|95.0|0.2|1.579||P-value is from an unstratified log-rank test.|Log Rank||Hazard ratio (HR) is based on an unstratified Cox proportional hazard regression model with treatment as a factor.|||1.579|0.200|=0.267
72347986|NCT02610777|144217380|SUPERIORITY||Absolute Rate Difference|9.61|||=|0.312|TWO_SIDED|95.0|-8.83|28.04||P-value is from an unstratified Cochran-Mantel Haenszel chi-square test.|Cochran-Mantel-Haenszel||Absolute difference \>0 represent better response achieved on pevonedistat combination compared to azacitidine treatment alone.|||28.04|-8.83|=0.312
72347987|NCT02610777|144217381|SUPERIORITY||Absolute Rate Difference|5.63||||0.56|TWO_SIDED|95.0|-13.19|24.44||P-value is from an unstratified Cochran-Mantel Haenszel chi-square test.|Cochran-Mantel-Haenszel||Absolute difference \>0 represent better response achieved on pevonedistat combination compared to azacitidine treatment alone.|||24.44|-13.19|0.560
72347988|NCT02610777|144217382|SUPERIORITY||Absolute Rate Difference|8.64|||=|0.343|TWO_SIDED|95.0|-9.09|26.38||P-value is from an unstratified Cochran-Mantel Haenszel chi-square test.|Cochran-Mantel-Haenszel||Absolute difference \>0 represent better response achieved on pevonedistat combination compared to azacitidine treatment alone.|||26.38|-9.09|=0.343
72347989|NCT02610777|144217383|SUPERIORITY||Absolute Rate Difference|-18.82|||=|0.296|TWO_SIDED|95.0|-52.91|15.26||P-value is from an unstratified Cochran-Mantel-Haenszel chi-square test.|Cochran-Mantel-Haenszel||Absolute difference \>0 represent better response achieved on pevonedistat combination compared to azacitidine treatment alone.|||15.26|-52.91|=0.296
72347990|NCT02610777|144217384|SUPERIORITY||Absolute Rate Difference|13.16|||=|0.152|TWO_SIDED|95.0|-4.49|30.81||P-value is from an unstratified Cochran-Mantel Haenszel chi-square test.|Cochran-Mantel-Haenszel||Absolute difference \>0 represent better response achieved on pevonedistat combination compared to azacitidine treatment alone.|||30.81|-4.49|=0.152
72347991|NCT02610777|144217385|SUPERIORITY||Absolute Rate Difference|10.53|||=|0.301|TWO_SIDED|95.0|-9.13|30.18||P-value is from an unstratified Cochran-Mantel Haenszel chi-square test.|Cochran-Mantel-Haenszel||Absolute difference \>0 represent better response achieved on pevonedistat combination compared to azacitidine treatment alone.|||30.18|-9.13|=0.301
72347992|NCT02610777|144217386|SUPERIORITY||Absolute Rate Difference|13.16|||=|0.254|TWO_SIDED|95.0|-9.12|35.44||P-value is from an unstratified Cochran-Mantel Haenszel chi-square test.|Cochran-Mantel-Haenszel||Absolute difference \>0 represent better response achieved on pevonedistat combination compared to azacitidine treatment alone.|||35.44|-9.12|=0.254
72347993|NCT02610777|144217387|SUPERIORITY||Absolute Rate Difference|-4.71|||=|0.787|TWO_SIDED|95.0|-38.33|28.92||P-value is from an unstratified Cochran-Mantel Haenszel chi-square test.|Cochran-Mantel-Haenszel||Absolute difference \>0 represent better response achieved on pevonedistat combination compared to azacitidine treatment alone.|||28.92|-38.33|=0.787
72429086|NCT04039503|144369076|SUPERIORITY||Estimate Difference|-35.4|||||TWO_SIDED|95.0|-46.0|-22.8||||||||-22.8|-46.0|
72347994|NCT02610777|144217388|SUPERIORITY||Hazard Ratio (HR)|0.789|||=|0.62|TWO_SIDED|95.0|0.308|2.02||P-value is from an unstratified log-rank test.|Log Rank||Hazard ratio was based on an unstratified Cox proportional hazard regression model and treatment as a factor in the model.|||2.020|0.308|=0.620
72347995|NCT02610777|144217389|SUPERIORITY||Hazard Ratio (HR)|0.719|||=|0.436|TWO_SIDED|95.0|0.313|1.653||P-value is from an unstratified log-rank test.|Log Rank||Hazard ratio was based on an unstratified Cox proportional hazard regression model and treatment as a factor in the model.|||1.653|0.313|=0.436
72347996|NCT02610777|144217390|SUPERIORITY||Hazard Ratio (HR)|0.81|||=|0.565|TWO_SIDED|95.0|0.395|1.662||P-value is from an unstratified log-rank test.|Log Rank||Hazard ratio was based on an unstratified Cox proportional hazard regression model and treatment as a factor in the model.|||1.662|0.395|=0.565
72347997|NCT02610777|144217391|SUPERIORITY||Hazard Ratio (HR)|0.42|||=|0.383|TWO_SIDED|95.0|0.057|3.109||P-value comparing duration of CR in low blast AML between treatment groups is based on unstratified log-rank test.|Log Rank||Hazard ratio was based on an unstratified Cox proportional hazard regression model and treatment as a factor in the model.|||3.109|0.057|=0.383
72347998|NCT02610777|144217392|SUPERIORITY||Hazard Ratio (HR)|1.206|||=|0.498|TWO_SIDED|95.0|0.699|2.081||P-value is from an unstratified log-rank test.|Log Rank||HR is based on an unstratified Cox proportional hazard regression model with treatment as a factor. HR\>1 for the treatment indicates a shorter time to first CR, CRi or PR in the Pevonedistat Combination arm compared to the Azacitidine only arm.|||2.081|0.699|=0.498
72347999|NCT02610777|144217393|SUPERIORITY||Hazard Ratio (HR)|0.905|||=|0.888|TWO_SIDED|95.0|0.226|3.62||P-value is from an unstratified log-rank test.|Log Rank||HR is based on an unstratified Cox proportional hazard regression model with treatment as a factor. HR\<1for the treatment indicates a longer time to Subsequent Therapy in the Pevonedistat Combination arm compared to the Azacitidine only arm.|||3.620|0.226|=0.888
72348000|NCT02610777|144217394|SUPERIORITY||Absolute Rate Difference|19.231|||=|0.162|TWO_SIDED|95.0|-6.925|45.386||P-value is from an unstratified Cochran-Mantel Haenszel chi-square test.|Cochran-Mantel-Haenszel|||Percentage of Participants With RBCs-transfusion Independence||45.386|-6.925|=0.162
72348001|NCT02610777|144217394|SUPERIORITY||Absolute Rate Difference|20.0|||=|0.454|TWO_SIDED|95.0|-26.381|66.381||P-value is from an unstratified Cochran-Mantel Haenszel chi-square test.|Cochran-Mantel-Haenszel|||Percentage of Participants With Platelet-transfusion Independence||66.381|-26.381|=0.454
72348002|NCT02610777|144217396|SUPERIORITY||Hazard Ratio (HR)|0.79|||=|0.266|TWO_SIDED|95.0|0.521|1.198||P-value is from an unstratified log-rank test.|Log Rank||HR is based on an unstratified Cox proportional hazard regression model with treatment as a factor. HR\<1for the treatment indicates a longer time to PD, Relapse, or Death in the Pevonedistat Combination arm compared to the Azacitidine only arm.|||1.198|0.521|=0.266
72348003|NCT02451917|144217402|NON_INFERIORITY_OR_EQUIVALENCE|A sample size of 34 participants (16randomized to sequence IGlar/INPH and 18randomized to sequence INPH/IGlar) provided 90% power to detect a mean difference of 0.7% in the primary endpoint(A1c), considering a 15% dropout rate and assuming an SD of 0.85%, and a type I error of 5%.||||||0.00045||||||The intention-to-treat population consisted of all randomized participants.|ANOVA|||A sample size of 34 participants (16 randomized to sequence IGlar/INPH and 18 randomized to sequence INPH/IGlar) provided 90% power to detect a mean difference of 0.7% in the primary endpoint (A1c), considering a 15% dropout rate and assuming an SD of 0.85%, and a type I error of 5%. Test for data normality (Kolmogorov-Smirnov statistics) was performed at baseline for each sequence of the therapy.||||0.00045
72348004|NCT02451917|144217403|NON_INFERIORITY_OR_EQUIVALENCE|A sample size of 34 participants (16 randomized to sequence IGlar/INPH and 18 randomized to sequence INPH/IGlar) provided 90% power and assuming an SD of 0.85%, and a type I error of 5%. Test for data normality (Kolmogorov-Smirnov statistics) was performed at baseline for each sequence of the therapy.|number of total events per patient|0.0||||0.35|TWO_SIDED|||||Analysis of covariance (ANOVA) model - total hypoglycemic events per patient during 24 weeks|ANOVA||The calculated value for the estimation parameter was zero, since the best treatment option for those with diabetes is reach a good glycemic control without hypoglycemia.|Analysis of covariance (ANOVA) model - total hypoglycemic events per patient during 24 weeks||||0.35
72348005|NCT02451917|144217403|NON_INFERIORITY_OR_EQUIVALENCE|A sample size of 34 participants (16randomized to sequence IGlar/INPH and 18 randomized to sequence INPH/IGlar) provided 90% power and assuming an SD of 0.85%, and a type I error of 5%.|number of nocturnal events per patient|0.0||||0.047|TWO_SIDED|||||Analysis of covariance (ANOVA) model - number of nocturnal hypoglycemic events per patient during 24 weeks|ANOVA||The calculated value for the estimation parameter was zero, since the best treatment option for those with diabetes is reach a good glycemic control without hypoglycemia.|A sample size of 34 participants (16randomized to sequence IGlar/INPH and 18 randomized to sequence INPH/IGlar) provided 90% power and assuming an SD of 0.85%, and a type I error of 5%.||||0.047
72348006|NCT02451917|144217404|NON_INFERIORITY_OR_EQUIVALENCE|t-test was applied to compare percentages of the time spent in hypoglycemia, hyperglycemia and euglycemia on CGM readings.|||||<|0.05|||||||t-test, 1 sided|||A sample size of 34 participants (16 randomized to sequence IGlar/INPH and 18 randomized to sequence INPH/IGlar) provided 90% power and assuming an SD of 0.85%, and a type I error of 5%.||||<0.05
72348007|NCT02451917|144217405|NON_INFERIORITY_OR_EQUIVALENCE|A sample size of 34 participants (16randomized to sequence IGlar/INPH and 18 randomized to sequence INPH/IGlar) provided 90% power and assuming an SD of 0.85%, and a type I error of 5%.||||||0.668|||||||ANOVA|||A sample size of 34 participants (16randomized to sequence IGlar/INPH and 18 randomized to sequence INPH/IGlar) provided 90% power and assuming an SD of 0.85%, and a type I error of 5%.||||0.668
72348008|NCT02451917|144217406|NON_INFERIORITY_OR_EQUIVALENCE|A sample size of 34 participants (16 randomized to sequence IGlar/INPH and 18r andomized to sequence INPH/IGlar) provided 90% power and assuming an SD of 0.85%, and a type I error of 5%.||||||0.999|||||||ANOVA|||A sample size of 34 participants (16 randomized to sequence IGlar/INPH and 18r andomized to sequence INPH/IGlar) provided 90% power and assuming an SD of 0.85%, and a type I error of 5%.||||0.999
72370170|NCT00838513|144250674|SUPERIORITY_OR_OTHER||Percent of complete TMA response|55.0|||||TWO_SIDED|95.0|32.0|77.0||||||All analyses were based on the pooled data from the two protocols: C08-003A (adult) and C08-003B (adolescent), a similar protocol, for patients \<18 years with aHUS.||77|32|
72370171|NCT00838513|144250675|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.29|||<|0.0001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||All analyses were based on the pooled data from the two protocols: C08-003A (adult) and C08-003B (adolescent), a similar protocol, for patients \<18 years with aHUS.||||<0.0001
72348009|NCT02451917|144217407|NON_INFERIORITY_OR_EQUIVALENCE|A sample size of 34 participants (16randomized to sequence IGlar/INPH and 18 randomized to sequence INPH/IGlar) provided 90% power and assuming an SD of 0.85%, and a type I error of 5%.||||||0.999|||||||ANOVA|||A sample size of 34 participants (16randomized to sequence IGlar/INPH and 18 randomized to sequence INPH/IGlar) provided 90% power and assuming an SD of 0.85%, and a type I error of 5%.||||0.999
72348010|NCT02451917|144217408|NON_INFERIORITY_OR_EQUIVALENCE|A sample size of 34 participants (16randomized to sequence IGlar/INPH and 18 randomized to sequence INPH/IGlar) provided 90% power and assuming an SD of 0.85%, and a type I error of 5%.||||||0.994|||||||ANOVA|||A sample size of 34 participants (16randomized to sequence IGlar/INPH and 18 randomized to sequence INPH/IGlar) provided 90% power and assuming an SD of 0.85%, and a type I error of 5%.||||0.994
72348011|NCT04737278|144217424|OTHER|test of the hypothesis that the score on day 28 is different from the baseline score in the Placebo group|||||<|0.01|||||||t-test, 2 sided|||||||<0.01
72348012|NCT04737278|144217424|OTHER|||||||0.01|||||||t-test, 2 sided|||test of the hypothesis that the score on day 28 is different than the baseline score||||0.01
72348013|NCT04737278|144217425|OTHER|||||||0.15|||||||t-test, 2 sided|||Day 28. Between group comparison was made using ANCOVA accounting for baseline values, no significance at p\<0.05. Within group comparisons were made using the paired Student's t test.||||0.15
72348014|NCT04737278|144217426|OTHER||||||<|0.01|||||||ANCOVA|||||||<0.01
72348015|NCT04737278|144217426|OTHER|||||||0.03|||||||Wilcoxon (Mann-Whitney)|||comparison made between placebo and Cunermuspir at baseline||||0.03
72348016|NCT04737278|144217426|OTHER|||||||0.01|||||||Wilcoxon (Mann-Whitney)|||comparison made at day 28||||0.01
72348017|NCT04737278|144217426|OTHER|||||||0.07|||||||t-test, 2 sided|||comparison between baseline and day 28||||0.07
72348018|NCT04737278|144217427|OTHER|||||||0.54|||||||Fisher Exact|||base line between group comparisons||||0.54
72348019|NCT04737278|144217427|OTHER|||||||0.14|||||||Fisher Exact|||||||0.14
72348020|NCT04737278|144217428|OTHER|||||||0.54|||||||ANCOVA|||||||0.54
72429087|NCT04039503|144369076|SUPERIORITY||Estimate Difference|-38.2|||||TWO_SIDED|95.0|-48.3|-26.1||||||||-26.1|-48.3|
72348021|NCT04737278|144217429|OTHER||||||<|0.01|||||||ANCOVA|||The original report from KGK Synergize/Science did not specify if the results are ANCOVA or a between group comparison at 2ay 28||||<0.01
72348022|NCT04737278|144217430|OTHER|||||||0.31|||||||ANCOVA|||||||0.31
72348023|NCT04737278|144217431|OTHER|||||||0.48|||||||ANCOVA|||||||0.48
72348024|NCT04737278|144217432|OTHER|||||||0.84|||||||ANCOVA|||||||0.84
72348025|NCT04737278|144217433|OTHER|||||||0.63|||||||ANCOVA|||||||0.63
72348026|NCT04737278|144217434|OTHER|||||||0.05|||||||ANCOVA|||||||0.05
72348027|NCT04737278|144217435|OTHER||||||<|0.01|||||||ANCOVA|||||||<0.01
72348028|NCT04737278|144217436|OTHER||||||<|0.01|||||||ANCOVA|||||||<0.01
72348029|NCT04737278|144217437|OTHER|||||||0.48|||||||ANCOVA|||||||0.48
72348030|NCT04737278|144217438|OTHER|||||||0.06|||||||ANCOVA|||||||0.06
72348031|NCT04737278|144217439|OTHER|||||||0.02|||||||ANCOVA|||||||0.02
72348032|NCT04737278|144217440|OTHER|||||||0.03|||||||ANCOVA|||||||0.03
72348033|NCT04737278|144217440|OTHER|||||||0.05|||||||t-test, 2 sided|||comparison of neutrophils from baseline to day 28||||0.05
72348034|NCT04737278|144217441|OTHER||||||<|0.01|||||||ANCOVA|||||||<0.01
72348035|NCT04737278|144217442|OTHER|||||||0.47|||||||Wilcoxon (Mann-Whitney)|||comparison of baseline values||||0.47
72348036|NCT04737278|144217442|OTHER|||||||0.24|||||||Wilcoxon (Mann-Whitney)|||comparison performed on data from day 28||||0.24
72348037|NCT04737278|144217443|OTHER|||||||0.11|||||||Wilcoxon (Mann-Whitney)|||comparison of eosinophil counts at day 28||||0.11
72348038|NCT04737278|144217444|OTHER|||||||0.98|||||||Wilcoxon (Mann-Whitney)|||The day 28 basophil counts on day 28 were compared between the two arms of this study.||||0.98
72348039|NCT04737278|144217445|OTHER|||||||0.025||||||This p value is for the treatment source. Visits (p=0.422) and visits x treatments (p=0.153) did not meet the threshold of significance.|ANOVA|||"All other statistical analyses were performed by KGK Synergize. This site was used to determine that the NLR were normally distributed https://www.gigacalculator.com/calculators/normality-test-calculator.php~Because these data fulfilled the assumptions of ANOVA, the data were analyzed using this site:~http://vassarstats.net/anova2u.html"||||0.025
72348040|NCT04737278|144217446|OTHER|||||||0.06|||||||t-test, 2 sided|||Comparison of blood glucose in the Cunermuspir arm between enrollment baseline and day 28.||||0.06
72348041|NCT04737278|144217446|OTHER|||||||0.04|||||||t-test, 2 sided|||Comparison of enrollment baseline blood glucose and day 28 in the placebo arm||||0.04
72348042|NCT04737278|144217446|OTHER|||||||0.92|||||||ANCOVA|||||||0.92
72348043|NCT04737278|144217447|OTHER|||||||0.51|||||||ANCOVA|||||||0.51
72348044|NCT04737278|144217448|OTHER|||||||0.38|||||||ANCOVA|||||||0.38
72348045|NCT04737278|144217449|OTHER|||||||0.01|||||||ANCOVA|||||||0.01
72348046|NCT04737278|144217450|OTHER|||||||0.23|||||||ANCOVA|||||||0.23
72348047|NCT04737278|144217450|OTHER|||||||0.18|||||||t-test, 2 sided|||||||0.18
72348048|NCT04737278|144217450|OTHER|||||||0.01|||||||t-test, 2 sided|||Blood sodium concentration between baseline and day 28 in the Placebo group.||||0.01
72348049|NCT04737278|144217451|OTHER|||||||0.58|||||||ANCOVA|||||||0.58
72348050|NCT04737278|144217451|OTHER||||||<|0.001|||||||t-test, 2 sided|||comparison of blood potassium concentration upon enrollment and day 28 in the Cunermuspir participants||||<0.001
72348051|NCT04737278|144217451|OTHER||||||<|0.001|||||||t-test, 2 sided|||comparison of blood potassium concentrations from enrollment to day 28 in participants in the Placebo arm.||||<0.001
72348052|NCT04737278|144217452|OTHER|||||||0.87|||||||ANCOVA|||||||0.87
72348053|NCT04737278|144217452|OTHER|||||||0.003|||||||t-test, 2 sided|||comparison between baseline and day 28 chloride concentrations in the Cunermuspir group||||0.003
72348054|NCT04737278|144217452|OTHER|||||||0.003|||||||t-test, 2 sided|||comparison of blood chloride concentrations between baseline and day 28 in Placebo Arm participants||||0.003
72348055|NCT04737278|144217453|OTHER|||||||0.36|||||||Wilcoxon (Mann-Whitney)|||Bilirubin concentrations between Placebo and Cunermuspir compared at day 28||||0.36
72348056|NCT04737278|144217453|OTHER|||||||0.72|||||||Wilcoxon (Mann-Whitney)|Wilcoxon Signed-Rank||comparison of bilirubin concentrations between baseline and day 28 in the Cunermuspir Arm||||0.72
72429088|NCT04039503|144369076|SUPERIORITY||Estimate Difference|-49.3|||||TWO_SIDED|95.0|-57.7|-39.4||||||||-39.4|-57.7|
72348057|NCT04737278|144217453|OTHER|||||||0.35|||||||Wilcoxon (Mann-Whitney)|||bilirubin concentrations compared between baseline and Day 28 in the Placebo Arm||||0.35
72348058|NCT04737278|144217454|OTHER|||||||0.95|||||||Wilcoxon (Mann-Whitney)|||||||0.95
72348059|NCT04737278|144217454|OTHER|||||||0.4|||||||Wilcoxon (Mann-Whitney)|||comparison between baseline and day 28 values in Cunermuspir group||||0.4
72348060|NCT04737278|144217454|OTHER|||||||0.8|||||||Wilcoxon (Mann-Whitney)|||comparison between baseline and day 28 values for the Placebo Arm||||0.8
72348061|NCT04737278|144217455|OTHER|||||||0.62|||||||Wilcoxon (Mann-Whitney)|||comparison of AST enzyme activity in blood on day 28 between Cunermuspir and Placebo||||0.62
72348062|NCT04737278|144217455|OTHER|||||||0.24|||||||Wilcoxon (Mann-Whitney)|||baseline to day 28 comparison||||0.24
72348063|NCT04737278|144217455|OTHER|||||||0.11|||||||Wilcoxon (Mann-Whitney)|||baseline to day 28 comparison of AST activity in Placebo group||||0.11
72348064|NCT04737278|144217456|OTHER|||||||0.11||||||Comparison of GGT activities in blood of two arms: Cunermuspir and Placebo on Day 28|Wilcoxon (Mann-Whitney)|||comparison between placebo and Cunermuspir at day 28||||0.11
72348065|NCT04737278|144217456|OTHER|||||||0.01|||||||Wilcoxon Signed Rank|||Comparison of GGT activities in participants' blood at baseline and on day 28||||0.01
72348066|NCT04737278|144217456|OTHER|||||||0.97|||||||Wilcoxon Signed-Rank|||Comparison of GGT activity in blood between Placebo Arm participants at baseline and on day 28||||0.97
72348067|NCT04737278|144217457|OTHER|||||||0.03|||||||ANCOVA|||Between group comparisons were made using ANCOVA||||0.03
72348068|NCT04737278|144217457|OTHER|||||||0.1|||||||t-test, 2 sided|||comparison of baseline with day 28||||0.10
72348069|NCT04737278|144217457|OTHER|||||||0.89|||||||t-test, 2 sided|||comparison between baseline and day 28 serum copper concentrations in the Placebo Arm||||0.89
72348070|NCT02255461|144217503|OTHER|Ordinal logistic regression model was built for outcome neutropenia (0/1/2). Explanatory variable AUC was transformed by dividing by 100.|Odds Ratio (OR)|1.06|||||TWO_SIDED|95.0|0.97|1.15||||||||1.15|0.97|
72429089|NCT04039503|144369079|SUPERIORITY||Odds Ratio (OR)|12.22|||<|0.001|TWO_SIDED|95.0|3.93|38.0|||Regression, Logistic|||||38.00|3.93|<0.001
72348071|NCT02255461|144217504|OTHER|Ordinal logistic regression model was built for outcome lymphopenia (0/1/2). Explanatory variable AUC was transformed by dividing by 100.|Odds Ratio (OR)|1.05|||||TWO_SIDED|95.0|0.97|1.15||||||||1.15|0.97|
72348072|NCT02255461|144217505|OTHER|Ordinal logistic regression model was built for outcome leukopenia (0/1/2). Explanatory variable AUC was transformed by dividing by 100.|Odds Ratio (OR)|1.1|||||TWO_SIDED|95.0|1.01|1.2||||||||1.20|1.01|
72348073|NCT01504412|144217538|SUPERIORITY||Hazard Ratio (HR)|-0.42||||0.1995|TWO_SIDED|95.0|-0.99|0.15||Dunnett method was used for adjustment of multiple testing.|ANCOVA|||||0.15|-0.99|0.1995
72348074|NCT01504412|144217538|SUPERIORITY||Hazard Ratio (HR)|-0.37||||0.2886|TWO_SIDED|95.0|-0.93|0.2||Dunnett method was used for adjustment of multiple testing.|ANCOVA|||||0.20|-0.93|0.2886
72348075|NCT01504412|144217538|SUPERIORITY||Hazard Ratio (HR)|-0.3||||0.4704|TWO_SIDED|95.0|-0.87|0.27||Dunnett method was used for adjustment of multiple testing.|ANCOVA|||||0.27|-0.87|0.4704
72348076|NCT01504412|144217539|SUPERIORITY||Least squares mean difference|-5.2||||0.0691|TWO_SIDED|95.0|-10.8|0.4|||ANCOVA|||This analysis assessed placebo vs DS-5565 10 mg/day for the visual analog scale.||0.4|-10.8|0.0691
72348077|NCT01504412|144217539|SUPERIORITY||Least squares mean difference|-5.4||||0.0577|TWO_SIDED|95.0|-10.9|0.2|||ANCOVA|||This analysis assessed placebo vs DS-5565 20 mg/day for the visual analog scale.||0.2|-10.9|0.0577
72348078|NCT01504412|144217539|SUPERIORITY||Least squares mean difference|-7.4||||0.0093|TWO_SIDED|95.0|-13.0|-1.8|||ANCOVA|||This analysis assessed placebo vs DS-5565 30 mg/day for the visual analog scale.||-1.8|-13.0|0.0093
72348079|NCT05224453|144217540|SUPERIORITY|Parametric t test|Mean Difference (Final Values)|-5.0|||<|0.05|TWO_SIDED|95.0|-6.21|-3.78|||t-test, 2 sided|||||-3.78|-6.21|<0.05
72348080|NCT05224453|144217541|SUPERIORITY|Parametric t test|Mean Difference (Final Values)|-3.7|||<|0.05|TWO_SIDED|95.0|-6.53|-0.86|||t-test, 2 sided|||||-0.86|-6.53|<0.05
72348081|NCT05224453|144217541|SUPERIORITY|Parametric t test|Mean Difference (Final Values)|-1.7|||<|0.05|TWO_SIDED|95.0|-3.84|0.44|||t-test, 2 sided|||||0.44|-3.84|<0.05
72348082|NCT02381015|144217581|SUPERIORITY_OR_OTHER_LEGACY|||||||0.29|||||||Chi-squared|||||||0.29
72348083|NCT02381015|144217582|SUPERIORITY_OR_OTHER_LEGACY|||||||0.35|||||||Chi-squared|||||||0.35
72348084|NCT02381015|144217583|SUPERIORITY_OR_OTHER_LEGACY|||||||0.29|||||||Chi-squared|||||||0.29
72348085|NCT02381015|144217584|SUPERIORITY_OR_OTHER_LEGACY|||||||0.49|||||||Kruskal-Wallis|||||||0.49
72348086|NCT02381015|144217585|OTHER||Beta|93.5|STANDARD_ERROR_OF_MEAN|1.55||0.42|TWO_SIDED||||||ANOVA|||The statistical analysis shows the relation between risk given and risk recall at the immediate post results assessment for the total number of participants.||||0.42
72348087|NCT02381015|144217586|OTHER||Beta|94.7|STANDARD_ERROR_OF_MEAN|2.93||0.33|TWO_SIDED||||||ANOVA|||||||0.33
72348088|NCT01449006|144217587|SUPERIORITY_OR_OTHER|||||||0.05||||||This pilot study was conducted to generate effect sizes for a potential larger investigation. The study design and small sample size had limited power to detect a statistically significant effect at p\<0.05, so no p-value threshold was strictly set.|Mixed Models Analysis|41 data points included (control n=14; maraviroc: n=27); n=1 control did not attend 12-month visit.||The primary outcome was analysed using a mixed-effect regression model with arm and time as fixed linear effects, arm\*time interaction as a non-linear fixed effect and participant as a random effect to account for participant attrition.||||0.05
72348089|NCT01449006|144217587|SUPERIORITY_OR_OTHER||Cohen's d|0.77|||||TWO_SIDED|90.0|-0.19|1.71|||||Positive value reflects improved neurocognitive functioning in maraviroc arm compared to control arm.|Clinical relevance of the effect size observed at 6-months was assessed by generating Cohen's d statistic and 90% confidence interval (CI) around the estimate.||1.71|-0.19|
72348090|NCT01449006|144217587|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.55|||||TWO_SIDED|90.0|-0.47|1.55|||||Positive value reflects improved neurocognitive functioning in maraviroc arm compared to control arm.|Clinical relevance of the effect size observed at 12-months was assessed by generating Cohen's d statistic and 90%CI around the estimate.||1.55|-0.47|
72348091|NCT01449006|144217588|SUPERIORITY_OR_OTHER|||||||0.82|||||||ANOVA|||Change in CSF neopterin levels was analysed using repeated-measures ANOVA with arm, time, and arm\*time interaction as fixed effects.||||0.82
72429090|NCT04039503|144369079|SUPERIORITY||Odds Ratio (OR)|32.36|||<|0.001|TWO_SIDED|95.0|10.52|99.49|||Regression, Logistic|||||99.49|10.52|<0.001
72348092|NCT01449006|144217589|SUPERIORITY_OR_OTHER|||||||0.49|||||||ANOVA|||Change in NAA/H20 levels were analysed using repeated-measures ANOVA with arm, time, and arm\*time interaction as fixed effects.||||0.49
72348093|NCT01449006|144217589|SUPERIORITY_OR_OTHER|||||||0.94|||||||ANOVA|||Change in Cr/H20 levels were analysed using repeated-measures ANOVA with arm, time, and arm\*time interaction as fixed effects.||||0.94
72348094|NCT01449006|144217589|SUPERIORITY_OR_OTHER|||||||0.8|||||||ANOVA|||Change in Cho/H20 levels were analysed using repeated-measures ANOVA with arm, time, and arm\*time interaction as fixed effects.||||0.80
72348095|NCT01449006|144217589|SUPERIORITY_OR_OTHER|||||||0.72|||||||ANOVA|||Change in mIo/H20 levels were analysed using repeated-measures ANOVA with arm, time, and arm\*time interaction as fixed effects.||||0.72
72348096|NCT01449006|144217590|SUPERIORITY_OR_OTHER|||||||0.95|||||||ANOVA|||Change in NAA/H20 levels were analysed using repeated-measures ANOVA with arm, time, and arm\*time interaction as fixed effects.||||0.95
72348097|NCT01449006|144217590|SUPERIORITY_OR_OTHER|||||||0.66|||||||ANOVA|||Change in Cr/H20 levels were analysed using repeated-measures ANOVA with arm, time, and arm\*time interaction as fixed effects.||||0.66
72348098|NCT01449006|144217590|SUPERIORITY_OR_OTHER|||||||0.56|||||||ANOVA|||Change in Cho/H20 levels were analysed using repeated-measures ANOVA with arm, time, and arm\*time interaction as fixed effects.||||0.56
72348099|NCT01449006|144217590|SUPERIORITY_OR_OTHER|||||||0.29|||||||ANOVA|||Change in mIo/H20 levels were analysed using repeated-measures ANOVA with arm, time, and arm\*time interaction as fixed effects.||||0.29
72348100|NCT01449006|144217590|SUPERIORITY_OR_OTHER|||||||0.95|||||||ANOVA|||Change in Glx/H20 levels were analysed using repeated-measures ANOVA with arm, time, and arm\*time interaction as fixed effects.||||0.95
72348101|NCT03350815|144217591|OTHER|Statistical hypothesis tests were not performed for this study|Odds Ratio (OR)|0.79|||||TWO_SIDED|95.0|0.28|2.25||No P value as no hypothesis was tested|Regression, Logistic|||Statistical analysis (logistic regression) of ASDAS inactive disease response by visit - in Treatment Period 2 (nonresponder imputation)||2.25|0.28|
72348102|NCT03350815|144217592|OTHER|Statistical hypothesis tests were not performed for this study|Odds Ratio (OR)|2.08|||||TWO_SIDED|95.0|0.5|8.66||No P value as no hypothesis was tested|Regression, Logistic|||Statistical analysis (logistic regression) of reduction in ASDAS \>= 1.1 response by visit - in Treatment Period 2 (nonresponder imputation)||8.66|0.50|
72348103|NCT03350815|144217593|OTHER|Statistical hypothesis tests were not performed for this study|Least Square Mean of Treatment Differenc|0.23|STANDARD_ERROR_OF_MEAN|0.263|||TWO_SIDED|95.0|-0.29|0.75||Least squares means (LSMs) of the treatment groups, LSM treatment difference and 95% confidence interval for treatment difference are from mixed-effects model repeated measures (MMRM) with treatment, visit and TNF-alpha inhibitor status as factors|Mixed Models Analysis|||Statistical analysis of total BASDAI change from Week 16 using MMRM - in Treatment Period 2 (FAS)||0.75|-0.29|
72348104|NCT03350815|144217594|OTHER|Statistical hypothesis tests were not performed for this study|Odds Ratio (OR)|1.28|||||TWO_SIDED|95.0|0.5|3.24||Odds ratio and 95% confidence interval for odds ratio are from a logistic regression model with treatment (2 treatment groups), TNF-alpha inhibitor status (naive, inadequate responder) and Week 16 body weight (kg) as explanatory variables.|Regression, Logistic|||Statistical analysis (logistic regression) of BASDAI50 response by visit - in Treatment Period 2 (nonresponder imputation) (FAS)||3.24|0.50|
72348105|NCT03350815|144217595|OTHER|Statistical hypothesis tests were not performed for this study|Odds Ratio (OR)|0.87|||||TWO_SIDED|95.0|0.43|1.73||Odds ratio and 95% confidence interval for odds ratio are from a logistic regression model with treatment (2 treatment groups), TNF-alpha inhibitor status (naive, inadequate responder) and Week 16 body weight (kg) as explanatory variables|Regression, Logistic|||Statistical analysis (logistic regression) of BASDAI20 response by visit - in Treatment Period 2 (nonresponder imputation) (FAS)||1.73|0.43|
72348106|NCT03350815|144217596|OTHER|Statistical hypothesis tests were not performed for this study|Odds Ratio (OR)|1.31|||||TWO_SIDED|95.0|0.49|3.46||Odds ratio and 95% confidence interval for odds ratio are from a logistic regression model with treatment (2 treatment groups), TNF-alpha inhibitor status (naive, inadequate responder) and Week 16 body weight (kg) as explanatory variables.|Regression, Logistic|||Statistical analysis (logistic regression) of ASAS40 response by visit - in Treatment Period 2 (nonresponder imputation) (FAS)||3.46|0.49|
72348107|NCT03350815|144217597|OTHER|Statistical hypothesis tests were not performed for this study|Odds Ratio (OR)|1.03|||||TWO_SIDED|95.0|0.44|2.41||Odds ratio and 95% confidence interval for odds ratio are from a logistic regression model with treatment (2 treatment groups), TNF-alpha inhibitor status(naive, inadequate responder) and Week 16 body weight (kg) as explanatory variables.|Regression, Logistic|||Statistical analysis (logistic regression) of ASAS partial remission response by visit - in Treatment Period 2 (nonresponder imputation) (FAS)||2.41|0.44|
72348108|NCT03350815|144217598|OTHER|Statistical hypothesis tests were not performed for this study|Mean Difference (Final Values)|0.13|||||TWO_SIDED|95.0|-0.74|1.01||Least squares means (LSMs) of the treatment groups, LSM treatment difference and 95% confidence interval for treatment difference are from mixed-effects model repeated measures (MMRM) with treatment, visit and TNF-alpha inhibitor status as factors|Regression, Logistic|||Statistical analysis of change from Week 16 in ASAS-Health Index using MMRM by visit - in Treatment Period 2 (FAS)||1.01|-0.74|
72348109|NCT03350815|144217599|OTHER|Statistical hypothesis tests were not performed for this study|Mean Difference (Final Values)|-1.0|||||TWO_SIDED|95.0|-3.62|1.61||Least squares means (LSMs) of the treatment groups, LSM treatment difference and 95% confidence interval for treatment difference are from mixed-effects model repeated measures (MMRM) with treatment, visit and TNF-alpha inhibitor status as factors|Regression, Logistic|||||1.61|-3.62|
72348110|NCT02936843|144217612|SUPERIORITY|||||||0.41|||||||t-test, 2 sided|2-sided||TTEST, two sided||||0.41
72348111|NCT01979952|144217639|SUPERIORITY_OR_OTHER||Adjusted mean difference|3.176|STANDARD_ERROR_OF_MEAN|6.237|||TWO_SIDED|95.0|-9.227|15.579|||ANCOVA|As per the Clinical Trial Protocol, this is an exploratory trial hence p-values were not calculated.||Analysis of covariance (ANCOVA) model with treatment as fixed effect and baseline HRCT QLF score as covariate||15.579|-9.227|
72348112|NCT01979952|144217640|SUPERIORITY_OR_OTHER||Adjusted mean difference|2.519|STANDARD_ERROR_OF_MEAN|6.3829|||TWO_SIDED|95.0|-10.258|15.296|||ANCOVA|As per the Clinical Trial Protocol, this is an exploratory trial hence p-values were not calculated||Analysis of covariance (ANCOVA) model with treatment as fixed effect and baseline HRCT QLF score as covariate||15.296|-10.258|
72429091|NCT04039503|144369079|SUPERIORITY||Odds Ratio (OR)|56.26|||<|0.001|TWO_SIDED|95.0|18.27|173.26|||Regression, Logistic|||||173.26|18.27|<0.001
72348113|NCT01979952|144217641|SUPERIORITY_OR_OTHER||Adjusted mean difference|69.0|STANDARD_ERROR_OF_MEAN|39.182|||TWO_SIDED|95.0|-8.74|146.75|||Mixed Models Analysis|As per the Clinical Trial Protocol, this is an exploratory trial hence p-values were not calculated.||Mixed Model for Repeated Measures (MMRM) model with fixed effects for treatment, visit, gender, age, height, treatment-by-visit, baseline FVC, baseline FVC-by-visit and random effect for patient. Within-patient errors are modelled by unstructured covariance matrix.||146.75|-8.74|
72348114|NCT01979952|144217642|SUPERIORITY_OR_OTHER||Adjusted mean difference|2.36|||||TWO_SIDED|95.0|-0.29|5.0|||Mixed Models Analysis|As per the Clinical Trial Protocol, this is an exploratory trial hence p-values were not calculated.||MMRM model with fixed effects for treatment, visit, gender, age, height, treatment-by-visit, baseline FVC, baseline FVC-by-visit and random effect for patient. Within-patient errors are modelled by unstructured covariance matrix.||5.00|-0.29|
72348115|NCT01979952|144217644|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.05|STANDARD_ERROR_OF_MEAN|2.434|||TWO_SIDED|95.0|-4.89|4.79|||Mixed Models Analysis|||MMRM model included treatment, visit, baseline value, treatment-by-visit and baseline-by-visit as fixed effects and patient as random effect. Unstructured covariance was assumed for within patient variation||4.79|-4.89|
72348116|NCT01979952|144217645|SUPERIORITY_OR_OTHER||Adjusted mean difference|17.94|STANDARD_ERROR_OF_MEAN|16.19|||TWO_SIDED|95.0|-14.21|50.09|||Mixed Models Analysis|||MMRM model included treatment, visit, baseline value, treatment-by-visit and baseline-by-visit as fixed effects and patient as random effect. Unstructured covariance was assumed for within patient variation||50.09|-14.21|
72348117|NCT01979952|144217646|SUPERIORITY_OR_OTHER||Adjusted mean difference|4.89|||||TWO_SIDED|95.0|-1.47|11.25|||Mixed Models Analysis|||MMRM model included treatment, visit, baseline value, treatment-by-visit and baseline-by-visit as fixed effects and patient as random effect. Unstructured covariance was assumed for within patient variation||11.25|-1.47|
72348118|NCT05438576|144217651|SUPERIORITY||Odds Ratio (OR)|2.12||||0.032|TWO_SIDED|95.0|1.05|4.27|||Regression, Logistic|||||4.27|1.05|0.032
72348119|NCT05438576|144217656|SUPERIORITY||Odds Ratio (OR)|1.1||||0.621|TWO_SIDED|95.0|0.74|1.64|||Regression, Logistic|||||1.64|0.74|0.621
72348120|NCT00465088|144217670|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||alpha = 0.05|Mixed Models Analysis|||An n = 81 for niacin extended-release with simvastatin and n = 54 for atorvastatin would provide \> 99% power to detect a 13% increase in HDL-C with niacin extended-release with simvastatin relative to atorvastatin, assuming an SD of 16%||||<0.001
72348121|NCT00555672|144217701|SUPERIORITY_OR_OTHER||Objective Response Rate (ORR) (percent)|27.3|||||TWO_SIDED|95.0|13.3|45.5|||Fisher Exact|Exact Method based on the F Distribution.||||45.5|13.3|
72348122|NCT04759157|144217705|SUPERIORITY|||||||0.3|||||||mixed model|||||||.30
72348123|NCT04759157|144217706|SUPERIORITY||Mean Difference (Net)|-2.6|STANDARD_ERROR_OF_MEAN|2.05||0.206|TWO_SIDED|95.0|-6.63|1.43|||Mixed Models Analysis||This estimate is comparing intervention to control from baseline to 3 month for both patients and partners|We conducted multilevel models evaluating sleep disturbance score by assessment, group and patient versus partner status.||1.43|-6.63|.206
72348124|NCT04765202|144217721|SUPERIORITY||Percentage Difference|14.3||||1|TWO_SIDED|95.0|-11.64|40.21|||Fisher Exact||Difference was calculated as (percent area of wound closure in SOMA Tx site) - ((percent area of wound closure in AG Tx site). 95% CI was derived using the normal approximation to binomial distribution.|Comparison of complete wound closure without additional autografting at Month 2 in AG TX site and SOMA TX site in Cohort 1 Group 1.||40.21|-11.64|1.0000
72348125|NCT04765202|144217721|SUPERIORITY||Percentage Difference|0.0|||||TWO_SIDED|95.0|0.0|0.0|||||Difference was calculated as (percent area of wound closure in SOMA Tx site) - ((percent area of wound closure in AG Tx site). 95% CI was derived using the normal approximation to binomial distribution.|Comparison of complete wound closure without additional autografting at Month 2 in AG TX site and SOMA TX site in Cohort 1 Group 2.||0|0|
72348126|NCT02305238|144217725|SUPERIORITY_OR_OTHER_LEGACY||Least Square (LS) mean difference|-0.4|||||TWO_SIDED|95.0|-3.8|3.0||||||||3.0|-3.8|
72348127|NCT02305238|144217726|SUPERIORITY_OR_OTHER_LEGACY||Mantel-Haenszel (MH) adjusted difference|-0.9|||||TWO_SIDED|95.0|-5.7|4.0||||||||4.0|-5.7|
72348128|NCT02305238|144217727|SUPERIORITY_OR_OTHER_LEGACY||MH adjusted difference|-1.4|||||TWO_SIDED|95.0|-12.7|9.8||||||||9.8|-12.7|
72348129|NCT02305238|144217728|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-5.8|||||TWO_SIDED|95.0|-24.3|12.7||||||||12.7|-24.3|
72348130|NCT02305238|144217729|SUPERIORITY_OR_OTHER_LEGACY||MH adjusted difference|1.0|||||TWO_SIDED|95.0|-10.6|12.7||||||||12.7|-10.6|
72348131|NCT04677504|144217761|SUPERIORITY||Hazard Ratio (HR)|0.76|||||TWO_SIDED|95.0|0.51|1.14|||Regression, Cox|||"Stratified analysis. Stratification factors are: Location of primary tumor (iCCA vs.~eCCA vs. GBC), Geographic region (Asia vs. Rest of the World)."||1.14|0.51|
72348132|NCT04677504|144217762|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.8857|TWO_SIDED|95.0|0.64|1.47|||Log Rank|||"Stratified analysis. Stratification factors are: Location of primary tumor (iCCA vs.~eCCA vs. GBC), Geographic region (Asia vs. Rest of the World)."||1.47|0.64|0.8857
72348133|NCT04677504|144217766|SUPERIORITY|Stratified analysis. Stratification factors are: Location of primary tumor (iCCA vs. eCCA vs. GBC), Geographic region (Asia vs. Rest of the World).|Hazard Ratio (HR)|1.56|||||TWO_SIDED|95.0|0.93|2.63|||Regression, Cox|||Quality of Life||2.63|0.93|
72348134|NCT04677504|144217766|SUPERIORITY|Stratified analysis. Stratification factors are: Location of primary tumor (iCCA vs. eCCA vs. GBC), Geographic region (Asia vs. Rest of the World).|Hazard Ratio (HR)|0.81|||||TWO_SIDED|95.0|0.48|1.36|||Regression, Cox|||Physical Function Scale||1.36|0.48|
72348135|NCT04677504|144217766|SUPERIORITY|Stratified analysis. Stratification factors are: Location of primary tumor (iCCA vs. eCCA vs. GBC), Geographic region (Asia vs. Rest of the World).|Hazard Ratio (HR)|1.12|||||TWO_SIDED|95.0|0.68|1.85|||Regression, Cox|||Role Function Scale||1.85|0.68|
72348136|NCT00870545|144217841|SUPERIORITY_OR_OTHER|||||||0.003||||||P values less than or equal to .05 were considered statistically significant, and those between .05 and .10 were considered to document trends that approached, but did not attain, statistical significance.|Mixed Models Analysis|||Change in scores measured across three time points (baseline, 6 and 12 months)||||.003
72348137|NCT00870545|144217842|SUPERIORITY_OR_OTHER|||||||0.2||95.0||||P values less than or equal to .05 were considered statistically significant, and those between .05 and .10 were considered to document trends that approached, but did not attain, statistical significance.|Mixed Models Analysis|||Analysis was change in score over time (baseline, 6 and 12 months)||||.20
72348138|NCT00870545|144217843|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P values less than or equal to .05 were considered statistically significant, and those between .05 and .10 were considered to document trends that approached, but did not attain, statistical significance.|Mixed Models Analysis|||Change in scores measured across three time points (baseline, 6 and 12 months)||||<.001
72348139|NCT00870545|144217844|SUPERIORITY_OR_OTHER|||||||0.26||95.0||||P values less than or equal to .05 were considered statistically significant, and those between .05 and .10 were considered to document trends that approached, but did not attain, statistical significance.|Mixed Models Analysis|||Analysis was change in score over time (baseline, 6 months, 12 months)||||.26
72348140|NCT00870545|144217845|SUPERIORITY_OR_OTHER|||||||0.04||95.0||||P values less than or equal to .05 were considered statistically significant, and those between .05 and .10 were considered to document trends that approached, but did not attain, statistical significance.|Mixed Models Analysis|||Analysis was change in scores over time (baseline, 6 months, and 12 months)||||.04
72348141|NCT00870545|144217846|SUPERIORITY_OR_OTHER|||||||0.1||95.0||||P values less than or equal to .05 were considered statistically significant, and those between .05 and .10 were considered to document trends that approached, but did not attain, statistical significance.|Mixed Models Analysis|||Analysis was change in score over time (baseline, 6 months, and 12 months)||||.10
72348142|NCT00660179|144217920|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.704||||0.0108|TWO_SIDED|97.5|0.516|0.96|||Log Rank|||||0.960|0.516|0.0108
72348143|NCT00660179|144217920|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.547|||<|0.0001|TWO_SIDED|97.5|0.392|0.762|||Log Rank|||||0.762|0.392|<0.0001
72348144|NCT00660179|144217921|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.669||||0.0146|TWO_SIDED|97.5|0.462|0.97|||Log Rank|||||0.970|0.462|0.0146
72348145|NCT00660179|144217921|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.5|||<|0.0001|TWO_SIDED|97.5|0.335|0.747|||Log Rank|||||0.747|0.335|<0.0001
72348146|NCT00660179|144217922|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.971||||0.9249|TWO_SIDED|97.5|0.477|1.976|||Log Rank|||||1.976|0.477|0.9249
72348147|NCT00660179|144217922|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.638||||0.2037|TWO_SIDED|97.5|0.287|1.418|||Log Rank|||||1.418|0.287|0.2037
72348148|NCT00660179|144217923|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.046||||0.8312|TWO_SIDED|97.5|0.653|1.673|||Log Rank|||||1.673|0.653|0.8312
72348149|NCT00660179|144217923|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.771||||0.2509|TWO_SIDED|97.5|0.464|1.282|||Log Rank|||||1.282|0.464|0.2509
72348150|NCT02974257|144217929|OTHER|Linear mixed-effects model with an independent variance-covariance matrix to account for the correlation of within-patient repeated measures was used and linear contrasts were used to estimate the mean difference between treatment arms at 48 hours.|Mean Difference (Final Values)|1.5||||0.9|TWO_SIDED|95.0|-3.1|6.1||Global p-value from the mixed model.|Mixed Models Analysis|If patients died before 48 hours lactate levels were imputed by carrying forward the last known value before the event with a 20% increase||||6.1|-3.1|0.9
72348151|NCT02974257|144217930|OTHER||Mean Difference (Final Values)|-0.36||||0.42|TWO_SIDED|95.0|-1.29|0.56|||Regression, Linear|||AUC-VO2 normally distributed, used a linear regression model to compare mean AUC-VO2 between treatment groups controlling for average temperature.||0.56|-1.29|0.42
72348152|NCT02974257|144217931|OTHER||Mean Difference (Final Values)|-0.3||||0.07|TWO_SIDED|95.0|-0.9|0.3||Mixed model controlling for repeated measures within patients used to get a mean difference in PDH specific activity between thiamine and placebo groups at 48 hours.|Mixed Models Analysis|P-value is the global p-value from the mixed model.||||0.3|-0.9|0.07
72348153|NCT03906071|144217958|SUPERIORITY||Hazard Ratio (HR)|0.86||||0.144|TWO_SIDED|95.0|0.7|1.05||The p-value is based on a unstratified log-rank test. (2-Sided)|Log Rank||Based on the unstratified cox proportional hazards model.|||1.05|0.70|0.144
72348154|NCT04808141|144218011|EQUIVALENCE|For a power of 80% and a two-sided 0.05 significance level, we calculated that 102 individuals would be necessary to detect a 10-point difference between the two groups. To guarantee that the study was adequately powered to detect equivalence, a posteriori analysis was conducted using the Two One-Sided Test (TOST) methodology (simulation-based power analysis).|Median Difference (Net)|-0.55||||0.412|TWO_SIDED|95.0|-2.42|5.81||the threshold for statistical significance was set at 0.05.|Quantile mixed-effects model|robust method on the medians||||5.81|-2.42|0.412
72348155|NCT04808141|144218011|EQUIVALENCE||Odds Ratio (OR)|0.926||||0.849|TWO_SIDED|95.0|0.42|2.05||The threshold for statistical analysis was set at 0.05.|Regression, Logistic|||||2.05|0.42|0.849
72348156|NCT04808141|144218012|EQUIVALENCE||Median Difference (Net)|0.3||||0.666|TWO_SIDED|95.0|-0.71|1.1||The threshold for statistical significance was set at 0.05.|Quantile mixed-effects model|robust method on the medians||||1.10|-0.71|0.666
72348157|NCT04808141|144218013|EQUIVALENCE||Median Difference (Net)|-2.62||||0.122|TWO_SIDED|95.0|-14.87|4.8||The threshold for statistical significance was set at 0.05.|Quantile mixed-effects model|Robust test on the medians||||4.80|-14.87|0.122
72348158|NCT04808141|144218014|EQUIVALENCE||Median Difference (Net)|3.32||||0.788|TWO_SIDED|95.0|-3.11|5.9||The threshold for statistical significance was set at 0.05.|Quantile mixed-effects model|Robust method on the medians||||5.90|-3.11|0.788
72348159|NCT04808141|144218015|EQUIVALENCE||Odds Ratio (OR)|0.92||||0.081|TWO_SIDED|95.0|0.0|1.23||The threshold for statistical significance was set at 0.05.|Regression, Logistic|LR to assess the odds between groups for consuming analgesics at 8 weeks using the CG as a reference.||||1.23|0.00|0.081
72348160|NCT04808141|144218015|EQUIVALENCE||Odds Ratio (OR)|0.26||||0.985|TWO_SIDED|95.0|0.0|1.71||The threshold for statistical significance was set at 0.05.|Regression, Logistic|LR to assess the odds between groups for consuming opioids at 8 weeks using the CG as a reference.||||1.71|0.00|0.985
72348161|NCT04808141|144218016|EQUIVALENCE||Median Difference (Net)|-0.42||||0.871|TWO_SIDED|95.0|-2.1|1.78||the threshold for statistical significance was set at 0.05.|Quantile mixed-effects model|Robust method on the medians||||1.78|-2.10|0.871
72348162|NCT04808141|144218017|EQUIVALENCE||Median Difference (Final Values)|0.43||||0.36|TWO_SIDED|95.0|-0.59|1.59||The threshold for statistical significance was set at 0.05.|Quantile mixed-effects model|Robust method on the medians||||1.59|-0.59|0.360
72348163|NCT04808141|144218018|EQUIVALENCE||Mean Difference (Final Values)|0.09||||0.837|TWO_SIDED|||||The threshold for statistical significance was set at 0.05.|t-test, 2 sided|||||||0.837
72348164|NCT04808141|144218019|EQUIVALENCE||Z-score|-1.28||||0.886|TWO_SIDED|||||The threshold for statistical significance was 0.05.|Ordinal Regression|||||||0.886
72348165|NCT04808141|144218020|EQUIVALENCE||Median Difference (Net)|1.33||||0.095|TWO_SIDED|95.0|-2.2|2.46||The threshold for statistical significance was set at 0.05.|Quantile mixed-effects model|Robust method on the medians||||2.46|-2.20|0.095
72348166|NCT04808141|144218022|EQUIVALENCE||Mean Difference (Final Values)|65.8||||0.662|TWO_SIDED|||||The threshold for statistical significance was set at 0.05.|Wilcoxon (Mann-Whitney)|||||||0.662
72348167|NCT04808141|144218023|EQUIVALENCE||Median Difference (Net)|-1.97||||0.246|TWO_SIDED|95.0|-12.69|3.33|||Quantile mixed-effects model|Robust method on the medians||||3.33|-12.69|0.246
72348168|NCT04808141|144218024|EQUIVALENCE||Median Difference (Net)|-0.73||||0.408|TWO_SIDED|95.0|-6.5|2.69||the threshold for statistical significance was set at 0.05|Quantile mixed-effects model|Robust method on the medians.||||2.69|-6.50|0.408
72348169|NCT04808141|144218025|EQUIVALENCE||Median Difference (Net)|0.35||||0.65|TWO_SIDED|95.0|-6.22|9.87||The threshold for statistical significance was set at 0.05.|Quantile mixed-effects model|Robust method on the medians||||9.87|-6.22|0.650
72348170|NCT04808141|144218026|EQUIVALENCE||Difference in proportions|18.6||||0.019|TWO_SIDED||||||Chi-squared|||||||0.019
72348171|NCT00394706|144218083|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.2||||0.59|TWO_SIDED|95.0|-1.1|0.7||Two sided test with an a priori threshold of 0.05 for declaring statistical significance.|Mixed Models Analysis||Estimate of the rate of MRS \<= 3 in Analyze Later arm minus rate in Analyze early arm.|Comparison of the rates of MRS \<=3 in Analyze Early vs. Analyze Later arms using a linear mixed effect model with an identity link and random effects to account for the cluster randomization.||0.7|-1.1|0.59
72348172|NCT00394706|144218083|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.1||||0.71|TWO_SIDED|95.0|-1.1|0.8||To adjust for group sequential monitoring, the point estimate was bias-adjusted (Whitehead 1986) and confidence intervals and P values calculated from the maximum likelihood based ordering of the outcome(Emerson and Fleming, 1990)|t-test, 2 sided||Estimate of the rate of MRS \<= 3 in the active ITD arm minus the rate in the Sham ITD arm.|Comparison of the rates of MRS \<=3 in Active ITD and Sham treatment arms, adjusted for sequential monitoring.||0.8|-1.1|0.71
72348173|NCT00394706|144218084|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.1||||0.92|TWO_SIDED|95.0|-1.2|1.1||Two sided test with an a priori threshold of 0.05 for declaring statistical significance.|GEE||Estimate of the rate of survival to hospital discharge in Analyze Later arm minus rate in Analyze early arm.|Comparison of the rates of survival to hospital discharge in Analyze Early vs. Analyze Later arms using a generalized estimating equations model with an identity link, grouping on cluster.||1.1|-1.2|0.92
72348174|NCT00394706|144218084|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.0||||0.99|TWO_SIDED|95.0|-1.2|1.1|||t-test, 2 sided||Estimate of the rate of survival to hospital discharge in the active ITD arm minus rate in the Sham ITD arm.|Comparison of the rates of survival to hospital discharge in Active ITD and Sham treatment arms.||1.1|-1.2|0.99
72348175|NCT00394706|144218085|SUPERIORITY||Mean Difference (Final Values)|0.07|||||TWO_SIDED|95.0|-0.2|0.34|||||Mean MRS for Analyze Later minus mean MRS for Analyze Early (i.e. positive values favor Analyze Later).|Linear regression was used to assess associations between post-discharge measures and treatment group comparisons with adjustment for baseline characteristics. Site was adjusted for to accommodate clustering of patients within sites. All regression analyses used robust standard errors to accommodate non-constant variances.||0.34|-0.20|
72348176|NCT00394706|144218085|SUPERIORITY||Mean Difference (Final Values)|0.14|||||TWO_SIDED|95.0|-0.17|0.44|||||Mean MRS for Active ITD minus mean MRS for Sham ITD (i.e. positive values favor the active device).|Linear regression was used to assess associations between post-discharge measures and treatment group comparisons with adjustment for baseline characteristics. Site was adjusted for to accommodate clustering of patients within sites. All regression analyses used robust standard errors to accommodate non-constant variances.||0.44|-0.17|
72348177|NCT00394706|144218086|SUPERIORITY||Mean Difference (Final Values)|0.06|||||TWO_SIDED|95.0|-0.71|0.83|||||Mean ALFI-MMSE for Analyze Later minus mean ALFI-MMSE for Analyze Early (i.e. positive values favor Analyze Later).|Linear regression was used to assess associations between post-discharge measures and treatment group comparisons with adjustment for baseline characteristics. Site was adjusted for to accommodate clustering of patients within sites. All regression analyses used robust standard errors to accommodate non-constant variances.||0.83|-0.71|
72348178|NCT00394706|144218086|SUPERIORITY||Mean Difference (Final Values)|-0.66|||||TWO_SIDED|95.0|-1.61|0.28|||||Mean ALFI-MMSE for Active ITD minus mean ALFI-MMSE for Sham ITD (i.e. positive values favor the active device).|Linear regression was used to assess associations between post-discharge measures and treatment group comparisons with adjustment for baseline characteristics. Site was adjusted for to accommodate clustering of patients within sites. All regression analyses used robust standard errors to accommodate non-constant variances.||0.28|-1.61|
72348179|NCT00394706|144218087|SUPERIORITY||Mean Difference (Final Values)|0.0|||||TWO_SIDED|95.0|-0.06|0.05|||||Mean HUI for Analyze Later minus mean HUI for Analyze Early (i.e. positive values favor Analyze Later).|Linear regression was used to assess associations between post-discharge measures and treatment group comparisons with adjustment for baseline characteristics. Site was adjusted for to accommodate clustering of patients within sites. All regression analyses used robust standard errors to accommodate non-constant variances.||0.05|-0.06|
72429092|NCT01216293|144369089|SUPERIORITY_OR_OTHER_LEGACY||Difference|19.2|||||TWO_SIDED|95.0|7.0|30.2|||||Difference estimated using Hodges-Lehmann estimation, and corresponding 95% CIs calculated using Moses method.|||30.2|7.0|
72348180|NCT00394706|144218087|SUPERIORITY||Mean Difference (Final Values)|-0.02|||||TWO_SIDED|95.0|-0.08|0.05|||||Mean HUI for Active ITD minus mean HUI for Sham ITD (i.e. positive values favor the active device).|Linear regression was used to assess associations between post-discharge measures and treatment group comparisons with adjustment for baseline characteristics. Site was adjusted for to accommodate clustering of patients within sites. All regression analyses used robust standard errors to accommodate non-constant variances.||0.05|-0.08|
72348181|NCT03369249|144218088|SUPERIORITY||log ratio of rate ratios|0.15|STANDARD_ERROR_OF_MEAN|0.31||0.635|TWO_SIDED|95.0|-0.46|0.75||A priori threshold for statistical significance was \<0.05|generalized estimating equations||Standard error of the Beta regression coefficient.|||0.75|-0.46|0.635
72429093|NCT01216293|144369089|SUPERIORITY_OR_OTHER_LEGACY||Difference|18.2|||||TWO_SIDED|95.0|6.7|30.4|||||Difference estimated using Hodges-Lehmann estimation, and corresponding 95% CIs calculated using Moses method.|||30.4|6.7|
72429094|NCT01216293|144369090|SUPERIORITY_OR_OTHER_LEGACY||Difference|27.366|||||TWO_SIDED|95.0|12.749|42.957|||||Difference estimated using Hodges-Lehmann estimation, and corresponding 95% CIs calculated using Moses method.|||42.957|12.749|
72348182|NCT05292131|144218147|EQUIVALENCE|Bioequivalence (BE) was concluded if the 90% CIs for the ratio of the respective comparison are fully included in the acceptance range from 0.8 to 1.25 for AUC.|Geometric Mean Ratio (percentage [%])|97.5|||||TWO_SIDED|90.0|90.2|105.4||||||||105.40|90.20|
72348183|NCT05292131|144218148|EQUIVALENCE|BE was concluded if the 90% CIs for the ratio of the respective comparison are fully included in the acceptance range from 0.8 to 1.25 for AUC0-t.|Geometric Mean Ratio (%)|97.05|||||TWO_SIDED|90.0|90.1|104.55||||||||104.55|90.10|
72348184|NCT05292131|144218149|EQUIVALENCE|BE was concluded if the 90% CIs for the ratio of the respective comparison are fully included in the acceptance range from 0.8 to 1.25 for Cmax.|Geometric Mean Ratio (%)|96.21|||||TWO_SIDED|90.0|88.6|104.47||||||||104.47|88.60|
72348185|NCT05292131|144218152|EQUIVALENCE|BE was concluded if the 90% CIs for the ratio of the respective comparison are fully included in the acceptance range from 0.8 to 1.25 for t½.|Geometric Mean Ratio (%)|101.13|||||TWO_SIDED|90.0|94.18|108.59||||||||108.59|94.18|
72348186|NCT05292131|144218153|EQUIVALENCE|The point estimate and the 90% CI for the median treatment differences for tmax was computed according to the Hodges-Lehmann's method.|Hodges-Lehman Estimate|0.4897|||||TWO_SIDED|90.0|-0.0073|0.9567||||||||0.9567|-0.0073|
72348187|NCT01053988|144218188|SUPERIORITY_OR_OTHER||Least squares mean difference|0.053||||0.04|TWO_SIDED|95.0|0.003|0.104||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).||||0.104|0.003|0.040
72348188|NCT01053988|144218188|SUPERIORITY_OR_OTHER||Least squares mean difference|0.103|||<|0.001|TWO_SIDED|95.0|0.052|0.153|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).||||0.153|0.052|<0.001
72348189|NCT01053988|144218188|SUPERIORITY_OR_OTHER||Least squares mean difference|0.192|||<|0.001|TWO_SIDED|95.0|0.141|0.243||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).||||0.243|0.141|<0.001
72348190|NCT01053988|144218188|SUPERIORITY_OR_OTHER||Least squares mean difference|0.173|||<|0.001|TWO_SIDED|95.0|0.123|0.224|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).||||0.224|0.123|<0.001
72348191|NCT01053988|144218188|SUPERIORITY_OR_OTHER||Least squares mean difference|0.12|||<|0.001|TWO_SIDED|95.0|0.07|0.17|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).||||0.170|0.070|<0.001
72348192|NCT01053988|144218188|SUPERIORITY_OR_OTHER||Least squares mean difference|0.09|||<|0.001|TWO_SIDED|95.0|0.039|0.14||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).||||0.140|0.039|<0.001
72348193|NCT01053988|144218188|SUPERIORITY_OR_OTHER||Least squares mean difference|0.071||||0.006|TWO_SIDED|95.0|0.021|0.121||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).||||0.121|0.021|0.006
72348194|NCT01053988|144218189|SUPERIORITY_OR_OTHER||Least squares mean difference|0.033||||0.241|TWO_SIDED|95.0|-0.022|0.088|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).||||0.088|-0.022|0.241
72348195|NCT01053988|144218189|SUPERIORITY_OR_OTHER||Least squares mean difference|0.067||||0.017|TWO_SIDED|95.0|0.012|0.121|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).||||0.121|0.012|0.017
72348196|NCT01053988|144218189|SUPERIORITY_OR_OTHER||Least squares mean difference|0.129|||<|0.001|TWO_SIDED|95.0|0.074|0.184||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).||||0.184|0.074|<0.001
72348197|NCT01053988|144218189|SUPERIORITY_OR_OTHER||Least squares mean difference|0.115|||<|0.001|TWO_SIDED|95.0|0.06|0.169|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).||||0.169|0.060|<0.001
72348198|NCT01053988|144218189|SUPERIORITY_OR_OTHER||Least squares mean difference|0.082||||0.003|TWO_SIDED|95.0|0.028|0.136||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).||||0.136|0.028|0.003
72348199|NCT01053988|144218189|SUPERIORITY_OR_OTHER||Least squares mean difference|0.062||||0.025|TWO_SIDED|95.0|0.008|0.117||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).||||0.117|0.008|0.025
72348200|NCT01053988|144218189|SUPERIORITY_OR_OTHER||Least squares mean difference|0.048||||0.082|TWO_SIDED|95.0|-0.006|0.102|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).||||0.102|-0.006|0.082
72348201|NCT05723263|144218230|OTHER||Proportional difference|91.0|||<|0.01|TWO_SIDED|95.0|90.2|91.8||The threshold for statistical significance was p\<0.05.|Generalized Estimating Equations|||It was calculated that 12 clinic sites with 1200 participants randomized in a 1:1:1 ratio between the three arms, would have at least 90% power to detect a 10% difference in the proportion of test uptake between the pay-it-forward and control group participants, using a two-sided, two-sample t-test (α=0.05), assuming a 0.25\~0.31 cluster coefficient of variation, \<5% lost-to-follow-up rate, and an intra-class correlation of 0.016.||91.8|90.2|<0.01
72348202|NCT05723263|144218231|OTHER||||||<|0.001|||||||Chi-squared|||||||<0.001
72348203|NCT05723263|144218232|OTHER|||||||0.0059|||||||Chi-squared|||||||0.0059
72348204|NCT05723263|144218233|OTHER||||||<|0.001|||||||Chi-squared|||||||<0.001
72348205|NCT05723263|144218235|OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
72348206|NCT05723263|144218236|OTHER|||||||0.007|||||||t-test, 2 sided|||||||0.007
72348207|NCT05723263|144218237|OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
72348208|NCT05723263|144218238|OTHER|||||||0.727|||||||t-test, 2 sided|||||||0.727
72348209|NCT03375489|144218245|EQUIVALENCE|Equivalence was established for patient-reported quality of life if the 90% confidence interval for the estimated difference in means was within the margin of ±4 points on the Functional Assessment of Cancer Therapy - Lung Questionnaire.|Mean Difference (Final Values)|2.0||||0.04|TWO_SIDED|90.0|0.1|3.9||The a priori threshold for statistical significance was p\<0.05.|Regression, Linear|||The difference in week-24 means between groups was estimated using a linear regression model with a main effect for group assignment and controlling for baseline Functional Assessment of Cancer Therapy - Lung Questionnaire scores.||3.9|0.1|0.04
72370172|NCT00838513|144250676|SUPERIORITY_OR_OTHER||LS mean change from baseline|-3.68||||0.7307|TWO_SIDED|95.0|-25.15|17.79|||ANOVA|Change from baseline were analyzed using a repeated measurement ANOVA model with time and baseline as fixed effects and subject as a random effect.||All analyses were based on the pooled data from the two protocols: C08-003A (adult) and C08-003B (adolescent), a similar protocol, for patients \<18 years with aHUS.||17.79|-25.15|0.7307
72348210|NCT03375489|144218246|EQUIVALENCE|Equivalence was established for patient-reported communication with their clinicians about their end-of-life care preferences if the 90% confidence interval for the estimated difference in proportions was within the margin of ±8%.|Estimated Difference in Proportions|3.1||||0.26|TWO_SIDED|90.0|-1.8|8.1||Bonferroni-adjusted p-value|binomial generalized estimating equation|||The difference between groups in the proportions of patients reporting that they communicated with their clinicians about their end-of-life care preferences was estimated using a binomial generalized estimating equation model with robust standard errors, the identity link function, and a main effect for group assignment.||8.1|-1.8|0.26
72348211|NCT03375489|144218247|EQUIVALENCE|Equivalence was established for patient length of stay in hospice if the 90% confidence interval for the estimated difference in mean days was within the margin of ±6 days.|Mean Difference (Final Values)|0.2||||0.46|TWO_SIDED|90.0|-7.0|7.4||Bonferroni-adjusted p-value|Regression, Linear|||The difference in mean length of stay in hospice between groups was estimated using a linear regression model with a main effect for group assignment.||7.4|-7.0|0.46
72348212|NCT03375489|144218248|SUPERIORITY||Difference in estimated proportions|-13.0|||<|0.001|TWO_SIDED|95.0|-17.6|-8.6||Bonferroni-adjusted p-value|binomial generalized estimating equation|||The proportion of palliative care visits with caregiver participation was compared using a binomial generalized estimating equation model with robust standard errors, the identity link function, and a main effect for group assignment.||-8.6|-17.6|<0.001
72348213|NCT03375489|144218249|SUPERIORITY||Mean Difference (Final Values)|0.3|||>|0.99|TWO_SIDED|95.0|-1.0|1.7||Bonferroni-adjusted p-value|Regression, Linear|||The difference in week-24 means between groups was estimated using a linear regression model with a main effect for group assignment.||1.7|-1.0|>0.99
72348214|NCT03375489|144218250|SUPERIORITY||Mean Difference (Final Values)|0.4|||>|0.99|TWO_SIDED|95.0|-1.5|2.3||Bonferroni-adjusted p-value|Regression, Linear|||The difference in week-24 means between groups was estimated using a linear regression model with a main effect for group assignment.||2.3|-1.5|>0.99
72348215|NCT00145574|144218270|SUPERIORITY_OR_OTHER|||||||0.1122|||||||ANCOVA|||The primary null hypotheses were tested sequentially in the following order: 1) no difference between the high-dose colesevelam HCl and placebo for percent change in LDL-C from study baseline to Week 8 endpoint with the last observation carried forward (LOCF) and 2) no difference between the low-dose colesevelam HCl and placebo for percent change in LDL-C from study baseline to Week 8 endpoint with LOCF. The hypotheses were tested at a 2-sided significance level of 5%.||||0.1122
72348216|NCT00145574|144218270|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||||||<0.0001
72348217|NCT00145574|144218271|SUPERIORITY_OR_OTHER|||||||0.526||95.0|||||ANCOVA|||||||0.5260
72348218|NCT00145574|144218271|SUPERIORITY_OR_OTHER|||||||0.0085||95.0|||||ANCOVA|||||||0.0085
72348219|NCT00145574|144218272|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||||||<0.0001
72348220|NCT00145574|144218272|SUPERIORITY_OR_OTHER|||||||0.0008||95.0|||||ANCOVA|||||||0.0008
72348221|NCT00145574|144218273|SUPERIORITY_OR_OTHER|||||||0.0155||95.0|||||ANCOVA|||||||0.0155
72348222|NCT00145574|144218273|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||||||<0.0001
72348223|NCT00145574|144218274|SUPERIORITY_OR_OTHER|||||||0.3482||95.0|||||ANCOVA|||||||0.3482
72348224|NCT00145574|144218274|SUPERIORITY_OR_OTHER|||||||0.0006||95.0|||||ANCOVA|||||||0.0006
72429095|NCT01216293|144369090|SUPERIORITY_OR_OTHER_LEGACY||Difference|22.025|||||TWO_SIDED|95.0|8.357|35.714|||||Difference estimated using Hodges-Lehmann estimation, and corresponding 95% CIs calculated using Moses method.|||35.714|8.357|
72348225|NCT00145574|144218275|SUPERIORITY_OR_OTHER|||||||0.0002||95.0|||||ANCOVA|||||||0.0002
72348226|NCT00145574|144218275|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||||||<0.0001
72348227|NCT00145574|144218276|SUPERIORITY_OR_OTHER|||||||0.7433||95.0|||||ANCOVA|||||||0.7433
72348228|NCT00145574|144218276|SUPERIORITY_OR_OTHER|||||||0.0003||95.0|||||ANCOVA|||||||0.0003
72348229|NCT00112125|144218313|NON_INFERIORITY|The primary safety analysis was a test of the non-inferiority of CCM therapy compared to OMT with respect to the proportion of subjects experiencing death or hospitalization within 50 weeks using the Blackwelder non-inferiority test12 with a prespecified non-inferiority margin of 0.125.||||||0.31|||||||Fisher Exact|||||||0.31
72348230|NCT00112125|144218314|NON_INFERIORITY|The noninferiority margin was selected to be 12.5% and α was set at .05, which resulted in a sample size of 198 subjects per group. A percentage of subjects (∼7%) were expected to be lost to followup, so that a total sample size of 428 subjects (214 per group) was selected.||||||0.125|||||||Blackwelder|||||||0.125
72348231|NCT03543137|144218319|EQUIVALENCE|Bioequivalence was determined if the 90% CIs of the GMRs for AUC0-t fell completely within the 0.80 - 1.25 range.|Geometric mean ratio|0.95|||||TWO_SIDED|90.0|0.88|1.02|||||GMR= (Prototype mini Lozenge/ Nicorette mini Lozenge)|||1.02|0.88|
72348232|NCT03543137|144218320|EQUIVALENCE|Bioequivalence was determined if the 90% CIs of the GMRs for AUC0-inf fell completely within the range.|Geometric Mean Ratio|0.94|||||TWO_SIDED|90.0|0.88|1.01|||||GMR = (Prototype mini Lozenge/Nicorette mini Lozenge)|||1.01|0.88|
72348233|NCT03543137|144218325|EQUIVALENCE|Bioequivalence was determined if the 90% CIs of the GMRs for Cmax fell completely within the range.|Geometric Mean Ratio|0.97|||||TWO_SIDED|90.0|0.9|1.04|||||GMR = (Prototype mini Lozenge/Nicorette mini Lozenge)|||1.04|0.90|
72348234|NCT04230213|144218331|EQUIVALENCE|Equivalence was to be determined if the 90% confidence interval of the geometric mean ratio falls within the 80% to 125% range.|Geometric mean ratio (percentage)|102.56|||||TWO_SIDED|90.0|89.78|117.17|||||Analysis was performed using analysis of variance (ANOVA) model.|||117.17|89.78|
72348235|NCT04230213|144218332|EQUIVALENCE|Equivalence was to be determined if the 90% confidence interval of the geometric mean ratio falls within the 80% to 125% range.|Geometric mean ratio (Percentage)|105.31|||||TWO_SIDED|90.0|89.16|124.39|||||Analysis was performed using ANOVA model.|||124.39|89.16|
72348236|NCT02178696|144218362|OTHER||Mean Difference (Net)|0.12|STANDARD_DEVIATION|0.31|<|0.001|TWO_SIDED|95.0|0.016|0.23||A p\<0.001 was established for regions a priori hypothesized (e.g. nucleus accumbens).|t-test, 2 sided|||||0.23|0.016|<0.001
72348237|NCT03857542|144218392|SUPERIORITY||Percentage Difference|15.2|||<|0.0001|TWO_SIDED|95.0|7.7|22.7||P-value was adjusted for multiplicity control.|Chi-squared||Analysis was done using Chi-square test. The 95% confidence intervals for the proportion differences were calculated based on the normal approximation based on pooled variance without continuity correction.|||22.7|7.7|<.0001
72429096|NCT01216293|144369091|SUPERIORITY_OR_OTHER_LEGACY||Difference|20.1|||||TWO_SIDED|95.0|4.0|34.4|||||Difference estimated using Hodges-Lehmann estimation, and corresponding 95% CIs calculated using Moses method.|||34.4|4.0|
72348238|NCT03857542|144218393|SUPERIORITY||Percentage Difference|6.5||||0.0548|TWO_SIDED|95.0|-0.1|13.1||P-value was adjusted for multiplicity control.|Chi-squared||Analysis was done using Chi-square test. The 95% confidence intervals for the proportion difference was calculated based on the normal approximation based on pooled variance without continuity correction.|||13.1|-0.1|0.0548
72348239|NCT03857542|144218394|SUPERIORITY||Percentage Difference|5.9||||0.0693|TWO_SIDED|95.0|-0.5|12.2||P-value was adjusted for multiplicity control.|Chi-squared||Analysis was done using Chi-square test. The 95% confidence intervals for the proportion difference was calculated based on the normal approximation based on pooled variance without continuity correction.|||12.2|-0.5|0.0693
72348240|NCT03857542|144218395|SUPERIORITY||Least Squares (LS) Mean Difference|4.1|STANDARD_ERROR_OF_MEAN|0.59|<|0.0001|TWO_SIDED|95.0|2.9|5.2||MMRM with study intervention group, visit, visit by study intervention group interaction, age group, Baseline binocular DCNVA severity, iris color, emmetrope/non-emmetrope, Baseline value; Baseline value by visit interaction as fixed effects.|MMRM|P-value was adjusted for multiplicity control.||||5.2|2.9|<.0001
72348241|NCT03857542|144218396|SUPERIORITY||Percentage Difference|9.9||||0.0141|TWO_SIDED|95.0|3.5|16.3||P-value was adjusted for multiplicity control.|Chi-squared||Analysis was done using chi-square test. The 95% confidence intervals was calculated based on normal approximation based on pooled variance without continuity correction.|||16.3|3.5|0.0141
72348242|NCT03857542|144218397|SUPERIORITY||LS Mean Difference|0.8|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|0.5|1.0||Analysis of covariance (ANCOVA) with study intervention group, age group, Baseline binocular DCNVA severity, iris color (brown/non-brown), emmetrope/non-emmetrope, and Baseline domain score as fixed effects.|ANCOVA|P-value was adjusted for multiplicity control||||1.0|0.5|<.0001
72348243|NCT03857542|144218398|SUPERIORITY||LS Mean Difference|3.4|STANDARD_ERROR_OF_MEAN|0.52|<|0.0001|TWO_SIDED|95.0|2.4|4.4||MMRM with study intervention group, visit, visit by study intervention group interaction, age group, Baseline binocular DCNVA severity, iris color, emmetrope/non-emmetrope, Baseline value, and Baseline value by visit interaction as fixed effects.|MMRM|P-value was adjusted for multiplicity control.||||4.4|2.4|<.0001
72348244|NCT03857542|144218399|SUPERIORITY||Percentage Difference|3.8||||0.22|TWO_SIDED|95.0|-2.3|10.0||P-value was adjusted for multiplicity control.|Chi-squared||Analysis was done using chi-square test. The 95% confidence intervals for the proportion differences were calculated based on the normal approximation based on pooled variance without continuity correction.|||10.0|-2.3|0.2200
72348245|NCT03857542|144218400|SUPERIORITY||LS Mean Difference|2.6|STANDARD_ERROR_OF_MEAN|0.55|<|0.0001|TWO_SIDED|95.0|1.5|3.7||MMRM with study intervention group, visit, visit by study intervention group interaction, age group, Baseline binocular DCNVA severity, iris color, emmetrope/non-emmetrope, Baseline value, and Baseline value by visit interaction as fixed effects.|MMRM|P-value was adjusted for multiplicity control.||||3.7|1.5|<.0001
72348246|NCT03857542|144218401|SUPERIORITY||Percentage Difference|12.4||||0.0141|TWO_SIDED|95.0|5.2|19.5||P-value was adjusted for multiplicity control.|Chi-squared||Analysis was done using chi-square test. The 95% confidence intervals was calculated based on normal approximation based on pooled variance without continuity correction.|||19.5|5.2|0.0141
72348247|NCT03857542|144218402|SUPERIORITY||LS Mean Difference|0.7|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001|TWO_SIDED|95.0|0.5|1.0||ANCOVA with study intervention group, age group, Baseline binocular DCNVA severity, iris color (brown/non-brown), emmetrope/non-emmetrope, and Baseline domain score as fixed effects.|ANCOVA|P-value was adjusted for multiplicity control.||||1.0|0.5|<.0001
72348248|NCT03857542|144218403|SUPERIORITY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.08||0.0002|TWO_SIDED|95.0|-0.5|-0.2||ANCOVA with study intervention group, age group, Baseline binocular DCNVA severity, iris color (brown/non-brown), emmetrope/non-emmetrope, and Baseline domain score as fixed effects.|ANCOVA|P-value was adjusted for multiplicity control.||||-0.2|-0.5|0.0002
72348249|NCT03857542|144218404|SUPERIORITY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.07||0.0002|TWO_SIDED|95.0|-0.4|-0.2||ANCOVA with study intervention group, age group, Baseline binocular DCNVA severity, iris color (brown/non-brown), emmetrope/non-emmetrope, and Baseline domain score as fixed effects.|ANCOVA|P-value was adjusted for multiplicity control.||||-0.2|-0.4|0.0002
72348250|NCT00571974|144218421|SUPERIORITY_OR_OTHER|||||||0.0001||95.0||||One-sided exact binomial test to compare the observed response rate to the 20% rate envisioned under the original null hypothesis.|One-sided exact binomial test|Because all but one subject responded to treatment, the Fisher's exact test was addedd.||The Simon two-stage minimax design with 9 subjects in the first stage and 8 subjects in the second stage, yielding 17 subjects overall. This design's early termination rule was ≤3/9 responses in the first stage, and its success criterion was ≥7/17 responses overall. This design had 80% power at 5% alpha to distinguish an efficacious 50% response rate from a null-hypothesis 20% response rate.||||0.0001
72348251|NCT04255862|144218427|EQUIVALENCE|Bioequivalence (BE) was concluded if the 90% CIs for the ratio of the respective comparison are fully included in the acceptance range from 80 to 125 for AUC.|Geometric Mean Ratio|103.4|||||TWO_SIDED|90.0|86.4|123.8||||||||123.8|86.4|
72429097|NCT01216293|144369091|SUPERIORITY_OR_OTHER_LEGACY||Difference|11.6|||||TWO_SIDED|95.0|-2.7|28.3|||||Difference estimated using Hodges-Lehmann estimation, and corresponding 95% CIs calculated using Moses method.|||28.3|-2.7|
72348252|NCT04255862|144218427|EQUIVALENCE|BE was concluded if the 90% CIs for the ratio of the respective comparison are fully included in the acceptance range from 80 to 125 for AUC.|Geometric Mean Ratio|115.0|||||TWO_SIDED|90.0|97.9|135.0||||||||135.0|97.9|
72348253|NCT04255862|144218428|EQUIVALENCE|BE was concluded if the 90% CIs for the ratio of the respective comparison are fully included in the acceptance range from 80 to 125 for AUC0-t.|Geometric Mean Ratio|102.8|||||TWO_SIDED|90.0|87.0|121.5||||||||121.5|87.0|
72348254|NCT04255862|144218428|EQUIVALENCE|BE was concluded if the 90% CIs for the ratio of the respective comparison are fully included in the acceptance range from 80 to 125 for AUC0-t.|Geometric Mean Ratio|113.4|||||TWO_SIDED|90.0|97.4|131.9||||||||131.9|97.4|
72348255|NCT04255862|144218429|EQUIVALENCE|BE was concluded if the 90% CIs for the ratio of the respective comparison are fully included in the acceptance range from 80 to 125 for Cmax.|Geometric Mean Ratio|104.0|||||TWO_SIDED|90.0|90.3|119.7||||||||119.7|90.3|
72348256|NCT04255862|144218429|EQUIVALENCE|BE was concluded if the 90% CIs for the ratio of the respective comparison are fully included in the acceptance range from 80 to 125 for Cmax.|Geometric Mean Ratio|114.3|||||TWO_SIDED|90.0|99.5|131.4||||||||131.4|99.5|
72348257|NCT00799266|144218441|SUPERIORITY|Difference in least squares (LS) = LS mean for the zoledronic acid group-LS mean for the placebo group.|Difference in LS mean|0.414||||0.0392|TWO_SIDED|95.0|0.022|0.806|||ANCOVA|||Lumbar Spine BMD Z-score at Month 12||0.806|0.022|0.0392
72348258|NCT00799266|144218442|SUPERIORITY|Difference in least squares (LS) = LS mean for the zoledronic acid group-LS mean for the placebo group.|Difference in LS mean|0.29||||0.1322|TWO_SIDED|95.0|-0.094|0.673|||ANCOVA|||Lumbar Spine BMD Z-score at Month 6||0.673|-0.094|0.1322
72348259|NCT00799266|144218443|OTHER|Difference in least squares (LS) = LS mean for the zoledronic acid group-LS mean for the placebo group.|Difference in LS mean|1.979||||0.0409|TWO_SIDED|95.0|0.089|3.869|||ANCOVA|||Lumbar Spine BMC at Month 6||3.869|0.089|0.0409
72348260|NCT00799266|144218443|OTHER|Difference in least squares (LS) = LS mean for the zoledronic acid group-LS mean for the placebo group.|Difference in LS mean|2.155||||0.234|TWO_SIDED|95.0|-1.488|5.798|||ANCOVA|||Lumbar Spine BMC at Month 12||5.798|-1.488|0.2340
72348261|NCT00799266|144218444|OTHER|Difference in least squares (LS) = LS mean for the zoledronic acid group-LS mean for the placebo group.|Difference in LS mean|34.058||||0.3827|TWO_SIDED|95.0|-45.385|113.502|||ANCOVA|||Total Body BMC at Month 6||113.502|-45.385|0.3827
72348262|NCT00799266|144218444|OTHER|Difference in least squares (LS) = LS mean for the zoledronic acid group-LS mean for the placebo group.|Difference in LS mean|80.741||||0.2634|TWO_SIDED|95.0|-65.602|227.084|||ANCOVA|||Total Body BMC at Month 12||227.084|-65.602|0.2634
72348263|NCT00799266|144218445|OTHER|Difference in least squares (LS) = LS mean for the zoledronic acid group-LS mean for the placebo group.|Difference in LS mean|-211.782||||0.0631|TWO_SIDED|95.0|-363.765|-59.8|||ANCOVA|||Serum P1NP at Month 6||-59.800|-363.765|0.0631
72348264|NCT00799266|144218445|OTHER|Difference in least squares (LS) = LS mean for the zoledronic acid group-LS mean for the placebo group.|Difference in LS mean|-381.132||||0.0049|TWO_SIDED|95.0|-565.416|-196.848|||ANCOVA|||Serum P1NP at Month 12||-196.848|-565.416|0.0049
72348265|NCT00799266|144218446|OTHER|Difference in least squares (LS) = LS mean for the zoledronic acid group-LS mean for the placebo group.|Difference in LS mean|-11.223||||0.2129|TWO_SIDED|95.0|-22.595|0.149|||ANCOVA|||Serum BSAP at Month 6||0.149|-22.595|0.2129
72348266|NCT00799266|144218446|OTHER|Difference in least squares (LS) = LS mean for the zoledronic acid group-LS mean for the placebo group.|Difference in LS mean|-20.435||||0.0215|TWO_SIDED|95.0|-33.96|-6.909|||ANCOVA|||Serum BSAP at Month 12||-6.909|-33.960|0.0215
72348267|NCT00799266|144218447|OTHER|Difference in least squares (LS) = LS mean for the zoledronic acid group-LS mean for the placebo group.|Difference in LS mean|-20.938||||0.0254|TWO_SIDED|95.0|-33.766|-8.11|||ANCOVA|||Serum NTX at Month 6||-8.110|-33.766|0.0254
72348268|NCT00799266|144218447|OTHER|Difference in least squares (LS) = LS mean for the zoledronic acid group-LS mean for the placebo group.|Difference in LS mean|-27.574||||0.0002|TWO_SIDED|95.0|-39.037|-16.111|||ANCOVA|||Serum NTX at Month 12||-16.111|-39.037|0.0002
72348269|NCT00799266|144218448|OTHER|Difference in least squares (LS) = LS mean for the zoledronic acid group-LS mean for the placebo group.|Difference in LS mean|-1.874||||0.2178|TWO_SIDED|95.0|-3.931|0.182|||ANCOVA|||Serum TRAP-5b at Month 6||0.182|-3.931|0.2178
72348270|NCT00799266|144218448|OTHER|Difference in least squares (LS) = LS mean for the zoledronic acid group-LS mean for the placebo group.|Difference in LS mean|-1.837||||0.184|TWO_SIDED|95.0|-4.103|0.429|||ANCOVA|||Serum TRAP-5b at Month 12||0.429|-4.103|0.1840
72348271|NCT00799266|144218449|OTHER|The number and percentage of patients with new vertebral fractures at Month 12 were presented by treatment group and between-treatment differences were evaluated using Fisher's exact test.||||||0.2258|||||||Fisher Exact|||New vertebral fractures at Month 12||||0.2258
72348272|NCT00799266|144218450|OTHER|Difference in least squares (LS) = LS mean for the zoledronic acid group-LS mean for the placebo group.|Difference in LS mean|-0.018||||0.318|TWO_SIDED|95.0|-0.055|0.019|||ANCOVA|||Vertebral morphometry at Month 12||0.019|-0.055|0.3180
72348273|NCT00799266|144218451|OTHER|Presented by treatment group and evaluated using a logistic regression model with treatment, pooled centers, underlying condition treated with glucocorticoids and baseline pain score as explanatory variables.|Odds Ratio (OR)|0.45||||0.5226|TWO_SIDED|95.0|0.04|5.2|||Regression, Logistic|||Reduction in Pain at Month 3||5.20|0.04|0.5226
72348274|NCT00799266|144218451|OTHER|Presented by treatment group and evaluated using a logistic regression model with treatment, pooled centers, underlying condition treated with glucocorticoids and baseline pain score as explanatory variables.|Odds Ratio (OR)|999.99||||0.522|TWO_SIDED|95.0|0.01|999.99||\>999.99 (\<0.01, \>999.99)|Regression, Logistic|||Reduction in Pain at Month 6||999.99|0.01|0.5220
72348275|NCT00799266|144218451|OTHER|Presented by treatment group and evaluated using a logistic regression model with treatment, pooled centers, underlying condition treated with glucocorticoids and baseline pain score as explanatory variables.|Odds Ratio (OR)|0.52||||0.6019|TWO_SIDED|95.0|0.04|6.22|||Regression, Logistic|||Reduction in Pain at Month 9||6.22|0.04|0.6019
72348276|NCT00799266|144218451|OTHER|Presented by treatment group and evaluated using a logistic regression model with treatment, pooled centers, underlying condition treated with glucocorticoids and baseline pain score as explanatory variables.|Odds Ratio (OR)|0.45||||0.9652|TWO_SIDED|0.9652|0.01|999.99||0.45 (\<0.01, \>999.99)|Regression, Logistic|||Reduction in Pain at Month 12||999.99|0.01|0.9652
72348277|NCT00799266|144218452|OTHER|Difference in least squares (LS) = LS mean for the zoledronic acid group-LS mean for the placebo group.|Difference in LS mean|-0.04||||0.5165|TWO_SIDED|95.0|-0.17|0.09|||ANCOVA|||2nd metacarpal cortical width at Month 12||0.09|-0.17|0.5165
72348278|NCT01724866|144218482|NON_INFERIORITY|Non-inferiority was demonstrated if the upper CI was \< 1 day.|Mean Difference (Final Values)|0.72||||0.296|TWO_SIDED|95.0|0.19|1.27|||Bootstrap method|||A 2-sided 95% confidence interval (CI) for the difference in mean DSN between any 2 arms was calculated. Non-inferiority p-value was calculated as two times the proportion of treatment difference greater than 1 in the resampling.||1.27|0.19|0.296
72348279|NCT01724866|144218482|NON_INFERIORITY|Non-inferiority was demonstrated if the upper CI was \< 1 day.|Mean Difference (Final Values)|0.14||||0.002|TWO_SIDED|95.0|-0.28|0.64|||Bootstrap method|||A 2-sided 95% CI for the difference in mean DSN between any 2 arms was calculated. Non-inferiority p-value was calculated as two times the proportion of treatment difference greater than 1 in the resampling.||0.64|-0.28|0.002
72348280|NCT01724866|144218482|NON_INFERIORITY|Non-inferiority was demonstrated if the upper CI was \< 1 day.|Mean Difference (Final Values)|-0.28|||<|0.001|TWO_SIDED|95.0|-0.56|-0.06|||Bootstrap method|||A 2-sided 95% CI for the difference in mean DSN between any 2 arms was calculated. Non-inferiority p-values was calculated as two times the proportion of treatment difference greater than 1 in the resampling.||-0.06|-0.56|<0.001
72348281|NCT01724866|144218483|NON_INFERIORITY|Non-inferiority was demonstrated if the upper CI was \< 1 day.|Mean Difference (Final Values)|0.38||||0.001|TWO_SIDED|95.0|0.06|0.74|||Bootstrap method|||A 2-sided 95% CI for the difference in mean DSN between any 2 arms was calculated. Non-inferiority p-value was calculated as two times the proportion of treatment difference greater than 1 in the resampling.||0.74|0.06|0.001
72348282|NCT01724866|144218483|NON_INFERIORITY|Non-inferiority was demonstrated if the upper CI was \< 1 day.|Mean Difference (Final Values)|0.04|||<|0.001|TWO_SIDED|95.0|-0.16|0.24|||Bootstrap method|||A 2-sided 95% CI for the difference in mean DSN between any 2 arms was calculated. Non-inferiority p-value was calculated as two times the proportion of treatment difference greater than 1 in the resampling.||0.24|-0.16|<0.001
72348283|NCT01724866|144218483|NON_INFERIORITY|Non-inferiority was demonstrated if the upper CI was \< 1 day.|Mean Difference (Final Values)|-0.05|||<|0.001|TWO_SIDED|95.0|-0.19|0.06|||Bootstrap method|||A 2-sided 95% CI for the difference in mean DSN between any 2 arms was calculated. Non-inferiority p-value was calculated as two times the proportion of treatment difference greater than 1 in the resampling.||0.06|-0.19|<0.001
72348284|NCT01724866|144218484|NON_INFERIORITY|Non-inferiority was demonstrated if the upper CI was \< 1 day.|Mean Difference (Final Values)|0.31||||0.002|TWO_SIDED|95.0|-0.07|0.72|||Bootstrap method|||A 2-sided 95% CI for the difference in mean DSN between any 2 arms was calculated. Non-inferiority p-value was calculated as two times the proportion of treatment difference greater than 1 in the resampling.||0.72|-0.07|0.002
72348285|NCT01724866|144218484|NON_INFERIORITY|Non-inferiority was demonstrated if the upper CI was \< 1 day.|Mean Difference (Final Values)|0.02|||<|0.001|TWO_SIDED|95.0|-0.27|0.3|||Bootstrap method|||A 2-sided 95% CI for the difference in mean DSN between any 2 arms was calculated. Non-inferiority p-value was calculated as two times the proportion of treatment difference greater than 1 in the resampling.||0.30|-0.27|<0.001
72348286|NCT01724866|144218484|NON_INFERIORITY|Non-inferiority was demonstrated if the upper CI was \< 1 day.|Mean Difference (Final Values)|0.01|||<|0.001|TWO_SIDED|95.0|-0.27|0.28|||Bootstrap method|||A 2-sided 95% CI for the difference in mean DSN between any 2 arms was calculated. Non-inferiority p-value was calculated as two times the proportion of treatment difference greater than 1 in the resampling.||0.28|-0.27|<0.001
72348287|NCT01724866|144218485|NON_INFERIORITY|Non-inferiority was demonstrated if the upper CI was \< 1 day.|Mean Difference (Final Values)|0.94||||0.781|TWO_SIDED|95.0|-0.01|2.47|||Bootstrap method|||A 2-sided 95% CI for the difference in mean DSN between any 2 arms was calculated. Non-inferiority p-value was calculated as two times the proportion of treatment difference greater than 1 in the resampling.||2.47|-0.01|0.781
72348288|NCT01724866|144218485|NON_INFERIORITY|Non-inferiority was demonstrated if the upper CI was \< 1 day.|Mean Difference (Final Values)|0.07|||<|0.001|TWO_SIDED|95.0|-0.17|0.38|||Bootstrap method|||A 2-sided 95% CI for the difference in mean DSN between any 2 arms was calculated. Non-inferiority p-value was calculated as two times the proportion of treatment difference greater than 1 in the resampling.||0.38|-0.17|<0.001
72348289|NCT01724866|144218485|NON_INFERIORITY|Non-inferiority was demonstrated if the upper CI was \< 1 day.|Mean Difference (Final Values)|-0.02|||<|0.001|TWO_SIDED|95.0|-0.23|0.22|||Bootstrap method|||A 2-sided 95% CI for the difference in mean DSN between any 2 arms was calculated. Non-inferiority p-value was calculated as two times the proportion of treatment difference greater than 1 in the resampling.||0.22|-0.23|<0.001
72348290|NCT01724866|144218486|SUPERIORITY||Hazard Ratio (HR)|1.4||||0.002|TWO_SIDED|95.0|1.1|1.8|||Log Rank|||A Cox proportional hazards model was used to estimate the hazard ratio and its two-sided 95% CI.||1.8|1.1|0.002
72348291|NCT01724866|144218486|SUPERIORITY||Hazard Ratio (HR)|0.9||||0.711|TWO_SIDED|95.0|0.6|1.4|||Log Rank|||A Cox proportional hazards model was used to estimate the hazard ratio and its two-sided 95% CI.||1.4|0.6|0.711
72348292|NCT01724866|144218486|SUPERIORITY||Hazard Ratio (HR)|0.3||||0.028|TWO_SIDED|95.0|0.1|0.9|||Log Rank|||A Cox proportional hazards model was used to estimate the hazard ratio and its two-sided 95% CI.||0.9|0.1|0.028
72429098|NCT01216293|144369092|SUPERIORITY_OR_OTHER_LEGACY||Difference|6.83|||||TWO_SIDED|95.0|0.4|12.78|||||Difference estimated using Hodges-Lehmann estimation, and corresponding 95% CIs calculated using Moses method.|||12.78|0.40|
72429099|NCT01216293|144369092|SUPERIORITY_OR_OTHER_LEGACY||Difference|7.23|||||TWO_SIDED|95.0|0.59|12.86|||||Difference estimated using Hodges-Lehmann estimation, and corresponding 95% CIs calculated using Moses method.|||12.86|0.59|
72348293|NCT01724866|144218487|SUPERIORITY||Hazard Ratio (HR)|1.1||||0.672|TWO_SIDED|95.0|0.8|1.4|||Log Rank|||A Cox proportional hazards model was used to estimate the hazard ratio and its two-sided 95% CI.||1.4|0.8|0.672
72348294|NCT01724866|144218487|SUPERIORITY||Hazard Ratio (HR)|0.8||||0.348|TWO_SIDED|95.0|0.5|1.3|||Log Rank|||A Cox proportional hazards model was used to estimate the hazard ratio and its two-sided 95% CI.||1.3|0.5|0.348
72348295|NCT01724866|144218487|SUPERIORITY||Hazard Ratio (HR)|1.1||||0.973|TWO_SIDED|95.0|0.4|2.9|||Log Rank|||A Cox proportional hazards model was used to estimate the hazard ratio and its two-sided 95% CI.||2.9|0.4|0.973
72348296|NCT01724866|144218488|SUPERIORITY||Hazard Ratio (HR)|1.1||||0.618|TWO_SIDED|95.0|0.8|1.4|||Log Rank|||A Cox proportional hazards model was used to estimate the hazard ratio and its two-sided 95% CI.||1.4|0.8|0.618
72348297|NCT01724866|144218488|SUPERIORITY||Hazard Ratio (HR)|0.9||||0.661|TWO_SIDED|95.0|0.5|1.6|||Log Rank|||A Cox proportional hazards model was used to estimate the hazard ratio and its two-sided 95% CI.||1.6|0.5|0.661
72348298|NCT01724866|144218488|SUPERIORITY||Hazard Ratio (HR)|0.9||||0.754|TWO_SIDED|95.0|0.3|2.8|||Log Rank|||A Cox proportional hazards model was used to estimate the hazard ratio and its two-sided 95% CI.||2.8|0.3|0.754
72348299|NCT01724866|144218489|SUPERIORITY||Hazard Ratio (HR)|1.4||||0.009|TWO_SIDED|95.0|1.1|1.7|||Log Rank|||A Cox proportional hazards model was used to estimate the hazard ratio and its two-sided 95% CI.||1.7|1.1|0.009
72348300|NCT01724866|144218489|SUPERIORITY||Hazard Ratio (HR)|1.1||||0.527|TWO_SIDED|95.0|0.7|1.8|||Log Rank|||A Cox proportional hazards model was used to estimate the hazard ratio and its two-sided 95% CI.||1.8|0.7|0.527
72348301|NCT01724866|144218489|SUPERIORITY||Hazard Ratio (HR)|1.2||||0.815|TWO_SIDED|95.0|0.4|3.9|||Log Rank|||A Cox proportional hazards model was used to estimate the hazard ratio and its two-sided 95% CI.||3.9|0.4|0.815
72348302|NCT01724866|144218490|SUPERIORITY|||||||0.008|||||||Asymptotic Normality Assumption|P-values was obtained based upon asymptotic normality assumption on the log10 transformed data.||||||0.008
72348303|NCT01724866|144218490|SUPERIORITY|||||||0.911|||||||Asymptotic Normality Assumption|P-values was obtained based upon asymptotic normality assumption on the log10 transformed data.||||||0.911
72348304|NCT01724866|144218490|SUPERIORITY|||||||0.002|||||||Asymptotic Normality Assumption|P-values was obtained based upon asymptotic normality assumption on the log10 transformed data.||||||0.002
72348305|NCT01724866|144218491|SUPERIORITY|||||||0.005|||||||Asymptotic Normality Assumption|P-values was obtained based upon asymptotic normality assumption on the log10 transformed data.||||||0.005
72348306|NCT01724866|144218491|SUPERIORITY|||||||0.633|||||||Asymptotic Normality Assumption|P-values was obtained based upon asymptotic normality assumption on the log10 transformed data.||||||0.633
72348307|NCT01724866|144218491|SUPERIORITY|||||||0.027|||||||Asymptotic Normality Assumption|P-values was obtained based upon asymptotic normality assumption on the log10 transformed data.||||||0.027
72348308|NCT01724866|144218492|SUPERIORITY|||||||0.015|||||||Asymptotic Normality Assumption|P-values was obtained based upon asymptotic normality assumption on the log10 transformed data.||||||0.015
72348309|NCT01724866|144218492|SUPERIORITY|||||||0.571|||||||Asymptotic Normality Assumption|P-values was obtained based upon asymptotic normality assumption on the log10 transformed data.||||||0.571
72348310|NCT01724866|144218492|SUPERIORITY|||||||0.066|||||||Asymptotic Normality Assumption|P-values was obtained based upon asymptotic normality assumption on the log10 transformed data.||||||0.066
72348311|NCT01724866|144218493|SUPERIORITY|||||||0.106|||||||Asymptotic Normality Assumption|P-values was obtained based upon asymptotic normality assumption on the log10 transformed data.||||||0.106
72348312|NCT01724866|144218493|SUPERIORITY|||||||0.156|||||||Asymptotic Normality Assumption|P-values was obtained based upon asymptotic normality assumption on the log10 transformed data.||||||0.156
72348313|NCT01724866|144218493|SUPERIORITY|||||||0.005|||||||Asymptotic Normality Assumption|P-values was obtained based upon asymptotic normality assumption on the log10 transformed data.||||||0.005
72348314|NCT01724866|144218494|SUPERIORITY||Ratio|0.4|||||TWO_SIDED|95.0|0.25|0.8||||||||0.80|0.25|
72348315|NCT01724866|144218494|SUPERIORITY||Ratio|1.0|||||TWO_SIDED|95.0|0.53|2.04||||||||2.04|0.53|
72348316|NCT01724866|144218494|SUPERIORITY||Ratio|2.5|||||TWO_SIDED|95.0|1.4|4.54||||||||4.54|1.40|
72348317|NCT01724866|144218495|SUPERIORITY||Ratio|0.5|||||TWO_SIDED|95.0|0.3|0.8||||||||0.80|0.30|
72348318|NCT01724866|144218495|SUPERIORITY||Ratio|1.1|||||TWO_SIDED|95.0|0.7|1.79||||||||1.79|0.70|
72348319|NCT01724866|144218495|SUPERIORITY||Ratio|1.7|||||TWO_SIDED|95.0|1.07|2.79||||||||2.79|1.07|
72348320|NCT01724866|144218496|SUPERIORITY||Ratio|0.5|||||TWO_SIDED|95.0|0.34|0.89||||||||0.89|0.34|
72348321|NCT01724866|144218496|SUPERIORITY||Ratio|1.1|||||TWO_SIDED|95.0|0.71|1.85||||||||1.85|0.71|
72348322|NCT01724866|144218496|SUPERIORITY||Ratio|1.6|||||TWO_SIDED|95.0|0.97|2.49||||||||2.49|0.97|
72348323|NCT01724866|144218497|SUPERIORITY||Ratio|0.7|||||TWO_SIDED|95.0|0.4|1.1||||||||1.10|0.40|
72348324|NCT01724866|144218497|SUPERIORITY||Ratio|1.4|||||TWO_SIDED|95.0|0.87|2.38||||||||2.38|0.87|
72348325|NCT01724866|144218497|SUPERIORITY||Ratio|1.9|||||TWO_SIDED|95.0|1.23|2.96||||||||2.96|1.23|
72348326|NCT01724866|144218502|SUPERIORITY||Percent Difference|2.1||||1|TWO_SIDED|95.0|-20.2|24.9|||Fisher Exact|||||24.9|-20.2|1.000
72348327|NCT01724866|144218502|SUPERIORITY||Percent Difference|-2.8||||1|TWO_SIDED|95.0|-26.7|21.4|||Fisher Exact|||||21.4|-26.7|1.000
72348328|NCT01724866|144218502|SUPERIORITY||Percent Difference|-2.8||||1|TWO_SIDED|95.0|-26.7|21.4|||Fisher Exact|||||21.4|-26.7|1.000
72348329|NCT01724866|144218504|SUPERIORITY||Percent Difference|-6.2||||0.469|TWO_SIDED|95.0|-28.5|16.9|||Fisher Exact|||||16.9|-28.5|0.469
72348330|NCT01724866|144218504|SUPERIORITY||Percent Difference|-5.6||||0.71|TWO_SIDED|95.0|-29.3|18.7|||Fisher Exact|||||18.7|-29.3|0.710
72348331|NCT01724866|144218504|SUPERIORITY||Percent Difference|-11.1||||0.199|TWO_SIDED|95.0|-34.6|13.3|||Fisher Exact|||||13.3|-34.6|0.199
72348332|NCT01980095|144218536|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|||||||One-sample Z-test, RHB-105 subjects only|||||||0.001
72348333|NCT04273893|144218579|OTHER|||||||0.05||||||Changes from baseline ALC were conducted using repeated measures models with an unstructured covariance matrix and model terms for tumor location, follow-up time. Adjustments for stratification factors were made using least squares means.|t-test, 2 sided|||||||0.05
72348334|NCT01957202|144218582|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.255|||<|0.0001|TWO_SIDED|95.0|-2.895|-1.616|||Mixed Model ANOVA|||||-1.616|-2.895|<0.0001
72348335|NCT01957202|144218582|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.566|||<|0.0001|TWO_SIDED|95.0|-3.208|-1.925|||Mixed Model ANOVA|||||-1.925|-3.208|<0.0001
72348336|NCT01957202|144218582|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.531||||0.0003|TWO_SIDED|95.0|-2.342|-0.719|||Mixed Model ANOVA|||||-0.719|-2.342|0.0003
72348337|NCT01957202|144218582|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.842|||<|0.0001|TWO_SIDED|95.0|-2.654|-1.029|||Mixed Model ANOVA|||||-1.029|-2.654|<0.0001
72348338|NCT01957202|144218582|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.097|||<|0.0001|TWO_SIDED|95.0|-4.857|-3.337|||Mixed Model ANOVA|||||-3.337|-4.857|<0.0001
72348339|NCT01957202|144218582|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.311||||0.3699|TWO_SIDED|95.0|-0.994|0.372|||Mixed Model ANOVA|||||0.372|-0.994|0.3699
72348340|NCT01957202|144218583|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.364|||<|0.0001|TWO_SIDED|95.0|-1.853|-0.874|||Mixed Model ANOVA|||||-0.874|-1.853|<0.0001
72348341|NCT01957202|144218583|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.32||||0.1975|TWO_SIDED|95.0|-0.169|0.809|||Mixed Model ANOVA|||||0.809|-0.169|0.1975
72348342|NCT01957202|144218583|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.252|||<|0.0001|TWO_SIDED|95.0|-1.87|-0.635|||Mixed Model ANOVA|||||-0.635|-1.870|<0.0001
72348343|NCT01957202|144218583|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.432||||0.1648|TWO_SIDED|95.0|-0.179|1.042|||Mixed Model ANOVA|||||1.042|-0.179|0.1648
72348344|NCT01957202|144218583|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.932||||0.0016|TWO_SIDED|95.0|-1.506|-0.358|||Mixed Model ANOVA|||||-0.358|-1.506|0.0016
72348345|NCT01957202|144218583|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.684|||<|0.0001|TWO_SIDED|95.0|1.16|2.208|||Mixed Model ANOVA|||||2.208|1.160|<0.0001
72348346|NCT01957202|144218584|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.174||||0.3052|TWO_SIDED|95.0|-0.508|0.16|||Mixed Model ANOVA|||||0.160|-0.508|0.3052
72348347|NCT01957202|144218584|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.187||||0.2725|TWO_SIDED|95.0|-0.149|0.523|||Mixed Model ANOVA|||||0.523|-0.149|0.2725
72348348|NCT01957202|144218584|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.536||||0.0118|TWO_SIDED|95.0|-0.952|-0.12|||Mixed Model ANOVA|||||-0.120|-0.952|0.0118
72348349|NCT01957202|144218584|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.175||||0.4049|TWO_SIDED|95.0|-0.588|0.239|||Mixed Model ANOVA|||||0.239|-0.588|0.4049
72348350|NCT01957202|144218584|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.349||||0.0793|TWO_SIDED|95.0|-0.739|0.041|||Mixed Model ANOVA|||||0.041|-0.739|0.0793
72348351|NCT01957202|144218584|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.361||||0.0478|TWO_SIDED|95.0|0.004|0.719|||Mixed Model ANOVA|||||0.719|0.004|0.0478
72348352|NCT01957202|144218585|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.215||||0.1502|TWO_SIDED|95.0|-0.509|0.079|||Mixed Model ANOVA|||||0.079|-0.509|0.1502
72348353|NCT01957202|144218585|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.075||||0.6177|TWO_SIDED|95.0|-0.37|0.221|||Mixed Model ANOVA|||||0.221|-0.370|0.6177
72348354|NCT01957202|144218585|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.701||||0.0004|TWO_SIDED|95.0|-1.08|-0.322|||Mixed Model ANOVA|||||-0.322|-1.080|0.0004
72348355|NCT01957202|144218585|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.56||||0.0035|TWO_SIDED|95.0|-0.934|-0.187|||Mixed Model ANOVA|||||-0.187|-0.934|0.0035
72348356|NCT01957202|144218585|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.775|||<|0.0001|TWO_SIDED|95.0|-1.123|-0.428|||Mixed Model ANOVA|||||-0.428|-1.123|<0.0001
72348357|NCT01957202|144218585|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.14||||0.3807|TWO_SIDED|95.0|-0.175|0.456|||Mixed Model ANOVA|||||0.456|-0.175|0.3807
72348358|NCT01664182|144218598|OTHER|Two sided hypothesis. Wilcoxon rank-sum test comparing the two arms in terms of the ratio of the post-treatment levels divided by the baseline.||||||0.86||||||No adjustment for multiple comparisons. A-priori threshold for statistical significance is 0.05.|Wilcoxon (Mann-Whitney)|||Arm A vs Arm B shift test on Angiopoietin -- 2 prior to cycle 2. Wilcoxon rank-sum test p-value.||||0.86
72348359|NCT01664182|144218598|OTHER|Two sided hypothesis. Wilcoxon rank-sum test comparing the two arms in terms of the ratio of the post-treatment levels divided by the baseline.||||||0.76||||||Angiopoietin -- 2 prior to cycle 3.|Wilcoxon (Mann-Whitney)|||Angiopoietin -- 2 prior to cycle 3||||0.76
72348360|NCT01664182|144218598|OTHER|Two sided hypothesis. Wilcoxon rank-sum test comparing the two arms in terms of the ratio of the post-treatment levels divided by the baseline.||||||0.14||||||No adjustment for multiple comparison. A-priori threshold for statistical significance is 0.05.|Wilcoxon (Mann-Whitney)|||Tie--2 Prior to cycle 2||||0.14
72348361|NCT01664182|144218598|OTHER|Two sided hypothesis. Wilcoxon rank-sum test comparing the two arms in terms of the ratio of the post-treatment levels divided by the baseline.||||||0.069||||||No adjustment for multiple comparisons. A-priori threshold for statistical significance is 0.05.|Wilcoxon (Mann-Whitney)|||Tie -- 2 prior to cycle 3||||0.069
72348362|NCT01664182|144218598|OTHER|Two sided hypothesis. Wilcoxon rank-sum test comparing the two arms in terms of the ratio of the post-treatment levels divided by the baseline.||||||0.19||||||P-value is not adjusted for multiple comparisons. A-priori threshold for statistical significance is 0.05.|Wilcoxon (Mann-Whitney)|||VEGF -- A prior to cycle 2||||0.19
72348363|NCT01664182|144218598|OTHER|Two sided hypothesis. Wilcoxon rank-sum test comparing the two arms in terms of the ratio of the post-treatment levels divided by the baseline.||||||0.046||||||P-value is not adjusted for multiple comparisons. The a-priori threshold for statistical significance is 0.05.|Wilcoxon (Mann-Whitney)|||VEGF--A prior to cycle 3||||0.046
72348364|NCT01664182|144218598|OTHER|Two sided hypothesis. Wilcoxon rank-sum test comparing the two arms in terms of the ratio of the post-treatment levels divided by the baseline.||||||0.029||||||Not adjusted for multiple comparisons. A-priori threshold for statistical significance is 0.05|Wilcoxon (Mann-Whitney)|||PIGF Prior to Cycle 2||||0.029
72348365|NCT01664182|144218598|OTHER|Two sided hypothesis. Wilcoxon rank-sum test comparing the two arms in terms of the ratio of the post-treatment levels divided by the baseline.||||||0.2||||||P-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is 0.05|Wilcoxon (Mann-Whitney)|||PIGF prior to cycle 3||||0.20
72348366|NCT01664182|144218598|OTHER|Two sided hypothesis. Wilcoxon rank-sum test comparing the two arms in terms of the ratio of the post-treatment levels divided by the baseline.||||||0.11||||||The p-value was not adjusted for multiple comparisons. The a-priori threshold for statistical significance is 0.05|Wilcoxon (Mann-Whitney)|||VEGFR--3 prior to cycle 2||||0.11
72348367|NCT01664182|144218598|OTHER|Two sided hypothesis. Wilcoxon rank-sum test comparing the two arms in terms of the ratio of the post-treatment levels divided by the baseline.||||||0.068||||||P-value was not adjusted for multiple comparisons. The a-priori threshold for statistical significance was 0.05.|Wilcoxon (Mann-Whitney)|||VEGFR--3 prior to cycle 3||||0.068
72348368|NCT01664182|144218598|OTHER|Two sided hypothesis. Wilcoxon rank-sum test comparing the two arms in terms of the ratio of the post-treatment levels divided by the baseline.||||||0.61||||||The p-value was not adjusted for multiple comparisons. The a-priori threshold for statistical significance was 0.05|Wilcoxon (Mann-Whitney)|||VEGF--C prior to cycle 2||||0.61
72348369|NCT01664182|144218598|OTHER|Two sided hypothesis. Wilcoxon rank-sum test comparing the two arms in terms of the ratio of the post-treatment levels divided by the baseline.||||||0.27||||||Two sided hypothesis. Wilcoxon rank-sum test comparing the two arms in terms of the ratio of the post-treatment levels divided by the baseline.|Wilcoxon (Mann-Whitney)|||VEGF--C prior to cycle 3||||0.27
72348370|NCT01664182|144218598|OTHER|Two sided hypothesis. Wilcoxon rank-sum test comparing the two arms in terms of the ratio of the post-treatment levels divided by the baseline.||||||0.61||||||The p-value was not adjusted for multiple comparisons. The a-priori threshold for statistical significance was 0.05.|Wilcoxon (Mann-Whitney)|||IL--8 prior to cycle 2||||0.61
72348371|NCT01664182|144218598|OTHER|Two sided hypothesis. Wilcoxon rank-sum test comparing the two arms in terms of the ratio of the post-treatment levels divided by the baseline.||||||0.49||||||The p-value was not adjusted for multiple comparisons, and the a-priori threshold for statistical significance was 0.05|Wilcoxon (Mann-Whitney)|||IL--8 prior to cycle 3||||0.49
72348372|NCT01664182|144218598|OTHER|Two sided hypothesis. Wilcoxon rank-sum test comparing the two arms in terms of the ratio of the post-treatment levels divided by the baseline.||||||0.82||||||The p-value was not adjusted for multiple comparisons. The a-priori threshold for statistical significance was 0.05.|Wilcoxon (Mann-Whitney)|||ICAM--1 prior to cycle 2||||0.82
72348373|NCT01664182|144218598|OTHER|Two sided hypothesis. Wilcoxon rank-sum test comparing the two arms in terms of the ratio of the post-treatment levels divided by the baseline.||||||0.069||||||The p-value was not adjusted for multiple comparisons and the a priori threshold for statistical significance was 0.05.|Wilcoxon (Mann-Whitney)|||ICAM--1 prior to cycle 3||||0.069
72348374|NCT01664182|144218598|OTHER|Two sided hypothesis. Wilcoxon rank-sum test comparing the two arms in terms of the ratio of the post-treatment levels divided by the baseline.||||||0.34||||||The p-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|Wilcoxon (Mann-Whitney)|||VCAM--1 prior to cycle 2||||0.34
72348375|NCT01664182|144218598|OTHER|Two sided hypothesis. Wilcoxon rank-sum test comparing the two arms in terms of the ratio of the post-treatment levels divided by the baseline.||||||0.046||||||The p-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was set to 0.05.|Wilcoxon (Mann-Whitney)|||VCAM--1 prior to cycle 3||||0.046
72348376|NCT01664182|144218598|OTHER|Two sided hypothesis. Wilcoxon rank-sum test comparing the two arms in terms of the ratio of the post-treatment levels divided by the baseline.||||||0.11||||||The p-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was set to 0.05.|Wilcoxon (Mann-Whitney)|||FGF2 prior to cycle 2||||0.11
72348377|NCT01664182|144218598|OTHER|Two sided hypothesis. Wilcoxon rank-sum test comparing the two arms in terms of the ratio of the post-treatment levels divided by the baseline.||||||0.23||||||The p-value was adjusted for multiple comparisons. The a prior threshold for statistical significance was set to 0.05.|Wilcoxon (Mann-Whitney)|||FGF2 prior to cycle 3||||0.23
72348378|NCT01664182|144218598|OTHER|Two sided hypothesis. Wilcoxon rank-sum test comparing the two arms in terms of the ratio of the post-treatment levels divided by the baseline.||||||0.37||||||The p-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was set to 0.05.|Wilcoxon (Mann-Whitney)|||PDGF--AA prior to cycle 2||||0.37
72348379|NCT01664182|144218598|OTHER|Two sided hypothesis. Wilcoxon rank-sum test comparing the two arms in terms of the ratio of the post-treatment levels divided by the baseline.||||||0.35||||||The p-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was set to 0.05.|Wilcoxon (Mann-Whitney)|||PDGF--AA prior to cycle 3||||0.35
72348380|NCT02881762|144218619|OTHER|Comparison of mean change analyzed with unpaired t-test for parametric data. The test was performed with a significance level of 0.05 (two-sided).||||||0.13|||||||t-test, 2 sided|||Null hypothesis is that there is no difference in change in HCV viral load between Maraviroc and No Maraviroc||||0.13
72348381|NCT02881762|144218620|OTHER|Comparison of difference in mean analyzed with paired t-test for parametric data. The test was performed with a significance level of 0.05 (two-sided).|||||>|0.5|||||||t-test, 2 sided|||Null hypothesis is that there is no difference in HCV viral load between baseline and 7 days of maraviroc.||||>0.5
72348382|NCT01635855|144218646|SUPERIORITY_OR_OTHER||One-sided binomial|8.5|||<|0.025|TWO_SIDED|95.0|3.5|13.6||Ho (null): Ps \>= 22% versus Ha (alternate): Ps \< 22% where Ps is the proportion of subjects with common severe adverse events in the post-approval study. Ho is rejected if upper limit of the 95% CI of Ps \< 22% and the one-sided p-value \<= 0.025.|One sided binomial distribution|The upper limit of the 95% two-sided CI for a proportion is equivalent to the 97.5% one-sided CI for that proportion for normal approximations.||The analysis was performed by comparing the proportion of subjects with severe common adverse events in the post-market study to that occurred in the pre-market studies. It was pre-specified in the protocol that the proportion of subjects with severe common adverse events in the pre-market studies was 22%.||13.6|3.5|< 0.025
72348383|NCT03828019|144218647|SUPERIORITY||Odds Ratio (OR)|1.86||||0.029|TWO_SIDED|95.0|1.06|3.25|||Regression, Logistic|Adjusted for the 2 stratification variables (initial prednisone dose and immunosuppression use at baseline).|Estimated parameter is the Odds Ratios (ADA/CID). Result greater than 1 indicates ADA is superior in achieving successful corticosteroid sparing|The sample size estimation: Adalimumab was estimated to be successful in 75% of patients. The overall success rate with conventional immunosuppression was estimated to be 51%. A sample size of 222 (111 per treatment group) provided 90% power to detect a difference in cumulative percent of 75% versus 51%||3.25|1.06|0.029
72348384|NCT03828019|144218648|SUPERIORITY||Odds Ratio (OR)|1.91||||0.072|TWO_SIDED|95.0|0.94|3.86|||Regression, Logistic||Odds ADA/ Odds CID|Generalized estimating equations were used to fit logistic regression models to compare the cumulative proportion of corticosteroid sparing between the two treatment groups over time while accounting for correlation between replicate measurements on the same individual with an unstructured covariance matrix. 2 stratification variables (initial prednisone dose and immunosuppression use at baseline) were included||3.86|0.94|0.072
72348385|NCT03828019|144218649|SUPERIORITY||Odds Ratio (OR)|1.53||||0.3|TWO_SIDED|95.0|0.67|3.46|||Regression, Logistic||Odds ratio is ADA/CID where value greater than 1 indicates ADA is superior for corticosteroid (prednisone) discontinuation|Generalized estimating equations were used to fit logistic regression models to compare the cumulative proportion of corticosteroid sparing between the two treatment groups over time while accounting for correlation between replicate measurements on the same individual with an unstructured covariance matrix. 2 stratification variables (initial prednisone dose and immunosuppression use at baseline) were included||3.46|0.67|0.30
72348386|NCT03828019|144218650|SUPERIORITY||Odds Ratio (OR)|1.85||||0.028|TWO_SIDED|95.0|1.06|3.19|||Regression, Logistic||Odds ADA/ Odds CID where value greater than 1 indicate greater corticosteroid sparing success in the ADA group|Generalized estimating equations were used to fit logistic regression models to compare the cumulative proportion of corticosteroid discontinuation between the two treatment groups over time while accounting for correlation between replicate measurements on the same individual with an unstructured covariance matrix. 2 stratification variables (initial prednisone dose and immunosuppression use at baseline) were included||3.19|1.06|0.028
72348387|NCT03828019|144218651|SUPERIORITY||Ratio of rate of steroid (mg/day ADA/CID|0.86||||0.061|TWO_SIDED|95.0|0.73|1.01|||negative binomial model||Number greater than 1 would indicate rate of steroid use is higher in participants assigned to ADA|||1.01|0.73|0.061
72348388|NCT03828019|144218652|SUPERIORITY||Difference in mean change from BL|0.4||||0.77|TWO_SIDED|95.0|-2.3|3.1|||Mixed Models Analysis|||Mixed effects models were used with a linear link. The fixed effects included initial steroid dose and immunosuppression use at baseline. Additional visit indicators (months 1-12) and corresponding treatment by visit interaction terms. An unstructured correlation was used to model repeated measurements by eye . A person-level random intercept was added to account for between-eye correlations.||3.1|-2.3|0.77
72348389|NCT03828019|144218653|SUPERIORITY||Ratio of odds ratios|0.55||||0.028|TWO_SIDED|95.0|0.31|0.94|||Regression, Logistic||estimate is the ratio of odds ratios - OR ADA / OR CID. Value less than 1 indicates ADA is better at reducing macular edema.|Mixed effects models with a log link were used to assess treatment differences . The outcome measure was the odds ratio of having macular edema (OCT central subfield thickness \> 300 um) at 12 months compared to baseline (BL). The treatment effect was the ratio of Odds ratios (ADA/CID) at 12 months. Values less than one indicate improvement in macular edema for the ADA treatment group relative to the CID group. Decrease in subfield thickness is good||0.94|0.31|0.028
72348390|NCT03828019|144218654|SUPERIORITY||Risk Ratio (RR)|1.1||||0.76|TWO_SIDED|95.0|0.61|1.98|||negative binomial model|||||1.98|0.61|0.76
72348391|NCT03828019|144218655|SUPERIORITY||Cox Proportional Hazard|0.16||||0.014|TWO_SIDED|95.0|0.04|0.7|||Regression, Cox|||. Kaplan Meier techniques and Cox proportional hazards models were used to evaluate time to event outcomes||0.70|0.04|0.014
72348392|NCT03828019|144218656|SUPERIORITY||Cox Proportional Hazard|0.89||||0.74|TWO_SIDED|95.0|0.43|1.82|||Regression, Cox|||||1.82|0.43|0.74
72348393|NCT03828019|144218657|SUPERIORITY||Odds Ratio (OR)|0.76||||0.35|TWO_SIDED|95.0|0.43|1.34|||Ratio of odds ratios||Treatment comparison is the ratio of the odds ratios for each treatment group (ADA/CID) at 12 months. Values greater than one indicate greater improvement in health for the ADA treatment group relative to the CID group.|||1.34|0.43|0.35
72348394|NCT03828019|144218658|SUPERIORITY||Mean Difference (Net)|1.39||||0.24|TWO_SIDED|95.0|-0.95|3.73|||Mixed Models Analysis|||||3.73|-0.95|0.24
72348395|NCT03828019|144218659|SUPERIORITY||Mean Difference (Net)|0.59||||0.7|TWO_SIDED|95.0|-2.43|3.61|||Mixed Models Analysis|||||3.61|-2.43|0.70
72348396|NCT03828019|144218660|SUPERIORITY||Mean Difference (Net)|1.6||||0.28|TWO_SIDED|95.0|-1.4|4.6|||Mixed Models Analysis|||||4.6|-1.4|0.28
72348397|NCT03828019|144218661|SUPERIORITY||Hazard Ratio (HR)|0.21||||0.009|TWO_SIDED|95.0|0.07|0.67|||Regression, Cox|||||0.67|0.07|0.009
72348398|NCT03401671|144218690|OTHER|Analysis was performed for estimation of least square means only. Descriptive statistical analysis was the main analysis.|Ratio of Geometric least squares Means|1.0229|||||TWO_SIDED|90.0|0.8473|1.2349||||||An analysis of variance was performed with the natural log-transformed PK parameters as the dependent variable and ethnic group as a fixed effect.||1.2349|0.8473|
72348399|NCT03401671|144218692|OTHER|Analysis was performed for estimation of least square means only. Descriptive statistical analysis was the main analysis.|Ratio of Geometric least squares Means|0.9324|||||TWO_SIDED|90.0|0.8016|1.0846||||||An analysis of variance was performed with the natural log-transformed PK parameters as the dependent variable and ethnic group as a fixed effect.||1.0846|0.8016|
72348400|NCT03401671|144218693|OTHER|Analysis was performed for estimation of least square means only. Descriptive statistical analysis was the main analysis.|Ratio of Geometric least squares Means|0.9318|||||TWO_SIDED|90.0|0.8005|1.0846||||||An analysis of variance was performed with the natural log-transformed PK parameters as the dependent variable and ethnic group as a fixed effect.||1.0846|0.8005|
72348401|NCT04090242|144218710|OTHER||Mean Difference (Final Values)|-0.16||||0.392|TWO_SIDED|95.0|-0.53|0.21||The p value is for the comparison between interventional and control group on change of DES score between baseline and end of study.|Mixed Models Analysis|||With assumptions made in statistical analysis plan, a sample size of 43 subjects per arm had \>80% power to detect a significant difference between the two arms (based on a 2-sided t-test, 95% CI for DES difference between groups). Adding a 10% buffer, planned enrollment was 96 subjects. However, enrollment ended early with about 25 subjects in each arm (56 subjects total). Thus, power decreased to 56%. The study was not sufficiently powered under these conditions.||0.21|-0.53|0.392
72348402|NCT01898013|144218727|SUPERIORITY||Mean Difference (Final Values)|-0.56|STANDARD_ERROR_OF_MEAN|0.25||0.02|TWO_SIDED|||||a priori threshold set at 0.05|Mixed Models Analysis|||||||0.02
72348403|NCT01898013|144218728|SUPERIORITY||Mean Difference (Final Values)|0.83|STANDARD_ERROR_OF_MEAN|0.14||0.26|TWO_SIDED||||||Mixed Models Analysis|||||||0.26
72348404|NCT01898013|144218729|SUPERIORITY||Mean Difference (Final Values)|0.97|STANDARD_ERROR_OF_MEAN|0.12||0.79|TWO_SIDED||||||Mixed Models Analysis|||||||0.79
72348405|NCT01898013|144218730|SUPERIORITY||Mean Difference (Final Values)|1.18|STANDARD_ERROR_OF_MEAN|0.16||0.23|TWO_SIDED||||||Mixed Models Analysis|||||||0.23
72348406|NCT01898013|144218731|SUPERIORITY||Mean Difference (Final Values)|0.93|STANDARD_ERROR_OF_MEAN|0.13||0.63|TWO_SIDED||||||Mixed Models Analysis|||||||0.63
72348407|NCT01898013|144218732|SUPERIORITY||Mean Difference (Final Values)|1.06|STANDARD_ERROR_OF_MEAN|0.13||0.62|TWO_SIDED||||||Mixed Models Analysis|||||||0.62
72348408|NCT01100775|144218737|SUPERIORITY|||||||0.898|||||||Wilcoxon (Mann-Whitney)|||Comparison of RVIP Practice Mean Target Hits between Galantamine and Placebo Arms||||0.898
72348409|NCT01100775|144218737|SUPERIORITY|||||||0.701|||||||Wilcoxon (Mann-Whitney)|||Comparison of RVIP Practice Mean False Alarms between Galantamine and Placebo Arms||||0.701
72348410|NCT01100775|144218737|SUPERIORITY|||||||0.16|||||||Wilcoxon (Mann-Whitney)|||Comparison of RVIP First Half Mean Target Hits between Galantamine and Placebo Arms||||0.16
72348411|NCT01100775|144218737|SUPERIORITY|||||||0.701|||||||Wilcoxon (Mann-Whitney)|||Comparison of RVIP First Half Mean False Alarms between Galantamine and Placebo Arms||||0.701
72348412|NCT01100775|144218738|SUPERIORITY|||||||0.161|||||||Wilcoxon (Mann-Whitney)|||Comparison of RVIP Practice Mean Target Reaction Time between Galantamine and Placebo Arms||||0.161
72348413|NCT01100775|144218738|SUPERIORITY|||||||0.028|||||||Wilcoxon (Mann-Whitney)|||Comparison of RVIP Practice Mean False Alarm Reaction Time between Galantamine and Placebo Arms||||0.028
72348414|NCT01100775|144218738|SUPERIORITY|||||||0.899|||||||Wilcoxon (Mann-Whitney)|||Comparison of RVIP First Half Mean Target Reaction Time between Galantamine and Placebo Arms||||0.899
72348415|NCT01100775|144218738|SUPERIORITY|||||||0.521|||||||Wilcoxon (Mann-Whitney)|||Comparison of RVIP First Half Mean False Alarms Reaction Time between Galantamine and Placebo Arms||||0.521
72348416|NCT01100775|144218739|SUPERIORITY|||||||0.67|||||||Wilcoxon (Mann-Whitney)|||Comparison of the mean total amount offered during the trust game between the galantamine and placebo groups||||0.67
72348417|NCT01100775|144218740|SUPERIORITY|||||||0.32|||||||Wilcoxon (Mann-Whitney)|||Comparison of the mean correct responses between galantamine and placebo||||0.32
72348418|NCT01100775|144218741|SUPERIORITY|||||||0.659|||||||Wilcoxon (Mann-Whitney)|||Comparison of the number of correct response on Trial 1 between galantamine and placebo||||0.659
72348419|NCT01100775|144218741|SUPERIORITY|||||||0.541|||||||Wilcoxon (Mann-Whitney)|||Comparison of the number of correct response on Trial 2 between galantamine and placebo||||0.541
72348420|NCT01100775|144218741|SUPERIORITY|||||||0.838|||||||Wilcoxon (Mann-Whitney)|||Comparison of the number of correct response on Trial 3 between galantamine and placebo||||0.838
72348421|NCT01100775|144218742|SUPERIORITY|||||||0.548|||||||Wilcoxon (Mann-Whitney)|||A comparison the mean correct responses between galantamine and placebo||||0.548
72348422|NCT01100775|144218743|SUPERIORITY|||||||0.871|||||||Wilcoxon (Mann-Whitney)|||||||0.871
72348423|NCT01100775|144218744|SUPERIORITY|||||||0.626|||||||Wilcoxon (Mann-Whitney)|||Comparison of Overall Affect between galantamine and placebo||||0.626
72348424|NCT01100775|144218744|SUPERIORITY|||||||0.234|||||||Wilcoxon (Mann-Whitney)|||Comparison of Overall Social Skill between galantamine and placebo||||0.234
72348425|NCT01100775|144218745|SUPERIORITY|||||||0.797|||||||Wilcoxon (Mann-Whitney)|||Comparison of Facial Affect Total Responses between galantamine and placebo||||0.797
72348426|NCT01100775|144218745|SUPERIORITY|||||||0.669|||||||Wilcoxon (Mann-Whitney)|||Comparison of Facial Affect Total Hits between galantamine and placebo||||0.669
72348427|NCT01100775|144218745|SUPERIORITY|||||||0.668|||||||Wilcoxon (Mann-Whitney)|||Comparison of Facial Affect Total False Alarms between galantamine and placebo||||0.668
72348428|NCT03182907|144218746|OTHER|The AUC0-inf of bezlotoxumab in Cohort 1 was compared to the AUC0-inf of bezlotoxumab in adults using an analysis of variance (ANOVA) model. The comparison adult PK dataset used was based on participants from 2 adult trials (NCT01241552 and NCT01513239) as a historical control.|Geometric Mean Ratio (GMR)|1.06|||||TWO_SIDED|90.0|0.95|1.18|||||GMR was calculated as the Cohort 1 geometric mean (GM) AUC0-inf / Adult GM AUC0-inf.|||1.18|0.95|
72348429|NCT03182907|144218746|OTHER|The AUC0-inf of bezlotoxumab in Cohort 2 was compared to the AUC0-inf of bezlotoxumab in adults using an analysis of variance (ANOVA) model. The comparison adult PK dataset used was based on participants from 2 adult trials (NCT01241552 and NCT01513239) as a historical control.|GMR|0.82|||||TWO_SIDED|90.0|0.75|0.89|||||GMR was calculated as the Cohort 2 GM AUC0-inf / Adult GM AUC0-inf.|||0.89|0.75|
72348430|NCT03182907|144218747|OTHER|Miettinen \& Nurminen method was used to generate the estimated difference in percentage and associated 95% confidence intervals (CIs) in bezlotoxumab versus placebo arms.|Difference in percentage|-5.7|||||TWO_SIDED|95.0|-14.5|7.7||||||||7.7|-14.5|
72348431|NCT03182907|144218748|OTHER|Miettinen \& Nurminen method was used to generate the estimated difference in percentage and associated 95% CIs in bezlotoxumab versus placebo arms.|Difference in percentage|0.0|||||TWO_SIDED|95.0|-9.7|3.5||||||||3.5|-9.7|
72348432|NCT03182907|144218749|OTHER|Miettinen and Nurminen method stratified by age cohort (12 to \<18 years of age, 1 to \<12 years of age) with a Cochran-Mantel-Haenszel weight was used to generate the treatment difference, associated 95% CIs and a 2-sided p-value.|Adjusted difference|-3.7|||=|0.5701|TWO_SIDED|95.0|-20.0|8.0|||Stratified Miettinen and Nurminen method|||||8.0|-20.0|= 0.5701
72348433|NCT03182907|144218750|OTHER|Miettinen and Nurminen method stratified by age cohort (12 to \<18 years of age, 1 to \<12 years of age) with a Cochran-Mantel-Haenszel weight was used to generate the treatment difference, associated 95% CIs and a 2-sided p-value.|Adjusted difference|0.8|||=|0.9165|TWO_SIDED|95.0|-11.8|17.6|||Stratified Miettinen and Nurminen method|||||17.6|-11.8|= 0.9165
72348434|NCT03182907|144218751|OTHER|Unstratified Miettinen and Nurminen method was used to generate the treatment difference, associated 95% CIs and a 2-sided p-value.|Adjusted Difference|-3.1|||=|0.6542|TWO_SIDED|95.0|-19.9|9.0|||Unstratified Miettinen & Nurminen method|||||9.0|-19.9|= 0.6542
72348435|NCT03182907|144218752|OTHER|Unstratified Miettinen and Nurminen method was used to generate treatment difference, associated 95% CIs and a 2-sided p-value.|Adjusted difference|0.1|||=|0.9873|TWO_SIDED|95.0|-13.0|17.4|||Unstratified Miettinen & Nurminen method|||||17.4|-13.0|= 0.9873
72348436|NCT00429169|144218756|SUPERIORITY_OR_OTHER||regression coefficient|-0.29||||0.03|TWO_SIDED|95.0|-0.57|-0.023||The p-value applies to the interaction term of Treatment X Baseline Suicidal Ideation severity.|Mixed Models Analysis|||Generalized least squares model of Scale for Suicidal Ideation score during 8-week acute treatment of major depressive disorder.||-0.023|-0.57|0.03
72348437|NCT02815644|144218777|SUPERIORITY_OR_OTHER||T/R ratio|55.69|STANDARD_ERROR_OF_MEAN|1.087|||TWO_SIDED|90.0|48.22|64.33|||||Standard Error of the mean is actually geometric Standard Error of the mean.|"Relative bioavailability of linagliptin after food intake compared to while in the fasting state was assessed using an ANOVA on the basis of the log transformed PK parameters. This model for the evaluation of effect of food on bioavailability included the effects: sequence, subjects within sequences, period, and treatment (i.e., feeding status). The effect subjects within sequences was considered as random, whereas the other effects were considered as fixed."||64.33|48.22|
72370173|NCT00838513|144250677|SUPERIORITY_OR_OTHER||Percent of platelet count normalization|90.0|||||TWO_SIDED|95.0|68.0|99.0||||||All analyses were based on the pooled data from the two protocols: C08-003A (adult) and C08-003B (adolescent), a similar protocol, for patients \<18 years||99|68|
72370174|NCT00573144|144250713|SUPERIORITY_OR_OTHER|||||||0.97|||||||t-test, 2 sided|||||||0.97
72370175|NCT00573144|144250714|SUPERIORITY_OR_OTHER|||||||0.35|||||||t-test, 2 sided|||||||0.35
72370176|NCT00573144|144250715|SUPERIORITY_OR_OTHER|||||||0.26|||||||t-test, 2 sided|||||||0.26
72370177|NCT00670306|144250765|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.6|STANDARD_DEVIATION|7.1|<|0.001|||||||t-test, 2 sided|||||||<0.001
72348438|NCT02815644|144218778|SUPERIORITY_OR_OTHER||T/R ratio|74.89|STANDARD_ERROR_OF_MEAN|1.073|||TWO_SIDED|90.0|66.27|84.64|||||Standard Error of the mean is actually geometric Standard Error of the mean|"Relative bioavailability of empagliflozin was assessed using an ANOVA on the basis of the log transformed PK parameters. This model for the evaluation of effect of food on bioavailability included the effects: sequence, subjects within sequences, period, and treatment (i.e., feeding status). The effect subjects within sequences was considered as random, whereas the other effects were considered as fixed."||84.64|66.27|
72348439|NCT02815644|144218779|SUPERIORITY_OR_OTHER||T/R ratio|82.19|STANDARD_ERROR_OF_MEAN|1.028|||TWO_SIDED|90.0|78.38|86.18|||||Standard Error of the mean is actually geometric Standard Error of the mean|"Relative bioavailability of linagliptin was assessed using an ANOVA on the basis of the log transformed PK parameters. This model for the evaluation of effect of food on bioavailability included the effects: sequence, subjects within sequences, period, and treatment (i.e., feeding status). The effect subjects within sequences was considered as random, whereas the other effects were considered as fixed."||86.18|78.38|
72348440|NCT02815644|144218780|SUPERIORITY_OR_OTHER||T/R ratio|85.99|STANDARD_ERROR_OF_MEAN|1.018|||TWO_SIDED|90.0|83.38|88.68|||||Standard Error of the mean is actually geometric Standard Error of the mean|"Relative bioavailability of empagliflozin was assessed using an ANOVA on the basis of the log transformed PK parameters. This model for the evaluation of effect of food on bioavailability included the effects: sequence, subjects within sequences, period, and treatment (i.e., feeding status). The effect subjects within sequences was considered as random, whereas the other effects were considered as fixed."||88.68|83.38|
72348441|NCT02815644|144218781|SUPERIORITY_OR_OTHER||T/R ratio|88.13|STANDARD_ERROR_OF_MEAN|1.051|||TWO_SIDED|90.0|80.89|96.03|||||Standard Error of the mean is actually geometric Standard Error of the mean|"Relative bioavailability of linagliptin was assessed using an ANOVA on the basis of the log transformed PK parameters. This model for the evaluation of effect of food on bioavailability included the effects: sequence, subjects within sequences, period, and treatment (i.e., feeding status). The effect subjects within sequences was considered as random, whereas the other effects were considered as fixed."||96.03|80.89|
72348442|NCT02815644|144218782|SUPERIORITY_OR_OTHER||T/R ratio|86.33|STANDARD_ERROR_OF_MEAN|1.019|||TWO_SIDED|90.0|83.61|89.13|||||Standard Error of the mean is actually geometric Standard Error of the mean|"Relative bioavailability of empagliflozin was assessed using an ANOVA on the basis of the log transformed PK parameters. This model for the evaluation of effect of food on bioavailability included the effects: sequence, subjects within sequences, period, and treatment (i.e., feeding status). The effect subjects within sequences was considered as random, whereas the other effects were considered as fixed."||89.13|83.61|
72348443|NCT02815644|144218783|SUPERIORITY_OR_OTHER||T/R Ratio|82.19|STANDARD_ERROR_OF_MEAN|1.028|||TWO_SIDED|90.0|78.38|86.18|||||Standard Error of the mean is actually geometric Standard Error of the mean|"Relative bioavailability of linagliptin was assessed using an ANOVA on the basis of the log transformed PK parameters. This model for the evaluation of effect of food on bioavailability included the effects: sequence, subjects within sequences, period, and treatment (i.e., feeding status). The effect subjects within sequences was considered as random, whereas the other effects were considered as fixed."||86.18|78.38|
72348444|NCT03364309|144218789|SUPERIORITY||Odds Ratio (OR)|99.99|||<|0.0001|TWO_SIDED|95.0|33.57|99.99|||Regression, Logistic|||||99.99|33.57|<0.0001
72348445|NCT03364309|144218789|SUPERIORITY||Odds Ratio (OR)|99.99|||<|0.001|TWO_SIDED|95.0|52.49|99.99|||Regression, Logistic|||||99.99|52.49|<0.001
72348446|NCT03364309|144218790|SUPERIORITY||Odds Ratio (OR)|79.95|||<|0.001|TWO_SIDED|95.0|32.76|99.99|||Regression, Logistic|||||99.99|32.76|<0.001
72348447|NCT03364309|144218790|SUPERIORITY||Odds Ratio (OR)|99.99|||<|0.001|TWO_SIDED|95.0|64.87|99.99|||Regression, Logistic|||||99.99|64.87|<0.001
72348448|NCT03364309|144218792|SUPERIORITY||Odds Ratio (OR)|99.99|||<|0.001|TWO_SIDED|95.0|31.88|99.99|||Regression, Logistic|||||99.99|31.88|<0.001
72348449|NCT03364309|144218792|SUPERIORITY||Odds Ratio (OR)|99.99|||<|0.001|TWO_SIDED|95.0|46.96|99.99|||Regression, Logistic|||||99.99|46.96|<0.001
72348450|NCT03364309|144218794|SUPERIORITY||Odds Ratio (OR)|37.24|||<|0.001|TWO_SIDED|95.0|13.68|99.99|||Regression, Logistic|||||99.99|13.68|<0.001
72348451|NCT03364309|144218794|SUPERIORITY||Odds Ratio (OR)|41.38|||<|0.001|TWO_SIDED|95.0|15.09|99.99|||Regression, Logistic|||||99.99|15.09|<0.001
72348452|NCT03364309|144218795|SUPERIORITY||LSMean Difference|-9.52|STANDARD_ERROR_OF_MEAN|0.604|<|0.001|TWO_SIDED|95.0|-10.71|-8.33|||Mixed Models Analysis|||||-8.33|-10.71|<0.001
72348453|NCT03364309|144218795|SUPERIORITY||LSMean Difference|-9.78|STANDARD_ERROR_OF_MEAN|0.603|<|0.001|TWO_SIDED|95.0|-10.96|-8.59|||Mixed Models Analysis|||||-8.59|-10.96|<0.001
72348454|NCT03364309|144218796|SUPERIORITY||LSMean Difference|-10.09|STANDARD_ERROR_OF_MEAN|1.673|<|0.001|TWO_SIDED|95.0|-13.38|-6.79|||Mixed Models Analysis|||||-6.79|-13.38|<0.001
72348455|NCT03364309|144218796|SUPERIORITY||LSMean Difference|-8.81|STANDARD_ERROR_OF_MEAN|1.677|<|0.001|TWO_SIDED|95.0|-12.11|-5.51|||Mixed Models Analysis|||||-5.51|-12.11|<0.001
72348456|NCT03364309|144218797|SUPERIORITY||LSMean Difference|-34.96|STANDARD_ERROR_OF_MEAN|2.023|<|0.001|TWO_SIDED|95.0|-38.94|-30.98|||Mixed Models Analysis|||||-30.98|-38.94|<0.001
72348457|NCT03364309|144218797|SUPERIORITY||LSMean Difference|-36.34|STANDARD_ERROR_OF_MEAN|2.018|<|0.001|TWO_SIDED|95.0|-40.3|-32.37|||Mixed Models Analysis|||||-32.37|-40.30|<0.001
72348458|NCT03364309|144218798|SUPERIORITY||LSMean Difference|-16.74|STANDARD_ERROR_OF_MEAN|0.957|<|0.001|TWO_SIDED|95.0|-18.62|-14.86|||Mixed Models Analysis|||||-14.86|-18.62|<0.001
72348459|NCT03364309|144218798|SUPERIORITY||LSMean Difference|-17.93|STANDARD_ERROR_OF_MEAN|0.954|<|0.001|TWO_SIDED|95.0|-19.8|-16.05|||Mixed Models Analysis|||||-16.05|-19.80|<0.001
72348460|NCT03364309|144218799|SUPERIORITY||LSMean Difference|6.228|STANDARD_ERROR_OF_MEAN|0.6681|<|0.001|TWO_SIDED|95.0|4.915|7.541|||Mixed Models Analysis|||||7.541|4.915|<0.001
72348461|NCT03364309|144218799|SUPERIORITY||LSMean Difference|6.536|STANDARD_ERROR_OF_MEAN|0.6668|<|0.001|TWO_SIDED|95.0|5.225|7.847|||Mixed Models Analysis|||||7.847|5.225|<0.001
72348462|NCT03364309|144218800|SUPERIORITY||LSMean Difference|5.193|STANDARD_ERROR_OF_MEAN|0.9489|<|0.001|TWO_SIDED|95.0|3.328|7.058|||Mixed Models Analysis|||||7.058|3.328|<0.001
72348463|NCT03364309|144218800|SUPERIORITY||LSMean Difference|5.362|STANDARD_ERROR_OF_MEAN|0.946|<|0.001|TWO_SIDED|95.0|3.503|7.222|||Mixed Models Analysis|||||7.222|3.503|<0.001
72348464|NCT03364309|144218801|SUPERIORITY||LSMean Difference|-2.6|STANDARD_ERROR_OF_MEAN|0.15|<|0.001|TWO_SIDED|95.0|-2.9|-2.4|||Mixed Models Analysis|||||-2.4|-2.9|<0.001
72348465|NCT03364309|144218801|SUPERIORITY||LSMean Difference|-2.6|STANDARD_ERROR_OF_MEAN|0.15|<|0.001|TWO_SIDED|95.0|-2.9|-2.3|||Mixed Models Analysis|||||-2.3|-2.9|<0.001
72348466|NCT03364309|144218802|SUPERIORITY||LSMean Difference|-3.35|STANDARD_ERROR_OF_MEAN|1.11||0.003|TWO_SIDED|95.0|-5.56|-1.15|||Mixed Models Analysis|||||-1.15|-5.56|0.003
72348467|NCT03364309|144218802|SUPERIORITY||LSMean Difference|-4.79|STANDARD_ERROR_OF_MEAN|1.064|<|0.001|TWO_SIDED|95.0|-6.9|-2.67|||Mixed Models Analysis|||||-2.67|-6.90|<0.001
72348468|NCT03364309|144218803|SUPERIORITY||LSMean Difference|-27.4|STANDARD_ERROR_OF_MEAN|11.07||0.022|TWO_SIDED|95.0|-50.5|-4.3|||Mixed Models Analysis|||||-4.3|-50.5|0.022
72348469|NCT03364309|144218803|SUPERIORITY||LSMean Difference|-25.2|STANDARD_ERROR_OF_MEAN|10.87||0.031|TWO_SIDED|95.0|-47.8|-2.5|||Mixed Models Analysis|||||-2.5|-47.8|0.031
72348470|NCT03304873|144218807|SUPERIORITY|||||||0.0004|||||||t-test, 1 sided|||||||0.0004
72348471|NCT03304873|144218808|SUPERIORITY|||||||0.99|||||||t-test, 1 sided|||||||0.99
72348472|NCT01052077|144218819|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.18||||0.1416|TWO_SIDED|95.0|-2.75|0.39||ANCOVA model, with treatment and study center as main effects and Week 8 value as convariate, is used for change from Week 8 comparisons.|ANCOVA|Treatment difference = difference in adjusted mean change: brexpiprazole - placebo.||Week 14||0.39|-2.75|0.1416
72348473|NCT01052077|144218820|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.22||||0.3778|TWO_SIDED|95.0|-0.69|0.26||ANCOVA model, with treatment and study center as main effects and Week 8 value as covariate, is used for change from Week 8 comparisons.|ANCOVA|Treatment difference = difference in adjusted mean change: brexpiprazole - placebo.||Week 14||0.26|-0.69|0.3778
72348474|NCT01052077|144218821|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.31||||0.0162|TWO_SIDED|95.0|-2.38|-0.24||ANCOVA model, with treatment and trial center as main effects and Week 8 value as covariate, was used for change from Week 8 comparisons.|ANCOVA|Treatment difference = difference in adjusted mean change: brexpiprazole - placebo.||Week 9||-0.24|-2.38|0.0162
72348475|NCT01052077|144218821|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.9||||0.0031|TWO_SIDED|95.0|-3.15|-0.65||ANCOVA model, with treatment and trial center as main effects and Week 8 value as covariate, was used for change from Week 8 comparisons.|ANCOVA|Treatment difference = difference in adjusted mean change: brexpiprazole - placebo.||Week 10||-0.65|-3.15|0.0031
72348476|NCT01052077|144218821|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.01||||0.0061|TWO_SIDED|95.0|-3.44|-0.58||ANCOVA model, with treatment and trial center as main effects and Week 8 value as covariate, was used for change from Week 8 comparisons.|ANCOVA|Treatment difference = difference in adjusted mean change: brexpiprazole - placebo.||Week 11||-0.58|-3.44|0.0061
72348477|NCT01052077|144218821|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.21||||0.0038|TWO_SIDED|95.0|-3.69|-0.72||ANCOVA model, with treatment and trial center as main effects and Week 8 value as covariate, was used for change from Week 8 comparisons.|ANCOVA|Treatment difference = difference in adjusted mean change: brexpiprazole - placebo.||Week 12||-0.72|-3.69|0.0038
72348478|NCT01052077|144218821|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.82||||0.0174|TWO_SIDED|95.0|-3.32|-0.32||ANCOVA model, with treatment and trial center as main effects and Week 8 value as covariate, was used for change from Week 8 comparisons.|ANCOVA|Treatment difference = difference in adjusted mean change: brexpiprazole - placebo.||Week 13||-0.32|-3.32|0.0174
72348479|NCT01052077|144218821|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.18||||0.1416|TWO_SIDED|95.0|-2.75|0.39||ANCOVA model, with treatment and trial center as main effects and Week 8 value as covariate, was used for change from Week 8 comparisons.|ANCOVA|Treatment difference = difference in adjusted mean change: brexpiprazole - placebo.||Week 14||0.39|-2.75|0.1416
72348480|NCT01052077|144218822|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.09||||0.1481|TWO_SIDED|95.0|-0.21|0.03||ANCOVA model, with treatment and study center as main effects and Week 8 value as covariate, is used for change from Week 8 comparisons.|ANCOVA|Treatment difference = difference in adjusted mean change: brexpiprazole - placebo.||Week 9||0.03|-0.21|0.1481
72348481|NCT01052077|144218822|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.14||||0.0691|TWO_SIDED|95.0|-0.28|0.01||ANCOVA model, with treatment and trial center as main effects and Week 8 value as covariate, was used for change from Week 8 comparisons.|ANCOVA|Treatment difference = difference in adjusted mean change: brexpiprazole - placebo.||Week 10||0.01|-0.28|0.0691
72348482|NCT01052077|144218822|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.17||||0.0457|TWO_SIDED|95.0|-0.35|0.0||ANCOVA model, with treatment and trial center as main effects and Week 8 value as covariate, was used for change from Week 8 comparisons.|ANCOVA|Treatment difference = difference in adjusted mean change: brexpiprazole - placebo.||Week 11||-0.00|-0.35|0.0457
72348483|NCT01052077|144218822|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.26||||0.0061|TWO_SIDED|95.0|-0.45|-0.08||ANCOVA model, with treatment and trial center as main effects and Week 8 value as covariate, was used for change from Week 8 comparisons.|ANCOVA|Treatment difference = difference in adjusted mean change: brexpiprazole - placebo.||Week 12||-0.08|-0.45|0.0061
72348484|NCT01052077|144218822|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.19||||0.0572|TWO_SIDED|95.0|-0.38|0.01||ANCOVA model, with treatment and trial center as main effects and Week 8 value as covariate, was used for change from Week 8 comparisons.|ANCOVA|Treatment difference = difference in adjusted mean change: brexpiprazole - placebo.||Week 13||0.01|-0.38|0.0572
72348485|NCT01052077|144218822|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.3318|TWO_SIDED|95.0|-0.29|0.1||ANCOVA model, with treatment and trial center as main effects and Week 8 value as covariate, was used for change from Week 8 comparisons.|ANCOVA|Treatment difference = difference in adjusted mean change: brexpiprazole - placebo.||Week 14||0.10|-0.29|0.3318
72348486|NCT01052077|144218823|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.34||||0.6272|TWO_SIDED|95.0|-1.02|1.69||ANCOVA model, with treatment and trial center as main effects and Week 8 value as covariate, was used for change from Week 8 comparisons.|ANCOVA|Treatment difference = difference in adjusted mean change: brexpiprazole - placebo.||Week 9||1.69|-1.02|0.6272
72348487|NCT01052077|144218823|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.03||||0.9697|TWO_SIDED|95.0|-1.48|1.54||ANCOVA model, with treatment and trial center as main effects and Week 8 value as covariate, was used for change from Week 8 comparisons.|ANCOVA|Treatment difference = difference in adjusted mean change: brexpiprazole - placebo||Week 10||1.54|-1.48|0.9697
72348488|NCT01052077|144218823|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.28||||0.749|TWO_SIDED|95.0|-2.0|1.44||ANCOVA model, with treatment and trial center as main effects and Week 8 value as covariate, was used for change from Week 8 comparisons.|ANCOVA|Treatment difference = difference in adjusted mean change: brexpiprazole - placebo.||Week 11||1.44|-2.00|0.7490
72348489|NCT01052077|144218823|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.06||||0.9459|TWO_SIDED|95.0|-1.94|1.81||ANCOVA model, with treatment and trial center as main effects and Week 8 value as covariate, was used for change from Week 8 comparisons.|ANCOVA|Treatment difference = difference in adjusted mean change: brexpiprazole - placebo.||Week 12||1.81|-1.94|0.9459
72348490|NCT01052077|144218823|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01||||0.9893|TWO_SIDED|95.0|-1.91|1.88||ANCOVA model, with treatment and trial center as main effects and Week 8 value as covariate, was used for change from Week 8 comparisons.|ANCOVA|Treatment difference = difference in adjusted mean change: brexpiprazole - placebo.||Week 13||1.88|-1.91|0.9893
72348491|NCT01052077|144218823|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.14||||0.8918|TWO_SIDED|95.0|-1.89|2.17||ANCOVA model, with treatment and trial center as main effects and Week 8 value as covariate, was used for change from Week 8 comparisons.|ANCOVA|Treatment difference = difference in adjusted mean change: brexpiprazole - placebo.||Week 14||2.17|-1.89|0.8918
72348492|NCT01052077|144218824|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.57||||0.3247|TWO_SIDED|95.0|-1.71|0.57||ANCOVA model, with treatment and trial center as main effects and Week 8 value as covariate, was used for change from Week 8 comparisons.|ANCOVA|Treatment difference = difference in adjusted mean change: brexpiprazole - placebo.||Week 14||0.57|-1.71|0.3247
72348493|NCT01052077|144218825|SUPERIORITY_OR_OTHER|||||||0.5616||||||Cohran-Mantel-Haenszel (CMH) row mean scores differ test controlling for study center.|Cochran-Mantel-Haenszel|Treatment difference = difference in adjusted mean: brexpiprazole - placebo.||Week 9||||0.5616
72348494|NCT01052077|144218825|SUPERIORITY_OR_OTHER|||||||0.19||||||CMH row mean scores differ test controlling for study center.|Cochran-Mantel-Haenszel|Treatment difference = difference in adjusted mean change: brexpiprazole - placebo.||Week 10||||0.1900
72348495|NCT01052077|144218825|SUPERIORITY_OR_OTHER|||||||0.0501||||||CMH row mean scores differ test controlling for study center.|Cochran-Mantel-Haenszel|Treatment difference = difference in adjusted mean change: brexpiprazole - placebo.||Week 11||||0.0501
72348496|NCT01052077|144218825|SUPERIORITY_OR_OTHER|||||||0.0137||||||CMH row mean scores differ test controlling for study center.|Cochran-Mantel-Haenszel|Treatment difference = difference in adjusted mean change: brexpiprazole - placebo.||Week 12||||0.0137
72348497|NCT01052077|144218825|SUPERIORITY_OR_OTHER|||||||0.0711||||||CMH row mean scores differ test controlling for study center.|Cochran-Mantel-Haenszel|Treatment difference = difference in adjusted mean change: brexpiprazole - placebo.||Week 13||||0.0711
72348498|NCT01052077|144218825|SUPERIORITY_OR_OTHER|||||||0.3438||||||CMH row mean scores differ test controlling for study center.|Cochran-Mantel-Haenszel|Treatment difference = difference in adjusted mean change: brexpiprazole - placebo.||Week 14||||0.3438
72348499|NCT01052077|144218826|SUPERIORITY_OR_OTHER||Ratio of Response rate|2.79||||0.0679|TWO_SIDED|95.0|0.88|8.81|||Cochran-Mantel-Haenszel|The CMH general association test controlling for trial center.||Week 9||8.81|0.88|0.0679
72348500|NCT01052077|144218826|SUPERIORITY_OR_OTHER||Ratio of Response Rate|1.78||||0.036|TWO_SIDED|95.0|1.01|3.14|||Cochran-Mantel-Haenszel|The CMH general association test controlling for trial center.||Week 10||3.14|1.01|0.0360
72348501|NCT01052077|144218826|SUPERIORITY_OR_OTHER||Ratio of Response Rate|1.53||||0.0521|TWO_SIDED|95.0|0.99|2.35|||Cochran-Mantel-Haenszel|The CMH general association test controlling for trial center.||Week 11||2.35|0.99|0.0521
72348502|NCT01052077|144218826|SUPERIORITY_OR_OTHER||Ratio of Response Rate|1.93||||0.0008|TWO_SIDED|95.0|1.31|2.86|||Cochran-Mantel-Haenszel|The CMH general association test controlling for trial center.||Week 12||2.86|1.31|0.0008
72348503|NCT01052077|144218826|SUPERIORITY_OR_OTHER||Ratio of Response Rate|1.64||||0.0074|TWO_SIDED|95.0|1.14|2.38|||Cochran-Mantel-Haenszel|The CMH general association test controlling for trial center.||Week 13||2.38|1.14|0.0074
72348504|NCT01052077|144218826|SUPERIORITY_OR_OTHER||Ratio of Response Rate|1.47||||0.0339|TWO_SIDED|95.0|1.03|2.08|||Cochran-Mantel-Haenszel|The CMH general association test controlling for trial center.||Week 14||2.08|1.03|0.0339
72348505|NCT01052077|144218827|SUPERIORITY_OR_OTHER||Ratio of Remission Rate|2.27||||0.2404|TWO_SIDED|95.0|0.55|9.3|||Cochran-Mantel-Haenszel|The CMH general association test controlling for trial center.||Week 9||9.30|0.55|0.2404
72348506|NCT01052077|144218827|SUPERIORITY_OR_OTHER||Ratio of Remission Rate|2.04||||0.0983|TWO_SIDED|95.0|0.83|4.98|||Cochran-Mantel-Haenszel|The CMH general association test controlling for trial center.||Week 10||4.98|0.83|0.0983
72348507|NCT01052077|144218827|SUPERIORITY_OR_OTHER||Ratio of Remission Rate|1.67||||0.0496|TWO_SIDED|95.0|0.99|2.82|||Cochran-Mantel-Haenszel|The CMH general association test controlling for trial center.||Week 11||2.82|0.99|0.0496
72348508|NCT01052077|144218827|SUPERIORITY_OR_OTHER||Ratio of Remission Rate|2.12||||0.0019|TWO_SIDED|95.0|1.31|3.46|||Cochran-Mantel-Haenszel|The CMH general association test controlling for trial center.||Week 12||3.46|1.31|0.0019
72348509|NCT01052077|144218827|SUPERIORITY_OR_OTHER||Ratio of Response Rate|1.77||||0.0068|TWO_SIDED|95.0|1.17|2.67|||Cochran-Mantel-Haenszel|The CMH general association test controlling for trial center.||Week 13||2.67|1.17|0.0068
72348510|NCT01052077|144218827|SUPERIORITY_OR_OTHER||Ratio of Remission Rate|1.71||||0.0089|TWO_SIDED|95.0|1.14|2.57||The CMH general association test controlling for trial center.|Cochran-Mantel-Haenszel|Treatment difference = difference in adjusted mean change: brexpiprazole - placebo.||Week 14||2.57|1.14|0.0089
72348511|NCT01052077|144218828|SUPERIORITY_OR_OTHER||Ratio of Response Rate|1.23||||0.4605|TWO_SIDED|95.0|0.7|2.18|||Cochran-Mantel-Haenszel|CMH general association test controlling for study center.||Week 9||2.18|0.70|0.4605
72348512|NCT01052077|144218828|SUPERIORITY_OR_OTHER||Ratio of Response Rate|1.2||||0.3267|TWO_SIDED|95.0|0.83|1.72|||Cochran-Mantel-Haenszel|CMH general association test controlling for study center.||Week 10||1.72|0.83|0.3267
72348513|NCT01052077|144218828|SUPERIORITY_OR_OTHER||Ratio of Response Rate|1.37||||0.023|TWO_SIDED|95.0|1.05|1.8|||Cochran-Mantel-Haenszel|CMH general association test controlling for study center.||Week 11||1.80|1.05|0.0230
72348514|NCT01052077|144218828|SUPERIORITY_OR_OTHER||Ratio of Response Rate|1.36||||0.0105|TWO_SIDED|95.0|1.08|1.71|||Cochran-Mantel-Haenszel|CMH general association test controlling for study center.||Week 12||1.71|1.08|0.0105
72348515|NCT01052077|144218828|SUPERIORITY_OR_OTHER||Ratio of Response Rate|1.26||||0.0417|TWO_SIDED|95.0|1.01|1.58|||Cochran-Mantel-Haenszel|CMH general association test controlling for study center.||Week 13||1.58|1.01|0.0417
72348516|NCT01052077|144218828|SUPERIORITY_OR_OTHER||Ratio of Response Rate|1.15||||0.2345|TWO_SIDED|95.0|0.91|1.44||CMH general association test controlling for study center.|Cochran-Mantel-Haenszel|Treatment difference = difference in adjusted mean change: brexpiprazole - placebo.||Week 14||1.44|0.91|0.2345
72348517|NCT00042991|144218837|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.0001
72348518|NCT00042991|144218838|SUPERIORITY_OR_OTHER|||||||0.0546||95.0|||||Wilcoxon (Mann-Whitney)|||19 patients had Enhancing tumor at both Baseline and Post-RT time points. Thus, the following test was based on these 19 patients.||||0.0546
72348519|NCT00042991|144218839|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.0001
72348520|NCT00042991|144218840|SUPERIORITY_OR_OTHER|||||||0.18||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.18
72348521|NCT04072887|144218849|SUPERIORITY||Least Squares Mean Difference|0.011|STANDARD_ERROR_OF_MEAN|0.0235||0.628|TWO_SIDED|90.0|-0.027|0.05|||ANCOVA|||||0.050|-0.027|0.628
72348522|NCT04072887|144218849|SUPERIORITY||Least Squares Mean Difference|0.012|STANDARD_ERROR_OF_MEAN|0.0144||0.425|TWO_SIDED|90.0|-0.012|0.035|||ANCOVA|||||0.035|-0.012|0.425
72348523|NCT04072887|144218849|SUPERIORITY||Least Squares Mean Difference|0.013|STANDARD_ERROR_OF_MEAN|0.0174||0.463|TWO_SIDED|90.0|-0.016|0.041|||ANCOVA|||||0.041|-0.016|0.463
72348524|NCT04072887|144218849|SUPERIORITY||Least Squares Mean Difference|0.02|STANDARD_ERROR_OF_MEAN|0.0173||0.244|TWO_SIDED|90.0|-0.008|0.049|||ANCOVA|||||0.049|-0.008|0.244
72348525|NCT04072887|144218849|SUPERIORITY||Least Squares Mean Difference|0.005|STANDARD_ERROR_OF_MEAN|0.0176||0.793|TWO_SIDED|90.0|-0.024|0.034|||ANCOVA|||||0.034|-0.024|0.793
72348526|NCT02697435|144218860|SUPERIORITY||||||<|0.05||||||P-value is calculated.|Mixed Models Analysis|||||||<0.05
72348527|NCT04371666|144218862|OTHER||Least square (LS) Mean Difference|0.083|STANDARD_ERROR_OF_MEAN|0.5494||0.8802|TWO_SIDED|95.0|-1.01|1.176||Threshold for significance at 0.05 level.|Random coefficient model|||||1.176|-1.010|0.8802
72348528|NCT00445770|144218870|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Based on rank transformed data: rank of change = rank baseline+treatment +pooled study center+prior methotrexate use. If overall treatment effect statistically significant, 3 pairwise comparisons conducted, otherwise no further testing was made.|ANCOVA|||It was estimated that with 180 participants per group, there would be 81% power for the overall test. With this sample size and 0.05 (2-sided) type I error, there was 88% power to detect a 1.33 difference for the change of mTSS from baseline to 52 weeks between the etanercept 25 mg twice weekly group and Methotrexate group, assuming that the common standard deviation of the change of mTSS from baseline was 4.||||<0.0001
72348529|NCT00445770|144218870|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model based on rank transformed data: rank of change = rank baseline + treatment + pooled study center + prior methotrexate use.|ANCOVA|||||||<0.0001
72348530|NCT00445770|144218870|NON_INFERIORITY_OR_EQUIVALENCE|An outcome showing that etanercept 10 mg was superior to methotrexate and the presence of numerical difference ≤0.5 mTSS units between etanercept 25 mg and etanercept 10 mg would support non-inferiority for the 2 etanercept treatments.||||||0.2634|TWO_SIDED|||||P-values from ANCOVA model based on rank transformed data: rank of change = rank baseline + treatment + pooled study center + prior methotrexate use.|ANCOVA|||||||0.2634
72348531|NCT00445770|144218871|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model based on rank transformed data: rank of change = rank baseline + treatment + pooled study center + prior methotrexate use.|ANCOVA|||||||<0.0001
72348532|NCT00445770|144218871|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model based on rank transformed data: rank of change = rank baseline + treatment + pooled study center + prior methotrexate use.|ANCOVA|||||||<0.0001
72348533|NCT00445770|144218871|SUPERIORITY_OR_OTHER|||||||0.2248|TWO_SIDED|||||P-values from ANCOVA model based on rank transformed data: rank of change = rank baseline + treatment + pooled study center + prior methotrexate use.|ANCOVA|||||||0.2248
72348534|NCT00445770|144218872|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model based on rank transformed data: rank of change = rank baseline + treatment + pooled study center + prior methotrexate use.|ANCOVA|||Week 24||||<0.0001
72348535|NCT00445770|144218872|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model based on rank transformed data: rank of change = rank baseline + treatment + pooled study center + prior methotrexate use.|ANCOVA|||Week 24||||<0.0001
72348536|NCT00445770|144218872|SUPERIORITY_OR_OTHER|||||||0.726|TWO_SIDED|||||P-values from ANCOVA model based on rank transformed data: rank of change = rank baseline + treatment + pooled study center + prior methotrexate use.|ANCOVA|||Week 24||||0.7260
72348537|NCT00445770|144218872|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model based on rank transformed data: rank of change = rank baseline + treatment + pooled study center + prior methotrexate use.|ANCOVA|||Week 52||||<0.0001
72348538|NCT00445770|144218872|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model based on rank transformed data: rank of change = rank baseline + treatment + pooled study center + prior methotrexate use.|ANCOVA|||Week 52||||<0.0001
72348539|NCT00445770|144218872|SUPERIORITY_OR_OTHER|||||||0.5717|TWO_SIDED|||||P-values from ANCOVA model based on rank transformed data: rank of change = rank baseline + treatment + pooled study center + prior methotrexate use.|ANCOVA|||Week 52||||0.5717
72348540|NCT00445770|144218873|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model based on rank transformed data: rank of change = rank baseline + treatment + pooled study center + prior methotrexate use.|ANCOVA|||Week 24||||<0.0001
72348541|NCT00445770|144218873|SUPERIORITY_OR_OTHER|||||||0.0013|TWO_SIDED|||||P-values from ANCOVA model based on rank transformed data: rank of change = rank baseline + treatment + pooled study center + prior methotrexate use.|ANCOVA|||Week 24||||0.0013
72348542|NCT00445770|144218873|SUPERIORITY_OR_OTHER|||||||0.0186|TWO_SIDED|||||P-values from ANCOVA model based on rank transformed data: rank of change = rank baseline + treatment + pooled study center + prior methotrexate use.|ANCOVA|||Week 24||||0.0186
72348543|NCT00445770|144218873|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model based on rank transformed data: rank of change = rank baseline + treatment + pooled study center + prior methotrexate use.|ANCOVA|||Week 52||||<0.0001
72348544|NCT00445770|144218873|SUPERIORITY_OR_OTHER|||||||0.0006|TWO_SIDED|||||P-values from ANCOVA model based on rank transformed data: rank of change = rank baseline + treatment + pooled study center + prior methotrexate use.|ANCOVA|||Week 52||||0.0006
72348545|NCT00445770|144218873|SUPERIORITY_OR_OTHER|||||||0.1123|TWO_SIDED|||||P-values from ANCOVA model based on rank transformed data: rank of change = rank baseline + treatment + pooled study center + prior methotrexate use.|ANCOVA|||Week 52||||0.1123
72348546|NCT00445770|144218874|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Stratified by pooled study center and prior methotrexate use|Cochran-Mantel-Haenszel|||Week 52 for progression \<=0.5||||<0.0001
72348547|NCT00445770|144218874|SUPERIORITY_OR_OTHER|||||||0.0002|TWO_SIDED|||||Stratified by pooled study center and prior methotrexate use|Cochran-Mantel-Haenszel|||Week 52 for progression \<=0.5||||0.0002
72348548|NCT00445770|144218874|SUPERIORITY_OR_OTHER|||||||0.3022|TWO_SIDED|||||Stratified by pooled study center and prior methotrexate use|Cochran-Mantel-Haenszel|||Week 52 for progression \<=0.5||||0.3022
72348549|NCT00445770|144218874|SUPERIORITY_OR_OTHER|||||||0.0001|TWO_SIDED|||||Stratified by pooled study center and prior methotrexate use|Cochran-Mantel-Haenszel|||Week 52 for progression \<=3.0||||0.0001
72348550|NCT00445770|144218874|SUPERIORITY_OR_OTHER|||||||0.0002|TWO_SIDED|||||Stratified by pooled study center and prior methotrexate use|Cochran-Mantel-Haenszel|||Week 52 for progression \<=3.0||||0.0002
72348551|NCT00445770|144218874|SUPERIORITY_OR_OTHER|||||||0.312|TWO_SIDED|||||Stratified by pooled study center and prior methotrexate use|Cochran-Mantel-Haenszel|||Week 52 for progression \<=3.0||||0.3120
72348552|NCT00445770|144218874|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED|||||Stratified by pooled study center and prior methotrexate use.|Cochran-Mantel-Haenszel|||Week 52 for progression \<=SDD||||0.0010
72348553|NCT00445770|144218874|SUPERIORITY_OR_OTHER|||||||0.0285|TWO_SIDED|||||Stratified by pooled study center and prior methotrexate use|Cochran-Mantel-Haenszel|||Week 52 for progression \<=SDD||||0.0285
72348554|NCT00445770|144218874|SUPERIORITY_OR_OTHER|||||||0.0433|TWO_SIDED|||||Stratified by pooled study center and prior methotrexate use|Cochran-Mantel-Haenszel|||Week 52 for progression \<=SDD||||0.0433
72348555|NCT00445770|144218875|SUPERIORITY_OR_OTHER|||||||0.0032|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 2||||0.0032
72348556|NCT00445770|144218875|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 2||||<0.0001
72348557|NCT00445770|144218875|SUPERIORITY_OR_OTHER|||||||0.1224|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 2||||0.1224
72348558|NCT00445770|144218875|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 4||||<0.0001
72348559|NCT00445770|144218875|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 4||||<0.0001
72348560|NCT00445770|144218875|SUPERIORITY_OR_OTHER|||||||0.8037|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 4||||0.8037
72348561|NCT00445770|144218875|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 8||||<0.0001
72348562|NCT00445770|144218875|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 8||||<0.0001
72348563|NCT00445770|144218875|SUPERIORITY_OR_OTHER|||||||0.5495|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 8||||0.5495
72348564|NCT00445770|144218875|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 12||||<0.0001
72348565|NCT00445770|144218875|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 12||||<0.0001
72348566|NCT00445770|144218875|SUPERIORITY_OR_OTHER|||||||0.4948|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 12||||0.4948
72348567|NCT00445770|144218875|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 16||||<0.0001
72348568|NCT00445770|144218875|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 16||||<0.0001
72348569|NCT00445770|144218875|SUPERIORITY_OR_OTHER|||||||0.4663|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 16||||0.4663
72348570|NCT00445770|144218875|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 20||||<0.0001
72348571|NCT00445770|144218875|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 20||||<0.0001
72348572|NCT00445770|144218875|SUPERIORITY_OR_OTHER|||||||0.9357|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 20||||0.9357
72348573|NCT00445770|144218875|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 24||||<0.0001
72348574|NCT00445770|144218875|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 24||||<0.0001
72348575|NCT00445770|144218875|SUPERIORITY_OR_OTHER|||||||0.7439|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 24||||0.7439
72348576|NCT00445770|144218875|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 32||||<0.0001
72348577|NCT00445770|144218875|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 32||||<0.0001
72348578|NCT00445770|144218875|SUPERIORITY_OR_OTHER|||||||0.8611|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 32||||0.8611
72348579|NCT00445770|144218875|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 40||||<0.0001
72348580|NCT00445770|144218875|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 40||||<0.0001
72348581|NCT00445770|144218875|SUPERIORITY_OR_OTHER|||||||0.6731|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 40||||0.6731
72348582|NCT00445770|144218875|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 48||||<0.0001
72348583|NCT00445770|144218875|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 48||||<0.0001
72348584|NCT00445770|144218875|SUPERIORITY_OR_OTHER|||||||0.2616|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 48||||0.2616
72348585|NCT00445770|144218875|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 52||||<0.0001
72348586|NCT00445770|144218875|SUPERIORITY_OR_OTHER|||||||0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 52||||0.0001
72348587|NCT00445770|144218875|SUPERIORITY_OR_OTHER|||||||0.1158|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 52||||0.1158
72348588|NCT00445770|144218876|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 2||||<0.0001
72348589|NCT00445770|144218876|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 2||||<0.0001
72348590|NCT00445770|144218876|SUPERIORITY_OR_OTHER|||||||0.4237|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 2||||0.4237
72348591|NCT00445770|144218876|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 4||||<0.0001
72348592|NCT00445770|144218876|SUPERIORITY_OR_OTHER|||||||0.0002|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 4||||0.0002
72348593|NCT00445770|144218876|SUPERIORITY_OR_OTHER|||||||0.5738|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 4||||0.5738
72348594|NCT00445770|144218876|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 8||||<0.0001
72348595|NCT00445770|144218876|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 8||||<0.0001
72348596|NCT00445770|144218876|SUPERIORITY_OR_OTHER|||||||0.1606|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 8||||0.1606
72348597|NCT00445770|144218876|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 12||||<0.0001
72348598|NCT00445770|144218876|SUPERIORITY_OR_OTHER|||||||0.0016|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 12||||0.0016
72348599|NCT00445770|144218876|SUPERIORITY_OR_OTHER|||||||0.2412|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 12||||0.2412
72348600|NCT00445770|144218876|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 16||||<0.0001
72348601|NCT00445770|144218876|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 16||||<0.0001
72348602|NCT00445770|144218876|SUPERIORITY_OR_OTHER|||||||0.5882|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 16||||0.5882
72348603|NCT00445770|144218876|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 20||||<0.0001
72348604|NCT00445770|144218876|SUPERIORITY_OR_OTHER|||||||0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 20||||0.0001
72348605|NCT00445770|144218876|SUPERIORITY_OR_OTHER|||||||0.2257|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 20||||0.2257
72348606|NCT00445770|144218876|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 24||||<0.0001
72348607|NCT00445770|144218876|SUPERIORITY_OR_OTHER|||||||0.0003|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 24||||0.0003
72348608|NCT00445770|144218876|SUPERIORITY_OR_OTHER|||||||0.2075|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 24||||0.2075
72348609|NCT00445770|144218876|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 32||||<0.0001
72348610|NCT00445770|144218876|SUPERIORITY_OR_OTHER|||||||0.005|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 32||||0.0050
72348611|NCT00445770|144218876|SUPERIORITY_OR_OTHER|||||||0.0461|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 32||||0.0461
72348612|NCT00445770|144218876|SUPERIORITY_OR_OTHER|||||||0.0002|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 40||||0.0002
72348613|NCT00445770|144218876|SUPERIORITY_OR_OTHER|||||||0.0101|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 40||||0.0101
72348614|NCT00445770|144218876|SUPERIORITY_OR_OTHER|||||||0.2351|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 40||||0.2351
72348615|NCT00445770|144218876|SUPERIORITY_OR_OTHER|||||||0.0002|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 48||||0.0002
72348616|NCT00445770|144218876|SUPERIORITY_OR_OTHER|||||||0.1179|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 48||||0.1179
72348617|NCT00445770|144218876|SUPERIORITY_OR_OTHER|||||||0.0214|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 48||||0.0214
72348618|NCT00445770|144218876|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 52||||<0.0001
72348619|NCT00445770|144218876|SUPERIORITY_OR_OTHER|||||||0.079|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 52||||0.0790
72348620|NCT00445770|144218876|SUPERIORITY_OR_OTHER|||||||0.0168|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 52||||0.0168
72348621|NCT00445770|144218877|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 2||||<0.0001
72348622|NCT00445770|144218877|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 2||||<0.0001
72348623|NCT00445770|144218877|SUPERIORITY_OR_OTHER|||||||0.6337|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 2||||0.6337
72348624|NCT00445770|144218877|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 4||||<0.0001
72348625|NCT00445770|144218877|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 4||||<0.0001
72348626|NCT00445770|144218877|SUPERIORITY_OR_OTHER|||||||0.7407|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 4||||0.7407
72348627|NCT00445770|144218877|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 8||||<0.0001
72348628|NCT00445770|144218877|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 8||||<0.0001
72348629|NCT00445770|144218877|SUPERIORITY_OR_OTHER|||||||0.3473|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 8||||0.3473
72348630|NCT00445770|144218877|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 12||||<0.0001
72348631|NCT00445770|144218877|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 12||||<0.0001
72348632|NCT00445770|144218877|SUPERIORITY_OR_OTHER|||||||0.7529|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 12||||0.7529
72348633|NCT00445770|144218877|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 16||||<0.0001
72348634|NCT00445770|144218877|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 16||||<0.0001
72348635|NCT00445770|144218877|SUPERIORITY_OR_OTHER|||||||0.5216|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 16||||0.5216
72348636|NCT00445770|144218877|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 20||||<0.0001
72348637|NCT00445770|144218877|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 20||||<0.0001
72348638|NCT00445770|144218877|SUPERIORITY_OR_OTHER|||||||0.1078|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 20||||0.1078
72348639|NCT00445770|144218877|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 24||||<0.0001
72348640|NCT00445770|144218877|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 24||||<0.0001
72348641|NCT00445770|144218877|SUPERIORITY_OR_OTHER|||||||0.128|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 24||||0.1280
72348642|NCT00445770|144218877|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 32||||<0.0001
72348643|NCT00445770|144218877|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 32||||<0.0001
72348644|NCT00445770|144218877|SUPERIORITY_OR_OTHER|||||||0.0291|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 32||||0.0291
72348645|NCT00445770|144218877|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 40||||<0.0001
72348646|NCT00445770|144218877|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 40||||<0.0001
72348647|NCT00445770|144218877|SUPERIORITY_OR_OTHER|||||||0.0729|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 40||||0.0729
72348648|NCT00445770|144218877|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 48||||<0.0001
72348649|NCT00445770|144218877|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 48||||<0.0001
72348650|NCT00445770|144218877|SUPERIORITY_OR_OTHER|||||||0.0271|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 48||||0.0271
72348651|NCT00445770|144218877|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 52||||<0.0001
72348652|NCT00445770|144218877|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 52||||<0.0001
72348653|NCT00445770|144218877|SUPERIORITY_OR_OTHER|||||||0.0453|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 52||||0.0453
72348654|NCT00445770|144218878|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 2||||<0.0001
72348655|NCT00445770|144218878|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 2||||<0.0001
72348656|NCT00445770|144218878|SUPERIORITY_OR_OTHER|||||||0.7488|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 2||||0.7488
72348657|NCT00445770|144218878|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 4||||<0.0001
72348658|NCT00445770|144218878|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 4||||<0.0001
72348659|NCT00445770|144218878|SUPERIORITY_OR_OTHER|||||||0.568|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 4||||0.5680
72348660|NCT00445770|144218878|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 8||||<0.0001
72348661|NCT00445770|144218878|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 8||||<0.0001
72348662|NCT00445770|144218878|SUPERIORITY_OR_OTHER|||||||0.9241|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 8||||0.9241
72348663|NCT00445770|144218878|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 12||||<0.0001
72348664|NCT00445770|144218878|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 12||||<0.0001
72348665|NCT00445770|144218878|SUPERIORITY_OR_OTHER|||||||0.7146|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 12||||0.7146
72348666|NCT00445770|144218878|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 16||||<0.0001
72348667|NCT00445770|144218878|SUPERIORITY_OR_OTHER|||||||0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 16||||0.0001
72348668|NCT00445770|144218878|SUPERIORITY_OR_OTHER|||||||0.6574|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 16||||0.6574
72348669|NCT00445770|144218878|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 20||||<0.0001
72348670|NCT00445770|144218878|SUPERIORITY_OR_OTHER|||||||0.0004|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 20||||0.0004
72348671|NCT00445770|144218878|SUPERIORITY_OR_OTHER|||||||0.2936|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 20||||0.2936
72348672|NCT00445770|144218878|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 24||||<0.0001
72348673|NCT00445770|144218878|SUPERIORITY_OR_OTHER|||||||0.0005|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 24||||0.0005
72348674|NCT00445770|144218878|SUPERIORITY_OR_OTHER|||||||0.2179|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 24||||0.2179
72348675|NCT00445770|144218878|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 32||||<0.0001
72348676|NCT00445770|144218878|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 32||||<0.0001
72348677|NCT00445770|144218878|SUPERIORITY_OR_OTHER|||||||0.3704|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 32||||0.3704
72348678|NCT00445770|144218878|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 40||||<0.0001
72348679|NCT00445770|144218878|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 40||||<0.0001
72348680|NCT00445770|144218878|SUPERIORITY_OR_OTHER|||||||0.8047|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 40||||0.8047
72348681|NCT00445770|144218878|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 48||||<0.0001
72348682|NCT00445770|144218878|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 48||||<0.0001
72348683|NCT00445770|144218878|SUPERIORITY_OR_OTHER|||||||0.5277|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 48||||0.5277
72348684|NCT00445770|144218878|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 52||||<0.0001
72348685|NCT00445770|144218878|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 52||||<0.0001
72348686|NCT00445770|144218878|SUPERIORITY_OR_OTHER|||||||0.9371|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 52||||0.9371
72348687|NCT00445770|144218879|SUPERIORITY_OR_OTHER|||||||0.0027|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 2||||0.0027
72348688|NCT00445770|144218879|SUPERIORITY_OR_OTHER|||||||0.0015|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 2||||0.0015
72348689|NCT00445770|144218879|SUPERIORITY_OR_OTHER|||||||0.8875|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 2||||0.8875
72348690|NCT00445770|144218879|SUPERIORITY_OR_OTHER|||||||0.0015|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 4||||0.0015
72348691|NCT00445770|144218879|SUPERIORITY_OR_OTHER|||||||0.0011|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 4||||0.0011
72348692|NCT00445770|144218879|SUPERIORITY_OR_OTHER|||||||0.9694|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 4||||0.9694
72348693|NCT00445770|144218879|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 8||||0.0020
72348694|NCT00445770|144218879|SUPERIORITY_OR_OTHER|||||||0.0005|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 8||||0.0005
72348695|NCT00445770|144218879|SUPERIORITY_OR_OTHER|||||||0.7271|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 8||||0.7271
72348696|NCT00445770|144218879|SUPERIORITY_OR_OTHER|||||||0.0235|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 12||||0.0235
72348697|NCT00445770|144218879|SUPERIORITY_OR_OTHER|||||||0.0061|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 12||||0.0061
72348698|NCT00445770|144218879|SUPERIORITY_OR_OTHER|||||||0.6427|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 12||||0.6427
72348699|NCT00445770|144218879|SUPERIORITY_OR_OTHER|||||||0.0036|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 16||||0.0036
72348700|NCT00445770|144218879|SUPERIORITY_OR_OTHER|||||||0.0029|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 16||||0.0029
72348701|NCT00445770|144218879|SUPERIORITY_OR_OTHER|||||||0.9713|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 16||||0.9713
72348702|NCT00445770|144218879|SUPERIORITY_OR_OTHER|||||||0.006|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 20||||0.0060
72348703|NCT00445770|144218879|SUPERIORITY_OR_OTHER|||||||0.006|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 20||||0.0060
72348704|NCT00445770|144218879|SUPERIORITY_OR_OTHER|||||||0.9762|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 20||||0.9762
72348705|NCT00445770|144218879|SUPERIORITY_OR_OTHER|||||||0.0554|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 24||||0.0554
72348706|NCT00445770|144218879|SUPERIORITY_OR_OTHER|||||||0.0181|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 24||||0.0181
72348707|NCT00445770|144218879|SUPERIORITY_OR_OTHER|||||||0.6642|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 24||||0.6642
72348708|NCT00445770|144218879|SUPERIORITY_OR_OTHER|||||||0.0073|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 32||||0.0073
72348709|NCT00445770|144218879|SUPERIORITY_OR_OTHER|||||||0.029|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 32||||0.0290
72348710|NCT00445770|144218879|SUPERIORITY_OR_OTHER|||||||0.5919|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 32||||0.5919
72348711|NCT00445770|144218879|SUPERIORITY_OR_OTHER|||||||0.0371|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 40||||0.0371
72348712|NCT00445770|144218879|SUPERIORITY_OR_OTHER|||||||0.0346|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 40||||0.0346
72348713|NCT00445770|144218879|SUPERIORITY_OR_OTHER|||||||0.9955|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 40||||0.9955
72348714|NCT00445770|144218879|SUPERIORITY_OR_OTHER|||||||0.0187|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 48||||0.0187
72348715|NCT00445770|144218879|SUPERIORITY_OR_OTHER|||||||0.0645|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 48||||0.0645
72348716|NCT00445770|144218879|SUPERIORITY_OR_OTHER|||||||0.592|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 48||||0.5920
72348717|NCT00445770|144218879|SUPERIORITY_OR_OTHER|||||||0.0095|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 52||||0.0095
72348718|NCT00445770|144218879|SUPERIORITY_OR_OTHER|||||||0.2112|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 52||||0.2112
72348719|NCT00445770|144218879|SUPERIORITY_OR_OTHER|||||||0.1649|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 52||||0.1649
72348720|NCT00445770|144218880|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 2||||<0.0001
72348721|NCT00445770|144218880|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 2||||<0.0001
72348722|NCT00445770|144218880|SUPERIORITY_OR_OTHER|||||||0.8972|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 2||||0.8972
72348723|NCT00445770|144218880|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 4||||<0.0001
72348724|NCT00445770|144218880|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 4||||<0.0001
72348725|NCT00445770|144218880|SUPERIORITY_OR_OTHER|||||||0.3736|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 4||||0.3736
72348726|NCT00445770|144218880|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 8||||<0.0001
72348727|NCT00445770|144218880|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 8||||<0.0001
72348728|NCT00445770|144218880|SUPERIORITY_OR_OTHER|||||||0.9324|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 8||||0.9324
72348729|NCT00445770|144218880|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 12||||<0.0001
72348730|NCT00445770|144218880|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 12||||<0.0001
72348731|NCT00445770|144218880|SUPERIORITY_OR_OTHER|||||||0.8982|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 12||||0.8982
72348732|NCT00445770|144218880|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 16||||<0.0001
72348733|NCT00445770|144218880|SUPERIORITY_OR_OTHER|||||||0.0007|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 16||||0.0007
72348734|NCT00445770|144218880|SUPERIORITY_OR_OTHER|||||||0.318|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 16||||0.3180
72348735|NCT00445770|144218880|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 20||||<0.0001
72348736|NCT00445770|144218880|SUPERIORITY_OR_OTHER|||||||0.0011|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 20||||0.0011
72348737|NCT00445770|144218880|SUPERIORITY_OR_OTHER|||||||0.3302|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 20||||0.3302
72348738|NCT00445770|144218880|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 24||||<0.0001
72348739|NCT00445770|144218880|SUPERIORITY_OR_OTHER|||||||0.0002|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 24||||0.0002
72348740|NCT00445770|144218880|SUPERIORITY_OR_OTHER|||||||0.6563|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 24||||0.6563
72348741|NCT00445770|144218880|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 32||||<0.0001
72348742|NCT00445770|144218880|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 32||||<0.0001
72348743|NCT00445770|144218880|SUPERIORITY_OR_OTHER|||||||0.8894|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 32||||0.8894
72348744|NCT00445770|144218880|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 40||||<0.0001
72348745|NCT00445770|144218880|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 40||||<0.0001
72348746|NCT00445770|144218880|SUPERIORITY_OR_OTHER|||||||0.7826|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 40||||0.7826
72348747|NCT00445770|144218880|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 48||||<0.0001
72348748|NCT00445770|144218880|SUPERIORITY_OR_OTHER|||||||0.0003|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 48||||0.0003
72348749|NCT00445770|144218880|SUPERIORITY_OR_OTHER|||||||0.5343|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 48||||0.5343
72348750|NCT00445770|144218880|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 52||||<0.0001
72348751|NCT00445770|144218880|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 52||||<0.0001
72348752|NCT00445770|144218880|SUPERIORITY_OR_OTHER|||||||0.9313|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 52||||0.9313
72348753|NCT00445770|144218881|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 2||||<0.0001
72348754|NCT00445770|144218881|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 2||||<0.0001
72348755|NCT00445770|144218881|SUPERIORITY_OR_OTHER|||||||0.8044|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 2||||0.8044
72348756|NCT00445770|144218881|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 4||||<0.0001
72348757|NCT00445770|144218881|SUPERIORITY_OR_OTHER|||||||0.0003|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 4||||0.0003
72348758|NCT00445770|144218881|SUPERIORITY_OR_OTHER|||||||0.4652|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 4||||0.4652
72348759|NCT00445770|144218881|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 8||||<0.0001
72348760|NCT00445770|144218881|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 8||||<0.0001
72348761|NCT00445770|144218881|SUPERIORITY_OR_OTHER|||||||0.5612|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 8||||0.5612
72348762|NCT00445770|144218881|SUPERIORITY_OR_OTHER|||||||0.0002|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 12||||0.0002
72348763|NCT00445770|144218881|SUPERIORITY_OR_OTHER|||||||0.0002|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 12||||0.0002
72348764|NCT00445770|144218881|SUPERIORITY_OR_OTHER|||||||0.9749|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 12||||0.9749
72348765|NCT00445770|144218881|SUPERIORITY_OR_OTHER|||||||0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 16||||0.0001
72348766|NCT00445770|144218881|SUPERIORITY_OR_OTHER|||||||0.0004|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 16||||0.0004
72348767|NCT00445770|144218881|SUPERIORITY_OR_OTHER|||||||0.729|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 16||||0.7290
72348768|NCT00445770|144218881|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 20||||<0.0001
72348769|NCT00445770|144218881|SUPERIORITY_OR_OTHER|||||||0.0003|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 20||||0.0003
72348770|NCT00445770|144218881|SUPERIORITY_OR_OTHER|||||||0.5004|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 20||||0.5004
72348771|NCT00445770|144218881|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 24||||<0.0001
72348772|NCT00445770|144218881|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 24||||<0.0001
72348773|NCT00445770|144218881|SUPERIORITY_OR_OTHER|||||||0.5727|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 24||||0.5727
72348774|NCT00445770|144218881|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 32||||<0.0001
72348775|NCT00445770|144218881|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 32||||<0.0001
72348776|NCT00445770|144218881|SUPERIORITY_OR_OTHER|||||||0.6713|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 32||||0.6713
72348777|NCT00445770|144218881|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 40||||<0.0001
72348778|NCT00445770|144218881|SUPERIORITY_OR_OTHER|||||||0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 40||||0.0001
72348779|NCT00445770|144218881|SUPERIORITY_OR_OTHER|||||||0.7663|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 40||||0.7663
72348780|NCT00445770|144218881|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 48||||<0.0001
72348781|NCT00445770|144218881|SUPERIORITY_OR_OTHER|||||||0.0002|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 48||||0.0002
72348782|NCT00445770|144218881|SUPERIORITY_OR_OTHER|||||||0.7073|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 48||||0.7073
72348783|NCT00445770|144218881|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 52||||<0.0001
72348784|NCT00445770|144218881|SUPERIORITY_OR_OTHER|||||||0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 52||||0.0001
72348785|NCT00445770|144218881|SUPERIORITY_OR_OTHER|||||||0.7973|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 52||||0.7973
72348786|NCT00445770|144218882|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 2||||<0.0001
72348787|NCT00445770|144218882|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 2||||<0.0001
72348788|NCT00445770|144218882|SUPERIORITY_OR_OTHER|||||||0.1053|TWO_SIDED||||||ANCOVA|P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 2||||0.1053
72348789|NCT00445770|144218882|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 4||||<0.0001
72348790|NCT00445770|144218882|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 4||||<0.0001
72348791|NCT00445770|144218882|SUPERIORITY_OR_OTHER|||||||0.0144|TWO_SIDED||||||ANCOVA|P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 4||||0.0144
72348792|NCT00445770|144218882|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 8||||<0.0001
72348793|NCT00445770|144218882|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 8||||<0.0001
72348794|NCT00445770|144218882|SUPERIORITY_OR_OTHER|||||||0.1851|TWO_SIDED||||||ANCOVA|P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 8||||0.1851
72348795|NCT00445770|144218882|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 12||||<0.0001
72348796|NCT00445770|144218882|SUPERIORITY_OR_OTHER|||||||0.0001|TWO_SIDED||||||ANCOVA|P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 12||||0.0001
72348797|NCT00445770|144218882|SUPERIORITY_OR_OTHER|||||||0.2883|TWO_SIDED||||||ANCOVA|P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 12||||0.2883
72348798|NCT00445770|144218882|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 16||||<0.0001
72348799|NCT00445770|144218882|SUPERIORITY_OR_OTHER|||||||0.0007|TWO_SIDED||||||ANCOVA|P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 16||||0.0007
72348800|NCT00445770|144218882|SUPERIORITY_OR_OTHER|||||||0.2221|TWO_SIDED||||||ANCOVA|P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 16||||0.2221
72348801|NCT00445770|144218882|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 20||||<0.0001
72348802|NCT00445770|144218882|SUPERIORITY_OR_OTHER|||||||0.0147|TWO_SIDED||||||ANCOVA|P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 20||||0.0147
72348803|NCT00445770|144218882|SUPERIORITY_OR_OTHER|||||||0.0201|TWO_SIDED||||||ANCOVA|P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 20||||0.0201
72348804|NCT00445770|144218882|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 24||||<0.0001
72348805|NCT00445770|144218882|SUPERIORITY_OR_OTHER|||||||0.0036|TWO_SIDED||||||ANCOVA|P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 24||||0.0036
72348806|NCT00445770|144218882|SUPERIORITY_OR_OTHER|||||||0.0789|TWO_SIDED||||||ANCOVA|P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 24||||0.0789
72348807|NCT00445770|144218882|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 32||||<0.0001
72348808|NCT00445770|144218882|SUPERIORITY_OR_OTHER|||||||0.0008|TWO_SIDED||||||ANCOVA|P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 32||||0.0008
72348809|NCT00445770|144218882|SUPERIORITY_OR_OTHER|||||||0.1903|TWO_SIDED||||||ANCOVA|P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 32||||0.1903
72348810|NCT00445770|144218882|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 40||||<0.0001
72348811|NCT00445770|144218882|SUPERIORITY_OR_OTHER|||||||0.0048|TWO_SIDED||||||ANCOVA|P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 40||||0.0048
72348812|NCT00445770|144218882|SUPERIORITY_OR_OTHER|||||||0.1059|TWO_SIDED||||||ANCOVA|P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 40||||0.1059
72348813|NCT00445770|144218882|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 48||||<0.0001
72348814|NCT00445770|144218882|SUPERIORITY_OR_OTHER|||||||0.0018|TWO_SIDED||||||ANCOVA|P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 48||||0.0018
72348815|NCT00445770|144218882|SUPERIORITY_OR_OTHER|||||||0.2589|TWO_SIDED||||||ANCOVA|P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 48||||0.2589
72348816|NCT00445770|144218882|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 52||||<0.0001
72348817|NCT00445770|144218882|SUPERIORITY_OR_OTHER|||||||0.004|TWO_SIDED||||||ANCOVA|P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 52||||0.0040
72348818|NCT00445770|144218882|SUPERIORITY_OR_OTHER|||||||0.2326|TWO_SIDED||||||ANCOVA|P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 52||||0.2326
72348819|NCT00445770|144218883|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 2||||<0.0001
72348820|NCT00445770|144218883|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 2||||<0.0001
72348821|NCT00445770|144218883|SUPERIORITY_OR_OTHER|||||||0.4751|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 2||||0.4751
72348822|NCT00445770|144218883|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 4||||<0.0001
72348823|NCT00445770|144218883|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 4||||<0.0001
72348824|NCT00445770|144218883|SUPERIORITY_OR_OTHER|||||||0.4653|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 4||||0.4653
72348825|NCT00445770|144218883|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 8||||<0.0001
72348826|NCT00445770|144218883|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 8||||<0.0001
72348827|NCT00445770|144218883|SUPERIORITY_OR_OTHER|||||||0.7953|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 8||||0.7953
72348828|NCT00445770|144218883|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 12||||<0.0001
72348829|NCT00445770|144218883|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 12||||<0.0001
72348830|NCT00445770|144218883|SUPERIORITY_OR_OTHER|||||||0.0848|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 12||||0.0848
72348831|NCT00445770|144218883|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 16||||<0.0001
72348832|NCT00445770|144218883|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 16||||<0.0001
72348833|NCT00445770|144218883|SUPERIORITY_OR_OTHER|||||||0.6112|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 16||||0.6112
72348834|NCT00445770|144218883|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 20||||<0.0001
72348835|NCT00445770|144218883|SUPERIORITY_OR_OTHER|||||||0.0002|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 20||||0.0002
72348836|NCT00445770|144218883|SUPERIORITY_OR_OTHER|||||||0.3671|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 20||||0.3671
72348837|NCT00445770|144218883|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 24||||<0.0001
72348838|NCT00445770|144218883|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 24||||<0.0001
72348839|NCT00445770|144218883|SUPERIORITY_OR_OTHER|||||||0.7618|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 24||||0.7618
72348840|NCT00445770|144218883|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 32||||<0.0001
72348841|NCT00445770|144218883|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 32||||<0.0001
72348842|NCT00445770|144218883|SUPERIORITY_OR_OTHER|||||||0.4358|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 32||||0.4358
72348843|NCT00445770|144218883|SUPERIORITY_OR_OTHER|||||||0.0008|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 40||||0.0008
72429100|NCT01671748|144369110|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.4||||0.565|TWO_SIDED|95.0|-33.4|18.6||ANCOVA was used to analyse differences between the NLFU+SOC and SOC arms of the primary endpoint, percentage change in wound area from baseline (week 5) to final visit (week 13). Patients' baseline (week 5) wound area was used as the covariate.|ANCOVA|||The study was powered to detect a difference in the change in wound area of 20% between the two arms with a two sided significance level and power of 90%. A standard deviation of 17.5% came from published literature. A minimum of 17 patients in each arm was required.||18.6|-33.4|0.565
72348844|NCT00445770|144218883|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 40||||<0.0001
72348845|NCT00445770|144218883|SUPERIORITY_OR_OTHER|||||||0.6267|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 40||||0.6267
72348846|NCT00445770|144218883|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 48||||<0.0001
72348847|NCT00445770|144218883|SUPERIORITY_OR_OTHER|||||||0.0004|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 48||||0.0004
72348848|NCT00445770|144218883|SUPERIORITY_OR_OTHER|||||||0.3564|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 48||||0.3564
72348849|NCT00445770|144218883|SUPERIORITY_OR_OTHER|||||||0.0007|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 52||||0.0007
72348850|NCT00445770|144218883|SUPERIORITY_OR_OTHER|||||||0.0035|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 52||||0.0035
72348851|NCT00445770|144218883|SUPERIORITY_OR_OTHER|||||||0.4749|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 52||||0.4749
72348852|NCT00445770|144218884|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 2||||<0.0001
72348853|NCT00445770|144218884|SUPERIORITY_OR_OTHER|||||||0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 2||||0.0001
72348854|NCT00445770|144218884|SUPERIORITY_OR_OTHER|||||||0.4376|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 2||||0.4376
72348855|NCT00445770|144218884|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 4||||<0.0001
72348856|NCT00445770|144218884|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 4||||<0.0001
72348857|NCT00445770|144218884|SUPERIORITY_OR_OTHER|||||||0.3947|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 4||||0.3947
72348858|NCT00445770|144218884|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 8||||<0.0001
72348859|NCT00445770|144218884|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 8||||<0.0001
72348860|NCT00445770|144218884|SUPERIORITY_OR_OTHER|||||||0.7378|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 8||||0.7378
72348861|NCT00445770|144218884|SUPERIORITY_OR_OTHER|||||||0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 12||||0.0001
72348862|NCT00445770|144218884|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 12||||<0.0001
72348863|NCT00445770|144218884|SUPERIORITY_OR_OTHER|||||||0.568|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 12||||0.5680
72429101|NCT01671748|144369111|SUPERIORITY_OR_OTHER|||||||0.49|TWO_SIDED||||||ANCOVA|||ANCOVA was used for change in HRQoL from week 1 to week 13 (with week 1 HRQoL score as the covariate).||||0.490
72429102|NCT01671748|144369112|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-9.08||||0.078|TWO_SIDED|95.0|-19.23|1.06|||ANCOVA|||ANCOVA was used for change in pain score (VAS) from week 5 to week 13 (covariate was baseline pain score).||1.06|-19.23|0.078
72348864|NCT00445770|144218884|SUPERIORITY_OR_OTHER|||||||0.0003|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 16||||0.0003
72348865|NCT00445770|144218884|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 16||||<0.0001
72348866|NCT00445770|144218884|SUPERIORITY_OR_OTHER|||||||0.3978|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 16||||0.3978
72348867|NCT00445770|144218884|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 20||||<0.0001
72348868|NCT00445770|144218884|SUPERIORITY_OR_OTHER|||||||0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 20||||0.0001
72348869|NCT00445770|144218884|SUPERIORITY_OR_OTHER|||||||0.7229|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 20||||0.7229
72348870|NCT00445770|144218884|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 24||||<0.0001
72348871|NCT00445770|144218884|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 24||||<0.0001
72348872|NCT00445770|144218884|SUPERIORITY_OR_OTHER|||||||0.7236|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 24||||0.7236
72348873|NCT00445770|144218884|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 32||||<0.0001
72348874|NCT00445770|144218884|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 32||||<0.0001
72348875|NCT00445770|144218884|SUPERIORITY_OR_OTHER|||||||0.9719|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 32||||0.9719
72348876|NCT00445770|144218884|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 40||||<0.0001
72348877|NCT00445770|144218884|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 40||||<0.0001
72348878|NCT00445770|144218884|SUPERIORITY_OR_OTHER|||||||0.9349|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 40||||0.9349
72348879|NCT00445770|144218884|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 48||||<0.0001
72429103|NCT01671748|144369113|SUPERIORITY_OR_OTHER|||||||0.346|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Change in number of infections were not normally distributed and differences between the arms were tested using the non-parametric Mann-Whitney U test.||||0.346
72348880|NCT00445770|144218884|SUPERIORITY_OR_OTHER|||||||0.0002|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 48||||0.0002
72348881|NCT00445770|144218884|SUPERIORITY_OR_OTHER|||||||0.7226|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 48||||0.7226
72348882|NCT00445770|144218884|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 52||||<0.0001
72348883|NCT00445770|144218884|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 52||||<0.0001
72348884|NCT00445770|144218884|SUPERIORITY_OR_OTHER|||||||0.5512|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 52||||0.5512
72348885|NCT00445770|144218885|SUPERIORITY_OR_OTHER|||||||0.0162|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 2||||0.0162
72348886|NCT00445770|144218885|SUPERIORITY_OR_OTHER|||||||0.0035|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 2||||0.0035
72348887|NCT00445770|144218885|SUPERIORITY_OR_OTHER|||||||0.8928|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 2||||0.8928
72348888|NCT00445770|144218885|SUPERIORITY_OR_OTHER|||||||0.0009|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 4||||0.0009
72348889|NCT00445770|144218885|SUPERIORITY_OR_OTHER|||||||0.0007|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 4||||0.0007
72348890|NCT00445770|144218885|SUPERIORITY_OR_OTHER|||||||0.6348|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 4||||0.6348
72348891|NCT00445770|144218885|SUPERIORITY_OR_OTHER|||||||0.0026|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 8||||0.0026
72348892|NCT00445770|144218885|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 8||||<0.0001
72348893|NCT00445770|144218885|SUPERIORITY_OR_OTHER|||||||0.4629|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 8||||0.4629
72348894|NCT00445770|144218885|SUPERIORITY_OR_OTHER|||||||0.0841|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 12||||0.0841
72348895|NCT00445770|144218885|SUPERIORITY_OR_OTHER|||||||0.0007|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 12||||0.0007
72348896|NCT00445770|144218885|SUPERIORITY_OR_OTHER|||||||0.1957|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 12||||0.1957
72348897|NCT00445770|144218885|SUPERIORITY_OR_OTHER|||||||0.0093|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 16||||0.0093
72348898|NCT00445770|144218885|SUPERIORITY_OR_OTHER|||||||0.0326|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 16||||0.0326
72348899|NCT00445770|144218885|SUPERIORITY_OR_OTHER|||||||0.7426|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 16||||0.7426
72348900|NCT00445770|144218885|SUPERIORITY_OR_OTHER|||||||0.0013|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 20||||0.0013
72348901|NCT00445770|144218885|SUPERIORITY_OR_OTHER|||||||0.0015|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 20||||0.0015
72348902|NCT00445770|144218885|SUPERIORITY_OR_OTHER|||||||0.6552|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 20||||0.6552
72348903|NCT00445770|144218885|SUPERIORITY_OR_OTHER|||||||0.0005|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 24||||0.0005
72348904|NCT00445770|144218885|SUPERIORITY_OR_OTHER|||||||0.0004|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 24||||0.0004
72348905|NCT00445770|144218885|SUPERIORITY_OR_OTHER|||||||0.6294|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 24||||0.6294
72348906|NCT00445770|144218885|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 32||||<0.0001
72348907|NCT00445770|144218885|SUPERIORITY_OR_OTHER|||||||0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 32||||0.0001
72348908|NCT00445770|144218885|SUPERIORITY_OR_OTHER|||||||0.4652|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 32||||0.4652
72348909|NCT00445770|144218885|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 40||||<0.0001
72348910|NCT00445770|144218885|SUPERIORITY_OR_OTHER|||||||0.0002|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 40||||0.0002
72348911|NCT00445770|144218885|SUPERIORITY_OR_OTHER|||||||0.2233|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 40||||0.2233
72348912|NCT00445770|144218885|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 48||||<0.0001
72348913|NCT00445770|144218885|SUPERIORITY_OR_OTHER|||||||0.0003|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 48||||0.0003
72348914|NCT00445770|144218885|SUPERIORITY_OR_OTHER|||||||0.6772|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 48||||0.6772
72348915|NCT00445770|144218885|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 52||||<0.0001
72348916|NCT00445770|144218885|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 52||||<0.0001
72348917|NCT00445770|144218885|SUPERIORITY_OR_OTHER|||||||0.616|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 52||||0.6160
72348918|NCT00445770|144218886|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 2||||<0.0001
72348919|NCT00445770|144218886|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 2||||<0.0001
72348920|NCT00445770|144218886|SUPERIORITY_OR_OTHER|||||||0.4929|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 2||||0.4929
72348921|NCT00445770|144218886|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 4||||<0.0001
72348922|NCT00445770|144218886|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 4||||<0.0001
72348923|NCT00445770|144218886|SUPERIORITY_OR_OTHER|||||||0.9693|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 4||||0.9693
72348924|NCT00445770|144218886|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 8||||<0.0001
72348925|NCT00445770|144218886|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 8||||<0.0001
72348926|NCT00445770|144218886|SUPERIORITY_OR_OTHER|||||||0.4139|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 8||||0.4139
72348927|NCT00445770|144218886|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 12||||<0.0001
72348928|NCT00445770|144218886|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 12||||<0.0001
72348929|NCT00445770|144218886|SUPERIORITY_OR_OTHER|||||||0.8905|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 12||||0.8905
72348930|NCT00445770|144218886|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 16||||<0.0001
72348931|NCT00445770|144218886|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 16||||<0.0001
72348932|NCT00445770|144218886|SUPERIORITY_OR_OTHER|||||||0.6877|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 16||||0.6877
72348933|NCT00445770|144218886|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 20||||<0.0001
72348934|NCT00445770|144218886|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 20||||<0.0001
72348935|NCT00445770|144218886|SUPERIORITY_OR_OTHER|||||||0.4511|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 20||||0.4511
72348936|NCT00445770|144218886|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 24||||<0.0001
72348937|NCT00445770|144218886|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 24||||<0.0001
72348938|NCT00445770|144218886|SUPERIORITY_OR_OTHER|||||||0.2786|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 24||||0.2786
72348939|NCT00445770|144218886|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 32||||<0.0001
72429104|NCT01671748|144369115|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9||||0.618|TWO_SIDED|95.0|-4.7|2.9|||ANCOVA|Patients' baseline (week 5) wound area was used as the covariate.||||2.9|-4.7|0.618
72348940|NCT00445770|144218886|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 32||||<0.0001
72348941|NCT00445770|144218886|SUPERIORITY_OR_OTHER|||||||0.123|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 32||||0.1230
72348942|NCT00445770|144218886|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 40||||<0.0001
72348943|NCT00445770|144218886|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 40||||<0.0001
72348944|NCT00445770|144218886|SUPERIORITY_OR_OTHER|||||||0.5061|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 40||||0.5061
72348945|NCT00445770|144218886|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 48||||<0.0001
72348946|NCT00445770|144218886|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 48||||<0.0001
72348947|NCT00445770|144218886|SUPERIORITY_OR_OTHER|||||||0.1354|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 48||||0.1354
72348948|NCT00445770|144218886|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 52||||<0.0001
72348949|NCT00445770|144218886|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 52||||<0.0001
72348950|NCT00445770|144218886|SUPERIORITY_OR_OTHER|||||||0.1734|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 52||||0.1734
72429105|NCT02555371|144369128|SUPERIORITY||Hazard Ratio (HR)|0.62||||0.004|TWO_SIDED|95.0|0.45|0.86|||Cox Proportional Hazards Model||Treatment comparison between mepolizumab 100 mg SC and placebo using hazards ratio and 95% confidence interval has been presented.|||0.86|0.45|0.004
72348951|NCT00445770|144218887|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 2||||<0.0001
72348952|NCT00445770|144218887|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 2||||<0.0001
72348953|NCT00445770|144218887|SUPERIORITY_OR_OTHER|||||||0.6417|TWO_SIDED|||||p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 2||||0.6417
72348954|NCT00445770|144218887|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 4||||<0.0001
72348955|NCT00445770|144218887|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 4||||<0.0001
72348956|NCT00445770|144218887|SUPERIORITY_OR_OTHER|||||||0.4698|TWO_SIDED|||||p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 4||||0.4698
72348957|NCT00445770|144218887|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 8||||<0.0001
72348958|NCT00445770|144218887|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 8||||<0.0001
72348959|NCT00445770|144218887|SUPERIORITY_OR_OTHER|||||||0.1214|TWO_SIDED|||||p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 8||||0.1214
72348960|NCT00445770|144218887|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 12||||<0.0001
72348961|NCT00445770|144218887|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 12||||<0.0001
72348962|NCT00445770|144218887|SUPERIORITY_OR_OTHER|||||||0.4654|TWO_SIDED|||||p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 12||||0.4654
72348963|NCT00445770|144218887|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 16||||<0.0001
72348964|NCT00445770|144218887|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 16||||<0.0001
72429106|NCT02555371|144369129|SUPERIORITY||Ratio|0.19|||<|0.001|TWO_SIDED|95.0|0.15|0.24|||Mixed model repeated measures||Treatment comparison between mepolizumab 100 mg SC and placebo using ratio of mepolizumab to placebo and its 95% confidence interval at Week 12 has been presented.|||0.24|0.15|<0.001
72348965|NCT00445770|144218887|SUPERIORITY_OR_OTHER|||||||0.4006|TWO_SIDED|||||p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 16||||0.4006
72348966|NCT00445770|144218887|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 20||||<0.0001
72348967|NCT00445770|144218887|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 20||||<0.0001
72348968|NCT00445770|144218887|SUPERIORITY_OR_OTHER|||||||0.1636|TWO_SIDED|||||p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 20||||0.1636
72348969|NCT00445770|144218887|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 24||||<0.0001
72348970|NCT00445770|144218887|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 24||||<0.0001
72348971|NCT00445770|144218887|SUPERIORITY_OR_OTHER|||||||0.2635|TWO_SIDED|||||p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 24||||0.2635
72348972|NCT00445770|144218887|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 32||||<0.0001
72348973|NCT00445770|144218887|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 32||||<0.0001
72348974|NCT00445770|144218887|SUPERIORITY_OR_OTHER|||||||0.0965|TWO_SIDED|||||p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 32||||0.0965
72348975|NCT00445770|144218887|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 40||||<0.0001
72348976|NCT00445770|144218887|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 40||||<0.0001
72348977|NCT00445770|144218887|SUPERIORITY_OR_OTHER|||||||0.4437|TWO_SIDED|||||p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 40||||0.4437
72348978|NCT00445770|144218887|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 48||||<0.0001
72348979|NCT00445770|144218887|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 48||||<0.0001
72348980|NCT00445770|144218887|SUPERIORITY_OR_OTHER|||||||0.1663|TWO_SIDED|||||p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 48||||0.1663
72348981|NCT00445770|144218887|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 52||||<0.0001
72348982|NCT00445770|144218887|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 52||||<0.0001
72348983|NCT00445770|144218887|SUPERIORITY_OR_OTHER|||||||0.1049|TWO_SIDED|||||p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 52||||0.1049
72348984|NCT00445770|144218888|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment||Week 2||||<0.0001
72348985|NCT00445770|144218888|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment||Week 2||||<0.0001
72348986|NCT00445770|144218888|SUPERIORITY_OR_OTHER|||||||0.0442|TWO_SIDED||||||ANCOVA|P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment||Week 2||||0.0442
72348987|NCT00445770|144218888|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 4||||<0.0001
72348988|NCT00445770|144218888|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 4||||<0.0001
72348989|NCT00445770|144218888|SUPERIORITY_OR_OTHER|||||||0.0681|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 4||||0.0681
72348990|NCT00445770|144218888|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 8||||<0.0001
72348991|NCT00445770|144218888|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 8||||<0.0001
72348992|NCT00445770|144218888|SUPERIORITY_OR_OTHER|||||||0.0966|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 8||||0.0966
72348993|NCT00445770|144218888|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 12||||<0.0001
72348994|NCT00445770|144218888|SUPERIORITY_OR_OTHER|||||||0.0006|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 12||||0.0006
72348995|NCT00445770|144218888|SUPERIORITY_OR_OTHER|||||||0.1242|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 12||||0.1242
72348996|NCT00445770|144218888|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 16||||<0.0001
72348997|NCT00445770|144218888|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 16||||<0.001
72348998|NCT00445770|144218888|SUPERIORITY_OR_OTHER|||||||0.1521|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 16||||0.1521
72348999|NCT00445770|144218888|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 20||||<0.0001
72349000|NCT00445770|144218888|SUPERIORITY_OR_OTHER|||||||0.007|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 20||||0.0070
72349001|NCT00445770|144218888|SUPERIORITY_OR_OTHER|||||||0.014|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 20||||0.0140
72349002|NCT00445770|144218888|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 24||||<0.0001
72349003|NCT00445770|144218888|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 24||||<0.0001
72349004|NCT00445770|144218888|SUPERIORITY_OR_OTHER|||||||0.0815|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 24||||0.0815
72349005|NCT00445770|144218888|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 32||||<0.0001
72349006|NCT00445770|144218888|SUPERIORITY_OR_OTHER|||||||0.0002|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 32||||0.0002
72349007|NCT00445770|144218888|SUPERIORITY_OR_OTHER|||||||0.0886|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 32||||0.0886
72349008|NCT00445770|144218888|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 40||||<0.0001
72349009|NCT00445770|144218888|SUPERIORITY_OR_OTHER|||||||0.0003|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 40||||0.0003
72349010|NCT00445770|144218888|SUPERIORITY_OR_OTHER|||||||0.1488|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 40||||0.1488
72349011|NCT00445770|144218888|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 48||||<0.0001
72349012|NCT00445770|144218888|SUPERIORITY_OR_OTHER|||||||0.0006|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 48||||0.0006
72349013|NCT00445770|144218888|SUPERIORITY_OR_OTHER|||||||0.0979|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 48||||0.0979
72349014|NCT00445770|144218888|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 52||||<0.0001
72349015|NCT00445770|144218888|SUPERIORITY_OR_OTHER|||||||0.0001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 52||||0.0001
72349016|NCT00445770|144218888|SUPERIORITY_OR_OTHER|||||||0.174|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 52||||0.1740
72349017|NCT00445770|144218889|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior Methotrexate use + treatment.||Week 2||||<0.0001
72349018|NCT00445770|144218889|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior MTX use + treatment.||Week 2||||<0.0001
72349019|NCT00445770|144218889|SUPERIORITY_OR_OTHER|||||||0.0274|TWO_SIDED|||||p-Values from ANCOVA model: change = baseline + pooled study center + prior MTX use + treatment.|ANCOVA|||Week 2||||0.0274
72349020|NCT00445770|144218889|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior MTX use + treatment.||Week 4||||<0.0001
72349021|NCT00445770|144218889|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior MTX use + treatment.||Week 4||||<0.0001
72349022|NCT00445770|144218889|SUPERIORITY_OR_OTHER|||||||0.0344|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior MTX use + treatment.||Week 4||||0.0344
72349023|NCT00445770|144218889|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior MTX use + treatment.||Week 8||||<0.0001
72349024|NCT00445770|144218889|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior MTX use + treatment.||Week 8||||<0.0001
72349025|NCT00445770|144218889|SUPERIORITY_OR_OTHER|||||||0.0293|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior MTX use + treatment.||Week 8||||0.0293
72349026|NCT00445770|144218889|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior MTX use + treatment.||Week 12||||<0.0001
72349027|NCT00445770|144218889|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior MTX use + treatment.||Week 12||||<0.0001
72349028|NCT00445770|144218889|SUPERIORITY_OR_OTHER|||||||0.0452|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior MTX use + treatment.||Week 12||||0.0452
72349029|NCT00445770|144218889|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior MTX use + treatment.||Week 16||||<0.0001
72349030|NCT00445770|144218889|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior MTX use + treatment.||Week 16||||<0.0001
72429107|NCT02555371|144369129|SUPERIORITY||Ratio|0.16|||<|0.001|TWO_SIDED|95.0|0.12|0.2|||Mixed model repeated measures||Treatment comparison between mepolizumab 100 mg SC and placebo using ratio of mepolizumab to placebo and its 95% confidence interval at Week 24 has been presented.|||0.20|0.12|<0.001
72349031|NCT00445770|144218889|SUPERIORITY_OR_OTHER|||||||0.0313|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior MTX use + treatment.||Week 16||||0.0313
72349032|NCT00445770|144218889|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior MTX use + treatment.||Week 20||||<0.0001
72349033|NCT00445770|144218889|SUPERIORITY_OR_OTHER|||||||0.0019|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior MTX use + treatment.||Week 20||||0.0019
72349034|NCT00445770|144218889|SUPERIORITY_OR_OTHER|||||||0.0781|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior MTX use + treatment.||Week 20||||0.0781
72349035|NCT00445770|144218889|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior MTX use + treatment.||Week 24||||<0.0001
72349036|NCT00445770|144218889|SUPERIORITY_OR_OTHER|||||||0.0001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior MTX use + treatment.||Week 24||||0.0001
72349037|NCT00445770|144218889|SUPERIORITY_OR_OTHER|||||||0.1279|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior MTX use + treatment.||Week 24||||0.1279
72349038|NCT00445770|144218889|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior MTX use + treatment.||Week 32||||<0.0001
72349039|NCT00445770|144218889|SUPERIORITY_OR_OTHER|||||||0.0004|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior MTX use + treatment.||Week 32||||0.0004
72349040|NCT00445770|144218889|SUPERIORITY_OR_OTHER|||||||0.0807|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior MTX use + treatment.||Week 32||||0.0807
72429108|NCT02555371|144369129|SUPERIORITY||Ratio|0.19|||<|0.001|TWO_SIDED|95.0|0.15|0.24|||Mixed model repeated measures||Treatment comparison between mepolizumab 100 mg SC and placebo using ratio of mepolizumab to placebo and its 95% confidence interval at Week 36 has been presented.|||0.24|0.15|<0.001
72349041|NCT00445770|144218889|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior MTX use + treatment.||Week 40||||<0.0001
72349042|NCT00445770|144218889|SUPERIORITY_OR_OTHER|||||||0.0002|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior MTX use + treatment.||Week 40||||0.0002
72349043|NCT00445770|144218889|SUPERIORITY_OR_OTHER|||||||0.418|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior MTX use + treatment.||Week 40||||0.4180
72349044|NCT00445770|144218889|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior MTX use + treatment.||Week 48||||<0.0001
72349045|NCT00445770|144218889|SUPERIORITY_OR_OTHER|||||||0.0061|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior MTX use + treatment.||Week 48||||0.0061
72349046|NCT00445770|144218889|SUPERIORITY_OR_OTHER|||||||0.1615|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior MTX use + treatment.||Week 48||||0.1615
72349047|NCT00445770|144218889|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior MTX use + treatment.||Week 52||||<0.0001
72429109|NCT02555371|144369129|SUPERIORITY||Ratio|0.16|||<|0.001|TWO_SIDED|95.0|0.13|0.2|||Mixed model repeated measures||Treatment comparison between mepolizumab 100 mg SC and placebo using ratio of mepolizumab to placebo and its 95% confidence interval at Week 52 has been presented.|||0.20|0.13|<0.001
72349048|NCT00445770|144218889|SUPERIORITY_OR_OTHER|||||||0.013|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior MTX use + treatment.||Week 52||||0.0130
72349049|NCT00445770|144218889|SUPERIORITY_OR_OTHER|||||||0.0948|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior MTX use + treatment.||Week 52||||0.0948
72349050|NCT03058692|144218891|OTHER|||||||0.53||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.53
72349051|NCT03058692|144218891|OTHER|||||||0.56||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD8+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.56
72349052|NCT03058692|144218892|OTHER|||||||0.74||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.74
72349053|NCT03058692|144218892|OTHER|||||||0.73||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD8+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.73
72349054|NCT03058692|144218893|OTHER|||||||0.66||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.66
72349055|NCT03058692|144218893|OTHER|||||||0.48||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD8+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.48
72349056|NCT03058692|144218894|OTHER|||||||0.32||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.32
72349057|NCT03058692|144218894|OTHER||||||>|0.99||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||>0.99
72349058|NCT03058692|144218895|OTHER|||||||0.0078||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.0078
72349059|NCT03058692|144218895|OTHER|||||||0.94||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD8+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.94
72429110|NCT02555371|144369130|SUPERIORITY||Hazard Ratio (HR)|0.66||||0.005|TWO_SIDED|95.0|0.49|0.88|||Cox Proportional Hazards Model||Treatment comparison between mepolizumab 100 mg SC and placebo using hazards ratio and 95% confidence interval has been presented.|||0.88|0.49|0.005
72349060|NCT03058692|144218896|OTHER|||||||||||||||||This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.|No non-zero results were reported for either group so statistical testing was not performed.|||
72349061|NCT03058692|144218896|OTHER|||||||0.5||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD8+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.5
72349062|NCT03058692|144218897|OTHER|||||||||||||||||This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.|No non-zero results were reported for either group so statistical testing was not performed.|||
72349063|NCT03058692|144218897|OTHER|||||||||||||||||This reports the analysis for response in CD8+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.|No non-zero results were reported for either group so statistical testing was not performed.|||
72349064|NCT03058692|144218898|OTHER|||||||||||||||||This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.|No non-zero results were reported for either group so statistical testing was not performed.|||
72349065|NCT03058692|144218899|OTHER|||||||||||||||||This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.|No non-zero results were reported for either group so statistical testing was not performed.|||
72349066|NCT03058692|144218899|OTHER|||||||0.5||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD8+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.5
72349067|NCT03058692|144218900|OTHER||||||>|0.99||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||>0.99
72349068|NCT03058692|144218900|OTHER|||||||0.74||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD8+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.74
72429111|NCT02555371|144369131|SUPERIORITY||Hazard Ratio (HR)|1.33||||0.57|TWO_SIDED|95.0|0.5|3.51|||Cox Proportional Hazards Model||Treatment comparison between mepolizumab 100 mg SC and placebo using hazards ratio and 95% confidence interval has been presented.|||3.51|0.50|0.570
72349069|NCT03058692|144218901|OTHER|||||||0.5||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.50
72349070|NCT03058692|144218901|OTHER|||||||0.9||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD8+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.90
72429112|NCT01603940|144369182|SUPERIORITY_OR_OTHER|||||||0.616|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.616
72429113|NCT01603940|144369183|SUPERIORITY_OR_OTHER|||||||0.28|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.28
72429114|NCT01603940|144369184|SUPERIORITY_OR_OTHER|||||||0.618|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.618
72429115|NCT01474512|144369223|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Regression, Logistic|Logistic Regression analysis included treatment, geographic region, previous non-biologic systemic therapy and baseline weight category as factors.||||||<0.001
72349071|NCT03058692|144218902|OTHER|||||||0.87||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.87
72349072|NCT03058692|144218902|OTHER|||||||0.57||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD8+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.57
72349073|NCT03058692|144218903|OTHER|||||||0.82||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.82
72349074|NCT03058692|144218903|OTHER|||||||0.076||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD8+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.076
72349075|NCT03058692|144218904|OTHER||||||>|0.99||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||>0.99
72349076|NCT03058692|144218904|OTHER|||||||0.75||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD8+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.75
72349077|NCT03058692|144218905|OTHER|||||||0.5||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.50
72349078|NCT03058692|144218905|OTHER|||||||0.5||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD8+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.50
72349079|NCT03058692|144218906|OTHER||||||>|0.99||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||>.99
72349080|NCT03058692|144218906|OTHER||||||>|0.99||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD8+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||>.99
72429116|NCT01474512|144369223|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Regression, Logistic|Logistic Regression analysis included treatment, geographic region, previous non-biologic systemic therapy and baseline weight category as factors.||||||<0.001
72429117|NCT01474512|144369224|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Regression, Logistic|Logistic Regression analysis included treatment, geographic region, previous non-biologic systemic therapy and baseline weight category as factors.||||||<0.001
72349081|NCT03058692|144218907|OTHER|||||||0.81||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.81
72349082|NCT03058692|144218907|OTHER|||||||0.47||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD8+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.47
72349083|NCT03058692|144218908|OTHER|||||||0.0061||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.0061
72349084|NCT03058692|144218908|OTHER|||||||0.28||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD8+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.28
72349085|NCT03058692|144218909|OTHER|||||||0.36||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.36
72349086|NCT03058692|144218909|OTHER|||||||0.32||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD8+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.32
72349087|NCT03058692|144218910|OTHER|||||||0.42||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.42
72349088|NCT03058692|144218910|OTHER|||||||0.26||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD8+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.26
72349089|NCT03058692|144218911|OTHER|||||||0.53||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.53
72349090|NCT03058692|144218911|OTHER|||||||0.56||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.56
72429118|NCT01474512|144369224|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Regression, Logistic|Logistic Regression analysis included treatment, geographic region, previous non-biologic systemic therapy and baseline weight category as factors.||||||<0.001
72429119|NCT01474512|144369225|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Fisher Exact|Due to the zero count in placebo group, p-values from Logistic Regression were not obtainable, therefore the p-value is from Fisher's exact test.||||||<0.001
72349091|NCT03058692|144218912|OTHER|||||||0.97||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.97
72349092|NCT03058692|144218912|OTHER|||||||0.62||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD8+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.62
72349093|NCT03058692|144218913|OTHER|||||||0.15||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.15
72349094|NCT03058692|144218913|OTHER|||||||0.18||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD8+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.18
72349095|NCT03058692|144218914|OTHER|||||||0.94||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.94
72349096|NCT03058692|144218914|OTHER|||||||||||||||||This reports the analysis for response in CD8+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.|No non-zero results were reported for either group so statistical testing was not performed.|||
72349097|NCT03058692|144218915|OTHER|||||||0.14||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.14
72349098|NCT03058692|144218915|OTHER|||||||0.26||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD8+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.26
72349099|NCT03058692|144218916|OTHER|||||||0.72||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.72
72349100|NCT03058692|144218916|OTHER|||||||0.31||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD8+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.31
72349101|NCT03058692|144218917|OTHER|||||||0.31||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.31
72429120|NCT01474512|144369225|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Fisher Exact|Due to the zero count in placebo group, p-values from Logistic Regression were not obtainable, therefore the p-value is from Fisher's exact test.||||||<0.001
72349102|NCT03058692|144218917|OTHER|||||||0.22||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD8+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.22
72349103|NCT03058692|144218918|OTHER|||||||0.16||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.16
72349104|NCT03058692|144218918|OTHER|||||||0.44||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD8+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.44
72349105|NCT03058692|144218919|OTHER|||||||0.67||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.67
72349106|NCT03058692|144218919|OTHER|||||||0.48||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD8+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.48
72349107|NCT03058692|144218920|OTHER||||||<|0.001||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||<0.001
72349108|NCT03058692|144218920|OTHER|||||||0.62||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD8+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.62
72349109|NCT03058692|144218921|OTHER|||||||0.0093||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.0093
72349110|NCT03058692|144218921|OTHER|||||||0.51||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD8+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.51
72349111|NCT03058692|144218922|OTHER|||||||0.54||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.54
72429121|NCT01474512|144369226|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||P-value is for PASI90.|Regression, Logistic|Logistic Regression analysis included treatment, geographic region, previous non-biologic systemic therapy and baseline weight category as factors.||||||<0.001
72429122|NCT01474512|144369226|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||P-value is for PASI90.|Regression, Logistic|Logistic Regression analysis included treatment, geographic region, previous non-biologic systemic therapy and baseline weight category as factors.||||||<0.001
72349112|NCT03058692|144218922|OTHER|||||||0.43||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD8+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.43
72349113|NCT03058692|144218923|OTHER|||||||0.44||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.44
72349114|NCT03058692|144218923|OTHER|||||||0.014||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD8+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.014
72349115|NCT03058692|144218924|OTHER||||||<|0.001||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||<0.001
72349116|NCT03058692|144218924|OTHER|||||||0.96||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD8+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.96
72349117|NCT03058692|144218925|OTHER|||||||0.65||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.65
72349118|NCT03058692|144218925|OTHER|||||||0.53||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.53
72349119|NCT03058692|144218926|OTHER|||||||0.35||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.35
72349120|NCT03058692|144218926|OTHER|||||||0.66||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD8+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.66
72349121|NCT03058692|144218927|OTHER|||||||0.86||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.86
72429123|NCT01474512|144369226|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||P-value is for PASI100.|Fisher Exact|Due to the zero count in placebo group, p-values from Logistic Regression were not obtainable; therefore the p-value is from Fisher's exact test.||||||<0.001
72429124|NCT01474512|144369226|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||P-value is for PASI100.|Fisher Exact|Due to the zero count in placebo group, p-values from Logistic Regression were not obtainable; therefore the p-value is from Fisher's exact test.||||||<0.001
72429125|NCT01474512|144369227|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Regression, Logistic|Logistic Regression analysis included treatment and baseline weight category as factors.||||||<0.001
72349122|NCT03058692|144218927|OTHER|||||||0.53||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.53
72349123|NCT03329092|144218976|OTHER||Difference in clinical cure rate|2.7|||||TWO_SIDED|95.0|-6.6|12.4|||||The confidence interval (CI) for the difference was calculated using the unstratified Miettinen and Nurminen method.|||12.4|-6.6|
72349124|NCT03329092|144218977|OTHER||Difference in clinical cure rate|2.7|||||TWO_SIDED|95.0|-7.0|13.2|||||The CI for the difference was calculated using the unstratified Miettinen and Nurminen method.|||13.2|-7.0|
72349125|NCT03329092|144218978|OTHER||Difference in clinical cure rate|0.5|||||TWO_SIDED|95.0|-10.2|12.1|||||CI for the difference was calculated using the unstratified Miettinen and Nurminen method.|||12.1|-10.2|
72349126|NCT03329092|144218979|OTHER||Difference in clinical cure rate|2.6|||||TWO_SIDED|95.0|-8.4|14.7|||||CI for the difference was calculated using the unstratified Miettinen and Nurminen method.|||14.7|-8.4|
72349127|NCT03329092|144218980|OTHER||Difference in clinical cure rate|2.4|||||TWO_SIDED|95.0|-7.4|13.0|||||CI for the difference was calculated using the unstratified Miettinen and Nurminen method.|cIAI||13.0|-7.4|
72349128|NCT03329092|144218980|OTHER||Difference in clinical cure rate|4.3|||||TWO_SIDED|95.0|-15.5|23.1|||Difference||CI for the difference was calculated using the unstratified Miettinen and Nurminen method.|HAP/VAP||23.1|-15.5|
72349129|NCT03329092|144218981|OTHER||Difference in clinical cure rate|5.6|||||TWO_SIDED|95.0|-4.0|16.6|||||CI for the difference was calculated using the unstratified Miettinen and Nurminen method.|cIAI||16.6|-4.0|
72349130|NCT03329092|144218981|OTHER||Difference in clinical cure rate|-7.9|||||TWO_SIDED|95.0|-31.9|17.3|||||CI for the difference was calculated using the unstratified Miettinen and Nurminen method.|HAP/VAP||17.3|-31.9|
72349131|NCT03329092|144219008|OTHER||Difference in clinical cure rate|2.3|||||TWO_SIDED|95.0|-6.2|11.5|||||CI for the difference was calculated using the unstratified Miettinen and Nurminen method.|||11.5|-6.2|
72349132|NCT03329092|144219009|OTHER||Difference in clinical cure|-1.2|||||TWO_SIDED|95.0|-10.7|9.4|||||CI for the difference was calculated using the unstratified Miettinen and Nurminen method.|||9.4|-10.7|
72349133|NCT03329092|144219010|OTHER||Difference in clinical cure|0.3|||||TWO_SIDED|95.0|-8.3|9.9|||||CI for the difference was calculated using the unstratified Miettinen and Nurminen method.|||9.9|-8.3|
72349134|NCT03329092|144219011|OTHER||Difference in clinical cure rate|1.0|||||TWO_SIDED|95.0|-8.5|12.0|||||CI for the difference was calculated using the unstratified Miettinen and Nurminen method.|||12.0|-8.5|
72349135|NCT03329092|144219012|OTHER||Difference in clinical cure rate|1.9|||||TWO_SIDED|95.0|-6.9|11.9|||||CI for the difference was calculated using the unstratified Miettinen and Nurminen method.|cIAI||11.9|-6.9|
72349136|NCT03329092|144219012|OTHER||Difference in clinical cure rate|3.9|||||TWO_SIDED|95.0|-15.2|23.4|||||CI for the difference was calculated using the unstratified Miettinen and Nurminen method.|HAP/VAP||23.4|-15.2|
72349137|NCT03329092|144219013|OTHER||Difference in clinical cure rate|3.1|||||TWO_SIDED|95.0|-5.2|13.2|||||CI for the difference was calculated using the unstratified Miettinen and Nurminen method.|cIAI||13.2|-5.2|
72349138|NCT03329092|144219013|OTHER||Difference in clinical cure rate|-10.4|||||TWO_SIDED|95.0|-32.6|14.9|||||CI for the difference was calculated using the unstratified Miettinen and Nurminen method.|HAP/VAP||14.9|-32.6|
72349139|NCT01200368|144219100|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower confidence interval for the percent difference was greater than (\>) -0.10.|Percent difference|0.0|||||TWO_SIDED|95.0|-2.2|2.1||||||Serotype 4: Difference (\[13vPnC + DTaP\] - \[7vPnC + DTaP\]) in proportions, expressed as a percentage presented along with exact 2-sided 95 percent (%) confidence interval (CI).||2.1|-2.2|
72429126|NCT01474512|144369227|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Regression, Logistic|Logistic Regression analysis included treatment and baseline weight category as factors.||||||<0.001
72349140|NCT01200368|144219100|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower confidence interval for the percent difference was \>-0.10.|Percent difference|-1.7|||||TWO_SIDED|95.0|-5.2|1.1||||||Serotype 6B: Difference (\[13vPnC + DTaP\] - \[7vPnC + DTaP\]) in proportions, expressed as a percentage presented along with exact 2-sided 95% CI.||1.1|-5.2|
72349141|NCT01200368|144219100|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower confidence interval for the percent difference was \>-0.10.|Percent difference|0.0|||||TWO_SIDED|95.0|-2.1|2.1||||||Serotype 9V: Difference (\[13vPnC + DTaP\] - \[7vPnC + DTaP\]) in proportions, expressed as a percentage presented along with exact 2-sided 95% CI.||2.1|-2.1|
72349142|NCT01200368|144219100|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower confidence interval for the percent difference was \>-0.10.|Percent difference|0.0|||||TWO_SIDED|95.0|-2.1|2.1||||||Serotype 14: Difference (\[13vPnC + DTaP\] - \[7vPnC + DTaP\]) in proportions, expressed as a percentage presented along with exact 2-sided 95% CI.||2.1|-2.1|
72349143|NCT01200368|144219100|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower confidence interval for the percent difference was \>-0.10.|Percent difference|0.0|||||TWO_SIDED|95.0|-2.1|2.1||||||Serotype 18C: Difference (\[13vPnC + DTaP\] - \[7vPnC + DTaP\]) in proportions, expressed as a percentage presented along with exact 2-sided 95% CI.||2.1|-2.1|
72349144|NCT01200368|144219100|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower confidence interval for the percent difference was \>-0.10.|Percent difference|2.3|||||TWO_SIDED|95.0|-1.1|6.3||||||Serotype 19F: Difference (\[13vPnC + DTaP\] - \[7vPnC + DTaP\]) in proportions, expressed as a percentage presented along with exact 2-sided 95% CI.||6.3|-1.1|
72349145|NCT01200368|144219100|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower confidence interval for the percent difference was \>-0.10.|Percent difference|-0.6|||||TWO_SIDED|95.0|-4.2|2.9||||||Serotype 23F: Difference (\[13vPnC + DTaP\] - \[7vPnC + DTaP\]) in proportions, expressed as a percentage presented along with exact 2-sided 95% CI.||2.9|-4.2|
72429127|NCT01474512|144369228|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Regression, Logistic|Logistic Regression analysis included treatment, geographic region, previous non-biologic systemic therapy and baseline weight category as factors.||||||<0.001
72349146|NCT01200368|144219100|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower confidence interval for the percent difference was \>-0.10.|Percent difference|3.4|||||TWO_SIDED|95.0|0.9|7.3||||||Serotype 1: Difference (\[13vPnC + DTaP\] - \[7vPnC + DTaP\]) in proportions, expressed as a percentage presented along with exact 2-sided 95% CI. Difference in proportions was calculated using the serotype with the lowest proportion among the 7 common serotypes in the 7vPnC + DTaP group as reference.||7.3|0.9|
72349147|NCT01200368|144219100|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower confidence interval for the percent difference was \>-0.10.|Percent difference|2.9|||||TWO_SIDED|95.0|-0.2|6.7||||||Serotype 3: Difference (\[13vPnC + DTaP\] - \[7vPnC + DTaP\]) in proportions, expressed as a percentage presented along with exact 2-sided 95% CI. Difference in proportions was calculated using the serotype with the lowest proportion among the 7 common serotypes in the 7vPnC + DTaP group as reference.||6.7|-0.2|
72349148|NCT01200368|144219100|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower confidence interval for the percent difference was \>-0.10.|Percent difference|2.9|||||TWO_SIDED|95.0|-0.2|6.7||||||Serotype 5: Difference (\[13vPnC + DTaP\] - \[7vPnC + DTaP\]) in proportions, expressed as a percentage presented along with exact 2-sided 95% CI. Difference in proportions was calculated using the serotype with the lowest proportion among the 7 common serotypes in the 7vPnC + DTaP group as reference.||6.7|-0.2|
72349149|NCT01200368|144219100|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower confidence interval for the percent difference was \>-0.10.|Percent difference|1.7|||||TWO_SIDED|95.0|-1.9|5.8||||||Serotype 6A: Difference (\[13vPnC + DTaP\] - \[7vPnC + DTaP\]) in proportions, expressed as a percentage presented along with exact 2-sided 95% CI. Difference in proportions was calculated using the serotype with the lowest proportion among the 7 common serotypes in the 7vPnC + DTaP group as reference.||5.8|-1.9|
72349150|NCT01200368|144219100|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower confidence interval for the percent difference was \>-0.10.|Percent difference|3.4|||||TWO_SIDED|95.0|0.9|7.3||||||Serotype 7F: Difference (\[13vPnC + DTaP\] - \[7vPnC + DTaP\]) in proportions, expressed as a percentage presented along with exact 2-sided 95% CI. Difference in proportions was calculated using the serotype with the lowest proportion among the 7 common serotypes in the 7vPnC + DTaP group as reference.||7.3|0.9|
72349151|NCT01200368|144219100|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower confidence interval for the percent difference was \>-0.10.|Percent difference|3.4|||||TWO_SIDED|95.0|1.0|7.3||||||Serotype 19A: Difference (\[13vPnC + DTaP\] - \[7vPnC + DTaP\]) in proportions, expressed as a percentage presented along with exact 2-sided 95% CI. Difference in proportions was calculated using the serotype with the lowest proportion among the 7 common serotypes in the 7vPnC + DTaP group as reference.||7.3|1.0|
72349152|NCT01200368|144219101|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower limit of the 2-sided, 95% CI for the IgG GMC ratio was \>0.5.|GMC ratio|0.81|||||TWO_SIDED|95.0|0.71|0.94||||||Serotype 4: Ratio of IgG GMCs (\[13vPnC + DTaP\]/\[7vPnC + DTaP\]) was calculated along with 2-sided 95% CI.||0.94|0.71|
72349153|NCT01200368|144219101|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower limit of the 2-sided, 95% CI for IgG GMC ratio was \>0.5.|GMC ratio|0.79|||||TWO_SIDED|95.0|0.64|0.97||||||Serotype 6B: Ratio of IgG GMCs (\[13vPnC + DTaP\]/\[7vPnC + DTaP\]) was calculated along with 2-sided 95% CI.||0.97|0.64|
72349154|NCT01200368|144219101|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower limit of the 2-sided, 95% CI for IgG GMC ratio was \>0.5.|GMC ratio|0.74|||||TWO_SIDED|95.0|0.64|0.86||||||Serotype 9V: Ratio of IgG GMCs (\[13vPnC + DTaP\]/\[7vPnC + DTaP\]) was calculated along with 2-sided 95% CI.||0.86|0.64|
72349155|NCT01200368|144219101|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower limit of the 2-sided, 95% CI for IgG GMC ratio was \>0.5.|GMC ratio|0.83|||||TWO_SIDED|95.0|0.7|0.98||||||Serotype 14: Ratio of IgG GMCs (\[13vPnC + DTaP\]/\[7vPnC + DTaP\]) was calculated along with 2-sided 95% CI.||0.98|0.70|
72349156|NCT01200368|144219101|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower limit of the 2-sided, 95% CI for IgG GMC ratio was \>0.5.|GMC ratio|0.73|||||TWO_SIDED|95.0|0.63|0.85||||||Serotype 18C: Ratio of IgG GMCs (\[13vPnC + DTaP\]/\[7vPnC + DTaP\]) was calculated along with 2-sided 95% CI.||0.85|0.63|
72429128|NCT01474512|144369228|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Regression, Logistic|Logistic Regression analysis included treatment, geographic region, previous non-biologic systemic therapy and baseline weight category as factors.||||||<0.001
72349157|NCT01200368|144219101|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower limit of the 2-sided, 95% CI for IgG GMC ratio was \>0.5.|GMC ratio|0.88|||||TWO_SIDED|95.0|0.72|1.08||||||Serotype 19F: Ratio of IgG GMCs (\[13vPnC + DTaP\]/\[7vPnC + DTaP\]) was calculated along with 2-sided 95% CI.||1.08|0.72|
72349158|NCT01200368|144219101|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower limit of the 2-sided, 95% CI for IgG GMC ratio was \>0.5.|GMC ratio|0.8|||||TWO_SIDED|95.0|0.66|0.98||||||Serotype 23F: Ratio of IgG GMCs (\[13vPnC + DTaP\]/\[7vPnC + DTaP\]) was calculated along with 2-sided 95% CI.||0.98|0.66|
72349159|NCT01200368|144219102|SUPERIORITY_OR_OTHER||Percent difference|-0.6|||||TWO_SIDED|95.0|-3.1|1.6||||||Difference in percentage of participants achieving predefined antibody levels for diphtheria toxoid and corresponding 2-sided 95% CI were calculated.||1.6|-3.1|
72349160|NCT01200368|144219102|SUPERIORITY_OR_OTHER||Percent difference|0.0|||||TWO_SIDED|95.0|-2.1|2.2||||||Difference in percentage of participants achieving predefined antibody levels for tetanus toxoid and corresponding 2-sided 95% CI were calculated.||2.2|-2.1|
72349161|NCT01200368|144219102|SUPERIORITY_OR_OTHER||Percent difference|-0.6|||||TWO_SIDED|95.0|-3.1|1.6||||||Difference in percentage of participants achieving predefined antibody levels for pertussis toxoid and corresponding 2-sided 95% CI were calculated.||1.6|-3.1|
72349162|NCT01200368|144219102|SUPERIORITY_OR_OTHER||Percent difference|-0.6|||||TWO_SIDED|95.0|-3.1|1.6||||||Difference in percentage of participants achieving predefined antibody levels for filamentous hemagglutinin and corresponding 2-sided 95% CI were calculated.||1.6|-3.1|
72429129|NCT01474512|144369229|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||LS mean and P-value were calculated using MMRM with baseline score as a covariate, treatment, geographic region, previous non-biologic systemic therapy, baseline weight category, visit and treatment-by-visit interaction as fixed effects.|Mixed Models Analysis|||||||<0.001
72429130|NCT01474512|144369229|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||LS mean and P-value were calculated using MMRM with baseline score as a covariate, treatment, geographic region, previous non-biologic systemic therapy, baseline weight category, visit and treatment-by-visit interaction as fixed effects.|Mixed Models Analysis|||||||<0.001
72349163|NCT01200368|144219103|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower limit of the 2-sided, 95% CI for IgG GMC ratio was \>0.5.|GMC ratio|1.8|||||TWO_SIDED|95.0|1.5|2.15||||||Serotype 1: Ratio of IgG GMCs (\[13vPnC + DTaP\]/\[7vPnC + DTaP\]) was calculated along with 2-sided 95% CI. GMC ratio was calculated using the serotype with the lowest GMC among the 7 common serotypes in the 7vPnC + DTaP group as reference.||2.15|1.50|
72349164|NCT01200368|144219103|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower limit of the 2-sided, 95% CI for IgG GMC ratio was \>0.5.|GMC ratio|1.08|||||TWO_SIDED|95.0|0.92|1.28||||||Serotype 3: Ratio of IgG GMCs (\[13vPnC + DTaP\]/\[7vPnC + DTaP\]) was calculated along with 2-sided 95% CI. GMC ratio was calculated using the serotype with the lowest GMC among the 7 common serotypes in the 7vPnC + DTaP group as reference.||1.28|0.92|
72349165|NCT01200368|144219103|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower limit of the 2-sided, 95% CI for IgG GMC ratio was \>0.5.|GMC ratio|1.03|||||TWO_SIDED|95.0|0.86|1.22||||||Serotype 5: Ratio of IgG GMCs (\[13vPnC + DTaP\]/\[7vPnC + DTaP\]) was calculated along with 2-sided 95% CI. GMC ratio was calculated using the serotype with the lowest GMC among the 7 common serotypes in the 7vPnC + DTaP group as reference.||1.22|0.86|
72349166|NCT01200368|144219103|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower limit of the 2-sided, 95% CI for IgG GMC ratio was \>0.5.|GMC ratio|1.04|||||TWO_SIDED|95.0|0.87|1.25||||||Serotype 6A: Ratio of IgG GMCs (\[13vPnC + DTaP\]/\[7vPnC + DTaP\]) was calculated along with 2-sided 95% CI. GMC ratio was calculated using the serotype with the lowest GMC among the 7 common serotypes in the 7vPnC + DTaP group as reference.||1.25|0.87|
72349167|NCT01200368|144219103|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower limit of the 2-sided, 95% CI for IgG GMC ratio was \>0.5.|GMC ratio|1.83|||||TWO_SIDED|95.0|1.54|2.16||||||Serotype 7F: Ratio of IgG GMCs (\[13vPnC + DTaP\]/\[7vPnC + DTaP\]) was calculated along with 2-sided 95% CI. GMC ratio was calculated using the serotype with the lowest GMC among the 7 common serotypes in the 7vPnC + DTaP group as reference.||2.16|1.54|
72349168|NCT01200368|144219103|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower limit of the 2-sided, 95% CI for IgG GMC ratio was \>0.5.|GMC ratio|1.89|||||TWO_SIDED|95.0|1.59|2.25||||||Serotype 19A: Ratio of IgG GMCs (\[13vPnC + DTaP\]/\[7vPnC + DTaP\]) was calculated along with 2-sided 95% CI. GMC ratio was calculated using the serotype with the lowest GMC among the 7 common serotypes in the 7vPnC + DTaP group as reference.||2.25|1.59|
72349169|NCT01200368|144219104|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower confidence interval for the percent difference was \>-0.10.|Percent difference|0.0|||||TWO_SIDED|95.0|-2.4|2.4||||||Serotype 4: Difference (\[13vPnC + DTaP\] - \[7vPnC + DTaP\]) in proportions, expressed as a percentage presented along with exact 2-sided 95% CI.||2.4|-2.4|
72349170|NCT01200368|144219104|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower confidence interval for the percent difference was \>-0.10.|Percent difference|0.0|||||TWO_SIDED|95.0|-2.4|2.4||||||Serotype 6B: Difference (\[13vPnC + DTaP\] - \[7vPnC + DTaP\]) in proportions, expressed as a percentage presented along with exact 2-sided 95% CI.||2.4|-2.4|
72349171|NCT01200368|144219104|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower confidence interval for the percent difference was \>-0.10.|Percent difference|0.0|||||TWO_SIDED|95.0|-2.4|2.4||||||Serotype 9V: Difference (\[13vPnC + DTaP\] - \[7vPnC + DTaP\]) in proportions, expressed as a percentage presented along with exact 2-sided 95% CI.||2.4|-2.4|
72349172|NCT01200368|144219104|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower confidence interval for the percent difference was \>-0.10.|Percent difference|0.0|||||TWO_SIDED|95.0|-2.4|2.4||||||Serotype 14: Difference (\[13vPnC + DTaP\] - \[7vPnC + DTaP\]) in proportions, expressed as a percentage presented along with exact 2-sided 95% CI.||2.4|-2.4|
72349173|NCT01200368|144219104|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower confidence interval for the percent difference was \>-0.10.|Percent difference|0.0|||||TWO_SIDED|95.0|-2.4|2.4||||||Serotype 18C: Difference (\[13vPnC + DTaP\] - \[7vPnC + DTaP\]) in proportions, expressed as a percentage presented along with exact 2-sided 95% CI.||2.4|-2.4|
72429131|NCT01474512|144369230|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||LS mean and P-value were calculated using MMRM with baseline score as a covariate, treatment, geographic region, previous non-biologic systemic therapy, baseline weight category, visit and treatment-by-visit interaction as fixed effects.|Mixed Models Analysis|||||||<0.001
72429132|NCT01474512|144369230|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||LS mean and P-value were calculated using MMRM with baseline score as a covariate, treatment, geographic region, previous non-biologic systemic therapy, baseline weight category, visit and treatment-by-visit interaction as fixed effects.|Mixed Models Analysis|||||||<0.001
72429133|NCT01474512|144369231|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||LS mean and P-value were calculated using MMRM with baseline score as a covariate, treatment, geographic region, previous non-biologic systemic therapy, baseline weight category, visit and treatment-by-visit interaction as fixed effects.|Mixed Models Analysis|||||||<0.001
72349174|NCT01200368|144219104|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower confidence interval for the percent difference was \>-0.10.|Percent difference|-0.6|||||TWO_SIDED|95.0|-3.9|2.4||||||Serotype 19F: Difference (\[13vPnC + DTaP\] - \[7vPnC + DTaP\]) in proportions, expressed as a percentage presented along with exact 2-sided 95% CI.||2.4|-3.9|
72349175|NCT01200368|144219104|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower confidence interval for the percent difference was \>-0.10.|Percent difference|0.0|||||TWO_SIDED|95.0|-2.4|2.4||||||Serotype 23F: Difference (\[13vPnC + DTaP\] - \[7vPnC + DTaP\]) in proportions, expressed as a percentage presented along with exact 2-sided 95% CI.||2.4|-2.4|
72349176|NCT01200368|144219104|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower confidence interval for the percent difference was \>-0.10.|Percent difference|0.0|||||TWO_SIDED|95.0|-2.9|3.0||||||Serotype 1: Difference (\[13vPnC + DTaP\] - \[7vPnC + DTaP\]) in proportions, expressed as a percentage presented along with exact 2-sided 95% CI. Difference in proportions was calculated using the serotype with the lowest proportion among the 7 common serotypes in the 7vPnC + DTaP group as reference.||3.0|-2.9|
72349177|NCT01200368|144219104|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower confidence interval for the percent difference was \>-0.10.|Percent difference|0.0|||||TWO_SIDED|95.0|-2.9|3.0||||||Serotype 3: Difference (\[13vPnC + DTaP\] - \[7vPnC + DTaP\]) in proportions, expressed as a percentage presented along with exact 2-sided 95% CI. Difference in proportions was calculated using the serotype with the lowest proportion among the 7 common serotypes in the 7vPnC + DTaP group as reference.||3.0|-2.9|
72349178|NCT01200368|144219104|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower confidence interval for the percent difference was \>-0.10.|Percent difference|0.6|||||TWO_SIDED|95.0|-1.7|3.6||||||Serotype 5: Difference (\[13vPnC + DTaP\] - \[7vPnC + DTaP\]) in proportions, expressed as a percentage presented along with exact 2-sided 95% CI. Difference in proportions was calculated using the serotype with the lowest proportion among the 7 common serotypes in the 7vPnC + DTaP group as reference.||3.6|-1.7|
72349179|NCT01200368|144219104|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower confidence interval for the percent difference was \>-0.10.|Percent difference|0.6|||||TWO_SIDED|95.0|-1.7|3.6||||||Serotype 6A: Difference (\[13vPnC + DTaP\] - \[7vPnC + DTaP\]) in proportions, expressed as a percentage presented along with exact 2-sided 95% CI. Difference in proportions was calculated using the serotype with the lowest proportion among the 7 common serotypes in the 7vPnC + DTaP group as reference.||3.6|-1.7|
72349180|NCT01200368|144219104|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower confidence interval for the percent difference was \>-0.10.|Percent difference|0.6|||||TWO_SIDED|95.0|-1.7|3.6||||||Serotype 7F: Difference (\[13vPnC + DTaP\] - \[7vPnC + DTaP\]) in proportions, expressed as a percentage presented along with exact 2-sided 95% CI. Difference in proportions was calculated using the serotype with the lowest proportion among the 7 common serotypes in the 7vPnC + DTaP group as reference.||3.6|-1.7|
72349181|NCT01200368|144219104|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower confidence interval for the percent difference was \>-0.10.|Percent difference|0.6|||||TWO_SIDED|95.0|-1.7|3.6||||||Serotype 19A: Difference (\[13vPnC + DTaP\] - \[7vPnC + DTaP\]) in proportions, expressed as a percentage presented along with exact 2-sided 95% CI. Difference in proportions was calculated using the serotype with the lowest proportion among the 7 common serotypes in the 7vPnC + DTaP group as reference.||3.6|-1.7|
72349182|NCT01200368|144219105|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower limit of the 2-sided, 95% CI for IgG GMC ratio was \>0.5.|GMC ratio|0.94|||||TWO_SIDED|95.0|0.77|1.15||||||Serotype 4: Ratio of IgG GMCs (\[13vPnC + DTaP\]/\[7vPnC + DTaP\]) was calculated along with 2-sided 95% CI.||1.15|0.77|
72349183|NCT01200368|144219105|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower limit of the 2-sided, 95% CI for IgG GMC ratio was \>0.5.|GMC ratio|1.23|||||TWO_SIDED|95.0|0.98|1.53||||||Serotype 6B: Ratio of IgG GMCs (\[13vPnC + DTaP\]/\[7vPnC + DTaP\]) was calculated along with 2-sided 95% CI.||1.53|0.98|
72349184|NCT01200368|144219105|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower limit of the 2-sided, 95% CI for IgG GMC ratio was \>0.5.|GMC ratio|0.81|||||TWO_SIDED|95.0|0.67|0.98||||||Serotype 9V: Ratio of IgG GMCs (\[13vPnC + DTaP\]/\[7vPnC + DTaP\]) was calculated along with 2-sided 95% CI.||0.98|0.67|
72429134|NCT01474512|144369231|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||LS mean and P-value were calculated using MMRM with baseline score as a covariate, treatment, geographic region, previous non-biologic systemic therapy, baseline weight category, visit and treatment-by-visit interaction as fixed effects.|Mixed Models Analysis|||||||<0.001
72349185|NCT01200368|144219105|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower limit of the 2-sided, 95% CI for IgG GMC ratio was \>0.5.|GMC ratio|0.95|||||TWO_SIDED|95.0|0.81|1.12||||||Serotype 14: Ratio of IgG GMCs (\[13vPnC + DTaP\]/\[7vPnC + DTaP\]) was calculated along with 2-sided 95% CI.||1.12|0.81|
72349186|NCT01200368|144219105|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower limit of the 2-sided, 95% CI for IgG GMC ratio was \>0.5.|GMC ratio|0.82|||||TWO_SIDED|95.0|0.67|1.01||||||Serotype 18C: Ratio of IgG GMCs (\[13vPnC + DTaP\]/\[7vPnC + DTaP\]) was calculated along with 2-sided 95% CI.||1.01|0.67|
72349187|NCT01200368|144219105|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower limit of the 2-sided, 95% CI for IgG GMC ratio was \>0.5.|GMC ratio|1.75|||||TWO_SIDED|95.0|1.39|2.21||||||Serotype 19F: Ratio of IgG GMCs (\[13vPnC + DTaP\]/\[7vPnC + DTaP\]) was calculated along with 2-sided 95% CI.||2.21|1.39|
72349188|NCT01200368|144219105|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower limit of the 2-sided, 95% CI for IgG GMC ratio was \>0.5.|GMC ratio|0.86|||||TWO_SIDED|95.0|0.7|1.07||||||Serotype 23F: Ratio of IgG GMCs (\[13vPnC + DTaP\]/\[7vPnC + DTaP\]) was calculated along with 2-sided 95% CI.||1.07|0.70|
72349189|NCT01200368|144219105|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower limit of the 2-sided, 95% CI for IgG GMC ratio was \>0.5.|GMC ratio|1.62|||||TWO_SIDED|95.0|1.31|1.99||||||Serotype 1: Ratio of IgG GMCs (\[13vPnC + DTaP\]/\[7vPnC + DTaP\]) was calculated along with 2-sided 95% CI. GMC ratio was calculated using the serotype with the lowest GMC among the 7 common serotypes in the 7vPnC + DTaP group as reference.||1.99|1.31|
72349190|NCT01200368|144219105|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower limit of the 2-sided, 95% CI for IgG GMC ratio was \>0.5.|GMC ratio|0.29|||||TWO_SIDED|95.0|0.24|0.35||||||Serotype 3: Ratio of IgG GMCs (\[13vPnC + DTaP\]/\[7vPnC + DTaP\]) was calculated along with 2-sided 95% CI. GMC ratio was calculated using the serotype with the lowest GMC among the 7 common serotypes in the 7vPnC + DTaP group as reference.||0.35|0.24|
72349191|NCT01200368|144219105|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower limit of the 2-sided, 95% CI for IgG GMC ratio was \>0.5.|GMC ratio|1.28|||||TWO_SIDED|95.0|1.07|1.54||||||Serotype 5: Ratio of IgG GMCs (\[13vPnC + DTaP\]/\[7vPnC + DTaP\]) was calculated along with 2-sided 95% CI. GMC ratio was calculated using the serotype with the lowest GMC among the 7 common serotypes in the 7vPnC + DTaP group as reference.||1.54|1.07|
72349192|NCT01200368|144219105|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower limit of the 2-sided, 95% CI for IgG GMC ratio was \>0.5.|GMC ratio|1.76|||||TWO_SIDED|95.0|1.46|2.12||||||Serotype 6A: Ratio of IgG GMCs (\[13vPnC + DTaP\]/\[7vPnC + DTaP\]) was calculated along with 2-sided 95% CI. GMC ratio was calculated using the serotype with the lowest GMC among the 7 common serotypes in the 7vPnC + DTaP group as reference.||2.12|1.46|
72349193|NCT01200368|144219105|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower limit of the 2-sided, 95% CI for IgG GMC ratio was \>0.5.|GMC ratio|1.26|||||TWO_SIDED|95.0|1.04|1.52||||||Serotype 7F: Ratio of IgG GMCs (\[13vPnC + DTaP\]/\[7vPnC + DTaP\]) was calculated along with 2-sided 95% CI. GMC ratio was calculated using the serotype with the lowest GMC among the 7 common serotypes in the 7vPnC + DTaP group as reference.||1.52|1.04|
72349194|NCT01200368|144219105|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower limit of the 2-sided, 95% CI for IgG GMC ratio was \>0.5.|GMC ratio|1.85|||||TWO_SIDED|95.0|1.54|2.24||||||Serotype 19A: Ratio of IgG GMCs (\[13vPnC + DTaP\]/\[7vPnC + DTaP\]) was calculated along with 2-sided 95% CI. GMC ratio was calculated using the serotype with the lowest GMC among the 7 common serotypes in the 7vPnC + DTaP group as reference.||2.24|1.54|
72349195|NCT01200368|144219106|SUPERIORITY_OR_OTHER||Percent difference|0.0|||||TWO_SIDED|95.0|-2.4|2.3||||||Difference in percentage of participants achieving predefined antibody levels for diphtheria toxoid and corresponding 2-sided 95% CI were calculated.||2.3|-2.4|
72349196|NCT01200368|144219106|SUPERIORITY_OR_OTHER||Percent difference|0.0|||||TWO_SIDED|95.0|-2.4|2.3||||||Difference in percentage of participants achieving predefined antibody levels for tetanus toxoid and corresponding 2-sided 95% CI were calculated.||2.3|-2.4|
72349197|NCT01200368|144219106|SUPERIORITY_OR_OTHER||Percent difference|0.0|||||TWO_SIDED|95.0|-2.4|2.3||||||Difference in percentage of participants achieving predefined antibody levels for pertussis toxoid and corresponding 2-sided 95% CI were calculated.||2.3|-2.4|
72349198|NCT01200368|144219106|SUPERIORITY_OR_OTHER||Percent difference|0.0|||||TWO_SIDED|95.0|-2.4|2.3||||||Difference in percentage of participants achieving predefined antibody levels for filamentous hemagglutinin and corresponding 2-sided 95% CI were calculated.||2.3|-2.4|
72349199|NCT01200368|144219107|SUPERIORITY_OR_OTHER||GMC ratio|1.1|||||TWO_SIDED|95.0|0.97|1.24||||||GMC ratio for diphtheria toxoid and corresponding 2-sided 95% CI were calculated.||1.24|0.97|
72349200|NCT01200368|144219107|SUPERIORITY_OR_OTHER||GMC ratio|0.9|||||TWO_SIDED|95.0|0.77|1.06||||||GMC ratio for tetanus toxoid and corresponding 2-sided 95% CI were calculated.||1.06|0.77|
72429135|NCT01474512|144369232|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||LS mean and P-value were calculated using MMRM with baseline score as a covariate, treatment, geographic region, previous non-biologic systemic therapy, baseline weight category, visit and treatment-by-visit interaction as fixed effects.|Mixed Models Analysis|||||||<0.001
72429136|NCT01474512|144369232|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||LS mean and P-value were calculated using MMRM with baseline score as a covariate, treatment, geographic region, previous non-biologic systemic therapy, baseline weight category, visit and treatment-by-visit interaction as fixed effects.|Mixed Models Analysis|||||||<0.001
72429137|NCT01474512|144369233|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||The LS Mean and p-values were calculated using an ANCOVA model and included treatment, geographic region, previous non-biologic systemic therapy, baseline weight category, and baseline WPAI value.|ANCOVA|P-value is for Absenteeism.||||||<0.001
72429138|NCT01474512|144369233|SUPERIORITY_OR_OTHER_LEGACY|||||||0.003|TWO_SIDED|||||The LS Mean and p-values were calculated using an ANCOVA model and included treatment, geographic region, previous non-biologic systemic therapy, baseline weight category, and baseline WPAI value.|ANCOVA|P-value is for absenteeism.||||||0.003
72349201|NCT01200368|144219108|SUPERIORITY_OR_OTHER||GMC ratio|0.98|||||TWO_SIDED|95.0|0.87|1.1||||||GMC ratio for pertussis toxoid and corresponding 2-sided 95% CI were calculated.||1.10|0.87|
72349202|NCT01200368|144219108|SUPERIORITY_OR_OTHER||GMC ratio|0.92|||||TWO_SIDED|95.0|0.81|1.05||||||GMC ratio for filamentous hemagglutinin and corresponding 2-sided 95% CI were calculated.||1.05|0.81|
72349203|NCT01200368|144219109|SUPERIORITY_OR_OTHER||GMC ratio|1.01|||||TWO_SIDED|95.0|0.88|1.15||||||GMC ratio for diphtheria toxoid and corresponding 2-sided 95% CI were calculated.||1.15|0.88|
72349204|NCT01200368|144219109|SUPERIORITY_OR_OTHER||GMC ratio|1.0|||||TWO_SIDED|95.0|0.85|1.19||||||GMC ratio for tetanus toxoid and corresponding 2-sided 95% CI were calculated.||1.19|0.85|
72349205|NCT01200368|144219110|SUPERIORITY_OR_OTHER||GMC ratio|0.96|||||TWO_SIDED|95.0|0.84|1.11||||||GMC ratio for pertussis toxoid and corresponding 2-sided 95% CI were calculated.||1.11|0.84|
72349206|NCT01200368|144219110|SUPERIORITY_OR_OTHER||GMC ratio|0.8|||||TWO_SIDED|95.0|0.7|0.91||||||GMC ratio for filamentous hemagglutinin and corresponding 2-sided 95% CI were calculated.||0.91|0.70|
72349207|NCT00108862|144219119|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.0|STANDARD_ERROR_OF_MEAN|3.0||0.45|TWO_SIDED|95.08|-2.0|8.0||The analysis was stratified by screening CD4 (\<50 cells/mm3 vs =\>50). Interim reviews employed group sequential monitoring using an O'Brien-Fleming use function. At final analysis, the a priori threshold for statistical significance was 0.0492.|Z-test, 2-sided|A 2-sided Z-test was used to compare the two percents. The test was weighted by the inverse of the Greenwood's variance in each CD4 stratum.|The difference in percents was calculated as the percent failed in the Deferred ART arm minus the percent failed in the Immediate ART arm.|Assuming that immediate ART was better than deferred ART and that the combined rate in the deferred ART arm was 25% compared to 15% in the immediate ART arm (a 40% reduction), and assuming 10% loss to follow-up in a two-sided, two-sample 0.05-level asymptotically-normal test with 400 participants in each arm, there was 90% power. The percents tested were Kaplan-Meier estimators at week 48 with the associated Greenwood's variance.||8|-2|0.45
72349208|NCT00108862|144219120|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.0|STANDARD_ERROR_OF_MEAN|5.0||0.02|TWO_SIDED|95.08|2.0|21.0||Interim reviews employed group sequential monitoring using an\> O'Brien-Fleming use function. At final analysis, the a priori threshold for statistical significance was 0.0492.|Z-test, 2-sided||The difference in percents was calculated as the percent failed in the Deferred ART arm minus the percent failed in the Immediate ART arm.|The study was not powered for this pre-specified subgroup analysis.||21|2|0.02
72349209|NCT00108862|144219121|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0|STANDARD_ERROR_OF_MEAN|3.0||0.67|TWO_SIDED|95.08|-7.0|4.0||Interim reviews employed group sequential monitoring using an O'Brien-Fleming use function. At final analysis, the a priori threshold for statistical significance was 0.0492.|Z-test, 2-sided||The difference in percents was calculated as the percent failed in the Deferred ART arm minus the percent failed in the Immediate ART arm.|The study was not powered for this pre-specified subgroup analysis.||4|-7|0.67
72349210|NCT00632619|144219141|SUPERIORITY_OR_OTHER|||||||0.106|||||||ANOVA|||A 2 x 2 repeated measures analysis (with time as within-subject factor and group as between-subject factor) was performed to compare the two groups on this measure at two time points (i.e., baseline at week 0 and endpoint at week 12) and infer treatment success accordingly. The null hypothesis signified that there would be no difference between the groups over time, thus, there would be no difference in treatments. Statistical power was calculated as Cohen's d.||||0.106
72349211|NCT00632619|144219142|SUPERIORITY_OR_OTHER|||||||0.015|||||||ANOVA|||A 2 x 2 repeated measures analysis (with time as within-subject factor and group as between-subject factor) was performed to compare the two groups on this measure at two time points (i.e., baseline which was week 0 and endpoint at week 12) and infer treatment success accordingly. The null hypothesis signified that there would be no difference between the groups over time, thus, there would be no difference in treatments. Statistical power was calculated as Cohen's d.||||0.015
72349212|NCT00632619|144219143|SUPERIORITY_OR_OTHER|||||||0.38||95.0|||||ANOVA|||A 2 x 2 repeated measures analysis (with time as within-subject factor and group as between-subject factor) was conducted to compare the two groups on this measure at two time points (i.e., baseline at week 0 and endpoint at week 12) and infer treatment success accordingly. The null hypothesis signified that there would be no difference between the groups over time, thus, there would be no difference in treatments. Statistical power was calculated as Cohen's d.||||0.38
72349213|NCT00632619|144219144|SUPERIORITY_OR_OTHER|||||||0.016|||||||ANOVA|||A 2 x 2 repeated measures analysis (with time as within-subject factor and group as between-subject factor) was performed to compare the two groups on this measure at two time points (i.e., baseline at week 0 and endpoint at week 12) and infer treatment success accordingly. The null hypothesis signified that there would be no difference between the groups over time, thus, there would be no difference in treatments. Statistical power was calculated as Cohen's d.||||0.016
72349214|NCT00632619|144219145|SUPERIORITY_OR_OTHER|||||||0.095|||||||ANOVA|||A 2 x 2 repeated measures analysis (with time as within-subject factor and group as between-subject factor) was performed to compare the two groups on this measure at two time points (i.e., baseline at week 0 and endpoint at week 12) and infer treatment success accordingly. The null hypothesis signified that there would be no difference between the groups over time, thus, there would be no difference in treatments. Statistical power was calculated as Cohen's d.||||0.095
72349215|NCT00566852|144219146|SUPERIORITY_OR_OTHER|||||||0.059||||||Significance level was 0.025.|Wilcoxon (Mann-Whitney)|||Null hypothesis: patients on memantine will experience less decline than patients receiving placebo. Based on a one-sided Wilcoxon rank sum test with alpha=0.025, 221 patients per arm would be required to have 80% statistical power to detect a mean difference of 0.87 in the HVLT-R change scores between the two treatment arms. Assuming that 20% of patients may be ineligible, or die prior to the 24 week assessment, the target sample size for randomization was set to 536.||||0.059
72349216|NCT00566852|144219147|SUPERIORITY|||||||0.0692||||||One-sided significance level of 0.025|Wilcoxon (Mann-Whitney)|||8 weeks||||0.0692
72349217|NCT00566852|144219147|SUPERIORITY|||||||0.4541||||||One-sided significance level of 0.025|Wilcoxon (Mann-Whitney)|||16 weeks||||0.4541
72349218|NCT00566852|144219147|SUPERIORITY|||||||0.397||||||One-sided significance level of 0.025|Wilcoxon (Mann-Whitney)|||52 weeks||||0.3970
72349219|NCT00566852|144219148|SUPERIORITY||Hazard Ratio (HR)|0.78||||0.01|TWO_SIDED|95.0|0.62|0.99|||Gray's test|||A one-sided log-rank test with alpha 0.025 accruing 221 patients/arm with 12 months of follow-up would ensure 98% statistical power to detect a 33% relative reduction in the monthly hazard rate with the use of memantine. Gray's test was used to test for a statistically significant difference in the distribution of neurocognitive failure times and Cox proportional hazards regression model was used to determine hazard ratios and 95% confidence intervals for the treatment difference.||0.99|0.62|0.01
72349220|NCT00566852|144219149|SUPERIORITY|||||||0.77|||||||Wilcoxon (Mann-Whitney)|||Assuming normally distributions, the two sample t-test assuming equal variances would be used to compare the arms at the 0.025 significance level. If normality assumptions were not met, the Wilcoxon rank sum would be used.||||0.77
72349221|NCT00566852|144219150|SUPERIORITY||Hazard Ratio (HR)|1.06||||0.27|TWO_SIDED|95.0|0.87|1.3|||Log Rank|||The stratified log-rank test was used to test for a statistically significant difference in survival distributions with a one-sided alpha of 0.025 . In addition, the Cox proportional hazards regression model was used to determine hazard ratios and 95% confidence intervals for the treatment difference.||1.3|0.87|0.27
72349222|NCT00566852|144219151|SUPERIORITY||Hazard Ratio (HR)|1.06||||0.025|TWO_SIDED|95.0|0.86|1.31|||Log Rank|||The stratified log-rank test was used to test for a statistically significant difference in survival distributions with a one-sided alpha of 0.025 . In addition, the Cox proportional hazards regression model was used to determine hazard ratios and 95% confidence intervals for the treatment difference.||1.31|0.86|0.025
72349223|NCT00577824|144219154|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Bonferroni's method was used to adjustment for multiplicity, and significant level was set to 2.5%(two-sided).|ANCOVA|ANCOVA model with treatment group as a factor and baseline value as the covariate.||||||<0.001
72349224|NCT00577824|144219155|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Cochran-Armitage|||||||<0.001
72349225|NCT00577824|144219156|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Cochran-Armitage|||||||<0.001
72349226|NCT00577824|144219157|SUPERIORITY_OR_OTHER||||||<|0.002||95.0||||No adjustment for multiplicity. Significance level was 5% (two-sided).|ANCOVA|||||||<0.002
72349227|NCT00577824|144219158|SUPERIORITY_OR_OTHER|||||||0.026||95.0||||No adjustment for multiplicity. Significance level was 5% (two-sided).|ANCOVA|||||||0.026
72349228|NCT00577824|144219159|SUPERIORITY_OR_OTHER|||||||0.672||95.0|||||t-test, 2 sided|||||||0.672
72349229|NCT00577824|144219160|SUPERIORITY_OR_OTHER|||||||0.58||95.0|||||t-test, 2 sided|||||||0.580
72349230|NCT00577824|144219161|SUPERIORITY_OR_OTHER|||||||0.014||95.0|||||t-test, 2 sided|||||||0.014
72349231|NCT00577824|144219162|SUPERIORITY_OR_OTHER|||||||0.49||95.0|||||t-test, 2 sided|||||||0.490
72349232|NCT00577824|144219163|SUPERIORITY_OR_OTHER|||||||0.003||95.0|||||t-test, 2 sided|||||||0.003
72349233|NCT00577824|144219164|SUPERIORITY_OR_OTHER|||||||0.208||95.0|||||t-test, 2 sided|||||||0.208
72349234|NCT00577824|144219166|SUPERIORITY_OR_OTHER|||||||0.708||95.0|||||t-test, 2 sided|||||||0.708
72349235|NCT00577824|144219167|SUPERIORITY_OR_OTHER|||||||0.974||95.0|||||t-test, 2 sided|||||||0.974
72349236|NCT00577824|144219169|SUPERIORITY_OR_OTHER|||||||0.2||95.0|||||t-test, 2 sided|||||||0.200
72349237|NCT00577824|144219170|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||||||<0.001
72349238|NCT01702246|144219204|SUPERIORITY_OR_OTHER|||||||0.005|TWO_SIDED|||||Wilcoxon matched pairs signed rank test|Wilcoxon (Mann-Whitney)|||||||0.005
72349239|NCT01702246|144219205|SUPERIORITY_OR_OTHER|||||||0.003|TWO_SIDED||||||t-test, 2 sided|||||||0.003
72349240|NCT01702246|144219206|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED||||||t-test, 2 sided|||||||0.001
72349241|NCT04607837|144219296|SUPERIORITY||Risk Difference (RD)|7.35||||0.2524|TWO_SIDED|95.0|-5.24|19.94|||Mantel Haenszel|||Difference (%) for etrasimod minus placebo was based on estimated common risk difference using the Mantel- Haenszel weights. The 2-sided p-value was used to test the hypothesis of the risk difference being 0.||19.94|-5.24|0.2524
72349242|NCT04607837|144219297|SUPERIORITY||Risk Difference (RD)|15.61||||0.0068|TWO_SIDED|95.0|4.31|26.91|||Mantel Haenszel|||Difference (%) for etrasimod minus placebo was based on estimated common RD using the Mantel- Haenszel weights. The 2-sided p-value was used to test the hypothesis of the RD being 0.||26.91|4.31|0.0068
72349243|NCT04607837|144219298|SUPERIORITY||Risk Difference (RD)|8.24||||0.2302|TWO_SIDED|95.0|-5.22|21.71|||Mantel Haenszel|||Difference (%) for etrasimod minus placebo was based on estimated common RD using the Mantel- Haenszel weights. The 2-sided p-value was used to test the hypothesis of the RD being 0.||21.71|-5.22|0.2302
72349244|NCT04607837|144219299|SUPERIORITY||Risk Difference (RD)|7.12||||0.3339|TWO_SIDED|95.0|-7.32|21.55|||Mantel Haenszel|||Difference (%) for etrasimod minus placebo was based on estimated common RD using the Mantel- Haenszel weights, where only participants with an assessment at Baseline and the corresponding visit are included. The 2-sided Nominal p-value was used to test the hypothesis of the RD being 0.||21.55|-7.32|0.3339
72349245|NCT04607837|144219300|SUPERIORITY||Risk Difference (RD)|0.68||||0.9141|TWO_SIDED|95.0|-11.76|13.13|||Mantel Haenszel|||Difference (%) for etrasimod minus placebo was based on estimated common RD using the Mantel- Haenszel weights, where only participants with an assessment at Baseline and the corresponding visit are included. The 2-sided Nominal p-value was used to test the hypothesis of the RD being 0.||13.13|-11.76|0.9141
72349246|NCT04607837|144219301|SUPERIORITY||Risk Difference (RD)|9.56||||0.1089|TWO_SIDED|95.0|-2.13|21.25|||Mantel Haenszel|||Difference (%) for etrasimod minus placebo was based on estimated common RD using the Mantel- Haenszel weights. The 2-sided p-value was used to test the hypothesis of the RD being 0.||21.25|-2.13|0.1089
72349247|NCT04607837|144219302|SUPERIORITY||Risk Difference (RD)|11.19||||0.0104|TWO_SIDED|95.0|2.63|19.75|||Mantel Haenszel|||Difference (%) for etrasimod minus placebo was based on estimated common RD using the Mantel- Haenszel weights. The 2-sided p-value was used to test the hypothesis of the RD being 0.||19.75|2.63|0.0104
72349248|NCT04607837|144219303|SUPERIORITY||Risk Difference (RD)|-1.07||||0.9203|TWO_SIDED|95.0|-22.06|19.92|||Mantel Haenszel|||Difference (%) for etrasimod minus placebo was based on estimated common RD using the Mantel- Haenszel weights. The 2-sided p-value was used to test the hypothesis of the RD being 0.||19.92|-22.06|0.9203
72349249|NCT04607837|144219304|SUPERIORITY||Risk Difference (RD)|8.49||||0.1726|TWO_SIDED|95.0|-3.71|20.68|||Mantel Haenszel|||Difference (%) for etrasimod minus placebo was based on estimated common RD using the Mantel- Haenszel weights. The 2-sided p-value was used to test the hypothesis of the RD being 0.||20.68|-3.71|0.1726
72349250|NCT04607837|144219305|SUPERIORITY||Risk Difference (RD)|-1.71||||0.9272|TWO_SIDED|95.0|-38.31|34.9|||Mantel Haenszel|||Difference (%) for etrasimod minus placebo was based on estimated common RD using the Mantel- Haenszel weights. The 2-sided p-value was used to test the hypothesis of the RD being 0.||34.90|-38.31|0.9272
72349251|NCT04607837|144219306|SUPERIORITY||Risk Difference (RD)|8.49||||0.1726|TWO_SIDED|95.0|-3.71|20.68|||Mantel Haenszel|||Difference (%) for etrasimod minus placebo was based on estimated common RD using the Mantel- Haenszel weights. The 2-sided p-value was used to test the hypothesis of the RD being 0.||20.68|-3.71|0.1726
72349252|NCT04607837|144219307|SUPERIORITY||Risk Difference (RD)|18.64||||0.0151|TWO_SIDED|95.0|3.61|33.67|||Mantel Haenszel|||Difference (%) for etrasimod minus placebo was based on estimated common RD using the Mantel- Haenszel weights. The 2-sided p-value was used to test the hypothesis of the RD being 0.||33.67|3.61|0.0151
72349253|NCT04607837|144219308|SUPERIORITY||Risk Difference (RD)|5.96||||0.4419|TWO_SIDED|95.0|-9.22|21.13|||Mantel Haenszel|||Difference (%) for etrasimod minus placebo was based on estimated common RD using the Mantel- Haenszel weights. The 2-sided p-value was used to test the hypothesis of the RD being 0.||21.13|-9.22|0.4419
72349254|NCT04607837|144219309|SUPERIORITY||Risk Difference (RD)|23.33||||0.0007|TWO_SIDED|95.0|9.78|36.89|||Mantel Haenszel|||Difference (%) for etrasimod minus placebo was based on estimated common RD using the Mantel- Haenszel weights. The 2-sided p-value was used to test the hypothesis of the RD being 0.||36.89|9.78|0.0007
72349255|NCT04607837|144219310|SUPERIORITY||Risk Difference (RD)|14.99||||0.0128|TWO_SIDED|95.0|3.19|26.79|||Mantel Haenszel|||Difference (%) for etrasimod minus placebo was based on estimated common RD using the Mantel- Haenszel weights. The 2-sided p-value was used to test the hypothesis of the RD being 0.||26.79|3.19|0.0128
72349256|NCT04607837|144219311|SUPERIORITY||Risk Difference (RD)|10.24||||0.1492|TWO_SIDED|95.0|-3.67|24.14|||Mantel Haenszel|||Difference (%) for etrasimod minus placebo was based on estimated common RD using the Mantel- Haenszel weights, where only participants with an assessment at Baseline and the corresponding visit are included. The 2-sided Nominal p-value was used to test the hypothesis of the RD being 0.||24.14|-3.67|0.1492
72349257|NCT04607837|144219312|SUPERIORITY||Risk Difference (RD)|0.18||||0.9774|TWO_SIDED|95.0|-12.18|12.53|||Mantel Haenszel|||Difference (%) for etrasimod minus placebo was based on estimated common RD using the Mantel- Haenszel weights, where only participants with an assessment at Baseline and the corresponding visit are included. The 2-sided Nominal p-value was used to test the hypothesis of the RD being 0.||12.53|-12.18|0.9774
72349258|NCT04607837|144219313|SUPERIORITY||Risk Difference (RD)|22.83||||0.0011|TWO_SIDED|95.0|9.17|36.49|||Mantel Haenszel|||Difference (%) for etrasimod minus placebo was based on estimated common RD using the Mantel- Haenszel weights, where only participants with an assessment at Baseline and the corresponding visit are included. The 2-sided Nominal p-value was used to test the hypothesis of the RD being 0.||36.49|9.17|0.0011
72349259|NCT04607837|144219314|SUPERIORITY||Risk Difference (RD)|10.8||||0.1513|TWO_SIDED|95.0|-3.95|25.56|||Mantel Haenszel|||Difference (%) for etrasimod minus placebo was based on estimated common RD using the Mantel- Haenszel weights, where only participants with an assessment at Baseline and the corresponding visit are included. The 2-sided Nominal p-value was used to test the hypothesis of the RD being 0.||25.56|-3.95|0.1513
72349260|NCT04607837|144219315|SUPERIORITY||Risk Difference (RD)|10.07||||0.1823|TWO_SIDED|95.0|-4.73|24.87|||Mantel Haenszel|||Difference (%) for etrasimod minus placebo was based on estimated common RD using the Mantel- Haenszel weights, where only participants with an assessment at Baseline and the corresponding visit are included. The 2-sided Nominal p-value was used to test the hypothesis of the RD being 0.||24.87|-4.73|0.1823
72349261|NCT02123823|144219488|OTHER||Hazard Ratio, log|0.97||||0.9057|TWO_SIDED|95.0|0.57|1.65|||Log Rank|Two-sided log-rank test stratified for visceral involvement.|Cox proportional hazards model stratified for visceral involvement.|||1.65|0.57|0.9057
72349262|NCT02123823|144219491|OTHER||Odds Ratio, log|0.7||||0.5598|TWO_SIDED|95.0|0.2|2.32|||Regression, Logistic|Odds ratio and p-value are obtained from logistic regression model adjusted for visceral involvement at screening.|An odds ratio \>1 indicates a benefit to the xentuzumab arm.|||2.32|0.20|0.5598
72349263|NCT02123823|144219492|OTHER||Hazard Ratio, log|1.03||||0.9146|TWO_SIDED|95.0|0.59|1.8|||Log Rank|Two-sided log-rank test stratified for visceral involvement.|Cox proportional hazards model stratified for visceral involvement.|||1.80|0.59|0.9146
72349264|NCT02123823|144219493|OTHER||Odds Ratio, log|0.7||||0.4008|TWO_SIDED|95.0|0.31|1.59|||Regression, Logistic|Odds ratio and p-value are obtained from logistic regression model adjusted for visceral involvement.|An odds ratio \>1 indicates a benefit to the xentuzumab arm.|||1.59|0.31|0.4008
72349265|NCT03453489|144219498|OTHER|||||||0.837|||||||t-test, 2 sided|||||||0.837
72349266|NCT04346654|144219501|SUPERIORITY|||||||0.5133|||||||Regression, Logistic|||||||0.5133
72349267|NCT04346654|144219502|SUPERIORITY|||||||0.5133|||||||Regression, Logistic|||||||0.5133
72349268|NCT05870865|144219520|SUPERIORITY||Mean Difference (Final Values)|4.28||||0.5483|TWO_SIDED||||||Mixed Models Analysis|||||||0.5483
72349269|NCT05870865|144219520|SUPERIORITY||Mean Difference (Final Values)|-5.89||||0.4123|TWO_SIDED||||||Mixed Models Analysis|||||||0.4123
72349270|NCT05870865|144219520|SUPERIORITY||Mean Difference (Final Values)|1.66||||0.8177|TWO_SIDED||||||Mixed Models Analysis|||||||0.8177
72349271|NCT05870865|144219521|SUPERIORITY||Odds Ratio (OR)|0.66||||0.4601|TWO_SIDED||||||Fisher Exact|||||||0.4601
72349272|NCT05870865|144219521|SUPERIORITY||Odds Ratio (OR)|2.64||||0.0804|TWO_SIDED||||||Fisher Exact|||||||0.0804
72349273|NCT05870865|144219521|SUPERIORITY||Odds Ratio (OR)|1.06|||>|0.9999|TWO_SIDED||||||Fisher Exact|||||||>0.9999
72349274|NCT05870865|144219522|SUPERIORITY||Mean Difference (Final Values)|0.72||||0.2146|TWO_SIDED||||||Mixed Models Analysis|||||||0.2146
72349275|NCT05870865|144219522|SUPERIORITY||Mean Difference (Final Values)|-0.09||||0.8851|TWO_SIDED||||||Mixed Models Analysis|||||||0.8851
72349276|NCT05870865|144219522|SUPERIORITY||Mean Difference (Final Values)|0.81||||0.1835|TWO_SIDED||||||Mixed Models Analysis|||||||0.1835
72349277|NCT05870865|144219523|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.7982|TWO_SIDED||||||Mixed Models Analysis|||||||0.7982
72349278|NCT05870865|144219523|SUPERIORITY||Mean Difference (Final Values)|-0.5||||0.564|TWO_SIDED||||||Mixed Models Analysis|||||||0.5640
72349279|NCT05870865|144219523|SUPERIORITY||Mean Difference (Final Values)|0.9||||0.2939|TWO_SIDED||||||Mixed Models Analysis|||||||0.2939
72429139|NCT01474512|144369233|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||The LS Mean and p-values were calculated using an ANCOVA model and included treatment, geographic region, previous non-biologic systemic therapy, baseline weight category, and baseline WPAI value.|ANCOVA|P-value is for activity impairment.||||||<0.001
72349280|NCT05870865|144219524|SUPERIORITY||Mean Difference (Final Values)|1.4||||0.3579|TWO_SIDED||||||Mixed Models Analysis|||||||0.3579
72349281|NCT05870865|144219524|SUPERIORITY||Mean Difference (Final Values)|-1.4||||0.3466|TWO_SIDED||||||Mixed Models Analysis|||||||0.3466
72349282|NCT05870865|144219524|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.9527|TWO_SIDED||||||Mixed Models Analysis|||||||0.9527
72349283|NCT02915978|144219542|OTHER||LS Mean Difference|-1.8|STANDARD_ERROR_OF_MEAN|0.89||0.0505|TWO_SIDED|95.0|-3.61|0.0|||ANCOVA|||NRS PID at 1 hour||0.00|-3.61|0.0505
72349284|NCT02915978|144219542|OTHER||LS Mean Difference|-1.06|STANDARD_ERROR_OF_MEAN|0.9||0.2493|TWO_SIDED|95.0|-2.89|0.77|||ANCOVA|||NRS PID at 1 hour||0.77|-2.89|0.2493
72349285|NCT02915978|144219542|OTHER||LS Mean Difference|-2.94|STANDARD_ERROR_OF_MEAN|0.99||0.0052|TWO_SIDED|95.0|-4.95|-0.94|||ANCOVA|||NRS PID at 16 hours||-0.94|-4.95|0.0052
72349286|NCT02915978|144219542|OTHER||LS Mean Difference|-1.67|STANDARD_ERROR_OF_MEAN|0.97||0.0926|TWO_SIDED|95.0|-3.62|0.29|||ANCOVA|||NRS PID at 16 hours||0.29|-3.62|0.0926
72349287|NCT02915978|144219542|OTHER||LS Means Difference|-1.4|STANDARD_ERROR_OF_MEAN|0.82||0.0951|TWO_SIDED|95.0|-3.06|0.26|||ANCOVA|||NRS PID at 24 hours||0.26|-3.06|0.0951
72349288|NCT02915978|144219542|OTHER||LS Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.8||0.9866|TWO_SIDED|95.0|-1.6|1.63|||ANCOVA|||NRS PID at 24 hours||1.63|-1.60|0.9866
72349289|NCT02343406|144219570|OTHER||Cox Proportional Hazard|0.71|||=|0.062|TWO_SIDED|95.0|0.5|1.02||2-sided|Log Rank|||Stratified at randomization by regions of the world (North America, Europe and Australia, Asia/Other Regions), WHO performance status (0, \> 0), timing of relapse (\< 16 weeks, ≥ 16 weeks after first day of last TMZ cycle).||1.02|0.5|= 0.062
72349290|NCT02343406|144219570|OTHER||Cox Proportional Hazard|1.04|||=|0.835|TWO_SIDED|95.0|0.73|1.48||2-sided|Log Rank|||Stratified at randomization by regions of the world (North America, Europe and Australia, Asia/Other Regions), WHO performance status (0, \> 0), timing of relapse (\< 16 weeks, ≥ 16 weeks after first day of last TMZ cycle).||1.48|0.73|= 0.835
72349291|NCT02343406|144219571|OTHER||Cox Proportional Hazard|0.77|||=|0.123|TWO_SIDED|95.0|0.55|1.07||2-sided|Log Rank|||||1.07|0.55|= 0.123
72349292|NCT02343406|144219571|OTHER||Cox Proportional Hazard|1.31|||=|0.117|TWO_SIDED|95.0|0.93|1.84||2-sided|Log Rank|||||1.84|0.93|= 0.117
72349293|NCT02343406|144219579|OTHER||Odds Ratio (OR)|3.1|||=|0.06|TWO_SIDED|95.0|0.6|16.16||2-sided|Cochran-Mantel-Haenszel|||Comparison is based on Cochran-Mantel-Haenszel method with stratification factors. Stratified at randomization by regions of the world (North America, Europe and Australia, Asia/Other Regions), WHO performance status (0, \> 0), timing of relapse (\< 16 weeks, ≥ 16 weeks after first day of last TMZ cycle).||16.16|0.6|= 0.06
72349294|NCT02343406|144219579|OTHER||Odds Ratio (OR)|1.21|||=|0.767|TWO_SIDED|95.0|0.12|12.49||2-sided|Cochran-Mantel-Haenszel|||Comparison is based on Cochran-Mantel-Haenszel method with stratification factors. Stratified at randomization by regions of the world (North America, Europe and Australia, Asia/Other Regions), WHO performance status (0, \> 0), timing of relapse (\< 16 weeks, ≥ 16 weeks after first day of last TMZ cycle).||12.49|0.12|= 0.767
72349295|NCT02343406|144219580|OTHER||Cox Proportional Hazard|0.67|||=|0.127|TWO_SIDED|95.0|0.4|1.13||2-sided|Log Rank|||||1.13|0.4|= 0.127
72349296|NCT02343406|144219580|OTHER||Cox Proportional Hazard|0.88|||=|0.64|TWO_SIDED|95.0|0.52|1.49||2-sided|Log Rank|||||1.49|0.52|= 0.64
72349297|NCT00766051|144219596|SUPERIORITY_OR_OTHER||Mean Difference (Net)|8.0|STANDARD_ERROR_OF_MEAN|1.76|<|0.005|TWO_SIDED|95.0|5.0|11.0||The P value is not adjusted for multiple comparisons or for statistical significance|t-test, 2 sided|||The expected outcome was that infants in the intervention group would exhibit significantly less number of days to attain oral feeding.||11|5|<0.005
72349298|NCT00766051|144219597|SUPERIORITY_OR_OTHER||Slope|0.275|||<|0.01|||||||Mixed Models Analysis|This correlation is between the intervention groups' initial level of relaxation and final level of relaxation during the oral feeding period.||Pearson Correlation, 2-tailed||||< 0.01
72349299|NCT00766051|144219598|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.6|STANDARD_DEVIATION|5.2|<|0.02|ONE_SIDED|95.0||6.7|||t-test, 1 sided||An increase in this test scale score means more parent confidence.|"Parent pre-post one sided t test of parents' global confidence, measured parental confidence in feeding, handling, and interacting with their infant."||6.7||< .02
72349300|NCT00766051|144219599|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.8|STANDARD_DEVIATION|4.3|<|0.03|ONE_SIDED|95.0||4.54|||t-test, 1 sided||An increase in this test scale score means an increase in the parents' perception of their infants' easiness during caregiving.|Parent pre-post one sided t test on the Easiness Scale of the Mother and Baby Scales in how parents percieve their interactions (alert-responsiveness, mood) with their infant and infant sleep patterns .||4.54||< .03
72349301|NCT00195663|144219600|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical tests were performed in a hierarchical manner. If there was a statistically significant difference in favor of adalimumab + MTX combination treatment, the second primary analysis of the modified Total Sharp Score was to be performed.|Chi-squared, Corrected|||The study was powered to demonstrate the superiority of adalimumab + MTX combination therapy vs. MTX monotherapy in the proportion of subjects who achieved an ACR50 response at 52 weeks. Power calculations were based on 250 subjects in each group using a chi-squared test with a continuity correction and an alpha = 0.05 significance level. With 250 subjects in each group, a difference of 0.13 in response rates could be detected with 80% power.||||<0.001
72349302|NCT00195663|144219601|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon (Mann-Whitney)|||Statistical tests were performed in a hierarchical manner. If there was a statistically significant difference in favor of adalimumab + MTX combination treatment on the ACR50 response, the second primary analysis of modified TSS would be performed.||||<0.001
72349303|NCT00195663|144219602|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.001
72349304|NCT00195663|144219603|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||||||< 0.001
72349305|NCT00195663|144219604|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon (Mann-Whitney)|||||||< 0.001
72349306|NCT00195663|144219605|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||||||< 0.001
72349307|NCT00195663|144219606|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon (Mann-Whitney)|||||||< 0.001
72349308|NCT00195663|144219607|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||||||< 0.001
72349309|NCT00195663|144219608|SUPERIORITY_OR_OTHER|||||||0.5402||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.5402
72349310|NCT02058563|144219655|NON_INFERIORITY_OR_EQUIVALENCE|Criteria for the determination of non-inferiority for measles, mumps, and rubella viruses: Lower limit (LL) of the 2-sided 95% Confidence Interval (CI) on GMC ratio (INV\_MMR over COM\_MMR) was to be equal to or above 0.67 for anti-measles, anti-mumps, and anti rubella antibodies.|Adjusted GMC ratio|1.0|||||TWO_SIDED|95.0|0.91|1.11|||||Number of subjects in the INV-MMR Group and in the COM-MMR Group considered for calculating the adjusted GMC ratio, are respectively 432 and 435 and adjusted GMCs = 1790.2 (LL=1669.6;UL=1919.5) and 1781.5 (LL=1661.8;UL=1909.7) respectively|Non-inferiority of INV\_MMR vaccine to COM\_MMR vaccine in terms of Geometric Mean Concentration (GMCs) for anti measles, anti mumps and anti rubella antibodies at Day 42.The 95% CI for adjusted geometric mean concentrations (GMCs) and the adjusted GMC ratio were obtained using an ANCOVA model on the logarithm-transformed concentrations including the vaccine group (for adjusted GMC ratio) as fixed effect, gender, age and country groups as continuous effects and the pre-vaccination log-transformed||1.11|0.91|
72349311|NCT02058563|144219656|NON_INFERIORITY_OR_EQUIVALENCE|Criteria for the determination of non-inferiority for measles, mumps, and rubella viruses: Lower limit (LL) of the 2-sided 95% Confidence Interval (CI) on GMC ratio (INV\_MMR over COM\_MMR) was to be equal to or above 0.67 for anti-measles, anti-mumps, and anti rubella antibodies.|Adjusted GMC ratio|1.05|||||TWO_SIDED|95.0|0.96|1.16|||||Number of subjects in the INV-MMR Group and in the COM-MMR Group considered for calculating the adjusted GMC ratio, are respectively 432 and 435 and adjusted GMCs = 113.5 (LL=106.0;UL=121.6) and 107.8 (LL=100.7;UL=115.4) respectively.|Non-inferiority of INV\_MMR vaccine to COM\_MMR vaccine in terms of Geometric Mean Concentration (GMCs) for anti measles, anti mumps and anti rubella antibodies at Day 42.The 95% CI for adjusted geometric mean concentrations (GMCs) and the adjusted GMC ratio were obtained using an ANCOVA model on the logarithm-transformed concentrations including the vaccine group (for adjusted GMC ratio) as fixed effect, gender, age and country groups as continuous effects and the pre-vaccination log-transformed.||1.16|0.96|
72349312|NCT02058563|144219657|NON_INFERIORITY_OR_EQUIVALENCE|Criteria for the determination of non-inferiority for measles, mumps, and rubella viruses: Lower limit (LL) of the 2-sided 95% Confidence Interval (CI) on GMC ratio (INV\_MMR over COM\_MMR) was to be equal to or above 0.67 for anti-measles, anti-mumps, and anti rubella antibodies.|Adjusted GMC ratio|1.02|||||TWO_SIDED|95.0|0.93|1.11|||||Number of subjects in the INV-MMR Group and in the COM-MMR Group considered for calculating the adjusted GMC ratio, are respectively 432 and 435 and adjusted GMCs = 76.1 (LL=71.5;UL=81.0) and 74.6 (LL=70.2;UL=79.4) respectively.|Non-inferiority of INV\_MMR vaccine to COM\_MMR vaccine in terms of Geometric Mean Concentration (GMCs) for anti measles, anti mumps and anti rubella antibodies at Day 42.The 95% CI for adjusted geometric mean concentrations (GMCs) and the adjusted GMC ratio were obtained using an ANCOVA model on the logarithm-transformed concentrations including the vaccine group (for adjusted GMC ratio) as fixed effect, gender, age and country groups as continuous effects and the pre-vaccination log-transformed||1.11|0.93|
72349313|NCT01868477|144219683|OTHER|difference|Mean Difference (Final Values)|14.4|||||TWO_SIDED|95.0|-24.0|48.16||||||||48.16|-24.0|
72349314|NCT01340586|144219737|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.787|||||TWO_SIDED|90.0|0.616|1.006||||||Geometric Mean Ratio: ESRD Dose before hemodialysis over Normal Renal Function||1.006|0.616|
72349315|NCT01340586|144219737|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.904|||||TWO_SIDED|90.0|0.697|1.173||||||Geometric Mean Ratio: ESRD Dose after hemodialysis over Normal Renal Function||1.173|0.697|
72349316|NCT01340586|144219737|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.871|||||TWO_SIDED|90.0|0.723|1.049||||||Geometric Mean Ratio: ESRD Dose before hemodialysis over ESRD Dose after hemodialysis||1.049|0.723|
72349317|NCT01340586|144219739|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.187|||||TWO_SIDED|90.0|0.907|1.553||||||Geometric Mean Ratio: ESRD Dose before hemodialysis over Normal Renal Function||1.553|0.907|
72349318|NCT01340586|144219739|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.389|||||TWO_SIDED|90.0|1.097|1.758||||||Geometric Mean Ratio: ESRD Dose after hemodialysis over Normal Renal Function||1.758|1.097|
72349319|NCT01340586|144219739|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.855|||||TWO_SIDED|90.0|0.707|1.033||||||Geometric Mean Ratio: ESRD Dose before hemodialysis over ESRD Dose after hemodialysis||1.033|0.707|
72349320|NCT01340586|144219741|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.165|||||TWO_SIDED|90.0|0.88|1.543||||||Geometric Mean Ratio: ESRD Dose before hemodialysis over Normal Renal Function||1.543|0.880|
72349321|NCT01340586|144219741|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.357|||||TWO_SIDED|90.0|1.066|1.728||||||Geometric Mean Ratio: ESRD Dose after hemodialysis over Normal Renal Function||1.728|1.066|
72349322|NCT01340586|144219741|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.858|||||TWO_SIDED|90.0|0.707|1.042||||||Geometric Mean Ratio: ESRD Dose before hemodialysis over ESRD Dose after hemodialysis||1.042|0.707|
72349323|NCT03223337|144219763|OTHER||Ratio of Geometric Least Square(LS) Mean|1.9973|||||TWO_SIDED|90.0|1.1063|3.6057|||||Ratio of Geometric LS Mean for GSK1278863 (Moderate hepatic impairment participants versus Healthy participants) has been presented.|||3.6057|1.1063|
72349324|NCT03223337|144219763|OTHER||Ratio of Geometric LS Mean|1.6471|||||TWO_SIDED|90.0|1.1267|2.4079|||||Ratio of Geometric LS Mean for GSK2391220 (M2) (Moderate hepatic impairment participants versus Healthy participants) has been presented.|||2.4079|1.1267|
72349325|NCT03223337|144219763|OTHER||Ratio of Geometric LS Mean|1.6404|||||TWO_SIDED|90.0|1.0744|2.5048|||||Ratio of Geometric LS Mean for GSK2487818 (M4) (Moderate hepatic impairment participants versus Healthy participants) has been presented.|||2.5048|1.0744|
72349326|NCT03223337|144219763|OTHER||Ratio of Geometric LS Mean|1.4931|||||TWO_SIDED|90.0|1.0876|2.0498|||||Ratio of Geometric LS Mean for GSK2506102 (M5) (Moderate hepatic impairment participants versus Healthy participants) has been presented.|||2.0498|1.0876|
72349327|NCT03223337|144219763|OTHER||Ratio of Geometric LS Mean|1.6222|||||TWO_SIDED|90.0|1.1594|2.2696|||||Ratio of Geometric LS Mean for GSK2531398 (M6) (Moderate hepatic impairment participants versus Healthy participants) has been presented.|||2.2696|1.1594|
72349328|NCT03223337|144219763|OTHER||Ratio of Geometric LS Mean|1.3145|||||TWO_SIDED|90.0|0.9896|1.7462|||||Ratio of Geometric LS Mean for GSK2531401 (M13) (Moderate hepatic impairment participants versus Healthy participants) has been presented.|||1.7462|0.9896|
72349329|NCT03223337|144219764|OTHER||Ratio of Geometric LS Mean|1.4574|||||TWO_SIDED|90.0|1.035|2.0523|||||Ratio of Geometric LS Mean for GSK1278863 (Mild hepatic impairment participants versus Healthy participants) has been presented.|||2.0523|1.0350|
72349330|NCT03223337|144219764|OTHER||Ratio of Geometric LS Mean|1.9375|||||TWO_SIDED|90.0|1.3919|2.6968|||||Ratio of Geometric LS Mean for GSK2391220 (M2) (Mild hepatic impairment participants versus Healthy participants) has been presented.|||2.6968|1.3919|
72349331|NCT03223337|144219764|OTHER||Ratio of Geometric LS Mean|1.8312|||||TWO_SIDED|90.0|1.3342|2.5133|||||Ratio of Geometric LS Mean for GSK2506104 (M3) (Mild hepatic impairment participants versus Healthy participants) has been presented.|||2.5133|1.3342|
72349332|NCT03223337|144219764|OTHER||Ratio of Geometric LS Mean|2.003|||||TWO_SIDED|90.0|1.4654|2.7378|||||Ratio of Geometric LS Mean for GSK2487818 (M4) (Mild hepatic impairment participants versus Healthy participants) has been presented.|||2.7378|1.4654|
72349333|NCT03223337|144219764|OTHER||Ratio of Geometric LS Mean|1.7113|||||TWO_SIDED|90.0|1.2818|2.2847|||||Ratio of Geometric LS Mean for GSK2506102 (M5) (Mild hepatic impairment participants versus Healthy participants) has been presented.|||2.2847|1.2818|
72349334|NCT03223337|144219764|OTHER||Ratio of Geometric LS Mean|1.974|||||TWO_SIDED|90.0|1.5365|2.536|||||Ratio of Geometric LS Mean for GSK2531398 (M6) (Mild hepatic impairment participants versus Healthy participants) has been presented.|||2.5360|1.5365|
72349335|NCT03223337|144219764|OTHER||Ratio of Geometric LS Mean|1.4603|||||TWO_SIDED|90.0|0.9081|2.3484|||||Ratio of Geometric LS Mean for GSK2531401 (M13) (Mild hepatic impairment participants versus Healthy participants) has been presented.|||2.3484|0.9081|
72349336|NCT03223337|144219767|OTHER||Ratio of Geometric LS Mean|1.9973|||||TWO_SIDED|90.0|1.1061|3.6066|||||Ratio of Geometric LS Mean for GSK1278863 (Moderate hepatic impairment participants versus Healthy participants) has been presented.|||3.6066|1.1061|
72349337|NCT03223337|144219767|OTHER||Ratio of Geometric LS Mean|1.6509|||||TWO_SIDED|90.0|1.1285|2.415|||||Ratio of Geometric LS Mean for GSK2391220 (M2) (Moderate hepatic impairment participants versus Healthy participants) has been presented.|||2.4150|1.1285|
72349338|NCT03223337|144219767|OTHER||Ratio of Geometric LS Mean|1.6421|||||TWO_SIDED|90.0|1.0732|2.5125|||||Ratio of Geometric LS Mean for GSK2487818 (M4) (Moderate hepatic impairment participants versus Healthy participants) has been presented.|||2.5125|1.0732|
72349339|NCT03223337|144219767|OTHER||Ratio of Geometric LS Mean|1.5169|||||TWO_SIDED|90.0|1.0994|2.093|||||Ratio of Geometric LS Mean for GSK2506102 (M5) (Moderate hepatic impairment participants versus Healthy participants) has been presented.|||2.0930|1.0994|
72349340|NCT03223337|144219767|OTHER||Ratio of Geometric LS Mean|1.624|||||TWO_SIDED|90.0|1.1599|2.2736|||||Ratio of Geometric LS Mean for GSK2531398 (M6) (Moderate hepatic impairment participants versus Healthy participants) has been presented.|||2.2736|1.1599|
72349341|NCT03223337|144219767|OTHER||Ratio of Geometric LS Mean|1.3143|||||TWO_SIDED|90.0|0.9887|1.747|||||Ratio of Geometric LS Mean for GSK2531401 (M13) (Moderate hepatic impairment participants versus Healthy participants) has been presented.|||1.7470|0.9887|
72349342|NCT03223337|144219768|OTHER||Ratio of Geometric LS Mean|1.4566|||||TWO_SIDED|90.0|1.0344|2.0513|||||Ratio of Geometric LS Mean for GSK1278863 (Mild hepatic impairment participants versus Healthy participants) has been presented.|||2.0513|1.0344|
72349343|NCT03223337|144219768|OTHER||Ratio of Geometric LS Mean|1.9478|||||TWO_SIDED|90.0|1.3935|2.7224|||||Ratio of Geometric LS Mean for GSK2391220 (M2) (Mild hepatic impairment participants versus Healthy participants) has been presented.|||2.7224|1.3935|
72349344|NCT03223337|144219768|OTHER||Ratio of Geometric LS Mean|1.8392|||||TWO_SIDED|90.0|1.335|2.534|||||Ratio of Geometric LS Mean for GSK2506104 (M3) (Mild hepatic impairment participants versus Healthy participants) has been presented.|||2.5340|1.3350|
72349345|NCT03223337|144219768|OTHER||Ratio of Geometric LS Mean|2.0161|||||TWO_SIDED|90.0|1.4711|2.763|||||Ratio of Geometric LS Mean for GSK2487818 (M4) (Mild hepatic impairment participants versus Healthy participants) has been presented.|||2.7630|1.4711|
72349346|NCT03223337|144219768|OTHER||Ratio of Geometric LS Mean|1.7303|||||TWO_SIDED|90.0|1.2932|2.3151|||||Ratio of Geometric LS Mean for GSK2506102 (M5) (Mild hepatic impairment participants versus Healthy participants) has been presented.|||2.3151|1.2932|
72349347|NCT03223337|144219768|OTHER||Ratio of Geometric LS Mean|1.987|||||TWO_SIDED|90.0|1.5426|2.5594|||||Ratio of Geometric LS Mean for GSK2531398 (M6) (Mild hepatic impairment participants versus Healthy participants) has been presented.|||2.5594|1.5426|
72349348|NCT03223337|144219768|OTHER||Ratio of Geometric LS Mean|1.4646|||||TWO_SIDED|90.0|0.9086|2.3609|||||Ratio of Geometric LS Mean for GSK2531401 (M13) (Mild hepatic impairment participants versus Healthy participants) has been presented.|||2.3609|0.9086|
72349349|NCT03223337|144219769|OTHER||Ratio of Geometric LS Mean|1.9786|||||TWO_SIDED|90.0|1.0557|3.7084|||||Ratio of Geometric LS Mean for GSK1278863 (Moderate hepatic impairment participants versus Healthy participants) has been presented.|||3.7084|1.0557|
72349350|NCT03223337|144219769|OTHER||Ratio of Geometric LS Mean|1.2791|||||TWO_SIDED|90.0|0.9241|1.7705|||||Ratio of Geometric LS Mean for GSK2391220 (M2) (Moderate hepatic impairment participants versus Healthy participants) has been presented.|||1.7705|0.9241|
72349351|NCT03223337|144219769|OTHER||Ratio of Geometric LS Mean|1.2487|||||TWO_SIDED|90.0|0.8675|1.7974|||||Ratio of Geometric LS Mean for GSK2487818 (M4) (Moderate hepatic impairment participants versus Healthy participants) has been presented.|||1.7974|0.8675|
72349352|NCT03223337|144219769|OTHER||Ratio of Geometric LS Mean|1.1802|||||TWO_SIDED|90.0|0.9165|1.5197|||||Ratio of Geometric LS Mean for GSK2506102 (M5) (Moderate hepatic impairment participants versus Healthy participants) has been presented.|||1.5197|0.9165|
72349353|NCT03223337|144219769|OTHER||Ratio of Geometric LS Mean|1.2726|||||TWO_SIDED|90.0|0.952|1.7012|||||Ratio of Geometric LS Mean for GSK2531398 (M6) (Moderate hepatic impairment participants versus Healthy participants) has been presented.|||1.7012|0.9520|
72349354|NCT03223337|144219769|OTHER||Ratio of Geometric LS Mean|1.0409|||||TWO_SIDED|90.0|0.7927|1.3668|||||Ratio of Geometric LS Mean for GSK2531401 (M13) (Moderate hepatic impairment participants versus Healthy participants) has been presented.|||1.3668|0.7927|
72349355|NCT03223337|144219770|OTHER||Ratio of Geometric LS Mean|1.0097|||||TWO_SIDED|90.0|0.7122|1.4316|||||Ratio of Geometric LS Mean for GSK1278863 (Mild hepatic impairment participants versus Healthy participants) has been presented.|||1.4316|0.7122|
72349356|NCT03223337|144219770|OTHER||Ratio of Geometric LS Mean|1.7852|||||TWO_SIDED|90.0|1.2498|2.5498|||||Ratio of Geometric LS Mean for GSK2391220 (M2) (Mild hepatic impairment participants versus Healthy participants) has been presented.|||2.5498|1.2498|
72349357|NCT03223337|144219770|OTHER||Ratio of Geometric LS Mean|1.7337|||||TWO_SIDED|90.0|1.2343|2.4353|||||Ratio of Geometric LS Mean for GSK2506104 (M3) (Mild hepatic impairment participants versus Healthy participants) has been presented.|||2.4353|1.2343|
72349358|NCT03223337|144219770|OTHER||Ratio of Geometric LS Mean|1.7628|||||TWO_SIDED|90.0|1.2898|2.4092|||||Ratio of Geometric LS Mean for GSK2487818 (M4) (Mild hepatic impairment participants versus Healthy participants) has been presented.|||2.4092|1.2898|
72429140|NCT01474512|144369233|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||The LS Mean and p-values were calculated using an ANCOVA model and included treatment, geographic region, previous non-biologic systemic therapy, baseline weight category, and baseline WPAI value.|ANCOVA|P-value is for activity impairment.||||||<0.001
72429141|NCT01474512|144369233|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||The LS Mean and p-values were calculated using an ANCOVA model and included treatment, geographic region, previous non-biologic systemic therapy, baseline weight category, and baseline WPAI value.|ANCOVA|P-value is for presenteeism.||||||<0.001
72429142|NCT01474512|144369233|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||The LS Mean and p-values were calculated using an ANCOVA model and included treatment, geographic region, previous non-biologic systemic therapy, baseline weight category, and baseline WPAI value.|ANCOVA|P-value is for presenteeism.||||||<0.001
72349359|NCT03223337|144219770|OTHER||Ratio of Geometric LS Mean|1.6413|||||TWO_SIDED|90.0|1.2055|2.2347|||||Ratio of Geometric LS Mean for GSK2506102 (M5) (Mild hepatic impairment participants versus Healthy participants) has been presented.|||2.2347|1.2055|
72349360|NCT03223337|144219770|OTHER||Ratio of Geometric LS Mean|1.8289|||||TWO_SIDED|90.0|1.3992|2.3904|||||Ratio of Geometric LS Mean for GSK2531398 (M6) (Mild hepatic impairment participants versus Healthy participants) has been presented.|||2.3904|1.3992|
72349361|NCT03223337|144219770|OTHER||Ratio of Geometric LS Mean|1.3367|||||TWO_SIDED|90.0|0.8288|2.1557|||||Ratio of Geometric LS Mean for GSK2531401 (M13) (Mild hepatic impairment participants versus Healthy participants) has been presented.|||2.1557|0.8288|
72349362|NCT03223337|144219771|OTHER||Ratio of Geometric LS Mean|0.905|||||TWO_SIDED|90.0|0.69|1.1869|||||Ratio of Geometric LS Mean for GSK1278863 (Moderate hepatic impairment participants versus Healthy participants) has been presented.|||1.1869|0.6900|
72349363|NCT03223337|144219771|OTHER||Ratio of Geometric LS Mean|0.7415|||||TWO_SIDED|90.0|0.5617|0.9787|||||Ratio of Geometric LS Mean for GSK2391220 (M2) (Moderate hepatic impairment participants versus Healthy participants) has been presented.|||0.9787|0.5617|
72349364|NCT03223337|144219771|OTHER||Ratio of Geometric LS Mean|0.7299|||||TWO_SIDED|90.0|0.4387|1.2145|||||Ratio of Geometric LS Mean for GSK2487818 (M4) (Moderate hepatic impairment participants versus Healthy participants) has been presented.|||1.2145|0.4387|
72349365|NCT03223337|144219771|OTHER||Ratio of Geometric LS Mean|1.1703|||||TWO_SIDED|90.0|0.9|1.5219|||||Ratio of Geometric LS Mean for GSK2506102 (M5) (Moderate hepatic impairment participants versus Healthy participants) has been presented.|||1.5219|0.9000|
72349366|NCT03223337|144219771|OTHER||Ratio of Geometric LS Mean|0.9585|||||TWO_SIDED|90.0|0.6664|1.3786|||||Ratio of Geometric LS Mean for GSK2531398 (M6) (Moderate hepatic impairment participants versus Healthy participants) has been presented.|||1.3786|0.6664|
72349367|NCT03223337|144219771|OTHER||Ratio of Geometric LS Mean|1.0004|||||TWO_SIDED|90.0|0.7833|1.2778|||||Ratio of Geometric LS Mean for GSK2531401 (M13) (Moderate hepatic impairment participants versus Healthy participants) has been presented.|||1.2778|0.7833|
72349368|NCT03223337|144219772|OTHER||Ratio of Geometric LS Mean|1.0574|||||TWO_SIDED|90.0|0.7876|1.4197|||||Ratio of Geometric LS Mean for GSK1278863 (Mild hepatic impairment participants versus Healthy participants) has been presented.|||1.4197|0.7876|
72349369|NCT03223337|144219772|OTHER||Ratio of Geometric LS Mean|1.0143|||||TWO_SIDED|90.0|0.7332|1.4032|||||Ratio of Geometric LS Mean for GSK2391220 (M2) (Mild hepatic impairment participants versus Healthy participants) has been presented.|||1.4032|0.7332|
72349370|NCT03223337|144219772|OTHER||Ratio of Geometric LS Mean|1.038|||||TWO_SIDED|90.0|0.7695|1.4002|||||Ratio of Geometric LS Mean for GSK2506104 (M3) (Mild hepatic impairment participants versus Healthy participants) has been presented.|||1.4002|0.7695|
72349371|NCT03223337|144219772|OTHER||Ratio of Geometric LS Mean|1.3427|||||TWO_SIDED|90.0|0.7635|2.3615|||||Ratio of Geometric LS Mean for GSK2487818 (M4) (Mild hepatic impairment participants versus Healthy participants) has been presented.|||2.3615|0.7635|
72349372|NCT03223337|144219772|OTHER||Ratio of Geometric LS Mean|1.0296|||||TWO_SIDED|90.0|0.6996|1.5151|||||Ratio of Geometric LS Mean for GSK2506102 (M5) (Mild hepatic impairment participants versus Healthy participants) has been presented.|||1.5151|0.6996|
72349373|NCT03223337|144219772|OTHER||Ratio of Geometric LS Mean|1.2721|||||TWO_SIDED|90.0|0.8409|1.9245|||||Ratio of Geometric LS Mean for GSK2531398 (M6) (Mild hepatic impairment participants versus Healthy participants) has been presented.|||1.9245|0.8409|
72349374|NCT03223337|144219772|OTHER||Ratio of Geometric LS Mean|1.2072|||||TWO_SIDED|90.0|0.9398|1.5508|||||Ratio of Geometric LS Mean for GSK2531401 (M13) (Mild hepatic impairment participants versus Healthy participants) has been presented.|||1.5508|0.9398|
72349375|NCT03223337|144219773|OTHER||Median Difference (Final Values)|0.0||||0.6822|TWO_SIDED|90.0|-1.0|0.5||P-value was based on Mann-Whitney U test (exact Wilcoxon rank sum test).|Wilcoxon (Mann-Whitney)||Median Difference in GSK1278863 (Moderate hepatic impairment participants versus Healthy participants) has been presented.|||0.50|-1.00|0.6822
72349376|NCT03223337|144219773|OTHER||Median Difference (Final Values)|0.0||||0.5767|TWO_SIDED|90.0|-1.0|1.0||P-value was based on Mann-Whitney U test (exact Wilcoxon rank sum test).|Wilcoxon (Mann-Whitney)||Median Difference in GSK2391220 (M2)(Moderate hepatic impairment participants versus Healthy participants) has been presented.|||1.00|-1.00|0.5767
72349377|NCT03223337|144219773|OTHER||Median Difference (Final Values)|0.0||||0.588|TWO_SIDED|90.0|-1.0|1.5||P-value was based on Mann-Whitney U test (exact Wilcoxon rank sum test).|Wilcoxon (Mann-Whitney)||Median Difference in GSK2487818 (M4)(Moderate hepatic impairment participants versus Healthy participants) has been presented.|||1.50|-1.00|0.5880
72349378|NCT03223337|144219773|OTHER||Median Difference (Final Values)|0.0||||0.7716|TWO_SIDED|90.0|-1.0|1.0||P-value was based on Mann-Whitney U test (exact Wilcoxon rank sum test).|Wilcoxon (Mann-Whitney)||Median Difference in GSK2506102 (M5)(Moderate hepatic impairment participants versus Healthy participants) has been presented.|||1.00|-1.00|0.7716
72349379|NCT03223337|144219773|OTHER||Median Difference (Final Values)|0.5||||0.4093|TWO_SIDED|90.0|-1.0|2.0||P-value was based on Mann-Whitney U test (exact Wilcoxon rank sum test).|Wilcoxon (Mann-Whitney)||Median Difference in GSK2531398 (M6) (Moderate hepatic impairment participants versus Healthy participants) has been presented.|||2.00|-1.00|0.4093
72349380|NCT03223337|144219773|OTHER||Median Difference (Final Values)|0.0||||0.9837|TWO_SIDED|90.0|-1.0|1.0||P-value was based on Mann-Whitney U test (exact Wilcoxon rank sum test).|Wilcoxon (Mann-Whitney)||Median Difference in GSK2531401 (M13) (Moderate hepatic impairment participants versus Healthy participants) has been presented.|||1.00|-1.00|0.9837
72349381|NCT03223337|144219774|OTHER||Median Difference (Final Values)|0.0||||0.6224|TWO_SIDED|90.0|-1.0|0.5||P-value was based on Mann-Whitney U test (exact Wilcoxon rank sum test).|Wilcoxon (Mann-Whitney)||Median Difference in GSK1278863 (Mild hepatic impairment participants versus Healthy participants) has been presented.|||0.50|-1.00|0.6224
72349382|NCT03223337|144219774|OTHER||Median Difference (Final Values)|0.0||||0.8042|TWO_SIDED|90.0|-1.0|0.0||P-value was based on Mann-Whitney U test (exact Wilcoxon rank sum test).|Wilcoxon (Mann-Whitney)||Median Difference in GSK2391220 (M2) (Mild hepatic impairment participants versus Healthy participants) has been presented.|||0.00|-1.00|0.8042
72349383|NCT03223337|144219774|OTHER||Median Difference (Final Values)|0.0||||0.8423|TWO_SIDED|90.0|-1.0|1.0||P-value was based on Mann-Whitney U test (exact Wilcoxon rank sum test).|Wilcoxon (Mann-Whitney)||Median Difference in GSK2506104 (M3) (Mild hepatic impairment participants versus Healthy participants) has been presented.|||1.00|-1.00|0.8423
72349384|NCT03223337|144219774|OTHER||Median Difference (Final Values)|0.0||||0.5207|TWO_SIDED|90.0|-1.0|1.0||P-value was based on Mann-Whitney U test (exact Wilcoxon rank sum test).|Wilcoxon (Mann-Whitney)||Median Difference in GSK2487818 (M4) (Mild hepatic impairment participants versus Healthy participants) has been presented.|||1.00|-1.00|0.5207
72349385|NCT03223337|144219774|OTHER||Median Difference (Final Values)|0.0||||0.8423|TWO_SIDED|90.0|-1.0|1.0||P-value was based on Mann-Whitney U test (exact Wilcoxon rank sum test).|Wilcoxon (Mann-Whitney)||Median Difference in GSK2506102 (M5) (Mild hepatic impairment participants versus Healthy participants) has been presented.|||1.00|-1.00|0.8423
72429143|NCT01474512|144369233|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||The LS Mean and p-values were calculated using an ANCOVA model and included treatment, geographic region, previous non-biologic systemic therapy, baseline weight category, and baseline WPAI value.|ANCOVA|P-value is for work productively loss.||||||<0.001
72349386|NCT03223337|144219774|OTHER||Median Difference (Final Values)|0.0||||1|TWO_SIDED|90.0|-1.0|1.0||P-value was based on Mann-Whitney U test (exact Wilcoxon rank sum test).|Wilcoxon (Mann-Whitney)||Median Difference in GSK2531398 (M6) (Mild hepatic impairment participants versus Healthy participants) has been presented.|||1.00|-1.00|1.0000
72349387|NCT03223337|144219774|OTHER||Median Difference (Final Values)|0.0||||0.8042|TWO_SIDED|90.0|0.0|1.0||P-value was based on Mann-Whitney U test (exact Wilcoxon rank sum test).|Wilcoxon (Mann-Whitney)||Median Difference in GSK2531401 (M13) (Mild hepatic impairment participants versus Healthy participants) has been presented.|||1.00|0.00|0.8042
72349388|NCT01362608|144219796|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.69|||<|0.0001|TWO_SIDED|95.0|-28.2|-11.2|||ANCOVA|||||-11.2|-28.2|<0.0001
72349389|NCT01362608|144219797|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.26||||0.0043|TWO_SIDED|95.0|0.1|0.71|||Regression, Cox|||||0.71|0.10|0.0043
72349390|NCT01336140|144219812|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002|||||||Chi-squared|||"We calculated that a minimum of 248 subjects are needed to attain 80% power to detect 70% reduction in the incidence of the primary endpoint (diarrhea), assuming an event rate of 15% in the control group (2-tailed α = 0.05). We targeted enrolling 300 patients to allow some room for error in our assumptions.~null hypothesis: incidence of diarrhea is no different between the aminophylline arm and the placebo arm."||||0.002
72349391|NCT01336140|144219813|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||Chi-squared|||||||< 0.001
72349392|NCT01336140|144219814|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||< 0.001
72349393|NCT01336140|144219815|SUPERIORITY_OR_OTHER_LEGACY|||||||1|||||||Chi-squared|||||||1
72349394|NCT03526146|144219818|SUPERIORITY|||||||0.002|||||||paired t-test|||||||0.002
72349395|NCT03526146|144219819|SUPERIORITY|||||||0.047|||||||paired t-test|||||||0.047
72349396|NCT03526146|144219820|SUPERIORITY|||||||0.006|||||||paired t-test|||||||0.006
72349397|NCT03526146|144219821|SUPERIORITY|||||||0.05|||||||paired t-test|||||||0.05
72349398|NCT03526146|144219822|SUPERIORITY|||||||0.009|||||||paired t-test|||||||0.009
72349399|NCT02214290|144219823|OTHER||||||<|0.001|||||||ANOVA|post-hoc comparisons were used to determine within-group and between-group differences.||||||<0.001
72349400|NCT02214290|144219824|OTHER||||||<|0.001|||||||ANOVA|post-hoc comparisons were used to determine within-group and between-group differences.||||||<0.001
72349401|NCT02214290|144219825|OTHER||||||<|0.001|||||||ANOVA|post-hoc comparisons were used to determine within-group and between-group differences.||||||<0.001
72349402|NCT00699608|144219827|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.99||||0.267||95.0|-2.74|0.76|||ANCOVA|ANCOVA used (fixed effects: adjusted period baseline, participant baseline, age, gender, period and treatment group; random effect: participant).||||0.76|-2.74|0.267
72349403|NCT01510158|144219842|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.26|STANDARD_ERROR_OF_MEAN|0.05|<|0.0001|TWO_SIDED|95.0|0.17|0.36|||Cochran-Mantel-Haenszel|||||0.36|0.17|<0.0001
72349404|NCT01510158|144219842|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.31|STANDARD_ERROR_OF_MEAN|0.05|<|0.0001|TWO_SIDED|95.0|0.22|0.41|||Cochran-Mantel-Haenszel|||||0.41|0.22|<0.0001
72349405|NCT01510158|144219843|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.99||||0.9796|TWO_SIDED|95.0|0.61|1.61|||Negative Binomial Regression|||||1.61|0.61|0.9796
72349406|NCT01510158|144219843|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.88||||0.6125|TWO_SIDED|95.0|0.54|1.43|||Negative Binomial Regression|||||1.43|0.54|0.6125
72349407|NCT01510158|144219844|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.29||||0.0183|TWO_SIDED|95.0|-0.51|-0.08|||Cochran-Mantel-Haenszel|||||-0.08|-0.51|0.0183
72349408|NCT01510158|144219844|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.08||||0.5974|TWO_SIDED|95.0|-0.37|0.2|||Cochran-Mantel-Haenszel|||||0.2|-0.37|0.5974
72349409|NCT01013194|144219851|SUPERIORITY_OR_OTHER|||||||0.434|TWO_SIDED||||||Fisher Exact|||||||0.4340
72349410|NCT01013194|144219852|SUPERIORITY_OR_OTHER|||||||0.0076|TWO_SIDED||||||t-test, 2 sided|||Comparison at 1 year Follow-up||||0.0076
72349411|NCT01013194|144219853|SUPERIORITY_OR_OTHER|||||||0.0437|TWO_SIDED||||||t-test, 2 sided|||Comparison at 1 year Follow-up||||0.0437
72349412|NCT02588261|144219895|SUPERIORITY||Hazard Ratio (HR)|1.611||||0.992|TWO_SIDED|95.0|1.086|2.391|||Log Rank|||Comparison between ASP8273 and Erlotinib or Gefitinib treatment groups was performed using log-rank test stratified by ECOG (0 and 1 vs 2), EGFR mutation type (exon 19 deletion or exon 21 L858R) and TKI chosen by the site (erlotinib or gefitinib) before randomization. Comparison was tested at 1-sided significance level of 0.025. Hazard ratio based on Cox proportional hazards model. Assuming proportional hazards, HR \< 1 indicated a reduction in hazard rate in favor of ASP8273 treatment group.||2.391|1.086|0.992
72349413|NCT02588261|144219897|SUPERIORITY|||||||1|||||||Cochran-Mantel-Haenszel|||Comparison between ASP8273 and Erlotinib or Gefitinib treatment groups was performed using stratified Cochran-Mantel-Haenszel (CMH) test, stratified by ECOG (0 and 1 vs 2), EGFR mutation type (exon 19 deletion or exon 21 L858R) and TKI chosen by the site (erlotinib or gefitinib) before randomization. Comparison was tested at 1-sided significance level of 0.025.||||1.000
72349414|NCT02588261|144219898|SUPERIORITY||Hazard Ratio (HR)|1.674||||0.998|TWO_SIDED|95.0|1.165|2.406|||Log Rank|||Comparison between ASP8273 and Erlotinib or Gefitinib treatment groups was performed using log-rank test stratified by ECOG (0 and 1 vs 2), EGFR mutation type (exon 19 deletion or exon 21 L858R) and TKI chosen by the site (erlotinib or gefitinib) before randomization. Comparison was tested at 1-sided significance level of 0.025. Hazard ratio based on Cox proportional hazards model. Assuming proportional hazards, HR \< 1 indicated a reduction in hazard rate in favor of ASP8273 treatment group.||2.406|1.165|0.998
72349415|NCT02588261|144219899|SUPERIORITY|||||||0.839|||||||Cochran-Mantel-Haenszel|||Comparison between ASP8273 and Erlotinib or Gefitinib treatment groups was performed using stratified Cochran-Mantel-Haenszel (CMH) test, stratified by ECOG (0 and 1 vs 2), EGFR mutation type (exon 19 deletion or exon 21 L858R) and TKI chosen by the site (erlotinib or gefitinib) before randomization. Comparison was tested at 1-sided significance level of 0.025.||||0.839
72349416|NCT02588261|144219900|SUPERIORITY||Hazard Ratio (HR)|1.298||||0.78|TWO_SIDED|95.0|0.661|2.548|||Log Rank|||Comparison between ASP8273 and Erlotinib or Gefitinib treatment groups was performed using log-rank test stratified by ECOG (0 and 1 vs 2), EGFR mutation type (exon 19 deletion or exon 21 L858R) and TKI chosen by the site (erlotinib or gefitinib) before randomization. Comparison was tested at 1-sided significance level of 0.025. Hazard ratio based on Cox proportional hazards model. Assuming proportional hazards, HR \< 1 indicated a reduction in hazard rate in favor of ASP8273 treatment group.||2.548|0.661|0.780
72349417|NCT02287467|144219906|SUPERIORITY||Odds Ratio (OR)|1.25||||0.33|TWO_SIDED|95.0|0.79|1.97|||Regression, Logistic|Adjusted for baseline clinical status, region, and participation in the pilot study.|Odds ratio is hIVIG vs. placebo. A value greater than 1 favors the hIVIG group.|Odds ratio of being in a better category, as assessed using a proportional odds model. Multiple imputation techniques were used to impute an outcome for 4 patients for whom the outcome was unknown.||1.97|0.79|.33
72349418|NCT02287467|144219907|SUPERIORITY||Odds Ratio (OR)|0.95||||0.84|TWO_SIDED|95.0|0.61|1.48|||Regression, Logistic|Adjusted for baseline clinical status, region, and participation in the pilot study.|Odds ratio is for hIVIG vs placebo. An odds ratio greater than 1 favors the hIVIG group.|Odds ratio for being in a better category, from a proportional odds model||1.48|0.61|.84
72349419|NCT02287467|144219908|SUPERIORITY||Odds Ratio (OR)|0.87||||0.52|TWO_SIDED|95.0|0.57|1.33|||Regression, Cox|adjusted for baseline clinical status, region, and participation in the pilot study.|Odds ratio is for hIVIG vs. placebo. An odds ratio \> 1 favors the hIVIG group.|Odds ratio for being in a better group, from a proportional odds model.||1.33|0.57|.52
72349420|NCT02287467|144219909|SUPERIORITY||Odds Ratio (OR)|1.49||||0.2|TWO_SIDED|95.0|0.81|2.74|||Regression, Logistic|adjusted for baseline clinical status, region, and participation in the pilot study.|Odds ratio for hIVIG vs placebo. An odds ratio \> 1.0 favors the hIVIG group.|||2.74|0.81|.20
72349421|NCT02287467|144219910|SUPERIORITY||Hazard Ratio (HR)|1.11||||0.44|TWO_SIDED|95.0|0.85|1.45|||Regression, Cox|Stratified by baseline clinical status, region, and participation in the pilot study.|hazard ratio is hIVIG vs placebo; a hazard ratio \>1 favors the hIVIG group.|Deaths during hospitalization are censored after day 7.||1.45|.85|.44
72349422|NCT02287467|144219911|SUPERIORITY||Hazard Ratio (HR)|1.72||||0.4|TWO_SIDED|95.0|0.48|6.15|||Regression, Cox|stratified by baseline clinical status, region, and participation in pilot study|hazard ratio is for hIVIG vs placebo; a hazard ratio \< 1.0 favors the hIVIG group.|||6.15|.48|.40
72349423|NCT02287467|144219912|SUPERIORITY||Odds Ratio (OR)|0.87||||0.74|TWO_SIDED|95.0|0.38|1.98|||Regression, Logistic|adjusted for baseline clinical status, region, and participation in pilot study|odds ratio is for hIVIG vs placebo; an odds ratio \> 1.0 favors hIVIG|||1.98|.38|.74
72349424|NCT02287467|144219913|SUPERIORITY||Mean Difference (Net)|0.14||||0.49|TWO_SIDED|95.0|-0.26|0.54|||Regression, Linear|Adjusted for baseline RNA, geographic region, and influenza subtype|Change is calculated as day 3 - baseline. Difference in changes is hIVIG - placebo.|||.54|-.26|.49
72349425|NCT02287467|144219914|SUPERIORITY||Odds Ratio (OR)|0.97||||0.93|TWO_SIDED|95.0|0.5|1.97|||Regression, Logistic|adjusted for baseline clinical status, region, and participation in pilot study.|Odds ratio is for hIVIG vs placebo.|||1.97|0.5|.93
72349426|NCT02287467|144219915|SUPERIORITY||Odds Ratio (OR)|0.92||||0.81|TWO_SIDED|95.0|0.5|1.82|||Regression, Logistic|adjusted for baseline clinical status, region, and participation in pilot study|odds ratio is for hIVIG group vs placebo|||1.82|0.5|.81
72349427|NCT02287467|144219916|SUPERIORITY||Odds Ratio (OR)|1.17||||0.55|TWO_SIDED|95.0|0.7|1.95|||Regression, Logistic|adjusted for baseline clinical status, region, and participation in the pilot study|Odds ratio (hIVIG vs placebo) of being in a better category. An odds ratio \> 1 favors the hIVIG group.|Proportional odds for being in a better category||1.95|0.70|.55
72349428|NCT02287467|144219917|SUPERIORITY||Odds Ratio (OR)|1.12||||0.77|TWO_SIDED|95.0|0.5|2.31|||Regression, Logistic|adjusted for baseline clinical status, region, and participation in pilot study|odds ratio is for hIVIG vs placebo|||2.31|.5|.77
72349429|NCT02287467|144219918|SUPERIORITY||Odds Ratio (OR)|1.32||||0.34|TWO_SIDED|95.0|0.7|2.34|||Regression, Logistic|adjusted for baseline clinical status, region, and participation in pilot study|odds ratio is expressed as hIVIG vs placebo|||2.34|0.7|.34
72349430|NCT02287467|144219919|SUPERIORITY||Odds Ratio (OR)|0.9||||0.73|TWO_SIDED|95.0|0.5|1.62||adjusted for baseline clinical status, region, and participation in pilot study|Regression, Logistic|adjusted for baseline clinical status, region, and participation in pilot study|odds ratio (hIVIG vs placebo) is for being in a better category. An odds ratio \>1 favors the hIVIG group.|||1.62|.50|.73
72349431|NCT02287467|144219920|SUPERIORITY||Odds Ratio (OR)|0.94||||0.82|TWO_SIDED|95.0|0.55|1.59|||Regression, Logistic|adjusted for baseline clinical status, region, and participation in the pilot study.|Odds ratio (hIVIG vs placebo) is for being in a better category.|Multiple imputation was used to estimate the outcome for 3 participants for whom the outcome was partially unknown.||1.59|0.55|.82
72349432|NCT02287467|144219921|SUPERIORITY||Odds Ratio (OR)|3.19||||0.02|TWO_SIDED|95.0|1.21|8.42|||Regression, Logistic|adjusted for baseline clinical status, region, and participation in pilot study|Odds ratio (hIVIG vs placebo) for a better outcome. An odds ratio \> 1 favors the hIVIG group.|Multiple imputation was used to estimate the outcome for one participant.||8.42|1.21|.02
72349433|NCT02287467|144219922|SUPERIORITY||ratio of geometric means|1.5||||0.18|TWO_SIDED|95.0|0.84|2.7|||Mixed Models Analysis|longitudinal regression with adjustment for baseline titer|Ratio of hIVIG group to placebo group. A ratio \> 1.0 indicates higher titers for the hIVIG group.|HAI measurements were log-transformed to compute treatment differences and the model was adjusted for baseline titer.||2.7|0.84|.18
72349434|NCT02287467|144219923|SUPERIORITY||ratio of geometric means|1.31||||0.13|TWO_SIDED|95.0|0.93|1.8|||Mixed Models Analysis|longitudinal analysis of log-transformed titers adjust for baseline titer.|Ratio of geometric means of hIVIG vs placebo. A ratio \>1.0 indicates higher titers in the hIVIG group on day 7.|||1.8|0.93|.13
72349435|NCT02287467|144219924|SUPERIORITY||ratio of geometric means|0.94||||0.78|TWO_SIDED|95.0|0.58|1.5|||Mixed Models Analysis|log-transformed titers adjusted for baseline titer|ratio of geometric mean for hIVIG vs placebo. A ratio \> 1.0 indicates higher titers at day 7 for the hIVIG group.|||1.5|0.58|.78
72349436|NCT01456169|144219932|SUPERIORITY_OR_OTHER||LS mean difference|-14.7|||<|0.001|TWO_SIDED|95.0|-17.6|-11.8|||ANCOVA|ANCOVA model with treatment as a fixed effect and baseline trough, sitting, clinic SBP as a covariate.||The type I error was controlled using a 2-step hierarchical testing procedure. In the first step, the high dose (40/25 mg) of Azilsartan medoxomil + chlorthalidone was compared to Azilsartan medoxomil alone. If the comparison in step 1 was statistically significant at a significance level of 5%, then step 2 was performed by comparing the low dose (40/12.5 mg) and monotherapy at the 5% significance level.||-11.8|-17.6|<0.001
72349437|NCT01456169|144219932|SUPERIORITY_OR_OTHER||LS mean difference|-9.5|||<|0.001|TWO_SIDED|95.0|-12.4|-6.5|||ANCOVA|ANCOVA model with treatment as a fixed effect and baseline trough, sitting, clinic SBP as a covariate||||-6.5|-12.4|<0.001
72349438|NCT00570310|144219955|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.42||||0.003||90.0|-2.25|-0.6||1-sided, alpha = 0.05|ANOVA||Primary Hypothesis: In 'primary responder population', pregabalin is superior to placebo in maintaining pain control measured by change (3-day average: end of the randomization period versus end of maintenance period) in evening pain intensity.|||-0.60|-2.25|0.003
72349439|NCT00570310|144219956|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.67|||<|0.001||95.0|5.26|10.08||1-sided, alpha = 0.05|ANOVA|||||10.08|5.26|<0.001
72349440|NCT00900666|144219957|NON_INFERIORITY_OR_EQUIVALENCE|a priori power calculation suggested N=26 for each group.||||||0.761|TWO_SIDED|95.0||||p\<0.05 threshold|ANOVA|Correlations with walking speed and time since injury were initially performed to determine whether ANCOVA would be be more appropriate.||ANOVA||||0.761
72349441|NCT00900666|144219958|SUPERIORITY_OR_OTHER|||||||0.896||95.0|||||ANOVA|||||||.896
72349442|NCT00684775|144219978|SUPERIORITY||Odds Ratio (OR)|6.0|||=|0.002|TWO_SIDED|95.0|1.44|25.0|||General Estimating Equation (GEE)|||||25.0|1.44|=0.002
72349443|NCT00684775|144219979|SUPERIORITY|||||||0.0081|||||||t-test, 2 sided|||||||0.0081
72349444|NCT00684775|144219980|SUPERIORITY||Odds Ratio (OR)|1.34||||0.56|TWO_SIDED|95.0|0.5|3.6|||General Estimating Equation (GEE)|||||3.6|.5|0.56
72349445|NCT00684775|144219981|SUPERIORITY||Odds Ratio (OR)|1.45|||=|0.41|TWO_SIDED|95.0|0.6|3.53|||General Estimating Equation (GEE)|||||3.53|.6|=0.41
72349446|NCT00684775|144219982|SUPERIORITY||Odds Ratio (OR)|1.19||||0.75|TWO_SIDED|95.0|0.42|3.36|||General Estimating Equation (GEE)|||||3.36|.42|0.75
72349447|NCT00684775|144219983|SUPERIORITY|||||||0.1543|||||||t-test, 2 sided|||||||0.1543
72349448|NCT00684775|144219984|SUPERIORITY||Odds Ratio (OR)|1.82||||0.15|TWO_SIDED|95.0|0.81|4.1|||General Estimating Equation (GEE)|||||4.1|.81|0.15
72349449|NCT00666406|144219985|SUPERIORITY_OR_OTHER_LEGACY||Ratio of the geometric means|1.173|||||TWO_SIDED|90.0|1.089|1.262||||||||1.262|1.089|
72349450|NCT00666406|144219986|SUPERIORITY_OR_OTHER_LEGACY||Ratio of the geometric means|1.139|||||TWO_SIDED|90.0|1.043|1.243||||||||1.243|1.043|
72349451|NCT00666406|144219987|SUPERIORITY_OR_OTHER_LEGACY||Ratio of the geometric means|1.06|||||TWO_SIDED|90.0|0.866|1.297||||||||1.297|0.866|
72349452|NCT00666406|144219988|SUPERIORITY_OR_OTHER_LEGACY||Ratio of the geometric means|1.071|||||TWO_SIDED|90.0|0.972|1.179||||||||1.179|0.972|
72349453|NCT00666406|144219989|SUPERIORITY_OR_OTHER_LEGACY||Ratio of the geometric means|1.171|||||TWO_SIDED|90.0|1.099|1.247||||||||1.247|1.099|
72349454|NCT00666406|144219990|SUPERIORITY_OR_OTHER_LEGACY||Ratio of the geometric means|1.135|||||TWO_SIDED|90.0|1.092|1.18||||||||1.180|1.092|
72349455|NCT00666406|144219991|SUPERIORITY_OR_OTHER_LEGACY||Ratio of the geometric means|1.036|||||TWO_SIDED|90.0|0.857|1.253||||||||1.253|0.857|
72349456|NCT00666406|144219992|SUPERIORITY_OR_OTHER_LEGACY||Ratio of the geometric means|1.093|||||TWO_SIDED|90.0|1.007|1.186||||||||1.186|1.007|
72349457|NCT00666406|144219993|SUPERIORITY_OR_OTHER_LEGACY||Ratio of the geometric means|0.854|||||TWO_SIDED|90.0|0.798|0.913||||||||0.913|0.798|
72349458|NCT00666406|144219994|SUPERIORITY_OR_OTHER_LEGACY||Ratio of the geometric means|0.881|||||TWO_SIDED|90.0|0.847|0.916||||||||0.916|0.847|
72349459|NCT00666406|144219995|SUPERIORITY_OR_OTHER_LEGACY||Ratio of the geometric means|0.964|||||TWO_SIDED|90.0|0.799|1.164||||||||1.164|0.799|
72349460|NCT00666406|144219996|SUPERIORITY_OR_OTHER_LEGACY||Ratio of the geometric means|0.915|||||TWO_SIDED|90.0|0.841|0.995||||||||0.995|0.841|
72429144|NCT01474512|144369233|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||The LS Mean and p-values were calculated using an ANCOVA model and included treatment, geographic region, previous non-biologic systemic therapy, baseline weight category, and baseline WPAI value.|ANCOVA|P-value is for work productively loss.||||||<0.001
72429145|NCT01474512|144369234|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||LS Mean and p-values were calculated using an ANCOVA model that included treatment, geographic region, previous non-biologic systemic therapy, baseline weight category, and baseline QIDS value in the model.|ANCOVA|||||||<0.001
72429146|NCT01474512|144369234|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||LS Mean and p-values were calculated using an ANCOVA model that included treatment, geographic region, previous non-biologic systemic therapy, baseline weight category, and baseline QIDS value in the model.|ANCOVA|||||||<0.001
72349461|NCT00666406|144219997|SUPERIORITY_OR_OTHER_LEGACY||Ratio of the geometric means|1.177|||||TWO_SIDED|90.0|1.104|1.256||||||||1.256|1.104|
72349462|NCT00666406|144219998|SUPERIORITY_OR_OTHER_LEGACY||Ratio of the geometric means|1.152|||||TWO_SIDED|90.0|1.039|1.277||||||||1.277|1.039|
72349463|NCT00666406|144219999|SUPERIORITY_OR_OTHER_LEGACY||Ratio of the geometric means|1.182|||||TWO_SIDED|90.0|1.029|1.359||||||||1.359|1.029|
72349464|NCT00666406|144220000|SUPERIORITY_OR_OTHER_LEGACY||Ratio of the geometric means|1.133|||||TWO_SIDED|90.0|1.01|1.27||||||||1.270|1.010|
72349465|NCT00666406|144220001|SUPERIORITY_OR_OTHER_LEGACY||Ratio of the geometric means|1.008|||||TWO_SIDED|90.0|0.969|1.05||||||||1.050|0.969|
72349466|NCT00666406|144220002|SUPERIORITY_OR_OTHER_LEGACY||Ratio of the geometric means|0.964|||||TWO_SIDED|90.0|0.843|1.102||||||||1.102|0.843|
72349467|NCT00666406|144220003|SUPERIORITY_OR_OTHER_LEGACY||Ratio of the geometric means|1.038|||||TWO_SIDED|90.0|0.926|1.163||||||||1.163|0.926|
72349468|NCT00666406|144220004|SUPERIORITY_OR_OTHER_LEGACY||Ratio of the geometric means|1.015|||||TWO_SIDED|90.0|0.901|1.144||||||||1.144|0.901|
72349469|NCT00666406|144220005|SUPERIORITY_OR_OTHER_LEGACY||Ratio of the geometric means|1.178|||||TWO_SIDED|90.0|1.106|1.254||||||||1.254|1.106|
72349470|NCT00666406|144220006|SUPERIORITY_OR_OTHER_LEGACY||Ratio of the geometric means|1.152|||||TWO_SIDED|90.0|1.038|1.279||||||||1.279|1.038|
72349471|NCT00666406|144220007|SUPERIORITY_OR_OTHER_LEGACY||Ratio of the geometric means|1.183|||||TWO_SIDED|90.0|1.027|1.362||||||||1.362|1.027|
72349472|NCT00666406|144220008|SUPERIORITY_OR_OTHER_LEGACY||Ratio of the geometric means|1.133|||||TWO_SIDED|90.0|1.012|1.27||||||||1.270|1.012|
72349473|NCT00666406|144220009|SUPERIORITY_OR_OTHER_LEGACY||Ratio of the geometric means|1.009|||||TWO_SIDED|90.0|0.964|1.056||||||||1.056|0.964|
72349474|NCT00666406|144220010|SUPERIORITY_OR_OTHER_LEGACY||Ratio of the geometric means|0.971|||||TWO_SIDED|90.0|0.849|1.112||||||||1.112|0.849|
72349475|NCT00666406|144220011|SUPERIORITY_OR_OTHER_LEGACY||Ratio of the geometric means|1.02|||||TWO_SIDED|90.0|0.938|1.109||||||||1.109|0.938|
72349476|NCT00666406|144220012|SUPERIORITY_OR_OTHER_LEGACY||Ratio of the geometric means|0.996|||||TWO_SIDED|90.0|0.894|1.111||||||||1.111|0.894|
72349477|NCT00666406|144220013|SUPERIORITY_OR_OTHER_LEGACY||Ratio of the geometric means|1.0|||||TWO_SIDED|90.0|1.0|1.0||||||||1.000|1.000|
72349478|NCT00666406|144220014|SUPERIORITY_OR_OTHER_LEGACY||Ratio of the geometric means|1.303|||||TWO_SIDED|90.0|0.841|2.02||||||||2.020|0.841|
72349479|NCT00666406|144220015|SUPERIORITY_OR_OTHER_LEGACY||Ratio of the geometric means|0.724|||||TWO_SIDED|90.0|0.304|1.728||||||||1.728|0.304|
72349480|NCT00666406|144220016|SUPERIORITY_OR_OTHER_LEGACY||Ratio of the geometric means|1.059|||||TWO_SIDED|90.0|0.442|2.539||||||||2.539|0.442|
72349481|NCT00666406|144220017|SUPERIORITY_OR_OTHER_LEGACY||Ratio of the geometric means|0.862|||||TWO_SIDED|90.0|0.807|0.92||||||||0.920|0.807|
72349482|NCT00666406|144220018|SUPERIORITY_OR_OTHER_LEGACY||Ratio of the geometric means|0.855|||||TWO_SIDED|90.0|0.73|1.002||||||||1.002|0.730|
72349483|NCT00666406|144220019|SUPERIORITY_OR_OTHER_LEGACY||Ratio of the geometric means|0.984|||||TWO_SIDED|90.0|0.788|1.228||||||||1.228|0.788|
72349484|NCT00666406|144220020|SUPERIORITY_OR_OTHER_LEGACY||Ratio of the geometric means|0.911|||||TWO_SIDED|90.0|0.8|1.039||||||||1.039|0.800|
72349485|NCT06964165|144220021|OTHER||Difference in pre-IDS ORR|-39.0|||||TWO_SIDED|80.0|-56.8|-17.7|||||||Confidence interval was calculated using the unstratified Miettinen-Nurminen method.|-17.7|-56.8|
72349486|NCT01514201|144220050|OTHER|This was descriptive in nature. Two of the first 5 patients who were escalated to 175 mg/m2 of temozolomide during the maintenance intra-patient dose escalation had dose-modifying toxicities (DMTs). Since the ad hoc stopping rule was met, intra-patient dose escalation was halted and all subsequent patients were to receive 135 mg/m2 of temozolomide during maintenance.|Percentage of patients with DMTs|40.0|||||TWO_SIDED|||||||||Intra-patient dose escalation of temozolomide during maintenance was assessed based on similar rules employed in traditional 3+3 designs. For example intra-patient dose escalation would be halted if at any time 2 out of first 2-6 patients experienced dose-modifying toxicities at a given dose level or if 4 out of first 12 patients experienced dose-modifying toxicities at a given dose level.||||
72349487|NCT02534909|144220092|OTHER|Bayesian analysis of response rate in serum LDH (period 1 completers only)|Median response rate|99.0|||||TWO_SIDED|95.0|81.9|100.0|||||95% Credibility Interval for Response Rate|Up to Week 4||100.0|81.9|
72349488|NCT02534909|144220093|OTHER||Geometric LS mean Ratio to Baseline|0.19|||<|0.001|TWO_SIDED|95.0|0.15|0.23|||Mixed Models Analysis||The longitudinal mixed effects model included timepoint, log baseline as a covariate and the log baseline by timepoint interaction. C5 variant status was included as a categorical covariate.|Period 1 Day 29 serum LDH levels||0.23|0.15|<0.001
72349489|NCT02534909|144220093|OTHER||Geometric LS mean Ratio to Baseline|0.19|||<|0.001|TWO_SIDED|95.0|0.15|0.23|||Mixed Models Analysis||The longitudinal mixed effects model included timepoint, log baseline as a covariate and the log baseline by timepoint interaction. C5 variant status was included as a categorical covariate.|Period 2 Day 365 serum LDH levels||0.23|0.15|<0.001
72349490|NCT02534909|144220093|OTHER||Geometric LS mean Ratio to Baseline|0.17|||<|0.001|TWO_SIDED|95.0|0.14|0.2|||Mixed Models Analysis||The longitudinal mixed effects model included timepoint, log baseline as a covariate and the log baseline by timepoint interaction. C5 variant status was included as a categorical covariate.|Period 3 Day 1429 serum LDH levels||0.20|0.14|<0.001
72349491|NCT02534909|144220093|OTHER||Geometric LS mean Ratio to Baseline|0.19|||<|0.001|TWO_SIDED|95.0|0.15|0.24|||Mixed Models Analysis||The longitudinal mixed effects model included timepoint, log baseline as a covariate and the log baseline by timepoint interaction. C5 variant status was included as a categorical covariate.|Period 4 Day 141 serum LDH levels||0.24|0.15|<0.001
72349492|NCT00362648|144220100|SUPERIORITY_OR_OTHER||Efficacy = 1-Relative Risk|39.3|||<|0.001||95.0|19.1|54.7||Efficacy\>0%. Based on p\< 1/(1+k), where p is proportion of subjects with outcome in vaccine group relative to total number of subjects with outcome, and k is ratio of follow-up time; placebo / vaccine. Based on conditional binomial approach.|Exact binomial test||Efficacy = 1-RR, expressed as a percentage; the RR is the incidence in the vaccine group / the incidence in the placebo group.|The number randomized is different from the number analyzed because some data were excluded from the analysis: subjects were classified as unevaluable due to wildtype rotavirus in stool before 14 days Postdose 3, incomplete clinical and/or laboratory results, or stool samples collected out of day range. Rotavirus gastroenteritis cases are subjects with one or more positive episodes. The most severe positive episode is used for the date of the case.||54.7|19.1|<0.001
72349493|NCT00362648|144220100|SUPERIORITY_OR_OTHER||Efficacy = 1-Relative Risk|48.3|||<|0.001||95.0|22.3|66.1||Efficacy\>0%. Based on p\< 1/(1+k), where p is proportion of subjects with outcome in vaccine group relative to total number of subjects with outcome, and k is ratio of follow-up time; placebo / vaccine. Based on conditional binomial approach.|Exact binomial test||Efficacy = 1-RR, expressed as a percentage; the RR is the incidence in the vaccine group / the incidence in the placebo group.|The number randomized is different from the number analyzed because some data were excluded from the analysis: subjects were classified as unevaluable due to wildtype rotavirus in stool before 14 days Postdose 3, incomplete clinical and/or laboratory results, or stool samples collected out of day range. Rotavirus gastroenteritis cases are subjects with one or more positive episodes. The most severe positive episode is used for the date of the case.||66.1|22.3|<0.001
72349494|NCT00362648|144220101|SUPERIORITY_OR_OTHER||Percentage|78.3||||||95.0|71.7|84.0||||||Anti-rotavirus IgA||84.0|71.7|
72349495|NCT00362648|144220101|SUPERIORITY_OR_OTHER||Percentage|18.5||||||95.0|13.3|24.8||||||Serotype G1||24.8|13.3|
72349496|NCT00362648|144220101|SUPERIORITY_OR_OTHER||Percentage|9.0||||||95.0|5.3|14.0||||||Serotype G2||14.0|5.3|
72349497|NCT00362648|144220101|SUPERIORITY_OR_OTHER||Percentage|6.3||||||95.0|3.3|10.8||||||Serotype G3||10.8|3.3|
72349498|NCT00362648|144220101|SUPERIORITY_OR_OTHER||Percentage|26.5||||||95.0|20.3|33.3||||||Serotype G4||33.3|20.3|
72349499|NCT00362648|144220101|SUPERIORITY_OR_OTHER||Percentage|14.4||||||95.0|9.7|20.2||||||Serotype P1A\[8\]||20.2|9.7|
72349500|NCT00362648|144220101|SUPERIORITY_OR_OTHER||Percentage|20.1||||||95.0|14.4|27.0||||||Anti-rotavirus IgA||27.0|14.4|
72349501|NCT00362648|144220101|SUPERIORITY_OR_OTHER||Percentage|0.0||||||95.0|0.0|2.2||||||Serotype G1||2.2|0.0|
72349502|NCT00362648|144220101|SUPERIORITY_OR_OTHER||Percentage|3.0||||||95.0|1.0|6.8||||||Serotype G2||6.8|1.0|
72349503|NCT00362648|144220101|SUPERIORITY_OR_OTHER||Percentage|2.4||||||95.0|0.6|5.9||||||Serotype G3||5.9|0.6|
72349504|NCT00362648|144220101|SUPERIORITY_OR_OTHER||Percentage|2.4||||||95.0|0.6|5.9||||||Serotype G4||5.9|0.6|
72429147|NCT01474512|144369235|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||The LS Mean and p-values were calculated using an ANCOVA model and included treatment, geographic region, previous non-biologic systemic therapy, baseline weight category, and baseline SF-36 value in the model.|ANCOVA|P-value is for PCS.||||||<0.001
72349505|NCT00362648|144220101|SUPERIORITY_OR_OTHER||Percentage|4.7||||||95.0|2.1|9.1||||||Serotype P1A\[8\]||9.1|2.1|
72349506|NCT00362648|144220102|SUPERIORITY_OR_OTHER||Percentage|87.8||||||95.0|80.9|92.9||||||Anti-rotavirus IgA||92.9|80.9|
72349507|NCT00362648|144220102|SUPERIORITY_OR_OTHER||Percentage|32.1||||||95.0|24.2|40.8||||||Serotype G1||40.8|24.2|
72349508|NCT00362648|144220102|SUPERIORITY_OR_OTHER||Percentage|9.9||||||95.0|5.4|16.4||||||Serotype G2||16.4|5.4|
72349509|NCT00362648|144220102|SUPERIORITY_OR_OTHER||Percentage|28.2||||||95.0|20.7|36.8||||||Serotype G3||36.8|20.7|
72349510|NCT00362648|144220102|SUPERIORITY_OR_OTHER||Percentage|18.3||||||95.0|12.1|26.0||||||Serotype G4||26.0|12.1|
72349511|NCT00362648|144220102|SUPERIORITY_OR_OTHER||Percentage|27.5||||||95.0|20.0|36.0||||||Serotype P1A\[8\]||36.0|20.0|
72349512|NCT00362648|144220102|SUPERIORITY_OR_OTHER||Percentage|18.2||||||95.0|12.0|25.8||||||Anti-rotavirus IgA||25.8|12.0|
72349513|NCT00362648|144220102|SUPERIORITY_OR_OTHER||Percentage|2.3||||||95.0|0.5|6.5||||||Serotype G1||6.5|0.5|
72349514|NCT00362648|144220102|SUPERIORITY_OR_OTHER||Percentage|0.8||||||95.0|0.0|4.1||||||Serotype G2||4.1|0.0|
72349515|NCT00362648|144220102|SUPERIORITY_OR_OTHER||Percentage|3.0||||||95.0|0.8|7.6||||||Serotype G3||7.6|0.8|
72349516|NCT00362648|144220102|SUPERIORITY_OR_OTHER||Percentage|0.0||||||95.0|0.0|2.8||||||Serotype G4||2.8|0.0|
72349517|NCT00362648|144220102|SUPERIORITY_OR_OTHER||Percentage|5.3||||||95.0|2.2|10.6||||||Serotype P1A\[8\]||10.6|2.2|
72349518|NCT04522141|144220159|OTHER|||||||0.038||||||Controlled for age, sex, education, race, self-reported functional health, and self-reported health status.|Mixed Models Analysis|||Main effect||||0.038
72349519|NCT04522141|144220159|SUPERIORITY|||||||0.941||||||Controlled for age, sex, education, race, self-reported functional health, and self-reported health status.|Mixed Models Analysis|||Time by condition interaction||||0.941
72349520|NCT04522141|144220160|OTHER|||||||0.003||||||Controlled for age, sex, education, race, self-reported functional health, and self-reported health status.|Mixed Models Analysis|||Main effect||||0.003
72349521|NCT04522141|144220160|SUPERIORITY|||||||0.027||||||Controlled for age, sex, education, race, self-reported functional health, and self-reported health status.|Mixed Models Analysis|||Time by condition interaction||||0.027
72349522|NCT04522141|144220161|OTHER||||||<|0.001||||||Controlled for age, sex, education, race, self-reported functional health, and self-reported health status.|Mixed Models Analysis|||Main effect||||< .001
72349523|NCT04522141|144220161|SUPERIORITY|||||||0.411||||||Controlled for age, sex, education, race, self-reported functional health, and self-reported health status.|Mixed Models Analysis|||Time by condition interaction||||0.411
72349524|NCT04522141|144220162|OTHER||||||<|0.001||||||Controlled for age, sex, education, race, self-reported functional health, and self-reported health status|Mixed Models Analysis|||Main effect weekly self-control||||< .001
72349525|NCT04522141|144220162|SUPERIORITY|||||||0.176||||||Controlled for age, sex, education, race, self-reported functional health, and self-reported health status|Mixed Models Analysis|||Time by condition interaction weekly self-control||||0.176
72349526|NCT04522141|144220163|OTHER||||||>|0.05||||||Analyses are controlled for age, sex, education, race, self-reported functional health, and self-reported health status.|Mixed Models Analysis|||Main effect||||> .05
72349527|NCT04522141|144220163|SUPERIORITY||||||>|0.05||||||Analyses are controlled for age, sex, education, race, self-reported functional health, and self-reported health status.|Mixed Models Analysis|||Time by condition interaction||||> .05
72349528|NCT04522141|144220164|OTHER|||||||0.031||||||Controlled for age, sex, education, race, self-reported functional health, and self-reported health status.|Mixed Models Analysis|||Main effect||||0.031
72349529|NCT04522141|144220164|SUPERIORITY|||||||0.26|||||||Mixed Models Analysis|Controlled for age, sex, education, race, self-reported functional health, and self-reported health status.||Time by condition interaction||||0.260
72349530|NCT04522141|144220165|OTHER|||||||0.016||||||Controlled for age, sex, education, race, self-reported functional health, and self-reported health status.|Mixed Models Analysis|||Main effect||||0.016
72349531|NCT04522141|144220165|SUPERIORITY|||||||0.363||||||Controlled for age, sex, education, race, self-reported functional health, and self-reported health status.|Mixed Models Analysis|||Time by condition interaction||||0.363
72349532|NCT04522141|144220166|OTHER||||||>|0.05||||||Analyses are controlled for age, sex, education, race, self-reported functional health, and self-reported health status.|Mixed Models Analysis|||Main effect||||> .05
72349533|NCT04522141|144220166|SUPERIORITY||||||>|0.05||||||Analyses are controlled for age, sex, education, race, self-reported functional health, and self-reported health status.|Mixed Models Analysis|||Time by condition interaction||||> .05
72349534|NCT04522141|144220167|OTHER|||||||0.389||||||Controlled for age, sex, education, race, self-reported functional health, and self-reported health status.|Mixed Models Analysis|||Main effect||||0.389
72349535|NCT04522141|144220167|SUPERIORITY|||||||0.516||||||Controlled for age, sex, education, race, self-reported functional health, and self-reported health status.|Mixed Models Analysis|||Time by condition interaction||||0.516
72349536|NCT04522141|144220168|OTHER|||||||0.005||||||Controlled for age, sex, education, race, self-reported functional health, and self-reported health status.|Mixed Models Analysis|||Main effect||||0.005
72349537|NCT04522141|144220168|SUPERIORITY|||||||0.555||||||Controlled for age, sex, education, race, self-reported functional health, and self-reported health status.|Mixed Models Analysis|||Time by condition interaction||||0.555
72349538|NCT04522141|144220169|OTHER|||||||0.206||||||Controlled for age, sex, education, race, self-reported functional health, and self-reported health status.|Mixed Models Analysis|||Main effect||||0.206
72349539|NCT04522141|144220169|SUPERIORITY|||||||0.026||||||Controlled for age, sex, education, race, self-reported functional health, and self-reported health status.|Mixed Models Analysis|||Time by condition interaction||||0.026
72349540|NCT00555217|144220177|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.88||||0.3|TWO_SIDED|95.0|0.7|1.12|||Log Rank||Combination ARB and ACEI vs. mono therapy ARB|||1.12|0.70|0.30
72349541|NCT00555217|144220178|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.78||||0.1|TWO_SIDED|95.0|0.58|1.05|||Log Rank||Combination ARB and ACEI vs. mono therapy ARB|||1.05|0.58|0.10
72349542|NCT00367835|144220180|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||ANCOVA|||||||<0.001
72349543|NCT00367835|144220181|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||ANCOVA|||||||<0.001
72349544|NCT00367835|144220182|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel|||||||<0.001
72349545|NCT00367835|144220183|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel|||||||<0.001
72349546|NCT00367835|144220184|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||ANCOVA|||||||<0.001
72349547|NCT00367835|144220185|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002||95.0|||||ANCOVA|||||||0.002
72349548|NCT00367835|144220186|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||ANOVA|||||||<0.001
72349549|NCT01025830|144220193|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was defined as a 90% Confidence Interval of the geometric mean ratio between 0.8 and 1.25. Differences between treatments with respect to the outcome and intra- and inter-subject variances were assessed using the mixed effects model. Bootstrapped random errors were used.|Geometric Mean Ratio|1.1||||||90.0|0.87|1.38||p value not required for this analysis. What counts is the 90% confidence interval of the geometric mean ratio between the two formulation parameters.|Non-compartmental model|Mixed random effects model was used to assess difference between treatments and intra- and inter-subject variances.|the generic is the numerator while the brand is the denominator|The null hypothesis was that there is a difference in the relative bioavailability of Triomune and brand-name stavudine/lamivudine/nevirapine in HIV-infected Africans. 18 participants were required to provide 80% power to detect approximately a 20% difference on a log scale in AUC0-12h between the brand formulation and the generic formulation. Alpha level of 0.05.||1.38|0.87|
72368384|NCT00298558|144246921|SUPERIORITY_OR_OTHER||Effect Size|0.66|||<|0.01|TWO_SIDED|99.0|0.43|0.88|||Mixed Models Analysis|The blom transformation was used to reduce skewness in the measures. The design factors and baseline covariates were controlled in the model.|Blom transformed outcome was used and the design factors and baseline covariates were controlled in the model to get the adjusted means. After that, the effect size (defined in the Additional details) was calculated using the adjusted means and SD.|Effect size was defined as training improvement from baseline to year 10 minus control improvement from baseline to year 10 divided by the intrasubject standard deviation (SD) of the composite score. Positive effect sizes indicate improvement.||0.88|0.43|<0.01
72349550|NCT01025830|144220193|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was defined as a 90% Confidence Interval of the geometric mean ratio between 0.8 and 1.25. Differences between treatments with respect to the outcome and intra- and inter-subject variances were assessed using the mixed effects model. Bootstrapped random errors were used.|Geometric Mean Ratio|1.1||||||90.0|0.95|1.31||p value not required for this analysis. What counts is the 90% confidence interval of the geometric mean ratio between the two formulation parameters.|Non-compartmental model|Mixed random effects model was used to assess difference between treatments and intra- and inter-subject variances.|the generic is the numerator while the brand is the denominator|The null hypothesis was that there is a difference in the relative bioavailability of Triomune and brand-name stavudine/lamivudine/nevirapine in HIV-infected Africans. 18 participants were required to provide 80% power to detect approximately a 20% difference on a log scale in AUC0-12h between the brand formulation and the generic formulation. Alpha level of 0.05.||1.31|0.95|
72349551|NCT01025830|144220193|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was defined as a 90% Confidence Interval of the geometric mean ratio between 0.8 and 1.25. Differences between treatments with respect to the outcome and intra- and inter-subject variances were assessed using the mixed effects model. Bootstrapped random errors were used.|Geometric Mean Ratio|0.8||||||90.0|0.65|0.99||p value not required for this analysis. What counts is the 90% confidence interval of the geometric mean ratio between the two formulation parameters.|Non-compartmental model|Mixed random effects model was used to assess difference between treatments and intra- and inter-subject variances.|the generic is the numerator while the brand is the denominator|The null hypothesis was that there is a difference in the relative bioavailability of Triomune and brand-name stavudine/lamivudine/nevirapine in HIV-infected Africans. 18 participants were required to provide 80% power to detect approximately a 20% difference on a log scale in AUC0-12h between the brand formulation and the generic formulation. Alpha level of 0.05.||0.99|0.65|
72349552|NCT01025830|144220194|NON_INFERIORITY_OR_EQUIVALENCE|same as for AUC|Geometric Mean Ratio|1.3||||||90.0|0.99|1.71||same as for AUC|Non-compartmental model|same as for AUC|same as AUC|Same as for AUC||1.71|0.99|
72349553|NCT01025830|144220194|NON_INFERIORITY_OR_EQUIVALENCE|same for all three drugs.|Geometric Mean Ratio|1.1||||||90.0|0.95|1.23||Same for all three drugs.|Non-compartmental model|Same for all three drugs.|Same for all three drugs.|Same for all three drugs.||1.23|0.95|
72349554|NCT01025830|144220194|NON_INFERIORITY_OR_EQUIVALENCE|Same for all three drugs.|Geometric Mean Ratio|0.8||||||90.0|0.63|0.98||Same for all three drugs.|Non-compartmental model|Same for all three drugs.|Same for all three drugs.|Same for all three drugs.||0.98|0.63|
72349555|NCT00264537|144220247|SUPERIORITY_OR_OTHER|||||||0.053||||||A positive test is concluded if there is a significant difference between golimumab+MTX and placebo+MTX and at least one of the pair-wise comparisons at a 0.05 level.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test stratified by screening CRP (\< 1.5 mg/dL; \>= 1.5 mg/dL)||Null hypothesis: No difference in ACR 50 response comparing Group 1 vs combined Groups 3 and 4. The sample size of 150 patients per treatment group will provide \>98% power to detect a difference in ACR 50 response between treatment groups at alpha=0.05, assuming 50% of patients with screening C-reactive protein (CRP)\<1.5mg/dL, and the difference in ACR 50 response of 15-20% in patients with screening CRP\<1.5mg/dL and 20-25% in subjects with screening CRP\>=1.5mg/dL, between Groups 1 vs 3 or 4||||0.053
72349556|NCT00264537|144220247|SUPERIORITY_OR_OTHER|||||||0.042|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test stratified by screening C-reactive protein (CRP) (\< 1.5 mg/dL; \>= 1.5 mg/dL)||Null hypothesis: No difference in ACR 50 response comparing Groups 1 vs 3.||||0.042
72349557|NCT00264537|144220247|SUPERIORITY_OR_OTHER|||||||0.177|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test stratified by screening C-reactive protein (CRP) (\< 1.5 mg/dL; \>= 1.5 mg/dL)||Null hypothesis: No difference in ACR 50 response comparing Groups 1 vs 4.||||0.177
72349558|NCT00264537|144220247|NON_INFERIORITY_OR_EQUIVALENCE|This sample size (150 patients per treatment group) will provide approximately 85% power to claim non-inferiority of golimumab alone (Group 2) compared with MTX alone (Group 1) at alpha= 0.05 using a one-sided equivalence test assuming the proportion of golimumab alone (Group 2) treated patients with ACR 50 response is not less than 10% compared with proportion of patients with ACR 50 response in MTX alone (Group 1) treated group.|Difference in ACR 50 Response Rate(%)|3.3||||0.521||95.0|-6.8||The upper bound of 95% CI was not produced because it was not relevant to the pre-specified analysis||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test stratified by screening C-reactive protein (CRP) (\< 1.5 mg/dL; \>= 1.5 mg/dL)|The positive difference indicates in favor of golimumab+placebo compared to placebo+MTX; The upper bound of CI is not applicable.|"Null hypothesis: Group 2 is inferior to Group 1. Noninferiority of golimumab will be demonstrated if the lower bound of the 2-sided 95% CI is above -10%. The 10% non-inferiority margin was chosen because this difference is not clinically admissible. Under the above noted assumed response rates, this corresponds to preservation of at least 70% \[(33% - 10%)/33%\*100\] of the expected MTX benefit."|||-6.8|0.521
72349559|NCT00264537|144220248|SUPERIORITY_OR_OTHER|||||||0.011||95.0|||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel(CMH) test stratified by screening C-reactive protein (CRP) (\< 1.5 mg/dL; \>= 1.5 mg/dL)||||||0.011
72349560|NCT00264537|144220248|SUPERIORITY_OR_OTHER|||||||0.028||95.0|||||Cochran-Mantel-Haenszel|CMH test stratified by screening CRP (\< 1.5 mg/dL; \>= 1.5 mg/dL)||||||0.028
72349561|NCT00264537|144220248|SUPERIORITY_OR_OTHER|||||||0.028||95.0|||||Cochran-Mantel-Haenszel|CMH test stratified by screening CRP (\< 1.5 mg/dL; \>= 1.5 mg/dL)||||||0.028
72349562|NCT00264537|144220248|SUPERIORITY_OR_OTHER|||||||0.677||95.0|||||Cochran-Mantel-Haenszel|CMH test stratified by screening CRP (\< 1.5 mg/dL; \>= 1.5 mg/dL)||||||0.677
72349563|NCT00264537|144220249|SUPERIORITY_OR_OTHER|||||||0.178||95.0|||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test stratified by screening C-reactive protein (CRP) (\< 1.5 mg/dL; \>= 1.5 mg/dL)||||||0.178
72349564|NCT00264537|144220249|SUPERIORITY_OR_OTHER|||||||0.25||95.0|||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test stratified by screening C-reactive protein (CRP) (\< 1.5 mg/dL; \>= 1.5 mg/dL)||||||0.250
72429148|NCT01474512|144369235|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||The LS Mean and p-values were calculated using an ANCOVA model and included treatment, geographic region, previous non-biologic systemic therapy, baseline weight category, and baseline SF-36 value in the model.|ANCOVA|P-value is for PCS.||||||<0.001
72429149|NCT01474512|144369235|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||The LS Mean and p-values were calculated using an ANCOVA model and included treatment, geographic region, previous non-biologic systemic therapy, baseline weight category, and baseline SF-36 value in the model.|ANCOVA|P-value is for MCS.||||||<0.001
72349565|NCT00264537|144220249|SUPERIORITY_OR_OTHER|||||||0.24||95.0|||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel(CMH) test stratified by screening C-reactive protein (CRP) (\< 1.5 mg/dL; \>= 1.5 mg/dL)||||||0.240
72349566|NCT00264537|144220249|SUPERIORITY_OR_OTHER|||||||0.339||95.0|||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel(CMH) test stratified by screening C-reactive protein (CRP) (\< 1.5 mg/dL; \>= 1.5 mg/dL)||||||0.339
72349567|NCT00264537|144220250|SUPERIORITY_OR_OTHER|||||||0.006||||||If this test is significant, a pairwise comparison between Group 3 and Group 1, and between Group 4 and Group 1 will be performed|ANOVA|A 2-sided ANOVA on the van der Waerden normal scores with 1 factor: screening CRP (\< 1.5 mg/dL; ≥ 1.5 mg/dL)||Null Hypothesis: No difference in vdH-S score comparing Groups 1 vs Groups 3 and 4 combined. The sample size of 150 subjects in each treatment group (Group 1, Group 3, Group 4) will provide \> 95% power to detect a difference in the vdH-S score between treatment groups using a 2-sided t-test on van der Waerden normal scores of change from baseline in vdH-S score at α = 0.05, assuming a mean change from baseline in vdH-S score of 3.5 for the placebo group and 1 for Groups 3 and 4.||||0.006
72349568|NCT00264537|144220250|SUPERIORITY_OR_OTHER|||||||0.015|||||||ANOVA|A 2-sided ANOVA on the van der Waerden normal scores with 1 factor: screening CRP (\< 1.5 mg/dL; \>= 1.5 mg/dL)||Null hypothesis: No difference in vdH-S score comparing Groups 1 vs 3.||||0.015
72349569|NCT00264537|144220250|SUPERIORITY_OR_OTHER|||||||0.025|||||||ANOVA|A 2-sided ANOVA on the van der Waerden normal scores with 1 factor: screening CRP (\< 1.5 mg/dL; \>= 1.5 mg/dL)||Null hypothesis: No difference in vdH-S score comparing Groups 1 vs 4.||||0.025
72349570|NCT00264537|144220251|SUPERIORITY_OR_OTHER|||||||0.003|||||||ANOVA|2-sided ANOVA on the van der Waerden normal scores||||||0.003
72349571|NCT00264537|144220251|SUPERIORITY_OR_OTHER|||||||0.01|||||||ANOVA|2-sided ANOVA on the van der Waerden normal scores||||||0.010
72349572|NCT00264537|144220251|SUPERIORITY_OR_OTHER|||||||0.014|||||||ANOVA|2-sided ANOVA on the van der Waerden normal scores||||||0.014
72349573|NCT00264537|144220251|SUPERIORITY_OR_OTHER|||||||0.545|||||||ANOVA|2-sided ANOVA on the van der Waerden normal scores||||||0.545
72349574|NCT03228212|144220254|NON_INFERIORITY|A non-inferiority margin of -5 points was used. This margin is based on a 10% shift in the distribution of CLUE scores.|Mean Difference (Final Values)|5.1|STANDARD_DEVIATION|2.0|||TWO_SIDED|95.0|1.16|9.09|||Bayesian multivariate normal random-effe|A 95% Credible Interval for the Posterior mean difference between the Test and Control was used to test for non-inferiority.|Mean difference was calculated as Test - Control|It was calculated that 60 participants randomized in a 1:1 fashion between the two sequences would have at least 80% power to detect a 5 points difference in mean overall comfort at the 2-week follow-up. Sample size was determined using Stroup's Method (alpha=0.05).||9.09|1.16|
72349575|NCT03228212|144220255|NON_INFERIORITY|A non-inferiority margin of 0.05 logmar was used. This margin corresponds to a half line difference.|Mean Difference (Final Values)|0.02|STANDARD_DEVIATION|0.00621|||TWO_SIDED|95.0|0.01|0.03|||Bayesian multivariate normal random-effe|A 95% Credible Interval for the Posterior mean difference between the Test and Control was used to test for non-inferiority.|Mean difference was calculated as Test - Control|It was calculated that 40 participants randomized in a 1:1 fashion between the two sequences would have at least 80% power to detect a 0.05 difference in LogMAR visual acuity at the 2-week follow-up. Sample size was determined using simulations methods for repeated measures.||0.03|0.01|
72349576|NCT03228212|144220256|NON_INFERIORITY|A non-inferiority margin of 90% was used. Lower limit of 95% credible interval was compared to 90%|proportion|0.992|||||TWO_SIDED|95.0|0.96|1.0|||Bayesian Methods|Bayesian Methods-Jefferys prior for binomial proportion was used to calculate 95% credible interval.||It was calculated that 70 participants randomized in a 1:1 fashion between the two sequences would have at least 80% power to detect a the 2-week follow-up. Sample size was determined using simulations methods for repeated measures. Analysis was only performed on eyes wearing the Tesl lens.||1|0.96|
72349577|NCT03228212|144220257|NON_INFERIORITY|A non-inferiority margin of 5% was used. Upper limit of the 95% credible interval was compared to 5%|Mean Difference (Final Values)|-0.0043|STANDARD_DEVIATION|0.0089|||TWO_SIDED|95.0|-0.0237|0.0129|||Bayesian beta-binomial model|Bayesian beta-binomial model for correlated binary data|Mean difference calculated as Test - Control|It was calculated that 120 participants randomized in a 1:1 fashion between the two sequences would have at least 80% power to detect 5% difference between the Test and Control lens with respect to the proportion of eyes with Grade 3 or higher slit lamp findings across all study visits. Sample size was determined using simulations methods. Sample size for this study was primarily driven by the slit lamp findings.||0.0129|-0.0237|
72349578|NCT03228212|144220258|NON_INFERIORITY|A non-inferiority margin of -5 points was used. This margin is based on a 10% shift in the distribution of CLUE scores.|Mean Difference (Final Values)|7.2|STANDARD_DEVIATION|1.8|||TWO_SIDED|95.0|3.69|10.74|||Bayesian multivariate normal random-effe|A 95% Credible Interval for the Posterior mean difference between the Test and Control was used to test for non-inferiority.|Mean difference was calculated as Test - Control|Sample size calculations were based on the primary endpoints.||10.74|3.69|
72349579|NCT03228212|144220259|NON_INFERIORITY|A non-inferiority margin of -5 points was used. This margin is based on a 10% shift in the distribution of CLUE scores.|Mean Difference (Final Values)|3.3|STANDARD_DEVIATION|1.5|||TWO_SIDED|95.0|0.36|6.29|||Bayesian multivariate normal random-effe|A 95% Credible Interval for the Posterior mean difference between the Test and Control was used to test for non-inferiority.|Mean difference was calculated as Test - Control|Sample size calculations were based on the primary endpoints.||6.29|0.36|
72349580|NCT01807299|144220260|OTHER||Mean Difference (Final Values)|5.0||||0.05|ONE_SIDED|5.0|||||Chi-squared, Corrected|||||||0.05
72349581|NCT01938040|144220268|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED||||||ANOVA|||||||0.001
72349582|NCT00806988|144220298|OTHER|An intention-to-treat analysis using a two-tailed Wilcoxon rank-sum test, at a 0.05 alpha level was used. This analysis accommodated missing LVESVI outcomes owing to death by assigning deceased patients the worst ranks in order according to the time of death. In the case of data that were missing for reasons other than death, we used multiple imputation to calculate the 12-month LVESVI on the assumption that the data were missing at random.||||||0.61|||||||Wilcoxon (Mann-Whitney)|||The primary null hypothesis was that there would be no significant between-group difference in the LVESVI at 12 months.||||0.61
72349583|NCT00806988|144220299|OTHER|||||||0.83|||||||Chi-squared|||||||0.83
72429150|NCT01474512|144369235|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||The LS Mean and p-values were calculated using an ANCOVA model and included treatment, geographic region, previous non-biologic systemic therapy, baseline weight category, and baseline SF-36 value in the model.|ANCOVA|P-value is for MCS.||||||<0.001
72349584|NCT04775953|144220300|SUPERIORITY|For participants with the same DOOR, quality-of-life (QoL) was used as a tiebreaker and was calculated as change from baseline QoL to Day 70 QoL score, as assessed by questions from the PROMIS physical function item bank (PROMIS Item Bank v2.0, short form 6b) on the Antibacterial Resistance Leadership Group (ARLG) Bloodstream Infection QoL Measure. Superiority of dalbavancin is concluded if the lower bound of the 95% confidence interval for the DOOR probability is greater than 50%.|Pr(Better DOOR in dalbavancin arm)|47.7|||||TWO_SIDED|95.0|39.84|55.68|||||The DOOR probability is calculated using the Wilcoxon-Mann-Whitney statistic corrected for ties.|Null Hypothesis: Probability that a participant in the dalbavancin arm has a better DOOR than a participant in the standard of care arm plus one-half the probability of equal DOOR is 50% (i.e., no difference in DOOR).||55.68|39.84|
72349585|NCT04775953|144220301|NON_INFERIORITY|The non-inferiority margin is -20%. Non-inferiority of dalbavancin is concluded if the lower limit of the 95% confidence interval for the difference in proportions of clinical efficacy is greater than -20%.|Risk Difference (RD)|1.0|||||TWO_SIDED|95.0|-12.0|14.0|||||Difference in proportions of clinical efficacy for dalbavancin compared to standard of care and 95% confidence interval obtained from a linear regression model.|Null Hypothesis: The proportion of clinical efficacy in the dalbavancin arm minus the proportion of clinical efficacy in the standard of care arm is -20%.||14|-12|
72349586|NCT02813889|144220321|SUPERIORITY|Two-Factor ANOVA in repeated measures|Mean Difference (Net)|-0.0146||||0.0054|TWO_SIDED|95.0|-0.0261|-0.0031||The threshold for statistical significance was p = 0.05.|ANOVA|p Values were adjusted for multiple comparisons using Tukey-Kramer tests.|Difference = Path Length (Full-Term) - Path Length (Pre-Term)|||-0.0031|-0.0261|0.0054
72349587|NCT02813889|144220322|SUPERIORITY|Two-Factor ANOVA in repeated measures|Mean Difference (Net)|-0.02||||0.0005|TWO_SIDED|95.0|-0.0331|-0.007||The threshold for statistical significance was p = 0.05.|ANOVA|p Values were adjusted for multiple comparisons using Tukey-Kramer tests.|Difference = Path Length (Full-Term) - Path Length (Pre-Term)|||-0.0070|-0.0331|0.0005
72349588|NCT02813889|144220323|SUPERIORITY|Two-Factor ANOVA in repeated measures|Mean Difference (Net)|-0.0146||||0.0088|TWO_SIDED|95.0|-0.0267|-0.0026||The threshold for statistical significance was p = 0.05.|ANOVA|p Values were adjusted for multiple comparisons using Tukey-Kramer tests.|Difference = Path Length (Full-Term) - Path Length (Pre-Term)|||-0.0026|-0.0267|0.0088
72349589|NCT02813889|144220324|SUPERIORITY|Two-Factor ANOVA in repeated measures|Mean Difference (Net)|-0.0059||||0.7624|TWO_SIDED|95.0|-0.018|0.0062||The threshold for statistical significance was p = 0.05.|ANOVA|p Values were adjusted for multiple comparisons using Tukey-Kramer tests.|Difference = Path Length (Full-Term) - Path Length (Pre-Term)|||0.0062|-0.0180|0.7624
72349590|NCT02813889|144220325|SUPERIORITY|Two-Factor ANOVA in repeated measures|Mean Difference (Net)|0.0129||||0.0326|TWO_SIDED|95.0|0.0007|0.0251||The threshold for statistical significance was p = 0.05.|ANOVA|p Values were adjusted for multiple comparisons using Tukey-Kramer tests.|Difference = Path Length per second (Typical) - Path Length per second (Atypical)|||0.0251|0.0007|0.0326
72349591|NCT02813889|144220326|SUPERIORITY|Two-Factor ANOVA in repeated measures|Mean Difference (Net)|0.0309|||<|0.0001|TWO_SIDED|95.0|0.0138|0.048||The threshold for statistical significance was p = 0.05.|ANOVA|p Values were adjusted for multiple comparisons using Tukey-Kramer tests.|Difference = Path Length per second (Typical) - Path Length per second (Atypical)|||0.0480|0.0138|<0.0001
72349592|NCT02813889|144220327|SUPERIORITY|Two-Factor ANOVA in repeated measures|Mean Difference (Net)|0.017||||0.0025|TWO_SIDED|95.0|0.0045|0.0295||The threshold for statistical significance was p = 0.05.|ANOVA|p Values were adjusted for multiple comparisons using Tukey-Kramer tests.|Difference = Path Length per second (Typical) - Path Length per second (Atypical)|||0.0295|0.0045|0.0025
72349593|NCT02813889|144220328|SUPERIORITY|Two-Factor ANOVA in repeated measures|Mean Difference (Net)|0.0066||||0.6782|TWO_SIDED|95.0|-0.0059|0.0191||The threshold for statistical significance was p = 0.05.|ANOVA|p Values were adjusted for multiple comparisons using Tukey-Kramer tests.|Difference = Path Length per second (Typical) - Path Length per second (Atypical)|||0.0191|-0.0059|0.6782
72349594|NCT02813889|144220329|SUPERIORITY|Two-Factor ANOVA in repeated measures|Mean Difference (Net)|1.064||||0.0479|TWO_SIDED|95.0|0.006|2.122||The threshold for statistical significance was p = 0.05.|ANOVA|p Values were adjusted for multiple comparisons using Tukey-Kramer tests.|Difference = StdDevY (Full-Term) - StdDevY (Pre-Term)|||2.122|0.006|0.0479
72349595|NCT02813889|144220330|SUPERIORITY|Two-Factor ANOVA in repeated measures|Mean Difference (Net)|0.278||||0.9947|TWO_SIDED|95.0|-0.921|1.477||The threshold for statistical significance was p = 0.05.|ANOVA|p Values were adjusted for multiple comparisons using Tukey-Kramer tests.|Difference = StdDevY (Full-Term) - StdDevY (Pre-Term)|||1.477|-0.921|0.9947
72349596|NCT02813889|144220331|SUPERIORITY|Two-Factor ANOVA in repeated measures|Mean Difference (Net)|0.835||||0.2614|TWO_SIDED|95.0|-0.274|1.945||The threshold for statistical significance was p = 0.05.|ANOVA|p Values were adjusted for multiple comparisons using Tukey-Kramer tests.|Difference = StdDevY (Full-Term) - StdDevY (Pre-Term)|||1.945|-0.274|0.2614
72349597|NCT02813889|144220332|SUPERIORITY|Two-Factor ANOVA in repeated measures|Mean Difference (Net)|1.176||||0.0314|TWO_SIDED|95.0|0.066|2.286||The threshold for statistical significance was p = 0.05.|ANOVA|p Values were adjusted for multiple comparisons using Tukey-Kramer tests.|Difference = StdDevY (Full-Term) - StdDevY (Pre-Term)|||2.286|0.066|0.0314
72349598|NCT02813889|144220333|SUPERIORITY|Two-Factor ANOVA in repeated measures|Mean Difference (Net)|-1.074||||0.0958|TWO_SIDED|95.0|-2.255|0.1059||The threshold for statistical significance was p = 0.05.|ANOVA|p Values were adjusted for multiple comparisons using Tukey-Kramer tests.|Difference = StdDevY (Typical) - StdDevY (Atypical)|||0.1059|-2.255|0.0958
72349599|NCT02813889|144220334|SUPERIORITY|Two-Factor ANOVA in repeated measures|Mean Difference (Net)|0.5248||||0.966|TWO_SIDED|95.0|-1.1243|2.1739||The threshold for statistical significance was p = 0.05.|ANOVA|p Values were adjusted for multiple comparisons using Tukey-Kramer tests.|Difference = StdDevY (Typical) - StdDevY (Atypical)|||2.1739|-1.1243|0.9660
72349600|NCT02813889|144220335|SUPERIORITY|Two-Factor ANOVA in repeated measures|Mean Difference (Net)|-0.4198||||0.9462|TWO_SIDED|95.0|-1.6278|0.7882||The threshold for statistical significance was p = 0.05.|ANOVA|p Values were adjusted for multiple comparisons using Tukey-Kramer tests.|Difference = StdDevY (Typical) - StdDevY (Atypical)|||0.7882|-1.6278|0.9462
72349601|NCT02813889|144220336|SUPERIORITY|Two-Factor ANOVA in repeated measures|Mean Difference (Net)|-1.0705||||0.1129|TWO_SIDED|95.0|-2.2785|0.1375||The threshold for statistical significance was p = 0.05.|ANOVA|p Values were adjusted for multiple comparisons using Tukey-Kramer tests.|Difference = StdDevY (Typical) - StdDevY (Atypical)|||0.1375|-2.2785|0.1129
72349602|NCT03671213|144220351|SUPERIORITY|Non-inferiority is demonstrated if the 90% LB \> -10.0%. If non-inferiority was met, superiority could be tested. Superiority is demonstrated if 97.5% LB \> 0.0%.||||||||||||||||For missing data in both Arms/Groups, multiple imputation was performed for the primary CCS analysis|Device group differences and two-sided 90% and 97.5% confidence interval lower bounds (LB) adjusting for propensity score (PS) subclass based on PS subclass weights (ATT). Non-inferiority is demonstrated if the 90% LB \> -10.0%. Superiority is demonstrated if 97.5% LB \> 0.0%. Two-sided 97.5% LB is evaluated rather than two-sided 95.0% LB since the superiority type 1 error is split between testing superiority in terms of Month 24 CCS and then separately for a set of superiority secondary endpoints with type 1 error control maintained through the use of Hochberg approach (following demonstration of non-inferiority).|||
72349603|NCT01717872|144220361|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||MAC blade lifting the tongue versus Miller blade lifting the epiglottis||||>0.05
72349604|NCT01717872|144220362|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||||||>0.05
72349605|NCT01717872|144220363|SUPERIORITY_OR_OTHER||||||<|0.0004|||||||Wilcoxon (Mann-Whitney)|||||||<0.0004
72349606|NCT03078556|144220364|OTHER||Ratio|1.271|||||TWO_SIDED|90.0|1.1894|1.3582|||||Ratio (B/A) of plasma DTG has been presented.|||1.3582|1.1894|
72349607|NCT03078556|144220364|OTHER||Ratio|1.0341|||||TWO_SIDED|90.0|1.0097|1.0591|||||Ratio (B/A) of plasma 3TC has been presented.|||1.0591|1.0097|
72349608|NCT03078556|144220365|OTHER||Ratio|1.155|||||TWO_SIDED|90.0|1.0699|1.2468|||||Ratio (C/A) of plasma DTG has been presented.|||1.2468|1.0699|
72349609|NCT03078556|144220365|OTHER||Ratio|1.0635|||||TWO_SIDED|90.0|1.0413|1.0861|||||Ratio (C/A) of plasma 3TC has been presented.|||1.0861|1.0413|
72349610|NCT03078556|144220366|OTHER||Ratio|1.2756|||||TWO_SIDED|90.0|1.1919|1.3651|||||Ratio (B/A) of plasma DTG has been presented.|||1.3651|1.1919|
72349611|NCT03078556|144220366|OTHER||Ratio|1.0372|||||TWO_SIDED|90.0|1.0116|1.0634|||||Ratio (B/A) of plasma 3TC has been presented.|||1.0634|1.0116|
72349612|NCT03078556|144220367|OTHER||Ratio|1.1578|||||TWO_SIDED|90.0|1.0718|1.2507|||||Ratio (C/A) of plasma DTG has been presented.|||1.2507|1.0718|
72349613|NCT03078556|144220367|OTHER||Ratio|1.0702|||||TWO_SIDED|90.0|1.0464|1.0946|||||Ratio (C/A) of plasma 3TC has been presented.|||1.0946|1.0464|
72349614|NCT03078556|144220368|OTHER||Ratio|1.2805|||||TWO_SIDED|90.0|1.189|1.379|||||Ratio (B/A) of plasma DTG has been presented.|||1.3790|1.1890|
72349615|NCT03078556|144220368|OTHER||Ratio|1.1956|||||TWO_SIDED|90.0|1.1437|1.2498|||||Ratio (B/A) of plasma 3TC has been presented.|||1.2498|1.1437|
72349616|NCT03078556|144220369|OTHER||Ratio|1.141|||||TWO_SIDED|90.0|1.0533|1.2361|||||Ratio (C/A) of plasma DTG has been presented.|||1.2361|1.0533|
72349617|NCT03078556|144220369|OTHER||Ratio|1.3176|||||TWO_SIDED|90.0|1.2616|1.376|||||Ratio (C/A) of plasma 3TC has been presented.|||1.3760|1.2616|
72349618|NCT03078556|144220370|OTHER||Median Difference (Final Values)|0.0|||||TWO_SIDED|90.0|0.0|0.0|||||Median Difference of plasma DTG has been presented.|||0.000|0.000|
72349619|NCT03078556|144220370|OTHER||Median Difference (Final Values)|0.0|||||TWO_SIDED|90.0|0.0|0.0|||||Median Difference of plasma 3TC has been presented.|||0.000|0.000|
72349620|NCT03078556|144220371|OTHER||Median Difference (Final Values)|0.0|||||TWO_SIDED|90.0|-0.004|0.0|||||Median Difference of plasma DTG has been presented.|||0.000|-0.004|
72349621|NCT03078556|144220371|OTHER||Median Difference (Final Values)|0.0|||||TWO_SIDED|90.0|0.0|0.0|||||Median Difference of plasma 3TC has been presented.|||0.000|0.000|
72349622|NCT03078556|144220372|OTHER||Median Difference (Final Values)|-0.127|||||TWO_SIDED|90.0|-0.5|0.248|||||Median Difference of plasma DTG has been presented.|||0.248|-0.500|
72349623|NCT03078556|144220372|OTHER||Median Difference (Final Values)|-0.126|||||TWO_SIDED|90.0|-0.253|-0.001|||||Median Difference of plasma 3TC has been presented.|||-0.001|-0.253|
72349624|NCT03078556|144220373|OTHER||Median Difference (Final Values)|-0.127|||||TWO_SIDED|90.0|-0.497|0.132|||||Median Difference of plasma DTG has been presented.|||0.132|-0.497|
72349625|NCT03078556|144220373|OTHER||Median Difference (Final Values)|-0.248|||||TWO_SIDED|90.0|-0.376|-0.001|||||Median Difference of plasma 3TC has been presented.|||-0.001|-0.376|
72349626|NCT03078556|144220382|OTHER||Ratio|1.2774|||||TWO_SIDED|90.0|1.1931|1.3676|||||Ratio (B/A) of plasma DTG has been presented.|||1.3676|1.1931|
72349627|NCT03078556|144220382|OTHER||Ratio|1.0475|||||TWO_SIDED|90.0|1.0185|1.0773|||||Ratio (B/A) of plasma 3TC has been presented.|||1.0773|1.0185|
72349628|NCT03078556|144220383|OTHER||Ratio|1.1599|||||TWO_SIDED|90.0|1.0711|1.256|||||Ratio (C/A) of plasma DTG has been presented.|||1.2560|1.0711|
72349629|NCT03078556|144220383|OTHER||Ratio|1.0807|||||TWO_SIDED|90.0|1.0539|1.1081|||||Ratio (C/A) of plasma 3TC has been presented.|||1.1081|1.0539|
72349630|NCT03078556|144220384|OTHER||Ratio|0.7868|||||TWO_SIDED|90.0|0.7363|0.8408|||||Ratio (B/A) of plasma DTG has been presented.|||0.8408|0.7363|
72349631|NCT03078556|144220384|OTHER||Ratio|0.967|||||TWO_SIDED|90.0|0.9442|0.9904|||||Ratio (B/A) of plasma 3TC has been presented.|||0.9904|0.9442|
72349632|NCT03078556|144220385|OTHER||Ratio|0.8658|||||TWO_SIDED|90.0|0.8021|0.9347|||||Ratio (C/A) of plasma DTG has been presented.|||0.9347|0.8021|
72349633|NCT03078556|144220385|OTHER||Ratio|0.9403|||||TWO_SIDED|90.0|0.9207|0.9604|||||Ratio (C/A) of plasma 3TC has been presented.|||0.9604|0.9207|
72349634|NCT03078556|144220386|OTHER||Ratio|0.7859|||||TWO_SIDED|90.0|0.7318|0.844|||||Ratio (B/A) of plasma DTG has been presented.|||0.8440|0.7318|
72349635|NCT03078556|144220386|OTHER||Ratio|0.9704|||||TWO_SIDED|90.0|0.9157|1.0284|||||Ratio (B/A) of plasma 3TC has been presented.|||1.0284|0.9157|
72349636|NCT03078556|144220387|OTHER||Ratio|0.8571|||||TWO_SIDED|90.0|0.7914|0.9282|||||Ratio (C/A) of plasma DTG has been presented.|||0.9282|0.7914|
72349637|NCT03078556|144220387|OTHER||Ratio|0.9153|||||TWO_SIDED|90.0|0.8613|0.9728|||||Ratio (C/A) of plasma 3TC has been presented.|||0.9728|0.8613|
72349638|NCT03078556|144220388|OTHER||Ratio|1.2632|||||TWO_SIDED|90.0|1.1811|1.3511|||||Ratio (B/A) of plasma DTG has been presented.|||1.3511|1.1811|
72349639|NCT03078556|144220388|OTHER||Ratio|0.9598|||||TWO_SIDED|90.0|0.9268|0.9941|||||Ratio (B/A) of plasma 3TC has been presented.|||0.9941|0.9268|
72349640|NCT03078556|144220389|OTHER||Ratio|1.1425|||||TWO_SIDED|90.0|1.0597|1.2317|||||Ratio (C/A) of plasma DTG has been presented.|||1.2317|1.0597|
72349641|NCT03078556|144220389|OTHER||Ratio|0.9548|||||TWO_SIDED|90.0|0.9299|0.9804|||||Ratio (C/A) of plasma 3TC has been presented.|||0.9804|0.9299|
72349642|NCT03078556|144220390|OTHER||Ratio|1.1839|||||TWO_SIDED|90.0|1.0921|1.2834|||||Ratio (B/A) of plasma DTG has been presented|||1.2834|1.0921|
72349643|NCT03078556|144220390|OTHER||Ratio|0.8874|||||TWO_SIDED|90.0|0.834|0.9443|||||Ratio (B/A) of plasma 3TC has been presented|||0.9443|0.8340|
72349644|NCT03078556|144220391|OTHER||Ratio|1.078|||||TWO_SIDED|90.0|0.9958|1.167|||||Ratio (B/A) of plasma DTG has been presented|||1.1670|0.9958|
72349645|NCT03078556|144220391|OTHER||Ratio|0.9049|||||TWO_SIDED|90.0|0.8474|0.9663|||||Ratio (B/A) of plasma 3TC has been presented|||0.9663|0.8474|
72349646|NCT03078556|144220392|OTHER||Ratio|1.1545|||||TWO_SIDED|90.0|1.0208|1.3058|||||Ratio (Bfed/B) of plasma DTG has been presented|||1.3058|1.0208|
72349647|NCT03078556|144220392|OTHER||Ratio|0.9577|||||TWO_SIDED|90.0|0.9126|1.0049|||||Ratio (Bfed/B) of plasma 3TC has been presented|||1.0049|0.9126|
72349648|NCT03078556|144220393|OTHER||Ratio|1.3256|||||TWO_SIDED|90.0|1.1837|1.4845|||||Ratio (Cfed/C) of plasma DTG has been presented|||1.4845|1.1837|
72349649|NCT03078556|144220393|OTHER||Ratio|0.9114|||||TWO_SIDED|90.0|0.8658|0.9593|||||Ratio (Cfed/C) of plasma 3TC has been presented|||0.9593|0.8658|
72349650|NCT03078556|144220394|OTHER||Ratio|1.1481|||||TWO_SIDED|90.0|1.0154|1.2982|||||Ratio (Bfed/B) of plasma DTG has been presented|||1.2982|1.0154|
72349651|NCT03078556|144220394|OTHER||Ratio|0.9524|||||TWO_SIDED|90.0|0.9086|0.9983|||||Ratio (Bfed/B) of plasma 3TC has been presented|||0.9983|0.9086|
72429151|NCT01474512|144369236|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||LS mean and P-value were calculated using MMRM with baseline score as a covariate, treatment, geographic region, previous non-biologic systemic therapy, baseline weight category, visit and treatment-by-visit interaction as fixed effects.|Mixed Models Analysis|||||||<0.001
72429152|NCT01474512|144369236|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||LS mean and P-value were calculated using MMRM with baseline score as a covariate, treatment, geographic region, previous non-biologic systemic therapy, baseline weight category, visit and treatment-by-visit interaction as fixed effects.|Mixed Models Analysis|||||||<0.001
72349652|NCT03078556|144220395|OTHER||Ratio|1.3176|||||TWO_SIDED|90.0|1.175|1.4775|||||Ratio (Cfed/C) of plasma DTG has been presented|||1.4775|1.1750|
72349653|NCT03078556|144220395|OTHER||Ratio|0.9048|||||TWO_SIDED|90.0|0.8592|0.9528|||||Ratio (Cfed/C) of plasma 3TC has been presented|||0.9528|0.8592|
72349654|NCT03078556|144220396|OTHER||Ratio|1.0808|||||TWO_SIDED|90.0|0.9527|1.2261|||||Ratio (Bfed/B) of plasma DTG has been presented|||1.2261|0.9527|
72349655|NCT03078556|144220396|OTHER||Ratio|0.7097|||||TWO_SIDED|90.0|0.6474|0.7779|||||Ratio (Bfed/B) of plasma 3TC has been presented|||0.7779|0.6474|
72349656|NCT03078556|144220397|OTHER||Ratio|1.2096|||||TWO_SIDED|90.0|1.0521|1.3908|||||Ratio (Cfed/C) of plasma DTG has been presented|||1.3908|1.0521|
72349657|NCT03078556|144220397|OTHER||Ratio|0.6826|||||TWO_SIDED|90.0|0.5861|0.795|||||Ratio (Cfed/C) of plasma 3TC has been presented|||0.7950|0.5861|
72349658|NCT03078556|144220398|OTHER||Median Difference (Final Values)|0.254|||||TWO_SIDED|90.0|0.25|0.378|||||Median Difference of plasma DTG has been presented|||0.378|0.250|
72349659|NCT03078556|144220398|OTHER||Median Difference (Final Values)|0.125|||||TWO_SIDED|90.0|0.0|0.127|||||Median Difference of plasma 3TC has been presented|||0.127|0.000|
72349660|NCT03078556|144220399|OTHER||Median Difference (Final Values)|0.126|||||TWO_SIDED|90.0|0.0|0.25|||||Median Difference of plasma DTG has been presented|||0.250|0.000|
72349661|NCT03078556|144220399|OTHER||Median Difference (Final Values)|0.0|||||TWO_SIDED|90.0|0.0|0.125|||||Median Difference of plasma 3TC has been presented|||0.125|0.000|
72349662|NCT03078556|144220400|OTHER||Median Difference (Final Values)|3.017|||||TWO_SIDED|90.0|1.872|4.496|||||Median Difference of plasma DTG has been presented|||4.496|1.872|
72349663|NCT03078556|144220400|OTHER||Median Difference (Final Values)|2.113|||||TWO_SIDED|90.0|1.5|2.751|||||Median Difference of plasma 3TC has been presented|||2.751|1.500|
72349664|NCT03078556|144220401|OTHER||Median Difference (Final Values)|2.5|||||TWO_SIDED|90.0|1.748|3.751|||||Median Difference of plasma DTG has been presented|||3.751|1.748|
72349665|NCT03078556|144220401|OTHER||Median Difference (Final Values)|1.503|||||TWO_SIDED|90.0|0.998|2.252|||||Median Difference of plasma 3TC has been presented|||2.252|0.998|
72349666|NCT03078556|144220410|OTHER||Ratio|1.0849|||||TWO_SIDED|90.0|0.9613|1.2245|||||Ratio (Bfed/B) of plasma DTG has been presented|||1.2245|0.9613|
72349667|NCT03078556|144220410|OTHER||Ratio|0.9363|||||TWO_SIDED|90.0|0.8913|0.9836|||||Ratio (Bfed/B) of plasma 3TC has been presented|||0.9836|0.8913|
72349668|NCT03078556|144220411|OTHER||Median Difference (Final Values)|1.2477|||||TWO_SIDED|90.0|1.1013|1.4136|||||Median Difference of plasma DTG has been presented|||1.4136|1.1013|
72349669|NCT03078556|144220411|OTHER||Median Difference (Final Values)|0.8836|||||TWO_SIDED|90.0|0.8351|0.935|||||Median Difference of plasma 3TC has been presented|||0.9350|0.8351|
72349670|NCT03078556|144220412|OTHER||Ratio|0.8661|||||TWO_SIDED|90.0|0.7658|0.9796|||||Ratio (Bfed/B) of plasma DTG has been presented|||0.9796|0.7658|
72349671|NCT03078556|144220412|OTHER||Ratio|1.0442|||||TWO_SIDED|90.0|0.9951|1.0957|||||Ratio (Bfed/B) of plasma 3TC has been presented|||1.0957|0.9951|
72349672|NCT03078556|144220413|OTHER||Ratio|0.7544|||||TWO_SIDED|90.0|0.6736|0.8448|||||Ratio (Cfed/C) of plasma DTG has been presented|||0.8448|0.6736|
72349673|NCT03078556|144220413|OTHER||Ratio|1.0972|||||TWO_SIDED|90.0|1.0424|1.155|||||Ratio (Cfed/C) of plasma 3TC has been presented|||1.1550|1.0424|
72349674|NCT03078556|144220416|OTHER||Ratio|0.8654|||||TWO_SIDED|90.0|0.7629|0.9816|||||Ratio (Bfed/B) of plasma DTG has been presented|||0.9816|0.7629|
72349675|NCT03078556|144220416|OTHER||Ratio|1.0841|||||TWO_SIDED|90.0|0.9139|1.286|||||Ratio (Bfed/B) of plasma 3TC has been presented|||1.2860|0.9139|
72349676|NCT03078556|144220417|OTHER||Ratio|0.7657|||||TWO_SIDED|90.0|0.6702|0.8749|||||Ratio (Cfed/C) of plasma DTG has been presented|||0.8749|0.6702|
72349677|NCT03078556|144220417|OTHER||Ratio|1.197|||||TWO_SIDED|90.0|1.0869|1.3182|||||Ratio (Cfed/C) of plasma 3TC has been presented|||1.3182|1.0869|
72349678|NCT03078556|144220418|OTHER||Ratio|1.2929|||||TWO_SIDED|90.0|1.1281|1.4819|||||Ratio (Bfed/B) of plasma DTG has been presented|||1.4819|1.1281|
72349679|NCT03078556|144220418|OTHER||Ratio|1.2015|||||TWO_SIDED|90.0|1.1074|1.3036|||||Ratio (Bfed/B) of plasma 3TC has been presented|||1.3036|1.1074|
72349680|NCT03078556|144220419|OTHER||Ratio|1.469|||||TWO_SIDED|90.0|1.3009|1.6588|||||Ratio (Cfed/C) of plasma DTG has been presented|||1.6588|1.3009|
72349681|NCT03078556|144220419|OTHER||Ratio|1.1935|||||TWO_SIDED|90.0|1.1142|1.2785|||||Ratio (Cfed/C) of plasma 3TC has been presented|||1.2785|1.1142|
72349682|NCT01915173|144220452|SUPERIORITY_OR_OTHER|||||||0.01|TWO_SIDED||||||Regression, Logistic|||All 4 arms were combined to compare the Standard Interview groups to the Expanded Interview groups. We calculated that we had 45-74% power to detect a 30-40% difference in responders between groups in the pre-specified primary outcome measure, the percent of subjects with a 50% or greater improvement in GERD symptom severity.||||0.01
72349683|NCT01915173|144220452|SUPERIORITY_OR_OTHER|||||||0.33|TWO_SIDED||||||Regression, Logistic|||All 4 arms were combined to compare the Placebo groups to the Supplement groups. We calculated that we had 45-74% power to detect a 30-40% difference in responders between groups in the pre-specified primary outcome measure, the percent of subjects with a 50% or greater improvement in GERD symptom severity.||||0.33
72349684|NCT01290757|144220462|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence (BE). Scaled average BE is rejected, if the calculated upper 95% confidence limit of the linearized criterion is positive.|Upper 95% CI of the linearized criterion|-0.082|||||ONE_SIDED|95.0|||||Mixed Models Analysis||Linearized regulatory criterion according to Tothfalusi et al (Pharmaceutical Research, 2001). The square of the difference in treatment responses divided by within-subject variance of the reference formulation minus square of ln(1.25)/0.25|Capsugel minus Qualicaps||||
72349685|NCT01290757|144220462|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence (BE). Bioequivalence is accepted if 90% confidence interval lies within the common BE margins (80% and 125%).|Adjusted geometric mean ratio (%)|126.33||||||90.0|119.45|133.6|||Mixed Models Analysis|||Capsugel vs Qualicaps||133.60|119.45|
72349686|NCT01290757|144220463|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence (BE). Scaled average BE is rejected, if the calculated upper 95% confidence limit of the linearized criterion is positive.|Upper 95% CI of the linearized criterion|-0.085|||||ONE_SIDED|95.0|||||Mixed Models Analysis||Linearized regulatory criterion according to Tothfalusi et al (Pharmaceutical Research, 2001). The square of the difference in treatment responses divided by within-subject variance of the reference formulation minus square of ln(1.25)/0.25|Capsugel minus Qualicaps||||
72349687|NCT01290757|144220463|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence (BE). Bioequivalence is accepted if 90% confidence interval lies within the common BE margins (80% and 125%).|Adjusted geometric mean ratio (%)|125.49||||||90.0|118.69|132.67|||Mixed Models Analysis|||Capsugel vs Qualicaps||132.67|118.69|
72349688|NCT01290757|144220464|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence (BE). Bioequivalence is accepted if 90% confidence interval lies within the common BE margins (80% and 125%).|Adjusted geometric mean ratio (%)|124.74||||||90.0|118.32|131.51|||Mixed Models Analysis|||Capsugel vs Qualicaps||131.51|118.32|
72349689|NCT01290757|144220465|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence (BE). Bioequivalence is accepted if 90% confidence interval lies within the common BE margins (80% and 125%).|Adjusted geometric mean ratio (%)|126.22||||||90.0|119.36|133.47|||Mixed Models Analysis|||Capsugel vs Qualicaps||133.47|119.36|
72349690|NCT01290757|144220466|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence (BE). Bioequivalence is accepted if 90% confidence interval lies within the common BE margins (80% and 125%).|Adjusted geometric mean ratio (%)|125.3||||||90.0|118.42|132.59|||Mixed Models Analysis|||Capsugel vs Qualicaps||132.59|118.42|
72349691|NCT01290757|144220467|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence (BE). Bioequivalence is accepted if 90% confidence interval lies within the common BE margins (80% and 125%).|Adjusted geometric mean ratio (%)|124.49||||||90.0|118.11|131.21|||Mixed Models Analysis|||Capsugel vs Qualicaps||131.21|118.11|
72349692|NCT00887549|144220468|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.015|||<|0.0001|TWO_SIDED|95.0|1.008|1.021|||Regression, Cox|The Cox model, based upon participant level data, included PFS as dependent variable and TS score in the nucleus as independent variable.||||1.021|1.008|<0.0001
72349693|NCT00759161|144220480|SUPERIORITY_OR_OTHER||||||<|0.001|||||||2-sided sign test|||||||< 0.001
72349694|NCT00479336|144220487|SUPERIORITY_OR_OTHER||Slope|-0.021|STANDARD_ERROR_OF_MEAN|0.02||0.3167|TWO_SIDED|95.0|-0.061|0.02|||Regression, Linear|||A linear regression model using change in body weight from baseline at the final timepoint as the criterion variable and dose as the explanatory variable was fitted to the dataset. The null hypothesis of whether the regression coefficient is zero (analysis using t-statistics) was tested at a two-tailed significance level of 0.05, and estimated values for the slope and 95% confidence interval were calculated.||0.020|-0.061|0.3167
72349695|NCT02631551|144220499|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||GSP 301 NS vs GSP 301 placebo NS comparison for rTNSS was tested at 0.05 significance level.||||<0.0001
72349696|NCT02631551|144220499|SUPERIORITY|||||||0.0029|||||||Mixed Models Analysis|||GSP 301 NS vs Olopatadine HCl NS comparison for rTNSS was tested at 0.05 significance level.||||0.0029
72349697|NCT02631551|144220499|SUPERIORITY|||||||0.0587|||||||Mixed Models Analysis|||GSP 301 NS vs Mometasone furoate NS comparison for rTNSS was tested at 0.05 significance level.||||0.0587
72429153|NCT01474512|144369237|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||P-value is for PPASI50.|Regression, Logistic|Logistic Regression analysis included treatment, geographic region, previous non-biologic systemic therapy and baseline weight category as factors.||||||<0.001
72429154|NCT01474512|144369237|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||P-value is for PPASI50.|Regression, Logistic|Logistic Regression analysis included treatment, geographic region, previous non-biologic systemic therapy and baseline weight category as factors.||||||<0.001
72429155|NCT01474512|144369237|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||P-value is for PPASI75|Regression, Logistic|Logistic Regression analysis included treatment, geographic region, previous non-biologic systemic therapy and baseline weight category as factors.||||||<0.001
72429156|NCT01474512|144369237|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||P-value is for PPASI75|Regression, Logistic|Logistic Regression analysis included treatment, geographic region, previous non-biologic systemic therapy and baseline weight category as factors.||||||<0.001
72349698|NCT02631551|144220499|SUPERIORITY|||||||0.0755|||||||Mixed Models Analysis|||Olopatadine HCl NS vs GSP 301 Placebo NS comparison for rTNSS was tested at 0.05 significance level.||||0.0755
72349699|NCT02631551|144220499|SUPERIORITY|||||||0.0043|||||||Mixed Models Analysis|||Mometasone furoate NS vs GSP 301 Placebo NS comparison for rTNSS was tested at 0.05 significance level.||||0.0043
72349700|NCT04112303|144220500|SUPERIORITY||||||<|0.001|||||||2-sided exact 1-sample binomial test|||The SVR12 rate was compared to the pre-specified efficacy threshold of 78% using a 2-sided exact 1-sample binomial test at the 0.05 significance level.||||<0.001
72349701|NCT01318408|144220510|NON_INFERIORITY_OR_EQUIVALENCE|Assessing effects on cognition over time.||||||0.01|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||The intent-to-treat group included all individuals who initiated levetiracetam. The Mann-Whitney U test was used to determine changes in participants' scores for cognition, function, and behavior between baseline and 12 weeks.Change in MMSE test scores was the primary outcome measure.||||.01
72349702|NCT01318408|144220511|NON_INFERIORITY_OR_EQUIVALENCE|Assessing cognitive effects over time.||||||0.02|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|Lower scores (negative change) indicate improvements on the ADAS-cog.||||||.02
72349703|NCT00377858|144220513|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority margin of 0.3% based on prior studies indicating an HbA1c difference of 0.6% in patients treated with lispro and sulfonylurea compared with those treated with sulfonylurea and metformin.|Mean Difference (Net)|0.17||||0.097||95.0|-0.03|0.37|||ANCOVA|ANCOVA Model: Variable=Treatment + Baseline HbA1c Stratum + Sulfonylurea stratum + Country + Baseline HbA1c Stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for (Insulin Lispro Mid Mixture minus Insulin Glargine).|Assuming 15% drop-out rate after randomization, remaining 213 patients in each treatment group would allow confirmation of noninferiority with no treatment difference and a noninferiority limit of 0.3% using upper limit of 2-sided confidence interval at significance level of 0.05 with 80% power.||0.37|-0.03|0.097
72349704|NCT00377858|144220514|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.16||||0.047||95.0|0.0|0.33||P-value for 12 Week Interval.|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline HbA1c + Baseline HbA1c stratum + Sulfonylurea stratum + Country.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||0.33|0.00|0.047
72349705|NCT00377858|144220514|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.18||||0.043||95.0|0.01|0.35||P-value for 24 Week Interval.|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline HbA1c + Baseline HbA1c stratum + Sulfonylurea stratum + Country.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||0.35|0.01|0.043
72349706|NCT00377858|144220514|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.1||||0.343||95.0|-0.1|0.29||P-value for 36 Week Interval.|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline HbA1c + Baseline HbA1c stratum + Sulfonylurea stratum + Country.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||0.29|-0.10|0.343
72349707|NCT00377858|144220515|SUPERIORITY_OR_OTHER|||||||0.432||95.0||||P-value for Week 12: HbA1c ≤7.0%.|Regression, Logistic|Logistic Regression Model: Variable=Treatment + Baseline HbA1c + Country + Sulfonylurea Stratum.||||||0.432
72349708|NCT00377858|144220515|SUPERIORITY_OR_OTHER|||||||0.602||95.0||||P-value for 12 Week: HbA1c \<7.0%.|Regression, Logistic|Logistic Regression Model: Variable=Treatment + Baseline HbA1c + Country + Sulfonylurea Stratum.||||||0.602
72349709|NCT00377858|144220515|SUPERIORITY_OR_OTHER|||||||0.37||95.0||||P-value for 12 Week: HbA1c ≤6.5%.|Regression, Logistic|Logistic Regression Model: Variable=Treatment + Baseline HbA1c + Country + Sulfonylurea Stratum.||||||0.370
72349710|NCT00377858|144220515|SUPERIORITY_OR_OTHER|||||||0.198||95.0||||P-value for 24 Week: HbA1c ≤7.0%.|Regression, Logistic|Logistic Regression Model: Variable=Treatment + Baseline HbA1c + Country + Sulfonylurea Stratum.||||||0.198
72349711|NCT00377858|144220515|SUPERIORITY_OR_OTHER|||||||0.636||95.0||||P-value for 24 Week: HbA1c \<7.0%.|Regression, Logistic|Logistic Regression Model: Variable=Treatment + Baseline HbA1c + Country + Sulfonylurea Stratum.||||||0.636
72349712|NCT00377858|144220515|SUPERIORITY_OR_OTHER|||||||0.185||95.0||||P-value for 24 Week: HbA1c ≤6.5%.|Regression, Logistic|Logistic Regression Model: Variable=Treatment + Baseline HbA1c + Country + Sulfonylurea Stratum.||||||0.185
72349713|NCT00377858|144220515|SUPERIORITY_OR_OTHER|||||||0.393||95.0||||P-value for 36 Week: HbA1c ≤7.0%.|Regression, Logistic|Logistic Regression Model: Variable=Treatment + Baseline HbA1c + Country + Sulfonylurea Stratum.||||||0.393
72349714|NCT00377858|144220515|SUPERIORITY_OR_OTHER|||||||0.739||95.0||||P-value for 36 Week: HbA1c \<7.0%.|Regression, Logistic|Logistic Regression Model: Variable=Treatment + Baseline HbA1c + Country + Sulfonylurea Stratum.||||||0.739
72349715|NCT00377858|144220515|SUPERIORITY_OR_OTHER|||||||0.396||95.0||||P-value for 36 Week: HbA1c ≤6.5%.|Regression, Logistic|Logistic Regression Model: Variable=Treatment + Baseline HbA1c + Country + Sulfonylurea Stratum.||||||0.396
72349716|NCT00377858|144220515|SUPERIORITY_OR_OTHER|||||||0.227||95.0||||P-value for Endpoint (LOCF): HbA1c ≤7.0%.|Regression, Logistic|Logistic Regression Model: Variable=Treatment + Baseline HbA1c + Country + Sulfonylurea Stratum.||||||0.227
72349717|NCT00377858|144220515|SUPERIORITY_OR_OTHER|||||||0.482||95.0||||P-value for Endpoint (LOCF): HbA1c \<7.0%.|Regression, Logistic|Logistic Regression Model: Variable=Treatment + Baseline HbA1c + Country + Sulfonylurea Stratum.||||||0.482
72349718|NCT00377858|144220515|SUPERIORITY_OR_OTHER|||||||0.108||95.0||||P-value for Endpoint (LOCF): HbA1c ≤6.5%.|Regression, Logistic|Logistic Regression Model: Variable=Treatment + Baseline HbA1c + Country + Sulfonylurea Stratum.||||||0.108
72349719|NCT00377858|144220516|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.58||||0.014||95.0|0.12|1.04||P-value for Baseline: Morning Pre-Meal.|ANOVA|ANOVA Model: Variable=Treatment + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||1.04|0.12|0.014
72349720|NCT00377858|144220516|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.11||||0.735||95.0|-0.51|0.72||P-value for Baseline: Morning Postprandial Meal.|ANOVA|ANOVA Model: Variable=Treatment + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||0.72|-0.51|0.735
72429157|NCT01474512|144369237|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||P-value is for PPASI100|Regression, Logistic|Logistic Regression analysis included treatment, geographic region, previous non-biologic systemic therapy and baseline weight category as factors.||||||<0.001
72429158|NCT01474512|144369237|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||P-value if for PPASI100.|Regression, Logistic|Logistic Regression analysis included treatment, geographic region, previous non-biologic systemic therapy and baseline weight category as factors.||||||<0.001
72349721|NCT00377858|144220516|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.54||||0.051||95.0|0.0|1.08||P-value for Baseline: Midday Pre-Meal.|ANOVA|ANOVA Model: Variable=Treatment + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||1.08|-0.00|0.051
72349722|NCT00377858|144220516|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.18||||0.536||95.0|-0.39|0.75||P-value for Baseline: Midday Postprandial Meal.|ANOVA|ANOVA Model: Variable=Treatment + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||0.75|-0.39|0.536
72349723|NCT00377858|144220516|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.07||||0.793||95.0|-0.48|0.62||P-value for Baseline: Evening Pre-Meal.|ANOVA|ANOVA Model: Variable=Treatment + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||0.62|-0.48|0.793
72349724|NCT00377858|144220516|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.11||||0.693||95.0|-0.43|0.64||P-value for Baseline: Evening Postprandial Meal.|ANOVA|ANOVA Model: Variable=Treatment + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||0.64|-0.43|0.693
72349725|NCT00377858|144220516|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.2||||0.499||95.0|-0.38|0.77||P-value for Baseline: 0300 Hours.|ANOVA|ANOVA Model: Variable=Treatment + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||0.77|-0.38|0.499
72349726|NCT00377858|144220516|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.59|||<|0.001||95.0|0.26|0.92||P-value for 12 Week: Morning Pre-Meal.|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||0.92|0.26|<0.001
72349727|NCT00377858|144220516|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.28||||0.278||95.0|-0.22|0.78||P-value for 12 Week: Morning Postprandial Meal.|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||0.78|-0.22|0.278
72349728|NCT00377858|144220516|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.53||||0.009||95.0|0.14|0.93||P-value for 12 Week: Midday Pre-Meal.|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||0.93|0.14|0.009
72349729|NCT00377858|144220516|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.49||||0.049||95.0|0.0|0.97||P-value for 12 Week: Midday Postprandial Meal.|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||0.97|0.00|0.049
72349730|NCT00377858|144220516|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.77|||<|0.001||95.0|0.35|1.18||P-value for 12 Week: Evening Pre-Meal.|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||1.18|0.35|<0.001
72349731|NCT00377858|144220516|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.17|||<|0.001||95.0|-1.63|-0.7||P-value for 12 Week: Evening Postprandial Meal.|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||-0.70|-1.63|<0.001
72349732|NCT00377858|144220516|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.15||||0.506||95.0|-0.59|0.29||P-value for 12 Week: 0300 Hours.|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||0.29|-0.59|0.506
72349733|NCT00377858|144220516|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.65|||<|0.001||95.0|0.31|0.99||P-value for 24 Week: Morning Pre-Meal.|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||0.99|0.31|<0.001
72349734|NCT00377858|144220516|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.42||||0.094||95.0|-0.07|0.91||P-value for 24 Week: Morning Postprandial Meal.|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||0.91|-0.07|0.094
72349735|NCT00377858|144220516|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.17||||0.408||95.0|-0.24|0.59||P-value for 24 Week: Midday Pre-Meal.|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||0.59|-0.24|0.408
72429159|NCT03249376|144369308|SUPERIORITY||Least Squares Mean Difference|-4.6|STANDARD_ERROR_OF_MEAN|0.89|<|0.0001|TWO_SIDED|95.0|-6.34|-2.83|||Mixed Effects Model for Repeated Measure|||||-2.83|-6.34|<0.0001
72349736|NCT00377858|144220516|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.23||||0.351||95.0|-0.25|0.71||P-value for 24 Week: Midday Postprandial Meal.|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||0.71|-0.25|0.351
72349737|NCT00377858|144220516|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.56||||0.01||95.0|0.13|0.98||P-value for 24 Week: Evening Pre-Meal.|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||0.98|0.13|0.010
72349738|NCT00377858|144220516|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.48||||0.029||95.0|-0.92|-0.05||P-value for 24 Week: Evening Postprandial Meal.|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||-0.05|-0.92|0.029
72349739|NCT00377858|144220516|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.05||||0.816||95.0|-0.45|0.35||P-value for 24 Week: 0300 Hours.|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||0.35|-0.45|0.816
72349740|NCT00377858|144220516|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.49||||0.008||95.0|0.13|0.85||P-value for 36 Week: Morning Pre-Meal.|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||0.85|0.13|0.008
72349741|NCT00377858|144220516|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.2||||0.438||95.0|-0.71|0.31||P-value for 36 Week: Morning Postprandial Meal.|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||0.31|-0.71|0.438
72349742|NCT00377858|144220516|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.13||||0.548||95.0|-0.54|0.29||P-value for 36 Week: Midday Pre-Meal.|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||0.29|-0.54|0.548
72349743|NCT00377858|144220516|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.01||||0.964||95.0|-0.5|0.52||P-value for 36 Week: Midday Postprandial Meal.|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||0.52|-0.50|0.964
72349744|NCT00377858|144220516|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.16||||0.453||95.0|-0.27|0.6||P-value for 36 Week: Evening Pre-Meal.|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||0.60|-0.27|0.453
72349745|NCT00377858|144220516|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.39||||0.096||95.0|-0.84|0.07||P-value for 36 Week: Evening Postprandial Meal.|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||0.07|-0.84|0.096
72349746|NCT00377858|144220516|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.07||||0.77||95.0|-0.51|0.37||P-value for 36 Week: 0300 Hours.|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||0.37|-0.51|0.770
72349747|NCT00377858|144220516|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.45||||0.01||95.0|0.11|0.8||P-value for Endpoint: Morning Pre-Meal. (last observation carried forward)|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||0.80|0.11|0.010
72349748|NCT00377858|144220516|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.31||||0.201||95.0|-0.8|0.17||P-value for Endpoint: Morning Postprandial Meal. (last observation carried forward)|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||0.17|-0.80|0.201
72349749|NCT00377858|144220516|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.16||||0.43||95.0|-0.57|0.24||P-value for Endpoint: Midday Pre-Meal. (last observation carried forward)|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||0.24|-0.57|0.430
72429160|NCT03249376|144369309|SUPERIORITY||Least Squares Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|0.22|<|0.0001|TWO_SIDED|95.0|-1.37|-0.51|||Mixed Effects Model for Repeated Measure|||||-0.51|-1.37|<0.0001
72429161|NCT03249376|144369310|SUPERIORITY||Least Squares Mean Difference|4.6||||0.005|TWO_SIDED|95.0|1.42|7.69|||ANCOVA|||||7.69|1.42|0.005
72349750|NCT00377858|144220516|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.06||||0.814||95.0|-0.52|0.41||P-value for Endpoint: Midday Postprandial Meal. (last observation carried forward)|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||0.41|-0.52|0.814
72349751|NCT00377858|144220516|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.17||||0.427||95.0|-0.24|0.57||P-value for Endpoint: Evening Pre-Meal. (last observation carried forward)|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||0.57|-0.24|0.427
72349752|NCT00377858|144220516|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.57||||0.009||95.0|-1.0|-0.14||P-value for Endpoint: Evening Postprandial Meal. (last observation carried forward)|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||-0.14|-1.00|0.009
72349753|NCT00377858|144220516|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.12||||0.569||95.0|-0.51|0.28||P-value for Endpoint: 0300 Hours. (last observation carried forward)|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||0.28|-0.51|0.569
72349754|NCT00377858|144220517|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.02||||0.776||95.0|-0.14|0.19||P-value for Baseline MODD.|ANOVA|ANOVA Model: Variable=Treatment + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||0.19|-0.14|0.776
72349755|NCT00377858|144220517|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.27||||0.737||95.0|-6.14|8.68||P-value for Baseline M-Value.|ANOVA|ANOVA Model: Variable=Treatment + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||8.68|-6.14|0.737
72349756|NCT00377858|144220517|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.03||||0.701||95.0|-0.19|0.13||P-value for 12 Week MODD.|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||0.13|-0.19|0.701
72349757|NCT00377858|144220517|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.58||||0.4||95.0|-2.11|5.27||P-value for 12 Week M-Value.|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||5.27|-2.11|0.400
72349758|NCT00377858|144220517|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.09||||0.321||95.0|-0.26|0.09||P-value for 24 Week MODD.|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||0.09|-0.26|0.321
72349759|NCT00377858|144220517|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.52||||0.179||95.0|-1.16|6.21||P-value for 24 Week M-Value.|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||6.21|-1.16|0.179
72349760|NCT00377858|144220517|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.05||||0.573||95.0|-0.22|0.12||P-value for 36 Week MODD.|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||0.12|-0.22|0.573
72349761|NCT00377858|144220517|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.95||||0.629||95.0|-4.79|2.9||P-value for 36 Week M-Value.|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||2.90|-4.79|0.629
72349762|NCT00377858|144220517|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.09||||0.25||95.0|-0.26|0.07||P-value for Endpoint MODD. (last observation carried forward)|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||0.07|-0.26|0.250
72349763|NCT00377858|144220517|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.72||||0.362||95.0|-5.44|1.99||P-value for Endpoint M-Value.|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||1.99|-5.44|0.362
72349764|NCT00377858|144220518|SUPERIORITY_OR_OTHER|||||||0.094||95.0||||P-value for Endpoint Hypoglycemic Episodes.|Fisher Exact|||||||0.094
72349765|NCT00377858|144220518|SUPERIORITY_OR_OTHER|||||||1||95.0||||P-value for Overall Hypoglycemic Episodes.|Fisher Exact|||||||1.00
72349766|NCT00377858|144220518|SUPERIORITY_OR_OTHER|||||||0.43||95.0||||P-value for Endpoint Nocturnal Hypoglycemic Episodes.|Fisher Exact|||||||0.430
72349767|NCT00377858|144220518|SUPERIORITY_OR_OTHER|||||||1||95.0||||P-value for Overall Nocturnal Hypoglycemic Episodes.|Fisher Exact|||||||1.00
72349768|NCT00377858|144220518|SUPERIORITY_OR_OTHER|||||||0.013||95.0||||P-value for Endpoint Non-Nocturnal Hypoglycemic Episodes.|Fisher Exact|||||||0.013
72349769|NCT00377858|144220518|SUPERIORITY_OR_OTHER|||||||0.756||95.0||||P-value for Overall Non-Nocturnal Hypoglycemic Episodes.|Fisher Exact|||||||0.756
72349770|NCT00377858|144220519|SUPERIORITY_OR_OTHER|||||||0.022||95.0||||P-value for Endpoint Hypoglycemic Rate.|ANOVA|ANOVA Model: Rank of Variable = Treatment + Sufonylurea Stratum + Country + Baseline HbA1c Stratum.||||||0.022
72349771|NCT00377858|144220519|SUPERIORITY_OR_OTHER|||||||0.218||95.0||||P-value for Overall Hypoglycemic Rate.|ANOVA|ANOVA Model: Rank of Variable = Treatment + Sufonylurea Stratum + Country + Baseline HbA1c Stratum.||||||0.218
72349772|NCT00377858|144220519|SUPERIORITY_OR_OTHER|||||||0.311||95.0||||P-value for Endpoint Nocturnal Hypoglycemic Rate.|ANOVA|ANOVA Model: Rank of Variable = Treatment + Sufonylurea Stratum + Country + Baseline HbA1c Stratum.||||||0.311
72429162|NCT01009047|144369346|SUPERIORITY_OR_OTHER||Least-squares (LS) mean difference|0.1|STANDARD_ERROR_OF_MEAN|1.83||0.935|TWO_SIDED|95.0|-3.46|3.76||Analysis of covariance (ANCOVA) model with treatment (paliperidone ER, aripiprazole) and country as factors, and baseline value as a covariate was used.|ANCOVA|||||3.76|-3.46|0.935
72349773|NCT00377858|144220519|SUPERIORITY_OR_OTHER|||||||0.615||95.0||||P-value for Overall Nocturnal Hypoglycemic Rate.|ANOVA|ANOVA Model: Rank of Variable = Treatment + Sufonylurea Stratum + Country + Baseline HbA1c Stratum.||||||0.615
72349774|NCT00377858|144220519|SUPERIORITY_OR_OTHER|||||||0.018||95.0||||P-value for Endpoint Non-Nocturnal Hypoglycemic Rate.|ANOVA|ANOVA Model: Rank of Variable = Treatment + Sufonylurea Stratum + Country + Baseline HbA1c Stratum.||||||0.018
72349775|NCT00377858|144220519|SUPERIORITY_OR_OTHER|||||||0.255||95.0||||P-value for Overall Non-Nocturnal Hypoglycemic Rate.|ANOVA|ANOVA Model: Rank of Variable = Treatment + Sufonylurea Stratum + Country + Baseline HbA1c Stratum.||||||0.255
72349776|NCT00377858|144220520|SUPERIORITY_OR_OTHER|||||||0.416||95.0||||P-value for Overall Severe Hypoglycemic Episodes.|Fisher Exact|||||||0.416
72349777|NCT00377858|144220521|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.08|||<|0.001||95.0|-0.12|-0.05||P-value for Daily Basal.|ANCOVA|ANCOVA Model: Variable=Treatment + Country + Baseline HbA1c stratum + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||-0.05|-0.12|<0.001
72349778|NCT00377858|144220521|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.07|||<|0.001||95.0|0.04|0.11||P-value for Daily Prandial.|ANCOVA|ANCOVA Model: Variable=Treatment + Country + Baseline HbA1c stratum + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||0.11|0.04|<0.001
72349779|NCT00377858|144220521|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.07||||0.017||95.0|0.01|0.12||P-value for Daily Total.|ANCOVA|ANCOVA Model: Variable=Treatment + Country + Baseline HbA1c stratum + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||0.12|0.01|0.017
72349780|NCT00377858|144220522|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-6.96|||<|0.001||95.0|-9.65|-4.26||P-value for Daily Basal.|ANCOVA|ANCOVA Model: Variable=Treatment + Country + Baseline HbA1c stratum + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||-4.26|-9.65|<0.001
72349781|NCT00377858|144220522|SUPERIORITY_OR_OTHER||Mean Difference (Net)|6.05|||<|0.001||95.0|3.39|8.71||P-value for Daily Prandial.|ANCOVA|ANCOVA Model: Variable=Treatment + Country + Baseline HbA1c stratum + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||8.71|3.39|<0.001
72349782|NCT00377858|144220522|SUPERIORITY_OR_OTHER||Mean Difference (Net)|5.2||||0.017||95.0|0.93|9.46||P-value for Daily Total.|ANCOVA|ANCOVA Model: Variable=Treatment + Country + Baseline HbA1c stratum + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||9.46|0.93|0.017
72349783|NCT00377858|144220523|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.33|||<|0.001||95.0|0.24|0.42||P-value for Week 12.|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline HbA1c stratum + Sulfonylurea stratum + Country.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||0.42|0.24|<0.001
72349784|NCT00377858|144220523|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.22||||0.003||95.0|0.07|0.36||P-value for Week 24.|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline HbA1c stratum + Sulfonylurea stratum + Country.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||0.36|0.07|0.003
72349785|NCT00377858|144220523|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.24||||0.002||95.0|0.09|0.4||P-value for Week 30.|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||0.40|0.09|0.002
72349786|NCT00377858|144220523|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.22||||0.005||95.0|0.07|0.38||P-value for Week 36.|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline HbA1c stratum + Sulfonylurea stratum + Country.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||0.38|0.07|0.005
72349787|NCT00377858|144220523|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.19||||0.011||95.0|0.04|0.34||P-value for Endpoint. (last observation carried forward)|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline HbA1c stratum + Sulfonylurea stratum + Country.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||0.34|0.04|0.011
72349788|NCT00377858|144220524|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.09||||0.803||95.0|-0.8|0.62||P-value for Change from Baseline.|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline + Sulfonylurea stratum + Country + Baseline HbA1c stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||0.62|-0.80|0.803
72349789|NCT04034004|144220552|SUPERIORITY|||||||0.05|||||||Mixed Models Analysis|||Pain ratings were collected while lying in the supine and after each straight leg rasise test (SLR 1; SLR 2). A 2 (group) X 2 (SLR 1-rest vs. SLR 2-meditation) X 2 (supine vs. SLR) X 3 (session) repeated measure mixed model ANOVA was conducted to determine if mindfulness and non-mindfulness meditation attenuate SLR induced pain through endogenous opioids. Simple effects tests tested significant main effects and interactions to test primary study hypotheses and between-group differences.||||.05
72349790|NCT01345188|144220563|SUPERIORITY_OR_OTHER_LEGACY|||||||0.058|||||||Paired t test|||||||0.058
72349791|NCT01345188|144220564|SUPERIORITY_OR_OTHER_LEGACY|||||||0.048|||||||Paired t test|||||||0.048
72349792|NCT01345188|144220565|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|||||||Wilcoxon Signed rank|||||||>0.05
72349793|NCT01397461|144220583|SUPERIORITY_OR_OTHER|||||||0.003|||||||Chi-squared|||"The treatment comparison was done using only the outcomes of Clinical success and Clinical failure. The p value of the chi square test (without continuity correction) and corresponding 95% asymptotic (Wald) CI for the difference in success rates for the ozenoxacin versus placebo were provided. The analysis was performed to test the superiority of ozenoxacin versus placebo.~Text extracted from the statistical analysis plan. No additional data was pre-specified for the statistical comparison"||||0.003
72349794|NCT05729568|144220589|SUPERIORITY||Difference in least-squares means|-56.0||||0.1436|TWO_SIDED|95.0|-132.0|20.0|||ANCOVA||Difference in least-squares means (Diff in LSM), and its 95% CI were from ANCOVA model of change from baseline CD4 cell count with treatment as fixed effect and baseline CD4 cell count as a covariate.|||20|-132|0.1436
72349795|NCT04181762|144220602|SUPERIORITY||Mean Difference (Final Values)|-12.7||||0.0662|TWO_SIDED|95.0|-26.3|0.9|||Regression, Logistic||Difference from placebo and 95% CI are from a logistic regression model with treatment group, stratification factor (SoC) and race as factors and baseline UPCR as a covariate using marginal standardization method.|Complete Renal Response (CRR) at Week 52||0.9|-26.3|0.0662
72349796|NCT04181762|144220604|OTHER||Mean Difference (Final Values)|-7.7|||||TWO_SIDED|95.0|-23.7|8.4|||||95% Confidence Intervals (CIs) are constructed using the exact binomial test.|Partial Renal Response (PRR) at Week 52||8.4|-23.7|
72349797|NCT05919888|144220669|SUPERIORITY|||||||0.275|||||||Chi-squared|||||||0.275
72349798|NCT05919888|144220670|SUPERIORITY|||||||0.0056|||||||Chi-squared|||||||0.0056
72349799|NCT05919888|144220671|SUPERIORITY|||||||0.286|||||||Chi-squared|||||||0.286
72349800|NCT02204072|144220675|OTHER||Hazard Ratio (HR)|0.98||||0.9549|TWO_SIDED|95.0|0.57|1.7|||Two-sided log-rank test.||Cox proportional hazard model. Hazard ratio: Comparison vs Enzalutamide|||1.70|0.57|0.9549
72349801|NCT02204072|144220678|OTHER||Hazard Ratio (HR)|1.19||||0.5425|TWO_SIDED|95.0|0.68|2.06|||Two-sided log-rank test.||Cox proportional hazards model. Hazard ratio: Comparison vs. Enzaludamide.|||2.06|0.68|0.5425
72349802|NCT02204072|144220679|OTHER||Hazard Ratio (HR)|1.16||||0.5534|TWO_SIDED|95.0|0.71|1.9|||Two-sided log-rank test.||Cox proportional hazards model. Hazard ratio: Comparison vs. Enzalutamide.|||1.90|0.71|0.5534
72349803|NCT02204072|144220680|OTHER||Hazard Ratio (HR)|0.64||||0.1514|TWO_SIDED|95.0|0.35|1.18|||Two-sided log-rank test.||Cox proportional hazards model. Hazard ratio: Comparison vs. Enzalutamide.|||1.18|0.35|0.1514
72349804|NCT02204072|144220684|OTHER||Odds Ratio (OR)|1.579||||0.6186|TWO_SIDED|95.0|0.269|12.515|||Regression, Logistic|Odds ratio, p-value and confidence interval were obtained from logistic regression model.||||12.515|0.269|0.6186
72349805|NCT02204072|144220686|OTHER||Odds Ratio (OR)|1.891||||0.192|TWO_SIDED|95.0|0.727|5.059|||Regression, Logistic||Odds ratio, p-value and confidence interval were obtained from logistic regression model.|||5.059|0.727|0.1920
72349806|NCT00999544|144220694|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||"Area-under-the-curve (AUC) scores were derived from time course data and analyzed using two-factor ANOVA \[aprepitant dose (3 levels)x oxycodone dose (3 levels)\].~All analyses were conducted using SAS 9.1 for Windows (SAS Institute Inc., Cary, NC, USA) and were considered significant when P 0.05."||||<.05
72349807|NCT02309944|144220710|SUPERIORITY|||||||0.27|TWO_SIDED|95.0|||||Chi-squared|||Negative Pressure Wound Therapy vs. Standard Wound Closure||||0.27
72349808|NCT02309944|144220710|SUPERIORITY|||||||0.24|||||||Regression, Logistic|Multivariate Model (adjusted for ascites and previous laparotomy)||Negative Pressure Wound Therapy vs. Standard Wound Closure||||0.24
72349809|NCT01525615|144220733|SUPERIORITY_OR_OTHER||Treatment ratio|1.138|STANDARD_ERROR_OF_MEAN|0.063||0.0209|TWO_SIDED|95.0|1.02|1.269||Mixed effects Model for Repeated Measures (MMRM) with fixed effects of treatment, test day, treatment by test day interaction, log10 (baseline endurance time), log10 (baseline endurance time) by test day interaction, and patient as a random effect.|Mixed Models Analysis|Mean and 95% confidence limits were transformed from log10 back to the original scale. SE was calculated using the delta method.||Treatment ratio between Tio+Olo 5.0/5.0 and placebo. This treatment comparison is the first one in the alpha-protected hierarchical testing chain.||1.269|1.020|0.0209
72349810|NCT01525615|144220733|SUPERIORITY_OR_OTHER||Treatment ratio|1.086|STANDARD_ERROR_OF_MEAN|0.061||0.1419|TWO_SIDED|95.0|0.973|1.213||MMRM model for log10 (endurance time \[s\]) with fixed effects of treatment, test day, treatment by test day interaction, log10 (baseline endurance time \[s\]), log10 (baseline endurance time \[s\]) by test day interaction, patient as a random effect.|Mixed Models Analysis|Mean and 95% confidence limits were transformed from log10 back to the original scale. SE was calculated using the delta method.||Treatment ratio between Tio+Olo 2.5/5.0 and placebo. This treatment comparison is the second one in the alpha-protected hierarchical testing chain. Since the p-value for this treatment comparison is \>0.05, the hierarchical testing chain is broken and all of the following hypothesis tests in this hierarchical chain are considered as descriptive only.||1.213|0.973|0.1419
72349811|NCT01525615|144220733|SUPERIORITY_OR_OTHER||Treatment ratio|1.047|STANDARD_ERROR_OF_MEAN|0.057||0.397|TWO_SIDED|95.0|0.941|1.166||MMRM model for log10 (endurance time \[s\]) with fixed effects of treatment, test day, treatment by test day interaction, log10 (baseline endurance time \[s\]), log10 (baseline endurance time \[s\]) by test day interaction, patient as a random effect.|Mixed Models Analysis|Mean and 95% confidence limits were transformed from log10 back to the original scale. SE was calculated using the delta method.||Treatment ratio between Tio+Olo 5.0/5.0 and Tio+Olo 2.5/5.0. This treatment comparison is not included in the alpha-protected hierarchical testing chain.||1.166|0.941|0.3970
72349812|NCT01525615|144220734|SUPERIORITY_OR_OTHER||Tretament ratio|1.209|STANDARD_ERROR_OF_MEAN|0.119||0.0552|TWO_SIDED|95.0|0.996|1.467||MMRM model for log10 (endurance time \[s\]) with fixed effects of treatment, test day, treatment by test day interaction, log10 (baseline endurance time \[s\]), log10 (baseline endurance time \[s\]) by test day interaction, patient as a random effect.|Mixed Models Analysis|Mean and 95% confidence limits were transformed from log10 back to the original scale. SE was calculated using the delta method.||Treatment ratio between Tio+Olo 5.0/5.0 and placebo. Since the hierarchical testing chain has been broken, even though this treatment comparison is included as the 3rd one in the alpha-protected hierarchical testing chain, this hypothesis test is descriptive only.||1.467|0.996|0.0552
72349813|NCT01525615|144220734|SUPERIORITY_OR_OTHER||Treatment ratio|1.211|STANDARD_ERROR_OF_MEAN|0.121||0.0562|TWO_SIDED|95.0|0.995|1.475||MMRM model for log10 (endurance time \[s\]) with fixed effects of treatment, test day, treatment by test day interaction, log10 (baseline endurance time \[s\]), log10 (baseline endurance time \[s\]) by test day interaction, patient as a random effect.|Mixed Models Analysis|Mean, 95% confidence limits transformed from log10 to original scale. SE was calculated using the delta method. This hypothesis test is descriptive.||Treatment ratio between Tio+Olo 2.5/5.0 and placebo||1.475|0.995|0.0562
72349814|NCT01525615|144220734|SUPERIORITY_OR_OTHER||Treatment ratio|0.998|STANDARD_ERROR_OF_MEAN|0.095||0.9822|TWO_SIDED|95.0|0.826|1.205||MMRM model for log10 (endurance time \[s\]) with fixed effects of treatment, test day, treatment by test day interaction, log10 (baseline endurance time \[s\]), log10 (baseline endurance time \[s\]) by test day interaction, patient as a random effect.|Mixed Models Analysis|Mean and 95% confidence limits were transformed from log10 back to the original scale. SE was calculated using the delta method.||Treatment ratio between Tio+Olo 5.0/5.0 and Tio+Olo 2.5/5.0. This treatment comparison is not included in the alpha-protected hierarchical testing chain.||1.205|0.826|0.9822
72349815|NCT01525615|144220735|SUPERIORITY_OR_OTHER||LSMean Difference-Final Values|0.234|STANDARD_ERROR_OF_MEAN|0.052|<|0.0001|TWO_SIDED|95.0|0.133|0.336||MMRM model for inspiratory capacity with fixed effects of treatment, test day, treatment by test day interaction, baseline inspiratory capacity, baseline inspiratory capacity by test day interaction, and patient as a random effect.|Mixed Models Analysis|This hypothesis test is descriptive.|LSMean=Least square mean.|||0.336|0.133|<0.0001
72349816|NCT01525615|144220735|SUPERIORITY_OR_OTHER||LSMean Difference-Final Values|0.207|STANDARD_ERROR_OF_MEAN|0.052|<|0.0001|TWO_SIDED|95.0|0.105|0.309||MMRM model for inspiratory capacity with fixed effects of treatment, test day, treatment by test day interaction, baseline inspiratory capacity, baseline inspiratory capacity by test day interaction, and patient as a random effect.|Mixed Models Analysis|This hypothesis test is descriptive.||||0.309|0.105|<0.0001
72349817|NCT01525615|144220735|SUPERIORITY_OR_OTHER||LSMean Difference-Final Values|0.027|STANDARD_ERROR_OF_MEAN|0.05||0.5892|TWO_SIDED|95.0|-0.072|0.126||MMRM model for inspiratory capacity with fixed effects of treatment, test day, treatment by test day interaction, baseline inspiratory capacity, baseline inspiratory capacity by test day interaction, and patient as a random effect.|Mixed Models Analysis|This hypothesis test is descriptive.||||0.126|-0.072|0.5892
72349818|NCT01525615|144220736|SUPERIORITY_OR_OTHER||Treatment ratio|1.126|STANDARD_ERROR_OF_MEAN|0.059||0.0245|TWO_SIDED|95.0|1.015|1.248||ANCOVA model for log10 (endurance time \[s\]) with categorical effects of treatment and (log10-transformed) baseline as continuous covariate.|ANCOVA|This hypothesis test is descriptive.||Treatment ratio between Tio+Olo 5.0/5.0 and placebo||1.248|1.015|0.0245
72349819|NCT01525615|144220736|SUPERIORITY_OR_OTHER||Treatment ratio|1.103|STANDARD_ERROR_OF_MEAN|0.058||0.0655|TWO_SIDED|95.0|0.994|1.223|||ANCOVA|Descriptive||Treatment ratio between Tio+Olo 2.5/5.0 and placebo||1.223|0.994|0.0655
72349820|NCT01525615|144220736|SUPERIORITY_OR_OTHER||Treatment ratio|1.021|STANDARD_ERROR_OF_MEAN|0.053||0.6912|TWO_SIDED|95.0|0.921|1.132|||ANCOVA|Descriptive||Treatment ratio between Tio+Olo 5.0/5.0 and Tio+Olo 2.5/5.0||1.132|0.921|0.6912
72349821|NCT01525615|144220737|SUPERIORITY_OR_OTHER||Treatment ratio|1.229|STANDARD_ERROR_OF_MEAN|0.068||0.0002|TWO_SIDED|95.0|1.103|1.37||MMRM model for log10 (endurance time \[s\]) with fixed effects of treatment, test day, treatment by test day interaction, log10 (baseline endurance time \[s\]), log10 (baseline endurance time \[s\]) by test day interaction, patient as a random effect.|Mixed Models Analysis|Mean and 95% confidence limits were transformed from log10 back to the original scale. SE was calculated using the delta method.||Treatment ratio between Tio+Olo 5.0/5.0 and placebo. Hypothesis test is descriptive||1.370|1.103|0.0002
72349822|NCT01525615|144220737|SUPERIORITY_OR_OTHER||Treatment ratio|1.221|STANDARD_ERROR_OF_MEAN|0.068||0.0004|TWO_SIDED|95.0|1.095|1.362||MMRM model for log10 (endurance time \[s\]) with fixed effects of treatment, test day, treatment by test day interaction, log10 (baseline endurance time \[s\]), log10 (baseline endurance time \[s\]) by test day interaction, patient as a random effect.|Mixed Models Analysis|Mean and 95% confidence limits were transformed from log10 back to the original scale. SE was calculated using the delta method.||Treatment ratio between Tio+Olo 2.5/5.0 and placebo. Hypothesis test is descriptive.||1.362|1.095|0.0004
72349823|NCT01525615|144220737|SUPERIORITY_OR_OTHER||Treatment ratio|1.006|STANDARD_ERROR_OF_MEAN|0.055||0.9062|TWO_SIDED|95.0|0.905|1.12||MMRM model for log10 (endurance time \[s\]) with fixed effects of treatment, test day, treatment by test day interaction, log10 (baseline endurance time \[s\]), log10 (baseline endurance time \[s\]) by test day interaction, patient as a random effect.|Mixed Models Analysis|Mean and 95% confidence limits were transformed from log10 back to the original scale. SE was calculated using the delta method.||Treatment ratio between Tio+Olo 5.0/5.0 and Tio+Olo 2.5/5.0. Hypothesis test is descriptive.||1.12|0.905|0.9062
72349824|NCT01525615|144220738|SUPERIORITY_OR_OTHER||LSMean Difference-Final Values|0.165|STANDARD_ERROR_OF_MEAN|0.058||0.0049|TWO_SIDED|95.0|0.051|0.279||ANCOVA model for inspiratory capacity (liters) with categorical effect of treatment and baseline as continuous covariate.|ANCOVA|Descriptive||||0.279|0.051|0.0049
72349825|NCT01525615|144220738|SUPERIORITY_OR_OTHER||LSMean Difference-Final Values|0.202|STANDARD_ERROR_OF_MEAN|0.058||0.0006|TWO_SIDED|95.0|0.088|0.316||ANCOVA model for inspiratory capacity (liters) with categorical effect of treatment and baseline as continuous covariate.|ANCOVA|Descriptive||||0.316|0.088|0.0006
72349826|NCT01525615|144220738|SUPERIORITY_OR_OTHER||LSMean Difference-Final Values|-0.037|STANDARD_ERROR_OF_MEAN|0.058||0.5162|TWO_SIDED|95.0|-0.151|0.076||ANCOVA model for inspiratory capacity (liters) with categorical effect of treatment and baseline as continuous covariate.|ANCOVA|Descriptive||||0.076|-0.151|0.5162
72349827|NCT01525615|144220739|SUPERIORITY_OR_OTHER||LSMean Difference-Final Values|0.225|STANDARD_ERROR_OF_MEAN|0.051|<|0.0001|TWO_SIDED|95.0|0.124|0.326||MMRM model for inspiratory capacity with fixed effects of treatment, test day, treatment by test day interaction, baseline inspiratory capacity, baseline inspiratory capacity by test day interaction, and patient as a random effect.|Mixed Models Analysis|Descriptive||||0.326|0.124|<0.0001
72349828|NCT01525615|144220739|SUPERIORITY_OR_OTHER||LSMean Difference-Final Values|0.187|STANDARD_ERROR_OF_MEAN|0.052||0.0003|TWO_SIDED|95.0|0.086|0.288||MMRM model for inspiratory capacity with fixed effects of treatment, test day, treatment by test day interaction, baseline inspiratory capacity, baseline inspiratory capacity by test day interaction, and patient as a random effect.|Mixed Models Analysis|Descriptive||||0.288|0.086|0.0003
72349829|NCT01525615|144220739|SUPERIORITY_OR_OTHER||LSMean Difference-Final Values|0.038|STANDARD_ERROR_OF_MEAN|0.05||0.4541|TWO_SIDED|95.0|-0.061|0.137||MMRM model for inspiratory capacity with fixed effects of treatment, test day, treatment by test day interaction, baseline inspiratory capacity, baseline inspiratory capacity by test day interaction, and patient as a random effect.|Mixed Models Analysis|Descriptive||||0.137|-0.061|0.4541
72349830|NCT01525615|144220740|SUPERIORITY_OR_OTHER||LSMean Difference-Final Values|-0.002|STANDARD_ERROR_OF_MEAN|0.001||0.0468|TWO_SIDED|95.0|-0.004|0.0||ANCOVA model for mean slope of the intensity of breathing discomfort with categorical effect of treatment and baseline as continuous covariate.|ANCOVA|Descriptive||||-0.000|-0.004|0.0468
72349831|NCT01525615|144220740|SUPERIORITY_OR_OTHER||LSMean Difference-Final Values|-0.002|STANDARD_ERROR_OF_MEAN|0.001||0.018|TWO_SIDED|95.0|-0.005|0.0||ANCOVA model for mean slope of the intensity of breathing discomfort with categorical effect of treatment and baseline as continuous covariate.|ANCOVA|Descriptive||||-0.000|-0.005|0.0180
72349832|NCT01525615|144220740|SUPERIORITY_OR_OTHER||LSMean Difference-Final Values|0.0|STANDARD_ERROR_OF_MEAN|0.001||0.6856|TWO_SIDED|95.0|-0.002|0.002||ANCOVA model for mean slope of the intensity of breathing discomfort with categorical effect of treatment and baseline as continuous covariate.|ANCOVA|Descriptive||||0.002|-0.002|0.6856
72349833|NCT01525615|144220741|SUPERIORITY_OR_OTHER||LSMean Difference-Final Values|-0.003|STANDARD_ERROR_OF_MEAN|0.001||0.0081|TWO_SIDED|95.0|-0.005|-0.001||MMRM model with fixed effects of treatment, test day, treatment by test day interaction, baseline, baseline by test day interaction, and patient as a random effect.|Mixed Models Analysis|Descriptive||||-0.001|-0.005|0.0081
72349834|NCT01525615|144220741|SUPERIORITY_OR_OTHER||LSMean Difference-Final Values|-0.003|STANDARD_ERROR_OF_MEAN|0.001||0.0099|TWO_SIDED|95.0|-0.005|-0.001||MMRM model with fixed effects of treatment, test day, treatment by test day interaction, baseline, baseline by test day interaction, and patient as a random effect.|Mixed Models Analysis|Descriptive||||-0.001|-0.005|0.0099
72349835|NCT01525615|144220741|SUPERIORITY_OR_OTHER||LSMean Difference-Final Values|0.0|STANDARD_ERROR_OF_MEAN|0.001||0.9626|TWO_SIDED|95.0|-0.002|0.002||MMRM model with fixed effects of treatment, test day, treatment by test day interaction, baseline, baseline by test day interaction, and patient as a random effect.|Mixed Models Analysis|Descriptive||||0.002|-0.002|0.9626
72429163|NCT01009047|144369347|SUPERIORITY_OR_OTHER||LS mean difference|-0.3|STANDARD_ERROR_OF_MEAN|2.2||0.877|TWO_SIDED|95.0|-4.68|4.0||Analysis of covariance (ANCOVA) model with treatment groups (paliperidone ER, aripiprazole) and country as factors, and baseline value as a covariate was used.|ANCOVA|||||4.00|-4.68|0.877
72429164|NCT01009047|144369348|SUPERIORITY_OR_OTHER||LS mean difference|0.5|STANDARD_ERROR_OF_MEAN|0.54||0.341|TWO_SIDED|95.0|-0.55|1.59||Day 56: Analysis of covariance (ANCOVA) model with treatment (paliperidone ER, aripiprazole) and country as factors, and baseline value as a covariate was used.|ANCOVA|||||1.59|-0.55|0.341
72349836|NCT01525615|144220742|SUPERIORITY_OR_OTHER||LSMean Difference-Final Values|-0.002|STANDARD_ERROR_OF_MEAN|0.001||0.0598|TWO_SIDED|95.0|-0.004|0.0||MMRM model with fixed effects of treatment, test day, treatment by test day interaction, baseline, baseline by test day interaction, and patient as a random effect.|Mixed Models Analysis|Descriptive||||0.000|-0.004|0.0598
72349837|NCT01525615|144220742|SUPERIORITY_OR_OTHER||LSMean Difference-Final Values|-0.003|STANDARD_ERROR_OF_MEAN|0.001||0.0218|TWO_SIDED|95.0|-0.005|0.0||MMRM model with fixed effects of treatment, test day, treatment by test day interaction, baseline, baseline by test day interaction, and patient as a random effect.|Mixed Models Analysis|Descriptive||||-0.000|-0.005|0.0218
72349838|NCT01525615|144220742|SUPERIORITY_OR_OTHER||LSMean Difference-Final Values|0.0|STANDARD_ERROR_OF_MEAN|0.001||0.6549|TWO_SIDED|95.0|-0.002|0.003||MMRM model with fixed effects of treatment, test day, treatment by test day interaction, baseline, baseline by test day interaction, and patient as a random effect.|Mixed Models Analysis|Descriptive||||0.003|-0.002|0.6549
72349839|NCT01525615|144220743|SUPERIORITY_OR_OTHER||LSMean Difference-Final Values|0.17|STANDARD_ERROR_OF_MEAN|0.028|<|0.0001|TWO_SIDED|95.0|0.116|0.224||MMRM model with fixed effects of treatment, test day, treatment by test day interaction, baseline, baseline by test day interaction, and patient as a random effect.|Mixed Models Analysis|Descriptive||||0.224|0.116|<0.0001
72349840|NCT01525615|144220743|SUPERIORITY_OR_OTHER||LSMean Difference-Final Values|0.184|STANDARD_ERROR_OF_MEAN|0.028|<|0.0001|TWO_SIDED|95.0|0.129|0.239||MMRM model with fixed effects of treatment, test day, treatment by test day interaction, baseline, baseline by test day interaction, and patient as a random effect.|Mixed Models Analysis|Descriptive||||0.239|0.129|<0.0001
72349841|NCT01525615|144220743|SUPERIORITY_OR_OTHER||LSMean Difference-Final Values|-0.014|STANDARD_ERROR_OF_MEAN|0.027||0.6105|TWO_SIDED|95.0|-0.067|0.04||MMRM model with fixed effects of treatment, test day, treatment by test day interaction, baseline, baseline by test day interaction, and patient as a random effect.|Mixed Models Analysis|Descriptive||||0.040|-0.067|0.6105
72349842|NCT01525615|144220744|SUPERIORITY_OR_OTHER||LSMean Difference-Final Values|0.246|STANDARD_ERROR_OF_MEAN|0.028|<|0.0001|TWO_SIDED|95.0|0.192|0.3||MMRM model with fixed effects of treatment, test day, treatment by test day interaction, baseline, baseline by test day interaction, and patient as a random effect.|Mixed Models Analysis|Descriptive||||0.300|0.192|<0.0001
72349843|NCT01525615|144220744|SUPERIORITY_OR_OTHER||LSMean Difference-Final Values|0.273|STANDARD_ERROR_OF_MEAN|0.028|<|0.0001|TWO_SIDED|95.0|0.218|0.328||MMRM model with fixed effects of treatment, test day, treatment by test day interaction, baseline, baseline by test day interaction, and patient as a random effect.|Mixed Models Analysis|Descriptive||||0.328|0.218|<0.0001
72349844|NCT01525615|144220744|SUPERIORITY_OR_OTHER||LSMean Difference-Final Values|-0.027|STANDARD_ERROR_OF_MEAN|0.027||0.3236|TWO_SIDED|95.0|-0.08|0.027||MMRM model with fixed effects of treatment, test day, treatment by test day interaction, baseline, baseline by test day interaction, and patient as a random effect.|Mixed Models Analysis|Descriptive||||0.027|-0.080|0.3236
72349845|NCT01525615|144220745|SUPERIORITY_OR_OTHER||LSMean Difference-Final Values|0.251|STANDARD_ERROR_OF_MEAN|0.028|<|0.0001|TWO_SIDED|95.0|0.196|0.305||MMRM model with fixed effects of treatment, test day, treatment by test day interaction, baseline, baseline by test day interaction, and patient as a random effect.|Mixed Models Analysis|Descriptive||||0.305|0.196|<0.0001
72349846|NCT01525615|144220745|SUPERIORITY_OR_OTHER||LSMean Difference-Final Values|0.257|STANDARD_ERROR_OF_MEAN|0.028|<|0.0001|TWO_SIDED|95.0|0.202|0.312||MMRM model with fixed effects of treatment, test day, treatment by test day interaction, baseline, baseline by test day interaction, and patient as a random effect.|Mixed Models Analysis|Descriptive||||0.312|0.202|<0.0001
72349847|NCT01525615|144220745|SUPERIORITY_OR_OTHER||LSMean Difference-Final Values|-0.006|STANDARD_ERROR_OF_MEAN|0.027||0.8156|TWO_SIDED|95.0|-0.06|0.047||MMRM model with fixed effects of treatment, test day, treatment by test day interaction, baseline, baseline by test day interaction, and patient as a random effect.|Mixed Models Analysis|Descriptive||||0.047|-0.060|0.8156
72349848|NCT03777059|144220801|SUPERIORITY||Least Squares Mean Difference|-1.21|STANDARD_ERROR_OF_MEAN|0.291|<|0.0001|TWO_SIDED|95.0|-1.78|-0.64||MMRM model included Baseline monthly migraine days as a covariate, treatment group and visit (month) as fixed factors, and treatment group-by-visit and Baseline-by-visit as interaction terms, with an unstructured covariance matrix.|Mixed-effects Model for Repeated Measure|||||-0.64|-1.78|<.0001
72349849|NCT03777059|144220801|SUPERIORITY||Least Squares Mean Difference|-1.38|STANDARD_ERROR_OF_MEAN|0.287|<|0.0001|TWO_SIDED|95.0|-1.94|-0.82||MMRM model included Baseline monthly migraine days as a covariate, treatment group and visit (month) as fixed factors, and treatment group-by-visit and Baseline-by-visit as interaction terms, with an unstructured covariance matrix.|Mixed-effects Model for Repeated Measure|||||-0.82|-1.94|<.0001
72349850|NCT03777059|144220801|SUPERIORITY||Least Squares Mean Difference|-1.72|STANDARD_ERROR_OF_MEAN|0.288|<|0.0001|TWO_SIDED|95.0|-2.28|-1.15||MMRM model included Baseline monthly migraine days as a covariate, treatment group and visit (month) as fixed factors, and treatment group-by-visit and Baseline-by-visit as interaction terms, with an unstructured covariance matrix.|Mixed-effects Model for Repeated Measure|||||-1.15|-2.28|<.0001
72349851|NCT03777059|144220802|SUPERIORITY||Least Squares Mean Difference|-1.42|STANDARD_ERROR_OF_MEAN|0.311|<|0.0001|TWO_SIDED|95.0|-2.03|-0.81||MMRM model included Baseline monthly migraine days as a covariate, treatment group and visit (month) as fixed factors, and treatment group-by-visit and Baseline-by-visit as interaction terms, with an unstructured covariance matrix.|Mixed-effects Model for Repeated Measure|||||-0.81|-2.03|<.0001
72349852|NCT03777059|144220802|SUPERIORITY||Least Squares Mean Difference|-1.53|STANDARD_ERROR_OF_MEAN|0.307|<|0.0001|TWO_SIDED|95.0|-2.13|-0.92||MMRM model included Baseline monthly migraine days as a covariate, treatment group and visit (month) as fixed factors, and treatment group-by-visit and Baseline-by-visit as interaction terms, with an unstructured covariance matrix.|Mixed-effects Model for Repeated Measure|||||-0.92|-2.13|<.0001
72349853|NCT03777059|144220802|SUPERIORITY||Least Squares Mean Difference|-1.71|STANDARD_ERROR_OF_MEAN|0.309|<|0.0001|TWO_SIDED|95.0|-2.32|-1.1||MMRM model included Baseline monthly migraine days as a covariate, treatment group and visit (month) as fixed factors, and treatment group-by-visit and Baseline-by-visit as interaction terms, with an unstructured covariance matrix.|Mixed-effects Model for Repeated Measure|||||-1.10|-2.32|<.0001
72429165|NCT01009047|144369348|SUPERIORITY_OR_OTHER||LS mean difference|0.2|STANDARD_ERROR_OF_MEAN|0.66||0.723|TWO_SIDED|95.0|-1.06|1.53||Day 182: Analysis of covariance (ANCOVA) model with treatment (paliperidone ER, aripiprazole) and country as factors, and baseline value as a covariate was used.|ANCOVA|||||1.53|-1.06|0.723
72349854|NCT03777059|144220803|SUPERIORITY||Least Squares Mean Difference|-1.31|STANDARD_ERROR_OF_MEAN|0.254|<|0.0001|TWO_SIDED|95.0|-1.81|-0.82||MMRM model included Baseline monthly migraine days as a covariate, treatment group and visit (month) as fixed factors, and treatment group-by-visit and Baseline-by-visit as interaction terms, with an unstructured covariance matrix.|Mixed-effects Model for Repeated Measure|||||-0.82|-1.81|<.0001
72349855|NCT03777059|144220803|SUPERIORITY||Least Squares Mean Difference|-1.33|STANDARD_ERROR_OF_MEAN|0.251|<|0.0001|TWO_SIDED|95.0|-1.82|-0.83||MMRM model included Baseline monthly migraine days as a covariate, treatment group and visit (month) as fixed factors, and treatment group-by-visit and Baseline-by-visit as interaction terms, with an unstructured covariance matrix.|Mixed-effects Model for Repeated Measure|||||-0.83|-1.82|<.0001
72349856|NCT03777059|144220803|SUPERIORITY||Least Squares Mean Difference|-1.5|STANDARD_ERROR_OF_MEAN|0.252|<|0.0001|TWO_SIDED|95.0|-2.0|-1.01||MMRM model included Baseline monthly migraine days as a covariate, treatment group and visit (month) as fixed factors, and treatment group-by-visit and Baseline-by-visit as interaction terms, with an unstructured covariance matrix.|Mixed-effects Model for Repeated Measure|||||-1.01|-2.00|<.0001
72349857|NCT03777059|144220804|SUPERIORITY||Odds Ratio (OR)|3.06|||<|0.0001|TWO_SIDED|95.0|2.05|4.56||Odds ratio and p-value was based on logistic regression with treatment group, Baseline value, and prior exposure to a migraine prevention medications with proven efficacy as explanatory variables.|Regression, Logistic|||||4.56|2.05|<.0001
72349858|NCT03777059|144220804|SUPERIORITY||Odds Ratio (OR)|3.53|||<|0.0001|TWO_SIDED|95.0|2.37|5.26||Odds ratio and p-value was based on logistic regression with treatment group, Baseline value, and prior exposure to a migraine prevention medications with proven efficacy as explanatory variables.|Regression, Logistic|||||5.26|2.37|<.0001
72349859|NCT03777059|144220804|SUPERIORITY||Odds Ratio (OR)|3.82|||<|0.0001|TWO_SIDED|95.0|2.56|5.71||Odds ratio and p-value was based on logistic regression with treatment group, Baseline value, and prior exposure to a migraine prevention medications with proven efficacy as explanatory variables.|Regression, Logistic|||||5.71|2.56|<.0001
72349860|NCT03777059|144220805|SUPERIORITY||Least Squares Mean Difference|9.9|STANDARD_ERROR_OF_MEAN|2.27|<|0.0001|TWO_SIDED|95.0|5.45|14.36||MMRM model included Baseline monthly migraine days as a covariate, treatment group and visit (month) as fixed factors, and treatment group-by-visit and Baseline-by-visit as interaction terms, with an unstructured covariance matrix.|Mixed-effects Model for Repeated Measure|||||14.36|5.45|<.0001
72349861|NCT03777059|144220805|SUPERIORITY||Least Squares Mean Difference|10.08|STANDARD_ERROR_OF_MEAN|2.229|<|0.0001|TWO_SIDED|95.0|5.71|14.46||MMRM model included Baseline monthly migraine days as a covariate, treatment group and visit (month) as fixed factors, and treatment group-by-visit and Baseline-by-visit as interaction terms, with an unstructured covariance matrix.|Mixed-effects Model for Repeated Measure|||||14.46|5.71|<.0001
72349862|NCT03777059|144220805|SUPERIORITY||Least Squares Mean Difference|10.8|STANDARD_ERROR_OF_MEAN|2.231|<|0.0001|TWO_SIDED|95.0|6.42|15.18||MMRM model included Baseline monthly migraine days as a covariate, treatment group and visit (month) as fixed factors, and treatment group-by-visit and Baseline-by-visit as interaction terms, with an unstructured covariance matrix.|Mixed-effects Model for Repeated Measure|||||15.18|6.42|<.0001
72349863|NCT03777059|144220806|SUPERIORITY||Least Squares Mean Difference|-1.19|STANDARD_ERROR_OF_MEAN|0.693||0.0856|TWO_SIDED|95.0|-2.56|0.17||MMRM model included Baseline monthly migraine days as a covariate, treatment group and visit (month) as fixed factors, and treatment group-by-visit and Baseline-by-visit as interaction terms, with an unstructured covariance matrix.|Mixed-effects Model for Repeated Measure|||||0.17|-2.56|0.0856
72349864|NCT03777059|144220806|SUPERIORITY||Least Squares Mean Difference|-2.54|STANDARD_ERROR_OF_MEAN|0.694||0.0003|TWO_SIDED|95.0|-3.91|-1.18||MMRM model included Baseline monthly migraine days as a covariate, treatment group and visit (month) as fixed factors, and treatment group-by-visit and Baseline-by-visit as interaction terms, with an unstructured covariance matrix.|Mixed-effects Model for Repeated Measure|||||-1.18|-3.91|0.0003
72349865|NCT03777059|144220806|SUPERIORITY||Least Squares Mean Difference|-3.32|STANDARD_ERROR_OF_MEAN|0.694|<|0.0001|TWO_SIDED|95.0|-4.68|-1.96||MMRM model included Baseline monthly migraine days as a covariate, treatment group and visit (month) as fixed factors, and treatment group-by-visit and Baseline-by-visit as interaction terms, with an unstructured covariance matrix.|Mixed-effects Model for Repeated Measure|||||-1.96|-4.68|<.0001
72349866|NCT03777059|144220807|SUPERIORITY||Least Squares Mean Difference|-1.08|STANDARD_ERROR_OF_MEAN|0.605||0.0743|TWO_SIDED|95.0|-2.27|0.11||MMRM model included Baseline monthly migraine days as a covariate, treatment group and visit (month) as fixed factors, and treatment group-by-visit and Baseline-by-visit as interaction terms, with an unstructured covariance matrix.|Mixed-effects Model for Repeated Measure|||||0.11|-2.27|0.0743
72349867|NCT03777059|144220807|SUPERIORITY||Least Squares Mean Difference|-1.99|STANDARD_ERROR_OF_MEAN|0.606||0.0011|TWO_SIDED|95.0|-3.18|-0.8||MMRM model included Baseline monthly migraine days as a covariate, treatment group and visit (month) as fixed factors, and treatment group-by-visit and Baseline-by-visit as interaction terms, with an unstructured covariance matrix.|Mixed-effects Model for Repeated Measure|||||-0.80|-3.18|0.0011
72349868|NCT03777059|144220807|SUPERIORITY||Least Squares Mean Difference|-2.46|STANDARD_ERROR_OF_MEAN|0.605|<|0.0001|TWO_SIDED|95.0|-3.65|-1.28||MMRM model included Baseline monthly migraine days as a covariate, treatment group and visit (month) as fixed factors, and treatment group-by-visit and Baseline-by-visit as interaction terms, with an unstructured covariance matrix.|Mixed-effects Model for Repeated Measure|||||-1.28|-3.65|<.0001
72349869|NCT02451943|144220823|SUPERIORITY||Hazard Ratio (HR)|1.047||||0.6945|TWO_SIDED|95.0|0.841|1.303|||Log Rank|Stratified||||1.303|0.841|0.6945
72349870|NCT02451943|144220824|SUPERIORITY||Hazard Ratio (HR)|0.951||||0.7618|TWO_SIDED|95.0|0.69|1.312|||Log Rank|Stratified||||1.312|0.690|0.7618
72349871|NCT02451943|144220825|SUPERIORITY||Hazard Ratio (HR)|1.231||||0.0422|TWO_SIDED|95.0|1.009|1.502|||Log Rank|Stratified||||1.502|1.009|0.0422
72429166|NCT01009047|144369349|SUPERIORITY_OR_OTHER|||||||0.351||||||Change at Day 56: Positive Symptoms - ANCOVA model with treatment groups (paliperidone ER, aripiprazole) and country as factors, and baseline value as a covariate.|ANCOVA|||||||0.351
72429167|NCT01009047|144369349|SUPERIORITY_OR_OTHER|||||||0.691||||||Change at Day 182:Positive Symptoms - ANCOVA model with treatment groups (paliperidone ER, aripiprazole) and country as factors, and baseline value as a covariate was used.|ANCOVA|||||||0.691
72349872|NCT02451943|144220831|SUPERIORITY||Hazard Ratio (HR)|0.616||||0.0934|TWO_SIDED|95.0|0.347|1.093|||Log Rank|Stratified||||1.093|0.347|0.0934
72349873|NCT02451943|144220832|SUPERIORITY||Hazard Ratio (HR)|1.123||||0.3347|TWO_SIDED|95.0|0.892|1.413|||Log Rank|Stratified||||1.413|0.892|0.3347
72349874|NCT01101035|144220838|NON_INFERIORITY|Noninferiority was declared if the upper 1-sided CI for the hazard ratio was less than 1.3. Critical boundary of 2.359 (75% interim) based on the Lan-DeMets-O'Brien-Fleming alpha spending function was used for CI estimation.|Cox Proportional Hazard|0.99|||||ONE_SIDED|97.0||1.23|||||Time from randomization to the first occurrence of any MACE was fitted using Cox Proportional Hazard model with treatment as a covariate and Baseline renal function as a stratification factor.|Statistical analysis for the primary endpoint was based on 1-sided repeated confidence intervals (CIs), using critical values from a 1-sided stopping boundary for a group sequential design (GSD), to preserve an overall false-rejection rate of 2.5%, to assess non-inferiority at each interim analysis and the final analysis.||1.23||
72349875|NCT01101035|144220839|OTHER||Cox Proportional Hazard|1.09|||||TWO_SIDED|95.0|0.92|1.28|||||Time from randomization to the first occurrence of any APTC event was fitted using Cox Proportional Hazard model with treatment as a covariate and Baseline renal function status as a stratification factor.|||1.28|0.92|
72349876|NCT01101035|144220840|OTHER||Cox Proportional Hazard|1.34|||||TWO_SIDED|95.0|1.03|1.73|||||Time from randomization to the first occurrence of cardiovascular death was fitted using Cox Proportional Hazard model with factors including treatment and baseline renal function.|||1.73|1.03|
72349877|NCT01101035|144220841|OTHER||Cox Proportional Hazard|0.93|||||TWO_SIDED|95.0|0.72|1.21|||||Time from randomization to the first occurrence of non-fatal MI was fitted using Cox Proportional Hazard model with factors including treatment and baseline renal function.|||1.21|0.72|
72349878|NCT01101035|144220842|OTHER||Cox Proportional Hazard|1.01|||||TWO_SIDED|95.0|0.73|1.41|||||Time from randomization to the first occurrence of non-fatal stroke was fitted using Cox Proportional Hazard model with factors including treatment and baseline renal function.|||1.41|0.73|
72349879|NCT01101035|144220843|OTHER||Cox Proportional Hazard|0.86|||||TWO_SIDED|95.0|0.59|1.26|||||Time from randomization to the first occurrence of unstable angina with urgent coronary revascularization was fitted using Cox Proportional Hazard model with factors including treatment and baseline renal function.|||1.26|0.59|
72349880|NCT01101035|144220844|NON_INFERIORITY|Noninferiority was declared if the upper 1-sided CI for the hazard ratio was less than 1.3. Critical boundary of 2.014 (final analysis) based on the Lan-DeMets-O'Brien-Fleming alpha spending function was used for CI estimation.|Cox Proportional Hazard|1.03|||||TWO_SIDED|97.0|0.87|1.23|||||Time from randomization to the first occurrence of any MACE was fitted using Cox Proportional Hazard model with treatment as a covariate and Baseline renal function as a stratification factor.|Statistical analysis for the primary endpoint was based on 1-sided repeated confidence intervals (CIs), using critical values from a 1-sided stopping boundary for a group sequential design (GSD), to preserve an overall false-rejection rate of 2.5%, to assess non-inferiority at each interim analysis and the final analysis.||1.23|0.87|
72349881|NCT00555880|144220847|SUPERIORITY_OR_OTHER_LEGACY||Sign Statistic|3.0||||0.146|TWO_SIDED||||||Sign test||Sign test was performed per analysis plan.|||||0.1460
72349882|NCT00555880|144220848|SUPERIORITY_OR_OTHER_LEGACY||Sign statistic|2.5||||0.2266|TWO_SIDED||||||Sign test||Sign test was performed per analysis plan.|||||0.2266
72349883|NCT00555880|144220849|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|97.9||||0.0418|TWO_SIDED|||||The P-value is based on type III sum of squares for treatment group from a mixed effect ANOVA model with sequence, period and treatment as fixed effects, and subject within sequence as a random effect|ANOVA||Least squares mean for treatment difference (Midodrine HCL-Placebo)|Analysis of treatment difference||||0.0418
72349884|NCT00555880|144220850|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|91.1||||0.1928|TWO_SIDED|||||The P-value is based on type III sum of squares for treatment group from a one-way ANOVA model|ANOVA||Least squares mean for treatment difference (Midodrine HCL-Placebo)|||||0.1928
72349885|NCT00555880|144220851|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9479|TWO_SIDED|||||The P-value is from a 2-sample t-test for difference in mean|t-test, 2 sided|||||||0.9479
72349886|NCT00555880|144220852|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|-5.7||||0.059|TWO_SIDED|||||The P-value is based on type III sum of squares for treatment group from a mixed effect ANOVA model with sequence, period, and treatment as fixed effects and subject within sequence as a random effect.|ANOVA||Least squares mean for treatment difference (Midodrine HCl - Placebo)|Analysis of treatment||||0.0590
72429168|NCT01009047|144369349|SUPERIORITY_OR_OTHER|||||||0.965||||||Change at Day 56: Disorganized thoughts - ANCOVA model with treatment groups (paliperidone ER, aripiprazole) and country as factors, and baseline value as a covariate was used.|ANCOVA|||||||0.965
72349887|NCT00555880|144220853|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0633|TWO_SIDED|||||The P-value is based on type III sum of squares for treatment group from a mixed effect ANOVA model with sequence, period, and treatment as fixed effects and subject within sequence as a random effect.|ANOVA|||Item Dizziness, Lightheadedness, and Feeling Faint-Analysis of treatment||||0.0633
72349888|NCT00555880|144220853|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0191|TWO_SIDED|||||The P-value is based on type III sum of squares for treatment group from a mixed effect ANOVA model with sequence, period, and treatment as fixed effects and subject within sequence as a random effect.|ANOVA|||Item Problems with Vision-Analysis of treatment||||0.0191
72349889|NCT00555880|144220853|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0727|TWO_SIDED|||||The P-value is based on type III sum of squares for treatment group from a mixed effect ANOVA model with sequence, period, and treatment as fixed effects and subject within sequence as a random effect.|ANOVA|||Item Weakness-Analysis of treatment||||0.0727
72349890|NCT00555880|144220853|SUPERIORITY_OR_OTHER_LEGACY|||||||0.282|TWO_SIDED|||||The P-value is based on type III sum of squares for treatment group from a mixed effect ANOVA model with sequence, period, and treatment as fixed effects and subject within sequence as a random effect.|ANOVA|||Item Fatigue-Analysis of treatment||||0.2820
72349891|NCT00555880|144220853|SUPERIORITY_OR_OTHER_LEGACY|||||||0.088|TWO_SIDED|||||The P-value is based on type III sum of squares for treatment group from a mixed effect ANOVA model with sequence, period, and treatment as fixed effects and subject within sequence as a random effect.|ANOVA|||Item Trouble Concentrating-Analysis of treatment||||0.0880
72349892|NCT00555880|144220853|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6439|TWO_SIDED|||||The P-value is based on type III sum of squares for treatment group from a mixed effect ANOVA model with sequence, period, and treatment as fixed effects and subject within sequence as a random effect.|ANOVA|||Item Head/Neck Discomfort-Analysis of treatment||||0.6439
72349893|NCT00555880|144220856|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0378|TWO_SIDED|||||The P-value is based on type III sum of squares for treatment group from a mixed effect ANOVA model with sequence, period, and treatment as fixed effects and subject within sequence as a random effect.|ANOVA|||Final systolic pressure-Analysis of treatment||||0.0378
72349894|NCT00555880|144220856|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0108|TWO_SIDED||||||ANOVA|||Final diastolic pressure-Analysis of treatment||||0.0108
72349895|NCT00555880|144220858|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|92.4||||0.0296|TWO_SIDED|||||The P-value is based on type III sum of squares for treatment group from a mixed effect ANOVA model with sequence, period, and treatment as fixed effects and subject within sequence as a random effect.|ANOVA||Least squares mean for treatment difference (Midodrine HCl - Placebo)|Analysis of treatment difference||||0.0296
72349896|NCT00555880|144220863|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0342|TWO_SIDED||||||Signed Rank Test|||Analysis of treatment||||0.0342
72349897|NCT01173601|144220891|SUPERIORITY_OR_OTHER|||||||0.338||||||In order to test the primary outcome between each LY2216684 dose and placebo while controlling the overall Type I error at 0.05, the significance level was a priori partitioned equally between the 2 LY2216684 dose-placebo comparisons at 0.025.|Mixed Models Analysis|||||||0.338
72349898|NCT01173601|144220891|SUPERIORITY_OR_OTHER|||||||0.201||||||In order to test the primary outcome between each LY2216684 dose and placebo while controlling the overall Type I error at 0.05, the significance level was a priori partitioned equally between the 2 LY2216684 dose-placebo comparisons at 0.025.|Mixed Models Analysis|||||||0.201
72349899|NCT03951077|144220912|SUPERIORITY||Adjusted Response Rate Difference|-5.9||||0.3|TWO_SIDED|90.0|-15.38|3.49|||Cochran-Mantel-Haenszel|||Across the strata, 90% confidence interval (CI) for adjusted difference and p-value were calculated according to the Cochran-Mantel-Haenszel (CMH) test adjusted for strata (Baseline FG score \[\< 8, ≥ 8\], and baseline normal/obese status \[BMI \< 30, ≥ 30\]) for the comparison of between each elagolix group and placebo. If zero frequency occurred, the zero count was replaced by 0.1 to prevent dividing by zero.||3.49|-15.38|0.300
72349900|NCT03951077|144220912|SUPERIORITY||Adjusted Response Rate Difference|-5.9||||0.32|TWO_SIDED|90.0|-15.65|3.86|||Cochran-Mantel-Haenszel|||Across the strata, 90% CI for adjusted difference and p-value were calculated according to the CMH test adjusted for strata (Baseline FG score \[\< 8, ≥ 8\], and baseline normal/obese status \[BMI \< 30, ≥ 30\]) for the comparison of between each elagolix group and placebo. If zero frequency occurred, the zero count was replaced by 0.1 to prevent dividing by zero.||3.86|-15.65|0.320
72349901|NCT03951077|144220912|SUPERIORITY||Adjusted Response Rate Difference|-5.6||||0.315|TWO_SIDED|90.0|-14.87|3.59|||Cochran-Mantel-Haenszel|||Across the strata, 90% CI for adjusted difference and p-value were calculated according to the CMH test adjusted for strata (Baseline FG score \[\< 8, ≥ 8\], and baseline normal/obese status \[BMI \< 30, ≥ 30\]) for the comparison of between each elagolix group and placebo. If zero frequency occurred, the zero count was replaced by 0.1 to prevent dividing by zero.||3.59|-14.87|0.315
72349902|NCT03951077|144220912|SUPERIORITY||Adjusted Response Rate Difference|-6.7||||0.265|TWO_SIDED|90.0|-16.63|3.19|||Cochran-Mantel-Haenszel|||Across the strata, 90% CI for adjusted difference and p-value were calculated according to the CMH test adjusted for strata (Baseline FG score \[\< 8, ≥ 8\], and baseline normal/obese status \[BMI \< 30, ≥ 30\]) for the comparison of between each elagolix group and placebo. If zero frequency occurred, the zero count was replaced by 0.1 to prevent dividing by zero.||3.19|-16.63|0.265
72349903|NCT03951077|144220912|SUPERIORITY||Adjusted Response Rate Difference|-0.8||||0.914|TWO_SIDED|90.0|-13.1|11.48|||Cochran-Mantel-Haenszel|||Across the strata, 90% CI for adjusted difference and p-value were calculated according to the CMH test adjusted for strata (Baseline FG score \[\< 8, ≥ 8\], and baseline normal/obese status \[BMI \< 30, ≥ 30\]) for the comparison of between each elagolix group and placebo. If zero frequency occurred, the zero count was replaced by 0.1 to prevent dividing by zero.||11.48|-13.10|0.914
72349904|NCT03951077|144220913|SUPERIORITY||Least Squares (LS) Mean of Difference|-5.93|STANDARD_ERROR_OF_MEAN|3.429||0.087|TWO_SIDED|90.0|-11.628|-0.231|||MMRM|||P-value is from mixed-effect model repeated measure (MMRM) with the fixed categorical effects of treatment, visit, treatment-by-visit interaction, baseline FG score (\< 8, ≥ 8), and baseline normal/obese status (BMI \< 30, ≥ 30), participant as a random effect, and the continuous fixed covariate of baseline measurement. Model is based on unstructured variance covariance structure.||-0.231|-11.628|0.087
72349905|NCT03951077|144220913|SUPERIORITY||LS Mean of Difference|-8.83|STANDARD_ERROR_OF_MEAN|3.435||0.012|TWO_SIDED|90.0|-14.533|-3.118|||MMRM|||P-value is from MMRM with the fixed categorical effects of treatment, visit, treatment-by-visit interaction, baseline FG score (\< 8, ≥ 8), and baseline normal/obese status (BMI \< 30, ≥ 30), participant as a random effect, and the continuous fixed covariate of baseline measurement. Model is based on unstructured variance covariance structure.||-3.118|-14.533|0.012
72349906|NCT03951077|144220913|SUPERIORITY||LS Mean of Difference|-16.1|STANDARD_ERROR_OF_MEAN|3.356|<|0.001|TWO_SIDED|90.0|-21.673|-10.519|||MMRM|||P-value is from MMRM with the fixed categorical effects of treatment, visit, treatment-by-visit interaction, baseline FG score (\< 8, ≥ 8), and baseline normal/obese status (BMI \< 30, ≥ 30), participant as a random effect, and the continuous fixed covariate of baseline measurement. Model is based on unstructured variance covariance structure.||-10.519|-21.673|<0.001
72349907|NCT03951077|144220913|SUPERIORITY||LS Mean of Difference|-6.15|STANDARD_ERROR_OF_MEAN|3.593||0.091|TWO_SIDED|90.0|-12.116|-0.176|||MMRM|||P-value is from MMRM with the fixed categorical effects of treatment, visit, treatment-by-visit interaction, baseline FG score (\< 8, ≥ 8), and baseline normal/obese status (BMI \< 30, ≥ 30), participant as a random effect, and the continuous fixed covariate of baseline measurement. Model is based on unstructured variance covariance structure.||-0.176|-12.116|0.091
72349908|NCT03951077|144220913|SUPERIORITY||LS Mean of Difference|-11.72|STANDARD_ERROR_OF_MEAN|3.431|<|0.001|TWO_SIDED|90.0|-17.418|-6.016|||MMRM|||P-value is from MMRM with the fixed categorical effects of treatment, visit, treatment-by-visit interaction, baseline FG score (\< 8, ≥ 8), and baseline normal/obese status (BMI \< 30, ≥ 30), participant as a random effect, and the continuous fixed covariate of baseline measurement. Model is based on unstructured variance covariance structure.||-6.016|-17.418|< 0.001
72429169|NCT01009047|144369349|SUPERIORITY_OR_OTHER|||||||0.766||||||Change at Day 182: Disorganized thoughts - ANCOVA model with treatment groups (paliperidone ER, aripiprazole) and country as factors, and baseline value as a covariate was used.|ANCOVA|||||||0.766
72349909|NCT01395901|144220915|NON_INFERIORITY_OR_EQUIVALENCE|For the primary efficacy analysis, the confidence interval (CI) was built on the FAS using the stratum adjusted Mantel-Haenszel (MH) method with correction of continuity. The non-inferiority margin was -10%.|Risk Difference (RD)|-4.4|||||TWO_SIDED|95.0|-10.5|1.7||||||"The null hypothesis (H0) was stated as:~• H0 : CR 0-24 hr palonosetron - CR 0-24 hr ondansetron \<-10%~The alternative hypothesis (H1) was stated as:~• H1 : CR 0-24 hr palonosetron - CR 0-24 hr ondansetron \>-10%~A power of 80% was used for sample size computation."||1.7|-10.5|
72349910|NCT02123849|144220954|NON_INFERIORITY|The non-inferiority margin is 10% of the coefficient of variation (i.e., standard deviation divided by mean) which means that the changes in the signature score in the intermittent arm is no less than 90% of the coefficient of variation of the changes in the signature score in the continuous arm.||||||0.04|||||||t-test, 1 sided|||||||0.04
72349911|NCT02123849|144220955|OTHER|||||||0.84|||||||t-test, 2 sided|||||||0.84
72349912|NCT02123849|144220956|OTHER|||||||0.61|||||||t-test, 2 sided|||||||0.61
72349913|NCT02123849|144220957|OTHER|||||||1|||||||Fisher Exact|||||||1.00
72349914|NCT02123849|144220958|OTHER|||||||0.42|||||||t-test, 2 sided|||||||0.42
72349915|NCT02123849|144220959|NON_INFERIORITY|The non-inferiority margin is 10% of the coefficient of variation (i.e., standard deviation divided by mean) which means that the changes in the signature score in the intermittent arm is no less than 90% of the coefficient of variation of the changes in the signature score in the continuous arm.||||||0.97|||||||t-test, 1 sided|||||||0.97
72349916|NCT02123849|144220960|NON_INFERIORITY|The non-inferiority margin is 10% of the coefficient of variation (i.e., standard deviation divided by mean) which means that the changes in the signature score in the intermittent arm is no less than 90% of the coefficient of variation of the changes in the signature score in the continuous arm.||||||0.97|||||||t-test, 1 sided|||||||0.97
72349917|NCT02123849|144220961|NON_INFERIORITY|The non-inferiority margin is 10% of the coefficient of variation (i.e., standard deviation divided by mean) which means that the changes in the signature score in the intermittent arm is no less than 90% of the coefficient of variation of the changes in the signature score in the continuous arm.||||||0.06|||||||t-test, 1 sided|||||||0.06
72349918|NCT02178995|144220977|SUPERIORITY_OR_OTHER|||||||0.037||||||HRTSD p-value = 0.037; p \< 0.05 considered significant|ANOVA|Within-subjects contrasts, n=31, df=1||||||0.037
72349919|NCT02178995|144220977|SUPERIORITY_OR_OTHER|||||||0.055||||||D' p = 0.055. p \< 0.05 considered significant.|ANOVA|Within-subjects contrasts, placebo v 10mg v 20mg.||||||0.055
72349920|NCT02178995|144220977|SUPERIORITY_OR_OTHER|||||||0.758|||||||t-test, 2 sided|||HRTSD 10mg vs 20mg||||0.758
72349921|NCT02178995|144220977|SUPERIORITY_OR_OTHER|||||||0.499|||||||t-test, 2 sided|||d' 10mg vs 20mg||||0.499
72349922|NCT02178995|144220978|SUPERIORITY_OR_OTHER|||||||0.008|||||||ANOVA|||||||0.008
72349923|NCT02178995|144220978|SUPERIORITY_OR_OTHER|||||||0.071|||||||t-test, 2 sided|||SDMT 10mg vs 20mg||||0.071
72349924|NCT02178995|144220979|SUPERIORITY_OR_OTHER|||||||0.154|||||||ANOVA|||||||0.154
72349925|NCT02178995|144220979|SUPERIORITY_OR_OTHER|||||||0.779|||||||t-test, 2 sided|||MCG 10mg vs 20mg||||0.779
72349926|NCT02178995|144220980|SUPERIORITY_OR_OTHER||||||<|0.0001||||||HRTSD P\<0.0001|t-test, 2 sided|||Intra-group comparison, HRTSD||||<0.0001
72349927|NCT02178995|144220980|SUPERIORITY_OR_OTHER|||||||0.001||||||HRTSD p \<0.001 for healthy controls|t-test, 2 sided|||Intra-group comparison, HRTSD, healthy controls||||0.001
72349928|NCT02178995|144220980|SUPERIORITY_OR_OTHER|||||||0.322|||||||ANOVA|||Between-group comparisons by 2-way ANOVA, HRTSD||||0.322
72349929|NCT02178995|144220980|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||Intra-group comparison, epilepsy, D'||||<0.0001
72349930|NCT02178995|144220980|SUPERIORITY_OR_OTHER|||||||0.037|||||||t-test, 2 sided|||Intra-group analysis, healthy controls, d'||||0.037
72349931|NCT02178995|144220980|SUPERIORITY_OR_OTHER|||||||0.08|||||||ANOVA|||Intra-group analysis by 2-way ANOVA, d'||||0.08
72349932|NCT02178995|144220981|SUPERIORITY_OR_OTHER|||||||0.003|||||||t-test, 2 sided|||||||0.003
72349933|NCT02178995|144220981|SUPERIORITY_OR_OTHER|||||||0.022|||||||t-test, 2 sided|||||||0.022
72349934|NCT02178995|144220981|SUPERIORITY_OR_OTHER|||||||0.443|||||||ANOVA|||Group x time interaction by 2-way ANOVA||||0.443
72349935|NCT02178995|144220982|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
72349936|NCT02178995|144220982|SUPERIORITY_OR_OTHER|||||||0.004|||||||t-test, 2 sided|||||||0.004
72349937|NCT02178995|144220982|SUPERIORITY_OR_OTHER|||||||0.906|||||||ANOVA|||Between-groups analysis by 2-way ANOVA||||0.906
72349938|NCT02178995|144220983|SUPERIORITY_OR_OTHER|||||||0.274|||||||t-test, 2 sided|||||||0.274
72349939|NCT02178995|144220984|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
72349940|NCT02178995|144220985|SUPERIORITY_OR_OTHER|||||||0.04||||||Hits p = 0.04|ANOVA|||||||0.04
72349941|NCT02178995|144220985|SUPERIORITY_OR_OTHER|||||||0.038||||||Omissions p = 0.038|ANOVA|||||||0.038
72349942|NCT02178995|144220985|SUPERIORITY_OR_OTHER|||||||0.329||||||Commissions p = 0.329|ANOVA|||||||0.329
72349943|NCT02178995|144220985|SUPERIORITY_OR_OTHER|||||||0.876|||||||t-test, 2 sided|||Hits 10mg vs 20mg||||0.876
72349944|NCT02178995|144220985|SUPERIORITY_OR_OTHER|||||||0.932|||||||t-test, 2 sided|||Omissions 10mg vs 20mg||||0.932
72349945|NCT02178995|144220985|SUPERIORITY_OR_OTHER|||||||0.898|||||||t-test, 2 sided|||Commissions 10mg vs 20mg||||0.898
72349946|NCT02178995|144220986|SUPERIORITY_OR_OTHER|||||||0.7116|||||||t-test, 2 sided|||Comparison of baseline rate of seizures (expressed as seizures per 28 days) pre-trial against the rate experienced during the double-blind portion of our trial.||||0.7116
72349947|NCT02178995|144220987|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||Attention/Concentration subscale||||<0.0001
72349948|NCT02178995|144220987|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||Memory subscale||||<0.0001
72349949|NCT02178995|144220987|SUPERIORITY_OR_OTHER|||||||0.002|||||||t-test, 2 sided|||Language subscale||||0.002
72349950|NCT02178995|144220987|SUPERIORITY_OR_OTHER|||||||0.001|||||||t-test, 2 sided|||Energy/fatigue subscale||||0.001
72349951|NCT02178995|144220988|SUPERIORITY_OR_OTHER|||||||0.003|||||||t-test, 2 sided|||Hits v1 vs v5 epilepsy||||0.003
72349952|NCT02178995|144220988|SUPERIORITY_OR_OTHER|||||||0.033|||||||t-test, 2 sided|||Hits v1 vs v5 healthy||||0.033
72349953|NCT02178995|144220988|SUPERIORITY_OR_OTHER|||||||0.079|||||||ANOVA|||2-way ANOVA epilepsy vs healthy hits||||0.079
72349954|NCT02178995|144220988|SUPERIORITY_OR_OTHER|||||||0.001|||||||t-test, 2 sided|||Omissions epilepsy v1 vs v5||||0.001
72349955|NCT02178995|144220988|SUPERIORITY_OR_OTHER|||||||0.029|||||||t-test, 2 sided|||Omissions v1 vs v5 healthy||||0.029
72349956|NCT02178995|144220988|SUPERIORITY_OR_OTHER|||||||0.048|||||||t-test, 2 sided|||Epilepsy v healthy ANOVA Omissions||||0.048
72349957|NCT02178995|144220988|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||Commissions v1 vs v5 epilepsy||||<0.0001
72349958|NCT02178995|144220988|SUPERIORITY_OR_OTHER|||||||0.42|||||||t-test, 2 sided|||Commissions v1 vs v5 healthy||||0.42
72349959|NCT02178995|144220988|SUPERIORITY_OR_OTHER|||||||0.019|||||||ANOVA|||Healthy vs epilepsy ANOVA (2-way) commissions||||0.019
72349960|NCT02178995|144220989|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
72349961|NCT02178995|144220990|SUPERIORITY_OR_OTHER|||||||0.003||||||Note: Stimulant side-effect score \*decreased\* with addition of open-label stimulant.|t-test, 2 sided|||||||0.003
72349962|NCT02178995|144220991|SUPERIORITY_OR_OTHER|||||||0.014|||||||t-test, 2 sided|||BDI epilepsy v1 vs v5||||0.014
72349963|NCT02178995|144220991|SUPERIORITY_OR_OTHER|||||||0.04|||||||t-test, 2 sided|||Healthy controls BDI v1 vs v5||||0.04
72349964|NCT02178995|144220991|SUPERIORITY_OR_OTHER|||||||0.191|||||||t-test, 2 sided|||Between-group comparison 2-way ANOVA BDI||||0.191
72349965|NCT02178995|144220991|SUPERIORITY_OR_OTHER|||||||0.42|||||||t-test, 2 sided|||BAI visit 1 vs visit 5 epilepsy||||0.42
72349966|NCT02178995|144220991|SUPERIORITY_OR_OTHER|||||||0.477|||||||t-test, 2 sided|||BAI visit 1 vs visit 5 healthy controls||||0.477
72349967|NCT02178995|144220991|SUPERIORITY_OR_OTHER|||||||0.792|||||||ANOVA|||Between-groups comparison 2-way ANOVA BAI||||0.792
72349968|NCT02178995|144220991|SUPERIORITY_OR_OTHER|||||||0.045|||||||t-test, 2 sided|||AES visit 1 vs visit 5 epilepsy||||0.045
72429170|NCT01009047|144369349|SUPERIORITY_OR_OTHER|||||||0.984||||||Change at Day 56: Uncontrolled hostility/ excitement - ANCOVA model with treatment groups (paliperidone ER, aripiprazole) and country as factors, and baseline value as a covariate was used.|ANCOVA|||||||0.984
72429171|NCT01009047|144369349|SUPERIORITY_OR_OTHER|||||||0.985||||||Change at Day 182: Uncontrolled Hositility/ Excitement - ANCOVA model with treatment groups (paliperidone ER, aripiprazole) and country as factors, and baseline value as a covariate was used.|ANCOVA|||||||0.985
72349969|NCT02178995|144220991|SUPERIORITY_OR_OTHER|||||||0.646|||||||t-test, 2 sided|||AES visit 1 vs visit 5 healthy controls||||0.646
72349970|NCT02178995|144220991|SUPERIORITY_OR_OTHER|||||||0.222|||||||ANOVA|||Between-groups comparison 2-way ANOVA AES||||0.222
72429172|NCT01009047|144369349|SUPERIORITY_OR_OTHER|||||||0.803||||||Change at Day 56: Anxiety/ depression - ANCOVA model with treatment groups (paliperidone ER, aripiprazole) and country as factors, and baseline value as a covariate.|ANCOVA|||||||0.803
72349971|NCT02178995|144220992|SUPERIORITY_OR_OTHER|||||||0.011|||||||t-test, 2 sided|||Health Perceptions||||0.011
72349972|NCT02178995|144220992|SUPERIORITY_OR_OTHER|||||||0.01|||||||t-test, 2 sided|||Overall QOL (subjectively rated by participants on the scale)||||0.01
72349973|NCT02178995|144220992|SUPERIORITY_OR_OTHER|||||||0.164|||||||t-test, 2 sided|||Physical Function||||0.164
72349974|NCT02178995|144220992|SUPERIORITY_OR_OTHER|||||||0.065|||||||t-test, 2 sided|||Role Limitations (Emotional)||||0.065
72349975|NCT02178995|144220992|SUPERIORITY_OR_OTHER|||||||0.014|||||||t-test, 2 sided|||Role Limitations (Physical)||||0.014
72349976|NCT02178995|144220992|SUPERIORITY_OR_OTHER|||||||0.128|||||||t-test, 2 sided|||Pain||||0.128
72349977|NCT02178995|144220992|SUPERIORITY_OR_OTHER|||||||0.026|||||||t-test, 2 sided|||Work/Driving/Social||||0.026
72349978|NCT02178995|144220992|SUPERIORITY_OR_OTHER|||||||0.077|||||||t-test, 2 sided|||Emotional Wellbeing||||0.077
72349979|NCT02178995|144220992|SUPERIORITY_OR_OTHER|||||||0.007|||||||t-test, 2 sided|||Health Discouragement||||0.007
72349980|NCT02178995|144220992|SUPERIORITY_OR_OTHER|||||||0.063|||||||t-test, 2 sided|||Seizure Worry||||0.063
72349981|NCT02178995|144220992|SUPERIORITY_OR_OTHER|||||||0.609|||||||t-test, 2 sided|||Medication Effects||||0.609
72349982|NCT02178995|144220992|SUPERIORITY_OR_OTHER|||||||0.626|||||||t-test, 2 sided|||Social Support||||0.626
72349983|NCT02178995|144220992|SUPERIORITY_OR_OTHER|||||||0.103|||||||t-test, 2 sided|||Social Isolation||||0.103
72349984|NCT02178995|144220993|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||Variability v1 vs v5 epilepsy||||<0.0001
72349985|NCT02178995|144220993|SUPERIORITY_OR_OTHER|||||||0.096|||||||t-test, 2 sided|||Variability v1 vs v5 healthy||||0.096
72349986|NCT02178995|144220993|SUPERIORITY_OR_OTHER|||||||0.136|||||||ANOVA|||Variability 2-way ANOVA healthy vs epilepsy||||0.136
72349987|NCT02178995|144220993|SUPERIORITY_OR_OTHER|||||||0.17|||||||t-test, 2 sided|||Perseverations v1 vs v5 epilepsy||||0.17
72349988|NCT02178995|144220993|SUPERIORITY_OR_OTHER|||||||0.104|||||||t-test, 2 sided|||Perseverations v1 vs v5 healthy||||0.104
72349989|NCT02178995|144220993|SUPERIORITY_OR_OTHER|||||||0.661|||||||ANOVA|||Perseverations 2-way ANOVA healthy vs epilepsy||||0.661
72349990|NCT02178995|144220994|SUPERIORITY_OR_OTHER|||||||0.397|||||||ANOVA|||Variability ANOVA||||0.397
72349991|NCT02178995|144220994|SUPERIORITY_OR_OTHER|||||||0.745|||||||ANOVA|||Perseverations ANOVA||||0.745
72349992|NCT02178995|144220994|SUPERIORITY_OR_OTHER|||||||0.362|||||||t-test, 2 sided|||10mg vs 20mg variability||||0.362
72349993|NCT02178995|144220994|SUPERIORITY_OR_OTHER|||||||0.745|||||||t-test, 2 sided|||10mg vs 20mg perseverations||||0.745
72349994|NCT02178995|144220995|SUPERIORITY_OR_OTHER|||||||0.48|||||||ANOVA|||HRT ANOVA||||0.48
72349995|NCT02178995|144220995|SUPERIORITY_OR_OTHER|||||||0.793|||||||t-test, 2 sided|||HRT 10mg vs 20mg||||0.793
72349996|NCT02178995|144220996|SUPERIORITY_OR_OTHER|||||||0.5|||||||t-test, 2 sided|||HRT v1 vs v5 epilepsy||||0.5
72349997|NCT02178995|144220996|SUPERIORITY_OR_OTHER|||||||0.075|||||||t-test, 2 sided|||HRT v1 vs v5 healthy||||0.075
72349998|NCT02178995|144220996|SUPERIORITY_OR_OTHER|||||||0.2|||||||ANOVA|||HRT epilepsy vs healthy ANOVA||||0.2
72349999|NCT05258149|144221006|SUPERIORITY|A superiority margin of 1 was used.|Odds Ratio (OR)|1.65|||||TWO_SIDED|95.0|1.1|2.46|||Generalized Linear Mixed Model|Kenward and Roger Method was used for the denominator degrees of freedom.|Odds Ratio was calculated as senofilcon A C3 over delefilcon A|||2.46|1.10|
72350000|NCT05258149|144221007|SUPERIORITY|A superiority margin of 1 was used.|Odds Ratio (OR)|1.88|||||TWO_SIDED|95.0|1.27|2.79|||Generalized Linear Mixed Model|Kenward and Roger Method was used for the denominator degrees of freedom.|Odds Ratio was calculated as senofilcon A C3 over delefilcon A|||2.79|1.27|
72350001|NCT05258149|144221008|NON_INFERIORITY|A Non-Inferiority margin of 10% was used.|Odds Ratio (OR)|0.74|||||TWO_SIDED|98.33|0.42|1.3|||Generalized Linear Mixed Model|Kenward and Roger Method was used for the denominator degrees of freedom.|Odds Ratio was calculated as senofilcon A C3 over delefilcon A||confidence intervals were adjusted using 98.33% per each secondary endpoint|1.30|0.42|
72350002|NCT05258149|144221009|SUPERIORITY|A superiority margin of 1 was used.|Odds Ratio (OR)|1.58|||||TWO_SIDED|98.33|0.91|2.75|||Generalized Linear Mixed Model|Kenward and Roger Method was used for the denominator degrees of freedom.|Odds Ratio was calculated as senofilcon A C3 over delefilcon A||confidence intervals were adjusted using 98.33% per each secondary endpoint|2.75|0.91|
72350003|NCT05258149|144221010|SUPERIORITY|A superiority margin of 1 was used.|Odds Ratio (OR)|2.08|||||TWO_SIDED|98.33|1.24|3.5|||Generalized Linear Mixed Model|Kenward and Roger Method was used for the denominator degrees of freedom.|Odds Ratio was calculated as senofilcon A C3 over delefilcon A||confidence intervals were adjusted using 98.33% per each secondary endpoint|3.50|1.24|
72350004|NCT02152761|144221060|SUPERIORITY||Treatment Group Ratio (BYM - Placebo)|1.057|||<|0.0001|TWO_SIDED|95.0|1.037|1.076|||Mixed Models Analysis||Holm-Bonferroni method: Used to adjust the Type I error for two comparisons (BYM338 700 mg/Placebo) at Week 24. No control for multiplicity was made at Week 12.|week 12||1.076|1.037|<.0001
72350005|NCT02152761|144221060|SUPERIORITY||Treatment group rratio (BYM - Placebo)|1.043|||<|0.0001|TWO_SIDED|95.0|1.024|1.064|||Mixed Models Analysis||Holm-Bonferroni method: Used to adjust the Type I error for two comparisons (BYM338 700 mg/Placebo) at Week 24. No control for multiplicity was made at Week 12.|week 12||1.064|1.024|<.0001
72350006|NCT02152761|144221061|SUPERIORITY||LS Mean of Treatment Difference|-0.071||||0.1829|TWO_SIDED|95.0|-0.175|0.034||Treatment Difference (BYM-Placebo)|Mixed Models Analysis|||week 24||0.034|-0.175|0.1829
72350007|NCT02152761|144221061|SUPERIORITY||LS Mean of Treatment Difference|0.011||||0.8365|TWO_SIDED|95.0|-0.096|0.119|||Mixed Models Analysis|||week 24||0.119|-0.096|0.8365
72350008|NCT02152761|144221062|SUPERIORITY||LS Mean of Treatment Difference|-0.371||||0.5802|TWO_SIDED|95.0|-1.311|1.053|||Mixed Models Analysis|||week 24||1.053|-1.311|0.5802
72350009|NCT02152761|144221062|SUPERIORITY||LS Mean of the Treatment Difference|0.833||||0.0913|TWO_SIDED|95.0|-0.135|1.801|||Mixed Models Analysis|||week 24||1.801|-0.135|0.0913
72350010|NCT02152761|144221063|SUPERIORITY||Falls Rate Ratio|1.08||||0.8353|TWO_SIDED|95.0|0.53|2.21|||Negative binomial regression|||||2.21|0.53|0.8353
72350011|NCT02152761|144221063|SUPERIORITY||Falls Rate Ratio|1.58||||0.2015|TWO_SIDED|95.0|0.78|3.18|||Negative binomial regression|||||3.18|0.78|0.2015
72350012|NCT02152761|144221063|SUPERIORITY||Falls Rate Ratio|1.25||||0.3999|TWO_SIDED|95.0|0.52|3.0|||Negative binomial regression|||week 24||3.00|0.52|0.3999
72350013|NCT02859246|144221082|SUPERIORITY||||||<|0.04||||||A two tail P value of less than 0.05 was considered statistically significant.|Wilcoxon (Mann-Whitney)|||||||<0.04
72350014|NCT02859246|144221083|SUPERIORITY||||||<|0.2||||||A two tail P value of less than 0.05 was considered statistically significant.|Wilcoxon (Mann-Whitney)|||||||< 0.2
72350015|NCT05280717|144221086|OTHER||Ratio of geometric least square mean|0.9821|||||TWO_SIDED|90.0|0.8825|1.093|||||The ratio estimate and 90% confidence interval were obtained from an Analysis of covariance (ANCOVA) model, with AUC(D1- 29) as the dependent variable, and sex, baseline body mass index and treatment as covariates.|||1.0930|0.8825|
72350016|NCT05280717|144221087|OTHER||Ratio of geometric least square mean|1.1258|||||TWO_SIDED|90.0|1.0108|1.2539|||||The ratio estimate and 90% confidence interval were obtained from an ANCOVA model, with Cmax as the dependent variable, and sex, baseline body mass index and treatment as covariates.|||1.2539|1.0108|
72350017|NCT05280717|144221090|OTHER||Ratio of geometric least square mean|1.876|||||TWO_SIDED|90.0|1.6391|2.1472|||||The ratio estimate and 90% confidence interval were obtained from an ANCOVA model, with AUC(D1-29) as the dependent variable, and sex, baseline body mass index and treatment as covariates.|||2.1472|1.6391|
72429173|NCT01009047|144369349|SUPERIORITY_OR_OTHER|||||||0.745||||||Change at Day 182: Anxiety/ depression - ANCOVA model with treatment groups (paliperidone ER, aripiprazole) and country as factors, and baseline value as a covariate.|ANCOVA|||||||0.745
72429174|NCT01009047|144369351|SUPERIORITY_OR_OTHER|||||||0.296||||||Generalized Cochran- Mantel- Haenszel test for row mean score differences controlling for country was used.|Cochran-Mantel-Haenszel|||||||0.296
72350018|NCT05280717|144221090|OTHER||Ratio of geometric least square mean|1.5991|||||TWO_SIDED|90.0|1.4086|1.8153|||||The ratio estimate and 90% confidence interval were obtained from an ANCOVA model, with AUC(D1-29) as the dependent variable, and sex, baseline body mass index and treatment as covariates.|||1.8153|1.4086|
72350019|NCT05280717|144221091|OTHER||Ratio of geometric least square mean|2.0798|||||TWO_SIDED|90.0|1.8223|2.3737|||||The ratio estimate and 90% confidence interval were obtained from an ANCOVA model, with Cmax as the dependent variable, and sex, baseline body mass index and treatment as covariates.|||2.3737|1.8223|
72350020|NCT05280717|144221091|OTHER||Ratio of geometric least square mean|1.6955|||||TWO_SIDED|90.0|1.4913|1.9276|||||The ratio estimate and 90% confidence interval were obtained from an ANCOVA model, with Cmax as the dependent variable, and sex, baseline body mass index and treatment as covariates.|||1.9276|1.4913|
72350021|NCT05280717|144221096|OTHER||Ratio of geometric least square mean|0.9476|||||TWO_SIDED|90.0|0.8578|1.0469|||||The ratio estimate and 90% confidence interval were obtained from an ANCOVA model, with AUCinf as the dependent variable, and sex, baseline body mass index and treatment as covariates.|||1.0469|0.8578|
72350022|NCT05280717|144221096|OTHER||Ratio of geometric least square mean|1.5482|||||TWO_SIDED|90.0|1.377|1.7407|||||The ratio estimate and 90% confidence interval were obtained from an ANCOVA model, with AUCinf as the dependent variable, and sex, baseline body mass index and treatment as covariates.|||1.7407|1.3770|
72350023|NCT05280717|144221096|OTHER||Ratio of geometric least square mean|1.4167|||||TWO_SIDED|90.0|1.2627|1.5894|||||The ratio estimate and 90% confidence interval were obtained from an ANCOVA model, with AUCinf as the dependent variable, and sex, baseline body mass index and treatment as covariates.|||1.5894|1.2627|
72350024|NCT04209205|144221105|SUPERIORITY||Marginal difference|25.02|||<|0.0001|TWO_SIDED|95.0|17.61|32.43|||Regression, Logistic|||||32.43|17.61|<.0001
72350025|NCT04209205|144221106|SUPERIORITY||Marginal difference|30.59|||<|0.0001|TWO_SIDED|95.0|21.14|40.05|||Regression, Logistic|||||40.05|21.14|<.0001
72350026|NCT04209205|144221107|SUPERIORITY||Marginal difference|17.17|||<|0.0001|TWO_SIDED|95.0|10.48|23.85|||Regression, Logistic|||||23.85|10.48|<.0001
72350027|NCT04209205|144221108|SUPERIORITY||Marginal difference|41.39|||<|0.0001|TWO_SIDED|95.0|30.64|52.13|||Regression, Logistic|||||52.13|30.64|<.0001
72350028|NCT04209205|144221109|SUPERIORITY||Least squares mean|-1.13|STANDARD_ERROR_OF_MEAN|0.129|<|0.0001|TWO_SIDED|95.0|-1.38|0.87|||Mixed Models Analysis|||||0.87|-1.38|<.0001
72350029|NCT04209205|144221110|SUPERIORITY||Least squares mean|-0.24|STANDARD_ERROR_OF_MEAN|-0.043|<|0.0001|TWO_SIDED|95.0|-0.32|0.15|||Mixed Models Analysis|||||0.15|-0.32|<.0001
72350030|NCT04209205|144221111|SUPERIORITY||Least squares mean|4.13|STANDARD_ERROR_OF_MEAN|0.676|<|0.0001|TWO_SIDED|95.0|2.8|5.46|||Mixed Models Analysis|||||5.46|2.80|<.0001
72350031|NCT04209205|144221112|SUPERIORITY||Least squares mean|2.85|STANDARD_ERROR_OF_MEAN|0.933||0.0024|TWO_SIDED|95.0|1.01|4.68|||Mixed Models Analysis|||||4.68|1.01|0.0024
72350032|NCT04209205|144221113|SUPERIORITY||Least squares mean|-6.11|STANDARD_ERROR_OF_MEAN|1.447|<|0.0001|TWO_SIDED|95.0|-8.96|-3.26|||Mixed Models Analysis|||||-3.26|-8.96|<.0001
72350033|NCT04209205|144221114|SUPERIORITY||Marginal difference|27.49||||0.0003|TWO_SIDED|95.0|12.43|42.55|||Regression, Logistic|||||42.55|12.43|0.0003
72350034|NCT04209205|144221115|SUPERIORITY||Marginal difference|16.35||||0.0102|TWO_SIDED|95.0|3.88|28.82|||Regression, Logistic|||||28.82|3.88|0.0102
72350035|NCT05236257|144221119|OTHER||Hazard Ratio (HR)|0.21||||0.0058|TWO_SIDED|95.0|0.07|0.63|||Cox Proportional Hazards model|Unweighted||||0.63|0.07|0.0058
72350036|NCT05236257|144221119|OTHER|||||||0.0023|||||||Log Rank|Unweighted||||||0.0023
72350037|NCT05236257|144221120|OTHER||Hazard Ratio (HR)|0.23||||0.0703|TWO_SIDED|95.0|0.05|1.13|||Cox Proportional Hazards model|Unweighted||||1.13|0.05|0.0703
72350038|NCT05236257|144221120|OTHER|||||||0.0486|||||||Log Rank|Unweighted||||||0.0486
72350039|NCT05236257|144221121|OTHER||Hazard Ratio (HR)|0.23||||0.696|TWO_SIDED|95.0|0.05|1.12|||Cox Proportional Hazards model|Unweighted||||1.12|0.05|0.696
72350040|NCT05236257|144221121|OTHER|||||||0.0476|||||||Log Rank|Unweighted||||||0.0476
72350041|NCT05236257|144221123|OTHER||Hazard Ratio (HR)|0.79||||0.5713|TWO_SIDED|95.0|0.36|1.77|||Cox Proportional Hazards model|Unweighted||||1.77|0.36|0.5713
72350042|NCT05236257|144221123|OTHER|||||||0.5695|||||||Log Rank|Unweighted||||||0.5695
72350043|NCT05236257|144221124|OTHER||Hazard Ratio (HR)|0.32||||0.32|TWO_SIDED|95.0|0.03|3.06|||Cox Proportional Hazards model|Unweighted||||3.06|0.03|0.3200
72350044|NCT05236257|144221124|OTHER|||||||0.294|||||||Log Rank|Unweighted||||||0.2940
72429175|NCT01009047|144369352|SUPERIORITY_OR_OTHER|||||||0.843||||||Change at Day 56: ANCOVA model on ranks with treatment groups (paliperidone ER, aripiprazole) and country as factors, and baseline value (unranked) as a covariate was used.|ANCOVA|||||||0.843
72429176|NCT01009047|144369352|SUPERIORITY_OR_OTHER|||||||0.914||||||Change at Day 182: ANCOVA model on ranks with treatment groups (paliperidone ER, aripiprazole) and country as factors, and baseline value (unranked) as a covariate was used.|ANCOVA|||||||0.914
72350045|NCT03071393|144221126|SUPERIORITY||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
72350046|NCT03071393|144221127|SUPERIORITY||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
72429177|NCT01009047|144369353|SUPERIORITY_OR_OTHER||LS mean difference|0.2|STANDARD_ERROR_OF_MEAN|1.27||0.895|TWO_SIDED|95.0|-2.34|2.67||Change at Day 56: Analysis of covariance (ANCOVA) model with treatment groups(paliperidone ER, aripiprazole) and country as factors, and baseline value as a covariate was used.|ANCOVA|||||2.67|-2.34|0.895
72350047|NCT03071393|144221128|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<0.05
72350048|NCT03071393|144221129|SUPERIORITY||||||<|0.05||||||Uncorrected p values are reported.|Wilcoxon (Mann-Whitney)|||||||<0.05
72350049|NCT00874848|144221135|SUPERIORITY_OR_OTHER|||||||0.2895|||||||Fisher Exact|||||||0.2895
72350050|NCT03559933|144221141|SUPERIORITY||Logistic regression model|95.0|STANDARD_ERROR_OF_MEAN|0.0152||0.0125|TWO_SIDED|95.0|93.15|96.66|||Mixed Models Analysis|Subject and stimulation within subject as random effects with multiple observations per subject was accounted for.||The proportion of successful capture was analyzed using a generalized linear mixed model accounting for subject and stimulation within subject as random effects with multiple observations per subject. The null hypothesis was tested comparing the lower bound of the 98.75% two-sided confidence interval for the estimated percent diaphragm capture rate to the performance goal of 80%. If the lower bound was greater than 80%, the null hypothesis was rejected, and the endpoint was considered met.||96.66|93.15|0.0125
72350051|NCT02324816|144221147|OTHER||success proportion|73.7|||||TWO_SIDED|95.0|48.8|90.9||||||||90.9|48.8|
72350052|NCT05169424|144221148|OTHER|Comparison of Stiolto (reference group) versus Trelegy for incidence rate of exacerbation.|Hazard Ratio (HR)|1.133||||0.064|TWO_SIDED|95.0|0.993|1.293|||Regression, Cox|Cox regression was for time to first exacerbation and cohort as covariate.||||1.293|0.993|0.064
72350053|NCT05169424|144221148|OTHER|||||||0.045|||||||Wilcoxon (Mann-Whitney)|||||||0.045
72350054|NCT05169424|144221148|OTHER|||||||0.063|||||||Log Rank|||||||0.063
72350055|NCT05169424|144221149|OTHER|Comparison of Stiolto (reference group) versus Trelegy.|Hazard Ratio (HR)|1.169||||0.057|TWO_SIDED|95.0|0.996|1.372|||Regression, Cox|Cox regression was for time to first exacerbation and cohort as covariate.||||1.372|0.996|0.057
72350056|NCT05169424|144221150|OTHER|Comparison of Stiolto (reference group) versus Trelegy.|Hazard Ratio (HR)|1.116||||0.114|TWO_SIDED|95.0|0.974|1.279|||Regression, Cox|Cox regression was for time to first exacerbation and cohort as covariate.||||1.279|0.974|0.114
72350057|NCT05169424|144221151|OTHER|Comparison of Stiolto (reference group) versus Trelegy.|Hazard Ratio (HR)|1.374||||0.273|TWO_SIDED|95.0|0.779|2.424|||Regression, Cox|Cox regression was for time to first exacerbation and cohort as covariate.||||2.424|0.779|0.273
72350058|NCT05169424|144221152|OTHER|Comparison of Stiolto (reference) versus Trelegy for incidence rate of pneumonia hospitalization.|Hazard Ratio (HR)|1.183||||0.429|TWO_SIDED|95.0|0.78|1.792|||Regression, Cox|||||1.792|0.780|0.429
72350059|NCT05169424|144221152|OTHER|||||||0.896|||||||Wilcoxon (Mann-Whitney)|||||||0.896
72350060|NCT05169424|144221152|OTHER|||||||0.932|||||||Log Rank|||||||0.932
72350061|NCT05169424|144221153|OTHER|Comparison of Stiolto (reference) versus Trelegy for incidence rate of pneumonia hospitalization.|Hazard Ratio (HR)|0.979||||0.935|TWO_SIDED|95.0|0.582|1.645|||Regression, Cox|||||1.645|0.582|0.935
72350062|NCT05169424|144221154|OTHER|Comparison of Stiolto (reference) versus Trelegy for incidence rate of pneumonia hospitalization.|Hazard Ratio (HR)|1.159||||0.507|TWO_SIDED|95.0|0.75|1.79|||Regression, Cox|||||1.790|0.750|0.507
72350063|NCT05169424|144221155|OTHER|Comparison of Stiolto (reference) versus Trelegy for incidence rate of pneumonia hospitalization.|Hazard Ratio (HR)|1.291||||0.726|TWO_SIDED|95.0|0.309|5.405|||Regression, Cox|||||5.405|0.309|0.726
72350064|NCT05169424|144221156|OTHER|||||||0.874|||||||t-test, 2 sided|||||||0.874
72350065|NCT05169424|144221156|OTHER||Exponential estimate|0.895||||0.01|TWO_SIDED|95.0|0.823|0.974|||ZINB regression with log link|The costs were modeled using Zero Inflated Negative Binomial (ZINB) regression with log link with cohort as the only covariate.|The analysis was for Stiolto versus Trlegy (Trelegy was the reference group).|||0.974|0.823|0.01
72350066|NCT05169424|144221157|OTHER|||||||0.899|||||||t-test, 2 sided|||||||0.899
72350067|NCT05169424|144221157|OTHER||Exponential estimate|0.897||||0.012|TWO_SIDED|95.0|0.824|0.976|||ZINB regression with log link|The costs were modeled using Zero Inflated Negative Binomial (ZINB) regression with log link with cohort as the only covariate.|The analysis was for Stiolto versus Trlegy (Trelegy was the reference group).|||0.976|0.824|0.012
72350068|NCT05169424|144221158|OTHER|||||||0.974|||||||t-test, 2 sided|||||||0.974
72350069|NCT05169424|144221158|OTHER||Exponential estimate|1.135||||0.595|TWO_SIDED|95.0|0.711|1.812|||ZINB regression with log link|The costs were modeled using Zero Inflated Negative Binomial (ZINB) regression with log link with cohort as the only covariate.|The analysis was for Stiolto versus Trlegy (Trelegy was the reference group).|||1.812|0.711|0.595
72350070|NCT05169424|144221159|OTHER|||||||0.622|||||||t-test, 2 sided|||||||0.622
72350071|NCT05169424|144221159|OTHER||Exponential estimate|1.008||||0.855|TWO_SIDED|95.0|0.928|1.094|||ZINB regression with log link|The costs were modeled using Zero Inflated Negative Binomial (ZINB) regression with log link with cohort as the only covariate.|The analysis was for Stiolto versus Trlegy (Trelegy was the reference group).|||1.094|0.928|0.855
72350072|NCT05169424|144221160|OTHER|||||||0.328|||||||t-test, 2 sided|||||||0.328
72350073|NCT03197376|144221200|EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the GMC of IgG antibody at one month following third vaccination was within this equivalence interval for each serotype 1, Lot 1 and Lot 2 would be equivalent with respect to the immune response to the vaccine lot|Pn IgG type 1 GMC Ratio|0.96|||||TWO_SIDED|95.0|0.88|1.05||||||The 3 lots were to be considered equivalent if, for each serotype, all 3 CIs for IgG GMC ratios 4 weeks after the primary vaccination series lay within the interval (0.5, 2)||1.05|0.88|
72350074|NCT03197376|144221200|EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the GMC of IgG antibody at one month following third vaccination was within this equivalence interval for serotype 5, Lot 1 and Lot 2 would be equivalent with respect to the immune response to the vaccine lot|Pn IgG type 5 GMC Ratio|0.75|||||TWO_SIDED|95.0|0.69|0.81||||||The 3 lots were to be considered equivalent if, for each serotype, all 3 CIs for IgG GMC ratios 4 weeks after the primary vaccination series lay within the interval (0.5, 2)||0.81|0.69|
72350075|NCT03197376|144221200|EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the GMC of IgG antibody at one month following third vaccination was within this equivalence interval for serotype 6A, Lot 1 and Lot 2 would be equivalent with respect to the immune response to the vaccine lot|Pn IgG type 6A GMC Ratio|1.1|||||TWO_SIDED|95.0|0.96|1.26||||||The 3 lots were to be considered equivalent if, for each serotype, all 3 CIs for IgG GMC ratios 4 weeks after the primary vaccination series lay within the interval (0.5, 2)||1.26|0.96|
72350076|NCT03197376|144221200|EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the GMC of IgG antibody at one month following third vaccination was within this equivalence interval for serotype 6B, Lot 1 and Lot 2 would be equivalent with respect to the immune response to the vaccine lot|Pn IgG type 6B GMC Ratio|1.41|||||TWO_SIDED|95.0|1.18|1.69||||||The 3 lots were to be considered equivalent if, for each serotype, all 3 CIs for IgG GMC ratios 4 weeks after the primary vaccination series lay within the interval (0.5, 2)||1.69|1.18|
72350077|NCT03197376|144221200|EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the GMC of IgG antibody at one month following third vaccination was within this equivalence interval for serotype 7F, Lot 1 and Lot 2 would be equivalent with respect to the immune response to the vaccine lot|Pn IgG type 7F GMC Ratio|1.09|||||TWO_SIDED|95.0|0.99|1.2||||||The 3 lots were to be considered equivalent if, for each serotype, all 3 CIs for IgG GMC ratios 4 weeks after the primary vaccination series lay within the interval (0.5, 2)||1.20|0.99|
72350078|NCT03197376|144221200|EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the GMC of IgG antibody at one month following third vaccination was within this equivalence interval for serotype 9V, Lot 1 and Lot 2 would be equivalent with respect to the immune response to the vaccine lot|Pn IgG type 9V GMC Ratio|1.08|||||TWO_SIDED|95.0|0.98|1.18||||||The 3 lots were to be considered equivalent if, for each serotype, all 3 CIs for IgG GMC ratios 4 weeks after the primary vaccination series lay within the interval (0.5, 2)||1.18|0.98|
72350079|NCT03197376|144221200|EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the GMC of IgG antibody at one month following third vaccination was within this equivalence interval for serotype 14, Lot 1 and Lot 2 would be equivalent with respect to the immune response to the vaccine lot|Pn IgG type 14 GMC Ratio|0.93|||||TWO_SIDED|95.0|0.81|1.07||||||The 3 lots were to be considered equivalent if, for each serotype, all 3 CIs for IgG GMC ratios 4 weeks after the primary vaccination series lay within the interval (0.5, 2)||1.07|0.81|
72350080|NCT03197376|144221200|EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the GMC of IgG antibody at one month following third vaccination was within this equivalence interval for serotype 19A, Lot 1 and Lot 2 would be equivalent with respect to the immune response to the vaccine lot|Pn IgG type 19A GMC Ratio|0.93|||||TWO_SIDED|95.0|0.83|1.04||||||The 3 lots were to be considered equivalent if, for each serotype, all 3 CIs for IgG GMC ratios 4 weeks after the primary vaccination series lay within the interval (0.5, 2)||1.04|0.83|
72350081|NCT03197376|144221200|EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the GMC of IgG antibody at one month following third vaccination was within this equivalence interval for serotype 19F, Lot 1 and Lot 2 would be equivalent with respect to the immune response to the vaccine lot|Pn IgG type 19F GMC Ratio|0.84|||||TWO_SIDED|95.0|0.76|0.92||||||The 3 lots were to be considered equivalent if, for each serotype, all 3 CIs for IgG GMC ratios 4 weeks after the primary vaccination series lay within the interval (0.5, 2)||0.92|0.76|
72350082|NCT03197376|144221200|EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the GMC of IgG antibody at one month following third vaccination was within this equivalence interval for serotype 23F, Lot 1 and Lot 2 would be equivalent with respect to the immune response to the vaccine lot|Pn IgG type 23F GMC Ratio|1.02|||||TWO_SIDED|95.0|0.91|1.15||||||The 3 lots were to be considered equivalent if, for each serotype, all 3 CIs for IgG GMC ratios 4 weeks after the primary vaccination series lay within the interval (0.5, 2)||1.15|0.91|
72350083|NCT03197376|144221200|EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the GMC of IgG antibody at one month following third vaccination was within this equivalence interval for serotype 1, Lot 1 and Lot 3 would be equivalent with respect to the immune response to the vaccine lot|Pn IgG type 1 GMC Ratio|0.89|||||TWO_SIDED|95.0|0.82|0.97||||||The 3 lots were to be considered equivalent if, for each serotype, all 3 CIs for IgG GMC ratios 4 weeks after the primary vaccination series lay within the interval (0.5, 2)||0.97|0.82|
72350084|NCT03197376|144221200|EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the GMC of IgG antibody at one month following third vaccination was within this equivalence interval for serotype 5, Lot 1 and Lot 3 would be equivalent with respect to the immune response to the vaccine lot|Pn IgG type 5 GMC Ratio|0.73|||||TWO_SIDED|95.0|0.67|0.8||||||The 3 lots were to be considered equivalent if, for each serotype, all 3 CIs for IgG GMC ratios 4 weeks after the primary vaccination series lay within the interval (0.5, 2||0.80|0.67|
72350085|NCT03197376|144221200|EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the GMC of IgG antibody at one month following third vaccination was within this equivalence interval for serotype 6A, Lot 1 and Lot 3 would be equivalent with respect to the immune response to the vaccine lot|Pn IgG type 6A GMC Ratio|1.04|||||TWO_SIDED|95.0|0.91|1.2||||||The 3 lots were to be considered equivalent if, for each serotype, all 3 CIs for IgG GMC ratios 4 weeks after the primary vaccination series lay within the interval (0.5, 2||1.20|0.91|
72350086|NCT03197376|144221200|EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the GMC of IgG antibody at one month following third vaccination was within this equivalence interval for serotype 6B, Lot 1 and Lot 3 would be equivalent with respect to the immune response to the vaccine lot|Pn IgG type 6B GMC Ratio|0.87|||||TWO_SIDED|95.0|0.74|1.04||||||The 3 lots were to be considered equivalent if, for each serotype, all 3 CIs for IgG GMC ratios 4 weeks after the primary vaccination series lay within the interval (0.5, 2)||1.04|0.74|
72350087|NCT03197376|144221200|EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the GMC of IgG antibody at one month following third vaccination was within this equivalence interval for serotype 7F, Lot 1 and Lot 3 would be equivalent with respect to the immune response to the vaccine lot|Pn IgG type 7F GMC Ratio|0.75|||||TWO_SIDED|95.0|0.68|0.83||||||The 3 lots were to be considered equivalent if, for each serotype, all 3 CIs for IgG GMC ratios 4 weeks after the primary vaccination series lay within the interval (0.5, 2)||0.83|0.68|
72350088|NCT03197376|144221200|EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the GMC of IgG antibody at one month following third vaccination was within this equivalence interval for serotype 9V, Lot 1 and Lot 3 would be equivalent with respect to the immune response to the vaccine lot|Pn IgG type 9V GMC Ratio|0.88|||||TWO_SIDED|95.0|0.8|0.97||||||The 3 lots were to be considered equivalent if, for each serotype, all 3 CIs for IgG GMC ratios 4 weeks after the primary vaccination series lay within the interval (0.5, 2)||0.97|0.80|
72350089|NCT03197376|144221200|EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the GMC of IgG antibody at one month following third vaccination was within this equivalence interval for serotype 14, Lot 1 and Lot 3 would be equivalent with respect to the immune response to the vaccine lot|Pn IgG type 14 GMC Ratio|0.95|||||TWO_SIDED|95.0|0.83|1.09||||||The 3 lots were to be considered equivalent if, for each serotype, all 3 CIs for IgG GMC ratios 4 weeks after the primary vaccination series lay within the interval (0.5, 2)||1.09|0.83|
72350090|NCT03197376|144221200|EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the GMC of IgG antibody at one month following third vaccination was within this equivalence interval for serotype 19A, Lot 1 and Lot 3 would be equivalent with respect to the immune response to the vaccine lot|Pn IgG type 19A GMC Ratio|0.88|||||TWO_SIDED|95.0|0.79|0.98||||||The 3 lots were to be considered equivalent if, for each serotype, all 3 CIs for IgG GMC ratios 4 weeks after the primary vaccination series lay within the interval (0.5, 2)||0.98|0.79|
72350091|NCT03197376|144221200|EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the GMC of IgG antibody at one month following third vaccination was within this equivalence interval for serotype 19F, Lot 1 and Lot 3 would be equivalent with respect to the immune response to the vaccine lot|Pn IgG type 19F GMC Ratio|1.08|||||TWO_SIDED|95.0|0.97|1.2||||||The 3 lots were to be considered equivalent if, for each serotype, all 3 CIs for IgG GMC ratios 4 weeks after the primary vaccination series lay within the interval (0.5, 2)||1.20|0.97|
72350092|NCT03197376|144221200|EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the GMC of IgG antibody at one month following third vaccination was within this equivalence interval for serotype 24F, Lot 1 and Lot 3 would be equivalent with respect to the immune response to the vaccine lot|Pn IgG type 23F GMC Ratio|1.03|||||TWO_SIDED|95.0|0.92|1.15||||||The 3 lots were to be considered equivalent if, for each serotype, all 3 CIs for IgG GMC ratios 4 weeks after the primary vaccination series lay within the interval (0.5, 2)||1.15|0.92|
72350093|NCT03197376|144221200|EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the GMC of IgG antibody at one month following third vaccination was within this equivalence interval for serotype 1, Lot 2 and Lot 3 would be equivalent with respect to the immune response to the vaccine lot|Pn IgG type 1 GMC Ratio|0.93|||||TWO_SIDED|95.0|0.85|1.01||||||The 3 lots were to be considered equivalent if, for each serotype, all 3 CIs for IgG GMC ratios 4 weeks after the primary vaccination series lay within the interval (0.5, 2)||1.01|0.85|
72350094|NCT03197376|144221200|EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the GMC of IgG antibody at one month following third vaccination was within this equivalence interval for serotype 5, Lot 2 and Lot 3 would be equivalent with respect to the immune response to the vaccine lot|Pn IgG type 5 GMC Ratio|0.98|||||TWO_SIDED|95.0|0.9|1.07||||||The 3 lots were to be considered equivalent if, for each serotype, all 3 CIs for IgG GMC ratios 4 weeks after the primary vaccination series lay within the interval (0.5, 2)||1.07|0.90|
72429178|NCT01009047|144369353|SUPERIORITY_OR_OTHER||LS mean difference|0.6|STANDARD_ERROR_OF_MEAN|1.66||0.705|TWO_SIDED|95.0|-2.64|3.89||Change at Day 182: Analysis of covariance (ANCOVA) model with treatment groups (paliperidone ER, aripiprazole) and country as factors, and baseline value as a covariate was used.|ANCOVA|||||3.89|-2.64|0.705
72429179|NCT01009047|144369354|SUPERIORITY_OR_OTHER|||||||0.119||||||Day 56: Generalized Cochran-Mantel-Haenszel test for row mean score differences was used.|Cochran-Mantel-Haenszel|||||||0.119
72429180|NCT01009047|144369354|SUPERIORITY_OR_OTHER|||||||0.444||||||Day 182: Generalized Cochran-Mantel-Haenszel test for row mean score differences was used.|Cochran-Mantel-Haenszel|||||||0.444
72350095|NCT03197376|144221200|EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the GMC of IgG antibody at one month following third vaccination was within this equivalence interval for serotype 6A, Lot 2 and Lot 3 would be equivalent with respect to the immune response to the vaccine lot|Pn IgG type 6A GMC Ratio|0.95|||||TWO_SIDED|95.0|0.82|1.09||||||The 3 lots were to be considered equivalent if, for each serotype, all 3 CIs for IgG GMC ratios 4 weeks after the primary vaccination series lay within the interval (0.5, 2)||1.09|0.82|
72350096|NCT03197376|144221200|EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the GMC of IgG antibody at one month following third vaccination was within this equivalence interval for serotype 6B, Lot 2 and Lot 3 would be equivalent with respect to the immune response to the vaccine lot|Pn IgG type 6B GMC Ratio|0.62|||||TWO_SIDED|95.0|0.52|0.74||||||The 3 lots were to be considered equivalent if, for each serotype, all 3 CIs for IgG GMC ratios 4 weeks after the primary vaccination series lay within the interval (0.5, 2)||0.74|0.52|
72350097|NCT03197376|144221200|EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the GMC of IgG antibody at one month following third vaccination was within this equivalence interval for serotype 7F, Lot 2 and Lot 3 would be equivalent with respect to the immune response to the vaccine lot|Pn IgG type 7F GMC Ratio|0.69|||||TWO_SIDED|95.0|0.62|0.76||||||The 3 lots were to be considered equivalent if, for each serotype, all 3 CIs for IgG GMC ratios 4 weeks after the primary vaccination series lay within the interval (0.5, 2)||0.76|0.62|
72350098|NCT03197376|144221200|EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the GMC of IgG antibody at one month following third vaccination was within this equivalence interval for serotype 9V, Lot 2 and Lot 3 would be equivalent with respect to the immune response to the vaccine lot|Pn IgG type 9V GMC Ratio|0.82|||||TWO_SIDED|95.0|0.74|0.9||||||The 3 lots were to be considered equivalent if, for each serotype, all 3 CIs for IgG GMC ratios 4 weeks after the primary vaccination series lay within the interval (0.5, 2)||0.90|0.74|
72350099|NCT03197376|144221200|EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the GMC of IgG antibody at one month following third vaccination was within this equivalence interval for serotype 14, Lot 2 and Lot 3 would be equivalent with respect to the immune response to the vaccine lot|Pn IgG type 14 GMC Ratio|1.02|||||TWO_SIDED|95.0|0.89|1.17||||||The 3 lots were to be considered equivalent if, for each serotype, all 3 CIs for IgG GMC ratios 4 weeks after the primary vaccination series lay within the interval (0.5, 2)||1.17|0.89|
72350100|NCT03197376|144221200|EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the GMC of IgG antibody at one month following third vaccination was within this equivalence interval for serotype 19A, Lot 2 and Lot 3 would be equivalent with respect to the immune response to the vaccine lot|Pn IgG type 19A GMC Ratio|0.95|||||TWO_SIDED|95.0|0.85|1.06||||||The 3 lots were to be considered equivalent if, for each serotype, all 3 CIs for IgG GMC ratios 4 weeks after the primary vaccination series lay within the interval (0.5, 2)||1.06|0.85|
72350101|NCT03197376|144221200|EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the GMC of IgG antibody at one month following third vaccination was within this equivalence interval for serotype 19F, Lot 2 and Lot 3 would be equivalent with respect to the immune response to the vaccine lot|Pn IgG type 19F GMC Ratio|1.29|||||TWO_SIDED|95.0|1.16|1.44||||||The 3 lots were to be considered equivalent if, for each serotype, all 3 CIs for IgG GMC ratios 4 weeks after the primary vaccination series lay within the interval (0.5, 2)||1.44|1.16|
72350102|NCT03197376|144221200|EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the GMC of IgG antibody at one month following third vaccination was within this equivalence interval for serotype 23F, Lot 2 and Lot 3 would be equivalent with respect to the immune response to the vaccine lot|Pn IgG type 23F GMC Ratio|1.0|||||TWO_SIDED|95.0|0.89|1.13||||||The 3 lots were to be considered equivalent if, for each serotype, all 3 CIs for IgG GMC ratios 4 weeks after the primary vaccination series lay within the interval (0.5, 2)||1.13|0.89|
72350103|NCT03197376|144221201|NON_INFERIORITY|Non-inferiority was to be shown if either the lower limit of the 97.5% CI for the difference in proportions of IgG responders (PNEUMOSIL-Synflorix) exceeded -10%, for 7 or more of the 10 serotypes in PNEUMOSIL|Absolute Difference for Type 1|0.7|||||TWO_SIDED|97.5|0.0|1.9||||||||1.9|-0.0|
72350104|NCT03197376|144221201|NON_INFERIORITY|Non-inferiority was to be shown if either the lower limit of the 97.5% CI for the difference in proportions of IgG responders (PNEUMOSIL-Synflorix) exceeded -10% for 7 or more of the 10 serotypes in PNEUMOSIL|Absolute Difference for Type 5|2.8|||||TWO_SIDED|97.5|1.2|5.0||||||||5.0|1.2|
72350105|NCT03197376|144221201|NON_INFERIORITY|Non-inferiority was to be shown if either the lower limit of the 97.5% CI for the difference in proportions of IgG responders (PNEUMOSIL-Synflorix) exceeded -10% for 7 or more of the 10 serotypes in PNEUMOSIL|Absolute Difference for Type 6A|5.2|||||TWO_SIDED|97.5|1.1|9.5||||||Synflorix proportion of responders for serotype 6A was operationally defined as the lowest observed proportion of responders among the 8 serotypes in common with PNEUMOSIL||9.5|1.1|
72350106|NCT03197376|144221201|NON_INFERIORITY|Non-inferiority was to be shown if either the lower limit of the 97.5% CI for the difference in proportions of IgG responders (PNEUMOSIL-Synflorix) exceeded -10% for 7 or more of the 10 serotypes in PNEUMOSIL|Absolute Difference for Type 6B|2.0|||||TWO_SIDED|97.5|-2.2|6.4||||||||6.4|-2.2|
72350107|NCT03197376|144221201|NON_INFERIORITY|Non-inferiority was to be shown if either the lower limit of the 97.5% CI for the difference in proportions of IgG responders (PNEUMOSIL-Synflorix) exceeded -10% for 7 or more of the 10 serotypes in PNEUMOSIL|Absolute Difference for Type 7F|1.0|||||TWO_SIDED|97.5|-0.1|2.7||||||||2.7|-0.1|
72350108|NCT03197376|144221201|NON_INFERIORITY|Non-inferiority was to be shown if either the lower limit of the 97.5% CI for the difference in proportions of IgG responders (PNEUMOSIL-Synflorix) exceeded -10% for 7 or more of the 10 serotypes in PNEUMOSIL|Absolute Difference for Type 9V|0.1|||||TWO_SIDED|97.5|-1.9|2.5||||||||2.5|-1.9|
72350109|NCT03197376|144221201|NON_INFERIORITY|Non-inferiority was to be shown if either the lower limit of the 97.5% CI for the difference in proportions of IgG responders (PNEUMOSIL-Synflorix) exceeded -10% for 7 or more of the 10 serotypes in PNEUMOSIL|Absolute Difference for Type 14|-0.3|||||TWO_SIDED|97.5|-1.4|1.0||||||||1.0|-1.4|
72429181|NCT03875911|144369365|EQUIVALENCE|ANOVA was used to analyze equivalence between arms||||||0.52|||||||ANOVA|||||||0.52
72429182|NCT03875911|144369366|EQUIVALENCE|Equivalence calculated using ANOVA||||||0.01|||||||ANOVA|||||||0.01
72429183|NCT03875911|144369367|EQUIVALENCE|Equivalence was assessed using ANOVA||||||0.25|||||||ANOVA|||||||0.25
72350110|NCT03197376|144221201|NON_INFERIORITY|Non-inferiority was to be shown if either the lower limit of the 97.5% CI for the difference in proportions of IgG responders (PNEUMOSIL-Synflorix) exceeded -10% for 7 or more of the 10 serotypes in PNEUMOSIL|Absolute Difference for Type 19A|18.7|||||TWO_SIDED|97.5|15.1|22.5||||||Synflorix proportion of responders for serotype 19A was operationally defined as the lowest observed proportion of responders among the 8 serotypes in common with PNEUMOSIL||22.5|15.1|
72350111|NCT03197376|144221201|NON_INFERIORITY|Non-inferiority was to be shown if either the lower limit of the 97.5% CI for the difference in proportions of IgG responders (PNEUMOSIL-Synflorix) exceeded -10% for 7 or more of the 10 serotypes in PNEUMOSIL|Absolute Difference for Type 19F|-0.8|||||TWO_SIDED|97.5|-1.9|0.5||||||||0.5|-1.9|
72350112|NCT03197376|144221201|NON_INFERIORITY|Non-inferiority was to be shown if either the lower limit of the 97.5% CI for the difference in proportions of IgG responders (PNEUMOSIL-Synflorix) exceeded -10% for 7 or more of the 10 serotypes in PNEUMOSIL|Absolute Difference for Type 23F|17.2|||||TWO_SIDED|97.5|13.6|21.1||||||||21.1|13.6|
72350113|NCT03197376|144221202|NON_INFERIORITY|Non-inferiority was to be shown if the lower limit of the 97.5% CI for the GMC ratio (PNEUMOSIL/Synflorix) exceeded 0.5, for 7 or more of the 10 serotypes in PNEUMOSIL|Pn IgG type 1 GMC Ratio|2.15|||||TWO_SIDED|97.5|2.0|2.32||||||||2.32|2.00|
72350114|NCT03197376|144221202|NON_INFERIORITY|Non-inferiority was to be shown if the lower limit of the 97.5% CI for the GMC ratio (PNEUMOSIL/Synflorix) exceeded 0.5, for 7 or more of the 10 serotypes in PNEUMOSIL|Pn IgG type 5 GMC Ratio|1.37|||||TWO_SIDED|97.5|1.28|1.47||||||||1.47|1.28|
72350115|NCT03197376|144221202|NON_INFERIORITY|Non-inferiority was to be shown if the lower limit of the 97.5% CI for the GMC ratio (PNEUMOSIL/Synflorix) exceeded 0.5, for 7 or more of the 10 serotypes in PNEUMOSIL|Pn IgG type 6A GMC Ratio|0.89|||||TWO_SIDED|97.5|0.78|1.01||||||Synflorix proportion of responders for serotype 6A was operationally defined as the lowest observed proportion of responders among the 8 serotypes in common with PNEUMOSIL||1.01|0.78|
72350116|NCT03197376|144221202|NON_INFERIORITY|Non-inferiority was to be shown if the lower limit of the 97.5% CI for the GMC ratio (PNEUMOSIL/Synflorix) exceeded 0.5, for 7 or more of the 10 serotypes in PNEUMOSIL|Pn IgG type 6B GMC Ratio|1.07|||||TWO_SIDED|97.5|0.93|1.24||||||||1.24|0.93|
72350117|NCT03197376|144221202|NON_INFERIORITY|Non-inferiority was to be shown if the lower limit of the 97.5% CI for the GMC ratio (PNEUMOSIL/Synflorix) exceeded 0.5, for 7 or more of the 10 serotypes in PNEUMOSIL|Pn IgG type 7F GMC Ratio|1.3|||||TWO_SIDED|97.5|1.19|1.41||||||||1.41|1.19|
72350118|NCT03197376|144221202|NON_INFERIORITY|Non-inferiority was to be shown if the lower limit of the 97.5% CI for the GMC ratio (PNEUMOSIL/Synflorix) exceeded 0.5, for 7 or more of the 10 serotypes in PNEUMOSIL|Pn IgG type 9V GMC Ratio|0.92|||||TWO_SIDED|97.5|0.85|1.0||||||||1.00|0.85|
72350119|NCT03197376|144221202|NON_INFERIORITY|Non-inferiority was to be shown if the lower limit of the 97.5% CI for the GMC ratio (PNEUMOSIL/Synflorix) exceeded 0.5, for 7 or more of the 10 serotypes in PNEUMOSIL|Pn IgG type 14 GMC Ratio|1.23|||||TWO_SIDED|97.5|1.1|1.37||||||||1.37|1.10|
72350120|NCT03197376|144221202|NON_INFERIORITY|Non-inferiority was to be shown if the lower limit of the 97.5% CI for the GMC ratio (PNEUMOSIL/Synflorix) exceeded 0.5, for 7 or more of the 10 serotypes in PNEUMOSIL|Pn IgG type 19A GMC Ratio|1.45|||||TWO_SIDED|97.5|1.3|1.63||||||Synflorix proportion of responders for serotype 19A was operationally defined as the lowest observed proportion of responders among the 8 serotypes in common with PNEUMOSIL||1.63|1.30|
72350121|NCT03197376|144221202|NON_INFERIORITY|Non-inferiority was to be shown if the lower limit of the 97.5% CI for the GMC ratio (PNEUMOSIL/Synflorix) exceeded 0.5, for 7 or more of the 10 serotypes in PNEUMOSIL|Pn IgG type 19F GMC Ratio|0.73|||||TWO_SIDED|97.5|0.67|0.8||||||||0.80|0.67|
72350122|NCT03197376|144221202|NON_INFERIORITY|Non-inferiority was to be shown if the lower limit of the 97.5% CI for the GMC ratio (PNEUMOSIL/Synflorix) exceeded 0.5, for 7 or more of the 10 serotypes in PNEUMOSIL|Pn IgG type 23F GMC Ratio|1.81|||||TWO_SIDED|97.5|1.63|2.01||||||||2.01|1.63|
72350123|NCT03197376|144221203|NON_INFERIORITY|Non-inferiority was to be shown if the lower limit of the 95% CI exceeded -10% (for comparisons based on the difference in proportions of antibody responders to EPI vaccines between PNEUMOSIL and Synflorix)|Absolute difference for diphtheria|0.0|||||TWO_SIDED||||||||CI could not be computed due to 100% response rate|||||
72350124|NCT03197376|144221203|NON_INFERIORITY|Non-inferiority was to be shown if the lower limit of the 95% CI exceeded -10% (for comparisons based on the difference in proportions of antibody responders to EPI vaccines between PNEUMOSIL and Synflorix)|Absolute difference for Tetanus|0.0|||||TWO_SIDED||||||||CI could not be computed due to 100% response rate|||||
72350125|NCT03197376|144221203|NON_INFERIORITY|Non-inferiority was to be shown if the lower limit of the 95% CI exceeded -10% (for comparisons based on the difference in proportions of antibody responders to EPI vaccines between PNEUMOSIL and Synflorix)|Absolute difference for Hepatitis B|0.4|||||TWO_SIDED|95.0|-0.4|2.5||||||||2.5|-0.4|
72350126|NCT03197376|144221203|NON_INFERIORITY|Non-inferiority was to be shown if the lower limit of the 95% CI exceeded -10% (for comparisons based on the difference in proportions of antibody responders to EPI vaccines between PNEUMOSIL and Synflorix)|Absolute difference for Hib|-0.9|||||TWO_SIDED|95.0|-2.5|1.2||||||||1.2|-2.5|
72350127|NCT03197376|144221203|NON_INFERIORITY|Non-inferiority was to be shown if the lower limit of the 95% CI exceeded -10% (for comparisons based on the difference in proportions of antibody responders to EPI vaccines between PNEUMOSIL and Synflorix)|Absolute difference for Polio type 1|-0.2|||||TWO_SIDED|95.0|-1.3|1.5||||||||1.5|-1.3|
72350128|NCT03197376|144221203|NON_INFERIORITY|Non-inferiority was to be shown if the lower limit of the 95% CI exceeded -10% (for comparisons based on the difference in proportions of antibody responders to EPI vaccines between PNEUMOSIL and Synflorix)|Absolute difference for Polio type 2|2.8|||||TWO_SIDED|95.0|-3.2|9.3||||||||9.3|-3.2|
72350129|NCT03197376|144221203|NON_INFERIORITY|Non-inferiority was to be shown if the lower limit of the 95% CI exceeded -10% (for comparisons based on the difference in proportions of antibody responders to EPI vaccines between PNEUMOSIL and Synflorix)|Absolute difference for Polio type 3|-0.9|||||TWO_SIDED|95.0|-3.0|1.8||||||||1.8|-3.0|
72350130|NCT03197376|144221203|NON_INFERIORITY|Non-inferiority was to be shown if the lower limit of the 95% CI exceeded -10% (for comparisons based on the difference in proportions of antibody responders to EPI vaccines between PNEUMOSIL and Synflorix)|Absolute difference for Rotavirus|0.2|||||TWO_SIDED|95.0|-7.1|7.1||||||||7.1|-7.1|
72350131|NCT03197376|144221204|NON_INFERIORITY|Non-inferiority was to be shown if the lower limit of the 95% CI for the GMC ratio exceeded 0.5 (for pertussis antigens).|GMC Ratio for anti-pertussis toxoid|0.82|||||TWO_SIDED|95.0|0.62|1.09||||||||1.09|0.62|
72429184|NCT03875911|144369368|EQUIVALENCE|Equivalence determined by ANOVA||||||0.93|||||||ANOVA|||||||0.93
72350132|NCT03197376|144221205|NON_INFERIORITY|Non-inferiority was to be shown if the lower limit of the 95% CI for the GMC ratio exceeded 0.5 (for pertussis antigens).|GMC Ratio for anti-fimbriae 2/3|0.98|||||TWO_SIDED|95.0|0.77|1.25||||||||1.25|0.77|
72350133|NCT03197376|144221212|SUPERIORITY|Proportions with IgG concentration ≥ 0.35 µg/mL will be compared using a z-test for proportions. The test will be done at the two-sided 2.5% significance level to adjust for the two superiority tests. 97.5% CIs for treatment-group differences in response, will also be reported|Difference for Type 6A|73.3|||||TWO_SIDED|97.5|69.8|76.3||||||||76.3|69.8|
72350134|NCT03197376|144221212|SUPERIORITY|Proportions with IgG concentration ≥ 0.35 µg/mL will be compared using a z-test for proportions. The test will be done at the two-sided 2.5% significance level to adjust for the two superiority tests. 97.5% CIs for treatment-group differences in response, will also be reported|Difference for Type 19A|54.7|||||TWO_SIDED|97.5|50.3|58.9||||||||58.9|50.3|
72350135|NCT03197376|144221213|SUPERIORITY|For each of the two serotypes, GMCs are compared by a two-sample t-test on the difference between means of log10 (antibody). The test was done at the two-sided 2.5% significance level to adjust for the two superiority tests. 97.5% CIs for treatment-group differences in response, are also be reported|Pn IgG type 6A GMC Ratio|8.51|||||TWO_SIDED|97.5|7.68|9.43||||||||9.43|7.68|
72350136|NCT03197376|144221213|SUPERIORITY|For each of the two serotypes, GMCs are compared by a two-sample t-test on the difference between means of log10 (antibody). The test was done at the two-sided 2.5% significance level to adjust for the two superiority tests. 97.5% CIs for treatment-group differences in response, are also be reported|Pn IgG type 19A GMC Ratio|5.64|||||TWO_SIDED|97.5|5.14|6.18||||||||6.18|5.14|
72350137|NCT03197376|144221214|OTHER|Serotype specific functional antibody responses measured by OPA titer to Pneumosil in comparison with Synflorix for each of the 10 serotypes|OPA Type 1|17.2|||||TWO_SIDED|95.0|11.0|23.6||||||||23.6|11.0|
72350138|NCT03197376|144221214|OTHER|Serotype specific functional antibody responses measured by OPA titer to Pneumosil in comparison with Synflorix for each of the 10 serotypes|OPA Type 5|2.8|||||TWO_SIDED|95.0|0.0|6.2||||||||6.2|-0.0|
72350139|NCT03197376|144221214|OTHER|Serotype specific functional antibody responses measured by OPA titer to Pneumosil in comparison with Synflorix for each of the 10 serotypes|OPA Type 6A|82.2|||||TWO_SIDED|95.0|76.7|86.6||||||||86.6|76.7|
72350140|NCT03197376|144221214|OTHER|Serotype specific functional antibody responses measured by OPA titer to Pneumosil in comparison with Synflorix for each of the 10 serotypes|OPA Type 6B|9.4|||||TWO_SIDED|95.0|4.5|14.6||||||||14.6|4.5|
72429185|NCT03875911|144369369|EQUIVALENCE|Equivalence determined by ANOVA||||||0.83|||||||ANOVA|||||||0.83
72350141|NCT03197376|144221214|OTHER|Serotype specific functional antibody responses measured by OPA titer to Pneumosil in comparison with Synflorix for each of the 10 serotypes|OPA Type 7F|0.4|||||TWO_SIDED|95.0|-1.1|2.2||||||||2.2|-1.1|
72350142|NCT03197376|144221214|OTHER|Serotype specific functional antibody responses measured by OPA titer to Pneumosil in comparison with Synflorix for each of the 10 serotypes|OPA Type 9V|0.0|||||TWO_SIDED||||||||CI could not be computed due to 100% response rate|||||
72350143|NCT03197376|144221214|OTHER|Serotype specific functional antibody responses measured by OPA titer to Pneumosil in comparison with Synflorix for each of the 10 serotypes|OPA Type14|-0.8|||||TWO_SIDED|95.0|-4.0|2.2||||||||2.2|-4.0|
72350144|NCT03197376|144221214|OTHER|Serotype specific functional antibody responses measured by OPA titer to Pneumosil in comparison with Synflorix for each of the 10 serotypes|OPA Type 19A|53.3|||||TWO_SIDED|95.0|46.0|60.1||||||||60.1|46.0|
72350145|NCT03197376|144221214|OTHER|Serotype specific functional antibody responses measured by OPA titer to Pneumosil in comparison with Synflorix for each of the 10 serotypes|OPA Type 19F|-1.6|||||TWO_SIDED|95.0|-4.9|1.2||||||||1.2|-4.9|
72350146|NCT03197376|144221214|OTHER|Serotype specific functional antibody responses measured by OPA titer to Pneumosil in comparison with Synflorix for each of the 10 serotypes|OPA Type 23F|0.0|||||TWO_SIDED||||||||CI could not be computed due to 100% response rate|||||
72350147|NCT03197376|144221215|OTHER|Serotype specific functional antibody responses measured by OPA to Pneumosil in comparison with Synflorix for each of the 10 serotypes (GMT Ratio)|OPA GMT Ratio-Type 1|3.09|||||TWO_SIDED|95.0|2.4|3.98||||||||3.98|2.40|
72350148|NCT03197376|144221215|OTHER|Serotype specific functional antibody responses measured by OPA to Pneumosil in comparison with Synflorix for each of the 10 serotypes (GMT Ratio)|OPA GMT Ratio-Type 5|1.39|||||TWO_SIDED|95.0|1.12|1.72||||||||1.72|1.12|
72350149|NCT03197376|144221215|OTHER|Serotype specific functional antibody responses measured by OPA to Pneumosil in comparison with Synflorix for each of the 10 serotypes (GMT Ratio)|OPA GMT Ratio-Type 6A|186.0|||||TWO_SIDED|95.0|144.0|241.0||||||||241|144|
72350150|NCT03197376|144221215|OTHER|Serotype specific functional antibody responses measured by OPA to Pneumosil in comparison with Synflorix for each of the 10 serotypes (GMT Ratio)|OPA GMT Ratio-Type 6B|1.95|||||TWO_SIDED|95.0|1.42|2.69||||||||2.69|1.42|
72350151|NCT03197376|144221215|OTHER|Serotype specific functional antibody responses measured by OPA to Pneumosil in comparison with Synflorix for each of the 10 serotypes (GMT Ratio)|OPA GMT Ratio-Type 7F|1.16|||||TWO_SIDED|95.0|0.96|1.39||||||||1.39|0.96|
72350152|NCT03197376|144221215|OTHER|Serotype specific functional antibody responses measured by OPA to Pneumosil in comparison with Synflorix for each of the 10 serotypes (GMT Ratio)|OPA GMT Ratio-Type 9V|0.38|||||TWO_SIDED|95.0|0.29|0.49||||||||0.49|0.29|
72350153|NCT03197376|144221215|OTHER|Serotype specific functional antibody responses measured by OPA to Pneumosil in comparison with Synflorix for each of the 10 serotypes (GMT Ratio)|OPA GMT Ratio-Type 14|0.92|||||TWO_SIDED|95.0|0.67|1.27||||||||1.27|0.67|
72350154|NCT03197376|144221215|OTHER|Serotype specific functional antibody responses measured by OPA to Pneumosil in comparison with Synflorix for each of the 10 serotypes (GMT Ratio)|OPA GMT Ratio-Type 19A|13.4|||||TWO_SIDED|95.0|10.2|17.7||||||||17.7|10.2|
72350155|NCT03197376|144221215|OTHER|Serotype specific functional antibody responses measured by OPA to Pneumosil in comparison with Synflorix for each of the 10 serotypes (GMT Ratio)|OPA GMT Ratio-Type 19F|0.66|||||TWO_SIDED|95.0|0.54|0.81||||||||0.81|0.54|
72350156|NCT03197376|144221215|OTHER|Serotype specific functional antibody responses measured by OPA to Pneumosil in comparison with Synflorix for each of the 10 serotypes (GMT Ratio)|OPA GMT Ratio-Type 23F|3.03|||||TWO_SIDED|95.0|2.25|4.09||||||||4.09|2.25|
72350157|NCT03197376|144221216|OTHER|The comparisons were based on the ratio of IgG GMC post-booster to the IgG GMC post-primary series in the Booster Cohort restricted to subjects who contributed relevant data at both time points.|Pn IgG type 1 GMC Ratio|1.41|||||TWO_SIDED|95.0|1.31|1.52||||||||1.52|1.31|
72429186|NCT03875911|144369370|EQUIVALENCE|Equivalence was determined using ANOVA||||||0.54|||||||ANOVA|||||||0.54
72350158|NCT03197376|144221216|OTHER|The comparisons were based on the ratio of IgG GMC post-booster to the IgG GMC post-primary series in the Booster Cohort restricted to subjects who contributed relevant data at both time points.|Pn IgG type 5 GMC Ratio|0.88|||||TWO_SIDED|95.0|0.81|0.95||||||||0.95|0.81|
72350159|NCT03197376|144221216|OTHER|The comparisons were based on the ratio of IgG GMC post-booster to the IgG GMC post-primary series in the Booster Cohort restricted to subjects who contributed relevant data at both time points.|Pn IgG type 6A GMC Ratio|4.46|||||TWO_SIDED|95.0|4.01|4.96||||||||4.96|4.01|
72350160|NCT03197376|144221216|OTHER|The comparisons were based on the ratio of IgG GMC post-booster to the IgG GMC post-primary series in the Booster Cohort restricted to subjects who contributed relevant data at both time points.|Pn IgG type 6B GMC Ratio|6.43|||||TWO_SIDED|95.0|5.7|7.26||||||||7.26|5.70|
72350161|NCT03197376|144221216|OTHER|The comparisons were based on the ratio of IgG GMC post-booster to the IgG GMC post-primary series in the Booster Cohort restricted to subjects who contributed relevant data at both time points.|Pn IgG type 7F GMC Ratio|2.04|||||TWO_SIDED|95.0|1.89|2.19||||||||2.19|1.89|
72350162|NCT03197376|144221216|OTHER|The comparisons were based on the ratio of IgG GMC post-booster to the IgG GMC post-primary series in the Booster Cohort restricted to subjects who contributed relevant data at both time points.|Pn IgG type 9V GMC Ratio|1.39|||||TWO_SIDED|95.0|1.29|1.5||||||||1.50|1.29|
72350163|NCT03197376|144221216|OTHER|The comparisons were based on the ratio of IgG GMC post-booster to the IgG GMC post-primary series in the Booster Cohort restricted to subjects who contributed relevant data at both time points.|Pn IgG type 14 GMC Ratio|1.35|||||TWO_SIDED|95.0|1.21|1.51||||||||1.51|1.21|
72350164|NCT03197376|144221216|OTHER|The comparisons were based on the ratio of IgG GMC post-booster to the IgG GMC post-primary series in the Booster Cohort restricted to subjects who contributed relevant data at both time points.|Pn IgG type 19A GMC Ratio|2.64|||||TWO_SIDED|95.0|2.4|2.91||||||||2.91|2.40|
72350165|NCT03197376|144221216|OTHER|The comparisons were based on the ratio of IgG GMC post-booster to the IgG GMC post-primary series in the Booster Cohort restricted to subjects who contributed relevant data at both time points.|Pn IgG type 19F GMC Ratio|1.49|||||TWO_SIDED|95.0|1.36|1.63||||||||1.63|1.36|
72350166|NCT03197376|144221216|OTHER|The comparisons were based on the ratio of IgG GMC post-booster to the IgG GMC post-primary series in the Booster Cohort restricted to subjects who contributed relevant data at both time points.|Pn IgG type 23F GMC Ratio|2.5|||||TWO_SIDED|95.0|2.29|2.72||||||||2.72|2.29|
72350167|NCT03197376|144221216|OTHER|The comparisons were based on the ratio of IgG GMC post-booster to the IgG GMC post-primary series in the Booster Cohort restricted to subjects who contributed relevant data at both time points.|Pn IgG type 1 GMC Ratio|1.17|||||TWO_SIDED|95.0|1.06|1.28||||||||1.28|1.06|
72350168|NCT03197376|144221216|OTHER|The comparisons were based on the ratio of IgG GMC post-booster to the IgG GMC post-primary series in the Booster Cohort restricted to subjects who contributed relevant data at both time points.|Pn IgG type 5 GMC Ratio|0.67|||||TWO_SIDED|95.0|0.61|0.74||||||||0.74|0.61|
72350169|NCT03197376|144221216|OTHER|The comparisons were based on the ratio of IgG GMC post-booster to the IgG GMC post-primary series in the Booster Cohort restricted to subjects who contributed relevant data at both time points.|Pn IgG type 6A GMC Ratio|3.49|||||TWO_SIDED|95.0|2.97|4.11||||||||4.11|2.97|
72350170|NCT03197376|144221216|OTHER|The comparisons were based on the ratio of IgG GMC post-booster to the IgG GMC post-primary series in the Booster Cohort restricted to subjects who contributed relevant data at both time points.|Pn IgG type 6B GMC Ratio|3.85|||||TWO_SIDED|95.0|3.23|4.59||||||||4.59|3.23|
72350171|NCT03197376|144221216|OTHER|The comparisons were based on the ratio of IgG GMC post-booster to the IgG GMC post-primary series in the Booster Cohort restricted to subjects who contributed relevant data at both time points.|Pn IgG type 7F GMC Ratio|1.63|||||TWO_SIDED|95.0|1.47|1.82||||||||1.82|1.47|
72350172|NCT03197376|144221216|OTHER|The comparisons were based on the ratio of IgG GMC post-booster to the IgG GMC post-primary series in the Booster Cohort restricted to subjects who contributed relevant data at both time points.|Pn IgG type 9V GMC Ratio|1.46|||||TWO_SIDED|95.0|1.31|1.62||||||||1.62|1.31|
72350173|NCT03197376|144221216|OTHER|The comparisons were based on the ratio of IgG GMC post-booster to the IgG GMC post-primary series in the Booster Cohort restricted to subjects who contributed relevant data at both time points.|Pn IgG type 14 GMC Ratio|1.21|||||TWO_SIDED|95.0|1.03|1.42||||||||1.42|1.03|
72350174|NCT03197376|144221216|OTHER|The comparisons were based on the ratio of IgG GMC post-booster to the IgG GMC post-primary series in the Booster Cohort restricted to subjects who contributed relevant data at both time points.|Pn IgG type 19A GMC Ratio|3.6|||||TWO_SIDED|95.0|2.99|4.33||||||||4.33|2.99|
72350175|NCT03197376|144221216|OTHER|The comparisons were based on the ratio of IgG GMC post-booster to the IgG GMC post-primary series in the Booster Cohort restricted to subjects who contributed relevant data at both time points.|Pn IgG type 19F GMC Ratio|1.55|||||TWO_SIDED|95.0|1.38|1.75||||||||1.75|1.38|
72350176|NCT03197376|144221216|OTHER|The comparisons were based on the ratio of IgG GMC post-booster to the IgG GMC post-primary series in the Booster Cohort restricted to subjects who contributed relevant data at both time points.|Pn IgG type 23F GMC Ratio|2.29|||||TWO_SIDED|95.0|1.98|2.65||||||||2.65|1.98|
72350177|NCT03197376|144221217|OTHER|The vaccines were compared using the ratios of the GMC ratios for the two treatment groups, i.e., the PNEUMOSIL ratio divided by the Synflorix ratio, and the corresponding 95% CIs based on log linear random effects models|Pn IgG type 1 GMC Ratio|2.34|||||TWO_SIDED|95.0|2.02|2.71||||||||2.71|2.02|
72350178|NCT03197376|144221217|OTHER|The vaccines were compared using the ratios of the GMC ratios for the two treatment groups, i.e., the PNEUMOSIL ratio divided by the Synflorix ratio, and the corresponding 95% CIs based on log linear random effects models|Pn IgG type 5 GMC Ratio|1.57|||||TWO_SIDED|95.0|1.38|1.79||||||||1.79|1.38|
72350179|NCT03197376|144221217|OTHER|The vaccines were compared using the ratios of the GMC ratios for the two treatment groups, i.e., the PNEUMOSIL ratio divided by the Synflorix ratio, and the corresponding 95% CIs based on log linear random effects models|Pn IgG type 6A GMC Ratio|11.6|||||TWO_SIDED|95.0|9.67|14.0||||||||14.0|9.67|
72350180|NCT03197376|144221217|OTHER|The vaccines were compared using the ratios of the GMC ratios for the two treatment groups, i.e., the PNEUMOSIL ratio divided by the Synflorix ratio, and the corresponding 95% CIs based on log linear random effects models|Pn IgG type 6B GMC Ratio|1.89|||||TWO_SIDED|95.0|1.65|2.15||||||||2.15|1.65|
72350181|NCT03197376|144221217|OTHER|The vaccines were compared using the ratios of the GMC ratios for the two treatment groups, i.e., the PNEUMOSIL ratio divided by the Synflorix ratio, and the corresponding 95% CIs based on log linear random effects models|Pn IgG type 7F GMC Ratio|1.57|||||TWO_SIDED|95.0|1.37|1.8||||||||1.80|1.37|
72350182|NCT03197376|144221217|OTHER|The vaccines were compared using the ratios of the GMC ratios for the two treatment groups, i.e., the PNEUMOSIL ratio divided by the Synflorix ratio, and the corresponding 95% CIs based on log linear random effects models|Pn IgG type 9V GMC Ratio|0.87|||||TWO_SIDED|95.0|0.76|0.99||||||||0.99|0.76|
72350183|NCT03197376|144221217|OTHER|The vaccines were compared using the ratios of the GMC ratios for the two treatment groups, i.e., the PNEUMOSIL ratio divided by the Synflorix ratio, and the corresponding 95% CIs based on log linear random effects models|Pn IgG type 14 GMC Ratio|1.48|||||TWO_SIDED|95.0|1.21|1.82||||||||1.82|1.21|
72350184|NCT03197376|144221217|OTHER|The vaccines were compared using the ratios of the GMC ratios for the two treatment groups, i.e., the PNEUMOSIL ratio divided by the Synflorix ratio, and the corresponding 95% CIs based on log linear random effects models|Pn IgG type 19A GMC Ratio|4.22|||||TWO_SIDED|95.0|3.52|5.06||||||||5.06|3.52|
72350185|NCT03197376|144221217|OTHER|The vaccines were compared using the ratios of the GMC ratios for the two treatment groups, i.e., the PNEUMOSIL ratio divided by the Synflorix ratio, and the corresponding 95% CIs based on log linear random effects models|Pn IgG type 19F GMC Ratio|0.63|||||TWO_SIDED|95.0|0.55|0.73||||||||0.73|0.55|
72350186|NCT03197376|144221217|OTHER|The vaccines were compared using the ratios of the GMC ratios for the two treatment groups, i.e., the PNEUMOSIL ratio divided by the Synflorix ratio, and the corresponding 95% CIs based on log linear random effects models|Pn IgG type 23F GMC Ratio|1.91|||||TWO_SIDED|95.0|1.63|2.24||||||||2.24|1.63|
72350187|NCT03197376|144221218|OTHER|The comparisons were based on OPA GMTs 4 weeks post primary series and 4 weeks post booster for the OPA subset of the booster cohort. It was restricted to subjects who contributed relevant data at both time points|OPA GMT Ratio-Type 1|3.47|||||TWO_SIDED|95.0|2.72|4.44||||||||4.44|2.72|
72350188|NCT03197376|144221218|OTHER|The comparisons were based on OPA GMTs 4 weeks post primary series and 4 weeks post booster for the OPA subset of the booster cohort. It was restricted to subjects who contributed relevant data at both time points|OPA GMT Ratio-Type 5|2.54|||||TWO_SIDED|95.0|2.06|3.13||||||||3.13|2.06|
72350189|NCT03197376|144221218|OTHER|The comparisons were based on OPA GMTs 4 weeks post primary series and 4 weeks post booster for the OPA subset of the booster cohort. It was restricted to subjects who contributed relevant data at both time points|OPA GMT Ratio-Type 6A|2.5|||||TWO_SIDED|95.0|1.83|3.42||||||||3.42|1.83|
72350190|NCT03197376|144221218|OTHER|The comparisons were based on OPA GMTs 4 weeks post primary series and 4 weeks post booster for the OPA subset of the booster cohort. It was restricted to subjects who contributed relevant data at both time points|OPA GMT Ratio-Type 6B|3.76|||||TWO_SIDED|95.0|2.48|5.69||||||||5.69|2.48|
72350191|NCT03197376|144221218|OTHER|The comparisons were based on OPA GMTs 4 weeks post primary series and 4 weeks post booster for the OPA subset of the booster cohort. It was restricted to subjects who contributed relevant data at both time points|OPA GMT Ratio-Type 7F|3.89|||||TWO_SIDED|95.0|2.92|5.18||||||||5.18|2.92|
72350192|NCT03197376|144221218|OTHER|The comparisons were based on OPA GMTs 4 weeks post primary series and 4 weeks post booster for the OPA subset of the booster cohort. It was restricted to subjects who contributed relevant data at both time points|OPA GMT Ratio-Type 9V|6.85|||||TWO_SIDED|95.0|4.45|10.52||||||||10.52|4.45|
72350193|NCT03197376|144221218|OTHER|The comparisons were based on OPA GMTs 4 weeks post primary series and 4 weeks post booster for the OPA subset of the booster cohort. It was restricted to subjects who contributed relevant data at both time points|OPA GMT Ratio-Type 14|2.45|||||TWO_SIDED|95.0|1.64|3.65||||||||3.65|1.64|
72350194|NCT03197376|144221218|OTHER|The comparisons were based on OPA GMTs 4 weeks post primary series and 4 weeks post booster for the OPA subset of the booster cohort. It was restricted to subjects who contributed relevant data at both time points|OPA GMT Ratio-Type 19A|3.64|||||TWO_SIDED|95.0|2.47|5.36||||||||5.36|2.47|
72350195|NCT03197376|144221218|OTHER|The comparisons were based on OPA GMTs 4 weeks post primary series and 4 weeks post booster for the OPA subset of the booster cohort. It was restricted to subjects who contributed relevant data at both time points|OPA GMT Ratio-Type 19F|2.38|||||TWO_SIDED|95.0|1.8|3.14||||||||3.14|1.80|
72350196|NCT03197376|144221218|OTHER|The comparisons were based on OPA GMTs 4 weeks post primary series and 4 weeks post booster for the OPA subset of the booster cohort. It was restricted to subjects who contributed relevant data at both time points|OPA GMT Ratio-Type 23F|4.97|||||TWO_SIDED|95.0|3.49|7.06||||||||7.06|3.49|
72350197|NCT03197376|144221218|OTHER|The comparisons were based on OPA GMTs 4 weeks post primary series and 4 weeks post booster for the OPA subset of the booster cohort. It was restricted to subjects who contributed relevant data at both time points|OPA GMT Ratio-Type 1|6.29|||||TWO_SIDED|95.0|4.97|7.96||||||||7.96|4.97|
72350198|NCT03197376|144221218|OTHER|The comparisons were based on OPA GMTs 4 weeks post primary series and 4 weeks post booster for the OPA subset of the booster cohort. It was restricted to subjects who contributed relevant data at both time points|OPA GMT Ratio-Type 5|3.19|||||TWO_SIDED|95.0|2.56|3.98||||||||3.98|2.56|
72350199|NCT03197376|144221218|OTHER|The comparisons were based on OPA GMTs 4 weeks post primary series and 4 weeks post booster for the OPA subset of the booster cohort. It was restricted to subjects who contributed relevant data at both time points|OPA GMT Ratio-Type 6A|6.21|||||TWO_SIDED|95.0|3.55|10.84||||||||10.84|3.55|
72350200|NCT03197376|144221218|OTHER|The comparisons were based on OPA GMTs 4 weeks post primary series and 4 weeks post booster for the OPA subset of the booster cohort. It was restricted to subjects who contributed relevant data at both time points|OPA GMT Ratio-Type 6B|3.25|||||TWO_SIDED|95.0|2.25|4.7||||||||4.70|2.25|
72350201|NCT03197376|144221218|OTHER|The comparisons were based on OPA GMTs 4 weeks post primary series and 4 weeks post booster for the OPA subset of the booster cohort. It was restricted to subjects who contributed relevant data at both time points|OPA GMT Ratio-Type 7F|2.81|||||TWO_SIDED|95.0|2.13|3.69||||||||3.69|2.13|
72350202|NCT03197376|144221218|OTHER|The comparisons were based on OPA GMTs 4 weeks post primary series and 4 weeks post booster for the OPA subset of the booster cohort. It was restricted to subjects who contributed relevant data at both time points|OPA GMT Ratio-Type 9V|2.95|||||TWO_SIDED|95.0|2.15|4.04||||||||4.04|2.15|
72429187|NCT05126459|144369379|SUPERIORITY|||||||0.016||||||The threshold for statistical significance was p=0.05.|ANOVA|||Null hypothesis: there is no significant difference in Musculo skeletal related sedation related events during sedation.||||0.016
72350203|NCT03197376|144221218|OTHER|The comparisons were based on OPA GMTs 4 weeks post primary series and 4 weeks post booster for the OPA subset of the booster cohort. It was restricted to subjects who contributed relevant data at both time points|OPA GMT Ratio-Type 14|1.62|||||TWO_SIDED|95.0|1.06|2.46||||||||2.46|1.06|
72350204|NCT03197376|144221218|OTHER|The comparisons were based on OPA GMTs 4 weeks post primary series and 4 weeks post booster for the OPA subset of the booster cohort. It was restricted to subjects who contributed relevant data at both time points|OPA GMT Ratio-Type 19A|5.98|||||TWO_SIDED|95.0|3.88|9.21||||||||9.21|3.88|
72350205|NCT03197376|144221218|OTHER|The comparisons were based on OPA GMTs 4 weeks post primary series and 4 weeks post booster for the OPA subset of the booster cohort. It was restricted to subjects who contributed relevant data at both time points|OPA GMT Ratio-Type 19F|1.97|||||TWO_SIDED|95.0|1.45|2.68||||||||2.68|1.45|
72350206|NCT03197376|144221218|OTHER|The comparisons were based on OPA GMTs 4 weeks post primary series and 4 weeks post booster for the OPA subset of the booster cohort. It was restricted to subjects who contributed relevant data at both time points|OPA GMT Ratio-Type 23F|5.73|||||TWO_SIDED|95.0|3.8|8.63||||||||8.63|3.80|
72350207|NCT03197376|144221219|OTHER|The vaccines will be compared using the ratios of the GMT ratios for the two treatment groups, i.e., the PNEUMOSIL ratio divided by the Synflorix ratio, and the corresponding 95% CIs based on log linear random effects models|OPA GMT Ratio-Type 1|1.84|||||TWO_SIDED|95.0|1.25|2.72||||||||2.72|1.25|
72350208|NCT03197376|144221219|OTHER|The vaccines will be compared using the ratios of the GMT ratios for the two treatment groups, i.e., the PNEUMOSIL ratio divided by the Synflorix ratio, and the corresponding 95% CIs based on log linear random effects models|OPA GMT Ratio-Type 5|1.14|||||TWO_SIDED|95.0|0.79|1.64||||||||1.64|0.79|
72350209|NCT03197376|144221219|OTHER|The vaccines will be compared using the ratios of the GMT ratios for the two treatment groups, i.e., the PNEUMOSIL ratio divided by the Synflorix ratio, and the corresponding 95% CIs based on log linear random effects models|OPA GMT Ratio-Type 6A|68.1|||||TWO_SIDED|95.0|37.07|125.09||||||||125.09|37.07|
72350210|NCT03197376|144221219|OTHER|The vaccines will be compared using the ratios of the GMT ratios for the two treatment groups, i.e., the PNEUMOSIL ratio divided by the Synflorix ratio, and the corresponding 95% CIs based on log linear random effects models|OPA GMT Ratio-Type 6B|1.75|||||TWO_SIDED|95.0|1.25|2.46||||||||2.46|1.25|
72350211|NCT03197376|144221219|OTHER|The vaccines will be compared using the ratios of the GMT ratios for the two treatment groups, i.e., the PNEUMOSIL ratio divided by the Synflorix ratio, and the corresponding 95% CIs based on log linear random effects models|OPA GMT Ratio-Type 7F|1.73|||||TWO_SIDED|95.0|1.28|2.34||||||||2.34|1.28|
72350212|NCT03197376|144221219|OTHER|The vaccines will be compared using the ratios of the GMT ratios for the two treatment groups, i.e., the PNEUMOSIL ratio divided by the Synflorix ratio, and the corresponding 95% CIs based on log linear random effects models|OPA GMT Ratio-Type 9V|0.93|||||TWO_SIDED|95.0|0.65|1.32||||||||1.32|0.65|
72350213|NCT03197376|144221219|OTHER|The vaccines will be compared using the ratios of the GMT ratios for the two treatment groups, i.e., the PNEUMOSIL ratio divided by the Synflorix ratio, and the corresponding 95% CIs based on log linear random effects models|OPA GMT Ratio-Type 14|2.21|||||TWO_SIDED|95.0|1.38|3.51||||||||3.51|1.38|
72350214|NCT03197376|144221219|OTHER|The vaccines will be compared using the ratios of the GMT ratios for the two treatment groups, i.e., the PNEUMOSIL ratio divided by the Synflorix ratio, and the corresponding 95% CIs based on log linear random effects models|OPA GMT Ratio-Type 19A|12.54|||||TWO_SIDED|95.0|7.36|21.37||||||||21.37|7.36|
72350215|NCT03197376|144221219|OTHER|The vaccines will be compared using the ratios of the GMT ratios for the two treatment groups, i.e., the PNEUMOSIL ratio divided by the Synflorix ratio, and the corresponding 95% CIs based on log linear random effects models|OPA GMT Ratio-Type 19F|1.01|||||TWO_SIDED|95.0|0.7|1.46||||||||1.46|0.70|
72350216|NCT03197376|144221219|OTHER|The vaccines will be compared using the ratios of the GMT ratios for the two treatment groups, i.e., the PNEUMOSIL ratio divided by the Synflorix ratio, and the corresponding 95% CIs based on log linear random effects models|OPA GMT Ratio-Type 23F|3.14|||||TWO_SIDED|95.0|2.21|4.45||||||||4.45|2.21|
72350217|NCT03197376|144221220|NON_INFERIORITY|Non-inferiority will be shown if a two-sided 95% CI for the treatment-group difference in response proportions (proportion with Synflorix co-administration minus proportion with PNEUMOSIL co-administration) has an upper limit of \< 0.10.|Absolute difference for measles|1.7|||||TWO_SIDED|95.0|-3.3|7.4||||||||7.4|-3.3|
72350218|NCT03197376|144221220|NON_INFERIORITY|Non-inferiority will be shown if a two-sided 95% CI for the treatment-group difference in response proportions (proportion with Synflorix co-administration minus proportion with PNEUMOSIL co-administration) has an upper limit of \< 0.10.|Absolute difference for rubella|1.0|||||TWO_SIDED|95.0|-0.9|4.0||||||||4.0|-0.9|
72350219|NCT03197376|144221220|NON_INFERIORITY|Non-inferiority will be shown if a two-sided 95% CI for the treatment-group difference in response proportions (proportion with Synflorix co-administration minus proportion with PNEUMOSIL co-administration) has an upper limit of \< 0.10.|Absolute difference for yellow fever|2.4|||||TWO_SIDED|95.0|0.2|5.9||||||||5.9|0.2|
72350220|NCT03197376|144221221|OTHER|Treatment group difference in proportions|Absolute Difference for Type 1|16.2|||||TWO_SIDED|95.0|8.0|23.7||||||||23.7|8.0|
72350221|NCT03197376|144221221|OTHER|Treatment group difference in proportions|Absolute Difference for Type 5|7.2|||||TWO_SIDED|95.0|-1.4|15.8||||||||15.8|-1.4|
72350222|NCT03197376|144221221|OTHER|Treatment group difference in proportions|Absolute Difference for Type 6A|30.0|||||TWO_SIDED|95.0|21.8|38.1||||||||38.1|21.8|
72350223|NCT03197376|144221221|OTHER|Treatment group difference in proportions|Absolute Difference for Type 6B|16.5|||||TWO_SIDED|95.0|10.1|23.6||||||||23.6|10.1|
72350224|NCT03197376|144221221|OTHER|Treatment group difference in proportions|Absolute Difference for Type 7F|16.4|||||TWO_SIDED|95.0|8.4|24.5||||||||24.5|8.4|
72350225|NCT03197376|144221221|OTHER|Treatment group difference in proportions|Absolute Difference for Type 9V|-0.2|||||TWO_SIDED|95.0|-8.8|8.5||||||||8.5|-8.8|
72350226|NCT03197376|144221221|OTHER|Treatment group difference in proportions|Absolute Difference for Type 14|14.7|||||TWO_SIDED|95.0|7.5|22.3||||||||22.3|7.5|
72350227|NCT03197376|144221221|OTHER|Treatment group difference in proportions|Absolute Difference for Type 19A|14.7|||||TWO_SIDED|95.0|7.3|22.5||||||||22.5|7.3|
72350228|NCT03197376|144221221|OTHER|Treatment group difference in proportions|Absolute Difference for Type 19F|-13.7|||||TWO_SIDED|95.0|-19.0|-8.0||||||||-8.0|-19.0|
72350229|NCT03197376|144221221|OTHER|Treatment group difference in proportions|Absolute Difference for Type 23F|16.9|||||TWO_SIDED|95.0|8.2|25.4||||||||25.4|8.2|
72350230|NCT03197376|144221222|OTHER|The vaccines were compared using the ratios of the GMC ratios for the two treatment groups, i.e., the PNEUMOSIL ratio divided by the Synflorix ratio, and the corresponding 95% CIs|Pn IgG type 1 GMC Ratio|1.64|||||TWO_SIDED|95.0|1.42|1.89||||||||1.89|1.42|
72350231|NCT03197376|144221222|OTHER|The vaccines were compared using the ratios of the GMC ratios for the two treatment groups, i.e., the PNEUMOSIL ratio divided by the Synflorix ratio, and the corresponding 95% CIs|Pn IgG type 5 GMC Ratio|1.2|||||TWO_SIDED|95.0|1.03|1.4||||||||1.40|1.03|
72350232|NCT03197376|144221222|OTHER|The vaccines were compared using the ratios of the GMC ratios for the two treatment groups, i.e., the PNEUMOSIL ratio divided by the Synflorix ratio, and the corresponding 95% CIs|Pn IgG type 6A GMC Ratio|2.36|||||TWO_SIDED|95.0|2.01|2.78||||||||2.78|2.01|
72350233|NCT03197376|144221222|OTHER|The vaccines were compared using the ratios of the GMC ratios for the two treatment groups, i.e., the PNEUMOSIL ratio divided by the Synflorix ratio, and the corresponding 95% CIs|Pn IgG type 6B GMC Ratio|1.45|||||TWO_SIDED|95.0|1.27|1.66||||||||1.66|1.27|
72350234|NCT03197376|144221222|OTHER|The vaccines were compared using the ratios of the GMC ratios for the two treatment groups, i.e., the PNEUMOSIL ratio divided by the Synflorix ratio, and the corresponding 95% CIs|Pn IgG type 7F GMC Ratio|1.29|||||TWO_SIDED|95.0|1.12|1.49||||||||1.49|1.12|
72350235|NCT03197376|144221222|OTHER|The vaccines were compared using the ratios of the GMC ratios for the two treatment groups, i.e., the PNEUMOSIL ratio divided by the Synflorix ratio, and the corresponding 95% CIs|Pn IgG type 9V GMC Ratio|0.94|||||TWO_SIDED|95.0|0.81|1.09||||||||1.09|0.81|
72350236|NCT03197376|144221222|OTHER|The vaccines were compared using the ratios of the GMC ratios for the two treatment groups, i.e., the PNEUMOSIL ratio divided by the Synflorix ratio, and the corresponding 95% CIs|Pn IgG type 14 GMC Ratio|1.41|||||TWO_SIDED|95.0|1.15|1.72||||||||1.72|1.15|
72350237|NCT03197376|144221222|OTHER|The vaccines were compared using the ratios of the GMC ratios for the two treatment groups, i.e., the PNEUMOSIL ratio divided by the Synflorix ratio, and the corresponding 95% CIs|Pn IgG type 19A GMC Ratio|1.38|||||TWO_SIDED|95.0|1.14|1.68||||||||1.68|1.14|
72350238|NCT03197376|144221222|OTHER|The vaccines were compared using the ratios of the GMC ratios for the two treatment groups, i.e., the PNEUMOSIL ratio divided by the Synflorix ratio, and the corresponding 95% CIs|Pn IgG type 19F GMC Ratio|0.61|||||TWO_SIDED|95.0|0.5|0.74||||||||0.74|0.50|
72350239|NCT03197376|144221222|OTHER|The vaccines were compared using the ratios of the GMC ratios for the two treatment groups, i.e., the PNEUMOSIL ratio divided by the Synflorix ratio, and the corresponding 95% CIs|Pn IgG type 23F GMC Ratio|1.5|||||TWO_SIDED|95.0|1.24|1.81||||||||1.81|1.24|
72350240|NCT03197376|144221223|OTHER|The comparisons were based on the ratio of IgG GMC one year post-booster to the IgG GMC 4 weeks post booster in the Booster Cohort.|Pn IgG type 1 GMC Ratio|0.05|||||TWO_SIDED|95.0|0.05|0.06||||||||0.06|0.05|
72350241|NCT03197376|144221223|OTHER|The comparisons were based on the ratio of IgG GMC one year post-booster to the IgG GMC 4 weeks post booster in the Booster Cohort.|Pn IgG type 5 GMC Ratio|0.3|||||TWO_SIDED|95.0|0.27|0.33||||||||0.33|0.27|
72350242|NCT03197376|144221223|OTHER|The comparisons were based on the ratio of IgG GMC one year post-booster to the IgG GMC 4 weeks post booster in the Booster Cohort.|Pn IgG type 6A GMC Ratio|0.15|||||TWO_SIDED|95.0|0.13|0.16||||||||0.16|0.13|
72350243|NCT03197376|144221223|OTHER|The comparisons were based on the ratio of IgG GMC one year post-booster to the IgG GMC 4 weeks post booster in the Booster Cohort.|Pn IgG type 6B GMC Ratio|0.11|||||TWO_SIDED|95.0|0.1|0.11||||||||0.11|0.10|
72350244|NCT03197376|144221223|OTHER|The comparisons were based on the ratio of IgG GMC one year post-booster to the IgG GMC 4 weeks post booster in the Booster Cohort.|Pn IgG type 7F GMC Ratio|0.1|||||TWO_SIDED|95.0|0.09|0.11||||||||0.11|0.09|
72350245|NCT03197376|144221223|OTHER|The comparisons were based on the ratio of IgG GMC one year post-booster to the IgG GMC 4 weeks post booster in the Booster Cohort.|Pn IgG type 9V GMC Ratio|0.21|||||TWO_SIDED|95.0|0.19|0.23||||||||0.23|0.19|
72350246|NCT03197376|144221223|OTHER|The comparisons were based on the ratio of IgG GMC one year post-booster to the IgG GMC 4 weeks post booster in the Booster Cohort.|Pn IgG type 14 GMC Ratio|0.15|||||TWO_SIDED|95.0|0.13|0.17||||||||0.17|0.13|
72350247|NCT03197376|144221223|OTHER|The comparisons were based on the ratio of IgG GMC one year post-booster to the IgG GMC 4 weeks post booster in the Booster Cohort.|Pn IgG type 19A GMC Ratio|0.23|||||TWO_SIDED|95.0|0.2|0.26||||||||0.26|0.20|
72350248|NCT03197376|144221223|OTHER|The comparisons were based on the ratio of IgG GMC one year post-booster to the IgG GMC 4 weeks post booster in the Booster Cohort.|Pn IgG type 19F GMC Ratio|0.14|||||TWO_SIDED|95.0|0.12|0.15||||||||0.15|0.12|
72350249|NCT03197376|144221223|OTHER|The comparisons were based on the ratio of IgG GMC one year post-booster to the IgG GMC 4 weeks post booster in the Booster Cohort.|Pn IgG type 23F GMC Ratio|0.11|||||TWO_SIDED|95.0|0.1|0.12||||||||0.12|0.10|
72350250|NCT03197376|144221223|OTHER|The comparisons were based on the ratio of IgG GMC one year post-booster to the IgG GMC 4 weeks post booster in the Booster Cohort.|Pn IgG type 1 GMC Ratio|0.07|||||TWO_SIDED|95.0|0.06|0.08||||||||0.08|0.06|
72350251|NCT03197376|144221223|OTHER|The comparisons were based on the ratio of IgG GMC one year post-booster to the IgG GMC 4 weeks post booster in the Booster Cohort.|Pn IgG type 5 GMC Ratio|0.4|||||TWO_SIDED|95.0|0.35|0.45||||||||0.45|0.35|
72350252|NCT03197376|144221223|OTHER|The comparisons were based on the ratio of IgG GMC one year post-booster to the IgG GMC 4 weeks post booster in the Booster Cohort.|Pn IgG type 6A GMC Ratio|0.73|||||TWO_SIDED|95.0|0.62|0.86||||||||0.86|0.62|
72350253|NCT03197376|144221223|OTHER|The comparisons were based on the ratio of IgG GMC one year post-booster to the IgG GMC 4 weeks post booster in the Booster Cohort.|Pn IgG type 6B GMC Ratio|0.14|||||TWO_SIDED|95.0|0.12|0.16||||||||0.16|0.12|
72350254|NCT03197376|144221223|OTHER|The comparisons were based on the ratio of IgG GMC one year post-booster to the IgG GMC 4 weeks post booster in the Booster Cohort.|Pn IgG type 7F GMC Ratio|0.12|||||TWO_SIDED|95.0|0.11|0.13||||||||0.13|0.11|
72350255|NCT03197376|144221223|OTHER|The comparisons were based on the ratio of IgG GMC one year post-booster to the IgG GMC 4 weeks post booster in the Booster Cohort.|Pn IgG type 9V GMC Ratio|0.2|||||TWO_SIDED|95.0|0.18|0.22||||||||0.22|0.18|
72350256|NCT03197376|144221223|OTHER|The comparisons were based on the ratio of IgG GMC one year post-booster to the IgG GMC 4 weeks post booster in the Booster Cohort.|Pn IgG type 14 GMC Ratio|0.15|||||TWO_SIDED|95.0|0.13|0.19||||||||0.19|0.13|
72350257|NCT03197376|144221223|OTHER|The comparisons were based on the ratio of IgG GMC one year post-booster to the IgG GMC 4 weeks post booster in the Booster Cohort.|Pn IgG type 19A GMC Ratio|0.64|||||TWO_SIDED|95.0|0.52|0.78||||||||0.78|0.52|
72350258|NCT03197376|144221223|OTHER|The comparisons were based on the ratio of IgG GMC one year post-booster to the IgG GMC 4 weeks post booster in the Booster Cohort.|Pn IgG type 19F GMC Ratio|0.14|||||TWO_SIDED|95.0|0.12|0.16||||||||0.16|0.12|
72350259|NCT03197376|144221223|OTHER|The comparisons were based on the ratio of IgG GMC one year post-booster to the IgG GMC 4 weeks post booster in the Booster Cohort.|Pn IgG type 23F GMC Ratio|0.14|||||TWO_SIDED|95.0|0.12|0.16||||||||0.16|0.12|
72350260|NCT03197376|144221224|OTHER|Serotype specific functional antibody responses measured by OPA titer to Pneumosil in comparison with Synflorix for each of the 10 serotypes one year post booster|OPA Type 1|24.2|||||TWO_SIDED|95.0|4.5|42.1||||||||42.1|4.5|
72350261|NCT03197376|144221224|OTHER|Serotype specific functional antibody responses measured by OPA titer to Pneumosil in comparison with Synflorix for each of the 10 serotypes one year post booster|OPA Type 5|9.9|||||TWO_SIDED|95.0|-5.8|25.5||||||||25.5|-5.8|
72350262|NCT03197376|144221224|OTHER|Serotype specific functional antibody responses measured by OPA titer to Pneumosil in comparison with Synflorix for each of the 10 serotypes one year post booster|OPA Type 6A|65.6|||||TWO_SIDED|95.0|48.3|78.0||||||||78.0|48.3|
72350263|NCT03197376|144221224|OTHER|Serotype specific functional antibody responses measured by OPA titer to Pneumosil in comparison with Synflorix for each of the 10 serotypes one year post booster|OPA Type 6B|23.2|||||TWO_SIDED|95.0|6.4|39.4||||||||39.4|6.4|
72350264|NCT03197376|144221224|OTHER|Serotype specific functional antibody responses measured by OPA titer to Pneumosil in comparison with Synflorix for each of the 10 serotypes one year post booster|OPA Type 7F|2.0|||||TWO_SIDED|95.0|-5.2|10.8||||||||10.8|-5.2|
72350265|NCT03197376|144221224|OTHER|Serotype specific functional antibody responses measured by OPA titer to Pneumosil in comparison with Synflorix for each of the 10 serotypes one year post booster|OPA Type 9V|0.0|||||TWO_SIDED||||||||CI could not be computed due to 100% response rate|||||
72350266|NCT03197376|144221224|OTHER|Serotype specific functional antibody responses measured by OPA titer to Pneumosil in comparison with Synflorix for each of the 10 serotypes one year post booster|OPA Type14|4.6|||||TWO_SIDED|95.0|-8.5|18.3||||||||18.3|-8.5|
72350267|NCT03197376|144221224|OTHER|Serotype specific functional antibody responses measured by OPA titer to Pneumosil in comparison with Synflorix for each of the 10 serotypes one year post booster|OPA Type 19A|34.4|||||TWO_SIDED|95.0|16.5|50.8||||||||50.8|16.5|
72350268|NCT03197376|144221224|OTHER|Serotype specific functional antibody responses measured by OPA titer to Pneumosil in comparison with Synflorix for each of the 10 serotypes one year post booster|OPA Type 19F|5.0|||||TWO_SIDED|95.0|-8.4|19.2||||||||19.2|-8.4|
72350269|NCT03197376|144221224|OTHER|Serotype specific functional antibody responses measured by OPA titer to Pneumosil in comparison with Synflorix for each of the 10 serotypes one year post booster|OPA Type 23F|0.0|||||TWO_SIDED||||||||CI could not be computed due to 100% response rate|||||
72350270|NCT03197376|144221225|OTHER|Serotype specific functional antibody responses measured by OPA to Pneumosil in comparison with Synflorix for each of the 10 serotypes (GMT Ratio) one year post booster dose|OPA GMT Ratio-Type 1|1.3|||||TWO_SIDED|95.0|0.8|2.1||||||||2.1|0.8|
72350271|NCT03197376|144221225|OTHER|Serotype specific functional antibody responses measured by OPA to Pneumosil in comparison with Synflorix for each of the 10 serotypes (GMT Ratio) one year post booster dose|OPA GMT Ratio-Type 5|1.3|||||TWO_SIDED|95.0|0.7|2.4||||||||2.4|0.7|
72350272|NCT03197376|144221225|OTHER|Serotype specific functional antibody responses measured by OPA to Pneumosil in comparison with Synflorix for each of the 10 serotypes (GMT Ratio) one year post booster dose|OPA GMT Ratio-Type 6A|14.3|||||TWO_SIDED|95.0|6.3|32.1||||||||32.1|6.3|
72350273|NCT03197376|144221225|OTHER|Serotype specific functional antibody responses measured by OPA to Pneumosil in comparison with Synflorix for each of the 10 serotypes (GMT Ratio) one year post booster dose|OPA GMT Ratio-Type 6B|3.7|||||TWO_SIDED|95.0|2.1|6.8||||||||6.8|2.1|
72350274|NCT03197376|144221225|OTHER|Serotype specific functional antibody responses measured by OPA to Pneumosil in comparison with Synflorix for each of the 10 serotypes (GMT Ratio) one year post booster dose|OPA GMT Ratio-Type 7F|1.0|||||TWO_SIDED|95.0|0.6|1.6||||||||1.6|0.6|
72350275|NCT03197376|144221225|OTHER|Serotype specific functional antibody responses measured by OPA to Pneumosil in comparison with Synflorix for each of the 10 serotypes (GMT Ratio) one year post booster dose|OPA GMT Ratio-Type 9V|0.7|||||TWO_SIDED|95.0|0.3|1.7||||||||1.7|0.3|
72350276|NCT03197376|144221225|OTHER|Serotype specific functional antibody responses measured by OPA to Pneumosil in comparison with Synflorix for each of the 10 serotypes (GMT Ratio) one year post booster dose|OPA GMT Ratio-Type 14|1.1|||||TWO_SIDED|95.0|0.5|2.4||||||||2.4|0.5|
72350277|NCT03197376|144221225|OTHER|Serotype specific functional antibody responses measured by OPA to Pneumosil in comparison with Synflorix for each of the 10 serotypes (GMT Ratio) one year post booster dose|OPA GMT Ratio-Type 19A|5.1|||||TWO_SIDED|95.0|2.4|10.8||||||||10.8|2.4|
72350278|NCT03197376|144221225|OTHER|Serotype specific functional antibody responses measured by OPA to Pneumosil in comparison with Synflorix for each of the 10 serotypes (GMT Ratio) one year post booster dose|OPA GMT Ratio-Type 19F|1.0|||||TWO_SIDED|95.0|0.4|2.3||||||||2.3|0.4|
72350279|NCT03197376|144221225|OTHER|Serotype specific functional antibody responses measured by OPA to Pneumosil in comparison with Synflorix for each of the 10 serotypes (GMT Ratio) one year post booster dose|OPA GMT Ratio-Type 23F|4.3|||||TWO_SIDED|95.0|2.0|9.4||||||||9.4|2.0|
72350280|NCT03197376|144221226|OTHER|The comparisons were based on OPA GMTs 4 weeks post booster and one year post booster for the OPA subset of the booster cohort.|OPA GMT Ratio-Type 1|0.04|||||TWO_SIDED|95.0|0.03|0.06||||||||0.06|0.03|
72350281|NCT03197376|144221226|OTHER|The comparisons were based on OPA GMTs 4 weeks post booster and one year post booster for the OPA subset of the booster cohort.|OPA GMT Ratio-Type 5|0.11|||||TWO_SIDED|95.0|0.09|0.14||||||||0.14|0.09|
72350282|NCT03197376|144221226|OTHER|The comparisons were based on OPA GMTs 4 weeks post booster and one year post booster for the OPA subset of the booster cohort.|OPA GMT Ratio-Type 6A|0.05|||||TWO_SIDED|95.0|0.03|0.08||||||||0.08|0.03|
72350283|NCT03197376|144221226|OTHER|The comparisons were based on OPA GMTs 4 weeks post booster and one year post booster for the OPA subset of the booster cohort.|OPA GMT Ratio-Type 6B|0.05|||||TWO_SIDED|95.0|0.03|0.07||||||||0.07|0.03|
72350284|NCT03197376|144221226|OTHER|The comparisons were based on OPA GMTs 4 weeks post booster and one year post booster for the OPA subset of the booster cohort.|OPA GMT Ratio-Type 7F|0.26|||||TWO_SIDED|95.0|0.18|0.38||||||||0.38|0.18|
72350285|NCT03197376|144221226|OTHER|The comparisons were based on OPA GMTs 4 weeks post booster and one year post booster for the OPA subset of the booster cohort.|OPA GMT Ratio-Type 9V|0.12|||||TWO_SIDED|95.0|0.06|0.23||||||||0.23|0.06|
72350286|NCT03197376|144221226|OTHER|The comparisons were based on OPA GMTs 4 weeks post booster and one year post booster for the OPA subset of the booster cohort.|OPA GMT Ratio-Type 14|0.07|||||TWO_SIDED|95.0|0.05|0.11||||||||0.11|0.05|
72350287|NCT03197376|144221226|OTHER|The comparisons were based on OPA GMTs 4 weeks post booster and one year post booster for the OPA subset of the booster cohort.|OPA GMT Ratio-Type 19A|0.16|||||TWO_SIDED|95.0|0.09|0.3||||||||0.30|0.09|
72350288|NCT03197376|144221226|OTHER|The comparisons were based on OPA GMTs 4 weeks post booster and one year post booster for the OPA subset of the booster cohort.|OPA GMT Ratio-Type 19F|0.09|||||TWO_SIDED|95.0|0.05|0.18||||||||0.18|0.05|
72350289|NCT03197376|144221226|OTHER|The comparisons were based on OPA GMTs 4 weeks post booster and one year post booster for the OPA subset of the booster cohort.|OPA GMT Ratio-Type 23F|0.12|||||TWO_SIDED|95.0|0.08|0.18||||||||0.18|0.08|
72350290|NCT03197376|144221226|OTHER|The comparisons were based on OPA GMTs 4 weeks post booster and one year post booster for the OPA subset of the booster cohort.|OPA GMT Ratio-Type 1|0.04|||||TWO_SIDED|95.0|0.03|0.06||||||||0.06|0.03|
72350291|NCT03197376|144221226|OTHER|The comparisons were based on OPA GMTs 4 weeks post booster and one year post booster for the OPA subset of the booster cohort.|OPA GMT Ratio-Type 5|0.07|||||TWO_SIDED|95.0|0.05|0.1||||||||0.10|0.05|
72350292|NCT03197376|144221226|OTHER|The comparisons were based on OPA GMTs 4 weeks post booster and one year post booster for the OPA subset of the booster cohort.|OPA GMT Ratio-Type 6A|0.21|||||TWO_SIDED|95.0|0.09|0.48||||||||0.48|0.09|
72350293|NCT03197376|144221226|OTHER|The comparisons were based on OPA GMTs 4 weeks post booster and one year post booster for the OPA subset of the booster cohort.|OPA GMT Ratio-Type 6B|0.02|||||TWO_SIDED|95.0|0.01|0.03||||||||0.03|0.01|
72350294|NCT03197376|144221226|OTHER|The comparisons were based on OPA GMTs 4 weeks post booster and one year post booster for the OPA subset of the booster cohort.|OPA GMT Ratio-Type 7F|0.44|||||TWO_SIDED|95.0|0.3|0.65||||||||0.65|0.30|
72350295|NCT03197376|144221226|OTHER|The comparisons were based on OPA GMTs 4 weeks post booster and one year post booster for the OPA subset of the booster cohort.|OPA GMT Ratio-Type 9V|0.11|||||TWO_SIDED|95.0|0.06|0.2||||||||0.20|0.06|
72350296|NCT03197376|144221226|OTHER|The comparisons were based on OPA GMTs 4 weeks post booster and one year post booster for the OPA subset of the booster cohort.|OPA GMT Ratio-Type 14|0.11|||||TWO_SIDED|95.0|0.06|0.22||||||||0.22|0.06|
72350297|NCT03197376|144221226|OTHER|The comparisons were based on OPA GMTs 4 weeks post booster and one year post booster for the OPA subset of the booster cohort.|OPA GMT Ratio-Type 19A|0.26|||||TWO_SIDED|95.0|0.14|0.49||||||||0.49|0.14|
72350298|NCT03197376|144221226|OTHER|The comparisons were based on OPA GMTs 4 weeks post booster and one year post booster for the OPA subset of the booster cohort.|OPA GMT Ratio-Type 19F|0.09|||||TWO_SIDED|95.0|0.06|0.14||||||||0.14|0.06|
72350299|NCT03197376|144221226|OTHER|The comparisons were based on OPA GMTs 4 weeks post booster and one year post booster for the OPA subset of the booster cohort.|OPA GMT Ratio-Type 23F|0.07|||||TWO_SIDED|95.0|0.05|0.12||||||||0.12|0.05|
72350300|NCT01223183|144221232|EQUIVALENCE|alpha=0.05|||||<|0.001|||||||t-test, 2 sided|||Comparing DTPA absorption after hypertonic saline inhalation to DTPA absorption after isotonic saline inhalation||||<0.001
72350301|NCT01223183|144221234|EQUIVALENCE|alpha=0.05||||||0.003|||||||t-test, 2 sided|||Comparing mucociliary clearance after isotonic saline inhalation to mucociliary clearance after hypertonic saline inhalation||||0.003
72350302|NCT00412893|144221241|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The upper bound of the 95% CI for the treatment difference was compared to the protocol prespecified non-inferiority margin of 10%. If the upper bound was smaller than 10%, isavuconazole was declared as non-inferior to voriconazole with respect to the primary outcome measure.|Adjusted Treatment Difference|-1.0|||||TWO_SIDED|95.0|-7.759|5.683|||||The treatment difference (isavuconazole minus voriconazole) was calculated using a stratified Cochran-Mantel-Haenszel (CMH) method. The strata included Geographical Regions, Allogeneic BMT Status and Uncontrolled Malignancy Status.|Approximately 255 patients per group were to be enrolled to ensure at least 80% power to demonstrate that the upper bound of the 95% confidence interval (CI) for a treatment difference in favor of the comparator was no larger than 10%.||5.683|-7.759|
72350303|NCT00412893|144221242|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Treatment Difference|1.6|||||TWO_SIDED|95.0|-9.336|12.572|||||The adjusted treatment difference (Voriconazole-Isavuconazole) was calculated by a stratified CMH method with the strata of Geographical Region, Allogeneic BMT Status and Uncontrolled Malignancy Status.|End of Treatment comparison||12.572|-9.336|
72350304|NCT00412893|144221242|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Treatment Difference|-0.5|||||TWO_SIDED|95.0|-11.277|10.329|||||The adjusted treatment difference (Voriconazole-Isavuconazole) was calculated by a stratified CMH method with the strata of Geographical Region, Allogeneic BMT Status and Uncontrolled Malignancy Status.|Day 42 comparison||10.329|-11.277|
72350305|NCT00412893|144221242|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Treatment Difference|8.2|||||TWO_SIDED|95.0|-1.993|18.379|||||The adjusted treatment difference (Voriconazole-Isavuconazole) was calculated by a stratified CMH method with the strata of Geographical Region, Allogeneic BMT Status and Uncontrolled Malignancy Status.|Day 84 comparison||18.379|-1.993|
72350306|NCT00412893|144221243|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Treatment Difference|-1.4|||||TWO_SIDED|95.0|-9.15|6.34|||||The treatment difference (isavuconazole minus voriconazole) was calculated using a stratified Cochran-Mantel-Haenszel (CMH) method. The strata included Geographical Regions, Allogeneic BMT Status and Uncontrolled Malignancy Status.|||6.340|-9.150|
72350307|NCT00412893|144221245|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Treatment Difference|0.4|||||TWO_SIDED|95.0|-10.64|11.531|||||The adjusted treatment difference (Voriconazole-Isavuconazole) was calculated by a stratified CMH method with the strata of Geographical Region, Allogeneic BMT Status and Uncontrolled Malignancy Status.|End of Treatment Comparison||11.531|-10.640|
72350308|NCT00412893|144221245|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Treatment Difference|-5.8|||||TWO_SIDED|95.0|-17.368|5.802|||||The adjusted treatment difference (Voriconazole-Isavuconazole) was calculated by a stratified CMH method with the strata of Geographical Region, Allogeneic BMT Status and Uncontrolled Malignancy Status.|Day 42 comparison||5.802|-17.368|
72350309|NCT00412893|144221245|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Treatment Difference|0.3|||||TWO_SIDED|95.0|-11.116|11.758|||||The adjusted treatment difference (Voriconazole-Isavuconazole) was calculated by a stratified CMH method with the strata of Geographical Region, Allogeneic BMT Status and Uncontrolled Malignancy Status.|Day 84 comparison||11.758|-11.116|
72429188|NCT05126459|144369380|SUPERIORITY|||||||0.211||||||The threshold for statistical significance was p=0.05.|ANOVA|||Null hypothesis: there is no significant difference in Musculo skeletal related sedation related events at 8 hours after sedation.||||0.211
72350310|NCT00412893|144221246|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Treatment Difference|3.8|||||TWO_SIDED|95.0|-7.429|15.087|||||The adjusted treatment difference (Voriconazole-Isavuconazole) was calculated by a stratified CMH method with the strata of Geographical Region, Allogeneic BMT Status and Uncontrolled Malignancy Status.|End of Treatment comparison||15.087|-7.429|
72350311|NCT00412893|144221246|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Treatment Difference|-0.7|||||TWO_SIDED|95.0|-11.917|10.586|||||The adjusted treatment difference (Voriconazole-Isavuconazole) was calculated by a stratified CMH method with the strata of Geographical Region, Allogeneic BMT Status and Uncontrolled Malignancy Status.|Day 42 Comparison||10.586|-11.917|
72350312|NCT00412893|144221246|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Treatment Difference|9.1|||||TWO_SIDED|95.0|-1.624|19.83|||||The adjusted treatment difference (Voriconazole-Isavuconazole) was calculated by a stratified CMH method with the strata of Geographical Region, Allogeneic BMT Status and Uncontrolled Malignancy Status.|Day 84 Comparison||19.830|-1.624|
72350313|NCT00412893|144221247|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Treatment Difference|5.7|||||TWO_SIDED|95.0|-4.936|16.268|||||The adjusted treatment difference (Voriconazole-Isavuconazole) was calculated by a stratified CMH method with the strata of Geographical Region, Allogeneic BMT Status and Uncontrolled Malignancy Status.|End of Treatment comparison||16.268|-4.936|
72350314|NCT00412893|144221247|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Treatment Difference|5.3|||||TWO_SIDED|95.0|-5.338|16.032|||||The adjusted treatment difference (Voriconazole-Isavuconazole) was calculated by a stratified CMH method with the strata of Geographical Region, Allogeneic BMT Status and Uncontrolled Malignancy Status.|Day 42 comparison||16.032|-5.338|
72350315|NCT00412893|144221247|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Treatment Difference|9.0|||||TWO_SIDED|95.0|-1.231|19.186|||||The adjusted treatment difference (Voriconazole-Isavuconazole) was calculated by a stratified CMH method with the strata of Geographical Region, Allogeneic BMT Status and Uncontrolled Malignancy Status.|Day 84 comparison||19.186|-1.231|
72350316|NCT00412893|144221248|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Treatment Difference|5.0|||||TWO_SIDED|95.0|-6.043|16.026|||||The adjusted treatment difference (Voriconazole-Isavuconazole) was calculated by a stratified CMH method with the strata of Geographical Region, Allogeneic BMT Status and Uncontrolled Malignancy Status.|End of Treatment comparison||16.026|-6.043|
72350317|NCT00412893|144221248|SUPERIORITY_OR_OTHER_LEGACY||Adjusted treatment Difference|0.2|||||TWO_SIDED|95.0|-10.873|11.22|||||The adjusted treatment difference (Voriconazole-Isavuconazole) was calculated by a stratified CMH method with the strata of Geographical Region, Allogeneic BMT Status and Uncontrolled Malignancy Status.|Day 42 comparison||11.220|-10.873|
72350318|NCT00412893|144221248|SUPERIORITY_OR_OTHER_LEGACY||Adjusted treatment Difference|4.7|||||TWO_SIDED|95.0|-6.533|15.939|||||The adjusted treatment difference (Voriconazole-Isavuconazole) was calculated by a stratified CMH method with the strata of Geographical Region, Allogeneic BMT Status and Uncontrolled Malignancy Status.|Day 84 comparison||15.939|-6.533|
72350319|NCT00412893|144221249|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Treatment Difference|4.4|||||TWO_SIDED|95.0|-8.429|17.218|||||The adjusted treatment difference (Voriconazole-Isavuconazole) was calculated by a stratified CMH method with the strata of Geographical Region, Allogeneic BMT Status and Uncontrolled Malignancy Status.|End of Treatment comparison||17.218|-8.429|
72350320|NCT00412893|144221249|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Treatment Difference|-2.5|||||TWO_SIDED|95.0|-15.071|10.073|||||The adjusted treatment difference (Voriconazole-Isavuconazole) was calculated by a stratified CMH method with the strata of Geographical Region, Allogeneic BMT Status and Uncontrolled Malignancy Status.|Day 42 comparison||10.073|-15.071|
72350321|NCT00412893|144221249|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Treatment Difference|2.9|||||TWO_SIDED|95.0|-8.633|14.499|||||The adjusted treatment difference (Voriconazole-Isavuconazole) was calculated by a stratified CMH method with the strata of Geographical Region, Allogeneic BMT Status and Uncontrolled Malignancy Status.|Day 84 comparison||14.499|-8.633|
72429189|NCT05126459|144369381|SUPERIORITY|||||||0.374||||||The threshold for statistical significance was p=0.05.|ANOVA|||||||0.374
72429190|NCT05126459|144369382|SUPERIORITY|||||||0.55|||||||ANOVA|||Null hypothesis: there is no significant difference in GI reaction between the 3 regimens.||||0.55
72350322|NCT00412893|144221250|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Treatment Difference|6.3|||||TWO_SIDED|95.0|-5.145|17.696|||||The adjusted treatment difference (Voriconazole-Isavuconazole) was calculated by a stratified CMH method with the strata of Geographical Region, Allogeneic BMT Status and Uncontrolled Malignancy Status.|End of Treatment comparison||17.696|-5.145|
72350323|NCT00412893|144221250|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Treatment Difference|8.0|||||TWO_SIDED|95.0|-3.335|19.356|||||The adjusted treatment difference (Voriconazole-Isavuconazole) was calculated by a stratified CMH method with the strata of Geographical Region, Allogeneic BMT Status and Uncontrolled Malignancy Status.|Day 42 comparison||19.356|-3.335|
72350324|NCT00412893|144221250|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Treatment Difference|5.1|||||TWO_SIDED|95.0|-6.187|16.332|||||The adjusted treatment difference (Voriconazole-Isavuconazole) was calculated by a stratified CMH method with the strata of Geographical Region, Allogeneic BMT Status and Uncontrolled Malignancy Status.|Day 84 comparison||16.332|-6.187|
72350325|NCT04473963|144221253|NON_INFERIORITY|Non-inferiority between subjects Randomized to Treatment vs subjects Randomized to Control||||||0.277|||||||Chi-squared|||||||0.277
72350326|NCT04473963|144221255|EQUIVALENCE|"Equivalence between subjects Randomized to Control and subjects Randomized to Treatment"||||||0.042|||||||Kaplan-Meyer Log Rank|||||||0.042
72350327|NCT04473963|144221260|EQUIVALENCE|"Equivalence between procedure time of subjects Randomized to Treatment and subjects Randomized to Control. The Not-Randomized group was not included in the analysis."|||||<|0.001|||||||t-test, 2 sided|||||||<0.001
72350328|NCT00587158|144221268|SUPERIORITY_OR_OTHER|||||||0.0005||95.0|||||Fisher Exact|||||||0.0005
72350329|NCT00587158|144221269|SUPERIORITY_OR_OTHER|||||||0.4571||95.0|||||Fisher Exact|||||||0.4571
72429191|NCT05126459|144369383|SUPERIORITY|||||||0.16||||||The threshold for statistical significance was p=0.05.|ANOVA|||Null hypothesis: there is no significant difference in GI reaction between the 3 regimens 8 hours after sedation.||||0.16
72350330|NCT00587158|144221270|SUPERIORITY_OR_OTHER|||||||0.229||95.0|||||Fisher Exact|||||||0.2290
72350331|NCT00587158|144221271|SUPERIORITY_OR_OTHER|||||||0.17||95.0|||||Wilcoxon (Mann-Whitney)|||The median PTH level at baseline was compared between the two treatment groups.||||0.17
72429192|NCT05126459|144369384|SUPERIORITY|||||||0.012||||||The threshold for statistical significance was p=0.05.|ANOVA|||Null hypothesis: there is no significant difference in GI reaction between the 3 regimens at 24 hours after sedation.||||0.012
72350332|NCT00587158|144221271|SUPERIORITY_OR_OTHER|||||||0.005||95.0|||||Wilcoxon (Mann-Whitney)|||The median PTH level at 21 days was compared between the two treatment groups.||||0.005
72350333|NCT00587158|144221271|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon (Mann-Whitney)|||The median PTH level at 90 days was compared between the two treatment groups.||||<0.0001
72350334|NCT00587158|144221271|SUPERIORITY_OR_OTHER|||||||0.0004||95.0|||||Wilcoxon (Mann-Whitney)|||The median PTH level at one year was compared between the two treatment groups.||||0.0004
72350335|NCT00587158|144221272|SUPERIORITY_OR_OTHER|||||||0.833||95.0|||||Wilcoxon (Mann-Whitney)|||The median BAP level at baseline was compared between the two treatment groups.||||0.833
72350336|NCT00587158|144221272|SUPERIORITY_OR_OTHER|||||||0.553||95.0|||||Wilcoxon (Mann-Whitney)|||The median BAP level at 21 days was compared between the two treatment groups.||||0.553
72350337|NCT00587158|144221272|SUPERIORITY_OR_OTHER|||||||0.035||95.0|||||Wilcoxon (Mann-Whitney)|||The median BAP level at 90 days was compared between the two treatment groups.||||0.035
72350338|NCT00587158|144221272|SUPERIORITY_OR_OTHER|||||||0.171||95.0|||||Wilcoxon (Mann-Whitney)|||The median BAP level at one year was compared between the two treatment groups.||||0.171
72350339|NCT00587158|144221273|SUPERIORITY_OR_OTHER|||||||0.98||95.0|||||t-test, 2 sided|||||||0.98
72350340|NCT00587158|144221274|SUPERIORITY_OR_OTHER|||||||0.41||95.0|||||t-test, 2 sided|||||||0.41
72350341|NCT00587158|144221277|SUPERIORITY_OR_OTHER|||||||0.66||95.0|||||t-test, 2 sided|||||||0.66
72350342|NCT00587158|144221278|SUPERIORITY_OR_OTHER|||||||0.66||95.0|||||t-test, 2 sided|||||||0.66
72350343|NCT00587158|144221279|SUPERIORITY_OR_OTHER|||||||0.11||95.0|||||t-test, 2 sided|||||||0.11
72350344|NCT00587158|144221280|SUPERIORITY_OR_OTHER|||||||1||95.0|||||t-test, 2 sided|||The number of subjects with mild interstitial fibrosis (Banff ci score \> 0 and \< 2) at one year was compared between treatment groups.||||1.0
72350345|NCT00587158|144221280|SUPERIORITY_OR_OTHER|||||||0.04||95.0|||||t-test, 2 sided|||The number of subjects with moderate to mild interstitial fibrosis (Banff ci score greater than or equal to 2) at one year was compared between treatment groups.||||0.04
72350346|NCT02114606|144221282|OTHER|Overall agreement was calculated using Cohen's Kappa, with endoscopic biopsy as the gold standard.||||||0.0001||||||A p-value of \<0.05 was considered statistically significant.|Cohen's Kappa|||All participants enrolled (EoE Patients) provided both a Cytosponge specimen and endoscopic biopsy. The results of these specimens were compared to examine overall agreement.||||0.0001
72350347|NCT03187119|144221287|SUPERIORITY||Slope|1.41||||0.42|TWO_SIDED|||||The results listed here are for the main effect of time. Please see Analyses 2 and 3 for the main effect of group and the time x group interaction.|linear mixed model|||The reference group for this model is the Pictorial Asthma Action Plan Group.||||0.42
72350348|NCT03187119|144221287|SUPERIORITY||Slope|-14.31||||0.03|TWO_SIDED|||||The results listed here are for the main effect of group. Please see Analyses 1 and 3 for the main effect of time and the time x group interaction.|multiple linear regression.|||The reference group for this analysis is the Pictorial Asthma Action Plan group.||||0.03
72350349|NCT03187119|144221287|SUPERIORITY||Slope|-0.33||||0.89|TWO_SIDED|||||The results listed here are for the time x group interaction. Please see Analyses 1 and 2 for the main effects of group and time.|multiple linear regression.|||The reference group for this analysis is the Pictorial Asthma Action Plan group.||||0.89
72350350|NCT03187119|144221288|SUPERIORITY||Slope|-1.59||||0.31|TWO_SIDED|||||The results listed here are for the main effect of time. Please see Analyses 2 and 3 for the main effect of group and the time x group interaction.|multiple linear regression.|||The reference group for this analysis is the Pictorial Asthma Action Plan group.||||0.31
72350351|NCT03187119|144221288|SUPERIORITY||Slope|1.9||||0.73|TWO_SIDED|||||The results listed here are for the main effect of group. Please see Analyses 1 and 3 for the main effect of time and the time x group interaction.|multiple linear regression.|||The reference for group for this analysis is the Pictorial Asthma Action Plan group.||||0.73
72350352|NCT03187119|144221288|SUPERIORITY||Slope|-0.21||||0.92|TWO_SIDED|||||The results listed here are for the time x group interaction. Please see Analyses 1 and 2 for the main effects of group and time.|multiple linear regression.|||The reference for group for this analysis is the Pictorial Asthma Action Plan group.||||0.92
72350353|NCT03187119|144221289|SUPERIORITY||Slope|0.52||||0.06|TWO_SIDED|||||The results listed here are for the main effect of time. Please see Analyses 2 and 3 for the main effect of group and the time x group interaction.|generalized linear mixed model|||The reference for group for this analysis is the Pictorial Asthma Action Plan group.||||0.06
72350354|NCT03187119|144221289|SUPERIORITY||Slope|-1.57||||0.07|TWO_SIDED|||||The results listed here are for the main effect of group. Please see Analyses 1 and 2 for the main effect of group and the time x group interaction.|generalized linear mixed model|||The reference for group for this analysis is the Pictorial Asthma Action Plan group.||||0.07
72350355|NCT03187119|144221289|SUPERIORITY||Slope|0.37||||0.33|TWO_SIDED|||||The results listed here are for the time x group interaction. Please see Analyses 2 and 3 for the main effects of group and time.|generalized linear mixed model|||The reference for group for this analysis is the Pictorial Asthma Action Plan group.||||0.33
72350356|NCT03187119|144221290|SUPERIORITY||Slope|-0.01||||0.002|TWO_SIDED|||||The results listed here are for the main effect of time. Please see Analyses 2-3 for the main effects of time and prescription and Analyses 4-6 for interactions.|generalized linear mixed model||The analyses are modeling lower adherence.|The reference group for this analysis is the Pictorial Asthma Action Plan group.||||.002
72350357|NCT03187119|144221290|SUPERIORITY||Slope|-0.16||||0.07|TWO_SIDED|||||The results listed here are for the main effect of group. Please see Analyses 1 and 3 for the main effects of time and prescription and Analyses 4-6 for interactions.|generalized linear mixed model||The analyses are modeling lower adherence.|The reference group for this analysis is the Pictorial Asthma Action Plan group.||||0.07
72350358|NCT03187119|144221290|SUPERIORITY||Slope|0.43||||0.69|TWO_SIDED|||||The results listed here are for the main effect of prescription. Please see Analyses 1-2 for the main effects of time and group and Analyses 4-6 for interactions.|generalized linear mixed model||The analyses are modeling lower adherence.|The reference group for this analysis is the Pictorial Asthma Action Plan group.||||.69
72429193|NCT02571439|144369388|OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
72429194|NCT02571439|144369389|OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
72429195|NCT02571439|144369390|OTHER|||||||0.61|||||||Kruskal-Wallis|||||||0.61
72429196|NCT02571439|144369391|OTHER|||||||0.46|||||||Kruskal-Wallis|||||||0.46
72350359|NCT03187119|144221290|SUPERIORITY||Slope|0.02||||0.37|TWO_SIDED|||||The results listed here are for the time x group interaction. Please see Analyses 1-3 for the main effects of group, time and prescription and Analyses 5-7 for other interactions.|generalized linear mixed model||The analyses are modeling lower adherence.|The reference group for this analysis is the Pictorial Asthma Action Plan group.||||0.37
72350360|NCT03187119|144221290|SUPERIORITY||Slope|-1.14||||0.12|TWO_SIDED|||||The results listed here are for the prescription x group interaction. Please see Analyses 1-3 for the main effects of group, time and prescription and Analyses 4 and 6 for other interactions.|generalized linear mixed model||The analyses are modeling lower adherence.|The reference group for this analysis is the Pictorial Asthma Action Plan group.||||0.12
72350361|NCT03187119|144221290|SUPERIORITY||Slope|0.01||||0.006|TWO_SIDED|||||The results listed here are for the time x PAAP group x prescription interaction. Please see Analyses 1-3 for the main effects of group, time and prescription and Analyses 4-5 for interactions.|generalized linear mixed model||The analyses are modeling lower adherence.|The reference groups for this analysis is the 2x per day group.||||0.006
72350362|NCT03187119|144221290|SUPERIORITY||Slope|0.04||||0.006|TWO_SIDED|||||The results listed here are for the time x WAAP group x prescription interaction. Please see Analyses 1-3 for the main effects of group, time and prescription and Analyses 4-5 for interactions.|generalized linear mixed model||These analyses are modeling lower adherence.|The reference group for this analysis is 2x per day group.||||0.006
72350363|NCT03187119|144221291|SUPERIORITY||Slope|0.08||||0.18|TWO_SIDED|||||The results listed here are for the main effect of time. Please see Analyses 2 and 3 for the main effect of group and the time x group interaction.|multiple linear regression.|||The reference for group for this analysis is the Pictorial Asthma Action Plan group.||||0.18
72350364|NCT03187119|144221291|SUPERIORITY||Slope|-0.09||||0.71|TWO_SIDED|||||The results listed here are for the main effect of group. Please see Analyses 1 and 3 for the main effect of time and the time x group interaction.|multiple linear regression.|||The reference for group for this analysis is the Pictorial Asthma Action Plan group.||||0.71
72350365|NCT03187119|144221291|SUPERIORITY||Slope|0.007||||0.96|TWO_SIDED|||||The results listed here are for the time x group interaction. Please see Analyses 1 and 2 for the main effects of time and group.|multiple linear regression.|||The reference for group for this analysis is the Pictorial Asthma Action Plan group.||||0.96
72350366|NCT03187119|144221293|SUPERIORITY||Slope|-0.02||||0.74|TWO_SIDED|||||The results listed here are for the main effect of time. Please see Analyses 2 and 3 for the main effect of group and the time x group interaction.|multiple linear regression.|||The reference for group for this analysis is the Pictorial Asthma Action Plan group.||||0.74
72350367|NCT03187119|144221293|SUPERIORITY||Slope|0.02||||0.83|TWO_SIDED|||||The results listed here are for the main effect of group. Please see Analyses 1 and 3 for the main effect of time and the time x group interaction|multiple linear regression.|||The reference for group for this analysis is the Pictorial Asthma Action Plan group.||||0.83
72350368|NCT03187119|144221293|SUPERIORITY||Slope|-0.21||||0.03|TWO_SIDED|||||The results listed here are for the time x group interaction. Please see Analyses 1 and 2 for the main effects of time and group.|multiple linear regression.|||The reference for group for this analysis is the Pictorial Asthma Action Plan group.||||0.03
72350369|NCT03187119|144221294|SUPERIORITY||Slope|0.12||||0.08|TWO_SIDED|||||The results listed here are for the main effect of time. Please see Analyses 2 and 3 for the main effect of group and the time x group interaction.|multiple linear regression.|||The reference for group for this analysis is the Pictorial Asthma Action Plan group.||||0.08
72350370|NCT03187119|144221294|SUPERIORITY||Slope|-0.12||||0.25|TWO_SIDED|||||The results listed here are for the main effect of group. Please see Analyses 1 and 3 for the main effect of time and the time x group interaction.|multiple linear regression.|||The reference for group for this analysis is the Pictorial Asthma Action Plan group.||||0.25
72429197|NCT02571439|144369392|OTHER|||||||0.33|||||||Kruskal-Wallis|||||||0.33
72350371|NCT03187119|144221294|SUPERIORITY||Slope|-0.21||||0.03|TWO_SIDED|||||The results listed here are for the time x group interaction. Please see Analyses 1 and 2 for the main effects of time and group.|multiple linear regression.|||The reference for group for this analysis is the Pictorial Asthma Action Plan group.||||0.03
72350372|NCT01466127|144221307|SUPERIORITY_OR_OTHER|||||||0.28|||||||t-test, 2 sided|||||||0.28
72350373|NCT01910402|144221308|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Hypothesis was to show that the antiviral effect of the DTG/ABC/3TC FDC administered QD was non-inferior to QD ATV+RTV+TDF/FTC FDC. Non-inferiority was concluded if the lower bound of a two-sided 95% confidence interval for the difference in response rates between the two treatment arms was greater than -12%|Adjusted difference in proportion|10.5||||0.005|TWO_SIDED|95.0|3.1|17.8||If the primary and PP analyses both demonstrated non-inferiority, then as per pre-specified analysis, superiority of DTG/ABC/3TC FDC versus ATV+RTV+TDF/FTC FDC was tested in the ITT-E population at the 2-sided 5% level of significance.|Cochran-Mantel-Haenszel|||||17.8|3.1|0.005
72350374|NCT01910402|144221330|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.026||||0.7053|TWO_SIDED|95.0|-0.159|0.107|||Multiple Imputed Dataset - MAR|||||0.107|-0.159|0.7053
72350375|NCT01910402|144221331|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.106||||0.3165|TWO_SIDED|95.0|-0.313|0.101|||Multiple Imputed Dataset - MAR|||||0.101|-0.313|0.3165
72350376|NCT01910402|144221346|SUPERIORITY_OR_OTHER_LEGACY||Ratio of ratio|0.729|||<|0.001|TWO_SIDED|95.0|0.683|0.779|||ANCOVA||BSAP ratio of Week 48 result over Baseline|||0.779|0.683|<0.001
72350377|NCT01910402|144221346|SUPERIORITY_OR_OTHER_LEGACY||Ratio of ratio|0.693|||<|0.001|TWO_SIDED|95.0|0.647|0.741|||ANCOVA||PTP ratio of Week 48 result over Baseline|||0.741|0.647|<0.001
72350378|NCT01910402|144221346|SUPERIORITY_OR_OTHER_LEGACY||Ratio of ratio|0.629|||<|0.001|TWO_SIDED|95.0|0.581|0.68|||ANCOVA||Osteocalcin ratio of Week 48 result over Baseline|||0.680|0.581|<0.001
72350379|NCT01910402|144221346|SUPERIORITY_OR_OTHER_LEGACY||Ratio of ratio|0.655|||<|0.0001|TWO_SIDED|95.0|0.609|0.706|||ANCOVA||Type 1 Collagen C-Telopeptide ratio of Week 48 result over Baseline|||0.706|0.609|<0.0001
72350380|NCT01910402|144221346|SUPERIORITY_OR_OTHER_LEGACY||Ratio of ratio|0.852|||<|0.0001|TWO_SIDED|95.0|0.794|0.914|||ANCOVA||Vitamin D ratio of Week 48 result over Baseline|||0.914|0.794|<0.0001
72350381|NCT01910402|144221348|SUPERIORITY_OR_OTHER_LEGACY|||||||0.016||95.0||||Week 4|Wilcoxon (Mann-Whitney)|||||||0.016
72350382|NCT01910402|144221348|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||Week 12|Wilcoxon (Mann-Whitney)|||||||<0.001
72429198|NCT02571439|144369393|OTHER|||||||0.13|||||||Kruskal-Wallis|||||||0.13
72429199|NCT02571439|144369394|OTHER|||||||0.17|||||||Kruskal-Wallis|||||||0.17
72350383|NCT01910402|144221348|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002||95.0||||Week 24|Wilcoxon (Mann-Whitney)|||||||0.002
72350384|NCT01910402|144221348|SUPERIORITY_OR_OTHER_LEGACY|||||||0.007||95.0||||Week 48|Wilcoxon (Mann-Whitney)|||||||0.007
72350385|NCT00571038|144221358|SUPERIORITY_OR_OTHER|||||||0.2417|TWO_SIDED||||||Mixed Models Analysis|||||||0.2417
72350386|NCT00571038|144221359|SUPERIORITY_OR_OTHER|||||||0.8586|TWO_SIDED||||||Mixed Models Analysis|||||||0.8586
72350387|NCT00571038|144221360|SUPERIORITY_OR_OTHER|||||||0.0432|TWO_SIDED||||||Mixed Models Analysis|||||||0.0432
72350388|NCT00571038|144221361|SUPERIORITY_OR_OTHER|||||||0.0604|TWO_SIDED||||||Mixed Models Analysis|||||||0.0604
72350389|NCT00571038|144221362|SUPERIORITY_OR_OTHER|||||||0.0438|TWO_SIDED||||||Kruskal-Wallis|||||||0.0438
72350390|NCT00571038|144221363|SUPERIORITY_OR_OTHER|||||||0.1418|TWO_SIDED||||||Kruskal-Wallis|||||||0.1418
72350391|NCT00571038|144221364|SUPERIORITY_OR_OTHER|||||||0.007|TWO_SIDED||||||Fisher Exact|Two-sided Pr \<= P||||||0.0070
72350392|NCT00571038|144221365|SUPERIORITY_OR_OTHER|||||||0.8395|TWO_SIDED||||||Kruskal-Wallis|||||||0.8395
72350393|NCT00571038|144221366|SUPERIORITY_OR_OTHER|||||||0.2194|TWO_SIDED||||||Kruskal-Wallis|||||||0.2194
72350394|NCT00571038|144221367|SUPERIORITY_OR_OTHER|||||||0.9191|TWO_SIDED||||||Kruskal-Wallis|||||||0.9191
72350395|NCT00571038|144221368|SUPERIORITY_OR_OTHER|||||||0.9633|TWO_SIDED||||||Kruskal-Wallis|||||||0.9633
72350396|NCT00571038|144221369|SUPERIORITY_OR_OTHER|||||||0.5901|TWO_SIDED||||||Kruskal-Wallis|||||||0.5901
72350397|NCT00571038|144221370|SUPERIORITY_OR_OTHER|||||||0.982|TWO_SIDED||||||Kruskal-Wallis|||||||0.9820
72350398|NCT00571038|144221371|SUPERIORITY_OR_OTHER|||||||0.3979|TWO_SIDED||||||Kruskal-Wallis|||||||0.3979
72350399|NCT00571038|144221372|SUPERIORITY_OR_OTHER|||||||0.1471|TWO_SIDED||||||Kruskal-Wallis|||||||0.1471
72350400|NCT00571038|144221373|SUPERIORITY_OR_OTHER|||||||0.6123|TWO_SIDED||||||Kruskal-Wallis|||||||0.6123
72350401|NCT00571038|144221374|SUPERIORITY_OR_OTHER|||||||0.5861|TWO_SIDED||||||Kruskal-Wallis|||||||0.5861
72350402|NCT00571038|144221375|SUPERIORITY_OR_OTHER|||||||0.4489|TWO_SIDED||||||Kruskal-Wallis|||||||0.4489
72350403|NCT00571038|144221376|SUPERIORITY_OR_OTHER|||||||0.2527|TWO_SIDED||||||Kruskal-Wallis|||||||0.2527
72350404|NCT00571038|144221377|SUPERIORITY_OR_OTHER|||||||0.7314|TWO_SIDED||||||Kruskal-Wallis|||||||0.7314
72350405|NCT00571038|144221378|SUPERIORITY_OR_OTHER|||||||0.9839|TWO_SIDED||||||Kruskal-Wallis|||||||0.9839
72350406|NCT01426958|144221404|NON_INFERIORITY_OR_EQUIVALENCE|Relative bioavailability|Geometric mean ratio|119.3|STANDARD_DEVIATION|11.5||0.1009|TWO_SIDED|90.0|112.239|126.811||P-value for ratio outside interval 0.8-1.25|ANOVA|Adjusted geometric mean ratio|The standard deviation is actually the geometric coefficient of variation|||126.811|112.239|0.1009
72350407|NCT01426958|144221404|NON_INFERIORITY_OR_EQUIVALENCE|Relative bioavailability|Geometric mean ratio|110.23|STANDARD_DEVIATION|10.9||0.0009|TWO_SIDED|90.0|103.837|117.006||P-value for ratio outside interval 0.8-1.25|ANOVA|Adjusted geometric mean ratio|The standard deviation is actually the geometric coefficient of variation|||117.006|103.837|0.0009
72350408|NCT01426958|144221404|NON_INFERIORITY_OR_EQUIVALENCE|Relative bioavailability|Geometric mean ratio|91.9|STANDARD_DEVIATION|11.6||0.0004|TWO_SIDED|90.0|86.519|97.614||P-value for ratio outside interval 0.8-1.25|ANOVA|Adjusted geometric mean ratio|The standard deviation is actually the geometric coefficient of variation|||97.614|86.519|0.0004
72350409|NCT01426958|144221405|NON_INFERIORITY_OR_EQUIVALENCE|Relative bioavailability|Geometric mean ratio|104.06|STANDARD_DEVIATION|14.2||0.0002|TWO_SIDED|90.0|96.681|112.002||P-value for ratio outside interval 0.8-1.25|ANOVA|Adjusted geometric mean ratio|The standard deviation is actually the geometric coefficient of variation|||112.002|96.681|0.0002
72350410|NCT01426958|144221405|NON_INFERIORITY_OR_EQUIVALENCE|Relative bioavailability|Geometric mean ratio|105.09|STANDARD_DEVIATION|16.1||0.0012|TWO_SIDED|90.0|96.425|114.53||P-value for ratio outside interval 0.8-1.25|ANOVA|Adjusted geometric mean ratio|The standard deviation is actually the geometric coefficient of variation|||114.530|96.425|0.0012
72350411|NCT01426958|144221405|NON_INFERIORITY_OR_EQUIVALENCE|Relative bioavailability|Geometric mean ratio|99.75|STANDARD_DEVIATION|12.8||0|TWO_SIDED|90.0|93.328|106.61||P-value for ratio outside interval 0.8-1.25|ANOVA|Adjusted geometric mean ratio|The standard deviation is actually the geometric coefficient of variation|||106.610|93.328|0.0000
72350412|NCT01426958|144221406|NON_INFERIORITY_OR_EQUIVALENCE|Relative bioavailability|Geometric mean ratio|118.56|STANDARD_DEVIATION|11.5||0.0702|TWO_SIDED|90.0|111.712|125.822||P-value for ratio outside interval 0.8-1.25|ANOVA|Adjusted geometric mean ratio|The standard deviation is actually the geometric coefficient of variation|||125.822|111.712|0.0702
72350413|NCT01426958|144221406|NON_INFERIORITY_OR_EQUIVALENCE|Relative bioavailability|Geometric mean ratio|110.76|STANDARD_DEVIATION|10.0||0.0005|TWO_SIDED|90.0|104.936|116.913||P-value for ratio outside interval 0.8-1.25|ANOVA|Adjusted geometric mean ratio|The standard deviation is actually the geometric coefficient of variation|||116.913|104.936|0.0005
72350414|NCT01426958|144221406|NON_INFERIORITY_OR_EQUIVALENCE|Relative bioavailability|Geometric mean ratio|92.46|STANDARD_DEVIATION|11.9||0.0003|TWO_SIDED|90.0|86.928|98.341||P-value for ratio outside interval 0.8-1.25|ANOVA|Adjusted geometric mean ratio|The standard deviation is actually the geometric coefficient of variation|||98.341|86.928|0.0003
72350415|NCT00080301|144221411|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.75||||0.0003||95.17|0.64|0.88||Test was stratified by 1) presence of visceral metastases in liver or lung, 2) minimum of either doxorubicin 420 mg/m2 or epirubicin 360 mg/m2, and relapse \> 6 months in adjuvant setting, and 3) prior chemotherapy for metastatic disease. (yes/no)|Log Rank|95.17% confidence interval is adjusted for the interim analysis.||Study required 615 events to achieve 90% power to detect a hazard ratio of 0.77 using a 2-sided α = 0.05 log-rank test. The analysis was a comparison between the 2 treatment arms using a 2-sided α=0.0483 log-rank test (adjusted for an interim analysis using the O'Brien Fleming spending function) to reject the null hypothesis of equality of progression free survival. The analysis was conducted when 639 events (310 in combination:329 in capecitabine) were observed from the 752 randomized patients.||0.88|0.64|.0003
72350416|NCT00080301|144221412|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|3.15|||<|0.0001||95.0|2.2|4.5|||Cochran-Mantel-Haenszel|||The study had 95 percent power to detect a significant difference in ORR if the true response rate was 32 percent in the combination arm and 20 percent in the capecitabine arm.||4.50|2.20|<.0001
72429200|NCT02571439|144369395|OTHER|||||||0.87|||||||Kruskal-Wallis|||||||0.87
72429201|NCT02571439|144369396|OTHER|||||||0.27|||||||Chi-squared|||||||0.27
72429202|NCT02571439|144369397|OTHER|||||||0.91|||||||Kruskal-Wallis|||||||0.91
72350417|NCT00080301|144221415|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.9||||0.1936||95.17|0.77|1.05||Test was stratified by presence of visceral metastases in liver or lung (y/n), minimum of either doxorubicin 420 mg/m2 or epirubicin 360 mg/m2, and relapse \> 6 months in adjuvant setting (y/n), and prior chemotherapy for metastatic disease (y/n).|Log Rank|Test was conducted at the α=0.05 level and no adjustments were performed.|Confidence Interval adjusted for interim analysis.|Study required 631 deaths to achieve 80% power to detect a Hazard ratio of 0.8 using a 2-sided α = 0.05 log rank test. The analysis was a comparison between the 2 treatment arms using a 2-sided α=0.05 log-rank test to reject the null hypothesis of equality of survival. The analysis was conducted when 639 deaths (318 in combination:321 in capecitabine) were observed from the 752 randomized patients.||1.05|0.77|0.1936
72350418|NCT00080301|144221417|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0002||95.0|||||Wei-Lachin|||There was a statistically significant difference between groups in change from baseline FBSI score favoring capecitabine. A mean change from baseline of 2.5 was considered a clinically meaningful difference (minimally important difference or MID). On-treatment mean changes in the FBSI did not reach the MID in either group.||||.0002
72350419|NCT02518971|144221418|OTHER|||||||0.345|||||||Chi-squared|||||||0.345
72350420|NCT02518971|144221419|OTHER|||||||0.378|||||||Student T-Test|||||||.378
72350421|NCT02518971|144221420|OTHER|||||||1|||||||Fisher Exact|||||||1.0
72350422|NCT02518971|144221421|OTHER|||||||0.497|||||||Fisher Exact|||||||.497
72350423|NCT02518971|144221422|OTHER|||||||0.207|||||||Student T-test|||||||.207
72350424|NCT02336230|144221424|OTHER|||||||0.0003||||||P-value was calculated from the binomial distribution under the assumption of a 0.45 success rate for the null hypothesis.|Binomial Distribution|||||||0.0003
72350425|NCT02336230|144221426|OTHER|||||||0.0032||||||P-value was from a Cochran-Mantel-Haenszel (CMH) test stratified by baseline aGVHD grade.|CHM test|||||||0.0032
72350426|NCT02524171|144221430|SUPERIORITY||Time x Condition at 6 mo.(Beta value)|-0.1|||>|0.05|TWO_SIDED|||||The threshold for statistical significance was p = 0.05|Mixed Models Analysis|Models adjusted for covariates (yielded estimated mean values of the outcome) and non-response weights based on completion of follow-up interviews.||||||>0.05
72350427|NCT02524171|144221430|SUPERIORITY||Time x Condition at 6 mo.(Beta value)|-0.88|||>|0.05|TWO_SIDED|||||The threshold for statistical significance was p = 0.05|Mixed Models Analysis|Models adjusted for covariates (yielded estimated mean values of the outcome) and non-response weights based on completion of follow-up interviews.||Per protocol analysis, which included all UC participants (n=169) and only those in the MRT condition who had received the minimum recommended dose of the intervention - i.e., Step 3 or higher of MRT (n=63)||||>0.05
72350428|NCT02524171|144221431|SUPERIORITY||Time x Condition at 6 mo.(Beta value)|0.06|||>|0.05|TWO_SIDED|||||The threshold for statistical significance was p = 0.05|Mixed Models Analysis|Models adjusted for covariates (yielded estimated mean values of the outcome) and non-response weights based on completion of follow-up interviews.||||||>0.05
72350429|NCT02524171|144221431|SUPERIORITY||Time x Condition at 6 mo.(Beta value)|0.02|||>|0.05|TWO_SIDED|||||The threshold for statistical significance was p = 0.05|Mixed Models Analysis|Models adjusted for covariates (yielded estimated mean values of the outcome) and non-response weights based on completion of follow-up interviews.||Per protocol analysis, which included all UC participants (n=169) and only those in the MRT condition who had received the minimum recommended dose of the intervention - i.e., Step 3 or higher of MRT (n=63)||||>0.05
72350430|NCT02524171|144221432|SUPERIORITY||Time x Condition at 6 mo.(Beta value)|10.98|||>|0.05|TWO_SIDED|||||The threshold for statistical significance was p = 0.05.|Mixed Models Analysis|Models adjusted for covariates (yielded estimated mean values of the outcome) and non-response weights based on completion of follow-up interviews.||||||>0.05
72350431|NCT02524171|144221432|SUPERIORITY||Time x Condition at 6 mo.(Beta value)|14.64|||>|0.05|TWO_SIDED|||||The threshold for statistical significance was p = 0.05|Mixed Models Analysis|Models adjusted for covariates (yielded estimated mean values of the outcome) and non-response weights based on completion of follow-up interviews.||Per protocol analysis, which included all UC participants (n=169) and only those in the MRT condition who had received the minimum recommended dose of the intervention - i.e., Step 3 or higher of MRT (n=63)||||>0.05
72350432|NCT02524171|144221433|SUPERIORITY||Time x Condition at 6 mo.(Beta value)|1.45|||>|0.05|TWO_SIDED|||||The threshold for statistical significance was p = 0.05|Mixed Models Analysis|Models adjusted for covariates (yielded estimated mean values of the outcome) and non-response weights based on completion of follow-up interviews||||||>0.05
72350433|NCT02524171|144221433|SUPERIORITY||Time x Condition at 6 mo.(Beta value)|1.22|||>|0.05|TWO_SIDED|||||The threshold for statistical significance was p = 0.05|Mixed Models Analysis|Models adjusted for covariates (yielded estimated mean values of the outcome) and non-response weights based on completion of follow-up interviews.||Per protocol analysis, which included all UC participants (n=169) and only those in the MRT condition who had received the minimum recommended dose of the intervention - i.e., Step 3 or higher of MRT (n=63)||||>0.05
72350434|NCT02524171|144221434|SUPERIORITY||Time x Condition at 6 mo.(Beta value)|0.04|||>|0.05|TWO_SIDED|||||The threshold for statistical significance was p = 0.05.|Mixed Models Analysis|Models adjusted for covariates (yielded estimated mean values of the outcome) and non-response weights based on completion of follow-up interviews.||||||>0.05
72350435|NCT02524171|144221434|SUPERIORITY||Time x Condition at 6 mo.(Beta value)|0.02|||>|0.05|TWO_SIDED|||||The threshold for statistical significance was p = 0.05|Mixed Models Analysis|Models adjusted for covariates (yielded estimated mean values of the outcome) and non-response weights based on completion of follow-up interviews.||Per protocol analysis, which included all UC participants (n=169) and only those in the MRT condition who had received the minimum recommended dose of the intervention - i.e., Step 3 or higher of MRT (n=63).||||>0.05
72350436|NCT02524171|144221435|SUPERIORITY||Time x Condition at 6mo.(Beta value)|0.04|||>|0.05|TWO_SIDED|||||The threshold for statistical significance was p = 0.05.|Mixed Models Analysis|Models adjusted for covariates (yielded estimated mean values of the outcome) and non-response weights based on completion of follow-up interviews.||||||>0.05
72350437|NCT02524171|144221435|SUPERIORITY||Time x Condition at 6 mo.(Beta value)|0.02|||>|0.05|TWO_SIDED|||||The threshold for statistical significance was p = 0.05|Mixed Models Analysis|Models adjusted for covariates (yielded estimated mean values of the outcome) and non-response weights based on completion of follow-up interviews.||Per protocol analysis, which included all UC participants (n=169) and only those in the MRT condition who had received the minimum recommended dose of the intervention - i.e., Step 3 or higher of MRT (n=63)||||>0.05
72350438|NCT02524171|144221436|SUPERIORITY||Time x Condition at 6 mo.(Beta value)|0.02|||>|0.05|TWO_SIDED|||||The threshold for statistical significance was p = 0.05|Mixed Models Analysis|Models adjusted for covariates (yielded estimated mean values of the outcome) and non-response weights based on completion of follow-up interviews.||||||>0.05
72350439|NCT02524171|144221436|SUPERIORITY||Time x Condition at 6 mo.(Beta value)|-0.08|||<|0.05|TWO_SIDED|||||The threshold for statistical significance was p = 0.05.|Mixed Models Analysis|Models adjusted for covariates (yielded estimated mean values of the outcome) and non-response weights based on completion of follow-up interviews.||Per protocol analysis, which included all UC participants (n=169) and only those in the MRT condition who had received the minimum recommended dose of the intervention - i.e., Step 3 or higher of MRT (n=63)||||<0.05
72350440|NCT02524171|144221437|SUPERIORITY||Time x Condition at 6 mo.(Beta value)|0.06|||<|0.05|TWO_SIDED|||||The threshold for statistical significance was p = 0.05|Mixed Models Analysis|Models adjusted for covariates (yielded estimated mean values of the outcome) and non-response weights based on completion of follow-up interviews.||||||<0.05
72350441|NCT02524171|144221437|SUPERIORITY||Time x Condition at 6 mo.(Beta value)|0.06|||>|0.05|TWO_SIDED|||||The threshold for statistical significance was p = 0.05.|Mixed Models Analysis|Models adjusted for covariates (yielded estimated mean values of the outcome) and non-response weights based on completion of follow-up interviews.||Per protocol analysis, which included all UC participants (n=169) and only those in the MRT condition who had received the minimum recommended dose of the intervention - i.e., Step 3 or higher of MRT (n=63)||||>0.05
72350442|NCT02524171|144221438|SUPERIORITY||Other[Time x Condition at 12 mo.(Beta|0.69|||>|0.05|TWO_SIDED|||||The threshold for statistical significance was p = 0.05|Mixed Models Analysis|Models adjusted for covariates (yielded estimated mean values of the outcome) and non-response weights based on completion of follow-up interviews.||||||>0.05
72350443|NCT02524171|144221438|SUPERIORITY||Other[Time x Condition at 12 mo.(Beta v|-0.89|||>|0.05|TWO_SIDED|||||The threshold for statistical significance was p = 0.05|Mixed Models Analysis|Models adjusted for covariates (yielded estimated mean values of the outcome) and non-response weights based on completion of follow-up interviews.||Per protocol analysis, which included all UC participants (n=169) and only those in the MRT condition who had received the minimum recommended dose of the intervention - i.e., Step 3 or higher of MRT (n=63)||||>0.05
72350444|NCT02524171|144221439|SUPERIORITY||Other[Time x Condition at 12 mo.(Beta v|0.07|||>|0.05|TWO_SIDED|||||The threshold for statistical significance was p = 0.05|Mixed Models Analysis|Models adjusted for covariates (yielded estimated mean values of the outcome) and non-response weights based on completion of follow-up interviews.||||||>0.05
72350445|NCT02524171|144221439|SUPERIORITY||Other[Time x Condition at 12 mo.(Beta v|0.01|||>|0.05|TWO_SIDED|||||The threshold for statistical significance was p = 0.05|Mixed Models Analysis|Models adjusted for covariates (yielded estimated mean values of the outcome) and non-response weights based on completion of follow-up interviews.||Per protocol analysis, which included all UC participants (n=169) and only those in the MRT condition who had received the minimum recommended dose of the intervention - i.e., Step 3 or higher of MRT (n=63)||||>0.05
72350446|NCT02524171|144221440|SUPERIORITY||Other[Time x Condition at 12 mo.(Beta v|6.53|||>|0.05|TWO_SIDED|||||The threshold for statistical significance was p = 0.05.|Mixed Models Analysis|Models adjusted for covariates (yielded estimated mean values of the outcome) and non-response weights based on completion of follow-up interviews.||||||>0.05
72350447|NCT02524171|144221440|SUPERIORITY||Other[Time x Condition at 12 mo.(Beta v|5.68|||>|0.05|TWO_SIDED|||||The threshold for statistical significance was p = 0.05|Mixed Models Analysis|Models adjusted for covariates (yielded estimated mean values of the outcome) and non-response weights based on completion of follow-up interviews.||Per protocol analysis, which included all UC participants (n=169) and only those in the MRT condition who had received the minimum recommended dose of the intervention - i.e., Step 3 or higher of MRT (n=63||||>0.05
72350448|NCT02524171|144221441|SUPERIORITY||Other[Time x Condition at 12 mo.(Beta v|0.83|||>|0.05|TWO_SIDED|||||The threshold for statistical significance was p = 0.05|Mixed Models Analysis|Models adjusted for covariates (yielded estimated mean values of the outcome) and non-response weights based on completion of follow-up interviews.||||||>0.05
72350449|NCT02524171|144221441|SUPERIORITY||Other[Time x Condition at 12 mo.(Beta v|0.46|||<|0.01|TWO_SIDED|||||The threshold for statistical significance was p = 0.05|Mixed Models Analysis|Models adjusted for covariates (yielded estimated mean values of the outcome) and non-response weights based on completion of follow-up interviews.||Per protocol analysis, which included all UC participants (n=169) and only those in the MRT condition who had received the minimum recommended dose of the intervention - i.e., Step 3 or higher of MRT (n=63).||||<0.01
72350450|NCT02524171|144221442|SUPERIORITY||Other[Time x Condition at 12 mo.(Beta)|0.02|||>|0.05|TWO_SIDED|||||The threshold for statistical significance was p = 0.05.|Mixed Models Analysis|Models adjusted for covariates (yielded estimated mean values of the outcome) and non-response weights based on completion of follow-up interviews.||||||>0.05
72350451|NCT02524171|144221442|SUPERIORITY||Other[Time x Condition at 12 mo.(Beta)|-0.08|||>|0.05|TWO_SIDED|||||The threshold for statistical significance was p = 0.05|Mixed Models Analysis|Models adjusted for covariates (yielded estimated mean values of the outcome) and non-response weights based on completion of follow-up interviews.||Per protocol analysis, which included all UC participants (n=169) and only those in the MRT condition who had received the minimum recommended dose of the intervention - i.e., Step 3 or higher of MRT (n=63).||||>0.05
72350452|NCT02524171|144221443|SUPERIORITY||Other[Time x Condition at 12 mo.(Beta)]|-0.03|||>|0.05|TWO_SIDED|||||The threshold for statistical significance was p = 0.05.|Mixed Models Analysis|Models adjusted for covariates (yielded estimated mean values of the outcome) and non-response weights based on completion of follow-up interviews.||||||>0.05
72350453|NCT02524171|144221443|SUPERIORITY||Other[Time x Condition at 12 mo.(Beta)]|-0.07|||<|0.05|TWO_SIDED|||||The threshold for statistical significance was p = 0.05.|Mixed Models Analysis|Models adjusted for covariates (yielded estimated mean values of the outcome) and non-response weights based on completion of follow-up interviews.||Per protocol analysis, which included all UC participants (n=169) and only those in the MRT condition who had received the minimum recommended dose of the intervention - i.e., Step 3 or higher of MRT (n=63).||||<0.05
72350454|NCT02524171|144221444|SUPERIORITY||Other[Time x Condition at 12 mo.(Beta)]|0.01|||>|0.05|TWO_SIDED|||||The threshold for statistical significance was p = 0.05|Mixed Models Analysis|Models adjusted for covariates (yielded estimated mean values of the outcome) and non-response weights based on completion of follow-up interviews.||||||>0.05
72350455|NCT02524171|144221444|SUPERIORITY||Other[Time x Condition at 12 mo.(Beta)]|-0.08|||<|0.05|TWO_SIDED|||||The threshold for statistical significance was p = 0.05|Mixed Models Analysis|Models adjusted for covariates (yielded estimated mean values of the outcome) and non-response weights based on completion of follow-up interviews.||Per protocol analysis, which included all UC participants (n=169) and only those in the MRT condition who had received the minimum recommended dose of the intervention - i.e., Step 3 or higher of MRT (n=63).||||<0.05
72350456|NCT02524171|144221445|SUPERIORITY||Other[Time x Condition at 12 mo.(Beta)]|0.07|||<|0.05|TWO_SIDED|||||The threshold for statistical significance was p = 0.05|Mixed Models Analysis|Models adjusted for covariates (yielded estimated mean values of the outcome) and non-response weights based on completion of follow-up interviews.||||||<0.05
72350457|NCT02524171|144221445|SUPERIORITY||Other[Time x Condition at 12 mo.(Beta)]|0.08|||>|0.05|TWO_SIDED|||||The threshold for statistical significance was p = 0.05.|Mixed Models Analysis|Models adjusted for covariates (yielded estimated mean values of the outcome) and non-response weights based on completion of follow-up interviews.||Per protocol analysis, which included all UC participants (n=169) and only those in the MRT condition who had received the minimum recommended dose of the intervention - i.e., Step 3 or higher of MRT (n=63).||||>0.05
72350458|NCT00940901|144221446|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||Null hypothesis: there would be no difference in the number of participants who experienced at least a 50% reduction in the frequency of priapic episodes between baseline and 8 weeks post intervention, between the sildenafil and placebo groups||||1
72350459|NCT00940901|144221447|SUPERIORITY_OR_OTHER|||||||0.55|||||||Fisher Exact|||||||0.55
72350460|NCT00757237|144221448|NON_INFERIORITY_OR_EQUIVALENCE|The treatment difference (TIS-AZLI) and standard error from the ANCOVA model were used to compute the two-sided 95% confidence interval. If the 95% upper boundary was less than the pre-specified non-inferiority margin of 4%, then the null hypothesis was rejected.|Mean Difference (Final Values)|-7.8||||0.0001|TWO_SIDED|95.0|-11.73|-3.86||Based on the Benjamini \& Hochberg method, non-inferiority at Day 28 for relative change in FEV1 percent predicted was assessed at the 0.05 level, given the significance of the coprimary endpoint (p\<0.05).|ANCOVA|ANCOVA model included treatment, Day 0 FEV1 percent predicted, and previous inhaled tobramycin use for all participants.|Treatment difference refers to TIS-AZLI.|Null hypothesis: AZLI was inferior to TIS by more than 4% in the mean relative change of FEV1 percent predicted at Day 28. With 120 subjects per treatment group there was at least 85% power to declare noninferiority based on relative change from baseline at Day 28 in FEV1 percent predicted using the upper bound of a 2-tailed 95% CI for the difference in means with a noninferiority margin of 4, assuming a common standard deviation of 18% and true difference in means \[TIS-AZLI\] of -3.2%.||-3.86|-11.73|0.0001
72350461|NCT00757237|144221449|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.7||||0.0023||||||Based on the Benjamini \& Hochberg method, superiority at Weeks 4, 12, and 20 of actual change in FEV1 percent predicted was tested at the 0.05 level, given the significance of the coprimary endpoint (p\<0.05).|MMRM analysis|MMRM analysis included Day 0 FEV1 percent predicted, previous inhaled tobramycin use, treatment, visit, and treatment/visit interaction.|Treatment difference refers to TIS-AZLI.|"Null hypothesis: there was no difference between AZLI and TIS treatment groups in the mean actual change of FEV1 percent predicted across 3 treatment courses among all participants.~With 120 subjects per treatment group, there was at least 90% power at a 5% significance level to detect differences based upon actual change from baseline in FEV1 percent predicted (3.61%, 2.98%, 2.32%) between AZLI and TIS at Weeks 4, 12, and 20 with a common standard deviation of 9%."||||0.0023
72350462|NCT00757237|144221450|NON_INFERIORITY_OR_EQUIVALENCE|The treatment difference (TIS-AZLI) and standard error from the ANCOVA model were used to compute the two-sided 95% confidence interval. If the 95% upper boundary was less than the pre-specified non-inferiority margin of 4%, then the null hypothesis was rejected.|Mean Difference (Final Values)|-9.5|||<|0.0001|TWO_SIDED|95.0|-13.86|-5.14||Secondary endpoints were tested sequentially by the closed testing procedure initiated by the significance of the primary endpoints. Given the coprimary endpoints were met at the 0.05 level, this non-inferiority endpoint was tested at the 0.05 level.|ANCOVA|ANCOVA model included treatment and Day 0 FEV1 percent predicted.|Treatment difference refers to TIS-AZLI.|Null hypothesis: AZLI was inferior to TIS by more than 4% in terms of the participant means in relative change of FEV1 percent predicted at Day 28 among all participants having \>= 84 days of inhaled tobramycin use in the previous 12 months.||-5.14|-13.86|<0.0001
72350463|NCT00757237|144221451|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.47||||0.0002||||||Secondary endpoints were tested sequentially to control the Type I error rate based on the closed testing procedure. Given the significance of the coprimary endpoints and previous secondary endpoint, this endpoint was also tested at the 0.05 level.|MMRM analysis|MMRM analysis included treatment, Day 0 FEV1 percent predicted, visit, treatment, and treatment/visit interaction for all participants.|Treatment difference refers to TIS-AZLI|Null hypothesis: there was no difference between AZLI and TIS treatment groups in the mean actual change of FEV1 percent predicted across 3 treatment courses in the stratum of subjects having \>=84 days of inhaled tobramycin use in the previous 12 months.||||0.0002
72429203|NCT01058863|144369414|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.15|STANDARD_ERROR_OF_MEAN|0.136|<|0.0001|TWO_SIDED|95.0|0.88|1.42||Significance at the 0.05 level.|ANOVA|Fixed effects of baseline FEV1 as a covariate, sequence, treatment group, period, and center, and random effect for subject within sequence.||Of interest was the mean difference between each active group and placebo at each dose level. Analyses were performed at the 2-sided 0.05 significance level in this sequence: Albuterol Spiromax 180 mcg versus placebo; Albuterol Spiromax 90 mcg versus placebo, ProAir HFA 180 mcg versus placebo, and ProAir HFA 90 mcg versus placebo. If a test was not significant, no further tests were done. This sequential procedure preserved the error rate for the family of tests at the 0.05 level.||1.42|0.88|<0.0001
72350464|NCT00757237|144221452|SUPERIORITY_OR_OTHER|||||||0.0025|TWO_SIDED|||||Secondary endpoints were tested sequentially to control the Type I error rate based on the closed testing procedure. Given the significance of the coprimary endpoints and previous secondary endpoint, this endpoint was also tested at the 0.05 level.|Log Rank|||Null hypothesis: there was no difference between AZLI and TIS treatment groups with respect to time to need for IV antipseudomonal antibiotics for respiratory events.||||0.0025
72350465|NCT00757237|144221453|SUPERIORITY_OR_OTHER|||||||0.1114||||||Secondary endpoints were tested sequentially to control the Type I error rate based on the closed testing procedure. Given the significance of the coprimary endpoints and previous secondary endpoint, this endpoint was also tested at the 0.05 level.|Log Rank|||Null hypothesis: there was no difference between AZLI and TIS treatment groups with respect to time to first respiratory hospitalization.||||0.1114
72350466|NCT00757237|144221454|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.61||||0.0048||0.0||||No adjustments were made for multiple comparisons.|ANCOVA|ANCOVA model included treatment, Day 0 FEV1 percent predicted, Day 0 CFQ-R RSS score, and previous inhaled tobramycin use.|Treatment difference refers to TIS-AZLI.|Null hypothesis: there was no difference between AZLI and TIS treatment groups in change from baseline in CFQ-R RSS scores at Day 28.||||0.0048
72350467|NCT00757237|144221455|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.13||||0.0189||0.0||||No adjustments were made for multiple comparisons.|ANCOVA|ANCOVA model included treatment, Day 0 FEV1 percent predicted, Day 0 CFQ-R RSS score, and previous inhaled tobramycin use.|Treatment difference refers to TIS-AZLI.|Null hypothesis: there was no difference between AZLI and TIS treatment groups in the average actual change in respiratory symptoms at the end of each treatment course (Weeks 4, 12, and 20).||||0.0189
72350468|NCT00757237|144221456|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.12||||0.0097||0.0||||No adjustments were made for multiple comparisons.|ANCOVA|ANCOVA model included treatment, Day 0 FEV1 percent predicted, and previous inhaled tobramycin use.|Treatment difference refers to TIS-AZLI.|Null hypothesis: there was no difference between AZLI and TIS treatment groups in the global satisfaction results of the TSQM at Week 20 (Day 140).||||0.0097
72350469|NCT00757237|144221457|SUPERIORITY_OR_OTHER|||||||0.044||||||No adjustments were made for multiple comparisons.|negative binomial regression method|||Null hypothesis: there was no difference between AZLI and TIS treatment groups in the total number of respiratory hospitalizations from Day 0 to Day 168 (end of study).||||0.044
72350470|NCT00757237|144221458|SUPERIORITY_OR_OTHER|||||||0.004||0.0||||No adjustments were made for multiple comparisons.|negative binomial regression method|||Null hypothesis: there was no difference between AZLI and TIS treatment groups in the total number of respiratory events requiring IV and/or inhaled antipseudomonal antibiotics (other than randomized treatment) from Day 0 to Day 168 (end of study).||||0.004
72350471|NCT00757237|144221459|SUPERIORITY_OR_OTHER|||||||0.0004||||||No adjustments were made for multiple comparisons.|Log Rank|||Null hypothesis: there was no difference between AZLI and TIS treatment groups with respect to time to need for inhaled and/or IV antipseudomonal antibiotics for respiratory events.||||0.0004
72350472|NCT01100320|144221489|NON_INFERIORITY_OR_EQUIVALENCE|A mixed-model analysis of variance was used to compare (test vs reference) and the 90% confidence intervals were estimated for the ratios (test/reference).|Geometric Test/Ref Ratio x 100|99.9|||||TWO_SIDED|90.0|95.4|104.52|||ANOVA||Bioequivalence is established when 90% Confidence Interval falls within 80%-125%.|||104.52|95.40|
72350473|NCT01100320|144221490|NON_INFERIORITY_OR_EQUIVALENCE|A mixed-model analysis of variance was used to compare (test vs reference) and the 90% confidence intervals were estimated for the ratios (test/reference).|Geometric Test/Ref Ratio x 100|92.6|||||TWO_SIDED|90.0|90.11|95.09|||ANOVA||Bioequivalence is established when 90% Confidence Interval falls within 80%-125%.|||95.09|90.11|
72350474|NCT01100320|144221491|NON_INFERIORITY_OR_EQUIVALENCE|A mixed-model analysis of variance was used to compare (test vs reference) and the 90% confidence intervals were estimated for the ratios (test/reference)|Geometric Test/Ref Ratio x 100|92.6|||||TWO_SIDED|90.0|90.13|95.13|||ANOVA||Bioequivalence is established when 90% Confidence Interval falls within 80%-125%.|||95.13|90.13|
72350475|NCT01147055|144221518|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|18.21|||||TWO_SIDED|90.0|16.14|20.54||||||Natural log transformed AUC (0-∞) of crizotinib was analyzed using a mixed effect model with treatment as a fixed effect and participant as a random effect. The adjusted mean differences and 90% confidence intervals (CIs) for the differences was exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||20.54|16.14|
72350476|NCT01147055|144221519|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|31.49|||||TWO_SIDED|90.0|26.43|37.51||||||Natural log transformed Cmax of crizotinib was analyzed using a mixed effect model with treatment as a fixed effect and participant as a random effect. The adjusted mean differences and 90% CIs for the differences was exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||37.51|26.43|
72350477|NCT01147055|144221520|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|17.6|||||TWO_SIDED|90.0|15.48|20.02||||||Natural log transformed AUClast of crizotinib was analyzed using a mixed effect model with treatment as a fixed effect and participant as a random effect. The adjusted mean differences and 90% CIs for the differences was exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||20.02|15.48|
72350478|NCT01147055|144221525|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|5.49|||||TWO_SIDED|90.0|4.64|6.49||||||Natural log transformed AUClast of PF-06260182 was analyzed using a mixed effect model with treatment as a fixed effect and participant as a random effect. The adjusted mean differences and 90% CIs for the differences was exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||6.49|4.64|
72350479|NCT01147055|144221526|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|5.75|||||TWO_SIDED|90.0|4.86|6.81||||||Natural log transformed AUC (0 - ∞) of PF-06260182 was analyzed using a mixed effect model with treatment as a fixed effect and participant as a random effect. The adjusted mean differences and 90% CIs for the differences was exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||6.81|4.86|
72350480|NCT01147055|144221528|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|11.01|||||TWO_SIDED|90.0|9.02|13.45||||||Natural log transformed Cmax of PF-06260182 was analyzed using a mixed effect model with treatment as a fixed effect and participant as a random effect. The adjusted mean differences and 90% CIs for the differences was exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||13.45|9.02|
72350481|NCT01746225|144221551|SUPERIORITY|||||||0.12||||||Not adjusted for multiple comparisons; One-sided .05 alpha-level test|Log Rank|One-sided test||For each arm separately, PFS was compared to the historic PFS of first-line docetaxel using a one-sample one-sided log-rank test, of the null hypothesis, H0: median PFS≤7 months vs. H1: median PFS\>7 months.||||0.12
72350482|NCT01746225|144221551|SUPERIORITY|||||||0.03||||||Not adjusted for multiple comparisons; One-sided .05 alpha-level test|Log Rank|One-sided test||For each arm separately, PFS was compared to the historic PFS of first-line docetaxel using a one-sample one-sided log-rank test, of the null hypothesis, H0: median PFS≤7 months vs. H1: median PFS\>7 months.||||.03
72350483|NCT01746225|144221551|SUPERIORITY|||||||0.2||||||Not adjusted for multiple comparisons; One-sided .05 alpha-level test|Log Rank|One-sided test||For each arm separately, PFS was compared to the historic PFS of first-line docetaxel using a one-sample one-sided log-rank test, of the null hypothesis, H0: median PFS≤7 months vs. H1: median PFS\>7 months.||||.20
72350484|NCT00595478|144221557|SUPERIORITY||Odds Ratio (OR)|0.8||||0.66|TWO_SIDED|95.0|0.29|2.18|||Poisson regression|Chi-square test with 1 degree of freedom|Odds ratio for 0 ETG-positive samples for MET/CBT+CM/BPT (numerator) vs. MET/CTB (denominator)|||2.18|0.29|0.66
72350485|NCT00595478|144221557|SUPERIORITY||mean ratio|0.93||||0.61|TWO_SIDED|95.0|0.71|1.22|||Poisson regression|Chi-square test with 1 degree of freedom|Mean ratio for number of ETG-positive samples, if \>0 ETG-positive samples: MET/CBT+CM/BPT (numerator) vs. MET/CTB (denominator)|||1.22|0.71|0.61
72350486|NCT00595478|144221558|SUPERIORITY||Odds Ratio (OR)|0.82||||0.74|TWO_SIDED|95.0|0.26|2.62|||Poisson regression|Chi-square test with 1 degree of freedom|Odds ratio for 0% days using alcohol during the 36 week follow-up period: MET/CBT+CM/BPT (numerator) vs. MET/CTB (denominator)|||2.62|0.26|0.74
72350487|NCT00595478|144221558|SUPERIORITY||mean ratio|0.74||||0.007|TWO_SIDED|95.0|0.59|0.92|||Poisson regression|Chi-square test with 1 degree of freedom|Mean ratio for percentage of days with alcohol use during the 36 week follow-up period, if alcohol was used: MET/CBT+CM/BPT (numerator) vs. MET/CTB (denominator)|||.92|.59|0.007
72350488|NCT02451514|144221562|OTHER||Geometric mean ratio|1.48|||||TWO_SIDED|95.0|1.03|2.12|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B, M14459.||2.12|1.03|
72350489|NCT02451514|144221562|OTHER||Geometric mean ratio|0.93|||||TWO_SIDED|95.0|0.67|1.28|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B, M14459.||1.28|0.67|
72350490|NCT02451514|144221562|OTHER||Geometric mean ratio|1.38|||||TWO_SIDED|95.0|0.97|1.96|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B, M14459.||1.96|0.97|
72350491|NCT02451514|144221562|OTHER||Geometric mean ratio|1.98|||||TWO_SIDED|95.0|1.27|3.09|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B, M01-0240364.||3.09|1.27|
72350492|NCT02451514|144221562|OTHER||Geometric mean ratio|0.93|||||TWO_SIDED|95.0|0.63|1.37|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B, M01-0240364.||1.37|0.63|
72350493|NCT02451514|144221562|OTHER||Geometric mean ratio|1.84|||||TWO_SIDED|95.0|1.2|2.84|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B, M01-0240364.||2.84|1.20|
72350494|NCT02451514|144221562|OTHER||Geometric mean ratio|1.34|||||TWO_SIDED|95.0|0.96|1.85|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B, NZ98/254.||1.85|0.96|
72350495|NCT02451514|144221562|OTHER||Geometric mean ratio|0.94|||||TWO_SIDED|95.0|0.7|1.25|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B, NZ98/254.||1.25|0.70|
72350496|NCT02451514|144221562|OTHER||Geometric mean ratio|1.25|||||TWO_SIDED|95.0|0.91|1.72|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B, NZ98/254.||1.72|0.91|
72350497|NCT02451514|144221562|OTHER||Geometric mean ratio|1.43|||||TWO_SIDED|95.0|0.81|2.53|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B, M10713.||2.53|0.81|
72350498|NCT02451514|144221562|OTHER||Geometric mean ratio|0.82|||||TWO_SIDED|95.0|0.49|1.37|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B, M10713.||1.37|0.49|
72350499|NCT02451514|144221562|OTHER||Geometric mean ratio|1.18|||||TWO_SIDED|95.0|0.67|2.06|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B, M10713.||2.06|0.67|
72350500|NCT02451514|144221562|OTHER||Geometric mean ratio|1.92|||||TWO_SIDED|95.0|1.33|2.78|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B, H44/76.||2.78|1.33|
72350501|NCT02451514|144221562|OTHER||Geometric mean ratio|0.84|||||TWO_SIDED|95.0|0.61|1.17|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B, H44/76.||1.17|0.61|
72350502|NCT02451514|144221562|OTHER||Geometric mean ratio|1.62|||||TWO_SIDED|95.0|1.13|2.32|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B, H44/76.||2.32|1.13|
72350503|NCT02451514|144221562|OTHER||Geometric mean ratio|7.15|||||TWO_SIDED|95.0|4.25|12.0|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B, 5/99.||12|4.25|
72350504|NCT02451514|144221562|OTHER||Geometric mean ratio|0.94|||||TWO_SIDED|95.0|0.59|1.5|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B, 5/99.||1.50|0.59|
72350505|NCT02451514|144221562|OTHER||Geometric mean ratio|6.73|||||TWO_SIDED|95.0|4.03|11.0|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B, 5/99.||11|4.03|
72350506|NCT02451514|144221562|OTHER||Geometric mean ratio|0.61|||||TWO_SIDED|95.0|0.3|1.23|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup A.||1.23|0.30|
72350507|NCT02451514|144221562|OTHER||Geometric mean ratio|5.53|||||TWO_SIDED|95.0|2.96|10.0|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup A.||10|2.96|
72350508|NCT02451514|144221562|OTHER||Geometric mean ratio|3.38|||||TWO_SIDED|95.0|1.7|6.73|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup A.||6.73|1.70|
72350509|NCT02451514|144221562|OTHER||Geometric mean ratio|2.58|||||TWO_SIDED|95.0|1.2|5.54|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup C.||5.54|1.20|
72350510|NCT02451514|144221562|OTHER||Geometric mean ratio|1.3|||||TWO_SIDED|95.0|0.66|2.56|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup C.||2.56|0.66|
72350511|NCT02451514|144221562|OTHER||Geometric mean ratio|3.34|||||TWO_SIDED|95.0|1.57|7.11|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup C.||7.11|1.57|
72350512|NCT02451514|144221562|OTHER||Geometric mean ratio|1.14|||||TWO_SIDED|95.0|0.51|2.59|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup W.||2.59|0.51|
72350513|NCT02451514|144221562|OTHER||Geometric mean ratio|2.93|||||TWO_SIDED|95.0|1.4|6.12|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup W.||6.12|1.40|
72350514|NCT02451514|144221562|OTHER||Geometric mean ratio|3.35|||||TWO_SIDED|95.0|1.49|7.57|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup W.||7.57|1.49|
72350515|NCT02451514|144221562|OTHER||Geometric mean ratio|0.52|||||TWO_SIDED|95.0|0.23|1.18|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup Y.||1.18|0.23|
72350516|NCT02451514|144221562|OTHER||Geometric mean ratio|5.94|||||TWO_SIDED|95.0|2.84|12.0|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup Y.||12|2.84|
72350517|NCT02451514|144221562|OTHER||Geometric mean ratio|3.09|||||TWO_SIDED|95.0|1.38|6.92|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup Y.||6.92|1.38|
72350518|NCT02451514|144221566|OTHER||Geometric mean ratio|8.5|||||TWO_SIDED|95.0|4.41|16.0|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B, M14459.||16|4.41|
72350519|NCT02451514|144221566|OTHER||Geometric mean ratio|0.7|||||TWO_SIDED|95.0|0.39|1.27|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B, M14459.||1.27|0.39|
72350520|NCT02451514|144221566|OTHER||Geometric mean ratio|5.97|||||TWO_SIDED|95.0|3.14|11.0|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B, M14459.||11|3.14|
72350521|NCT02451514|144221566|OTHER||Geometric mean ratio|197.0|||||TWO_SIDED|95.0|86.0|452.0|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B, M01-0240364.||452|86|
72350522|NCT02451514|144221566|OTHER||Geometric mean ratio|0.98|||||TWO_SIDED|95.0|0.47|2.07|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B, M01-0240364.||2.07|0.47|
72350523|NCT02451514|144221566|OTHER||Geometric mean ratio|193.0|||||TWO_SIDED|95.0|84.0|442.0|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B, M01-0240364.||442|84|
72350524|NCT02451514|144221566|OTHER||Geometric mean ratio|3.51|||||TWO_SIDED|95.0|1.96|6.27|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B, NZ98/254.||6.27|1.96|
72350525|NCT02451514|144221566|OTHER||Geometric mean ratio|0.62|||||TWO_SIDED|95.0|0.37|1.0|||Mixed Models Analysis|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B, NZ98/254.||1.0|0.37|
72350526|NCT02451514|144221566|OTHER||Geometric mean ratio|2.17|||||TWO_SIDED|95.0|1.23|3.85|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B, NZ98/254.||3.85|1.23|
72350527|NCT02451514|144221566|OTHER||Geometric mean ratio|3.57|||||TWO_SIDED|95.0|1.84|6.92|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B, M10713.||6.92|1.84|
72350528|NCT02451514|144221566|OTHER||Geometric mean ratio|0.72|||||TWO_SIDED|95.0|0.4|1.29|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B, M10713.||1.29|0.40|
72350529|NCT02451514|144221566|OTHER||Geometric mean ratio|2.55|||||TWO_SIDED|95.0|1.33|4.89|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B, M10713.||4.89|1.33|
72350530|NCT02451514|144221566|OTHER||Geometric mean ratio|17.0|||||TWO_SIDED|95.0|8.18|35.0|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B, H44/76.||35|8.18|
72350531|NCT02451514|144221566|OTHER||Geometric mean ratio|0.8|||||TWO_SIDED|95.0|0.41|1.53|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B, H44/76.||1.53|0.41|
72350532|NCT02451514|144221566|OTHER||Geometric mean ratio|13.0|||||TWO_SIDED|95.0|6.59|28.0|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B, H44/76.||28|6.59|
72350533|NCT02451514|144221566|OTHER||Geometric mean ratio|74.0|||||TWO_SIDED|95.0|34.0|160.0|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B, 5/99.||160|34|
72350534|NCT02451514|144221566|OTHER||Geometric mean ratio|0.77|||||TWO_SIDED|95.0|0.38|1.53|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B, 5/99.||1.53|0.38|
72350535|NCT02451514|144221566|OTHER||Geometric mean ratio|57.0|||||TWO_SIDED|95.0|27.0|121.0|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B, 5/99.||121|27|
72350536|NCT02451514|144221566|OTHER||Geometric mean ratio|2.66|||||TWO_SIDED|95.0|1.46|4.83|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup A.||4.83|1.46|
72350537|NCT02451514|144221566|OTHER||Geometric mean ratio|6.76|||||TWO_SIDED|95.0|3.96|12.0|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup A.||12|3.96|
72350538|NCT02451514|144221566|OTHER||Geometric mean ratio|18.0|||||TWO_SIDED|95.0|10.0|32.0|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup A.||32|10|
72350539|NCT02451514|144221566|OTHER||Geometric mean ratio|1.4|||||TWO_SIDED|95.0|0.72|2.71|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup C.||2.71|0.72|
72350540|NCT02451514|144221566|OTHER||Geometric mean ratio|21.0|||||TWO_SIDED|95.0|12.0|37.0|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup C.||37|12|
72350541|NCT02451514|144221566|OTHER||Geometric mean ratio|29.0|||||TWO_SIDED|95.0|15.0|55.0|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup C.||55|15|
72350542|NCT02451514|144221566|OTHER||Geometric mean ratio|0.81|||||TWO_SIDED|95.0|0.47|1.38|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup W.||1.38|0.47|
72350543|NCT02451514|144221566|OTHER||Geometric mean ratio|19.0|||||TWO_SIDED|95.0|12.0|31.0|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup W.||31|12|
72350544|NCT02451514|144221566|OTHER||Geometric mean ratio|16.0|||||TWO_SIDED|95.0|9.27|26.0|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup W.||26|9.27|
72350545|NCT02451514|144221566|OTHER||Geometric mean ratio|0.46|||||TWO_SIDED|95.0|0.17|1.28|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup Y.||1.28|0.17|
72350546|NCT02451514|144221566|OTHER||Geometric mean ratio|20.0|||||TWO_SIDED|95.0|8.2|48.0|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup Y.||48|8.20|
72350547|NCT02451514|144221566|OTHER||Geometric mean ratio|9.13|||||TWO_SIDED|95.0|3.78|22.0|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup Y.||22|3.78|
72350548|NCT02451514|144221579|OTHER||Geometric mean ratio|0.49|||||TWO_SIDED|95.0|0.28|0.87|||Miettinen & Nurminen score method|||Between-group GMT ratios against N. meningitidis Serogroup B, M14459||0.87|0.28|
72350549|NCT02451514|144221579|OTHER||Geometric mean ratio|0.91|||||TWO_SIDED|95.0|0.4|2.11|||Miettinen & Nurminen score method|||Between-group GMT ratios against N. meningitidis Serogroup B, M01-0240364||2.11|0.40|
72350550|NCT02451514|144221579|OTHER||Geometric mean ratio|0.83|||||TWO_SIDED|95.0|0.5|1.38|||Miettinen & Nurminen score method|||Between-group GMT ratios against N. meningitidis serogroup B, NZ98/254||1.38|0.50|
72350551|NCT02451514|144221579|OTHER||Geometric mean ratio|0.79|||||TWO_SIDED|95.0|0.44|1.44|||Miettinen & Nurminen score method|||Between-group GMT ratios against N. meningitidis serogroup B, M10713||1.44|0.44|
72350552|NCT02451514|144221579|OTHER||Geometric mean ratio|0.6|||||TWO_SIDED|95.0|0.34|1.07|||Miettinen & Nurminen score method|||Between-group GMT ratios against N. meningitidis serogroup B, H44/76||1.07|0.34|
72350553|NCT02451514|144221579|OTHER||Geometric mean ratio|0.77|||||TWO_SIDED|95.0|0.52|1.12|||Miettinen & Nurminen score method|||Between-group GMT ratios against N. meningitidis serogroup B, 5/99||1.12|0.52|
72350554|NCT02451514|144221579|OTHER||Geometric mean ratio|2.99|||||TWO_SIDED|95.0|1.89|4.75|||Miettinen & Nurminen score method|||Between-group GMT ratios against N. meningitidis serogroup A||4.75|1.89|
72350555|NCT02451514|144221579|OTHER||Geometric mean ratio|4.69|||||TWO_SIDED|95.0|3.01|7.31|||Miettinen & Nurminen score method|||Between-group GMT ratios against N. meningitidis serogroup C||7.31|3.01|
72429204|NCT01058863|144369414|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.97|STANDARD_ERROR_OF_MEAN|0.136|<|0.0001|TWO_SIDED|95.0|0.7|1.24||Significance at the 0.05 level.|ANOVA|Fixed effects of baseline FEV1 as a covariate, sequence, treatment group, period, and center, and random effect for subject within sequence.||Of interest was the mean difference between each active group and placebo at each dose level. Analyses were performed at the 2-sided 0.05 significance level in this sequence: Albuterol Spiromax 180 mcg versus placebo; Albuterol Spiromax 90 mcg versus placebo, ProAir HFA 180 mcg versus placebo, and ProAir HFA 90 mcg versus placebo. If a test was not significant, no further tests were done. This sequential procedure preserved the error rate for the family of tests at the 0.05 level.||1.24|0.70|<0.0001
72350556|NCT02451514|144221579|OTHER||Geometric mean ratio|8.6|||||TWO_SIDED|95.0|5.84|13.0|||Miettinen & Nurminen score method|||Between-group GMT ratios against N. meningitidis serogroup W||13|5.84|
72350557|NCT02451514|144221579|OTHER||Geometric mean ratio|7.03|||||TWO_SIDED|95.0|3.96|12.0|||Miettinen & Nurminen score method|||Between-group GMT ratios against N. meningitidis serogroup Y||12|3.96|
72350558|NCT03691571|144221601|SUPERIORITY||||||>|0.05|||||||Fisher Exact|||Esophageal thermal injury was detected in 13/44 (30%) patients.||||>.05
72350559|NCT03691571|144221603|OTHER|feasibility/pilot study||||||0.11|||||||Wilcoxon (Mann-Whitney)|||||||0.11
72350560|NCT03691571|144221604|OTHER|feasibility/pilot study||||||0.73|||||||Wilcoxon (Mann-Whitney)|||||||0.73
72350561|NCT03691571|144221605|OTHER|feasibility/pilot study||||||0.1|||||||Fisher Exact|||||||0.10
72350562|NCT00186901|144221610|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.02||||0.86||95.0|||||Wilcoxon Test|||Baseline where N=134||||0.86
72350563|NCT00186901|144221610|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.17||||0.99||95.0|||||Wilcoxon Test|||12 Month BMD Z-Score Calculation where N=109||||0.99
72350564|NCT00186901|144221610|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.04||||0.54||95.0|||||Wilcoxon Test|||24 Month BMD Z-Score calculation where N=91||||0.54
72350565|NCT00186901|144221610|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.04||||0.31||95.0|||||Wilcoxon Test|||36 Month (End of Study) BMD Z-Score calculation where N=84||||0.31
72350566|NCT00186901|144221611|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.32||||0.0004||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0004
72350567|NCT00186901|144221612|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.69||||0.0023||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0023
72350568|NCT00186901|144221613|SUPERIORITY_OR_OTHER|||||||0.0092||95.0|||||Kruskal-Wallis|||||||0.0092
72350569|NCT00186901|144221614|SUPERIORITY_OR_OTHER||Correlation coefficient|0.41|||<|0.0001|TWO_SIDED|95.0|0.25|0.55|||Z-test|||275 received a QCT and 121 received a DXA scan. 121 paired scans were evaluated.||0.55|0.25|<0.0001
72350570|NCT00186901|144221615|SUPERIORITY_OR_OTHER||Correlation coefficient|0.54|||<|0.0001|TWO_SIDED|95.0|0.38|0.67|||Z-test|||218 patients were assessed at 12 months and received a QCT Scan. 94 patients were also assessed using the DEXA Scan. Comparison of the two methods used 94 paired studies to arrive at a correlation coefficient.||0.67|0.38|<0.0001
72350571|NCT00186901|144221616|SUPERIORITY_OR_OTHER||Correlation coefficient|0.53|||<|0.0001|TWO_SIDED|95.0|0.36|0.66|||Z-test|||188 patients were assessed at baseline and received a QCT Scan. 90 patients were also assessed using the DEXA Scan. Comparison of the two methods used 90 paired studies to arrive at a correlation coefficient.||0.66|0.36|<0.0001
72350572|NCT00186901|144221617|SUPERIORITY_OR_OTHER||Correlation coefficient|0.48|||<|0.0001|TWO_SIDED|95.0|0.3|0.63|||Z-test|||180 patients were assessed at 36 months and received a QCT Scan. 89 patients were also assessed using the DXA Scan. Comparison of the two methods used 89 paired studies to arrive at a correlation coefficient.||0.63|0.30|<0.0001
72350573|NCT00186901|144221618|SUPERIORITY_OR_OTHER|||||||0.4||95.0|||||Kruskal Wallis|||||||0.40
72350574|NCT00186901|144221619|SUPERIORITY_OR_OTHER|||||||0.21||95.0|||||Kruskal Wallis|||||||0.21
72350575|NCT00291486|144221656|SUPERIORITY|||||||0.144|||||||t-test, 1 sided|||Comparison of CL between initial infusion and therapy infusion||||0.144
72350576|NCT00291486|144221657|SUPERIORITY|||||||0.361|||||||ANOVA|||||||0.361
72350577|NCT01099397|144221670|SUPERIORITY_OR_OTHER|||||||0.41||||||P-value at baseline|McNemar|McNemar was used at each of three time points to compare prediabetes diagnosis by fasting versus 2-hour OGTT||p\<0.05 was considered significant at baseline; the null hypothesis was that there was no difference between prediabetes diagnosis (by 2-hour glucose or fasting glucose), the alternative hypothesis was that there was a significant difference between prediabetes diagnosis (by 2-hour glucose or fasting glucose)||||0.41
72350578|NCT01099397|144221670|SUPERIORITY_OR_OTHER|||||||0.59||95.0||||P-value at 9 weeks|McNemar|McNemar was used at each of three time points to compare prediabetes diagnosis by fasting versus 2-hour OGTT||p\<0.05 was considered significant at 9 week assessment; the null hypothesis was that there was no difference between prediabetes diagnosis (by 2-hour glucose or fasting glucose), the alternative hypothesis was that there was a significant difference between prediabetes diagnosis (by 2-hour glucose or fasting glucose)||||0.59
72350579|NCT01099397|144221670|SUPERIORITY_OR_OTHER|||||||0.41||95.0||||P-value at 18 weeks|McNemar|McNemar was used at each of three time points to compare prediabetes diagnosis by fasting versus 2-hour OGTT||p\<0.05 was considered significant at 18 week assessment; the null hypothesis was that there was no difference between prediabetes diagnosis (by 2-hour glucose or fasting glucose), the alternative hypothesis was that there was a significant difference between prediabetes diagnosis (by 2-hour glucose or fasting glucose)||||0.41
72350580|NCT02363959|144221671|OTHER||Odds Ratio (OR)|1.0||||1|TWO_SIDED||||||Fisher Exact|||||||1
72350581|NCT02363959|144221672|OTHER|||||||0.39|||||||Fisher Exact|||||||0.39
72350582|NCT02363959|144221673|OTHER|||||||1|||||||Fisher Exact|||||||1
72350583|NCT02363959|144221674|OTHER|||||||1|||||||Fisher Exact|||||||1
72350584|NCT02363959|144221675|OTHER|||||||1|||||||Fisher Exact|||||||1
72350585|NCT02363959|144221676|OTHER|||||||1|||||||Fisher Exact|||||||1
72350586|NCT02267538|144221705|OTHER||Odds Ratio (OR)|0.62||||0.341|TWO_SIDED|95.0|0.23|1.65|||Regression, Logistic|||||1.65|0.23|0.341
72350587|NCT02267538|144221706|OTHER||Median Difference (Final Values)|0.0||||0.83|TWO_SIDED|||||MMSE|Wilcoxon (Mann-Whitney)|||||||0.830
72350588|NCT02267538|144221706|OTHER||Median Difference (Final Values)|0.0||||0.405|TWO_SIDED|||||m-TICS|Wilcoxon (Mann-Whitney)|||||||0.405
72350589|NCT02267538|144221707|OTHER||Odds Ratio (OR)|0.74||||0.214|TWO_SIDED|95.0|0.47|1.19|||Regression, Logistic|||Incidence of total non-delirium complications within 30 days after surgery||1.19|0.47|0.214
72350590|NCT02267538|144221707|OTHER|stroke|Odds Ratio (OR)|1.01||||0.993|TWO_SIDED|95.0|0.2|5.08|||Regression, Logistic|||Incidence of stroke within 30 days after surgery||5.08|0.20|0.993
72350591|NCT02267538|144221707|OTHER|New onset arrythmia|Odds Ratio (OR)|0.76||||0.274|TWO_SIDED|95.0|0.46|1.25|||Regression, Logistic|||||1.25|0.46|0.274
72350592|NCT02267538|144221707|OTHER|Pulmonary complications|Odds Ratio (OR)|0.51||||0.05|TWO_SIDED|95.0|0.26|1.0|||Regression, Logistic|||||1.00|0.26|0.050
72350593|NCT02267538|144221707|OTHER||Odds Ratio (OR)|0.5||||0.423|TWO_SIDED|95.0|0.09|2.75||Upper gastrointestinal bleeding|Regression, Logistic|||||2.75|0.09|0.423
72350594|NCT02267538|144221707|OTHER||Odds Ratio (OR)|1.01||||0.993|TWO_SIDED|95.0|0.2|5.08||Surgical bleeding|Regression, Logistic|||||5.08|0.20|0.993
72350595|NCT02267538|144221707|OTHER||Odds Ratio (OR)|1.63||||0.326|TWO_SIDED|95.0|0.61|4.34||Wound dehiscence or infection|Regression, Logistic|||||4.34|0.61|0.326
72350596|NCT02267538|144221707|OTHER||Odds Ratio (OR)|0.79||||0.378|TWO_SIDED|95.0|0.47|1.33||Acute kidney injur|Regression, Logistic|||||1.33|0.47|0.378
72350597|NCT02267538|144221707|OTHER||Odds Ratio (OR)|0.48||||0.156|TWO_SIDED|95.0|0.18|1.32||IABP assistance|Regression, Logistic|||||1.32|0.18|0.156
72350598|NCT02267538|144221708|OTHER||Median Difference (Final Values)|0.0||||0.596|TWO_SIDED|95.0|-1.0|0.0|||Wilcoxon (Mann-Whitney)|||this statistical analysis applies to the first row in Outcome 4, i.e., Pain score in Day 1 after surgery, at rest between DEX Group and CTRL group||0|-1|0.596
72350599|NCT02267538|144221708|OTHER||Median Difference (Final Values)|0.0||||0.743|TWO_SIDED|95.0|-1.0|0.0|||Wilcoxon (Mann-Whitney)|||this statistical analysis applies to the second row in Outcome 4, i.e., Pain score in Day 2 after surgery, at rest between DEX Group and CTRL group||0|-1|0.743
72350600|NCT02267538|144221708|OTHER||Median Difference (Final Values)|0.0||||0.282|TWO_SIDED|95.0|-1.0|0.0|||Wilcoxon (Mann-Whitney)|||this statistical analysis applies to the third row in Outcome 4, i.e., Pain score in Day 3 after surgery, at rest between DEX Group and CTRL group||0|-1|0.282
72350601|NCT02267538|144221708|OTHER||Median Difference (Final Values)|0.0||||0.368|TWO_SIDED|95.0|0.0|0.0|||Wilcoxon (Mann-Whitney)|||this statistical analysis applies to the fourth row in Outcome 4, i.e., Pain score in Day 4 after surgery, at rest between DEX Group and CTRL group||0|0|0.368
72350602|NCT02267538|144221708|OTHER||Median Difference (Final Values)|0.0||||0.397|TWO_SIDED|95.0|0.0|0.0|||Wilcoxon (Mann-Whitney)|||this statistical analysis applies to the fifth row in Outcome 4, i.e., Pain score in Day 5 after surgery, at rest between DEX Group and CTRL group||0|0|0.397
72350603|NCT02267538|144221708|OTHER||Median Difference (Final Values)|0.0||||0.486|TWO_SIDED|95.0|-1.0|0.0|||Wilcoxon (Mann-Whitney)|||this statistical analysis applies to the sixth row in Outcome 4, i.e., Pain score in Day 1 after surgery, with coughing between DEX Group and CTRL group||0|-1|0.486
72350604|NCT02267538|144221708|OTHER||Median Difference (Final Values)|0.0||||0.414|TWO_SIDED|95.0|-1.0|0.0|||Wilcoxon (Mann-Whitney)|||this statistical analysis applies to the seventh row in Outcome 4, i.e., Pain score in Day 2 after surgery, with coughing between DEX Group and CTRL group||0|-1|0.414
72350605|NCT02267538|144221708|OTHER||Median Difference (Final Values)|0.0||||0.187|TWO_SIDED|95.0|-1.0|0.0|||Wilcoxon (Mann-Whitney)|||this statistical analysis applies to the eighth row in Outcome 4, i.e., Pain score in Day 3 after surgery, with coughing between DEX Group and CTRL group||0|-1|0.187
72350606|NCT02267538|144221708|OTHER||Median Difference (Final Values)|0.0||||0.127|TWO_SIDED|95.0|-1.0|0.0|||Wilcoxon (Mann-Whitney)|||this statistical analysis applies to the ninth row in Outcome 4, i.e., Pain score in Day 4 after surgery, with coughing between DEX Group and CTRL group||0|-1|0.127
72350607|NCT02267538|144221708|OTHER||Median Difference (Final Values)|0.0||||0.378|TWO_SIDED|95.0|0.0|0.0|||Wilcoxon (Mann-Whitney)|||this statistical analysis applies to the tenth row in Outcome 4, i.e., Pain score in Day 5 after surgery, with coughing between DEX Group and CTRL group||0|0|0.378
72350608|NCT02267538|144221709|OTHER||Median Difference (Final Values)|0.0||||0.777|TWO_SIDED|95.0|0.0|0.0|||Wilcoxon (Mann-Whitney)|||this statistical analysis applies to the first row in Outcome 5, i.e., subjective sleep quality in Day 1 after surgery, between DEX Group and CTRL group||0|0|0.777
72350609|NCT02267538|144221709|OTHER||Median Difference (Final Values)|0.0||||0.919|TWO_SIDED|95.0|-1.0|1.0|||Wilcoxon (Mann-Whitney)|||this statistical analysis applies to the second row in Outcome 5, i.e., subjective sleep quality in Day 2 after surgery, between DEX Group and CTRL group||1|-1|0.919
72350610|NCT02267538|144221709|OTHER||Median Difference (Final Values)|0.0||||0.835|TWO_SIDED|95.0|0.0|0.0|||Wilcoxon (Mann-Whitney)|||this statistical analysis applies to the third row in Outcome 5, i.e., subjective sleep quality in Day 3 after surgery, between DEX Group and CTRL group||0|0|0.835
72350611|NCT02267538|144221709|OTHER||Median Difference (Final Values)|0.0||||0.321|TWO_SIDED|95.0|0.0|0.0|||Wilcoxon (Mann-Whitney)|||this statistical analysis applies to the fourth row in Outcome 5, i.e., subjective sleep quality in Day 4 after surgery, between DEX Group and CTRL group||0|0|0.321
72350612|NCT02267538|144221709|OTHER||Median Difference (Final Values)|0.0||||0.174|TWO_SIDED|95.0|0.0|0.0|||Wilcoxon (Mann-Whitney)|||this statistical analysis applies to the fifth row in Outcome 5, i.e., subjective sleep quality in Day 5 after surgery, between DEX Group and CTRL group||0|0|0.174
72350613|NCT02267538|144221710|OTHER||Hazard Ratio (HR)|1.03||||0.788|TWO_SIDED|95.0|0.82|1.31|||Log Rank|||||1.31|0.82|0.788
72350614|NCT02267538|144221711|OTHER||Hazard Ratio (HR)|0.97||||0.826|TWO_SIDED|95.0|0.77|1.23|||Log Rank|||||1.23|0.77|0.826
72350615|NCT03152591|144221752|OTHER||Ratio LIK066/Placebo|0.88||||0.353|TWO_SIDED|90.0|0.7|1.11|||t-test, 2 sided|Two-sided test at the 0.1 significance level|||Log transformed ratio of Day 15 to baseline in average fasting free testosterone was analyzed using an analysis of covariance model which included treatment as a categorical factor, baseline body weight and log transformed baseline average fasting free testosterone as a covariate.|1.11|0.70|0.353
72350616|NCT03152591|144221753|OTHER||Ratio LIK066/Placebo|1.25||||0.218|TWO_SIDED|90.0|0.92|1.68|||t-test, 2 sided|Two-sided test at the 0.1 significance level|||Log transformed ratio of Day 15 to baseline was analyzed using an analysis of covariance model which will include treatment as a categorical factor and log transformed baseline as a covariate.|1.68|0.92|0.218
72350617|NCT03152591|144221754|OTHER||Ratio LIK066/Placebo|1.27||||0.249|TWO_SIDED|90.0|0.9|1.78|||t-test, 2 sided|Two-sided test at the 0.1 significance level|||Log transformed ratio of Day 15 to baseline was analyzed using an analysis of covariance model which will include treatment as a categorical factor and log transformed baseline as a covariate.|1.78|0.90|0.249
72350618|NCT03152591|144221755|OTHER||Ratio LIK066/Placebo|1.15||||0.173|TWO_SIDED|90.0|0.97|1.36|||t-test, 2 sided|Two-sided test at the 0.1 significance level|Values \< LLOQ and values \> ULOQ are imputed as LLOQ/2 and ULOQ respectively.||Log transformed ratio of Day 15 to baseline was analyzed using an analysis of covariance model which will include treatment as a categorical factor and log transformed baseline as a covariate.|1.36|0.97|0.173
72350619|NCT03152591|144221756|OTHER||Ratio LIK066/Placebo|0.82||||0.089|TWO_SIDED|90.0|0.68|0.99|||t-test, 2 sided|Two-sided test at the 0.1 significance level|Values \< LLOQ and values \> ULOQ are imputed as LLOQ/2 and ULOQ respectively||Log transformed ratio of Day 15 to baseline was analyzed using an analysis of covariance model which will include treatment as a categorical factor and log transformed baseline as a covariate.|0.99|0.68|0.089
72350620|NCT03152591|144221757|OTHER||Ration LIK066/Placebo|0.69||||0.109|TWO_SIDED|90.0|0.48|1.01|||t-test, 2 sided|Two-sided test at the 0.1 significance level|Values \< LLOQ and values \> ULOQ are imputed as LLOQ/2 and ULOQ respectively.||Log transformed ratio of Day 15 to baseline was analyzed using an analysis of covariance model which will include treatment as a categorical factor and log transformed baseline as a covariate.|1.01|0.48|0.109
72350621|NCT03152591|144221758|OTHER||Ration LIK066/Placebo|0.76||||0.008|TWO_SIDED|90.0|0.65|0.89|||t-test, 2 sided|Two-sided test at the 0.1 significance level|Values \< LLOQ and values \> ULOQ are imputed as LLOQ/2 and ULOQ respectively.||Log transformed ratio of Day 15 to baseline was analyzed using an analysis of covariance model which will include treatment as a categorical factor and log transformed baseline as a covariate.|0.89|0.65|0.008
72350622|NCT03152591|144221759|OTHER||Ratio LIK066/Placebo|0.91||||0.34|TWO_SIDED|90.0|0.77|1.07|||t-test, 2 sided|Two-sided test at the 0.1 significance level|||Log transformed ratio of Day 15 to baseline was analyzed using an analysis of covariance model which will include treatment as a categorical factor and log transformed baseline as a covariate.|1.07|0.77|0.340
72350623|NCT03152591|144221760|OTHER||Ratio LIK066/Placebo|0.79||||0.204|TWO_SIDED|90.0|0.58|1.08|||t-test, 2 sided|Two-sided test at the 0.1 significance level|Values \< LLOQ and values \> ULOQ are imputed as LLOQ/2 and ULOQ respectively.||Log transformed ratio of Day 15 to baseline was analyzed using an analysis of covariance model which will include treatment as a categorical factor and log transformed baseline as a covariate.|1.08|0.58|0.204
72350624|NCT03868254|144221789|OTHER||||||<|0.0001|||||||Paired t-test|||||||<.0001
72350625|NCT03868254|144221789|OTHER||||||<|0.0001|||||||Paired t-test|||||||<.0001
72350626|NCT03868254|144221790|OTHER||||||<|0.0001|||||||Paired t-test|||||||<.0001
72350627|NCT03868254|144221790|OTHER|||||||0.0001|||||||Paired t-test|||||||0.0001
72350628|NCT03868254|144221791|OTHER|||||||0.003|||||||Paired t-test|||||||0.0030
72350629|NCT03868254|144221791|OTHER|||||||0.0018|||||||Paired t-test|||||||0.0018
72350630|NCT03868254|144221792|OTHER|||||||0.0053|||||||Paired t-test|||||||0.0053
72350631|NCT03868254|144221792|OTHER|||||||0.0472|||||||Paired t-test|||||||0.0472
72350632|NCT02848222|144221798|SUPERIORITY|||||||0.02||||||Threshold for significance was p \< 0.05|ANOVA|||||||0.02
72350633|NCT02871635|144221804|OTHER||Risk Ratio (RR)|0.945|||||TWO_SIDED|90.0|0.87|1.028|||||BI 695501 as numerator Humira EU as denominator|Was analyzed using a log-linked binomial model, described as: response to treatment at Week 4 = treatment+prior infliximab exposure+screening Simple Endoscopic Score for Crohn's Disease (SES-CD)||1.028|0.870|
72350634|NCT02871635|144221804|OTHER||Risk Ratio (RR)|0.945|||||TWO_SIDED|95.0|0.856|1.044|||||BI 695501 as numerator Humira EU as denominator|Was to be analyzed using a log-linked binomial model, described as: response to treatment at Week 4 = treatment+prior infliximab exposure+screening Simple Endoscopic Score for Crohn's Disease (SES-CD)||1.044|0.856|
72350635|NCT02871635|144221805|OTHER||Risk Ratio (RR)|1.0|||||TWO_SIDED|90.0|0.871|1.148|||||BI 695501 as numerator Humira EU as denominator|Was to be analyzed using a log-linked binomial model, described as: response to treatment at Week 24 = treatment+prior infliximab exposure+screening Simple Endoscopic Score for Crohn's Disease (SES-CD)||1.148|0.871|
72350636|NCT02871635|144221805|OTHER||Risk Ratio (RR)|1.0|||||TWO_SIDED|95.0|0.848|1.178|||||BI 695501 as numerator Humira EU as denominator|Was to be analyzed using a log-linked binomial model, described as: response to treatment at Week 24 = treatment+prior infliximab exposure+screening Simple Endoscopic Score for Crohn's Disease (SES-CD)||1.178|0.848|
72350637|NCT02871635|144221806|OTHER||Risk Ratio (RR)|0.9|||||TWO_SIDED|90.0|0.751|1.078|||||BI 695501 as numerator Humira EU as denominator|Was to be analyzed using a log-linked binomial model, described as: response to treatment at Week 24 = treatment+prior infliximab exposure+screening Simple Endoscopic Score for Crohn's Disease (SES-CD)||1.078|0.751|
72350638|NCT02871635|144221806|OTHER||Risk Ratio (RR)|0.9|||||TWO_SIDED|95.0|0.725|1.116|||||BI 695501 as numerator Humira EU as denominator|Was to be analyzed using a log-linked binomial model, described as: response to treatment at Week 24 = treatment+prior infliximab exposure+screening Simple Endoscopic Score for Crohn's Disease (SES-CD)||1.116|0.725|
72350639|NCT02968368|144221821|SUPERIORITY||Mean Difference (Final Values)|0.52|STANDARD_ERROR_OF_MEAN|0.21||0.0149|TWO_SIDED|95.0|0.102|0.93|||ANCOVA|||||0.930|0.102|0.0149
72350640|NCT02968368|144221826|SUPERIORITY||Mean Difference (Final Values)|39.03|STANDARD_ERROR_OF_MEAN|11.097||0.0006|TWO_SIDED|95.0|17.07|60.992|||ANCOVA|||||60.992|17.070|0.0006
72350641|NCT02968368|144221829|SUPERIORITY||Mean Difference (Final Values)|4.46|STANDARD_ERROR_OF_MEAN|1.282||0.0007|TWO_SIDED|95.0|1.928|7.001|||ANCOVA|||||7.001|1.928|0.0007
72350642|NCT02968368|144221830|SUPERIORITY||Mean Difference (Final Values)|1.86|STANDARD_ERROR_OF_MEAN|0.708||0.0098|TWO_SIDED|95.0|0.457|3.261|||ANCOVA|||||3.261|0.457|0.0098
72350643|NCT00991939|144221833|SUPERIORITY_OR_OTHER||Difference of proportions|0.0|STANDARD_ERROR_OF_MEAN|0.58||1|TWO_SIDED|95.0|-0.975|0.708|||Fisher Exact||The estimated value is the proportion of success in the high dose pulse dexamethasone group minus the proportion of success in the standard prednisone group.|Four subjects were not included in this analysis because not enough data was available to assess the primary outcome at the time the study was terminated.||0.708|-0.975|1.00
72350644|NCT00123123|144221870|SUPERIORITY_OR_OTHER_LEGACY|||||||0.675||95.0|||||ANOVA|||A mixed effect model was used to compare overall treatment effects between groups for repeated measures data. The group comparison for each time point was performed using ANOVA.||||0.6750
72350645|NCT02073682|144221878|NON_INFERIORITY|Edoxaban Group was considered non-inferior to the Dalteparin Group if the upper limit of the 2-sided 95% confidence interval (CI) for the Hazard Ratio (\[LMW\] Edoxaban Group to Dalteparin Group) was less than 1.5.|Cox Proportional Hazard|0.97||||0.0056|TWO_SIDED|95.0|0.696|1.359|||Cox proportional hazard|||||1.359|0.696|0.0056
72350646|NCT02073682|144221878|SUPERIORITY|The hazard ratio (HR), two-sided confidence interval (CI) and p-value are based on the Cox proportional hazard model including treatment and the two stratification factors as covariates: the dichotomized bleeding risk and the dichotomized dose-adjustment factor.||||||0.8712|||||||Cox proportional hazard|||||||0.8712
72350647|NCT02073682|144221879|SUPERIORITY||Hazard Ratio (HR)|2.0||||0.0254|TWO_SIDED|95.0|1.089|3.657|||Regression, Cox|||The HR, 2-sided CI and p-value are based on the Cox regression model with counting process approach for on-treatment including treatment and the 2 stratification factors as covariates: the dichotomized bleeding risk and the dichotomized dose-adjustment factor.||3.657|1.089|0.0254
72350648|NCT02073682|144221880|SUPERIORITY||Cox Proportional Hazard|0.71||||0.0931|TWO_SIDED|95.0|0.476|1.059|||Cox proportional hazard|||The HR, 2-sided CI, and p-value are based on the Cox proportional hazard model including treatment and the 2 stratification factors as covariates: the dichotomized bleeding risk and the dichotomized dose-adjustment factor.||1.059|0.476|0.0931
72350649|NCT02073682|144221881|SUPERIORITY||Cox Proportional Hazard|0.56||||0.0394|TWO_SIDED|95.0|0.318|0.972|||Cox proportional hazard|||The HR, 2-sided CI, and p-value are based on the Cox proportional hazard model including treatment and the 2 stratification factors as covariates: the dichotomized bleeding risk and the dichotomized dose-adjustment factor.||0.972|0.318|0.0394
72350650|NCT02073682|144221882|SUPERIORITY||Cox Proportional Hazard|0.9||||0.7324|TWO_SIDED|95.0|0.502|1.624|||Cox proportional hazard|||The HR, 2-sided CI, and p-value are based on the Cox proportional hazard model including treatment and the 2 stratification factors as covariates: the dichotomized bleeding risk and the dichotomized dose-adjustment factor.||1.624|0.502|0.7324
72350651|NCT02073682|144221883|SUPERIORITY||Cox Proportional Hazard|1.56||||0.4873|TWO_SIDED|95.0|0.444|5.505|||Cox proportional hazard|||The HR, 2-sided CI, and p-value are based on the Cox proportional hazard model including treatment and the 2 stratification factors as covariates: the dichotomized bleeding risk and the dichotomized dose-adjustment factor.||5.505|0.444|0.4873
72350652|NCT02073682|144221884|SUPERIORITY||Cox Proportional Hazard|1.08||||0.4199|TWO_SIDED|95.0|0.898|1.293|||Cox proportional hazard|||The HR, 2-sided CI, and p-value are based on the Cox proportional hazard model including treatment and the 2 stratification factors as covariates: the dichotomized bleeding risk and the dichotomized dose-adjustment factor.||1.293|0.898|0.4199
72350653|NCT00855816|144221892|SUPERIORITY_OR_OTHER|||||||0.27|TWO_SIDED|||||A priori threshold for significance: p\<.05.|Mixed Models Analysis|Mixed model based on intent to treat sample.||Null hypothesis: there will be no differences in PTSD hyperarousal symptom changes in individuals who did receive the experimental intervention vs. those who did not .||||.27
72350654|NCT03393494|144221893|EQUIVALENCE|provides 85% power of success|Equivalence ratio|107.0|||||TWO_SIDED|90.0|97.8|112.2|||Fieller's method|||||112.2|97.8|
72350655|NCT03393494|144221894|EQUIVALENCE|provides 85% power of success|Equivalence ratio|104.0||||0.05|TWO_SIDED|90.0|94.1|108.5|||Fieller's method|||||108.5|94.1|0.05
72350656|NCT01965704|144221895|OTHER|||||||0.2|||||||Fisher Exact|||||||0.2
72350657|NCT01965704|144221896|OTHER||Mean Difference (Final Values)|-1.9||||0.56|TWO_SIDED|95.0|-8.0|4.3|||Wilcoxon Rank-Sum test||The 95% confidence interval between the ondansetron group and the placebo group was calculated with the use of Hodges-Lehmann estimator.|Difference in overall length of stay.||4.3|-8.0|0.56
72350658|NCT01965704|144221896|OTHER||Median Difference (Final Values)|-1.9||||0.07|TWO_SIDED|95.0|-4.0|0.2|||Wilcoxon Rank-Sum test||The 95% confidence interval between the ondansetron group and the placebo group was calculated with the use of Hodges-Lehmann estimator.|Difference in length of stay as calculated with maximum length capped at 15 days.||0.2|-4.0|0.07
72350659|NCT01965704|144221897|OTHER||Mean Difference (Final Values)|-1.8||||0.31|TWO_SIDED|95.0|-8.8|2.7|||Wilcoxon Rank-Sum test||The 95% confidence interval between the ondansetron group and the placebo group was calculated with the use of Hodges-Lehmann estimator.|||2.7|-8.8|0.31
72350660|NCT01526213|144221901|SUPERIORITY_OR_OTHER||Geometric Mean AUC Ratio (GFJ/mGFJ)|0.96||||0.78|TWO_SIDED|90.0|0.4|1.5|||t-test, 2 sided|||For juice comparisons, fexofenadine + furanocoumarin-free grapefruit juice will be the test agent (numerator) and fexofenadine + grapefruit juice will be the reference standard (denominator).||1.5|0.4|0.78
72350661|NCT00413218|144221924|NON_INFERIORITY|The lower bound of the 95% CI for the adjusted treatment difference was compared to the protocol prespecified noninferiority margin (NIM) value of -15%. If the lower bound were greater than -15%, isavuconazole would be declared as noninferior to caspofungin.|Adjusted Treatment Difference (%)|-10.8|||||TWO_SIDED|95.0|-19.9|-1.8|||||The 95% CI for the adjusted treatment difference was calculated based on a normal approximation.|The adjusted treatment difference (ISA-CAS) was calculated by a stratified Cochran-Mantel-Haenszel (CMH) method with the strata of geographical region and baseline neutropenic status.||-1.8|-19.9|
72350662|NCT00413218|144221925|OTHER||Adjusted Treatment Difference (%)|-2.7|||||TWO_SIDED|95.0|-12.2|6.8|||||The 95% CI for the adjusted treatment difference was calculated based on a normal approximation.|The adjusted treatment difference (ISA-CAS) was calculated by a stratified CMH method with the strata of geographical region and baseline neutropenic status.||6.8|-12.2|
72350663|NCT00413218|144221926|OTHER||Adjusted Treatment Difference %|-10.9|||||TWO_SIDED|95.0|-19.9|-1.9|||||The 95% CI for the adjusted treatment difference was calculated based on a normal approximation.|Statistical analysis of adjusted treatment difference (ISA-CAS) at EOT (Day 56). The adjusted treatment difference (ISA-CAS) was calculated by a stratified CMH method with the strata of geographical region and baseline neutropenic status.||-1.9|-19.9|
72350664|NCT00413218|144221926|OTHER||Adjusted Treatment Difference %|-5.4|||||TWO_SIDED|95.0|-15.0|4.2|||||The 95% CI for the adjusted treatment difference was calculated based on a normal approximation.|Statistical analysis of adjusted treatment difference (ISA-CAS) at FU2 (6 weeks after end of treatment). The adjusted treatment difference (ISA-CAS) was calculated by a stratified CMH method with the strata of geographical region and baseline neutropenic status.||4.2|-15.00|
72350665|NCT00413218|144221927|OTHER||Adjusted Treatment Difference (%)|-8.2|||||TWO_SIDED|95.0|-15.4|-0.9|||||The 95% CI for the adjusted treatment difference was calculated based on a normal approximation.|Statistical analysis of adjusted treatment difference (ISA-CAS) at EOIV (Days 11-56).The adjusted treatment difference (ISA-CAS) was calculated by a stratified CMH method with the strata of geographical region and baseline neutropenic status.||-0.9|-15.4|
72350666|NCT00413218|144221927|OTHER||Adjusted Treatment Difference (%)|-8.6|||||TWO_SIDED|95.0|-15.8|-1.5|||||The 95% CI for the adjusted treatment difference was calculated based on a normal approximation.|Statistical analysis of adjusted treatment difference (ISA-CAS) at EOT (Day 56). The adjusted treatment difference (ISA-CAS) was calculated by a stratified CMH method with the strata of geographical region and baseline neutropenic status.||-1.5|-15.8|
72350667|NCT00413218|144221927|OTHER||Adjusted Treatment Difference (%)|-0.4|||||TWO_SIDED|95.0|-9.1|8.3|||||The 95% CI for the adjusted treatment difference was calculated based on a normal approximation.|Statistical analysis of adjusted treatment difference (ISA-CAS) at FU1 (2 weeks after end of treatment). The adjusted treatment difference (ISA-CAS) was calculated by a stratified CMH method with the strata of geographical region and baseline neutropenic status.||8.3|-9.1|
72350668|NCT00413218|144221927|OTHER||Adjusted Treatment Difference (%)|-5.8|||||TWO_SIDED|95.0|-15.3|3.6|||||The 95% CI for the adjusted treatment difference was calculated based on a normal approximation.|Statistical analysis of adjusted treatment difference (ISA-CAS) at FU2 (6 weeks after end of treatment).The adjusted treatment difference (ISA-CAS) was calculated by a stratified CMH method with the strata of geographical region and baseline neutropenic status.||3.6|-15.3|
72350669|NCT00413218|144221928|OTHER||Adjusted Treatment Difference (%)|-14.9|||||TWO_SIDED|95.0|-22.7|-7.0|||||The 95% CI for the adjusted treatment difference was calculated based on a normal approximation.|Statistical analysis of adjusted treatment difference (ISA-CAS) at EOIV (Days 11-56). The adjusted treatment difference (ISA-CAS) was calculated by a stratified CMH method with the strata of geographical region and baseline neutropenic status.||-7.0|-22.7|
72350670|NCT00413218|144221928|OTHER||Adjusted Treatment Difference (%)|-15.9|||||TWO_SIDED|95.0|-23.5|-8.4|||||The 95% CI for the adjusted treatment difference was calculated based on a normal approximation.|Statistical analysis of adjusted treatment difference (ISA-CAS) at EOT (Day 56). The adjusted treatment difference (ISA-CAS) was calculated by a stratified CMH method with the strata of geographical region and baseline neutropenic status.||-8.4|-23.5|
72350671|NCT00413218|144221928|OTHER||Adjusted Treatment Difference (%)|-0.7|||||TWO_SIDED|95.0|-8.1|9.6|||||The 95% CI for the adjusted treatment difference was calculated based on a normal approximation.|Statistical analysis of adjusted treatment difference (ISA-CAS) at FU1 (2 weeks after end of treatment).The adjusted treatment difference (ISA-CAS) was calculated by a stratified CMH method with the strata of geographical region and baseline neutropenic status.||9.6|-8.1|
72350672|NCT00413218|144221928|OTHER||Adjusted Treatment Difference (%)|-5.2|||||TWO_SIDED|95.0|-14.7|4.3|||||The 95% CI for the adjusted treatment difference was calculated based on a normal approximation.|Statistical analysis of adjusted treatment difference (ISA-CAS) at FU2 (6 weeks after end of treatment).The adjusted treatment difference (ISA-CAS) was calculated by a stratified CMH method with the strata of geographical region and baseline neutropenic status.||4.3|-14.7|
72350673|NCT00413218|144221929|OTHER||Adjusted Treatment Difference (%)|-11.4|||||TWO_SIDED|95.0|-20.4|-2.5|||||The 95% CI for the adjusted treatment difference was calculated based on a normal approximation.|Statistical analysis of adjusted treatment difference (ISA-CAS) at Day 7. The adjusted treatment difference (ISA-CAS) was calculated by a stratified CMH method with the strata of geographical region and baseline neutropenic status.||-2.5|-20.4|
72350674|NCT00413218|144221929|OTHER||Adjusted Treatment Difference (%)|-8.5|||||TWO_SIDED|95.0|-16.5|-0.4|||||The 95% CI for the adjusted treatment difference was calculated based on a normal approximation.|Statistical analysis of adjusted treatment difference (ISA-CAS) at EOT (Day 56). The adjusted treatment difference (ISA-CAS) was calculated by a stratified CMH method with the strata of geographical region and baseline neutropenic status.||-0.4|-16.5|
72350675|NCT00413218|144221930|OTHER||Adjusted Treatment Difference (%)|-11.1|||||TWO_SIDED|95.0|-20.3|-1.9|||||The 95% CI for the adjusted treatment difference was calculated based on a normal approximation.|Statistical analysis of adjusted treatment difference (ISA-CAS) at Day 7. The adjusted treatment difference (ISA-CAS) was calculated by a stratified CMH method with the strata of geographical region and baseline neutropenic status.||-1.9|-20.3|
72350676|NCT00413218|144221930|OTHER||Adjusted Treatment Difference (%)|-8.1|||||TWO_SIDED|95.0|-16.3|0.1|||||The 95% CI for the adjusted treatment difference was calculated based on a normal approximation.|Statistical analysis of adjusted treatment difference (ISA-CAS) at EOT (Day 56). The adjusted treatment difference (ISA-CAS) was calculated by a stratified CMH method with the strata of geographical region and baseline neutropenic status.||0.1|-16.3|
72350677|NCT00413218|144221931|OTHER||Adjusted Treatment Difference (%)|2.5|||||TWO_SIDED|95.0|-3.8|8.9||||||Statistical analysis of all-cause mortality on Day 14. Adjusted treatment difference (Isavuconazole-Caspofungin) is calculated by a stratified CMH method with the strata of geographical regions, and baseline neutropenic status.||8.9|-3.8|
72350678|NCT00413218|144221931|OTHER||Adjusted Treatment Difference (%)|1.4|||||TWO_SIDED|95.0|-7.1|10.0||||||Statistical analysis of all-cause mortality on Day 56. Adjusted treatment difference (Isavuconazole-Caspofungin) is calculated by a stratified CMH method with the strata of geographical regions, and baseline neutropenic status.||10.0|-7.1|
72350679|NCT01687296|144221965|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was demonstrated at the lower limit of the 95% confidence interval (5%, 2-sided significance level) for the treatment difference (FP minus prednisone) in the mean morning PEF on diary card over the treatment assessment period was greater than -12L/min.|Mean Difference (Final Values)|0.46||||0.931|TWO_SIDED|95.0|-9.85|10.76|||ANCOVA|||250 par were to be enrolled to achieve 200 total evaluable par or 100 evaluable par per group. Sample size was based on the primary efficacy endpoint (AM PEF) and had 80% power to reject the null hypothesis: nebulized FP (1 mg BID) was inferior to oral prednisone with regard to AM PEF using one-side t test at significance level 2.5%, and assuming true treatment difference (FP minus predisone) was 3.6 L/min, noninferiority margin was -12L/min, and common standard deviation was 39 L/min.||10.76|-9.85|0.931
72350680|NCT01687296|144221966|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was demonstrated at the lower limit of the 95% confidence interval (5%, 2-sided significance level) for the treatment difference (FP minus prednisone) in the mean morning PEF on diary card over the treatment assessment period was greater than -12L/min.|Mean Difference (Final Values)|0.5||||0.922|TWO_SIDED|95.0|-9.64|10.65|||ANCOVA|||||10.65|-9.64|0.922
72350681|NCT01687296|144221967|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.16||||0.822|TWO_SIDED|95.0|-9.02|11.34|||ANCOVA|||||11.34|-9.02|0.822
72350682|NCT01687296|144221968|SUPERIORITY_OR_OTHER|||||||0.717||95.0|||||Wilcoxon rank sum test|||Fluticasone propionate versus Prednisone for day-time symptom score||||0.717
72350683|NCT01687296|144221968|SUPERIORITY_OR_OTHER|||||||0.683||95.0|||||Wilcoxon rank sum test|||Fluticasone propionate versus Prednisone for night-time symptom score||||0.683
72350684|NCT01687296|144221969|SUPERIORITY_OR_OTHER|||||||0.996||95.0|||||Wilcoxon rank sum test|||||||0.996
72350685|NCT01687296|144221970|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.044||||0.348|TWO_SIDED|95.0|-0.135|0.048|||ANCOVA|||Fluticasone propionate versus Prednisone for FEV1 on Day 5||0.048|-0.135|0.348
72350686|NCT01687296|144221970|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.004||||0.914|TWO_SIDED|95.0|-0.074|0.083|||ANCOVA|||Fluticasone propionate versus Prednisone for FEV1 on Day 8||0.083|-0.074|0.914
72350687|NCT01687296|144221970|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.067||||0.276|TWO_SIDED|95.0|-0.187|0.054|||ANCOVA|||Fluticasone propionate versus Prednisone for FVC on Day 5||0.054|-0.187|0.276
72350688|NCT01687296|144221970|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.039||||0.384|TWO_SIDED|95.0|-0.126|0.049|||ANCOVA|||Fluticasone propionate versus Prednisone for FVC on Day 8||0.049|-0.126|0.384
72350689|NCT01687296|144221971|SUPERIORITY_OR_OTHER|||||||0.507||95.0|||||Wilcoxon rank sum test|||Fluticasone propionate versus Prednisone for clinical scoring index on Day 5||||0.507
72350690|NCT01687296|144221971|SUPERIORITY_OR_OTHER|||||||0.7||95.0|||||Wilcoxon rank sum test|||Fluticasone propionate versus Prednisone for clinical scoring index on Day 8||||0.700
72350691|NCT01687296|144221972|SUPERIORITY_OR_OTHER|||||||0.633||95.0|||||Wilcoxon rank sum test|||Fluticasone propionate versus Prednisone for participant/parent global evaluation||||0.633
72350692|NCT01687296|144221972|SUPERIORITY_OR_OTHER|||||||0.323||95.0|||||Wilcoxon rank sum test|||Fluticasone propionate versus Prednisone for investigator global evaluation||||0.323
72350693|NCT00799903|144221989|SUPERIORITY||Hazard Ratio (HR)|0.94||||0.199|TWO_SIDED|95.1|0.85|1.03||Hazard ratio and p-value are estimated using a Cox proportional hazard regression model with treatment as the only covariate. A hazard ratio \< 1 indicates a lower risk with this treatment compared to Placebo.|Regression, Cox|||||1.03|0.85|0.199
72350694|NCT00799903|144221990|SUPERIORITY||Hazard Ratio (HR)|0.9||||0.045|TWO_SIDED|95.0|0.82|1.0||Hazard ratio and p-value are estimated using a Cox proportional hazard regression model with treatment as the only covariate. A hazard ratio \< 1 indicates a lower risk with this treatment compared to Placebo.|Regression, Cox|||||1.00|0.82|0.045
72350695|NCT00799903|144221991|SUPERIORITY||Hazard Ratio (HR)|0.91||||0.019|TWO_SIDED|95.0|0.84|0.98||Hazard ratio and p-value are estimated using a Cox proportional hazard regression model with treatment as the only covariate. A hazard ratio \< 1 indicates a lower risk with this treatment compared to Placebo.|Regression, Cox|||||0.98|0.84|0.019
72350696|NCT00799903|144221992|SUPERIORITY||Hazard Ratio (HR)|0.96||||0.594|TWO_SIDED|95.0|0.83|1.11||Hazard ratio and p-value are estimated using a Cox proportional hazard regression model with treatment as the only covariate. A hazard ratio \< 1 indicates a lower risk with this treatment compared to Placebo.|Regression, Cox|||||1.11|0.83|0.594
72350697|NCT00799903|144221993|SUPERIORITY||Hazard Ratio (HR)|0.89||||0.108|TWO_SIDED|95.0|0.77|1.03||Hazard ratio and p-value are estimated using a Cox proportional hazard regression model with treatment as the only covariate. A hazard ratio \< 1 indicates a lower risk with this treatment compared to Placebo.|Regression, Cox|||||1.03|0.77|0.108
72350698|NCT00799903|144221994|SUPERIORITY||Hazard Ratio (HR)|1.01||||0.92|TWO_SIDED|95.0|0.81|1.27||Hazard ratio and p-value are estimated using a Cox proportional hazard regression model with treatment as the only covariate. A hazard ratio \< 1 indicates a lower risk with this treatment compared to Placebo.|Regression, Cox|||||1.27|0.81|0.920
72350699|NCT00799903|144221995|SUPERIORITY||Hazard Ratio (HR)|0.96||||0.397|TWO_SIDED|95.0|0.88|1.05||Hazard ratio and p-value are estimated using a Cox proportional hazard regression model with treatment as the only covariate. A hazard ratio \< 1 indicates a lower risk with this treatment compared to Placebo.|Regression, Cox|||||1.05|0.88|0.397
72350700|NCT00799903|144221996|SUPERIORITY||Hazard Ratio (HR)|1.01||||0.87|TWO_SIDED|95.0|0.9|1.13||Hazard ratio and p-value are estimated using a Cox proportional hazard regression model with treatment as the only covariate. A hazard ratio \< 1 indicates a lower risk with this treatment compared to Placebo.|Regression, Cox|||||1.13|0.90|0.870
72350701|NCT01219985|144222002|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||McNemar|||We performed a McNemar test to compare the sensitivities obtained for each PET image method||||<0.001
72350702|NCT01219985|144222003|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||The null hypothesis was : lesions' SUVmax are equivalent with our without application of the CT-Based respiratory-gated PET method.||||<0.001
72350703|NCT00596752|144222004|SUPERIORITY_OR_OTHER|||||||0.2587||||||For confirmatory hypothesis testing the p-values of the normal approximation test for comparing two rates was used as input for the weighted inverse normal method. The 1-sided boundary p-value for stage 1 is given by p1=0.00587.|Cochran-Mantel-Haenszel|The 2 primary endpoints were tested at one-sided 0.0125 each so that the overall type I error rate of 0.025 was controlled in a strong sense.||"Primary goal was to test the following null hypothesis:~H01: πhealingPGE1≤ πhealingPlacebo, with πhealing=proportion of subjects with complete ulcer healing. The planned information rate for stage 1 of the two-stage group sequential test design with an overall one-sided comparison-wise α=0.0125 for this co-primary endpoint is given by 0.83.~This is the statistical analysis of stage 1."||||0.2587
72350704|NCT00596752|144222004|SUPERIORITY_OR_OTHER|||||||0.3463||||||For confirmatory hypothesis testing the p-values of the normal approximation test for comparing two rates was used as input for the weighted inverse normal method. The 1-sided boundary p-value for stage 1 and 2 combined is given by p2=0.01085.|Cochran-Mantel-Haenszel|The 2 primary endpoints were tested at one-sided 0.0125 each so that the overall type I error rate of 0.025 was controlled in a strong sense.||"Primary goal was to test the following null hypothesis:~H01: πhealingPGE1≤ πhealingPlacebo, with πhealing=proportion of subjects with complete ulcer healing.~This is the statistical analysis of stage 1 and stage 2 combined."||||0.3463
72350705|NCT00596752|144222005|SUPERIORITY_OR_OTHER|||||||0.0173||||||For confirmatory hypothesis testing the p-values of the normal approximation test for comparing two rates was used as input for the weighted inverse normal method. The 1-sided boundary p-value for stage 1 is given by p1=0.00587.|Cochran-Mantel-Haenszel|The 2 primary endpoints were tested at one-sided 0.0125 each so that the overall type I error rate of 0.025 was controlled in a strong sense.||"Primary goal was to test the following null hypothesis:~H02: πampPGE1≥ πampPlacebo, with πamp=proportion of subjects with major amputations.~The planned information rate for stage 1 of the two-stage group sequential test design with an overall one-sided comparison-wise α=0.0125 for this co-primary endpoint is given by 0.83.~This is the statistical analysis of stage 1."||||0.0173
72350706|NCT00596752|144222005|SUPERIORITY_OR_OTHER|||||||0.1154||||||For confirmatory hypothesis testing the p-values of the normal approximation test for comparing two rates was used as input for the weighted inverse normal method. The 1-sided boundary p-value for stage 1 and 2 combined is given by p2=0.01085.|Cochran-Mantel-Haenszel|The 2 primary endpoints were tested at one-sided 0.0125 each so that the overall type I error rate of 0.025 was controlled in a strong sense.||"Primary goal was to test the following null hypothesis:~H02: πampPGE1≥ πampPlacebo, with πamp=proportion of subjects with major amputations.~This is the statistical analysis of stage 1 and stage 2 combined."||||0.1154
72350707|NCT04797780|144222016|SUPERIORITY||Difference in CR Rate|5.06||||0.2084|TWO_SIDED|95.0|-7.1|17.2|||Cochran-Mantel-Haenszel|||||17.2|-7.1|0.2084
72350708|NCT02940496|144222034|SUPERIORITY||Correlation Coefficient (2 sided test)|0.081||||0.008|TWO_SIDED||||||t-test, 2 sided|||||||0.008
72350709|NCT02940496|144222035|SUPERIORITY||Correlation Coefficient (2-sided test)|0.88||||0.009|TWO_SIDED||||||t-test, 2 sided|||||||0.009
72350710|NCT02940496|144222036|SUPERIORITY||Correlation Coefficient (2-sided test)|0.79||||0.01|TWO_SIDED||||||t-test, 2 sided|||||||0.01
72350711|NCT01895946|144222057|SUPERIORITY_OR_OTHER||Least square mean difference (LSM)|1.02|||||TWO_SIDED|90.0|0.86|1.2|||Mixed Models Analysis|||||1.20|0.86|
72350712|NCT01895946|144222057|SUPERIORITY_OR_OTHER||Least square means difference (LSM)|0.67|||||TWO_SIDED|90.0|0.55|0.82|||Mixed Models Analysis|||||0.82|0.55|
72350713|NCT01895946|144222058|SUPERIORITY_OR_OTHER||Least square means difference (LSM)|0.9|||||TWO_SIDED|90.0|0.77|1.06|||Mixed Models Analysis|||||1.06|0.77|
72350714|NCT01895946|144222058|SUPERIORITY_OR_OTHER||Least square means difference (LSM)|0.89|||||TWO_SIDED|90.0|0.76|1.05|||Mixed Models Analysis|||||1.05|0.76|
72350715|NCT03089541|144222068|SUPERIORITY||Odds Ratio (OR)|0.17||||0.002|TWO_SIDED|95.0|0.06|0.52|||Regression, Logistic|||Comparison on Eating/Drinking using a model adjusted for timing of the assessment (weekend, time of day (am vs. pm), and day of study (1 to 7). The significance level was 0.05.||0.52|0.06|0.002
72350716|NCT03089541|144222068|SUPERIORITY||Odds Ratio (OR)|2.65||||0.07|TWO_SIDED|95.0|0.92|7.65|||Regression, Logistic|||Comparison on Traveling using a model adjusted for timing of the assessment (weekend, time of day (am vs. pm), and day of study (1 to 7)). The significance level was 0.05.||7.65|0.92|0.07
72350717|NCT03089541|144222068|SUPERIORITY||Odds Ratio (OR)|1.46||||0.4|TWO_SIDED|95.0|0.59|3.64|||Regression, Logistic|||Comparison on Working/Reading/Studying using a model adjusted for timing of the assessment (weekend, time of day (am vs. pm), and day of study (1 to 7). The significance level was 0.05.||3.64|0.59|0.40
72350718|NCT03089541|144222068|SUPERIORITY||Odds Ratio (OR)|1.34||||0.6|TWO_SIDED|95.0|0.51|3.53|||Regression, Logistic|||Comparison on Socializing using a model adjusted for timing of the assessment (weekend, time of day (am vs. pm), and day of study (1 to 7). The significance level was 0.05.||3.53|0.51|0.60
72350719|NCT03089541|144222068|SUPERIORITY||Odds Ratio (OR)|1.8||||0.06|TWO_SIDED|95.0|0.96|3.38|||Regression, Logistic|||Model on Public Space adjusted for timing of the assessment (weekend, time of day (am vs. pm), and day of study (1 to 7)). The significance level was 0.05.||3.38|0.96|0.06
72350720|NCT02119663|144222069|OTHER||Hazard Ratio (HR)|1.584|||||TWO_SIDED|95.0|0.886|2.83||||||||2.830|0.886|
72350721|NCT02863328|144222075|NON_INFERIORITY|This hypothesis was controlled for multiplicity. Results are based on the data from the in-trial observation period. The estimated treatment effect includes the effect of any rescue medication and any effect after premature trial product discontinuation (treatment policy estimand). A value of 0.4% (the non-inferiority margin) was added to imputed values at week 26 for the oral semaglutide treatment arm only.|Treatment difference|-0.4|||<|0.0001|TWO_SIDED|95.0|-0.6|-0.3||Unadjusted two-sided p-value for test of no difference from the non-inferiority margin (non-inferiority). The non-inferiority margin was 0.4%.|Pattern mixture model||Oral semaglutide 14 mg - Empagliflozin 25 mg|The analysis was based on a pattern mixture model using multiple imputation to handle missing week 26 data, assuming that data were missing at random within the groups used for imputation. The imputed data sets were analysed using an analysis of covariance (ANCOVA) model with treatment and region as categorical fixed effects and baseline HbA1c value as covariate for each of the 1000 imputed complete data sets, and pooled by Rubin's rule to draw inference.||-0.3|-0.6|< 0.0001
72350722|NCT02863328|144222075|SUPERIORITY|This hypothesis was controlled for multiplicity. Results are based on the data from the in-trial observation period. The estimated treatment effect includes the effect of any rescue medication and any effect after premature trial product discontinuation (treatment policy estimand).|Treatment difference|-0.4|||<|0.0001|TWO_SIDED|95.0|-0.6|-0.3||Unadjusted two-sided p-value for test of no difference from 0 (superiority).|Pattern mixture model||Oral semaglutide 14 mg - Empagliflozin 25 mg|The analysis was based on a pattern mixture model using multiple imputation to handle missing week 26 data, assuming that data were missing at random within the groups used for imputation. The imputed data sets were analysed using an ANCOVA model with treatment and region as categorical fixed effects and baseline HbA1c value as covariate for each of the 1000 imputed complete data sets, and pooled by Rubin's rule to draw inference.||-0.3|-0.6|< 0.0001
72350723|NCT02863328|144222075|NON_INFERIORITY|This hypothesis was not controlled for multiplicity. Results are based on the data from the on-treatment without rescue medication observation period. The estimated treatment effect excludes the effect of any rescue medication and any effect after premature trial product discontinuation (hypothetical estimand).|Treatment difference|-0.5|||<|0.0001|TWO_SIDED|95.0|-0.7|-0.4||Unadjusted two-sided p-value for test of no difference from the non-inferiority margin (non-inferiority). The non-inferiority margin was 0.4%.|MMRM||Oral semaglutide 14 mg - Empagliflozin 25 mg|The analysis was based on a mixed model for repeated measurements (MMRM) that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 26. The independent effects were treatment and region as categorical fixed effects and the baseline HbA1c value as a covariate, all nested within visit, and an unstructured residual covariance matrix.||-0.4|-0.7|<0.0001
72350724|NCT02863328|144222075|SUPERIORITY|This hypothesis was not controlled for multiplicity. Results are based on the data from the on-treatment without rescue medication observation period. The estimated treatment effect excludes the effect of any rescue medication and any effect after premature trial product discontinuation (hypothetical estimand).|Treatment difference|-0.5|||<|0.0001|TWO_SIDED|95.0|-0.7|-0.4||Unadjusted two-sided p-value for test of no difference from 0 (superiority).|MMRM||Oral semaglutide 14 mg - Empagliflozin 25 mg|The analysis was based on a MMRM that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 26. The independent effects were treatment and region as categorical fixed effects and the baseline HbA1c value as a covariate, all nested within visit, and an unstructured residual covariance matrix.||-0.4|-0.7|<0.0001
72350725|NCT02863328|144222076|SUPERIORITY|This hypothesis was controlled for multiplicity. Results are based on the data from the in-trial observation period. The estimated treatment effect includes the effect of any rescue medication and any effect after premature trial product discontinuation (treatment policy estimand).|Treatment difference|-0.1|||=|0.7593|TWO_SIDED|95.0|-0.7|0.5||Unadjusted two-sided p-value for test of no difference from 0 (superiority).|Pattern mixture model||Oral semaglutide 14 mg - Empagliflozin 25 mg|The analysis was based on a pattern mixture model using multiple imputation to handle missing week 26 data, assuming that data were missing at random within the groups used for imputation. The imputed data sets were analysed using an ANCOVA model with treatment and region as categorical fixed effects and baseline body weight value as covariate for each of the 1000 imputed complete data sets, and pooled by Rubin's rule to draw inference.||0.5|-0.7|= 0.7593
72350726|NCT02863328|144222076|SUPERIORITY|This hypothesis was not controlled for multiplicity. Results are based on the data from the on-treatment without rescue medication observation period. The estimated treatment effect excludes the effect of any rescue medication and any effect after premature trial product discontinuation (hypothetical estimand).|Treatment difference|-0.4|||=|0.1358|TWO_SIDED|95.0|-1.0|0.1||Unadjusted two-sided p-value for test of no difference from 0 (superiority).|MMRM||Oral semaglutide 14 mg - Empagliflozin 25 mg|The analysis was based on a MMRM that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 26. The independent effects were treatment and region as categorical fixed effects and the baseline body weight value as a covariate, all nested within visit, and an unstructured residual covariance matrix.||0.1|-1.0|= 0.1358
72350727|NCT02863328|144222104|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|0.85||||0.3552|TWO_SIDED|95.0|0.6|1.2||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox||Oral semaglutide 14 mg / Empagliflozin 25 mg|Time to initiation of additional anti-diabetic medication was analysed using a Cox proportional hazards model with treatment and region as categorical fixed effects and baseline HbA1c as covariate. Withdrawal for any reason or lost to follow-up contributed to the analysis as events (initiation of additional anti-diabetic medication). Censoring time was one day before planned end of treatment.||1.20|0.60|0.3552
72350728|NCT02863328|144222105|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|0.75||||0.225|TWO_SIDED|95.0|0.47|1.19||Unadjusted two-sided p-value for test of no difference from 1.|Cox proportional hazards model||Oral semaglutide 14 mg / Empagliflozin 25 mg|Time to initiation of rescue medication was analysed using a Cox proportional hazards model with treatment and region as categorical fixed effects and baseline HbA1c as covariate. Censoring time was one day before last day on trial product.||1.19|0.47|0.2250
72350729|NCT00699660|144222125|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Comparison of CAPS/WHODAS vs Nonstructured Interview study arms: linear and logistic mixed effects regression with clinical examiner stratified by study group as a random effect and study group as a fixed effect.|Regression, Linear|Covariates included experience, use of template,tests,reviewing records,age,education, study site,reviewer, and expert reviewer by group interaction.||Our sample size calculation yielded 466 for a power of 0.80 to detect a 10% absolute difference in sensitivity and adjusted for intraclass correlation. The number of covariates in regression models was limited to ensure the effective sample size remained ten times greater than the degrees of freedom in the model.||||<.001
72350730|NCT00699660|144222126|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||Regression, Logistic|||||||<.01
72350731|NCT00699660|144222127|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||Descriptive statistics on mean and standard deviation.|t-test, 2 sided|||||||>.05
72350732|NCT00699660|144222128|SUPERIORITY_OR_OTHER||Slope|47.3|STANDARD_ERROR_OF_MEAN|18.86||0.012|TWO_SIDED|||||0.05 level based on a two tailed test.|Regression, Linear|Covariates included years of experience, use of template, use of tests, age, education, study site.||Estimates of the influence on total time and tests of statistical significance were derived from multilevel mixed-effects linear regression (xtmixed in Stata)||||.012
72350733|NCT00064792|144222134|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||t-test, 2 sided|||The primary outcome variable will be the serum cholesterol/total sterol ratio.||||0.002
72350734|NCT00064792|144222135|SUPERIORITY_OR_OTHER|||||||0.22|||||||t-test, 2 sided|||||||0.22
72350735|NCT00286429|144222168|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.51|||<|0.001|TWO_SIDED|95.0|-0.72|-0.3||A step-down strategy was used for the primary analysis. First, the 25mg dose was compared to placebo at the 2-sided 0.05 significance level. The 12.5 mg dose was compared to placebo only if the comparison of the 25mg dose to placebo was significant.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and HbA1c).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HbA1c at Week 26. For comparison of either alogliptin dose vs. placebo (2-sample t test), study sample size \>=390 participants had 95% power to detect a treatment difference as small as 0.4% in the per protocol analysis set assuming a standard deviation of 0.8%, a 2-sided test at 0.05 significance level and \>=80% of subjects meeting the per protocol criteria.||-0.30|-0.72|<0.001
72350736|NCT00286429|144222168|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.59|||<|0.001|TWO_SIDED|95.0|-0.8|-0.37||A step-down strategy was used for the primary analysis. First, the 25mg dose was compared to placebo at the 2-sided 0.05 significance level. The 12.5 mg dose was compared to placebo only if the comparison of the 25mg dose to placebo was significant.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and HbA1c).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HbA1c at Week 26. For comparison of either alogliptin dose vs. placebo (2-sample t test), study sample size \>=390 participants had 95% power to detect a treatment difference as small as 0.4% in the per protocol analysis set assuming a standard deviation of 0.8%, a 2-sided test at 0.05 significance level and \>=80% of subjects meeting the per protocol criteria.||-0.37|-0.80|<0.001
72350737|NCT00286429|144222169|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.21|||<|0.001|TWO_SIDED|95.0|-0.34|-0.09||No multiplicity adjustments|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and HbA1c).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HbA1c at Week 4. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.||-0.09|-0.34|<0.001
72350738|NCT00286429|144222169|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.32|||<|0.001|TWO_SIDED|95.0|-0.45|-0.2||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and HbA1c).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HbA1c at Week 4. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.||-0.20|-0.45|<0.001
72369487|NCT00048074|144249148|NON_INFERIORITY_OR_EQUIVALENCE|The IV dosing regimen (3mg q 3 mo IV) was considered non-inferior to the 2.5 mg daily regimen if the lower bound of the two-sided 95% CI on the difference in mean percent change in BMD was greater or equal to -1 percentage point.|Mean Difference (Final Values)|1.025|||<|0.001|TWO_SIDED|95.0|0.471|1.578|||ANOVA||Treatment effect is the difference in the mean values of the IV regimen (3mg q 3 mo IV) and the active-control.|The primary hypothesis was that the difference in the effects of daily oral ibandronate and IV ibandronate (3mg q 3 mo IV) on the relative change in lumbar spine BMD (L2 - L4) was small, no more than 1%, the margin of clinical equivalence.||1.578|0.471|<0.001
72350739|NCT00286429|144222170|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.48|||<|0.001|TWO_SIDED|95.0|-0.65|-0.31||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and HbA1c).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HbA1c at Week 8. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.||-0.31|-0.65|<0.001
72350740|NCT00286429|144222170|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.56|||<|0.001|TWO_SIDED|95.0|-0.73|-0.39||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and HbA1c).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HbA1c at Week 8. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.||-0.39|-0.73|<0.001
72350741|NCT00286429|144222171|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.57|||<|0.001|TWO_SIDED|95.0|-0.77|-0.37||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and HbA1c).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HbA1c at Week 12. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.||-0.37|-0.77|<0.001
72350742|NCT00286429|144222171|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.54|||<|0.001|TWO_SIDED|95.0|-0.75|-0.34||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and HbA1c).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HbA1c at Week 12. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.||-0.34|-0.75|<0.001
72350743|NCT00286429|144222172|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.58|||<|0.001|TWO_SIDED|95.0|-0.79|-0.37||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and HbA1c).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HbA1c at Week 16. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.||-0.37|-0.79|<0.001
72350744|NCT00286429|144222172|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.54|||<|0.001|TWO_SIDED|95.0|-0.75|-0.33||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and HbA1c).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HbA1c at Week 16. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.||-0.33|-0.75|<0.001
72350745|NCT00286429|144222173|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.59|||<|0.001|TWO_SIDED|95.0|-0.8|-0.37||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and HbA1c).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HbA1c at Week 20. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.||-0.37|-0.80|<0.001
72350746|NCT00286429|144222173|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.57|||<|0.001|TWO_SIDED|95.0|-0.79|-0.35||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and HbA1c).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HbA1c at Week 20. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.||-0.35|-0.79|<0.001
72350747|NCT00286429|144222174|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.3||||0.128|TWO_SIDED|95.0|-25.9|3.3||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and FPG).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in FPG at Week 1. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.||3.3|-25.9|0.128
72369488|NCT01032889|144249190|SUPERIORITY_OR_OTHER||Difference from placebo|-0.3||||0.052|TWO_SIDED|95.0|-0.61|0.0|||ANCOVA|The ANCOVA model included terms for treatment group and the baseline covariate.||There was no formal hypothesis testing and no adjustments for multiple comparisons.||0.00|-0.61|0.052
72369489|NCT01032889|144249190|SUPERIORITY_OR_OTHER||Difference from placebo|-0.5||||0.003|TWO_SIDED|95.0|-0.77|-0.16|||ANCOVA|The ANCOVA model included terms for treatment group and the baseline covariate.||There was no formal hypothesis testing and no adjustments for multiple comparisons.||-0.16|-0.77|0.003
72350748|NCT00286429|144222174|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.1||||0.034|TWO_SIDED|95.0|-31.1|-1.2||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and FPG).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in FPG at Week 1. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.||-1.2|-31.1|0.034
72350749|NCT00286429|144222175|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.1||||0.563|TWO_SIDED|95.0|-17.9|9.7||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and FPG).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in FPG at Week 2. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.||9.7|-17.9|0.563
72350750|NCT00286429|144222175|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.4||||0.084|TWO_SIDED|95.0|-26.4|1.7||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and FPG).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in FPG at Week 2. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.||1.7|-26.4|0.084
72350751|NCT00286429|144222176|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.3||||0.16|TWO_SIDED|95.0|-24.7|4.1||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and FPG).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in FPG at Week 4. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.||4.1|-24.7|0.160
72350752|NCT00286429|144222176|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.4||||0.02|TWO_SIDED|95.0|-32.1|-2.8||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and FPG).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in FPG at Week 4. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.||-2.8|-32.1|0.020
72350753|NCT00286429|144222177|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-18.9||||0.013|TWO_SIDED|95.0|-33.7|-4.0||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and FPG).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in FPG at Week 8. The treatment effect was be evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.||-4.0|-33.7|0.013
72350754|NCT00286429|144222177|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.5||||0.011|TWO_SIDED|95.0|-34.5|-4.5||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and FPG).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in FPG at Week 8. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.||-4.5|-34.5|0.011
72350755|NCT00286429|144222178|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.8||||0.624|TWO_SIDED|95.0|-18.9|11.3||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and FPG).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in FPG at Week 12. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.||11.3|-18.9|0.624
72350756|NCT00286429|144222178|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.4||||0.853|TWO_SIDED|95.0|-16.7|13.8||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and FPG).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in FPG at Week 12. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.||13.8|-16.7|0.853
72369490|NCT01032889|144249191|SUPERIORITY_OR_OTHER||Difference from placebo|-0.2||||0.117|TWO_SIDED|95.0|-0.55|0.06|||ANCOVA|The ANCOVA model included terms for treatment group and the baseline covariate.||There was no formal hypothesis testing and no adjustments for multiple comparisons.||0.06|-0.55|0.117
72369491|NCT01032889|144249191|SUPERIORITY_OR_OTHER||Difference from placebo|-0.6|||<|0.001|TWO_SIDED|95.0|-0.91|-0.3|||ANCOVA|The ANCOVA model included terms for treatment group and the baseline covariate.||There was no formal hypothesis testing and no adjustments for multiple comparisons.||-0.30|-0.91|<0.001
72350757|NCT00286429|144222179|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.9||||0.19|TWO_SIDED|95.0|-24.7|4.9||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and FPG).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in FPG at Week 16. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.||4.9|-24.7|0.190
72350758|NCT00286429|144222179|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.9||||0.154|TWO_SIDED|95.0|-25.8|4.1||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and FPG).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in FPG at Week 16. The treatment effect was be evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.||4.1|-25.8|0.154
72350759|NCT00286429|144222180|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.7||||0.097|TWO_SIDED|95.0|-27.8|2.3||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and FPG).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in FPG at Week 20. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.||2.3|-27.8|0.097
72350760|NCT00286429|144222180|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.9||||0.01|TWO_SIDED|95.0|-35.1|-4.7||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and FPG).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in FPG at Week 20. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.||-4.7|-35.1|0.010
72350761|NCT00286429|144222181|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.5||||0.662|TWO_SIDED|95.0|-19.2|12.2||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and FPG).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in FPG at Week 26. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.||12.2|-19.2|0.662
72350762|NCT00286429|144222181|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.6||||0.03|TWO_SIDED|95.0|-33.4|-1.7||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and FPG).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in FPG at Week 26. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.||-1.7|-33.4|0.030
72350763|NCT00286429|144222182|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.551||||0.075|TWO_SIDED|95.0|0.286|1.063||No multiplicity adjustments.|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline metformin regimen, baseline insulin dose, and baseline HbA1c.|Odds Ratio (OR) is alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|The null hypothesis that there is no treatment effect between alogliptin and placebo arms in number of participants with marked hyperglycemia. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a Wald test at the 0.05 significance level.||1.063|0.286|0.075
72350764|NCT00286429|144222182|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.364||||0.002|TWO_SIDED|95.0|0.191|0.695||No multiplicity adjustments.|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline metformin regimen, baseline insulin dose, and baseline HbA1c.|Odds Ratio (OR) is alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|The null hypothesis that there is no treatment effect between alogliptin and placebo arms in number of participants with marked hyperglycemia. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a Wald test at the 0.05 significance level.||0.695|0.191|0.002
72350765|NCT00286429|144222183|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.35|||<|0.001|TWO_SIDED|95.0|0.198|0.619||No multiplicity adjustments.|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline metformin regimen, baseline insulin dose, and baseline HbA1c.|Odds Ratio (OR) is alogliptin arm versus placebo arm. OR \<1.0 indicates lower incidence compared to placebo.|The null hypothesis that there is no treatment effect between alogliptin and placebo arms in number of participants requiring rescue. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a Wald test at the 0.05 significance level.||0.619|0.198|<0.001
72350766|NCT00286429|144222183|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.339|||<|0.001|TWO_SIDED|95.0|0.189|0.608||No multiplicity adjustments.|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline metformin regimen, baseline insulin dose, and baseline HbA1c.|Odds Ratio (OR) is alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|The null hypothesis that there is no treatment effect between alogliptin and placebo arms in number of participants requiring rescue. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a Wald test at the 0.05 significance level.||0.608|0.189|<0.001
72350767|NCT00286429|144222184|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.156||||0.286|TWO_SIDED|95.0|-0.131|0.443||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and C-peptide).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in C-Peptide at Week 4. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.||0.443|-0.131|0.286
72350768|NCT00286429|144222184|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.477||||0.001|TWO_SIDED|95.0|0.188|0.765||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and C-peptide).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in C-peptide at Week 4. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.||0.765|0.188|0.001
72350769|NCT00286429|144222185|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.202||||0.236|TWO_SIDED|95.0|-0.132|0.536||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and C-peptide).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in C-Peptide at Week 8. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.||0.536|-0.132|0.236
72350770|NCT00286429|144222185|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.372||||0.032|TWO_SIDED|95.0|0.032|0.712||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and C-peptide).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in C-Peptide at Week 8. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.||0.712|0.032|0.032
72350771|NCT00286429|144222186|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.126||||0.562|TWO_SIDED|95.0|-0.302|0.554||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and C-peptide).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in C-peptide at Week 12. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.||0.554|-0.302|0.562
72350772|NCT00286429|144222186|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.183||||0.407|TWO_SIDED|95.0|-0.251|0.616||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and C-peptide).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in C-peptide at Week 12. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.||0.616|-0.251|0.407
72350773|NCT00286429|144222187|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.078||||0.716|TWO_SIDED|95.0|-0.344|0.5||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and C-peptide).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in C-peptide at Week 16. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.||0.500|-0.344|0.716
72350774|NCT00286429|144222187|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.156||||0.474|TWO_SIDED|95.0|-0.272|0.583||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and C-peptide).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in C-peptide at Week 16. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.||0.583|-0.272|0.474
72350775|NCT00286429|144222188|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.079||||0.7|TWO_SIDED|95.0|-0.324|0.482||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and C-peptide).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in C-peptide at Week 20. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.||0.482|-0.324|0.700
72350776|NCT00286429|144222188|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.042||||0.839|TWO_SIDED|95.0|-0.366|0.45||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and C-peptide).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in C-peptide at Week 20. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.||0.450|-0.366|0.839
72350777|NCT00286429|144222189|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.282||||0.091|TWO_SIDED|95.0|-0.045|0.61||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and C-peptide).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in C-peptide at Week 26. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.||0.610|-0.045|0.091
72350778|NCT00286429|144222189|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.125||||0.459|TWO_SIDED|95.0|-0.207|0.457||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and C-peptide).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in C-peptide at Week 26. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.||0.457|-0.207|0.459
72350779|NCT00286429|144222191|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|12.65||||0.016|TWO_SIDED|95.0|1.589|100.682||No multiplicity adjustments.|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline metformin regimen, baseline insulin dose, and baseline HbA1c.|Odds Ratio (OR) compares alogliptin arm versus placebo. OR \>1.0 indicates higher incidence of response compared to placebo.|The null hypothesis that there is no treatment effect between alogliptin and placebo arms in incidence of HbA1c ≤7.0%. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a Wald test at the 0.05 significance level.||100.682|1.589|0.016
72350780|NCT00286429|144222191|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|11.255||||0.023|TWO_SIDED|95.0|1.401|90.379||No multiplicity adjustments.|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline metformin regimen, baseline insulin dose, and baseline HbA1c.|Odds Ratio (OR) compares alogliptin arm versus placebo. OR \>1.0 indicates higher incidence of response compared to placebo.|The null hypothesis that there is no treatment effect between alogliptin and placebo arms in incidence of HbA1c ≤7.0%. The treatment effect was evaluated as a contrast of each active dose versus placebo was evaluated inferentially with a Wald test at the 0.05 significance level||90.379|1.401|0.023
72350781|NCT00286429|144222192|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.777|||<|0.001|TWO_SIDED|95.0|2.047|16.305||No multiplicity adjustments.|ANCOVA|Logistic regression model includes effects for treatment, geographic region, baseline metformin regimen, baseline insulin dose, and baseline HbA1c|Odds Ratio (OR) compares alogliptin arm versus placebo. OR \>1.0 indicates higher incidence of response compared to placebo.|The null hypothesis that there is no treatment effect between alogliptin and placebo arms in incidence of HbA1c ≤7.5%. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a Wald test at the 0.05 significance level.||16.305|2.047|<0.001
72350782|NCT00286429|144222192|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|9.784|||<|0.001|TWO_SIDED|95.0|3.54|27.039||No multiplicity adjustments.|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline metformin regimen, baseline insulin dose, and baseline HbA1c|Odds Ratio (OR) compares alogliptin arm versus placebo. OR \>1.0 indicates higher incidence of response compared to placebo.|The null hypothesis that there is no treatment effect between alogliptin and placebo arms in incidence of HbA1c ≤7.5%. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a Wald test at the 0.05 significance level.||27.039|3.540|<0.001
72350783|NCT00286429|144222193|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.674|||<|0.001|TWO_SIDED|95.0|1.579|4.53||No multiplicity adjustments.|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline metformin regimen, baseline insulin dose, and baseline HbA1c.|Odds Ratio (OR) compares alogliptin arm versus placebo. OR \>1.0 indicates higher incidence of response compared to placebo.|The null hypothesis that there is no treatment effect between alogliptin and placebo arms in incidence of HbA1c decrease from baseline ≥0.5%. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a Wald test at the 0.05 significance level.||4.530|1.579|<0.001
72350784|NCT00286429|144222193|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.819|||<|0.001|TWO_SIDED|95.0|1.653|4.808||No multiplicity adjustments.|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline metformin regimen, baseline insulin dose, and baseline HbA1c.|Odds Ratio (OR) compares alogliptin arm versus placebo. OR \>1.0 indicates higher incidence of response compared to placebo.|The null hypothesis that there is no treatment effect between alogliptin and placebo arms in incidence of HbA1c decrease from baseline ≥0.5%. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a Wald test at the 0.05 significance level.||4.808|1.653|<0.001
72369492|NCT01032889|144249192|SUPERIORITY_OR_OTHER||Difference from placebo|-1.4||||0.005|TWO_SIDED|95.0|-2.44|-0.46|||ANCOVA|The ANCOVA model included terms for treatment group and the baseline covariate.||There was no formal hypothesis testing and no adjustments for multiple comparisons.||-0.46|-2.44|0.005
72369493|NCT01032889|144249192|SUPERIORITY_OR_OTHER||Difference from placebo|-2.5|||<|0.001|TWO_SIDED|95.0|-3.48|-1.48|||ANCOVA|The ANCOVA model included terms for treatment group and the baseline covariate.||There was no formal hypothesis testing and no adjustments for multiple comparisons.||-1.48|-3.48|<0.001
72350785|NCT00286429|144222194|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.163|||<|0.001|TWO_SIDED|95.0|1.651|6.06||No multiplicity adjustments.|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline metformin regimen, baseline insulin dose, and baseline HbA1c.|Odds Ratio (OR) compares alogliptin arm versus placebo. OR \>1.0 indicates higher incidence of response compared to placebo.|The null hypothesis that there is no treatment effect between alogliptin and placebo arms in incidence of HbA1c decrease from baseline ≥1.0%. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a Wald test at the 0.05 significance level.||6.060|1.651|<0.001
72350786|NCT00286429|144222194|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.989|||<|0.001|TWO_SIDED|95.0|2.083|7.64||No multiplicity adjustments.|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline metformin regimen, baseline insulin dose, and baseline HbA1c.|Odds Ratio (OR) compares alogliptin arm versus placebo. OR \>1.0 indicates higher incidence of response compared to placebo.|The null hypothesis that there is no treatment effect between alogliptin and placebo arms in incidence of HbA1c decrease from baseline ≥1.0%. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a Wald test at the 0.05 significance level.||7.640|2.083|<0.001
72350787|NCT00286429|144222195|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.55||||0.002|TWO_SIDED|95.0|1.732|11.953||No multiplicity adjustments.|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline metformin regimen, baseline insulin dose, and baseline HbA1c.|Odds Ratio (OR) compares alogliptin arm versus placebo. OR \>1.0 indicates higher incidence of response compared to placebo.|The null hypothesis that there is no treatment effect between alogliptin and placebo arms in incidence of HbA1c decrease from baseline ≥1.5%. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a Wald test at the 0.05 significance level.||11.953|1.732|0.002
72350788|NCT00286429|144222195|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.58||||0.002|TWO_SIDED|95.0|1.74|12.052||No multiplicity adjustments.|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline metformin regimen, baseline insulin dose, and baseline HbA1c.|Odds Ratio (OR) compares alogliptin arm versus placebo. OR \>1.0 indicates higher incidence of response compared to placebo.|The null hypothesis that there is no treatment effect between alogliptin and placebo arms in incidence of HbA1c decrease from baseline ≥1.5%. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a Wald test at the 0.05 significance level.||12.052|1.740|0.002
72350789|NCT00286429|144222197|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.28||||0.291|TWO_SIDED|95.0|-0.81|0.24||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and weight).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in body weight at Week 8. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.||0.24|-0.81|0.291
72350790|NCT00286429|144222197|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.21||||0.439|TWO_SIDED|95.0|-0.74|0.32||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and weight).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in body weight at Week 8. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.||0.32|-0.74|0.439
72350791|NCT00286429|144222198|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.06||||0.841|TWO_SIDED|95.0|-0.67|0.55||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and weight).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in body weight at Week 12. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.||0.55|-0.67|0.841
72350792|NCT00286429|144222198|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.18||||0.556|TWO_SIDED|95.0|-0.8|0.43||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and weight).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in body weight at Week 12. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.||0.43|-0.80|0.556
72350793|NCT00286429|144222199|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.18||||0.586|TWO_SIDED|95.0|-0.81|0.46||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and weight).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in body weight at Week 20. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.||0.46|-0.81|0.586
72369494|NCT01032889|144249193|SUPERIORITY_OR_OTHER||Difference from placebo|-606.0||||0.166|TWO_SIDED|95.0|-1482.0|269.3|||ANCOVA|The ANCOVA model included terms for treatment group and the baseline covariate.||||269.3|-1482|0.166
72369495|NCT01032889|144249193|SUPERIORITY_OR_OTHER||Difference from placebo|-110.0||||0.803|TWO_SIDED|95.0|-1013.0|792.6|||ANCOVA|The ANCOVA model included terms for treatment group and the baseline covariate.||||792.6|-1013|0.803
72369496|NCT01032889|144249194|SUPERIORITY_OR_OTHER||Difference from placebo|-1.5|||<|0.001|TWO_SIDED|95.0|-2.32|-0.69|||ANCOVA|The ANCOVA model included terms for treatment group and the baseline covariate.||||-0.69|-2.32|<0.001
72350794|NCT00286429|144222199|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.27||||0.404|TWO_SIDED|95.0|-0.91|0.37||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and weight).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in body weight at Week 20. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.||0.37|-0.91|0.404
72350795|NCT00286429|144222200|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.05||||0.874|TWO_SIDED|95.0|-0.62|0.72||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and weight).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in body weight at Week 26. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.||0.72|-0.62|0.874
72350796|NCT00286429|144222200|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02||||0.948|TWO_SIDED|95.0|-0.7|0.65||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and weight).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in body weight at Week 26. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.||0.65|-0.70|0.948
72350797|NCT01973413|144222201|NON_INFERIORITY_OR_EQUIVALENCE|Significance level of 0.05, 90% power, required 48 nights of OCL and 48 control nights to detect a 20% improvement.|||||=|0.037|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||=0.037
72350798|NCT01973413|144222202|SUPERIORITY_OR_OTHER||||||=|0.34|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||=0.340
72350799|NCT03160898|144222212|SUPERIORITY||least squares mean treatment difference|1.61|STANDARD_ERROR_OF_MEAN|1.003||0.1095|TWO_SIDED|95.0|-0.36|3.58|||Mixed Models Analysis|Analyzed by an MMRM with contrast (-5, -1, 3, 3) to reflect the assumed relationship for the 4 groups: placebo, 150, 300, and 450 mg twice daily.||"The statistical null hypothesis was as follows: there was no assumed dose-response relationship in percent predicted SVC change from baseline to Week 12 among all three active doses and placebo, expressed as:~H0: -5 x µ placebo - 1 x µ 150 mg twice daily + 3 x µ 300 mg twice daily + 3 x µ 450 mg twice daily = 0 where µ was the mean of the efficacy endpoint for the designated group."||3.58|-0.36|0.1095
72350800|NCT03160898|144222212|SUPERIORITY||Least squares mean difference|1.49|STANDARD_ERROR_OF_MEAN|1.291||0.2501|TWO_SIDED|95.0|-1.05|4.03|||Mixed Models Analysis|||||4.03|-1.05|0.2501
72350801|NCT03160898|144222212|SUPERIORITY||Least squares mean difference|1.84|STANDARD_ERROR_OF_MEAN|1.29||0.1549|TWO_SIDED|95.0|-0.7|4.38|||Mixed Models Analysis|||||4.38|-0.7|0.1549
72350802|NCT03160898|144222212|SUPERIORITY||Least squares mean difference|1.88|STANDARD_ERROR_OF_MEAN|1.274||0.1417|TWO_SIDED|95.0|-0.63|4.38|||Mixed Models Analysis|||||4.38|-0.63|0.1417
72350803|NCT03160898|144222212|SUPERIORITY||Least squares mean difference|1.86|STANDARD_ERROR_OF_MEAN|1.115||0.0964|TWO_SIDED|95.0|-0.33|4.05|||Mixed Models Analysis|||||4.05|-0.33|0.0964
72350804|NCT03160898|144222213|SUPERIORITY||Least squares mean difference|0.56|STANDARD_ERROR_OF_MEAN|0.335||0.093|TWO_SIDED|95.0|-0.09|1.22|||Mixed Models Analysis|Analyzed by an MMRM with contrast (-5, -1, 3, 3) to reflect the assumed relationship for the 4 groups: placebo, 150, 300, and 450 mg twice daily.||||1.22|-0.09|0.0930
72350805|NCT03160898|144222213|SUPERIORITY||Least squares mean difference|1.13|STANDARD_ERROR_OF_MEAN|0.427||0.0087|TWO_SIDED|95.0|0.29|1.97|||Mixed Models Analysis|||||1.97|0.29|0.0087
72350806|NCT03160898|144222213|SUPERIORITY||Least squares mean difference|0.91|STANDARD_ERROR_OF_MEAN|0.43||0.0351|TWO_SIDED|95.0|0.06|1.75|||Mixed Models Analysis|||||1.75|0.06|0.0351
72350807|NCT03160898|144222213|SUPERIORITY||Least squares mean difference|0.59|STANDARD_ERROR_OF_MEAN|0.425||0.1642|TWO_SIDED|95.0|-0.24|1.43|||Mixed Models Analysis|||||1.43|-0.24|0.1642
72350808|NCT03160898|144222213|SUPERIORITY||Least squares mean difference|0.75|STANDARD_ERROR_OF_MEAN|0.371||0.0435|TWO_SIDED|95.0|0.02|1.48|||Mixed Models Analysis|||||1.48|0.02|0.0435
72350809|NCT03160898|144222214|SUPERIORITY||Slope difference|0.0276|STANDARD_ERROR_OF_MEAN|0.02734||0.3134|TWO_SIDED|95.0|-0.0261|0.0813|||Mixed Models Analysis|Analyzed by an MMRM with contrast (-5, -1, 3, 3) to reflect the assumed relationship for the 4 groups: placebo, 150, 300, and 450 mg twice daily.||||0.0813|-0.0261|0.3134
72350810|NCT03160898|144222214|SUPERIORITY||Least squares mean difference|0.0246||||0.4824|TWO_SIDED|95.0|-0.0442|0.0935|||Mixed Models Analysis|||||0.0935|-0.0442|0.4824
72350811|NCT03160898|144222214|SUPERIORITY||Least squares mean difference|0.0146||||0.6787|TWO_SIDED|95.0|-0.0544|0.0835|||Mixed Models Analysis|||||0.0835|-0.0544|0.6787
72350812|NCT03160898|144222214|SUPERIORITY||Least squares mean difference|0.0488||||0.1604|TWO_SIDED|95.0|-0.0194|0.1171|||Mixed Models Analysis|||||0.1171|-0.0194|0.1604
72350813|NCT03160898|144222214|SUPERIORITY||Least squares mean difference|0.0317||||0.2966|TWO_SIDED|95.0|-0.0279|0.0913|||Mixed Models Analysis|||||0.0913|-0.0279|0.2966
72350814|NCT03421106|144222245|SUPERIORITY||Mean Difference (Net)|2.53||||0.23|TWO_SIDED||||||Mixed Models Analysis|||||||0.23
72350815|NCT02663622|144222256|SUPERIORITY||Cox Proportional Hazard|0.13||||0.0274|TWO_SIDED|95.0|0.01|0.62|||Log Rank|Log-rank test stratified by the matched sets||A hazard ratio was calculated based on a Cox proportional hazards regression model with treatment as a factor using the robust sandwich covariance estimator, comparing the CD24Fc 960 mg arm to a matched control group consisting of 92 participants from the Center for International Blood and Marrow Transplant Research (CIBMTR) observational databases of clinical information on HCT, whose mean grade III-IV AGFS in days was 135.8 with an SD of 64.66.||0.62|0.01|0.0274
72369497|NCT01032889|144249194|SUPERIORITY_OR_OTHER||Difference from placebo|-1.7|||<|0.001|TWO_SIDED|95.0|-2.46|-0.85|||ANCOVA|The ANCOVA model included terms for treatment group and the baseline covariate.||||-0.85|-2.46|<0.001
72350816|NCT02663622|144222257|SUPERIORITY||Cox Proportional Hazard|0.57||||0.0988|TWO_SIDED|95.0|0.3|1.08|||Log Rank|||A hazard ratio was calculated based on a Cox proportional hazards regression model with treatment as a factor using the robust sandwich covariance estimator, comparing the CD24Fc 960 mg arm to a matched control group consisting of 92 participants from the Center for International Blood and Marrow Transplant Research (CIBMTR) observational databases of clinical information on HCT, whose mean grade II-IV AGFS in days was 104.7 with an SD of 72.28.||1.08|0.30|0.0988
72350817|NCT02663622|144222263|SUPERIORITY||Cox Proportional Hazard|1.12||||0.9088|TWO_SIDED|95.0|0.43|2.88|||Log Rank|||A hazard ratio was calculated based on a Cox proportional hazards regression model with treatment as a factor using the robust sandwich covariance estimator, comparing the CD24Fc 960 mg arm to a matched control group consisting of 92 participants from the Center for International Blood and Marrow Transplant Research (CIBMTR) observational databases of clinical information on HCT, whose mean OS in days was 319.3 with an SD of 93.83.||2.88|0.43|0.9088
72350818|NCT02663622|144222265|SUPERIORITY||Cox Proportional Hazard|1.27||||0.6131|TWO_SIDED|95.0|0.66|2.46|||Log Rank|||A hazard ratio was calculated based on a Cox proportional hazards regression model with treatment as a factor using the robust sandwich covariance estimator, comparing the CD24Fc 960 mg arm to a matched control group consisting of 92 participants from the Center for International Blood and Marrow Transplant Research (CIBMTR) observational databases of clinical information on HCT, whose mean RFS in days was 296.0 with an SD of 115.32.||2.46|0.66|0.6131
72350819|NCT02936635|144222276|SUPERIORITY||Mean Difference (Final Values)|-3.9|STANDARD_ERROR_OF_MEAN|3.619||0.2821|TWO_SIDED|95.0|-11.035|3.23|||Mixed Models Analysis|||||3.23|-11.035|0.2821
72350820|NCT02936635|144222277|SUPERIORITY||Median Difference (Final Values)|-5.32|STANDARD_ERROR_OF_MEAN|4.242||0.2118|TWO_SIDED|95.0|-13.711|3.067|||Mixed Models Analysis|||||3.067|-13.711|0.2118
72350821|NCT02936635|144222278|SUPERIORITY||Mean Difference (Final Values)|-0.57|STANDARD_ERROR_OF_MEAN|1.205||0.6354|TWO_SIDED|95.0|-2.946|1.801|||Mixed Models Analysis|||||1.801|-2.946|0.6354
72350822|NCT02936635|144222279|SUPERIORITY||Mean Difference (Final Values)|-0.21|STANDARD_ERROR_OF_MEAN|1.509||0.8887|TWO_SIDED|95.0|-3.186|2.763|||Mixed Models Analysis|||||2.763|-3.186|0.8887
72350823|NCT00853151|144222351|SUPERIORITY_OR_OTHER|||||||0.623||90.0||||p-value is for LY2428757 plus TT223 3 mg versus LY2428757 plus TT223 placebo.|Mixed Models Analysis|Model included treatment, baseline therapy, strata, visit, and treatment-by-visit interaction, and continuous fixed covariate of baseline HbA1c.||||||0.623
72350824|NCT00853151|144222351|SUPERIORITY_OR_OTHER|||||||0.809||95.0||||p-value is for LY2428757 plus TT223 2 mg versus LY2428757 plus TT223 placebo.|Mixed Models Analysis|Model included treatment, baseline therapy, strata, visit, and treatment-by-visit interaction, and continuous fixed covariate of baseline HbA1c.||||||0.809
72350825|NCT00797277|144222405|NON_INFERIORITY_OR_EQUIVALENCE|There was no previous study comparing these 2 treatments. We hypothesized that the mean difference between the 2 treatments would be small.|Mean Difference (Final Values)|1.0|||<|0.05|||||||t-test, 2 sided|||we hypothesized that there would be no statistical significant difference between the 2 groups in the primary outcome.||||<0.05
72350826|NCT01751984|144222407|SUPERIORITY||Least squares mean difference|-28.7|||<|0.0001|TWO_SIDED|95.0|-35.4|-22.1|||ANCOVA||The least squares mean difference was calculated as the value for the ETC-1002 60 mg arm minus the value for the placebo arm.|||-22.1|-35.4|<0.0001
72350827|NCT01751984|144222408|SUPERIORITY||Least squares mean difference|-18.0|||<|0.0001|TWO_SIDED|95.0|-24.3|-11.8|||ANCOVA||Estimation from Week 2. The least squares mean difference was calculated as the value for the ETC-1002 60 mg arm minus the value for the placebo arm.|||-11.8|-24.3|<0.0001
72350828|NCT01751984|144222408|SUPERIORITY||Least squares mean difference|-30.0|||<|0.0001|TWO_SIDED|95.0|-35.2|-24.7|||ANCOVA||Estimation from Week 4. The least squares mean difference was calculated as the value for the ETC-1002 60 mg arm minus the value for the placebo arm.|||-24.7|-35.2|<0.0001
72350829|NCT01751984|144222408|SUPERIORITY||Least squares mean difference|-28.8|||<|0.0001|TWO_SIDED|95.0|-36.9|-20.8|||ANCOVA||Estimation from Week 6. The least squares mean difference was calculated as the value for the ETC-1002 60 mg arm minus the value for the placebo arm.|||-20.8|-36.9|<0.0001
72350830|NCT01751984|144222408|SUPERIORITY||Least squares mean difference|-28.5|||<|0.0001|TWO_SIDED|95.0|-37.2|-19.8|||ANCOVA||Estimation from Week 8. The least squares mean difference was calculated as the value for the ETC-1002 60 mg arm minus the value for the placebo arm.|||-19.8|-37.2|<0.0001
72350831|NCT01751984|144222409|SUPERIORITY||Least squares mean difference|-5.8||||0.1892|TWO_SIDED|95.0|-14.5|2.9|||ANCOVA||The least squares mean difference was calculated as the value for the ETC-1002 60 mg arm minus the value for the placebo arm.|||2.9|-14.5|0.1892
72350832|NCT01751984|144222410|SUPERIORITY||Least squares mean difference|-20.9|||<|0.0001|TWO_SIDED|95.0|-28.0|-13.9|||ANCOVA||The least squares mean difference was calculated as the value for the ETC-1002 60 mg arm minus the value for the placebo arm.|||-13.9|-28.0|<0.0001
72350833|NCT01751984|144222411|SUPERIORITY||Least squares mean difference|-18.4|||<|0.0001|TWO_SIDED|95.0|-24.2|-12.7|||ANCOVA||The least squares mean difference was calculated as the value for the ETC-1002 60 mg arm minus the value for the placebo arm.|||-12.7|-24.2|<0.0001
72350834|NCT01751984|144222412|SUPERIORITY||Least squares mean difference|18.7|||=|0.0962|TWO_SIDED|95.0|-3.5|40.8|||ANCOVA||The least squares mean difference was calculated as the value for the ETC-1002 60 mg arm minus the value for the placebo arm.|||40.8|-3.5|=0.0962
72350835|NCT01751984|144222413|SUPERIORITY||Least squares mean difference|-15.3|||=|0.0019|TWO_SIDED|95.0|-24.6|-6.0|||ANCOVA||The least squares mean difference was calculated as the value for the ETC-1002 60 mg arm minus the value for the placebo arm.|||-6.0|-24.6|=0.0019
72350836|NCT01751984|144222414|SUPERIORITY||Least squares mean difference|-4.2|||=|0.2555|TWO_SIDED|95.0|-11.7|3.2|||ANCOVA||The least squares mean difference was calculated as the value for the ETC-1002 60 mg arm minus the value for the placebo arm.|||3.2|-11.7|=0.2555
72350837|NCT01751984|144222415|SUPERIORITY||Least squares mean difference|11.7||||0.2563|TWO_SIDED|95.0|-8.8|32.1|||ANCOVA||The least squares mean difference was calculated as the value for the ETC-1002 60 mg arm minus the value for the placebo arm.|||32.1|-8.8|0.2563
72350838|NCT01751984|144222416|SUPERIORITY||Least squares mean difference|-23.7||||0.2565|TWO_SIDED|95.0|-65.4|18.0|||ANCOVA||The least squares mean difference was calculated as the value for the ETC-1002 60 mg arm minus the value for the placebo arm.|||18.0|-65.4|0.2565
72350839|NCT01751984|144222417|SUPERIORITY||Least squares mean difference|4.0||||0.776|TWO_SIDED|95.0|-24.1|32.0|||ANCOVA||The least squares mean difference was calculated as the value for the ETC-1002 60 mg arm minus the value for the placebo arm.|||32.0|-24.1|0.7760
72350840|NCT01751984|144222418|SUPERIORITY||Clopper-Pearson methodology|61.8|||<|0.0001|TWO_SIDED|95.0|45.4|78.1||Based on Fisher's exact test comparing the proportion of participants who achieved LDL-C goal at Week 8 (End of Study) in the ETC-1002 and placebo groups.|Fisher Exact||ETC-1002 minus placebo for the proportion of participants who achieved LDL-C goal at Week 8 (End of Study). The confidence interval was based on a normal approximation to the binomial distribution.|||78.1|45.4|<0.0001
72350841|NCT03187132|144222425|SUPERIORITY||Mean Difference (Final Values)|-1.86|STANDARD_ERROR_OF_MEAN|1.17||0.111|TWO_SIDED|95.0|-4.15|0.43|||Mixed Models Analysis||The estimate is for the Digital Pain Reduction Kit arm.|We used a repeated measures linear mixed model featuring fixed effects for time, study arm, and score at week 1, and random effects to account for within subject variation.||.43|-4.15|.111
72350842|NCT03187132|144222426|SUPERIORITY||Mean Difference (Final Values)|0.64|STANDARD_ERROR_OF_MEAN|1.27||0.612|TWO_SIDED|95.0|-1.84|3.12|||Mixed Models Analysis||The estimate is for the Digital Pain Reduction Kit arm.|We used a repeated measures linear mixed model featuring fixed effects for time, study arm, and score at week 1, and random effects to account for within subject variation.||3.12|-1.84|.612
72350843|NCT03187132|144222427|SUPERIORITY||Mean Difference (Final Values)|-0.42|STANDARD_ERROR_OF_MEAN|2.58||0.87|TWO_SIDED|95.0|-5.51|4.66|||t-test, 2 sided|||For work productivity measures, self-reported opioid utilization, and post-study measures of satisfaction, we used t-tests for normally distributed data and Wilcoxon Rank-Sum tests for non-normally distributed data.||4.66|-5.51|.87
72350844|NCT03187132|144222427|SUPERIORITY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.274||0.787|TWO_SIDED|95.0|-0.54|0.54|||t-test, 2 sided|||For work productivity measures, self-reported opioid utilization, and post-study measures of satisfaction, we used t-tests for normally distributed data and Wilcoxon Rank-Sum tests for non-normally distributed data.||.54|-.54|.787
72350845|NCT03187132|144222427|SUPERIORITY||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.34||0.569|TWO_SIDED|95.0|-0.88|0.48|||t-test, 2 sided|||For work productivity measures, self-reported opioid utilization, and post-study measures of satisfaction, we used t-tests for normally distributed data and Wilcoxon Rank-Sum tests for non-normally distributed data.||.48|-.88|.569
72350846|NCT03187132|144222428|SUPERIORITY||Mean Difference (Final Values)|0.13|STANDARD_ERROR_OF_MEAN|0.09||0.467|TWO_SIDED|95.0|-0.23|0.49|||t-test, 2 sided|||For work productivity measures, self-reported opioid utilization, and post-study measures of satisfaction, we used t-tests for normally distributed data and Wilcoxon Rank-Sum tests for non-normally distributed data.||.49|-.23|.467
72350847|NCT03187132|144222429|SUPERIORITY||Odds Ratio (OR)|0.79|STANDARD_ERROR_OF_MEAN|0.986||0.852|TWO_SIDED|95.0|0.07|9.07|||Regression, Logistic|||We used a multilevel logistic regression with random effects at the individual level and fixed effects for week and study-arm.||9.07|.07|.852
72350848|NCT03594773|144222463|SUPERIORITY||Mean Difference (Final Values)|-0.496|STANDARD_ERROR_OF_MEAN|1.56||0.752|TWO_SIDED|95.0|-3.62|2.63|||t-test, 2 sided|df=56, equal variances assumed||||2.63|-3.62|.752
72350849|NCT03594773|144222464|SUPERIORITY||Mean Difference (Final Values)|1.26|STANDARD_ERROR_OF_MEAN|2.62||0.633|TWO_SIDED|95.0|-4.01|6.52|||t-test, 2 sided|df=49, equal variances assumed||||6.52|-4.01|.633
72350850|NCT03594773|144222465|SUPERIORITY||Mean Difference (Final Values)|0.95|STANDARD_ERROR_OF_MEAN|1.73||0.586|TWO_SIDED|95.0|-2.53|4.44|||t-test, 2 sided|df=49, equal variances assumed||||4.44|-2.53|.586
72350851|NCT01450761|144222474|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.936||||0.3775|TWO_SIDED|95.0|0.807|1.085|||Log Rank||HR = ipilimumab over placebo|||1.085|0.807|0.3775
72350852|NCT01450761|144222475|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.961||||0.5678|TWO_SIDED|95.0|0.838|1.102|||Log Rank||HR = ipilimumab over placebo|||1.102|0.838|0.5678
72350853|NCT01450761|144222476|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.851||||0.0161|TWO_SIDED|95.0|0.747|0.971|||Log Rank||HR = ipilimumab over placebo|||0.971|0.747|0.0161
72350854|NCT04308941|144222487|OTHER|The mean and standard deviation was analyzed.||||||0.07|||||||Wilcoxon (Mann-Whitney)|||||||0.07
72350855|NCT00740207|144222491|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2||||0.7142|TWO_SIDED|95.0|-1.3|0.9|||t-test, 2 sided|||Paired t-test to compare difference between the investigational product's mean change from predose to postdose||0.9|-1.3|0.7142
72350856|NCT00740207|144222492|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-40.0||||0.1698|TWO_SIDED|95.0|-79.2|-0.8|||Fisher Exact|||Paired t-test to compare the difference in percentage between the portions of patients who had motion artifacts.||-0.8|-79.2|0.1698
72350857|NCT00740207|144222493|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.0||||1|TWO_SIDED|95.0|-28.6|8.6|||Fisher Exact|||Paired t-test to compare difference in percentage between the number of participants requiring repeat injections||8.6|-28.6|1.000
72350858|NCT00216671|144222543|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority of early initiation was inferred if the upper 95% confidence boundary for the difference of change in PANSS total score from baseline in favor of the routine approach is less than 6.|Mean Difference (Net)|-1.13|STANDARD_ERROR_OF_MEAN|4.1||0.784|TWO_SIDED|95.0|-9.24|6.99||An ANCOVA model with treatment as factor was used. The comparison between the 2 treatment groups was performed based on the least-squares means obtained from the ANCOVA model.|ANCOVA|||Assuming a difference of 3 points in favor of early initiation of treatment with Risperdal Consta, a sample size of 87 subjects per treatment arm has a power of 80% to demonstrate non-inferiority at the 0.025-level (1-sided). It was expected that about 20% of randomized subjects had to be excluded from the per-protocol (PP) analysis. Therefore, 220 subjects were to be included.||6.99|-9.24|0.784
72350859|NCT00216671|144222546|SUPERIORITY_OR_OTHER|||||||0.8||||||The statistical test was interpreted at the 5% significance level.|Wilcoxon two sample test|||Between-group comparison of the change in CGI-S from baseline to endpoint was analyzed as is with no derived calculations. CGI-S scores were coded as follows: 0=normal, not at all ill, 1=borderline, etc. and 6=among the most extremely ill patients.The endpoint of the study was based on the Last Observation Carried Forward (LOCF) principle, i.e., it was defined as the last available visit during the study with non-missing data for a parameter (excluding the baseline value).||||0.800
72350860|NCT00216671|144222546|SUPERIORITY_OR_OTHER||||||<|0.001||||||The statistical test was interpreted at the 5% significance level.|Wilcoxon-signed-rank test|||Within-group comparison of the change in CGI-S from baseline to endpoint was analyzed as is with no derived calculations. CGI-S scores were coded as follows: 0=normal, not at all ill, 1=borderline, etc. and 6=among the most extremely ill patients.||||<0.001
72350861|NCT00216671|144222546|SUPERIORITY_OR_OTHER||||||<|0.001||||||The statistical test was interpreted at the 5% significance level.|Wilcoxon-signed-rank test|||Within-group comparison of the change in CGI-S from baseline to endpoint was analyzed as is with no derived calculations. CGI-S scores were coded as follows: 0=normal, not at all ill, 1=borderline, etc. and 6=among the most extremely ill patients.||||<0.001
72350862|NCT00216671|144222547|SUPERIORITY_OR_OTHER|||||||0.798||||||The statistical test was interpreted at the 5% significance level.|Wilcoxon two sample test|||Between-group comparison of the change in GAF from baseline to endpoint. The endpoint of the study was based on the Last Observation Carried Forward (LOCF) principle, i.e., it was defined as the last available visit during the study with non-missing data for a parameter (excluding the baseline value).||||0.798
72350863|NCT00216671|144222547|SUPERIORITY_OR_OTHER||||||<|0.001||||||The statistical test was interpreted at the 5% significance level.|Wilcoxon-signed-rank test|||Within-group comparison of the change in GAF from baseline to endpoint. The endpoint of the study was based on the Last Observation Carried Forward (LOCF) principle, i.e., it was defined as the last available visit during the study with non-missing data for a parameter (excluding the baseline value).||||<0.001
72350864|NCT00216671|144222547|SUPERIORITY_OR_OTHER||||||<|0.001||||||The statistical test was interpreted at the 5% significance level.|Wilcoxon-signed-rank test|||Within-group comparison of the change in GAF from baseline to endpoint. The endpoint of the study was based on the Last Observation Carried Forward (LOCF) principle, i.e., it was defined as the last available visit during the study with non-missing data for a parameter (excluding the baseline value).||||<0.001
72350865|NCT00216671|144222548|SUPERIORITY_OR_OTHER|||||||0.519||||||The statistical test was interpreted at the 5% significance level.|Wilcoxon two sample test|||Between-group comparison of the change in SF-12 PCS score from baseline to endpoint. The endpoint of the study was based on the Last Observation Carried Forward (LOCF) principle, i.e., it was defined as the last available visit during the study with non-missing data for a parameter (excluding the baseline value).||||0.519
72350866|NCT00216671|144222548|SUPERIORITY_OR_OTHER||||||<|0.001||||||The statistical test was interpreted at the 5% significance level.|Wilcoxon-signed-rank test|||Within-group comparison of the change in SF-12 PCS score from baseline to endpoint. The endpoint of the study was based on the Last Observation Carried Forward (LOCF) principle, i.e., it was defined as the last available visit during the study with non-missing data for a parameter (excluding the baseline value).||||<0.001
72350867|NCT00216671|144222548|SUPERIORITY_OR_OTHER||||||<|0.001||||||The statistical test was interpreted at the 5% significance level.|Wilcoxon-signed-rank test|||Within-group comparison of the change in SF-12 PCS score from baseline to endpoint. The endpoint of the study was based on the Last Observation Carried Forward (LOCF) principle, i.e., it was defined as the last available visit during the study with non-missing data for a parameter (excluding the baseline value).||||<0.001
72350868|NCT00216671|144222548|SUPERIORITY_OR_OTHER|||||||0.721||||||The statistical test was interpreted at the 5% significance level.|Wilcoxon two sample test|||Between-group comparison of the change in SF-12 MCS score from baseline to endpoint. The endpoint of the study was based on the Last Observation Carried Forward (LOCF) principle, i.e., it was defined as the last available visit during the study with non-missing data for a parameter (excluding the baseline value).||||0.721
72350869|NCT00216671|144222548|SUPERIORITY_OR_OTHER||||||<|0.001||||||The statistical test was interpreted at the 5% significance level.|Wilcoxon-signed-rank test|||Within-group comparison of the change in SF-12 MCS score from baseline to endpoint. The endpoint of the study was based on the Last Observation Carried Forward (LOCF) principle, i.e., it was defined as the last available visit during the study with non-missing data for a parameter (excluding the baseline value).||||<0.001
72350870|NCT00216671|144222548|SUPERIORITY_OR_OTHER||||||<|0.001||||||The statistical test was interpreted at the 5% significance level.|Wilcoxon-signed-rank test|||Within-group comparison of the change in SF-12 MCS score from baseline to endpoint. The endpoint of the study was based on the Last Observation Carried Forward (LOCF) principle, i.e., it was defined as the last available visit during the study with non-missing data for a parameter (excluding the baseline value).||||<0.001
72350871|NCT01843023|144222642|SUPERIORITY||Mean Difference (Final Values)|0.558|||<|0.05|TWO_SIDED||||||t-test, 2 sided|||||||<0.05
72350872|NCT01843023|144222644|SUPERIORITY||Mean Difference (Final Values)|0.722|||<|0.05|TWO_SIDED||||||t-test, 2 sided|||||||<0.05
72350873|NCT00226811|144222675|SUPERIORITY_OR_OTHER||CBR rate (percentage)|7.7||||||95.0|2.9|16.0|||||Clinical benefit response rate: percent of patients with confirmed complete response, confirmed partial response or stable disease for at least 24 wks according to Response Evaluation Criteria in Solid Tumors, relative to total treated patients|||16.0|2.9|
72350874|NCT00226811|144222680|SUPERIORITY_OR_OTHER||OR rate (percentage)|2.6||||||95.0|0.3|9.0|||||Percentage of patients with confirmed complete response or confirmed partial response according to the Response Evaluation Criteria in Solid Tumors (RECIST), relative to the total number of treated patients.|||9.0|0.3|
72350875|NCT01128426|144222692|SUPERIORITY_OR_OTHER|||||||0.98|||||||mid-p exact binomial method|||Abnormal involuntary movements: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.98
72350876|NCT01128426|144222692|SUPERIORITY_OR_OTHER||||||<|0.01|||||||mid-p exact binomial method|||Acute bronchiolitis due to RSV: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||<0.01
72350877|NCT01128426|144222692|SUPERIORITY_OR_OTHER|||||||0.99|||||||mid-p exact binomial method|||Acute febrile mucocutaneous lymph node syndrome: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0 .99
72350878|NCT01128426|144222692|SUPERIORITY_OR_OTHER|||||||0.05|||||||mid-p exact binomial method|||Acute otitis media: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.05
72350879|NCT01128426|144222692|SUPERIORITY_OR_OTHER|||||||0.2|||||||mid-p exact binomial method|||Acute pyelonephritis without RMN lesion: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0 .20
72350880|NCT01128426|144222692|SUPERIORITY_OR_OTHER|||||||0.79|||||||mid-p exact binomial method|||Alkalosis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.79
72350881|NCT01128426|144222692|SUPERIORITY_OR_OTHER|||||||0.16|||||||mid-p exact binomial method|||Apnea: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.16
72350882|NCT01128426|144222692|SUPERIORITY_OR_OTHER|||||||0.03|||||||mid-p exact binomial method|||Apparent life threatening event infant: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.03
72350883|NCT01128426|144222692|SUPERIORITY_OR_OTHER|||||||0.03|||||||mid-p exact binomial method|||Asthma, unspecified, unspecified status: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0 .03
72350884|NCT01128426|144222692|SUPERIORITY_OR_OTHER|||||||0.05|||||||mid-p exact binomial method|||Bronchiolitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.05
72350885|NCT01128426|144222692|SUPERIORITY_OR_OTHER|||||||0.5|||||||mid-p exact binomial method|||Bronchitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.50
72350886|NCT01128426|144222692|SUPERIORITY_OR_OTHER|||||||0.5|||||||mid-p exact binomial method|||Bronchospasm: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.50
72350887|NCT01128426|144222692|SUPERIORITY_OR_OTHER|||||||0.18|||||||mid-p exact binomial method|||Candidiasis of mouth: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.18
72350888|NCT01128426|144222692|SUPERIORITY_OR_OTHER|||||||0.98|||||||mid-p exact binomial method|||Cellulitis and abscess of trunk: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.98
72350889|NCT01128426|144222692|SUPERIORITY_OR_OTHER|||||||0.21|||||||mid-p exact binomial method|||Constipation: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.21
72350890|NCT01128426|144222692|SUPERIORITY_OR_OTHER|||||||0.03|||||||mid-p exact binomial method|||Croup: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.03
72350891|NCT01128426|144222692|SUPERIORITY_OR_OTHER|||||||0.01|||||||mid-p exact binomial method|||Dehydration: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.01
72350892|NCT01128426|144222692|SUPERIORITY_OR_OTHER|||||||0.21|||||||mid-p exact binomial method|||Dermatitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.21
72350893|NCT01128426|144222692|SUPERIORITY_OR_OTHER|||||||0.38|||||||mid-p exact binomial method|||Dyspnea: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.38
72350894|NCT01128426|144222692|SUPERIORITY_OR_OTHER|||||||0.7|||||||mid-p exact binomial method|||Failure to thrive: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.70
72350895|NCT01128426|144222692|SUPERIORITY_OR_OTHER||||||<|0.01|||||||mid-p exact binomial method|||Fever: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||<0.01
72350896|NCT01128426|144222692|SUPERIORITY_OR_OTHER|||||||0.33|||||||mid-p exact binomial method|||Fussy infant: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.33
72350897|NCT01128426|144222692|SUPERIORITY_OR_OTHER|||||||0.03|||||||mid-p exact binomial method|||Gastroenteritis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.03
72350898|NCT01128426|144222692|SUPERIORITY_OR_OTHER|||||||0.67|||||||mid-p exact binomial method|||Hypopotassemia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.67
72350899|NCT01128426|144222692|SUPERIORITY_OR_OTHER|||||||0.5|||||||mid-p exact binomial method|||Lipoma of other specified sites: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.50
72350900|NCT01128426|144222692|SUPERIORITY_OR_OTHER|||||||0.52|||||||mid-p exact binomial method|||Methicillin susceptible Staphylococcus aureus: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.52
72350901|NCT01128426|144222692|SUPERIORITY_OR_OTHER|||||||0.5|||||||mid-p exact binomial method|||Nausea and vomiting: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.50
72350902|NCT01128426|144222692|SUPERIORITY_OR_OTHER||||||<|0.01|||||||mid-p exact binomial method|||Neonatal bradycardia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||<0.01
72350903|NCT01128426|144222692|SUPERIORITY_OR_OTHER|||||||0.03|||||||mid-p exact binomial method|||Neonatal candida infection: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.03
72350904|NCT01128426|144222692|SUPERIORITY_OR_OTHER|||||||0.26|||||||mid-p exact binomial method|||Other diseases of nasal cavity and sinuses: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.26
72350905|NCT01128426|144222692|SUPERIORITY_OR_OTHER|||||||0.98|||||||mid-p exact binomial method|||Other specified cardiac dysrhythmias: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.98
72350906|NCT01128426|144222692|SUPERIORITY_OR_OTHER||||||<|0.01|||||||mid-p exact binomial method|||Pilonidal cyst without mention of abscess: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||<0.01
72350907|NCT01128426|144222692|SUPERIORITY_OR_OTHER|||||||0.09|||||||mid-p exact binomial method|||Pneumonia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.09
72350908|NCT01128426|144222692|SUPERIORITY_OR_OTHER||||||<|0.01|||||||mid-p exact binomial method|||Primary apnea of newborn: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||<0.01
72350909|NCT01128426|144222692|SUPERIORITY_OR_OTHER|||||||0.04|||||||mid-p exact binomial method|||Rash: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.04
72350910|NCT01128426|144222692|SUPERIORITY_OR_OTHER|||||||0.02|||||||mid-p exact binomial method|||Respiratory syncytial virus: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.02
72350911|NCT01128426|144222692|SUPERIORITY_OR_OTHER|||||||0.71|||||||mid-p exact binomial method|||Retinopathy of prematurity stage 2: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.71
72350912|NCT01128426|144222692|SUPERIORITY_OR_OTHER|||||||0.83|||||||mid-p exact binomial method|||Single seizure: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.83
72350913|NCT01128426|144222692|SUPERIORITY_OR_OTHER|||||||0.74|||||||mid-p exact binomial method|||Stridor: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.74
72350914|NCT01128426|144222692|SUPERIORITY_OR_OTHER|||||||0.05|||||||mid-p exact binomial method|||Umbilical hernia without obstruction/gangrene: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.05
72350915|NCT01128426|144222692|SUPERIORITY_OR_OTHER|||||||0.23|||||||mid-p exact binomial method|||Unspecified bacterial pneumonia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.23
72350916|NCT01128426|144222692|SUPERIORITY_OR_OTHER|||||||0.79|||||||mid-p exact binomial method|||Unspecified septicemia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.79
72350917|NCT01128426|144222692|SUPERIORITY_OR_OTHER||||||<|0.01|||||||mid-p exact binomial method|||Urinary tract infection: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||<0.01
72350918|NCT01128426|144222692|SUPERIORITY_OR_OTHER|||||||0.04|||||||mid-p exact binomial method|||Viral syndrome: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.04
72350919|NCT01128426|144222692|SUPERIORITY_OR_OTHER|||||||0.25|||||||mid-p exact binomial method|||Weakness: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.25
72350920|NCT01128426|144222693|SUPERIORITY_OR_OTHER|||||||0.63|||||||mid-p exact binomial method|||Abnormal involuntary movements: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.63
72350921|NCT01128426|144222693|SUPERIORITY_OR_OTHER||||||<|0.01|||||||mid-p exact binomial method|||Acute bronchiolitis due to RSV: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||<0.01
72350922|NCT01128426|144222693|SUPERIORITY_OR_OTHER|||||||0.04|||||||mid-p exact binomial method|||Acute otitis media: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.04
72350923|NCT01128426|144222693|SUPERIORITY_OR_OTHER|||||||0.5|||||||mid-p exact binomial method|||Acute pyelonephritis without RMN lesion: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.50
72350924|NCT01128426|144222693|SUPERIORITY_OR_OTHER|||||||0.99|||||||mid-p exact binomial method|||Adverse drug reaction: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.99
72350925|NCT01128426|144222693|SUPERIORITY_OR_OTHER|||||||0.5|||||||mid-p exact binomial method|||Alkalosis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.50
72350926|NCT01128426|144222693|SUPERIORITY_OR_OTHER|||||||0.61|||||||mid-p exact binomial method|||Apnea: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.61
72350927|NCT01128426|144222693|SUPERIORITY_OR_OTHER|||||||0.42|||||||mid-p exact binomial method|||Apparent life threatening event infant: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.42
72350928|NCT01128426|144222693|SUPERIORITY_OR_OTHER|||||||0.5|||||||mid-p exact binomial method|||Asthma with acute exacerbation: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.50
72350929|NCT01128426|144222693|SUPERIORITY_OR_OTHER|||||||0.71|||||||mid-p exact binomial method|||Asthma, unspecified, unspecified status: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.71
72350930|NCT01128426|144222693|SUPERIORITY_OR_OTHER|||||||0.36|||||||mid-p exact binomial method|||Bronchiolitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.36
72350931|NCT01128426|144222693|SUPERIORITY_OR_OTHER|||||||0.37|||||||mid-p exact binomial method|||Bronchitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.37
72350932|NCT01128426|144222693|SUPERIORITY_OR_OTHER|||||||0.19|||||||mid-p exact binomial method|||Bronchospasm: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.19
72350933|NCT01128426|144222693|SUPERIORITY_OR_OTHER||||||<|0.01|||||||mid-p exact binomial method|||Candidiasis of mouth: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||<0.01
72350934|NCT01128426|144222693|SUPERIORITY_OR_OTHER||||||<|0.01|||||||mid-p exact binomial method|||Constipation: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||<0.01
72350935|NCT01128426|144222693|SUPERIORITY_OR_OTHER||||||<|0.01|||||||mid-p exact binomial method|||Croup: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||<0.01
72350936|NCT01128426|144222693|SUPERIORITY_OR_OTHER|||||||0.77|||||||mid-p exact binomial method|||Dehydration: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.77
72350937|NCT01128426|144222693|SUPERIORITY_OR_OTHER|||||||0.07|||||||mid-p exact binomial method|||Dermatitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.07
72350938|NCT01128426|144222693|SUPERIORITY_OR_OTHER|||||||0.41|||||||mid-p exact binomial method|||Dyspnea: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.41
72350939|NCT01128426|144222693|SUPERIORITY_OR_OTHER|||||||0.63|||||||mid-p exact binomial method|||Failure to thrive: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.63
72350940|NCT01128426|144222693|SUPERIORITY_OR_OTHER||||||<|0.01|||||||mid-p exact binomial method|||Fever: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||<0.01
72350941|NCT01128426|144222693|SUPERIORITY_OR_OTHER|||||||0.04|||||||mid-p exact binomial method|||Fussy infant: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.04
72350942|NCT01128426|144222693|SUPERIORITY_OR_OTHER|||||||0.75|||||||mid-p exact binomial method|||Gastroenteritis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.75
72350943|NCT01128426|144222693|SUPERIORITY_OR_OTHER|||||||0.99|||||||mid-p exact binomial method|||Hematoma: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.99
72350944|NCT01128426|144222693|SUPERIORITY_OR_OTHER|||||||0.5|||||||mid-p exact binomial method|||Methicillin susceptible Staphylococcus aureus: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.50
72350945|NCT01128426|144222693|SUPERIORITY_OR_OTHER||||||<|0.01|||||||mid-p exact binomial method|||Nausea and vomiting: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||<0.01
72350946|NCT01128426|144222693|SUPERIORITY_OR_OTHER|||||||0.01|||||||mid-p exact binomial method|||Neonatal candida infection: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.01
72350947|NCT01128426|144222693|SUPERIORITY_OR_OTHER||||||<|0.01|||||||mid-p exact binomial method|||Other diseases of nasal cavity and sinuses: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||<0.01
72350948|NCT01128426|144222693|SUPERIORITY_OR_OTHER|||||||0.12|||||||mid-p exact binomial method|||Other specified cardiac dysrhythmias: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.12
72350949|NCT01128426|144222693|SUPERIORITY_OR_OTHER|||||||0.83|||||||mid-p exact binomial method|||Pneumonia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.83
72350950|NCT01128426|144222693|SUPERIORITY_OR_OTHER|||||||0.12|||||||mid-p exact binomial method|||Primary apnea of newborn: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.12
72350951|NCT01128426|144222693|SUPERIORITY_OR_OTHER|||||||0.26|||||||mid-p exact binomial method|||Rash: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.26
72350952|NCT01128426|144222693|SUPERIORITY_OR_OTHER|||||||0.83|||||||mid-p exact binomial method|||Respiratory syncytial virus: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.83
72350953|NCT01128426|144222693|SUPERIORITY_OR_OTHER|||||||0.98|||||||mid-p exact binomial method|||Single seizure: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.98
72350954|NCT01128426|144222693|SUPERIORITY_OR_OTHER|||||||0.5|||||||mid-p exact binomial method|||Stomatitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.50
72350955|NCT01128426|144222693|SUPERIORITY_OR_OTHER|||||||0.06|||||||mid-p exact binomial method|||Stridor: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.06
72350956|NCT01128426|144222693|SUPERIORITY_OR_OTHER|||||||0.63|||||||mid-p exact binomial method|||Subconjunctival hemorrhage: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.63
72350957|NCT01128426|144222693|SUPERIORITY_OR_OTHER||||||<|0.01|||||||mid-p exact binomial method|||Umbilical hernia without obstruction/gangrene: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||<0.01
72350958|NCT01128426|144222693|SUPERIORITY_OR_OTHER|||||||0.74|||||||mid-p exact binomial method|||Unspecified septicemia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.74
72350959|NCT01128426|144222693|SUPERIORITY_OR_OTHER|||||||0.66|||||||mid-p exact binomial method|||Urinary tract infection: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.66
72350960|NCT01128426|144222693|SUPERIORITY_OR_OTHER|||||||0.13|||||||mid-p exact binomial method|||Urticaria: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.13
72350961|NCT01128426|144222693|SUPERIORITY_OR_OTHER|||||||0.13|||||||mid-p exact binomial method|||Vaccines adverse reaction: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.13
72350962|NCT01128426|144222693|SUPERIORITY_OR_OTHER|||||||0.53|||||||mid-p exact binomial method|||Viral syndrome: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.53
72350963|NCT01128426|144222693|SUPERIORITY_OR_OTHER|||||||0.62|||||||mid-p exact binomial method|||Weakness: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.62
72350964|NCT01128426|144222693|SUPERIORITY_OR_OTHER|||||||0.77|||||||mid-p exact binomial method|||Wheezing: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.77
72350965|NCT01128426|144222694|SUPERIORITY_OR_OTHER|||||||0.77|||||||mid-p exact binomial method|||Abnormal involuntary movements: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.77
72350966|NCT01128426|144222694|SUPERIORITY_OR_OTHER||||||<|0.01|||||||mid-p exact binomial method|||Acute bronchiolitis due to RSV: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||<0.01
72350967|NCT01128426|144222694|SUPERIORITY_OR_OTHER|||||||0.99|||||||mid-p exact binomial method|||Acute febrile mucocutaneous lymph node syndrome: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.99
72350968|NCT01128426|144222694|SUPERIORITY_OR_OTHER|||||||0.63|||||||mid-p exact binomial method|||Acute otitis media: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.63
72350969|NCT01128426|144222694|SUPERIORITY_OR_OTHER|||||||0.2|||||||mid-p exact binomial method|||Acute pyelonephritis without RMN lesion: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.20
72350970|NCT01128426|144222694|SUPERIORITY_OR_OTHER|||||||0.99|||||||mid-p exact binomial method|||Adverse drug reaction: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.99
72350971|NCT01128426|144222694|SUPERIORITY_OR_OTHER|||||||0.79|||||||mid-p exact binomial method|||Alkalosis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.79
72350972|NCT01128426|144222694|SUPERIORITY_OR_OTHER|||||||0.09|||||||mid-p exact binomial method|||Apnea: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.09
72350973|NCT01128426|144222694|SUPERIORITY_OR_OTHER|||||||0.03|||||||mid-p exact binomial method|||Apparent life threatening event infant: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.03
72350974|NCT01128426|144222694|SUPERIORITY_OR_OTHER|||||||0.5|||||||mid-p exact binomial method|||Asthma with acute exacerbation: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.50
72350975|NCT01128426|144222694|SUPERIORITY_OR_OTHER|||||||0.4|||||||mid-p exact binomial method|||Asthma, unspecified, unspecified status: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.40
72350976|NCT01128426|144222694|SUPERIORITY_OR_OTHER|||||||0.07|||||||mid-p exact binomial method|||Bronchiolitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.07
72350977|NCT01128426|144222694|SUPERIORITY_OR_OTHER|||||||0.67|||||||mid-p exact binomial method|||Bronchitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.67
72350978|NCT01128426|144222694|SUPERIORITY_OR_OTHER|||||||0.36|||||||mid-p exact binomial method|||Bronchospasm: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.36
72350979|NCT01128426|144222694|SUPERIORITY_OR_OTHER||||||<|0.01|||||||mid-p exact binomial method|||Candidiasis of mouth: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||<0.01
72350980|NCT01128426|144222694|SUPERIORITY_OR_OTHER|||||||0.98|||||||mid-p exact binomial method|||Cellulitis and abscess of trunk: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.98
72350981|NCT01128426|144222694|SUPERIORITY_OR_OTHER||||||<|0.01|||||||mid-p exact binomial method|||Constipation: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||<0.01
72350982|NCT01128426|144222694|SUPERIORITY_OR_OTHER||||||<|0.01|||||||mid-p exact binomial method|||Croup: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||<0.01
72350983|NCT01128426|144222694|SUPERIORITY_OR_OTHER|||||||0.03|||||||mid-p exact binomial method|||Dehydration: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.03
72350984|NCT01128426|144222694|SUPERIORITY_OR_OTHER|||||||0.04|||||||mid-p exact binomial method|||Dermatitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.04
72350985|NCT01128426|144222694|SUPERIORITY_OR_OTHER|||||||0.33|||||||mid-p exact binomial method|||Dyspnea: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.33
72350986|NCT01128426|144222694|SUPERIORITY_OR_OTHER|||||||0.71|||||||mid-p exact binomial method|||Failure to thrive: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.71
72350987|NCT01128426|144222694|SUPERIORITY_OR_OTHER||||||<|0.01|||||||mid-p exact binomial method|||Fever: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||<0.01
72350988|NCT01128426|144222694|SUPERIORITY_OR_OTHER|||||||0.02|||||||mid-p exact binomial method|||Fussy infant: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.02
72350989|NCT01128426|144222694|SUPERIORITY_OR_OTHER|||||||0.13|||||||mid-p exact binomial method|||Gastroenteritis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.13
72350990|NCT01128426|144222694|SUPERIORITY_OR_OTHER|||||||0.99|||||||mid-p exact binomial method|||Hematoma: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.99
72350991|NCT01128426|144222694|SUPERIORITY_OR_OTHER|||||||0.67|||||||mid-p exact binomial method|||Hypopotassemia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.67
72350992|NCT01128426|144222694|SUPERIORITY_OR_OTHER|||||||0.5|||||||mid-p exact binomial method|||Lipoma of other specified sites: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.50
72350993|NCT01128426|144222694|SUPERIORITY_OR_OTHER|||||||0.77|||||||mid-p exact binomial method|||Methicillin susceptible Staphylococcus aureus: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.77
72350994|NCT01128426|144222694|SUPERIORITY_OR_OTHER||||||<|0.01|||||||mid-p exact binomial method|||Nausea and vomiting: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||<0.01
72350995|NCT01128426|144222694|SUPERIORITY_OR_OTHER||||||<|0.01|||||||mid-p exact binomial method|||Neonatal bradycardia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||<0.01
72350996|NCT01128426|144222694|SUPERIORITY_OR_OTHER||||||<|0.01|||||||mid-p exact binomial method|||Neonatal candida infection: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||<0.01
72350997|NCT01128426|144222694|SUPERIORITY_OR_OTHER||||||<|0.01|||||||mid-p exact binomial method|||Other diseases of nasal cavity and sinuses: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||<0.01
72350998|NCT01128426|144222694|SUPERIORITY_OR_OTHER|||||||0.61|||||||mid-p exact binomial method|||Other specified cardiac dysrhythmias: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.61
72350999|NCT01128426|144222694|SUPERIORITY_OR_OTHER||||||<|0.01|||||||mid-p exact binomial method|||Pilonidal cyst without mention of abscess: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||<0.01
72351000|NCT01128426|144222694|SUPERIORITY_OR_OTHER|||||||0.33|||||||mid-p exact binomial method|||Pneumonia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.33
72351001|NCT01128426|144222694|SUPERIORITY_OR_OTHER||||||<|0.01|||||||mid-p exact binomial method|||Primary apnea of newborn: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||<0.01
72351002|NCT01128426|144222694|SUPERIORITY_OR_OTHER|||||||0.05|||||||mid-p exact binomial method|||Rash: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.05
72351003|NCT01128426|144222694|SUPERIORITY_OR_OTHER|||||||0.38|||||||mid-p exact binomial method|||Respiratory syncytial virus: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.38
72351004|NCT01128426|144222694|SUPERIORITY_OR_OTHER|||||||0.71|||||||mid-p exact binomial method|||Retinopathy of prematurity stage 2: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.71
72351005|NCT01128426|144222694|SUPERIORITY_OR_OTHER|||||||0.97|||||||mid-p exact binomial method|||Single seizure: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.97
72351006|NCT01128426|144222694|SUPERIORITY_OR_OTHER|||||||0.5|||||||mid-p exact binomial method|||Stomatitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.50
72351007|NCT01128426|144222694|SUPERIORITY_OR_OTHER|||||||0.26|||||||mid-p exact binomial method|||Stridor: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.26
72351008|NCT01128426|144222694|SUPERIORITY_OR_OTHER|||||||0.63|||||||mid-p exact binomial method|||Subconjunctival hemorrhage: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.63
72351009|NCT01128426|144222694|SUPERIORITY_OR_OTHER||||||<|0.01|||||||mid-p exact binomial method|||Umbilical hernia without obstruction/gangrene: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||<0.01
72351010|NCT01128426|144222694|SUPERIORITY_OR_OTHER|||||||0.23|||||||mid-p exact binomial method|||Unspecified bacterial pneumonia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.23
72351011|NCT01128426|144222694|SUPERIORITY_OR_OTHER|||||||0.85|||||||mid-p exact binomial method|||Unspecified septicemia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.85
72351012|NCT01128426|144222694|SUPERIORITY_OR_OTHER|||||||0.02|||||||mid-p exact binomial method|||Urinary tract infection: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.02
72351013|NCT01128426|144222694|SUPERIORITY_OR_OTHER|||||||0.13|||||||mid-p exact binomial method|||Urticaria: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.13
72351014|NCT01128426|144222694|SUPERIORITY_OR_OTHER|||||||0.13|||||||mid-p exact binomial method|||Vaccines adverse reaction: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.13
72351015|NCT01128426|144222694|SUPERIORITY_OR_OTHER|||||||0.09|||||||mid-p exact binomial method|||Viral syndrome: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.09
72351016|NCT01128426|144222694|SUPERIORITY_OR_OTHER|||||||0.99|||||||mid-p exact binomial method|||Weakness: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.99
72351017|NCT01128426|144222694|SUPERIORITY_OR_OTHER|||||||0.77|||||||mid-p exact binomial method|||Wheezing: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.77
72351018|NCT01128426|144222695|SUPERIORITY_OR_OTHER|||||||0.14|||||||mid-p exact binomial method|||Abnormal involuntary movements: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.14
72351019|NCT01128426|144222695|SUPERIORITY_OR_OTHER||||||<|0.01|||||||mid-p exact binomial method|||Acute bronchiolitis due to RSV: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||<0.01
72351020|NCT01128426|144222695|SUPERIORITY_OR_OTHER|||||||0.95|||||||mid-p exact binomial method|||Acute febrile mucocutaneous lymph node syndrome: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.95
72351021|NCT01128426|144222695|SUPERIORITY_OR_OTHER|||||||0.91|||||||mid-p exact binomial method|||Acute otitis media: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.91
72351022|NCT01128426|144222695|SUPERIORITY_OR_OTHER|||||||0.86|||||||mid-p exact binomial method|||Acute pyelonephritis without RMN lesion: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.86
72351023|NCT01128426|144222695|SUPERIORITY_OR_OTHER|||||||0.02|||||||mid-p exact binomial method|||Alkalosis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.02
72351024|NCT01128426|144222695|SUPERIORITY_OR_OTHER|||||||0.13|||||||mid-p exact binomial method|||Apnea: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.13
72351025|NCT01128426|144222695|SUPERIORITY_OR_OTHER|||||||0.11|||||||mid-p exact binomial method|||Apparent life threatening event infant: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.11
72351026|NCT01128426|144222695|SUPERIORITY_OR_OTHER|||||||0.04|||||||mid-p exact binomial method|||Asthma, unspecified, unspecified status: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.04
72351027|NCT01128426|144222695|SUPERIORITY_OR_OTHER|||||||0.27|||||||mid-p exact binomial method|||Bronchiolitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.27
72351028|NCT01128426|144222695|SUPERIORITY_OR_OTHER|||||||0.52|||||||mid-p exact binomial method|||Bronchitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.52
72351029|NCT01128426|144222695|SUPERIORITY_OR_OTHER|||||||0.05|||||||mid-p exact binomial method|||Candidiasis of mouth: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.05
72351030|NCT01128426|144222695|SUPERIORITY_OR_OTHER|||||||0.42|||||||mid-p exact binomial method|||Cellulitis and abscess of trunk: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.42
72351031|NCT01128426|144222695|SUPERIORITY_OR_OTHER|||||||0.33|||||||mid-p exact binomial method|||Constipation: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.33
72351032|NCT01128426|144222695|SUPERIORITY_OR_OTHER|||||||0.88|||||||mid-p exact binomial method|||Croup: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.88
72351033|NCT01128426|144222695|SUPERIORITY_OR_OTHER|||||||0.79|||||||mid-p exact binomial method|||Dehydration: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.79
72351034|NCT01128426|144222695|SUPERIORITY_OR_OTHER|||||||0.57|||||||mid-p exact binomial method|||Dermatitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.57
72351035|NCT01128426|144222695|SUPERIORITY_OR_OTHER|||||||0.24|||||||mid-p exact binomial method|||Dyspnea: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.24
72351036|NCT01128426|144222695|SUPERIORITY_OR_OTHER|||||||0.25|||||||mid-p exact binomial method|||Failure to thrive: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.25
72351037|NCT01128426|144222695|SUPERIORITY_OR_OTHER|||||||0.14|||||||mid-p exact binomial method|||Fever: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.14
72351038|NCT01128426|144222695|SUPERIORITY_OR_OTHER|||||||0.42|||||||mid-p exact binomial method|||Fussy infant: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.42
72351039|NCT01128426|144222695|SUPERIORITY_OR_OTHER|||||||0.23|||||||mid-p exact binomial method|||Gastroenteritis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.23
72351040|NCT01128426|144222695|SUPERIORITY_OR_OTHER|||||||0.27|||||||mid-p exact binomial method|||Hypopotassemia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.27
72351041|NCT01128426|144222695|SUPERIORITY_OR_OTHER|||||||0.57|||||||mid-p exact binomial method|||Lipoma of other specified sites: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.57
72351042|NCT01128426|144222695|SUPERIORITY_OR_OTHER|||||||0.15|||||||mid-p exact binomial method|||Methicillin susceptible Staphylococcus aureus: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.15
72351043|NCT01128426|144222695|SUPERIORITY_OR_OTHER|||||||0.48|||||||mid-p exact binomial method|||Nausea and vomiting: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.48
72351044|NCT01128426|144222695|SUPERIORITY_OR_OTHER|||||||0.08|||||||mid-p exact binomial method|||Neonatal bradycardia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.08
72351045|NCT01128426|144222695|SUPERIORITY_OR_OTHER|||||||0.46|||||||mid-p exact binomial method|||Other diseases of nasal cavity and sinuses: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.46
72351046|NCT01128426|144222695|SUPERIORITY_OR_OTHER|||||||0.14|||||||mid-p exact binomial method|||Other specified cardiac dysrhythmias: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.14
72351047|NCT01128426|144222695|SUPERIORITY_OR_OTHER||||||<|0.01|||||||mid-p exact binomial method|||Pilonidal cyst without mention of abscess: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||<0.01
72351048|NCT01128426|144222695|SUPERIORITY_OR_OTHER|||||||0.88|||||||mid-p exact binomial method|||Pneumonia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.88
72351049|NCT01128426|144222695|SUPERIORITY_OR_OTHER|||||||0.04|||||||mid-p exact binomial method|||Primary apnea of newborn: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.04
72351050|NCT01128426|144222695|SUPERIORITY_OR_OTHER|||||||0.93|||||||mid-p exact binomial method|||Rash: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.93
72351051|NCT01128426|144222695|SUPERIORITY_OR_OTHER|||||||0.95|||||||mid-p exact binomial method|||Respiratory syncytial virus: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.95
72351052|NCT01128426|144222695|SUPERIORITY_OR_OTHER|||||||0.14|||||||mid-p exact binomial method|||Retinopathy of prematurity stage 2: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.14
72351053|NCT01128426|144222695|SUPERIORITY_OR_OTHER|||||||0.38|||||||mid-p exact binomial method|||Single seizure: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.38
72351054|NCT01128426|144222695|SUPERIORITY_OR_OTHER|||||||0.9|||||||mid-p exact binomial method|||Stridor: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.90
72351055|NCT01128426|144222695|SUPERIORITY_OR_OTHER|||||||0.11|||||||mid-p exact binomial method|||Umbilical hernia without obstruction/gangrene: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.11
72351056|NCT01128426|144222695|SUPERIORITY_OR_OTHER|||||||0.08|||||||mid-p exact binomial method|||Unspecified bacterial pneumonia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.08
72351057|NCT01128426|144222695|SUPERIORITY_OR_OTHER|||||||0.09|||||||mid-p exact binomial method|||Unspecified septicemia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.09
72351058|NCT01128426|144222695|SUPERIORITY_OR_OTHER|||||||0.34|||||||mid-p exact binomial method|||Urinary tract infection: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.34
72351059|NCT01128426|144222695|SUPERIORITY_OR_OTHER|||||||0.92|||||||mid-p exact binomial method|||Viral syndrome: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.92
72351060|NCT01128426|144222695|SUPERIORITY_OR_OTHER|||||||0.27|||||||mid-p exact binomial method|||Weakness: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.27
72351061|NCT01128426|144222696|SUPERIORITY_OR_OTHER|||||||0.62|||||||mid-p exact binomial method|||Abnormal involuntary movements: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.62
72351062|NCT01128426|144222696|SUPERIORITY_OR_OTHER|||||||0.49|||||||mid-p exact binomial method|||Acute bronchiolitis due to RSV: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.49
72351063|NCT01128426|144222696|SUPERIORITY_OR_OTHER|||||||0.15|||||||mid-p exact binomial method|||Acute otitis media: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.15
72351064|NCT01128426|144222696|SUPERIORITY_OR_OTHER|||||||0.52|||||||mid-p exact binomial method|||Adverse drug reaction: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.52
72351065|NCT01128426|144222696|SUPERIORITY_OR_OTHER|||||||0.52|||||||mid-p exact binomial method|||Alkalosis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.52
72351066|NCT01128426|144222696|SUPERIORITY_OR_OTHER|||||||0.14|||||||mid-p exact binomial method|||Apnea: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.14
72351067|NCT01128426|144222696|SUPERIORITY_OR_OTHER|||||||0.11|||||||mid-p exact binomial method|||Apparent life threatening event infant: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.11
72351068|NCT01128426|144222696|SUPERIORITY_OR_OTHER|||||||0.52|||||||mid-p exact binomial method|||Asthma with acute exacerbation: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.52
72351069|NCT01128426|144222696|SUPERIORITY_OR_OTHER|||||||0.01|||||||mid-p exact binomial method|||Asthma, unspecified, unspecified status: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.01
72351070|NCT01128426|144222696|SUPERIORITY_OR_OTHER|||||||0.05|||||||mid-p exact binomial method|||Bronchiolitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.05
72351071|NCT01128426|144222696|SUPERIORITY_OR_OTHER|||||||0.95|||||||mid-p exact binomial method|||Bronchitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.95
72351072|NCT01128426|144222696|SUPERIORITY_OR_OTHER|||||||0.35|||||||mid-p exact binomial method|||Bronchospasm: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.35
72351073|NCT01128426|144222696|SUPERIORITY_OR_OTHER|||||||0.68|||||||mid-p exact binomial method|||Candidiasis of mouth: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.68
72351074|NCT01128426|144222696|SUPERIORITY_OR_OTHER|||||||0.51|||||||mid-p exact binomial method|||Constipation: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.51
72351075|NCT01128426|144222696|SUPERIORITY_OR_OTHER|||||||0.14|||||||mid-p exact binomial method|||Croup: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.14
72351076|NCT01128426|144222696|SUPERIORITY_OR_OTHER|||||||0.35|||||||mid-p exact binomial method|||Dehydration: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.35
72351077|NCT01128426|144222696|SUPERIORITY_OR_OTHER|||||||0.01|||||||mid-p exact binomial method|||Dermatitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.01
72351078|NCT01128426|144222696|SUPERIORITY_OR_OTHER|||||||0.3|||||||mid-p exact binomial method|||Dyspnea: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.30
72351079|NCT01128426|144222696|SUPERIORITY_OR_OTHER|||||||0.27|||||||mid-p exact binomial method|||Failure to thrive: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.27
72351080|NCT01128426|144222696|SUPERIORITY_OR_OTHER|||||||0.02|||||||mid-p exact binomial method|||Fever: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.02
72351081|NCT01128426|144222696|SUPERIORITY_OR_OTHER|||||||0.45|||||||mid-p exact binomial method|||Fussy infant: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.45
72351082|NCT01128426|144222696|SUPERIORITY_OR_OTHER|||||||0.66|||||||mid-p exact binomial method|||Gastroenteritis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.66
72351083|NCT01128426|144222696|SUPERIORITY_OR_OTHER|||||||0.48|||||||mid-p exact binomial method|||Hand, foot and mouth disease: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.48
72351084|NCT01128426|144222696|SUPERIORITY_OR_OTHER|||||||0.95|||||||mid-p exact binomial method|||Hematoma: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.95
72351085|NCT01128426|144222696|SUPERIORITY_OR_OTHER|||||||0.17|||||||mid-p exact binomial method|||Nausea and vomiting: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.17
72351086|NCT01128426|144222696|SUPERIORITY_OR_OTHER|||||||0.68|||||||mid-p exact binomial method|||Neonatal candida infection: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.68
72351087|NCT01128426|144222696|SUPERIORITY_OR_OTHER|||||||0.23|||||||mid-p exact binomial method|||Other diseases of nasal cavity and sinuses: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.23
72351088|NCT01128426|144222696|SUPERIORITY_OR_OTHER|||||||0.48|||||||mid-p exact binomial method|||Other specified cardiac dysrhythmias: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.48
72351089|NCT01128426|144222696|SUPERIORITY_OR_OTHER|||||||0.12|||||||mid-p exact binomial method|||Pneumonia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.12
72351090|NCT01128426|144222696|SUPERIORITY_OR_OTHER|||||||0.92|||||||mid-p exact binomial method|||Rash: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.92
72351091|NCT01128426|144222696|SUPERIORITY_OR_OTHER|||||||0.09|||||||mid-p exact binomial method|||Respiratory syncytial virus: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.09
72351092|NCT01128426|144222696|SUPERIORITY_OR_OTHER|||||||0.87|||||||mid-p exact binomial method|||Single seizure: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.87
72351093|NCT01128426|144222696|SUPERIORITY_OR_OTHER|||||||0.48|||||||mid-p exact binomial method|||Stridor: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.48
72351094|NCT01128426|144222696|SUPERIORITY_OR_OTHER|||||||0.27|||||||mid-p exact binomial method|||Subconjunctival hemorrhage: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.27
72351095|NCT01128426|144222696|SUPERIORITY_OR_OTHER|||||||0.68|||||||mid-p exact binomial method|||Umbilical hernia without obstruction/gangrene: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.68
72351096|NCT01128426|144222696|SUPERIORITY_OR_OTHER|||||||0.52|||||||mid-p exact binomial method|||Unspecified septicemia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.52
72351097|NCT01128426|144222696|SUPERIORITY_OR_OTHER||||||<|0.01|||||||mid-p exact binomial method|||Urinary tract infection: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||<0.01
72351098|NCT01128426|144222696|SUPERIORITY_OR_OTHER|||||||0.91|||||||mid-p exact binomial method|||Urticaria: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.91
72351099|NCT01128426|144222696|SUPERIORITY_OR_OTHER|||||||0.14|||||||mid-p exact binomial method|||Vaccines adverse reaction: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.14
72351100|NCT01128426|144222696|SUPERIORITY_OR_OTHER|||||||0.03|||||||mid-p exact binomial method|||Viral syndrome: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.03
72351101|NCT01128426|144222696|SUPERIORITY_OR_OTHER|||||||0.52|||||||mid-p exact binomial method|||Weakness: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.52
72351102|NCT01128426|144222696|SUPERIORITY_OR_OTHER|||||||0.25|||||||mid-p exact binomial method|||Wheezing: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.25
72351103|NCT01128426|144222697|SUPERIORITY_OR_OTHER|||||||0.59|||||||mid-p exact binomial method|||Abnormal involuntary movements: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.59
72351104|NCT01128426|144222697|SUPERIORITY_OR_OTHER|||||||0.02|||||||mid-p exact binomial method|||Acute bronchiolitis due to RSV: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.02
72351105|NCT01128426|144222697|SUPERIORITY_OR_OTHER|||||||0.95|||||||mid-p exact binomial method|||Acute febrile mucocutaneous lymph node syndrome: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.95
72351106|NCT01128426|144222697|SUPERIORITY_OR_OTHER|||||||0.28|||||||mid-p exact binomial method|||Acute otitis media: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.28
72351107|NCT01128426|144222697|SUPERIORITY_OR_OTHER|||||||0.86|||||||mid-p exact binomial method|||Acute pyelonephritis without RMN lesion: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.86
72351108|NCT01128426|144222697|SUPERIORITY_OR_OTHER|||||||0.52|||||||mid-p exact binomial method|||Adverse drug reaction: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.52
72351109|NCT01128426|144222697|SUPERIORITY_OR_OTHER|||||||0.02|||||||mid-p exact binomial method|||Alkalosis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.02
72351110|NCT01128426|144222697|SUPERIORITY_OR_OTHER|||||||0.1|||||||mid-p exact binomial method|||Apnea: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.10
72351111|NCT01128426|144222697|SUPERIORITY_OR_OTHER|||||||0.06|||||||mid-p exact binomial method|||Apparent life threatening event infant: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.06
72351112|NCT01128426|144222697|SUPERIORITY_OR_OTHER|||||||0.52|||||||mid-p exact binomial method|||Asthma with acute exacerbation: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.52
72351113|NCT01128426|144222697|SUPERIORITY_OR_OTHER|||||||0.19|||||||mid-p exact binomial method|||Asthma, unspecified, unspecified status: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.19
72351114|NCT01128426|144222697|SUPERIORITY_OR_OTHER|||||||0.18|||||||mid-p exact binomial method|||Bronchiolitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.18
72351115|NCT01128426|144222697|SUPERIORITY_OR_OTHER|||||||0.68|||||||mid-p exact binomial method|||Bronchitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.68
72351116|NCT01128426|144222697|SUPERIORITY_OR_OTHER|||||||0.35|||||||mid-p exact binomial method|||Bronchospasm: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.35
72351117|NCT01128426|144222697|SUPERIORITY_OR_OTHER|||||||0.05|||||||mid-p exact binomial method|||Candidiasis of mouth: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.05
72351118|NCT01128426|144222697|SUPERIORITY_OR_OTHER|||||||0.42|||||||mid-p exact binomial method|||Cellulitis and abscess of trunk: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.42
72351119|NCT01128426|144222697|SUPERIORITY_OR_OTHER|||||||0.29|||||||mid-p exact binomial method|||Constipation: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.29
72351120|NCT01128426|144222697|SUPERIORITY_OR_OTHER|||||||0.11|||||||mid-p exact binomial method|||Croup: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.11
72351121|NCT01128426|144222697|SUPERIORITY_OR_OTHER|||||||1|||||||mid-p exact binomial method|||Dehydration: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||1.00
72351122|NCT01128426|144222697|SUPERIORITY_OR_OTHER||||||<|0.01|||||||mid-p exact binomial method|||Dermatitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||<0.01
72351123|NCT01128426|144222697|SUPERIORITY_OR_OTHER|||||||0.16|||||||mid-p exact binomial method|||Dyspnea: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.16
72351124|NCT01128426|144222697|SUPERIORITY_OR_OTHER|||||||0.19|||||||mid-p exact binomial method|||Failure to thrive: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.19
72351125|NCT01128426|144222697|SUPERIORITY_OR_OTHER||||||<|0.01|||||||mid-p exact binomial method|||Fever: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||<0.01
72351126|NCT01128426|144222697|SUPERIORITY_OR_OTHER|||||||0.4|||||||mid-p exact binomial method|||Fussy infant: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.40
72351127|NCT01128426|144222697|SUPERIORITY_OR_OTHER|||||||0.33|||||||mid-p exact binomial method|||Gastroenteritis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.33
72351128|NCT01128426|144222697|SUPERIORITY_OR_OTHER|||||||0.48|||||||mid-p exact binomial method|||Hand, foot and mouth disease: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.48
72351129|NCT01128426|144222697|SUPERIORITY_OR_OTHER|||||||0.95|||||||mid-p exact binomial method|||Hematoma: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.95
72351130|NCT01128426|144222697|SUPERIORITY_OR_OTHER|||||||0.27|||||||mid-p exact binomial method|||Hypopotassemia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.27
72351131|NCT01128426|144222697|SUPERIORITY_OR_OTHER|||||||0.57|||||||mid-p exact binomial method|||Lipoma of other specified sites: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.57
72351132|NCT01128426|144222697|SUPERIORITY_OR_OTHER|||||||0.15|||||||mid-p exact binomial method|||Methicillin susceptible Staphylococcus aureus: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.15
72351133|NCT01128426|144222697|SUPERIORITY_OR_OTHER|||||||0.14|||||||mid-p exact binomial method|||Nausea and vomiting: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.14
72351134|NCT01128426|144222697|SUPERIORITY_OR_OTHER|||||||0.08|||||||mid-p exact binomial method|||Neonatal bradycardia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.08
72351135|NCT01128426|144222697|SUPERIORITY_OR_OTHER|||||||0.68|||||||mid-p exact binomial method|||Neonatal candida infection: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.68
72351136|NCT01128426|144222697|SUPERIORITY_OR_OTHER|||||||0.15|||||||mid-p exact binomial method|||Other diseases of nasal cavity and sinuses: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.15
72351137|NCT01128426|144222697|SUPERIORITY_OR_OTHER|||||||0.14|||||||mid-p exact binomial method|||Other specified cardiac dysrhythmias: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.14
72351138|NCT01128426|144222697|SUPERIORITY_OR_OTHER||||||<|0.01|||||||mid-p exact binomial method|||Pilonidal cyst without mention of abscess: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||<0.01
72351139|NCT01128426|144222697|SUPERIORITY_OR_OTHER|||||||0.06|||||||mid-p exact binomial method|||Pneumonia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.06
72351140|NCT01128426|144222697|SUPERIORITY_OR_OTHER|||||||0.04|||||||mid-p exact binomial method|||Primary apnea of newborn: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.04
72351141|NCT01128426|144222697|SUPERIORITY_OR_OTHER|||||||0.96|||||||mid-p exact binomial method|||Rash: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.96
72351142|NCT01128426|144222697|SUPERIORITY_OR_OTHER|||||||0.13|||||||mid-p exact binomial method|||Respiratory syncytial virus: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.13
72351143|NCT01128426|144222697|SUPERIORITY_OR_OTHER|||||||0.14|||||||mid-p exact binomial method|||Retinopathy of prematurity stage 2: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.14
72351144|NCT01128426|144222697|SUPERIORITY_OR_OTHER|||||||0.67|||||||mid-p exact binomial method|||Single seizure: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.67
72351145|NCT01128426|144222697|SUPERIORITY_OR_OTHER|||||||0.65|||||||mid-p exact binomial method|||Stridor: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.65
72351146|NCT01128426|144222697|SUPERIORITY_OR_OTHER|||||||0.27|||||||mid-p exact binomial method|||Subconjunctival hemorrhage: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.27
72351147|NCT01128426|144222697|SUPERIORITY_OR_OTHER|||||||0.1|||||||mid-p exact binomial method|||Umbilical hernia without obstruction/gangrene: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.10
72351148|NCT01128426|144222697|SUPERIORITY_OR_OTHER|||||||0.08|||||||mid-p exact binomial method|||Unspecified bacterial pneumonia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.08
72351149|NCT01128426|144222697|SUPERIORITY_OR_OTHER|||||||0.08|||||||mid-p exact binomial method|||Unspecified septicemia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.08
72351150|NCT01128426|144222697|SUPERIORITY_OR_OTHER||||||<|0.01|||||||mid-p exact binomial method|||Urinary tract infection: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||<0.01
72351151|NCT01128426|144222697|SUPERIORITY_OR_OTHER|||||||0.91|||||||mid-p exact binomial method|||Urticaria: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.91
72351152|NCT01128426|144222697|SUPERIORITY_OR_OTHER|||||||0.14|||||||mid-p exact binomial method|||Vaccines adverse reaction: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.14
72351153|NCT01128426|144222697|SUPERIORITY_OR_OTHER|||||||0.05|||||||mid-p exact binomial method|||Viral syndrome: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.05
72351154|NCT01128426|144222697|SUPERIORITY_OR_OTHER|||||||0.27|||||||mid-p exact binomial method|||Weakness: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.27
72351155|NCT01128426|144222697|SUPERIORITY_OR_OTHER|||||||0.25|||||||mid-p exact binomial method|||Wheezing: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.25
72351156|NCT01128426|144222698|SUPERIORITY_OR_OTHER|||||||0.15|||||||mid-p exact binomial method|||Abnormal involuntary movements: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.15
72351157|NCT01128426|144222698|SUPERIORITY_OR_OTHER|||||||0.87|||||||mid-p exact binomial method|||Acute bronchiolitis due to RSV: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.87
72351158|NCT01128426|144222698|SUPERIORITY_OR_OTHER|||||||0.96|||||||mid-p exact binomial method|||Acute febrile mucocutaneous lymph node syndrome: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.96
72351159|NCT01128426|144222698|SUPERIORITY_OR_OTHER|||||||0.33|||||||mid-p exact binomial method|||Acute otitis media: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.33
72351160|NCT01128426|144222698|SUPERIORITY_OR_OTHER|||||||0.27|||||||mid-p exact binomial method|||Acute pyelonephritis without RMN lesion: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.27
72351161|NCT01128426|144222698|SUPERIORITY_OR_OTHER|||||||0.52|||||||mid-p exact binomial method|||Alkalosis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.52
72351162|NCT01128426|144222698|SUPERIORITY_OR_OTHER|||||||0.23|||||||mid-p exact binomial method|||Apnea: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.23
72351163|NCT01128426|144222698|SUPERIORITY_OR_OTHER|||||||0.19|||||||mid-p exact binomial method|||Apparent life threatening event infant: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.19
72351164|NCT01128426|144222698|SUPERIORITY_OR_OTHER|||||||0.96|||||||mid-p exact binomial method|||Asthma with acute exacerbation: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.96
72351165|NCT01128426|144222698|SUPERIORITY_OR_OTHER|||||||0.66|||||||mid-p exact binomial method|||Asthma, unspecified, unspecified status: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.66
72351166|NCT01128426|144222698|SUPERIORITY_OR_OTHER|||||||0.28|||||||mid-p exact binomial method|||Bronchiolitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.28
72351167|NCT01128426|144222698|SUPERIORITY_OR_OTHER|||||||0.96|||||||mid-p exact binomial method|||Bronchitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.96
72351168|NCT01128426|144222698|SUPERIORITY_OR_OTHER|||||||0.52|||||||mid-p exact binomial method|||Bronchospasm: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.52
72351169|NCT01128426|144222698|SUPERIORITY_OR_OTHER|||||||0.96|||||||mid-p exact binomial method|||Cellulitis and abscess of trunk: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.96
72351170|NCT01128426|144222698|SUPERIORITY_OR_OTHER|||||||0.41|||||||mid-p exact binomial method|||Constipation: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.41
72351171|NCT01128426|144222698|SUPERIORITY_OR_OTHER|||||||0.8|||||||mid-p exact binomial method|||Croup: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.80
72351172|NCT01128426|144222698|SUPERIORITY_OR_OTHER|||||||0.98|||||||mid-p exact binomial method|||Dehydration: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.98
72351173|NCT01128426|144222698|SUPERIORITY_OR_OTHER|||||||0.51|||||||mid-p exact binomial method|||Dermatitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.51
72351174|NCT01128426|144222698|SUPERIORITY_OR_OTHER|||||||0.92|||||||mid-p exact binomial method|||Dyspnea: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.92
72351175|NCT01128426|144222698|SUPERIORITY_OR_OTHER|||||||0.76|||||||mid-p exact binomial method|||Failure to thrive: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.76
72351176|NCT01128426|144222698|SUPERIORITY_OR_OTHER|||||||0.91|||||||mid-p exact binomial method|||Fever: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.91
72351177|NCT01128426|144222698|SUPERIORITY_OR_OTHER|||||||0.23|||||||mid-p exact binomial method|||Fussy infant: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.23
72351178|NCT01128426|144222698|SUPERIORITY_OR_OTHER|||||||0.95|||||||mid-p exact binomial method|||Gastroenteritis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.95
72351179|NCT01128426|144222698|SUPERIORITY_OR_OTHER|||||||0.52|||||||mid-p exact binomial method|||Hypopotassemia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.52
72351180|NCT01128426|144222698|SUPERIORITY_OR_OTHER|||||||0.27|||||||mid-p exact binomial method|||Lipoma of other specified sites: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.27
72351181|NCT01128426|144222698|SUPERIORITY_OR_OTHER|||||||0.14|||||||mid-p exact binomial method|||Methicillin susceptible Staphylococcus aureus: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.14
72351182|NCT01128426|144222698|SUPERIORITY_OR_OTHER|||||||0.48|||||||mid-p exact binomial method|||Nausea and vomiting: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.48
72351183|NCT01128426|144222698|SUPERIORITY_OR_OTHER|||||||0.34|||||||mid-p exact binomial method|||Other diseases of nasal cavity and sinuses: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.34
72351184|NCT01128426|144222698|SUPERIORITY_OR_OTHER|||||||0.41|||||||mid-p exact binomial method|||Other specified cardiac dysrhythmias: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.41
72351185|NCT01128426|144222698|SUPERIORITY_OR_OTHER|||||||0.07|||||||mid-p exact binomial method|||Pilonidal cyst without mention of abscess: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.07
72351186|NCT01128426|144222698|SUPERIORITY_OR_OTHER|||||||0.69|||||||mid-p exact binomial method|||Pneumonia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.69
72351187|NCT01128426|144222698|SUPERIORITY_OR_OTHER|||||||0.52|||||||mid-p exact binomial method|||Primary apnea of newborn: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.52
72351188|NCT01128426|144222698|SUPERIORITY_OR_OTHER|||||||0.48|||||||mid-p exact binomial method|||Rash: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.48
72351189|NCT01128426|144222698|SUPERIORITY_OR_OTHER|||||||0.52|||||||mid-p exact binomial method|||Retinopathy of prematurity stage 2: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.52
72351190|NCT01128426|144222698|SUPERIORITY_OR_OTHER|||||||0.4|||||||mid-p exact binomial method|||Single seizure: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.40
72351191|NCT01128426|144222698|SUPERIORITY_OR_OTHER|||||||0.25|||||||mid-p exact binomial method|||Stridor: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.25
72351192|NCT01128426|144222698|SUPERIORITY_OR_OTHER|||||||0.25|||||||mid-p exact binomial method|||Umbilical hernia without obstruction/gangrene: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.25
72351193|NCT01128426|144222698|SUPERIORITY_OR_OTHER|||||||0.96|||||||mid-p exact binomial method|||Unspecified bacterial pneumonia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.96
72351194|NCT01128426|144222698|SUPERIORITY_OR_OTHER|||||||0.96|||||||mid-p exact binomial method|||Unspecified septicemia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.96
72351195|NCT01128426|144222698|SUPERIORITY_OR_OTHER|||||||0.5|||||||mid-p exact binomial method|||Urinary tract infection: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.50
72351196|NCT01128426|144222698|SUPERIORITY_OR_OTHER|||||||0.48|||||||mid-p exact binomial method|||Urticaria: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.48
72351197|NCT01128426|144222698|SUPERIORITY_OR_OTHER|||||||0.8|||||||mid-p exact binomial method|||Viral syndrome: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.80
72351198|NCT01128426|144222698|SUPERIORITY_OR_OTHER|||||||0.52|||||||mid-p exact binomial method|||Weakness: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.52
72351199|NCT01128426|144222699|SUPERIORITY_OR_OTHER|||||||0.27|||||||mid-p exact binomial method|||Abnormal involuntary movements: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.27
72351200|NCT01128426|144222699|SUPERIORITY_OR_OTHER|||||||0.04|||||||mid-p exact binomial method|||Acute bronchiolitis due to RSV: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.04
72351201|NCT01128426|144222699|SUPERIORITY_OR_OTHER|||||||0.01|||||||mid-p exact binomial method|||Acute otitis media: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.01
72351202|NCT01128426|144222699|SUPERIORITY_OR_OTHER|||||||0.95|||||||mid-p exact binomial method|||Adverse drug reaction: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.95
72351203|NCT01128426|144222699|SUPERIORITY_OR_OTHER|||||||0.23|||||||mid-p exact binomial method|||Apnea: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.23
72351204|NCT01128426|144222699|SUPERIORITY_OR_OTHER|||||||0.34|||||||mid-p exact binomial method|||Apparent life threatening event infant: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.34
72351205|NCT01128426|144222699|SUPERIORITY_OR_OTHER|||||||0.48|||||||mid-p exact binomial method|||Asthma with acute exacerbation: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.48
72351206|NCT01128426|144222699|SUPERIORITY_OR_OTHER|||||||0.87|||||||mid-p exact binomial method|||Asthma, unspecified, unspecified status: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.87
72351207|NCT01128426|144222699|SUPERIORITY_OR_OTHER|||||||0.35|||||||mid-p exact binomial method|||Bronchiolitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.35
72351208|NCT01128426|144222699|SUPERIORITY_OR_OTHER|||||||0.84|||||||mid-p exact binomial method|||Bronchitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.84
72351209|NCT01128426|144222699|SUPERIORITY_OR_OTHER|||||||0.64|||||||mid-p exact binomial method|||Bronchospasm: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.64
72351210|NCT01128426|144222699|SUPERIORITY_OR_OTHER|||||||0.95|||||||mid-p exact binomial method|||Candidiasis of mouth: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.95
72351211|NCT01128426|144222699|SUPERIORITY_OR_OTHER|||||||0.41|||||||mid-p exact binomial method|||Constipation: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.41
72351212|NCT01128426|144222699|SUPERIORITY_OR_OTHER|||||||0.51|||||||mid-p exact binomial method|||Croup: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.51
72351213|NCT01128426|144222699|SUPERIORITY_OR_OTHER|||||||0.95|||||||mid-p exact binomial method|||Dehydration: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.95
72351214|NCT01128426|144222699|SUPERIORITY_OR_OTHER|||||||0.13|||||||mid-p exact binomial method|||Dermatitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.13
72351215|NCT01128426|144222699|SUPERIORITY_OR_OTHER|||||||0.7|||||||mid-p exact binomial method|||Dyspnea: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.70
72351216|NCT01128426|144222699|SUPERIORITY_OR_OTHER|||||||0.52|||||||mid-p exact binomial method|||Failure to thrive: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.52
72351217|NCT01128426|144222699|SUPERIORITY_OR_OTHER|||||||0.25|||||||mid-p exact binomial method|||Fever: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.25
72351218|NCT01128426|144222699|SUPERIORITY_OR_OTHER|||||||0.33|||||||mid-p exact binomial method|||Fussy infant: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.33
72351219|NCT01128426|144222699|SUPERIORITY_OR_OTHER|||||||0.9|||||||mid-p exact binomial method|||Gastroenteritis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.90
72351220|NCT01128426|144222699|SUPERIORITY_OR_OTHER|||||||0.67|||||||mid-p exact binomial method|||Hand, foot and mouth disease: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.67
72351221|NCT01128426|144222699|SUPERIORITY_OR_OTHER|||||||0.48|||||||mid-p exact binomial method|||Hematoma: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.48
72351222|NCT01128426|144222699|SUPERIORITY_OR_OTHER|||||||0.07|||||||mid-p exact binomial method|||Nausea and vomiting: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.07
72351223|NCT01128426|144222699|SUPERIORITY_OR_OTHER|||||||0.27|||||||mid-p exact binomial method|||Neonatal candida infection: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.27
72351224|NCT01128426|144222699|SUPERIORITY_OR_OTHER||||||<|0.01|||||||mid-p exact binomial method|||Other diseases of nasal cavity and sinuses: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||<0.01
72351225|NCT01128426|144222699|SUPERIORITY_OR_OTHER|||||||0.27|||||||mid-p exact binomial method|||Pneumonia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.27
72351226|NCT01128426|144222699|SUPERIORITY_OR_OTHER|||||||0.38|||||||mid-p exact binomial method|||Rash: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.38
72351227|NCT01128426|144222699|SUPERIORITY_OR_OTHER|||||||0.34|||||||mid-p exact binomial method|||Respiratory syncytial virus: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.34
72351228|NCT01128426|144222699|SUPERIORITY_OR_OTHER|||||||0.54|||||||mid-p exact binomial method|||Single seizure: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.54
72351229|NCT01128426|144222699|SUPERIORITY_OR_OTHER|||||||0.48|||||||mid-p exact binomial method|||Stomatitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.48
72351230|NCT01128426|144222699|SUPERIORITY_OR_OTHER|||||||0.52|||||||mid-p exact binomial method|||Stridor: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.52
72351231|NCT01128426|144222699|SUPERIORITY_OR_OTHER|||||||0.27|||||||mid-p exact binomial method|||Subconjunctival hemorrhage: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.27
72351232|NCT01128426|144222699|SUPERIORITY_OR_OTHER|||||||0.52|||||||mid-p exact binomial method|||Umbilical hernia without obstruction/gangrene: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.52
72351233|NCT01128426|144222699|SUPERIORITY_OR_OTHER|||||||0.48|||||||mid-p exact binomial method|||Unspecified septicemia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.48
72351234|NCT01128426|144222699|SUPERIORITY_OR_OTHER|||||||0.57|||||||mid-p exact binomial method|||Urinary tract infection: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.57
72351235|NCT01128426|144222699|SUPERIORITY_OR_OTHER|||||||0.7|||||||mid-p exact binomial method|||Urticaria: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.70
72351236|NCT01128426|144222699|SUPERIORITY_OR_OTHER|||||||0.52|||||||mid-p exact binomial method|||Vaccines adverse reaction: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.52
72351237|NCT01128426|144222699|SUPERIORITY_OR_OTHER|||||||0.03|||||||mid-p exact binomial method|||Viral syndrome: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.03
72351238|NCT01128426|144222699|SUPERIORITY_OR_OTHER|||||||0.52|||||||mid-p exact binomial method|||Weakness: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.52
72351239|NCT01128426|144222699|SUPERIORITY_OR_OTHER|||||||0.48|||||||mid-p exact binomial method|||Wheezing: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.48
72351240|NCT01128426|144222700|SUPERIORITY_OR_OTHER|||||||0.05|||||||mid-p exact binomial method|||Abnormal involuntary movements: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.05
72351241|NCT01128426|144222700|SUPERIORITY_OR_OTHER|||||||0.22|||||||mid-p exact binomial method|||Acute bronchiolitis due to RSV: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.22
72351242|NCT01128426|144222700|SUPERIORITY_OR_OTHER|||||||0.96|||||||mid-p exact binomial method|||Acute febrile mucocutaneous lymph node syndrome: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.96
72351243|NCT01128426|144222700|SUPERIORITY_OR_OTHER||||||<|0.01|||||||mid-p exact binomial method|||Acute otitis media: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||<0.01
72351244|NCT01128426|144222700|SUPERIORITY_OR_OTHER|||||||0.27|||||||mid-p exact binomial method|||Acute pyelonephritis without RMN lesion: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.27
72351245|NCT01128426|144222700|SUPERIORITY_OR_OTHER|||||||0.95|||||||mid-p exact binomial method|||Adverse drug reaction: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.95
72351246|NCT01128426|144222700|SUPERIORITY_OR_OTHER|||||||0.52|||||||mid-p exact binomial method|||Alkalosis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.52
72351247|NCT01128426|144222700|SUPERIORITY_OR_OTHER|||||||0.05|||||||mid-p exact binomial method|||Apnea: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.05
72351248|NCT01128426|144222700|SUPERIORITY_OR_OTHER|||||||0.15|||||||mid-p exact binomial method|||Apparent life threatening event infant: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.15
72351249|NCT01128426|144222700|SUPERIORITY_OR_OTHER|||||||0.58|||||||mid-p exact binomial method|||Asthma with acute exacerbation: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.58
72351250|NCT01128426|144222700|SUPERIORITY_OR_OTHER|||||||0.57|||||||mid-p exact binomial method|||Asthma, unspecified, unspecified status: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.57
72351251|NCT01128426|144222700|SUPERIORITY_OR_OTHER|||||||0.39|||||||mid-p exact binomial method|||Bronchiolitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.39
72351252|NCT01128426|144222700|SUPERIORITY_OR_OTHER|||||||0.87|||||||mid-p exact binomial method|||Bronchitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.87
72351253|NCT01128426|144222700|SUPERIORITY_OR_OTHER|||||||0.51|||||||mid-p exact binomial method|||Bronchospasm: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.51
72351254|NCT01128426|144222700|SUPERIORITY_OR_OTHER|||||||0.95|||||||mid-p exact binomial method|||Candidiasis of mouth: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.95
72351255|NCT01128426|144222700|SUPERIORITY_OR_OTHER|||||||0.96|||||||mid-p exact binomial method|||Cellulitis and abscess of trunk: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.96
72351256|NCT01128426|144222700|SUPERIORITY_OR_OTHER|||||||0.71|||||||mid-p exact binomial method|||Constipation: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.71
72351257|NCT01128426|144222700|SUPERIORITY_OR_OTHER|||||||0.51|||||||mid-p exact binomial method|||Croup: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.51
72351258|NCT01128426|144222700|SUPERIORITY_OR_OTHER|||||||0.48|||||||mid-p exact binomial method|||Dehydration: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.48
72351259|NCT01128426|144222700|SUPERIORITY_OR_OTHER|||||||0.32|||||||mid-p exact binomial method|||Dermatitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.32
72351260|NCT01128426|144222700|SUPERIORITY_OR_OTHER|||||||0.71|||||||mid-p exact binomial method|||Dyspnea: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.71
72351261|NCT01128426|144222700|SUPERIORITY_OR_OTHER|||||||0.76|||||||mid-p exact binomial method|||Failure to thrive: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.76
72351262|NCT01128426|144222700|SUPERIORITY_OR_OTHER|||||||0.29|||||||mid-p exact binomial method|||Fever: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.29
72351263|NCT01128426|144222700|SUPERIORITY_OR_OTHER|||||||0.58|||||||mid-p exact binomial method|||Fussy infant: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.58
72351264|NCT01128426|144222700|SUPERIORITY_OR_OTHER|||||||0.92|||||||mid-p exact binomial method|||Gastroenteritis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.92
72351265|NCT01128426|144222700|SUPERIORITY_OR_OTHER|||||||0.67|||||||mid-p exact binomial method|||Hand, foot and mouth disease: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.67
72351266|NCT01128426|144222700|SUPERIORITY_OR_OTHER|||||||0.48|||||||mid-p exact binomial method|||Hematoma: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.48
72351267|NCT01128426|144222700|SUPERIORITY_OR_OTHER|||||||0.52|||||||mid-p exact binomial method|||Hypopotassemia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.52
72351268|NCT01128426|144222700|SUPERIORITY_OR_OTHER|||||||0.27|||||||mid-p exact binomial method|||Lipoma of other specified sites: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.27
72351269|NCT01128426|144222700|SUPERIORITY_OR_OTHER|||||||0.14|||||||mid-p exact binomial method|||Methicillin susceptible Staphylococcus aureus: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.14
72351270|NCT01128426|144222700|SUPERIORITY_OR_OTHER|||||||0.07|||||||mid-p exact binomial method|||Nausea and vomiting: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.07
72351271|NCT01128426|144222700|SUPERIORITY_OR_OTHER|||||||0.27|||||||mid-p exact binomial method|||Neonatal candida infection: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.27
72351272|NCT01128426|144222700|SUPERIORITY_OR_OTHER|||||||0.04|||||||mid-p exact binomial method|||Other diseases of nasal cavity and sinuses: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.04
72351273|NCT01128426|144222700|SUPERIORITY_OR_OTHER|||||||0.41|||||||mid-p exact binomial method|||Other specified cardiac dysrhythmias: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.41
72351274|NCT01128426|144222700|SUPERIORITY_OR_OTHER|||||||0.07|||||||mid-p exact binomial method|||Pilonidal cyst without mention of abscess: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.07
72351275|NCT01128426|144222700|SUPERIORITY_OR_OTHER|||||||0.35|||||||mid-p exact binomial method|||Pneumonia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.35
72351276|NCT01128426|144222700|SUPERIORITY_OR_OTHER|||||||0.52|||||||mid-p exact binomial method|||Primary apnea of newborn: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.52
72351277|NCT01128426|144222700|SUPERIORITY_OR_OTHER|||||||0.3|||||||mid-p exact binomial method|||Rash: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.30
72351278|NCT01128426|144222700|SUPERIORITY_OR_OTHER|||||||0.34|||||||mid-p exact binomial method|||Respiratory syncytial virus: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.34
72351279|NCT01128426|144222700|SUPERIORITY_OR_OTHER|||||||0.52|||||||mid-p exact binomial method|||Retinopathy of prematurity stage 2: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.52
72351280|NCT01128426|144222700|SUPERIORITY_OR_OTHER|||||||0.7|||||||mid-p exact binomial method|||Single seizure: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.70
72351281|NCT01128426|144222700|SUPERIORITY_OR_OTHER|||||||0.48|||||||mid-p exact binomial method|||Stomatitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.48
72351282|NCT01128426|144222700|SUPERIORITY_OR_OTHER|||||||0.25|||||||mid-p exact binomial method|||Stridor: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.25
72351283|NCT01128426|144222700|SUPERIORITY_OR_OTHER|||||||0.27|||||||mid-p exact binomial method|||Subconjunctival hemorrhage: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.27
72351284|NCT01128426|144222700|SUPERIORITY_OR_OTHER|||||||0.15|||||||mid-p exact binomial method|||Umbilical hernia without obstruction/gangrene: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.15
72351285|NCT01128426|144222700|SUPERIORITY_OR_OTHER|||||||0.96|||||||mid-p exact binomial method|||Unspecified bacterial pneumonia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.96
72351286|NCT01128426|144222700|SUPERIORITY_OR_OTHER|||||||0.96|||||||mid-p exact binomial method|||Unspecified septicemia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.96
72351287|NCT01128426|144222700|SUPERIORITY_OR_OTHER|||||||0.76|||||||mid-p exact binomial method|||Urinary tract infection: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.76
72351288|NCT01128426|144222700|SUPERIORITY_OR_OTHER|||||||0.54|||||||mid-p exact binomial method|||Urticaria: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.54
72351289|NCT01128426|144222700|SUPERIORITY_OR_OTHER|||||||0.52|||||||mid-p exact binomial method|||Vaccines adverse reaction: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.52
72351290|NCT01128426|144222700|SUPERIORITY_OR_OTHER|||||||0.03|||||||mid-p exact binomial method|||Viral syndrome: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.03
72351291|NCT01128426|144222700|SUPERIORITY_OR_OTHER|||||||0.52|||||||mid-p exact binomial method|||Weakness: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.52
72351292|NCT01128426|144222700|SUPERIORITY_OR_OTHER|||||||0.48|||||||mid-p exact binomial method|||Wheezing: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.48
72351293|NCT01128426|144222701|SUPERIORITY_OR_OTHER|||||||0.63|||||||mid-p exact binomial method|||Abnormal involuntary movements: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0 .63
72351294|NCT01128426|144222701|SUPERIORITY_OR_OTHER|||||||0.73|||||||mid-p exact binomial method|||Acute bronchiolitis due to RSV: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.73
72351295|NCT01128426|144222701|SUPERIORITY_OR_OTHER|||||||0.03|||||||mid-p exact binomial method|||Acute febrile mucocutaneous lymph node syndrome: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.03
72351296|NCT01128426|144222701|SUPERIORITY_OR_OTHER|||||||0.6|||||||mid-p exact binomial method|||Acute otitis media: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.60
72351297|NCT01128426|144222701|SUPERIORITY_OR_OTHER|||||||0.38|||||||mid-p exact binomial method|||Acute pyelonephritis without RMN lesion: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.38
72351298|NCT01128426|144222701|SUPERIORITY_OR_OTHER|||||||0.5|||||||mid-p exact binomial method|||Alkalosis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.50
72351299|NCT01128426|144222701|SUPERIORITY_OR_OTHER|||||||0.99|||||||mid-p exact binomial method|||Apnea: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.99
72351300|NCT01128426|144222701|SUPERIORITY_OR_OTHER|||||||0.13|||||||mid-p exact binomial method|||Apparent life threatening event infant: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.13
72351301|NCT01128426|144222701|SUPERIORITY_OR_OTHER|||||||0.25|||||||mid-p exact binomial method|||Asthma with acute exacerbation: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.25
72351302|NCT01128426|144222701|SUPERIORITY_OR_OTHER|||||||0.11|||||||mid-p exact binomial method|||Asthma, unspecified, unspecified status: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.11
72351303|NCT01128426|144222701|SUPERIORITY_OR_OTHER|||||||0.53|||||||mid-p exact binomial method|||Bronchiolitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.53
72351304|NCT01128426|144222701|SUPERIORITY_OR_OTHER|||||||0.5|||||||mid-p exact binomial method|||Bronchitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.50
72351305|NCT01128426|144222701|SUPERIORITY_OR_OTHER|||||||0.63|||||||mid-p exact binomial method|||Candidiasis of mouth: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.63
72351306|NCT01128426|144222701|SUPERIORITY_OR_OTHER|||||||0.25|||||||mid-p exact binomial method|||Cellulitis and abscess of trunk: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.25
72351307|NCT01128426|144222701|SUPERIORITY_OR_OTHER|||||||0.53|||||||mid-p exact binomial method|||Constipation: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.53
72351308|NCT01128426|144222701|SUPERIORITY_OR_OTHER|||||||0.7|||||||mid-p exact binomial method|||Croup: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.70
72351309|NCT01128426|144222701|SUPERIORITY_OR_OTHER|||||||0.36|||||||mid-p exact binomial method|||Dehydration: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.36
72351310|NCT01128426|144222701|SUPERIORITY_OR_OTHER|||||||0.98|||||||mid-p exact binomial method|||Dermatitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.98
72351311|NCT01128426|144222701|SUPERIORITY_OR_OTHER|||||||0.04|||||||mid-p exact binomial method|||Dyspnea: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.04
72351312|NCT01128426|144222701|SUPERIORITY_OR_OTHER|||||||0.81|||||||mid-p exact binomial method|||Failure to thrive: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.81
72351313|NCT01128426|144222701|SUPERIORITY_OR_OTHER|||||||0.75|||||||mid-p exact binomial method|||Fever: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.75
72351314|NCT01128426|144222701|SUPERIORITY_OR_OTHER|||||||0.99|||||||mid-p exact binomial method|||Fussy infant: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.99
72351315|NCT01128426|144222701|SUPERIORITY_OR_OTHER|||||||0.13|||||||mid-p exact binomial method|||Gastroenteritis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.13
72351316|NCT01128426|144222701|SUPERIORITY_OR_OTHER|||||||0.5|||||||mid-p exact binomial method|||Hand, foot and mouth disease: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.50
72351317|NCT01128426|144222701|SUPERIORITY_OR_OTHER|||||||0.25|||||||mid-p exact binomial method|||Hypopotassemia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.25
72351318|NCT01128426|144222701|SUPERIORITY_OR_OTHER|||||||0.37|||||||mid-p exact binomial method|||Lipoma of other specified sites: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.37
72351319|NCT01128426|144222701|SUPERIORITY_OR_OTHER|||||||0.12|||||||mid-p exact binomial method|||Methicillin susceptible Staphylococcus aureus: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.12
72351320|NCT01128426|144222701|SUPERIORITY_OR_OTHER|||||||0.5|||||||mid-p exact binomial method|||Nausea and vomiting: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.50
72351321|NCT01128426|144222701|SUPERIORITY_OR_OTHER|||||||0.99|||||||mid-p exact binomial method|||Other diseases of nasal cavity and sinuses: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.99
72351322|NCT01128426|144222701|SUPERIORITY_OR_OTHER|||||||0.63|||||||mid-p exact binomial method|||Other specified cardiac dysrhythmias: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.63
72351323|NCT01128426|144222701|SUPERIORITY_OR_OTHER|||||||0.78|||||||mid-p exact binomial method|||Pilonidal cyst without mention of abscess: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.78
72351324|NCT01128426|144222701|SUPERIORITY_OR_OTHER|||||||0.84|||||||mid-p exact binomial method|||Pneumonia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.84
72351325|NCT01128426|144222701|SUPERIORITY_OR_OTHER|||||||0.44|||||||mid-p exact binomial method|||Rash: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.44
72351326|NCT01128426|144222701|SUPERIORITY_OR_OTHER|||||||0.5|||||||mid-p exact binomial method|||Respiratory syncytial virus: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.50
72351327|NCT01128426|144222701|SUPERIORITY_OR_OTHER|||||||0.41|||||||mid-p exact binomial method|||Single seizure: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.41
72351328|NCT01128426|144222701|SUPERIORITY_OR_OTHER|||||||0.99|||||||mid-p exact binomial method|||Stridor: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.99
72351329|NCT01128426|144222701|SUPERIORITY_OR_OTHER|||||||0.5|||||||mid-p exact binomial method|||Subconjunctival hemorrhage: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.50
72351330|NCT01128426|144222701|SUPERIORITY_OR_OTHER|||||||0.63|||||||mid-p exact binomial method|||Umbilical hernia without obstruction/gangrene: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.63
72351331|NCT01128426|144222701|SUPERIORITY_OR_OTHER|||||||0.99|||||||mid-p exact binomial method|||Unspecified bacterial pneumonia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.99
72351332|NCT01128426|144222701|SUPERIORITY_OR_OTHER|||||||0.5|||||||mid-p exact binomial method|||Unspecified septicemia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.50
72351333|NCT01128426|144222701|SUPERIORITY_OR_OTHER|||||||0.28|||||||mid-p exact binomial method|||Urinary tract infection: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.28
72351334|NCT01128426|144222701|SUPERIORITY_OR_OTHER|||||||0.21|||||||mid-p exact binomial method|||Viral syndrome: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.21
72351335|NCT01128426|144222701|SUPERIORITY_OR_OTHER|||||||0.98|||||||mid-p exact binomial method|||Wheezing: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.98
72351336|NCT01128426|144222702|SUPERIORITY_OR_OTHER|||||||0.5|||||||mid-p exact binomial method|||Abnormal involuntary movements: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.50
72351337|NCT01128426|144222702|SUPERIORITY_OR_OTHER|||||||0.77|||||||mid-p exact binomial method|||Acute bronchiolitis due to RSV: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.77
72351338|NCT01128426|144222702|SUPERIORITY_OR_OTHER|||||||0.5|||||||mid-p exact binomial method|||Acute febrile mucocutaneous lymph node syndrome: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.50
72351339|NCT01128426|144222702|SUPERIORITY_OR_OTHER|||||||0.55|||||||mid-p exact binomial method|||Acute otitis media: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.55
72351340|NCT01128426|144222702|SUPERIORITY_OR_OTHER|||||||0.5|||||||mid-p exact binomial method|||Acute pyelonephritis without RMN lesion: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.50
72351341|NCT01128426|144222702|SUPERIORITY_OR_OTHER|||||||0.62|||||||mid-p exact binomial method|||Adverse drug reaction: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.62
72351342|NCT01128426|144222702|SUPERIORITY_OR_OTHER|||||||0.5|||||||mid-p exact binomial method|||Apnea: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.50
72351343|NCT01128426|144222702|SUPERIORITY_OR_OTHER|||||||0.5|||||||mid-p exact binomial method|||Apparent life threatening event infant: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.50
72351344|NCT01128426|144222702|SUPERIORITY_OR_OTHER|||||||0.25|||||||mid-p exact binomial method|||Asthma with acute exacerbation: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.25
72351345|NCT01128426|144222702|SUPERIORITY_OR_OTHER|||||||0.43|||||||mid-p exact binomial method|||Asthma, unspecified, unspecified status: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.43
72351346|NCT01128426|144222702|SUPERIORITY_OR_OTHER|||||||0.22|||||||mid-p exact binomial method|||Bronchiolitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.22
72351347|NCT01128426|144222702|SUPERIORITY_OR_OTHER|||||||0.22|||||||mid-p exact binomial method|||Bronchitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.22
72351348|NCT01128426|144222702|SUPERIORITY_OR_OTHER|||||||0.14|||||||mid-p exact binomial method|||Bronchospasm: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.14
72351349|NCT01128426|144222702|SUPERIORITY_OR_OTHER|||||||0.21|||||||mid-p exact binomial method|||Candidiasis of mouth: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.21
72351350|NCT01128426|144222702|SUPERIORITY_OR_OTHER|||||||0.5|||||||mid-p exact binomial method|||Cellulitis and abscess of trunk: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.50
72351351|NCT01128426|144222702|SUPERIORITY_OR_OTHER|||||||0.85|||||||mid-p exact binomial method|||Constipation: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.85
72351352|NCT01128426|144222702|SUPERIORITY_OR_OTHER|||||||0.28|||||||mid-p exact binomial method|||Croup: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.28
72351353|NCT01128426|144222702|SUPERIORITY_OR_OTHER|||||||0.7|||||||mid-p exact binomial method|||Dehydration: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.70
72351354|NCT01128426|144222702|SUPERIORITY_OR_OTHER|||||||0.28|||||||mid-p exact binomial method|||Dermatitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.28
72351355|NCT01128426|144222702|SUPERIORITY_OR_OTHER|||||||0.15|||||||mid-p exact binomial method|||Dyspnea: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.15
72351356|NCT01128426|144222702|SUPERIORITY_OR_OTHER|||||||0.99|||||||mid-p exact binomial method|||Failure to thrive: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.99
72351357|NCT01128426|144222702|SUPERIORITY_OR_OTHER|||||||0.51|||||||mid-p exact binomial method|||Fever: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.51
72351358|NCT01128426|144222702|SUPERIORITY_OR_OTHER|||||||0.67|||||||mid-p exact binomial method|||Fussy infant: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.67
72351359|NCT01128426|144222702|SUPERIORITY_OR_OTHER|||||||0.06|||||||mid-p exact binomial method|||Gastroenteritis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.06
72351360|NCT01128426|144222702|SUPERIORITY_OR_OTHER|||||||0.74|||||||mid-p exact binomial method|||Hand, foot and mouth disease: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.74
72351361|NCT01128426|144222702|SUPERIORITY_OR_OTHER|||||||0.99|||||||mid-p exact binomial method|||Hematoma: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.99
72351362|NCT01128426|144222702|SUPERIORITY_OR_OTHER|||||||0.5|||||||mid-p exact binomial method|||Nausea and vomiting: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.50
72351363|NCT01128426|144222702|SUPERIORITY_OR_OTHER|||||||0.25|||||||mid-p exact binomial method|||Neonatal candida infection: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.25
72351364|NCT01128426|144222702|SUPERIORITY_OR_OTHER|||||||0.82|||||||mid-p exact binomial method|||Other diseases of nasal cavity and sinuses: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.82
72351365|NCT01128426|144222702|SUPERIORITY_OR_OTHER|||||||0.25|||||||mid-p exact binomial method|||Other specified cardiac dysrhythmias: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.25
72351366|NCT01128426|144222702|SUPERIORITY_OR_OTHER|||||||0.55|||||||mid-p exact binomial method|||Pneumonia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.55
72351367|NCT01128426|144222702|SUPERIORITY_OR_OTHER|||||||0.26|||||||mid-p exact binomial method|||Rash: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.26
72351368|NCT01128426|144222702|SUPERIORITY_OR_OTHER|||||||0.33|||||||mid-p exact binomial method|||Respiratory syncytial virus: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.33
72351369|NCT01128426|144222702|SUPERIORITY_OR_OTHER|||||||0.81|||||||mid-p exact binomial method|||Single seizure: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.81
72351370|NCT01128426|144222702|SUPERIORITY_OR_OTHER|||||||0.5|||||||mid-p exact binomial method|||Stomatitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.50
72351371|NCT01128426|144222702|SUPERIORITY_OR_OTHER|||||||0.06|||||||mid-p exact binomial method|||Stridor: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.06
72351372|NCT01128426|144222702|SUPERIORITY_OR_OTHER|||||||0.5|||||||mid-p exact binomial method|||Umbilical hernia without obstruction/gangrene: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.50
72351373|NCT01128426|144222702|SUPERIORITY_OR_OTHER|||||||0.25|||||||mid-p exact binomial method|||Unspecified septicemia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.25
72351374|NCT01128426|144222702|SUPERIORITY_OR_OTHER|||||||0.64|||||||mid-p exact binomial method|||Urinary tract infection: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.64
72351375|NCT01128426|144222702|SUPERIORITY_OR_OTHER|||||||0.97|||||||mid-p exact binomial method|||Urticaria: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.97
72351376|NCT01128426|144222702|SUPERIORITY_OR_OTHER|||||||0.31|||||||mid-p exact binomial method|||Viral syndrome: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.31
72351377|NCT01128426|144222702|SUPERIORITY_OR_OTHER|||||||0.25|||||||mid-p exact binomial method|||Weakness: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.25
72351378|NCT01128426|144222702|SUPERIORITY_OR_OTHER|||||||0.03|||||||mid-p exact binomial method|||Wheezing: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.03
72351379|NCT01128426|144222703|SUPERIORITY_OR_OTHER|||||||0.38|||||||mid-p exact binomial method|||Abnormal involuntary movements: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.38
72351380|NCT01128426|144222703|SUPERIORITY_OR_OTHER|||||||0.78|||||||mid-p exact binomial method|||Acute bronchiolitis due to RSV: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.78
72351381|NCT01128426|144222703|SUPERIORITY_OR_OTHER|||||||0.13|||||||mid-p exact binomial method|||Acute febrile mucocutaneous lymph node syndrome: p-value was estimated using the mid-p exact binomial method.The null hypothesis was relative risk = 1.||||0.13
72351382|NCT01128426|144222703|SUPERIORITY_OR_OTHER|||||||0.73|||||||mid-p exact binomial method|||Acute otitis media: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.73
72351383|NCT01128426|144222703|SUPERIORITY_OR_OTHER|||||||0.23|||||||mid-p exact binomial method|||Acute pyelonephritis without RMN lesion: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.23
72351384|NCT01128426|144222703|SUPERIORITY_OR_OTHER|||||||0.62|||||||mid-p exact binomial method|||Adverse drug reaction: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.62
72351385|NCT01128426|144222703|SUPERIORITY_OR_OTHER|||||||0.5|||||||mid-p exact binomial method|||Alkalosis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.50
72351386|NCT01128426|144222703|SUPERIORITY_OR_OTHER|||||||0.99|||||||mid-p exact binomial method|||Apnea: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.99
72351387|NCT01128426|144222703|SUPERIORITY_OR_OTHER|||||||0.13|||||||mid-p exact binomial method|||Apparent life threatening event infant: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.13
72351388|NCT01128426|144222703|SUPERIORITY_OR_OTHER|||||||0.06|||||||mid-p exact binomial method|||Asthma with acute exacerbation: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.06
72351389|NCT01128426|144222703|SUPERIORITY_OR_OTHER|||||||0.15|||||||mid-p exact binomial method|||Asthma, unspecified, unspecified status: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.15
72351390|NCT01128426|144222703|SUPERIORITY_OR_OTHER|||||||0.14|||||||mid-p exact binomial method|||Bronchiolitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.14
72351391|NCT01128426|144222703|SUPERIORITY_OR_OTHER|||||||0.14|||||||mid-p exact binomial method|||Bronchitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.14
72351392|NCT01128426|144222703|SUPERIORITY_OR_OTHER|||||||0.14|||||||mid-p exact binomial method|||Bronchospasm: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.14
72351393|NCT01128426|144222703|SUPERIORITY_OR_OTHER|||||||0.28|||||||mid-p exact binomial method|||Candidiasis of mouth: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.28
72351394|NCT01128426|144222703|SUPERIORITY_OR_OTHER|||||||0.12|||||||mid-p exact binomial method|||Cellulitis and abscess of trunk: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.12
72351395|NCT01128426|144222703|SUPERIORITY_OR_OTHER|||||||0.68|||||||mid-p exact binomial method|||Constipation: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.68
72351396|NCT01128426|144222703|SUPERIORITY_OR_OTHER|||||||0.24|||||||mid-p exact binomial method|||Croup: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.24
72351397|NCT01128426|144222703|SUPERIORITY_OR_OTHER|||||||0.61|||||||mid-p exact binomial method|||Dehydration: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.61
72351398|NCT01128426|144222703|SUPERIORITY_OR_OTHER|||||||0.28|||||||mid-p exact binomial method|||Dermatitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.28
72351399|NCT01128426|144222703|SUPERIORITY_OR_OTHER|||||||0.62|||||||mid-p exact binomial method|||Dyspnea: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.62
72351400|NCT01128426|144222703|SUPERIORITY_OR_OTHER|||||||0.63|||||||mid-p exact binomial method|||Failure to thrive: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.63
72351401|NCT01128426|144222703|SUPERIORITY_OR_OTHER|||||||0.66|||||||mid-p exact binomial method|||Fever: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.66
72351402|NCT01128426|144222703|SUPERIORITY_OR_OTHER|||||||0.68|||||||mid-p exact binomial method|||Fussy infant: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.68
72351403|NCT01128426|144222703|SUPERIORITY_OR_OTHER|||||||0.18|||||||mid-p exact binomial method|||Gastroenteritis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.18
72351404|NCT01128426|144222703|SUPERIORITY_OR_OTHER|||||||0.52|||||||mid-p exact binomial method|||Hand, foot and mouth disease: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.52
72351405|NCT01128426|144222703|SUPERIORITY_OR_OTHER|||||||0.99|||||||mid-p exact binomial method|||Hematoma: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.99
72351406|NCT01128426|144222703|SUPERIORITY_OR_OTHER|||||||0.25|||||||mid-p exact binomial method|||Hypopotassemia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.25
72351407|NCT01128426|144222703|SUPERIORITY_OR_OTHER|||||||0.37|||||||mid-p exact binomial method|||Lipoma of other specified sites: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.37
72351408|NCT01128426|144222703|SUPERIORITY_OR_OTHER|||||||0.12|||||||mid-p exact binomial method|||Methicillin susceptible Staphylococcus aureus: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.12
72351409|NCT01128426|144222703|SUPERIORITY_OR_OTHER|||||||0.5|||||||mid-p exact binomial method|||Nausea and vomiting: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.50
72351410|NCT01128426|144222703|SUPERIORITY_OR_OTHER|||||||0.25|||||||mid-p exact binomial method|||Neonatal candida infection: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.25
72351411|NCT01128426|144222703|SUPERIORITY_OR_OTHER|||||||0.82|||||||mid-p exact binomial method|||Other diseases of nasal cavity and sinuses: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.82
72351412|NCT01128426|144222703|SUPERIORITY_OR_OTHER|||||||0.38|||||||mid-p exact binomial method|||Other specified cardiac dysrhythmias: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.38
72351413|NCT01128426|144222703|SUPERIORITY_OR_OTHER|||||||0.78|||||||mid-p exact binomial method|||Pilonidal cyst without mention of abscess: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.78
72351414|NCT01128426|144222703|SUPERIORITY_OR_OTHER|||||||0.65|||||||mid-p exact binomial method|||Pneumonia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.65
72351415|NCT01128426|144222703|SUPERIORITY_OR_OTHER|||||||0.17|||||||mid-p exact binomial method|||Rash: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.17
72351416|NCT01128426|144222703|SUPERIORITY_OR_OTHER|||||||0.22|||||||mid-p exact binomial method|||Respiratory syncytial virus: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.22
72351417|NCT01128426|144222703|SUPERIORITY_OR_OTHER|||||||0.81|||||||mid-p exact binomial method|||Single seizure: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.81
72351418|NCT01128426|144222703|SUPERIORITY_OR_OTHER|||||||0.5|||||||mid-p exact binomial method|||Stomatitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.50
72351419|NCT01128426|144222703|SUPERIORITY_OR_OTHER|||||||0.13|||||||mid-p exact binomial method|||Stridor: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.13
72351420|NCT01128426|144222703|SUPERIORITY_OR_OTHER|||||||0.5|||||||mid-p exact binomial method|||Subconjunctival hemorrhage: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.50
72351421|NCT01128426|144222703|SUPERIORITY_OR_OTHER|||||||0.99|||||||mid-p exact binomial method|||Umbilical hernia without obstruction/gangrene: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.99
72351422|NCT01128426|144222703|SUPERIORITY_OR_OTHER|||||||0.99|||||||mid-p exact binomial method|||Unspecified bacterial pneumonia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.99
72351423|NCT01128426|144222703|SUPERIORITY_OR_OTHER|||||||0.25|||||||mid-p exact binomial method|||Unspecified septicemia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.25
72351424|NCT01128426|144222703|SUPERIORITY_OR_OTHER|||||||0.96|||||||mid-p exact binomial method|||Urinary tract infection: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.96
72351425|NCT01128426|144222703|SUPERIORITY_OR_OTHER|||||||0.97|||||||mid-p exact binomial method|||Urticaria: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.97
72351426|NCT01128426|144222703|SUPERIORITY_OR_OTHER|||||||0.19|||||||mid-p exact binomial method|||Viral syndrome: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.19
72351427|NCT01128426|144222703|SUPERIORITY_OR_OTHER|||||||0.25|||||||mid-p exact binomial method|||Weakness: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.25
72351428|NCT01128426|144222703|SUPERIORITY_OR_OTHER|||||||0.03|||||||mid-p exact binomial method|||Wheezing: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.03
72351429|NCT01128426|144222704|SUPERIORITY_OR_OTHER|||||||0.03|||||||mid-p exact binomial method|||Abnormal involuntary movements: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.03
72351430|NCT01128426|144222704|SUPERIORITY_OR_OTHER|||||||0.03|||||||mid-p exact binomial method|||Acute bronchiolitis due to RSV: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.03
72351431|NCT01128426|144222704|SUPERIORITY_OR_OTHER|||||||0.13|||||||mid-p exact binomial method|||Acute febrile mucocutaneous lymph node syndrome: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.13
72351432|NCT01128426|144222704|SUPERIORITY_OR_OTHER|||||||0.73|||||||mid-p exact binomial method|||Acute otitis media: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.73
72351433|NCT01128426|144222704|SUPERIORITY_OR_OTHER|||||||0.26|||||||mid-p exact binomial method|||Acute pyelonephritis without RMN lesion: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.26
72351434|NCT01128426|144222704|SUPERIORITY_OR_OTHER|||||||0.05|||||||mid-p exact binomial method|||Alkalosis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.05
72351435|NCT01128426|144222704|SUPERIORITY_OR_OTHER|||||||0.4|||||||mid-p exact binomial method|||Apnea: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.40
72351436|NCT01128426|144222704|SUPERIORITY_OR_OTHER|||||||0.2|||||||mid-p exact binomial method|||Apparent life threatening event infant: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.20
72351437|NCT01128426|144222704|SUPERIORITY_OR_OTHER|||||||0.41|||||||mid-p exact binomial method|||Asthma with acute exacerbation: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.41
72351438|NCT01128426|144222704|SUPERIORITY_OR_OTHER|||||||0.59|||||||mid-p exact binomial method|||Asthma, unspecified, unspecified status: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.59
72351439|NCT01128426|144222704|SUPERIORITY_OR_OTHER|||||||0.1|||||||mid-p exact binomial method|||Bronchiolitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.10
72351440|NCT01128426|144222704|SUPERIORITY_OR_OTHER|||||||0.95|||||||mid-p exact binomial method|||Bronchitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.95
72351441|NCT01128426|144222704|SUPERIORITY_OR_OTHER|||||||0.52|||||||mid-p exact binomial method|||Bronchospasm: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.52
72351442|NCT01128426|144222704|SUPERIORITY_OR_OTHER|||||||0.05|||||||mid-p exact binomial method|||Candidiasis of mouth: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.05
72351443|NCT01128426|144222704|SUPERIORITY_OR_OTHER|||||||0.93|||||||mid-p exact binomial method|||Cellulitis and abscess of trunk: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.93
72351444|NCT01128426|144222704|SUPERIORITY_OR_OTHER|||||||0.56|||||||mid-p exact binomial method|||Constipation: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.56
72351445|NCT01128426|144222704|SUPERIORITY_OR_OTHER|||||||0.79|||||||mid-p exact binomial method|||Croup: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.79
72351446|NCT01128426|144222704|SUPERIORITY_OR_OTHER|||||||0.46|||||||mid-p exact binomial method|||Dehydration: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.46
72351447|NCT01128426|144222704|SUPERIORITY_OR_OTHER|||||||0.92|||||||mid-p exact binomial method|||Dermatitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.92
72351448|NCT01128426|144222704|SUPERIORITY_OR_OTHER|||||||0.73|||||||mid-p exact binomial method|||Dyspnea: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.73
72351449|NCT01128426|144222704|SUPERIORITY_OR_OTHER|||||||0.27|||||||mid-p exact binomial method|||Failure to thrive: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.27
72351450|NCT01128426|144222704|SUPERIORITY_OR_OTHER|||||||0.4|||||||mid-p exact binomial method|||Fever: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.40
72351451|NCT01128426|144222704|SUPERIORITY_OR_OTHER|||||||0.93|||||||mid-p exact binomial method|||Fussy infant: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.93
72351452|NCT01128426|144222704|SUPERIORITY_OR_OTHER|||||||0.82|||||||mid-p exact binomial method|||Gastroenteritis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.82
72351453|NCT01128426|144222704|SUPERIORITY_OR_OTHER|||||||0.52|||||||mid-p exact binomial method|||Hand, foot and mouth disease: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.52
72351454|NCT01128426|144222704|SUPERIORITY_OR_OTHER|||||||0.04|||||||mid-p exact binomial method|||Hypopotassemia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.04
72351455|NCT01128426|144222704|SUPERIORITY_OR_OTHER|||||||0.69|||||||mid-p exact binomial method|||Lipoma of other specified sites: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.69
72351456|NCT01128426|144222704|SUPERIORITY_OR_OTHER|||||||0.53|||||||mid-p exact binomial method|||Methicillin susceptible Staphylococcus aureus: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.53
72351457|NCT01128426|144222704|SUPERIORITY_OR_OTHER|||||||0.59|||||||mid-p exact binomial method|||Nausea and vomiting: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.59
72351458|NCT01128426|144222704|SUPERIORITY_OR_OTHER|||||||0.07|||||||mid-p exact binomial method|||Neonatal bradycardia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.07
72351459|NCT01128426|144222704|SUPERIORITY_OR_OTHER|||||||0.27|||||||mid-p exact binomial method|||Other diseases of nasal cavity and sinuses: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.27
72351460|NCT01128426|144222704|SUPERIORITY_OR_OTHER|||||||0.06|||||||mid-p exact binomial method|||Other specified cardiac dysrhythmias: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.06
72351461|NCT01128426|144222704|SUPERIORITY_OR_OTHER||||||<|0.01|||||||mid-p exact binomial method|||Pilonidal cyst without mention of abscess: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||<0.01
72351462|NCT01128426|144222704|SUPERIORITY_OR_OTHER|||||||0.85|||||||mid-p exact binomial method|||Pneumonia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.85
72351463|NCT01128426|144222704|SUPERIORITY_OR_OTHER|||||||0.02|||||||mid-p exact binomial method|||Primary apnea of newborn: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.02
72351464|NCT01128426|144222704|SUPERIORITY_OR_OTHER|||||||0.33|||||||mid-p exact binomial method]|||Rash: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.33
72351465|NCT01128426|144222704|SUPERIORITY_OR_OTHER|||||||0.59|||||||mid-p exact binomial method|||Respiratory syncytial virus: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.59
72351466|NCT01128426|144222704|SUPERIORITY_OR_OTHER|||||||0.07|||||||mid-p exact binomial method|||Retinopathy of prematurity stage 2: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.07
72351467|NCT01128426|144222704|SUPERIORITY_OR_OTHER|||||||0.14|||||||mid-p exact binomial method|||Single seizure: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.14
72351468|NCT01128426|144222704|SUPERIORITY_OR_OTHER|||||||0.53|||||||mid-p exact binomial method|||Stridor: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.53
72351469|NCT01128426|144222704|SUPERIORITY_OR_OTHER|||||||0.48|||||||mid-p exact binomial method|||Subconjunctival hemorrhage: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.48
72351470|NCT01128426|144222704|SUPERIORITY_OR_OTHER|||||||0.03|||||||mid-p exact binomial method|||Umbilical hernia without obstruction/gangrene: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.03
72351471|NCT01128426|144222704|SUPERIORITY_OR_OTHER|||||||0.21|||||||mid-p exact binomial method|||Unspecified bacterial pneumonia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.21
72351472|NCT01128426|144222704|SUPERIORITY_OR_OTHER|||||||0.27|||||||mid-p exact binomial method|||Unspecified septicemia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.27
72351473|NCT01128426|144222704|SUPERIORITY_OR_OTHER|||||||0.73|||||||mid-p exact binomial method|||Urinary tract infection: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.73
72351474|NCT01128426|144222704|SUPERIORITY_OR_OTHER|||||||0.48|||||||mid-p exact binomial method|||Urticaria: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.48
72351475|NCT01128426|144222704|SUPERIORITY_OR_OTHER|||||||0.73|||||||mid-p exact binomial method|||Viral syndrome: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.73
72351476|NCT01128426|144222704|SUPERIORITY_OR_OTHER|||||||0.14|||||||mid-p exact binomial method|||Weakness: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.14
72351477|NCT01128426|144222704|SUPERIORITY_OR_OTHER|||||||0.94|||||||mid-p exact binomial method|||Wheezing: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.94
72351478|NCT01128426|144222705|SUPERIORITY_OR_OTHER|||||||0.56|||||||mid-p exact binomial method|||Abnormal involuntary movements: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.56
72351479|NCT01128426|144222705|SUPERIORITY_OR_OTHER|||||||0.43|||||||mid-p exact binomial method|||Acute bronchiolitis due to RSV: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.43
72351480|NCT01128426|144222705|SUPERIORITY_OR_OTHER|||||||0.48|||||||mid-p exact binomial method|||Acute febrile mucocutaneous lymph node syndrome: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.48
72351481|NCT01128426|144222705|SUPERIORITY_OR_OTHER|||||||0.01|||||||mid-p exact binomial method|||Acute otitis media: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.01
72351482|NCT01128426|144222705|SUPERIORITY_OR_OTHER|||||||0.52|||||||mid-p exact binomial method|||Acute pyelonephritis without RMN lesion: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.52
72351483|NCT01128426|144222705|SUPERIORITY_OR_OTHER|||||||0.93|||||||mid-p exact binomial method|||Adverse drug reaction: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.93
72351484|NCT01128426|144222705|SUPERIORITY_OR_OTHER|||||||0.52|||||||mid-p exact binomial method|||Alkalosis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.52
72351485|NCT01128426|144222705|SUPERIORITY_OR_OTHER|||||||0.32|||||||mid-p exact binomial method|||Apnea: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.32
72351486|NCT01128426|144222705|SUPERIORITY_OR_OTHER|||||||0.24|||||||mid-p exact binomial method|||Apparent life threatening event infant: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.24
72351487|NCT01128426|144222705|SUPERIORITY_OR_OTHER|||||||0.41|||||||mid-p exact binomial method|||Asthma with acute exacerbation: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.41
72351488|NCT01128426|144222705|SUPERIORITY_OR_OTHER|||||||0.06|||||||mid-p exact binomial method|||Asthma, unspecified, unspecified status: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.06
72351489|NCT01128426|144222705|SUPERIORITY_OR_OTHER|||||||0.31|||||||mid-p exact binomial method|||Bronchiolitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.31
72351490|NCT01128426|144222705|SUPERIORITY_OR_OTHER|||||||0.43|||||||mid-p exact binomial method|||Bronchitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.43
72351491|NCT01128426|144222705|SUPERIORITY_OR_OTHER|||||||0.5|||||||mid-p exact binomial method|||Bronchospasm: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.50
72351492|NCT01128426|144222705|SUPERIORITY_OR_OTHER|||||||0.51|||||||mid-p exact binomial method|||Candidiasis of mouth: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.51
72351493|NCT01128426|144222705|SUPERIORITY_OR_OTHER|||||||0.48|||||||mid-p exact binomial method|||Cellulitis and abscess of trunk: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.48
72351494|NCT01128426|144222705|SUPERIORITY_OR_OTHER|||||||0.44|||||||mid-p exact binomial method|||Constipation: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.44
72351495|NCT01128426|144222705|SUPERIORITY_OR_OTHER|||||||0.7|||||||mid-p exact binomial method|||Croup: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.70
72351496|NCT01128426|144222705|SUPERIORITY_OR_OTHER|||||||0.87|||||||mid-p exact binomial method|||Dehydration: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.87
72351497|NCT01128426|144222705|SUPERIORITY_OR_OTHER|||||||0.05|||||||mid-p exact binomial method|||Dermatitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.05
72351498|NCT01128426|144222705|SUPERIORITY_OR_OTHER|||||||0.24|||||||mid-p exact binomial method|||Dyspnea: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.24
72351499|NCT01128426|144222705|SUPERIORITY_OR_OTHER|||||||0.24|||||||mid-p exact binomial method|||Failure to thrive: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.24
72351500|NCT01128426|144222705|SUPERIORITY_OR_OTHER|||||||0.03|||||||mid-p exact binomial method|||Fever: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.03
72351501|NCT01128426|144222705|SUPERIORITY_OR_OTHER|||||||0.37|||||||mid-p exact binomial method|||Fussy infant: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.37
72351502|NCT01128426|144222705|SUPERIORITY_OR_OTHER|||||||0.16|||||||mid-p exact binomial method|||Gastroenteritis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.16
72351503|NCT01128426|144222705|SUPERIORITY_OR_OTHER|||||||0.85|||||||mid-p exact binomial method|||Hand, foot and mouth disease: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.85
72351504|NCT01128426|144222705|SUPERIORITY_OR_OTHER|||||||0.67|||||||mid-p exact binomial method|||Hematoma: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.67
72351505|NCT01128426|144222705|SUPERIORITY_OR_OTHER|||||||0.18|||||||mid-p exact binomial method|||Nausea and vomiting: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.18
72351506|NCT01128426|144222705|SUPERIORITY_OR_OTHER|||||||0.08|||||||mid-p exact binomial method|||Neonatal candida infection: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.08
72351507|NCT01128426|144222705|SUPERIORITY_OR_OTHER|||||||0.63|||||||mid-p exact binomial method|||Other diseases of nasal cavity and sinuses: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.63
72351508|NCT01128426|144222705|SUPERIORITY_OR_OTHER|||||||0.66|||||||mid-p exact binomial method|||Other specified cardiac dysrhythmias: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.66
72351509|NCT01128426|144222705|SUPERIORITY_OR_OTHER|||||||0.31|||||||mid-p exact binomial method|||Pneumonia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.31
72351510|NCT01128426|144222705|SUPERIORITY_OR_OTHER|||||||0.22|||||||mid-p exact binomial method|||Rash: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.22
72351511|NCT01128426|144222705|SUPERIORITY_OR_OTHER|||||||0.96|||||||mid-p exact binomial method|||Respiratory syncytial virus: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.96
72351512|NCT01128426|144222705|SUPERIORITY_OR_OTHER|||||||0.67|||||||mid-p exact binomial method|||Single seizure: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.67
72351513|NCT01128426|144222705|SUPERIORITY_OR_OTHER|||||||0.23|||||||mid-p exact binomial method|||Stomatitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.23
72351514|NCT01128426|144222705|SUPERIORITY_OR_OTHER|||||||0.14|||||||mid-p exact binomial method|||Stridor: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.14
72351515|NCT01128426|144222705|SUPERIORITY_OR_OTHER|||||||0.07|||||||mid-p exact binomial method|||Subconjunctival hemorrhage: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.07
72351516|NCT01128426|144222705|SUPERIORITY_OR_OTHER|||||||0.74|||||||mid-p exact binomial method|||Umbilical hernia without obstruction/gangrene: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.74
72351517|NCT01128426|144222705|SUPERIORITY_OR_OTHER|||||||0.69|||||||mid-p exact binomial method|||Unspecified septicemia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.69
72351518|NCT01128426|144222705|SUPERIORITY_OR_OTHER|||||||0.01|||||||mid-p exact binomial method|||Urinary tract infection: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.01
72351519|NCT01128426|144222705|SUPERIORITY_OR_OTHER|||||||0.72|||||||mid-p exact binomial method|||Urticaria: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.72
72351520|NCT01128426|144222705|SUPERIORITY_OR_OTHER|||||||0.07|||||||mid-p exact binomial method|||Vaccines adverse reaction: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.07
72351521|NCT01128426|144222705|SUPERIORITY_OR_OTHER||||||<|0.01|||||||mid-p exact binomial method|||Viral syndrome: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||<0.01
72351522|NCT01128426|144222705|SUPERIORITY_OR_OTHER|||||||0.07|||||||mid-p exact binomial method|||Weakness: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.07
72351523|NCT01128426|144222705|SUPERIORITY_OR_OTHER|||||||0.73|||||||mid-p exact binomial method|||Wheezing: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.73
72351524|NCT01128426|144222706|SUPERIORITY_OR_OTHER|||||||0.04|||||||mid-p exact binomial method|||Abnormal involuntary movements: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.04
72351525|NCT01128426|144222706|SUPERIORITY_OR_OTHER|||||||0.02|||||||mid-p exact binomial method|||Acute bronchiolitis due to RSV: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.02
72351526|NCT01128426|144222706|SUPERIORITY_OR_OTHER|||||||0.27|||||||mid-p exact binomial method|||Acute febrile mucocutaneous lymph node syndrome: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.27
72351527|NCT01128426|144222706|SUPERIORITY_OR_OTHER|||||||0.02|||||||mid-p exact binomial method|||Acute otitis media: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.02
72351528|NCT01128426|144222706|SUPERIORITY_OR_OTHER|||||||0.18|||||||mid-p exact binomial method|||Acute pyelonephritis without RMN lesion: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.18
72351529|NCT01128426|144222706|SUPERIORITY_OR_OTHER|||||||0.93|||||||mid-p exact binomial method|||Adverse drug reaction: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.93
72351530|NCT01128426|144222706|SUPERIORITY_OR_OTHER|||||||0.05|||||||mid-p exact binomial method|||Alkalosis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.05
72351531|NCT01128426|144222706|SUPERIORITY_OR_OTHER|||||||0.52|||||||mid-p exact binomial method|||Apnea: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.52
72351532|NCT01128426|144222706|SUPERIORITY_OR_OTHER|||||||0.17|||||||mid-p exact binomial method|||Apparent life threatening event infant: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.17
72351533|NCT01128426|144222706|SUPERIORITY_OR_OTHER|||||||0.21|||||||mid-p exact binomial method|||Asthma with acute exacerbation: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.21
72351534|NCT01128426|144222706|SUPERIORITY_OR_OTHER|||||||0.05|||||||mid-p exact binomial method|||Asthma, unspecified, unspecified status: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.05
72351535|NCT01128426|144222706|SUPERIORITY_OR_OTHER|||||||0.63|||||||mid-p exact binomial method|||Bronchiolitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.63
72351536|NCT01128426|144222706|SUPERIORITY_OR_OTHER|||||||0.46|||||||mid-p exact binomial method|||Bronchitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.46
72351537|NCT01128426|144222706|SUPERIORITY_OR_OTHER|||||||0.42|||||||mid-p exact binomial method|||Bronchospasm: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.42
72351538|NCT01128426|144222706|SUPERIORITY_OR_OTHER|||||||0.49|||||||mid-p exact binomial method|||Candidiasis of mouth: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.49
72351539|NCT01128426|144222706|SUPERIORITY_OR_OTHER|||||||0.69|||||||mid-p exact binomial method|||Cellulitis and abscess of trunk: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.69
72351540|NCT01128426|144222706|SUPERIORITY_OR_OTHER|||||||0.28|||||||mid-p exact binomial method|||Constipation: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.28
72351541|NCT01128426|144222706|SUPERIORITY_OR_OTHER|||||||0.69|||||||mid-p exact binomial method|||Croup: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.69
72351542|NCT01128426|144222706|SUPERIORITY_OR_OTHER|||||||0.95|||||||mid-p exact binomial method|||Dehydration: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.95
72351543|NCT01128426|144222706|SUPERIORITY_OR_OTHER|||||||0.13|||||||mid-p exact binomial method|||Dermatitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.13
72351544|NCT01128426|144222706|SUPERIORITY_OR_OTHER|||||||0.57|||||||mid-p exact binomial method|||Dyspnea: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.57
72351545|NCT01128426|144222706|SUPERIORITY_OR_OTHER|||||||0.18|||||||mid-p exact binomial method|||Failure to thrive: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.18
72351546|NCT01128426|144222706|SUPERIORITY_OR_OTHER|||||||0.03|||||||mid-p exact binomial method|||Fever: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.03
72351547|NCT01128426|144222706|SUPERIORITY_OR_OTHER|||||||0.45|||||||mid-p exact binomial method|||Fussy infant: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.45
72351548|NCT01128426|144222706|SUPERIORITY_OR_OTHER|||||||0.21|||||||mid-p exact binomial method|||Gastroenteritis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.21
72351549|NCT01128426|144222706|SUPERIORITY_OR_OTHER|||||||0.66|||||||mid-p exact binomial method|||Hand, foot and mouth disease: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.66
72351550|NCT01128426|144222706|SUPERIORITY_OR_OTHER|||||||0.67|||||||mid-p exact binomial method|||Hematoma: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.67
72351551|NCT01128426|144222706|SUPERIORITY_OR_OTHER|||||||0.04|||||||mid-p exact binomial method|||Hypopotassemia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.04
72351552|NCT01128426|144222706|SUPERIORITY_OR_OTHER|||||||0.69|||||||mid-p exact binomial method|||Lipoma of other specified sites: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.69
72351553|NCT01128426|144222706|SUPERIORITY_OR_OTHER|||||||0.53|||||||mid-p exact binomial method|||Methicillin susceptible Staphylococcus aureus: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.53
72351554|NCT01128426|144222706|SUPERIORITY_OR_OTHER|||||||0.16|||||||mid-p exact binomial method|||Nausea and vomiting: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.16
72351555|NCT01128426|144222706|SUPERIORITY_OR_OTHER|||||||0.07|||||||mid-p exact binomial method|||Neonatal bradycardia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.07
72351556|NCT01128426|144222706|SUPERIORITY_OR_OTHER|||||||0.08|||||||mid-p exact binomial method|||Neonatal candida infection: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.08
72351557|NCT01128426|144222706|SUPERIORITY_OR_OTHER|||||||0.98|||||||mid-p exact binomial method|||Other diseases of nasal cavity and sinuses: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.98
72351558|NCT01128426|144222706|SUPERIORITY_OR_OTHER|||||||0.04|||||||mid-p exact binomial method|||Other specified cardiac dysrhythmias: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.04
72351559|NCT01128426|144222706|SUPERIORITY_OR_OTHER||||||<|0.01|||||||mid-p exact binomial method|||Pilonidal cyst without mention of abscess: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||<0.01
72351560|NCT01128426|144222706|SUPERIORITY_OR_OTHER|||||||0.22|||||||mid-p exact binomial method|||Pneumonia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.22
72351561|NCT01128426|144222706|SUPERIORITY_OR_OTHER|||||||0.02|||||||mid-p exact binomial method|||Primary apnea of newborn: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.02
72351562|NCT01128426|144222706|SUPERIORITY_OR_OTHER|||||||0.17|||||||mid-p exact binomial method|||Rash: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.17
72351563|NCT01128426|144222706|SUPERIORITY_OR_OTHER|||||||0.87|||||||mid-p exact binomial method|||Respiratory syncytial virus: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.87
72351564|NCT01128426|144222706|SUPERIORITY_OR_OTHER|||||||0.07|||||||mid-p exact binomial method|||Retinopathy of prematurity stage 2: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.07
72351565|NCT01128426|144222706|SUPERIORITY_OR_OTHER|||||||0.54|||||||mid-p exact binomial method|||Single seizure: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.54
72351566|NCT01128426|144222706|SUPERIORITY_OR_OTHER|||||||0.23|||||||mid-p exact binomial method|||Stomatitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.23
72351567|NCT01128426|144222706|SUPERIORITY_OR_OTHER|||||||0.24|||||||mid-p exact binomial method|||Stridor: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.24
72351568|NCT01128426|144222706|SUPERIORITY_OR_OTHER|||||||0.24|||||||mid-p exact binomial method|||Subconjunctival hemorrhage: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.24
72351569|NCT01128426|144222706|SUPERIORITY_OR_OTHER|||||||0.04|||||||mid-p exact binomial method|||Umbilical hernia without obstruction/gangrene: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.04
72351570|NCT01128426|144222706|SUPERIORITY_OR_OTHER|||||||0.21|||||||mid-p exact binomial method|||Unspecified bacterial pneumonia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.21
72351571|NCT01128426|144222706|SUPERIORITY_OR_OTHER|||||||0.29|||||||mid-p exact binomial method|||Unspecified septicemia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.29
72351572|NCT01128426|144222706|SUPERIORITY_OR_OTHER|||||||0.06|||||||mid-p exact binomial method|||Urinary tract infection: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.06
72351573|NCT01128426|144222706|SUPERIORITY_OR_OTHER|||||||0.61|||||||mid-p exact binomial method|||Urticaria: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.61
72351574|NCT01128426|144222706|SUPERIORITY_OR_OTHER|||||||0.07|||||||mid-p exact binomial method|||Vaccines adverse reaction: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.07
72351575|NCT01128426|144222706|SUPERIORITY_OR_OTHER||||||<|0.01|||||||mid-p exact binomial method|||Viral syndrome: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||<0.01
72351576|NCT01128426|144222706|SUPERIORITY_OR_OTHER|||||||0.04|||||||mid-p exact binomial method|||Weakness: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.04
72351577|NCT01128426|144222706|SUPERIORITY_OR_OTHER|||||||0.68|||||||mid-p exact binomial method|||Wheezing: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.68
72351578|NCT00550953|144222715|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.02|STANDARD_ERROR_OF_MEAN|0.82|<|0.0001|TWO_SIDED|95.0|6.41|9.63|||ANCOVA||Difference calculated as telmisartan 40 mg plus amlodipine 5 mg fixed-dose combination minus telmisartan 40 mg monotherapy|||9.63|6.41|<0.0001
72351579|NCT00892775|144222739|NON_INFERIORITY|Non-inferiority with respect to seroconversion rates for measles 42-56 days after vaccination was concluded if the lower limit of the 95% confidence interval around the difference in seroconversion rates between groups would be \[-10%\] or higher.|Difference in percentage|-0.64|||||TWO_SIDED|95.0|-2.29|1.76||||||||1.76|-2.29|
72351580|NCT00892775|144222739|NON_INFERIORITY|Non-inferiority with respect to seroconversion rates for mumps 42-56 days after vaccination was concluded if the lower limit of the 95% CI around the difference in seroconversion rates between groups would be \[-10%\] or higher.|Difference in percentage|-0.74|||||TWO_SIDED|95.0|-6.14|5.58||||||||5.58|-6.14|
72351581|NCT00892775|144222739|NON_INFERIORITY|Non-inferiority with respect to seroconversion rates for rubella 42-56 days after vaccination was concluded if the lower limit of the 95% CI around the difference in seroconversion rates between groups would be \[-10%\] or higher.|Difference in percentage|-0.32|||||TWO_SIDED|95.0|-1.78|2.08||||||||2.08|-1.78|
72351582|NCT00892775|144222739|NON_INFERIORITY|Non-inferiority with respect to seroconversion rates for varicella 42-56 days after vaccination was concluded if the lower limit of the 95% CI around the difference in seroconversion rates between groups would be \[-10%\] or higher.|Difference in percentage|4.69|||||TWO_SIDED|95.0|0.72|10.34||||||||10.34|0.72|
72351583|NCT01773187|144222755|SUPERIORITY|||||||0.0003|||||||Fisher Exact|||Pre-specified||||0.0003
72351584|NCT01773187|144222756|SUPERIORITY|||||||0.2368|||||||Fisher Exact|||Pre-specified||||0.2368
72351585|NCT03678311|144222785|OTHER|The correlation between the outcome and AHI was tested by Spearman's correlation.|Spearman's correlation|0.13||||0.73|TWO_SIDED|95.0|-0.75|1.0|||Spearman's correlation|||Spearman's correlation was used to evaluate the relationship between the outcome and the apnea hypopnea index.||1.00|-0.75|0.73
72351586|NCT01454791|144222812|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.08||||0.45|TWO_SIDED||||||t-test, 2 sided|||||||0.45
72351587|NCT01454791|144222813|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.16||||0.6059|TWO_SIDED||||||t-test, 2 sided||not significant|||||0.6059
72351588|NCT01454791|144222814|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.18||||0.705|TWO_SIDED||||||t-test, 2 sided||not significant|||||0.705
72351589|NCT03652181|144222865|EQUIVALENCE|The null hypothesis is that the year 1 change is equivalent to year 2 change in mean QSM||||||0.033|||||||t-test, 2 sided|||||||0.033
72351590|NCT03652181|144222866|EQUIVALENCE|The null hypothesis is that the year 1 change is equivalent to year 2 change in mean DCEQP||||||0.3459|||||||t-test, 2 sided|||||||0.3459
72351591|NCT03652181|144222867|EQUIVALENCE|The null hypothesis is that the year 1 change is equivalent to year 2 numbers||||||1|||||||Chi-squared|||||||1.0
72351592|NCT00086047|144222885|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.39|STANDARD_DEVIATION|8.8||0.007|TWO_SIDED|95.0|1.57|9.22|||Mixed Models Analysis|||||9.22|1.57|0.007
72351593|NCT03573323|144222930|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
72351594|NCT03573323|144222931|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
72351595|NCT03573323|144222932|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
72351596|NCT03573323|144222933|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
72351597|NCT03573323|144222934|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
72351598|NCT03573323|144222935|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
72351599|NCT03573323|144222936|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
72351600|NCT03573323|144222937|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
72351601|NCT03573323|144222938|SUPERIORITY|||||||0.414|||||||Cochran-Mantel-Haenszel|||||||0.414
72351602|NCT04502290|144222942|SUPERIORITY|||||||0.04|||||||t-test, 2 sided|||Paired t-test was used, where null hypothesis stated that the percent change in the number of blocks after intervention will be not statistically significant.||||.04
72351603|NCT04502290|144222943|SUPERIORITY|||||||0.02|||||||t-test, 2 sided|||Paired t-test was used, where null hypothesis stated that the percent change in the motor evoked potnetial after intervention will be not statistically significant.||||.02
72351604|NCT04502290|144222944|SUPERIORITY|||||||0.04|||||||t-test, 2 sided|||Paired t-test was used, where null hypothesis stated that the percent change in the force after intervention will be not statistically significant.||||.04
72351605|NCT02326064|144222959|SUPERIORITY||||||<|0.001|||||||Mac-Nemar paired Chi-2 test|||||||<0.001
72351606|NCT02326064|144222960|SUPERIORITY||||||<|0.001|||||||Mac-Nemar paired Chi-2 test|||||||<0.001
72351607|NCT01618669|144222961|NON_INFERIORITY_OR_EQUIVALENCE|If the lower confidence bound of the 1-sided alpha level of 0.025 of the difference in the proportion of participants with majority reader self-agreement exceeded -0.075, non-inferiority would be demonstrated.|Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.015|||TWO_SIDED|95.0|-0.06|0.0|||||Difference equals Regadenoson After Peak Exercise minus Regadenoson Alone|||-0.00|-0.06|
72351608|NCT01618669|144222963|NON_INFERIORITY_OR_EQUIVALENCE|The lower confidence bound of the 1-sided alpha level of 0.025 of the difference in agreement rates must exceed -0.10 in order to demonstrate non-inferiority.|Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.063|||TWO_SIDED|95.0|-0.14|0.11|||||Difference equals Regadenoson After Peak Exercise minus Regadenoson Alone|||0.11|-0.14|
72351609|NCT01618669|144222964|NON_INFERIORITY_OR_EQUIVALENCE|The lower confidence bound of the 1-sided alpha level of 0.025 of the difference in agreement rates must exceed -0.133 in order to demonstrate non-inferiority. Non-inferiority could not be assessed because of insufficient data in the Regadenoson Alone group.|Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.027|||TWO_SIDED|95.0|-0.07|0.04||||||||0.04|-0.07|
72351610|NCT01618669|144222965|SUPERIORITY_OR_OTHER||Difference|0.02|STANDARD_ERROR_OF_MEAN|0.022|||TWO_SIDED|95.0|-0.03|0.06||||||||0.06|-0.03|
72351611|NCT04317040|144222975|OTHER|Hazard ratio (HR) and the associated 95% CIs were calculated based on Cox Regression model and p-value was calculated based on log-rank test, in accordance with the statistical analysis plan.|Hazard Ratio (HR)|1.398||||0.0367|TWO_SIDED|95.0|1.02|1.918|||Log Rank||Cox-Regression Model|||1.918|1.020|0.0367
72351612|NCT04317040|144222977|OTHER|Risk difference (RD) and the associated 95% CIs were calculated based on Mantel-Haenszel method and p-value was calculated based on Chi-squared test, in accordance with the statistical analysis plan.|Risk Difference (RD)|-0.0555||||0.3281|TWO_SIDED|95.0|-0.1665|0.0555|||Chi-squared||Mantel-Haenszel method|||0.0555|-0.1665|0.3281
72351613|NCT04317040|144222978|OTHER|Hazard ratio (HR) and the associated 95% CIs were calculated based on Cox Regression model and p-value was calculated based on log-rank test, in accordance with the statistical analysis plan.|Hazard Ratio (HR)|0.558||||0.0306|TWO_SIDED|95.0|0.327|0.954|||Log Rank||Cox Regression Model|||0.954|0.327|0.0306
72351614|NCT04317040|144222979|OTHER|Risk difference (RD) and the associated 95% CIs were calculated based on Mantel-Haenszel method and p-value was calculated based on Chi-squared test, in accordance with the statistical analysis plan.|Risk Difference (RD)|0.027||||0.4491|TWO_SIDED|95.0|-0.043|0.097|||Chi-squared||Mantel-Haenszel method used to report all-cause mortality by Day 15|Day 15||0.0970|-0.0430|0.4491
72351615|NCT04317040|144222979|OTHER|Risk difference (RD) and the associated 95% CIs were calculated based on Mantel-Haenszel method and p-value was calculated based on Chi-squared test, in accordance with the statistical analysis plan.|Risk Difference (RD)|-0.0146||||0.7512|TWO_SIDED|95.0|-0.1049|0.0756|||Chi-squared||Mantel-Haenszel method used to report all-cause mortality by Day 29|Day 29||0.0756|-0.1049|0.7512
72351616|NCT04317040|144222982|OTHER|Hazard ratio (HR) and the associated 95% CIs were calculated based on Cox Regression model and p-value was calculated based on log-rank test, in accordance with the statistical analysis plan.|Hazard Ratio (HR)|1.416||||0.0311|TWO_SIDED|95.0|1.031|1.945|||Log Rank||Cox Regression model|||1.945|1.031|0.0311
72351617|NCT01702558|144223009|SUPERIORITY||Difference in Response Rates|8.2||||0.336|TWO_SIDED|90.0|-4.5|20.9|||Fisher Exact||90% CI was estimated using Hauck-Anderson approach.|||20.9|-4.5|0.336
72351618|NCT03259087|144223065|OTHER||Geometric Least Squares Mean Ratio (GMR)|1.25|||||TWO_SIDED|90.0|1.07|1.47|||||GMR is ratio of Experimental Group / Healthy Group|||1.47|1.07|
72351619|NCT03259087|144223065|OTHER||Geometric Least Squares Mean Ratio (GMR)|1.7|||||TWO_SIDED|90.0|1.42|2.02|||||GMR is ratio of Experimental Group / Healthy Group|||2.02|1.42|
72351620|NCT03259087|144223065|OTHER||Geometric Least Squares Mean Ratio (GMR)|2.98|||||TWO_SIDED|90.0|2.2|4.04|||||GMR is ratio of Experimental Group / Healthy Group|||4.04|2.20|
72351621|NCT03259087|144223066|OTHER||Geometric Least Squares Mean Ratio (GMR)|1.25|||||TWO_SIDED|90.0|1.06|1.46|||||GMR is ratio of Experimental Group / Healthy Group|||1.46|1.06|
72351622|NCT03259087|144223066|OTHER||Geometric Least Squares Mean Ratio (GMR)|1.68|||||TWO_SIDED|90.0|1.41|1.99|||||GMR is ratio of Experimental Group / Healthy Group|||1.99|1.41|
72351623|NCT03259087|144223066|OTHER||Geometric Least Squares Mean Ratio (GMR)|2.91|||||TWO_SIDED|90.0|2.17|3.9|||||GMR is ratio of Experimental Group / Healthy Group|||3.90|2.17|
72351624|NCT03259087|144223067|OTHER||Geometric Least Squares Mean Ratio (GMR)|1.21|||||TWO_SIDED|90.0|1.04|1.4|||||GMR is ratio of Experimental Group / Healthy Group|||1.40|1.04|
72351625|NCT03259087|144223067|OTHER||Geometric Least Squares Mean Ratio (GMR)|1.59|||||TWO_SIDED|90.0|1.36|1.86|||||GMR is ratio of Experimental Group / Healthy Group|||1.86|1.36|
72351626|NCT03259087|144223067|OTHER||Geometric Least Squares Mean Ratio (GMR)|2.32|||||TWO_SIDED|90.0|1.82|2.97|||||GMR is ratio of Experimental Group / Healthy Group|||2.97|1.82|
72351627|NCT03259087|144223068|OTHER||Geometric Least Squares Mean Ratio (GMR)|0.99|||||TWO_SIDED|90.0|0.84|1.16|||||GMR is ratio of Experimental Group / Healthy Group|||1.16|0.84|
72351628|NCT03259087|144223068|OTHER||Geometric Least Squares Mean Ratio (GMR)|1.03|||||TWO_SIDED|90.0|0.9|1.18|||||GMR is ratio of Experimental Group / Healthy Group|||1.18|0.90|
72351629|NCT03259087|144223068|OTHER||Geometric Least Squares Mean Ratio (GMR)|1.11|||||TWO_SIDED|90.0|0.95|1.29|||||GMR is ratio of Experimental Group / Healthy Group|||1.29|0.95|
72351630|NCT03259087|144223070|OTHER||Geometric Least Squares Mean Ratio (GMR)|0.8|||||TWO_SIDED|90.0|0.68|0.94|||||GMR is ratio of Experimental Group / Healthy Group|||0.94|0.68|
72351631|NCT03259087|144223070|OTHER||Geometric Least Squares Mean Ratio (GMR)|0.59|||||TWO_SIDED|90.0|0.49|0.7|||||GMR is ratio of Experimental Group / Healthy Group|||0.70|0.49|
72351632|NCT03259087|144223070|OTHER||Geometric Least Squares Mean Ratio (GMR)|0.34|||||TWO_SIDED|90.0|0.25|0.45|||||GMR is ratio of Experimental Group / Healthy Group|||0.45|0.25|
72351633|NCT03259087|144223074|OTHER||Geometric Least Squares Mean Ratio (GMR)|3.97|||||TWO_SIDED|90.0|3.26|4.82|||||GMR is ratio of Experimental Group / Healthy Group|||4.82|3.26|
72351634|NCT03259087|144223074|OTHER||Geometric Least Squares Mean Ratio (GMR)|1.58|||||TWO_SIDED|90.0|1.3|1.92|||||GMR is ratio of Experimental Group / Healthy Group|||1.92|1.30|
72351635|NCT03259087|144223075|OTHER||Geometric Least Squares Mean Ratio (GMR)|3.63|||||TWO_SIDED|90.0|3.03|4.36|||||GMR is ratio of Experimental Group / Healthy Group|||4.36|3.03|
72351636|NCT03259087|144223075|OTHER||Geometric Least Squares Mean Ratio (GMR)|1.46|||||TWO_SIDED|90.0|1.22|1.75|||||GMR is ratio of Experimental Group / Healthy Group|||1.75|1.22|
72351637|NCT03259087|144223076|OTHER||Geometric Least Squares Mean Ratio (GMR)|2.61|||||TWO_SIDED|90.0|2.23|3.06|||||GMR is ratio of Experimental Group / Healthy Group|||3.06|2.23|
72351638|NCT03259087|144223076|OTHER||Geometric Least Squares Mean Ratio (GMR)|1.09|||||TWO_SIDED|90.0|0.95|1.25|||||GMR is ratio of Experimental Group / Healthy Group|||1.25|0.95|
72351639|NCT03259087|144223077|OTHER||Geometric Least Squares Mean Ratio (GMR)|0.98|||||TWO_SIDED|90.0|0.84|1.14|||||GMR is ratio of Experimental Group / Healthy Group|||1.14|0.84|
72351640|NCT03259087|144223077|OTHER||Geometric Least Squares Mean Ratio (GMR)|0.94|||||TWO_SIDED|90.0|0.75|1.2|||||GMR is ratio of Experimental Group / Healthy Group|||1.20|0.75|
72351641|NCT03259087|144223078|OTHER||Geometric Least Squares Mean Ratio (GMR)|0.99|||||TWO_SIDED|90.0|0.85|1.16|||||GMR is ratio of Experimental Group / Healthy Group|||1.16|0.85|
72351642|NCT03259087|144223078|OTHER||Geometric Least Squares Mean Ratio (GMR)|0.94|||||TWO_SIDED|90.0|0.75|1.2|||||GMR is ratio of Experimental Group / Healthy Group|||1.20|0.75|
72351643|NCT03259087|144223079|OTHER||Geometric Least Squares Mean Ratio (GMR)|0.25|||||TWO_SIDED|90.0|0.21|0.31|||||GMR is ratio of Experimental Group / Healthy Group|||0.31|0.21|
72351644|NCT03259087|144223079|OTHER||Geometric Least Squares Mean Ratio (GMR)|0.63|||||TWO_SIDED|95.0|0.52|0.77|||||GMR is ratio of Experimental Group / Healthy Group|||0.77|0.52|
72351645|NCT03259087|144223083|OTHER||Geometric Least Squares Mean Ratio (GMR)|0.9|||||TWO_SIDED|90.0|0.74|1.11|||||GMR is ratio of Experimental Group / Healthy Group|||1.11|0.74|
72351646|NCT03259087|144223083|OTHER||Geometric Least Squares Mean Ratio (GMR)|0.64|||||TWO_SIDED|90.0|0.47|0.88|||||GMR is ratio of Experimental Group / Healthy Group|||0.88|0.47|
72351647|NCT03259087|144223083|OTHER||Geometric Least Squares Mean Ratio (GMR)|0.3|||||TWO_SIDED|90.0|0.21|0.43|||||GMR is ratio of Experimental Group / Healthy Group|||0.43|0.21|
72351648|NCT03259087|144223084|OTHER||Geometric Least Squares Mean Ratio (GMR)|0.75|||||TWO_SIDED|90.0|0.57|0.98|||||GMR is ratio of Experimental Group / Healthy Group|||0.98|0.57|
72351649|NCT03259087|144223084|OTHER||Geometric Least Squares Mean Ratio (GMR)|0.4|||||TWO_SIDED|90.0|0.31|0.53|||||GMR is ratio of Experimental Group / Healthy Group|||0.53|0.31|
72351650|NCT03259087|144223084|OTHER||Geometric Least Squares Mean Ratio (GMR)|0.13|||||TWO_SIDED|90.0|0.08|0.22|||||GMR is ratio of Experimental Group / Healthy Group|||0.22|0.08|
72351651|NCT03259087|144223085|OTHER||Geometric Least Squares Mean Ratio (GMR)|0.9|||||TWO_SIDED|90.0|0.74|1.11|||||GMR is ratio of Experimental Group / Healthy Group|||1.11|0.74|
72351652|NCT03259087|144223085|OTHER||Geometric Least Squares Mean Ratio (GMR)|0.64|||||TWO_SIDED|90.0|0.47|0.88|||||GMR is ratio of Experimental Group / Healthy Group|||0.88|0.47|
72351653|NCT03259087|144223085|OTHER||Geometric Least Squares Mean Ratio (GMR)|0.3|||||TWO_SIDED|90.0|0.21|0.43|||||GMR is ratio of Experimental Group / Healthy Group|||0.43|0.21|
72351654|NCT04950465|144223102|SUPERIORITY||Mean Difference (Final Values)|0.16|STANDARD_ERROR_OF_MEAN|0.14||0.2639|TWO_SIDED|95.0|-0.12|0.43|||ANCOVA|||||0.43|-0.12|0.2639
72351655|NCT04950465|144223103|SUPERIORITY|||||||0.6978|||||||Van Elteren Test|Due to non-normal residual analyses from ANCOVA a Van Elteren Test was performed.||Week 4||||0.6978
72351656|NCT04950465|144223103|SUPERIORITY|||||||0.813|||||||Van Elteren Test|Due to non-normal residual analyses from ANCOVA a Van Elteren Test was performed.||Week 8||||0.8130
72351657|NCT04950465|144223104|SUPERIORITY||Mean Difference (Final Values)|-0.03|STANDARD_ERROR_OF_MEAN|0.115||0.7645|TWO_SIDED|95.0|-0.26|0.19|||ANCOVA|||||0.19|-0.26|0.7645
72351658|NCT04950465|144223105|SUPERIORITY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.114||0.9728|TWO_SIDED|95.0|-0.23|0.22|||ANCOVA|||Week 4||0.22|-0.23|0.9728
72351659|NCT04950465|144223105|SUPERIORITY||Mean Difference (Final Values)|0.15|STANDARD_ERROR_OF_MEAN|0.14||0.2968|TWO_SIDED|95.0|-0.13|0.42|||ANCOVA|||Week 8||0.42|-0.13|0.2968
72351660|NCT04950465|144223106|SUPERIORITY|||||||0.1682|||||||Van Elteren Test|Due to non-normal residual analyses from ANCOVA a Van Elteren Test was performed.||Week 4||||0.1682
72351661|NCT04950465|144223106|SUPERIORITY|||||||0.3937|||||||Van Elteren Test|Due to non-normal residual analyses from ANCOVA a Van Elteren Test was performed.||Week 8||||0.3937
72351662|NCT02366195|144223110|OTHER|||||||0.387|||||||Regression, Logistic|||||||0.387
72351663|NCT02366195|144223111|OTHER|Primary completion data.||||||0.056|||||||Regression, Logistic|||||||0.056
72351664|NCT02366195|144223111|OTHER|Final analysis data.||||||0.222|||||||Regression, Logistic|||||||0.222
72351665|NCT02366195|144223112|OTHER|Primary completion data||||||0.335|||||||Cox proportional hazards|||||||0.335
72351666|NCT02366195|144223112|OTHER|Final analysis data||||||0.597|||||||Cox proportional hazards|||||||0.597
72351667|NCT02366195|144223113|OTHER|Primary completion||||||0.82|||||||Fisher's Z transformation|||||||0.82
72351668|NCT02366195|144223113|OTHER|Final analysis data||||||0.9|||||||Fisher's Z transformation|||||||0.90
72351669|NCT02366195|144223114|OTHER|Primary completion data||||||0.66|||||||Regression, Logistic|||||||0.660
72351670|NCT02366195|144223114|OTHER|Final analysis data||||||0.881|||||||Regression, Logistic|||||||0.881
72351671|NCT02366195|144223115|OTHER|Primary completion data||||||0.974|||||||Regression, Logistic|||||||0.974
72351672|NCT02366195|144223115|OTHER|Final analysis data||||||0.612|||||||Regression, Logistic|||||||0.612
72351673|NCT02366195|144223116|OTHER|Primary completion data||||||0.626|||||||Cox proportional hazards|||||||0.626
72351674|NCT02366195|144223116|OTHER|Final analysis data||||||0.579|||||||Cox proportional hazards|||||||0.579
72351675|NCT02366195|144223117|OTHER|Primary completion data||||||0.18|||||||Pearson's correlation coefficient|||||||0.18
72351676|NCT02366195|144223117|OTHER|Final analysis data||||||0.14|||||||Pearson's correlation coefficient|||||||0.14
72351677|NCT01010971|144223153|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.02|||<|0.0001|TWO_SIDED|95.0|0.59|1.45||The p-value from primary outcome was adjusted at alpha=0.025.|ANCOVA|||The null hypothesis is that there is no difference in primary outcome when compare active to placebo group. The alternative hypothesis is that there is a difference in primary outcome when compare active to placebo group. It was estimated that 200 subjects per group will provide at least 85% power to detect a difference between treatment groups of 0.7 in the change from baseline in rTNSS with a two-sided alpha level of 0.025.||1.45|0.59|<0.0001
72351678|NCT01010971|144223153|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.04|||<|0.0001|TWO_SIDED|95.0|0.61|1.46||The p-value from primary outcome was adjusted at alpha=0.025.|ANCOVA|||The null hypothesis is that there is no difference in primary outcome when compare active to placebo group. The alternative hypothesis is that there is a difference in primary outcome when compare active to placebo group. It was estimated that 200 subjects per group will provide at least 85% power to detect a difference between treatment groups of 0.7 in the change from baseline in rTNSS with a two-sided alpha level of 0.025.||1.46|0.61|<0.0001
72351679|NCT01010971|144223154|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.18|||<|0.0001|TWO_SIDED|95.0|0.07|0.29|||ANCOVA|||Dmitrienko's tree-structured gatekeeping method was used for multiple comparisons||0.29|0.07|<0.0001
72351680|NCT01010971|144223154|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.19|||<|0.0001|TWO_SIDED|95.0|0.08|0.29|||ANCOVA|||Dmitrienko's tree-structured gatekeeping method was used for multiple comparisons||0.29|0.08|<0.0001
72351681|NCT01010971|144223155|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.34||||0.1444|TWO_SIDED|95.0|-0.03|0.71||Dmitrienko's tree-structured gatekeeping method was used for multiple comparisons|ANCOVA|||Dmitrienko's tree-structured gatekeeping method was used for multiple comparisons||0.71|-0.03|0.1444
72351682|NCT01010971|144223155|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.52||||0.0124|TWO_SIDED|95.0|0.15|0.89||Dmitrienko's tree-structured gatekeeping method was used for multiple comparisons|ANCOVA|||Dmitrienko's tree-structured gatekeeping method was used for multiple comparisons||0.89|0.15|0.0124
72351683|NCT01010971|144223156|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.62||||0.0124|TWO_SIDED|95.0|0.3|0.94||Dmitrienko's tree-structured gatekeeping method was used for multiple comparisons|ANCOVA|||||0.94|0.30|0.0124
72351684|NCT01010971|144223156|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.64|||||TWO_SIDED|95.0|0.33|0.95||Dmitrienko's tree-structured gatekeeping method was used for multiple comparisons|ANCOVA|||||0.95|0.33|
72351685|NCT01369784|144223212|SUPERIORITY_OR_OTHER|||||||0.812|||||||Fisher Exact|||||||0.812
72351686|NCT01369784|144223213|SUPERIORITY_OR_OTHER|||||||0.612|||||||Chi-squared|||||||0.612
72351687|NCT01369784|144223214|SUPERIORITY_OR_OTHER|||||||0.402|||||||Chi-squared|||||||0.402
72351688|NCT01369784|144223215|SUPERIORITY_OR_OTHER|||||||0.557|||||||Chi-squared|||||||0.557
72351689|NCT01369784|144223216|SUPERIORITY_OR_OTHER|||||||0.234|||||||Chi-squared|||||||0.234
72351690|NCT01369784|144223217|SUPERIORITY_OR_OTHER|||||||0.057|||||||Fisher Exact|||||||0.057
72351691|NCT01369784|144223218|SUPERIORITY_OR_OTHER|||||||0.117|||||||Fisher Exact|||||||0.117
72351692|NCT02905266|144223220|SUPERIORITY||Percent Difference in incidence rates|0.0|||||TWO_SIDED|95.0|0.0|0.0|||||Fixed Ratio Combination over Sequential Combination|||0.0|0.0|
72351693|NCT02905266|144223228|SUPERIORITY||Percent Difference of ORRs|-7.5|||||TWO_SIDED|95.0|-26.1|11.0|||||Cochran-Mantel-Haenszel (CMH) method of weighting|||11.0|-26.1|
72351694|NCT02905266|144223228|SUPERIORITY||Odds Ratio (OR)|0.75|||||TWO_SIDED|95.0|0.35|1.58||||||||1.58|0.35|
72351695|NCT02905266|144223229|SUPERIORITY||Hazard Ratio (HR)|1.36|||||TWO_SIDED|95.0|0.78|2.37|||||Stratified Cox proportional hazard model|||2.37|0.78|
72351696|NCT02905266|144223230|SUPERIORITY||Cochran-Mantel-Haenszel Odds Ratio|0.87|||||TWO_SIDED|95.0|0.3|2.49|||||Fixed Ratio Combination over Sequential Combination|||2.49|0.30|
72351697|NCT02905266|144223230|SUPERIORITY||Percent difference in incidence rates|-1.9|||||TWO_SIDED|95.0|-16.0|12.2|||||Fixed Ratio Combination over Sequential Combination|||12.2|-16.0|
72351698|NCT03884790|144223237|OTHER|Descriptive statistical analysis|||||||||||||||||Descriptive statistical analysis|||
72351699|NCT04378270|144223244|OTHER||Mean Difference (Final Values)|2.93|STANDARD_ERROR_OF_MEAN|1.61||0.0796|TWO_SIDED|95.0|-0.3687|6.2287|||t-test, 2 sided|Degrees of Freedom (DF)- 28||This procedure calculates the difference between the observed means in two independent samples (two collected assessment timepoints, screening and 4 week follow up visits). A significance value (P-value) and 95% Confidence Interval (CI) of the difference is reported. The P-value is the probability of obtaining the observed difference between the samples if the null hypothesis were true. The null hypothesis is the hypothesis that the difference is 0.||6.2287|-0.3687|0.0796
72351700|NCT04378270|144223245|OTHER||Mean Difference (Final Values)|-1.7|STANDARD_ERROR_OF_MEAN|0.879||0.0634|TWO_SIDED|95.0|-3.5014|0.1014|||t-test, 2 sided|Degrees of Freedom (DF)- 28||This procedure calculates the difference between the observed means in two independent samples (two collected assessment timepoints, screening and 4 week follow up visits). A significance value (P-value) and 95% Confidence Interval (CI) of the difference is reported. The P-value is the probability of obtaining the observed difference between the samples if the null hypothesis were true. The null hypothesis is the hypothesis that the difference is 0.||0.1014|-3.5014|0.0634
72351701|NCT04378270|144223246|OTHER||Mean Difference (Final Values)|18.7|STANDARD_ERROR_OF_MEAN|5.492||0.002|TWO_SIDED|95.0|7.4498|29.9502|||t-test, 2 sided|Degrees of Freedom (DF)- 28||This procedure calculates the difference between the observed means in two independent samples (two collected assessment timepoints, screening and 4 week follow up visits). A significance value (P-value) and 95% confidence interval (CI) of the difference is reported. The P value is the probability of obtaining the observed difference between the samples if the null hypothesis were true. The null hypothesis is the hypothesis that the difference is 0.||29.9502|7.4498|0.0020
72351702|NCT04378270|144223247|OTHER||Mean Difference (Net)|16.67|STANDARD_ERROR_OF_MEAN|4.327||0.0006|TWO_SIDED|95.0|7.8069|25.5331|||t-test, 2 sided|Degrees of freedom (DF)- 28||||25.5331|7.8069|0.0006
72351703|NCT04378270|144223250|OTHER||Mean pain scale|17.87|STANDARD_DEVIATION|2.39||0.0001|TWO_SIDED|95.0|16.5465|19.1935|||t-test, 2 sided|Degrees of freedom (DF)- 14||This procedure calculates the difference of an observed mean (from the assessment collected at the 4 week visit) with a hypothesized mean value (10, a mid level scale score). A significance value (P-value) and 95% Confidence Interval (CI) of the observed mean is reported. The P-value is the probability of obtaining the observed mean in the sample if the null hypothesis value were the true value.||19.1935|16.5465|0.0001
72351704|NCT03201419|144223276|SUPERIORITY||Mean Difference|-0.3|||||TWO_SIDED|95.0|-0.54|-0.07||||||Based on a Bayesian analysis of a sigmoidal dose-response relationship.||-0.07|-0.54|
72351705|NCT03201419|144223276|SUPERIORITY||Mean Difference|-0.23|||||TWO_SIDED|95.0|-0.46|-0.02||||||Based on a Bayesian analysis of a sigmoidal dose-response relationship.||-0.02|-0.46|
72351706|NCT03201419|144223276|SUPERIORITY||Mean Difference|-0.14|||||TWO_SIDED|95.0|-0.36|0.0||||||Based on a Bayesian analysis of a sigmoidal dose-response relationship.||-0.00|-0.36|
72351707|NCT03201419|144223276|SUPERIORITY||Mean Difference|-0.04|||||TWO_SIDED|95.0|-0.23|0.0||||||Based on a Bayesian analysis of a sigmoidal dose-response relationship.||-0.00|-0.23|
72351708|NCT03201419|144223276|SUPERIORITY||Mean Difference|-0.02|||||TWO_SIDED|95.0|-0.14|0.0||||||Based on a Bayesian analysis of a sigmoidal dose-response relationship.||-0.00|-0.14|
72351709|NCT03201419|144223276|SUPERIORITY||Mean Difference|-0.01|||||TWO_SIDED|95.0|-0.07|0.0||||||Based on a Bayesian analysis of a sigmoidal dose-response relationship.||-0.00|-0.07|
72351710|NCT03201419|144223277|SUPERIORITY||Mean Difference|-0.139||||0.4214|TWO_SIDED|95.0|-0.48|0.201||Threshold for significance at 0.05 level.|MMRM|||||0.201|-0.480|0.4214
72351711|NCT03201419|144223277|SUPERIORITY||Mean Difference|-0.587||||0.0101|TWO_SIDED|95.0|-1.034|-0.141||Threshold for significance at 0.05 level.|MMRM|||||-0.141|-1.034|0.0101
72351712|NCT03201419|144223277|SUPERIORITY||Mean Difference|-0.148||||0.5203|TWO_SIDED|95.0|-0.599|0.304||Threshold for significance at 0.05 level.|MMRM|||||0.304|-0.599|0.5203
72351713|NCT03201419|144223277|SUPERIORITY||Mean Difference|0.055||||0.8483|TWO_SIDED|95.0|-0.508|0.617||Threshold for significance at 0.05 level.|MMRM|||||0.617|-0.508|0.8483
72351714|NCT03201419|144223277|SUPERIORITY||Mean Difference|-0.147||||0.6357|TWO_SIDED|95.0|-0.759|0.464||Threshold for significance at 0.05 level.|MMRM|||||0.464|-0.759|0.6357
72351715|NCT03201419|144223277|SUPERIORITY||Mean Difference|0.25||||0.2222|TWO_SIDED|95.0|-0.152|0.652||Threshold for significance at 0.05 level.|MMRM|||||0.652|-0.152|0.2222
72351716|NCT03201419|144223278|SUPERIORITY||Mean Difference|-0.166||||0.2909|TWO_SIDED|95.0|-0.474|0.143||Threshold for significance at 0.05 level.|MMRM|||||0.143|-0.474|0.2909
72351717|NCT03201419|144223278|SUPERIORITY||Mean Difference|-0.418||||0.044|TWO_SIDED|95.0|-0.824|-0.011||Threshold for significance at 0.05 level.|MMRM|||||-0.011|-0.824|0.0440
72351718|NCT03201419|144223278|SUPERIORITY||Mean Difference|0.128||||0.5438|TWO_SIDED|95.0|-0.288|0.545||Threshold for significance at 0.05 level.|MMRM|||||0.545|-0.288|0.5438
72351719|NCT03201419|144223278|SUPERIORITY||Mean Difference|0.441||||0.096|TWO_SIDED|95.0|-0.079|0.962||Threshold for significance at 0.05 level.|MMRM|||||0.962|-0.079|0.0960
72351720|NCT03201419|144223278|SUPERIORITY||Mean Difference|-0.04||||0.8826|TWO_SIDED|95.0|-0.568|0.488||Threshold for significance at 0.05 level.|MMRM|||||0.488|-0.568|0.8826
72351721|NCT03201419|144223278|SUPERIORITY||Mean Difference|0.394||||0.0344|TWO_SIDED|95.0|0.029|0.759||Threshold for significance at 0.05 level.|MMRM|||||0.759|0.029|0.0344
72351722|NCT03201419|144223279|SUPERIORITY||Mean Difference|-0.132||||0.4732|TWO_SIDED|95.0|-0.496|0.231||Threshold for significance at 0.05 level.|MMRM|||||0.231|-0.496|0.4732
72351723|NCT03201419|144223279|SUPERIORITY||Mean Difference|-0.224||||0.3394|TWO_SIDED|95.0|-0.685|0.237||Threshold for significance at 0.05 level.|MMRM|||||0.237|-0.685|0.3394
72351724|NCT03201419|144223279|SUPERIORITY||Mean Difference|-0.012||||0.96|TWO_SIDED|95.0|-0.488|0.463||Threshold for significance at 0.05 level.|MMRM|||||0.463|-0.488|0.9600
72351725|NCT03201419|144223279|SUPERIORITY||Mean Difference|0.463||||0.1131|TWO_SIDED|95.0|-0.111|1.037||Threshold for significance at 0.05 level.|MMRM|||||1.037|-0.111|0.1131
72351726|NCT03201419|144223279|SUPERIORITY||Mean Difference|-0.124||||0.6853|TWO_SIDED|95.0|-0.729|0.48||Threshold for significance at 0.05 level.|MMRM|||||0.480|-0.729|0.6853
72351727|NCT03201419|144223279|SUPERIORITY||Mean Difference|0.166||||0.4364|TWO_SIDED|95.0|-0.254|0.587||Threshold for significance at 0.05 level.|MMRM|||||0.587|-0.254|0.4364
72351728|NCT03201419|144223280|SUPERIORITY||Mean Difference|-0.299||||0.1106|TWO_SIDED|95.0|-0.667|0.069||Threshold for significance at 0.05 level.|MMRM|||||0.069|-0.667|0.1106
72351729|NCT03201419|144223280|SUPERIORITY||Mean Difference|-0.163||||0.5005|TWO_SIDED|95.0|-0.639|0.313||Threshold for significance at 0.05 level.|MMRM|||||0.313|-0.639|0.5005
72351730|NCT03201419|144223280|SUPERIORITY||Mean Difference|0.107||||0.6604|TWO_SIDED|95.0|-0.372|0.586||Threshold for significance at 0.05 level.|MMRM|||||0.586|-0.372|0.6604
72351731|NCT03201419|144223280|SUPERIORITY||Mean Difference|0.283||||0.3178|TWO_SIDED|95.0|-0.275|0.842||Threshold for significance at 0.05 level.|MMRM|||||0.842|-0.275|0.3178
72351732|NCT03201419|144223280|SUPERIORITY||Mean Difference|-0.096||||0.7561|TWO_SIDED|95.0|-0.701|0.51||Threshold for significance at 0.05 level.|MMRM|||||0.510|-0.701|0.7561
72351733|NCT03201419|144223280|SUPERIORITY||Mean Difference|0.037||||0.8614|TWO_SIDED|95.0|-0.378|0.452||Threshold for significance at 0.05 level.|MMRM|||||0.452|-0.378|0.8614
72351734|NCT03201419|144223281|SUPERIORITY||Odds Ratio (OR)|1.759||||0.117|TWO_SIDED|95.0|0.869|3.56||Threshold for significance at 0.05 level.|Regression, Logistic|||||3.560|0.869|0.117
72351735|NCT03201419|144223281|SUPERIORITY||Odds Ratio (OR)|2.505||||0.048|TWO_SIDED|95.0|1.01|6.214||Threshold for significance at 0.05 level.|Regression, Logistic|||||6.214|1.010|0.048
72351736|NCT03201419|144223281|SUPERIORITY||Odds Ratio (OR)|1.42||||0.46|TWO_SIDED|95.0|0.56|3.602||Threshold for significance at 0.05 level.|Regression, Logistic|||||3.602|0.560|0.460
72351737|NCT03201419|144223281|SUPERIORITY||Odds Ratio (OR)|1.704||||0.367|TWO_SIDED|95.0|0.535|5.427||Threshold for significance at 0.05 level.|Regression, Logistic|||||5.427|0.535|0.367
72351738|NCT03201419|144223281|SUPERIORITY||Odds Ratio (OR)|1.689||||0.407|TWO_SIDED|95.0|0.489|5.825||Threshold for significance at 0.05 level.|Regression, Logistic|||||5.825|0.489|0.407
72351739|NCT03201419|144223281|SUPERIORITY||Odds Ratio (OR)|1.069||||0.876|TWO_SIDED|95.0|0.462|2.473||Threshold for significance at 0.05 level.|Regression, Logistic|||||2.473|0.462|0.876
72351740|NCT03201419|144223282|SUPERIORITY||Odds Ratio (OR)|0.971||||0.937|TWO_SIDED|95.0|0.47|2.005||Threshold for significance at 0.05 level.|Regression, Logistic|||||2.005|0.470|0.937
72351741|NCT03201419|144223282|SUPERIORITY||Odds Ratio (OR)|4.738||||0.028|TWO_SIDED|95.0|1.183|18.968||Threshold for significance at 0.05 level.|Regression, Logistic|||||18.968|1.183|0.028
72351742|NCT03201419|144223282|SUPERIORITY||Odds Ratio (OR)|0.513||||0.166|TWO_SIDED|95.0|0.2|1.318||Threshold for significance at 0.05 level.|Regression, Logistic|||||1.318|0.200|0.166
72351743|NCT03201419|144223282|SUPERIORITY||Odds Ratio (OR)|0.433||||0.174|TWO_SIDED|95.0|0.129|1.447||Threshold for significance at 0.05 level.|Regression, Logistic|||||1.447|0.129|0.174
72351744|NCT03201419|144223282|SUPERIORITY||Odds Ratio (OR)|1.425||||0.608|TWO_SIDED|95.0|0.369|5.512||Threshold for significance at 0.05 level.|Regression, Logistic|||||5.512|0.369|0.608
72351745|NCT03201419|144223282|SUPERIORITY||Odds Ratio (OR)|0.553||||0.171|TWO_SIDED|95.0|0.237|1.292||Threshold for significance at 0.05 level.|Regression, Logistic|||||1.292|0.237|0.171
72351746|NCT03201419|144223283|SUPERIORITY||Odds Ratio (OR)|0.928||||0.85|TWO_SIDED|95.0|0.43|2.003||Threshold for significance at 0.05 level.|Regression, Logistic|||||2.003|0.430|0.850
72351747|NCT03201419|144223283|SUPERIORITY||Odds Ratio (OR)|2.261||||0.15|TWO_SIDED|95.0|0.745|6.862||Threshold for significance at 0.05 level.|Regression, Logistic|||||6.862|0.745|0.150
72351748|NCT03201419|144223283|SUPERIORITY||Odds Ratio (OR)|1.283||||0.632|TWO_SIDED|95.0|0.462|3.566||Threshold for significance at 0.05 level.|Regression, Logistic|||||3.566|0.462|0.632
72351749|NCT03201419|144223283|SUPERIORITY||Odds Ratio (OR)|0.583||||0.363|TWO_SIDED|95.0|0.183|1.863||Threshold for significance at 0.05 level.|Regression, Logistic|||||1.863|0.183|0.363
72351750|NCT03201419|144223283|SUPERIORITY||Odds Ratio (OR)|0.691||||0.555|TWO_SIDED|95.0|0.203|2.359||Threshold for significance at 0.05 level.|Regression, Logistic|||||2.359|0.203|0.555
72351751|NCT03201419|144223283|SUPERIORITY||Odds Ratio (OR)|0.991||||0.984|TWO_SIDED|95.0|0.408|2.405||Threshold for significance at 0.05 level.|Regression, Logistic|||||2.405|0.408|0.984
72351752|NCT03201419|144223284|SUPERIORITY||Odds Ratio (OR)|2.462||||0.046|TWO_SIDED|95.0|1.017|5.961||Threshold for significance at 0.05 level.|Regression, Logistic|||||5.961|1.017|0.046
72351753|NCT03201419|144223284|SUPERIORITY||Odds Ratio (OR)|1.19||||0.745|TWO_SIDED|95.0|0.418|3.386||Threshold for significance at 0.05 level.|Regression, Logistic|||||3.386|0.418|0.745
72351754|NCT03201419|144223284|SUPERIORITY||Odds Ratio (OR)|1.147||||0.79|TWO_SIDED|95.0|0.417|3.155||Threshold for significance at 0.05 level.|Regression, Logistic|||||3.155|0.417|0.790
72351755|NCT03201419|144223284|SUPERIORITY||Odds Ratio (OR)|0.537||||0.293|TWO_SIDED|95.0|0.169|1.71||Threshold for significance at 0.05 level.|Regression, Logistic|||||1.710|0.169|0.293
72351756|NCT03201419|144223284|SUPERIORITY||Odds Ratio (OR)|0.881||||0.843|TWO_SIDED|95.0|0.252|3.076||Threshold for significance at 0.05 level.|Regression, Logistic|||||3.076|0.252|0.843
72351757|NCT03201419|144223284|SUPERIORITY||Odds Ratio (OR)|0.877||||0.763|TWO_SIDED|95.0|0.375|2.053||Threshold for significance at 0.05 level.|Regression, Logistic|||||2.053|0.375|0.763
72351758|NCT03201419|144223285|SUPERIORITY||Odds Ratio (OR)|1.422|||||TWO_SIDED|95.0|0.868|2.597||||||Based on a Bayesian analysis of a sigmoidal dose-response relationship.||2.597|0.868|
72351759|NCT03201419|144223285|SUPERIORITY||Odds Ratio (OR)|1.373|||||TWO_SIDED|95.0|0.905|2.45||||||Based on a Bayesian analysis of a sigmoidal dose-response relationship.||2.450|0.905|
72351760|NCT03201419|144223285|SUPERIORITY||Odds Ratio (OR)|1.284|||||TWO_SIDED|95.0|0.927|2.264||||||Based on a Bayesian analysis of a sigmoidal dose-response relationship.||2.264|0.927|
72351761|NCT03201419|144223285|SUPERIORITY||Odds Ratio (OR)|1.145|||||TWO_SIDED|95.0|0.957|1.896||||||Based on a Bayesian analysis of a sigmoidal dose-response relationship.||1.896|0.957|
72351762|NCT03201419|144223285|SUPERIORITY||Odds Ratio (OR)|1.079|||||TWO_SIDED|95.0|0.972|1.638||||||Based on a Bayesian analysis of a sigmoidal dose-response relationship.||1.638|0.972|
72351763|NCT03201419|144223285|SUPERIORITY||Odds Ratio (OR)|1.023|||||TWO_SIDED|95.0|0.991|1.313||||||Based on a Bayesian analysis of a sigmoidal dose-response relationship.||1.313|0.991|
72351764|NCT03201419|144223286|SUPERIORITY||Mean Difference|0.52||||0.8463|TWO_SIDED|95.0|-4.75|5.78||Threshold for significance at 0.05 level.|MMRM|||||5.78|-4.75|0.8463
72351765|NCT03201419|144223286|SUPERIORITY||Mean Difference|-13.85||||0.0001|TWO_SIDED|95.0|-20.89|-6.81||Threshold for significance at 0.05 level.|MMRM|||||-6.81|-20.89|0.0001
72351766|NCT03201419|144223286|SUPERIORITY||Mean Difference|-2.84||||0.4355|TWO_SIDED|95.0|-9.99|4.32||Threshold for significance at 0.05 level.|MMRM|||||4.32|-9.99|0.4355
72351767|NCT03201419|144223286|SUPERIORITY||Mean Difference|-0.87||||0.8483|TWO_SIDED|95.0|-9.79|8.06||Threshold for significance at 0.05 level.|MMRM|||||8.06|-9.79|0.8483
72351768|NCT03201419|144223286|SUPERIORITY||Mean Difference|-1.61||||0.7336|TWO_SIDED|95.0|-10.91|7.69||Threshold for significance at 0.05 level.|MMRM|||||7.69|-10.91|0.7336
72351769|NCT03201419|144223286|SUPERIORITY||Mean Difference|-0.69||||0.8347|TWO_SIDED|95.0|-7.15|5.78||Threshold for significance at 0.05 level.|MMRM|||||5.78|-7.15|0.8347
72351770|NCT03201419|144223287|SUPERIORITY||Mean Difference|1.59||||0.5695|TWO_SIDED|95.0|-3.9|7.07||Threshold for significance at 0.05 level.|MMRM|||||7.07|-3.90|0.5695
72351771|NCT03201419|144223287|SUPERIORITY||Mean Difference|-3.23||||0.3784|TWO_SIDED|95.0|-10.46|3.99||Threshold for significance at 0.05 level.|MMRM|||||3.99|-10.46|0.3784
72351772|NCT03201419|144223287|SUPERIORITY||Mean Difference|-0.17||||0.9653|TWO_SIDED|95.0|-7.67|7.34||Threshold for significance at 0.05 level.|MMRM|||||7.34|-7.67|0.9653
72351773|NCT03201419|144223287|SUPERIORITY||Mean Difference|2.97||||0.5304|TWO_SIDED|95.0|-6.35|12.29||Threshold for significance at 0.05 level.|MMRM|||||12.29|-6.35|0.5304
72351774|NCT03201419|144223287|SUPERIORITY||Mean Difference|-8.02||||0.0968|TWO_SIDED|95.0|-17.51|1.46||Threshold for significance at 0.05 level.|MMRM|||||1.46|-17.51|0.0968
72351775|NCT03201419|144223287|SUPERIORITY||Mean Difference|0.91||||0.7885|TWO_SIDED|95.0|-5.79|7.62||Threshold for significance at 0.05 level.|MMRM|||||7.62|-5.79|0.7885
72351776|NCT03201419|144223288|SUPERIORITY||Mean Difference|-1.2||||0.6792|TWO_SIDED|95.0|-6.89|4.5||Threshold for significance at 0.05 level.|MMRM|||||4.50|-6.89|0.6792
72351777|NCT03201419|144223288|SUPERIORITY||Mean Difference|-8.39||||0.0276|TWO_SIDED|95.0|-15.84|-0.93||Threshold for significance at 0.05 level.|MMRM|||||-0.93|-15.84|0.0276
72351778|NCT03201419|144223288|SUPERIORITY||Mean Difference|-0.27||||0.9445|TWO_SIDED|95.0|-7.97|7.42||Threshold for significance at 0.05 level.|MMRM|||||7.42|-7.97|0.9445
72351779|NCT03201419|144223288|SUPERIORITY||Mean Difference|2.79||||0.5637|TWO_SIDED|95.0|-6.71|12.28||Threshold for significance at 0.05 level.|MMRM|||||12.28|-6.71|0.5637
72351780|NCT03201419|144223288|SUPERIORITY||Mean Difference|-4.4||||0.387|TWO_SIDED|95.0|-14.39|5.6||Threshold for significance at 0.05 level.|MMRM|||||5.60|-14.39|0.3870
72351781|NCT03201419|144223288|SUPERIORITY||Mean Difference|0.72||||0.8373|TWO_SIDED|95.0|-6.19|7.63||Threshold for significance at 0.05 level.|MMRM|||||7.63|-6.19|0.8373
72351782|NCT03201419|144223289|SUPERIORITY||Mean Difference|0.53||||0.8646|TWO_SIDED|95.0|-5.54|6.59||Threshold for significance at 0.05 level.|MMRM|||||6.59|-5.54|0.8646
72351783|NCT03201419|144223289|SUPERIORITY||Mean Difference|-6.99||||0.087|TWO_SIDED|95.0|-15.0|1.02||Threshold for significance at 0.05 level.|MMRM|||||1.02|-15.00|0.0870
72351784|NCT03201419|144223289|SUPERIORITY||Mean Difference|2.77||||0.51|TWO_SIDED|95.0|-5.5|11.04||Threshold for significance at 0.05 level.|MMRM|||||11.04|-5.50|0.5100
72351785|NCT03201419|144223289|SUPERIORITY||Mean Difference|7.32||||0.1535|TWO_SIDED|95.0|-2.75|17.39||Threshold for significance at 0.05 level.|MMRM|||||17.39|-2.75|0.1535
72351786|NCT03201419|144223289|SUPERIORITY||Mean Difference|-5.14||||0.3369|TWO_SIDED|95.0|-15.66|5.38||Threshold for significance at 0.05 level.|MMRM|||||5.38|-15.66|0.3369
72351787|NCT03201419|144223289|SUPERIORITY||Mean Difference|0.27||||0.9417|TWO_SIDED|95.0|-7.05|7.59||Threshold for significance at 0.05 level.|MMRM|||||7.59|-7.05|0.9417
72351788|NCT03201419|144223290|SUPERIORITY||Median difference|0.0|||||TWO_SIDED|95.0|-1.41|5.47||||||Based on a Bayesian analysis of a sigmoidal dose-response relationship.||5.47|-1.41|
72351789|NCT03201419|144223290|SUPERIORITY||Median difference|0.0|||||TWO_SIDED|95.0|-0.43|1.19||||||Based on a Bayesian analysis of a sigmoidal dose-response relationship.||1.19|-0.43|
72351790|NCT03201419|144223290|SUPERIORITY||Median difference|0.0|||||TWO_SIDED|95.0|-0.16|0.5||||||Based on a Bayesian analysis of a sigmoidal dose-response relationship.||0.50|-0.16|
72351791|NCT03201419|144223290|SUPERIORITY||Median difference|0.0|||||TWO_SIDED|95.0|-0.03|0.15||||||Based on a Bayesian analysis of a sigmoidal dose-response relationship.||0.15|-0.03|
72351792|NCT03201419|144223290|SUPERIORITY||Median difference|0.0|||||TWO_SIDED|95.0|-0.01|0.05||||||Based on a Bayesian analysis of a sigmoidal dose-response relationship.||0.05|-0.01|
72351793|NCT03201419|144223290|SUPERIORITY||Median difference|0.0|||||TWO_SIDED|95.0|0.0|0.01||||||Based on a Bayesian analysis of a sigmoidal dose-response relationship.||0.01|-0.00|
72351794|NCT03201419|144223291|SUPERIORITY||Mean Difference|5.2||||0.3328|TWO_SIDED|95.0|-5.3|15.7||Threshold for significance at 0.05 level.|ANCOVA|||||15.7|-5.3|0.3328
72351795|NCT03201419|144223291|SUPERIORITY||Mean Difference|15.5||||0.0255|TWO_SIDED|95.0|1.9|29.2||Threshold for significance at 0.05 level.|ANCOVA|||||29.2|1.9|0.0255
72351796|NCT03201419|144223291|SUPERIORITY||Mean Difference|2.5||||0.7296|TWO_SIDED|95.0|-11.7|16.7||Threshold for significance at 0.05 level.|ANCOVA|||||16.7|-11.7|0.7296
72351797|NCT03201419|144223291|SUPERIORITY||Mean Difference|-6.7||||0.4586|TWO_SIDED|95.0|-24.5|11.1||Threshold for significance at 0.05 level.|ANCOVA|||||11.1|-24.5|0.4586
72351798|NCT03201419|144223291|SUPERIORITY||Mean Difference|11.2||||0.2327|TWO_SIDED|95.0|-7.2|29.5||Threshold for significance at 0.05 level.|ANCOVA|||||29.5|-7.2|0.2327
72351799|NCT03201419|144223291|SUPERIORITY||Mean Difference|-0.6||||0.924|TWO_SIDED|95.0|-13.3|12.1||Threshold for significance at 0.05 level.|ANCOVA|||||12.1|-13.3|0.9240
72351800|NCT03201419|144223292|SUPERIORITY||Mean Difference|0.3||||0.9499|TWO_SIDED|95.0|-7.9|8.5||Threshold for significance at 0.05 level.|ANCOVA|||||8.5|-7.9|0.9499
72351801|NCT03201419|144223292|SUPERIORITY||Mean Difference|5.8||||0.2842|TWO_SIDED|95.0|-4.8|16.4||Threshold for significance at 0.05 level.|ANCOVA|||||16.4|-4.8|0.2842
72351802|NCT03201419|144223292|SUPERIORITY||Mean Difference|-5.7||||0.31|TWO_SIDED|95.0|-16.8|5.4||Threshold for significance at 0.05 level.|ANCOVA|||||5.4|-16.8|0.3100
72351803|NCT03201419|144223292|SUPERIORITY||Mean Difference|-10.1||||0.1499|TWO_SIDED|95.0|-23.9|3.7||Threshold for significance at 0.05 level.|ANCOVA|||||3.7|-23.9|0.1499
72351804|NCT03201419|144223292|SUPERIORITY||Mean Difference|-8.2||||0.2571|TWO_SIDED|95.0|-22.5|6.0||Threshold for significance at 0.05 level.|ANCOVA|||||6.0|-22.5|0.2571
72351805|NCT03201419|144223292|SUPERIORITY||Mean Difference|-1.5||||0.7629|TWO_SIDED|95.0|-11.4|8.3||Threshold for significance at 0.05 level.|ANCOVA|||||8.3|-11.4|0.7629
72351806|NCT03201419|144223293|SUPERIORITY||Mean Difference|2.48||||0.4846|TWO_SIDED|95.0|-4.5|9.46||Threshold for significance at 0.05 level.|MMRM|||||9.46|-4.50|0.4846
72351807|NCT03201419|144223293|SUPERIORITY||Mean Difference|-16.93||||0.0004|TWO_SIDED|95.0|-26.26|-7.6||Threshold for significance at 0.05 level.|MMRM|||||-7.60|-26.26|0.0004
72351808|NCT03201419|144223293|SUPERIORITY||Mean Difference|-2.05||||0.6685|TWO_SIDED|95.0|-11.47|7.37||Threshold for significance at 0.05 level.|MMRM|||||7.37|-11.47|0.6685
72351809|NCT03201419|144223293|SUPERIORITY||Mean Difference|1.69||||0.7772|TWO_SIDED|95.0|-10.07|13.46||Threshold for significance at 0.05 level.|MMRM|||||13.46|-10.07|0.7772
72351810|NCT03201419|144223293|SUPERIORITY||Mean Difference|10.67||||0.0895|TWO_SIDED|95.0|-1.66|23.0||Threshold for significance at 0.05 level.|MMRM|||||23.00|-1.66|0.0895
72351811|NCT03201419|144223293|SUPERIORITY||Mean Difference|1.2||||0.782|TWO_SIDED|95.0|-7.34|9.74|||MMRM|||||9.74|-7.34|0.7820
72351812|NCT03201419|144223294|SUPERIORITY||Mean Difference|-0.41||||0.9175|TWO_SIDED|95.0|-8.25|7.42||Threshold for significance at 0.05 level.|MMRM|||||7.42|-8.25|0.9175
72351813|NCT03201419|144223294|SUPERIORITY||Mean Difference|-4.32||||0.4098|TWO_SIDED|95.0|-14.62|5.98||Threshold for significance at 0.05 level.|MMRM|||||5.98|-14.62|0.4098
72351814|NCT03201419|144223294|SUPERIORITY||Mean Difference|2.41||||0.6566|TWO_SIDED|95.0|-8.25|13.06||Threshold for significance at 0.05 level.|MMRM|||||13.06|-8.25|0.6566
72351815|NCT03201419|144223294|SUPERIORITY||Mean Difference|3.39||||0.6144|TWO_SIDED|95.0|-9.85|16.63||Threshold for significance at 0.05 level.|MMRM|||||16.63|-9.85|0.6144
72351816|NCT03201419|144223294|SUPERIORITY||Mean Difference|3.8||||0.5798|TWO_SIDED|95.0|-9.71|17.31||Threshold for significance at 0.05 level.|MMRM|||||17.31|-9.71|0.5798
72351817|NCT03201419|144223294|SUPERIORITY||Mean Difference|0.35||||0.9417|TWO_SIDED|95.0|-9.17|9.88||Threshold for significance at 0.05 level.|MMRM|||||9.88|-9.17|0.9417
72351818|NCT03201419|144223295|SUPERIORITY||Mean Difference|-2.81||||0.5148|TWO_SIDED|95.0|-11.31|5.68||Threshold for significance at 0.05 level.|MMRM|||||5.68|-11.31|0.5148
72351819|NCT03201419|144223295|SUPERIORITY||Mean Difference|-9.65||||0.0879|TWO_SIDED|95.0|-20.75|1.44||Threshold for significance at 0.05 level.|MMRM|||||1.44|-20.75|0.0879
72351820|NCT03201419|144223295|SUPERIORITY||Mean Difference|3.61||||0.5335|TWO_SIDED|95.0|-7.79|15.0||Threshold for significance at 0.05 level.|MMRM|||||15.00|-7.79|0.5335
72351821|NCT03201419|144223295|SUPERIORITY||Mean Difference|6.29||||0.3787|TWO_SIDED|95.0|-7.76|20.34||Threshold for significance at 0.05 level.|MMRM|||||20.34|-7.76|0.3787
72351822|NCT03201419|144223295|SUPERIORITY||Mean Difference|1.48||||0.8448|TWO_SIDED|95.0|-13.41|16.38||Threshold for significance at 0.05 level.|MMRM|||||16.38|-13.41|0.8448
72351823|NCT03201419|144223295|SUPERIORITY||Mean Difference|4.62||||0.3751|TWO_SIDED|95.0|-5.63|14.87||Threshold for significance at 0.05 level.|MMRM|||||14.87|-5.63|0.3751
72351824|NCT03201419|144223296|SUPERIORITY||Mean Difference|-0.43||||0.9245|TWO_SIDED|95.0|-9.43|8.57||Threshold for significance at 0.05 level.|MMRM|||||8.57|-9.43|0.9245
72351825|NCT03201419|144223296|SUPERIORITY||Mean Difference|-6.72||||0.2657|TWO_SIDED|95.0|-18.59|5.15||Threshold for significance at 0.05 level.|MMRM|||||5.15|-18.59|0.2657
72351826|NCT03201419|144223296|SUPERIORITY||Mean Difference|9.2||||0.1383|TWO_SIDED|95.0|-2.99|21.38||Threshold for significance at 0.05 level.|MMRM|||||21.38|-2.99|0.1383
72351827|NCT03201419|144223296|SUPERIORITY||Mean Difference|14.72||||0.0523|TWO_SIDED|95.0|-0.15|29.59||Threshold for significance at 0.05 level.|MMRM|||||29.59|-0.15|0.0523
72351828|NCT03201419|144223296|SUPERIORITY||Mean Difference|1.14||||0.8855|TWO_SIDED|95.0|-14.47|16.75||Threshold for significance at 0.05 level.|MMRM|||||16.75|-14.47|0.8855
72351829|NCT03201419|144223296|SUPERIORITY||Mean Difference|2.91||||0.5972|TWO_SIDED|95.0|-7.91|13.72||Threshold for significance at 0.05 level.|MMRM|||||13.72|-7.91|0.5972
72351830|NCT03201419|144223297|SUPERIORITY||Mean Difference|-0.54|||||TWO_SIDED|95.0|-6.09|2.28||||||Based on a Bayesian analysis of a sigmoidal dose-response relationship.||2.28|-6.09|
72351831|NCT03201419|144223297|SUPERIORITY||Mean Difference|-0.28|||||TWO_SIDED|95.0|-4.3|0.75||||||Based on a Bayesian analysis of a sigmoidal dose-response relationship.||0.75|-4.30|
72351832|NCT03201419|144223297|SUPERIORITY||Mean Difference|-0.15|||||TWO_SIDED|95.0|-2.44|0.33||||||Based on a Bayesian analysis of a sigmoidal dose-response relationship.||0.33|-2.44|
72351833|NCT03201419|144223297|SUPERIORITY||Mean Difference|-0.04|||||TWO_SIDED|95.0|-0.92|0.07||||||Based on a Bayesian analysis of a sigmoidal dose-response relationship.||0.07|-0.92|
72351834|NCT03201419|144223297|SUPERIORITY||Mean Difference|-0.02|||||TWO_SIDED|95.0|-0.48|0.02||||||Based on a Bayesian analysis of a sigmoidal dose-response relationship.||0.02|-0.48|
72351835|NCT03201419|144223297|SUPERIORITY||Mean Difference|0.0|||||TWO_SIDED|95.0|-0.15|0.0||||||Based on a Bayesian analysis of a sigmoidal dose-response relationship.||0.00|-0.15|
72351836|NCT03201419|144223298|SUPERIORITY||Mean Difference|-0.27||||0.055|TWO_SIDED|95.0|-0.545|0.006||Threshold for significance at 0.05 level.|MMRM|||||0.006|-0.545|0.0550
72351837|NCT03201419|144223298|SUPERIORITY||Mean Difference|-0.7||||0.0002|TWO_SIDED|95.0|-1.066|-0.335||Threshold for significance at 0.05 level.|MMRM|||||-0.335|-1.066|0.0002
72351838|NCT03201419|144223298|SUPERIORITY||Mean Difference|-0.037||||0.844|TWO_SIDED|95.0|-0.404|0.33||Threshold for significance at 0.05 level.|MMRM|||||0.330|-0.404|0.8440
72351839|NCT03201419|144223298|SUPERIORITY||Mean Difference|0.041||||0.861|TWO_SIDED|95.0|-0.417|0.498||Threshold for significance at 0.05 level.|MMRM|||||0.498|-0.417|0.8610
72351840|NCT03201419|144223298|SUPERIORITY||Mean Difference|0.036||||0.8871|TWO_SIDED|95.0|-0.46|0.532||Threshold for significance at 0.05 level.|MMRM|||||0.532|-0.460|0.8871
72351841|NCT03201419|144223298|SUPERIORITY||Mean Difference|0.013||||0.9396|TWO_SIDED|95.0|-0.313|0.338||Threshold for significance at 0.05 level.|MMRM|||||0.338|-0.313|0.9396
72351842|NCT03201419|144223299|SUPERIORITY||Mean Difference|-0.475||||0.005|TWO_SIDED|95.0|-0.806|-0.145||Threshold for significance at 0.05 level.|MMRM|||||-0.145|-0.806|0.0050
72351843|NCT03201419|144223299|SUPERIORITY||Mean Difference|-0.405||||0.0665|TWO_SIDED|95.0|-0.837|0.028||Threshold for significance at 0.05 level.|MMRM|||||0.028|-0.837|0.0665
72351844|NCT03201419|144223299|SUPERIORITY||Mean Difference|-0.149||||0.5245|TWO_SIDED|95.0|-0.608|0.31||Threshold for significance at 0.05 level.|MMRM|||||0.310|-0.608|0.5245
72351845|NCT03201419|144223299|SUPERIORITY||Mean Difference|-0.075||||0.7947|TWO_SIDED|95.0|-0.642|0.492||Threshold for significance at 0.05 level.|MMRM|||||0.492|-0.642|0.7947
72351846|NCT03201419|144223299|SUPERIORITY||Mean Difference|-0.211||||0.4625|TWO_SIDED|95.0|-0.777|0.355||Threshold for significance at 0.05 level.|MMRM|||||0.355|-0.777|0.4625
72351847|NCT03201419|144223299|SUPERIORITY||Mean Difference|-0.014||||0.9465|TWO_SIDED|95.0|-0.412|0.385||Threshold for significance at 0.05 level.|MMRM|||||0.385|-0.412|0.9465
72351848|NCT03201419|144223300|SUPERIORITY||Mean Difference|-0.73|||<|0.0001|TWO_SIDED|95.0|-1.078|-0.383||Threshold for significance at 0.05 level.|MMRM|||||-0.383|-1.078|<0.0001
72351849|NCT03201419|144223300|SUPERIORITY||Mean Difference|-0.686||||0.003|TWO_SIDED|95.0|-1.137|-0.236||Threshold for significance at 0.05 level.|MMRM|||||-0.236|-1.137|0.0030
72351850|NCT03201419|144223300|SUPERIORITY||Mean Difference|-0.045||||0.852|TWO_SIDED|95.0|-0.517|0.427||Threshold for significance at 0.05 level.|MMRM|||||0.427|-0.517|0.8520
72351851|NCT03201419|144223300|SUPERIORITY||Mean Difference|-0.287||||0.3205|TWO_SIDED|95.0|-0.856|0.281||Threshold for significance at 0.05 level.|MMRM|||||0.281|-0.856|0.3205
72351852|NCT03201419|144223300|SUPERIORITY||Mean Difference|-0.418||||0.1769|TWO_SIDED|95.0|-1.026|0.19||Threshold for significance at 0.05 level.|MMRM|||||0.190|-1.026|0.1769
72351853|NCT03201419|144223300|SUPERIORITY||Mean Difference|-0.3||||0.1584|TWO_SIDED|95.0|-0.717|0.118||Threshold for significance at 0.05 level.|MMRM|||||0.118|-0.717|0.1584
72351854|NCT03201419|144223301|SUPERIORITY||Mean Difference|-0.822|||<|0.0001|TWO_SIDED|95.0|-1.22|-0.424||Threshold for significance at 0.05 level.|MMRM|||||-0.424|-1.220|<0.0001
72351855|NCT03201419|144223301|SUPERIORITY||Mean Difference|-0.818||||0.0019|TWO_SIDED|95.0|-1.331|-0.306||Threshold for significance at 0.05 level.|MMRM|||||-0.306|-1.331|0.0019
72351856|NCT03201419|144223301|SUPERIORITY||Mean Difference|0.167||||0.551|TWO_SIDED|95.0|-0.383|0.716||Threshold for significance at 0.05 level.|MMRM|||||0.716|-0.383|0.5510
72351857|NCT03201419|144223301|SUPERIORITY||Mean Difference|-0.038||||0.9086|TWO_SIDED|95.0|-0.685|0.61||Threshold for significance at 0.05 level.|MMRM|||||0.610|-0.685|0.9086
72351858|NCT03201419|144223301|SUPERIORITY||Mean Difference|-0.812||||0.0185|TWO_SIDED|95.0|-1.486|-0.138||Threshold for significance at 0.05 level.|MMRM|||||-0.138|-1.486|0.0185
72351859|NCT03201419|144223301|SUPERIORITY||Mean Difference|-0.106||||0.6537|TWO_SIDED|95.0|-0.569|0.357||Threshold for significance at 0.05 level.|MMRM|||||0.357|-0.569|0.6537
72351860|NCT03201419|144223302|SUPERIORITY||Least Square Mean Difference|-0.146||||0.235|TWO_SIDED|95.0|-0.388|0.096||Threshold for significance at 0.05 level.|MMRM|||||0.096|-0.388|0.2350
72351861|NCT03201419|144223302|SUPERIORITY||Least Square Mean Difference|-0.377||||0.0215|TWO_SIDED|95.0|-0.699|-0.056||Threshold for significance at 0.05 level.|MMRM|||||-0.056|-0.699|0.0215
72351862|NCT03201419|144223302|SUPERIORITY||Least Square Mean Difference|-0.218||||0.1818|TWO_SIDED|95.0|-0.54|0.103||Threshold for significance at 0.05 level.|MMRM|||||0.103|-0.540|0.1818
72351863|NCT03201419|144223302|SUPERIORITY||Least Square Mean Difference|-0.05||||0.8063|TWO_SIDED|95.0|-0.45|0.35||Threshold for significance at 0.05 level.|MMRM|||||0.350|-0.450|0.8063
72351864|NCT03201419|144223302|SUPERIORITY||Least Square Mean Difference|0.176||||0.4414|TWO_SIDED|95.0|-0.274|0.627||Threshold for significance at 0.05 level.|MMRM|||||0.627|-0.274|0.4414
72351865|NCT03201419|144223302|SUPERIORITY||Least Square Mean Difference|-0.126||||0.4179|TWO_SIDED|95.0|-0.432|0.18||Threshold for significance at 0.05 level.|MMRM|||||0.180|-0.432|0.4179
72351866|NCT03201419|144223303|SUPERIORITY||Least Square Mean Difference|0.061||||0.6042|TWO_SIDED|95.0|-0.17|0.292||Threshold for significance at 0.05 level.|MMRM|||||0.292|-0.170|0.6042
72351867|NCT03201419|144223303|SUPERIORITY||Least Square Mean Difference|-0.127||||0.4114|TWO_SIDED|95.0|-0.432|0.177||Threshold for significance at 0.05 level.|MMRM|||||0.177|-0.432|0.4114
72351868|NCT03201419|144223303|SUPERIORITY||Least Square Mean Difference|0.099||||0.5394|TWO_SIDED|95.0|-0.219|0.418||Threshold for significance at 0.05 level.|MMRM|||||0.418|-0.219|0.5394
72351869|NCT03201419|144223303|SUPERIORITY||Least Square Mean Difference|0.149||||0.459|TWO_SIDED|95.0|-0.246|0.544||Threshold for significance at 0.05 level.|MMRM|||||0.544|-0.246|0.4590
72351870|NCT03201419|144223303|SUPERIORITY||Least Square Mean Difference|0.242||||0.2397|TWO_SIDED|95.0|-0.163|0.647||Threshold for significance at 0.05 level.|MMRM|||||0.647|-0.163|0.2397
72351871|NCT03201419|144223303|SUPERIORITY||Least Square Mean Difference|-0.039||||0.7954|TWO_SIDED|95.0|-0.332|0.254||Threshold for significance at 0.05 level.|MMRM|||||0.254|-0.332|0.7954
72351872|NCT03201419|144223304|SUPERIORITY||Least Square Mean Difference|-0.332||||0.0077|TWO_SIDED|95.0|-0.576|-0.089||Threshold for significance at 0.05 level.|MMRM|||||-0.089|-0.576|0.0077
72351873|NCT03201419|144223304|SUPERIORITY||Least Square Mean Difference|-0.61||||0.0002|TWO_SIDED|95.0|-0.927|-0.293||Threshold for significance at 0.05 level.|MMRM|||||-0.293|-0.927|0.0002
72351874|NCT03201419|144223304|SUPERIORITY||Least Square Mean Difference|-0.026||||0.8778|TWO_SIDED|95.0|-0.352|0.301||Threshold for significance at 0.05 level.|MMRM|||||0.301|-0.352|0.8778
72351875|NCT03201419|144223304|SUPERIORITY||Least Square Mean Difference|0.157||||0.4309|TWO_SIDED|95.0|-0.235|0.549||Threshold for significance at 0.05 level.|MMRM|||||0.549|-0.235|0.4309
72351876|NCT03201419|144223304|SUPERIORITY||Least Square Mean Difference|-0.017||||0.9392|TWO_SIDED|95.0|-0.444|0.411||Threshold for significance at 0.05 level.|MMRM|||||0.411|-0.444|0.9392
72351877|NCT03201419|144223304|SUPERIORITY||Least Square Mean Difference|-0.213||||0.1734|TWO_SIDED|95.0|-0.521|0.094||Threshold for significance at 0.05 level.|MMRM|||||0.094|-0.521|0.1734
72351878|NCT03201419|144223305|SUPERIORITY||Least Square Mean Difference|-0.328||||0.0133|TWO_SIDED|95.0|-0.587|-0.069||Threshold for significance at 0.05 level.|MMRM|||||-0.069|-0.587|0.0133
72351879|NCT03201419|144223305|SUPERIORITY||Least Square Mean Difference|-0.484||||0.0048|TWO_SIDED|95.0|-0.819|-0.15||Threshold for significance at 0.05 level.|MMRM|||||-0.150|-0.819|0.0048
72351880|NCT03201419|144223305|SUPERIORITY||Least Square Mean Difference|-0.04||||0.8223|TWO_SIDED|95.0|-0.395|0.314||Threshold for significance at 0.05 level.|MMRM|||||0.314|-0.395|0.8223
72351881|NCT03201419|144223305|SUPERIORITY||Least Square Mean Difference|0.215||||0.3083|TWO_SIDED|95.0|-0.2|0.63||Threshold for significance at 0.05 level.|MMRM|||||0.630|-0.200|0.3083
72351882|NCT03201419|144223305|SUPERIORITY||Least Square Mean Difference|-0.315||||0.1556|TWO_SIDED|95.0|-0.75|0.121||Threshold for significance at 0.05 level.|MMRM|||||0.121|-0.750|0.1556
72351883|NCT03201419|144223305|SUPERIORITY||Least Square Mean Difference|-0.188||||0.2423|TWO_SIDED|95.0|-0.504|0.128||Threshold for significance at 0.05 level.|MMRM|||||0.128|-0.504|0.2423
72351884|NCT03201419|144223306|SUPERIORITY||Least Square Mean Difference|-0.079||||0.6381|TWO_SIDED|95.0|-0.409|0.251||Threshold for significance at 0.05 level.|MMRM|||||0.251|-0.409|0.6381
72351885|NCT03201419|144223306|SUPERIORITY||Least Square Mean Difference|-0.502||||0.0221|TWO_SIDED|95.0|-0.931|-0.073||Threshold for significance at 0.05 level.|MMRM|||||-0.073|-0.931|0.0221
72351886|NCT03201419|144223306|SUPERIORITY||Least Square Mean Difference|-0.177||||0.4112|TWO_SIDED|95.0|-0.602|0.247||Threshold for significance at 0.05 level.|MMRM|||||0.247|-0.602|0.4112
72351887|NCT03201419|144223306|SUPERIORITY||Least Square Mean Difference|0.112||||0.6761|TWO_SIDED|95.0|-0.416|0.64||Threshold for significance at 0.05 level.|MMRM|||||0.640|-0.416|0.6761
72351888|NCT03201419|144223306|SUPERIORITY||Least Square Mean Difference|0.224||||0.4898|TWO_SIDED|95.0|-0.414|0.861||Threshold for significance at 0.05 level.|MMRM|||||0.861|-0.414|0.4898
72351889|NCT03201419|144223306|SUPERIORITY||Least Square Mean Difference|0.194||||0.3311|TWO_SIDED|95.0|-0.198|0.585||Threshold for significance at 0.05 level.|MMRM|||||0.585|-0.198|0.3311
72351890|NCT03201419|144223307|SUPERIORITY||Least Square Mean Difference|-0.23||||0.1583|TWO_SIDED|95.0|-0.551|0.09||Threshold for significance at 0.05 level.|MMRM|||||0.090|-0.551|0.1583
72351891|NCT03201419|144223307|SUPERIORITY||Least Square Mean Difference|-0.275||||0.1884|TWO_SIDED|95.0|-0.685|0.136||Threshold for significance at 0.05 level.|MMRM|||||0.136|-0.685|0.1884
72351892|NCT03201419|144223307|SUPERIORITY||Least Square Mean Difference|-0.047||||0.8256|TWO_SIDED|95.0|-0.463|0.369||Threshold for significance at 0.05 level.|MMRM|||||0.369|-0.463|0.8256
72351893|NCT03201419|144223307|SUPERIORITY||Least Square Mean Difference|0.059||||0.8198|TWO_SIDED|95.0|-0.455|0.574||Threshold for significance at 0.05 level.|MMRM|||||0.574|-0.455|0.8198
72351894|NCT03201419|144223307|SUPERIORITY||Least Square Mean Difference|-0.431||||0.1793|TWO_SIDED|95.0|-1.061|0.199||Threshold for significance at 0.05 level.|MMRM|||||0.199|-1.061|0.1793
72351895|NCT03201419|144223307|SUPERIORITY||Least Square Mean Difference|-0.196||||0.3155|TWO_SIDED|95.0|-0.581|0.189||Threshold for significance at 0.05 level.|MMRM|||||0.189|-0.581|0.3155
72351896|NCT03201419|144223308|SUPERIORITY||Least Square Mean Difference|-0.241||||0.183|TWO_SIDED|95.0|-0.596|0.114||Threshold for significance at 0.05 level.|MMRM|||||0.114|-0.596|0.1830
72351897|NCT03201419|144223308|SUPERIORITY||Least Square Mean Difference|-0.313||||0.1618|TWO_SIDED|95.0|-0.751|0.126||Threshold for significance at 0.05 level.|MMRM|||||0.126|-0.751|0.1618
72351898|NCT03201419|144223308|SUPERIORITY||Least Square Mean Difference|-0.26||||0.2519|TWO_SIDED|95.0|-0.706|0.186||Threshold for significance at 0.05 level.|MMRM|||||0.186|-0.706|0.2519
72351899|NCT03201419|144223308|SUPERIORITY||Least Square Mean Difference|0.232||||0.4044|TWO_SIDED|95.0|-0.316|0.781||Threshold for significance at 0.05 level.|MMRM|||||0.781|-0.316|0.4044
72351900|NCT03201419|144223308|SUPERIORITY||Least Square Mean Difference|-0.28||||0.4348|TWO_SIDED|95.0|-0.986|0.426||Threshold for significance at 0.05 level.|MMRM|||||0.426|-0.986|0.4348
72351901|NCT03201419|144223308|SUPERIORITY||Least Square Mean Difference|-0.15||||0.4786|TWO_SIDED|95.0|-0.565|0.266||Threshold for significance at 0.05 level.|MMRM|||||0.266|-0.565|0.4786
72351902|NCT03201419|144223309|SUPERIORITY||Least Square Mean Difference|-0.223||||0.2412|TWO_SIDED|95.0|-0.598|0.151||Threshold for significance at 0.05 level.|MMRM|||||0.151|-0.598|0.2412
72351903|NCT03201419|144223309|SUPERIORITY||Least Square Mean Difference|-0.48||||0.0501|TWO_SIDED|95.0|-0.959|0.0||Threshold for significance at 0.05 level.|MMRM|||||0.000|-0.959|0.0501
72351904|NCT03201419|144223309|SUPERIORITY||Least Square Mean Difference|0.069||||0.7788|TWO_SIDED|95.0|-0.417|0.556||Threshold for significance at 0.05 level.|MMRM|||||0.556|-0.417|0.7788
72351905|NCT03201419|144223309|SUPERIORITY||Least Square Mean Difference|-0.111||||0.7111|TWO_SIDED|95.0|-0.698|0.477||Threshold for significance at 0.05 level.|MMRM|||||0.477|-0.698|0.7111
72351906|NCT03201419|144223309|SUPERIORITY||Least Square Mean Difference|-0.205||||0.5816|TWO_SIDED|95.0|-0.937|0.527||Threshold for significance at 0.05 level.|MMRM|||||0.527|-0.937|0.5816
72351907|NCT03201419|144223309|SUPERIORITY||Least Square Mean Difference|-0.152||||0.4981|TWO_SIDED|95.0|-0.595|0.29||Threshold for significance at 0.05 level.|MMRM|||||0.290|-0.595|0.4981
72351908|NCT03201419|144223310|SUPERIORITY||Least Square Mean Difference|-1.313||||0.1733|TWO_SIDED|95.0|-3.207|0.582||Threshold for significance at 0.05 level.|MMRM|||||0.582|-3.207|0.1733
72351909|NCT03201419|144223310|SUPERIORITY||Least Square Mean Difference|-1.375||||0.2538|TWO_SIDED|95.0|-3.745|0.994||Threshold for significance at 0.05 level.|MMRM|||||0.994|-3.745|0.2538
72351910|NCT03201419|144223310|SUPERIORITY||Least Square Mean Difference|-0.353||||0.7782|TWO_SIDED|95.0|-2.818|2.113||Threshold for significance at 0.05 level.|MMRM|||||2.113|-2.818|0.7782
72351911|NCT03201419|144223310|SUPERIORITY||Least Square Mean Difference|-0.151||||0.9218|TWO_SIDED|95.0|-3.182|2.88||Threshold for significance at 0.05 level.|MMRM|||||2.880|-3.182|0.9218
72351912|NCT03201419|144223310|SUPERIORITY||Least Square Mean Difference|0.767||||0.6823|TWO_SIDED|95.0|-2.923|4.457||Threshold for significance at 0.05 level.|MMRM|||||4.457|-2.923|0.6823
72351913|NCT03201419|144223310|SUPERIORITY||Least Square Mean Difference|-1.095||||0.3436|TWO_SIDED|95.0|-3.369|1.179||Threshold for significance at 0.05 level.|MMRM|||||1.179|-3.369|0.3436
72351914|NCT03201419|144223311|SUPERIORITY||Least Square Mean Difference|-1.235||||0.2042|TWO_SIDED|95.0|-3.146|0.676||Threshold for significance at 0.05 level.|MMRM|||||0.676|-3.146|0.2042
72351915|NCT03201419|144223311|SUPERIORITY||Least Square Mean Difference|-1.683||||0.1591|TWO_SIDED|95.0|-4.031|0.665||Threshold for significance at 0.05 level.|MMRM|||||0.665|-4.031|0.1591
72351916|NCT03201419|144223311|SUPERIORITY||Least Square Mean Difference|-0.285||||0.8168|TWO_SIDED|95.0|-2.708|2.138||Threshold for significance at 0.05 level.|MMRM|||||2.138|-2.708|0.8168
72351917|NCT03201419|144223311|SUPERIORITY||Least Square Mean Difference|-0.551||||0.7148|TWO_SIDED|95.0|-3.517|2.416||Threshold for significance at 0.05 level.|MMRM|||||2.416|-3.517|0.7148
72351918|NCT03201419|144223311|SUPERIORITY||Least Square Mean Difference|0.701||||0.7141|TWO_SIDED|95.0|-3.066|4.468||Threshold for significance at 0.05 level.|MMRM|||||4.468|-3.066|0.7141
72351919|NCT03201419|144223311|SUPERIORITY||Least Square Mean Difference|-0.759||||0.5041|TWO_SIDED|95.0|-2.995|1.477||Threshold for significance at 0.05 level.|MMRM|||||1.477|-2.995|0.5041
72351920|NCT03201419|144223312|SUPERIORITY||Least Square Mean Difference|-1.129||||0.2896|TWO_SIDED|95.0|-3.226|0.967||Threshold for significance at 0.05 level.|MMRM|||||0.967|-3.226|0.2896
72351921|NCT03201419|144223312|SUPERIORITY||Least Square Mean Difference|-2.652||||0.0498|TWO_SIDED|95.0|-5.301|-0.003||Threshold for significance at 0.05 level.|MMRM|||||-0.003|-5.301|0.0498
72351922|NCT03201419|144223312|SUPERIORITY||Least Square Mean Difference|0.323||||0.8159|TWO_SIDED|95.0|-2.409|3.055||Threshold for significance at 0.05 level.|MMRM|||||3.055|-2.409|0.8159
72351923|NCT03201419|144223312|SUPERIORITY||Least Square Mean Difference|0.485||||0.7719|TWO_SIDED|95.0|-2.809|3.779||Threshold for significance at 0.05 level.|MMRM|||||3.779|-2.809|0.7719
72351924|NCT03201419|144223312|SUPERIORITY||Least Square Mean Difference|1.676||||0.4193|TWO_SIDED|95.0|-2.407|5.76||Threshold for significance at 0.05 level.|MMRM|||||5.760|-2.407|0.4193
72351925|NCT03201419|144223312|SUPERIORITY||Least Square Mean Difference|-1.23||||0.3333|TWO_SIDED|95.0|-3.73|1.27||Threshold for significance at 0.05 level.|MMRM|||||1.270|-3.730|0.3333
72351926|NCT03201419|144223313|SUPERIORITY||Mean Difference|41.8||||0.0853|TWO_SIDED|95.0|-5.9|89.6||Threshold for significance at 0.05 level.|MMRM|||||89.6|-5.9|0.0853
72351927|NCT03201419|144223313|SUPERIORITY||Mean Difference|105.9||||0.001|TWO_SIDED|95.0|43.4|168.4||Threshold for significance at 0.05 level.|MMRM|||||168.4|43.4|0.0010
72351928|NCT03201419|144223313|SUPERIORITY||Mean Difference|24.9||||0.4418|TWO_SIDED|95.0|-38.8|88.6||Threshold for significance at 0.05 level.|MMRM|||||88.6|-38.8|0.4418
72351929|NCT03201419|144223313|SUPERIORITY||Mean Difference|10.7||||0.7902|TWO_SIDED|95.0|-68.2|89.6||Threshold for significance at 0.05 level.|MMRM|||||89.6|-68.2|0.7902
72351930|NCT03201419|144223313|SUPERIORITY||Mean Difference|1.8||||0.9664|TWO_SIDED|95.0|-84.2|87.9||Threshold for significance at 0.05 level.|MMRM|||||87.9|-84.2|0.9664
72351931|NCT03201419|144223313|SUPERIORITY||Mean Difference|-29.8||||0.2977|TWO_SIDED|95.0|-85.9|26.4||Threshold for significance at 0.05 level.|MMRM|||||26.4|-85.9|0.2977
72351932|NCT03201419|144223314|SUPERIORITY||Mean Difference|14.3||||0.5523|TWO_SIDED|95.0|-33.0|61.5||Threshold for significance at 0.05 level.|MMRM|||||61.5|-33.0|0.5523
72351933|NCT03201419|144223314|SUPERIORITY||Mean Difference|60.8||||0.0556|TWO_SIDED|95.0|-1.5|123.0||Threshold for significance at 0.05 level.|MMRM|||||123.0|-1.5|0.0556
72351934|NCT03201419|144223314|SUPERIORITY||Mean Difference|-17.9||||0.5837|TWO_SIDED|95.0|-82.0|46.3||Threshold for significance at 0.05 level.|MMRM|||||46.3|-82.0|0.5837
72351935|NCT03201419|144223314|SUPERIORITY||Mean Difference|-60.7||||0.1363|TWO_SIDED|95.0|-140.7|19.3||Threshold for significance at 0.05 level.|MMRM|||||19.3|-140.7|0.1363
72351936|NCT03201419|144223314|SUPERIORITY||Mean Difference|-28.2||||0.4938|TWO_SIDED|95.0|-109.1|52.8||Threshold for significance at 0.05 level.|MMRM|||||52.8|-109.1|0.4938
72351937|NCT03201419|144223314|SUPERIORITY||Mean Difference|-54.7||||0.0535|TWO_SIDED|95.0|-110.2|0.8||Threshold for significance at 0.05 level.|MMRM|||||0.8|-110.2|0.0535
72351938|NCT03201419|144223315|SUPERIORITY||Mean Difference|-0.7||||0.9829|TWO_SIDED|95.0|-62.2|60.9||Threshold for significance at 0.05 level.|MMRM|||||60.9|-62.2|0.9829
72351939|NCT03201419|144223315|SUPERIORITY||Mean Difference|64.4||||0.1038|TWO_SIDED|95.0|-13.3|142.1||Threshold for significance at 0.05 level.|MMRM|||||142.1|-13.3|0.1038
72351940|NCT03201419|144223315|SUPERIORITY||Mean Difference|29.2||||0.4764|TWO_SIDED|95.0|-51.4|109.8||Threshold for significance at 0.05 level.|MMRM|||||109.8|-51.4|0.4764
72351941|NCT03201419|144223315|SUPERIORITY||Mean Difference|-24.2||||0.6204|TWO_SIDED|95.0|-120.5|72.0||Threshold for significance at 0.05 level.|MMRM|||||72.0|-120.5|0.6204
72351942|NCT03201419|144223315|SUPERIORITY||Mean Difference|2.2||||0.966|TWO_SIDED|95.0|-100.1|104.6||Threshold for significance at 0.05 level.|MMRM|||||104.6|-100.1|0.9660
72351943|NCT03201419|144223315|SUPERIORITY||Mean Difference|3.3||||0.9275|TWO_SIDED|95.0|-67.4|73.9||Threshold for significance at 0.05 level.|MMRM|||||73.9|-67.4|0.9275
72351944|NCT03201419|144223316|SUPERIORITY||Mean Difference|15.7||||0.5964|TWO_SIDED|95.0|-42.7|74.2||Threshold for significance at 0.05 level.|MMRM|||||74.2|-42.7|0.5964
72351945|NCT03201419|144223316|SUPERIORITY||Mean Difference|-2.8||||0.9418|TWO_SIDED|95.0|-78.5|72.9||Threshold for significance at 0.05 level.|MMRM|||||72.9|-78.5|0.9418
72351946|NCT03201419|144223316|SUPERIORITY||Mean Difference|18.0||||0.6452|TWO_SIDED|95.0|-58.8|94.7||Threshold for significance at 0.05 level.|MMRM|||||94.7|-58.8|0.6452
72351947|NCT03201419|144223316|SUPERIORITY||Mean Difference|-51.3||||0.2565|TWO_SIDED|95.0|-140.2|37.6||Threshold for significance at 0.05 level.|MMRM|||||37.6|-140.2|0.2565
72351948|NCT03201419|144223316|OTHER||Mean Difference|-21.6||||0.6605|TWO_SIDED|95.0|-118.6|75.4||Threshold for significance at 0.05 level.|MMRM|||||75.4|-118.6|0.6605
72351949|NCT03201419|144223316|SUPERIORITY||Mean Difference|3.4||||0.9191|TWO_SIDED|95.0|-62.6|69.4||Threshold for significance at 0.05 level.|MMRM|||||69.4|-62.6|0.9191
72351950|NCT03201419|144223317|SUPERIORITY||Mean Difference|17.52|||||TWO_SIDED|95.0|-6.19|62.09||||||Based on a Bayesian analysis of a sigmoidal dose-response relationship.||62.09|-6.19|
72351951|NCT03201419|144223317|SUPERIORITY||Mean Difference|12.78|||||TWO_SIDED|95.0|-0.73|55.89||||||Based on a Bayesian analysis of a sigmoidal dose-response relationship.||55.89|-0.73|
72351952|NCT03201419|144223317|SUPERIORITY||Mean Difference|8.5|||||TWO_SIDED|95.0|-0.14|47.28||||||Based on a Bayesian analysis of a sigmoidal dose-response relationship.||47.28|-0.14|
72351953|NCT03201419|144223317|SUPERIORITY||Mean Difference|3.29|||||TWO_SIDED|95.0|-0.01|28.07||||||Based on a Bayesian analysis of a sigmoidal dose-response relationship.||28.07|-0.01|
72351954|NCT03201419|144223317|SUPERIORITY||Mean Difference|1.74|||||TWO_SIDED|95.0|0.0|17.9||||||Based on a Bayesian analysis of a sigmoidal dose-response relationship.||17.90|-0.00|
72351955|NCT03201419|144223317|SUPERIORITY||Mean Difference|0.68|||||TWO_SIDED|95.0|0.0|7.55||||||Based on a Bayesian analysis of a sigmoidal dose-response relationship.||7.55|-0.00|
72351956|NCT03201419|144223318|SUPERIORITY||Mean Difference|-0.173||||0.0196|TWO_SIDED|95.0|-0.318|-0.028||Threshold for significance at 0.05 level.|MMRM|||||-0.028|-0.318|0.0196
72351957|NCT03201419|144223318|SUPERIORITY||Mean Difference|-0.233||||0.0167|TWO_SIDED|95.0|-0.423|-0.043||Threshold for significance at 0.05 level.|MMRM|||||-0.043|-0.423|0.0167
72351958|NCT03201419|144223318|SUPERIORITY||Mean Difference|-0.208||||0.0352|TWO_SIDED|95.0|-0.401|-0.015||Threshold for significance at 0.05 level.|MMRM|||||-0.015|-0.401|0.0352
72351959|NCT03201419|144223318|SUPERIORITY||Mean Difference|-0.057||||0.6402|TWO_SIDED|95.0|-0.295|0.182||Threshold for significance at 0.05 level.|MMRM|||||0.182|-0.295|0.6402
72351960|NCT03201419|144223318|SUPERIORITY||Mean Difference|-0.121||||0.3602|TWO_SIDED|95.0|-0.381|0.139||Threshold for significance at 0.05 level.|MMRM|||||0.139|-0.381|0.3602
72351961|NCT03201419|144223318|SUPERIORITY||Mean Difference|0.074||||0.4018|TWO_SIDED|95.0|-0.099|0.247||Threshold for significance at 0.05 level.|MMRM|||||0.247|-0.099|0.4018
72351962|NCT03201419|144223319|SUPERIORITY||Mean Difference|-0.133||||0.1354|TWO_SIDED|95.0|-0.308|0.042||Threshold for significance at 0.05 level.|MMRM|||||0.042|-0.308|0.1354
72351963|NCT03201419|144223319|SUPERIORITY||Mean Difference|-0.091||||0.4238|TWO_SIDED|95.0|-0.315|0.133||Threshold for significance at 0.05 level.|MMRM|||||0.133|-0.315|0.4238
72351964|NCT03201419|144223319|SUPERIORITY||Mean Difference|-0.22||||0.0574|TWO_SIDED|95.0|-0.446|0.007||Threshold for significance at 0.05 level.|MMRM|||||0.007|-0.446|0.0574
72351965|NCT03201419|144223319|SUPERIORITY||Mean Difference|0.058||||0.6579|TWO_SIDED|95.0|-0.199|0.315||Threshold for significance at 0.05 level.|MMRM|||||0.315|-0.199|0.6579
72351966|NCT03201419|144223319|SUPERIORITY||Mean Difference|-0.17||||0.2337|TWO_SIDED|95.0|-0.45|0.11||Threshold for significance at 0.05 level.|MMRM|||||0.110|-0.450|0.2337
72351967|NCT03201419|144223319|SUPERIORITY||Mean Difference|-0.136||||0.1639|TWO_SIDED|95.0|-0.328|0.056||Threshold for significance at 0.05 level.|MMRM|||||0.056|-0.328|0.1639
72351968|NCT03201419|144223320|SUPERIORITY||Mean Difference|-87.2||||0.047|TWO_SIDED|95.0|-173.2|-1.2|||MMRM|||||-1.2|-173.2|0.0470
72351969|NCT03201419|144223320|SUPERIORITY||Mean Difference|-130.2||||0.0237|TWO_SIDED|95.0|-242.9|-17.6|||MMRM|||||-17.6|-242.9|0.0237
72351970|NCT03201419|144223320|SUPERIORITY||Mean Difference|-110.8||||0.0569|TWO_SIDED|95.0|-224.9|3.3|||MMRM|||||3.3|-224.9|0.0569
72351971|NCT03201419|144223320|SUPERIORITY||Mean Difference|-23.9||||0.7383|TWO_SIDED|95.0|-164.8|117.0|||MMRM|||||117.0|-164.8|0.7383
72351972|NCT03201419|144223320|SUPERIORITY||Mean Difference|-71.0||||0.3626|TWO_SIDED|95.0|-224.3|82.3|||MMRM|||||82.3|-224.3|0.3626
72351973|NCT03201419|144223320|SUPERIORITY||Mean Difference|23.4||||0.6524|TWO_SIDED|95.0|-78.9|125.7|||MMRM|||||125.7|-78.9|0.6524
72351974|NCT03201419|144223321|SUPERIORITY||Mean Difference|-49.5||||0.3273|TWO_SIDED|95.0|-148.9|49.9||Threshold for significance at 0.05 level.|MMRM|||||49.9|-148.9|0.3273
72351975|NCT03201419|144223321|SUPERIORITY||Mean Difference|-74.6||||0.25|TWO_SIDED|95.0|-202.0|52.9||Threshold for significance at 0.05 level.|MMRM|||||52.9|-202.0|0.2500
72351976|NCT03201419|144223321|SUPERIORITY||Mean Difference|-93.5||||0.1537|TWO_SIDED|95.0|-222.3|35.2||Threshold for significance at 0.05 level.|MMRM|||||35.2|-222.3|0.1537
72351977|NCT03201419|144223321|SUPERIORITY||Mean Difference|33.6||||0.6515|TWO_SIDED|95.0|-113.1|180.3||Threshold for significance at 0.05 level.|MMRM|||||180.3|-113.1|0.6515
72351978|NCT03201419|144223321|SUPERIORITY||Mean Difference|-75.7||||0.3506|TWO_SIDED|95.0|-235.3|83.9||Threshold for significance at 0.05 level.|MMRM|||||83.9|-235.3|0.3506
72351979|NCT03201419|144223321|SUPERIORITY||Mean Difference|-85.4||||0.1255|TWO_SIDED|95.0|-194.8|24.1||Threshold for significance at 0.05 level.|MMRM|||||24.1|-194.8|0.1255
72351980|NCT03838978|144223322|SUPERIORITY|Non-inferiority is demonstrated if the 90% LB \> -10.0%. If non-inferiority was met, superiority could be tested. Superiority is demonstrated if 97.5% LB \> 0.0%.||||||||||||||||For missing data in both Arms/Groups, multiple imputation was performed for the primary CCS analysis.|Device group differences and two-sided 90% and 97.5% confidence interval lower bounds (LB) adjusting for propensity score (PS) subclass based on PS subclass weights (ATT). Noninferiority is demonstrated if the 90% LB \> -10.0%. Superiority is demonstrated if 97.5% LB \>0.0%. Two-sided 97.5% LB is evaluated rather than two-sided 95.0% LB since the superiority type 1 error is split between testing superiority in terms of Month 24 CCS and then separately for a set of superiority secondary endpoints with type 1 error control maintained through the use of Hochberg approach (following demonstration of non-inferiority).|||
72351981|NCT02777827|144223364|SUPERIORITY||Least square mean|0.2221|STANDARD_ERROR_OF_MEAN|0.0453|<|0.0001|TWO_SIDED|95.0|0.1324|0.3118|||ANCOVA|||||0.3118|0.1324|<0.0001
72351982|NCT02777827|144223364|SUPERIORITY||Least Square Mean|0.4042|STANDARD_ERROR_OF_MEAN|0.0453|<|0.0001|TWO_SIDED|95.0|0.3146|0.4938|||ANCOVA|||||0.4938|0.3146|<0.0001
72351983|NCT02777827|144223364|SUPERIORITY||Least Square Mean|0.1056|STANDARD_ERROR_OF_MEAN|0.0451||0.0207|TWO_SIDED|95.0|0.0164|0.1949|||ANCOVA|||||0.1949|0.0164|0.0207
72351984|NCT02777827|144223364|SUPERIORITY||Least Square Mean|0.1701|STANDARD_ERROR_OF_MEAN|0.045||0.0002|TWO_SIDED|95.0|0.081|0.2592|||ANCOVA|||||0.2592|0.0810|0.0002
72351985|NCT02777827|144223364|SUPERIORITY||Least Square Mean|0.4062|STANDARD_ERROR_OF_MEAN|0.0451|<|0.0001|TWO_SIDED|95.0|0.317|0.4955|||ANCOVA|||||0.4955|0.3170|<0.0001
72351986|NCT02707146|144223407|SUPERIORITY||Odds Ratio (OR)|1.0|||||TWO_SIDED|95.0|||||Chi-squared|||||||
72351987|NCT01588561|144223431|OTHER||||||||||||||||||Increased signal: Insula, Putamen, Cingulate, Paracingulate, Calcarine cortex, Lingual gyrus, Frontal pole, Fusiform gyrus, Cerebellum. Decreased signal:Thalamus, Temporal gyri, Hippocampus (left), Caudate, Cerebellum|||
72351988|NCT01588561|144223432|OTHER||||||||||||||||||Increased signal: Insula, Putamen, Pallidum, Cingulate, Thalamus, Operculum, OBF cortex, Lingual gyrus, Cerebellum. Decreased signal: Hippocampus (left), Parahippocampus (left), Caudate, Cerebellum|||
72351989|NCT01588561|144223433|OTHER||||||||||||||||||Increased signal: Insula (bilateral), Cingulate, Pretcentralgyrus, Thalamus (bilateral), Putamen (bilateral), Pallidum (bilateral), Amygdala (bilateral), Ventral tegmental area, Accumbens Nuclei. Decreased signal: Insula (left inferior), OBF cortex, Frontal\&Temporal poles, Hippocampus (bilateral), Parahippocampus (bilateral), Accumbens nuclei, Cerebellum|||
72351990|NCT01818596|144223438|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|30 participants with evaluable aGFR (measured by iohexol clearance) in either cohort would provide at least 90% power to show that aGFR change is \< 20% after participants were administered E/C/F/TAF. In this sample size/power computation, it was assumed that the intra-participant variation for aGFR is 0.17 mL/min on natural logarithm scale and a clinical meaningful boundary in aGFR change is 80% to 125%.|Difference in GLSM Ratio|98.94|||||TWO_SIDED|90.0|93.71|104.46|||||A parametric analysis of variance model using a mixed-effects model with repeated statement was fitted to the natural logarithm transferred aGFR obtained at postbaseline visits and baseline.|Comparison is made between the baseline value and the value from the Week 2, 4, or 8 visit and presented as a geometric least squares mean (GLSM) ratio with 90% confidence interval (CI). Postbaseline value and baseline value were used as test and reference, respectively.||104.46|93.71|
72351991|NCT01818596|144223438|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|30 participants with evaluable aGFR (measured by iohexol clearance) in either cohort would provide at least 90% power to show that aGFR change is \< 20% after participants were administered E/C/F/TAF. In this sample size/power computation, it was assumed that the intra-participant variation for aGFR is 0.17 mL/min on natural logarithm scale and a clinical meaningful boundary in aGFR change is 80% to 125%.|Difference in GLSM Ratio|102.66|||||TWO_SIDED|90.0|97.11|108.53|||||A parametric analysis of variance model using a mixed-effects model with repeated statement was fitted to the natural logarithm transferred aGFR obtained at postbaseline visits and baseline.|Comparison is made between the baseline value and the value from the Week 24 visit and presented as a GLSM ratio with 90% CI. Week 24 value and baseline value were used as test and reference, respectively.||108.53|97.11|
72351992|NCT03801174|144223456|SUPERIORITY||Mean Difference (Net)|-0.23|STANDARD_ERROR_OF_MEAN|0.92||0.804|TWO_SIDED|95.0|-2.0|1.6|||Mixed Models Analysis|||||1.6|-2.0|.804
72351993|NCT03801174|144223457|SUPERIORITY||Mean Difference (Net)|50.2|STANDARD_ERROR_OF_MEAN|93.0||0.59|TWO_SIDED|95.0|-132.0|233.0|||Mixed Models Analysis|||||233|-132|.590
72351994|NCT03801174|144223458|SUPERIORITY||Mean Difference (Net)|806.0|STANDARD_ERROR_OF_MEAN|443.0||0.069|TWO_SIDED|95.0|-64.0|1675.0|||Mixed Models Analysis|||||1675|-64|.069
72351995|NCT01337336|144223472|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.3||||0.002||95.0|1.08|1.56|||Chi-squared||Estimated value obtained from logistic regression model controlling for differences between cohorts at baseline on demographic variables, proxy measures of COPD severity, and measures of overall disease burden.|||1.56|1.08|0.002
72351996|NCT01337336|144223473|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.56||||0.002||95.0|1.02|2.38||COPD-related hospitalization|Chi-squared||Estimated value obtained from logistic regression model controlling for differences between cohorts at baseline on demographic variables, proxy measures of COPD severity, and measures of overall disease burden.|||2.38|1.02|0.002
72351997|NCT01337336|144223473|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.65||||0.002||95.0|1.14|2.39||COPD-related ER visit|Chi-squared||Estimated value obtained from logistic regression model controlling for differences between cohorts at baseline on demographic variables, proxy measures of COPD severity, and measures of overall disease burden.|||2.39|1.14|0.002
72351998|NCT01337336|144223473|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.14||||0.503||95.0|0.93|1.4|||Chi-squared|COPD-related physician + Rx visit|Estimated value obtained from logistic regression model controlling for differences between cohorts at baseline on demographic variables, proxy measures of COPD severity, and measures of overall disease burden.|||1.40|0.93|0.503
72351999|NCT01337336|144223473|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.71|||<|0.001||95.0|1.26|2.31|||Chi-squared|COPD-related hospitalization/ER visit|Estimated value obtained from logistic regression model controlling for differences between cohorts at baseline on demographic variables, proxy measures of COPD severity, and measures of overall disease burden.|||2.31|1.26|<0.001
72352000|NCT01337336|144223475|SUPERIORITY_OR_OTHER||Incident Rate Ratio|1.46||||0.0004||95.0|1.01|2.09||COPD-related hospitalization|t-test, 2 sided||Estimated value obtained from zero-inflated negative binomial model controlling for differences between cohorts at baseline on demographic variables, proxy measures of COPD severity, and measures of overall disease burden.|||2.09|1.01|0.0004
72352001|NCT01337336|144223475|SUPERIORITY_OR_OTHER||Incident Rate Ratio|1.27||||0.208||95.0|0.89|1.82||COPD-related ER visit|t-test, 2 sided||Estimated value obtained from zero-inflated negative binomial model controlling for differences between cohorts at baseline on demographic variables, proxy measures of COPD severity, and measures of overall disease burden.|||1.82|0.89|0.208
72352002|NCT01337336|144223475|SUPERIORITY_OR_OTHER||Incident Rate Ratio|1.09||||0.671||95.0|0.9|1.32||COPD-related physician + Rx visit|t-test, 2 sided||Estimated value obtained from zero-inflated negative binomial model controlling for differences between cohorts at baseline on demographic variables, proxy measures of COPD severity, and measures of overall disease burden.|||1.32|0.90|0.671
72352003|NCT01337336|144223475|SUPERIORITY_OR_OTHER||Incident Rate Ratio|1.31||||0.009||95.0|1.05|1.72||COPD-related hospitalization/ER visit|t-test, 2 sided||Estimated value obtained from zero-inflated negative binomial model controlling for differences between cohorts at baseline on demographic variables, proxy measures of COPD severity, and measures of overall disease burden.|||1.72|1.05|0.009
72352004|NCT01337336|144223475|SUPERIORITY_OR_OTHER||Incident Rate Ratio|1.16||||0.052||95.0|0.98|1.37||COPD-related hospitalization/ER visit/physician + Rx visit|t-test, 2 sided||Estimated value obtained from zero-inflated negative binomial model controlling for differences between cohorts at baseline on demographic variables, proxy measures of COPD severity, and measures of overall disease burden.|||1.37|0.98|0.052
72352005|NCT01379183|144223496|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|||||||<0.0001
72352006|NCT01379183|144223497|SUPERIORITY_OR_OTHER|||||||0.27|||||||ANCOVA|||||||0.27
72352007|NCT01379183|144223498|SUPERIORITY_OR_OTHER|||||||0.96|||||||ANCOVA|||||||0.96
72352008|NCT01379183|144223499|SUPERIORITY_OR_OTHER|||||||0.71|||||||ANCOVA|||||||0.71
72352009|NCT01379183|144223500|SUPERIORITY_OR_OTHER|||||||0.37|||||||ANCOVA|||||||0.37
72352010|NCT01379183|144223501|SUPERIORITY_OR_OTHER|||||||0.12|||||||ANCOVA|||||||0.12
72352011|NCT01695135|144223505|SUPERIORITY||Hazard Ratio (HR)|0.528||||0.0002|TWO_SIDED|95.0|0.376|0.74|||Log Rank|||||0.740|0.376|0.0002
72352012|NCT02562716|144223513|SUPERIORITY|||||||0.15|||||||Log Rank|||For each arm, the observed 2-year overall survival (OS) was compared to the null hypothesis of 40%, assuming a 58% alternative hypothesis, 88% power, and a 1-sided significance of 0.05.||||.15
72352013|NCT02562716|144223513|SUPERIORITY|||||||0.14|||||||Log Rank|||For each arm, the observed 2-year overall survival (OS) was compared to the null hypothesis of 40%, assuming a 58% alternative hypothesis, 88% power, and a 1-sided significance of 0.05.||||.14
72352014|NCT01775371|144223527|SUPERIORITY||Mean Difference (Final Values)|1.0|||<|0.001|TWO_SIDED|95.0|0.6|1.5||The a priori threshold for statistical significance was 0.05.|Z-test 2-sided||The direction of the comparison is the Patient Controlled Analgesia minus the standard care group|The rate of change of NRS pain scores per hour was calculated using a mixed effects linear model. Time is represented as a linear spline with knot at 30 minutes to support the separate estimation of early and late phase rates of change. Fixed effects in the analysis includes study-group indicator, early and late phase time, and interactions between study-group and time. The principal hypothesis test was a z-test of the coefficient of the study group late phase interaction term.||1.5|0.6|<0.001
72352015|NCT01775371|144223528|SUPERIORITY|||||||0.025|||||||Chi-squared|||||||0.025
72352016|NCT01775371|144223529|SUPERIORITY|||||||0.003|||||||Chi-squared|||||||0.003
72352017|NCT01775371|144223530|OTHER|Responses occur with equal probability|||||<|0.001|||||||Chi-squared|One-sample chi-squared test of hypothesis that the responses occur with equal probability||These outcomes are based on the nurses who took care of patients in the study||||<0.001
72352018|NCT01775371|144223531|OTHER|All responses occur with equal probability|||||<|0.001|||||||Chi-squared|One-sample chi-squared test of hypothesis that the responses occur with equal probability||This outcome is based on the physicians who took care of the patients in the study||||<0.001
72352019|NCT01425801|144223554|SUPERIORITY_OR_OTHER||Least Squares Mean DIfference|0.405|STANDARD_ERROR_OF_MEAN|0.027|<|0.0001|TWO_SIDED|95.0|0.353|0.458|||ANCOVA|Sequence, treatment and period as fixed effect factors, patient within sequence as random effect and baseline peak FEV1 at each period as a covariate||||0.458|0.353|<0.0001
72352020|NCT01425801|144223554|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.371|STANDARD_ERROR_OF_MEAN|0.027|<|0.0001|TWO_SIDED|95.0|0.318|0.424|||ANCOVA|Sequence, treatment and period as fixed effect factors, patient within sequence as random effect and baseline peak FEV1 at each period as a covariate||||0.424|0.318|<0.0001
72352021|NCT01425801|144223554|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.322|STANDARD_ERROR_OF_MEAN|0.027|<|0.0001|TWO_SIDED|95.0|0.269|0.375|||ANCOVA|Sequence, treatment and period as fixed effect factors, patient within sequence as random effect and baseline peak FEV1 at each period as a covariate||||0.375|0.269|<0.0001
72352022|NCT01425801|144223554|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.274|STANDARD_ERROR_OF_MEAN|0.027|<|0.0001|TWO_SIDED|95.0|0.221|0.327|||ANCOVA|Sequence, treatment and period as fixed effect factors, patient within sequence as random effect and baseline peak FEV1 at each period as a covariate||||0.327|0.221|<0.0001
72352023|NCT02868554|144223572|SUPERIORITY||Mean Difference (Final Values)|0.05||||0.07|TWO_SIDED||||||ANOVA|||||||0.07
72352024|NCT02868554|144223573|SUPERIORITY||Mean Difference (Final Values)|0.05||||0.02|TWO_SIDED||||||ANOVA|||||||0.02
72352025|NCT02714569|144223588|NON_INFERIORITY|Analyses were based on a pre-defined non-inferiority margin|Least Square Means Percentage|204.8|||||TWO_SIDED|90.0|161.9|259.0|||||Analysis was the estimate of the ratio fasted versus fed.|Geometric Mean Fed/Fasted Ratio of LY3202328 Cmax at 30 mg||259.0|161.9|
72352026|NCT02714569|144223590|NON_INFERIORITY|Analyses were based on a pre-defined non-inferiority margin|Least Squares Mean Percentage|193.3|||||TWO_SIDED|90.0|144.7|258.2||||||Geometric Mean Fed/Fasted Ratio of LY3202328 AUC(0-inf) at 30 mg||258.2|144.7|
72352027|NCT02714569|144223602|OTHER|Ratio estimate without hypothesis testing|Geometric Least Square Means Ratio (%)|141.0|||||TWO_SIDED|90.0|67.9|293.0||||||Part B Placebo||293.0|67.9|
72352028|NCT02714569|144223602|OTHER|Ratio estimate without hypothesis testing|Geometric Least Square Means Ratio (%)|70.8|||||TWO_SIDED|90.0|31.9|157.1||||||Part B 5 mg LY||157.1|31.9|
72352029|NCT02714569|144223602|OTHER|Ratio estimate without hypothesis testing|Geometric Least Square Means Ratio (%)|109.2|||||TWO_SIDED|90.0|99.8|119.5||||||Part B 20 mg LY||119.5|99.8|
72352030|NCT02714569|144223602|OTHER|Ratio estimate without hypothesis testing|Geometric Least Square Means Ratio (%)|107.7|||||TWO_SIDED|90.0|68.1|170.4||||||Part B 100 mg LY||170.4|68.1|
72352031|NCT02714569|144223602|OTHER|Ratio estimate without hypothesis testing|Geometric Least Squares Mean Ratio (%)|213.3|||||TWO_SIDED|90.0|200.3|227.1||||||Part B 300 mg LY||227.1|200.3|
72352032|NCT02714569|144223602|OTHER|Ratio estimate without hypothesis testing|Geometric Least Square Means Ratio (%)|115.4|||||TWO_SIDED|90.0|91.2|146.2||||||Part B Overall||146.2|91.2|
72352033|NCT02714569|144223603|OTHER|Ratio estimate without hypothesis testing|Geometric Least Squares Mean Ratio (%)|155.0|||||TWO_SIDED|90.0|87.6|274.2||||||Part B Placebo||274.2|87.6|
72352034|NCT02714569|144223603|OTHER|Ratio estimate without hypothesis testing|Geometric Least Squares Mean Ratio (%)|71.5|||||TWO_SIDED|90.0|40.7|125.3||||||Part B 5 mg LY||125.3|40.7|
72352035|NCT02714569|144223603|OTHER|Ratio estimate without hypothesis testing|Geometric Least Squares Mean Ratios (%)|122.4|||||TWO_SIDED|90.0|90.7|165.1||||||Part B 20 mg LY||165.1|90.7|
72352036|NCT02714569|144223603|OTHER|Ratio estimate without hypothesis testing|Geometric Least Squares Mean Ratio (%)|136.6|||||TWO_SIDED|90.0|89.8|207.7||||||Part B 100 mg LY||207.7|89.8|
72352037|NCT02714569|144223603|OTHER|Ratio estimate without hypothesis testing|Geometric Least Squares Mean Ratio (%)|132.6|||||TWO_SIDED|90.0|90.5|194.4||||||Part B 300 mg LY||194.4|90.5|
72352038|NCT02714569|144223603|OTHER|Ratio estimate without hypothesis|Geometric Least Squares Mean Ratio (%)|112.2|||||TWO_SIDED|90.0|93.2|135.1||||||Part B Overall||135.1|93.2|
72352039|NCT02714569|144223604|OTHER|Ratio estimate without hypothesis testing|Geometric Least Squares Mean Ratio (%)|97.3|||||TWO_SIDED|90.0|80.4|117.8||||||Part B Placebo||117.8|80.4|
72352040|NCT02714569|144223604|OTHER|Ratio estimate without hypothesis testing|Geometric Least Squares Mean Ratio (%)|57.5|||||TWO_SIDED|90.0|31.3|106.0||||||||106.0|31.3|
72352041|NCT02714569|144223604|OTHER|Ratio estimate without hypothesis testing|Geometric Least Squares Mean Ratio (%)|96.2|||||TWO_SIDED|90.0|66.8|138.7||||||Part B 20 mg LY||138.7|66.8|
72352042|NCT02714569|144223604|OTHER|Ratio estimate without hypothesis testing|Geometric Least Squares Mean Ratio (%)|80.9|||||TWO_SIDED|90.0|45.8|142.7||||||Part B 100 mg LY||142.7|45.8|
72352043|NCT02714569|144223604|OTHER|Ratio estimate without hypothesis testing|Geometric Least Squares Mean Ratio (%)|108.2|||||TWO_SIDED|90.0|40.2|291.2||||||Part B 300 mg LY||291.2|40.2|
72352044|NCT02714569|144223604|OTHER|Ratio estimate without hypothesis|Geometric Least Squares Mean Ratio (%)|87.9|||||TWO_SIDED|90.0|67.4|114.7||||||Part B Overall||114.7|67.4|
72352045|NCT02714569|144223605|OTHER|Ratio estimate without hypothesis testing|Geometric Least Square Means Ratio (%)|96.0|||||TWO_SIDED|90.0|90.2|102.1||||||Part B Placebo||102.1|90.2|
72352046|NCT02714569|144223605|OTHER|Ratio estimate without hypothesis testing|Geometric Least Squares Mean Ratio (%)|90.7|||||TWO_SIDED|90.0|59.8|137.6||||||Part B 5 mg LY||137.6|59.8|
72352047|NCT02714569|144223605|OTHER|Ratio estimate without hypothesis testing|Geometric Least Square Means Ratio (%)|99.9|||||TWO_SIDED|90.0|75.9|131.5||||||Part B 20 mg LY||131.5|75.9|
72352048|NCT02714569|144223605|OTHER|Ratio estimate without hypothesis testing|Geometric Least Square Means Ratio (%)|91.0|||||TWO_SIDED|90.0|67.5|122.7||||||Part B 100 mg LY||122.7|67.5|
72352049|NCT02714569|144223605|OTHER|Ratio estimate without hypothesis testing|Geometric Least Squares Mean Ratio (%)|87.0|||||TWO_SIDED|90.0|42.0|180.5||||||Part B 300 mg LY||180.5|42.0|
72352050|NCT02714569|144223605|OTHER|Ratio estimate without hypothesis|Geometric Least Squares Mean Ratio (%)|93.5|||||TWO_SIDED|90.0|81.8|106.9||||||Part B Overall||106.9|81.8|
72352051|NCT04915729|144223606|NON_INFERIORITY|pre-specified non-inferiority margin for risk ratio = 0.937|Risk Ratio (RR)|1.0278|||||TWO_SIDED|95.0|0.9678|1.0915|||Modified Possion Regression Model|treatment = main effect; baseline NHISS, age + time to drug administration since stroke symptoms onset = continuous covariates|tenecteplase versus alteplase|||1.0915|0.9678|
72352052|NCT04915729|144223607|OTHER|log-binomial regression model|Risk Ratio (RR)|1.0671||||0.2412|TWO_SIDED|95.0|0.9573|1.1895||p-value was for superiority testing|Regression, Linear|treatment = main effect; baseline NHISS, age + time to drug administration since stroke symptoms onset = covariates|tenecteplase versus alteplase|||1.1895|0.9573|0.2412
72352053|NCT04915729|144223608|OTHER|Modified Poisson regression model|Risk Ratio (RR)|1.0078||||0.748|TWO_SIDED|95.0|0.9614|1.0564||p-value was for superiority testing|Regression, Linear|treatment = main effect; baseline NHISS, age + time to drug administration since stroke symptoms onset = continuous covariates|tenecteplase versus alteplase|||1.0564|0.9614|0.7480
72352054|NCT04915729|144223609|OTHER||Mean Difference (Final Values)|-0.45|STANDARD_ERROR_OF_MEAN|0.48||0.3511|TWO_SIDED|95.0|-1.4|0.5|||Mixed Models Analysis|baseline NIHSS, age, time to administration since stroke symptoms onset = linear covariates; treatment = fixed effects|Difference in LSmean tenecteplase vs alteplase|||0.50|-1.40|0.3511
72352055|NCT04915729|144223610|OTHER||Odds Ratio (OR)|1.0418||||0.4806|||||||Regression, Logistic|Assumption-free ordinal analysis|tenecteplase versus alteplase|||||0.4806
72352056|NCT04915729|144223611|OTHER|Poisson regression model|Risk Ratio (RR)|1.0189||||0.5116|TWO_SIDED|95.0|0.9635|1.0774|||Regression, Linear|treatment = main effect; baseline NHISS, age + time to drug administration since stroke symptoms onset = covariates|tenecteplase versus alteplase|||1.0774|0.9635|0.5116
72352057|NCT04915729|144223612|OTHER||Risk Ratio (RR)|1.005||||1|TWO_SIDED|95.0|0.37|2.701|||Suissa-Shuster test||tenecteplase versus alteplase|||2.701|0.370|1.000
72352058|NCT04915729|144223613|OTHER||Risk Ratio (RR)|0.795||||0.303|TWO_SIDED|95.0|0.513|1.232|||Chi-squared||tenecteplase versus alteplase|||1.232|0.513|0.303
72352059|NCT04915729|144223614|OTHER|Modified Poisson regression model|Risk Ratio (RR)|0.9215||||0.6345|TWO_SIDED|95.0|0.6578|1.2908||p-value was for superiority testing|Regression, Linear|treatment = main effect; baseline NHISS, age + time to drug administration since stroke symptoms onset = continuous covariates|tenecteplase versus alteplase|||1.2908|0.6578|0.6345
72352060|NCT00587678|144223625|SUPERIORITY_OR_OTHER|||||||0.32||95.0|||||Linear repeated measures model|||||||0.32
72352061|NCT00587678|144223625|SUPERIORITY_OR_OTHER||||||<|0.01||95.0||||vs. baseline|Linear repeated measures model|||||||<0.01
72352062|NCT00587678|144223626|SUPERIORITY_OR_OTHER|||||||0.31||95.0|||||Linear repeated measures model|||||||0.31
72352063|NCT00587678|144223626|SUPERIORITY_OR_OTHER||||||<|0.05||95.0||||vs. baseline|Linear repeated measures model|||||||<0.05
72352064|NCT00587678|144223627|SUPERIORITY_OR_OTHER|||||||0.71||95.0|||||Linear repeated measures model|||||||0.71
72352065|NCT00587678|144223628|SUPERIORITY_OR_OTHER|||||||0.67||95.0|||||Linear repeated measures model|||||||0.67
72352066|NCT00587678|144223629|SUPERIORITY_OR_OTHER|||||||0.37||95.0|||||Linear repeated measures model|||||||0.37
72352067|NCT00587678|144223629|SUPERIORITY_OR_OTHER||||||<|0.05||95.0||||vs. baseline|Linear repeated measures model|||||||<0.05
72352068|NCT00587678|144223630|SUPERIORITY_OR_OTHER|||||||0.78||95.0|||||Linear repeated measures model|||||||0.78
72352069|NCT00587678|144223631|SUPERIORITY_OR_OTHER|||||||0.68||95.0|||||Linear repeated measures model|||||||0.68
72352070|NCT00587678|144223632|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Linear repeated measures model|||||||<0.05
72352071|NCT00587678|144223633|SUPERIORITY_OR_OTHER||||||=|0.67||95.0|||||linear repeated measures model|||||||=0.67
72352072|NCT00587678|144223634|SUPERIORITY_OR_OTHER|||||||0.77||95.0|||||Linear repeated measures model|||||||0.77
72352073|NCT00587678|144223635|SUPERIORITY_OR_OTHER|||||||0.85||95.0|||||Linear repeated measures model|||||||0.85
72352074|NCT03710642|144223636|SUPERIORITY||Mean Difference (Net)|-0.008096||||0.9904|TWO_SIDED||||||Regression, Linear|||||||0.9904
72352075|NCT03710642|144223637|SUPERIORITY||Mean Difference (Net)|-11.54||||0.30328|TWO_SIDED||||||Regression, Linear|||||||0.30328
72352076|NCT03710642|144223638|SUPERIORITY||Mean Difference (Net)|0.31122||||0.21981|TWO_SIDED||||||Regression, Linear|||||||0.21981
72352077|NCT03710642|144223639|SUPERIORITY||Cox Proportional Hazard|-0.36277||||0.6366|TWO_SIDED||||||Regression, Cox|||||||0.6366
72352078|NCT03710642|144223640|SUPERIORITY||Slope|-0.12842|STANDARD_ERROR_OF_MEAN|1.39602||0.9267|TWO_SIDED||||||Regression, Logistic|||||||0.9267
72352079|NCT03710642|144223641|SUPERIORITY||Mean Difference (Net)|3.0694||||0.2038|TWO_SIDED||||||Regression, Linear|||||||0.2038
72352080|NCT03710642|144223642|SUPERIORITY||Mean Difference (Net)|-3.388||||0.54133|TWO_SIDED||||||Regression, Linear|||||||0.54133
72352081|NCT05282927|144223646|SUPERIORITY||Mean Difference (Net)|-0.05||||0.92|TWO_SIDED|95.0|-1.07|0.98|||Regression, Linear|||Models included the arm indicator variable in addition to the stratification variables used in randomization: site complexity level (high complexity '1a', '1b' or '1c' vs. all others) and rurality (high sites serving ≥50% rural/highly rural Veterans vs. low sites serving \<50% rural/highly rural Veterans)||0.98|-1.07|0.92
72352082|NCT05282927|144223647|SUPERIORITY||Mean Difference (Net)|0.94||||0.056|TWO_SIDED|95.0|-0.03|1.9|||Regression, Linear|||Models included the arm indicator variable in addition to the stratification variables used in randomization: site complexity level (high complexity '1a', '1b' or '1c' vs. all others) and rurality (high sites serving ≥50% rural/highly rural Veterans vs. low sites serving \<50% rural/highly rural Veterans).||1.90|-0.03|0.056
72352083|NCT02538042|144223671|SUPERIORITY|||||||0.39|||||||ANOVA|||||||0.39
72352084|NCT00731679|144223689|SUPERIORITY_OR_OTHER_LEGACY|||||||0.01|||||||Regression, Logistic|The p-value was obtained from a logistic regression model with fixed effects for treatment arm and analysis center.||||||0.01
72352085|NCT00731679|144223690|SUPERIORITY_OR_OTHER_LEGACY|||||||0.005|||||||Regression, Logistic|The p-value was obtained from a logistic regression model with fixed effects for treatment arm and analysis center.||||||0.005
72352086|NCT01598922|144223691|OTHER|Intent-to-treat (ITT) analyses following multiple imputation. Generalized Linear Models (GENLIN) predicting post-treatment HRSD scores in the imputed dataset. Covarying for pre-treatment HRSD scores, age and sex.|Odds Ratio (OR)|6.11|STANDARD_ERROR_OF_MEAN|1.68|<|0.0001|TWO_SIDED|95.0|2.814|9.403|||GENLIN|||||9.403|2.814|<0.0001
72352087|NCT01598922|144223692|OTHER||Cohen's d measure of effect size|-0.79||||0.024|TWO_SIDED|95.0|-1.25|-0.32||Hierarchical Linear Modeling (HLM) was applied to PHQ-9 data, adjusting for baseline PHQ-9 score. Group x Time interactions tested for between-group differences in slope of improvement of PHQ-9 scores.|hierarchical linear modeling|Age and sex were covariates. Cohen's d effect sizes are reported.||||-0.32|-1.25|.024
72352088|NCT01598922|144223693|OTHER|Hierarchical Linear Modeling (HLM) was applied to K-10 data, adjusting for baseline K-10 score. Group x Time interactions tested for between-group differences in slope of improvement of K-10 scores.|Cohen's d measure of effect size|-0.95||||0.003|TWO_SIDED|95.0|-1.42|-0.48|||HLM|||The Kessler Psychological Distress Scale (K-10) is a 10-item scale with total scores that can range from 0 to 50. Higher scores represent worse (more severe) psychological distress.||-0.48|-1.42|.003
72352089|NCT02052752|144223786|SUPERIORITY_OR_OTHER|||||||0.283||95.0|||||ANCOVA|||The ANCOVA results for the primary endpoint with treatment group as a main effect and average baseline value as a covariate showed no statistically significant differences in the percentage change from baseline in swelling of the target lesions between the 3% BPO group and the vehicle control group at Day 4 for the ITT population||||0.283
72352090|NCT00369577|144223797|SUPERIORITY|||||||0.088||||||p-values (adjusted) using Dunnett's t-test in main effects ANCOVA model|ANCOVA|||||||0.0880
72352091|NCT00369577|144223797|SUPERIORITY|||||||0.0002||||||p-values (adjusted) using Dunnett's t-test in main effects ANCOVA model|ANCOVA|||||||0.0002
72352092|NCT00369577|144223798|SUPERIORITY|||||||0.0583|||||||Wilcoxon (Mann-Whitney)|||||||0.0583
72352093|NCT00369577|144223798|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||< 0.0001
72352094|NCT00369577|144223799|SUPERIORITY|||||||0.0067|||||||Wilcoxon (Mann-Whitney)|||||||0.0067
72352095|NCT00369577|144223799|SUPERIORITY|||||||0.0003|||||||Wilcoxon (Mann-Whitney)|||||||0.0003
72352096|NCT00369577|144223800|SUPERIORITY|||||||0.0076|||||||Fisher Exact|||||||0.0076
72352097|NCT00369577|144223800|SUPERIORITY|||||||0.0001|||||||Fisher Exact|||||||0.0001
72369498|NCT02039843|144249195|SUPERIORITY|||||||0.052||||||Two-sided a priori alpha level was 0.05.|Mixed Models Analysis|Linear mixed repeated measures analysis on group difference in WHO-DAS score adjusted for gender, site, baseline score, time \& timeXgroup interaction||||||0.052
72369499|NCT02039843|144249196|SUPERIORITY|||||||0.421||||||2-sided a priori alpha level was 0.05|Mixed Models Analysis|Linear mixed repeated measures analysis on group difference in PCS score adjusted for gender, site, baseline score, time, and timeXgroup||||||0.421
72352098|NCT01059318|144223821|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|76.0|||||TWO_SIDED|95.0|-45.0|196.0|||Bayesian analysis|A Bayesian posterior distribution of the treatment effect at 26 weeks was evaluated using a non-informative prior.|MILES study and current study had different study designs, so change from baseline to 26 weeks in MILES study was estimated from the publicly reported rate of change per month in order to provide a meaningful comparison based on Bayesian analysis.|"Proof of Concept was proposed as follows:~* 90% level of proof that difference in FVC change from baseline everolimus vs. Historical Placebo Control arm from MILES study \> 0 mL~* 50% level of proof that difference in FVC change from baseline everolimus vs. Historical Placebo Control arm from MILES study \>= 100 mL~Historical data from 43 patients treated with placebo from the MILES study were down weighted to an effective sample size of 18 for comparison."||196|-45|
72352099|NCT01059318|144223822|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|186.0|||||TWO_SIDED|95.0|93.0|279.0|||Bayesian analysis|A Bayesian posterior distribution of the treatment effect at 26 weeks was evaluated using a non-informative prior.|MILES study and current study had different study designs, so change from baseline to 26 weeks in MILES study was estimated from the publicly reported rate of change per month in order to provide a meaningful comparison based on Bayesian analysis.|"Proof of Concept was proposed as follows:~* 90% level of proof that difference in FEV1 change from baseline everolimus vs. Historical Placebo Control arm from MILES study \> 0 mL~* 50% level of proof that difference in FEV1 change from baseline everolimus vs. Historical Placebo Control arm from MILES study \>= 100 mL~Historical data from 43 patients treated with placebo from the MILES study were down weighted to an effective sample size of 18 for comparison."||279|93|
72352100|NCT01604291|144223836|OTHER|||||||0.9109||||||The p-value from chi-square is the difference between SVR achieved (yes/no) and dose modifications.|Chi-squared|||Correlation between SVR 24 and Gender||||0.9109
72352101|NCT01604291|144223836|OTHER|||||||0.1163||||||A t-test was done to compare SVR participants to non-SVR.|t-test, 1 sided|||Correlation between SVR 24 and Age||||0.1163
72352102|NCT01604291|144223836|OTHER|||||||0.9269||||||A t-test was done to compare SVR participants to non-SVR.|t-test, 1 sided|||Correlation between SVR 24 and Height||||0.9269
72352103|NCT01604291|144223836|OTHER|||||||0.3376||||||A t-test was done to compare SVR participants to non-SVR.|t-test, 1 sided|||Correlation between SVR 24 and Weight||||0.3376
72352104|NCT01604291|144223836|OTHER|||||||0.4618||||||A t-test was done to compare SVR participants to non-SVR.|t-test, 1 sided|||Correlation between SVR 24 and Body mass index.||||0.4618
72352105|NCT01604291|144223849|OTHER||phi-coefficient|-0.0835||||0.0463|||||||Chi-squared|The p-value from chi-square is the difference between SVR achieved (yes/no) and dose modifications.|phi-coefficient is a measure of the degree of association between two binary variables|Correlation with dose modification for Peginterferon alfa-2a.||||0.0463
72352106|NCT01604291|144223849|OTHER||phi-coefficient|0.0666||||0.2052|||||||Chi-squared|The p-value from chi-square is the difference between SVR achieved (yes/no) and dose modifications.|phi-coefficient is a measure of the degree of association between two binary variables.|Correlation with dose modification for Ribavirin.||||0.2052
72352107|NCT01604291|144223849|OTHER||phi-coefficient|-0.1672||||0.0033|||||||Fisher Exact|The p-value from chi-square is the difference between SVR achieved (yes/no) and dose modifications.|phi-coefficient is a measure of the degree of association between two binary variables.|Correlation with dose modification for Telaprevir/boceprevir.||||0.0033
72352108|NCT01657292|144223851|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||1-sided, significance level = 0.025|Binomial test|||"All patients received both treatments and treatments were intra-individually compared.~Hypotheses tested: H0: s0 ≤0.5 and H1: s0 \>0.5 (with s0=rate of superiority of Oleogel-S10)."||||<0.0001
72352109|NCT00650845|144223862|NON_INFERIORITY_OR_EQUIVALENCE|Assuming that in both MRI groups approximately 12% of the patients would have an increase in serum creatinine of at least 25% with respect to baseline values after imaging procedures, 120 evaluable patients (2 x 60) were needed to ensure with 80% power, at 5% one-sided significance level, that the difference between the two MRI procedures was less than 15% which was the non-inferiority clinical limit of the difference established for this study.|Mean Difference (Final Values)|-1.4|||||TWO_SIDED|95.0|-7.9|6.7||||||The clinical non-inferiority limit of (non-enhanced - Dotarem®-enhanced) was fixed at -15%. The exact 95%Confidence Interval (CI) of the difference (non-enhanced - Dotarem®-enhanced) was \[-7.9%; +6.7%\]||6.7|-7.9|
72352110|NCT00650845|144223863|SUPERIORITY_OR_OTHER|||||||0.291|TWO_SIDED|||||p-value for main effect (difference between groups) adjusted on centers.|t-test, 2 sided|||Serum creatinine level fluctuation in terms of difference between baseline and 72 ±24hours after imaging procedure values was computed for both MRI procedures and compared between the 2 groups. A linear regression model was used to model the serum creatinine changes from baseline as a function of the MRI procedure with adjustment on centers.||||0.291
72352111|NCT00650845|144223864|NON_INFERIORITY_OR_EQUIVALENCE|Assuming that in both MRI groups approximately 12% of the patients would have an increase in serum creatinine of at least 25% with respect to baseline values after imaging procedures, 120 evaluable patients (2 x 60) were needed to ensure with 80% power, at 5% one-sided significance level, that the difference between the two MRI procedures was less than 15% which was the non-inferiority clinical limit of the difference established for this study.|Mean Difference (Final Values)|-2.7|||||TWO_SIDED|95.0|-14.1|8.9||||||The clinical non-inferiority limit of (non-enhanced - Dotarem®-enhanced) was fixed at -15%. The exact 95%CI of the difference (non-enhanced - Dotarem®-enhanced) was \[-14.1%; +8.9%\]||8.9|-14.1|
72352112|NCT00650845|144223865|SUPERIORITY_OR_OTHER|||||||0.04|TWO_SIDED|||||p-value for main effect (difference between groups) adjusted on centers.|t-test, 2 sided|||Serum creatinine level fluctuation in terms of difference between baseline and 72 ±24hours after imaging procedure values was computed for both MRI procedures and compared between the 2 groups. A linear regression model was used to model the serum creatinine changes from baseline as a function of the MRI procedure with adjustment on centers.||||0.040
72369500|NCT02039843|144249197|SUPERIORITY|||||||0.606||||||2-sided a priori alpha level was 0.05|Mixed Models Analysis|Linear mixed repeated measures analysis on group difference in MCS score adjusted for gender, site, baseline score, time, and timeXgroup||||||0.606
72369501|NCT02039843|144249198|SUPERIORITY|||||||0.21||||||2-sided a priori alpha level was 0.05|Mixed Models Analysis|Linear mixed repeated measures analysis on group difference in PSQI score adjusted for gender, site, baseline score, time, and timeXgroup||||||0.210
72352113|NCT00650845|144223866|SUPERIORITY_OR_OTHER|||||||0.301|TWO_SIDED|||||p-value for main effect (difference between groups) adjusted on centers.|t-test, 2 sided|||eGFR fluctuation in terms of percentage and mean difference between baseline and 72 ±24hours after imaging procedure values was computed for both MRI procedures and compared between the 2 groups. A linear regression model was used to model the relative or absolute eGFR variation from baseline as a function of the MRI procedure with adjustment on centers.||||0.301
72352114|NCT00650845|144223867|SUPERIORITY_OR_OTHER|||||||0.051|TWO_SIDED|||||p-value for main effect (difference between groups) adjusted on centers.|t-test, 2 sided|||eGFR fluctuation in terms of percentage and mean difference between baseline and 72 ±24hours after imaging procedure values was computed for both MRI procedures and compared between the 2 groups. A linear regression model was used to model the relative or absolute eGFR variation from baseline as a function of the MRI procedure with adjustment on centers.||||0.051
72352115|NCT04177212|144223916|OTHER||||||<|0.0001||||||P-value for testing null-hypothesis that response of Pooled Group was less or equal to 50 percent (%).|One-sided binomial test|||Between Groups calculation were not done because comparing Groups A and B was not part of the objective of this investigation.||||< 0.0001
72352116|NCT04177212|144223917|OTHER|||||||0.0003||||||P-value for testing null-hypothesis that response of Pooled Group was less or equal to 50%.|One-sided binomial test|||Between Groups calculation were not done because comparing Groups A and B was not part of the objective of this investigation.||||0.0003
72352117|NCT00857857|144223930|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.24|STANDARD_ERROR_OF_MEAN|0.1033|||TWO_SIDED|95.0|0.031|0.449||||||||0.449|0.031|
72352118|NCT00857857|144223930|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.265|STANDARD_ERROR_OF_MEAN|0.1048|||TWO_SIDED|95.0|0.053|0.477||||||||0.477|0.053|
72352119|NCT00857857|144223930|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.456|STANDARD_ERROR_OF_MEAN|0.0993|||TWO_SIDED|95.0|0.255|0.657||||||||0.657|0.255|
72352120|NCT00857857|144223930|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.526|STANDARD_ERROR_OF_MEAN|0.1025|||TWO_SIDED|95.0|0.319|0.733||||||||0.733|0.319|
72352121|NCT00857857|144223931|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.21|STANDARD_ERROR_OF_MEAN|0.0975|||TWO_SIDED|95.0|0.013|0.407||||||||0.407|0.013|
72352122|NCT00857857|144223931|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.154|STANDARD_ERROR_OF_MEAN|0.0988|||TWO_SIDED|95.0|-0.046|0.354||||||||0.354|-0.046|
72352123|NCT00857857|144223931|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.303|STANDARD_ERROR_OF_MEAN|0.0937|||TWO_SIDED|95.0|0.113|0.492||||||||0.492|0.113|
72352124|NCT00857857|144223931|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.404|STANDARD_ERROR_OF_MEAN|0.0966|||TWO_SIDED|95.0|0.209|0.599||||||||0.599|0.209|
72352125|NCT00857857|144223932|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.025|STANDARD_ERROR_OF_MEAN|0.1372|||TWO_SIDED|95.0|-0.302|0.253|||||Comparison of Minimum FEV1 between Placebo and GW870086 0.25 mg.|||0.253|-0.302|
72352126|NCT00857857|144223932|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.106|STANDARD_ERROR_OF_MEAN|0.1391|||TWO_SIDED|95.0|-0.176|0.387|||||Comparison of Minimum FEV1 between Placebo and GW870086 1 mg.|||0.387|-0.176|
72352127|NCT00857857|144223932|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.239|STANDARD_ERROR_OF_MEAN|0.1319|||TWO_SIDED|95.0|-0.028|0.506|||||Comparison of Minimum FEV1 between Placebo and GW870086 3 mg.|||0.506|-0.028|
72352128|NCT00857857|144223932|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.534|STANDARD_ERROR_OF_MEAN|0.1359|||TWO_SIDED|95.0|0.26|0.809|||||Comparison of Minimum FEV1 between Placebo and fluticasone propionate 0.25 mg BID.|||0.809|0.260|
72352129|NCT00857857|144223932|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.054|STANDARD_ERROR_OF_MEAN|0.0984|||TWO_SIDED|95.0|-0.145|0.253|||||Comparison of Weighted Mean FEV1 between Placebo and GW870086 0.25 mg.|||0.253|-0.145|
72352130|NCT00857857|144223932|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.026|STANDARD_ERROR_OF_MEAN|0.0998|||TWO_SIDED|95.0|-0.176|0.228|||||Comparison of Weighted Mean FEV1 between Placebo and GW870086 1 mg.|||0.228|-0.176|
72352131|NCT00857857|144223932|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.18|STANDARD_ERROR_OF_MEAN|0.0945|||TWO_SIDED|95.0|-0.011|0.371|||||Comparison of Weighted Mean FEV1 between Placebo and GW870086 3 mg.|||0.371|-0.011|
72352132|NCT00857857|144223932|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.35|STANDARD_ERROR_OF_MEAN|0.0978|||TWO_SIDED|95.0|0.153|0.548|||||Comparison of Weighted Mean FEV1 between Placebo and fluticasone propionate 0.25 mg BID.|||0.548|0.153|
72352133|NCT00857857|144223933|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric mean|0.71|STANDARD_ERROR_OF_MEAN|0.116|||TWO_SIDED|95.0|0.56|0.9||||||||0.90|0.56|
72352134|NCT00857857|144223933|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric mean|0.66|STANDARD_ERROR_OF_MEAN|0.107|||TWO_SIDED|95.0|0.53|0.82||||||||0.82|0.53|
72352135|NCT00857857|144223933|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric mean|0.59|STANDARD_ERROR_OF_MEAN|0.112|||TWO_SIDED|95.0|0.47|0.74||||||||0.74|0.47|
72352136|NCT00857857|144223933|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric mean|0.45|STANDARD_ERROR_OF_MEAN|0.107|||TWO_SIDED|95.0|0.36|0.55||||||||0.55|0.36|
72352137|NCT00857857|144223939|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.021|STANDARD_ERROR_OF_MEAN|0.1086|||TWO_SIDED|95.0|-0.199|0.24|||||Comparison of FEV1 between placebo and GW870086 0.25 mg OD at 5 minutes|||0.240|-0.199|
72352138|NCT00857857|144223939|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.164|STANDARD_ERROR_OF_MEAN|0.1285|||TWO_SIDED|95.0|-0.096|0.424|||||Comparison of FEV1 between placebo and GW870086 0.25 mg OD at 10 minutes|||0.424|-0.096|
72352139|NCT00857857|144223939|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.024|STANDARD_ERROR_OF_MEAN|0.1526|||TWO_SIDED|95.0|-0.285|0.333|||||Comparison of FEV1 between placebo and GW870086 0.25 mg OD at 15 minutes|||0.333|-0.285|
72352140|NCT00857857|144223939|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.069|STANDARD_ERROR_OF_MEAN|0.1471|||TWO_SIDED|95.0|-0.229|0.366|||||Comparison of FEV1 between placebo and GW870086 0.25 mg OD at 20 minutes|||0.366|-0.229|
72352141|NCT00857857|144223939|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.011|STANDARD_ERROR_OF_MEAN|0.1313|||TWO_SIDED|95.0|-0.277|0.254|||||Comparison of FEV1 between placebo and GW870086 0.25 mg OD at 30 minutes|||0.254|-0.277|
72352142|NCT00857857|144223939|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.016|STANDARD_ERROR_OF_MEAN|0.141|||TWO_SIDED|95.0|-0.269|0.302|||||Comparison of FEV1 between placebo and GW870086 0.25 mg OD at 45 minutes|||0.302|-0.269|
72352143|NCT00857857|144223939|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.046|STANDARD_ERROR_OF_MEAN|0.1265|||TWO_SIDED|95.0|-0.21|0.301|||||Comparison of FEV1 between placebo and GW870086 0.25 mg OD at 1 hour|||0.301|-0.210|
72352144|NCT00857857|144223939|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.045|STANDARD_ERROR_OF_MEAN|0.1102|||TWO_SIDED|95.0|-0.178|0.268|||||Comparison of FEV1 between placebo and GW870086 0.25 mg OD at 1.5 hours|||0.268|-0.178|
72352145|NCT00857857|144223939|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.096|STANDARD_ERROR_OF_MEAN|0.0985|||TWO_SIDED|95.0|-0.103|0.295|||||Comparison of FEV1 between placebo and GW870086 0.25 mg OD at 2 hours|||0.295|-0.103|
72352146|NCT00857857|144223939|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.045|STANDARD_ERROR_OF_MEAN|0.0826|||TWO_SIDED|95.0|-0.121|0.212|||||Comparison of FEV1 between placebo and GW870086 0.25 mg OD at 2.5 hours|||0.212|-0.121|
72352147|NCT00857857|144223939|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.027|STANDARD_ERROR_OF_MEAN|0.0832|||TWO_SIDED|95.0|-0.141|0.196|||||Comparison of FEV1 between placebo and GW870086 0.25 mg OD at 3 hours|||0.196|-0.141|
72352148|NCT00857857|144223939|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.042|STANDARD_ERROR_OF_MEAN|0.0888|||TWO_SIDED|95.0|-0.138|0.221|||||Comparison of FEV1 between placebo and GW870086 0.25 mg OD at 3.5 hours|||0.221|-0.138|
72352149|NCT00857857|144223939|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.027|STANDARD_ERROR_OF_MEAN|0.0934|||TWO_SIDED|95.0|-0.215|0.162|||||Comparison of FEV1 between placebo and GW870086 0.25 mg OD at 4 hour|||0.162|-0.215|
72352150|NCT00857857|144223939|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.139|STANDARD_ERROR_OF_MEAN|0.1065|||TWO_SIDED|95.0|-0.076|0.354|||||Comparison of FEV1 between placebo and GW870086 0.25 mg OD at 4.5 hours|||0.354|-0.076|
72352151|NCT00857857|144223939|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.149|STANDARD_ERROR_OF_MEAN|0.0955|||TWO_SIDED|95.0|-0.044|0.342|||||Comparison of FEV1 between placebo and GW870086 0.25 mg OD at 5 hours|||0.342|-0.044|
72352152|NCT00857857|144223939|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.084|STANDARD_ERROR_OF_MEAN|0.1005|||TWO_SIDED|95.0|-0.119|0.288|||||Comparison of FEV1 between placebo and GW870086 0.25 mg OD at 5.5 hours|||0.288|-0.119|
72352153|NCT00857857|144223939|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.212|STANDARD_ERROR_OF_MEAN|0.1122|||TWO_SIDED|95.0|-0.015|0.438|||||Comparison of FEV1 between placebo and GW870086 0.25 mg OD at 6 hours|||0.438|-0.015|
72352154|NCT00857857|144223939|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.162|STANDARD_ERROR_OF_MEAN|0.1051|||TWO_SIDED|95.0|-0.051|0.374|||||Comparison of FEV1 between placebo and GW870086 0.25 mg OD at 6.5 hours|||0.374|-0.051|
72352155|NCT00857857|144223939|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.222|STANDARD_ERROR_OF_MEAN|0.1181|||TWO_SIDED|95.0|-0.017|0.461|||||Comparison of FEV1 between placebo and GW870086 0.25 mg OD at 7 hour|||0.461|-0.017|
72352156|NCT00857857|144223939|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.185|STANDARD_ERROR_OF_MEAN|0.1355|||TWO_SIDED|95.0|-0.089|0.458|||||Comparison of FEV1 between placebo and GW870086 0.25 mg OD at 7.5 hours|||0.458|-0.089|
72352157|NCT00857857|144223939|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.247|STANDARD_ERROR_OF_MEAN|0.1187|||TWO_SIDED|95.0|0.007|0.487|||||Comparison of FEV1 between placebo and GW870086 0.25 mg OD at 8 hours|||0.487|0.007|
72352158|NCT00857857|144223939|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.244|STANDARD_ERROR_OF_MEAN|0.1313|||TWO_SIDED|95.0|-0.021|0.509|||||Comparison of FEV1 between placebo and GW870086 0.25 mg OD at 8.5 hours|||0.509|-0.021|
72352159|NCT00857857|144223939|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.154|STANDARD_ERROR_OF_MEAN|0.1189|||TWO_SIDED|95.0|-0.086|0.394|||||Comparison of FEV1 between placebo and GW870086 0.25 mg OD at 9 hours|||0.394|-0.086|
72352160|NCT00857857|144223939|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.175|STANDARD_ERROR_OF_MEAN|0.1085|||TWO_SIDED|95.0|-0.044|0.394|||||Comparison of FEV1 between placebo and GW870086 0.25 mg OD at 9.5 hours|||0.394|-0.044|
72352161|NCT00857857|144223939|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.085|STANDARD_ERROR_OF_MEAN|0.1024|||TWO_SIDED|95.0|-0.122|0.292|||||Comparison of FEV1 between placebo and GW870086 0.25 mg OD at 10 hours|||0.292|-0.122|
72352162|NCT00857857|144223939|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.072|STANDARD_ERROR_OF_MEAN|0.1125|||TWO_SIDED|95.0|-0.155|0.3|||||Comparison of FEV1 between placebo and GW870086 1 mg OD at 5 minutes|||0.300|-0.155|
72352163|NCT00857857|144223939|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.051|STANDARD_ERROR_OF_MEAN|0.1303|||TWO_SIDED|95.0|-0.213|0.314|||||Comparison of FEV1 between placebo and GW870086 1 mg OD at 10 minutes|||0.314|-0.213|
72352164|NCT00857857|144223939|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.142|STANDARD_ERROR_OF_MEAN|0.1572|||TWO_SIDED|95.0|-0.176|0.461|||||Comparison of FEV1 between placebo and GW870086 1 mg OD at 15 minutes|||0.461|-0.176|
72352165|NCT00857857|144223939|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.094|STANDARD_ERROR_OF_MEAN|0.1494|||TWO_SIDED|95.0|-0.208|0.396|||||Comparison of FEV1 between placebo and GW870086 1 mg OD at 20 minutes|||0.396|-0.208|
72352166|NCT00857857|144223939|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.058|STANDARD_ERROR_OF_MEAN|0.1332|||TWO_SIDED|95.0|-0.212|0.327|||||Comparison of FEV1 between placebo and GW870086 1 mg OD at 30 minutes|||0.327|-0.212|
72352167|NCT00857857|144223939|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.065|STANDARD_ERROR_OF_MEAN|0.143|||TWO_SIDED|95.0|-0.224|0.354|||||Comparison of FEV1 between placebo and GW870086 1 mg OD at 45 minutes|||0.354|-0.224|
72352168|NCT00857857|144223939|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.016|STANDARD_ERROR_OF_MEAN|0.1283|||TWO_SIDED|95.0|-0.276|0.243|||||Comparison of FEV1 between placebo and GW870086 1 mg OD at 1 hour|||0.243|-0.276|
72352169|NCT00857857|144223939|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.017|STANDARD_ERROR_OF_MEAN|0.1118|||TWO_SIDED|95.0|-0.209|0.244|||||Comparison of FEV1 between placebo and GW870086 1 mg OD at 1.5 hours|||0.244|-0.209|
72352170|NCT00857857|144223939|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.148|STANDARD_ERROR_OF_MEAN|0.0998|||TWO_SIDED|95.0|-0.35|0.053|||||Comparison of FEV1 between placebo and GW870086 1 mg OD at 2 hours|||0.053|-0.350|
72352171|NCT00857857|144223939|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.086|STANDARD_ERROR_OF_MEAN|0.0829|||TWO_SIDED|95.0|-0.253|0.082|||||Comparison of FEV1 between placebo and GW870086 1 mg OD at 2.5 hours|||0.082|-0.253|
72352172|NCT00857857|144223939|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.04|STANDARD_ERROR_OF_MEAN|0.0843|||TWO_SIDED|95.0|-0.211|0.13|||||Comparison of FEV1 between placebo and GW870086 1 mg OD at 3 hours|||0.130|-0.211|
72352173|NCT00857857|144223939|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.02|STANDARD_ERROR_OF_MEAN|0.09|||TWO_SIDED|95.0|-0.161|0.202|||||Comparison of FEV1 between placebo and GW870086 1 mg OD at 3.5 hours|||0.202|-0.161|
72352174|NCT00857857|144223939|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.005|STANDARD_ERROR_OF_MEAN|0.0947|||TWO_SIDED|95.0|-0.196|0.186|||||Comparison of FEV1 between placebo and GW870086 1 mg OD at 4 hour|||0.186|-0.196|
72352175|NCT00857857|144223939|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.113|STANDARD_ERROR_OF_MEAN|0.1079|||TWO_SIDED|95.0|-0.105|0.33|||||Comparison of FEV1 between placebo and GW870086 1 mg OD at 4.5 hours|||0.330|-0.105|
72352176|NCT00857857|144223939|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.13|STANDARD_ERROR_OF_MEAN|0.0968|||TWO_SIDED|95.0|-0.065|0.326|||||Comparison of FEV1 between placebo and GW870086 1 mg OD at 5 hours|||0.326|-0.065|
72352177|NCT00857857|144223939|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.007|STANDARD_ERROR_OF_MEAN|0.1019|||TWO_SIDED|95.0|-0.213|0.199|||||Comparison of FEV1 between placebo and GW870086 1 mg OD at 5.5 hours|||0.199|-0.213|
72352178|NCT00857857|144223939|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.178|STANDARD_ERROR_OF_MEAN|0.1138|||TWO_SIDED|95.0|-0.052|0.407|||||Comparison of FEV1 between placebo and GW870086 1 mg OD at 6 hours|||0.407|-0.052|
72352179|NCT00857857|144223939|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.135|STANDARD_ERROR_OF_MEAN|0.1065|||TWO_SIDED|95.0|-0.08|0.351|||||Comparison of FEV1 between placebo and GW870086 1 mg OD at 6.5 hours|||0.351|-0.080|
72352180|NCT00857857|144223939|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.179|STANDARD_ERROR_OF_MEAN|0.1198|||TWO_SIDED|95.0|-0.062|0.421|||||Comparison of FEV1 between placebo and GW870086 1 mg OD at 7 hour|||0.421|-0.062|
72352181|NCT00857857|144223939|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.146|STANDARD_ERROR_OF_MEAN|0.1373|||TWO_SIDED|95.0|-0.131|0.423|||||Comparison of FEV1 between placebo and GW870086 1 mg OD at 7.5 hours|||0.423|-0.131|
72352182|NCT00857857|144223939|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.168|STANDARD_ERROR_OF_MEAN|0.1203|||TWO_SIDED|95.0|-0.075|0.411|||||Comparison of FEV1 between placebo and GW870086 1 mg OD at 8 hours|||0.411|-0.075|
72352183|NCT00857857|144223939|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.222|STANDARD_ERROR_OF_MEAN|0.1331|||TWO_SIDED|95.0|-0.047|0.49|||||Comparison of FEV1 between placebo and GW870086 1 mg OD at 8.5 hours|||0.490|-0.047|
72352184|NCT00857857|144223939|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.143|STANDARD_ERROR_OF_MEAN|0.1206|||TWO_SIDED|95.0|-0.1|0.387|||||Comparison of FEV1 between placebo and GW870086 1 mg OD at 9 hours|||0.387|-0.100|
72352185|NCT00857857|144223939|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.187|STANDARD_ERROR_OF_MEAN|0.11|||TWO_SIDED|95.0|-0.035|0.41|||||Comparison of FEV1 between placebo and GW870086 1 mg OD at 9.5 hours|||0.410|-0.035|
72352186|NCT00857857|144223939|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.168|STANDARD_ERROR_OF_MEAN|0.1039|||TWO_SIDED|95.0|-0.042|0.378|||||Comparison of FEV1 between placebo and GW870086 1 mg OD at 10 hours|||0.378|-0.042|
72352187|NCT00857857|144223939|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.221|STANDARD_ERROR_OF_MEAN|0.1036|||TWO_SIDED|95.0|0.011|0.431|||||Comparison of FEV1 between placebo and GW870086 3 mg OD at 5 minutes|||0.431|0.011|
72352188|NCT00857857|144223939|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.244|STANDARD_ERROR_OF_MEAN|0.1236|||TWO_SIDED|95.0|-0.006|0.494|||||Comparison of FEV1 between placebo and GW870086 3 mg OD at 10 minutes|||0.494|-0.006|
72352189|NCT00857857|144223939|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.255|STANDARD_ERROR_OF_MEAN|0.1445|||TWO_SIDED|95.0|-0.038|0.548|||||Comparison of FEV1 between placebo and GW870086 3 mg OD at 15 minutes|||0.548|-0.038|
72352190|NCT00857857|144223939|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.233|STANDARD_ERROR_OF_MEAN|0.1436|||TWO_SIDED|95.0|-0.057|0.524|||||Comparison of FEV1 between placebo and GW870086 3 mg OD at 20 minutes|||0.524|-0.057|
72352191|NCT00857857|144223939|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.219|STANDARD_ERROR_OF_MEAN|0.1262|||TWO_SIDED|95.0|-0.036|0.474|||||Comparison of FEV1 between placebo and GW870086 3 mg OD at 30 minutes|||0.474|-0.036|
72352192|NCT00857857|144223939|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.294|STANDARD_ERROR_OF_MEAN|0.1355|||TWO_SIDED|95.0|0.019|0.568|||||Comparison of FEV1 between placebo and GW870086 3 mg OD at 45 minutes|||0.568|0.019|
72352193|NCT00857857|144223939|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.227|STANDARD_ERROR_OF_MEAN|0.1216|||TWO_SIDED|95.0|-0.019|0.473|||||Comparison of FEV1 between placebo and GW870086 3 mg OD at 1 hour|||0.473|-0.019|
72352194|NCT00857857|144223939|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.204|STANDARD_ERROR_OF_MEAN|0.1059|||TWO_SIDED|95.0|-0.01|0.418|||||Comparison of FEV1 between placebo and GW870086 3 mg OD at 1.5 hours|||0.418|-0.010|
72352195|NCT00857857|144223939|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.116|STANDARD_ERROR_OF_MEAN|0.0947|||TWO_SIDED|95.0|-0.075|0.308|||||Comparison of FEV1 between placebo and GW870086 3 mg OD at 2 hours|||0.308|-0.075|
72352196|NCT00857857|144223939|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.027|STANDARD_ERROR_OF_MEAN|0.0805|||TWO_SIDED|95.0|-0.136|0.19|||||Comparison of FEV1 between placebo and GW870086 3 mg OD at 2.5 hours|||0.190|-0.136|
72352197|NCT00857857|144223939|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.046|STANDARD_ERROR_OF_MEAN|0.0801|||TWO_SIDED|95.0|-0.116|0.208|||||Comparison of FEV1 between placebo and GW870086 3 mg OD at 3 hours|||0.208|-0.116|
72352198|NCT00857857|144223939|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.074|STANDARD_ERROR_OF_MEAN|0.0855|||TWO_SIDED|95.0|-0.099|0.247|||||Comparison of FEV1 between placebo and GW870086 3 mg OD at 3.5 hour|||0.247|-0.099|
72352199|NCT00857857|144223939|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.131|STANDARD_ERROR_OF_MEAN|0.09|||TWO_SIDED|95.0|-0.051|0.313|||||Comparison of FEV1 between placebo and GW870086 3 mg OD at 4 hours|||0.313|-0.051|
72352200|NCT00857857|144223939|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.204|STANDARD_ERROR_OF_MEAN|0.1025|||TWO_SIDED|95.0|-0.004|0.411|||||Comparison of FEV1 between placebo and GW870086 3 mg OD at 4.5 hours|||0.411|-0.004|
72352201|NCT00857857|144223939|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.181|STANDARD_ERROR_OF_MEAN|0.0918|||TWO_SIDED|95.0|-0.004|0.367|||||Comparison of FEV1 between placebo and GW870086 3 mg OD at 5 hours|||0.367|-0.004|
72352202|NCT00857857|144223939|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.178|STANDARD_ERROR_OF_MEAN|0.0967|||TWO_SIDED|95.0|-0.018|0.373|||||Comparison of FEV1 between placebo and GW870086 3 mg OD at 5.5 hours|||0.373|-0.018|
72352203|NCT00857857|144223939|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.288|STANDARD_ERROR_OF_MEAN|0.1079|||TWO_SIDED|95.0|0.07|0.506|||||Comparison of FEV1 between placebo and GW870086 3 mg OD at 6 hours|||0.506|0.070|
72352204|NCT00857857|144223939|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.283|STANDARD_ERROR_OF_MEAN|0.1011|||TWO_SIDED|95.0|0.079|0.488|||||Comparison of FEV1 between placebo and GW870086 3 mg OD at 6.5 hours|||0.488|0.079|
72352205|NCT00857857|144223939|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.386|STANDARD_ERROR_OF_MEAN|0.1137|||TWO_SIDED|95.0|0.157|0.616|||||Comparison of FEV1 between placebo and GW870086 3 mg OD at 7 hour|||0.616|0.157|
72352206|NCT00857857|144223939|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.372|STANDARD_ERROR_OF_MEAN|0.1306|||TWO_SIDED|95.0|0.108|0.636|||||Comparison of FEV1 between placebo and GW870086 3 mg OD at 7.5 hours|||0.636|0.108|
72352207|NCT00857857|144223939|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.458|STANDARD_ERROR_OF_MEAN|0.1142|||TWO_SIDED|95.0|0.227|0.688|||||Comparison of FEV1 between placebo and GW870086 3 mg OD at 8 hours|||0.688|0.227|
72352208|NCT00857857|144223939|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.509|STANDARD_ERROR_OF_MEAN|0.1264|||TWO_SIDED|95.0|0.254|0.765|||||Comparison of FEV1 between placebo and GW870086 3 mg OD at 8.5 hours|||0.765|0.254|
72352209|NCT00857857|144223939|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.492|STANDARD_ERROR_OF_MEAN|0.1144|||TWO_SIDED|95.0|0.261|0.723|||||Comparison of FEV1 between placebo and GW870086 3 mg OD at 9 hours|||0.723|0.261|
72352210|NCT00857857|144223939|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.414|STANDARD_ERROR_OF_MEAN|0.1042|||TWO_SIDED|95.0|0.203|0.625|||||Comparison of FEV1 between placebo and GW870086 3 mg OD at 9.5 hours|||0.625|0.203|
72352211|NCT00857857|144223939|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.44|STANDARD_ERROR_OF_MEAN|0.0984|||TWO_SIDED|95.0|0.241|0.639|||||Comparison of FEV1 between placebo and GW870086 3 mg OD at 10 hours|||0.639|0.241|
72352212|NCT00857857|144223939|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.348|STANDARD_ERROR_OF_MEAN|0.1056|||TWO_SIDED|95.0|0.135|0.562|||||Comparison of FEV1 between placebo and fluticasone propionate 0.25 mg BID at 5 minutes|||0.562|0.135|
72352213|NCT00857857|144223939|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.494|STANDARD_ERROR_OF_MEAN|0.1273|||TWO_SIDED|95.0|0.237|0.751|||||Comparison of FEV1 between placebo and fluticasone propionate 0.25 mg BID at 10 minutes|||0.751|0.237|
72352214|NCT00857857|144223939|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.499|STANDARD_ERROR_OF_MEAN|0.1484|||TWO_SIDED|95.0|0.199|0.8|||||Comparison of FEV1 between placebo and fluticasone propionate 0.25 mg BID at 15 minutes|||0.800|0.199|
72352215|NCT00857857|144223939|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.573|STANDARD_ERROR_OF_MEAN|0.1481|||TWO_SIDED|95.0|0.274|0.872|||||Comparison of FEV1 between placebo and fluticasone propionate 0.25 mg BID at 20 minutes|||0.872|0.274|
72352216|NCT00857857|144223939|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.488|STANDARD_ERROR_OF_MEAN|0.1303|||TWO_SIDED|95.0|0.225|0.751|||||Comparison of FEV1 between placebo and fluticasone propionate 0.25 mg BID at 30 minutes|||0.751|0.225|
72352217|NCT00857857|144223939|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.38|STANDARD_ERROR_OF_MEAN|0.1398|||TWO_SIDED|95.0|0.098|0.663|||||Comparison of FEV1 between placebo and fluticasone propionate 0.25 mg BID at 45 minutes|||0.663|0.098|
72352218|NCT00857857|144223939|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.342|STANDARD_ERROR_OF_MEAN|0.1254|||TWO_SIDED|95.0|0.089|0.596|||||Comparison of FEV1 between placebo and fluticasone propionate 0.25 mg BID at 1 hour|||0.596|0.089|
72352219|NCT00857857|144223939|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.218|STANDARD_ERROR_OF_MEAN|0.1094|||TWO_SIDED|95.0|-0.003|0.439|||||Comparison of FEV1 between placebo and fluticasone propionate 0.25 mg BID at 1.5 hours|||0.439|-0.003|
72352220|NCT00857857|144223939|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.127|STANDARD_ERROR_OF_MEAN|0.0974||||95.0|-0.07|0.323|||||Comparison of FEV1 between placebo and fluticasone propionate 0.25 mg BID at 2 hours|||0.323|-0.070|
72352221|NCT00857857|144223939|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.058|STANDARD_ERROR_OF_MEAN|0.0818|||TWO_SIDED|95.0|-0.107|0.223|||||Comparison of FEV1 between placebo and fluticasone propionate 0.25 mg BID at 2.5 hours|||0.223|-0.107|
72352222|NCT00857857|144223939|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.027|STANDARD_ERROR_OF_MEAN|0.0821|||TWO_SIDED|95.0|-0.192|0.139|||||Comparison of FEV1 between placebo and fluticasone propionate 0.25 mg BID at 3 hours|||0.139|-0.192|
72352223|NCT00857857|144223939|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.091|STANDARD_ERROR_OF_MEAN|0.0876|||TWO_SIDED|95.0|-0.085|0.268|||||Comparison of FEV1 between placebo and fluticasone propionate 0.25 mg BID at 3.5 hours|||0.268|-0.085|
72352224|NCT00857857|144223939|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.084|STANDARD_ERROR_OF_MEAN|0.0921|||TWO_SIDED|95.0|-0.102|0.269|||||Comparison of FEV1 between placebo and fluticasone propionate 0.25 mg BID at 4 hour|||0.269|-0.102|
72352225|NCT00857857|144223939|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.249|STANDARD_ERROR_OF_MEAN|0.105|||TWO_SIDED|95.0|0.038|0.461|||||Comparison of FEV1 between placebo and fluticasone propionate 0.25 mg BID at 4.5 hours|||0.461|0.038|
72352226|NCT00857857|144223939|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.238|STANDARD_ERROR_OF_MEAN|0.0945|||TWO_SIDED|95.0|0.047|0.429|||||Comparison of FEV1 between placebo and fluticasone propionate 0.25 mg BID at 5 hours|||0.429|0.047|
72352227|NCT00857857|144223939|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.315|STANDARD_ERROR_OF_MEAN|0.0995|||TWO_SIDED|95.0|0.114|0.516|||||Comparison of FEV1 between placebo and fluticasone propionate 0.25 mg BID at 5.5 hours|||0.516|0.114|
72352228|NCT00857857|144223939|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.367|STANDARD_ERROR_OF_MEAN|0.1111|||TWO_SIDED|95.0|0.143|0.591|||||Comparison of FEV1 between placebo and fluticasone propionate 0.25 mg BID at 6 hours|||0.591|0.143|
72352229|NCT00857857|144223939|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.361|STANDARD_ERROR_OF_MEAN|0.104|||TWO_SIDED|95.0|0.151|0.571|||||Comparison of FEV1 between placebo and fluticasone propionate 0.25 mg BID at 6.5 hours|||0.571|0.151|
72352230|NCT00857857|144223939|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.367|STANDARD_ERROR_OF_MEAN|0.1168|||TWO_SIDED|95.0|0.131|0.602|||||Comparison of FEV1 between placebo and fluticasone propionate 0.25 mg BID at 7 hour|||0.602|0.131|
72352231|NCT00857857|144223939|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.424|STANDARD_ERROR_OF_MEAN|0.1336|||TWO_SIDED|95.0|0.155|0.694|||||Comparison of FEV1 between placebo and fluticasone propionate 0.25 mg BID at 7.5 hours|||0.694|0.155|
72352232|NCT00857857|144223939|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.556|STANDARD_ERROR_OF_MEAN|0.1174|||TWO_SIDED|95.0|0.319|0.793|||||Comparison of FEV1 between placebo and fluticasone propionate 0.25 mg BID at 8 hours|||0.793|0.319|
72352233|NCT00857857|144223939|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.593|STANDARD_ERROR_OF_MEAN|0.1297||||95.0|0.331|0.854|||||Comparison of FEV1 between placebo and fluticasone propionate 0.25 mg BID at 8.5 hours|||0.854|0.331|
72352234|NCT00857857|144223939|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.559|STANDARD_ERROR_OF_MEAN|0.1177|||TWO_SIDED|95.0|0.322|0.797|||||Comparison of FEV1 between placebo and fluticasone propionate 0.25 mg BID at 9 hours|||0.797|0.322|
72352235|NCT00857857|144223939|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.522|STANDARD_ERROR_OF_MEAN|0.1076||||95.0|0.304|0.739|||||Comparison of FEV1 between placebo and fluticasone propionate 0.25 mg BID at 9.5 hours|||0.739|0.304|
72352236|NCT00857857|144223939|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.514|STANDARD_ERROR_OF_MEAN|0.1017||||95.0|0.308|0.719|||||Comparison of FEV1 between placebo and fluticasone propionate 0.25 mg BID at 10 hours|||0.719|0.308|
72352237|NCT00857857|144223941|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.295|STANDARD_ERROR_OF_MEAN|0.1038||||95.0|0.086|0.503|||||Comparison of FEV1 between placebo and GW870086 0.25 mg OD at Day 7|||0.503|0.086|
72352238|NCT00857857|144223941|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.185|STANDARD_ERROR_OF_MEAN|0.0884|||TWO_SIDED|95.0|0.007|0.363|||||Comparison of FEV1 between placebo and GW870086 0.25 mg OD at Day 13|||0.363|0.007|
72352239|NCT00857857|144223941|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.144|STANDARD_ERROR_OF_MEAN|0.1026|||TWO_SIDED|95.0|-0.062|0.351|||||Comparison of FEV1 between placebo and GW870086 0.25 mg OD at Day 14|||0.351|-0.062|
72352240|NCT00857857|144223941|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.33|STANDARD_ERROR_OF_MEAN|0.0979|||TWO_SIDED|95.0|0.133|0.527|||||Comparison of FEV1 between placebo and GW870086 1 mg OD at Day 7|||0.527|0.133|
72352241|NCT00857857|144223941|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.081|STANDARD_ERROR_OF_MEAN|0.0856|||TWO_SIDED|95.0|-0.092|0.253|||||Comparison of FEV1 between placebo and GW870086 1 mg OD at Day 13|||0.253|-0.092|
72352242|NCT00857857|144223941|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.126|STANDARD_ERROR_OF_MEAN|0.1|||TWO_SIDED|95.0|-0.076|0.327|||||Comparison of FEV1 between placebo and GW870086 1 mg OD at Day 14|||0.327|-0.076|
72352243|NCT00857857|144223941|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.297|STANDARD_ERROR_OF_MEAN|0.0976|||TWO_SIDED|95.0|0.1|0.493|||||Comparison of FEV1 between placebo and GW870086 3 mg OD at Day 7|||0.493|0.100|
72352244|NCT00857857|144223941|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.256|STANDARD_ERROR_OF_MEAN|0.0859|||TWO_SIDED|95.0|0.083|0.429|||||Comparison of FEV1 between placebo and GW870086 3 mg OD at Day 13|||0.429|0.083|
72352245|NCT00857857|144223941|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.462|STANDARD_ERROR_OF_MEAN|0.0991|||TWO_SIDED|95.0|0.262|0.662|||||Comparison of FEV1 between placebo and GW870086 3 mg OD at Day 14|||0.662|0.262|
72352246|NCT00857857|144223941|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.323|STANDARD_ERROR_OF_MEAN|0.0982|||TWO_SIDED|95.0|0.125|0.52|||||Comparison of FEV1 between placebo and fluticasone propionate 0.25 mg BID at Day 7|||0.520|0.125|
72352247|NCT00857857|144223941|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.229|STANDARD_ERROR_OF_MEAN|0.0858|||TWO_SIDED|95.0|0.057|0.402|||||Comparison of FEV1 between placebo and fluticasone propionate 0.25 mg BID at Day 13|||0.402|0.057|
72352248|NCT00857857|144223941|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.372|STANDARD_ERROR_OF_MEAN|0.0991|||TWO_SIDED|95.0|0.172|0.572|||||Comparison of FEV1 between placebo and fluticasone propionate 0.25 mg BID at Day 14|||0.572|0.172|
72352249|NCT00857857|144223951|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.32|STANDARD_ERROR_OF_MEAN|0.482|||TWO_SIDED|95.0|-1.3|0.66|||||Doubling dose differences, that is a treatment doubling dose difference of 1 indicates that the concentration of methacholine required to cause a 20% fall in FEV1 in one treatment is twice that in the other (log2\[2\] = 1).|||0.66|-1.30|
72352250|NCT00857857|144223951|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.27|STANDARD_ERROR_OF_MEAN|0.495|||TWO_SIDED|95.0|-0.73|1.28|||||Doubling dose differences, that is a treatment doubling dose difference of 1 indicates that the concentration of methacholine required to cause a 20% fall in FEV1 in one treatment is twice that in the other (log2\[2\] = 1).|||1.28|-0.73|
72352251|NCT00857857|144223951|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.28|STANDARD_ERROR_OF_MEAN|0.45|||TWO_SIDED|95.0|0.36|2.19|||||Doubling dose differences, that is a treatment doubling dose difference of 1 indicates that the concentration of methacholine required to cause a 20% fall in FEV1 in one treatment is twice that in the other (log2\[2\] = 1).|||2.19|0.36|
72352252|NCT00857857|144223951|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.79|STANDARD_ERROR_OF_MEAN|0.469|||TWO_SIDED|95.0|0.84|2.75|||||Doubling dose differences, that is a treatment doubling dose difference of 1 indicates that the concentration of methacholine required to cause a 20% fall in FEV1 in one treatment is twice that in the other (log2\[2\] = 1).|||2.75|0.84|
72352253|NCT02709330|144223984|OTHER|||||||0.99|||||||Kolmogorov-Smirnov Test|||Matched historical controls will be identified from the PatientsLikeMe database.||||0.99
72352254|NCT02709330|144223985|OTHER|||||||0.0748|||||||ANOVA|||||||0.0748
72352255|NCT02709330|144223986|OTHER||||||<|1e-05|||||||Lin's Concordance|||||||<0.00001
72352256|NCT02709330|144223990|OTHER||||||<|1e-05|||||||Lin's Concordance|||||||<0.00001
72352257|NCT01279681|144223991|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.03||||0.93|TWO_SIDED|95.0|0.49|2.17|||Regression, Cox|||||2.17|0.49|0.93
72352258|NCT00181363|144224008|SUPERIORITY||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
72352259|NCT00181363|144224009|SUPERIORITY||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
72352260|NCT00181363|144224010|SUPERIORITY||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
72352261|NCT00181363|144224011|SUPERIORITY||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
72352262|NCT00181363|144224012|SUPERIORITY||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
72352263|NCT00330759|144224048|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|A synthesis approach was used for a non-inferiority test of the hypothesis that denosumab preserves at least 50% of the effect of zoledronic acid vs. placebo.|Hazard Ratio (HR)|0.84||||0.0007||95.0|0.71|0.98|||Regression, Cox|Stratified by tumor type, previous skeletal-related event, and systematic anti-cancer therapy||||0.98|0.71|0.0007
72352264|NCT00330759|144224049|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.84||||0.06||95.0|0.71|0.98|||Regression, Cox|P-value was adjusted for multiplicity according to a hierarchical testing strategy and Hochberg procedure.|Stratified by tumor type, previous skeletal-related event, and systematic anti-cancer therapy|||0.98|0.71|0.060
72352265|NCT00330759|144224050|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.9||||0.145||95.0|0.77|1.04|||Anderson-Gill model|P-value was adjusted for multiplicity according to a hierarchical testing strategy and Hochberg procedure.|Stratified by tumor type, previous skeletal-related event, and systematic anti-cancer therapy|||1.04|0.77|0.145
72352266|NCT00997035|144224051|SUPERIORITY||Hazard Ratio (HR)|0.82||||0.29|TWO_SIDED|95.0|0.57|1.18|||Regression, Cox|Cox proportional hazards regression to estimate the hazard of perforation or need for TPK.||The sample size was determined based on the primary end point: perforation or the need for TPK within 3 months. Simulation-based analyses estimated that a sample sizeof 240 study participants (120 per arm) would provide 80% power to detect a 15% difference in the 3-month perforation or need for TPK rate between topical antifungal plus oral voriconazole vs topical antifungal alone,with a 2-tailed α value of .05 and approximately 15%loss to follow-up.||1.18|0.57|0.29
72352267|NCT00997035|144224056|SUPERIORITY||Hazard Ratio (HR)|0.87||||0.65|TWO_SIDED|95.0|0.49|1.57|||Regression, Cox|||||1.57|.49|0.65
72352268|NCT00997035|144224058|SUPERIORITY||||||<|0.001||||||Statistically significant after Holms-Šidák correction for multiple comparisons.|Fisher Exact|||||||<0.001
72352269|NCT01072188|144224096|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
72352270|NCT01072188|144224097|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
72352271|NCT04640311|144224116|OTHER||Geometric mean ratio|1.028|||||TWO_SIDED|90.0|0.9699|1.09|||||Geometric mean ratio of Daprodustat Process 1 to Process 2 Dissolution Profile 1 has been presented.|||1.090|0.9699|
72352272|NCT04640311|144224116|OTHER||Geometric mean ratio|1.019|||||TWO_SIDED|90.0|0.9602|1.081|||||Geometric mean ratio of Daprodustat Process 1 to Process 2 Dissolution Profile 2 has been presented.|||1.081|0.9602|
72352273|NCT04640311|144224117|EQUIVALENCE|Bioequivalence was to be determined if the 90 percent (%) confidence interval (CI) of ratio's of geometric means (geometric mean of Process 2/Process 1) falls within a range of 0.80 to 1.25.|Geometric mean ratio|1.029|||||TWO_SIDED|90.0|0.977|1.083|||||Geometric mean ratio of Daprodustat 1 mg Process 2 to Process 1 has been presented.|||1.083|0.9770|
72352274|NCT04640311|144224117|EQUIVALENCE|Bioequivalence was to be determined if the 90% CI of ratio's of geometric means (geometric mean of Process 2/Process 1) falls within a range of 0.80 to 1.25.|Geometric mean ratio|0.9496|||||TWO_SIDED|90.0|0.8914|1.012|||||Geometric mean ratio of Daprodustat 2 mg Process 2 to Process 1 has been presented.|||1.012|0.8914|
72352275|NCT04640311|144224117|EQUIVALENCE|Bioequivalence was to be determined if the 90% CI of ratio's of geometric means (geometric mean of Process 2/Process 1) falls within a range of 0.80 to 1.25.|Geometric mean ratio|1.01|||||TWO_SIDED|90.0|0.9533|1.07|||||Geometric mean ratio of Daprodustat 4 mg Process 2 to Process 1 has been presented.|||1.070|0.9533|
72352276|NCT04640311|144224117|EQUIVALENCE|Bioequivalence was to be determined if the 90% CI of ratio's of geometric means (geometric mean of Process 2/Process 1) falls within a range of 0.80 to 1.25.|Geometric mean ratio|0.9679|||||TWO_SIDED|90.0|0.9115|1.028|||||Geometric mean ratio of Daprodustat 6 mg Process 2 to Process 1 has been presented.|||1.028|0.9115|
72352277|NCT04640311|144224117|EQUIVALENCE|Bioequivalence was to be determined if the 90% CI of ratio's of geometric means (geometric mean of Process 2/Process 1) falls within a range of 0.80 to 1.25.|Geometric mean ratio|0.9511|||||TWO_SIDED|90.0|0.8948|1.011|||||Geometric mean ratio of Daprodustat 8 mg Process 2 to Process 1 has been presented.|||1.011|0.8948|
72352278|NCT04640311|144224118|OTHER||Geometric mean ratio|1.042|||||TWO_SIDED|90.0|0.9308|1.166|||||Geometric mean ratio of Daprodustat Process 1 to Process 2 Dissolution Profile 1 has been presented.|||1.166|0.9308|
72352279|NCT04640311|144224118|OTHER||Geometric mean ratio|1.048|||||TWO_SIDED|90.0|0.9349|1.175|||||Geometric mean ratio of Daprodustat Process 1 to Process 2 Dissolution Profile 2 has been presented.|||1.175|0.9349|
72352280|NCT04640311|144224119|EQUIVALENCE|Bioequivalence was to be determined if the 90% CI of ratio's of geometric means (geometric mean of Process 2/Process 1) falls within a range of 0.80 to 1.25.|Geometric mean ratio|0.9716|||||TWO_SIDED|90.0|0.8936|1.056|||||Geometric mean ratio of Daprodustat 1 mg Process 2 to Process 1 has been presented.|||1.056|0.8936|
72352281|NCT04640311|144224119|EQUIVALENCE|Bioequivalence was to be determined if the 90% CI of ratio's of geometric means (geometric mean of Process 2/Process 1) falls within a range of 0.80 to 1.25.|Geometric mean ratio|0.9006|||||TWO_SIDED|90.0|0.8107|1.0|||||Geometric mean ratio of Daprodustat 2 mg Process 2 to Process 1 has been presented.|||1.000|0.8107|
72352282|NCT04640311|144224119|EQUIVALENCE|Bioequivalence was to be determined if the 90% CI of ratio's of geometric means (geometric mean of Process 2/Process 1) falls within a range of 0.80 to 1.25.|Geometric mean ratio|0.9703|||||TWO_SIDED|90.0|0.8665|1.087|||||Geometric mean ratio of Daprodustat 4 mg Process 2 to Process 1 has been presented.|||1.087|0.8665|
72352283|NCT04640311|144224119|EQUIVALENCE|Bioequivalence was to be determined if the 90% CI of ratio's of geometric means (geometric mean of Process 2/Process 1) falls within a range of 0.80 to 1.25.|Geometric mean ratio|0.9675|||||TWO_SIDED|90.0|0.8778|1.066|||||Geometric mean ratio of Daprodustat 6 mg Process 2 to Process 1 has been presented.|||1.066|0.8778|
72352284|NCT04640311|144224119|EQUIVALENCE|Bioequivalence was to be determined if the 90% CI of ratio's of geometric means (geometric mean of Process 2/Process 1) falls within a range of 0.80 to 1.25.|Geometric mean ratio|0.8606|||||TWO_SIDED|90.0|0.777|0.9532|||||Geometric mean ratio of Daprodustat 8 mg Process 2 to Process 1 has been presented.|||0.9532|0.7770|
72352285|NCT03956550|144224130|SUPERIORITY|||||||0.2978|||||||Mixed Models Analysis|||||||0.2978
72352286|NCT03956550|144224130|SUPERIORITY|||||||0.689|||||||Mixed Models Analysis|||||||0.6890
72352287|NCT03956550|144224131|SUPERIORITY|||||||0.1973|||||||Mixed Models Analysis|||||||0.1973
72352288|NCT03956550|144224131|SUPERIORITY|||||||0.942|||||||Mixed Models Analysis|||||||0.9420
72352289|NCT03956550|144224132|SUPERIORITY|||||||0.1597|||||||Mixed Models Analysis|||||||0.1597
72352290|NCT03956550|144224132|SUPERIORITY|||||||0.9719|||||||Mixed Models Analysis|||||||0.9719
72352291|NCT03956550|144224133|SUPERIORITY|||||||0.1365|||||||Mixed Models Analysis|||||||0.1365
72352292|NCT03956550|144224133|SUPERIORITY|||||||0.0604|||||||Mixed Models Analysis|||||||0.0604
72352293|NCT03956550|144224134|SUPERIORITY|||||||0.0989|||||||Mixed Models Analysis|||||||0.0989
72352294|NCT03956550|144224134|SUPERIORITY|||||||0.5487|||||||Mixed Models Analysis|||||||0.5487
72352295|NCT03956550|144224135|SUPERIORITY|||||||0.3572|||||||Cochran-Mantel-Haenszel|||||||0.3572
72352296|NCT03956550|144224135|SUPERIORITY|||||||0.5747|||||||Cochran-Mantel-Haenszel|||||||0.5747
72352297|NCT03369418|144224148|SUPERIORITY|One tailed t-tests for independent groups were performed to test the hypothesis that active device will be superior to sham in decreasing the combined HAD score. This was accomplished by Contrast analysis within the framework of a random effects general linear mixed effects (RE GLMM) model.||||||0.013||||||A priori threshold for statistical significance was p\<.05.|t-test, 1 sided|||||||.013
72352298|NCT03369418|144224149|SUPERIORITY|||||||0.33|||||||t-test, 1 sided|||||||.33
72352299|NCT01284517|144224162|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.5|STANDARD_ERROR_OF_MEAN|1.08||0.176|||||||Mixed Models Analysis|||Null hypothesis (H0) assumes equal values between analysis groups in mean change from baseline in MADRS score, alternative hypothesis (HA) assumes unequal values between groups. Sample size determined by two-sample t-test. A mean difference of 3.25 units in change in MADRS score for the Lurasdone 20-120 mg arm over placebo with common standard deviation of 9 units was used. N=162 subjects per arm (total N=324) yields power of 90%. A 5% adjustment for drop-outs gives N=340, or N=170 per arm.||||0.176
72352300|NCT01284517|144224163|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.24|STANDARD_ERROR_OF_MEAN|0.141||0.095|||||||Mixed Models Analysis|||||||0.095
72352301|NCT01284517|144224164|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|1.0||0.992|||||||ANCOVA|||||||0.992
72352302|NCT00040443|144224165|OTHER||Mean Difference (Final Values)|5.0|STANDARD_ERROR_OF_MEAN|1.0|<|0.05|TWO_SIDED|95.0|||||t-test, 2 sided|||||||<.05
72352303|NCT02485561|144224182|SUPERIORITY||F-value|1.019||||0.362|TWO_SIDED||||||ANOVA|||||||.362
72352304|NCT02485561|144224183|SUPERIORITY||Mean Difference (Final Values)|0.22|STANDARD_ERROR_OF_MEAN|0.098||0.024|TWO_SIDED||||||t-test, 2 sided|||||||.024
72352305|NCT02485561|144224183|SUPERIORITY||Mean Difference (Final Values)|-0.024|STANDARD_ERROR_OF_MEAN|0.074||0.75|TWO_SIDED||||||t-test, 2 sided|||||||.75
72352306|NCT02485561|144224184|SUPERIORITY||F-value|6.482||||0.002|TWO_SIDED||||||ANOVA|||||||.002
72352307|NCT02485561|144224184|SUPERIORITY||Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.15||0.91|TWO_SIDED||||||t-test, 2 sided|||||||.91
72352308|NCT02485561|144224184|SUPERIORITY||Mean Difference (Final Values)|0.716|STANDARD_ERROR_OF_MEAN|0.182|<|0.001|TWO_SIDED||||||t-test, 2 sided|||||||<.001
72352309|NCT02485561|144224185|SUPERIORITY||F-value|0.608||||0.55|TWO_SIDED||||||ANOVA|||||||0.55
72352310|NCT02485561|144224186|SUPERIORITY||F-value|16.31|||<|0.001|TWO_SIDED||||||ANOVA|||||||<.001
72352311|NCT02485561|144224186|SUPERIORITY||F-value|2.0||||0.14|TWO_SIDED||||||ANOVA|||||||0.14
72352312|NCT02485561|144224187|SUPERIORITY||F-value|1.68||||0.19|TWO_SIDED||||||ANOVA|||||||.19
72352313|NCT02485561|144224187|SUPERIORITY||F-value|0.021||||0.98|TWO_SIDED||||||ANOVA|||||||.98
72352314|NCT02485561|144224187|SUPERIORITY||F-value|0.312||||0.73|TWO_SIDED||||||ANOVA|||||||.73
72352315|NCT02485561|144224187|SUPERIORITY||F-value|0.702||||0.496|TWO_SIDED||||||ANOVA|||||||.496
72352316|NCT02485561|144224187|SUPERIORITY||F-value|1.88||||0.154|TWO_SIDED||||||ANOVA|||||||.154
72352317|NCT02485561|144224187|SUPERIORITY||F-value|0.667||||0.514|TWO_SIDED||||||ANOVA|||||||.514
72352318|NCT02485561|144224187|SUPERIORITY||F-value|0.666||||0.514|TWO_SIDED||||||ANOVA|||||||.514
72352319|NCT02485561|144224188|SUPERIORITY||F-value|0.59||||0.56|TWO_SIDED||||||ANOVA|||||||.56
72352320|NCT02485561|144224189|SUPERIORITY||F-value|0.18||||0.84|TWO_SIDED||||||ANOVA|||||||.84
72352321|NCT02485561|144224190|SUPERIORITY||F-value|1.16||||0.31|TWO_SIDED||||||ANOVA|||||||.31
72352322|NCT02485561|144224191|SUPERIORITY||F-value|1.17||||0.31|TWO_SIDED||||||ANOVA|||||||.31
72352323|NCT02485561|144224191|SUPERIORITY||F-value|0.056||||0.95|TWO_SIDED||||||ANOVA|||||||.95
72352324|NCT02501590|144224192|OTHER|||||||0.05|||||||Wilcoxon (Mann-Whitney)|||||||0.05
72352325|NCT01126723|144224203|SUPERIORITY_OR_OTHER_LEGACY|||||||0.15||||||The a priori threshold for statistical significance was set to 0.05.|Fisher Exact|||||||0.15
72352326|NCT03901144|144224210|SUPERIORITY||Mean Difference (Final Values)|-9.026|||<|0.001|TWO_SIDED|95.0|-12.562|-5.489|||ANCOVA|||Summary of TEWL (g/m2h) change from day 29 to day 31||-5.489|-12.562|<0.001
72352327|NCT03901144|144224210|SUPERIORITY||Mean Difference (Final Values)|-4.194||||0.021|TWO_SIDED|95.0|-7.76|-0.629|||ANCOVA|||Summary of TEWL (g/m2h) change from day 29 to day 31||-0.629|-7.760|0.021
72352328|NCT03901144|144224210|SUPERIORITY||Mean Difference (Final Values)|-9.021|||<|0.001|TWO_SIDED|95.0|-12.602|-5.44|||ANCOVA|||Summary of TEWL (g/m2h) change from day 29 to day 31||-5.440|-12.602|<0.001
72352329|NCT03901144|144224211|SUPERIORITY||Mean Difference (Final Values)|-3.538|||<|0.001|TWO_SIDED|95.0|-5.114|-1.962|||ANCOVA|||Summary of Objective Erythema (2D Skin Imaging) change from day 29 to day 31||-1.962|-5.114|<0.001
72352330|NCT03901144|144224211|SUPERIORITY||Mean Difference (Final Values)|-1.748||||0.031|TWO_SIDED|95.0|-3.332|-0.164|||ANCOVA|||Summary of Objective Erythema (2D Skin Imaging) change from day 29 to day 31||-0.164|-3.332|0.031
72352331|NCT03901144|144224211|SUPERIORITY||Mean Difference (Final Values)|-4.744|||<|0.001|TWO_SIDED|95.0|-6.332|-3.156|||ANCOVA|||Summary of Objective Erythema (2D Skin Imaging) change from day 29 to day 31||-3.156|-6.332|<0.001
72352332|NCT03901144|144224212|SUPERIORITY||Mean Difference (Final Values)|-19.077||||0.002|TWO_SIDED|95.0|-31.325|-6.829|||ANCOVA|||Summary of Redness-Mexameter change from day 29 to day 31||-6.829|-31.325|0.002
72352333|NCT03901144|144224212|SUPERIORITY||Mean Difference (Final Values)|-4.493||||0.471|TWO_SIDED|95.0|-16.787|7.801|||ANCOVA|||||7.801|-16.787|0.471
72352334|NCT03901144|144224212|SUPERIORITY||Mean Difference (Final Values)|-27.035|||<|0.001|TWO_SIDED|95.0|-39.372|-14.698|||ANCOVA|||Summary of Redness - Mexameter change from day 29 to day 31||-14.698|-39.372|<0.001
72352335|NCT03901144|144224214|SUPERIORITY||Mean Difference (Net)|-0.354|||<|0.001|TWO_SIDED|95.0|-0.558|-0.15|||ANCOVA|||Summary of Visual Redness at day 31||-0.150|-0.558|<0.001
72352336|NCT03901144|144224214|SUPERIORITY||Mean Difference (Final Values)|-0.089||||0.392|TWO_SIDED|95.0|-0.292|0.115|||ANCOVA|||Summary of Visual Redness at day 31||0.115|-0.292|0.392
72352337|NCT03901144|144224214|SUPERIORITY||Mean Difference (Final Values)|-0.447|||<|0.001|TWO_SIDED|95.0|-0.652|-0.242|||ANCOVA|||Summary of Visual Redness at day 31||-0.242|-0.652|<0.001
72352338|NCT01332994|144224294|SUPERIORITY_OR_OTHER|||||||0.1648|TWO_SIDED|||||Exact one-sided binomial test on single proportions with a significance level of alpha equals (=) 0.025. Null hypothesis: Proportion of participants reaching DAS28 remission (\<2.6) at Week 16 is ≤45 percent (%).|Exact one-sided binomial test|||||||0.1648
72352339|NCT01332994|144224330|SUPERIORITY_OR_OTHER|||||||0.7559|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Naive B-cell compartment||||0.7559
72352340|NCT01332994|144224330|SUPERIORITY_OR_OTHER|||||||0.8961|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Transitional B-cells||||0.8961
72352341|NCT01332994|144224330|SUPERIORITY_OR_OTHER|||||||0.7915|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Naive B-cells||||0.7915
72352342|NCT01332994|144224330|SUPERIORITY_OR_OTHER|||||||0.8081|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Memory B-cells||||0.8081
72352343|NCT01332994|144224330|SUPERIORITY_OR_OTHER|||||||0.6574|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Pre-switch memory B-cells||||0.6574
72352344|NCT01332994|144224330|SUPERIORITY_OR_OTHER|||||||0.4553|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Post-switch memory B-cells||||0.4553
72369502|NCT02039843|144249199|SUPERIORITY|||||||0.036||||||2-sided a priori alpha level was 0.05|Mixed Models Analysis|Linear mixed repeated measures analysis on group difference in PCL-5 score adjusted for gender, site, baseline score, time, and timeXgroup||||||0.036
72352345|NCT01332994|144224330|SUPERIORITY_OR_OTHER|||||||0.2215|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||IgG-positive class-switched B-cells||||0.2215
72352346|NCT01332994|144224330|SUPERIORITY_OR_OTHER|||||||0.886|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||IgA-positive class-switched B-cells||||0.8860
72352347|NCT01332994|144224330|SUPERIORITY_OR_OTHER|||||||0.8693|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Double-negative B-cells||||0.8693
72352348|NCT01332994|144224330|SUPERIORITY_OR_OTHER|||||||0.9564|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Plasmablasts||||0.9564
72352349|NCT01332994|144224331|SUPERIORITY_OR_OTHER|||||||0.9993|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 16, Naive B-cell compartment||||0.9993
72352350|NCT01332994|144224331|SUPERIORITY_OR_OTHER|||||||0.3596|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 16, Transitional B-cells||||0.3596
72352351|NCT01332994|144224331|SUPERIORITY_OR_OTHER|||||||0.7435|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 16, Naive B-cells||||0.7435
72352352|NCT01332994|144224331|SUPERIORITY_OR_OTHER|||||||0.7671|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 16, Memory B-cells||||0.7671
72352353|NCT01332994|144224331|SUPERIORITY_OR_OTHER|||||||0.7912|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 16, Pre-switch memory B-cells||||0.7912
72352354|NCT01332994|144224331|SUPERIORITY_OR_OTHER|||||||0.5595|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 16, Post-switch memory B-cells||||0.5595
72352355|NCT01332994|144224331|SUPERIORITY_OR_OTHER|||||||0.3817|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 16, IgG-positive class-switched B-cells||||0.3817
72352356|NCT01332994|144224331|SUPERIORITY_OR_OTHER|||||||0.3623|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 16, IgA-positive class-switched B-cells||||0.3623
72352357|NCT01332994|144224331|SUPERIORITY_OR_OTHER|||||||0.7108|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 16, Double-negative B-cells||||0.7108
72352358|NCT01332994|144224331|SUPERIORITY_OR_OTHER|||||||0.0639|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 16, Plasmablasts||||0.0639
72352359|NCT01332994|144224331|SUPERIORITY_OR_OTHER|||||||0.0186|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 24, Naive B-cell compartment||||0.0186
72352360|NCT01332994|144224331|SUPERIORITY_OR_OTHER|||||||0.005|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 24, Transitional B-cells||||0.0050
72352361|NCT01332994|144224331|SUPERIORITY_OR_OTHER|||||||0.0463|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 24, Naive B-cells||||0.0463
72352362|NCT01332994|144224331|SUPERIORITY_OR_OTHER|||||||0.1919|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 24, Memory B-cells||||0.1919
72352363|NCT01332994|144224331|SUPERIORITY_OR_OTHER|||||||0.3071|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 24, Pre-switch memory B-cells||||0.3071
72352364|NCT01332994|144224331|SUPERIORITY_OR_OTHER|||||||0.1714|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 24, Post-switch memory B-cells||||0.1714
72352365|NCT01332994|144224331|SUPERIORITY_OR_OTHER|||||||0.1746|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 24, IgG-positive class-switched B-cells||||0.1746
72352366|NCT01332994|144224331|SUPERIORITY_OR_OTHER|||||||0.1626|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 24, IgA-positive class-switched B-cells||||0.1626
72352367|NCT01332994|144224331|SUPERIORITY_OR_OTHER|||||||0.6304|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 24, Double-negative B-cells||||0.6304
72352368|NCT01332994|144224331|SUPERIORITY_OR_OTHER|||||||0.3449|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 24, Plasmablasts||||0.3449
72352369|NCT01332994|144224331|SUPERIORITY_OR_OTHER|||||||0.0919|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 32, Naive B-cell compartment||||0.0919
72352370|NCT01332994|144224331|SUPERIORITY_OR_OTHER|||||||0.2189|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 32, Transitional B-cells||||0.2189
72352371|NCT01332994|144224331|SUPERIORITY_OR_OTHER|||||||0.1386|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 32, Naive B-cells||||0.1386
72352372|NCT01332994|144224331|SUPERIORITY_OR_OTHER|||||||0.6199|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 32, Memory B-cells||||0.6199
72352373|NCT01332994|144224331|SUPERIORITY_OR_OTHER|||||||0.1019|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 32, Pre-switch memory B-cells||||0.1019
72352374|NCT01332994|144224331|SUPERIORITY_OR_OTHER|||||||0.4353|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 32, Post-switch memory B-cells||||0.4353
72352375|NCT01332994|144224331|SUPERIORITY_OR_OTHER|||||||0.3934|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 32, IgG-positive class-switched B-cells||||0.3934
72352376|NCT01332994|144224331|SUPERIORITY_OR_OTHER|||||||0.4196|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 32, IgA-positive class-switched B-cells||||0.4196
72352377|NCT01332994|144224331|SUPERIORITY_OR_OTHER|||||||0.5546|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 32, Double-negative B-cells||||0.5546
72352378|NCT01332994|144224331|SUPERIORITY_OR_OTHER|||||||0.7695|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 32, Plasmablasts||||0.7695
72352379|NCT01332994|144224332|SUPERIORITY_OR_OTHER|||||||0.6551|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 16, Naive B-cell compartment||||0.6551
72352380|NCT01332994|144224332|SUPERIORITY_OR_OTHER|||||||0.6905|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 16, Transitional B-cells||||0.6905
72352381|NCT01332994|144224332|SUPERIORITY_OR_OTHER|||||||0.9678|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 16, Naive B-cells||||0.9678
72352382|NCT01332994|144224332|SUPERIORITY_OR_OTHER|||||||0.208|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 16, Memory B-cells||||0.2080
72352383|NCT01332994|144224332|SUPERIORITY_OR_OTHER|||||||0.4778|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 16, Pre-switch memory B-cells||||0.4778
72352384|NCT01332994|144224332|SUPERIORITY_OR_OTHER|||||||0.8526|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 16, Post-switch memory B-cells||||0.8526
72352385|NCT01332994|144224332|SUPERIORITY_OR_OTHER|||||||0.7266|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 16, IgG-positive class-switched B-cells||||0.7266
72352386|NCT01332994|144224332|SUPERIORITY_OR_OTHER|||||||0.2011|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 16, IgA-positive class-switched B-cells||||0.2011
72352387|NCT01332994|144224332|SUPERIORITY_OR_OTHER|||||||0.7872|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 16, Double-negative B-cells||||0.7872
72352388|NCT01332994|144224332|SUPERIORITY_OR_OTHER|||||||0.5377|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 16, Plasmablasts||||0.5377
72352389|NCT01332994|144224332|SUPERIORITY_OR_OTHER|||||||0.6238|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 48, Naive B-cell compartment||||0.6238
72352390|NCT01332994|144224332|SUPERIORITY_OR_OTHER|||||||0.2848|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 48, Transitional B-cells||||0.2848
72352391|NCT01332994|144224332|SUPERIORITY_OR_OTHER|||||||0.6238|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 48, Naive B-cells||||0.6238
72352392|NCT01332994|144224332|SUPERIORITY_OR_OTHER|||||||0.2848|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 48, Pre-switch memory B-cells||||0.2848
72352393|NCT01332994|144224332|SUPERIORITY_OR_OTHER|||||||0.7471|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 48, Post-switch memory B-cells||||0.7471
72352394|NCT01332994|144224332|SUPERIORITY_OR_OTHER|||||||0.7471|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 48, IgG-positive class-switched B-cells||||0.7471
72352395|NCT01332994|144224332|SUPERIORITY_OR_OTHER|||||||0.391|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 48, IgA-positive class-switched B-cells||||0.3910
72352396|NCT01332994|144224332|SUPERIORITY_OR_OTHER|||||||0.8729|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 48, Plasmablasts||||0.8729
72352397|NCT01332994|144224332|SUPERIORITY_OR_OTHER|||||||0.7261|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 66, Naive B-cell compartment||||0.7261
72352398|NCT01332994|144224332|SUPERIORITY_OR_OTHER|||||||0.9338|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 66, Transitional B-cells||||0.9338
72352399|NCT01332994|144224332|SUPERIORITY_OR_OTHER|||||||0.9074|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 66, Naive B-cells||||0.9074
72352400|NCT01332994|144224332|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 66, Memory B-cells||||<0.0001
72352401|NCT01332994|144224332|SUPERIORITY_OR_OTHER|||||||0.9338|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 66, Pre-switch memory B-cells||||0.9338
72352402|NCT01332994|144224332|SUPERIORITY_OR_OTHER|||||||0.6515|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 66, Post-switch memory B-cells||||0.6515
72352403|NCT01332994|144224332|SUPERIORITY_OR_OTHER|||||||0.8413|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 66, IgG-positive class-switched B-cells||||0.8413
72352404|NCT01332994|144224332|SUPERIORITY_OR_OTHER|||||||0.7244|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 66, IgA-positive class-switched B-cells||||0.7244
72352405|NCT01332994|144224332|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 66, Double-negative B-cells||||<0.0001
72352406|NCT01332994|144224332|SUPERIORITY_OR_OTHER|||||||0.3848|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 66, Plasmablasts||||0.3848
72352407|NCT00279916|144224351|SUPERIORITY|||||||0.18|||||||Chi-squared|||||||0.18
72352408|NCT00279916|144224352|SUPERIORITY|||||||0.24|||||||Chi-squared|||||||0.24
72352409|NCT02717494|144224368|OTHER||% with grade 3+ AEs, up to week 4 Step 1|2.0|||||TWO_SIDED|90.0|0.0|5.0|||||Confidence intervals were Exact Clopper-Pearson.|||5|0|
72352410|NCT02717494|144224368|OTHER||% with grade 3+ AEs, up to week 4 Step 1|3.0|||||TWO_SIDED|90.0|1.0|7.0|||||Confidence intervals were Exact Clopper-Pearson.|||7|1|
72352411|NCT02717494|144224368|OTHER||% with grade 3+ AEs up to week 4, Step 1|3.0|||||TWO_SIDED|90.0|1.0|8.0|||||Confidence intervals were Exact Clopper-Pearson.|||8|1|
72352412|NCT02717494|144224368|OTHER||% with grade 4+ AEs after week 4, Step 1|1.0|||||TWO_SIDED|90.0|0.0|4.0|||||Confidence intervals were Exact Clopper-Pearson.|||4|0|
72352413|NCT02717494|144224368|OTHER||% with grade 4+ AEs after week 4, Step 1|2.0|||||TWO_SIDED|90.0|0.0|5.0|||||||Confidence intervals were Exact Clopper-Pearson.|5|0|
72352414|NCT02717494|144224368|OTHER||% with grade 4+ AEs, after week 4 Step 1|3.0|||||TWO_SIDED|90.0|1.0|8.0|||||Confidence intervals were Exact Clopper-Pearson.|||8|1|
72352415|NCT02717494|144224368|OTHER||% with Grade 3+ related to treatment|1.0|||||TWO_SIDED|90.0|0.0|4.0|||||Confidence intervals were Exact Clopper-Pearson.|||4|0|
72352416|NCT02717494|144224368|OTHER||% with Grade 3+ related to treatment|1.0|||||TWO_SIDED|90.0|0.0|4.0|||||Confidence intervals were Exact Clopper-Pearson.|||4|0|
72352417|NCT02717494|144224368|OTHER||% with Grade 3+ related to treatment|1.0|||||TWO_SIDED|90.0|0.0|4.0|||||Confidence intervals were Exact Clopper-Pearson.|||4|0|
72352418|NCT02717494|144224369|OTHER||% with grade 3+ AEs, up to week 4 Step 2|0.0|||||TWO_SIDED|90.0|0.0|5.0|||||Confidence intervals were Exact Clopper-Pearson.|||5|0|
72352419|NCT02717494|144224369|OTHER||% with grade 3+ AEs, up to week 4 Step 2|0.0|||||TWO_SIDED|90.0|0.0|5.0|||||Confidence intervals were Exact Clopper-Pearson.|||5|0|
72352420|NCT02717494|144224370|OTHER||% infants with grade 3+ AEs|21.0|||||TWO_SIDED|90.0|14.0|28.0|||||Confidence intervals were Exact Clopper-Pearson.|||28|14|
72352421|NCT02717494|144224370|OTHER||% infants with grade 3+ AEs|20.0|||||TWO_SIDED|90.0|14.0|27.0|||||||Confidence intervals were Exact Clopper-Pearson.|27|14|
72352422|NCT02717494|144224370|OTHER||% infants with grade 3+ AEs|20.0|||||TWO_SIDED|90.0|14.0|27.0|||||Confidence intervals were Exact Clopper-Pearson.|||27|14|
72352423|NCT02717494|144224370|OTHER||% infants with congenital anomalies|17.0|||||TWO_SIDED|90.0|11.0|24.0|||||||Confidence intervals were Exact Clopper-Pearson.|24|11|
72352424|NCT02717494|144224370|OTHER||% infants with congenital anomalies|22.0|||||TWO_SIDED|90.0|15.0|29.0|||||||Confidence intervals were Exact Clopper-Pearson.|29|15|
72352425|NCT02717494|144224370|OTHER||% infants with congenital anomalies|13.0|||||TWO_SIDED|90.0|8.0|19.0|||||Confidence intervals were Exact Clopper-Pearson.|||19|8|
72352426|NCT02717494|144224370|OTHER||% infants with HIV infection|0.0|||||TWO_SIDED|90.0|0.0|3.0|||||||Confidence intervals were Exact Clopper-Pearson.|3|0|
72352427|NCT02717494|144224370|OTHER||% infants with HIV infection|0.0|||||TWO_SIDED|90.0|0.0|3.0|||||Confidence intervals were Exact Clopper-Pearson.|||3|0|
72352428|NCT02717494|144224370|OTHER||% infants with HIV infection|0.0|||||TWO_SIDED|90.0|0.0|2.0|||||Confidence intervals were Exact Clopper-Pearson.|||2|0|
72352429|NCT02717494|144224370|OTHER||% with pneumonia, meningitis or IPD|4.0|||||TWO_SIDED|90.0|2.0|9.0|||||Confidence intervals were Exact Clopper-Pearson.|||9|2|
72352430|NCT02717494|144224370|OTHER||% with pneumonia, meningitis or IPD|7.0|||||TWO_SIDED|90.0|3.0|12.0|||||Confidence intervals were Exact Clopper-Pearson.|||12|3|
72352431|NCT02717494|144224370|OTHER||% with pneumonia, meningitis or IPD|7.0|||||TWO_SIDED|90.0|3.0|12.0|||||Confidence intervals were Exact Clopper-Pearson.|||12|3|
72352432|NCT02717494|144224371|SUPERIORITY|This is the test to compare the two vaccine arms with respect to proportion of participants with \>=2 fold increase at day 28.||||||0.44||||||The threshold for statistical significance is 0.05.|Fisher Exact|Fisher's exact test was used because 50% of the cells had expected counts less than 5.||||||0.44
72352433|NCT02717494|144224371|SUPERIORITY|This is the test to compare the two vaccine arms with respect to proportion of participants with values \>=0.35ug/mL at day 28.||||||0.49||||||The threshold for statistical significance is 0.05.|Fisher Exact|Fisher's exact test was used because 50% of the cells had expected counts less than 5.||||||0.49
72352434|NCT02717494|144224371|OTHER||% vaccinees with >=2fold increase|96.0|||||TWO_SIDED|95.0|91.0|99.0|||||Confidence intervals were Exact Clopper-Pearson.|||99|91|
72352435|NCT02717494|144224371|OTHER||% vaccinees with >=2fold increase|98.0|||||TWO_SIDED|95.0|94.0|100.0|||||Confidence intervals were Exact Clopper-Pearson.|||100|94|
72352436|NCT02717494|144224371|OTHER||% with >=2 fold increase|6.0|||||TWO_SIDED|95.0|3.0|12.0|||||Confidence intervals were Exact Clopper-Pearson.|||12|3|
72352437|NCT02717494|144224371|OTHER||% vaccinees with >=0.35ug/mL at day 28|99.0|||||TWO_SIDED|95.0|95.0|100.0|||||Confidence intervals were Exact Clopper-Pearson.|||100|95|
72352438|NCT02717494|144224371|OTHER||% vaccinees with >=0.35ug/mL at day 28|100.0|||||TWO_SIDED|95.0|97.0|100.0|||||Confidence intervals were Exact Clopper-Pearson.|||100|97|
72352439|NCT02717494|144224371|OTHER||% with >=0.35ug/mL at day 28|94.0|||||TWO_SIDED|95.0|88.0|97.0|||||Confidence intervals were Exact Clopper-Pearson.|||97|88|
72352440|NCT02717494|144224372|SUPERIORITY|||||||0.29||||||The threshold for statistical significance is 0.05.|Chi-squared|||||||0.29
72352441|NCT02717494|144224373|SUPERIORITY|||||||0.08||||||The threshold for statistical significance is 0.05.|t-test, 2 sided|||||||0.08
72352442|NCT02717494|144224374|SUPERIORITY|This is the test to compare the two vaccine arms with respect to proportion of participants with \>=2 fold increase at labor and delivery.||||||0.37||||||The threshold for statistical significance is 0.05.|Chi-squared|||||||0.37
72352443|NCT02717494|144224374|SUPERIORITY|This is the test to compare the two vaccine arms with respect to proportion of participants with \>=2 fold increase at 24 weeks post partum.||||||0.21|||||||Fisher Exact|Fisher's exact test was used because 50% of the cells had expected counts less than 5.||||||0.21
72352444|NCT02717494|144224375|OTHER||% vaccinees with >=2fold increase|96.0|||||TWO_SIDED|95.0|91.0|99.0||The threshold for statistical significance is 0.05.|||Confidence intervals were Exact Clopper-Pearson.|||99|91|
72352445|NCT02717494|144224375|OTHER||% vaccinees with >=2fold increase|98.0|||||TWO_SIDED|95.0|89.0|100.0|||||Confidence intervals were Exact Clopper-Pearson.|||100|89|
72352446|NCT02717494|144224376|OTHER||% vaccinees with >=2fold increase|98.0|||||TWO_SIDED|95.0|94.0|100.0|||||||Confidence intervals were Exact Clopper-Pearson.|100|94|
72352447|NCT02717494|144224376|OTHER||% vaccinees with >=2fold increase|100.0|||||TWO_SIDED|95.0|93.0|100.0|||||Confidence intervals were Exact Clopper-Pearson.|||100|93|
72352448|NCT02717494|144224377|OTHER||% infants with >=0.35ug/mL at week 16|100.0|||||TWO_SIDED|95.0|96.0|100.0|||||Confidence intervals were Exact Clopper-Pearson.|||100|96|
72352449|NCT02717494|144224377|OTHER||% infants with >=0.35ug/mL at week 16|98.0|||||TWO_SIDED|95.0|93.0|100.0|||||Confidence intervals were Exact Clopper-Pearson.|||100|93|
72352450|NCT02717494|144224377|OTHER||% infants with >=0.35ug/mL at week 16|97.0|||||TWO_SIDED|95.0|91.0|99.0|||||||Confidence intervals were Exact Clopper-Pearson.|99|91|
72352451|NCT02717494|144224377|OTHER||% infants with >=0.35ug/mL at week 24|100.0|||||TWO_SIDED|95.0|96.0|100.0|||||Confidence intervals were Exact Clopper-Pearson.|||100|96|
72352452|NCT02717494|144224377|OTHER||% infants with >=0.35ug/mL at week 24|99.0|||||TWO_SIDED|95.0|95.0|100.0|||||Confidence intervals were Exact Clopper-Pearson.|||100|95|
72352453|NCT02717494|144224377|OTHER||% infants with >=0.35ug/mL at week 24|98.0|||||TWO_SIDED|95.0|93.0|100.0|||||Confidence intervals were Exact Clopper-Pearson.|||100|93|
72352454|NCT04739436|144224379|SUPERIORITY||Slope|5.29||||0.003|TWO_SIDED|95.0|1.8|8.79||Multiple comparisons were not conducted, so no adjustment of the p-value was necessary.|Regression, Linear|||A linear regression model was fit with outcome change in APHAB score between 3 months and baseline, predictor hearing aid fitting group (reference=bilateral), and covariate clinical site.||8.79|1.80|0.003
72352455|NCT04739436|144224380|SUPERIORITY|||||||0.584||||||No adjustments for multiple comparisons were done.|Kruskal-Wallis|||The null hypothesis is there is no difference in the GHABP question means between the groups at 3 months for the question: In this situation, what proportion of the time do you wear your hearing aid?||||0.584
72352456|NCT04739436|144224380|SUPERIORITY|||||||0.233|||||||Kruskal-Wallis|||The null hypothesis is there is no difference in the GHABP question means between the groups at 3 months for the question: In this situation, how much does your hearing aid help you?||||0.233
72352457|NCT04739436|144224380|SUPERIORITY|||||||0.01|||||||Kruskal-Wallis|||The null hypothesis is there is no difference in the GHABP question means between the groups at 3 months for the question: In this situation, with your hearing aid, how much difficulty do you now have?||||0.010
72352458|NCT04739436|144224380|SUPERIORITY|||||||0.129|||||||Kruskal-Wallis|||The null hypothesis is there is no difference in the GHABP question means between the groups at 3 months for the question: For this situation, how satisfied are you with your hearing aid?||||0.129
72352459|NCT04739436|144224381|SUPERIORITY|||||||0.946|||||||Kruskal-Wallis|No adjustments for multiple comparisons were done.||The null hypothesis is there is no difference in the change from baseline to 3 months in the co-located BKB SIN test scores between the groups.||||0.946
72352460|NCT04739436|144224382|SUPERIORITY|||||||0.49|||||||Kruskal-Wallis|No adjustments for multiple comparisons were done.||The null hypotheses are there are no differences in the change from baseline to 3 months in WARRM recognition scores between the groups.||||0.490
72352461|NCT04739436|144224382|SUPERIORITY|||||||0.323||||||No adjustments for multiple comparisons were done.|t-test, 2 sided|||The null hypotheses are there are no differences in the change from baseline to 3 months in WARRM recall scores between the groups.||||0.323
72352462|NCT04739436|144224383|SUPERIORITY|||||||0.933||||||No adjustments for multiple comparisons were done.|t-test, 2 sided|||The null hypothesis is there is no difference in the SADL scores between the groups at 3 months.||||0.933
72352463|NCT04739436|144224383|SUPERIORITY|||||||0.929||||||No adjustments for multiple comparisons were done.|t-test, 2 sided|||The null hypothesis is there is no difference in the SADL scores between the groups at 6 months.||||0.929
72352464|NCT04739436|144224385|SUPERIORITY|||||||0.015|||||||t-test, 2 sided|||The null hypothesis is there is no difference in the change from baseline to 3 months in SSQ scores between the groups.||||0.015
72352465|NCT04739436|144224385|SUPERIORITY|||||||0.886|||||||t-test, 2 sided|No adjustments for multiple comparisons were done.||The null hypothesis is there is no difference in the change from baseline to 6 months in SSQ scores between the groups.||||0.886
72352466|NCT04739436|144224386|SUPERIORITY|||||||0.137|||||||t-test, 2 sided|No adjustments for multiple comparisons were done.||The null hypothesis is there is no difference in the number of hours of hearing aid use between the groups in the right ear.||||0.137
72352467|NCT04739436|144224386|SUPERIORITY|||||||0.612|||||||t-test, 2 sided|No adjustments for multiple comparisons were done.||The null hypothesis is there is no difference in the number of hours of hearing aid use between the groups in the left ear.||||0.612
72352468|NCT04739436|144224388|SUPERIORITY|||||||0.108|||||||t-test, 2 sided|No adjustments for multiple comparisons were done.||The null hypothesis is there is no difference in the IOI-HA total score between the groups at 3 months.||||0.108
72352469|NCT04739436|144224388|SUPERIORITY|||||||0.988||||||No adjustments for multiple comparisons were done.|t-test, 2 sided|||The null hypothesis is there is no difference in the IOI-HA total score between the groups at 6 months.||||0.988
72352470|NCT04739436|144224391|SUPERIORITY|||||||0.264|||||||t-test, 2 sided|No adjustments for multiple comparisons were done.||The null hypothesis is there is no difference in the change in APHAB score from baseline to 6 months between the groups.||||0.264
72352471|NCT00676013|144224392|OTHER|ANOVA and all pairwise comparisons using Tukey test.|Multiple pairwise comparisons|0.05||||0.05|TWO_SIDED|||||0.05 is a threshold for statistical significance.|ANOVA|||We conducted a multiple four group comparison (all pairwise comparisons were conducted). An Anova was conducted to assess statistical significance.|0.05|||0.05
72352472|NCT00428948|144224393|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.708|||<|0.0001|TWO_SIDED|95.0|-3.269|-2.147|||Linear mixed model||The variance of the random effect intercept was zero and resulted in a non-positive, definite variance-covariance matrix for the random effects.|The null hypothesis was that there was no difference in the percentage change per year in total kidney volume between the tolvaptan group and the placebo group.||-2.147|-3.269|<0.0001
72352473|NCT00428948|144224394|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.865||||0.0095|TWO_SIDED|95.0|0.775|0.965|||Recurrent event analysis||Tolvaptan divided by placebo.|The null hypothesis was that there was no difference in the ADPKD clinical progression events/100 follow-up years between the tolvaptan group and the placebo group.||0.965|0.775|0.0095
72352474|NCT00428948|144224395|SUPERIORITY_OR_OTHER||Difference in slope|0.977|||<|0.0001|TWO_SIDED|95.0|0.597|1.357|||Mixed Models Analysis|Derived from testing the time treatment interaction using linear mixed model in which both intercept and slope are fixed and random effects.||The null hypothesis was that there was no difference in the change in renal function per year between the tolvaptan group and the placebo group.||1.357|0.597|<0.0001
72352475|NCT00428948|144224396|SUPERIORITY_OR_OTHER||Difference in slope|-0.246||||0.552|TWO_SIDED|95.0|-1.059|0.566|||Mixed Models Analysis|Derived from testing the time treatment interaction using linear mixed model in which both intercept and slope are fixed and random effects.|Placebo minus tolvaptan.|The null hypothesis was that there was no difference in mean arterial blood pressure in non-hypertensive participants between the tolvaptan group and the placebo group.||0.566|-1.059|0.5520
72352476|NCT00428948|144224397|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.08||||0.1604|TWO_SIDED|95.0|-0.2|0.03|||ANCOVA|The analysis included baseline renal pain as a covariate.|Derived from ANCOVA with factors of treatment and baseline stratification factor interaction and covariate renal pain baseline.|The null hypothesis was that there was no difference in the change in renal pain between the tolvaptan group and the placebo group.||0.03|-0.20|0.1604
72352477|NCT00428948|144224398|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.996||||0.9704|TWO_SIDED|95.0|0.805|1.233|||Recurrent event analysis||Derived from rate and mean model of time to recurrent event analysis with factor treatment.|The null hypothesis was that there was no difference in the hypertensive events per 100 follow-up years in non-hypertensive participants between the tolvaptan group and the placebo group.||1.233|0.805|0.9704
72352478|NCT00428948|144224399|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.1||||0.7532|TWO_SIDED|95.0|0.602|2.017|||Cochran-Mantel-Haenszel||Tolvaptan divided by placebo.|The null hypothesis was that there was no difference in the percentage of participants with a clinically sustained decrease of blood pressure leading to a sustained reduction in antihypertensive therapy between the tolvaptan group and the placebo group.||2.017|0.602|0.7532
72352479|NCT02784171|144224439|SUPERIORITY|||||||0.0372|||||||Log Rank|||||||0.0372
72352480|NCT02360228|144224476|OTHER|||||||0.47|||||||ANOVA|Difference from day 5 to baseline was compared between the tACS, tDCS, and sham groups using a one way ANOVA. Degrees of freedom: df=19||The null hypothesis was that there is no difference between the changes in the AHRS score from baseline to 5 days between the groups.H0: μ1=μ2=μ3 μ1: mean(difference 5 days-baseline) for tACS group (n=8) μ2: mean(difference 5 days-baseline) for tDCS group (n=7) μ3: mean(difference 5 days-baseline) for sham group (n=7)||||0.47
72369503|NCT02039843|144249200|SUPERIORITY|||||||0.079||||||2-sided a priori alpha level was 0.05|Mixed Models Analysis|Linear mixed repeated measures analysis on group difference in PHQ-9 score adjusted for gender, site, baseline score, time, and timeXgroup||||||0.079
72352481|NCT02360228|144224478|OTHER|||||||0.37|||||||ANOVA|Difference from day 5 to baseline was compared between the tACS, tDCS, and sham using a one way ANOVA. Degrees of freedom: df=19||The null hypothesis was that there is no difference between the changes in the PANSS score from day 5 to baseline. H0: μ1=μ2=μ3 μ1: mean(difference 5 days-baseline) for tACS group (n=8) μ2: mean(difference 5 days-baseline) for tDCS group (n=7) μ3: mean(difference 5 days-baseline) for sham group (n=7)||||0.37
72352482|NCT02360228|144224479|OTHER|||||||0.11|||||||ANOVA|Difference from day 5 to baseline was compared between the tACS, tDCS, and sham groups using a one way ANOVA. Degrees of freedom: df=19||"The null hypothesis was that there is no difference between the changes in the BACS score from baseline to 5 days between the groups:~H0: μ1=μ2=μ3 μ1: mean(difference 5 days-baseline) for tACS group (n=8) μ2: mean(difference 5 days-baseline) for tDCS group (n=7) μ3: mean(difference 5 days-baseline) for sham group (n=7)"||||0.11
72352483|NCT04186871|144224493|SUPERIORITY|RESPONSE DIFFERENCE (95% CI) VS PLACEBO|Response Difference|-27.8|||||TWO_SIDED|95.0|-77.5|21.9||||||||21.9|-77.5|
72352484|NCT04186871|144224493|SUPERIORITY|ODDS RATIO (95% CI) VS PLACEBO|Odds Ratio (OR)|0.32||||0.3117|TWO_SIDED|95.0|0.04|2.73|||Cochran-Mantel-Haenszel|||||2.73|0.04|0.3117
72352485|NCT04186871|144224494|SUPERIORITY|ADJUSTED MEAN DIFFERENCE VS PLACEBO|Mean Difference (Final Values)|1.0|||||TWO_SIDED|95.0|-2.8|4.9||||||||4.9|-2.8|
72352486|NCT04186871|144224494|EQUIVALENCE|ADJUSTED MEAN DIFFERENCE AT WEEK 24|Mean Difference (Final Values)|-8.3|||||TWO_SIDED|95.0|-11.5|-5.0||||||||-5.0|-11.5|
72352487|NCT04186871|144224494|EQUIVALENCE|ADJUSTED MEAN DIFFERENCE AT WEEK 24|Mean Difference (Final Values)|-7.2|||||TWO_SIDED|95.0|-9.3|-5.2||||||||-5.2|-9.3|
72352488|NCT04186871|144224495|SUPERIORITY|RESPONSE DIFFERENCE VS PLACEBO|Response Difference|16.7|||||TWO_SIDED|95.0|-31.8|65.2||||||||65.2|-31.8|
72352489|NCT04186871|144224495|SUPERIORITY|ODDS RATIO VS PLACEBO|Odds Ratio (OR)|2.0|||||TWO_SIDED|95.0|0.22|18.04||||||||18.04|0.22|
72352490|NCT04186871|144224496|SUPERIORITY|RESPONSE DIFFERENCE (95% CI) VS PLACEBO|Response Difference|-11.9|||||TWO_SIDED|95.0|-57.1|33.3||||||||33.3|-57.1|
72352491|NCT04186871|144224496|SUPERIORITY|ODDS RATIO (95% CI) VS PLACEBO|Odds Ratio (OR)|0.4||||0.593|TWO_SIDED|95.0|0.02|10.02|||Cochran-Mantel-Haenszel|||||10.02|0.02|0.5930
72352492|NCT04186871|144224497|SUPERIORITY|RESPONSE DIFFERENCE VS PLACEBO|Response Difference|-14.6|||||TWO_SIDED|95.0|-36.9|7.7||||||||7.7|-36.9|
72352493|NCT04186871|144224497|SUPERIORITY|ODDS RATIO VS PLACEBO|Odds Ratio (OR)|0.46||||0.1639|TWO_SIDED|95.0|0.15|1.39|||Chi-squared|||||1.39|0.15|0.1639
72352494|NCT04186871|144224498|EQUIVALENCE|ADJUSTED MEAN DIFFERENCE WEEK 12|Mean Difference (Final Values)|-1.61|||||TWO_SIDED|95.0|-2.11|-1.11||||||||-1.110|-2.110|
72352495|NCT04186871|144224498|EQUIVALENCE|ADJUSTED MEAN DIFFERENCE AT WEEK 12|Mean Difference (Final Values)|-1.567|||||TWO_SIDED|95.0|-1.855|-1.28||||||||-1.280|-1.855|
72352496|NCT04186871|144224498|SUPERIORITY|ADJUSTED MEAN DIFFERENCE VS PLACEBO|Mean Difference (Final Values)|0.043|||||TWO_SIDED|95.0|-0.534|0.62||||||||0.620|-0.534|
72352497|NCT04186871|144224499|EQUIVALENCE|ADJUSTED MEAN DIFFERENCE AT WEEK 12|Mean Difference (Final Values)|-1.741|||||TWO_SIDED|95.0|-2.256|-1.226||||||||-1.226|-2.256|
72352498|NCT04186871|144224499|EQUIVALENCE|ADJUSTED MEAN DIFFERENCE AT WEEK 12|Mean Difference (Final Values)|-1.698|||||TWO_SIDED|95.0|-1.998|-1.399||||||||-1.399|-1.998|
72352499|NCT04186871|144224499|SUPERIORITY|ADJUSTED MEAN DIFFERENCE VS PLACEBO|Mean Difference (Final Values)|0.043|||||TWO_SIDED|95.0|-0.553|0.639||||||||0.639|-0.553|
72352500|NCT04186871|144224500|EQUIVALENCE|ADJUSTED MEAN DIFFERENCE AT WEEK 12|Mean Difference (Final Values)|-19.495|||||TWO_SIDED|95.0|-24.861|-14.128||||||||-14.128|-24.861|
72352501|NCT04186871|144224500|EQUIVALENCE|ADJUSTED MEAN DIFFERENCE AT WEEK 12|Mean Difference (Final Values)|-18.767|||||TWO_SIDED|95.0|-21.848|-15.686||||||||-15.686|-21.848|
72352502|NCT04186871|144224500|SUPERIORITY|ADJUSTED MEAN DIFFERENCE VS PLACEBO|Mean Difference (Final Values)|0.728|||||TWO_SIDED|95.0|-5.463|6.919||||||||6.919|-5.463|
72352503|NCT04186871|144224501|EQUIVALENCE|ADJUSTED MEAN AT DIFFERENCE WEEK 12|Mean Difference (Final Values)|-19.2|||||TWO_SIDED|95.0|-24.3|-14.1||||||||-14.1|-24.3|
72352504|NCT04186871|144224501|EQUIVALENCE|ADJUSTED MEAN AT DIFFERENCE WEEK 12|Mean Difference (Final Values)|-18.5|||||TWO_SIDED|95.0|-21.4|-15.5||||||||-15.5|-21.4|
72352505|NCT04186871|144224501|SUPERIORITY|ADJUSTED MEAN DIFFERENCE VS PLACEBO|Mean Difference (Final Values)|0.7|||||TWO_SIDED|95.0|-5.2|6.6||||||||6.6|-5.2|
72352506|NCT04186871|144224502|SUPERIORITY|RESPONSE DIFFERENCE VS PLACEBO|Response Difference|-4.1|||||TWO_SIDED|95.0|-28.1|19.9||||||||19.9|-28.1|
72352507|NCT04186871|144224502|SUPERIORITY|ODDS RATIO VS PLACEBO|Odds Ratio (OR)|0.84|||||TWO_SIDED|95.0|0.31|2.32||||||||2.32|0.31|
72352508|NCT04186871|144224503|SUPERIORITY|RESPONSE DIFFERENCE VS PLACEBO|Response Difference|-6.5|||||TWO_SIDED|95.0|-22.8|9.9||||||||9.9|-22.8|
72352509|NCT04186871|144224503|SUPERIORITY|ODDS RATIO VS PLACEBO|Odds Ratio (OR)|0.51|||||TWO_SIDED|95.0|0.11|2.34||||||||2.34|0.11|
72352510|NCT03932760|144224537|OTHER|Mean differences at the tested timepoints between VCI and AC. Models were also examined with the covariates of medication use and pregnant/post-partum status.|Mean estimates by time|0.913|STANDARD_ERROR_OF_MEAN|1.085||0.612|TWO_SIDED|95.0|-1.228|3.055|||Mixed Models Analysis||Time was treated as a categorical variable to allow for non-linear change over time. We present group, time, and group\*time estimates and their associated SE and CIs below. AC group and baseline timepoint are the reference categories.|We used multilevel generalized mixed modeling under an intent-to-treat approach to compare the outcome measures of EPDS between group 1 (VCI) and Group 2 (AC) at 6 time points during pregnancy and postpartum controlling for screening EPDS score. We powered for the fixed effect of Intervention X Time using RMANOVA with alpha = 0.5, 6 time points, 0.3 for correlation between repeated measures, and a sample size of 192 total participants gives greater than 90% power to detect an effect size of 0.1.|"Overall test of significance for Fixed Effects. Higher EPDS scores signify worsened symptoms of depression. Time uses start of study as reference controlling for screen EPDS.~Group VCI (AC reference): F=0.260, p=0.612~Time (Baseline as reference): F=9.021, p\<0.001~Group\*Time: F=0.537, p=0.748~Estimates for group, time, and group\*time interactions~Group:~Estimate=0.913 (SE=1.085) \[CI LB=-1.228, UB=3.055\]~Time:~Post: estimate=-2.766 (0.853) \[-4.445, -1.087\]~2 months: estimate=-1.517 (0.862) \[-3.214, 0.180\]~4 months: estimate=-3.186 (0.862) \[-4.883, -1.489\]~6 months: estimate=-2.781 (0.872) \[-4.498, -1.065\]~8 months: estimate=-3.103 (0.872) \[-4.819, -1.386\]~Group\*Time:~Post: estimate=-1.157 (1.214) \[-3.547, 1.232\]~2 months: estimate=-1.361 (1.210) \[-3.742, 1.019\]~4 months: estimate= 0.183 (1.209) \[-2.196, 2.562\]~6 months: estimate=-0.508 (1.223) \[-2.914, 1.898\]~8 months: estimate=-0.127 (1.220) \[-2.529, 2.275\]"|3.055|-1.228|0.612
72369504|NCT02039843|144249201|SUPERIORITY|||||||0.155||||||2-sided a priori alpha level was 0.05|Mixed Models Analysis|Linear mixed repeated measures analysis on group difference in DAR score adjusted for gender, site, baseline score, time, and timeXgroup||||||0.155
72352511|NCT03932760|144224538|OTHER|Mean differences at the tested timepoints between VCI and AC. Models were also examined with the covariates of medication use and pregnant/post-partum status.|Mean estimates by time|0.016|STANDARD_ERROR_OF_MEAN|0.859||0.558|TWO_SIDED|95.0|-1.709|1.677|||Mixed Models Analysis||Time was treated as a categorical variable to allow for non-linear change over time. We present group, time, and group\*time estimates and their associated SE and CIs below. AC group and baseline timepoint are the reference categories.|We used multilevel generalized mixed modeling under an intent-to-treat approach to compare the outcome measures of GAD-7 between group 1 (VCI) and Group 2 (AC) at 6 time points during pregnancy and postpartum. We powered for the fixed effect of Intervention X Time using RMANOVA with alpha = 0.5, 6 time points, 0.3 for correlation between repeated measures, and a sample size of 192 total participants gives greater than 90% power to detect an effect size of 0.1.|"Overall test of significance for Fixed Effects. Higher GAD-7 scores signify worsened symptoms of depression.~Group VCI (AC reference): F=0.347, p=0.558~Time (Baseline as reference): F=4.973, p\<0.001~Group\*Time: F=0.417, p=0.837~Estimates for group, time, and group\*time interactions~Group:~Estimate=-0.0160 (SE=0.859) \[CI LB=-1.709, UB=1.677\]~Time:~Post: estimate=-1.780 (0.708) \[-3.173, -0.387\]~2 months: estimate=-0.615 (0.715) \[-2.023, 0.792\]~4 months: estimate=-1.416 (0.715) \[-2.824, -0.008\]~6 months: estimate=-1.625 (0.723) \[-3.049, -0.201\]~8 months: estimate=-1.542 (0.723) \[-2.966, -0.118\]~Group\*Time:~Post: estimate=-1.157 (1.214) \[-3.547, 1.232\]~2 months: estimate=-1.361 (1.210) \[-3.742, 1.019\]~4 months: estimate= 0.183 (1.209) \[-2.196, 2.562\]~6 months: estimate=-0.508 (1.223) \[-2.914, 1.898\]~8 months: estimate=-0.127 (1.220) \[-2.529, 2.275\]"|1.677|-1.709|0.558
72352512|NCT00669214|144224559|SUPERIORITY_OR_OTHER||Difference in proportion|0.163||||0.1054||95.0|-0.063|0.393|||Fisher Exact|The p-value was based on the Fisher exact test for a 2x2 contingency table.||||0.393|-0.063|0.1054
72352513|NCT00669214|144224561|SUPERIORITY_OR_OTHER||Difference in proportion|0.155||||0.2404||95.0|-0.072|0.388|||Fisher Exact|The p-value was based on the Fisher exact test for a 2x2 contingency table.||||0.388|-0.072|0.2404
72352514|NCT00669214|144224563|SUPERIORITY_OR_OTHER||Difference in proportion|0.228||||0.0366||95.0|0.003|0.452|||Fisher Exact|The p-value was based on the Fisher exact test for a 2x2 contingency table.||||0.452|0.003|0.0366
72352515|NCT00669214|144224565|SUPERIORITY_OR_OTHER||Difference in mean change from Day 0|3.33||||0.1816||95.0|-2.811|9.471|||Student T-test|||||9.471|-2.811|0.1816
72352516|NCT00669214|144224567|SUPERIORITY_OR_OTHER||Difference in mean change from Day 0|1.19||||0.0435||95.0|-0.161|2.532|||Student T-test|||||2.532|-0.161|0.0435
72352517|NCT00669214|144224569|SUPERIORITY_OR_OTHER|||||||0.0224||95.0|||||Wilcoxon rank sum|||||||0.0224
72352518|NCT00754377|144224572|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED||||||t-test, 2 sided|||||||0.02
72352519|NCT00754377|144224573|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED||||||t-test, 2 sided|||||||0.001
72352520|NCT01276639|144224574|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.46|||<|0.0001|TWO_SIDED|95.0|4.4|15.03||Cochran-Mantel-Haenszel statistics adjusted for pooled investigator sites was used for the analysis. Each hypothesis was tested against placebo at significance level of 0.05 (2-sided).|Cochran-Mantel-Haenszel|||For primary endpoint, step-down procedure used to preserve Type I error, sequential order of testing: PGA response for CP-690,550 10 mg versus (vs) placebo at Week 16; Psoriasis Area and Severity Index 75 (PASI75) response for CP-690,550 10 mg vs placebo at Week 16; PGA response for CP-690,550 5 mg vs placebo at Week 16; PASI75 response for CP-690,550 5 mg vs placebo at Week 16. If comparison at preceding step was significant, only then subsequent comparisons were significant.||15.03|4.40|<0.0001
72352521|NCT01276639|144224574|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|12.45|||<|0.0001|TWO_SIDED|95.0|9.01|31.88||Cochran-Mantel-Haenszel statistics adjusted for pooled investigator sites was used for the analysis. Each hypothesis was tested against placebo at significance level of 0.05 (2-sided).|Cochran-Mantel-Haenszel|||For primary endpoint, step-down procedure used to preserve Type I error, sequential order of testing: PGA response for CP-690,550 10 mg versus (vs) placebo at Week 16; Psoriasis Area and Severity Index 75 (PASI75) response for CP-690,550 10 mg vs placebo at Week 16; PGA response for CP-690,550 5 mg vs placebo at Week 16; PASI75 response for CP-690,550 5 mg vs placebo at Week 16. If comparison at preceding step was significant, only then subsequent comparisons were significant.||31.88|9.01|<0.0001
72352522|NCT01276639|144224574|SUPERIORITY_OR_OTHER||Percent difference|17.29|STANDARD_ERROR_OF_MEAN|3.66|<|0.0001|TWO_SIDED|95.0|10.11|24.47|||Normal approximation|||||24.47|10.11|<0.0001
72352523|NCT01276639|144224575|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|8.93|||<|0.0001|TWO_SIDED|95.0|5.25|21.84||Cochran-Mantel-Haenszel statistics adjusted for pooled investigator sites was used for the analysis. Each hypothesis was tested against placebo at significance level of 0.05 (2-sided).|Cochran-Mantel-Haenszel|||For primary endpoint, step-down procedure used to preserve Type I error, sequential order of testing: PGA response for CP-690,550 10 mg versus (vs) placebo at Week 16; Psoriasis Area and Severity Index 75 (PASI75) response for CP-690,550 10 mg vs placebo at Week 16; PGA response for CP-690,550 5 mg vs placebo at Week 16; PASI75 response for CP-690,550 5 mg vs placebo at Week 16. If comparison at preceding step was significant, only then subsequent comparisons were significant.||21.84|5.25|<0.0001
72352524|NCT01276639|144224575|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|20.81|||<|0.0001|TWO_SIDED|95.0|11.9|49.86||Cochran-Mantel-Haenszel statistics adjusted for pooled investigator sites was used for the analysis. Each hypothesis was tested against placebo at significance level of 0.05 (2-sided).|Cochran-Mantel-Haenszel|||For primary endpoint, step-down procedure used to preserve Type I error, sequential order of testing: PGA response for CP-690,550 10 mg versus (vs) placebo at Week 16; Psoriasis Area and Severity Index 75 (PASI75) response for CP-690,550 10 mg vs placebo at Week 16; PGA response for CP-690,550 5 mg vs placebo at Week 16; PASI75 response for CP-690,550 5 mg vs placebo at Week 16. If comparison at preceding step was significant, only then subsequent comparisons were significant.||49.86|11.90|<0.0001
72352525|NCT01276639|144224575|SUPERIORITY_OR_OTHER||Percent difference|19.22|STANDARD_ERROR_OF_MEAN|3.65|<|0.0001|TWO_SIDED|95.0|12.07|26.37|||Normal approximation|||||26.37|12.07|<0.0001
72369505|NCT02039843|144249202|SUPERIORITY|||||||0.157||||||2-sided a priori alpha level was 0.05|Mixed Models Analysis|Generalized linear mixed repeated measures analysis on group difference in SBI adjusted for gender, site, baseline SBI, time, and timeXgroup||||||0.157
72369506|NCT02039843|144249203|SUPERIORITY|||||||0.43||||||p-value from random effects regression controlling for month and baseline outcome|Regression, Linear|||||||0.430
72369507|NCT02039843|144249204|SUPERIORITY|||||||0.358||||||p-value from random effects regression controlling for month and baseline outcome|Regression, Linear|||||||0.358
72352526|NCT01276639|144224576|SUPERIORITY_OR_OTHER||Least squares (LS) mean difference|-53.56|STANDARD_ERROR_OF_MEAN|4.34|<|0.0001|TWO_SIDED|95.0|-62.08|-45.04||Mixed model analysis with fixed effects for treatment, visit, treatment-by-visit interaction,baseline value and repeated measures for visit. Unstructured covariance matrix was used. Each hypothesis was tested at significance level of 0.025 (2-sided).|Mixed Models Analysis|||For key secondary endpoint, family-wise step-down procedure was used to control Type I error. Sequential order of testing: percent change in BSA at Week 16,PASI90 response at Week 16, change in Dermatology Life Quality Index(DLQI) total score at Week 16,PGA response at Week 4,PASI75 at Week 4, change in DLQI total score at Week 4, percent change in Nail Psoriasis Severity Index(NAPSI) score at Week 16. If comparison at preceding step was significant, then subsequent comparisons were significant.||-45.04|-62.08|<0.0001
72352527|NCT01276639|144224576|SUPERIORITY_OR_OTHER||LS mean difference|-68.82|STANDARD_ERROR_OF_MEAN|4.34|<|0.0001|TWO_SIDED|95.0|-77.33|-60.31||Mixed model analysis with fixed effects for treatment, visit, treatment-by-visit interaction,baseline value and repeated measures for visit. Unstructured covariance matrix was used. Each hypothesis was tested at significance level of 0.025 (2-sided).|Mixed Models Analysis|||For key secondary endpoint, family-wise step-down procedure was used to control Type I error. Sequential order of testing: percent change in BSA at Week 16,PASI90 response at Week 16, change in Dermatology Life Quality Index(DLQI) total score at Week 16,PGA response at Week 4,PASI75 at Week 4, change in DLQI total score at Week 4, percent change in Nail Psoriasis Severity Index(NAPSI) score at Week 16. If comparison at preceding step was significant, then subsequent comparisons were significant.||-60.31|-77.33|<0.0001
72352528|NCT01276639|144224576|SUPERIORITY_OR_OTHER||LS mean difference|-15.26|STANDARD_ERROR_OF_MEAN|3.46|<|0.0001|TWO_SIDED|95.0|-22.04|-8.48|||Mixed Models Analysis|||LS mean difference was derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction, baseline value and repeated measures for visit. Unstructured covariance matrix was used.||-8.48|-22.04|<0.0001
72352529|NCT01276639|144224577|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|34.55|||<|0.0001|TWO_SIDED|95.0|7.46|1786.9||Cochran-Mantel-Haenszel statistics adjusted for pooled investigator sites was used for the analysis. Each hypothesis was tested at significance level of 0.025 (2-sided).|Cochran-Mantel-Haenszel|||For key secondary endpoint, family-wise step-down procedure was used to control Type I error. Sequential order of testing: percent change in BSA at Week 16, PASI90 response at Week 16, change in DLQI total score at Week 16, PGA response at Week 4, PASI75 response at Week 4, change in DLQI total score at Week 4, percent change in NAPSI score at Week 16. If comparison at preceding step was significant, then subsequent comparisons were significant.||1786.9|7.46|<0.0001
72352530|NCT01276639|144224577|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|98.05|||<|0.0001|TWO_SIDED|95.0|23.49|5689.8||Cochran-Mantel-Haenszel statistics adjusted for pooled investigator sites was used for the analysis. Each hypothesis was tested at significance level of 0.025 (2-sided).|Cochran-Mantel-Haenszel|||For key secondary endpoint, family-wise step-down procedure was used to control Type I error. Sequential order of testing: percent change in BSA at Week 16, PASI90 response at Week 16, change in DLQI total score at Week 16, PGA response at Week 4, PASI75 response at Week 4, change in DLQI total score at Week 4, percent change in NAPSI score at Week 16. If comparison at preceding step was significant, then subsequent comparisons were significant.||5689.8|23.49|<0.0001
72352531|NCT01276639|144224577|SUPERIORITY_OR_OTHER||Percent difference|19.61|STANDARD_ERROR_OF_MEAN|3.32|<|0.0001|TWO_SIDED|95.0|13.1|26.11|||Normal approximation|||||26.11|13.10|<0.0001
72352532|NCT01276639|144224579|SUPERIORITY_OR_OTHER||LS mean difference|-3.9|STANDARD_ERROR_OF_MEAN|0.43|<|0.0001|TWO_SIDED|95.0|-4.75|-3.05||Mixed model analysis with fixed effects for treatment, visit, treatment-by-visit interaction,baseline value and repeated measures for visit. Unstructured covariance matrix was used. Each hypothesis was tested at significance level of 0.025 (2-sided).|Mixed Models Analysis|||Week4: For key secondary endpoint, family-wise step-down procedure was used to control Type I error. Sequential order of testing: percent change in BSA at Week 16, PASI90 response at Week 16, change in DLQI total score at Week 16, PGA response at Week 4, PASI75 response at Week 4, change in DLQI total score at Week 4, percent change in NAPSI score at Week 16. If comparison at preceding step was significant, then subsequent comparisons were significant.||-3.05|-4.75|<0.0001
72352533|NCT01276639|144224579|SUPERIORITY_OR_OTHER||LS mean difference|-4.71|STANDARD_ERROR_OF_MEAN|0.43|<|0.0001|TWO_SIDED|95.0|-5.56|-3.86||Mixed model analysis with fixed effects for treatment, visit, treatment-by-visit interaction,baseline value and repeated measures for visit. Unstructured covariance matrix was used. Each hypothesis was tested at significance level of 0.025 (2-sided).|Mixed Models Analysis|||Week 4: For key secondary endpoint, family-wise step-down procedure was used to control Type I error. Sequential order of testing: percent change in BSA at Week 16, PASI90 response at Week 16, change in DLQI total score at Week 16, PGA response at Week 4, PASI75 response at Week 4, change in DLQI total score at Week 4, percent change in NAPSI score at Week 16. If comparison at preceding step was significant, then subsequent comparisons were significant.||-3.86|-5.56|<0.0001
72352534|NCT01276639|144224579|SUPERIORITY_OR_OTHER||LS mean difference|-0.81|STANDARD_ERROR_OF_MEAN|0.35||0.0212|TWO_SIDED|95.0|-1.5|-0.12|||Mixed Models Analysis|||Week 4: LS mean difference was derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction, baseline value and repeated measures for visit. Unstructured covariance matrix was used.||-0.12|-1.50|0.0212
72352535|NCT01276639|144224579|SUPERIORITY_OR_OTHER||LS mean difference|-4.98|STANDARD_ERROR_OF_MEAN|0.53|<|0.0001|TWO_SIDED|95.0|-6.02|-3.95||Mixed model analysis with fixed effects for treatment, visit, treatment-by-visit interaction,baseline value and repeated measures for visit. Unstructured covariance matrix was used. Each hypothesis was tested at significance level of 0.025 (2-sided).|Mixed Models Analysis|||Week 16: For key secondary endpoint, family-wise step-down procedure was used to control Type I error. Sequential order of testing: percent change in BSA at Week 16, PASI90 response at Week 16, change in DLQI total score at Week 16, PGA response at Week 4, PASI75 response at Week 4, change in DLQI total score at Week 4, percent change in NAPSI score at Week 16. If comparison at preceding step was significant, then subsequent comparisons were significant.||-3.95|-6.02|<0.0001
72369508|NCT02039843|144249205|SUPERIORITY|||||||0.39||||||p-value from random effects regression controlling for month and baseline outcome|Regression, Linear|||||||0.39
72369509|NCT02039843|144249215|SUPERIORITY|||||||0.383||||||p-value from random effects regression controlling for month and baseline outcome|Regression, Linear|||||||0.383
72369510|NCT02039843|144249216|SUPERIORITY|||||||0.932|||||||Regression, Linear|||||||0.932
72352536|NCT01276639|144224579|SUPERIORITY_OR_OTHER||LS mean difference|-6.97|STANDARD_ERROR_OF_MEAN|0.53|<|0.0001|TWO_SIDED|95.0|-8.0|-5.94||Mixed model analysis with fixed effects for treatment, visit, treatment-by-visit interaction,baseline value and repeated measures for visit. Unstructured covariance matrix was used. Each hypothesis was tested at significance level of 0.025 (2-sided).|Mixed Models Analysis|||Week 16: For key secondary endpoint, family-wise step-down procedure was used to control Type I error. Sequential order of testing: percent change in BSA at Week 16, PASI90 response at Week 16, change in DLQI total score at Week 16, PGA response at Week 4, PASI75 response at Week 4, change in DLQI total score at Week 4, percent change in NAPSI score at Week 16. If comparison at preceding step was significant, then subsequent comparisons were significant.||-5.94|-8.00|<0.0001
72352537|NCT01276639|144224579|SUPERIORITY_OR_OTHER||LS mean difference|-1.99|STANDARD_ERROR_OF_MEAN|0.42|<|0.0001|TWO_SIDED|95.0|-2.8|-1.17|||Mixed Models Analysis|||Week 16: LS mean difference was derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction, baseline value and repeated measures for visit. Unstructured covariance matrix was used.||-1.17|-2.80|<0.0001
72352538|NCT01276639|144224580|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|8.34|||<|0.0001|TWO_SIDED|95.0|3.23|35.12||Cochran-Mantel-Haenszel statistics adjusted for pooled investigator sites was used for the analysis. Each hypothesis was tested at significance level of 0.025 (2-sided).|Cochran-Mantel-Haenszel|||For key secondary endpoint, family-wise step-down procedure was used to control Type I error. Sequential order of testing: percent change in BSA at Week 16, PASI90 response at Week 16, change in DLQI total score at Week 16, PGA response at Week 4, PASI75 response at Week 4, change in DLQI total score at Week 4, percent change in NAPSI score at Week 16. If comparison at preceding step was significant, then subsequent comparisons were significant.||35.12|3.23|<0.0001
72352539|NCT01276639|144224580|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|11.53|||<|0.0001|TWO_SIDED|95.0|5.06|54.42||Cochran-Mantel-Haenszel statistics adjusted for pooled investigator sites was used for the analysis. Each hypothesis was tested at significance level of 0.025 (2-sided).|Cochran-Mantel-Haenszel|||For key secondary endpoint, family-wise step-down procedure was used to control Type I error. Sequential order of testing: percent change in BSA at Week 16, PASI90 response at Week 16, change in DLQI total score at Week 16, PGA response at Week 4, PASI75 response at Week 4, change in DLQI total score at Week 4, percent change in NAPSI score at Week 16. If comparison at preceding step was significant, then subsequent comparisons were significant.||54.42|5.06|<0.0001
72352540|NCT01276639|144224580|SUPERIORITY_OR_OTHER||Percent difference|5.98|STANDARD_ERROR_OF_MEAN|2.97||0.0443|TWO_SIDED|95.0|0.15|11.8|||Normal approximation|||||11.80|0.15|0.0443
72352541|NCT01276639|144224581|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.76||||0.0003|TWO_SIDED|95.0|2.11|35.77||Cochran-Mantel-Haenszel statistics adjusted for pooled investigator sites was used for the analysis. Each hypothesis was tested at significance level of 0.025 (2-sided).|Cochran-Mantel-Haenszel|||For key secondary endpoint, family-wise step-down procedure was used to control Type I error. Sequential order of testing: percent change in BSA at Week 16, PASI90 response at Week 16, change in DLQI total score at Week 16, PGA response at Week 4, PASI75 response at Week 4, change in DLQI total score at Week 4, percent change in NAPSI score at Week 16. If comparison at preceding step was significant, then subsequent comparisons were significant.||35.77|2.11|0.0003
72352542|NCT01276639|144224581|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|11.55|||<|0.0001|TWO_SIDED|95.0|3.64|59.98||Cochran-Mantel-Haenszel statistics adjusted for pooled investigator sites was used for the analysis. Each hypothesis was tested at significance level of 0.025 (2-sided).|Cochran-Mantel-Haenszel|||For key secondary endpoint, family-wise step-down procedure was used to control Type I error. Sequential order of testing: percent change in BSA at Week 16, PASI90 response at Week 16, change in DLQI total score at Week 16, PGA response at Week 4, PASI75 response at Week 4, change in DLQI total score at Week 4, percent change in NAPSI score at Week 16. If comparison at preceding step was significant, then subsequent comparisons were significant.||59.98|3.64|<0.0001
72352543|NCT01276639|144224581|SUPERIORITY_OR_OTHER||Percent difference|5.09|STANDARD_ERROR_OF_MEAN|2.5||0.0415|TWO_SIDED|95.0|0.19|9.98|||Normal approximation|||||9.98|0.19|0.0415
72352544|NCT01276639|144224582|SUPERIORITY_OR_OTHER||LS mean difference|-69.7|STANDARD_ERROR_OF_MEAN|17.6|<|0.0001|TWO_SIDED|95.0|-104.27|-35.13||Mixed model analysis with fixed effects for treatment, visit, treatment-by-visit interaction,baseline value and repeated measures for visit. Unstructured covariance matrix was used. Each hypothesis was tested at significance level of 0.025 (2-sided).|Mixed Models Analysis|||For key secondary endpoint, family-wise step-down procedure was used to control Type I error. Sequential order of testing: percent change in BSA at Week 16, PASI90 response at Week 16, change in DLQI total score at Week 16, PGA response at Week 4, PASI75 response at Week 4, change in DLQI total score at Week 4, percent change in NAPSI score at Week 16. If comparison at preceding step was significant, then subsequent comparisons were significant.||-35.13|-104.27|<0.0001
72352545|NCT01276639|144224582|SUPERIORITY_OR_OTHER||LS mean difference|-97.03|STANDARD_ERROR_OF_MEAN|17.47|<|0.0001|TWO_SIDED|95.0|-131.35|-62.72||Mixed model analysis with fixed effects for treatment, visit, treatment-by-visit interaction,baseline value and repeated measures for visit. Unstructured covariance matrix was used. Each hypothesis was tested at significance level of 0.025 (2-sided).|Mixed Models Analysis|||For key secondary endpoint, family-wise step-down procedure was used to control Type I error. Sequential order of testing: percent change in BSA at Week 16, PASI90 response at Week 16, change in DLQI total score at Week 16, PGA response at Week 4, PASI75 response at Week 4, change in DLQI total score at Week 4, percent change in NAPSI score at Week 16. If comparison at preceding step was significant, then subsequent comparisons were significant.||-62.72|-131.35|<0.0001
72352546|NCT01276639|144224582|SUPERIORITY_OR_OTHER||LS mean difference|-27.33|STANDARD_ERROR_OF_MEAN|13.22||0.0391|TWO_SIDED|95.0|-53.29|-1.37|||Mixed Models Analysis|||LS mean difference was derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction, baseline value and repeated measures for visit. Unstructured covariance matrix was used.||-1.37|-53.29|0.0391
72352547|NCT01276639|144224586|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Log Rank|||||||<0.0001
72352548|NCT01276639|144224586|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Log Rank|||||||<0.0001
72352549|NCT01276639|144224586|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Log Rank|||||||<0.0001
72352550|NCT01276639|144224587|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Log Rank|||||||<0.0001
72352551|NCT01276639|144224587|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Log Rank|||||||<0.0001
72352552|NCT01276639|144224587|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Log Rank|||||||<0.0001
72352553|NCT01276639|144224588|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Log Rank|||||||<0.0001
72352554|NCT01276639|144224588|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Log Rank|||||||<0.0001
72352555|NCT01276639|144224588|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Log Rank|||||||<0.0001
72352556|NCT03726489|144224643|NON_INFERIORITY|Statistical inference was based on non-inferiority principles using a non-inferiority margin of 15%.|Risk Difference (RD)|7.2|||<|0.001|TWO_SIDED|95.0|0.8|13.5||P-value was not adjusted for multiple comparisons. All p-values below 0.001 are reported as \<0.001.|Marginal standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Overall analysis including all skin phototypes||13.5|0.8|<0.001
72352557|NCT03726489|144224643|NON_INFERIORITY|Statistical inference was based on non-inferiority principles using a non-inferiority margin of 15%.|Risk Difference (RD)|4.2|||<|0.001|TWO_SIDED|95.0|-5.4|13.8||P-value was not adjusted for multiple comparisons. All p-values below 0.001 are reported as \<0.001.|Marginal standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Analysis for Phototypes I/II||13.8|-5.4|<0.001
72352558|NCT03726489|144224643|NON_INFERIORITY|Statistical inference was based on non-inferiority principles using a non-inferiority margin of 15%.|Risk Difference (RD)|7.4|||<|0.001|TWO_SIDED|95.0|-2.2|17.0||P-value was not adjusted for multiple comparisons. All p-values below 0.001 are reported as \<0.001.|Marginal standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Analysis for Phototypes III/IV||17.0|-2.2|<0.001
72352559|NCT03726489|144224643|NON_INFERIORITY|Statistical inference was based on non-inferiority principles using a non-inferiority margin of 15%. The sample size for this subgroup did not meet our a priori sample size required for 80% power.|Risk Difference (RD)|18.7|||<|0.001|TWO_SIDED|95.0|0.8|36.6||P-value was not adjusted for multiple comparisons. All p-values below 0.001 are reported as \<0.001.|Marginal standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Analysis for Phototypes V/VI||36.6|0.8|<0.001
72352560|NCT03726489|144224643|OTHER|HTE was assessed using an omnibus Wald test of all interaction regression parameters in order to minimize multiple testing and consequent alpha inflation.||||||0.347||||||HTE was assessed using an omnibus Wald test of all interaction regression parameters in order to minimize multiple testing and consequent alpha inflation.|Regression, Logistic|We fit models for each of the two primary outcomes with skin type, treatment arm, and their interaction as predictors.||Analysis for heterogeneity of treatment effects (HTE) including all skin phototypes.||||0.347
72352561|NCT03726489|144224644|NON_INFERIORITY|Statistical inference was based on non-inferiority principles using a non-inferiority margin of 15%.|Risk Difference (RD)|18.6|||<|0.001|TWO_SIDED|95.0|11.8|25.3||P-value was not adjusted for multiple comparisons. All p-values below 0.001 are reported as \<0.001.|Marginal standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Overall analysis including all skin phototypes||25.3|11.8|<0.001
72352562|NCT03726489|144224644|NON_INFERIORITY|Statistical inference was based on non-inferiority principles using a non-inferiority margin of 15%.|Risk Difference (RD)|21.2|||<|0.001|TWO_SIDED|95.0|11.0|31.5||P-value was not adjusted for multiple comparisons. All p-values below 0.001 are reported as \<0.001.|Marginal standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Analysis for Phototypes I/II||31.5|11.0|<0.001
72352563|NCT03726489|144224644|NON_INFERIORITY|Statistical inference was based on non-inferiority principles using a non-inferiority margin of 15%.|Risk Difference (RD)|16.5|||<|0.001|TWO_SIDED|95.0|6.4|26.6||P-value was not adjusted for multiple comparisons. All p-values below 0.001 are reported as \<0.001.|Marginal standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Analysis for Phototypes III/IV||26.6|6.4|<0.001
72352564|NCT03726489|144224644|NON_INFERIORITY|Statistical inference was based on non-inferiority principles using a non-inferiority margin of 15%. The sample size for this subgroup did not meet our a priori sample size required for 80% power.|Risk Difference (RD)|16.1||||0.001|TWO_SIDED|95.0|-3.7|35.9||P-value was not adjusted for multiple comparisons. All p-values below 0.001 are reported as \<0.001.|Marginal standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Analysis for Phototypes V/VI||35.9|-3.7|0.001
72352565|NCT03726489|144224644|OTHER|||||||0.873||||||HTE was assessed using an omnibus Wald test of all interaction regression parameters in order to minimize multiple testing and consequent alpha inflation.|Regression, Logistic|We fit models for each of the two primary outcomes with skin type, treatment arm, and their interaction as predictors.||Analysis for heterogeneity of treatment effects (HTE) including all skin phototypes.||||0.873
72352566|NCT03726489|144224645|SUPERIORITY||Mean Difference (Final Values)|8.7|||<|0.0001|TWO_SIDED|95.0|7.1|10.4||P-value was not adjusted for multiple comparisons.|Regression, Linear|Adjusted for skin phototype||Overall analysis adjusted for all skin phototypes||10.4|7.1|<0.0001
72352567|NCT03726489|144224645|SUPERIORITY||Mean Difference (Final Values)|9.38|||<|0.0001|TWO_SIDED|95.0|7.05|11.71||P-value was not adjusted for multiple comparisons.|Regression, Linear|||Analysis for Phototypes I/II||11.71|7.05|<0.0001
72352568|NCT03726489|144224645|SUPERIORITY||Mean Difference (Final Values)|8.48|||<|0.0001|TWO_SIDED|95.0|5.82|11.14||P-value was not adjusted for multiple comparisons.|Regression, Linear|||Analysis for Phototypes III/IV||11.14|5.82|<0.0001
72352569|NCT03726489|144224645|SUPERIORITY||Mean Difference (Final Values)|6.82||||0.0213|TWO_SIDED|95.0|1.06|12.58||P-value was not adjusted for multiple comparisons.|Regression, Linear|||Analysis for Phototypes V/VI||12.58|1.06|0.0213
72352570|NCT03726489|144224646|SUPERIORITY||Mean Difference (Final Values)|14.6|||<|0.0001|TWO_SIDED|95.0|10.4|18.7||P-value was not adjusted for multiple comparisons.|Regression, Linear|Adjusted for skin phototype||Overall analysis adjusted for all skin phototypes||18.7|10.4|<0.0001
72352571|NCT03726489|144224646|SUPERIORITY||Mean Difference (Final Values)|11.47|||<|0.0001|TWO_SIDED|95.0|6.93|16.01||P-value was not adjusted for multiple comparisons.|Regression, Linear|||Analysis for Phototypes I/II||16.01|6.93|<0.0001
72352572|NCT03726489|144224646|SUPERIORITY||Mean Difference (Final Values)|13.87|||<|0.0001|TWO_SIDED|95.0|7.77|19.98||P-value was not adjusted for multiple comparisons.|Regression, Linear|||Analysis for Phototypes III/IV||19.98|7.77|<0.0001
72352573|NCT03726489|144224646|SUPERIORITY||Mean Difference (Final Values)|32.84||||0.0127|TWO_SIDED|95.0|7.32|58.35||P-value was not adjusted for multiple comparisons.|Regression, Linear|||Analysis for Phototypes V/VI||58.35|7.32|0.0127
72352574|NCT03726489|144224647|SUPERIORITY||Mean Difference (Final Values)|-0.81||||0.001|TWO_SIDED|95.0|-1.27|-0.35||P-value was not adjusted for multiple comparisons.|Regression, Linear|Adjusted for skin phototype||Overall analysis adjusted for all skin phototypes||-0.35|-1.27|0.001
72352575|NCT03726489|144224647|SUPERIORITY||Mean Difference (Final Values)|-0.84||||0.0158|TWO_SIDED|95.0|-1.51|-0.16||P-value was not adjusted for multiple comparisons.|Regression, Linear|||Analysis for Phototypes I/II||-0.16|-1.51|0.0158
72352576|NCT03726489|144224647|SUPERIORITY||Mean Difference (Final Values)|-0.88||||0.013|TWO_SIDED|95.0|-1.58|-0.19||P-value was not adjusted for multiple comparisons.|Regression, Linear|||Analysis for Phototypes III/IV||-0.19|-1.58|0.0130
72352577|NCT03726489|144224647|SUPERIORITY||Mean Difference (Final Values)|-0.41||||0.591|TWO_SIDED|95.0|-1.94|1.11||P-value was not adjusted for multiple comparisons.|Regression, Linear|||Analysis for Phototypes V/VI||1.11|-1.94|0.5910
72352578|NCT03726489|144224647|SUPERIORITY||Mean Difference (Final Values)|0.25||||0.395|TWO_SIDED|95.0|-0.33|0.82||P-value was not adjusted for multiple comparisons.|Regression, Linear|Adjusted for skin phototype||Overall analysis adjusted for all skin phototypes at Week 24||0.82|-0.33|0.395
72352579|NCT03726489|144224647|SUPERIORITY||Mean Difference (Final Values)|0.12||||0.774|TWO_SIDED|95.0|-0.69|0.93||P-value was not adjusted for multiple comparisons.|Regression, Linear|||Analysis for Phototypes I/II at Week 24||0.93|-0.69|0.774
72352580|NCT03726489|144224647|SUPERIORITY||Median Difference (Final Values)|0.53||||0.242|TWO_SIDED|95.0|-0.36|1.41||P-value was not adjusted for multiple comparisons.|Regression, Linear|||Analysis for Phototypes III/IV at Week 24||1.41|-0.36|0.242
72352581|NCT03726489|144224647|SUPERIORITY||Mean Difference (Final Values)|-0.44||||0.692|TWO_SIDED|95.0|-2.72|1.83||P-value was not adjusted for multiple comparisons.|Regression, Linear|||Analysis for Phototypes V/VI at Week 24||1.83|-2.72|0.692
72352582|NCT03726489|144224648|SUPERIORITY||Risk Difference (RD)|-2.59||||0.1209|TWO_SIDED|95.0|-5.86|0.68||P-value was not adjusted for multiple comparisons.|Marginal Standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Overall analysis adjusted for all skin phototypes - Initiation||0.68|-5.86|0.1209
72352583|NCT03726489|144224648|SUPERIORITY||Risk Difference (RD)|-2.13||||0.2581|TWO_SIDED|95.0|-6.0|1.75||P-value was not adjusted for multiple comparisons.|Marginal standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Analysis for Phototypes I/II - Initiation||1.75|-6.0|0.2581
72352584|NCT03726489|144224648|SUPERIORITY||Risk Difference (RD)|-3.04||||0.2952|TWO_SIDED|95.0|-8.73|2.65||P-value was not adjusted for multiple comparisons.|Marginal standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Analysis for Phototypes III/IV - Initiation||2.65|-8.73|0.2952
72352585|NCT03726489|144224648|SUPERIORITY||Risk Difference (RD)|-2.61||||0.6324|TWO_SIDED|95.0|-13.12|7.89||P-value was not adjusted for multiple comparisons.|Marginal standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Analysis for Phototypes V/VI - Initiation||7.89|-13.12|0.6324
72352586|NCT03726489|144224648|SUPERIORITY||Risk Difference (RD)|0.15||||0.9163|TWO_SIDED|95.0|-2.56|2.85||P-value was not adjusted for multiple comparisons.|Marginal standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Overall analysis adjusted for all skin phototypes - Discontinuation||2.85|-2.56|0.9163
72352587|NCT03726489|144224648|SUPERIORITY||Risk Difference (RD)|0.31||||0.8551|TWO_SIDED|95.0|-3.03|3.66||P-value was not adjusted for multiple comparisons.|Marginal Standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Analysis for Phototypes I/II - Discontinuation||3.66|-3.03|0.8551
72352588|NCT03726489|144224648|SUPERIORITY||Risk Difference (RD)|0.72||||0.7678|TWO_SIDED|95.0|-4.05|5.48||P-value was not adjusted for multiple comparisons.|Marginal standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Analysis for Phototypes III/IV - Discontinuation||5.48|-4.05|0.7678
72352589|NCT03726489|144224648|SUPERIORITY||Risk Difference (RD)|-3.03||||0.3446|TWO_SIDED|95.0|-8.88|2.82||P-value was not adjusted for multiple comparisons.|Marginal standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Analysis for Phototypes V/VI - Discontinuation||2.82|-8.88|0.3446
72352590|NCT03726489|144224648|SUPERIORITY||Risk Difference (RD)|-1.26||||0.5716|TWO_SIDED|95.0|-5.64|3.11||P-value was not adjusted for multiple comparisons.|Marginal Standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Overall analysis adjusted for all skin phototypes - Initiation at Week 24||3.11|-5.64|0.5716
72352591|NCT03726489|144224648|SUPERIORITY||Risk Difference (RD)|-0.44||||0.8756|TWO_SIDED|95.0|-6.03|5.14||P-value was not adjusted for multiple comparisons.|Marginal standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Analysis for Phototypes I/II - Initiation at Week 24||5.14|-6.03|0.8756
72352592|NCT03726489|144224648|SUPERIORITY||Risk Difference (RD)|-2.07||||0.5686|TWO_SIDED|95.0|-9.18|5.04||P-value was not adjusted for multiple comparisons.|Marginal standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Analysis for Phototypes III/IV - Initiation at Week 24||5.04|-9.18|0.5686
72352593|NCT03726489|144224648|SUPERIORITY||Risk Difference (RD)|-1.39||||0.866|TWO_SIDED|95.0|-17.5|14.7||P-value was not adjusted for multiple comparisons.|Marginal standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Analysis for Phototypes V/VI - Initiation at Week 24||14.7|-17.5|0.8660
72352594|NCT03726489|144224648|SUPERIORITY||Risk Difference (RD)|0.19||||0.8779|TWO_SIDED|95.0|-2.24|2.62||P-value was not adjusted for multiple comparisons.|Marginal standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Overall analysis adjusted for all skin phototypes - Discontinuation at Week 24||2.62|-2.24|0.8779
72352595|NCT03726489|144224648|SUPERIORITY||Risk Difference (RD)|0.38||||0.7985|TWO_SIDED|95.0|-2.52|3.28||P-value was not adjusted for multiple comparisons.|Marginal Standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Analysis for Phototypes I/II - Discontinuation at Week 24||3.28|-2.52|0.7985
72352596|NCT03726489|144224648|SUPERIORITY||Risk Difference (RD)|0.69||||0.7585|TWO_SIDED|95.0|-3.71|5.09||P-value was not adjusted for multiple comparisons.|Marginal standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Analysis for Phototypes III/IV - Discontinuation at Week 24||5.09|-3.71|0.7585
72352597|NCT03726489|144224648|SUPERIORITY||Risk Difference (RD)|-2.78||||0.3422|TWO_SIDED|95.0|-8.15|2.59||P-value was not adjusted for multiple comparisons.|Marginal standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Analysis for Phototypes V/VI - Discontinuation at Week 24||2.59|-8.15|0.3422
72352598|NCT03726489|144224649|SUPERIORITY||Mean Difference (Final Values)|-3.2||||0.094|TWO_SIDED|95.0|-6.95|0.55||P-value was not adjusted for multiple comparisons.|Regression, Linear|Adjusted for skin phototype||Overall analysis adjusted for all skin phototypes||0.55|-6.95|0.094
72352599|NCT03726489|144224649|SUPERIORITY||Mean Difference (Final Values)|-5.26||||0.0393|TWO_SIDED|95.0|-10.26|-0.26||P-value was not adjusted for multiple comparisons.|Regression, Linear|||Analysis for Phototypes I/II||-0.26|-10.26|0.0393
72352600|NCT03726489|144224649|SUPERIORITY||Mean Difference (Final Values)|-3.92||||0.1505|TWO_SIDED|95.0|-9.28|1.44||P-value was not adjusted for multiple comparisons.|Regression, Linear|||Analysis for Phototypes III/IV||1.44|-9.28|0.1505
72352601|NCT03726489|144224649|SUPERIORITY||Mean Difference (Final Values)|10.42||||0.284|TWO_SIDED|95.0|-9.0|29.84||P-value was not adjusted for multiple comparisons.|Regression, Linear|||Analysis for Phototypes V/VI||29.84|-9.0|0.2840
72352602|NCT03726489|144224650|OTHER||Mean|19.87|STANDARD_DEVIATION|61.6|||TWO_SIDED|||||P-value is not applicable.||||Overall analysis adjusted for all skin phototypes||||
72352603|NCT03726489|144224650|OTHER||Mean|18.06|STANDARD_DEVIATION|57.04|||TWO_SIDED|||||P-value is not applicable.||||Analysis for Phototypes I/II||||
72352604|NCT03726489|144224650|OTHER||Mean|23.46|STANDARD_DEVIATION|70.71|||TWO_SIDED|||||P-value is not applicable.||||Analysis for Phototypes III/IV||||
72352605|NCT03726489|144224650|OTHER||Mean|9.22|STANDARD_DEVIATION|5.66|||TWO_SIDED|||||P-value is not applicable.||||Analysis for Phototypes V/VI||||
72352606|NCT03726489|144224651|OTHER||Mean|50.3|STANDARD_DEVIATION|46.7|||TWO_SIDED|||||P-value is not applicable.||||Overall analysis adjusted for all skin phototypes||||
72352607|NCT03726489|144224651|OTHER||Mean|53.19|STANDARD_DEVIATION|50.05|||TWO_SIDED|||||P-value is not applicable.||||Analysis for Phototypes I/II||||
72352608|NCT03726489|144224651|OTHER||Mean|49.82|STANDARD_DEVIATION|47.43|||TWO_SIDED|||||P-value is not applicable.||||Analysis for Phototypes III/IV||||
72352609|NCT03726489|144224651|OTHER||Mean|39.72|STANDARD_DEVIATION|20.47|||TWO_SIDED|||||P-value is not applicable.||||Analysis for Phototypes V/VI||||
72352610|NCT03726489|144224652|NON_INFERIORITY|Statistical inference was based on non-inferiority principles using a non-inferiority margin of 15%.|Risk Difference (RD)|11.97|||<|0.0001|TWO_SIDED|95.0|6.52|17.42||P-value was not adjusted for multiple comparisons.|Marginal standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Overall analysis adjusted for all skin phototypes||17.42|6.52|<0.0001
72352611|NCT03726489|144224652|NON_INFERIORITY|Statistical inference was based on non-inferiority principles using a non-inferiority margin of 15%.|Risk Difference (RD)|16.15|||<|0.0001|TWO_SIDED|95.0|7.54|24.75||P-value was not adjusted for multiple comparisons.|Marginal standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Analysis for Phototypes I/II||24.75|7.54|<0.0001
72352612|NCT03726489|144224652|NON_INFERIORITY|Statistical inference was based on non-inferiority principles using a non-inferiority margin of 15%.|Risk Difference (RD)|5.56|||<|0.0001|TWO_SIDED|95.0|-2.35|13.46||P-value was not adjusted for multiple comparisons.|Marginal standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Analysis for Phototypes III/IV||13.46|-2.35|<0.0001
72352613|NCT03726489|144224652|NON_INFERIORITY|Statistical inference was based on non-inferiority principles using a non-inferiority margin of 15%.|Risk Difference (RD)|21.37|||<|0.0001|TWO_SIDED|95.0|7.65|35.09||P-value was not adjusted for multiple comparisons.|Marginal standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Analysis for Phototypes V/VI||35.09|7.65|<0.0001
72352614|NCT03726489|144224653|SUPERIORITY||Risk Difference (RD)|11.68||||0.0065|TWO_SIDED|95.0|3.27|20.08||P-value was not adjusted for multiple comparisons.|Marginal standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Overall analysis adjusted for all skin phototypes||20.08|3.27|0.0065
72352615|NCT03726489|144224653|SUPERIORITY||Risk Difference (RD)|12.31||||0.0478|TWO_SIDED|95.0|0.03|24.49||P-value was not adjusted for multiple comparisons.|Marginal standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Analysis for Phototypes I/II||24.49|0.03|0.0478
72352616|NCT03726489|144224653|SUPERIORITY||Risk Difference (RD)|13.25||||0.0431|TWO_SIDED|95.0|0.52|25.98||P-value was not adjusted for multiple comparisons.|Marginal standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Analysis for Phototypes III/IV||25.98|0.52|0.0431
72352617|NCT03726489|144224653|SUPERIORITY||Risk Difference (RD)|1.5||||0.9133|TWO_SIDED|95.0|-25.5|28.5||P-value was not adjusted for multiple comparisons.|Marginal standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Analysis for Phototypes V/VI||28.50|-25.50|0.9133
72352618|NCT03726489|144224654|SUPERIORITY||Mean Difference (Final Values)|-7.9||||0.048|TWO_SIDED|95.0|-15.73|-0.07||P-value was not adjusted for multiple comparisons.|Regression, Linear|Adjusted for skin phototype||Overall analysis adjusted for all skin phototypes||-0.07|-15.73|0.048
72352619|NCT03726489|144224654|SUPERIORITY||Mean Difference (Final Values)|-10.67||||0.1199|TWO_SIDED|95.0|-24.15|2.8||P-value was not adjusted for multiple comparisons.|Regression, Linear|||Analysis for Phototypes I/II||2.80|-24.15|0.1199
72352620|NCT03726489|144224654|SUPERIORITY||Mean Difference (Final Values)|-5.3||||0.2953|TWO_SIDED|95.0|-15.26|4.66||P-value was not adjusted for multiple comparisons.|Regression, Linear|||Analysis for Phototypes III/IV||4.66|-15.26|0.2953
72352621|NCT03726489|144224654|SUPERIORITY||Mean Difference (Final Values)|-8.83||||0.5124|TWO_SIDED|95.0|-35.77|18.11||P-value was not adjusted for multiple comparisons.|Regression, Linear|||Analysis for Phototypes V/VI||18.11|-35.77|0.5124
72352622|NCT03726489|144224655|SUPERIORITY||Risk Difference (RD)|10.9||||0.0173|TWO_SIDED|95.0|1.93|19.87||P-value was not adjusted for multiple comparisons.|Marginal standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Overall analysis adjusted for all skin phototypes||19.87|1.93|0.0173
72352623|NCT03726489|144224655|SUPERIORITY||Risk Difference (RD)|13.06||||0.0662|TWO_SIDED|95.0|-0.81|26.94||P-value was not adjusted for multiple comparisons.|Marginal standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Analysis for Phototypes I/II||26.94|-0.81|0.0662
72352624|NCT03726489|144224655|SUPERIORITY||Risk Difference (RD)|8.58||||0.1976|TWO_SIDED|95.0|-4.42|21.57||P-value was not adjusted for multiple comparisons.|Marginal standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Analysis for Phototypes III/IV||21.57|-4.42|0.1976
72352625|NCT03726489|144224655|SUPERIORITY||Risk Difference (RD)|13.04||||0.3595|TWO_SIDED|95.0|-14.6|40.69||P-value was not adjusted for multiple comparisons.|Marginal standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Analysis for Phototypes V/VI||40.69|-14.60|0.3595
72352626|NCT03726489|144224656|SUPERIORITY||Risk Difference (RD)|7.55||||0.0853|TWO_SIDED|95.0|-1.05|16.14||P-value was not adjusted for multiple comparisons.|Marginal standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Overall analysis adjusted for all skin phototypes||16.14|-1.05|0.0853
72352627|NCT03726489|144224656|SUPERIORITY||Risk Difference (RD)|2.26||||0.7488|TWO_SIDED|95.0|-11.54|16.06||P-value was not adjusted for multiple comparisons.|Marginal standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Analysis for Phototypes I/II||16.06|-11.54|0.7488
72352628|NCT03726489|144224656|SUPERIORITY||Risk Difference (RD)|10.12||||0.1051|TWO_SIDED|95.0|-2.03|22.26||P-value was not adjusted for multiple comparisons.|Marginal standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Analysis for Phototypes III/IV||22.26|-2.03|0.1051
72352629|NCT03726489|144224656|SUPERIORITY||Risk Difference (RD)|17.39||||0.1792|TWO_SIDED|95.0|-7.48|42.27||P-value was not adjusted for multiple comparisons.|Marginal standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Analysis for Phototypes V/VI||42.27|-7.48|0.1792
72352630|NCT03726489|144224657|SUPERIORITY||Mean Difference (Final Values)|3.07||||0.175|TWO_SIDED|95.0|-1.37|7.5||P-value was not adjusted for multiple comparisons.|Regression, Linear|Adjusted for skin phototype||Overall analysis adjusted for all skin phototypes||7.50|-1.37|0.175
72352631|NCT03726489|144224657|SUPERIORITY||Mean Difference (Final Values)|-0.41||||0.8904|TWO_SIDED|95.0|-6.34|5.51||P-value was not adjusted for multiple comparisons.|Regression, Linear|||Analysis for Phototypes I/II||5.51|-6.34|0.8904
72352632|NCT03726489|144224657|SUPERIORITY||Mean Difference (Final Values)|7.59||||0.0412|TWO_SIDED|95.0|0.31|14.88||P-value was not adjusted for multiple comparisons.|Regression, Linear|||Analysis for Phototypes III/IV||14.88|0.31|0.0412
72352633|NCT03726489|144224657|SUPERIORITY||Mean Difference (Final Values)|5.5||||0.5481|TWO_SIDED|95.0|-13.38|24.38||P-value was not adjusted for multiple comparisons.|Regression, Linear|||Analysis for Phototypes V/VI||24.38|-13.38|0.5481
72352634|NCT03726489|144224657|SUPERIORITY||Hazard Ratio (HR)|0.813||||0.458|TWO_SIDED|95.0|0.471|1.403|||Regression, Cox|Failure event corresponds to DLQI assessment greater than 5. Model adjusted for skin phototype.|Office phototherapy is the reference group.|Cox proportional hazards model for maintaining treatment response after week 12.||1.403|0.471|0.458
72352635|NCT03726489|144224658|SUPERIORITY||Risk Difference (RD)|38.1|||<|0.0001|TWO_SIDED|95.0|30.34|45.86||P-value was not adjusted for multiple comparisons.|Marginal Standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Overall analysis adjusted for all skin phototypes||45.86|30.34|<0.0001
72352636|NCT03726489|144224658|SUPERIORITY||Risk Difference (RD)|38.86|||<|0.0001|TWO_SIDED|95.0|27.39|50.33||P-value was not adjusted for multiple comparisons.|Marginal Standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Analysis for Phototypes I/II||50.33|27.39|<0.0001
72352637|NCT03726489|144224658|SUPERIORITY||Risk Difference (RD)|42.21|||<|0.0001|TWO_SIDED|95.0|30.73|53.68||P-value was not adjusted for multiple comparisons.|Marginal Standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Analysis for Phototypes III/IV||53.68|30.73|<0.0001
72352638|NCT03726489|144224658|SUPERIORITY||Risk Difference (RD)|15.74||||0.234|TWO_SIDED|95.0|-9.63|41.11||P-value was not adjusted for multiple comparisons.|Marginal Standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Analysis for Phototypes V/VI||41.11|-9.63|0.2340
72352639|NCT03726489|144224659|SUPERIORITY||Risk Difference (RD)|43.96|||<|0.0001|TWO_SIDED|95.0|37.25|50.66||P-value was not adjusted for multiple comparisons.|Marginal standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Overall analysis including all skin phototypes||50.66|37.25|<0.0001
72352640|NCT03726489|144224659|SUPERIORITY||Risk Difference (RD)|39.85|||<|0.0001|TWO_SIDED|95.0|30.0|49.7||P-value was not adjusted for multiple comparisons.|Marginal Standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Analysis for Phototypes I/II||49.70|30.0|<0.0001
72352641|NCT03726489|144224659|SUPERIORITY||Risk Difference (RD)|50.18|||<|0.0001|TWO_SIDED|95.0|40.09|60.27||P-value was not adjusted for multiple comparisons.|Marginal standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Analysis for Phototypes III/IV||60.27|40.09|<0.0001
72352642|NCT03726489|144224659|SUPERIORITY||Risk Difference (RD)|36.11|||<|0.0001|TWO_SIDED|95.0|14.35|57.87||P-value was not adjusted for multiple comparisons.|Marginal standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Analysis for Phototypes V/VI||57.87|14.35|<0.0001
72352643|NCT03726489|144224660|NON_INFERIORITY|Statistical inference was based on non-inferiority principles using a non-inferiority margin of 15%.|Risk Difference (RD)|-5.2||||0.1773|TWO_SIDED|95.0|-19.4|9.0||P-value was not adjusted for multiple comparisons.|Marginal standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Overall analysis including all skin phototypes||9.0|-19.4|0.1773
72352644|NCT03726489|144224660|NON_INFERIORITY|Statistical inference was based on non-inferiority principles using a non-inferiority margin of 15%.|Risk Difference (RD)|-6.88||||0.4073|TWO_SIDED|95.0|-26.09|12.33||P-value was not adjusted for multiple comparisons.|Marginal standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Analysis for Phototypes I/II||12.33|-26.09|0.4073
72352645|NCT03726489|144224660|NON_INFERIORITY|Statistical inference was based on non-inferiority principles using a non-inferiority margin of 15%.|Risk Difference (RD)|-12.42||||0.8247|TWO_SIDED|95.0|-35.24|10.41||P-value was not adjusted for multiple comparisons.|Marginal standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Analysis for Phototypes III/IV||10.41|-35.24|0.8247
72352646|NCT03726489|144224660|NON_INFERIORITY|Statistical inference was based on non-inferiority principles using a non-inferiority margin of 15%.|Risk Difference (RD)|37.88||||0.0133|TWO_SIDED|95.0|-4.01|79.77||P-value was not adjusted for multiple comparisons.|Marginal standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Analysis for Phototypes V/VI||79.77|-4.01|0.0133
72352647|NCT03726489|144224661|NON_INFERIORITY|Statistical inference was based on non-inferiority principles using a non-inferiority margin of 15%.|Risk Difference (RD)|6.52||||0.002|TWO_SIDED|95.0|-7.11|20.14||P-value was not adjusted for multiple comparisons.|Marginal standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Overall analysis including all skin phototypes||20.14|-7.11|0.002
72352648|NCT03726489|144224661|NON_INFERIORITY|Statistical inference was based on non-inferiority principles using a non-inferiority margin of 15%.|Risk Difference (RD)|7.77||||0.0137|TWO_SIDED|95.0|-10.35|25.89||P-value was not adjusted for multiple comparisons.|Marginal standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Analysis for Phototypes I/II||25.89|-10.35|0.0137
72352649|NCT03726489|144224661|NON_INFERIORITY|Statistical inference was based on non-inferiority principles using a non-inferiority margin of 15%.|Risk Difference (RD)|1.0||||0.1656|TWO_SIDED|95.0|-21.61|23.61||P-value was not adjusted for multiple comparisons.|Marginal standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Analysis for Phototypes III/IV||23.61|-21.61|0.1656
72352650|NCT03726489|144224661|NON_INFERIORITY|Statistical inference was based on non-inferiority principles using a non-inferiority margin of 15%.|Risk Difference (RD)|22.73||||0.1225|TWO_SIDED|95.0|-25.16|70.62||P-value was not adjusted for multiple comparisons.|Marginal standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Analysis for Phototypes V/VI||70.62|-25.16|0.1225
72352651|NCT03726489|144224662|SUPERIORITY||Risk Difference (RD)|0.105||||0.0183|TWO_SIDED|95.0|0.018|0.192|||Marginal contrast||Positive values indicate higher proportion in the home group.|Difference of proportion at week 16. Calculated using contrasts of predictive margins following logistic regression with robust variance estimators via generalized estimating equations and exchangeable correlation. Missing data for DLQI are imputed using multiple imputation via chained equations (10 imputations), and the estimates are combined using standard rules.||0.192|0.018|0.0183
72352652|NCT03726489|144224662|SUPERIORITY||Risk Difference (RD)|0.064||||0.177|TWO_SIDED|95.0|-0.029|0.158|||Marginal contrast||Positive values indicate higher proportion in the home group.|Difference of proportion at week 20. Calculated using contrasts of predictive margins following logistic regression with robust variance estimators via generalized estimating equations and exchangeable correlation. Missing data for DLQI are imputed using multiple imputation via chained equations (10 imputations), and the estimates are combined using standard rules.||0.158|-0.029|0.177
72352653|NCT03726489|144224662|SUPERIORITY||Risk Difference (RD)|-0.011||||0.815|TWO_SIDED|95.0|-0.101|0.079|||Marginal contrast||Positive values indicate higher proportion in the home group.|Difference of proportion at week 24. Calculated using contrasts of predictive margins following logistic regression with robust variance estimators via generalized estimating equations and exchangeable correlation. Missing data for DLQI are imputed using multiple imputation via chained equations (10 imputations), and the estimates are combined using standard rules.||0.079|-0.101|0.815
72352654|NCT04057807|144224667|SUPERIORITY|||||||0.14|||||||unpaired t-tests (continuous variables)|||||||0.14
72352655|NCT04057807|144224668|SUPERIORITY|||||||0.82|||||||univariate linear regression analysis|two-tailed P value was obtained from a univariate linear regression analysis||||||0.82
72352656|NCT00786799|144224672|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.3|STANDARD_DEVIATION|6.1||0.4|||||||t-test, 2 sided|||The null hypothesis is that the mean change in Aberrant Behavior Checklist Hyperactivity subscale (ABC-H) score is the same for both groups.||||0.40
72352657|NCT00287222|144224713|SUPERIORITY_OR_OTHER||percentage progression free at 27 weeks|28.0|STANDARD_ERROR_OF_MEAN|10.97||0.0006|TWO_SIDED|95.0|10.0|53.0|||one-sided exact binomial test|||Estimating the percentage of participants that remain free of disease progression at 27 weeks from the onset of treatment, and testing that proportion against a null-hypothesis proportion of 0.04 using the one-sided exact binomial test at 5% alpha, based upon historical data from the literature.||53|10|0.0006
72352658|NCT00824473|144224714|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.4286|STANDARD_ERROR_OF_MEAN|0.351|<|0.001||95.0|-2.12|-0.74|||ANCOVA|ANCOVA is being used due to a covariate being included in the model. The covariate is baseline TNSS score.||Overall change from baseline||-0.74|-2.12|<0.001
72352659|NCT00824473|144224715|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6063|STANDARD_ERROR_OF_MEAN|0.1697|<|0.001||95.0|-0.94|-0.27|||ANCOVA|ANCOVA is being used due to a covariate being included in the model. The covariate is baseline TNSS score.||||-0.27|-0.94|<0.001
72352660|NCT00824473|144224716|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.3947|STANDARD_ERROR_OF_MEAN|0.3391|<|0.001||95.0|-2.06|-0.73|||ANCOVA|ANCOVA is being used due to a covariate being included in the model. The covariate is baseline TNSS score.||Overall change from baseline||-0.73|-2.06|<0.001
72352661|NCT00824473|144224717|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9284|STANDARD_ERROR_OF_MEAN|0.2741|<|0.001||95.0|-1.47|-0.39|||ANCOVA|ANCOVA is being used due to a covariate being included in the model. The covariate is baseline TNSS score.||reflective TOSS change in baseline||-0.39|-1.47|<0.001
72352662|NCT00824473|144224718|SUPERIORITY_OR_OTHER|||||||0.01|||||||ANCOVA|ANCOVA is being used due to a covariate being included in the model. The covariate is baseline TNSS score.||change from baseline||||0.010
72352663|NCT01359904|144224720|SUPERIORITY_OR_OTHER|||||||0.027|||||||Chi-squared|||||||0.027
72352664|NCT01359904|144224721|SUPERIORITY_OR_OTHER|||||||0.67|||||||Kruskal-Wallis|||post intervention hemoglobin A1c levels||||0.67
72352665|NCT01359904|144224722|SUPERIORITY_OR_OTHER|||||||0.2|||||||Kruskal-Wallis|||||||0.20
72352666|NCT01359904|144224723|SUPERIORITY_OR_OTHER|||||||0.32|||||||Chi-squared|||||||0.32
72352667|NCT01290614|144224861|SUPERIORITY_OR_OTHER|||||||0.57|TWO_SIDED||||||t-test, 2 sided|||||||0.57
72352668|NCT01290614|144224862|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Chi-squared|||||||<0.001
72352669|NCT01825187|144224889|SUPERIORITY|||||||0.523|||||||t-test, 1 sided|||||||0.523
72352670|NCT01825187|144224890|SUPERIORITY|||||||0.371|||||||t-test, 1 sided|||Nasa Mental Demand||||0.371
72352671|NCT01825187|144224890|SUPERIORITY|||||||0.122|||||||t-test, 1 sided|||NASA Physical Demand||||0.122
72352672|NCT01825187|144224890|SUPERIORITY|||||||0.325|||||||t-test, 1 sided|||NASA Temporal Demand||||0.325
72352673|NCT01825187|144224890|SUPERIORITY|||||||0.0451|||||||t-test, 1 sided|||NASA Peformance||||0.0451
72352674|NCT02109640|144224905|SUPERIORITY_OR_OTHER||Absolute percentage difference|17.1||||0.264|TWO_SIDED|95.0|-10.0|40.7||Absolute % difference 17.1 (95% CI -10.0,40.7)|Fisher Exact|||||40.7|-10.0|0.264
72352675|NCT02109640|144224906|SUPERIORITY_OR_OTHER|||||||0.222|||||||t-test, 2 sided|||||||0.222
72352676|NCT02109640|144224907|SUPERIORITY_OR_OTHER|||||||0.676|||||||t-test, 2 sided|||||||0.676
72352677|NCT01363700|144224908|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.3|||<|0.001|TWO_SIDED|95.0|-1.52|-1.11|||t-test, 2 sided|||||-1.11|-1.52|<0.001
72352678|NCT01363700|144224909|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.3|||<|0.001|TWO_SIDED|95.0|-1.71|-0.92|||t-test, 2 sided|||||-0.92|-1.71|<0.001
72352679|NCT01363700|144224910|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority in Mean Ocular itching score compared to Olopatadine was assessed on the non-inferiority margin (0.5) with the upper limit of the confidence interval of the difference between the Epinastine (DE-114) and Olopatadine treatment groups.|Mean Difference (Final Values)|-0.1|||||TWO_SIDED|95.0|-0.21|0.08||||||||0.08|-0.21|
72352680|NCT01363700|144224911|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority in Mean Ocular hyperemia score compared to Olopatadine was assessed on the non-inferiority margin (0.5) with the upper limit of the confidence interval of the difference between the Epinastine (DE-114) and Olopatadine treatment groups.|Mean Difference (Final Values)|-0.3|||||TWO_SIDED|95.0|-0.81|0.22||||||||0.22|-0.81|
72352681|NCT02230566|144224912|SUPERIORITY||LS Mean|-64.82|||<|0.0001|TWO_SIDED|95.0|-69.66|-59.98||P-values are from GEE model including baseline value, and the post UX003 Treatment Week as a categorical variable. The covariance structure within participants was assumed to be exchangeable.|GEE|||||-59.98|-69.66|< 0.0001
72352682|NCT02230566|144224913|SUPERIORITY|||||||0.0527|||||||t-test|"P value from t-test of no change (0 change) from baseline"||||||0.0527
72352683|NCT02230566|144224914|SUPERIORITY||LS Mean|20.8||||0.2137|TWO_SIDED|95.0|-12.0|53.7||P-values are from GEE model including baseline value, and the post UX003 Treatment Week as a categorical variable. The covariance structure within participants was assumed to be exchangeable.|GEE|||||53.7|-12.0|0.2137
72352684|NCT02230566|144224917|SUPERIORITY||LS Mean|-6.5||||0.1778|TWO_SIDED|95.0|-16.1|3.0|||GEE|||Shoulder Flexion - Left||3.0|-16.1|0.1778
72352685|NCT02230566|144224917|SUPERIORITY||LS Mean|-1.5||||0.7632|TWO_SIDED|95.0|-10.9|8.0|||GEE|||Shoulder Extension - Left||8.0|-10.9|0.7632
72352686|NCT02230566|144224917|SUPERIORITY||LS Mean|-1.8||||0.6034|TWO_SIDED|95.0|-8.8|5.1|||GEE|||Shoulder Flexion - Right||5.1|-8.8|0.6034
72352687|NCT02230566|144224917|SUPERIORITY||LS Mean|-3.4||||0.3332|TWO_SIDED|95.0|-10.2|3.4|||GEE|||Shoulder Extension - Right||3.4|-10.2|0.3332
72352688|NCT02230566|144224917|SUPERIORITY||LS Mean|-9.4||||0.0415|TWO_SIDED|95.0|-18.4|-0.4|||GEE|||Tighter Shoulder Flexion||-0.4|-18.4|0.0415
72352689|NCT02230566|144224917|SUPERIORITY||LS Mean|-6.7||||0.0563|TWO_SIDED|95.0|-13.6|0.2|||GEE|||Tighter Shoulder Extension||0.2|-13.6|0.0563
72352690|NCT02230566|144224918|SUPERIORITY||LS Mean|1.0||||0.114|TWO_SIDED|95.0|-0.2|2.2|||GEE|||for the left eye||2.2|-0.2|0.1140
72352691|NCT02230566|144224918|SUPERIORITY||LS Mean|0.9||||0.0906|TWO_SIDED|95.0|-0.1|1.8|||GEE|||for the right eye||1.8|-0.1|0.0906
72352692|NCT02230566|144224919|SUPERIORITY||LS Mean|0.8||||0.0883|TWO_SIDED|95.0|-0.1|1.7|||GEE|||Scale-BALANCE||1.7|-0.1|0.0883
72352693|NCT02230566|144224919|SUPERIORITY||LS Mean|-0.2||||0.3528|TWO_SIDED|95.0|-0.7|0.2|||GEE|||Scale: FINE MOTOR PRECISION||0.2|-0.7|0.3528
72352694|NCT02230566|144224919|SUPERIORITY||LS Mean|0.2||||0.4094|TWO_SIDED|95.0|-0.2|0.6|||GEE|||Scale-MANUAL DEXTERITY||0.6|-0.2|0.4094
72352695|NCT02230566|144224919|SUPERIORITY||LS Mean|0.2||||0.102|TWO_SIDED|95.0|0.0|0.4|||GEE|||Scale-RUNNING SPEED AND AGILITY||0.4|0.0|0.1020
72352696|NCT02230566|144224920|SUPERIORITY||LS Mean|3.4||||0.1953|TWO_SIDED|95.0|-1.8|8.6|||GEE|||||8.6|-1.8|0.1953
72352697|NCT02230566|144224922|SUPERIORITY||LS Mean|-1.2||||0.2022|TWO_SIDED|95.0|-3.0|0.6|||GEE|||||0.6|-3.0|0.2022
72352698|NCT00113841|144224923|SUPERIORITY_OR_OTHER|||||||0.16||95.0|||||t-test, 2 sided|||||||0.16
72352699|NCT03507036|144224938|OTHER||||||||||||||||||A paired t-test was performed for skin lab measurement and biopsies.|||
72352700|NCT00104650|144224942|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|12.28|||<|0.001||95.0|3.35|45.03|||Cochran-Mantel-Haenszel|Adjusted for cancer type stratification factor||||45.03|3.35|<0.001
72352701|NCT00104650|144224942|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.33||||0.002||95.0|1.74|16.36|||Cochran-Mantel-Haenszel|Adjusted for cancer type stratification factor||||16.36|1.74|0.002
72352702|NCT00104650|144224942|SUPERIORITY_OR_OTHER||Percentage of participants|77.8||||||95.0|60.8|89.9||||||||89.9|60.8|
72352703|NCT00104650|144224942|SUPERIORITY_OR_OTHER||Percentage of participants|63.6||||||95.0|45.1|79.6||||||||79.6|45.1|
72352704|NCT00104650|144224942|SUPERIORITY_OR_OTHER||Percentage of participants|28.6||||||95.0|14.6|46.3||||||||46.3|14.6|
72352705|NCT00104650|144224943|SUPERIORITY_OR_OTHER||Percentage of participants|63.9||||||95.0|46.2|79.2||||||||79.2|46.2|
72352706|NCT00104650|144224943|SUPERIORITY_OR_OTHER||Percentage of participants|63.6||||||95.0|45.1|79.6||||||||79.6|45.1|
72352707|NCT00104650|144224943|SUPERIORITY_OR_OTHER||Percentage of participants|37.1||||||95.0|21.5|55.1||||||||55.1|21.5|
72352708|NCT00104650|144224944|SUPERIORITY_OR_OTHER|||||||0.388|||||||ANCOVA|Adjusted for the stratum to which participants were originally assigned by the Interactive Voice Response System (IVRS)||||||0.388
72352709|NCT00104650|144224945|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|3.79|||<|0.001||95.0|2.01|7.15|||Regression, Cox|Stratified by cancer type and screening uNTx level||||7.15|2.01|<0.001
72352710|NCT00104650|144224945|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|4.32|||<|0.001||95.0|2.23|8.36|||Regression, Cox|Stratified by cancer type and screening uNTx level||||8.36|2.23|<0.001
72352711|NCT00104650|144224946|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.274||||0.006||95.0|0.11|0.687|||Regression, Cox|Adjusted for cancer type stratification factor and screening uNTx level||||0.687|0.110|0.006
72352712|NCT00104650|144224946|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.199||||0.001||95.0|0.076|0.523|||Regression, Cox|Adjusted for cancer type stratification factor and screening uNTx level||||0.523|0.076|0.001
72352713|NCT00104650|144224947|SUPERIORITY_OR_OTHER|||||||0.056|||||||ANCOVA|Adjusted for the stratum to which participants were originally assigned by the Interactive Voice Response System (IVRS)||||||0.056
72352714|NCT00104650|144224948|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.162||||0.105||95.0|0.018|1.465|||Regression, Cox|||||1.465|0.018|0.105
72352715|NCT00104650|144224948|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.573||||0.43||95.0|0.143|2.289|||Regression, Cox|||||2.289|0.143|0.430
72352716|NCT00104650|144224949|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.26||||||95.0|0.05|1.44||||||||1.44|0.05|
72352717|NCT00104650|144224949|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.36||||||95.0|0.08|1.76||||||||1.76|0.08|
72352718|NCT02294058|144224951|SUPERIORITY||Rate Ratio|0.518|||<|0.0001|TWO_SIDED|95.0|0.405|0.663||To account for multiple comparisons, each of the 2 treatment comparisons was tested at the alpha = 0.025 level.|Poisson regression model|Adjusted for region, Baseline age, number of gadolinium enhancing (GdE) lesions and included the natural log transformation of time as an offset term.||||0.663|0.405|<0.0001
72352719|NCT02294058|144224951|SUPERIORITY||Rate Ratio|0.688||||0.0013|TWO_SIDED|95.0|0.547|0.864||To account for multiple comparisons, each of the 2 treatment comparisons was tested at the alpha = 0.025 level.|Poisson Regression Model|Adjusted for region, Baseline age and the number of GdE lesions, and included the natural log transformation of time on study as an offset term.||||0.864|0.547|0.0013
72352720|NCT02294058|144224952|SUPERIORITY||Rate Ratio|0.517|||<|0.0001|TWO_SIDED|95.0|0.427|0.625||To account for multiple comparisons, each of the 2 treatment comparisons was tested at the alpha = 0.05 level.|Negative Binomial Regression Model|Adjusted for region, Baseline age and GdE lesions; included the natural log transformation of available MRI scans over 12 months as an offset term.|Rate Ratio = Ozanimod / IFN β-1a|||0.625|0.427|<0.0001
72352721|NCT02294058|144224952|SUPERIORITY||Rate Ratio|0.754||||0.0032|TWO_SIDED|95.0|0.625|0.91||To account for multiple comparisons, each of the 2 treatment comparisons was tested at the alpha = 0.05 level.|Negative binomial regression model|Adjusted for region, Baseline age and GdE lesions; included the natural log transformation of available MRI scans over 12 months as an offset term.|Rate Ratio = Ozanimod / IFN β-1a|||0.910|0.625|0.0032
72352722|NCT02294058|144224953|SUPERIORITY||Rate Ratio|0.37|||<|0.0001|TWO_SIDED|95.0|0.256|0.536||To account for multiple comparisons, each of the 2 treatment comparisons was tested at the alpha = 0.05 level.|Negative Binomial Regression Model|Adjusted for region, Baseline age and GdE lesions; included the natural log transformation of available MRI scans as an offset term.||||0.536|0.256|<0.0001
72352723|NCT02294058|144224953|SUPERIORITY||Rate Ratio|0.662||||0.0182|TWO_SIDED|95.0|0.471|0.932||To account for multiple comparisons, each of the 2 treatment comparisons was tested at the alpha = 0.05 level.|Negative binomial regression model|Adjusted for region, Baseline age and GdE lesions; included the natural log transformation of available MRI scans as an offset term.||||0.932|0.471|0.0182
72352724|NCT02294058|144224954|SUPERIORITY||Hazard Ratio (HR)|0.69||||0.3055|TWO_SIDED|95.0|0.34|1.402|||Cox proportional hazards model|Based on the Cox proportional hazard model with factors for treatment group, adjusted for region, Baseline age, and Baseline EDSS score|Hazard Ratio (Ozanimod / IFN β-1a)|||1.402|0.340|0.3055
72352725|NCT02294058|144224954|SUPERIORITY||Hazard Ratio (HR)|0.886||||0.7163|TWO_SIDED|95.0|0.46|1.705|||Cox proportional hazards model|Based on the Cox proportional hazard model with factors for treatment group, adjusted for region, Baseline age and Baseline EDSS score|Hazard Ratio (Ozanimod / IFN β-1a)|||1.705|0.460|0.7163
72352726|NCT02294058|144224955|SUPERIORITY||Hazard Ratio (HR)|1.238||||0.6725|TWO_SIDED|95.0|0.46|3.337|||Cox proportional hazards model|Based on the Cox proportional hazard model with factors for treatment group, adjusted for region, Baseline age and Baseline EDSS score|Hazard Ratio (Ozanimod / IFN β-1a)|||3.337|0.460|0.6725
72369511|NCT00740857|144249260|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Proportional hazards model|Adjusted with treatment, baseline Pain Severity Rating (PSR), and gender terms.||||||<0.001
72352727|NCT02294058|144224955|SUPERIORITY||Hazard Ratio (HR)|1.535||||0.3755|TWO_SIDED|95.0|0.595|3.963|||Cox proportional hazard model|Based on the Cox proportional hazard model with factors for treatment group, adjusted for region, Baseline age and Baseline EDSS score|Hazard Ratio (Ozanimod / IFN β-1a)|||3.963|0.595|0.3755
72352728|NCT02294058|144224956|SUPERIORITY||Difference in Percentages|10.88||||0.0006|TWO_SIDED|95.0|4.84|16.92|||Cochran-Mantel-Haenszel|Based on the CMH test stratified by region and EDSS category per Interactive Voice Response System (IVRS)||||16.92|4.84|0.0006
72352729|NCT02294058|144224956|SUPERIORITY||Difference in Percentages|5.12||||0.113|TWO_SIDED|95.0|-1.07|11.32|||Cochran-Mantel-Haenszel|Based on the CMH test stratified by region and EDSS category per IVRS.||||11.32|-1.07|0.1130
72352730|NCT02294058|144224957|SUPERIORITY||Difference in Percentages|4.53||||0.118|TWO_SIDED|95.0|-1.19|10.24|||Cochran-Mantel-Haenszel|Based on the CMH test stratified by region and EDSS Scale category per IVRS.||||10.24|-1.19|0.1180
72352731|NCT02294058|144224957|SUPERIORITY||Difference in percentages|2.95||||0.3023|TWO_SIDED|95.0|-2.7|8.6|||Cochran-Mantel-Haenszel|Based on the CMH test stratified by region and EDSS Scale category per IVRS.||||8.60|-2.70|0.3023
72352732|NCT02294058|144224958|SUPERIORITY||||||<|0.0001|||||||Rank ANCOVA|Adjusted for region and EDSS category per IVRS||Due to the non-normal distribution of the data for brain volume loss, the analyses for percent change from baseline in normalized brain volume were compared using rank-ANCOVA, adjusted for region (Eastern Europe vs Rest of World), and EDSS category per IVRS, with the dependent variable as the residual of the rank of brain volume at Baseline regressed on rank of percent change.||||<0.0001
72352733|NCT02294058|144224958|SUPERIORITY|||||||0.0615|||||||Rank ANCOVA|Adjusted for region and EDSS Scale per IVRS||Due to the non-normal distribution of the data for brain volume loss, the analyses for percent change from baseline in normalized brain volume were compared using rank-ANCOVA, adjusted for region (Eastern Europe vs Rest of World), and EDSS category per IVRS, with the dependent variable as the residual of the rank of brain volume at Baseline regressed on rank of percent change.||||0.0615
72352734|NCT02294058|144224959|SUPERIORITY||LS Mean Difference|0.034||||0.129|TWO_SIDED|95.0|-0.01|0.077|||ANCOVA|Adjusted for region, EDSS category per IVRS and the Baseline MSFC score.||||0.077|-0.010|0.1290
72352735|NCT02294058|144224959|SUPERIORITY||LS Mean Difference|0.015||||0.4942|TWO_SIDED|95.0|-0.028|0.059|||ANCOVA|Adjusted for region, EDSS category per IVRS and the Baseline MSFC score||||0.059|-0.028|0.4942
72352736|NCT02294058|144224960|SUPERIORITY||Mean Difference (Final Values)|1.642||||0.0364|TWO_SIDED|95.0|0.104|3.18|||ANCOVA|Adjusted for region, EDSS category per IVRS, and the Baseline summary score.||Analysis of Physical Health Composite Summary||3.180|0.104|0.0364
72352737|NCT02294058|144224960|SUPERIORITY||Mean Difference (Final Values)|1.024||||0.1905|TWO_SIDED|95.0|-0.51|2.559|||ANCOVA|Adjusted for region, EDSS category per IVRS, and the Baseline summary score.||Analysis of Physical Health Composite Summary||2.559|-0.510|0.1905
72352738|NCT02294058|144224960|SUPERIORITY||Mean Difference (Final Values)|0.356||||0.7104|TWO_SIDED|95.0|-1.523|2.234|||ANCOVA|Adjusted for region, EDSS category per IVRS, and the Baseline summary score.||Analysis of Mental Health Composite Summary||2.234|-1.523|0.7104
72352739|NCT02294058|144224960|SUPERIORITY||Mean Difference (Final Values)|-0.17||||0.8587|TWO_SIDED|95.0|-2.045|1.705|||ANCOVA|Adjusted for region, EDSS category per IVRS, and the Baseline summary score.||Analysis of Mental Health Composite Summary||1.705|-2.045|0.8587
72352740|NCT04184297|144225011|OTHER||Hazard Ratio (HR)|0.85|||||TWO_SIDED|95.0|0.76|0.96|||Regression, Cox|The method was used to calculate hazard ratios with 95% confidence intervals.|Hazard ratio of Tiotropium+Olodaterol versus LABA/LAMA/ICS.|Cox proportional hazard regression models were used to assess the effect of Tiotropium + Olodaterol combination versus the Long-acting beta agonist / inhaled corticosteroid (LABA/LAMA/ICS) therapy combination on the risk of first COPD exacerbation for overall population.||0.96|0.76|
72352741|NCT04184297|144225012|OTHER||Hazard Ratio (HR)|0.83|||||TWO_SIDED|95.0|0.64|1.07|||Regression, Cox|This method was used to calculate hazard ratios with 95% confidence intervals.|Hazard ratio of Tiotropium+Olodaterol versus LABA/LAMA/ICS.|Cox proportional hazard regression models were used to assess the effect of Tiotropium + Olodaterol combination versus the Long-acting beta agonist / inhaled corticosteroid (LABA/LAMA/ICS) therapy combination on the risk of a hospitalization for community-acquired pneumonia for overall population.||1.07|0.64|
72352742|NCT04184297|144225013|OTHER||Hazard Ratio (HR)|1.04|||||TWO_SIDED|95.0|0.91|1.19|||Regression, Cox|The method was used to calculate hazard ratios with 95% confidence intervals.|Hazard ratio of Tiotropium+Olodaterol versus LABA/LAMA/ICS.|Cox proportional hazard regression models were used to assess the effect of Tiotropium + Olodaterol combination versus the Long-acting beta agonist / inhaled corticosteroid (LABA/LAMA/ICS) therapy combination on the risk of first COPD exacerbation for overall population.||1.19|0.91|
72352743|NCT02412098|144225014|OTHER||Geometric Least Square Mean (GLSM) Ratio|73.54|||||TWO_SIDED|90.0|41.92|129.01|||||A 90% CI was constructed for the GLSM ratio of AUCinf in the hepatic impairment group versus matched control.|An analysis of variance (ANOVA) appropriate for a parallel design was fit to the natural logarithmic transformation of eleclazine AUCinf.||129.01|41.92|
72352744|NCT02412098|144225014|OTHER||GLSM Ratio (%)|127.8|||||TWO_SIDED|90.0|73.57|222.01|||||A 90% CI was constructed for the GLSM ratio of AUCinf in the hepatic impairment group versus matched control.|An analysis of variance (ANOVA) appropriate for a parallel design was fit to the natural logarithmic transformation of eleclazine AUCinf.||222.01|73.57|
72352745|NCT02412098|144225015|OTHER||GLSM Ratio (%)|80.82|||||TWO_SIDED|90.0|45.11|144.79|||||A 90% CI was constructed for the GLSM ratio of AUCinf in the hepatic impairment group versus matched control.|ANOVA appropriate for a parallel design was fit to the natural logarithmic transformation of GS-623134 AUCinf.||144.79|45.11|
72352746|NCT02412098|144225015|OTHER||GLSM Ratio (%)|73.52|||||TWO_SIDED|90.0|47.83|113.02||ANOVA appropriate for a parallel design was fit to the natural logarithmic transformation of GS-623134 AUCinf.|||A 90% CI was constructed for the GLSM ratio of AUCinf in the hepatic impairment group versus matched control.|||113.02|47.83|
72352747|NCT02412098|144225016|OTHER||GLSM Ratio (%)|66.55|||||TWO_SIDED|90.0|53.33|83.04|||||A 90% CI was constructed for the GLSM ratio of Cmax in the hepatic impairment group versus matched control.|ANOVA appropriate for a parallel design was fit to the natural logarithmic transformation of eleclazine Cmax.||83.04|53.33|
72352748|NCT02412098|144225016|OTHER||GLSM Ratio (%)|102.06|||||TWO_SIDED|90.0|83.03|125.45|||||A 90% CI was constructed for the GLSM ratio of Cmax in the hepatic impairment group versus matched control.|ANOVA appropriate for a parallel design was fit to the natural logarithmic transformation of eleclazine Cmax.||125.45|83.03|
72352749|NCT02412098|144225017|OTHER||GLSM Ratio (%)|76.24|||||TWO_SIDED|90.0|50.65|114.77|||||A 90% CI was constructed for the GLSM ratio of Cmax in the hepatic impairment group versus matched control.|ANOVA appropriate for a parallel design was fit to the natural logarithmic transformation of GS-623134 Cmax.||114.77|50.65|
72352750|NCT02412098|144225017|OTHER||GLSM Ratio (%)|71.06|||||TWO_SIDED|90.0|44.59|113.25|||||A 90% CI was constructed for the GLSM ratio of Cmax in the hepatic impairment group versus matched control.|ANOVA appropriate for a parallel design was fit to the natural logarithmic transformation of GS-623134 Cmax.||113.25|44.59|
72352751|NCT03089580|144225020|SUPERIORITY|Paired, Student's t-test was used to contrast the outcome variable of TBUT in the treated eye versus the sham eye from visit 1 to visit 5. The null hypothesis to be tested is one of no change from pre- to post treatment, with a Type I error probability of 0.05 for the primary outcome assessment. The pattern of change over the 4 treatment visits in these continuous variables will be assessed using mixed, linear regression. SAS version 9.4 statistical software (SAS Institute, Cary, NC) was used.||||||0.3|||||||paired t test|||The primary study outcome of pre to post change in TBUT within the treated eye and also the untreated, control eye dictated the use of a paired statistical approach to sample size estimation. Clinically relevant pre to post TBUT increase of 3 seconds with a standard deviation of 4.5 seconds was used. Type I and II error estimates used were standard for a non-pivotal study, 0.05 \& 0.20. The estimated the sample size needed detect this difference in TBUT is 27 subjects.||||0.3
72352752|NCT03089580|144225021|SUPERIORITY|The p-value results from a test of the hypothesis that the change in OSDI from visit 1 does not differ from zero. Change distributions that met normal distribution test criteria (Shapiro-Wilk p-value \>0.05) were tested with the paired Student's t-test; non-normal change distributions (at visits 2 \& 4) were tested with the non-parametric Wilcoxon signed rank test.||||||0.2026|||||||paired t test|||||||0.2026
72352753|NCT03087513|144225022|SUPERIORITY||||||<|0.01||||||In all cases of motor evoked potential changes, a P-value of 0.05 was considered significant.|Mixed Models Analysis|As the amplitude values were non-normally distributed, the Mann-Whitney U test was performed to compare the two groups.||In total, 40 patients were randomised for the study. Data from 2 patients were excluded as the crossover arm could not be completed due to intraoperative MEP change (n=1) and the equipment malfunction (n=1). The data distributions were tested for normality with the Kolmogorov-Smirnov test.||||<0.01
72352754|NCT01712204|144225048|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.81|STANDARD_ERROR_OF_MEAN|0.113||0.1356|TWO_SIDED|95.0|0.62|1.07|||Possion regression|||||1.07|0.62|0.1356
72352755|NCT02781610|144225087|NON_INFERIORITY|The non-inferiority margin is -3.5%.|Mean Difference (Final Values)|-0.7||||0.0164|TWO_SIDED|95.0|-3.3|2.0|||ANOVA|Adjusted for four dichotomous randomization strata.||The ERR non-inferiority test was a priori designed to be conducted on the per-protocol (PP) population for 93% power assuming 2-sided alpha=0.05 with 155 PP participants per arm. Difference between ERR treatment duration arms is ERR-10 - ERR-14.||2.0|-3.3|0.0164
72352756|NCT02781610|144225088|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.568|TWO_SIDED|95.0|-1.3|1.1|||ANOVA|Adjusted for four dichotomous randomization strata.||The NERR superiority test was a priori designed to be conducted on the Intent-to-Treat (ITT) population for 91% power to detect a 2.5% difference, assuming 2-sided alpha=0.05 with 285 ITT participants per arm. Difference between NERR treatment duration arms is NERR-21 - NERR-14.||1.1|-1.3|0.568
72352757|NCT02781610|144225089|SUPERIORITY||Mean Difference (Final Values)|1.1||||0.546|TWO_SIDED|95.0|-2.4|4.6|||t-test, 2 sided|||Difference between ERR treatment duration arms is ERR-10 - ERR-14.||4.6|-2.4|0.546
72352758|NCT02781610|144225090|SUPERIORITY||Mean Difference (Final Values)|-1.6||||0.14|TWO_SIDED|95.0|-3.7|0.5|||t-test, 2 sided|||Difference between NERR treatment duration arms is NERR-21 - NERR-14.||0.5|-3.7|0.140
72352759|NCT02781610|144225091|SUPERIORITY||Mean Difference (Final Values)|0.17||||0.563|TWO_SIDED|95.0|-0.42|0.77|||t-test, 2 sided|||Difference between ERR treatment duration arms is ERR-10 - ERR-14.||0.77|-0.42|0.563
72352760|NCT02781610|144225092|SUPERIORITY|Difference between NERR treatment duration arms is NERR-21 - NERR-14.|Mean Difference (Final Values)|0.29||||0.083|TWO_SIDED|95.0|-0.04|0.61|||t-test, 2 sided|||||0.61|-0.04|0.083
72352761|NCT02679287|144225093|SUPERIORITY||Mean Difference (Final Values)|1.8|||<|0.0001|TWO_SIDED|95.0|1.2|2.4|||Mixed Models Analysis|||The null hypothesis is that there is no difference in percentage of time \<70 mg/dL in SAP vs. evening-overnight CLC session. Change in HbA1c during study sessions was used as a covariate of the model.||2.4|1.2|<0.0001
72352762|NCT05298202|144225158|SUPERIORITY|time x treatment ANOVA||||||0.284||||||difference between treatment and control|ANOVA|||||||0.284
72352763|NCT05298202|144225159|SUPERIORITY|||||||0.177|||||||t-test, 2 sided|||||||.177
72352764|NCT05298202|144225160|SUPERIORITY|||||||0.122|||||||t-test, 2 sided|||||||.122
72352765|NCT05298202|144225161|SUPERIORITY|||||||0.038|||||||ANOVA|time x treatment anova||||||.038
72352766|NCT05298202|144225162|SUPERIORITY|||||||0.976|||||||ANOVA|||||||.976
72352767|NCT05298202|144225163|SUPERIORITY|||||||0.747|||||||ANOVA|||||||.747
72352768|NCT01875159|144225164|SUPERIORITY_OR_OTHER||||||<|0.05|||||||GEE gamma regression models|||\>80% probability of detecting at least a 36% reduction in intermittent hypoxia events/hour of recording and in sec/hour \<90% oxygen saturation/hour of recording||||<0.05
72352769|NCT01389882|144225183|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.007|STANDARD_DEVIATION|2.015||0.043|TWO_SIDED|95.0|0.036|1.978|||Paired t-test|||||1.978|0.036|0.043
72352770|NCT01389882|144225184|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.232|STANDARD_DEVIATION|0.841||0.245|TWO_SIDED|95.0|-0.637|0.174|||Paired t-test|||||0.174|-0.637|0.245
72352771|NCT01389882|144225185|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.026|STANDARD_DEVIATION|0.095||0.257|TWO_SIDED|95.0|-0.02|0.714|||Paired t-test|||||0.714|-0.020|0.257
72352772|NCT01389882|144225186|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.188|STANDARD_DEVIATION|1.541||0.601|TWO_SIDED|95.0|-0.554|0.931|||Paired t-test|||||0.931|-0.554|0.601
72352773|NCT01389882|144225187|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.149|STANDARD_DEVIATION|0.355||0.085|TWO_SIDED|95.0|-0.32|0.023|||Paired t-test|||||0.023|-0.320|0.085
72352774|NCT01389882|144225188|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.516|STANDARD_DEVIATION|9.786||0.002|TWO_SIDED|95.0|1.799|11.232|||Wilcoxon signed-rank test|||||11.232|1.799|0.002
72352775|NCT01389882|144225189|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.69|STANDARD_DEVIATION|2.516||0.009|TWO_SIDED|95.0|0.478|2.904|||Paired t-test, 2-sided|||||2.904|0.478|0.009
72352776|NCT01389882|144225190|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.692|STANDARD_DEVIATION|2.192||0.314|TWO_SIDED|95.0|-0.364|1.749|||Wilcoxon signed-rank test|||||1.749|-0.364|0.314
72352777|NCT01389882|144225191|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.007|STANDARD_DEVIATION|0.047||0.515|TWO_SIDED|95.0|-0.03|0.016|||Paired t-test|||||0.016|-0.030|0.515
72352778|NCT01389882|144225192|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1105|STANDARD_DEVIATION|7.501||0.949|TWO_SIDED|95.0|-3.505|3.726|||Paired t-test|||||3.726|-3.505|0.949
72352779|NCT01389882|144225193|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.053|STANDARD_DEVIATION|12.081||0.709|TWO_SIDED|95.0|-4.77|6.875|||Paired t-test|||||6.875|-4.770|0.709
72352780|NCT01389882|144225194|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.274|STANDARD_DEVIATION|2.233||0.6|TWO_SIDED|95.0|-1.35|0.802|||Paired t-test|||||0.802|-1.350|0.600
72352781|NCT01116401|144225216|SUPERIORITY_OR_OTHER|||||||0.007|||||||Regression, Linear|||||||0.007
72352782|NCT01116401|144225217|SUPERIORITY_OR_OTHER||||||<|0.01|||||||Regression, Linear|||||||<0.01
72352783|NCT02660853|144225250|SUPERIORITY|||||||0.745|||||||t-test, 2 sided|||Baseline versus during exacerbation.||||0.745
72352784|NCT02660853|144225254|SUPERIORITY|||||||0.326|||||||t-test, 2 sided|||||||0.326
72352785|NCT00796666|144225279|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.8616||||0.5416|TWO_SIDED|95.0|0.602|1.233|||Log Rank|||||1.233|0.602|0.5416
72352786|NCT00796666|144225280|SUPERIORITY_OR_OTHER|||||||0.0049|TWO_SIDED|||||P-value was based on the analysis of covariance on change from baseline with B1321003 treatment, B1321001 (NCT00795639) treatment, B1321003 Baseline WHO Functional Class (FC) as fixed effects and baseline 6 Minute Walk Distance (6MWD) as a covariate.|ANCOVA|||Baseline to Week 12||||0.0049
72352787|NCT00796666|144225281|SUPERIORITY_OR_OTHER|||||||0.8223|TWO_SIDED|||||Missing values at Week 12 and Week 24 were imputed with the last non-missing WHO FC based on the last observation carried forward (LOCF) method.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test used modified ridit scores and the p-value corresponding to the ANCOVA (row mean scores) statistic was reported.||Baseline to Week 12||||0.8223
72352788|NCT00796666|144225282|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.97|STANDARD_ERROR_OF_MEAN|1.09|||TWO_SIDED|95.0|-3.13|1.2|||||Least squared (LS) mean and p-value based on analysis of covariance on change from baseline with B1321003 treatment, B1321001 (NCT00795639) treatment, B1321003 Baseline WHO FC as fixed effects and baseline Physical Functioning Score as a covariate.|Baseline to Week 12||1.20|-3.13|
72352789|NCT00796666|144225282|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.33|STANDARD_ERROR_OF_MEAN|1.02|||TWO_SIDED|95.0|0.31|4.36|||||Least squared (LS) mean and p-value based on analysis of covariance on change from baseline with B1321003 treatment, B1321001 (NCT00795639) treatment, B1321003 Baseline WHO FC as fixed effects and baseline Physical Functioning Score as a covariate.|Baseline to Week 12||4.36|0.31|
72352790|NCT00796666|144225282|SUPERIORITY_OR_OTHER|||||||0.0094|TWO_SIDED|||||P-value based on analysis of covariance on change from baseline with B1321003 treatment, B1321001 (NCT00795639) treatment, B1321003 Baseline WHO FC as fixed effects and baseline Physical Functioning Score as a covariate.|ANCOVA|||Baseline to Week 12||||0.0094
72352791|NCT00796666|144225283|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.36|STANDARD_ERROR_OF_MEAN|1.29|||TWO_SIDED|95.0|-3.92|1.2|||||LS mean based on analysis of covariance on change from baseline with B1321003 treatment, B1321001 (NCT00795639) treatment, B1321003 Baseline WHO FC as fixed effects and baseline Role Limitations Due to Physical Health Problems Score as a covariate.|Baseline to Week 12||1.20|-3.92|
72352792|NCT00796666|144225283|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.99|STANDARD_ERROR_OF_MEAN|1.19|||TWO_SIDED|95.0|-0.38|4.35|||||LS mean based on analysis of covariance on change from baseline with B1321003 treatment, B1321001 (NCT00795639) treatment, B1321003 Baseline WHO FC as fixed effects and baseline Role Limitations Due to Physical Health Problems Score as a covariate.|Baseline to Week 12||4.35|-0.38|
72352793|NCT00796666|144225283|SUPERIORITY_OR_OTHER|||||||0.0244|TWO_SIDED|||||P-value based on analysis of covariance on change from baseline with B1321003 treatment, B1321001 (NCT00795639) treatment, B1321003 Baseline WHO FC as fixed effects and baseline Role Limitations Due to Physical Health Problems Score as a covariate.|ANCOVA|||Baseline to Week 12||||0.0244
72352794|NCT00796666|144225284|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.87|STANDARD_ERROR_OF_MEAN|1.46|||TWO_SIDED|95.0|-3.78|2.04|||||LS mean based on analysis of covariance on change from baseline with B1321003 treatment, B1321001 (NCT00795639) treatment, B1321003 Baseline WHO FC as fixed effects and baseline Bodily Pain Score as a covariate.|Baseline to Week 12||2.04|-3.78|
72352795|NCT00796666|144225284|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.24|STANDARD_ERROR_OF_MEAN|1.34|||TWO_SIDED|95.0|-0.41|4.9|||||LS mean based on analysis of covariance on change from baseline with B1321003 treatment, B1321001 (NCT00795639) treatment, B1321003 Baseline WHO FC as fixed effects and baseline Bodily Pain Score as a covariate.|Baseline to Week 12||4.90|-0.41|
72352796|NCT00796666|144225284|SUPERIORITY_OR_OTHER|||||||0.0624|TWO_SIDED|||||P-value based on analysis of covariance on change from baseline with B1321003 treatment, B1321001 (NCT00795639) treatment, B1321003 Baseline WHO FC as fixed effects and baseline Bodily Pain Score as a covariate.|ANCOVA|||Baseline to Week 12||||0.0624
72352797|NCT00796666|144225285|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.25|STANDARD_ERROR_OF_MEAN|1.17|||TWO_SIDED|95.0|-2.57|2.06|||||LS mean based on analysis of covariance on change from baseline with B1321003 treatment, B1321001 (NCT00795639) treatment, B1321003 Baseline WHO FCvas fixed effects and baseline General Health Score as a covariate.|Baseline to Week 12||2.06|-2.57|
72352798|NCT00796666|144225285|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.65|STANDARD_ERROR_OF_MEAN|1.09|||TWO_SIDED|95.0|0.48|4.82|||||LS mean based on analysis of covariance on change from baseline with B1321003 treatment, B1321001 (NCT00795639) treatment, B1321003 Baseline WHO FC as fixed effects and baseline General Health Score as a covariate.|Baseline to Week 12||4.82|0.48|
72352799|NCT00796666|144225285|SUPERIORITY_OR_OTHER|||||||0.0324|TWO_SIDED|||||P-value based on analysis of covariance on change from baseline with B1321003 treatment, B1321001 (NCT00795639) treatment, B1321003 Baseline WHO FC as fixed effects and baseline General Health Score as a covariate.|ANCOVA|||Baseline to Week 12||||0.0324
72352800|NCT00796666|144225286|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.44|STANDARD_ERROR_OF_MEAN|1.28|||TWO_SIDED|95.0|-2.1|2.97|||||LS mean based on analysis of covariance on change from baseline with B1321003 treatment, B1321001 (NCT00795639) treatment, B1321003 Baseline WHO FC as fixed effects and baseline Vitality Score as a covariate.|Baseline to Week 12||2.97|-2.10|
72352801|NCT00796666|144225286|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.09|STANDARD_ERROR_OF_MEAN|1.19|||TWO_SIDED|95.0|1.74|6.45|||||LS mean based on analysis of covariance on change from baseline with B1321003 treatment, B1321001 (NCT00795639) treatment, B1321003 Baseline WHO FC as fixed effects and baseline Vitality Score as a covariate.|Baseline to Week 12||6.45|1.74|
72352802|NCT00796666|144225286|SUPERIORITY_OR_OTHER|||||||0.0136|TWO_SIDED|||||P-value based on analysis of covariance on change from baseline with B1321003 treatment, B1321001 (NCT00795639) treatment, B1321003 Baseline WHO FC as fixed effects and baseline Vitality Score as a covariate.|ANCOVA|||Baseline to Week 12||||0.0136
72352803|NCT00796666|144225287|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.45|STANDARD_ERROR_OF_MEAN|1.4|||TWO_SIDED|95.0|-2.33|3.23|||||LS mean based on analysis of covariance on change from baseline with B1321003 treatment, B1321001 (NCT00795639) treatment, B1321003 Baseline WHO FC as fixed effects and baseline Social Functioning Score as a covariate.|Baseline to Week 12||3.23|-2.33|
72352804|NCT00796666|144225287|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.73|STANDARD_ERROR_OF_MEAN|1.31|||TWO_SIDED|95.0|0.14|5.32|||||LS mean based on analysis of covariance on change from baseline with B1321003 treatment, B1321001 (NCT00795639) treatment, B1321003 Baseline WHO FC as fixed effects and baseline Social Functioning Score as a covariate.|Baseline to Week 12||5.32|0.14|
72352805|NCT00796666|144225287|SUPERIORITY_OR_OTHER|||||||0.1582|TWO_SIDED|||||P-value based on analysis of covariance on change from baseline with B1321003 treatment, B1321001 (NCT00795639) treatment, B1321003 Baseline WHO FC as fixed effects and baseline Social Functioning Score as a covariate.|ANCOVA|||Baseline to Week 12||||0.1582
72352806|NCT00796666|144225288|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|1.58|||TWO_SIDED|95.0|-3.09|3.18|||||LS mean based on analysis of covariance on change from baseline with B1321003 treatment, B1321001 (NCT00795639) treatment, B1321003 Baseline WHO FC as fixed effects and baseline Role Limitation Due to Emotional Problems Score as a covariate.|Baseline to Week 12||3.18|-3.09|
72352807|NCT00796666|144225288|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.27|STANDARD_ERROR_OF_MEAN|1.46|||TWO_SIDED|95.0|-0.62|5.16|||||LS mean based on analysis of covariance on change from baseline with B1321003 treatment, B1321001 (NCT00795639) treatment, B1321003 Baseline WHO FC as fixed effects and baseline Role Limitation Due to Emotional Problems Score as a covariate.|Baseline to Week 12||5.16|-0.62|
72352808|NCT00796666|144225288|SUPERIORITY_OR_OTHER|||||||0.2161|TWO_SIDED|||||P-value based on analysis of covariance on change from baseline with B1321003 treatment, B1321001 (NCT00795639) treatment, B1321003 Baseline WHO FC as fixed effects and baseline Role Limitation Due to Emotional Problems Score as a covariate.|ANCOVA|||Baseline to Week 12||||0.2161
72352809|NCT00796666|144225289|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.44|STANDARD_ERROR_OF_MEAN|1.54|||TWO_SIDED|95.0|-1.61|4.5|||||LS mean based on analysis of covariance on change from baseline with B1321003 treatment, B1321001 (NCT00795639) treatment, B1321003 Baseline WHO FC as fixed effects and baseline Mental Health Score as a covariate.|Baseline to Week 12||4.50|-1.61|
72352810|NCT00796666|144225289|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.66|STANDARD_ERROR_OF_MEAN|1.43|||TWO_SIDED|95.0|0.82|6.5|||||LS mean based on analysis of covariance on change from baseline with B1321003 treatment, B1321001 (NCT00795639) treatment, B1321003 Baseline WHO FC as fixed effects and baseline Mental Health Score as a covariate.|Baseline to Week 12||6.50|0.82|
72352811|NCT00796666|144225289|SUPERIORITY_OR_OTHER|||||||0.2087|TWO_SIDED|||||P-value based on analysis of covariance on change from baseline with B1321003 treatment, B1321001 (NCT00795639) treatment, B1321003 Baseline WHO FC as fixed effects and baseline Mental Health Score as a covariate.|ANCOVA|||Baseline to Week 12||||0.2087
72352812|NCT00796666|144225290|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.18|STANDARD_ERROR_OF_MEAN|1.21|||TWO_SIDED|95.0|-1.21|3.58|||||LS mean based on analysis of covariance on change from baseline with B1321003 treatment, B1321001 (NCT00795639) treatment, B1321003 Baseline WHO FC as fixed effects and baseline Composite Mental Health Score as a covariate.|Baseline to Week 12||3.58|-1.21|
72352813|NCT00796666|144225290|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.71|STANDARD_ERROR_OF_MEAN|1.18|||TWO_SIDED|95.0|0.37|5.05|||||LS mean based on analysis of covariance on change from baseline with B1321003 treatment, B1321001 (NCT00795639) treatment, B1321003 Baseline WHO FC as fixed effects and baseline Composite Mental Health Score as a covariate.|Baseline to Week 12||5.05|0.37|
72352814|NCT00796666|144225290|SUPERIORITY_OR_OTHER|||||||0.2897|TWO_SIDED|||||P-value based on analysis of covariance on change from baseline with B1321003 treatment, B1321001 (NCT00795639) treatment, B1321003 Baseline WHO FC as fixed effects and baseline Composite Mental Health Score as a covariate.|ANCOVA|||Baseline to Week 12||||0.2897
72352815|NCT00796666|144225291|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.33|STANDARD_ERROR_OF_MEAN|0.86|||TWO_SIDED|95.0|-2.05|1.38|||||LS mean based on analysis of covariance on change from baseline with B1321003 treatment, B1321001 (NCT00795639) treatment, B1321003 Baseline WHO FC as fixed effects and baseline Composite Physical Health Score as a covariate.|Baseline to Week 12||1.38|-2.05|
72352816|NCT00796666|144225291|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.14|STANDARD_ERROR_OF_MEAN|0.85|||TWO_SIDED|95.0|0.46|3.82|||||LS mean based on analysis of covariance on change from baseline with B1321003 treatment, B1321001 (NCT00795639) treatment, B1321003 Baseline WHO FC as fixed effects and baseline Composite Physical Health Score as a covariate.|Baseline to Week 12||3.82|0.46|
72352817|NCT00796666|144225291|SUPERIORITY_OR_OTHER|||||||0.0179|TWO_SIDED|||||P-value based on analysis of covariance on change from baseline with B1321003 treatment, B1321001 (NCT00795639) treatment, B1321003 Baseline WHO FC as fixed effects and baseline Composite Physical Health Score as a covariate.|ANCOVA|||Baseline to Week 12||||0.0179
72369512|NCT00740857|144249260|SUPERIORITY_OR_OTHER|||||||0.001|||||||Proportional hazards model|Adjusted with treatment, baseline Pain Severity Rating (PSR), and gender terms.||||||0.001
72369513|NCT00740857|144249260|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Proportional hazards model|Adjusted with treatment, baseline Pain Severity Rating (PSR), and gender terms.||||||<0.001
72369514|NCT00740857|144249261|SUPERIORITY_OR_OTHER|||||||0.118|||||||ANOVA|With treatment, baseline Pain Severity Rating (PSR), and gender terms.||15 minutes||||0.118
72369515|NCT00740857|144249261|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA|With treatment, baseline Pain Severity Rating (PSR), and gender terms.||The 30, 45, 60....||||<0.001
72369516|NCT00740857|144249262|SUPERIORITY_OR_OTHER|||||||0.041|||||||ANOVA|With treatment, baseline Pain Severity Rating (PSR), and gender terms.||15 minutes||||0.041
72352818|NCT01521507|144225310|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Stage 1 primary and secondary outcomes were tested in order under a closed form testing method. Secondary outcome was tested only if primary outcome was statistically significant. If both outcomes were significant, overall study alpha was 0.025.|z-statistic|p-value was based on z-statistic of the sum of weighted average of difference in scores between groups at each site divided by the sum of the weights.||The null and alternative hypotheses are H0: µt ≤ µc vs. Ha: µt \> µc, where µt and µc are the mean changes in total meibomian gland scores from Baseline to 3 Months for the LipiFlow (test) and Warm Compress and Lid Hygiene (active control) groups, respectively. For the Stage 1 Primary Outcome, the minimum sample size was 24 subjects per group with a power of 90% and a one-sided alpha of 0.025.||||<0.0001
72352819|NCT01521507|144225310|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED||||||Mixed Models Analysis|||Supportive multivariate mixed model was also performed for this outcome controlling for significant demographic and baseline characteristics.||||0.0020
72352820|NCT01521507|144225311|SUPERIORITY_OR_OTHER|||||||0.9098|TWO_SIDED||||||Mixed Models Analysis|Stage 2 Primary Outcome was analyzed with a multivariate mixed model with the subgroup as a fixed effect while controlling for other covariates.||The null and alternative hypotheses for the Stage 2 Primary Outcome was: H0: µi= µj for all i and j where i≠j versus Ha: µi ≠ µj for at least one i and j, where µi is the mean total meibomian gland score at 12 Months for the ith subgroup. The null hypothesis was tested with a two-sided test at alpha=0.05. Since Stage 2 was an observational design, no minimum sample size was calculated for Stage 2.||||0.9098
72352821|NCT01521507|144225312|SUPERIORITY_OR_OTHER|||||||0.0068|TWO_SIDED|||||Stage 1 primary and secondary outcomes were tested in order under a closed form testing method. Secondary outcome was tested only if primary outcome was statistically significant. If both outcomes were significant, overall study alpha was 0.025.|t-test, 2 sided|||The null and alternative hypotheses are H0: µt ≤ µc vs. Ha: µt \> µc, where µt and µc are the mean changes in total OSDI scores from Baseline to 3 Months for the LipiFlow (test) and Warm Compress and Lid Hygiene (active control) groups, respectively. For the Stage 1 Secondary Outcome, the minimum sample size was 84 per group with a power of 80% and a one-sided alpha of 0.025.||||0.0068
72352822|NCT01521507|144225312|SUPERIORITY_OR_OTHER|||||||0.0419|TWO_SIDED||||||Mixed Models Analysis|||Supportive multivariate mixed model was also performed for this outcome controlling for significant demographic and baseline characteristics.||||0.0419
72352823|NCT01521507|144225313|SUPERIORITY_OR_OTHER|||||||0.0237|TWO_SIDED|||||Stage 2 Secondary Outcome was analyzed with a multivariate mixed model with the subgroup as a fixed effect while controlling for other covariates.|Mixed Models Analysis|||The null and alternative hypotheses for the Stage 2 Secondary Outcome was: H0: µi= µj for all i and j where i≠j versus Ha: µi ≠ µj for at least one i and j, where µi is the mean total OSDI score at 12 Months for the ith subgroup. The null hypothesis was tested with a two-sided test at alpha=0.05. Since Stage 2 was an observational design, no minimum sample size was calculated for Stage 2.||||0.0237
72352824|NCT00430716|144225367|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|24.15||||0.011|ONE_SIDED|97.5|3.37||||ANOVA|||An analysis of variance (ANOVA) model followed by the Williams trend test (one-sided, at the 2.5% level of significance) was used. The Williams trend test firstly determined if there was a significant downward trend in response for the descending doses, and then subsequently determined the highest dose that was statistically inferior to 20 mg (known to be an effective dose of sildenafil). A corresponding 97.5% lower confidence limit for the difference was presented.|||3.37|0.011
72352825|NCT00430716|144225367|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-1.17||||0.545|ONE_SIDED|97.5|-21.48||||ANOVA|||ANOVA model followed by the Williams trend test (one-sided, at the 2.5% level of significance) was used. The Williams trend test firstly determined if there was a significant downward trend in response for the descending doses, and then subsequently determined the highest dose that was statistically inferior to 20 mg (known to be an effective dose of sildenafil). A corresponding 97.5% lower confidence limit for the difference was presented.|||-21.48|0.545
72352826|NCT00430716|144225368|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-2.51||||0.278|TWO_SIDED|95.0|-7.07|2.05|||ANCOVA|||The analysis of change from baseline in week 12 mean PAP used Analysis of Covariance (ANCOVA), with etiology and baseline walking distance category (\<325m or \>=325m) and baseline score as the covariates. The mean difference and corresponding two-sided 95% CI for the comparisons of sildenafil 20 mg against the lower sildenafil dose (1 mg) was presented along with the p-value for the test.||2.05|-7.07|0.278
72352827|NCT00430716|144225368|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.44||||0.846|TWO_SIDED|95.0|-4.98|4.09|||ANCOVA|||The analysis of change from baseline in week 12 mean PAP used ANCOVA, with etiology and baseline walking distance category (\<325m or \>=325m) and baseline score as the covariates. The mean difference and corresponding two-sided 95% CI for the comparisons of sildenafil 20 mg against the lower sildenafil dose (5 mg) was presented along with the p-value for the test.||4.09|-4.98|0.846
72352828|NCT00430716|144225370|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.55||||0.448|TWO_SIDED|95.0|0.5|4.78|||Regression, Logistic|||The analysis of the week 12 PAH functional class was done with etiology, baseline walking distance category (\<325m or \>=325m) and baseline score as the covariates.The odds ratio and corresponding two-sided 95% CI for the odds ratio for the treatment comparisons was presented along with the p-value for the tests.||4.78|0.50|0.448
72352829|NCT00430716|144225370|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.08||||0.897|TWO_SIDED|95.0|0.35|3.32|||Regression, Logistic|||The analysis of the week 12 PAH functional class was done with etiology, baseline walking distance category (\<325m or \>=325m) and baseline score as the covariates.The odds ratio and corresponding two-sided 95% CI for the odds ratio for the treatment comparisons was presented along with the p-value for the tests.||3.32|0.35|0.897
72352830|NCT00430716|144225371|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-104.8||||0.005|TWO_SIDED|95.0|-177.44|-32.16|||ANCOVA|||ANCOVA method was used with etiology, baseline walking distance category (\<325m or \>=325m) and baseline score as the covariates. The mean difference and corresponding two-sided 95% CI for the comparisons of sildenafil 20 mg against the lower sildenafil dose (1 mg) was presented along with the p-value for the test.||-32.16|-177.44|0.005
72352831|NCT00430716|144225371|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-25.0||||0.496|TWO_SIDED|95.0|-97.5|47.5|||ANCOVA|||ANCOVA method was used with etiology, baseline walking distance category (\<325m or \>=325m) and baseline score as the covariates. The mean difference and corresponding two-sided 95% CI for the comparisons of sildenafil 20 mg against the lower sildenafil dose (5 mg) was presented along with the p-value for the test.||47.50|-97.50|0.496
72352832|NCT00430716|144225372|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-462.12||||0.009|TWO_SIDED|95.0|-807.53|-116.71|||ANCOVA|||ANCOVA method was used with etiology, baseline walking distance category (\<325m or \>=325m) and baseline score as the covariates. The mean difference and corresponding two-sided 95% CI for the comparisons of sildenafil 20 mg against the lower sildenafil dose (1 mg) was presented along with the p-value for the test.||-116.71|-807.53|0.009
72352833|NCT00430716|144225372|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Net)|-141.45||||0.414|TWO_SIDED|95.0|-483.48|200.58|||ANCOVA|||ANCOVA method was used with etiology, baseline walking distance category (\<325m or \>=325m) and baseline score as the covariates. The mean difference and corresponding two-sided 95% CI for the comparisons of sildenafil 20 mg against the lower sildenafil dose (5 mg) was presented along with the p-value for the test.||200.58|-483.48|0.414
72352834|NCT00430716|144225373|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.01||||0.89|TWO_SIDED|95.0|-0.17|0.15|||ANCOVA|||ANCOVA method was used with etiology, baseline walking distance category (\<325m or \>=325m) and baseline score as the covariates. The mean difference and corresponding two-sided 95% CI for the comparisons of sildenafil 20 mg against the lower sildenafil dose (1 mg) was presented along with the p-value for the test.||0.15|-0.17|0.890
72352835|NCT00430716|144225373|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.13||||0.124|TWO_SIDED|95.0|-0.29|0.04|||ANCOVA|||ANCOVA method was used with etiology, baseline walking distance category (\<325m or \>=325m) and baseline score as the covariates. The mean difference and corresponding two-sided 95% CI for the comparisons of sildenafil 20 mg against the lower sildenafil dose (5 mg) was presented along with the p-value for the test.||0.04|-0.29|0.124
72352836|NCT00430716|144225374|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Net)|0.0||||0.382|TWO_SIDED|95.0|-1.0|0.0|||Wilcoxon (Van-Elteren)|||A stratified Wilcoxon test (Van-Elteren) was used. The stratified median difference and corresponding two-sided 95% CI (calculated using the Hodges-Lehmann estimator) was presented along with the p-value for the test.||0.00|-1.00|0.382
72352837|NCT00430716|144225374|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.0||||0.141|TWO_SIDED|95.0|0.0|1.0|||Wilcoxon (Van-Elteren)|||A stratified Wilcoxon test (Van-Elteren) was used. The stratified median difference and corresponding two-sided 95% CI (calculated using the Hodges-Lehmann estimator) was presented along with the p-value for the test.||1.00|0.00|0.141
72352838|NCT01329978|144225380|SUPERIORITY_OR_OTHER||Difference in proportions|-1.4||||0.77|TWO_SIDED|95.0|-12.2|9.4||The p-value is based on the Cochran-Mantel-Haenszel (CMH) test stratified by randomization stratification factors.|Cochran-Mantel-Haenszel||The difference in proportions and its 95% confidence interval (CI) were calculated based on stratum-adjusted Mantel-Haenszel (MH) proportions.|The analyses was stratified by IL28B (CC versus any T allele) and plasma HCV RNA (\< 800,000 IU/mL versus ≥ 800,000 IU/mL). Only participants with genotype 1 were included in the comparison due to the fact that participants with genotype 4 and 6 were only enrolled in the SOF+PEG+RBV 24 weeks group.||9.4|-12.2|0.77
72352839|NCT01329978|144225380|SUPERIORITY_OR_OTHER||Difference in proportions|-0.4||||0.93|TWO_SIDED|95.0|-10.8|9.9||The p-value is based on the CMH test stratified by randomization stratification factors.|Cochran-Mantel-Haenszel|The difference in proportions and its 95% CI were calculated based on stratum-adjusted MH proportions.||The analyses was stratified by IL28B (CC versus any T allele) and plasma HCV RNA (\< 800,000 IU/mL versus ≥ 800,000 IU/mL).||9.9|-10.8|0.93
72352840|NCT03324802|144225402|SUPERIORITY|||||||1|||||||Log Rank|||||||1.0
72352841|NCT03324802|144225403|SUPERIORITY|||||||1|||||||Log Rank|||||||1.0
72352842|NCT03324802|144225405|SUPERIORITY|||||||0.32|||||||Chi-squared|||||||0.320
72352843|NCT03324802|144225406|SUPERIORITY|||||||0.163|||||||Chi-squared|||||||0.163
72352844|NCT03324802|144225407|SUPERIORITY|||||||0.97|||||||Log Rank|||||||0.97
72352845|NCT03324802|144225408|SUPERIORITY|||||||0.5|||||||Gray Test P-value|||||||0.5
72352846|NCT03324802|144225409|SUPERIORITY|||||||0.54|||||||Log Rank|||||||0.54
72352847|NCT00773513|144225419|NON_INFERIORITY|The critical alpha level for the non-inferiority test was 0.025.|Hazard Ratio (HR)|1.03||||0.0039|TWO_SIDED|95.0|0.93|1.15|||Regression, Cox||The pre-specified upper non-inferiority limit was 95% CI \<1.20.|||1.15|0.93|0.0039
72352848|NCT00773513|144225420|NON_INFERIORITY|The critical alpha level for the non-inferiority test was 0.025|Hazard Ratio (HR)|1.06||||0.0166|TWO_SIDED|95.0|0.94|1.19|||Regression, Cox|||||1.19|0.94|0.0166
72352849|NCT00773513|144225421|NON_INFERIORITY|The critical alpha level for the non-inferiority test was 0.025|Hazard Ratio (HR)|0.95||||0.0219|TWO_SIDED|95.0|0.76|1.19|||Regression, Cox|||||1.19|0.76|0.0219
72352850|NCT00773513|144225422|NON_INFERIORITY|The critical alpha level for the non-inferiority test was 0.025|Hazard Ratio (HR)|0.94||||0.0459|TWO_SIDED|95.0|0.7|1.25|||Regression, Cox|||||1.25|0.70|0.0459
72352851|NCT00773513|144225423|NON_INFERIORITY|The critical alpha level for the non-inferiority test was 0.025|Hazard Ratio (HR)|0.91||||0.0048|TWO_SIDED|95.0|0.74|1.12|||Regression, Cox|||||1.12|0.74|0.0048
72352852|NCT04170543|144225429|OTHER||LS Mean Difference in Percent Change|-2.85||||0.8338|TWO_SIDED|90.0|-22.61|21.94||Unadjusted two-sided p-value|MMRM||MEDI3506 30 mg - Placebo|||21.94|-22.61|0.8338
72352853|NCT04170543|144225429|OTHER||LS Mean Difference in Percent Change|-19.52||||0.1169|TWO_SIDED|90.0|-35.92|1.07||Unadjusted two-sided p-value|MMRM||MEDI3506 60 mg - Placebo|||1.07|-35.92|0.1169
72352854|NCT04170543|144225429|OTHER||LS Mean Difference in Percent Change|-17.47||||0.1774|TWO_SIDED|90.0|-34.71|4.32||Unadjusted two-sided p-value|MMRM||MEDI3506 120 mg - Placebo|||4.32|-34.71|0.1774
72352855|NCT04170543|144225429|OTHER||LS Mean Difference in Percent Change|-7.22||||0.5379|TWO_SIDED|90.0|-24.05|13.35||Unadjusted two-sided p-value|MMRM|||||13.35|-24.05|0.5379
72352856|NCT04170543|144225430|OTHER||LS Mean Difference in Percent Change|-13.02||||0.1929|TWO_SIDED|90.0|-27.08|3.75||Unadjusted two-sided p-value|MMRM||MEDI3506 30 mg - Placebo|||3.75|-27.08|0.1929
72352857|NCT04170543|144225430|OTHER||LS Mean Difference in Percent Change|-25.71||||0.0062|TWO_SIDED|90.0|-37.83|-11.22||Unadjusted two-sided p-value|MMRM||MEDI3506 60 mg - Placebo|||-11.22|-37.83|0.0062
72352858|NCT04170543|144225430|OTHER||LS Mean Difference in Percent Change|-18.2||||0.0705|TWO_SIDED|90.0|-31.86|-1.81||Unadjusted two-sided p-value|MMRM||MEDI3506 120 mg - Placebo|||-1.81|-31.86|0.0705
72352859|NCT04170543|144225430|OTHER||LS Mean Difference in Percent Change|-15.56||||0.0764|TWO_SIDED|90.0|-27.82|-1.21||Unadjusted two-sided p-value|MMRM|||||-1.21|-27.82|0.0764
72352860|NCT04170543|144225431|OTHER||LS Mean Difference in Percent Change|7.25||||0.5474|TWO_SIDED|90.0|-11.45|29.88||Unadjusted two-sided p-value|MMRM||MEDI3506 30 mg - Placebo|||29.88|-11.45|0.5474
72352861|NCT04170543|144225431|OTHER||LS Mean Difference in Percent Change|3.11||||0.792|TWO_SIDED|90.0|-14.83|24.82||Unadjusted two-sided p-value|MMRM||MEDI3506 60 mg - Placebo|||24.82|-14.83|0.7920
72352862|NCT04170543|144225431|OTHER||LS Mean Difference in Percent Change|-3.4||||0.7711|TWO_SIDED|90.0|-20.59|17.51||Unadjusted two-sided p-value|MMRM||MEDI3506 120 mg - Placebo|||17.51|-20.59|0.7711
72352863|NCT04170543|144225431|OTHER||LS Mean Difference in Percent Change|5.27||||0.6163|TWO_SIDED|90.0|-11.08|24.62||Unadjusted two-sided p-value|MMRM|||||24.62|-11.08|0.6163
72352864|NCT04170543|144225433|OTHER||LS Mean Difference in Percent Change|2.43||||0.8537|TWO_SIDED|90.0|-17.35|26.95||Unadjusted two-sided p-value|MMRM||MEDI3506 30 mg - Placebo|||26.95|-17.35|0.8537
72352865|NCT04170543|144225433|OTHER||LS Mean Difference in Percent Change|-15.63||||0.1989|TWO_SIDED|90.0|-32.14|4.89||Unadjusted two-sided p-value|MMRM||MEDI3506 60 mg - Placebo|||4.89|-32.14|0.1989
72352866|NCT04170543|144225433|OTHER||LS Mean Difference in Percent Change|-17.96||||0.1346|TWO_SIDED|90.0|-34.01|1.99||Unadjusted two-sided p-value|MMRM||MEDI3506 120 mg - Placebo|||1.99|-34.01|0.1346
72352867|NCT04170543|144225433|OTHER||LS Mean Difference in Percent Change|-6.38||||0.5683|TWO_SIDED|90.0|-22.59|13.23||Unadjusted two-sided p-value|MMRM|||||13.23|-22.59|0.5683
72352868|NCT04170543|144225434|OTHER||LS Mean Difference in Percent Change|-7.93||||0.4226|TWO_SIDED|90.0|-22.3|9.1||Unadjusted two-sided p-value|MMRM||MEDI3506 30 mg - Placebo|||9.10|-22.30|0.4226
72352869|NCT04170543|144225434|OTHER||LS Mean Difference in Percent Change|-20.61||||0.0287|TWO_SIDED|90.0|-33.25|-5.58||Unadjusted two-sided p-value|MMRM||MEDI3506 60 mg - Placebo|||-5.58|-33.25|0.0287
72352870|NCT04170543|144225434|OTHER||LS Mean Difference in Percent Change|-18.73||||0.0498|TWO_SIDED|90.0|-31.7|-3.3||Unadjusted two-sided p-value|MMRM||MEDI3506 120 mg - Placebo|||-3.30|-31.70|0.0498
72352871|NCT04170543|144225434|OTHER||LS Mean Difference in Percent Change|-13.27||||0.1236|TWO_SIDED|90.0|-25.51|0.98||Unadjusted two-sided p-value|MMRM|||||0.98|-25.51|0.1236
72352872|NCT03890588|144225443|SUPERIORITY||Risk Ratio (RR)|1.17|STANDARD_ERROR_OF_MEAN|0.12||0.21|TWO_SIDED|95.0|0.91|1.51|||Mixed Models Analysis|||||1.51|.91|.21
72352873|NCT03890588|144225444|SUPERIORITY||Risk Ratio (RR)|0.95|STANDARD_ERROR_OF_MEAN|0.11||0.61|TWO_SIDED|95.0|0.76|1.18|||Mixed Models Analysis|||||1.18|.76|.61
72352874|NCT03890588|144225445|SUPERIORITY||Risk Ratio (RR)|0.98|STANDARD_ERROR_OF_MEAN|0.08||0.84|TWO_SIDED|95.0|0.84|1.15|||Mixed Models Analysis|||||1.15|0.84|.84
72352875|NCT03890588|144225446|SUPERIORITY||Risk Ratio (RR)|1.0|STANDARD_ERROR_OF_MEAN|0.11||0.99|TWO_SIDED|95.0|0.8|1.24|||Mixed Models Analysis|||||1.24|.8|.99
72352876|NCT03890588|144225447|SUPERIORITY||Risk Ratio (RR)|1.02|STANDARD_ERROR_OF_MEAN|0.12||0.86|TWO_SIDED|95.0|0.79|1.32|||Mixed Models Analysis|||||1.32|.79|.86
72352877|NCT00452790|144225469|SUPERIORITY_OR_OTHER|||||||0.483||95.0|||||Fisher Exact|||Difference in incidence rates of tenderness-any within 4 days of the infant series dose 1 (6 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.483
72352878|NCT00452790|144225469|SUPERIORITY_OR_OTHER|||||||0.698||95.0|||||Fisher Exact|||Difference in incidence rates of tenderness-significant within 4 days of the infant series dose 1 (6 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.698
72352879|NCT00452790|144225469|SUPERIORITY_OR_OTHER|||||||0.782||95.0|||||Fisher Exact|||Difference in incidence rates of induration-any within 4 days of the infant series dose 1 (6 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.782
72352880|NCT00452790|144225469|SUPERIORITY_OR_OTHER||||||>|0.99||95.0|||||Fisher Exact|||Difference in incidence rates of induration-mild within 4 days of the infant series dose 1 (6 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||>0.99
72352881|NCT00452790|144225469|SUPERIORITY_OR_OTHER|||||||0.729||95.0|||||Fisher Exact|||Difference in incidence rates of induration-moderate within 4 days of the infant series dose 1 (6 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.729
72352882|NCT00452790|144225469|SUPERIORITY_OR_OTHER|||||||||95.0|||||Fisher Exact|||Difference in incidence rates of Induration-Severe within 4 days of the infant series dose 1 (6 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||
72352883|NCT00452790|144225469|SUPERIORITY_OR_OTHER|||||||0.819||95.0|||||Fisher Exact|||Difference in incidence rates of Erythema-Any within 4 days of the infant series dose 1 (6 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.819
72352884|NCT00452790|144225469|SUPERIORITY_OR_OTHER|||||||0.904||95.0|||||Fisher Exact|||Difference in incidence rates of erythema-mild within 4 days of the infant series dose 1 (6 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.904
72352885|NCT00452790|144225469|SUPERIORITY_OR_OTHER||||||>|0.99||95.0|||||Fisher Exact|||Difference in incidence rates of Erythema-Moderate within 4 days of the infant series dose 1 (6 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||>0.99
72352886|NCT00452790|144225469|SUPERIORITY_OR_OTHER|||||||||95.0|||||Fisher Exact|||Difference in incidence rates of erythema-severe within 4 days of the infant series dose 1 (6 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||
72352887|NCT00452790|144225469|SUPERIORITY_OR_OTHER|||||||0.69||95.0|||||Fisher Exact|||Difference in incidence rates of any local reaction (tenderness, induration and erythema) within 4 days of the infant series dose 1 (6 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.690
72352888|NCT00452790|144225470|SUPERIORITY_OR_OTHER|||||||0.933||95.0|||||Fisher Exact|||Difference in incidence rates of tenderness-any within 4 days of the infant series dose 2 (10 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.933
72352889|NCT00452790|144225470|SUPERIORITY_OR_OTHER|||||||0.776||95.0|||||Fisher Exact|||Difference in incidence rates of tenderness-significant within 4 days of the infant series dose 2 (10 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.776
72352890|NCT00452790|144225470|SUPERIORITY_OR_OTHER|||||||0.596||95.0|||||Fisher Exact|||Difference in incidence rates of induration-any within 4 days of the infant series dose 2 (10 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.596
72352891|NCT00452790|144225470|SUPERIORITY_OR_OTHER|||||||0.909||95.0|||||Fisher Exact|||Difference in incidence rates of induration-mild within 4 days of the infant series dose 2 (10 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.909
72352892|NCT00452790|144225470|SUPERIORITY_OR_OTHER|||||||0.683||95.0|||||Fisher Exact|||Difference in incidence rates of induration-moderate within 4 days of the infant series dose 2 (10 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.683
72352893|NCT00452790|144225470|SUPERIORITY_OR_OTHER|||||||||95.0|||||Fisher Exact|||Difference in incidence rates of induration-severe within 4 days of the infant series dose 2 (10 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||
72352894|NCT00452790|144225470|SUPERIORITY_OR_OTHER|||||||0.203||95.0|||||Fisher Exact|||Difference in incidence rates of erythema-any within 4 days of the infant series dose 2 (10 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.203
72352895|NCT00452790|144225470|SUPERIORITY_OR_OTHER|||||||0.399||95.0|||||Fisher Exact|||Difference in incidence rates of Erythema-Mild within 4 days of the infant series dose 2 (10 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.399
72352896|NCT00452790|144225470|SUPERIORITY_OR_OTHER|||||||0.382||95.0|||||Fisher Exact|||Difference in incidence rates of erythema-moderate within 4 days of the infant series dose 2 (10 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.382
72352897|NCT00452790|144225470|SUPERIORITY_OR_OTHER|||||||||95.0|||||Fisher Exact|||Difference in incidence rates of erythema-severe within 4 days of the infant series dose 2 (10 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||
72352898|NCT00452790|144225470|SUPERIORITY_OR_OTHER|||||||0.738||95.0|||||Fisher Exact|||Difference in incidence rates of any Local reaction (tenderness, induration, erythema) within 4 days of the infant series dose 2 (10 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.738
72352899|NCT00452790|144225471|SUPERIORITY_OR_OTHER|||||||0.918||95.0|||||Fisher Exact|||Difference in incidence rates of tenderness-any within 4 days of the infant series dose 3 (14 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.918
72352900|NCT00452790|144225471|SUPERIORITY_OR_OTHER|||||||0.906||95.0|||||Fisher Exact|||Difference in incidence rates of tenderness-significant within 4 days of the infant series dose 3 (14 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.906
72352901|NCT00452790|144225471|SUPERIORITY_OR_OTHER|||||||0.404||95.0|||||Fisher Exact|||Difference in incidence rates of induration-any within 4 days of the infant series dose 3 (14 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.404
72352902|NCT00452790|144225471|SUPERIORITY_OR_OTHER|||||||0.305||95.0|||||Fisher Exact|||Difference in incidence rates of induration-mild within 4 days of the infant series dose 3 (14 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.305
72352903|NCT00452790|144225471|SUPERIORITY_OR_OTHER|||||||0.771||95.0|||||Fisher Exact|||Difference in incidence rates of induration-moderate within 4 days of the infant series dose 3 (14 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.771
72352904|NCT00452790|144225471|SUPERIORITY_OR_OTHER|||||||||95.0|||||Fisher Exact|||Difference in incidence rates of induration-severe within 4 days of the infant series dose 3 (14 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||
72352905|NCT00452790|144225471|SUPERIORITY_OR_OTHER|||||||0.867||95.0|||||Fisher Exact|||Difference in incidence rates of erythema-any within 4 days of the infant series dose 3 (14 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.867
72352906|NCT00452790|144225471|SUPERIORITY_OR_OTHER|||||||0.735||95.0|||||Fisher Exact|||Difference in incidence rates of erythema-mild within 4 days of the infant series dose 3 (14 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.735
72352907|NCT00452790|144225471|SUPERIORITY_OR_OTHER||||||>|0.99||95.0|||||Fisher Exact|||Difference in incidence rates of erythema-moderate within 4 days of the infant series dose 3 (14 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||>0.99
72352908|NCT00452790|144225471|SUPERIORITY_OR_OTHER|||||||||95.0|||||Fisher Exact|||Difference in incidence rates of erythema-severe within 4 days of the infant series dose 3 (14 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||
72352909|NCT00452790|144225471|SUPERIORITY_OR_OTHER|||||||0.842||95.0|||||Fisher Exact|||Difference in incidence rates of any Local Reaction (tenderness, induration, erythema) within 4 days of the infant series dose 3 (14 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.842
72352910|NCT00452790|144225472|SUPERIORITY_OR_OTHER|||||||0.908||95.0|||||Fisher Exact|||Difference in incidence rates of tenderness-any within 4 days of the toddler dose, dose 4 (12 months of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.908
72352911|NCT00452790|144225472|SUPERIORITY_OR_OTHER|||||||0.772||95.0|||||Fisher Exact|||Difference in incidence rates of tenderness-significant within 4 days of the toddler dose, dose 4(12 months of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.772
72352912|NCT00452790|144225472|SUPERIORITY_OR_OTHER|||||||0.681||95.0|||||Fisher Exact|||Difference in incidence rates of induration-any within 4 days of the toddler dose, dose 4 (12 months of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.681
72352913|NCT00452790|144225472|SUPERIORITY_OR_OTHER|||||||0.881||95.0|||||Fisher Exact|||Difference in incidence rates of induration-mild within 4 days of the toddler dose, dose 4 (12 months of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.881
72352914|NCT00452790|144225472|SUPERIORITY_OR_OTHER|||||||0.509||95.0|||||Fisher Exact|||Difference in incidence rates of induration-moderate within 4 days of the toddler dose, dose 4 (12 months of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.509
72352915|NCT00452790|144225472|SUPERIORITY_OR_OTHER|||||||||95.0|||||Fisher Exact|||Difference in incidence rates of induration-severe within 4 days of the toddler dose (12 months of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||
72352916|NCT00452790|144225472|SUPERIORITY_OR_OTHER|||||||0.88||95.0|||||Fisher Exact|||Difference in incidence rates of erythema-any within 4 days of the toddler dose, dose 4 (12 months of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.880
72352917|NCT00452790|144225472|SUPERIORITY_OR_OTHER|||||||0.739||95.0|||||Fisher Exact|||Difference in incidence rates of erythema-mild within 4 days of the toddler dose, dose 4 (12 months of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.739
72352918|NCT00452790|144225472|SUPERIORITY_OR_OTHER||||||>|0.99||95.0|||||Fisher Exact|||Difference in incidence rates of erythema-moderate within 4 days of the toddler dose, dose 4 (12 months of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||>0.99
72352919|NCT00452790|144225472|SUPERIORITY_OR_OTHER|||||||||95.0|||||Fisher Exact|||Difference in incidence rates of erythema-severe within 4 days of the toddler dose, dose 4 (12 months of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||
72352920|NCT00452790|144225472|SUPERIORITY_OR_OTHER|||||||0.446||95.0|||||Fisher Exact|||Difference in incidence rates of any local reaction (tenderness, induration, erythema) within 4 days of the toddler dose, dose 4 (12 months of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.446
72352921|NCT00452790|144225473|SUPERIORITY_OR_OTHER|||||||0.625||95.0|||||Fisher Exact|||Difference in incidence rates of fever \>=38 but \<=39 degrees C within 4 days of the infant series dose 1 (6 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.625
72352922|NCT00452790|144225473|SUPERIORITY_OR_OTHER|||||||0.375||95.0|||||Fisher Exact|||Difference in incidence rates of fever \>39 but \<=40 degrees C within 4 days of the infant series dose 1 (6 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.375
72352923|NCT00452790|144225473|SUPERIORITY_OR_OTHER|||||||0.624||95.0|||||Fisher Exact|||Difference in incidence rates of fever \>40 degrees C within 4 days of the infant series dose 1 (6 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.624
72352924|NCT00452790|144225473|SUPERIORITY_OR_OTHER||||||>|0.99||95.0|||||Fisher Exact|||Difference in incidence rates of decreased appetite within 4 days of the infant series dose 1 (6 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||>0.99
72352925|NCT00452790|144225473|SUPERIORITY_OR_OTHER|||||||0.282||95.0|||||Fisher Exact|||Difference in incidence rates of irritability within 4 days of the infant series dose 1 (6 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.282
72352926|NCT00452790|144225473|SUPERIORITY_OR_OTHER|||||||0.307||95.0|||||Fisher Exact|||Difference in incidence rates of Increased sleep within 4 days of the infant series dose 1 (6 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.307
72352927|NCT00452790|144225473|SUPERIORITY_OR_OTHER|||||||0.939||95.0|||||Fisher Exact|||Difference in incidence rates of decreased sleep within 4 days of the infant series dose 1 (6 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.939
72352928|NCT00452790|144225473|SUPERIORITY_OR_OTHER|||||||0.085||95.0|||||Fisher Exact|||Difference in incidence rates of any systemic event (fever, decrease in appetite, irritability, increased or decreased sleep) within 4 days of the infant series dose 1 (6 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.085
72352929|NCT00452790|144225474|SUPERIORITY_OR_OTHER|||||||0.111||95.0|||||Fisher Exact|||Difference in incidence rates of fever \>= 38 but \<= 39 degrees C within 4 days of the infant series dose 2 (10 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.111
72352930|NCT00452790|144225474|SUPERIORITY_OR_OTHER||||||>|0.99||95.0|||||Fisher Exact|||Difference in incidence rates of fever \>39 but \<= 40 degrees C within 4 days of the infant series dose 2 (10 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||>0.99
72352931|NCT00452790|144225474|SUPERIORITY_OR_OTHER|||||||0.488||95.0|||||Fisher Exact|||Difference in incidence rates of fever \>40 degrees C within 4 days of the infant series dose 2 (10 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.488
72352932|NCT00452790|144225474|SUPERIORITY_OR_OTHER|||||||0.736||95.0|||||Fisher Exact|||Difference in incidence rates of Decreased appetite within 4 days of the infant series dose 2 (10 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.736
72352933|NCT00452790|144225474|SUPERIORITY_OR_OTHER|||||||0.856||95.0|||||Fisher Exact|||Difference in incidence rates of Irritability within 4 days of the infant series dose 2 (10 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.856
72352934|NCT00452790|144225474|SUPERIORITY_OR_OTHER|||||||0.098||95.0|||||Fisher Exact|||Difference in incidence rates of Increased sleep within 4 days of the infant series dose 2 (10 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.098
72352935|NCT00452790|144225474|SUPERIORITY_OR_OTHER|||||||0.034||95.0|||||Fisher Exact|||Difference in incidence rates of Decreased sleep within 4 days of the infant series dose 2 (10 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.034
72352936|NCT00452790|144225474|SUPERIORITY_OR_OTHER||||||>|0.99||95.0|||||Fisher Exact|||Difference in incidence rates of Any systemic event (fever, decrease in appetite, irritability, increased or decreased sleep) within 4 days of the infant series dose 2 (10 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||>0.99
72352937|NCT00452790|144225475|SUPERIORITY_OR_OTHER|||||||0.085||95.0|||||Fisher Exact|||Difference in incidence rates of fever \>= 38 but \<= 39 degrees C within 4 days of the infant series dose 3 (14 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.085
72352938|NCT00452790|144225475|SUPERIORITY_OR_OTHER|||||||||95.0|||||Fisher Exact|||Difference in incidence rates of fever \>39 but \<= 40 degrees C within 4 days of the infant series dose 3 (14 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||
72352939|NCT00452790|144225475|SUPERIORITY_OR_OTHER|||||||0.489||95.0|||||Fisher Exact|||Difference in incidence rates of fever \>40 degrees C within 4 days of the infant series dose 3 (14 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.489
72352940|NCT00452790|144225475|SUPERIORITY_OR_OTHER|||||||0.84||95.0|||||Fisher Exact|||Difference in incidence rates of decreased appetite within 4 days of the infant series dose 3 (14 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.840
72352941|NCT00452790|144225475|SUPERIORITY_OR_OTHER|||||||0.605||95.0|||||Fisher Exact|||Difference in incidence rates of irritability within 4 days of the infant series dose 3 (14 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.605
72352942|NCT00452790|144225475|SUPERIORITY_OR_OTHER||||||>|0.99||95.0|||||Fisher Exact|||Difference in incidence rates of increased sleep within 4 days of the infant series dose 3 (14 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||>0.99
72352943|NCT00452790|144225475|SUPERIORITY_OR_OTHER|||||||0.265||95.0|||||Fisher Exact|||Difference in incidence rates of decreased sleep within 4 days of the infant series dose 3 (14 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.265
72352944|NCT00452790|144225475|SUPERIORITY_OR_OTHER|||||||0.422||95.0|||||Fisher Exact|||Difference in incidence rates of any systemic event (fever, decrease in appetite, irritability, increased or decreased sleep) within 4 days of the infant series dose 3 (14 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.422
72352945|NCT00452790|144225476|SUPERIORITY_OR_OTHER|||||||0.815||95.0|||||Fisher Exact|||Difference in incidence rates of fever \>= 38 but \<= 39 degrees within 4 days of the toddler dose, dose 4 (12 months of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.815
72352946|NCT00452790|144225476|SUPERIORITY_OR_OTHER||||||>|0.99||95.0|||||Fisher Exact|||Difference in incidence rates of fever \>39 but \<= 40 degrees within 4 days of the toddler dose, dose 4 (12 months of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||>0.99
72352947|NCT00452790|144225476|SUPERIORITY_OR_OTHER|||||||||95.0|||||Fisher Exact|||Difference in incidence rates of fever \>40 degrees C within 4 days of the toddler dose, dose 4 (12 months of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||
72352948|NCT00452790|144225476|SUPERIORITY_OR_OTHER|||||||0.401||95.0|||||Fisher Exact|||Difference in incidence rates of decreased appetite within 4 days of the toddler dose, dose 4 (12 months of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.401
72352949|NCT00452790|144225476|SUPERIORITY_OR_OTHER|||||||0.511||95.0|||||Fisher Exact|||Difference in incidence rates of irritability within 4 days of the toddler dose, dose 4 (12 months of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.511
72352950|NCT00452790|144225476|SUPERIORITY_OR_OTHER|||||||0.487||95.0|||||Fisher Exact|||Difference in incidence rates of increased sleep within 4 days of the toddler dose, dose 4 (12 months of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.487
72352951|NCT00452790|144225476|SUPERIORITY_OR_OTHER|||||||0.388||95.0|||||Fisher Exact|||Difference in incidence rates of decreased sleep within 4 days of the toddler dose, dose 4 (12 months of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.388
72352952|NCT00452790|144225476|SUPERIORITY_OR_OTHER|||||||0.753||95.0|||||Fisher Exact|||Difference in incidence rates of any systemic event fever, decrease in appetite, irritability, increased or decreased sleep) within 4 days of the toddler dose, dose 4 (12 months of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.753
72352953|NCT00549445|144225524|OTHER|Student t test||||||0.045||||||Threshold for significance is P-Value \< 0.05|t-test, 1 sided|||||||0.045
72352954|NCT04437485|144225534|SUPERIORITY|||||||0.64|||||||ANCOVA|ANCOVA models were run on post-treatment outcome level adjusting for baseline somatic depressive symptoms group (a stratification variable).||||||0.64
72352955|NCT04437485|144225535|SUPERIORITY|||||||0.046|||||||ANCOVA|ANCOVA models were run on post-treatment outcome level adjusting for baseline somatic depressive symptoms group (a stratification variable).||||||0.046
72352956|NCT04437485|144225536|SUPERIORITY|||||||0.09|||||||ANCOVA|ANCOVA models were run on post-treatment outcome level adjusting for baseline somatic depressive symptoms group (a stratification variable).||||||0.09
72352957|NCT02719171|144225537|OTHER||Mean Difference (Final Values)|24.0||||0.007|TWO_SIDED|90.0|9.3|38.7|||Cochran-Mantel-Haenszel|||The 90% confidence interval (CI) for the difference in response rates between the groups and the 2-sided p-value are calculated using the Cochran Mantel-Haenszel method, stratified by prior tumor necrosis factor inhibitor (TNFi) use and concurrent methotrexate use.||38.7|9.3|0.007
72352958|NCT02719171|144225538|OTHER||Mean Difference (Final Values)|12.0||||0.074|TWO_SIDED|90.0|1.0|23.0|||Cochran-Mantel-Haenszel|||The 90% CI for the difference in response rates between the groups and the 2-sided p-value are calculated using the Cochran Mantel-Haenszel method, stratified by prior TNFi use and concurrent methotrexate use.||23.0|1.0|0.074
72352959|NCT02719171|144225538|OTHER||Mean Difference (Final Values)|19.0||||0.007|TWO_SIDED|90.0|7.4|30.6|||Cochran-Mantel-Haenszel|||The 90% CI for the difference in response rates between the groups and the 2-sided p-value are calculated using the Cochran Mantel-Haenszel method, stratified by prior TNFi use and concurrent methotrexate use.||30.6|7.4|0.007
72352960|NCT02719171|144225539|OTHER||Mean Difference (Final Values)|10.3||||0.006|TWO_SIDED|90.0|4.1|16.4|||Cochran-Mantel-Haenszel|||The 90% CI for the difference in response rates between the groups and the 2-sided p-value are calculated using the Cochran Mantel-Haenszel method, stratified by prior TNFi use and concurrent methotrexate use.||16.4|4.1|0.006
72352961|NCT02719171|144225539|OTHER||Mean Difference (Final Values)|15.7|||<|0.001|TWO_SIDED|90.0|8.5|22.9|||Cochran-Mantel-Haenszel|||The 90% CI for the difference in response rates between the groups and the 2-sided p-value are calculated using the Cochran Mantel-Haenszel method, stratified by prior TNFi use and concurrent methotrexate use.||22.9|8.5|<0.001
72352962|NCT02719171|144225540|OTHER||Mean Difference (Final Values)|-0.8||||0.69|TWO_SIDED|90.0|-4.0|2.5|||mixed model repeated measures model|||The 2-sided p-value is calculated using a mixed model repeated measures model with categorical fixed effects of treatment, stratification factors, week, and treatment-by-week interaction and the continuous fixed baseline measurement, with subject as a random effect.||2.5|-4.0|0.690
72352963|NCT02719171|144225540|OTHER||Mean Difference (Final Values)|-2.1||||0.26|TWO_SIDED|90.0|-5.3|1.0|||mixed model repeated measures model|||The 2-sided p-value is calculated using a mixed model repeated measures model with categorical fixed effects of treatment, stratification factors, week, and treatment-by-week interaction and the continuous fixed baseline measurement, with subject as a random effect.||1.0|-5.3|0.260
72352964|NCT02719171|144225541|OTHER||Mean Difference (Final Values)|-0.3||||0.791|TWO_SIDED|90.0|-2.1|1.5|||Cochran-Mantel-Haenszel|||The 2-sided p-value is calculated using a mixed model repeated measures model with categorical fixed effects of treatment, stratification factors, week, and treatment-by-week interaction and the continuous fixed baseline measurement, with subject as a random effect.||1.5|-2.1|0.791
72352965|NCT02719171|144225541|OTHER||Mean Difference (Final Values)|-1.1||||0.32|TWO_SIDED|90.0|-2.8|0.7|||mixed model repeated measures model|||The 2-sided p-value is calculated using a mixed model repeated measures model with categorical fixed effects of treatment, stratification factors, week, and treatment-by-week interaction and the continuous fixed baseline measurement, with subject as a random effect.||0.7|-2.8|0.320
72352966|NCT02719171|144225542|OTHER||mixed model repeated measures model|-0.082||||0.341|TWO_SIDED|90.0|-0.225|0.06|||mixed model repeated measures model|||The 2-sided p-value is calculated using a mixed model repeated measures model with categorical fixed effects of treatment, stratification factors, week, and treatment-by-week interaction and the continuous fixed baseline measurement, with subject as a random effect.||0.060|-0.225|0.341
72352967|NCT02719171|144225542|OTHER||Mean Difference (Final Values)|-0.114||||0.181|TWO_SIDED|90.0|-0.254|0.027|||mixed model repeated measures model|||The 2-sided p-value is calculated using a mixed model repeated measures model with categorical fixed effects of treatment, stratification factors, week, and treatment-by-week interaction and the continuous fixed baseline measurement, with subject as a random effect.||0.027|-0.254|0.181
72352968|NCT02719171|144225543|OTHER||Mean Difference (Final Values)|1.7||||0.174|TWO_SIDED|90.0|-0.36|3.77|||mixed model repeated measures model|||The 2-sided p-value is calculated using a mixed model repeated measures model with categorical fixed effects of treatment, stratification factors, week, and treatment-by-week interaction and the continuous fixed baseline measurement, with subject as a random effect.||3.77|-0.36|0.174
72352969|NCT02719171|144225543|OTHER||Mean Difference (Final Values)|1.35||||0.284|TWO_SIDED|90.0|-0.73|3.44|||mixed model repeated measures model|||The 2-sided p-value is calculated using a mixed model repeated measures model with categorical fixed effects of treatment, stratification factors, week, and treatment-by-week interaction and the continuous fixed baseline measurement, with subject as a random effect.||3.44|-0.73|0.284
72352970|NCT02719171|144225544|OTHER||Mean Difference (Final Values)|0.59||||0.718|TWO_SIDED|90.0|-2.12|3.3|||mixed model repeated measures model|||The 2-sided p-value is calculated using a mixed model repeated measures model with categorical fixed effects of treatment, stratification factors, week, and treatment-by-week interaction and the continuous fixed baseline measurement, with subject as a random effect.||3.30|-2.12|0.718
72352971|NCT02719171|144225544|OTHER||Mean Difference (Final Values)|2.06||||0.204|TWO_SIDED|90.0|-0.61|4.74|||mixed model repeated measures model|||The 2-sided p-value is calculated using a mixed model repeated measures model with categorical fixed effects of treatment, stratification factors, week, and treatment-by-week interaction and the continuous fixed baseline measurement, with subject as a random effect.||4.74|-0.61|0.204
72352972|NCT02719171|144225545|OTHER||Mean Difference (Final Values)|1.2||||0.243|TWO_SIDED|90.0|-0.5|2.8|||mixed model repeated measures model|||The 2-sided p-value is calculated using a mixed model repeated measures model with categorical fixed effects of treatment, stratification factors, week, and treatment-by-week interaction and the continuous fixed baseline measurement, with subject as a random effect.||2.8|-0.5|0.243
72352973|NCT02719171|144225545|OTHER||Mean Difference (Final Values)|0.1||||0.906|TWO_SIDED|90.0|-1.0|1.1|||mixed model repeated measures model|||The 2-sided p-value is calculated using a mixed model repeated measures model with categorical fixed effects of treatment, stratification factors, week, and treatment-by-week interaction and the continuous fixed baseline measurement, with subject as a random effect.||1.1|-1.0|0.906
72352974|NCT02719171|144225546|OTHER||Mean Difference (Final Values)|-0.7||||0.325|TWO_SIDED|90.0|-1.8|0.5|||mixed model repeated measures model|||The 2-sided p-value is calculated using a mixed model repeated measures model with categorical fixed effects of treatment, stratification factors, week, and treatment-by-week interaction and the continuous fixed baseline measurement, with subject as a random effect.||0.5|-1.8|0.325
72352975|NCT02719171|144225546|OTHER||Mean Difference (Final Values)|-0.9||||0.16|TWO_SIDED|90.0|-2.1|0.2|||mixed model repeated measures model|||The 2-sided p-value is calculated using a mixed model repeated measures model with categorical fixed effects of treatment, stratification factors, week, and treatment-by-week interaction and the continuous fixed baseline measurement, with subject as a random effect.||0.2|-2.1|0.160
72352976|NCT02719171|144225547|OTHER||Mean Difference (Final Values)|-1.2||||0.453|TWO_SIDED|90.0|-4.0|1.5|||mixed model repeated measures model|||The 2-sided p-value is calculated using a mixed model repeated measures model with categorical fixed effects of treatment, stratification factors, week, and treatment-by-week interaction and the continuous fixed baseline measurement, with subject as a random effect.||1.5|-4.0|0.453
72352977|NCT02719171|144225547|OTHER||Mean Difference (Final Values)|-2.8||||0.111|TWO_SIDED|90.0|-5.7|0.1|||mixed model repeated measures model|||The 2-sided p-value is calculated using a mixed model repeated measures model with categorical fixed effects of treatment, stratification factors, week, and treatment-by-week interaction and the continuous fixed baseline measurement, with subject as a random effect.||0.1|-5.7|0.111
72352978|NCT02719171|144225548|OTHER||Mean Difference (Final Values)|53.5|||<|0.001|TWO_SIDED|90.0|35.9|71.1|||Cochran-Mantel-Haenszel|||The 90% CI for the difference in response rates between the groups and the 2-sided p-value are calculated using the Cochran Mantel-Haenszel method, stratified by prior TNFi use and concurrent methotrexate use.||71.1|35.9|<0.001
72352979|NCT02719171|144225548|OTHER||Mean Difference (Final Values)|48.8|||<|0.001|TWO_SIDED|90.0|33.1|64.5|||Cochran-Mantel-Haenszel|||The 90% CI for the difference in response rates between the groups and the 2-sided p-value are calculated using the Cochran Mantel-Haenszel method, stratified by prior TNFi use and concurrent methotrexate use.||64.5|33.1|<0.001
72352980|NCT02796677|144225556|SUPERIORITY||LS mean difference|0.084|||<|0.0001|TWO_SIDED|95.0|0.051|0.117|||Mixed model for repeated measures|||||0.117|0.051|<0.0001
72352981|NCT02796677|144225557|SUPERIORITY||LS mean difference|0.055||||0.0009|TWO_SIDED|95.0|0.023|0.088|||Mixed model for repeated measures|||||0.088|0.023|0.0009
72352982|NCT02796677|144225558|NON_INFERIORITY|Non-inferiority was established by showing that the lower bound of the two-sided 95% confidence interval for change from baseline in morning pre-dose (trough) FEV1 at week 24 when compared AB 400 μg versus TIO 18 μg was higher than -50 mL (non-inferiority limit).|LS mean difference|0.007||||0.6377|TWO_SIDED|95.0|-0.021|0.035|||Mixed model for repeated measures|||||0.035|-0.021|0.6377
72352983|NCT02796677|144225559|SUPERIORITY||LS mean difference|0.075|||<|0.0001|TWO_SIDED|95.0|0.043|0.107|||Mixed model for repeated measures|||||0.107|0.043|<0.0001
72352984|NCT02796677|144225559|SUPERIORITY||LS mean difference|0.087|||<|0.0001|TWO_SIDED|95.0|0.052|0.122|||Mixed model for repeated measures|||||0.122|0.052|<0.0001
72352985|NCT02796677|144225560|SUPERIORITY||Odds ratio|0.96||||0.8714|TWO_SIDED|95.0|0.61|1.51|||Logistic random-effect model|||||1.51|0.61|0.8714
72352986|NCT02796677|144225560|SUPERIORITY||Odds ratio|0.97||||0.8873|TWO_SIDED|95.0|0.59|1.58|||Logistic random-effect model|||||1.58|0.59|0.8873
72352987|NCT01045967|144225573|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|105.0|||||TWO_SIDED|90.0|90.7|122.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||122|90.7|
72352988|NCT01045967|144225574|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|97.2|||||TWO_SIDED|90.0|86.1|110.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||110|86.1|
72352989|NCT01045967|144225575|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|97.4|||||TWO_SIDED|90.0|86.3|110.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||110|86.3|
72352990|NCT00896298|144225600|SUPERIORITY|||||||0.2572|||||||Mixed Models Analysis|||||||0.2572
72352991|NCT00896298|144225601|SUPERIORITY|||||||0.71|||||||Mixed Models Analysis|||||||0.71
72352992|NCT00896298|144225602|SUPERIORITY|||||||0.68|||||||Mixed Models Analysis|||||||0.68
72352993|NCT00896298|144225603|SUPERIORITY|||||||0.0256|||||||Mixed Models Analysis|||||||0.0256
72352994|NCT01544920|144225604|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower bound of the 95% CI of the difference in SVR24 % exceeded -10%.|Difference in SVR24% in Arm 2 vs. Arm 1|1.7|||||TWO_SIDED|95.0|-3.2|6.5||||||Difference in percentage of participants achieving SVR24||6.5|-3.2|
72352995|NCT01544920|144225605|NON_INFERIORITY_OR_EQUIVALENCE|The observed lower bound of the 95% CI for the difference was 2.5% (which exceeds 0) for BOC added to peg-IFN + RBV in contrast to peg-IFN + RBV alone.|Difference in SVR24%|10.3|||||TWO_SIDED|95.0|2.5|18.1||||||||18.1|2.5|
72352996|NCT00466440|144225606|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|0.2||||1|TWO_SIDED|90.0|-12.52|12.95|||Chi-squared||The objective response rates and the 90% confidence intervals were estimated for the qualified participants using unadjusted normal approximation for binomial proportions (z approximation).|||12.95|-12.52|1.0000
72352997|NCT00466440|144225607|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-11.6||||0.3606|TWO_SIDED|90.0|-28.21|4.95|||Chi-squared|||||4.95|-28.21|0.3606
72352998|NCT00466440|144225608|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.26||||0.072|TWO_SIDED|90.0|-0.02|0.55|||t-test, 1 sided|||||0.55|-0.02|0.0720
72352999|NCT00466440|144225609|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.15||||0.1697|TWO_SIDED|90.0|-0.07|0.37|||t-test, 1 sided|||||0.37|-0.07|0.1697
72353000|NCT00466440|144225610|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.86||||0.524|TWO_SIDED|95.0|0.5|1.4|||Log Rank|||||1.4|0.5|0.5240
72353001|NCT00466440|144225611|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.74||||0.4407|TWO_SIDED|95.0|0.3|1.6|||Log Rank|||||1.6|0.3|0.4407
72353002|NCT00466440|144225612|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.75||||0.3449|TWO_SIDED|95.0|0.4|1.4|||Log Rank|||||1.4|0.4|0.3449
72353003|NCT01217463|144225642|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.44||||0.4109|TWO_SIDED|95.0|0.6|3.43|||Regression, Logistic|||||3.43|0.60|0.4109
72353004|NCT01217463|144225643|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.37|||||TWO_SIDED|95.0|0.78|2.4|||Regression, Logistic|||||2.4|0.78|
72353005|NCT00945282|144225761|SUPERIORITY||Mean Difference (Final Values)|-0.932||||0.042|TWO_SIDED|95.0|-1.812|-0.053|||ANCOVA|||||-0.053|-1.812|0.042
72353006|NCT00945282|144225762|SUPERIORITY||Mean Difference (Final Values)|-0.413||||0.221|TWO_SIDED|95.0|-1.173|0.347|||ANCOVA|||||0.347|-1.173|0.221
72353007|NCT00945282|144225763|SUPERIORITY_OR_OTHER||||||<|0.0001||||||The p-value is the value for GSK2248761 30 mg, at Day 1 to Day 8|Mixed Models Analysis|||Day 1 to Day 8||||<0.0001
72353008|NCT00945282|144225763|SUPERIORITY_OR_OTHER|||||||0.6922||||||The p-value is the value for placebo, at Day 1 to Day 8|Mixed Models Analysis|||Placebo, Day 1 to Day 8||||0.6922
72353009|NCT03101566|144225791|OTHER||||||||||||||||||PFS at 6 months was estimated for this trial using the product-limit method of Kaplan and Meier with 95% confidence intervals calculated using Greenwood's formula. All statistical analyses were completed using the SAS System, v9.4 \[Cary, NC, USA\].|||
72353010|NCT01292187|144225802|SUPERIORITY_OR_OTHER|||||||0.0265|||||||Mixed Models Analysis|||||||0.0265
72353011|NCT01292187|144225803|SUPERIORITY_OR_OTHER|||||||0.034|||||||Mixed Models Analysis|||||||0.0340
72353012|NCT01623115|144225824|SUPERIORITY_OR_OTHER||LS mean difference|-57.9|||<|0.0001|TWO_SIDED|95.0|-63.3|-52.6||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs Placebo|Alirocumab group was compared to placebo group using an appropriate contrast statement.||-52.6|-63.3|<0.0001
72353013|NCT01623115|144225825|SUPERIORITY_OR_OTHER||LS mean difference|-58.1|||<|0.0001|TWO_SIDED|95.0|-63.5|-52.7||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs Placebo|A hierarchical testing procedure was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when previous endpoint was statistically significant at 0.05 level.||-52.7|-63.5|<0.0001
72353014|NCT01623115|144225826|SUPERIORITY_OR_OTHER||LS mean difference|-49.2|||<|0.0001|TWO_SIDED|95.0|-53.9|-44.5||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-44.5|-53.9|<0.0001
72369517|NCT00740857|144249262|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA|With treatment, baseline Pain Severity Rating (PSR), and gender terms.||The 30, 45, 60, 90, 120, 180, 240, 300 and 360 minute individual time points all have the same P-value score.||||<0.001
72353015|NCT01623115|144225827|SUPERIORITY_OR_OTHER||LS mean difference|-49.5|||<|0.0001|TWO_SIDED|95.0|-54.2|-44.8||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant)||-44.8|-54.2|<0.0001
72353016|NCT01623115|144225828|SUPERIORITY_OR_OTHER||LS mean difference|-45.8|||<|0.0001|TWO_SIDED|95.0|-49.8|-41.8||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-41.8|-49.8|<0.0001
72353017|NCT01623115|144225829|SUPERIORITY_OR_OTHER||LS mean difference|-45.9|||<|0.0001|TWO_SIDED|95.0|-49.9|-41.8||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-41.8|-49.9|<0.0001
72353018|NCT01623115|144225830|SUPERIORITY_OR_OTHER||LS mean difference|-52.4|||<|0.0001|TWO_SIDED|95.0|-57.2|-47.6||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-47.6|-57.2|<0.0001
72353019|NCT01623115|144225831|SUPERIORITY_OR_OTHER||LS mean difference|-52.6|||<|0.0001|TWO_SIDED|95.0|-57.5|-47.8||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-47.8|-57.5|<0.0001
72353020|NCT01623115|144225832|SUPERIORITY_OR_OTHER||LS mean difference|-38.7|||<|0.0001|TWO_SIDED|95.0|-42.4|-35.0||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-35|-42.4|<0.0001
72353021|NCT01623115|144225833|SUPERIORITY_OR_OTHER||LS mean difference|-37.5|||<|0.0001|TWO_SIDED|95.0|-41.2|-33.9||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-33.9|-41.2|<0.0001
72353022|NCT01623115|144225834|SUPERIORITY_OR_OTHER||LS Mean Difference|-43.7|||<|0.0001|TWO_SIDED|95.0|-48.0|-39.4||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-39.4|-48|<0.0001
72353023|NCT01623115|144225835|SUPERIORITY_OR_OTHER||LS mean difference|-32.5|||<|0.0001|TWO_SIDED|95.0|-35.7|-29.2||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-29.2|-35.7|<0.0001
72353024|NCT01623115|144225836|SUPERIORITY_OR_OTHER||LS mean difference|-56.2|||<|0.0001|TWO_SIDED|95.0|-62.4|-50.0||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-50|-62.4|<0.0001
72353025|NCT01623115|144225837|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|156.0|||<|0.0001|TWO_SIDED|95.0|48.9|498.1||Threshold for significance ≤ 0.05.|Regression, Logistic|Multiple imputation approach followed by logistic regression model|Alirocumab vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||498.1|48.9|<0.0001
72353026|NCT01623115|144225838|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|156.6|||<|0.0001|TWO_SIDED|95.0|49.7|493.7||Threshold for significance ≤ 0.05.|Regression, Logistic|Multiple imputation approach followed by logistic regression model.|Alirocumab vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||493.7|49.7|<0.0001
72353027|NCT01623115|144225839|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|244.9|||<|0.0001|TWO_SIDED|95.0|34.4|1744.4||Threshold for significance ≤ 0.05.|Regression, Logistic|Multiple imputation approach followed by logistic regression model.|Alirocumab vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||1744.4|34.4|<0.0001
72353028|NCT01623115|144225840|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|240.0|||<|0.0001|TWO_SIDED|95.0|33.9|1700.7||Threshold for significance ≤ 0.05.|Regression, Logistic|Multiple imputation approach followed by logistic regression model.|Alirocumab vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||1700.7|33.9|<0.0001
72353029|NCT01623115|144225841|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-17.7|||<|0.0001|TWO_SIDED|95.0|-22.6|-12.9||Threshold for significance ≤ 0.05.|Regression, Robust|Multiple imputation approach followed by robust regression model.|Alirocumab vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-12.9|-22.6|<0.0001
72353030|NCT01623115|144225842|SUPERIORITY_OR_OTHER||LS mean difference|8.0|||<|0.0001|TWO_SIDED|95.0|5.0|11.0||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||11|5|<0.0001
72353031|NCT01623115|144225843|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-16.0|||<|0.0001|TWO_SIDED|95.0|-21.3|-10.6||Threshold for significance was ≤ 0.05.|Regression, Robust|Multiple imputation approach followed by robust regression model.|Alirocumab vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-10.6|-21.3|<0.0001
72353032|NCT01623115|144225844|SUPERIORITY_OR_OTHER||LS mean difference|4.7|||=|0.0002|TWO_SIDED|95.0|2.3|7.2||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||7.2|2.3|= 0.0002
72353033|NCT01623115|144225845|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-17.3|||<|0.0001|TWO_SIDED|95.0|-21.5|-13.0||Threshold for significance ≤ 0.05.|Regression, Robust|Multiple imputation approach followed by robust regression model.|Alirocumab vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-13|-21.5|<0.0001
72353034|NCT01623115|144225846|SUPERIORITY_OR_OTHER||LS mean difference|4.3||||0.0031|TWO_SIDED|95.0|1.5|7.2||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||7.2|1.5|0.0031
72353035|NCT01623115|144225847|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-9.7||||0.0003|TWO_SIDED|95.0|-15.0|-4.4||Threshold for significance ≤ 0.05.|Regression, Robust|Multiple imputation approach followed by robust regression model.|Alirocumab vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-4.4|-15|0.0003
72353036|NCT01623115|144225848|SUPERIORITY_OR_OTHER||LS mean difference|2.8||||0.0187|TWO_SIDED|95.0|0.5|5.2||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||5.2|0.5|0.0187
72353037|NCT02119871|144225854|SUPERIORITY||Median Difference (Final Values)|14.0||||1|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||1.00
72353038|NCT02119871|144225855|SUPERIORITY||Median Difference (Final Values)|10.0||||0.656|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.656
72353039|NCT02119871|144225856|SUPERIORITY||Median Difference (Final Values)|4.0||||1|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||1
72353040|NCT00287716|144225866|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.64||||0.023|TWO_SIDED|95.0|0.44|0.95|||Log Rank|||The null hypothesis is that there is no treatment difference between the pirfenidone 2403 mg/day treatment group and the placebo treatment group.||0.95|0.44|0.023
72353041|NCT00287716|144225872|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.84||||0.515|TWO_SIDED|95.0|0.5|1.42|||Log Rank|||The null hypothesis is that there is no treatment difference between the pirfenidone 2403-mg/d treatment group and the placebo treatment group.||1.42|0.50|0.515
72353042|NCT01236521|144225887|SUPERIORITY||Mean Difference (Net)|0.39|STANDARD_DEVIATION|0.13||0.0385|TWO_SIDED||||||Mixed Models Analysis|||||||0.0385
72353043|NCT01236521|144225888|SUPERIORITY||Mean Difference (Net)|0.44|STANDARD_DEVIATION|0.11||0.0067|TWO_SIDED||||||Mixed Models Analysis|||||||0.0067
72353044|NCT01236521|144225889|SUPERIORITY||Median Difference (Net)|0.39|STANDARD_DEVIATION|0.15||0.074|TWO_SIDED||||||Mixed Models Analysis|||||||0.0740
72353045|NCT04491136|144225908|OTHER||||||>|0.9999|||||||McNemar|||At least one SVT occurred||||>0.9999
72353046|NCT04491136|144225908|OTHER|||||||0.7905|||||||McNemar|||At least one NSVT occurred||||0.7905
72353047|NCT04491136|144225908|OTHER|||||||0.625|||||||McNemar|||At least one PVC occurred||||0.6250
72353048|NCT04491136|144225910|OTHER||Mean Difference (Final Values)|2.41|STANDARD_ERROR_OF_MEAN|0.653||0.0008|TWO_SIDED|95.0|1.11|3.7|||Wilcoxon signed-rank|||||3.70|1.11|0.0008
72353049|NCT04491136|144225911|OTHER||Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.028||0.5733|TWO_SIDED|95.0|-0.07|0.04|||Ridit analysis|||||0.04|-0.07|0.5733
72353050|NCT04491136|144225912|OTHER||Mean Difference (Final Values)|-231.46|STANDARD_ERROR_OF_MEAN|93.03||0.0006|TWO_SIDED|95.0|-415.9|-47.02|||Wilcoxon signed rank test|||||-47.02|-415.90|0.0006
72353051|NCT04491136|144225914|OTHER||||||>|0.9999|||||||McNemar|||Occurrence of at least one shock||||>0.9999
72353052|NCT04491136|144225914|OTHER|||||||0.0654|||||||McNemar|||Occurrence of at least one ATP event||||0.0654
72353053|NCT02756572|144225949|OTHER|||||||0.18|||||||Wilcoxon (Mann-Whitney)|||||||0.18
72353054|NCT02756572|144225950|OTHER|||||||0.18|||||||Wilcoxon (Mann-Whitney)|||||||0.18
72353055|NCT02756572|144225951|OTHER|||||||0.049|||||||Fisher Exact|||||||0.049
72353056|NCT02756572|144225952|OTHER|||||||0.77|||||||Wilcoxon (Mann-Whitney)|||||||0.77
72353057|NCT05736874|144226087|SUPERIORITY|Decision rule based on Bayesian posterior probability of efficacy. The decision threshold was a posterior probability of 0.95. A prespecified skeptical prior for the treatment effect was used to preserve type I error below 0.05.|Hazard Ratio (HR)|1.01|||||TWO_SIDED|95.0|0.91|1.12|||||The interval is a highest-density credible interval. Adjustment variables: randomization, age, sex, duration of symptoms prior to study drug, calendar time, vaccination status, geographic region, call center indicator, and baseline symptom severity.|||1.12|0.91|
72353058|NCT05736874|144226088|SUPERIORITY||Hazard Ratio (HR)|0.94|||||TWO_SIDED|95.0|0.19|4.68|||||Descriptive analysis is a maximum partial likelihood proportional hazards regression model. Low event rate precluded covariate adjustment.|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.||4.68|0.19|
72353059|NCT05736874|144226091|SUPERIORITY|Statistical analysis was a Bayesian proportional hazards regression model with covariate adjustment and weakly informative priors.|Hazard Ratio (HR)|1.9|||||TWO_SIDED|95.0|0.8|3.5|||||The interval is a highest-density credible interval. Adjustment variables: randomization, age, sex, duration of symptoms prior to study drug, calendar time, vaccination status, geographic region, call center indicator, and baseline symptom severity.|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.||3.5|0.8|
72353060|NCT05736874|144226092|SUPERIORITY|Statistical analysis was a Bayesian cumulative probability ordinal regression model with covariate adjustment and weakly informative priors.|Odds Ratio (OR)|1.1|||||TWO_SIDED|95.0|0.62|1.63|||||The interval is a highest-density credible interval on the log relative odds scale. Odds ratio estimate from a Bayesian cumulative probability ordinal regression model with weakly informative priors.|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.||1.63|0.62|
72353061|NCT05736874|144226093|SUPERIORITY|Statistical analysis was a Bayesian cumulative probability ordinal regression model with covariate adjustment and weakly informative priors.|Odds Ratio (OR)|0.91|||||TWO_SIDED|95.0|0.42|1.5|||||The interval is a highest-density credible interval on the log relative odds scale. Odds ratio estimate from a Bayesian cumulative probability ordinal regression model with weakly informative priors.|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.||1.50|0.42|
72369518|NCT00740857|144249263|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA|With treatment, baseline Pain Severity Rating (PSR), and gender terms.||||||<0.001
72369519|NCT00740857|144249264|SUPERIORITY_OR_OTHER|||||||0.056|||||||ANOVA|Adjusted with treatment, baseline Pain Severity Rating (PSR), and gender terms.||15 minutes||||0.056
72369520|NCT00740857|144249264|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA|Adjusted with treatment, baseline Pain Severity Rating (PSR), and gender terms.||The 30, 45, 60, 90, 120, 180, 240, 300 and 360 minute individual time points all have the same P-value score.||||<0.001
72369521|NCT00740857|144249265|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA|Adjusted with treatment, baseline Pain Severity Rating (PSR), and gender terms.||||||<0.001
72369522|NCT00740857|144249266|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA|Adjusted with treatment, baseline Pain Severity Rating (PSR), and gender terms.||||||<0.001
72353062|NCT05736874|144226094|SUPERIORITY|Statistical analysis was a Bayesian cumulative probability ordinal regression model with covariate adjustment and weakly informative priors|Odds Ratio (OR)|2.74|||||TWO_SIDED|95.0|0.5|5.94|||||The interval is a highest-density credible interval on the log relative odds scale. Odds ratio estimate from a Bayesian cumulative probability ordinal regression model with weakly informative priors.|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.||5.94|0.50|
72353063|NCT05736874|144226095|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|0.87|||||TWO_SIDED|95.0|0.69|1.11|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 7||1.11|0.69|
72353064|NCT05736874|144226095|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|1.02|||||TWO_SIDED|95.0|0.78|1.34|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 14||1.34|0.78|
72353065|NCT05736874|144226095|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|1.06|||||TWO_SIDED|95.0|0.78|1.45|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 28||1.45|0.78|
72353066|NCT05736874|144226095|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|1.1|||||TWO_SIDED|95.0|0.79|1.53|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 90||1.53|0.79|
72353067|NCT05736874|144226096|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|0.89|||||TWO_SIDED|95.0|0.72|1.09|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 7||1.09|0.72|
72353068|NCT05736874|144226096|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|1.03|||||TWO_SIDED|95.0|0.84|1.27|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 14||1.27|0.84|
72353069|NCT05736874|144226096|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|0.95|||||TWO_SIDED|95.0|0.76|1.2|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 28||1.20|0.76|
72353070|NCT05736874|144226096|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|1.05|||||TWO_SIDED|95.0|0.84|1.32|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 90||1.32|0.84|
72353071|NCT05736874|144226097|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|0.74|||||TWO_SIDED|95.0|0.58|0.93|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 7||0.93|0.58|
72353072|NCT05736874|144226097|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|1.0|||||TWO_SIDED|95.0|0.76|1.32|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 14||1.32|0.76|
72353073|NCT05736874|144226097|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|0.94|||||TWO_SIDED|95.0|0.71|1.25|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 28||1.25|0.71|
72353074|NCT05736874|144226097|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|1.21|||||TWO_SIDED|95.0|0.89|1.64|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 90||1.64|0.89|
72353075|NCT05736874|144226098|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|0.9|||||TWO_SIDED|95.0|0.7|1.15|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 7||1.15|0.70|
72353076|NCT05736874|144226098|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|0.98|||||TWO_SIDED|95.0|0.75|1.29|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 14||1.29|0.75|
72353077|NCT05736874|144226098|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|0.95|||||TWO_SIDED|95.0|0.72|1.26|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 28||1.26|0.72|
72353078|NCT05736874|144226098|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|1.22|||||TWO_SIDED|95.0|0.92|1.61|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 90||1.61|0.92|
72353079|NCT05736874|144226099|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|1.02|||||TWO_SIDED|95.0|0.81|1.28|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 7||1.28|0.81|
72353080|NCT05736874|144226099|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|0.77|||||TWO_SIDED|95.0|0.6|0.99|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 14||0.99|0.60|
72353081|NCT05736874|144226099|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|0.95|||||TWO_SIDED|95.0|0.74|1.23|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 28||1.23|0.74|
72353082|NCT05736874|144226099|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|1.15|||||TWO_SIDED|95.0|0.89|1.5|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 90||1.50|0.89|
72353083|NCT05736874|144226100|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|0.85|||||TWO_SIDED|95.0|0.69|1.06|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 7||1.06|0.69|
72353084|NCT05736874|144226100|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|1.03|||||TWO_SIDED|95.0|0.82|1.3|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 14||1.30|0.82|
72353085|NCT05736874|144226100|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|1.03|||||TWO_SIDED|95.0|0.8|1.32|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 28||1.32|0.80|
72353086|NCT05736874|144226100|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|0.99|||||TWO_SIDED|95.0|0.75|1.29|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 90||1.29|0.75|
72353087|NCT05736874|144226101|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|0.76|||||TWO_SIDED|95.0|0.62|0.93|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 7||0.93|0.62|
72353088|NCT05736874|144226101|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|0.96|||||TWO_SIDED|95.0|0.78|1.18|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 14||1.18|0.78|
72353089|NCT05736874|144226101|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|0.91|||||TWO_SIDED|95.0|0.74|1.12|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 28||1.12|0.74|
72353090|NCT05736874|144226101|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|1.26|||||TWO_SIDED|95.0|1.02|1.56|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 90||1.56|1.02|
72353091|NCT05736874|144226102|SUPERIORITY||Difference in model estimate time unwell|-0.1|||||TWO_SIDED|95.0|-0.45|0.26|||||The interval is a highest-density credible interval.|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.||0.26|-0.45|
72353092|NCT05736874|144226103|SUPERIORITY||Difference in model estimated means|0.13|||||TWO_SIDED|95.0|-0.28|0.58|||||The interval is a highest-density credible interval.|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.||0.58|-0.28|
72353093|NCT03057496|144226124|SUPERIORITY||Rate ratio|0.627|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|0.536|0.734||Since the outcome (contacts) represented over-dispersed count data and there were repeated measurements per subject, a generalized mixed effects model with a negative binomial family was used with each subject treated as a random intercept.|Mixed Models Analysis|Fixed factors were included in the model to account for factors other than device operating mode that might affect collision rates.|Silent mode is the denominator for the rate ratio.|A within-subject comparison was performed. Each subject included in the analysis used the device in both the active and the silent mode. Comparison was between the two device operating modes. The null hypothesis was that there was no difference in the rate of contacts between active and silent modes.||0.734|0.536|< 0.001
72353094|NCT03270943|144226128|SUPERIORITY|||||||0.02|||||||Log Rank|||||||0.02
72353095|NCT03270943|144226129|OTHER|within group|Mean Difference (Net)|-1.01|STANDARD_ERROR_OF_MEAN|0.21|||TWO_SIDED|95.0|-6.06|3.84|||||Difference between score at 8 weeks and score at baseline.|||3.84|-6.06|
72353096|NCT03270943|144226129|OTHER|within group|Mean Difference (Net)|-4.46|STANDARD_ERROR_OF_MEAN|2.05|||TWO_SIDED|95.0|-8.7|-0.22|||||Difference between score at 8 weeks and score at baseline.|||-0.22|-8.70|
72353097|NCT03270943|144226130|OTHER|within group change|Mean Difference (Net)|-0.64|STANDARD_ERROR_OF_MEAN|0.99|||TWO_SIDED|95.0|-2.72|0.2|||||Difference between score at 8 weeks and score at baseline.|||0.2|-2.72|
72353098|NCT03270943|144226130|OTHER|within group change|Mean Difference (Net)|-1.72|STANDARD_ERROR_OF_MEAN|0.91|||TWO_SIDED|95.0|-3.6|0.16|||||Difference between score at 8 weeks and score at baseline.|||0.16|-3.60|
72353099|NCT03270943|144226131|OTHER|Within group change|Mean Difference (Net)|0.23|||||TWO_SIDED|95.0|-0.15|0.61|||||Difference between score at 8 weeks and score at baseline.|||0.61|-0.15|
72353100|NCT03270943|144226131|OTHER|within group change|Mean Difference (Net)|0.35|STANDARD_ERROR_OF_MEAN|0.13|||TWO_SIDED|95.0|0.07|0.63|||||Difference between score at 8 weeks and score at baseline.|||0.63|0.07|
72353101|NCT02981368|144226145|SUPERIORITY|||||||0.1097|||||||Fisher Exact|||Tissue Site: Bone||||0.1097
72353102|NCT02981368|144226145|SUPERIORITY|||||||0.1087|||||||Fisher Exact|||Tissue Site: Bone||||0.1087
72353103|NCT02981368|144226145|SUPERIORITY|||||||0.1949|||||||Fisher Exact|||Tissue Site: Bone||||0.1949
72353104|NCT02981368|144226145|SUPERIORITY|||||||0.1315|||||||Fisher Exact|||Tissue Site: Bone||||0.1315
72353105|NCT02981368|144226145|SUPERIORITY|||||||0.1977|||||||Fisher Exact|||Tissue Site: Bone||||0.1977
72353106|NCT02981368|144226145|SUPERIORITY|||||||0.2149|||||||Fisher Exact|||Tissue Site: Bone||||0.2149
72353107|NCT02981368|144226145|SUPERIORITY|||||||0.2582|||||||Fisher Exact|||Tissue Site: Visceral/Soft tissue||||0.2582
72353108|NCT02981368|144226145|SUPERIORITY|||||||0.0009|||||||Fisher Exact|||Tissue Site: Visceral/Soft tissue||||0.0009
72353109|NCT02981368|144226145|SUPERIORITY|||||||0.3588|||||||Fisher Exact|||Tissue Site: Visceral/Soft tissue||||0.3588
72353110|NCT02981368|144226145|SUPERIORITY|||||||0.8791|||||||Fisher Exact|||Tissue Site: Visceral/Soft tissue||||0.8791
72353111|NCT02981368|144226145|SUPERIORITY|||||||0.9457|||||||Fisher Exact|||Tissue Site: Visceral/Soft tissue||||0.9457
72353112|NCT02981368|144226145|SUPERIORITY|||||||0.2705|||||||Fisher Exact|||Tissue Site: Visceral/Soft tissue||||0.2705
72353113|NCT02981368|144226145|SUPERIORITY||||||<|0.0001|||||||Chi-squared|||Tissue Type: Lymph nodes||||<0.0001
72353114|NCT02981368|144226145|SUPERIORITY||||||<|0.0001|||||||Chi-squared|||Tissue Type: Lymph nodes||||<0.0001
72353115|NCT02981368|144226145|SUPERIORITY||||||<|0.0001|||||||Chi-squared|||Tissue Type: Lymph nodes||||<0.0001
72353116|NCT02981368|144226145|SUPERIORITY|||||||0.5933|||||||Chi-squared|||Tissue Type: Lymph nodes||||0.5933
72353117|NCT02981368|144226145|SUPERIORITY|||||||0.7094|||||||Chi-squared|||Tissue Type: Lymph nodes||||0.7094
72353118|NCT02981368|144226145|SUPERIORITY|||||||0.5424|||||||Chi-squared|||Tissue Type: Lymph nodes||||0.5424
72353119|NCT02981368|144226145|SUPERIORITY||||||<|0.0001|||||||Chi-squared|||Tissue Site: Prostate Gland||||<0.0001
72353120|NCT02981368|144226145|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||Tissue Site: Prostate Gland||||<0.0001
72353121|NCT02981368|144226145|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||Tissue Site: Prostate Gland||||<0.0001
72353122|NCT02981368|144226145|SUPERIORITY|||||||0.0038|||||||Fisher Exact|||Tissue Site: Prostate Gland||||0.0038
72353123|NCT02981368|144226145|SUPERIORITY|||||||0.0647|||||||Fisher Exact|||Tissue Site: Prostate Gland||||0.0647
72353124|NCT02981368|144226145|SUPERIORITY|||||||0.0021|||||||Chi-squared|||Tissue Site: Prostate Gland||||0.0021
72353125|NCT02981368|144226145|SUPERIORITY||||||<|0.0001|||||||Chi-squared|||Tissue Site: All||||<0.0001
72353126|NCT02981368|144226145|SUPERIORITY||||||<|0.0001|||||||Chi-squared|||Tissue Site: All||||<0.0001
72353127|NCT02981368|144226145|SUPERIORITY||||||<|0.0001|||||||Chi-squared|||Tissue Site: All||||<0.0001
72353128|NCT02981368|144226145|SUPERIORITY|||||||0.0815|||||||Chi-squared|||Tissue Site: All||||0.0815
72353129|NCT02981368|144226145|SUPERIORITY|||||||0.7507|||||||Chi-squared|||Tissue Site: All||||0.7507
72353130|NCT02981368|144226145|SUPERIORITY|||||||0.562|||||||Chi-squared|||Tissue Site: All||||0.5620
72353131|NCT01584232|144226177|NON_INFERIORITY_OR_EQUIVALENCE|If the upper limit of the 95% Confidence Interval (CI) was \<0.4%, then LY2189265 was declared non-inferior to insulin glargine. If the upper limit of the 95% CI was \<0.0%, then LY2189265 was declared superior to insulin glargine.|LS Mean Difference|-0.54|||<|0.001|TWO_SIDED|95.0|-0.67|-0.41||P-value is from the pairwise comparison of LS means using a mixed effects model with repeated measurements (MMRM).|Mixed Models Analysis|||Approximately 360 participants were to be randomized in a 1:1 ratio to LY2189265 or insulin glargine (IG). Assuming no difference in HbA1c change from baseline at Week 26 between LY2189265 and IG, this sample size would provide approximately 90% power to confirm non-inferiority of LY2189265 to IG. This computation was based on a non-inferiority margin of 0.4% with a standard deviation of 1.1%, a 1-sided alpha level of 0.025, and an 11% dropout rate between randomization and Week 26.||-0.41|-0.67|<0.001
72353132|NCT01584232|144226178|SUPERIORITY_OR_OTHER||||||<|0.001||||||Treatment comparison for HbA1c \<=6.5%.|Regression, Logistic|||||||<0.001
72353133|NCT01584232|144226178|SUPERIORITY_OR_OTHER||||||<|0.001||||||Treatment comparison for HbA1c \<7%.|Regression, Logistic|||||||<0.001
72353134|NCT01584232|144226179|SUPERIORITY_OR_OTHER||LS Mean Difference|3.5||||0.183|TWO_SIDED|95.0|-1.7|8.7|||Mixed Models Analysis|||||8.7|-1.7|0.183
72353135|NCT01584232|144226180|SUPERIORITY_OR_OTHER||LS Mean Difference|5.16||||0.022|TWO_SIDED|95.0|0.76|9.56||Treatment comparison for pre-morning meal.|ANCOVA|||||9.56|0.76|0.022
72353136|NCT01584232|144226180|SUPERIORITY_OR_OTHER||LS Mean Difference|-13.4||||0.003|TWO_SIDED|95.0|-22.28|-4.52||Treatment comparison for 2 hours post-morning meal.|ANCOVA|||||-4.52|-22.28|0.003
72353137|NCT01584232|144226180|SUPERIORITY_OR_OTHER||LS Mean Difference|-8.22||||0.025|TWO_SIDED|95.0|-15.37|-1.06||Treatment comparison for pre-midday meal.|ANCOVA|||||-1.06|-15.37|0.025
72353138|NCT01584232|144226180|SUPERIORITY_OR_OTHER||LS Mean Difference|-23.22|||<|0.001|TWO_SIDED|95.0|-31.92|-14.51||Treatment comparison for 2 hours post-midday meal.|ANCOVA|||||-14.51|-31.92|<0.001
72353139|NCT01584232|144226180|SUPERIORITY_OR_OTHER||LS Mean Difference|-13.63|||<|0.001|TWO_SIDED|95.0|-21.03|-6.24||Treatment comparison for pre-evening meal.|ANCOVA|||||-6.24|-21.03|<0.001
72353140|NCT01584232|144226180|SUPERIORITY_OR_OTHER||LS Mean Difference|-31.13|||<|0.001|TWO_SIDED|95.0|-39.26|-23.0||Treatment comparison for 2 hours post-evening meal.|ANCOVA|||||-23.00|-39.26|<0.001
72353141|NCT01584232|144226180|SUPERIORITY_OR_OTHER||LS Mean Difference|-23.73|||<|0.001|TWO_SIDED|95.0|-31.68|-15.79||Treatment comparison for bedtime.|ANCOVA|||||-15.79|-31.68|<0.001
72353142|NCT01584232|144226180|SUPERIORITY_OR_OTHER||LS Mean Difference|6.21||||0.005|TWO_SIDED|95.0|1.92|10.5||Treatment comparison for second pre-morning meal.|ANCOVA|||||10.50|1.92|0.005
72353143|NCT01584232|144226181|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.42|||<|0.001|TWO_SIDED|95.0|-1.89|-0.94|||Mixed Models Analysis|||||-0.94|-1.89|<0.001
72353144|NCT01584232|144226182|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Fisher Exact|||||||<0.001
72353145|NCT00790192|144226215|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0|||||Mixed Models Analysis|||||||<0.05
72353146|NCT00790192|144226216|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0|||||Mixed Models Analysis|||||||<0.05
72353147|NCT00411749|144226252|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.001
72353148|NCT00411749|144226253|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.001
72353149|NCT00411749|144226254|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.001
72353150|NCT00411749|144226255|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.001
72353151|NCT00411749|144226256|SUPERIORITY_OR_OTHER||Geometric Mean|155.2|||||TWO_SIDED|95.0|126.2|190.9||||||||190.9|126.2|
72353152|NCT00411749|144226256|SUPERIORITY_OR_OTHER||Geometric Mean|198.2|||||TWO_SIDED|95.0|160.9|244.2||||||||244.2|160.9|
72353153|NCT00411749|144226256|SUPERIORITY_OR_OTHER||Geometric Mean|617.1|||||TWO_SIDED|95.0|491.7|774.5||||||||774.5|491.7|
72353154|NCT00411749|144226256|SUPERIORITY_OR_OTHER||Geometric Mean|90.0|||||TWO_SIDED|95.0|68.8|117.8||||||||117.8|68.8|
72353155|NCT00964496|144226261|SUPERIORITY_OR_OTHER||Differences in proportions|0.677||||1.3e-07|TWO_SIDED|95.0|0.547|0.807||P\<0.05 was considered as statistical different, while P\>0.05 was considered as no statistical significance between two groups. All reported P values are two-sided.|Fisher Exact|||"Null hypothesis (H0): Thalidomide 100 mg per day is equivalence to iron 400 mg per day with regard to the participants whose rebleeds decreased from baseline by ≥ 50% at 12 months.~Alternative hypothesis (Ha): Thalidomide 100 mg per day is non-equivalent to iron 400 mg per day with regard to the participants whose rebleeds decreased from baseline by ≥ 50% at 12 months.~Comparisons were performed with the use of the chi-square test, Fisher's exact test."||0.807|0.547|0.00000013
72353156|NCT00964496|144226262|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.08|||<|0.001|TWO_SIDED|95.0|-4.02|-2.13||P\<0.05 was considered as statistical different, while P\>0.05 was considered as no statistical significance between two groups. All reported P values are two-sided.|t-test, 2 sided|||"Null hypothesis (H0): Thalidomide 100 mg per day is equivalence to iron 400 mg per day with regard to the change from baseline in hemoglobin level at 12 months.~Alternative hypothesis (Ha): Thalidomide 100 mg per day is non-equivalent to iron 400 mg per day with regard to the change from baseline in hemoglobin level at 12 months.~Comparisons were performed with the use of the independent-samples t test."||-2.13|-4.02|<0.001
72353157|NCT00964496|144226263|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.95|||<|0.01|TWO_SIDED|95.0|6.0|9.9||P\<0.05 was considered as statistical different, while P\>0.05 was considered as no statistical significance between two groups. All reported P values are two-sided.|t-test, 2 sided|||"Null hypothesis (H0): Thalidomide 100 mg per day is equivalence to iron 400 mg per day with regard to the change from baseline in bleeding episodes at 12 months.~Alternative hypothesis (Ha): Thalidomide 100 mg per day is non-equivalent to iron 400 mg per day with regard to the change from baseline in bleeding episodes at 12 months.~Comparisons were performed with the use of the independent-samples t test."||9.90|6.00|<0.01
72353158|NCT00964496|144226264|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.4||||0.0002474|TWO_SIDED|95.0|2.15|6.64||P\<0.05 was considered as statistical different, while P\>0.05 was considered as no statistical significance between two groups. All reported P values are two-sided.|t-test, 2 sided|||"Null hypothesis (H0): Thalidomide 100 mg per day is equivalence to iron 400 mg per day with regard to the change from baseline in bleeding duration at 12 months.~Alternative hypothesis (Ha): Thalidomide 100 mg per day is non-equivalent to iron 400 mg per day with regard to the change from baseline in bleeding duration at 12 months.~Comparisons were performed with the use of the independent-samples t test."||6.64|2.15|0.00024740
72353159|NCT00964496|144226265|SUPERIORITY_OR_OTHER||Differences in proportions|-0.374||||0.00298881|TWO_SIDED|95.0|-0.563|-0.185||P\<0.05 was considered as statistical different, while P\>0.05 was considered as no statistical significance between two groups. All reported P values are two-sided.|Fisher Exact|||"Null hypothesis (H0): Thalidomide 100 mg per day is equivalence to iron 400 mg per day with regard to the participants dependent on blood transfusions.~Alternative hypothesis (Ha): Thalidomide 100 mg per day is non-equivalent to iron 400 mg per day with regard to the participants dependent on blood transfusions.~Comparisons were performed with the use of the chi-square test, Fisher's exact test."||-0.185|-0.563|0.00298881
72353160|NCT00964496|144226266|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1557.14|||<|0.01|TWO_SIDED|95.0|1294.53|1819.76||P\<0.05 was considered as statistical different, while P\>0.05 was considered as no statistical significance between two groups. All reported P values are two-sided.|t-test, 2 sided|||"Null hypothesis (H0): Thalidomide 100 mg per day is equivalence to iron 400 mg per day with regard to the change from baseline in total transfused red cell requirements at 12 months.~Alternative hypothesis (Ha): Thalidomide 100 mg per day is non-equivalent to iron 400 mg per day with regard to the change from baseline in total transfused red cell requirements at 12 months.~Comparisons were performed with the use of the independent-samples t test."||1819.76|1294.53|<0.01
72353161|NCT00964496|144226267|SUPERIORITY_OR_OTHER||Differences in proportions|0.464||||3.962e-05|TWO_SIDED|95.0|0.28|0.649|||Fisher Exact|||"Null hypothesis (H0): Thalidomide 100 mg per day is equivalence to iron 400 mg per day with regard to the cessation of bleeding.~Alternative hypothesis (Ha): Thalidomide 100 mg per day is non-equivalent to iron 400 mg per day with regard to the cessation of bleeding.~Comparisons were performed with the use of the chi-square test, Fisher's exact test."||0.649|0.28|0.00003962
72353162|NCT01147666|144226312|OTHER|||||||1||||||Threshold for significance at 0.05 level.|Fisher Exact|||||||1.0000
72353163|NCT01147666|144226312|OTHER|||||||0.0698||||||Threshold for significance at 0.05 level.|Fisher Exact|||||||0.0698
72353164|NCT01147666|144226312|OTHER|||||||0.1534||||||Threshold for significance at 0.05 level.|Fisher Exact|||||||0.1534
72353165|NCT01147666|144226312|OTHER|||||||0.2657||||||Threshold for significance at 0.05 level.|Fisher Exact|||||||0.2657
72353166|NCT01147666|144226313|OTHER|||||||1||||||Threshold for significance at 0.05 level.|Fisher Exact|||||||1.0000
72353167|NCT01135134|144226344|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
72353168|NCT01135134|144226345|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
72353169|NCT00255190|144226351|SUPERIORITY_OR_OTHER|||||||0.042||95.0||||Statistical significance was determined at 0.05 level. All statistical tests were two-sided and the p-values were rounded to 3 decimal places prior to determining statistical significance.|ANOVA|||||||0.042
72353170|NCT00255190|144226352|SUPERIORITY_OR_OTHER|||||||0.006||95.0||||Statistical significance was determined at 0.05 level. All statistical tests were two-sided and the p-values were rounded to 3 decimal places prior to determining statistical significance.|ANOVA|||||||0.006
72353171|NCT00255190|144226353|SUPERIORITY_OR_OTHER|||||||0.204||95.0||||Statistical significance was determined at 0.05 level. All statistical tests were two-sided and the p-values were rounded to 3 decimal places prior to determining statistical significance.|ANCOVA|Comparisons were made using a one-way analysis of covariance (ANCOVA) model with treatment as the factor and baseline score as the covariate.||||||0.204
72353172|NCT00255190|144226354|SUPERIORITY_OR_OTHER|||||||0.109||95.0||||Statistical significance was determined at 0.05 level. All statistical tests were two-sided and the p-values were rounded to 3 decimal places prior to determining statistical significance.|ANCOVA|Comparisons were made using an ANCOVA model with treatment as the factor and baseline score as the covariate.||||||0.109
72353173|NCT00255190|144226355|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical significance was determined at 0.05 level. All statistical tests were two-sided and the p-values were rounded to 3 decimal places prior to determining statistical significance.|ANOVA|||||||<0.001
72353174|NCT00255190|144226356|SUPERIORITY_OR_OTHER|||||||0.494||95.0||||Statistical significance was determined at 0.05 level. All statistical tests were two-sided and the p-values were rounded to 3 decimal places prior to determining statistical significance.|ANOVA|||||||0.494
72353175|NCT00255190|144226357|SUPERIORITY_OR_OTHER|||||||0.026||95.0||||Statistical significance was determined at 0.05 level. All statistical tests were two-sided and the p-values were rounded to 3 decimal places prior to determining statistical significance.|ANOVA|||||||0.026
72353176|NCT00255190|144226358|SUPERIORITY_OR_OTHER|||||||0.22||95.0||||Statistical significance was determined at 0.05 level. All statistical tests were two-sided and the p-values were rounded to 3 decimal places prior to determining statistical significance.|ANOVA|||||||0.220
72353177|NCT00255190|144226359|SUPERIORITY_OR_OTHER|||||||0.843||95.0||||Statistical significance was determined at 0.05 level. All statistical tests were two-sided and the p-values were rounded to 3 decimal places prior to determining statistical significance.|ANOVA|||||||0.843
72353178|NCT00255190|144226360|SUPERIORITY_OR_OTHER|||||||0.923||95.0||||Statistical significance was determined at 0.05 level. All statistical tests were two-sided and the p-values were rounded to 3 decimal places prior to determining statistical significance.|ANOVA|||||||0.923
72353179|NCT00255190|144226361|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical significance was determined at 0.05 level. All statistical tests were two-sided and the p-values were rounded to 3 decimal places prior to determining statistical significance.|ANOVA|||||||<0.001
72353180|NCT00255190|144226362|SUPERIORITY_OR_OTHER|||||||0.758||95.0||||Statistical significance was determined at 0.05 level. All statistical tests were two-sided and the p-values were rounded to 3 decimal places prior to determining statistical significance.|ANOVA|||||||0.758
72353181|NCT00255190|144226363|SUPERIORITY_OR_OTHER|||||||0.737||95.0||||Statistical significance was determined at 0.05 level. All statistical tests were two-sided and the p-values were rounded to 3 decimal places prior to determining statistical significance.|ANOVA|||||||0.737
72353182|NCT00255190|144226364|SUPERIORITY_OR_OTHER|||||||0.673||95.0||||Statistical significance was determined at 0.05 level. All statistical tests were two-sided and the p-values were rounded to 3 decimal places prior to determining statistical significance.|ANOVA|||||||0.673
72353183|NCT00255190|144226365|SUPERIORITY_OR_OTHER|||||||0.817||95.0||||Statistical significance was determined at 0.05 level. All statistical tests were two-sided and the p-values were rounded to 3 decimal places prior to determining statistical significance.|ANOVA|||||||0.817
72353184|NCT00255190|144226366|SUPERIORITY_OR_OTHER|||||||0.601||95.0||||Statistical significance was determined at 0.05 level. All statistical tests were two-sided and the p-values were rounded to 3 decimal places prior to determining statistical significance.|ANOVA|||||||0.601
72353185|NCT00255190|144226367|SUPERIORITY_OR_OTHER|||||||0.065||95.0||||Statistical significance was determined at 0.05 level. All statistical tests were two-sided and the p-values were rounded to 3 decimal places prior to determining statistical significance.|ANOVA|||||||0.065
72353186|NCT00255190|144226368|SUPERIORITY_OR_OTHER|||||||0.319||95.0||||Statistical significance was determined at 0.05 level. All statistical tests were two-sided and the p-values were rounded to 3 decimal places prior to determining statistical significance.|ANOVA|||||||0.319
72353187|NCT00255190|144226369|SUPERIORITY_OR_OTHER|||||||0.011||95.0||||Statistical significance was determined at 0.05 level. All statistical tests were two-sided and the p-values were rounded to 3 decimal places prior to determining statistical significance.|ANOVA|||||||0.011
72353188|NCT00255190|144226370|SUPERIORITY_OR_OTHER|||||||0.207||95.0||||Statistical significance was determined at 0.05 level. All statistical tests were two-sided and the p-values were rounded to 3 decimal places prior to determining statistical significance.|ANOVA|||||||0.207
72353189|NCT00255190|144226371|SUPERIORITY_OR_OTHER|||||||0.286||95.0||||Statistical significance was determined at 0.05 level. All statistical tests were two-sided and the p-values were rounded to 3 decimal places prior to determining statistical significance.|ANCOVA|Comparisons were made using an ANCOVA model with treatment as the factor and baseline score as the covariate.||||||0.286
72353190|NCT00255190|144226372|SUPERIORITY_OR_OTHER|||||||0.102||95.0||||Statistical significance was determined at 0.05 level. All statistical tests were two-sided and the p-values were rounded to 3 decimal places prior to determining statistical significance.|ANCOVA|Comparisons were made using an ANCOVA model with treatment as the factor and baseline score as the covariate.||||||0.102
72353191|NCT00255190|144226373|SUPERIORITY_OR_OTHER|||||||0.656||95.0||||Statistical significance was determined at 0.05 level. All statistical tests were two-sided and the p-values were rounded to 3 decimal places prior to determining statistical significance.|ANCOVA|Comparisons were made using an ANCOVA model with treatment as the factor and baseline score as the covariate.||||||0.656
72353192|NCT00255190|144226374|SUPERIORITY_OR_OTHER|||||||0.176||95.0||||Statistical significance was determined at 0.05 level. All statistical tests were two-sided and the p-values were rounded to 3 decimal places prior to determining statistical significance.|ANCOVA|Comparisons were made using an ANCOVA model with treatment as the factor and baseline score as the covariate.||||||0.176
72353193|NCT00255190|144226375|SUPERIORITY_OR_OTHER|||||||0.03||95.0||||Statistical significance was determined at 0.05 level. All statistical tests were two-sided and the p-values were rounded to 3 decimal places prior to determining statistical significance.|ANCOVA|Comparisons were made using an ANCOVA model with treatment as the factor and baseline score as the covariate.||||||0.030
72353194|NCT00255190|144226376|SUPERIORITY_OR_OTHER|||||||0.243||95.0||||Statistical significance was determined at 0.05 level. All statistical tests were two-sided and the p-values were rounded to 3 decimal places prior to determining statistical significance.|ANCOVA|Comparisons were made using an ANCOVA model with treatment as the factor and baseline score as the covariate.||||||0.243
72353195|NCT00255190|144226377|SUPERIORITY_OR_OTHER|||||||0.005||95.0||||Statistical significance was determined at 0.05 level. All statistical tests were two-sided and the p-values were rounded to 3 decimal places prior to determining statistical significance.|ANCOVA|Comparisons were made using an ANCOVA model with treatment as the factor and baseline score as the covariate.||||||0.005
72353196|NCT00255190|144226378|SUPERIORITY_OR_OTHER|||||||0.469||95.0||||Statistical significance was determined at 0.05 level. All statistical tests were two-sided and the p-values were rounded to 3 decimal places prior to determining statistical significance.|ANCOVA|Comparisons were made using an ANCOVA model with treatment as the factor and baseline score as the covariate.||||||0.469
72353197|NCT03246789|144226420|SUPERIORITY||Mean Difference (Final Values)|2.15||||0.31|TWO_SIDED|95.0|-2.09|6.39|||t-test, 2 sided|||Week 12||6.39|-2.09|0.31
72353198|NCT03246789|144226421|SUPERIORITY||Mean Difference (Final Values)|-1.47||||0.28|TWO_SIDED|95.0|-4.22|1.28|||t-test, 2 sided|||Domain #1, Week 12||1.28|-4.22|0.28
72353199|NCT03246789|144226421|SUPERIORITY||Mean Difference (Final Values)|-0.87||||0.5|TWO_SIDED|95.0|-3.48|1.74|||t-test, 2 sided|||Domain #2, Week 12||1.74|-3.48|0.50
72353200|NCT03246789|144226421|SUPERIORITY||Mean Difference (Final Values)|-1.58||||0.02|TWO_SIDED|95.0|-2.88|-0.28|||t-test, 2 sided|||Domain #3, Week 12||-0.28|-2.88|0.02
72353201|NCT03246789|144226421|SUPERIORITY||Mean Difference (Final Values)|-0.05||||0.98|TWO_SIDED|95.0|-3.63|3.53|||t-test, 2 sided|||Domain 4, Week 12||3.53|-3.63|0.98
72353202|NCT03246789|144226422|SUPERIORITY||Mean Difference (Final Values)|-0.03||||0.92|TWO_SIDED|95.0|-0.64|0.58|||t-test, 2 sided|||Domain #1, Week 12||0.58|-0.64|0.92
72353203|NCT03246789|144226422|SUPERIORITY||Mean Difference (Final Values)|-0.18||||0.48|TWO_SIDED|95.0|-0.69|0.33|||t-test, 2 sided|||Domain #2, Week 12||0.33|-0.69|0.48
72353204|NCT03246789|144226422|SUPERIORITY||Mean Difference (Final Values)|0.18||||0.48|TWO_SIDED|95.0|-0.33|0.69|||t-test, 2 sided|||||0.69|-0.33|0.48
72353205|NCT01216202|144226423|SUPERIORITY|||||||0.014||||||The threshold for statistical significance was p = 0.05.|Regression, Linear|||The association between change in serum testosterone levels and cumulative mean testicular radiation dose was assessed using longitudinal regression analysis (GEE). No preoperative RT contributed with baseline values.||||0.014
72353206|NCT01216202|144226424|SUPERIORITY||Estimated mean change|-4.0||||0.008|TWO_SIDED|95.0|-6.9|-1.0||The threshold for statistical significance was p=0.05.|Regression, Linear|Model adjusted for time between preoperative radiotherapy (RT) and surgery.||The association between change in total number of sperms per ejaculate and relative mean testicular dose was assessed using longitudinal regression analysis (GEE).||-1.0|-6.9|0.008
72353207|NCT02673918|144226457|EQUIVALENCE|Differences (the number of participants in each of the three categories) between baseline and follow-up was calculated using a Wilcoxon signed-rank test. This was a feasibility test and no power calculation was performed.||||||0.05|||||||Wilcoxon (Mann-Whitney)|||||||0.05
72353208|NCT02673918|144226458|EQUIVALENCE|Differences (the number of participants in each of the three categories) between baseline and follow-up was calculated using a Wilcoxon signed-rank test. This was a feasibility test and no power calculation was performed.||||||0.05|||||||Wilcoxon (Mann-Whitney)|||||||0.05
72353209|NCT02927392|144226463|OTHER||||||<|0.0001|||||||ANOVA|||||||<0.0001
72353210|NCT04532034|144226467|OTHER||Mean Difference (Final Values)|0.067||||0.95|TWO_SIDED||||||t-test, 2 sided|||||||.95
72353211|NCT04037891|144226474|SUPERIORITY||Difference of percentage of participants|16.7|||||TWO_SIDED|95.0|-53.57|72.99||||||||72.99|-53.57|
72353212|NCT04037891|144226474|SUPERIORITY||Difference of percentage of participants|33.3|||||TWO_SIDED|95.0|-25.45|78.39||||||Comparison of incidence of ocular TEAE in all patients receiving rVA576 (part 1 and 2) vs placebo||78.39|-25.45|
72353213|NCT05274958|144226480|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|||Patient measures for both groups were first summarized descriptively with means and standard deviations. To compare the two groups, a t-test was used.||||<0.05
72353214|NCT01307319|144226493|SUPERIORITY_OR_OTHER||LSM treatment difference from placebo|-0.63|||<|0.001|TWO_SIDED|95.0|-1.0|-0.3||a priori statistical significance is \<0.05.|mixed-model for repeated measures (MMRM)|The MMRM included covariate adjustment for baseline, day, treatment, and the treatment by day interaction.||||-0.3|-1.0|<0.001
72353215|NCT01307319|144226493|SUPERIORITY_OR_OTHER||LSM treatment difference from placebo|-0.73|||<|0.001|TWO_SIDED|95.0|-1.1|-0.4||a priori statistical significance is \<0.05.|mixed-model for repeated measures (MMRM)|The MMRM included covariate adjustment for baseline, day, treatment, and the treatment by day interaction.||||-0.4|-1.1|<0.001
72353216|NCT01307319|144226494|SUPERIORITY_OR_OTHER||LSM treatment difference from placebo|-0.71|||<|0.001|TWO_SIDED|95.0|-1.1|-0.3||a priori statistical significance is \<0.05.|mixed-model for repeated measures (MMRM)|The MMRM included covariate adjustment for baseline, day, treatment, and the treatment by day interaction.||The power calculation assumed the standard deviation (SD) for the change from baseline over two weeks in the average of AM and PM reflective TNSS is assumed to be 2.0. Using this standard deviation, 235 subjects per arm provides 90% power to detect a difference of 0.60 in TNSS change from baseline between treatment groups with a two-sided alpha level of 0.05.||-0.3|-1.1|<0.001
72353217|NCT01307319|144226494|SUPERIORITY_OR_OTHER||LSM treatment difference from placebo|-0.76|||<|0.001|TWO_SIDED|95.0|-1.1|-0.4||a priori statistical significance is \<0.05.|mixed-model for repeated measures (MMRM)|The MMRM included covariate adjustment for baseline, day, treatment, and the treatment by day interaction.||||-0.4|-1.1|<0.001
72353218|NCT02648204|144226538|NON_INFERIORITY|Non-Inferiority margin: 0.4|Treatment difference|-0.4|STANDARD_ERROR_OF_MEAN|0.08|<|0.0001|TWO_SIDED|95.0|-0.55|-0.25|||Mixed Models Analysis|||||-0.25|-0.55|<0.0001
72353219|NCT02648204|144226538|SUPERIORITY||Treatment difference|-0.4|STANDARD_ERROR_OF_MEAN|0.08|<|0.0001|TWO_SIDED|95.0|-0.55|-0.25|||Mixed Models Analysis|||||-0.25|-0.55|<0.0001
72353220|NCT02648204|144226538|NON_INFERIORITY|Non-Inferiority margin: 0.04|Treatment difference|-0.41|STANDARD_ERROR_OF_MEAN|0.08|<|0.0001|TWO_SIDED|95.0|-0.57|-0.25|||Mixed Models Analysis|||||-0.25|-0.57|<0.0001
72353221|NCT02648204|144226538|SUPERIORITY||Treatment difference|-0.41|STANDARD_ERROR_OF_MEAN|0.08|<|0.0001|TWO_SIDED|95.0|-0.57|-0.25|||Mixed Models Analysis|||||-0.25|-0.57|<0.0001
72353222|NCT02648204|144226539|SUPERIORITY||Treatment difference|-2.26|STANDARD_ERROR_OF_MEAN|0.39|<|0.0001|TWO_SIDED|95.0|-3.02|-1.51|||Mixed Models Analysis|||||-1.51|-3.02|<0.0001
72353223|NCT02648204|144226539|SUPERIORITY||Treatment difference|-3.55|STANDARD_ERROR_OF_MEAN|0.39|<|0.0001|TWO_SIDED|95.0|-4.32|-2.78|||Mixed Models Analysis|||||-2.78|-4.32|<0.0001
72353224|NCT01507688|144226570|SUPERIORITY||Mean Difference (Net)|0.14|STANDARD_ERROR_OF_MEAN|0.17||0.05|TWO_SIDED|||||P-value was not adjusted for multiple comparisons. Models adjusted for: VA vs Non Va, admission diagnosis (transient ischemic attack vs stroke), sex (male vs female), white vs nonwhite, and baseline total Stroke Specific Quality of life score.|Mixed Models Analysis|Repeated measurements of change GEE analyses of Total Stroke Specific Quality of Life score change at 6 months from baseline.|The adjusted positive mean (standard error) change at 6 months from baseline was higher in the intervention arm compared to in the control arm. Intervention group had 0.14 (SE 0.17) higher improvement compared to the control group.|"All the sample size calculations were powered at 80% with a 5% Type I error. We estimated based on our pilot study a change difference of 0.25 on Total Stroke Specific Quality of Life in the intervention group compared to no change in the control group at 6 months. Our power calculations estimated a sample of 226 (113) per group was needed to detect this effect. We used primary outcome row Mean Change from 0 to 6 months for this analysis."||||0.0500
72353225|NCT01507688|144226570|SUPERIORITY||Mean Difference (Net)|0.22|STANDARD_ERROR_OF_MEAN|0.04||0.26|TWO_SIDED|||||Adjusted least square means (standard errors) adjusted for treatment (Intervention vs control), time of outcome from baseline (3, 6, 12 months), baseline SSQoL, Site (VA vs NonVA), Stroke/TIA diagnosis, sex (m vs f) and race (white vs nonwhite).|Mixed Models Analysis||Adjusted intervention arm's positive change (regression coefficient with standard error) in Total Stroke Specific Quality of Life was not significantly different at 12 months compared to the control group.|"We evaluated the mean difference on Total Stroke Specific Quality of Life compared to baseline between the intervention and control groups at 12 months using repeated measures ANCOVA models. We used primary outcome row Mean change from 0 to 12 months for this analysis."||||0.26
72353226|NCT02341235|144226571|SUPERIORITY|||||||0.35|||||||ANCOVA|||All analyses were adjusted for baseline values, age, race, ethnicity, and time since diagnosis.||||.35
72353227|NCT02341235|144226572|SUPERIORITY|||||||0.22|||||||ANCOVA|||All analyses were adjusted for baseline values, age, race, ethnicity, and time since diagnosis.||||0.22
72353228|NCT02341235|144226573|SUPERIORITY|||||||0.97|||||||ANCOVA|||All analyses were adjusted for baseline values, age, race, ethnicity, and time since diagnosis.||||.97
72353229|NCT02341235|144226574|SUPERIORITY|||||||0.98|||||||ANCOVA|||All analyses were adjusted for baseline values, age, race, ethnicity, and time since diagnosis.||||.98
72353230|NCT02341235|144226575|SUPERIORITY|||||||0.83|||||||ANCOVA|||All analyses were adjusted for baseline values, age, race, ethnicity, and time since diagnosis.||||.83
72353231|NCT02341235|144226576|SUPERIORITY|||||||0.055|||||||ANCOVA|||All analyses were adjusted for baseline values, age, race, ethnicity, and time since diagnosis.||||.055
72353232|NCT02341235|144226577|SUPERIORITY|||||||0.71|||||||ANCOVA|||All analyses were adjusted for baseline values, age, race, ethnicity, and time since diagnosis.||||.71
72353233|NCT02341235|144226578|SUPERIORITY|||||||0.33|||||||ANCOVA|||All analyses were adjusted for baseline values, age, race, ethnicity, and time since diagnosis.||||.33
72353234|NCT02341235|144226579|SUPERIORITY|||||||0.94|||||||ANCOVA|||All analyses were adjusted for baseline values, age, race, ethnicity, and time since diagnosis.||||.94
72353235|NCT02341235|144226580|SUPERIORITY|||||||0.57|||||||ANCOVA|||All analyses were adjusted for baseline values, age, race, ethnicity, and time since diagnosis.||||.57
72353236|NCT02341235|144226581|SUPERIORITY|||||||0.3|||||||ANCOVA|||All analyses were adjusted for baseline values, age, race, ethnicity, and time since diagnosis.||||.30
72353237|NCT02341235|144226582|SUPERIORITY|||||||0.44|||||||ANCOVA|||All analyses were adjusted for baseline values, age, race, ethnicity, and time since diagnosis.||||.44
72353238|NCT02341235|144226583|SUPERIORITY|||||||0.62|||||||ANCOVA|||All analyses were adjusted for baseline values, age, race, ethnicity, and time since diagnosis.||||.62
72353239|NCT02341235|144226584|SUPERIORITY|||||||0.7|||||||ANCOVA|||All analyses were adjusted for baseline values, age, race, ethnicity, and time since diagnosis.||||.70
72353240|NCT02341235|144226585|SUPERIORITY|||||||0.41|||||||ANCOVA|||All analyses were adjusted for baseline values, age, race, ethnicity, and time since diagnosis.||||.41
72353241|NCT02341235|144226586|SUPERIORITY|||||||0.72|||||||ANCOVA|||All analyses were adjusted for baseline values, age, race, ethnicity, and time since diagnosis.||||.72
72353242|NCT02341235|144226593|SUPERIORITY|||||||0.084|||||||ANCOVA|||||||0.084
72353243|NCT02341235|144226595|SUPERIORITY|||||||0.58|||||||ANCOVA|||||||0.580
72353244|NCT02341235|144226603|SUPERIORITY|||||||0.461|||||||ANCOVA|||||||0.461
72353245|NCT02341235|144226605|SUPERIORITY|||||||0.934|||||||ANCOVA|||||||0.934
72353246|NCT02163824|144226607|SUPERIORITY||Difference in % of responders|16.1||||0.0024|TWO_SIDED|95.0|5.9|26.4|||Chi-squared||Estimated Value is the between-group difference for % of responders and is expressed as a percentage.|"All statistical tests of hypotheses performed for the pairwise comparison of means were two-sided.~All statistical tests employed a level of significance of alpha = 0.05."||26.4|5.9|.0024
72353247|NCT02163824|144226607|SUPERIORITY||Difference in % of responders|22.1|||<|0.0001|TWO_SIDED|95.0|11.7|32.6|||Chi-squared||Estimated Value is the between-group difference for % of responders and is expressed as a percentage.|"All statistical tests of hypotheses performed for the pairwise comparison of means were two-sided.~All statistical tests employed a level of significance of alpha = 0.05."||32.6|11.7|<.0001
72353248|NCT02163824|144226608|SUPERIORITY||Difference in % of responders|19.5||||0.0019|TWO_SIDED|95.0|7.4|31.5|||Chi-squared||Estimated Value is the between-group difference for % of responders and is expressed as a percentage.|"All statistical tests of hypotheses performed for the pairwise comparison of means were two-sided.~All statistical tests employed a level of significance of alpha = 0.05."||31.5|7.4|.0019
72353249|NCT02163824|144226608|SUPERIORITY||Difference in % of responders|22.5||||0.0003|TWO_SIDED|95.0|10.6|34.4|||Chi-squared||Estimated Value is the between-group difference for % of responders and is expressed as a percentage.|"All statistical tests of hypotheses performed for the pairwise comparison of means were two-sided.~All statistical tests employed a level of significance of alpha = 0.05."||34.4|10.6|.0003
72353250|NCT02163824|144226609|SUPERIORITY||Mean Difference (Final Values)|-0.3||||0.0007|TWO_SIDED||||||ANCOVA||Estimated value is the between-group difference in mean AC grade at Day 8.|||||0.0007
72353251|NCT02163824|144226609|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.044|TWO_SIDED||||||ANCOVA||Estimated value is the between-group difference in mean grade AC at Day 8.|||||0.0440
72353252|NCT02163824|144226610|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.0391|TWO_SIDED||||||ANCOVA||Estimated value is the between-group difference in mean AC grade at Day 15.|||||0.0391
72353253|NCT02163824|144226610|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.1811|TWO_SIDED||||||ANCOVA||Estimated value is the between-group difference in mean AC grade at Day 15.|||||0.1811
72353254|NCT02163824|144226611|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.1953|TWO_SIDED||||||ANCOVA||Estimated value is the between-group difference in mean ocular pain grade at Day 8.|||||0.1953
72353255|NCT02163824|144226611|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.0307|TWO_SIDED||||||ANCOVA||Estimated value is the between group difference of mean ocular pain grade at Day 8.|||||0.0307
72353256|NCT02163824|144226612|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.2589|TWO_SIDED||||||ANCOVA||Estimated value is the between-group difference on mean ocular pain score at Day 15.|||||0.2589
72353257|NCT02163824|144226612|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.2132|TWO_SIDED||||||ANCOVA||Estimated value is the between-group difference in mean ocular pain score at Day 15.|||||0.2132
72353258|NCT01272232|144226649|SUPERIORITY_OR_OTHER||Treatment contrast|-3.97|||<|0.0001||95.0|-4.84|-3.11||Superiority was established only if all preceding hypotheses had been rejected. p values are 2-sided; 5% pre-defined significance level.|ANCOVA|||The 3 co-primary endpoints (Outcome Measures 1, 2 and 3) were ranked (#1, 2, 3); hypotheses of no difference were tested in a hierarchical manner. Fixed factors: treatment, country, sex, background treatment, baseline HbA1c stratum, background treatment/HbA1c-stratum-interaction; covariate: baseline value.||-3.11|-4.84|<0.0001
72353259|NCT01272232|144226649|SUPERIORITY_OR_OTHER||Treatment contrast|-2.62|||<|0.0001||95.0|-3.63|-1.62||Superiority was established only if all preceding hypotheses had been rejected. p values are 2-sided; 5% pre-defined significance level.|ANCOVA|||The 3 co-primary endpoints (Outcome Measures 1, 2 and 3) were ranked (#1, 2, 3); hypotheses of no difference were tested in a hierarchical manner. Fixed factors: treatment, country, sex, background treatment, baseline HbA1c stratum, background treatment/HbA1c-stratum-interaction; covariate: baseline value.||-1.62|-3.63|<0.0001
72353260|NCT01272232|144226649|SUPERIORITY_OR_OTHER||Treatment contrast|-1.35||||0.0024||95.0|-2.23|-0.48||Superiority was established only if all preceding hypotheses had been rejected. p values are 2-sided; 5% pre-defined significance level.|ANCOVA|||The 3 co-primary endpoints (Outcome Measures 1, 2 and 3) were ranked (#1, 2, 3); hypotheses of no difference were tested in a hierarchical manner. Fixed factors: treatment, country, sex, background treatment, baseline HbA1c stratum, background treatment/HbA1c-stratum-interaction; covariate: baseline value.||-0.48|-2.23|0.0024
72353261|NCT01272232|144226650|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.81|||<|0.0001||95.0|4.34|10.68||Superiority was established only if all preceding hypotheses had been rejected. p values are 2-sided; 5% pre-defined significance level.|Regression, Logistic|||The 3 co-primary endpoints (Outcome Measures 1, 2 and 3) were ranked (#1, 2, 3); hypotheses of no difference were tested in a hierarchical manner. Fixed factors: treatment, country, sex, background treatment, baseline HbA1c stratum, background treatment/HbA1c-stratum-interaction; covariate: baseline value.||10.68|4.34|<0.0001
72369523|NCT00740857|144249267|SUPERIORITY_OR_OTHER||||||<|0.001|||||||proportional hazards model|Adjusted with treatment, baseline Pain Severity Rating (PSR), and gender terms.||||||<0.001
72353262|NCT01272232|144226650|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.69|||<|0.0001||95.0|2.24|6.09||Superiority was established only if all preceding hypotheses had been rejected. p values are 2-sided; 5% pre-defined significance level.|Regression, Logistic|||The 3 co-primary endpoints (Outcome Measures 1, 2 and 3) were ranked (#1, 2, 3); hypotheses of no difference were tested in a hierarchical manner. Fixed factors: treatment, country, sex, background treatment, baseline HbA1c stratum, background treatment/HbA1c-stratum-interaction; covariate: baseline value.||6.09|2.24|<0.0001
72353263|NCT01272232|144226650|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.84||||0.0008||95.0|1.29|2.64||Superiority was established only if all preceding hypotheses had been rejected. p values are 2-sided; 5% pre-defined significance level.|Regression, Logistic|||The 3 co-primary endpoints (Outcome Measures 1, 2 and 3) were ranked (#1, 2, 3); hypotheses of no difference were tested in a hierarchical manner. Fixed factors: treatment, country, sex, background treatment, baseline HbA1c stratum, background treatment/HbA1c-stratum-interaction; covariate: baseline value.||2.64|1.29|0.0008
72353264|NCT01272232|144226651|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|7.1|||<|0.0001||95.0|3.48|14.48||Superiority was established only if all preceding hypotheses had been rejected. p values are 2-sided; 5% pre-defined significance level.|Regression, Logistic|||The 3 co-primary endpoints (Outcome Measures 1, 2 and 3) were ranked (#1, 2, 3); hypotheses of no difference were tested in a hierarchical manner. Fixed factors: treatment, country, sex, background treatment, baseline HbA1c stratum, background treatment/HbA1c-stratum-interaction; covariate: baseline value.||14.48|3.48|<0.0001
72353265|NCT01272232|144226651|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.84||||0.0008||95.0|1.75|8.41||Superiority was established only if all preceding hypotheses had been rejected. p values are 2-sided; 5% pre-defined significance level.|Regression, Logistic|||The 3 co-primary endpoints (Outcome Measures 1, 2 and 3) were ranked (#1, 2, 3); hypotheses of no difference were tested in a hierarchical manner. Fixed factors: treatment, country, sex, background treatment, baseline HbA1c stratum, background treatment/HbA1c-stratum-interaction; covariate: baseline value.||8.41|1.75|0.0008
72353266|NCT01272232|144226651|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.85||||0.0099||95.0|1.16|2.95||Superiority was established only if all preceding hypotheses had been rejected. p values are 2-sided; 5% pre-defined significance level.|Regression, Logistic|||The 3 co-primary endpoints (Outcome Measures 1, 2 and 3) were ranked (#1, 2, 3); hypotheses of no difference were tested in a hierarchical manner. Fixed factors: treatment, country, sex, background treatment, baseline HbA1c stratum, background treatment/HbA1c-stratum-interaction; covariate: baseline value.||2.95|1.16|0.0099
72353267|NCT01272232|144226652|SUPERIORITY_OR_OTHER||Treatment contrast|-0.93|||<|0.0001||95.0|-1.08|-0.78||p values are 2-sided; 5% pre-defined significance level.|ANCOVA|||Test of no difference. Fixed factors: treatment, country, sex, background treatment, baseline HbA1c stratum, background treatment/HbA1c-stratum-interaction; covariate: baseline value.||-0.78|-1.08|<0.0001
72353268|NCT01272232|144226652|SUPERIORITY_OR_OTHER||Treatment contrast|-0.74|||<|0.0001||95.0|-0.91|-0.57||p values are 2-sided; 5% pre-defined significance level.|ANCOVA|||Test of no difference. Fixed factors: treatment, country, sex, background treatment, baseline HbA1c stratum, background treatment/HbA1c-stratum-interaction; covariate: baseline value.||-0.57|-0.91|<0.0001
72353269|NCT01272232|144226652|SUPERIORITY_OR_OTHER||Treatment contrast|-0.19||||0.0125||95.0|-0.34|-0.04||p values are 2-sided; 5% pre-defined significance level.|ANCOVA|||Test of no difference. Fixed factors: treatment, country, sex, background treatment, baseline HbA1c stratum, background treatment/HbA1c-stratum-interaction; covariate: baseline value.||-0.04|-0.34|0.0125
72353270|NCT01272232|144226653|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|8.79|||<|0.0001||95.0|5.74|13.4||p values are 2-sided; 5% pre-defined significance level.|Regression, Logistic|||Test of no difference. Fixed factors: treatment, country, sex, background treatment, baseline HbA1c stratum, background treatment/HbA1c-stratum-interaction; covariate: baseline value.||13.4|5.74|<0.0001
72353271|NCT01272232|144226653|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|7.71|||<|0.0001||95.0|4.76|12.51||p values are 2-sided; 5% pre-defined significance level.|Regression, Logistic|||Test of no difference. Fixed factors: treatment, country, sex, background treatment, baseline HbA1c stratum, background treatment/HbA1c-stratum-interaction; covariate: baseline value.||12.51|4.76|<0.0001
72353272|NCT01272232|144226653|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.14||||0.5319||95.0|0.76|1.71||p values are 2-sided; 5% pre-defined significance level.|Regression, Logistic|||Test of no difference. Fixed factors: treatment, country, sex, background treatment, baseline HbA1c stratum, background treatment/HbA1c-stratum-interaction; covariate: baseline value.||1.71|0.76|0.5319
72353273|NCT01272232|144226654|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|9.61|||<|0.0001||95.0|6.05|15.26||p values are 2-sided; 5% pre-defined significance level.|Regression, Logistic|||Test of no difference. Fixed factors: treatment, country, sex, background treatment, baseline HbA1c stratum, background treatment/HbA1c-stratum-interaction; covariate: baseline value.||15.26|6.05|<0.0001
72353274|NCT01272232|144226654|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.98|||<|0.0001||95.0|3.59|9.97||p values are 2-sided; 5% pre-defined significance level.|Regression, Logistic|||Test of no difference. Fixed factors: treatment, country, sex, background treatment, baseline HbA1c stratum, background treatment/HbA1c-stratum-interaction; covariate: baseline value.||9.97|3.59|<0.0001
72353275|NCT01272232|144226654|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.61||||0.0142||95.0|1.1|2.34||p values are 2-sided; 5% pre-defined significance level.|Regression, Logistic|||Test of no difference. Fixed factors: treatment, country, sex, background treatment, baseline HbA1c stratum, background treatment/HbA1c-stratum-interaction; covariate: baseline value.||2.34|1.10|0.0142
72353276|NCT01272232|144226655|SUPERIORITY_OR_OTHER||Treatment contrast|-3.22|||<|0.0001||95.0|-4.2|-2.23||p values are 2-sided; 5% pre-defined significance level.|ANCOVA|||Test of no difference. Fixed factors: treatment, country, sex, background treatment, baseline HbA1c stratum, background treatment/HbA1c-stratum-interaction; covariate: baseline value.||-2.23|-4.20|<0.0001
72369524|NCT03532451|144249274|SUPERIORITY|||||||0.08|||||||Wilcoxon Signed-Rank Test|||Null hypothesis is the change in CD8+ cell density is not significantly different from zero.||||0.08
72353277|NCT01272232|144226655|SUPERIORITY_OR_OTHER||Treatment contrast|-2.06||||0.0004||95.0|-3.2|-0.92||p values are 2-sided; 5% pre-defined significance level.|ANCOVA|||Test of no difference. Fixed factors: treatment, country, sex, background treatment, baseline HbA1c stratum, background treatment/HbA1c-stratum-interaction; covariate: baseline value.||-0.92|-3.20|0.0004
72353278|NCT01272232|144226655|SUPERIORITY_OR_OTHER||Treatment contrast|-1.16||||0.0224||95.0|-2.16|-0.16||p values are 2-sided; 5% pre-defined significance level.|ANCOVA|||Test of no difference. Fixed factors: treatment, country, sex, background treatment, baseline HbA1c stratum, background treatment/HbA1c-stratum-interaction; covariate: baseline value.||-0.16|-2.16|0.0224
72353279|NCT01272232|144226656|SUPERIORITY_OR_OTHER||Treatment contrast|-2.17||||0.0002||95.0|-3.32|-1.02||p values are 2-sided; 5% pre-defined significance level.|ANCOVA|||Test of no difference. Fixed factors: treatment, country, sex, background treatment, baseline HbA1c stratum, background treatment/HbA1c-stratum-interaction; covariate: baseline value.||-1.02|-3.32|0.0002
72353280|NCT01272232|144226656|SUPERIORITY_OR_OTHER||Treatment contrast|-1.2||||0.0725||95.0|-2.51|0.11||p values are 2-sided; 5% pre-defined significance level.|ANCOVA|||Test of no difference. Fixed factors: treatment, country, sex, background treatment, baseline HbA1c stratum, background treatment/HbA1c-stratum-interaction; covariate: baseline value.||0.11|-2.51|0.0725
72353281|NCT01272232|144226656|SUPERIORITY_OR_OTHER||Treatment contrast|-0.97||||0.0717||95.0|-2.02|0.09||p values are 2-sided; 5% pre-defined significance level.|ANCOVA|||Test of no difference. Fixed factors: treatment, country, sex, background treatment, baseline HbA1c stratum, background treatment/HbA1c-stratum-interaction; covariate: baseline value.||0.09|-2.02|0.0717
72353282|NCT01272232|144226658|SUPERIORITY_OR_OTHER||Treatment contrast|-2.49|||<|0.0001||95.0|-3.75|-1.24||p values are 2-sided; 5% pre-defined significance level.|ANCOVA|||Test of no difference. Fixed factors: treatment, country, sex, background treatment, baseline HbA1c stratum, background treatment/HbA1c-stratum-interaction; covariate: baseline value.||-1.24|-3.75|<0.0001
72353283|NCT01272232|144226658|SUPERIORITY_OR_OTHER||Treatment contrast|-1.47||||0.0457||95.0|-2.92|-0.03||p values are 2-sided; 5% pre-defined significance level.|ANCOVA|||Test of no difference. Fixed factors: treatment, country, sex, background treatment, baseline HbA1c stratum, background treatment/HbA1c-stratum-interaction; covariate: baseline value.||-0.03|-2.92|0.0457
72353284|NCT01272232|144226658|SUPERIORITY_OR_OTHER||Treatment contrast|-1.02||||0.0961||95.0|-2.22|0.18||p values are 2-sided; 5% pre-defined significance level.|ANCOVA|||Test of no difference. Fixed factors: treatment, country, sex, background treatment, baseline HbA1c stratum, background treatment/HbA1c-stratum-interaction; covariate: baseline value.||0.18|-2.22|0.0961
72353285|NCT00628030|144226669|SUPERIORITY_OR_OTHER|||||||0.008|TWO_SIDED||||||Chi-squared|||||||.008
72353286|NCT00628030|144226670|SUPERIORITY_OR_OTHER|||||||0.041|TWO_SIDED||||||Chi-squared|||||||.041
72353287|NCT00628030|144226671|SUPERIORITY_OR_OTHER|||||||0.61|TWO_SIDED||||||Chi-squared|||||||.61
72353288|NCT00628030|144226672|SUPERIORITY_OR_OTHER|||||||0.13|TWO_SIDED||||||Chi-squared|||||||0.13
72353289|NCT00628030|144226673|SUPERIORITY_OR_OTHER|||||||0.024|TWO_SIDED||||||Chi-squared|||||||.024
72353290|NCT03367858|144226689|SUPERIORITY|||||||0.0173||||||At 12 month follow up.|ANCOVA|||We conducted a repeated measures ANCOVA of Time (Post-Treatment: 3, 6, 12 months) × Treatment (MI, BAM) with the covariate of pre-treatment problem drinking.||||.0173
72353291|NCT03827655|144226740|SUPERIORITY||Hazard Ratio (HR)|0.92|||=|0.649|TWO_SIDED|90.0|0.63|1.33||P-values were derived using a one-sided test with alternative hypothesis (Ha): Hazard Ratio\>1.|Wald chi-square test||Hazard ratios, 90% confidence intervals (CIs) and associated Wald Chi-square p-values between TAK-954 dose levels and placebo were obtained using a stratified Cox proportional hazard model with treatment as the only independent variable.|||1.33|0.63|=0.649
72353292|NCT03827655|144226740|SUPERIORITY||Hazard Ratio (HR)|1.0|||=|0.505|TWO_SIDED|90.0|0.69|1.43||P-values were derived using a one-sided test with alternative hypothesis (Ha): Hazard Ratio\>1.|Wald chi-square test||Hazard ratios, 90% CIs and associated Wald Chi-square p-values between TAK-954 dose levels and placebo are obtained using a stratified Cox proportional hazard model with treatment as the only independent variable.|||1.43|0.69|=0.505
72353293|NCT03827655|144226741|SUPERIORITY||Hazard Ratio (HR)|1.03|||=|0.449|TWO_SIDED|90.0|0.71|1.49||P-values were derived using a one-sided test with alternative hypothesis (Ha): Hazard Ratio\>1.|Wald chi-square test||Hazard ratios, 90% CIs and associated Wald Chi-square p-values between TAK-954 dose levels and placebo are obtained using a stratified Cox proportional hazard model with treatment as the only independent variable.|||1.49|0.71|=0.449
72353294|NCT03827655|144226741|SUPERIORITY||Hazard Ratio (HR)|1.0|||=|0.507|TWO_SIDED|90.0|0.69|1.44||P-values were derived using a one-sided test with alternative hypothesis (Ha): Hazard Ratio\>1.|Wald chi-square test||Hazard ratios, 90% CIs and associated Wald Chi-square p-values between TAK-954 dose levels and placebo are obtained using a stratified Cox proportional hazard model with treatment as the only independent variable.|||1.44|0.69|=0.507
72353295|NCT03827655|144226742|SUPERIORITY||Hazard Ratio (HR)|1.05|||=|0.406|TWO_SIDED|90.0|0.73|1.52||P-values were derived using a one-sided test with alternative hypothesis (Ha): Hazard Ratio\>1.|Wald chi-square test||Hazard ratios, 90% CIs and associated Wald Chi-square p-values between TAK-954 dose levels and placebo are obtained using a stratified Cox proportional hazard model with treatment as the only independent variable.|||1.52|0.73|=0.406
72353296|NCT03827655|144226742|SUPERIORITY||Hazard Ratio (HR)|0.77|||=|0.88|TWO_SIDED|90.0|0.54|1.11||P-values were derived using a one-sided test with alternative hypothesis (Ha): Hazard Ratio\>1.|Wald chi-square test||Hazard ratios, 90% CIs and associated Wald Chi-square p-values between TAK-954 dose levels and placebo are obtained using a stratified Cox proportional hazard model with treatment as the only independent variable.|||1.11|0.54|=0.880
72353297|NCT03827655|144226743|SUPERIORITY||Hazard Ratio (HR)|1.03|||=|0.446|TWO_SIDED|90.0|0.72|1.48||P-values were derived using a one-sided test with alternative hypothesis (Ha): Hazard Ratio\>1.|Wald chi-square test||Hazard ratios, 90% CIs and associated Wald Chi-square p-values between TAK-954 dose levels and placebo are obtained using a stratified Cox proportional hazard model with treatment as the only independent variable.|||1.48|0.72|=0.446
72353298|NCT03827655|144226743|SUPERIORITY||Hazard Ratio (HR)|0.76|||=|0.892|TWO_SIDED|90.0|0.53|1.09||P-values were derived using a one-sided test with alternative hypothesis (Ha): Hazard Ratio\>1.|Wald chi-square test||Hazard ratios, 90% CIs and associated Wald Chi-square p-values between TAK-954 dose levels and placebo are obtained using a stratified Cox proportional hazard model with treatment as the only independent variable.|||1.09|0.53|=0.892
72353299|NCT03827655|144226744|SUPERIORITY||Hazard Ratio (HR)|0.86|||=|0.76|TWO_SIDED|90.0|0.6|1.23||P-values were derived using a one-sided test with alternative hypothesis (Ha): Hazard Ratio\>1.|Wald chi-square test||Hazard ratios, 90% CIs and associated Wald Chi-square p-values between TAK-954 dose levels and placebo are obtained using a stratified Cox proportional hazard model with treatment as the only independent variable.|||1.23|0.60|=0.760
72353300|NCT03827655|144226744|SUPERIORITY||Hazard Ratio (HR)|0.83|||=|0.81|TWO_SIDED|90.0|0.58|1.18||P-values were derived using a one-sided test with alternative hypothesis (Ha): Hazard Ratio\>1.|Wald chi-squared test||Hazard ratios, 90% CIs and associated Wald Chi-square p-values between TAK-954 dose levels and placebo are obtained using a stratified Cox proportional hazard model with treatment as the only independent variable.|||1.18|0.58|=0.810
72353301|NCT03827655|144226745|SUPERIORITY||Hazard Ratio (HR)|1.13|||=|0.288|TWO_SIDED|90.0|0.78|1.64||P-values were derived using a one-sided test with alternative hypothesis (Ha): Hazard Ratio\>1.|Wald chi-square test||Hazard ratios, 90% CIs and associated Wald Chi-square p-values between TAK-954 dose levels and placebo are obtained using a stratified Cox proportional hazard model with treatment as the only independent variable.|||1.64|0.78|=0.288
72353302|NCT03827655|144226745|SUPERIORITY||Hazard Ratio (HR)|1.03|||=|0.453|TWO_SIDED|90.0|0.72|1.47||P-values were derived using a one-sided test with alternative hypothesis (Ha): Hazard Ratio\>1.|Wald chi-square test||Hazard ratios, 90% CIs and associated Wald Chi-square p-values between TAK-954 dose levels and placebo are obtained using a stratified Cox proportional hazard model with treatment as the only independent variable.|||1.47|0.72|=0.453
72353303|NCT03827655|144226746|SUPERIORITY||Risk Difference (RD)|-0.09|||=|0.046|TWO_SIDED|90.0|-0.17|0.0||P-value was derived using a one-sided test with Ha: Risk Difference\<0.|Stratified Miettinen and Nurminen||The p-values, risk differences and corresponding 90% CIs were obtained using a stratified Miettinen and Nurminen approach with strata weighting by sample size.|||0.00|-0.17|=0.046
72353304|NCT03827655|144226746|SUPERIORITY||Risk Difference (RD)|0.0|||=|0.516|TWO_SIDED|90.0|-0.11|0.11||P-value was derived using a one-sided test with Ha: Risk Difference\<0.|Stratified Miettinen and Nurminen||The p-values, risk differences and corresponding 90% CIs were obtained using a stratified Miettinen and Nurminen approach with strata weighting by sample size.|||0.11|-0.11|=0.516
72353305|NCT03827655|144226747|SUPERIORITY||Risk Difference (RD)|-0.03|||=|0.296|TWO_SIDED|90.0|-0.12|0.06||P-value was derived using a one-sided test with Ha: Risk Difference\<0.|Stratified Miettinen and Nurminen||The p-values, risk differences and corresponding 90% CIs were obtained using a stratified Miettinen and Nurminen approach with strata weighting by sample size.|||0.06|-0.12|=0.296
72353306|NCT03827655|144226747|SUPERIORITY||Risk Difference (RD)|0.03|||=|0.677|TWO_SIDED|90.0|-0.07|0.13||P-value was derived using a one-sided test with Ha: Risk Difference\<0.|Stratified Miettinen and Nurminen||The p-values, risk differences and corresponding 90% CIs were obtained using a stratified Miettinen and Nurminen approach with strata weighting by sample size.|||0.13|-0.07|=0.677
72353307|NCT03827655|144226748|SUPERIORITY||Hazard Ratio (HR)|1.1|||=|0.338|TWO_SIDED|90.0|0.76|1.57||P-values were derived using a one-sided test with alternative hypothesis (Ha): Hazard Ratio\>1.|Wald chi-square test||Hazard ratios, 90% CIs and associated Wald Chi-square p-values between TAK-954 dose levels and placebo are obtained using a stratified Cox proportional hazard model with treatment as the only independent variable.|||1.57|0.76|=0.338
72353308|NCT03827655|144226748|SUPERIORITY||Hazard Ratio (HR)|1.04|||=|0.422|TWO_SIDED|90.0|0.73|1.49||P-values were derived using a one-sided test with alternative hypothesis (Ha): Hazard Ratio\>1.|Wald chi-square test||Hazard ratios, 90% CIs and associated Wald Chi-square p-values between TAK-954 dose levels and placebo are obtained using a stratified Cox proportional hazard model with treatment as the only independent variable.|||1.49|0.73|=0.422
72353309|NCT02552966|144226762|OTHER|||||||0.61|||||||t-test, 2 sided|This t-test was applied to determine if the mean salivary pepsin concentration changed between baseline and 2 week post UESAD measurements.||||||0.61
72353310|NCT02552966|144226763|OTHER||||||<|0.01|||||||t-test, 2 sided|||||||<0.01
72353311|NCT02552966|144226764|OTHER||||||<|0.01|||||||t-test, 2 sided|||||||<0.01
72353312|NCT02552966|144226765|OTHER||||||<|0.01|||||||t-test, 2 sided|||||||<0.01
72353313|NCT01721161|144226778|SUPERIORITY_OR_OTHER||Difference|-3.48||||0.3337|TWO_SIDED|95.0|-10.61|3.65|||ANCOVA||Difference is calculated as BIIB033 100 mg/kg - placebo.|||3.65|-10.61|0.3337
72353314|NCT01721161|144226779|SUPERIORITY_OR_OTHER||Difference|-3.89||||0.1868|TWO_SIDED|95.0|-9.7|1.92|||ANCOVA||Difference is calculated as BIIB033 100 mg/kg - placebo.|||1.92|-9.70|0.1868
72353315|NCT01721161|144226780|SUPERIORITY_OR_OTHER||Difference|-4.76||||0.1488|TWO_SIDED|95.0|-11.26|1.74|||ANCOVA|||||1.74|-11.26|0.1488
72353316|NCT01721161|144226781|SUPERIORITY_OR_OTHER||Difference|-1.15||||0.4975|TWO_SIDED|95.0|-4.51|2.21|||ANCOVA||Difference is calculated as BIIB033 100 mg/kg - placebo.|||2.21|-4.51|0.4975
72353317|NCT01721161|144226782|SUPERIORITY_OR_OTHER||Difference|-1.76||||0.3505|TWO_SIDED|95.0|-5.5|1.98|||ANCOVA|||||1.98|-5.50|0.3505
72353318|NCT01721161|144226783|SUPERIORITY_OR_OTHER||Difference|-1.6||||0.5371|TWO_SIDED|95.0|-6.9|3.6|||ANCOVA||Difference is calculated as BIIB033 100 mg/kg - placebo.|LCLA 1.25% chart||3.6|-6.9|0.5371
72353319|NCT01721161|144226783|SUPERIORITY_OR_OTHER||Difference|-0.8||||0.7741|TWO_SIDED|95.0|-6.5|4.9|||ANCOVA||Difference is calculated as BIIB033 100 mg/kg - placebo.|LCLA 2.5% chart||4.9|-6.5|0.7741
72353320|NCT01721161|144226784|SUPERIORITY_OR_OTHER||Difference|-1.2||||0.6645|TWO_SIDED|95.0|-6.6|4.3|||ANCOVA|||LCLA 1.25% chart||4.3|-6.6|0.6645
72353321|NCT01721161|144226784|SUPERIORITY_OR_OTHER||DIfference|-0.8||||0.8015|TWO_SIDED|95.0|-6.7|5.2|||ANCOVA|||LCLA 2.5%||5.2|-6.7|0.8015
72353322|NCT01721161|144226785|SUPERIORITY_OR_OTHER||Difference|-7.55||||0.0504|TWO_SIDED|95.0|-15.12|0.01|||ANCOVA|||||0.01|-15.12|0.0504
72353323|NCT00614380|144226797|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.34||||||95.0|0.22|0.53|||Cochran-Mantel-Haenszel|||||0.53|0.22|
72353324|NCT00614380|144226797|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.31||||||95.0|0.12|0.81|||Cochran-Mantel-Haenszel|||||0.81|0.12|
72353325|NCT00614380|144226797|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.08||||||95.0|0.06|0.13|||Cochran-Mantel-Haenszel|||||0.13|0.06|
72353326|NCT00614380|144226797|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.91||||||95.0|0.34|2.41|||Cochran-Mantel-Haenszel|||||2.41|0.34|
72353327|NCT00614380|144226797|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.25||||||95.0|0.16|0.39|||Cochran-Mantel-Haenszel|||||0.39|0.16|
72353328|NCT00614380|144226797|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.27||||||95.0|0.1|0.72|||Cochran-Mantel-Haenszel|||||0.72|0.10|
72353329|NCT03483896|144226811|SUPERIORITY||Mean Difference (Final Values)|-3.5||||0.01|TWO_SIDED||||||Mixed Models Analysis|||||||0.01
72353330|NCT03483896|144226812|SUPERIORITY||Mean Difference (Final Values)|-6.0||||0.17|TWO_SIDED||||||Mixed Models Analysis|||||||0.17
72353331|NCT02888106|144226813|SUPERIORITY|||||||0.0022|||||||Fisher Exact|||The proportions of negative HDV RNA response at week 72 in each of the MXB treatment groups were compared with the control group of PEG-IFNα by using Fisher's exact test and by presenting exact unconditional 95%-confidence intervals (CI) based on scores for the proportion differences.||||0.0022
72353332|NCT02888106|144226813|SUPERIORITY|||||||0.0996|||||||Fisher Exact|||||||0.0996
72353333|NCT02888106|144226813|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.0000
72353334|NCT02888106|144226813|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.0000
72353335|NCT02888106|144226813|SUPERIORITY|||||||0.0421|||||||Fisher Exact|||||||0.0421
72353336|NCT02888106|144226814|SUPERIORITY|||||||0.0052|||||||Fisher Exact|||Week 24||||0.0052
72353337|NCT02888106|144226814|SUPERIORITY|||||||0.0052|||||||Fisher Exact|||Week 24||||0.0052
72353338|NCT02888106|144226814|SUPERIORITY|||||||1|||||||Fisher Exact|||Week 24||||1.0000
72353339|NCT02888106|144226814|SUPERIORITY|||||||0.0017|||||||Fisher Exact|||Week 24||||0.0017
72353340|NCT02888106|144226814|SUPERIORITY|||||||0.3295|||||||Fisher Exact|||Week 24||||0.3295
72353341|NCT02888106|144226814|SUPERIORITY|||||||0.0007|||||||Fisher Exact|||Week 48||||0.0007
72353342|NCT02888106|144226814|SUPERIORITY|||||||0.0001|||||||Fisher Exact|||Week 48||||0.0001
72353343|NCT02888106|144226814|SUPERIORITY|||||||1|||||||Fisher Exact|||Week 48||||1.0000
72353344|NCT02888106|144226814|SUPERIORITY|||||||0.0007|||||||Fisher Exact|||Week 48||||0.0007
72353345|NCT02888106|144226814|SUPERIORITY|||||||0.1086|||||||Fisher Exact|||Week 48||||0.1086
72353346|NCT02888106|144226815|SUPERIORITY|||||||1|||||||Fisher Exact|||Week 24||||1.0000
72353347|NCT02888106|144226815|SUPERIORITY|||||||0.2241|||||||Fisher Exact|||Week 24||||0.2241
72353348|NCT02888106|144226815|SUPERIORITY|||||||0.0002|||||||Fisher Exact|||Week 24||||0.0002
72353349|NCT02888106|144226815|SUPERIORITY|||||||0.2241|||||||Fisher Exact|||Week 24||||0.2241
72353350|NCT02888106|144226815|SUPERIORITY|||||||0.0007|||||||Fisher Exact|||Week 24||||0.0007
72353351|NCT02888106|144226815|SUPERIORITY|||||||1|||||||Fisher Exact|||Week 48||||1.0000
72353352|NCT02888106|144226815|SUPERIORITY|||||||0.4497|||||||Fisher Exact|||Week 48||||0.4497
72353353|NCT02888106|144226815|SUPERIORITY|||||||0.0268|||||||Fisher Exact|||Week 48||||0.0268
72353354|NCT02888106|144226815|SUPERIORITY|||||||1|||||||Fisher Exact|||Week 48||||1.0000
72353355|NCT02888106|144226815|SUPERIORITY|||||||0.6999|||||||Fisher Exact|||Week 48||||0.6999
72353356|NCT02888106|144226815|SUPERIORITY|||||||0.0743|||||||Fisher Exact|||Week 72||||0.0743
72353357|NCT02888106|144226815|SUPERIORITY|||||||0.3449|||||||t-test, 1 sided|||Week 72||||0.3449
72353358|NCT02888106|144226815|SUPERIORITY|||||||0.6036|||||||Fisher Exact|||Week 72||||0.6036
72353359|NCT02888106|144226815|SUPERIORITY|||||||0.3408|||||||Fisher Exact|||Week 72||||0.3408
72353360|NCT02888106|144226815|SUPERIORITY|||||||0.3408|||||||Fisher Exact|||Week 72||||0.3408
72353361|NCT02888106|144226816|SUPERIORITY|||||||1|||||||Fisher Exact|||Week 24||||1.0000
72353362|NCT02888106|144226816|SUPERIORITY|||||||0.2241|||||||Fisher Exact|||Week 24||||0.2241
72353363|NCT02888106|144226816|SUPERIORITY|||||||0.4828|||||||Fisher Exact|||Week 24||||0.4828
72353364|NCT02888106|144226816|SUPERIORITY|||||||0.4828|||||||Fisher Exact|||Week 24||||0.4828
72353365|NCT02888106|144226816|SUPERIORITY|||||||0.4828|||||||Fisher Exact|||Week 24||||0.4828
72353366|NCT02888106|144226816|SUPERIORITY|||||||0.5977|||||||Fisher Exact|||Week 48||||0.5977
72353367|NCT02888106|144226816|SUPERIORITY|||||||0.1686|||||||Fisher Exact|||Week 48||||0.1686
72353368|NCT02888106|144226816|SUPERIORITY|||||||1|||||||Fisher Exact|||Week 48||||1.0000
72353369|NCT02888106|144226816|SUPERIORITY|||||||0.5977|||||||Fisher Exact|||Week 48||||0.5977
72353370|NCT02888106|144226816|SUPERIORITY|||||||1|||||||Fisher Exact|||Week 48||||1.0000
72353371|NCT02888106|144226816|SUPERIORITY|||||||0.0063|||||||Fisher Exact|||Week 72||||0.0063
72353372|NCT02888106|144226816|SUPERIORITY|||||||0.4828|||||||Fisher Exact|||Week 72||||0.4828
72353373|NCT02888106|144226816|SUPERIORITY|||||||1|||||||Fisher Exact|||Week 72||||1.0000
72353374|NCT02888106|144226816|SUPERIORITY|||||||1|||||||Fisher Exact|||Week 72||||1.0000
72353375|NCT02888106|144226816|SUPERIORITY|||||||0.4828|||||||Fisher Exact|||Week 72||||0.4828
72353376|NCT02888106|144226817|SUPERIORITY|||||||0.0801|||||||Fisher Exact|||Week 24||||0.0801
72353377|NCT02888106|144226817|SUPERIORITY|||||||1|||||||Fisher Exact|||Week 24||||1.0000
72353378|NCT02888106|144226817|SUPERIORITY|||||||1|||||||Fisher Exact|||Week 24||||1.0000
72353379|NCT02888106|144226817|SUPERIORITY|||||||1|||||||Fisher Exact|||Week 24||||1.0000
72353380|NCT02888106|144226817|SUPERIORITY|||||||1|||||||Fisher Exact|||Week 24||||1.0000
72353381|NCT02888106|144226817|SUPERIORITY|||||||0.0063|||||||Fisher Exact|||Week 48||||0.0063
72353382|NCT02888106|144226817|SUPERIORITY|||||||0.2241|||||||Fisher Exact|||Week 48||||0.2241
72353383|NCT02888106|144226817|SUPERIORITY|||||||1|||||||Fisher Exact|||Week 48||||1.0000
72353384|NCT02888106|144226817|SUPERIORITY|||||||0.0169|||||||Regression, Cox|||Week 72||||0.0169
72353385|NCT02888106|144226817|SUPERIORITY|||||||0.4828|||||||Fisher Exact|||Week 72||||0.4828
72353386|NCT02888106|144226817|SUPERIORITY|||||||0.4828|||||||Fisher Exact|||Week 72||||0.4828
72353387|NCT02888106|144226818|SUPERIORITY|||||||0.4828|||||||Fisher Exact|||Week 48||||0.4828
72353388|NCT02888106|144226818|SUPERIORITY|||||||1|||||||Fisher Exact|||Week 48||||1.0000
72353389|NCT02888106|144226818|SUPERIORITY|||||||0.2292|||||||Fisher Exact|||Week 72||||0.2292
72353390|NCT02888106|144226818|SUPERIORITY|||||||1|||||||Fisher Exact|||Week 72||||1.0000
72353391|NCT02888106|144226819|SUPERIORITY|||||||0.4621|||||||Fisher Exact|||Week 24||||0.4621
72353392|NCT02888106|144226819|SUPERIORITY|||||||1|||||||Chi-squared, Corrected|||Week 24||||1.0000
72353393|NCT02888106|144226819|SUPERIORITY|||||||1|||||||Fisher Exact|||Week 24||||1.0000
72353394|NCT02888106|144226819|SUPERIORITY|||||||0.4621|||||||Fisher Exact|||Week 24||||0.4621
72353395|NCT02888106|144226819|SUPERIORITY|||||||0.0253|||||||Fisher Exact|||Week 24||||0.0253
72353396|NCT02888106|144226819|SUPERIORITY|||||||0.0268|||||||Fisher Exact|||Week 48||||0.0268
72353397|NCT02888106|144226819|SUPERIORITY|||||||0.6999|||||||Fisher Exact|||Week 48||||0.6999
72353398|NCT02888106|144226819|SUPERIORITY|||||||1|||||||Fisher Exact|||Week 48||||1.0000
72353399|NCT02888106|144226819|SUPERIORITY|||||||0.0656|||||||Fisher Exact|||Week 48||||0.0656
72353400|NCT02888106|144226819|SUPERIORITY|||||||0.0005|||||||Fisher Exact|||Week 48||||0.0005
72353401|NCT02888106|144226819|SUPERIORITY|||||||0.1431|||||||Fisher Exact|||Week 72||||0.1431
72353402|NCT02888106|144226819|SUPERIORITY|||||||1|||||||Fisher Exact|||Week 72||||1.0000
72353403|NCT02888106|144226819|SUPERIORITY|||||||1|||||||Fisher Exact|||Week 72||||1.0000
72353404|NCT02888106|144226819|SUPERIORITY|||||||1|||||||Fisher Exact|||Week 72||||1.0000
72353405|NCT02888106|144226819|SUPERIORITY|||||||0.7104|||||||Fisher Exact|||Week 72||||0.7104
72353406|NCT03865446|144226873|OTHER||Geometric Means Ratio|130.91|||||TWO_SIDED|90.0|86.03|199.22|||||The model was an analysis of variance (ANOVA) model with unequal variance assumption and hepatic impairment group as fixed effect. Values were back-transformed from the log scale.|||199.22|86.03|
72353407|NCT03865446|144226874|OTHER||Geometric Means Ratio|104.41|||||TWO_SIDED|90.0|72.12|151.16|||||The model was an ANOVA model with unequal variance assumption and hepatic impairment group as fixed effect. Values are back-transformed from the log scale.|||151.16|72.12|
72353408|NCT01708317|144226914|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.0|||<|0.001||||||We used a cutoff of P\<0.05 as statistically significant.|Chi-squared|3 degrees of freedom to compare 4 time periods.||We compared testing in the 4 time frames described, including the time frame in which we enrolled patients in the ACASI.||||<.001
72353409|NCT03259555|144226921|SUPERIORITY||Treatment difference|0.14|||=|0.8797|TWO_SIDED|95.0|-1.74|2.03|||Mixed-effect Model Repeated Measure|"An unstructured covariance was used."|"Comparison between treatment groups was carried out using MMRM, with study center, treatment group, visit, and treatment group-by-visit interaction as factor and baseline-by-visit interaction as a covariate. An unstructured covariance was used."|||2.03|-1.74|=0.8797
72353410|NCT04970654|144226985|NON_INFERIORITY|Non-inferiority was considered confirmed if the lower bound of the 95% confidence interval was higher than the margin of -2.0 cm/year.|Treatment difference|0.6|||||TWO_SIDED|95.0|-0.2|1.3||||||Hypothetical strategy estimand. Height velocity at 52 weeks was analyzed using a mixed model for repeated measurements, with treatment, gender, age group, growth hormone (GH) peak group and gender by age group interaction term as factors and baseline height as a covariate, all nested within week as a factor.||1.3|-0.2|
72353411|NCT06172348|144227002|OTHER||Ratio of Adjusted Geometric Means|21.89|||||TWO_SIDED|90.0|19.31|24.8|||||Ratios (Test/Reference) and 90 percent (%) confidence intervals were expressed as percentages. Test = MR1 capsule; Reference = Oral solution.|A mixed effect model was used with sequence, period and treatment as fixed effects and participant with sequence as a random effect.||24.80|19.31|
72353412|NCT06172348|144227002|OTHER||Ratio of Adjusted Geometric Means|12.65|||||TWO_SIDED|90.0|11.21|14.27|||||Ratios (Test/Reference) and 90% confidence intervals were expressed as percentages. Test = MR2 capsule; Reference = Oral solution.|A mixed effect model was used with sequence, period and treatment as fixed effects and participant with sequence as a random effect.||14.27|11.21|
72353413|NCT06172348|144227003|OTHER||Ratio of Adjusted Geometric Means|86.49|||||TWO_SIDED|90.0|79.11|94.54|||||Ratios (Test/Reference) and 90% confidence intervals were expressed as percentages. Test = MR1 capsule; Reference = Oral solution.|A mixed effect model was used with sequence, period and treatment as fixed effects and participant with sequence as a random effect.||94.54|79.11|
72353414|NCT06172348|144227003|OTHER||Ratio of Adjusted Geometric Means|76.99|||||TWO_SIDED|90.0|70.65|83.9|||||Ratios (Test/Reference) and 90% confidence intervals were expressed as percentages. Test = MR2 capsule; Reference = Oral solution.|A mixed effect model was used with sequence, period and treatment as fixed effects and participant with sequence as a random effect.||83.90|70.65|
72353415|NCT06172348|144227004|OTHER||Ratio of Adjusted Geometric Means|123.92|||||TWO_SIDED|90.0|105.16|146.02|||||Ratios (Test/Reference) and 90% confidence intervals were expressed as percentages. Test = MR1 capsule (fed); Reference = MR1 capsule (fasted).|A mixed effect model was used with sequence, period and treatment as fixed effects and participant with sequence as a random effect.||146.02|105.16|
72353416|NCT06172348|144227004|OTHER||Ratio of Adjusted Geometric Means|129.79|||||TWO_SIDED|90.0|111.51|151.06|||||Ratios (Test/Reference) and 90% confidence intervals were expressed as percentages. Test = MR2 capsule (fed); Reference = MR2 capsule (fasted).|A mixed effect model was used with sequence, period and treatment as fixed effects and participant with sequence as a random effect.||151.06|111.51|
72353417|NCT06172348|144227005|OTHER||Ratio of Adjusted Geometric Means|107.48|||||TWO_SIDED|90.0|96.46|119.76|||||Ratios (Test/Reference) and 90% confidence intervals were expressed as percentages. Test = MR1 capsule (fed); Reference = MR1 capsule (fasted).|A mixed effect model was used with sequence, period and treatment as fixed effects and participant with sequence as a random effect.||119.76|96.46|
72353418|NCT06172348|144227005|OTHER||Ratio of Adjusted Geometric Means|109.63|||||TWO_SIDED|90.0|99.19|121.17|||||Ratios (Test/Reference) and 90% confidence intervals were expressed as percentages. Test = MR2 capsule (fed); Reference = MR2 capsule (fasted).|A mixed effect model was used with sequence, period and treatment as fixed effects and participant with sequence as a random effect.||121.17|99.19|
72353419|NCT05579977|144227063|OTHER||LS Mean Difference|-0.95|||<|0.0001|TWO_SIDED|90.0|-1.2|-0.7|||Mixed Models Analysis|||||-0.70|-1.20|<.0001
72353420|NCT05579977|144227063|OTHER||LS Mean Difference|-1.3|||<|0.0001|TWO_SIDED|90.0|-1.55|-1.04|||Mixed Models Analysis|||||-1.04|-1.55|<.0001
72353421|NCT05579977|144227063|OTHER||LS Mean Difference|-1.37|||<|0.0001||90.0|-1.62|-1.11|||Mixed Models Analysis|||||-1.11|-1.62|<.0001
72353422|NCT05579977|144227063|OTHER||LS Mean Difference|-1.26|||<|0.0001|TWO_SIDED|90.0|-1.52|-1.01|||Mixed Models Analysis|||||-1.01|-1.52|<.0001
72353423|NCT05579977|144227063|OTHER||LS Mean Difference|-1.29|||<|0.0001||90.0|-1.55|-1.03|||Mixed Models Analysis|||||-1.03|-1.55|<.0001
72353424|NCT05579977|144227063|OTHER||LS Mean Difference|-0.86|||<|0.0001|TWO_SIDED|90.0|-1.12|-0.61|||Mixed Models Analysis|||||-0.61|-1.12|<.0001
72353425|NCT05579977|144227064|OTHER||LS Mean Difference|-2.44||||0.0055|TWO_SIDED|90.0|-3.88|-1.0|||Mixed Models Analysis|||||-1.00|-3.88|0.0055
72353426|NCT05579977|144227064|OTHER||LS Mean Difference|-4.37|||<|0.0001|TWO_SIDED|90.0|-5.84|-2.89|||Mixed Models Analysis|||||-2.89|-5.84|<.0001
72369525|NCT03532451|144249274|SUPERIORITY|||||||0.002|||||||Wilcoxon Signed-Rank Test|||||||0.002
72353427|NCT05579977|144227064|OTHER||LS Mean Difference|-5.63|||<|0.0001|TWO_SIDED|90.0|-7.07|-4.18|||Mixed Models Analysis|||||-4.18|-7.07|<.0001
72353428|NCT05579977|144227064|OTHER||LS Mean Difference|-5.04|||<|0.0001|TWO_SIDED|90.0|-6.5|-3.58|||Mixed Models Analysis|||||-3.58|-6.50|<.0001
72353429|NCT05579977|144227064|OTHER||LS Mean Difference|-5.42|||<|0.0001|TWO_SIDED|90.0|-6.91|-3.93|||Mixed Models Analysis|||||-3.93|-6.91|<.0001
72353430|NCT05579977|144227067|OTHER||LS Mean Difference|-0.86|||<|0.0001|TWO_SIDED|90.0|-1.12|-0.61|||Mixed Models Analysis|||||-0.61|-1.12|<.0001
72353431|NCT03628976|144227072|SUPERIORITY|||||||0.0096|||||||ANOVA|||||||0.0096
72353432|NCT03628976|144227073|SUPERIORITY|||||||0.764|||||||ANOVA|||||||0.764
72353433|NCT03628976|144227074|SUPERIORITY|||||||0.446|||||||ANOVA|||||||0.446
72353434|NCT01420926|144227077|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3|||||||Stratified 1-sided log-rank|||||||0.30
72353435|NCT00932321|144227083|NON_INFERIORITY_OR_EQUIVALENCE|Primary hypothesis tested was the independence (lack of association) of mean number of IB days in Cycles 2-6 across treatment groups.||||||0.311|||||||Cochran-Mantel-Haenszel|Stratified by investigational site.||||||0.311
72353436|NCT02775916|144227085|SUPERIORITY||Mean Difference (Net)|-0.69|STANDARD_DEVIATION|1.332|||TWO_SIDED|95.0|-3.343|1.937||||||||1.937|-3.343|
72353437|NCT02775916|144227086|SUPERIORITY||Mean Difference (Net)|0.51|STANDARD_ERROR_OF_MEAN|1.466|||TWO_SIDED|95.0|-2.52|3.55||||||||3.55|-2.52|
72353438|NCT02775916|144227087|SUPERIORITY||Mean Difference (Net)|0.4|STANDARD_ERROR_OF_MEAN|3.119|||TWO_SIDED|95.0|-6.08|6.89||||||||6.89|-6.08|
72353439|NCT02775916|144227087|SUPERIORITY||Mean Difference (Net)|4.33|STANDARD_ERROR_OF_MEAN|4.615|||TWO_SIDED|95.0|-5.27|13.93||||||||13.93|-5.27|
72353440|NCT02775916|144227088|SUPERIORITY||Mean Difference (Net)|-6.55|STANDARD_ERROR_OF_MEAN|7.27|||TWO_SIDED|95.0|-21.76|8.66||||||||8.66|-21.76|
72353441|NCT02775916|144227089|SUPERIORITY||Mean Difference (Net)|-10.97|STANDARD_ERROR_OF_MEAN|9.626|||TWO_SIDED|95.0|-30.94|9.0||||||||9.00|-30.94|
72353442|NCT02775916|144227090|SUPERIORITY||Mean Difference (Net)|-7.69|STANDARD_ERROR_OF_MEAN|10.595|||TWO_SIDED|95.0|-29.75|14.37||||||||14.37|-29.75|
72353443|NCT00865345|144227099|SUPERIORITY_OR_OTHER||Intercept from ANCOVA model|70.0|STANDARD_ERROR_OF_MEAN|2.0|<|0.05|TWO_SIDED|95.0|60.0|100.0|||ANCOVA|null model ANOVA is used to calculate 95% CI around accuracy rate. Intercept was fit in the abscence of other predictors.||||100|60|<0.05
72353444|NCT02723773|144227112|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|79.77|||||TWO_SIDED|95.0|73.72|84.61|||Poisson regression method||VE=1 - the relative risk (RR). RR=the ratio of the incidence rates of LTFU+Control \>=50YOA Group over Historical Control \>=50YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between LTFU+Control \>=50 YOA Group and Historical Control \>=50 YOA Group.||84.61|73.72|
72353445|NCT02723773|144227113|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|86.67|||||TWO_SIDED|95.0|75.55|93.36|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of LTFU+Control 50-59 YOA Group over Historical Control 50-59 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between LTFU+Control 50-59 YOA Group and Historical Control 50-59 YOA Group.||93.36|75.55|
72353446|NCT02723773|144227113|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|87.14|||||TWO_SIDED|95.0|74.17|94.35|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of LTFU+Control 60-69 YOA Group over Historical Control 60-69 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between LTFU+Control 60-69 YOA Group and Historical Control 60-69 YOA Group.||94.35|74.17|
72353447|NCT02723773|144227113|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|77.11|||||TWO_SIDED|95.0|69.37|83.14|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of LTFU+Control \>=60 YOA Group over Historical Control \>=60 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between LTFU+Control \>=60 YOA Group and Historical Control \>=60 YOA Group.||83.14|69.37|
72353448|NCT02723773|144227113|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|73.18|||||TWO_SIDED|95.0|62.94|80.92|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of LTFU+Control \>=70 YOA Group over Historical Control \>=70 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between LTFU+Control \>=70 YOA Group and Historical Control \>=70 YOA Group.||80.92|62.94|
72353449|NCT02723773|144227114|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|87.73|||||TWO_SIDED|95.0|84.89|90.12|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su \>=50 YOA Group over Placebo/Historical Control \>=50 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su \>=50 YOA Group and Placebo/Historical Control 50 YOA Group.||90.12|84.89|
72369526|NCT03532451|144249275|SUPERIORITY|||||||0.88|||||||Wilcoxon rank sum test|||||||0.88
72369527|NCT02685267|144249332|OTHER|The study was terminated after only 9 patients enrolled, 5 to the standard of care docetaxel/prednisone arm and 4 to experimental docetaxel/prednisone/enzalutamide arm.|log-rank test|0.6761||||0.6761|TWO_SIDED|95.0|||||Chi-squared|||The study was terminated after only 9 patients enrolled, 5 to the standard of care docetaxel/prednisone arm and 4 to experimental docetaxel/prednisone/enzalutamide arm.||||0.6761
72353450|NCT02723773|144227114|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|91.74|||||TWO_SIDED|95.0|86.25|95.37|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su 50-59 YOA Group over Placebo/Historical Control 50-59 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy in prevention of HZ between HZ/su 50-59 YOA Group and Placebo/Historical Control 50-59 YOA Group.||95.37|86.25|
72353451|NCT02723773|144227114|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|92.57|||||TWO_SIDED|95.0|86.66|96.24|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su 60-69 YOA Group over Placebo/Historical Control 60-69 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy in prevention of HZ between HZ/su 60-69 YOA Group and Placebo/Historical Control 60-69 YOA Group.||96.24|86.66|
72353452|NCT02723773|144227114|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|86.45|||||TWO_SIDED|95.0|82.98|89.33|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su \>=60 YOA Group over Placebo/Historical Control \>=60 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy in prevention of HZ between HZ/su \>=60 YOA Group and Placebo/Historical Control \>=60 YOA Group.||89.33|82.98|
72353453|NCT02723773|144227114|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|84.33|||||TWO_SIDED|95.0|79.91|87.93|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su \>=70 YOA Group over Placebo/Historical Control \>=70 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy in prevention of HZ between HZ/su \>=70 YOA Group and Placebo/Historical Control \>=70 YOA Group.||87.93|79.91|
72353454|NCT02723773|144227115|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|97.68|||||TWO_SIDED|95.0|93.07|99.53|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su \>=50 YOA Group over Placebo/Historical Control \>=50 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su \>=50 YOA Group and Placebo/Historical Control \>=50 YOA Group over Year 1.||99.53|93.07|
72353455|NCT02723773|144227115|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|96.76|||||TWO_SIDED|95.0|80.57|99.92|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su 50-59 YOA Group over Placebo/Historical Control 50-59 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su 50-59 YOA Group and Placebo/Historical Control 50-59 YOA Group over Year 1.||99.92|80.57|
72353456|NCT02723773|144227115|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|100.0|||||TWO_SIDED|95.0|79.32|100.0|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su 60-69 YOA Group over Placebo/Historical Control 60-69 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su 60-69 YOA Group and Placebo/Historical Control 60-69 YOA Group over Year 1.||100.00|79.32|
72353457|NCT02723773|144227115|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|97.97|||||TWO_SIDED|95.0|92.46|99.76|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su \>=60 YOA Group over Placebo/Historical Control \>=60 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su \>=60 YOA Group and Placebo/Historical Control \>=60 YOA Group over Year 1.||99.76|92.46|
72429205|NCT01058863|144369414|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.08|STANDARD_ERROR_OF_MEAN|0.136|<|0.0001|TWO_SIDED|95.0|0.81|1.35||Significance at the 0.05 level.|ANOVA|Fixed effects of baseline FEV1 as a covariate, sequence, treatment group, period, and center, and random effect for subject within sequence.||Of interest was the mean difference between each active group and placebo at each dose level. Analyses were performed at the 2-sided 0.05 significance level in this sequence: Albuterol Spiromax 180 mcg versus placebo; Albuterol Spiromax 90 mcg versus placebo, ProAir HFA 180 mcg versus placebo, and ProAir HFA 90 mcg versus placebo. If a test was not significant, no further tests were done. This sequential procedure preserved the error rate for the family of tests at the 0.05 level..||1.35|0.81|<0.0001
72353458|NCT02723773|144227115|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|97.57|||||TWO_SIDED|95.0|90.96|99.71|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su \>=70 YOA Group over Placebo/Historical Control \>=70 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su \>=70 YOA Group and Placebo/Historical Control \>=70 YOA Group over Year 1.||99.71|90.96|
72353459|NCT02723773|144227115|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|92.69|||||TWO_SIDED|95.0|86.15|96.57|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su \>=50 YOA Group over Placebo/Historical Control \>=50 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su \>=50 YOA Group and Placebo/Historical Control \>=50 YOA Group over Year 2.||96.57|86.15|
72353460|NCT02723773|144227115|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|92.66|||||TWO_SIDED|95.0|70.78|99.15|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su 50-59 YOA Group over Placebo/Historical Control 50-59 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su 50-59 YOA Group and Placebo/Historical Control 50-59 YOA Group over Year 2.||99.15|70.78|
72353461|NCT02723773|144227115|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|95.49|||||TWO_SIDED|95.0|72.11|99.89|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su 60-69 YOA Group over Placebo/Historical Control 60-69 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su 60-69 YOA Group and Placebo/Historical Control 60-69 YOA Group over Year 2.||99.89|72.11|
72353462|NCT02723773|144227115|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|92.71|||||TWO_SIDED|95.0|85.13|96.93|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su \>=60 YOA Group over Placebo/Historical Control \>=60 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su \>=60 YOA Group and Placebo/Historical Control \>=60 YOA Group over Year 2.||96.93|85.13|
72353463|NCT02723773|144227115|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|92.01|||||TWO_SIDED|95.0|82.82|96.88|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su \>=70 YOA Group over Placebo/Historical Control \>=70 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su \>=70 YOA Group and Placebo/Historical Control \>=70 YOA Group over Year 2.||96.88|82.82|
72353464|NCT02723773|144227115|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|92.36|||||TWO_SIDED|95.0|84.98|96.59|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su \>=50 YOA Group over Placebo/Historical Control \>=50 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su \>=50 YOA Group and Placebo/Historical Control \>=50 YOA Group over Year 3.||96.59|84.98|
72353465|NCT02723773|144227115|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|100.0|||||TWO_SIDED|95.0|89.2|100.0|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su 50-59 YOA Group over Placebo/Historical Control 50-59 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su 50-59 YOA Group and Placebo/Historical Control 50-59 YOA Group over Year 3.||100.00|89.20|
72353466|NCT02723773|144227115|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|100.0|||||TWO_SIDED|95.0|89.39|100.0|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su 60-69 YOA Group over Placebo/Historical Control 60-69 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su 60-69 YOA Group and Placebo/Historical Control 60-69 YOA Group over Year 3.||100.00|89.39|
72353467|NCT02723773|144227115|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|89.84|||||TWO_SIDED|95.0|79.81|95.51|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su \>=60 YOA Group over Placebo/Historical Control \>=60 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su \>=60 YOA Group and Placebo/Historical Control \>=60 YOA Group over Year 3.||95.51|79.81|
72429206|NCT01058863|144369414|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.88|STANDARD_ERROR_OF_MEAN|0.136|<|0.0001|TWO_SIDED|95.0|0.61|1.15||Significance at the 0.05 level.|ANOVA|Fixed effects of baseline FEV1 as a covariate, sequence, treatment group, period, and center, and random effect for subject within sequence.||Of interest was the mean difference between each active group and placebo at each dose level. Analyses were performed at the 2-sided 0.05 significance level in this sequence: Albuterol Spiromax 180 mcg versus placebo; Albuterol Spiromax 90 mcg versus placebo, ProAir HFA 180 mcg versus placebo, and ProAir HFA 90 mcg versus placebo. If a test was not significant, no further tests were done. This sequential procedure preserved the error rate for the family of tests at the 0.05 level.||1.15|0.61|<0.0001
72353468|NCT02723773|144227115|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|84.74|||||TWO_SIDED|95.0|68.99|93.35|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su \>=70 YOA Group over Placebo/Historical Control \>=70 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su \>=70 YOA Group and Placebo/Historical Control \>=70 YOA Group over Year 3.||93.35|68.99|
72353469|NCT02723773|144227115|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|89.75|||||TWO_SIDED|95.0|80.31|95.24|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su \>=50 YOA Group over Placebo/Historical Control \>=50 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su \>=50 YOA Group and Placebo/Historical Control \>=50 YOA Group over Year 4.||95.24|80.31|
72353470|NCT02723773|144227115|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|93.88|||||TWO_SIDED|95.0|60.62|99.85|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su 50-59 YOA Group over Placebo/Historical Control 50-59 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su 50-59 YOA Group and Placebo/Historical Control 50-59 YOA Group over Year 4.||99.85|60.62|
72353471|NCT02723773|144227115|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|91.62|||||TWO_SIDED|95.0|66.1|99.04|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su 60-69 YOA Group over Placebo/Historical Control 60-69 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su 60-69 YOA Group and Placebo/Historical Control 60-69 YOA Group over Year 4.||99.04|66.10|
72353472|NCT02723773|144227115|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|88.96|||||TWO_SIDED|95.0|77.96|95.13|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su \>=60 YOA Group over Placebo/Historical Control \>=60 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su \>=60 YOA Group and Placebo/Historical Control \>=60 YOA Group over Year 4.||95.13|77.96|
72353473|NCT02723773|144227115|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|87.86|||||TWO_SIDED|95.0|73.3|95.33|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su \>=70 YOA Group over Placebo/Historical Control \>=70 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su \>=70 YOA Group and Placebo/Historical Control \>=70 YOA Group over Year 4.||95.33|73.30|
72353474|NCT02723773|144227115|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|83.87|||||TWO_SIDED|95.0|68.31|92.63|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su \>=50 YOA Group over Placebo/Historical Control \>=50 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su \>=50 YOA Group and Placebo/Historical Control \>=50 YOA Group over Year 6.||92.63|68.31|
72353475|NCT02723773|144227115|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|87.5|||||TWO_SIDED|95.0|46.83|98.61|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su 50-59 YOA Group over Placebo/Historical Control 50-59 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su 50-59 YOA Group and Placebo/Historical Control 50-59 YOA Group over Year 6.||98.61|46.83|
72353476|NCT02723773|144227115|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|92.31|||||TWO_SIDED|95.0|48.79|99.82|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su 60-69 YOA Group over Placebo/Historical Control 60-69 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su 60-69 YOA Group and Placebo/Historical Control 60-69 YOA Group over Year 6.||99.82|48.79|
72353477|NCT02723773|144227115|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|82.98|||||TWO_SIDED|95.0|63.64|93.05|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su \>=60 YOA Group over Placebo/Historical Control \>=60 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su \>=60 YOA Group and Placebo/Historical Control \>=60 YOA Group over Year 6.||93.05|63.64|
72353478|NCT02723773|144227115|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|80.0|||||TWO_SIDED|95.0|54.3|92.5|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su \>=70 YOA Group over Placebo/Historical Control \>=70 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su \>=70 YOA Group and Placebo/Historical Control \>=70 YOA Group over Year 6.||92.50|54.30|
72353479|NCT02723773|144227115|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|83.61|||||TWO_SIDED|95.0|67.76|92.51|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su \>=50 YOA Group over Placebo/Historical Control \>=50 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su \>=50 YOA Group and Placebo/Historical Control \>=50 YOA Group over Year 7.||92.51|67.76|
72353480|NCT02723773|144227115|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|93.33|||||TWO_SIDED|95.0|56.67|99.84|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su 50-59 YOA Group over Placebo/Historical Control 50-59 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su 50-59 YOA Group and Placebo/Historical Control 50-59 YOA Group over Year 7.||99.84|56.67|
72353481|NCT02723773|144227115|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|84.62|||||TWO_SIDED|95.0|32.04|98.31|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su 60-69 YOA Group over Placebo/Historical Control 60-69 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su 60-69 YOA Group and Placebo/Historical Control 60-69 YOA Group over Year 7.||98.31|32.04|
72353482|NCT02723773|144227115|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|80.43|||||TWO_SIDED|95.0|59.54|91.58|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su \>=60 YOA Group over Placebo/Historical Control \>=60 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su \>=60 YOA Group and Placebo/Historical Control \>=60 YOA Group over Year 7.||91.58|59.54|
72353483|NCT02723773|144227115|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|78.79|||||TWO_SIDED|95.0|51.24|92.08|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su \>=70 YOA Group over Placebo/Historical Control \>=70 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su \>=70 YOA Group and Placebo/Historical Control \>=70 YOA Group over Year 7.||92.08|51.24|
72353484|NCT02723773|144227115|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|82.76|||||TWO_SIDED|95.0|65.98|92.14|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su \>=50 YOA Group over Placebo/Historical Control \>=50 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su \>=50 YOA Group and Placebo/Historical Control \>=50 YOA Group over Year 8.||92.14|65.98|
72353485|NCT02723773|144227115|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|86.67|||||TWO_SIDED|95.0|42.67|98.52|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su 50-59 YOA Group over Placebo/Historical Control 50-59 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su 50-59 YOA Group and Placebo/Historical Control 50-59 YOA Group over Year 8.||98.52|42.67|
72353486|NCT02723773|144227115|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|84.62|||||TWO_SIDED|95.0|32.04|98.31|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su 60-69 YOA Group over Placebo/Historical Control 60-69 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su 60-69 YOA Group and Placebo/Historical Control 60-69 YOA Group over Year 8.||98.31|32.04|
72353487|NCT02723773|144227115|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|81.4|||||TWO_SIDED|95.0|59.97|92.45|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su \>=60 YOA Group over Placebo/Historical Control \>=60 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su \>=60 YOA Group and Placebo/Historical Control \>=60 YOA Group over Year 8.||92.45|59.97|
72353488|NCT02723773|144227115|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|80.65|||||TWO_SIDED|95.0|52.91|93.4|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su \>=70 YOA Group over Placebo/Historical Control \>=70 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su \>=70 YOA Group and Placebo/Historical Control \>=70 YOA Group over Year 8.||93.40|52.91|
72353489|NCT02723773|144227115|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|73.68|||||TWO_SIDED|95.0|52.89|86.16|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su \>=50 YOA Group over Placebo/Historical Control \>=50 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su \>=50 YOA Group and Placebo/Historical Control \>=50 YOA Group over Year 9.||86.16|52.89|
72353490|NCT02723773|144227115|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|66.67|||||TWO_SIDED|95.0|3.52|90.52|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su 50-59 YOA Group over Placebo/Historical Control 50-59 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su 50-59 YOA Group and Placebo/Historical Control 50-59 YOA Group over Year 9.||90.52|3.52|
72353491|NCT02723773|144227115|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|72.73|||||TWO_SIDED|95.0|-3.24|95.11|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su 60-69 YOA Group over Placebo/Historical Control 60-69 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su 60-69 YOA Group and Placebo/Historical Control 60-69 YOA Group over Year 9.||95.11|-3.24|
72353492|NCT02723773|144227115|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|76.19|||||TWO_SIDED|95.0|51.78|89.35|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su \>=60 YOA Group over Placebo/Historical Control \>=60 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su \>=60 YOA Group and Placebo/Historical Control \>=60 YOA Group over Year 9.||89.35|51.78|
72353493|NCT02723773|144227115|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|75.86|||||TWO_SIDED|95.0|43.69|91.07|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su \>=70 YOA Group over Placebo/Historical Control \>=70 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su \>=70 YOA Group and Placebo/Historical Control \>=70 YOA Group over Year 9.||91.07|43.69|
72353494|NCT02723773|144227115|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|71.7|||||TWO_SIDED|95.0|49.03|85.18|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su \>=50 YOA Group over Placebo/Historical Control \>=50 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su \>=50 YOA Group and Placebo/Historical Control \>=50 YOA Group over Year 10.||85.18|49.03|
72353495|NCT02723773|144227115|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|100.0|||||TWO_SIDED|95.0|77.89|100.0|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su 50-59 YOA Group over Placebo/Historical Control 50-59 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su 50-59 YOA Group and Placebo/Historical Control 50-59 YOA Group over Year 10.||100.00|77.89|
72353496|NCT02723773|144227115|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|90.0|||||TWO_SIDED|95.0|29.71|99.77|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su 60-69 YOA Group over Placebo/Historical Control 60-69 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su 60-69 YOA Group and Placebo/Historical Control 60-69 YOA Group over Year 10.||99.77|29.71|
72353497|NCT02723773|144227115|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|60.53|||||TWO_SIDED|95.0|26.55|79.83|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su \>=60 YOA Group over Placebo/Historical Control \>=60 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su \>=60 YOA Group and Placebo/Historical Control \>=60 YOA Group over Year 10.||79.83|26.55|
72353498|NCT02723773|144227115|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|48.15|||||TWO_SIDED|95.0|-2.41|74.87|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su \>=70 YOA Group over Placebo/Historical Control \>=70 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su \>=70 YOA Group and Placebo/Historical Control \>=70 YOA Group over Year 10.||74.87|-2.41|
72353499|NCT02723773|144227115|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|82.0|||||TWO_SIDED|95.0|63.03|92.22|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su \>=50 YOA Group over Placebo/Historical Control \>=50 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su \>=50 YOA Group and Placebo/Historical Control \>=50 YOA Group over Year 11.||92.22|63.03|
72353500|NCT02723773|144227115|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|86.67|||||TWO_SIDED|95.0|42.67|98.52|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su 50-59 YOA Group over Placebo/Historical Control 50-59 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su 50-59 YOA Group and Placebo/Historical Control 50-59 YOA Group over Year 11.||98.52|42.67|
72353501|NCT02723773|144227115|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|100.0|||||TWO_SIDED|95.0|65.07|100.0|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su 60-69 YOA Group over Placebo/Historical Control 60-69 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su 60-69 YOA Group and Placebo/Historical Control 60-69 YOA Group over Year 11.||100.00|65.07|
72353502|NCT02723773|144227115|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|79.41|||||TWO_SIDED|95.0|52.82|92.3|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su \>=60 YOA Group over Placebo/Historical Control \>=60 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su \>=60 YOA Group and Placebo/Historical Control \>=60 YOA Group over Year 11.||92.30|52.82|
72353503|NCT02723773|144227115|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|72.0|||||TWO_SIDED|95.0|33.41|89.77|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su \>=70 YOA Group over Placebo/Historical Control \>=70 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su \>=70 YOA Group and Placebo/Historical Control \>=70 YOA Group over Year 11.||89.77|33.41|
72353504|NCT02723773|144227116|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|87.5|||||TWO_SIDED|95.0|64.75|96.79|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of LTFU+Control \>=50 YOA Group over Historical Control \>=50 YOA Group. The VE of HZ/su vaccine against PHN in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of PHN between LTFU+Control \>=50 YOA Group and Historical Control\>=50 YOA Group.||96.79|64.75|
72353505|NCT02723773|144227116|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|100.0|||||TWO_SIDED|95.0|46.59|100.0|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of LTFU+Control 50-59 YOA Group over Historical Control 50-59 YOA Group. The VE of HZ/su vaccine against PHN in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of PHN between LTFU+Control 50-59 YOA Group and Historical Control 50-59 YOA Group.||100.00|46.59|
72353506|NCT02723773|144227116|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|50.0|||||TWO_SIDED|95.0|-860.45|99.15|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of LTFU+Control 60-69 YOA Group over Historical Control 60-69 YOA Group. The VE of HZ/su vaccine against PHN in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of PHN between LTFU+Control 60-69 YOA Group and Historical Control 60-69 YOA Group.||99.15|-860.45|
72353507|NCT02723773|144227116|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|84.0|||||TWO_SIDED|95.0|53.66|95.95|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of LTFU+Control \>=60 YOA Group over Historical Control \>=60 YOA Group. The VE of HZ/su vaccine against PHN in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy in prevention of PHN between LTFU+Control \>=60 YOA Group and Historical Control \>=60 YOA Group.||95.95|53.66|
72353508|NCT02723773|144227116|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|86.96|||||TWO_SIDED|95.0|56.83|97.49|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of LTFU+Control \>=70 YOA Group over Historical Control \>=70 YOA Group. The VE of HZ/su vaccine against PHN in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy in prevention of PHN between LTFU+Control \>=70 YOA Group and Historical Control \>=70 YOA Group.||97.49|56.83|
72353509|NCT02723773|144227117|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|89.69|||||TWO_SIDED|95.0|78.67|95.7|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su \>=50 YOA Group over Placebo/Historical Control \>=50 YOA Group. The VE of HZ/su vaccine against PHN in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of PHN between HZ/su \>=50 YOA Group and Placebo/Historical Control \>=50 YOA Group.||95.70|78.67|
72353510|NCT02723773|144227117|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|100.0|||||TWO_SIDED|95.0|77.79|100.0|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su 50-59 YOA Group over Placebo/Historical Control 50-59 YOA Group. The VE of HZ/su vaccine against PHN in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of PHN between HZ/su 50-59 YOA Group and Placebo/Historical Control 50-59 YOA Group.||100.00|77.79|
72353511|NCT02723773|144227117|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|74.75|||||TWO_SIDED|95.0|-155.17|99.49|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su 60-69 YOA Group over Placebo/Historical Control 60-69 YOA Group. The VE of HZ/su vaccine against PHN in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of PHN between HZ/su 60-69 YOA Group and Placebo/Historical Control 60-69 YOA Group.||99.49|-155.17|
72353512|NCT02723773|144227117|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|87.24|||||TWO_SIDED|95.0|73.29|94.72|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su \>=60 YOA Group over Placebo/Historical Control \>=60 YOA Group. The VE of HZ/su vaccine against PHN in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of PHN between HZ/su \>=60 YOA Group and Placebo/Historical Control \>=60 YOA Group.||94.72|73.29|
72353513|NCT02723773|144227117|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|88.08|||||TWO_SIDED|95.0|73.87|95.41|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su \>=70 YOA Group over Placebo/Historical Control \>=70 YOA Group. The VE of HZ/su vaccine against PHN in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of PHN between HZ/su \>=70 YOA Group and Placebo/Historical Control \>=70 YOA Group.||95.41|73.87|
72353514|NCT02723773|144227118|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|91.67|||||TWO_SIDED|95.0|43.68|99.81|||Poisson regression method||VE=1-RR. RR=the ratio of the incidence rates of LTFU+Control \>=50 YOA Group over Historical Control \>=50 YOA Group. The VE of HZ/su vaccine against HZ related complications in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ related complications between LTFU+Control \>=50 YOA Group and Historical Control \>=50 YOA Group.||99.81|43.68|
72353515|NCT02723773|144227118|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|100.0|||||TWO_SIDED|95.0|-247.21|100.0|||Poisson regression method||VE=1-RR. RR=the ratio of the incidence rates of LTFU+Control 60-69YOA Group over Historical Control 60-69YOA Group. The VE of HZ/su vaccine against HZ related complications in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ related complications between LTFU+Control 60-69 YOA Group and Historical Control 60-69 YOA Group.||100.00|-247.21|
72353516|NCT02723773|144227118|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|90.91|||||TWO_SIDED|95.0|37.45|99.79|||Poisson regression method||VE=1-RR. RR=the ratio of the incidence rates of LTFU+Control \>=60YOA Group over Historical Control \>=60YOA Group. The VE of HZ/su vaccine against HZ related complications in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy in prevention of HZ related complications between LTFU+Control \>=60 YOA Group and Historical Control \>=60 YOA Group.||99.79|37.45|
72353517|NCT02723773|144227118|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|88.89|||||TWO_SIDED|95.0|19.81|99.75|||Poisson regression method||VE=1-RR. RR=the ratio of the incidence rates of LTFU+Control \>=70YOA Group over Historical Control \>=70YOA Group. The VE of HZ/su vaccine against HZ related complications in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ related complications between LTFU+Control \>=70 YOA Group and Historical Control \>=70 YOA Group.||99.75|19.81|
72353518|NCT02723773|144227119|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|92.83|||||TWO_SIDED|95.0|71.57|99.17|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su \>=50 YOA Group over Placebo/Historical Control \>=50 YOA Group. The VE of HZ/su vaccine against HZ related complications in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ related complications between HZ/su \>=50 YOA Group and Placebo/Historical Control \>=50 YOA Group.||99.17|71.57|
72353519|NCT02723773|144227119|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|100.0|||||TWO_SIDED|95.0|-1830.98|100.0|||Poisson regression method||VE=1-RR. RR=the ratio of the incidence rates of HZ/su 50-59YOA Group over Placebo/Historical Control 50-59YOA Group. The VE of HZ/su vaccine against HZ related complications in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ related complications between HZ/su 50-59 YOA Group and Placebo/Historical Control 50-59 YOA Group.||100.00|-1830.98|
72353520|NCT02723773|144227119|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|100.0|||||TWO_SIDED|95.0|17.55|100.0|||Poisson regression method||VE=1-RR. RR=the ratio of the incidence rates of HZ/su 60-69YOA Group over Placebo/Historical Control 60-69YOA Group. The VE of HZ/su vaccine against HZ related complications in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ related complications between HZ/su 60-69 YOA Group and Placebo/Historical Control 60-69 YOA Group.||100.00|17.55|
72353521|NCT02723773|144227119|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|92.28|||||TWO_SIDED|95.0|69.17|99.11|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su \>=60 YOA Group over Placebo/Historical Control \>=60 YOA Group. The VE of HZ/su vaccine against HZ related complications in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ related complications between HZ/su \>=60 YOA Group and Placebo/Historical Control \>=60 YOA Group.||99.11|69.17|
72353522|NCT02723773|144227119|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|90.45|||||TWO_SIDED|95.0|60.93|98.91|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su \>=70 YOA Group over Placebo/Historical Control \>=70 YOA Group. The VE of HZ/su vaccine against HZ related complications in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ related complications between HZ/su \>=70 YOA Group and Placebo/Historical Control \>=70 YOA Group.||98.91|60.93|
72353523|NCT00387881|144227158|SUPERIORITY_OR_OTHER||Percent difference|18.0|||<|0.001||95.0|10.0|25.0||Endpoints were co-primary and both needed to have p-value of \<0.05 to be considered indicative of efficacy.|Cochran-Mantel-Haenszel||Analysis for Migraine Pain-Free at 2 hours Post-Dose|Pain-Free (2 hours)||25|10|<0.001
72353524|NCT00387881|144227158|SUPERIORITY_OR_OTHER||Percent difference|15.0|||<|0.001||95.0|8.0|22.0|||Cochran-Mantel-Haenszel||Analysis for Sustained Pain Free from 2-24 hours Post-dose|Sustained Pain-Free (2-24 hours)||22|8|<0.001
72353525|NCT03629886|144227173|OTHER|The IR (n/T) of incident cervical infection with HPV-16 (per 100 Person-years rate) was calculated as the number of subjects reporting at least one event (n), over the sum of follow-up period expressed in years (T), and multiplied by 100 and 95% Confidence Intervals (CI) were used for calculation.|Incidence rate per 100 Person-years|0.15|||||TWO_SIDED|95.0|0.09|0.23||||||Analysis was performed to assess the protective effect of HPV Vaccine in terms of incidence rate of HPV-16 incident cervical infection, in subjects who participated in the HPV-039 study and who received HPV vaccine in that study (N=1963). Those subjects were or were not enrolled in the current study, were HPV DNA negative and seronegative subjects at baseline and had cervical samples collected data.||0.23|0.09|
72353526|NCT03629886|144227173|OTHER|The IR (n/T) of incident cervical infection with HPV-16 (per 100 Person-years rate) was calculated as the number of subjects reporting at least one event (n), over the sum of follow-up period expressed in years (T), and multiplied by 100 and 95% Confidence Intervals (CI) were used for calculation.|Incidence rate per 100-Person years|0.88|||||TWO_SIDED|95.0|0.73|1.05||||||Analysis was performed to assess the protective effect of HPV Vaccine in terms of incidence rate of HPV-16 incident cervical infection, in subjects who participated in the HPV-039 study and who received placebo in that study (N=1917). Those subjects were or were not enrolled in the current study, were HPV DNA negative and seronegative subjects at baseline and had cervical samples collected data.||1.05|0.73|
72353527|NCT03629886|144227173|OTHER|The IR (n/T) of incident cervical infection with HPV-18 (per 100 Person-years rate) was calculated as the number of subjects reporting at least one event (n), over the sum of follow-up period expressed in years (T), and multiplied by 100 and 95% Confidence Intervals (CI) were used for calculation.|Incidence rate per 100-Person years|0.09|||||TWO_SIDED|95.0|0.05|0.15||||||Analysis was performed to assess the protective effect of HPV Vaccine in terms of incidence rate of HPV-18 incident cervical infection, in subjects who participated in the HPV-039 study and who received HPV vaccine in that study (N=2356). Those subjects were or were not enrolled in the current study, were HPV DNA negative and seronegative subjects at baseline and had cervical samples collected data.||0.15|0.05|
72353528|NCT03629886|144227173|OTHER|The IR (n/T) of incident cervical infection with HPV-18 (per 100 Person-years rate) was calculated as the number of subjects reporting at least one event (n), over the sum of follow-up period expressed in years (T), and multiplied by 100 and 95% Confidence Intervals (CI) were used for calculation.|Incidence rate per 100-Person years|0.44|||||TWO_SIDED|95.0|0.35|0.56||||||Analysis was performed to assess the protective effect of HPV Vaccine in terms of incidence rate of HPV-18 incident cervical infection, in subjects who participated in the HPV-039 study and who received placebo in that study (N= 2357). Those subjects were or were not enrolled in the current study, were HPV DNA negative and seronegative subjects at baseline and had cervical samples collected data.||0.56|0.35|
72353529|NCT03629886|144227173|OTHER|The IR (n/T) of incident cervical infection with HPV-16 and/or HPV-18 (per 100 Person-years rate) was calculated as the number of subjects reporting at least one event (n), over the sum of follow-up period expressed in years (T), and multiplied by 100 and 95% Confidence Intervals (CI) were used for calculation.|Incidence rate per 100 Person-years|0.2|||||TWO_SIDED|95.0|0.14|0.27||||||Analysis was performed to assess the protective effect of HPV Vaccine in terms of incidence rate of HPV-16/18 incident cervical infection, in subjects who participated in the HPV-039 study and who received HPV vaccine in that study (N=2534). Those subjects were or were not enrolled in the current study, were HPV DNA negative and seronegative subjects at baseline and had cervical samples collected data.||0.27|0.14|
72353530|NCT03629886|144227173|OTHER|The IR (n/T) of incident cervical infection with HPV-16 and/or HPV-18 (per 100 Person-years rate) was calculated as the number of subjects reporting at least one event (n), over the sum of follow-up period expressed in years (T), and multiplied by 100 and 95% Confidence Intervals (CI) were used for calculation.|Incidence rate per 100 Person-years|1.02|||||TWO_SIDED|95.0|0.88|1.18||||||Analysis was performed to assess the protective effect of HPV Vaccine in terms of incidence rate of HPV-16/18 incident cervical infection, in subjects who participated in the HPV-039 study and who received placebo in that study (N= 2547). Those subjects were or were not enrolled in the current study, were HPV DNA negative and seronegative subjects at baseline and had cervical samples collected data.||1.18|0.88|
72353531|NCT03629886|144227174|OTHER|The IR (n/T) of incident cervical infection with HPV-16 and/or HPV-18 (per 100 Person-years rate) was calculated as the number of subjects reporting at least one event (n), over the sum of follow-up period expressed in years (T), and multiplied by 100 and 95% Confidence Intervals (CI) were used for calculation.|Incidence rate per 100-Person years|0.25|||||TWO_SIDED|95.0|0.19|0.33||||||Analysis was performed to assess the protective effect of HPV Vaccine in terms of incidence rate of HPV-16/18 incident cervical infection, in subjects who participated in the HPV-039 study and who received HPV vaccine in that study (N=2818). Those subjects were or were not enrolled in the current study, were HPV DNA negative subjects at baseline and had cervical samples collected data.||0.33|0.19|
72353532|NCT03629886|144227174|OTHER|The IR (n/T) of incident cervical infection with HPV-16 and/or HPV-18 (per 100 Person-years rate) was calculated as the number of subjects reporting at least one event (n), over the sum of follow-up period expressed in years (T), and multiplied by 100 and 95% Confidence Intervals (CI) were used for calculation.|Incidence rate per 100-Person years|1.21|||||TWO_SIDED|95.0|1.06|1.37||||||Analysis was performed to assess the protective effect of HPV Vaccine in terms of incidence rate of HPV-16/18 incident cervical infection, in subjects who participated in the HPV-039 study and who received placebo in that study (N= 2815). Those subjects were or were not enrolled in the current study, were HPV DNA negative subjects at baseline and had cervical samples collected data.||1.37|1.06|
72353533|NCT03629886|144227175|OTHER|The IR (n/T) of incident cervical infection with any oncogenic HPV type or combination of oncogenic HPV types (per 100 Person-years rate) was calculated as the number of subjects reporting at least one event (n) in a group (assessed by detecting HPV DNA using PCR), over the sum of follow-up period expressed in years (T) in the same group, and multiplied by 100 and 95% Confidence Intervals (CI) were used for calculation.|Incidence rate per 100-Person years|0.17|||||TWO_SIDED|95.0|0.11|0.24||||||Analysis was performed to assess the protective effect of HPV Vaccine in terms of incidence rate of oncogenic HPV-16 incident cervical infection, in subjects who participated in the HPV-039 study and who received HPV vaccine in that study (N=2718). Those subjects were or were not enrolled in the current study, were HPV DNA negative subjects at baseline and had cervical samples collected data.||0.24|0.11|
72369528|NCT00943072|144249340|SUPERIORITY_OR_OTHER||Risk Difference (RD)|44.8|||<|0.0001|TWO_SIDED|95.0|33.0|56.6||P-value for the primary endpoint was calculated using 2-sided Cochran-Mantel-Haenszel test adjusted by regions (North America vs. Rest of World) and baseline BCVA (BCVA \> 20/200 and BCVA ≤ 20/200)|Cochran-Mantel-Haenszel|CMH adjusted difference|The Risk Difference (RD) indicates the difference between the IAI (EYLEA, VEGF Trap-Eye) Treatment group minus the Sham Treatment group.|||56.6|33.0|< 0.0001
72369529|NCT00943072|144249341|SUPERIORITY_OR_OTHER||Risk Difference (RD)|21.7|||<|0.0001|TWO_SIDED|95.0|17.36|26.04|||ANCOVA||RD is the IAI group minus sham group. 95% confidence interval is for the RD.|||26.04|17.36|< 0.0001
72369530|NCT00943072|144249341|SUPERIORITY_OR_OTHER||Least Square Mean|16.36|||||||||||ANCOVA||LS Mean indicates is the IAI (EYLEA, VEGF Trap-Eye) Treatment group minus the Sham Treatment group.|||||
72353534|NCT03629886|144227175|OTHER|The IR (n/T) of incident cervical infection with any oncogenic HPV type or combination of oncogenic HPV types (per 100 Person-years rate) was calculated as the number of subjects reporting at least one event (n) in a group (assessed by detecting HPV DNA using PCR), over the sum of follow-up period expressed in years (T) in the same group, and multiplied by 100 and 95% Confidence Intervals (CI) were used for calculation.|Incidence rate per 100-Person years|0.85|||||TWO_SIDED|95.0|0.72|0.99||||||Analysis was performed to assess the protective effect of HPV Vaccine in terms of incidence rate of oncogenic HPV-16 incident cervical infection, in subjects who participated in the HPV-039 study and who received placebo in that study (N= 2722). Those subjects were or were not enrolled in the current study, were HPV DNA negative subjects at baseline and had cervical samples collected data.||0.99|0.72|
72353535|NCT03629886|144227175|OTHER|The IR (n/T) of incident cervical infection with any oncogenic HPV type or combination of oncogenic HPV types (per 100 Person-years rate) was calculated as the number of subjects reporting at least one event (n) in a group (assessed by detecting HPV DNA using PCR), over the sum of follow-up period expressed in years (T) in the same group, and multiplied by 100 and 95% Confidence Intervals (CI) were used for calculation.|Incidence rate per 100-Person years|0.1|||||TWO_SIDED|95.0|0.06|0.15||||||Analysis was performed to assess the protective effect of HPV Vaccine in terms of incidence rate of oncogenic HPV-18 incident cervical infection, in subjects who participated in the HPV-039 study and who received HPV vaccine in that study (N=2781). Those subjects were or were not enrolled in the current study, were HPV DNA negative subjects at baseline and had cervical samples collected data.||0.15|0.06|
72353536|NCT03629886|144227175|OTHER|The IR (n/T) of incident cervical infection with any oncogenic HPV type or combination of oncogenic HPV types (per 100 Person-years rate) was calculated as the number of subjects reporting at least one event (n) in a group (assessed by detecting HPV DNA using PCR), over the sum of follow-up period expressed in years (T) in the same group, and multiplied by 100 and 95% Confidence Intervals (CI) were used for calculation.|Incidence rate per 100-Person years|0.47||||||95.0|0.38|0.58||||||Analysis was performed to assess the protective effect of HPV Vaccine in terms of incidence rate of oncogenic HPV-18 incident cervical infection, in subjects who participated in the HPV-039 study and who received placebo in that study (N= 2781). Those subjects were or were not enrolled in the current study, were HPV DNA negative subjects at baseline and had cervical samples collected data.||0.58|0.38|
72353537|NCT03629886|144227175|OTHER|The IR (n/T) of incident cervical infection with any oncogenic HPV type or combination of oncogenic HPV types (per 100 Person-years rate) was calculated as the number of subjects reporting at least one event (n) in a group (assessed by detecting HPV DNA using PCR), over the sum of follow-up period expressed in years (T) in the same group, and multiplied by 100 and 95% Confidence Intervals (CI) were used for calculation.|Incidence rate per 100-Person years|0.21|||||TWO_SIDED|95.0|0.15|0.28||||||Analysis was performed to assess the protective effect of HPV Vaccine in terms of incidence rate of oncogenic HPV-31 incident cervical infection, in subjects who participated in the HPV-039 study and who received HPV vaccine in that study (N=2786). Those subjects were or were not enrolled in the current study, were HPV DNA negative subjects at baseline and had cervical samples collected data.||0.28|0.15|
72353538|NCT03629886|144227175|OTHER|The IR (n/T) of incident cervical infection with any oncogenic HPV type or combination of oncogenic HPV types (per 100 Person-years rate) was calculated as the number of subjects reporting at least one event (n) in a group (assessed by detecting HPV DNA using PCR), over the sum of follow-up period expressed in years (T) in the same group, and multiplied by 100 and 95% Confidence Intervals (CI) were used for calculation.|Incidence rate per 100-Person years|0.48|||||TWO_SIDED|95.0|0.39|0.59||||||Analysis was performed to assess the protective effect of HPV Vaccine in terms of incidence rate of oncogenic HPV-31 incident cervical infection, in subjects who participated in the HPV-039 study and who received placebo in that study (N= 2782). Those subjects were or were not enrolled in the current study, were HPV DNA negative subjects at baseline and had cervical samples collected data.||0.59|0.39|
72353539|NCT03629886|144227175|OTHER|The IR (n/T) of incident cervical infection with any oncogenic HPV type or combination of oncogenic HPV types (per 100 Person-years rate) was calculated as the number of subjects reporting at least one event (n) in a group (assessed by detecting HPV DNA using PCR), over the sum of follow-up period expressed in years (T) in the same group, and multiplied by 100 and 95% Confidence Intervals (CI) were used for calculation.|Incidence rate per 100-Person years|0.25|||||TWO_SIDED|95.0|0.18|0.33||||||Analysis was performed to assess the protective effect of HPV Vaccine in terms of incidence rate of oncogenic HPV-33 incident cervical infection, in subjects who participated in the HPV-039 study and who received HPV vaccine in that study (N=2779). Those subjects were or were not enrolled in the current study, were HPV DNA negative subjects at baseline and had cervical samples collected data.||0.33|0.18|
72353540|NCT03629886|144227175|OTHER|The IR (n/T) of incident cervical infection with any oncogenic HPV type or combination of oncogenic HPV types (per 100 Person-years rate) was calculated as the number of subjects reporting at least one event (n) in a group (assessed by detecting HPV DNA using PCR), over the sum of follow-up period expressed in years (T) in the same group, and multiplied by 100 and 95% Confidence Intervals (CI) were used for calculation.|Incidence rate per 100-Person years|0.41|||||TWO_SIDED|95.0|0.33|0.51||||||Analysis was performed to assess the protective effect of HPV Vaccine in terms of incidence rate of oncogenic HPV-33 incident cervical infection, in subjects who participated in the HPV-039 study and who received placebo in that study (N= 2784). Those subjects were or were not enrolled in the current study, were HPV DNA negative subjects at baseline and had cervical samples collected data.||0.51|0.33|
72353541|NCT03629886|144227175|OTHER|The IR (n/T) of incident cervical infection with any oncogenic HPV type or combination of oncogenic HPV types (per 100 Person-years rate) was calculated as the number of subjects reporting at least one event (n) in a group (assessed by detecting HPV DNA using PCR), over the sum of follow-up period expressed in years (T) in the same group, and multiplied by 100 and 95% Confidence Intervals (CI) were used for calculation.|Incidence rate per 100-Person years|0.3|||||TWO_SIDED|95.0|0.23|0.39||||||Analysis was performed to assess the protective effect of HPV Vaccine in terms of incidence rate of oncogenic HPV-35 incident cervical infection, in subjects who participated in the HPV-039 study and who received HPV vaccine in that study (N=2806). Those subjects were or were not enrolled in the current study, were HPV DNA negative subjects at baseline and had cervical samples collected data.||0.39|0.23|
72369531|NCT00943072|144249342|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-311.9|||<|0.0001|TWO_SIDED|95.0|-389.4|-234.4|||ANCOVA||The Risk Difference (RD) indicates the difference between the IAI (EYLEA, VEGF Trap-Eye) Treatment group minus the Sham Treatment group. 95% confidence interval is for the RD.|||-234.4|-389.4|< 0.0001
72353542|NCT03629886|144227175|OTHER|The IR (n/T) of incident cervical infection with any oncogenic HPV type or combination of oncogenic HPV types (per 100 Person-years rate) was calculated as the number of subjects reporting at least one event (n) in a group (assessed by detecting HPV DNA using PCR), over the sum of follow-up period expressed in years (T) in the same group, and multiplied by 100 and 95% Confidence Intervals (CI) were used for calculation.|Incidence rate per 100-Person years|0.36|||||TWO_SIDED|95.0|0.28|0.46||||||Analysis was performed to assess the protective effect of HPV Vaccine in terms of incidence rate of oncogenic HPV-35 incident cervical infection, in subjects who participated in the HPV-039 study and who received placebo in that study (N= 2803). Those subjects were or were not enrolled in the current study, were HPV DNA negative subjects at baseline and had cervical samples collected data.||0.46|0.28|
72353543|NCT03629886|144227175|OTHER|The IR (n/T) of incident cervical infection with any oncogenic HPV type or combination of oncogenic HPV types (per 100 Person-years rate) was calculated as the number of subjects reporting at least one event (n) in a group (assessed by detecting HPV DNA using PCR), over the sum of follow-up period expressed in years (T) in the same group, and multiplied by 100 and 95% Confidence Intervals (CI) were used for calculation.|Incidence rate per 100-Person years|0.88||||||95.0|0.75|1.02||||||Analysis was performed to assess the protective effect of HPV Vaccine in terms of incidence rate of oncogenic HPV-39 incident cervical infection, in subjects who participated in the HPV-039 study and who received HPV vaccine in that study (N=2759). Those subjects were or were not enrolled in the current study, were HPV DNA negative subjects at baseline and had cervical samples collected data.||1.02|0.75|
72353544|NCT03629886|144227175|OTHER|The IR (n/T) of incident cervical infection with any oncogenic HPV type or combination of oncogenic HPV types (per 100 Person-years rate) was calculated as the number of subjects reporting at least one event (n) in a group (assessed by detecting HPV DNA using PCR), over the sum of follow-up period expressed in years (T) in the same group, and multiplied by 100 and 95% Confidence Intervals (CI) were used for calculation.|Incidence rate per 100-Person years|0.79|||||TWO_SIDED|95.0|0.67|0.93||||||Analysis was performed to assess the protective effect of HPV Vaccine in terms of incidence rate of oncogenic HPV-39 incident cervical infection, in subjects who participated in the HPV-039 study and who received placebo in that study (N= 2773). Those subjects were or were not enrolled in the current study, were HPV DNA negative subjects at baseline and had cervical samples collected data.||0.93|0.67|
72353545|NCT03629886|144227175|OTHER|The IR (n/T) of incident cervical infection with any oncogenic HPV type or combination of oncogenic HPV types (per 100 Person-years rate) was calculated as the number of subjects reporting at least one event (n) in a group (assessed by detecting HPV DNA using PCR), over the sum of follow-up period expressed in years (T) in the same group, and multiplied by 100 and 95% Confidence Intervals (CI) were used for calculation.|Incidence rate per 100-Person years|0.11|||||TWO_SIDED|95.0|0.07|0.16||||||Analysis was performed to assess the protective effect of HPV Vaccine in terms of incidence rate of oncogenic HPV-45 incident cervical infection, in subjects who participated in the HPV-039 study and who received HPV vaccine in that study (N=2794). Those subjects were or were not enrolled in the current study, were HPV DNA negative subjects at baseline and had cervical samples collected data.||0.16|0.07|
72353546|NCT03629886|144227175|OTHER|The IR (n/T) of incident cervical infection with any oncogenic HPV type or combination of oncogenic HPV types (per 100 Person-years rate) was calculated as the number of subjects reporting at least one event (n) in a group (assessed by detecting HPV DNA using PCR), over the sum of follow-up period expressed in years (T) in the same group, and multiplied by 100 and 95% Confidence Intervals (CI) were used for calculation.|Incidence rate per 100-Person years|0.21|||||TWO_SIDED|95.0|0.15|0.28||||||Analysis was performed to assess the protective effect of HPV Vaccine in terms of incidence rate of oncogenic HPV-45 incident cervical infection, in subjects who participated in the HPV-039 study and who received placebo in that study (N= 2802). Those subjects were or were not enrolled in the current study, were HPV DNA negative subjects at baseline and had cervical samples collected data.||0.28|0.15|
72353547|NCT03629886|144227175|OTHER|The IR (n/T) of incident cervical infection with any oncogenic HPV type or combination of oncogenic HPV types (per 100 Person-years rate) was calculated as the number of subjects reporting at least one event (n) in a group (assessed by detecting HPV DNA using PCR), over the sum of follow-up period expressed in years (T) in the same group, and multiplied by 100 and 95% Confidence Intervals (CI) were used for calculation.|Incidence rate per 100-Person years|1.02|||||TWO_SIDED|95.0|0.88|1.18||||||Analysis was performed to assess the protective effect of HPV Vaccine in terms of incidence rate of oncogenic HPV-51 incident cervical infection, in subjects who participated in the HPV-039 study and who received HPV vaccine in that study (N=2753). Those subjects were or were not enrolled in the current study, were HPV DNA negative subjects at baseline and had cervical samples collected data.||1.18|0.88|
72353548|NCT03629886|144227175|OTHER|The IR (n/T) of incident cervical infection with any oncogenic HPV type or combination of oncogenic HPV types (per 100 Person-years rate) was calculated as the number of subjects reporting at least one event (n) in a group (assessed by detecting HPV DNA using PCR), over the sum of follow-up period expressed in years (T) in the same group, and multiplied by 100 and 95% Confidence Intervals (CI) were used for calculation.|Incidence rate per 100-Person years|1.18|||||TWO_SIDED|95.0|1.03|1.34||||||Analysis was performed to assess the protective effect of HPV Vaccine in terms of incidence rate of oncogenic HPV-51 incident cervical infection, in subjects who participated in the HPV-039 study and who received placebo in that study (N=2756). Those subjects were or were not enrolled in the current study, were HPV DNA negative subjects at baseline and had cervical samples collected data.||1.34|1.03|
72353549|NCT03629886|144227175|OTHER|The IR (n/T) of incident cervical infection with any oncogenic HPV type or combination of oncogenic HPV types (per 100 Person-years rate) was calculated as the number of subjects reporting at least one event (n) in a group (assessed by detecting HPV DNA using PCR), over the sum of follow-up period expressed in years (T) in the same group, and multiplied by 100 and 95% Confidence Intervals (CI) were used for calculation.|Incidence rate per 100-Person years|1.67|||||TWO_SIDED|95.0|1.48|1.87||||||Analysis was performed to assess the protective effect of HPV Vaccine in terms of incidence rate of oncogenic HPV-52 incident cervical infection, in subjects who participated in the HPV-039 study and who received HPV vaccine in that study (N=2666). Those subjects were or were not enrolled in the current study, were HPV DNA negative subjects at baseline and had cervical samples collected data.||1.87|1.48|
72369532|NCT00943072|144249342|SUPERIORITY_OR_OTHER||Least Square Mean|-487.1|||||||||||ANCOVA||The Least Square Mean indicates the difference between the IAI (EYLEA, VEGF Trap-Eye) Treatment group minus the Sham Treatment group.|||||
72353550|NCT03629886|144227175|OTHER|The IR (n/T) of incident cervical infection with any oncogenic HPV type or combination of oncogenic HPV types (per 100 Person-years rate) was calculated as the number of subjects reporting at least one event (n) in a group (assessed by detecting HPV DNA using PCR), over the sum of follow-up period expressed in years (T) in the same group, and multiplied by 100 and 95% Confidence Intervals (CI) were used for calculation.|Incidence rate per 100-Person years|1.8|||||TWO_SIDED|95.0|1.61|2.0||||||Analysis was performed to assess the protective effect of HPV Vaccine in terms of incidence rate of oncogenic HPV-52 incident cervical infection, in subjects who participated in the HPV-039 study and who received placebo in that study (N=2663). Those subjects were or were not enrolled in the current study, were HPV DNA negative subjects at baseline and had cervical samples collected data.||2.00|1.61|
72353551|NCT03629886|144227175|OTHER|The IR (n/T) of incident cervical infection with any oncogenic HPV type or combination of oncogenic HPV types (per 100 Person-years rate) was calculated as the number of subjects reporting at least one event (n) in a group (assessed by detecting HPV DNA using PCR), over the sum of follow-up period expressed in years (T) in the same group, and multiplied by 100 and 95% Confidence Intervals (CI) were used for calculation.|Incidence rate per 100-Person years|0.61|||||TWO_SIDED|95.0|0.5|0.73||||||Analysis was performed to assess the protective effect of HPV Vaccine in terms of incidence rate of oncogenic HPV-56 incident cervical infection, in subjects who participated in the HPV-039 study and who received HPV vaccine in that study (N=2783). Those subjects were or were not enrolled in the current study, were HPV DNA negative subjects at baseline and had cervical samples collected data.||0.73|0.50|
72353552|NCT03629886|144227175|OTHER|The IR (n/T) of incident cervical infection with any oncogenic HPV type or combination of oncogenic HPV types (per 100 Person-years rate) was calculated as the number of subjects reporting at least one event (n) in a group (assessed by detecting HPV DNA using PCR), over the sum of follow-up period expressed in years (T) in the same group, and multiplied by 100 and 95% Confidence Intervals (CI) were used for calculation.|Incidence rate per 100-Person years|0.64|||||TWO_SIDED|95.0|0.53|0.76||||||Analysis was performed to assess the protective effect of HPV Vaccine in terms of incidence rate of oncogenic HPV-56 incident cervical infection, in subjects who participated in the HPV-039 study and who received placebo in that study (N=2779). Those subjects were or were not enrolled in the current study, were HPV DNA negative subjects at baseline and had cervical samples collected data.||0.76|0.53|
72353553|NCT03629886|144227175|OTHER|The IR (n/T) of incident cervical infection with any oncogenic HPV type or combination of oncogenic HPV types (per 100 Person-years rate) was calculated as the number of subjects reporting at least one event (n) in a group (assessed by detecting HPV DNA using PCR), over the sum of follow-up period expressed in years (T) in the same group, and multiplied by 100 and 95% Confidence Intervals (CI) were used for calculation.|Incidence rate per 100-Person years|0.51|||||TWO_SIDED|95.0|0.42|0.62||||||Analysis was performed to assess the protective effect of HPV Vaccine in terms of incidence rate of oncogenic HPV-58 incident cervical infection, in subjects who participated in the HPV-039 study and who received HPV vaccine in that study (N=2772). Those subjects were or were not enrolled in the current study, were HPV DNA negative subjects at baseline and had cervical samples collected data.||0.62|0.42|
72353554|NCT03629886|144227175|OTHER|The IR (n/T) of incident cervical infection with any oncogenic HPV type or combination of oncogenic HPV types (per 100 Person-years rate) was calculated as the number of subjects reporting at least one event (n) in a group (assessed by detecting HPV DNA using PCR), over the sum of follow-up period expressed in years (T) in the same group, and multiplied by 100 and 95% Confidence Intervals (CI) were used for calculation.|Incidence rate per 100-Person years|0.65||||||95.0|0.55|0.77||||||Analysis was performed to assess the protective effect of HPV Vaccine in terms of incidence rate of oncogenic HPV-58 incident cervical infection, in subjects who participated in the HPV-039 study and who received placebo in that study (N=2768). Those subjects were or were not enrolled in the current study, were HPV DNA negative subjects at baseline and had cervical samples collected data.||0.77|0.55|
72353555|NCT03629886|144227175|OTHER|The IR (n/T) of incident cervical infection with any oncogenic HPV type or combination of oncogenic HPV types (per 100 Person-years rate) was calculated as the number of subjects reporting at least one event (n) in a group (assessed by detecting HPV DNA using PCR), over the sum of follow-up period expressed in years (T) in the same group, and multiplied by 100 and 95% Confidence Intervals (CI) were used for calculation.|Incidence rate per 100-Person years|0.31|||||TWO_SIDED|95.0|0.24|0.4||||||Analysis was performed to assess the protective effect of HPV Vaccine in terms of incidence rate of oncogenic HPV-59 incident cervical infection, in subjects who participated in the HPV-039 study and who received HPV vaccine in that study (N=2814). Those subjects were or were not enrolled in the current study, were HPV DNA negative subjects at baseline and had cervical samples collected data.||0.40|0.24|
72353556|NCT03629886|144227175|OTHER|The IR (n/T) of incident cervical infection with any oncogenic HPV type or combination of oncogenic HPV types (per 100 Person-years rate) was calculated as the number of subjects reporting at least one event (n) in a group (assessed by detecting HPV DNA using PCR), over the sum of follow-up period expressed in years (T) in the same group, and multiplied by 100 and 95% Confidence Intervals (CI) were used for calculation.|Incidence rate per 100-Person years|0.36|||||TWO_SIDED|95.0|0.28|0.45||||||Analysis was performed to assess the protective effect of HPV Vaccine in terms of incidence rate of oncogenic HPV-59 incident cervical infection, in subjects who participated in the HPV-039 study and who received placebo in that study (N=2797). Those subjects were or were not enrolled in the current study, were HPV DNA negative subjects at baseline and had cervical samples collected data.||0.45|0.28|
72369533|NCT00943072|144249343|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-6.6||||0.0059|TWO_SIDED|95.0|-12.2|-1.1|||Cochran-Mantel-Haenszel|CMH adjusted difference|The Risk Difference (RD) indicates the difference between the IAI (EYLEA, VEGF Trap-Eye) Treatment group minus the Sham Treatment group. 95% confidence interval is for the RD.|||-1.1|-12.2|0.0059
72369534|NCT00943072|144249344|SUPERIORITY_OR_OTHER||Risk Difference (RD)|6.26||||0.0009|TWO_SIDED|95.0|2.61|9.91|||ANCOVA||The Risk Difference (RD) indicates the difference between the IAI (EYLEA, VEGF Trap-Eye) Treatment group minus the Sham Treatment group. 95% confidence interval is for the RD.|||9.91|2.61|0.0009
72369535|NCT00943072|144249344|SUPERIORITY_OR_OTHER||Least Square Mean|8.8|||||||||||ANCOVA||Least Square Mean indicates the difference between the IAI (EYLEA, VEGF Trap-Eye) Treatment group minus the Sham Treatment group.|||||
72369536|NCT00552188|144249345|SUPERIORITY_OR_OTHER|||||||0.34|TWO_SIDED|95.0|||||ANCOVA|||ANCOVA model adjusted for baseline value||||0.34
72369537|NCT00552188|144249346|SUPERIORITY_OR_OTHER|||||||0.15|TWO_SIDED|95.0|||||ANCOVA|||ANCOVA model adjusted for baseline||||0.15
72353557|NCT03629886|144227175|OTHER|The IR (n/T) of incident cervical infection with any oncogenic HPV type or combination of oncogenic HPV types (per 100 Person-years rate) was calculated as the number of subjects reporting at least one event (n) in a group (assessed by detecting HPV DNA using PCR), over the sum of follow-up period expressed in years (T) in the same group, and multiplied by 100 and 95% Confidence Intervals (CI) were used for calculation.|Incidence rate per 100-Person years|0.62|||||TWO_SIDED|95.0|0.51|0.74||||||Analysis was performed to assess the protective effect of HPV Vaccine in terms of incidence rate of oncogenic HPV-66 incident cervical infection, in subjects who participated in the HPV-039 study and who received HPV vaccine in that study (N=2779). Those subjects were or were not enrolled in the current study, were HPV DNA negative subjects at baseline and had cervical samples collected data.||0.74|0.51|
72353558|NCT03629886|144227175|OTHER|The IR (n/T) of incident cervical infection with any oncogenic HPV type or combination of oncogenic HPV types (per 100 Person-years rate) was calculated as the number of subjects reporting at least one event (n) in a group (assessed by detecting HPV DNA using PCR), over the sum of follow-up period expressed in years (T) in the same group, and multiplied by 100 and 95% Confidence Intervals (CI) were used for calculation.|Incidence rate per 100-Person years|0.64|||||TWO_SIDED|95.0|0.54|0.77||||||Analysis was performed to assess the protective effect of HPV Vaccine in terms of incidence rate of oncogenic HPV-66 incident cervical infection, in subjects who participated in the HPV-039 study and who received placebo in that study (N=2763). Those subjects were or were not enrolled in the current study, were HPV DNA negative subjects at baseline and had cervical samples collected data.||0.77|0.54|
72353559|NCT03629886|144227175|OTHER|The IR (n/T) of incident cervical infection with any oncogenic HPV type or combination of oncogenic HPV types (per 100 Person-years rate) was calculated as the number of subjects reporting at least one event (n) in a group (assessed by detecting HPV DNA using PCR), over the sum of follow-up period expressed in years (T) in the same group, and multiplied by 100 and 95% Confidence Intervals (CI) were used for calculation.|Incidence rate per 100-Person years|0.56||||||95.0|0.46|0.68||||||Analysis was performed to assess the protective effect of HPV Vaccine in terms of incidence rate of oncogenic HPV-68 incident cervical infection, in subjects who participated in the HPV-039 study and who received HPV vaccine in that study (N=2775). Those subjects were or were not enrolled in the current study, were HPV DNA negative subjects at baseline and had cervical samples collected data.||0.68|0.46|
72353560|NCT03629886|144227175|OTHER|The IR (n/T) of incident cervical infection with any oncogenic HPV type or combination of oncogenic HPV types (per 100 Person-years rate) was calculated as the number of subjects reporting at least one event (n) in a group (assessed by detecting HPV DNA using PCR), over the sum of follow-up period expressed in years (T) in the same group, and multiplied by 100 and 95% Confidence Intervals (CI) were used for calculation.|Incidence rate per 100-Person years|0.59|||||TWO_SIDED|95.0|0.49|0.71||||||Analysis was performed to assess the protective effect of HPV Vaccine in terms of incidence rate of oncogenic HPV-68 incident cervical infection, in subjects who participated in the HPV-039 study and who received placebo in that study (N=2785). Those subjects were or were not enrolled in the current study, were HPV DNA negative subjects at baseline and had cervical samples collected data.||0.71|0.49|
72353561|NCT03629886|144227175|OTHER|The IR (n/T) of incident cervical infection with any oncogenic HPV type or combination of oncogenic HPV types (per 100 Person-years rate) was calculated as the number of subjects reporting at least one event (n) in a group (assessed by detecting HPV DNA using PCR), over the sum of follow-up period expressed in years (T) in the same group, and multiplied by 100 and 95% Confidence Intervals (CI) were used for calculation.|Incidence rate per 100-Person years|0.5|||||TWO_SIDED|95.0|0.41|0.61||||||Analysis was performed to assess the protective effect of HPV Vaccine in terms of incidence rate of oncogenic HPV-31/33/45 incident cervical infection, in subjects who participated in the HPV-039 study and who received HPV vaccine in that study (N=2823). Those subjects were or were not enrolled in the current study, were HPV DNA negative subjects at baseline and had cervical samples collected data.||0.61|0.41|
72353562|NCT03629886|144227175|OTHER|The IR (n/T) of incident cervical infection with any oncogenic HPV type or combination of oncogenic HPV types (per 100 Person-years rate) was calculated as the number of subjects reporting at least one event (n) in a group (assessed by detecting HPV DNA using PCR), over the sum of follow-up period expressed in years (T) in the same group, and multiplied by 100 and 95% Confidence Intervals (CI) were used for calculation.|Incidence rate per 100-Person years|0.97|||||TWO_SIDED|95.0|0.84|1.12||||||Analysis was performed to assess the protective effect of HPV Vaccine in terms of incidence rate of oncogenic HPV-31/33/45 incident cervical infection, in subjects who participated in the HPV-039 study and who received placebo in that study (N=2824). Those subjects were or were not enrolled in the current study, were HPV DNA negative subjects at baseline and had cervical samples collected data.||1.12|0.84|
72353563|NCT03629886|144227175|OTHER|The IR (n/T) of incident cervical infection with any oncogenic HPV type or combination of oncogenic HPV types (per 100 Person-years rate) was calculated as the number of subjects reporting at least one event (n) in a group (assessed by detecting HPV DNA using PCR), over the sum of follow-up period expressed in years (T) in the same group, and multiplied by 100 and 95% Confidence Intervals (CI) were used for calculation.|Incidence rate per 100-Person years|0.75|||||TWO_SIDED|95.0|0.63|0.88||||||Analysis was performed to assess the protective effect of HPV Vaccine in terms of incidence rate of oncogenic HPV-16/18/33/31/45 incident cervical infection, in subjects who participated in the HPV-039 study and who received HPV vaccine in that study (N=2823). Those subjects were or were not enrolled in the current study, were HPV DNA negative subjects at baseline and had cervical samples collected data.||0.88|0.63|
72353564|NCT03629886|144227175|OTHER|The IR (n/T) of incident cervical infection with any oncogenic HPV type or combination of oncogenic HPV types (per 100 Person-years rate) was calculated as the number of subjects reporting at least one event (n) in a group (assessed by detecting HPV DNA using PCR), over the sum of follow-up period expressed in years (T) in the same group, and multiplied by 100 and 95% Confidence Intervals (CI) were used for calculation.|Incidence rate per 100-Person years|2.11|||||TWO_SIDED|95.0|1.91|2.33||||||Analysis was performed to assess the protective effect of HPV Vaccine in terms of incidence rate of oncogenic HPV-16/18/33/31/45 incident cervical infection, in subjects who participated in the HPV-039 study and who received placebo in that study (N=2825). Those subjects were or were not enrolled in the current study, were HPV DNA negative subjects at baseline and had cervical samples collected data.||2.33|1.91|
72353565|NCT03629886|144227175|OTHER|The IR (n/T) of incident cervical infection with any oncogenic HPV type or combination of oncogenic HPV types (per 100 Person-years rate) was calculated as the number of subjects reporting at least one event (n) in a group (assessed by detecting HPV DNA using PCR), over the sum of follow-up period expressed in years (T) in the same group, and multiplied by 100 and 95% Confidence Intervals (CI) were used for calculation.|Incidence rate per 100-Person years|5.13|||||TWO_SIDED|95.0|4.79|5.49||||||Analysis was performed to assess the protective effect of HPV Vaccine in terms of incidence rate of oncogenic HRW-HPV incident cervical infection, in subjects who participated in the HPV-039 study and who received HPV vaccine in that study (N=2823). Those subjects were or were not enrolled in the current study, were HPV DNA negative subjects at baseline and had cervical samples collected data.||5.49|4.79|
72353566|NCT03629886|144227175|OTHER|The IR (n/T) of incident cervical infection with any oncogenic HPV type or combination of oncogenic HPV types (per 100 Person-years rate) was calculated as the number of subjects reporting at least one event (n) in a group (assessed by detecting HPV DNA using PCR), over the sum of follow-up period expressed in years (T) in the same group, and multiplied by 100 and 95% Confidence Intervals (CI) were used for calculation.|Incidence rate per 100-Person years|5.72|||||TWO_SIDED|95.0|5.36|6.1||||||Analysis was performed to assess the protective effect of HPV Vaccine in terms of incidence rate of oncogenic HRW-HPV incident cervical infection, in subjects who participated in the HPV-039 study and who received placebo in that study (N=2825). Those subjects were or were not enrolled in the current study, were HPV DNA negative subjects at baseline and had cervical samples collected data.||6.10|5.36|
72353567|NCT03629886|144227175|OTHER|The IR (n/T) of incident cervical infection with any oncogenic HPV type or combination of oncogenic HPV types (per 100 Person-years rate) was calculated as the number of subjects reporting at least one event (n) in a group (assessed by detecting HPV DNA using PCR), over the sum of follow-up period expressed in years (T) in the same group, and multiplied by 100 and 95% Confidence Intervals (CI) were used for calculation.|Incidence rate per 100-Person years|5.29|||||TWO_SIDED|95.0|4.94|5.65||||||Analysis was performed to assess the protective effect of HPV Vaccine in terms of incidence rate of oncogenic HR-HPV incident cervical infection, in subjects who participated in the HPV-039 study and who received HPV vaccine in that study (N=2823). Those subjects were or were not enrolled in the current study, were HPV DNA negative subjects at baseline and had cervical samples collected data.||5.65|4.94|
72353568|NCT03629886|144227175|OTHER|The IR (n/T) of incident cervical infection with any oncogenic HPV type or combination of oncogenic HPV types (per 100 Person-years rate) was calculated as the number of subjects reporting at least one event (n) in a group (assessed by detecting HPV DNA using PCR), over the sum of follow-up period expressed in years (T) in the same group, and multiplied by 100 and 95% Confidence Intervals (CI) were used for calculation.|Incidence rate per 100-Person years|6.29|||||TWO_SIDED|95.0|5.91|6.69||||||Analysis was performed to assess the protective effect of HPV Vaccine in terms of incidence rate of oncogenic HR-HPV incident cervical infection, in subjects who participated in the HPV-039 study and who received placebo in that study (N=2825). Those subjects were or were not enrolled in the current study, were HPV DNA negative subjects at baseline and had cervical samples collected data.||6.69|5.91|
72353569|NCT00496015|144227181|SUPERIORITY|Superiority criteria: The lower limit (LL) of the standardized asymptotic 95% confidence interval (CI) for the difference between groups (Synflorix PRE Group minus Synflorix I Group) was above 0%.|Difference in percentages|22.18|||||TWO_SIDED|95.0|11.78|32.11||||||||32.11|11.78|
72353570|NCT00527735|144227214|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.806||||0.1302|TWO_SIDED|95.0|0.553|1.174|||1-sided log rank|||||1.174|0.553|0.1302
72353571|NCT00527735|144227214|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.724||||0.0473|TWO_SIDED|95.0|0.495|1.059|||1-sided log rank|||||1.059|0.495|0.0473
72353572|NCT00527735|144227215|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.882||||0.2502|TWO_SIDED|95.0|0.612|1.271|||One-sided log rank|||||1.271|0.612|0.2502
72353573|NCT00527735|144227215|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.691||||0.024|TWO_SIDED|95.0|0.478|0.999|||One-sided log rank|||||0.999|0.478|0.0240
72353574|NCT00527735|144227216|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.988||||0.4759|TWO_SIDED|95.0|0.669|1.46|||1-sided log rank|||||1.460|0.669|0.4759
72353575|NCT00527735|144227216|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.866||||0.234|TWO_SIDED|95.0|0.587|1.278|||1-sided log rank|||||1.278|0.587|0.2340
72353576|NCT00527735|144227223|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.751||||0.1098|TWO_SIDED|95.0|0.475|1.188|||1-sided log rank|||||1.188|0.475|0.1098
72353577|NCT00527735|144227223|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.64||||0.0282|TWO_SIDED|95.0|0.403|1.1016|||1-sided log rank|||||1.1016|0.403|0.0282
72353578|NCT00527735|144227232|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.933||||0.3846|TWO_SIDED|95.0|0.588|1.481|||1-sided Log Rank|||||1.481|0.588|0.3846
72353579|NCT00527735|144227232|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.927||||0.37|TWO_SIDED|95.0|0.591|1.453|||1-sided Log Rank|||||1.453|0.591|0.3700
72353580|NCT00527735|144227235|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.947||||0.4132|TWO_SIDED|95.0|0.585|1.536|||1-sided Log Rank|||||1.536|0.585|0.4132
72353581|NCT00527735|144227235|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.753||||0.1287|TWO_SIDED|95.0|0.461|1.232|||1-sided Log Rank|||||1.232|0.461|0.1287
72353582|NCT00346216|144227279|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non inferiority required a hazard ratio of 1.12 or lower, as well as an upper 95% confidence limit of 1.33 or lower in the ITT population and of 1.40 or lower in the MITT population.|Hazard Ratio (HR)|0.93||||0.0002|TWO_SIDED|95.0|0.76|1.13||Non inferiority P value, α=0.025|Regression, Cox|||ITT Population||1.13|0.76|0.0002
72353583|NCT00346216|144227279|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority requires the hazard ratio does not exceed 1.12, and the upper bound of the two-sided 95% CI for the hazard ratio estimate does not exceed 1.40|Hazard Ratio (HR)|0.9||||0.0001|TWO_SIDED|95.0|0.72|1.14||Non inferiority P value, α=0.025|Regression, Cox|||MITT Population||1.14|0.72|0.0001
72353584|NCT00346216|144227279|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority requires the hazard ratio does not exceed 1.12, and the upper bound of the two-sided 95% CI for the hazard ratio estimate does not exceed 1.33|Hazard Ratio (HR)|0.86|||<|0.0001|TWO_SIDED|95.0|0.7|1.04||Non inferiority P value, α=0.025|Regression, Cox|||ITT Population||1.04|0.70|<0.0001
72353585|NCT00346216|144227279|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority requires the hazard ratio does not exceed 1.12, and the upper bound of the two-sided 95% CI for the hazard ratio (HR) estimate does not exceed 1.40|Hazard Ratio (HR)|0.81|||<|0.0001|TWO_SIDED|95.0|0.64|1.02||Non-inferiority P-value, α=0.025|Regression, Cox|||MITT Population||1.02|0.64|<0.0001
72353586|NCT00346216|144227279|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority requires the hazard ratio does not exceed 1.12, and the upper bound of the two-sided 95% CI for the hazard ratio (HR) estimate does not exceed 1.33|Hazard Ratio (HR)|1.08||||0.0182|TWO_SIDED|95.0|0.89|1.31||Non-inferiority P-value, α=0.025|Regression, Cox|||ITT Population||1.31|0.89|0.0182
72353587|NCT00346216|144227279|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority requires the hazard ratio does not exceed 1.12, and the upper bound of the two-sided 95% CI for the hazard ratio (HR) estimate does not exceed 1.40|Hazard Ratio (HR)|1.12||||0.025|TWO_SIDED|95.0|0.89|1.4||Non-inferiority P-value, α=0.025|Regression, Cox|||MITT Population||1.40|0.89|0.0250
72353588|NCT00346216|144227280|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.97||||0.6427|TWO_SIDED|95.0|0.83|1.12|||Regression, Cox|||ITT Population||1.12|0.83|0.6427
72353589|NCT00346216|144227280|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.87||||0.0597|TWO_SIDED|95.0|0.75|1.01|||Regression, Cox|||ITT Population||1.01|0.75|0.0597
72353590|NCT00346216|144227280|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.11||||0.1481|TWO_SIDED|95.0|0.96|1.29|||Regression, Cox|||ITT Population||1.29|0.96|0.1481
72353591|NCT00346216|144227280|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.95||||0.5758|TWO_SIDED|95.0|0.8|1.13|||Regression, Cox|||MITT Population||1.13|0.80|0.5758
72353592|NCT00346216|144227280|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.82||||0.0204|TWO_SIDED|95.0|0.69|0.97|||Regression, Cox|||MITT Population||0.97|0.69|0.0204
72353593|NCT00346216|144227280|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.17||||0.0751|TWO_SIDED|95.0|0.98|1.38|||Regression, Cox|||MITT Population||1.38|0.98|0.0751
72353594|NCT00346216|144227281|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.97||||0.8576|TWO_SIDED|95.0|0.67|1.4|||Regression, Cox|||ITT Population||1.40|0.67|0.8576
72353595|NCT00346216|144227281|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.76||||0.1202|TWO_SIDED|95.0|0.53|1.08|||Regression, Cox|||ITT Population||1.08|0.53|0.1202
72353596|NCT00346216|144227281|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.27||||0.1734|TWO_SIDED|95.0|0.9|1.81|||Regression, Cox|||ITT Population||1.81|0.90|0.1734
72353597|NCT00346216|144227281|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.51||||0.0041|TWO_SIDED|95.0|0.32|0.81|||Regression, Cox|||MITT Population||0.81|0.32|0.0041
72353598|NCT00346216|144227281|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.43||||0.0003|TWO_SIDED|95.0|0.27|0.68|||Regression, Cox|||MITT Population||0.68|0.27|0.0003
72353599|NCT00346216|144227281|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.16||||0.4243|TWO_SIDED|95.0|0.8|1.69|||Regression, Cox|||MITT Population||1.69|0.80|0.4243
72353600|NCT00346216|144227282|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.77|STANDARD_ERROR_OF_MEAN|0.39|<|0.0001|TWO_SIDED|95.0|1.01|2.53|||Mixed Models Analysis|||Change from baseline to Month 1 (ITT)||2.53|1.01|<0.0001
72353601|NCT00346216|144227282|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.81|STANDARD_ERROR_OF_MEAN|0.39||0.0373|TWO_SIDED|95.0|0.05|1.56|||Mixed Models Analysis|||Change from baseline to Month 1 (ITT)||1.56|0.05|0.0373
72353602|NCT00346216|144227282|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.96|STANDARD_ERROR_OF_MEAN|0.39||0.0129|TWO_SIDED|95.0|0.2|1.72|||Mixed Models Analysis|||Change from baseline to Month 1 (ITT)||1.72|0.20|0.0129
72353603|NCT00346216|144227282|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.52|STANDARD_ERROR_OF_MEAN|0.39||0.183|TWO_SIDED|95.0|-0.25|1.29|||Mixed Models Analysis|||Change from baseline to Month 2 (ITT)||1.29|-0.25|0.1830
72353604|NCT00346216|144227282|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.11|STANDARD_ERROR_OF_MEAN|0.39||0.7777|TWO_SIDED|95.0|-0.88|0.66|||Mixed Models Analysis|||Change from baseline to Month 2 (ITT)||0.66|-0.88|0.7777
72353605|NCT00346216|144227282|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.63|STANDARD_ERROR_OF_MEAN|0.39||0.1072|TWO_SIDED|95.0|-0.14|1.4|||Mixed Models Analysis|||Change from baseline to Month 2 (ITT)||1.40|-0.14|0.1072
72353606|NCT00346216|144227282|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.67|STANDARD_ERROR_OF_MEAN|0.4||0.8237|TWO_SIDED|95.0|-0.12|1.46|||Mixed Models Analysis|||Change from baseline to Month 4 (ITT)||1.46|-0.12|0.8237
72353607|NCT00346216|144227282|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.09|STANDARD_ERROR_OF_MEAN|0.4||0.8237|TWO_SIDED|95.0|-0.88|0.7|||Mixed Models Analysis|||Change from baseline to Month 4 (ITT)||0.70|-0.88|0.8237
72353608|NCT00346216|144227282|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.76|STANDARD_ERROR_OF_MEAN|0.4||0.0587|TWO_SIDED|95.0|-0.03|1.55|||Mixed Models Analysis|||Change from baseline to Month 4 (ITT)||1.55|-0.03|0.0587
72353609|NCT00346216|144227282|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.42|STANDARD_ERROR_OF_MEAN|0.41||0.3129|TWO_SIDED|95.0|-0.39|1.23|||Mixed Models Analysis|||Change from baseline to Month 8 (ITT)||1.23|-0.39|0.3129
72353610|NCT00346216|144227282|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.19|STANDARD_ERROR_OF_MEAN|0.41||0.6526|TWO_SIDED|95.0|-0.63|1.0|||Mixed Models Analysis|||Change from baseline to Month 8 (ITT)||1.00|-0.63|0.6526
72353611|NCT00346216|144227282|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.23|STANDARD_ERROR_OF_MEAN|0.42||0.5774|TWO_SIDED|95.0|-0.58|1.05|||Mixed Models Analysis|||Change from baseline to Month 8 (ITT)||1.05|-0.58|0.5774
72353612|NCT00346216|144227282|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.79|STANDARD_ERROR_OF_MEAN|0.42||0.0632|TWO_SIDED|95.0|-0.04|1.62|||Mixed Models Analysis|||Change from baseline to Month 12 (ITT)||1.62|-0.04|0.0632
72353613|NCT00346216|144227282|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.32|STANDARD_ERROR_OF_MEAN|0.43||0.454|TWO_SIDED|95.0|-0.52|1.15|||Mixed Models Analysis|||Change from baseline to Month 12 (ITT)||1.15|-0.52|0.4540
72353614|NCT00346216|144227282|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.47|STANDARD_ERROR_OF_MEAN|0.43||0.2705|TWO_SIDED|95.0|-0.37|1.3|||Mixed Models Analysis|||Change from baseline to Month 12 (ITT)||1.30|-0.37|0.2705
72353615|NCT00346216|144227282|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.28|STANDARD_ERROR_OF_MEAN|0.44||0.5225|TWO_SIDED|95.0|-0.58|1.14|||Mixed Models Analysis|||Change from baseline to Month 18 (ITT)||1.14|-0.58|0.5225
72353616|NCT00346216|144227282|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.23|STANDARD_ERROR_OF_MEAN|0.44||0.5996|TWO_SIDED|95.0|-1.1|0.63|||Mixed Models Analysis|||Change from baseline to Month 18 (ITT)||0.63|-1.10|0.5996
72353617|NCT00346216|144227282|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.51|STANDARD_ERROR_OF_MEAN|0.44||0.2461|TWO_SIDED|95.0|-0.35|1.38|||Mixed Models Analysis|||Change from baseline to Month 18 (ITT)||1.38|-0.35|0.2461
72353618|NCT00346216|144227282|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.11|STANDARD_ERROR_OF_MEAN|0.46||0.8127|TWO_SIDED|95.0|-0.79|1.0|||Mixed Models Analysis|||Change from baseline to Month 24 (ITT)||1.00|-0.79|0.8127
72353619|NCT00346216|144227282|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.46||0.9641|TWO_SIDED|95.0|-0.92|0.87|||Mixed Models Analysis|||Change from baseline to Month 24 (ITT)||0.87|-0.92|0.9641
72353620|NCT00346216|144227282|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.13|STANDARD_ERROR_OF_MEAN|0.46||0.7784|TWO_SIDED|95.0|-0.77|1.03|||Mixed Models Analysis|||Change from baseline to Month 24 (ITT)||1.03|-0.77|0.7784
72353621|NCT00346216|144227282|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.61|STANDARD_ERROR_OF_MEAN|0.49||0.2105|TWO_SIDED|95.0|-0.34|1.56|||Mixed Models Analysis|||Change from baseline to Month 30 (ITT)||1.56|-0.34|0.2105
72353622|NCT00346216|144227282|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.51|STANDARD_ERROR_OF_MEAN|0.49||0.2909|TWO_SIDED|95.0|-0.44|1.46|||Mixed Models Analysis|||Change from baseline to Month 30 (ITT)||1.46|-0.44|0.2909
72353623|NCT00346216|144227282|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.09|STANDARD_ERROR_OF_MEAN|0.49||0.8459|TWO_SIDED|95.0|-0.86|1.05|||Mixed Models Analysis|||Change from baseline to Month 30 (ITT)||1.05|-0.86|0.8459
72353624|NCT00346216|144227282|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.81|STANDARD_ERROR_OF_MEAN|0.51||0.1116|TWO_SIDED|95.0|-0.19|1.8|||Mixed Models Analysis|||Change from baseline to Month 36 (ITT)||1.80|-0.19|0.1116
72353625|NCT00346216|144227282|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.51||0.9751|TWO_SIDED|95.0|-0.98|1.01|||Mixed Models Analysis|||Change from baseline to Month 36 (ITT)||1.01|-0.98|0.9751
72353626|NCT00346216|144227282|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.79|STANDARD_ERROR_OF_MEAN|0.51||0.1202|TWO_SIDED|95.0|-0.21|1.79|||Mixed Models Analysis|||Change from baseline to Month 36 (ITT)||1.79|-0.21|0.1202
72353627|NCT00346216|144227282|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.46|STANDARD_ERROR_OF_MEAN|0.52||0.3767|TWO_SIDED|95.0|-0.56|1.48|||Mixed Models Analysis|||Change from baseline to Month 42 (ITT)||1.48|-0.56|0.3767
72353628|NCT00346216|144227282|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.83|STANDARD_ERROR_OF_MEAN|0.52||0.1123|TWO_SIDED|95.0|-1.85|0.19|||Mixed Models Analysis|||Change from baseline to Month 42 (ITT)||0.19|-1.85|0.1123
72353629|NCT00346216|144227282|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.29|STANDARD_ERROR_OF_MEAN|0.52||0.0137|TWO_SIDED|95.0|0.26|2.31|||Mixed Models Analysis|||Change from baseline to Month 42 (ITT)||2.31|0.26|0.0137
72353630|NCT00346216|144227282|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.77|STANDARD_ERROR_OF_MEAN|0.36|<|0.0001|TWO_SIDED|95.0|1.07|2.47|||Mixed Models Analysis|||Change from Baseline to Month 1 (MITT)||2.47|1.07|<0.0001
72353631|NCT00346216|144227282|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.84|STANDARD_ERROR_OF_MEAN|0.36||0.0197|TWO_SIDED|95.0|0.13|1.54|||Mixed Models Analysis|||Change from Baseline to Month 1 (MITT)||1.54|0.13|0.0197
72353632|NCT00346216|144227282|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.93|STANDARD_ERROR_OF_MEAN|0.36||0.0094|TWO_SIDED|95.0|0.23|1.64|||Mixed Models Analysis|||Change from Baseline to Month 1 (MITT)||1.64|0.23|0.0094
72353633|NCT00346216|144227282|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.57|STANDARD_ERROR_OF_MEAN|0.37||0.1247|TWO_SIDED|95.0|-0.16|1.31|||Mixed Models Analysis|||Change from baseline to Month 2 (MITT)||1.31|-0.16|0.1247
72353634|NCT00346216|144227282|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.08|STANDARD_ERROR_OF_MEAN|0.37||0.8278|TWO_SIDED|95.0|-0.81|0.65|||Mixed Models Analysis|||Change from baseline to Month 2 (MITT)||0.65|-0.81|0.8278
72353635|NCT00346216|144227282|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.65|STANDARD_ERROR_OF_MEAN|0.37||0.0802|TWO_SIDED|95.0|-0.08|1.39|||Mixed Models Analysis|||Change from baseline to Month 2 (MITT)||1.39|-0.08|0.0802
72353636|NCT00346216|144227282|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.68|STANDARD_ERROR_OF_MEAN|0.39||0.0822|TWO_SIDED|95.0|-0.09|1.46|||Mixed Models Analysis|||Change from baseline to Month 4 (MITT)||1.46|-0.09|0.0822
72353637|NCT00346216|144227282|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.08|STANDARD_ERROR_OF_MEAN|0.39||0.8314|TWO_SIDED|95.0|-0.86|0.69|||Mixed Models Analysis|||Change from baseline to Month 4 (MITT)||0.69|-0.86|0.8314
72353638|NCT00346216|144227282|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.77|STANDARD_ERROR_OF_MEAN|0.39||0.0516|TWO_SIDED|95.0|-0.01|1.54|||Mixed Models Analysis|||Change from baseline to Month 4 (MITT)||1.54|-0.01|0.0516
72353639|NCT00346216|144227282|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.42|STANDARD_ERROR_OF_MEAN|0.42||0.3202|TWO_SIDED|95.0|-0.4|1.24|||Mixed Models Analysis|||Change from baseline to Month 8 (MITT)||1.24|-0.40|0.3202
72353640|NCT00346216|144227282|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.23|STANDARD_ERROR_OF_MEAN|0.42||0.5893|TWO_SIDED|95.0|-0.6|1.05|||Mixed Models Analysis|||Change from baseline to Month 8 (MITT)||1.05|-0.60|0.5893
72353641|NCT00346216|144227282|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.19|STANDARD_ERROR_OF_MEAN|0.42||0.651|TWO_SIDED|95.0|-0.63|1.01|||Mixed Models Analysis|||Change from baseline to Month 8 (MITT)||1.01|-0.63|0.6510
72353642|NCT00346216|144227282|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.76|STANDARD_ERROR_OF_MEAN|0.44||0.0796|TWO_SIDED|95.0|-0.09|1.62|||Mixed Models Analysis|||Change from baseline to Month 12 (MITT)||1.62|-0.09|0.0796
72353643|NCT00346216|144227282|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.29|STANDARD_ERROR_OF_MEAN|0.44||0.5061|TWO_SIDED|95.0|-0.57|1.15|||Mixed Models Analysis|||Change from baseline to Month 12 (MITT)||1.15|-0.57|0.5061
72353644|NCT00346216|144227282|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.47|STANDARD_ERROR_OF_MEAN|0.44||0.2796|TWO_SIDED|95.0|-0.38|1.33|||Mixed Models Analysis|||Change from baseline to Month 12 (MITT)||1.33|-0.38|0.2796
72353645|NCT00346216|144227282|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.19|STANDARD_ERROR_OF_MEAN|0.45||0.6725|TWO_SIDED|95.0|-0.69|1.08|||Mixed Models Analysis|||Change from baseline to Month 18 (MITT)||1.08|-0.69|0.6725
72353646|NCT00346216|144227282|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.21|STANDARD_ERROR_OF_MEAN|0.45||0.6381|TWO_SIDED|95.0|-1.1|0.67|||Mixed Models Analysis|||Change from baseline to Month 18 (MITT)||0.67|-1.10|0.6381
72353647|NCT00346216|144227282|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.4|STANDARD_ERROR_OF_MEAN|0.45||0.3737|TWO_SIDED|95.0|-0.49|1.29|||Mixed Models Analysis|||Change from baseline to Month 18 (MITT)||1.29|-0.49|0.3737
72353648|NCT00346216|144227282|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.47||0.9139|TWO_SIDED|95.0|-0.87|0.97|||Mixed Models Analysis|||Change from baseline to Month 24 (MITT)||0.97|-0.87|0.9139
72353649|NCT00346216|144227282|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.47||0.9998|TWO_SIDED|95.0|-0.92|0.92|||Mixed Models Analysis|||Change from baseline to Month 24 (MITT)||0.92|-0.92|0.9998
72353650|NCT00346216|144227282|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.47||0.9144|TWO_SIDED|95.0|-0.88|0.98|||Mixed Models Analysis|||Change from baseline to Month 24 (MITT)||0.98|-0.88|0.9144
72353651|NCT00346216|144227282|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.62|STANDARD_ERROR_OF_MEAN|0.51||0.225|TWO_SIDED|95.0|-0.38|1.61|||Mixed Models Analysis|||Change from baseline to Month 30 (MITT)||1.61|-0.38|0.2250
72353652|NCT00346216|144227282|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.55|STANDARD_ERROR_OF_MEAN|0.51||0.2758|TWO_SIDED|95.0|-0.44|1.55|||Mixed Models Analysis|||Change from baseline to Month 30 (MITT)||1.55|-0.44|0.2758
72353653|NCT00346216|144227282|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.06|STANDARD_ERROR_OF_MEAN|0.51||0.903|TWO_SIDED|95.0|-0.94|1.06|||Mixed Models Analysis|||Change from baseline to Month 30 (MITT)||1.06|-0.94|0.9030
72353654|NCT00346216|144227282|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.9|STANDARD_ERROR_OF_MEAN|0.53||0.091|TWO_SIDED|95.0|-0.14|1.94|||Mixed Models Analysis|||Change from baseline to Month 36 (MITT)||1.94|-0.14|0.0910
72353655|NCT00346216|144227282|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.16|STANDARD_ERROR_OF_MEAN|0.53||0.7668|TWO_SIDED|95.0|-0.88|1.2|||Mixed Models Analysis|||Change from baseline to Month 36 (MITT)||1.20|-0.88|0.7668
72353656|NCT00346216|144227282|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.74|STANDARD_ERROR_OF_MEAN|0.53||0.1653|TWO_SIDED|95.0|-0.31|1.78|||Mixed Models Analysis|||Change from baseline to Month 36 (MITT)||1.78|-0.31|0.1653
72353657|NCT00346216|144227282|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.43|STANDARD_ERROR_OF_MEAN|0.55||0.4323|TWO_SIDED|95.0|-0.65|1.52|||Mixed Models Analysis|||Change from baseline to Month 42 (MITT)||1.52|-0.65|0.4323
72353658|NCT00346216|144227282|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.81|STANDARD_ERROR_OF_MEAN|0.55||0.1439|TWO_SIDED|95.0|-1.89|0.28|||Mixed Models Analysis|||Change from baseline to Month 42 (MITT)||0.28|-1.89|0.1439
72353659|NCT00346216|144227282|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.24|STANDARD_ERROR_OF_MEAN|0.55||0.0251|TWO_SIDED|95.0|0.16|2.33|||Mixed Models Analysis|||Change from baseline to Month 42 (MITT)||2.33|0.16|0.0251
72353660|NCT00904813|144227283|NON_INFERIORITY|In the initial protocol treatment groups were deemed non-inferior if the upper limit of a two-sided 90% CI for the hazard ratio did not exceed 1.7. With a cumulative incidence of local recurrence at 15%, a sample size of 840 participants were determined to provide a power of 80%. However, due to lower recurrence rate, the trial was re-powered in the amendment 1999 to deem non-inferiority at an HR not exceeding 2.5 or 3.6 depending on the frequency of local recurrence.|Hazard Ratio (HR)|0.38||||0.52|TWO_SIDED|90.0|0.06|2.56||The threshold for statistical significance was p=0.05.|Log Rank|An overall p-value was calculated.|SRT was used as reference group. Estimation described above is for SRT-delay. For LRT-delay HR (90% CI) was 1.22 with lower limit: 0.33, and upper limit: 3.45.|The effect of treatment regimen on local recurrence as first event in the three-armed group comparison (n = 385) was estimated with proportional hazards regression, stratified by participating centre.||2.56|0.06|0.52
72353661|NCT00904813|144227283|NON_INFERIORITY|In the initial protocol treatment groups were deemed non-inferior if the upper limit of a two-sided 90% CI for the hazard ratio did not exceed 1.7. With a cumulative incidence of local recurrence at 15%, a sample size of 840 participants were determined to provide a power of 80%. However, due to lower recurrence rate, the trial was re-powered in the amendment 1999 to deem non-inferiority at an HR not exceeding 2.5 or 3.6 depending on the frequency of local recurrence.|Hazard Ratio (HR)|0.93||||0.92|TWO_SIDED|95.0|0.64|1.35||The threshold for statistical significance was p=0.05.|Log Rank|An overall p-value was calculated.|SRT was used as reference group (1.00). Estimation described above is for SRT-delay. For LRT-delay HR (95% CI) was 0.99 with lower limit: 0.68, and upper limit: 1.42.|The effect of treatment regimen on recurrence-free survival in the three armed randomisation comparison (n = 385) was estimated with proportional hazards regression, stratified by participating centre.||1.35|0.64|0.92
72353662|NCT00904813|144227283|NON_INFERIORITY|In the initial protocol treatment groups were deemed non-inferior if the upper limit of a two-sided 90% CI for the hazard ratio did not exceed 1.7. With a cumulative incidence of local recurrence at 15%, a sample size of 840 participants were determined to provide a power of 80%. However, due to lower recurrence rate, the trial was re-powered in the amendment 1999 to deem non-inferiority at an HR not exceeding 2.5 or 3.6 depending on the frequency of local recurrence.|Hazard Ratio (HR)|0.91||||0.59|TWO_SIDED|90.0|0.36|2.27||The threshold for statistical significance was p=0.05.|Log Rank||SRT was used as reference group (1.00). Estimation described above is for SRT-delay.|The effect of treatment regimen on local recurrence as first event in the pooled short-course RT comparison (n = 712) was estimated with proportional hazards regression, stratified by participating centre.||2.27|0.36|0.59
72353663|NCT00904813|144227283|NON_INFERIORITY|In the initial protocol treatment groups were deemed non-inferior if the upper limit of a two-sided 90% CI for the hazard ratio did not exceed 1.7. With a cumulative incidence of local recurrence at 15%, a sample size of 840 participants were determined to provide a power of 80%. However, due to lower recurrence rate, the trial was re-powered in the amendment 1999 to deem non-inferiority at an HR not exceeding 2.5 or 3.6 depending on the frequency of local recurrence.|Hazard Ratio (HR)|0.9||||0.39|TWO_SIDED|95.0|0.69|1.18||The threshold for statistical significance was p=0.05.|Log Rank||SRT was used as reference group. Estimation described above is for SRT-delay.|The effect of treatment regimen on recurrence-free survival in the pooled short-course RT comparison (n = 712) was estimated with proportional hazards regression, stratified by participating centre.||1.18|0.69|0.39
72353664|NCT00904813|144227284|SUPERIORITY||Odds Ratio (OR)|0.72||||0.289|TWO_SIDED|95.0|0.4|1.32||The threshold of statistical significance was p=0.05.|Regression, Logistic|Model was adjusted for sex, age over 75 years, type of surgery and ASA fitness grade.|Group B was used as the reference group.|The association between postoperative complications and short-course RT by overall treatment time was assessed using logistic regression analysis.||1.32|0.40|0.289
72353665|NCT00904813|144227284|SUPERIORITY||Odds Ratio (OR)|0.5||||0.009|TWO_SIDED|95.0|0.3|0.84||The threshold for statistical significance was p=0.05.|Regression, Logistic|Model was adjusted for sex, age over 75 years, type of surgery and ASA fitness grade.|Group B was used as the reference group.|The association between postoperative complications and short-course RT by overall treatment time was assessed using logistic regression analysis.||0.84|0.30|0.009
72353666|NCT00904813|144227284|SUPERIORITY||Odds Ratio (OR)|0.39|||<|0.001|TWO_SIDED|95.0|0.23|0.65||The threshold for statistical significance was p-value=0.05.|Regression, Logistic|Model was adjusted for sex, age over 75 years, type of surgery and ASA fitness grade.|Group B was used as the reference group.|The association between postoperative complications and short-course RT by overall treatment time was assessed using logistic regression analysis.||0.65|0.23|<0.001
72353667|NCT00904813|144227284|SUPERIORITY||Odds Ratio (OR)|1.58||||0.521|TWO_SIDED|95.0|0.39|6.37||The threshold for statistical significance was p-value = 0.05.|Regression, Logistic|Model was adjusted for sex, age over 75 years, type of surgery and ASA fitness grade.|Group E was used as the reference group.|The association between postoperative complications and long-course RT by overall treatment time was assessed using logistic regression analysis.||6.37|0.39|0.521
72353668|NCT00904813|144227285|SUPERIORITY||Hazard Ratio (HR)|0.51||||0.046|TWO_SIDED|95.0|0.26|0.99||The threshold for statistical significance was p=0.05.|Regression, Cox|Model adjusted for age, sex and type of surgery.|No pCR was used as reference group.|The association between pathological complete response (pCR), eg no signs of viable tumour or metastatic nodes (T0N0) and overall survival (OS) was assessed using Cox-regression model.||0.99|0.26|0.046
72353669|NCT02271698|144227293|SUPERIORITY_OR_OTHER|||||||0.052||||||6 hour pain at rest|t-test, 2 sided|||||||0.052
72353670|NCT02271698|144227293|SUPERIORITY_OR_OTHER|||||||0.064||||||6 hour pain with movement|t-test, 2 sided|||||||0.064
72353671|NCT02271698|144227293|SUPERIORITY_OR_OTHER|||||||0.139|||||||t-test, 2 sided|12 hour pain at rest||||||0.139
72353672|NCT02271698|144227293|SUPERIORITY_OR_OTHER|||||||0.35||||||12 hour pain at rest|t-test, 2 sided|||||||0.350
72353673|NCT02271698|144227293|SUPERIORITY_OR_OTHER|||||||0.021||||||18 hour pain at rest|t-test, 2 sided|||||||0.021
72353674|NCT02271698|144227293|SUPERIORITY_OR_OTHER|||||||0.198||||||18 hour pain with movement|t-test, 2 sided|||||||0.198
72353675|NCT02271698|144227293|SUPERIORITY_OR_OTHER|||||||0.806|||||||t-test, 2 sided|24 hour pain at rest||||||0.806
72353676|NCT02271698|144227293|SUPERIORITY_OR_OTHER|||||||0.228||||||24 hour pain with movement|t-test, 2 sided|||||||0.228
72353677|NCT02271698|144227293|SUPERIORITY_OR_OTHER|||||||0.457||||||36 hour pain at rest|t-test, 2 sided|||||||0.457
72353678|NCT02271698|144227293|SUPERIORITY_OR_OTHER|||||||0.394||||||36 hour pain with movement|t-test, 2 sided|||||||0.394
72353679|NCT02271698|144227294|SUPERIORITY_OR_OTHER|||||||0.181||||||6 hours|t-test, 2 sided|||||||0.181
72353680|NCT02271698|144227294|SUPERIORITY_OR_OTHER|||||||0.364||||||12 hours|t-test, 2 sided|||||||0.364
72353681|NCT02271698|144227294|SUPERIORITY_OR_OTHER|||||||0.605|||||||t-test, 2 sided|18 hours||||||0.605
72353682|NCT02271698|144227294|SUPERIORITY_OR_OTHER|||||||0.733|||||||t-test, 2 sided|24 hours||||||0.733
72353683|NCT02271698|144227294|SUPERIORITY_OR_OTHER|||||||0.6||||||36 hours|t-test, 2 sided|||||||0.600
72353684|NCT03985761|144227311|SUPERIORITY|||||||0.182|||||||ANOVA|||||||.182
72353685|NCT03985761|144227312|SUPERIORITY|||||||0.296|||||||ANOVA|||||||.296
72353686|NCT03985761|144227313|SUPERIORITY|||||||0.483|||||||ANOVA|||||||.483
72353687|NCT03985761|144227314|SUPERIORITY|||||||0.995|||||||ANOVA|||||||.995
72353688|NCT03985761|144227315|SUPERIORITY|||||||0.22|||||||ANOVA|||||||.220
72353689|NCT03985761|144227316|SUPERIORITY|||||||0.538|||||||ANOVA|||||||.538
72353690|NCT03985761|144227319|SUPERIORITY|||||||0.121|||||||ANOVA|||||||.121
72353691|NCT01755234|144227321|SUPERIORITY_OR_OTHER|||||||0.97|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.97
72353692|NCT01755234|144227322|SUPERIORITY_OR_OTHER|||||||0.96|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.96
72353693|NCT01755234|144227323|SUPERIORITY_OR_OTHER|||||||0.96|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.96
72353694|NCT01755234|144227324|SUPERIORITY_OR_OTHER|||||||0.84|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.84
72353695|NCT04862065|144227369|SUPERIORITY||Clinical Specificity (%)|99.96|||||TWO_SIDED|95.0|99.92|99.99|||Binomial Distribution|Specificity sample size is a minimum of 15,000 donors.||||99.99|99.92|
72353696|NCT04862065|144227370|OTHER|95% Confidence Interval provided|Point Estimate|100.0|||||TWO_SIDED|95.0|99.09|100.0|||Sensitivity|||||100.00|99.09|
72353697|NCT04862065|144227371|OTHER|95% Confidence Interval provided.|Point Estimate|100.0|||||TWO_SIDED|95.0|94.87|100.0|||Sensitivity|||Sensitivity||100.00|94.87|
72353698|NCT03170661|144227376|SUPERIORITY|||||||0.94|||||||GEEGLM|Effects of GEEGLM covariates: surgeon, p = 0.24; surgery length, p= 0.73 and body mass index, p= 0.22).||||||0.94
72353699|NCT03001557|144227385|SUPERIORITY||Least square mean (LSM) difference|3.177||||0.1099|TWO_SIDED|95.0|-0.741|7.096||Based on a mixed model for repeated measure (MMRM) analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM|||||7.096|-0.741|0.1099
72353700|NCT03001557|144227385|SUPERIORITY||LSM Difference|2.802||||0.1576|TWO_SIDED|95.0|-1.119|6.723||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM|||||6.723|-1.119|0.1576
72353701|NCT03001557|144227385|SUPERIORITY||LSM Difference|-0.96||||0.616|TWO_SIDED|95.0|-4.777|2.857||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM|||||2.857|-4.777|0.6160
72353702|NCT03001557|144227385|SUPERIORITY||LSM Difference|0.713||||0.7135|TWO_SIDED|95.0|-3.16|4.585||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM|||||4.585|-3.160|0.7135
72353703|NCT03001557|144227389|SUPERIORITY||LSM Difference|-5.098||||0.1582|TWO_SIDED|95.0|-12.24|2.045||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM|||||2.045|-12.240|0.1582
72353704|NCT03001557|144227389|SUPERIORITY||LSM Difference|-6.105||||0.0961|TWO_SIDED|95.0|-13.332|1.122||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM|||||1.122|-13.332|0.0961
72353705|NCT03001557|144227389|SUPERIORITY||LSM Difference|0.68||||0.8449|TWO_SIDED|95.0|-6.262|7.623||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM|||||7.623|-6.262|0.8449
72353706|NCT03001557|144227389|SUPERIORITY||LSM Difference|-3.14||||0.3747|TWO_SIDED|95.0|-10.178|3.897||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM|||||3.897|-10.178|0.3747
72353707|NCT03001557|144227393|SUPERIORITY||LSM Difference|1.932||||0.3966|TWO_SIDED|95.0|-2.601|6.465||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM|||||6.465|-2.601|0.3966
72353708|NCT03001557|144227393|SUPERIORITY||LSM Difference|3.386||||0.1381|TWO_SIDED|95.0|-1.125|7.897||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM|||||7.897|-1.125|0.1381
72353709|NCT03001557|144227393|SUPERIORITY||LSM Difference|1.337||||0.5487|TWO_SIDED|95.0|-3.104|5.778||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM|||||5.778|-3.104|0.5487
72353710|NCT03001557|144227393|SUPERIORITY||LSM Difference|4.32||||0.0581|TWO_SIDED|95.0|-0.153|8.793||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM|||||8.793|-0.153|0.0581
72353711|NCT03001557|144227397|SUPERIORITY||LSM Difference|-3.437||||0.1777|TWO_SIDED|95.0|-8.481|1.608||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM|||||1.608|-8.481|0.1777
72353712|NCT03001557|144227397|SUPERIORITY||LSM Difference|1.458||||0.563|TWO_SIDED|95.0|-3.564|6.479||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM|||||6.479|-3.564|0.5630
72353713|NCT03001557|144227397|SUPERIORITY||LSM Difference|-4.994||||0.0482|TWO_SIDED|95.0|-9.946|-0.041||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM|||||-0.041|-9.946|0.0482
72353714|NCT03001557|144227397|SUPERIORITY||LSM Difference|-2.593||||0.3036|TWO_SIDED|95.0|-7.599|2.413||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM|||||2.413|-7.599|0.3036
72353715|NCT03001557|144227401|SUPERIORITY||LSM Difference|4.845||||0.1991|TWO_SIDED|95.0|-2.624|12.313||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM|||||12.313|-2.624|0.1991
72353716|NCT03001557|144227401|SUPERIORITY||LSM Difference|-3.872||||0.2982|TWO_SIDED|95.0|-11.263|3.518||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM|||||3.518|-11.263|0.2982
72353717|NCT03001557|144227401|SUPERIORITY||LSM Difference|6.776||||0.0664|TWO_SIDED|95.0|-0.474|14.025||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM|||||14.025|-0.474|0.0664
72353718|NCT03001557|144227401|SUPERIORITY||LSM Difference|3.017||||0.4148|TWO_SIDED|95.0|-4.344|10.379||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM|||||10.379|-4.344|0.4148
72353719|NCT03001557|144227405|SUPERIORITY||LSM Difference|0.063||||0.9599|TWO_SIDED|95.0|-2.452|2.579||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM|||||2.579|-2.452|0.9599
72353720|NCT03001557|144227405|SUPERIORITY||LSM Difference|-0.238||||0.8541|TWO_SIDED|95.0|-2.817|2.342||Based on a MMRM analysis adjusted for baseline value, country, Visit and treatment by Visit interaction.|MMRM|||||2.342|-2.817|0.8541
72353721|NCT03001557|144227405|SUPERIORITY||LSM Difference|-0.293||||0.8117|TWO_SIDED|95.0|-2.745|2.16||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM|||||2.160|-2.745|0.8117
72353722|NCT03001557|144227405|SUPERIORITY||LSM Difference|-1.557||||0.2274|TWO_SIDED|95.0|-4.113|1.0||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM|||||1.000|-4.113|0.2274
72353723|NCT03001557|144227409|SUPERIORITY||LSM Difference|0.086||||0.2421|TWO_SIDED|95.0|-0.06|0.232||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM|||||0.232|-0.060|0.2421
72353724|NCT03001557|144227409|SUPERIORITY||LSM Difference|-0.012||||0.8661|TWO_SIDED|95.0|-0.155|0.131||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM|||||0.131|-0.155|0.8661
72353725|NCT03001557|144227409|SUPERIORITY||LSM Difference|0.057||||0.4251|TWO_SIDED|95.0|-0.085|0.199||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM|||||0.199|-0.085|0.4251
72353726|NCT03001557|144227409|SUPERIORITY||LSM Difference|0.025||||0.7248|TWO_SIDED|95.0|-0.116|0.166||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM|||||0.166|-0.116|0.7248
72353727|NCT03001557|144227413|SUPERIORITY||LSM Difference|-0.032||||0.2991|TWO_SIDED|95.0|-0.094|0.029||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM|||||0.029|-0.094|0.2991
72353728|NCT03001557|144227413|SUPERIORITY||LSM Difference|0.033||||0.2861|TWO_SIDED|95.0|-0.028|0.095||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM|||||0.095|-0.028|0.2861
72353729|NCT03001557|144227413|SUPERIORITY||LSM Difference|-0.052||||0.0938|TWO_SIDED|95.0|-0.113|0.009||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM|||||0.009|-0.113|0.0938
72353730|NCT03001557|144227413|SUPERIORITY||LSM Difference|0.005||||0.8618|TWO_SIDED|95.0|-0.055|0.066||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM|||||0.066|-0.055|0.8618
72353731|NCT03001557|144227417|SUPERIORITY||LSM Difference|-389.873||||0.0294|TWO_SIDED|95.0|-739.177|-40.569||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM|||||-40.569|-739.177|0.0294
72353732|NCT03001557|144227417|SUPERIORITY||LSM Difference|-402.994||||0.0243|TWO_SIDED|95.0|-751.67|-54.319||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM|||||-54.319|-751.670|0.0243
72353733|NCT03001557|144227417|SUPERIORITY||LSM Difference|-141.026||||0.4209|TWO_SIDED|95.0|-489.805|207.752||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM|||||207.752|-489.805|0.4209
72353734|NCT03001557|144227417|SUPERIORITY||LSM Difference|-367.845||||0.0398|TWO_SIDED|95.0|-717.87|-17.82||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM|||||-17.820|-717.870|0.0398
72353735|NCT03001557|144227421|SUPERIORITY||LSM Difference|-1276.18||||0.1162|TWO_SIDED|95.0|-2878.587|326.226||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM|||||326.226|-2878.587|0.1162
72353736|NCT03001557|144227421|SUPERIORITY||LSM Difference|227.464||||0.7781|TWO_SIDED|95.0|-1382.85|1837.777||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM|||||1837.777|-1382.850|0.7781
72353737|NCT03001557|144227421|SUPERIORITY||LSM Difference|-620.581||||0.4255|TWO_SIDED|95.0|-2170.342|929.179||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM|||||929.179|-2170.342|0.4255
72353738|NCT03001557|144227421|SUPERIORITY||LSM Difference|-577.82||||0.4672|TWO_SIDED|95.0|-2160.337|1004.697||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM|||||1004.697|-2160.337|0.4672
72353739|NCT03001557|144227425|SUPERIORITY||LSM Difference|-839.088||||0.2984|TWO_SIDED|95.0|-2440.854|762.678||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM|||||762.678|-2440.854|0.2984
72353740|NCT03001557|144227425|SUPERIORITY||LSM Difference|651.922||||0.4218|TWO_SIDED|95.0|-962.835|2266.678||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM|||||2266.678|-962.835|0.4218
72353741|NCT03001557|144227425|SUPERIORITY||LSM Difference|-447.245||||0.5655|TWO_SIDED|95.0|-1998.44|1103.95||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM|||||1103.950|-1998.440|0.5655
72353742|NCT03001557|144227425|SUPERIORITY||LSM Difference|-130.603||||0.8686|TWO_SIDED|95.0|-1706.478|1445.272||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM|||||1445.272|-1706.478|0.8686
72353743|NCT03001557|144227429|SUPERIORITY||LSM Difference|0.02||||0.4638|TWO_SIDED|95.0|-0.034|0.074||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM|||||0.074|-0.034|0.4638
72353744|NCT03001557|144227429|SUPERIORITY||LSM Difference|0.06||||0.0322|TWO_SIDED|95.0|0.005|0.115||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM|||||0.115|0.005|0.0322
72353745|NCT03001557|144227429|SUPERIORITY||LSM Difference|0.003||||0.9144|TWO_SIDED|95.0|-0.051|0.056||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM|||||0.056|-0.051|0.9144
72353746|NCT03001557|144227429|SUPERIORITY||LSM Difference|0.057||||0.0364|TWO_SIDED|95.0|0.004|0.11||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction|MMRM|||||0.110|0.004|0.0364
72353747|NCT01794000|144227435|SUPERIORITY_OR_OTHER_LEGACY||Rate Ratio|0.83||||0.117|TWO_SIDED|95.0|0.66|1.05|||Andersen-Gill model||The rate ratio and 2-sided 95% Confidence Interval (CI) were estimated from the Andersen-Gill model.|The time to a recurrent episode of VOC was analyzed using Andersen-Gill model. A robust variance estimate was used, with treatment, hydroxyurea use at baseline and age group included as factors in the model.||1.05|0.66|.117
72353748|NCT01794000|144227436|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-0.242||||0.912|TWO_SIDED|95.0|-4.564|4.079||Mixed Model Repeated Measures (MMRM) included fixed effects of treatment, baseline value of the pain-diary outcome measure, hydroxyurea use, age group, time and treatment-by-time interaction.|Mixed Models Analysis||The Least Square (LS) Mean difference of prasugrel minus placebo and the corresponding 2-sided 95% CI were estimated from the MMRM model.|||4.079|-4.564|.912
72353749|NCT01794000|144227437|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|0.0968||||0.365|TWO_SIDED|95.0|-0.1132|0.3068||MMRM model included fixed effects of treatment, baseline value of the pain-diary outcome measure, hydroxyurea use, age group, time and treatment-by-time interaction.|Mixed Models Analysis||The LS Mean difference of prasugrel minus placebo and the corresponding 2-sided 95% CI were estimated from the MMRM model.|||0.3068|-0.1132|.365
72353750|NCT01794000|144227438|SUPERIORITY_OR_OTHER_LEGACY||Rate Ratio|0.82||||0.109|TWO_SIDED|95.0|0.65|1.04||The time to a recurrent episode of painful crisis was analyzed using Andersen-Gill model.|Andersen-Gill Model|A robust variance estimate was used, with treatment, hydroxyurea use at baseline and age group included as factors in the model.|The rate ratio and 2-sided 95% CI were estimated from the Andersen-Gill model.|||1.04|0.65|.109
72353751|NCT01794000|144227439|SUPERIORITY_OR_OTHER_LEGACY||Rate Ratio|0.94||||0.759|TWO_SIDED|95.0|0.65|1.37||The time to a recurrent episode of hospitalization was analyzed using Andersen-Gill model.|Andersen-Gill model|A robust variance estimate was used, with treatment, hydroxyurea use at baseline and age group included as factors in the model.|The rate ratio and 2-sided 95% CI were estimated from the Andersen-Gill model.|||1.37|0.65|.759
72353752|NCT01794000|144227440|SUPERIORITY_OR_OTHER_LEGACY||Rate Ratio|0.96||||0.916|TWO_SIDED|95.0|0.48|1.93||The time to a recurrent episode of acute chest syndrome was analyzed using Andersen-Gill model.|Andersen-Gill model|A robust variance estimate was used, with treatment, hydroxyurea use at baseline and age group included as factors in the model.|The rate ratio and 2-sided 95% CI were estimated from the Andersen-Gill model.|||1.93|0.48|.916
72353753|NCT01794000|144227441|SUPERIORITY_OR_OTHER_LEGACY||Rate Ratio|1.17||||0.544|TWO_SIDED|95.0|0.71|1.91||The time to a recurrent episode of RBC transfusion was analyzed using Andersen-Gill model.|Andersen-Gill model|A robust variance estimate was used, with treatment, hydroxyurea use at baseline and age group included as factors in the model.|The rate ratio and 2-sided 95% CI were estimated from the Andersen-Gill model.|||1.91|0.71|.544
72353754|NCT01794000|144227442|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|1.513||||0.602|TWO_SIDED|95.0|-4.186|7.213||The MMRM model included the fixed effects of treatment, the baseline value of the pain-diary measure, hydroxyurea use, age group, time and treatment-by-time interaction.|Mixed Models Analysis||The Least Square Mean difference of prasugrel minus placebo and the corresponding 2-sided 95% CI were estimated from the MMRM model.|||7.213|-4.186|.602
72353755|NCT01794000|144227443|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|1.272||||0.459|TWO_SIDED|95.0|-2.109|4.652||The MMRM model included the fixed effects of treatment, the baseline value of the pain-diary measure, hydroxyurea use, age group, time and treatment-by-time interaction.|Mixed Models Analysis||The LS Mean difference of prasugrel minus placebo and the corresponding 2-sided 95% CI were estimated from the MMRM model.|||4.652|-2.109|.459
72353756|NCT01794000|144227445|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|0.94||||0.662|TWO_SIDED|95.0|-3.31|5.19||The ANCOVA model included the factors of treatment, hydroxyurea use, age group, and length of follow-up.|ANCOVA||The LS Mean difference of prasugrel minus placebo and 2-sided 95% CI were estimated from the ANCOVA model.|||5.19|-3.31|.662
72353757|NCT01794000|144227446|SUPERIORITY_OR_OTHER_LEGACY|||||||0.317|||||||Log Rank|A stratified log-rank test were performed with hydroxyurea use and age group as the stratification factors.||Time from Randomization to the First VOC||||.317
72353758|NCT01794000|144227446|SUPERIORITY_OR_OTHER_LEGACY|||||||0.133|||||||Log Rank|A stratified log-rank test were performed with hydroxyurea use and age group as the stratification factors.||Time from Randomization to the Second VOC||||.133
72353759|NCT01794000|144227447|SUPERIORITY_OR_OTHER_LEGACY|||||||0.638|||||||Fisher Exact|||||||.638
72353760|NCT02365649|144227460|SUPERIORITY||Adjusted risk difference from placebo|9.9||||0.056|TWO_SIDED|95.0|-0.3|20.1||Statistical significance was prespecified at α = 0.1. Based on Cochran-Mantel-Haenszel (CMH) test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||20.1|-0.3|0.056
72353761|NCT02365649|144227460|SUPERIORITY||Adjusted risk difference from placebo|7.4||||0.108|TWO_SIDED|95.0|-1.6|16.4||Statistical significance was prespecified at α = 0.1. Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||16.4|-1.6|0.108
72353762|NCT02365649|144227460|SUPERIORITY||Adjusted risk difference from placebo|7.7||||0.099|TWO_SIDED|95.0|-1.5|16.8||Statistical significance was prespecified at α = 0.1. Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||16.8|-1.5|0.099
72353763|NCT02365649|144227460|SUPERIORITY||Adjusted risk difference from placebo|21.0||||0.004|TWO_SIDED|95.0|6.8|35.2||Statistical significance was prespecified at α = 0.1. Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||35.2|6.8|0.004
72353764|NCT02365649|144227460|SUPERIORITY||Adjusted risk difference from placebo|13.6||||0.025|TWO_SIDED|95.0|1.8|25.5||Statistical significance was prespecified at α = 0.1. Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||25.5|1.8|0.025
72353765|NCT02365649|144227461|SUPERIORITY||Adjusted risk difference from placebo|2.5||||0.74|TWO_SIDED|95.0|-12.3|17.3||Statistical significance was prespecified at α = 0.1. Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||17.3|-12.3|0.74
72353766|NCT02365649|144227461|SUPERIORITY||Adjusted risk difference from placebo|16.2||||0.082|TWO_SIDED|95.0|-2.0|34.3||Statistical significance was prespecified at α = 0.1. Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||34.3|-2.0|0.082
72353767|NCT02365649|144227461|SUPERIORITY||Adjusted risk difference from placebo|0.5||||0.952|TWO_SIDED|95.0|-14.1|15.0||Statistical significance was prespecified at α = 0.1. Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||15.0|-14.1|0.952
72353768|NCT02365649|144227461|SUPERIORITY||Adjusted risk difference from placebo|11.2||||0.205|TWO_SIDED|95.0|-6.1|28.5||Statistical significance was prespecified at α = 0.1. Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||28.5|-6.1|0.205
72353769|NCT02365649|144227461|SUPERIORITY||Adjusted risk difference from placebo|4.1||||0.607|TWO_SIDED|95.0|-11.5|19.6||Statistical significance was prespecified at α = 0.1. Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||19.6|-11.5|0.607
72353770|NCT02365649|144227462|SUPERIORITY||Adjusted risk difference from placebo|5.2||||0.564|TWO_SIDED|95.0|-12.5|22.9||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||22.9|-12.5|0.564
72353771|NCT02365649|144227462|SUPERIORITY||Adjusted risk difference from placebo|12.0||||0.221|TWO_SIDED|95.0|-7.2|31.2||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||31.2|-7.2|0.221
72353772|NCT02365649|144227462|SUPERIORITY||Adjusted risk difference from placebo|22.2||||0.036|TWO_SIDED|95.0|1.4|43.0||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||43|1.4|0.036
72353773|NCT02365649|144227462|SUPERIORITY||Adjusted risk difference from placebo|13.4||||0.179|TWO_SIDED|95.0|-6.2|33.1||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||33.1|-6.2|0.179
72353774|NCT02365649|144227462|SUPERIORITY||Adjusted risk difference from placebo|3.9||||0.677|TWO_SIDED|95.0|-14.3|22.0||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||22|-14.3|0.677
72353775|NCT02365649|144227463|SUPERIORITY||Adjusted risk difference from placebo|10.4||||0.363|TWO_SIDED|95.0|-12.0|32.9||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||32.9|-12|0.363
72353776|NCT02365649|144227463|SUPERIORITY||Adjusted risk difference from placebo|17.3||||0.137|TWO_SIDED|95.0|-5.5|40.0||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||40|-5.5|0.137
72353777|NCT02365649|144227463|SUPERIORITY||Adjusted risk difference from placebo|7.5||||0.512|TWO_SIDED|95.0|-14.9|29.9||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||29.9|-14.9|0.512
72353778|NCT02365649|144227463|SUPERIORITY||Adjusted risk difference from placebo|25.0||||0.035|TWO_SIDED|95.0|-1.8|48.2||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||48.2|-1.8|0.035
72353779|NCT02365649|144227463|SUPERIORITY||Adjusted risk difference from placebo|12.5||||0.29|TWO_SIDED|95.0|-10.7|35.6||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||35.6|-10.7|0.29
72353780|NCT02365649|144227464|SUPERIORITY||Adjusted risk difference from placebo|-0.9||||0.896|TWO_SIDED|95.0|-15.0|13.1||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||13.1|-15.0|0.896
72353781|NCT02365649|144227464|SUPERIORITY||Adjusted risk difference from placebo|18.6||||0.05|TWO_SIDED|95.0|0.0|37.3||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||37.3|0.0|0.05
72353782|NCT02365649|144227464|SUPERIORITY||Adjusted risk difference from placebo|3.0||||0.702|TWO_SIDED|95.0|-12.4|18.4||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||18.4|-12.4|0.702
72353783|NCT02365649|144227464|SUPERIORITY||Adjusted risk difference from placebo|14.3||||0.117|TWO_SIDED|95.0|-3.6|32.2||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||32.2|-3.6|0.117
72353784|NCT02365649|144227464|SUPERIORITY||Adjusted risk difference from placebo|-2.4||||0.736|TWO_SIDED|95.0|-16.4|11.6||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||11.6|-16.4|0.736
72353785|NCT02365649|144227465|SUPERIORITY||Adjusted risk difference from placebo|2.9||||0.276|TWO_SIDED|95.0|-2.3|8.1||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||8.1|-2.3|0.276
72353786|NCT02365649|144227465|SUPERIORITY||Adjusted risk difference from placebo|4.9||||0.195|TWO_SIDED|95.0|-2.5|12.4||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||12.4|-2.5|0.195
72353787|NCT02365649|144227465|SUPERIORITY||Adjusted risk difference from placebo|2.6||||0.355|TWO_SIDED|95.0|-2.9|8.0||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||8.0|-2.9|0.355
72353788|NCT02365649|144227465|SUPERIORITY||Adjusted risk difference from placebo|7.7||||0.099|TWO_SIDED|95.0|-1.5|16.8||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||16.8|-1.5|0.099
72353789|NCT02365649|144227465|SUPERIORITY||Adjusted risk difference from placebo|5.2||||0.185|TWO_SIDED|95.0|-2.5|12.9||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||12.9|-2.5|0.185
72353790|NCT02365649|144227466|SUPERIORITY||Adjusted risk difference from placebo|13.2||||0.05|TWO_SIDED|95.0|0.0|26.5||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||26.5|0.0|0.05
72353791|NCT02365649|144227466|SUPERIORITY||Adjusted risk difference from placebo|29.5||||0.001|TWO_SIDED|95.0|11.9|47.1||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||47.1|11.9|0.001
72353792|NCT02365649|144227466|SUPERIORITY||Adjusted risk difference from placebo|25.2||||0.003|TWO_SIDED|95.0|8.5|42.0||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||42.0|8.5|0.003
72353793|NCT02365649|144227466|SUPERIORITY||Adjusted risk difference from placebo|36.5|||<|0.001|TWO_SIDED|95.0|17.6|55.4||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||55.4|17.6|< 0.001
72353794|NCT02365649|144227466|SUPERIORITY||Adjusted risk difference from placebo|32.0|||<|0.001|TWO_SIDED|95.0|13.9|50.2||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||50.2|13.9|< 0.001
72353795|NCT02365649|144227467|SUPERIORITY||Adjusted risk difference from placebo|10.5||||0.243|TWO_SIDED|95.0|-7.2|28.2||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||28.2|-7.2|0.243
72353796|NCT02365649|144227467|SUPERIORITY||Adjusted risk difference from placebo|29.1||||0.006|TWO_SIDED|95.0|8.3|49.9||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||49.9|8.3|0.006
72353797|NCT02365649|144227467|SUPERIORITY||Adjusted risk difference from placebo|24.2||||0.017|TWO_SIDED|95.0|4.4|44.1||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||44.1|4.4|0.017
72353798|NCT02365649|144227467|SUPERIORITY||Adjusted risk difference from placebo|36.5|||<|0.001|TWO_SIDED|95.0|14.8|58.1||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||58.1|14.8|< 0.001
72353799|NCT02365649|144227467|SUPERIORITY||Adjusted risk difference from placebo|36.8|||<|0.001|TWO_SIDED|95.0|15.2|58.3||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||58.3|15.2|< 0.001
72353800|NCT02365649|144227468|SUPERIORITY||Adjusted risk difference from placebo|10.5||||0.353|TWO_SIDED|95.0|-11.7|32.7||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||32.7|-11.7|0.353
72353801|NCT02365649|144227468|SUPERIORITY||Adjusted risk difference from placebo|22.7||||0.05|TWO_SIDED|95.0|0.0|45.5||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||45.5|0.0|0.05
72353802|NCT02365649|144227468|SUPERIORITY||Adjusted risk difference from placebo|12.5||||0.268|TWO_SIDED|95.0|-9.6|34.6||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||34.6|-9.6|0.268
72353803|NCT02365649|144227468|SUPERIORITY||Adjusted risk difference from placebo|28.0||||0.018|TWO_SIDED|95.0|4.8|51.2||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||51.2|4.8|0.018
72353804|NCT02365649|144227468|SUPERIORITY||Adjusted risk difference from placebo|14.9||||0.204|TWO_SIDED|95.0|-8.1|37.8||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||37.8|-8.1|0.204
72353805|NCT02365649|144227469|SUPERIORITY||Adjusted risk difference from placebo|10.0||||0.421|TWO_SIDED|95.0|-14.4|34.4||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||34.4|-14.4|0.421
72353806|NCT02365649|144227469|SUPERIORITY||Adjusted risk difference from placebo|11.5||||0.371|TWO_SIDED|95.0|-13.8|36.8||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||36.8|-13.8|0.371
72353807|NCT02365649|144227469|SUPERIORITY||Adjusted risk difference from placebo|9.2||||0.445|TWO_SIDED|95.0|-14.4|32.8||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||32.8|-14.4|0.445
72353808|NCT02365649|144227469|SUPERIORITY||Adjusted risk difference from placebo|19.5||||0.198|TWO_SIDED|95.0|-10.2|49.3||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||49.3|-10.2|0.198
72353809|NCT02365649|144227469|SUPERIORITY||Adjusted risk difference from placebo|5.0||||0.654|TWO_SIDED|95.0|-17.0|27.0||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||27.0|-17.0|0.654
72353810|NCT02365649|144227470|SUPERIORITY||Adjusted risk difference from placebo|18.7||||0.093|TWO_SIDED|95.0|-3.1|40.5||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||40.5|-3.1|0.093
72353811|NCT02365649|144227470|SUPERIORITY||Adjusted risk difference from placebo|13.5||||0.176|TWO_SIDED|95.0|-6.1|33.1||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||33.1|-6.1|0.176
72353812|NCT02365649|144227470|SUPERIORITY||Adjusted risk difference from placebo|35.9||||0.017|TWO_SIDED|95.0|6.3|65.5||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||65.5|6.3|0.017
72353813|NCT02365649|144227470|SUPERIORITY||Adjusted risk difference from placebo|26.1||||0.044|TWO_SIDED|95.0|0.7|51.5|||Cochran-Mantel-Haenszel|||||51.5|0.7|0.044
72353814|NCT02365649|144227470|SUPERIORITY||Adjusted risk difference from placebo|13.1||||0.121|TWO_SIDED|95.0|-3.5|29.6||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||29.6|-3.5|0.121
72353815|NCT02365649|144227471|SUPERIORITY||Adjusted risk difference from placebo|3.4||||0.564|TWO_SIDED|95.0|-8.1|14.9||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||14.9|-8.1|0.564
72353816|NCT02365649|144227471|SUPERIORITY||Adjusted risk difference from placebo|3.4||||0.584|TWO_SIDED|95.0|-8.8|15.7||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||15.7|-8.8|0.584
72353817|NCT02365649|144227471|SUPERIORITY||Adjusted risk difference from placebo|8.7||||0.326|TWO_SIDED|95.0|-8.7|26.1||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||26.1|-8.7|0.326
72353818|NCT02365649|144227472|SUPERIORITY||Adjusted risk difference from placebo|12.2||||0.195|TWO_SIDED|95.0|-6.2|30.7||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||30.7|-6.2|0.195
72353819|NCT02365649|144227472|SUPERIORITY||Adjusted risk difference from placebo|17.9||||0.116|TWO_SIDED|95.0|-4.4|40.1||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||40.1|-4.4|0.116
72353820|NCT02365649|144227472|SUPERIORITY||Adjusted risk difference from placebo|12.8||||0.178|TWO_SIDED|95.0|-5.8|31.5||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||31.5|-5.8|0.178
72353821|NCT02365649|144227472|SUPERIORITY||Adjusted risk difference from placebo|30.4||||0.031|TWO_SIDED|95.0|2.8|58.0||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||58.0|2.8|0.031
72429207|NCT01058863|144369415|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|33.47|STANDARD_ERROR_OF_MEAN|3.69|<|0.0001|TWO_SIDED|95.0|26.21|40.74||Significance at the 0.05 level.|ANOVA|Fixed effects of baseline PPFEV1 as a covariate, sequence, treatment group, period, and center, and random effect for subject within sequence.||Of interest was the mean difference between each active group and placebo at each dose level. Analyses were performed at the 2-sided 0.05 significance level in this sequence: Albuterol Spiromax 180 mcg versus placebo; Albuterol Spiromax 90 mcg versus placebo, ProAir HFA 180 mcg versus placebo, and ProAir HFA 90 mcg versus placebo. If a test was not significant, no further tests were done. This sequential procedure preserved the error rate for the family of tests at the 0.05 level.||40.74|26.21|<0.0001
72353822|NCT02365649|144227472|SUPERIORITY||Adjusted risk difference from placebo|13.1||||0.121|TWO_SIDED|95.0|-3.5|29.6||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||29.6|-3.5|0.121
72353823|NCT02365649|144227473|SUPERIORITY||Adjusted risk difference from placebo|6.8||||0.392|TWO_SIDED|95.0|-8.7|22.2||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||22.2|-8.7|0.392
72353824|NCT02365649|144227473|SUPERIORITY||Adjusted risk difference from placebo|3.4||||0.584|TWO_SIDED|95.0|-8.8|15.7||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||15.7|-8.8|0.584
72353825|NCT02365649|144227473|SUPERIORITY||Adjusted risk difference from placebo|13.0||||0.199|TWO_SIDED|95.0|-6.8|32.9||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||32.9|-6.8|0.199
72353826|NCT02365649|144227473|SUPERIORITY||Adjusted risk difference from placebo|6.9||||0.439|TWO_SIDED|95.0|-10.6|24.5||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||24.5|-10.6|0.439
72353827|NCT02365649|144227474|SUPERIORITY||LS Mean Difference|-103.9||||0.788|TWO_SIDED|95.0|-865.69|657.87||P value for test of difference using the repeated measure model including treatment, Baseline disease severity (SES-CD \< 15 and ≥ 15), week, Baseline, interaction of treatment and week.|mixed-effect model repeated measure|||Week 4||657.87|-865.69|0.788
72353828|NCT02365649|144227474|SUPERIORITY||LS Mean Difference|-364.3||||0.325|TWO_SIDED|95.0|-1092.83|364.29||P value for test of difference using the repeated measure model including treatment, Baseline disease severity (SES-CD \< 15 and ≥ 15), week, Baseline, interaction of treatment and week.|mixed-effect model repeated measure|||Week 4||364.29|-1092.83|0.325
72353829|NCT02365649|144227474|SUPERIORITY||LS Mean Difference|-926.2||||0.015|TWO_SIDED|95.0|-1672.78|-179.63||P value for test of difference using the repeated measure model including treatment, Baseline disease severity (SES-CD \< 15 and ≥ 15), week, Baseline, interaction of treatment and week.|mixed-effect model repeated measure|||||-179.63|-1672.78|0.015
72353830|NCT02365649|144227474|SUPERIORITY||LS Mean Difference|-763.1||||0.053|TWO_SIDED|95.0|-1534.52|8.39||P value for test of difference using the repeated measure model including treatment, Baseline disease severity (SES-CD \< 15 and ≥ 15), week, Baseline, interaction of treatment and week.|mixed-effect model repeated measure|||Week 4||8.39|-1534.52|0.053
72353831|NCT02365649|144227474|SUPERIORITY||LS Mean Difference|-359.5||||0.352|TWO_SIDED|95.0|-1119.52|400.56||P value for test of difference using the repeated measure model including treatment, Baseline disease severity (SES-CD \< 15 and ≥ 15), week, Baseline, interaction of treatment and week.|mixed-effect model repeated measure|||Week 4||400.56|-1119.52|0.352
72353832|NCT02365649|144227474|SUPERIORITY||LS Mean Difference|-396.2||||0.503|TWO_SIDED|95.0|-1565.39|772.9||P value for test of difference using the repeated measure model including treatment, Baseline disease severity (SES-CD \< 15 and ≥ 15), week, Baseline, interaction of treatment and week.|mixed-effect model repeated measure|||Week 16||772.90|-1565.39|0.503
72353833|NCT02365649|144227474|SUPERIORITY||LS Mean Difference|-364.3||||0.537|TWO_SIDED|95.0|-1531.04|802.44||P value for test of difference using the repeated measure model including treatment, Baseline disease severity (SES-CD \< 15 and ≥ 15), week, Baseline, interaction of treatment and week.|mixed-effect model repeated measure|||Week 16||802.44|-1531.04|0.537
72353834|NCT02365649|144227474|SUPERIORITY||LS Mean Difference|-483.2||||0.425|TWO_SIDED|95.0|-1677.87|711.52||P value for test of difference using the repeated measure model including treatment, Baseline disease severity (SES-CD \< 15 and ≥ 15), week, Baseline, interaction of treatment and week.|mixed-effect model repeated measure|||Week 16||711.52|-1677.87|0.425
72353835|NCT02365649|144227474|SUPERIORITY||LS Mean Difference|-1025.6||||0.134|TWO_SIDED|95.0|-2373.24|322.08||P value for test of difference using the repeated measure model including treatment, Baseline disease severity (SES-CD \< 15 and ≥ 15), week, Baseline, interaction of treatment and week.|mixed-effect model repeated measure|||Week 16||322.08|-2373.24|0.134
72353836|NCT02365649|144227474|SUPERIORITY||LS Mean Difference|-637.9||||0.293|TWO_SIDED|95.0|-1833.82|557.96||P value for test of difference using the repeated measure model including treatment, Baseline disease severity (SES-CD \< 15 and ≥ 15), week, Baseline, interaction of treatment and week.|mixed-effect model repeated measure|||Week 16||557.96|-1833.82|0.293
72353837|NCT02365649|144227475|SUPERIORITY||LS Mean Difference|0.5||||0.921|TWO_SIDED|95.0|-9.02|9.97||P value for test of difference using the repeated measure model including treatment, Baseline disease severity (SES-CD \< 15 and ≥ 15), week, Baseline, interaction of treatment and week.|mixed-effect model repeated measure|||||9.97|-9.02|0.921
72353838|NCT02365649|144227475|SUPERIORITY||LS Mean Difference|-1.6||||0.75|TWO_SIDED|95.0|-11.19|8.08||P value for test of difference using the repeated measure model including treatment, Baseline disease severity (SES-CD \< 15 and ≥ 15), week, Baseline, interaction of treatment and week.|mixed-effect model repeated measure|||||8.08|-11.19|0.75
72353839|NCT02365649|144227475|SUPERIORITY||LS Mean Difference|-1.9||||0.7|TWO_SIDED|95.0|-11.7|7.87||P value for test of difference using the repeated measure model including treatment, Baseline disease severity (SES-CD \< 15 and ≥ 15), week, Baseline, interaction of treatment and week.|mixed-effect model repeated measure|||||7.87|-11.7|0.7
72353840|NCT02365649|144227475|SUPERIORITY||LS Mean Difference|-11.4||||0.024|TWO_SIDED|95.0|-21.38|-1.51||P value for test of difference using the repeated measure model including treatment, Baseline disease severity (SES-CD \< 15 and ≥ 15), week, Baseline, interaction of treatment and week.|mixed-effect model repeated measure|||||-1.51|-21.38|0.024
72353841|NCT02365649|144227475|SUPERIORITY||LS Mean Difference|-1.0||||0.845|TWO_SIDED|95.0|-10.72|8.79||P value for test of difference using the repeated measure model including treatment, Baseline disease severity (SES-CD \< 15 and ≥ 15), week, Baseline, interaction of treatment and week.|mixed-effect model repeated measure|||||8.79|-10.72|0.845
72353842|NCT02365649|144227476|SUPERIORITY||LS Mean Difference|1.7||||0.83|TWO_SIDED|95.0|-13.6|16.92||P value for test of difference using the repeated measure model including treatment, Baseline disease severity (SES-CD \< 15 and ≥ 15), week, Baseline, interaction of treatment and week.|mixed-effect model repeated measure|||Week 8||16.92|-13.60|0.830
72353843|NCT02365649|144227476|SUPERIORITY||LS Mean Difference|17.5||||0.027|TWO_SIDED|95.0|2.03|33.0||P value for test of difference using the repeated measure model including treatment, Baseline disease severity (SES-CD \< 15 and ≥ 15), week, Baseline, interaction of treatment and week.|mixed-effect model repeated measure|||Week 8||33.00|2.03|0.027
72353844|NCT02365649|144227476|SUPERIORITY||LS Mean Difference|8.9||||0.263|TWO_SIDED|95.0|-6.72|24.47||P value for test of difference using the repeated measure model including treatment, Baseline disease severity (SES-CD \< 15 and ≥ 15), week, Baseline, interaction of treatment and week.|mixed-effect model repeated measure|||Week 8||24.47|-6.72|0.263
72353845|NCT02365649|144227476|SUPERIORITY||LS Mean Difference|21.6||||0.008|TWO_SIDED|95.0|5.68|37.52||P value for test of difference using the repeated measure model including treatment, Baseline disease severity (SES-CD \< 15 and ≥ 15), week, Baseline, interaction of treatment and week.|mixed-effect model repeated measure|||Week 8||37.52|5.68|0.008
72353846|NCT02365649|144227476|SUPERIORITY||LS Mean Difference|8.8||||0.269|TWO_SIDED|95.0|-6.88|24.53||P value for test of difference using the repeated measure model including treatment, Baseline disease severity (SES-CD \< 15 and ≥ 15), week, Baseline, interaction of treatment and week.|mixed-effect model repeated measure|||Week 8||24.53|-6.88|0.269
72353847|NCT02365649|144227476|SUPERIORITY||LS Mean Difference|10.3||||0.231|TWO_SIDED|95.0|-6.63|27.25||P value for test of difference using the repeated measure model including treatment, Baseline disease severity (SES-CD \< 15 and ≥ 15), week, Baseline, interaction of treatment and week.|mixed-effect model repeated measure|||Week 16||27.25|-6.63|0.231
72353848|NCT02365649|144227476|SUPERIORITY||LS Mean Difference|27.9||||0.002|TWO_SIDED|95.0|10.68|45.15||P value for test of difference using the repeated measure model including treatment, Baseline disease severity (SES-CD \< 15 and ≥ 15), week, Baseline, interaction of treatment and week.|mixed-effect model repeated measure|||||45.15|10.68|0.002
72353849|NCT02365649|144227476|SUPERIORITY||LS Mean Difference|17.1||||0.057|TWO_SIDED|95.0|-0.51|34.72||P value for test of difference using the repeated measure model including treatment, Baseline disease severity (SES-CD \< 15 and ≥ 15), week, Baseline, interaction of treatment and week.|mixed-effect model repeated measure|||Week 16||34.72|-0.51|0.057
72353850|NCT02365649|144227476|SUPERIORITY||LS Mean Difference|28.8||||0.002|TWO_SIDED|95.0|11.12|46.56||P value for test of difference using the repeated measure model including treatment, Baseline disease severity (SES-CD \< 15 and ≥ 15), week, Baseline, interaction of treatment and week.|mixed-effect model repeated measure|||Week 16||46.56|11.12|0.002
72353851|NCT02365649|144227476|SUPERIORITY||LS Mean Difference|12.3||||0.165|TWO_SIDED|95.0|-5.12|29.72||P value for test of difference using the repeated measure model including treatment, Baseline disease severity (SES-CD \< 15 and ≥ 15), week, Baseline, interaction of treatment and week.|mixed-effect model repeated measure|||||29.72|-5.12|0.165
72353852|NCT02365649|144227477|SUPERIORITY||Adjusted risk difference from placebo|20.0||||0.167|TWO_SIDED|95.0|-8.4|48.4||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||48.4|-8.4|0.167
72353853|NCT02365649|144227477|SUPERIORITY||Adjusted risk difference from placebo|16.7||||0.221|TWO_SIDED|95.0|-10.0|43.3||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||43.3|-10.0|0.221
72353854|NCT02365649|144227477|SUPERIORITY||Adjusted risk difference from placebo|20.0||||0.18|TWO_SIDED|95.0|-9.2|49.2||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||49.2|-9.2|0.18
72353855|NCT02365649|144227477|SUPERIORITY||LS Mean Difference|20.0||||0.167|TWO_SIDED|95.0|-8.4|48.4||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||48.4|-8.4|0.167
72353856|NCT02365649|144227478|SUPERIORITY||Adjusted risk difference from placebo|5.5||||0.607|TWO_SIDED|95.0|-15.5|26.5||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||26.5|-15.5|0.607
72353857|NCT02365649|144227478|SUPERIORITY||Adjusted risk difference from placebo|12.2||||0.272|TWO_SIDED|95.0|-9.6|33.9||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||33.9|-9.6|0.272
72353858|NCT02365649|144227478|SUPERIORITY||Adjusted risk difference from placebo|15.9||||-0.157|TWO_SIDED|95.0|-6.1|37.9||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||37.9|-6.1|-0.157
72353859|NCT02365649|144227478|SUPERIORITY||LS Mean Difference|27.7||||0.017|TWO_SIDED|95.0|4.9|50.6||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||50.6|4.9|0.017
72353860|NCT02365649|144227478|SUPERIORITY||Adjusted risk difference from placebo|2.8||||0.798|TWO_SIDED|95.0|-18.4|23.9||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||23.9|-18.4|0.798
72353861|NCT02365649|144227479|SUPERIORITY||Adjusted risk difference from placebo|9.8||||0.119|TWO_SIDED|95.0|-2.5|22.1||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||22.1|-2.5|0.119
72353862|NCT02365649|144227479|SUPERIORITY||Adjusted risk difference from placebo|15.4||||0.034|TWO_SIDED|95.0|1.1|29.7||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||29.7|1.1|0.034
72353863|NCT02365649|144227479|SUPERIORITY||Adjusted risk difference from placebo|23.2||||0.004|TWO_SIDED|95.0|7.3|39.2||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||39.2|7.3|0.004
72353864|NCT02365649|144227479|SUPERIORITY||Adjusted risk difference from placebo|32.4|||<|0.001|TWO_SIDED|95.0|14.2|50.5||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||50.5|14.2|< 0.001
72353865|NCT02365649|144227479|SUPERIORITY||Adjusted risk difference from placebo|22.9|||<|0.006|TWO_SIDED|95.0|6.6|39.2||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||39.2|6.6|< 0.006
72353866|NCT02365649|144227480|SUPERIORITY||Adjusted risk difference from placebo|3.9||||0.647|TWO_SIDED|95.0|-12.7|20.5||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||20.5|-12.7|0.647
72353867|NCT02365649|144227480|SUPERIORITY||Adjusted risk difference from placebo|17.1||||0.093|TWO_SIDED|95.0|-2.9|37.1||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||37.1|-2.9|0.093
72353868|NCT02365649|144227480|SUPERIORITY||Adjusted risk difference from placebo|13.6||||0.165|TWO_SIDED|95.0|-5.6|32.8||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||32.8|-5.6|0.165
72353869|NCT02365649|144227480|SUPERIORITY||Adjusted risk difference from placebo|24.9||||0.023|TWO_SIDED|95.0|3.4|46.3||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||46.3|3.4|0.023
72353870|NCT02365649|144227480|SUPERIORITY||Adjusted risk difference from placebo|7.0||||0.448|TWO_SIDED|95.0|-11.0|25.0||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||25.0|-11.0|0.448
72353871|NCT02365649|144227481|SUPERIORITY||LS Mean Difference|0.4||||0.412|TWO_SIDED|95.0|-0.62|1.5||P value for test of difference using the repeated measure model including treatment, Baseline disease severity (SES-CD \< 15 and ≥ 15), week, Baseline, interaction of treatment and week.|mixed-effect model repeated measure|||||1.5|-0.62|0.412
72353872|NCT02365649|144227481|SUPERIORITY||LS Mean Difference|-1.4||||0.01|TWO_SIDED|95.0|-2.47|-0.34||P value for test of difference using the repeated measure model including treatment, Baseline disease severity (SES-CD \< 15 and ≥ 15), week, Baseline, interaction of treatment and week.|mixed-effect model repeated measure|||||-0.34|-2.47|0.01
72353873|NCT02365649|144227481|SUPERIORITY||LS Mean Difference|-1.0||||0.082|TWO_SIDED|95.0|-2.13|0.13||P value for test of difference using the repeated measure model including treatment, Baseline disease severity (SES-CD \< 15 and ≥ 15), week, Baseline, interaction of treatment and week.|mixed-effect model repeated measure|||||0.13|-2.13|0.082
72353874|NCT02365649|144227481|SUPERIORITY||LS Mean Difference|-1.6||||0.004|TWO_SIDED|95.0|-2.73|-0.52||P value for test of difference using the repeated measure model including treatment, Baseline disease severity (SES-CD \< 15 and ≥ 15), week, Baseline, interaction of treatment and week.|mixed-effect model repeated measure|||||-0.52|-2.73|0.004
72353875|NCT02365649|144227481|SUPERIORITY||LS Mean Difference|0.2||||0.766|TWO_SIDED|95.0|-0.93|1.26||P value for test of difference using the repeated measure model including treatment, Baseline disease severity (SES-CD \< 15 and ≥ 15), week, Baseline, interaction of treatment and week.|mixed-effect model repeated measure|||||1.26|-0.93|0.766
72353876|NCT02365649|144227482|SUPERIORITY||LS Mean Difference|-0.6||||0.314|TWO_SIDED|95.0|-1.75|0.56||P value for test of difference using the repeated measure model including treatment, Baseline disease severity (SES-CD \< 15 and ≥ 15), week, Baseline, interaction of treatment and week.|mixed-effect model repeated measure|||||0.56|-1.75|0.314
72353877|NCT02365649|144227482|SUPERIORITY||LS Mean Difference|-1.8||||0.002|TWO_SIDED|95.0|-3.01|-0.68||P value for test of difference using the repeated measure model including treatment, Baseline disease severity (SES-CD \< 15 and ≥ 15), week, Baseline, interaction of treatment and week.|mixed-effect model repeated measure|||||-0.68|-3.01|0.002
72353878|NCT02365649|144227482|SUPERIORITY||LS Mean Difference|-0.7||||0.255|TWO_SIDED|95.0|-1.94|0.52||P value for test of difference using the repeated measure model including treatment, Baseline disease severity (SES-CD \< 15 and ≥ 15), week, Baseline, interaction of treatment and week.|mixed-effect model repeated measure|||||0.52|-1.94|0.255
72353879|NCT02365649|144227482|SUPERIORITY||LS Mean Difference|-1.4||||0.022|TWO_SIDED|95.0|-2.61|-0.2||P value for test of difference using the repeated measure model including treatment, Baseline disease severity (SES-CD \< 15 and ≥ 15), week, Baseline, interaction of treatment and week.|mixed-effect model repeated measure|||||-0.2|-2.61|0.022
72353880|NCT02365649|144227482|SUPERIORITY||LS Mean Difference|-0.7||||0.239|TWO_SIDED|95.0|-1.92|0.48||P value for test of difference using the repeated measure model including treatment, Baseline disease severity (SES-CD \< 15 and ≥ 15), week, Baseline, interaction of treatment and week.|mixed-effect model repeated measure|||||0.48|-1.92|0.239
72353881|NCT02365649|144227483|SUPERIORITY||Risk Difference (RD)|-7.5||||1|TWO_SIDED|95.0|-36.4|21.4||P value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Responders||21.4|-36.4|1.000
72353882|NCT02365649|144227483|SUPERIORITY||Risk Difference (RD)|5.0||||1|TWO_SIDED|95.0|-22.5|32.5||P value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Responders||32.5|-22.5|1.000
72353883|NCT02365649|144227483|SUPERIORITY||Risk Difference (RD)|-20.0||||0.272|TWO_SIDED|95.0|-37.5|-2.5||P value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Responders||-2.5|-37.5|0.272
72353884|NCT02365649|144227483|SUPERIORITY||Risk Difference (RD)|2.9||||1|TWO_SIDED|95.0|-2.7|8.6||P value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Non-responders||8.6|-2.7|1.000
72353885|NCT02365649|144227483|SUPERIORITY||Risk Difference (RD)|13.0||||0.068|TWO_SIDED|95.0|-0.7|26.8||P value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Non-responders||26.8|-0.7|0.068
72353886|NCT02365649|144227483|SUPERIORITY||Risk Difference (RD)|-5.4||||1|TWO_SIDED|95.0|-23.1|12.3||P value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical responders||12.3|-23.1|1.0000
72353887|NCT02365649|144227483|SUPERIORITY||Risk Difference (RD)|1.3||||1|TWO_SIDED|95.0|-15.7|18.3||P value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical responders||18.3|-15.7|1.000
72353888|NCT02365649|144227483|SUPERIORITY||Risk Difference (RD)|3.3||||1|TWO_SIDED|95.0|-16.7|23.3||P value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical responders||23.3|-16.7|1.000
72353889|NCT02365649|144227483|SUPERIORITY||Risk Difference (RD)|4.8||||1|TWO_SIDED|95.0|-4.3|13.9||P value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical non-responders||13.9|-4.3|1.000
72353890|NCT02365649|144227484|SUPERIORITY||Risk Difference (RD)|0.0||||1|TWO_SIDED|95.0|-35.5|35.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders||35.5|-35.5|1.000
72353891|NCT02365649|144227484|SUPERIORITY||Risk Difference (RD)|12.5||||0.483|TWO_SIDED|95.0|-17.9|42.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders||42.9|-17.9|0.483
72353892|NCT02365649|144227484|SUPERIORITY||Risk Difference (RD)|-15.0||||0.633|TWO_SIDED|95.0|-41.6|11.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders||11.6|-41.6|0.633
72353893|NCT02365649|144227484|SUPERIORITY||Risk Difference (RD)|6.9||||0.424|TWO_SIDED|95.0|-12.7|26.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders||26.4|-12.7|0.424
72353894|NCT02365649|144227484|SUPERIORITY||Risk Difference (RD)|5.7||||0.614|TWO_SIDED|95.0|-5.6|17.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders||17.0|-5.6|0.614
72353895|NCT02365649|144227484|SUPERIORITY||Risk Difference (RD)|14.3||||0.149|TWO_SIDED|95.0|-2.4|30.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders||30.9|-2.4|0.149
72353896|NCT02365649|144227484|SUPERIORITY||Risk Difference (RD)|5.8||||0.684|TWO_SIDED|95.0|-19.1|30.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders||30.7|-19.1|0.684
72353897|NCT02365649|144227484|SUPERIORITY||Risk Difference (RD)|8.5||||0.404|TWO_SIDED|95.0|-11.5|28.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders||28.5|-11.5|0.404
72353898|NCT02365649|144227484|SUPERIORITY||Risk Difference (RD)|10.7||||0.47|TWO_SIDED|95.0|-12.8|34.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders||34.1|-12.8|0.470
72353899|NCT02365649|144227484|SUPERIORITY||Risk Difference (RD)|-5.0||||1|TWO_SIDED|95.0|-14.6|4.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders||4.6|-14.6|1.000
72353900|NCT02365649|144227484|SUPERIORITY||Risk Difference (RD)|4.5||||1|TWO_SIDED|95.0|-11.3|20.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders||20.3|-11.3|1.000
72353901|NCT02365649|144227484|SUPERIORITY||Risk Difference (RD)|-5.0||||1|TWO_SIDED|95.0|-14.6|4.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders||4.6|-14.6|1.000
72353902|NCT02365649|144227485|SUPERIORITY||Risk Difference (RD)|-16.9||||0.624|TWO_SIDED|95.0|-48.4|14.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders||14.6|-48.4|0.624
72353903|NCT02365649|144227485|SUPERIORITY||Risk Difference (RD)|3.9||||1|TWO_SIDED|95.0|-28.3|36.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders||36.1|-28.3|1.000
72353904|NCT02365649|144227485|SUPERIORITY||Risk Difference (RD)|-19.4||||0.363|TWO_SIDED|95.0|-48.0|9.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders||9.1|-48.0|0.363
72353905|NCT02365649|144227485|SUPERIORITY||Risk Difference (RD)|6.1||||0.495|TWO_SIDED|95.0|-2.1|14.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders||14.2|-2.1|0.495
72353906|NCT02365649|144227485|SUPERIORITY||Risk Difference (RD)|15.0||||0.066|TWO_SIDED|95.0|-0.6|30.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5). Prespecified significance at the 0.1 level.|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders||30.6|-0.6|0.066
72353907|NCT02365649|144227485|SUPERIORITY||Risk Difference (RD)|-10.7||||0.645|TWO_SIDED|95.0|-30.3|8.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders||8.9|-30.3|0.645
72353908|NCT02365649|144227485|SUPERIORITY||Risk Difference (RD)|4.4||||0.686|TWO_SIDED|95.0|-16.8|25.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders||25.5|-16.8|0.686
72353909|NCT02365649|144227485|SUPERIORITY||Risk Difference (RD)|4.4||||0.721|TWO_SIDED|95.0|-19.5|28.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders||28.2|-19.5|0.721
72353910|NCT02365649|144227485|SUPERIORITY||Risk Difference (RD)|4.8||||1|TWO_SIDED|95.0|-4.3|13.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders||13.9|-4.3|1.000
72353911|NCT02365649|144227486|SUPERIORITY||Risk Difference (RD)|-7.5||||1|TWO_SIDED|95.0|-47.5|32.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 20||32.5|-47.5|1.000
72353912|NCT02365649|144227486|SUPERIORITY||Risk Difference (RD)|5.0||||0.765|TWO_SIDED|95.0|-27.8|37.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 20||37.8|-27.8|0.765
72353913|NCT02365649|144227486|SUPERIORITY||Risk Difference (RD)|-5.0||||1|TWO_SIDED|95.0|-42.4|32.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 20||32.4|-42.4|1.000
72353914|NCT02365649|144227486|SUPERIORITY||Risk Difference (RD)|-7.5||||1|TWO_SIDED|95.0|-47.5|32.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 28||32.5|-47.5|1.000
72353915|NCT02365649|144227486|SUPERIORITY||Risk Difference (RD)|11.3||||0.502|TWO_SIDED|95.0|-21.4|43.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 28||43.9|-21.4|0.502
72353916|NCT02365649|144227486|SUPERIORITY||Risk Difference (RD)|5.0||||1|TWO_SIDED|95.0|-32.9|42.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 28||42.9|-32.9|1.000
72353917|NCT02365649|144227486|SUPERIORITY||Risk Difference (RD)|-2.5||||1|TWO_SIDED|95.0|-42.3|37.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 36||37.3|-42.3|1.000
72353918|NCT02365649|144227486|SUPERIORITY||Risk Difference (RD)|22.5||||0.18|TWO_SIDED|95.0|-9.5|54.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 36||54.5|-9.5|0.180
72353919|NCT02365649|144227486|SUPERIORITY||Risk Difference (RD)|-10.0||||0.702|TWO_SIDED|95.0|-45.6|25.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 36||25.6|-45.6|0.702
72353920|NCT02365649|144227486|SUPERIORITY||Risk Difference (RD)|-27.5||||0.214|TWO_SIDED|95.0|-58.9|3.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 44||3.9|-58.9|0.214
72353921|NCT02365649|144227486|SUPERIORITY||Risk Difference (RD)|28.8||||0.086|TWO_SIDED|95.0|-2.5|60.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5). Prespecified statistical significance at the 0.1 level.|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 44||60.0|-2.5|0.086
72353922|NCT02365649|144227486|SUPERIORITY||Risk Difference (RD)|0.0||||1|TWO_SIDED|95.0|-37.2|37.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 44||37.2|-37.2|1.000
72353923|NCT02365649|144227486|SUPERIORITY||Risk Difference (RD)|7.5||||1|TWO_SIDED|95.0|-31.6|46.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 52||46.6|-31.6|1.000
72353924|NCT02365649|144227486|SUPERIORITY||Risk Difference (RD)|32.5||||0.051|TWO_SIDED|95.0|1.4|63.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5). Prespecified statistical significance at the 0.1 level.|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 52||63.6|1.4|0.051
72353925|NCT02365649|144227486|SUPERIORITY||Risk Difference (RD)|0.0||||1|TWO_SIDED|95.0|-34.8|34.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 52||34.8|-34.8|1.000
72353926|NCT02365649|144227486|SUPERIORITY||Risk Difference (RD)|27.5||||0.075|TWO_SIDED|95.0|-5.0|60.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5). Prespecified statistical significance at the 0.1 level.|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 20||60.0|-5.0|0.075
72353927|NCT02365649|144227486|SUPERIORITY||Risk Difference (RD)|-3.7||||0.705|TWO_SIDED|95.0|-18.6|11.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 20||11.2|-18.6|0.705
72353928|NCT02365649|144227486|SUPERIORITY||Risk Difference (RD)|-3.8||||1|TWO_SIDED|95.0|-20.0|12.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 20||12.4|-20.0|1.000
72353929|NCT02365649|144227486|SUPERIORITY||Risk Difference (RD)|27.5||||0.075|TWO_SIDED|95.0|-5.0|60.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5). Prespecified statistical significance at the 0.1 level.|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 28||60.0|-5.0|0.075
72353930|NCT02365649|144227486|SUPERIORITY||Risk Difference (RD)|-3.7||||0.705|TWO_SIDED|95.0|-18.6|11.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 28||11.2|-18.6|0.705
72353931|NCT02365649|144227486|SUPERIORITY||Risk Difference (RD)|0.5||||1|TWO_SIDED|95.0|-17.4|18.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 28||18.5|-17.4|1.000
72353932|NCT02365649|144227486|SUPERIORITY||Risk Difference (RD)|0.6||||1|TWO_SIDED|95.0|-20.5|21.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 36||21.8|-20.5|1.000
72353933|NCT02365649|144227486|SUPERIORITY||Risk Difference (RD)|-6.4||||0.348|TWO_SIDED|95.0|-18.0|5.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 36||5.2|-18.0|0.348
72353934|NCT02365649|144227486|SUPERIORITY||Risk Difference (RD)|3.7||||0.686|TWO_SIDED|95.0|-13.4|20.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 36||20.7|-13.4|0.686
72353935|NCT02365649|144227486|SUPERIORITY||Risk Difference (RD)|7.5||||0.616|TWO_SIDED|95.0|-19.8|34.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 44||34.8|-19.8|0.616
72353936|NCT02365649|144227486|SUPERIORITY||Risk Difference (RD)|-6.6||||0.42|TWO_SIDED|95.0|-20.5|7.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 44||7.3|-20.5|0.420
72353937|NCT02365649|144227486|SUPERIORITY||Risk Difference (RD)|-3.8||||1|TWO_SIDED|95.0|-20.0|12.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 44||12.4|-20.0|1.000
72353938|NCT02365649|144227486|SUPERIORITY||Risk Difference (RD)|0.6||||1|TWO_SIDED|95.0|-20.5|21.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 52||21.8|-20.5|1.000
72353939|NCT02365649|144227486|SUPERIORITY||Risk Difference (RD)|-0.6||||1|TWO_SIDED|95.0|-14.4|13.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 52||13.3|-14.4|1.000
72429208|NCT01058863|144369415|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|27.73|STANDARD_ERROR_OF_MEAN|3.686|<|0.001|TWO_SIDED|95.0|20.47|34.99||Significance at the 0.05 level.|ANOVA|Fixed effects of baseline PPFEV1 as a covariate, sequence, treatment group, period, and center, and random effect for subject within sequence.||Of interest was the mean difference between each active group and placebo at each dose level. Analyses were performed at the 2-sided 0.05 significance level in this sequence: Albuterol Spiromax 180 mcg versus placebo; Albuterol Spiromax 90 mcg versus placebo, ProAir HFA 180 mcg versus placebo, and ProAir HFA 90 mcg versus placebo. If a test was not significant, no further tests were done. This sequential procedure preserved the error rate for the family of tests at the 0.05 level.||34.99|20.47|<0.001
72353940|NCT02365649|144227486|SUPERIORITY||Risk Difference (RD)|3.7||||0.686|TWO_SIDED|95.0|-13.4|20.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 52||20.7|-13.4|0.686
72353941|NCT02365649|144227486|SUPERIORITY||Risk Difference (RD)|9.4||||0.555|TWO_SIDED|95.0|-21.9|40.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 20||40.6|-21.9|0.555
72353942|NCT02365649|144227486|SUPERIORITY||Risk Difference (RD)|-2.7||||0.83|TWO_SIDED|95.0|-27.2|21.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 20||21.8|-27.2|0.830
72353943|NCT02365649|144227486|SUPERIORITY||Risk Difference (RD)|-9.0||||0.518|TWO_SIDED|95.0|-36.0|17.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 20||17.9|-36.0|0.518
72353944|NCT02365649|144227486|SUPERIORITY||Risk Difference (RD)|12.5||||0.428|TWO_SIDED|95.0|-18.6|43.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 28||43.6|-18.6|0.428
72353945|NCT02365649|144227486|SUPERIORITY||Risk Difference (RD)|3.9||||0.757|TWO_SIDED|95.0|-20.7|28.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 28||28.4|-20.7|0.757
72353946|NCT02365649|144227486|SUPERIORITY||Risk Difference (RD)|4.6||||0.745|TWO_SIDED|95.0|-23.2|32.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 28||32.4|-23.2|0.745
72353947|NCT02365649|144227486|SUPERIORITY||Risk Difference (RD)|-5.8||||1|TWO_SIDED|95.0|-34.6|23.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 36||23.0|-34.6|1.000
72353948|NCT02365649|144227486|SUPERIORITY||Risk Difference (RD)|3.6||||0.773|TWO_SIDED|95.0|-20.6|27.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 36||27.7|-20.6|0.773
72353949|NCT02365649|144227486|SUPERIORITY||Risk Difference (RD)|-2.8||||0.838|TWO_SIDED|95.0|-29.4|23.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 36||23.8|-29.4|0.838
72353950|NCT02365649|144227486|SUPERIORITY||Risk Difference (RD)|-12.9||||0.497|TWO_SIDED|95.0|-40.0|14.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 44||14.1|-40.0|0.497
72353951|NCT02365649|144227486|SUPERIORITY||Risk Difference (RD)|10.5||||0.404|TWO_SIDED|95.0|-14.0|34.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 44||34.9|-14.0|0.404
72353952|NCT02365649|144227486|SUPERIORITY||Risk Difference (RD)|-2.8||||0.838|TWO_SIDED|95.0|-29.4|23.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 44||23.8|-29.4|0.838
72353953|NCT02365649|144227486|SUPERIORITY||Risk Difference (RD)|3.6||||1|TWO_SIDED|95.0|-24.4|31.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 52||31.6|-24.4|1.000
72353954|NCT02365649|144227486|SUPERIORITY||Risk Difference (RD)|16.4||||0.174|TWO_SIDED|95.0|-7.0|39.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 52||39.8|-7.0|0.174
72353955|NCT02365649|144227486|SUPERIORITY||Risk Difference (RD)|6.6||||0.611|TWO_SIDED|95.0|-19.1|32.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 52||32.3|-19.1|0.611
72353956|NCT02365649|144227486|SUPERIORITY||Risk Difference (RD)|-5.0||||1|TWO_SIDED|95.0|-14.6|4.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 28||4.6|-14.6|1.000
72353957|NCT02365649|144227486|SUPERIORITY||Risk Difference (RD)|-5.0||||0.488|TWO_SIDED|95.0|-14.6|4.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 28||4.6|-14.6|0.488
72353958|NCT02365649|144227486|SUPERIORITY||Risk Difference (RD)|-5.0||||1|TWO_SIDED|95.0|-14.6|4.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 28||4.6|-14.6|1.000
72353959|NCT02365649|144227486|SUPERIORITY||Risk Difference (RD)|-5.0||||1|TWO_SIDED|95.0|-14.6|4.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 44||4.6|-14.6|1.000
72353960|NCT02365649|144227486|SUPERIORITY||Risk Difference (RD)|-5.0||||0.488|TWO_SIDED|95.0|-14.6|4.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 44||4.6|-14.6|0.488
72353961|NCT02365649|144227486|SUPERIORITY||Risk Difference (RD)|-5.0||||1|TWO_SIDED|95.0|-14.6|4.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 44||4.6|-14.6|1.000
72353962|NCT02365649|144227486|SUPERIORITY||Risk Difference (RD)|-5.0||||1|TWO_SIDED|95.0|-14.6|4.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 52||4.6|-14.6|1.000
72353963|NCT02365649|144227486|SUPERIORITY||Risk Difference (RD)|-0.2||||1|TWO_SIDED|95.0|-13.4|13.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 52||13.0|-13.4|1.000
72353964|NCT02365649|144227486|SUPERIORITY||Risk Difference (RD)|-5.0||||1|TWO_SIDED|95.0|-14.6|4.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 52||4.6|-14.6|1.000
72353965|NCT02365649|144227487|SUPERIORITY||Risk Difference (RD)|-13.3||||1|TWO_SIDED|95.0|-72.2|45.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 20||45.5|-72.2|1.000
72353966|NCT02365649|144227487|SUPERIORITY||Risk Difference (RD)|-8.6||||1|TWO_SIDED|95.0|-50.2|33.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 20||33.1|-50.2|1.000
72353967|NCT02365649|144227487|SUPERIORITY||Risk Difference (RD)|20.0||||1|TWO_SIDED|95.0|-4.8|44.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 20||44.8|-4.8|1.000
72353968|NCT02365649|144227487|SUPERIORITY||Risk Difference (RD)|-23.3||||0.423|TWO_SIDED|95.0|-79.8|33.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 28||33.2|-79.8|0.423
72353969|NCT02365649|144227487|SUPERIORITY||Risk Difference (RD)|-32.9||||0.25|TWO_SIDED|95.0|-74.0|8.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 28||8.2|-74.0|0.250
72353970|NCT02365649|144227487|SUPERIORITY||Risk Difference (RD)|10.0||||1|TWO_SIDED|95.0|-8.6|28.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 28||28.6|-8.6|1.000
72353971|NCT02365649|144227487|SUPERIORITY||Risk Difference (RD)|20.0||||1|TWO_SIDED|95.0|-4.8|44.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 36||44.8|-4.8|1.000
72353972|NCT02365649|144227487|SUPERIORITY||Risk Difference (RD)|-8.6||||1|TWO_SIDED|95.0|-50.2|33.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 36||33.1|-50.2|1.000
72353973|NCT02365649|144227487|SUPERIORITY||Risk Difference (RD)|-13.3||||1|TWO_SIDED|95.0|-72.2|45.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 36||45.5|-72.2|1.000
72353974|NCT02365649|144227487|SUPERIORITY||Risk Difference (RD)|-46.7||||0.203|TWO_SIDED|95.0|-100.0|12.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 44||12.2|-100.0|0.203
72353975|NCT02365649|144227487|SUPERIORITY||Risk Difference (RD)|-8.6||||1|TWO_SIDED|95.0|-50.2|33.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 44||33.1|-50.2|1.000
72353976|NCT02365649|144227487|SUPERIORITY||Risk Difference (RD)|-13.3||||1|TWO_SIDED|95.0|-72.2|45.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 44||45.5|-72.2|1.000
72353977|NCT02365649|144227487|SUPERIORITY||Risk Difference (RD)|6.7||||1|TWO_SIDED|95.0|-54.7|68.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 52||68.0|-54.7|1.000
72353978|NCT02365649|144227487|SUPERIORITY||Risk Difference (RD)|11.4||||1|TWO_SIDED|95.0|-33.8|56.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 52||56.6|-33.8|1.000
72353979|NCT02365649|144227487|SUPERIORITY||Risk Difference (RD)|6.7||||1|TWO_SIDED|95.0|-54.7|68.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 52||68.0|-54.7|1.000
72353980|NCT02365649|144227487|SUPERIORITY||Risk Difference (RD)|33.3||||1|TWO_SIDED|95.0|-20.0|86.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 20||86.7|-20.0|1.000
72353981|NCT02365649|144227487|SUPERIORITY||Risk Difference (RD)|-16.7||||1|TWO_SIDED|95.0|-100.0|70.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 20||70.8|-100.0|1.000
72353982|NCT02365649|144227487|SUPERIORITY||Risk Difference (RD)|33.3||||1|TWO_SIDED|95.0|-20.0|86.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 20||86.7|-20.0|1.000
72353983|NCT02365649|144227487|SUPERIORITY||Risk Difference (RD)|33.3||||1|TWO_SIDED|95.0|-20.0|86.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 28||86.7|-20.0|1.000
72353984|NCT02365649|144227487|SUPERIORITY||Risk Difference (RD)|-16.7||||1|TWO_SIDED|95.0|-100.0|70.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 28||70.8|-100.0|1.000
72353985|NCT02365649|144227487|SUPERIORITY||Risk Difference (RD)|33.3||||1|TWO_SIDED|95.0|-20.0|86.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 28||86.7|-20.0|1.000
72353986|NCT02365649|144227487|SUPERIORITY||Risk Difference (RD)|-33.3||||1|TWO_SIDED|95.0|-100.0|42.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 36||42.1|-100.0|1.000
72353987|NCT02365649|144227487|SUPERIORITY||Risk Difference (RD)|-16.7||||1|TWO_SIDED|95.0|-100.0|70.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 36||70.8|-100.0|1.000
72353988|NCT02365649|144227487|SUPERIORITY||Risk Difference (RD)|33.3||||1|TWO_SIDED|95.0|-20.0|86.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 36||86.7|-20.0|1.000
72353989|NCT02365649|144227487|SUPERIORITY||Risk Difference (RD)|0.0||||1|TWO_SIDED|95.0|-75.4|75.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 44||75.4|-75.4|1.000
72353990|NCT02365649|144227487|SUPERIORITY||Risk Difference (RD)|-16.7||||1|TWO_SIDED|95.0|-100.0|70.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 44||70.8|-100.0|1.000
72353991|NCT02365649|144227487|SUPERIORITY||Risk Difference (RD)|33.3||||1|TWO_SIDED|95.0|-20.0|86.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 44||86.7|-20.0|1.000
72353992|NCT02365649|144227487|SUPERIORITY||Risk Difference (RD)|0.0||||1|TWO_SIDED|95.0|-75.4|75.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 52||75.4|-75.4|1.000
72353993|NCT02365649|144227487|SUPERIORITY||Risk Difference (RD)|-33.3||||1|TWO_SIDED|95.0|-86.7|20.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 52||20.0|-86.7|1.000
72353994|NCT02365649|144227487|SUPERIORITY||Risk Difference (RD)|66.7||||1|TWO_SIDED|95.0|13.3|100.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 52||100.0|13.3|1.000
72353995|NCT02365649|144227487|SUPERIORITY||Risk Difference (RD)|6.4||||1|TWO_SIDED|90.0|-31.2|44.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 20||44.0|-31.2|1.000
72353996|NCT02365649|144227487|SUPERIORITY||Risk Difference (RD)|-10.3||||0.655|TWO_SIDED|95.0|-48.6|28.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 20||28.1|-48.6|0.655
72353997|NCT02365649|144227487|SUPERIORITY||Risk Difference (RD)|23.1||||0.541|TWO_SIDED|95.0|0.2|46.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 20||46.0|0.2|0.541
72353998|NCT02365649|144227487|SUPERIORITY||Risk Difference (RD)|-1.3||||1|TWO_SIDED|95.0|-37.0|34.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 28||34.4|-37.0|1.000
72353999|NCT02365649|144227487|SUPERIORITY||Risk Difference (RD)|-29.1||||0.178|TWO_SIDED|95.0|-67.0|8.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 28||8.9|-67.0|0.178
72354000|NCT02365649|144227487|SUPERIORITY||Risk Difference (RD)|15.4||||1|TWO_SIDED|95.0|-4.2|35.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 28||35.0|-4.2|1.000
72354001|NCT02365649|144227487|SUPERIORITY||Risk Difference (RD)|-10.3||||1|TWO_SIDED|95.0|-54.4|33.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 36||33.9|-54.4|1.000
72354002|NCT02365649|144227487|SUPERIORITY||Risk Difference (RD)|-10.3||||0.655|TWO_SIDED|95.0|-48.6|28.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 36||28.1|-48.6|0.655
72354003|NCT02365649|144227487|SUPERIORITY||Risk Difference (RD)|-1.9||||1|TWO_SIDED|95.0|-50.1|46.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 36||46.3|-50.1|1.000
72354004|NCT02365649|144227487|SUPERIORITY||Risk Difference (RD)|-26.9||||0.32|TWO_SIDED|95.0|-73.0|19.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 44||19.2|-73.0|0.320
72354005|NCT02365649|144227487|SUPERIORITY||Risk Difference (RD)|-10.3||||0.655|TWO_SIDED|95.0|-48.6|28.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 44||28.1|-48.6|0.655
72354006|NCT02365649|144227487|SUPERIORITY||Risk Difference (RD)|-1.9||||1|TWO_SIDED|95.0|-50.1|46.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 44||46.3|-50.1|1.000
72354007|NCT02365649|144227487|SUPERIORITY||Risk Difference (RD)|-3.8||||1|TWO_SIDED|95.0|-52.2|44.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 52||44.5|-52.2|1.000
72354008|NCT02365649|144227487|SUPERIORITY||Risk Difference (RD)|1.7||||1|TWO_SIDED|95.0|-40.6|44.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 52||44.0|-40.6|1.000
72354009|NCT02365649|144227487|SUPERIORITY||Risk Difference (RD)|21.2||||0.603|TWO_SIDED|95.0|-29.2|71.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 52||71.5|-29.2|0.603
72354010|NCT02365649|144227488|SUPERIORITY||Risk Difference (RD)|15.4||||0.673|TWO_SIDED|95.0|-25.6|56.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 20||56.5|-25.6|0.673
72354011|NCT02365649|144227488|SUPERIORITY||Risk Difference (RD)|19.6||||0.265|TWO_SIDED|95.0|-14.0|53.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 20||53.3|-14.0|0.265
72354012|NCT02365649|144227488|SUPERIORITY||Risk Difference (RD)|12.9||||0.695|TWO_SIDED|95.0|-25.6|51.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 20||51.5|-25.6|0.695
72354013|NCT02365649|144227488|SUPERIORITY||Risk Difference (RD)|-20.6||||0.394|TWO_SIDED|95.0|-61.4|20.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 28||20.3|-61.4|0.394
72354014|NCT02365649|144227488|SUPERIORITY||Risk Difference (RD)|-3.9||||1|TWO_SIDED|95.0|-36.1|28.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 28||28.3|-36.1|1.000
72354015|NCT02365649|144227488|SUPERIORITY||Risk Difference (RD)|-10.6||||0.683|TWO_SIDED|95.0|-47.9|26.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 28||26.7|-47.9|0.683
72354016|NCT02365649|144227488|SUPERIORITY||Risk Difference (RD)|28.7||||0.205|TWO_SIDED|95.0|-4.1|61.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 36||61.4|-4.1|0.205
72354017|NCT02365649|144227488|SUPERIORITY||Risk Difference (RD)|14.5||||0.388|TWO_SIDED|95.0|-17.9|46.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 36||46.9|-17.9|0.388
72354018|NCT02365649|144227488|SUPERIORITY||Risk Difference (RD)|-28.8||||0.236|TWO_SIDED|95.0|-65.6|8.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 36||8.0|-65.6|0.236
72354019|NCT02365649|144227488|SUPERIORITY||Risk Difference (RD)|-9.6||||1|TWO_SIDED|95.0|-50.6|31.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 44||31.5|-50.6|1.000
72354020|NCT02365649|144227488|SUPERIORITY||Risk Difference (RD)|26.3||||0.131|TWO_SIDED|95.0|-6.3|58.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 44||58.9|-6.3|0.131
72354021|NCT02365649|144227488|SUPERIORITY||Risk Difference (RD)|-7.1||||1|TWO_SIDED|95.0|-45.6|31.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 44||31.5|-45.6|1.000
72354022|NCT02365649|144227488|SUPERIORITY||Risk Difference (RD)|21.3||||0.411|TWO_SIDED|95.0|-19.6|62.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 52||62.2|-19.6|0.411
72354023|NCT02365649|144227488|SUPERIORITY||Risk Difference (RD)|32.2||||0.067|TWO_SIDED|95.0|-0.2|64.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5). Prespecified statistical significance at the 0.1 level.|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 52||64.5|-0.2|0.067
72354024|NCT02365649|144227488|SUPERIORITY||Risk Difference (RD)|-1.2||||1|TWO_SIDED|95.0|-39.5|37.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 52||37.2|-39.5|1.000
72354025|NCT02365649|144227488|SUPERIORITY||Risk Difference (RD)|26.6||||0.178|TWO_SIDED|95.0|-8.8|62.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 20||62.0|-8.8|0.178
72354026|NCT02365649|144227488|SUPERIORITY||Risk Difference (RD)|-5.7||||0.72|TWO_SIDED|95.0|-23.8|12.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 20||12.3|-23.8|0.720
72354027|NCT02365649|144227488|SUPERIORITY||Risk Difference (RD)|-7.9||||0.683|TWO_SIDED|95.0|-27.2|11.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 20||11.5|-27.2|0.683
72354028|NCT02365649|144227488|SUPERIORITY||Risk Difference (RD)|23.0||||0.215|TWO_SIDED|95.0|-12.8|58.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 28||58.9|-12.8|0.215
72354029|NCT02365649|144227488|SUPERIORITY||Risk Difference (RD)|-12.3||||0.279|TWO_SIDED|95.0|-30.4|5.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 28||5.8|-30.4|0.279
72354030|NCT02365649|144227488|SUPERIORITY||Risk Difference (RD)|-6.4||||0.716|TWO_SIDED|95.0|-28.2|15.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 28||15.4|-28.2|0.716
72354031|NCT02365649|144227488|SUPERIORITY||Risk Difference (RD)|-3.2||||1|TWO_SIDED|95.0|-27.5|21.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 36||21.1|-27.5|1.000
72354032|NCT02365649|144227488|SUPERIORITY||Risk Difference (RD)|-8.2||||0.4|TWO_SIDED|95.0|-23.5|7.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 36||7.1|-23.5|0.400
72354033|NCT02365649|144227488|SUPERIORITY||Risk Difference (RD)|0.7||||1|TWO_SIDED|95.0|-19.6|21.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 36||21.0|-19.6|1.000
72354034|NCT02365649|144227488|SUPERIORITY||Risk Difference (RD)|7.9||||0.62|TWO_SIDED|95.0|-22.2|38.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 44||38.0|-22.2|0.620
72354035|NCT02365649|144227488|SUPERIORITY||Risk Difference (RD)|-8.2||||0.4|TWO_SIDED|95.0|-23.5|7.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 44||7.1|-23.5|0.400
72354036|NCT02365649|144227488|SUPERIORITY||Risk Difference (RD)|-4.3||||1|TWO_SIDED|95.0|-22.7|14.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 44||14.2|-22.7|1.000
72354037|NCT02365649|144227488|SUPERIORITY||Risk Difference (RD)|4.0||||1|TWO_SIDED|95.0|-18.7|26.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 52||26.6|-18.7|1.000
72354038|NCT02365649|144227488|SUPERIORITY||Risk Difference (RD)|5.0||||0.678|TWO_SIDED|95.0|-9.7|19.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 52||19.6|-9.7|0.678
72354039|NCT02365649|144227488|SUPERIORITY||Risk Difference (RD)|7.9||||0.636|TWO_SIDED|95.0|-10.5|26.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 52||26.2|-10.5|0.636
72354040|NCT02365649|144227488|SUPERIORITY||Risk Difference (RD)|21.4||||0.19|TWO_SIDED|95.0|-9.7|52.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 20||52.5|-9.7|0.190
72354041|NCT02365649|144227488|SUPERIORITY||Risk Difference (RD)|9.0||||0.504|TWO_SIDED|95.0|-17.3|35.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 20||35.3|-17.3|0.504
72354042|NCT02365649|144227488|SUPERIORITY||Risk Difference (RD)|1.6||||0.916|TWO_SIDED|95.0|-27.8|31.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 20||31.0|-27.8|0.916
72354043|NCT02365649|144227488|SUPERIORITY||Risk Difference (RD)|0.0||||1|TWO_SIDED|95.0|-31.7|31.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 28||31.7|-31.7|1.000
72354044|NCT02365649|144227488|SUPERIORITY||Risk Difference (RD)|-9.0||||0.504|TWO_SIDED|95.0|-35.3|17.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 28||17.3|-35.3|0.504
72354045|NCT02365649|144227488|SUPERIORITY||Risk Difference (RD)|-7.1||||0.635|TWO_SIDED|95.0|-36.6|22.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 28||22.3|-36.6|0.635
72354046|NCT02365649|144227488|SUPERIORITY||Risk Difference (RD)|10.7||||0.513|TWO_SIDED|95.0|-21.1|42.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 36||42.5|-21.1|0.513
72354047|NCT02365649|144227488|SUPERIORITY||Risk Difference (RD)|1.7||||0.898|TWO_SIDED|95.0|-24.7|28.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 36||28.1|-24.7|0.898
72354048|NCT02365649|144227488|SUPERIORITY||Risk Difference (RD)|-13.1||||0.379|TWO_SIDED|95.0|-41.7|15.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 36||15.5|-41.7|0.379
72354049|NCT02365649|144227488|SUPERIORITY||Risk Difference (RD)|-3.6||||0.822|TWO_SIDED|95.0|-34.5|27.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 44||27.4|-34.5|0.822
72354050|NCT02365649|144227488|SUPERIORITY||Risk Difference (RD)|8.9||||0.508|TWO_SIDED|95.0|-17.3|35.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 44||35.0|-17.3|0.508
72354051|NCT02365649|144227488|SUPERIORITY||Risk Difference (RD)|-6.0||||0.683|TWO_SIDED|95.0|-34.3|22.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 44||22.4|-34.3|0.683
72354052|NCT02365649|144227488|SUPERIORITY||Risk Difference (RD)|14.3||||0.49|TWO_SIDED|95.0|-16.6|45.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 52||45.1|-16.6|0.490
72354053|NCT02365649|144227488|SUPERIORITY||Risk Difference (RD)|23.3||||0.078|TWO_SIDED|95.0|-1.9|48.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5). Prespecified statistical significance at the 0.1 level.|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 52||48.5|-1.9|0.078
72354054|NCT02365649|144227488|SUPERIORITY||Risk Difference (RD)|10.3||||0.466|TWO_SIDED|95.0|-17.7|38.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 52||38.4|-17.7|0.466
72354055|NCT02365649|144227488|SUPERIORITY||Risk Difference (RD)|-5.9||||1|TWO_SIDED|95.0|-17.1|5.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 20||5.3|-17.1|1.000
72354056|NCT02365649|144227488|SUPERIORITY||Risk Difference (RD)|-5.9||||0.447|TWO_SIDED|95.0|-17.1|5.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 20||5.3|-17.1|0.447
72354057|NCT02365649|144227488|SUPERIORITY||Risk Difference (RD)|-5.9||||1|TWO_SIDED|95.0|-17.1|5.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 20||5.3|-17.1|1.000
72354058|NCT02365649|144227488|SUPERIORITY||Risk Difference (RD)|-11.8||||1|TWO_SIDED|95.0|-27.1|3.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 28||3.6|-27.1|1.000
72354059|NCT02365649|144227488|SUPERIORITY||Risk Difference (RD)|-11.8||||0.193|TWO_SIDED|95.0|-27.1|3.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 28||3.6|-27.1|0.193
72354060|NCT02365649|144227488|SUPERIORITY||Risk Difference (RD)|-11.8||||0.498|TWO_SIDED|95.0|-27.1|3.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 28||3.6|-27.1|0.498
72354061|NCT02365649|144227488|SUPERIORITY||Risk Difference (RD)|-5.9||||1|TWO_SIDED|95.0|-17.1|5.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 36||5.3|-17.1|1.000
72354062|NCT02365649|144227488|SUPERIORITY||Risk Difference (RD)|-5.9||||0.447|TWO_SIDED|95.0|-17.1|5.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 36||5.3|-17.1|0.447
72354063|NCT02365649|144227488|SUPERIORITY||Risk Difference (RD)|-5.9||||1|TWO_SIDED|95.0|-17.1|5.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 36||5.3|-17.1|1.000
72354064|NCT02365649|144227488|SUPERIORITY||Risk Difference (RD)|-5.9||||1|TWO_SIDED|95.0|-17.1|5.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 44||5.3|-17.1|1.000
72354065|NCT02365649|144227488|SUPERIORITY||Risk Difference (RD)|-5.9||||0.447|TWO_SIDED|95.0|-17.1|5.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 44||5.3|-17.1|0.447
72354066|NCT02365649|144227488|SUPERIORITY||Risk Difference (RD)|-5.9||||1|TWO_SIDED|95.0|-17.1|5.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 44||5.3|-17.1|1.000
72354067|NCT02365649|144227488|SUPERIORITY||Risk Difference (RD)|-5.9||||1|TWO_SIDED|95.0|-17.1|5.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 52||5.3|-17.1|1.000
72354068|NCT02365649|144227488|SUPERIORITY||Risk Difference (RD)|-1.1||||1|TWO_SIDED|95.0|-15.5|13.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 52||13.3|-15.5|1.000
72354069|NCT02365649|144227488|SUPERIORITY||Risk Difference (RD)|-5.9||||1|TWO_SIDED|95.0|-17.1|5.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 52||5.3|-17.1|1.000
72354070|NCT02365649|144227489|SUPERIORITY||Risk Difference (RD)|-6.7||||1|TWO_SIDED|95.0|-57.2|43.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 20||43.9|-57.2|1.000
72354071|NCT02365649|144227489|SUPERIORITY||Risk Difference (RD)|23.3||||0.323|TWO_SIDED|95.0|-9.2|55.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 20||55.8|-9.2|0.323
72354072|NCT02365649|144227489|SUPERIORITY||Risk Difference (RD)|33.3||||0.516|TWO_SIDED|95.0|6.7|60.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 20||60.0|6.7|0.516
72354073|NCT02365649|144227489|SUPERIORITY||Risk Difference (RD)|-31.7||||0.191|TWO_SIDED|95.0|-77.4|14.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 28||14.0|-77.4|0.191
72354074|NCT02365649|144227489|SUPERIORITY||Risk Difference (RD)|-1.7||||1|TWO_SIDED|95.0|-26.0|22.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 28||22.6|-26.0|1.000
72354075|NCT02365649|144227489|SUPERIORITY||Risk Difference (RD)|8.3||||1|TWO_SIDED|95.0|-7.3|24.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 28||24.0|-7.3|1.000
72354076|NCT02365649|144227489|SUPERIORITY||Risk Difference (RD)|33.3||||0.261|TWO_SIDED|95.0|6.7|60.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 36||60.0|6.7|0.261
72354077|NCT02365649|144227489|SUPERIORITY||Risk Difference (RD)|23.3||||0.323|TWO_SIDED|95.0|-9.2|55.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 36||55.8|-9.2|0.323
72354078|NCT02365649|144227489|SUPERIORITY||Risk Difference (RD)|8.3||||1|TWO_SIDED|95.0|-41.8|58.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 36||58.5|-41.8|1.000
72354079|NCT02365649|144227489|SUPERIORITY||Risk Difference (RD)|-26.7||||0.593|TWO_SIDED|95.0|-77.2|23.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 44||23.9|-77.2|0.593
72354080|NCT02365649|144227489|SUPERIORITY||Risk Difference (RD)|23.3||||0.323|TWO_SIDED|95.0|-9.2|55.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 44||55.8|-9.2|0.323
72354081|NCT02365649|144227489|SUPERIORITY||Risk Difference (RD)|8.3||||1|TWO_SIDED|95.0|-41.8|58.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 44||58.5|-41.8|1.000
72354082|NCT02365649|144227489|SUPERIORITY||Risk Difference (RD)|21.7||||0.6|TWO_SIDED|95.0|-23.1|66.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 52||66.5|-23.1|0.600
72354083|NCT02365649|144227489|SUPERIORITY||Risk Difference (RD)|31.7||||0.162|TWO_SIDED|95.0|-1.9|65.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 52||65.2|-1.9|0.162
72354084|NCT02365649|144227489|SUPERIORITY||Risk Difference (RD)|16.7||||1|TWO_SIDED|95.0|-34.1|67.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 52||67.4|-34.1|1.000
72354085|NCT02365649|144227489|SUPERIORITY||Risk Difference (RD)|13.3||||1|TWO_SIDED|95.0|-50.5|77.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 20||77.2|-50.5|1.000
72354086|NCT02365649|144227489|SUPERIORITY||Risk Difference (RD)|-16.7||||1|TWO_SIDED|95.0|-100.0|70.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 20||70.8|-100.0|1.000
72354087|NCT02365649|144227489|SUPERIORITY||Risk Difference (RD)|33.3||||1|TWO_SIDED|95.0|-20.0|86.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 20||86.7|-20.0|1.000
72354088|NCT02365649|144227489|SUPERIORITY||Risk Difference (RD)|-40.0||||0.464|TWO_SIDED|95.0|-82.9|2.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 28||2.9|-82.9|0.464
72354089|NCT02365649|144227489|SUPERIORITY||Risk Difference (RD)|-50.0||||0.4|TWO_SIDED|95.0|-100.0|19.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 28||19.3|-100.0|0.400
72354090|NCT02365649|144227489|SUPERIORITY||Risk Difference (RD)|-46.7||||0.464|TWO_SIDED|95.0|-100.0|17.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 36||17.2|-100.0|0.464
72354091|NCT02365649|144227489|SUPERIORITY||Risk Difference (RD)|-16.7||||1|TWO_SIDED|95.0|-100.0|70.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 36||70.8|-100.0|1.000
72354092|NCT02365649|144227489|SUPERIORITY||Risk Difference (RD)|33.3||||1|TWO_SIDED|95.0|-20.0|86.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 36||86.7|-20.0|1.000
72354093|NCT02365649|144227489|SUPERIORITY||Risk Difference (RD)|-26.7||||1|TWO_SIDED|95.0|-95.1|41.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 44||41.8|-95.1|1.000
72354094|NCT02365649|144227489|SUPERIORITY||Risk Difference (RD)|-16.7||||1|TWO_SIDED|95.0|-100.0|70.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 44||70.8|-100.0|1.000
72354095|NCT02365649|144227489|SUPERIORITY||Risk Difference (RD)|33.3||||1|TWO_SIDED|95.0|-20.0|86.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 44||86.7|-20.0|1.000
72354096|NCT02365649|144227489|SUPERIORITY||Risk Difference (RD)|-13.3||||1|TWO_SIDED|95.0|-77.2|50.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 52||50.5|-77.2|1.000
72354097|NCT02365649|144227489|SUPERIORITY||Risk Difference (RD)|16.7||||1|TWO_SIDED|95.0|-70.8|100.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 52||100.0|-70.8|1.000
72354098|NCT02365649|144227489|SUPERIORITY||Risk Difference (RD)|66.7||||1|TWO_SIDED|95.0|13.3|100.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 52||100.0|13.3|1.000
72354099|NCT02365649|144227489|SUPERIORITY||Risk Difference (RD)|3.3||||1|TWO_SIDED|95.0|-33.8|40.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 20||40.4|-33.8|1.000
72354100|NCT02365649|144227489|SUPERIORITY||Risk Difference (RD)|16.7||||0.408|TWO_SIDED|95.0|-15.2|48.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 20||48.5|-15.2|0.408
72354101|NCT02365649|144227489|SUPERIORITY||Risk Difference (RD)|33.3||||0.266|TWO_SIDED|95.0|9.5|57.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 20||57.2|9.5|0.266
72354102|NCT02365649|144227489|SUPERIORITY||Risk Difference (RD)|-33.3||||0.121|TWO_SIDED|95.0|-66.2|-0.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 28||-0.5|-66.2|0.121
72354103|NCT02365649|144227489|SUPERIORITY||Risk Difference (RD)|-10.0||||-10|TWO_SIDED|95.0|-34.6|14.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 28||14.6|-34.6|-10.0
72354104|NCT02365649|144227489|SUPERIORITY||Risk Difference (RD)|6.7||||1|TWO_SIDED|95.0|-6.0|19.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 28||19.3|-6.0|1.000
72354105|NCT02365649|144227489|SUPERIORITY||Risk Difference (RD)|-6.7||||1|TWO_SIDED|95.0|-45.3|31.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 36||31.9|-45.3|1.000
72354106|NCT02365649|144227489|SUPERIORITY||Risk Difference (RD)|16.7||||0.408|TWO_SIDED|95.0|-15.2|48.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 36||48.5|-15.2|0.408
72354107|NCT02365649|144227489|SUPERIORITY||Risk Difference (RD)|13.3||||1|TWO_SIDED|95.0|-29.1|55.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 36||55.7|-29.1|1.000
72354108|NCT02365649|144227489|SUPERIORITY||Risk Difference (RD)|-26.7||||0.241|TWO_SIDED|95.0|-65.3|11.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 44||11.9|-65.3|0.241
72354109|NCT02365649|144227489|SUPERIORITY||Risk Difference (RD)|16.7||||0.408|TWO_SIDED|95.0|-15.2|48.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 44||48.5|-15.2|0.408
72354110|NCT02365649|144227489|SUPERIORITY||Risk Difference (RD)|13.3||||1|TWO_SIDED|95.0|-29.1|55.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 44||55.7|-29.1|1.000
72354111|NCT02365649|144227489|SUPERIORITY||Risk Difference (RD)|-3.3||||1|TWO_SIDED|95.0|-43.3|36.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 52||36.6|-43.3|1.000
72354112|NCT02365649|144227489|SUPERIORITY||Risk Difference (RD)|30.0||||0.217|TWO_SIDED|95.0|-2.9|62.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 52||62.9|-2.9|0.217
72354113|NCT02365649|144227489|SUPERIORITY||Risk Difference (RD)|26.7||||0.603|TWO_SIDED|95.0|-16.5|69.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 52||69.9|-16.5|0.603
72354114|NCT02365649|144227490|SUPERIORITY||Risk Difference (RD)|12.5||||0.686|TWO_SIDED|95.0|-27.6|52.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders||52.6|-27.6|0.686
72354115|NCT02365649|144227490|SUPERIORITY||Risk Difference (RD)|18.8||||0.257|TWO_SIDED|95.0|-12.8|50.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders||50.3|-12.8|0.257
72354116|NCT02365649|144227490|SUPERIORITY||Risk Difference (RD)|-10.0||||0.709|TWO_SIDED|95.0|-47.4|27.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders||27.4|-47.4|0.709
72354117|NCT02365649|144227490|SUPERIORITY||Risk Difference (RD)|3.7||||1|TWO_SIDED|95.0|-16.6|24.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders||24.1|-16.6|1.000
72354118|NCT02365649|144227490|SUPERIORITY||Risk Difference (RD)|8.5||||0.428|TWO_SIDED|95.0|-6.1|23.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders||23.0|-6.1|0.428
72354119|NCT02365649|144227490|SUPERIORITY||Risk Difference (RD)|6.8||||0.639|TWO_SIDED|95.0|-9.3|22.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders||22.9|-9.3|0.639
72354120|NCT02365649|144227490|SUPERIORITY||Risk Difference (RD)|8.5||||0.583|TWO_SIDED|95.0|-22.2|39.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders||39.2|-22.2|0.583
72354121|NCT02365649|144227490|SUPERIORITY||Risk Difference (RD)|17.3||||0.171|TWO_SIDED|95.0|-7.2|41.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders||41.9|-7.2|0.171
72354122|NCT02365649|144227490|SUPERIORITY||Risk Difference (RD)|2.5||||0.859|TWO_SIDED|95.0|-24.8|29.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders||29.7|-24.8|0.859
72354123|NCT02365649|144227490|SUPERIORITY||Risk Difference (RD)|-5.0||||1|TWO_SIDED|95.0|-14.6|4.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders||4.6|-14.6|1.000
72354124|NCT02365649|144227490|SUPERIORITY||Risk Difference (RD)|-0.2||||1|TWO_SIDED|95.0|-13.4|13.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders||13.0|-13.4|1.000
72354125|NCT02365649|144227490|SUPERIORITY||Risk Difference (RD)|-5.0||||1|TWO_SIDED|95.0|-14.6|4.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders||4.6|-14.6|1.000
72354126|NCT02365649|144227491|SUPERIORITY||Risk Difference (RD)|2.5||||1|TWO_SIDED|95.0|-23.9|28.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders||28.9|-23.9|1.000
72354127|NCT02365649|144227491|SUPERIORITY||Risk Difference (RD)|21.3||||0.204|TWO_SIDED|95.0|-5.0|47.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders||47.5|-5.0|0.204
72354128|NCT02365649|144227491|SUPERIORITY||Risk Difference (RD)|-10.0||||0.54|TWO_SIDED|95.0|-23.1|3.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders||3.1|-23.1|0.540
72354129|NCT02365649|144227491|SUPERIORITY||Risk Difference (RD)|-6.3||||1|TWO_SIDED|95.0|-14.6|2.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders||2.1|-14.6|1.000
72354130|NCT02365649|144227491|SUPERIORITY||Risk Difference (RD)|2.6||||1|TWO_SIDED|95.0|-10.1|15.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders||15.3|-10.1|1.000
72354131|NCT02365649|144227491|SUPERIORITY||Risk Difference (RD)|2.4||||1|TWO_SIDED|95.0|-11.8|16.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders||16.7|-11.8|1.000
72354132|NCT02365649|144227491|SUPERIORITY||Risk Difference (RD)|0.9||||1|TWO_SIDED|95.0|-15.0|16.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders||16.8|-15.0|1.000
72354133|NCT02365649|144227491|SUPERIORITY||Risk Difference (RD)|14.4||||0.135|TWO_SIDED|95.0|-2.5|31.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders||31.4|-2.5|0.135
72354134|NCT02365649|144227491|SUPERIORITY||Risk Difference (RD)|4.3||||0.623|TWO_SIDED|95.0|-11.9|20.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders||20.4|-11.9|0.623
72354135|NCT02365649|144227491|SUPERIORITY||Risk Difference (RD)|-10.0||||1|TWO_SIDED|95.0|-23.1|3.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders||3.1|-23.1|1.000
72354136|NCT02365649|144227491|SUPERIORITY||Risk Difference (RD)|-0.5||||1|TWO_SIDED|95.0|-18.7|17.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders||17.7|-18.7|1.000
72354137|NCT02365649|144227491|SUPERIORITY||Risk Difference (RD)|-10.0||||0.501|TWO_SIDED|95.0|-23.1|3.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders||3.1|-23.1|0.501
72354138|NCT02365649|144227492|SUPERIORITY||Risk Difference (RD)|2.5||||1|TWO_SIDED|95.0|-23.9|28.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders||28.9|-23.9|1.000
72354139|NCT02365649|144227492|SUPERIORITY||Risk Difference (RD)|21.3||||0.204|TWO_SIDED|95.0|-5.0|47.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders||47.5|-5.0|0.204
72354140|NCT02365649|144227492|SUPERIORITY||Risk Difference (RD)|-10.0||||0.54|TWO_SIDED|95.0|-23.1|3.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders||3.1|-23.1|0.540
72354141|NCT02365649|144227492|SUPERIORITY||Risk Difference (RD)|-3.1||||1|TWO_SIDED|95.0|-9.2|2.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders||2.9|-9.2|1.000
72354142|NCT02365649|144227492|SUPERIORITY||Risk Difference (RD)|5.7||||0.614|TWO_SIDED|95.0|-5.6|17.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders||17.0|-5.6|0.614
72354143|NCT02365649|144227492|SUPERIORITY||Risk Difference (RD)|1.2||||1|TWO_SIDED|95.0|-9.1|11.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders||11.5|-9.1|1.000
72354144|NCT02365649|144227492|SUPERIORITY||Risk Difference (RD)|0.9||||1|TWO_SIDED|95.0|-15.0|16.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders||16.8|-15.0|1.000
72354145|NCT02365649|144227492|SUPERIORITY||Risk Difference (RD)|14.4||||0.135|TWO_SIDED|95.0|-2.5|31.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders||31.4|-2.5|0.135
72354146|NCT02365649|144227492|SUPERIORITY||Risk Difference (RD)|-1.0||||1|TWO_SIDED|95.0|-14.1|12.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders||12.1|-14.1|1.000
72354147|NCT02365649|144227492|SUPERIORITY||Risk Difference (RD)|-5.0||||1|TWO_SIDED|95.0|-14.6|4.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders||4.6|-14.6|1.000
72354148|NCT02365649|144227492|SUPERIORITY||Risk Difference (RD)|4.5||||1|TWO_SIDED|95.0|-11.3|20.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders||20.3|-11.3|1.000
72354149|NCT02365649|144227492|SUPERIORITY||Risk Difference (RD)|-5.0||||1|TWO_SIDED|95.0|-14.6|4.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders||4.6|-14.6|1.000
72354150|NCT02365649|144227493|SUPERIORITY||Risk Difference (RD)|15.0||||0.669|TWO_SIDED|95.0|-21.9|51.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders||51.9|-21.9|0.669
72354151|NCT02365649|144227493|SUPERIORITY||Risk Difference (RD)|15.0||||0.343|TWO_SIDED|95.0|-15.2|45.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders||45.2|-15.2|0.343
72354152|NCT02365649|144227493|SUPERIORITY||Risk Difference (RD)|-20.0||||0.442|TWO_SIDED|95.0|-57.2|17.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders||17.2|-57.2|0.442
72354153|NCT02365649|144227493|SUPERIORITY||Risk Difference (RD)|4.4||||1|TWO_SIDED|95.0|-23.4|32.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders||32.2|-23.4|1.000
72354154|NCT02365649|144227493|SUPERIORITY||Risk Difference (RD)|5.0||||0.601|TWO_SIDED|95.0|-13.6|23.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders||23.5|-13.6|0.601
72354155|NCT02365649|144227493|SUPERIORITY||Risk Difference (RD)|1.8||||1|TWO_SIDED|95.0|-18.2|21.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders||21.7|-18.2|1.000
72354156|NCT02365649|144227493|SUPERIORITY||Risk Difference (RD)|16.5||||0.301|TWO_SIDED|95.0|-14.5|47.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders||47.5|-14.5|0.301
72354157|NCT02365649|144227493|SUPERIORITY||Risk Difference (RD)|14.5||||0.256|TWO_SIDED|95.0|-10.3|39.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders||39.4|-10.3|0.256
72354158|NCT02365649|144227493|SUPERIORITY||Risk Difference (RD)|1.5||||0.917|TWO_SIDED|95.0|-26.5|29.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders||29.5|-26.5|0.917
72354159|NCT02365649|144227493|SUPERIORITY||Risk Difference (RD)|-20.2||||1|TWO_SIDED|95.0|-37.5|-2.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders||-2.5|-37.5|1.000
72354160|NCT02365649|144227493|SUPERIORITY||Risk Difference (RD)|-5.7||||0.697|TWO_SIDED|95.0|-28.8|17.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders||17.3|-28.8|0.697
72354161|NCT02365649|144227493|SUPERIORITY||Risk Difference (RD)|-20.0||||0.126|TWO_SIDED|95.0|-37.5|-2.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders||-2.5|-37.5|0.126
72354162|NCT02365649|144227494|SUPERIORITY||Risk Difference (RD)|10.0||||0.691|TWO_SIDED|95.0|-30.8|50.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders||50.8|-30.8|0.691
72354163|NCT02365649|144227494|SUPERIORITY||Risk Difference (RD)|28.8||||0.086|TWO_SIDED|95.0|-2.5|60.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5). Prespecified statistical significance at the 0.1 level.|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders||60.0|-2.5|0.086
72354164|NCT02365649|144227494|SUPERIORITY||Risk Difference (RD)|-10.0||||0.702|TWO_SIDED|95.0|-45.6|25.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders||25.6|-45.6|0.702
72354165|NCT02365649|144227494|SUPERIORITY||Risk Difference (RD)|-12.5||||0.557|TWO_SIDED|95.0|-24.0|-1.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders||-1.0|-24.0|0.557
72354166|NCT02365649|144227494|SUPERIORITY||Risk Difference (RD)|-0.7||||1|TWO_SIDED|95.0|-16.5|15.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders||15.0|-16.5|1.000
72354167|NCT02365649|144227494|SUPERIORITY||Risk Difference (RD)|4.9||||0.707|TWO_SIDED|95.0|-14.4|24.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders||24.2|-14.4|0.707
72354168|NCT02365649|144227494|SUPERIORITY||Risk Difference (RD)|0.4||||1|TWO_SIDED|95.0|-27.9|28.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders||28.8|-27.9|1.000
72354169|NCT02365649|144227494|SUPERIORITY||Risk Difference (RD)|16.7||||0.175|TWO_SIDED|95.0|-7.2|40.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders||40.6|-7.2|0.175
72354170|NCT02365649|144227494|SUPERIORITY||Risk Difference (RD)|8.7||||0.517|TWO_SIDED|95.0|-18.0|35.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders||35.4|-18.0|0.517
72354171|NCT02365649|144227494|SUPERIORITY||Risk Difference (RD)|-15.0||||1|TWO_SIDED|95.0|-30.6|0.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders||0.6|-30.6|1.000
72354172|NCT02365649|144227494|SUPERIORITY||Risk Difference (RD)|-5.5||||0.663|TWO_SIDED|95.0|-25.5|14.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders||14.6|-25.5|0.663
72354173|NCT02365649|144227494|SUPERIORITY||Risk Difference (RD)|-15.0||||0.251|TWO_SIDED|95.0|-30.6|0.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders||0.6|-30.6|0.251
72354174|NCT02365649|144227495|SUPERIORITY||Risk Difference (RD)|0.0||||1|TWO_SIDED|95.0|-41.0|41.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders||41.0|-41.0|1.000
72354175|NCT02365649|144227495|SUPERIORITY||Risk Difference (RD)|18.8||||0.257|TWO_SIDED|95.0|-12.8|50.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders||50.3|-12.8|0.257
72354176|NCT02365649|144227495|SUPERIORITY||Risk Difference (RD)|-20.0||||0.44|TWO_SIDED|95.0|-55.9|15.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders||15.9|-55.9|0.440
72354177|NCT02365649|144227495|SUPERIORITY||Risk Difference (RD)|-2.5||||1|TWO_SIDED|95.0|-24.3|19.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders||19.3|-24.3|1.000
72354178|NCT02365649|144227495|SUPERIORITY||Risk Difference (RD)|-0.7||||1|TWO_SIDED|95.0|-16.5|15.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders||15.0|-16.5|1.000
72354179|NCT02365649|144227495|SUPERIORITY||Risk Difference (RD)|-20.0||||0.44|TWO_SIDED|95.0|-55.9|15.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders||15.9|-55.9|0.440
72354180|NCT02365649|144227495|SUPERIORITY||Risk Difference (RD)|1.3||||1|TWO_SIDED|95.0|-28.7|31.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders||31.4|-28.7|1.000
72354181|NCT02365649|144227495|SUPERIORITY||Risk Difference (RD)|10.5||||0.404|TWO_SIDED|95.0|-14.0|34.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders||34.9|-14.0|0.404
72354182|NCT02365649|144227495|SUPERIORITY||Risk Difference (RD)|2.5||||0.859|TWO_SIDED|95.0|-24.8|29.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders||29.7|-24.8|0.859
72354183|NCT02365649|144227495|SUPERIORITY||Risk Difference (RD)|-15.0||||1|TWO_SIDED|95.0|-30.6|0.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders||0.6|-30.6|1.000
72354184|NCT02365649|144227495|SUPERIORITY||Risk Difference (RD)|-5.5||||0.663|TWO_SIDED|95.0|-25.5|14.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders||14.6|-25.5|0.663
72354185|NCT02365649|144227495|SUPERIORITY||Risk Difference (RD)|-15.0||||0.251|TWO_SIDED|95.0|-30.6|0.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders||0.6|-30.6|0.251
72354186|NCT02365649|144227496|SUPERIORITY||Risk Difference (RD)|10.0||||0.606|TWO_SIDED|95.0|-23.8|43.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders||43.8|-23.8|0.606
72354187|NCT02365649|144227496|SUPERIORITY||Risk Difference (RD)|35.0||||0.034|TWO_SIDED|95.0|5.9|64.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5). Prespecified significant at the 0.5 level.|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders||64.1|5.9|0.034
72354188|NCT02365649|144227496|SUPERIORITY||Risk Difference (RD)|-15.0||||0.532|TWO_SIDED|95.0|-30.6|0.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders||0.6|-30.6|0.532
72354189|NCT02365649|144227496|SUPERIORITY||Risk Difference (RD)|0.6||||1|TWO_SIDED|95.0|-20.5|21.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders||21.8|-20.5|1.000
72354190|NCT02365649|144227496|SUPERIORITY||Risk Difference (RD)|-0.6||||1|TWO_SIDED|95.0|-14.4|13.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders||13.3|-14.4|1.000
72354191|NCT02365649|144227496|SUPERIORITY||Risk Difference (RD)|-0.7||||1|TWO_SIDED|95.0|-16.0|14.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders||14.6|-16.0|1.000
72354192|NCT02365649|144227496|SUPERIORITY||Risk Difference (RD)|12.1||||0.35|TWO_SIDED|95.0|-11.7|35.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders||35.8|-11.7|0.350
72354193|NCT02365649|144227496|SUPERIORITY||Risk Difference (RD)|21.7||||0.034|TWO_SIDED|95.0|2.0|41.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5). Prespecified significant at the 0.5 level.|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders||41.3|2.0|0.034
72354194|NCT02365649|144227496|SUPERIORITY||Risk Difference (RD)|1.2||||1|TWO_SIDED|95.0|-15.9|18.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders||18.3|-15.9|1.000
72354195|NCT02365649|144227496|SUPERIORITY||Risk Difference (RD)|-15.0||||1|TWO_SIDED|95.0|-30.6|0.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders||0.6|-30.6|1.000
72354196|NCT02365649|144227496|SUPERIORITY||Risk Difference (RD)|-5.5||||0.663|TWO_SIDED|95.0|-25.5|14.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders||14.6|-25.5|0.663
72354197|NCT02365649|144227496|SUPERIORITY||Risk Difference (RD)|-15.0||||0.251|TWO_SIDED|95.0|-30.6|0.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders||0.6|-30.6|0.251
72354198|NCT02365649|144227497|SUPERIORITY||Risk Difference (RD)|15.0||||0.536|TWO_SIDED|95.0|-0.6|30.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 20||30.6|-0.6|0.536
72354199|NCT02365649|144227497|SUPERIORITY||Risk Difference (RD)|15.0||||0.238|TWO_SIDED|95.0|-0.6|30.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 20||30.6|-0.6|0.238
72354200|NCT02365649|144227497|SUPERIORITY||Risk Difference (RD)|-5.0||||1|TWO_SIDED|95.0|-34.3|24.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 20||24.3|-34.3|1.000
72354201|NCT02365649|144227497|SUPERIORITY||Risk Difference (RD)|-10.0||||0.606|TWO_SIDED|95.0|-43.8|23.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 28||23.8|-43.8|0.606
72354202|NCT02365649|144227497|SUPERIORITY||Risk Difference (RD)|-3.8||||1|TWO_SIDED|95.0|-28.5|21.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 28||21.0|-28.5|1.000
72429209|NCT01058863|144369415|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|33.1|STANDARD_ERROR_OF_MEAN|3.686|<|0.0001|TWO_SIDED|95.0|25.84|40.35||Significance at the 0.05 level.|ANOVA|Fixed effects of baseline PPFEV1 as a covariate, sequence, treatment group, period, and center, and random effect for subject within sequence.||Of interest was the mean difference between each active group and placebo at each dose level. Analyses were performed at the 2-sided 0.05 significance level in this sequence: Albuterol Spiromax 180 mcg versus placebo; Albuterol Spiromax 90 mcg versus placebo, ProAir HFA 180 mcg versus placebo, and ProAir HFA 90 mcg versus placebo. If a test was not significant, no further tests were done. This sequential procedure preserved the error rate for the family of tests at the 0.05 level.||40.35|25.84|<0.0001
72354203|NCT02365649|144227497|SUPERIORITY||Risk Difference (RD)|-25.0||||0.181|TWO_SIDED|95.0|-59.2|9.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 28||9.2|-59.2|0.181
72354204|NCT02365649|144227497|SUPERIORITY||Risk Difference (RD)|25.0||||0.281|TWO_SIDED|95.0|6.0|44.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 36||44.0|6.0|0.281
72354205|NCT02365649|144227497|SUPERIORITY||Risk Difference (RD)|0.0||||1|TWO_SIDED|95.0|-28.5|28.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 36||28.5|-28.5|1.000
72354206|NCT02365649|144227497|SUPERIORITY||Risk Difference (RD)|-25.0||||0.231|TWO_SIDED|95.0|-61.3|11.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 36||11.3|-61.3|0.231
72354207|NCT02365649|144227497|SUPERIORITY||Risk Difference (RD)|37.5||||0.099|TWO_SIDED|95.0|5.8|69.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5). Prespecified significance at the 0.1 level.|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 44||69.2|5.8|0.099
72354208|NCT02365649|144227497|SUPERIORITY||Risk Difference (RD)|31.3||||0.052|TWO_SIDED|95.0|2.2|60.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5). Prespecified significance at the 0.1 level.|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 44||60.3|2.2|0.052
72354209|NCT02365649|144227497|SUPERIORITY||Risk Difference (RD)|-10.0||||0.709|TWO_SIDED|95.0|-47.4|27.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 44||27.4|-47.4|0.709
72354210|NCT02365649|144227497|SUPERIORITY||Risk Difference (RD)|32.5||||0.194|TWO_SIDED|95.0|0.9|64.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 52||64.1|0.9|0.194
72354211|NCT02365649|144227497|SUPERIORITY||Risk Difference (RD)|13.8||||0.4|TWO_SIDED|95.0|-17.7|45.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 52||45.2|-17.7|0.400
72354212|NCT02365649|144227497|SUPERIORITY||Risk Difference (RD)|-5.0||||1|TWO_SIDED|95.0|-42.9|32.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 52||32.9|-42.9|1.000
72354213|NCT02365649|144227497|SUPERIORITY||Risk Difference (RD)|16.3||||0.477|TWO_SIDED|95.0|-18.6|51.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 20||51.1|-18.6|0.477
72354214|NCT02365649|144227497|SUPERIORITY||Risk Difference (RD)|-2.6||||0.833|TWO_SIDED|95.0|-26.4|21.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 20||21.3|-26.4|0.833
72354215|NCT02365649|144227497|SUPERIORITY||Risk Difference (RD)|-4.6||||0.732|TWO_SIDED|95.0|-30.9|21.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 20||21.7|-30.9|0.732
72354216|NCT02365649|144227497|SUPERIORITY||Risk Difference (RD)|19.4||||0.468|TWO_SIDED|95.0|-15.4|54.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 28||54.2|-15.4|0.468
72354217|NCT02365649|144227497|SUPERIORITY||Risk Difference (RD)|-11.2||||0.339|TWO_SIDED|95.0|-34.1|11.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 28||11.7|-34.1|0.339
72354218|NCT02365649|144227497|SUPERIORITY||Risk Difference (RD)|-14.5||||0.263|TWO_SIDED|95.0|-39.3|10.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 28||10.2|-39.3|0.263
72354219|NCT02365649|144227497|SUPERIORITY||Risk Difference (RD)|11.9||||0.697|TWO_SIDED|95.0|-22.3|46.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 36||46.0|-22.3|0.697
72354220|NCT02365649|144227497|SUPERIORITY||Risk Difference (RD)|-1.7||||0.88|TWO_SIDED|95.0|-23.2|19.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 36||19.9|-23.2|0.880
72354221|NCT02365649|144227497|SUPERIORITY||Risk Difference (RD)|-10.7||||0.355|TWO_SIDED|95.0|-32.7|11.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 36||11.2|-32.7|0.355
72354222|NCT02365649|144227497|SUPERIORITY||Risk Difference (RD)|5.0||||1|TWO_SIDED|95.0|-27.1|37.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 44||37.1|-27.1|1.000
72354223|NCT02365649|144227497|SUPERIORITY||Risk Difference (RD)|1.5||||0.891|TWO_SIDED|95.0|-19.6|22.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 44||22.6|-19.6|0.891
72354224|NCT02365649|144227497|SUPERIORITY||Risk Difference (RD)|-3.3||||0.779|TWO_SIDED|95.0|-25.8|19.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 44||19.3|-25.8|0.779
72354225|NCT02365649|144227497|SUPERIORITY||Risk Difference (RD)|8.1||||0.678|TWO_SIDED|95.0|-23.7|39.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 52||39.9|-23.7|0.678
72354226|NCT02365649|144227497|SUPERIORITY||Risk Difference (RD)|4.6||||0.663|TWO_SIDED|95.0|-16.0|25.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 52||25.2|-16.0|0.663
72354227|NCT02365649|144227497|SUPERIORITY||Risk Difference (RD)|-8.8||||0.494|TWO_SIDED|95.0|-28.7|11.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 52||11.0|-28.7|0.494
72354228|NCT02365649|144227497|SUPERIORITY||Risk Difference (RD)|21.9||||0.083|TWO_SIDED|95.0|7.6|36.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5). Prespecified significance at the 0.1 level.|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 20||36.2|7.6|0.083
72354229|NCT02365649|144227497|SUPERIORITY||Risk Difference (RD)|15.0||||0.151|TWO_SIDED|95.0|-2.1|32.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 20||32.0|-2.1|0.151
72354230|NCT02365649|144227497|SUPERIORITY||Risk Difference (RD)|0.8||||1|TWO_SIDED|95.0|-22.4|24.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 20||24.1|-22.4|1.000
72354231|NCT02365649|144227497|SUPERIORITY||Risk Difference (RD)|0.4||||1|TWO_SIDED|95.0|-25.4|26.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 28||26.3|-25.4|1.000
72354232|NCT02365649|144227497|SUPERIORITY||Risk Difference (RD)|-9.2||||0.417|TWO_SIDED|95.0|-31.3|12.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 28||12.9|-31.3|0.417
72429210|NCT01058863|144369415|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|25.61|STANDARD_ERROR_OF_MEAN|3.68|<|0.0001|TWO_SIDED|95.0|18.36|32.85||Significance at the 0.05 level.|ANOVA|Fixed effects of baseline PPFEV1 as a covariate, sequence, treatment group, period, and center, and random effect for subject within sequence.||Of interest was the mean difference between each active group and placebo at each dose level. Analyses were performed at the 2-sided 0.05 significance level in this sequence: Albuterol Spiromax 180 mcg versus placebo; Albuterol Spiromax 90 mcg versus placebo, ProAir HFA 180 mcg versus placebo, and ProAir HFA 90 mcg versus placebo. If a test was not significant, no further tests were done. This sequential procedure preserved the error rate for the family of tests at the 0.05 level.||32.85|18.36|<0.0001
72354233|NCT02365649|144227497|SUPERIORITY||Risk Difference (RD)|-20.2||||0.125|TWO_SIDED|95.0|-46.7|6.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 28||6.2|-46.7|0.125
72354234|NCT02365649|144227497|SUPERIORITY||Risk Difference (RD)|12.9||||0.497|TWO_SIDED|95.0|-14.1|40.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 36||40.0|-14.1|0.497
72354235|NCT02365649|144227497|SUPERIORITY||Risk Difference (RD)|-0.1||||0.993|TWO_SIDED|95.0|-24.0|23.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 36||23.8|-24.0|0.993
72354236|NCT02365649|144227497|SUPERIORITY||Risk Difference (RD)|-18.3||||0.2|TWO_SIDED|95.0|-46.1|9.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 36||9.6|-46.1|0.200
72354237|NCT02365649|144227497|SUPERIORITY||Risk Difference (RD)|21.4||||0.177|TWO_SIDED|95.0|-7.9|50.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 44||50.8|-7.9|0.177
72354238|NCT02365649|144227497|SUPERIORITY||Risk Difference (RD)|22.4||||0.074|TWO_SIDED|95.0|-1.4|46.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5). Prespecified significance at the 0.1 level.|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 44||46.2|-1.4|0.074
72354239|NCT02365649|144227497|SUPERIORITY||Risk Difference (RD)|-7.9||||0.585|TWO_SIDED|95.0|-36.1|20.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 44||20.3|-36.1|0.585
72354240|NCT02365649|144227497|SUPERIORITY||Risk Difference (RD)|21.4||||0.177|TWO_SIDED|95.0|-7.9|50.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 52||50.8|-7.9|0.177
72354241|NCT02365649|144227497|SUPERIORITY||Risk Difference (RD)|12.1||||0.343|TWO_SIDED|95.0|-12.7|36.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 52||36.8|-12.7|0.343
72354242|NCT02365649|144227497|SUPERIORITY||Risk Difference (RD)|-7.9||||0.585|TWO_SIDED|95.0|-36.1|20.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 52||20.3|-36.1|0.585
72354243|NCT02365649|144227497|SUPERIORITY||Risk Difference (RD)|-30.0||||0.539|TWO_SIDED|95.0|-50.1|-9.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 20||-9.9|-50.1|0.539
72354244|NCT02365649|144227497|SUPERIORITY||Risk Difference (RD)|-15.7||||0.277|TWO_SIDED|95.0|-40.8|9.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 20||9.3|-40.8|0.277
72354245|NCT02365649|144227497|SUPERIORITY||Risk Difference (RD)|-15.7||||0.422|TWO_SIDED|95.0|-42.9|11.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 20||11.5|-42.9|0.422
72354246|NCT02365649|144227497|SUPERIORITY||Risk Difference (RD)|0.0||||1|TWO_SIDED|95.0|-46.5|46.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 28||46.5|-46.5|1.000
72354247|NCT02365649|144227497|SUPERIORITY||Risk Difference (RD)|-10.7||||0.454|TWO_SIDED|95.0|-34.9|13.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 28||13.5|-34.9|0.454
72429211|NCT04230980|144369434|SUPERIORITY||Mean Difference (Final Values)|-1.13||||0.01|TWO_SIDED|95.0|-2.02|-0.24|||t-test, 2 sided||Direction of mean difference is Gabapentin arm minus placebo arm.|Mean NRS-11 score at post-operative day 7 (compared between the two arms).||-0.24|-2.02|0.01
72354248|NCT02365649|144227497|SUPERIORITY||Risk Difference (RD)|-17.9||||0.364|TWO_SIDED|95.0|-41.1|5.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 28||5.4|-41.1|0.364
72354249|NCT02365649|144227497|SUPERIORITY||Risk Difference (RD)|10.0||||0.544|TWO_SIDED|95.0|-35.2|55.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 36||55.2|-35.2|0.544
72354250|NCT02365649|144227497|SUPERIORITY||Risk Difference (RD)|-5.5||||0.663|TWO_SIDED|95.0|-25.5|14.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 36||14.6|-25.5|0.663
72354251|NCT02365649|144227497|SUPERIORITY||Risk Difference (RD)|-15.0||||0.251|TWO_SIDED|95.0|-30.6|0.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 36||0.6|-30.6|0.251
72354252|NCT02365649|144227497|SUPERIORITY||Risk Difference (RD)|-10.0||||1|TWO_SIDED|95.0|-23.1|3.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared|||Clinical non-responders, Week 44||3.1|-23.1|1.000
72354253|NCT02365649|144227497|SUPERIORITY||Risk Difference (RD)|-5.2||||0.606|TWO_SIDED|95.0|-21.2|10.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 44||10.8|-21.2|0.606
72354254|NCT02365649|144227497|SUPERIORITY||Risk Difference (RD)|-2.9||||1|TWO_SIDED|95.0|-21.7|16.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 44||16.0|-21.7|1.000
72354255|NCT02365649|144227497|SUPERIORITY||Risk Difference (RD)|-10.0||||1|TWO_SIDED|95.0|-23.1|3.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 52||3.1|-23.1|1.000
72354256|NCT02365649|144227497|SUPERIORITY||Risk Difference (RD)|-0.5||||1|TWO_SIDED|95.0|-18.7|17.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 52||17.7|-18.7|1.000
72354257|NCT02365649|144227497|SUPERIORITY||Risk Difference (RD)|-10.0||||0.501|TWO_SIDED|95.0|-23.1|3.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 52||3.1|-23.1|0.501
72354258|NCT02365649|144227498|SUPERIORITY||Risk Difference (RD)|17.5||||0.633|TWO_SIDED|95.0|-13.0|48.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 20||48.0|-13.0|0.633
72354259|NCT02365649|144227498|SUPERIORITY||Risk Difference (RD)|30.0||||0.0024|TWO_SIDED|95.0|9.9|50.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 20||50.1|9.9|0.0024
72354260|NCT02365649|144227498|SUPERIORITY||Risk Difference (RD)|0.0||||1|TWO_SIDED|95.0|-34.8|34.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 20||34.8|-34.8|1.000
72354261|NCT02365649|144227498|SUPERIORITY||Risk Difference (RD)|-5.0||||1|TWO_SIDED|95.0|-39.8|29.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 28||29.8|-39.8|1.000
72354262|NCT02365649|144227498|SUPERIORITY||Risk Difference (RD)|1.3||||1|TWO_SIDED|95.0|-24.7|27.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 28||27.2|-24.7|1.000
72429212|NCT04230980|144369435|SUPERIORITY||Mean Difference (Final Values)|-0.05||||0.19|TWO_SIDED|95.0|-0.13|0.03|||t-test, 2 sided||Direction of mean difference is Gabapentin arm minus placebo arm.|Mean number of opioid tablets taken at post-operative day 7 (compared between the two arms).||0.03|-0.13|0.19
72429213|NCT00598481|144369448|SUPERIORITY|||||||0.005|||||||One-sided Poisson-regression|||||||0.005
72429214|NCT00598481|144369449|SUPERIORITY||Geometric mean ratio|3.0||||0.003|TWO_SIDED|95.0|1.45|6.19||P value related to geometric mean ratio at 1 year post gene therapy compared to baseline|Mixed Model Repeated Measures|||||6.19|1.45|0.003
72354263|NCT02365649|144227498|SUPERIORITY||Risk Difference (RD)|-20.0||||0.384|TWO_SIDED|95.0|-55.1|15.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 28||15.1|-55.1|0.384
72354264|NCT02365649|144227498|SUPERIORITY||Risk Difference (RD)|25.0||||0.281|TWO_SIDED|95.0|6.0|44.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 36||44.0|6.0|0.281
72354265|NCT02365649|144227498|SUPERIORITY||Risk Difference (RD)|0.0||||1|TWO_SIDED|95.0|-28.5|28.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 36||28.5|-28.5|1.000
72354266|NCT02365649|144227498|SUPERIORITY||Risk Difference (RD)|-35.0||||0.108|TWO_SIDED|95.0|-70.8|0.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 36||0.8|-70.8|0.108
72354267|NCT02365649|144227498|SUPERIORITY||Risk Difference (RD)|12.5||||0.686|TWO_SIDED|95.0|-27.6|52.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 44||52.6|-27.6|0.686
72354268|NCT02365649|144227498|SUPERIORITY||Risk Difference (RD)|25.0||||0.126|TWO_SIDED|95.0|-5.5|55.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 44||55.5|-5.5|0.126
72354269|NCT02365649|144227498|SUPERIORITY||Risk Difference (RD)|-10.0||||0.709|TWO_SIDED|95.0|-47.4|27.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 44||27.4|-47.4|0.709
72354270|NCT02365649|144227498|SUPERIORITY||Risk Difference (RD)|37.5||||0.099|TWO_SIDED|95.0|5.8|69.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 52||69.2|5.8|0.099
72354271|NCT02365649|144227498|SUPERIORITY||Risk Difference (RD)|18.8||||0.257|TWO_SIDED|95.0|-12.8|50.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 52||50.3|-12.8|0.257
72354272|NCT02365649|144227498|SUPERIORITY||Risk Difference (RD)|0.0||||1|TWO_SIDED|95.0|-38.0|38.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 52||38.0|-38.0|1.000
72354273|NCT02365649|144227498|SUPERIORITY||Risk Difference (RD)|15.6||||0.465|TWO_SIDED|95.0|-19.5|50.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 20||50.7|-19.5|0.465
72354274|NCT02365649|144227498|SUPERIORITY||Risk Difference (RD)|3.9||||0.745|TWO_SIDED|95.0|-19.3|27.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 20||27.0|-19.3|0.745
72354275|NCT02365649|144227498|SUPERIORITY||Risk Difference (RD)|-8.3||||0.512|TWO_SIDED|95.0|-32.6|16.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 20||16.1|-32.6|0.512
72354276|NCT02365649|144227498|SUPERIORITY||Risk Difference (RD)|22.5||||0.281|TWO_SIDED|95.0|-12.2|57.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 28||57.2|-12.2|0.281
72354277|NCT02365649|144227498|SUPERIORITY||Risk Difference (RD)|-8.1||||0.486|TWO_SIDED|95.0|-30.8|14.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 28||14.6|-30.8|0.486
72354278|NCT02365649|144227498|SUPERIORITY||Risk Difference (RD)|-15.8||||0.212|TWO_SIDED|95.0|-39.5|8.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 28||8.0|-39.5|0.212
72354279|NCT02365649|144227498|SUPERIORITY||Risk Difference (RD)|11.9||||0.697|TWO_SIDED|95.0|-22.3|46.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 36||46.0|-22.3|0.697
72354280|NCT02365649|144227498|SUPERIORITY||Risk Difference (RD)|-1.7||||0.88|TWO_SIDED|95.0|-23.2|19.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 36||19.9|-23.2|0.880
72354281|NCT02365649|144227498|SUPERIORITY||Risk Difference (RD)|-10.7||||0.355|TWO_SIDED|95.0|-32.7|11.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 36||11.2|-32.7|0.355
72354282|NCT02365649|144227498|SUPERIORITY||Risk Difference (RD)|8.1||||0.678|TWO_SIDED|95.0|-23.7|39.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 44||39.9|-23.7|0.678
72354283|NCT02365649|144227498|SUPERIORITY||Risk Difference (RD)|1.7||||0.873|TWO_SIDED|95.0|-18.6|21.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 44||21.9|-18.6|0.873
72354284|NCT02365649|144227498|SUPERIORITY||Risk Difference (RD)|-0.1||||0.99|TWO_SIDED|95.0|-22.3|22.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 44||22.0|-22.3|0.990
72354285|NCT02365649|144227498|SUPERIORITY||Risk Difference (RD)|8.1||||0.678|TWO_SIDED|95.0|-23.7|39.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 52||39.9|-23.7|0.678
72354286|NCT02365649|144227498|SUPERIORITY||Risk Difference (RD)|4.6||||0.663|TWO_SIDED|95.0|-16.0|25.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 52||25.2|-16.0|0.663
72354287|NCT02365649|144227498|SUPERIORITY||Risk Difference (RD)|-8.8||||0.494|TWO_SIDED|95.0|-28.7|11.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 52||11.0|-28.7|0.494
72354288|NCT02365649|144227498|SUPERIORITY||Risk Difference (RD)|23.2||||0.169|TWO_SIDED|95.0|-1.6|48.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 20||48.1|-1.6|0.169
72354289|NCT02365649|144227498|SUPERIORITY||Risk Difference (RD)|30.6||||0.005|TWO_SIDED|95.0|11.5|49.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 20||49.7|11.5|0.005
72354290|NCT02365649|144227498|SUPERIORITY||Risk Difference (RD)|0.7||||0.963|TWO_SIDED|95.0|-26.8|28.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 20||28.1|-26.8|0.963
72354291|NCT02365649|144227498|SUPERIORITY||Risk Difference (RD)|6.7||||0.729|TWO_SIDED|95.0|-19.8|33.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 28||33.2|-19.8|0.729
72354292|NCT02365649|144227498|SUPERIORITY||Risk Difference (RD)|-2.9||||0.804|TWO_SIDED|95.0|-25.8|20.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 28||20.0|-25.8|0.804
72354293|NCT02365649|144227498|SUPERIORITY||Risk Difference (RD)|-14.0||||0.306|TWO_SIDED|95.0|-41.1|13.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 28||13.1|-41.1|0.306
72354294|NCT02365649|144227498|SUPERIORITY||Risk Difference (RD)|12.9||||0.497|TWO_SIDED|95.0|-14.1|40.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 36||40.0|-14.1|0.497
72354295|NCT02365649|144227498|SUPERIORITY||Risk Difference (RD)|-0.1||||0.993|TWO_SIDED|95.0|-24.0|23.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 36||23.8|-24.0|0.993
72354296|NCT02365649|144227498|SUPERIORITY||Risk Difference (RD)|-23.5||||0.101|TWO_SIDED|95.0|-51.2|4.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 36||4.1|-51.2|0.101
72354297|NCT02365649|144227498|SUPERIORITY||Risk Difference (RD)|7.1||||0.655|TWO_SIDED|95.0|-24.0|38.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 44||38.3|-24.0|0.655
72354298|NCT02365649|144227498|SUPERIORITY||Risk Difference (RD)|15.5||||0.221|TWO_SIDED|95.0|-9.0|40.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 44||40.0|-9.0|0.221
72354299|NCT02365649|144227498|SUPERIORITY||Risk Difference (RD)|-7.9||||0.585|TWO_SIDED|95.0|-36.1|20.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 44||20.3|-36.1|0.585
72354300|NCT02365649|144227498|SUPERIORITY||Risk Difference (RD)|24.6||||0.124|TWO_SIDED|95.0|-4.8|53.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 52||53.9|-4.8|0.124
72354301|NCT02365649|144227498|SUPERIORITY||Risk Difference (RD)|15.2||||0.234|TWO_SIDED|95.0|-9.5|39.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 52||39.9|-9.5|0.234
72354302|NCT02365649|144227498|SUPERIORITY||Risk Difference (RD)|-4.8||||0.741|TWO_SIDED|95.0|-32.9|23.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 52||23.4|-32.9|0.741
72354303|NCT02365649|144227498|SUPERIORITY||Risk Difference (RD)|-25.0||||0.544|TWO_SIDED|95.0|-44.0|-6.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 20||-6.0|-44.0|0.544
72354304|NCT02365649|144227498|SUPERIORITY||Risk Difference (RD)|-15.5||||0.238|TWO_SIDED|95.0|-38.2|7.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 20||7.3|-38.2|0.238
72354305|NCT02365649|144227498|SUPERIORITY||Risk Difference (RD)|-17.9||||0.364|TWO_SIDED|95.0|-41.1|5.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 20||5.4|-41.1|0.364
72354306|NCT02365649|144227498|SUPERIORITY||Risk Difference (RD)|0.0||||1|TWO_SIDED|95.0|-46.5|46.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 28||46.5|-46.5|1.000
72354307|NCT02365649|144227498|SUPERIORITY||Risk Difference (RD)|-10.7||||0.454|TWO_SIDED|95.0|-34.9|13.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 28||13.5|-34.9|0.454
72354308|NCT02365649|144227498|SUPERIORITY||Risk Difference (RD)|-25.0||||0.063|TWO_SIDED|95.0|-44.0|-6.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 28||-6.0|-44.0|0.063
72354309|NCT02365649|144227498|SUPERIORITY||Risk Difference (RD)|10.0||||0.544|TWO_SIDED|95.0|-35.2|55.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 36||55.2|-35.2|0.544
72429215|NCT00598481|144369449|SUPERIORITY||Geometric mean ratio|5.4|||<|0.001|TWO_SIDED|95.0|2.63|11.25||P value related to geometric mean ratio at 2 years post gene therapy compared to baseline|Mixed Model Repeated Measures|||||11.25|2.63|<0.001
72429216|NCT00598481|144369449|SUPERIORITY||Geometric mean ratio|6.5|||<|0.001|TWO_SIDED|95.0|3.08|13.64||P value related to geometric mean ratio at 3 years post gene therapy compared to baseline|Mixed Model Repeated Measures|||||13.64|3.08|<0.001
72354310|NCT02365649|144227498|SUPERIORITY||Risk Difference (RD)|-5.5||||0.663|TWO_SIDED|95.0|-25.5|14.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 36||14.6|-25.5|0.663
72354311|NCT02365649|144227498|SUPERIORITY||Risk Difference (RD)|-15.0||||0.251|TWO_SIDED|95.0|-30.6|0.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 36||0.6|-30.6|0.251
72354312|NCT02365649|144227498|SUPERIORITY||Risk Difference (RD)|-5.0||||1|TWO_SIDED|95.0|-14.6|4.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 44||4.6|-14.6|1.000
72354313|NCT02365649|144227498|SUPERIORITY||Risk Difference (RD)|-0.2||||1|TWO_SIDED|95.0|-13.4|13.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 44||13.0|-13.4|1.000
72354314|NCT02365649|144227498|SUPERIORITY||Risk Difference (RD)|2.1||||1|TWO_SIDED|95.0|-14.4|18.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 44||18.7|-14.4|1.000
72354315|NCT02365649|144227498|SUPERIORITY||Risk Difference (RD)|-10.0||||1|TWO_SIDED|95.0|-23.1|3.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 52||3.1|-23.1|1.000
72354316|NCT02365649|144227498|SUPERIORITY||Risk Difference (RD)|-0.5||||1|TWO_SIDED|95.0|-18.7|17.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 52||17.7|-18.7|1.000
72354317|NCT02365649|144227498|SUPERIORITY||Risk Difference (RD)|-10.0||||0.501|TWO_SIDED|95.0|-23.1|3.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 52||3.1|-23.1|0.501
72354318|NCT02365649|144227499|SUPERIORITY||Risk Difference (RD)|30.0||||0.155|TWO_SIDED|95.0|9.9|50.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 20||50.1|9.9|0.155
72354319|NCT02365649|144227499|SUPERIORITY||Risk Difference (RD)|30.0||||0.024|TWO_SIDED|95.0|9.9|50.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 20||50.1|9.9|0.024
72354320|NCT02365649|144227499|SUPERIORITY||Risk Difference (RD)|-3.3||||1|TWO_SIDED|95.0|-40.1|33.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 20||33.4|-40.1|1.000
72354321|NCT02365649|144227499|SUPERIORITY||Risk Difference (RD)|-8.6||||0.633|TWO_SIDED|95.0|-46.4|29.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 28||29.2|-46.4|0.633
72354322|NCT02365649|144227499|SUPERIORITY||Risk Difference (RD)|1.3||||1|TWO_SIDED|95.0|-24.7|27.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 28||27.2|-24.7|1.000
72354323|NCT02365649|144227499|SUPERIORITY||Risk Difference (RD)|-24.4||||0.209|TWO_SIDED|95.0|-61.3|12.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 28||12.5|-61.3|0.209
72354324|NCT02365649|144227499|SUPERIORITY||Risk Difference (RD)|25.0||||0.283|TWO_SIDED|95.0|6.0|44.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 36||44.0|6.0|0.283
72354325|NCT02365649|144227499|SUPERIORITY||Risk Difference (RD)|0.0||||1|TWO_SIDED|95.0|-28.5|28.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 36||28.5|-28.5|1.000
72354326|NCT02365649|144227499|SUPERIORITY||Risk Difference (RD)|-41.7||||0.048|TWO_SIDED|95.0|-77.8|-5.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 36||-5.5|-77.8|0.048
72354327|NCT02365649|144227499|SUPERIORITY||Risk Difference (RD)|21.4||||0.408|TWO_SIDED|95.0|-18.6|61.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 44||61.4|-18.6|0.408
72354328|NCT02365649|144227499|SUPERIORITY||Risk Difference (RD)|25.0||||0.126|TWO_SIDED|95.0|-5.5|55.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 44||55.5|-5.5|0.126
72354329|NCT02365649|144227499|SUPERIORITY||Risk Difference (RD)|-16.7||||0.454|TWO_SIDED|95.0|-54.5|21.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 44||21.1|-54.5|0.454
72354330|NCT02365649|144227499|SUPERIORITY||Risk Difference (RD)|35.7||||0.183|TWO_SIDED|95.0|1.8|69.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 52||69.7|1.8|0.183
72354331|NCT02365649|144227499|SUPERIORITY||Risk Difference (RD)|18.8||||0.257|TWO_SIDED|95.0|-12.8|50.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 52||50.3|-12.8|0.257
72354332|NCT02365649|144227499|SUPERIORITY||Risk Difference (RD)|-5.6||||1|TWO_SIDED|95.0|-44.7|33.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|ANOVA||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 52||33.6|-44.7|1.000
72354333|NCT02365649|144227499|SUPERIORITY||Risk Difference (RD)|33.3||||0.307|TWO_SIDED|95.0|-9.7|76.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 20||76.3|-9.7|0.307
72354334|NCT02365649|144227499|SUPERIORITY||Risk Difference (RD)|33.3||||0.172|TWO_SIDED|95.0|-4.1|70.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 20||70.8|-4.1|0.172
72354335|NCT02365649|144227499|SUPERIORITY||Risk Difference (RD)|7.1||||1|TWO_SIDED|95.0|-40.9|55.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 20||55.1|-40.9|1.000
72354336|NCT02365649|144227499|SUPERIORITY||Risk Difference (RD)|13.3||||1|TWO_SIDED|95.0|-27.8|54.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 28||54.5|-27.8|1.000
72354337|NCT02365649|144227499|SUPERIORITY||Risk Difference (RD)|-11.7||||0.675|TWO_SIDED|95.0|-51.5|28.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 28||28.1|-51.5|0.675
72354338|NCT02365649|144227499|SUPERIORITY||Risk Difference (RD)|-12.9||||0.644|TWO_SIDED|95.0|-59.2|33.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 28||33.5|-59.2|0.644
72354339|NCT02365649|144227499|SUPERIORITY||Risk Difference (RD)|0.0||||1|TWO_SIDED|95.0|-50.6|50.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 36||50.6|-50.6|1.000
72429217|NCT01994720|144369450|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.89||||0.067|TWO_SIDED|95.0|0.78|1.01||In order to address the issue of multiple testing, a hierarchical test sequence will be used. Tested at 4.98% level.|Regression, Cox|||Composite of stroke/MI/death||1.01|0.78|0.0670
72429218|NCT01994720|144369451|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.87||||0.0462|TWO_SIDED|95.0|0.76|1.0||If the treatment effect on the primary efficacy variable is significant at the 4.98% level, the secondary efficacy variable will be tested in a confirmatory sense. Otherwise it will be tested in an exploratory manner.|Regression, Cox|||Ischemic stroke||1.00|0.76|0.0462
72429219|NCT01994720|144369452|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.9||||0.0928|TWO_SIDED|95.0|0.79|1.02|||Regression, Cox|||||1.02|0.79|0.0928
72429220|NCT01994720|144369453|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.89||||0.0771|TWO_SIDED|95.0|0.78|1.01|||Regression, Cox|||||1.01|0.78|0.0771
72354340|NCT02365649|144227499|SUPERIORITY||Risk Difference (RD)|8.3||||1|TWO_SIDED|95.0|-33.4|50.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 36||50.0|-33.4|1.000
72354341|NCT02365649|144227499|SUPERIORITY||Risk Difference (RD)|7.1||||1|TWO_SIDED|95.0|-40.9|55.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 36||55.1|-40.9|1.000
72354342|NCT02365649|144227499|SUPERIORITY||Risk Difference (RD)|0.0||||1|TWO_SIDED|95.0|-50.6|50.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 44||50.6|-50.6|1.000
72354343|NCT02365649|144227499|SUPERIORITY||Risk Difference (RD)|8.3||||1|TWO_SIDED|95.0|-33.4|50.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 44||50.0|-33.4|1.000
72354344|NCT02365649|144227499|SUPERIORITY||Risk Difference (RD)|7.1||||1|TWO_SIDED|95.0|-40.9|55.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 44||55.1|-40.9|1.000
72354345|NCT02365649|144227499|SUPERIORITY||Risk Difference (RD)|10.0||||1|TWO_SIDED|95.0|-40.2|60.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 52||60.2|-40.2|1.000
72354346|NCT02365649|144227499|SUPERIORITY||Risk Difference (RD)|18.3||||0.392|TWO_SIDED|95.0|-22.9|59.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 52||59.6|-22.9|0.392
72354347|NCT02365649|144227499|SUPERIORITY||Risk Difference (RD)|2.9||||1|TWO_SIDED|95.0|-44.7|50.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 52||50.5|-44.7|1.000
72354348|NCT02365649|144227499|SUPERIORITY||Risk Difference (RD)|29.0||||0.07|TWO_SIDED|95.0|6.5|51.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 20||51.5|6.5|0.070
72354349|NCT02365649|144227499|SUPERIORITY||Risk Difference (RD)|29.5||||0.007|TWO_SIDED|95.0|9.8|49.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 20||49.2|9.8|0.007
72354350|NCT02365649|144227499|SUPERIORITY||Risk Difference (RD)|3.3||||0.826|TWO_SIDED|95.0|-26.1|32.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 20||32.8|-26.1|0.826
72354351|NCT02365649|144227499|SUPERIORITY||Risk Difference (RD)|0.3||||1|TWO_SIDED|95.0|-27.2|27.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 28||27.7|-27.2|1.000
72354352|NCT02365649|144227499|SUPERIORITY||Risk Difference (RD)|-5.2||||0.649|TWO_SIDED|95.0|-27.8|17.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 28||17.3|-27.8|0.649
72354353|NCT02365649|144227499|SUPERIORITY||Risk Difference (RD)|-16.7||||0.304|TWO_SIDED|95.0|-45.7|12.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 28||12.4|-45.7|0.304
72354354|NCT02365649|144227499|SUPERIORITY||Risk Difference (RD)|10.3||||0.72|TWO_SIDED|95.0|-18.2|38.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 36||38.7|-18.2|0.720
72429221|NCT01994720|144369454|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.18||||0.3641|TWO_SIDED|95.0|0.83|1.67|||Regression, Cox|||||1.67|0.83|0.3641
72429222|NCT01994720|144369455|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.18||||0.4828|TWO_SIDED|95.0|0.75|1.85|||Regression, Cox|||||1.85|0.75|0.4828
72429223|NCT01994720|144369456|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.2||||0.5457|TWO_SIDED|95.0|0.67|2.14|||Regression, Cox|||||2.14|0.67|0.5457
72354355|NCT02365649|144227499|SUPERIORITY||Risk Difference (RD)|1.2||||0.923|TWO_SIDED|95.0|-23.0|25.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 36||25.4|-23.0|0.923
72354356|NCT02365649|144227499|SUPERIORITY||Risk Difference (RD)|-20.0||||0.197|TWO_SIDED|95.0|-50.4|10.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 36||10.4|-50.4|0.197
72354357|NCT02365649|144227499|SUPERIORITY||Risk Difference (RD)|11.5||||0.486|TWO_SIDED|95.0|-20.4|43.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 44||43.5|-20.4|0.486
72354358|NCT02365649|144227499|SUPERIORITY||Risk Difference (RD)|17.9||||0.168|TWO_SIDED|95.0|-7.0|42.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 44||42.7|-7.0|0.168
72354359|NCT02365649|144227499|SUPERIORITY||Risk Difference (RD)|-3.3||||0.833|TWO_SIDED|95.0|-34.3|27.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 44||27.6|-34.3|0.833
72354360|NCT02365649|144227499|SUPERIORITY||Risk Difference (RD)|22.6||||0.173|TWO_SIDED|95.0|-8.2|53.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 52||53.4|-8.2|0.173
72354361|NCT02365649|144227499|SUPERIORITY||Risk Difference (RD)|17.6||||0.178|TWO_SIDED|95.0|-7.6|42.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 52||42.8|-7.6|0.178
72354362|NCT02365649|144227499|SUPERIORITY||Risk Difference (RD)|0.0||||1|TWO_SIDED|95.0|-30.9|30.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|ANCOVA||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 52||30.9|-30.9|1.000
72354363|NCT02365649|144227500|SUPERIORITY||Risk Difference (RD)|-27.8||||0.58|TWO_SIDED|95.0|-71.9|16.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 20||16.3|-71.9|0.580
72354364|NCT02365649|144227500|SUPERIORITY||Risk Difference (RD)|-6.9||||1|TWO_SIDED|95.0|-53.6|39.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 20||39.7|-53.6|1.000
72354365|NCT02365649|144227500|SUPERIORITY||Risk Difference (RD)|-24.4||||0.58|TWO_SIDED|95.0|-72.2|23.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 20||23.3|-72.2|0.580
72354366|NCT02365649|144227500|SUPERIORITY||Risk Difference (RD)|-38.9||||0.287|TWO_SIDED|95.0|-83.0|5.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 28||5.2|-83.0|0.287
72354367|NCT02365649|144227500|SUPERIORITY||Risk Difference (RD)|-5.6||||1|TWO_SIDED|95.0|-53.0|41.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 28||41.9|-53.0|1.000
72354368|NCT02365649|144227500|SUPERIORITY||Risk Difference (RD)|-15.6||||1|TWO_SIDED|95.0|-69.4|38.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 28||38.3|-69.4|1.000
72354369|NCT02365649|144227500|SUPERIORITY||Risk Difference (RD)|-27.8||||0.58|TWO_SIDED|95.0|-71.9|16.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 36||16.3|-71.9|0.580
72354370|NCT02365649|144227500|SUPERIORITY||Risk Difference (RD)|5.6||||1|TWO_SIDED|95.0|-41.9|53.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 36||53.0|-41.9|1.000
72354371|NCT02365649|144227500|SUPERIORITY||Risk Difference (RD)|-24.4||||0.58|TWO_SIDED|95.0|-72.2|23.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 36||23.3|-72.2|0.580
72354372|NCT02365649|144227500|SUPERIORITY||Risk Difference (RD)|-44.4||||0.103|TWO_SIDED|95.0|-76.9|-12.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 44||-12.0|-76.9|0.103
72354373|NCT02365649|144227500|SUPERIORITY||Risk Difference (RD)|5.6||||1|TWO_SIDED|95.0|-41.9|53.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 44||53.0|-41.9|1.000
72354374|NCT02365649|144227500|SUPERIORITY||Risk Difference (RD)|-4.4||||1|TWO_SIDED|95.0|-58.3|49.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 44||49.4|-58.3|1.000
72354375|NCT02365649|144227500|SUPERIORITY||Risk Difference (RD)|0.0||||1|TWO_SIDED|95.0|-48.7|48.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 52||48.7|-48.7|1.000
72354376|NCT02365649|144227500|SUPERIORITY||Risk Difference (RD)|16.7||||0.637|TWO_SIDED|95.0|-29.7|63.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 52||63.0|-29.7|0.637
72354377|NCT02365649|144227500|SUPERIORITY||Risk Difference (RD)|-13.3||||1|TWO_SIDED|95.0|-60.0|33.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 52||33.3|-60.0|1.000
72354378|NCT02365649|144227500|SUPERIORITY||Risk Difference (RD)|18.6||||0.57|TWO_SIDED|95.0|-29.4|66.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 20||66.6|-29.4|0.570
72354379|NCT02365649|144227500|SUPERIORITY||Risk Difference (RD)|-14.8||||0.33|TWO_SIDED|95.0|-39.7|10.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 20||10.2|-39.7|0.330
72354380|NCT02365649|144227500|SUPERIORITY||Risk Difference (RD)|-10.3||||1|TWO_SIDED|95.0|-40.0|19.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 20||19.4|-40.0|1.000
72354381|NCT02365649|144227500|SUPERIORITY||Risk Difference (RD)|18.6||||0.57|TWO_SIDED|95.0|-29.4|66.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 28||66.6|-29.4|0.570
72429224|NCT01994720|144369457|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.93||||0.1393|TWO_SIDED|95.0|0.85|1.02|||Regression, Logistic|||||1.02|0.85|0.1393
72354382|NCT02365649|144227500|SUPERIORITY||Risk Difference (RD)|-14.8||||0.33|TWO_SIDED|95.0|-39.7|10.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 28||10.2|-39.7|0.330
72354383|NCT02365649|144227500|SUPERIORITY||Risk Difference (RD)|0.8||||1|TWO_SIDED|95.0|-33.8|35.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 28||35.4|-33.8|1.000
72354384|NCT02365649|144227500|SUPERIORITY||Risk Difference (RD)|-1.4||||1|TWO_SIDED|95.0|-42.6|39.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 36||39.7|-42.6|1.000
72354385|NCT02365649|144227500|SUPERIORITY||Risk Difference (RD)|-21.4||||0.1|TWO_SIDED|95.0|-42.9|0.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 36||0.1|-42.9|0.100
72429225|NCT01994720|144369458|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.86||||0.0342|TWO_SIDED|95.0|0.75|0.99|||Regression, Cox|||||0.99|0.75|0.0342
72429226|NCT01994720|144369459|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.06||||0.8557|TWO_SIDED|95.0|0.55|2.06|||Regression, Cox|||||2.06|0.55|0.8557
72354386|NCT02365649|144227500|SUPERIORITY||Risk Difference (RD)|0.8||||1|TWO_SIDED|95.0|-33.8|35.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 36||35.4|-33.8|1.000
72354387|NCT02365649|144227500|SUPERIORITY||Risk Difference (RD)|5.7||||1|TWO_SIDED|95.0|-33.8|45.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 44||45.3|-33.8|1.000
72354388|NCT02365649|144227500|SUPERIORITY||Risk Difference (RD)|-7.6||||0.598|TWO_SIDED|95.0|-29.9|14.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 44||14.6|-29.9|0.598
72354389|NCT02365649|144227500|SUPERIORITY||Risk Difference (RD)|-3.2||||1|TWO_SIDED|95.0|-30.7|24.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 44||24.3|-30.7|1.000
72354390|NCT02365649|144227500|SUPERIORITY||Risk Difference (RD)|12.9||||0.468|TWO_SIDED|95.0|-24.7|50.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared|||Non-responders, Week 52|Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|50.4|-24.7|0.468
72354391|NCT02365649|144227500|SUPERIORITY||Risk Difference (RD)|6.2||||1|TWO_SIDED|95.0|-15.7|28.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 52||28.1|-15.7|1.000
72354392|NCT02365649|144227500|SUPERIORITY||Risk Difference (RD)|15.1||||0.538|TWO_SIDED|95.0|-15.2|45.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 52||45.4|-15.2|0.538
72354393|NCT02365649|144227500|SUPERIORITY||Risk Difference (RD)|-11.2||||0.692|TWO_SIDED|95.0|-48.0|25.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 20||25.6|-48.0|0.692
72354394|NCT02365649|144227500|SUPERIORITY||Risk Difference (RD)|-14.5||||0.388|TWO_SIDED|95.0|-46.9|17.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 20||17.9|-46.9|0.388
72354395|NCT02365649|144227500|SUPERIORITY||Risk Difference (RD)|-19.0||||0.418|TWO_SIDED|95.0|-54.8|16.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 20||16.9|-54.8|0.418
72354396|NCT02365649|144227500|SUPERIORITY||Risk Difference (RD)|-17.1||||0.448|TWO_SIDED|95.0|-54.1|20.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 28||20.0|-54.1|0.448
72354397|NCT02365649|144227500|SUPERIORITY||Risk Difference (RD)|-13.7||||0.43|TWO_SIDED|95.0|-47.4|19.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 28||19.9|-47.4|0.430
72354398|NCT02365649|144227500|SUPERIORITY||Risk Difference (RD)|-2.6||||1|TWO_SIDED|95.0|-42.8|37.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 28||37.6|-42.8|1.000
72354399|NCT02365649|144227500|SUPERIORITY||Risk Difference (RD)|-21.2||||0.406|TWO_SIDED|95.0|-55.3|12.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 36||12.9|-55.3|0.406
72354400|NCT02365649|144227500|SUPERIORITY||Risk Difference (RD)|-14.5||||0.388|TWO_SIDED|95.0|-46.9|17.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 36||17.9|-46.9|0.388
72429227|NCT01994720|144369460|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.9||||0.2126|TWO_SIDED|95.0|0.77|1.06|||Regression, Cox|||||1.06|0.77|0.2126
72429228|NCT01994720|144369466|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.83||||0.4511|TWO_SIDED|95.0|0.52|1.34|||Regression, Cox|||PLATO Major bleeding||1.34|0.52|0.4511
72429229|NCT01994720|144369467|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.26|||<|0.0001|TWO_SIDED|95.0|1.53|3.34|||Regression, Cox|||||3.34|1.53|<0.0001
72354401|NCT02365649|144227500|SUPERIORITY||Risk Difference (RD)|-7.8||||1|TWO_SIDED|95.0|-46.5|30.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 36||30.8|-46.5|1.000
72354402|NCT02365649|144227500|SUPERIORITY||Risk Difference (RD)|-25.3||||0.204|TWO_SIDED|95.0|-54.7|4.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 44||4.1|-54.7|0.204
72354403|NCT02365649|144227500|SUPERIORITY||Risk Difference (RD)|-2.0||||0.907|TWO_SIDED|95.0|-34.9|31.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 44||31.0|-34.9|0.907
72354404|NCT02365649|144227500|SUPERIORITY||Risk Difference (RD)|-2.0||||1|TWO_SIDED|95.0|-40.2|36.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 44||36.3|-40.2|1.000
72354405|NCT02365649|144227500|SUPERIORITY||Risk Difference (RD)|6.5||||1|TWO_SIDED|95.0|-28.4|41.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 52||41.3|-28.4|1.000
72354406|NCT02365649|144227500|SUPERIORITY||Risk Difference (RD)|16.5||||0.45|TWO_SIDED|95.0|-15.5|48.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 52||48.4|-15.5|0.450
72354407|NCT02365649|144227500|SUPERIORITY||Risk Difference (RD)|9.8||||0.661|TWO_SIDED|95.0|-27.0|46.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 52||46.6|-27.0|0.661
72354408|NCT02365649|144227501|SUPERIORITY||Risk Difference (RD)|0.0||||1|TWO_SIDED|95.0|-77.5|77.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 20||77.5|-77.5|1.000
72354409|NCT02365649|144227501|SUPERIORITY||Risk Difference (RD)|25.0||||0.608|TWO_SIDED|95.0|-20.8|70.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 20||70.8|-20.8|0.608
72354410|NCT02365649|144227501|SUPERIORITY||Risk Difference (RD)|-50.0||||0.105|TWO_SIDED|95.0|-84.6|-15.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 20||-15.4|-84.6|0.105
72354411|NCT02365649|144227501|SUPERIORITY||Risk Difference (RD)|0.0||||1|TWO_SIDED|95.0|-77.5|77.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 28||77.5|-77.5|1.000
72429230|NCT01991197|144369468|SUPERIORITY||U value|43.5||||0.648|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.648
72429231|NCT01991197|144369471|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1
72429232|NCT01991197|144369474|SUPERIORITY||U|29.5||||0.128|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.128
72429233|NCT02216422|144369484|SUPERIORITY_OR_OTHER||Percentage of Participants|100.0|||||TWO_SIDED|95.0|90.4|100.0|||||95% confidence interval (CI) was calculated using Wilson score method.|||100.0|90.4|
72429234|NCT02397460|144369489|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||Treatment effects on Emax following capsaicin challenge were modeled for dose dependence and were estimated on the basis of disease status for participants who were healthy or had chronic cough and received gefapixant 50 mg, gefapixant 300 mg, or placebo.||||< 0.0001
72354412|NCT02365649|144227501|SUPERIORITY||Risk Difference (RD)|0.0||||1|TWO_SIDED|95.0|-49.0|49.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 28||49.0|-49.0|1.000
72354413|NCT02365649|144227501|SUPERIORITY||Risk Difference (RD)|-30.0||||0.565|TWO_SIDED|95.0|-79.3|19.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|ANOVA||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 28||19.3|-79.3|0.565
72429235|NCT02397460|144369490|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||Treatment effects following capsaicin challenge were modeled for dose. dependence and were estimated on the basis of disease status for participants who had chronic cough and received gefapixant 50 mg, gefapixant 300 mg, or placebo.||||< 0.0001
72354414|NCT02365649|144227501|SUPERIORITY||Risk Difference (RD)|50.0||||0.467|TWO_SIDED|95.0|15.4|84.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 36||84.6|15.4|0.467
72354415|NCT02365649|144227501|SUPERIORITY||Risk Difference (RD)|0.0||||1|TWO_SIDED|95.0|-49.0|49.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 36||49.0|-49.0|1.000
72354416|NCT02365649|144227501|SUPERIORITY||Risk Difference (RD)|-50.0||||0.105|TWO_SIDED|95.0|-84.6|-15.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 36||-15.4|-84.6|0.105
72354417|NCT02365649|144227501|SUPERIORITY||Risk Difference (RD)|12.5||||1|TWO_SIDED|95.0|-64.5|89.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 44||89.5|-64.5|1.000
72354418|NCT02365649|144227501|SUPERIORITY||Risk Difference (RD)|12.5||||1|TWO_SIDED|95.0|-35.7|60.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 44||60.7|-35.7|1.000
72354419|NCT02365649|144227501|SUPERIORITY||Risk Difference (RD)|-17.5||||1|TWO_SIDED|95.0|-66.0|31.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 44||31.0|-66.0|1.000
72354420|NCT02365649|144227501|SUPERIORITY||Risk Difference (RD)|50.0||||0.467|TWO_SIDED|95.0|15.4|84.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 52||84.6|15.4|0.467
72354421|NCT02365649|144227501|SUPERIORITY||Risk Difference (RD)|12.5||||1|TWO_SIDED|95.0|-35.7|60.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 52||60.7|-35.7|1.000
72354422|NCT02365649|144227501|SUPERIORITY||Risk Difference (RD)|-50.0||||0.105|TWO_SIDED|95.0|-84.6|-15.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 52||-15.4|-84.6|0.105
72354423|NCT02365649|144227501|SUPERIORITY||Risk Difference (RD)|26.7||||0.249|TWO_SIDED|95.0|-19.6|72.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 20||72.9|-19.6|0.249
72354424|NCT02365649|144227501|SUPERIORITY||Risk Difference (RD)|-5.0||||1|TWO_SIDED|95.0|-28.2|18.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 20||18.2|-28.2|1.000
72354425|NCT02365649|144227501|SUPERIORITY||Risk Difference (RD)|-13.3||||0.511|TWO_SIDED|95.0|-30.5|3.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 20||3.9|-30.5|0.511
72354426|NCT02365649|144227501|SUPERIORITY||Risk Difference (RD)|33.3||||0.14|TWO_SIDED|95.0|-11.4|78.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 28||78.1|-11.4|0.140
72354427|NCT02365649|144227501|SUPERIORITY||Risk Difference (RD)|10.0||||0.569|TWO_SIDED|95.0|-14.6|34.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 28||34.6|-14.6|0.569
72354428|NCT02365649|144227501|SUPERIORITY||Risk Difference (RD)|4.4||||1|TWO_SIDED|95.0|-19.7|28.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 28||28.5|-19.7|1.000
72354429|NCT02365649|144227501|SUPERIORITY||Risk Difference (RD)|26.7||||0.249|TWO_SIDED|95.0|-19.6|72.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 36||72.9|-19.6|0.249
72354430|NCT02365649|144227501|SUPERIORITY||Risk Difference (RD)|-5.0||||1|TWO_SIDED|95.0|-28.2|18.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 36||18.2|-28.2|1.000
72354431|NCT02365649|144227501|SUPERIORITY||Risk Difference (RD)|-2.2||||1|TWO_SIDED|95.0|-29.0|24.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 36||24.6|-29.0|1.000
72354432|NCT02365649|144227501|SUPERIORITY||Risk Difference (RD)|13.3||||0.613|TWO_SIDED|95.0|-35.1|61.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 44||61.8|-35.1|0.613
72354433|NCT02365649|144227501|SUPERIORITY||Risk Difference (RD)|-1.7||||1|TWO_SIDED|95.0|-34.8|31.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 44||31.5|-34.8|1.000
72354434|NCT02365649|144227501|SUPERIORITY||Risk Difference (RD)|-15.6||||0.615|TWO_SIDED|95.0|-45.9|14.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 44||14.8|-45.9|0.615
72354435|NCT02365649|144227501|SUPERIORITY||Risk Difference (RD)|20.0||||0.56|TWO_SIDED|95.0|-27.5|67.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 52||67.5|-27.5|0.560
72354436|NCT02365649|144227501|SUPERIORITY||Risk Difference (RD)|5.0||||1|TWO_SIDED|95.0|-26.8|36.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared|||Non-responders, Week 52||36.8|-26.8|1.000
72354437|NCT02365649|144227501|SUPERIORITY||Risk Difference (RD)|-8.9||||1|TWO_SIDED|95.0|-37.7|19.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 52||19.9|-37.7|1.000
72354438|NCT02365649|144227501|SUPERIORITY||Risk Difference (RD)|10.0||||1|TWO_SIDED|95.0|-37.1|57.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 20||57.1|-37.1|1.000
72354439|NCT02365649|144227501|SUPERIORITY||Risk Difference (RD)|10.0||||0.588|TWO_SIDED|95.0|-26.1|46.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 20||46.1|-26.1|0.588
72354440|NCT02365649|144227501|SUPERIORITY||Risk Difference (RD)|-40.0||||0.058|TWO_SIDED|95.0|-64.8|-15.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5). Prespecified statistical significance at the 0.1 level.|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 20||-15.2|-64.8|0.058
72354441|NCT02365649|144227501|SUPERIORITY||Risk Difference (RD)|16.7||||0.631|TWO_SIDED|95.0|-29.9|63.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 28||63.2|-29.9|0.631
72354442|NCT02365649|144227501|SUPERIORITY||Risk Difference (RD)|9.5||||0.597|TWO_SIDED|95.0|-25.7|44.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 28||44.8|-25.7|0.597
72354443|NCT02365649|144227501|SUPERIORITY||Risk Difference (RD)|-8.3||||1|TWO_SIDED|95.0|-46.7|30.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 28||30.0|-46.7|1.000
72354444|NCT02365649|144227501|SUPERIORITY||Risk Difference (RD)|26.7||||0.361|TWO_SIDED|95.0|-18.5|71.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 36||71.8|-18.5|0.361
72354445|NCT02365649|144227501|SUPERIORITY||Risk Difference (RD)|-4.3||||0.812|TWO_SIDED|95.0|-39.6|31.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 36||31.0|-39.6|0.812
72354446|NCT02365649|144227501|SUPERIORITY||Risk Difference (RD)|-27.5||||0.345|TWO_SIDED|95.0|-61.3|6.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 36||6.3|-61.3|0.345
72354447|NCT02365649|144227501|SUPERIORITY||Risk Difference (RD)|10.0||||1|TWO_SIDED|95.0|-37.1|57.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 44||57.1|-37.1|1.000
72354448|NCT02365649|144227501|SUPERIORITY||Risk Difference (RD)|10.0||||0.588|TWO_SIDED|95.0|-26.1|46.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 44||46.1|-26.1|0.588
72354449|NCT02365649|144227501|SUPERIORITY||Risk Difference (RD)|-15.0||||0.657|TWO_SIDED|95.0|-53.9|23.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 44||23.9|-53.9|0.657
72354450|NCT02365649|144227501|SUPERIORITY||Risk Difference (RD)|20.0||||0.635|TWO_SIDED|95.0|-25.4|65.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 52||65.4|-25.4|0.635
72354451|NCT02365649|144227501|SUPERIORITY||Risk Difference (RD)|10.5||||0.573|TWO_SIDED|95.0|-25.7|46.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 52||46.7|-25.7|0.573
72354452|NCT02365649|144227501|SUPERIORITY||Risk Difference (RD)|-34.2||||0.176|TWO_SIDED|95.0|-68.3|-0.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 52||-0.1|-68.3|0.176
72354453|NCT02365649|144227501|SUPERIORITY||Risk Difference (RD)|-12.5||||1|TWO_SIDED|95.0|-35.4|10.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 44||10.4|-35.4|1.000
72354454|NCT02365649|144227501|SUPERIORITY||Risk Difference (RD)|-12.5||||1|TWO_SIDED|95.0|-35.4|10.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 44||10.4|-35.4|1.000
72354455|NCT02365649|144227501|SUPERIORITY||Risk Difference (RD)|-12.5||||1|TWO_SIDED|95.0|-35.4|10.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 44||10.4|-35.4|1.000
72354456|NCT02365649|144227502|SUPERIORITY||Risk Difference (RD)|-25.0||||1|TWO_SIDED|95.0|-55.0|5.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders||5.0|-55.0|1.000
72354457|NCT02365649|144227502|SUPERIORITY||Risk Difference (RD)|12.5||||1|TWO_SIDED|95.0|-32.5|57.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders||57.5|-32.5|1.000
72354458|NCT02365649|144227502|SUPERIORITY||Risk Difference (RD)|-25.0||||0.487|TWO_SIDED|95.0|-55.0|5.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders||5.0|-55.0|0.487
72354459|NCT02365649|144227502|SUPERIORITY||Risk Difference (RD)|11.1||||0.375|TWO_SIDED|95.0|-9.4|31.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ|Non-respoonders||31.6|-9.4|0.375
72354460|NCT02365649|144227502|SUPERIORITY||Risk Difference (RD)|-13.3||||1|TWO_SIDED|95.0|-30.5|3.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders||3.9|-30.5|1.000
72429236|NCT01168674|144369505|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.57|STANDARD_DEVIATION|1.67||0.48|TWO_SIDED||||||Mixed Models Analysis||The report is of the mean MADRS difference between ziprasidone versus placebo after linear mixed regression, correcting for confounding effects of order of treatment as well as other identified potential confounders.|Linear mixed effects regression model||||0.48
72354461|NCT02365649|144227502|SUPERIORITY||Risk Difference (RD)|8.1||||0.651|TWO_SIDED|95.0|-19.4|35.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders||35.6|-19.4|0.651
72354462|NCT02365649|144227502|SUPERIORITY||Risk Difference (RD)|-0.8||||1|TWO_SIDED|95.0|-29.5|27.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders||27.8|-29.5|1.000
72354463|NCT02365649|144227503|SUPERIORITY||Risk Difference (RD)|0.0||||1|TWO_SIDED|95.0|-77.5|77.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 20||77.5|-77.5|1.000
72354464|NCT02365649|144227503|SUPERIORITY||Risk Difference (RD)|0.0||||1|TWO_SIDED|95.0|-49.0|49.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 20||49.0|-49.0|1.000
72354465|NCT02365649|144227503|SUPERIORITY||Risk Difference (RD)|-50.0||||0.105|TWO_SIDED|95.0|-84.6|-15.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 20||-15.4|-84.6|0.105
72354466|NCT02365649|144227503|SUPERIORITY||Risk Difference (RD)|12.5||||1|TWO_SIDED|95.0|-64.5|89.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 28||89.5|-64.5|1.000
72354467|NCT02365649|144227503|SUPERIORITY||Risk Difference (RD)|12.5||||1|TWO_SIDED|95.0|-35.7|60.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 28||60.7|-35.7|1.000
72354468|NCT02365649|144227503|SUPERIORITY||Risk Difference (RD)|-17.5||||1|TWO_SIDED|95.0|-66.0|31.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 28||31.0|-66.0|1.000
72354469|NCT02365649|144227503|SUPERIORITY||Risk Difference (RD)|62.5||||0.444|TWO_SIDED|95.0|29.0|96.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 36||96.0|29.0|0.444
72354470|NCT02365649|144227503|SUPERIORITY||Risk Difference (RD)|25.0||||0.619|TWO_SIDED|95.0|-22.4|72.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 36||72.4|-22.4|0.619
72354471|NCT02365649|144227503|SUPERIORITY||Risk Difference (RD)|-37.5||||0.231|TWO_SIDED|95.0|-71.0|-4.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 36||-4.0|-71.0|0.231
72354472|NCT02365649|144227503|SUPERIORITY||Risk Difference (RD)|-37.5||||1|TWO_SIDED|95.0|-71.0|-4.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 44||-4.0|-71.0|1.000
72354473|NCT02365649|144227503|SUPERIORITY||Risk Difference (RD)|25.0||||0.619|TWO_SIDED|95.0|-22.4|72.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 44||72.4|-22.4|0.619
72354474|NCT02365649|144227503|SUPERIORITY||Risk Difference (RD)|-17.5||||1|TWO_SIDED|95.0|-66.0|31.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 44||31.0|-66.0|1.000
72354475|NCT02365649|144227503|SUPERIORITY||Risk Difference (RD)|75.0||||0.133|TWO_SIDED|95.0|45.0|100.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 52||100.0|45.0|0.133
72354476|NCT02365649|144227503|SUPERIORITY||Risk Difference (RD)|37.5||||0.315|TWO_SIDED|95.0|-7.5|82.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 52||82.5|-7.5|0.315
72354477|NCT02365649|144227503|SUPERIORITY||Risk Difference (RD)|-25.0||||0.487|TWO_SIDED|95.0|-55.0|5.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 52||5.0|-55.0|0.487
72354478|NCT02365649|144227503|SUPERIORITY||Risk Difference (RD)|26.7||||0.249|TWO_SIDED|95.0|-19.6|72.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 20||72.9|-19.6|0.249
72354479|NCT02365649|144227503|SUPERIORITY||Risk Difference (RD)|-13.3||||0.487|TWO_SIDED|95.0|-30.5|3.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 20||3.9|-30.5|0.487
72354480|NCT02365649|144227503|SUPERIORITY||Risk Difference (RD)|-13.3||||0.511|TWO_SIDED|95.0|-30.5|3.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 20||3.9|-30.5|0.511
72354481|NCT02365649|144227503|SUPERIORITY||Risk Difference (RD)|33.3||||0.14|TWO_SIDED|95.0|-11.4|78.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 28||78.1|-11.4|0.140
72354482|NCT02365649|144227503|SUPERIORITY||Risk Difference (RD)|10.0||||0.569|TWO_SIDED|95.0|-14.6|34.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 28||34.6|-14.6|0.569
72354483|NCT02365649|144227503|SUPERIORITY||Risk Difference (RD)|4.4||||1|TWO_SIDED|95.0|-19.7|28.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 28||28.5|-19.7|1.000
72354484|NCT02365649|144227503|SUPERIORITY||Risk Difference (RD)|13.3||||0.447|TWO_SIDED|95.0|-23.9|50.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 36||50.6|-23.9|0.447
72354485|NCT02365649|144227503|SUPERIORITY||Risk Difference (RD)|-6.7||||1|TWO_SIDED|95.0|-19.3|6.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 36||6.0|-19.3|1.000
72354486|NCT02365649|144227503|SUPERIORITY||Risk Difference (RD)|4.4||||1|TWO_SIDED|95.0|-19.7|28.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 36||28.5|-19.7|1.000
72354487|NCT02365649|144227503|SUPERIORITY||Risk Difference (RD)|20.0||||0.56|TWO_SIDED|95.0|-27.5|67.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 44||67.5|-27.5|0.560
72429237|NCT04793464|144369524|SUPERIORITY||Mean Difference (Final Values)|0.77||||0.26|TWO_SIDED||||||ANCOVA|||Number analyzed is the number of participants with valid baseline and follow-up data.||||.26
72354488|NCT02365649|144227503|SUPERIORITY||Risk Difference (RD)|-20.0||||0.231|TWO_SIDED|95.0|-40.2|0.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 44||0.2|-40.2|0.231
72354489|NCT02365649|144227503|SUPERIORITY||Risk Difference (RD)|-8.9||||1|TWO_SIDED|95.0|-37.7|19.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 44||19.9|-37.7|1.000
72354490|NCT02365649|144227503|SUPERIORITY||Risk Difference (RD)|6.7||||1|TWO_SIDED|95.0|-32.4|45.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 52||45.7|-32.4|1.000
72429238|NCT04793464|144369525|SUPERIORITY||Mean Difference (Final Values)|0.87||||0.02|TWO_SIDED||||||ANCOVA|Ratio of Means||Number analyzed is the number of participants with valid baseline and follow-up data.||||.02
72429239|NCT04793464|144369526|SUPERIORITY||Odds Ratio (OR)|1.1||||0.68|TWO_SIDED||||||ANCOVA|Logistic regression||Number analyzed is the number of participants with valid baseline and follow-up data.||||.68
72429240|NCT04793464|144369527|SUPERIORITY||Odds Ratio (OR)|1.19||||0.44|TWO_SIDED||||||ANCOVA|Logistic regression||Number analyzed is the number of participants with valid baseline and follow-up data.||||.44
72429241|NCT04793464|144369528|SUPERIORITY||Mean Difference (Final Values)|0.015||||0.77|TWO_SIDED||||||ANCOVA|||Number analyzed is the number of participants with valid baseline and follow-up data.||||.77
72354491|NCT02365649|144227503|SUPERIORITY||Risk Difference (RD)|-5.0||||1|TWO_SIDED|95.0|-28.2|18.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 52||18.2|-28.2|1.000
72354492|NCT02365649|144227503|SUPERIORITY||Risk Difference (RD)|-2.2||||1|TWO_SIDED|95.0|-29.0|24.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 52||24.6|-29.0|1.000
72354493|NCT02365649|144227503|SUPERIORITY||Risk Difference (RD)|10.0||||1|TWO_SIDED|95.0|-37.1|57.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 20||57.1|-37.1|1.000
72354494|NCT02365649|144227503|SUPERIORITY||Risk Difference (RD)|-11.4||||0.7|TWO_SIDED|95.0|-45.7|22.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 20||22.8|-45.7|0.700
72354495|NCT02365649|144227503|SUPERIORITY||Risk Difference (RD)|-40.0||||0.058|TWO_SIDED|95.0|-64.8|-15.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5). Prespecified statistical significance at the 0.1 level.|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 20||-15.2|-64.8|0.058
72354496|NCT02365649|144227503|SUPERIORITY||Risk Difference (RD)|23.3||||0.354|TWO_SIDED|95.0|-22.5|69.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 28||69.2|-22.5|0.354
72354497|NCT02365649|144227503|SUPERIORITY||Risk Difference (RD)|16.2||||0.45|TWO_SIDED|95.0|-18.1|50.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 28||50.4|-18.1|0.450
72354498|NCT02365649|144227503|SUPERIORITY||Risk Difference (RD)|-1.7||||1|TWO_SIDED|95.0|-39.1|35.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 28||35.8|-39.1|1.000
72354499|NCT02365649|144227503|SUPERIORITY||Risk Difference (RD)|23.3||||0.354|TWO_SIDED|95.0|-22.5|69.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 36||69.2|-22.5|0.354
72354500|NCT02365649|144227503|SUPERIORITY||Risk Difference (RD)|9.0||||0.7|TWO_SIDED|95.0|-24.6|42.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 36||42.7|-24.6|0.700
72354501|NCT02365649|144227503|SUPERIORITY||Risk Difference (RD)|-14.2||||0.621|TWO_SIDED|95.0|-46.2|17.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 36||17.9|-46.2|0.621
72354502|NCT02365649|144227503|SUPERIORITY||Risk Difference (RD)|-6.7||||1|TWO_SIDED|95.0|-51.8|38.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 44||38.5|-51.8|1.000
72354503|NCT02365649|144227503|SUPERIORITY||Risk Difference (RD)|-4.3||||0.812|TWO_SIDED|95.0|-39.6|31.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 44||31.0|-39.6|0.812
72354504|NCT02365649|144227503|SUPERIORITY||Risk Difference (RD)|-15.0||||0.657|TWO_SIDED|95.0|-53.9|23.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 44||23.9|-53.9|0.657
72354505|NCT02365649|144227503|SUPERIORITY||Risk Difference (RD)|23.3||||0.354|TWO_SIDED|95.0|-22.5|69.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 52||69.2|-22.5|0.354
72429242|NCT04793464|144369529|SUPERIORITY||Mean Difference (Final Values)|0.017||||0.66|TWO_SIDED||||||ANCOVA|||Number analyzed is the number of participants with valid baseline and follow-up data.||||.66
72429243|NCT04793464|144369530|SUPERIORITY||Mean Difference (Final Values)|-0.05||||0.44|TWO_SIDED||||||ANCOVA|||Number analyzed is the number of participants with valid baseline and follow-up data.||||.44
72354506|NCT02365649|144227503|SUPERIORITY||Risk Difference (RD)|16.2||||0.45|TWO_SIDED|95.0|-18.1|50.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 52||50.4|-18.1|0.450
72354507|NCT02365649|144227503|SUPERIORITY||Risk Difference (RD)|-14.2||||0.621|TWO_SIDED|95.0|-46.2|17.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 52||17.9|-46.2|0.621
72354508|NCT02365649|144227504|SUPERIORITY||Risk Difference (RD)|16.7||||1|TWO_SIDED|95.0|-62.2|95.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20%of the cells have expected cell count \<5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Responders, Week 20||95.6|-62.2|1.000
72354509|NCT02365649|144227504|SUPERIORITY||Risk Difference (RD)|29.2||||0.592|TWO_SIDED|95.0|-21.3|79.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Responders, Week 20||79.6|-21.3|0.592
72354510|NCT02365649|144227504|SUPERIORITY||Risk Difference (RD)|-13.3||||1|TWO_SIDED|95.0|-64.8|38.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Responders, Week 20||38.2|-64.8|1.000
72354511|NCT02365649|144227504|SUPERIORITY||Risk Difference (RD)|0.0||||1|TWO_SIDED|95.0|-80.0|80.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Responders, Week 28||80.0|-80.0|1.000
72354512|NCT02365649|144227504|SUPERIORITY||Risk Difference (RD)|12.5||||1|TWO_SIDED|95.0|-39.7|64.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Responders, Week 28||64.7|-39.7|1.000
72354513|NCT02365649|144227504|SUPERIORITY||Risk Difference (RD)|-30.0||||0.545|TWO_SIDED|95.0|-83.2|23.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Responders, Week 28||23.2|-83.2|0.545
72354514|NCT02365649|144227504|SUPERIORITY||Risk Difference (RD)|50.0||||0.464|TWO_SIDED|95.0|10.0|90.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Responders, Week 36||90.0|10.0|0.464
72354515|NCT02365649|144227504|SUPERIORITY||Risk Difference (RD)|12.5||||1|TWO_SIDED|95.0|-39.7|64.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Responders, Week 36||64.7|-39.7|1.000
72354516|NCT02365649|144227504|SUPERIORITY||Risk Difference (RD)|-50.0||||0.182|TWO_SIDED|95.0|-90.0|-10.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Responders, Week 36||-10.0|-90.0|0.182
72354517|NCT02365649|144227504|SUPERIORITY||Risk Difference (RD)|16.7||||1|TWO_SIDED|95.0|-62.2|95.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Responders, Week 44||95.6|-62.2|1.000
72354518|NCT02365649|144227504|SUPERIORITY||Risk Difference (RD)|29.2||||0.592|TWO_SIDED|95.0|-21.3|79.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Responders, Week 44||79.6|-21.3|0.592
72354519|NCT02365649|144227504|SUPERIORITY||Risk Difference (RD)|-13.3||||1|TWO_SIDED|95.0|-64.8|38.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Responders, Week 44||38.2|-64.8|1.000
72429244|NCT04793464|144369531|SUPERIORITY||Mean Difference (Final Values)|-0.12||||0.017|TWO_SIDED||||||ANCOVA|||Number analyzed is the number of participants with valid baseline and follow-up data.||||0.017
72429245|NCT03615482|144369535|OTHER|Difference in Percent vs. Non-concomitant Group|Difference in Percent|-0.9||||0.617|TWO_SIDED|95.0|-4.5|2.7|||Miettinen & Nurminen|Estimated differences, confidence intervals (CIs), and p-values were calculated based on Miettinen \& Nurminen method.||Injection-Site Erythema||2.7|-4.5|0.617
72354520|NCT02365649|144227504|SUPERIORITY||Risk Difference (RD)|66.7||||0.429|TWO_SIDED|95.0|28.9|100.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Responders, Week 52||100.0|28.9|0.429
72354521|NCT02365649|144227504|SUPERIORITY||Risk Difference (RD)|29.2||||0.592|TWO_SIDED|95.0|-21.3|79.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Responders, Week 52||79.6|-21.3|0.592
72354522|NCT02365649|144227504|SUPERIORITY||Risk Difference (RD)|-33.3||||0.455|TWO_SIDED|95.0|-71.1|4.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Responders, Week 52||4.4|-71.1|0.455
72354523|NCT02365649|144227504|SUPERIORITY||Risk Difference (RD)|31.7||||0.191|TWO_SIDED|95.0|-14.0|77.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Non-responders, Week 20||77.4|-14.0|0.191
72354524|NCT02365649|144227504|SUPERIORITY||Risk Difference (RD)|0.0||||1|TWO_SIDED|95.0|-22.1|22.1|||Chi-squared|P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Non-responders, Week 20||22.1|-22.1|1.000
72354525|NCT02365649|144227504|SUPERIORITY||Risk Difference (RD)|-8.3||||1|TWO_SIDED|95.0|-24.0|7.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Non-responders, Week 20||7.3|-24.0|1.000
72354526|NCT02365649|144227504|SUPERIORITY||Risk Difference (RD)|23.3||||0.538|TWO_SIDED|95.0|-24.5|71.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Non-responders, Week 28||71.2|-24.5|0.538
72354527|NCT02365649|144227504|SUPERIORITY||Risk Difference (RD)|0.0||||1|TWO_SIDED|95.0|-29.8|29.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Non-responders, Week 28||29.8|-29.8|1.000
72354528|NCT02365649|144227504|SUPERIORITY||Risk Difference (RD)|-4.2||||1|TWO_SIDED|95.0|-35.3|27.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Non-responders, Week 28||27.0|-35.3|1.000
72354529|NCT02365649|144227504|SUPERIORITY||Risk Difference (RD)|11.7||||0.515|TWO_SIDED|95.0|-26.7|50.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Non-responders, Week 36||50.1|-26.7|0.515
72354530|NCT02365649|144227504|SUPERIORITY||Risk Difference (RD)|0.0||||1|TWO_SIDED|95.0|-22.1|22.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Non-responders, Week 36||22.1|-22.1|1.000
72354531|NCT02365649|144227504|SUPERIORITY||Risk Difference (RD)|4.2||||1|TWO_SIDED|95.0|-23.6|31.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Non-responders, Week 36||31.9|-23.6|1.000
72354532|NCT02365649|144227504|SUPERIORITY||Risk Difference (RD)|23.3||||0.538|TWO_SIDED|95.0|-24.5|71.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Non-responders, Week 44||71.2|-24.5|0.538
72354533|NCT02365649|144227504|SUPERIORITY||Risk Difference (RD)|-16.7||||0.478|TWO_SIDED|95.0|-37.8|4.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Non-responders, Week 44||4.4|-37.8|0.478
72354534|NCT02365649|144227504|SUPERIORITY||Risk Difference (RD)|-4.2||||1|TWO_SIDED|95.0|-35.3|27.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Non-responders, Week 44||27.0|-35.3|1.000
72354535|NCT02365649|144227504|SUPERIORITY||Risk Difference (RD)|11.7||||0.515|TWO_SIDED|95.0|-26.7|50.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Non-responders, Week 52||50.1|-26.7|0.515
72354536|NCT02365649|144227504|SUPERIORITY||Risk Difference (RD)|8.3||||1|TWO_SIDED|95.0|-17.9|34.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Non-responders, Week 52||34.6|-17.9|1.000
72354537|NCT02365649|144227504|SUPERIORITY||Risk Difference (RD)|4.2||||1|TWO_SIDED|95.0|-23.6|31.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Non-responders, Week 52||31.9|-23.6|1.000
72354538|NCT02365649|144227504|SUPERIORITY||Risk Difference (RD)|25.0||||0.344|TWO_SIDED|95.0|-21.9|71.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical Responders, Week 20||71.9|-21.9|0.344
72354539|NCT02365649|144227504|SUPERIORITY||Risk Difference (RD)|17.9||||0.429|TWO_SIDED|95.0|-17.8|53.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical Responders, Week 20||53.5|-17.8|0.429
72354540|NCT02365649|144227504|SUPERIORITY||Risk Difference (RD)|-10.7||||1|TWO_SIDED|95.0|-46.4|25.0|||Chi-squared|P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical Responders, Week 20||25.0|-46.4|1.000
72354541|NCT02365649|144227504|SUPERIORITY||Risk Difference (RD)|8.3||||1|TWO_SIDED|95.0|-40.4|57.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical Responders, Week 28||57.1|-40.4|1.000
72354542|NCT02365649|144227504|SUPERIORITY||Risk Difference (RD)|8.3||||0.671|TWO_SIDED|95.0|-29.9|46.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical Responders, Week 28||46.6|-29.9|0.671
72354543|NCT02365649|144227504|SUPERIORITY||Risk Difference (RD)|-13.1||||0.656|TWO_SIDED|95.0|-56.7|30.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical Responders, Week 28||30.5|-56.7|0.656
72354544|NCT02365649|144227504|SUPERIORITY||Risk Difference (RD)|16.7||||0.627|TWO_SIDED|95.0|-31.4|64.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical Responders, Week 36||64.7|-31.4|0.627
72354545|NCT02365649|144227504|SUPERIORITY||Risk Difference (RD)|9.5||||0.701|TWO_SIDED|95.0|-27.7|46.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical Responders, Week 36||46.7|-27.7|0.701
72354546|NCT02365649|144227504|SUPERIORITY||Risk Difference (RD)|-19.0||||0.603|TWO_SIDED|95.0|-56.2|18.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical Responders, Week 36||18.1|-56.2|0.603
72354547|NCT02365649|144227504|SUPERIORITY||Risk Difference (RD)|16.7||||0.627|TWO_SIDED|95.0|-31.4|64.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical Responders, Week 44||64.7|-31.4|0.627
72354548|NCT02365649|144227504|SUPERIORITY||Risk Difference (RD)|2.4||||1|TWO_SIDED|95.0|-34.2|39.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical Responders, Week 44||39.0|-34.2|1.000
72354549|NCT02365649|144227504|SUPERIORITY||Risk Difference (RD)|-4.8||||1|TWO_SIDED|95.0|-47.6|38.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical Responders, Week 44||38.0|-47.6|1.000
72354550|NCT02365649|144227504|SUPERIORITY||Risk Difference (RD)|25.0||||0.344|TWO_SIDED|95.0|-21.9|71.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical Responders, Week 52||71.9|-21.9|0.344
72354551|NCT02365649|144227504|SUPERIORITY||Risk Difference (RD)|25.0||||0.248|TWO_SIDED|95.0|-10.9|60.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical Responders, Week 52||60.9|-10.9|0.248
72429246|NCT03615482|144369535|OTHER|Difference in Percent vs. Non-concomitant Group|Difference in Percent|-2.6||||0.32|TWO_SIDED|95.0|-7.8|2.6|||Miettinen & Nurminen|Estimated differences, confidence intervals (CIs), and p-values were calculated based on Miettinen \& Nurminen method.||Injection-Site Pain||2.6|-7.8|0.320
72354552|NCT02365649|144227504|SUPERIORITY||Risk Difference (RD)|-10.7||||1|TWO_SIDED|95.0|-46.4|25.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical Responders, Week 52||25.0|-46.4|1.000
72354553|NCT02365649|144227505|SUPERIORITY||Risk Difference (RD)|-25.0||||1|TWO_SIDED|95.0|-55.0|5.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Responders||5.0|-55.0|1.000
72354554|NCT02365649|144227505|SUPERIORITY||Risk Difference (RD)|25.0||||0.608|TWO_SIDED|95.0|-20.8|70.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Responders||70.8|-20.8|0.608
72354555|NCT02365649|144227505|SUPERIORITY||Risk Difference (RD)|-25.0||||0.487|TWO_SIDED|95.0|-55.0|5.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Responders||5.0|-55.0|0.487
72354556|NCT02365649|144227505|SUPERIORITY||Risk Difference (RD)|20.0||||0.25|TWO_SIDED|95.0|-15.1|55.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Non-responders||55.1|-15.1|0.250
72354557|NCT02365649|144227505|SUPERIORITY||Risk Difference (RD)|8.3||||0.444|TWO_SIDED|95.0|-7.3|24.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Non-responders||24.0|-7.3|0.444
72354558|NCT02365649|144227505|SUPERIORITY||Risk Difference (RD)|11.1||||0.375|TWO_SIDED|95.0|-9.4|31.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Non-responders||31.6|-9.4|0.375
72354559|NCT02365649|144227505|SUPERIORITY||Risk Difference (RD)|3.3||||1|TWO_SIDED|95.0|-31.1|37.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical responders||37.8|-31.1|1.000
72354560|NCT02365649|144227505|SUPERIORITY||Risk Difference (RD)|22.4||||0.215|TWO_SIDED|95.0|-8.0|52.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical responders||52.8|-8.0|0.215
72354561|NCT02365649|144227505|SUPERIORITY||Risk Difference (RD)|-0.8||||1|TWO_SIDED|95.0|-29.5|27.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical responders||27.8|-29.5|1.000
72354562|NCT02365649|144227506|SUPERIORITY||Risk Difference (RD)|-15.0||||0.671|TWO_SIDED|95.0|-55.5|25.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Responders, Week 20||25.5|-55.5|0.671
72354563|NCT02365649|144227506|SUPERIORITY||Risk Difference (RD)|10.0||||0.718|TWO_SIDED|95.0|-19.8|39.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Responders, Week 20||39.8|-19.8|0.718
72354564|NCT02365649|144227506|SUPERIORITY||Risk Difference (RD)|-15.0||||0.461|TWO_SIDED|95.0|-52.4|22.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Responders, Week 20||22.4|-52.4|0.461
72354565|NCT02365649|144227506|SUPERIORITY||Risk Difference (RD)|-50.0||||0.03|TWO_SIDED|95.0|-85.5|-14.5||Statistically significant at 0.05 level. P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Responders, Week 28||-14.5|-85.5|0.030
72354566|NCT02365649|144227506|SUPERIORITY||Risk Difference (RD)|-12.5||||0.483|TWO_SIDED|95.0|-42.9|17.9|||Chi-squared|P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Responders, Week 28||17.9|-42.9|0.483
72354567|NCT02365649|144227506|SUPERIORITY||Risk Difference (RD)|-15.0||||0.431|TWO_SIDED|95.0|-50.8|20.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Responders, Week 28||20.8|-50.8|0.431
72354568|NCT02365649|144227506|SUPERIORITY||Risk Difference (RD)|5.0||||1|TWO_SIDED|95.0|-31.1|41.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Responders, Week 36||41.1|-31.1|1.000
72354569|NCT02365649|144227506|SUPERIORITY||Risk Difference (RD)|-7.5||||0.635|TWO_SIDED|95.0|-38.6|23.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Responders, Week 36||23.6|-38.6|0.635
72354570|NCT02365649|144227506|SUPERIORITY||Risk Difference (RD)|-40.0||||0.056|TWO_SIDED|95.0|-74.8|-5.2||Statistically significant at 0.1 level. P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Responders, Week 36||-5.2|-74.8|0.056
72354571|NCT02365649|144227506|SUPERIORITY||Risk Difference (RD)|-7.5||||1|TWO_SIDED|95.0|-47.5|32.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Responders, Week 44||32.5|-47.5|1.000
72354572|NCT02365649|144227506|SUPERIORITY||Risk Difference (RD)|17.5||||0.296|TWO_SIDED|95.0|-14.7|49.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Responders, Week 44||49.7|-14.7|0.296
72354573|NCT02365649|144227506|SUPERIORITY||Risk Difference (RD)|-5.0||||1|TWO_SIDED|95.0|-42.4|32.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Responders, Week 44||32.4|-42.4|1.000
72354574|NCT02365649|144227506|SUPERIORITY||Risk Difference (RD)|-5.0||||1|TWO_SIDED|95.0|-45.9|35.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Responders, Week 52||35.9|-45.9|1.000
72354575|NCT02365649|144227506|SUPERIORITY||Risk Difference (RD)|13.8||||0.4|TWO_SIDED|95.0|-17.7|45.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Responders, Week 52||45.2|-17.7|0.400
72354576|NCT02365649|144227506|SUPERIORITY||Risk Difference (RD)|-15.0||||0.439|TWO_SIDED|95.0|-52.4|22.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Responders, Week 52||22.4|-52.4|0.439
72354577|NCT02365649|144227506|SUPERIORITY||Risk Difference (RD)|21.9||||0.259|TWO_SIDED|95.0|-12.8|56.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Non-responders, Week 20||56.6|-12.8|0.259
72354578|NCT02365649|144227506|SUPERIORITY||Risk Difference (RD)|-10.5||||0.31|TWO_SIDED|95.0|-30.6|9.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Non-responders, Week 20||9.7|-30.6|0.310
72354579|NCT02365649|144227506|SUPERIORITY||Risk Difference (RD)|-19.4||||0.097|TWO_SIDED|95.0|-38.8|-0.1||Statistically significant at 0.1 level. P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Non-responders, Week 20||-0.1|-38.8|0.097
72354580|NCT02365649|144227506|SUPERIORITY||Risk Difference (RD)|24.4||||0.181|TWO_SIDED|95.0|-8.5|57.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Non-responders, Week 28||57.2|-8.5|0.181
72354581|NCT02365649|144227506|SUPERIORITY||Risk Difference (RD)|2.0||||0.826|TWO_SIDED|95.0|-15.9|20.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Non-responders, Week 28||20.0|-15.9|0.826
72354582|NCT02365649|144227506|SUPERIORITY||Risk Difference (RD)|-2.6||||1|TWO_SIDED|95.0|-21.2|16.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Non-responders, Week 28||16.1|-21.2|1.000
72429247|NCT03615482|144369535|OTHER|Difference in Percent vs. Non-concomitant Group|Difference in Percent|-2.1||||0.31|TWO_SIDED|95.0|-6.2|2.0|||Miettinen & Nurminen|Estimated differences, confidence intervals (CIs), and p-values were calculated based on Miettinen \& Nurminen method.||Injection-Site Swelling||2.0|-6.2|0.310
72354583|NCT02365649|144227506|SUPERIORITY||Risk Difference (RD)|14.4||||0.369|TWO_SIDED|95.0|-16.7|45.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Non-responders, Week 36||45.4|-16.7|0.369
72354584|NCT02365649|144227506|SUPERIORITY||Risk Difference (RD)|-0.9||||1|TWO_SIDED|95.0|-18.2|16.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Non-responders, Week 36||16.4|-18.2|1.000
72354585|NCT02365649|144227506|SUPERIORITY||Risk Difference (RD)|-2.6||||1|TWO_SIDED|95.0|-21.2|16.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Non-responders, Week 36||16.1|-21.2|1.000
72354586|NCT02365649|144227506|SUPERIORITY||Risk Difference (RD)|11.3||||0.66|TWO_SIDED|95.0|-20.2|42.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Non-responders, Week 44||42.7|-20.2|0.660
72354587|NCT02365649|144227506|SUPERIORITY||Risk Difference (RD)|-1.1||||0.908|TWO_SIDED|95.0|-19.7|17.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Non-responders, Week 44||17.5|-19.7|0.908
72354588|NCT02365649|144227506|SUPERIORITY||Risk Difference (RD)|-10.1||||0.446|TWO_SIDED|95.0|-27.8|7.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Non-responders, Week 44||7.7|-27.8|0.446
72354589|NCT02365649|144227506|SUPERIORITY||Risk Difference (RD)|20.6||||0.135|TWO_SIDED|95.0|-9.5|50.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Non-responders, Week 52||50.8|-9.5|0.135
72354590|NCT02365649|144227506|SUPERIORITY||Risk Difference (RD)|11.2||||0.306|TWO_SIDED|95.0|-5.7|28.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Non-responders, Week 52||28.1|-5.7|0.306
72354591|NCT02365649|144227506|SUPERIORITY||Risk Difference (RD)|3.7||||0.686|TWO_SIDED|95.0|-13.4|20.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Non-responders, Week 52||20.7|-13.4|0.686
72354592|NCT02365649|144227506|SUPERIORITY||Risk Difference (RD)|4.9||||0.754|TWO_SIDED|95.0|-25.4|35.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical responders, Week 20||35.2|-25.4|0.754
72354593|NCT02365649|144227506|SUPERIORITY||Risk Difference (RD)|-7.7||||0.548|TWO_SIDED|95.0|-32.6|17.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical responders, Week 20||17.3|-32.6|0.548
72354594|NCT02365649|144227506|SUPERIORITY||Risk Difference (RD)|-22.5||||0.12|TWO_SIDED|95.0|-50.1|5.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical responders, Week 20||5.0|-50.1|0.120
72354595|NCT02365649|144227506|SUPERIORITY||Risk Difference (RD)|-13.4||||0.403|TWO_SIDED|95.0|-44.5|17.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical responders, Week 28||17.7|-44.5|0.403
72354596|NCT02365649|144227506|SUPERIORITY||Risk Difference (RD)|-8.0||||0.533|TWO_SIDED|95.0|-33.0|17.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical responders, Week 28||17.0|-33.0|0.533
72354597|NCT02365649|144227506|SUPERIORITY||Risk Difference (RD)|-8.9||||0.539|TWO_SIDED|95.0|-37.2|19.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical responders, Week 28||19.4|-37.2|0.539
72354598|NCT02365649|144227506|SUPERIORITY||Risk Difference (RD)|4.9||||0.754|TWO_SIDED|95.0|-25.4|35.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical responders, Week 36||35.2|-25.4|0.754
72354599|NCT02365649|144227506|SUPERIORITY||Risk Difference (RD)|-14.5||||0.256|TWO_SIDED|95.0|-39.4|10.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical responders, Week 36||10.3|-39.4|0.256
72354600|NCT02365649|144227506|SUPERIORITY||Risk Difference (RD)|-27.8||||0.055|TWO_SIDED|95.0|-54.7|-0.8||Statistically significant at 0.1 level.|Chi-squared|P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical responders, Week 36||-0.8|-54.7|0.055
72354601|NCT02365649|144227506|SUPERIORITY||Risk Difference (RD)|2.2||||0.887|TWO_SIDED|95.0|-28.8|33.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical responders, Week 44||33.2|-28.8|0.887
72354602|NCT02365649|144227506|SUPERIORITY||Risk Difference (RD)|14.5||||0.256|TWO_SIDED|95.0|-10.3|39.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical responders, Week 44||39.4|-10.3|0.256
72354603|NCT02365649|144227506|SUPERIORITY||Risk Difference (RD)|-9.0||||0.518|TWO_SIDED|95.0|-36.0|17.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical responders, Week 44||17.9|-36.0|0.518
72354604|NCT02365649|144227506|SUPERIORITY||Risk Difference (RD)|6.3||||0.695|TWO_SIDED|95.0|-25.1|37.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical responders, Week 52||37.6|-25.1|0.695
72354605|NCT02365649|144227506|SUPERIORITY||Risk Difference (RD)|11.4||||0.373|TWO_SIDED|95.0|-13.5|36.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical responders, Week 52||36.4|-13.5|0.373
72354606|NCT02365649|144227506|SUPERIORITY||Risk Difference (RD)|-6.9||||0.628|TWO_SIDED|95.0|-34.6|20.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical responders, Week 52||20.8|-34.6|0.628
72354607|NCT02365649|144227506|SUPERIORITY||Risk Difference (RD)|-15.0||||1|TWO_SIDED|95.0|-30.6|0.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical non-responders, Week 20||0.6|-30.6|1.000
72354608|NCT02365649|144227506|SUPERIORITY||Risk Difference (RD)|-0.7||||1|TWO_SIDED|95.0|-22.4|20.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical non-responders, Week 20||20.9|-22.4|1.000
72354609|NCT02365649|144227506|SUPERIORITY||Risk Difference (RD)|-15.0||||0.251|TWO_SIDED|95.0|-30.6|0.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical non-responders, Week 20||0.6|-30.6|0.251
72354610|NCT02365649|144227506|SUPERIORITY||Risk Difference (RD)|-10.0||||1|TWO_SIDED|95.0|-23.1|3.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical non-responders, Week 28||3.1|-23.1|1.000
72354611|NCT02365649|144227506|SUPERIORITY||Risk Difference (RD)|-0.5||||1|TWO_SIDED|95.0|-18.7|17.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical non-responders, Week 28||17.7|-18.7|1.000
72354612|NCT02365649|144227506|SUPERIORITY||Risk Difference (RD)|-10.0||||0.501|TWO_SIDED|95.0|-23.1|3.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical non-responders, Week 28||3.1|-23.1|0.501
72354613|NCT02365649|144227506|SUPERIORITY||Risk Difference (RD)|9.5||||0.488|TWO_SIDED|95.0|-3.0|22.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical non-responders, Week 36||22.1|-3.0|0.488
72429248|NCT03615482|144369536|OTHER|Difference in Percent vs. Non-concomitant Group|Difference in Percent|-2.2||||0.205|TWO_SIDED|95.0|-5.8|1.2|||Miettinen & Nurminen|Estimated differences, confidence intervals (CIs), and p-values were calculated based on Miettinen \& Nurminen method.||Arthralgia||1.2|-5.8|0.205
72354614|NCT02365649|144227506|SUPERIORITY||Risk Difference (RD)|-10.0||||1|TWO_SIDED|95.0|-23.1|3.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical non-responders, Week 44||3.1|-23.1|1.000
72354615|NCT02365649|144227506|SUPERIORITY||Risk Difference (RD)|-10.0||||0.232|TWO_SIDED|95.0|-23.1|3.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical non-responders, Week 44||3.1|-23.1|0.232
72354616|NCT02365649|144227506|SUPERIORITY||Risk Difference (RD)|-10.0||||0.501|TWO_SIDED|95.0|-23.1|3.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical non-responders, Week 44||3.1|-23.1|0.501
72354617|NCT02365649|144227506|SUPERIORITY||Risk Difference (RD)|9.5||||0.488|TWO_SIDED|95.0|-3.0|22.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical non-responders, Week 52||22.1|-3.0|0.488
72354618|NCT02365649|144227507|SUPERIORITY||Risk Difference (RD)|20.0||||0.295|TWO_SIDED|95.0|2.5|37.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Responders, Week 20||37.5|2.5|0.295
72354619|NCT02365649|144227507|SUPERIORITY||Risk Difference (RD)|13.8||||0.355|TWO_SIDED|95.0|-7.4|34.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Responders, Week 20||34.9|-7.4|0.355
72354620|NCT02365649|144227507|SUPERIORITY||Risk Difference (RD)|-20.0||||0.384|TWO_SIDED|95.0|-55.1|15.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Responders, Week 20||15.1|-55.1|0.384
72354621|NCT02365649|144227507|SUPERIORITY||Risk Difference (RD)|-22.5||||0.311|TWO_SIDED|95.0|-59.5|14.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Responders, Week 28||14.5|-59.5|0.311
72354622|NCT02365649|144227507|SUPERIORITY||Risk Difference (RD)|-16.3||||0.422|TWO_SIDED|95.0|-43.8|11.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Responders, Week 28||11.3|-43.8|0.422
72429249|NCT03615482|144369536|OTHER|Difference in Percent vs. Non-concomitant Group|Difference in Percent|-2.9||||0.273|TWO_SIDED|95.0|-8.0|2.3|||Miettinen & Nurminen|Estimated differences, confidence intervals (CIs), and p-values were calculated based on Miettinen \& Nurminen method.||Fatigue||2.3|-8.0|0.273
72354623|NCT02365649|144227507|SUPERIORITY||Risk Difference (RD)|-25.0||||0.181|TWO_SIDED|95.0|-59.2|9.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Responders, Week 28||9.2|-59.2|0.181
72354624|NCT02365649|144227507|SUPERIORITY||Risk Difference (RD)|25.0||||0.281|TWO_SIDED|95.0|6.0|44.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Responders, Week 36||44.0|6.0|0.281
72354625|NCT02365649|144227507|SUPERIORITY||Risk Difference (RD)|0.0||||1|TWO_SIDED|95.0|-28.5|28.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Responders, Week 36||28.5|-28.5|1.000
72354626|NCT02365649|144227507|SUPERIORITY||Risk Difference (RD)|-25.0||||0.231|TWO_SIDED|95.0|-61.3|11.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Responders, Week 36||11.3|-61.3|0.231
72354627|NCT02365649|144227507|SUPERIORITY||Risk Difference (RD)|27.5||||0.214|TWO_SIDED|95.0|-3.9|58.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Responders, Week 44||58.9|-3.9|0.214
72429250|NCT03615482|144369536|OTHER|Difference in Percent vs. Non-concomitant Group|Difference in Percent|-2.2||||0.372|TWO_SIDED|95.0|-6.9|2.6|||Miettinen & Nurminen|Estimated differences, confidence intervals (CIs), and p-values were calculated based on Miettinen \& Nurminen method.||Headache||2.6|-6.9|0.372
72429251|NCT03615482|144369536|OTHER|Difference in Percent vs. Non-concomitant Group|Difference in Percent|2.4||||0.329|TWO_SIDED|95.0|-2.4|7.1|||Miettinen & Nurminen|Estimated differences, confidence intervals (CIs), and p-values were calculated based on Miettinen \& Nurminen method.||Myalgia||7.1|-2.4|0.329
72354628|NCT02365649|144227507|SUPERIORITY||Risk Difference (RD)|21.3||||0.277|TWO_SIDED|95.0|-7.5|50.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Responders, Week 44||50.0|-7.5|0.277
72354629|NCT02365649|144227507|SUPERIORITY||Risk Difference (RD)|-20.0||||0.442|TWO_SIDED|95.0|-57.2|17.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Responders, Week 44||17.2|-57.2|0.442
72354630|NCT02365649|144227507|SUPERIORITY||Risk Difference (RD)|20.0||||0.419|TWO_SIDED|95.0|-17.1|57.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Responders, Week 52||57.1|-17.1|0.419
72354631|NCT02365649|144227507|SUPERIORITY||Risk Difference (RD)|20.0||||0.214|TWO_SIDED|95.0|-10.4|50.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Responders, Week 52||50.4|-10.4|0.214
72354632|NCT02365649|144227507|SUPERIORITY||Risk Difference (RD)|-15.0||||0.439|TWO_SIDED|95.0|-52.4|22.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Responders, Week 52||22.4|-52.4|0.439
72354633|NCT02365649|144227507|SUPERIORITY||Risk Difference (RD)|23.1||||0.284|TWO_SIDED|95.0|-10.1|56.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Non-responders, Week 20||56.4|-10.1|0.284
72354634|NCT02365649|144227507|SUPERIORITY||Risk Difference (RD)|0.2||||0.988|TWO_SIDED|95.0|-23.9|24.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Non-responders, Week 20||24.3|-23.9|0.988
72354635|NCT02365649|144227507|SUPERIORITY||Risk Difference (RD)|-12.1||||0.37|TWO_SIDED|95.0|-38.1|13.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Non-responders, Week 20||13.9|-38.1|0.370
72354636|NCT02365649|144227507|SUPERIORITY||Risk Difference (RD)|25.6||||0.268|TWO_SIDED|95.0|-8.9|60.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Non-responders, Week 28||60.2|-8.9|0.268
72354637|NCT02365649|144227507|SUPERIORITY||Risk Difference (RD)|-5.0||||0.665|TWO_SIDED|95.0|-27.4|17.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Non-responders, Week 28||17.5|-27.4|0.665
72354638|NCT02365649|144227507|SUPERIORITY||Risk Difference (RD)|-3.9||||0.759|TWO_SIDED|95.0|-28.9|21.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Non-responders, Week 28||21.0|-28.9|0.759
72354639|NCT02365649|144227507|SUPERIORITY||Risk Difference (RD)|21.9||||0.259|TWO_SIDED|95.0|-12.8|56.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Non-responders, Week 36||56.6|-12.8|0.259
72429252|NCT03615482|144369537|OTHER||Difference in Percent|0.0|||||TWO_SIDED|95.0|-0.6|0.6||||||||0.6|-0.6|
72354640|NCT02365649|144227507|SUPERIORITY||Risk Difference (RD)|-1.7||||0.88|TWO_SIDED|95.0|-23.2|19.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Non-responders, Week 36||19.9|-23.2|0.880
72354641|NCT02365649|144227507|SUPERIORITY||Risk Difference (RD)|-10.7||||0.355|TWO_SIDED|95.0|-32.7|11.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Non-responders, Week 36||11.2|-32.7|0.355
72429253|NCT03615482|144369538|NON_INFERIORITY|Non-inferiority is based on the lower bound of the 95% confidence interval (CI) on the estimated GMT ratio (Concomitant Group/Nonconcomitant Group) being \>0.5 (one-sided p-value \< 0.025).|GMT Ratio|0.66||||0.004|TWO_SIDED|95.0|0.54|0.82|||cLDA|GMT ratio, 95% CI and p-value were estimated from a constrained longitudinal data analysis (cLDA) model including all vaccinated participants.||Serotype 1||0.82|0.54|0.004
72429254|NCT03615482|144369538|NON_INFERIORITY|Non-inferiority is based on the lower bound of the 95% confidence interval (CI) on the estimated GMT ratio (Concomitant Group/Nonconcomitant Group) being \>0.5 (one-sided p-value \< 0.025).|GMT Ratio|0.94|||<|0.001|TWO_SIDED|95.0|0.81|1.09|||cLDA|GMT ratio, 95% CI and p-value were estimated from a cLDA model.||Serotype 3||1.09|0.81|<0.001
72354642|NCT02365649|144227507|SUPERIORITY||Risk Difference (RD)|5.0||||1|TWO_SIDED|95.0|-27.1|37.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Non-responders, Week 44||37.1|-27.1|1.000
72354643|NCT02365649|144227507|SUPERIORITY||Risk Difference (RD)|4.4||||0.688|TWO_SIDED|95.0|-17.0|25.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Non-responders, Week 44||25.9|-17.0|0.688
72354644|NCT02365649|144227507|SUPERIORITY||Risk Difference (RD)|1.1||||0.927|TWO_SIDED|95.0|-22.3|24.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Non-responders, Week 44||24.5|-22.3|0.927
72354645|NCT02365649|144227507|SUPERIORITY||Risk Difference (RD)|27.5||||0.075|TWO_SIDED|95.0|-5.0|60.0||Statistically significant at 0.1 level. P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Non-responders, Week 52||60.0|-5.0|0.075
72354646|NCT02365649|144227507|SUPERIORITY||Risk Difference (RD)|14.0||||0.154|TWO_SIDED|95.0|-4.8|32.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Non-responders, Week 52||32.7|-4.8|0.154
72354647|NCT02365649|144227507|SUPERIORITY||Risk Difference (RD)|4.9||||0.707|TWO_SIDED|95.0|-14.4|24.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Non-responders, Week 52||24.2|-14.4|0.707
72354648|NCT02365649|144227507|SUPERIORITY||Risk Difference (RD)|25.0||||0.085|TWO_SIDED|95.0|10.0|40.0||Statistically significant at 0.1 level. P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical responders, Week 20||40.0|10.0|0.085
72354649|NCT02365649|144227507|SUPERIORITY||Risk Difference (RD)|14.7||||0.137|TWO_SIDED|95.0|-4.0|33.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical responders, Week 20||33.3|-4.0|0.137
72354650|NCT02365649|144227507|SUPERIORITY||Risk Difference (RD)|-11.8||||0.37|TWO_SIDED|95.0|-38.2|14.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical responders, Week 20||14.5|-38.2|0.370
72354651|NCT02365649|144227507|SUPERIORITY||Risk Difference (RD)|-3.6||||1|TWO_SIDED|95.0|-31.6|24.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical responders, Week 28||24.4|-31.6|1.000
72354652|NCT02365649|144227507|SUPERIORITY||Risk Difference (RD)|-16.4||||0.174|TWO_SIDED|95.0|-39.8|7.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical responders, Week 28||7.0|-39.8|0.174
72354653|NCT02365649|144227507|SUPERIORITY||Risk Difference (RD)|-17.1||||0.203|TWO_SIDED|95.0|-43.9|9.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical responders, Week 28||9.7|-43.9|0.203
72429255|NCT03615482|144369538|NON_INFERIORITY|Non-inferiority is based on the lower bound of the 95% confidence interval (CI) on the estimated GMT ratio (Concomitant Group/Nonconcomitant Group) being \>0.5 (one-sided p-value \< 0.025).|GMT Ratio|0.84|||<|0.001|TWO_SIDED|95.0|0.69|1.01|||cLDA|GMT ratio, 95% CI and p-value were estimated from a cLDA model.||Serotype 4||1.01|0.69|<0.001
72354654|NCT02365649|144227507|SUPERIORITY||Risk Difference (RD)|20.1||||0.286|TWO_SIDED|95.0|-4.5|44.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical responders, Week 36||44.7|-4.5|0.286
72354655|NCT02365649|144227507|SUPERIORITY||Risk Difference (RD)|-3.6||||0.773|TWO_SIDED|95.0|-27.7|20.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical responders, Week 36||20.6|-27.7|0.773
72429256|NCT03615482|144369538|NON_INFERIORITY|Non-inferiority is based on the lower bound of the 95% confidence interval (CI) on the estimated GMT ratio (Concomitant Group/Nonconcomitant Group) being \>0.5 (one-sided p-value \< 0.025).|GMT Ratio|0.79|||<|0.001|TWO_SIDED|95.0|0.64|0.98|||cLDA|GMT ratio, 95% CI and p-value were estimated from a cLDA model.||Serotype 5||0.98|0.64|<0.001
72354656|NCT02365649|144227507|SUPERIORITY||Risk Difference (RD)|-23.5||||0.101|TWO_SIDED|95.0|-51.2|4.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical responders, Week 36||4.1|-51.2|0.101
72354657|NCT02365649|144227507|SUPERIORITY||Risk Difference (RD)|15.2||||0.332|TWO_SIDED|95.0|-14.1|44.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical responders, Week 44||44.4|-14.1|0.332
72354658|NCT02365649|144227507|SUPERIORITY||Risk Difference (RD)|16.2||||0.189|TWO_SIDED|95.0|-7.5|39.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical responders, Week 44||39.8|-7.5|0.189
72354659|NCT02365649|144227507|SUPERIORITY||Risk Difference (RD)|-14.1||||0.329|TWO_SIDED|95.0|-42.2|13.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical responders, Week 44||13.9|-42.2|0.329
72354660|NCT02365649|144227507|SUPERIORITY||Risk Difference (RD)|24.6||||0.124|TWO_SIDED|95.0|-4.8|53.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical responders, Week 52||53.9|-4.8|0.124
72354661|NCT02365649|144227507|SUPERIORITY||Risk Difference (RD)|15.2||||0.234|TWO_SIDED|95.0|-9.5|39.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical responders, Week 52||39.9|-9.5|0.234
72354662|NCT02365649|144227507|SUPERIORITY||Risk Difference (RD)|-10.0||||0.484|TWO_SIDED|95.0|-37.8|17.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical responders, Week 52||17.7|-37.8|0.484
72354663|NCT02365649|144227507|SUPERIORITY||Risk Difference (RD)|-10.0||||1|TWO_SIDED|95.0|-57.3|37.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical non-responders, Week 20||37.3|-57.3|1.000
72354664|NCT02365649|144227507|SUPERIORITY||Risk Difference (RD)|-11.2||||0.431|TWO_SIDED|95.0|-38.9|16.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical non-responders, Week 20||16.5|-38.9|0.431
72354665|NCT02365649|144227507|SUPERIORITY||Risk Difference (RD)|-20.7||||0.25|TWO_SIDED|95.0|-48.5|7.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical non-responders, Week 20||7.1|-48.5|0.250
72354666|NCT02365649|144227507|SUPERIORITY||Risk Difference (RD)|5.0||||1|TWO_SIDED|95.0|-40.9|50.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical non-responders, Week 28||50.9|-40.9|1.000
72429257|NCT03615482|144369538|NON_INFERIORITY|Non-inferiority is based on the lower bound of the 95% confidence interval (CI) on the estimated GMT ratio (Concomitant Group/Nonconcomitant Group) being \>0.5 (one-sided p-value \< 0.025).|GMT Ratio|0.84|||<|0.001|TWO_SIDED|95.0|0.71|1.0|||cLDA|GMT ratio, 95% CI and p-value were estimated from a cLDA model.||Serotype 6A||1.00|0.71|<0.001
72429258|NCT03615482|144369538|NON_INFERIORITY|Non-inferiority is based on the lower bound of the 95% confidence interval (CI) on the estimated GMT ratio (Concomitant Group/Nonconcomitant Group) being \>0.5 (one-sided p-value \< 0.025).|GMT Ratio|0.88|||<|0.001|TWO_SIDED|95.0|0.74|1.04|||cLDA|GMT ratio, 95% CI and p-value were estimated from a cLDA model.||Serotype 6B||1.04|0.74|<0.001
72354667|NCT02365649|144227507|SUPERIORITY||Risk Difference (RD)|-1.0||||1|TWO_SIDED|95.0|-25.2|23.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical non-responders, Week 28||23.3|-25.2|1.000
72354668|NCT02365649|144227507|SUPERIORITY||Risk Difference (RD)|-5.7||||1|TWO_SIDED|95.0|-31.1|19.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical non-responders, Week 28||19.6|-31.1|1.000
72429259|NCT03615482|144369538|NON_INFERIORITY|Non-inferiority is based on the lower bound of the 95% confidence interval (CI) on the estimated GMT ratio (Concomitant Group/Nonconcomitant Group) being \>0.5 (one-sided p-value \< 0.025).|GMT Ratio|0.86|||<|0.001|TWO_SIDED|95.0|0.75|0.99|||cLDA|GMT ratio, 95% CI and p-value were estimated from a cLDA model.||Serotype 7F||0.99|0.75|<0.001
72354669|NCT02365649|144227507|SUPERIORITY||Risk Difference (RD)|10.0||||0.544|TWO_SIDED|95.0|-35.2|55.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical non-responders, Week 36||55.2|-35.2|0.544
72354670|NCT02365649|144227507|SUPERIORITY||Risk Difference (RD)|-0.7||||1|TWO_SIDED|95.0|-22.4|20.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical non-responders, Week 36||20.9|-22.4|1.000
72354671|NCT02365649|144227507|SUPERIORITY||Risk Difference (RD)|-7.9||||0.627|TWO_SIDED|95.0|-28.5|12.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical non-responders, Week 36||12.8|-28.5|0.627
72354672|NCT02365649|144227507|SUPERIORITY||Risk Difference (RD)|-10.0||||1|TWO_SIDED|95.0|-23.1|3.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical non-responders, Week 44||3.1|-23.1|1.000
72354673|NCT02365649|144227507|SUPERIORITY||Risk Difference (RD)|-0.5||||1|TWO_SIDED|95.0|-18.7|17.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical non-responders, Week 44||17.7|-18.7|1.000
72354674|NCT02365649|144227507|SUPERIORITY||Risk Difference (RD)|4.3||||1|TWO_SIDED|95.0|-18.3|26.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical non-responders, Week 44||26.8|-18.3|1.000
72354675|NCT02365649|144227507|SUPERIORITY||Risk Difference (RD)|14.3||||0.232|TWO_SIDED|95.0|-0.7|29.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical non-responders, Week 52||29.3|-0.7|0.232
72354676|NCT02365649|144227507|SUPERIORITY||Risk Difference (RD)|7.1||||0.412|TWO_SIDED|95.0|-6.3|20.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical non-responders, Week 52||20.6|-6.3|0.412
72354677|NCT02365649|144227508|SUPERIORITY||LS Mean of Difference|-745.7||||0.356|TWO_SIDED|95.0|-2369.73|878.37||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Responders, Week 28||878.37|-2369.73|0.356
72354678|NCT02365649|144227508|SUPERIORITY||LS Mean of Difference|-1119.5||||0.158|TWO_SIDED|95.0|-2698.52|459.5||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Responders, Week 28||459.50|-2698.52|0.158
72354679|NCT02365649|144227508|SUPERIORITY||LS Mean of Difference|-1166.0||||0.322|TWO_SIDED|95.0|-3531.3|1199.32||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Responders, Week 28||1199.32|-3531.30|0.322
72354680|NCT02365649|144227508|SUPERIORITY||LS Mean of Difference|-828.2||||0.287|TWO_SIDED|95.0|-2387.16|730.75||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Responders, Week 52||730.75|-2387.16|0.287
72354681|NCT02365649|144227508|SUPERIORITY||LS Mean of Difference|-1286.1||||0.088|TWO_SIDED|95.0|-2772.59|200.43||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|Prespecified statistically significant at 0.1 level.||Responders, Week 52||200.43|-2772.59|0.088
72354682|NCT02365649|144227508|SUPERIORITY||LS Mean of Difference|-502.2||||0.613|TWO_SIDED|95.0|-2505.74|1501.38||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Responders, Week 52||1501.38|-2505.74|0.613
72354683|NCT02365649|144227508|SUPERIORITY||LS Mean of Difference|283.4||||0.609|TWO_SIDED|95.0|-823.64|1390.49||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Non-responders, Week 28||1390.49|-823.64|0.609
72354684|NCT02365649|144227508|SUPERIORITY||LS Mean of Difference|-78.2||||0.855|TWO_SIDED|95.0|-930.47|774.16||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Non-responders, Week 28||774.16|-930.47|0.855
72354685|NCT02365649|144227508|SUPERIORITY||LS Mean of Difference|283.5||||0.584|TWO_SIDED|95.0|-751.66|1318.57||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Non-responders, Week 28||1318.57|-751.66|0.584
72354686|NCT02365649|144227508|SUPERIORITY||LS Mean of Difference|356.6||||0.624|TWO_SIDED|95.0|-1095.03|1808.19||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Non-responders, Week 52||1808.19|-1095.03|0.624
72354687|NCT02365649|144227508|SUPERIORITY||LS Mean of Difference|-135.1||||0.806|TWO_SIDED|95.0|-1233.48|963.25||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Non-responders, Week 52||963.25|-1233.48|0.806
72354688|NCT02365649|144227508|SUPERIORITY||LS Mean of Difference|186.2||||0.793|TWO_SIDED|95.0|-1229.59|1602.06||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Non-responders, Week 52||1602.06|-1229.59|0.793
72354689|NCT02365649|144227508|SUPERIORITY||LS Mean of Difference|-304.8||||0.561|TWO_SIDED|95.0|-1350.04|740.44||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Clinical responders, Week 28||740.44|-1350.04|0.561
72354690|NCT02365649|144227508|SUPERIORITY||LS Mean of Difference|-1119.0||||0.024|TWO_SIDED|95.0|-2083.81|-154.11||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|Prespecified statistically significant at 0.05 level.||Clinical responders, Week 28||-154.11|-2083.81|0.024
72354691|NCT02365649|144227508|SUPERIORITY||LS Mean of Difference|-819.3||||0.156|TWO_SIDED|95.0|-1959.79|321.21||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Clinical responders, Week 28||321.21|-1959.79|0.156
72354692|NCT02365649|144227508|SUPERIORITY||LS Mean of Difference|-346.6||||0.58|TWO_SIDED|95.0|-1592.66|899.45||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Clinical responders, Week 52||899.45|-1592.66|0.580
72354693|NCT02365649|144227508|SUPERIORITY||LS Mean of Difference|-1275.9||||0.029|TWO_SIDED|95.0|-2415.88|-135.92||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|Prespecified statistically significant at 0.05 level.||Clinical responders, Week 52||-135.92|-2415.88|0.029
72354694|NCT02365649|144227508|SUPERIORITY||LS Mean of Difference|-534.9||||0.431|TWO_SIDED|95.0|-1883.23|813.5||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Clinical responders, Week 52||813.50|-1883.23|0.431
72354695|NCT02365649|144227508|SUPERIORITY||LS Mean of Difference|-25.4||||0.965|TWO_SIDED|95.0|-1200.67|1149.95||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Clinical non-responders, Week 28||1149.95|-1200.67|0.965
72354696|NCT02365649|144227508|SUPERIORITY||LS Mean of Difference|623.6||||0.123|TWO_SIDED|95.0|-183.52|1430.64||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Clinical non-responders, Week 28||1430.64|-183.52|0.123
72354697|NCT02365649|144227508|SUPERIORITY||LS Mean of Difference|368.2||||0.591|TWO_SIDED|95.0|-1031.23|1767.6||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Clinical non-responders, Week 28||1767.60|-1031.23|0.591
72354698|NCT02365649|144227508|SUPERIORITY||LS Mean of Difference|192.2||||0.642|TWO_SIDED|95.0|-648.22|1032.68||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Clinical non-responders, Week 52||1032.68|-648.22|0.642
72354699|NCT02365649|144227508|SUPERIORITY||LS Mean of Difference|455.8||||0.093|TWO_SIDED|95.0|-81.37|992.95||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|Prespecified statistically significant at 0.1 level.||Clinical non-responders, Week 52||992.95|-81.37|0.093
72354700|NCT02365649|144227508|SUPERIORITY||LS Mean of Difference|463.6||||0.296|TWO_SIDED|95.0|-428.99|1356.2||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Clinical non-responders, Week 52||1356.20|-428.99|0.296
72354701|NCT02365649|144227509|SUPERIORITY||LS Mean of Difference|-2.0||||0.822|TWO_SIDED|95.0|-19.83|15.83||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Responders, Week 20||15.83|-19.83|0.822
72354702|NCT02365649|144227509|SUPERIORITY||LS Mean of Difference|-6.4||||0.386|TWO_SIDED|95.0|-20.97|8.25||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Responders, Week 20||8.25|-20.97|0.386
72354703|NCT02365649|144227509|SUPERIORITY||LS Mean of Difference|12.9||||0.136|TWO_SIDED|95.0|-4.22|29.95||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Responders, Week 20||29.95|-4.22|0.136
72354704|NCT02365649|144227509|SUPERIORITY||LS Mean of Difference|1.0||||0.912|TWO_SIDED|95.0|-17.87|19.97||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Responders, Week 28||19.97|-17.87|0.912
72354705|NCT02365649|144227509|SUPERIORITY||LS Mean of Difference|-12.3||||0.118|TWO_SIDED|95.0|-27.77|3.25||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Responders, Week 28||3.25|-27.77|0.118
72354706|NCT02365649|144227509|SUPERIORITY||LS Mean of Difference|12.5||||0.171|TWO_SIDED|95.0|-5.61|30.65||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Responders, Week 28||30.65|-5.61|0.171
72354707|NCT02365649|144227509|SUPERIORITY||LS Mean of Difference|-6.9||||0.479|TWO_SIDED|95.0|-26.5|12.63||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Responders, Week 36||12.63|-26.50|0.479
72354708|NCT02365649|144227509|SUPERIORITY||LS Mean of Difference|-17.1||||0.037|TWO_SIDED|95.0|-33.12|-1.04||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|Prespecified statistically significant at 0.05 level.||Responders, Week 36||-1.04|-33.12|0.037
72354709|NCT02365649|144227509|SUPERIORITY||LS Mean of Difference|6.9||||0.463|TWO_SIDED|95.0|-11.86|25.65||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Responders, Week 36||25.65|-11.86|0.463
72354710|NCT02365649|144227509|SUPERIORITY||LS Mean of Difference|-4.6||||0.627|TWO_SIDED|95.0|-23.59|14.37||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Responders, Week 44||14.37|-23.59|0.627
72354711|NCT02365649|144227509|SUPERIORITY||LS Mean of Difference|-12.2||||0.122|TWO_SIDED|95.0|-27.75|3.37||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Responders, Week 44||3.37|-27.75|0.122
72354712|NCT02365649|144227509|SUPERIORITY||LS Mean of Difference|10.7||||0.243|TWO_SIDED|95.0|-7.49|28.89||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Responders, Week 44||28.89|-7.49|0.243
72354713|NCT02365649|144227509|SUPERIORITY||LS Mean of Difference|-4.2||||0.658|TWO_SIDED|95.0|-22.95|14.63||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Responders, Week 52||14.63|-22.95|0.658
72429260|NCT03615482|144369538|NON_INFERIORITY|Non-inferiority is based on the lower bound of the 95% confidence interval (CI) on the estimated GMT ratio (Concomitant Group/Nonconcomitant Group) being \>0.5 (one-sided p-value \< 0.025).|GMT Ratio|0.99|||<|0.001|TWO_SIDED|95.0|0.86|1.15|||cLDA|GMT ratio, 95% CI and p-value were estimated from a cLDA model.||Serotype 9V||1.15|0.86|<0.001
72354714|NCT02365649|144227509|SUPERIORITY||LS Mean of Difference|-12.3||||0.115|TWO_SIDED|95.0|-27.69|3.12||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Responders, Week 52||3.12|-27.69|0.115
72354715|NCT02365649|144227509|SUPERIORITY||LS Mean of Difference|10.0||||0.267|TWO_SIDED|95.0|-7.96|28.06||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Responders, Week 52||28.06|-7.96|0.267
72354716|NCT02365649|144227509|SUPERIORITY||LS Mean of Difference|0.2||||0.974|TWO_SIDED|95.0|-9.74|10.06||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Non-responders, Week 20||10.06|-9.74|0.974
72354717|NCT02365649|144227509|SUPERIORITY||LS Mean of Difference|-0.5||||0.882|TWO_SIDED|95.0|-7.61|6.55||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Non-responders, Week 20||6.55|-7.61|0.882
72354718|NCT02365649|144227509|SUPERIORITY||LS Mean of Difference|-0.1||||0.982|TWO_SIDED|95.0|-7.92|7.75||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Non-responders, Week 20||7.75|-7.92|0.982
72354719|NCT02365649|144227509|SUPERIORITY||LS Mean of Difference|2.2||||0.673|TWO_SIDED|95.0|-8.11|12.51||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Non-responders, Week 28||12.51|-8.11|0.673
72354720|NCT02365649|144227509|SUPERIORITY||LS Mean of Difference|2.7||||0.467|TWO_SIDED|95.0|-4.64|10.04||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Non-responders, Week 28||10.04|-4.64|0.467
72354721|NCT02365649|144227509|SUPERIORITY||LS Mean of Difference|2.2||||0.583|TWO_SIDED|95.0|-5.79|10.23||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Non-responders, Week 28||10.23|-5.79|0.583
72354722|NCT02365649|144227509|SUPERIORITY||LS Mean of Difference|5.5||||0.564|TWO_SIDED|95.0|-13.33|24.31||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Non-responders, Week 36||24.31|-13.33|0.564
72354723|NCT02365649|144227509|SUPERIORITY||LS Mean of Difference|-2.4||||0.728|TWO_SIDED|95.0|-15.74|11.04||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Non-responders, Week 36||11.04|-15.74|0.728
72354724|NCT02365649|144227509|SUPERIORITY||LS Mean of Difference|5.5||||0.46|TWO_SIDED|95.0|-9.16|20.08||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Non-responders, Week 36||20.08|-9.16|0.460
72354725|NCT02365649|144227509|SUPERIORITY||LS Mean of Difference|12.0||||0.253|TWO_SIDED|95.0|-8.72|32.75||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Non-responders, Week 44||32.75|-8.72|0.253
72354726|NCT02365649|144227509|SUPERIORITY||LS Mean of Difference|1.1||||0.884|TWO_SIDED|95.0|-13.67|15.84||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Non-responders, Week 44||15.84|-13.67|0.884
72354727|NCT02365649|144227509|SUPERIORITY||LS Mean of Difference|5.8||||0.474|TWO_SIDED|95.0|-10.28|21.95||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Non-responders, Week 44||21.95|-10.28|0.474
72354728|NCT02365649|144227509|SUPERIORITY||LS Mean of Difference|3.6||||0.727|TWO_SIDED|95.0|-17.03|24.3||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Non-responders, Week 52||24.30|-17.03|0.727
72354729|NCT02365649|144227509|SUPERIORITY||LS Mean of Difference|2.1||||0.78|TWO_SIDED|95.0|-12.63|16.78||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Non-responders, Week 52||16.78|-12.63|0.780
72354730|NCT02365649|144227509|SUPERIORITY||LS Mean of Difference|6.5||||0.424|TWO_SIDED|95.0|-9.57|22.54||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Non-responders, Week 52||22.54|-9.57|0.424
72354731|NCT02365649|144227509|SUPERIORITY||LS Mean of Difference|-1.3||||0.841|TWO_SIDED|95.0|-14.23|11.62||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Clinical responders, Week 20||11.62|-14.23|0.841
72429261|NCT03615482|144369538|NON_INFERIORITY|Non-inferiority is based on the lower bound of the 95% confidence interval (CI) on the estimated GMT ratio (Concomitant Group/Nonconcomitant Group) being \>0.5 (one-sided p-value \< 0.025).|GMT Ratio|0.91|||<|0.001|TWO_SIDED|95.0|0.77|1.08|||cLDA|GMT ratio, 95% CI and p-value were estimated from a cLDA model.||Serotype 14||1.08|0.77|<0.001
72429262|NCT03615482|144369538|NON_INFERIORITY|Non-inferiority is based on the lower bound of the 95% confidence interval (CI) on the estimated GMT ratio (Concomitant Group/Nonconcomitant Group) being \>0.5 (one-sided p-value \< 0.025).|GMT Ratio|0.79|||<|0.001|TWO_SIDED|95.0|0.68|0.92|||cLDA|GMT ratio, 95% CI and p-value were estimated from a cLDA model.||Serotype 18C||0.92|0.68|<0.001
72354732|NCT02365649|144227509|SUPERIORITY||LS Mean of Difference|-2.1||||0.702|TWO_SIDED|95.0|-12.94|8.75||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Clinical responders, Week 20||8.75|-12.94|0.702
72354733|NCT02365649|144227509|SUPERIORITY||LS Mean of Difference|5.7||||0.353|TWO_SIDED|95.0|-6.43|17.83||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Clinical responders, Week 20||17.83|-6.43|0.353
72354734|NCT02365649|144227509|SUPERIORITY||LS Mean of Difference|2.1||||0.77|TWO_SIDED|95.0|-11.89|16.0||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Clinical responders, Week 28||16.00|-11.89|0.770
72354735|NCT02365649|144227509|SUPERIORITY||LS Mean of Difference|-5.3||||0.367|TWO_SIDED|95.0|-17.04|6.37||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Clinical responders, Week 28||6.37|-17.04|0.367
72354736|NCT02365649|144227509|SUPERIORITY||LS Mean of Difference|7.0||||0.291|TWO_SIDED|95.0|-6.09|20.07||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Clinical responders, Week 28||20.07|-6.09|0.291
72429263|NCT03615482|144369538|NON_INFERIORITY|Non-inferiority is based on the lower bound of the 95% confidence interval (CI) on the estimated GMT ratio (Concomitant Group/Nonconcomitant Group) being \>0.5 (one-sided p-value \< 0.025).|GMT Ratio|0.83|||<|0.001|TWO_SIDED|95.0|0.73|0.95|||cLDA|GMT ratio, 95% CI and p-value were estimated from a cLDA model.||Serotype 19A||0.95|0.73|<0.001
72354737|NCT02365649|144227509|SUPERIORITY||LS Mean of Difference|-0.7||||0.942|TWO_SIDED|95.0|-20.87|19.4||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Clinical responders, Week 36||19.40|-20.87|0.942
72354738|NCT02365649|144227509|SUPERIORITY||LS Mean of Difference|-12.0||||0.162|TWO_SIDED|95.0|-28.89|4.91||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Clinical responders, Week 36||4.91|-28.89|0.162
72354739|NCT02365649|144227509|SUPERIORITY||LS Mean of Difference|10.9||||0.253|TWO_SIDED|95.0|-7.96|29.82||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Clinical responders, Week 36||29.82|-7.96|0.253
72354740|NCT02365649|144227509|SUPERIORITY||LS Mean of Difference|5.5||||0.617|TWO_SIDED|95.0|-16.25|27.21||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Clinical responders, Week 44||27.21|-16.25|0.617
72354741|NCT02365649|144227509|SUPERIORITY||LS Mean of Difference|-6.0||||0.515|TWO_SIDED|95.0|-24.22|12.24||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Clinical responders, Week 44||12.24|-24.22|0.515
72354742|NCT02365649|144227509|SUPERIORITY||LS Mean of Difference|13.8||||0.18|TWO_SIDED|95.0|-6.53|34.23||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Clinical responders, Week 44||34.23|-6.53|0.180
72354743|NCT02365649|144227509|SUPERIORITY||LS Mean of Difference|-0.4||||0.972|TWO_SIDED|95.0|-21.86|21.09||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Clinical responders, Week 52||21.09|-21.86|0.972
72354744|NCT02365649|144227509|SUPERIORITY||LS Mean of Difference|-4.9||||0.589|TWO_SIDED|95.0|-22.94|13.1||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Clinical responders, Week 52||13.10|-22.94|0.589
72354745|NCT02365649|144227509|SUPERIORITY||LS Mean of Difference|14.1||||0.168|TWO_SIDED|95.0|-6.07|34.22||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Clinical responders, Week 52||34.22|-6.07|0.168
72354746|NCT02365649|144227509|SUPERIORITY||LS Mean of Difference|1.9||||0.712|TWO_SIDED|95.0|-8.5|12.36||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Clinical non-responders, Week 20||12.36|-8.50|0.712
72429264|NCT03615482|144369538|NON_INFERIORITY|Non-inferiority is based on the lower bound of the 95% confidence interval (CI) on the estimated GMT ratio (Concomitant Group/Nonconcomitant Group) being \>0.5 (one-sided p-value \< 0.025).|GMT Ratio|1.02|||<|0.001|TWO_SIDED|95.0|0.89|1.17|||cLDA|GMT ratio, 95% CI and p-value were estimated from a cLDA model.||Serotype 19F||1.17|0.89|<0.001
72354747|NCT02365649|144227509|SUPERIORITY||LS Mean of Difference|-2.3||||0.465|TWO_SIDED|95.0|-8.41|3.9||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Clinical non-responders, Week 20||3.90|-8.41|0.465
72354748|NCT02365649|144227509|SUPERIORITY||LS Mean of Difference|0.3||||0.924|TWO_SIDED|95.0|-6.83|7.52||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Clinical non-responders, Week 20||7.52|-6.83|0.924
72354749|NCT02365649|144227509|SUPERIORITY||LS Mean of Difference|0.4||||0.938|TWO_SIDED|95.0|-8.88|9.6||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Clinical non-responders, Week 28||9.60|-8.88|0.938
72354750|NCT02365649|144227509|SUPERIORITY||LS Mean of Difference|2.2||||0.41|TWO_SIDED|95.0|-3.17|7.64||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Clinical non-responders, Week 28||7.64|-3.17|0.410
72354751|NCT02365649|144227509|SUPERIORITY||LS Mean of Difference|0.2||||0.941|TWO_SIDED|95.0|-5.89|6.35||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Clinical non-responders, Week 28||6.35|-5.89|0.941
72354752|NCT02365649|144227509|SUPERIORITY||LS Mean of Difference|0.7||||0.872|TWO_SIDED|95.0|-8.23|9.67||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Clinical non-responders, Week 36||9.67|-8.23|0.872
72429265|NCT03615482|144369538|NON_INFERIORITY|Non-inferiority is based on the lower bound of the 95% confidence interval (CI) on the estimated GMT ratio (Concomitant Group/Nonconcomitant Group) being \>0.5 (one-sided p-value \< 0.025).|GMT Ratio|0.77|||<|0.001|TWO_SIDED|95.0|0.64|0.91|||cLDA|GMT ratio, 95% CI and p-value were estimated from a cLDA model.||Serotype 22F||0.91|0.64|<0.001
72354753|NCT02365649|144227509|SUPERIORITY||LS Mean of Difference|-1.0||||0.692|TWO_SIDED|95.0|-6.27|4.2||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Clinical non-responders, Week 36||4.20|-6.27|0.692
72354754|NCT02365649|144227509|SUPERIORITY||LS Mean of Difference|-0.4||||0.896|TWO_SIDED|95.0|-6.32|5.54||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Clinical non-responders, Week 36||5.54|-6.32|0.896
72354755|NCT02365649|144227509|SUPERIORITY||LS Mean of Difference|1.0||||0.826|TWO_SIDED|95.0|-7.92|9.87||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Clinical non-responders, Week 44||9.87|-7.92|0.826
72354756|NCT02365649|144227509|SUPERIORITY||LS Mean of Difference|0.4||||0.885|TWO_SIDED|95.0|-4.82|5.58||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Clinical non-responders, Week 44||5.58|-4.82|0.885
72354757|NCT02365649|144227509|SUPERIORITY||LS Mean of Difference|-0.1||||0.964|TWO_SIDED|95.0|-6.03|5.76||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Clinical non-responders, Week 44||5.76|-6.03|0.964
72354758|NCT02365649|144227509|SUPERIORITY||LS Mean of Difference|1.1||||0.806|TWO_SIDED|95.0|-7.59|9.72||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Clinical non-responders, Week 52||9.72|-7.59|0.806
72354759|NCT02365649|144227509|SUPERIORITY||LS Mean of Difference|0.4||||0.871|TWO_SIDED|95.0|-4.65|5.47||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Clinical non-responders, Week 52||5.47|-4.65|0.871
72354760|NCT02365649|144227509|SUPERIORITY||LS Mean of Difference|-0.5||||0.85|TWO_SIDED|95.0|-6.28|5.19||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Clinical non-responders, Week 52||5.19|-6.28|0.850
72354761|NCT02365649|144227510|SUPERIORITY||LS Mean of Difference|-3.9||||0.792|TWO_SIDED|95.0|-33.73|25.9||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Responders||25.90|-33.73|0.792
72354762|NCT02365649|144227510|SUPERIORITY||LS Mean of Difference|18.1||||0.179|TWO_SIDED|95.0|-8.62|44.75||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Responders||44.75|-8.62|0.179
72429266|NCT03615482|144369538|NON_INFERIORITY|Non-inferiority is based on the lower bound of the 95% confidence interval (CI) on the estimated GMT ratio (Concomitant Group/Nonconcomitant Group) being \>0.5 (one-sided p-value \< 0.025).|GMT Ratio|0.85|||<|0.001|TWO_SIDED|95.0|0.7|1.03|||cLDA|GMT ratio, 95% CI and p-value were estimated from a cLDA model.||Serotype 23F||1.03|0.70|<0.001
72429267|NCT03615482|144369538|NON_INFERIORITY|Non-inferiority is based on the lower bound of the 95% confidence interval (CI) on the estimated GMT ratio (Concomitant Group/Nonconcomitant Group) being \>0.5 (one-sided p-value \< 0.025).|GMT Ratio|0.83|||<|0.001|TWO_SIDED|95.0|0.72|0.96|||cLDA|GMT ratio, 95% CI and p-value were estimated from a cLDA model.||Serotype 33F||0.96|0.72|<0.001
72429268|NCT03615482|144369539|NON_INFERIORITY|Non-inferiority is based on the lower bound of the 95% confidence interval (CI) on the estimated GMT ratio (Concomitant Group/Nonconcomitant Group) being \>0.5 (one-sided p-value \< 0.025).|GMT Ratio|1.09|||<|0.001|TWO_SIDED|95.0|0.94|1.25|||cLDA|GMT ratio, 95% CI and p-value were estimated from a cLDA model.||H1N1||1.25|0.94|<0.001
72354763|NCT02365649|144227510|SUPERIORITY||LS Mean of Difference|-19.1||||0.23|TWO_SIDED|95.0|-50.87|12.63||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Responders||12.63|-50.87|0.230
72354764|NCT02365649|144227510|SUPERIORITY||LS Mean of Difference|16.4||||0.337|TWO_SIDED|95.0|-17.54|50.4||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Non-responders||50.40|-17.54|0.337
72354765|NCT02365649|144227510|SUPERIORITY||LS Mean of Difference|1.1||||0.924|TWO_SIDED|95.0|-21.75|23.93||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Non-responders||23.93|-21.75|0.924
72354766|NCT02365649|144227510|SUPERIORITY||LS Mean of Difference|-11.7||||0.373|TWO_SIDED|95.0|-37.69|14.35||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Non-responders||14.35|-37.69|0.373
72354767|NCT02365649|144227510|SUPERIORITY||LS Mean of Difference|-3.1||||0.813|TWO_SIDED|95.0|-28.94|22.79||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Clinical responders||22.79|-28.94|0.813
72354768|NCT02365649|144227510|SUPERIORITY||LS Mean of Difference|5.3||||0.651|TWO_SIDED|95.0|-18.02|28.65||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Clinical responders||28.65|-18.02|0.651
72354769|NCT02365649|144227510|SUPERIORITY||LS Mean of Difference|-23.8||||0.065|TWO_SIDED|95.0|-49.12|1.49||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|Prespecified statistically significant at 0.1 level.||Clinical responders||1.49|-49.12|0.065
72354770|NCT02365649|144227510|SUPERIORITY||LS Mean of Difference|5.3||||0.802|TWO_SIDED|95.0|-37.61|48.28||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Clinical non-responders||48.28|-37.61|0.802
72354771|NCT02365649|144227510|SUPERIORITY||LS Mean of Difference|0.6||||0.955|TWO_SIDED|95.0|-20.46|21.63||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Clinical non-responders||21.63|-20.46|0.955
72354772|NCT02365649|144227510|SUPERIORITY||LS Mean of Difference|-10.6||||0.395|TWO_SIDED|95.0|-35.73|14.47||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Clinical non-responders||14.47|-35.73|0.395
72354773|NCT02365649|144227511|SUPERIORITY||LS Mean of Difference|-0.0082||||0.893|TWO_SIDED|95.0|-0.1299|0.1136||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Responders||0.1136|-0.1299|0.893
72354774|NCT02365649|144227511|SUPERIORITY||LS Mean of Difference|0.0685||||0.182|TWO_SIDED|95.0|-0.0334|0.1705||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Responders||0.1705|-0.0334|0.182
72354775|NCT02365649|144227511|SUPERIORITY||LS Mean of Difference|-0.1323||||0.036|TWO_SIDED|95.0|-0.2552|-0.0093||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|Prespecified statistically significant at 0.05 level.||Responders||-0.0093|-0.2552|0.036
72354776|NCT02365649|144227511|SUPERIORITY||LS Mean of Difference|0.0768||||0.316|TWO_SIDED|95.0|-0.0749|0.2286||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Non-responders||0.2286|-0.0749|0.316
72354777|NCT02365649|144227511|SUPERIORITY||LS Mean of Difference|0.0573||||0.277|TWO_SIDED|95.0|-0.0471|0.1617||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Non-responders||0.1617|-0.0471|0.277
72354778|NCT02365649|144227511|SUPERIORITY||LS Mean of Difference|0.0428||||0.467|TWO_SIDED|95.0|-0.0741|0.1597||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Non-responders||0.1597|-0.0741|0.467
72354779|NCT02365649|144227511|SUPERIORITY||LS Mean of Difference|-0.036||||0.464|TWO_SIDED|95.0|-0.1336|0.0616||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Clinical responders||0.0616|-0.1336|0.464
72354780|NCT02365649|144227511|SUPERIORITY||LS Mean of Difference|0.0404||||0.345|TWO_SIDED|95.0|-0.0444|0.1252||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Clinical responders||0.1252|-0.0444|0.345
72354781|NCT02365649|144227511|SUPERIORITY||LS Mean of Difference|-0.0873||||0.071|TWO_SIDED|95.0|-0.1822|0.0076||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|Prespecified statistically significant at 0.1 level.||Clinical responders||0.0076|-0.1822|0.071
72354782|NCT02365649|144227511|SUPERIORITY||LS Mean of Difference|0.1109||||0.317|TWO_SIDED|95.0|-0.1109|0.3326||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Clinical non-responders||0.3326|-0.1109|0.317
72354783|NCT02365649|144227511|SUPERIORITY||LS Mean of Difference|0.0848||||0.125|TWO_SIDED|95.0|-0.0248|0.1945||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Clinical non-responders||0.1945|-0.0248|0.125
72354784|NCT02365649|144227511|SUPERIORITY||LS Mean of Difference|0.0559||||0.39|TWO_SIDED|95.0|-0.0745|0.1864||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Clinical non-responders||0.1864|-0.0745|0.390
72354785|NCT02365649|144227512|SUPERIORITY||LS Mean of Difference|8.7||||0.263|TWO_SIDED|95.0|-6.79|24.16||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Responders||24.16|-6.79|0.263
72354786|NCT02365649|144227512|SUPERIORITY||LS Mean of Difference|15.2||||0.031|TWO_SIDED|95.0|1.47|28.93||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|Prespecified statistically significant at 0.05 level.||Responders||28.93|1.47|0.031
72354787|NCT02365649|144227512|SUPERIORITY||LS Mean of Difference|-12.0||||0.135|TWO_SIDED|95.0|-27.93|3.9||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Responders||3.90|-27.93|0.135
72354788|NCT02365649|144227512|SUPERIORITY||LS Mean of Difference|6.3||||0.458|TWO_SIDED|95.0|-10.61|23.27||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Non-responders||23.27|-10.61|0.458
72354789|NCT02365649|144227512|SUPERIORITY||LS Mean of Difference|1.9||||0.738|TWO_SIDED|95.0|-9.59|13.45||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Non-responders||13.45|-9.59|0.738
72354790|NCT02365649|144227512|SUPERIORITY||LS Mean of Difference|-5.4||||0.412|TWO_SIDED|95.0|-18.32|7.6||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Non-responders||7.60|-18.32|0.412
72354791|NCT02365649|144227512|SUPERIORITY||LS Mean of Difference|3.9||||0.534|TWO_SIDED|95.0|-8.56|16.36||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Clinical responders||16.36|-8.56|0.534
72354792|NCT02365649|144227512|SUPERIORITY||LS Mean of Difference|11.0||||0.052|TWO_SIDED|95.0|-0.1|22.01||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|Prespecified statistically significant at 0.1 level.||Clinical responders||22.01|-0.10|0.052
72354793|NCT02365649|144227512|SUPERIORITY||LS Mean of Difference|-13.9||||0.027|TWO_SIDED|95.0|-26.15|-1.63||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|Prespecified statistically significant at 0.05 level.||Clinical responders||-1.63|-26.15|0.027
72354794|NCT02365649|144227512|SUPERIORITY||LS Mean of Difference|-1.0||||0.928|TWO_SIDED|95.0|-24.02|21.97||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Clinical non-responders||21.97|-24.02|0.928
72354795|NCT02365649|144227512|SUPERIORITY||LS Mean of Difference|-2.5||||0.658|TWO_SIDED|95.0|-13.72|8.77||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Clinical non-responders||8.77|-13.72|0.658
72354796|NCT02365649|144227512|SUPERIORITY||LS Mean of Difference|-3.5||||0.601|TWO_SIDED|95.0|-16.96|9.96||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Clinical non-responders||9.96|-16.96|0.601
72354797|NCT02365649|144227514|SUPERIORITY||Risk Difference (RD)|-50.0||||1|TWO_SIDED|95.0|-99.0|-1.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders||-1.0|-99.0|1.000
72354798|NCT02365649|144227514|SUPERIORITY||Risk Difference (RD)|-25.0||||1|TWO_SIDED|95.0|-55.0|5.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical Responders||5.0|-55.0|1.000
72354799|NCT02365649|144227514|SUPERIORITY||Risk Difference (RD)|-25.0||||1|TWO_SIDED|95.0|-55.0|5.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical Responders||5.0|-55.0|1.000
72354800|NCT02365649|144227514|SUPERIORITY||Risk Difference (RD)|-25.0||||1|TWO_SIDED|95.0|-55.0|5.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical Responders||5.0|-55.0|1.000
72354801|NCT02365649|144227515|SUPERIORITY||Risk Difference (RD)|-66.7||||1|TWO_SIDED|95.0|-100.0|-13.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders||-13.3|-100.0|1.000
72429269|NCT03615482|144369539|NON_INFERIORITY|Non-inferiority is based on the lower bound of the 95% confidence interval (CI) on the estimated GMT ratio (Concomitant Group/Nonconcomitant Group) being \>0.5 (one-sided p-value \< 0.025).|GMT Ratio|1.03|||<|0.001|TWO_SIDED|95.0|0.9|1.17|||cLDA|GMT ratio, 95% CI and p-value were estimated from a cLDA model.||H3N2||1.17|0.90|<0.001
72429270|NCT03615482|144369539|NON_INFERIORITY|Non-inferiority is based on the lower bound of the 95% confidence interval (CI) on the estimated GMT ratio (Concomitant Group/Nonconcomitant Group) being \>0.5 (one-sided p-value \< 0.025).|GMT Ratio|0.96|||<|0.001|TWO_SIDED|95.0|0.86|1.08|||cLDA|GMT ratio, 95% CI and p-value were estimated from a cLDA model.||B-Victoria||1.08|0.86|<0.001
72429271|NCT03615482|144369539|NON_INFERIORITY|Non-inferiority is based on the lower bound of the 95% confidence interval (CI) on the estimated GMT ratio (Concomitant Group/Nonconcomitant Group) being \>0.5 (one-sided p-value \< 0.025).|GMT Ratio|1.01|||<|0.001|TWO_SIDED|95.0|0.9|1.13|||cLDA|GMT ratio, 95% CI and p-value were estimated from a cLDA model.||B-Yamagata||1.13|0.90|<0.001
72354802|NCT02365649|144227515|SUPERIORITY||Risk Difference (RD)|33.3||||0.25|TWO_SIDED|95.0|-20.0|86.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders||86.7|-20.0|0.250
72354803|NCT02365649|144227515|SUPERIORITY||Risk Difference (RD)|16.7||||1|TWO_SIDED|95.0|-62.2|95.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders||95.6|-62.2|1.000
72354804|NCT02365649|144227515|SUPERIORITY||Risk Difference (RD)|-33.3||||0.5|TWO_SIDED|95.0|-71.1|4.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders||4.4|-71.1|0.500
72354805|NCT02365649|144227515|SUPERIORITY||Risk Difference (RD)|-33.3||||1|TWO_SIDED|95.0|-71.1|4.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders||4.4|-71.1|1.000
72354806|NCT00965250|144227564|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Kaplan Meier|||||||<0.0001
72354807|NCT00965250|144227565|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Kaplan Meier|||||||<0.0001
72354808|NCT00479713|144227605|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-10.72|STANDARD_ERROR_OF_MEAN|1.72|<=|0.001||95.0|-14.1|-7.33|||ANOVA|Model terms: treatment, stratum, baseline (categorized based on quartiles) and center||||-7.33|-14.10|<=0.001
72354809|NCT00479713|144227606|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.1|||<=|0.001||95.0|1.5|3.0|||Regression, Logistic|Model terms: treatment, stratum and baseline LDL-C (continuous)||Percentage of Participants who Attained Target LDL-C Goal of \< 100 mg/dL (2.59 mmol/L)||3.0|1.5|<=0.001
72354810|NCT00479713|144227606|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.8|||<=|0.001||95.0|1.8|4.4|||Regression, Logistic|Model terms: treatment, stratum and baseline LDL-C (continuous)||Percentage of Participants who Attained Target LDL-C Goal of \< 70 mg/dL (1.81 mmol/L)||4.4|1.8|<=0.001
72354811|NCT00479713|144227607|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-7.2|STANDARD_ERROR_OF_MEAN|1.2|<=|0.001||95.0|-9.56|-4.84|||ANOVA|Model terms: treatment, stratum, baseline (categorized based on quartiles) and center||||-4.84|-9.56|<=0.001
72354812|NCT00479713|144227608|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-5.06||||0.056||95.0|-9.56|-0.3|||Nonparametric ANOVA|ANOVA model based on Tukey's normalized ranks with term for treatment, stratum, baseline (categorized based on quartiles) and center.|The median difference between treatments is based on the Hodges-Lehmann estimates of shift with a corresponding distribution-free Confidence Interval (CI) based on Wilcoxon's rank.|||-0.30|-9.56|0.056
72354813|NCT00479713|144227609|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.92|STANDARD_ERROR_OF_MEAN|1.17||0.433||95.0|-3.21|1.38|||ANOVA|Model terms: treatment, stratum, baseline (categorized based on quartiles) and center.||||1.38|-3.21|0.433
72354814|NCT00479713|144227610|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-9.41|STANDARD_ERROR_OF_MEAN|1.58|<=|0.001||95.0|-12.5|-6.31|||ANOVA|Model terms: treatment, stratum, baseline (categorized based on quartiles) and center.||||-6.31|-12.50|<=0.001
72354815|NCT00479713|144227611|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-9.59|STANDARD_ERROR_OF_MEAN|1.98|<=|0.001||95.0|-13.49|-5.69|||ANOVA|Model terms: treatment, stratum, baseline (categorized based on quartiles) and center.||||-5.69|-13.49|<=0.001
72354816|NCT00479713|144227612|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.25|STANDARD_ERROR_OF_MEAN|1.44|<=|0.001||95.0|-9.07|-3.43|||ANOVA|Model terms: treatment, stratum, baseline (categorized based on quartiles) and center.||||-3.43|-9.07|<=0.001
72354817|NCT00479713|144227613|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-8.11|STANDARD_ERROR_OF_MEAN|1.43|<=|0.001||95.0|-10.91|-5.3|||ANOVA|Model terms: treatment, stratum, baseline (categorized based on quartiles) and center||||-5.30|-10.91|<=0.001
72354818|NCT00479713|144227614|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.67||||0.172||95.0|-16.67|2.87|||Nonparametric ANOVA|ANOVA model based on Tukey's normalized ranks with term for treatment, stratum, baseline (categorized based on quartiles) and center|The median difference between treatments is based on the Hodges-Lehmann estimates of shift with a corresponding distribution-free CI based on Wilcoxon's rank|||2.87|-16.67|0.172
72354819|NCT00141102|144227615|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|4.32|||<|0.0001|TWO_SIDED||||||Life Table Extension|Stratified by history of GD ulceration and by region.||||||<0.0001
72354820|NCT00141102|144227616|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|3.93|||<|0.0001|TWO_SIDED||||||Life Table Extension|Stratified by history of GD ulceration and by region.||||||<0.0001
72429272|NCT03615482|144369540|OTHER|GMC ratio and 95% CI were estimated from cLDA model.|GMC Ratio|0.77|||||TWO_SIDED|95.0|0.67|0.89||||||Serotype 1||0.89|0.67|
72429273|NCT03615482|144369540|OTHER|GMC ratio and 95% CI were estimated from cLDA model.|GMC Ratio|0.87|||||TWO_SIDED|95.0|0.76|0.99||||||Serotype 3||0.99|0.76|
72354821|NCT00141102|144227617|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) Mean Difference|-0.019|STANDARD_ERROR_OF_MEAN|0.023||0.4146|TWO_SIDED|95.0|-0.06|0.03|||ANCOVA|Fixed effects of region and history of GD ulceration with Baseline covariate.||||0.03|-0.06|0.4146
72354822|NCT00141102|144227618|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.29||||0.1132|TWO_SIDED||||||Life Table Extension|Stratified by history of GD ulceration and by region.||||||0.1132
72354823|NCT00141102|144227620|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.26||||0.0495|TWO_SIDED||||||Life Table Extension|Stratified by history of GD ulceration and by region.||||||0.0495
72354824|NCT00141102|144227621|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.52||||0.0006|TWO_SIDED||||||Life Table Extension|Stratified by history of GD ulceration and by region.||||||0.0006
72354825|NCT00141102|144227622|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.406|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001|TWO_SIDED|95.0|0.36|0.45|||ANCOVA|Fixed effects of region and history of GD ulceration with Baseline covariate.||||0.45|0.36|<0.0001
72354826|NCT00141102|144227623|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|1.118|STANDARD_ERROR_OF_MEAN|0.069|<|0.0001|TWO_SIDED|95.0|0.98|1.25|||ANCOVA|Fixed effects of region and history of GD ulceration with Baseline covariate.||||1.25|0.98|<0.0001
72354827|NCT00141102|144227624|SUPERIORITY_OR_OTHER_LEGACY||Relative Risk|2.748|||<|0.0001|TWO_SIDED|95.0|1.96|3.84|||Cochran-Mantel-Haenszel|Stratified by history of GD ulceration and by region.||||3.84|1.96|<0.0001
72354828|NCT00141102|144227625|SUPERIORITY_OR_OTHER_LEGACY||Relative Risk|3.329|||<|0.0001|TWO_SIDED|95.0|2.156|5.141|||Fisher Exact|||GGT||5.141|2.156|<0.0001
72354829|NCT00141102|144227625|SUPERIORITY_OR_OTHER_LEGACY||Relative Risk|1.509||||0.3809|TWO_SIDED|95.0|0.618|3.684|||Fisher Exact|||AST||3.684|0.618|0.3809
72354830|NCT00141102|144227625|SUPERIORITY_OR_OTHER_LEGACY||Relative Risk|2.089||||0.0264|TWO_SIDED|95.0|1.081|4.038|||Fisher Exact|||ALT||4.038|1.081|0.0264
72354831|NCT00141102|144227626|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-10.144|STANDARD_ERROR_OF_MEAN|0.697|<|0.0001|TWO_SIDED|95.0|-11.51|-8.78|||ANCOVA|||GGT||-8.78|-11.51|<0.0001
72354832|NCT00141102|144227626|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-2.391|STANDARD_ERROR_OF_MEAN|0.281|<|0.0001|TWO_SIDED|95.0|-2.94|-1.84|||ANCOVA|||AST||-1.84|-2.94|<0.0001
72354833|NCT00141102|144227626|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-6.364|STANDARD_ERROR_OF_MEAN|0.428|<|0.0001|TWO_SIDED|95.0|-7.2|-5.52|||ANCOVA|||ALT||-5.52|-7.20|<0.0001
72354834|NCT00141102|144227627|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.565|STANDARD_ERROR_OF_MEAN|1.366||0.6795|TWO_SIDED|95.0|-2.11|3.24|||ANCOVA|Fixed effects of region and history of GD ulceration with Baseline covariate.||||3.24|-2.11|0.6795
72354835|NCT00141102|144227628|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.406|STANDARD_ERROR_OF_MEAN|2.624||0.592|TWO_SIDED|95.0|-6.55|3.74|||ANCOVA|Fixed effects of region and history of GD ulceration with Baseline covariate.||||3.74|-6.55|0.5920
72354836|NCT00141102|144227629|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.015|STANDARD_ERROR_OF_MEAN|0.038||0.6819|TWO_SIDED|95.0|-0.09|0.06|||ANCOVA|Fixed effects of region and history of GD ulceration with Baseline covariate.||||0.06|-0.09|0.6819
72354837|NCT03863509|144227632|OTHER|||||||0.494|||||||ANCOVA|Age, sex, and race/ethnicity were covaried. Test for group difference: F (2, 384) = 0.707, p = .494||||||.494
72354838|NCT03863509|144227633|OTHER|||||||0.001|||||||ANCOVA|Age, sex, and race/ethnicity were covaried. Test for group difference F(2, 381) = 7.409, p = .001||||||0.001
72354839|NCT03863509|144227633|OTHER||Mean Difference (Final Values)|-0.42||||0.822|TWO_SIDED|95.0|-4.08|3.24|||ANCOVA post-hoc pairwise group compariso|Age, sex, and race/ethnicity were covaried.||these are pairwise follow-up tests probing a larger omnibus group difference involving three groups.||3.240|-4.080|0.822
72354840|NCT03863509|144227633|OTHER||Mean Difference (Final Values)|7.267||||0.001|TWO_SIDED|95.0|2.974|11.559|||ANCOVA post-hoc pairwise group compariso|Age, sex, and race were covaried||these are pairwise follow-up tests probing a larger omnibus group difference involving three groups.||11.559|2.974|0.001
72354841|NCT03863509|144227633|OTHER||Mean Difference (Final Values)|7.687|||<|0.001|TWO_SIDED|95.0|3.485|11.889|||ANCOVA post-hoc pairwise group compariso|Age, sex and race were covaried||These are pairwise follow-up tests probing a larger omnibus group difference involving three groups.||11.889|3.485|<0.001
72354842|NCT03863509|144227634|OTHER|||||||0.074||||||Age, sex, and race/ethnicity were covaried. Test for group difference: F (2, 386) = 2.616, p = .074|ANCOVA|||||||.074
72354843|NCT03863509|144227635|OTHER||Type III F-test of Fixed Group x Time ef|6.609||||0.002|TWO_SIDED|||||False Discovery Rate correction (Benjamini and Hochberg procedure) applied to a set of 13 Group x Time interaction tests.|Mixed Models Analysis|Omnibus Group x Time (pre-post) interaction test: F (2, 378.467) = 6.609, p = .002. Age, race, and sex were covaried.|F (2, 378.467) = 6.609, p = .002|Linear mixed models adjusted for age, sex, race/ethnicity compared the within-and between-group responses following product use||||.002
72354844|NCT03863509|144227635|OTHER||interaction estimate|3.3|STANDARD_ERROR_OF_MEAN|0.99||0.001|TWO_SIDED|95.0|1.36|5.24|||Mixed Models Analysis||fixed effects from linear mixed model testing for effects of group, time, and group x time in systolic blood pressure, adjusting for age, sex, and race. Here presented the Exclusive E-cigarette users x Time vs never users x time as reference|Fixed effects from mixed models of measures before and after nicotine-containing product challenge (covariate-adjusted)||5.24|1.36|0.001
72354845|NCT03863509|144227635|OTHER||interaction term estimate|3.29|STANDARD_ERROR_OF_MEAN|1.06||0.002|TWO_SIDED|95.0|1.2|5.38|||Mixed Models Analysis||fixed effects from linear mixed model testing for effects of group, time, and group x time in systolic blood pressure, adjusting for age, sex, and race. Here presented the Exclusive cigarette smokers x Time vs never users x time as reference|||5.38|1.20|0.002
72354846|NCT03863509|144227635|OTHER||Mean Difference (Final Values)|0.09|STANDARD_ERROR_OF_MEAN|0.948||0.992|TWO_SIDED||||||ANCOVA|||||||.992
72354847|NCT03863509|144227636|OTHER||Type III F-test of Fixed Group x Time ef|5.843||||0.003|TWO_SIDED|||||False Discovery Rate correction (Benjamini and Hochberg procedure) applied to a set of 13 Group x Time interaction tests.|Mixed Models Analysis|Age, race, and sex were covaried. Omnibus Group x Time (pre-post) interaction test: F (2, 378.999) = 5.843, p = .003|F (2, 378.999) = 5.843, p = .003|Linear mixed models adjusted for age, sex, race/ethnicity compared the within-and between-group responses following product use||||0.003
72354848|NCT03863509|144227636|OTHER||Interaction term Coefficient|0.03|STANDARD_ERROR_OF_MEAN|0.01||0.002|TWO_SIDED|95.0|0.01|0.05|||Mixed Models Analysis||fixed effects from linear mixed model testing for effects of group, time, and group x time in diastolic blood pressure, adjusting for age, sex, and race. Here presented the Exclusive E-cigarette users x Time vs never users x time as reference|Fixed effects from mixed models of measures before and after nicotine-containing product challenge (covariate-adjusted)||0.05|0.01|.002
72354849|NCT03863509|144227636|OTHER||Interaction term Coefficient|0.03|STANDARD_ERROR_OF_MEAN|0.01||0.003|TWO_SIDED|95.0|0.01|0.05|||Mixed Models Analysis||fixed effects from linear mixed model testing for effects of group, time, and group x time in diastolic blood pressure, adjusting for age, sex, and race. Here presented the Exclusive Smokers x Time vs never users x time as reference|Fixed effects from mixed models of measures before and after nicotine-containing product challenge (covariate-adjusted)||0.05|0.01|.003
72429274|NCT03615482|144369540|OTHER|GMC ratio and 95% CI were estimated from cLDA model.|GMC Ratio|0.79|||||TWO_SIDED|95.0|0.68|0.91||||||Serotype 4||0.91|0.68|
72429275|NCT03615482|144369540|OTHER|GMC ratio and 95% CI were estimated from cLDA model.|GMC Ratio|0.89|||||TWO_SIDED|95.0|0.77|1.02||||||Serotype 5||1.02|0.77|
72354850|NCT03863509|144227636|OTHER||Interaction term Coefficient|0.0|STANDARD_ERROR_OF_MEAN|0.01||0.917|TWO_SIDED||||||Mixed Models Analysis||fixed effects from re-parameterized linear mixed model testing for effects of group, time, and group x time in diastolic blood pressure, adjusting for age, sex, and race for Exclusive E-cigarette users x Time vs Exclusive Smokers x time as reference|Fixed effects from mixed models of measures before and after nicotine-containing product challenge (covariate-adjusted)||||.917
72354851|NCT03863509|144227637|OTHER||Type III F-test of Fixed Group x Time Ef|49.42|||<|0.001|TWO_SIDED|||||False Discovery Rate correction (Benjamini and Hochberg procedure) applied to a set of 13 Group x Time interaction tests.|Mixed Models Analysis|Age, race, and sex were covaried. Omnibus Group x Time (pre-post) interaction test: F (2, 376.099) = 49.420, p \< .001|F (2, 376.099) = 49.420, p \< .001|Linear mixed models adjusted for age, sex, race/ethnicity compared the within-and between-group responses following product use||||< .001
72354852|NCT03863509|144227637|OTHER||interaction term coefficient|6.06|STANDARD_ERROR_OF_MEAN|0.63|<|0.001|TWO_SIDED|95.0|4.83|7.3|||Mixed Models Analysis||fixed effects from linear mixed model testing for effects of group, time, and group x time in Heart Rate, adjusting for age, sex, and race for Exclusive E-cigarette users x Time vs never users x time as reference|Fixed effects from mixed models of measures before and after nicotine-containing product challenge (covariate-adjusted)||7.3|4.83|<0.001
72354853|NCT03863509|144227637|OTHER||interaction term coefficient|5.09|STANDARD_ERROR_OF_MEAN|0.68|<|0.001|TWO_SIDED|95.0|3.76|6.42|||Mixed Models Analysis||fixed effects from linear mixed model testing for effects of group, time, and group x time in Heart Rate, adjusting for age, sex, and race for Exclusive Smokers x Time vs never users x time as reference|||6.42|3.76|<0.001
72354854|NCT03863509|144227637|OTHER||interaction term coefficient|-0.97|STANDARD_ERROR_OF_MEAN|0.602||0.107|TWO_SIDED||||||Mixed Models Analysis||fixed effects from re-parameterized linear mixed model testing for effects of group, time, and group x time in Heart Rate, adjusting for age, sex, and race for Exclusive E-cigarette users x Time vs Exclusive Smokers x time as reference|||||0.107
72354855|NCT03863509|144227638|OTHER||Type III F-test of Fixed Group x Time Ef|6.194||||0.002|TWO_SIDED|||||False Discovery Rate correction (Benjamini and Hochberg procedure) applied to a set of 13 Group x Time interaction tests.|Mixed Models Analysis|Age, race, and sex were covaried. Omnibus Group x Time (pre-post) interaction test: F (2,372.971) = 6.194, p = .002|F (2,372.971) = 6.194, p = .002|Linear mixed models adjusted for age, sex, race/ethnicity compared the within-and between-group responses following product use.||||0.002
72354856|NCT03863509|144227638|OTHER||interaction term coefficient|-0.005|STANDARD_ERROR_OF_MEAN|0.001||0.003|TWO_SIDED|95.0|-0.01|-0.002|||Mixed Models Analysis||fixed effects from linear mixed model testing for effects of group, time, and group x time in Brachial Artery Diameter, adjusting for age, sex, and race for Exclusive E-cigarette users x Time vs never users x time as reference|Fixed effects from mixed models of measures before and after nicotine-containing product challenge (covariate-adjusted)||-0.002|-0.01|0.003
72354857|NCT03863509|144227638|OTHER||interaction term coefficient|-0.01|STANDARD_ERROR_OF_MEAN|0.002||0.001|TWO_SIDED|95.0|-0.01|-0.002|||Mixed Models Analysis||fixed effects from linear mixed model testing for effects of group, time, and group x time in Brachial Artery Diameter, adjusting for age, sex, and race for Exclusive Smokers x Time vs never users x time as reference|||-0.002|-0.01|0.001
72354858|NCT03863509|144227638|OTHER||interaction term coefficient|-0.001|STANDARD_ERROR_OF_MEAN|0.002||0.582|TWO_SIDED||||||Mixed Models Analysis||fixed effects from re-parameterized linear mixed model testing for effects of group, time, and group x time in Brachial Artery Diameter, adjusting for age, sex, and race for Exclusive E-cigarette users x Time vs Exclusive Smokers x time as reference|||||0.582
72354859|NCT03863509|144227639|OTHER||Type III F-test of Fixed Group x Time E|1.753||||0.175|TWO_SIDED|||||False Discovery Rate correction (Benjamini and Hochberg procedure) applied to a set of 13 Group x Time interaction tests|Mixed Models Analysis|Age, race, and sex were covaried.|FMD responses in e-cigarette users, cigarette users, and never-users controls after adjusting for changes in brachial artery diameter.|Linear mixed models adjusted for age, sex, race/ethnicity compared the within-and between-group responses following product use||||0.175
72354860|NCT03863509|144227639|OTHER||interaction term coefficient|0.75|STANDARD_ERROR_OF_MEAN|0.41||0.067|TWO_SIDED|95.0|-0.05|1.56|||Mixed Models Analysis||fixed effects from linear mixed model testing for effects of group, time, and group x time in Brachial Artery Flow Mediated Dilation, adjusting for age, sex, and race for Exclusive E-cigarette users x Time vs never users x time as reference|Fixed effects from mixed models of measures before and after nicotine-containing product challenge (covariate-adjusted)||1.56|-0.05|0.067
72354861|NCT03863509|144227639|OTHER||interaction term coefficient|0.33|STANDARD_ERROR_OF_MEAN|0.44||0.464|TWO_SIDED|95.0|-0.55|1.2|||Mixed Models Analysis||fixed effects from linear mixed model testing for effects of group, time, and group x time in Brachial Artery Flow Mediated Dilation, adjusting for age, sex, and race for Exclusive Smokers x Time vs never users x time as reference|||1.20|-0.55|0.464
72354862|NCT03863509|144227639|OTHER||interaction term coefficient|-0.43|STANDARD_ERROR_OF_MEAN|0.4||0.284|TWO_SIDED||||||Mixed Models Analysis||fixed effects from re-parameterized linear mixed model testing effects of group, time, and group x time in FMD, age, sex, race adjusted, for Exclusive E-cigarette users x Time vs Exclusive Smokers x time as reference|||||0.284
72354863|NCT03863509|144227640|OTHER||Type III F-test of Fixed Group x Time Ef|8.323|||<|0.001|TWO_SIDED|||||False Discovery Rate correction (Benjamini and Hochberg procedure) applied to a set of 13 Group x Time interaction tests|Mixed Models Analysis|Age, race, and sex were covaried. Omnibus Group x Time (pre-post) interaction test: F (2, 342.847) = 8.323, p = \<.001|F (2,342.847) = 8.323, p = \<.001|Linear mixed models adjusted for age, sex, race/ethnicity compared the within-and between-group responses following product use||||<0.001
72354864|NCT03863509|144227640|OTHER||interaction term coefficient|-6.55|STANDARD_ERROR_OF_MEAN|1.7|<|0.001|TWO_SIDED|95.0|-9.89|-3.2|||Mixed Models Analysis||fixed effects from linear mixed model testing for effects of group, time, and group x time in PNN50, adjusting for age, sex, and race for Exclusive E-cigarette users x Time vs never users x time as reference|Fixed effects from mixed models of measures before and after nicotine-containing product challenge (covariate-adjusted)||-3.20|-9.89|<0.001
72429276|NCT03615482|144369540|OTHER|GMC ratio and 95% CI were estimated from cLDA model.|GMC Ratio|0.73|||||TWO_SIDED|95.0|0.61|0.87||||||Serotype 6A||0.87|0.61|
72429277|NCT03615482|144369540|OTHER|GMC ratio and 95% CI were estimated from cLDA model.|GMC Ratio|0.77|||||TWO_SIDED|95.0|0.64|0.91||||||Serotype 6B||0.91|0.64|
72354865|NCT03863509|144227640|OTHER||interaction term coefficient|-6.11|STANDARD_ERROR_OF_MEAN|1.83||0.001|TWO_SIDED|95.0|-9.71|-2.52|||Mixed Models Analysis||fixed effects from linear mixed model testing for effects of group, time, and group x time in PNN50, adjusting for age, sex, and race for Exclusive Smokers x Time vs never users x time as reference|||-2.52|-9.71|0.001
72354866|NCT03863509|144227640|OTHER||interaction term coefficient|0.44|STANDARD_ERROR_OF_MEAN|1.61||0.787|TWO_SIDED||||||Mixed Models Analysis||fixed effects from re-parameterized linear mixed model testing for effects of group, time, and group x time in PNN50, adjusting for age, sex, and race for Exclusive E-cigarette users x Time vs Exclusive Smokers x time as reference|||||0.787
72354867|NCT03863509|144227641|OTHER||Type III F-test of Fixed Group x Time Ef|7.26||||0.001|TWO_SIDED|||||False Discovery Rate correction (Benjamini and Hochberg procedure) applied to a set of 13 Group x Time interaction tests|Mixed Models Analysis|Age, race, and sex were covaried. Omnibus Group x Time (pre-post) interaction test: F (2, 345.918) = 7.260, p = .001|F (2,345.918) = 7.260, p = .001|Linear mixed models adjusted for age, sex, race/ethnicity compared the within-and between-group responses following product use Outcome measure ln transformed for analysis.||||0.001
72354868|NCT03863509|144227641|OTHER||interaction term coefficient|-0.2|STANDARD_ERROR_OF_MEAN|0.06||0.001|TWO_SIDED|95.0|-0.31|-0.08|||Mixed Models Analysis||fixed effects from linear mixed model testing for effects of group, time, and group x time in RMSSD, adjusting for age, sex, and race for Exclusive E-cigarette users x Time vs never users x time as reference|Fixed effects from mixed models of measures before and after nicotine-containing product challenge (covariate-adjusted)||-0.08|-0.31|0.001
72354869|NCT03863509|144227641|OTHER||interaction term coefficient|-0.21|STANDARD_ERROR_OF_MEAN|0.06||0.001|TWO_SIDED|95.0|-0.33|-0.09|||Mixed Models Analysis||fixed effects from linear mixed model testing for effects of group, time, and group x time in RMSSD, adjusting for age, sex, and race for Exclusive Smokers x Time vs never users x time as reference|||-0.09|-0.33|0.001
72354870|NCT03863509|144227641|OTHER||interaction term coefficient|-0.01|STANDARD_ERROR_OF_MEAN|0.05||0.847|TWO_SIDED||||||Mixed Models Analysis||fixed effects from re-parameterized linear mixed model testing for effects of group, time, and group x time in RMSSD, adjusting for age, sex, and race for Exclusive E-cigarette users x Time vs Exclusive Smokers x time as reference|||||0.847
72354871|NCT03863509|144227642|OTHER||Type III F-test of Fixed Group x Time Ef|1.712||||0.182|TWO_SIDED|||||False Discovery Rate correction (Benjamini and Hochberg procedure) applied to a set of 13 Group x Time interaction tests|Mixed Models Analysis|Age, race, and sex were covaried. Omnibus Group x Time (pre-post) interaction test: F (2, 312.081) = 1.712, p = .182|F (2, 312.081) = 1.712, p = .182|Linear mixed models adjusted for age, sex, race/ethnicity compared the within-and between-group responses following product use||||.182
72354872|NCT03863509|144227642|OTHER||interaction term coefficient|-0.04|STANDARD_ERROR_OF_MEAN|0.02||0.07|TWO_SIDED|95.0|-0.09|0.004|||Mixed Models Analysis||fixed effects from linear mixed model testing for effects of group, time, and group x time in HRV-Standing Ratio, adjusting for age, sex, and race for Exclusive E-cigarette users x Time vs never users x time as reference|||0.004|-0.09|0.07
72354873|NCT03863509|144227642|OTHER||interaction term coefficient|-0.03|STANDARD_ERROR_OF_MEAN|0.03||0.196|TWO_SIDED|95.0|-0.09|0.02|||Mixed Models Analysis||fixed effects from linear mixed model testing for effects of group, time, and group x time in HRV-Standing Ratio adjusting for age, sex, and race for Exclusive Smokers x Time vs never users x time as reference|||0.02|-0.09|0.196
72354874|NCT03863509|144227642|OTHER||interaction term coefficient|0.09|STANDARD_ERROR_OF_MEAN|0.02||0.69|TWO_SIDED||||||Mixed Models Analysis||fixed effects from re-parameterized linear mixed model testing for effects of group, time, and group x time in HRV-Standing Ratio adjusting for age, sex, and race for Exclusive E-cigarette users x Time vs Exclusive Smokers x time as reference|||||0.69
72354875|NCT03863509|144227643|OTHER||Type III F-test of Fixed Group x Time Ef|4.096||||0.017|TWO_SIDED|||||False Discovery Rate correction (Benjamini and Hochberg procedure) applied to a set of 13 Group x Time interaction tests.|Mixed Models Analysis|Age, race, and sex were covaried. Omnibus Group x Time (pre-post) interaction test: F (2, 373.239) = 4.096, p = .017|F (2, 373.239) = 4.096, p = .017|Linear mixed models adjusted for age, sex, race/ethnicity compared the within-and between-group responses following product use.||||0.017
72354876|NCT03863509|144227643|OTHER||interaction term coefficient|-3.04|STANDARD_ERROR_OF_MEAN|1.09||0.005|TWO_SIDED|95.0|-5.18|-0.91|||Mixed Models Analysis||fixed effects from linear mixed model testing for effects of group, time, and group x time in FEV1, adjusting for age, sex, and race for Exclusive E-cigarette users x Time vs never users x time as reference|||-0.91|-5.18|0.005
72354877|NCT03863509|144227643|OTHER||interaction term coefficient|-1.29|STANDARD_ERROR_OF_MEAN|1.18||0.274|TWO_SIDED|95.0|-3.61|1.03|||Mixed Models Analysis||fixed effects from linear mixed model testing for effects of group, time, and group x time in FEV1, adjusting for age, sex, and race for Exclusive Smokers x Time vs never users x time as reference|||1.03|-3.61|0.274
72354878|NCT03863509|144227643|OTHER||interaction term coefficient|1.75|STANDARD_ERROR_OF_MEAN|1.06||0.098|TWO_SIDED||||||Mixed Models Analysis||fixed effects from re-parameterized linear mixed model testing for effects of group, time, and group x time in FEV1, adjusting for age, sex, and race for Exclusive E-cigarette users x Time vs Exclusive Smokers x time as reference|||||0.098
72354879|NCT03863509|144227644|OTHER||Type III F-test of Fixed Group x Time Ef|0.26||||0.771|TWO_SIDED|||||False Discovery Rate correction (Benjamini and Hochberg procedure) applied to a set of 13 Group x Time interaction tests|Mixed Models Analysis|Age, race, and sex were covaried. Omnibus Group x Time (pre-post) interaction test: F (2, 373.434) = 0.260, p = .771|F (2, 373.434) = 0.260, p = .771|Linear mixed models adjusted for age, sex, race/ethnicity compared the within-and between-group responses following product use.||||.771
72354880|NCT03863509|144227644|OTHER||interaction term coefficient|-0.12|STANDARD_ERROR_OF_MEAN|1.14||0.918|TWO_SIDED|95.0|-2.35|2.12|||Mixed Models Analysis||fixed effects from linear mixed model testing for effects of group, time, and group x time in FVC, adjusting for age, sex, and race for Exclusive E-cigarette users x Time vs never users x time as reference|Fixed effects from mixed models of measures before and after nicotine-containing product challenge (covariate-adjusted)||2.12|-2.35|0.918
72354881|NCT03863509|144227644|OTHER||interaction term coefficient|-0.8|STANDARD_ERROR_OF_MEAN|1.23||0.518|TWO_SIDED|95.0|-3.22|1.63|||Mixed Models Analysis||fixed effects from linear mixed model testing for effects of group, time, and group x time in FVC, adjusting for age, sex, and race for Exclusive Smokers x Time vs never users x time as reference|||1.63|-3.22|0.518
72354882|NCT03863509|144227644|OTHER||interaction term coefficient|-0.68|STANDARD_ERROR_OF_MEAN|1.11||0.539|TWO_SIDED||||||Mixed Models Analysis||fixed effects from re-parameterized linear mixed model testing for effects of group, time, and group x time in FVC, adjusting for age, sex, and race for Exclusive E-cigarette users x Time vs Exclusive Smokers x time as reference|||||0.539
72354883|NCT03863509|144227645|OTHER||Type III F-test of Fixed Group x Time Ef|7.157||||0.001|TWO_SIDED|||||False Discovery Rate correction (Benjamini and Hochberg procedure) applied to a set of 13 Group x Time interaction tests|Mixed Models Analysis|Age, race, and sex were covaried. Omnibus Group x Time (pre-post) interaction test: F (2, 375.412) = 7.157, p = .001|F (2, 375.412) = 7.157, p = .001|Linear mixed models adjusted for age, sex, race/ethnicity compared the within-and between-group responses following product use.||||0.001
72354884|NCT03863509|144227645|OTHER||interaction term coefficient|-3.39|STANDARD_ERROR_OF_MEAN|1.04||0.001|TWO_SIDED|95.0|-5.43|-1.35|||Mixed Models Analysis||fixed effects from linear mixed model testing for effects of group, time, and group x time in FEV1/FVC, adjusting for age, sex, and race for Exclusive E-cigarette users x Time vs never users x time as reference|||-1.35|-5.43|0.001
72354885|NCT03863509|144227645|OTHER||interaction term coefficient|-0.32|STANDARD_ERROR_OF_MEAN|1.12||0.778|TWO_SIDED|95.0|-2.53|1.89|||Mixed Models Analysis||fixed effects from linear mixed model testing for effects of group, time, and group x time in FEV1/FVC, adjusting for age, sex, and race for Exclusive Smokers x Time vs never users x time as reference|||1.89|-2.53|0.778
72354886|NCT03863509|144227645|OTHER||interaction term coefficient|3.08|STANDARD_ERROR_OF_MEAN|1.08||0.002|TWO_SIDED||||||Mixed Models Analysis||fixed effects from re-parameterized linear mixed model testing for effects of group, time, and group x time in FEV1/FVC, adjusting for age, sex, and race for Exclusive E-cigarette users x Time vs Exclusive Smokers x time as reference|||||0.002
72354887|NCT03863509|144227646|OTHER||Type III F-test of Fixed Group x Time Ef|4.317||||0.014|TWO_SIDED|||||False Discovery Rate correction (Benjamini and Hochberg procedure) applied to a set of 13 Group x Time interaction tests.|Mixed Models Analysis|Age, race, and sex were covaried. Omnibus Group x Time (pre-post) interaction test: F (2, 373.170) = 4.317, p = .014|F (2, 373.170) = 4.317, p = .014|Linear mixed models adjusted for age, sex, race/ethnicity compared the within-and between-group responses following product use||||0.014
72354888|NCT03863509|144227646|OTHER||interaction term coefficient|-5.08|STANDARD_ERROR_OF_MEAN|2.1||0.016|TWO_SIDED|95.0|-9.21|-0.95|||Mixed Models Analysis||fixed effects from linear mixed model testing for effects of group, time, and group x time in FEF 25-75, adjusting for age, sex, and race for Exclusive E-cigarette users x Time vs never users x time as reference|Fixed effects from mixed models of measures before and after nicotine-containing product challenge (covariate-adjusted)||-0.95|-9.21|0.016
72354889|NCT03863509|144227646|OTHER||interaction term coefficient|0.01|STANDARD_ERROR_OF_MEAN|2.28||0.998|TWO_SIDED|95.0|-4.47|4.48|||Mixed Models Analysis||fixed effects from linear mixed model testing for effects of group, time, and group x time in FEF 25-75, adjusting for age, sex, and race for Exclusive Smokers x Time vs never users x time as reference|||4.48|-4.47|0.998
72354890|NCT03863509|144227646|OTHER||interaction term coefficient|5.09|STANDARD_ERROR_OF_MEAN|2.04||0.013|TWO_SIDED||||||Mixed Models Analysis||fixed effects from re-parameterized linear mixed model testing for effects of group, time, and group x time in FEF 25-75, adjusting for age, sex, and race for Exclusive E-cigarette users x Time vs Exclusive Smokers x time as reference|||||0.013
72354891|NCT03863509|144227647|OTHER||Type III F-test of Fixed Group x Time Ef|6.694||||0.001|TWO_SIDED|||||False Discovery Rate correction (Benjamini and Hochberg procedure) applied to a set of 13 Group x Time interaction tests.|Mixed Models Analysis|Age, race, and sex were covaried. Omnibus Group x Time (pre-post) interaction test: F (2,376.779) = 6.694, p = .001|F ((2,376.779) = 6.694, p = .001|Linear mixed models adjusted for age, sex, race/ethnicity compared the within-and-between-group responses following product use Outcome measure ln transformed for analysis.||||0.001
72354892|NCT03863509|144227647|OTHER||interaction term coefficient|-0.09|STANDARD_ERROR_OF_MEAN|0.03||0.001|TWO_SIDED|95.0|-0.14|-0.04|||Mixed Models Analysis||fixed effects from linear mixed model testing for effects of group, time, and group x time in FeNO, adjusting for age, sex, and race for Exclusive E-cigarette users x Time vs never users x time as reference|Fixed effects from mixed models of measures before and after nicotine-containing product challenge (covariate-adjusted)||-0.04|-0.14|0.001
72354893|NCT03863509|144227647|OTHER||interaction term coefficient|-0.02|STANDARD_ERROR_OF_MEAN|0.03||0.555|TWO_SIDED|95.0|-0.08|0.04|||Mixed Models Analysis||fixed effects from linear mixed model testing for effects of group, time, and group x time in FeNO, adjusting for age, sex, and race for Exclusive Smokers x Time vs never users x time as reference|||0.04|-0.08|0.555
72354894|NCT03863509|144227647|OTHER||interaction term coefficient|0.007|STANDARD_ERROR_OF_MEAN|0.03||0.007|TWO_SIDED||||||Mixed Models Analysis||fixed effects from re-parameterized linear mixed model testing for effects of group, time, and group x time in FeNO, adjusting for age, sex, and race for Exclusive E-cigarette users x Time vs Exclusive Smokers x time as reference|||||0.007
72354895|NCT03863509|144227648|OTHER||||||<|0.001||||||ANCOVA for group differences|ANCOVA|Age, sex, and race/ethnicity were covaried. Test for group difference: F (2, 386) = 12.869, p \< .001||||||< .001
72354896|NCT03863509|144227648|OTHER||Mean Difference (Final Values)|1.352||||0.269|TWO_SIDED|95.0|-1.048|3.752|||ANCOVA post-hoc pairwise group compariso|Age, sex, and race were covaried||Never Users minus Exclusive E-Cig Users||3.752|-1.048|0.269
72354897|NCT03863509|144227648|OTHER||Mean Difference (Final Values)|-5.575|||<|0.001|TWO_SIDED|95.0|-8.37|-2.78|||ANCOVA post-hoc pairwise group compariso|Age, sex and race were covaried||Never Users minus Exclusive Smokers||-2.780|-8.37|<0.001
72354898|NCT03863509|144227648|OTHER||Mean Difference (Final Values)|-6.927|||<|0.001|TWO_SIDED|95.0|-9.672|-4.183|||ANCOVA post-hoc pairwise group compariso|Age, sex and race were covaried.||Exclusive E-Cig Users minus Exclusive Smokers||-4.183|-9.672|<0.001
72354899|NCT03863509|144227649|OTHER|||||||0.035|||||||ANCOVA|Age, sex, and race/ethnicity were covaried. Test for group difference: F (2, 361) = 3.392, p = .035|||Group difference did not survive correction for false discovery rate at .05, therefore not followed with post-hoc pairwise comparisons.|||.035
72429278|NCT03615482|144369540|OTHER|GMC ratio and 95% CI were estimated from cLDA model.|GMC Ratio|0.88|||||TWO_SIDED|95.0|0.76|1.01||||||Serotype 7F||1.01|0.76|
72429279|NCT03615482|144369540|OTHER|GMC ratio and 95% CI were estimated from cLDA model.|GMC Ratio|0.9|||||TWO_SIDED|95.0|0.79|1.03||||||Serotype 9V||1.03|0.79|
72429280|NCT03615482|144369540|OTHER|GMC ratio and 95% CI were estimated from cLDA model.|GMC Ratio|0.85|||||TWO_SIDED|95.0|0.73|0.99||||||Serotype 14||0.99|0.73|
72354900|NCT03863509|144227650|OTHER|||||||0.549|||||||ANCOVA|Age, sex, and race/ethnicity were covaried. Test for group difference: F (2, 386) = 0.601, p = .549||||||.549
72354901|NCT03863509|144227651|OTHER|||||||0.022|||||||ANCOVA|Age, sex, and race/ethnicity were covaried. Test for group difference: F (2, 381) = 3.877, p = .022|||Group difference tested after correction for false discovery rate at .05, therefore we followed with post-hoc pairwise comparisons.|||.022
72354902|NCT03863509|144227651|OTHER|||||||0.952|||||||ANCOVA post-hoc pairwise group compariso|Age, sex, and race were covaried||Never Users minus Exclusive E-Cig Users||||0.952
72354903|NCT03863509|144227651|OTHER|||||||0.014|||||||ANCOVA post-hoc pairwise group compariso|Age, sex, and race were covaried||post hoc pairwise group comparisons.. Never Users minus Exclusive Smokers||||0.014
72354904|NCT03863509|144227651|OTHER|||||||0.011||||||Age, sex, and race were covaried|ANCOVA post-hoc pairwise group compariso|||Exclusive E-Cig Users minus Exclusive Smokers||||0.011
72354905|NCT03863509|144227652|OTHER||||||<|0.001|||||||ANCOVA|Age, sex, and race/ethnicity were covaried. Outcome variable log-transformed for analysis. Test for group difference: F (2, 381) = 33.442, p \< .001|||Group difference tested for false discovery rate at .05 and followed with post-hoc pairwise comparisons.|||< .001
72354906|NCT03863509|144227652|OTHER||Mean Difference (Final Values)|0.18||||0.013|TWO_SIDED|95.0|0.039|0.322|||ANCOVA post-hoc pairwise group compariso|Age, sex, and race were covaried|Estimated marginal mean differences (log-transformed scale)|Never Users minus Exclusive E-Cig Users:||0.322|0.039|0.013
72354907|NCT03863509|144227652|OTHER||Mean Difference (Final Values)|0.679|||<|0.001|TWO_SIDED|95.0|0.514|0.844|||ANCOVA post-hoc pairwise group compariso|Age, sex and race were covaried|Estimated marginal mean differences (log-transformed scale)|Never Users minus Exclusive Smokers||0.844|0.514|<0.001
72354908|NCT03863509|144227652|OTHER||Mean Difference (Final Values)|0.498|||<|0.001|TWO_SIDED|95.0|0.336|0.66|||ANCOVA post-hoc pairwise group compariso|Age, sex, and race/ethnicity were covaried|"Estimated marginal mean differences (log-transformed scale)"|Exclusive E-Cig users minus Exclusive Smokers||0.660|0.336|<0.001
72354909|NCT03863509|144227653|OTHER|||||||0.15|||||||ANCOVA|Age, sex, and race/ethnicity were covaried. Test for group difference: F (2, 361) = 1.904, p = .150||||||.150
72354910|NCT03863509|144227654|OTHER||||||<|0.001|||||||ANCOVA|Age, sex, and race/ethnicity were covaried. Test for group difference: F (2, 385) = 17.872, p \< .001|||Group difference tested for false discovery rate at .05, and followed with post-hoc pairwise comparisons. Estimated marginal mean differences:|||< .001
72354911|NCT03863509|144227654|OTHER||Mean Difference (Final Values)|-3.632||||0.003|TWO_SIDED|95.0|-6.019|-1.245|||ANCOVA post-hoc pairwise group compariso|Age, sex, and race were covaried||Never Users minus Exclusive E-Cig Users||-1.245|-6.019|0.003
72354912|NCT03863509|144227654|OTHER||Mean Difference (Final Values)|-8.38|||<|0.001|TWO_SIDED|95.0|-11.14|-5.62|||ANCOVA post-hoc pairwise group compariso|Age, sex, and race were covaried||Never Users minus Exclusive Smokers||-5.62|-11.14|<0.001
72354913|NCT03863509|144227654|OTHER||Mean Difference (Final Values)|-4.748||||0.001|TWO_SIDED|95.0|-7.456|-2.04|||ANCOVA post-hoc pairwise group compariso|Age, sex, and race were covaried||Exclusive E-Cig Users minus Exclusive Smokers||-2.040|-7.456|0.001
72354914|NCT03863509|144227655|OTHER||||||<|0.001|||||||ANCOVA|Age, sex, and race/ethnicity were covaried. Test for group difference: F (2, 343) = 17.056, p \< .001|||Group difference tested for false discovery rate at .05, and followed with post-hoc pairwise comparisons.|||< .001
72354915|NCT03863509|144227655|OTHER||Mean Difference (Final Values)|1.279|||<|0.001|TWO_SIDED|95.0|0.733|1.824|||ANCOVA post-hoc pairwise group compariso|age, sex and race were covaried||Never Users minus Exclusive E-Cig Users||1.824|0.733|<0.001
72354916|NCT03863509|144227655|OTHER||Mean Difference (Final Values)|1.739|||<|0.001|TWO_SIDED|95.0|1.083|2.395|||ANCOVA post-hoc pairwise group compariso|Age, sex and race were covaried||Never Users minus Exclusive Smokers||2.395|1.083|<0.001
72354917|NCT03863509|144227655|OTHER||Mean Difference (Final Values)|0.46||||0.165|TWO_SIDED|95.0|-0.19|1.11|||ANCOVA post-hoc pairwise group compariso|age, sex and race were covaried||Exclusive E-Cig Users minus Exclusive Smokers||1.110|-0.190|0.165
72354918|NCT03863509|144227656|OTHER|||||||0.199|||||||ANCOVA|Age, sex, and race/ethnicity were covaried. Test for group difference: F (2, 386) = 1.621, p = .199||||||.199
72429281|NCT03615482|144369540|OTHER|GMC ratio and 95% CI were estimated from cLDA model.|GMC Ratio|0.78|||||TWO_SIDED|95.0|0.68|0.91||||||Serotype 18C||0.91|0.68|
72429282|NCT03615482|144369540|OTHER|GMC ratio and 95% CI were estimated from cLDA model.|GMC Ratio|0.89|||||TWO_SIDED|95.0|0.78|1.02||||||Serotype 19A||1.02|0.78|
72429283|NCT03615482|144369540|OTHER|GMC ratio and 95% CI were estimated from cLDA model.|GMC Ratio|0.89|||||TWO_SIDED|95.0|0.77|1.03||||||Serotype 19F||1.03|0.77|
72354919|NCT03863509|144227657|OTHER||||||<|0.001|||||||ANCOVA|Age, sex, and race/ethnicity were covaried. Test for group difference: F (2, 343) = 17.056, p\< .001|||Group difference tested for false discovery rate at .05, and followed with post-hoc pairwise comparisons.|||<0.001
72354920|NCT03863509|144227657|OTHER||Mean Difference (Final Values)|1.279|||<|0.001|TWO_SIDED|95.0|0.733|1.824|||ANCOVA post-hoc pairwise group compariso|Age, sex and race were covaried||Never Users minus Exclusive E-Cig users||1.824|0.733|<0.001
72354921|NCT03863509|144227657|OTHER||Mean Difference (Final Values)|1.739|||<|0.001|TWO_SIDED|95.0|1.083|2.395|||ANCOVA post-hoc pairwise group compariso|age, sex, race covaried||Never Users minus Exclusive Smokers||2.395|1.083|<0.001
72354922|NCT03863509|144227657|OTHER||Mean Difference (Final Values)|0.46||||0.165|TWO_SIDED|95.0|-0.19|1.11|||ANCOVA post-hoc pairwise group compariso|Age, sex and race were covaried||Exclusive E-Cig Users minus Exclusive Smokers||1.110|-0.190|0.165
72354923|NCT03863509|144227658|OTHER||||||<|0.001|||||||ANCOVA|Age, sex, and race/ethnicity were covaried. Test for group difference: F (2, 343) = 17.056, p\< .001|||Group difference tested for false discovery rate at .05, and followed with post-hoc pairwise comparisons.|||<0.001
72354924|NCT03863509|144227658|OTHER||Mean Difference (Final Values)|1.279|||<|0.001|TWO_SIDED|95.0|0.733|1.824|||ANCOVA post-hoc pairwise group compariso|Age, sex, race were covaried||Never Users minus Exclusive E-Cig Users||1.824|0.733|<0.001
72354925|NCT03863509|144227658|OTHER||Mean Difference (Final Values)|1.739|||<|0.001|TWO_SIDED|95.0|1.083|2.395|||ANCOVA post-hoc pairwise group compariso|Age, sex and race were covaried||Never Users minus Exclusive Smokers||2.395|1.083|<0.001
72354926|NCT03863509|144227658|OTHER||Mean Difference (Final Values)|0.46||||0.165|TWO_SIDED|95.0|-0.19|1.11|||ANCOVA post-hoc pairwise group compariso|Age, sex and race were covaried||Exclusive E-Cig Users minus Exclusive Smokers||1.110|-0.190|0.165
72354927|NCT03863509|144227659|OTHER||||||<|0.001|||||||ANCOVA|Age, sex, and race/ethnicity were covaried. Test for group difference: F (2, 344) = 10.075, p \< .001|||Group difference tested for false discovery rate at .05, and followed with post-hoc pairwise comparisons. Estimated marginal mean differences:|||<0.001
72368385|NCT00298558|144246922|SUPERIORITY_OR_OTHER||Effect Size|0.48|||<|0.01|TWO_SIDED|99.0|0.12|0.84|||Mixed Models Analysis|The blom transformation was used to reduce skewness in the measures. The design factors and baseline covariates were controlled in the model.|Blom transformed outcome was used and the design factors and baseline covariates were controlled in the model to get the adjusted means. After that, the effect size (defined in the Additional details) was calculated using the adjusted means and SD.|Effect size was defined as training improvement from baseline to year 10 minus control improvement from baseline to year 10 divided by the intrasubject standard deviation (SD) of the composite score. Positive effect sizes indicate improvement.||0.84|0.12|<0.01
72368386|NCT00298558|144246922|SUPERIORITY_OR_OTHER||Effect Size|0.38|||<|0.01|TWO_SIDED|99.0|0.02|0.74|||Mixed Models Analysis|The blom transformation was used to reduce skewness in the measures. The design factors and baseline covariates were controlled in the model.|Blom transformed outcome was used and the design factors and baseline covariates were controlled in the model to get the adjusted means. After that, the effect size (defined in the Additional details) was calculated using the adjusted means and SD.|Effect size was defined as training improvement from baseline to year 10 minus control improvement from baseline to year 10 divided by the intrasubject standard deviation (SD) of the composite score. Positive effect sizes indicate improvement.||0.74|0.02|<0.01
72368387|NCT00298558|144246922|SUPERIORITY_OR_OTHER||Effect Size|0.36|||<|0.01|TWO_SIDED|99.0|0.01|0.72|||Mixed Models Analysis|The blom transformation was used to reduce skewness in the measures. The design factors and baseline covariates were controlled in the model.|Blom transformed outcome was used and the design factors and baseline covariates were controlled in the model to get the adjusted means. After that, the effect size (defined in the Additional details) was calculated using the adjusted means and SD.|Effect size was defined as training improvement from baseline to year 10 minus control improvement from baseline to year 10 divided by the intrasubject standard deviation (SD) of the composite score. Positive effect sizes indicate improvement.||0.72|0.01|<0.01
72368388|NCT00298558|144246923|SUPERIORITY_OR_OTHER||Effect Size|0.004||||0.97|TWO_SIDED|99.0|-0.23|0.24|||Mixed Models Analysis|The blom transformation was used to reduce skewness in the measures. The design factors and baseline covariates were controlled in the model.|Blom transformed outcome was used and the design factors and baseline covariates were controlled in the model to get the adjusted means. After that, the effect size (defined in the Additional details) was calculated using the adjusted means and SD.|Effect size was defined as training improvement from baseline to year 10 minus control improvement from baseline to year 10 divided by the intrasubject standard deviation (SD) of the composite score. Positive effect sizes indicate improvement.||0.24|-0.23|0.97
72368389|NCT00298558|144246923|SUPERIORITY_OR_OTHER||Effect Size|-0.02||||0.86|TWO_SIDED|99.0|-0.25|0.22|||Mixed Models Analysis|The blom transformation was used to reduce skewness in the measures. The design factors and baseline covariates were controlled in the model.|Blom transformed outcome was used and the design factors and baseline covariates were controlled in the model to get the adjusted means. After that, the effect size (defined in the Additional details) was calculated using the adjusted means and SD.|Effect size was defined as training improvement from baseline to year 10 minus control improvement from baseline to year 10 divided by the intrasubject standard deviation (SD) of the composite score. Positive effect sizes indicate improvement.||0.22|-0.25|0.86
72368390|NCT00298558|144246923|SUPERIORITY_OR_OTHER||Effect Size|0.008||||0.93|TWO_SIDED|99.0|-0.23|0.24|||Mixed Models Analysis|The blom transformation was used to reduce skewness in the measures. The design factors and baseline covariates were controlled in the model.|Blom transformed outcome was used and the design factors and baseline covariates were controlled in the model to get the adjusted means. After that, the effect size (defined in the Additional details) was calculated using the adjusted means and SD.|Effect size was defined as training improvement from baseline to year 10 minus control improvement from baseline to year 10 divided by the intrasubject standard deviation (SD) of the composite score. Positive effect sizes indicate improvement.||0.24|-0.23|0.93
72368391|NCT00298558|144246924|SUPERIORITY_OR_OTHER||Effect Size|0.02||||0.78|TWO_SIDED|99.0|-0.19|0.23|||Mixed Models Analysis|The blom transformation was used to reduce skewness in the measures. The design factors and baseline covariates were controlled in the model.|Blom transformed outcome was used and the design factors and baseline covariates were controlled in the model to get the adjusted means. After that, the effect size (defined in the Additional details) was calculated using the adjusted means and SD.|Effect size was defined as training improvement from baseline to year 10 minus control improvement from baseline to year 10 divided by the intrasubject standard deviation (SD) of the composite score. Positive effect sizes indicate improvement.||0.23|-0.19|0.78
72368392|NCT00298558|144246924|SUPERIORITY_OR_OTHER||Effect Size|-0.004||||0.96|TWO_SIDED|99.0|-0.21|0.21|||Mixed Models Analysis|The blom transformation was used to reduce skewness in the measures. The design factors and baseline covariates were controlled in the model.|Blom transformed outcome was used and the design factors and baseline covariates were controlled in the model to get the adjusted means. After that, the effect size (defined in the Additional details) was calculated using the adjusted means and SD.|Effect size was defined as training improvement from baseline to year 10 minus control improvement from baseline to year 10 divided by the intrasubject standard deviation (SD) of the composite score. Positive effect sizes indicate improvement.||0.21|-0.21|0.96
72429284|NCT03615482|144369540|OTHER|GMC ratio and 95% CI were estimated from cLDA model.|GMC Ratio|0.76|||||TWO_SIDED|95.0|0.65|0.89||||||Serotype 22F||0.89|0.65|
72429285|NCT03615482|144369540|OTHER|GMC ratio and 95% CI were estimated from cLDA model.|GMC Ratio|0.83|||||TWO_SIDED|95.0|0.7|0.98||||||Serotype 23F||0.98|0.70|
72429286|NCT03615482|144369540|OTHER|GMC ratio and 95% CI were estimated from cLDA model.|GMC Ratio|0.86|||||TWO_SIDED|95.0|0.75|0.99||||||Serotype 33F||0.99|0.75|
72429287|NCT01500226|144369558|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.6|||<|0.001|TWO_SIDED|95.0|1.2|2.0||To control for multiplicity, analyses were performed hierarchically. For the CR delayed the threshold for statistical significance was 0.05; no further adjustment for multiplicity were required for the primary endpoint.|Cochran-Mantel-Haenszel|Cochran Mantel Haenszel (CMH) test was stratified by sex. Missing data were imputed as treatment failures.||||2.0|1.2|<0.001
72354928|NCT02831764|144227672|NON_INFERIORITY|Treatment with DTG+ 3TC was to be declared non-inferior to treatment with DTG+TDF/FTC if the lower end of a two-sided 95% confidence interval for the difference between the two groups in response rates at Week 48 was greater than -10%.|Adjusted difference in proportion|-0.7|||||TWO_SIDED|95.0|-4.3|2.9|||||Difference in proportion was based on CMH stratified analysis adjusting for Baseline stratification factors: Plasma HIV-1 RNA (\<= vs. \>100,000 copies per milliliter) and CD4+ cell count (\<= vs. \>200 cells per cubic millimeter \[cells/mm\^3\]).|||2.9|-4.3|
72354929|NCT02831764|144227673|NON_INFERIORITY|Treatment with DTG+ 3TC was to be declared non-inferior to treatment with DTG+TDF/FTC if the lower end of a two-sided 95% confidence interval for the difference between the two groups in response rates at Week 24 was greater than -10%.|Adjusted difference in proportion|0.1|||||TWO_SIDED|95.0|-3.4|3.6|||||Difference in proportion was based on CMH stratified analysis adjusting for Baseline stratification factors: Plasma HIV-1 RNA (\<= vs. \>100,000 c/mL) and CD4+ cell count (\<= vs. \>200 cells/mm\^3).|||3.6|-3.4|
72354930|NCT02831764|144227674|OTHER||Adjusted difference in proportion|-1.8|||||TWO_SIDED|95.0|-6.4|2.7|||||Week 96. Difference in proportion was based on CMH stratified analysis adjusting for Baseline stratification factors: Plasma HIV-1 RNA (\<= vs. \>100,000 c/mL) and CD4+ cell count (\<= vs. \>200 cells/mm\^3).|||2.7|-6.4|
72354931|NCT02831764|144227675|OTHER||Adjusted difference in proportion|0.0|||||TWO_SIDED|95.0|-5.3|5.3|||||Week 144. Difference in proportion was based on CMH stratified analysis adjusting for Baseline stratification factors: Plasma HIV-1 RNA (\<= vs. \>100,000 c/mL) and CD4+ cell count (\<= vs. \>200 cells/mm\^3).|||5.3|-5.3|
72354932|NCT02831764|144227676|OTHER||Hazard Ratio (HR)|1.02||||0.797|TWO_SIDED|95.0|0.88|1.19||The generalised Wilcoxon procedure was used to estimate a p-value for detecting a difference in cumulative incidence curves between treatment groups.|Generalised Wilcoxon procedure||Hazard ratios were estimated using the Cox proportional hazard regression model.|||1.19|0.88|0.797
72354933|NCT02831764|144227680|OTHER||Mean Difference (Net)|25.6||||0.043|TWO_SIDED|95.0|0.8|50.4|||Mixed Model Repeated Measures (MMRM)||Week 24. Following covariates/factors were adjusted: treatment, visit, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, treatment and visit interaction and Baseline CD4+ cell count and visit interaction with visit as the repeated factor.|||50.4|0.8|0.043
72354934|NCT02831764|144227680|OTHER||Mean Difference (Net)|8.5||||0.523|TWO_SIDED|95.0|-17.7|34.8|||MMRM||Week 48. Following covariates/factors were adjusted: treatment, visit, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, treatment and visit interaction and Baseline CD4+ cell count and visit interaction with visit as the repeated factor.|||34.8|-17.7|0.523
72354935|NCT02831764|144227681|OTHER||Mean Difference (Net)|7.4||||0.635|TWO_SIDED|95.0|-23.2|38.0|||Mixed Model Repeated Measures (MMRM)||Week 96. Following covariates/factors were adjusted: treatment, visit, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, treatment and visit interaction and Baseline CD4+ cell count and visit interaction with visit as the repeated factor.|||38.0|-23.2|0.635
72354936|NCT02831764|144227682|OTHER||Mean Difference (Net)|5.1||||0.777|TWO_SIDED|95.0|-29.9|40.0|||MMRM||Week 144.Following covariates/factors were adjusted: treatment, visit, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, treatment and visit interaction and Baseline CD4+ cell count and visit interaction with visit as the repeated factor.|||40.0|-29.9|0.777
72354937|NCT02831764|144227693|OTHER||Mean Difference (Net)|-0.03|||<|0.001|TWO_SIDED|95.0|-0.05|-0.02|||MMRM||Week 24. Serum Cystatin C.|||-0.02|-0.05|<0.001
72354938|NCT02831764|144227693|OTHER||Mean Difference (Net)|-0.02||||0.022|TWO_SIDED|95.0|-0.03|0.0|||MMRM||Week 48. Serum Cystatin C.|||0.00|-0.03|0.022
72354939|NCT02831764|144227693|OTHER||Mean Difference (Net)|-0.2||||0.797|TWO_SIDED|95.0|-1.4|1.1|||MMRM||Week 24. Serum RBP|||1.1|-1.4|0.797
72354940|NCT02831764|144227693|OTHER||Mean Difference (Net)|0.7||||0.258|TWO_SIDED|95.0|-0.5|1.9|||MMRM||Week 48. Serum RBP|||1.9|-0.5|0.258
72354941|NCT02831764|144227694|OTHER||Mean Difference (Net)|-0.02||||0.034|TWO_SIDED|95.0|-0.03|0.0|||MMRM||Week 96. Serum Cystatin C.|||0.00|-0.03|0.034
72354942|NCT02831764|144227695|OTHER||Mean Difference (Net)|-0.02||||0.006|TWO_SIDED|95.0|-0.04|-0.01|||MMRM||Week 144. Serum Cystatin C.|||-0.01|-0.04|0.006
72354943|NCT02831764|144227698|OTHER||Mean Difference (Net)|3.6|||<|0.001|TWO_SIDED|95.0|1.8|5.4|||MMRM||Week 24. GFR Cystatin C adjusted.|||5.4|1.8|<0.001
72354944|NCT02831764|144227698|OTHER||Mean Difference (Net)|1.7||||0.056|TWO_SIDED|95.0|0.0|3.5|||MMRM||Week 48. GFR Cystatin C adjusted.|||3.5|0.0|0.056
72354945|NCT02831764|144227698|OTHER||Mean Difference (Net)|3.4|||<|0.001|TWO_SIDED|95.0|1.7|5.2|||MMRM||Week 24. GFR creatinine adjusted.|||5.2|1.7|<0.001
72354946|NCT02831764|144227698|OTHER||Mean Difference (Net)|3.3|||<|0.001|TWO_SIDED|95.0|1.6|5.0|||MMRM||Week 48. GFR creatinine adjusted.|||5.0|1.6|<0.001
72354947|NCT02831764|144227701|OTHER||Mean Difference (Net)|-3.02|||<|0.001|TWO_SIDED|95.0|-4.49|-1.55|||MMRM||Week 24. Serum or Plasma Creatinine|||-1.55|-4.49|<0.001
72354948|NCT02831764|144227701|OTHER||Mean Difference (Net)|-3.12|||<|0.001|TWO_SIDED|95.0|-4.59|-1.65|||MMRM||Week 48. Serum or Plasma creatinine|||-1.65|-4.59|<0.001
72354949|NCT02831764|144227702|OTHER||Mean Difference (Net)|-3.04|||<|0.001|TWO_SIDED|95.0|-4.56|-1.53|||MMRM||Week 96. Serum or Plasma creatinine|||-1.53|-4.56|<0.001
72354950|NCT02831764|144227703|OTHER||Mean Difference (Net)|-2.86|||<|0.001|TWO_SIDED|95.0|-4.52|-1.19|||MMRM||Week 144. Serum or Plasma creatinine|||-1.19|-4.52|<0.001
72354951|NCT02831764|144227704|OTHER||Ratio of geometric means|0.917|||<|0.001|TWO_SIDED|95.0|0.893|0.941|||MMRM||Week 24. Serum B2M.|||0.941|0.893|<0.001
72354952|NCT02831764|144227704|OTHER||Ratio of geometric means|0.914|||<|0.001|TWO_SIDED|95.0|0.89|0.939|||MMRM||Week 48. Serum B2M.|||0.939|0.890|<0.001
72354953|NCT02831764|144227704|OTHER||Ratio of geometric means|0.748||||0.002|TWO_SIDED|95.0|0.621|0.901|||MMRM||Week 24. Urine B2M.|||0.901|0.621|0.002
72354954|NCT02831764|144227704|OTHER||Ratio of geometric means|0.693||||0.005|TWO_SIDED|95.0|0.538|0.892|||MMRM||Week 48. Urine B2M.|||0.892|0.538|0.005
72354955|NCT02831764|144227704|OTHER||Ratio of geometric means|0.889||||0.036|TWO_SIDED|95.0|0.796|0.992|||MMRM||Week 24. Urine Albumin/Creatinine.|||0.992|0.796|0.036
72354956|NCT02831764|144227704|OTHER||Ratio of geometric means|0.938||||0.308|TWO_SIDED|95.0|0.83|1.061|||MMRM||Week 48. Urine Albumin/Creatinine.|||1.061|0.830|0.308
72354957|NCT02831764|144227704|OTHER||Ratio of geometric means|0.781||||0.007|TWO_SIDED|95.0|0.654|0.934|||MMRM||Week 24. Urine B2M/Urine Creatinine.|||0.934|0.654|0.007
72354958|NCT02831764|144227704|OTHER||Ratio of geometric means|0.742||||0.012|TWO_SIDED|95.0|0.588|0.935|||MMRM||Week 48. Urine B2M/Urine Creatinine.|||0.935|0.588|0.012
72354959|NCT02831764|144227704|OTHER||Ratio of geometric means|0.979||||0.728|TWO_SIDED|95.0|0.868|1.104|||MMRM||Week 24. Urine Phosphate.|||1.104|0.868|0.728
72354960|NCT02831764|144227704|OTHER||Ratio of geometric means|1.062||||0.311|TWO_SIDED|95.0|0.945|1.194|||MMRM||Week 48. Urine Phosphate.|||1.194|0.945|0.311
72354961|NCT02831764|144227704|OTHER||Ratio of geometric means|0.826|||<|0.001|TWO_SIDED|95.0|0.769|0.887|||MMRM||Week 24. Urine Protein/Creatinine.|||0.887|0.769|<0.001
72354962|NCT02831764|144227704|OTHER||Ratio of geometric means|0.86|||<|0.001|TWO_SIDED|95.0|0.795|0.93|||MMRM||Week 48. Urine Protein/Creatinine.|||0.930|0.795|<0.001
72354963|NCT02831764|144227704|OTHER||Ratio of geometric means|0.796||||0.003|TWO_SIDED|95.0|0.683|0.927|||MMRM||Week 24. Urine RBP 4|||0.927|0.683|0.003
72354964|NCT02831764|144227704|OTHER||Ratio of geometric means|0.903||||0.2|TWO_SIDED|95.0|0.773|1.056|||MMRM||Week 48. Urine RBP 4|||1.056|0.773|0.200
72354965|NCT02831764|144227704|OTHER||Ratio of geometric means|0.826||||0.003|TWO_SIDED|95.0|0.728|0.936|||MMRM||Week 24. Urine RBP 4/Urine Creatinine|||0.936|0.728|0.003
72354966|NCT02831764|144227704|OTHER||Ratio of geometric means|0.888||||0.052|TWO_SIDED|95.0|0.787|1.001|||MMRM||Week 48. Urine RBP 4/Urine Creatinine|||1.001|0.787|0.052
72354967|NCT02831764|144227705|OTHER||Ratio of geometric means|0.942||||0.338|TWO_SIDED|95.0|0.833|1.065|||MMRM||Week 96. Urine Albumin/Creatinine.|||1.065|0.833|0.338
72354968|NCT02831764|144227705|OTHER||Ratio of geometric means|0.671|||<|0.001|TWO_SIDED|95.0|0.545|0.826|||MMRM||Week 96. Urine B2M/Urine Creatinine.|||0.826|0.545|<0.001
72354969|NCT02831764|144227705|OTHER||Ratio of geometric means|1.082||||0.174|TWO_SIDED|95.0|0.966|1.213|||MMRM||Week 96. Urine Phosphate.|||1.213|0.966|0.174
72354970|NCT02831764|144227705|OTHER||Ratio of geometric means|0.873|||<|0.001|TWO_SIDED|95.0|0.806|0.946|||MMRM||Week 96. Urine Protein/Creatinine.|||0.946|0.806|<0.001
72354971|NCT02831764|144227705|OTHER||Ratio of geometric means|0.8|||<|0.001|TWO_SIDED|95.0|0.716|0.894|||MMRM||Week 96. Urine RBP 4/Urine Creatinine|||0.894|0.716|<0.001
72354972|NCT02831764|144227706|OTHER||Ratio of geometric means|0.971||||0.658|TWO_SIDED|95.0|0.852|1.107|||MMRM||Week 144. Urine Albumin/Creatinine.|||1.107|0.852|0.658
72354973|NCT02831764|144227706|OTHER||Ratio of geometric means|0.584|||<|0.001|TWO_SIDED|95.0|0.483|0.706|||MMRM||Week 144. Urine B2M/Urine Creatinine.|||0.706|0.483|<0.001
72354974|NCT02831764|144227706|OTHER||Ratio of geometric means|1.0||||0.993|TWO_SIDED|95.0|0.892|1.12|||MMRM||Week 144. Urine Phosphate.|||1.120|0.892|0.993
72354975|NCT02831764|144227706|OTHER||Ratio of geometric means|0.847|||<|0.001|TWO_SIDED|95.0|0.785|0.913|||MMRM||Week 144. Urine Protein/Creatinine.|||0.913|0.785|<0.001
72354976|NCT02831764|144227706|OTHER||Ratio of geometric means|0.739|||<|0.001|TWO_SIDED|95.0|0.667|0.819|||MMRM||Week 144. Urine RBP 4/Urine Creatinine|||0.819|0.667|<0.001
72354977|NCT02831764|144227707|OTHER||Mean Difference (Net)|-2.66|||<|0.001|TWO_SIDED|95.0|-3.25|-2.08|||MMRM||Week 24, Bone ALP|||-2.08|-3.25|<0.001
72354978|NCT02831764|144227707|OTHER||Mean Difference (Net)|-3.09|||<|0.001|TWO_SIDED|95.0|-3.75|-2.44|||MMRM||Week 48, Bone ALP|||-2.44|-3.75|<0.001
72354979|NCT02831764|144227707|OTHER||Mean Difference (Net)|-4.67|||<|0.001|TWO_SIDED|95.0|-5.63|-3.71|||MMRM||Week 28, Serum Osteocalcin|||-3.71|-5.63|<0.001
72354980|NCT02831764|144227707|OTHER||Mean Difference (Net)|-5.9|||<|0.001|TWO_SIDED|95.0|-6.89|-4.91|||MMRM||Week 48, Serum Osteocalcin|||-4.91|-6.89|<0.001
72354981|NCT02831764|144227707|OTHER||Mean Difference (Net)|-13.5|||<|0.001|TWO_SIDED|95.0|-16.4|-10.6|||MMRM||Week 24, Serum PINP|||-10.6|-16.4|<0.001
72354982|NCT02831764|144227707|OTHER||Mean Difference (Net)|-12.8|||<|0.001|TWO_SIDED|95.0|-15.4|-10.2|||MMRM||Week 48, Serum PINP|||-10.2|-15.4|<0.001
72354983|NCT02831764|144227707|OTHER||Mean Difference (Net)|-0.127|||<|0.001|TWO_SIDED|95.0|-0.164|-0.09|||MMRM||Week 24, CTX-1|||-0.0900|-0.1640|<0.001
72354984|NCT02831764|144227707|OTHER||Mean Difference (Net)|-0.2043|||<|0.001|TWO_SIDED|95.0|-0.2532|-0.1554|||MMRM||Week 48, CTX-1|||-0.1554|-0.2532|<0.001
72354985|NCT02831764|144227708|OTHER||Mean Difference (Net)|-2.13|||<|0.001|TWO_SIDED|95.0|-2.72|-1.54|||MMRM||Week 96, Bone ALP|||-1.54|-2.72|<0.001
72354986|NCT02831764|144227708|OTHER||Mean Difference (Net)|-3.77|||<|0.001|TWO_SIDED|95.0|-4.69|-2.85|||MMRM||Week 96, Serum Osteocalcin|||-2.85|-4.69|<0.001
72354987|NCT02831764|144227708|OTHER||Mean Difference (Net)|-12.6|||<|0.001|TWO_SIDED|95.0|-16.8|-8.3|||MMRM||Week 96, Serum PINP|||-8.3|-16.8|<0.001
72354988|NCT02831764|144227708|OTHER||Mean Difference (Net)|-0.1183|||<|0.001|TWO_SIDED|95.0|-0.1529|-0.0838|||MMRM||Week 96, CTX-1|||-0.0838|-0.1529|<0.001
72354989|NCT02831764|144227709|OTHER||Mean Difference (Net)|-2.13|||<|0.001|TWO_SIDED|95.0|-2.74|-1.53|||MMRM||Week 144, Bone ALP|||-1.53|-2.74|<0.001
72354990|NCT02831764|144227709|OTHER||Mean Difference (Net)|-3.89|||<|0.001|TWO_SIDED|95.0|-4.87|-2.91|||MMRM||Week 144, Serum Osteocalcin|||-2.91|-4.87|<0.001
72354991|NCT02831764|144227709|OTHER||Mean Difference (Net)|-9.5|||<|0.001|TWO_SIDED|95.0|-12.8|-6.2|||MMRM||Week 144, Serum PINP|||-6.2|-12.8|<0.001
72354992|NCT02831764|144227709|OTHER||Mean Difference (Net)|-0.1364|||<|0.001|TWO_SIDED|95.0|-0.1739|-0.0988|||MMRM||Week 144, CTX-1|||-0.0988|-0.1739|<0.001
72354993|NCT02831764|144227710|OTHER||Mean Difference (Net)|-4.2||||0.015|TWO_SIDED|95.0|-7.5|-0.8|||MMRM||Week 24|||-0.8|-7.5|0.015
72354994|NCT02831764|144227710|OTHER||Mean Difference (Net)|-0.1||||0.96|TWO_SIDED|95.0|-2.8|2.6|||MMRM||Week 48|||2.6|-2.8|0.960
72354995|NCT02831764|144227711|OTHER||Mean Difference (Net)|-3.0||||0.048|TWO_SIDED|95.0|-5.9|0.0|||MMRM||Week 96, Serum Vitamin D|||0.0|-5.9|0.048
72354996|NCT02831764|144227712|OTHER||Mean Difference (Net)|-0.2||||0.887|TWO_SIDED|95.0|-3.6|3.1|||MMRM||Week 144, Serum Vitamin D|||3.1|-3.6|0.887
72354997|NCT02831764|144227719|OTHER||Mean Difference (Final Values)|3.5|||<|0.001|TWO_SIDED|95.0|1.5|5.6|||Fisher Exact||Week 24|||5.6|1.5|<0.001
72354998|NCT02831764|144227719|OTHER||Mean Difference (Final Values)|2.8||||0.037|TWO_SIDED|95.0|0.2|5.4|||Fisher Exact||Week 48|||5.4|0.2|0.037
72354999|NCT02831764|144227720|OTHER||Mean Difference (Final Values)|3.1||||0.045|TWO_SIDED|95.0|0.2|6.1|||Fisher Exact||Week 96|||6.1|0.2|0.045
72355000|NCT02831764|144227721|OTHER||Mean Difference (Final Values)|2.6||||0.16|TWO_SIDED|95.0|-0.8|6.0|||Fisher Exact||Week 144|||6.0|-0.8|0.160
72355001|NCT02831764|144227726|OTHER||Mean Difference (Net)|37.8|||||TWO_SIDED|95.0|9.98|65.62|||||Baseline plasma HIV-1 RNA,\<=100000. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, Baseline plasma HIV-1 RNA, and treatment and relevant Baseline plasma HIV-1 RNA interaction.|||65.62|9.98|
72355002|NCT02831764|144227726|OTHER||Mean Difference (Net)|-26.81|||||TWO_SIDED|95.0|-82.72|29.1|||||Baseline plasma HIV-1 RNA,\>100000. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, Baseline plasma HIV-1 RNA, and treatment and Baseline plasma HIV-1 RNA interaction.|||29.10|-82.72|
72355003|NCT02831764|144227726|OTHER||Mean Difference (Net)|61.72|||||TWO_SIDED|95.0|-26.94|150.39|||||Baseline CD4+ cell count,\<=200. Following covariates were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, and treatment and Baseline CD4+ cell count interaction.|||150.39|-26.94|
72355004|NCT02831764|144227726|OTHER||Mean Difference (Net)|22.57|||||TWO_SIDED|95.0|-3.42|48.55|||||Baseline CD4+ cell count,\>200. Following covariates were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, and treatment and Baseline CD4+ cell count interaction.|||48.55|-3.42|
72355005|NCT02831764|144227726|OTHER||Mean Difference (Net)|38.99|||||TWO_SIDED|95.0|5.88|72.09|||||Age Group,\<35. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, age, and treatment and age interaction.|||72.09|5.88|
72355006|NCT02831764|144227726|OTHER||Mean Difference (Net)|-9.9|||||TWO_SIDED|95.0|-53.1|33.3|||||Age Group,35 to \<50. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, age, and treatment and age interaction.|||33.30|-53.10|
72355007|NCT02831764|144227726|OTHER||Mean Difference (Net)|65.53|||||TWO_SIDED|95.0|-14.43|145.5|||||Age Group,\>=50. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, age, and treatment and age interaction.|||145.50|-14.43|
72355008|NCT02831764|144227726|OTHER||Mean Difference (Net)|59.66|||||TWO_SIDED|95.0|-8.62|127.94|||||Female. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, gender, and treatment and gender interaction.|||127.94|-8.62|
72355009|NCT02831764|144227726|OTHER||Mean Difference (Net)|19.23|||||TWO_SIDED|95.0|-7.65|46.1|||||Male. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, gender, and treatment and gender interaction.|||46.10|-7.65|
72355010|NCT02831764|144227726|OTHER||Mean Difference (Net)|19.04|||||TWO_SIDED|95.0|-11.06|49.13|||||Race group-white. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, race, and treatment and race interaction.|||49.13|-11.06|
72355011|NCT02831764|144227726|OTHER||Mean Difference (Net)|43.25|||||TWO_SIDED|95.0|-30.59|117.09|||||Race group-African Am/African H. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, race, and treatment and race interaction.|||117.09|-30.59|
72355012|NCT02831764|144227726|OTHER||Mean Difference (Net)|12.8|||||TWO_SIDED|95.0|-72.14|97.73|||||Race group-Asian. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, race, and treatment and race interaction.|||97.73|-72.14|
72355013|NCT02831764|144227726|OTHER||Mean Difference (Net)|62.01|||||TWO_SIDED|95.0|-16.09|140.12|||||Race group-Other. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, race, and treatment and race interaction.|||140.12|-16.09|
72355014|NCT02831764|144227727|OTHER||Mean Difference (Net)|6.9|||||TWO_SIDED|95.0|-22.7|36.6|||||Baseline plasma HIV-1 RNA,\<=100000. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, Baseline plasma HIV-1 RNA, and treatment and relevant Baseline plasma HIV-1 RNA interaction.|||36.6|-22.7|
72355015|NCT02831764|144227727|OTHER||Mean Difference (Net)|13.2|||||TWO_SIDED|95.0|-46.8|73.2|||||Baseline plasma HIV-1 RNA,\>100000. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, Baseline plasma HIV-1 RNA, and treatment and Baseline plasma HIV-1 RNA interaction.|||73.2|-46.8|
72355016|NCT02831764|144227727|OTHER||Mean Difference (Net)|57.7|||||TWO_SIDED|95.0|-37.2|152.5|||||Baseline CD4+ cell count,\<=200. Following covariates were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, and treatment and Baseline CD4+ cell count interaction.|||152.5|-37.2|
72355017|NCT02831764|144227727|OTHER||Mean Difference (Net)|4.1|||||TWO_SIDED|95.0|-23.5|31.7|||||Baseline CD4+ cell count,\>200. Following covariates were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, and treatment and Baseline CD4+ cell count interaction.|||31.7|-23.5|
72355018|NCT02831764|144227727|OTHER||Mean Difference (Net)|32.5|||||TWO_SIDED|95.0|-2.7|67.7|||||Age Group-1,\<35. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, age, and treatment and age interaction.|||67.7|-2.7|
72355019|NCT02831764|144227727|OTHER||Mean Difference (Net)|-31.5|||||TWO_SIDED|95.0|-77.1|14.2|||||Age Group-1,35 to \<50. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, age, and treatment and age interaction.|||14.2|-77.1|
72429288|NCT01500226|144369559|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.2||||0.143|TWO_SIDED|95.0|0.9|1.6||To control for multiplicity, analyses were performed hierarchically. CR-acute was tested only if the result for the primary endpoint, CR delayed, was statistically significant.|Cochran-Mantel-Haenszel|Cochran Mantel Haenszel (CMH) test was stratified by sex. Missing data were imputed as treatment failures.||||1.6|0.9|0.143
72355020|NCT02831764|144227727|OTHER||Mean Difference (Net)|5.2|||||TWO_SIDED|95.0|-81.4|91.8|||||Age Group-1,\>=50. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, age, and treatment and age interaction.|||91.8|-81.4|
72355021|NCT02831764|144227727|OTHER||Mean Difference (Net)|8.6|||||TWO_SIDED|95.0|-19.4|36.5|||||Age Group-2, \<50. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, age, and treatment and age interaction.|||36.5|-19.4|
72355022|NCT02831764|144227727|OTHER||Mean Difference (Net)|4.5|||||TWO_SIDED|95.0|-82.3|91.3|||||Age Group-2, \>=50. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, age, and treatment and age interaction.|||91.3|-82.3|
72355023|NCT02831764|144227727|OTHER||Mean Difference (Net)|-27.3|||||TWO_SIDED|95.0|-100.8|46.1|||||Female. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, gender, and treatment and gender interaction.|||46.1|-100.8|
72355024|NCT02831764|144227727|OTHER||Mean Difference (Net)|12.8|||||TWO_SIDED|95.0|-15.7|41.2|||||Male. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, gender, and treatment and gender interaction.|||41.2|-15.7|
72355025|NCT02831764|144227727|OTHER||Mean Difference (Net)|11.3|||||TWO_SIDED|95.0|-20.4|43.1|||||Race group-white. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, race, and treatment and race interaction.|||43.1|-20.4|
72355026|NCT02831764|144227727|OTHER||Mean Difference (Net)|-37.8|||||TWO_SIDED|95.0|-119.6|44.0|||||Race group-African Am/African H. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, race, and treatment and race interaction.|||44.0|-119.6|
72355027|NCT02831764|144227727|OTHER||Mean Difference (Net)|15.6|||||TWO_SIDED|95.0|-74.4|105.7|||||Race group-Asian. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, race, and treatment and race interaction.|||105.7|-74.4|
72355028|NCT02831764|144227727|OTHER||Mean Difference (Net)|37.6|||||TWO_SIDED|95.0|-45.4|120.5|||||Race group-Other. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, race, and treatment and race interaction.|||120.5|-45.4|
72355029|NCT02831764|144227728|OTHER||Mean Difference (Net)|0.5|||||TWO_SIDED|95.0|-34.1|35.0|||||Baseline plasma HIV-1 RNA,\<=100000. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, Baseline plasma HIV-1 RNA, and treatment and relevant Baseline plasma HIV-1 RNA interaction.|||35.0|-34.1|
72355030|NCT02831764|144227728|OTHER||Mean Difference (Net)|14.7|||||TWO_SIDED|95.0|-55.6|84.9|||||Baseline plasma HIV-1 RNA,\>100000. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, Baseline plasma HIV-1 RNA, and treatment and Baseline plasma HIV-1 RNA interaction.|||84.9|-55.6|
72355031|NCT02831764|144227728|OTHER||Mean Difference (Net)|26.5|||||TWO_SIDED|95.0|-87.3|140.3|||||Baseline CD4+ cell count,\<=200. Following covariates were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, and treatment and Baseline CD4+ cell count interaction.|||140.3|-87.3|
72355032|NCT02831764|144227728|OTHER||Mean Difference (Net)|2.8|||||TWO_SIDED|95.0|-29.4|35.1|||||Baseline CD4+ cell count,\>200. Following covariates were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, and treatment and Baseline CD4+ cell count interaction.|||35.1|-29.4|
72355033|NCT02831764|144227728|OTHER||Mean Difference (Net)|8.3|||||TWO_SIDED|95.0|-32.5|49.1|||||Age Group,\<35. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, age, and treatment and age interaction.|||49.1|-32.5|
72355034|NCT02831764|144227728|OTHER||Mean Difference (Net)|-13.3|||||TWO_SIDED|95.0|-67.6|41.1|||||Age Group,35 to \<50. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, age, and treatment and age interaction.|||41.1|-67.6|
72355035|NCT02831764|144227728|OTHER||Mean Difference (Net)|32.7|||||TWO_SIDED|95.0|-68.5|133.9|||||Age Group,\>=50. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, age, and treatment and age interaction.|||133.9|-68.5|
72355036|NCT02831764|144227728|OTHER||Mean Difference (Net)|5.1|||||TWO_SIDED|95.0|-80.7|90.8|||||Female. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, gender, and treatment and gender interaction.|||90.8|-80.7|
72355037|NCT02831764|144227728|OTHER||Mean Difference (Net)|2.1|||||TWO_SIDED|95.0|-31.1|35.3|||||Male. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, gender, and treatment and gender interaction.|||35.3|-31.1|
72355038|NCT02831764|144227728|OTHER||Mean Difference (Net)|13.7|||||TWO_SIDED|95.0|-23.2|50.6|||||Race group-white. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, race, and treatment and race interaction.|||50.6|-23.2|
72355039|NCT02831764|144227728|OTHER||Mean Difference (Net)|-57.4|||||TWO_SIDED|95.0|-155.3|40.4|||||Race group-African Am/African H. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, race, and treatment and race interaction.|||40.4|-155.3|
72355040|NCT02831764|144227728|OTHER||Mean Difference (Net)|-40.1|||||TWO_SIDED|95.0|-144.2|64.0|||||Race group-Asian. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, race, and treatment and race interaction.|||64.0|-144.2|
72355041|NCT02831764|144227728|OTHER||Mean Difference (Net)|33.1|||||TWO_SIDED|95.0|-63.3|129.6|||||Race group-Other. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, race, and treatment and race interaction.|||129.6|-63.3|
72355042|NCT02831764|144227729|OTHER||Mean Difference (Net)|9.1|||||TWO_SIDED|95.0|-31.1|49.2|||||Baseline plasma HIV-1 RNA,\<=100000. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, Baseline plasma HIV-1 RNA, and treatment and relevant Baseline plasma HIV-1 RNA interaction.|||49.2|-31.1|
72355043|NCT02831764|144227729|OTHER||Mean Difference (Net)|-16.6|||||TWO_SIDED|95.0|-98.9|65.8|||||Baseline plasma HIV-1 RNA,\>100000. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, Baseline plasma HIV-1 RNA, and treatment and Baseline plasma HIV-1 RNA interaction.|||65.8|-98.9|
72355044|NCT02831764|144227729|OTHER||Mean Difference (Net)|56.0|||||TWO_SIDED|95.0|-77.2|189.1|||||Baseline CD4+ cell count,\<=200. Following covariates were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, and treatment and Baseline CD4+ cell count interaction.|||189.1|-77.2|
72355045|NCT02831764|144227729|OTHER||Mean Difference (Net)|2.4|||||TWO_SIDED|95.0|-35.2|39.9|||||Baseline CD4+ cell count,\>200. Following covariates were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, and treatment and Baseline CD4+ cell count interaction.|||39.9|-35.2|
72355046|NCT02831764|144227729|OTHER||Mean Difference (Net)|25.8|||||TWO_SIDED|95.0|-22.3|74.0|||||Age Group,\<35. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, age, and treatment and age interaction.|||74.0|-22.3|
72355047|NCT02831764|144227729|OTHER||Mean Difference (Net)|-36.4|||||TWO_SIDED|95.0|-98.6|25.8|||||Age Group,35 to \<50. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, age, and treatment and age interaction.|||25.8|-98.6|
72355048|NCT02831764|144227729|OTHER||Mean Difference (Net)|24.1|||||TWO_SIDED|95.0|-89.0|137.2|||||Age Group,\>=50. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, age, and treatment and age interaction.|||137.2|-89.0|
72355049|NCT02831764|144227729|OTHER||Mean Difference (Net)|-26.9|||||TWO_SIDED|95.0|-125.9|72.2|||||Female. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, gender, and treatment and gender interaction.|||72.2|-125.9|
72355050|NCT02831764|144227729|OTHER||Mean Difference (Net)|8.1|||||TWO_SIDED|95.0|-30.3|46.5|||||Male. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, gender, and treatment and gender interaction.|||46.5|-30.3|
72355051|NCT02831764|144227729|OTHER||Mean Difference (Net)|3.5|||||TWO_SIDED|95.0|-39.4|46.3|||||Race group-white. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, race, and treatment and race interaction.|||46.3|-39.4|
72355052|NCT02831764|144227729|OTHER||Mean Difference (Net)|-121.2|||||TWO_SIDED|95.0|-237.2|-5.1|||||Race group-African Am/African H. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, race, and treatment and race interaction.|||-5.1|-237.2|
72355053|NCT02831764|144227729|OTHER||Mean Difference (Net)|13.1|||||TWO_SIDED|95.0|-106.4|132.6|||||Race group-Asian. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, race, and treatment and race interaction.|||132.6|-106.4|
72355054|NCT02831764|144227729|OTHER||Mean Difference (Net)|114.3|||||TWO_SIDED|95.0|4.6|224.0|||||Race group-Other. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, race, and treatment and race interaction.|||224.0|4.6|
72355055|NCT02831764|144227730|OTHER||Mean Difference (Net)|-0.0019||||0.759|TWO_SIDED|95.0|-0.0137|0.01|||MMRM||Week 4. Covariates adjusted: Treatment, Baseline plasma HIV-1 RNA , Baseline CD4+ cell count , and Baseline EQ-5D utility, treatment\*visit and Baseline EQ-5D utility\*visit as factors and covariate, with visit as the repeated factor.|||0.0100|-0.0137|0.759
72355056|NCT02831764|144227730|OTHER||Mean Difference (Net)|0.0003||||0.943|TWO_SIDED|95.0|-0.0088|0.0095|||MMRM||Week 24. Covariates adjusted: Treatment, Baseline plasma HIV-1 RNA , Baseline CD4+ cell count , and Baseline EQ-5D utility, treatment\*visit and Baseline EQ-5D utility\*visit as factors and covariate, with visit as the repeated factor.|||0.0095|-0.0088|0.943
72355057|NCT02831764|144227730|OTHER||Mean Difference (Net)|-0.0019||||0.703|TWO_SIDED|95.0|-0.0117|0.0079|||MMRM||Week 48. Covariates adjusted: Treatment, Baseline plasma HIV-1 RNA , Baseline CD4+ cell count , and Baseline EQ-5D utility, treatment\*visit and Baseline EQ-5D utility\*visit as factors and covariate, with visit as the repeated factor.|||0.0079|-0.0117|0.703
72355058|NCT02831764|144227731|OTHER||Mean Difference (Net)|-0.0003||||0.957|TWO_SIDED|95.0|-0.011|0.0104|||MMRM||Week 96. Covariates adjusted: Treatment, Baseline plasma HIV-1 RNA, Baseline CD4+ cell count, and Baseline EQ-5D utility, treatment\*visit and Baseline EQ-5D utility\*visit as factors and covariate, with visit as the repeated factor.|||0.0104|-0.0110|0.957
72355059|NCT02831764|144227732|OTHER||Mean Difference (Net)|0.0079||||0.162|TWO_SIDED|95.0|-0.0032|0.0189|||MMRM||Week 144. Covariates adjusted: Treatment, Baseline plasma HIV-1 RNA, Baseline CD4+ cell count, and Baseline EQ-5D utility, treatment\*visit and Baseline EQ-5D utility\*visit as factors and covariate, with visit as the repeated factor.|||0.0189|-0.0032|0.162
72355060|NCT02831764|144227733|OTHER||Mean Difference (Net)|-1.3||||0.045|TWO_SIDED|95.0|-2.6|0.0|||MMRM||Week 4. Covariates adjusted: Treatment, Baseline plasma HIV-1 RNA, Baseline CD4+ cell count and Baseline EQ-5D utility, treatment\*visit and Baseline EQ-5D utility\*visit as factors and covariate, with visit as the repeated factor.|||0.0|-2.6|0.045
72355061|NCT02831764|144227733|OTHER||Mean Difference (Net)|-0.6||||0.358|TWO_SIDED|95.0|-1.9|0.7|||MMRM||Week 24. Covariates adjusted: Treatment, Baseline plasma HIV-1 RNA, Baseline CD4+ cell count and Baseline EQ-5D utility, treatment\*visit and Baseline EQ-5D utility\*visit as factors and covariate, with visit as the repeated factor.|||0.7|-1.9|0.358
72355062|NCT02831764|144227733|OTHER||Mean Difference (Net)|-0.6||||0.328|TWO_SIDED|95.0|-1.9|0.6|||MMRM||Week 48. Covariates adjusted: Treatment, Baseline plasma HIV-1 RNA, Baseline CD4+ cell count, and Baseline EQ-5D utility, treatment\*visit and Baseline EQ-5D utility\*visit as factors and covariate, with visit as the repeated factor.|||0.6|-1.9|0.328
72355063|NCT02831764|144227734|OTHER||Mean Difference (Net)|-0.7||||0.318|TWO_SIDED|95.0|-2.1|0.7|||MMRM||Week 96. Covariates adjusted: Treatment, Baseline plasma HIV-1 RNA, Baseline CD4+ cell count and Baseline EQ-5D utility, treatment\*visit and Baseline EQ-5D utility\*visit as factors and covariate, with visit as the repeated factor.|||0.7|-2.1|0.318
72355064|NCT02831764|144227735|OTHER||Mean Difference (Net)|0.3||||0.674|TWO_SIDED|95.0|-1.0|1.6|||MMRM||Week 144. Covariates adjusted: Treatment, Baseline plasma HIV-1 RNA, Baseline CD4+ cell count and Baseline EQ-5D utility, treatment\*visit and Baseline EQ-5D utility\*visit as factors and covariate, with visit as the repeated factor.|||1.6|-1.0|0.674
72355065|NCT04564846|144227736|OTHER||Risk Ratio (RR)|0.974||||0.1628|TWO_SIDED|95.0|0.938|1.011|||Analysis of Covariance||Estimated Difference from Placebo Across All Time Points. Log transformed values analyzed using an Analysis of Covariance model with treatment and time point as effects and baseline HbA1c as a covariate.|Comparison to Placebo Across All Time Points||1.011|0.938|0.1628
72355066|NCT04564846|144227738|OTHER||Risk Ratio (RR)|0.784||||0.0674|TWO_SIDED|95.0|0.605|1.017|||Analysis of Covariance|||Estimated Difference from Placebo Across All Time Points|Log transformed values analyzed using an Analysis of Covariance model with treatment and time point as effects and baseline HbA1c as a covariate.|1.017|0.605|0.0674
72355067|NCT04564846|144227739|OTHER|Log transformed values analyzed using an Analysis of Covariance model with treatment and time point as effects and baseline HbA1c as a covariate.|Risk Ratio, log|1.067||||0.8182|TWO_SIDED|95.0|0.976|1.167|||Analysis of Covariance|||Estimated Difference from Placebo Across All Time Points.||1.167|0.976|0.8182
72355068|NCT04564846|144227740|OTHER|AUC Parameters analyzed using an Analysis of Covariance model with treatment as the main effect and baseline HbA1c as a covariate.|Risk Ratio, log|1.007||||0.8182|TWO_SIDED|95.0|0.951|1.066|||Analysis of Covariance|||||1.066|0.951|0.8182
72355069|NCT04564846|144227741|OTHER||Analysis of Variance|0.4628|||||TWO_SIDED|||||Parameter analyzed using an Analysis of Variance model with treatment as the main effect.||||||||
72355070|NCT03112681|144227768|SUPERIORITY|||||||0.0001|||||||paired t-test|||||||0.0001
72355071|NCT03112681|144227768|SUPERIORITY|||||||0.0002|||||||paired t-test|||||||0.0002
72355072|NCT00453154|144227774|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using a 1-sided significance level of 0.15, the study has approximately 89% power to reject the null hypothesis|Hazard Ratio (HR)|1.62||||0.02|TWO_SIDED|70.0|1.27|2.08||All randomization was done using a permuted-block scheme with a block size of 6, stratified by combination chemotherapy (cisplatin vs carboplatin) and number of combination chemotherapy cycles (\< 6 vs 6 cycles)|Log Rank|||||2.08|1.27|0.02
72355073|NCT01790594|144227781|SUPERIORITY||Mean Difference (Final Values)|2.088||||0.75|TWO_SIDED|95.0|-11.067|15.242|||Mixed Models Analysis|||The p-value compares Investigational arm and control arm.||15.242|-11.067|0.750
72355074|NCT03016312|144227821|SUPERIORITY||Hazard Ratio (HR)|1.184||||0.094|TWO_SIDED|95.0|0.971|1.445|||Log Rank|||Unstratified Analysis||1.445|0.971|0.0940
72355075|NCT03016312|144227821|SUPERIORITY||Hazard Ratio (HR)|1.118||||0.2786|TWO_SIDED|95.0|0.913|1.37|||Log Rank|||Stratified Analysis||1.370|0.913|0.2786
72355076|NCT03016312|144227822|SUPERIORITY||Difference in Event Free Rate|-0.2||||0.9391|TWO_SIDED|95.0|-5.38|4.97|||z-test|||Difference in Event Free Rate - 6 months||4.97|-5.38|0.9391
72355077|NCT03016312|144227822|SUPERIORITY||Difference in Event Free Rate|-4.03||||0.2706|TWO_SIDED|95.0|-11.21|3.14|||z-test|||Difference in Event Free Rate - 12 months||3.14|-11.21|0.2706
72355078|NCT03016312|144227824|SUPERIORITY||Hazard Ratio (HR)|0.917||||0.3157|TWO_SIDED|95.0|0.775|1.086|||Log Rank|||Unstratified Analysis||1.086|0.775|0.3157
72355079|NCT03016312|144227824|SUPERIORITY||Hazard Ratio (HR)|0.899||||0.2366|TWO_SIDED|95.0|0.754|1.072|||Log Rank|||Stratified Analysis||1.072|0.754|0.2366
72355080|NCT03016312|144227825|SUPERIORITY||Difference in Event Free Rate|2.21||||0.5959|TWO_SIDED|95.0|-5.95|10.37|||z-test|||Difference in Event Free Rate - 6 months||10.37|-5.95|0.5959
72355081|NCT03016312|144227825|SUPERIORITY||Difference in Event Free Rate|1.44||||0.6262|TWO_SIDED|95.0|-4.35|7.23|||z-test|||Difference in Event Free Rate - 12 months||7.23|-4.35|0.6262
72355082|NCT03016312|144227826|SUPERIORITY||Difference in 50% Decrease Response Rate|1.6|||||TWO_SIDED|2.0|-4.5|7.8|||||||Odds Ratio: 1.1 95%CI: 0.8, 1.5|7.8|-4.5|
72355083|NCT03016312|144227827|SUPERIORITY||Hazard Ratio (HR)|1.055||||0.5359|TWO_SIDED|95.0|0.89|1.251|||Log Rank|||Unstratified Analysis||1.251|0.890|0.5359
72355084|NCT03016312|144227827|SUPERIORITY||Hazard Ratio (HR)|1.037||||0.6857|TWO_SIDED|95.0|0.869|1.238|||Log Rank|||Stratified Analysis||1.238|0.869|0.6857
72355085|NCT05757648|144227840|SUPERIORITY|||||||0.005|TWO_SIDED|95.0|||||Mixed Models Analysis|||||||0.005
72355086|NCT05757648|144227841|SUPERIORITY|||||||0.775|||||||Mixed Models Analysis|||||||0.775
72355087|NCT05757648|144227842|SUPERIORITY|||||||0.682|||||||Mixed Models Analysis|||||||0.682
72355088|NCT02748863|144227846|SUPERIORITY||Odds Ratio (OR)|717.42|||<|0.0001|TWO_SIDED|95.0|68.0|7569.56|||Regression, Logistic|||||7569.56|68.00|< 0.0001
72355089|NCT02748863|144227847|SUPERIORITY||Odds Ratio (OR)|168.39|||<|0.0001|TWO_SIDED|95.0|21.2|1337.22|||Regression, Logistic|||||1337.22|21.20|< 0.0001
72355090|NCT02748863|144227848|SUPERIORITY||Risk Difference (RD)|38.75|||<|0.0001|TWO_SIDED|95.0|27.41|50.09|||t-test, 2 sided|||||50.09|27.41|< 0.0001
72355091|NCT02748863|144227848|SUPERIORITY||Risk Difference (RD)|36.48|||<|0.0001|TWO_SIDED|95.0|25.19|47.76|||t-test, 2 sided|||||47.76|25.19|< 0.0001
72355092|NCT02748863|144227850|SUPERIORITY||Odds Ratio (OR)|400.58|||<|0.0001|TWO_SIDED|95.0|47.48|3379.99|||Regression, Logistic|||||3379.99|47.48|< 0.0001
72355093|NCT00657046|144227873|SUPERIORITY_OR_OTHER|||||||0.693|||||||ANCOVA|GLM model with baseline as a covariate.||||||0.693
72355094|NCT00657046|144227873|SUPERIORITY_OR_OTHER|||||||0.807|||||||ANCOVA|GLM model with baseline as a covariate.||||||0.807
72355095|NCT00657046|144227874|SUPERIORITY_OR_OTHER|||||||0.212|||||||ANCOVA|GLM model with baseline as a covariate.||||||0.212
72355096|NCT00657046|144227874|SUPERIORITY_OR_OTHER|||||||0.23|||||||ANCOVA|GLM model with baseline as a covariate.||||||0.230
72355097|NCT00657046|144227875|SUPERIORITY_OR_OTHER|||||||0.712|||||||ANCOVA|GLM model with baseline as a covariate.||||||0.712
72355098|NCT00657046|144227875|SUPERIORITY_OR_OTHER|||||||0.607|||||||ANCOVA|GLM model with baseline as a covariate.||||||0.607
72355099|NCT00657046|144227876|SUPERIORITY_OR_OTHER|||||||0.4602|||||||ANCOVA|GLM model with baseline as a covariate||||||0.4602
72355100|NCT00657046|144227876|SUPERIORITY_OR_OTHER|||||||0.94|||||||ANCOVA|GLM model with baseline as a covariate||||||0.940
72355101|NCT00657046|144227877|SUPERIORITY_OR_OTHER|||||||0.376|||||||ANCOVA|GLM model with baseline as a covariate||||||0.376
72355102|NCT00657046|144227877|SUPERIORITY_OR_OTHER|||||||0.903|||||||ANCOVA|GLM model with baseline as a covariate||||||0.903
72355103|NCT00657046|144227878|SUPERIORITY_OR_OTHER|||||||0.319|||||||ANCOVA|GLM model with baseline as a covariate||||||0.319
72355104|NCT00657046|144227878|SUPERIORITY_OR_OTHER|||||||0.408|||||||ANCOVA|GLM model with baseline as a covariate||||||0.408
72355105|NCT00657046|144227879|SUPERIORITY_OR_OTHER|||||||0.004|||||||ANCOVA|GLM model with baseline as a covariate||||||0.004
72355106|NCT00657046|144227879|SUPERIORITY_OR_OTHER|||||||0.03|||||||ANCOVA|GLM model with baseline as a covariate||||||0.030
72355107|NCT00657046|144227880|SUPERIORITY_OR_OTHER|||||||0.025|||||||ANCOVA|GLM model with baseline as a covariate||||||0.025
72355108|NCT00657046|144227880|SUPERIORITY_OR_OTHER|||||||0.022|||||||ANCOVA|GLM model with baseline as a covariate.||||||0.022
72355109|NCT00657046|144227881|SUPERIORITY_OR_OTHER|||||||0.082|||||||Fisher Exact|||||||0.082
72355110|NCT00657046|144227881|SUPERIORITY_OR_OTHER|||||||0.008|||||||Fisher Exact|||||||0.008
72355111|NCT00101686|144227904|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.433||||0.0152||95.0|1.09|1.89||p-value corresponds to the log-rank test for comparing Kaplan-Meier survival curves.|Log Rank||Hazard ratio \[mIRI:FOLFIRI\] is from the Cox Proportional Hazard Model using treatment (FOLFIRI, mIRI, CapeIRI), age (\<=70 vs \>70), performance status (0 vs 1), aspirin (Yes vs No), celecoxib (Yes or No) as the covariates.|||1.89|1.09|0.0152
72355112|NCT00101686|144227905|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.512||||0.0042||95.0|1.16|1.97|||Log Rank|||||1.97|1.16|0.0042
72355113|NCT00101686|144227905|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.368||||0.0156||95.0|1.04|1.8|||Log Rank|||||1.80|1.04|0.0156
72355114|NCT00101686|144227905|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.057||||0.4659||95.0|0.81|1.38|||Log Rank|||||1.38|0.81|0.4659
72355115|NCT00101686|144227906|SUPERIORITY_OR_OTHER||F-distribution method|47.2||||||95.0|38.85|55.71|||||Exact confidence interval for binomial proportion using the F-distribution method (unit: %)|||55.71|38.85|
72355116|NCT00101686|144227906|SUPERIORITY_OR_OTHER||F-distribution method|43.3||||||95.0|34.95|51.86|||||Exact confidence interval for binomial proportion using the F-distribution method (unit: %)|||51.86|34.95|
72355117|NCT00101686|144227906|SUPERIORITY_OR_OTHER||F-distribution method|38.6||||||95.0|30.66|47.06|||||Exact confidence interval for binomial proportion using the F-distribution method (unit: %)|||47.06|30.66|
72355118|NCT00101686|144227906|SUPERIORITY_OR_OTHER|||||||0.4751|||||||Cochran-Mantel-Haenszel|||||||0.4751
72355119|NCT00101686|144227906|SUPERIORITY_OR_OTHER|||||||0.1591|||||||Cochran-Mantel-Haenszel|||||||0.1591
72355120|NCT00101686|144227906|SUPERIORITY_OR_OTHER|||||||0.4395|||||||Cochran-Mantel-Haenszel|||||||0.4395
72355121|NCT00101686|144227907|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.268||||0.0879||95.0|0.96|1.68|||Log Rank|||||1.68|0.96|0.0879
72355122|NCT00101686|144227907|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.19||||0.2765||95.0|0.9|1.58|||Log Rank|||||1.58|0.90|0.2765
72355123|NCT00101686|144227907|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.049||||0.9364||95.0|0.8|1.38|||Log Rank|||||1.38|0.80|0.9364
72355124|NCT00101686|144227909|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.068||||0.7163||95.0|0.86|1.33|||Log Rank|||||1.33|0.86|0.7163
72355125|NCT00101686|144227910|SUPERIORITY_OR_OTHER||F-distribution method|39.4||||||95.0|32.83|46.34|||||confidence interval for binomial proportion using the F-distribution method (unit: %)|||46.34|32.83|
72355126|NCT00101686|144227910|SUPERIORITY_OR_OTHER||F-distribution method|46.5||||||95.0|39.76|53.42|||||confidence interval for binomial proportion using the F-distribution method (unit: %)|||53.42|39.76|
72355127|NCT00101686|144227910|SUPERIORITY_OR_OTHER|||||||0.1559|||||||Cochran-Mantel-Haenszel|||||||0.1559
72355128|NCT00101686|144227911|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.08||||0.5316||95.0|0.86|1.36|||Log Rank|||||1.36|0.86|0.5316
72355129|NCT00101686|144227912|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.269||||0.2835||95.0|0.75|2.15|||Log Rank|||||2.15|0.75|0.2835
72355130|NCT00101686|144227913|SUPERIORITY_OR_OTHER||F-distribution method|57.9||||||95.0|44.08|70.86|||||Exact confidence interval for binomial proportion using the F-distribution method (unit: %)|||70.86|44.08|
72355131|NCT00101686|144227913|SUPERIORITY_OR_OTHER||F-distribution method|53.3||||||95.0|40.0|66.33|||||Exact confidence interval for binomial proportion using the F-distribution method (unit: %)|||66.33|40.00|
72355132|NCT00101686|144227913|SUPERIORITY_OR_OTHER|||||||0.7388|||||||Cochran-Mantel-Haenszel|||||||0.7388
72355133|NCT00101686|144227915|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.794||||0.037||95.0|1.12|2.88|||Log Rank|||||2.88|1.12|0.0370
72355134|NCT00890825|144227925|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.8||||0.2069|TWO_SIDED|80.0|0.56|1.14||One-sided p-value. The p-value is associated with the point estimate (e.g. HR comparing AZD6244 + Docetaxel vs Placebo + Docetaxel) on the outcome measure - Overall survival.|Regression, Cox|Analysis adjusted for the following covariates; WHO PS, gender, histology and smoking status|A Hazard Ratio less than 1 favoured AZD6244 + Docetaxel|||1.14|0.56|0.2069
72355135|NCT00890825|144227926|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.58||||0.0138|TWO_SIDED|80.0|0.42|0.79||One-sided p-value. The p-value is associated with the point estimate (e.g. HR comparing AZD6244 + Docetaxel vs Placebo + Docetaxel) on the outcome measure.|Regression, Cox|The model allowed for the effect of treatment and included terms for WHO PS, gender, histology, and smoking status.|A Hazard Ratio (HR) \< 1 favoured AZD6244 + Docetaxel|||0.79|0.42|0.0138
72355136|NCT00890825|144227927|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|37.2|||<|0.0001|TWO_SIDED|95.0|23.0|53.0||Two-sided P-value|Fisher Exact|||||53|23|< 0.0001
72355137|NCT00890825|144227929|SUPERIORITY_OR_OTHER||LSmeans difference|-17.03||||0.004|TWO_SIDED|80.0|-25.2|-8.86||One-sided p-value. The p-value is associated with the point estimate comparing AZD6244 + Docetaxel vs Placebo + Docetaxel on the outcome measure.|ANCOVA|LS means were adjusted for baseline tumour size, time from baseline scan to randomisation, WHO PS, gender, histology, and smoking status.|(AZD6244 + Docetaxel) - (Placebo + Docetaxel)|||-8.86|-25.2|0.004
72355138|NCT00890825|144227930|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-26.0||||0.004|TWO_SIDED|80.0|-38.34|-13.7||One-sided p-value. The p-value is associated with the point estimate comparing AZD6244 + Docetaxel vs Placebo + Docetaxel on the outcome measure.|ANCOVA|LS means were adjusted for baseline tumour size, time from baseline scan to randomisation, WHO PS, gender, histology, and smoking status|(AZD6244 + Docetaxel) - (Placebo + Docetaxel)|||-13.7|-38.34|0.004
72355139|NCT00890825|144227931|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.54||||0.0158|TWO_SIDED|80.0|0.37|0.78||One-sided p-value. The p-value is associated with the point estimate (e.g. HR comparing AZD6244 + Docetaxel vs Placebo + Docetaxel) on the outcome measure.|Log Rank|Confidence interval (CI) used Greenwood's formula for the standard error of a survival estimate|A hazard ratio (HR) \<1 favours AZD6244 75 mg bd+Docetaxel|||0.78|0.37|0.0158
72355140|NCT02920892|144227953|SUPERIORITY||Slope|-0.1||||0.1587|TWO_SIDED|90.0|-0.22|0.02|||Mixed Models Analysis|||||0.02|-0.22|0.1587
72355141|NCT02920892|144227954|SUPERIORITY||Slope|-1.66||||0.1054|TWO_SIDED|90.0|-3.34|0.03|||Mixed Models Analysis|||||0.03|-3.34|0.1054
72355142|NCT02920892|144227955|SUPERIORITY||Slope|-0.67||||0.32|TWO_SIDED|90.0|-1.79|0.45|||Mixed Models Analysis|||||0.45|-1.79|0.32
72355143|NCT02920892|144227956|SUPERIORITY||Slope|-0.29||||0.78|TWO_SIDED|90.0|-1.98|1.4|||Mixed Models Analysis|||||1.4|-1.98|0.78
72355144|NCT02920892|144227957|SUPERIORITY||Slope|0.1||||0.94|TWO_SIDED|90.0|-2.05|2.24|||Mixed Models Analysis|||||2.24|-2.05|0.94
72355145|NCT02920892|144227958|SUPERIORITY||Slope|-0.85||||0.1428|TWO_SIDED|90.0|-1.81|0.11|||Mixed Models Analysis|||||0.11|-1.81|0.1428
72355146|NCT02920892|144227959|SUPERIORITY||Odds Ratio (OR)|0.9462||||0.24|TWO_SIDED|90.0|0.8764|1.0215|||Mixed Models Analysis|||||1.0215|0.8764|0.24
72355147|NCT02920892|144227960|SUPERIORITY||Odds Ratio (OR)|0.95||||0.92|TWO_SIDED|90.0|0.4|2.27|||Mixed Models Analysis|||||2.27|0.4|0.92
72355148|NCT03649217|144227975|SUPERIORITY|||||||0.0001|||||||ANOVA|||||||.0001
72355149|NCT03649217|144227976|SUPERIORITY|||||||0.0001|||||||ANOVA|||||||.0001
72355150|NCT03649217|144227977|SUPERIORITY|||||||0.001|||||||ANOVA|||||||.001
72355151|NCT03649217|144227978|SUPERIORITY|||||||0.0002|||||||ANOVA|||||||.0002
72355152|NCT03649217|144227979|SUPERIORITY|||||||0.006|||||||ANOVA|||||||.006
72355153|NCT00721396|144227986|NON_INFERIORITY_OR_EQUIVALENCE|Immune response of Group B+R246 was considered non-inferior to response of Group B246\_R357, if at one month after the third rMenB+OMV NZ injection the 2-sided 95% lower confidence interval of the difference in the percentage of subjects with hSBA titer ≥1:5 was greater than -10% for each of the 3 strains.|Difference % (B+R246 minus B246_R357)|0.0|||||TWO_SIDED|95.0|-1.0|1.0|||Miettinen and Nurminen method|||Non-inferiority of immune responses against 44/76-SL strain when rMenB+OMV NZ vaccine was administered concomitantly with routine infant vaccines as compared to when rMenB+OMV NZ vaccine and routine vaccines were given separately.||1|-1|
72355154|NCT00721396|144227986|NON_INFERIORITY_OR_EQUIVALENCE|Immune response of Group B+R246 was considered non-inferior to response of Group B246\_R357, if at one month after the third rMenB+OMV NZ injection the 2-sided 95% lower confidence limit of the difference in the percentage of subjects with hSBA titer ≥5 was greater than -10% for each of the 3 strains.|Difference %(B+R246 minus B246_R357)|0.0|||||TWO_SIDED|95.0|-1.0|1.0|||Miettinen and Nurminen method|||Non-inferiority of immune responses against 5/99 strain when rMenB+OMV NZ vaccine was administered concomitantly with routine infant vaccines as compared to when rMenB+OMV NZ vaccine and routine vaccines were given separately.||1|-1|
72355155|NCT00721396|144227986|NON_INFERIORITY_OR_EQUIVALENCE|Immune response of Group B+R246 was considered non-inferior to response of Group B246\_R357, if at one month after the third rMenB+OMV NZ injection the 2-sided 95% lower confidence limit of the difference in the percentage of subjects with hSBA titer ≥5 was greater than -10% for each of the 3 strains.|Difference % (B+R246 minus B246_R357)|-8.0|||||TWO_SIDED|95.0|-12.0|-4.0|||Miettinen and Nurminen method|||Non-inferiority of immune responses against NZ98/254 strain when rMenB+OMV NZ vaccine was administered concomitantly with routine infant vaccines as compared to when rMenB+OMV NZ vaccine and routine vaccines were given separately.||-4|-12|
72355156|NCT00721396|144227987|NON_INFERIORITY_OR_EQUIVALENCE|Immune response of Group B+R234 was considered non-inferior to response of Group R234, if at one month after the third injection the 2-sided 95% lower confidence limit for the difference in the percentage of subjects with antibody response greater than the pre-specified cut off of for diphtheria (≥0.1 IU/mL) was \>-10%.|Difference %(B+R234 minus R234)|0.0|||||TWO_SIDED|95.0|-1.0|2.0|||Miettinen and Nurminen method|||Non-inferiority of immune responses against Diphtheria antigen when routine vaccine was administered concomitantly with rMenB+OMV NZ vaccine to when only routine vaccines were administered.||2|-1|
72355157|NCT00721396|144227987|NON_INFERIORITY_OR_EQUIVALENCE|Immune response of Group B+R234 was considered non-inferior to response of Group R234, if at one month after the third injection the 2-sided 95% lower confidence limit for the difference in the percentage of subjects with antibody response greater than the pre-specified cut off of for tetanus toxoid (≥0.1 IU/mL) was \>-10%.|Difference %(B+R234 minus R234)|0.0|||||TWO_SIDED|95.0|-1.0|2.0|||Miettinen and Nurminen|||Non-inferiority of immune response to Tetanus antigens when routine vaccines are administered concomitantly with rMen+OMV NZ vaccine.||2|-1|
72355158|NCT00721396|144227992|NON_INFERIORITY_OR_EQUIVALENCE|Group B+R234 was to be considered non-inferior to Group R234 if the 2-sided 95% lower confidence limit of this difference at 30 days after the last injection was greater than -10% for each of the antigens of the routine vaccinations.|Difference %(B+R234 minus R234)|-1.0|||||TWO_SIDED|95.0|-5.0|4.0|||Miettinen and Nurminen method|||Non-inferiority of immune responses against Pertussis antigen FHA when routine vaccine was administered concomitantly with rMenB+OMV NZ vaccine to when only routine vaccines were administered.||4|-5|
72355159|NCT00721396|144227992|NON_INFERIORITY_OR_EQUIVALENCE|Group B+R234 was to be considered non-inferior to Group R234 if the 2-sided 95% lower confidence limit of this difference at 30 days after the last injection was greater than -10% for each of the antigens of the routine vaccinations.|Difference %(B+R234 minus R234)|-2.0|||||TWO_SIDED|95.0|-7.0|2.0|||Miettinen and Nurminen method|||Non-inferiority of immune responses against Pertussis antigen pertactin antigen when routine vaccine was administered concomitantly with rMenB+OMV NZ vaccine to when only routine vaccines were administered.||2|-7|
72355160|NCT00721396|144227992|NON_INFERIORITY_OR_EQUIVALENCE|Group B+R234 was to be considered non-inferior to Group R234 if the 2-sided 95% lower confidence limit of this difference at 30 days after the last injection was greater than -10% for each of the antigens of the routine vaccinations.|Difference %(B+R234 minus R234)|-1.0|||||TWO_SIDED|95.0|-4.0|2.0|||Miettinen and Nurminen method|||Non-inferiority of immune responses against Pertussis antigen PT when routine vaccine was administered concomitantly with rMenB+OMV NZ vaccine to when only routine vaccines were administered.||2|-4|
72355161|NCT03546621|144227993|SUPERIORITY||||||<|0.0001|||||||Bonferroni-Holm|||For each of the three Myrcludex B treatment groups, a null hypothesis of no clinically significant difference in proportion of responders compared to the control group (Tenofovir only), at week 24, were tested using the one-sided Wald test for superiority, at a one-sided overall significance level of 0.05 adjusted for multiple testing according to Bonferroni-Holm, with the superiority limit (test margin) set to 5%.||||<.0001
72355162|NCT03546621|144227994|SUPERIORITY|||||||0.9818||||||A test is considered as statistically significant if the adjusted p-value is smaller than 0.05.|Bonferroni-Holm|||Week 48. Two-sided Fisher's exact tests were used to test null hypothesis of no difference in the proportion of responders compared to the Tenofovir only group. Separate comparisons were made for each of the three Myrcludex B groups versus the control group, and the adjusted p-values were computed using the Bonferroni-Holm method.||||0.9818
72355163|NCT03546621|144227994|SUPERIORITY|||||||1||||||A test is considered as statistically significant if the adjusted p-value as smaller than 0.05|Bonferroni-Holm|||Week 48. Two-sided Fisher's exact tests were used to test null hypothesis of no difference in the proportion of responders compared to the Tenofovir only group. Separate comparisons were made for each of the three Myrcludex B groups versus the control group, and the adjusted p-values were computed using the Bonferroni-Holm method.||||1.0000
72355164|NCT03546621|144227994|SUPERIORITY|||||||0.7132||||||The threshold for statistical significance was p=0.05|Bonferroni-Holm|||Week 48. Two-sided Fisher's exact tests were used to test null hypothesis of no difference in the proportion of responders compared to the Tenofovir only group. Separate comparisons were made for each of the three Myrcludex B groups versus the control group, and the adjusted p-values were computed using the Bonferroni-Holm method.||||0.7132
72429289|NCT01500226|144369560|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.6|||<|0.001|TWO_SIDED|95.0|1.3|2.0||To control for multiplicity, analyses were performed hierarchically. CR overall was tested only if both CR delayed and CR acute were statistically significant.|Cochran-Mantel-Haenszel|Cochran Mantel Haenszel (CMH) test was stratified by sex. Missing data were imputed as treatment failures.||||2.0|1.3|<0.001
72355165|NCT03546621|144227995|SUPERIORITY|||||||0.0232||||||A test is considered as statistically significant if the adjusted p-value is smaller than 0.05.|Bonferroni-Holm|||"Fisher's exact test was used to test a null hypothesis of no difference in proportions against a two-sided alternative hypothesis. Separate tests were performed for each of the three Myrcludex B treatment groups against the control group, at week 24 and week 48, and adjusted p-values were computered using the Bonferroni-Holm method.~This analysis, and presentation of descriptive statistics, was repeated for the subgroups of patients with normal/abnormal baseline ALT values."||||0.0232
72355166|NCT03546621|144227995|SUPERIORITY|||||||0.0047||||||The threshold for statistical significance was p=0.05|Bonferroni-Holm|||Fisher's exact test was used to test a null hypothesis of no difference in proportions against a two-sided alternative hypothesis. Separate tests were performed for each of the three Myrcludex B treatment groups against the control group, at week 24 and week 48, and adjusted p-values were computered using the Bonferroni-Holm method.||||0.0047
72355167|NCT03546621|144227995|SUPERIORITY|||||||0.001||||||The threshold for statistical significance was p=0.05|Bonferroni-Holm|||Fisher's exact test was used to test a null hypothesis of no difference in proportions against a two-sided alternative hypothesis. Separate tests were performed for each of the three Myrcludex B treatment groups against the control group, at week 24 and week 48, and adjusted p-values were computered using the Bonferroni-Holm method.||||0.0010
72355168|NCT03546621|144227996|SUPERIORITY|||||||0.1642||||||A test is considered as statistically significant if the adjusted p-value is smaller than 0.05.|Bonferroni-Holm|||"Week 24. The change from baseline to week 24 and week 48 in ALT levels was performed using van Elteren tests.~Fisher's exact test was used to test a null hypothesis of no difference in proportions (of patients with normal ALT values) against a two-sided alternative hypothesis. Separate tests were performed for each of the three Myrcludex B treatment groups against the control group, at week 24 and week 48, and adjusted p-values were computed using the Bonferroni-Holm method."||||0.1642
72355169|NCT03546621|144227996|SUPERIORITY|||||||0.0428||||||A test is considered statistically significant if the adjusted p-value is smaller than 0.05|Bonferroni-Holm|||Week 24||||0.0428
72355170|NCT03546621|144227996|SUPERIORITY|||||||0.0428||||||A test is considered statistically significant if the adjusted p-value is smaller than 0.05|Bonferroni-Holm|||Week 24||||0.0428
72355171|NCT03546621|144227996|SUPERIORITY|||||||0.2388||||||A test is considered as statistically significant if the adjusted p-value is smaller than 0.05.|Boferroni-Holm|||Week 48||||0.2388
72355172|NCT03546621|144227996|SUPERIORITY|||||||0.7157||||||A test is considered as statistically significant if the adjusted p-value is smaller than 0.05.|Bonferroni-Holm|||Week 48||||0.7157
72355173|NCT03546621|144227996|SUPERIORITY|||||||0.2388||||||A test is considered as statistically significant if the adjusted p-value is smaller than 0.05.|Bonferroni-Holm|||Week 48||||0.2388
72355174|NCT03546621|144227997|SUPERIORITY|||||||0.7416||||||A test is considered as statistically significant if the adjusted p-value is smaller than 0.05.|Bonferroni-Holm|||"Week 24. Two-sided van Elteren tests, stratified by presence of cirrhosis, were used to test for differences compared to the control group.~Separate comparisons were made for each of the three MXB groups versus the control group, and adjusted p-values were computed using the Bonferroni-Holm method."||||0.7416
72355175|NCT03546621|144227997|SUPERIORITY|||||||0.4434||||||A test is considered as statistically significant if the adjusted p-value is smaller than 0.05.|Bonferroni-Holm|||Week 24||||0.4434
72355176|NCT03546621|144227997|SUPERIORITY|||||||0.7371||||||A test is considered as statistically significant if the adjusted p-value is smaller than 0.05.|Bonferroni-Holm|||Week 24.||||0.7371
72355177|NCT03546621|144227997|SUPERIORITY|||||||1||||||A test is considered as statistically significant if the adjusted p-value is smaller than 0.05.|Bonferroni-Holm|||Week 48||||1.0000
72355178|NCT03546621|144227997|SUPERIORITY|||||||0.9441||||||A test is considered as statistically significant if the adjusted p-value is smaller than 0.05.|Bonferroni-Holm|||Week 48||||0.9441
72429290|NCT04212169|144369561|SUPERIORITY||Mean Difference (Final Values)|1.27|STANDARD_ERROR_OF_MEAN|8.981||0.888|TWO_SIDED|90.0|-13.67|16.22|||Mixed Models Analysis||Differences less than 0 favours MEDI3506|||16.22|-13.67|0.888
72429291|NCT04212169|144369561|SUPERIORITY||Mean Difference (Final Values)|5.87|STANDARD_ERROR_OF_MEAN|9.756||0.549|TWO_SIDED|90.0|-10.36|22.1|||Mixed Models Analysis||Differences less than 0 favours MEDI3506|||22.10|-10.36|0.549
72355179|NCT03546621|144227997|SUPERIORITY|||||||1||||||A test is considered as statistically significant if the adjusted p-value is smaller than 0.05.|Bonferroni-Holm|||Week 48||||1.0000
72355180|NCT03546621|144227998|SUPERIORITY||Bonferroni-Holm|||||0.5984||||||A test is considered as statistically significant if the adjusted p-value is smaller than 0.05.|Bonferroni-Holm|||"Week 24. The change from baseline to Week 24 in HBsAg was performed using van Elteren tests. Tests were performed on log-10 transformed data.~Separare comparisons were made for each of the three Myrcludex B groups versus the control group, and the adjusted values were computed using the Bonferroni-Holm method."||||0.5984
72355181|NCT03546621|144227998|SUPERIORITY|||||||0.7529||||||A test is considered as statistically significant if the adjusted p-value is smaller than 0.05.|Bonferroni-Holm|||Week 24||||0.7529
72355182|NCT03546621|144227998|SUPERIORITY|||||||0.3305||||||A test is considered as statistically significant if the adjusted p-value is smaller than 0.05.|Bonferroni-Holm|||Week 24||||0.3305
72355183|NCT03546621|144227998|SUPERIORITY|||||||1||||||A test is considered as statistically significant if the adjusted p-value is smaller than 0.05.|Bonferroni-Holm|||Week 48||||1.0000
72355184|NCT03546621|144227998|SUPERIORITY|||||||1||||||A test is considered as statistically significant if the adjusted p-value is smaller than 0.05.|Bonferroni-Holm|||Week 48||||1.0000
72355185|NCT03546621|144227998|SUPERIORITY|||||||1||||||A test is considered as statistically significant if the adjusted p-value is smaller than 0.05.|Bonferroni-Holm|||Week 48||||1.0000
72355186|NCT03546621|144227999|SUPERIORITY|||||||1||||||A test is considered as statistically significant if the adjusted p-value is smaller than 0.05.|Bonferroni-Holm|||"Week 24. Two-sided van Elteren tests, stratified by presence of cirrhosis, were used to test for differences compared to the control group.~Tests were performed on log-10 transformed data. Separate comparisons were made for each of the three MXB groups versus the control group, and adjusted p-values were computed using the Bonferroni-Holm method."||||1.0000
72355187|NCT03546621|144227999|SUPERIORITY|||||||1|||||||Bonferroni-Holm|||Week 24.||||1.0000
72429292|NCT04212169|144369561|SUPERIORITY||Mean Difference (Final Values)|-1.72|STANDARD_ERROR_OF_MEAN|7.014||0.807|TWO_SIDED|90.0|-13.38|9.95|||Mixed Models Analysis||Differences less than 0 favours MEDI3506|||9.95|-13.38|0.807
72355188|NCT03546621|144227999|SUPERIORITY|||||||1|||||||Bonferroni-Holm|||Week 24||||1.0000
72355189|NCT03546621|144227999|SUPERIORITY|||||||1||||||A test is considered as statistically significant if the adjusted p-value is smaller than 0.05|Bonferroni-Holm|||Week 48||||1.0000
72355190|NCT03546621|144227999|SUPERIORITY|||||||1||||||A test is considered as statistically significant if the adjusted p-value is smaller than 0.05.|Bonferroni-Holm|||Week 48||||1.0000
72355191|NCT03546621|144227999|SUPERIORITY|||||||1||||||A test is considered as statistically significant if the adjusted p-value is smaller than 0.05.|Bonferroni-Holm|||Week 48||||1.0000
72355192|NCT02021565|144228015|SUPERIORITY|||||||0.973||||||alpha = 0.025|ANOVA|Repeated measures||Analysis 1 is for the caregiver reported confidence that Veteran care recipient can perform 10 transfer tasks with assistance from the informal caregiver.||||0.973
72355193|NCT02021565|144228015|SUPERIORITY|Alpha = .025||||||0.223|||||||ANOVA|||Analysis 2 is for the caregiver reported confidence that Veteran care recipient can perform 10 transfer tasks independently.||||0.223
72355194|NCT02021565|144228016|SUPERIORITY|||||||0.547|||||||ANOVA|||Analysis 1 is for the Veteran care recipient reported task efficacy||||0.547
72355195|NCT02021565|144228016|SUPERIORITY|||||||0.891|||||||ANOVA|||Analysis 2 is for the Veteran reported confidence that he/she can perform 10 transfer tasks independently.||||0.891
72355196|NCT02021565|144228017|SUPERIORITY|||||||0.729|||||||ANOVA|||||||0.729
72355197|NCT03318549|144228018|OTHER|||||||0.011|||||||t-test, 2 sided|||||||0.011
72355198|NCT03318549|144228018|OTHER|||||||0.022|||||||t-test, 2 sided|||||||0.022
72355199|NCT03318549|144228019|OTHER|||||||0.303|||||||Chi-squared|||||||0.303
72355200|NCT03318549|144228022|OTHER|||||||0.132|||||||t-test, 2 sided|||||||0.132
72355201|NCT03318549|144228022|OTHER|||||||0.647|||||||t-test, 2 sided|||||||0.647
72355202|NCT00607087|144228038|SUPERIORITY_OR_OTHER|||||||0.039||97.5||||The p-value is adjusted for multiple comparisons. Each comparison is performed at the alpha level=2.5% (instead of 5%). Consequently a difference between 2 treatments is statistically significant if the corresponding p-value is \<0.025|McNemar|||||||0.039
72355203|NCT00607087|144228038|SUPERIORITY_OR_OTHER|||||||0.031||97.5||||The p-value is adjusted for multiple comparisons. Each comparison is performed at the alpha level=2.5% (instead of 5%). Consequently a difference between 2 treatments is statistically significant if the corresponding p-value is \<0.025.|McNemar|||||||0.031
72355204|NCT00607087|144228039|SUPERIORITY_OR_OTHER||||||<|0.001||97.5||||The p-value is adjusted for multiple comparisons. Each comparison is performed at the alpha level=2.5% (instead of 5%). Consequently a difference between 2 treatments is statistically significant if the corresponding p-value is \<0.025|Mixed Models Analysis|||||||<0.001
72355205|NCT00607087|144228039|SUPERIORITY_OR_OTHER||||||<|0.001||97.5||||The p-value is adjusted for multiple comparisons. Each comparison is performed at the alpha level=2.5% (instead of 5%). Consequently a difference between 2 treatments is statistically significant if the corresponding p-value is \<0.025|Mixed Models Analysis|||||||<0.001
72355206|NCT00607087|144228040|SUPERIORITY_OR_OTHER|||||||0.08||97.5||||The p-value is adjusted for multiple comparisons. Each comparison is performed at the alpha level=2.5% (instead of 5%). Consequently a difference between 2 treatments is statistically significant if the corresponding p-value is \<0.025|McNemar|||||||0.080
72355207|NCT00607087|144228040|SUPERIORITY_OR_OTHER|||||||0.107||97.5||||The p-value is adjusted for multiple comparisons. Each comparison is performed at the alpha level=2.5% (instead of 5%). Consequently a difference between 2 treatments is statistically significant if the corresponding p-value is \<0.025|McNemar|||||||0.107
72355208|NCT00607087|144228041|SUPERIORITY_OR_OTHER||||||<|0.001||97.5||||The p-value is adjusted for multiple comparisons. Each comparison is performed at the alpha level=2.5% (instead of 5%). Consequently a difference between 2 treatments is statistically significant if the corresponding p-value is \<0.025|Mixed Models Analysis|||||||<0.001
72355209|NCT00607087|144228041|SUPERIORITY_OR_OTHER||||||<|0.001||97.5||||The p-value is adjusted for multiple comparisons. Each comparison is performed at the alpha level=2.5% (instead of 5%). Consequently a difference between 2 treatments is statistically significant if the corresponding p-value is \<0.025|McNemar|||||||<0.001
72355210|NCT00607087|144228042|SUPERIORITY_OR_OTHER|||||||0.079||97.5||||The p-value is adjusted for multiple comparisons. Each comparison is performed at the alpha level=2.5% (instead of 5%). Consequently a difference between 2 treatments is statistically significant if the corresponding p-value is \<0.025|McNemar|||||||0.079
72355211|NCT00607087|144228042|SUPERIORITY_OR_OTHER|||||||0.063||97.5||||The p-value is adjusted for multiple comparisons. Each comparison is performed at the alpha level=2.5% (instead of 5%). Consequently a difference between 2 treatments is statistically significant if the corresponding p-value is \<0.025|McNemar|||||||0.063
72355212|NCT00607087|144228043|SUPERIORITY_OR_OTHER|||||||0.015||97.5||||The p-value is adjusted for multiple comparisons. Each comparison is performed at the alpha level=2.5% (instead of 5%). Consequently a difference between 2 treatments is statistically significant if the corresponding p-value is \<0.025|Mixed Models Analysis|||||||0.015
72355213|NCT00607087|144228043|SUPERIORITY_OR_OTHER|||||||0.073||97.5||||The p-value is adjusted for multiple comparisons. Each comparison is performed at the alpha level=2.5% (instead of 5%). Consequently a difference between 2 treatments is statistically significant if the corresponding p-value is \<0.025|Mixed Models Analysis|||||||0.073
72355214|NCT00607087|144228044|SUPERIORITY_OR_OTHER|||||||0.017||97.5||||The p-value is adjusted for multiple comparisons. Each comparison is performed at the alpha level=2.5% (instead of 5%). Consequently a difference between 2 treatments is statistically significant if the corresponding p-value is \<0.025|McNemar|||||||0.017
72355215|NCT00607087|144228044|SUPERIORITY_OR_OTHER|||||||0.032||97.5||||The p-value is adjusted for multiple comparisons. Each comparison is performed at the alpha level=2.5% (instead of 5%). Consequently a difference between 2 treatments is statistically significant if the corresponding p-value is \<0.025|McNemar|||||||0.032
72355216|NCT00607087|144228045|SUPERIORITY_OR_OTHER|||||||0.009||97.5||||The p-value is adjusted for multiple comparisons. Each comparison is performed at the alpha level=2.5% (instead of 5%). Consequently a difference between 2 treatments is statistically significant if the corresponding p-value is \<0.025|Mixed Models Analysis|||||||0.009
72355217|NCT00607087|144228045|SUPERIORITY_OR_OTHER|||||||0.019||97.5||||The p-value is adjusted for multiple comparisons. Each comparison is performed at the alpha level=2.5% (instead of 5%). Consequently a difference between 2 treatments is statistically significant if the corresponding p-value is \<0.025|Mixed Models Analysis|||||||0.019
72355218|NCT00607087|144228046|SUPERIORITY_OR_OTHER|||||||0.008||97.5||||The p-value is adjusted for multiple comparisons. Each comparison is performed at the alpha level=2.5% (instead of 5%). Consequently a difference between 2 treatments is statistically significant if the corresponding p-value is \<0.025|Mixed Models Analysis|||||||0.008
72355219|NCT00607087|144228046|SUPERIORITY_OR_OTHER||||||<|0.001||97.5||||The p-value is adjusted for multiple comparisons. Each comparison is performed at the alpha level=2.5% (instead of 5%). Consequently a difference between 2 treatments is statistically significant if the corresponding p-value is \<0.025|Mixed Models Analysis|||||||<0.001
72355220|NCT00607087|144228047|SUPERIORITY_OR_OTHER|||||||0.563||97.5||||The p-value is adjusted for multiple comparisons. Each comparison is performed at the alpha level=2.5% (instead of 5%). Consequently a difference between 2 treatments is statistically significant if the corresponding p-value is \<0.025|Mixed Models Analysis|||||||0.563
72355221|NCT00607087|144228047|SUPERIORITY_OR_OTHER|||||||0.186||97.5||||The p-value is adjusted for multiple comparisons. Each comparison is performed at the alpha level=2.5% (instead of 5%). Consequently a difference between 2 treatments is statistically significant if the corresponding p-value is \<0.025|Mixed Models Analysis|||||||0.186
72355222|NCT00607087|144228048|SUPERIORITY_OR_OTHER||||||<|0.001||97.5||||The p-value is adjusted for multiple comparisons. Each comparison is performed at the alpha level=2.5% (instead of 5%). Consequently a difference between 2 treatments is statistically significant if the corresponding p-value is \<0.025|Mixed Models Analysis|||||||<0.001
72355223|NCT00607087|144228048|SUPERIORITY_OR_OTHER||||||<|0.001||97.5||||The p-value is adjusted for multiple comparisons. Each comparison is performed at the alpha level=2.5% (instead of 5%). Consequently a difference between 2 treatments is statistically significant if the corresponding p-value is \<0.025|Mixed Models Analysis|||||||<0.001
72355224|NCT00607087|144228049|SUPERIORITY_OR_OTHER|||||||1||97.5||||The p-value is adjusted for multiple comparisons. Each comparison is performed at the alpha level=2.5% (instead of 5%). Consequently a difference between 2 treatments is statistically significant if the corresponding p-value is \<0.025|McNemar|||||||1.000
72355225|NCT00607087|144228049|SUPERIORITY_OR_OTHER|||||||0.701||97.5||||The p-value is adjusted for multiple comparisons. Each comparison is performed at the alpha level=2.5% (instead of 5%). Consequently a difference between 2 treatments is statistically significant if the corresponding p-value is \<0.025|McNemar|||||||0.701
72355226|NCT00607087|144228052|SUPERIORITY_OR_OTHER|||||||0.078||97.5||||The p-value is adjusted for multiple comparisons. Each comparison is performed at the alpha level=2.5% (instead of 5%). Consequently a difference between 2 treatments is statistically significant if the corresponding p-value is \<0.025|ANCOVA|ANCOVA adjusted on HbA1c value at the start of the first period||||||0.078
72355227|NCT00607087|144228052|SUPERIORITY_OR_OTHER|||||||0.938||97.5||||The p-value is adjusted for multiple comparisons. Each comparison is performed at the alpha level=2.5% (instead of 5%). Consequently a difference between 2 treatments is statistically significant if the corresponding p-value is \<0.025|ANCOVA|ANCOVA adjusted on HbA1c level at the start of the first period||||||0.938
72355228|NCT01774799|144228179|SUPERIORITY||Odds Ratio (OR)|1.08|||||TWO_SIDED|95.0|0.69|1.69||||||||1.69|0.69|
72355229|NCT01774799|144228180|SUPERIORITY||Hazard Ratio (HR)|1.2|||||TWO_SIDED|95.0|0.66|2.2||||||||2.20|0.66|
72355230|NCT01774799|144228181|SUPERIORITY||Odds Ratio (OR)|0.96|||||TWO_SIDED|95.0|0.58|1.58||||||||1.58|0.58|
72355231|NCT01774799|144228182|SUPERIORITY||Odds Ratio (OR)|1.79|||||TWO_SIDED|95.0|1.13|2.82||||||||2.82|1.13|
72355232|NCT01774799|144228183|SUPERIORITY|||||||0.32|||||||Regression, Linear|||||||0.32
72355233|NCT02586623|144228184|SUPERIORITY||Cox Proportional Hazard|1.04||||0.803|TWO_SIDED|95.0|0.67|1.62|||Log Rank||Droxidopa / Placebo|||1.62|0.67|0.803
72355234|NCT00871871|144228197|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.1||||0.067|TWO_SIDED|90.0|-0.22|0.01||one-sided, alpha = 0.05|ANCOVA|||||0.01|-0.22|0.067
72355235|NCT00871871|144228198|SUPERIORITY_OR_OTHER||Least squares mean difference|1.1|||>|0.5|TWO_SIDED|90.0|0.86|1.34|||ANCOVA|||||1.34|0.86|>0.500
72355236|NCT00871871|144228199|SUPERIORITY_OR_OTHER||Least squares mean difference|0.016||||0.13|TWO_SIDED|90.0|-0.012|0.044||one-sided, alpha = 0.05|ANOVA|||||0.044|-0.012|0.130
72355237|NCT00871871|144228200|SUPERIORITY_OR_OTHER||Least squares mean difference|0.54|||>|0.5|TWO_SIDED|90.0|0.4|0.67|||ANCOVA|||||0.67|0.40|>0.500
72355238|NCT00871871|144228201|SUPERIORITY_OR_OTHER||Least squares mean difference|0.004||||0.342|TWO_SIDED|90.0|-0.023|0.014||one-sided, alpha = 0.05|ANOVA|||||0.014|-0.023|0.342
72355239|NCT00871871|144228202|SUPERIORITY_OR_OTHER||Least squares mean difference|0.0016|||>|0.5|TWO_SIDED|90.0|-0.008|0.011|||ANOVA|||||0.011|-0.008|>0.500
72355240|NCT00871871|144228203|SUPERIORITY_OR_OTHER||Least squares mean difference|0.003|||>|0.5|TWO_SIDED|90.0|-0.003|0.01|||ANOVA|||||0.010|-0.003|>0.500
72355241|NCT03400475|144228205|SUPERIORITY||Mean Difference (Final Values)|-2.088||||0.9|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.90
72355242|NCT03400475|144228206|SUPERIORITY||Mean Difference (Final Values)|3.59||||0.9|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.90
72355243|NCT03400475|144228207|SUPERIORITY||Mean Difference (Final Values)|3.596||||0.9|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.90
72355244|NCT03400475|144228208|SUPERIORITY||Mean Difference (Final Values)|-0.083||||0.9|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.90
72355245|NCT03400475|144228209|SUPERIORITY||Mean Difference (Final Values)|0.581||||0.9|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.90
72355246|NCT03400475|144228210|SUPERIORITY||Mean Difference (Final Values)|0.029||||0.9|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.90
72355247|NCT03400475|144228211|SUPERIORITY||Mean Difference (Final Values)|-64.696||||0.86|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.86
72355248|NCT03400475|144228212|SUPERIORITY||Mean Difference (Final Values)|111.03||||0.86|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.86
72355249|NCT03400475|144228213|SUPERIORITY||Mean Difference (Final Values)|213.314||||0.86|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.86
72355250|NCT03400475|144228214|SUPERIORITY||Mean Difference (Final Values)|37.356||||0.41|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.41
72355251|NCT03400475|144228215|SUPERIORITY||Mean Difference (Final Values)|1.6537||||0.41|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.41
72355252|NCT03400475|144228216|SUPERIORITY||Mean Difference (Final Values)|1.552||||0.41|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.41
72355253|NCT03400475|144228217|SUPERIORITY|||||||0.071|||||||Fisher Exact|||||||0.071
72355254|NCT03400475|144228218|SUPERIORITY|||||||0.071|||||||Fisher Exact|||||||0.071
72355255|NCT03400475|144228219|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1
72355256|NCT03400475|144228220|SUPERIORITY|||||||0.062|||||||Fisher Exact|||||||0.062
72355257|NCT03400475|144228221|SUPERIORITY|||||||0.54|||||||Fisher Exact|||||||0.54
72355258|NCT03400475|144228222|SUPERIORITY|||||||0.34|||||||Fisher Exact|||||||0.34
72355259|NCT02413918|144228227|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.9|STANDARD_DEVIATION|20.0|<|0.0094|TWO_SIDED|||||p value is not adjusted for multiple comparisons (see above). A priori threshold for significance was p\<0.05.|t-test, 2 sided|||BISS Outcomes: Mean changes in depression and mania for study completers were measured. The a priori hypothesis was a mean change of 50%.||||<0.0094
72355260|NCT02413918|144228227|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.4|STANDARD_DEVIATION|10.1|<|0.0001|TWO_SIDED||||||t-test, 2 sided|||BISS Outcomes: Mean changes in mania for study completers were measured. The a priori hypothesis was a mean change of 50%.||||<0.0001
72355261|NCT04233801|144228229|OTHER|"A restricted maximum likelihood (REML) based mixed model repeated measures (MMRM) approach was applied.The model included baseline value for the corresponding endpoint and its interaction with visit as additional covariates."|Adjusted mean|-0.99|||<|0.0001|TWO_SIDED|95.0|-1.28|-0.71|||Mixed model repeated measures|||||-0.71|-1.28|< 0.0001
72355262|NCT04233801|144228229|OTHER|"A restricted maximum likelihood (REML) based mixed model repeated measures (MMRM) approach was applied.The model included baseline value for the corresponding endpoint and its interaction with visit as additional covariates."|Adjusted mean|-0.98|||<|0.0001|TWO_SIDED|95.0|-1.26|-0.7|||Mixed model repeated measures|||||-0.70|-1.26|< 0.0001
72355263|NCT04233801|144228230|OTHER|Logistic regression including treatment, baseline Estimated glomerular filtration rate (eGFR), background therapy, and continuous baseline HbA1c.|Odds Ratio (OR)|2.29||||0.1375|TWO_SIDED|95.0|0.77|6.83|||Regression, Logistic|||||6.83|0.77|0.1375
72355264|NCT04233801|144228230|OTHER|Logistic regression including treatment, baseline Estimated glomerular filtration rate (eGFR), background therapy, and continuous baseline HbA1c.|Odds Ratio (OR)|6.01||||0.0008|TWO_SIDED|95.0|2.11|17.1|||Regression, Logistic|||||17.10|2.11|0.0008
72355265|NCT04233801|144228231|OTHER|"A restricted maximum likelihood (REML) based mixed model repeated measures (MMRM) approach was applied.The model included baseline value for the corresponding endpoint and its interaction with visit as additional covariates."|Adjusted mean|-2.0|||<|0.0001|TWO_SIDED|95.0|-2.66|-1.34|||Mixed model repeated measures|||||-1.34|-2.66|< 0.0001
72355266|NCT04233801|144228231|OTHER|"A restricted maximum likelihood (REML) based mixed model repeated measures (MMRM) approach was applied.The model included baseline value for the corresponding endpoint and its interaction with visit as additional covariates."|Adjusted mean|-1.32|||<|0.0001|TWO_SIDED|95.0|-1.96|-0.67|||Mixed model repeated measures|||||-0.67|-1.96|< 0.0001
72355267|NCT04233801|144228232|OTHER|"A restricted maximum likelihood (REML) based mixed model repeated measures (MMRM) approach was applied.The model included baseline value for the corresponding endpoint and its interaction with visit as additional covariates."|Adjusted mean|-3.6||||0.0774|TWO_SIDED|95.0|-7.61|0.4|||Mixed model repeated measures|||||0.40|-7.61|0.0774
72355268|NCT04233801|144228232|OTHER|"A restricted maximum likelihood (REML) based mixed model repeated measures (MMRM) approach was applied.The model included baseline value for the corresponding endpoint and its interaction with visit as additional covariates."|Adjusted mean|-1.01||||0.616|TWO_SIDED|95.0|-4.98|2.96|||Mixed model repeated measures|||||2.96|-4.98|0.6160
72355269|NCT04233801|144228233|OTHER|"A restricted maximum likelihood (REML) based mixed model repeated measures (MMRM) approach was applied.The model included baseline value for the corresponding endpoint and its interaction with visit as additional covariates."|Adjusted mean|-1.78||||0.1222|TWO_SIDED|95.0|-4.05|0.48|||Mixed model repeated measures|||||0.48|-4.05|0.1222
72355270|NCT04233801|144228233|OTHER|"A restricted maximum likelihood (REML) based mixed model repeated measures (MMRM) approach was applied.The model included baseline value for the corresponding endpoint and its interaction with visit as additional covariates."|Adjusted mean|0.65||||0.5687|TWO_SIDED|95.0|-1.59|2.89|||Mixed model repeated measures|||||2.89|-1.59|0.5687
72355271|NCT04233801|144228234|OTHER|"A restricted maximum likelihood (REML) based mixed model repeated measures (MMRM) approach was applied.The model included baseline value for the corresponding endpoint and its interaction with visit as additional covariates."|Adjusted mean|-20.05||||0.0003|TWO_SIDED|95.0|-30.73|-9.38|||Mixed model repeated measures|||||-9.38|-30.73|0.0003
72355272|NCT04233801|144228234|OTHER|"A restricted maximum likelihood (REML) based mixed model repeated measures (MMRM) approach was applied.The model included baseline value for the corresponding endpoint and its interaction with visit as additional covariates."|Adjusted mean|-24.13|||<|0.0001|TWO_SIDED|95.0|-34.72|-13.54|||Mixed model repeated measures|||||-13.54|-34.72|<0.0001
72355273|NCT04233801|144228235|OTHER|The Analysis of covariance (ANCOVA) model included treatment and background therapy as classification effects, baseline PPG and baseline Estimated glomerular filtration rate (eGFR) as the linear covariates.|Adjusted mean|-56.32|||<|0.0001|TWO_SIDED|95.0|-78.22|-34.41|||ANCOVA|||||-34.41|-78.22|<0.0001
72355274|NCT04233801|144228235|OTHER|The Analysis of covariance (ANCOVA) model included treatment and background therapy as classification effects, baseline PPG and baseline Estimated glomerular filtration rate (eGFR) as the linear covariates.|Adjusted mean|-60.71|||<|0.0001|TWO_SIDED|95.0|-82.31|-39.11|||ANCOVA|||||-39.11|-82.31|<0.0001
72355275|NCT04233801|144228236|OTHER||Odds Ratio (OR)|1.76||||0.2422|TWO_SIDED|95.0|0.68|4.55|||Regression, Logistic|Logistic regression including treatment and continuous baseline glycosylated haemoglobin A1c (HbA1c).|Odds ratio used Placebo as the reference group.|||4.55|0.68|0.2422
72355276|NCT04233801|144228236|OTHER||Odds Ratio (OR)|0.85||||0.7661|TWO_SIDED|95.0|0.29|2.5|||Regression, Logistic|Logistic regression including treatment and continuous baseline glycosylated haemoglobin A1c (HbA1c).|Odds ratio used Placebo as the reference group.|||2.50|0.29|0.7661
72355277|NCT01342913|144228241|SUPERIORITY_OR_OTHER||Least squares mean difference|0.022||||0.282|TWO_SIDED|95.0|-0.018|0.063|||ANCOVA|||||0.063|-0.018|0.282
72355278|NCT04024891|144228244|SUPERIORITY||Mean Difference (Net)|-1.0|||<|0.0001|TWO_SIDED|95.0|-1.3|-0.7|||Mixed Models Analysis|||||-0.7|-1.3|<0.0001
72355279|NCT02152631|144228269|SUPERIORITY||Hazard Ratio (HR)|0.968||||0.771|TWO_SIDED|95.0|0.768|1.219|||Stratified Log-Rank||Hazard Ratio (HR) was estimated based on Stratified Cox proportional hazard model.|The stratification factors used in the analysis were: number of prior chemotherapy regimens (1 versus 2), Eastern Cooperative Oncology Group (ECOG) Performance Score (PS) (0 versus 1), gender (male versus female), and kirsten rat sarcoma (KRAS) mutation (GLY12CYS \[G12C\] vs. all others)||1.219|0.768|0.771
72355280|NCT02152631|144228270|SUPERIORITY|||||||0.01|||||||Cochran-Mantel-Haenszel|||Stratified by number of prior chemotherapy regimens (1 versus 2), ECOG PS (0 versus 1), gender (male versus female), and KRAS mutation (GLY12CYS \[G12C\] vs. all others)||||0.010
72355281|NCT02152631|144228271|SUPERIORITY||Hazard Ratio (HR)|0.583|||<|1e-06|TWO_SIDED|95.0|0.47|0.723|||Stratified Log-Rank|||||0.723|0.470|<0.000001
72355282|NCT02152631|144228272|SUPERIORITY||LS Mean Change Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.19||0.698|TWO_SIDED|95.0|-0.44|0.29|||Mixed Models Analysis|Analyzed by Type 3 sums of squares, model covariates included Treatment + Visit + Treatment\*Visit + Baseline.||Headache||0.29|-0.44|0.698
72355283|NCT02152631|144228272|SUPERIORITY||LS Mean Change Difference|0.59|STANDARD_ERROR_OF_MEAN|0.28||0.038|TWO_SIDED|95.0|0.03|1.15|||Mixed Models Analysis|Analyzed by Type 3 sums of squares, model covariates included Treatment + Visit + Treatment\*Visit + Baseline.||Diarrhea||1.15|0.03|0.038
72355284|NCT02152631|144228272|SUPERIORITY||LS Mean Change Difference|-2.4|STANDARD_ERROR_OF_MEAN|0.27|<|0.001|TWO_SIDED|95.0|-2.94|-1.86|||Mixed Models Analysis|Analyzed by Type 3 sums of squares, model covariates included Treatment + Visit + Treatment\*Visit + Baseline.||Rash||-1.86|-2.94|<.001
72355285|NCT02152631|144228272|SUPERIORITY||LS Mean Change Difference|-0.24|STANDARD_ERROR_OF_MEAN|0.16||0.142|TWO_SIDED|95.0|-0.56|0.08|||Mixed Models Analysis|Analyzed by Type 3 sums of squares, model covariates included Treatment + Visit + Treatment\*Visit + Baseline.||Mean Core Symptom Severity||0.08|-0.56|0.142
72355286|NCT02152631|144228272|SUPERIORITY||LS Mean Change Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.23||0.514|TWO_SIDED|95.0|-0.59|0.3|||Mixed Models Analysis|Analyzed by Type 3 sums of square, model covariates included Treatment + Visit + Treatment\*Visit + Baseline.||Mean Interference||0.30|-0.59|0.514
72355287|NCT02152631|144228272|SUPERIORITY||LS Mean Change Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.15||0.646|TWO_SIDED|95.0|-0.37|0.23|||Mixed Models Analysis|Analyzed by Type 3 sums of squares, model covariates included Treatment + Visit + Treatment\*Visit + Baseline.||Mean Lung Cancer||0.23|-0.37|0.646
72355288|NCT02152631|144228272|SUPERIORITY||LS Mean Change Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.15||0.188|TWO_SIDED|95.0|-0.51|0.1|||Mixed Models Analysis|Analyzed by Type 3 sums of squares, model covariates included Treatment + Visit + Treatment\*Visit + Baseline.||Mean Core Plus Lung Cancer||0.10|-0.51|0.188
72429293|NCT04212169|144369563|SUPERIORITY||Odds Ratio (OR)|1.53||||0.6396|TWO_SIDED|90.0|0.19|9.94|||Fisher Exact||Odds ratio greater than 1 favours MEDI3506|||9.94|0.19|0.6396
72355289|NCT02152631|144228274|SUPERIORITY||LS Mean Change Difference|0.0|STANDARD_ERROR_OF_MEAN|0.02||0.951|TWO_SIDED|95.0|-0.05|0.05|||Mixed Models Analysis|Analyzed By Type 3 sums of squares, Change from Baseline = Treatment + Visit + Treatment\*Visit + Baseline.||||0.05|-0.05|0.951
72355290|NCT03776747|144228287|OTHER|Analysis of variance between lung inflation levels|||||<|0.001|||||||ANOVA|||We hypothesized that the anisotropic deformation index (ADC) is dependent upon lung inflation level. (Thus, it is important to standardize lung inflation when using this method)||||<0.001
72355291|NCT02210000|144228341|SUPERIORITY||Median Difference (Net)|-0.212||||0.017|TWO_SIDED|95.0|-0.3716|-0.0448||Posterior probability of the treatment difference in response rate at Week 12 being greater than 0%.|Bayesian method|||||-0.0448|-0.3716|0.017
72355292|NCT02210000|144228342|SUPERIORITY||Mean Difference (Net)|0.21|||||TWO_SIDED|95.0|-0.2353|0.6553|||||A negative difference indicated greater improvement in the Camicinal group compared to Placebo.|Nausea at Week 12. The least square means were the adjusted means which had been estimated with a mixed model using Baseline weekly average value, diabetes type, treatment, week and the interaction between treatment and week as fixed effects, participants as random effect and week as repeated effect.||0.6553|-0.2353|
72355293|NCT02210000|144228342|SUPERIORITY||Mean Difference (Net)|0.749|||||TWO_SIDED|95.0|0.2275|1.2705|||||A negative difference indicated greater improvement in the Camicinal group compared to Placebo.|Feeling full after meals at Week 12. The least square means were the adjusted means which had been estimated with a mixed model using Baseline weekly average value, diabetes type, treatment, week and the interaction between treatment and week as fixed effects, participants as random effect and week as repeated effect.||1.2705|0.2275|
72355294|NCT02210000|144228342|SUPERIORITY||Mean Difference (Net)|0.489|||||TWO_SIDED|95.0|-0.0592|1.0374|||||A negative difference indicated greater improvement in the Camicinal group compared to Placebo.|Bloating at Week 12. The least square means were the adjusted means which had been estimated with a mixed model using Baseline weekly average value, diabetes type, treatment, week and the interaction between treatment and week as fixed effects, participants as random effect and week as repeated effect.||1.0374|-0.0592|
72355295|NCT02210000|144228342|SUPERIORITY||Mean Difference (Net)|0.497|||||TWO_SIDED|95.0|0.0396|0.955|||||A negative difference indicated greater improvement in the Camicinal group compared to Placebo.|Not able to finish meal at Week 12. The least square means were the adjusted means which had been estimated with a mixed model using Baseline weekly average value, diabetes type, treatment, week and the interaction between treatment and week as fixed effects, participants as random effect and week as repeated effect.||0.9550|0.0396|
72355296|NCT02210000|144228342|SUPERIORITY||Mean Difference (Net)|0.05|||||TWO_SIDED|95.0|-0.3386|0.4395|||||A negative difference indicated greater improvement in the Camicinal group compared to Placebo.|Retching at Week 12. The least square means were the adjusted means which had been estimated with a mixed model using Baseline weekly average value, diabetes type, treatment, week and the interaction between treatment and week as fixed effects, participants as random effect and week as repeated effect.||0.4395|-0.3386|
72355297|NCT02210000|144228342|SUPERIORITY||Mean Difference (Net)|-0.038|||||TWO_SIDED|95.0|-0.3242|0.2492|||||A negative difference indicated greater improvement in the Camicinal group compared to Placebo.|Vomiting at Week 12. The least square means were the adjusted means which had been estimated with a mixed model using Baseline weekly average value, diabetes type, treatment, week and the interaction between treatment and week as fixed effects, participants as random effect and week as repeated effect.||0.2492|-0.3242|
72355298|NCT02210000|144228342|SUPERIORITY||Mean Difference (Net)|0.475|||||TWO_SIDED|95.0|-0.0483|0.9978|||||A negative difference indicated greater improvement in the Camicinal group compared to Placebo.|Stomach visibly larger at Week 12. The least square means were the adjusted means which had been estimated with a mixed model using Baseline weekly average value, diabetes type, treatment, week and the interaction between treatment and week as fixed effects, participants as random effect and week as repeated effect.||0.9978|-0.0483|
72429294|NCT04212169|144369563|SUPERIORITY||Odds Ratio (OR)|0.76||||0.9999|TWO_SIDED|90.0|0.03|6.38|||Fisher Exact||Odds ratio greater than 1 favours MEDI3506|||6.38|0.03|0.9999
72355299|NCT02210000|144228342|SUPERIORITY||Mean Difference (Net)|0.461|||||TWO_SIDED|95.0|-0.0519|0.9748|||||A negative difference indicated greater improvement in the Camicinal group compared to Placebo.|Stomach fullness at Week 12. The least square means were the adjusted means which had been estimated with a mixed model using Baseline weekly average value, diabetes type, treatment, week and the interaction between treatment and week as fixed effects, participants as random effect and week as repeated effect.||0.9748|-0.0519|
72355300|NCT02210000|144228342|SUPERIORITY||Mean Difference (Net)|0.536|||||TWO_SIDED|95.0|0.0967|0.9745|||||A negative difference indicated greater improvement in the Camicinal group compared to Placebo.|Loss of appetite at Week 12. The least square means were the adjusted means which had been estimated with a mixed model using Baseline weekly average value, diabetes type, treatment, week and the interaction between treatment and week as fixed effects, participants as random effect and week as repeated effect.||0.9745|0.0967|
72355301|NCT02210000|144228342|SUPERIORITY||Mean Difference (Net)|0.196|||||TWO_SIDED|95.0|-0.2746|0.6671|||||A negative difference indicated greater improvement in the Camicinal group compared to Placebo.|Upper abdominal pain at Week 12. The least square means were the adjusted means which had been estimated with a mixed model using Baseline weekly average value, diabetes type, treatment, week and the interaction between treatment and week as fixed effects, participants as random effect and week as repeated effect.||0.6671|-0.2746|
72355302|NCT02210000|144228342|SUPERIORITY||Mean Difference (Net)|0.314|||||TWO_SIDED|95.0|-0.2013|0.8292|||||A negative difference indicated greater improvement in the Camicinal group compared to Placebo.|Upper abdominal discomfort at Week 12. The least square means were the adjusted means which had been estimated with a mixed model using Baseline weekly average value, diabetes type, treatment, week and the interaction between treatment and week as fixed effects, participants as random effect and week as repeated effect.||0.8292|-0.2013|
72355303|NCT02210000|144228342|SUPERIORITY||Mean Difference (Net)|0.384|||||TWO_SIDED|95.0|-0.0323|0.7997|||||A negative difference indicated greater improvement in the Camicinal group compared to Placebo.|Overall severity of your GP symptoms at Week 12. The least square means were the adjusted means which had been estimated with a mixed model using Baseline weekly average value, diabetes type, treatment, week and the interaction between treatment and week as fixed effects, participants as random effect and week as repeated effect.||0.7997|-0.0323|
72355304|NCT02210000|144228342|SUPERIORITY||Mean Difference (Net)|0.068|||||TWO_SIDED|95.0|-0.2366|0.3723|||||A negative difference indicated greater improvement in the Camicinal group compared to Placebo.|Nausea/Vomiting Subscale at Week 12. The least square means were the adjusted means which had been estimated with a mixed model using Baseline weekly average value, diabetes type, treatment, week and the interaction between treatment and week as fixed effects, participants as random effect and week as repeated effect.||0.3723|-0.2366|
72355305|NCT02210000|144228342|SUPERIORITY||Mean Difference (Net)|0.548|||||TWO_SIDED|95.0|0.1333|0.9628|||||A negative difference indicated greater improvement in the Camicinal group compared to Placebo.|Fullness/Early Satiety Subscale at Week 12. The least square means were the adjusted means which had been estimated with a mixed model using Baseline weekly average value, diabetes type, treatment, week and the interaction between treatment and week as fixed effects, participants as random effect and week as repeated effect.||0.9628|0.1333|
72355306|NCT02210000|144228342|SUPERIORITY||Mean Difference (Net)|0.479|||||TWO_SIDED|95.0|-0.0386|0.9966|||||A negative difference indicated greater improvement in the Camicinal group compared to Placebo.|Bloating Subscale at Week 12. The least square means were the adjusted means which had been estimated with a mixed model using Baseline weekly average value, diabetes type, treatment, week and the interaction between treatment and week as fixed effects, participants as random effect and week as repeated effect.||0.9966|-0.0386|
72355307|NCT02210000|144228342|SUPERIORITY||Mean Difference (Net)|0.356|||||TWO_SIDED|95.0|-0.0049|0.7179|||||A negative difference indicated greater improvement in the Camicinal group compared to Placebo.|Total GCSI-DD at Week 12. The least square means were the adjusted means which had been estimated with a mixed model using Baseline weekly average value, diabetes type, treatment, week and the interaction between treatment and week as fixed effects, participants as random effect and week as repeated effect.||0.7179|-0.0049|
72355308|NCT00308139|144228371|NON_INFERIORITY_OR_EQUIVALENCE|The choice of a 0.4% noninferiority margin was resulted from the considerations of expected clinical benefit of BYETTA in this study based on clinical data evaluating exenatide LAR and BYETTA, regulatory guidance, published literature, and statistical considerations.|Least Squares Mean Difference|-0.33|STANDARD_ERROR_OF_MEAN|0.107||0.0023|TWO_SIDED|95.0|-0.54|-0.12|||ANOVA|Analysis of variance (ANOVA) model includes treatment, baseline HbA1c stratum (\<9% or \>=9%), and concomitant SU use at screening as factors.||Superiority of exenatide long-acting release (LAR) once weekly to BYETTA if the upper limit of the 2-sided 95% confidence interval (CI) for treatment difference (LAR minus BYETTA) is less than 0; non-inferiority if this upper limit is less than 0.4%. Power:Assuming 20% dropout rate with 246 subjects will complete the study. This sample size would provide 90% power for non-inferiority test with assumption of greater reduction (0.1%) in LAR and a common standard deviation of 1.2%.||-0.12|-0.54|0.0023
72355309|NCT00308139|144228374|SUPERIORITY_OR_OTHER|||||||0.0003|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Analysis: Percentages of subjects achieving HbA1c target value of \<7% at Week 30 were compared between treatments using a Cochran-Mantel-Haenszel (CMH) test, in which baseline HbA1c stratum (\<9% or \>=9%) and concomitant SU use at screening served as the stratification factors. Null hypothesis: no difference between treatments in percentage of subjects achieving HbA1c target. Power: based on the primary measurement.||||0.0003
72355310|NCT00308139|144228376|SUPERIORITY_OR_OTHER|||||||0.2042|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Analysis: Percentage of subjects achieving HbA1c target value of \<=6.5% at Week 30 were compared between treatments using CMH test, in which baseline HbA1c stratum (\<9% or \>=9%) and concomitant SU use at screening served as the stratification factors. Null hypothesis: no difference between treatments in percentage of subjects achieving HbA1c target. Power: based on the primary measurement.||||0.2042
72355311|NCT00308139|144228378|SUPERIORITY_OR_OTHER|||||||0.1513|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Analysis: Percentages of subjects achieving HbA1c target values of \<=6.0% at Week 30 were compared between treatments using CMH test, in which baseline HbA1c stratum (\<9% or \>=9%) and concomitant SU use at screening served as the stratification factors. Null hypothesis: no difference between treatments in percentage of subjects achieving HbA1c target. Power: based on the primary measurement.||||0.1513
72429295|NCT04212169|144369563|SUPERIORITY||Odds Ratio (OR)|2.89||||0.0935|TWO_SIDED|90.0|0.91|10.49|||Regression, Logistic||Odds ratio greater than 1 favours MEDI3506|||10.49|0.91|0.0935
72355312|NCT00308139|144228380|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|30.08|STANDARD_ERROR_OF_MEAN|11.458||0.0124|TWO_SIDED|95.0|6.88|53.28|||ANCOVA|||Analysis: Change in 2h postprandial glucose from baseline (Day -3) to Week 14 was analyzed using an ANCOVA model including treatment, baseline HbA1c stratum (\<9% or \>=9%), and concomitant SU use at screening as factors, and baseline value of the 2h postprandial glucose as a covariate. Null hypothesis: no difference between treatments in change from baseline 2h postprandial glucose.||53.28|6.88|0.0124
72355313|NCT00308139|144228382|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.612||0.8916|TWO_SIDED|95.0|-1.29|1.12|||ANCOVA|||Analysis: Change in body weight from baseline (Day -3) to Week 30 was analyzed using an analysis of covariance (ANCOVA) model including treatment, baseline HbA1c stratum (\<9% or \>=9%), and concomitant SU use at screening as factors, and baseline value of the body weight as a covariate. Null hypothesis: no difference between treatments in change from baseline body weight. Power: based on the primary measurement.||1.12|-1.29|0.8916
72355314|NCT00308139|144228384|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-16.9|STANDARD_ERROR_OF_MEAN|3.8|<|0.0001|TWO_SIDED|95.0|-24.4|-9.4|||ANCOVA|||Analysis: Change in fasting plasma glucose from baseline (Day -3) to Week 30 was analyzed using an ANCOVA model including treatment, baseline HbA1c stratum (\<9% or \>=9%), and concomitant SU use at screening as factors, and baseline value of the fasting plasma glucose as a covariate. Null hypothesis: no difference between treatments in change from baseline fasting plasma glucose. Power: based on the primary measurement.||-9.4|-24.4|<.0001
72355315|NCT00308139|144228388|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-8.2|STANDARD_ERROR_OF_MEAN|3.04||0.0077|TWO_SIDED|95.0|-14.1|-2.2|||ANCOVA|||Analysis: Change in total cholesterol from baseline (Day -3) to Week 30 was analyzed using an ANCOVA model including treatment, baseline HbA1c stratum (\<9% or \>=9%), and concomitant SU use at screening as factors, and baseline value of the total cholesterol as a covariate. Null hypothesis: no difference between treatments in change from baseline total cholesterol. Power: based on the primary measurement.||-2.2|-14.1|0.0077
72355316|NCT00308139|144228390|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.4|STANDARD_ERROR_OF_MEAN|0.74||0.5613|TWO_SIDED|95.0|-1.0|1.9|||ANCOVA|||Analysis: Change in HDL-C from baseline (Day -3) to Week 30 was analyzed using an ANCOVA model including treatment, baseline HbA1c stratum (\<9% or \>=9%), and concomitant SU use at screening as factors, and baseline value of the HDL as a covariate. Null hypothesis: no difference between treatments in change from baseline HDL. Power: based on the primary measurement.||1.9|-1.0|0.5613
72355317|NCT00308139|144228393|SUPERIORITY_OR_OTHER||Geometic Least Squares Mean Ratio|0.95|STANDARD_ERROR_OF_MEAN|0.042||0.2915|TWO_SIDED|95.0|0.87|1.04|||ANCOVA|||Analysis: Triglycerides data were logarithm-transformed and the change at Week 30 to baseline (Day -3), expressed as the ratio, was analyzed by an ANCOVA model including treatment, baseline HbA1c stratum (\<9% or \>=9%), and concomitant SU use at screening as factors, and baseline value of the triglycerides as a covariate. Null hypothesis: no difference between treatments in change from baseline triglycerides. Power: based on the primary measurement.||1.04|0.87|0.2915
72355318|NCT00833040|144228399|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|17.3|STANDARD_ERROR_OF_MEAN|4.49|<|0.001||95.0|||||ANCOVA|||difference between the active and placebo groups||||<0.001
72355319|NCT03489863|144228403|NON_INFERIORITY|see above|Mean Difference (Net)|-18.0|||<|0.05|TWO_SIDED|95.0|-38.0|2.0|||ANCOVA|||The primary endpoint is non-inferiority in PRU, at 24 hours of prasugrel versus ticagrelor. Under the assumption of 0 difference at 24 hours in mean PRU between ticagrelor and prasugrel and a common standard deviation of 50 PRU, a sample size of 22 patients per group allows for the 95% CI to stay within ± 45 PRU with a 90% power and alpha = 0.05.||2|-38|<0.05
72355320|NCT00867165|144228427|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-squares means|-26.74|||<|0.001|TWO_SIDED|95.0|-30.8|-22.69|||ANCOVA|||||-22.69|-30.80|<0.001
72429296|NCT04212169|144369565|SUPERIORITY||Odds Ratio (OR)|3.06||||0.445|TWO_SIDED|90.0|0.08|119.65|||Fisher Exact||Odds ratio greater than one favour MEDI3506|||119.65|0.08|0.4450
72355321|NCT00867165|144228428|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-squares means|-20.92|||<|0.001|TWO_SIDED|95.0|-24.2|-17.65|||ANCOVA|||||-17.65|-24.20|<0.001
72355322|NCT00867165|144228429|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-squares means|-20.24|||<|0.001|TWO_SIDED|95.0|-24.02|-16.45|||ANCOVA|||||-16.45|-24.02|<0.001
72355323|NCT00867165|144228430|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-square means|0.7||||0.807|TWO_SIDED|95.0|-4.97|6.36|||ANCOVA|||||6.36|-4.97|0.807
72355324|NCT00867165|144228431|SUPERIORITY_OR_OTHER_LEGACY||Differrence in least-squares means|-25.75|||<|0.001|TWO_SIDED|95.0|-29.59|-21.91|||ANCOVA|||||-21.91|-29.59|<0.001
72355325|NCT00867165|144228432|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-square means|-14.68||||0.021|TWO_SIDED|95.0|-27.35|-2.0|||Constrained longitudinal data analysis|||||-2.00|-27.35|0.021
72355326|NCT00867165|144228433|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-squares means|-24.97|||<|0.001|TWO_SIDED|95.0|-28.95|-20.99|||ANCOVA|||||-20.99|-28.95|<0.001
72355327|NCT00867165|144228434|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-square means|-23.94|||<|0.001|TWO_SIDED|95.0|-27.49|-20.39|||ANCOVA|||||-20.39|-27.49|<0.001
72355328|NCT00867165|144228435|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-squares means|-27.71|||<|0.001|TWO_SIDED|95.0|-31.7|-23.73|||ANCOVA|||||-23.73|-31.70|<0.001
72355329|NCT00867165|144228436|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-squares means|-20.09|||<|0.001|TWO_SIDED|95.0|-23.3|-16.89|||ANCOVA|||||-16.89|-23.30|<0.001
72355330|NCT00867165|144228437|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-squares means|-20.27|||<|0.001|TWO_SIDED|95.0|-23.39|-17.15|||ANCOVA|||||-17.15|-23.39|<0.001
72355331|NCT00867165|144228438|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-squares means|-21.37|||<|0.001|TWO_SIDED|95.0|-24.67|-18.08|||ANCOVA|||||-18.08|-24.67|<0.001
72355332|NCT00867165|144228439|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-squares means|-0.95||||0.733|TWO_SIDED|95.0|-6.46|4.55|||ANCOVA|||||4.55|-6.46|0.733
72355333|NCT00867165|144228440|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-squares means|0.53||||0.863|TWO_SIDED|95.0|-5.59|6.66|||ANCOVA|||||6.66|-5.59|0.863
72355334|NCT00867165|144228441|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-squares means|1.92||||0.501|TWO_SIDED|95.0|-3.71|7.56|||ANCOVA|||||7.56|-3.71|0.501
72429297|NCT04212169|144369565|SUPERIORITY||Odds Ratio (OR)|0.0||||0.9999|TWO_SIDED|90.0|0.0|28.0|||Fisher Exact||Odds ratio greater than 1 favours MEDI3506|||28.0|0.0|0.9999
72429298|NCT04212169|144369565|SUPERIORITY||Odds Ratio (OR)|5.5||||0.1132|TWO_SIDED|90.0|0.75|130.35|||Fisher Exact||Odds ratio greater than 1 favours MEDI3506|||130.35|0.75|0.1132
72355335|NCT00867165|144228442|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-squares means|-24.18|||<|0.001|TWO_SIDED|95.0|-27.78|-20.58|||ANCOVA|||||-20.58|-27.78|<0.001
72355336|NCT00867165|144228443|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-squares means|-24.61|||<|0.001|TWO_SIDED|95.0|-28.06|-21.16|||ANCOVA|||||-21.16|-28.06|<0.001
72355337|NCT00867165|144228444|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-squares means|-26.55|||<|0.001|TWO_SIDED|95.0|-30.35|-22.75|||ANCOVA|||||-22.75|-30.35|<0.001
72355338|NCT00867165|144228445|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-squares means|-9.73||||0.137|TWO_SIDED|95.0|-22.73|3.27|||Constrained longitudinal data analysis|||||3.27|-22.73|0.137
72355339|NCT00867165|144228446|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-squares means|-15.19||||0.005|TWO_SIDED|95.0|-26.05|-4.34|||Constrained longitudinal data analysis|||||-4.34|-26.05|0.005
72355340|NCT00867165|144228447|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-squares means|-8.61||||0.149|TWO_SIDED|95.0|-20.44|3.23|||Constrained longitudinal data analysis|||||3.23|-20.44|0.149
72355341|NCT00867165|144228448|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-squares means|-1.91||||0.373|TWO_SIDED|95.0|-6.15|2.32|||ANCOVA|||||2.32|-6.15|0.373
72355342|NCT00867165|144228449|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least-squares mean|-19.76|||<|0.001|TWO_SIDED|95.0|-24.7|-14.82|||ANCOVA|||||-14.82|-24.70|<0.001
72355343|NCT00867165|144228450|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-squares means|-20.83|||<|0.001|TWO_SIDED|95.0|-25.59|-16.07|||ANCOVA|||||-16.07|-25.59|<0.001
72355344|NCT00867165|144228451|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-squares means|-23.48|||<|0.001|TWO_SIDED|95.0|-29.0|-17.97|||ANCOVA|||||-17.97|-29.00|<0.001
72355345|NCT00867165|144228452|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-squares means|-22.29|||<|0.001|TWO_SIDED|95.0|-27.25|-17.34|||ANCOVA|||||-17.34|-27.25|<0.001
72355346|NCT00867165|144228453|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-squares means|-24.5|||<|0.001|TWO_SIDED|95.0|-29.88|-19.12|||ANCOVA|||||-19.12|-29.88|<0.001
72355347|NCT00867165|144228454|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-squares means|-25.15|||<|0.001|TWO_SIDED|95.0|-30.69|-19.62|||ANCOVA|||||-19.62|-30.69|<0.001
72355348|NCT00867165|144228455|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-squares means|-29.31|||<|0.001|TWO_SIDED|95.0|-35.71|-22.91|||ANCOVA|||||-22.91|-35.71|<0.001
72355349|NCT00867165|144228456|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-squares means|-28.35|||<|0.001|TWO_SIDED|95.0|-34.41|-22.29|||ANCOVA|||||-22.29|-34.41|<0.001
72355350|NCT00867165|144228457|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-squares means|-19.28|||<|0.001|TWO_SIDED|95.0|-23.87|-14.7|||ANCOVA|||||-14.70|-23.87|<0.001
72355351|NCT00867165|144228458|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-squares means|-46.11||||0.116|TWO_SIDED|95.0|-108.14|15.92|||Constrained longitudinal data analysis|||||15.92|-108.14|0.116
72355352|NCT00867165|144228459|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-squares means|17.27||||0.382|TWO_SIDED|95.0|-20.46|55.0|||Constrained longitudinal data analysis|||||55.00|-20.46|0.382
72355353|NCT00867165|144228460|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-squares means|-49.61|||<|0.001|TWO_SIDED|95.0|-55.36|-43.87|||ANCOVA|||||-43.87|-55.36|<0.001
72355354|NCT00867165|144228461|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-squares means|-58.52|||<|0.001|TWO_SIDED|95.0|-63.67|-53.38|||ANCOVA|||||-53.38|-63.67|<0.001
72355355|NCT00867165|144228462|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-squares means|-61.02|||<|0.001|TWO_SIDED|95.0|-67.51|-54.53|||ANCOVA|||||-54.53|-67.51|<0.001
72355356|NCT00867165|144228463|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-squares means|-62.74||||0.001|TWO_SIDED|95.0|-73.22|-52.26|||ANCOVA|||||-52.26|-73.22|0.001
72355357|NCT00867165|144228464|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-squares means|-49.48|||<|0.001|TWO_SIDED|95.0|-54.83|-44.14|||ANCOVA|||||-44.14|-54.83|<0.001
72355358|NCT00867165|144228465|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-squares means|-57.99|||<|0.001|TWO_SIDED|95.0|-62.87|-53.11|||ANCOVA|||||-53.11|-62.87|<0.001
72355359|NCT00867165|144228466|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-squares means|-62.6|||<|0.001|TWO_SIDED|95.0|-68.54|-56.66|||ANCOVA|||||-56.66|-68.54|<0.001
72355360|NCT00867165|144228467|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-squares means|-64.67|||<|0.001|TWO_SIDED|95.0|-74.11|-55.23|||ANCOVA|||||-55.23|-74.11|<0.001
72355361|NCT00867165|144228468|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-squares means|-18.35|||<|0.001|TWO_SIDED|95.0|-24.7|-11.99|||ANCOVA|||||-11.99|-24.70|<0.001
72355362|NCT00867165|144228469|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-squares means|-25.61|||<|0.001|TWO_SIDED|95.0|-31.2|-20.02|||ANCOVA|||||-20.02|-31.20|<0.001
72355363|NCT00867165|144228470|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-squares means|-28.74|||<|0.001|TWO_SIDED|95.0|-34.89|-22.59|||ANCOVA|||||-22.59|-34.89|<0.001
72355364|NCT00867165|144228471|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-squares means|-32.14|||<|0.001|TWO_SIDED|95.0|-40.38|-23.9|||ANCOVA|||||-23.90|-40.38|<0.001
72355365|NCT00867165|144228472|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-squares means|20.01||||0.001|TWO_SIDED|95.0|8.1|31.91|||ANCOVA|||||31.91|8.10|0.001
72355366|NCT00867165|144228473|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-squares means|26.29|||<|0.001|TWO_SIDED|95.0|13.99|38.58|||ANCOVA|||||38.58|13.99|<0.001
72355367|NCT00867165|144228474|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-squares means|36.7|||<|0.001|TWO_SIDED|95.0|24.12|49.28|||ANCOVA|||||49.28|24.12|<0.001
72355368|NCT00867165|144228475|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-squares means|24.05|||<|0.001|TWO_SIDED|95.0|10.43|37.67|||ANCOVA|||||37.67|10.43|<0.001
72355369|NCT01506271|144228481|NON_INFERIORITY|Non-inferiority test based on unconditional asymptotic Miettinen and Nurminen method without stratification.|Percentage Difference|1.1|||<|0.001|TWO_SIDED|95.0|-6.2|8.6|||Miettinen and Nurminen||Relebactam minus Placebo|MK-7655 250 mg - Placebo: Percentage Difference||8.6|-6.2|< 0.001
72355370|NCT01506271|144228481|NON_INFERIORITY|Non-inferiority test based on unconditional asymptotic Miettinen and Nurminen method without stratification.|Percentage Difference|3.7|||<|0.001|TWO_SIDED|95.0|-2.0|10.8|||Miettinen and Nurminen||Relebactam minus Placebo|Relebactam 125 mg - Placebo: Percentage Difference||10.8|-2.0|< 0.001
72355371|NCT01506271|144228482|OTHER|Test for a non-zero difference.|Percentage Difference|0.0||||0.979|TWO_SIDED|95.0|-4.7|4.5|||Miettinen and Nurminen||Relebactam minus Placebo|Relebactam 250 mg - Placebo: Percentage Difference||4.5|-4.7|0.979
72429299|NCT05454449|144369596|OTHER|||||||0.047|||||||t-test, 2 sided|||||||0.047
72355372|NCT01506271|144228482|OTHER|Test for a non-zero difference.|Percentage Difference|-1.8||||0.153|TWO_SIDED|95.0|-6.2|1.5|||Miettinen and Nurminen||Relebactam minus Placebo|Relebactam 125 mg - Placebo: Percentage Difference||1.5|-6.2|0.153
72355373|NCT01506271|144228483|OTHER|Test for a non-zero difference.|Percentage Difference|0.9||||0.324|TWO_SIDED|95.0|-2.4|4.7|||Miettinen and Nurminen||Relebactam minus Placebo|Relebactam 250 mg - Placebo: Percentage Difference||4.7|-2.4|0.324
72355374|NCT01506271|144228483|OTHER|Test for a non-zero difference|Percentage Difference|0.0|||>|0.999|TWO_SIDED|95.0|-3.3|3.2|||Miettinen and Nurminen||Relebactam minus Placebo|Relebactam 125 mg - Placebo: Percentage Difference||3.2|-3.3|> 0.999
72355375|NCT01506271|144228484|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|7.5|||||TWO_SIDED|95.0|-5.4|20.1|||||Relebactam minus Placebo|Relebactam 250 mg - Placebo: Percentage Difference||20.1|-5.4|
72355376|NCT01506271|144228484|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|6.2|||||TWO_SIDED|95.0|-6.7|18.8|||||Relebactam minus Placebo|Relebactam 125 mg - Placebo: Percentage Difference||18.8|-6.7|
72355377|NCT01506271|144228485|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|-3.6|||||TWO_SIDED|95.0|-10.3|2.4|||||Relebactam minus Placebo|Relebactam 250 mg - Placebo: Percentage Difference||2.4|-10.3|
72355378|NCT01506271|144228485|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|2.5|||||TWO_SIDED|95.0|-5.0|10.1|||||Relebactam minus Placebo|Relebactam 125 mg - Placebo: Percentage Difference||10.1|-5.0|
72355379|NCT01506271|144228486|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|4.0|||||TWO_SIDED|95.0|-4.5|12.7|||||Relebactam minus Placebo|Relebactam 250 mg - Placebo: Percentage Difference||12.7|-4.5|
72355380|NCT01506271|144228486|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|4.1|||||TWO_SIDED|95.0|-4.4|12.8|||||Relebactam minus Placebo|Relebactam 125 mg - Placebo: Percentage Difference||12.8|-4.4|
72429300|NCT05454449|144369597|OTHER|||||||0.009|||||||t-test, 2 sided|||||||0.009
72355381|NCT01506271|144228487|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|0.0|||||TWO_SIDED|95.0|-4.0|3.9|||||Relebactam minus Placebo|Relebactam 250 mg - Placebo: Percentage Difference||3.9|-4.0|
72355382|NCT01506271|144228487|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification.|Percentage Difference|-0.9|||||TWO_SIDED|95.0|-4.8|2.4|||||Relebactam minus Placebo|Relebactam 125 mg - Placebo: Percentage Difference||2.4|-4.8|
72355383|NCT01506271|144228488|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|-1.8|||||TWO_SIDED|95.0|-6.7|2.3|||||Relebactam minus Placebo|Relebactam 250 mg - Placebo: Percentage Difference||2.3|-6.7|
72355384|NCT01506271|144228488|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|1.7|||||TWO_SIDED|95.0|-3.7|7.4|||||Relebactam minus Placebo|Relebactam 125 mg - Placebo: Percentage Difference||7.4|-3.7|
72355385|NCT01506271|144228489|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|-2.6|||||TWO_SIDED|95.0|-7.5|0.6|||||Relebactam minus Placebo|Relebactam 250 mg - Placebo: Percentage Difference||0.6|-7.5|
72355386|NCT01506271|144228489|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification.|Percentage Difference|-1.8|||||TWO_SIDED|95.0|-6.7|2.4|||||Relebactam minus Placebo|Relebactam 125 mg - Placebo: Percentage Difference||2.4|-6.7|
72355387|NCT01506271|144228490|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|1.6|||||TWO_SIDED|95.0|-4.7|8.1|||||Relebactam minus Placebo|Relebactam 250 mg - Placebo: Percentage Difference - Diarrhoea||8.1|-4.7|
72355388|NCT01506271|144228490|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|1.6|||||TWO_SIDED|95.0|-4.6|8.2|||||Relebactam minus Placebo|Relebactam 125 mg - Placebo: Percentage Difference - Diarrhoea||8.2|-4.6|
72355389|NCT01506271|144228490|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|-0.2|||||TWO_SIDED|95.0|-7.3|6.9|||||Relebactam minus Placebo|Relebactam 250 mg - Placebo: Percentage Difference - Nausea||6.9|-7.3|
72355390|NCT01506271|144228490|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|0.7|||||TWO_SIDED|95.0|-6.5|8.0|||||Relebactam minus Placebo|Relebactam 125 mg - Placebo: Percentage Difference - Nausea||8.0|-6.5|
72355391|NCT01506271|144228490|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|3.4|||||TWO_SIDED|95.0|-2.3|9.6|||||Relebactam minus Placebo|Relebactam 250 mg - Placebo: Percentage Difference - Vomiting||9.6|-2.3|
72355392|NCT01506271|144228490|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|5.1|||||TWO_SIDED|95.0|-0.7|11.8|||||Relebactam minus Placebo|Relebactam 125 mg - Placebo: Percentage Difference - Vomiting||11.8|-0.7|
72355393|NCT01506271|144228490|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|-1.8|||||TWO_SIDED|95.0|-7.6|3.5|||||Relebactam minus Placebo|Relebactam 250 mg - Placebo: Percentage Difference - Postoperative Infection||3.5|-7.6|
72355394|NCT01506271|144228490|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|-2.7|||||TWO_SIDED|95.0|-8.4|2.2|||||Relebactam minus Placebo|Relebactam 125 mg - Placebo: Percentage Difference - Postoperative Infection||2.2|-8.4|
72355395|NCT01506271|144228490|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|0.9|||||TWO_SIDED|95.0|-2.4|4.7|||||Relebactam minus Placebo|Relebactam 250 mg - Placebo: Percentage Difference - Seroma||4.7|-2.4|
72355396|NCT01506271|144228490|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|4.3|||||TWO_SIDED|95.0|1.0|9.7|||||Relebactam minus Placebo|Relebactam 125 mg - Placebo: Percentage Difference - Seroma||9.7|1.0|
72355397|NCT01506271|144228490|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|0.8|||||TWO_SIDED|95.0|-5.0|6.6|||||Relebactam minus Placebo|Relebactam 250 mg - Placebo: Percentage Difference - ALT increased||6.6|-5.0|
72429301|NCT05454449|144369598|OTHER|||||||0.082|||||||t-test, 2 sided|||||||0.082
72429302|NCT05454449|144369599|OTHER|||||||0.022|||||||t-test, 2 sided|||||||0.022
72429303|NCT05454449|144369600|OTHER|||||||0.016|||||||t-test, 2 sided|||||||0.016
72429304|NCT05454449|144369601|OTHER|||||||0.029|||||||t-test, 2 sided|||||||0.029
72429305|NCT05454449|144369602|OTHER|||||||0.007|||||||t-test, 2 sided|||||||0.007
72355398|NCT01506271|144228490|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|0.8|||||TWO_SIDED|95.0|-4.9|6.7|||||Relebactam minus Placebo|Relebactam 125 mg - Placebo: Percentage Difference - ALT increased||6.7|-4.9|
72355399|NCT01506271|144228490|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|1.6|||||TWO_SIDED|95.0|-3.7|7.3|||||Relebactam minus Placebo|Relebactam 250 mg - Placebo: Percentage Difference - AST increased||7.3|-3.7|
72355400|NCT01506271|144228490|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|1.7|||||TWO_SIDED|95.0|-3.7|7.4|||||Relebactam minus Placebo|Relebactam 125 mg - Placebo: Percentage Difference - AST increased||7.4|-3.7|
72355401|NCT01506271|144228490|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|-0.9|||||TWO_SIDED|95.0|-6.5|4.2|||||Relebactam minus Placebo|Relebactam 250 mg - Placebo: Percentage Difference - Lipase increased||4.2|-6.5|
72355402|NCT01506271|144228490|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|-1.8|||||TWO_SIDED|95.0|-7.2|3.0|||||Relebactam minus Placebo|Relebactam 125 mg - Placebo: Percentage Difference - Lipase increased||3.0|-7.2|
72355403|NCT01506271|144228490|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|-3.5|||||TWO_SIDED|95.0|-8.7|-0.3|||||Relebactam minus Placebo|Relebactam 250 mg - Placebo: Percentage Difference - Hypertension||-0.3|-8.7|
72355404|NCT01506271|144228490|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|-0.9|||||TWO_SIDED|95.0|-6.4|4.3|||||Relebactam minus Placebo|Relebactam 125 mg - Placebo: Percentage Difference - Hypertension||4.3|-6.4|
72355405|NCT01506271|144228491|SUPERIORITY||Percentage Difference|0.0|||>|0.999|TWO_SIDED|95.0|0.0|0.0|||Fisher Exact||Relebactam minus Placebo|Relebactam 250 mg - Placebo: Percentage Difference||0|0|> 0.999
72355406|NCT01506271|144228491|SUPERIORITY||Percentage Difference|0.0|||>|0.999|TWO_SIDED|95.0|0.0|0.0|||Fisher Exact||Relebactam minus Placebo|Relebactam 125 mg - Placebo: Percentage Difference||0|0|> 0.999
72429306|NCT03123263|144369614|OTHER|Repeated measures one sided ANOVA was used to analyze changes in ejection fraction over time.|||||<|0.0005|||||||ANOVA|F (2,98) =13.974||||||<0.0005
72355407|NCT01506271|144228492|NON_INFERIORITY|Unconditional asymptotic Miettinen and Nurminen method without stratification.|Percentage Difference|-1.4||||0.001|TWO_SIDED|95.0|-9.1|6.0|||Miettinen and Nurminen||Relebactam minus Placebo|Relebactam 250 mg - Placebo: Percentage Difference||6.0|-9.1|0.001
72355408|NCT01506271|144228492|NON_INFERIORITY|Unconditional asymptotic Miettinen and Nurminen method without stratification.|Percentage Difference|-2.1||||0.002|TWO_SIDED|95.0|-9.7|5.3|||Miettinen and Nurminen||Relebactam minus Placebo|Relebactam 125 mg - Placebo: Percentage Difference||5.3|-9.7|0.002
72355409|NCT01506271|144228493|NON_INFERIORITY|Two participants with indeterminate or missing response were excluded from the analysis.|Percentage Difference|0.0|||<|0.001|TWO_SIDED|95.0|-6.3|6.2|||Miettinen and Nurminen||Relebactam minus Placebo|Relebactam 250 mg - Placebo: Percentage Difference||6.2|-6.3|< 0.001
72355410|NCT01506271|144228493|NON_INFERIORITY|Two participants with indeterminate or missing response were excluded from the analysis.|Percentage Difference|2.4|||<|0.001|TWO_SIDED|95.0|-2.0|8.3|||Miettinen and Nurminen||Relebactam minus Placebo|Relebactam 125 mg - Placebo: Percentage Difference||8.3|-2.0|< 0.001
72355411|NCT01506271|144228494|NON_INFERIORITY|Eight participants with indeterminate or missing response were excluded from the analysis.|Percentage Difference|-0.1|||<|0.001|TWO_SIDED|95.0|-6.7|6.4|||Miettinen and Nurminen||Relebactam minus Placebo|Relebactam 250 mg - Placebo: Percentage Difference||6.4|-6.7|< 0.001
72355412|NCT01506271|144228494|NON_INFERIORITY|Eight participants with indeterminate or missing response were excluded from the analysis.|Percentage Difference|0.1|||<|0.001|TWO_SIDED|95.0|-6.3|6.5|||Miettinen and Nurminen||Relebactam minus Placebo|Relebactam 125 mg - Placebo: Percentage Difference||6.5|-6.3|< 0.001
72355413|NCT01506271|144228495|NON_INFERIORITY|Non-inferiority test based on Unconditional asymptotic Miettinen and Nurminen method without stratification.|Percentage Difference|-1.3||||0.002|TWO_SIDED|95.0|-9.6|6.9|||Miettinen and Nurminen||Relebactam minus Placebo|Relebactam 250 mg - Placebo: Percentage Difference||6.9|-9.6|0.002
72355414|NCT01506271|144228495|NON_INFERIORITY|Unconditional asymptotic Miettinen and Nurminen method without stratification.|Percentage Difference|0.4|||<|0.001|TWO_SIDED|95.0|-7.2|8.2|||Miettinen and Nurminen||Relebactam minus Placebo|Relebactam 125 mg - Placebo: Percentage Difference||8.2|-7.2|< 0.001
72355415|NCT01506271|144228496|NON_INFERIORITY|Eight participants with indeterminate or missing response were excluded from the analysis.|Percentage Difference|0.0|||<|0.001|TWO_SIDED|95.0|-7.4|7.4|||Miettinen and Nurminen||Relebactam minus Placebo|Relebactam 250 mg - Placebo: Percentage Difference||7.4|-7.4|< 0.001
72355416|NCT01506271|144228496|NON_INFERIORITY|Eight participants with indeterminate or missing response were excluded from the analysis.|Percentage Difference|1.4|||<|0.001|TWO_SIDED|95.0|-5.2|8.6|||Miettinen and Nurminen||Relebactam minus Placebo|Relebactam 125 mg - Placebo: Percentage Difference||8.6|-5.2|< 0.001
72355417|NCT01506271|144228498|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|-1.0|||||TWO_SIDED|95.0|-7.3|5.1|||||Relebactam minus Placebo|Relebactam 250 mg - Placebo: Percentage Difference - Blood, lymphatic||5.1|-7.3|
72355418|NCT01506271|144228498|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|-4.4|||||TWO_SIDED|95.0|-10.3|0.1|||||Relebactam minus Placebo|Relebactam 125 mg - Placebo: Percentage Difference - Blood, lymphatic||0.1|-10.3|
72355419|NCT01506271|144228498|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|-1.0|||||TWO_SIDED|95.0|-5.2|5.0|||||Relebactam minus Placebo|Relebactam 250 mg - Placebo: Percentage Difference - Cardiac disorder||5.0|-5.2|
72355420|NCT01506271|144228498|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|0.8|||||TWO_SIDED|95.0|-4.5|6.3|||||Relebactam minus Placebo|Relebactam 125 mg - Placebo: Percentage Difference - Cardiac disorder||6.3|-4.5|
72355421|NCT01506271|144228498|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|5.6|||||TWO_SIDED|95.0|-3.9|15.3|||||Relebactam minus Placebo|Relebactam 250 mg - Placebo: Percentage Difference - GI disorders||15.3|-3.9|
72355422|NCT01506271|144228498|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|4.1|||||TWO_SIDED|95.0|-5.4|13.6|||||Relebactam minus Placebo|Relebactam 125 mg - Placebo: Percentage Difference - GI disorders||13.6|-5.4|
72355423|NCT01506271|144228498|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|4.2|||||TWO_SIDED|95.0|-2.0|11.0|||||Relebactam minus Placebo|Relebactam 250 mg - Placebo: Percentage Difference - Gen. dis \& admin.||11.0|-2.0|
72355424|NCT01506271|144228498|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|1.7|||||TWO_SIDED|95.0|-4.2|7.8|||||Relebactam minus Placebo|Relebactam 125 mg - Placebo: Percentage Difference - Gen. dis \& admin.||7.8|-4.2|
72355425|NCT01506271|144228498|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|4.1|||||TWO_SIDED|95.0|-3.6|12.0|||||Relebactam minus Placebo|Relebactam 250 mg - Placebo: Percentage Difference - Infect. \& Infest.||12.0|-3.6|
72355426|NCT01506271|144228498|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|0.7|||||TWO_SIDED|95.0|-6.5|8.0|||||Relebactam minus Placebo|Relebactam 125 mg - Placebo: Percentage Difference - Infect. \& Infest.||8.0|-6.5|
72355427|NCT01506271|144228498|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|-1.0|||||TWO_SIDED|95.0|-7.3|5.1|||||Relebactam minus Placebo|Relebactam 250 mg - Placebo: Percentage Difference - Injury, poison.||5.1|-7.3|
72355428|NCT01506271|144228498|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|1.6|||||TWO_SIDED|95.0|-5.0|8.5|||||Relebactam minus Placebo|Relebactam 1250mg - Placebo: Percentage Difference - Injury, poison.||8.5|-5.0|
72355429|NCT01506271|144228498|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|-1.2|||||TWO_SIDED|95.0|-9.8|7.4|||||Relebactam minus Placebo|Relebactam 250 mg - Placebo: Percentage Difference - Investigations||7.4|-9.8|
72355430|NCT01506271|144228498|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|-1.9|||||TWO_SIDED|95.0|-10.5|6.5|||||Relebactam minus Placebo|Relebactam 125 mg - Placebo: Percentage Difference - Investigations||6.5|-10.5|
72355431|NCT01506271|144228498|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|-2.7|||||TWO_SIDED|95.0|-8.4|2.2|||||Relebactam minus Placebo|Relebactam 250 mg - Placebo: Percentage Difference - Nervous System||2.2|-8.4|
72355432|NCT01506271|144228498|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|-2.7|||||TWO_SIDED|95.0|-8.4|2.2|||||Relebactam minus Placebo|Relebactam 125 mg - Placebo: Percentage Difference - Nervous System||2.2|-8.4|
72355433|NCT01506271|144228498|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|-0.1|||||TWO_SIDED|95.0|-5.7|5.4|||||Relebactam minus Placebo|Relebactam 250 mg - Placebo: Percentage Difference - Psychiatric disorders||5.4|-5.7|
72355434|NCT01506271|144228498|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|-0.1|||||TWO_SIDED|95.0|-5.7|5.5|||||Relebactam minus Placebo|Relebactam 125 mg - Placebo: Percentage Difference - Psychiatric disorders||5.5|-5.7|
72355435|NCT01506271|144228498|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|-1.8|||||TWO_SIDED|95.0|-7.2|3.0|||||Relebactam minus Placebo|Relebactam 250 mg - Placebo: Percentage Difference - Renal \& Urinary||3.0|-7.2|
72355436|NCT01506271|144228498|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|-1.8|||||TWO_SIDED|95.0|-7.2|3.0|||||Relebactam minus Placebo|Relebactam 125 mg - Placebo: Percentage Difference - Renal \& Urinary||3.0|-7.2|
72355437|NCT01506271|144228498|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|-4.4|||||TWO_SIDED|95.0|-10.7|0.7|||||Relebactam minus Placebo|Relebactam 250 mg - Placebo: Percentage Difference - Resp. \& chest||0.7|-10.7|
72355438|NCT01506271|144228498|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|-1.8|||||TWO_SIDED|95.0|-8.4|4.4|||||Relebactam minus Placebo|Relebactam 125 mg - Placebo: Percentage Difference - Resp. \& chest||4.4|-8.4|
72355439|NCT01506271|144228498|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|2.5|||||TWO_SIDED|95.0|-2.4|8.1|||||Relebactam minus Placebo|Relebactam 250 mg - Placebo: Percentage Difference - Skin \& subcutan.||8.1|-2.4|
72355440|NCT01506271|144228498|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|0.0|||||TWO_SIDED|95.0|-4.7|4.5|||||Relebactam minus Placebo|Relebactam 125 mg - Placebo: Percentage Difference - Skin \& subcutan.||4.5|-4.7|
72355441|NCT01506271|144228498|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|-3.6|||||TWO_SIDED|95.0|-9.9|2.0|||||Relebactam minus Placebo|Relebactam 250 mg - Placebo: Percentage Difference - Vascular disorders||2.0|-9.9|
72355442|NCT01506271|144228498|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|-0.1|||||TWO_SIDED|95.0|-6.9|6.6|||||Relebactam minus Placebo|Relebactam 125 mg - Placebo: Percentage Difference - Vascular disorders||6.6|-6.9|
72355443|NCT03040141|144228504|SUPERIORITY|The null hypothesis was defined as no treatment difference.|Odds Ratio (OR)|1.9||||0.181|TWO_SIDED|95.0|1.03|13.55|||Regression, Logistic|||All p-values are presented for informational purposes only; there were no adjustments for multiple comparisons.||13.55|1.03|0.181
72355444|NCT03040141|144228504|SUPERIORITY|The null hypothesis was defined as no treatment difference.|Odds Ratio (OR)|3.3||||0.073|TWO_SIDED|95.0|0.9|12.13|||Regression, Logistic|||All p-values are presented for informational purposes only; there were no adjustments for multiple comparisons.||12.13|0.90|0.073
72355445|NCT03040141|144228504|SUPERIORITY|The null hypothesis was defined as no treatment difference.|Odds Ratio (OR)|3.5||||0.037|TWO_SIDED|95.0|1.08|11.48|||Regression, Logistic|||All p-values are presented for informational purposes only; there were no adjustments for multiple comparisons.||11.48|1.08|0.037
72355446|NCT03040141|144228504|SUPERIORITY|The null hypothesis was defined as no treatment difference.|Odds Ratio (OR)|1.1||||0.814|TWO_SIDED|95.0|0.4|3.25|||Regression, Logistic|||All p-values are presented for informational purposes only; there were no adjustments for multiple comparisons.||3.25|0.40|0.814
72355447|NCT03040141|144228506|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.748||||||p-value is not adjusted for multiple comparisons, which were performed at the 0.05 significance level. The goal will be used to assess the strength of evidence to select the endpoints for a Phase 3 trial.|Chi-squared|All statistical comparisons were performed using 2-sided tests at the 0.05 significance level.||The VIS410 high-dose group was compared against the placebo group. The null hypothesis was defined as no treatment difference.||||0.748
72355448|NCT03040141|144228506|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.94||||||p-value is not adjusted for multiple comparisons, which were performed at the 0.05 significance level.|Chi-squared|All statistical comparisons were performed using 2-sided tests at the 0.05 significance level.||The VIS410 low-dose group was compared against the placebo group. The null hypothesis was defined as no treatment difference||||0.940
72355449|NCT03040141|144228506|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.902||||||p-value is not adjusted for multiple comparisons, which were performed at the 0.05 significance level.|Chi-squared|All statistical comparisons were performed using 2-sided tests at the 0.05 significance level.||The total VIS410 high-dose group (high-dose + low-dose) was compared against the placebo group. The null hypothesis was defined as no treatment difference.||||0.902
72355450|NCT03040141|144228506|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.283||||||p-value is not adjusted for multiple comparisons, which were performed at the 0.05 significance level.|Chi-squared|All statistical comparisons were performed using 2-sided tests at the 0.05 significance level.||The VIS410 high-dose group was compared against the VIS410 low-dose group. The null hypothesis was defined as no treatment difference.||||0.283
72355451|NCT03040141|144228507|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.919||||||p-value is not adjusted for multiple comparisons, which were performed at the 0.05 significance level.|Chi-squared|All statistical comparisons were performed using 2-sided tests at the 0.05 significance level.||The VIS410 high-dose group was compared against the placebo group. The null hypothesis was defined as no treatment difference.||||0.919
72355452|NCT03040141|144228507|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.9||||||p-value is not adjusted for multiple comparisons, which were performed at the 0.05 significance level.|Chi-squared|All statistical comparisons were performed using 2-sided tests at the 0.05 significance level.||The VIS410 low-dose group was compared against the placebo group. The null hypothesis was defined as no treatment difference.||||0.900
72355453|NCT03040141|144228507|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.99||||||p-value is not adjusted for multiple comparisons|Chi-squared|All statistical comparisons were performed using 2-sided tests at the 0.05 significance level||The combined VIS410 high- and low-dose groups was compared against the placebo group. The null hypothesis was defined as no treatment difference.||||0.990
72355454|NCT03040141|144228507|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.521||||||The p-value is not adjusted for multiple comparisons.|Chi-squared|All statistical comparisons were performed using 2-sided tests at the 0.05 significance level.||The VIS410 high-dose group was compared against the VIS410 low-dose group. The null hypothesis was defined as no treatment difference.||||0.521
72355455|NCT03040141|144228508|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.36||||||All p-values are presented for informational purposes only; there were no adjustments for multiple comparisons.|ANOVA|||The VIS410 high-dose group was compared against the placebo group. The null hypothesis was defined as no treatment difference.||||0.360
72355456|NCT03040141|144228509|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.735|||||||ANOVA|||||||0.735
72355457|NCT03040141|144228509|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.259|||||||ANOVA|||||||0.259
72355458|NCT03040141|144228509|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.644||||||The p-value is not adjusted for multiple comparisons. All statistical comparisons were performed using 2-sided tests at the 0.05 significance level.|ANOVA|||||||0.644
72355459|NCT03040141|144228509|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.146|||||||ANOVA|||||||0.146
72355460|NCT03040141|144228510|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.624||||||The p-value is not adjusted for multiple comparisons. All statistical comparisons were performed using 2-sided tests at the 0.05 significance level.|ANOVA|||||||0.624
72355461|NCT03040141|144228510|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.399||||||The p-value is not adjusted for multiple comparisons. All statistical comparisons were performed using 2-sided tests at the 0.05 significance level.|ANOVA|||||||0.399
72355462|NCT03040141|144228510|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.837|||||||ANOVA|||||||0.837
72355463|NCT03040141|144228510|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.183|||||||ANOVA|||||||0.183
72355464|NCT03040141|144228511|SUPERIORITY|The null hypothesis was defined as no treatment difference||||||0.88|||||||ANOVA|||||||0.880
72355465|NCT03040141|144228511|SUPERIORITY|The null hypothesis was defined as no treatment difference||||||0.778|||||||ANOVA|||||||0.778
72355466|NCT03040141|144228511|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.94|||||||ANOVA|||||||0.940
72355467|NCT03040141|144228511|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.662|||||||ANOVA|||||||0.662
72355468|NCT03040141|144228512|OTHER|||||||0.64|||||||Chi-squared|A Wald Chi-square statistic from a Cox proportional model was used for comparisons of treatment groups||||||0.640
72355469|NCT03040141|144228512|OTHER|||||||0.775|||||||Chi-squared|A Wald Chi-square statistic from a Cox proportional model was used for comparisons of treatment groups||||||0.775
72355470|NCT03040141|144228512|OTHER|||||||0.701|||||||Chi-squared|A Wald Chi-square statistic from a Cox proportional model was used for comparisons of treatment groups||||||0.701
72355471|NCT03040141|144228512|OTHER|||||||0.638|||||||Chi-squared|A Wald Chi-square statistic from a Cox proportional model was used for comparisons of treatment groups||||||0.638
72355472|NCT03040141|144228513|OTHER|||||||0.127|||||||Regression, Logistic|||||||0.127
72355473|NCT03040141|144228513|OTHER|||||||1|||||||Regression, Logistic|||||||1.000
72355474|NCT03040141|144228513|OTHER|||||||0.458|||||||Regression, Logistic|||||||0.458
72355475|NCT03040141|144228513|OTHER|||||||0.127|||||||Regression, Logistic|||||||0.127
72355476|NCT03040141|144228514|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.371|||||||ANOVA|||||||0.371
72355477|NCT03040141|144228514|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.735|||||||ANOVA|||||||0.735
72355478|NCT03040141|144228514|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.476|||||||ANOVA|||||||0.476
72355479|NCT03040141|144228514|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.581|||||||ANOVA|||||||0.581
72355480|NCT03040141|144228515|OTHER|||||||0.98|||||||Regression, Logistic|||||||0.980
72355481|NCT03040141|144228515|OTHER|||||||0.955|||||||Regression, Logistic|||||||0.955
72355482|NCT03040141|144228515|OTHER|||||||0.955|||||||Regression, Logistic|||||||0.955
72355483|NCT03040141|144228515|OTHER|||||||0.955|||||||Regression, Logistic|||||||0.955
72355484|NCT03040141|144228516|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.695|||||||ANOVA|||||||0.695
72355485|NCT03040141|144228516|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.542|||||||ANOVA|||||||0.542
72355486|NCT03040141|144228516|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.899|||||||ANOVA|||||||0.899
72355487|NCT03040141|144228516|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.321|||||||ANOVA|||||||0.321
72355488|NCT03040141|144228517|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.663|||||||ANOVA|||||||0.663
72355489|NCT03040141|144228517|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.54|||||||ANOVA|||||||0.540
72355490|NCT03040141|144228517|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.918|||||||ANOVA|||||||0.918
72355491|NCT03040141|144228517|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.294|||||||ANOVA|||||||0.294
72355492|NCT03040141|144228519|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.25|||||||Chi-squared|Wald Chi-square statistic from a Cox proportional model is used for comparisons of treatment groups.||All p-values are presented for informational purposes only; there were no adjustments for multiple comparisons.||||0.250
72355493|NCT03040141|144228519|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.133|||||||Chi-squared|Wald Chi-square statistic from a Cox proportional model is used for comparisons of treatment groups.||All p-values are presented for informational purposes only; there were no adjustments for multiple comparisons.||||0.133
72355494|NCT03040141|144228519|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.177|||||||Chi-squared|Wald Chi-square statistic from a Cox proportional model is used for comparisons of treatment groups.||||||0.177
72355495|NCT03040141|144228519|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.36|||||||Chi-squared|Wald Chi-square statistic from a Cox proportional model is used for comparisons of treatment groups.||All p-values are presented for informational purposes only; there were no adjustments for multiple comparisons||||0.360
72355496|NCT03040141|144228520|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.636|||||||Chi-squared|Wald Chi-square statistic from a Cox proportional model is used for comparisons of treatment groups.||All p-values are presented for informational purposes only; there were no adjustments for multiple comparisons.||||0.636
72355497|NCT03040141|144228520|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.446|||||||Chi-squared|Wald Chi-square statistic from a Cox proportional model is used for comparisons of treatment groups.||||||0.446
72355498|NCT03040141|144228520|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.53|||||||Chi-squared|Wald Chi-square statistic from a Cox proportional model is used for comparisons of treatment groups.||All p-values are presented for informational purposes only; there were no adjustments for multiple comparisons.||||0.530
72355499|NCT03040141|144228520|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.463|||||||Chi-squared|Wald Chi-square statistic from a Cox proportional model is used for comparisons of treatment groups||All p-values are presented for informational purposes only; there were no adjustments for multiple comparisons.||||0.463
72355500|NCT03040141|144228521|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.152|||||||Chi-squared|Wald Chi-square statistic from a Cox proportional model is used for comparisons of treatment groups.||All p-values are presented for informational purposes only; there were no adjustments for multiple comparisons.||||0.152
72355501|NCT03040141|144228521|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.176|||||||Chi-squared|Wald Chi-square statistic from a Cox proportional model is used for comparisons of treatment groups.||All p-values are presented for informational purposes only; there were no adjustments for multiple comparisons.||||0.176
72355502|NCT03040141|144228521|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.157|||||||Chi-squared|Wald Chi-square statistic from a Cox proportional model is used for comparisons of treatment groups.||All p-values are presented for informational purposes only; there were no adjustments for multiple comparisons.||||0.157
72355503|NCT03040141|144228521|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.844|||||||Chi-squared|Wald Chi-square statistic from a Cox proportional model is used for comparisons of treatment groups.||||||0.844
72355504|NCT03040141|144228522|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.531|||||||Chi-squared|Wald Chi-square statistic from a Cox proportional model is used for comparisons of treatment groups.||All p-values are presented for informational purposes only; there were no adjustments for multiple comparisons.||||0.531
72355505|NCT03040141|144228522|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.582|||||||Chi-squared|Wald Chi-square statistic from a Cox proportional model is used for comparisons of treatment groups.||All p-values are presented for informational purposes only; there were no adjustments for multiple comparisons.||||0.582
72355506|NCT03040141|144228522|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.55|||||||Chi-squared|Wald Chi-square statistic from a Cox proportional model is used for comparisons of treatment groups.||All p-values are presented for informational purposes only; there were no adjustments for multiple comparisons.||||0.550
72355507|NCT03040141|144228522|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.84|||||||Chi-squared|P-value determined based on Cox proportional hazards model Wald Chi-Square Statistic.||All p-values are presented for informational purposes only; there were no adjustments for multiple comparisons.||||0.840
72355508|NCT03040141|144228523|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.3534|||||||ANCOVA|||All p-values are presented for informational purposes only; there were no adjustments for multiple comparisons.||||0.3534
72355509|NCT03040141|144228523|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.7839|||||||ANCOVA|||All p-values are presented for informational purposes only; there were no adjustments for multiple comparisons.||||0.7839
72355510|NCT03040141|144228523|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.4893|||||||ANCOVA|||All p-values are presented for informational purposes only; there were no adjustments for multiple comparisons.||||0.4893
72355511|NCT03040141|144228523|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.5101|||||||ANCOVA|||All p-values are presented for informational purposes only; there were no adjustments for multiple comparisons.||||0.5101
72355512|NCT03040141|144228524|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.5436|||||||ANCOVA|||All p-values are presented for informational purposes only; there were no adjustments for multiple comparisons.||||0.5436
72355513|NCT03040141|144228524|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.8215|||||||ANCOVA|||All p-values are presented for informational purposes only; there were no adjustments for multiple comparisons.||||0.8215
72355514|NCT03040141|144228524|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.6319|||||||ANCOVA|||All p-values are presented for informational purposes only; there were no adjustments for multiple comparisons.||||0.6319
72355515|NCT03040141|144228524|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.7011|||||||ANCOVA|||All p-values are presented for informational purposes only; there were no adjustments for multiple comparisons.||||0.7011
72355516|NCT03040141|144228525|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.478|||||||Regression, Logistic|||All p-values are presented for informational purposes only; there were no adjustments for multiple comparisons.||||0.478
72355517|NCT03040141|144228525|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.468|||||||Regression, Logistic|||All p-values are presented for informational purposes only; there were no adjustments for multiple comparisons.||||0.468
72355518|NCT03040141|144228525|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.412|||||||Regression, Logistic|||All p-values are presented for informational purposes only; there were no adjustments for multiple comparisons||||0.412
72355519|NCT03040141|144228525|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.982|||||||Regression, Logistic|||All p-values are presented for informational purposes only; there were no adjustments for multiple comparisons||||0.982
72355520|NCT00462306|144228549|SUPERIORITY_OR_OTHER|||||||0.001||95.0||||4000 parturients and 500 non-pregnant achieves 90% power to detect a difference of 3% positive Berlin Questionnaire rates between pregnant and non-pregnant women using a two sided chi squared test at a significance level of 0.05|Chi-squared, Corrected|||We hypothesized that the rate of positive Berlin questionnaires would be higher in pregnant women compared to age matched controls undergoing surgery.||||0.001
72355521|NCT00462306|144228550|SUPERIORITY_OR_OTHER|||||||0.01||95.0|||||Chi-squared, Corrected|||||||0.01
72355522|NCT03515824|144228551|OTHER|Bayesian posterior credible interval|Pooled-adjacent-violator algorithm|0.0|||||TWO_SIDED|80.0|0.0|33.1||||||||33.1|0.0|
72355523|NCT03515824|144228551|OTHER|Bayesian posterior credible interval|Pooled-adjacent-violator algorithm|0.0|||||TWO_SIDED|80.0|0.0|33.1||||||||33.1|0.0|
72355524|NCT03515824|144228551|OTHER|Bayesian posterior credible interval|Pooled-adjacent-violator algorithm|15.4|||||TWO_SIDED|80.0|5.8|30.2||||||||30.2|5.8|
72355525|NCT03515824|144228554|OTHER|Clopper Pearson confidence interval method for binomial data|Objective Response Rate (ORR)|0.0|||||TWO_SIDED|95.0|0.0|70.8||||||||70.8|0.0|
72355526|NCT03515824|144228554|OTHER|Clopper Pearson confidence interval method for binomial data|Objective Response Rate (ORR)|0.0|||||TWO_SIDED|95.0|0.0|60.2||||||||60.2|0.0|
72355527|NCT03515824|144228554|OTHER|Clopper Pearson confidence interval method for binomial data|Objective Response Rate (ORR)|0.0|||||TWO_SIDED|95.0|0.0|21.8||||||||21.8|0.0|
72355528|NCT03515824|144228555|OTHER|Clopper Pearson confidence interval method for binomial data|Objective Response Rate (ORR)|0.0|||||TWO_SIDED|95.0|0.0|84.2||||||||84.2|0.0|
72355529|NCT03515824|144228555|OTHER|Clopper Pearson confidence interval method for binomial data|Objective Response Rate (ORR)|0.0|||||TWO_SIDED|95.0|0.0|70.8||||||||70.8|0.0|
72355530|NCT03515824|144228555|OTHER|Clopper Pearson confidence interval method for binomial data|Objective Response Rate )ORR)|0.0|||||TWO_SIDED|95.0|0.0|28.5||||||||28.5|0.0|
72355531|NCT00539994|144228593|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Fisher Exact|||||||<0.001
72355532|NCT00539994|144228593|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Fisher Exact|||||||<0.001
72355533|NCT03071263|144228602|SUPERIORITY||||||<|0.0001||||||α-level 0.05. Stratified by baseline potassium category (4.3-\<4.7 mEq/L or 4.7-5.1 mEq/L) and history of Type 1 or Type 2 diabetes mellitus (Yes or No) as randomized|Cochran-Mantel-Haenszel|||A sample size of 280 subjects has 90% power to detect a difference between treatment groups of 20% or more in the proportion of subjects remaining on spironolactone at Week 12, at α = 0.05.||||<0.0001
72355534|NCT03071263|144228603|SUPERIORITY|||||||0.5757||||||Baseline AOBP SBP as a covariate and treatment group, baseline serum potassium (K+ 4.3-\<4.7 or 4.7-5.1 mEq/L), and history of Type 1 or Type 2 diabetes mellitus (Yes or No) as factors in the model.|ANCOVA|||||||0.5757
72355535|NCT03071263|144228604|SUPERIORITY|||||||0.6367||||||Baseline AOBP SBP as a covariate and treatment group, baseline serum potassium (K+ 4.3-\<4.7 or 4.7-5.1 mEq/L), and history of Type 1 or Type 2 diabetes mellitus as factors in the model.|ANCOVA|||The p-value is from a test comparing the difference between two groups in the mean change in AOBP SBP from baseline.||||0.6367
72355536|NCT03084796|144228612|SUPERIORITY||Mean Difference (Final Values)|0.068||||0.037|TWO_SIDED|95.0|0.003|0.132|||Mixed Models Analysis|||"Comparison groups were:~Treatment A (CHF 5259 pMDI 12.5 μg TDD) versus Treatment E (Placebo).~Analyzed using linear mixed model repeated for measurements (MMRM), including treatment, visit, treatment by visit interaction, US regions (Midwest, Northeast, South and West), and smoking status at screening as fixed effects, and the baseline value, and baseline by visit interaction as covariates.~Adjusted for multiplicity based on the parametric simulation method by Edwards and Berry."||0.132|0.003|0.037
72355537|NCT03084796|144228612|SUPERIORITY||Mean Difference (Final Values)|0.116|||<|0.001|TWO_SIDED|95.0|0.051|0.181|||Mixed Models Analysis|||"Comparison treatment groups were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment E (Placebo).~Statistical analysis for was performed as described for the statistical analysis 1 for this outcome measure.~Adjusted for multiplicity based on the parametric simulation method by Edwards and Berry."||0.181|0.051|<0.001
72355538|NCT03084796|144228612|SUPERIORITY||Mean Difference (Final Values)|0.151|||<|0.001|TWO_SIDED|95.0|0.086|0.216|||Mixed Models Analysis|||"Comparison treatment groups were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment E (Placebo).~Statistical analysis for was performed as described for the statistical analysis 1 for this outcome measure.~Adjusted for multiplicity based on the parametric simulation method by Edwards and Berry."||0.216|0.086|<0.001
72355539|NCT03084796|144228612|SUPERIORITY||Mean Difference (Final Values)|0.145|||<|0.001|TWO_SIDED|95.0|0.081|0.209|||Mixed Models Analysis|||"Comparison treatment groups were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment E (Placebo).~Statistical analysis for was performed as described for the statistical analysis 1 for this outcome measure.~Adjusted for multiplicity based on the parametric simulation method by Edwards and Berry."||0.209|0.081|<0.001
72355540|NCT03084796|144228612|SUPERIORITY||Mean Difference (Final Values)|0.211|||<|0.001|TWO_SIDED|95.0|0.159|0.263|||Mixed Models Analysis|||"Comparison treatment groups were:~Treatment F (Tiotropium 18 μg TDD) versus Treatment E (Placebo).~Analyzed using a linear mixed model for repeated measures (MMRM) including treatment, visit, treatment by visit interaction, US regions (Midwest, Northeast, South and West) and smoking status at screening as fixed effects, and the baseline value and baseline by visit interaction as covariates."||0.263|0.159|<0.001
72355541|NCT03084796|144228612|SUPERIORITY||Mean Difference (Final Values)|0.048||||0.066|TWO_SIDED|95.0|-0.003|0.1|||Mixed Models Analysis|||"Comparison treatment groups were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Analyzed using a linear mixed model for repeated measures (MMRM) including treatment, visit, treatment by visit interaction, US regions (Midwest, Northeast, South and West) and smoking status at screening as fixed effects, and the baseline value and baseline by visit interaction as covariates."||0.100|-0.003|0.066
72355542|NCT03084796|144228612|SUPERIORITY||Mean Difference (Final Values)|0.083||||0.002|TWO_SIDED|95.0|0.031|0.135|||Mixed Models Analysis|||"Comparison treatment groups were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Analyzed using a linear mixed model for repeated measures (MMRM) including treatment, visit, treatment by visit interaction, US regions (Midwest, Northeast, South and West) and smoking status at screening as fixed effects, and the baseline value and baseline by visit interaction as covariates."||0.135|0.031|0.002
72355543|NCT03084796|144228612|SUPERIORITY||Mean Difference (Final Values)|0.077||||0.003|TWO_SIDED|95.0|0.026|0.128|||Mixed Models Analysis|||"Comparison treatment groups were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Analyzed using a linear mixed model for repeated measures (MMRM) including treatment, visit, treatment by visit interaction, US regions (Midwest, Northeast, South and West) and smoking status at screening as fixed effects, and the baseline value and baseline by visit interaction as covariates."||0.128|0.026|0.003
72355544|NCT03084796|144228612|SUPERIORITY||Mean Difference (Final Values)|0.035||||0.189|TWO_SIDED|95.0|-0.017|0.087|||Mixed Models Analysis|||"Comparison treatment groups were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD.~Analyzed using a linear mixed model for repeated measures (MMRM) including treatment, visit, treatment by visit interaction, US regions (Midwest, Northeast, South and West) and smoking status at screening as fixed effects, and the baseline value and baseline by visit interaction as covariates."||0.087|-0.017|0.189
72355545|NCT03084796|144228612|SUPERIORITY||Mean Difference (Final Values)|0.029||||0.273|TWO_SIDED|95.0|-0.023|0.08|||Mixed Models Analysis|||"Comparison treatment groups were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Analyzed using a linear mixed model for repeated measures (MMRM) including treatment, visit, treatment by visit interaction, US regions (Midwest, Northeast, South and West) and smoking status at screening as fixed effects, and the baseline value and baseline by visit interaction as covariates."||0.080|-0.023|0.273
72355546|NCT03084796|144228612|SUPERIORITY||Mean Difference (Final Values)|-0.006||||0.813|TWO_SIDED|95.0|-0.058|0.045|||Mixed Models Analysis|||"Comparison treatment groups were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment C (CHF 5259 pMDI 50 μg TDD).~Analyzed using a linear mixed model for repeated measures (MMRM) including treatment, visit, treatment by visit interaction, US regions (Midwest, Northeast, South and West) and smoking status at screening as fixed effects, and the baseline value and baseline by visit interaction as covariates."||0.045|-0.058|0.813
72429307|NCT01154036|144369652|SUPERIORITY_OR_OTHER_LEGACY||Difference in M-estimates|-12.7|||<|0.001|TWO_SIDED|95.0|-16.6|-8.7||The primary hypotheses were tested at 0.045, applying Hochberg's procedure.|Multiple Imputation Robust Regression|M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values||||-8.7|-16.6|<0.001
72355547|NCT03084796|144228613|SUPERIORITY||Mean Difference (Final Values)|0.059||||0.002|TWO_SIDED|95.0|0.022|0.095|||Mixed Models Analysis|||"Comparison treatment groups for this analysis were:~Treatment A (CHF 5259 pMDI 12.5 μg TDD) versus Treatment E (Placebo).~Analyzed using linear mixed model for repeated measurements (MMRM), including treatment, visit, treatment by visit interaction, US regions (Midwest, Northeast, South and West), and smoking status at screening as fixed effects, and the baseline value, and baseline by visit interaction as covariates."||0.095|0.022|0.002
72355548|NCT03084796|144228613|SUPERIORITY||Mean Difference (Final Values)|0.077|||<|0.001|TWO_SIDED|95.0|0.04|0.113|||Mixed Models Analysis|||"Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 for this outcome measure."||0.113|0.040|<0.001
72355549|NCT03084796|144228613|SUPERIORITY||Mean Difference (Final Values)|0.126|||<|0.001|TWO_SIDED|95.0|0.089|0.163|||Mixed Models Analysis|||"Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 for this outcome measure."||0.163|0.089|<0.001
72355550|NCT03084796|144228613|SUPERIORITY||Mean Difference (Final Values)|0.14|||<|0.001|TWO_SIDED|95.0|0.104|0.177|||Mixed Models Analysis|||"Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 for this outcome measure."||0.177|0.104|<0.001
72355551|NCT03084796|144228613|SUPERIORITY||Mean Difference (Final Values)|0.183|||<|0.001|TWO_SIDED|95.0|0.147|0.22|||Mixed Models Analysis|||"Comparison treatment groups for this analysis were:~Treatment F (Tiotropium 18 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 for this outcome measure."||0.220|0.147|<0.001
72355552|NCT03084796|144228613|SUPERIORITY||Mean Difference (Final Values)|0.018||||0.322|TWO_SIDED|95.0|-0.018|0.055|||Mixed Models Analysis|||"Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 for this outcome measure."||0.055|-0.018|0.322
72355553|NCT03084796|144228613|SUPERIORITY||Mean Difference (Final Values)|0.067|||<|0.001|TWO_SIDED|95.0|0.031|0.104|||Mixed Models Analysis|||"Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 for this outcome measure."||0.104|0.031|<0.001
72355554|NCT03084796|144228613|SUPERIORITY||Mean Difference (Final Values)|0.082|||<|0.001|TWO_SIDED|95.0|0.045|0.118|||Mixed Models Analysis|||"Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 for this outcome measure."||0.118|0.045|<0.001
72355555|NCT03084796|144228613|SUPERIORITY||Mean Difference (Final Values)|0.049||||0.008|TWO_SIDED|95.0|0.013|0.086|||Mixed Models Analysis|||"Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD.~Statistical analysis was performed as described for the statistical analysis 1 for this outcome measure."||0.086|0.013|0.008
72355556|NCT03084796|144228613|SUPERIORITY||Mean Difference (Final Values)|0.063|||<|0.001|TWO_SIDED|95.0|0.027|0.1|||Mixed Models Analysis|||"Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 for this outcome measure."||0.100|0.027|<0.001
72355557|NCT03084796|144228613|SUPERIORITY||Mean Difference (Final Values)|0.014||||0.443|TWO_SIDED|95.0|-0.022|0.051|||Mixed Models Analysis|||"Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment C (CHF 5259 pMDI 50 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 for this outcome measure."||0.051|-0.022|0.443
72355558|NCT03084796|144228614|SUPERIORITY||Mean Difference (Final Values)|0.072|||<|0.001|TWO_SIDED|95.0|0.038|0.105|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment A (CHF 5259 pMDI 12.5 μg TDD) versus Treatment E (Placebo).~Analyzed using linear mixed model for repeated measurements (MMRM), including treatment, visit, treatment by visit interaction, US regions (Midwest, Northeast, South and West), and smoking status at screening as fixed effects, and the baseline value, and baseline by visit interaction as covariates."||0.105|0.038|<0.001
72355559|NCT03084796|144228614|SUPERIORITY||Mean Difference (Final Values)|0.086|||<|0.001|TWO_SIDED|95.0|0.052|0.119|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.119|0.052|<0.001
72355560|NCT03084796|144228614|SUPERIORITY||Mean Difference (Final Values)|0.143|||<|0.001|TWO_SIDED|95.0|0.109|0.177|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.177|0.109|<0.001
72355561|NCT03084796|144228614|SUPERIORITY||Mean Difference (Final Values)|0.16|||<|0.001|TWO_SIDED|95.0|0.127|0.194|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.194|0.127|<0.001
72355562|NCT03084796|144228614|SUPERIORITY||Mean Difference (Final Values)|0.164|||<|0.001|TWO_SIDED|95.0|0.131|0.198|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment F (Tiotropium 18 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.198|0.131|<0.001
72355563|NCT03084796|144228614|SUPERIORITY||Mean Difference (Final Values)|0.014||||0.418|TWO_SIDED|95.0|-0.02|0.048|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.048|-0.020|0.418
72355564|NCT03084796|144228614|SUPERIORITY||Mean Difference (Final Values)|0.071|||<|0.001|TWO_SIDED|95.0|0.038|0.105|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.105|0.038|<0.001
72429308|NCT01154036|144369652|SUPERIORITY_OR_OTHER_LEGACY||Difference in M-estimate|-9.1|||<|0.001|TWO_SIDED|95.0|-12.9|-5.4||The primary hypotheses were tested at 0.045, applying Hochberg's procedure.|Multiple Imputation Robust Regression|M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values||||-5.4|-12.9|<0.001
72355565|NCT03084796|144228614|SUPERIORITY||Mean Difference (Final Values)|0.089|||<|0.001|TWO_SIDED|95.0|0.055|0.122|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.122|0.055|<0.001
72355566|NCT03084796|144228614|SUPERIORITY||Mean Difference (Final Values)|0.057|||<|0.001|TWO_SIDED|95.0|0.024|0.091|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.091|0.024|<0.001
72355567|NCT03084796|144228614|SUPERIORITY||Mean Difference (Final Values)|0.075|||<|0.001|TWO_SIDED|95.0|0.041|0.108|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.108|0.041|<0.001
72355568|NCT03084796|144228614|SUPERIORITY||Mean Difference (Final Values)|0.017||||0.308|TWO_SIDED|95.0|-0.016|0.051|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment C (CHF 5259 pMDI 50 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.051|-0.016|0.308
72355569|NCT03084796|144228614|SUPERIORITY||Mean Difference (Final Values)|0.092|||<|0.001|TWO_SIDED|95.0|0.038|0.147|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment A (CHF 5259 pMDI 12.5 μg TDD) versus Treatment E (Placebo).~Analyzed using linear mixed model repeated for measurements (MMRM), including treatment, visit, treatment by visit interaction, US regions (Midwest, Northeast, South and West), and smoking status at screening as fixed effects, and the baseline value, and baseline by visit interaction as covariates."||0.147|0.038|<0.001
72355570|NCT03084796|144228614|SUPERIORITY||Mean Difference (Final Values)|0.133|||<|0.001|TWO_SIDED|95.0|0.079|0.188|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment E (Placebo).~Analyzed, using linear mixed model repeated measurements (MMRM), including treatment, visit, treatment by visit interaction, US regions (Midwest, Northeast, South and West), and smoking status at screening as fixed effects, and the baseline value, and baseline by visit interaction as covariates."||0.188|0.079|<0.001
72355571|NCT03084796|144228614|SUPERIORITY||Mean Difference (Final Values)|0.174|||<|0.001|TWO_SIDED|95.0|0.12|0.229|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.229|0.120|<0.001
72355572|NCT03084796|144228614|SUPERIORITY||Mean Difference (Final Values)|0.181|||<|0.001|TWO_SIDED|95.0|0.127|0.235|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.235|0.127|<0.001
72355573|NCT03084796|144228614|SUPERIORITY||Mean Difference (Final Values)|0.229|||<|0.001|TWO_SIDED|95.0|0.175|0.284|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment F (Tiotropium 18 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.284|0.175|<0.001
72355574|NCT03084796|144228614|SUPERIORITY||Mean Difference (Final Values)|0.041||||0.141|TWO_SIDED|95.0|-0.013|0.095|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.095|-0.013|0.141
72355575|NCT03084796|144228614|SUPERIORITY||Mean Difference (Final Values)|0.082||||0.003|TWO_SIDED|95.0|0.028|0.137|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.137|0.028|0.003
72355576|NCT03084796|144228614|SUPERIORITY||Mean Difference (Final Values)|0.088||||0.001|TWO_SIDED|95.0|0.035|0.142|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.142|0.035|0.001
72355577|NCT03084796|144228614|SUPERIORITY||Mean Difference (Final Values)|0.041||||0.137|TWO_SIDED|95.0|-0.013|0.096|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.096|-0.013|0.137
72355578|NCT03084796|144228614|SUPERIORITY||Mean Difference (Final Values)|0.048||||0.082|TWO_SIDED|95.0|-0.006|0.101|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.101|-0.006|0.082
72355579|NCT03084796|144228614|SUPERIORITY||Mean Difference (Final Values)|0.006||||0.823|TWO_SIDED|95.0|-0.048|0.06|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment C (CHF 5259 pMDI 50 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.060|-0.048|0.823
72355580|NCT03084796|144228615|SUPERIORITY||Mean Difference (Final Values)|0.061||||0.002|TWO_SIDED|95.0|0.022|0.1|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment A (CHF 5259 pMDI 12.5 μg TDD) versus Treatment E (Placebo).~Analyzed using linear mixed model repeated for measurements (MMRM), including treatment, visit, treatment by visit interaction, US regions (Midwest, Northeast, South and West), and smoking status at screening as fixed effects, and the baseline value, and baseline by visit interaction as covariates."||0.100|0.022|0.002
72355581|NCT03084796|144228615|SUPERIORITY||Mean Difference (Final Values)|0.075|||<|0.001|TWO_SIDED|95.0|0.036|0.113|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.113|0.036|<0.001
72355582|NCT03084796|144228615|SUPERIORITY||Mean Difference (Final Values)|0.124|||<|0.001|TWO_SIDED|95.0|0.085|0.163|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.163|0.085|<0.001
72355583|NCT03084796|144228615|SUPERIORITY||Mean Difference (Final Values)|0.152|||<|0.001|TWO_SIDED|95.0|0.113|0.19|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.190|0.113|<0.001
72355584|NCT03084796|144228615|SUPERIORITY||Mean Difference (Final Values)|0.163|||<|0.001|TWO_SIDED|95.0|0.124|0.202|||MMRM|||"Day 1~Comparison treatment groups for this analysis were:~Treatment F (Tiotropium 18 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.202|0.124|<0.001
72355585|NCT03084796|144228615|SUPERIORITY||Mean Difference (Final Values)|0.014||||0.485|TWO_SIDED|95.0|-0.025|0.052|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.052|-0.025|0.485
72355586|NCT03084796|144228615|SUPERIORITY||Mean Difference (Final Values)|0.063||||0.001|TWO_SIDED|95.0|0.025|0.102|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.102|0.025|0.001
72355587|NCT03084796|144228615|SUPERIORITY||Mean Difference (Final Values)|0.091|||<|0.001|TWO_SIDED|95.0|0.053|0.13|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.130|0.053|<0.001
72355588|NCT03084796|144228615|SUPERIORITY||Mean Difference (Final Values)|0.05||||0.012|TWO_SIDED|95.0|0.011|0.088|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.088|0.011|0.012
72355589|NCT03084796|144228615|SUPERIORITY||Mean Difference (Final Values)|0.077|||<|0.001|TWO_SIDED|95.0|0.039|0.116|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.116|0.039|<0.001
72355590|NCT03084796|144228615|SUPERIORITY||Mean Difference (Final Values)|0.028||||0.157|TWO_SIDED|95.0|-0.011|0.066|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment C (CHF 5259 pMDI 50 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.066|-0.011|0.157
72355591|NCT03084796|144228615|SUPERIORITY||Mean Difference (Final Values)|0.069||||0.021|TWO_SIDED|95.0|0.011|0.128|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment A (CHF 5259 pMDI 12.5 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.128|0.011|0.021
72355592|NCT03084796|144228615|SUPERIORITY||Mean Difference (Final Values)|0.112|||<|0.001|TWO_SIDED|95.0|0.053|0.17|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.170|0.053|<0.001
72355593|NCT03084796|144228615|SUPERIORITY||Mean Difference (Final Values)|0.162|||<|0.001|TWO_SIDED|95.0|0.103|0.22|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.220|0.103|<0.001
72355594|NCT03084796|144228615|SUPERIORITY||Mean Difference (Final Values)|0.157|||<|0.001|TWO_SIDED|95.0|0.099|0.215|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.215|0.099|<0.001
72355595|NCT03084796|144228615|SUPERIORITY||Mean Difference (Final Values)|0.213|||<|0.001|TWO_SIDED|95.0|0.154|0.271|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment F (Tiotropium 18 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.271|0.154|<0.001
72355596|NCT03084796|144228615|SUPERIORITY||Mean Difference (Final Values)|0.043||||0.149|TWO_SIDED|95.0|-0.015|0.101|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.101|-0.015|0.149
72355597|NCT03084796|144228615|SUPERIORITY||Mean Difference (Final Values)|0.092||||0.002|TWO_SIDED|95.0|0.034|0.151|||Mixed Models Analysis|||"week 6~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.151|0.034|0.002
72355598|NCT03084796|144228615|SUPERIORITY||Mean Difference (Final Values)|0.088||||0.003|TWO_SIDED|95.0|0.031|0.146|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.146|0.031|0.003
72355599|NCT03084796|144228615|SUPERIORITY||Mean Difference (Final Values)|0.05||||0.096|TWO_SIDED|95.0|-0.009|0.108|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.108|-0.009|0.096
72355600|NCT03084796|144228615|SUPERIORITY||Mean Difference (Final Values)|0.045||||0.122|TWO_SIDED|95.0|-0.012|0.103|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.103|-0.012|0.122
72355601|NCT03084796|144228615|SUPERIORITY||Mean Difference (Final Values)|-0.004||||0.886|TWO_SIDED|95.0|-0.062|0.054|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment C (CHF 5259 pMDI 50 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.054|-0.062|0.886
72355602|NCT03084796|144228616|SUPERIORITY||Mean Difference (Final Values)|0.074||||0.029|TWO_SIDED|95.0|0.008|0.141|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment A (CHF 5259 pMDI 12.5 μg TDD) versus Treatment E (Placebo).~Analyzed using linear mixed model repeated for measurements (MMRM), including treatment, visit, treatment by visit interaction, US regions (Midwest, Northeast, South and West), and smoking status at screening as fixed effects, and the baseline value, and baseline by visit interaction as covariates."||0.141|0.008|0.029
72355603|NCT03084796|144228616|SUPERIORITY||Mean Difference (Final Values)|0.121|||<|0.001|TWO_SIDED|95.0|0.055|0.188|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.188|0.055|<0.001
72355604|NCT03084796|144228616|SUPERIORITY||Mean Difference (Final Values)|0.184|||<|0.001|TWO_SIDED|95.0|0.117|0.25|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.250|0.117|<0.001
72355605|NCT03084796|144228616|SUPERIORITY||Mean Difference (Final Values)|0.208|||<|0.001|TWO_SIDED|95.0|0.142|0.275|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.275|0.142|<0.001
72355606|NCT03084796|144228616|SUPERIORITY||Mean Difference (Final Values)|0.293|||<|0.001|TWO_SIDED|95.0|0.227|0.36|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment F (Tiotropium 18 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.360|0.227|<0.001
72355607|NCT03084796|144228616|SUPERIORITY||Mean Difference (Final Values)|0.047||||0.161|TWO_SIDED|95.0|-0.019|0.113|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.113|-0.019|0.161
72355608|NCT03084796|144228616|SUPERIORITY||Mean Difference (Final Values)|0.109||||0.001|TWO_SIDED|95.0|0.043|0.176|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.176|0.043|0.001
72355609|NCT03084796|144228616|SUPERIORITY||Mean Difference (Final Values)|0.134|||<|0.001|TWO_SIDED|95.0|0.068|0.201|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.201|0.068|<0.001
72355610|NCT03084796|144228616|SUPERIORITY||Mean Difference (Final Values)|0.062||||0.066|TWO_SIDED|95.0|-0.004|0.128|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.128|-0.004|0.066
72355611|NCT03084796|144228616|SUPERIORITY||Mean Difference (Final Values)|0.087||||0.01|TWO_SIDED|95.0|0.021|0.153|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.153|0.021|0.010
72355612|NCT03084796|144228616|SUPERIORITY||Mean Difference (Final Values)|0.025||||0.465|TWO_SIDED|95.0|-0.042|0.091|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment C (CHF 5259 pMDI 50 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.091|-0.042|0.465
72355613|NCT03084796|144228616|SUPERIORITY||Mean Difference (Final Values)|0.112||||0.008|TWO_SIDED|95.0|0.03|0.195|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment A (CHF 5259 pMDI 12.5 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.195|0.030|0.008
72355614|NCT03084796|144228616|SUPERIORITY||Mean Difference (Final Values)|0.173|||<|0.001|TWO_SIDED|95.0|0.091|0.256|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.256|0.091|<0.001
72355615|NCT03084796|144228616|SUPERIORITY||Mean Difference (Final Values)|0.219|||<|0.001|TWO_SIDED|95.0|0.136|0.302|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.302|0.136|<0.001
72355616|NCT03084796|144228616|SUPERIORITY||Mean Difference (Final Values)|0.213|||<|0.001|TWO_SIDED|95.0|0.131|0.295|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.295|0.131|<0.001
72355617|NCT03084796|144228616|SUPERIORITY||Mean Difference (Final Values)|0.326|||<|0.001|TWO_SIDED|95.0|0.244|0.409|||McNemar|||"Week 6~Comparison treatment groups for this analysis were:~Treatment F (Tiotropium 18 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.409|0.244|<0.001
72355618|NCT03084796|144228616|SUPERIORITY||Mean Difference (Final Values)|0.061||||0.144|TWO_SIDED|95.0|-0.021|0.143|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.143|-0.021|0.144
72355619|NCT03084796|144228616|SUPERIORITY||Mean Difference (Final Values)|0.107||||0.011|TWO_SIDED|95.0|0.024|0.189|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.189|0.024|0.011
72355620|NCT03084796|144228616|SUPERIORITY||Mean Difference (Final Values)|0.101||||0.016|TWO_SIDED|95.0|0.019|0.182|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.182|0.019|0.016
72355621|NCT03084796|144228616|SUPERIORITY||Mean Difference (Final Values)|0.045||||0.28|TWO_SIDED|95.0|-0.037|0.128|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.128|-0.037|0.280
72355622|NCT03084796|144228616|SUPERIORITY||Mean Difference (Final Values)|0.039||||0.342|TWO_SIDED|95.0|-0.042|0.121|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.121|-0.042|0.342
72355623|NCT03084796|144228616|SUPERIORITY||Mean Difference (Final Values)|-0.006||||0.886|TWO_SIDED|95.0|-0.088|0.076|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment C (CHF 5259 pMDI 50 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.076|-0.088|0.886
72355624|NCT03084796|144228617|SUPERIORITY||Mean Difference (Final Values)|0.097||||0.003|TWO_SIDED|95.0|0.032|0.163|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment A (CHF 5259 pMDI 12.5 μg TDD) versus Treatment E (Placebo).~Analyzed using linear mixed model repeated for measurements (MMRM), including treatment, visit, treatment by visit interaction, US regions (Midwest, Northeast, South and West), and smoking status at screening as fixed effects, and the baseline value, and baseline by visit interaction as covariates."||0.163|0.032|0.003
72355625|NCT03084796|144228617|SUPERIORITY||Mean Difference (Final Values)|0.156|||<|0.001|TWO_SIDED|95.0|0.091|0.221|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.221|0.091|<0.001
72355626|NCT03084796|144228617|SUPERIORITY||Mean Difference (Final Values)|0.208|||<|0.001|TWO_SIDED|95.0|0.143|0.273|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.273|0.143|<0.001
72355627|NCT03084796|144228617|SUPERIORITY||Mean Difference (Final Values)|0.237|||<|0.001|TWO_SIDED|95.0|0.172|0.302|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.302|0.172|<0.001
72355628|NCT03084796|144228617|SUPERIORITY||Mean Difference (Final Values)|0.276|||<|0.001|TWO_SIDED|95.0|0.211|0.341|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment F (Tiotropium 18 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.341|0.211|<0.001
72355629|NCT03084796|144228617|SUPERIORITY||Mean Difference (Final Values)|0.059||||0.076|TWO_SIDED|95.0|-0.006|0.124|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.124|-0.006|0.076
72355630|NCT03084796|144228617|SUPERIORITY||Mean Difference (Final Values)|0.111|||<|0.001|TWO_SIDED|95.0|0.046|0.176|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.176|0.046|<0.001
72355631|NCT03084796|144228617|SUPERIORITY||Mean Difference (Final Values)|0.14|||<|0.001|TWO_SIDED|95.0|0.075|0.205|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.205|0.075|<0.001
72355632|NCT03084796|144228617|SUPERIORITY||Mean Difference (Final Values)|0.052||||0.116|TWO_SIDED|95.0|-0.013|0.117|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.117|-0.013|0.116
72355633|NCT03084796|144228617|SUPERIORITY||Mean Difference (Final Values)|0.081||||0.014|TWO_SIDED|95.0|0.016|0.146|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.146|0.016|0.014
72355634|NCT03084796|144228617|SUPERIORITY||Mean Difference (Final Values)|0.029||||0.384|TWO_SIDED|95.0|-0.036|0.094|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment C (CHF 5259 pMDI 50 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.094|-0.036|0.384
72355635|NCT03084796|144228617|SUPERIORITY||Mean Difference (Final Values)|0.15|||<|0.001|TWO_SIDED|95.0|0.064|0.236|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment A (CHF 5259 pMDI 12.5 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.236|0.064|<0.001
72355636|NCT03084796|144228617|SUPERIORITY||Mean Difference (Final Values)|0.204|||<|0.001|TWO_SIDED|95.0|0.118|0.29|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.290|0.118|<0.001
72355637|NCT03084796|144228617|SUPERIORITY||Mean Difference (Final Values)|0.248|||<|0.001|TWO_SIDED|95.0|0.162|0.335|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.335|0.162|<0.001
72355638|NCT03084796|144228617|SUPERIORITY||Mean Difference (Final Values)|0.254|||<|0.001|TWO_SIDED|95.0|0.168|0.339|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.339|0.168|<0.001
72355639|NCT03084796|144228617|SUPERIORITY||Mean Difference (Final Values)|0.354|||<|0.001|TWO_SIDED|95.0|0.268|0.439|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment F (Tiotropium 18 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.439|0.268|<0.001
72355640|NCT03084796|144228617|SUPERIORITY||Mean Difference (Final Values)|0.054||||0.214|TWO_SIDED|95.0|-0.031|0.14|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.140|-0.031|0.214
72355641|NCT03084796|144228617|SUPERIORITY||Mean Difference (Final Values)|0.098||||0.025|TWO_SIDED|95.0|0.012|0.184|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.184|0.012|0.025
72355642|NCT03084796|144228617|SUPERIORITY||Mean Difference (Final Values)|0.104||||0.016|TWO_SIDED|95.0|0.019|0.189|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.189|0.019|0.016
72355643|NCT03084796|144228617|SUPERIORITY||Mean Difference (Final Values)|0.044||||0.313|TWO_SIDED|95.0|-0.042|0.13|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.130|-0.042|0.313
72355644|NCT03084796|144228617|SUPERIORITY||Mean Difference (Final Values)|0.05||||0.25|TWO_SIDED|95.0|-0.035|0.135|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure.~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.135|-0.035|0.250
72355645|NCT03084796|144228617|SUPERIORITY||Mean Difference (Final Values)|0.006||||0.898|TWO_SIDED|95.0|-0.08|0.091|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment C (CHF 5259 pMDI 50 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.091|-0.080|0.898
72355646|NCT03084796|144228618|SUPERIORITY||Mean Difference (Final Values)|0.079||||0.035|TWO_SIDED|95.0|0.006|0.153|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment A (CHF 5259 pMDI 12.5 μg TDD) versus Treatment E (Placebo).~Analyzed, using linear mixed model for repeated measurements (MMRM), including treatment, visit, treatment by visit interaction, US regions (Midwest, Northeast, South and West), and smoking status at screening as fixed effects, and the baseline value, and baseline by visit interaction as covariates."||0.153|0.006|0.035
72355647|NCT03084796|144228618|SUPERIORITY||Mean Difference (Final Values)|0.158|||<|0.001|TWO_SIDED|95.0|0.085|0.232|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.232|0.085|<0.001
72355648|NCT03084796|144228618|SUPERIORITY||Mean Difference (Final Values)|0.201|||<|0.001|TWO_SIDED|95.0|0.127|0.275|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.275|0.127|<0.001
72355649|NCT03084796|144228618|SUPERIORITY||Mean Difference (Final Values)|0.241|||<|0.001|TWO_SIDED|95.0|0.168|0.315|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.315|0.168|<0.001
72355650|NCT03084796|144228618|SUPERIORITY||Mean Difference (Final Values)|0.277|||<|0.001|TWO_SIDED|95.0|0.204|0.351|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment F (Tiotropium 18 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.351|0.204|<0.001
72355651|NCT03084796|144228618|SUPERIORITY||Mean Difference (Final Values)|0.079||||0.035|TWO_SIDED|95.0|0.005|0.152|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.152|0.005|0.035
72355652|NCT03084796|144228618|SUPERIORITY||Mean Difference (Final Values)|0.121||||0.001|TWO_SIDED|95.0|0.048|0.195|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.195|0.048|0.001
72355653|NCT03084796|144228618|SUPERIORITY||Mean Difference (Final Values)|0.162|||<|0.001|TWO_SIDED|95.0|0.088|0.235|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.235|0.088|<0.001
72355654|NCT03084796|144228618|SUPERIORITY||Mean Difference (Final Values)|0.043||||0.256|TWO_SIDED|95.0|-0.031|0.116|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.116|-0.031|0.256
72355655|NCT03084796|144228618|SUPERIORITY||Mean Difference (Final Values)|0.083||||0.027|TWO_SIDED|95.0|0.01|0.156|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.156|0.010|0.027
72355656|NCT03084796|144228618|SUPERIORITY||Mean Difference (Final Values)|0.04||||0.281|TWO_SIDED|95.0|-0.033|0.114|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment C (CHF 5259 pMDI 50 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.114|-0.033|0.281
72355657|NCT03084796|144228618|SUPERIORITY||Mean Difference (Final Values)|0.141||||0.003|TWO_SIDED|95.0|0.05|0.232|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment A (CHF 5259 pMDI 12.5 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.232|0.050|0.003
72355658|NCT03084796|144228618|SUPERIORITY||Mean Difference (Final Values)|0.197|||<|0.001|TWO_SIDED|95.0|0.106|0.288|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.288|0.106|<0.001
72355659|NCT03084796|144228618|SUPERIORITY||Mean Difference (Final Values)|0.249|||<|0.001|TWO_SIDED|95.0|0.157|0.34|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.340|0.157|<0.001
72355660|NCT03084796|144228618|SUPERIORITY||Mean Difference (Final Values)|0.245|||<|0.001|TWO_SIDED|95.0|0.155|0.336|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.336|0.155|<0.001
72355661|NCT03084796|144228618|SUPERIORITY||Mean Difference (Final Values)|0.348|||<|0.001|TWO_SIDED|95.0|0.258|0.439|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment F (Tiotropium 18 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.439|0.258|<0.001
72355662|NCT03084796|144228618|SUPERIORITY||Mean Difference (Final Values)|0.056||||0.222|TWO_SIDED|95.0|-0.034|0.147|||Mixed Models Analysis|||"week 6~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.147|-0.034|0.222
72355663|NCT03084796|144228618|SUPERIORITY||Hazard Ratio, log|0.108||||0.02|TWO_SIDED|95.0|0.017|0.199|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.199|0.017|0.020
72355664|NCT03084796|144228618|SUPERIORITY||Mean Difference (Final Values)|0.105||||0.022|TWO_SIDED|95.0|0.015|0.195|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.195|0.015|0.022
72355665|NCT03084796|144228618|SUPERIORITY||Mean Difference (Final Values)|0.052||||0.262|TWO_SIDED|95.0|-0.039|0.143|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.143|-0.039|0.262
72355666|NCT03084796|144228618|SUPERIORITY||Mean Difference (Final Values)|0.048||||0.29|TWO_SIDED|95.0|-0.041|0.138|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.138|-0.041|0.290
72355667|NCT03084796|144228618|SUPERIORITY||Mean Difference (Final Values)|-0.004||||0.938|TWO_SIDED|95.0|-0.094|0.087|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment C (CHF 5259 pMDI 50 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.087|-0.094|0.938
72355668|NCT03084796|144228619|SUPERIORITY||Hazard Ratio (HR)|1.64||||0.002|TWO_SIDED|95.0|1.21|2.24|||Regression, Cox|||"Comparison treatment groups for this analysis were:~Treatment A (CHF 5259 pMDI 12.5 μg TDD) versus Treatment E (Placebo).~Analyzed using Cox proportional hazards model, including treatment, US regions (Midwest, Northeast, South and West), and smoking status at screening as fixed effects, and baseline FEV1 value as covariate."||2.24|1.21|0.002
72355669|NCT03084796|144228619|SUPERIORITY||Hazard Ratio (HR)|2.18|||<|0.001|TWO_SIDED|95.0|1.61|2.94|||Regression, Cox|||"Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||2.94|1.61|<0.001
72355670|NCT03084796|144228619|SUPERIORITY||Hazard Ratio (HR)|2.79|||<|0.001|TWO_SIDED|95.0|2.07|3.78|||Regression, Cox|||"Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||3.78|2.07|<0.001
72355671|NCT03084796|144228619|SUPERIORITY||Hazard Ratio (HR)|3.07|||<|0.001|TWO_SIDED|95.0|2.27|4.15|||Regression, Cox|||"Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||4.15|2.27|<0.001
72355672|NCT03084796|144228619|SUPERIORITY||Hazard Ratio (HR)|3.1|||<|0.001|TWO_SIDED|95.0|2.3|4.17|||Regression, Cox|||"Comparison treatment groups for this analysis were:~Treatment F (Tiotropium 18 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||4.17|2.30|<0.001
72355673|NCT03084796|144228619|SUPERIORITY||Hazard Ratio (HR)|1.32||||0.052|TWO_SIDED|95.0|1.0|1.76|||Regression, Cox|||"Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||1.76|1.00|0.052
72355674|NCT03084796|144228619|SUPERIORITY||Hazard Ratio (HR)|1.7|||<|0.001|TWO_SIDED|95.0|1.28|2.26|||Regression, Cox|||"Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||2.26|1.28|<0.001
72355675|NCT03084796|144228619|SUPERIORITY||Hazard Ratio (HR)|1.87|||<|0.001|TWO_SIDED|95.0|1.41|2.48|||Regression, Cox|||"Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||2.48|1.41|<0.001
72355676|NCT03084796|144228619|SUPERIORITY||Hazard Ratio (HR)|1.28||||0.074|TWO_SIDED|95.0|0.98|1.69|||Regression, Cox|||"Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||1.69|0.98|0.074
72355677|NCT03084796|144228619|SUPERIORITY||Hazard Ratio (HR)|1.41||||0.013|TWO_SIDED|95.0|1.08|1.85|||Regression, Cox|||"Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||1.85|1.08|0.013
72355678|NCT03084796|144228619|SUPERIORITY||Hazard Ratio (HR)|1.1||||0.494|TWO_SIDED|95.0|0.84|1.44|||Regression, Cox|||"Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment C (CHF 5259 pMDI 50 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||1.44|0.84|0.494
72355679|NCT03084796|144228621|SUPERIORITY||Mean Difference (Final Values)|0.059||||0.017|TWO_SIDED|95.0|0.011|0.107|||Mixed Models Analysis|||"Week 3~Comparison treatment groups for this analysis were:~Treatment A (CHF 5259 pMDI 12.5 μg TDD) versus Treatment E (Placebo).~Analyzed using linear mixed model repeated for measurements (MMRM), including treatment, visit, treatment by visit interaction, US regions (Midwest, Northeast, South and West), and smoking status at screening as fixed effects, and the baseline value, and baseline by visit interaction as covariates."||0.107|0.011|0.017
72355680|NCT03084796|144228621|SUPERIORITY||Mean Difference (Final Values)|0.08||||0.001|TWO_SIDED|95.0|0.032|0.128|||Mixed Models Analysis|||"Week 3~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.128|0.032|0.001
72355681|NCT03084796|144228621|SUPERIORITY||Mean Difference (Final Values)|0.122|||<|0.001|TWO_SIDED|95.0|0.074|0.17|||Mixed Models Analysis|||"Week 3~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.170|0.074|<0.001
72355682|NCT03084796|144228621|SUPERIORITY||Hazard Ratio, log|0.111|||<|0.001|TWO_SIDED|95.0|0.063|0.159|||Mixed Models Analysis|||"Week 3~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.159|0.063|<0.001
72355683|NCT03084796|144228621|SUPERIORITY||Mean Difference (Final Values)|0.122|||<|0.001|TWO_SIDED|95.0|0.074|0.17|||Mixed Models Analysis|||"Week 3~Comparison treatment groups for this analysis were:~Treatment F (Tiotropium 18 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.170|0.074|<0.001
72355684|NCT03084796|144228621|SUPERIORITY||Mean Difference (Final Values)|0.021||||0.377|TWO_SIDED|95.0|-0.026|0.069|||Mixed Models Analysis|||"Week 3~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.069|-0.026|0.377
72355685|NCT03084796|144228621|SUPERIORITY||Mean Difference (Final Values)|0.063||||0.01|TWO_SIDED|95.0|0.015|0.111|||Mixed Models Analysis|||"Week 3~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.111|0.015|0.010
72355686|NCT03084796|144228621|SUPERIORITY||Mean Difference (Final Values)|0.052||||0.031|TWO_SIDED|95.0|0.005|0.1|||Mixed Models Analysis|||"Week 3~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.100|0.005|0.031
72355687|NCT03084796|144228621|SUPERIORITY||Mean Difference (Final Values)|0.042||||0.085|TWO_SIDED|95.0|-0.006|0.089|||Mixed Models Analysis|||"Week 3~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.089|-0.006|0.085
72355688|NCT03084796|144228621|SUPERIORITY||Mean Difference (Final Values)|0.031||||0.199|TWO_SIDED|95.0|-0.016|0.079|||Mixed Models Analysis|||"Week 3~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.079|-0.016|0.199
72355689|NCT03084796|144228621|SUPERIORITY||Mean Difference (Final Values)|-0.011||||0.657|TWO_SIDED|95.0|-0.058|0.037|||Mixed Models Analysis|||"Week 3~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment C (CHF 5259 pMDI 50 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.037|-0.058|0.657
72355690|NCT03084796|144228621|SUPERIORITY||Mean Difference (Final Values)|0.032||||0.246|TWO_SIDED|95.0|-0.022|0.086|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment A (CHF 5259 pMDI 12.5 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.086|-0.022|0.246
72355691|NCT03084796|144228621|SUPERIORITY||Mean Difference (Final Values)|0.1|||<|0.001|TWO_SIDED|95.0|0.046|0.154|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.154|0.046|<0.001
72355692|NCT03084796|144228621|SUPERIORITY||Mean Difference (Final Values)|0.119|||<|0.001|TWO_SIDED|95.0|0.064|0.173|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.173|0.064|<0.001
72355693|NCT03084796|144228621|SUPERIORITY||Mean Difference (Final Values)|0.142|||<|0.001|TWO_SIDED|95.0|0.088|0.196|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.196|0.088|<0.001
72355694|NCT03084796|144228621|SUPERIORITY||Mean Difference (Final Values)|0.124|||<|0.001|TWO_SIDED|95.0|0.07|0.178|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment F (Tiotropium 18 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.178|0.070|<0.001
72355695|NCT03084796|144228621|SUPERIORITY||Mean Difference (Final Values)|0.068||||0.014|TWO_SIDED|95.0|0.014|0.121|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.121|0.014|0.014
72355696|NCT03084796|144228621|SUPERIORITY||Mean Difference (Final Values)|0.087||||0.002|TWO_SIDED|95.0|0.032|0.141|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.141|0.032|0.002
72355697|NCT03084796|144228621|SUPERIORITY||Mean Difference (Final Values)|0.11|||<|0.001|TWO_SIDED|95.0|0.057|0.163|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.163|0.057|<0.001
72355698|NCT03084796|144228621|SUPERIORITY||Mean Difference (Final Values)|0.019||||0.493|TWO_SIDED|95.0|-0.035|0.073|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.073|-0.035|0.493
72355699|NCT03084796|144228621|SUPERIORITY||Mean Difference (Final Values)|0.042||||0.119|TWO_SIDED|95.0|-0.011|0.096|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.096|-0.011|0.119
72355700|NCT03084796|144228621|SUPERIORITY||Mean Difference (Final Values)|0.023||||0.392|TWO_SIDED|95.0|-0.03|0.077|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment C (CHF 5259 pMDI 50 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.077|-0.030|0.392
72355701|NCT03084796|144228622|SUPERIORITY||Mean Difference (Final Values)|0.109||||0.023|TWO_SIDED|95.0|0.015|0.203|||Mixed Models Analysis|||"Week 3~Comparison treatment groups for this analysis were:~Treatment A (CHF 5259 pMDI 12.5 μg TDD) versus Treatment E (Placebo).~Analyzed using linear mixed model for repeated measurements (MMRM), including treatment, visit, treatment by visit interaction, US regions (Midwest, Northeast, South and West), and smoking status at screening as fixed effects, and the baseline value, and baseline by visit interaction as covariates."||0.203|0.015|0.023
72355702|NCT03084796|144228622|SUPERIORITY||Mean Difference (Final Values)|0.09||||0.058|TWO_SIDED|95.0|-0.003|0.184|||Mixed Models Analysis|||"Week 3~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.184|-0.003|0.058
72355703|NCT03084796|144228622|SUPERIORITY||Mean Difference (Final Values)|0.059||||0.215|TWO_SIDED|95.0|-0.035|0.153|||Mixed Models Analysis|||"Week 3~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.153|-0.035|0.215
72355704|NCT03084796|144228622|SUPERIORITY||Mean Difference (Final Values)|0.093||||0.051|TWO_SIDED|95.0|-0.001|0.187|||Mixed Models Analysis|||"Week 3~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.187|-0.001|0.051
72355705|NCT03084796|144228622|SUPERIORITY||Mean Difference (Final Values)|0.044||||0.364|TWO_SIDED|95.0|-0.051|0.138|||Mixed Models Analysis|||"Week 3~Comparison treatment groups for this analysis were:~Treatment F (Tiotropium 18 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.138|-0.051|0.364
72355706|NCT03084796|144228622|SUPERIORITY||Mean Difference (Final Values)|-0.019||||0.694|TWO_SIDED|95.0|-0.112|0.074|||Mixed Models Analysis|||"Week 3~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.074|-0.112|0.694
72355707|NCT03084796|144228622|SUPERIORITY||Mean Difference (Final Values)|-0.05||||0.297|TWO_SIDED|95.0|-0.143|0.044|||Mixed Models Analysis|||"Week 3~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.044|-0.143|0.297
72355708|NCT03084796|144228622|SUPERIORITY||Mean Difference (Final Values)|-0.016||||0.734|TWO_SIDED|95.0|-0.109|0.077|||Mixed Models Analysis|||"Week 3~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.077|-0.109|0.734
72355709|NCT03084796|144228622|SUPERIORITY||Mean Difference (Final Values)|-0.031||||0.514|TWO_SIDED|95.0|-0.124|0.062|||Mixed Models Analysis|||"Week 3~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.062|-0.124|0.514
72355710|NCT03084796|144228622|SUPERIORITY||Mean Difference (Final Values)|0.003||||0.957|TWO_SIDED|95.0|-0.09|0.095|||Mixed Models Analysis|||"Week 3~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.095|-0.090|0.957
72355711|NCT03084796|144228622|SUPERIORITY||Mean Difference (Final Values)|0.034||||0.479|TWO_SIDED|95.0|-0.06|0.127|||Mixed Models Analysis|||"Week 3~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment C (CHF 5259 pMDI 50 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.127|-0.060|0.479
72355712|NCT03084796|144228622|SUPERIORITY||Mean Difference (Final Values)|0.02||||0.687|TWO_SIDED|95.0|-0.079|0.12|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment A (CHF 5259 pMDI 12.5 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.120|-0.079|0.687
72355713|NCT03084796|144228622|SUPERIORITY||Mean Difference (Final Values)|0.066||||0.195|TWO_SIDED|95.0|-0.034|0.165|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.165|-0.034|0.195
72355714|NCT03084796|144228622|SUPERIORITY||Mean Difference (Final Values)|0.111||||0.03|TWO_SIDED|95.0|0.011|0.212|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.212|0.011|0.030
72355715|NCT03084796|144228622|SUPERIORITY||Mean Difference (Final Values)|0.08||||0.112|TWO_SIDED|95.0|-0.019|0.179|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.179|-0.019|0.112
72355716|NCT03084796|144228622|SUPERIORITY||Mean Difference (Final Values)|0.074||||0.147|TWO_SIDED|95.0|-0.026|0.174|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment F (Tiotropium 18 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.174|-0.026|0.147
72355717|NCT03084796|144228622|SUPERIORITY||Mean Difference (Final Values)|0.045||||0.37|TWO_SIDED|95.0|-0.054|0.144|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.144|-0.054|0.370
72355718|NCT03084796|144228622|SUPERIORITY||Mean Difference (Final Values)|0.091||||0.074|TWO_SIDED|95.0|-0.009|0.19|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.190|-0.009|0.074
72355719|NCT03084796|144228622|SUPERIORITY||Mean Difference (Final Values)|0.06||||0.233|TWO_SIDED|95.0|-0.039|0.158|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.158|-0.039|0.233
72355720|NCT03084796|144228622|SUPERIORITY||Mean Difference (Final Values)|0.046||||0.369|TWO_SIDED|95.0|-0.054|0.145|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.145|-0.054|0.369
72355721|NCT03084796|144228622|SUPERIORITY||Mean Difference (Final Values)|0.014||||0.773|TWO_SIDED|95.0|-0.084|0.112|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.112|-0.084|0.773
72355722|NCT03084796|144228622|SUPERIORITY||Mean Difference (Final Values)|-0.031||||0.536|TWO_SIDED|95.0|-0.13|0.068|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment C (CHF 5259 pMDI 50 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.068|-0.130|0.536
72355723|NCT03084796|144228623|SUPERIORITY||Odds Ratio (OR)|1.05||||0.848|TWO_SIDED|95.0|0.62|1.77|||Regression, Logistic|||"Week 3~Comparison treatment groups for this analysis were:~Treatment A (CHF 5259 pMDI 12.5 μg TDD) versus Treatment E (Placebo).~Analysis based on logistic regression model - multiple logistic regression model, with treatment, US regions, smoking status at screening, and BDI as covariates."||1.77|0.62|0.848
72355724|NCT03084796|144228623|SUPERIORITY||Odds Ratio (OR)|1.35||||0.264|TWO_SIDED|95.0|0.8|2.28|||Regression, Logistic|||"Week 3~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||2.28|0.80|0.264
72355725|NCT03084796|144228623|SUPERIORITY||Odds Ratio (OR)|1.29||||0.343|TWO_SIDED|95.0|0.76|2.18|||Regression, Logistic|||"Week 3~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||2.18|0.76|0.343
72355726|NCT03084796|144228623|SUPERIORITY||Odds Ratio (OR)|1.74||||0.042|TWO_SIDED|95.0|1.02|2.98|||Regression, Logistic|||"Week 3~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||2.98|1.02|0.042
72355727|NCT03084796|144228623|SUPERIORITY||Odds Ratio (OR)|1.2||||0.503|TWO_SIDED|95.0|0.71|2.02|||Regression, Logistic|||"Week 3~Comparison treatment groups for this analysis were:~Treatment F (Tiotropium 18 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||2.02|0.71|0.503
72355728|NCT03084796|144228623|SUPERIORITY||Odds Ratio (OR)|1.28||||0.354|TWO_SIDED|95.0|0.76|2.16|||Regression, Logistic|||"Week 3~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||2.16|0.76|0.354
72355729|NCT03084796|144228623|SUPERIORITY||Odds Ratio (OR)|1.22||||0.447|TWO_SIDED|95.0|0.73|2.07|||Regression, Logistic|||"Week 3~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||2.07|0.73|0.447
72355730|NCT03084796|144228623|SUPERIORITY||Odds Ratio (OR)|1.66||||0.064|TWO_SIDED|95.0|0.97|2.83|||Regression, Logistic|||"Week 3~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||2.83|0.97|0.064
72355731|NCT03084796|144228623|SUPERIORITY||Odds Ratio (OR)|0.96||||0.867|TWO_SIDED|95.0|0.57|1.62|||Regression, Logistic|||"Week 3~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||1.62|0.57|0.867
72355732|NCT03084796|144228623|SUPERIORITY||Odds Ratio (OR)|1.29||||0.347|TWO_SIDED|95.0|0.76|2.22|||Regression, Logistic|||"Week 3~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||2.22|0.76|0.347
72355733|NCT03084796|144228623|SUPERIORITY||Odds Ratio (OR)|1.35||||0.269|TWO_SIDED|95.0|0.79|2.32|||Regression, Logistic|||"Week 3~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment C (CHF 5259 pMDI 50 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||2.32|0.79|0.269
72355734|NCT03084796|144228623|SUPERIORITY||Odds Ratio (OR)|1.92||||0.018|TWO_SIDED|95.0|1.12|3.3|||Regression, Logistic|||"Week 6~Comparison treatment groups for this analysis were:~Treatment A (CHF 5259 pMDI 12.5 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure.~Analysis based on logistic regression model - multiple logistic regression model, with treatment, US regions, smoking status at screening, and BDI as covariates."||3.30|1.12|0.018
72355735|NCT03084796|144228623|SUPERIORITY||Odds Ratio (OR)|2.59|||<|0.001|TWO_SIDED|95.0|1.5|4.49|||Regression, Logistic|||"Week 6~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||4.49|1.50|<0.001
72355736|NCT03084796|144228623|SUPERIORITY||Odds Ratio (OR)|3.08|||<|0.001|TWO_SIDED|95.0|1.75|5.44|||Regression, Logistic|||"Week 6~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||5.44|1.75|<0.001
72355737|NCT03084796|144228623|SUPERIORITY||Odds Ratio (OR)|3.42|||<|0.001|TWO_SIDED|95.0|1.94|6.02|||Regression, Logistic|||"Week 6~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||6.02|1.94|<0.001
72355738|NCT03084796|144228623|SUPERIORITY||Odds Ratio (OR)|2.45||||0.001|TWO_SIDED|95.0|1.41|4.26|||Regression, Logistic|||"Week 6~Comparison treatment groups for this analysis were:~Treatment F (Tiotropium 18 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||4.26|1.41|0.001
72355739|NCT03084796|144228623|SUPERIORITY||Odds Ratio (OR)|1.35||||0.284|TWO_SIDED|95.0|0.78|2.35|||Regression, Logistic|||"Week 6~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||2.35|0.78|0.284
72355740|NCT03084796|144228623|SUPERIORITY||Odds Ratio (OR)|1.61||||0.103|TWO_SIDED|95.0|0.91|2.84|||Regression, Logistic|||"Week 6~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||2.84|0.91|0.103
72355741|NCT03084796|144228623|SUPERIORITY||Odds Ratio (OR)|1.78||||0.045|TWO_SIDED|95.0|1.01|3.14|||Regression, Logistic|||"Week 6~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||3.14|1.01|0.045
72355742|NCT03084796|144228623|SUPERIORITY||Odds Ratio (OR)|1.19||||0.557|TWO_SIDED|95.0|0.67|2.12|||Regression, Logistic|||"Week 6~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||2.12|0.67|0.557
72355743|NCT03084796|144228623|SUPERIORITY||Odds Ratio (OR)|1.32||||0.345|TWO_SIDED|95.0|0.74|2.34|||Regression, Logistic|||"Week 6~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||2.34|0.74|0.345
72355744|NCT03084796|144228623|SUPERIORITY||Odds Ratio (OR)|1.11||||0.732|TWO_SIDED|95.0|0.61|2.0|||Regression, Logistic|||"Week 6~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment C (CHF 5259 pMDI 50 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||2.00|0.61|0.732
72355745|NCT03084796|144228624|SUPERIORITY||Mean Difference (Final Values)|0.15||||0.666|TWO_SIDED|95.0|-0.52|0.81|||Mixed Models Analysis|||"Week 3~Comparison treatment groups for this analysis were:~Treatment A (CHF 5259 pMDI 12.5 μg TDD) versus Treatment E (Placebo).~Analyzed using linear mixed model repeated for measurements (MMRM), including treatment, visit, treatment by visit interaction, US regions (Midwest, Northeast, South and West), and smoking status at screening as fixed effects, and the BDI, BDI by visit interaction as covariates."||0.81|-0.52|0.666
72355746|NCT03084796|144228624|SUPERIORITY||Mean Difference (Final Values)|0.41||||0.224|TWO_SIDED|95.0|-0.25|1.07|||Mixed Models Analysis|||"week 3~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||1.07|-0.25|0.224
72355747|NCT03084796|144228624|SUPERIORITY||Mean Difference (Final Values)|0.4||||0.239|TWO_SIDED|95.0|-0.27|1.06|||Mixed Models Analysis|||"Week 3~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||1.06|-0.27|0.239
72355748|NCT03084796|144228624|SUPERIORITY||Mean Difference (Final Values)|0.8||||0.019|TWO_SIDED|95.0|0.13|1.46|||Mixed Models Analysis|||"Week 3~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||1.46|0.13|0.019
72355749|NCT03084796|144228624|SUPERIORITY||Mean Difference (Final Values)|0.52||||0.124|TWO_SIDED|95.0|-0.14|1.19|||Mixed Models Analysis|||"Week 3~Comparison treatment groups for this analysis were:~Treatment F (Tiotropium 18 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||1.19|-0.14|0.124
72355750|NCT03084796|144228624|SUPERIORITY||Mean Difference (Final Values)|0.26||||0.432|TWO_SIDED|95.0|-0.39|0.92|||Mixed Models Analysis|||"Week 3~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.92|-0.39|0.432
72355751|NCT03084796|144228624|SUPERIORITY||Mean Difference (Net)|0.25||||0.454|TWO_SIDED|95.0|-0.41|0.91|||Mixed Models Analysis|||"Week 3~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.91|-0.41|0.454
72355752|NCT03084796|144228624|SUPERIORITY||Mean Difference (Final Values)|0.65||||0.053|TWO_SIDED|95.0|-0.01|1.31|||Mixed Models Analysis|||"Week 3~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||1.31|-0.01|0.053
72355753|NCT03084796|144228624|SUPERIORITY||Mean Difference (Final Values)|-0.01||||0.973|TWO_SIDED|95.0|-0.67|0.65|||Mixed Models Analysis|||"Week 3~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.65|-0.67|0.973
72355754|NCT03084796|144228624|SUPERIORITY||Mean Difference (Final Values)|0.39||||0.247|TWO_SIDED|95.0|-0.27|1.04|||Mixed Models Analysis|||"Week 3~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||1.04|-0.27|0.247
72355755|NCT03084796|144228624|SUPERIORITY||Mean Difference (Final Values)|0.4||||0.235|TWO_SIDED|95.0|-0.26|1.06|||Mixed Models Analysis|||"Week 3~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment C (CHF 5259 pMDI 50 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||1.06|-0.26|0.235
72355756|NCT03084796|144228624|SUPERIORITY||Mean Difference (Final Values)|0.61||||0.071|TWO_SIDED|95.0|-0.05|1.28|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment A (CHF 5259 pMDI 12.5 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||1.28|-0.05|0.071
72355757|NCT03084796|144228624|SUPERIORITY||Mean Difference (Final Values)|0.98||||0.004|TWO_SIDED|95.0|0.32|1.64|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||1.64|0.32|0.004
72355758|NCT03084796|144228624|SUPERIORITY||Mean Difference (Final Values)|1.01||||0.003|TWO_SIDED|95.0|0.35|1.68|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||1.68|0.35|0.003
72355759|NCT03084796|144228624|SUPERIORITY||Mean Difference (Final Values)|1.52|||<|0.001|TWO_SIDED|95.0|0.86|2.18|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||2.18|0.86|<0.001
72355760|NCT03084796|144228624|SUPERIORITY||Mean Difference (Final Values)|1.08||||0.002|TWO_SIDED|95.0|0.41|1.75|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment F (Tiotropium 18 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||1.75|0.41|0.002
72355761|NCT03084796|144228624|SUPERIORITY||Mean Difference (Final Values)|0.37||||0.271|TWO_SIDED|95.0|-0.29|1.03|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||1.03|-0.29|0.271
72355762|NCT03084796|144228624|SUPERIORITY||Mean Difference (Final Values)|0.4||||0.235|TWO_SIDED|95.0|-0.26|1.06|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||1.06|-0.26|0.235
72355763|NCT03084796|144228624|SUPERIORITY||Mean Difference (Final Values)|0.9||||0.007|TWO_SIDED|95.0|0.25|1.56|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||1.56|0.25|0.007
72355764|NCT03084796|144228624|SUPERIORITY||Mean Difference (Final Values)|0.03||||0.923|TWO_SIDED|95.0|-0.63|0.69|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.69|-0.63|0.923
72355765|NCT03084796|144228624|SUPERIORITY||Mean Difference (Final Values)|0.53||||0.108|TWO_SIDED|95.0|-0.12|1.19|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||1.19|-0.12|0.108
72355766|NCT03084796|144228624|SUPERIORITY||Mean Difference (Final Values)|0.5||||0.134|TWO_SIDED|95.0|-0.16|1.16|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment C (CHF 5259 pMDI 50 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||1.16|-0.16|0.134
72355767|NCT03084796|144228625|SUPERIORITY||Mean Difference (Final Values)|7.88||||0.022|TWO_SIDED|95.0|1.13|14.63|||Mixed Models Analysis|||"Inter-Visit period 1~Comparison treatment groups for this analysis were:~Treatment A (CHF 5259 pMDI 12.5 μg TDD) versus Treatment E (Placebo).~Analyzed using linear mixed model repeated for measurements (MMRM), including inter-visit period, treatment by inter-visit period interaction, US regions (Midwest, Northeast, South and West), and smoking status at screening as fixed effects, and the baseline value, and baseline by inter-visit period interaction as covariates."||14.63|1.13|0.022
72355768|NCT03084796|144228625|SUPERIORITY||Mean Difference (Final Values)|6.78||||0.048|TWO_SIDED|95.0|0.07|13.48|||Mixed Models Analysis|||"Inter-Visit period 1~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||13.48|0.07|0.048
72355769|NCT03084796|144228625|SUPERIORITY||Mean Difference (Final Values)|6.65||||0.053|TWO_SIDED|95.0|-0.09|13.4|||Mixed Models Analysis|||"Inter-Visit period 1~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||13.40|-0.09|0.053
72355770|NCT03084796|144228625|SUPERIORITY||Mean Difference (Final Values)|9.29||||0.007|TWO_SIDED|95.0|2.55|16.04|||Mixed Models Analysis|||"Inter-Visit period 1~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||16.04|2.55|0.007
72355771|NCT03084796|144228625|SUPERIORITY||Mean Difference (Final Values)|4.61||||0.191|TWO_SIDED|95.0|-2.31|11.53|||Mixed Models Analysis|||"Inter-Visit period 1~Comparison treatment groups for this analysis were:~Treatment F (Tiotropium 18 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||11.53|-2.31|0.191
72355772|NCT03084796|144228625|SUPERIORITY||Mean Difference (Final Values)|-1.1||||0.747|TWO_SIDED|95.0|-7.8|5.6|||Mixed Models Analysis|||"Inter-Visit period 1~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||5.60|-7.80|0.747
72355773|NCT03084796|144228625|SUPERIORITY||Mean Difference (Final Values)|-1.23||||0.72|TWO_SIDED|95.0|-7.96|5.5|||Mixed Models Analysis|||"Inter-Visit period 1~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||5.50|-7.96|0.720
72355774|NCT03084796|144228625|SUPERIORITY||Mean Difference (Final Values)|1.41||||0.68|TWO_SIDED|95.0|-5.31|8.14|||Mixed Models Analysis|||"Inter-Visit period 1~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||8.14|-5.31|0.680
72355775|NCT03084796|144228625|SUPERIORITY||Mean Difference (Final Values)|-0.12||||0.971|TWO_SIDED|95.0|-6.82|6.57|||Mixed Models Analysis|||"Inter-Visit period 1~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||6.57|-6.82|0.971
72355776|NCT03084796|144228625|SUPERIORITY||Mean Difference (Final Values)|2.52||||0.46|TWO_SIDED|95.0|-4.17|9.21|||Mixed Models Analysis|||"Inter-Visit period 1~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||9.21|-4.17|0.460
72355777|NCT03084796|144228625|SUPERIORITY||Mean Difference (Final Values)|2.64||||0.441|TWO_SIDED|95.0|-4.09|9.37|||Mixed Models Analysis|||"Inter-Visit period 1~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment C (CHF 5259 pMDI 50 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||9.37|-4.09|0.441
72355778|NCT03084796|144228625|SUPERIORITY||Mean Difference (Final Values)|6.76||||0.07|TWO_SIDED|95.0|-0.55|14.08|||Mixed Models Analysis|||"Inter-Visit period 2~Comparison treatment groups for this analysis were:~Treatment A (CHF 5259 pMDI 12.5 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||14.08|-0.55|0.070
72355779|NCT03084796|144228625|SUPERIORITY||Mean Difference (Final Values)|8.44||||0.023|TWO_SIDED|95.0|1.16|15.72|||Mixed Models Analysis|||"Inter-Visit period 2~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||15.72|1.16|0.023
72355780|NCT03084796|144228625|SUPERIORITY||Mean Difference (Final Values)|6.96||||0.064|TWO_SIDED|95.0|-0.4|14.31|||Mixed Models Analysis|||"Inter-Visit period 2~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||14.31|-0.40|0.064
72355781|NCT03084796|144228625|SUPERIORITY||Mean Difference (Final Values)|11.08||||0.003|TWO_SIDED|95.0|3.79|18.38|||Mixed Models Analysis|||"Inter-Visit period 2~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||18.38|3.79|0.003
72355782|NCT03084796|144228625|SUPERIORITY||Mean Difference (Final Values)|4.2||||0.274|TWO_SIDED|95.0|-3.32|11.72|||Mixed Models Analysis|||"Inter-Visit period 2~Comparison treatment groups for this analysis were:~Treatment F (Tiotropium 18 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||11.72|-3.32|0.274
72355783|NCT03084796|144228625|SUPERIORITY||Mean Difference (Final Values)|1.68||||0.649|TWO_SIDED|95.0|-5.57|8.93|||Mixed Models Analysis|||"Inter-Visit period 2~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||8.93|-5.57|0.649
72355784|NCT03084796|144228625|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.958|TWO_SIDED|95.0|-7.12|7.51|||Mixed Models Analysis|||"Inter-Visit period 2~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||7.51|-7.12|0.958
72355785|NCT03084796|144228625|SUPERIORITY||Mean Difference (Final Values)|4.32||||0.242|TWO_SIDED|95.0|-2.93|11.58|||Mixed Models Analysis|||"Inter-Visit period 2~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||11.58|-2.93|0.242
72355786|NCT03084796|144228625|SUPERIORITY||Mean Difference (Final Values)|-1.48||||0.69|TWO_SIDED|95.0|-8.77|5.81|||Mixed Models Analysis|||"Inter-Visit period 2~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||5.81|-8.77|0.690
72355787|NCT03084796|144228625|SUPERIORITY||Mean Difference (Final Values)|2.64||||0.473|TWO_SIDED|95.0|-4.58|9.87|||Mixed Models Analysis|||"Inter-Visit period 2~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||9.87|-4.58|0.473
72355788|NCT03084796|144228625|SUPERIORITY||Mean Difference (Final Values)|4.13||||0.267|TWO_SIDED|95.0|-3.17|11.43|||Mixed Models Analysis|||"Inter-Visit period 2~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment C (CHF 5259 pMDI 50 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||11.43|-3.17|0.267
72355789|NCT03084796|144228625|SUPERIORITY||Mean Difference (Final Values)|7.32||||0.032|TWO_SIDED|95.0|0.65|13.99|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups for this analysis were:~Treatment A (CHF 5259 pMDI 12.5 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||13.99|0.65|0.032
72355790|NCT03084796|144228625|SUPERIORITY||Mean Difference (Final Values)|7.61||||0.025|TWO_SIDED|95.0|0.97|14.24|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||14.24|0.97|0.025
72355791|NCT03084796|144228625|SUPERIORITY||Mean Difference (Final Values)|6.8||||0.046|TWO_SIDED|95.0|0.12|13.49|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||13.49|0.12|0.046
72355792|NCT03084796|144228625|SUPERIORITY||Mean Difference (Final Values)|10.19||||0.003|TWO_SIDED|95.0|3.52|16.85|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||16.85|3.52|0.003
72355793|NCT03084796|144228625|SUPERIORITY||Mean Difference (Final Values)|4.4||||0.207|TWO_SIDED|95.0|-2.45|11.25|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups for this analysis were:~Treatment F (Tiotropium 18 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||11.25|-2.45|0.207
72355794|NCT03084796|144228625|SUPERIORITY||Mean Difference (Final Values)|0.29||||0.932|TWO_SIDED|95.0|-6.33|6.91|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||6.91|-6.33|0.932
72355795|NCT03084796|144228625|SUPERIORITY||Mean Difference (Final Values)|-0.52||||0.879|TWO_SIDED|95.0|-7.17|6.14|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||6.14|-7.17|0.879
72355796|NCT03084796|144228625|SUPERIORITY||Mean Difference (Final Values)|2.87||||0.396|TWO_SIDED|95.0|-3.77|9.5|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||9.50|-3.77|0.396
72355797|NCT03084796|144228625|SUPERIORITY||Mean Difference (Final Values)|-0.8||||0.812|TWO_SIDED|95.0|-7.44|5.83|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||5.83|-7.44|0.812
72355798|NCT03084796|144228625|SUPERIORITY||Mean Difference (Final Values)|2.58||||0.444|TWO_SIDED|95.0|-4.03|9.19|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||9.19|-4.03|0.444
72355799|NCT03084796|144228625|SUPERIORITY||Mean Difference (Final Values)|3.38||||0.319|TWO_SIDED|95.0|-3.27|10.04|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment C (CHF 5259 pMDI 50 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||10.04|-3.27|0.319
72355800|NCT03084796|144228626|SUPERIORITY||Mean Difference (Final Values)|-0.43|||<|0.001|TWO_SIDED|95.0|-0.67|-0.18|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups for this analysis were:~Treatment A (CHF 5259 pMDI 12.5 μg TDD) versus Treatment E (Placebo).~Analyzed, using linear mixed model repeated for measurements (MMRM), including treatment, inter-visit period, treatment by inter-visit period interaction, US regions (Midwest, Northeast, South and West), and smoking status at screening as fixed effects, and the baseline value, and baseline by inter-visit period interaction as covariates."||-0.18|-0.67|<0.001
72355801|NCT03084796|144228626|SUPERIORITY||Mean Difference (Final Values)|-0.28||||0.023|TWO_SIDED|95.0|-0.53|-0.04|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||-0.04|-0.53|0.023
72355802|NCT03084796|144228626|SUPERIORITY||Mean Difference (Final Values)|-0.23||||0.067|TWO_SIDED|95.0|-0.47|0.02|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.02|-0.47|0.067
72355803|NCT03084796|144228626|SUPERIORITY||Mean Difference (Final Values)|-0.42|||<|0.001|TWO_SIDED|95.0|-0.66|-0.17|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||-0.17|-0.66|<0.001
72355804|NCT03084796|144228626|SUPERIORITY||Mean Difference (Final Values)|-0.22||||0.084|TWO_SIDED|95.0|-0.47|0.03|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups for this analysis were:~Treatment F (Tiotropium 18 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.03|-0.47|0.084
72355805|NCT03084796|144228626|SUPERIORITY||Mean Difference (Final Values)|0.14||||0.243|TWO_SIDED|95.0|-0.1|0.39|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.39|-0.10|0.243
72355806|NCT03084796|144228626|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.112|TWO_SIDED|95.0|-0.05|0.44|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.44|-0.05|0.112
72355807|NCT03084796|144228626|SUPERIORITY||Mean Difference (Final Values)|0.01||||0.929|TWO_SIDED|95.0|-0.23|0.26|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.26|-0.23|0.929
72355808|NCT03084796|144228626|SUPERIORITY||Mean Difference (Final Values)|0.05||||0.668|TWO_SIDED|95.0|-0.19|0.3|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.30|-0.19|0.668
72355809|NCT03084796|144228626|SUPERIORITY||Mean Difference (Final Values)|-0.13||||0.281|TWO_SIDED|95.0|-0.38|0.11|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.11|-0.38|0.281
72355810|NCT03084796|144228626|SUPERIORITY||Mean Difference (Final Values)|-0.19||||0.134|TWO_SIDED|95.0|-0.43|0.06|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment C (CHF 5259 pMDI 50 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.06|-0.43|0.134
72355811|NCT03084796|144228626|SUPERIORITY||Mean Difference (Final Values)|-0.42||||0.003|TWO_SIDED|95.0|-0.7|-0.14|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups for this analysis were:~Treatment A (CHF 5259 pMDI 12.5 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||-0.14|-0.70|0.003
72355812|NCT03084796|144228626|SUPERIORITY||Mean Difference (Final Values)|-0.33||||0.02|TWO_SIDED|95.0|-0.61|-0.05|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||-0.05|-0.61|0.020
72355813|NCT03084796|144228626|SUPERIORITY||Mean Difference (Final Values)|-0.34||||0.017|TWO_SIDED|95.0|-0.62|-0.06|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||-0.06|-0.62|0.017
72355814|NCT03084796|144228626|SUPERIORITY||Mean Difference (Final Values)|-0.52|||<|0.001|TWO_SIDED|95.0|-0.8|-0.24|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||-0.24|-0.80|<0.001
72355815|NCT03084796|144228626|SUPERIORITY||Mean Difference (Final Values)|-0.23||||0.115|TWO_SIDED|95.0|-0.52|0.06|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups for this analysis were:~Treatment F (Tiotropium 18 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.06|-0.52|0.115
72355816|NCT03084796|144228626|SUPERIORITY||Mean Difference (Final Values)|0.09||||0.532|TWO_SIDED|95.0|-0.19|0.36|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.36|-0.19|0.532
72355817|NCT03084796|144228626|SUPERIORITY||Mean Difference (Final Values)|0.07||||0.603|TWO_SIDED|95.0|-0.21|0.35|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.35|-0.21|0.603
72355818|NCT03084796|144228626|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.46|TWO_SIDED|95.0|-0.38|0.17|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.17|-0.38|0.460
72355819|NCT03084796|144228626|SUPERIORITY||Mean Difference (Final Values)|-0.01||||0.921|TWO_SIDED|95.0|-0.29|0.26|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD.~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.26|-0.29|0.921
72355820|NCT03084796|144228626|SUPERIORITY||Mean Difference (Final Values)|-0.19||||0.172|TWO_SIDED|95.0|-0.47|0.08|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.08|-0.47|0.172
72355821|NCT03084796|144228626|SUPERIORITY||Mean Difference (Final Values)|-0.18||||0.21|TWO_SIDED|95.0|-0.46|0.1|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment C (CHF 5259 pMDI 50 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.10|-0.46|0.210
72355822|NCT03084796|144228626|SUPERIORITY||Mean Difference (Final Values)|-0.42|||<|0.001|TWO_SIDED|95.0|-0.67|-0.17|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups for this analysis were:~Treatment A (CHF 5259 pMDI 12.5 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||-0.17|-0.67|<0.001
72355823|NCT03084796|144228626|SUPERIORITY||Mean Difference (Final Values)|-0.31||||0.016|TWO_SIDED|95.0|-0.55|-0.06|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||-0.06|-0.55|0.016
72355824|NCT03084796|144228626|SUPERIORITY||Mean Difference (Final Values)|-0.29||||0.025|TWO_SIDED|95.0|-0.54|-0.04|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||-0.04|-0.54|0.025
72355825|NCT03084796|144228626|SUPERIORITY||Mean Difference (Final Values)|-0.47|||<|0.001|TWO_SIDED|95.0|-0.72|-0.22|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||-0.22|-0.72|<0.001
72355826|NCT03084796|144228626|SUPERIORITY||Mean Difference (Final Values)|-0.23||||0.083|TWO_SIDED|95.0|-0.48|0.03|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups for this analysis were:~Treatment F (Tiotropium 18 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.03|-0.48|0.083
72355827|NCT03084796|144228626|SUPERIORITY||Mean Difference (Final Values)|0.12||||0.355|TWO_SIDED|95.0|-0.13|0.36|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.36|-0.13|0.355
72355828|NCT03084796|144228626|SUPERIORITY||Mean Difference (Final Values)|0.14||||0.283|TWO_SIDED|95.0|-0.11|0.38|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.38|-0.11|0.283
72355829|NCT03084796|144228626|SUPERIORITY||Mean Difference (Final Values)|-0.05||||0.712|TWO_SIDED|95.0|-0.29|0.2|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.20|-0.29|0.712
72355830|NCT03084796|144228626|SUPERIORITY||Mean Difference (Final Values)|0.02||||0.877|TWO_SIDED|95.0|-0.23|0.27|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.27|-0.23|0.877
72355831|NCT03084796|144228626|SUPERIORITY||Mean Difference (Final Values)|-0.16||||0.195|TWO_SIDED|95.0|-0.41|0.08|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.08|-0.41|0.195
72355832|NCT03084796|144228626|SUPERIORITY||Mean Difference (Final Values)|-0.18||||0.15|TWO_SIDED|95.0|-0.43|0.07|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment C (CHF 5259 pMDI 50 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.07|-0.43|0.150
72355833|NCT03084796|144228627|SUPERIORITY||Mean Difference (Final Values)|-0.967||||0.016|TWO_SIDED|95.0|-1.753|-0.181|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups for this analysis were:~Treatment A (CHF 5259 pMDI 12.5 μg TDD) versus Treatment E (Placebo).~Analyzed using linear mixed model repeated for measurements (MMRM), including treatment, inter-visit period, treatment by inter-visit period interaction, US regions (Midwest, Northeast, South and West), and smoking status at screening as fixed effects, and the baseline value, and baseline by inter-visit period interaction as covariates."||-0.181|-1.753|0.016
72355834|NCT03084796|144228627|SUPERIORITY||Mean Difference (Final Values)|-0.824||||0.039|TWO_SIDED|95.0|-1.606|-0.043|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||-0.043|-1.606|0.039
72355835|NCT03084796|144228627|SUPERIORITY||Mean Difference (Final Values)|-1.227||||0.002|TWO_SIDED|95.0|-2.012|-0.441|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||-0.441|-2.012|0.002
72355836|NCT03084796|144228627|SUPERIORITY||Mean Difference (Final Values)|-0.949||||0.018|TWO_SIDED|95.0|-1.733|-0.164|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||-0.164|-1.733|0.018
72355837|NCT03084796|144228627|SUPERIORITY||Mean Difference (Final Values)|-0.566||||0.169|TWO_SIDED|95.0|-1.374|0.242|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups for this analysis were:~Treatment F (Tiotropium 18 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.242|-1.374|0.169
72355838|NCT03084796|144228627|SUPERIORITY||Mean Difference (Final Values)|0.142||||0.72|TWO_SIDED|95.0|-0.638|0.923|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.923|-0.638|0.720
72355839|NCT03084796|144228627|SUPERIORITY||Mean Difference (Final Values)|-0.26||||0.515|TWO_SIDED|95.0|-1.043|0.523|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.523|-1.043|0.515
72355840|NCT03084796|144228627|SUPERIORITY||Mean Difference (Final Values)|0.018||||0.963|TWO_SIDED|95.0|-0.764|0.8|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.800|-0.764|0.963
72355841|NCT03084796|144228627|SUPERIORITY||Mean Difference (Final Values)|-0.402||||0.311|TWO_SIDED|95.0|-1.182|0.377|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.377|-1.182|0.311
72355842|NCT03084796|144228627|SUPERIORITY||Mean Difference (Final Values)|-0.124||||0.754|TWO_SIDED|95.0|-0.903|0.654|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.654|-0.903|0.754
72355843|NCT03084796|144228627|SUPERIORITY||Mean Difference (Final Values)|0.278||||0.485|TWO_SIDED|95.0|-0.503|1.06|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment C (CHF 5259 pMDI 50 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||1.060|-0.503|0.485
72355844|NCT03084796|144228627|SUPERIORITY||Mean Difference (Final Values)|-1.349||||0.005|TWO_SIDED|95.0|-2.294|-0.403|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups for this analysis were:~Treatment A (CHF 5259 pMDI 12.5 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||-0.403|-2.294|0.005
72355845|NCT03084796|144228627|SUPERIORITY||Mean Difference (Final Values)|-1.159||||0.016|TWO_SIDED|95.0|-2.1|-0.218|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||-0.218|-2.100|0.016
72355846|NCT03084796|144228627|SUPERIORITY||Mean Difference (Final Values)|-1.466||||0.003|TWO_SIDED|95.0|-2.416|-0.516|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||-0.516|-2.416|0.003
72355847|NCT03084796|144228627|SUPERIORITY||Mean Difference (Final Values)|-1.396||||0.004|TWO_SIDED|95.0|-2.337|-0.454|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||-0.454|-2.337|0.004
72355848|NCT03084796|144228627|SUPERIORITY||Mean Difference (Final Values)|-0.824||||0.097|TWO_SIDED|95.0|-1.797|0.15|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups for this analysis were:~Treatment F (Tiotropium 18 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.150|-1.797|0.097
72355849|NCT03084796|144228627|SUPERIORITY||Mean Difference (Final Values)|0.19||||0.69|TWO_SIDED|95.0|-0.746|1.126|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||1.126|-0.746|0.690
72355850|NCT03084796|144228627|SUPERIORITY||Mean Difference (Final Values)|-0.117||||0.808|TWO_SIDED|95.0|-1.061|0.827|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.827|-1.061|0.808
72355851|NCT03084796|144228627|SUPERIORITY||Mean Difference (Final Values)|-0.047||||0.922|TWO_SIDED|95.0|-0.983|0.889|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.889|-0.983|0.922
72355852|NCT03084796|144228627|SUPERIORITY||Mean Difference (Final Values)|-0.307||||0.522|TWO_SIDED|95.0|-1.248|0.634|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.634|-1.248|0.522
72355853|NCT03084796|144228627|SUPERIORITY||Mean Difference (Final Values)|-0.237||||0.618|TWO_SIDED|95.0|-1.17|0.696|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.696|-1.170|0.618
72355854|NCT03084796|144228627|SUPERIORITY||Mean Difference (Final Values)|0.07||||0.884|TWO_SIDED|95.0|-0.871|1.012|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment C (CHF 5259 pMDI 50 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||1.012|-0.871|0.884
72355855|NCT03084796|144228627|SUPERIORITY||Mean Difference (Final Values)|-1.158||||0.006|TWO_SIDED|95.0|-1.978|-0.337|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups for this analysis were:~Treatment A (CHF 5259 pMDI 12.5 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||-0.337|-1.978|0.006
72355856|NCT03084796|144228627|SUPERIORITY||Mean Difference (Final Values)|-0.992||||0.017|TWO_SIDED|95.0|-1.808|-0.175|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||-0.175|-1.808|0.017
72355857|NCT03084796|144228627|SUPERIORITY||Mean Difference (Final Values)|-1.346||||0.001|TWO_SIDED|95.0|-2.168|-0.524|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||-0.524|-2.168|0.001
72355858|NCT03084796|144228627|SUPERIORITY||Mean Difference (Final Values)|-1.172||||0.005|TWO_SIDED|95.0|-1.991|-0.353|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||-0.353|-1.991|0.005
72355859|NCT03084796|144228627|SUPERIORITY||Mean Difference (Final Values)|-0.695||||0.107|TWO_SIDED|95.0|-1.539|0.149|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups for this analysis were:~Treatment F (Tiotropium 18 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.149|-1.539|0.107
72355860|NCT03084796|144228627|SUPERIORITY||Mean Difference (Final Values)|0.166||||0.689|TWO_SIDED|95.0|-0.648|0.98|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.980|-0.648|0.689
72355861|NCT03084796|144228627|SUPERIORITY||Mean Difference (Final Values)|-0.188||||0.651|TWO_SIDED|95.0|-1.007|0.63|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.630|-1.007|0.651
72355862|NCT03084796|144228627|SUPERIORITY||Mean Difference (Final Values)|-0.014||||0.973|TWO_SIDED|95.0|-0.83|0.801|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.801|-0.830|0.973
72355863|NCT03084796|144228627|SUPERIORITY||Mean Difference (Final Values)|-0.355||||0.393|TWO_SIDED|95.0|-1.17|0.461|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.461|-1.170|0.393
72355864|NCT03084796|144228627|SUPERIORITY||Mean Difference (Final Values)|-0.181||||0.663|TWO_SIDED|95.0|-0.993|0.632|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.632|-0.993|0.663
72355865|NCT03084796|144228627|SUPERIORITY||Mean Difference (Final Values)|0.174||||0.676|TWO_SIDED|95.0|-0.643|0.991|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment C (CHF 5259 pMDI 50 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.991|-0.643|0.676
72355866|NCT02741245|144228659|OTHER||Difference in M-estimates|-35.9|||<|0.001|TWO_SIDED|95.0|-39.9|-32.0|||Shapiro-Wilk test|Robust regression model with terms for treatment, risk category and baseline, after imputing missing values by a multiple imputation approach||||-32.0|-39.9|<0.001
72355867|NCT02741245|144228659|OTHER|Robust regression model with terms for treatment, risk category and baseline, after imputing missing values by a multiple imputation approach|Difference in M-estimates|-14.8|||<|0.001|TWO_SIDED|95.0|-18.0|-11.6|||Shapiro-Wilk test|||||-11.6|-18.0|<0.001
72355868|NCT02741245|144228659|OTHER|Robust regression model with terms for treatment, risk category and baseline, after imputing missing values by a multiple imputation approach|Difference in M-estimates|-41.8|||<|0.001|TWO_SIDED|95.0|-45.8|-37.9|||Shapiro-Wilk test|||||-37.9|-45.8|<0.001
72355869|NCT02741245|144228659|OTHER|Robust regression model with terms for treatment, risk category and baseline, after imputing missing values by a multiple imputation approach|Differecne in M-estimates|-13.3|||<|0.001|TWO_SIDED|95.0|-16.6|-10.1|||Shapiro-Wilk test|||||-10.1|-16.6|<0.001
72355870|NCT01650194|144228701|OTHER|||||||0.615|||||||t-test, 2 sided|||Testosterone biomarker results collected at baseline and at Week 9 were compared using the paired t-test to evaluate the effect of enzalutamide.||||0.6150
72355871|NCT01650194|144228703|OTHER||||||<|0.0001|||||||t-test, 2 sided|||Cortisol biomarker results collected at baseline and at Week 9 were compared using the paired t-test to evaluate the effect of enzalutamide.||||<.0001
72355872|NCT01650194|144228704|OTHER||||||<|0.0001|||||||t-test, 2 sided|||Androstenedione biomarker results collected at baseline and at Week 9 were compared using the paired t-test to evaluate the effect of enzalutamide.||||<.0001
72355873|NCT01650194|144228705|OTHER||||||<|0.0001|||||||t-test, 2 sided|||Progesterone biomarker results collected at baseline and at Week 9 were compared using the paired t-test to evaluate the effect of enzalutamide.||||<.0001
72355874|NCT01650194|144228706|OTHER||||||<|0.0001|||||||t-test, 2 sided|||Pregnenolone biomarker results collected at baseline and at Week 9 were compared using the paired t-test to evaluate the effect of enzalutamide.||||<.0001
72355875|NCT01650194|144228707|OTHER||||||<|0.0001|||||||t-test, 2 sided|||Testosterone blood results collected at baseline and at Week 9 were compared using the paired t-test to evaluate the effect of enzalutamide.||||<.0001
72355876|NCT01650194|144228709|OTHER||||||<|0.0001|||||||t-test, 2 sided|||Cortisol blood results collected at baseline and at Week 9 were compared using the paired t-test to evaluate the effect of enzalutamide.||||<.0001
72355877|NCT01650194|144228710|OTHER||||||<|0.0001|||||||t-test, 2 sided|||Androstenedione blood results collected at baseline and at Week 9 were compared using the paired t-test to evaluate the effect of enzalutamide.||||<.0001
72355878|NCT01650194|144228711|OTHER|||||||0.0002|||||||t-test, 2 sided|||Progesterone blood results collected at baseline and at Week 9 were compared using the paired t-test to evaluate the effect of enzalutamide.||||0.0002
72355879|NCT01650194|144228712|OTHER||||||<|0.0001|||||||t-test, 2 sided|||Pregnenolone blood results collected at baseline and at Week 9 were compared using the paired t-test to evaluate the effect of enzalutamide.||||<.0001
72355880|NCT00880698|144228744|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|-3.1||||0.62|TWO_SIDED|95.0|-20.6|14.8||The pre-specified significance level was 5%. No adjustments were made for multiple comparisons.|Fisher Exact||Difference and 95% confidence interval (RotaTeq minus Placebo) in percentage of HIV-uninfected participants experiencing a new grade \>=3 adverse event|||14.8|-20.6|0.62
72355881|NCT00880698|144228744|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|0.7||||1|TWO_SIDED|95.0|-21.0|23.4||The pre-specified significance level was 5%. No adjustments were made for multiple comparisons.|Fisher Exact||Difference and 95% confidence interval (RotaTeq minus Placebo) in percentage of HIV-infected participants experiencing a new grade \>=3 adverse event|||23.4|-21.0|1.00
72355882|NCT00880698|144228745|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|29.9|||<|0.001|TWO_SIDED|95.0|11.5|46.1||The pre-specified significance level was 5%. No adjustments were made for multiple comparisons.|Fisher Exact||Difference (95% confidence interval) in percentage of HIV-1 uninfected participants classified as responders for SNA G1 in RotaTeq group minus Placebo group.|SNA G1||46.1|11.5|<0.001
72355883|NCT00880698|144228745|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|49.8|||<|0.001|TWO_SIDED|95.0|27.1|68.6||The pre-specified significance level was 5%. No adjustments were made for multiple comparisons.|Fisher Exact||Difference (95% confidence interval) in percentage of HIV-1 infected participants classified as responders for SNA G1 in RotaTeq group minus Placebo group.|SNA G1||68.6|27.1|<0.001
72355884|NCT00880698|144228745|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|7.1||||0.2|TWO_SIDED|95.0|-11.3|24.8||The pre-specified significance level was 5%. No adjustments were made for multiple comparisons.|Fisher Exact||Difference (95% confidence interval) in percentage of HIV-1 uninfected participants classified as responders for SNA G2 in RotaTeq group minus Placebo group.|SNA G2||24.8|-11.3|0.20
72355885|NCT00880698|144228745|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|14.2||||0.19|TWO_SIDED|95.0|-10.6|36.7||The pre-specified significance level was 5%. No adjustments were made for multiple comparisons.|Fisher Exact||Difference (95% confidence interval) in percentage of HIV-1 infected participants classified as responders for SNA G2 in RotaTeq group minus Placebo group.|SNA G2||36.7|-10.6|0.19
72355886|NCT00880698|144228745|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|19.3|||<|0.001|TWO_SIDED|95.0|0.9|36.4||The pre-specified significance level was 5%. No adjustments were made for multiple comparisons.|Fisher Exact||Difference (95% confidence interval) in percentage of HIV-1 uninfected participants classified as responders for SNA G3 in RotaTeq group minus Placebo group.|SNA G3||36.4|0.9|<0.001
72355887|NCT00880698|144228745|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|29.4|||<|0.001|TWO_SIDED|95.0|4.7|50.6||The pre-specified significance level was 5%. No adjustments were made for multiple comparisons.|Fisher Exact||Difference (95% confidence interval) in percentage of HIV-1 infected participants classified as responders for SNA G3 in RotaTeq group minus Placebo group.|SNA G3||50.6|4.7|<0.001
72355888|NCT00880698|144228745|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|26.4|||<|0.001|TWO_SIDED|95.0|8.0|42.9||The pre-specified significance level was 5%. No adjustments were made for multiple comparisons.|Fisher Exact||Difference (95% confidence interval) in percentage of HIV-1 uninfected participants classified as responders for SNA G4 in RotaTeq group minus Placebo group.|SNA G4||42.9|8.0|<0.001
72355889|NCT00880698|144228745|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|58.6|||<|0.001|TWO_SIDED|95.0|37.2|75.9||The pre-specified significance level was 5%. No adjustments were made for multiple comparisons.|Fisher Exact||Difference (95% confidence interval) in percentage of HIV-1 infected participants classified as responders for SNA G4 in RotaTeq group minus Placebo group.|SNA G4||75.9|37.2|<0.001
72355890|NCT00880698|144228745|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|16.4||||0.024|TWO_SIDED|95.0|-1.7|34.2||The pre-specified significance level was 5%. No adjustments were made for multiple comparisons.|Fisher Exact||Difference (95% confidence interval) in percentage of HIV-1 uninfected participants classified as responders for SNA P1 in RotaTeq group minus Placebo group.|SNA P1||34.2|-1.7|0.024
72355891|NCT00880698|144228745|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|11.7||||0.34|TWO_SIDED|95.0|-12.0|35.5||The pre-specified significance level was 5%. No adjustments were made for multiple comparisons.|Fisher Exact||Difference (95% confidence interval) in percentage of HIV-1 infected participants classified as responders for SNA P1 in RotaTeq group minus Placebo group.|SNA P1||35.5|-12.0|0.34
72355892|NCT00880698|144228745|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|51.4|||<|0.001|TWO_SIDED|95.0|34.3|66.3||The pre-specified significance level was 5%. No adjustments were made for multiple comparisons.|Fisher Exact||Difference (95% confidence interval) in percentage of HIV-1 uninfected participants classified as responders for IgA in RotaTeq group minus Placebo group.|IgA||66.3|34.3|<0.001
72355893|NCT00880698|144228745|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|65.1|||<|0.001|TWO_SIDED|95.0|42.7|81.7||The pre-specified significance level was 5%. No adjustments were made for multiple comparisons.|Fisher Exact||Difference (95% confidence interval) in percentage of HIV-1 infected participants classified as responders for IgA in RotaTeq group minus Placebo group.|IgA||81.7|42.7|<0.001
72355894|NCT00851786|144228812|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.57|STANDARD_ERROR_OF_MEAN|0.06|<|0.001|TWO_SIDED|95.0|0.45|0.69||The p-value was adjusted for baseline gpELISA titer, measurement time (week 6 vs. week 12), CD4 stratum and age.|Linear mixed effect model|Natural log transformed gpELISA titers after one or two doses of vaccine was modeled.||Null hypothesis: VZV antibody titer measured by gpELISA, after 1 or 2 doses of ZOSTAVAX/placebo is the same between ZOSTAVAX arm and the placebo arm||0.69|0.45|<.001
72355895|NCT02649556|144228814|OTHER||LS Mean Difference|1.75|||||TWO_SIDED|95.0|-0.16|3.65||||||"The analysis will determine the effect of THS 2.2 compared to CC at Month 12 on the components of the smokers' health profile. This study has no formal pre-specified hypotheses associated with the study objectives. Estimates of THS 2.2 effect will be presented by mean of LS Mean difference of HDL-C levels between CC and THS 2.2 and related 95% CI."|Mixed model conducted on original values with visit, baseline value and its interaction with visit, sex, Caucasian origin, product use pattern category and its interaction with visit, and other baseline covariates relevant for the specific clinical risk endpoint as fixed effect factors and site as a random effect.|3.65|-0.160|
72355896|NCT02649556|144228815|OTHER||LS Mean Difference|-0.413|||||TWO_SIDED|95.0|-0.694|-0.131||||||"The analysis will determine the effect of THS 2.2 compared to CC at Month 12 on the components of the smokers' health profile. This study has no formal pre-specified hypotheses associated with the study objectives. Estimates of THS 2.2 effect will be presented by mean of LS Mean difference of White Blood Cell counts between CC and THS 2.2 and related 95% CI."|Mixed model conducted on original values with visit, baseline value and its interaction with visit, sex, Caucasian origin, product use pattern category and its interaction with visit, and other baseline covariates relevant for the specific clinical risk endpoint as fixed effect factors and site as a random effect.|-0.131|-0.694|
72355897|NCT02649556|144228816|OTHER||LS Mean Difference|0.914|||||TWO_SIDED|95.0|-0.339|2.17||||||"The analysis will determine the effect of THS 2.2 compared to CC at Month 12 on the components of the smokers' health profile. This study has no formal pre-specified hypotheses associated with the study objectives. Estimates of THS 2.2 effect will be presented by mean of LS Mean difference of FEV1 levels between CC and THS 2.2 and related 95% CI."|Mixed model conducted on original values with visit, baseline value and its interaction with visit, sex, Caucasian origin, product use pattern category and its interaction with visit, and other baseline covariates relevant for the specific clinical risk endpoint as fixed effect factors and site as a random effect.|2.17|-0.339|
72355898|NCT02649556|144228817|OTHER||% Relative Reduction|3.11|||||TWO_SIDED|95.0|0.0231|6.1|||||Derived as 100 x (1 - Geometric LS Mean Ratio)|"The analysis will determine the effect of THS 2.2 compared to CC at Month 12 on the components of the smokers' health profile. This study has no formal pre-specified hypotheses associated with the study objectives. Estimates of THS 2.2 effect will be presented by mean of relative reduction of sICAM-1 levels between CC and THS 2.2 and related 95% CI."|Mixed model conducted on log-transformed values with visit, log-transformed baseline value and its interaction with visit, sex, Caucasian origin, product use pattern category and its interaction with visit, and other baseline covariates relevant for the specific clinical risk endpoint as fixed effect factors and site as a random effect|6.10|0.0231|
72355899|NCT02649556|144228818|OTHER||% Relative Reduction|3.44|||||TWO_SIDED|95.0|-8.74|14.3|||||Derived as 100 x (1-Geometric LS Mean Ratio)|"The analysis will determine the effect of THS 2.2 compared to CC at Month 12 on the components of the smokers' health profile. This study has no formal pre-specified hypotheses associated with the study objectives. Estimates of THS 2.2 effect will be presented by mean of relative reduction of 11-DTXB2 levels between CC and THS 2.2 and related 95% CI."|Mixed model conducted on log-transformed values with visit, log-transformed baseline value and its interaction with visit, sex, Caucasian origin, product use pattern category and its interaction with visit, and other baseline covariates relevant for the specific clinical risk endpoint as fixed effect factors and site as a random effect|14.3|-8.74|
72355900|NCT02649556|144228819|OTHER||% Relative Reduction|7.15|||||TWO_SIDED|95.0|-1.03|14.7|||||Derived as 100 x (1 - Geometric LS Mean Ratio)|"The analysis will determine the effect of THS 2.2 compared to CC at Month 12 on the components of the smokers' health profile. This study has no formal pre-specified hypotheses associated with the study objectives. Estimates of THS 2.2 effect will be presented by mean of relative reduction of 8-epi-PGF2α levels between CC and THS 2.2 and related 95% CI."|Mixed model conducted on log-transformed values with visit, log-transformed baseline value and its interaction with visit, sex, Caucasian origin, product use pattern category and its interaction with visit, and other baseline covariates relevant for the specific clinical risk endpoint as fixed effect factors and site as a random effect.|14.7|-1.03|
72355901|NCT02649556|144228820|OTHER||% Relative Reduction|46.3|||||TWO_SIDED|95.0|36.2|54.8|||||Derived as 100 x (1 - Geometric LS Mean Ratio)|"The analysis will determine the effect of THS 2.2 compared to CC at Month 12 on the components of the smokers' health profile. This study has no formal pre-specified hypotheses associated with the study objectives. Estimates of THS 2.2 effect will be presented by mean of relative reduction of Total NNAL levels between CC and THS 2.2 and related 95% CI."|Mixed model conducted on log-transformed values with visit, log-transformed baseline value and its interaction with visit, sex, Caucasian origin, product use pattern category and its interaction with visit, and other baseline covariates relevant for the specific clinical risk endpoint as fixed effect factors and site as a random effect|54.8|36.2|
72355902|NCT02649556|144228821|OTHER||% Relative Reduction|31.7|||||TWO_SIDED|95.0|23.3|39.1|||||Derived as 100 x (1 - Geometric LS Mean Ratio)|"The analysis will determine the effect of THS 2.2 compared to CC at Month 12 on the components of the smokers' health profile. This study has no formal pre-specified hypotheses associated with the study objectives. Estimates of THS 2.2 effect will be presented by mean of relative reduction of COHb levels between CC and THS 2.2 and related 95% CI."|Mixed model conducted on log-transformed values with visit, log-transformed baseline value and its interaction with visit, sex, Caucasian origin, product use pattern category and its interaction with visit, and other baseline covariates relevant for the specific clinical risk endpoint as fixed effect factors and site as a random effect.|39.1|23.3|
72355903|NCT04290039|144228822|OTHER|Estimation only|Geometric ratio of least-square means|0.579|||||TWO_SIDED|90.0|0.5265|0.636|||Mixed Models Analysis||Only subjects who had at least 2 periods where study drug was received with an evaluable PK profile were included in the comparisons.|||0.6360|0.5265|
72355904|NCT04290039|144228822|OTHER|Estimation only|Geometric ratio of least-square means|0.349|||||TWO_SIDED|90.0|0.3171|0.3839|||Mixed Models Analysis||Only subjects who had at least 2 periods where study drug was received with an evaluable PK profile were included in the comparisons.|||0.3839|0.3171|
72355905|NCT04290039|144228822|OTHER|Estimation only|Geometric ratio of least-square means|0.603|||||TWO_SIDED|90.0|0.5524|0.6582|||Mixed Models Analysis||Only subjects who had at least 2 periods where study drug was received with an evaluable PK profile were included in the comparisons.|||0.6582|0.5524|
72355906|NCT04290039|144228823|OTHER|Estimation only|Geometric ratio of least-square means|0.546|||||TWO_SIDED|90.0|0.4971|0.6004|||Mixed Models Analysis||Only subjects who had at least 2 periods where study drug was received with an evaluable PK profile were included in the comparisons.|||0.6004|0.4971|
72355907|NCT04290039|144228823|OTHER|Estimation only|Geometric ratio of least-square means|0.306|||||TWO_SIDED|90.0|0.2788|0.3367|||Mixed Models Analysis||Only subjects who had at least 2 periods where study drug was received with an evaluable PK profile were included in the comparisons.|||0.3367|0.2788|
72355908|NCT04290039|144228823|OTHER|Estimation only|Geometric ratio of least-square means|0.561|||||TWO_SIDED|90.0|0.5104|0.6164|||Mixed Models Analysis||Only subjects who had at least 2 periods where study drug was received with an evaluable PK profile were included in the comparisons.|||0.6164|0.5104|
72355909|NCT04290039|144228824|OTHER|Estimation only|Geometric ratio of least-square means|0.549|||||TWO_SIDED|90.0|0.4273|0.7118|||Mixed Models Analysis||Only subjects who had at least 2 periods where study drug was received with an evaluable PK profile were included in the comparisons.|||0.7118|0.4273|
72355910|NCT04290039|144228824|OTHER|Estimation only|Geometric ratio of least-square means|0.049|||||TWO_SIDED|90.0|0.0381|0.0641|||Mixed Models Analysis||Only subjects who had at least 2 periods where study drug was received with an evaluable PK profile were included in the comparisons.|||0.0641|0.0381|
72355911|NCT04290039|144228824|OTHER|Estimation only|Geometric ratio of least-square means|0.09|||||TWO_SIDED|90.0|0.0695|0.1167|||Mixed Models Analysis||Only subjects who had at least 2 periods where study drug was received with an evaluable PK profile were included in the comparisons.|||0.1167|0.0695|
72355912|NCT01690052|144228877|SUPERIORITY_OR_OTHER|||||||0.05|||||||ANOVA|The p-value is calculated from the ANOVA||||||0.05
72355913|NCT01173016|144228894|OTHER|||||||0.038|||||||Regression, Logistic|||Impact of anti-laronidase antibody status on the change in 6MWT outcome was tested||||0.038
72355914|NCT00657540|144228895|SUPERIORITY_OR_OTHER|||||||0.0185|||||||Chi-squared|The proportion of treatment failures was compared between groups using a one-sided test at the 0.025 level of significance.||||||0.0185
72355915|NCT00657540|144228896|SUPERIORITY_OR_OTHER|||||||0.2302|||||||Chi-squared|Chi-squared tests at the 0.025 level of significance were used to test for a difference in proportions between the treatment groups.||||||0.2302
72355916|NCT00657540|144228897|SUPERIORITY_OR_OTHER|||||||0.8213|||||||Chi-squared|The proportion of subjects with at least one drug-related adverse event by treatment groups using a two-sided test at the 0.05 level of significance.||||||0.8213
72355917|NCT00657540|144228898|SUPERIORITY_OR_OTHER|||||||0.2765|||||||Chi-squared|The proportion of subjects with decreased pain at any time point between treatment groups using a one-sided test at the 0.025 level of significance.||||||0.2765
72355918|NCT01169103|144228902|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7||95.0|||||t-test, 2 sided|||We assumed that mean decrease in visceral fat in our population would be 0.85\*standard deviation score (SDS). Therefore, 18 subjects in each group would be required in order for us to have an 81.7% chance of detecting a significant difference in the mean 6-month changes in visceral adiposity between the groups at a 5% significance level by rejecting the null hypothesis that there is no difference in change in visceral fat following administration of rhGH or placebo in obese adolescent girls.||||0.70
72355919|NCT01169103|144228902|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3|||||||t-test, 2 sided|||Change in SAT p-value||||0.30
72355920|NCT01169103|144228903|SUPERIORITY_OR_OTHER_LEGACY|||||||0.93||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.93
72355921|NCT01169103|144228904|SUPERIORITY_OR_OTHER_LEGACY|||||||0.03||95.0|||||t-test, 2 sided|||Change in Total Cholesterol p-value||||0.03
72355922|NCT01169103|144228904|SUPERIORITY_OR_OTHER_LEGACY|||||||0.57|||||||Wilcoxon (Mann-Whitney)|||Change in Triglyceride p-value||||0.57
72355923|NCT01169103|144228904|SUPERIORITY_OR_OTHER_LEGACY|||||||0.062|||||||t-test, 2 sided|||Change in Low-density lipoprotein p-value||||0.062
72355924|NCT01169103|144228904|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0396|||||||t-test, 2 sided|||Change in High-density lipoprotein p-value||||0.0396
72355925|NCT01169103|144228905|SUPERIORITY_OR_OTHER_LEGACY|||||||0.58||95.0|||||t-test, 2 sided|||||||0.58
72355926|NCT01169103|144228906|SUPERIORITY_OR_OTHER_LEGACY|||||||0.04||95.0|||||t-test, 2 sided|||||||0.04
72355927|NCT02656017|144228910|SUPERIORITY||Mean Difference (Net)|0.07||||0.5|TWO_SIDED|95.0|-0.13|0.26|||Mixed Models Analysis|||Linear mixed model with random intercept was used to compare the change in GSRS score as a function of time, the interaction between time and study arm, and clinical site.||0.26|-0.13|0.50
72355928|NCT02656017|144228911|SUPERIORITY|||||||0.12|||||||Gray's test|||The Gray's test of homogeneity for competing risks was used to compare cumulative incidence of tolerating the drug between study arms.||||0.12
72355929|NCT02656017|144228912|SUPERIORITY|||||||0.98|||||||Regression, Logistic|||Cumulative incidence between study arms and logistic regression was used to assess the association between study arms.||||0.98
72355930|NCT02656017|144228913|SUPERIORITY||Mean Difference (Final Values)|0.4||||0.72|TWO_SIDED|95.0|-1.81|2.6|||Mixed Models Analysis|||Linear mixed model with random intercept was used to compare the change in SF-36 PCS as a function of time, the interaction between time and study arm, and clinical site.||2.60|-1.81|0.72
72355931|NCT02656017|144228914|SUPERIORITY||Mean Difference (Final Values)|1.11||||0.49|TWO_SIDED|95.0|-2.02|4.25|||Mixed Models Analysis|||Linear mixed model with random intercept was used to compare the change in SF-36 MCS as a function of time, the interaction between time and study arm, and clinical site.||4.25|-2.02|0.49
72355932|NCT02656017|144228915|SUPERIORITY|||||||0.44|||||||Mixed Models Analysis|||Generalized linear mixed model (logit link) with random intercept and slope was used to compare back pain frequency as a function of time, the interaction between time and study arm, and clinical site.||||0.44
72355933|NCT02656017|144228916|SUPERIORITY||Mean Difference (Final Values)|2.73||||0.2|TWO_SIDED|95.0|-1.4|6.87|||Mixed Models Analysis|||Linear mixed model with random intercept was used to compare the change in eGFR as a function of time, the interaction between time and study arm, and clinical site.||6.87|-1.40|0.20
72355934|NCT02656017|144228917|SUPERIORITY||Mean Difference (Final Values)|1.68||||0.38|TWO_SIDED|95.0|-2.11|5.62|||Mixed Models Analysis|||Linear mixed model with random intercept and slope was used to compare the annual percent change of ln(htTKV) as a function of time, the interaction between time and study arm, and clinical site.||5.62|-2.11|0.38
72355935|NCT02656017|144228918|SUPERIORITY||Mean Difference (Final Values)|3.81||||0.31|TWO_SIDED|95.0|-3.48|11.65|||Mixed Models Analysis|||Linear mixed model with random intercept and slope was used to compare the annual percent change of ln(htTKCV) as a function of time, the interaction between time and study arm, and clinical site.||11.65|-3.48|0.31
72355936|NCT02656017|144228919|SUPERIORITY||Mean Difference (Final Values)|0.39||||0.72|TWO_SIDED|95.0|-1.78|2.61|||Mixed Models Analysis|||Linear mixed model with random intercept and slope was used to compare the annual percent change of ln(htLV) as a function of time, the interaction between time and study arm, and clinical site.||2.61|-1.78|0.72
72355937|NCT02656017|144228920|SUPERIORITY||Mean Difference (Final Values)|1.6||||0.8|TWO_SIDED|95.0|-10.05|14.76|||Mixed Models Analysis|||Linear mixed model with random intercept and slope was used to compare the annual percent change of ln(htLCV) as a function of time, the interaction between time and study arm, and clinical site.||14.76|-10.05|0.80
72355938|NCT02656017|144228921|SUPERIORITY|||||||0.83|||||||Mixed Models Analysis|||Generalized linear mixed model (logit link) with random intercept and slope was used to compare abdominal fullness interfered as a function of time, the interaction between time and study arm, and clinical site.||||0.83
72355939|NCT02656017|144228922|SUPERIORITY|||||||0.72|||||||Mixed Models Analysis|||Generalized linear mixed model (logit link) with random intercept and slope was used to compare interference of pain with sleep frequency as a function of time, the interaction between time and study arm, and clinical site.||||0.72
72355940|NCT02656017|144228923|SUPERIORITY|||||||0.28|||||||Mixed Models Analysis|||Generalized linear mixed model (logit link) with random intercept and slope was used to compare interference of pain with strenuous physical activity frequency as a function of time, the interaction between time and study arm, and clinical site.||||0.28
72355941|NCT04755816|144228924|OTHER|Estimates and confidence intervals are provided|Win Ratio|1.29|||||TWO_SIDED|95.0|1.08|1.54||||||"Dietary Sodium Intervention includes those in treatment group B and D. No Dietary Sodium Intervention includes those in treatment group A and C. By the unmatched pairs win ratio method, each participant receiving the intervention will be compared to each participant not receiving the intervention. For each comparison, winners will be determined according to the hierarchy described above. The win ratio is the number winners divided by the number of losers associated with the intervention."||1.54|1.08|
72355942|NCT04755816|144228925|OTHER|Estimates and confidence intervals are provided|Win Ratio|1.29|||||TWO_SIDED|95.0|1.08|1.54||||||"Clinical Worsening Intervention includes those in treatment group C and D. No Clinical Worsening Intervention includes those in group A and B. By the unmatched pairs win ratio method, each participant receiving the intervention will be compared to each participant not receiving the intervention. For each comparison, winners will be determined according to the hierarchy described above. The win ratio is the number winners divided by the number of losers associated with the intervention."||1.54|1.08|
72355943|NCT04755816|144228927|OTHER|Estimates and confidence intervals are provided|Hazard Ratio (HR)|1.096|||||TWO_SIDED|95.0|0.321|3.743||||||Dietary Sodium Intervention includes those in treatment group B and D. No Dietary Sodium Intervention includes those in treatment group A and C.||3.743|0.321|
72355944|NCT04755816|144228928|OTHER|Estimates and confidence intervals are provided|Slope|-15.37|||||TWO_SIDED|95.0|-37.5|6.76|||||"The total score for the MLHFQ ranges from 0 to 105, with higher scores indicating more significant impairment in health-related quality of life. The change in MLHFQ is defined as MLHFQ at Week 12 minus MLHFQ at Week 0."|Dietary Sodium Intervention includes those in treatment group B and D. No Dietary Sodium Intervention includes those in treatment group A and C. Simple linear regression models will be used to assess the outcome of change in MLHFQ over 12 weeks as a function of treatment group assignment. Beta coefficients and 95% confidence intervals will be reported.||6.76|-37.5|
72355945|NCT04755816|144228929|OTHER|Estimates and confidence intervals are provided|Hazard Ratio (HR)|0.556|||||TWO_SIDED|95.0|0.163|1.901||||||Clinical Worsening Intervention includes those in treatment group C and D. No Clinical Worsening Intervention includes those in treatment group A and B.||1.901|0.163|
72355946|NCT04755816|144228930|OTHER|Estimates and confidence intervals are provided|Slope|-12.98|||||TWO_SIDED|95.0|-33.67|7.72|||||"The total score for the MLHFQ ranges from 0 to 105, with higher scores indicating more significant impairment in health-related quality of life. The change in MLHFQ is defined as MLHFQ at Week 12 minus MLHFQ at Week 0."|Clinical Worsening Intervention includes those in treatment group C and D. No Clinical Worsening Intervention includes those in treatment group A and B. Simple linear regression models will be used to assess the outcome of change in MLHFQ over 12 weeks as a function of treatment group assignment. Beta coefficients and 95% confidence intervals will be reported.||7.72|-33.67|
72355947|NCT02792231|144228931|SUPERIORITY||rate ratio|0.416|||<|0.001|TWO_SIDED|95.0|0.309|0.56|||negative binomial regression model|||Obtained from fitting a negative binomial regression model with log-link to the number of relapses, adjusted for treatment and region as factors, number of relapses in previous year, baseline EDSS, baseline number of Gd-enhancing lesions and the patient's age at baseline as covariates. The natural log of the time-in-study was used as offset to annualize the relapse rate.||0.560|0.309|<0.001
72355948|NCT02792231|144228932|SUPERIORITY||Hazard Ratio (HR)|0.657||||0.003|TWO_SIDED|95.0|0.5|0.863|||Regression, Cox|||Pooled data - this study was not powered for the analysis of this endpoint individually. It was pre-specified in the study protocol to combine the data from this study with study COMB157G2301 to address this endpoint.||0.863|0.500|0.003
72355949|NCT02792231|144228933|SUPERIORITY||Hazard Ratio (HR)|0.662||||0.038|TWO_SIDED|95.0|0.449|0.977|||Regression, Cox|||This study was not powered for the analysis of this endpoint individually. It was pre-specified in the study protocol to combine the data from this study with study COMB157G2301 to address this endpoint.||0.977|0.449|0.038
72355950|NCT02792231|144228934|SUPERIORITY||Hazard Ratio (HR)|0.676||||0.012|TWO_SIDED|95.0|0.498|0.917|||Regression, Cox|||This study was not powered for the analysis of this endpoint individually. It was pre-specified in the study protocol to combine the data from this study with study COMB157G2301 to address this endpoint.||0.917|0.498|0.012
72355951|NCT02792231|144228935|SUPERIORITY||Hazard Ratio (HR)|0.759||||0.215|TWO_SIDED|95.0|0.49|1.174|||Regression, Cox|||This study was not powered for the analysis of this endpoint individually. It was pre-specified in the study protocol to combine the data from this study with study COMB157G2301 to address this endpoint.||1.174|0.490|0.215
72355952|NCT02792231|144228936|SUPERIORITY||Hazard Ratio (HR)|1.355||||0.092|TWO_SIDED|95.0|0.952|1.928|||Regression, Cox|||This study was not powered for the analysis of this endpoint individually. It was pre-specified in the study protocol to combine the data from this study with study COMB157G2301 to address this endpoint.||1.928|0.952|0.092
72355953|NCT02792231|144228937|SUPERIORITY||Hazard Ratio (HR)|1.523||||0.09|TWO_SIDED|95.0|0.936|2.477|||Regression, Cox|||This study was not powered for the analysis of this endpoint individually. It was pre-specified in the study protocol to combine the data from this study with study COMB157G2301 to address this endpoint.||2.477|0.936|0.090
72355954|NCT02792231|144228938|SUPERIORITY||rate ratio|0.061|||<|0.001|TWO_SIDED|95.0|0.037|0.101|||negative binomial regression model|||||0.101|0.037|<.001
72355955|NCT02792231|144228939|SUPERIORITY||rate ratio|0.21|||<|0.001|TWO_SIDED|95.0|0.17|0.27|||negative binomial regression model|||Month 12||0.27|0.17|<.001
72355956|NCT02792231|144228939|SUPERIORITY||rate ratio|0.19|||<|0.001|TWO_SIDED|95.0|0.12|0.31|||negative binomial regression model|||Month 24||0.31|0.12|<.001
72355957|NCT02792231|144228939|SUPERIORITY||rate ratio|0.15|||<|0.001|TWO_SIDED|95.0|0.13|0.19|||negative binomial regression model|||End of Study||0.19|0.13|<.001
72355958|NCT02792231|144228940|SUPERIORITY||Geo-mean ratio|0.89|||<|0.001|TWO_SIDED|95.0|0.85|0.93|||Mixed Models Analysis|Mixed Models for Repeated Measures (MMRM)||Month 3||0.93|0.85|<.001
72355959|NCT02792231|144228940|SUPERIORITY||Geo-mean ratio|0.74|||<|0.001|TWO_SIDED|95.0|0.7|0.79|||Mixed Models Analysis|Mixed Models for Repeated Measures (MMRM)||Month 12||0.79|0.70|<.001
72355960|NCT02792231|144228940|SUPERIORITY||Geo-mean ratio|0.76|||<|0.001|TWO_SIDED|95.0|0.71|0.81|||Mixed Models Analysis|Mixed Models for Repeated Measures (MMRM)||Month 24||0.81|0.71|<.001
72355961|NCT02792231|144228941|SUPERIORITY||Mean Difference (Net)|0.07||||0.128|TWO_SIDED|95.0|-0.02|0.15|||random coefficient model|||||0.15|-0.02|0.128
72355962|NCT02792231|144228944|SUPERIORITY||Hazard Ratio (HR)|0.641||||0.002|TWO_SIDED|95.0|0.486|0.847|||Regression, Cox|||This study was not powered for the analysis of this endpoint individually. It was pre-specified in the study protocol to combine the data from this study with study COMB157G2301 to address this endpoint.||0.847|0.486|0.002
72355963|NCT02792231|144228945|SUPERIORITY||Hazard Ratio (HR)|0.657||||0.008|TWO_SIDED|95.0|0.481|0.898|||Regression, Cox|||This study was not powered for the analysis of this endpoint individually. It was pre-specified in the study protocol to combine the data from this study with study COMB157G2301 to address this endpoint.||0.898|0.481|0.008
72355964|NCT04073186|144228969|SUPERIORITY|The superiority of the First wearing Cycle was concluded if the lower confidence limit of leastsquare mean as greater than 32.|Least-square Mean|59.3|STANDARD_ERROR_OF_MEAN|2.37|||TWO_SIDED|95.0|54.6|64.0|||Linear Mixed Model|the Kenward and Roger method was used for the denominator degrees of freedom.||||64.0|54.6|
72355965|NCT04073186|144228970|SUPERIORITY|The superiority of the Test lens was concluded if the upper confidence limit of least-square mean was below the pre-defined threshold 0.10 logMAR.|Least-square Mean|-0.084|STANDARD_ERROR_OF_MEAN|0.0191|||TWO_SIDED|95.0|-0.124|-0.044||Distance (4 Meter)|Linear Mixed Model|The Kenward and Roger Method was used for the demoninator degrees of freedom.||||-0.044|-0.124|
72355966|NCT04073186|144228970|SUPERIORITY|The superiority of the Test lens was concluded if the upper confidence limit of least-square mean was below the pre-defined threshold 0.17 logMAR.|Least-square Mean|-0.028|STANDARD_ERROR_OF_MEAN|0.0191|||TWO_SIDED|95.0|-0.068|0.012|||Linear Mixed Model|The Kenward and Roger Method was used for the demoninator degrees of freedom||Intermediate (64 CM)||0.012|-0.068|
72355967|NCT04073186|144228970|SUPERIORITY|The superiority of the Test lens was concluded if the upper confidence limit of least-square mean was below the pre-defined threshold 0.17 logMAR|Least-square Means|0.037|STANDARD_ERROR_OF_MEAN|0.0191|||TWO_SIDED|95.0|-0.003|0.077|||Linear Mixed Model|The Kenward and Roger Method was used for the demoninator degrees of freedom||Near (40 CM)||0.077|-0.003|
72355968|NCT04073186|144228971|SUPERIORITY|The superiority of the Test lens at 4-week followup compared to it at 2-week follow-up will beconcluded if the lower confidence limit of leastsquare mean difference is greater than 0.|Least-square Mean Difference|-4.1|STANDARD_ERROR_OF_MEAN|2.03|||TWO_SIDED|95.0|-8.1|-0.1|||Linear Mixed Model|the Kenward and Roger method was used for the denominator degrees of freedom.|LSM difference was calculated as Second Wearing Cycle minus First Wearing Cycle|||-0.1|-8.1|
72355969|NCT00558246|144229064|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence is demonstrated if the upper limit of the 95% confidence interval (when subtracting the percentage of DERMABOND PROTAPE successful subjects from the percentage of INTRADERMAL SUTURE successful subjects) does not exceed 12%.|Differences in proportion of successes|0.0||||1|TWO_SIDED|95.0|-5.9|5.9|||McNemar||The level of significance for statistical testing was 0.05 for this study.|||5.9|-5.9|1.0000
72355970|NCT00558246|144229065|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
72355971|NCT00558246|144229066|SUPERIORITY_OR_OTHER|||||||1||95.0|||||McNemar|||||||1.0000
72355972|NCT00558246|144229067|SUPERIORITY_OR_OTHER|||||||0.2266|||||||McNemar|||||||0.2266
72355973|NCT00558246|144229068|SUPERIORITY_OR_OTHER|||||||0.5078||0.0|||||McNemar|||||||0.5078
72355974|NCT04244253|144229073|SUPERIORITY||Difference of score|-1.1||||0.288|TWO_SIDED|95.0|-3.3|1.0|||Mixed-model repeated measures|MMRM included treatment, visit, treatment-by-visit interaction, baseline, and baseline-by-visit interaction using an unstructured covariance matrix.||The statistical analysis was performed at Week 6 to compare the OPC-64005 20-mg group and placebo group.||1.0|-3.3|0.288
72355975|NCT04244253|144229074|OTHER||Difference in response rate|5.6||||0.329|TWO_SIDED|95.0|-5.6|16.8|||χ2 test|The MADRS response rate in the OPC-64005 20-mg group and the placebo group were compared using the χ2 test in the LOCF dataset.||The statistical analysis was performed at Week 6 to compare the OPC-64005 20-mg group and placebo group.||16.8|-5.6|0.329
72355976|NCT04244253|144229075|OTHER||Difference of Proportion|1.5||||0.731|TWO_SIDED|95.0|-7.2|10.3|||χ2 test|The MADRS remission rate in the OPC-64005 20-mg group and placebo group were compared using the χ2 test in the LOCF dataset.||The statistical analysis was performed at Week 6 to compare the OPC-64005 20-mg group and placebo group.||10.3|-7.2|0.731
72355977|NCT04663321|144229076|SUPERIORITY|Difference in LS Means|LS Mean Difference|3.3||||0.168|TWO_SIDED|95.0|-1.4|8.0|||ANCOVA|||||8.0|-1.4|0.168
72355978|NCT04663321|144229076|SUPERIORITY|Difference in LS Means|LS Mean Difference|-1.1||||0.697|TWO_SIDED|95.0|-6.9|4.7|||ANCOVA|||||4.7|-6.9|0.697
72355979|NCT04663321|144229077|SUPERIORITY|Difference in LS Means|LS Mean Difference|2.9||||0.124|TWO_SIDED|95.0|-0.8|6.6|||ANCOVA|||||6.6|-0.8|0.124
72355980|NCT04663321|144229077|SUPERIORITY|Difference in LS Means|LS Mean Difference|1.9||||0.417|TWO_SIDED|95.0|-2.7|6.4|||ANCOVA|||||6.4|-2.7|0.417
72355981|NCT04663321|144229080|SUPERIORITY|Difference in LS Means|LS Mean Difference|2.0||||0.187|TWO_SIDED|95.0|-1.0|5.1|||ANCOVA|||||5.1|-1.0|0.187
72355982|NCT04663321|144229080|SUPERIORITY|Difference in LS Means|LS Mean Difference|-0.6||||0.738|TWO_SIDED|95.0|-4.3|3.1|||ANCOVA|||||3.1|-4.3|0.738
72355983|NCT04663321|144229081|SUPERIORITY|Difference in LS means|LS Mean Difference|1.7||||0.182|TWO_SIDED|95.0|-0.8|4.3|||ANCOVA|||||4.3|-0.8|0.182
72355984|NCT04663321|144229082|SUPERIORITY|Difference in LS Means|LS Mean Difference|0.1||||0.63|TWO_SIDED|95.0|-0.4|0.7|||ANCOVA|||||0.7|-0.4|0.630
72355985|NCT04663321|144229082|SUPERIORITY|Difference in LS Means|LS Mean Difference|-0.2||||0.549|TWO_SIDED|95.0|-0.9|0.5|||ANCOVA|||||0.5|-0.9|0.549
72355986|NCT04663321|144229083|SUPERIORITY|Difference in LS Means|LS Mean Difference|0.4||||0.062|TWO_SIDED|95.0|0.0|0.8|||ANCOVA|||||0.8|-0.0|0.062
72355987|NCT04663321|144229083|SUPERIORITY|Difference in LS Means|LS Mean Difference|0.0||||0.878|TWO_SIDED|95.0|-0.5|0.5|||ANCOVA|||||0.5|-0.5|0.878
72355988|NCT02795117|144229089|EQUIVALENCE|provides 85% power of success|equivalence ratio|96.4|||||TWO_SIDED|90.0|91.0|105.4||No p-value was calculated for bioequivalence, only a T/R ratio and 90% confidence interval|ANOVA|||||105.4|91.0|
72355989|NCT02795117|144229090|EQUIVALENCE|provides 85% power of success|Equivalence difference|-6.48|||||TWO_SIDED|90.0|-18.31|1.85|||Wald's method|||||1.85|-18.31|
72355990|NCT02653326|144229091|SUPERIORITY|||||||0.63|||||||t-test, 2 sided|||||||0.63
72355991|NCT02653326|144229092|SUPERIORITY|||||||0.32|||||||t-test, 2 sided|||||||0.32
72355992|NCT04621448|144229141|SUPERIORITY||Mean Difference (Final Values)|2.2||||0.048|TWO_SIDED|95.0|0.01|4.39|||Mixed Models Analysis||The mean difference estimate of 2.2 was confirmed. It is slightly different than the difference of the raw change values \[+.7 - (-1.7) = 2.4\] because it comes from the mixed effects model.|||4.39|0.01|0.048
72355993|NCT04621448|144229142|SUPERIORITY||Mean Difference (Final Values)|-0.9||||0.603|TWO_SIDED|95.0|-4.12|2.4|||Mixed Models Analysis|||||2.40|-4.12|0.603
72355994|NCT04621448|144229143|SUPERIORITY||Mean Difference (Final Values)|0.6||||0.734|TWO_SIDED|95.0|-2.75|3.92|||Mixed Models Analysis|||||3.92|-2.75|0.734
72355995|NCT04621448|144229144|SUPERIORITY||Mean Difference (Final Values)|1.6||||0.159|TWO_SIDED|95.0|-0.62|3.74|||Mixed Models Analysis|||||3.74|-0.62|0.159
72355996|NCT04621448|144229145|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.818|TWO_SIDED|95.0|-1.97|1.56|||Mixed Models Analysis|||||1.56|-1.97|0.818
72355997|NCT04621448|144229146|SUPERIORITY||Mean Difference (Final Values)|1.6||||0.089|TWO_SIDED|95.0|-0.26|3.51|||Mixed Models Analysis|||||3.51|-0.26|0.089
72355998|NCT04621448|144229147|SUPERIORITY||Mean Difference (Final Values)|0.3||||0.631|TWO_SIDED|95.0|-0.96|1.58|||Mixed Models Analysis|||||1.58|-0.96|0.631
72355999|NCT04621448|144229148|SUPERIORITY||Mean Difference (Final Values)|0.4||||0.484|TWO_SIDED|95.0|-0.71|1.49|||Mixed Models Analysis|||||1.49|-0.71|0.484
72356000|NCT04621448|144229149|SUPERIORITY||Mean Difference (Final Values)|0.3||||0.81|TWO_SIDED|95.0|-2.36|3.01|||Mixed Models Analysis|||||3.01|-2.36|0.81
72356001|NCT04621448|144229150|SUPERIORITY||Mean Difference (Final Values)|0.6||||0.384|TWO_SIDED|95.0|-0.77|2.0|||Mixed Models Analysis|||||2.00|-0.77|0.384
72356002|NCT04621448|144229151|SUPERIORITY||Mean Difference (Final Values)|-0.4||||0.509|TWO_SIDED|95.0|-1.65|0.81|||Mixed Models Analysis|||||0.81|-1.65|0.509
72356003|NCT04621448|144229152|SUPERIORITY||Mean Difference (Final Values)|1.6||||0.021|TWO_SIDED|95.0|0.24|3.01|||Mixed Models Analysis|||||3.01|0.24|0.021
72356004|NCT04621448|144229153|SUPERIORITY||Mean Difference (Final Values)|-0.8||||0.156|TWO_SIDED|95.0|-1.94|0.31|||Mixed Models Analysis|||||0.31|-1.94|0.156
72356005|NCT04621448|144229154|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.582|TWO_SIDED|95.0|-0.62|1.1|||Mixed Models Analysis|||||1.10|-0.62|0.582
72356006|NCT04621448|144229155|SUPERIORITY||Mean Difference (Final Values)|-0.4||||0.271|TWO_SIDED|95.0|-1.21|0.34|||Mixed Models Analysis|||||0.34|-1.21|0.271
72356007|NCT04621448|144229156|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.834|TWO_SIDED|95.0|-1.52|1.88|||Mixed Models Analysis|||||1.88|-1.52|0.834
72356008|NCT04621448|144229157|SUPERIORITY||Mean Difference (Final Values)|0.8||||0.529|TWO_SIDED|95.0|-1.62|3.15|||Mixed Models Analysis|||||3.15|-1.62|0.529
72356009|NCT04621448|144229158|SUPERIORITY|||||||0.377|||||||Poisson regression|||||||0.377
72356010|NCT04621448|144229159|SUPERIORITY|||||||0.043|||||||Poisson regression|||||||0.043
72356011|NCT03550378|144229160|SUPERIORITY||LS Mean Difference|-30.384|||<|0.001|TWO_SIDED|90.0|-41.27|-19.498|||ANCOVA|||||-19.498|-41.270|<0.001
72356012|NCT01300234|144229222|SUPERIORITY_OR_OTHER||percentage of participants|58.5|||<|0.0001|TWO_SIDED|97.5|45.8|71.3||HBeAg-positive participants|Roche COBAS Taqman HBV test||"A non-completers equal failures approach is used for the primary analysis. The estimated value represents the difference between the percentage of participants achieving HBV DNA \<400 copies/mL at Week 48 in the TDF group and the ADV group."|||71.3|45.8|<0.0001
72356013|NCT01300234|144229222|SUPERIORITY_OR_OTHER||percentage of participants|25.6|||<|0.0001|TWO_SIDED|97.5|16.7|34.3||HBeAg-negative participants|Roche COBAS Taqman HBV test||"A non-completers equal failures approach was used for the primary analysis. The estimated value represents the difference between the percentage of participants achieving HBV DNA \<400 copies/mL at Week 48 in the TDF group and the ADV group."|||34.3|16.7|<0.0001
72356014|NCT00550407|144229278|SUPERIORITY_OR_OTHER|||||||0.01||95.0|||||Log Rank|||||||0.010
72356015|NCT05051579|144229296|SUPERIORITY||LS Mean difference (Final Values)|-6.5|||<|0.001|TWO_SIDED|95.0|-8.9|-4.2|||Mixed Models Analysis|||||-4.2|-8.9|<0.001
72356016|NCT05051579|144229296|SUPERIORITY||LS Mean difference (Final Values)|-9.2|||<|0.001|TWO_SIDED|95.0|-11.5|-6.9|||Mixed Models Analysis|||||-6.9|-11.5|<0.001
72356017|NCT05051579|144229296|SUPERIORITY||LS Mean difference (Final Values)|-10.2|||<|0.001|TWO_SIDED|95.0|-12.4|-8.0|||Mixed Models Analysis|||||-8.0|-12.4|<0.001
72356018|NCT05051579|144229296|SUPERIORITY||LS Mean difference (Final Values)|-10.6|||<|0.001|TWO_SIDED|95.0|-12.7|-8.4|||Mixed Models Analysis|||||-8.4|-12.7|<0.001
72356019|NCT05051579|144229297|OTHER||LS Mean difference (Final Values)|-7.1|||<|0.001|TWO_SIDED|95.0|-9.9|-4.2|||Mixed Models Analysis|||||-4.2|-9.9|<0.001
72356020|NCT05051579|144229297|OTHER||LS Mean difference (Final Values)|-10.1|||<|0.001|TWO_SIDED|95.0|-12.9|-7.3|||Mixed Models Analysis|||||-7.3|-12.9|<0.001
72356021|NCT05051579|144229297|OTHER||LS Mean difference (Final Values)|-11.1|||<|0.001|TWO_SIDED|95.0|-13.8|-8.4|||Mixed Models Analysis|||||-8.4|-13.8|<0.001
72356022|NCT05051579|144229297|OTHER||LS Mean difference (Final Values)|-12.3|||<|0.001|TWO_SIDED|95.0|-15.0|-9.6|||Mixed Models Analysis|||||-9.6|-15.0|<0.001
72356023|NCT05051579|144229298|OTHER||LS Mean difference (Final Values)|-6.9|||<|0.001|TWO_SIDED|95.0|-9.3|-4.4|||Mixed Models Analysis|||||-4.4|-9.3|<0.001
72356024|NCT05051579|144229298|OTHER||LS Mean difference (Final Values)|-10.2|||<|0.001|TWO_SIDED|95.0|-12.5|-7.8|||Mixed Models Analysis|||||-7.8|-12.5|<0.001
72356025|NCT05051579|144229298|OTHER||LS Mean difference (Final Values)|-10.8|||<|0.001|TWO_SIDED|95.0|-13.1|-8.5|||Mixed Models Analysis|||||-8.5|-13.1|<0.001
72356026|NCT05051579|144229298|OTHER||LS Mean difference (Final Values)|-11.2|||<|0.001|TWO_SIDED|95.0|-13.5|-8.9|||Mixed Models Analysis|||||-8.9|-13.5|<0.001
72356027|NCT05051579|144229299|OTHER||LS Mean difference (Final Values)|-7.4|||<|0.001|TWO_SIDED|95.0|-10.4|-4.3|||Mixed Models Analysis|||||-4.3|-10.4|<0.001
72356028|NCT05051579|144229299|OTHER||LS Mean difference (Final Values)|-11.2|||<|0.001|TWO_SIDED|95.0|-14.2|-8.3|||Mixed Models Analysis|||||-8.3|-14.2|<0.001
72356029|NCT05051579|144229299|OTHER||LS Mean difference (Final Values)|-11.8|||<|0.001|TWO_SIDED|95.0|-14.7|-9.0|||Mixed Models Analysis|||||-9.0|-14.7|<0.001
72356030|NCT05051579|144229299|OTHER||LS Mean difference (Final Values)|-13.0|||<|0.001|TWO_SIDED|95.0|-15.8|-10.2|||Mixed Models Analysis|||||-10.2|-15.8|<0.001
72356031|NCT05051579|144229300|OTHER||LS Mean difference (Final Values)|-4.4||||0.002|TWO_SIDED|95.0|-7.2|-1.6|||Mixed Models Analysis|||||-1.6|-7.2|0.002
72356032|NCT05051579|144229300|OTHER||LS Mean difference (Final Values)|-5.2|||<|0.001|TWO_SIDED|95.0|-8.0|-2.4|||Mixed Models Analysis|||||-2.4|-8.0|<0.001
72356033|NCT05051579|144229300|OTHER||LS Mean difference (Final Values)|-6.5|||<|0.001|TWO_SIDED|95.0|-9.2|-3.8|||Mixed Models Analysis|||||-3.8|-9.2|<0.001
72356034|NCT05051579|144229300|OTHER||LS Mean difference (Final Values)|-8.7|||<|0.001|TWO_SIDED|95.0|-11.3|-6.0|||Mixed Models Analysis|||||-6.0|-11.3|<0.001
72356035|NCT05051579|144229301|OTHER||LS Mean difference (Final Values)|-5.6|||<|0.001|TWO_SIDED|95.0|-8.8|-2.4|||Mixed Models Analysis|||||-2.4|-8.8|<0.001
72356036|NCT05051579|144229301|OTHER||LS Mean difference (Final Values)|-7.2|||<|0.001|TWO_SIDED|95.0|-10.3|-4.0|||Mixed Models Analysis|||||-4.0|-10.3|<0.001
72356037|NCT05051579|144229301|OTHER||LS Mean difference (Final Values)|-6.6|||<|0.001|TWO_SIDED|95.0|-9.7|-3.6|||Mixed Models Analysis|||||-3.6|-9.7|<0.001
72356038|NCT05051579|144229301|OTHER||LS Mean difference (Final Values)|-9.6|||<|0.001|TWO_SIDED|95.0|-12.7|-6.6|||Mixed Models Analysis|||||-6.6|-12.7|<0.001
72356039|NCT05051579|144229302|OTHER||LS Mean difference (Final Values)|-2.4|||<|0.001|TWO_SIDED|95.0|-3.2|-1.6|||Mixed Models Analysis|||||-1.6|-3.2|<0.001
72356040|NCT05051579|144229302|OTHER||LS Mean difference (Final Values)|-3.5|||<|0.001|TWO_SIDED|95.0|-4.3|-2.6|||Mixed Models Analysis|||||-2.6|-4.3|<0.001
72356041|NCT05051579|144229302|OTHER||LS Mean difference (Final Values)|-3.8|||<|0.001|TWO_SIDED|95.0|-4.6|3.0|||Mixed Models Analysis|||||3.0|-4.6|<0.001
72356042|NCT05051579|144229302|OTHER||LS Mean difference (Final Values)|-3.9|||<|0.001|TWO_SIDED|95.0|-4.7|-3.1|||Mixed Models Analysis|||||-3.1|-4.7|<0.001
72356043|NCT05051579|144229303|OTHER||LS Mean difference (Final Values)|-2.5|||<|0.001|TWO_SIDED|95.0|-3.6|-1.5|||Mixed Models Analysis|||||-1.5|-3.6|<0.001
72356044|NCT05051579|144229303|OTHER||LS Mean difference (Final Values)|-3.8|||<|0.001|TWO_SIDED|95.0|-4.8|-2.8|||Mixed Models Analysis|||||-2.8|-4.8|<0.001
72356045|NCT05051579|144229303|OTHER||LS Mean difference (Final Values)|-4.2|||<|0.001|TWO_SIDED|95.0|-5.2|-3.2|||Mixed Models Analysis|||||-3.2|-5.2|<0.001
72356046|NCT05051579|144229303|OTHER||LS Mean difference (Final Values)|-4.6|||<|0.001|TWO_SIDED|95.0|-5.6|-3.6|||Mixed Models Analysis|||||-3.6|-5.6|<0.001
72356047|NCT05051579|144229304|OTHER||Odds Ratio (OR)|9.96|||<|0.001|TWO_SIDED|95.0|3.61|27.44|||Regression, Logistic|||||27.44|3.61|<0.001
72356048|NCT05051579|144229304|OTHER||Odds Ratio (OR)|27.97|||<|0.001|TWO_SIDED|95.0|8.15|96.01|||Regression, Logistic|||||96.01|8.15|<0.001
72356049|NCT05051579|144229304|OTHER||Odds Ratio (OR)|27.36|||<|0.001|TWO_SIDED|95.0|8.71|85.91|||Regression, Logistic|||||85.91|8.71|<0.001
72356050|NCT05051579|144229304|OTHER||Odds Ratio (OR)|23.59|||<|0.001|TWO_SIDED|95.0|7.65|72.77|||Regression, Logistic|||||72.77|7.65|<0.001
72356051|NCT05051579|144229305|OTHER||Odds Ratio (OR)|19.93|||<|0.001|TWO_SIDED|95.0|3.47|114.4|||Regression, Logistic|||||114.40|3.47|<0.001
72356052|NCT05051579|144229305|OTHER||Odds Ratio (OR)|39.52|||<|0.001|TWO_SIDED|95.0|6.95|224.83|||Regression, Logistic|||||224.83|6.95|<0.001
72356053|NCT05051579|144229305|OTHER||Odds Ratio (OR)|74.97|||<|0.001|TWO_SIDED|95.0|13.16|427.18|||Regression, Logistic|||||427.18|13.16|<0.001
72356054|NCT05051579|144229305|OTHER||Odds Ratio (OR)|72.23|||<|0.001|TWO_SIDED|95.0|12.62|413.21|||Regression, Logistic|||||413.21|12.62|<0.001
72356055|NCT05051579|144229306|OTHER||Odds Ratio (OR)|7.79|||<|0.001|TWO_SIDED|95.0|2.9|20.92|||Regression, Logistic|||||20.92|2.90|<0.001
72356056|NCT05051579|144229306|OTHER||Odds Ratio (OR)|25.07|||<|0.001|TWO_SIDED|95.0|7.49|83.91|||Regression, Logistic|||||83.91|7.49|<0.001
72356057|NCT05051579|144229306|OTHER||Odds Ratio (OR)|34.76|||<|0.001|TWO_SIDED|95.0|8.17|147.86|||Regression, Logistic|||||147.86|8.17|<0.001
72356058|NCT05051579|144229306|OTHER||Odds Ratio (OR)|28.01|||<|0.001|TWO_SIDED|95.0|8.15|96.29|||Regression, Logistic|||||96.29|8.15|<0.001
72356059|NCT05051579|144229307|OTHER||Odds Ratio (OR)|8.27|||<|0.001|TWO_SIDED|95.0|2.59|26.45|||Regression, Logistic|||||26.45|2.59|<0.001
72356060|NCT05051579|144229307|OTHER||Odds Ratio (OR)|15.64|||<|0.001|TWO_SIDED|95.0|4.83|50.68|||Regression, Logistic|||||50.68|4.83|<0.001
72356061|NCT05051579|144229307|OTHER||Odds Ratio (OR)|27.24|||<|0.001|TWO_SIDED|95.0|8.39|88.38|||Regression, Logistic|||||88.38|8.39|<0.001
72356062|NCT05051579|144229307|OTHER||Odds Ratio (OR)|20.88|||<|0.001|TWO_SIDED|95.0|6.59|66.17|||Regression, Logistic|||||66.17|6.59|<0.001
72356063|NCT03062358|144229365|SUPERIORITY||Hazard Ratio (HR)|0.79||||0.018|TWO_SIDED|95.0|0.63|0.99||Log-rank test|One-sided p-value|Stratified by macrovascular invasion, α-Fetoprotein and region with all cells that correspond to macrovascular invasion=Yes combined|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate||Stratified by macrovascular invasion (Yes vs. No), α-Fetoprotein (ng/mL) (\< 200 vs. ≥ 200) and region (China vs. ex-China) with all cells that correspond to macrovascular invasion=Yes combined.|0.99|0.63|0.0180
72356064|NCT03062358|144229366|SUPERIORITY||Hazard Ratio (HR)|0.74||||0.0032|TWO_SIDED|95.0|0.6|0.92||Log-rank test|One-sided p-value|Stratified by macrovascular invasion, α-Fetoprotein and region with all cells that correspond to macrovascular invasion=Yes combined|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate||Stratified by macrovascular invasion (Yes vs. No), α-Fetoprotein (ng/mL) (\< 200 vs. ≥ 200) and region (China vs. ex-China) with all cells that correspond to macrovascular invasion=Yes combined.|0.92|0.60|0.0032
72356065|NCT03062358|144229367|OTHER||Percent Difference|11.4||||4e-05|TWO_SIDED|95.0|6.7|16.0|||One-sided p-value for testing|H0: difference in % =0 versus H1: difference in % \> 0.|Difference in % vs Placebo|Difference in % vs Placebo|Based on Miettinen \& Nurminen method stratified by macrovascular invasion (Yes vs. No), α-Fetoprotein (ng/mL) (\< 200 vs. \>= 200) and region (China vs. ex-China) with all cells that correspond to macrovascular invasion=Yes combined.|16.0|6.7|0.00004
72356066|NCT03062358|144229369|OTHER||Percent Difference|5.4||||0.13281|TWO_SIDED|95.0|-4.1|14.8|||One-sided p-value for testing|H0: difference in % =0 versus H1: difference in % \> 0.|Difference in % vs Placebo|Difference in % vs Placebo|Based on Miettinen \& Nurminen method stratified by macrovascular invasion (Yes vs. No), α-Fetoprotein (ng/mL) (\< 200 vs. ≥ 200) and region (China vs. ex-China) with all cells that correspond to macrovascular invasion=Yes combined.|14.8|-4.1|0.13281
72356067|NCT03062358|144229370|OTHER||Hazard Ratio (HR)|0.72||||0.0019|TWO_SIDED|95.0|0.58|0.9||Log-rank test|One-sided p-value|Stratified by macrovascular invasion, α-Fetoprotein and region with all cells that correspond to macrovascular invasion=Yes combined|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate||Stratified by macrovascular invasion (Yes vs. No), α-Fetoprotein (ng/mL) (\< 200 vs. ≥ 200) and region (China vs. ex-China) with all cells that correspond to macrovascular invasion=Yes combined.|0.90|0.58|0.0019
72356068|NCT03861273|144229373|NON_INFERIORITY|A repeated measure negative binomial regression model was used to do the hypothesis test on non-inferiority with one-sided test.|Mean Difference (Final Values)|-3.13||||0.0081|TWO_SIDED|95.0|-5.44|-0.81|||Generalized linear model (GLM)|The treatment difference and P-value were obtained from a repeated measures GLM with negative binomial distribution and identity link function.||||-0.81|-5.44|0.0081
72356069|NCT03861273|144229374|NON_INFERIORITY|A repeated measure negative binomial regression model was used to do the hypothesis test on non-inferiority with one-sided test.|Median Difference (Final Values)|-2.62||||0.0019|TWO_SIDED|95.0|-4.27|-0.96|||Generalized linear model (GLM)|The treatment difference and P-value were obtained from a repeated measures GLM with negative binomial distribution and identity link function.||||-0.96|-4.27|0.0019
72356070|NCT03861273|144229375|SUPERIORITY||Mean Difference (Final Values)|-54.37|||<|0.0001|TWO_SIDED|95.0|-63.64|-45.1|||Paired t-test|||The treatment difference (PF-06838435 - FIX Prophylaxis) estimate (95% CI) and p-value were obtained from paired t-test.||-45.10|-63.64|<.0001
72356071|NCT03861273|144229376|OTHER||||||<|0.0001||||||P-value from one-sided t-statistic testing the log transformation of the steady state FIX:C \> log(5). Cumulative for 3 assays.|One-sided t-statistic testing|||Week 12 to Month 15||||<.0001
72356072|NCT03861273|144229378|SUPERIORITY||Mean Difference (Final Values)|-2935.7|||<|0.0001|TWO_SIDED|95.0|-3403.1|-2468.3|||Paired t-test|||||-2468.30|-3403.10|<.0001
72356073|NCT03861273|144229379|NON_INFERIORITY|The treatment difference and P-value were obtained from a repeated measures GLM with negative binomial distribution and identity link function.|Mean Difference (Final Values)|-2.55||||0.0191|TWO_SIDED|95.0|-4.67|-0.42|||Generalized linear model (GLM)|||||-0.42|-4.67|0.0191
72356074|NCT03861273|144229380|NON_INFERIORITY|The treatment difference and P-value were obtained from a repeated measures GLM with negative binomial distribution and identity link function.|Median Difference (Final Values)|-0.57||||0.1528|TWO_SIDED|95.0|-1.35|0.21|||Generalized linear model (GLM)|||||0.21|-1.35|0.1528
72356075|NCT03861273|144229381|NON_INFERIORITY|The treatment difference and P-value were obtained from a repeated measures GLM with negative binomial distribution and identity link function.|Mean Difference (Final Values)|-0.51||||0.3738|TWO_SIDED|95.0|-1.63|0.61|||Generalized linear model (GLM)|||||0.61|-1.63|0.3738
72356076|NCT03861273|144229384|OTHER|||||||0.0117|||||||Paired t-test|||||||0.0117
72356077|NCT03861273|144229385|OTHER|||||||0.0052|||||||Paired t-test|||||||0.0052
72356078|NCT03861273|144229386|OTHER|||||||0.0237|||||||Paired t-test|||||||0.0237
72356079|NCT03799341|144229400|OTHER|||||||0.177|||||||Wilcoxon (Mann-Whitney)|||||||0.177
72356080|NCT03799341|144229401|OTHER|||||||0.033|||||||Wilcoxon (Mann-Whitney)|||||||0.033
72356081|NCT03799341|144229402|OTHER|||||||0.126|||||||Wilcoxon (Mann-Whitney)|||||||0.126
72356082|NCT03799341|144229403|OTHER|||||||0.384|||||||Wilcoxon (Mann-Whitney)|||||||0.384
72356083|NCT03799341|144229404|OTHER|||||||0.308|||||||Wilcoxon (Mann-Whitney)|||||||0.308
72356084|NCT03799341|144229405|OTHER|||||||0.976|||||||Wilcoxon (Mann-Whitney)|||||||0.976
72356085|NCT03799341|144229406|OTHER|||||||0.92|||||||Wilcoxon (Mann-Whitney)|||||||0.920
72356086|NCT03799341|144229407|OTHER|||||||0.873|||||||Wilcoxon (Mann-Whitney)|||||||0.873
72356087|NCT03799341|144229408|OTHER||||||<|0.001|||||||ANOVA|||Due to violations of normality assumptions, a non-parametric Aligned Rank Transform ANOVA was conducted, which does not permit inclusion of covariates. A median split approach was therefore used to examine the influence of Contingency Management session attendance. The design included 4 factors: time (2 levels), stimulus condition (3 levels), electrode pair (4 levels), and median split group membership (2 levels). Reported results reflect the interaction between time and median split group.||||<0.001
72356088|NCT03799341|144229408|OTHER||||||<|0.001|||||||ANOVA|||Due to violations of normality assumptions, a non-parametric Aligned Rank Transform ANOVA was conducted, which does not permit covariates. A median split approach was therefore used to examine the influence of self-reported cocaine abstinence during treatment. The design included 4 factors: time (2 levels), stimulus condition (3 levels), electrode pair (4 levels), and median split group membership (2 levels). Reported results reflect the interaction between time and median split group.||||<0.001
72356089|NCT03799341|144229408|OTHER|||||||0.022|||||||ANOVA|||Due to violations of normality assumptions, a non-parametric Aligned Rank Transform ANOVA was conducted, which does not permit inclusion of covariates. A median split approach was therefore used to examine the influence of Contingency Management session attendance. The design included 4 factors: time (2 levels), response accuracy (2 levels), electrode pair (4 levels), and median split group membership (2 levels). Reported results reflect the interaction between time and median split group.||||0.022
72356090|NCT03799341|144229408|OTHER|||||||0.024|||||||ANOVA|||Due to violations of normality assumptions, a non-parametric Aligned Rank Transform ANOVA was conducted, which does not permit covariates. A median split approach was therefore used to examine the influence of self-reported cocaine abstinence during treatment. The design included 4 factors: time (2 levels), response accuracy (2 levels), electrode pair (4 levels), and median split group membership (2 levels). Reported results reflect the interaction between time and median split group.||||0.024
72356091|NCT03799341|144229409|OTHER|||||||0.973|||||||ANOVA|||No violations of normality assumptions were identified. A repeated measures ANOVA was conducted. To maintain consistency with other outcome measures, a median split approach was used to examine the potential influence of Contingency Management session attendance. The design included two factors: time (2 levels) and median split group membership (2 levels). Reported results reflect the interaction between time and median split group.||||0.973
72356092|NCT03799341|144229409|OTHER|||||||0.662|||||||ANOVA|||No violations of normality assumptions were identified. A repeated measures ANOVA was conducted. To maintain consistency with other outcome measures, a median split approach was used to examine the potential influence of self-reported cocaine abstinence during the 12-week treatment interval. The design included two factors: time (2 levels) and median split group membership (2 levels). Reported results reflect the interaction between time and median split group.||||0.662
72356093|NCT03799341|144229410|OTHER|||||||0.878|||||||ANOVA|||Due to violations of normality assumptions, a non-parametric Aligned Rank Transform ANOVA was conducted, which does not permit inclusion of covariates. A median split approach was therefore used to examine the potential influence of Contingency Management session attendance. The design included 3 factors: time (2 levels), condition (2 levels), and median split group membership (2 levels). Reported results reflect the interaction between time, condition, and median split group.||||0.878
72356094|NCT03799341|144229410|OTHER|||||||0.645|||||||ANOVA|||Due to violations of normality assumptions, a non-parametric Aligned Rank Transform ANOVA was conducted, which does not permit inclusion of covariates. A median split approach was therefore used to examine the potential influence of self-reported cocaine abstinence during treatment. The design included 3 factors: time (2 levels), condition (2 levels), and median split group membership (2 levels). Reported results reflect the interaction between time, condition, and median split group.||||0.645
72356095|NCT01116648|144229411|OTHER||Maximum Tolerated Dose (mg)|30.0|||||TWO_SIDED||||||||Cediranib|||||
72356096|NCT01116648|144229411|OTHER||Maximum Tolerated Dose (mg BID)|200.0|||||TWO_SIDED||||||||Olaparib|||||
72356097|NCT01116648|144229413|SUPERIORITY||Hazard Ratio (HR)|0.5||||0.006|TWO_SIDED|95.0|0.3|0.83|||Kaplan-Meier Plot|||||0.83|0.30|0.006
72356098|NCT01928927|144229433|SUPERIORITY||Theta statistic|0.5||||0.97|TWO_SIDED|95.0|0.26|0.73||No adjustment for multiple comparisons|Theta statistic; DeLong & Clarke-Pearson||The theta statistic estimates the probability that a randomly selected outcome from the telmisartan arm is \<= a randomly selected outcome from the control arm.|Null hypothesis: theta = 0.50||0.73|0.26|0.97
72356099|NCT01928927|144229434|SUPERIORITY||Theta statistic|0.57||||0.61|TWO_SIDED|95.0|0.31|0.83||No adjustment for multiple comparisons|Theta statistic; DeLong & Clarke-Pearson||The theta statistic estimates the probability that a randomly selected outcome from the telmisartan arm is \<= a randomly selected outcome from the control arm.|Null hypothesis: theta = 0.50||0.83|0.31|0.61
72356100|NCT02421172|144229531|SUPERIORITY_OR_OTHER_LEGACY||Posterior probablility|0.9729||||||||||||||||||
72356101|NCT00683878|144229537|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.1175||0.0007|TWO_SIDED|95.0|-0.63|-0.17||Primary endpoints were tested at alpha=0.027 applying Dunnett's adjustment|ANCOVA|||||-0.17|-0.63|0.0007
72356102|NCT00683878|144229537|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.55|STANDARD_ERROR_OF_MEAN|0.1175|<|0.0001|TWO_SIDED|95.0|-0.78|-0.31||Primary endpoints were tested at alpha=0.027 applying Dunnett's adjustment|ANCOVA|||||-0.31|-0.78|<0.0001
72356103|NCT00683878|144229538|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-51.0|STANDARD_ERROR_OF_MEAN|9.007|<|0.0001|TWO_SIDED|95.0|-68.7|-33.2||Secondary endpoints were tested following a sequential testing procedure at alpha=0.05|ANCOVA|||||-33.2|-68.7|<0.0001
72356104|NCT00683878|144229538|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-53.3|STANDARD_ERROR_OF_MEAN|9.039|<|0.0001|TWO_SIDED|95.0|-71.1|-35.6||Secondary endpoints were tested following a sequential testing procedure at alpha=0.05|ANCOVA|||||-35.6|-71.1|<0.0001
72356105|NCT00683878|144229539|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.55|STANDARD_ERROR_OF_MEAN|0.3896|<|0.0001|TWO_SIDED|95.0|-2.32|-0.79||Secondary endpoints were tested following a sequential testing procedure at alpha=0.05|ANCOVA|||||-0.79|-2.32|<0.0001
72356106|NCT00683878|144229539|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.78|STANDARD_ERROR_OF_MEAN|0.3896|<|0.0001|TWO_SIDED|95.0|-2.55|-1.02||Secondary endpoints were tested following a sequential testing procedure at alpha=0.05|ANCOVA|||||-1.02|-2.55|<0.0001
72356107|NCT00683878|144229540|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.5|STANDARD_ERROR_OF_MEAN|4.088|<|0.0001|TWO_SIDED|95.0|-27.5|-11.4||Secondary endpoints were tested following a sequential testing procedure at alpha=0.05|ANCOVA|||||-11.4|-27.5|<0.0001
72356108|NCT00683878|144229540|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-24.1|STANDARD_ERROR_OF_MEAN|4.082|<|0.0001|TWO_SIDED|95.0|-32.2|-16.1||Secondary endpoints were tested following a sequential testing procedure at alpha=0.05|ANCOVA|||||-16.1|-32.2|<0.0001
72356109|NCT00683878|144229541|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.1|STANDARD_ERROR_OF_MEAN|5.119||0.0496|TWO_SIDED|95.0|0.0|20.1||Secondary endpoints were tested following a sequential testing procedure at alpha=0.05|Modified logistic regression|||||20.1|0.0|0.0496
72356110|NCT00683878|144229541|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.4|STANDARD_ERROR_OF_MEAN|5.253||0.0018|TWO_SIDED|95.0|6.1|26.7||Secondary endpoints were tested following a sequential testing procedure at alpha=0.05|Modified logistic regression|||||26.7|6.1|0.0018
72356111|NCT00683878|144229542|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.85|STANDARD_ERROR_OF_MEAN|0.6006||0.1566|TWO_SIDED|95.0|-2.03|0.33||Secondary endpoints were tested following a sequential testing procedure at alpha=0.05|ANCOVA|||||0.33|-2.03|0.1566
72356112|NCT00683878|144229542|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.55|STANDARD_ERROR_OF_MEAN|0.5995||0.0101|TWO_SIDED|95.0|-2.73|-0.37||Secondary endpoints were tested following a sequential testing procedure at alpha=0.05|ANCOVA|||||-0.37|-2.73|0.0101
72356113|NCT00683878|144229543|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.58|STANDARD_ERROR_OF_MEAN|0.4838|||TWO_SIDED|95.0|-2.53|-0.62||Secondary endpoints were tested following a sequential testing procedure at alpha=0.05. The comparison was stopped due to the preceding test (PLACEBO + Pio vs Dapa 5MG + Pio) not statistically significant P value = 0.1566.|ANCOVA|||||-0.62|-2.53|
72356114|NCT00683878|144229543|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.9|STANDARD_ERROR_OF_MEAN|0.4688|<|0.0001|TWO_SIDED|95.0|-2.83|-0.98||Secondary endpoints were tested following a sequential testing procedure at alpha=0.05|ANCOVA|||||-0.98|-2.83|<0.0001
72356115|NCT00599872|144229549|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.418|||<|0.05|TWO_SIDED|95.0|-1.15|0.48|||ANCOVA|||||0.48|-1.15|<0.05
72356116|NCT00599872|144229550|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.36|||<|0.05|TWO_SIDED|95.0|-1.72|0.63|||ANCOVA|||||0.63|-1.72|<0.05
72356117|NCT01693029|144229558|EQUIVALENCE|"Equivalence margin (-0.5, 0.5) g/dL. Results from ANCOVA with factors treatment group and covariates mean baseline Hb and mean weekly dose during the evaluation period (Week 21-28)"|Mean Difference (Final Values)|-0.0926|||||TWO_SIDED|90.0|-0.2264|0.0413|||||||95% confidence interval for the difference is (-0.2522, 0.0670).|0.0413|-0.2264|
72356118|NCT05552027|144229604|SUPERIORITY||||||<|0.001||||||At the completion of scenario A (a full child safety seat installation), the participants using the CCS app had significantly fewer errors present compared to the control group.|Chi-squared|||||||<.001
72356119|NCT05552027|144229604|SUPERIORITY||||||<|0.01||||||At the end of scenario B (loose harness straps), participants using the CCS app had significantly fewer errors present compared to the control group.|Chi-squared|||||||<.01
72356120|NCT05552027|144229604|SUPERIORITY||||||<|0.01||||||At the end of scenario C (loose attachment at the base), like the other two scenarios, participants using the CCS app had significantly fewer errors present compared to the control group.|Chi-squared|||||||<.01
72356121|NCT00861705|144229609|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0018|||||||Chi-squared|Reported p-values are unadjusted and 1-sided||The study was designed to detect an increase in the incidence of pCR from 35% in the control arm to 55% in the experimental arm using a 1-sided chi square test of proportions. With a target sample of 362 patients and assuming a 10% dropout rate, an overall assessable sample size of 326 patients resulted in \> 95% power.||||0.0018
72356122|NCT00861705|144229610|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0089|||||||Chi-squared|Reported p-values are unadjusted and 1-sided||The study was designed to detect an increase in the incidence of pCR from 35% in the control arm to 55% in the experimental arm using a 1-sided chi square test of proportions. With a target sample of 362 patients and assuming a 10% dropout rate, an overall assessable sample size of 326 patients resulted in \> 95% power.||||0.0089
72356123|NCT00861705|144229611|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0029|||||||Chi-squared|Reported p-values are unadjusted and 1-sided||||||0.0029
72356124|NCT00861705|144229612|SUPERIORITY_OR_OTHER_LEGACY|||||||0.057|||||||Chi-squared|Reported p-values are unadjusted and 1-sided||||||0.057
72356125|NCT00861705|144229616|SUPERIORITY||Cox Proportional Hazard|1.19|||||TWO_SIDED|95.0|0.67|2.1||||||||2.10|0.67|
72356126|NCT00861705|144229616|SUPERIORITY||Cox Proportional Hazard|1.43|||||TWO_SIDED|95.0|0.82|2.47||||||||2.47|0.82|
72356127|NCT00861705|144229616|SUPERIORITY||Cox Proportional Hazard|0.82|||||TWO_SIDED|95.0|0.49|1.37||||||||1.37|0.49|
72356128|NCT00861705|144229617|SUPERIORITY||Cox Proportional Hazard|1.08|||||TWO_SIDED|95.0|0.66|1.75||||||||1.75|0.66|
72356129|NCT00861705|144229617|SUPERIORITY||Cox Proportional Hazard|1.2|||||TWO_SIDED|95.0|0.74|1.92||||||||1.92|0.74|
72356130|NCT00861705|144229617|SUPERIORITY||Cox Proportional Hazard|0.82|||||TWO_SIDED|95.0|0.49|1.37||||||||1.37|0.49|
72356131|NCT00861705|144229618|SUPERIORITY||Hazard Ratio (HR)|1.16|||||TWO_SIDED|95.0|0.66|2.03||||||||2.03|0.66|
72356132|NCT00861705|144229618|SUPERIORITY||Hazard Ratio (HR)|1.24|||||TWO_SIDED|95.0|0.72|2.16||||||||2.16|0.72|
72356133|NCT00861705|144229618|SUPERIORITY||Hazard Ratio (HR)|0.95|||||TWO_SIDED|95.0|0.53|1.7||||||||1.70|0.53|
72356134|NCT00423657|144229645|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% confidence interval (CI) for the observed difference in the primary outcome measure between ceftaroline and vancomycin plus aztreonam was calculated. Noninferiority was concluded if the lower limit of the 95%CI was higher than -10%.|Risk Difference (RD)|-0.4|||||TWO_SIDED|95.0|-5.8|5.0|||||Risk difference corresponds to Ceftaroline clinical cure rate minus Vancomycin plus Aztreonam clinical cure rate. The confidence interval was calculated using the Miettinen and Nurminen method without adjustment.|The primary objective of this study was to determine the noninferiority in clinical cure rate of ceftaroline in comparison with vancomycin plus aztreonam in adult subjects with cSSSI.||5.0|-5.8|
72356135|NCT04879628|144229700|SUPERIORITY||Rate ratio|0.21|||||TWO_SIDED|95.0|0.08|0.56||||||Negative binomial regression model adjusting for the categorical baseline GdE T1 lesion count (presence/absence) as covariate, treatment as factor, with offset equal to the log of the duration (in months) between the Week 12 MRI and previous MRI at Week 8.||0.56|0.08|
72356136|NCT04879628|144229700|SUPERIORITY||Rate ratio|0.11|||||TWO_SIDED|95.0|0.03|0.38||||||Negative binomial regression model adjusting for the categorical baseline GdE T1 lesion count (presence/absence) as covariate, treatment as factor, with offset equal to the log of the duration (in months) between the Week 12 MRI and previous MRI at Week 8.||0.38|0.03|
72356137|NCT04864249|144229742|SUPERIORITY|||||||0.54|||||||t-test, 2 sided|||||||0.54
72356138|NCT04864249|144229743|SUPERIORITY|||||||0.04|||||||t-test, 2 sided|||||||0.04
72356139|NCT04864249|144229744|SUPERIORITY|||||||0.89|||||||t-test, 2 sided|||||||0.89
72356140|NCT04864249|144229745|SUPERIORITY|||||||0.003|||||||t-test, 2 sided|||||||0.003
72356141|NCT04864249|144229746|SUPERIORITY|||||||0.15|||||||Chi-squared|||||||0.15
72356142|NCT04864249|144229747|SUPERIORITY|||||||0.84|||||||Chi-squared|||||||0.84
72356143|NCT04864249|144229748|SUPERIORITY|||||||0.51|||||||Wilcoxon (Mann-Whitney)|||||||0.51
72356144|NCT04864249|144229749|SUPERIORITY|||||||0.55|||||||Wilcoxon (Mann-Whitney)|||||||0.55
72356145|NCT04864249|144229750|SUPERIORITY|||||||0.55|||||||t-test, 2 sided|||||||0.55
72356146|NCT04864249|144229751|SUPERIORITY|||||||0.62|||||||t-test, 2 sided|||||||0.62
72356147|NCT04864249|144229752|SUPERIORITY|||||||0.19|||||||Chi-squared|||||||0.19
72356148|NCT04864249|144229753|SUPERIORITY|||||||0.66|||||||Chi-squared|||||||0.66
72356149|NCT04864249|144229754|SUPERIORITY|||||||0.22|||||||Wilcoxon (Mann-Whitney)|||||||0.22
72356150|NCT04864249|144229755|SUPERIORITY|||||||0.22|||||||Wilcoxon (Mann-Whitney)|||||||0.22
72356151|NCT04864249|144229756|SUPERIORITY|||||||0.56|||||||t-test, 2 sided|||||||0.56
72356152|NCT04864249|144229757|SUPERIORITY|||||||0.8|||||||t-test, 2 sided|||||||0.80
72356153|NCT04864249|144229758|SUPERIORITY|||||||0.48|||||||t-test, 2 sided|||||||0.48
72356154|NCT04864249|144229759|SUPERIORITY|||||||0.62|||||||Chi-squared|||||||0.62
72356155|NCT04864249|144229760|SUPERIORITY|||||||0.21|||||||Chi-squared|||||||0.21
72356156|NCT04864249|144229761|SUPERIORITY|||||||0.19|||||||Wilcoxon (Mann-Whitney)|||||||0.19
72356157|NCT04864249|144229762|SUPERIORITY|||||||0.19|||||||Wilcoxon (Mann-Whitney)|||||||0.19
72356158|NCT04864249|144229763|SUPERIORITY|||||||0.51|||||||t-test, 2 sided|||||||0.51
72356159|NCT04864249|144229764|SUPERIORITY|||||||0.38|||||||t-test, 2 sided|||||||0.38
72356160|NCT04864249|144229765|SUPERIORITY|||||||0.68|||||||t-test, 2 sided|||||||0.68
72356161|NCT04864249|144229766|SUPERIORITY|||||||0.42|||||||Wilcoxon (Mann-Whitney)|||||||0.42
72356162|NCT04864249|144229767|SUPERIORITY|||||||0.94|||||||Wilcoxon (Mann-Whitney)|||||||0.94
72356163|NCT04864249|144229768|SUPERIORITY|||||||0.68|||||||Wilcoxon (Mann-Whitney)|||||||0.68
72356164|NCT04864249|144229769|SUPERIORITY|||||||0.31|||||||Wilcoxon (Mann-Whitney)|||||||0.31
72356165|NCT04864249|144229770|SUPERIORITY|||||||0.52|||||||Wilcoxon (Mann-Whitney)|||||||0.52
72356166|NCT04864249|144229771|SUPERIORITY|||||||0.43|||||||Wilcoxon (Mann-Whitney)|||||||0.43
72356167|NCT04864249|144229772|SUPERIORITY|||||||0.07|||||||Wilcoxon (Mann-Whitney)|||||||0.07
72356168|NCT04864249|144229773|SUPERIORITY|||||||0.47|||||||Wilcoxon (Mann-Whitney)|||||||0.47
72356169|NCT04864249|144229774|SUPERIORITY|||||||0.41|||||||Wilcoxon (Mann-Whitney)|||||||0.41
72356170|NCT04864249|144229775|SUPERIORITY|||||||0.09|||||||Wilcoxon (Mann-Whitney)|||||||0.09
72356171|NCT04864249|144229776|SUPERIORITY|||||||0.12|||||||Wilcoxon (Mann-Whitney)|||||||0.12
72356172|NCT04864249|144229777|SUPERIORITY|||||||0.48|||||||Wilcoxon (Mann-Whitney)|||||||0.48
72356173|NCT03069352|144229823|SUPERIORITY||Hazard Ratio (HR)|0.749||||0.114|TWO_SIDED|95.0|0.524|1.071|||Log Rank|Log-rank test stratified by AML status (de novo, secondary) and age (18 - \< 75, ≥ 75).|The hazard ratio was estimated using the Cox proportional hazards model, stratified by AML status (de novo, secondary) and age (18 - \< 75, ≥ 75).|||1.071|0.524|0.114
72356174|NCT03069352|144229823|SUPERIORITY||Hazard Ratio (HR)|0.743||||0.103|TWO_SIDED|95.0|0.521|1.061|||Log Rank|Unstratified analysis|The hazard ratio was estimated using the Cox proportional hazards model.|||1.061|0.521|0.103
72356175|NCT03069352|144229824|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by age (18 - \< 75, ≥ 75) and AML status (de novo, secondary).||||||<0.001
72356176|NCT03069352|144229824|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||<0.001
72356177|NCT03069352|144229825|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by age (18 - \< 75, ≥ 75) and AML status (de novo, secondary).||||||<0.001
72356178|NCT03069352|144229825|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||<0.001
72356179|NCT03069352|144229826|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by age (18 - \< 75, ≥ 75) and AML status (de novo, secondary).||||||<0.001
72356180|NCT03069352|144229826|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||<0.001
72356181|NCT03069352|144229827|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by age (18 - \< 75, ≥ 75) and AML status (de novo, secondary).||||||<0.001
72356182|NCT03069352|144229827|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||<0.001
72356183|NCT03069352|144229828|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by age (18 - \< 75, ≥ 75) and AML status (de novo, secondary).||||||<0.001
72356184|NCT03069352|144229828|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||<0.001
72356185|NCT03069352|144229829|OTHER||LS Mean Difference|-4.507|STANDARD_ERROR_OF_MEAN|2.068|||TWO_SIDED|95.0|-8.6|-0.41|||||A linear mixed-effects regression model with a covariance structure including baseline score, stratification factors (age and AML status) treatment arm, visit, and treatment arm by visit interaction.|Cycle 3, Day 1||-0.41|-8.60|
72356186|NCT03069352|144229829|OTHER||LS Mean Difference|-4.923|STANDARD_ERROR_OF_MEAN|2.58|||TWO_SIDED|95.0|-10.03|0.19|||||A linear mixed-effects regression model with a covariance structure including baseline score, stratification factors (age and AML status) treatment arm, visit, and treatment arm by visit interaction.|Cycle 5 Day 1||0.19|-10.03|
72356187|NCT03069352|144229829|OTHER||LS Mean Difference|-0.807|STANDARD_ERROR_OF_MEAN|2.609|||TWO_SIDED|95.0|-5.98|4.36|||||A linear mixed-effects regression model with a covariance structure including baseline score, stratification factors (age and AML status) treatment arm, visit, and treatment arm by visit interaction.|Cycle 7 Day 1||4.36|-5.98|
72356188|NCT03069352|144229829|OTHER||LS Mean Difference|-1.648|STANDARD_ERROR_OF_MEAN|3.176|||TWO_SIDED|95.0|-7.94|4.64|||||A linear mixed-effects regression model with a covariance structure including baseline score, stratification factors (age and AML status) treatment arm, visit, and treatment arm by visit interaction.|Cycle 9 day 1||4.64|-7.94|
72356189|NCT03069352|144229829|SUPERIORITY|||||||0.126|||||||Linear Mixed Effects Regression Model|Model included AML status (de novo vs. secondary), age (18-\< 75 vs. ≥ 75), treatment arm, time, and treatment arm by time interaction as fixed factors||A linear mixed effects regression model with a variable covariance structure was fitted to the longitudinal data (considering all time points) to test for differences between treatment arms.||||0.126
72356190|NCT03069352|144229830|OTHER||LS Mean Difference|2.917|STANDARD_ERROR_OF_MEAN|4.617|||TWO_SIDED|95.0|-6.23|12.06|||||A linear mixed-effects regression model with a covariance structure including baseline score, stratification factors (age and AML status) treatment arm, visit, and treatment arm by visit interaction.|Cycle 3 Day 1||12.06|-6.23|
72356191|NCT03069352|144229830|OTHER||LS Mean Difference|13.388|STANDARD_ERROR_OF_MEAN|5.659|||TWO_SIDED|95.0|2.18|24.59|||||A linear mixed-effects regression model with a covariance structure including baseline score, stratification factors (age and AML status) treatment arm, visit, and treatment arm by visit interaction.|Cycle 5 Day 1||24.59|2.18|
72356192|NCT03069352|144229830|OTHER||LS Mean Difference|7.119|STANDARD_ERROR_OF_MEAN|6.031|||TWO_SIDED|95.0|-4.83|19.06|||||A linear mixed-effects regression model with a covariance structure including baseline score, stratification factors (age and AML status) treatment arm, visit, and treatment arm by visit interaction.|Cycle 7 Day 1||19.06|-4.83|
72356193|NCT03069352|144229830|OTHER||LS Mean Difference|6.381|STANDARD_ERROR_OF_MEAN|7.511|||TWO_SIDED|95.0|-8.49|21.26|||||A linear mixed-effects regression model with a covariance structure including baseline score, stratification factors (age and AML status) treatment arm, visit, and treatment arm by visit interaction.|Cycle 9 Day 1||21.26|-8.49|
72356194|NCT03069352|144229830|SUPERIORITY|||||||0.085|||||||Linear Mixed Effects Regression Model|Model included AML status (de novo vs. secondary), age (18-\< 75 vs. ≥ 75), treatment arm, time, and treatment arm by time interaction as fixed factors||A linear mixed effects regression model with a variable covariance structure was fitted to the longitudinal data (considering all time points) to test for differences between treatment arms.||||0.085
72356195|NCT03069352|144229831|SUPERIORITY||Hazard Ratio (HR)|0.583||||0.002|TWO_SIDED|95.0|0.416|0.817|||Log Rank|Log-rank test stratified by AML status (de novo, secondary) and age (18 - \< 75, ≥ 75).|The hazard ratio was estimated using the Cox proportional hazards model, stratified by AML status (de novo, secondary) and age (18 - \< 75, ≥ 75).|||0.817|0.416|0.002
72356196|NCT03069352|144229831|SUPERIORITY||Hazard Ratio (HR)|0.601||||0.003|TWO_SIDED|95.0|0.43|0.839|||Log Rank|Unstratified analysis|The hazard ratio was estimated using the Cox proportional hazards model.|||0.839|0.430|0.003
72356197|NCT03069352|144229832|SUPERIORITY||Treatment Difference|22.9||||0.001|TWO_SIDED|95.0|10.8|35.0|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by age (18 - \< 75, ≥ 75) and AML status (de novo, secondary).|Treatment difference = Venetoclax - Placebo|||35.0|10.8|0.001
72356198|NCT03069352|144229832|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||<0.001
72356199|NCT03069352|144229833|SUPERIORITY||Treatment Difference|15.2||||0.04|TWO_SIDED|95.0|1.4|29.0|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by age (18 - \< 75, ≥ 75) and AML status (de novo, secondary).|Treatment difference = Venetoclax - Placebo|||29.0|1.4|0.040
72356200|NCT03069352|144229833|SUPERIORITY|||||||0.039|||||||Fisher Exact|||||||0.039
72356201|NCT03069352|144229834|SUPERIORITY||Treatment Difference|22.4|||||TWO_SIDED|95.0|9.0|35.8||||||||35.8|9.0|
72356202|NCT03069352|144229835|SUPERIORITY||Slope|17.7|||||TWO_SIDED|95.0|-0.4|35.8||||||||35.8|-0.4|
72356203|NCT03069352|144229836|SUPERIORITY|||||||0.162|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by age (18 - \< 75, ≥ 75) and AML status (de novo, secondary).||||||0.162
72356204|NCT03069352|144229836|SUPERIORITY|||||||0.277|||||||Fisher Exact|||||||0.277
72356205|NCT03069352|144229837|SUPERIORITY|||||||0.162|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by age (18 - \< 75, ≥ 75) and AML status (de novo, secondary).||||||0.162
72356206|NCT03069352|144229837|SUPERIORITY|||||||0.277|||||||Fisher Exact|||||||0.277
72356207|NCT03069352|144229841|OTHER||Hazard Ratio (HR)|0.704||||0.04|TWO_SIDED|95.0|0.503|0.985|||Log Rank|Log-rank test stratified by AML status (de novo, secondary) and age (18 - \< 75, ≥ 75).|The hazard ratio was estimated using the Cox proportional hazards model, stratified by AML status (de novo, secondary) and age (18 - \< 75, ≥ 75).|||0.985|0.503|0.040
72356208|NCT03069352|144229841|OTHER||Hazard Ratio (HR)|0.717||||0.049|TWO_SIDED|95.0|0.514|1.0|||Log Rank|Unstratified analysis|The hazard ratio was estimated using the Cox proportional hazards model.|||1.000|0.514|0.049
72356209|NCT03100149|144229866|SUPERIORITY||Difference in Adjusted Means|-2.02|STANDARD_ERROR_OF_MEAN|1.71||0.2385|TWO_SIDED|80.0|-4.21|0.18|||Mixed Models Analysis|||||0.18|-4.21|0.2385
72356210|NCT03100149|144229866|SUPERIORITY||Difference in Adjusted Means|-0.62|STANDARD_ERROR_OF_MEAN|1.71||0.7169|TWO_SIDED|80.0|-2.82|1.58|||Mixed Models Analysis|||||1.58|-2.82|0.7169
72356211|NCT03100149|144229867|SUPERIORITY||Difference in Adjusted Means|-0.08|STANDARD_ERROR_OF_MEAN|0.165||0.6116|TWO_SIDED|80.0|-0.3|0.13||Nominal p-values are displayed for descriptive purposes only.|Mixed Models Analysis|||MDS-UPDRS Part IA||0.13|-0.30|0.6116
72356212|NCT03100149|144229867|SUPERIORITY||Difference in Adjusted Means|0.08|STANDARD_ERROR_OF_MEAN|0.165||0.6188|TWO_SIDED|80.0|-0.13|0.3||Nominal p-values are displayed for descriptive purposes only.|Mixed Models Analysis|||MDS-UPDRS Part IA||0.30|-0.13|0.6188
72356213|NCT03100149|144229867|SUPERIORITY||Difference in Adjusted Means|-0.04|STANDARD_ERROR_OF_MEAN|0.345||0.9062|TWO_SIDED|80.0|-0.48|0.4||Nominal p-values are displayed for descriptive purposes only.|Mixed Models Analysis|||MDS-UPDRS Part IB||0.40|-0.48|0.9062
72356214|NCT03100149|144229867|SUPERIORITY||Difference in Adjusted Means|0.02|STANDARD_ERROR_OF_MEAN|0.347||0.9621|TWO_SIDED|80.0|-0.43|0.46||Nominal p-values are displayed for descriptive purposes only.|Mixed Models Analysis|||MDS-UPDRS Part IB||0.46|-0.43|0.9621
72356215|NCT03100149|144229867|SUPERIORITY||Difference in Adjusted Means|-0.19|STANDARD_ERROR_OF_MEAN|0.411||0.651|TWO_SIDED|80.0|-0.71|0.34||Nominal p-values are displayed for descriptive purposes only.|Mixed Models Analysis|||MDS-UPDRS Part I Total||0.34|-0.71|0.6510
72356216|NCT03100149|144229867|SUPERIORITY||Difference in Adjusted Means|0.12|STANDARD_ERROR_OF_MEAN|0.413||0.7709|TWO_SIDED|80.0|-0.41|0.65||Nominal p-values are displayed for descriptive purposes only.|Mixed Models Analysis|||MDS-UPDRS Part I Total||0.65|-0.41|0.7709
72356217|NCT03100149|144229867|SUPERIORITY||Difference in Adjusted Means|0.34|STANDARD_ERROR_OF_MEAN|0.523||0.5177|TWO_SIDED|80.0|-0.33|1.01||Nominal p-values are displayed for descriptive purposes only.|Mixed Models Analysis|||MDS-UPDRS Part II Total||1.01|-0.33|0.5177
72356218|NCT03100149|144229867|SUPERIORITY||Difference in Adjusted Means|-0.06|STANDARD_ERROR_OF_MEAN|0.523||0.9095|TWO_SIDED|80.0|-0.73|0.61||Nominal p-values are displayed for descriptive purposes only.|Mixed Models Analysis|||MDS-UPDRS Part II Total||0.61|-0.73|0.9095
72356219|NCT03100149|144229867|SUPERIORITY||Difference in Adjusted Means|-1.88|STANDARD_ERROR_OF_MEAN|1.255||0.1354|TWO_SIDED|80.0|-3.49|-0.27||Nominal p-values are displayed for descriptive purposes only.|Mixed Models Analysis|||MDS-UPDRS Part III Total||-0.27|-3.49|0.1354
72356220|NCT03100149|144229867|SUPERIORITY||Difference in Adjusted Means|-1.02|STANDARD_ERROR_OF_MEAN|1.262||0.4217|TWO_SIDED|80.0|-2.64|0.61||Nominal p-values are displayed for descriptive purposes only.|Mixed Models Analysis|||MDS-UPDRS Part III Total||0.61|-2.64|0.4217
72356221|NCT03100149|144229867|SUPERIORITY||Difference in Adjusted Means|0.09|STANDARD_ERROR_OF_MEAN|0.369||0.8053|TWO_SIDED|80.0|-0.38|0.56||Nominal p-values are displayed for descriptive purposes only.|Mixed Models Analysis|||MDS-UPDRS Part III Subscore: Rigidity||0.56|-0.38|0.8053
72356222|NCT03100149|144229867|SUPERIORITY||Difference in Adjusted Means|0.25|STANDARD_ERROR_OF_MEAN|0.37||0.497|TWO_SIDED|80.0|-0.22|0.73||Nominal p-values are displayed for descriptive purposes only.|Mixed Models Analysis|||MDS-UPDRS Part III Subscore: Rigidity||0.73|-0.22|0.4970
72356223|NCT03100149|144229867|SUPERIORITY||Difference in Adjusted Means|-1.07|STANDARD_ERROR_OF_MEAN|0.779||0.1703|TWO_SIDED|80.0|-2.07|-0.07||Nominal p-values are displayed for descriptive purposes only.|Mixed Models Analysis|||MDS-UPDRS Part III Subscore: Bradykinesia||-0.07|-2.07|0.1703
72356224|NCT03100149|144229867|SUPERIORITY||Difference in Adjusted Means|-0.44|STANDARD_ERROR_OF_MEAN|0.782||0.5729|TWO_SIDED|80.0|-1.45|0.56||Nominal p-values are displayed for descriptive purposes only.|Mixed Models Analysis|||MDS-UPDRS Part III Subscore: Bradykinesia||0.56|-1.45|0.5729
72356225|NCT03100149|144229867|SUPERIORITY||Difference in Adjusted Means|-0.61|STANDARD_ERROR_OF_MEAN|0.324||0.0628|TWO_SIDED|80.0|-1.02|-0.19||Nominal p-values are displayed for descriptive purposes only.|Mixed Models Analysis|||MDS-UPDRS Part III Subscore: Resting Tremor||-0.19|-1.02|0.0628
72356226|NCT03100149|144229867|SUPERIORITY||Difference in Adjusted Means|-0.41|STANDARD_ERROR_OF_MEAN|0.325||0.2125|TWO_SIDED|80.0|-0.82|0.01||Nominal p-values are displayed for descriptive purposes only.|Mixed Models Analysis|||MDS-UPDRS Part III Subscore: Resting Tremor||0.01|-0.82|0.2125
72356227|NCT03100149|144229867|SUPERIORITY||Difference in Adjusted Means|-0.08|STANDARD_ERROR_OF_MEAN|0.108||0.4577|TWO_SIDED|80.0|-0.22|0.06||Nominal p-values are displayed for descriptive purposes only.|Mixed Models Analysis|||MDS-UPDRS Part III Subscore: Axial Symptoms||0.06|-0.22|0.4577
72356228|NCT03100149|144229867|SUPERIORITY||Difference in Adjusted Means|-0.01|STANDARD_ERROR_OF_MEAN|0.109||0.9182|TWO_SIDED|80.0|-0.15|0.13||Nominal p-values are displayed for descriptive purposes only.|Mixed Models Analysis|||MDS-UPDRS Part III Subscore: Axial Symptoms||0.13|-0.15|0.9182
72356229|NCT03100149|144229868|SUPERIORITY||LS Means Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.02||0.3582|TWO_SIDED|80.0|-0.05|0.01||Nominal p-values are displayed for descriptive purposes only.|ANCOVA|||||0.01|-0.05|0.3582
72356230|NCT03100149|144229868|SUPERIORITY||LS Means Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.02||0.1955|TWO_SIDED|80.0|-0.06|0.0||Nominal p-values are displayed for descriptive purposes only.|ANCOVA|||||0.00|-0.06|0.1955
72356231|NCT03100149|144229869|SUPERIORITY||Difference in Adjusted Means|0.22|STANDARD_ERROR_OF_MEAN|0.245||0.3611|TWO_SIDED|80.0|-0.09|0.54||Nominal p-values are displayed for descriptive purposes only.|ANCOVA|||||0.54|-0.09|0.3611
72356232|NCT03100149|144229869|SUPERIORITY||Difference in Adjusted Means|0.44|STANDARD_ERROR_OF_MEAN|0.243||0.0727|TWO_SIDED|80.0|0.13|0.75||Nominal p-values are displayed for descriptive purposes only.|ANCOVA|||||0.75|0.13|0.0727
72356233|NCT03100149|144229870|SUPERIORITY||Odds Ratio (OR)|0.77||||0.4265|TWO_SIDED|80.0|0.5|1.18||Nominal p-values are displayed for descriptive purposes only.|Regression, Logistic|||||1.18|0.50|0.4265
72356234|NCT03100149|144229870|SUPERIORITY||Odds Ratio (OR)|0.76||||0.4063|TWO_SIDED|80.0|0.49|1.16||Nominal p-values are displayed for descriptive purposes only.|Regression, Logistic|||||1.16|0.49|0.4063
72356235|NCT03100149|144229871|SUPERIORITY||Odds Ratio (OR)|0.75||||0.3847|TWO_SIDED|80.0|0.48|1.15||Nominal p-values are displayed for descriptive purposes only.|Regression, Logistic|||||1.15|0.48|0.3847
72356236|NCT03100149|144229871|SUPERIORITY||Odds Ratio (OR)|0.88||||0.7055|TWO_SIDED|80.0|0.57|1.36||Nominal p-values are displayed for descriptive purposes only.|Regression, Logistic|||||1.36|0.57|0.7055
72356237|NCT03100149|144229872|SUPERIORITY||Difference in Adjusted Means|-0.73|STANDARD_ERROR_OF_MEAN|0.888||0.4142|TWO_SIDED|80.0|-1.87|0.41||Nominal p-values are displayed for descriptive purposes only.|ANCOVA|||||0.41|-1.87|0.4142
72356238|NCT03100149|144229872|SUPERIORITY||Difference in Adjusted Means|-0.67|STANDARD_ERROR_OF_MEAN|0.885||0.4486|TWO_SIDED|80.0|-1.81|0.47||Nominal p-values are displayed for descriptive purposes only.|ANCOVA|||||0.47|-1.81|0.4486
72356239|NCT03100149|144229873|SUPERIORITY||Hazard Ratio (HR)|1.15||||0.3769|TWO_SIDED|80.0|0.94|1.42||Nominal p-values are displayed for descriptive purposes only.|Regression, Cox|||||1.42|0.94|0.3769
72356240|NCT03100149|144229873|SUPERIORITY||Hazard Ratio (HR)|1.25||||0.1658|TWO_SIDED|80.0|1.02|1.53||Nominal p-values are displayed for descriptive purposes only.|Regression, Cox|||||1.53|1.02|0.1658
72356241|NCT03100149|144229874|SUPERIORITY||Hazard Ratio (HR)|1.01||||0.9542|TWO_SIDED|80.0|0.77|1.33||Nominal p-values are displayed for descriptive purposes only.|Regression, Cox|||||1.33|0.77|0.9542
72356242|NCT03100149|144229874|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.4567|TWO_SIDED|80.0|0.63|1.13||Nominal p-values are displayed for descriptive purposes only.|Regression, Cox|||||1.13|0.63|0.4567
72356243|NCT04972162|144229885|OTHER|The rm-ANOVA model fitted for the primary analysis was run to confirm if there is a significant interaction for treatment and order. This confirmation of the absence of an interaction effect is needed to validate the pooling of the two periods of Web-App treatment and the two periods of Standard-of-Care treatment, respectively.||||||0.38||||||p\<0.05 would show that there is an interaction effect i.e. results would differ depending on the order in which the participants wore the hearing aids|ANOVA|||"Check for interaction effect for Ease of Communication Subscale (EC)~The statistical analysis method was a repeated-measures ANOVA in which:~* order is a between-subjects effect - i.e., each subject has just one order~* treatment is a within-subjects effect - i.e., each subjects has both treatments because of the cross-over design~* the interaction term treatment x order is a within-subjects effect. The rm-ANOVAs generates a nuisance p-value: that of the interaction effect."||||0.38
72356244|NCT04972162|144229885|OTHER|The rm-ANOVA model fitted for the primary analysis was run to confirm if there is a significant interaction for treatment and order. This confirmation of the absence of an interaction effect is needed to validate the pooling of the two periods of Web-App treatment and the two periods of Standard-of-Care treatment, respectively.||||||0.79||||||p\<0.05 would show that there is an interaction effect i.e. results would differ depending on the order in which the participants wore the hearing aids|ANOVA|||"Check for interaction effect for Background Noise Subscale (BN)~The statistical analysis method was a repeated-measures ANOVA in which:~* order is a between-subjects effect - i.e., each subject has just one order~* treatment is a within-subjects effect - i.e., each subjects has both treatments because of the cross-over design~* the interaction term treatment x order is a within-subjects effect. The rm-ANOVAs generates a nuisance p-value: that of the interaction effect."||||0.79
72356245|NCT04972162|144229885|OTHER|The rm-ANOVA model fitted for the primary analysis was run to confirm if there is a significant interaction for treatment and order. This confirmation of the absence of an interaction effect is needed to validate the pooling of the two periods of Web-App treatment and the two periods of Standard-of-Care treatment, respectively.||||||0.51||||||p\<0.05 would show that there is an interaction effect i.e. results would differ depending on the order in which the participants wore the hearing aids|ANOVA|||"Check for interaction effect for Reverberant Room Subscale (RV)~The statistical analysis method was a repeated-measures ANOVA in which:~* order is a between-subjects effect - i.e., each subject has just one order~* treatment is a within-subjects effect - i.e., each subjects has both treatments because of the cross-over design~* the interaction term treatment x order is a within-subjects effect. The rm-ANOVAs generates a nuisance p-value: that of the interaction effect."||||0.51
72369538|NCT01193257|144249351|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.875||||0.12085|TWO_SIDED|95.0|0.739|1.036|||Log Rank|||Hazard ratio is based on a stratified Cox's proportional hazard regression model with stratification factors region (North America, Europe and Rest of World) and brief pain inventory-short form (BPI-SF) worst pain score at screening (\[less than or equal to\] \<=4, greater than \[\>\] 4) with treatment as a factor in the model. A hazard ratio less than 1 for the treatment indicates better prevention of the death in the Orteronel arm as compared to placebo arm.||1.036|0.739|0.12085
72356246|NCT04972162|144229885|NON_INFERIORITY|Non-inferiority tests compared the subject´s perceived hearing aid benefit when the hearing aid was standard-of-care fitted compared to Web-App fitted by the subject. The non-inferiority margins are the minimum clinically important differences on each of the 3 communication benefit subscales as described by Cox \& Alexander (Ear and Hearing 1995;16;176-186). These literature values are as follows: Ease of Communication (EC): 26, Background Noise (BN): 27, Reverberant Room (RV): 28|Mean Difference (Final Values)|0.44|||<|0.0001|TWO_SIDED|95.0|-4.3|5.2||Threshold for statistical significance was p =0.05. p-value was calculated using the estimated difference of benefits, calculating a new t-statistic by subtracting the applicable non-inf. margin from the difference and dividing by standard error.|ANOVA|repeated measures ANOVA where factors are order and treatment is device with patient as a random effect. Added interaction term of treatment and order|Difference calculated as benefit(standard-of-care fit) - benefit(web-app-fit)|Results for Ease of Communication Subscale. Null hypothesis: benefit(standard-of-care fit) - benefit(web-app-fit) \< noninferiority margin for all subscales. Each subscale was analyzed using an rm-ANOVA in which the repeated factors are order \& treatment; no between-group factors. Interaction term was order x treatment. ITT population includes 2 subjects who withdrew. It was concluded that their primary endpoint data was missing for cause and their APHAB benefit scores were imputed as 0.||5.2|-4.3|<0.0001
72356247|NCT04972162|144229885|NON_INFERIORITY|Non-inferiority tests compared the subject´s perceived hearing aid benefit when the hearing aid was standard-of-care fitted compared to Web-App fitted by the subject. The non-inferiority margins are the minimum clinically important differences on each of the 3 communication benefit subscales as described by Cox \& Alexander (Ear and Hearing 1995;16;176-186). These literature values are as follows: Ease of Communication (EC): 26, Background Noise (BN): 27, Reverberant Room (RV): 28|Mean Difference (Final Values)|0.97|||<|0.0001|TWO_SIDED|95.0|-5.3|7.2||Threshold for statistical significance was p =0.05. p-value was calculated using the estimated difference of benefits, calculating a new t-statistic by subtracting the applicable non-inf. margin from the difference and dividing by standard error.|ANOVA|repeated measures ANOVA where factors are order and treatment is device with patient as a random effect. Added interaction term of treatment and order|Difference calculated as benefit(standard-of-care fit) - benefit(web-app-fit)|Results for Background Noise Subscale. Null hypothesis: benefit(standard-of-care fit) - benefit(web-app-fit) \< noninferiority margin for all subscales. Each subscale was analyzed using an rm-ANOVA in which the repeated factors are order \& treatment; no between-group factors. Interaction term was order x treatment. ITT population includes 2 subjects who withdrew. It was concluded that their primary endpoint data was missing for cause and their APHAB benefit scores were imputed as 0.||7.2|-5.3|<0.0001
72356248|NCT04972162|144229885|NON_INFERIORITY|Non-inferiority tests compared the subject´s perceived hearing aid benefit when the hearing aid was standard-of-care fitted compared to Web-App fitted by the subject. The non-inferiority margins are the minimum clinically important differences on each of the 3 communication benefit subscales as described by Cox \& Alexander (Ear and Hearing 1995;16;176-186). These literature values are as follows: Ease of Communication (EC): 26, Background Noise (BN): 27, Reverberant Room (RV): 28|Mean Difference (Final Values)|0.98|||<|0.0001|TWO_SIDED|95.0|-4.6|6.5||Threshold for statistical significance was p =0.05. p-value was calculated using the estimated difference of benefits, calculating a new t-statistic by subtracting the applicable non-inf. margin from the difference and dividing by standard error.|ANOVA|repeated measures ANOVA where factors are order and treatment is device with patient as a random effect. Added interaction term of treatment and order|Difference calculated as benefit(standard-of-care fit) - benefit(web-app-fit)|Results for Reverberant Room Subscale. Null hypothesis: benefit(standard-of-care fit) - benefit(web-app-fit) \< noninferiority margin for all subscales. Each subscale was analyzed using an rm-ANOVA in which the repeated factors are order \& treatment; no between-group factors. Interaction term was order x treatment. ITT population includes 2 subjects who withdrew. It was concluded that their primary endpoint data was missing for cause and their APHAB benefit scores were imputed as 0.||6.5|-4.6|<0.0001
72356249|NCT00336024|144229886|SUPERIORITY|||||||0.35|||||||Chi-squared|||The CR rates between these two groups will be compared at a significance level of 0.1 using one-sided Chi-square test.||||0.35
72356250|NCT00336024|144229888|SUPERIORITY|||||||0.2|||||||Log Rank|||The difference in incidence for the two treatment regimens will be compared using a one-sided log-rank test with a significance level 0.1.||||0.2
72356251|NCT00336024|144229889|SUPERIORITY|||||||1|||||||Fisher Exact|||The two groups will be compared for patterns of failure to detect a statistically significant difference using Fisher exact test.||||1.00
72356252|NCT00336024|144229890|SUPERIORITY|||||||0.74|||||||Log Rank|||Difference in incidence for the two treatment regimens will be compared using log-rank test.||||0.74
72356253|NCT00336024|144229891|SUPERIORITY|||||||1|||||||Fisher Exact|||The rate of acute hearing loss between two treatment regimens will be be compared using Fisher exact test.||||1.00
72356254|NCT00336024|144229897|SUPERIORITY|||||||0.8|||||||Fisher Exact|||The rate of chronic hearing loss between two treatment regimens will be be compared using Fisher exact test.||||0.8
72356255|NCT00336024|144229898|SUPERIORITY|||||||0.27|||||||Chi-squared|||Rates of gastrointestinal toxicities in Induction Phase I. The difference in number of patients with/without gastrointestinal toxicities between the two treatment regimens will be compared using a Chi-square test.||||0.27
72356256|NCT00336024|144229898|SUPERIORITY|||||||0.07|||||||Chi-squared|||Rates of gastrointestinal toxicities in Induction Phase II. The difference in number of patients with/without gastrointestinal toxicities between the two treatment regimens will be compared using a Chi-square test.||||0.07
72356257|NCT00336024|144229898|SUPERIORITY|||||||0.2|||||||Chi-squared|||Rates of gastrointestinal toxicities in Induction Phase III. The difference in number of patients with/without gastrointestinal toxicities between the two treatment regimens will be compared using a Chi-square test.||||0.2
72356258|NCT00336024|144229898|SUPERIORITY|||||||0.4|||||||Chi-squared|||Rates of gastrointestinal toxicities in Consolidation Phase 1. The difference in number of patients with/without gastrointestinal toxicities between the two treatment regimens will be compared using a Chi-square test.||||0.4
72356259|NCT00336024|144229898|SUPERIORITY|||||||0.38|||||||Chi-squared|||Rates of gastrointestinal toxicities in Consolidation Phase 2. The difference in the number of patients with/without gastrointestinal toxicities between the two treatment regimens will be compared using a Chi-square test.||||0.38
72356260|NCT00336024|144229898|SUPERIORITY|||||||0.7|||||||Chi-squared|||Rates of gastrointestinal toxicities in Consolidation Phase III. The difference in number of patients with/without gastrointestinal toxicities between the two treatment regimens will be compared using a Chi-square test.||||0.7
72356261|NCT00336024|144229899|SUPERIORITY|||||||0.08|||||||Chi-squared|||Rates of nutritional toxicities in Induction Phase I. The difference in number of patients with/without nutritional toxicities between the two treatment regimens will be compared using a Chi-square test.||||0.08
72356262|NCT00336024|144229899|SUPERIORITY|||||||0.9|||||||Chi-squared|||Rates of nutritional toxicities in Induction Phase II. The difference in number of patients with/without nutritional toxicities between the two treatment regimens will be compared using a Chi-square test.||||0.9
72356263|NCT00336024|144229899|SUPERIORITY|||||||0.17|||||||Chi-squared|||Rates of nutritional toxicities in Induction Phase III. The difference in number of patients with/without nutritional toxicities between the two treatment regimens will be compared using a Chi-square test.||||0.17
72356264|NCT00336024|144229899|SUPERIORITY|||||||0.3|||||||Chi-squared|||Rates of nutritional toxicities in Consolidation Phase I. The difference in number of patients with/without nutritional toxicities between the two treatment regimens will be compared using a Chi-square test.||||0.3
72356265|NCT00336024|144229899|SUPERIORITY|||||||0.26|||||||Chi-squared|||Rates of nutritional toxicities in Consolidation Phase II. The difference in number of patients with/without nutritional toxicities between the two treatment regimens will be compared using a Chi-square test.||||0.26
72356266|NCT00336024|144229899|SUPERIORITY|||||||0.17|||||||Chi-squared|||Rates of nutritional toxicities in Consolidation Phase III. The difference in number of patients with/without nutritional toxicities between the two treatment regimens will be compared using a Chi-square test.||||0.17
72356267|NCT00383552|144229913|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|||||||ANCOVA|||||||0.001
72356268|NCT00383552|144229914|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|||||||ANCOVA|||||||0.001
72356269|NCT00383552|144229916|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||ANCOVA|||||||<0.001
72356270|NCT00383552|144229917|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||ANCOVA|||||||<0.001
72356271|NCT00383552|144229918|SUPERIORITY_OR_OTHER_LEGACY|||||||0.073|||||||Longitudinal Model|||||||0.073
72356272|NCT00383552|144229919|SUPERIORITY_OR_OTHER_LEGACY|||||||0.015||||||BMI 25 to \<30|ANCOVA|||||||0.015
72356273|NCT00383552|144229919|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||BMI less than 25 and for BMI 30 or more|ANCOVA|||||||<0.001
72356274|NCT03096834|144229921|SUPERIORITY||Odds Ratio (OR)|2.73||||0.002|TWO_SIDED|95.0|1.43|5.19|||Cochran-Mantel-Haenszel|Adjusted for stratification factor (4-7 vs. 8-14) migraine days at Baseline after missing data are imputed as non-response (NRI).||||5.19|1.43|0.002
72356275|NCT03096834|144229922|SUPERIORITY||Mean Difference (Final Values)|-1.59|STANDARD_ERROR_OF_MEAN|0.55||0.004|TWO_SIDED|95.0|-2.67|-0.51|||Mixed Models Analysis|||Month 3||-0.51|-2.67|0.004
72356276|NCT03096834|144229923|SUPERIORITY||Mean Difference (Final Values)|-3.46|STANDARD_ERROR_OF_MEAN|1.13||0.003|TWO_SIDED|95.0|-5.7|-1.23|||Mixed Models Analysis|||Physical impairment domain||-1.23|-5.70|0.003
72356277|NCT03096834|144229923|SUPERIORITY||Mean Difference (Final Values)|-3.91|STANDARD_ERROR_OF_MEAN|1.12|<|0.001|TWO_SIDED|95.0|-6.12|-1.7|||Mixed Models Analysis|||Everyday activities domain||-1.70|-6.12|<0.001
72356278|NCT03096834|144229924|SUPERIORITY||Mean Difference (Final Values)|-1.71|STANDARD_ERROR_OF_MEAN|0.36|<|0.001|TWO_SIDED|95.0|-2.43|-0.99|||Mixed Models Analysis|||||-0.99|-2.43|<0.001
72356279|NCT03096834|144229925|SUPERIORITY||Odds Ratio (OR)|3.16||||0.025|TWO_SIDED|95.0|1.11|9.01|||Cochran-Mantel-Haenszel|Adjusted for stratification factor (4-7 vs. 8-14) migraine days at Baseline after missing data are imputed as non-response||||9.01|1.11|0.025
72356280|NCT01405768|144229938|SUPERIORITY_OR_OTHER|||||||0.13|||||||Wilcoxon (Mann-Whitney)|||||||.13
72356281|NCT01405768|144229940|SUPERIORITY_OR_OTHER|||||||0.13|||||||Wilcoxon (Mann-Whitney)|||||||.13
72356282|NCT03692208|144229942|OTHER|Quantitative outcomes from chart and survey data were summarized by basic descriptive statistics.|||||<|0.01||||||P-values were calculated. Only P values of \<0.05 were considered statistically significant.|Chi-squared|Chi-squared tests, Fisher's Exact tests, two-sample t-tests, and paired two-sample t-tests were utilized to assess the outcomes between study arms.||||||<0.01
72356283|NCT04245111|144229957|OTHER|No other statistical analysis completed other than percentage of patients completed as reported in the data table section||||||||||||||||No other statistical analysis completed other than percentage of patients completed as reported in the data table section|No other statistical analysis completed other than percentage of patients completed as reported in the data table section|||
72356284|NCT03192176|144229958|SUPERIORITY||LSMean difference|-1.9|STANDARD_ERROR_OF_MEAN|0.84||0.024|TWO_SIDED|95.0|-3.56|-0.25||LS Means(LSM), standard errors(SE), confidence intervals(CI), \& p-values come from an ANCOVA model with CFB as the dependent variable \& treatment group, pooled center, smoking status as factors \& baseline measurement, baseline weight as covariates.|ANCOVA|||||-0.25|-3.56|0.0240
72356285|NCT03192176|144229958|SUPERIORITY||LSMean difference|-3.0|STANDARD_ERROR_OF_MEAN|0.84||0.0004|TWO_SIDED|95.0|-4.68|-1.38||LS Means, SE, CI, and p-values come from an ANCOVA model with change from baseline as the dependent variable and treatment group, pooled center, smoking status as factors and baseline measurement, baseline weight as covariates.|ANCOVA|||||-1.38|-4.68|0.0004
72356286|NCT03192176|144229958|SUPERIORITY||LSMean difference|-2.8|STANDARD_ERROR_OF_MEAN|0.84||0.001|TWO_SIDED|95.0|-4.44|-1.14||LS Means, SE, CI, and p-values come from an ANCOVA model with change from baseline as the dependent variable and treatment group, pooled center, smoking status as factors and baseline measurement, baseline weight as covariates.|ANCOVA|||||-1.14|-4.44|0.0010
72356287|NCT03192176|144229958|SUPERIORITY||LSMean difference|-3.5|STANDARD_ERROR_OF_MEAN|0.84|<|0.0001|TWO_SIDED|95.0|-5.2|-1.89||LS Means, SE, CI, and p-values come from an ANCOVA model with change from baseline as the dependent variable and treatment group, pooled center, smoking status as factors and baseline measurement, baseline weight as covariates.|ANCOVA|||||-1.89|-5.20|<0.0001
72356288|NCT03192176|144229958|SUPERIORITY||LSMean difference|-2.3|STANDARD_ERROR_OF_MEAN|0.84||0.0058||95.0|-4.0|-0.68||LS Means, SE, CI, and p-values come from an ANCOVA model with change from baseline as the dependent variable and treatment group, pooled center, smoking status as factors and baseline measurement, baseline weight as covariates.|ANCOVA|||||-0.68|-4.00|0.0058
72356289|NCT03192176|144229958|SUPERIORITY||LSMean difference|-3.0|STANDARD_ERROR_OF_MEAN|0.82||0.0003|TWO_SIDED|95.0|-4.65|-1.41||LS Means, SE, CI, and p-values come from an ANCOVA model with change from baseline as the dependent variable and treatment group, pooled center, smoking status as factors and baseline measurement, baseline weight as covariates.|ANCOVA|||||-1.41|-4.65|0.0003
72356290|NCT03192176|144229958|SUPERIORITY||LSMean difference|-2.4|STANDARD_ERROR_OF_MEAN|0.84||0.0042|TWO_SIDED|95.0|-4.06|0.76||LS Means, SE, CI, and p-values come from an ANCOVA model with change from baseline as the dependent variable and treatment group, pooled center, smoking status as factors and baseline measurement, baseline weight as covariates.|ANCOVA|||||0.76|-4.06|0.0042
72356291|NCT03192176|144229959|SUPERIORITY||LSMean difference|-1.8|STANDARD_ERROR_OF_MEAN|0.75||0.0154|TWO_SIDED|95.0|-3.3|-0.35||LS Means, SE, CI, and p-values come from an ANCOVA model with change from baseline as the dependent variable and treatment group, pooled center, smoking status as factors and baseline measurement, baseline weight as covariates.|ANCOVA|||||-0.35|-3.30|0.0154
72356292|NCT03192176|144229959|SUPERIORITY||LSMean difference|-2.1|STANDARD_ERROR_OF_MEAN|0.74||0.0043|TWO_SIDED|95.0|-3.6|-0.67||LS Means, SE, CI, and p-values come from an ANCOVA model with change from baseline as the dependent variable and treatment group, pooled center, smoking status as factors and baseline measurement, baseline weight as covariates.|ANCOVA|||||-0.67|-3.60|0.0043
72356293|NCT03192176|144229959|SUPERIORITY||LSMean difference|-2.3|STANDARD_ERROR_OF_MEAN|0.75||0.0023|TWO_SIDED|95.0|-3.76|-0.83||LS Means, SE, CI, and p-values come from an ANCOVA model with change from baseline as the dependent variable and treatment group, pooled center, smoking status as factors and baseline measurement, baseline weight as covariates.|ANCOVA|||||-0.83|-3.76|0.0023
72356294|NCT03192176|144229959|SUPERIORITY||LSMean difference|-2.6|STANDARD_ERROR_OF_MEAN|0.75||0.0005|TWO_SIDED|95.0|-4.09|-1.16||LS Means, SE, CI, and p-values come from an ANCOVA model with change from baseline as the dependent variable and treatment group, pooled center, smoking status as factors and baseline measurement, baseline weight as covariates.|ANCOVA|||||-1.16|-4.09|0.0005
72356295|NCT03192176|144229959|SUPERIORITY||LSMean difference|-2.1|STANDARD_ERROR_OF_MEAN|0.75||0.0064|TWO_SIDED|95.0|-3.52|-0.58||LS Means, SE, CI, and p-values come from an ANCOVA model with change from baseline as the dependent variable and treatment group, pooled center, smoking status as factors and baseline measurement, baseline weight as covariates.|ANCOVA|||||-0.58|-3.52|0.0064
72356296|NCT03192176|144229959|SUPERIORITY||-2.6|-2.6|STANDARD_ERROR_OF_MEAN|0.74||0.0005|TWO_SIDED|95.0|-4.04|-1.15||LS Means, SE, CI, and p-values come from an ANCOVA model with change from baseline as the dependent variable and treatment group, pooled center, smoking status as factors and baseline measurement, baseline weight as covariates.|ANCOVA|||||-1.15|-4.04|0.0005
72356297|NCT03192176|144229959|SUPERIORITY||LSMean difference|-2.1|STANDARD_ERROR_OF_MEAN|0.75||0.0063|TWO_SIDED|95.0|-3.52|-0.59||LS Means, SE, CI, and p-values come from an ANCOVA model with change from baseline as the dependent variable and treatment group, pooled center, smoking status as factors and baseline measurement, baseline weight as covariates.|ANCOVA|||||-0.59|-3.52|0.0063
72356298|NCT03192176|144229960|SUPERIORITY||LSMean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.2||0.0215|TWO_SIDED|95.0|-0.84|-0.07||LS Means, SE, CI, and p-values come from an ANCOVA model with change from baseline as the dependent variable and treatment group, pooled center, smoking status as factors and baseline measurement, baseline weight as covariates.|ANCOVA|||||-0.07|-0.84|0.0215
72356299|NCT03192176|144229960|SUPERIORITY||LSMean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.2||0.0017|TWO_SIDED|95.0|-1.01|-0.24||LS Means, SE, CI, and p-values come from an ANCOVA model with change from baseline as the dependent variable and treatment group, pooled center, smoking status as factors and baseline measurement, baseline weight as covariates.|ANCOVA|||||-0.24|-1.01|0.0017
72356300|NCT03192176|144229960|SUPERIORITY||LSMean difference|-0.8|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001|TWO_SIDED|95.0|-1.21|-0.44||LS Means, SE, CI, and p-values come from an ANCOVA model with change from baseline as the dependent variable and treatment group, pooled center, smoking status as factors and baseline measurement, baseline weight as covariates.|ANCOVA|||||-0.44|-1.21|<0.0001
72356301|NCT03192176|144229960|SUPERIORITY||LSMean difference|-1.0|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001|TWO_SIDED|95.0|-1.37|-0.59||LS Means, SE, CI, and p-values come from an ANCOVA model with change from baseline as the dependent variable and treatment group, pooled center, smoking status as factors and baseline measurement, baseline weight as covariates.|ANCOVA|||||-0.59|-1.37|<0.0001
72356302|NCT03192176|144229960|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.2||0.0322|TWO_SIDED|95.0|-0.81|-0.04||LS Means, SE, CI, and p-values come from an ANCOVA model with change from baseline as the dependent variable and treatment group, pooled center, smoking status as factors and baseline measurement, baseline weight as covariates.|ANCOVA|||||-0.04|-0.81|0.0322
72356303|NCT03192176|144229960|SUPERIORITY||LSMean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.19||0.0017|TWO_SIDED|95.0|-0.99|-0.23||LS Means, SE, CI, and p-values come from an ANCOVA model with change from baseline as the dependent variable and treatment group, pooled center, smoking status as factors and baseline measurement, baseline weight as covariates.|ANCOVA|||||-0.23|-0.99|0.0017
72356304|NCT03192176|144229960|SUPERIORITY||LSMean differencce|-0.7|STANDARD_ERROR_OF_MEAN|0.2||0.0004|TWO_SIDED|95.0|-1.08|-0.31||LS Means, SE, CI, and p-values come from an ANCOVA model with change from baseline as the dependent variable and treatment group, pooled center, smoking status as factors and baseline measurement, baseline weight as covariates.|ANCOVA|||||-0.31|-1.08|0.0004
72356305|NCT03192176|144229961|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.21||0.2324|TWO_SIDED|95.0|-0.67|-0.16||LS Means, SE, CI, and p-values come from an ANCOVA model with change from baseline as the dependent variable and treatment group, pooled center, smoking status as factors and baseline measurement, baseline weight as covariates.|ANCOVA|||||-0.16|-0.67|0.2324
72356306|NCT03192176|144229961|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.21||0.0736|TWO_SIDED|95.0|-0.8|0.04||LS Means, SE, CI, and p-values come from an ANCOVA model with change from baseline as the dependent variable and treatment group, pooled center, smoking status as factors and baseline measurement, baseline weight as covariates.|ANCOVA|||||0.04|-0.80|0.0736
72356307|NCT03192176|144229961|SUPERIORITY||LSMean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.21||0.008|TWO_SIDED|95.0|-0.98|-0.15||LS Means, SE, CI, and p-values come from an ANCOVA model with change from baseline as the dependent variable and treatment group, pooled center, smoking status as factors and baseline measurement, baseline weight as covariates.|ANCOVA|||||-0.15|-0.98|0.0080
72356308|NCT03192176|144229961|SUPERIORITY||LSMean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.21||0.0028|TWO_SIDED|95.0|-1.07|-0.22||LS Means, SE, CI, and p-values come from an ANCOVA model with change from baseline as the dependent variable and treatment group, pooled center, smoking status as factors and baseline measurement, baseline weight as covariates.|ANCOVA|||||-0.22|-1.07|0.0028
72356309|NCT03192176|144229961|SUPERIORITY||LSMean differnce|-0.2|STANDARD_ERROR_OF_MEAN|0.21||0.4647|TWO_SIDED|95.0|-0.58|0.26||LS Means, SE, CI, and p-values come from an ANCOVA model with change from baseline as the dependent variable and treatment group, pooled center, smoking status as factors and baseline measurement, baseline weight as covariates.|ANCOVA|||||0.26|-0.58|0.4647
72356310|NCT03192176|144229961|SUPERIORITY||LSMean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.21||0.016|TWO_SIDED|95.0|-0.92|-0.1||LS Means, SE, CI, and p-values come from an ANCOVA model with change from baseline as the dependent variable and treatment group, pooled center, smoking status as factors and baseline measurement, baseline weight as covariates.|ANCOVA|||||-0.10|-0.92|0.0160
72356311|NCT03192176|144229961|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.21||0.0901|TWO_SIDED|95.0|-0.78|0.06||LS Means, SE, CI, and p-values come from an ANCOVA model with change from baseline as the dependent variable and treatment group, pooled center, smoking status as factors and baseline measurement, baseline weight as covariates.|ANCOVA|||||0.06|-0.78|0.0901
72356312|NCT03192176|144229962|SUPERIORITY||LSMean difference|-1.4|STANDARD_ERROR_OF_MEAN|0.79||0.0865|TWO_SIDED|95.0|-2.92|0.2||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|MMRM: Mixed Model Repeated Measures||Week 1||0.20|-2.92|0.0865
72356313|NCT03192176|144229962|SUPERIORITY||LSMean difference|-2.7|STANDARD_ERROR_OF_MEAN|0.79||0.0009|TWO_SIDED|95.0|-4.22|-1.1||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 1||-1.10|-4.22|0.0009
72356314|NCT03192176|144229962|SUPERIORITY||LSMean difference|-3.5|STANDARD_ERROR_OF_MEAN|0.79|<|1e-05|TWO_SIDED|95.0|-5.06|-1.94||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 1||-1.94|-5.06|<0.00001
72356315|NCT03192176|144229962|SUPERIORITY||LSMean difference|-4.0|STANDARD_ERROR_OF_MEAN|0.8|<|1e-05|TWO_SIDED|95.0|-5.63|-2.47||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 1||-2.47|-5.63|<0.00001
72356316|NCT03192176|144229962|SUPERIORITY||LSMean difference|-1.0|STANDARD_ERROR_OF_MEAN|0.81||0.236|TWO_SIDED|95.0|-2.55|0.63||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 1||0.63|-2.55|0.2360
72356317|NCT03192176|144229962|SUPERIORITY||LSMean difference|-2.4|STANDARD_ERROR_OF_MEAN|-2.4||0.0032|TWO_SIDED|95.0|-3.92|-0.8||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 1||-0.80|-3.92|0.0032
72356318|NCT03192176|144229962|SUPERIORITY||LSMean difference|-2.7|STANDARD_ERROR_OF_MEAN|0.79||0.0006|TWO_SIDED|95.0|-4.29|-1.19||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 1||-1.19|-4.29|0.0006
72356319|NCT03192176|144229962|SUPERIORITY||LSMean difference|-1.2|STANDARD_ERROR_OF_MEAN|0.82||0.1318|TWO_SIDED|95.0|-2.86|0.38||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 2||0.38|-2.86|0.1318
72356320|NCT03192176|144229962|SUPERIORITY||LSMean difference|-2.7|STANDARD_ERROR_OF_MEAN|0.83||0.0014|TWO_SIDED|95.0|-4.3|-1.04||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 2||-1.04|-4.30|0.0014
72356321|NCT03192176|144229962|SUPERIORITY||LSMean differencce|-3.2|STANDARD_ERROR_OF_MEAN|0.82||0.0001|TWO_SIDED|95.0|-4.82|-1.58||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 2||-1.58|-4.82|0.0001
72356322|NCT03192176|144229962|SUPERIORITY||LSMean difference|-3.6|STANDARD_ERROR_OF_MEAN|0.84|<|0.0001|TWO_SIDED|95.0|-5.3|-2.0||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 2||-2.00|-5.30|<0.0001
72356323|NCT03192176|144229962|SUPERIORITY||LSMean difference|-1.5|STANDARD_ERROR_OF_MEAN|0.84||0.0752|TWO_SIDED|95.0|-3.15|0.15||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 2||0.15|-3.15|0.0752
72356324|NCT03192176|144229962|SUPERIORITY||LSMean difference|-1.8|STANDARD_ERROR_OF_MEAN|0.83||0.0343|TWO_SIDED|95.0|-3.38|-0.13||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 2||-0.13|-3.38|0.0343
72356325|NCT03192176|144229962|SUPERIORITY||LSMean difference|-2.3|STANDARD_ERROR_OF_MEAN|0.82||0.0049|TWO_SIDED|95.0|-3.95|-0.71||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 2||-0.71|-3.95|0.0049
72356326|NCT03192176|144229962|SUPERIORITY||LSMean difference|-1.8|STANDARD_ERROR_OF_MEAN|0.84||0.0285|TWO_SIDED|95.0|-3.5|-0.2||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 3||-0.20|-3.50|0.0285
72356327|NCT03192176|144229962|SUPERIORITY||LSMean difference|-3.0|STANDARD_ERROR_OF_MEAN|0.85||0.0004|TWO_SIDED|95.0|-4.69|-1.37||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 3||-1.37|-4.69|0.0004
72356328|NCT03192176|144229962|SUPERIORITY||LSMean difference|-3.5|STANDARD_ERROR_OF_MEAN|0.85|<|0.0001|TWO_SIDED|95.0|-5.14|-1.84||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 3||-1.84|-5.14|<0.0001
72356329|NCT03192176|144229962|SUPERIORITY||LSMean difference|-4.0|STANDARD_ERROR_OF_MEAN|0.86|<|0.0001|TWO_SIDED|95.0|-5.65|-2.28||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRm|||Week 3||-2.28|-5.65|<0.0001
72356330|NCT03192176|144229962|SUPERIORITY||LSMean difference|-2.1|STANDARD_ERROR_OF_MEAN|0.86||0.0169|TWO_SIDED|95.0|-3.74|-0.37||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 3||-0.37|-3.74|0.0169
72356331|NCT03192176|144229962|SUPERIORITY||LSMean difference|-2.4|STANDARD_ERROR_OF_MEAN|0.84||0.0049|TWO_SIDED|95.0|-4.04|-0.73||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 3||-0.73|-4.04|0.0049
72356332|NCT03192176|144229962|SUPERIORITY||LSMean difference|-2.8|STANDARD_ERROR_OF_MEAN|0.84||0.0008|TWO_SIDED|95.0|-4.48|-1.18||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 3||-1.18|-4.48|0.0008
72356333|NCT03192176|144229962|SUPERIORITY||LSMean difference|-1.7|STANDARD_ERROR_OF_MEAN|0.84||0.0428|TWO_SIDED|95.0|-3.36|-0.06||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4||-0.06|-3.36|0.0428
72356334|NCT03192176|144229962|SUPERIORITY||LSMean difference|-3.0|STANDARD_ERROR_OF_MEAN|0.84||0.0004|TWO_SIDED|95.0|-4.65|-1.34||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4||-1.34|-4.65|0.0004
72356335|NCT03192176|144229962|SUPERIORITY||LSMean difference|-3.2|STANDARD_ERROR_OF_MEAN|-0.84||1e-05|TWO_SIDED|95.0|-4.88|-1.58||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4||-1.58|-4.88|0.00001
72356336|NCT03192176|144229962|SUPERIORITY||LSMean difference|-4.1|STANDARD_ERROR_OF_MEAN|0.85|<|0.0001|TWO_SIDED|95.0|-5.73|-2.37||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4||-2.37|-5.73|<0.0001
72356337|NCT03192176|144229962|SUPERIORITY||LSMean difference|-2.0|STANDARD_ERROR_OF_MEAN|0.85||0.0225|TWO_SIDED|95.0|-3.64|-0.28||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4||-0.28|-3.64|0.0225
72356338|NCT03192176|144229962|SUPERIORITY||LSMean difference|-2.8|STANDARD_ERROR_OF_MEAN|0.84||0.0008|TWO_SIDED|95.0|-4.49|-1.19||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4||-1.19|-4.49|0.0008
72356339|NCT03192176|144229962|SUPERIORITY||LSMean difference|-3.1|STANDARD_ERROR_OF_MEAN|0.84||0.0003|TWO_SIDED|95.0|-4.7|-1.42||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4||-1.42|-4.70|0.0003
72356340|NCT03192176|144229962|SUPERIORITY||LSMean difference|-1.2|STANDARD_ERROR_OF_MEAN|0.79||0.1168|TWO_SIDED|95.0|-2.8|0.31||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 5||0.31|-2.80|0.1168
72356341|NCT03192176|144229962|SUPERIORITY||LSMean difference|-2.6|STANDARD_ERROR_OF_MEAN|0.79||0.0012|TWO_SIDED|95.0|-4.15|-1.03||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 5||-1.03|-4.15|0.0012
72356342|NCT03192176|144229962|SUPERIORITY||LSMean difference|-3.0|STANDARD_ERROR_OF_MEAN|0.79||0.0002|TWO_SIDED|95.0|-4.54|-1.42||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 5||-1.42|-4.54|0.0002
72356343|NCT03192176|144229962|SUPERIORITY||LSMean difference|-3.9|STANDARD_ERROR_OF_MEAN|0.8|<|0.0001|TWO_SIDED|95.0|-5.44|-2.28||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 5||-2.28|-5.44|<0.0001
72356344|NCT03192176|144229962|SUPERIORITY||LSMean difference|-2.0|STANDARD_ERROR_OF_MEAN|0.8||0.0134|TWO_SIDED|95.0|-3.58|-0.42||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 5||-0.42|-3.58|0.0134
72356345|NCT03192176|144229962|SUPERIORITY||LSMean difference|-2.2|STANDARD_ERROR_OF_MEAN|0.79||0.0057|TWO_SIDED|95.0|-3.76|-0.65||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 5||-0.65|-3.76|0.0057
72356346|NCT03192176|144229962|SUPERIORITY||LSMean difference|-2.5|STANDARD_ERROR_OF_MEAN|0.79||0.0016|TWO_SIDED|95.0|-4.06|-0.96||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 5||-0.96|-4.06|0.0016
72356347|NCT03192176|144229962|SUPERIORITY||LSMean difference|-1.4|STANDARD_ERROR_OF_MEAN|0.79||0.0843|TWO_SIDED|95.0|-2.94|0.19||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 6||0.19|-2.94|0.0843
72356348|NCT03192176|144229962|SUPERIORITY||LSMean difference|-2.3|STANDARD_ERROR_OF_MEAN|0.8||0.0035|TWO_SIDED|95.0|-3.9|-0.77||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 6||-0.77|-3.90|0.0035
72356349|NCT03192176|144229962|SUPERIORITY||LSMean difference|-3.1|STANDARD_ERROR_OF_MEAN|0.8||0.0001|TWO_SIDED|95.0|-4.66|-1.52||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 6||-1.52|-4.66|0.0001
72356350|NCT03192176|144229962|SUPERIORITY||LSMean difference|-3.7|STANDARD_ERROR_OF_MEAN|0.81|<|0.0001|TWO_SIDED|95.0|-5.28|-2.1||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 6||-2.10|-5.28|<0.0001
72356351|NCT03192176|144229962|SUPERIORITY||LSMean difference|-1.7|STANDARD_ERROR_OF_MEAN|0.81||0.0315|TWO_SIDED|95.0|-3.33|-0.16||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 6||-0.16|-3.33|0.0315
72356352|NCT03192176|144229962|SUPERIORITY||LSMean difference|-2.2|STANDARD_ERROR_OF_MEAN|0.8||0.0063|TWO_SIDED|95.0|-3.75|-0.62||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 6||-0.62|-3.75|0.0063
72356353|NCT03192176|144229962|SUPERIORITY||LSMean difference|-2.7|STANDARD_ERROR_OF_MEAN|0.79||0.0007|TWO_SIDED|95.0|-4.25|-1.14||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 6||-1.14|-4.25|0.0007
72356354|NCT03192176|144229962|SUPERIORITY||LSMean difference|-1.3|STANDARD_ERROR_OF_MEAN|0.81||0.109|TWO_SIDED|95.0|-2.89|0.29||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 7||0.29|-2.89|0.1090
72356355|NCT03192176|144229962|SUPERIORITY||LSMean difference|-2.5|STANDARD_ERROR_OF_MEAN|0.81||0.0018|TWO_SIDED|95.0|-4.14|-0.95||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 7||-0.95|-4.14|0.0018
72356356|NCT03192176|144229962|SUPERIORITY||LSMean difference|-2.9|STANDARD_ERROR_OF_MEAN|0.81||0.0004|TWO_SIDED|95.0|-4.54|-1.34||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 7||-1.34|-4.54|0.0004
72356357|NCT03192176|144229962|SUPERIORITY||LSMean difference|-3.8|STANDARD_ERROR_OF_MEAN|0.83|<|0.0001|TWO_SIDED|95.0|-5.4|-2.15||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 7||-2.15|-5.40|<0.0001
72356358|NCT03192176|144229962|SUPERIORITY||LSMean difference|-1.9|STANDARD_ERROR_OF_MEAN|0.82||0.0231|TWO_SIDED|95.0|-3.5|-0.26||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 7||-0.26|-3.50|0.0231
72356359|NCT03192176|144229962|SUPERIORITY||LSMean difference|-2.3|STANDARD_ERROR_OF_MEAN|0.81||0.0056|TWO_SIDED|95.0|-3.86|-0.67||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 7||-0.67|-3.86|0.0056
72356360|NCT03192176|144229962|SUPERIORITY||LSMean difference|-2.8|STANDARD_ERROR_OF_MEAN|0.81||0.0007|TWO_SIDED|95.0|-4.35|-1.17||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 7||-1.17|-4.35|0.0007
72356361|NCT03192176|144229962|SUPERIORITY||LSMean difference|-0.8|STANDARD_ERROR_OF_MEAN|0.81||0.3568|TWO_SIDED|95.0|-2.35|0.85||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8||0.85|-2.35|0.3568
72356362|NCT03192176|144229962|SUPERIORITY||LSMean difference|-2.0|STANDARD_ERROR_OF_MEAN|0.82||0.0129|TWO_SIDED|95.0|-3.65|-0.43||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8||-0.43|-3.65|0.0129
72356363|NCT03192176|144229962|SUPERIORITY||LSMean difference|-2.6|STANDARD_ERROR_OF_MEAN|0.82||0.0018|TWO_SIDED|95.0|-4.19|-0.97||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8||-0.97|-4.19|0.0018
72356364|NCT03192176|144229962|SUPERIORITY||LSMean difference|-3.1|STANDARD_ERROR_OF_MEAN|0.83||0.0003|TWO_SIDED|95.0|-4.7|-1.42||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8||-1.42|-4.70|0.0003
72356365|NCT03192176|144229962|SUPERIORITY||LSMean difference|-1.4|STANDARD_ERROR_OF_MEAN|0.83||0.1004|TWO_SIDED|95.0|-3.0|0.27||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8||0.27|-3.00|0.1004
72356366|NCT03192176|144229962|SUPERIORITY||LSMean difference|-2.0|STANDARD_ERROR_OF_MEAN|0.82||0.0173|TWO_SIDED|95.0|-3.57|-0.35||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8||-0.35|-3.57|0.0173
72356367|NCT03192176|144229962|SUPERIORITY||LSMean difference|-2.4|STANDARD_ERROR_OF_MEAN|0.81||0.0038|TWO_SIDED|95.0|-3.97|-0.77||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8||-0.77|-3.97|0.0038
72356368|NCT03192176|144229962|SUPERIORITY||LSMean difference|-1.0|STANDARD_ERROR_OF_MEAN|0.78||0.1767|TWO_SIDED|95.0|-2.57|0.48||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 9||0.48|-2.57|0.1767
72356369|NCT03192176|144229962|SUPERIORITY||LSMean difference|-1.7|STANDARD_ERROR_OF_MEAN|0.77||0.0308|TWO_SIDED|95.0|-3.2|-0.16||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 9||-0.16|-3.20|0.0308
72356370|NCT03192176|144229962|SUPERIORITY||LSMean difference|-2.5|STANDARD_ERROR_OF_MEAN|0.78||0.0013|TWO_SIDED|95.0|-4.07|-1.0||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 9||-1.00|-4.07|0.0013
72356371|NCT03192176|144229962|SUPERIORITY||LSMean difference|-2.9|STANDARD_ERROR_OF_MEAN|0.79||0.0003|TWO_SIDED|95.0|-4.47|-1.36||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 9||-1.36|-4.47|0.0003
72356372|NCT03192176|144229962|SUPERIORITY||LSMean difference|-1.0|STANDARD_ERROR_OF_MEAN|0.79||0.2109|TWO_SIDED|95.0|-2.55|0.56||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 9||0.56|-2.55|0.2109
72356373|NCT03192176|144229962|SUPERIORITY||LSMean difference|-1.9|STANDARD_ERROR_OF_MEAN|0.78||0.0152|TWO_SIDED|95.0|-3.44|-0.37||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 9||-0.37|-3.44|0.0152
72356374|NCT03192176|144229962|SUPERIORITY||LSMean difference|-2.1|STANDARD_ERROR_OF_MEAN|0.77||0.0075|TWO_SIDED|95.0|-3.61|-0.56||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 9||-0.56|-3.61|0.0075
72356375|NCT03192176|144229962|SUPERIORITY||LSMean difference|-1.4|STANDARD_ERROR_OF_MEAN|0.8||0.0869|TWO_SIDED|95.0|-2.96|0.2||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 10||0.20|-2.96|0.0869
72356376|NCT03192176|144229962|SUPERIORITY||LSMean difference|-1.6|STANDARD_ERROR_OF_MEAN|0.8||0.052|TWO_SIDED|95.0|-3.14|0.01||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 10||0.01|-3.14|0.0520
72356377|NCT03192176|144229962|SUPERIORITY||LSMean difference|-2.7|STANDARD_ERROR_OF_MEAN|0.81||0.0009|TWO_SIDED|95.0|-4.3|-1.12||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 10||-1.12|-4.30|0.0009
72356378|NCT03192176|144229962|SUPERIORITY||LSMean difference|-3.1|STANDARD_ERROR_OF_MEAN|0.82||0.0002|TWO_SIDED|95.0|-4.68|-1.46||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 10||-1.46|-4.68|0.0002
72356379|NCT03192176|144229962|SUPERIORITY||LSMean difference|-1.6|STANDARD_ERROR_OF_MEAN|0.82||0.0456|TWO_SIDED|95.0|-3.25|-0.03||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Wek 10||-0.03|-3.25|0.0456
72356380|NCT03192176|144229962|SUPERIORITY||LSMean difference|-2.2|STANDARD_ERROR_OF_MEAN|0.81||0.0073|TWO_SIDED|95.0|-3.76|-0.59||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 10||-0.59|-3.76|0.0073
72356381|NCT03192176|144229962|SUPERIORITY||LSMean difference|-2.4|STANDARD_ERROR_OF_MEAN|0.8||0.0026|TWO_SIDED|95.0|-4.01|-0.86||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 10||-0.86|-4.01|0.0026
72356382|NCT03192176|144229962|SUPERIORITY||LSMean difference|-1.3|STANDARD_ERROR_OF_MEAN|0.78||0.0878|TWO_SIDED|95.0|-2.87|0.2||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 11||0.20|-2.87|0.0878
72356383|NCT03192176|144229962|SUPERIORITY||LSMean difference|-1.9|STANDARD_ERROR_OF_MEAN|0.78||0.0182|TWO_SIDED|95.0|-3.39|-0.32||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 11||-0.32|-3.39|0.0182
72356384|NCT03192176|144229962|SUPERIORITY||LSMean difference|-3.0|STANDARD_ERROR_OF_MEAN|0.79||0.0002|TWO_SIDED|95.0|-4.55|-1.44||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 11||-1.44|-4.55|0.0002
72356385|NCT03192176|144229962|SUPERIORITY||LSMean difference|-3.0|STANDARD_ERROR_OF_MEAN|0.8||0.0002|TWO_SIDED|95.0|-4.53|-1.4||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 11||-1.40|-4.53|0.0002
72356386|NCT03192176|144229962|SUPERIORITY||LSMean difference|-1.7|STANDARD_ERROR_OF_MEAN|0.8||0.0387|TWO_SIDED|95.0|-3.22|-0.09||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 11||-0.09|-3.22|0.0387
72356387|NCT03192176|144229962|SUPERIORITY||LSMean difference|-2.3|STANDARD_ERROR_OF_MEAN|0.79||0.0031|TWO_SIDED|95.0|-3.89|-0.8||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 11||-0.80|-3.89|0.0031
72356388|NCT03192176|144229962|SUPERIORITY||LSMean difference|-2.3|STANDARD_ERROR_OF_MEAN|0.78||0.0029|TWO_SIDED|95.0|-3.88|-0.81||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 11||-0.81|-3.88|0.0029
72356389|NCT03192176|144229962|SUPERIORITY||LSMean difference|-1.4|STANDARD_ERROR_OF_MEAN|0.76||0.0653|TWO_SIDED|95.0|-2.9|0.09||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12||0.09|-2.90|0.0653
72356390|NCT03192176|144229962|SUPERIORITY||LSMean difference|-2.0|STANDARD_ERROR_OF_MEAN|0.76||0.0102|TWO_SIDED|95.0|-3.46|-0.47||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12||-0.47|-3.46|0.0102
72356391|NCT03192176|144229962|SUPERIORITY||LSMean difference|-2.9|STANDARD_ERROR_OF_MEAN|0.77||0.0002|TWO_SIDED|95.0|-4.38|-1.36||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12||-1.36|-4.38|0.0002
72356392|NCT03192176|144229962|SUPERIORITY||LSMean difference|-3.2|STANDARD_ERROR_OF_MEAN|0.78|<|0.0001|TWO_SIDED|95.0|-4.72|-1.67||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12||-1.67|-4.72|<0.0001
72356393|NCT03192176|144229962|SUPERIORITY||LSMean difference|-1.8|STANDARD_ERROR_OF_MEAN|0.78||0.0231|TWO_SIDED|95.0|-3.3|-0.25||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12||-0.25|-3.30|0.0231
72356394|NCT03192176|144229962|SUPERIORITY||LSMean difference|-2.4|STANDARD_ERROR_OF_MEAN|0.78||0.0021|TWO_SIDED|95.0|-3.88|-0.87||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12||-0.87|-3.88|0.0021
72356395|NCT03192176|144229962|SUPERIORITY||LSMean difference|-2.4|STANDARD_ERROR_OF_MEAN|0.76||0.0021|TWO_SIDED|95.0|-3.88|-0.87||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12||-0.87|-3.88|0.0021
72356396|NCT03192176|144229962|SUPERIORITY||LSMean difference|-2.5|STANDARD_ERROR_OF_MEAN|0.76||0.0013|TWO_SIDED|95.0|-3.96|-0.97||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12||-0.97|-3.96|0.0013
72356397|NCT03192176|144229962|SUPERIORITY||LSMean difference|-1.2|STANDARD_ERROR_OF_MEAN|0.84||0.146|TWO_SIDED|95.0|-2.89|0.43||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 13||0.43|-2.89|0.1460
72356398|NCT03192176|144229962|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.84||0.6066|TWO_SIDED|95.0|-2.1|1.23||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMMRM|||Week 13||1.23|-2.10|0.6066
72356399|NCT03192176|144229962|SUPERIORITY||LSMean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.87||0.8422|TWO_SIDED|95.0|-1.88|1.54||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 13||1.54|-1.88|0.8422
72356400|NCT03192176|144229962|SUPERIORITY||LSMean difference|-1.0|STANDARD_ERROR_OF_MEAN|0.87||0.2346|TWO_SIDED|95.0|-2.74|0.67||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|LSMean difference|||Week 13||0.67|-2.74|0.2346
72356401|NCT03192176|144229962|SUPERIORITY||LSMean difference|-1.4|STANDARD_ERROR_OF_MEAN|0.87||0.1128|TWO_SIDED|95.0|-3.11|0.33||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 13||0.33|-3.11|0.1128
72356402|NCT03192176|144229962|SUPERIORITY||LSMean difference|-1.2|STANDARD_ERROR_OF_MEAN|0.87||0.1811|TWO_SIDED|95.0|-2.89|0.55||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 13||0.55|-2.89|0.1811
72356403|NCT03192176|144229962|SUPERIORITY||LSMean difference|-0.8|STANDARD_ERROR_OF_MEAN|0.84||0.3521|TWO_SIDED|95.0|-2.45|0.87||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 13||0.87|-2.45|0.3521
72356404|NCT03192176|144229962|SUPERIORITY||LSMean difference|-0.8|STANDARD_ERROR_OF_MEAN|0.84||0.357|TWO_SIDED|95.0|-2.44|0.88||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 14||0.88|-2.44|0.3570
72356405|NCT03192176|144229962|SUPERIORITY||LSMean differencce|-0.1|STANDARD_ERROR_OF_MEAN|0.84||0.9227|TWO_SIDED|95.0|-1.73|1.57||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 14||1.57|-1.73|0.9227
72356406|NCT03192176|144229962|SUPERIORITY||LSMean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.87||0.8894|TWO_SIDED|95.0|-1.84|1.6||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 14||1.60|-1.84|0.8894
72356407|NCT03192176|144229962|SUPERIORITY||LSMean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.87||0.5074|TWO_SIDED|95.0|-2.29|1.13||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 14||1.13|-2.29|0.5074
72356408|NCT03192176|144229962|SUPERIORITY||LSMean differencce|-1.2|STANDARD_ERROR_OF_MEAN|0.87||0.1753|TWO_SIDED|95.0|-2.91|0.53||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 14||0.53|-2.91|0.1753
72356409|NCT03192176|144229962|SUPERIORITY||LSMean difference|-1.4|STANDARD_ERROR_OF_MEAN|0.88||0.1212|TWO_SIDED|95.0|-3.09|0.36||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 14||0.36|-3.09|0.1212
72356410|NCT03192176|144229962|SUPERIORITY||LSMean difference|-0.8|STANDARD_ERROR_OF_MEAN|0.84||0.3702|TWO_SIDED|95.0|-2.41|0.9||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 14||0.90|-2.41|0.3702
72356411|NCT03192176|144229962|SUPERIORITY||LSMean difference|0.4|STANDARD_ERROR_OF_MEAN|0.81||0.6459|TWO_SIDED|95.0|-1.22|1.96||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15||1.96|-1.22|0.6459
72356412|NCT03192176|144229962|SUPERIORITY||LSMean difference|0.2|STANDARD_ERROR_OF_MEAN|0.8||0.8248|TWO_SIDED|95.0|-1.4|1.75||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15||1.75|-1.40|0.8248
72356413|NCT03192176|144229962|SUPERIORITY||LSMean difference|0.7|STANDARD_ERROR_OF_MEAN|0.84||0.4226|TWO_SIDED|95.0|-0.98|2.33||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15||2.33|-0.98|0.4226
72356414|NCT03192176|144229962|SUPERIORITY||LSMean difference|0.4|STANDARD_ERROR_OF_MEAN|0.83||0.6469|TWO_SIDED|95.0|-1.25|2.01||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15||2.01|-1.25|0.6469
72356415|NCT03192176|144229962|SUPERIORITY||LSMean difference|0.3|STANDARD_ERROR_OF_MEAN|0.84||0.7642|TWO_SIDED|95.0|-1.41|1.91||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15||1.91|-1.41|0.7642
72356416|NCT03192176|144229962|SUPERIORITY||LSMean difference|-0.7|STANDARD_ERROR_OF_MEAN|0.84||0.4068|TWO_SIDED|95.0|-2.36|0.966||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15||0.966|-2.36|0.4068
72356417|NCT03192176|144229962|SUPERIORITY||LSMean difference|0.2|STANDARD_ERROR_OF_MEAN|0.8||0.7974|TWO_SIDED|95.0|-1.37|1.78||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15||1.78|-1.37|0.7974
72356418|NCT03192176|144229963|SUPERIORITY||LSMean difference|-1.7|STANDARD_ERROR_OF_MEAN|0.78||0.0297|TWO_SIDED|95.0|-3.23|-0.17||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 1||-0.17|-3.23|0.0297
72356419|NCT03192176|144229963|SUPERIORITY||LSMean difference|-3.1|STANDARD_ERROR_OF_MEAN|0.78|<|0.0001|TWO_SIDED|95.0|-4.66|-1.58||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 1||-1.58|-4.66|<0.0001
72356420|NCT03192176|144229963|SUPERIORITY||LSMean difference|-3.6|STANDARD_ERROR_OF_MEAN|0.78|<|1e-05|TWO_SIDED|95.0|-5.1|-2.02||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 1||-2.02|-5.10|<0.00001
72356421|NCT03192176|144229963|SUPERIORITY||LSMean difference|-4.2|STANDARD_ERROR_OF_MEAN|0.79|<|0.0001|TWO_SIDED|95.0|-5.78|-2.66||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 1||-2.66|-5.78|<0.0001
72356422|NCT03192176|144229963|SUPERIORITY||LSMean difference|-1.2|STANDARD_ERROR_OF_MEAN|0.79||0.1318|TWO_SIDED|95.0|-2.76|0.36||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 1||0.36|-2.76|0.1318
72356423|NCT03192176|144229963|SUPERIORITY||LSMean difference|-2.6|STANDARD_ERROR_OF_MEAN|0.78||0.001|TWO_SIDED|95.0|-4.13|-1.05||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 1||-1.05|-4.13|0.0010
72356424|NCT03192176|144229963|SUPERIORITY||LSMean difference|-2.6|STANDARD_ERROR_OF_MEAN|0.78||0.0011|TWO_SIDED|95.0|-4.1|-1.04||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 1||-1.04|-4.10|0.0011
72356425|NCT03192176|144229963|SUPERIORITY||LSMean difference|-1.6|STANDARD_ERROR_OF_MEAN|0.79||0.0405|TWO_SIDED|95.0|-3.2|-0.07||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 2||-0.07|-3.20|0.0405
72356426|NCT03192176|144229963|SUPERIORITY||LSMean difference|-3.1|STANDARD_ERROR_OF_MEAN|0.8||0.0001|TWO_SIDED|95.0|-4.7|-1.55||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 2||-1.55|-4.70|0.0001
72356427|NCT03192176|144229963|SUPERIORITY||LSMean differencce|-3.1|STANDARD_ERROR_OF_MEAN|0.8||0.0001|TWO_SIDED|95.0|-4.66|-1.52||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 2||-1.52|-4.66|0.0001
72356428|NCT03192176|144229963|SUPERIORITY||LSMean difference|-3.7|STANDARD_ERROR_OF_MEAN|0.81|<|0.0001|TWO_SIDED|95.0|-5.26|-2.07||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 2||-2.07|-5.26|<0.0001
72356429|NCT03192176|144229963|SUPERIORITY||LSMean difference|-1.7|STANDARD_ERROR_OF_MEAN|0.81||0.0325|TWO_SIDED|95.0|-3.34|-0.15||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 2||-0.15|-3.34|0.0325
72356430|NCT03192176|144229963|SUPERIORITY||LSMean difference|-2.4|STANDARD_ERROR_OF_MEAN|0.8||0.0035|TWO_SIDED|95.0|-3.92|-0.78||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 2||-0.78|-3.92|0.0035
72356431|NCT03192176|144229963|SUPERIORITY||LSMean difference|-2.1|STANDARD_ERROR_OF_MEAN|0.79||0.0102|TWO_SIDED|95.0|-3.61|-0.49||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 2||-0.49|-3.61|0.0102
72356432|NCT03192176|144229963|SUPERIORITY||LSMean difference|-2.1|STANDARD_ERROR_OF_MEAN|0.81||0.0098|TWO_SIDED|95.0|-3.69|-0.51||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 3||-0.51|-3.69|0.0098
72356433|NCT03192176|144229963|SUPERIORITY||LSMean difference|-3.6|STANDARD_ERROR_OF_MEAN|0.81|<|0.0001|TWO_SIDED|95.0|-5.18|-1.98||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 3||-1.98|-5.18|<0.0001
72356434|NCT03192176|144229963|SUPERIORITY||LSMean difference|-3.3|STANDARD_ERROR_OF_MEAN|0.81|<|0.0001|TWO_SIDED|95.0|-4.89|-1.7||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 3||-1.70|-4.89|<0.0001
72356435|NCT03192176|144229963|SUPERIORITY||LSMean difference|-4.0|STANDARD_ERROR_OF_MEAN|0.82|<|0.0001|TWO_SIDED|95.0|-5.61|-2.37||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 3||-2.37|-5.61|<0.0001
72356436|NCT03192176|144229963|SUPERIORITY||LSMean difference|-2.6|STANDARD_ERROR_OF_MEAN|0.82||0.0021|TWO_SIDED|95.0|-4.17|-0.93||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 3||-0.93|-4.17|0.0021
72356437|NCT03192176|144229963|SUPERIORITY||LSMean difference|-3.1|STANDARD_ERROR_OF_MEAN|0.81||0.0001|TWO_SIDED|95.0|-4.71|-1.52||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 3||-1.52|-4.71|0.0001
72356438|NCT03192176|144229963|SUPERIORITY||LSMean difference|-2.5|STANDARD_ERROR_OF_MEAN|0.81||0.002|TWO_SIDED|95.0|-4.11|-0.93||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 3||-0.93|-4.11|0.0020
72356439|NCT03192176|144229963|SUPERIORITY||LSMean difference|-1.8|STANDARD_ERROR_OF_MEAN|0.76||0.021|TWO_SIDED|95.0|-3.27|-0.27||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 5||-0.27|-3.27|0.0210
72356440|NCT03192176|144229963|SUPERIORITY||LSMean difference|-3.1|STANDARD_ERROR_OF_MEAN|0.77|<|0.0001|TWO_SIDED|95.0|-4.59|-1.58||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 5||-1.58|-4.59|<0.0001
72356441|NCT03192176|144229963|SUPERIORITY||LSMean difference|-2.88|STANDARD_ERROR_OF_MEAN|0.77||0.0003|TWO_SIDED|95.0|-4.34|-1.33||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 5||-1.33|-4.34|0.0003
72356442|NCT03192176|144229963|SUPERIORITY||LSMean difference|-3.8|STANDARD_ERROR_OF_MEAN|0.73|<|0.0001|TWO_SIDED|95.0|-5.29|-2.23||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 5||-2.23|-5.29|<0.0001
72356443|NCT03192176|144229963|SUPERIORITY||LSMean difference|-2.4|STANDARD_ERROR_OF_MEAN|0.77||0.0023|TWO_SIDED|95.0|-3.91|-0.86||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 5||-0.86|-3.91|0.0023
72356444|NCT03192176|144229963|SUPERIORITY||LSMean difference|-2.7|STANDARD_ERROR_OF_MEAN|0.76||0.0004|TWO_SIDED|95.0|-4.25|-1.24||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 5||-1.24|-4.25|0.0004
72356445|NCT03192176|144229963|SUPERIORITY||LSMean difference|-2.2|STANDARD_ERROR_OF_MEAN|0.76||0.0036|TWO_SIDED|95.0|-3.73|-0.74||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 5||-0.74|-3.73|0.0036
72356446|NCT03192176|144229963|SUPERIORITY||LSMean difference|-1.8|STANDARD_ERROR_OF_MEAN|0.77||0.0195|TWO_SIDED|95.0|-3.33|-0.29||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 6||-0.29|-3.33|0.0195
72356447|NCT03192176|144229963|SUPERIORITY||LSMean difference|-2.7|STANDARD_ERROR_OF_MEAN|0.77||0.0006|TWO_SIDED|95.0|-4.21|-1.17||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 6||-1.17|-4.21|0.0006
72356448|NCT03192176|144229963|SUPERIORITY||LSMean difference|-2.8|STANDARD_ERROR_OF_MEAN|0.77||0.0004|TWO_SIDED|95.0|-4.32|-1.27||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 6||-1.27|-4.32|0.0004
72356449|NCT03192176|144229963|SUPERIORITY||LSMean difference|-3.5|STANDARD_ERROR_OF_MEAN|0.79|<|0.0001|TWO_SIDED|95.0|-5.01|-1.92||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 6||-1.92|-5.01|<0.0001
72356450|NCT03192176|144229963|SUPERIORITY||LSMean difference|-2.2|STANDARD_ERROR_OF_MEAN|0.78||0.0061|TWO_SIDED|95.0|-3.71|-0.62||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 6||-0.62|-3.71|0.0061
72356451|NCT03192176|144229963|SUPERIORITY||LSMean difference|-2.7|STANDARD_ERROR_OF_MEAN|0.77||0.0006|TWO_SIDED|95.0|-4.19|-1.14||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 6||-1.14|-4.19|0.0006
72356452|NCT03192176|144229963|SUPERIORITY||LSMean difference|-2.3|STANDARD_ERROR_OF_MEAN|0.77||0.003|TWO_SIDED|95.0|-3.81|-0.78||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 6||-0.78|-3.81|0.0030
72356453|NCT03192176|144229963|SUPERIORITY||LSMean difference|-1.6|STANDARD_ERROR_OF_MEAN|0.78||0.0383|TWO_SIDED|95.0|-3.17|-0.09||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 7||-0.09|-3.17|0.0383
72356454|NCT03192176|144229963|SUPERIORITY||LSMean difference|-2.8|STANDARD_ERROR_OF_MEAN|0.79||0.0004|TWO_SIDED|95.0|-4.33|-1.24||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 7||-1.24|-4.33|0.0004
72356455|NCT03192176|144229963|SUPERIORITY||LSMean difference|-2.6|STANDARD_ERROR_OF_MEAN|0.79||0.0011|TWO_SIDED|95.0|-4.14|-1.04||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 7||-1.04|-4.14|0.0011
72356456|NCT03192176|144229963|SUPERIORITY||LSMean difference|-3.5|STANDARD_ERROR_OF_MEAN|0.8|<|0.0001|TWO_SIDED|95.0|-5.07|-1.93||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 7||-1.93|-5.07|<0.0001
72356457|NCT03192176|144229963|SUPERIORITY||LSMean difference|-2.2|STANDARD_ERROR_OF_MEAN|0.8||0.0055|TWO_SIDED|95.0|-3.8|-0.66||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 7||-0.66|-3.80|0.0055
72356458|NCT03192176|144229963|SUPERIORITY||LSMean difference|-2.5|STANDARD_ERROR_OF_MEAN|0.79||0.0014|TWO_SIDED|95.0|-4.09|-0.99||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 7||-0.99|-4.09|0.0014
72356459|NCT03192176|144229963|SUPERIORITY||LSMean difference|-2.3|STANDARD_ERROR_OF_MEAN|0.78||0.004|TWO_SIDED|95.0|-3.8|-0.73||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 7||-0.73|-3.80|0.0040
72356460|NCT03192176|144229963|SUPERIORITY||LSMean difference|-1.1|STANDARD_ERROR_OF_MEAN|0.78||0.1502|TWO_SIDED|95.0|-2.68|0.41||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8||0.41|-2.68|0.1502
72356461|NCT03192176|144229963|SUPERIORITY||LSMean difference|-2.2|STANDARD_ERROR_OF_MEAN|0.79||0.0057|TWO_SIDED|95.0|-3.74|-0.64||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8||-0.64|-3.74|0.0057
72356462|NCT03192176|144229963|SUPERIORITY||LSMean difference|-2.2|STANDARD_ERROR_OF_MEAN|0.79||0.0054|TWO_SIDED|95.0|-3.76|-0.66||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8||-0.66|-3.76|0.0054
72356463|NCT03192176|144229963|SUPERIORITY||LSMean difference|-2.8|STANDARD_ERROR_OF_MEAN|0.8||0.0006|TWO_SIDED|95.0|-4.38|-1.22||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8||-1.22|-4.38|0.0006
72356464|NCT03192176|144229963|SUPERIORITY||LSMean difference|-1.6|STANDARD_ERROR_OF_MEAN|0.8||0.0412|TWO_SIDED|95.0|-3.21|-0.07||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8||-0.07|-3.21|0.0412
72356465|NCT03192176|144229963|SUPERIORITY||LSMean difference|-2.2|STANDARD_ERROR_OF_MEAN|0.79||0.0054|TWO_SIDED|95.0|-3.76|-0.66||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8||-0.66|-3.76|0.0054
72356466|NCT03192176|144229963|SUPERIORITY||LSMean difference|-1.9|STANDARD_ERROR_OF_MEAN|0.78||0.0167|TWO_SIDED|95.0|-3.43|-0.34||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8||-0.34|-3.43|0.0167
72356467|NCT03192176|144229963|SUPERIORITY||LSMean difference|-1.5|STANDARD_ERROR_OF_MEAN|0.75||0.0533|TWO_SIDED|95.0|-2.94|0.02||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 9||0.02|-2.94|0.0533
72356468|NCT03192176|144229963|SUPERIORITY||LSMean difference|-2.1|STANDARD_ERROR_OF_MEAN|0.75||0.0065|TWO_SIDED|95.0|-3.54|-0.58||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 9||-0.58|-3.54|0.0065
72356469|NCT03192176|144229963|SUPERIORITY||LSMean difference|-2.3|STANDARD_ERROR_OF_MEAN|0.76||0.0025|TWO_SIDED|95.0|-3.8|-0.82||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 9||-0.82|-3.80|0.0025
72356470|NCT03192176|144229963|SUPERIORITY||LSMean difference|-2.7|STANDARD_ERROR_OF_MEAN|0.77||0.0005|TWO_SIDED|95.0|-4.22|-1.2||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 9||-1.20|-4.22|0.0005
72356471|NCT03192176|144229963|SUPERIORITY||LSMean difference|-1.5|STANDARD_ERROR_OF_MEAN|0.77||0.0541|TWO_SIDED|95.0|-2.99|0.03||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 9||0.03|-2.99|0.0541
72356472|NCT03192176|144229963|SUPERIORITY||LSMean difference|-2.2|STANDARD_ERROR_OF_MEAN|0.76||0.0039|TWO_SIDED|95.0|-3.69|-0.71||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 9||-0.71|-3.69|0.0039
72356473|NCT03192176|144229963|SUPERIORITY||LSMean difference|-1.7|STANDARD_ERROR_OF_MEAN|0.75||0.0245|TWO_SIDED|95.0|-3.18|-0.22||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 9||-0.22|-3.18|0.0245
72356474|NCT03192176|144229963|SUPERIORITY||LSMean difference|-1.8|STANDARD_ERROR_OF_MEAN|0.78||0.0187|TWO_SIDED|95.0|-3.36|-0.31||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 10||-0.31|-3.36|0.0187
72356475|NCT03192176|144229963|SUPERIORITY||LSMean difference|-2.1|STANDARD_ERROR_OF_MEAN|0.78||0.006|TWO_SIDED|95.0|-3.68|-0.62||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 10||-0.62|-3.68|0.0060
72356476|NCT03192176|144229963|SUPERIORITY||LSMean difference|-2.5|STANDARD_ERROR_OF_MEAN|0.78||0.0014|TWO_SIDED|95.0|-4.06|-0.98||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 10||-0.98|-4.06|0.0014
72356477|NCT03192176|144229963|SUPERIORITY||LSMean difference|-2.9|STANDARD_ERROR_OF_MEAN|0.79||0.0003|TWO_SIDED|95.0|-4.49|-1.37||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 10||-1.37|-4.49|0.0003
72356478|NCT03192176|144229963|SUPERIORITY||LSMean difference|-2.1|STANDARD_ERROR_OF_MEAN|0.79||0.01|TWO_SIDED|95.0|-3.61|-0.49||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 10||-0.49|-3.61|0.0100
72356479|NCT03192176|144229963|SUPERIORITY||LSMean difference|-2.4|STANDARD_ERROR_OF_MEAN|0.78||0.0019|TWO_SIDED|95.0|-3.98|-0.91||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 10||-0.91|-3.98|0.0019
72356480|NCT03192176|144229963|SUPERIORITY||LSMean difference|-2.2|STANDARD_ERROR_OF_MEAN|0.78||0.0049|TWO_SIDED|95.0|-3.73|-0.67||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 10||-0.67|-3.73|0.0049
72356481|NCT03192176|144229963|SUPERIORITY||LSMean difference|-1.8|STANDARD_ERROR_OF_MEAN|0.75||0.0186|TWO_SIDED|95.0|-3.25|-0.3||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 11||-0.30|-3.25|0.0186
72356482|NCT03192176|144229963|SUPERIORITY||LSMean difference|-2.3|STANDARD_ERROR_OF_MEAN|0.75||0.0024|TWO_SIDED|95.0|-3.77|-0.82||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 11||-0.82|-3.77|0.0024
72356483|NCT03192176|144229963|SUPERIORITY||LSMean difference|-2.8|STANDARD_ERROR_OF_MEAN|0.76||0.0003|TWO_SIDED|95.0|-4.28|-1.3||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 11||-1.30|-4.28|0.0003
72356484|NCT03192176|144229963|SUPERIORITY||LSMean difference|-2.8|STANDARD_ERROR_OF_MEAN|0.77||0.0003|TWO_SIDED|95.0|-4.3|-1.29||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 11||-1.29|-4.30|0.0003
72356485|NCT03192176|144229963|SUPERIORITY||LSMean difference|-2.1|STANDARD_ERROR_OF_MEAN|0.76||0.0058|TWO_SIDED|95.0|-3.63|-0.62||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 11||-0.62|-3.63|0.0058
72356486|NCT03192176|144229963|SUPERIORITY||LSMean difference|-2.6|STANDARD_ERROR_OF_MEAN|0.75||0.0008|TWO_SIDED|95.0|-4.04|-1.7||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 11||-1.7|-4.04|0.0008
72356487|NCT03192176|144229963|SUPERIORITY||LSMean difference|-2.1|STANDARD_ERROR_OF_MEAN|0.75||0.005|TWO_SIDED|95.0|-3.59|-0.64||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 11||-0.64|-3.59|0.0050
72356488|NCT03192176|144229963|SUPERIORITY||LSMean difference|-2.0|STANDARD_ERROR_OF_MEAN|0.85||0.0205|TWO_SIDED|95.0|-3.63|-0.31||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 13||-0.31|-3.63|0.0205
72356489|NCT03192176|144229963|SUPERIORITY||LSMean difference|-0.9|STANDARD_ERROR_OF_MEAN|0.85||0.2818|TWO_SIDED|95.0|-2.58|0.75||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMMRM|||Week 13||0.75|-2.58|0.2818
72356490|NCT03192176|144229963|SUPERIORITY||LSMean difference|-0.9|STANDARD_ERROR_OF_MEAN|0.87||0.3102|TWO_SIDED|95.0|-2.6|0.83||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 13||0.83|-2.60|0.3102
72356491|NCT03192176|144229963|SUPERIORITY||LSMean difference|-1.3|STANDARD_ERROR_OF_MEAN|0.87||0.1422|TWO_SIDED|95.0|-2.99|0.43||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|LSMean difference|||Week 13||0.43|-2.99|0.1422
72356492|NCT03192176|144229963|SUPERIORITY||LSMean difference|-2.4|STANDARD_ERROR_OF_MEAN|0.87||0.0064|TWO_SIDED|95.0|-4.12|-0.68||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 13||-0.68|-4.12|0.0064
72356493|NCT03192176|144229963|SUPERIORITY||LSMean difference|-1.6|STANDARD_ERROR_OF_MEAN|0.87||0.0752|TWO_SIDED|95.0|-3.28|0.16||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 13||0.16|-3.28|0.0752
72356494|NCT03192176|144229963|SUPERIORITY||LSMean difference|-0.8|STANDARD_ERROR_OF_MEAN|0.85||0.3632|TWO_SIDED|95.0|-2.43|0.89||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 13||0.89|-2.43|0.3632
72356495|NCT03192176|144229963|SUPERIORITY||LSMean differencce|-1.6|STANDARD_ERROR_OF_MEAN|0.87||0.0625|TWO_SIDED|95.0|-3.32|0.09||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 14||0.09|-3.32|0.0625
72356496|NCT03192176|144229963|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.86||0.6613|TWO_SIDED|95.0|-2.07|1.32||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 14||1.32|-2.07|0.6613
72356497|NCT03192176|144229963|SUPERIORITY||LSMean difference|-0.7|STANDARD_ERROR_OF_MEAN|0.9||0.4209|TWO_SIDED|95.0|-2.48|1.04||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 14||1.04|-2.48|0.4209
72356498|NCT03192176|144229963|SUPERIORITY||LSMean differencce|-0.9|STANDARD_ERROR_OF_MEAN|0.89||0.3288|TWO_SIDED|95.0|-2.63|0.88||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 14||0.88|-2.63|0.3288
72356499|NCT03192176|144229963|SUPERIORITY||LSMean difference|-2.1|STANDARD_ERROR_OF_MEAN|0.9||0.0202|TWO_SIDED|95.0|-3.86|-0.33||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 14||-0.33|-3.86|0.0202
72356500|NCT03192176|144229963|SUPERIORITY||LSMean difference|-1.6|STANDARD_ERROR_OF_MEAN|0.9||0.0682|TWO_SIDED|95.0|-3.42|0.12||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 14||0.12|-3.42|0.0682
72356501|NCT03192176|144229963|SUPERIORITY||LSMean difference|-0.7|STANDARD_ERROR_OF_MEAN|0.86||0.3912|TWO_SIDED|95.0|-2.44|0.96||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 14||0.96|-2.44|0.3912
72356502|NCT03192176|144229963|SUPERIORITY||LSMean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.85||0.4964|TWO_SIDED|95.0|-2.25|1.09||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15||1.09|-2.25|0.4964
72356503|NCT03192176|144229963|SUPERIORITY||LSMean difference|0.0|STANDARD_ERROR_OF_MEAN|0.84||0.983|TWO_SIDED|95.0|-1.64|1.68||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15||1.68|-1.64|0.9830
72356504|NCT03192176|144229963|SUPERIORITY||LSMean difference|0.0|STANDARD_ERROR_OF_MEAN|0.89||0.9715|TWO_SIDED|95.0|-1.71|1.78||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15||1.78|-1.71|0.9715
72356505|NCT03192176|144229963|SUPERIORITY||LSMean difference|0.1|STANDARD_ERROR_OF_MEAN|0.87||0.8715|TWO_SIDED|95.0|-1.58|1.86||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15||1.86|-1.58|0.8715
72356506|NCT03192176|144229963|SUPERIORITY||LSMean difference|-1.1|STANDARD_ERROR_OF_MEAN|0.89||0.2233|TWO_SIDED|95.0|-2.83|0.66||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15||0.66|-2.83|0.2233
72356507|NCT03192176|144229963|SUPERIORITY||LSMean difference|-0.9|STANDARD_ERROR_OF_MEAN|0.89||0.2882|TWO_SIDED|95.0|-2.69|0.8||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15||0.80|-2.69|0.2882
72356508|NCT03192176|144229963|SUPERIORITY||LSMean difference|0.1|STANDARD_ERROR_OF_MEAN|0.84||0.8643||95.0|-1.52|1.8||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15||1.80|-1.52|0.8643
72356509|NCT03192176|144229964|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.12||0.0104|TWO_SIDED|95.0|-0.53|-0.07||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 1||-0.07|-0.53|0.0104
72356510|NCT03192176|144229964|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.12||0.006|TWO_SIDED|95.0|-0.56|-0.09||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 1||-0.09|-0.56|0.0060
72356511|NCT03192176|144229964|SUPERIORITY||LSMean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-0.71|-0.24||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 1||-0.24|-0.71|<0.0001
72356512|NCT03192176|144229964|SUPERIORITY||LSMean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-0.85|-0.38||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 1||-0.38|-0.85|<0.0001
72356513|NCT03192176|144229964|SUPERIORITY||LSMean difference|0.0|STANDARD_ERROR_OF_MEAN|0.12||0.6977|TWO_SIDED|95.0|-0.28|0.19||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 1||0.19|-0.28|0.6977
72356514|NCT03192176|144229964|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.12||0.0121|TWO_SIDED|95.0|-0.53|-0.07||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 1||-0.07|-0.53|0.0121
72356515|NCT03192176|144229964|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.12||0.0086|TWO_SIDED|95.0|-0.54|-0.08||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 1||-0.08|-0.54|0.0086
72356516|NCT03192176|144229964|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.15||0.0138|TWO_SIDED|95.0|-0.66|-0.08||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 2||-0.08|-0.66|0.0138
72356517|NCT03192176|144229964|SUPERIORITY||LSMean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.15||0.0014|TWO_SIDED|95.0|-0.78|-0.19||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 2||-0.19|-0.78|0.0014
72356518|NCT03192176|144229964|SUPERIORITY||LSMean differencce|-0.7|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-1.02|-0.43||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 2||-0.43|-1.02|<0.0001
72356519|NCT03192176|144229964|SUPERIORITY||LSMean difference|-0.9|STANDARD_ERROR_OF_MEAN|0.15|<|0.0001|TWO_SIDED|95.0|-1.19|-0.59||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 2||-0.59|-1.19|<0.0001
72356520|NCT03192176|144229964|SUPERIORITY||LSMean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.15||0.2831|TWO_SIDED|95.0|-0.46|0.14||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 2||0.14|-0.46|0.2831
72356521|NCT03192176|144229964|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.15||0.0051|TWO_SIDED|95.0|-0.72|-0.13||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 2||-0.13|-0.72|0.0051
72356522|NCT03192176|144229964|SUPERIORITY||LSMean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.15||0.0006|TWO_SIDED|95.0|-0.81|-0.22||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 2||-0.22|-0.81|0.0006
72356523|NCT03192176|144229964|SUPERIORITY||LSMean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.17||0.0058|TWO_SIDED|95.0|-0.83|-0.14||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 3||-0.14|-0.83|0.0058
72356524|NCT03192176|144229964|SUPERIORITY||LSMean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.18||0.0004|TWO_SIDED|95.0|-0.97|-0.28||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 3||-0.28|-0.97|0.0004
72356525|NCT03192176|144229964|SUPERIORITY||LSMean difference|-0.8|STANDARD_ERROR_OF_MEAN|0.17|<|0.0001|TWO_SIDED|95.0|-1.14|-0.46||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 3||-0.46|-1.14|<0.0001
72356526|NCT03192176|144229964|SUPERIORITY||LSMean difference|-0.9|STANDARD_ERROR_OF_MEAN|0.18|<|0.0001|TWO_SIDED|95.0|-1.27|-0.57||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 3||-0.57|-1.27|<0.0001
72356527|NCT03192176|144229964|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.18||0.0807|TWO_SIDED|95.0|-0.66|0.04||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 3||0.04|-0.66|0.0807
72356528|NCT03192176|144229964|SUPERIORITY||LSMean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.18||0.0014|TWO_SIDED|95.0|-0.91|-0.22||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 3||-0.22|-0.91|0.0014
72356529|NCT03192176|144229964|SUPERIORITY||LSMean difference|-0.7|STANDARD_ERROR_OF_MEAN|0.17||0.0001|TWO_SIDED|95.0|-1.02|-0.34||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 3||-0.34|-1.02|0.0001
72356530|NCT03192176|144229964|SUPERIORITY||LSMean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.18||0.0046|TWO_SIDED|95.0|-0.85|-0.16||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4||-0.16|-0.85|0.0046
72356531|NCT03192176|144229964|SUPERIORITY||LSMean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.18||0.0003|TWO_SIDED|95.0|-0.99|-0.29||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4||-0.29|-0.99|0.0003
72356532|NCT03192176|144229964|SUPERIORITY||LSMean difference|-0.8|STANDARD_ERROR_OF_MEAN|0.18|<|0.0001|TWO_SIDED|95.0|-1.14|-0.45||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4||-0.45|-1.14|<0.0001
72356533|NCT03192176|144229964|SUPERIORITY||LSMean difference|-1.1|STANDARD_ERROR_OF_MEAN|0.18|<|0.0001|TWO_SIDED|95.0|-1.14|-0.7||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4||-0.70|-1.14|<0.0001
72356534|NCT03192176|144229964|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.18||0.0209|TWO_SIDED|95.0|-0.77|-0.06||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4||-0.06|-0.77|0.0209
72356535|NCT03192176|144229964|SUPERIORITY||LSMean difference|-0.6|STANDARD_DEVIATION|0.18||0.0011|TWO_SIDED|95.0|-0.93|-0.24||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4||-0.24|-0.93|0.0011
72356536|NCT03192176|144229964|SUPERIORITY||LSMean difference|-0.7|STANDARD_ERROR_OF_MEAN|0.18|<|0.0001|TWO_SIDED|95.0|-1.07|-0.38||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4||-0.38|-1.07|<0.0001
72356537|NCT03192176|144229964|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.18||0.0956|TWO_SIDED|95.0|-0.67|0.05||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 5||0.05|-0.67|0.0956
72356538|NCT03192176|144229964|SUPERIORITY||LSMean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.19||0.005|TWO_SIDED|95.0|-0.89|-0.16||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 5||-0.16|-0.89|0.0050
72356539|NCT03192176|144229964|SUPERIORITY||LSMean difference|-0.8|STANDARD_ERROR_OF_MEAN|0.19|<|0.0001|TWO_SIDED|95.0|-1.18|-0.45||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 5||-0.45|-1.18|<0.0001
72356540|NCT03192176|144229964|SUPERIORITY||LSMean difference|-1.0|STANDARD_ERROR_OF_MEAN|0.19|<|0.0001|TWO_SIDED|95.0|-1.4|-0.65||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 5||-0.65|-1.40|<0.0001
72356541|NCT03192176|144229964|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.19||0.0915|TWO_SIDED|95.0|-0.69|0.05||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 5||0.05|-0.69|0.0915
72356542|NCT03192176|144229964|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.19||0.0378|TWO_SIDED|95.0|-0.75|-0.02||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 5||-0.02|-0.75|0.0378
72356543|NCT03192176|144229964|SUPERIORITY||LSMean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.19||0.0053|TWO_SIDED|95.0|-0.89|-0.16||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 5||-0.16|-0.89|0.0053
72356544|NCT03192176|144229964|SUPERIORITY||LSMean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.19||0.0614|TWO_SIDED|95.0|-0.83|-0.08||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 6||-0.08|-0.83|0.0614
72356545|NCT03192176|144229964|SUPERIORITY||LSMean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.19||0.004|TWO_SIDED|95.0|-0.92|-0.18||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 6||-0.18|-0.92|0.0040
72356546|NCT03192176|144229964|SUPERIORITY||LSMean difference|-1.0|STANDARD_ERROR_OF_MEAN|0.19|<|0.0001|TWO_SIDED|95.0|-1.33|-0.58||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 6||-0.58|-1.33|<0.0001
72356547|NCT03192176|144229964|SUPERIORITY||LSMean difference|-1.1|STANDARD_ERROR_OF_MEAN|0.19|<|0.0001|TWO_SIDED|95.0|-1.47|-0.71||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 6||-0.71|-1.47|<0.0001
72356548|NCT03192176|144229964|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.19||0.0967|TWO_SIDED|95.0|-0.7|0.06||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 6||0.06|-0.70|0.0967
72356549|NCT03192176|144229964|SUPERIORITY||LSMean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.19||0.0063|TWO_SIDED|95.0|-0.9|-0.15||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 6||-0.15|-0.90|0.0063
72356550|NCT03192176|144229964|SUPERIORITY||LSMean difference|-0.8|STANDARD_ERROR_OF_MEAN|0.19|<|0.0001|TWO_SIDED|95.0|-1.13|-0.38||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 6||-0.38|-1.13|<0.0001
72356551|NCT03192176|144229964|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.2||0.0632|TWO_SIDED|95.0|-0.75|0.02||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 7||0.02|-0.75|0.0632
72356552|NCT03192176|144229964|SUPERIORITY||LSMean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.2||0.002|TWO_SIDED|95.0|-1.0|-0.23||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 7||-0.23|-1.00|0.0020
72356553|NCT03192176|144229964|SUPERIORITY||LSMean difference|-0.9|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001|TWO_SIDED|95.0|-1.29|-0.51||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 7||-0.51|-1.29|<0.0001
72356554|NCT03192176|144229964|SUPERIORITY||LSMean difference|-1.1|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001|TWO_SIDED|95.0|-1.48|-0.69||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 7||-0.69|-1.48|<0.0001
72356555|NCT03192176|144229964|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.2||0.0308|TWO_SIDED|95.0|-0.82|-0.04||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 7||-0.04|-0.82|0.0308
72356556|NCT03192176|144229964|SUPERIORITY||LSMean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.2||0.0105|TWO_SIDED|95.0|-0.89|-0.12||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 7||-0.12|-0.89|0.0105
72356557|NCT03192176|144229964|SUPERIORITY||LSMean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.2||0.001|TWO_SIDED|95.0|-1.03|-0.26||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 7||-0.26|-1.03|0.0010
72356558|NCT03192176|144229964|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.2||0.1469|TWO_SIDED|95.0|-0.69|0.11||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8||0.11|-0.69|0.1469
72356559|NCT03192176|144229964|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.2||0.0315|TWO_SIDED|95.0|-0.84|-0.04||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8||-0.04|-0.84|0.0315
72356560|NCT03192176|144229964|SUPERIORITY||LSMean difference|-0.8|STANDARD_ERROR_OF_MEAN|0.21||0.0002|TWO_SIDED|95.0|-1.18|-0.38||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8||-0.38|-1.18|0.0002
72356561|NCT03192176|144229964|SUPERIORITY||LSMean difference|-0.8|STANDARD_ERROR_OF_MEAN|0.21|<|0.0001|TWO_SIDED|95.0|-1.26|-0.43||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8||-0.43|-1.26|<0.0001
72356562|NCT03192176|144229964|SUPERIORITY||LSMean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.21||0.4494|TWO_SIDED|95.0|-0.56|0.25||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8||0.25|-0.56|0.4494
72356563|NCT03192176|144229964|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.2||0.0595|TWO_SIDED|95.0|-0.79|0.02||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8||0.02|-0.79|0.0595
72356564|NCT03192176|144229964|SUPERIORITY||LSMean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.2||0.0065|TWO_SIDED|95.0|-0.96|-0.16||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8||-0.16|-0.96|0.0065
72356565|NCT03192176|144229964|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.2||0.0745|TWO_SIDED|95.0|-0.77|0.04||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 9||0.04|-0.77|0.0745
72356566|NCT03192176|144229964|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.21||0.054|TWO_SIDED|95.0|-0.8|0.01||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 9||0.01|-0.80|0.0540
72356567|NCT03192176|144229964|SUPERIORITY||LSMean difference|-0.8|STANDARD_ERROR_OF_MEAN|0.21||0.0001|TWO_SIDED|95.0|-1.22|-0.41||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 9||-0.41|-1.22|0.0001
72356568|NCT03192176|144229964|SUPERIORITY||LSMean difference|-0.8|STANDARD_ERROR_OF_MEAN|0.21|<|0.0001|TWO_SIDED|95.0|-1.26|-0.43||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 9||-0.43|-1.26|<0.0001
72356569|NCT03192176|144229964|SUPERIORITY||LSMean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.21||0.5317|TWO_SIDED|95.0|-0.54|0.28||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 9||0.28|-0.54|0.5317
72356570|NCT03192176|144229964|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.21||0.0424|TWO_SIDED|95.0|-0.83|-0.01||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 9||-0.01|-0.83|0.0424
72356571|NCT03192176|144229964|SUPERIORITY||LSMean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.21||0.0134|TWO_SIDED|95.0|-0.91|-0.11||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 9||-0.11|-0.91|0.0134
72356572|NCT03192176|144229964|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.2||0.03|TWO_SIDED|95.0|-0.84|-0.04||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 10||-0.04|-0.84|0.0300
72356573|NCT03192176|144229964|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.2||0.0605|TWO_SIDED|95.0|-0.78|0.02||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 10||0.02|-0.78|0.0605
72356574|NCT03192176|144229964|SUPERIORITY||LSMean difference|-0.8|STANDARD_ERROR_OF_MEAN|0.2||0.0001|TWO_SIDED|95.0|-1.2|-0.4||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 10||-0.40|-1.20|0.0001
72356575|NCT03192176|144229964|SUPERIORITY||LSMean difference|-1.0|STANDARD_ERROR_OF_MEAN|0.21|<|0.0001|TWO_SIDED|95.0|-1.38|-0.56||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 10||-0.56|-1.38|<0.0001
72356576|NCT03192176|144229964|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.21||0.1848|TWO_SIDED|95.0|-0.68|0.13||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Wek 10||0.13|-0.68|0.1848
72356577|NCT03192176|144229964|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.2||0.0321|TWO_SIDED|95.0|-0.84|-0.04||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 10||-0.04|-0.84|0.0321
72356578|NCT03192176|144229964|SUPERIORITY||LSMean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.2||0.0025|TWO_SIDED|95.0|-1.01|-0.22||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 10||-0.22|-1.01|0.0025
72356579|NCT03192176|144229964|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.2||0.0441|TWO_SIDED|95.0|-0.81|-0.01||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 11||-0.01|-0.81|0.0441
72356580|NCT03192176|144229964|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.2||0.0422|TWO_SIDED|95.0|-0.82|-0.01||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 11||-0.01|-0.82|0.0422
72356581|NCT03192176|144229964|SUPERIORITY||LSMean difference|-0.9|STANDARD_ERROR_OF_MEAN|0.21|<|0.0001|TWO_SIDED|95.0|-1.27|-0.45||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 11||-0.45|-1.27|<0.0001
72356582|NCT03192176|144229964|SUPERIORITY||LSMean difference|-1.0|STANDARD_ERROR_OF_MEAN|0.21|<|0.0001|TWO_SIDED|95.0|-1.44|-0.62||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 11||-0.62|-1.44|<0.0001
72356583|NCT03192176|144229964|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.21||0.1464|TWO_SIDED|95.0|-0.71|0.11||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 11||0.11|-0.71|0.1464
72356584|NCT03192176|144229964|SUPERIORITY||LSMean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.21||0.0144|TWO_SIDED|95.0|-0.91|-0.1||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 11||-0.10|-0.91|0.0144
72356585|NCT03192176|144229964|SUPERIORITY||LSMean difference|-0.7|STANDARD_ERROR_OF_MEAN|0.2||0.0013|TWO_SIDED|95.0|-1.06|-0.26||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 11||-0.26|-1.06|0.0013
72356586|NCT03192176|144229964|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.21||0.0596|TWO_SIDED|95.0|-0.8|0.02||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12||0.02|-0.80|0.0596
72356587|NCT03192176|144229964|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.21||0.036|TWO_SIDED|95.0|-0.85|-0.03||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12||-0.03|-0.85|0.0360
72356588|NCT03192176|144229964|SUPERIORITY||LSMean difference|-0.7|STANDARD_ERROR_OF_MEAN|0.21||0.0006|TWO_SIDED|95.0|-1.15|-0.32||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12||-0.32|-1.15|0.0006
72356589|NCT03192176|144229964|SUPERIORITY||LSMean difference|-0.8|STANDARD_ERROR_OF_MEAN|0.21||0.0002|TWO_SIDED|95.0|-1.23|-0.39||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12||-0.39|-1.23|0.0002
72356590|NCT03192176|144229964|SUPERIORITY||LSMean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.21||0.3227|TWO_SIDED|95.0|-0.62|0.21||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12||0.21|-0.62|0.3227
72356591|NCT03192176|144229964|SUPERIORITY||LSMean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.21||0.022|TWO_SIDED|95.0|-0.89|-0.07||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12||-0.07|-0.89|0.0220
72356592|NCT03192176|144229964|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.21||0.038|TWO_SIDED|95.0|-0.84|-0.02||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12||-0.02|-0.84|0.0380
72356593|NCT03192176|144229964|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.13||0.0067|TWO_SIDED|95.0|-0.6|-0.1||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 13||-0.10|-0.60|0.0067
72356594|NCT03192176|144229964|SUPERIORITY||LSMean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.13||0.1227|TWO_SIDED|95.0|-0.45|0.05||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMMRM|||Week 13||0.05|-0.45|0.1227
72356595|NCT03192176|144229964|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.13||0.0208|TWO_SIDED|95.0|-0.57|-0.05||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 13||-0.05|-0.57|0.0208
72356596|NCT03192176|144229964|SUPERIORITY||LSMean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.13||0.2396|TWO_SIDED|95.0|-0.41|0.1||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|LSMean difference|||Week 13||0.10|-0.41|0.2396
72356597|NCT03192176|144229964|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.13||0.0022|TWO_SIDED|95.0|-0.67|-0.15||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 13||-0.15|-0.67|0.0022
72356598|NCT03192176|144229964|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.13||0.0479|TWO_SIDED|95.0|-0.53|0.0||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 13||-0.00|-0.53|0.0479
72356599|NCT03192176|144229964|SUPERIORITY||LSMean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.13||0.4152|TWO_SIDED|95.0|-0.35|0.15||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 13||0.15|-0.35|0.4152
72356600|NCT03192176|144229964|SUPERIORITY||LSMean differencce|-0.3|STANDARD_ERROR_OF_MEAN|0.12||0.0262|TWO_SIDED|95.0|-0.52|-0.03||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 14||-0.03|-0.52|0.0262
72356601|NCT03192176|144229964|SUPERIORITY||LSMean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.12||0.121|TWO_SIDED|95.0|-0.43|0.05||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 14||0.05|-0.43|0.1210
72356602|NCT03192176|144229964|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.13||0.0369|TWO_SIDED|95.0|-0.52|-0.02||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 14||-0.02|-0.52|0.0369
72356603|NCT03192176|144229964|SUPERIORITY||LSMean differencce|-0.1|STANDARD_ERROR_OF_MEAN|0.13||0.5855|TWO_SIDED|95.0|-0.32|0.18||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 14||0.18|-0.32|0.5855
72356604|NCT03192176|144229964|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.13||0.0041|TWO_SIDED|95.0|-0.62|-0.12||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 14||-0.12|-0.62|0.0041
72356605|NCT03192176|144229964|SUPERIORITY||LSMean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.13||0.0614|TWO_SIDED|95.0|-0.5|0.01||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 14||0.01|-0.50|0.0614
72356606|NCT03192176|144229964|SUPERIORITY||LSMean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.12||0.3391|TWO_SIDED|95.0|-0.36|0.12||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 14||0.12|-0.36|0.3391
72356607|NCT03192176|144229964|SUPERIORITY||LSMean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.12||0.0515|TWO_SIDED|95.0|-0.49|0.0||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15||0.00|-0.49|0.0515
72356608|NCT03192176|144229964|SUPERIORITY||LSMean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.12||0.0667|TWO_SIDED|95.0|-0.47|0.02||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15||0.02|-0.47|0.0667
72356609|NCT03192176|144229964|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.13||0.0047|TWO_SIDED|95.0|-0.63|-0.12||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15||-0.12|-0.63|0.0047
72356610|NCT03192176|144229964|SUPERIORITY||LSMean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.13||0.513|TWO_SIDED|95.0|-0.34|0.17||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15||0.17|-0.34|0.5130
72356611|NCT03192176|144229964|SUPERIORITY||LSMean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.13||0.0002|TWO_SIDED|95.0|-0.75|-0.23||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15||-0.23|-0.75|0.0002
72356612|NCT03192176|144229964|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.13||0.0126|TWO_SIDED|95.0|-0.6|-0.07||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15||-0.07|-0.60|0.0126
72356613|NCT03192176|144229964|SUPERIORITY||LSMean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.12||0.3507|TWO_SIDED|95.0|-0.36|0.13||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15||0.13|-0.36|0.3507
72356614|NCT03192176|144229965|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.13||0.0098|TWO_SIDED|95.0|-0.6|-0.08||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 1||-0.08|-0.60|0.0098
72356615|NCT03192176|144229965|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.13||0.0048|TWO_SIDED|95.0|-0.63|-0.11||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 1||-0.11|-0.63|0.0048
72356616|NCT03192176|144229965|SUPERIORITY||LSMean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-0.8|-0.28||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 1||-0.28|-0.80|<0.0001
72356617|NCT03192176|144229965|SUPERIORITY||LSMean difference|-0.7|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-1.0|-0.47||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 1||-0.47|-1.00|<0.0001
72356618|NCT03192176|144229965|SUPERIORITY||LSMean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.12||0.6761|TWO_SIDED|95.0|-0.32|0.21||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 1||0.21|-0.32|0.6761
72356619|NCT03192176|144229965|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.13||0.0188|TWO_SIDED|95.0|-0.57|-0.05||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 1||-0.05|-0.57|0.0188
72356620|NCT03192176|144229965|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.13||0.0067|TWO_SIDED|95.0|-0.61|-0.1||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 1||-0.10|-0.61|0.0067
72356621|NCT03192176|144229965|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.17||0.0335|TWO_SIDED|95.0|-0.68|-0.03||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 2||-0.03|-0.68|0.0335
72356622|NCT03192176|144229965|SUPERIORITY||LSMean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.17||0.0007|TWO_SIDED|95.0|-0.91|-0.25||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 2||-0.25|-0.91|0.0007
72356623|NCT03192176|144229965|SUPERIORITY||LSMean differencce|-0.8|STANDARD_ERROR_OF_MEAN|0.17|<|0.0001|TWO_SIDED|95.0|-1.14|-0.48||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 2||-0.48|-1.14|<0.0001
72356624|NCT03192176|144229965|SUPERIORITY||LSMean difference|-1.1|STANDARD_ERROR_OF_MEAN|0.17|<|0.0001|TWO_SIDED|95.0|-1.41|-0.74||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 2||-0.74|-1.41|<0.0001
72356625|NCT03192176|144229965|SUPERIORITY||LSMean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.17||0.3227|TWO_SIDED|95.0|-0.5|0.17||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 2||0.17|-0.50|0.3227
72356626|NCT03192176|144229965|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.17||0.0085|TWO_SIDED|95.0|-0.77|-0.11||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 2||-0.11|-0.77|0.0085
72356627|NCT03192176|144229965|SUPERIORITY||LSMean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.17||0.0002|TWO_SIDED|95.0|-0.95|-0.3||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 2||-0.30|-0.95|0.0002
72356628|NCT03192176|144229965|SUPERIORITY||LSMean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.19||0.0102|TWO_SIDED|95.0|-0.87|-0.12||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 3||-0.12|-0.87|0.0102
72356629|NCT03192176|144229965|SUPERIORITY||LSMean difference|-0.8|STANDARD_ERROR_OF_MEAN|0.19|<|0.0001|TWO_SIDED|95.0|-1.15|-0.39||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 3||-0.39|-1.15|<0.0001
72356630|NCT03192176|144229965|SUPERIORITY||LSMean difference|-0.9|STANDARD_ERROR_OF_MEAN|0.19|<|0.0001|TWO_SIDED|95.0|-1.29|-0.54||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 3||-0.54|-1.29|<0.0001
72356631|NCT03192176|144229965|SUPERIORITY||LSMean difference|-1.1|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001|TWO_SIDED|95.0|-1.46|-0.68||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 3||-0.68|-1.46|<0.0001
72356632|NCT03192176|144229965|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.2||0.074|TWO_SIDED|95.0|-0.73|0.03||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 3||0.03|-0.73|0.0740
72356633|NCT03192176|144229965|SUPERIORITY||LSMean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.19||0.0024|TWO_SIDED|95.0|-0.97|-0.21||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 3||-0.21|-0.97|0.0024
72356634|NCT03192176|144229965|SUPERIORITY||LSMean difference|-0.8|STANDARD_ERROR_OF_MEAN|0.19|<|0.0001|TWO_SIDED|95.0|-1.17|-0.41||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 3||-0.41|-1.17|<0.0001
72356635|NCT03192176|144229965|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.2||0.1197|TWO_SIDED|95.0|-0.72|0.08||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 5||0.08|-0.72|0.1197
72356636|NCT03192176|144229965|SUPERIORITY||LSMean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.2||0.0046|TWO_SIDED|95.0|-0.98|-0.18||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 5||-0.18|-0.98|0.0046
72356637|NCT03192176|144229965|SUPERIORITY||LSMean difference|-0.9|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001|TWO_SIDED|95.0|-1.28|-0.47||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 5||-0.47|-1.28|<0.0001
72356638|NCT03192176|144229965|SUPERIORITY||LSMean difference|-1.1|STANDARD_ERROR_OF_MEAN|0.21|<|0.0001|TWO_SIDED|95.0|-1.51|-0.69||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 5||-0.69|-1.51|<0.0001
72356639|NCT03192176|144229965|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.21||0.0553|TWO_SIDED|95.0|-0.8|0.01||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 5||0.01|-0.80|0.0553
72356640|NCT03192176|144229965|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.2||0.0823|TWO_SIDED|95.0|-0.76|0.05||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 5||0.05|-0.76|0.0823
72356641|NCT03192176|144229965|SUPERIORITY||LSMean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.2||0.006|TWO_SIDED|95.0|-0.96|-0.16||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 5||-0.16|-0.96|0.0060
72356642|NCT03192176|144229965|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.21||0.0374|TWO_SIDED|95.0|-0.83|-0.03||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 6||-0.03|-0.83|0.0374
72356643|NCT03192176|144229965|SUPERIORITY||LSMean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.21||0.0042|TWO_SIDED|95.0|-1.0|-0.19||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 6||-0.19|-1.00|0.0042
72356644|NCT03192176|144229965|SUPERIORITY||LSMean difference|-1.0|STANDARD_ERROR_OF_MEAN|0.21|<|0.0001|TWO_SIDED|95.0|-1.38|-0.56||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 6||-0.56|-1.38|<0.0001
72356645|NCT03192176|144229965|SUPERIORITY||LSMean difference|-1.1|STANDARD_ERROR_OF_MEAN|0.21|<|0.0001|TWO_SIDED|95.0|-1.54|-0.71||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 6||-0.71|-1.54|<0.0001
72356646|NCT03192176|144229965|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.21||0.071|TWO_SIDED|95.0|-0.79|0.03||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 6||0.03|-0.79|0.0710
72356647|NCT03192176|144229965|SUPERIORITY||LSMean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.21||0.016|TWO_SIDED|95.0|-0.91|-0.09||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 6||-0.09|-0.91|0.0160
72356648|NCT03192176|144229965|SUPERIORITY||LSMean difference|-0.7|STANDARD_ERROR_OF_MEAN|0.21||0.0003|TWO_SIDED|95.0|-1.15|-0.34||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 6||-0.34|-1.15|0.0003
72356649|NCT03192176|144229965|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.21||0.1013|TWO_SIDED|95.0|-0.76|0.07||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 7||0.07|-0.76|0.1013
72356650|NCT03192176|144229965|SUPERIORITY||LSMean difference|-0.7|STANDARD_ERROR_OF_MEAN|0.21||0.0011|TWO_SIDED|95.0|-1.11|-0.28||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 7||-0.28|-1.11|0.0011
72356651|NCT03192176|144229965|SUPERIORITY||LSMean difference|-0.9|STANDARD_ERROR_OF_MEAN|0.21|<|0.0001|TWO_SIDED|95.0|-1.36|-0.53||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 7||-0.53|-1.36|<0.0001
72356652|NCT03192176|144229965|SUPERIORITY||LSMean difference|-1.1|STANDARD_ERROR_OF_MEAN|0.22|<|0.0001|TWO_SIDED|95.0|-1.57|-0.72||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 7||-0.72|-1.57|<0.0001
72356653|NCT03192176|144229965|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.21||0.0476|TWO_SIDED|95.0|-0.85|0.0||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 7||-0.00|-0.85|0.0476
72356654|NCT03192176|144229965|SUPERIORITY||LSMean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.21||0.022|TWO_SIDED|95.0|-0.9|-0.07||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 7||-0.07|-0.90|0.0220
72356655|NCT03192176|144229965|SUPERIORITY||LSMean difference|-0.7|STANDARD_ERROR_OF_MEAN|0.21||0.0019|TWO_SIDED|95.0|-1.07|-0.24||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 7||-0.24|-1.07|0.0019
72356656|NCT03192176|144229965|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.22||0.1457|TWO_SIDED|95.0|-0.74|0.11||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8||0.11|-0.74|0.1457
72356657|NCT03192176|144229965|SUPERIORITY||LSMean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.22||0.0284|TWO_SIDED|95.0|-0.91|-0.05||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8||-0.05|-0.91|0.0284
72356658|NCT03192176|144229965|SUPERIORITY||LSMean difference|-0.8|STANDARD_ERROR_OF_MEAN|0.22||0.0002|TWO_SIDED|95.0|-1.26|-0.39||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8||-0.39|-1.26|0.0002
72356659|NCT03192176|144229965|SUPERIORITY||LSMean difference|-0.9|STANDARD_ERROR_OF_MEAN|0.22|<|0.0001|TWO_SIDED|95.0|-1.36|-0.48||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8||-0.48|-1.36|<0.0001
72356660|NCT03192176|144229965|SUPERIORITY||LSMean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.22||0.4223|TWO_SIDED|95.0|-0.61|0.26||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8||0.26|-0.61|0.4223
72356661|NCT03192176|144229965|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.22||0.0442|TWO_SIDED|95.0|-0.87|-0.01||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8||-0.01|-0.87|0.0442
72356662|NCT03192176|144229965|SUPERIORITY||LSMean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.22||0.0071|TWO_SIDED|95.0|-1.02|-0.16||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8||-0.16|-1.02|0.0071
72356663|NCT03192176|144229965|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.22||0.0823|TWO_SIDED|95.0|-0.8|0.05||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 9||0.05|-0.80|0.0823
72356664|NCT03192176|144229965|SUPERIORITY||LSMean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.22||0.0336|TWO_SIDED|95.0|-0.89|-0.04||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 9||-0.04|-0.89|0.0336
72356665|NCT03192176|144229965|SUPERIORITY||LSMean difference|-0.9|STANDARD_ERROR_OF_MEAN|0.22|<|0.0001|TWO_SIDED|95.0|-1.32|-0.46||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 9||-0.46|-1.32|<0.0001
72356666|NCT03192176|144229965|SUPERIORITY||LSMean difference|-0.9|STANDARD_ERROR_OF_MEAN|0.22|<|0.0001|TWO_SIDED|95.0|-1.34|-0.47||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 9||-0.47|-1.34|<0.0001
72356667|NCT03192176|144229965|SUPERIORITY||LSMean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.22||0.4819|TWO_SIDED|95.0|-0.59|0.28||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 9||0.28|-0.59|0.4819
72356668|NCT03192176|144229965|SUPERIORITY||LSMean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.22||0.0371|TWO_SIDED|95.0|-0.88|-0.03||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 9||-0.03|-0.88|0.0371
72356669|NCT03192176|144229965|SUPERIORITY||LSMean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.22||0.0121|TWO_SIDED|95.0|-0.97|-0.12||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 9||-0.12|-0.97|0.0121
72356670|NCT03192176|144229965|SUPERIORITY||LSMean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.21||0.0281|TWO_SIDED|95.0|-0.89|-0.05||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 10||-0.05|-0.89|0.0281
72356671|NCT03192176|144229965|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.22||0.0436|TWO_SIDED|95.0|-0.86|-0.01||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 10||-0.01|-0.86|0.0436
72356672|NCT03192176|144229965|SUPERIORITY||LSMean difference|-0.9|STANDARD_ERROR_OF_MEAN|0.22|<|0.0001|TWO_SIDED|95.0|-1.34|-0.49||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 10||-0.49|-1.34|<0.0001
72356673|NCT03192176|144229965|SUPERIORITY||LSMean difference|-1.0|STANDARD_ERROR_OF_MEAN|0.22|<|0.0001|TWO_SIDED|95.0|-1.47|-0.6||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 10||-0.60|-1.47|<0.0001
72356674|NCT03192176|144229965|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.22||0.1488|TWO_SIDED|95.0|-0.75|0.11||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Wek 10||0.11|-0.75|0.1488
72356675|NCT03192176|144229965|SUPERIORITY||LSMean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.22||0.0251|TWO_SIDED|95.0|-0.91|-0.06||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 10||-0.06|-0.91|0.0251
72356676|NCT03192176|144229965|SUPERIORITY||LSMean difference|-0.7|STANDARD_ERROR_OF_MEAN|0.22||0.0027|TWO_SIDED|95.0|-1.08|-0.23||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 10||-0.23|-1.08|0.0027
72356677|NCT03192176|144229965|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.22||0.1053|TWO_SIDED|95.0|-0.77|0.07||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 11||0.07|-0.77|0.1053
72356678|NCT03192176|144229965|SUPERIORITY||LSMean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.22||0.0304|TWO_SIDED|95.0|-0.9|-0.04||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 11||-0.04|-0.90|0.0304
72356679|NCT03192176|144229965|SUPERIORITY||LSMean difference|-0.9|STANDARD_ERROR_OF_MEAN|0.22|<|0.0001|TWO_SIDED|95.0|-1.33|-0.43||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 11||-0.43|-1.33|<0.0001
72356680|NCT03192176|144229965|SUPERIORITY||LSMean difference|-1.1|STANDARD_ERROR_OF_MEAN|0.22|<|0.0001|TWO_SIDED|95.0|-1.49|-0.61||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 11||-0.61|-1.49|<0.0001
72356681|NCT03192176|144229965|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.22||0.0873|TWO_SIDED|95.0|-0.81|0.06||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 11||0.06|-0.81|0.0873
72356682|NCT03192176|144229965|SUPERIORITY||LSMean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.22||0.0124|TWO_SIDED|95.0|-0.97|-0.12||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 11||-0.12|-0.97|0.0124
72356683|NCT03192176|144229965|SUPERIORITY||LSMean difference|-0.7|STANDARD_ERROR_OF_MEAN|0.22||0.0014|TWO_SIDED|95.0|-1.12|-0.27||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 11||-0.27|-1.12|0.0014
72356684|NCT03192176|144229965|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.17||0.0479|TWO_SIDED|95.0|-0.68|0.0||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 13||-0.00|-0.68|0.0479
72356685|NCT03192176|144229965|SUPERIORITY||LSMean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.17||0.2342|TWO_SIDED|95.0|-0.54|0.13||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMMRM|||Week 13||0.13|-0.54|0.2342
72356686|NCT03192176|144229965|SUPERIORITY||LSMean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.18||0.007|TWO_SIDED|95.0|-0.84|-0.13||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 13||-0.13|-0.84|0.0070
72356687|NCT03192176|144229965|SUPERIORITY||LSMean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.18||0.4291|TWO_SIDED|95.0|-0.49|0.21||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|LSMean difference|||Week 13||0.21|-0.49|0.4291
72356688|NCT03192176|144229965|SUPERIORITY||LSMean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.18||0.0076|TWO_SIDED|95.0|-0.83|-0.13||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 13||-0.13|-0.83|0.0076
72356689|NCT03192176|144229965|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.18||0.1506|TWO_SIDED|95.0|-0.62|0.1||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 13||0.10|-0.62|0.1506
72356690|NCT03192176|144229965|SUPERIORITY||LSMean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.17||0.5479|TWO_SIDED|95.0|-0.44|0.24||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 13||0.24|-0.44|0.5479
72356691|NCT03192176|144229965|SUPERIORITY||LSMean differencce|-0.2|STANDARD_ERROR_OF_MEAN|0.17||0.1427|TWO_SIDED|95.0|-0.57|0.08||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 14||0.08|-0.57|0.1427
72356692|NCT03192176|144229965|SUPERIORITY||LSMean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.16||0.1498|TWO_SIDED|95.0|-0.56|0.09||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 14||0.09|-0.56|0.1498
72356693|NCT03192176|144229965|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.17||0.0103|TWO_SIDED|95.0|-0.79|-0.11||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 14||-0.11|-0.79|0.0103
72356694|NCT03192176|144229965|SUPERIORITY||LSMean differencce|0.0|STANDARD_ERROR_OF_MEAN|0.17||0.8984|TWO_SIDED|95.0|-0.36|0.32||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 14||0.32|-0.36|0.8984
72356695|NCT03192176|144229965|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.17||0.0095|TWO_SIDED|95.0|-0.79|-0.11||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 14||-0.11|-0.79|0.0095
72356696|NCT03192176|144229965|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.17||0.137|TWO_SIDED|95.0|-0.6|0.08||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 14||0.08|-0.60|0.1370
72356697|NCT03192176|144229965|SUPERIORITY||LSMean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.17||0.4223|TWO_SIDED|95.0|-0.46|0.19||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 14||0.19|-0.46|0.4223
72356698|NCT03192176|144229965|SUPERIORITY||LSMean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.17||0.3265|TWO_SIDED|95.0|-0.5|0.17||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15||0.17|-0.50|0.3265
72356699|NCT03192176|144229965|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.17||0.0852|TWO_SIDED|95.0|-0.62|0.04||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15||0.04|-0.62|0.0852
72356700|NCT03192176|144229965|SUPERIORITY||LSMean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.18||0.0021|TWO_SIDED|95.0|-0.91|-0.21||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15||-0.21|-0.91|0.0021
72356701|NCT03192176|144229965|SUPERIORITY||LSMean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.18||0.5717|TWO_SIDED|95.0|-0.45|0.25||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15||0.25|-0.45|0.5717
72356702|NCT03192176|144229965|SUPERIORITY||LSMean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.18||0.0084|TWO_SIDED|95.0|-0.82|-0.12||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15||-0.12|-0.82|0.0084
72356703|NCT03192176|144229965|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.18||0.0277|TWO_SIDED|95.0|-0.75|-0.04||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15||-0.04|-0.75|0.0277
72356704|NCT03192176|144229965|SUPERIORITY||LSMean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.17||0.4627|TWO_SIDED|95.0|-0.46|0.21||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15||0.21|-0.46|0.4627
72356705|NCT03192176|144229966|SUPERIORITY||LSMean difference|-4.8|STANDARD_ERROR_OF_MEAN|1.94||0.0142|TWO_SIDED|95.0|-8.62|-0.97||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 1||-0.97|-8.62|0.0142
72356706|NCT03192176|144229966|SUPERIORITY||LSMean difference|-7.9|STANDARD_ERROR_OF_MEAN|1.95|<|0.0001|TWO_SIDED|95.0|-11.73|-4.05||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 1||-4.05|-11.73|<0.0001
72356707|NCT03192176|144229966|SUPERIORITY||LSMean difference|-9.1|STANDARD_ERROR_OF_MEAN|1.95|<|0.0001|TWO_SIDED|95.0|-12.98|-5.31||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 1||-5.31|-12.98|<0.0001
72356708|NCT03192176|144229966|SUPERIORITY||LSMean difference|-10.5|STANDARD_ERROR_OF_MEAN|1.98|<|0.0001|TWO_SIDED|95.0|-14.39|-6.61||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 1||-6.61|-14.39|<0.0001
72356709|NCT03192176|144229966|SUPERIORITY||LSMean difference|-3.5|STANDARD_ERROR_OF_MEAN|1.98||0.0819|TWO_SIDED|95.0|-7.36|0.44||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 1||0.44|-7.36|0.0819
72356710|NCT03192176|144229966|SUPERIORITY||LSMean difference|-6.9|STANDARD_ERROR_OF_MEAN|1.95||0.0004|TWO_SIDED|95.0|-10.78|-3.09||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 1||-3.09|-10.78|0.0004
72356711|NCT03192176|144229966|SUPERIORITY||LSMean difference|-6.9|STANDARD_ERROR_OF_MEAN|1.94||0.0005|TWO_SIDED|95.0|-10.69|-3.05||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 1||-3.05|-10.69|0.0005
72356712|NCT03192176|144229966|SUPERIORITY||LSMean difference|-4.1|STANDARD_ERROR_OF_MEAN|1.98||0.038|TWO_SIDED|95.0|-8.01|-0.23||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 2||-0.23|-8.01|0.0380
72356713|NCT03192176|144229966|SUPERIORITY||LSMean difference|-7.6|STANDARD_ERROR_OF_MEAN|1.99||0.0002|TWO_SIDED|95.0|-11.46|-3.64||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 2||-3.64|-11.46|0.0002
72356714|NCT03192176|144229966|SUPERIORITY||LSMean differencce|-8.1|STANDARD_ERROR_OF_MEAN|1.98|<|0.0001|TWO_SIDED|95.0|-11.96|-4.17||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 2||-4.17|-11.96|<0.0001
72356715|NCT03192176|144229966|SUPERIORITY||LSMean difference|-9.2|STANDARD_ERROR_OF_MEAN|2.01|<|0.0001|TWO_SIDED|95.0|-13.17|-5.25||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 2||-5.25|-13.17|<0.0001
72356716|NCT03192176|144229966|SUPERIORITY||LSMean difference|-4.6|STANDARD_ERROR_OF_MEAN|2.02||0.0245|TWO_SIDED|95.0|-8.52|-0.59||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 2||-0.59|-8.52|0.0245
72356717|NCT03192176|144229966|SUPERIORITY||LSMean difference|-5.9|STANDARD_ERROR_OF_MEAN|1.99||0.0031|TWO_SIDED|95.0|-9.83|-2.01||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 2||-2.01|-9.83|0.0031
72356718|NCT03192176|144229966|SUPERIORITY||LSMean difference|-5.6|STANDARD_ERROR_OF_MEAN|1.98||0.0046|TWO_SIDED|95.0|-9.53|-1.75||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 2||-1.75|-9.53|0.0046
72356719|NCT03192176|144229966|SUPERIORITY||LSMean difference|-5.6|STANDARD_ERROR_OF_MEAN|2.04||0.0064|TWO_SIDED|95.0|-9.61|-1.59||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 3||-1.59|-9.61|0.0064
72356720|NCT03192176|144229966|SUPERIORITY||LSMean difference|-8.7|STANDARD_ERROR_OF_MEAN|2.05|<|0.0001|TWO_SIDED|95.0|-12.72|-4.65||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 3||-4.65|-12.72|<0.0001
72356721|NCT03192176|144229966|SUPERIORITY||LSMean difference|-8.8|STANDARD_ERROR_OF_MEAN|2.04|<|0.0001|TWO_SIDED|95.0|-12.78|-4.75||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 3||-4.75|-12.78|<0.0001
72356722|NCT03192176|144229966|SUPERIORITY||LSMean difference|-10.2|STANDARD_ERROR_OF_MEAN|2.08|<|0.0001|TWO_SIDED|95.0|-14.27|-6.09||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 3||-6.09|-14.27|<0.0001
72356723|NCT03192176|144229966|SUPERIORITY||LSMean difference|-6.4|STANDARD_ERROR_OF_MEAN|2.08||0.0021|TWO_SIDED|95.0|-10.54|-2.36||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 3||-2.36|-10.54|0.0021
72356724|NCT03192176|144229966|SUPERIORITY||LSMean difference|-7.7|STANDARD_ERROR_OF_MEAN|2.05||0.0002|TWO_SIDED|95.0|-11.71|-3.66||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 3||-3.66|-11.71|0.0002
72356725|NCT03192176|144229966|SUPERIORITY||LSMean difference|-7.0|STANDARD_ERROR_OF_MEAN|2.04||0.0007|TWO_SIDED|95.0|-10.96|-2.95||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 3||-2.95|-10.96|0.0007
72356726|NCT03192176|144229966|SUPERIORITY||LSMean difference|-5.5|STANDARD_ERROR_OF_MEAN|2.03||0.0075|TWO_SIDED|95.0|-9.46|-1.47||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4||-1.47|-9.46|0.0075
72356727|NCT03192176|144229966|SUPERIORITY||LSMean difference|-8.4|STANDARD_ERROR_OF_MEAN|2.04|<|0.0001|TWO_SIDED|95.0|-12.44|-4.42||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4||-4.42|-12.44|<0.0001
72356728|NCT03192176|144229966|SUPERIORITY||LSMean difference|-8.2|STANDARD_ERROR_OF_MEAN|2.03|<|0.0001|TWO_SIDED|95.0|-12.15|-4.16||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4||-4.16|-12.15|<0.0001
72356729|NCT03192176|144229966|SUPERIORITY||LSMean difference|-10.2|STANDARD_ERROR_OF_MEAN|2.07|<|0.0001|TWO_SIDED|95.0|-14.3|-6.16||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4||-6.16|-14.30|<0.0001
72356730|NCT03192176|144229966|SUPERIORITY||LSMean difference|-6.4|STANDARD_ERROR_OF_MEAN|2.06||0.0021|TWO_SIDED|95.0|-10.46|-2.34||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4||-2.34|-10.46|0.0021
72356731|NCT03192176|144229966|SUPERIORITY||LSMean difference|-8.3|STANDARD_ERROR_OF_MEAN|0.18|<|0.0001|TWO_SIDED|95.0|-12.25|-4.25||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4||-4.25|-12.25|<0.0001
72356732|NCT03192176|144229966|SUPERIORITY||LSMean difference|-7.6|STANDARD_ERROR_OF_MEAN|2.02||0.0002|TWO_SIDED|95.0|-11.58|-3.62||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4||-3.62|-11.58|0.0002
72356733|NCT03192176|144229966|SUPERIORITY||LSMean difference|-4.8|STANDARD_ERROR_OF_MEAN|1.92||0.0123|TWO_SIDED|95.0|-8.6|-1.05||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 5||-1.05|-8.60|0.0123
72356734|NCT03192176|144229966|SUPERIORITY||LSMean difference|-7.8|STANDARD_ERROR_OF_MEAN|1.92|<|0.0001|TWO_SIDED|95.0|-11.63|-4.07||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 5||-4.07|-11.63|<0.0001
72356735|NCT03192176|144229966|SUPERIORITY||LSMean difference|-8.0|STANDARD_ERROR_OF_MEAN|1.92|<|0.0001|TWO_SIDED|95.0|-11.8|-4.23||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 5||-4.23|-11.80|<0.0001
72356736|NCT03192176|144229966|SUPERIORITY||LSMean difference|-9.9|STANDARD_ERROR_OF_MEAN|1.95|<|0.0001|TWO_SIDED|95.0|-13.73|-6.03||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 5||-6.03|-13.73|<0.0001
72356737|NCT03192176|144229966|SUPERIORITY||LSMean difference|-6.3|STANDARD_ERROR_OF_MEAN|1.95||0.0013|TWO_SIDED|95.0|-10.13|-2.47||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 5||-2.47|-10.13|0.0013
72356738|NCT03192176|144229966|SUPERIORITY||LSMean difference|-7.2|STANDARD_ERROR_OF_MEAN|1.92||0.0002|TWO_SIDED|95.0|-10.97|-3.41||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 5||-3.41|-10.97|0.0002
72356739|NCT03192176|144229966|SUPERIORITY||LSMean difference|-6.7|STANDARD_ERROR_OF_MEAN|1.91||0.0006|TWO_SIDED|95.0|-10.41|-2.89||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 5||-2.89|-10.41|0.0006
72356740|NCT03192176|144229966|SUPERIORITY||LSMean difference|-4.8|STANDARD_ERROR_OF_MEAN|1.9||0.0119|TWO_SIDED|95.0|-8.54|-1.07||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 6||-1.07|-8.54|0.0119
72356741|NCT03192176|144229966|SUPERIORITY||LSMean difference|-6.8|STANDARD_ERROR_OF_MEAN|1.9||0.0004|TWO_SIDED|95.0|-10.58|-3.09||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 6||-3.09|-10.58|0.0004
72356742|NCT03192176|144229966|SUPERIORITY||LSMean difference|-7.8|STANDARD_ERROR_OF_MEAN|1.91|<|0.0001|TWO_SIDED|95.0|-11.57|-4.06||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 6||-4.06|-11.57|<0.0001
72356743|NCT03192176|144229966|SUPERIORITY||LSMean difference|-9.1|STANDARD_ERROR_OF_MEAN|1.94|<|0.0001|TWO_SIDED|95.0|-12.89|-5.27||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 6||-5.27|-12.89|<0.0001
72356744|NCT03192176|144229966|SUPERIORITY||LSMean difference|-5.4|STANDARD_ERROR_OF_MEAN|1.93||0.0057|TWO_SIDED|95.0|-9.18|-1.58||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 6||-1.58|-9.18|0.0057
72356745|NCT03192176|144229966|SUPERIORITY||LSMean difference|-6.7|STANDARD_ERROR_OF_MEAN|1.91||0.0006|TWO_SIDED|95.0|-10.4|-2.9||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 6||-2.90|-10.40|0.0006
72356746|NCT03192176|144229966|SUPERIORITY||LSMean difference|-6.5|STANDARD_ERROR_OF_MEAN|1.89||0.0006|TWO_SIDED|95.0|-10.27|-2.81||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 6||-2.81|-10.27|0.0006
72356747|NCT03192176|144229966|SUPERIORITY||LSMean difference|-4.5|STANDARD_ERROR_OF_MEAN|1.93||0.021|TWO_SIDED|95.0|-8.27|-0.68||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 7||-0.68|-8.27|0.0210
72356748|NCT03192176|144229966|SUPERIORITY||LSMean difference|-7.2|STANDARD_ERROR_OF_MEAN|1.93||0.0002|TWO_SIDED|95.0|-10.98|-3.38||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 7||-3.38|-10.98|0.0002
72356749|NCT03192176|144229966|SUPERIORITY||LSMean difference|-7.3|STANDARD_ERROR_OF_MEAN|1.94||0.0002|TWO_SIDED|95.0|-11.12|-3.49||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 7||-3.49|-11.12|0.0002
72356750|NCT03192176|144229966|SUPERIORITY||LSMean difference|-9.1|STANDARD_ERROR_OF_MEAN|1.97|<|0.0001|TWO_SIDED|95.0|-12.99|-5.25||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 7||-5.25|-12.99|<0.0001
72356751|NCT03192176|144229966|SUPERIORITY||LSMean difference|-5.6|STANDARD_ERROR_OF_MEAN|1.96||0.0047|TWO_SIDED|95.0|-9.45|-1.73||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 7||-1.73|-9.45|0.0047
72356752|NCT03192176|144229966|SUPERIORITY||LSMean difference|-6.5|STANDARD_ERROR_OF_MEAN|1.94||0.0009|TWO_SIDED|95.0|-10.29|-2.67||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 7||-2.67|-10.29|0.0009
72356753|NCT03192176|144229966|SUPERIORITY||LSMean difference|-6.5|STANDARD_ERROR_OF_MEAN|1.92||0.0008|TWO_SIDED|95.0|-10.28|-2.71||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 7||-2.71|-10.28|0.0008
72356754|NCT03192176|144229966|SUPERIORITY||LSMean difference|-3.3|STANDARD_ERROR_OF_MEAN|1.93||0.0889|TWO_SIDED|95.0|-7.1|0.51||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8||0.51|-7.10|0.0889
72356755|NCT03192176|144229966|SUPERIORITY||LSMean difference|-5.9|STANDARD_ERROR_OF_MEAN|1.94||0.0023|TWO_SIDED|95.0|-9.76|-2.13||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8||-2.13|-9.76|0.0023
72356756|NCT03192176|144229966|SUPERIORITY||LSMean difference|-6.5|STANDARD_ERROR_OF_MEAN|1.94||0.0009|TWO_SIDED|95.0|-10.36|-2.71||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8||-2.71|-10.36|0.0009
72356757|NCT03192176|144229966|SUPERIORITY||LSMean difference|-7.5|STANDARD_ERROR_OF_MEAN|1.98||0.0002|TWO_SIDED|95.0|-11.36|-3.58||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8||-3.58|-11.36|0.0002
72356758|NCT03192176|144229966|SUPERIORITY||LSMean difference|-4.4|STANDARD_ERROR_OF_MEAN|1.97||0.0255|TWO_SIDED|95.0|-8.3|-0.55||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8||-0.55|-8.30|0.0255
72356759|NCT03192176|144229966|SUPERIORITY||LSMean difference|-5.8|STANDARD_ERROR_OF_MEAN|1.94||0.0031|TWO_SIDED|95.0|-9.63|-1.98||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8||-1.98|-9.63|0.0031
72356760|NCT03192176|144229966|SUPERIORITY||LSMean difference|-5.7|STANDARD_ERROR_OF_MEAN|1.93||0.0037|TWO_SIDED|95.0|-9.45|-1.85||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8||-1.85|-9.45|0.0037
72356761|NCT03192176|144229966|SUPERIORITY||LSMean difference|-4.0|STANDARD_ERROR_OF_MEAN|1.84||0.0316|TWO_SIDED|95.0|-7.59|-0.35||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 9||-0.35|-7.59|0.0316
72356762|NCT03192176|144229966|SUPERIORITY||LSMean difference|-5.4|STANDARD_ERROR_OF_MEAN|1.84||0.0036|TWO_SIDED|95.0|-9.02|-1.78||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 9||-1.78|-9.02|0.0036
72356763|NCT03192176|144229966|SUPERIORITY||LSMean difference|-6.6|STANDARD_ERROR_OF_MEAN|1.85||0.0004|TWO_SIDED|95.0|-10.23|-2.94||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 9||-2.94|-10.23|0.0004
72356764|NCT03192176|144229966|SUPERIORITY||LSMean difference|-7.2|STANDARD_ERROR_OF_MEAN|1.88||0.0001|TWO_SIDED|95.0|-10.93|-3.54||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 9||-3.54|-10.93|0.0001
72356765|NCT03192176|144229966|SUPERIORITY||LSMean difference|-3.7|STANDARD_ERROR_OF_MEAN|1.87||0.0502|TWO_SIDED|95.0|-7.37|0.0||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 9||0.00|-7.37|0.0502
72356766|NCT03192176|144229966|SUPERIORITY||LSMean difference|-5.6|STANDARD_ERROR_OF_MEAN|1.85||0.0025|TWO_SIDED|95.0|-9.28|-1.99||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 9||-1.99|-9.28|0.0025
72356767|NCT03192176|144229966|SUPERIORITY||LSMean difference|-5.1|STANDARD_ERROR_OF_MEAN|1.84||0.0063|TWO_SIDED|95.0|-8.67|-1.44||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 9||-1.44|-8.67|0.0063
72356768|NCT03192176|144229966|SUPERIORITY||LSMean difference|-4.8|STANDARD_ERROR_OF_MEAN|1.9||0.0117|TWO_SIDED|95.0|-8.58|-1.08||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 10||-1.08|-8.58|0.0117
72356769|NCT03192176|144229966|SUPERIORITY||LSMean difference|-5.4|STANDARD_ERROR_OF_MEAN|1.91||0.0047|TWO_SIDED|95.0|-9.17|-1.67||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 10||-1.67|-9.17|0.0047
72356770|NCT03192176|144229966|SUPERIORITY||LSMean difference|-7.0|STANDARD_ERROR_OF_MEAN|1.92||0.0003|TWO_SIDED|95.0|-10.8|-3.23||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 10||-3.23|-10.80|0.0003
72356771|NCT03192176|144229966|SUPERIORITY||LSMean difference|-7.7|STANDARD_ERROR_OF_MEAN|1.94|<|0.0001|TWO_SIDED|95.0|-11.51|-3.86||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 10||-3.86|-11.51|<0.0001
72356772|NCT03192176|144229966|SUPERIORITY||LSMean difference|-5.2|STANDARD_ERROR_OF_MEAN|1.94||0.0083|TWO_SIDED|95.0|-8.97|-1.34||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Wek 10||-1.34|-8.97|0.0083
72356773|NCT03192176|144229966|SUPERIORITY||LSMean difference|-6.3|STANDARD_ERROR_OF_MEAN|1.92||0.0011|TWO_SIDED|95.0|-10.1|-2.56||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 10||-2.56|-10.10|0.0011
72356774|NCT03192176|144229966|SUPERIORITY||LSMean difference|-6.0|STANDARD_ERROR_OF_MEAN|1.9||0.0017|TWO_SIDED|95.0|-9.77|-2.29||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 10||-2.29|-9.77|0.0017
72356775|NCT03192176|144229966|SUPERIORITY||LSMean difference|-4.7|STANDARD_ERROR_OF_MEAN|1.86||0.0119|TWO_SIDED|95.0|-8.37|-1.05||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 11||-1.05|-8.37|0.0119
72356776|NCT03192176|144229966|SUPERIORITY||LSMean difference|-6.0|STANDARD_ERROR_OF_MEAN|1.86||0.0015|TWO_SIDED|95.0|-9.61|-2.29||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 11||-2.29|-9.61|0.0015
72356777|NCT03192176|144229966|SUPERIORITY||LSMean difference|-7.7|STANDARD_ERROR_OF_MEAN|1.88|<|0.0001|TWO_SIDED|95.0|-11.38|-3.99||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 11||-3.99|-11.38|<0.0001
72356778|NCT03192176|144229966|SUPERIORITY||LSMean difference|-7.6|STANDARD_ERROR_OF_MEAN|1.9|<|0.0001|TWO_SIDED|95.0|-11.33|-3.87||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 11||-3.87|-11.33|<0.0001
72356779|NCT03192176|144229966|SUPERIORITY||LSMean difference|-5.3|STANDARD_ERROR_OF_MEAN|1.89||0.0051|TWO_SIDED|95.0|-9.07|-1.62||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 11||-1.62|-9.07|0.0051
72356780|NCT03192176|144229966|SUPERIORITY||LSMean difference|-6.6|STANDARD_ERROR_OF_MEAN|1.87||0.0004|TWO_SIDED|95.0|-10.33|-2.96||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 11||-2.96|-10.33|0.0004
72356781|NCT03192176|144229966|SUPERIORITY||LSMean difference|-6.0|STANDARD_ERROR_OF_MEAN|1.86||0.0014|TWO_SIDED|95.0|-9.64|-2.34||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 11||-2.34|-9.64|0.0014
72356782|NCT03192176|144229966|SUPERIORITY||LSMean difference|-5.1|STANDARD_ERROR_OF_MEAN|1.82||0.0054|TWO_SIDED|95.0|-8.67|-1.51||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12||-1.51|-8.67|0.0054
72356783|NCT03192176|144229966|SUPERIORITY||LSMean difference|-6.1|STANDARD_ERROR_OF_MEAN|1.82||0.0008|TWO_SIDED|95.0|-9.71|-2.55||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12||-2.55|-9.71|0.0008
72356784|NCT03192176|144229966|SUPERIORITY||LSMean difference|-7.6|STANDARD_ERROR_OF_MEAN|1.84|<|0.0001|TWO_SIDED|95.0|-11.2|-3.97||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12||-3.97|-11.20|<0.0001
72356785|NCT03192176|144229966|SUPERIORITY||LSMean difference|-8.2|STANDARD_ERROR_OF_MEAN|1.85|<|0.0001|TWO_SIDED|95.0|-11.88|-4.59||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12||-4.59|-11.88|<0.0001
72356786|NCT03192176|144229966|SUPERIORITY||LSMean difference|-5.6|STANDARD_ERROR_OF_MEAN|1.85||0.0026|TWO_SIDED|95.0|-9.27|-1.99||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12||-1.99|-9.27|0.0026
72356787|NCT03192176|144229966|SUPERIORITY||LSMean difference|-6.8|STANDARD_ERROR_OF_MEAN|1.83||0.0003|TWO_SIDED|95.0|-10.35|-3.16||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12||-3.16|-10.35|0.0003
72356788|NCT03192176|144229966|SUPERIORITY||LSMean difference|-6.3|STANDARD_ERROR_OF_MEAN|1.81||0.0006|TWO_SIDED|95.0|-9.88|-2.75||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12||-2.75|-9.88|0.0006
72356789|NCT03192176|144229966|SUPERIORITY||LSMean difference|-5.3|STANDARD_ERROR_OF_MEAN|2.12||0.0126|TWO_SIDED|95.0|-9.48|-1.15||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 13||-1.15|-9.48|0.0126
72356790|NCT03192176|144229966|SUPERIORITY||LSMean difference|-2.9|STANDARD_ERROR_OF_MEAN|2.12||0.1724|TWO_SIDED|95.0|-7.06|1.27||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMMRM|||Week 13||1.27|-7.06|0.1724
72356791|NCT03192176|144229966|SUPERIORITY||LSMean difference|-2.0|STANDARD_ERROR_OF_MEAN|2.18||0.3548|TWO_SIDED|95.0|-6.31|2.27||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 13||2.27|-6.31|0.3548
72356792|NCT03192176|144229966|SUPERIORITY||LSMean difference|-3.8|STANDARD_ERROR_OF_MEAN|2.18||0.086|TWO_SIDED|95.0|-8.04|0.53||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|LSMean difference|||Week 13||0.53|-8.04|0.0860
72356793|NCT03192176|144229966|SUPERIORITY||LSMean difference|-5.6|STANDARD_ERROR_OF_MEAN|2.19||0.0111|TWO_SIDED|95.0|-9.89|-1.28||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 13||-1.28|-9.89|0.0111
72356794|NCT03192176|144229966|SUPERIORITY||LSMean difference|-4.6|STANDARD_ERROR_OF_MEAN|2.19||0.0349|TWO_SIDED|95.0|-8.94|-0.33||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 13||-0.33|-8.94|0.0349
72356795|NCT03192176|144229966|SUPERIORITY||LSMean difference|-2.6|STANDARD_ERROR_OF_MEAN|2.12||0.2205|TWO_SIDED|95.0|-6.77|1.57||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 13||1.57|-6.77|0.2205
72356796|NCT03192176|144229966|SUPERIORITY||LSMean differencce|-4.0|STANDARD_ERROR_OF_MEAN|2.17||0.0645|TWO_SIDED|95.0|-8.29|0.24||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 14||0.24|-8.29|0.0645
72356797|NCT03192176|144229966|SUPERIORITY||LSMean difference|-1.4|STANDARD_ERROR_OF_MEAN|2.16||0.5031|TWO_SIDED|95.0|-5.69|2.8||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 14||2.80|-5.69|0.5031
72356798|NCT03192176|144229966|SUPERIORITY||LSMean difference|-1.4|STANDARD_ERROR_OF_MEAN|2.24||0.5263|TWO_SIDED|95.0|-5.84|2.99||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 14||2.99|-5.84|0.5263
72356799|NCT03192176|144229966|SUPERIORITY||LSMean differencce|-2.4|STANDARD_ERROR_OF_MEAN|2.24||0.2782|TWO_SIDED|95.0|-6.83|1.97||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 14||1.97|-6.83|0.2782
72356800|NCT03192176|144229966|SUPERIORITY||LSMean difference|-5.3|STANDARD_ERROR_OF_MEAN|2.24||0.0198|TWO_SIDED|95.0|-9.67|-0.84||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 14||-0.84|-9.67|0.0198
72356801|NCT03192176|144229966|SUPERIORITY||LSMean difference|-4.6|STANDARD_ERROR_OF_MEAN|2.25||0.0417|TWO_SIDED|95.0|-9.05|-0.18||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 14||-0.18|-9.05|0.0417
72356802|NCT03192176|144229966|SUPERIORITY||LSMean difference|-2.3|STANDARD_ERROR_OF_MEAN|2.16||0.2963|TWO_SIDED|95.0|-6.52|2.0||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 14||2.00|-6.52|0.2963
72356803|NCT03192176|144229966|SUPERIORITY||LSMean difference|-1.3|STANDARD_ERROR_OF_MEAN|2.09||0.5408|TWO_SIDED|95.0|-5.39|2.83||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15||2.83|-5.39|0.5408
72356804|NCT03192176|144229966|SUPERIORITY||LSMean difference|-0.7|STANDARD_ERROR_OF_MEAN|2.07||0.7473|TWO_SIDED|95.0|-4.74|3.41||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15||3.41|-4.74|0.7473
72356805|NCT03192176|144229966|SUPERIORITY||LSMean difference|0.2|STANDARD_ERROR_OF_MEAN|2.18||0.9214|TWO_SIDED|95.0|-4.07|4.5||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15||4.50|-4.07|0.9214
72356806|NCT03192176|144229966|SUPERIORITY||LSMean difference|0.0|STANDARD_ERROR_OF_MEAN|2.14||0.9876|TWO_SIDED|95.0|-4.19|4.26||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15||4.26|-4.19|0.9876
72356807|NCT03192176|144229966|SUPERIORITY||LSMean difference|-2.6|STANDARD_ERROR_OF_MEAN|2.18||0.2379|TWO_SIDED|95.0|-6.86|1.71||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15||1.71|-6.86|0.2379
72356808|NCT03192176|144229966|SUPERIORITY||LSMean difference|-3.2|STANDARD_ERROR_OF_MEAN|2.18||0.1491|TWO_SIDED|95.0|-7.45|1.14||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15||1.14|-7.45|0.1491
72356809|NCT03192176|144229966|SUPERIORITY||LSMean difference|0.1|STANDARD_ERROR_OF_MEAN|2.07||0.956|TWO_SIDED|95.0|-3.96|4.19||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15||4.19|-3.96|0.9560
72356810|NCT03192176|144229967|SUPERIORITY||LSMean difference|-5.2|STANDARD_ERROR_OF_MEAN|1.96||0.0089|TWO_SIDED|95.0|-9.01|-1.3||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 1||-1.30|-9.01|0.0089
72356811|NCT03192176|144229967|SUPERIORITY||LSMean difference|-8.4|STANDARD_ERROR_OF_MEAN|1.97|<|0.0001|TWO_SIDED|95.0|-12.22|-4.48||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 1||-4.48|-12.22|<0.0001
72356812|NCT03192176|144229967|SUPERIORITY||LSMean difference|-9.2|STANDARD_ERROR_OF_MEAN|1.96|<|0.0001|TWO_SIDED|95.0|-13.06|-5.34||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 1||-5.34|-13.06|<0.0001
72356813|NCT03192176|144229967|SUPERIORITY||LSMean difference|-10.7|STANDARD_ERROR_OF_MEAN|1.99|<|0.0001|TWO_SIDED|95.0|-14.58|-6.75||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 1||-6.75|-14.58|<0.0001
72356814|NCT03192176|144229967|SUPERIORITY||LSMean difference|-3.7|STANDARD_ERROR_OF_MEAN|2.0||0.063|TWO_SIDED|95.0|-7.65|0.2||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 1||0.20|-7.65|0.0630
72356815|NCT03192176|144229967|SUPERIORITY||LSMean difference|-7.2|STANDARD_ERROR_OF_MEAN|1.97||0.0003|TWO_SIDED|95.0|-11.04|-3.3||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 1||-3.30|-11.04|0.0003
72356816|NCT03192176|144229967|SUPERIORITY||LSMean difference|-6.7|STANDARD_ERROR_OF_MEAN|1.96||0.0007|TWO_SIDED|95.0|-10.53|-2.84||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 1||-2.84|-10.53|0.0007
72356817|NCT03192176|144229967|SUPERIORITY||LSMean difference|-4.5|STANDARD_ERROR_OF_MEAN|1.98||0.0231|TWO_SIDED|95.0|-8.43|-0.63||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 2||-0.63|-8.43|0.0231
72356818|NCT03192176|144229967|SUPERIORITY||LSMean difference|-8.0|STANDARD_ERROR_OF_MEAN|1.99|<|0.0001|TWO_SIDED|95.0|-11.94|-4.09||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 2||-4.09|-11.94|<0.0001
72356819|NCT03192176|144229967|SUPERIORITY||LSMean differencce|-8.0|STANDARD_ERROR_OF_MEAN|1.99|<|0.0001|TWO_SIDED|95.0|-11.87|-4.05||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 2||-4.05|-11.87|<0.0001
72356820|NCT03192176|144229967|SUPERIORITY||LSMean difference|-9.2|STANDARD_ERROR_OF_MEAN|2.02|<|0.0001|TWO_SIDED|95.0|-13.21|-5.26||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 2||-5.26|-13.21|<0.0001
72356821|NCT03192176|144229967|SUPERIORITY||LSMean difference|-4.8|STANDARD_ERROR_OF_MEAN|2.02||0.0177|TWO_SIDED|95.0|-8.8|-0.84||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 2||-0.84|-8.80|0.0177
72356822|NCT03192176|144229967|SUPERIORITY||LSMean difference|-6.5|STANDARD_ERROR_OF_MEAN|1.99||0.0012|TWO_SIDED|95.0|-10.45|-2.6||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 2||-2.60|-10.45|0.0012
72356823|NCT03192176|144229967|SUPERIORITY||LSMean difference|-6.6|STANDARD_ERROR_OF_MEAN|2.04||0.0072|TWO_SIDED|95.0|-9.26|-2.64||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 2||-2.64|-9.26|0.0072
72356824|NCT03192176|144229967|SUPERIORITY||LSMean difference|-5.9|STANDARD_ERROR_OF_MEAN|2.04||0.0044|TWO_SIDED|95.0|-9.86|-1.84||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 3||-1.84|-9.86|0.0044
72356825|NCT03192176|144229967|SUPERIORITY||LSMean difference|-9.2|STANDARD_ERROR_OF_MEAN|2.05|<|0.0001|TWO_SIDED|95.0|-13.27|-5.21||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 3||-5.21|-13.27|<0.0001
72356826|NCT03192176|144229967|SUPERIORITY||LSMean difference|-8.6|STANDARD_ERROR_OF_MEAN|2.04|<|0.0001|TWO_SIDED|95.0|-12.57|-4.55||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 3||-4.55|-12.57|<0.0001
72356827|NCT03192176|144229967|SUPERIORITY||LSMean difference|-10.2|STANDARD_ERROR_OF_MEAN|2.08|<|0.0001|TWO_SIDED|95.0|-14.29|-6.11||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 3||-6.11|-14.29|<0.0001
72356828|NCT03192176|144229967|SUPERIORITY||LSMean difference|-7.0|STANDARD_ERROR_OF_MEAN|2.08||0.0009|TWO_SIDED|95.0|-11.04|-2.87||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 3||-2.87|-11.04|0.0009
72356829|NCT03192176|144229967|SUPERIORITY||LSMean difference|-8.4|STANDARD_ERROR_OF_MEAN|2.05|<|0.0001|TWO_SIDED|95.0|-12.44|-4.39||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 3||-4.39|-12.44|<0.0001
72356830|NCT03192176|144229967|SUPERIORITY||LSMean difference|-6.6|STANDARD_ERROR_OF_MEAN|2.04||0.0012|TWO_SIDED|95.0|-10.65|-2.64||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 3||-2.64|-10.65|0.0012
72356831|NCT03192176|144229967|SUPERIORITY||LSMean difference|-5.7|STANDARD_ERROR_OF_MEAN|2.04||0.0053|TWO_SIDED|95.0|-9.72|-1.71||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4||-1.71|-9.72|0.0053
72356832|NCT03192176|144229967|SUPERIORITY||LSMean difference|-8.8|STANDARD_ERROR_OF_MEAN|2.04|<|0.0001|TWO_SIDED|95.0|-12.77|-4.73||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4||-4.73|-12.77|<0.0001
72356833|NCT03192176|144229967|SUPERIORITY||LSMean difference|-7.8|STANDARD_ERROR_OF_MEAN|2.04||0.0001|TWO_SIDED|95.0|-11.84|-3.84||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4||-3.84|-11.84|0.0001
72356834|NCT03192176|144229967|SUPERIORITY||LSMean difference|-10.0|STANDARD_ERROR_OF_MEAN|2.07|<|0.0001|TWO_SIDED|95.0|-14.12|-5.96||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4||-5.96|-14.12|<0.0001
72356835|NCT03192176|144229967|SUPERIORITY||LSMean difference|-6.9|STANDARD_ERROR_OF_MEAN|2.07||0.001|TWO_SIDED|95.0|-10.92|-2.78||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4||-2.78|-10.92|0.0010
72356836|NCT03192176|144229967|SUPERIORITY||LSMean difference|-8.5|STANDARD_ERROR_OF_MEAN|2.04|<|0.0001|TWO_SIDED|95.0|-12.49|-4.46||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4||-4.46|-12.49|<0.0001
72356837|NCT03192176|144229967|SUPERIORITY||LSMean difference|-7.1|STANDARD_ERROR_OF_MEAN|2.03||0.0005|TWO_SIDED|95.0|-11.12|-3.13||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4||-3.13|-11.12|0.0005
72356838|NCT03192176|144229967|SUPERIORITY||LSMean difference|-5.4|STANDARD_ERROR_OF_MEAN|1.93||0.0057|TWO_SIDED|95.0|-9.15|-1.58||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 5||-1.58|-9.15|0.0057
72356839|NCT03192176|144229967|SUPERIORITY||LSMean difference|-8.4|STANDARD_ERROR_OF_MEAN|1.93|<|0.0001|TWO_SIDED|95.0|-12.15|-4.56||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 5||-4.56|-12.15|<0.0001
72356840|NCT03192176|144229967|SUPERIORITY||LSMean difference|-7.9|STANDARD_ERROR_OF_MEAN|1.93|<|0.0001|TWO_SIDED|95.0|-11.68|-4.08||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 5||-4.08|-11.68|<0.0001
72356841|NCT03192176|144229967|SUPERIORITY||LSMean difference|-9.8|STANDARD_ERROR_OF_MEAN|1.96|<|0.0001|TWO_SIDED|95.0|-13.66|-5.93||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 5||-5.93|-13.66|<0.0001
72356842|NCT03192176|144229967|SUPERIORITY||LSMean difference|-6.7|STANDARD_ERROR_OF_MEAN|1.95||0.0007|TWO_SIDED|95.0|-10.54|-2.85||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 5||-2.85|-10.54|0.0007
72356843|NCT03192176|144229967|SUPERIORITY||LSMean difference|-7.7|STANDARD_ERROR_OF_MEAN|1.93|<|0.0001|TWO_SIDED|95.0|-11.55|-3.95||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 5||-3.95|-11.55|<0.0001
72356844|NCT03192176|144229967|SUPERIORITY||LSMean difference|-6.4|STANDARD_ERROR_OF_MEAN|1.92||0.001|TWO_SIDED|95.0|-10.16|-2.6||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 5||-2.60|-10.16|0.0010
72356845|NCT03192176|144229967|SUPERIORITY||LSMean difference|-5.2|STANDARD_ERROR_OF_MEAN|1.91||0.0064|TWO_SIDED|95.0|-8.99|-1.48||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 6||-1.48|-8.99|0.0064
72356846|NCT03192176|144229967|SUPERIORITY||LSMean difference|-7.2|STANDARD_ERROR_OF_MEAN|1.91||0.0002|TWO_SIDED|95.0|-10.94|-3.42||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 6||-3.42|-10.94|0.0002
72356847|NCT03192176|144229967|SUPERIORITY||LSMean difference|-7.5|STANDARD_ERROR_OF_MEAN|1.92||0.0001|TWO_SIDED|95.0|-11.29|-3.75||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 6||-3.75|-11.29|0.0001
72356848|NCT03192176|144229967|SUPERIORITY||LSMean difference|-8.9|STANDARD_ERROR_OF_MEAN|1.95|<|0.0001|TWO_SIDED|95.0|-12.69|-5.03||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 6||-5.03|-12.69|<0.0001
72356849|NCT03192176|144229967|SUPERIORITY||LSMean difference|-5.8|STANDARD_ERROR_OF_MEAN|1.94||0.003|TWO_SIDED|95.0|-9.62|-1.99||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 6||-1.99|-9.62|0.0030
72356850|NCT03192176|144229967|SUPERIORITY||LSMean difference|-7.1|STANDARD_ERROR_OF_MEAN|1.92||0.0002|TWO_SIDED|95.0|-10.92|-3.37||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 6||-3.37|-10.92|0.0002
72356851|NCT03192176|144229967|SUPERIORITY||LSMean difference|-6.2|STANDARD_ERROR_OF_MEAN|1.9||0.0013|TWO_SIDED|95.0|-9.91|-2.42||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 6||-2.42|-9.91|0.0013
72356852|NCT03192176|144229967|SUPERIORITY||LSMean difference|-4.8|STANDARD_ERROR_OF_MEAN|1.94||0.0137|TWO_SIDED|95.0|-8.61|-0.99||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 7||-0.99|-8.61|0.0137
72356853|NCT03192176|144229967|SUPERIORITY||LSMean difference|-7.4|STANDARD_ERROR_OF_MEAN|1.94||0.0002|TWO_SIDED|95.0|-11.24|-3.6||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 7||-3.60|-11.24|0.0002
72356854|NCT03192176|144229967|SUPERIORITY||LSMean difference|-7.0|STANDARD_ERROR_OF_MEAN|1.95||0.0004|TWO_SIDED|95.0|-10.79|-3.13||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 7||-3.13|-10.79|0.0004
72356855|NCT03192176|144229967|SUPERIORITY||LSMean difference|-8.9|STANDARD_ERROR_OF_MEAN|1.98|<|0.0001|TWO_SIDED|95.0|-12.74|-4.97||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 7||-4.97|-12.74|<0.0001
72356856|NCT03192176|144229967|SUPERIORITY||LSMean difference|-5.9|STANDARD_ERROR_OF_MEAN|1.97||0.0028|TWO_SIDED|95.0|-9.82|-2.07||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 7||-2.07|-9.82|0.0028
72356857|NCT03192176|144229967|SUPERIORITY||LSMean difference|-6.8|STANDARD_ERROR_OF_MEAN|1.95||0.0006|TWO_SIDED|95.0|-10.6|-2.94||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 7||-2.94|-10.60|0.0006
72356858|NCT03192176|144229967|SUPERIORITY||LSMean difference|-6.0|STANDARD_ERROR_OF_MEAN|1.93||0.002|TWO_SIDED|95.0|-9.82|-2.21||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 7||-2.21|-9.82|0.0020
72356859|NCT03192176|144229967|SUPERIORITY||LSMean difference|-3.7|STANDARD_ERROR_OF_MEAN|1.93||0.0588|TWO_SIDED|95.0|-7.46|0.14||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8||0.14|-7.46|0.0588
72356860|NCT03192176|144229967|SUPERIORITY||LSMean difference|-3.7|STANDARD_ERROR_OF_MEAN|1.93||0.0018|TWO_SIDED|95.0|-9.9|0.14||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8||0.14|-9.90|0.0018
72356861|NCT03192176|144229967|SUPERIORITY||LSMean difference|-6.2|STANDARD_ERROR_OF_MEAN|1.94||0.0017|TWO_SIDED|95.0|-9.98|-2.34||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8||-2.34|-9.98|0.0017
72356862|NCT03192176|144229967|SUPERIORITY||LSMean difference|-7.2|STANDARD_ERROR_OF_MEAN|1.97||0.0003|TWO_SIDED|95.0|-11.09|-3.32||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8||-3.32|-11.09|0.0003
72356863|NCT03192176|144229967|SUPERIORITY||LSMean difference|-4.7|STANDARD_ERROR_OF_MEAN|1.97||0.081|TWO_SIDED|95.0|-8.55|-0.81||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8||-0.81|-8.55|0.0810
72356864|NCT03192176|144229967|SUPERIORITY||LSMean difference|-6.1|STANDARD_ERROR_OF_MEAN|1.94||0.002|TWO_SIDED|95.0|-9.88|-2.23||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8||-2.23|-9.88|0.0020
72356865|NCT03192176|144229967|SUPERIORITY||LSMean difference|-5.2|STANDARD_ERROR_OF_MEAN|1.93||0.0076|TWO_SIDED|95.0|-8.98|-1.39||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8||-1.39|-8.98|0.0076
72356866|NCT03192176|144229967|SUPERIORITY||LSMean difference|-4.4|STANDARD_ERROR_OF_MEAN|1.85||0.0182|TWO_SIDED|95.0|-8.01|-0.75||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 9||-0.75|-8.01|0.0182
72356867|NCT03192176|144229967|SUPERIORITY||LSMean difference|-5.8|STANDARD_ERROR_OF_MEAN|1.84||0.0019|TWO_SIDED|95.0|-9.42|-2.16||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 9||-2.16|-9.42|0.0019
72356868|NCT03192176|144229967|SUPERIORITY||LSMean difference|-6.4|STANDARD_ERROR_OF_MEAN|1.86||0.0007|TWO_SIDED|95.0|-10.02|-2.71||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 9||-2.71|-10.02|0.0007
72356869|NCT03192176|144229967|SUPERIORITY||LSMean difference|-7.1|STANDARD_ERROR_OF_MEAN|1.88||0.0002|TWO_SIDED|95.0|-10.76|-3.35||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 9||-3.35|-10.76|0.0002
72356870|NCT03192176|144229967|SUPERIORITY||LSMean difference|-4.2|STANDARD_ERROR_OF_MEAN|1.88||0.0263|TWO_SIDED|95.0|-7.89|-0.5||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 9||-0.50|-7.89|0.0263
72356871|NCT03192176|144229967|SUPERIORITY||LSMean difference|-6.0|STANDARD_ERROR_OF_MEAN|1.86||0.0015|TWO_SIDED|95.0|-9.61|-2.29||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 9||-2.29|-9.61|0.0015
72356872|NCT03192176|144229967|SUPERIORITY||LSMean difference|-4.7|STANDARD_ERROR_OF_MEAN|1.84||0.0113|TWO_SIDED|95.0|-8.32|-1.07||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 9||-1.07|-8.32|0.0113
72356873|NCT03192176|144229967|SUPERIORITY||LSMean difference|-5.3|STANDARD_ERROR_OF_MEAN|1.91||0.0059|TWO_SIDED|95.0|-9.04|-1.54||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 10||-1.54|-9.04|0.0059
72356874|NCT03192176|144229967|SUPERIORITY||LSMean difference|-6.0|STANDARD_ERROR_OF_MEAN|1.91||0.0018|TWO_SIDED|95.0|-9.76|-2.25||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 10||-2.25|-9.76|0.0018
72356875|NCT03192176|144229967|SUPERIORITY||LSMean difference|-6.8|STANDARD_ERROR_OF_MEAN|1.93||0.0004|TWO_SIDED|95.0|-10.62|-3.05||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 10||-3.05|-10.62|0.0004
72356876|NCT03192176|144229967|SUPERIORITY||LSMean difference|-7.6|STANDARD_ERROR_OF_MEAN|1.95||0.0001|TWO_SIDED|95.0|-11.39|-3.73||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 10||-3.73|-11.39|0.0001
72356877|NCT03192176|144229967|SUPERIORITY||LSMean difference|-5.6|STANDARD_ERROR_OF_MEAN|1.94||0.0044|TWO_SIDED|95.0|-9.4|-1.75||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Wek 10||-1.75|-9.40|0.0044
72356878|NCT03192176|144229967|SUPERIORITY||LSMean difference|-6.6|STANDARD_ERROR_OF_MEAN|1.92||0.0006|TWO_SIDED|95.0|-10.4|-2.84||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 10||-2.84|-10.40|0.0006
72356879|NCT03192176|144229967|SUPERIORITY||LSMean difference|-5.8|STANDARD_ERROR_OF_MEAN|1.91||0.0025|TWO_SIDED|95.0|-9.57|-2.07||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 10||-2.07|-9.57|0.0025
72356880|NCT03192176|144229967|SUPERIORITY||LSMean difference|-5.2|STANDARD_ERROR_OF_MEAN|1.86||0.0059|TWO_SIDED|95.0|-8.81|-1.49||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 11||-1.49|-8.81|0.0059
72356881|NCT03192176|144229967|SUPERIORITY||LSMean difference|-6.4|STANDARD_ERROR_OF_MEAN|1.86||0.0007|TWO_SIDED|95.0|-10.06|-2.74||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 11||-2.74|-10.06|0.0007
72356882|NCT03192176|144229967|SUPERIORITY||LSMean difference|-7.5|STANDARD_ERROR_OF_MEAN|1.88|<|0.0001|TWO_SIDED|95.0|-11.18|-3.79||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 11||-3.79|-11.18|<0.0001
72356883|NCT03192176|144229967|SUPERIORITY||LSMean difference|-7.5|STANDARD_ERROR_OF_MEAN|1.9||0.0001|TWO_SIDED|95.0|-11.18|-3.72||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 11||-3.72|-11.18|0.0001
72356884|NCT03192176|144229967|SUPERIORITY||LSMean difference|-5.8|STANDARD_ERROR_OF_MEAN|1.89||0.0022|TWO_SIDED|95.0|-9.56|-2.11||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 11||-2.11|-9.56|0.0022
72356885|NCT03192176|144229967|SUPERIORITY||LSMean difference|-6.9|STANDARD_ERROR_OF_MEAN|1.87||0.0003|TWO_SIDED|95.0|-10.56|-3.19||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 11||-3.19|-10.56|0.0003
72356886|NCT03192176|144229967|SUPERIORITY||LSMean difference|-5.8|STANDARD_ERROR_OF_MEAN|1.86||0.002|TWO_SIDED|95.0|-9.44|-2.13||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 11||-2.13|-9.44|0.0020
72356887|NCT03192176|144229967|SUPERIORITY||LSMean difference|-5.6|STANDARD_ERROR_OF_MEAN|1.82||0.0023|TWO_SIDED|95.0|-9.18|-2.01||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12||-2.01|-9.18|0.0023
72356888|NCT03192176|144229967|SUPERIORITY||LSMean difference|-6.5|STANDARD_ERROR_OF_MEAN|1.82||0.0004|TWO_SIDED|95.0|-10.06|-2.89||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12||-2.89|-10.06|0.0004
72356889|NCT03192176|144229967|SUPERIORITY||LSMean difference|-7.4|STANDARD_ERROR_OF_MEAN|1.84|<|0.0001|TWO_SIDED|95.0|-11.05|-3.81||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12||-3.81|-11.05|<0.0001
72356890|NCT03192176|144229967|SUPERIORITY||LSMean difference|-8.1|STANDARD_ERROR_OF_MEAN|1.86|<|0.0001|TWO_SIDED|95.0|-11.8|-4.49||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12||-4.49|-11.80|<0.0001
72356891|NCT03192176|144229967|SUPERIORITY||LSMean difference|-6.1|STANDARD_ERROR_OF_MEAN|1.85||0.0011|TWO_SIDED|95.0|-9.77|-2.47||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12||-2.47|-9.77|0.0011
72356892|NCT03192176|144229967|SUPERIORITY||LSMean difference|-6.9|STANDARD_ERROR_OF_MEAN|1.83||0.0002|TWO_SIDED|95.0|-10.54|-3.32||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12||-3.32|-10.54|0.0002
72356893|NCT03192176|144229967|SUPERIORITY||LSMean difference|-6.1|STANDARD_ERROR_OF_MEAN|1.82||0.0008|TWO_SIDED|95.0|-9.71|-2.56||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12||-2.56|-9.71|0.0008
72356894|NCT03192176|144229967|SUPERIORITY||LSMean difference|-6.0|STANDARD_ERROR_OF_MEAN|2.15||0.0054|TWO_SIDED|95.0|-10.26|-1.8||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 13||-1.80|-10.26|0.0054
72356895|NCT03192176|144229967|SUPERIORITY||LSMean difference|-3.4|STANDARD_ERROR_OF_MEAN|2.15||0.1145|TWO_SIDED|95.0|-7.63|0.83||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMMRM|||Week 13||0.83|-7.63|0.1145
72356896|NCT03192176|144229967|SUPERIORITY||LSMean difference|-2.8|STANDARD_ERROR_OF_MEAN|2.21||0.2106|TWO_SIDED|95.0|-7.13|1.58||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 13||1.58|-7.13|0.2106
72356897|NCT03192176|144229967|SUPERIORITY||LSMean difference|-4.0|STANDARD_ERROR_OF_MEAN|2.21||0.0685|TWO_SIDED|95.0|-8.39|0.31||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|LSMean difference|||Week 13||0.31|-8.39|0.0685
72356898|NCT03192176|144229967|SUPERIORITY||LSMean difference|-6.7|STANDARD_ERROR_OF_MEAN|2.22||0.0029|TWO_SIDED|95.0|-11.02|-2.29||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 13||-2.29|-11.02|0.0029
72356899|NCT03192176|144229967|SUPERIORITY||LSMean difference|-5.0|STANDARD_ERROR_OF_MEAN|2.22||0.0239|TWO_SIDED|95.0|-9.42|-0.67||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 13||-0.67|-9.42|0.0239
72356900|NCT03192176|144229967|SUPERIORITY||LSMean difference|-2.6|STANDARD_ERROR_OF_MEAN|2.15||0.2224|TWO_SIDED|95.0|-6.86|1.6||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 13||1.60|-6.86|0.2224
72356901|NCT03192176|144229967|SUPERIORITY||LSMean differencce|-4.8|STANDARD_ERROR_OF_MEAN|2.22||0.0308|TWO_SIDED|95.0|-9.17|-0.45||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 14||-0.45|-9.17|0.0308
72356902|NCT03192176|144229967|SUPERIORITY||LSMean difference|-1.8|STANDARD_ERROR_OF_MEAN|2.21||0.4194|TWO_SIDED|95.0|-6.13|2.56||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 14||2.56|-6.13|0.4194
72356903|NCT03192176|144229967|SUPERIORITY||LSMean difference|-2.0|STANDARD_ERROR_OF_MEAN|2.29||0.3759|TWO_SIDED|95.0|-6.55|2.48||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 14||2.48|-6.55|0.3759
72356904|NCT03192176|144229967|SUPERIORITY||LSMean differencce|-2.8|STANDARD_ERROR_OF_MEAN|2.29||0.2285|TWO_SIDED|95.0|-7.26|1.74||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 14||1.74|-7.26|0.2285
72356905|NCT03192176|144229967|SUPERIORITY||LSMean difference|-6.2|STANDARD_ERROR_OF_MEAN|2.29||0.0072|TWO_SIDED|95.0|-10.71|-1.7||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 14||-1.70|-10.71|0.0072
72356906|NCT03192176|144229967|SUPERIORITY||LSMean difference|-4.9|STANDARD_ERROR_OF_MEAN|2.31||0.0338|TWO_SIDED|95.0|-9.46|-0.38||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 14||-0.38|-9.46|0.0338
72356907|NCT03192176|144229967|SUPERIORITY||LSMean difference|-2.3|STANDARD_ERROR_OF_MEAN|2.21||0.3026|TWO_SIDED|95.0|-6.64|2.07||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 14||2.07|-6.64|0.3026
72356908|NCT03192176|144229967|SUPERIORITY||LSMean difference|-2.2|STANDARD_ERROR_OF_MEAN|2.16||0.312|TWO_SIDED|95.0|-6.45|2.07||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15||2.07|-6.45|0.3120
72356909|NCT03192176|144229967|SUPERIORITY||LSMean difference|-0.9|STANDARD_ERROR_OF_MEAN|2.15||0.6816|TWO_SIDED|95.0|-5.11|3.34||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15||3.34|-5.11|0.6816
72356910|NCT03192176|144229967|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|2.26||0.8599|TWO_SIDED|95.0|-4.85|4.05||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15||4.05|-4.85|0.8599
72356911|NCT03192176|144229967|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|2.23||0.9093|TWO_SIDED|95.0|-4.64|4.13||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15||4.13|-4.64|0.9093
72356912|NCT03192176|144229967|SUPERIORITY||LSMean difference|-4.0|STANDARD_ERROR_OF_MEAN|2.26||0.0788|TWO_SIDED|95.0|-8.43|0.46||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15||0.46|-8.43|0.0788
72356913|NCT03192176|144229967|SUPERIORITY||LSMean difference|-3.5|STANDARD_ERROR_OF_MEAN|2.26||0.1278|TWO_SIDED|95.0|-7.92|1.0||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15||1.00|-7.92|0.1278
72356914|NCT03192176|144229967|SUPERIORITY||LSMean difference|0.0|STANDARD_ERROR_OF_MEAN|2.15||0.9848|TWO_SIDED|95.0|-4.19|4.27||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15||4.27|-4.19|0.9848
72356915|NCT03192176|144229968|SUPERIORITY||LSMean difference|14.6|STANDARD_ERROR_OF_MEAN|7.05||0.0388|TWO_SIDED|95.0|0.76|28.49||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|MMRM: Mixed Model Repeated Measures||Week 1||28.49|0.76|0.0388
72356916|NCT03192176|144229968|SUPERIORITY||LSMean difference|23.1|STANDARD_ERROR_OF_MEAN|7.08||0.0012|TWO_SIDED|95.0|9.17|37.02||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 1||37.02|9.17|0.0012
72356917|NCT03192176|144229968|SUPERIORITY||LSMean difference|37.3|STANDARD_ERROR_OF_MEAN|7.07|<|0.0001|TWO_SIDED|95.0|23.41|51.22||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 1||51.22|23.41|<0.0001
72356918|NCT03192176|144229968|SUPERIORITY||LSMean difference|41.0|STANDARD_ERROR_OF_MEAN|7.16|<|0.0001|TWO_SIDED|95.0|26.88|55.05||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 1||55.05|26.88|<0.0001
72356919|NCT03192176|144229968|SUPERIORITY||LSMean difference|8.2|STANDARD_ERROR_OF_MEAN|7.19||0.2569|TWO_SIDED|95.0|-5.98|22.32||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 1||22.32|-5.98|0.2569
72356920|NCT03192176|144229968|SUPERIORITY||LSMean difference|25.6|STANDARD_ERROR_OF_MEAN|7.07||0.0003|TWO_SIDED|95.0|11.65|39.47||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 1||39.47|11.65|0.0003
72356921|NCT03192176|144229968|SUPERIORITY||LSMean difference|30.2|STANDARD_ERROR_OF_MEAN|7.03|<|0.0001|TWO_SIDED|95.0|16.39|44.06||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 1||44.06|16.39|<0.0001
72356922|NCT03192176|144229968|SUPERIORITY||LSMean difference|15.9|STANDARD_ERROR_OF_MEAN|7.02||0.024|TWO_SIDED|95.0|2.11|29.71||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 2||29.71|2.11|0.0240
72356923|NCT03192176|144229968|SUPERIORITY||LSMean difference|24.5|STANDARD_ERROR_OF_MEAN|7.05||0.0006|TWO_SIDED|95.0|10.62|38.37||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 2||38.37|10.62|0.0006
72356924|NCT03192176|144229968|SUPERIORITY||LSMean differencce|33.7|STANDARD_ERROR_OF_MEAN|7.03|<|0.0001|TWO_SIDED|95.0|19.87|47.52||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 2||47.52|19.87|<0.0001
72356925|NCT03192176|144229968|SUPERIORITY||LSMean difference|38.0|STANDARD_ERROR_OF_MEAN|7.15|<|0.0001|TWO_SIDED|95.0|23.93|52.04||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 2||52.04|23.93|<0.0001
72356926|NCT03192176|144229968|SUPERIORITY||LSMean difference|14.5|STANDARD_ERROR_OF_MEAN|7.16||0.0441|TWO_SIDED|95.0|0.38|28.53||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 2||28.53|0.38|0.0441
72356927|NCT03192176|144229968|SUPERIORITY||LSMean difference|19.4|STANDARD_ERROR_OF_MEAN|7.04||0.0061|TWO_SIDED|95.0|5.58|33.28||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 2||33.28|5.58|0.0061
72356928|NCT03192176|144229968|SUPERIORITY||LSMean difference|25.7|STANDARD_ERROR_OF_MEAN|7.01||0.0003|TWO_SIDED|95.0|11.96|39.53||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 2||39.53|11.96|0.0003
72356929|NCT03192176|144229968|SUPERIORITY||LSMean difference|20.2|STANDARD_ERROR_OF_MEAN|7.55||0.0078|TWO_SIDED|95.0|5.36|35.07||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 3||35.07|5.36|0.0078
72356930|NCT03192176|144229968|SUPERIORITY||LSMean difference|28.3|STANDARD_ERROR_OF_MEAN|7.59||0.0002|TWO_SIDED|95.0|13.36|43.22||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 3||43.22|13.36|0.0002
72356931|NCT03192176|144229968|SUPERIORITY||LSMean difference|36.9|STANDARD_ERROR_OF_MEAN|7.55|<|0.0001|TWO_SIDED|95.0|22.07|51.77||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 3||51.77|22.07|<0.0001
72356932|NCT03192176|144229968|SUPERIORITY||LSMean difference|40.5|STANDARD_ERROR_OF_MEAN|7.69|<|0.0001|TWO_SIDED|95.0|25.41|55.67||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRm|||Week 3||55.67|25.41|<0.0001
72356933|NCT03192176|144229968|SUPERIORITY||LSMean difference|19.7|STANDARD_ERROR_OF_MEAN|7.7||0.0108|TWO_SIDED|95.0|4.59|34.88||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 3||34.88|4.59|0.0108
72356934|NCT03192176|144229968|SUPERIORITY||LSMean difference|25.0|STANDARD_ERROR_OF_MEAN|7.56||0.0011|TWO_SIDED|95.0|10.09|39.84||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 3||39.84|10.09|0.0011
72356935|NCT03192176|144229968|SUPERIORITY||LSMean difference|30.9|STANDARD_ERROR_OF_MEAN|7.53|<|0.0001|TWO_SIDED|95.0|16.03|45.67||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 3||45.67|16.03|<0.0001
72356936|NCT03192176|144229968|SUPERIORITY||LSMean difference|20.5|STANDARD_ERROR_OF_MEAN|7.47||0.0063|TWO_SIDED|95.0|5.84|35.23||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 4||35.23|5.84|0.0063
72356937|NCT03192176|144229968|SUPERIORITY||LSMean difference|28.7|STANDARD_ERROR_OF_MEAN|7.49||0.0002|TWO_SIDED|95.0|13.98|43.46||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 4||43.46|13.98|0.0002
72356938|NCT03192176|144229968|SUPERIORITY||LSMean difference|33.3|STANDARD_ERROR_OF_MEAN|7.46|<|0.0001|TWO_SIDED|95.0|18.66|48.0||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 4||48.00|18.66|<0.0001
72356939|NCT03192176|144229968|SUPERIORITY||LSMean difference|41.5|STANDARD_ERROR_OF_MEAN|7.6|<|0.0001|TWO_SIDED|95.0|26.52|56.41||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 4||56.41|26.52|<0.0001
72356940|NCT03192176|144229968|SUPERIORITY||LSMean difference|19.7|STANDARD_ERROR_OF_MEAN|7.59||0.0098|TWO_SIDED|95.0|4.78|34.66||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 4||34.66|4.78|0.0098
72356941|NCT03192176|144229968|SUPERIORITY||LSMean difference|29.9|STANDARD_ERROR_OF_MEAN|7.46|<|0.0001|TWO_SIDED|95.0|15.26|44.61||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 4||44.61|15.26|<0.0001
72356942|NCT03192176|144229968|SUPERIORITY||LSMean difference|33.1|STANDARD_ERROR_OF_MEAN|7.43|<|0.0001|TWO_SIDED|95.0|18.5|47.73||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 4||47.73|18.50|<0.0001
72356943|NCT03192176|144229968|SUPERIORITY||LSMean difference|15.4|STANDARD_ERROR_OF_MEAN|7.1||0.0303|TWO_SIDED|95.0|1.48|29.4||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 5||29.40|1.48|0.0303
72356944|NCT03192176|144229968|SUPERIORITY||LSMean difference|24.8|STANDARD_ERROR_OF_MEAN|7.11||0.0006|TWO_SIDED|95.0|10.77|38.74||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 5||38.74|10.77|0.0006
72356945|NCT03192176|144229968|SUPERIORITY||LSMean difference|30.8|STANDARD_ERROR_OF_MEAN|7.11|<|0.0001|TWO_SIDED|95.0|16.77|44.75||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 5||44.75|16.77|<0.0001
72356946|NCT03192176|144229968|SUPERIORITY||LSMean difference|38.8|STANDARD_ERROR_OF_MEAN|7.23|<|0.0001|TWO_SIDED|95.0|24.55|53.0||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 5||53.00|24.55|<0.0001
72356947|NCT03192176|144229968|SUPERIORITY||LSMean difference|19.1|STANDARD_ERROR_OF_MEAN|7.2||0.0086|TWO_SIDED|95.0|4.88|33.23||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 5||33.23|4.88|0.0086
72356948|NCT03192176|144229968|SUPERIORITY||LSMean difference|22.3|STANDARD_ERROR_OF_MEAN|7.09||0.0018|TWO_SIDED|95.0|8.33|36.24||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 5||36.24|8.33|0.0018
72356949|NCT03192176|144229968|SUPERIORITY||LSMean difference|25.1|STANDARD_ERROR_OF_MEAN|7.07||0.0004|TWO_SIDED|95.0|11.24|39.05||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 5||39.05|11.24|0.0004
72356950|NCT03192176|144229968|SUPERIORITY||LSMean difference|14.6|STANDARD_ERROR_OF_MEAN|6.62||0.0282|TWO_SIDED|95.0|1.56|27.6||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 6||27.60|1.56|0.0282
72356951|NCT03192176|144229968|SUPERIORITY||LSMean difference|19.9|STANDARD_ERROR_OF_MEAN|6.63||0.0029|TWO_SIDED|95.0|6.85|32.92||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 6||32.92|6.85|0.0029
72356952|NCT03192176|144229968|SUPERIORITY||LSMean difference|29.7|STANDARD_ERROR_OF_MEAN|6.65|<|0.0001|TWO_SIDED|95.0|16.58|42.73||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 6||42.73|16.58|<0.0001
72356953|NCT03192176|144229968|SUPERIORITY||LSMean difference|35.7|STANDARD_ERROR_OF_MEAN|6.75|<|0.0001|TWO_SIDED|95.0|22.42|48.99||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 6||48.99|22.42|<0.0001
72356954|NCT03192176|144229968|SUPERIORITY||LSMean difference|14.6|STANDARD_ERROR_OF_MEAN|6.74||0.0304|TWO_SIDED|95.0|1.4|27.9||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 6||27.90|1.40|0.0304
72356955|NCT03192176|144229968|SUPERIORITY||LSMean difference|20.4|STANDARD_ERROR_OF_MEAN|6.64||0.0022|TWO_SIDED|95.0|7.38|33.5||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 6||33.50|7.38|0.0022
72356956|NCT03192176|144229968|SUPERIORITY||LSMean difference|26.5|STANDARD_ERROR_OF_MEAN|6.59|<|0.0001|TWO_SIDED|95.0|13.56|39.5||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 6||39.50|13.56|<0.0001
72356957|NCT03192176|144229968|SUPERIORITY||LSMean difference|14.4|STANDARD_ERROR_OF_MEAN|6.87||0.0362|TWO_SIDED|95.0|0.93|27.95||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 7||27.95|0.93|0.0362
72356958|NCT03192176|144229968|SUPERIORITY||LSMean difference|22.9|STANDARD_ERROR_OF_MEAN|6.88||0.0009|TWO_SIDED|95.0|9.41|36.47||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 7||36.47|9.41|0.0009
72356959|NCT03192176|144229968|SUPERIORITY||LSMean difference|28.9|STANDARD_ERROR_OF_MEAN|6.91|<|0.0001|TWO_SIDED|95.0|15.27|42.46||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 7||42.46|15.27|<0.0001
72356960|NCT03192176|144229968|SUPERIORITY||LSMean difference|36.8|STANDARD_ERROR_OF_MEAN|7.01|<|0.0001|TWO_SIDED|95.0|22.99|50.57||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 7||50.57|22.99|<0.0001
72356961|NCT03192176|144229968|SUPERIORITY||LSMean difference|15.6|STANDARD_ERROR_OF_MEAN|6.99||0.0265|TWO_SIDED|95.0|1.83|29.34||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 7||29.34|1.83|0.0265
72356962|NCT03192176|144229968|SUPERIORITY||LSMean difference|21.2|STANDARD_ERROR_OF_MEAN|6.89||0.0023|TWO_SIDED|95.0|7.6|34.71||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 7||34.71|7.60|0.0023
72356963|NCT03192176|144229968|SUPERIORITY||LSMean difference|27.1|STANDARD_ERROR_OF_MEAN|6.85|<|0.0001|TWO_SIDED|95.0|13.64|40.59||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 7||40.59|13.64|<0.0001
72356964|NCT03192176|144229968|SUPERIORITY||LSMean difference|9.6|STANDARD_ERROR_OF_MEAN|6.8||0.158|TWO_SIDED|95.0|-3.75|22.99||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 8||22.99|-3.75|0.1580
72356965|NCT03192176|144229968|SUPERIORITY||LSMean difference|18.1|STANDARD_ERROR_OF_MEAN|6.8||0.0082|TWO_SIDED|95.0|4.72|31.5||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 8||31.50|4.72|0.0082
72356966|NCT03192176|144229968|SUPERIORITY||LSMean difference|25.2|STANDARD_ERROR_OF_MEAN|6.85||0.0003|TWO_SIDED|95.0|11.77|38.71||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 8||38.71|11.77|0.0003
72356967|NCT03192176|144229968|SUPERIORITY||LSMean difference|30.6|STANDARD_ERROR_OF_MEAN|6.96|<|0.0001|TWO_SIDED|95.0|16.93|44.31||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 8||44.31|16.93|<0.0001
72356968|NCT03192176|144229968|SUPERIORITY||LSMean difference|11.2|STANDARD_ERROR_OF_MEAN|6.93||0.1074|TWO_SIDED|95.0|-2.45|24.84||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 8||24.84|-2.45|0.1074
72356969|NCT03192176|144229968|SUPERIORITY||LSMean difference|18.3|STANDARD_ERROR_OF_MEAN|6.83||0.0077|TWO_SIDED|95.0|4.87|31.76||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 8||31.76|4.87|0.0077
72356970|NCT03192176|144229968|SUPERIORITY||LSMean difference|23.6|STANDARD_ERROR_OF_MEAN|6.79||0.0006|TWO_SIDED|95.0|10.29|37.01||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 8||37.01|10.29|0.0006
72356971|NCT03192176|144229968|SUPERIORITY||LSMean difference|11.8|STANDARD_ERROR_OF_MEAN|6.47||0.0689|TWO_SIDED|95.0|-0.92|24.53||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 9||24.53|-0.92|0.0689
72356972|NCT03192176|144229968|SUPERIORITY||LSMean difference|14.6|STANDARD_ERROR_OF_MEAN|6.46||0.025|TWO_SIDED|95.0|1.84|27.27||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 9||27.27|1.84|0.0250
72356973|NCT03192176|144229968|SUPERIORITY||LSMean difference|24.4|STANDARD_ERROR_OF_MEAN|6.51||0.0002|TWO_SIDED|95.0|11.54|37.17||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 9||37.17|11.54|0.0002
72356974|NCT03192176|144229968|SUPERIORITY||LSMean difference|29.6|STANDARD_ERROR_OF_MEAN|6.6|<|0.0001|TWO_SIDED|95.0|16.6|42.57||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 9||42.57|16.60|<0.0001
72356975|NCT03192176|144229968|SUPERIORITY||LSMean difference|8.4|STANDARD_ERROR_OF_MEAN|6.59||0.2041|TWO_SIDED|95.0|-4.58|21.36||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 9||21.36|-4.58|0.2041
72356976|NCT03192176|144229968|SUPERIORITY||LSMean difference|18.4|STANDARD_ERROR_OF_MEAN|6.5||0.0049|TWO_SIDED|95.0|5.62|31.2||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 9||31.20|5.62|0.0049
72356977|NCT03192176|144229968|SUPERIORITY||LSMean difference|20.7|STANDARD_ERROR_OF_MEAN|6.45||0.0015|TWO_SIDED|95.0|8.0|33.37||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 9||33.37|8.00|0.0015
72356978|NCT03192176|144229968|SUPERIORITY||LSMean difference|15.8|STANDARD_ERROR_OF_MEAN|6.66||0.0184|TWO_SIDED|95.0|2.68|28.89||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 10||28.89|2.68|0.0184
72356979|NCT03192176|144229968|SUPERIORITY||LSMean difference|12.8|STANDARD_ERROR_OF_MEAN|6.66||0.0551|TWO_SIDED|95.0|-0.28|25.93||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 10||25.93|-0.28|0.0551
72356980|NCT03192176|144229968|SUPERIORITY||LSMean difference|25.8|STANDARD_ERROR_OF_MEAN|6.73||0.0002|TWO_SIDED|95.0|12.51|39.0||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 10||39.00|12.51|0.0002
72356981|NCT03192176|144229968|SUPERIORITY||LSMean difference|31.6|STANDARD_ERROR_OF_MEAN|6.8|<|0.0001|TWO_SIDED|95.0|18.17|44.93||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 10||44.93|18.17|<0.0001
72356982|NCT03192176|144229968|SUPERIORITY||LSMean difference|14.3|STANDARD_ERROR_OF_MEAN|6.79||0.0367|TWO_SIDED|95.0|0.89|27.62||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Wek 10||27.62|0.89|0.0367
72356983|NCT03192176|144229968|SUPERIORITY||LSMean difference|21.2|STANDARD_ERROR_OF_MEAN|6.7||0.0017|TWO_SIDED|95.0|7.99|34.34||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 10||34.34|7.99|0.0017
72429309|NCT01154036|144369653|SUPERIORITY_OR_OTHER_LEGACY||Difference in M-estimates|-10.5|||<|0.001|TWO_SIDED|95.0|-15.9|-5.1||The secondary hypotheses were tested at an adaptive alpha level depending on the hypotheses testing result of the primary hypotheses.|Multiple Imputation Robust Regression|M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values||||-5.1|-15.9|<0.001
72356984|NCT03192176|144229968|SUPERIORITY||LSMean difference|24.4|STANDARD_ERROR_OF_MEAN|6.65||0.0003|TWO_SIDED|95.0|11.29|37.44||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 10||37.44|11.29|0.0003
72356985|NCT03192176|144229968|SUPERIORITY||LSMean difference|14.5|STANDARD_ERROR_OF_MEAN|6.45||0.0255|TWO_SIDED|95.0|1.78|27.15||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 11||27.15|1.78|0.0255
72356986|NCT03192176|144229968|SUPERIORITY||LSMean difference|15.3|STANDARD_ERROR_OF_MEAN|6.45||0.0186|TWO_SIDED|95.0|2.57|27.94||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 11||27.94|2.57|0.0186
72356987|NCT03192176|144229968|SUPERIORITY||LSMean difference|26.5|STANDARD_ERROR_OF_MEAN|6.52|<|0.0001|TWO_SIDED|95.0|13.71|39.36||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 11||39.36|13.71|<0.0001
72356988|NCT03192176|144229968|SUPERIORITY||LSMean difference|29.9|STANDARD_ERROR_OF_MEAN|6.58|<|0.0001|TWO_SIDED|95.0|16.94|42.81||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 11||42.81|16.94|<0.0001
72356989|NCT03192176|144229968|SUPERIORITY||LSMean difference|13.9|STANDARD_ERROR_OF_MEAN|6.57||0.0347|TWO_SIDED|95.0|1.01|26.85||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 11||26.85|1.01|0.0347
72356990|NCT03192176|144229968|SUPERIORITY||LSMean difference|21.9|STANDARD_ERROR_OF_MEAN|6.48||0.0008|TWO_SIDED|95.0|9.16|34.65||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 11||34.65|9.16|0.0008
72356991|NCT03192176|144229968|SUPERIORITY||LSMean difference|23.4|STANDARD_ERROR_OF_MEAN|6.43||0.0003|TWO_SIDED|95.0|10.75|36.04||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 11||36.04|10.75|0.0003
72356992|NCT03192176|144229968|SUPERIORITY||LSMean difference|14.8|STANDARD_ERROR_OF_MEAN|6.43||0.0221|TWO_SIDED|95.0|2.13|27.43||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 12||27.43|2.13|0.0221
72356993|NCT03192176|144229968|SUPERIORITY||LSMean difference|17.0|STANDARD_ERROR_OF_MEAN|6.43||0.0087|TWO_SIDED|95.0|4.32|29.62||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 12||29.62|4.32|0.0087
72356994|NCT03192176|144229968|SUPERIORITY||LSMean difference|26.4|STANDARD_ERROR_OF_MEAN|6.5|<|0.0001|TWO_SIDED|95.0|13.65|39.23||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 12||39.23|13.65|<0.0001
72356995|NCT03192176|144229968|SUPERIORITY||LSMean difference|31.0|STANDARD_ERROR_OF_MEAN|6.56|<|0.0001|TWO_SIDED|95.0|18.13|43.94||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 12||43.94|18.13|<0.0001
72356996|NCT03192176|144229968|SUPERIORITY||LSMean difference|14.8|STANDARD_ERROR_OF_MEAN|6.55||0.0244|TWO_SIDED|95.0|1.92|27.7||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 12||27.70|1.92|0.0244
72356997|NCT03192176|144229968|SUPERIORITY||LSMean difference|21.9|STANDARD_ERROR_OF_MEAN|6.46||0.0008|TWO_SIDED|95.0|9.21|34.62||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 12||34.62|9.21|0.0008
72356998|NCT03192176|144229968|SUPERIORITY||LSMean difference|23.2|STANDARD_ERROR_OF_MEAN|6.41||0.0003|TWO_SIDED|95.0|10.63|35.83||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 12||35.83|10.63|0.0003
72356999|NCT03192176|144229968|SUPERIORITY||LSMean difference|9.8|STANDARD_ERROR_OF_MEAN|7.38||0.1871|TWO_SIDED|95.0|-4.77|24.3||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 13||24.30|-4.77|0.1871
72357000|NCT03192176|144229968|SUPERIORITY||LSMean difference|2.3|STANDARD_ERROR_OF_MEAN|7.38||0.7552|TWO_SIDED|95.0|-12.23|16.83||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMMRM|||Week 13||16.83|-12.23|0.7552
72357001|NCT03192176|144229968|SUPERIORITY||LSMean difference|1.5|STANDARD_ERROR_OF_MEAN|7.61||0.8407|TWO_SIDED|95.0|-13.44|16.5||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 13||16.50|-13.44|0.8407
72357002|NCT03192176|144229968|SUPERIORITY||LSMean difference|7.2|STANDARD_ERROR_OF_MEAN|7.6||0.345|TWO_SIDED|95.0|-7.77|22.14||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|LSMean difference|||Week 13||22.14|-7.77|0.3450
72357003|NCT03192176|144229968|SUPERIORITY||LSMean difference|5.7|STANDARD_ERROR_OF_MEAN|7.66||0.455|TWO_SIDED|95.0|-9.34|20.8||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 13||20.80|-9.34|0.4550
72357004|NCT03192176|144229968|SUPERIORITY||LSMean difference|10.4|STANDARD_ERROR_OF_MEAN|7.64||0.1747|TWO_SIDED|95.0|-4.64|25.44||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 13||25.44|-4.64|0.1747
72357005|NCT03192176|144229968|SUPERIORITY||LSMean difference|4.4|STANDARD_ERROR_OF_MEAN|7.38||0.5476|TWO_SIDED|95.0|-10.08|18.97||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 13||18.97|-10.08|0.5476
72357006|NCT03192176|144229968|SUPERIORITY||LSMean difference|2.1|STANDARD_ERROR_OF_MEAN|8.01||0.7954|TWO_SIDED|95.0|-13.69|17.84||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 14||17.84|-13.69|0.7954
72357007|NCT03192176|144229968|SUPERIORITY||LSMean differencce|1.3|STANDARD_ERROR_OF_MEAN|7.96||0.8731|TWO_SIDED|95.0|-14.41|16.95||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 14||16.95|-14.41|0.8731
72357008|NCT03192176|144229968|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|8.31||0.9689|TWO_SIDED|95.0|-16.68|16.03||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 14||16.03|-16.68|0.9689
72357009|NCT03192176|144229968|SUPERIORITY||LSMean difference|3.9|STANDARD_ERROR_OF_MEAN|8.28||0.6378|TWO_SIDED|95.0|-12.4|20.21||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 14||20.21|-12.40|0.6378
72357010|NCT03192176|144229968|SUPERIORITY||LSMean differencce|1.6|STANDARD_ERROR_OF_MEAN|8.33||0.8503|TWO_SIDED|95.0|-14.82|17.97||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 14||17.97|-14.82|0.8503
72357011|NCT03192176|144229968|SUPERIORITY||LSMean difference|13.0|STANDARD_ERROR_OF_MEAN|8.37||0.1224|TWO_SIDED|95.0|-3.51|29.44||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 14||29.44|-3.51|0.1224
72357012|NCT03192176|144229968|SUPERIORITY||LSMean difference|7.1|STANDARD_ERROR_OF_MEAN|7.99||0.3743|TWO_SIDED|95.0|-8.62|22.85||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 14||22.85|-8.62|0.3743
72357013|NCT03192176|144229968|SUPERIORITY||LSMean difference|-7.9|STANDARD_ERROR_OF_MEAN|7.89||0.3173|TWO_SIDED|95.0|-23.44|7.63||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 15||7.63|-23.44|0.3173
72357014|NCT03192176|144229968|SUPERIORITY||LSMean difference|-2.1|STANDARD_ERROR_OF_MEAN|7.82||0.7905|TWO_SIDED|95.0|-17.48|13.32||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 15||13.32|-17.48|0.7905
72357015|NCT03192176|144229968|SUPERIORITY||LSMean difference|-7.2|STANDARD_ERROR_OF_MEAN|8.24||0.3804|TWO_SIDED|95.0|-23.46|8.98||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 15||8.98|-23.46|0.3804
72357016|NCT03192176|144229968|SUPERIORITY||LSMean difference|-5.6|STANDARD_ERROR_OF_MEAN|8.11||0.4905|TWO_SIDED|95.0|-21.58|10.38||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 15||10.38|-21.58|0.4905
72357017|NCT03192176|144229968|SUPERIORITY||LSMean difference|-12.6|STANDARD_ERROR_OF_MEAN|8.25||0.1289|TWO_SIDED|95.0|-28.83|3.68||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 15||3.68|-28.83|0.1289
72357018|NCT03192176|144229968|SUPERIORITY||LSMean difference|6.4|STANDARD_ERROR_OF_MEAN|8.24||0.4398|TWO_SIDED|95.0|-9.86|22.61||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 15||22.61|-9.86|0.4398
72357019|NCT03192176|144229968|SUPERIORITY||LSMean difference|-2.1|STANDARD_ERROR_OF_MEAN|7.81||0.7921|TWO_SIDED|95.0|-17.45|13.33||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 15||13.33|-17.45|0.7921
72357020|NCT03192176|144229969|SUPERIORITY||LSMean difference|19.1|STANDARD_ERROR_OF_MEAN|7.28||0.009|TWO_SIDED|95.0|4.82|33.46||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|MMRM: Mixed Model Repeated Measures||Week 1||33.46|4.82|0.0090
72357021|NCT03192176|144229969|SUPERIORITY||LSMean difference|27.0|STANDARD_ERROR_OF_MEAN|7.32||0.0003|TWO_SIDED|95.0|12.61|41.39||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 1||41.39|12.61|0.0003
72357022|NCT03192176|144229969|SUPERIORITY||LSMean difference|39.5|STANDARD_ERROR_OF_MEAN|7.31|<|0.0001|TWO_SIDED|95.0|25.14|53.9||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 1||53.90|25.14|<0.0001
72357023|NCT03192176|144229969|SUPERIORITY||LSMean difference|44.8|STANDARD_ERROR_OF_MEAN|7.4|<|0.0001|TWO_SIDED|95.0|30.27|59.39||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 1||59.39|30.27|<0.0001
72357024|NCT03192176|144229969|SUPERIORITY||LSMean difference|12.2|STANDARD_ERROR_OF_MEAN|7.43||0.1019|TWO_SIDED|95.0|-2.43|26.79||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 1||26.79|-2.43|0.1019
72357025|NCT03192176|144229969|SUPERIORITY||LSMean difference|27.8|STANDARD_ERROR_OF_MEAN|7.31||0.0002|TWO_SIDED|95.0|13.45|42.22||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 1||42.22|13.45|0.0002
72357026|NCT03192176|144229969|SUPERIORITY||LSMean difference|29.5|STANDARD_ERROR_OF_MEAN|7.27|<|0.0001|TWO_SIDED|95.0|15.21|43.82||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 1||43.82|15.21|<0.0001
72357027|NCT03192176|144229969|SUPERIORITY||LSMean difference|19.9|STANDARD_ERROR_OF_MEAN|7.03||0.0049|TWO_SIDED|95.0|6.1|33.76||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 2||33.76|6.10|0.0049
72357028|NCT03192176|144229969|SUPERIORITY||LSMean difference|28.6|STANDARD_ERROR_OF_MEAN|7.07|<|0.0001|TWO_SIDED|95.0|14.64|42.46||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 2||42.46|14.64|<0.0001
72357029|NCT03192176|144229969|SUPERIORITY||LSMean differencce|33.8|STANDARD_ERROR_OF_MEAN|7.05|<|0.0001|TWO_SIDED|95.0|19.96|47.69||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 2||47.69|19.96|<0.0001
72357030|NCT03192176|144229969|SUPERIORITY||LSMean difference|39.5|STANDARD_ERROR_OF_MEAN|7.16|<|0.0001|TWO_SIDED|95.0|25.4|53.58||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 2||53.58|25.40|<0.0001
72357031|NCT03192176|144229969|SUPERIORITY||LSMean difference|17.6|STANDARD_ERROR_OF_MEAN|7.17||0.0146|TWO_SIDED|95.0|3.5|31.7||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 2||31.70|3.50|0.0146
72357032|NCT03192176|144229969|SUPERIORITY||LSMean difference|24.1|STANDARD_ERROR_OF_MEAN|7.06||0.0007|TWO_SIDED|95.0|10.21|38.0||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 2||38.00|10.21|0.0007
72357033|NCT03192176|144229969|SUPERIORITY||LSMean difference|23.9|STANDARD_ERROR_OF_MEAN|7.03||0.0008|TWO_SIDED|95.0|10.05|37.7||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 2||37.70|10.05|0.0008
72357034|NCT03192176|144229969|SUPERIORITY||LSMean difference|23.2|STANDARD_ERROR_OF_MEAN|7.46||0.002|TWO_SIDED|95.0|8.56|37.9||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 3||37.90|8.56|0.0020
72357035|NCT03192176|144229969|SUPERIORITY||LSMean difference|34.4|STANDARD_ERROR_OF_MEAN|7.5|<|0.0001|TWO_SIDED|95.0|19.6|49.11||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 3||49.11|19.60|<0.0001
72357036|NCT03192176|144229969|SUPERIORITY||LSMean difference|35.6|STANDARD_ERROR_OF_MEAN|7.46|<|0.0001|TWO_SIDED|95.0|20.96|50.32||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 3||50.32|20.96|<0.0001
72357037|NCT03192176|144229969|SUPERIORITY||LSMean difference|43.0|STANDARD_ERROR_OF_MEAN|7.6|<|0.0001|TWO_SIDED|95.0|28.03|57.93||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 3||57.93|28.03|<0.0001
72357038|NCT03192176|144229969|SUPERIORITY||LSMean difference|25.4|STANDARD_ERROR_OF_MEAN|7.6||0.0009|TWO_SIDED|95.0|10.48|40.37||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 3||40.37|10.48|0.0009
72357039|NCT03192176|144229969|SUPERIORITY||LSMean difference|31.2|STANDARD_ERROR_OF_MEAN|7.48|<|0.0001|TWO_SIDED|95.0|16.49|45.9||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 3||45.90|16.49|<0.0001
72357040|NCT03192176|144229969|SUPERIORITY||LSMean difference|28.9|STANDARD_ERROR_OF_MEAN|7.44||0.0001|TWO_SIDED|95.0|14.24|43.52||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 3||43.52|14.24|0.0001
72357041|NCT03192176|144229969|SUPERIORITY||LSMean difference|23.1|STANDARD_ERROR_OF_MEAN|7.42||0.0021|TWO_SIDED|95.0|8.46|37.66||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 4||37.66|8.46|0.0021
72357042|NCT03192176|144229969|SUPERIORITY||LSMean difference|32.1|STANDARD_ERROR_OF_MEAN|7.45|<|0.0001|TWO_SIDED|95.0|17.42|46.71||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 4||46.71|17.42|<0.0001
72357043|NCT03192176|144229969|SUPERIORITY||LSMean difference|31.3|STANDARD_ERROR_OF_MEAN|7.42|<|0.0001|TWO_SIDED|95.0|16.73|45.91||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 4||45.91|16.73|<0.0001
72357044|NCT03192176|144229969|SUPERIORITY||LSMean difference|41.8|STANDARD_ERROR_OF_MEAN|7.56|<|0.0001|TWO_SIDED|95.0|26.95|56.68||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 4||56.68|26.95|<0.0001
72357045|NCT03192176|144229969|SUPERIORITY||LSMean difference|25.6|STANDARD_ERROR_OF_MEAN|7.54||0.0008|TWO_SIDED|95.0|10.77|40.43||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 4||40.43|10.77|0.0008
72357046|NCT03192176|144229969|SUPERIORITY||LSMean difference|31.3|STANDARD_ERROR_OF_MEAN|7.42|<|0.0001|TWO_SIDED|95.0|16.75|45.94||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 4||45.94|16.75|<0.0001
72357047|NCT03192176|144229969|SUPERIORITY||LSMean difference|29.4|STANDARD_ERROR_OF_MEAN|7.39|<|0.0001|TWO_SIDED|95.0|14.91|43.97||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 4||43.97|14.91|<0.0001
72357048|NCT03192176|144229969|SUPERIORITY||LSMean difference|20.2|STANDARD_ERROR_OF_MEAN|7.05||0.0045|TWO_SIDED|95.0|6.31|34.06||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 5||34.06|6.31|0.0045
72357049|NCT03192176|144229969|SUPERIORITY||LSMean difference|30.6|STANDARD_ERROR_OF_MEAN|7.07|<|0.0001|TWO_SIDED|95.0|16.68|44.49||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 5||44.49|16.68|<0.0001
72357050|NCT03192176|144229969|SUPERIORITY||LSMean difference|29.1|STANDARD_ERROR_OF_MEAN|7.08|<|0.0001|TWO_SIDED|95.0|15.14|42.98||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 5||42.98|15.14|<0.0001
72357051|NCT03192176|144229969|SUPERIORITY||LSMean difference|40.1|STANDARD_ERROR_OF_MEAN|7.19|<|0.0001|TWO_SIDED|95.0|25.96|54.26||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 5||54.26|25.96|<0.0001
72357052|NCT03192176|144229969|SUPERIORITY||LSMean difference|24.4|STANDARD_ERROR_OF_MEAN|7.15||0.0007|TWO_SIDED|95.0|10.28|38.42||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 5||38.42|10.28|0.0007
72357053|NCT03192176|144229969|SUPERIORITY||LSMean difference|26.7|STANDARD_ERROR_OF_MEAN|7.06||0.0002|TWO_SIDED|95.0|1.78|40.55||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 5||40.55|1.78|0.0002
72357054|NCT03192176|144229969|SUPERIORITY||LSMean difference|23.4|STANDARD_ERROR_OF_MEAN|7.03||0.001|TWO_SIDED|95.0|9.55|37.22||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 5||37.22|9.55|0.0010
72357055|NCT03192176|144229969|SUPERIORITY||LSMean difference|19.1|STANDARD_ERROR_OF_MEAN|6.6||0.004|TWO_SIDED|95.0|6.13|32.11||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 6||32.11|6.13|0.0040
72357056|NCT03192176|144229969|SUPERIORITY||LSMean difference|23.8|STANDARD_ERROR_OF_MEAN|6.62||0.0004|TWO_SIDED|95.0|10.8|36.83||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 6||36.83|10.80|0.0004
72357057|NCT03192176|144229969|SUPERIORITY||LSMean difference|27.2|STANDARD_ERROR_OF_MEAN|6.64|<|0.0001|TWO_SIDED|95.0|14.1|40.24||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 6||40.24|14.10|<0.0001
72357058|NCT03192176|144229969|SUPERIORITY||LSMean difference|35.6|STANDARD_ERROR_OF_MEAN|6.75|<|0.0001|TWO_SIDED|95.0|22.34|48.88||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 6||48.88|22.34|<0.0001
72357059|NCT03192176|144229969|SUPERIORITY||LSMean difference|20.0|STANDARD_ERROR_OF_MEAN|6.72||0.0032|TWO_SIDED|95.0|6.76|33.19||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 6||33.19|6.76|0.0032
72357060|NCT03192176|144229969|SUPERIORITY||LSMean difference|24.1|STANDARD_ERROR_OF_MEAN|6.64||0.0003|TWO_SIDED|95.0|11.02|37.13||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 6||37.13|11.02|0.0003
72357061|NCT03192176|144229969|SUPERIORITY||LSMean difference|23.1|STANDARD_ERROR_OF_MEAN|6.59||0.0005|TWO_SIDED|95.0|10.17|36.08||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 6||36.08|10.17|0.0005
72357062|NCT03192176|144229969|SUPERIORITY||LSMean difference|17.6|STANDARD_ERROR_OF_MEAN|6.82||0.0102|TWO_SIDED|95.0|4.2|31.04||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 7||31.04|4.20|0.0102
72357063|NCT03192176|144229969|SUPERIORITY||LSMean difference|25.9|STANDARD_ERROR_OF_MEAN|6.83||0.0002|TWO_SIDED|95.0|12.42|39.29||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 7||39.29|12.42|0.0002
72357064|NCT03192176|144229969|SUPERIORITY||LSMean difference|25.8|STANDARD_ERROR_OF_MEAN|6.87||0.0002|TWO_SIDED|95.0|12.29|39.33||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 7||39.33|12.29|0.0002
72357065|NCT03192176|144229969|SUPERIORITY||LSMean difference|36.3|STANDARD_ERROR_OF_MEAN|6.97|<|0.0001|TWO_SIDED|95.0|22.58|49.98||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 7||49.98|22.58|<0.0001
72357066|NCT03192176|144229969|SUPERIORITY||LSMean difference|20.6|STANDARD_ERROR_OF_MEAN|6.94||0.0031|TWO_SIDED|95.0|7.0|34.29||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 7||34.29|7.00|0.0031
72357067|NCT03192176|144229969|SUPERIORITY||LSMean difference|22.9|STANDARD_ERROR_OF_MEAN|6.85||0.0009|TWO_SIDED|95.0|9.43|36.38||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 7||36.38|9.43|0.0009
72357068|NCT03192176|144229969|SUPERIORITY||LSMean difference|22.8|STANDARD_ERROR_OF_MEAN|6.8||0.0009|TWO_SIDED|95.0|9.42|36.19||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 7||36.19|9.42|0.0009
72357069|NCT03192176|144229969|SUPERIORITY||LSMean difference|13.8|STANDARD_ERROR_OF_MEAN|6.71||0.0408|TWO_SIDED|95.0|0.58|26.97||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 8||26.97|0.58|0.0408
72357070|NCT03192176|144229969|SUPERIORITY||LSMean difference|20.0|STANDARD_ERROR_OF_MEAN|6.72||0.0031|TWO_SIDED|95.0|6.77|33.21||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 8||33.21|6.77|0.0031
72357071|NCT03192176|144229969|SUPERIORITY||LSMean difference|22.1|STANDARD_ERROR_OF_MEAN|6.76||0.0012|TWO_SIDED|95.0|8.8|35.4||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 8||35.40|8.80|0.0012
72357072|NCT03192176|144229969|SUPERIORITY||LSMean difference|29.9|STANDARD_ERROR_OF_MEAN|6.87|<|0.0001|TWO_SIDED|95.0|16.39|43.42||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 8||43.42|16.39|<0.0001
72357073|NCT03192176|144229969|SUPERIORITY||LSMean difference|14.9|STANDARD_ERROR_OF_MEAN|6.84||0.0303|TWO_SIDED|95.0|1.42|28.32||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 8||28.32|1.42|0.0303
72357074|NCT03192176|144229969|SUPERIORITY||LSMean difference|19.6|STANDARD_ERROR_OF_MEAN|6.75||0.004|TWO_SIDED|95.0|6.3|32.87||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 8||32.87|6.30|0.0040
72357075|NCT03192176|144229969|SUPERIORITY||LSMean difference|19.5|STANDARD_ERROR_OF_MEAN|6.71||0.0038|TWO_SIDED|95.0|6.34|32.73||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 8||32.73|6.34|0.0038
72357076|NCT03192176|144229969|SUPERIORITY||LSMean difference|16.0|STANDARD_ERROR_OF_MEAN|6.45||0.0137|TWO_SIDED|95.0|3.29|28.68||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 9||28.68|3.29|0.0137
72357077|NCT03192176|144229969|SUPERIORITY||LSMean difference|18.1|STANDARD_ERROR_OF_MEAN|6.45||0.0052|TWO_SIDED|95.0|5.44|30.82||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 9||30.82|5.44|0.0052
72357078|NCT03192176|144229969|SUPERIORITY||LSMean difference|22.6|STANDARD_ERROR_OF_MEAN|6.5||0.0006|TWO_SIDED|95.0|9.81|35.39||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 9||35.39|9.81|0.0006
72357079|NCT03192176|144229969|SUPERIORITY||LSMean difference|29.4|STANDARD_ERROR_OF_MEAN|6.58|<|0.0001|TWO_SIDED|95.0|16.41|42.32||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 9||42.32|16.41|<0.0001
72357080|NCT03192176|144229969|SUPERIORITY||LSMean difference|13.7|STANDARD_ERROR_OF_MEAN|6.57||0.0378|TWO_SIDED|95.0|0.78|26.63||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 9||26.63|0.78|0.0378
72357081|NCT03192176|144229969|SUPERIORITY||LSMean difference|20.1|STANDARD_ERROR_OF_MEAN|6.49||0.002|TWO_SIDED|95.0|7.31|32.85||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 9||32.85|7.31|0.002
72357082|NCT03192176|144229969|SUPERIORITY||LSMean difference|17.4|STANDARD_ERROR_OF_MEAN|6.44||0.0071|TWO_SIDED|95.0|4.77|30.09||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 9||30.09|4.77|0.0071
72357083|NCT03192176|144229969|SUPERIORITY||LSMean difference|20.7|STANDARD_ERROR_OF_MEAN|6.63||0.002|TWO_SIDED|95.0|7.61|33.71||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 10||33.71|7.61|0.0020
72357084|NCT03192176|144229969|SUPERIORITY||LSMean difference|18.7|STANDARD_ERROR_OF_MEAN|6.63||0.005|TWO_SIDED|95.0|5.68|31.79||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 10||31.79|5.68|0.0050
72357085|NCT03192176|144229969|SUPERIORITY||LSMean difference|24.4|STANDARD_ERROR_OF_MEAN|6.71||0.0003|TWO_SIDED|95.0|11.2|37.6||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 10||37.60|11.20|0.0003
72357086|NCT03192176|144229969|SUPERIORITY||LSMean difference|32.1|STANDARD_ERROR_OF_MEAN|6.77|<|0.0001|TWO_SIDED|95.0|18.77|45.42||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 10||45.42|18.77|<0.0001
72357087|NCT03192176|144229969|SUPERIORITY||LSMean difference|19.1|STANDARD_ERROR_OF_MEAN|6.76||0.005|TWO_SIDED|95.0|5.79|32.38||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Wek 10||32.38|5.79|0.0050
72357088|NCT03192176|144229969|SUPERIORITY||LSMean difference|23.1|STANDARD_ERROR_OF_MEAN|6.68||0.0006|TWO_SIDED|95.0|9.95|36.22||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 10||36.22|9.95|0.0006
72357089|NCT03192176|144229969|SUPERIORITY||LSMean difference|22.8|STANDARD_ERROR_OF_MEAN|6.62||0.0006|TWO_SIDED|95.0|9.79|35.85||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 10||35.85|9.79|0.0006
72357090|NCT03192176|144229969|SUPERIORITY||LSMean difference|18.5|STANDARD_ERROR_OF_MEAN|6.32||0.0036|TWO_SIDED|95.0|6.11|30.98||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 11||30.98|6.11|0.0036
72357091|NCT03192176|144229969|SUPERIORITY||LSMean difference|20.2|STANDARD_ERROR_OF_MEAN|6.32||0.0015|TWO_SIDED|95.0|7.77|32.65||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 11||32.65|7.77|0.0015
72357092|NCT03192176|144229969|SUPERIORITY||LSMean difference|25.0|STANDARD_ERROR_OF_MEAN|6.39||0.0001|TWO_SIDED|95.0|12.41|37.57||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 11||37.57|12.41|0.0001
72357093|NCT03192176|144229969|SUPERIORITY||LSMean difference|29.8|STANDARD_ERROR_OF_MEAN|6.45|<|0.0001|TWO_SIDED|95.0|17.12|42.49||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 11||42.49|17.12|<0.0001
72357094|NCT03192176|144229969|SUPERIORITY||LSMean difference|19.6|STANDARD_ERROR_OF_MEAN|6.43||0.0026|TWO_SIDED|95.0|6.9|32.21||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 11||32.21|6.90|0.0026
72357095|NCT03192176|144229969|SUPERIORITY||LSMean difference|23.4|STANDARD_ERROR_OF_MEAN|6.36||0.0003|TWO_SIDED|95.0|10.92|35.94||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 11||35.94|10.92|0.0003
72357096|NCT03192176|144229969|SUPERIORITY||LSMean difference|21.7|STANDARD_ERROR_OF_MEAN|6.3||0.0006|TWO_SIDED|95.0|9.34|34.14||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 11||34.14|9.34|0.0006
72357097|NCT03192176|144229969|SUPERIORITY||LSMean difference|19.3|STANDARD_ERROR_OF_MEAN|6.37||0.0026|TWO_SIDED|95.0|6.78|31.83||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 12||31.83|6.78|0.0026
72357098|NCT03192176|144229969|SUPERIORITY||LSMean difference|20.8|STANDARD_ERROR_OF_MEAN|6.36||0.0012|TWO_SIDED|95.0|8.29|33.33||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 12||33.33|8.29|0.0012
72357099|NCT03192176|144229969|SUPERIORITY||LSMean difference|25.1|STANDARD_ERROR_OF_MEAN|6.44||0.0001|TWO_SIDED|95.0|12.48|37.82||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 12||37.82|12.48|0.0001
72357100|NCT03192176|144229969|SUPERIORITY||LSMean difference|31.9|STANDARD_ERROR_OF_MEAN|6.5|<|0.0001|TWO_SIDED|95.0|19.11|44.67||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 12||44.67|19.11|<0.0001
72357101|NCT03192176|144229969|SUPERIORITY||LSMean difference|20.1|STANDARD_ERROR_OF_MEAN|6.48||0.0021|TWO_SIDED|95.0|7.32|32.81||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 12||32.81|7.32|0.0021
72357102|NCT03192176|144229969|SUPERIORITY||LSMean difference|22.7|STANDARD_ERROR_OF_MEAN|6.4||0.0004|TWO_SIDED|95.0|10.1|35.29||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 12||35.29|10.10|0.0004
72357103|NCT03192176|144229969|SUPERIORITY||LSMean difference|21.9|STANDARD_ERROR_OF_MEAN|6.34||0.0006|TWO_SIDED|95.0|9.42|34.38||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 12||34.38|9.42|0.0006
72357104|NCT03192176|144229969|SUPERIORITY||LSMean difference|17.0|STANDARD_ERROR_OF_MEAN|7.82||0.0304|TWO_SIDED|95.0|1.62|32.4||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 13||32.40|1.62|0.0304
72357105|NCT03192176|144229969|SUPERIORITY||LSMean difference|6.8|STANDARD_ERROR_OF_MEAN|7.82||0.3857|TWO_SIDED|95.0|-8.6|22.19||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMMRM|||Week 13||22.19|-8.60|0.3857
72357106|NCT03192176|144229969|SUPERIORITY||LSMean difference|7.5|STANDARD_ERROR_OF_MEAN|8.06||0.3497|TWO_SIDED|95.0|-8.31|23.4||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 13||23.40|-8.31|0.3497
72357107|NCT03192176|144229969|SUPERIORITY||LSMean difference|10.9|STANDARD_ERROR_OF_MEAN|8.05||0.1771|TWO_SIDED|95.0|-4.95|26.75||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|LSMean difference|||Week 13||26.75|-4.95|0.1771
72357108|NCT03192176|144229969|SUPERIORITY||LSMean difference|16.3|STANDARD_ERROR_OF_MEAN|8.1||0.0444|TWO_SIDED|95.0|0.41|32.29||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 13||32.29|0.41|0.0444
72357109|NCT03192176|144229969|SUPERIORITY||LSMean difference|11.7|STANDARD_ERROR_OF_MEAN|8.1||0.15|TWO_SIDED|95.0|-4.25|27.63||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 13||27.63|-4.25|0.1500
72357110|NCT03192176|144229969|SUPERIORITY||LSMean difference|3.9|STANDARD_ERROR_OF_MEAN|7.83||0.6196|TWO_SIDED|95.0|-11.51|19.29||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 13||19.29|-11.51|0.6196
72357111|NCT03192176|144229969|SUPERIORITY||LSMean difference|9.4|STANDARD_ERROR_OF_MEAN|8.48||0.2664|TWO_SIDED|95.0|-7.25|26.15||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 14||26.15|-7.25|0.2664
72357112|NCT03192176|144229969|SUPERIORITY||LSMean differencce|4.0|STANDARD_ERROR_OF_MEAN|8.44||0.6388|TWO_SIDED|95.0|-12.66|20.59||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 14||20.59|-12.66|0.6388
72357113|NCT03192176|144229969|SUPERIORITY||LSMean difference|4.9|STANDARD_ERROR_OF_MEAN|8.79||0.5797|TWO_SIDED|95.0|-12.43|22.19||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 14||22.19|-12.43|0.5797
72357114|NCT03192176|144229969|SUPERIORITY||LSMean difference|6.2|STANDARD_ERROR_OF_MEAN|8.78||0.4817|TWO_SIDED|95.0|-11.1|23.47||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 14||23.47|-11.10|0.4817
72357115|NCT03192176|144229969|SUPERIORITY||LSMean differencce|10.5|STANDARD_ERROR_OF_MEAN|8.8||0.2358|TWO_SIDED|95.0|-6.87|27.79||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 14||27.79|-6.87|0.2358
72357116|NCT03192176|144229969|SUPERIORITY||LSMean difference|14.3|STANDARD_ERROR_OF_MEAN|8.86||0.107|TWO_SIDED|95.0|-3.11|31.77||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 14||31.77|-3.11|0.1070
72357117|NCT03192176|144229969|SUPERIORITY||LSMean difference|6.7|STANDARD_ERROR_OF_MEAN|8.47||0.4268|TWO_SIDED|95.0|-9.94|23.43||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 14||23.43|-9.94|0.4268
72357118|NCT03192176|144229969|SUPERIORITY||LSMean difference|-0.9|STANDARD_ERROR_OF_MEAN|8.61||0.9197|TWO_SIDED|95.0|-17.81|16.08||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 15||16.08|-17.81|0.9197
72357119|NCT03192176|144229969|SUPERIORITY||LSMean difference|0.0|STANDARD_ERROR_OF_MEAN|8.54||0.9954|TWO_SIDED|95.0|-16.77|16.87||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 15||16.87|-16.77|0.9954
72357120|NCT03192176|144229969|SUPERIORITY||LSMean difference|0.4|STANDARD_ERROR_OF_MEAN|9.0||0.9607|TWO_SIDED|95.0|-17.28|18.17||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 15||18.17|-17.28|0.9607
72357121|NCT03192176|144229969|SUPERIORITY||LSMean difference|-3.9|STANDARD_ERROR_OF_MEAN|8.87||0.6625|TWO_SIDED|95.0|-21.33|13.59||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 15||13.59|-21.33|0.6625
72357122|NCT03192176|144229969|SUPERIORITY||LSMean difference|-0.1|STANDARD_ERROR_OF_MEAN|9.01||0.9952|TWO_SIDED|95.0|-17.81|17.7||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 15||17.70|-17.81|0.9952
72357123|NCT03192176|144229969|SUPERIORITY||LSMean difference|7.6|STANDARD_ERROR_OF_MEAN|9.02||0.4001|TWO_SIDED|95.0|-10.16|25.36||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 15||25.36|-10.16|0.4001
72357124|NCT03192176|144229969|SUPERIORITY||LSMean difference|-2.7|STANDARD_ERROR_OF_MEAN|8.54||0.751|TWO_SIDED|95.0|-19.52|14.1||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 15||14.10|-19.52|0.7510
72357125|NCT03192176|144229970|SUPERIORITY||Odds Ratio (OR)|6.02||||0.0018|TWO_SIDED|95.0|1.95|18.64||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||18.64|1.95|0.0018
72357126|NCT03192176|144229970|SUPERIORITY||Odds Ratio (OR)|8.28||||0.0002|TWO_SIDED|95.0|2.7|25.42||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||25.42|2.70|0.0002
72357127|NCT03192176|144229970|SUPERIORITY||Odds Ratio (OR)|10.92|||<|0.0001|TWO_SIDED|95.0|3.53|33.74||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||33.74|3.53|<0.0001
72357128|NCT03192176|144229970|SUPERIORITY||Odds Ratio (OR)|12.18|||<|0.0001|TWO_SIDED|95.0|3.91|37.89||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||37.89|3.91|<0.0001
72357129|NCT03192176|144229970|SUPERIORITY||Odds Ratio (OR)|2.1||||0.2244|TWO_SIDED|95.0|0.64|6.92||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||6.92|0.64|0.2244
72357130|NCT03192176|144229970|SUPERIORITY||Odds Ratio (OR)|8.58||||0.0002|TWO_SIDED|95.0|2.77|26.53||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||26.53|2.77|0.0002
72357131|NCT03192176|144229970|SUPERIORITY||Odds Ratio (OR)|8.25||||0.0002|TWO_SIDED|95.0|2.71|25.13||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||25.13|2.71|0.0002
72357132|NCT03192176|144229970|SUPERIORITY||Odds Ratio (OR)|3.04||||0.0149|TWO_SIDED|95.0|1.24|7.45||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||7.45|1.24|0.0149
72357133|NCT03192176|144229970|SUPERIORITY||Odds Ratio (OR)|4.65||||0.0011|TWO_SIDED|95.0|1.85|11.73||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||11.73|1.85|0.0011
72357134|NCT03192176|144229970|SUPERIORITY||Odds Ratio (OR)|6.36||||0.0001|TWO_SIDED|95.0|2.46|16.45||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||16.45|2.46|0.0001
72357135|NCT03192176|144229970|SUPERIORITY||Odds Ratio (OR)|6.87||||0.0001|TWO_SIDED|95.0|2.56|18.46||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||18.46|2.56|0.0001
72357136|NCT03192176|144229970|SUPERIORITY||Odds Ratio (OR)|2.18||||0.0897|TWO_SIDED|95.0|0.89|5.34||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||5.34|0.89|0.0897
72357137|NCT03192176|144229970|SUPERIORITY||Odds Ratio (OR)|3.46||||0.007|TWO_SIDED|95.0|1.42|8.53||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||8.53|1.42|0.0070
72357138|NCT03192176|144229970|SUPERIORITY||Odds Ratio (OR)|3.75||||0.0041|TWO_SIDED|95.0|1.52|9.23||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||9.23|1.52|0.0041
72357139|NCT03192176|144229970|SUPERIORITY||Odds Ratio (OR)|2.77||||0.0254|TWO_SIDED|95.0|1.13|6.78||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||6.78|1.13|0.0254
72357140|NCT03192176|144229970|SUPERIORITY||Odds Ratio (OR)|4.0||||0.0032|TWO_SIDED|95.0|1.59|10.04||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||10.04|1.59|0.0032
72357141|NCT03192176|144229970|SUPERIORITY||Odds Ratio (OR)|6.25||||0.0002|TWO_SIDED|95.0|2.37|16.51||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||16.51|2.37|0.0002
72357142|NCT03192176|144229970|SUPERIORITY||Odds Ratio (OR)|8.78|||<|0.0001|TWO_SIDED|95.0|3.0|25.7||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||25.70|3.00|<0.0001
72357143|NCT03192176|144229970|SUPERIORITY||Odds Ratio (OR)|2.9||||0.0214|TWO_SIDED|95.0|1.17|7.18||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||7.18|1.17|0.0214
72357144|NCT03192176|144229970|SUPERIORITY||Odds Ratio (OR)|3.67||||0.0049|TWO_SIDED|95.0|1.48|9.09||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||9.09|1.48|0.0049
72357145|NCT03192176|144229970|SUPERIORITY||Odds Ratio (OR)|3.36||||0.0078|TWO_SIDED|95.0|1.38|8.22||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||8.22|1.38|0.0078
72357146|NCT03192176|144229970|SUPERIORITY||Odds Ratio (OR)|2.28||||0.0727|TWO_SIDED|95.0|0.93|5.63||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||5.63|0.93|0.0727
72357147|NCT03192176|144229970|SUPERIORITY||Odds Ratio (OR)|2.94||||0.0199|TWO_SIDED|95.0|1.19|7.29||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||7.29|1.19|0.0199
72357148|NCT03192176|144229970|SUPERIORITY||Odds Ratio (OR)|4.21||||0.0034|TWO_SIDED|95.0|1.61|11.01||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||11.01|1.61|0.0034
72357149|NCT03192176|144229970|SUPERIORITY||Odds Ratio (OR)|6.26||||0.0007|TWO_SIDED|95.0|2.16|18.26||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||18.26|2.16|0.0007
72357150|NCT03192176|144229970|SUPERIORITY||Odds Ratio (OR)|2.02||||0.1206|TWO_SIDED|95.0|0.83|4.92||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||4.92|0.83|0.1206
72357151|NCT03192176|144229970|SUPERIORITY||Odds Ratio (OR)|3.58||||0.007|TWO_SIDED|95.0|1.42|9.03||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||9.03|1.42|0.0070
72357152|NCT03192176|144229970|SUPERIORITY||Odds Ratio (OR)|3.41||||0.0088|TWO_SIDED|95.0|1.36|8.54||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||8.54|1.36|0.0088
72357153|NCT03192176|144229970|SUPERIORITY||Odds Ratio (OR)|1.41||||0.4485|TWO_SIDED|95.0|0.58|3.4||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||3.40|0.58|0.4485
72357154|NCT03192176|144229970|SUPERIORITY||Odds Ratio (OR)|2.92||||0.0255|TWO_SIDED|95.0|1.14|7.47||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||7.47|1.14|0.0255
72357155|NCT03192176|144229970|SUPERIORITY||Odds Ratio (OR)|4.18||||0.0066|TWO_SIDED|95.0|1.49|11.75||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||11.75|1.49|0.0066
72357156|NCT03192176|144229970|SUPERIORITY||Odds Ratio (OR)|4.46||||0.0061|TWO_SIDED|95.0|1.53|13.01||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||13.01|1.53|0.0061
72357157|NCT03192176|144229970|SUPERIORITY||Odds Ratio (OR)|2.22||||0.0879|TWO_SIDED|95.0|0.89|5.57||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||5.57|0.89|0.0879
72357158|NCT03192176|144229970|SUPERIORITY||Odds Ratio (OR)|2.68||||0.0389|TWO_SIDED|95.0|1.05|6.83||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||6.83|1.05|0.0389
72357159|NCT03192176|144229970|SUPERIORITY||Odds Ratio (OR)|2.62||||0.0446|TWO_SIDED|95.0|1.02|6.73||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||6.73|1.02|0.0446
72357160|NCT03192176|144229970|SUPERIORITY||Odds Ratio (OR)|1.11||||0.8196|TWO_SIDED|95.0|0.45|2.72||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||2.72|0.45|0.8196
72357161|NCT03192176|144229970|SUPERIORITY||Odds Ratio (OR)|2.0||||0.145|TWO_SIDED|95.0|0.79|5.1||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||5.10|0.79|0.1450
72357162|NCT03192176|144229970|SUPERIORITY||Odds Ratio (OR)|4.08||||0.0114|TWO_SIDED|95.0|1.37|12.11||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||12.11|1.37|0.0114
72357163|NCT03192176|144229970|SUPERIORITY||Odds Ratio (OR)|3.29||||0.0307|TWO_SIDED|95.0|1.12|9.71||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||9.71|1.12|0.0307
72357164|NCT03192176|144229970|SUPERIORITY||Odds Ratio (OR)|1.29||||0.5921|TWO_SIDED|95.0|0.51|3.24||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||3.24|0.51|0.5921
72357165|NCT03192176|144229970|SUPERIORITY||Odds Ratio (OR)|2.69||||0.0502|TWO_SIDED|95.0|1.0|7.26||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||7.26|1.00|0.0502
72357166|NCT03192176|144229970|SUPERIORITY||Odds Ratio (OR)|3.31||||0.0224|TWO_SIDED|95.0|1.18|9.25||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||9.25|1.18|0.0224
72357167|NCT03192176|144229970|SUPERIORITY||Odds Ratio (OR)|1.18||||0.7225|TWO_SIDED|95.0|0.47|2.93||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||2.93|0.47|0.7225
72357168|NCT03192176|144229970|SUPERIORITY||Odds Ratio (OR)|2.43||||0.0762|TWO_SIDED|95.0|0.91|6.48||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||6.48|0.91|0.0762
72357169|NCT03192176|144229970|SUPERIORITY||Odds Ratio (OR)|3.51||||0.0252|TWO_SIDED|95.0|1.17|10.53||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||10.53|1.17|0.0252
72357170|NCT03192176|144229970|SUPERIORITY||Odds Ratio (OR)|2.98||||0.049|TWO_SIDED|95.0|1.0|8.87||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||8.87|1.00|0.0490
72357171|NCT03192176|144229970|SUPERIORITY||Odds Ratio (OR)|1.97||||0.1773|TWO_SIDED|95.0|0.74|5.3||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||5.30|0.74|0.1773
72357172|NCT03192176|144229970|SUPERIORITY||Odds Ratio (OR)|2.62||||0.0609|TWO_SIDED|95.0|0.96|7.16||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||7.16|0.96|0.0609
72357173|NCT03192176|144229970|SUPERIORITY||Odds Ratio (OR)|2.11||||0.1364|TWO_SIDED|95.0|0.79|5.61||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||5.61|0.79|0.1364
72357174|NCT03192176|144229970|SUPERIORITY||Odds Ratio (OR)|1.36||||0.5268|TWO_SIDED|95.0|0.53|3.51||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||3.51|0.53|0.5268
72357175|NCT03192176|144229970|SUPERIORITY||Odds Ratio (OR)|2.02||||0.1645|TWO_SIDED|95.0|0.75|5.46||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||5.46|0.75|0.1645
72357176|NCT03192176|144229970|SUPERIORITY||Odds Ratio (OR)|3.92||||0.0215|TWO_SIDED|95.0|1.22|12.57||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||12.57|1.22|0.0215
72357177|NCT03192176|144229970|SUPERIORITY||Odds Ratio (OR)|3.04||||0.06|TWO_SIDED|95.0|0.95|9.69||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||9.69|0.95|0.0600
72357178|NCT03192176|144229970|SUPERIORITY||Odds Ratio (OR)|1.25||||0.6503|TWO_SIDED|95.0|0.47|3.32||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||3.32|0.47|0.6503
72357179|NCT03192176|144229970|SUPERIORITY||Odds Ratio (OR)|2.7||||0.0683|TWO_SIDED|95.0|0.93|7.88||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||7.88|0.93|0.0683
72357180|NCT03192176|144229970|SUPERIORITY||Odds Ratio (OR)|2.83||||0.0618|TWO_SIDED|95.0|0.95|8.44||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||8.44|0.95|0.0618
72357181|NCT03192176|144229970|SUPERIORITY||Odds Ratio (OR)|1.34||||0.5621|TWO_SIDED|95.0|0.5|3.63||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||3.63|0.50|0.5621
72357182|NCT03192176|144229970|SUPERIORITY||Odds Ratio (OR)|1.92||||0.2182|TWO_SIDED|95.0|0.68|5.4||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||5.40|0.68|0.2182
72357183|NCT03192176|144229970|SUPERIORITY||Odds Ratio (OR)|3.11||||0.06|TWO_SIDED|95.0|0.95|10.15||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||10.15|0.95|0.0600
72357184|NCT03192176|144229970|SUPERIORITY||Odds Ratio (OR)|4.6||||0.029|TWO_SIDED|95.0|1.17|18.12||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||18.12|1.17|0.0290
72357185|NCT03192176|144229970|SUPERIORITY||Odds Ratio (OR)|1.1||||0.8485|TWO_SIDED|95.0|0.4|3.04||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||3.04|0.40|0.8485
72357186|NCT03192176|144229970|SUPERIORITY||Odds Ratio (OR)|2.16||||0.1652|TWO_SIDED|95.0|0.73|6.42||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||6.42|0.73|0.1652
72357187|NCT03192176|144229970|SUPERIORITY||Odds Ratio (OR)|1.94||||0.2244|TWO_SIDED|95.0|0.67|5.65||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||5.65|0.67|0.2244
72357188|NCT03192176|144229970|SUPERIORITY||Odds Ratio (OR)|1.85||||0.2097|TWO_SIDED|95.0|0.71|4.84||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||4.84|0.71|0.2097
72357189|NCT03192176|144229970|SUPERIORITY||Odds Ratio (OR)|1.53||||0.3708|TWO_SIDED|95.0|0.6|3.92||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||3.92|0.60|0.3708
72357190|NCT03192176|144229970|SUPERIORITY||Odds Ratio (OR)|2.66||||0.0704|TWO_SIDED|95.0|0.92|7.66||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||7.66|0.92|0.0704
72357191|NCT03192176|144229970|SUPERIORITY||Odds Ratio (OR)|7.21||||0.004|TWO_SIDED|95.0|1.88|27.73||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||27.73|1.88|0.0040
72357192|NCT03192176|144229970|SUPERIORITY||Odds Ratio (OR)|2.04||||0.1625|TWO_SIDED|95.0|0.75|5.55||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||5.55|0.75|0.1625
72357193|NCT03192176|144229970|SUPERIORITY||Odds Ratio (OR)|4.59||||0.0093|TWO_SIDED|95.0|1.46|14.5||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||14.50|1.46|0.0093
72357194|NCT03192176|144229970|SUPERIORITY||Odds Ratio (OR)|4.44||||0.0103|TWO_SIDED|95.0|1.42|13.87||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||13.87|1.42|0.0103
72357195|NCT03192176|144229970|SUPERIORITY||Odds Ratio (OR)|1.89||||0.1965|TWO_SIDED|95.0|0.72|4.95||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||4.95|0.72|0.1965
72357196|NCT03192176|144229970|SUPERIORITY||Odds Ratio (OR)|2.69||||0.0549|TWO_SIDED|95.0|0.98|7.42||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||7.42|0.98|0.0549
72357197|NCT03192176|144229970|SUPERIORITY||Odds Ratio (OR)|3.01||||0.0503|TWO_SIDED|95.0|1.0|9.09||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||9.09|1.00|0.0503
72357198|NCT03192176|144229970|SUPERIORITY||Odds Ratio (OR)|7.03||||0.0046|TWO_SIDED|95.0|1.82|27.1||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||27.10|1.82|0.0046
72357199|NCT03192176|144229970|SUPERIORITY||Odds Ratio (OR)|2.46||||0.0866|TWO_SIDED|95.0|0.88|6.88||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||6.88|0.88|0.0866
72357200|NCT03192176|144229970|SUPERIORITY||Odds Ratio (OR)|5.96||||0.0045|TWO_SIDED|95.0|1.74|20.4||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||20.40|1.74|0.0045
72357201|NCT03192176|144229970|SUPERIORITY||Odds Ratio (OR)|3.59||||0.0207|TWO_SIDED|95.0|1.22|10.62||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||10.62|1.22|0.0207
72357202|NCT03192176|144229970|SUPERIORITY||Odds Ratio (OR)|1.86||||0.2127|TWO_SIDED|95.0|0.7|4.91||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||4.91|0.70|0.2127
72357203|NCT03192176|144229970|SUPERIORITY||Odds Ratio (OR)|2.04||||0.1521|TWO_SIDED|95.0|0.77|5.43||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||5.43|0.77|0.1521
72357204|NCT03192176|144229970|SUPERIORITY||Odds Ratio (OR)|5.12||||0.0098|TWO_SIDED|95.0|1.48|17.7||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||17.70|1.48|0.0098
72357205|NCT03192176|144229970|SUPERIORITY||Odds Ratio (OR)|7.08||||0.0047|TWO_SIDED|95.0|1.82|27.5||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||27.50|1.82|0.0047
72357206|NCT03192176|144229970|SUPERIORITY||Odds Ratio (OR)|2.0||||0.1817|TWO_SIDED|95.0|0.72|5.51||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||5.51|0.72|0.1817
72357207|NCT03192176|144229970|SUPERIORITY||Odds Ratio (OR)|6.09||||0.0042|TWO_SIDED|95.0|1.77|20.95||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||20.95|1.77|0.0042
72357208|NCT03192176|144229970|SUPERIORITY||Odds Ratio (OR)|6.09||||0.0039|TWO_SIDED|95.0|1.78|20.74||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||20.74|1.78|0.0039
72357209|NCT03192176|144229970|SUPERIORITY||Odds Ratio (OR)|1.23||||0.7025|TWO_SIDED|95.0|0.42|3.57||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||3.57|0.42|0.7025
72357210|NCT03192176|144229970|SUPERIORITY||Odds Ratio (OR)|1.03||||0.9599|TWO_SIDED|95.0|0.36|2.97||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||2.97|0.36|0.9599
72357211|NCT03192176|144229970|SUPERIORITY||Odds Ratio (OR)|1.02||||0.9671|TWO_SIDED|95.0|0.34|3.1||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||3.10|0.34|0.9671
72357212|NCT03192176|144229970|SUPERIORITY||Odds Ratio (OR)|1.26||||0.681|TWO_SIDED|95.0|0.42|3.83||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||3.83|0.42|0.6810
72357213|NCT03192176|144229970|SUPERIORITY||Odds Ratio (OR)|1.31||||0.6346|TWO_SIDED|95.0|0.43|4.04||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||4.04|0.43|0.6346
72357214|NCT03192176|144229970|SUPERIORITY||Odds Ratio (OR)|1.16||||0.7929|TWO_SIDED|95.0|0.38|3.57||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||3.57|0.38|0.7929
72357215|NCT03192176|144229970|SUPERIORITY||Odds Ratio (OR)|1.13||||0.8188|TWO_SIDED|95.0|0.39|3.28||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||3.28|0.39|0.8188
72357216|NCT03192176|144229970|SUPERIORITY||Odds Ratio (OR)|0.88||||0.8226|TWO_SIDED|95.0|0.3|2.6||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||2.60|0.30|0.8226
72357217|NCT03192176|144229970|SUPERIORITY||Odds Ratio (OR)|0.94||||0.9088|TWO_SIDED|95.0|0.32|2.72||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||2.72|0.32|0.9088
72357218|NCT03192176|144229970|SUPERIORITY||Odds Ratio (OR)|0.75||||0.6189|TWO_SIDED|95.0|0.24|2.35||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||2.35|0.24|0.6189
72357219|NCT03192176|144229970|SUPERIORITY||Odds Ratio (OR)|1.3||||0.6463|TWO_SIDED|95.0|0.42|4.03||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||4.03|0.42|0.6463
72357220|NCT03192176|144229970|SUPERIORITY||Odds Ratio (OR)|1.47||||0.506|TWO_SIDED|95.0|0.47|4.54||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||4.54|0.47|0.5060
72357221|NCT03192176|144229970|SUPERIORITY||Odds Ratio (OR)|1.67||||0.3842|TWO_SIDED|95.0|0.53|5.31||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||5.31|0.53|0.3842
72357222|NCT03192176|144229970|SUPERIORITY||Odds Ratio (OR)|1.44||||0.5021|TWO_SIDED|95.0|0.49|4.23||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||4.23|0.49|0.5021
72357223|NCT03192176|144229970|SUPERIORITY||Odds Ratio (OR)|0.42||||0.1349|TWO_SIDED|95.0|0.14|1.31||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||1.31|0.14|0.1349
72357224|NCT03192176|144229970|SUPERIORITY||Odds Ratio (OR)|0.57||||0.3191|TWO_SIDED|95.0|0.19|1.71||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||1.71|0.19|0.3191
72357225|NCT03192176|144229970|SUPERIORITY||Odds Ratio (OR)|0.3||||0.0623|TWO_SIDED|95.0|0.09|1.06||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||1.06|0.09|0.0623
72357226|NCT03192176|144229970|SUPERIORITY||Odds Ratio (OR)|0.47||||0.1958|TWO_SIDED|95.0|0.15|1.48||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||1.48|0.15|0.1958
72357227|NCT03192176|144229970|SUPERIORITY||Odds Ratio (OR)|0.62||||0.4353|TWO_SIDED|95.0|0.19|2.05||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||2.05|0.19|0.4353
72357228|NCT03192176|144229970|SUPERIORITY||Odds Ratio (OR)|1.02||||0.9729|TWO_SIDED|95.0|0.31|3.31||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||3.31|0.31|0.9729
72357229|NCT03192176|144229970|SUPERIORITY||Odds Ratio (OR)|0.64||||0.4211|TWO_SIDED|95.0|0.22|1.89||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||1.89|0.22|0.4211
72357230|NCT03192176|144229971|SUPERIORITY||Odds Ratio (OR)|3.05||||0.1938|TWO_SIDED|95.0|0.57|16.35||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||16.35|0.57|0.1938
72357231|NCT03192176|144229971|SUPERIORITY||Odds Ratio (OR)|6.97||||0.0162|TWO_SIDED|95.0|1.43|33.91||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||33.91|1.43|0.0162
72357232|NCT03192176|144229971|SUPERIORITY||Odds Ratio (OR)|14.37||||0.0008|TWO_SIDED|95.0|3.04|67.96||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||67.96|3.04|0.0008
72357233|NCT03192176|144229971|SUPERIORITY||Odds Ratio (OR)|16.02||||0.0005|TWO_SIDED|95.0|3.39|75.68||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||75.68|3.39|0.0005
72357234|NCT03192176|144229971|SUPERIORITY||Odds Ratio (OR)|3.02||||0.1971|TWO_SIDED|95.0|0.56|16.17||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||16.17|0.56|0.1971
72357235|NCT03192176|144229971|SUPERIORITY||Odds Ratio (OR)|4.31||||0.0811|TWO_SIDED|95.0|0.83|22.27||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||22.27|0.83|0.0811
72357236|NCT03192176|144229971|SUPERIORITY||Odds Ratio (OR)|11.44||||0.0021|TWO_SIDED|95.0|2.43|53.94||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||53.94|2.43|0.0021
72357237|NCT03192176|144229971|SUPERIORITY||Odds Ratio (OR)|2.11||||0.137|TWO_SIDED|95.0|0.79|5.64||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||5.64|0.79|0.1370
72357238|NCT03192176|144229971|SUPERIORITY||Odds Ratio (OR)|3.2||||0.0181|TWO_SIDED|95.0|1.22|8.4||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||8.40|1.22|0.0181
72357239|NCT03192176|144229971|SUPERIORITY||Odds Ratio (OR)|6.43||||0.0002|TWO_SIDED|95.0|2.43|17.05||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||17.05|2.43|0.0002
72357240|NCT03192176|144229971|SUPERIORITY||Odds Ratio (OR)|6.08||||0.0003|TWO_SIDED|95.0|2.26|16.31||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||16.31|2.26|0.0003
72357241|NCT03192176|144229971|SUPERIORITY||Odds Ratio (OR)|1.65||||0.3241|TWO_SIDED|95.0|0.61|4.49||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||4.49|0.61|0.3241
72357242|NCT03192176|144229971|SUPERIORITY||Odds Ratio (OR)|1.85||||0.2249|TWO_SIDED|95.0|0.68|5.03||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||5.03|0.68|0.2249
72357243|NCT03192176|144229971|SUPERIORITY||Odds Ratio (OR)|3.53||||0.0096|TWO_SIDED|95.0|1.36|9.18||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||9.18|1.36|0.0096
72357244|NCT03192176|144229971|SUPERIORITY||Odds Ratio (OR)|2.35||||0.0768|TWO_SIDED|95.0|0.91|6.05||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||6.05|0.91|0.0768
72357245|NCT03192176|144229971|SUPERIORITY||Odds Ratio (OR)|2.91||||0.00251|TWO_SIDED|95.0|1.14|7.39||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||7.39|1.14|0.00251
72357246|NCT03192176|144229971|SUPERIORITY||Odds Ratio (OR)|5.99||||0.0002|TWO_SIDED|95.0|2.3|15.57||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||15.57|2.30|0.0002
72357247|NCT03192176|144229971|SUPERIORITY||Odds Ratio (OR)|7.29|||<|0.0001|TWO_SIDED|95.0|2.7|19.71||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||19.71|2.70|<0.0001
72357248|NCT03192176|144229971|SUPERIORITY||Odds Ratio (OR)|2.14||||0.1144|TWO_SIDED|95.0|0.83|5.5||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||5.50|0.83|0.1144
72357249|NCT03192176|144229971|SUPERIORITY||Odds Ratio (OR)|2.06||||0.1341|TWO_SIDED|95.0|0.8|5.3||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||5.30|0.80|0.1341
72357250|NCT03192176|144229971|SUPERIORITY||Odds Ratio (OR)|4.43||||0.0017|TWO_SIDED|95.0|1.75|11.22||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||11.22|1.75|0.0017
72357251|NCT03192176|144229971|SUPERIORITY||Odds Ratio (OR)|2.06||||0.1488|TWO_SIDED|95.0|0.77|5.5||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||5.50|0.77|0.1488
72357252|NCT03192176|144229971|SUPERIORITY||Odds Ratio (OR)|3.99||||0.0043|TWO_SIDED|95.0|1.54|10.3||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||10.30|1.54|0.0043
72357253|NCT03192176|144229971|SUPERIORITY||Odds Ratio (OR)|5.53||||0.0005|TWO_SIDED|95.0|2.1|14.57||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||14.57|2.10|0.0005
72357254|NCT03192176|144229971|SUPERIORITY||Odds Ratio (OR)|14.54|||<|0.0001|TWO_SIDED|95.0|4.85|43.58||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||43.58|4.85|<0.0001
72357255|NCT03192176|144229971|SUPERIORITY||Odds Ratio (OR)|2.96||||0.0262|TWO_SIDED|95.0|1.14|7.68||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||7.68|1.14|0.0262
72357256|NCT03192176|144229971|SUPERIORITY||Odds Ratio (OR)|5.07||||0.0009|TWO_SIDED|95.0|1.95|13.19||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||13.19|1.95|0.0009
72357257|NCT03192176|144229971|SUPERIORITY||Odds Ratio (OR)|5.33||||0.0006|TWO_SIDED|95.0|2.06|13.8||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||13.80|2.06|0.0006
72357258|NCT03192176|144229971|SUPERIORITY||Odds Ratio (OR)|1.52||||0.3673|TWO_SIDED|95.0|0.61|3.75||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||3.75|0.61|0.3673
72357259|NCT03192176|144229971|SUPERIORITY||Odds Ratio (OR)|2.02||||0.1207|TWO_SIDED|95.0|0.83|4.91||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||4.91|0.83|0.1207
72357260|NCT03192176|144229971|SUPERIORITY||Odds Ratio (OR)|5.01||||0.0011|TWO_SIDED|95.0|1.9|13.21||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||13.21|1.90|0.0011
72357261|NCT03192176|144229971|SUPERIORITY||Odds Ratio (OR)|9.19|||<|0.0001|TWO_SIDED|95.0|3.08|27.38||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||27.38|3.08|<0.0001
72357262|NCT03192176|144229971|SUPERIORITY||Odds Ratio (OR)|2.38||||0.0594|TWO_SIDED|95.0|0.97|5.86||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||5.86|0.97|0.0594
72357263|NCT03192176|144229971|SUPERIORITY||Odds Ratio (OR)|2.47||||0.05|TWO_SIDED|95.0|1.0|6.09||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||6.09|1.00|0.0500
72357264|NCT03192176|144229971|SUPERIORITY||Odds Ratio (OR)|3.22||||0.0123|TWO_SIDED|95.0|1.29|8.03||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||8.03|1.29|0.0123
72357265|NCT03192176|144229971|SUPERIORITY||Odds Ratio (OR)|1.76||||0.2243|TWO_SIDED|95.0|0.71|4.37||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||4.37|0.71|0.2243
72357266|NCT03192176|144229971|SUPERIORITY||Odds Ratio (OR)|2.13||||0.0976|TWO_SIDED|95.0|0.87|5.24||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||5.24|0.87|0.0976
72357267|NCT03192176|144229971|SUPERIORITY||Odds Ratio (OR)|6.09||||0.0004|TWO_SIDED|95.0|2.25|16.44||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||16.44|2.25|0.0004
72357268|NCT03192176|144229971|SUPERIORITY||Odds Ratio (OR)|9.13|||<|0.0001|TWO_SIDED|95.0|3.04|27.4||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||27.40|3.04|<0.0001
72357269|NCT03192176|144229971|SUPERIORITY||Odds Ratio (OR)|2.06||||0.1237|TWO_SIDED|95.0|0.82|5.17||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||5.17|0.82|0.1237
72357270|NCT03192176|144229971|SUPERIORITY||Odds Ratio (OR)|2.94||||0.0226|TWO_SIDED|95.0|1.16|7.41||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||7.41|1.16|0.0226
72357271|NCT03192176|144229971|SUPERIORITY||Odds Ratio (OR)|3.55||||0.0069|TWO_SIDED|95.0|1.42|8.91||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||8.91|1.42|0.0069
72357272|NCT03192176|144229971|SUPERIORITY||Odds Ratio (OR)|1.9||||0.1666|TWO_SIDED|95.0|0.76|4.75||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||4.75|0.76|0.1666
72357273|NCT03192176|144229971|SUPERIORITY||Odds Ratio (OR)|2.7||||0.0317|TWO_SIDED|95.0|1.09|6.67||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||6.67|1.09|0.0317
72357274|NCT03192176|144229971|SUPERIORITY||Odds Ratio (OR)|5.28||||0.0011|TWO_SIDED|95.0|1.94|14.39||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||14.39|1.94|0.0011
72357275|NCT03192176|144229971|SUPERIORITY||Odds Ratio (OR)|8.45||||0.0001|TWO_SIDED|95.0|2.81|25.46||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||25.46|2.81|0.0001
72357276|NCT03192176|144229971|SUPERIORITY||Odds Ratio (OR)|2.1||||0.1142|TWO_SIDED|95.0|0.84|5.27||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||5.27|0.84|0.1142
72357277|NCT03192176|144229971|SUPERIORITY||Odds Ratio (OR)|2.91||||0.025|TWO_SIDED|95.0|1.14|7.39||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||7.39|1.14|0.0250
72357278|NCT03192176|144229971|SUPERIORITY||Odds Ratio (OR)|3.08||||0.0166|TWO_SIDED|95.0|1.23|7.75||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||7.75|1.23|0.0166
72357279|NCT03192176|144229971|SUPERIORITY||Odds Ratio (OR)|1.27||||0.6033|TWO_SIDED|95.0|0.52|3.11||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||3.11|0.52|0.6033
72357280|NCT03192176|144229971|SUPERIORITY||Odds Ratio (OR)|2.05||||0.117|TWO_SIDED|95.0|0.84|5.02||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||5.02|0.84|0.1170
72357281|NCT03192176|144229971|SUPERIORITY||Odds Ratio (OR)|2.69||||0.04|TWO_SIDED|95.0|1.05|6.91||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||6.91|1.05|0.0400
72357282|NCT03192176|144229971|SUPERIORITY||Odds Ratio (OR)|5.61||||0.002|TWO_SIDED|95.0|1.88|16.72||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||16.72|1.88|0.0020
72357283|NCT03192176|144229971|SUPERIORITY||Odds Ratio (OR)|1.35||||0.5177|TWO_SIDED|95.0|0.54|3.37||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||3.37|0.54|0.5177
72357284|NCT03192176|144229971|SUPERIORITY||Odds Ratio (OR)|1.79||||0.2117|TWO_SIDED|95.0|0.72|4.48||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||4.48|0.72|0.2117
72357285|NCT03192176|144229971|SUPERIORITY||Odds Ratio (OR)|2.62||||0.0426|TWO_SIDED|95.0|1.03|6.67||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||6.67|1.03|0.0426
72357286|NCT03192176|144229971|SUPERIORITY||Odds Ratio (OR)|1.54||||0.3508|TWO_SIDED|95.0|0.62|3.82||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||3.82|0.62|0.3508
72357287|NCT03192176|144229971|SUPERIORITY||Odds Ratio (OR)|1.42||||0.4431|TWO_SIDED|95.0|0.58|3.45||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||3.45|0.58|0.4431
72357288|NCT03192176|144229971|SUPERIORITY||Odds Ratio (OR)|4.27||||0.005|TWO_SIDED|95.0|1.55|11.78||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||11.78|1.55|0.0050
72357289|NCT03192176|144229971|SUPERIORITY||Odds Ratio (OR)|5.47||||0.0023|TWO_SIDED|95.0|1.84|16.3||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||16.30|1.84|0.0023
72357290|NCT03192176|144229971|SUPERIORITY||Odds Ratio (OR)|1.31||||0.5663|TWO_SIDED|95.0|0.52|3.32||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||3.32|0.52|0.5663
72357291|NCT03192176|144229971|SUPERIORITY||Odds Ratio (OR)|2.64||||0.0461|TWO_SIDED|95.0|1.02|6.83||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||6.83|1.02|0.0461
72357292|NCT03192176|144229971|SUPERIORITY||Odds Ratio (OR)|2.5||||0.0552|TWO_SIDED|95.0|0.98|6.38||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||6.38|0.98|0.0552
72357293|NCT03192176|144229971|SUPERIORITY||Odds Ratio (OR)|1.95||||0.1536|TWO_SIDED|95.0|0.78|4.88||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||4.88|0.78|0.1536
72357294|NCT03192176|144229971|SUPERIORITY||Odds Ratio (OR)|1.69||||0.2575|TWO_SIDED|95.0|0.68|4.2||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||4.20|0.68|0.2575
72357295|NCT03192176|144229971|SUPERIORITY||Odds Ratio (OR)|3.73||||0.0096|TWO_SIDED|95.0|1.38|10.11||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||10.11|1.38|0.0096
72357296|NCT03192176|144229971|SUPERIORITY||Odds Ratio (OR)|8.48||||0.0003|TWO_SIDED|95.0|2.69|26.76||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||26.76|2.69|0.0003
72357297|NCT03192176|144229971|SUPERIORITY||Odds Ratio (OR)|2.18||||0.1047|TWO_SIDED|95.0|1.48|10.35||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||10.35|1.48|0.1047
72357298|NCT03192176|144229971|SUPERIORITY||Odds Ratio (OR)|3.91||||0.006|TWO_SIDED|95.0|1.48|10.35||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||10.35|1.48|0.0060
72357299|NCT03192176|144229971|SUPERIORITY||Odds Ratio (OR)|2.64||||0.0414|TWO_SIDED|95.0|1.04|6.71||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||6.71|1.04|0.0414
72357300|NCT03192176|144229971|SUPERIORITY||Odds Ratio (OR)|2.31||||0.0809|TWO_SIDED|95.0|0.9|5.89||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||5.89|0.90|0.0809
72357301|NCT03192176|144229971|SUPERIORITY||Odds Ratio (OR)|1.74||||0.2377|TWO_SIDED|95.0|0.69|4.34||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||4.34|0.69|0.2377
72357302|NCT03192176|144229971|SUPERIORITY||Odds Ratio (OR)|4.21||||0.0087|TWO_SIDED|95.0|1.44|12.34||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||12.34|1.44|0.0087
72357303|NCT03192176|144229971|SUPERIORITY||Odds Ratio (OR)|6.0||||0.0022|TWO_SIDED|95.0|1.9|18.94||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||18.94|1.90|0.0022
72357304|NCT03192176|144229971|SUPERIORITY||Odds Ratio (OR)|1.4||||0.4788|TWO_SIDED|95.0|0.55|3.55||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||3.55|0.55|0.4788
72357305|NCT03192176|144229971|SUPERIORITY||Odds Ratio (OR)|3.98||||0.0074|TWO_SIDED|95.0|1.45|10.94||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||10.94|1.45|0.0074
72357306|NCT03192176|144229971|SUPERIORITY||Odds Ratio (OR)|3.26||||0.0187|TWO_SIDED|95.0|1.22|8.75||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||8.75|1.22|0.0187
72357307|NCT03192176|144229971|SUPERIORITY||Odds Ratio (OR)|1.57||||0.3443|TWO_SIDED|95.0|0.62|4.0||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||4.00|0.62|0.3443
72357308|NCT03192176|144229971|SUPERIORITY||Odds Ratio (OR)|1.66||||0.2867|TWO_SIDED|95.0|0.65|4.22||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||4.22|0.65|0.2867
72357309|NCT03192176|144229971|SUPERIORITY||Odds Ratio (OR)|5.12||||0.0044|TWO_SIDED|95.0|1.66|15.78||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||15.78|1.66|0.0044
72357310|NCT03192176|144229971|SUPERIORITY||Odds Ratio (OR)|5.58||||0.0038|TWO_SIDED|95.0|1.74|17.87||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||17.87|1.74|0.0038
72357311|NCT03192176|144229971|SUPERIORITY||Odds Ratio (OR)|2.09||||0.1424|TWO_SIDED|95.0|0.78|5.6||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||5.60|0.78|0.1424
72357312|NCT03192176|144229971|SUPERIORITY||Odds Ratio (OR)|3.32||||0.0191|TWO_SIDED|95.0|1.22|9.07||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||9.07|1.22|0.0191
72357313|NCT03192176|144229971|SUPERIORITY||Odds Ratio (OR)|3.15||||0.0244|TWO_SIDED|95.0|1.16|8.56||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||8.56|1.16|0.0244
72357314|NCT03192176|144229971|SUPERIORITY||Odds Ratio (OR)|2.63||||0.1462|TWO_SIDED|95.0|0.71|9.67||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||9.67|0.71|0.1462
72357315|NCT03192176|144229971|SUPERIORITY||Odds Ratio (OR)|1.26||||0.7403|TWO_SIDED|95.0|0.32|4.97||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||4.97|0.32|0.7403
72357316|NCT03192176|144229971|SUPERIORITY||Odds Ratio (OR)|2.35||||0.2144|TWO_SIDED|95.0|0.61|9.07||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||9.07|0.61|0.2144
72357317|NCT03192176|144229971|SUPERIORITY||Odds Ratio (OR)|1.74||||0.4321|TWO_SIDED|95.0|0.44|6.96||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||6.96|0.44|0.4321
72357318|NCT03192176|144229971|SUPERIORITY||Odds Ratio (OR)|2.53||||0.1778|TWO_SIDED|95.0|0.66|9.75||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||9.75|0.66|0.1778
72357319|NCT03192176|144229971|SUPERIORITY||Odds Ratio (OR)|1.21||||0.8016|TWO_SIDED|95.0|0.28|5.2||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||5.20|0.28|0.8016
72357320|NCT03192176|144229971|SUPERIORITY||Odds Ratio (OR)|2.62||||0.1486|TWO_SIDED|95.0|0.71|9.64||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||9.64|0.71|0.1486
72357321|NCT03192176|144229971|SUPERIORITY||Odds Ratio (OR)|0.51||||0.2881|TWO_SIDED|95.0|0.15|1.77||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||1.77|0.15|0.2881
72357322|NCT03192176|144229971|SUPERIORITY||Odds Ratio (OR)|0.36||||0.1217|TWO_SIDED|95.0|0.1|1.31||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||1.31|0.10|0.1217
72357323|NCT03192176|144229971|SUPERIORITY||Odds Ratio (OR)|0.36||||0.1027|TWO_SIDED|95.0|0.07|1.28||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||1.28|0.07|0.1027
72357324|NCT03192176|144229971|SUPERIORITY||Odds Ratio (OR)|0.18||||0.0428|TWO_SIDED|95.0|0.03|0.94||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||0.94|0.03|0.0428
72357325|NCT03192176|144229971|SUPERIORITY||Odds Ratio (OR)|0.72||||0.5943|TWO_SIDED|95.0|0.21|2.44||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||2.44|0.21|0.5943
72357326|NCT03192176|144229971|SUPERIORITY||Odds Ratio (OR)|0.94||||0.928|TWO_SIDED|95.0|0.27|3.28||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||3.28|0.27|0.9280
72357327|NCT03192176|144229971|SUPERIORITY||Odds Ratio (OR)|0.94||||0.916|TWO_SIDED|95.0|0.3|2.94||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||2.94|0.30|0.9160
72357328|NCT03192176|144229971|SUPERIORITY||Odds Ratio (OR)|0.43||||0.2262|TWO_SIDED|95.0|0.11|1.69||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||1.69|0.11|0.2262
72357329|NCT03192176|144229971|SUPERIORITY||Odds Ratio (OR)|0.48||||0.2682|TWO_SIDED|95.0|0.13|1.75||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||1.75|0.13|0.2682
72357330|NCT03192176|144229971|SUPERIORITY||Odds Ratio (OR)|0.4||||0.2344|TWO_SIDED|95.0|0.09|1.81||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||1.81|0.09|0.2344
72357331|NCT03192176|144229971|SUPERIORITY||Odds Ratio (OR)|0.22||||0.0835|TWO_SIDED|95.0|0.04|1.22||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||1.22|0.04|0.0835
72357332|NCT03192176|144229971|SUPERIORITY||Odds Ratio (OR)|0.72||||0.6322|TWO_SIDED|95.0|0.19|2.72||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||2.72|0.19|0.6322
72357333|NCT03192176|144229971|SUPERIORITY||Odds Ratio (OR)|0.65||||0.4845|TWO_SIDED|95.0|0.2|2.17||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||2.17|0.20|0.4845
72357334|NCT03192176|144229972|SUPERIORITY||Odds Ratio (OR)|1.08||||0.9587|TWO_SIDED|95.0|0.06|17.98||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||17.98|0.06|0.9587
72357335|NCT03192176|144229972|SUPERIORITY||Odds Ratio (OR)|1.02||||0.9895|TWO_SIDED|95.0|0.06|16.89||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||16.89|0.06|0.9895
72357336|NCT03192176|144229972|SUPERIORITY||Odds Ratio (OR)|7.24||||0.0736|TWO_SIDED|95.0|0.83|63.32||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||63.32|0.83|0.0736
72357337|NCT03192176|144229972|SUPERIORITY||Odds Ratio (OR)|7.08||||0.0767|TWO_SIDED|95.0|0.81|61.78||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||61.78|0.81|0.0767
72357338|NCT03192176|144229972|SUPERIORITY||Odds Ratio (OR)|3.51||||0.288|TWO_SIDED|95.0|0.35|35.49||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||35.49|0.35|0.2880
72357339|NCT03192176|144229972|SUPERIORITY||Odds Ratio (OR)|1.96||||0.5894|TWO_SIDED|95.0|0.17|22.47||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||22.47|0.17|0.5894
72357340|NCT03192176|144229972|SUPERIORITY||Odds Ratio (OR)|2.45||||0.3093|TWO_SIDED|95.0|0.44|13.78||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||13.78|0.44|0.3093
72357341|NCT03192176|144229972|SUPERIORITY||Odds Ratio (OR)|3.31||||0.1606|TWO_SIDED|95.0|0.62|17.58||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||17.58|0.62|0.1606
72357342|NCT03192176|144229972|SUPERIORITY||Odds Ratio (OR)|11.92||||0.0019|TWO_SIDED|95.0|2.5|56.87||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||56.87|2.50|0.0019
72357343|NCT03192176|144229972|SUPERIORITY||Odds Ratio (OR)|14.4||||0.0008|TWO_SIDED|95.0|3.02|68.73||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||68.73|3.02|0.0008
72357344|NCT03192176|144229972|SUPERIORITY||Odds Ratio (OR)|0.86||||0.8803|TWO_SIDED|95.0|0.11|6.55||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||6.55|0.11|0.8803
72357345|NCT03192176|144229972|SUPERIORITY||Odds Ratio (OR)|2.98||||0.2096|TWO_SIDED|95.0|0.54|16.46||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||16.46|0.54|0.2096
72357346|NCT03192176|144229972|SUPERIORITY||Odds Ratio (OR)|7.69||||0.011|TWO_SIDED|95.0|1.6|37.11||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||37.11|1.60|0.0110
72357347|NCT03192176|144229972|SUPERIORITY||Odds Ratio (OR)|3.09||||0.0845|TWO_SIDED|95.0|0.86|11.11||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||11.11|0.86|0.0845
72357348|NCT03192176|144229972|SUPERIORITY||Odds Ratio (OR)|2.83||||0.1094|TWO_SIDED|95.0|0.79|10.13||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||10.13|0.79|0.1094
72357349|NCT03192176|144229972|SUPERIORITY||Odds Ratio (OR)|8.97||||0.0004|TWO_SIDED|95.0|2.68|30.07||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||30.07|2.68|0.0004
72357350|NCT03192176|144229972|SUPERIORITY||Odds Ratio (OR)|7.11||||0.0016|TWO_SIDED|95.0|2.1|24.09||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||24.09|2.10|0.0016
72357351|NCT03192176|144229972|SUPERIORITY||Odds Ratio (OR)|1.71||||0.4375|TWO_SIDED|95.0|0.44|6.64||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||6.64|0.44|0.4375
72357352|NCT03192176|144229972|SUPERIORITY||Odds Ratio (OR)|3.02||||0.0898|TWO_SIDED|95.0|0.84|10.85||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||10.85|0.84|0.0898
72357353|NCT03192176|144229972|SUPERIORITY||Odds Ratio (OR)|6.32||||0.0027|TWO_SIDED|95.0|1.9|21.06||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||21.06|1.90|0.0027
72357354|NCT03192176|144229972|SUPERIORITY||Odds Ratio (OR)|2.44||||0.1242|TWO_SIDED|95.0|0.78|7.64||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||7.64|0.78|0.1242
72357355|NCT03192176|144229972|SUPERIORITY||Odds Ratio (OR)|2.66||||0.0815|TWO_SIDED|95.0|0.88|8.03||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||8.03|0.88|0.0815
72357356|NCT03192176|144229972|SUPERIORITY||Odds Ratio (OR)|6.21||||0.0009|TWO_SIDED|95.0|2.11|18.27||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||18.27|2.11|0.0009
72357357|NCT03192176|144229972|SUPERIORITY||Odds Ratio (OR)|5.28||||0.0027|TWO_SIDED|95.0|1.78|15.64||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||15.64|1.78|0.0027
72357358|NCT03192176|144229972|SUPERIORITY||Odds Ratio (OR)|1.35||||0.6267|TWO_SIDED|95.0|0.41|4.46||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||4.46|0.41|0.6267
72357359|NCT03192176|144229972|SUPERIORITY||Odds Ratio (OR)|2.77||||0.0709|TWO_SIDED|95.0|0.92|8.38||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||8.38|0.92|0.0709
72357360|NCT03192176|144229972|SUPERIORITY||Odds Ratio (OR)|4.62||||0.0049|TWO_SIDED|95.0|1.59|13.59||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||13.59|1.59|0.0049
72357361|NCT03192176|144229972|SUPERIORITY||Odds Ratio (OR)|1.5||||0.5107|TWO_SIDED|95.0|0.45|4.98||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||4.98|0.45|0.5107
72357362|NCT03192176|144229972|SUPERIORITY||Odds Ratio (OR)|2.37||||0.1297|TWO_SIDED|95.0|0.78|7.22||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||7.22|0.78|0.1297
72357363|NCT03192176|144229972|SUPERIORITY||Odds Ratio (OR)|7.04||||0.0005|TWO_SIDED|95.0|2.34|21.22||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||21.22|2.34|0.0005
72357364|NCT03192176|144229972|SUPERIORITY||Odds Ratio (OR)|8.5||||0.0001|TWO_SIDED|95.0|2.82|25.63||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||25.63|2.82|0.0001
72357365|NCT03192176|144229972|SUPERIORITY||Odds Ratio (OR)|1.84||||0.299|TWO_SIDED|95.0|0.58|5.81||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||5.81|0.58|0.2990
72357366|NCT03192176|144229972|SUPERIORITY||Odds Ratio (OR)|2.38||||0.1355|TWO_SIDED|95.0|0.76|7.42||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||7.42|0.76|0.1355
72357367|NCT03192176|144229972|SUPERIORITY||Odds Ratio (OR)|5.17||||0.0028|TWO_SIDED|95.0|1.76|15.14||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||15.14|1.76|0.0028
72357368|NCT03192176|144229972|SUPERIORITY||Odds Ratio (OR)|1.2||||0.7422|TWO_SIDED|95.0|0.41|3.47||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||3.47|0.41|0.7422
72357369|NCT03192176|144229972|SUPERIORITY||Odds Ratio (OR)|2.44||||0.075|TWO_SIDED|95.0|0.91|6.52||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||6.52|0.91|0.0750
72357370|NCT03192176|144229972|SUPERIORITY||Odds Ratio (OR)|6.0||||0.0006|TWO_SIDED|95.0|2.16|16.67||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||16.67|2.16|0.0006
72357371|NCT03192176|144229972|SUPERIORITY||Odds Ratio (OR)|7.63||||0.0001|TWO_SIDED|95.0|2.69|21.65||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||21.65|2.69|0.0001
72357372|NCT03192176|144229972|SUPERIORITY||Odds Ratio (OR)|1.12||||0.8405|TWO_SIDED|95.0|0.38|3.23||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||3.23|0.38|0.8405
72357373|NCT03192176|144229972|SUPERIORITY||Odds Ratio (OR)|1.3||||0.6257|TWO_SIDED|95.0|0.45|3.79||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||3.79|0.45|0.6257
72357374|NCT03192176|144229972|SUPERIORITY||Odds Ratio (OR)|3.92||||0.006|TWO_SIDED|95.0|1.48|10.36||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||10.36|1.48|0.0060
72357375|NCT03192176|144229972|SUPERIORITY||Odds Ratio (OR)|1.74||||0.3556|TWO_SIDED|95.0|0.54|5.68||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||5.68|0.54|0.3556
72357376|NCT03192176|144229972|SUPERIORITY||Odds Ratio (OR)|3.67||||0.019|TWO_SIDED|95.0|1.24|10.9||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||10.90|1.24|0.0190
72357377|NCT03192176|144229972|SUPERIORITY||Odds Ratio (OR)|9.9|||<|0.0001|TWO_SIDED|95.0|3.2|30.68||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||30.68|3.20|<0.0001
72357378|NCT03192176|144229972|SUPERIORITY||Odds Ratio (OR)|14.81|||<|0.0001|TWO_SIDED|95.0|4.67|47.05||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||47.05|4.67|<0.0001
72357379|NCT03192176|144229972|SUPERIORITY||Odds Ratio (OR)|2.13||||0.1936|TWO_SIDED|95.0|0.68|6.67||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||6.67|0.68|0.1936
72357380|NCT03192176|144229972|SUPERIORITY||Odds Ratio (OR)|3.39||||0.0335|TWO_SIDED|95.0|1.1|10.47||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||10.47|1.10|0.0335
72357381|NCT03192176|144229972|SUPERIORITY||Odds Ratio (OR)|6.18||||0.0009|TWO_SIDED|95.0|2.1|18.17||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||18.17|2.10|0.0009
72357382|NCT03192176|144229972|SUPERIORITY||Odds Ratio (OR)|0.9||||0.833|TWO_SIDED|95.0|0.34|2.39||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||2.39|0.34|0.8330
72357383|NCT03192176|144229972|SUPERIORITY||Odds Ratio (OR)|1.56||||0.341|TWO_SIDED|95.0|0.62|3.91||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||3.91|0.62|0.3410
72357384|NCT03192176|144229972|SUPERIORITY||Odds Ratio (OR)|3.71||||0.0075|TWO_SIDED|95.0|1.42|9.69||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||9.69|1.42|0.0075
72357385|NCT03192176|144229972|SUPERIORITY||Odds Ratio (OR)|4.86||||0.002|TWO_SIDED|95.0|1.78|13.26||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||13.26|1.78|0.0020
72357386|NCT03192176|144229972|SUPERIORITY||Odds Ratio (OR)|0.78||||0.6216|TWO_SIDED|95.0|0.29|2.1||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||2.10|0.29|0.6216
72357387|NCT03192176|144229972|SUPERIORITY||Odds Ratio (OR)|1.43||||0.4615|TWO_SIDED|95.0|0.55|3.71||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||3.71|0.55|0.4615
72357388|NCT03192176|144229972|SUPERIORITY||Odds Ratio (OR)|2.84||||0.0281|TWO_SIDED|95.0|1.12|7.19||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||7.19|1.12|0.0281
72357389|NCT03192176|144229972|SUPERIORITY||Odds Ratio (OR)|0.88||||0.8028|TWO_SIDED|95.0|0.33|2.35||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||2.35|0.33|0.8028
72357390|NCT03192176|144229972|SUPERIORITY||Odds Ratio (OR)|1.21||||0.6846|TWO_SIDED|95.0|0.48|3.07||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||3.07|0.48|0.6846
72357391|NCT03192176|144229972|SUPERIORITY||Odds Ratio (OR)|3.31||||0.0149|TWO_SIDED|95.0|1.26|8.67||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||8.67|1.26|0.0149
72357392|NCT03192176|144229972|SUPERIORITY||Odds Ratio (OR)|5.64||||0.0009|TWO_SIDED|95.0|2.03|15.65||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||15.65|2.03|0.0009
72357393|NCT03192176|144229972|SUPERIORITY||Odds Ratio (OR)|0.79||||0.6434|TWO_SIDED|95.0|0.29|2.15||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||2.15|0.29|0.6434
72357394|NCT03192176|144229972|SUPERIORITY||Odds Ratio (OR)|1.41||||0.4784|TWO_SIDED|95.0|0.54|3.69||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||3.69|0.54|0.4784
72357395|NCT03192176|144229972|SUPERIORITY||Odds Ratio (OR)|2.2||||0.0955|TWO_SIDED|95.0|0.87|5.55||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||5.55|0.87|0.0955
72357396|NCT03192176|144229972|SUPERIORITY||Odds Ratio (OR)|1.06||||0.9082|TWO_SIDED|95.0|0.4|2.79||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||2.79|0.40|0.9082
72357397|NCT03192176|144229972|SUPERIORITY||Odds Ratio (OR)|1.25||||0.6478|TWO_SIDED|95.0|0.48|3.21||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||3.21|0.48|0.6478
72357398|NCT03192176|144229972|SUPERIORITY||Odds Ratio (OR)|3.65||||0.0104|TWO_SIDED|95.0|1.35|9.82||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||9.82|1.35|0.0104
72357399|NCT03192176|144229972|SUPERIORITY||Odds Ratio (OR)|6.66||||0.0004|TWO_SIDED|95.0|2.34|18.94||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||18.94|2.34|0.0004
72357400|NCT03192176|144229972|SUPERIORITY||Odds Ratio (OR)|0.91||||0.856|TWO_SIDED|95.0|0.34|2.45||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||2.45|0.34|0.8560
72357401|NCT03192176|144229972|SUPERIORITY||Odds Ratio (OR)|1.6||||0.3319|TWO_SIDED|95.0|0.62|4.17||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||4.17|0.62|0.3319
72357402|NCT03192176|144229972|SUPERIORITY||Odds Ratio (OR)|2.34||||0.0747|TWO_SIDED|95.0|0.92|5.95||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||5.95|0.92|0.0747
72357403|NCT03192176|144229972|SUPERIORITY||Odds Ratio (OR)|1.06||||0.8986|TWO_SIDED|95.0|0.41|2.76||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||2.76|0.41|0.8986
72357404|NCT03192176|144229972|SUPERIORITY||Odds Ratio (OR)|0.98||||0.9712|TWO_SIDED|95.0|0.38|2.53||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||2.53|0.38|0.9712
72357405|NCT03192176|144229972|SUPERIORITY||Odds Ratio (OR)|3.31||||0.091|TWO_SIDED|95.0|1.22|8.98||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||8.98|1.22|0.0910
72357406|NCT03192176|144229972|SUPERIORITY||Odds Ratio (OR)|5.68||||0.0011|TWO_SIDED|95.0|2.01|16.06||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||16.06|2.01|0.0011
72357407|NCT03192176|144229972|SUPERIORITY||Odds Ratio (OR)|0.91||||0.8466|TWO_SIDED|95.0|0.35|2.39||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||2.39|0.35|0.8466
72357408|NCT03192176|144229972|SUPERIORITY||Odds Ratio (OR)|2.03||||0.1409|TWO_SIDED|95.0|0.79|5.21||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||5.21|0.79|0.1409
72357409|NCT03192176|144229972|SUPERIORITY||Odds Ratio (OR)|2.08||||0.1212|TWO_SIDED|95.0|0.82|5.25||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||5.25|0.82|0.1212
72357410|NCT03192176|144229972|SUPERIORITY||Odds Ratio (OR)|1.48||||0.4269|TWO_SIDED|95.0|0.56|3.88||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||3.88|0.56|0.4269
72357411|NCT03192176|144229972|SUPERIORITY||Odds Ratio (OR)|1.34||||0.5454|TWO_SIDED|95.0|0.52|3.49||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||3.49|0.52|0.5454
72357412|NCT03192176|144229972|SUPERIORITY||Odds Ratio (OR)|2.62||||0.0595|TWO_SIDED|95.0|0.96|7.15||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||7.15|0.96|0.0595
72357413|NCT03192176|144229972|SUPERIORITY||Odds Ratio (OR)|4.58||||0.0041|TWO_SIDED|95.0|1.62|12.98||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||12.98|1.62|0.0041
72357414|NCT03192176|144229972|SUPERIORITY||Odds Ratio (OR)|0.77||||0.6121|TWO_SIDED|95.0|0.28|2.13||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||2.13|0.28|0.6121
72357415|NCT03192176|144229972|SUPERIORITY||Odds Ratio (OR)|1.8||||0.2329|TWO_SIDED|95.0|0.68|4.75||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||4.75|0.68|0.2329
72357416|NCT03192176|144229972|SUPERIORITY||Odds Ratio (OR)|2.28||||0.0891|TWO_SIDED|95.0|0.88|5.9||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||5.90|0.88|0.0891
72357417|NCT03192176|144229972|SUPERIORITY||Odds Ratio (OR)|0.55||||0.6857|TWO_SIDED|95.0|0.03|9.97||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||9.97|0.03|0.6857
72357418|NCT03192176|144229972|SUPERIORITY||Odds Ratio (OR)|1.56||||0.7291|TWO_SIDED|95.0|0.12|19.71||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||19.71|0.12|0.7291
72357419|NCT03192176|144229972|SUPERIORITY||Odds Ratio (OR)|0.82||||0.8951|TWO_SIDED|95.0|0.05|14.41||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||14.41|0.05|0.8951
72357420|NCT03192176|144229972|SUPERIORITY||Odds Ratio (OR)|1.66||||0.6865|TWO_SIDED|95.0|0.14|19.74||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||19.74|0.14|0.6865
72357421|NCT03192176|144229972|SUPERIORITY||Odds Ratio (OR)|1.17||||0.9132|TWO_SIDED|95.0|0.07|20.24||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||20.24|0.07|0.9132
72357422|NCT03192176|144229972|SUPERIORITY||Odds Ratio (OR)|1.38||||0.7982|TWO_SIDED|95.0|0.12|16.59||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||16.59|0.12|0.7982
72357423|NCT03192176|144229972|SUPERIORITY||Odds Ratio (OR)|1.17||||0.9029|TWO_SIDED|95.0|0.09|15.57||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||15.57|0.09|0.9029
72357424|NCT03192176|144229972|SUPERIORITY||Odds Ratio (OR)|0.69||||0.7971|TWO_SIDED|95.0|0.04|11.94||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||11.94|0.04|0.7971
72357425|NCT03192176|144229973|SUPERIORITY||Odds Ratio (OR)|0.67||||0.7899|TWO_SIDED|95.0|0.04|12.34||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||12.34|0.04|0.7899
72357426|NCT03192176|144229973|SUPERIORITY||Odds Ratio (OR)|0.86||||0.9186|TWO_SIDED|95.0|0.05|14.73||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||14.73|0.05|0.9186
72357427|NCT03192176|144229973|SUPERIORITY||Odds Ratio (OR)|2.19||||0.5303|TWO_SIDED|95.0|0.19|25.46||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||25.46|0.19|0.5303
72357428|NCT03192176|144229973|SUPERIORITY||Odds Ratio (OR)|5.85||||0.1149|TWO_SIDED|95.0|0.65|52.66||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||52.66|0.65|0.1149
72357429|NCT03192176|144229973|SUPERIORITY||Odds Ratio (OR)|9.07||||0.0442|TWO_SIDED|95.0|1.06|77.71||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||77.71|1.06|0.0442
72357430|NCT03192176|144229973|SUPERIORITY||Odds Ratio (OR)|3.53||||0.2851|TWO_SIDED|95.0|0.35|35.68||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||35.68|0.35|0.2851
72357431|NCT03192176|144229973|SUPERIORITY||Odds Ratio (OR)|4.22||||0.2073|TWO_SIDED|95.0|0.45|39.48||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||39.48|0.45|0.2073
72357432|NCT03192176|144229973|SUPERIORITY||Odds Ratio (OR)|3.68||||0.27|TWO_SIDED|95.0|0.36|37.16||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||37.16|0.36|0.2700
72357433|NCT03192176|144229973|SUPERIORITY||Odds Ratio (OR)|3.41||||0.2982|TWO_SIDED|95.0|0.34|34.27||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||34.27|0.34|0.2982
72357434|NCT03192176|144229973|SUPERIORITY||Odds Ratio (OR)|12.3||||0.0204|TWO_SIDED|95.0|1.47|102.6||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||102.6|1.47|0.0204
72357435|NCT03192176|144229973|SUPERIORITY||Odds Ratio (OR)|11.1||||0.027|TWO_SIDED|95.0|1.31|93.74||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||93.74|1.31|0.0270
72357436|NCT03192176|144229973|SUPERIORITY||Odds Ratio (OR)|2.22||||0.5224|TWO_SIDED|95.0|0.19|25.68||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||25.68|0.19|0.5224
72357437|NCT03192176|144229973|SUPERIORITY||Odds Ratio (OR)|4.92||||0.1635|TWO_SIDED|95.0|0.52|46.35||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||46.35|0.52|0.1635
72357438|NCT03192176|144229973|SUPERIORITY||Odds Ratio (OR)|10.97||||0.0266|TWO_SIDED|95.0|1.32|91.15||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||91.15|1.32|0.0266
72357439|NCT03192176|144229973|SUPERIORITY||Odds Ratio (OR)|2.69||||0.4299|TWO_SIDED|95.0|0.23|31.21||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||31.21|0.23|0.4299
72357440|NCT03192176|144229973|SUPERIORITY||Odds Ratio (OR)|4.87||||0.1667|TWO_SIDED|95.0|0.52|45.84||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||45.84|0.52|0.1667
72357441|NCT03192176|144229973|SUPERIORITY||Odds Ratio (OR)|8.11||||0.0592|TWO_SIDED|95.0|0.92|71.35||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||71.35|0.92|0.0592
72357442|NCT03192176|144229973|SUPERIORITY||Odds Ratio (OR)|18.28||||0.007|TWO_SIDED|95.0|2.21|151.2||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||151.2|2.21|0.0070
72357443|NCT03192176|144229973|SUPERIORITY||Odds Ratio (OR)|3.79||||0.2594|TWO_SIDED|95.0|0.37|38.32||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||38.32|0.37|0.2594
72357444|NCT03192176|144229973|SUPERIORITY||Odds Ratio (OR)|8.14||||0.0589|TWO_SIDED|95.0|0.92|71.67||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||71.67|0.92|0.0589
72357445|NCT03192176|144229973|SUPERIORITY||Odds Ratio (OR)|10.08||||0.0338|TWO_SIDED|95.0|1.19|85.2||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||85.20|1.19|0.0338
72357446|NCT03192176|144229973|SUPERIORITY||Odds Ratio (OR)|0.76||||0.7756|TWO_SIDED|95.0|0.12|4.88||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||4.88|0.12|0.7756
72357447|NCT03192176|144229973|SUPERIORITY||Odds Ratio (OR)|1.08||||0.9246|TWO_SIDED|95.0|0.2|5.74||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||5.74|0.20|0.9246
72357448|NCT03192176|144229973|SUPERIORITY||Odds Ratio (OR)|5.42||||0.0177|TWO_SIDED|95.0|1.34|21.93||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||21.93|1.34|0.0177
72357449|NCT03192176|144229973|SUPERIORITY||Odds Ratio (OR)|5.38||||0.0178|TWO_SIDED|95.0|1.34|21.65||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||21.65|1.34|0.0178
72357450|NCT03192176|144229973|SUPERIORITY||Odds Ratio (OR)|1.17||||0.8564|TWO_SIDED|95.0|0.22|6.2||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||6.20|0.22|0.8564
72357451|NCT03192176|144229973|SUPERIORITY||Odds Ratio (OR)|2.52||||0.2202|TWO_SIDED|95.0|0.58|11.0||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||11.00|0.58|0.2202
72357452|NCT03192176|144229973|SUPERIORITY||Odds Ratio (OR)|2.37||||0.2498|TWO_SIDED|95.0|0.55|10.25||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||10.25|0.55|0.2498
72357453|NCT03192176|144229973|SUPERIORITY||Odds Ratio (OR)|8.22||||0.0576|TWO_SIDED|95.0|0.93|72.29||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||72.29|0.93|0.0576
72357454|NCT03192176|144229973|SUPERIORITY||Odds Ratio (OR)|3.34||||0.3065|TWO_SIDED|95.0|0.33|33.59||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||33.59|0.33|0.3065
72357455|NCT03192176|144229973|SUPERIORITY||Odds Ratio (OR)|19.9||||0.0056|TWO_SIDED|95.0|2.4|165.1||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||165.1|2.40|0.0056
72357456|NCT03192176|144229973|SUPERIORITY||Odds Ratio (OR)|25.05||||0.0027|TWO_SIDED|95.0|3.05|205.5||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||205.5|3.05|0.0027
72357457|NCT03192176|144229973|SUPERIORITY||Odds Ratio (OR)|3.61||||0.2762|TWO_SIDED|95.0|0.36|36.51||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||36.51|0.36|0.2762
72357458|NCT03192176|144229973|SUPERIORITY||Odds Ratio (OR)|6.93||||0.0851|TWO_SIDED|95.0|0.77|62.69||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||62.69|0.77|0.0851
72357459|NCT03192176|144229973|SUPERIORITY||Odds Ratio (OR)|17.02||||0.0081|TWO_SIDED|95.0|2.09|138.7||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||138.7|2.09|0.0081
72357460|NCT03192176|144229973|SUPERIORITY||Odds Ratio (OR)|6.37||||0.0995|TWO_SIDED|95.0|0.7|57.62||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||57.62|0.70|0.0995
72357461|NCT03192176|144229973|SUPERIORITY||Odds Ratio (OR)|5.76||||0.1184|TWO_SIDED|95.0|0.64|51.8||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||51.80|0.64|0.1184
72357462|NCT03192176|144229973|SUPERIORITY||Odds Ratio (OR)|26.54||||0.0023|TWO_SIDED|95.0|3.23|218.3||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||218.3|3.23|0.0023
72357463|NCT03192176|144229973|SUPERIORITY||Odds Ratio (OR)|19.09||||0.0062|TWO_SIDED|95.0|2.31|157.9||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||157.9|2.31|0.0062
72357464|NCT03192176|144229973|SUPERIORITY||Odds Ratio (OR)|7.49||||0.0695|TWO_SIDED|95.0|0.85|65.87||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||65.87|0.85|0.0695
72357465|NCT03192176|144229973|SUPERIORITY||Odds Ratio (OR)|8.64||||0.052|TWO_SIDED|95.0|0.98|75.98||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||75.98|0.98|0.0520
72357466|NCT03192176|144229973|SUPERIORITY||Odds Ratio (OR)|22.3||||0.0036|TWO_SIDED|95.0|2.75|180.6||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||180.6|2.75|0.0036
72357467|NCT03192176|144229973|SUPERIORITY||Odds Ratio (OR)|4.66||||0.0676|TWO_SIDED|95.0|0.89|24.23||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||24.23|0.89|0.0676
72357468|NCT03192176|144229973|SUPERIORITY||Odds Ratio (OR)|4.14||||0.0903|TWO_SIDED|95.0|0.8|21.38||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||21.38|0.80|0.0903
72357469|NCT03192176|144229973|SUPERIORITY||Odds Ratio (OR)|15.46||||0.0007|TWO_SIDED|95.0|3.18|75.14||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||75.14|3.18|0.0007
72357470|NCT03192176|144229973|SUPERIORITY||Odds Ratio (OR)|10.94||||0.0032|TWO_SIDED|95.0|2.22|53.77||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||53.77|2.22|0.0032
72357471|NCT03192176|144229973|SUPERIORITY||Odds Ratio (OR)|3.04||||0.2031|TWO_SIDED|95.0|0.55|16.85||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||16.85|0.55|0.2031
72357472|NCT03192176|144229973|SUPERIORITY||Odds Ratio (OR)|4.13||||0.0972|TWO_SIDED|95.0|0.77|22.1||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||22.10|0.77|0.0972
72357473|NCT03192176|144229973|SUPERIORITY||Odds Ratio (OR)|11.04||||0.0027|TWO_SIDED|95.0|2.3|53.06||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||53.06|2.30|0.0027
72357474|NCT03192176|144229973|SUPERIORITY||Odds Ratio (OR)|3.06||||0.1306|TWO_SIDED|95.0|0.72|13.02||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||13.02|0.72|0.1306
72357475|NCT03192176|144229973|SUPERIORITY||Odds Ratio (OR)|4.83||||0.0248|TWO_SIDED|95.0|1.22|19.1||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||19.10|1.22|0.0248
72357476|NCT03192176|144229973|SUPERIORITY||Odds Ratio (OR)|7.14||||0.0054|TWO_SIDED|95.0|1.79|28.53||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||28.53|1.79|0.0054
72357477|NCT03192176|144229973|SUPERIORITY||Odds Ratio (OR)|10.01||||0.001|TWO_SIDED|95.0|2.55|39.36||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||39.36|2.55|0.0010
72357478|NCT03192176|144229973|SUPERIORITY||Odds Ratio (OR)|1.21||||0.8271|TWO_SIDED|95.0|0.23|6.45||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||6.45|0.23|0.8271
72357479|NCT03192176|144229973|SUPERIORITY||Odds Ratio (OR)|3.27||||0.1089|TWO_SIDED|95.0|0.77|13.95||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||13.95|0.77|0.1089
72357480|NCT03192176|144229973|SUPERIORITY||Odds Ratio (OR)|5.58||||0.0138|TWO_SIDED|95.0|1.42|21.93||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||21.93|1.42|0.0138
72357481|NCT03192176|144229973|SUPERIORITY||Odds Ratio (OR)|2.4||||0.1987|TWO_SIDED|95.0|0.63|9.15||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||9.15|0.63|0.1987
72357482|NCT03192176|144229973|SUPERIORITY||Odds Ratio (OR)|1.8||||0.3984|TWO_SIDED|95.0|0.46|7.02||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||7.02|0.46|0.3984
72357483|NCT03192176|144229973|SUPERIORITY||Odds Ratio (OR)|3.92||||0.0402|TWO_SIDED|95.0|1.06|14.45||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||14.45|1.06|0.0402
72357484|NCT03192176|144229973|SUPERIORITY||Odds Ratio (OR)|8.05||||0.001|TWO_SIDED|95.0|2.32|27.95||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||27.95|2.32|0.0010
72357485|NCT03192176|144229973|SUPERIORITY||Odds Ratio (OR)|0.84||||0.8287|TWO_SIDED|95.0|0.17|4.08||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||4.08|0.17|0.8287
72357486|NCT03192176|144229973|SUPERIORITY||Odds Ratio (OR)|2.93||||0.1083|TWO_SIDED|95.0|0.79|10.92||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||10.92|0.79|0.1083
72357487|NCT03192176|144229973|SUPERIORITY||Odds Ratio (OR)|6.03||||0.0043|TWO_SIDED|95.0|1.76|20.66||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||20.66|1.76|0.0043
72357488|NCT03192176|144229973|SUPERIORITY||Odds Ratio (OR)|3.23||||0.1126|TWO_SIDED|95.0|0.76|13.79||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||13.79|0.76|0.1126
72357489|NCT03192176|144229973|SUPERIORITY||Odds Ratio (OR)|2.9||||0.1479|TWO_SIDED|95.0|0.69|12.3||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||12.30|0.69|0.1479
72357490|NCT03192176|144229973|SUPERIORITY||Odds Ratio (OR)|10.49||||0.001|TWO_SIDED|95.0|2.59|42.46||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||42.46|2.59|0.0010
72357491|NCT03192176|144229973|SUPERIORITY||Odds Ratio (OR)|13.01||||0.0002|TWO_SIDED|95.0|3.31|51.14||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||51.14|3.31|0.0002
72357492|NCT03192176|144229973|SUPERIORITY||Odds Ratio (OR)|2.91||||0.1483|TWO_SIDED|95.0|0.68|12.41||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||12.41|0.68|0.1483
72357493|NCT03192176|144229973|SUPERIORITY||Odds Ratio (OR)|4.03||||0.0557|TWO_SIDED|95.0|0.97|16.84||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||16.84|0.97|0.0557
72357494|NCT03192176|144229973|SUPERIORITY||Odds Ratio (OR)|6.47||||0.0072|TWO_SIDED|95.0|1.66|25.28||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||25.28|1.66|0.0072
72357495|NCT03192176|144229973|SUPERIORITY||Odds Ratio (OR)|1.02||||0.9715|TWO_SIDED|95.0|0.32|3.24||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||3.24|0.32|0.9715
72357496|NCT03192176|144229973|SUPERIORITY||Odds Ratio (OR)|1.49||||0.472|TWO_SIDED|95.0|0.5|4.39||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||4.39|0.50|0.4720
72357497|NCT03192176|144229973|SUPERIORITY||Odds Ratio (OR)|2.35||||0.1262|TWO_SIDED|95.0|0.79|7.05||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||7.05|0.79|0.1262
72357498|NCT03192176|144229973|SUPERIORITY||Odds Ratio (OR)|3.07||||0.0396|TWO_SIDED|95.0|1.05|8.92||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||8.92|1.05|0.0396
72357499|NCT03192176|144229973|SUPERIORITY||Odds Ratio (OR)|0.66||||0.5137|TWO_SIDED|95.0|0.19|2.29||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||2.29|0.19|0.5137
72357500|NCT03192176|144229973|SUPERIORITY||Odds Ratio (OR)|2.25||||0.137|TWO_SIDED|95.0|0.77|6.58||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||6.58|0.77|0.1370
72357501|NCT03192176|144229973|SUPERIORITY||Odds Ratio (OR)|1.39||||0.5526|TWO_SIDED|95.0|0.47|4.07||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||4.07|0.47|0.5526
72357502|NCT03192176|144229974|SUPERIORITY||Odds Ratio (OR)|5.75||||0.0012|TWO_SIDED|95.0|1.99|16.62||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||16.62|1.99|0.0012
72357503|NCT03192176|144229974|SUPERIORITY||Odds Ratio (OR)|8.86|||<|0.0001|TWO_SIDED|95.0|3.06|25.68||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||25.68|3.06|<0.0001
72357504|NCT03192176|144229974|SUPERIORITY||Odds Ratio (OR)|11.55|||<|0.0001|TWO_SIDED|95.0|3.94|33.85||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||33.85|3.94|<0.0001
72357505|NCT03192176|144229974|SUPERIORITY||Odds Ratio (OR)|13.55|||<|0.0001|TWO_SIDED|95.0|4.55|40.38||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||40.38|4.55|<0.0001
72357506|NCT03192176|144229974|SUPERIORITY||Odds Ratio (OR)|2.9||||0.0555|TWO_SIDED|95.0|0.98|8.61||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||8.61|0.98|0.0555
72357507|NCT03192176|144229974|SUPERIORITY||Odds Ratio (OR)|7.98||||0.0001|TWO_SIDED|95.0|2.75|23.18||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||23.18|2.75|0.0001
72357508|NCT03192176|144229974|SUPERIORITY||Odds Ratio (OR)|8.07||||0.0001|TWO_SIDED|95.0|2.81|23.19||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||23.19|2.81|0.0001
72357509|NCT03192176|144229974|SUPERIORITY||Odds Ratio (OR)|4.55||||0.0012|TWO_SIDED|95.0|1.82|11.39||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||11.39|1.82|0.0012
72357510|NCT03192176|144229974|SUPERIORITY||Odds Ratio (OR)|5.25||||0.0005|TWO_SIDED|95.0|2.06|13.43||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||13.43|2.06|0.0005
72357511|NCT03192176|144229974|SUPERIORITY||Odds Ratio (OR)|5.62||||0.0003|TWO_SIDED|95.0|2.2|14.39||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||14.39|2.20|0.0003
72357512|NCT03192176|144229974|SUPERIORITY||Odds Ratio (OR)|8.42|||<|0.0001|TWO_SIDED|95.0|2.99|23.74||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||23.74|2.99|<0.0001
72357513|NCT03192176|144229974|SUPERIORITY||Odds Ratio (OR)|2.74||||0.0277|TWO_SIDED|95.0|1.12|6.7||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||6.70|1.12|0.0277
72357514|NCT03192176|144229974|SUPERIORITY||Odds Ratio (OR)|4.15||||0.0022|TWO_SIDED|95.0|1.66|10.32||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||10.32|1.66|0.0022
72357515|NCT03192176|144229974|SUPERIORITY||Odds Ratio (OR)|3.06||||0.0314|TWO_SIDED|95.0|1.26|7.41||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||7.41|1.26|0.0314
72357516|NCT03192176|144229974|SUPERIORITY||Odds Ratio (OR)|3.92||||0.0041|TWO_SIDED|95.0|1.54|9.97||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||9.97|1.54|0.0041
72357517|NCT03192176|144229974|SUPERIORITY||Odds Ratio (OR)|4.19||||0.0028|TWO_SIDED|95.0|1.64|10.74||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||10.74|1.64|0.0028
72357518|NCT03192176|144229974|SUPERIORITY||Odds Ratio (OR)|4.96||||0.0011|TWO_SIDED|95.0|1.9|12.98||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||12.98|1.90|0.0011
72357519|NCT03192176|144229974|SUPERIORITY||Odds Ratio (OR)|8.79||||0.0001|TWO_SIDED|95.0|2.86|26.99||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||26.99|2.86|0.0001
72357520|NCT03192176|144229974|SUPERIORITY||Odds Ratio (OR)|4.09||||0.0036|TWO_SIDED|95.0|1.59|10.57||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||10.57|1.59|0.0036
72357521|NCT03192176|144229974|SUPERIORITY||Odds Ratio (OR)|4.52||||0.0018|TWO_SIDED|95.0|1.75|11.67||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||11.67|1.75|0.0018
72357522|NCT03192176|144229974|SUPERIORITY||Odds Ratio (OR)|2.76||||0.0243|TWO_SIDED|95.0|1.14|6.68||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||6.68|1.14|0.0243
72357523|NCT03192176|144229974|SUPERIORITY||Odds Ratio (OR)|2.33||||0.077|TWO_SIDED|95.0|0.91|5.96||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||5.96|0.91|0.0770
72357524|NCT03192176|144229974|SUPERIORITY||Odds Ratio (OR)|2.61||||0.0451|TWO_SIDED|95.0|1.02|6.69||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||6.69|1.02|0.0451
72357525|NCT03192176|144229974|SUPERIORITY||Odds Ratio (OR)|3.36||||0.0165|TWO_SIDED|95.0|1.25|9.04||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||9.04|1.25|0.0165
72357526|NCT03192176|144229974|SUPERIORITY||Odds Ratio (OR)|5.28||||0.0037|TWO_SIDED|95.0|1.72|16.23||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||16.23|1.72|0.0037
72357527|NCT03192176|144229974|SUPERIORITY||Odds Ratio (OR)|2.29||||0.0812|TWO_SIDED|95.0|0.9|5.82||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||5.82|0.90|0.0812
72357528|NCT03192176|144229974|SUPERIORITY||Odds Ratio (OR)|2.46||||0.0577|TWO_SIDED|95.0|0.97|6.22||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||6.22|0.97|0.0577
72357529|NCT03192176|144229974|SUPERIORITY||Odds Ratio (OR)|2.33||||0.0706|TWO_SIDED|95.0|0.93|5.85||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||5.85|0.93|0.0706
72357530|NCT03192176|144229974|SUPERIORITY||Odds Ratio (OR)|2.7||||0.0404|TWO_SIDED|95.0|1.04|7.0||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||7.00|1.04|0.0404
72357531|NCT03192176|144229974|SUPERIORITY||Odds Ratio (OR)|4.3||||0.0054|TWO_SIDED|95.0|1.54|11.99||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||11.99|1.54|0.0054
72357532|NCT03192176|144229974|SUPERIORITY||Odds Ratio (OR)|3.37||||0.0186|TWO_SIDED|95.0|1.22|9.27||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||9.27|1.22|0.0186
72357533|NCT03192176|144229974|SUPERIORITY||Odds Ratio (OR)|6.58||||0.0023|TWO_SIDED|95.0|1.96|22.14||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||22.14|1.96|0.0023
72357534|NCT03192176|144229974|SUPERIORITY||Odds Ratio (OR)|3.63||||0.0118|TWO_SIDED|95.0|1.33|9.93||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||9.93|1.33|0.0118
72357535|NCT03192176|144229974|SUPERIORITY||Odds Ratio (OR)|5.57||||0.002|TWO_SIDED|95.0|1.88|16.53||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||16.53|1.88|0.0020
72357536|NCT03192176|144229974|SUPERIORITY||Odds Ratio (OR)|2.71||||0.043|TWO_SIDED|95.0|1.03|7.14||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||7.14|1.03|0.0430
72357537|NCT03192176|144229974|SUPERIORITY||Odds Ratio (OR)|1.81||||0.2197|TWO_SIDED|95.0|0.7|4.66||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||4.66|0.70|0.2197
72357538|NCT03192176|144229974|SUPERIORITY||Odds Ratio (OR)|2.08||||0.1341|TWO_SIDED|95.0|0.8|5.42||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||5.42|0.80|0.1341
72357539|NCT03192176|144229974|SUPERIORITY||Odds Ratio (OR)|3.69||||0.0196|TWO_SIDED|95.0|1.23|11.05||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||11.05|1.23|0.0196
72357540|NCT03192176|144229974|SUPERIORITY||Odds Ratio (OR)|4.79||||0.0121|TWO_SIDED|95.0|1.41|16.26||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||16.26|1.41|0.0121
72357541|NCT03192176|144229974|SUPERIORITY||Odds Ratio (OR)|2.06||||0.1511|TWO_SIDED|95.0|0.77|5.56||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||5.56|0.77|0.1511
72357542|NCT03192176|144229974|SUPERIORITY||Odds Ratio (OR)|4.94||||0.0068|TWO_SIDED|95.0|1.55|15.68||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||15.68|1.55|0.0068
72357543|NCT03192176|144229974|SUPERIORITY||Odds Ratio (OR)|2.49||||0.0741|TWO_SIDED|95.0|0.91|6.79||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||6.79|0.91|0.0741
72357544|NCT03192176|144229974|SUPERIORITY||Odds Ratio (OR)|1.7||||0.2772|TWO_SIDED|95.0|0.65|4.43||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||4.43|0.65|0.2772
72357545|NCT03192176|144229974|SUPERIORITY||Odds Ratio (OR)|2.55||||0.0705|TWO_SIDED|95.0|0.92|7.02||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||7.02|0.92|0.0705
72357546|NCT03192176|144229974|SUPERIORITY||Odds Ratio (OR)|3.88||||0.022|TWO_SIDED|95.0|1.22|12.39||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||12.39|1.22|0.0220
72357547|NCT03192176|144229974|SUPERIORITY||Odds Ratio (OR)|4.33||||0.0196|TWO_SIDED|95.0|1.27|14.82||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||14.82|1.27|0.0196
72357548|NCT03192176|144229974|SUPERIORITY||Odds Ratio (OR)|3.09||||0.0433|TWO_SIDED|95.0|1.03|9.24||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||9.24|1.03|0.0433
72357549|NCT03192176|144229974|SUPERIORITY||Odds Ratio (OR)|3.15||||0.0355|TWO_SIDED|95.0|1.08|9.2||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||9.20|1.08|0.0355
72357550|NCT03192176|144229974|SUPERIORITY||Odds Ratio (OR)|1.63||||0.3238|TWO_SIDED|95.0|0.62|4.28||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||4.28|0.62|0.3238
72357551|NCT03192176|144229974|SUPERIORITY||Odds Ratio (OR)|1.68||||0.3208|TWO_SIDED|95.0|0.6|4.68||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||4.68|0.60|0.3208
72357552|NCT03192176|144229974|SUPERIORITY||Odds Ratio (OR)|1.9||||0.2281|TWO_SIDED|95.0|0.67|5.4||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||5.40|0.67|0.2281
72357553|NCT03192176|144229974|SUPERIORITY||Odds Ratio (OR)|3.18||||0.0566|TWO_SIDED|95.0|0.97|10.46||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||10.46|0.97|0.0566
72357554|NCT03192176|144229974|SUPERIORITY||Odds Ratio (OR)|2.39||||0.1491|TWO_SIDED|95.0|0.73|7.78||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||7.78|0.73|0.1491
72357555|NCT03192176|144229974|SUPERIORITY||Odds Ratio (OR)|2.32||||0.1477|TWO_SIDED|95.0|0.74|7.23||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||7.23|0.74|0.1477
72357556|NCT03192176|144229974|SUPERIORITY||Odds Ratio (OR)|3.24||||0.0532|TWO_SIDED|95.0|0.98|10.64||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||10.64|0.98|0.0532
72357557|NCT03192176|144229974|SUPERIORITY||Odds Ratio (OR)|2.22||||0.1616|TWO_SIDED|95.0|0.73|6.76||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||6.76|0.73|0.1616
72357558|NCT03192176|144229974|SUPERIORITY||Odds Ratio (OR)|1.5||||0.432|TWO_SIDED|95.0|0.55|4.11||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||4.11|0.55|0.4320
72357559|NCT03192176|144229974|SUPERIORITY||Odds Ratio (OR)|1.9||||0.2231|TWO_SIDED|95.0|0.68|5.35||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||5.35|0.68|0.2231
72357560|NCT03192176|144229974|SUPERIORITY||Odds Ratio (OR)|3.88||||0.0347|TWO_SIDED|95.0|1.1|13.64||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||13.64|1.10|0.0347
72357561|NCT03192176|144229974|SUPERIORITY||Odds Ratio (OR)|4.59||||0.0291|TWO_SIDED|95.0|1.17|18.07||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||18.07|1.17|0.0291
72357562|NCT03192176|144229974|SUPERIORITY||Odds Ratio (OR)|1.82||||0.2805|TWO_SIDED|95.0|0.61|5.38||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||5.38|0.61|0.2805
72357563|NCT03192176|144229974|SUPERIORITY||Odds Ratio (OR)|3.1||||0.0602|TWO_SIDED|95.0|0.95|10.11||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||10.11|0.95|0.0602
72357564|NCT03192176|144229974|SUPERIORITY||Odds Ratio (OR)|1.41||||0.5087|TWO_SIDED|95.0|0.51|3.88||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||3.88|0.51|0.5087
72357565|NCT03192176|144229974|SUPERIORITY||Odds Ratio (OR)|2.26||||0.1224|TWO_SIDED|95.0|0.8|6.38||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||6.38|0.80|0.1224
72357566|NCT03192176|144229974|SUPERIORITY||Odds Ratio (OR)|1.85||||0.228|TWO_SIDED|95.0|0.68|5.02||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||5.02|0.68|0.2280
72357567|NCT03192176|144229974|SUPERIORITY||Odds Ratio (OR)|2.07||||0.1835|TWO_SIDED|95.0|0.71|6.02||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||6.02|0.71|0.1835
72357568|NCT03192176|144229974|SUPERIORITY||Odds Ratio (OR)|5.85||||0.0107|TWO_SIDED|95.0|1.51|22.69||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||22.69|1.51|0.0107
72357569|NCT03192176|144229974|SUPERIORITY||Odds Ratio (OR)|2.94||||0.0576|TWO_SIDED|95.0|0.97|8.96||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||8.96|0.97|0.0576
72357570|NCT03192176|144229974|SUPERIORITY||Odds Ratio (OR)|9.68||||0.0047|TWO_SIDED|95.0|2.0|46.77||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||46.77|2.00|0.0047
72357571|NCT03192176|144229974|SUPERIORITY||Odds Ratio (OR)|2.89||||0.0569|TWO_SIDED|95.0|0.97|8.64||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||8.64|0.97|0.0569
72357572|NCT03192176|144229974|SUPERIORITY||Odds Ratio (OR)|2.35||||0.1078|TWO_SIDED|95.0|0.83|6.68||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||6.68|0.83|0.1078
72357573|NCT03192176|144229974|SUPERIORITY||Odds Ratio (OR)|2.6||||0.0772|TWO_SIDED|95.0|0.9|7.47||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||7.47|0.90|0.0772
72357574|NCT03192176|144229974|SUPERIORITY||Odds Ratio (OR)|2.36||||0.1311|TWO_SIDED|95.0|0.77|7.22||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||7.22|0.77|0.1311
72357575|NCT03192176|144229974|SUPERIORITY||Odds Ratio (OR)|5.64||||0.01255|TWO_SIDED|95.0|1.45|21.96||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||21.96|1.45|0.01255
72357576|NCT03192176|144229974|SUPERIORITY||Odds Ratio (OR)|4.97||||0.0128|TWO_SIDED|95.0|1.41|17.54||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||17.54|1.41|0.0128
72357577|NCT03192176|144229974|SUPERIORITY||Odds Ratio (OR)|6.32||||0.0079|TWO_SIDED|95.0|1.62|24.63||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||24.63|1.62|0.0079
72357578|NCT03192176|144229974|SUPERIORITY||Odds Ratio (OR)|2.9||||0.0572|TWO_SIDED|95.0|0.97|8.67||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||8.67|0.97|0.0572
72357579|NCT03192176|144229974|SUPERIORITY||Odds Ratio (OR)|3.33||||0.0284|TWO_SIDED|95.0|1.14|9.79||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||9.79|1.14|0.0284
72357580|NCT03192176|144229974|SUPERIORITY||Odds Ratio (OR)|2.58||||0.0705|TWO_SIDED|95.0|0.92|7.22||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||7.22|0.92|0.0705
72357581|NCT03192176|144229974|SUPERIORITY||Odds Ratio (OR)|4.81||||0.0136|TWO_SIDED|95.0|1.38|16.77||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||16.77|1.38|0.0136
72357582|NCT03192176|144229974|SUPERIORITY||Odds Ratio (OR)|9.96||||0.0043|TWO_SIDED|95.0|2.06|48.29||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||48.29|2.06|0.0043
72357583|NCT03192176|144229974|SUPERIORITY||Odds Ratio (OR)|2.66||||0.076|TWO_SIDED|95.0|0.9|7.83||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||7.83|0.90|0.0760
72357584|NCT03192176|144229974|SUPERIORITY||Odds Ratio (OR)|5.75||||0.0059|TWO_SIDED|95.0|1.65|20.0||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||20.00|1.65|0.0059
72357585|NCT03192176|144229974|SUPERIORITY||Odds Ratio (OR)|4.22||||0.0143|TWO_SIDED|95.0|1.33|13.35||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||13.35|1.33|0.0143
72357586|NCT03192176|144229974|SUPERIORITY||Odds Ratio (OR)|1.82||||0.2779|TWO_SIDED|95.0|0.62|5.35||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||5.35|0.62|0.2779
72357587|NCT03192176|144229974|SUPERIORITY||Odds Ratio (OR)|1.18||||0.7559|TWO_SIDED|95.0|0.41|3.41||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||3.41|0.41|0.7559
72357588|NCT03192176|144229974|SUPERIORITY||Odds Ratio (OR)|1.07||||0.905|TWO_SIDED|95.0|0.35|3.23||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||3.23|0.35|0.9050
72357589|NCT03192176|144229974|SUPERIORITY||Odds Ratio (OR)|2.05||||0.2163|TWO_SIDED|95.0|0.66|6.38||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||6.38|0.66|0.2163
72357590|NCT03192176|144229974|SUPERIORITY||Odds Ratio (OR)|2.24||||0.1713|TWO_SIDED|95.0|0.7|7.14||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||7.14|0.70|0.1713
72357591|NCT03192176|144229974|SUPERIORITY||Odds Ratio (OR)|1.63||||0.3981|TWO_SIDED|95.0|0.52|5.09||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||5.09|0.52|0.3981
72357592|NCT03192176|144229974|SUPERIORITY||Odds Ratio (OR)|1.02||||0.9692|TWO_SIDED|95.0|0.35|2.96||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||2.96|0.35|0.9692
72357593|NCT03192176|144229974|SUPERIORITY||Odds Ratio (OR)|1.77||||0.2978|TWO_SIDED|95.0|0.6|5.22||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||5.22|0.60|0.2978
72357594|NCT03192176|144229974|SUPERIORITY||Odds Ratio (OR)|1.11||||0.8525|TWO_SIDED|95.0|0.38|3.18||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||3.18|0.38|0.8525
72357595|NCT03192176|144229974|SUPERIORITY||Odds Ratio (OR)|0.67||||0.5028|TWO_SIDED|95.0|0.21|2.13||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||2.13|0.21|0.5028
72357596|NCT03192176|144229974|SUPERIORITY||Odds Ratio (OR)|1.53||||0.4594|TWO_SIDED|95.0|0.5|4.73||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||4.73|0.50|0.4594
72357597|NCT03192176|144229974|SUPERIORITY||Odds Ratio (OR)|2.56||||0.1124|TWO_SIDED|95.0|0.8|8.17||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||8.17|0.80|0.1124
72357598|NCT03192176|144229974|SUPERIORITY||Odds Ratio (OR)|1.75||||0.3415|TWO_SIDED|95.0|0.55|5.58||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||5.58|0.55|0.3415
72357599|NCT03192176|144229974|SUPERIORITY||Odds Ratio (OR)|1.65||||0.3635|TWO_SIDED|95.0|0.56|4.83||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||4.83|0.56|0.3635
72357600|NCT03192176|144229974|SUPERIORITY||Odds Ratio (OR)|0.73||||0.5716|TWO_SIDED|95.0|0.24|2.2||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||2.20|0.24|0.5716
72357601|NCT03192176|144229974|SUPERIORITY||Odds Ratio (OR)|0.69||||0.5028|TWO_SIDED|95.0|0.23|2.05||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||2.05|0.23|0.5028
72357602|NCT03192176|144229974|SUPERIORITY||Odds Ratio (OR)|0.6||||0.3982|TWO_SIDED|95.0|0.18|1.98||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||1.98|0.18|0.3982
72357603|NCT03192176|144229974|SUPERIORITY||Odds Ratio (OR)|0.93||||0.93|TWO_SIDED|95.0|0.3|2.87||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||2.87|0.30|0.93
72357604|NCT03192176|144229974|SUPERIORITY||Odds Ratio (OR)|2.12||||0.2364|TWO_SIDED|95.0|0.61|7.32||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||7.32|0.61|0.2364
72357605|NCT03192176|144229974|SUPERIORITY||Odds Ratio (OR)|1.25||||0.7095|TWO_SIDED|95.0|0.39|4.04||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||4.04|0.39|0.7095
72357606|NCT03192176|144229974|SUPERIORITY||Odds Ratio (OR)|0.75||||0.6011|TWO_SIDED|95.0|0.26|2.2||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||2.20|0.26|0.6011
72357607|NCT03192176|144229975|SUPERIORITY||Odds Ratio (OR)|6.78||||0.0181|TWO_SIDED|95.0|1.39|33.1||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||33.10|1.39|0.0181
72357608|NCT03192176|144229975|SUPERIORITY||Odds Ratio (OR)|9.97||||0.0039|TWO_SIDED|95.0|2.1|47.48||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||47.48|2.10|0.0039
72357609|NCT03192176|144229975|SUPERIORITY||Odds Ratio (OR)|21.2||||0.0001|TWO_SIDED|95.0|4.51|99.65||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||99.65|4.51|0.0001
72357610|NCT03192176|144229975|SUPERIORITY||Odds Ratio (OR)|23.97|||<|0.0001|TWO_SIDED|95.0|5.09|112.9||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||112.9|5.09|<0.0001
72357611|NCT03192176|144229975|SUPERIORITY||Odds Ratio (OR)|3.17||||0.1766|TWO_SIDED|95.0|0.59|16.87||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||16.87|0.59|0.1766
72357612|NCT03192176|144229975|SUPERIORITY||Odds Ratio (OR)|7.68||||0.0116|TWO_SIDED|95.0|1.58|37.43||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||37.43|1.58|0.0116
72357613|NCT03192176|144229975|SUPERIORITY||Odds Ratio (OR)|12.74||||0.0013|TWO_SIDED|95.0|2.71|59.81||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||59.81|2.71|0.0013
72357614|NCT03192176|144229975|SUPERIORITY||Odds Ratio (OR)|2.82||||0.0359|TWO_SIDED|95.0|1.07|7.43||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||7.43|1.07|0.0359
72357615|NCT03192176|144229975|SUPERIORITY||Odds Ratio (OR)|5.8||||0.0004|TWO_SIDED|95.0|2.2|15.33||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||15.33|2.20|0.0004
72357616|NCT03192176|144229975|SUPERIORITY||Odds Ratio (OR)|7.13|||<|0.0001|TWO_SIDED|95.0|2.68|18.98||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||18.98|2.68|<0.0001
72357617|NCT03192176|144229975|SUPERIORITY||Odds Ratio (OR)|6.84||||0.0001|TWO_SIDED|95.0|2.53|18.46||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||18.46|2.53|0.0001
72357618|NCT03192176|144229975|SUPERIORITY||Odds Ratio (OR)|2.04||||0.154|TWO_SIDED|95.0|0.76|5.47||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||5.47|0.76|0.1540
72357619|NCT03192176|144229975|SUPERIORITY||Odds Ratio (OR)|3.84||||0.0065|TWO_SIDED|95.0|1.46|10.12||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||10.12|1.46|0.0065
72357620|NCT03192176|144229975|SUPERIORITY||Odds Ratio (OR)|3.9||||0.0052|TWO_SIDED|95.0|1.5|10.14||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||10.14|1.50|0.0052
72357621|NCT03192176|144229975|SUPERIORITY||Odds Ratio (OR)|3.68||||0.0064|TWO_SIDED|95.0|1.44|9.39||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||9.39|1.44|0.0064
72429310|NCT01154036|144369653|SUPERIORITY_OR_OTHER_LEGACY||Difference in M-estimates|-9.5|||<|0.001|TWO_SIDED|95.0|-13.6|-5.5||The secondary hypotheses were tested at an adaptive alpha level depending on the hypotheses testing result of the primary hypotheses.|Multiple Imputation Robust Regression|M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values||||-5.5|-13.6|<0.001
72357622|NCT03192176|144229975|SUPERIORITY||Odds Ratio (OR)|5.86||||0.0003|TWO_SIDED|95.0|2.26|15.21||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||15.21|2.26|0.0003
72357623|NCT03192176|144229975|SUPERIORITY||Odds Ratio (OR)|6.42||||0.0001|TWO_SIDED|95.0|2.47|16.69||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||16.69|2.47|0.0001
72357624|NCT03192176|144229975|SUPERIORITY||Odds Ratio (OR)|8.21|||<|0.0001|TWO_SIDED|95.0|3.01|22.42||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||22.42|3.01|<0.0001
72357625|NCT03192176|144229975|SUPERIORITY||Odds Ratio (OR)|3.12||||0.0171|TWO_SIDED|95.0|1.22|7.97||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||7.97|1.22|0.0171
72357626|NCT03192176|144229975|SUPERIORITY||Odds Ratio (OR)|4.38||||0.002|TWO_SIDED|95.0|1.71|11.18||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||11.18|1.71|0.0020
72357627|NCT03192176|144229975|SUPERIORITY||Odds Ratio (OR)|3.97||||0.0034|TWO_SIDED|95.0|1.58|9.99||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||9.99|1.58|0.0034
72357628|NCT03192176|144229975|SUPERIORITY||Odds Ratio (OR)|2.63||||0.0399|TWO_SIDED|95.0|1.05|6.59||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||6.59|1.05|0.0399
72357629|NCT03192176|144229975|SUPERIORITY||Odds Ratio (OR)|5.76||||0.0003|TWO_SIDED|95.0|2.23|14.84||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||14.84|2.23|0.0003
72357630|NCT03192176|144229975|SUPERIORITY||Odds Ratio (OR)|4.05||||0.0031|TWO_SIDED|95.0|1.6|10.23||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||10.23|1.60|0.0031
72357631|NCT03192176|144229975|SUPERIORITY||Odds Ratio (OR)|9.82|||<|0.0001|TWO_SIDED|95.0|3.41|28.28||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||28.28|3.41|<0.0001
72357632|NCT03192176|144229975|SUPERIORITY||Odds Ratio (OR)|3.96||||0.0036|TWO_SIDED|95.0|1.57|10.01||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||10.01|1.57|0.0036
72357633|NCT03192176|144229975|SUPERIORITY||Odds Ratio (OR)|4.79||||0.0009|TWO_SIDED|95.0|1.89|12.11||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||12.11|1.89|0.0009
72357634|NCT03192176|144229975|SUPERIORITY||Odds Ratio (OR)|3.33||||0.0091|TWO_SIDED|95.0|1.35|8.21||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||8.21|1.35|0.0091
72357635|NCT03192176|144229975|SUPERIORITY||Odds Ratio (OR)|1.78||||0.2043|TWO_SIDED|95.0|0.73|4.34||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||4.34|0.73|0.2043
72357636|NCT03192176|144229975|SUPERIORITY||Odds Ratio (OR)|4.7||||0.0012|TWO_SIDED|95.0|1.84|12.01||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||12.01|1.84|0.0012
72357637|NCT03192176|144229975|SUPERIORITY||Odds Ratio (OR)|3.77||||0.0058|TWO_SIDED|95.0|1.47|9.7||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||9.70|1.47|0.0058
72357638|NCT03192176|144229975|SUPERIORITY||Odds Ratio (OR)|8.07||||0.0002|TWO_SIDED|95.0|2.73|23.83||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||23.83|2.73|0.0002
72357639|NCT03192176|144229975|SUPERIORITY||Odds Ratio (OR)|2.88||||0.0221|TWO_SIDED|95.0|1.16|7.12||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||7.12|1.16|0.0221
72357640|NCT03192176|144229975|SUPERIORITY||Odds Ratio (OR)|4.0||||0.0034|TWO_SIDED|95.0|1.58|10.13||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||10.13|1.58|0.0034
72357641|NCT03192176|144229975|SUPERIORITY||Odds Ratio (OR)|3.22||||0.0123|TWO_SIDED|95.0|1.29|8.04||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||8.04|1.29|0.0123
72357642|NCT03192176|144229975|SUPERIORITY||Odds Ratio (OR)|1.56||||0.3291|TWO_SIDED|95.0|0.64|3.78||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||3.78|0.64|0.3291
72357643|NCT03192176|144229975|SUPERIORITY||Odds Ratio (OR)|3.27||||0.0118|TWO_SIDED|95.0|1.3|8.21||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||8.21|1.30|0.0118
72357644|NCT03192176|144229975|SUPERIORITY||Odds Ratio (OR)|3.93||||0.0058|TWO_SIDED|95.0|1.49|10.4||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||10.40|1.49|0.0058
72357645|NCT03192176|144229975|SUPERIORITY||Odds Ratio (OR)|5.98||||0.0012|TWO_SIDED|95.0|2.03|17.65||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||17.65|2.03|0.0012
72357646|NCT03192176|144229975|SUPERIORITY||Odds Ratio (OR)|2.13||||0.1043|TWO_SIDED|95.0|0.85|5.32||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||5.32|0.85|0.1043
72357647|NCT03192176|144229975|SUPERIORITY||Odds Ratio (OR)|5.01||||0.0015|TWO_SIDED|95.0|1.85|13.54||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||13.54|1.85|0.0015
72357648|NCT03192176|144229975|SUPERIORITY||Odds Ratio (OR)|2.33||||0.0658|TWO_SIDED|95.0|0.95|5.73||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||5.73|0.95|0.0658
72357649|NCT03192176|144229975|SUPERIORITY||Odds Ratio (OR)|2.02||||0.1253|TWO_SIDED|95.0|0.82|4.98||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||4.98|0.82|0.1253
72357650|NCT03192176|144229975|SUPERIORITY||Odds Ratio (OR)|5.01||||0.0013|TWO_SIDED|95.0|1.88|13.34||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||13.34|1.88|0.0013
72357651|NCT03192176|144229975|SUPERIORITY||Odds Ratio (OR)|3.66||||0.0096|TWO_SIDED|95.0|1.37|9.75||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||9.75|1.37|0.0096
72357652|NCT03192176|144229975|SUPERIORITY||Odds Ratio (OR)|6.06||||0.0012|TWO_SIDED|95.0|2.04|17.96||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||17.96|2.04|0.0012
72357653|NCT03192176|144229975|SUPERIORITY||Odds Ratio (OR)|2.75||||0.0344|TWO_SIDED|95.0|1.08|7.02||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||7.02|1.08|0.0344
72357654|NCT03192176|144229975|SUPERIORITY||Odds Ratio (OR)|4.07||||0.0045|TWO_SIDED|95.0|1.55|10.72||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||10.72|1.55|0.0045
72357655|NCT03192176|144229975|SUPERIORITY||Odds Ratio (OR)|2.24||||0.081|TWO_SIDED|95.0|0.91|5.55||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||5.55|0.91|0.0810
72357656|NCT03192176|144229975|SUPERIORITY||Odds Ratio (OR)|2.29||||0.0761|TWO_SIDED|95.0|0.92|5.7||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||5.70|0.92|0.0761
72357657|NCT03192176|144229975|SUPERIORITY||Odds Ratio (OR)|3.66||||0.0078|TWO_SIDED|95.0|1.41|9.51||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||9.51|1.41|0.0078
72429311|NCT01154036|144369654|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.51|||<|0.001|TWO_SIDED|95.0|1.62|3.89|||Logistic Regression Model|Logistic regression model included terms for treatment and baseline LDL-C (where baseline LDL-C was fitted as 3 categories based on tertiles)||||3.89|1.62|<0.001
72357658|NCT03192176|144229975|SUPERIORITY||Odds Ratio (OR)|2.99||||0.0253|TWO_SIDED|95.0|1.15|7.82||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||7.82|1.15|0.0253
72357659|NCT03192176|144229975|SUPERIORITY||Odds Ratio (OR)|6.23||||0.0017|TWO_SIDED|95.0|1.99|19.55||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||19.55|1.99|0.0017
72357660|NCT03192176|144229975|SUPERIORITY||Odds Ratio (OR)|1.55||||0.3512|TWO_SIDED|95.0|0.62|3.87||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||3.87|0.62|0.3512
72357661|NCT03192176|144229975|SUPERIORITY||Odds Ratio (OR)|2.77||||0.0352|TWO_SIDED|95.0|1.07|7.13||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||7.13|1.07|0.0352
72357662|NCT03192176|144229975|SUPERIORITY||Odds Ratio (OR)|2.36||||0.0704|TWO_SIDED|95.0|0.93|5.97||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||5.97|0.93|0.0704
72357663|NCT03192176|144229975|SUPERIORITY||Odds Ratio (OR)|1.94||||0.1651|TWO_SIDED|95.0|0.76|4.93||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||4.93|0.76|0.1651
72357664|NCT03192176|144229975|SUPERIORITY||Odds Ratio (OR)|2.21||||0.0964|TWO_SIDED|95.0|0.87|5.62||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||5.62|0.87|0.0964
72357665|NCT03192176|144229975|SUPERIORITY||Odds Ratio (OR)|3.12||||0.0276|TWO_SIDED|95.0|1.13|8.59||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||8.59|1.13|0.0276
72357666|NCT03192176|144229975|SUPERIORITY||Odds Ratio (OR)|4.99||||0.006|TWO_SIDED|95.0|1.58|15.7||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||15.70|1.58|0.0060
72357667|NCT03192176|144229975|SUPERIORITY||Odds Ratio (OR)|2.03||||0.1556|TWO_SIDED|95.0|0.76|5.39||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||5.39|0.76|0.1556
72357668|NCT03192176|144229975|SUPERIORITY||Odds Ratio (OR)|3.33||||0.0202|TWO_SIDED|95.0|1.21|9.18||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||9.18|1.21|0.0202
72357669|NCT03192176|144229975|SUPERIORITY||Odds Ratio (OR)|1.83||||0.2063|TWO_SIDED|95.0|0.72|4.67||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||4.67|0.72|0.2063
72357670|NCT03192176|144229975|SUPERIORITY||Odds Ratio (OR)|2.7||||0.0383|TWO_SIDED|95.0|1.06|6.92||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||6.92|1.06|0.0383
72357671|NCT03192176|144229975|SUPERIORITY||Odds Ratio (OR)|3.46||||0.0118|TWO_SIDED|95.0|1.32|9.1||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||9.10|1.32|0.0118
72357672|NCT03192176|144229975|SUPERIORITY||Odds Ratio (OR)|2.96||||0.0314|TWO_SIDED|95.0|1.1|7.97||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||7.97|1.10|0.0314
72357673|NCT03192176|144229975|SUPERIORITY||Odds Ratio (OR)|6.8||||0.001|TWO_SIDED|95.0|2.17|21.34||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||21.34|2.17|0.0010
72357674|NCT03192176|144229975|SUPERIORITY||Odds Ratio (OR)|2.24||||0.0956|TWO_SIDED|95.0|0.87|5.8||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||5.80|0.87|0.0956
72357675|NCT03192176|144229975|SUPERIORITY||Odds Ratio (OR)|4.8||||0.0027|TWO_SIDED|95.0|1.72|13.4||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||13.40|1.72|0.0027
72429312|NCT01154036|144369654|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.77||||0.007|TWO_SIDED|95.0|1.17|2.67|||Logistic Regression Model|Logistic regression model included terms for treatment and baseline LDL-C (where baseline LDL-C was fitted as 3 categories based on tertiles)||||2.67|1.17|0.007
72357676|NCT03192176|144229975|SUPERIORITY||Odds Ratio (OR)|2.41||||0.066|TWO_SIDED|95.0|0.94|6.14||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||6.14|0.94|0.0660
72357677|NCT03192176|144229975|SUPERIORITY||Odds Ratio (OR)|2.32||||0.0853|TWO_SIDED|95.0|0.89|6.05||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||6.05|0.89|0.0853
72357678|NCT03192176|144229975|SUPERIORITY||Odds Ratio (OR)|3.49||||0.0159|TWO_SIDED|95.0|1.26|9.62||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||9.62|1.26|0.0159
72357679|NCT03192176|144229975|SUPERIORITY||Odds Ratio (OR)|3.27||||0.0303|TWO_SIDED|95.0|1.12|9.53||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||9.53|1.12|0.0303
72357680|NCT03192176|144229975|SUPERIORITY||Odds Ratio (OR)|4.84||||0.0071|TWO_SIDED|95.0|1.54|15.28||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||15.28|1.54|0.0071
72357681|NCT03192176|144229975|SUPERIORITY||Odds Ratio (OR)|2.6||||0.0621|TWO_SIDED|95.0|0.95|7.09||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||7.09|0.95|0.0621
72357682|NCT03192176|144229975|SUPERIORITY||Odds Ratio (OR)|4.2||||0.0081|TWO_SIDED|95.0|1.45|12.15||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||12.15|1.45|0.0081
72357683|NCT03192176|144229975|SUPERIORITY||Odds Ratio (OR)|2.64||||0.0533|TWO_SIDED|95.0|0.99|7.09||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||7.09|0.99|0.0533
72357684|NCT03192176|144229975|SUPERIORITY||Odds Ratio (OR)|1.71||||0.2666|TWO_SIDED|95.0|0.66|4.42||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||4.42|0.66|0.2666
72357685|NCT03192176|144229975|SUPERIORITY||Odds Ratio (OR)|2.44||||0.0754|TWO_SIDED|95.0|0.91|6.52||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||6.52|0.91|0.0754
72357686|NCT03192176|144229975|SUPERIORITY||Odds Ratio (OR)|3.27||||0.0313|TWO_SIDED|95.0|1.11|9.64||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||9.64|1.11|0.0313
72357687|NCT03192176|144229975|SUPERIORITY||Odds Ratio (OR)|5.76||||0.0056|TWO_SIDED|95.0|1.67|19.88||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||19.88|1.67|0.0056
72357688|NCT03192176|144229975|SUPERIORITY||Odds Ratio (OR)|2.58||||0.0736|TWO_SIDED|95.0|0.91|7.28||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||7.28|0.91|0.0736
72357689|NCT03192176|144229975|SUPERIORITY||Odds Ratio (OR)|3.51||||0.0184|TWO_SIDED|95.0|1.24|10.0||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||10.00|1.24|0.0184
72357690|NCT03192176|144229975|SUPERIORITY||Odds Ratio (OR)|2.18||||0.1187|TWO_SIDED|95.0|0.82|5.81||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||5.81|0.82|0.1187
72357691|NCT03192176|144229975|SUPERIORITY||Odds Ratio (OR)|3.8||||0.0299|TWO_SIDED|95.0|1.14|12.69||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||12.69|1.14|0.0299
72357692|NCT03192176|144229975|SUPERIORITY||Odds Ratio (OR)|1.4||||0.5989|TWO_SIDED|95.0|0.4|4.89||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||4.89|0.40|0.5989
72357693|NCT03192176|144229975|SUPERIORITY||Odds Ratio (OR)|2.61||||0.1337|TWO_SIDED|95.0|0.74|9.14||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||9.14|0.74|0.1337
72429313|NCT01154036|144369655|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.71|||<|0.001|TWO_SIDED|95.0|1.55|4.73|||Logistic regression Model|Logistic regression model included terms for treatment and baseline LDL-C (where baseline LDL-C was fitted as 3 categories based on tertiles)||||4.73|1.55|<0.001
72357694|NCT03192176|144229975|SUPERIORITY||Odds Ratio (OR)|1.62||||0.4605|TWO_SIDED|95.0|0.45|5.89||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||5.89|0.45|0.4605
72357695|NCT03192176|144229975|SUPERIORITY||Odds Ratio (OR)|4.48||||0.0188|TWO_SIDED|95.0|1.28|15.65||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||15.65|1.28|0.0188
72357696|NCT03192176|144229975|SUPERIORITY||Odds Ratio (OR)|1.44||||0.5854|TWO_SIDED|95.0|0.39|5.42||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||5.42|0.39|0.5854
72357697|NCT03192176|144229975|SUPERIORITY||Odds Ratio (OR)|2.32||||0.1768|TWO_SIDED|95.0|0.68|7.86||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||7.86|0.68|0.1768
72357698|NCT03192176|144229975|SUPERIORITY||Odds Ratio (OR)|0.89||||0.8426|TWO_SIDED|95.0|0.29|2.78||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||2.78|0.29|0.8426
72357699|NCT03192176|144229975|SUPERIORITY||Odds Ratio (OR)|0.54||||0.3017|TWO_SIDED|95.0|0.17|1.73||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||1.73|0.17|0.3017
72357700|NCT03192176|144229975|SUPERIORITY||Odds Ratio (OR)|0.72||||0.5958|TWO_SIDED|95.0|0.21|2.43||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||2.43|0.21|0.5958
72357701|NCT03192176|144229975|SUPERIORITY||Odds Ratio (OR)|0.23||||0.0515|TWO_SIDED|95.0|0.05|1.01||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||1.01|0.05|0.0515
72357702|NCT03192176|144229975|SUPERIORITY||Odds Ratio (OR)|0.98||||0.9734|TWO_SIDED|95.0|0.31|3.11||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||3.11|0.31|0.9734
72357703|NCT03192176|144229975|SUPERIORITY||Odds Ratio (OR)|0.85||||0.7969|TWO_SIDED|95.0|0.25|2.93||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||2.93|0.25|0.7969
72357704|NCT03192176|144229975|SUPERIORITY||Odds Ratio (OR)|0.78||||0.6637|TWO_SIDED|95.0|0.25|2.4||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||2.40|0.25|0.6637
72357705|NCT03192176|144229975|SUPERIORITY||Odds Ratio (OR)|1.53||||0.4921|TWO_SIDED|95.0|0.45|5.15||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||5.15|0.45|0.4921
72357706|NCT03192176|144229975|SUPERIORITY||Odds Ratio (OR)|1.09||||0.891|TWO_SIDED|95.0|0.33|3.64||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||3.64|0.33|0.8910
72357707|NCT03192176|144229975|SUPERIORITY||Odds Ratio (OR)|0.68||||0.5881|TWO_SIDED|95.0|0.16|2.78||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||2.78|0.16|0.5881
72357708|NCT03192176|144229975|SUPERIORITY||Odds Ratio (OR)|0.11||||0.0523|TWO_SIDED|95.0|0.01|1.02||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||1.02|0.01|0.0523
72357709|NCT03192176|144229975|SUPERIORITY||Odds Ratio (OR)|1.6||||0.4646|TWO_SIDED|95.0|0.46|5.61||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||5.61|0.46|0.4646
72357710|NCT03192176|144229975|SUPERIORITY||Odds Ratio (OR)|1.43||||0.5806|TWO_SIDED|95.0|0.4|5.14||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||5.14|0.40|0.5806
72357711|NCT03192176|144229975|SUPERIORITY||Odds Ratio (OR)|0.94||||0.922|TWO_SIDED|95.0|0.28|3.12||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||3.12|0.28|0.9220
72357712|NCT03192176|144229976|SUPERIORITY||Odds Ratio (OR)|4.45||||0.1933|TWO_SIDED|95.0|0.47|42.25||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||42.25|0.47|0.1933
72357713|NCT03192176|144229976|SUPERIORITY||Odds Ratio (OR)|5.61||||0.124|TWO_SIDED|95.0|0.62|50.44||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||50.44|0.62|0.1240
72357714|NCT03192176|144229976|SUPERIORITY||Odds Ratio (OR)|14.16||||0.014|TWO_SIDED|95.0|1.71|117.2||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||117.2|1.71|0.0140
72357715|NCT03192176|144229976|SUPERIORITY||Odds Ratio (OR)|17.5||||0.0075|TWO_SIDED|95.0|2.15|142.7||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||142.7|2.15|0.0075
72357716|NCT03192176|144229976|SUPERIORITY||Odds Ratio (OR)|1.98||||0.5853|TWO_SIDED|95.0|0.17|22.96||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||22.96|0.17|0.5853
72357717|NCT03192176|144229976|SUPERIORITY||Odds Ratio (OR)|5.0||||0.1596|TWO_SIDED|95.0|0.53|47.05||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||47.05|0.53|0.1596
72357718|NCT03192176|144229976|SUPERIORITY||Odds Ratio (OR)|6.48||||0.0908|TWO_SIDED|95.0|0.74|56.51||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||56.51|0.74|0.0908
72357719|NCT03192176|144229976|SUPERIORITY||Odds Ratio (OR)|2.97||||0.1318|TWO_SIDED|95.0|0.72|12.19||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||12.19|0.72|0.1318
72357720|NCT03192176|144229976|SUPERIORITY||Odds Ratio (OR)|5.99||||0.0093|TWO_SIDED|95.0|1.56|23.04||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||23.04|1.56|0.0093
72357721|NCT03192176|144229976|SUPERIORITY||Odds Ratio (OR)|10.13||||0.0006|TWO_SIDED|95.0|2.69|38.22||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||38.22|2.69|0.0006
72357722|NCT03192176|144229976|SUPERIORITY||Odds Ratio (OR)|15.63|||<|0.0001|TWO_SIDED|95.0|4.11|59.4||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||59.40|4.11|<0.0001
72357723|NCT03192176|144229976|SUPERIORITY||Odds Ratio (OR)|2.53||||0.2054|TWO_SIDED|95.0|0.6|10.64||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||10.64|0.60|0.2054
72357724|NCT03192176|144229976|SUPERIORITY||Odds Ratio (OR)|2.8||||0.1592|TWO_SIDED|95.0|0.67|11.72||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||11.72|0.67|0.1592
72357725|NCT03192176|144229976|SUPERIORITY||Odds Ratio (OR)|6.31||||0.007|TWO_SIDED|95.0|1.66|24.07||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||24.07|1.66|0.0070
72357726|NCT03192176|144229976|SUPERIORITY||Odds Ratio (OR)|3.39||||0.0392|TWO_SIDED|95.0|1.06|10.85||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||10.85|1.06|0.0392
72357727|NCT03192176|144229976|SUPERIORITY||Odds Ratio (OR)|4.49||||0.0096|TWO_SIDED|95.0|1.44|13.96||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||13.96|1.44|0.0096
72357728|NCT03192176|144229976|SUPERIORITY||Odds Ratio (OR)|10.11|||<|0.0001|TWO_SIDED|95.0|3.28|31.16||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||31.16|3.28|<0.0001
72357729|NCT03192176|144229976|SUPERIORITY||Odds Ratio (OR)|11.76|||<|0.0001|TWO_SIDED|95.0|3.75|36.9||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||36.90|3.75|<0.0001
72357730|NCT03192176|144229976|SUPERIORITY||Odds Ratio (OR)|2.11||||0.2217|TWO_SIDED|95.0|0.64|7.03||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||7.03|0.64|0.2217
72429314|NCT01154036|144369655|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.38|||<|0.001|TWO_SIDED|95.0|1.56|3.63|||Logistic Regression Model|Logistic regression model included terms for treatment and baseline LDL-C (where baseline LDL-C was fitted as 3 categories based on tertiles)||||3.63|1.56|<0.001
72357731|NCT03192176|144229976|SUPERIORITY||Odds Ratio (OR)|4.26||||0.0131|TWO_SIDED|95.0|1.36|13.38||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||13.38|1.36|0.0131
72357732|NCT03192176|144229976|SUPERIORITY||Odds Ratio (OR)|5.39||||0.0031|TWO_SIDED|95.0|1.76|16.46||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||16.46|1.76|0.0031
72357733|NCT03192176|144229976|SUPERIORITY||Odds Ratio (OR)|2.15||||0.1485|TWO_SIDED|95.0|0.76|6.1||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||6.10|0.76|0.1485
72357734|NCT03192176|144229976|SUPERIORITY||Odds Ratio (OR)|3.54||||0.0128|TWO_SIDED|95.0|1.31|9.56||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||9.56|1.31|0.0128
72357735|NCT03192176|144229976|SUPERIORITY||Odds Ratio (OR)|6.5||||0.0003|TWO_SIDED|95.0|2.37|17.81||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||17.81|2.37|0.0003
72357736|NCT03192176|144229976|SUPERIORITY||Odds Ratio (OR)|6.42||||0.0003|TWO_SIDED|95.0|2.32|17.77||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||17.77|2.32|0.0003
72357737|NCT03192176|144229976|SUPERIORITY||Odds Ratio (OR)|1.87||||0.2354|TWO_SIDED|95.0|0.67|5.26||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||5.26|0.67|0.2354
72357738|NCT03192176|144229976|SUPERIORITY||Odds Ratio (OR)|2.41||||0.0894|TWO_SIDED|95.0|0.87|6.65||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||6.65|0.87|0.0894
72357739|NCT03192176|144229976|SUPERIORITY||Odds Ratio (OR)|3.23||||0.0201|TWO_SIDED|95.0|1.2|8.67||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||8.67|1.20|0.0201
72357740|NCT03192176|144229976|SUPERIORITY||Odds Ratio (OR)|2.1||||0.1614|TWO_SIDED|95.0|0.74|5.94||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||5.94|0.74|0.1614
72357741|NCT03192176|144229976|SUPERIORITY||Odds Ratio (OR)|3.57||||0.0123|TWO_SIDED|95.0|1.32|9.66||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||9.66|1.32|0.0123
72357742|NCT03192176|144229976|SUPERIORITY||Odds Ratio (OR)|6.08||||0.0006|TWO_SIDED|95.0|2.17|17.03||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||17.03|2.17|0.0006
72357743|NCT03192176|144229976|SUPERIORITY||Odds Ratio (OR)|9.82|||<|0.0001|TWO_SIDED|95.0|3.4|28.36||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||28.36|3.40|<0.0001
72357744|NCT03192176|144229976|SUPERIORITY||Odds Ratio (OR)|2.08||||0.1609|TWO_SIDED|95.0|0.75|5.81||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||5.81|0.75|0.1609
72357745|NCT03192176|144229976|SUPERIORITY||Odds Ratio (OR)|2.42||||0.093|TWO_SIDED|95.0|0.86|6.79||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||6.79|0.86|0.0930
72357746|NCT03192176|144229976|SUPERIORITY||Odds Ratio (OR)|4.02||||0.0063|TWO_SIDED|95.0|1.48|10.91||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||10.91|1.48|0.0063
72357747|NCT03192176|144229976|SUPERIORITY||Odds Ratio (OR)|1.76||||0.2621|TWO_SIDED|95.0|0.65|4.74||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||4.74|0.65|0.2621
72357748|NCT03192176|144229976|SUPERIORITY||Odds Ratio (OR)|3.55||||0.0092|TWO_SIDED|95.0|1.37|9.21||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||9.21|1.37|0.0092
72429315|NCT01154036|144369656|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|9.46|||<|0.001|TWO_SIDED|95.0|4.56|19.62|||Logistic Regression Model|Logistic regression model included terms for treatment and baseline LDL-C (where baseline LDL-C was fitted as 3 categories based on tertiles)||||19.62|4.56|<0.001
72357749|NCT03192176|144229976|SUPERIORITY||Odds Ratio (OR)|5.69||||0.0007|TWO_SIDED|95.0|2.09|15.48||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||15.48|2.09|0.0007
72357750|NCT03192176|144229976|SUPERIORITY||Odds Ratio (OR)|8.85|||<|0.0001|TWO_SIDED|95.0|3.08|25.43||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||25.43|3.08|<0.0001
72357751|NCT03192176|144229976|SUPERIORITY||Odds Ratio (OR)|1.5||||0.4259|TWO_SIDED|95.0|0.55|4.08||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||4.08|0.55|0.4259
72357752|NCT03192176|144229976|SUPERIORITY||Odds Ratio (OR)|2.13||||0.1334|TWO_SIDED|95.0|0.79|5.74||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||5.74|0.79|0.1334
72357753|NCT03192176|144229976|SUPERIORITY||Odds Ratio (OR)|3.39||||0.012|TWO_SIDED|95.0|1.31|8.77||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||8.77|1.31|0.0120
72357754|NCT03192176|144229976|SUPERIORITY||Odds Ratio (OR)|1.84||||0.2443|TWO_SIDED|95.0|0.66|5.1||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||5.10|0.66|0.2443
72357755|NCT03192176|144229976|SUPERIORITY||Odds Ratio (OR)|4.6||||0.0022|TWO_SIDED|95.0|1.73|12.25||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||12.25|1.73|0.0022
72357756|NCT03192176|144229976|SUPERIORITY||Odds Ratio (OR)|6.6||||0.0004|TWO_SIDED|95.0|2.35|18.58||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||18.58|2.35|0.0004
72357757|NCT03192176|144229976|SUPERIORITY||Odds Ratio (OR)|12.17|||<|0.0001|TWO_SIDED|95.0|4.05|36.63||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||36.63|4.05|<0.0001
72357758|NCT03192176|144229976|SUPERIORITY||Odds Ratio (OR)|1.7||||0.3101|TWO_SIDED|95.0|0.61|4.71||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||4.71|0.61|0.3101
72357759|NCT03192176|144229976|SUPERIORITY||Odds Ratio (OR)|3.65||||0.0116|TWO_SIDED|95.0|1.34|10.0||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||10.00|1.34|0.0116
72357760|NCT03192176|144229976|SUPERIORITY||Odds Ratio (OR)|4.15||||0.0045|TWO_SIDED|95.0|1.56|11.05||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||11.05|1.56|0.0045
72357761|NCT03192176|144229976|SUPERIORITY||Odds Ratio (OR)|1.55||||0.3505|TWO_SIDED|95.0|0.62|3.88||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||3.88|0.62|0.3505
72357762|NCT03192176|144229976|SUPERIORITY||Odds Ratio (OR)|2.28||||0.0739|TWO_SIDED|95.0|0.92|5.62||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||5.62|0.92|0.0739
72357763|NCT03192176|144229976|SUPERIORITY||Odds Ratio (OR)|3.19||||0.0163|TWO_SIDED|95.0|1.24|8.2||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||8.20|1.24|0.0163
72357764|NCT03192176|144229976|SUPERIORITY||Odds Ratio (OR)|8.49||||0.0001|TWO_SIDED|95.0|2.81|25.64||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||25.64|2.81|0.0001
72357765|NCT03192176|144229976|SUPERIORITY||Odds Ratio (OR)|0.9||||0.8358|TWO_SIDED|95.0|0.35|2.35||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||2.35|0.35|0.8358
72357766|NCT03192176|144229976|SUPERIORITY||Odds Ratio (OR)|2.18||||0.1006|TWO_SIDED|95.0|0.86|5.52||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||5.52|0.86|0.1006
72429316|NCT01154036|144369656|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|3.9|||<|0.001|TWO_SIDED|95.0|2.23|6.82|||Logistic Regression Model|Logistic regression model included terms for treatment and baseline LDL-C (where baseline LDL-C was fitted as 3 categories based on tertiles)||||6.82|2.23|<0.001
72357767|NCT03192176|144229976|SUPERIORITY||Odds Ratio (OR)|2.53||||0.0484|TWO_SIDED|95.0|1.01|6.34||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||6.34|1.01|0.0484
72357768|NCT03192176|144229976|SUPERIORITY||Odds Ratio (OR)|1.24||||0.6492|TWO_SIDED|95.0|0.5|3.08||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||3.08|0.50|0.6492
72357769|NCT03192176|144229976|SUPERIORITY||Odds Ratio (OR)|1.74||||0.223|TWO_SIDED|95.0|0.71|4.27||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||4.27|0.71|0.2230
72357770|NCT03192176|144229976|SUPERIORITY||Odds Ratio (OR)|3.43||||0.0126|TWO_SIDED|95.0|1.3|9.02||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||9.02|1.30|0.0126
72357771|NCT03192176|144229976|SUPERIORITY||Odds Ratio (OR)|5.56||||0.0014|TWO_SIDED|95.0|1.94|15.98||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||15.98|1.94|0.0014
72357772|NCT03192176|144229976|SUPERIORITY||Odds Ratio (OR)|0.7||||0.4713|TWO_SIDED|95.0|0.27|1.83||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||1.83|0.27|0.4713
72357773|NCT03192176|144229976|SUPERIORITY||Odds Ratio (OR)|2.02||||0.1397|TWO_SIDED|95.0|0.79|5.12||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||5.12|0.79|0.1397
72357774|NCT03192176|144229976|SUPERIORITY||Odds Ratio (OR)|1.75||||0.2272|TWO_SIDED|95.0|0.71|4.34||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||4.34|0.71|0.2272
72357775|NCT03192176|144229976|SUPERIORITY||Odds Ratio (OR)|1.83||||0.2024|TWO_SIDED|95.0|0.72|4.64||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||4.64|0.72|0.2024
72357776|NCT03192176|144229976|SUPERIORITY||Odds Ratio (OR)|1.9||||0.1716|TWO_SIDED|95.0|0.76|4.79||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||4.79|0.76|0.1716
72357777|NCT03192176|144229976|SUPERIORITY||Odds Ratio (OR)|3.2||||0.0199|TWO_SIDED|95.0|1.2|8.51||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||8.51|1.20|0.0199
72357778|NCT03192176|144229976|SUPERIORITY||Odds Ratio (OR)|8.45||||0.0002|TWO_SIDED|95.0|2.8|25.54||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||25.54|2.80|0.0002
72357779|NCT03192176|144229976|SUPERIORITY||Odds Ratio (OR)|1.47||||0.4243|TWO_SIDED|95.0|0.57|3.77||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||3.77|0.57|0.4243
72357780|NCT03192176|144229976|SUPERIORITY||Odds Ratio (OR)|1.99||||0.1507|TWO_SIDED|95.0|0.78|5.09||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||5.09|0.78|0.1507
72357781|NCT03192176|144229976|SUPERIORITY||Odds Ratio (OR)|2.6||||0.0449|TWO_SIDED|95.0|1.02|6.6||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||6.60|1.02|0.0449
72357782|NCT03192176|144229976|SUPERIORITY||Odds Ratio (OR)|1.68||||0.2759|TWO_SIDED|95.0|0.66|4.24||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||4.24|0.66|0.2759
72357783|NCT03192176|144229976|SUPERIORITY||Odds Ratio (OR)|1.9||||0.17|TWO_SIDED|95.0|0.76|4.78||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||4.78|0.76|0.1700
72357784|NCT03192176|144229976|SUPERIORITY||Odds Ratio (OR)|3.47||||0.0153|TWO_SIDED|95.0|1.27|9.51||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||9.51|1.27|0.0153
72429317|NCT01154036|144369657|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|27.77||||0.001|TWO_SIDED|95.0|3.64|211.83|||Logistic Regression Model|Logistic regression model included terms for treatment and baseline LDL-C (where baseline LDL-C was fitted as 3 categories based on tertiles)||||211.83|3.64|0.001
72357785|NCT03192176|144229976|SUPERIORITY||Odds Ratio (OR)|6.04||||0.0009|TWO_SIDED|95.0|2.08|17.53||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||17.53|2.08|0.0009
72357786|NCT03192176|144229976|SUPERIORITY||Odds Ratio (OR)|1.27||||0.6228|TWO_SIDED|95.0|0.5|3.23||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||3.23|0.50|0.6228
72357787|NCT03192176|144229976|SUPERIORITY||Odds Ratio (OR)|2.62||||0.046|TWO_SIDED|95.0|1.02|6.76||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||6.76|1.02|0.0460
72357788|NCT03192176|144229976|SUPERIORITY||Odds Ratio (OR)|2.07||||0.1215|TWO_SIDED|95.0|0.82|5.23||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||5.23|0.82|0.1215
72357789|NCT03192176|144229976|SUPERIORITY||Odds Ratio (OR)|1.75||||0.247|TWO_SIDED|95.0|0.68|4.48||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||4.48|0.68|0.2470
72357790|NCT03192176|144229976|SUPERIORITY||Odds Ratio (OR)|1.83||||0.2072|TWO_SIDED|95.0|0.72|4.66||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||4.66|0.72|0.2072
72357791|NCT03192176|144229976|SUPERIORITY||Odds Ratio (OR)|2.57||||0.0621|TWO_SIDED|95.0|0.95|6.94||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||6.94|0.95|0.0621
72357792|NCT03192176|144229976|SUPERIORITY||Odds Ratio (OR)|5.67||||0.0016|TWO_SIDED|95.0|1.93|16.69||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||16.69|1.93|0.0016
72357793|NCT03192176|144229976|SUPERIORITY||Odds Ratio (OR)|1.47||||0.4372|TWO_SIDED|95.0|0.56|3.84||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||3.84|0.56|0.4372
72357794|NCT03192176|144229976|SUPERIORITY||Odds Ratio (OR)|2.18||||0.11|TWO_SIDED|95.0|0.84|5.66||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||5.66|0.84|0.1100
72357795|NCT03192176|144229976|SUPERIORITY||Odds Ratio (OR)|2.55||||0.0533|TWO_SIDED|95.0|0.99|6.59||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||6.59|0.99|0.0533
72357796|NCT03192176|144229976|SUPERIORITY||Odds Ratio (OR)|4.68||||0.1769|TWO_SIDED|95.0|0.5|44.0||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||44.00|0.50|0.1769
72357797|NCT03192176|144229976|SUPERIORITY||Odds Ratio (OR)|2.26||||0.4942|TWO_SIDED|95.0|0.22|23.53||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||23.53|0.22|0.4942
72357798|NCT03192176|144229976|SUPERIORITY||Odds Ratio (OR)|12.82||||0.0214|TWO_SIDED|95.0|1.46|112.7||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||112.7|1.46|0.0214
72357799|NCT03192176|144229976|SUPERIORITY||Odds Ratio (OR)|1.93||||0.6013|TWO_SIDED|95.0|0.16|22.99||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||22.99|0.16|0.6013
72357800|NCT03192176|144229976|SUPERIORITY||Odds Ratio (OR)|8.6||||0.0537|TWO_SIDED|95.0|0.97|76.58||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||76.58|0.97|0.0537
72357801|NCT03192176|144229976|SUPERIORITY||Odds Ratio (OR)|3.8||||0.2662|TWO_SIDED|95.0|0.36|39.91||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||39.91|0.36|0.2662
72357802|NCT03192176|144229976|SUPERIORITY||Odds Ratio (OR)|1.51||||0.7431|TWO_SIDED|95.0|0.13|17.84||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||17.84|0.13|0.7431
72429318|NCT01154036|144369657|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|7.08|||<|0.001|TWO_SIDED|95.0|2.85|17.56|||Logistic Regression Model|Logistic regression model included terms for treatment and baseline LDL-C (where baseline LDL-C was fitted as 3 categories based on tertiles)||||17.56|2.85|<0.001
72357803|NCT03192176|144229976|SUPERIORITY||Odds Ratio (OR)|3.53||||0.2829|TWO_SIDED|95.0|0.35|35.22||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||35.22|0.35|0.2829
72357804|NCT03192176|144229976|SUPERIORITY||Odds Ratio (OR)|2.12||||0.5311|TWO_SIDED|95.0|0.2|22.29||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||22.29|0.20|0.5311
72357805|NCT03192176|144229976|SUPERIORITY||Odds Ratio (OR)|4.71||||0.1857|TWO_SIDED|95.0|0.47|46.83||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||46.83|0.47|0.1857
72357806|NCT03192176|144229976|SUPERIORITY||Odds Ratio (OR)|1.02||||0.9879|TWO_SIDED|95.0|0.06|17.5||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||17.50|0.06|0.9879
72357807|NCT03192176|144229976|SUPERIORITY||Odds Ratio (OR)|4.57||||0.1853|TWO_SIDED|95.0|0.48|43.19||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||43.19|0.48|0.1853
72357808|NCT03192176|144229976|SUPERIORITY||Odds Ratio (OR)|4.43||||0.217|TWO_SIDED|95.0|0.42|46.93||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||46.93|0.42|0.2170
72357809|NCT03192176|144229976|SUPERIORITY||Odds Ratio (OR)|0.74||||0.8354|TWO_SIDED|95.0|0.04|12.62||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||12.62|0.04|0.8354
72357810|NCT03192176|144229977|SUPERIORITY||Odds Ratio (OR)|0.94||||0.9671|TWO_SIDED|95.0|0.06|16.04||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||16.04|0.06|0.9671
72357811|NCT03192176|144229977|SUPERIORITY||Odds Ratio (OR)|3.16||||0.3289|TWO_SIDED|95.0|0.31|31.87||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||31.87|0.31|0.3289
72357812|NCT03192176|144229977|SUPERIORITY||Odds Ratio (OR)|3.26||||0.3157|TWO_SIDED|95.0|0.32|32.71||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||32.71|0.32|0.3157
72357813|NCT03192176|144229977|SUPERIORITY||Odds Ratio (OR)|1.0||||0.991|TWO_SIDED|95.0|0.06|16.83||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||16.83|0.06|0.991
72357814|NCT03192176|144229977|SUPERIORITY||Odds Ratio (OR)|2.26||||0.5139|TWO_SIDED|95.0|0.2|26.12||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||26.12|0.20|0.5139
72357815|NCT03192176|144229977|SUPERIORITY||Odds Ratio (OR)|3.32||||0.3079|TWO_SIDED|95.0|0.33|33.45||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||33.45|0.33|0.3079
72357816|NCT03192176|144229977|SUPERIORITY||Odds Ratio (OR)|8.83||||0.0469|TWO_SIDED|95.0|1.03|75.68||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||75.68|1.03|0.0469
72357817|NCT03192176|144229977|SUPERIORITY||Odds Ratio (OR)|14.39||||0.0134|TWO_SIDED|95.0|1.74|119.1||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||119.1|1.74|0.0134
72357818|NCT03192176|144229977|SUPERIORITY||Odds Ratio (OR)|4.98||||0.1606|TWO_SIDED|95.0|0.53|46.9||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||46.90|0.53|0.1606
72357819|NCT03192176|144229977|SUPERIORITY||Odds Ratio (OR)|6.69||||0.0854|TWO_SIDED|95.0|0.77|58.35||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||58.35|0.77|0.0854
72357820|NCT03192176|144229977|SUPERIORITY||Odds Ratio (OR)|6.07||||0.1082|TWO_SIDED|95.0|0.67|54.72||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||54.72|0.67|0.1082
72429319|NCT01154036|144369658|SUPERIORITY_OR_OTHER_LEGACY||Difference in M-estimates|-7.1|||<|0.001|TWO_SIDED|95.0|-9.7|-4.4|||Multiple Imputation Robust Regression|M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values||||-4.4|-9.7|<0.001
72357821|NCT03192176|144229977|SUPERIORITY||Odds Ratio (OR)|7.22||||0.0737|TWO_SIDED|95.0|0.83|63.04||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||63.04|0.83|0.0737
72357822|NCT03192176|144229977|SUPERIORITY||Odds Ratio (OR)|11.98||||0.0217|TWO_SIDED|95.0|1.44|99.74||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||99.74|1.44|0.0217
72357823|NCT03192176|144229977|SUPERIORITY||Odds Ratio (OR)|19.24||||0.0058|TWO_SIDED|95.0|2.36|157.1||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||157.1|2.36|0.0058
72357824|NCT03192176|144229977|SUPERIORITY||Odds Ratio (OR)|4.44||||0.1924|TWO_SIDED|95.0|0.47|41.87||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||41.87|0.47|0.1924
72357825|NCT03192176|144229977|SUPERIORITY||Odds Ratio (OR)|7.54||||0.068|TWO_SIDED|95.0|0.86|66.0||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||66.00|0.86|0.0680
72357826|NCT03192176|144229977|SUPERIORITY||Odds Ratio (OR)|15.95||||0.0095|TWO_SIDED|95.0|1.97|129.4||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||129.4|1.97|0.0095
72357827|NCT03192176|144229977|SUPERIORITY||Odds Ratio (OR)|3.68||||0.269|TWO_SIDED|95.0|0.36|37.21||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||37.21|0.36|0.2690
72357828|NCT03192176|144229977|SUPERIORITY||Odds Ratio (OR)|10.28||||0.0321|TWO_SIDED|95.0|1.22|86.53||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||86.53|1.22|0.0321
72357829|NCT03192176|144229977|SUPERIORITY||Odds Ratio (OR)|14.48||||0.0131|TWO_SIDED|95.0|1.75|119.7||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||119.7|1.75|0.0131
72357830|NCT03192176|144229977|SUPERIORITY||Odds Ratio (OR)|25.22||||0.0025|TWO_SIDED|95.0|3.11|204.6||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||204.6|3.11|0.0025
72357831|NCT03192176|144229977|SUPERIORITY||Odds Ratio (OR)|4.65||||0.1788|TWO_SIDED|95.0|0.49|43.72||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||43.72|0.49|0.1788
72357832|NCT03192176|144229977|SUPERIORITY||Odds Ratio (OR)|10.33||||0.032|TWO_SIDED|95.0|1.22|87.31||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||87.31|1.22|0.0320
72357833|NCT03192176|144229977|SUPERIORITY||Odds Ratio (OR)|11.24||||0.0251|TWO_SIDED|95.0|1.35|93.33||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||93.33|1.35|0.0251
72357834|NCT03192176|144229977|SUPERIORITY||Odds Ratio (OR)|1.43||||0.6154|TWO_SIDED|95.0|0.35|5.83||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||5.83|0.35|0.6154
72357835|NCT03192176|144229977|SUPERIORITY||Odds Ratio (OR)|2.37||||0.1906|TWO_SIDED|95.0|0.65|8.63||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||8.63|0.65|0.1906
72357836|NCT03192176|144229977|SUPERIORITY||Odds Ratio (OR)|3.67||||0.045|TWO_SIDED|95.0|1.03|13.07||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||13.07|1.03|0.0450
72357837|NCT03192176|144229977|SUPERIORITY||Odds Ratio (OR)|7.19||||0.0017|TWO_SIDED|95.0|2.1|24.66||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||24.66|2.10|0.0017
72357838|NCT03192176|144229977|SUPERIORITY||Odds Ratio (OR)|1.8||||0.3939|TWO_SIDED|95.0|0.47|6.97||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||6.97|0.47|0.3939
72357839|NCT03192176|144229977|SUPERIORITY||Odds Ratio (OR)|2.06||||0.2869|TWO_SIDED|95.0|0.55|7.74||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||7.74|0.55|0.2869
72357840|NCT03192176|144229977|SUPERIORITY||Odds Ratio (OR)|2.41||||0.1817|TWO_SIDED|95.0|0.66|8.8||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||8.80|0.66|0.1817
72357841|NCT03192176|144229977|SUPERIORITY||Odds Ratio (OR)|11.41||||0.0256|TWO_SIDED|95.0|1.35|96.77||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||96.77|1.35|0.0256
72357842|NCT03192176|144229977|SUPERIORITY||Odds Ratio (OR)|13.65||||0.0153|TWO_SIDED|95.0|1.65|112.8||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||112.8|1.65|0.0153
72357843|NCT03192176|144229977|SUPERIORITY||Odds Ratio (OR)|21.76||||0.0042|TWO_SIDED|95.0|2.64|179.2||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||179.2|2.64|0.0042
72357844|NCT03192176|144229977|SUPERIORITY||Odds Ratio (OR)|35.75||||0.0008|TWO_SIDED|95.0|4.39|291.5||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||291.5|4.39|0.0008
72357845|NCT03192176|144229977|SUPERIORITY||Odds Ratio (OR)|6.45||||0.0967|TWO_SIDED|95.0|0.71|58.21||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||58.21|0.71|0.0967
72357846|NCT03192176|144229977|SUPERIORITY||Odds Ratio (OR)|8.3||||0.0564|TWO_SIDED|95.0|0.94|72.95||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||72.95|0.94|0.0564
72357847|NCT03192176|144229977|SUPERIORITY||Odds Ratio (OR)|23.63||||0.003|TWO_SIDED|95.0|2.93|190.5||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||190.5|2.93|0.0030
72357848|NCT03192176|144229977|SUPERIORITY||Odds Ratio (OR)|9.72||||0.0384|TWO_SIDED|95.0|1.13|83.68||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||83.68|1.13|0.0384
72357849|NCT03192176|144229977|SUPERIORITY||Odds Ratio (OR)|13.65||||0.0153|TWO_SIDED|95.0|1.65|112.9||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||112.9|1.65|0.0153
72357850|NCT03192176|144229977|SUPERIORITY||Odds Ratio (OR)|30.55||||0.0015|TWO_SIDED|95.0|3.72|250.6||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||250.6|3.72|0.0015
72357851|NCT03192176|144229977|SUPERIORITY||Odds Ratio (OR)|35.99||||0.0008|TWO_SIDED|95.0|4.41|293.5||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||293.5|4.41|0.0008
72357852|NCT03192176|144229977|SUPERIORITY||Odds Ratio (OR)|12.67||||0.0192|TWO_SIDED|95.0|1.51|106.1||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||106.1|1.51|0.0192
72357853|NCT03192176|144229977|SUPERIORITY||Odds Ratio (OR)|16.92||||0.0089|TWO_SIDED|95.0|2.03|141.0||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||141.0|2.03|0.0089
72357854|NCT03192176|144229977|SUPERIORITY||Odds Ratio (OR)|24.96||||0.0025|TWO_SIDED|95.0|3.09|201.6||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||201.6|3.09|0.0025
72357855|NCT03192176|144229977|SUPERIORITY||Odds Ratio (OR)|3.03||||0.091|TWO_SIDED|95.0|0.84|10.94||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||10.94|0.84|0.0910
72357856|NCT03192176|144229977|SUPERIORITY||Odds Ratio (OR)|3.96||||0.0296|TWO_SIDED|95.0|1.15|13.67||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||13.67|1.15|0.0296
72357857|NCT03192176|144229977|SUPERIORITY||Odds Ratio (OR)|8.23||||0.0009|TWO_SIDED|95.0|2.38|28.44||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||28.44|2.38|0.0009
72357858|NCT03192176|144229977|SUPERIORITY||Odds Ratio (OR)|8.54||||0.0007|TWO_SIDED|95.0|2.46|29.63||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||29.63|2.46|0.0007
72357859|NCT03192176|144229977|SUPERIORITY||Odds Ratio (OR)|1.76||||0.4152|TWO_SIDED|95.0|0.45|6.86||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||6.86|0.45|0.4152
72357860|NCT03192176|144229977|SUPERIORITY||Odds Ratio (OR)|3.29||||0.07|TWO_SIDED|95.0|0.91|11.93||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||11.93|0.91|0.0700
72357861|NCT03192176|144229977|SUPERIORITY||Odds Ratio (OR)|5.83||||0.0048|TWO_SIDED|95.0|1.71|19.84||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||19.84|1.71|0.0048
72357862|NCT03192176|144229977|SUPERIORITY||Odds Ratio (OR)|2.44||||0.1497|TWO_SIDED|95.0|0.72|8.23||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||8.23|0.72|0.1497
72357863|NCT03192176|144229977|SUPERIORITY||Odds Ratio (OR)|3.05||||0.0608|TWO_SIDED|95.0|0.95|9.77||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||9.77|0.95|0.0608
72357864|NCT03192176|144229977|SUPERIORITY||Odds Ratio (OR)|5.99||||0.0028|TWO_SIDED|95.0|1.85|19.34||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||19.34|1.85|0.0028
72357865|NCT03192176|144229977|SUPERIORITY||Odds Ratio (OR)|7.84||||0.0005|TWO_SIDED|95.0|2.45|25.13||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||25.13|2.45|0.0005
72357866|NCT03192176|144229977|SUPERIORITY||Odds Ratio (OR)|1.15||||0.8393|TWO_SIDED|95.0|0.3|4.39||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||4.39|0.30|0.8393
72357867|NCT03192176|144229977|SUPERIORITY||Odds Ratio (OR)|4.01||||0.0215|TWO_SIDED|95.0|1.23|13.1||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||13.10|1.23|0.0215
72357868|NCT03192176|144229977|SUPERIORITY||Odds Ratio (OR)|4.42||||0.0112|TWO_SIDED|95.0|1.4|13.94||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||13.94|1.40|0.0112
72357869|NCT03192176|144229977|SUPERIORITY||Odds Ratio (OR)|1.71||||0.3498|TWO_SIDED|95.0|0.55|5.29||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||5.29|0.55|0.3498
72357870|NCT03192176|144229977|SUPERIORITY||Odds Ratio (OR)|2.05||||0.1981|TWO_SIDED|95.0|0.69|6.08||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||6.08|0.69|0.1981
72357871|NCT03192176|144229977|SUPERIORITY||Odds Ratio (OR)|5.28||||0.0029|TWO_SIDED|95.0|1.76|15.78||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||15.78|1.76|0.0029
72357872|NCT03192176|144229977|SUPERIORITY||Odds Ratio (OR)|5.95||||0.0011|TWO_SIDED|95.0|2.03|17.4||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||17.40|2.03|0.0011
72357873|NCT03192176|144229977|SUPERIORITY||Odds Ratio (OR)|0.96||||0.9511|TWO_SIDED|95.0|0.29|3.23||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||3.23|0.29|0.9511
72357874|NCT03192176|144229977|SUPERIORITY||Odds Ratio (OR)|1.76||||0.3241|TWO_SIDED|95.0|0.57|5.45||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||5.45|0.57|0.3241
72429320|NCT01154036|144369658|SUPERIORITY_OR_OTHER_LEGACY||Difference in M-estimates|-5.8|||<|0.001|TWO_SIDED|95.0|-8.3|-3.3|||Multiple Imputation Robust Regression|M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values||||-3.3|-8.3|<0.001
72357875|NCT03192176|144229977|SUPERIORITY||Odds Ratio (OR)|3.9||||0.0111|TWO_SIDED|95.0|1.36|11.16||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||11.16|1.36|0.0111
72357876|NCT03192176|144229977|SUPERIORITY||Odds Ratio (OR)|2.51||||0.1375|TWO_SIDED|95.0|0.74|8.48||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||8.48|0.74|0.1375
72357877|NCT03192176|144229977|SUPERIORITY||Odds Ratio (OR)|3.02||||0.067|TWO_SIDED|95.0|0.93|9.83||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||9.83|0.93|0.0670
72357878|NCT03192176|144229977|SUPERIORITY||Odds Ratio (OR)|7.57||||0.0009|TWO_SIDED|95.0|2.29|25.04||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||25.04|2.29|0.0009
72357879|NCT03192176|144229977|SUPERIORITY||Odds Ratio (OR)|9.42||||0.0002|TWO_SIDED|95.0|2.91|30.49||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||30.49|2.91|0.0002
72357880|NCT03192176|144229977|SUPERIORITY||Odds Ratio (OR)|2.75||||0.0982|TWO_SIDED|95.0|0.83|9.14||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||9.14|0.83|0.0982
72357881|NCT03192176|144229977|SUPERIORITY||Odds Ratio (OR)|2.6||||0.1233|TWO_SIDED|95.0|0.77|8.8||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||8.80|0.77|0.1233
72357882|NCT03192176|144229977|SUPERIORITY||Odds Ratio (OR)|4.63||||0.0091|TWO_SIDED|95.0|1.46|14.64||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||14.64|1.46|0.0091
72357883|NCT03192176|144229977|SUPERIORITY||Odds Ratio (OR)|1.03||||0.962|TWO_SIDED|95.0|0.34|3.1||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||3.10|0.34|0.9620
72357884|NCT03192176|144229977|SUPERIORITY||Odds Ratio (OR)|1.63||||0.3527|TWO_SIDED|95.0|0.58|4.59||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||4.59|0.58|0.3527
72357885|NCT03192176|144229977|SUPERIORITY||Odds Ratio (OR)|3.04||||0.0394|TWO_SIDED|95.0|1.06|8.76||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||8.76|1.06|0.0394
72357886|NCT03192176|144229977|SUPERIORITY||Odds Ratio (OR)|3.36||||0.0224|TWO_SIDED|95.0|1.19|9.53||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||9.53|1.19|0.0224
72357887|NCT03192176|144229977|SUPERIORITY||Odds Ratio (OR)|1.16||||0.7891|TWO_SIDED|95.0|0.39|3.44||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||3.44|0.39|0.7891
72357888|NCT03192176|144229977|SUPERIORITY||Odds Ratio (OR)|2.48||||0.0851|TWO_SIDED|95.0|0.88|6.99||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||6.99|0.88|0.0851
72357889|NCT03192176|144229977|SUPERIORITY||Odds Ratio (OR)|1.74||||0.2885|TWO_SIDED|95.0|0.63|4.83||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||4.83|0.63|0.2885
72357890|NCT03192176|144229977|SUPERIORITY||Odds Ratio (OR)|0.78||||0.8611|TWO_SIDED|95.0|0.05|13.3||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||13.30|0.05|0.8611
72357891|NCT03192176|144229977|SUPERIORITY||Odds Ratio (OR)|1.48||||0.7549|TWO_SIDED|95.0|0.13|17.42||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||17.42|0.13|0.7549
72357892|NCT03192176|144229977|SUPERIORITY||Odds Ratio (OR)|2.07||||0.5658|TWO_SIDED|95.0|0.17|24.66||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||24.66|0.17|0.5658
72429321|NCT01154036|144369659|SUPERIORITY_OR_OTHER_LEGACY||Difference in M-estimates|-6.8|||<|0.001|TWO_SIDED|95.0|-10.7|-3.0|||Multiple Imputation Robust Regression|M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values||||-3.0|-10.7|<0.001
72357893|NCT03192176|144229977|SUPERIORITY||Odds Ratio (OR)|1.83||||0.6319|TWO_SIDED|95.0|0.15|21.86||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||21.86|0.15|0.6319
72357894|NCT03192176|144229977|SUPERIORITY||Odds Ratio (OR)|1.09||||0.9526|TWO_SIDED|95.0|0.06|18.96||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||18.96|0.06|0.9526
72357895|NCT03192176|144229978|SUPERIORITY||Odds Ratio (OR)|1.74||||0.2251|TWO_SIDED|95.0|0.71|4.26||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||4.26|0.71|0.2251
72357896|NCT03192176|144229978|SUPERIORITY||Odds Ratio (OR)|3.57||||0.0084|TWO_SIDED|95.0|1.39|9.2||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||9.20|1.39|0.0084
72357897|NCT03192176|144229978|SUPERIORITY||Odds Ratio (OR)|5.71||||0.0007|TWO_SIDED|95.0|2.09|15.62||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||15.62|2.09|0.0007
72357898|NCT03192176|144229978|SUPERIORITY||Odds Ratio (OR)|5.11||||0.0015|TWO_SIDED|95.0|1.87|14.0||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||14.00|1.87|0.0015
72357899|NCT03192176|144229978|SUPERIORITY||Odds Ratio (OR)|1.2||||0.6976|TWO_SIDED|95.0|0.48|2.95||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||2.95|0.48|0.6976
72357900|NCT03192176|144229978|SUPERIORITY||Odds Ratio (OR)|4.57||||0.0021|TWO_SIDED|95.0|1.73|12.05||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||12.05|1.73|0.0021
72357901|NCT03192176|144229978|SUPERIORITY||Odds Ratio (OR)|3.06||||0.0171|TWO_SIDED|95.0|1.22|7.68||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||7.68|1.22|0.0171
72357902|NCT03192176|144229978|SUPERIORITY||Odds Ratio (OR)|1.86||||0.2224|TWO_SIDED|95.0|0.69|5.04||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||5.04|0.69|0.2224
72357903|NCT03192176|144229978|SUPERIORITY||Odds Ratio (OR)|1.74||||0.2716|TWO_SIDED|95.0|0.65|4.69||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||4.69|0.65|0.2716
72357904|NCT03192176|144229978|SUPERIORITY||Odds Ratio (OR)|4.49||||0.0112|TWO_SIDED|95.0|1.41|14.32||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||14.32|1.41|0.0112
72357905|NCT03192176|144229978|SUPERIORITY||Odds Ratio (OR)|3.08||||0.0461|TWO_SIDED|95.0|1.02|9.31||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||9.31|1.02|0.0461
72357906|NCT03192176|144229978|SUPERIORITY||Odds Ratio (OR)|1.63||||0.3463|TWO_SIDED|95.0|0.59|4.47||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||4.47|0.59|0.3463
72357907|NCT03192176|144229978|SUPERIORITY||Odds Ratio (OR)|3.05||||0.0419|TWO_SIDED|95.0|1.04|8.92||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||8.92|1.04|0.0419
72357908|NCT03192176|144229978|SUPERIORITY||Odds Ratio (OR)|1.68||||0.2977|TWO_SIDED|95.0|0.63|4.46||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||4.46|0.63|0.2977
72357909|NCT03192176|144229978|SUPERIORITY||Odds Ratio (OR)|1.87||||0.23|TWO_SIDED|95.0|0.67|5.21||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||5.21|0.67|0.2300
72357910|NCT03192176|144229978|SUPERIORITY||Odds Ratio (OR)|2.83||||0.0655|TWO_SIDED|95.0|0.94|8.58||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||8.58|0.94|0.0655
72429322|NCT01154036|144369659|SUPERIORITY_OR_OTHER_LEGACY||Difference in M-estimates|-7.4|||<|0.001|TWO_SIDED|95.0|-10.2|-4.5|||Multiple Imputation Robust Regression|M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values||||-4.5|-10.2|<0.001
72357911|NCT03192176|144229978|SUPERIORITY||Odds Ratio (OR)|3.79||||0.0245|TWO_SIDED|95.0|1.19|12.11||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||12.11|1.19|0.0245
72357912|NCT03192176|144229978|SUPERIORITY||Odds Ratio (OR)|5.62||||0.0129|TWO_SIDED|95.0|1.44|21.93||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||21.93|1.44|0.0129
72357913|NCT03192176|144229978|SUPERIORITY||Odds Ratio (OR)|2.37||||0.1259|TWO_SIDED|95.0|0.79|7.15||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||7.15|0.79|0.1259
72357914|NCT03192176|144229978|SUPERIORITY||Odds Ratio (OR)|2.4||||0.1015|TWO_SIDED|95.0|0.84|6.82||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||6.82|0.84|0.1015
72357915|NCT03192176|144229978|SUPERIORITY||Odds Ratio (OR)|4.48||||0.0167|TWO_SIDED|95.0|1.31|15.33||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||15.33|1.31|0.0167
72357916|NCT03192176|144229978|SUPERIORITY||Odds Ratio (OR)|1.4||||0.5232|TWO_SIDED|95.0|0.5|3.95||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||3.95|0.50|0.5232
72357917|NCT03192176|144229978|SUPERIORITY||Odds Ratio (OR)|2.0||||0.2055|TWO_SIDED|95.0|0.68|5.82||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||5.82|0.68|0.2055
72357918|NCT03192176|144229978|SUPERIORITY||Odds Ratio (OR)|3.0||||0.0658|TWO_SIDED|95.0|0.93|9.64||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||9.64|0.93|0.0658
72357919|NCT03192176|144229978|SUPERIORITY||Odds Ratio (OR)|7.34||||0.0136|TWO_SIDED|95.0|1.51|35.75||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||35.75|1.51|0.0136
72357920|NCT03192176|144229978|SUPERIORITY||Odds Ratio (OR)|1.71||||0.3238|TWO_SIDED|95.0|0.59|5.0||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||5.00|0.59|0.3238
72357921|NCT03192176|144229978|SUPERIORITY||Odds Ratio (OR)|5.86||||0.0118|TWO_SIDED|95.0|1.48|23.21||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||23.21|1.48|0.0118
72357922|NCT03192176|144229978|SUPERIORITY||Odds Ratio (OR)|5.29||||0.0163|TWO_SIDED|95.0|1.36|20.62||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||20.62|1.36|0.0163
72357923|NCT03192176|144229978|SUPERIORITY||Odds Ratio (OR)|1.32||||0.6363|TWO_SIDED|95.0|0.42|4.18||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||4.18|0.42|0.6363
72357924|NCT03192176|144229978|SUPERIORITY||Odds Ratio (OR)|3.68||||0.0722|TWO_SIDED|95.0|0.89|15.25||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||15.25|0.89|0.0722
72357925|NCT03192176|144229978|SUPERIORITY||Odds Ratio (OR)|2.35||||0.2019|TWO_SIDED|95.0|0.63|8.73||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||8.73|0.63|0.2019
72357926|NCT03192176|144229978|SUPERIORITY||Odds Ratio (OR)|10.15||||0.0337|TWO_SIDED|95.0|1.2|86.09||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||86.09|1.20|0.0337
72357927|NCT03192176|144229978|SUPERIORITY||Odds Ratio (OR)|2.25||||0.2207|TWO_SIDED|95.0|0.61|8.24||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||8.24|0.61|0.2207
72357928|NCT03192176|144229978|SUPERIORITY||Odds Ratio (OR)|3.5||||0.0849|TWO_SIDED|95.0|0.84|14.57||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||14.57|0.84|0.0849
72429323|NCT01154036|144369660|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-squares means|-2.1||||0.466|TWO_SIDED|95.0|-7.8|3.5|||Constrained Longitudinal Data Analysis|Geometric mean percent changes from baseline were calculated based on back-transformation via exponentiation of the model-based least square means||||3.5|-7.8|0.466
72357929|NCT03192176|144229978|SUPERIORITY||Odds Ratio (OR)|3.47||||0.0844|TWO_SIDED|95.0|0.84|14.24||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||14.24|0.84|0.0844
72357930|NCT03192176|144229978|SUPERIORITY||Odds Ratio (OR)|2.15||||0.2383|TWO_SIDED|95.0|0.6|7.65||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||7.65|0.60|0.2383
72357931|NCT03192176|144229978|SUPERIORITY||Odds Ratio (OR)|2.55||||0.1653|TWO_SIDED|95.0|0.68|9.58||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||9.58|0.68|0.1653
72357932|NCT03192176|144229978|SUPERIORITY||Odds Ratio (OR)|2.48||||0.1836|TWO_SIDED|95.0|0.65|9.48||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||9.48|0.65|0.1836
72357933|NCT03192176|144229978|SUPERIORITY||Odds Ratio (OR)|8.3||||0.0529|TWO_SIDED|95.0|0.97|70.8||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||70.80|0.97|0.0529
72357934|NCT03192176|144229978|SUPERIORITY||Odds Ratio (OR)|1.95||||0.3197|TWO_SIDED|95.0|0.52|7.27||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||7.27|0.52|0.3197
72357935|NCT03192176|144229978|SUPERIORITY||Odds Ratio (OR)|5.88||||0.0376|TWO_SIDED|95.0|1.11|31.25||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||31.25|1.11|0.0376
72357936|NCT03192176|144229978|SUPERIORITY||Odds Ratio (OR)|10.08||||0.0343|TWO_SIDED|95.0|1.19|85.64||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||85.64|1.19|0.0343
72357937|NCT03192176|144229978|SUPERIORITY||Odds Ratio (OR)|1.58||||0.4435|TWO_SIDED|95.0|0.49|5.09||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||5.09|0.49|0.4435
72357938|NCT03192176|144229978|SUPERIORITY||Odds Ratio (OR)|2.34||||0.1805|TWO_SIDED|95.0|0.67|8.13||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||8.13|0.67|0.1805
72357939|NCT03192176|144229978|SUPERIORITY||Odds Ratio (OR)|3.54||||0.0857|TWO_SIDED|95.0|0.84|14.95||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||14.95|0.84|0.0857
72357940|NCT03192176|144229978|SUPERIORITY||Odds Ratio (OR)|10.5||||0.0316|TWO_SIDED|95.0|1.23|89.63||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||89.63|1.23|0.0316
72357941|NCT03192176|144229978|SUPERIORITY||Odds Ratio (OR)|1.81||||0.3471|TWO_SIDED|95.0|0.52|6.27||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||6.27|0.52|0.3471
72357942|NCT03192176|144229978|SUPERIORITY||Odds Ratio (OR)|6.15||||0.0313|TWO_SIDED|95.0|1.18|32.09||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||32.09|1.18|0.0313
72357943|NCT03192176|144229978|SUPERIORITY||Odds Ratio (OR)|12.49||||0.0208|TWO_SIDED|95.0|1.47|106.3||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||106.3|1.47|0.0208
72357944|NCT03192176|144229978|SUPERIORITY||Odds Ratio (OR)|1.11||||0.8669|TWO_SIDED|95.0|0.31|3.97||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||3.97|0.31|0.8669
72357945|NCT03192176|144229978|SUPERIORITY||Odds Ratio (OR)|1.34||||0.6592|TWO_SIDED|95.0|0.37|4.89||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||4.89|0.37|0.6592
72357946|NCT03192176|144229978|SUPERIORITY||Odds Ratio (OR)|2.23||||0.2923|TWO_SIDED|95.0|0.5|9.98||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||9.98|0.50|0.2923
72429324|NCT01154036|144369660|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least-squares means|-4.9||||0.081|TWO_SIDED|95.0|-10.3|0.5|||Constrained Longitudinal Analysis|Geometric mean percent changes from baseline were calculated based on back-transformation via exponentiation of the model-based least square means||||0.5|-10.3|0.081
72357947|NCT03192176|144229978|SUPERIORITY||Odds Ratio (OR)|5.78||||0.1145|TWO_SIDED|95.0|0.65|51.04||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||51.04|0.65|0.1145
72357948|NCT03192176|144229978|SUPERIORITY||Odds Ratio (OR)|1.77||||0.447|TWO_SIDED|95.0|0.4|7.78||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||7.78|0.40|0.4470
72357949|NCT03192176|144229978|SUPERIORITY||Odds Ratio (OR)|7.31||||0.0753|TWO_SIDED|95.0|0.82|65.41||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||65.41|0.82|0.0753
72357950|NCT03192176|144229978|SUPERIORITY||Odds Ratio (OR)|6.85||||0.0829|TWO_SIDED|95.0|0.78|60.24||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||60.24|0.78|0.0829
72357951|NCT03192176|144229978|SUPERIORITY||Odds Ratio (OR)|1.0||||0.9978|TWO_SIDED|95.0|0.28|3.59||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||3.59|0.28|0.9978
72357952|NCT03192176|144229978|SUPERIORITY||Odds Ratio (OR)|1.68||||0.4571|TWO_SIDED|95.0|0.43|6.65||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||6.65|0.43|0.4571
72357953|NCT03192176|144229978|SUPERIORITY||Odds Ratio (OR)|1.99||||0.3681|TWO_SIDED|95.0|0.44|8.94||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||8.94|0.44|0.3681
72357954|NCT03192176|144229978|SUPERIORITY||Odds Ratio (OR)|6.12||||0.1038|TWO_SIDED|95.0|0.69|54.38||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||54.38|0.69|0.1038
72357955|NCT03192176|144229978|SUPERIORITY||Odds Ratio (OR)|1.74||||0.4639|TWO_SIDED|95.0|0.39|7.72||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||7.72|0.39|0.4639
72357956|NCT03192176|144229978|SUPERIORITY||Odds Ratio (OR)|7.15||||0.077|TWO_SIDED|95.0|0.81|63.27||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||63.27|0.81|0.0770
72357957|NCT03192176|144229978|SUPERIORITY||Odds Ratio (OR)|1.01||||0.9838|TWO_SIDED|95.0|0.26|4.01||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||4.01|0.26|0.9838
72357958|NCT03192176|144229978|SUPERIORITY||Odds Ratio (OR)|0.77||||0.6995|TWO_SIDED|95.0|0.21|2.86||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||2.86|0.21|0.6995
72357959|NCT03192176|144229978|SUPERIORITY||Odds Ratio (OR)|1.12||||0.8808|TWO_SIDED|95.0|0.26|4.71||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||4.71|0.26|0.8808
72357960|NCT03192176|144229978|SUPERIORITY||Odds Ratio (OR)|4.94||||0.157|TWO_SIDED|95.0|0.54|45.13||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||45.13|0.54|0.1570
72357961|NCT03192176|144229978|SUPERIORITY||Odds Ratio (OR)|2.19||||0.3742|TWO_SIDED|95.0|0.39|12.26||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||12.26|0.39|0.3742
72357962|NCT03192176|144229978|SUPERIORITY||Odds Ratio (OR)|5.24||||0.1436|TWO_SIDED|95.0|0.57|48.26||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||48.26|0.57|0.1436
72357963|NCT03192176|144229978|SUPERIORITY||Odds Ratio (OR)|5.57||||0.1277|TWO_SIDED|95.0|0.61|50.77||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||50.77|0.61|0.1277
72357964|NCT03192176|144229978|SUPERIORITY||Odds Ratio (OR)|0.75||||0.6689|TWO_SIDED|95.0|0.2|2.81||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||2.81|0.20|0.6689
72357965|NCT03192176|144229978|SUPERIORITY||Odds Ratio (OR)|1.2||||0.8019|TWO_SIDED|95.0|0.29|4.95||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||4.95|0.29|0.8019
72357966|NCT03192176|144229978|SUPERIORITY||Odds Ratio (OR)|0.96||||0.9591|TWO_SIDED|95.0|0.23|4.05||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||4.05|0.23|0.9591
72357967|NCT03192176|144229978|SUPERIORITY||Odds Ratio (OR)|2.33||||0.3364|TWO_SIDED|95.0|0.42|13.06||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||13.06|0.42|0.3364
72357968|NCT03192176|144229978|SUPERIORITY||Odds Ratio (OR)|2.2||||0.3698|TWO_SIDED|95.0|0.39|12.32||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||12.32|0.39|0.3698
72357969|NCT03192176|144229978|SUPERIORITY||Odds Ratio (OR)|4.92||||0.1587|TWO_SIDED|95.0|0.54|45.01||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||45.01|0.54|0.1587
72357970|NCT03192176|144229978|SUPERIORITY||Odds Ratio (OR)|5.5||||0.13|TWO_SIDED|95.0|0.61|50.06||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||50.06|0.61|0.1300
72357971|NCT03192176|144229978|SUPERIORITY||Odds Ratio (OR)|1.81||||0.4152|TWO_SIDED|95.0|0.43|7.53||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||7.53|0.43|0.4152
72357972|NCT03192176|144229978|SUPERIORITY||Odds Ratio (OR)|0.97||||0.9645|TWO_SIDED|95.0|0.27|3.5||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||3.50|0.27|0.9645
72357973|NCT03192176|144229978|SUPERIORITY||Odds Ratio (OR)|1.95||||0.3884|TWO_SIDED|95.0|0.43|8.96||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||8.96|0.43|0.3884
72357974|NCT03192176|144229978|SUPERIORITY||Odds Ratio (OR)|2.62||||0.267|TWO_SIDED|95.0|0.48|14.41||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||14.41|0.48|0.2670
72357975|NCT03192176|144229978|SUPERIORITY||Odds Ratio (OR)|6.91||||0.0861|TWO_SIDED|95.0|0.76|62.9||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||62.90|0.76|0.0861
72357976|NCT03192176|144229978|SUPERIORITY||Odds Ratio (OR)|7.21||||0.0774|TWO_SIDED|95.0|0.8|64.66||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||64.66|0.80|0.0774
72357977|NCT03192176|144229978|SUPERIORITY||Odds Ratio (OR)|4.73||||0.0389|TWO_SIDED|95.0|1.08|20.65||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||20.65|1.08|0.0389
72357978|NCT03192176|144229978|SUPERIORITY||Odds Ratio (OR)|1.81||||0.3695|TWO_SIDED|95.0|0.5|6.57||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||6.57|0.50|0.3695
72357979|NCT03192176|144229978|SUPERIORITY||Odds Ratio (OR)|1.95||||0.3501|TWO_SIDED|95.0|0.48|7.89||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||7.89|0.48|0.3501
72357980|NCT03192176|144229978|SUPERIORITY||Odds Ratio (OR)|2.49||||0.2021|TWO_SIDED|95.0|0.61|10.14||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||10.14|0.61|0.2021
72357981|NCT03192176|144229978|SUPERIORITY||Odds Ratio (OR)|1.42||||0.6201|TWO_SIDED|95.0|0.36|5.62||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||5.62|0.36|0.6201
72357982|NCT03192176|144229978|SUPERIORITY||Odds Ratio (OR)|13.71||||0.0235|TWO_SIDED|95.0|1.42|132.0||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||132.0|1.42|0.0235
72357983|NCT03192176|144229978|SUPERIORITY||Odds Ratio (OR)|3.43||||0.0929|TWO_SIDED|95.0|0.81|14.48||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||14.48|0.81|0.0929
72357984|NCT03192176|144229978|SUPERIORITY||Odds Ratio (OR)|0.99||||0.982|TWO_SIDED|95.0|0.29|3.33||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||3.33|0.29|0.9820
72357985|NCT03192176|144229978|SUPERIORITY||Odds Ratio (OR)|1.55||||0.4956|TWO_SIDED|95.0|0.44|5.41||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||5.41|0.44|0.4956
72357986|NCT03192176|144229978|SUPERIORITY||Odds Ratio (OR)|0.7||||0.5708|TWO_SIDED|95.0|0.2|2.44||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||2.44|0.20|0.5708
72357987|NCT03192176|144229978|SUPERIORITY||Odds Ratio (OR)|2.55||||0.1985|TWO_SIDED|95.0|0.61|10.61||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||10.61|0.61|0.1985
72357988|NCT03192176|144229978|SUPERIORITY||Odds Ratio (OR)|1.15||||0.8368|TWO_SIDED|95.0|0.31|4.32||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||4.32|0.31|0.8368
72357989|NCT03192176|144229978|SUPERIORITY||Odds Ratio (OR)|3.18||||0.1397|TWO_SIDED|95.0|0.68|14.76||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||14.76|0.68|0.1397
72357990|NCT03192176|144229978|SUPERIORITY||Odds Ratio (OR)|1.88||||0.0366|TWO_SIDED|95.0|0.52|6.85||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||6.85|0.52|0.0366
72357991|NCT03192176|144229978|SUPERIORITY||Odds Ratio (OR)|0.84||||0.7968|TWO_SIDED|95.0|0.23|3.05||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||3.05|0.23|0.7968
72357992|NCT03192176|144229978|SUPERIORITY||Odds Ratio (OR)|1.08||||0.9074|TWO_SIDED|95.0|0.3|3.81||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||3.81|0.30|0.9074
72357993|NCT03192176|144229978|SUPERIORITY||Odds Ratio (OR)|0.41||||0.1987|TWO_SIDED|95.0|0.1|1.6||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||1.60|0.10|0.1987
72357994|NCT03192176|144229978|SUPERIORITY||Odds Ratio (OR)|2.58||||0.204|TWO_SIDED|95.0|0.6|11.18||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||11.18|0.60|0.2040
72357995|NCT03192176|144229978|SUPERIORITY||Odds Ratio (OR)|0.51||||0.3318|TWO_SIDED|95.0|0.13|1.99||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||1.99|0.13|0.3318
72357996|NCT03192176|144229978|SUPERIORITY||Odds Ratio (OR)|1.26||||0.7437|TWO_SIDED|95.0|0.31|5.1||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||5.10|0.31|0.7437
72357997|NCT03192176|144229978|SUPERIORITY||Odds Ratio (OR)|1.3||||0.6848|TWO_SIDED|95.0|0.36|4.71||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||4.71|0.36|0.6848
72357998|NCT03192176|144229979|SUPERIORITY||Odds Ratio (OR)|2.12||||0.1114|TWO_SIDED|95.0|0.84|5.32||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||5.32|0.84|0.1114
72357999|NCT03192176|144229979|SUPERIORITY||Odds Ratio (OR)|4.69||||0.0013|TWO_SIDED|95.0|1.83|12.04||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||12.04|1.83|0.0013
72358000|NCT03192176|144229979|SUPERIORITY||Odds Ratio (OR)|7.01|||<|0.0001|TWO_SIDED|95.0|2.65|18.54||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||18.54|2.65|<0.0001
72358001|NCT03192176|144229979|SUPERIORITY||Odds Ratio (OR)|4.96||||0.001|TWO_SIDED|95.0|1.91|12.89||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||12.89|1.91|0.0010
72429325|NCT01154036|144369661|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least-squares Means|-2.8||||0.466|TWO_SIDED|95.0|-10.2|4.7|||Constrained Longitudinal Data Analysis|Geometric mean percent changes from baseline were calculated based on back-transformation via exponentiation of the model-based least square means||||4.7|-10.2|0.466
72358002|NCT03192176|144229979|SUPERIORITY||Odds Ratio (OR)|1.25||||0.6384|TWO_SIDED|95.0|0.49|3.22||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||3.22|0.49|0.6384
72358003|NCT03192176|144229979|SUPERIORITY||Odds Ratio (OR)|5.77||||0.0003|TWO_SIDED|95.0|2.23|14.93||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||14.93|2.23|0.0003
72358004|NCT03192176|144229979|SUPERIORITY||Odds Ratio (OR)|4.15||||0.0025|TWO_SIDED|95.0|1.65|10.45||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||10.45|1.65|0.0025
72358005|NCT03192176|144229979|SUPERIORITY||Odds Ratio (OR)|2.82||||0.0279|TWO_SIDED|95.0|1.12|7.12||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||7.12|1.12|0.0279
72358006|NCT03192176|144229979|SUPERIORITY||Odds Ratio (OR)|3.36||||0.0114|TWO_SIDED|95.0|1.31|8.61||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||8.61|1.31|0.0114
72358007|NCT03192176|144229979|SUPERIORITY||Odds Ratio (OR)|7.55||||0.0001|TWO_SIDED|95.0|2.66|21.45||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||21.45|2.66|0.0001
72358008|NCT03192176|144229979|SUPERIORITY||Odds Ratio (OR)|6.41||||0.0005|TWO_SIDED|95.0|2.25|18.26||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||18.26|2.25|0.0005
72358009|NCT03192176|144229979|SUPERIORITY||Odds Ratio (OR)|2.37||||0.0695|TWO_SIDED|95.0|0.93|6.02||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||6.02|0.93|0.0695
72358010|NCT03192176|144229979|SUPERIORITY||Odds Ratio (OR)|4.83||||0.0015|TWO_SIDED|95.0|1.83|12.77||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||12.77|1.83|0.0015
72358011|NCT03192176|144229979|SUPERIORITY||Odds Ratio (OR)|3.28||||0.012|TWO_SIDED|95.0|1.3|8.28||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||8.28|1.30|0.0120
72358012|NCT03192176|144229979|SUPERIORITY||Odds Ratio (OR)|2.49||||0.662|TWO_SIDED|95.0|0.94|6.57||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||6.57|0.94|0.662
72358013|NCT03192176|144229979|SUPERIORITY||Odds Ratio (OR)|2.22||||0.1019|TWO_SIDED|95.0|0.85|5.8||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||5.80|0.85|0.1019
72358014|NCT03192176|144229979|SUPERIORITY||Odds Ratio (OR)|5.44||||0.0023|TWO_SIDED|95.0|1.83|16.18||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||16.18|1.83|0.0023
72358015|NCT03192176|144229979|SUPERIORITY||Odds Ratio (OR)|7.33||||0.0015|TWO_SIDED|95.0|2.15|25.02||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||25.02|2.15|0.0015
72358016|NCT03192176|144229979|SUPERIORITY||Odds Ratio (OR)|1.78||||0.238|TWO_SIDED|95.0|0.68|4.66||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||4.66|0.68|0.2380
72358017|NCT03192176|144229979|SUPERIORITY||Odds Ratio (OR)|3.61||||0.012|TWO_SIDED|95.0|1.33|9.81||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||9.81|1.33|0.0120
72358018|NCT03192176|144229979|SUPERIORITY||Odds Ratio (OR)|2.25||||0.091|TWO_SIDED|95.0|0.88|5.77||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||5.77|0.88|0.0910
72358019|NCT03192176|144229979|SUPERIORITY||Odds Ratio (OR)|1.93||||0.1926|TWO_SIDED|95.0|0.72|5.18||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||5.18|0.72|0.1926
72358020|NCT03192176|144229979|SUPERIORITY||Odds Ratio (OR)|2.29||||0.1017|TWO_SIDED|95.0|0.85|6.15||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||6.15|0.85|0.1017
72358021|NCT03192176|144229979|SUPERIORITY||Odds Ratio (OR)|3.85||||0.0153|TWO_SIDED|95.0|1.29|11.45||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||11.45|1.29|0.0153
72358022|NCT03192176|144229979|SUPERIORITY||Odds Ratio (OR)|7.52||||0.0034|TWO_SIDED|95.0|1.95|28.98||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||28.98|1.95|0.0034
72358023|NCT03192176|144229979|SUPERIORITY||Odds Ratio (OR)|1.44||||0.4539|TWO_SIDED|95.0|0.55|3.76||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||3.76|0.55|0.4539
72358024|NCT03192176|144229979|SUPERIORITY||Odds Ratio (OR)|3.03||||0.0327|TWO_SIDED|95.0|1.1|8.4||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||8.40|1.10|0.0327
72358025|NCT03192176|144229979|SUPERIORITY||Odds Ratio (OR)|2.67||||0.0555|TWO_SIDED|95.0|0.98|7.3||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||7.30|0.98|0.0555
72358026|NCT03192176|144229979|SUPERIORITY||Odds Ratio (OR)|1.64||||0.3505|TWO_SIDED|95.0|0.58|4.67||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||4.67|0.58|0.3505
72358027|NCT03192176|144229979|SUPERIORITY||Odds Ratio (OR)|3.92||||0.0265|TWO_SIDED|95.0|1.17|13.11||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||13.11|1.17|0.0265
72358028|NCT03192176|144229979|SUPERIORITY||Odds Ratio (OR)|4.77||||0.0174|TWO_SIDED|95.0|1.32|17.32||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||17.32|1.32|0.0174
72358029|NCT03192176|144229979|SUPERIORITY||Odds Ratio (OR)|8.95||||0.0075|TWO_SIDED|95.0|1.8|44.61||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||44.61|1.80|0.0075
72358030|NCT03192176|144229979|SUPERIORITY||Odds Ratio (OR)|2.46||||0.1228|TWO_SIDED|95.0|0.78|7.68||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||7.68|0.78|0.1228
72358031|NCT03192176|144229979|SUPERIORITY||Odds Ratio (OR)|3.28||||0.0431|TWO_SIDED|95.0|1.04|10.38||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||10.38|1.04|0.0431
72358032|NCT03192176|144229979|SUPERIORITY||Odds Ratio (OR)|2.7||||0.0851|TWO_SIDED|95.0|0.87|8.35||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||8.35|0.87|0.0851
72358033|NCT03192176|144229979|SUPERIORITY||Odds Ratio (OR)|1.45||||0.4726|TWO_SIDED|95.0|0.53|3.99||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||3.99|0.53|0.4726
72358034|NCT03192176|144229979|SUPERIORITY||Odds Ratio (OR)|2.29||||0.1289|TWO_SIDED|95.0|0.79|6.67||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||6.67|0.79|0.1289
72358035|NCT03192176|144229979|SUPERIORITY||Odds Ratio (OR)|3.39||||0.04|TWO_SIDED|95.0|1.06|10.84||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||10.84|1.06|0.0400
72358036|NCT03192176|144229979|SUPERIORITY||Odds Ratio (OR)|8.22||||0.0097|TWO_SIDED|95.0|1.67|40.55||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||40.55|1.67|0.0097
72358037|NCT03192176|144229979|SUPERIORITY||Odds Ratio (OR)|1.97||||0.226|TWO_SIDED|95.0|0.66|5.94||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||5.94|0.66|0.2260
72429326|NCT01154036|144369661|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least-squarres Means|-7.1||||0.011|TWO_SIDED|95.0|-12.6|-1.6|||Constrained Longitudinal Data Analysis|Geometric mean percent changes from baseline were calculated based on back-transformation via exponentiation of the model-based least square means||||-1.6|-12.6|0.011
72358038|NCT03192176|144229979|SUPERIORITY||Odds Ratio (OR)|8.63||||0.0031|TWO_SIDED|95.0|2.07|35.96||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||35.96|2.07|0.0031
72358039|NCT03192176|144229979|SUPERIORITY||Odds Ratio (OR)|10.16||||0.0043|TWO_SIDED|95.0|2.07|49.9||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||49.90|2.07|0.0043
72358040|NCT03192176|144229979|SUPERIORITY||Odds Ratio (OR)|1.38||||0.5571|TWO_SIDED|95.0|0.47|4.04||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||4.04|0.47|0.5571
72358041|NCT03192176|144229979|SUPERIORITY||Odds Ratio (OR)|2.13||||0.1911|TWO_SIDED|95.0|0.69|6.59||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||6.59|0.69|0.1911
72358042|NCT03192176|144229979|SUPERIORITY||Odds Ratio (OR)|2.74||||0.1101|TWO_SIDED|95.0|0.8|9.41||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||9.41|0.80|0.1101
72358043|NCT03192176|144229979|SUPERIORITY||Odds Ratio (OR)|6.86||||0.0199|TWO_SIDED|95.0|1.36|34.74||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||34.74|1.36|0.0199
72358044|NCT03192176|144229979|SUPERIORITY||Odds Ratio (OR)|1.96||||0.26|TWO_SIDED|95.0|0.61|6.33||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||6.33|0.61|0.2600
72358045|NCT03192176|144229979|SUPERIORITY||Odds Ratio (OR)|8.93||||0.009|TWO_SIDED|95.0|1.73|46.19||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||46.19|1.73|0.0090
72358046|NCT03192176|144229979|SUPERIORITY||Odds Ratio (OR)|17.22||||0.0089|TWO_SIDED|95.0|2.04|145.2||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||145.2|2.04|0.0089
72358047|NCT03192176|144229979|SUPERIORITY||Odds Ratio (OR)|1.07||||0.8966|TWO_SIDED|95.0|0.36|3.19||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||3.19|0.36|0.8966
72358048|NCT03192176|144229979|SUPERIORITY||Odds Ratio (OR)|1.47||||0.5031|TWO_SIDED|95.0|0.48|4.51||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||4.51|0.48|0.5031
72358049|NCT03192176|144229979|SUPERIORITY||Odds Ratio (OR)|2.03||||0.2603|TWO_SIDED|95.0|0.59|6.92||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||6.92|0.59|0.2603
72358050|NCT03192176|144229979|SUPERIORITY||Odds Ratio (OR)|2.16||||0.2447|TWO_SIDED|95.0|0.59|7.88||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||7.88|0.59|0.2447
72358051|NCT03192176|144229979|SUPERIORITY||Odds Ratio (OR)|1.64||||0.4239|TWO_SIDED|95.0|0.49|5.55||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||5.55|0.49|0.4239
72358052|NCT03192176|144229979|SUPERIORITY||Odds Ratio (OR)|11.72||||0.024|TWO_SIDED|95.0|1.38|99.35||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||99.35|1.38|0.0240
72358053|NCT03192176|144229979|SUPERIORITY||Odds Ratio (OR)|2.6||||0.1457|TWO_SIDED|95.0|0.72|9.41||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||9.41|0.72|0.1457
72358054|NCT03192176|144229979|SUPERIORITY||Odds Ratio (OR)|1.08||||0.9|TWO_SIDED|95.0|0.34|3.38||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||3.38|0.34|0.9000
72358055|NCT03192176|144229979|SUPERIORITY||Odds Ratio (OR)|1.19||||0.7644|TWO_SIDED|95.0|0.39|3.64||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||3.64|0.39|0.7644
72429327|NCT01154036|144369662|SUPERIORITY_OR_OTHER_LEGACY||Difference in M--estimates|1.7||||0.133|TWO_SIDED|95.0|-0.5|4.0|||Multiple Imputation Robust Regression|M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values||||4.0|-0.5|0.133
72358056|NCT03192176|144229979|SUPERIORITY||Odds Ratio (OR)|2.29||||0.2245|TWO_SIDED|95.0|0.6|8.67||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||8.67|0.60|0.2245
72358057|NCT03192176|144229979|SUPERIORITY||Odds Ratio (OR)|5.28||||0.0475|TWO_SIDED|95.0|1.02|27.4||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||27.40|1.02|0.0475
72358058|NCT03192176|144229979|SUPERIORITY||Odds Ratio (OR)|2.15||||0.2569|TWO_SIDED|95.0|0.57|8.07||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||8.07|0.57|0.2569
72358059|NCT03192176|144229979|SUPERIORITY||Odds Ratio (OR)|9.32||||0.0412|TWO_SIDED|95.0|1.09|79.44||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||79.44|1.09|0.0412
72358060|NCT03192176|144229979|SUPERIORITY||Odds Ratio (OR)|2.84||||0.1201|TWO_SIDED|95.0|0.76|10.61||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||10.61|0.76|0.1201
72358061|NCT03192176|144229979|SUPERIORITY||Odds Ratio (OR)|1.67||||0.3814|TWO_SIDED|95.0|0.53|5.23||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||5.23|0.53|0.3814
72358062|NCT03192176|144229979|SUPERIORITY||Odds Ratio (OR)|1.11||||0.8549|TWO_SIDED|95.0|0.38|3.23||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||3.23|0.38|0.8549
72358063|NCT03192176|144229979|SUPERIORITY||Odds Ratio (OR)|2.77||||0.1274|TWO_SIDED|95.0|0.75|10.24||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||10.24|0.75|0.1274
72358064|NCT03192176|144229979|SUPERIORITY||Odds Ratio (OR)|3.67||||0.0703|TWO_SIDED|95.0|0.9|15.01||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||15.01|0.90|0.0703
72358065|NCT03192176|144229979|SUPERIORITY||Odds Ratio (OR)|2.41||||0.1821|TWO_SIDED|95.0|0.66|8.76||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||8.76|0.66|0.1821
72358066|NCT03192176|144229979|SUPERIORITY||Odds Ratio (OR)|12.96||||0.0187|TWO_SIDED|95.0|1.53|109.5||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||109.5|1.53|0.0187
72358067|NCT03192176|144229979|SUPERIORITY||Odds Ratio (OR)|4.18||||0.0458|TWO_SIDED|95.0|1.03|17.0||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||17.00|1.03|0.0458
72358068|NCT03192176|144229979|SUPERIORITY||Odds Ratio (OR)|1.27||||0.6806|TWO_SIDED|95.0|0.41|3.89||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||3.89|0.41|0.6806
72358069|NCT03192176|144229979|SUPERIORITY||Odds Ratio (OR)|1.15||||0.809|TWO_SIDED|95.0|0.38|3.45||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||3.45|0.38|0.8090
72358070|NCT03192176|144229979|SUPERIORITY||Odds Ratio (OR)|2.22||||0.2352|TWO_SIDED|95.0|0.6|8.26||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||8.26|0.60|0.2352
72358071|NCT03192176|144229979|SUPERIORITY||Odds Ratio (OR)|3.04||||0.1231|TWO_SIDED|95.0|0.74|12.5||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||12.50|0.74|0.1231
72358072|NCT03192176|144229979|SUPERIORITY||Odds Ratio (OR)|2.86||||0.1445|TWO_SIDED|95.0|0.7|11.76||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||11.76|0.70|0.1445
72358073|NCT03192176|144229979|SUPERIORITY||Odds Ratio (OR)|12.03||||0.023|TWO_SIDED|95.0|1.41|102.7||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||102.7|1.41|0.0230
72429328|NCT01154036|144369662|SUPERIORITY_OR_OTHER_LEGACY||Difference in M-estimates|-0.6||||0.61|TWO_SIDED|95.0|-2.7|1.6|||Multiple Imputation Robust Regression|M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values||||1.6|-2.7|0.610
72358074|NCT03192176|144229979|SUPERIORITY||Odds Ratio (OR)|3.51||||0.0801|TWO_SIDED|95.0|0.86|14.36||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||14.36|0.86|0.0801
72358075|NCT03192176|144229979|SUPERIORITY||Odds Ratio (OR)|1.63||||0.4152|TWO_SIDED|95.0|0.5|5.32||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||5.32|0.50|0.4152
72358076|NCT03192176|144229979|SUPERIORITY||Odds Ratio (OR)|1.7||||0.3845|TWO_SIDED|95.0|0.51|5.65||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||5.65|0.51|0.3845
72358077|NCT03192176|144229979|SUPERIORITY||Odds Ratio (OR)|2.46||||0.1864|TWO_SIDED|95.0|0.65|9.39||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||9.39|0.65|0.1864
72358078|NCT03192176|144229979|SUPERIORITY||Odds Ratio (OR)|3.06||||0.01268|TWO_SIDED|95.0|0.73|12.86||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||12.86|0.73|0.01268
72358079|NCT03192176|144229979|SUPERIORITY||Odds Ratio (OR)|2.8||||0.16|TWO_SIDED|95.0|0.67|11.76||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||11.76|0.67|0.1600
72358080|NCT03192176|144229979|SUPERIORITY||Odds Ratio (OR)|6.13||||0.0317|TWO_SIDED|95.0|1.17|32.11||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||32.11|1.17|0.0317
72358081|NCT03192176|144229979|SUPERIORITY||Odds Ratio (OR)|3.73||||0.0709|TWO_SIDED|95.0|0.89|15.53||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||15.53|0.89|0.0709
72358082|NCT03192176|144229979|SUPERIORITY||Odds Ratio (OR)|1.6||||0.4533|TWO_SIDED|95.0|0.47|5.41||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||5.41|0.47|0.4533
72358083|NCT03192176|144229979|SUPERIORITY||Odds Ratio (OR)|0.8||||0.7053|TWO_SIDED|95.0|0.24|2.6||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||2.60|0.24|0.7053
72358084|NCT03192176|144229979|SUPERIORITY||Odds Ratio (OR)|1.84||||0.3677|TWO_SIDED|95.0|0.49|6.99||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||6.99|0.49|0.3677
72358085|NCT03192176|144229979|SUPERIORITY||Odds Ratio (OR)|1.24||||0.735|TWO_SIDED|95.0|0.35|4.4||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||4.40|0.35|0.7350
72358086|NCT03192176|144229979|SUPERIORITY||Odds Ratio (OR)|1.37||||0.6443|TWO_SIDED|95.0|0.36|5.15||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||5.15|0.36|0.6443
72358087|NCT03192176|144229979|SUPERIORITY||Odds Ratio (OR)|1.58||||0.4865|TWO_SIDED|95.0|0.43|5.76||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||5.76|0.43|0.4865
72358088|NCT03192176|144229979|SUPERIORITY||Odds Ratio (OR)|2.52||||0.1628|TWO_SIDED|95.0|0.69|9.27||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||9.27|0.69|0.1628
72358089|NCT03192176|144229979|SUPERIORITY||Odds Ratio (OR)|0.79||||0.6935|TWO_SIDED|95.0|0.24|2.57||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||2.57|0.24|0.6935
72358090|NCT03192176|144229979|SUPERIORITY||Odds Ratio (OR)|1.02||||0.9753|TWO_SIDED|95.0|0.32|3.28||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||3.28|0.32|0.9753
72358091|NCT03192176|144229979|SUPERIORITY||Odds Ratio (OR)|0.81||||0.7407|TWO_SIDED|95.0|0.23|2.81||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||2.81|0.23|0.7407
72429329|NCT01154036|144369663|SUPERIORITY_OR_OTHER_LEGACY||Difference in M-estimates|-1.0||||0.52|TWO_SIDED|95.0|-4.2|2.1|||Multiple Imputation Robust Regression|M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values||||2.1|-4.2|0.520
72358092|NCT03192176|144229979|SUPERIORITY||Odds Ratio (OR)|1.55||||0.4929|TWO_SIDED|95.0|0.44|5.49||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||5.49|0.44|0.4929
72358093|NCT03192176|144229979|SUPERIORITY||Odds Ratio (OR)|0.88||||0.8496|TWO_SIDED|95.0|0.25|3.15||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||3.15|0.25|0.8496
72358094|NCT03192176|144229979|SUPERIORITY||Odds Ratio (OR)|1.92||||0.3248|TWO_SIDED|95.0|0.52|7.05||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||7.05|0.52|0.3248
72358095|NCT03192176|144229979|SUPERIORITY||Odds Ratio (OR)|2.03||||0.2589|TWO_SIDED|95.0|0.59|6.92||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||6.92|0.59|0.2589
72358096|NCT03192176|144229979|SUPERIORITY||Odds Ratio (OR)|0.54||||0.3318|TWO_SIDED|95.0|0.16|1.87||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||1.87|0.16|0.3318
72358097|NCT03192176|144229979|SUPERIORITY||Odds Ratio (OR)|0.89||||0.8536|TWO_SIDED|95.0|0.26|3.01||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||3.01|0.26|0.8536
72358098|NCT03192176|144229979|SUPERIORITY||Odds Ratio (OR)|0.48||||0.2817|TWO_SIDED|95.0|0.12|1.84||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||1.84|0.12|0.2817
72358099|NCT03192176|144229979|SUPERIORITY||Odds Ratio (OR)|0.59||||0.4091|TWO_SIDED|95.0|0.17|2.07||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||2.07|0.17|0.4091
72358100|NCT03192176|144229979|SUPERIORITY||Odds Ratio (OR)|0.5||||0.3147|TWO_SIDED|95.0|0.13|1.93||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||1.93|0.13|0.3147
72358101|NCT03192176|144229979|SUPERIORITY||Odds Ratio (OR)|0.89||||0.8547|TWO_SIDED|95.0|0.24|3.24||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||3.24|0.24|0.8547
72358102|NCT03192176|144229979|SUPERIORITY||Odds Ratio (OR)|0.66||||0.5023|TWO_SIDED|95.0|0.2|2.19||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||2.19|0.20|0.5023
72358103|NCT03192176|144229980|SUPERIORITY||Odds Ratio (OR)|3.99||||0.0093|TWO_SIDED|95.0|1.41|11.35||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||11.35|1.41|0.0093
72358104|NCT03192176|144229980|SUPERIORITY||Odds Ratio (OR)|4.66||||0.0035|TWO_SIDED|95.0|1.66|13.09||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||13.09|1.66|0.0035
72358105|NCT03192176|144229980|SUPERIORITY||Odds Ratio (OR)|8.48|||<|0.0001|TWO_SIDED|95.0|3.01|23.9||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||23.90|3.01|<0.0001
72358106|NCT03192176|144229980|SUPERIORITY||Odds Ratio (OR)|7.57||||0.0002|TWO_SIDED|95.0|2.65|21.59||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||21.59|2.65|0.0002
72358107|NCT03192176|144229980|SUPERIORITY||Odds Ratio (OR)|2.13||||0.1664|TWO_SIDED|95.0|0.73|6.22||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||6.22|0.73|0.1664
72358108|NCT03192176|144229980|SUPERIORITY||Odds Ratio (OR)|5.39||||0.0012|TWO_SIDED|95.0|1.94|14.96||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||14.96|1.94|0.0012
72358109|NCT03192176|144229980|SUPERIORITY||Odds Ratio (OR)|9.85|||<|0.0001|TWO_SIDED|95.0|3.49|27.86||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||27.86|3.49|<0.0001
72429330|NCT01154036|144369663|SUPERIORITY_OR_OTHER_LEGACY||Difference in M-estimates|-0.7||||0.567|TWO_SIDED|95.0|-3.1|1.7|||Multiple Imputation Robust Regression|M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values||||1.7|-3.1|0.567
72358110|NCT03192176|144229980|SUPERIORITY||Odds Ratio (OR)|2.73||||0.0334|TWO_SIDED|95.0|1.08|6.89||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||6.89|1.08|0.0334
72358111|NCT03192176|144229980|SUPERIORITY||Odds Ratio (OR)|4.12||||0.0034|TWO_SIDED|95.0|1.6|10.62||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||10.62|1.60|0.0034
72358112|NCT03192176|144229980|SUPERIORITY||Odds Ratio (OR)|6.55||||0.0002|TWO_SIDED|95.0|2.45|17.47||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||17.47|2.45|0.0002
72358113|NCT03192176|144229980|SUPERIORITY||Odds Ratio (OR)|4.9||||0.0014|TWO_SIDED|95.0|1.85|12.98||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||12.98|1.85|0.0014
72358114|NCT03192176|144229980|SUPERIORITY||Odds Ratio (OR)|2.26||||0.0872|TWO_SIDED|95.0|0.89|5.74||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||5.74|0.89|0.0872
72358115|NCT03192176|144229980|SUPERIORITY||Odds Ratio (OR)|3.19||||0.0131|TWO_SIDED|95.0|1.28|7.98||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||7.98|1.28|0.0131
72358116|NCT03192176|144229980|SUPERIORITY||Odds Ratio (OR)|2.6||||0.0386|TWO_SIDED|95.0|1.05|6.43||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||6.43|1.05|0.0386
72358117|NCT03192176|144229980|SUPERIORITY||Odds Ratio (OR)|3.11||||0.0191|TWO_SIDED|95.0|1.2|8.05||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||8.05|1.20|0.0191
72358118|NCT03192176|144229980|SUPERIORITY||Odds Ratio (OR)|2.84||||0.0291|TWO_SIDED|95.0|1.11|7.26||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||7.26|1.11|0.0291
72358119|NCT03192176|144229980|SUPERIORITY||Odds Ratio (OR)|6.09||||0.0004|TWO_SIDED|95.0|2.23|16.58||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||16.58|2.23|0.0004
72358120|NCT03192176|144229980|SUPERIORITY||Odds Ratio (OR)|7.24||||0.0003|TWO_SIDED|95.0|2.49|21.02||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||21.02|2.49|0.0003
72358121|NCT03192176|144229980|SUPERIORITY||Odds Ratio (OR)|2.22||||0.0992|TWO_SIDED|95.0|0.86|5.72||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||5.72|0.86|0.0992
72358122|NCT03192176|144229980|SUPERIORITY||Odds Ratio (OR)|5.66||||0.0006|TWO_SIDED|95.0|2.11|15.16||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||15.16|2.11|0.0006
72358123|NCT03192176|144229980|SUPERIORITY||Odds Ratio (OR)|3.74||||0.006|TWO_SIDED|95.0|1.46|9.59||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||9.59|1.46|0.0060
72358124|NCT03192176|144229980|SUPERIORITY||Odds Ratio (OR)|2.01||||0.1472|TWO_SIDED|95.0|0.78|5.14||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||5.14|0.78|0.1472
72358125|NCT03192176|144229980|SUPERIORITY||Odds Ratio (OR)|2.05||||0.1284|TWO_SIDED|95.0|0.81|5.15||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||5.15|0.81|0.1284
72358126|NCT03192176|144229980|SUPERIORITY||Odds Ratio (OR)|3.55||||0.0117|TWO_SIDED|95.0|1.32|9.5||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||9.50|1.32|0.0117
72358127|NCT03192176|144229980|SUPERIORITY||Odds Ratio (OR)|4.24||||0.0067|TWO_SIDED|95.0|1.49|12.03||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||12.03|1.49|0.0067
72358128|NCT03192176|144229980|SUPERIORITY||Odds Ratio (OR)|1.47||||0.4088|TWO_SIDED|95.0|0.59|3.71||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||3.71|0.59|0.4088
72358129|NCT03192176|144229980|SUPERIORITY||Odds Ratio (OR)|3.09||||0.0194|TWO_SIDED|95.0|1.2|7.96||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||7.96|1.20|0.0194
72358130|NCT03192176|144229980|SUPERIORITY||Odds Ratio (OR)|2.64||||0.0423|TWO_SIDED|95.0|1.03|6.73||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||6.73|1.03|0.0423
72358131|NCT03192176|144229980|SUPERIORITY||Odds Ratio (OR)|1.86||||0.2151|TWO_SIDED|95.0|0.7|4.99||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||4.99|0.70|0.2151
72358132|NCT03192176|144229980|SUPERIORITY||Odds Ratio (OR)|2.71||||0.0531|TWO_SIDED|95.0|0.99|7.42||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||7.42|0.99|0.0531
72358133|NCT03192176|144229980|SUPERIORITY||Odds Ratio (OR)|4.11||||0.0118|TWO_SIDED|95.0|1.37|12.34||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||12.34|1.37|0.0118
72358134|NCT03192176|144229980|SUPERIORITY||Odds Ratio (OR)|16.28||||0.0006|TWO_SIDED|95.0|3.29|80.46||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||80.46|3.29|0.0006
72358135|NCT03192176|144229980|SUPERIORITY||Odds Ratio (OR)|1.57||||0.3698|TWO_SIDED|95.0|0.59|4.22||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||4.22|0.59|0.3698
72358136|NCT03192176|144229980|SUPERIORITY||Odds Ratio (OR)|4.58||||0.0059|TWO_SIDED|95.0|1.55|13.53||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||13.53|1.55|0.0059
72358137|NCT03192176|144229980|SUPERIORITY||Odds Ratio (OR)|3.32||||0.0241|TWO_SIDED|95.0|1.17|9.44||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||9.44|1.17|0.0241
72358138|NCT03192176|144229980|SUPERIORITY||Odds Ratio (OR)|1.38||||0.5308|TWO_SIDED|95.0|0.5|3.77||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||3.77|0.50|0.5308
72358139|NCT03192176|144229980|SUPERIORITY||Odds Ratio (OR)|1.09||||0.8603|TWO_SIDED|95.0|0.41|2.9||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||2.90|0.41|0.8603
72358140|NCT03192176|144229980|SUPERIORITY||Odds Ratio (OR)|3.73||||0.0264|TWO_SIDED|95.0|1.17|11.95||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||11.95|1.17|0.0264
72358141|NCT03192176|144229980|SUPERIORITY||Odds Ratio (OR)|4.6||||0.0188|TWO_SIDED|95.0|1.29|16.42||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||16.42|1.29|0.0188
72358142|NCT03192176|144229980|SUPERIORITY||Odds Ratio (OR)|1.17||||0.7642|TWO_SIDED|95.0|0.42|3.27||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||3.27|0.42|0.7642
72358143|NCT03192176|144229980|SUPERIORITY||Odds Ratio (OR)|4.91||||0.0101|TWO_SIDED|95.0|1.46|16.53||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||16.53|1.46|0.0101
72358144|NCT03192176|144229980|SUPERIORITY||Odds Ratio (OR)|2.88||||0.0572|TWO_SIDED|95.0|0.97|8.55||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||8.55|0.97|0.0572
72358145|NCT03192176|144229980|SUPERIORITY||Odds Ratio (OR)|1.19||||0.7348|TWO_SIDED|95.0|0.44|3.2||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||3.20|0.44|0.7348
72429331|NCT01154036|144369664|SUPERIORITY_OR_OTHER_LEGACY||Difference in M-estimates|-5.3||||0.003|TWO_SIDED|95.0|-8.8|-1.8|||Multiple Imputation Robust Regression|M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values||||-1.8|-8.8|0.003
72358146|NCT03192176|144229980|SUPERIORITY||Odds Ratio (OR)|2.2||||0.1397|TWO_SIDED|95.0|0.77|6.25||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||6.25|0.77|0.1397
72358147|NCT03192176|144229980|SUPERIORITY||Odds Ratio (OR)|4.07||||0.0231|TWO_SIDED|95.0|1.21|13.64||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||13.64|1.21|0.0231
72358148|NCT03192176|144229980|SUPERIORITY||Odds Ratio (OR)|4.54||||0.0196|TWO_SIDED|95.0|1.27|16.15||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||16.15|1.27|0.0196
72358149|NCT03192176|144229980|SUPERIORITY||Odds Ratio (OR)|1.16||||0.7703|TWO_SIDED|95.0|0.42|3.24||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||3.24|0.42|0.7703
72358150|NCT03192176|144229980|SUPERIORITY||Odds Ratio (OR)|3.83||||0.0222|TWO_SIDED|95.0|1.21|12.12||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||12.12|1.21|0.0222
72358151|NCT03192176|144229980|SUPERIORITY||Odds Ratio (OR)|2.77||||0.0668|TWO_SIDED|95.0|0.93|8.21||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||8.21|0.93|0.0668
72358152|NCT03192176|144229980|SUPERIORITY||Odds Ratio (OR)|1.18||||0.7533|TWO_SIDED|95.0|0.43|3.22||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||3.22|0.43|0.7533
72358153|NCT03192176|144229980|SUPERIORITY||Odds Ratio (OR)|1.67||||0.3325|TWO_SIDED|95.0|0.59|4.73||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||4.73|0.59|0.3325
72358154|NCT03192176|144229980|SUPERIORITY||Odds Ratio (OR)|2.71||||0.0899|TWO_SIDED|95.0|0.86|8.57||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||8.57|0.86|0.0899
72358155|NCT03192176|144229980|SUPERIORITY||Odds Ratio (OR)|3.31||||0.0642|TWO_SIDED|95.0|0.93|11.79||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||11.79|0.93|0.0642
72358156|NCT03192176|144229980|SUPERIORITY||Odds Ratio (OR)|1.34||||0.5964|TWO_SIDED|95.0|0.46|3.89||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||3.89|0.46|0.5964
72358157|NCT03192176|144229980|SUPERIORITY||Odds Ratio (OR)|4.43||||0.0224|TWO_SIDED|95.0|1.23|15.91||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||15.91|1.23|0.0224
72358158|NCT03192176|144229980|SUPERIORITY||Odds Ratio (OR)|1.72||||0.3139|TWO_SIDED|95.0|0.6|4.96||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||4.96|0.60|0.3139
72358159|NCT03192176|144229980|SUPERIORITY||Odds Ratio (OR)|1.3||||0.6343|TWO_SIDED|95.0|0.45|3.76||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||3.76|0.45|0.6343
72358160|NCT03192176|144229980|SUPERIORITY||Odds Ratio (OR)|1.27||||0.6557|TWO_SIDED|95.0|0.45|3.61||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||3.61|0.45|0.6557
72358161|NCT03192176|144229980|SUPERIORITY||Odds Ratio (OR)|3.66||||0.0516|TWO_SIDED|95.0|0.99|13.51||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||13.51|0.99|0.0516
72358162|NCT03192176|144229980|SUPERIORITY||Odds Ratio (OR)|4.38||||0.04|TWO_SIDED|95.0|1.07|17.91||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||17.91|1.07|0.0400
72358163|NCT03192176|144229980|SUPERIORITY||Odds Ratio (OR)|1.37||||0.5825|TWO_SIDED|95.0|0.44|4.24||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||4.24|0.44|0.5825
72429332|NCT01154036|144369664|SUPERIORITY_OR_OTHER_LEGACY||Difference in M-estimates|-4.3||||0.011|TWO_SIDED|95.0|-7.7|-1.0|||Multiple Imputation Robust Regression|M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values||||-1.0|-7.7|0.011
72358164|NCT03192176|144229980|SUPERIORITY||Odds Ratio (OR)|7.46||||0.0152|TWO_SIDED|95.0|1.47|37.83||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||37.83|1.47|0.0152
72358165|NCT03192176|144229980|SUPERIORITY||Odds Ratio (OR)|2.3||||0.1565|TWO_SIDED|95.0|0.73|7.3||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||7.30|0.73|0.1565
72358166|NCT03192176|144229980|SUPERIORITY||Odds Ratio (OR)|1.45||||0.4932|TWO_SIDED|95.0|0.5|4.25||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||4.25|0.50|0.4932
72358167|NCT03192176|144229980|SUPERIORITY||Odds Ratio (OR)|1.11||||0.8504|TWO_SIDED|95.0|0.39|3.12||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||3.12|0.39|0.8504
72358168|NCT03192176|144229980|SUPERIORITY||Odds Ratio (OR)|3.07||||0.0759|TWO_SIDED|95.0|0.89|10.61||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||10.61|0.89|0.0759
72358169|NCT03192176|144229980|SUPERIORITY||Odds Ratio (OR)|3.69||||0.0477|TWO_SIDED|95.0|1.01|13.46||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||13.46|1.01|0.0477
72358170|NCT03192176|144229980|SUPERIORITY||Odds Ratio (OR)|2.47||||0.1448|TWO_SIDED|95.0|0.73|8.36||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||8.36|0.73|0.1448
72358171|NCT03192176|144229980|SUPERIORITY||Odds Ratio (OR)|5.54||||0.0173|TWO_SIDED|95.0|1.35|22.71||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||22.71|1.35|0.0173
72358172|NCT03192176|144229980|SUPERIORITY||Odds Ratio (OR)|2.57||||0.1101|TWO_SIDED|95.0|0.81|8.17||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||8.17|0.81|0.1101
72358173|NCT03192176|144229980|SUPERIORITY||Odds Ratio (OR)|1.32||||0.6022|TWO_SIDED|95.0|0.46|3.78||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||3.78|0.46|0.6022
72358174|NCT03192176|144229980|SUPERIORITY||Odds Ratio (OR)|1.31||||0.6128|TWO_SIDED|95.0|0.46|3.73||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||3.73|0.46|0.6128
72358175|NCT03192176|144229980|SUPERIORITY||Odds Ratio (OR)|2.82||||0.1001|TWO_SIDED|95.0|0.82|9.68||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||9.68|0.82|0.1001
72358176|NCT03192176|144229980|SUPERIORITY||Odds Ratio (OR)|4.95||||0.0255|TWO_SIDED|95.0|1.22|20.12||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||20.12|1.22|0.0255
72358177|NCT03192176|144229980|SUPERIORITY||Odds Ratio (OR)|2.42||||0.1521|TWO_SIDED|95.0|0.72|8.1||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||8.10|0.72|0.1521
72358178|NCT03192176|144229980|SUPERIORITY||Odds Ratio (OR)|9.37||||0.0071|TWO_SIDED|95.0|1.84|47.69||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||47.69|1.84|0.0071
72358179|NCT03192176|144229980|SUPERIORITY||Odds Ratio (OR)|2.52||||0.115|TWO_SIDED|95.0|0.8|7.93||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||7.93|0.80|0.1150
72358180|NCT03192176|144229980|SUPERIORITY||Odds Ratio (OR)|1.14||||0.8101|TWO_SIDED|95.0|0.4|3.22||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||3.22|0.40|0.8101
72358181|NCT03192176|144229980|SUPERIORITY||Odds Ratio (OR)|1.49||||0.4663|TWO_SIDED|95.0|0.51|4.33||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||4.33|0.51|0.4663
72429333|NCT01154036|144369665|SUPERIORITY_OR_OTHER_LEGACY||Difference in M-estimates|-4.3||||0.079|TWO_SIDED|95.0|-9.2|0.5|||Multiple Imputation Robust Regression|M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values||||0.5|-9.2|0.079
72358182|NCT03192176|144229980|SUPERIORITY||Odds Ratio (OR)|3.8||||0.0453|TWO_SIDED|95.0|1.03|14.01||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||14.01|1.03|0.0453
72358183|NCT03192176|144229980|SUPERIORITY||Odds Ratio (OR)|3.36||||0.0659|TWO_SIDED|95.0|0.92|12.21||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||12.21|0.92|0.0659
72358184|NCT03192176|144229980|SUPERIORITY||Odds Ratio (OR)|1.83||||0.3117|TWO_SIDED|95.0|0.57|5.86||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||5.86|0.57|0.3117
72358185|NCT03192176|144229980|SUPERIORITY||Odds Ratio (OR)|6.02||||0.0129|TWO_SIDED|95.0|1.46|24.73||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||24.73|1.46|0.0129
72358186|NCT03192176|144229980|SUPERIORITY||Odds Ratio (OR)|4.12||||0.0303|TWO_SIDED|95.0|1.14|14.83||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||14.83|1.14|0.0303
72358187|NCT03192176|144229980|SUPERIORITY||Odds Ratio (OR)|1.94||||0.2772|TWO_SIDED|95.0|0.59|6.42||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||6.42|0.59|0.2772
72358188|NCT03192176|144229980|SUPERIORITY||Odds Ratio (OR)|0.96||||0.9432|TWO_SIDED|95.0|0.29|3.16||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||3.16|0.29|0.9432
72358189|NCT03192176|144229980|SUPERIORITY||Odds Ratio (OR)|2.08||||0.2577|TWO_SIDED|95.0|0.59|7.36||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||7.36|0.59|0.2577
72358190|NCT03192176|144229980|SUPERIORITY||Odds Ratio (OR)|2.55||||0.1496|TWO_SIDED|95.0|0.71|9.12||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||9.12|0.71|0.1496
72358191|NCT03192176|144229980|SUPERIORITY||Odds Ratio (OR)|2.05||||0.2874|TWO_SIDED|95.0|0.55|7.67||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||7.67|0.55|0.2874
72358192|NCT03192176|144229980|SUPERIORITY||Odds Ratio (OR)|2.26||||0.1981|TWO_SIDED|95.0|0.65|7.78||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||7.78|0.65|0.1981
72358193|NCT03192176|144229980|SUPERIORITY||Odds Ratio (OR)|3.35||||0.0531|TWO_SIDED|95.0|0.98|11.43||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||11.43|0.98|0.0531
72358194|NCT03192176|144229980|SUPERIORITY||Odds Ratio (OR)|0.72||||0.5858|TWO_SIDED|95.0|0.22|2.35||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||2.35|0.22|0.5858
72358195|NCT03192176|144229980|SUPERIORITY||Odds Ratio (OR)|0.68||||0.5122|TWO_SIDED|95.0|0.21|2.16||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||2.16|0.21|0.5122
72358196|NCT03192176|144229980|SUPERIORITY||Odds Ratio (OR)|0.55||||0.3415|TWO_SIDED|95.0|0.16|1.89||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||1.89|0.16|0.3415
72358197|NCT03192176|144229980|SUPERIORITY||Odds Ratio (OR)|0.87||||0.8263|TWO_SIDED|95.0|0.25|2.98||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||2.98|0.25|0.8263
72358198|NCT03192176|144229980|SUPERIORITY||Odds Ratio (OR)|0.86||||0.8085|TWO_SIDED|95.0|0.24|3.03||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||3.03|0.24|0.8085
72358199|NCT03192176|144229980|SUPERIORITY||Odds Ratio (OR)|1.3||||0.6745|TWO_SIDED|95.0|0.38|4.43||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||4.43|0.38|0.6745
72429334|NCT01154036|144369665|SUPERIORITY_OR_OTHER_LEGACY||Difference in M-estimates|-7.7|||<|0.001|TWO_SIDED|95.0|-11.4|-4.1|||Multiple Imputation Robust Regression|M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values||||-4.1|-11.4|<0.001
72358200|NCT03192176|144229980|SUPERIORITY||Odds Ratio (OR)|1.08||||0.9019|TWO_SIDED|95.0|0.34|3.45||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||3.45|0.34|0.9019
72358201|NCT03192176|144229980|SUPERIORITY||Odds Ratio (OR)|0.62||||0.4425|TWO_SIDED|95.0|0.18|2.1||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||2.10|0.18|0.4425
72358202|NCT03192176|144229980|SUPERIORITY||Odds Ratio (OR)|0.54||||0.3106|TWO_SIDED|95.0|0.17|1.77||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||1.77|0.17|0.3106
72358203|NCT03192176|144229980|SUPERIORITY||Odds Ratio (OR)|0.32||||0.0912|TWO_SIDED|95.0|0.08|1.2||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||1.20|0.08|0.0912
72358204|NCT03192176|144229980|SUPERIORITY||Odds Ratio (OR)|0.7||||0.5681|TWO_SIDED|95.0|0.2|2.41||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||2.41|0.20|0.5681
72358205|NCT03192176|144229980|SUPERIORITY||Odds Ratio (OR)|0.58||||0.4261|TWO_SIDED|95.0|0.15|2.21||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||2.21|0.15|0.4261
72358206|NCT03192176|144229980|SUPERIORITY||Odds Ratio (OR)|0.82||||0.7514|TWO_SIDED|95.0|0.24|2.82||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||2.82|0.24|0.7514
72358207|NCT03192176|144229980|SUPERIORITY||Odds Ratio (OR)|0.52||||0.2712|TWO_SIDED|95.0|0.16|1.67||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||1.67|0.16|0.2712
72358208|NCT03192176|144229981|SUPERIORITY||Odds Ratio (OR)|4.89||||0.0103|TWO_SIDED|95.0|1.46|16.4||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||16.40|1.46|0.0103
72358209|NCT03192176|144229981|SUPERIORITY||Odds Ratio (OR)|7.19||||0.0011|TWO_SIDED|95.0|2.2|23.48||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||23.48|2.20|0.0011
72358210|NCT03192176|144229981|SUPERIORITY||Odds Ratio (OR)|11.06|||<|0.0001|TWO_SIDED|95.0|3.41|35.86||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||35.86|3.41|<0.0001
72358211|NCT03192176|144229981|SUPERIORITY||Odds Ratio (OR)|10.48||||0.0001|TWO_SIDED|95.0|3.18|34.55||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||34.55|3.18|0.0001
72358212|NCT03192176|144229981|SUPERIORITY||Odds Ratio (OR)|2.46||||0.1571|TWO_SIDED|95.0|0.71|8.55||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||8.55|0.71|0.1571
72358213|NCT03192176|144229981|SUPERIORITY||Odds Ratio (OR)|7.14||||0.001|TWO_SIDED|95.0|2.21|23.04||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||23.04|2.21|0.0010
72358214|NCT03192176|144229981|SUPERIORITY||Odds Ratio (OR)|7.35||||0.0008|TWO_SIDED|95.0|2.29|23.61||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||23.61|2.29|0.0008
72358215|NCT03192176|144229981|SUPERIORITY||Odds Ratio (OR)|2.78||||0.0342|TWO_SIDED|95.0|1.08|7.18||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||7.18|1.08|0.0342
72358216|NCT03192176|144229981|SUPERIORITY||Odds Ratio (OR)|2.98||||0.0231|TWO_SIDED|95.0|1.16|7.66||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||7.66|1.16|0.0231
72358217|NCT03192176|144229981|SUPERIORITY||Odds Ratio (OR)|4.12||||0.0032|TWO_SIDED|95.0|1.6|10.55||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||10.55|1.60|0.0032
72358218|NCT03192176|144229981|SUPERIORITY||Odds Ratio (OR)|3.89||||0.0059|TWO_SIDED|95.0|1.48|10.22||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||10.22|1.48|0.0059
72358219|NCT03192176|144229981|SUPERIORITY||Odds Ratio (OR)|1.76||||0.2471|TWO_SIDED|95.0|0.68|4.59||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||4.59|0.68|0.2471
72358220|NCT03192176|144229981|SUPERIORITY||Odds Ratio (OR)|2.66||||0.0381|TWO_SIDED|95.0|1.05|6.7||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||6.70|1.05|0.0381
72358221|NCT03192176|144229981|SUPERIORITY||Odds Ratio (OR)|3.34||||0.0113|TWO_SIDED|95.0|1.31|8.48||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||8.48|1.31|0.0113
72358222|NCT03192176|144229981|SUPERIORITY||Odds Ratio (OR)|2.56||||0.0486|TWO_SIDED|95.0|1.01|6.52||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||6.52|1.01|0.0486
72358223|NCT03192176|144229981|SUPERIORITY||Odds Ratio (OR)|2.71||||0.035|TWO_SIDED|95.0|1.07|6.87||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||6.87|1.07|0.0350
72358224|NCT03192176|144229981|SUPERIORITY||Odds Ratio (OR)|4.24||||0.0027|TWO_SIDED|95.0|1.65|10.9||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||10.90|1.65|0.0027
72358225|NCT03192176|144229981|SUPERIORITY||Odds Ratio (OR)|4.68||||0.002|TWO_SIDED|95.0|1.76|12.47||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||12.47|1.76|0.0020
72358226|NCT03192176|144229981|SUPERIORITY||Odds Ratio (OR)|2.41||||0.0686|TWO_SIDED|95.0|0.94|6.19||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||6.19|0.94|0.0686
72358227|NCT03192176|144229981|SUPERIORITY||Odds Ratio (OR)|4.02||||0.0034|TWO_SIDED|95.0|1.58|10.21||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||10.21|1.58|0.0034
72358228|NCT03192176|144229981|SUPERIORITY||Odds Ratio (OR)|2.9||||0.0222|TWO_SIDED|95.0|1.16|7.22||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||7.22|1.16|0.0222
72358229|NCT03192176|144229981|SUPERIORITY||Odds Ratio (OR)|2.28||||0.0876|TWO_SIDED|95.0|0.89|5.84||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||5.84|0.89|0.0876
72358230|NCT03192176|144229981|SUPERIORITY||Odds Ratio (OR)|2.72||||0.0345|TWO_SIDED|95.0|1.08|6.88||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||6.88|1.08|0.0345
72358231|NCT03192176|144229981|SUPERIORITY||Odds Ratio (OR)|2.76||||0.0319|TWO_SIDED|95.0|1.09|6.99||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||6.99|1.09|0.0319
72358232|NCT03192176|144229981|SUPERIORITY||Odds Ratio (OR)|5.27||||0.0013|TWO_SIDED|95.0|1.92|14.47||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||14.47|1.92|0.0013
72358233|NCT03192176|144229981|SUPERIORITY||Odds Ratio (OR)|1.91||||0.1751|TWO_SIDED|95.0|0.75|4.87||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||4.87|0.75|0.1751
72358234|NCT03192176|144229981|SUPERIORITY||Odds Ratio (OR)|4.46||||0.0019|TWO_SIDED|95.0|1.73|11.5||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||11.50|1.73|0.0019
72358235|NCT03192176|144229981|SUPERIORITY||Odds Ratio (OR)|2.79||||0.0284|TWO_SIDED|95.0|1.11|6.97||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||6.97|1.11|0.0284
72358236|NCT03192176|144229981|SUPERIORITY||Odds Ratio (OR)|1.72||||0.265|TWO_SIDED|95.0|0.66|4.45||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||4.45|0.66|0.2650
72358237|NCT03192176|144229981|SUPERIORITY||Odds Ratio (OR)|2.1||||0.1238|TWO_SIDED|95.0|0.82|5.38||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||5.38|0.82|0.1238
72358238|NCT03192176|144229981|SUPERIORITY||Odds Ratio (OR)|3.22||||0.0219|TWO_SIDED|95.0|1.18|8.74||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||8.74|1.18|0.0219
72358239|NCT03192176|144229981|SUPERIORITY||Odds Ratio (OR)|5.46||||0.0022|TWO_SIDED|95.0|1.84|16.16||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||16.16|1.84|0.0022
72358240|NCT03192176|144229981|SUPERIORITY||Odds Ratio (OR)|1.82||||0.223|TWO_SIDED|95.0|0.69|4.77||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||4.77|0.69|0.2230
72358241|NCT03192176|144229981|SUPERIORITY||Odds Ratio (OR)|5.05||||0.0018|TWO_SIDED|95.0|1.83|13.97||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||13.97|1.83|0.0018
72358242|NCT03192176|144229981|SUPERIORITY||Odds Ratio (OR)|3.17||||0.0205|TWO_SIDED|95.0|1.19|8.42||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||8.42|1.19|0.0205
72358243|NCT03192176|144229981|SUPERIORITY||Odds Ratio (OR)|1.44||||0.4628|TWO_SIDED|95.0|0.54|3.81||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||3.81|0.54|0.4628
72358244|NCT03192176|144229981|SUPERIORITY||Odds Ratio (OR)|1.51||||0.4015|TWO_SIDED|95.0|0.58|3.92||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||3.92|0.58|0.4015
72358245|NCT03192176|144229981|SUPERIORITY||Odds Ratio (OR)|5.39||||0.0031|TWO_SIDED|95.0|1.76|16.47||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||16.47|1.76|0.0031
72358246|NCT03192176|144229981|SUPERIORITY||Odds Ratio (OR)|4.15||||0.0115|TWO_SIDED|95.0|1.38|12.5||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||12.50|1.38|0.0115
72358247|NCT03192176|144229981|SUPERIORITY||Odds Ratio (OR)|1.81||||0.2513|TWO_SIDED|95.0|0.66|4.98||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||4.98|0.66|0.2513
72358248|NCT03192176|144229981|SUPERIORITY||Odds Ratio (OR)|3.94||||0.0099|TWO_SIDED|95.0|1.39|11.14||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||11.14|1.39|0.0099
72358249|NCT03192176|144229981|SUPERIORITY||Odds Ratio (OR)|3.19||||0.0242|TWO_SIDED|95.0|1.16|8.74||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||8.74|1.16|0.0242
72358250|NCT03192176|144229981|SUPERIORITY||Odds Ratio (OR)|2.07||||0.1518|TWO_SIDED|95.0|0.77|5.6||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||5.60|0.77|0.1518
72358251|NCT03192176|144229981|SUPERIORITY||Odds Ratio (OR)|1.95||||0.1811|TWO_SIDED|95.0|0.73|5.17||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||5.17|0.73|0.1811
72358252|NCT03192176|144229981|SUPERIORITY||Odds Ratio (OR)|3.88||||0.015|TWO_SIDED|95.0|1.3|11.55||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||11.55|1.30|0.0150
72358253|NCT03192176|144229981|SUPERIORITY||Odds Ratio (OR)|5.28||||0.0046|TWO_SIDED|95.0|1.67|16.68||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||16.68|1.67|0.0046
72358254|NCT03192176|144229981|SUPERIORITY||Odds Ratio (OR)|1.58||||0.3788|TWO_SIDED|95.0|0.57|4.34||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||4.34|0.57|0.3788
72358255|NCT03192176|144229981|SUPERIORITY||Odds Ratio (OR)|2.82||||0.0424|TWO_SIDED|95.0|1.04|7.7||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||7.70|1.04|0.0424
72358256|NCT03192176|144229981|SUPERIORITY||Odds Ratio (OR)|3.69||||0.0139|TWO_SIDED|95.0|1.3|10.43||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||10.43|1.30|0.0139
72358257|NCT03192176|144229981|SUPERIORITY||Odds Ratio (OR)|1.67||||0.3057|TWO_SIDED|95.0|0.63|4.42||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||4.42|0.63|0.3057
72358258|NCT03192176|144229981|SUPERIORITY||Odds Ratio (OR)|1.55||||0.3717|TWO_SIDED|95.0|0.59|4.02||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||4.02|0.59|0.3717
72358259|NCT03192176|144229981|SUPERIORITY||Odds Ratio (OR)|3.32||||0.0252|TWO_SIDED|95.0|1.16|9.5||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||9.50|1.16|0.0252
72358260|NCT03192176|144229981|SUPERIORITY||Odds Ratio (OR)|3.56||||0.0235|TWO_SIDED|95.0|1.19|10.69||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||10.69|1.19|0.0235
72358261|NCT03192176|144229981|SUPERIORITY||Odds Ratio (OR)|1.25||||0.658|TWO_SIDED|95.0|0.46|3.39||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||3.39|0.46|0.6580
72358262|NCT03192176|144229981|SUPERIORITY||Odds Ratio (OR)|4.58||||0.0061|TWO_SIDED|95.0|1.54|13.62||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||13.62|1.54|0.0061
72358263|NCT03192176|144229981|SUPERIORITY||Odds Ratio (OR)|3.7||||0.0149|TWO_SIDED|95.0|1.29|10.61||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||10.61|1.29|0.0149
72358264|NCT03192176|144229981|SUPERIORITY||Odds Ratio (OR)|0.95||||0.9282|TWO_SIDED|95.0|0.35|2.62||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||2.62|0.35|0.9282
72358265|NCT03192176|144229981|SUPERIORITY||Odds Ratio (OR)|0.87||||0.7902|TWO_SIDED|95.0|0.33|2.35||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||2.35|0.33|0.7902
72358266|NCT03192176|144229981|SUPERIORITY||Odds Ratio (OR)|2.22||||0.1603|TWO_SIDED|95.0|0.73|6.74||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||6.74|0.73|0.1603
72358267|NCT03192176|144229981|SUPERIORITY||Odds Ratio (OR)|2.55||||0.1144|TWO_SIDED|95.0|0.8|8.14||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||8.14|0.80|0.1144
72358268|NCT03192176|144229981|SUPERIORITY||Odds Ratio (OR)|0.75||||0.5903|TWO_SIDED|95.0|0.26|2.13||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||2.13|0.26|0.5903
72358269|NCT03192176|144229981|SUPERIORITY||Odds Ratio (OR)|3.89||||0.029|TWO_SIDED|95.0|1.15|13.16||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||13.16|1.15|0.0290
72358270|NCT03192176|144229981|SUPERIORITY||Odds Ratio (OR)|2.12||||0.1721|TWO_SIDED|95.0|0.72|6.26||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||6.26|0.72|0.1721
72358271|NCT03192176|144229981|SUPERIORITY||Odds Ratio (OR)|1.83||||0.2439|TWO_SIDED|95.0|0.66|5.09||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||5.09|0.66|0.2439
72429335|NCT01154036|144369666|SUPERIORITY_OR_OTHER_LEGACY||Difference in M-estimates|1.6||||0.156|TWO_SIDED|95.0|-0.6|3.8|||Multiple Imputation Robust Regression|M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values||||3.8|-0.6|0.156
72358272|NCT03192176|144229981|SUPERIORITY||Odds Ratio (OR)|1.18||||0.7402|TWO_SIDED|95.0|0.44|3.19||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||3.19|0.44|0.7402
72358273|NCT03192176|144229981|SUPERIORITY||Odds Ratio (OR)|3.17||||0.0422|TWO_SIDED|95.0|1.04|9.63||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||9.63|1.04|0.0422
72358274|NCT03192176|144229981|SUPERIORITY||Odds Ratio (OR)|5.44||||0.0061|TWO_SIDED|95.0|1.62|18.27||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||18.27|1.62|0.0061
72358275|NCT03192176|144229981|SUPERIORITY||Odds Ratio (OR)|1.71||||0.3191|TWO_SIDED|95.0|0.59|4.92||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||4.92|0.59|0.3191
72358276|NCT03192176|144229981|SUPERIORITY||Odds Ratio (OR)|5.91||||0.0037|TWO_SIDED|95.0|1.78|19.66||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||19.66|1.78|0.0037
72358277|NCT03192176|144229981|SUPERIORITY||Odds Ratio (OR)|4.02||||0.0139|TWO_SIDED|95.0|1.33|12.2||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||12.20|1.33|0.0139
72358278|NCT03192176|144229981|SUPERIORITY||Odds Ratio (OR)|1.59||||0.3757|TWO_SIDED|95.0|0.57|4.42||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||4.42|0.57|0.3757
72358279|NCT03192176|144229981|SUPERIORITY||Odds Ratio (OR)|1.21||||0.7087|TWO_SIDED|95.0|0.45|3.28||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||3.28|0.45|0.7087
72358280|NCT03192176|144229981|SUPERIORITY||Odds Ratio (OR)|2.53||||0.1083|TWO_SIDED|95.0|0.81|7.88||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||7.88|0.81|0.1083
72358281|NCT03192176|144229981|SUPERIORITY||Odds Ratio (OR)|3.21||||0.0473|TWO_SIDED|95.0|1.01|10.14||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||10.14|1.01|0.0473
72358282|NCT03192176|144229981|SUPERIORITY||Odds Ratio (OR)|1.89||||0.2481|TWO_SIDED|95.0|0.64|5.6||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||5.60|0.64|0.2481
72358283|NCT03192176|144229981|SUPERIORITY||Odds Ratio (OR)|5.84||||0.0066|TWO_SIDED|95.0|1.64|20.89||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||20.89|1.64|0.0066
72358284|NCT03192176|144229981|SUPERIORITY||Odds Ratio (OR)|3.06||||0.0466|TWO_SIDED|95.0|1.02|9.18||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||9.18|1.02|0.0466
72358285|NCT03192176|144229981|SUPERIORITY||Odds Ratio (OR)|0.92||||0.8769|TWO_SIDED|95.0|0.34|2.53||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||2.53|0.34|0.8769
72358286|NCT03192176|144229981|SUPERIORITY||Odds Ratio (OR)|1.37||||0.5448|TWO_SIDED|95.0|0.49|3.82||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||3.82|0.49|0.5448
72358287|NCT03192176|144229981|SUPERIORITY||Odds Ratio (OR)|1.57||||0.4125|TWO_SIDED|95.0|0.53|4.64||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||4.64|0.53|0.4125
72358288|NCT03192176|144229981|SUPERIORITY||Odds Ratio (OR)|3.36||||0.05|TWO_SIDED|95.0|1.0|11.3||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||11.30|1.00|0.0500
72358289|NCT03192176|144229981|SUPERIORITY||Odds Ratio (OR)|1.32||||0.6167|TWO_SIDED|95.0|0.45|3.87||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||3.87|0.45|0.6167
72429336|NCT01154036|144369666|SUPERIORITY_OR_OTHER_LEGACY||Difference in M-estimates|-0.9||||0.425|TWO_SIDED|95.0|-2.9|1.2|||Multiple Imputation Robust Regression|M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values||||1.2|-2.9|0.425
72358290|NCT03192176|144229981|SUPERIORITY||Odds Ratio (OR)|4.0||||0.0233|TWO_SIDED|95.0|1.21|13.26||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||13.26|1.21|0.0233
72358291|NCT03192176|144229981|SUPERIORITY||Odds Ratio (OR)|2.68||||0.0803|TWO_SIDED|95.0|0.89|8.09||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||8.09|0.89|0.0803
72358292|NCT03192176|144229981|SUPERIORITY||Odds Ratio (OR)|2.64||||0.1274|TWO_SIDED|95.0|0.76|9.18||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||9.18|0.76|0.1274
72358293|NCT03192176|144229981|SUPERIORITY||Odds Ratio (OR)|1.05||||0.9445|TWO_SIDED|95.0|0.29|3.71||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||3.71|0.29|0.9445
72358294|NCT03192176|144229981|SUPERIORITY||Odds Ratio (OR)|1.69||||0.4204|TWO_SIDED|95.0|0.47|6.03||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||6.03|0.47|0.4204
72358295|NCT03192176|144229981|SUPERIORITY||Odds Ratio (OR)|2.78||||0.1315|TWO_SIDED|95.0|0.74|10.49||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||10.49|0.74|0.1315
72358296|NCT03192176|144229981|SUPERIORITY||Odds Ratio (OR)|3.24||||0.0944|TWO_SIDED|95.0|0.82|12.87||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||12.87|0.82|0.0944
72358297|NCT03192176|144229981|SUPERIORITY||Odds Ratio (OR)|1.99||||0.2801|TWO_SIDED|95.0|0.57|6.89||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||6.89|0.57|0.2801
72358298|NCT03192176|144229981|SUPERIORITY||Odds Ratio (OR)|2.44||||0.1524|TWO_SIDED|95.0|0.72|8.3||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||8.30|0.72|0.1524
72358299|NCT03192176|144229981|SUPERIORITY||Odds Ratio (OR)|1.38||||0.6129|TWO_SIDED|95.0|0.4|4.75||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||4.75|0.40|0.6129
72358300|NCT03192176|144229981|SUPERIORITY||Odds Ratio (OR)|0.63||||0.4617|TWO_SIDED|95.0|0.18|2.18||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||2.18|0.18|0.4617
72358301|NCT03192176|144229981|SUPERIORITY||Odds Ratio (OR)|0.74||||0.6519|TWO_SIDED|95.0|0.2|2.7||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||2.70|0.20|0.6519
72358302|NCT03192176|144229981|SUPERIORITY||Odds Ratio (OR)|0.84||||0.8011|TWO_SIDED|95.0|0.22|3.18||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||3.18|0.22|0.8011
72358303|NCT03192176|144229981|SUPERIORITY||Odds Ratio (OR)|1.95||||0.3254|TWO_SIDED|95.0|0.51|7.41||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||7.41|0.51|0.3254
72358304|NCT03192176|144229981|SUPERIORITY||Odds Ratio (OR)|2.0||||0.273|TWO_SIDED|95.0|0.58|6.94||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||6.94|0.58|0.2730
72358305|NCT03192176|144229981|SUPERIORITY||Odds Ratio (OR)|1.31||||0.6601|TWO_SIDED|95.0|0.39|4.41||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||4.41|0.39|0.6601
72358306|NCT03192176|144229981|SUPERIORITY||Odds Ratio (OR)|0.74||||0.6588|TWO_SIDED|95.0|0.2|2.76||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||2.76|0.20|0.6588
72358307|NCT03192176|144229981|SUPERIORITY||Odds Ratio (OR)|0.52||||0.3257|TWO_SIDED|95.0|0.14|1.92||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||1.92|0.14|0.3257
72358308|NCT03192176|144229981|SUPERIORITY||Odds Ratio (OR)|0.42||||0.2229|TWO_SIDED|95.0|0.1|1.69||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||1.69|0.10|0.2229
72358309|NCT03192176|144229981|SUPERIORITY||Odds Ratio (OR)|0.43||||0.2425|TWO_SIDED|95.0|0.1|1.77||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||1.77|0.10|0.2425
72358310|NCT03192176|144229981|SUPERIORITY||Odds Ratio (OR)|0.97||||0.9672|TWO_SIDED|95.0|0.23|4.11||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||4.11|0.23|0.9672
72358311|NCT03192176|144229981|SUPERIORITY||Odds Ratio (OR)|1.43||||0.5838|TWO_SIDED|95.0|0.4|5.09||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||5.09|0.40|0.5838
72358312|NCT03192176|144229981|SUPERIORITY||Odds Ratio (OR)|0.95||||0.9361|TWO_SIDED|95.0|0.28|3.24||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||3.24|0.28|0.9361
72358313|NCT03192176|144229982|SUPERIORITY||Odds Ratio (OR)|2.6||||0.0429|TWO_SIDED|95.0|1.03|6.55||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||6.55|1.03|0.0429
72358314|NCT03192176|144229982|SUPERIORITY||Odds Ratio (OR)|2.81||||0.0296|TWO_SIDED|95.0|1.11|7.12||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||7.12|1.11|0.0296
72358315|NCT03192176|144229982|SUPERIORITY||Odds Ratio (OR)|4.48||||0.0032|TWO_SIDED|95.0|1.65|12.13||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||12.13|1.65|0.0032
72358316|NCT03192176|144229982|SUPERIORITY||Odds Ratio (OR)|7.11||||0.0006|TWO_SIDED|95.0|2.31|21.9||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||21.90|2.31|0.0006
72358317|NCT03192176|144229982|SUPERIORITY||Odds Ratio (OR)|1.8||||0.2073|TWO_SIDED|95.0|0.72|4.47||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||4.47|0.72|0.2073
72358318|NCT03192176|144229982|SUPERIORITY||Odds Ratio (OR)|3.54||||0.0096|TWO_SIDED|95.0|1.36|9.2||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||9.20|1.36|0.0096
72358319|NCT03192176|144229982|SUPERIORITY||Odds Ratio (OR)|2.52||||0.0462|TWO_SIDED|95.0|1.02|6.27||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||6.27|1.02|0.0462
72358320|NCT03192176|144229982|SUPERIORITY||Odds Ratio (OR)|2.26||||0.1387|TWO_SIDED|95.0|0.77|6.63||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||6.63|0.77|0.1387
72358321|NCT03192176|144229982|SUPERIORITY||Odds Ratio (OR)|1.71||||0.313|TWO_SIDED|95.0|0.6|4.84||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||4.84|0.60|0.3130
72358322|NCT03192176|144229982|SUPERIORITY||Odds Ratio (OR)|3.32||||0.0392|TWO_SIDED|95.0|1.06|10.4||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||10.40|1.06|0.0392
72358323|NCT03192176|144229982|SUPERIORITY||Odds Ratio (OR)|5.7||||0.0135|TWO_SIDED|95.0|1.43|22.71||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||22.71|1.43|0.0135
72358324|NCT03192176|144229982|SUPERIORITY||Odds Ratio (OR)|2.85||||0.084|TWO_SIDED|95.0|0.87|9.36||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||9.36|0.87|0.0840
72358325|NCT03192176|144229982|SUPERIORITY||Odds Ratio (OR)|4.47||||0.0163|TWO_SIDED|95.0|1.32|15.17||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||15.17|1.32|0.0163
72358326|NCT03192176|144229982|SUPERIORITY||Odds Ratio (OR)|1.41||||0.5056|TWO_SIDED|95.0|0.52|3.84||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||3.84|0.52|0.5056
72429337|NCT01154036|144369667|SUPERIORITY_OR_OTHER_LEGACY||Difference in M-estimates|0.5||||0.739|TWO_SIDED|95.0|-2.5|3.6|||Multiple Imputation Robust Regression|M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values||||3.6|-2.5|0.739
72358327|NCT03192176|144229982|SUPERIORITY||Odds Ratio (OR)|1.69||||0.3358|TWO_SIDED|95.0|0.58|4.9||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||4.90|0.58|0.3358
72358328|NCT03192176|144229982|SUPERIORITY||Odds Ratio (OR)|3.05||||0.0696|TWO_SIDED|95.0|0.91|10.18||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||10.18|0.91|0.0696
72358329|NCT03192176|144229982|SUPERIORITY||Odds Ratio (OR)|2.8||||0.0794|TWO_SIDED|95.0|0.89|8.82||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||8.82|0.89|0.0794
72358330|NCT03192176|144229982|SUPERIORITY||Odds Ratio (OR)|7.32||||0.0149|TWO_SIDED|95.0|1.48|36.28||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||36.28|1.48|0.0149
72358331|NCT03192176|144229982|SUPERIORITY||Odds Ratio (OR)|4.37||||0.0377|TWO_SIDED|95.0|1.09|17.59||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||17.59|1.09|0.0377
72358332|NCT03192176|144229982|SUPERIORITY||Odds Ratio (OR)|3.32||||0.0454|TWO_SIDED|95.0|1.03|10.77||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||10.77|1.03|0.0454
72358333|NCT03192176|144229982|SUPERIORITY||Odds Ratio (OR)|3.77||||0.039|TWO_SIDED|95.0|1.07|13.26||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||13.26|1.07|0.0390
72358334|NCT03192176|144229982|SUPERIORITY||Odds Ratio (OR)|2.12||||0.1947|TWO_SIDED|95.0|0.68|6.64||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||6.64|0.68|0.1947
72358335|NCT03192176|144229982|SUPERIORITY||Odds Ratio (OR)|1.79||||0.2913|TWO_SIDED|95.0|0.61|5.25||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||5.25|0.61|0.2913
72358336|NCT03192176|144229982|SUPERIORITY||Odds Ratio (OR)|2.21||||0.1665|TWO_SIDED|95.0|0.72|6.82||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||6.82|0.72|0.1665
72358337|NCT03192176|144229982|SUPERIORITY||Odds Ratio (OR)|13.41||||0.0157|TWO_SIDED|95.0|1.63|110.3||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||110.3|1.63|0.0157
72358338|NCT03192176|144229982|SUPERIORITY||Odds Ratio (OR)|3.01||||0.0846|TWO_SIDED|95.0|0.86|10.49||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||10.49|0.86|0.0846
72358339|NCT03192176|144229982|SUPERIORITY||Odds Ratio (OR)|5.42||||0.0171|TWO_SIDED|95.0|1.35|21.75||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||21.75|1.35|0.0171
72358340|NCT03192176|144229982|SUPERIORITY||Odds Ratio (OR)|4.71||||0.0262|TWO_SIDED|95.0|1.2|18.49||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||18.49|1.20|0.0262
72358341|NCT03192176|144229982|SUPERIORITY||Odds Ratio (OR)|1.88||||0.2858|TWO_SIDED|95.0|0.59|5.95||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||5.95|0.59|0.2858
72358342|NCT03192176|144229982|SUPERIORITY||Odds Ratio (OR)|7.65||||0.0155|TWO_SIDED|95.0|1.47|39.72||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||39.72|1.47|0.0155
72358343|NCT03192176|144229982|SUPERIORITY||Odds Ratio (OR)|2.66||||0.1249|TWO_SIDED|95.0|0.76|9.31||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||9.31|0.76|0.1249
72358344|NCT03192176|144229982|SUPERIORITY||Odds Ratio (OR)|3.85||||0.0616|TWO_SIDED|95.0|0.94|15.82||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||15.82|0.94|0.0616
72429338|NCT01154036|144369667|SUPERIORITY_OR_OTHER_LEGACY||Difference in M-estimates|-1.0||||0.41|TWO_SIDED|95.0|-3.3|1.3|||Multiple Imputation Robust Regression|M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values||||1.3|-3.3|0.410
72358345|NCT03192176|144229982|SUPERIORITY||Odds Ratio (OR)|8.32||||0.0126|TWO_SIDED|95.0|1.58|43.9||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||43.90|1.58|0.0126
72358346|NCT03192176|144229982|SUPERIORITY||Odds Ratio (OR)|3.1||||0.0853|TWO_SIDED|95.0|0.85|11.23||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||11.23|0.85|0.0853
72358347|NCT03192176|144229982|SUPERIORITY||Odds Ratio (OR)|2.56||||0.1562|TWO_SIDED|95.0|0.7|9.35||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||9.35|0.70|0.1562
72358348|NCT03192176|144229982|SUPERIORITY||Odds Ratio (OR)|2.83||||0.1297|TWO_SIDED|95.0|0.74|10.91||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||10.91|0.74|0.1297
72358349|NCT03192176|144229982|SUPERIORITY||Odds Ratio (OR)|2.34||||0.2001|TWO_SIDED|95.0|0.64|8.55||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||8.55|0.64|0.2001
72358350|NCT03192176|144229982|SUPERIORITY||Odds Ratio (OR)|8.6||||0.0495|TWO_SIDED|95.0|1.0|73.7||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||73.70|1.00|0.0495
72358351|NCT03192176|144229982|SUPERIORITY||Odds Ratio (OR)|2.86||||0.1553|TWO_SIDED|95.0|0.67|12.2||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||12.20|0.67|0.1553
72358352|NCT03192176|144229982|SUPERIORITY||Odds Ratio (OR)|7.67||||0.0199|TWO_SIDED|95.0|1.38|42.67||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||42.67|1.38|0.0199
72358353|NCT03192176|144229982|SUPERIORITY||Odds Ratio (OR)|5.28||||0.0472|TWO_SIDED|95.0|1.02|27.34||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||27.34|1.02|0.0472
72358354|NCT03192176|144229982|SUPERIORITY||Odds Ratio (OR)|1.75||||0.3736|TWO_SIDED|95.0|0.51|5.98||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||5.98|0.51|0.3736
72358355|NCT03192176|144229982|SUPERIORITY||Odds Ratio (OR)|2.06||||0.2628|TWO_SIDED|95.0|0.58|7.26||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||7.26|0.58|0.2628
72358356|NCT03192176|144229982|SUPERIORITY||Odds Ratio (OR)|2.43||||0.1998|TWO_SIDED|95.0|0.63|9.39||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||9.39|0.63|0.1998
72358357|NCT03192176|144229982|SUPERIORITY||Odds Ratio (OR)|2.89||||0.1507|TWO_SIDED|95.0|0.68|12.28||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||12.28|0.68|0.1507
72358358|NCT03192176|144229982|SUPERIORITY||Odds Ratio (OR)|5.92||||0.0385|TWO_SIDED|95.0|1.1|31.94||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||31.94|1.10|0.0385
72358359|NCT03192176|144229982|SUPERIORITY||Odds Ratio (OR)|10.85||||0.0299|TWO_SIDED|95.0|1.26|93.28||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||93.28|1.26|0.0299
72358360|NCT03192176|144229982|SUPERIORITY||Odds Ratio (OR)|1.19||||0.8034|TWO_SIDED|95.0|0.3|4.74||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||4.74|0.30|0.8034
72358361|NCT03192176|144229982|SUPERIORITY||Odds Ratio (OR)|1.14||||0.8532|TWO_SIDED|95.0|0.29|4.42||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||4.42|0.29|0.8532
72358362|NCT03192176|144229982|SUPERIORITY||Odds Ratio (OR)|1.11||||0.8823|TWO_SIDED|95.0|0.28|4.41||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||4.41|0.28|0.8823
72429339|NCT01154036|144369668|SUPERIORITY_OR_OTHER_LEGACY||Difference in M-estimates|-10.1|||<|0.001|TWO_SIDED|95.0|-13.6|-6.6|||Multiple Imputation Robust Regression|M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values||||-6.6|-13.6|<0.001
72358363|NCT03192176|144229982|SUPERIORITY||Odds Ratio (OR)|4.79||||0.1651|TWO_SIDED|95.0|0.52|43.76||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||43.76|0.52|0.1651
72358364|NCT03192176|144229982|SUPERIORITY||Odds Ratio (OR)|6.36||||0.1048|TWO_SIDED|95.0|0.68|59.55||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||59.55|0.68|0.1048
72358365|NCT03192176|144229982|SUPERIORITY||Odds Ratio (OR)|5.87||||0.1168|TWO_SIDED|95.0|0.64|53.53||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||53.53|0.64|0.1168
72358366|NCT03192176|144229982|SUPERIORITY||Odds Ratio (OR)|1.31||||0.6936|TWO_SIDED|95.0|0.35|4.95||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||4.95|0.35|0.6936
72358367|NCT03192176|144229982|SUPERIORITY||Odds Ratio (OR)|1.74||||0.4315|TWO_SIDED|95.0|0.44|6.9||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||6.90|0.44|0.4315
72358368|NCT03192176|144229982|SUPERIORITY||Odds Ratio (OR)|1.19||||0.7936|TWO_SIDED|95.0|0.31|4.53||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||4.53|0.31|0.7936
72358369|NCT03192176|144229982|SUPERIORITY||Odds Ratio (OR)|6.3||||0.099|TWO_SIDED|95.0|0.71|56.03||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||56.03|0.71|0.0990
72358370|NCT03192176|144229982|SUPERIORITY||Odds Ratio (OR)|5.86||||0.1128|TWO_SIDED|95.0|0.66|52.21||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||52.21|0.66|0.1128
72358371|NCT03192176|144229982|SUPERIORITY||Odds Ratio (OR)|7.36||||0.0732|TWO_SIDED|95.0|0.83|65.38||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||65.38|0.83|0.0732
72358372|NCT03192176|144229982|SUPERIORITY||Odds Ratio (OR)|1.39||||0.6559|TWO_SIDED|95.0|0.33|5.91||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||5.91|0.33|0.6559
72358373|NCT03192176|144229982|SUPERIORITY||Odds Ratio (OR)|0.8||||0.7333|TWO_SIDED|95.0|0.21|2.96||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||2.96|0.21|0.7333
72358374|NCT03192176|144229982|SUPERIORITY||Odds Ratio (OR)|0.94||||0.9266|TWO_SIDED|95.0|0.24|3.74||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||3.74|0.24|0.9266
72358375|NCT03192176|144229982|SUPERIORITY||Odds Ratio (OR)|5.04||||0.1518|TWO_SIDED|95.0|0.55|46.13||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||46.13|0.55|0.1518
72358376|NCT03192176|144229982|SUPERIORITY||Odds Ratio (OR)|4.69||||0.1714|TWO_SIDED|95.0|0.51|42.91||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||42.91|0.51|0.1714
72358377|NCT03192176|144229982|SUPERIORITY||Odds Ratio (OR)|5.6||||0.1299|TWO_SIDED|95.0|0.6|51.95||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||51.95|0.60|0.1299
72358378|NCT03192176|144229982|SUPERIORITY||Odds Ratio (OR)|2.75||||0.2495|TWO_SIDED|95.0|0.49|15.44||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||15.44|0.49|0.2495
72358379|NCT03192176|144229982|SUPERIORITY||Odds Ratio (OR)|1.32||||0.7065|TWO_SIDED|95.0|0.31|5.6||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||5.60|0.31|0.7065
72429340|NCT01154036|144369668|SUPERIORITY_OR_OTHER_LEGACY||Difference in M-estimates|-7.6|||<|0.001|TWO_SIDED|95.0|-10.9|-4.3|||Multiple Imputation Robust Regression|M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values||||-4.3|-10.9|<0.001
72429341|NCT01154036|144369669|SUPERIORITY_OR_OTHER_LEGACY||Difference in M-estimates|-9.3|||<|0.001|TWO_SIDED|95.0|-14.0|-4.5|||Multiple Imputation Robust Regression|M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values||||-4.5|-14.0|<0.001
72358380|NCT03192176|144229982|SUPERIORITY||Odds Ratio (OR)|1.26||||0.7504|TWO_SIDED|95.0|0.3|5.24||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||5.24|0.30|0.7504
72358381|NCT03192176|144229982|SUPERIORITY||Odds Ratio (OR)|0.83||||0.7862|TWO_SIDED|95.0|0.21|3.29||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||3.29|0.21|0.7862
72358382|NCT03192176|144229982|SUPERIORITY||Odds Ratio (OR)|4.98||||0.155|TWO_SIDED|95.0|0.54|45.59||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||45.59|0.54|0.1550
72358383|NCT03192176|144229982|SUPERIORITY||Odds Ratio (OR)|4.7||||0.1706|TWO_SIDED|95.0|0.51|42.96||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||42.96|0.51|0.1706
72358384|NCT03192176|144229982|SUPERIORITY||Odds Ratio (OR)|5.31||||0.1415|TWO_SIDED|95.0|0.57|49.11||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||49.11|0.57|0.1415
72358385|NCT03192176|144229982|SUPERIORITY||Odds Ratio (OR)|5.67||||0.1241|TWO_SIDED|95.0|0.62|51.74||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||51.74|0.62|0.1241
72358386|NCT03192176|144229982|SUPERIORITY||Odds Ratio (OR)|2.64||||0.2169|TWO_SIDED|95.0|0.57|12.29||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||12.29|0.57|0.2169
72358387|NCT03192176|144229982|SUPERIORITY||Odds Ratio (OR)|1.0||||0.9982|TWO_SIDED|95.0|0.28|3.6||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||3.60|0.28|0.9982
72358388|NCT03192176|144229982|SUPERIORITY||Odds Ratio (OR)|1.57||||0.5364|TWO_SIDED|95.0|0.38|6.54||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||6.54|0.38|0.5364
72429342|NCT01154036|144369669|SUPERIORITY_OR_OTHER_LEGACY||Difference in M-estimates|-9.8||||0.001|TWO_SIDED|95.0|-13.5|-6.2|||Multiple Imputation Robust Regression|M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values||||-6.2|-13.5|0.001
72358389|NCT03192176|144229982|SUPERIORITY||Odds Ratio (OR)|5.68||||0.121|TWO_SIDED|95.0|0.63|51.07||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||51.07|0.63|0.1210
72358390|NCT03192176|144229982|SUPERIORITY||Odds Ratio (OR)|7.65||||0.0726|TWO_SIDED|95.0|0.83|70.58||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||70.58|0.83|0.0726
72358391|NCT03192176|144229982|SUPERIORITY||Odds Ratio (OR)|7.34||||0.0749|TWO_SIDED|95.0|0.82|65.81||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||65.81|0.82|0.0749
72358392|NCT03192176|144229982|SUPERIORITY||Odds Ratio (OR)|4.01||||0.053|TWO_SIDED|95.0|0.98|16.35||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||16.35|0.98|0.0530
72358393|NCT03192176|144229982|SUPERIORITY||Odds Ratio (OR)|2.32||||0.2134|TWO_SIDED|95.0|0.62|8.72||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||8.72|0.62|0.2134
72358394|NCT03192176|144229982|SUPERIORITY||Odds Ratio (OR)|1.88||||0.3688|TWO_SIDED|95.0|0.48|7.41||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||7.41|0.48|0.3688
72358395|NCT03192176|144229982|SUPERIORITY||Odds Ratio (OR)|4.61||||0.0563|TWO_SIDED|95.0|0.96|22.11||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||22.11|0.96|0.0563
72358396|NCT03192176|144229982|SUPERIORITY||Odds Ratio (OR)|3.94||||0.0935|TWO_SIDED|95.0|0.79|19.52||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||19.52|0.79|0.0935
72429343|NCT01154036|144369670|SUPERIORITY_OR_OTHER_LEGACY||Difference in M-estimates|-8.1|||<|0.001|TWO_SIDED|95.0|-11.2|-4.9|||Multiple Imputation Robust Regression|M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values||||-4.9|-11.2|<0.001
72358397|NCT03192176|144229982|SUPERIORITY||Odds Ratio (OR)|3.71||||0.0901|TWO_SIDED|95.0|0.81|16.93||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||16.93|0.81|0.0901
72358398|NCT03192176|144229982|SUPERIORITY||Odds Ratio (OR)|2.84||||0.1366|TWO_SIDED|95.0|0.72|11.26||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||11.26|0.72|0.1366
72358399|NCT03192176|144229982|SUPERIORITY||Odds Ratio (OR)|1.19||||0.7876|TWO_SIDED|95.0|0.34|4.08||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||4.08|0.34|0.7876
72358400|NCT03192176|144229982|SUPERIORITY||Odds Ratio (OR)|1.59||||0.4658|TWO_SIDED|95.0|0.45|5.59||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||5.59|0.45|0.4658
72358401|NCT03192176|144229982|SUPERIORITY||Odds Ratio (OR)|0.9||||0.8707|TWO_SIDED|95.0|0.25|3.2||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||3.20|0.25|0.8707
72358402|NCT03192176|144229982|SUPERIORITY||Odds Ratio (OR)|1.89||||0.3584|TWO_SIDED|95.0|0.49|7.36||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||7.36|0.49|0.3584
72358403|NCT03192176|144229982|SUPERIORITY||Odds Ratio (OR)|3.13||||0.1455|TWO_SIDED|95.0|0.67|14.57||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||14.57|0.67|0.1455
72358404|NCT03192176|144229982|SUPERIORITY||Odds Ratio (OR)|5.07||||0.0661|TWO_SIDED|95.0|0.9|28.66||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||28.66|0.90|0.0661
72358405|NCT03192176|144229982|SUPERIORITY||Odds Ratio (OR)|1.97||||0.3034|TWO_SIDED|95.0|0.54|7.17||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||7.17|0.54|0.3034
72358406|NCT03192176|144229982|SUPERIORITY||Odds Ratio (OR)|1.01||||0.9901|TWO_SIDED|95.0|0.28|3.6||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||3.60|0.28|0.9901
72358407|NCT03192176|144229982|SUPERIORITY||Odds Ratio (OR)|1.55||||0.507|TWO_SIDED|95.0|0.42|5.68||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||5.68|0.42|0.5070
72358408|NCT03192176|144229982|SUPERIORITY||Odds Ratio (OR)|0.83||||0.7927|TWO_SIDED|95.0|0.21|3.26||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||3.26|0.21|0.7927
72358409|NCT03192176|144229982|SUPERIORITY||Odds Ratio (OR)|1.71||||0.4426|TWO_SIDED|95.0|0.44|6.69||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||6.69|0.44|0.4426
72358410|NCT03192176|144229982|SUPERIORITY||Odds Ratio (OR)|0.91||||0.8925|TWO_SIDED|95.0|0.23|3.56||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||3.56|0.23|0.8925
72358411|NCT03192176|144229982|SUPERIORITY||Odds Ratio (OR)|1.79||||0.4285|TWO_SIDED|95.0|0.42|7.52||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||7.52|0.42|0.4285
72358412|NCT03192176|144229982|SUPERIORITY||Odds Ratio (OR)|1.08||||0.9|TWO_SIDED|95.0|0.31|3.72||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||3.72|0.31|0.9000
72358413|NCT03192176|144229983|SUPERIORITY||Odds Ratio (OR)|2.41||||0.0602|TWO_SIDED|95.0|0.96|6.06||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||6.06|0.96|0.0602
72358414|NCT03192176|144229983|SUPERIORITY||Odds Ratio (OR)|4.88||||0.001|TWO_SIDED|95.0|1.89|12.57||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||12.57|1.89|0.0010
72429344|NCT01154036|144369670|SUPERIORITY_OR_OTHER_LEGACY||Difference in M-estimates|-4.8||||0.001|TWO_SIDED|95.0|-7.8|-1.9|||Multiple Imputation Robust Regression|M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values||||-1.9|-7.8|0.001
72358415|NCT03192176|144229983|SUPERIORITY||Odds Ratio (OR)|5.24||||0.0006|TWO_SIDED|95.0|2.03|13.51||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||13.51|2.03|0.0006
72358416|NCT03192176|144229983|SUPERIORITY||Odds Ratio (OR)|9.07|||<|0.0001|TWO_SIDED|95.0|3.23|25.45||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||25.45|3.23|<0.0001
72358417|NCT03192176|144229983|SUPERIORITY||Odds Ratio (OR)|2.06||||0.1259|TWO_SIDED|95.0|0.82|5.22||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||5.22|0.82|0.1259
72358418|NCT03192176|144229983|SUPERIORITY||Odds Ratio (OR)|7.05|||<|0.0001|TWO_SIDED|95.0|2.65|18.71||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||18.71|2.65|<0.0001
72358419|NCT03192176|144229983|SUPERIORITY||Odds Ratio (OR)|3.51||||0.007|TWO_SIDED|95.0|1.41|8.76||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||8.76|1.41|0.0070
72358420|NCT03192176|144229983|SUPERIORITY||Odds Ratio (OR)|3.15||||0.0193|TWO_SIDED|95.0|1.2|8.23||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||8.23|1.20|0.0193
72358421|NCT03192176|144229983|SUPERIORITY||Odds Ratio (OR)|3.34||||0.0148|TWO_SIDED|95.0|1.27|8.81||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||8.81|1.27|0.0148
72358422|NCT03192176|144229983|SUPERIORITY||Odds Ratio (OR)|5.05||||0.0018|TWO_SIDED|95.0|1.83|13.94||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||13.94|1.83|0.0018
72358423|NCT03192176|144229983|SUPERIORITY||Odds Ratio (OR)|7.27||||0.0007|TWO_SIDED|95.0|2.32|22.78||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||22.78|2.32|0.0007
72358424|NCT03192176|144229983|SUPERIORITY||Odds Ratio (OR)|3.11||||0.0246|TWO_SIDED|95.0|1.16|8.35||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||8.35|1.16|0.0246
72358425|NCT03192176|144229983|SUPERIORITY||Odds Ratio (OR)|5.22||||0.0016|TWO_SIDED|95.0|1.87|14.6||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||14.60|1.87|0.0016
72358426|NCT03192176|144229983|SUPERIORITY||Odds Ratio (OR)|2.25||||0.0825|TWO_SIDED|95.0|0.9|5.62||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||5.62|0.90|0.0825
72358427|NCT03192176|144229983|SUPERIORITY||Odds Ratio (OR)|2.66||||0.0542|TWO_SIDED|95.0|0.98|7.2||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||7.20|0.98|0.0542
72358428|NCT03192176|144229983|SUPERIORITY||Odds Ratio (OR)|2.38||||0.0837|TWO_SIDED|95.0|0.89|6.33||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||6.33|0.89|0.0837
72358429|NCT03192176|144229983|SUPERIORITY||Odds Ratio (OR)|3.67||||0.0131|TWO_SIDED|95.0|1.31|10.26||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||10.26|1.31|0.0131
72358430|NCT03192176|144229983|SUPERIORITY||Odds Ratio (OR)|9.34||||0.0012|TWO_SIDED|95.0|2.41|36.19||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||36.19|2.41|0.0012
72358431|NCT03192176|144229983|SUPERIORITY||Odds Ratio (OR)|3.1||||0.0359|TWO_SIDED|95.0|1.08|8.93||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||8.93|1.08|0.0359
72358432|NCT03192176|144229983|SUPERIORITY||Odds Ratio (OR)|5.86||||0.0019|TWO_SIDED|95.0|1.91|17.92||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||17.92|1.91|0.0019
72358433|NCT03192176|144229983|SUPERIORITY||Odds Ratio (OR)|2.43||||0.0715|TWO_SIDED|95.0|0.93|6.38||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||6.38|0.93|0.0715
72358434|NCT03192176|144229983|SUPERIORITY||Odds Ratio (OR)|2.89||||0.0465|TWO_SIDED|95.0|1.02|8.2||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||8.20|1.02|0.0465
72358435|NCT03192176|144229983|SUPERIORITY||Odds Ratio (OR)|2.41||||0.0839|TWO_SIDED|95.0|0.89|6.53||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||6.53|0.89|0.0839
72358436|NCT03192176|144229983|SUPERIORITY||Odds Ratio (OR)|3.56||||0.0191|TWO_SIDED|95.0|1.23|10.28||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||10.28|1.23|0.0191
72358437|NCT03192176|144229983|SUPERIORITY||Odds Ratio (OR)|12.11||||0.0019|TWO_SIDED|95.0|2.52|58.22||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||58.22|2.52|0.0019
72358438|NCT03192176|144229983|SUPERIORITY||Odds Ratio (OR)|2.76||||0.0593|TWO_SIDED|95.0|0.96|7.9||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||7.90|0.96|0.0593
72358439|NCT03192176|144229983|SUPERIORITY||Odds Ratio (OR)|4.95||||0.0048|TWO_SIDED|95.0|1.63|15.04||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||15.04|1.63|0.0048
72358440|NCT03192176|144229983|SUPERIORITY||Odds Ratio (OR)|2.75||||0.0494|TWO_SIDED|95.0|1.0|7.57||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||7.57|1.00|0.0494
72358441|NCT03192176|144229983|SUPERIORITY||Odds Ratio (OR)|2.15||||0.1887|TWO_SIDED|95.0|0.69|6.7||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||6.70|0.69|0.1887
72358442|NCT03192176|144229983|SUPERIORITY||Odds Ratio (OR)|3.06||||0.0717|TWO_SIDED|95.0|0.91|10.7||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||10.7|0.91|0.0717
72358443|NCT03192176|144229983|SUPERIORITY||Odds Ratio (OR)|2.43||||0.1419|TWO_SIDED|95.0|0.74|7.92||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||7.92|0.74|0.1419
72358444|NCT03192176|144229983|SUPERIORITY|0.0141|Odds Ratio (OR)|14.37||||0.0141|TWO_SIDED|95.0|1.71|120.6||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||120.6|1.71|0.0141
72358445|NCT03192176|144229983|SUPERIORITY||Odds Ratio (OR)|3.19||||0.0775|TWO_SIDED|95.0|0.88|11.54||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||11.54|0.88|0.0775
72358446|NCT03192176|144229983|SUPERIORITY||Odds Ratio (OR)|4.35||||0.0283|TWO_SIDED|95.0|1.17|16.19||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||16.19|1.17|0.0283
72358447|NCT03192176|144229983|SUPERIORITY||Odds Ratio (OR)|2.21||||0.1767|TWO_SIDED|95.0|0.7|6.96||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||6.96|0.70|0.1767
72358448|NCT03192176|144229983|SUPERIORITY||Odds Ratio (OR)|2.2||||0.1675|TWO_SIDED|95.0|0.72|6.72||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||6.72|0.72|0.1675
72358449|NCT03192176|144229983|SUPERIORITY||Odds Ratio (OR)|1.84||||0.2717|TWO_SIDED|95.0|0.62|5.49||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||5.49|0.62|0.2717
72358450|NCT03192176|144229983|SUPERIORITY||Odds Ratio (OR)|2.4||||0.1367|TWO_SIDED|95.0|0.76|7.64||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||7.64|0.76|0.1367
72429345|NCT01154036|144369671|SUPERIORITY_OR_OTHER_LEGACY||Difference in M-estimates|-6.9|||<|0.001|TWO_SIDED|95.0|-11.0|-2.8|||Multiple Imputation Robust Regression|M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values||||-2.8|-11.0|<0.001
72358451|NCT03192176|144229983|SUPERIORITY||Odds Ratio (OR)|13.53||||0.0162|TWO_SIDED|95.0|1.62|113.0||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||113.0|1.62|0.0162
72358452|NCT03192176|144229983|SUPERIORITY||Odds Ratio (OR)|3.23||||0.0765|TWO_SIDED|95.0|0.88|11.78||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||11.78|0.88|0.0765
72358453|NCT03192176|144229983|SUPERIORITY||Odds Ratio (OR)|7.8||||0.0061|TWO_SIDED|95.0|1.79|33.87||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||33.87|1.79|0.0061
72358454|NCT03192176|144229983|SUPERIORITY||Odds Ratio (OR)|5.4||||0.0181|TWO_SIDED|95.0|1.33|21.85||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||21.85|1.33|0.0181
72358455|NCT03192176|144229983|SUPERIORITY||Odds Ratio (OR)|1.63||||0.3925|TWO_SIDED|95.0|0.53|4.99||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||4.99|0.53|0.3925
72358456|NCT03192176|144229983|SUPERIORITY||Odds Ratio (OR)|1.66||||0.374|TWO_SIDED|95.0|0.54|5.12||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||5.12|0.54|0.3740
72358457|NCT03192176|144229983|SUPERIORITY||Odds Ratio (OR)|2.33||||0.1753|TWO_SIDED|95.0|0.69|7.93||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||7.93|0.69|0.1753
72358458|NCT03192176|144229983|SUPERIORITY||Odds Ratio (OR)|12.85||||0.0195|TWO_SIDED|95.0|1.51|109.5||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||109.5|1.51|0.0195
72358459|NCT03192176|144229983|SUPERIORITY||Odds Ratio (OR)|2.29||||0.1932|TWO_SIDED|95.0|0.66|8.02||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||8.02|0.66|0.1932
72358460|NCT03192176|144229983|SUPERIORITY||Odds Ratio (OR)|3.55||||0.0537|TWO_SIDED|95.0|0.98|12.86||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||12.86|0.98|0.0537
72358461|NCT03192176|144229983|SUPERIORITY||Odds Ratio (OR)|7.72||||0.0144|TWO_SIDED|95.0|1.5|39.66||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||39.66|1.50|0.0144
72358462|NCT03192176|144229983|SUPERIORITY||Odds Ratio (OR)|1.29||||0.666|TWO_SIDED|95.0|0.41|4.09||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||4.09|0.41|0.6660
72358463|NCT03192176|144229983|SUPERIORITY||Odds Ratio (OR)|1.16||||0.7923|TWO_SIDED|95.0|0.37|3.62||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||3.62|0.37|0.7923
72358464|NCT03192176|144229983|SUPERIORITY||Odds Ratio (OR)|1.73||||0.3796|TWO_SIDED|95.0|0.51|5.9||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||5.90|0.51|0.3796
72358465|NCT03192176|144229983|SUPERIORITY||Odds Ratio (OR)|4.2||||0.0874|TWO_SIDED|95.0|0.81|21.73||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||21.73|0.81|0.0874
72358466|NCT03192176|144229983|SUPERIORITY||Odds Ratio (OR)|2.6||||0.1925|TWO_SIDED|95.0|0.62|10.96||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||10.96|0.62|0.1925
72358467|NCT03192176|144229983|SUPERIORITY||Odds Ratio (OR)|3.99||||0.0651|TWO_SIDED|95.0|0.92|17.38||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||17.38|0.92|0.0651
72358468|NCT03192176|144229983|SUPERIORITY||Odds Ratio (OR)|1.46||||0.5361|TWO_SIDED|95.0|0.44|4.81||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||4.81|0.44|0.5361
72358469|NCT03192176|144229983|SUPERIORITY||Odds Ratio (OR)|1.33||||0.6258|TWO_SIDED|95.0|0.42|4.17||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||4.17|0.42|0.6258
72358470|NCT03192176|144229983|SUPERIORITY||Odds Ratio (OR)|1.32||||0.6275|TWO_SIDED|95.0|0.43|4.06||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||4.06|0.43|0.6275
72358471|NCT03192176|144229983|SUPERIORITY||Odds Ratio (OR)|2.21||||0.2212|TWO_SIDED|95.0|0.62|7.9||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||7.90|0.62|0.2212
72358472|NCT03192176|144229983|SUPERIORITY||Odds Ratio (OR)|11.13||||0.028|TWO_SIDED|95.0|1.3|95.49||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||95.49|1.30|0.0280
72358473|NCT03192176|144229983|SUPERIORITY||Odds Ratio (OR)|4.88||||0.0589|TWO_SIDED|95.0|0.94|25.32||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||25.32|0.94|0.0589
72358474|NCT03192176|144229983|SUPERIORITY||Odds Ratio (OR)|3.63||||0.0799|TWO_SIDED|95.0|0.86|15.39||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||15.39|0.86|0.0799
72358475|NCT03192176|144229983|SUPERIORITY||Odds Ratio (OR)|2.91||||0.1112|TWO_SIDED|95.0|0.78|10.87||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||10.87|0.78|0.1112
72358476|NCT03192176|144229983|SUPERIORITY||Odds Ratio (OR)|2.76||||0.0959|TWO_SIDED|95.0|0.84|9.11||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||9.11|0.84|0.0959
72358477|NCT03192176|144229983|SUPERIORITY||Odds Ratio (OR)|1.62||||0.3886|TWO_SIDED|95.0|0.54|4.85||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||4.85|0.54|0.3886
72358478|NCT03192176|144229983|SUPERIORITY||Odds Ratio (OR)|3.0||||0.0864|TWO_SIDED|95.0|0.85|10.52||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||10.52|0.85|0.0864
72358479|NCT03192176|144229983|SUPERIORITY||Odds Ratio (OR)|14.22||||0.0145|TWO_SIDED|95.0|1.69|119.5||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||119.5|1.69|0.0145
72358480|NCT03192176|144229983|SUPERIORITY||Odds Ratio (OR)|13.08||||0.018|TWO_SIDED|95.0|1.56|110.0||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||110.0|1.56|0.0180
72358481|NCT03192176|144229983|SUPERIORITY||Odds Ratio (OR)|18.53||||0.008|TWO_SIDED|95.0|2.14|160.6||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||160.6|2.14|0.0080
72358482|NCT03192176|144229983|SUPERIORITY||Odds Ratio (OR)|5.07||||0.0236|TWO_SIDED|95.0|1.24|20.65||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||20.65|1.24|0.0236
72358483|NCT03192176|144229983|SUPERIORITY||Odds Ratio (OR)|1.59||||0.4303|TWO_SIDED|0.4303|0.5|5.07||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||5.07|0.50|0.4303
72358484|NCT03192176|144229983|SUPERIORITY||Odds Ratio (OR)|1.41||||0.5529|TWO_SIDED|95.0|0.45|4.39||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||4.39|0.45|0.5529
72358485|NCT03192176|144229983|SUPERIORITY||Odds Ratio (OR)|1.87||||0.3268|TWO_SIDED|95.0|0.53|6.55||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||6.55|0.53|0.3268
72358486|NCT03192176|144229983|SUPERIORITY||Odds Ratio (OR)|10.02||||0.0343|TWO_SIDED|95.0|1.19|84.66||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||84.66|1.19|0.0343
72358487|NCT03192176|144229983|SUPERIORITY||Odds Ratio (OR)|9.45||||0.0391|TWO_SIDED|95.0|1.12|79.82||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||79.82|1.12|0.0391
72429346|NCT01154036|144369671|SUPERIORITY_OR_OTHER_LEGACY||Difference in M-estimates|-6.4|||<|0.001|TWO_SIDED|95.0|-9.4|-3.3|||Multiple Imputation Robust Regression|M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values||||-3.3|-9.4|<0.001
72358488|NCT03192176|144229983|SUPERIORITY||Odds Ratio (OR)|13.31||||0.0187|TWO_SIDED|95.0|1.54|115.1||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||115.1|1.54|0.0187
72358489|NCT03192176|144229983|SUPERIORITY||Odds Ratio (OR)|2.6||||0.1475|TWO_SIDED|95.0|0.71|9.47||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||9.47|0.71|0.1475
72358490|NCT03192176|144229983|SUPERIORITY||Odds Ratio (OR)|2.19||||0.2161|TWO_SIDED|95.0|0.63|7.55||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||7.55|0.63|0.2161
72358491|NCT03192176|144229983|SUPERIORITY||Odds Ratio (OR)|1.79||||0.3478|TWO_SIDED|95.0|0.53|6.04||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||6.04|0.53|0.3478
72358492|NCT03192176|144229983|SUPERIORITY||Odds Ratio (OR)|2.22||||0.2269|TWO_SIDED|95.0|0.61|8.14||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||8.14|0.61|0.2269
72358493|NCT03192176|144229983|SUPERIORITY||Odds Ratio (OR)|4.66||||0.0683|TWO_SIDED|95.0|0.89|24.35||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||24.35|0.89|0.0683
72358494|NCT03192176|144229983|SUPERIORITY||Odds Ratio (OR)|7.11||||0.0228|TWO_SIDED|95.0|1.31|38.49||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||38.49|1.31|0.0228
72358495|NCT03192176|144229983|SUPERIORITY||Odds Ratio (OR)|3.95||||0.062|TWO_SIDED|95.0|0.93|16.72||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||16.72|0.93|0.0620
72358496|NCT03192176|144229983|SUPERIORITY||Odds Ratio (OR)|2.18||||0.2251|TWO_SIDED|95.0|0.62|7.67||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||7.67|0.62|0.2251
72358497|NCT03192176|144229983|SUPERIORITY||Odds Ratio (OR)|1.18||||0.7908|TWO_SIDED|95.0|0.35|3.99||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||3.99|0.35|0.7908
72358498|NCT03192176|144229983|SUPERIORITY||Odds Ratio (OR)|1.84||||0.3735|TWO_SIDED|95.0|0.48|7.06||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||7.06|0.48|0.3735
72358499|NCT03192176|144229983|SUPERIORITY||Odds Ratio (OR)|2.49||||0.1856|TWO_SIDED|95.0|0.64|9.64||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||9.64|0.64|0.1856
72358500|NCT03192176|144229983|SUPERIORITY||Odds Ratio (OR)|2.67||||0.01798|TWO_SIDED|95.0|0.64|11.2||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||11.20|0.64|0.01798
72358501|NCT03192176|144229983|SUPERIORITY||Odds Ratio (OR)|3.19||||0.1101|TWO_SIDED|95.0|0.77|13.22||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||13.22|0.77|0.1101
72358502|NCT03192176|144229983|SUPERIORITY||Odds Ratio (OR)|2.99||||0.106|TWO_SIDED|95.0|0.79|11.31||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||11.31|0.79|0.1060
72358503|NCT03192176|144229983|SUPERIORITY||Odds Ratio (OR)|1.47||||0.5258|TWO_SIDED|95.0|0.45|4.86||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||4.86|0.45|0.5258
72358504|NCT03192176|144229983|SUPERIORITY||Odds Ratio (OR)|1.1||||0.8746|TWO_SIDED|95.0|0.34|3.5||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||3.50|0.34|0.8746
72358505|NCT03192176|144229983|SUPERIORITY||Odds Ratio (OR)|0.82||||0.7434|TWO_SIDED|95.0|0.24|2.77||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||2.77|0.24|0.7434
72429347|NCT01154036|144369672|SUPERIORITY_OR_OTHER_LEGACY||Difference in M-estimates|-13.7|||<|0.001|TWO_SIDED|95.0|-18.1|-9.3|||Multiple Imputation Robust Regression|M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values||||-9.3|-18.1|<0.001
72358506|NCT03192176|144229983|SUPERIORITY||Odds Ratio (OR)|1.9||||0.3211|TWO_SIDED|95.0|0.53|6.8||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||6.80|0.53|0.3211
72358507|NCT03192176|144229983|SUPERIORITY||Odds Ratio (OR)|1.51||||0.533|TWO_SIDED|95.0|0.41|5.48||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||5.48|0.41|0.5330
72358508|NCT03192176|144229983|SUPERIORITY||Odds Ratio (OR)|3.0||||0.1119|TWO_SIDED|95.0|0.77|11.64||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||11.64|0.77|0.1119
72358509|NCT03192176|144229983|SUPERIORITY||Odds Ratio (OR)|1.76||||0.354|TWO_SIDED|95.0|0.53|5.85||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||5.85|0.53|0.3540
72358510|NCT03192176|144229983|SUPERIORITY||Odds Ratio (OR)|0.65||||0.5076|TWO_SIDED|95.0|0.19|2.29||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||2.29|0.19|0.5076
72358511|NCT03192176|144229983|SUPERIORITY||Odds Ratio (OR)|0.71||||0.5801|TWO_SIDED|95.0|0.21|2.41||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||2.41|0.21|0.5801
72358512|NCT03192176|144229983|SUPERIORITY||Odds Ratio (OR)|0.48||||0.2785|TWO_SIDED|95.0|0.13|1.82||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||1.82|0.13|0.2785
72358513|NCT03192176|144229983|SUPERIORITY||Odds Ratio (OR)|0.69||||0.5656|TWO_SIDED|95.0|0.19|2.45||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||2.45|0.19|0.5656
72358514|NCT03192176|144229983|SUPERIORITY||Odds Ratio (OR)|0.73||||0.6445|TWO_SIDED|95.0|0.19|2.81||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||2.81|0.19|0.6445
72358515|NCT03192176|144229983|SUPERIORITY||Odds Ratio (OR)|1.27||||0.7363|TWO_SIDED|95.0|0.32|4.99||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||4.99|0.32|0.7363
72358516|NCT03192176|144229983|SUPERIORITY||Odds Ratio (OR)|0.56||||0.3455|TWO_SIDED|95.0|0.17|1.86||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||1.86|0.17|0.3455
72358517|NCT03192176|144229984|SUPERIORITY||Odds Ratio (OR)|4.3||||0.0037|TWO_SIDED|95.0|1.6|11.54||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||11.54|1.60|0.0037
72358518|NCT03192176|144229984|SUPERIORITY||Odds Ratio (OR)|3.95||||0.0057|TWO_SIDED|95.0|1.49|10.48||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||10.48|1.49|0.0057
72358519|NCT03192176|144229984|SUPERIORITY||Odds Ratio (OR)|6.03||||0.0003|TWO_SIDED|95.0|2.26|16.13||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||16.13|2.26|0.0003
72358520|NCT03192176|144229984|SUPERIORITY||Odds Ratio (OR)|6.42||||0.0003|TWO_SIDED|95.0|2.37|17.39||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||17.39|2.37|0.0003
72358521|NCT03192176|144229984|SUPERIORITY||Odds Ratio (OR)|2.11||||0.141|TWO_SIDED|95.0|0.78|5.73||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||5.73|0.78|0.1410
72358522|NCT03192176|144229984|SUPERIORITY||Odds Ratio (OR)|5.85||||0.0004|TWO_SIDED|95.0|2.2|15.55||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||15.55|2.20|0.0004
72358523|NCT03192176|144229984|SUPERIORITY||Odds Ratio (OR)|5.5||||0.0006|TWO_SIDED|95.0|2.08|14.54||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||14.54|2.08|0.0006
72429348|NCT01154036|144369672|SUPERIORITY_OR_OTHER_LEGACY||Difference in M-estimates|-7.8|||<|0.001|TWO_SIDED|95.0|-11.9|-3.6|||Multiple Imputation Robust Regression|M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values||||-3.6|-11.9|<0.001
72358524|NCT03192176|144229984|SUPERIORITY||Odds Ratio (OR)|4.09||||0.0037|TWO_SIDED|95.0|1.58|10.57||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||10.57|1.58|0.0037
72358525|NCT03192176|144229984|SUPERIORITY||Odds Ratio (OR)|4.31||||0.0026|TWO_SIDED|95.0|1.67|11.16||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||11.16|1.67|0.0026
72358526|NCT03192176|144229984|SUPERIORITY||Odds Ratio (OR)|6.26||||0.0002|TWO_SIDED|95.0|2.63|16.6||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||16.60|2.63|0.0002
72358527|NCT03192176|144229984|SUPERIORITY||Odds Ratio (OR)|9.4|||<|0.0001|TWO_SIDED|95.0|3.23|27.34||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||27.34|3.23|<0.0001
72358528|NCT03192176|144229984|SUPERIORITY||Odds Ratio (OR)|2.64||||0.0431|TWO_SIDED|95.0|1.03|6.76||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||6.76|1.03|0.0431
72358529|NCT03192176|144229984|SUPERIORITY||Odds Ratio (OR)|4.4||||0.002|TWO_SIDED|95.0|1.72|11.29||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||11.29|1.72|0.0020
72358530|NCT03192176|144229984|SUPERIORITY||Odds Ratio (OR)|2.76||||0.0291|TWO_SIDED|95.0|1.11|6.86||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||6.86|1.11|0.0291
72358531|NCT03192176|144229984|SUPERIORITY||Odds Ratio (OR)|3.96||||0.0063|TWO_SIDED|95.0|1.48|10.61||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||10.61|1.48|0.0063
72358532|NCT03192176|144229984|SUPERIORITY||Odds Ratio (OR)|3.11||||0.0202|TWO_SIDED|95.0|1.19|8.11||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||8.11|1.19|0.0202
72358533|NCT03192176|144229984|SUPERIORITY||Odds Ratio (OR)|4.1||||0.0044|TWO_SIDED|95.0|1.55|10.84||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||10.84|1.55|0.0044
72358534|NCT03192176|144229984|SUPERIORITY||Odds Ratio (OR)|9.21||||0.0002|TWO_SIDED|95.0|2.89|29.38||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||29.38|2.89|0.0002
72358535|NCT03192176|144229984|SUPERIORITY||Odds Ratio (OR)|2.43||||0.0706|TWO_SIDED|95.0|0.93|6.37||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||6.37|0.93|0.0706
72358536|NCT03192176|144229984|SUPERIORITY||Odds Ratio (OR)|8.2||||0.0001|TWO_SIDED|95.0|2.79|24.08||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||24.08|2.79|0.0001
72358537|NCT03192176|144229984|SUPERIORITY||Odds Ratio (OR)|3.24||||0.0146|TWO_SIDED|95.0|1.26|8.32||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||8.32|1.26|0.0146
72358538|NCT03192176|144229984|SUPERIORITY||Odds Ratio (OR)|2.37||||0.0816|TWO_SIDED|95.0|0.9|6.24||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||6.24|0.90|0.0816
72358539|NCT03192176|144229984|SUPERIORITY||Odds Ratio (OR)|2.25||||0.093|TWO_SIDED|95.0|0.87|5.81||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||5.81|0.87|0.0930
72358540|NCT03192176|144229984|SUPERIORITY||Odds Ratio (OR)|2.81||||0.365|TWO_SIDED|95.0|1.07|7.39||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||7.39|1.07|0.365
72358541|NCT03192176|144229984|SUPERIORITY||Odds Ratio (OR)|4.93||||0.0042|TWO_SIDED|95.0|1.65|14.73||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||14.73|1.65|0.0042
72358542|NCT03192176|144229984|SUPERIORITY||Odds Ratio (OR)|2.73||||0.0488|TWO_SIDED|95.0|1.01|7.41||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||7.41|1.01|0.0488
72358543|NCT03192176|144229984|SUPERIORITY||Odds Ratio (OR)|3.85||||0.0075|TWO_SIDED|95.0|1.43|10.36||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||10.36|1.43|0.0075
72358544|NCT03192176|144229984|SUPERIORITY||Odds Ratio (OR)|2.2||||0.0984|TWO_SIDED|95.0|0.86|5.59||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||5.59|0.86|0.0984
72358545|NCT03192176|144229984|SUPERIORITY||Odds Ratio (OR)|1.89||||0.2226|TWO_SIDED|95.0|0.68|5.29||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||5.29|0.68|0.2226
72358546|NCT03192176|144229984|SUPERIORITY||Odds Ratio (OR)|2.16||||0.1467|TWO_SIDED|95.0|0.76|6.08||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||6.08|0.76|0.1467
72358547|NCT03192176|144229984|SUPERIORITY||Odds Ratio (OR)|2.74||||0.0705|TWO_SIDED|95.0|0.92|8.19||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||8.19|0.92|0.0705
72358548|NCT03192176|144229984|SUPERIORITY||Odds Ratio (OR)|26.62||||0.0025|TWO_SIDED|95.0|3.16|223.9||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||223.9|3.16|0.0025
72358549|NCT03192176|144229984|SUPERIORITY||Odds Ratio (OR)|2.75||||0.0757|TWO_SIDED|95.0|0.9|8.4||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||8.40|0.90|0.0757
72358550|NCT03192176|144229984|SUPERIORITY||Odds Ratio (OR)|5.66||||0.0045|TWO_SIDED|95.0|1.71|18.74||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||18.74|1.71|0.0045
72358551|NCT03192176|144229984|SUPERIORITY||Odds Ratio (OR)|2.63||||0.0771|TWO_SIDED|95.0|0.9|7.67||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||7.67|0.90|0.0771
72358552|NCT03192176|144229984|SUPERIORITY||Odds Ratio (OR)|2.03||||0.1856|TWO_SIDED|95.0|0.71|5.81||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||5.81|0.71|0.1856
72358553|NCT03192176|144229984|SUPERIORITY||Odds Ratio (OR)|1.31||||0.5973|TWO_SIDED|95.0|0.48|3.54||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||3.54|0.48|0.5973
72358554|NCT03192176|144229984|SUPERIORITY||Odds Ratio (OR)|2.57||||0.0935|TWO_SIDED|95.0|0.85|7.77||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||7.77|0.85|0.0935
72358555|NCT03192176|144229984|SUPERIORITY||Odds Ratio (OR)|5.52||||0.0157|TWO_SIDED|95.0|1.38|22.1||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||22.10|1.38|0.0157
72358556|NCT03192176|144229984|SUPERIORITY||Odds Ratio (OR)|2.08||||0.1963|TWO_SIDED|95.0|0.68|6.32||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||6.32|0.68|0.1963
72358557|NCT03192176|144229984|SUPERIORITY||Odds Ratio (OR)|5.31||||0.0085|TWO_SIDED|95.0|1.53|18.43||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||18.43|1.53|0.0085
72358558|NCT03192176|144229984|SUPERIORITY||Odds Ratio (OR)|2.21||||0.1433|TWO_SIDED|95.0|0.76|6.38||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||6.38|0.76|0.1433
72358559|NCT03192176|144229984|SUPERIORITY||Odds Ratio (OR)|2.17||||0.1577|TWO_SIDED|95.0|0.74|6.37||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||6.37|0.74|0.1577
72429349|NCT01154036|144369673|SUPERIORITY_OR_OTHER_LEGACY||Difference in M-estimates|-10.4|||<|0.001|TWO_SIDED|95.0|-15.8|-4.9|||Multiple Imputation Robust Regression|M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values||||-4.9|-15.8|<0.001
72358560|NCT03192176|144229984|SUPERIORITY||Odds Ratio (OR)|2.16||||0.1608|TWO_SIDED|95.0|0.74|6.34||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||6.34|0.74|0.1608
72358561|NCT03192176|144229984|SUPERIORITY||Odds Ratio (OR)|2.96||||0.0693|TWO_SIDED|95.0|0.92|9.53||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||9.53|0.92|0.0693
72358562|NCT03192176|144229984|SUPERIORITY||Odds Ratio (OR)|9.57||||0.0063|TWO_SIDED|95.0|1.89|48.39||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||48.39|1.89|0.0063
72358563|NCT03192176|144229984|SUPERIORITY||Odds Ratio (OR)|2.25||||0.1637|TWO_SIDED|95.0|0.72|7.05||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||7.05|0.72|0.1637
72358564|NCT03192176|144229984|SUPERIORITY||Odds Ratio (OR)|3.57||||0.0326|TWO_SIDED|95.0|1.11|11.47||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||11.47|1.11|0.0326
72358565|NCT03192176|144229984|SUPERIORITY||Odds Ratio (OR)|2.24||||0.1455|TWO_SIDED|95.0|0.76|6.67||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||6.67|0.76|0.1455
72358566|NCT03192176|144229984|SUPERIORITY||Odds Ratio (OR)|2.08||||0.1951|TWO_SIDED|95.0|0.69|6.32||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||6.32|0.69|0.1951
72358567|NCT03192176|144229984|SUPERIORITY||Odds Ratio (OR)|1.56||||0.4097|TWO_SIDED|95.0|0.54|4.53||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||4.53|0.54|0.4097
72358568|NCT03192176|144229984|SUPERIORITY||Odds Ratio (OR)|2.29||||0.1554|TWO_SIDED|95.0|0.73|7.22||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||7.22|0.73|0.1554
72358569|NCT03192176|144229984|SUPERIORITY||Odds Ratio (OR)|4.22||||0.044|TWO_SIDED|95.0|1.04|17.14||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||17.14|1.04|0.0440
72358570|NCT03192176|144229984|SUPERIORITY||Odds Ratio (OR)|2.23||||0.1928|TWO_SIDED|95.0|0.67|7.47||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||7.47|0.67|0.1928
72358571|NCT03192176|144229984|SUPERIORITY||Odds Ratio (OR)|4.67||||0.0222|TWO_SIDED|95.0|1.25|17.47||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||17.47|1.25|0.0222
72358572|NCT03192176|144229984|SUPERIORITY||Odds Ratio (OR)|1.58||||0.4075|TWO_SIDED|95.0|0.54|4.65||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||4.65|0.54|0.4075
72358573|NCT03192176|144229984|SUPERIORITY||Odds Ratio (OR)|1.65||||0.3659|TWO_SIDED|95.0|0.56|4.93||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||4.93|0.56|0.3659
72358574|NCT03192176|144229984|SUPERIORITY||Odds Ratio (OR)|1.15||||0.7878|TWO_SIDED|95.0|0.41|3.24||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||3.24|0.41|0.7878
72358575|NCT03192176|144229984|SUPERIORITY||Odds Ratio (OR)|3.26||||0.0635|TWO_SIDED|95.0|0.94|11.38||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||11.38|0.94|0.0635
72358576|NCT03192176|144229984|SUPERIORITY||Odds Ratio (OR)|14.62||||0.0137|TWO_SIDED|95.0|1.73|123.3||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||123.3|1.73|0.0137
72358577|NCT03192176|144229984|SUPERIORITY||Odds Ratio (OR)|2.91||||0.1069|TWO_SIDED|95.0|0.79|10.62||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||10.62|0.79|0.1069
72429350|NCT01154036|144369673|SUPERIORITY_OR_OTHER_LEGACY||Difference in M-estimates|-8.3|||<|0.001|TWO_SIDED|95.0|-12.5|-4.2|||Multiple Imputation Robust Regression|M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values||||-4.2|-12.5|<0.001
72358578|NCT03192176|144229984|SUPERIORITY||Odds Ratio (OR)|5.6||||0.0186|TWO_SIDED|95.0|1.33|23.47||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||23.47|1.33|0.0186
72358579|NCT03192176|144229984|SUPERIORITY||Odds Ratio (OR)|2.37||||0.1434|TWO_SIDED|95.0|0.75|7.56||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||7.56|0.75|0.1434
72358580|NCT03192176|144229984|SUPERIORITY||Odds Ratio (OR)|2.2||||0.167|TWO_SIDED|95.0|0.72|6.75||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||6.75|0.72|0.1670
72358581|NCT03192176|144229984|SUPERIORITY||Odds Ratio (OR)|1.16||||0.781|TWO_SIDED|95.0|0.41|3.28||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||3.28|0.41|0.7810
72358582|NCT03192176|144229984|SUPERIORITY||Odds Ratio (OR)|2.27||||0.1682|TWO_SIDED|95.0|0.71|7.26||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||7.26|0.71|0.1682
72358583|NCT03192176|144229984|SUPERIORITY||Odds Ratio (OR)|5.22||||0.0215|TWO_SIDED|95.0|1.28|21.39||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||21.39|1.28|0.0215
72358584|NCT03192176|144229984|SUPERIORITY||Odds Ratio (OR)|4.75||||0.0306|TWO_SIDED|95.0|1.16|19.52||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||19.52|1.16|0.0306
72358585|NCT03192176|144229984|SUPERIORITY||Odds Ratio (OR)|10.1||||0.0059|TWO_SIDED|95.0|1.92|52.29||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||52.29|1.92|0.0059
72358586|NCT03192176|144229984|SUPERIORITY||Odds Ratio (OR)|2.64||||0.1004|TWO_SIDED|95.0|0.83|8.43||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||8.43|0.83|0.1004
72429351|NCT01154036|144369674|SUPERIORITY_OR_OTHER_LEGACY||Difference in M-estimates|-6.3|||<|0.001|TWO_SIDED|95.0|-10.0|-2.5|||Multiple Imputation Robust Regression|M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values||||-2.5|-10.0|<0.001
72429352|NCT01154036|144369674|SUPERIORITY_OR_OTHER_LEGACY||Difference in M-estimates|-3.5||||0.052|TWO_SIDED|95.0|-7.1|0.0|||Multiple Imputation Robust Regression|M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values||||0.0|-7.1|0.052
72358587|NCT03192176|144229984|SUPERIORITY||Odds Ratio (OR)|2.11||||0.1837|TWO_SIDED|95.0|0.7|6.36||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||6.36|0.70|0.1837
72358588|NCT03192176|144229984|SUPERIORITY||Odds Ratio (OR)|1.33||||0.5929|TWO_SIDED|95.0|0.47|3.75||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||3.75|0.47|0.5929
72358589|NCT03192176|144229984|SUPERIORITY||Odds Ratio (OR)|1.93||||0.2588|TWO_SIDED|95.0|0.62|6.07||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||6.07|0.62|0.2588
72358590|NCT03192176|144229984|SUPERIORITY||Odds Ratio (OR)|7.69||||0.0129|TWO_SIDED|95.0|1.54|38.41||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||38.41|1.54|0.0129
72358591|NCT03192176|144229984|SUPERIORITY||Odds Ratio (OR)|7.12||||0.0168|TWO_SIDED|95.0|1.42|35.61||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||35.61|1.42|0.0168
72358592|NCT03192176|144229984|SUPERIORITY||Odds Ratio (OR)|9.95||||0.0058|TWO_SIDED|95.0|1.94|50.97||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||50.97|1.94|0.0058
72429353|NCT01154036|144369675|SUPERIORITY_OR_OTHER_LEGACY||Difference in M-estimates|-5.8||||0.024|TWO_SIDED|95.0|-10.8|-0.8|||Multiple Imputation Robust Regression|M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values||||-0.8|-10.8|0.024
72429354|NCT01154036|144369675|SUPERIORITY_OR_OTHER_LEGACY||Difference in M-estimates|-6.1||||0.002|TWO_SIDED|95.0|-9.9|-2.3|||Multiple Imputation Robust Regression|M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values||||-2.3|-9.9|0.002
72358593|NCT03192176|144229984|SUPERIORITY||Odds Ratio (OR)|2.08||||0.1934|TWO_SIDED|95.0|0.69|6.26||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||6.26|0.69|0.1934
72358594|NCT03192176|144229984|SUPERIORITY||Odds Ratio (OR)|2.01||||0.2181|TWO_SIDED|95.0|0.66|6.12||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||6.12|0.66|0.2181
72358595|NCT03192176|144229984|SUPERIORITY||Odds Ratio (OR)|1.58||||0.4116|TWO_SIDED|95.0|0.53|4.71||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||4.71|0.53|0.4116
72358596|NCT03192176|144229984|SUPERIORITY||Odds Ratio (OR)|2.84||||0.0938|TWO_SIDED|95.0|0.84|9.66||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||9.66|0.84|0.0938
72358597|NCT03192176|144229984|SUPERIORITY||Odds Ratio (OR)|8.02||||0.0125|TWO_SIDED|95.0|1.57|41.08||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||41.08|1.57|0.0125
72358598|NCT03192176|144229984|SUPERIORITY||Odds Ratio (OR)|3.29||||0.0761|TWO_SIDED|95.0|0.88|12.23||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||12.23|0.88|0.0761
72358599|NCT03192176|144229984|SUPERIORITY||Odds Ratio (OR)|4.02||||0.0305|TWO_SIDED|95.0|1.14|14.16||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||14.16|1.14|0.0305
72358600|NCT03192176|144229984|SUPERIORITY||Odds Ratio (OR)|3.42||||0.0501|TWO_SIDED|95.0|1.0|11.68||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||11.68|1.00|0.0501
72358601|NCT03192176|144229984|SUPERIORITY||Odds Ratio (OR)|2.61||||0.1212|TWO_SIDED|95.0|0.78|8.77||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||8.77|0.78|0.1212
72358602|NCT03192176|144229984|SUPERIORITY||Odds Ratio (OR)|1.13||||0.8332|TWO_SIDED|95.0|0.35|3.68||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||3.68|0.35|0.8332
72358603|NCT03192176|144229984|SUPERIORITY||Odds Ratio (OR)|1.66||||0.4285|TWO_SIDED|95.0|0.48|5.76||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||5.76|0.48|0.4285
72358604|NCT03192176|144229984|SUPERIORITY||Odds Ratio (OR)|2.98||||0.0954|TWO_SIDED|95.0|0.83|10.74||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||10.74|0.83|0.0954
72358605|NCT03192176|144229984|SUPERIORITY||Odds Ratio (OR)|2.98||||0.111|TWO_SIDED|95.0|0.78|11.38||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||11.38|0.78|0.1110
72358606|NCT03192176|144229984|SUPERIORITY||Odds Ratio (OR)|2.44||||0.1642|TWO_SIDED|95.0|0.69|8.55||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||8.55|0.69|0.1642
72358607|NCT03192176|144229984|SUPERIORITY||Odds Ratio (OR)|2.19||||0.1976|TWO_SIDED|95.0|0.66|7.24||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||7.24|0.66|0.1976
72358608|NCT03192176|144229984|SUPERIORITY||Odds Ratio (OR)|1.4||||0.5761|TWO_SIDED|95.0|0.43|4.58||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||4.58|0.43|0.5761
72358609|NCT03192176|144229984|SUPERIORITY||Odds Ratio (OR)|0.64||||0.454|TWO_SIDED|95.0|0.2|2.04||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||2.04|0.20|0.4540
72358610|NCT03192176|144229984|SUPERIORITY||Odds Ratio (OR)|0.57||||0.3732|TWO_SIDED|95.0|0.17|1.96||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||1.96|0.17|0.3732
72429355|NCT01154036|144369676|SUPERIORITY_OR_OTHER_LEGACY||Difference in M-estimates|-10.6|||<|0.001|TWO_SIDED|95.0|-14.9|-6.4|||Multiple Imputation Robust Regression|M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values||||-6.4|-14.9|<0.001
72358611|NCT03192176|144229984|SUPERIORITY||Odds Ratio (OR)|1.59||||0.4665|TWO_SIDED|95.0|0.46|5.5||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||5.50|0.46|0.4665
72358612|NCT03192176|144229984|SUPERIORITY||Odds Ratio (OR)|1.46||||0.5634|TWO_SIDED|95.0|0.41|5.25||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||5.25|0.41|0.5634
72358613|NCT03192176|144229984|SUPERIORITY||Odds Ratio (OR)|1.65||||0.4297|TWO_SIDED|95.0|0.48|5.7||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||5.70|0.48|0.4297
72358614|NCT03192176|144229984|SUPERIORITY||Odds Ratio (OR)|0.98||||0.9789|TWO_SIDED|95.0|0.31|3.14||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||3.14|0.31|0.9789
72358615|NCT03192176|144229984|SUPERIORITY||Odds Ratio (OR)|0.81||||0.7357|TWO_SIDED|95.0|0.24|2.7||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||2.70|0.24|0.7357
72358616|NCT03192176|144229984|SUPERIORITY||Odds Ratio (OR)|0.46||||0.1977|TWO_SIDED|95.0|0.14|1.5||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||1.50|0.14|0.1977
72358617|NCT03192176|144229984|SUPERIORITY||Odds Ratio (OR)|0.52||||0.3203|TWO_SIDED|95.0|0.14|1.88||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||1.88|0.14|0.3203
72358618|NCT03192176|144229984|SUPERIORITY||Odds Ratio (OR)|1.02||||0.9739|TWO_SIDED|95.0|0.3|3.44||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||3.44|0.30|0.9739
72358619|NCT03192176|144229984|SUPERIORITY||Odds Ratio (OR)|1.33||||0.6714|TWO_SIDED|95.0|0.36|4.97||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||4.97|0.36|0.6714
72358620|NCT03192176|144229984|SUPERIORITY||Odds Ratio (OR)|0.75||||0.6375|TWO_SIDED|95.0|0.22|2.52||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||2.52|0.22|0.6375
72358621|NCT03192176|144229984|SUPERIORITY||Odds Ratio (OR)|0.54||||0.298|TWO_SIDED|95.0|0.17|1.71||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||1.71|0.17|0.2980
72358622|NCT03192176|144229985|SUPERIORITY||Odds Ratio (OR)|5.35||||0.0044|TWO_SIDED|95.0|1.69|16.96||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||16.96|1.69|0.0044
72358623|NCT03192176|144229985|SUPERIORITY||Odds Ratio (OR)|8.65||||0.0002|TWO_SIDED|95.0|2.79|26.83||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||26.83|2.79|0.0002
72358624|NCT03192176|144229985|SUPERIORITY||Odds Ratio (OR)|10.82|||<|0.0001|TWO_SIDED|95.0|3.49|33.54||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||33.54|3.49|<0.0001
72358625|NCT03192176|144229985|SUPERIORITY||Odds Ratio (OR)|10.01|||<|0.0001|TWO_SIDED|95.0|3.2|31.29||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||31.29|3.20|<0.0001
72358626|NCT03192176|144229985|SUPERIORITY||Odds Ratio (OR)|2.51||||0.1266|TWO_SIDED|95.0|0.77|8.15||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||8.15|0.77|0.1266
72358627|NCT03192176|144229985|SUPERIORITY||Odds Ratio (OR)|5.72||||0.0024|TWO_SIDED|95.0|1.85|17.66||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||17.66|1.85|0.0024
72358628|NCT03192176|144229985|SUPERIORITY||Odds Ratio (OR)|7.93||||0.0003|TWO_SIDED|95.0|2.59|24.26||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||24.26|2.59|0.0003
72429356|NCT01154036|144369676|SUPERIORITY_OR_OTHER_LEGACY||Difference in M-estimates|-6.2||||0.002|TWO_SIDED|95.0|-10.2|-2.2|||Multiple Imputation Robust Regression|M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values||||-2.2|-10.2|0.002
72358629|NCT03192176|144229985|SUPERIORITY||Odds Ratio (OR)|3.11||||0.0217|TWO_SIDED|95.0|1.18|8.17||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||8.17|1.18|0.0217
72358630|NCT03192176|144229985|SUPERIORITY||Odds Ratio (OR)|4.63||||0.0021|TWO_SIDED|95.0|1.75|12.25||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||12.25|1.75|0.0021
72358631|NCT03192176|144229985|SUPERIORITY||Odds Ratio (OR)|4.72||||0.0016|TWO_SIDED|95.0|1.8|12.37||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||12.37|1.80|0.0016
72358632|NCT03192176|144229985|SUPERIORITY||Odds Ratio (OR)|4.8||||0.0018|TWO_SIDED|95.0|1.79|12.86||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||12.86|1.79|0.0018
72358633|NCT03192176|144229985|SUPERIORITY||Odds Ratio (OR)|2.69||||0.0467|TWO_SIDED|95.0|1.01|7.14||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||7.14|1.01|0.0467
72358634|NCT03192176|144229985|SUPERIORITY||Odds Ratio (OR)|4.7||||0.0016|TWO_SIDED|95.0|1.8|12.28||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||12.28|1.80|0.0016
72358635|NCT03192176|144229985|SUPERIORITY||Odds Ratio (OR)|2.98||||0.0234|TWO_SIDED|95.0|1.16|7.65||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||7.65|1.16|0.0234
72358636|NCT03192176|144229985|SUPERIORITY||Odds Ratio (OR)|2.88||||0.0294|TWO_SIDED|95.0|1.11|7.46||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||7.46|1.11|0.0294
72358637|NCT03192176|144229985|SUPERIORITY||Odds Ratio (OR)|3.74||||0.0068|TWO_SIDED|95.0|1.44|9.73||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||9.73|1.44|0.0068
72358638|NCT03192176|144229985|SUPERIORITY||Odds Ratio (OR)|4.35||||0.0025|TWO_SIDED|95.0|1.68|11.29||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||11.29|1.68|0.0025
72358639|NCT03192176|144229985|SUPERIORITY||Odds Ratio (OR)|5.82||||0.0006|TWO_SIDED|95.0|2.13|15.92||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||15.92|2.13|0.0006
72358640|NCT03192176|144229985|SUPERIORITY||Odds Ratio (OR)|2.53||||0.0572|TWO_SIDED|95.0|0.97|6.61||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||6.61|0.97|0.0572
72358641|NCT03192176|144229985|SUPERIORITY||Odds Ratio (OR)|6.03||||0.0003|TWO_SIDED|95.0|2.28|15.97||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||15.97|2.28|0.0003
72358642|NCT03192176|144229985|SUPERIORITY||Odds Ratio (OR)|2.55||||0.046|TWO_SIDED|95.0|1.02|6.38||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||6.38|1.02|0.0460
72358643|NCT03192176|144229985|SUPERIORITY||Odds Ratio (OR)|2.03||||0.1406|TWO_SIDED|95.0|0.79|5.23||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||5.23|0.79|0.1406
72358644|NCT03192176|144229985|SUPERIORITY||Odds Ratio (OR)|2.97||||0.0234|TWO_SIDED|95.0|1.16|7.63||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||7.63|1.16|0.0234
72358645|NCT03192176|144229985|SUPERIORITY||Odds Ratio (OR)|2.82||||0.0302|TWO_SIDED|95.0|1.1|7.22||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||7.22|1.10|0.0302
72358646|NCT03192176|144229985|SUPERIORITY||Odds Ratio (OR)|5.23||||0.0016|TWO_SIDED|95.0|1.87|14.63||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||14.63|1.87|0.0016
72358647|NCT03192176|144229985|SUPERIORITY||Odds Ratio (OR)|1.82||||0.2105|TWO_SIDED|95.0|0.71|4.64||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||4.64|0.71|0.2105
72358648|NCT03192176|144229985|SUPERIORITY||Odds Ratio (OR)|4.17||||0.0033|TWO_SIDED|95.0|1.61|10.81||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||10.81|1.61|0.0033
72358649|NCT03192176|144229985|SUPERIORITY||Odds Ratio (OR)|2.1||||0.1087|TWO_SIDED|95.0|0.85|5.21||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||5.21|0.85|0.1087
72358650|NCT03192176|144229985|SUPERIORITY||Odds Ratio (OR)|1.56||||0.36|TWO_SIDED|95.0|0.6|4.03||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||4.03|0.60|0.3600
72358651|NCT03192176|144229985|SUPERIORITY||Odds Ratio (OR)|2.05||||0.1394|TWO_SIDED|95.0|0.79|5.32||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||5.32|0.79|0.1394
72358652|NCT03192176|144229985|SUPERIORITY||Odds Ratio (OR)|2.7||||0.0522|TWO_SIDED|95.0|0.99|7.36||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||7.36|0.99|0.0522
72358653|NCT03192176|144229985|SUPERIORITY||Odds Ratio (OR)|3.97||||0.0119|TWO_SIDED|95.0|1.63|11.61||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||11.61|1.63|0.0119
72358654|NCT03192176|144229985|SUPERIORITY||Odds Ratio (OR)|2.07||||0.1474|TWO_SIDED|95.0|0.77|5.53||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||5.53|0.77|0.1474
72358655|NCT03192176|144229985|SUPERIORITY||Odds Ratio (OR)|5.08||||0.0026|TWO_SIDED|95.0|1.76|14.67||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||14.67|1.76|0.0026
72358656|NCT03192176|144229985|SUPERIORITY||Odds Ratio (OR)|2.11||||0.1263|TWO_SIDED|95.0|0.81|5.51||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||5.51|0.81|0.1263
72358657|NCT03192176|144229985|SUPERIORITY||Odds Ratio (OR)|1.83||||0.2327|TWO_SIDED|95.0|0.68|4.95||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||4.95|0.68|0.2327
72358658|NCT03192176|144229985|SUPERIORITY||Odds Ratio (OR)|2.12||||0.1359|TWO_SIDED|95.0|0.79|5.7||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||5.70|0.79|0.1359
72358659|NCT03192176|144229985|SUPERIORITY||Odds Ratio (OR)|3.35||||0.0258|TWO_SIDED|95.0|1.16|9.69||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||9.69|1.16|0.0258
72358660|NCT03192176|144229985|SUPERIORITY||Odds Ratio (OR)|4.77||||0.0076|TWO_SIDED|95.0|1.51|15.04||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||15.04|1.51|0.0076
72358661|NCT03192176|144229985|SUPERIORITY||Odds Ratio (OR)|2.36||||0.1088|TWO_SIDED|95.0|0.83|6.75||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||6.75|0.83|0.1088
72358662|NCT03192176|144229985|SUPERIORITY||Odds Ratio (OR)|4.89||||0.0045|TWO_SIDED|95.0|1.64|14.62||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||14.62|1.64|0.0045
72358663|NCT03192176|144229985|SUPERIORITY||Odds Ratio (OR)|2.74||||0.0493|TWO_SIDED|95.0|1.0|7.5||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||7.50|1.00|0.0493
72358664|NCT03192176|144229985|SUPERIORITY||Odds Ratio (OR)|2.99||||0.0376|TWO_SIDED|95.0|1.06|8.41||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||8.41|1.06|0.0376
72429357|NCT01154036|144369677|SUPERIORITY_OR_OTHER_LEGACY||Difference in M-estimates|-9.3|||<|0.001|TWO_SIDED|95.0|-14.8|-3.9|||Multiple Imputation Robust Regression|M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values||||-3.9|-14.8|<0.001
72358665|NCT03192176|144229985|SUPERIORITY||Odds Ratio (OR)|2.53||||0.0723|TWO_SIDED|95.0|0.92|6.94||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||6.94|0.92|0.0723
72358666|NCT03192176|144229985|SUPERIORITY||Odds Ratio (OR)|3.11||||0.0396|TWO_SIDED|95.0|1.06|9.17||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||9.17|1.06|0.0396
72358667|NCT03192176|144229985|SUPERIORITY||Odds Ratio (OR)|6.18||||0.0031|TWO_SIDED|95.0|1.85|20.67||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||20.67|1.85|0.0031
72358668|NCT03192176|144229985|SUPERIORITY||Odds Ratio (OR)|2.41||||0.1044|TWO_SIDED|95.0|0.83|6.96||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||6.96|0.83|0.1044
72358669|NCT03192176|144229985|SUPERIORITY||Odds Ratio (OR)|5.47||||0.0029|TWO_SIDED|95.0|1.78|16.75||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||16.75|1.78|0.0029
72358670|NCT03192176|144229985|SUPERIORITY||Odds Ratio (OR)|3.01||||0.0364|TWO_SIDED|95.0|1.07|8.45||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||8.45|1.07|0.0364
72358671|NCT03192176|144229985|SUPERIORITY||Odds Ratio (OR)|1.26||||0.6396|TWO_SIDED|95.0|0.47|3.37||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||3.37|0.47|0.6396
72358672|NCT03192176|144229985|SUPERIORITY||Odds Ratio (OR)|1.47||||0.4378|TWO_SIDED|95.0|0.55|3.91||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||3.91|0.55|0.4378
72358673|NCT03192176|144229985|SUPERIORITY||Odds Ratio (OR)|1.95||||0.2045|TWO_SIDED|95.0|0.7|5.44||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||5.44|0.70|0.2045
72358674|NCT03192176|144229985|SUPERIORITY||Odds Ratio (OR)|2.54||||0.0958|TWO_SIDED|95.0|0.85|7.62||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||7.62|0.85|0.0958
72358675|NCT03192176|144229985|SUPERIORITY||Odds Ratio (OR)|1.7||||0.321|TWO_SIDED|95.0|0.6|4.85||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||4.85|0.60|0.3210
72358676|NCT03192176|144229985|SUPERIORITY||Odds Ratio (OR)|3.75||||0.0199|TWO_SIDED|95.0|1.23|11.39||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||11.39|1.23|0.0199
72358677|NCT03192176|144229985|SUPERIORITY||Odds Ratio (OR)|2.26||||0.1219|TWO_SIDED|95.0|0.8|6.36||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||6.36|0.80|0.1219
72358678|NCT03192176|144229985|SUPERIORITY||Odds Ratio (OR)|1.72||||0.2975|TWO_SIDED|95.0|0.62|4.76||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||4.76|0.62|0.2975
72358679|NCT03192176|144229985|SUPERIORITY||Odds Ratio (OR)|1.75||||0.2763|TWO_SIDED|95.0|0.64|4.8||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||4.80|0.64|0.2763
72358680|NCT03192176|144229985|SUPERIORITY||Odds Ratio (OR)|2.33||||0.1235|TWO_SIDED|95.0|0.79|6.82||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||6.82|0.79|0.1235
72358681|NCT03192176|144229985|SUPERIORITY||Odds Ratio (OR)|4.24||||0.019|TWO_SIDED|95.0|1.27|14.19||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||14.19|1.27|0.0190
72358682|NCT03192176|144229985|SUPERIORITY||Odds Ratio (OR)|1.98||||0.2213|TWO_SIDED|95.0|0.66|5.93||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||5.93|0.66|0.2213
72429358|NCT01154036|144369677|SUPERIORITY_OR_OTHER_LEGACY||Difference in M-estimates|-8.4|||<|0.001|TWO_SIDED|95.0|-12.6|-4.2|||Multiple Imputation Robust Regression|M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values||||-4.2|-12.6|<0.001
72358683|NCT03192176|144229985|SUPERIORITY||Odds Ratio (OR)|5.88||||0.005|TWO_SIDED|95.0|1.71|20.25||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||20.25|1.71|0.0050
72358684|NCT03192176|144229985|SUPERIORITY||Odds Ratio (OR)|2.39||||0.1053|TWO_SIDED|95.0|0.83|6.85||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||6.85|0.83|0.1053
72358685|NCT03192176|144229985|SUPERIORITY||Odds Ratio (OR)|2.39||||0.0991|TWO_SIDED|95.0|0.85|6.72||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||6.72|0.85|0.0991
72358686|NCT03192176|144229985|SUPERIORITY||Odds Ratio (OR)|1.93||||0.2056|TWO_SIDED|95.0|0.7|5.32||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||5.32|0.70|0.2056
72358687|NCT03192176|144229985|SUPERIORITY||Odds Ratio (OR)|3.17||||0.0407|TWO_SIDED|95.0|1.05|9.57||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||9.57|1.05|0.0407
72358688|NCT03192176|144229985|SUPERIORITY||Odds Ratio (OR)|5.47||||0.0059|TWO_SIDED|95.0|1.63|18.3||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||18.30|1.63|0.0059
72358689|NCT03192176|144229985|SUPERIORITY||Odds Ratio (OR)|3.85||||0.023|TWO_SIDED|95.0|1.2|12.3||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||12.30|1.20|0.0230
72358690|NCT03192176|144229985|SUPERIORITY||Odds Ratio (OR)|7.36||||0.0015|TWO_SIDED|95.0|2.14|25.29||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||25.29|2.14|0.0015
72358691|NCT03192176|144229985|SUPERIORITY||Odds Ratio (OR)|3.45||||0.0248|TWO_SIDED|95.0|1.17|10.16||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||10.16|1.17|0.0248
72358692|NCT03192176|144229985|SUPERIORITY||Odds Ratio (OR)|2.37||||0.1091|TWO_SIDED|95.0|0.82|6.83||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||6.83|0.82|0.1091
72358693|NCT03192176|144229985|SUPERIORITY||Odds Ratio (OR)|1.71||||0.3054|TWO_SIDED|95.0|0.61|4.75||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||4.75|0.61|0.3054
72358694|NCT03192176|144229985|SUPERIORITY||Odds Ratio (OR)|2.48||||0.1129|TWO_SIDED|95.0|0.81|7.61||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||7.61|0.81|0.1129
72358695|NCT03192176|144229985|SUPERIORITY||Odds Ratio (OR)|3.28||||0.0432|TWO_SIDED|95.0|1.04|10.37||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||10.37|1.04|0.0432
72358696|NCT03192176|144229985|SUPERIORITY||Odds Ratio (OR)|3.77||||0.0315|TWO_SIDED|95.0|1.13|12.6||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||12.60|1.13|0.0315
72358697|NCT03192176|144229985|SUPERIORITY||Odds Ratio (OR)|4.26||||0.0147|TWO_SIDED|95.0|1.33|13.64||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||13.64|1.33|0.0147
72358698|NCT03192176|144229985|SUPERIORITY||Odds Ratio (OR)|3.18||||0.0405|TWO_SIDED|95.0|1.05|9.59||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||9.59|1.05|0.0405
72358699|NCT03192176|144229985|SUPERIORITY||Odds Ratio (OR)|1.4||||0.5238|TWO_SIDED|95.0|0.5|3.93||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||3.93|0.50|0.5238
72358700|NCT03192176|144229985|SUPERIORITY||Odds Ratio (OR)|1.73||||0.306|TWO_SIDED|95.0|0.6|4.97||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||4.97|0.60|0.3060
72358701|NCT03192176|144229985|SUPERIORITY||Odds Ratio (OR)|1.64||||0.3747|TWO_SIDED|95.0|0.55|4.86||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||4.86|0.55|0.3747
72358702|NCT03192176|144229985|SUPERIORITY||Odds Ratio (OR)|3.49||||0.0443|TWO_SIDED|95.0|1.03|11.8||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||11.80|1.03|0.0443
72358703|NCT03192176|144229985|SUPERIORITY||Odds Ratio (OR)|2.49||||0.1269|TWO_SIDED|95.0|0.77|8.06||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||8.06|0.77|0.1269
72358704|NCT03192176|144229985|SUPERIORITY||Odds Ratio (OR)|5.15||||0.0095|TWO_SIDED|95.0|1.49|17.13||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||17.13|1.49|0.0095
72358705|NCT03192176|144229985|SUPERIORITY||Odds Ratio (OR)|2.34||||0.1254|TWO_SIDED|95.0|0.79|6.94||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||6.94|0.79|0.1254
72358706|NCT03192176|144229985|SUPERIORITY||Odds Ratio (OR)|3.66||||0.0402|TWO_SIDED|95.0|1.06|12.63||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||12.63|1.06|0.0402
72358707|NCT03192176|144229985|SUPERIORITY||Odds Ratio (OR)|1.59||||0.4547|TWO_SIDED|95.0|0.47|5.42||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||5.42|0.47|0.4547
72358708|NCT03192176|144229985|SUPERIORITY||Odds Ratio (OR)|1.71||||0.4008|TWO_SIDED|95.0|0.49|5.99||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||5.99|0.49|0.4008
72358709|NCT03192176|144229985|SUPERIORITY||Odds Ratio (OR)|2.55||||0.1535|TWO_SIDED|95.0|0.71|9.22||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||9.22|0.71|0.1535
72358710|NCT03192176|144229985|SUPERIORITY||Odds Ratio (OR)|7.19||||0.0055|TWO_SIDED|95.0|1.79|28.95||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||28.95|1.79|0.0055
72358711|NCT03192176|144229985|SUPERIORITY||Odds Ratio (OR)|2.19||||0.2116|TWO_SIDED|95.0|0.64|7.5||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||7.50|0.64|0.2116
72358712|NCT03192176|144229985|SUPERIORITY||Odds Ratio (OR)|2.34||||0.1668|TWO_SIDED|95.0|0.7|7.83||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||7.83|0.70|0.1668
72358713|NCT03192176|144229985|SUPERIORITY||Odds Ratio (OR)|2.32||||0.1824|TWO_SIDED|95.0|0.67|7.98||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||7.98|0.67|0.1824
72358714|NCT03192176|144229985|SUPERIORITY||Odds Ratio (OR)|0.85||||0.797|TWO_SIDED|95.0|0.25|2.9||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||2.90|0.25|0.7970
72358715|NCT03192176|144229985|SUPERIORITY||Odds Ratio (OR)|0.78||||0.7065|TWO_SIDED|95.0|0.21|2.85||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||2.85|0.21|0.7065
72358716|NCT03192176|144229985|SUPERIORITY||Odds Ratio (OR)|1.08||||0.9126|TWO_SIDED|95.0|0.29|3.93||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||3.93|0.29|0.9126
72358717|NCT03192176|144229985|SUPERIORITY||Odds Ratio (OR)|2.82||||0.1282|TWO_SIDED|95.0|0.74|10.7||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||10.70|0.74|0.1282
72358718|NCT03192176|144229985|SUPERIORITY||Odds Ratio (OR)|2.03||||0.2661|TWO_SIDED|95.0|0.58|7.04||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||7.04|0.58|0.2661
72429359|NCT01154036|144369678|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least-squares Means|-3.9||||0.613|TWO_SIDED|95.0|-18.9|11.1|||Constrained Longitudinal Data Analysis|Geometric mean percent changes from baseline were calculated based on back-transformation via exponentiation of the model-based least square means||||11.1|-18.9|0.613
72358719|NCT03192176|144229985|SUPERIORITY||Odds Ratio (OR)|1.22||||0.7457|TWO_SIDED|95.0|0.36|4.09||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||4.09|0.36|0.7457
72358720|NCT03192176|144229985|SUPERIORITY||Odds Ratio (OR)|1.73||||0.4095|TWO_SIDED|95.0|0.47|6.41||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||6.41|0.47|0.4095
72358721|NCT03192176|144229985|SUPERIORITY||Odds Ratio (OR)|1.04||||0.9571|TWO_SIDED|95.0|0.28|3.77||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||3.77|0.28|0.9571
72358722|NCT03192176|144229985|SUPERIORITY||Odds Ratio (OR)|0.9||||0.8827|TWO_SIDED|95.0|0.23|3.59||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||3.59|0.23|0.8827
72358723|NCT03192176|144229985|SUPERIORITY||Odds Ratio (OR)|0.69||||0.5944|TWO_SIDED|95.0|0.17|2.74||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||2.74|0.17|0.5944
72358724|NCT03192176|144229985|SUPERIORITY||Odds Ratio (OR)|2.74||||0.1647|TWO_SIDED|95.0|0.66|11.39||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||11.39|0.66|0.1647
72358725|NCT03192176|144229985|SUPERIORITY||Odds Ratio (OR)|2.07||||0.2684|TWO_SIDED|95.0|0.57|7.48||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||7.48|0.57|0.2684
72358726|NCT03192176|144229985|SUPERIORITY||Odds Ratio (OR)|1.48||||0.5338|TWO_SIDED|95.0|0.43|5.07||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||5.07|0.43|0.5338
72358727|NCT03192176|144229986|SUPERIORITY||LSMean difference|-1.1|STANDARD_ERROR_OF_MEAN|0.45||0.0179|TWO_SIDED|95.0|-1.95|-0.18||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors and baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|Mixed model repeated measures (MMRM)|||Week 4||-0.18|-1.95|0.0179
72358728|NCT03192176|144229986|SUPERIORITY||LSMean difference|-1.4|STANDARD_ERROR_OF_MEAN|0.45||0.0027|TWO_SIDED|95.0|-2.25|-0.47||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors and baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4||-0.47|-2.25|0.0027
72358729|NCT03192176|144229986|SUPERIORITY||LSMean difference|-1.6|STANDARD_ERROR_OF_MEAN|0.45||0.0004|TWO_SIDED|95.0|-2.5|-0.73||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors and baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4||-0.73|-2.50|0.0004
72358730|NCT03192176|144229986|SUPERIORITY||LSMean difference|-1.5|STANDARD_ERROR_OF_MEAN|0.46||0.0009|TWO_SIDED|95.0|-2.43|-0.64||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors and baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4||-0.64|-2.43|0.0009
72358731|NCT03192176|144229986|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.45||0.5806|TWO_SIDED|95.0|-1.14|0.64||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors and baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4||0.64|-1.14|0.5806
72358732|NCT03192176|144229986|SUPERIORITY||LSMean difference|-1.2|STANDARD_ERROR_OF_MEAN|0.45||0.0105|TWO_SIDED|95.0|-2.03|-0.27||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors and baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4||-0.27|-2.03|0.0105
72358733|NCT03192176|144229986|SUPERIORITY||LSMean difference|-1.3|STANDARD_ERROR_OF_MEAN|0.45||0.0048|TWO_SIDED|95.0|-2.16|-0.39||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors and baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4||-0.39|-2.16|0.0048
72358734|NCT03192176|144229986|SUPERIORITY||LSMean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.46||0.1801|TWO_SIDED|95.0|-1.52|0.29||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors and baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8||0.29|-1.52|0.1801
72358735|NCT03192176|144229986|SUPERIORITY||LSMean difference|-0.9|STANDARD_ERROR_OF_MEAN|0.46||0.0609|TWO_SIDED|95.0|-1.76|0.04||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors and baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8||0.04|-1.76|0.0609
72358736|NCT03192176|144229986|SUPERIORITY||LSMean difference|-1.4|STANDARD_ERROR_OF_MEAN|0.47||0.0028|TWO_SIDED|95.0|-2.33|-0.49||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors and baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8||-0.49|-2.33|0.0028
72358737|NCT03192176|144229986|SUPERIORITY||LSMean difference|-1.5|STANDARD_ERROR_OF_MEAN|0.47||0.0018|TWO_SIDED|95.0|-2.4|-0.55||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors and baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8||-0.55|-2.40|0.0018
72358738|NCT03192176|144229986|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.46||0.5519|TWO_SIDED|95.0|-1.19|0.64||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors and baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8||0.64|-1.19|0.5519
72358739|NCT03192176|144229986|SUPERIORITY||LSMean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.46||0.1922|TWO_SIDED|95.0|-1.51|0.31||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors and baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8||0.31|-1.51|0.1922
72358740|NCT03192176|144229986|SUPERIORITY||LSMean difference|-0.9|STANDARD_ERROR_OF_MEAN|0.46||0.0463|TWO_SIDED|95.0|-1.82|-0.02||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors and baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8||-0.02|-1.82|0.0463
72358741|NCT03192176|144229986|SUPERIORITY||LSMean difference|-0.7|STANDARD_ERROR_OF_MEAN|0.44||0.1288|TWO_SIDED|95.0|-1.53|0.19||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors and baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12||0.19|-1.53|0.1288
72358742|NCT03192176|144229986|SUPERIORITY||LSMean difference|-0.8|STANDARD_ERROR_OF_MEAN|0.44||0.0577|TWO_SIDED|95.0|-1.72|0.03||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors and baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12||0.03|-1.72|0.0577
72358743|NCT03192176|144229986|SUPERIORITY||LSMean difference|-1.4|STANDARD_ERROR_OF_MEAN|0.45||0.0027|TWO_SIDED|95.0|-2.26|-0.48||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors and baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12||-0.48|-2.26|0.0027
72358744|NCT03192176|144229986|SUPERIORITY||-1.3|-1.3|STANDARD_ERROR_OF_MEAN|0.45||0.0043|TWO_SIDED|95.0|-2.2|-0.41||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors and baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12||-0.41|-2.20|0.0043
72358745|NCT03192176|144229986|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.45||0.4089|TWO_SIDED|95.0|-1.27|0.52||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors and baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12||0.52|-1.27|0.4089
72358746|NCT03192176|144229986|SUPERIORITY||LSMean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.44||0.205|TWO_SIDED|95.0|-1.44|0.31||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors and baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12||0.31|-1.44|0.2050
72358747|NCT03192176|144229986|SUPERIORITY||LSMean difference|-1.0|STANDARD_ERROR_OF_MEAN|0.44||0.0265|TWO_SIDED|95.0|-1.84|-0.11||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors and baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12||-0.11|-1.84|0.0265
72358748|NCT03192176|144229986|SUPERIORITY||LSMean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.53||0.7617|TWO_SIDED|95.0|-1.2|0.88||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors and baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15||0.88|-1.20|0.7617
72358749|NCT03192176|144229986|SUPERIORITY||LSMean difference|0.3|STANDARD_ERROR_OF_MEAN|0.53||0.6061|TWO_SIDED|95.0|-0.77|1.32||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors and baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15||1.32|-0.77|0.6061
72358750|NCT03192176|144229986|SUPERIORITY||LSMean difference|0.1|STANDARD_ERROR_OF_MEAN|0.54||0.7997|TWO_SIDED|95.0|-0.93|1.21||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors and baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15||1.21|-0.93|0.7997
72358751|NCT03192176|144229986|SUPERIORITY||LSMean difference|0.5|STANDARD_ERROR_OF_MEAN|0.55||0.3391|TWO_SIDED|95.0|-0.55|1.6||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors and baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15||1.60|-0.55|0.3391
72358752|NCT03192176|144229986|SUPERIORITY||LSMean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.55||0.3934|TWO_SIDED|95.0|-1.55|0.61||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors and baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15||0.61|-1.55|0.3934
72358753|NCT03192176|144229986|SUPERIORITY||LSMean difference|0.0|STANDARD_ERROR_OF_MEAN|0.54||0.975|TWO_SIDED|95.0|-1.08|1.04||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors and baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15||1.04|-1.08|0.9750
72358754|NCT03192176|144229986|SUPERIORITY||LSMean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.53||0.883|TWO_SIDED|95.0|-1.13|0.97||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors and baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15||0.97|-1.13|0.8830
72358755|NCT03192176|144229987|SUPERIORITY||LSMean difference|2.3|STANDARD_ERROR_OF_MEAN|4.27||0.5872|TWO_SIDED|95.0|-6.09|10.73||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 4: Ease of Getting to Sleep||10.73|-6.09|0.5872
72358756|NCT03192176|144229987|SUPERIORITY||LSMean difference|3.8|STANDARD_ERROR_OF_MEAN|4.33||0.3779|TWO_SIDED|95.0|-4.7|12.35||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 4: Ease of Getting to Sleep||12.35|-4.70|0.3779
72358757|NCT03192176|144229987|SUPERIORITY||LSMean difference|-4.1|STANDARD_ERROR_OF_MEAN|4.34||0.3506|TWO_SIDED|95.0|-12.61|4.49||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 4: Ease of Getting to Sleep||4.49|-12.61|0.3506
72358758|NCT03192176|144229987|SUPERIORITY||LSMean difference|1.0|STANDARD_ERROR_OF_MEAN|4.39||0.8236|TWO_SIDED|95.0|-7.66|9.62||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 4: Ease of Getting to Sleep||9.62|-7.66|0.8236
72358759|NCT03192176|144229987|SUPERIORITY||LSMean difference|2.3|STANDARD_ERROR_OF_MEAN|4.35||0.5949|TWO_SIDED|95.0|-6.24|10.87||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 4: Ease of Getting to Sleep||10.87|-6.24|0.5949
72358760|NCT03192176|144229987|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|4.19||0.9237|TWO_SIDED|95.0|-8.65|7.85||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 4: Ease of Getting to Sleep||7.85|-8.65|0.9237
72358761|NCT03192176|144229987|SUPERIORITY||LSMean difference|4.0|STANDARD_ERROR_OF_MEAN|4.32||0.3599|TWO_SIDED|95.0|-4.54|12.46||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 4: Ease of Getting to Sleep||12.46|-4.54|0.3599
72358762|NCT03192176|144229987|SUPERIORITY||LSMean difference|1.7|STANDARD_ERROR_OF_MEAN|5.08||0.7422|TWO_SIDED|95.0|-8.33|11.68||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 4: Quality of Sleep||11.68|-8.33|0.7422
72358763|NCT03192176|144229987|SUPERIORITY||LSMean difference|-2.6|STANDARD_ERROR_OF_MEAN|5.09||0.603|TWO_SIDED|95.0|-12.67|7.37||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 4: Quality of Sleep||7.37|-12.67|0.6030
72358764|NCT03192176|144229987|SUPERIORITY||LSMean difference|-6.0|STANDARD_ERROR_OF_MEAN|5.14||0.2478|TWO_SIDED|95.0|-16.07|4.17||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 4: Quality of Sleep||4.17|-16.07|0.2478
72358765|NCT03192176|144229987|SUPERIORITY||LSMean difference|3.3|STANDARD_ERROR_OF_MEAN|5.18||0.5295|TWO_SIDED|95.0|-6.94|13.47||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 4: Quality of Sleep||13.47|-6.94|0.5295
72358766|NCT03192176|144229987|SUPERIORITY||LSMean difference|-2.0|STANDARD_ERROR_OF_MEAN|5.16||0.6938|TWO_SIDED|95.0|-12.2|8.13||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 4: Quality of Sleep||8.13|-12.20|0.6938
72358767|NCT03192176|144229987|SUPERIORITY||LSMean difference|-0.1|STANDARD_ERROR_OF_MEAN|4.97||0.9765|TWO_SIDED|95.0|-9.93|9.63||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 4: Quality of Sleep||9.63|-9.93|0.9765
72358768|NCT03192176|144229987|SUPERIORITY||LSMean difference|3.7|STANDARD_ERROR_OF_MEAN|5.13||0.4771|TWO_SIDED|95.0|-6.45|13.76||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 4: Quality of Sleep||13.76|-6.45|0.4771
72358769|NCT03192176|144229987|SUPERIORITY||LSMean difference|3.5|STANDARD_ERROR_OF_MEAN|4.44||0.4256|TWO_SIDED|95.0|-5.19|12.27||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 4: Ease of Awaking From Sleep||12.27|-5.19|0.4256
72358770|NCT03192176|144229987|SUPERIORITY||LSMean difference|0.2|STANDARD_ERROR_OF_MEAN|4.45||0.9559|TWO_SIDED|95.0|-8.52|9.01||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 4: Ease of Awaking From Sleep||9.01|-8.52|0.9559
72358771|NCT03192176|144229987|SUPERIORITY||LSMean difference|-5.8|STANDARD_ERROR_OF_MEAN|4.49||0.2003|TWO_SIDED|95.0|-14.6|3.07||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 4: Ease of Awaking From Sleep||3.07|-14.60|0.2003
72358772|NCT03192176|144229987|SUPERIORITY||LSMean difference|-1.9|STANDARD_ERROR_OF_MEAN|4.53||0.6692|TWO_SIDED|95.0|-10.86|6.98||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 4: Ease of Awaking From Sleep||6.98|-10.86|0.6692
72358773|NCT03192176|144229987|SUPERIORITY||LSMean difference|-1.8|STANDARD_ERROR_OF_MEAN|4.51||0.6894|TWO_SIDED|95.0|-10.68|7.08||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 4: Ease of Awaking From Sleep||7.08|-10.68|0.6894
72358774|NCT03192176|144229987|SUPERIORITY||LSMean difference|-6.1|STANDARD_ERROR_OF_MEAN|4.35||0.1627|TWO_SIDED|95.0|-14.66|2.48||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 4: Ease of Awaking From Sleep||2.48|-14.66|0.1627
72358775|NCT03192176|144229987|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|4.48||0.9371|TWO_SIDED|95.0|-9.18|8.47||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 4: Ease of Awaking From Sleep||8.47|-9.18|0.9371
72358776|NCT03192176|144229987|SUPERIORITY||LSMean difference|0.8|STANDARD_ERROR_OF_MEAN|4.53||0.8521|TWO_SIDED|95.0|-8.07|9.77||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 4: Integrity of Behavior following Awaking||9.77|-8.07|0.8521
72358777|NCT03192176|144229987|SUPERIORITY||LSMean difference|0.4|STANDARD_ERROR_OF_MEAN|4.56||0.9367|TWO_SIDED|95.0|-8.62|9.35||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 4: Integrity of Behavior following Awaking||9.35|-8.62|0.9367
72358778|NCT03192176|144229987|SUPERIORITY||LSMean difference|-8.8|STANDARD_ERROR_OF_MEAN|4.57||0.0551|TWO_SIDED|95.0|-17.82|0.19||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 4: Integrity of Behavior following Awaking||0.19|-17.82|0.0551
72358779|NCT03192176|144229987|SUPERIORITY||LSMean differencce|-3.2|STANDARD_ERROR_OF_MEAN|4.64||0.4936|TWO_SIDED|95.0|-12.32|5.96||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 4: Integrity of Behavior following Awaking||5.96|-12.32|0.4936
72358780|NCT03192176|144229987|SUPERIORITY||LSMean difference|2.1|STANDARD_ERROR_OF_MEAN|4.59||0.6404|TWO_SIDED|95.0|-6.89|11.17||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 4: Integrity of Behavior following Awaking||11.17|-6.89|0.6404
72358781|NCT03192176|144229987|SUPERIORITY||LSMean difference|0.6|STANDARD_ERROR_OF_MEAN|4.45||0.8955|TWO_SIDED|95.0|-8.17|9.34||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 4: Integrity of Behavior following Awaking||9.34|-8.17|0.8955
72358782|NCT03192176|144229987|SUPERIORITY||LSMean difference|0.1|STANDARD_ERROR_OF_MEAN|4.59||0.9776|TWO_SIDED|95.0|-8.91|9.17||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 4: Integrity of Behavior following Awaking||9.17|-8.91|0.9776
72358783|NCT03192176|144229987|SUPERIORITY||LSMean difference|-1.1|STANDARD_ERROR_OF_MEAN|4.14||0.7852|TWO_SIDED|95.0|-9.27|7.01||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 8: Ease of Getting to Sleep||7.01|-9.27|0.7852
72358784|NCT03192176|144229987|SUPERIORITY||LSMean difference|1.2|STANDARD_ERROR_OF_MEAN|4.15||0.7812|TWO_SIDED|95.0|-7.02|9.33||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 8: Ease of Getting to Sleep||9.33|-7.02|0.7812
72358785|NCT03192176|144229987|SUPERIORITY||LSMean difference|-4.7|STANDARD_ERROR_OF_MEAN|4.23||0.2648|TWO_SIDED|95.0|-13.07|3.61||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 8: Ease of Getting to Sleep||3.61|-13.07|0.2648
72358786|NCT03192176|144229987|SUPERIORITY||LSMean difference|-2.0|STANDARD_ERROR_OF_MEAN|4.25||0.6312|TWO_SIDED|95.0|-10.41|6.32||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 8: Ease of Getting to Sleep||6.32|-10.41|0.6312
72358787|NCT03192176|144229987|SUPERIORITY||LSMean difference|1.4|STANDARD_ERROR_OF_MEAN|4.2||0.7416|TWO_SIDED|95.0|-6.89|9.67||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 8: Ease of Getting to Sleep||9.67|-6.89|0.7416
72358788|NCT03192176|144229987|SUPERIORITY||LSMean difference|3.3|STANDARD_ERROR_OF_MEAN|4.12||0.4254|TWO_SIDED|95.0|-4.83|11.41||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 8: Ease of Getting to Sleep||11.41|-4.83|0.4254
72358789|NCT03192176|144229987|SUPERIORITY||LSMean difference|3.4|STANDARD_ERROR_OF_MEAN|4.11||0.4038|TWO_SIDED|95.0|-4.66|11.54||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 8: Ease of Getting to Sleep||11.54|-4.66|0.4038
72358790|NCT03192176|144229987|SUPERIORITY||LSMean difference|-4.8|STANDARD_ERROR_OF_MEAN|4.91||0.327|TWO_SIDED|95.0|-14.49|4.85||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 8: Quality of Sleep||4.85|-14.49|0.3270
72358791|NCT03192176|144229987|SUPERIORITY||LSMean difference|-1.7|STANDARD_ERROR_OF_MEAN|4.85||0.7333|TWO_SIDED|95.0|-11.21|7.9||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 8: Quality of Sleep||7.90|-11.21|0.7333
72358792|NCT03192176|144229987|SUPERIORITY||LSMean difference|-7.5|STANDARD_ERROR_OF_MEAN|4.99||0.1319|TWO_SIDED|95.0|-17.36|2.28||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 8: Quality of Sleep||2.28|-17.36|0.1319
72358793|NCT03192176|144229987|SUPERIORITY||LSMean difference|-2.5|STANDARD_ERROR_OF_MEAN|5.0||0.6132|TWO_SIDED|95.0|-12.38|7.32||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 8: Quality of Sleep||7.32|-12.38|0.6132
72358794|NCT03192176|144229987|SUPERIORITY||LSMean difference|-4.2|STANDARD_ERROR_OF_MEAN|4.98||0.4024|TWO_SIDED|95.0|-13.98|5.63||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 8: Quality of Sleep||5.63|-13.98|0.4024
72358795|NCT03192176|144229987|SUPERIORITY||LSMean difference|-3.4|STANDARD_ERROR_OF_MEAN|4.88||0.4904|TWO_SIDED|95.0|-12.97|6.23||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 8: Quality of Sleep||6.23|-12.97|0.4904
72358796|NCT03192176|144229987|SUPERIORITY||LSMean difference|-2.9|STANDARD_ERROR_OF_MEAN|4.87||0.5521|TWO_SIDED|95.0|-12.48|6.69||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 8: Quality of Sleep||6.69|-12.48|0.5521
72358797|NCT03192176|144229987|SUPERIORITY||LSMean difference|-1.5|STANDARD_ERROR_OF_MEAN|4.5||0.737|TWO_SIDED|95.0|-10.38|7.35||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 8: Ease of Awaking From Sleep||7.35|-10.38|0.7370
72358798|NCT03192176|144229987|SUPERIORITY||LSMean difference|-2.8|STANDARD_ERROR_OF_MEAN|4.46||0.5269|TWO_SIDED|95.0|-11.62|5.96||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 8: Ease of Awaking From Sleep||5.96|-11.62|0.5269
72358799|NCT03192176|144229987|SUPERIORITY||LSMean difference|-3.9|STANDARD_ERROR_OF_MEAN|4.58||0.3937|TWO_SIDED|95.0|-12.93|5.11||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 8: Ease of Awaking From Sleep||5.11|-12.93|0.3937
72358800|NCT03192176|144229987|SUPERIORITY||LSMean difference|0.9|STANDARD_ERROR_OF_MEAN|4.59||0.846|TWO_SIDED|95.0|-8.15|9.94||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 8: Ease of Awaking From Sleep||9.94|-8.15|0.8460
72358801|NCT03192176|144229987|SUPERIORITY||LSMean difference|-2.6|STANDARD_ERROR_OF_MEAN|4.57||0.5673|TWO_SIDED|95.0|-11.62|6.38||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 8: Ease of Awaking From Sleep||6.38|-11.62|0.5673
72358802|NCT03192176|144229987|SUPERIORITY||LSMean difference|4.0|STANDARD_ERROR_OF_MEAN|4.49||0.3791|TWO_SIDED|95.0|-4.88|12.79||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 8: Ease of Awaking From Sleep||12.79|-4.88|0.3791
72358803|NCT03192176|144229987|SUPERIORITY||LSMean difference|0.9|STANDARD_ERROR_OF_MEAN|4.47||0.834|TWO_SIDED|95.0|-7.86|9.73||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 8: Ease of Awaking From Sleep||9.73|-7.86|0.8340
72429360|NCT01154036|144369678|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least-squares Means|-1.5||||0.831|TWO_SIDED|95.0|-15.7|12.6|||Constrained Longitudinal Data Analysis|Geometric mean percent changes from baseline were calculated based on back-transformation via exponentiation of the model-based least square means||||12.6|-15.7|0.831
72358804|NCT03192176|144229987|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|4.67||0.9457|TWO_SIDED|95.0|-9.51|8.88||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 8: Integrity of Behavior Following Awaking||8.88|-9.51|0.9457
72358805|NCT03192176|144229987|SUPERIORITY||LSMean difference|-2.1|STANDARD_ERROR_OF_MEAN|4.65||0.657|TWO_SIDED|95.0|-11.22|7.09||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 8: Integrity of Behavior Following Awaking||7.09|-11.22|0.6570
72358806|NCT03192176|144229987|SUPERIORITY||LSMean difference|-5.7|STANDARD_ERROR_OF_MEAN|4.73||0.231|TWO_SIDED|95.0|-15.0|3.64||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 8: Integrity of Behavior Following Awaking||3.64|-15.00|0.2310
72358807|NCT03192176|144229987|SUPERIORITY||LSMean difference|0.6|STANDARD_ERROR_OF_MEAN|4.77||0.9066|TWO_SIDED|95.0|-8.84|9.96||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 8: Integrity of Behavior Following Awaking||9.96|-8.84|0.9066
72358808|NCT03192176|144229987|SUPERIORITY||LSMean differnce|-5.0|STANDARD_ERROR_OF_MEAN|4.71||0.2914|TWO_SIDED|95.0|-14.26|4.3||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 8: Integrity of Behavior Following Awaking||4.30|-14.26|0.2914
72358809|NCT03192176|144229987|SUPERIORITY||LSMean difference|0.4|STANDARD_ERROR_OF_MEAN|4.64||0.9277|TWO_SIDED|95.0|-8.73|9.57||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 8: Integrity of Behavior Following Awaking||9.57|-8.73|0.9277
72358810|NCT03192176|144229987|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|4.64||0.9367|TWO_SIDED|95.0|-9.51|8.77||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 8: Integrity of Behavior Following Awaking||8.77|-9.51|0.9367
72358811|NCT03192176|144229987|SUPERIORITY||LSMean difference|5.1|STANDARD_ERROR_OF_MEAN|4.35||0.2407|TWO_SIDED|95.0|-3.46|13.69||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 12: Ease of Getting to Sleep||13.69|-3.46|0.2407
72358812|NCT03192176|144229987|SUPERIORITY||LSMean difference|6.9|STANDARD_ERROR_OF_MEAN|4.55||0.1305|TWO_SIDED|95.0|-2.06|15.89||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 12: Ease of Getting to Sleep||15.89|-2.06|0.1305
72358813|NCT03192176|144229987|SUPERIORITY||LSMean difference|5.7|STANDARD_ERROR_OF_MEAN|4.59||0.2152|TWO_SIDED|95.0|-3.34|14.75||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 12: Ease of Getting to Sleep||14.75|-3.34|0.2152
72358814|NCT03192176|144229987|SUPERIORITY||LSMean difference|7.6|STANDARD_ERROR_OF_MEAN|4.72||0.1099|TWO_SIDED|95.0|-1.73|16.89||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 12: Ease of Getting to Sleep||16.89|-1.73|0.1099
72358815|NCT03192176|144229987|SUPERIORITY||LSMean difference|7.4|STANDARD_ERROR_OF_MEAN|4.75||0.1219|TWO_SIDED|95.0|-1.99|16.75||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 12: Ease of Getting to Sleep||16.75|-1.99|0.1219
72358816|NCT03192176|144229987|SUPERIORITY||LSMean difference|9.6|STANDARD_ERROR_OF_MEAN|4.44||0.0316|TWO_SIDED|95.0|0.85|18.36||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 12: Ease of Getting to Sleep||18.36|0.85|0.0316
72358817|NCT03192176|144229987|SUPERIORITY||LSMean difference|6.4|STANDARD_ERROR_OF_MEAN|4.47||0.1557|TWO_SIDED|95.0|-2.44|15.16||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 12: Ease of Getting to Sleep||15.16|-2.44|0.1557
72358818|NCT03192176|144229987|SUPERIORITY||LSMean difference|0.9|STANDARD_ERROR_OF_MEAN|4.97||0.8592|TWO_SIDED|95.0|-8.91|10.67||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 12: Quality of Sleep||10.67|-8.91|0.8592
72358819|NCT03192176|144229987|SUPERIORITY||LSMean difference|2.1|STANDARD_ERROR_OF_MEAN|5.15||0.6891|TWO_SIDED|95.0|-8.08|12.2||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 12: Quality of Sleep||12.20|-8.08|0.6891
72429361|NCT01154036|144369679|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least-squares Means|-13.1||||0.187|TWO_SIDED|95.0|-32.6|6.4|||Constrained Longitudinal Data Analysis|Geometric mean percent changes from baseline were calculated based on back-transformation via exponentiation of the model-based least square means||||6.4|-32.6|0.187
72358820|NCT03192176|144229987|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|5.2||0.9481|TWO_SIDED|95.0|-10.59|9.92||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 12: Quality of Sleep||9.92|-10.59|0.9481
72358821|NCT03192176|144229987|SUPERIORITY||LSMean difference|-1.9|STANDARD_ERROR_OF_MEAN|5.36||0.7246|TWO_SIDED|95.0|-12.46|8.68||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 12: Quality of Sleep||8.68|-12.46|0.7246
72358822|NCT03192176|144229987|SUPERIORITY||LSMean difference|0.8|STANDARD_ERROR_OF_MEAN|5.45||0.8842|TWO_SIDED|95.0|-9.94|11.53||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 12: Quality of Sleep||11.53|-9.94|0.8842
72358823|NCT03192176|144229987|SUPERIORITY||LSMean difference|1.2|STANDARD_ERROR_OF_MEAN|5.05||0.8103|TWO_SIDED|95.0|-8.74|11.17||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 12: Quality of Sleep||11.17|-8.74|0.8103
72358824|NCT03192176|144229987|SUPERIORITY||LSMean difference|0.2|STANDARD_ERROR_OF_MEAN|5.1||0.9631|TWO_SIDED|95.0|-9.81|10.28||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 12: Quality of Sleep||10.28|-9.81|0.9631
72358825|NCT03192176|144229987|SUPERIORITY||LSMean difference|-0.1|STANDARD_ERROR_OF_MEAN|4.87||0.9788|TWO_SIDED|95.0|-9.73|9.47||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 12: Ease of Awaking From Sleep||9.47|-9.73|0.9788
72358826|NCT03192176|144229987|SUPERIORITY||LSMean difference|-1.4|STANDARD_ERROR_OF_MEAN|5.02||0.7875|TWO_SIDED|95.0|-11.26|8.54||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 12: Ease of Awaking From Sleep||8.54|-11.26|0.7875
72358827|NCT03192176|144229987|SUPERIORITY||LSMean difference|0.2|STANDARD_ERROR_OF_MEAN|5.08||0.9746|TWO_SIDED|95.0|-9.85|10.17||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 12: Ease of Awaking From Sleep||10.17|-9.85|0.9746
72358828|NCT03192176|144229987|SUPERIORITY||LSMean difference|0.6|STANDARD_ERROR_OF_MEAN|5.21||0.9092|TWO_SIDED|95.0|-9.67|10.86||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 12: Ease of Awaking From Sleep||10.86|-9.67|0.9092
72358829|NCT03192176|144229987|SUPERIORITY||LSMean difference|-0.2|STANDARD_ERROR_OF_MEAN|5.27||0.9745|TWO_SIDED|95.0|-10.55|10.21||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 12: Ease of Awaking From Sleep||10.21|-10.55|0.9745
72358830|NCT03192176|144229987|SUPERIORITY||LSMean difference|4.7|STANDARD_ERROR_OF_MEAN|4.95||0.3458|TWO_SIDED|95.0|-5.08|14.44||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 12: Ease of Awaking From Sleep||14.44|-5.08|0.3458
72358831|NCT03192176|144229987|SUPERIORITY||LSMean differnce|3.6|STANDARD_ERROR_OF_MEAN|4.98||0.4657|TWO_SIDED|95.0|-6.17|13.45||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 12: Ease of Awaking From Sleep||13.45|-6.17|0.4657
72358832|NCT03192176|144229987|SUPERIORITY||LSMean difference|2.8|STANDARD_ERROR_OF_MEAN|5.07||0.5838|TWO_SIDED|95.0|-7.2|12.76||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 12: Integrity of Behavior Following Awaking||12.76|-7.20|0.5838
72358833|NCT03192176|144229987|SUPERIORITY||LSMean difference|1.1|STANDARD_ERROR_OF_MEAN|5.22||0.8322|TWO_SIDED|95.0|-9.18|11.39||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 12: Integrity of Behavior Following Awaking||11.39|-9.18|0.8322
72358834|NCT03192176|144229987|SUPERIORITY||LSMean difference|1.8|STANDARD_ERROR_OF_MEAN|5.26||0.7366|TWO_SIDED|95.0|-8.59|12.13||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 12: Integrity of Behavior Following Awaking||12.13|-8.59|0.7366
72358835|NCT03192176|144229987|SUPERIORITY||LSMean difference|5.6|STANDARD_ERROR_OF_MEAN|5.4||0.2971|TWO_SIDED|95.0|-4.99|16.28||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 12: Integrity of Behavior Following Awaking||16.28|-4.99|0.2971
72429362|NCT01154036|144369679|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least-squares Means|-11.6||||0.153|TWO_SIDED|95.0|-27.7|4.4|||Constrained Longitudinal Data Analysis|Geometric mean percent changes from baseline were calculated based on back-transformation via exponentiation of the model-based least square means||||4.4|-27.7|0.153
72358836|NCT03192176|144229987|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|5.41||0.9562|TWO_SIDED|95.0|-10.96|10.37||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 12: Integrity of Behavior Following Awaking||10.37|-10.96|0.9562
72358837|NCT03192176|144229987|SUPERIORITY||0.28|8.7|STANDARD_ERROR_OF_MEAN|5.13||0.0926|TWO_SIDED|95.0|-1.44|18.76||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 12: Integrity of Behavior Following Awaking||18.76|-1.44|0.0926
72358838|NCT03192176|144229987|SUPERIORITY||LSMean difference|3.5|STANDARD_ERROR_OF_MEAN|5.18||0.4996|TWO_SIDED|95.0|-6.7|13.7||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 12: Integrity of Behavior Following Awaking||13.70|-6.70|0.4996
72358839|NCT03192176|144229987|SUPERIORITY||LSMean difference|-0.6|STANDARD_ERROR_OF_MEAN|4.76||0.896|TWO_SIDED|95.0|-9.99|8.75||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 15: Ease of Getting to Sleep||8.75|-9.99|0.8960
72358840|NCT03192176|144229987|SUPERIORITY||LSMean difference|2.9|STANDARD_ERROR_OF_MEAN|4.89||0.5471|TWO_SIDED|95.0|-6.68|12.58||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 15: Ease of Getting to Sleep||12.58|-6.68|0.5471
72358841|NCT03192176|144229987|SUPERIORITY||LSMean difference|1.7|STANDARD_ERROR_OF_MEAN|4.93||0.738|TWO_SIDED|95.0|-8.06|11.36||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 15: Ease of Getting to Sleep||11.36|-8.06|0.7380
72358842|NCT03192176|144229987|SUPERIORITY||LSMean difference|9.6|STANDARD_ERROR_OF_MEAN|5.14||0.0644|TWO_SIDED|95.0|-0.58|19.69||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 15: Ease of Getting to Sleep||19.69|-0.58|0.0644
72358843|NCT03192176|144229987|SUPERIORITY||LSMean difference|-1.0|STANDARD_ERROR_OF_MEAN|5.04||0.8475|TWO_SIDED|95.0|-10.9|8.96||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 15: Ease of Getting to Sleep||8.96|-10.90|0.8475
72358844|NCT03192176|144229987|SUPERIORITY||LSMean difference|5.0|STANDARD_ERROR_OF_MEAN|4.86||0.3044|TWO_SIDED|95.0|-4.57|14.59||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 15: Ease of Getting to Sleep||14.59|-4.57|0.3044
72358845|NCT03192176|144229987|SUPERIORITY||LSMean difference|4.2|STANDARD_ERROR_OF_MEAN|4.89||0.3895|TWO_SIDED|95.0|-5.42|13.86||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 15: Ease of Getting to Sleep||13.86|-5.42|0.3895
72358846|NCT03192176|144229987|SUPERIORITY||LSMean difference|-4.5|STANDARD_ERROR_OF_MEAN|6.07||0.4551|TWO_SIDED|95.0|-16.5|7.42||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 15: Quality of Sleep||7.42|-16.50|0.4551
72358847|NCT03192176|144229987|SUPERIORITY||LSMean differencce|-2.2|STANDARD_ERROR_OF_MEAN|6.1||0.7182|TWO_SIDED|95.0|-14.21|9.81||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 15: Quality of Sleep||9.81|-14.21|0.7182
72358848|NCT03192176|144229987|SUPERIORITY||LSMean difference|-3.0|STANDARD_ERROR_OF_MEAN|6.21||0.6259|TWO_SIDED|95.0|-15.26|9.2||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 15: Quality of Sleep||9.20|-15.26|0.6259
72358849|NCT03192176|144229987|SUPERIORITY||LSMean difference|6.6|STANDARD_ERROR_OF_MEAN|6.5||0.312|TWO_SIDED|95.0|-6.22|19.4||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 15: Quality of Sleep||19.40|-6.22|0.3120
72358850|NCT03192176|144229987|SUPERIORITY||LSMean difference|-6.3|STANDARD_ERROR_OF_MEAN|6.41||0.3297|TWO_SIDED|95.0|-18.89|6.37||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 15: Quality of Sleep||6.37|-18.89|0.3297
72358851|NCT03192176|144229987|SUPERIORITY||LSMean difference|3.1|STANDARD_ERROR_OF_MEAN|6.16||0.613|TWO_SIDED|95.0|-9.02|15.26||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 15: Quality of Sleep||15.26|-9.02|0.6130
72358852|NCT03192176|144229987|SUPERIORITY||LSMean difference|2.2|STANDARD_ERROR_OF_MEAN|6.22||0.7292|TWO_SIDED|95.0|-10.09|14.4||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 15: Quality of Sleep||14.40|-10.09|0.7292
72358853|NCT03192176|144229987|SUPERIORITY||LSMean difference|0.9|STANDARD_ERROR_OF_MEAN|5.6||0.8695|TWO_SIDED|95.0|-1.11|11.96||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 15: Ease of Awaking From Sleep||11.96|-1.11|0.8695
72358854|NCT03192176|144229987|SUPERIORITY||LSMean difference|3.1|STANDARD_ERROR_OF_MEAN|5.64||0.58|TWO_SIDED|95.0|-7.99|14.25||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 15: Ease of Awaking From Sleep||14.25|-7.99|0.5800
72358855|NCT03192176|144229987|SUPERIORITY||LSMean difference|2.2|STANDARD_ERROR_OF_MEAN|5.74||0.7024|TWO_SIDED|95.0|-9.11|13.5||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 15: Ease of Awaking From Sleep||13.50|-9.11|0.7024
72358856|NCT03192176|144229987|SUPERIORITY||LSMean difference|11.4|STANDARD_ERROR_OF_MEAN|5.99||0.0572|TWO_SIDED|95.0|-0.35|23.23||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 15: Ease of Awaking From Sleep||23.23|-0.35|0.0572
72358857|NCT03192176|144229987|SUPERIORITY||LSMean difference|1.6|STANDARD_ERROR_OF_MEAN|5.93||0.783|TWO_SIDED|95.0|-10.04|13.31||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 15: Ease of Awaking From Sleep||13.31|-10.04|0.7830
72358858|NCT03192176|144229987|SUPERIORITY||0.1|15.4|STANDARD_ERROR_OF_MEAN|5.71||0.0074|TWO_SIDED|95.0|4.19|26.67||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 15: Ease of Awaking From Sleep||26.67|4.19|0.0074
72358859|NCT03192176|144229987|SUPERIORITY||LSMean difference|11.0|STANDARD_ERROR_OF_MEAN|5.73||0.0551|TWO_SIDED|95.0|-0.24|22.32||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 15: Ease of Awaking From Sleep||22.32|-0.24|0.0551
72358860|NCT03192176|144229987|SUPERIORITY||LSMean difference|-5.8|STANDARD_ERROR_OF_MEAN|5.51||0.2959|TWO_SIDED|95.0|-16.63|5.08||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 15: Integrity of Behavior Following Awaking||5.08|-16.63|0.2959
72358861|NCT03192176|144229987|SUPERIORITY||LSMean difference|5.8|STANDARD_ERROR_OF_MEAN|5.55||0.2976|TWO_SIDED|95.0|-5.14|16.74||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 15: Integrity of Behavior Following Awaking||16.74|-5.14|0.2976
72358862|NCT03192176|144229987|SUPERIORITY||LSMean difference|2.0|STANDARD_ERROR_OF_MEAN|5.62||0.7236|TWO_SIDED|95.0|-9.07|13.05||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 15: Integrity of Behavior Following Awaking||13.05|-9.07|0.7236
72358863|NCT03192176|144229987|SUPERIORITY||LSMean difference|10.1|STANDARD_ERROR_OF_MEAN|5.88||0.0884|TWO_SIDED|95.0|-1.52|21.63||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 15: Integrity of Behavior Following Awaking||21.63|-1.52|0.0884
72358864|NCT03192176|144229987|SUPERIORITY||LSMean difference|-5.0|STANDARD_ERROR_OF_MEAN|5.77||0.3887|TWO_SIDED|95.0|-16.35|6.38||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 15: Integrity of Behavior Following Awaking||6.38|-16.35|0.3887
72358865|NCT03192176|144229987|SUPERIORITY||LSMean difference|6.2|STANDARD_ERROR_OF_MEAN|5.59||0.2671|TWO_SIDED|95.0|-4.8|17.24||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 15: Integrity of Behavior Following Awaking||17.24|-4.80|0.2671
72358866|NCT03192176|144229987|SUPERIORITY||LSMean difference|2.9|STANDARD_ERROR_OF_MEAN|5.63||0.6076|TWO_SIDED|95.0|-8.2|13.99||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 15: Integrity of Behavior Following Awaking||13.99|-8.20|0.6076
72358867|NCT03192176|144229988|SUPERIORITY||LSMean difference|-1.1|STANDARD_ERROR_OF_MEAN|0.91||0.2159|TWO_SIDED|95.0|-2.93|0.67||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 4: Psychological Symptoms Score||0.67|-2.93|0.2159
72358868|NCT03192176|144229988|SUPERIORITY||LSMean difference|-1.9|STANDARD_ERROR_OF_MEAN|0.92||0.0405|TWO_SIDED|95.0|-3.7|-0.08||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 4: Psychological Symptoms Score||-0.08|-3.70|0.0405
72358869|NCT03192176|144229988|SUPERIORITY||LSMean difference|-2.4|STANDARD_ERROR_OF_MEAN|0.93||0.0115|TWO_SIDED|95.0|-4.18|-0.53||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 4: Psychological Symptoms Score||-0.53|-4.18|0.0115
72358870|NCT03192176|144229988|SUPERIORITY||LSMean difference|-1.8|STANDARD_ERROR_OF_MEAN|0.93||0.0553|TWO_SIDED|95.0|-3.62|0.04||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 4: Psychological Symptoms Score||0.04|-3.62|0.0553
72358871|NCT03192176|144229988|SUPERIORITY||LSMean difference|-1.0|STANDARD_ERROR_OF_MEAN|0.92||0.2753|TWO_SIDED|95.0|-2.82|0.8||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 4: Psychological Symptoms Score||0.80|-2.82|0.2753
72358872|NCT03192176|144229988|SUPERIORITY||LSMean difference|0.6|STANDARD_ERROR_OF_MEAN|0.91||0.514|TWO_SIDED|95.0|-1.2|2.4||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 4: Psychological Symptoms Score||2.40|-1.20|0.5140
72358873|NCT03192176|144229988|SUPERIORITY||LSMean difference|-2.2|STANDARD_ERROR_OF_MEAN|0.93||0.0178|TWO_SIDED|95.0|-4.03|-0.38||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 4: Psychological Symptoms Score||-0.38|-4.03|0.0178
72358874|NCT03192176|144229988|SUPERIORITY||LSMean difference|0.0|STANDARD_ERROR_OF_MEAN|0.51||0.9675|TWO_SIDED|95.0|-1.02|0.98||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 4: Physical Symptoms Score||0.98|-1.02|0.9675
72358875|NCT03192176|144229988|SUPERIORITY||LSMean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.51||0.3122|TWO_SIDED|95.0|-1.52|0.49||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 4: Physical Symptoms Score||0.49|-1.52|0.3122
72358876|NCT03192176|144229988|SUPERIORITY||LSMean difference|0.0|STANDARD_ERROR_OF_MEAN|0.51||0.9977|TWO_SIDED|95.0|-1.0|1.0||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 4: Physical Symptoms Score||1.00|-1.00|0.9977
72358877|NCT03192176|144229988|SUPERIORITY||LSMean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.51||0.9312|TWO_SIDED|95.0|-1.05|0.97||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 4: Physical Symptoms Score||0.97|-1.05|0.9312
72358878|NCT03192176|144229988|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.51||0.6005|TWO_SIDED|95.0|-1.27|0.74||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 4: Physical Symptoms Score||0.74|-1.27|0.6005
72358879|NCT03192176|144229988|SUPERIORITY||LSMean difference|0.3|STANDARD_ERROR_OF_MEAN|0.51||0.5284|TWO_SIDED|95.0|-0.68|1.32||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 4: Physical Symptoms Score||1.32|-0.68|0.5284
72358880|NCT03192176|144229988|SUPERIORITY||LSMean difference|-0.8|STANDARD_ERROR_OF_MEAN|0.51||0.1111|TWO_SIDED|95.0|-1.82|0.19||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 4: Physical Symptoms Score||0.19|-1.82|0.1111
72358881|NCT03192176|144229988|SUPERIORITY||LSMean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.35||0.1764|TWO_SIDED|95.0|-1.16|0.21||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 4: Vasomotor Symptoms Score||0.21|-1.16|0.1764
72358882|NCT03192176|144229988|SUPERIORITY||LSMean difference|-1.0|STANDARD_ERROR_OF_MEAN|0.35||0.0037|TWO_SIDED|95.0|-1.73|-0.34||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 4: Vasomotor Symptoms||-0.34|-1.73|0.0037
72358883|NCT03192176|144229988|SUPERIORITY||LSMean difference|-1.6|STANDARD_ERROR_OF_MEAN|0.35|<|0.0001|TWO_SIDED|95.0|-2.3|-0.92||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 4: Vasomotor Symptoms Score||-0.92|-2.30|<0.0001
72358884|NCT03192176|144229988|SUPERIORITY||LSMean difference|-1.5|STANDARD_ERROR_OF_MEAN|0.36|<|0.0001|TWO_SIDED|95.0|-2.21|-0.81||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 4: Vasomotor Symptoms Score||-0.81|-2.21|<0.0001
72358885|NCT03192176|144229988|SUPERIORITY||LSMean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.35||0.1444|TWO_SIDED|95.0|-1.21|0.18||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 4: Vasomotor Symptoms Score||0.18|-1.21|0.1444
72358886|NCT03192176|144229988|SUPERIORITY||LSMean difference|-0.9|STANDARD_ERROR_OF_MEAN|0.35||0.0088|TWO_SIDED|95.0|-1.6|-0.23||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 4: Vasomotor Symptoms Score||-0.23|-1.60|0.0088
72358887|NCT03192176|144229988|SUPERIORITY||LSMean difference|-1.2|STANDARD_ERROR_OF_MEAN|0.35||0.0005|TWO_SIDED|95.0|-1.93|-0.54||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 4: Vasomotor Symptoms Score||-0.54|-1.93|0.0005
72358888|NCT03192176|144229988|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.17||0.0416|TWO_SIDED|95.0|-0.69|-0.01||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 4: Sexual Dysfunction Score||-0.01|-0.69|0.0416
72358889|NCT03192176|144229988|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.17||0.0353|TWO_SIDED|95.0|-0.71|-0.03||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 4: Sexual Dysfunction Score||-0.03|-0.71|0.0353
72358890|NCT03192176|144229988|SUPERIORITY||LSMean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.17||0.004|TWO_SIDED|95.0|-0.84|-0.16||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 4: Sexual Dysfunction Score||-0.16|-0.84|0.0040
72358891|NCT03192176|144229988|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.17||0.0495|TWO_SIDED|95.0|-0.69|0.0||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 4: Sexual Dysfunction Score||-0.00|-0.69|0.0495
72358892|NCT03192176|144229988|SUPERIORITY||LSMean difference|0.0|STANDARD_ERROR_OF_MEAN|0.17||0.8665|TWO_SIDED|95.0|-0.31|0.37||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 4: Sexual Dysfunction Score||0.37|-0.31|0.8665
72358893|NCT03192176|144229988|SUPERIORITY||LSMean difference|0.0|STANDARD_ERROR_OF_MEAN|0.17||0.9303|TWO_SIDED|95.0|-0.35|0.32||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 4: Sexual Dysfunction Score||0.32|-0.35|0.9303
72358894|NCT03192176|144229988|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.17||0.1039|TWO_SIDED|95.0|-0.62|0.06||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 4: Sexual Dysfunction Score||0.06|-0.62|0.1039
72358895|NCT03192176|144229988|SUPERIORITY||LSMean difference|-1.8|STANDARD_ERROR_OF_MEAN|1.54||0.2547|TWO_SIDED|95.0|-4.78|1.27||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 4: Total Score||1.27|-4.78|0.2547
72358896|NCT03192176|144229988|SUPERIORITY||LSMean difference|-3.6|STANDARD_ERROR_OF_MEAN|1.55||0.0225|TWO_SIDED|95.0|-6.6|-0.5||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 4: Total Score||-0.50|-6.60|0.0225
72358897|NCT03192176|144229988|SUPERIORITY||LSMean differencce|-4.3|STANDARD_ERROR_OF_MEAN|1.55||0.0058|TWO_SIDED|95.0|-7.38|-1.26||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 4: Total Score||-1.26|-7.38|0.0058
72358898|NCT03192176|144229988|SUPERIORITY||LSMean difference|-3.4|STANDARD_ERROR_OF_MEAN|1.56||0.0301|TWO_SIDED|95.0|-6.48|-0.33||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 4: Total Score||-0.33|-6.48|0.0301
72358899|NCT03192176|144229988|SUPERIORITY||LSMean difference|-1.5|STANDARD_ERROR_OF_MEAN|1.55||0.322|TWO_SIDED|95.0|-4.59|1.51||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 4: Total Score||1.51|-4.59|0.3220
72358900|NCT03192176|144229988|SUPERIORITY||LSMean difference|0.2|STANDARD_ERROR_OF_MEAN|1.54||0.8782|TWO_SIDED|95.0|-2.8|3.27||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 4: Total Score||3.27|-2.80|0.8782
72358901|NCT03192176|144229988|SUPERIORITY||LSMean difference|-4.2|STANDARD_ERROR_OF_MEAN|1.55||0.0069|TWO_SIDED|95.0|-7.27|-1.17||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 4: Total Score||-1.17|-7.27|0.0069
72358902|NCT03192176|144229988|SUPERIORITY||LSMean difference|-1.6|STANDARD_ERROR_OF_MEAN|0.95||0.089|TWO_SIDED|95.0|-3.49|0.25||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 8: Psychological Symptoms Score||0.25|-3.49|0.0890
72358903|NCT03192176|144229988|SUPERIORITY||LSMean difference|-1.4|STANDARD_ERROR_OF_MEAN|0.95||0.1444|TWO_SIDED|95.0|-3.25|0.48||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 8: Psychological Symptoms Score||0.48|-3.25|0.1444
72358904|NCT03192176|144229988|SUPERIORITY||LSMean difference|-1.6|STANDARD_ERROR_OF_MEAN|0.97||0.1022|TWO_SIDED|95.0|-3.51|0.32||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 8: Psychological Symptoms Score||0.32|-3.51|0.1022
72358905|NCT03192176|144229988|SUPERIORITY||LSMean difference|-1.2|STANDARD_ERROR_OF_MEAN|0.97||0.2342|TWO_SIDED|95.0|-3.07|0.75||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 8: Psychological Symptoms Score||0.75|-3.07|0.2342
72358906|NCT03192176|144229988|SUPERIORITY||LSMean difference|0.0|STANDARD_ERROR_OF_MEAN|0.96||0.9906|TWO_SIDED|95.0|-1.89|1.87||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 8: Psychological Symptoms Score||1.87|-1.89|0.9906
72358907|NCT03192176|144229988|SUPERIORITY||LSMean difference|0.5|STANDARD_ERROR_OF_MEAN|0.95||0.577|TWO_SIDED|95.0|-1.34|2.4||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 8: Psychological Symptoms Score||2.40|-1.34|0.5770
72358908|NCT03192176|144229988|SUPERIORITY||LSMean difference|-1.3|STANDARD_ERROR_OF_MEAN|0.95||0.1865|TWO_SIDED|95.0|-3.14|0.61||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 8: Psychological Symptoms Score||0.61|-3.14|0.1865
72358909|NCT03192176|144229988|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.53||0.4575|TWO_SIDED|95.0|-1.45|0.65||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 8: Physical Symptoms Score||0.65|-1.45|0.4575
72358910|NCT03192176|144229988|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.53||0.6016|TWO_SIDED|95.0|-1.33|0.77||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 8: Physical Symptoms Score||0.77|-1.33|0.6016
72358911|NCT03192176|144229988|SUPERIORITY||LSMean difference|0.2|STANDARD_ERROR_OF_MEAN|0.54||0.7026|TWO_SIDED|95.0|-0.86|1.28||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 8: Physical Symptoms Score||1.28|-0.86|0.7026
72358912|NCT03192176|144229988|SUPERIORITY||LSMean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.54||0.2971|TWO_SIDED|95.0|-1.64|0.5||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 8: Physical Symptoms Score||0.50|-1.64|0.2971
72358913|NCT03192176|144229988|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.54||0.5491|TWO_SIDED|95.0|-1.38|0.74||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 8: Physical Symptoms Score||0.74|-1.38|0.5491
72358914|NCT03192176|144229988|SUPERIORITY||LSMean difference|0.2|STANDARD_ERROR_OF_MEAN|0.54||0.7142|TWO_SIDED|95.0|-0.86|1.25||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 8: Physical Symptoms Score||1.25|-0.86|0.7142
72358915|NCT03192176|144229988|SUPERIORITY||LSMean difference|-0.8|STANDARD_ERROR_OF_MEAN|0.53||0.1157|TWO_SIDED|95.0|-1.89|0.21||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 8: Physical Symptoms Score||0.21|-1.89|0.1157
72358916|NCT03192176|144229988|SUPERIORITY||LSMean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.36||0.1114|TWO_SIDED|95.0|-1.3|0.14||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 8: Vasomotor Symptoms Score||0.14|-1.30|0.1114
72358917|NCT03192176|144229988|SUPERIORITY||LSMean difference|-1.1|STANDARD_ERROR_OF_MEAN|0.36||0.0025|TWO_SIDED|95.0|-1.83|-0.4||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 8: Vasomotor Symptoms Score||-0.40|-1.83|0.0025
72358918|NCT03192176|144229988|SUPERIORITY||LSMean difference|-1.5|STANDARD_ERROR_OF_MEAN|0.37|<|0.0001|TWO_SIDED|95.0|-2.2|-0.74||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 8: Vasomotor Symptoms Scre||-0.74|-2.20|<0.0001
72358919|NCT03192176|144229988|SUPERIORITY||LSMean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.37||0.5093|TWO_SIDED|95.0|-0.96|0.48|||MMRM|||Week 8: Vasomotor Symptoms Score||0.48|-0.96|0.5093
72358920|NCT03192176|144229988|SUPERIORITY||LSMean difference|-1.6|STANDARD_ERROR_OF_MEAN|0.37|<|0.0001|TWO_SIDED|95.0|-2.33|-0.86||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 8: Vasomotor Symptoms Score||-0.86|-2.33|<0.0001
72358921|NCT03192176|144229988|SUPERIORITY||LSMean difference|-1.0|STANDARD_ERROR_OF_MEAN|0.36||0.009|TWO_SIDED|95.0|-1.67|-0.24||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 8: Vasomotor Symptoms Score||-0.24|-1.67|0.0090
72358922|NCT03192176|144229988|SUPERIORITY||LSMean difference|-1.1|STANDARD_ERROR_OF_MEAN|0.37||0.0024|TWO_SIDED|95.0|-1.84|-0.4||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|LSMean difference|||Week 4: Vasomotor Symptoms Score||-0.40|-1.84|0.0024
72358923|NCT03192176|144229988|SUPERIORITY||LSMean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.18||0.5497|TWO_SIDED|95.0|-0.47|0.25||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 8: Sexual Dysfunction Score||0.25|-0.47|0.5497
72358924|NCT03192176|144229988|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.18||0.0276|TWO_SIDED|95.0|-0.76|-0.04||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 8: Sexual Dysfunction Score||-0.04|-0.76|0.0276
72358925|NCT03192176|144229988|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.19||0.1274|TWO_SIDED|95.0|-0.65|0.08||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 8: Sexual Dysfunction Score||0.08|-0.65|0.1274
72358926|NCT03192176|144229988|SUPERIORITY||LSMean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.19||0.1865|TWO_SIDED|95.0|-0.61|0.12||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|LSMean difference|||Week 8: Sexual Dysfunction Score||0.12|-0.61|0.1865
72358927|NCT03192176|144229988|SUPERIORITY||LSMean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.18||0.1857|TWO_SIDED|95.0|-0.61|0.12||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 8: Sexual Dysfunction Score||0.12|-0.61|0.1857
72358928|NCT03192176|144229988|SUPERIORITY||LSMean difference|0.0|STANDARD_ERROR_OF_MEAN|0.18||0.8631|TWO_SIDED|95.0|-0.33|0.39||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 8: Sexual Dysfunction Score||0.39|-0.33|0.8631
72358929|NCT03192176|144229988|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.18||0.0304|TWO_SIDED|95.0|-0.75|-0.04||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 8: Sexual Dysfunction Score||-0.04|-0.75|0.0304
72358930|NCT03192176|144229988|SUPERIORITY||LSMean difference|-2.5|STANDARD_ERROR_OF_MEAN|1.63||0.1246|TWO_SIDED|95.0|-5.71|0.7||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 8: Total Score||0.70|-5.71|0.1246
72358931|NCT03192176|144229988|SUPERIORITY||LSMean difference|-3.0|STANDARD_ERROR_OF_MEAN|1.63||0.068|TWO_SIDED|95.0|-6.19|0.22||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 8: Total Score||0.22|-6.19|0.0680
72358932|NCT03192176|144229988|SUPERIORITY||LSMean difference|-3.0|STANDARD_ERROR_OF_MEAN|1.67||0.0729|TWO_SIDED|95.0|-6.28|0.28||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 8: Total Score||0.28|-6.28|0.0729
72358933|NCT03192176|144229988|SUPERIORITY||LSMean difference|-3.2|STANDARD_ERROR_OF_MEAN|1.66||0.0541|TWO_SIDED|95.0|-6.49|0.06||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 8: Total Score||0.06|-6.49|0.0541
72358934|NCT03192176|144229988|SUPERIORITY||LSMean difference|-0.6|STANDARD_ERROR_OF_MEAN|1.64||0.696|TWO_SIDED|95.0|-3.87|2.59||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 8: Total Score||2.59|-3.87|0.6960
72358935|NCT03192176|144229988|SUPERIORITY||LSMean difference|-0.1|STANDARD_ERROR_OF_MEAN|1.63||0.9725|TWO_SIDED|95.0|-3.27|3.15||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 8: Total Score||3.15|-3.27|0.9725
72358936|NCT03192176|144229988|SUPERIORITY||LSMean difference|-3.3|STANDARD_ERROR_OF_MEAN|1.63||0.0419|TWO_SIDED|95.0|-6.53|-0.12||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 8: Total Score||-0.12|-6.53|0.0419
72358937|NCT03192176|144229988|SUPERIORITY||LSMean difference|-1.7|STANDARD_ERROR_OF_MEAN|0.96||0.0794|TWO_SIDED|95.0|-3.57|0.2||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 12: Psychological Symptoms Score||0.20|-3.57|0.0794
72358938|NCT03192176|144229988|SUPERIORITY||LSMean difference|-1.5|STANDARD_ERROR_OF_MEAN|0.98||0.1153|TWO_SIDED|95.0|-3.47|0.38||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 12: Psychological Symptoms Score||0.38|-3.47|0.1153
72358939|NCT03192176|144229988|SUPERIORITY||-1.5|-1.5|STANDARD_ERROR_OF_MEAN|1.0||0.1334|TWO_SIDED|95.0|-3.47|0.46||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 12: Psychological Symptoms Score||0.46|-3.47|0.1334
72358940|NCT03192176|144229988|SUPERIORITY||LSMean difference|-0.9|STANDARD_ERROR_OF_MEAN|1.0||0.3457|TWO_SIDED|95.0|-2.93|1.03||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 12: Psychological Symptoms Score||1.03|-2.93|0.3457
72358941|NCT03192176|144229988|SUPERIORITY||LSMean difference|-1.1|STANDARD_ERROR_OF_MEAN|0.99||0.2607|TWO_SIDED|95.0|-3.07|0.83||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 12: Psychological Symptoms Score||0.83|-3.07|0.2607
72358942|NCT03192176|144229988|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.97||0.7816|TWO_SIDED|95.0|-2.18|1.64||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 12: Psychological Symptoms Score||1.64|-2.18|0.7816
72358943|NCT03192176|144229988|SUPERIORITY||LSMean difference|-1.6|STANDARD_ERROR_OF_MEAN|0.97||0.0955|TWO_SIDED|95.0|-3.54|0.29||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 12: Psychological Symptoms Score||0.29|-3.54|0.0955
72358944|NCT03192176|144229988|SUPERIORITY||LSMean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.5||0.2582|TWO_SIDED|95.0|-1.57|0.42||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 12: Physical Symptoms Score||0.42|-1.57|0.2582
72358945|NCT03192176|144229988|SUPERIORITY||LSMean difference|0.5|STANDARD_ERROR_OF_MEAN|0.52||0.3448|TWO_SIDED|95.0|-0.53|1.52||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 12: Physical Symptoms Score||1.52|-0.53|0.3448
72358946|NCT03192176|144229988|SUPERIORITY||LSMean difference|0.2|STANDARD_ERROR_OF_MEAN|0.53||0.6587|TWO_SIDED|95.0|-0.81|1.28||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 12: Physical Symptoms Score||1.28|-0.81|0.6587
72358947|NCT03192176|144229988|SUPERIORITY||LSMean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.53||0.8299|TWO_SIDED|95.0|-1.16|0.93||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 12: Physical Symptoms Score||0.93|-1.16|0.8299
72358948|NCT03192176|144229988|SUPERIORITY||LSMean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.53||0.8129|TWO_SIDED|95.0|-1.17|0.92||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 12: Physical Symptoms Score||0.92|-1.17|0.8129
72358949|NCT03192176|144229988|SUPERIORITY||LSMean Difference|0.6|STANDARD_ERROR_OF_MEAN|0.52||0.213|TWO_SIDED|95.0|-0.37|1.66||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 12: Physical Symptoms Score||1.66|-0.37|0.2130
72358950|NCT03192176|144229988|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.51||0.4131|TWO_SIDED|95.0|-1.42|0.59||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 12: Physical Symptoms Score||0.59|-1.42|0.4131
72358951|NCT03192176|144229988|SUPERIORITY||LSMean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.34||0.1273|TWO_SIDED|95.0|-1.2|0.15||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 12: Vasomotor Symptoms Score||0.15|-1.20|0.1273
72358952|NCT03192176|144229988|SUPERIORITY||LSMean difference|-1.0|STANDARD_ERROR_OF_MEAN|0.35||0.0046|TWO_SIDED|95.0|-1.69|-0.31||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 12: Vasomotor Symptoms Score||-0.31|-1.69|0.0046
72358953|NCT03192176|144229988|SUPERIORITY||LSMean difference|-1.5|STANDARD_ERROR_OF_MEAN|0.35|<|0.0001|TWO_SIDED|95.0|-2.19|-0.8||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 12: Vasomotor Symptoms Score||-0.80|-2.19|<0.0001
72358954|NCT03192176|144229988|SUPERIORITY||LSMean difference|-1.5|STANDARD_ERROR_OF_MEAN|0.36|<|0.0001|TWO_SIDED|95.0|-2.19|-0.78||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 12: Vasomotor Symptoms Score||-0.78|-2.19|<0.0001
72358955|NCT03192176|144229988|SUPERIORITY||LSMean difference|-0.8|STANDARD_ERROR_OF_MEAN|0.35||0.0333|TWO_SIDED|95.0|-1.45|-0.06||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 12: Vasomotor Symptoms Score||-0.06|-1.45|0.0333
72358956|NCT03192176|144229988|SUPERIORITY||LSMean difference|-0.7|STANDARD_ERROR_OF_MEAN|0.35||0.0423|TWO_SIDED|95.0|-1.39|-0.02||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 12: Vasomotor Symptoms Score||-0.02|-1.39|0.0423
72358957|NCT03192176|144229988|SUPERIORITY||LSMean difference|-0.8|STANDARD_ERROR_OF_MEAN|0.35||0.0208|TWO_SIDED|95.0|-1.49|-0.12||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 12: Vasomotor Symptoms Score||-0.12|-1.49|0.0208
72358958|NCT03192176|144229988|SUPERIORITY||LSMean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.19||0.3435|TWO_SIDED|95.0|-0.55|0.19||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 12: Sexual Dysfunction Score||0.19|-0.55|0.3435
72358959|NCT03192176|144229988|SUPERIORITY||LSMean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.19||0.0021|TWO_SIDED|95.0|-0.98|-0.22||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 12: Sexual Dysfunction Score||-0.22|-0.98|0.0021
72358960|NCT03192176|144229988|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.2||0.0408|TWO_SIDED|95.0|-0.79|-0.02||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 12: Sexual Dysfunction Score||-0.02|-0.79|0.0408
72358961|NCT03192176|144229988|SUPERIORITY||LSMean differencce|-0.3|STANDARD_ERROR_OF_MEAN|0.2||0.0911|TWO_SIDED|95.0|-0.73|0.05||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 12: Sexual Dysfunction Score||0.05|-0.73|0.0911
72358962|NCT03192176|144229988|SUPERIORITY||LSMean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.2||0.7891|TWO_SIDED|95.0|-0.44|0.33||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 12: Sexual Dysfunction Score||0.33|-0.44|0.7891
72358963|NCT03192176|144229988|SUPERIORITY||LSMean difference|0.0|STANDARD_ERROR_OF_MEAN|0.19||0.9973|TWO_SIDED|95.0|-0.38|0.38||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 12: Sexual Dysfunction Score||0.38|-0.38|0.9973
72358964|NCT03192176|144229988|SUPERIORITY||-0.1|-0.1|STANDARD_ERROR_OF_MEAN|0.19||0.6377|TWO_SIDED|95.0|-0.47|0.29||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 12: Sexual Dysfunction Score||0.29|-0.47|0.6377
72358965|NCT03192176|144229988|SUPERIORITY||LSMean difference|-2.8|STANDARD_ERROR_OF_MEAN|1.61||0.0862|TWO_SIDED|95.0|-5.95|0.4||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 12: Total Score||0.40|-5.95|0.0862
72358966|NCT03192176|144229988|SUPERIORITY||LSMean difference|-2.5|STANDARD_ERROR_OF_MEAN|1.65||0.1305|TWO_SIDED|95.0|-5.74|0.74||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 12: Total Score||0.74|-5.74|0.1305
72358967|NCT03192176|144229988|SUPERIORITY||LSMean difference|-3.0|STANDARD_ERROR_OF_MEAN|1.68||0.0707|TWO_SIDED|95.0|-6.34|0.26||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 12: Total Score||0.26|-6.34|0.0707
72358968|NCT03192176|144229988|SUPERIORITY||LSMean difference|-2.6|STANDARD_ERROR_OF_MEAN|1.68||0.1232|TWO_SIDED|95.0|-5.92|0.71||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 12: Total Score||0.71|-5.92|0.1232
72358969|NCT03192176|144229988|SUPERIORITY||LSMean difference|-1.9|STANDARD_ERROR_OF_MEAN|1.66||0.253|TWO_SIDED|95.0|-5.18|1.37||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 12: Total Score||1.37|-5.18|0.2530
72358970|NCT03192176|144229988|SUPERIORITY||LSMean difference|-0.2|STANDARD_ERROR_OF_MEAN|1.64||0.9133|TWO_SIDED|95.0|-3.4|3.04||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 12: Total Score||3.04|-3.40|0.9133
72358971|NCT03192176|144229988|SUPERIORITY||LSMean difference|-2.6|STANDARD_ERROR_OF_MEAN|1.63||0.1078|TWO_SIDED|95.0|-5.85|0.58||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 12: Total Score||0.58|-5.85|0.1078
72358972|NCT03192176|144229988|SUPERIORITY||LSMean differencce|-1.9|STANDARD_ERROR_OF_MEAN|1.08||0.0719|TWO_SIDED|95.0|-4.07|0.18||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 15: Psychological Symptoms Score||0.18|-4.07|0.0719
72358973|NCT03192176|144229988|SUPERIORITY||LSMean difference|-1.7|STANDARD_ERROR_OF_MEAN|1.09||0.1298|TWO_SIDED|95.0|-3.8|0.49||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 15: Psychological Symptoms Score||0.49|-3.80|0.1298
72358974|NCT03192176|144229988|SUPERIORITY||LSMean difference|-0.1|STANDARD_ERROR_OF_MEAN|1.11||0.9532|TWO_SIDED|95.0|-2.26|2.13||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 15: Psychological Symptoms Score||2.13|-2.26|0.9532
72358975|NCT03192176|144229988|SUPERIORITY||LSMean difference|0.4|STANDARD_ERROR_OF_MEAN|1.12||0.751|TWO_SIDED|95.0|-1.84|2.55||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 15: Psychological Symptoms Score||2.55|-1.84|0.7510
72358976|NCT03192176|144229988|SUPERIORITY||LSMean difference|-1.8|STANDARD_ERROR_OF_MEAN|1.11||0.112|TWO_SIDED|95.0|-3.95|0.42||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 15: Psychological Symptoms Score||0.42|-3.95|0.1120
72358977|NCT03192176|144229988|SUPERIORITY||LSMean difference|0.0|STANDARD_ERROR_OF_MEAN|1.1||0.9781|TWO_SIDED|95.0|-2.13|2.19||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 15: Psychological Symptoms Score||2.19|-2.13|0.9781
72358978|NCT03192176|144229988|SUPERIORITY||LSMean difference|-1.4|STANDARD_ERROR_OF_MEAN|1.1||0.206|TWO_SIDED|95.0|-3.57|0.77||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 15: Psychological Symptoms Score||0.77|-3.57|0.2060
72358979|NCT03192176|144229988|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.56||0.5332|TWO_SIDED|95.0|-1.46|0.76||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 15: Physical Symptoms Score||0.76|-1.46|0.5332
72358980|NCT03192176|144229988|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.57||0.4599|TWO_SIDED|95.0|-1.54|0.7||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 15: Physical Symptoms Score||0.70|-1.54|0.4599
72358981|NCT03192176|144229988|SUPERIORITY||LSMean difference|0.4|STANDARD_ERROR_OF_MEAN|0.58||0.4752|TWO_SIDED|95.0|-0.72|1.55||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 15: Physical Symptoms Score||1.55|-0.72|0.4752
72358982|NCT03192176|144229988|SUPERIORITY||LSMean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.58||0.9051|TWO_SIDED|95.0|-1.21|1.07||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 15: Physical Symptoms Score||1.07|-1.21|0.9051
72358983|NCT03192176|144229988|SUPERIORITY||LSMean difference|0.0|STANDARD_ERROR_OF_MEAN|0.58||0.9937|TWO_SIDED|95.0|-1.14|1.15||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 15: Physical Symptoms Score||1.15|-1.14|0.9937
72358984|NCT03192176|144229988|SUPERIORITY||LSMean difference|0.2|STANDARD_ERROR_OF_MEAN|0.57||0.6956|TWO_SIDED|95.0|-0.91|1.35||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 15: Physical Symptoms Score||1.35|-0.91|0.6956
72358985|NCT03192176|144229988|SUPERIORITY||LSMean difference|-0.7|STANDARD_ERROR_OF_MEAN|0.57||0.2302|TWO_SIDED|95.0|-1.81|0.44||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 15: Physical Symptoms Score||0.44|-1.81|0.2302
72358986|NCT03192176|144229988|SUPERIORITY||LSMean difference|-0.7|STANDARD_ERROR_OF_MEAN|0.46||0.1544|TWO_SIDED|95.0|-1.55|0.25||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 15: Vasomotor Symptoms Score||0.25|-1.55|0.1544
72358987|NCT03192176|144229988|SUPERIORITY||LSMean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.46||0.6847|TWO_SIDED|95.0|-1.1|0.72||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 15: Vasomotor Symptoms Score||0.72|-1.10|0.6847
72358988|NCT03192176|144229988|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.47||0.552|TWO_SIDED|95.0|-1.2|0.64||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 15: Vasomotor Symptoms Score||0.64|-1.20|0.5520
72358989|NCT03192176|144229988|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.47||0.3632|TWO_SIDED|95.0|-1.36|0.5||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 15: Vasomotor Symptoms Score||0.50|-1.36|0.3632
72358990|NCT03192176|144229988|SUPERIORITY||LSMean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.47||0.2828|TWO_SIDED|95.0|-1.43|0.42||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 15: Vasomotor Symptoms Score||0.42|-1.43|0.2828
72358991|NCT03192176|144229988|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.47||0.4702|TWO_SIDED|95.0|-1.24|0.58||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 15: Vasomotor Symptoms Score||0.58|-1.24|0.4702
72358992|NCT03192176|144229988|SUPERIORITY||LSMean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.47||0.8262|TWO_SIDED|95.0|-1.02|0.81||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 15: Vasomotor Symptoms Score||0.81|-1.02|0.8262
72358993|NCT03192176|144229988|SUPERIORITY||LSMean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.2||0.3152|TWO_SIDED|95.0|-0.6|0.19||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 15: Sexual Dysfunction Score||0.19|-0.60|0.3152
72358994|NCT03192176|144229988|SUPERIORITY||LSMean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.2||0.4399|TWO_SIDED|95.0|-0.56|0.24||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 15: Sexual Dysfunction Score||0.24|-0.56|0.4399
72358995|NCT03192176|144229988|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.21||0.1898|TWO_SIDED|95.0|-0.67|0.13||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 15: Sexual Dysfunction Score||0.13|-0.67|0.1898
72358996|NCT03192176|144229988|SUPERIORITY||LSMean difference|0.0|STANDARD_ERROR_OF_MEAN|0.21||0.9791|TWO_SIDED|95.0|-0.4|0.41||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 15: Sexual Dysfunction Score||0.41|-0.40|0.9791
72358997|NCT03192176|144229988|SUPERIORITY||LSMean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.21||0.3178|TWO_SIDED|95.0|-0.61|0.2||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 15: Sexual Dysfunction Score||0.20|-0.61|0.3178
72358998|NCT03192176|144229988|SUPERIORITY||LSMean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.2||0.4174|TWO_SIDED|95.0|-0.57|0.24||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 15: Sexual Dysfunction Score||0.24|-0.57|0.4174
72358999|NCT03192176|144229988|SUPERIORITY||LSMean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.2||0.249|TWO_SIDED|95.0|-0.63|0.16||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 15: Sexual Dysfunction Score||0.16|-0.63|0.2490
72359000|NCT03192176|144229988|SUPERIORITY||LSMean difference|-2.9|STANDARD_ERROR_OF_MEAN|1.87||0.1233|TWO_SIDED|95.0|-6.57|0.79||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 15: Total Score||0.79|-6.57|0.1233
72359001|NCT03192176|144229988|SUPERIORITY||LSMean difference|-2.0|STANDARD_ERROR_OF_MEAN|1.9||0.2858|TWO_SIDED|95.0|-5.76|1.7||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 15: Total Score||1.70|-5.76|0.2858
72359002|NCT03192176|144229988|SUPERIORITY||LSMean difference|-0.1|STANDARD_ERROR_OF_MEAN|1.93||0.9716|TWO_SIDED|95.0|-3.87|3.73||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 15: Total Score||3.73|-3.87|0.9716
72359003|NCT03192176|144229988|SUPERIORITY||LSMean difference|0.2|STANDARD_ERROR_OF_MEAN|1.93||0.9072|TWO_SIDED|95.0|-3.58|4.03||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 15: Total Score||4.03|-3.58|0.9072
72359004|NCT03192176|144229988|SUPERIORITY||LSMean difference|-2.3|STANDARD_ERROR_OF_MEAN|1.92||0.2334|TWO_SIDED|95.0|-6.07|1.49||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 15: Total Score||1.49|-6.07|0.2334
72359005|NCT03192176|144229988|SUPERIORITY||LSMean difference|0.0|STANDARD_ERROR_OF_MEAN|1.91||0.9859|TWO_SIDED|95.0|-3.79|3.72||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 15: Total Score||3.72|-3.79|0.9859
72359006|NCT03192176|144229988|SUPERIORITY||LSMean difference|-2.0|STANDARD_ERROR_OF_MEAN|1.9||0.287|TWO_SIDED|95.0|-5.77|1.72||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 15: Total Score||1.72|-5.77|0.2870
72359007|NCT03192176|144229989|SUPERIORITY||LSMean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.42||0.1632|TWO_SIDED|95.0|-1.41|0.24||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4: Vasomotor Mean Score||0.24|-1.41|0.1632
72359008|NCT03192176|144229989|SUPERIORITY||LSMean difference|-1.2|STANDARD_ERROR_OF_MEAN|0.42||0.0045|TWO_SIDED|95.0|-2.03|-0.38||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4: Vasomotor Mean Score||-0.38|-2.03|0.0045
72359009|NCT03192176|144229989|SUPERIORITY||LSMean difference|-1.6|STANDARD_ERROR_OF_MEAN|0.42||0.0002|TWO_SIDED|95.0|-2.43|-0.77||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4: Vasomotor Mean Score||-0.77|-2.43|0.0002
72359010|NCT03192176|144229989|SUPERIORITY||LSMean difference|-1.9|STANDARD_ERROR_OF_MEAN|0.42|<|0.0001|TWO_SIDED|95.0|-2.7|-1.02||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4: Vasomotor Mean Score||-1.02|-2.70|<0.0001
72359011|NCT03192176|144229989|SUPERIORITY||LSMean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.42||0.8569|TWO_SIDED|95.0|-0.91|0.76||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4: Vasomotor Mean Score||0.76|-0.91|0.8569
72359012|NCT03192176|144229989|SUPERIORITY||LSMean difference|-0.7|STANDARD_ERROR_OF_MEAN|0.42||0.111|TWO_SIDED|95.0|-1.49|0.15||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4: Vasomotor Mean Score||0.15|-1.49|0.1110
72359013|NCT03192176|144229989|SUPERIORITY||LSMean difference|-1.0|STANDARD_ERROR_OF_MEAN|0.42||0.0187|TWO_SIDED|95.0|-1.83|-0.17||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4: Vasomotor Mean Score||-0.17|-1.83|0.0187
72359014|NCT03192176|144229989|SUPERIORITY||LSMean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.28||0.4972|TWO_SIDED|95.0|-0.73|0.36||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4: Psychological Mean Score||0.36|-0.73|0.4972
72359015|NCT03192176|144229989|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.28||0.2568|TWO_SIDED|95.0|-0.86|0.23||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4: Psychological Mean Score||0.23|-0.86|0.2568
72359016|NCT03192176|144229989|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.28||0.2609|TWO_SIDED|95.0|-0.86|0.23||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4: Psychological Mean Score||0.23|-0.86|0.2609
72359017|NCT03192176|144229989|SUPERIORITY||LSMean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.28||0.4148|TWO_SIDED|95.0|-0.78|0.32||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4: Psychological Mean Score||0.32|-0.78|0.4148
72359018|NCT03192176|144229989|SUPERIORITY||LSMean difference|0.2|STANDARD_ERROR_OF_MEAN|0.28||0.5575|TWO_SIDED|95.0|-0.38|0.71||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4: Psychological Mean Score||0.71|-0.38|0.5575
72359019|NCT03192176|144229989|SUPERIORITY||LSMean difference|0.4|STANDARD_ERROR_OF_MEAN|0.28||0.1671|TWO_SIDED|95.0|-0.16|0.92||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4: Psychological Mean Score||0.92|-0.16|0.1671
72359020|NCT03192176|144229989|SUPERIORITY||LSMean difference|0.0|STANDARD_ERROR_OF_MEAN|0.28||0.9462|TWO_SIDED|95.0|-0.57|0.53||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4: Psychological Mean Score||0.53|-0.57|0.9462
72359021|NCT03192176|144229989|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.24||0.0699|TWO_SIDED|95.0|-0.91|0.04||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4: Physical Mean Score||0.04|-0.91|0.0699
72359022|NCT03192176|144229989|SUPERIORITY||LSMean difference|-0.7|STANDARD_ERROR_OF_MEAN|0.24||0.0056|TWO_SIDED|95.0|-1.15|-0.2||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4: Physical Mean Score||-0.20|-1.15|0.0056
72359023|NCT03192176|144229989|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.24||0.1117|TWO_SIDED|95.0|-0.86|0.09||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4: Physical Mean Score||0.09|-0.86|0.1117
72359024|NCT03192176|144229989|SUPERIORITY||LSMean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.24||0.0265|TWO_SIDED|95.0|-1.02|-0.06||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4: Physical Mean Score||-0.06|-1.02|0.0265
72359025|NCT03192176|144229989|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.24||0.1119|TWO_SIDED|95.0|-0.86|0.09||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4: Physical Mean Score||0.09|-0.86|0.1119
72359026|NCT03192176|144229989|SUPERIORITY||LSMean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.24||0.7607|TWO_SIDED|95.0|-0.54|0.4||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4: Physical Mean Score||0.40|-0.54|0.7607
72359027|NCT03192176|144229989|SUPERIORITY||LSMean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.24||0.0437|TWO_SIDED|95.0|-0.97|-0.01||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4: Physical Mean Score||-0.01|-0.97|0.0437
72359028|NCT03192176|144229989|SUPERIORITY||LSMean difference|-0.8|STANDARD_ERROR_OF_MEAN|0.35||0.0211|TWO_SIDED|95.0|-1.51|-0.12||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4: Sexual Mean Score||-0.12|-1.51|0.0211
72359029|NCT03192176|144229989|SUPERIORITY||LSMean difference|-1.1|STANDARD_ERROR_OF_MEAN|0.35||0.0017|TWO_SIDED|95.0|-1.82|-0.42||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4: Sexual Mean Score||-0.42|-1.82|0.0017
72359030|NCT03192176|144229989|SUPERIORITY||LSMean difference|-0.7|STANDARD_ERROR_OF_MEAN|0.35||0.0598|TWO_SIDED|95.0|-1.37|0.03||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4: Sexual Mean Score||0.03|-1.37|0.0598
72359031|NCT03192176|144229989|SUPERIORITY||LSMean differencce|-0.5|STANDARD_ERROR_OF_MEAN|0.36||0.1573|TWO_SIDED|95.0|-1.21|0.2||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4: Sexual Mean Score||0.20|-1.21|0.1573
72359032|NCT03192176|144229989|SUPERIORITY||LSMean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.36||0.7257|TWO_SIDED|95.0|-0.83|0.58||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4: Sexual Mean Score||0.58|-0.83|0.7257
72359033|NCT03192176|144229989|SUPERIORITY||LSMean difference|0.0|STANDARD_ERROR_OF_MEAN|0.35||0.9324|TWO_SIDED|95.0|-0.72|0.66||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4: Sexual Mean Score||0.66|-0.72|0.9324
72359034|NCT03192176|144229989|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.35||0.2172|TWO_SIDED|95.0|-1.14|0.26||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4: Sexual Mean Score||0.26|-1.14|0.2172
72359035|NCT03192176|144229989|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.23||0.0742|TWO_SIDED|95.0|-0.88|0.04||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4: Overall Mean Score||0.04|-0.88|0.0742
72359036|NCT03192176|144229989|SUPERIORITY||LSMean difference|-0.7|STANDARD_ERROR_OF_MEAN|0.24||0.0035|TWO_SIDED|95.0|-1.16|-0.23||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4: Overall Score||-0.23|-1.16|0.0035
72359037|NCT03192176|144229989|SUPERIORITY||LSMean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.24||0.0266|TWO_SIDED|95.0|-0.99|-0.06||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4: Overall Mean Score||-0.06|-0.99|0.0266
72359038|NCT03192176|144229989|SUPERIORITY||LSMean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.24||0.0124|TWO_SIDED|95.0|-1.06|-0.13||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4: Overall Mean Score||-0.13|-1.06|0.0124
72359039|NCT03192176|144229989|SUPERIORITY||LSMean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.24||0.4367|TWO_SIDED|95.0|-0.65|0.28||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4: Overall Mean Score||0.28|-0.65|0.4367
72359040|NCT03192176|144229989|SUPERIORITY||LSMean difference|0.0|STANDARD_ERROR_OF_MEAN|0.23||0.9318|TWO_SIDED|95.0|-0.48|0.44||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4: Overall Mean Score||0.44|-0.48|0.9318
72359041|NCT03192176|144229989|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.24||0.0714|TWO_SIDED|95.0|-0.89|0.04||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4: Overall Mean Score||0.04|-0.89|0.0714
72359042|NCT03192176|144229989|SUPERIORITY||LSMean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.42||0.2027|TWO_SIDED|95.0|-1.35|0.29||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8: Vasomotor Mean Score||0.29|-1.35|0.2027
72359043|NCT03192176|144229989|SUPERIORITY||LSMean difference|-1.3|STANDARD_ERROR_OF_MEAN|0.41||0.0013|TWO_SIDED|95.0|-2.16|-0.53||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8: Vasomotor Mean Score||-0.53|-2.16|0.0013
72359044|NCT03192176|144229989|SUPERIORITY||LSMean difference|-1.7|STANDARD_ERROR_OF_MEAN|0.42|<|0.0001|TWO_SIDED|95.0|-2.53|-0.87||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8: Vasomotor Mean Score||-0.87|-2.53|<0.0001
72359045|NCT03192176|144229989|SUPERIORITY||LSMean difference|-2.0|STANDARD_ERROR_OF_MEAN|0.42|<|0.0001|TWO_SIDED|95.0|-2.83|-1.16||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8: Vasomotor Mean Score||-1.16|-2.83|<0.0001
72359046|NCT03192176|144229989|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.42||0.3791|TWO_SIDED|95.0|-1.19|0.45||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8: Vasomotor Mean Score||0.45|-1.19|0.3791
72359047|NCT03192176|144229989|SUPERIORITY||LSMean difference|-1.0|STANDARD_ERROR_OF_MEAN|0.42||0.0211|TWO_SIDED|95.0|-1.78|-0.15||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8: Vasomotor Mean Score||-0.15|-1.78|0.0211
72359048|NCT03192176|144229989|SUPERIORITY||LSMean difference|-1.3|STANDARD_ERROR_OF_MEAN|0.42||0.0021|TWO_SIDED|95.0|-2.1|-0.47||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8: Vasomotor Mean Score||-0.47|-2.10|0.0021
72359049|NCT03192176|144229989|SUPERIORITY||LSMean difference|0.0|STANDARD_ERROR_OF_MEAN|0.26||0.889|TWO_SIDED|95.0|-0.55|0.48||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Wek 8: Psychological Mean Score||0.48|-0.55|0.8890
72359050|NCT03192176|144229989|SUPERIORITY||LSMean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.26||0.5568|TWO_SIDED|95.0|-0.67|0.36||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8: Psychological Mean Score||0.36|-0.67|0.5568
72359051|NCT03192176|144229989|SUPERIORITY||LSMean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.27||0.3989|TWO_SIDED|95.0|-0.75|0.3||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8: Psychological Mean Score||0.30|-0.75|0.3989
72359052|NCT03192176|144229989|SUPERIORITY||LSMean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.27||0.6094|TWO_SIDED|95.0|-0.66|0.39||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8: Psychological Mean Score||0.39|-0.66|0.6094
72359053|NCT03192176|144229989|SUPERIORITY||LSMean difference|0.2|STANDARD_ERROR_OF_MEAN|0.26||0.5229|TWO_SIDED|95.0|-0.35|0.69||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8: Psychological Mean Score||0.69|-0.35|0.5229
72359054|NCT03192176|144229989|SUPERIORITY||LSMean difference|0.2|STANDARD_ERROR_OF_MEAN|0.26||0.4409|TWO_SIDED|95.0|-0.31|0.72||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8: Psychological Mean Score||0.72|-0.31|0.4409
72359055|NCT03192176|144229989|SUPERIORITY||LSMean difference|0.1|STANDARD_ERROR_OF_MEAN|0.26||0.8062|TWO_SIDED|95.0|-0.45|0.58||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8: Psychological Mean Score||0.58|-0.45|0.8062
72359056|NCT03192176|144229989|SUPERIORITY||LSMean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.25||0.3663|TWO_SIDED|95.0|-0.71|0.26||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8: Physical Mean Score||0.26|-0.71|0.3663
72359057|NCT03192176|144229989|SUPERIORITY||LSMean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.25||0.0424|TWO_SIDED|95.0|-0.99|-0.02||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8: Physical Mean Score||-0.02|-0.99|0.0424
72359058|NCT03192176|144229989|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.25||0.1597|TWO_SIDED|95.0|-0.85|0.14||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8: Physical Mean Score||0.14|-0.85|0.1597
72359059|NCT03192176|144229989|SUPERIORITY||LSMean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.25||0.0595|TWO_SIDED|95.0|-0.97|0.02||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8: Physical Mean Score||0.02|-0.97|0.0595
72359060|NCT03192176|144229989|SUPERIORITY||LSMean differnce|-0.3|STANDARD_ERROR_OF_MEAN|0.25||0.2162|TWO_SIDED|95.0|-0.8|0.18||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8: Physical Symptoms Score||0.18|-0.80|0.2162
72359061|NCT03192176|144229989|SUPERIORITY||LSMean difference|0.0|STANDARD_ERROR_OF_MEAN|0.25||0.9833|TWO_SIDED|95.0|-0.49|0.48||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8: Physical Mean Score||0.48|-0.49|0.9833
72359062|NCT03192176|144229989|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.25||0.2034|TWO_SIDED|95.0|-0.81|0.17||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8: Physical Mean Score||0.17|-0.81|0.2034
72359063|NCT03192176|144229989|SUPERIORITY||LSMean difference|0.0|STANDARD_ERROR_OF_MEAN|0.35||0.9576|TWO_SIDED|95.0|-0.7|0.67||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8: Sexual Mean Score||0.67|-0.70|0.9576
72359064|NCT03192176|144229989|SUPERIORITY||LSMean difference|-0.7|STANDARD_ERROR_OF_MEAN|0.35||0.041|TWO_SIDED|95.0|-1.4|-0.03||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8: Sexual Mean Score||-0.03|-1.40|0.0410
72359065|NCT03192176|144229989|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.35||0.3961|TWO_SIDED|95.0|-1.0|0.4||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8: Sexual Mean Score||0.40|-1.00|0.3961
72359066|NCT03192176|144229989|SUPERIORITY||LSMean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.36||0.5012|TWO_SIDED|95.0|-0.94|0.46||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8: Sexual Mean Score||0.46|-0.94|0.5012
72359067|NCT03192176|144229989|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.35||0.2592|TWO_SIDED|95.0|-1.1|0.3||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8: Sexual Mean Score||0.30|-1.10|0.2592
72359068|NCT03192176|144229989|SUPERIORITY||LSMean difference|0.2|STANDARD_ERROR_OF_MEAN|0.35||0.6141|TWO_SIDED|95.0|-0.51|0.86||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8: Sexual Mean Score||0.86|-0.51|0.6141
72359069|NCT03192176|144229989|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.35||0.439|TWO_SIDED|95.0|-0.95|0.41||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8: Sexual Mean Score||0.41|-0.95|0.4390
72359070|NCT03192176|144229989|SUPERIORITY||LSMean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.23||0.4521|TWO_SIDED|95.0|-0.64|0.29||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8: Overall Mean Score||0.29|-0.64|0.4521
72359071|NCT03192176|144229989|SUPERIORITY||LSMean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.23||0.0257|TWO_SIDED|95.0|-0.99|-0.06||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8: Overall Mean Score||-0.06|-0.99|0.0257
72359072|NCT03192176|144229989|SUPERIORITY||LSMean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.24||0.0564|TWO_SIDED|95.0|-0.93|0.01||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8: Overall Mean Score||0.01|-0.93|0.0564
72359073|NCT03192176|144229989|SUPERIORITY||LSMean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.24||0.0293|TWO_SIDED|95.0|-0.99|-0.05||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Wek 8: Overall Mean Score||-0.05|-0.99|0.0293
72359074|NCT03192176|144229989|SUPERIORITY||LSMean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.24||0.3742|TWO_SIDED|95.0|-0.68|0.26||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8: Overall Mean Score||0.26|-0.68|0.3742
72359075|NCT03192176|144229989|SUPERIORITY||LSMean difference|0.0|STANDARD_ERROR_OF_MEAN|0.23||0.9106|TWO_SIDED|95.0|-0.49|0.44||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8: Overall Mean Score||0.44|-0.49|0.9106
72359076|NCT03192176|144229989|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.23||0.1844|TWO_SIDED|95.0|-0.78|0.15||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8: Overall Mean SCore||0.15|-0.78|0.1844
72359077|NCT03192176|144229989|SUPERIORITY||LSMean difference|-0.9|STANDARD_ERROR_OF_MEAN|0.41||0.0287|TWO_SIDED|95.0|-1.69|-0.09||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12: Vasomotor Mean Score||-0.09|-1.69|0.0287
72359078|NCT03192176|144229989|SUPERIORITY||LSMean difference|-1.2|STANDARD_ERROR_OF_MEAN|0.41||0.0028|TWO_SIDED|95.0|-2.05|-0.43||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12: Vasomotor Mean Score||-0.43|-2.05|0.0028
72359079|NCT03192176|144229989|SUPERIORITY||LSMean difference|-1.5|STANDARD_ERROR_OF_MEAN|0.42||0.0004|TWO_SIDED|95.0|-2.32|-0.67||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12: Vasomotor Mean Score||-0.67|-2.32|0.0004
72359080|NCT03192176|144229989|SUPERIORITY||LSMean difference|-2.0|STANDARD_ERROR_OF_MEAN|0.42|<|0.0001|TWO_SIDED|95.0|-2.87|-1.22||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12: Vasomotor Mean Score||-1.22|-2.87|<0.0001
72359081|NCT03192176|144229989|SUPERIORITY||LSMean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.42||0.1826|TWO_SIDED|95.0|-1.38|0.26||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12: Vasomotor Mean Score||0.26|-1.38|0.1826
72359082|NCT03192176|144229989|SUPERIORITY||LSMean difference|-1.0|STANDARD_ERROR_OF_MEAN|0.41||0.0178|TWO_SIDED|95.0|-1.79|-0.17||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12: Vasomotor Mean Score||-0.17|-1.79|0.0178
72359083|NCT03192176|144229989|SUPERIORITY||LSMean differnce|-1.2|STANDARD_ERROR_OF_MEAN|0.41||0.0025|TWO_SIDED|95.0|-2.06|-0.44||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12: Vasomotor Mean Score||-0.44|-2.06|0.0025
72359084|NCT03192176|144229989|SUPERIORITY||LSMean difference|0.0|STANDARD_ERROR_OF_MEAN|0.27||0.9163|TWO_SIDED|95.0|-0.55|0.5||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12: Psychological Mean Score||0.50|-0.55|0.9163
72359085|NCT03192176|144229989|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.27||0.1597|TWO_SIDED|95.0|-0.92|0.15||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12: Psychological Mean Score||0.15|-0.92|0.1597
72359086|NCT03192176|144229989|SUPERIORITY||LSMean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.28||0.4871|TWO_SIDED|95.0|-0.74|0.35||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12: Psychological Mean Score||0.35|-0.74|0.4871
72359087|NCT03192176|144229989|SUPERIORITY||LSMean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.28||0.5401|TWO_SIDED|95.0|-0.72|0.38||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12: Psychological Mean Score||0.38|-0.72|0.5401
72359088|NCT03192176|144229989|SUPERIORITY||LSMean difference|0.2|STANDARD_ERROR_OF_MEAN|0.28||0.3788|TWO_SIDED|95.0|-0.3|0.79||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12: Psychological Mean Score||0.79|-0.30|0.3788
72359089|NCT03192176|144229989|SUPERIORITY||0.28|0.2|STANDARD_ERROR_OF_MEAN|0.27||0.4541|TWO_SIDED|95.0|-0.33|0.74||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12: Psychological Mean Score||0.74|-0.33|0.4541
72359090|NCT03192176|144229989|SUPERIORITY||LSMean difference|0.0|STANDARD_ERROR_OF_MEAN|0.27||0.9233|TWO_SIDED|95.0|-0.51|0.56||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12: Psychological Mean Score||0.56|-0.51|0.9233
72359091|NCT03192176|144229989|SUPERIORITY||LSMean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.24||0.6043|TWO_SIDED|95.0|-0.61|0.35||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12: Physical Mean Score||0.35|-0.61|0.6043
72359092|NCT03192176|144229989|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.25||0.1781|TWO_SIDED|95.0|-0.82|0.15||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12: Physical Mean Score||0.15|-0.82|0.1781
72359093|NCT03192176|144229989|SUPERIORITY||LSMean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.25||0.5221|TWO_SIDED|95.0|-0.66|0.34||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12: Physical Mean Score||0.34|-0.66|0.5221
72359094|NCT03192176|144229989|SUPERIORITY||LSMean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.25||0.4744|TWO_SIDED|95.0|-0.68|0.32||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12: Physical Mean Score||0.32|-0.68|0.4744
72359095|NCT03192176|144229989|SUPERIORITY||LSMean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.25||0.5167|TWO_SIDED|95.0|-0.66|0.33||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12: Physical Mean Score||0.33|-0.66|0.5167
72359096|NCT03192176|144229989|SUPERIORITY||LSMean difference|0.2|STANDARD_ERROR_OF_MEAN|0.25||0.3441|TWO_SIDED|95.0|-0.25|0.72||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12: Physical Mean Score||0.72|-0.25|0.3441
72359097|NCT03192176|144229989|SUPERIORITY||LSMean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.25||0.5362|TWO_SIDED|95.0|-0.64|0.33||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12: Physical Mean Score||0.33|-0.64|0.5362
72359098|NCT03192176|144229989|SUPERIORITY||LSMean difference|0.0|STANDARD_ERROR_OF_MEAN|0.38||0.9349|TWO_SIDED|95.0|-0.78|0.71||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12: Sexual Mean Score||0.71|-0.78|0.9349
72359099|NCT03192176|144229989|SUPERIORITY||LSMean differencce|-1.0|STANDARD_ERROR_OF_MEAN|0.39||0.0084|TWO_SIDED|95.0|-1.78|-0.26||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12: Sexual Mean Score||-0.26|-1.78|0.0084
72359100|NCT03192176|144229989|SUPERIORITY||LSMean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.39||0.1212|TWO_SIDED|95.0|-1.38|0.16||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12: Sexual Mean Score||0.16|-1.38|0.1212
72359101|NCT03192176|144229989|SUPERIORITY||LSMean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.39||0.7709|TWO_SIDED|95.0|-0.89|0.66||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12: Sexual Mean Score||0.66|-0.89|0.7709
72359102|NCT03192176|144229989|SUPERIORITY||LSMean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.4||0.1667|TWO_SIDED|95.0|-1.33|0.23||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12: Sexual Mean Score||0.23|-1.33|0.1667
72359103|NCT03192176|144229989|SUPERIORITY||LSMean difference|0.0|STANDARD_ERROR_OF_MEAN|0.38||0.9213|TWO_SIDED|95.0|-0.72|0.79||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12: Sexual Mean Score||0.79|-0.72|0.9213
72359104|NCT03192176|144229989|SUPERIORITY||LSMean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.38||0.2315|TWO_SIDED|95.0|-1.21|0.29||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12: Sexual Mean Score||0.29|-1.21|0.2315
72359105|NCT03192176|144229989|SUPERIORITY||LSMean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.23||0.4731|TWO_SIDED|95.0|-0.63|0.29||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12: Overall Mean Score||0.29|-0.63|0.4731
72359106|NCT03192176|144229989|SUPERIORITY||LSMean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.24||0.031|TWO_SIDED|95.0|-0.98|-0.05||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12: Overall Mean Score||-0.05|-0.98|0.0310
72359107|NCT03192176|144229989|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.24||0.132|TWO_SIDED|95.0|-0.84|0.11||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12: Overall Mean Score||0.11|-0.84|0.1320
72359108|NCT03192176|144229989|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.24||0.1212|TWO_SIDED|95.0|-0.85|0.1||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12: Overall Mean Score||0.10|-0.85|0.1212
72359109|NCT03192176|144229989|SUPERIORITY||LSMean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.24||0.5689|TWO_SIDED|95.0|-0.62|0.34||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12: Overall Mean Score||0.34|-0.62|0.5689
72359110|NCT03192176|144229989|SUPERIORITY||0.1|0.1|STANDARD_ERROR_OF_MEAN|0.24||0.734|TWO_SIDED|95.0|-0.39|0.55||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12: Overall Mean Score||0.55|-0.39|0.7340
72359111|NCT03192176|144229989|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.24||0.2704|TWO_SIDED|95.0|-0.73|0.2||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12: Overall Mean Score||0.20|-0.73|0.2704
72359112|NCT03192176|144229989|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.48||0.561|TWO_SIDED|95.0|-1.24|0.67||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15: Vasomotor Mean Score||0.67|-1.24|0.5610
72359113|NCT03192176|144229989|SUPERIORITY||LSMean difference|0.1|STANDARD_ERROR_OF_MEAN|0.49||0.7966|TWO_SIDED|95.0|-0.83|1.09||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15: Vasomotor Mean Score||1.09|-0.83|0.7966
72359114|NCT03192176|144229989|SUPERIORITY||LSMean difference|0.4|STANDARD_ERROR_OF_MEAN|0.5||0.3965|TWO_SIDED|95.0|-0.56|1.4||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15: Vasomotor Mean Score||1.40|-0.56|0.3965
72359115|NCT03192176|144229989|SUPERIORITY||LSMean difference|0.1|STANDARD_ERROR_OF_MEAN|0.5||0.8189|TWO_SIDED|95.0|-0.87|1.1||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15: Vasomotor Mean Score||1.10|-0.87|0.8189
72359116|NCT03192176|144229989|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.5||0.5693|TWO_SIDED|95.0|-1.27|0.7||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12: Vasomotor Mean Score||0.70|-1.27|0.5693
72359117|NCT03192176|144229989|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.49||0.5217|TWO_SIDED|95.0|-1.29|0.65||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15: Vasomotor Mean Score||0.65|-1.29|0.5217
72359118|NCT03192176|144229989|SUPERIORITY||LSMean difference|0.5|STANDARD_ERROR_OF_MEAN|0.49||0.2988|TWO_SIDED|95.0|-0.46|1.48||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15: Vasomotor Mean Score||1.48|-0.46|0.2988
72359119|NCT03192176|144229989|SUPERIORITY||LSMean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.31||0.7957|TWO_SIDED|95.0|-0.69|0.53||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15: Psychological Mean Score||0.53|-0.69|0.7957
72359120|NCT03192176|144229989|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.31||0.254|TWO_SIDED|95.0|-0.97|0.26||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15: Psychological Mean Score||0.26|-0.97|0.2540
72359121|NCT03192176|144229989|SUPERIORITY||LSMean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.32||0.6956|TWO_SIDED|95.0|-0.75|0.5||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15: Psychological Mean Score||0.50|-0.75|0.6956
72359122|NCT03192176|144229989|SUPERIORITY||LSMean difference|0.1|STANDARD_ERROR_OF_MEAN|0.32||0.8694|TWO_SIDED|95.0|-0.57|0.68||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15: Psychological Mean Score||0.68|-0.57|0.8694
72359123|NCT03192176|144229989|SUPERIORITY||LSMean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.32||0.5047|TWO_SIDED|95.0|-0.84|0.41||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15: Psychological Mean Score||0.41|-0.84|0.5047
72359124|NCT03192176|144229989|SUPERIORITY||LSMean difference|0.1|STANDARD_ERROR_OF_MEAN|0.31||0.7515|TWO_SIDED|95.0|-0.52|0.71||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15: Psychological Mean Score||0.71|-0.52|0.7515
72359125|NCT03192176|144229989|SUPERIORITY||LSMean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.31||0.7818|TWO_SIDED|95.0|-0.7|0.53||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15: Psychological Mean Score||0.53|-0.70|0.7818
72359126|NCT03192176|144229989|SUPERIORITY||LSMean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.26||0.577|TWO_SIDED|95.0|-0.65|0.36||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15: Physical Mean Score||0.36|-0.65|0.5770
72359127|NCT03192176|144229989|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.26||0.1893|TWO_SIDED|95.0|-0.85|0.17||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15: Physical Mean Score||0.17|-0.85|0.1893
72359128|NCT03192176|144229989|SUPERIORITY||LSMean difference|0.3|STANDARD_ERROR_OF_MEAN|0.26||0.2997|TWO_SIDED|95.0|-0.25|0.79||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15: Physical Mean Score||0.79|-0.25|0.2997
72359129|NCT03192176|144229989|SUPERIORITY||LSMean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.26||0.7529|TWO_SIDED|95.0|-0.6|0.44||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15: Physical Mean Score||0.44|-0.60|0.7529
72359130|NCT03192176|144229989|SUPERIORITY||LSMean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.26||0.4173|TWO_SIDED|95.0|-0.73|0.31||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15: Physical Mean Score||0.31|-0.73|0.4173
72359131|NCT03192176|144229989|SUPERIORITY||LSMean difference|0.2|STANDARD_ERROR_OF_MEAN|0.26||0.4944|TWO_SIDED|95.0|-0.34|0.69||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15: Physical Mean Score||0.69|-0.34|0.4944
72359132|NCT03192176|144229989|SUPERIORITY||LSMean differencce|0.0|STANDARD_ERROR_OF_MEAN|0.26||0.9231|TWO_SIDED|95.0|-0.54|0.49||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15: Physical Mean Score||0.49|-0.54|0.9231
72359133|NCT03192176|144229989|SUPERIORITY||LSMean differencce|-0.3|STANDARD_ERROR_OF_MEAN|0.4||0.5112|TWO_SIDED|95.0|-1.04|0.52||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15: Sexual Mean Score||0.52|-1.04|0.5112
72359134|NCT03192176|144229989|SUPERIORITY||LSMean difference|-0.9|STANDARD_ERROR_OF_MEAN|0.4||0.03|TWO_SIDED|95.0|-1.66|-0.09||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15: Sexual Mean Score||-0.09|-1.66|0.0300
72359135|NCT03192176|144229989|SUPERIORITY||LSMean difference|-0.8|STANDARD_ERROR_OF_MEAN|0.41||0.0634|TWO_SIDED|95.0|-1.57|0.04||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15: Sexual Mean Score||0.04|-1.57|0.0634
72359136|NCT03192176|144229989|SUPERIORITY||LSMean difference|0.0|STANDARD_ERROR_OF_MEAN|0.41||0.9406|TWO_SIDED|95.0|-0.78|0.84||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15: Sexual Mean Score||0.84|-0.78|0.9406
72359137|NCT03192176|144229989|SUPERIORITY||LSMean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.41||0.1168|TWO_SIDED|95.0|-1.46|0.16||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15: Sexual Mean Score||0.16|-1.46|0.1168
72359138|NCT03192176|144229989|SUPERIORITY||LSMean difference|0.0|STANDARD_ERROR_OF_MEAN|0.4||0.9937|TWO_SIDED|95.0|-0.79|0.8||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15: Sexual Mean Score||0.80|-0.79|0.9937
72359139|NCT03192176|144229989|SUPERIORITY||LSMean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.4||0.1858|TWO_SIDED|95.0|-1.32|0.26||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15: Sexual Mean Score||0.26|-1.32|0.1858
72359140|NCT03192176|144229989|SUPERIORITY||LSMean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.26||0.5765|TWO_SIDED|95.0|-0.65|0.36||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15: Overall Mean Score||0.36|-0.65|0.5765
72359141|NCT03192176|144229989|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.26||0.1848|TWO_SIDED|95.0|-0.86|0.17||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15: Overall Mean Score||0.17|-0.86|0.1848
72359142|NCT03192176|144229989|SUPERIORITY||LSMean difference|0.1|STANDARD_ERROR_OF_MEAN|0.26||0.7299|TWO_SIDED|95.0|-0.43|0.61||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15: Overall Mean Score||0.61|-0.43|0.7299
72359143|NCT03192176|144229989|SUPERIORITY||LSMean difference|0.0|STANDARD_ERROR_OF_MEAN|0.26||0.9415|TWO_SIDED|95.0|-0.54|0.5||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15: Overall Mean Score||0.50|-0.54|0.9415
72359144|NCT03192176|144229989|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.27||0.2742|TWO_SIDED|95.0|-0.82|0.23||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15: Overall Mean Score||0.23|-0.82|0.2742
72359145|NCT03192176|144229989|SUPERIORITY||LSMean difference|0.1|STANDARD_ERROR_OF_MEAN|0.26||0.6946|TWO_SIDED|95.0|-0.41|0.62||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15: Overall Mean Score||0.62|-0.41|0.6946
72359146|NCT03192176|144229989|SUPERIORITY||LSMean difference|0.0|STANDARD_ERROR_OF_MEAN|0.26||0.9442|TWO_SIDED|95.0|-0.53|0.5||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15: Overall Mean Score||0.50|-0.53|0.9442
72359147|NCT05108246|144229994|SUPERIORITY|||||||0.001||||||P-value is calculated.|Wilcoxon (Mann-Whitney)|||Change in balance was assessed by calculating a change score between pre-test and end point scores for balance. Change scores were then compared using Mann-Whitney U test and reported as Median (Interquartile range).||||.001
72359148|NCT05108246|144229994|SUPERIORITY|||||||0.003||||||P-value is calculated.|Wilcoxon (Mann-Whitney)|||Change in balance was assessed by calculating a change score between pre-test and end point scores for balance. Change scores were then compared using Mann-Whitney U test and reported as Median (Interquartile range).||||.003
72359149|NCT00117637|144230007|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.88||||0.5|TWO_SIDED|95.0|0.61|1.27||The log rank test is stratified by region (western Europe, Eastern Europe, USA) and by Motzer risk category (low, intermediate).|Log Rank|||The study was planned to show a 80% improvement in PFS for the group treated with Sorafenib compared to the group treated with Interferon, with a 80% power and a 2-sided type I error of 5%||1.27|0.61|0.50
72359150|NCT00117637|144230008|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.882||||0.469|TWO_SIDED|95.0|0.628|1.239||The log rank test is stratified by region (western Europe, Eastern Europe, USA) and by Motzer risk category (low, intermediate).|Log Rank|||The study was planned to show a 80% improvement in PFS for the group treated with Sorafenib compared to the group treated with Interferon, with a 80% power and a 2-sided type I error of 5%||1.239|0.628|0.469
72359151|NCT00117637|144230009|SUPERIORITY_OR_OTHER|||||||0.006||95.0||||The Cochran-Mantel-Haenszel statistics was stratified by region and Motzer risk category.|Cochran-Mantel-Haenszel|||||||0.006
72359152|NCT00117637|144230010|SUPERIORITY_OR_OTHER|||||||0.0004||95.0||||the Cochran-Mantel-Haenszel statistics was stratified by region and Motzer risk category.|Cochran-Mantel-Haenszel|||||||0.0004
72359153|NCT00117637|144230012|SUPERIORITY_OR_OTHER|||||||0.022||95.0|||||Mixed Models Analysis|||The least square (LS) means have been adjusted according to the stratification factors (geographical region, Motzer score at baseline) and using the baseline respiratory score as covariate.||||0.022
72359154|NCT00117637|144230014|SUPERIORITY_OR_OTHER|||||||0.015||95.0|||||Mixed Models Analysis|||The least square (LS) means have been adjusted according to the stratification factors (geographical region, Motzer score at baseline) and using the baseline respiratory score as covariate.||||0.015
72359155|NCT00117637|144230016|SUPERIORITY_OR_OTHER|||||||0.073||95.0|||||Mixed Models Analysis|||The least square (LS) means have been adjusted according to the stratification factors (geographical region, Motzer score at baseline).||||0.073
72359156|NCT00117637|144230018|SUPERIORITY_OR_OTHER|||||||0.067||95.0|||||Mixed Models Analysis|||The least square (LS) means have been adjusted according to the stratification factors (geographical region, Motzer score at baseline).||||0.067
72359157|NCT00117637|144230019|SUPERIORITY_OR_OTHER|||||||0.005||95.0|||||Mixed Models Analysis|||The least square (LS) means have been adjusted according to the stratification factors (geographical region, Motzer score at baseline).||||0.005
72359158|NCT00117637|144230020|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||Mixed Models Analysis|||The least square (LS) means have been adjusted according to the stratification factors (geographical region, Motzer score at baseline).||||0.001
72359159|NCT00117637|144230021|SUPERIORITY_OR_OTHER|||||||0.019||95.0|||||Mixed Models Analysis|||The least square (LS) means have been adjusted according to the stratification factors (geographical region, Motzer score at baseline).||||0.019
72359160|NCT00117637|144230030|SUPERIORITY_OR_OTHER|||||||0.014||95.0|||||Log Rank|||||||0.014
72359161|NCT00702468|144230062|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.335||||0.013|TWO_SIDED|90.0|0.162|0.691|||Chi-squared|||||0.691|0.162|0.013
72359162|NCT00702468|144230063|SUPERIORITY_OR_OTHER_LEGACY||Estimated treatment difference|-0.21||||0.72|TWO_SIDED|90.0|-1.22|0.79|||ANCOVA||Negative difference indicates the comparison is in favour of Sativex|||0.79|-1.22|0.720
72359163|NCT00702468|144230064|SUPERIORITY_OR_OTHER_LEGACY||Treatment difference|0.53||||0.86|TWO_SIDED|90.0|-4.68|5.74|||ANCOVA|||||5.74|-4.68|0.86
72359164|NCT00702468|144230066|SUPERIORITY_OR_OTHER_LEGACY||Slope|-1.78||||0.81|TWO_SIDED|90.0|-14.52|10.96|||ANCOVA||Negative difference indicates the comparison is in favour of Sativex|It is important to emphasise that only four placebo subjects were included in the analysis and 11 of the Sativex subjects - this sample size is too small for a meaningful comparison between treatments. The reason for not including some of the data in this analysis is that a number of the subjects who withdrew early from the study restarted their own Sativex before the assessment was done.||10.96|-14.52|0.81
72359165|NCT00702468|144230067|SUPERIORITY_OR_OTHER_LEGACY||treatment difference|-0.64||||0.271|TWO_SIDED|90.0|-1.6|0.33|||ANCOVA||A negative difference indicates the comparison is in favour of Sativex|||0.33|-1.60|0.271
72359166|NCT00702468|144230068|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|4.562||||0.017|TWO_SIDED|90.0|1.585|13.997|||Regression, Logistic|||||13.997|1.585|0.017
72359167|NCT00702468|144230069|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|18.55||||0.0011|TWO_SIDED|90.0|3.942|118.773|||Regression, Logistic|||||118.773|3.942|0.0011
72359168|NCT00702468|144230070|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|3.444||||0.1151|TWO_SIDED|90.0|0.948|13.718|||Regression, Logistic|||||13.718|0.948|0.1151
72359169|NCT00300755|144230088|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||Within group analysis of final week change from baseline.||||<0.001
72359170|NCT00300755|144230088|SUPERIORITY_OR_OTHER|||||||0.063|||||||t-test, 2 sided|||Within group analysis of final week change from baseline.||||0.063
72359171|NCT00300755|144230088|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||Within group analysis of final week change from baseline.||||< 0.001
72359172|NCT00300755|144230088|SUPERIORITY_OR_OTHER|||||||0.004|||||||ANCOVA|Analysis with treatment group and baseline age as fixed effects, and baseline GERD symptom score and baseline antacid use as covariates||Between group analysis of final week change from baseline.||||0.004
72359173|NCT00300755|144230088|SUPERIORITY_OR_OTHER|||||||0.082|||||||ANCOVA|Analysis with treatment group and baseline age as fixed effects, and baseline GERD symptom score and baseline antacid use as covariates||Between group analysis of final week change from baseline.||||0.082
72359174|NCT00300755|144230088|SUPERIORITY_OR_OTHER|||||||0.217|||||||ANCOVA|Analysis with treatment group and baseline age as fixed effects, and baseline GERD symptom score and baseline antacid use as covariates||Between group analysis of final week change from baseline.||||0.217
72359175|NCT00300755|144230089|SUPERIORITY_OR_OTHER|||||||0.002|||||||t-test, 2 sided|||Within group analysis of final week change from baseline for symptom Vomiting/regurgitation.||||0.002
72359176|NCT00300755|144230089|SUPERIORITY_OR_OTHER|||||||0.033|||||||t-test, 2 sided|||Within group analysis of final week change from baseline for symptom Vomiting/regurgitation.||||0.033
72359177|NCT00300755|144230089|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||Within group analysis of final week change from baseline for symptom Choking/gagging.||||<0.001
72359178|NCT00300755|144230089|SUPERIORITY_OR_OTHER|||||||0.002|||||||t-test, 2 sided|||Within group analysis of final week change from baseline for symptom Choking/gagging.||||0.002
72359179|NCT00300755|144230089|SUPERIORITY_OR_OTHER|||||||0.009|||||||t-test, 2 sided|||Within group analysis of final week change from baseline for symptom Refusal to eat.||||0.009
72359180|NCT00300755|144230089|SUPERIORITY_OR_OTHER|||||||0.004|||||||t-test, 2 sided|||Within group analysis of final week change from baseline for symptom Difficulty swallowing.||||0.004
72359181|NCT00300755|144230089|SUPERIORITY_OR_OTHER|||||||0.044|||||||t-test, 2 sided|||Within group analysis of final week change from baseline for symptom Difficulty swallowing.||||0.044
72359182|NCT00300755|144230089|SUPERIORITY_OR_OTHER|||||||0.002|||||||t-test, 2 sided|||Within group analysis of final week change from baseline for symptom Abdominal/belly pain.||||0.002
72359183|NCT00300755|144230089|SUPERIORITY_OR_OTHER|||||||0.026|||||||t-test, 2 sided|||Within group analysis of final week change from baseline for symptom Abdominal/belly pain.||||0.026
72359184|NCT00300755|144230089|SUPERIORITY_OR_OTHER|||||||0.026|||||||t-test, 2 sided|||Within group analysis of final week change from baseline for symptom Abdominal/belly pain.||||0.026
72359185|NCT00300755|144230090|SUPERIORITY_OR_OTHER|||||||0.004|||||||t-test, 2 sided|||Within group analysis of final week change from baseline for Cough without cold.||||0.004
72359186|NCT00300755|144230090|SUPERIORITY_OR_OTHER|||||||0.047|||||||t-test, 2 sided|||Within group analysis of final week change from baseline for Noisy breathing.||||0.047
72359187|NCT03192826|144230092|EQUIVALENCE|The SPSS statistical package version 23.0 (Statistical Package for the Social Sciences, version 23.0, SSPS Inc. Chicago, IL, USA) was used for statistical analysis.|Mean Difference (Final Values)|0.05|||<|0.05|TWO_SIDED||||||ANOVA|Repeated measures ANOVA was used to compare parametric values with Bonferroni post hoc test for within group comparisons.|the reported p-value was calculated, and is not attempting to indicate the threshold for statistical significance|||||<0.05
72359188|NCT03192826|144230093|EQUIVALENCE|The SPSS statistical package version 23.0 (Statistical Package for the Social Sciences, version 23.0, SSPS Inc. Chicago, IL, USA) was used for statistical analysis.|Mean Difference (Final Values)|0.05|||<|0.05|TWO_SIDED||||||ANOVA|Repeated measures ANOVA was used to compare parametric values with Bonferroni post hoc test for within group comparisons.|the reported p-value was calculated, and is not attempting to indicate the threshold for statistical significance|||||<0.05
72359189|NCT03192826|144230094|EQUIVALENCE|The SPSS statistical package version 23.0 (Statistical Package for the Social Sciences, version 23.0, SSPS Inc. Chicago, IL, USA) was used for statistical analysis.|Mean Difference (Final Values)|0.05|||<|0.05|TWO_SIDED||||||ANOVA|Repeated measures ANOVA was used to compare parametric values with Bonferroni post hoc test for within group comparisons.|the reported p-value was calculated, and is not attempting to indicate the threshold for statistical significance|||||<0.05
72359190|NCT03192826|144230095|EQUIVALENCE|The SPSS statistical package version 23.0 (Statistical Package for the Social Sciences, version 23.0, SSPS Inc. Chicago, IL, USA) was used for statistical analysis.|Mean Difference (Final Values)|0.05|||<|0.05|TWO_SIDED||||||ANOVA|Repeated measures ANOVA was used to compare parametric values with Bonferroni post hoc test for within group comparisons.|the reported p-value was calculated, and is not attempting to indicate the threshold for statistical significance|||||<0.05
72359191|NCT02694744|144230096|OTHER||||||||||||||||||If the 95% confidence interval for the w/out food Arm overlapped the confidence interval for the w/ food Arm, the study will conclude that there is no evidence of a statistically significant difference between treatment arms.|||
72359192|NCT02694744|144230097|SUPERIORITY||Mean Difference (Final Values)|0.03||||0.7893|TWO_SIDED|95.0|-0.17|0.22|||ANCOVA|||Estimation of mean change in serum potassium from Baseline to week 4.||0.22|-0.17|0.7893
72359193|NCT02174731|144230125|NON_INFERIORITY|Non-inferiority of roxadustat versus epoetin alfa was declared if the lower bound of the 95% confidence interval (CI) of the difference between roxadustat and epoetin alfa exceeded -0.75. Non-inferiority p-value is 1-sided.|Least Square Mean Difference|0.09|STANDARD_ERROR_OF_MEAN|0.044|<|0.001|TWO_SIDED|95.0|0.01|0.18|||ANCOVA||Difference between groups (roxadustat minus Epoetin alfa) in LS mean changes.|||0.18|0.01|<0.001
72359194|NCT02174731|144230126|NON_INFERIORITY|Non-inferiority of roxadustat versus epoetin alfa was declared if the lower bound of the 95% CI of the difference between roxadustat and epoetin alfa exceeded -0.75. Non-inferiority p-value is 1-sided.|Least Square Mean Difference|0.14|STANDARD_ERROR_OF_MEAN|0.056|<|0.001|TWO_SIDED|95.0|0.03|0.25|||MMRM||Difference between groups (roxadustat minus Epoetin alfa) in LS mean change.|||0.25|0.03|<0.001
72359195|NCT02174731|144230127|NON_INFERIORITY|Non-inferiority of roxadustat versus epoetin alfa was declared if the lower bound of the 95% CI of the difference between roxadustat and epoetin alfa exceeded -0.15. Non-inferiority p-value is 1-sided.|Least Square Mean Difference|0.03|STANDARD_ERROR_OF_MEAN|0.013|<|0.001|TWO_SIDED|95.0|0.0|0.05|||ANCOVA||Difference between groups (roxadustat minus Epoetin alfa) in LS mean.|||0.05|0.00|<0.001
72359196|NCT02174731|144230128|NON_INFERIORITY|Non-inferiority of roxadustat versus epoetin alfa was declared if the lower bound of the 95% CI of the difference between roxadustat and epoetin alfa exceeded -0.15. Non-inferiority p-value is 1-sided.|Least Square Mean Difference|0.02|STANDARD_ERROR_OF_MEAN|0.014|<|0.001|TWO_SIDED|95.0|-0.01|0.05|||ANCOVA||Difference between groups (roxadustat minus Epoetin alfa) in LS mean.|||0.05|-0.01|<0.001
72359197|NCT02174731|144230129|SUPERIORITY|Superiority was also declared as the lower bound of the 95% CI exceeded 0 and p-value was lower than 0.05.|Least Square Mean Difference|-0.33|STANDARD_ERROR_OF_MEAN|0.03|<|0.001|TWO_SIDED|95.0|-0.39|-0.27|||ANCOVA||Difference between groups (roxadustat minus Epoetin alfa) in LS mean.|||-0.27|-0.39|<0.001
72359198|NCT02174731|144230130|NON_INFERIORITY|Non-inferiority of roxadustat versus epoetin alfa was declared if the lower bound of the 95% CI of the difference between roxadustat and epoetin alfa exceeded -0.75. Non-inferiority p-value is 1-sided.|Least Square Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|0.081|<|0.001|TWO_SIDED|95.0|0.04|0.36|||ANCOVA|MAR-based multiple imputation.|Difference between groups (roxadustat minus Epoetin alfa) in LS mean.|||0.36|0.04|<0.001
72359199|NCT02174731|144230131|SUPERIORITY||||||<|0.0001|||||||Wilcoxon Rank Sum Test|||||||<0.0001
72359200|NCT02174731|144230132|NON_INFERIORITY|Non-inferiority of roxadustat versus epoetin alfa was declared if the upper bound of the HR 95% CI of the difference between roxadustat and epoetin alfa was less than or equal to 1.8. Non-inferiority p-value is 1-sided. The CIs were from Wald and ties were calculated using the Efron method.|Hazard Ratio (HR)|0.83|||<|0.001|TWO_SIDED|95.0|0.64|1.07|||Regression, Cox|||||1.07|0.64|<0.001
72359201|NCT00660192|144230207|SUPERIORITY_OR_OTHER|||||||0.0347|TWO_SIDED||||||t-test, 2 sided|||||||0.0347
72359202|NCT00660192|144230208|SUPERIORITY_OR_OTHER|||||||0.03|TWO_SIDED||||||Fisher Exact|||||||0.0300
72359203|NCT02734693|144230212|SUPERIORITY||Mean Difference (Final Values)|-5.18|STANDARD_ERROR_OF_MEAN|1.2|<|0.001|TWO_SIDED|95.0|-7.565|-2.802|||ANCOVA|||Least squares means, SEs, effect sizes, 95% CIs, and p-values were generated using an ANCOVA model, with treatment (dasotraline/placebo), mean SKAMP-CS at baseline, and site as fixed effects. The dasotraline 6 mg/day treatment arm was discontinued in Version 3.00 of the protocol.||-2.802|-7.565|<0.001
72359204|NCT02734693|144230215|SUPERIORITY||Mean Difference (Final Values)|23.67|STANDARD_ERROR_OF_MEAN|7.395||0.002|TWO_SIDED|95.0|8.987|38.346|||ANCOVA|||Least squares means, SEs, effect sizes, 95% CIs, and p-values were generated using an ANCOVA model, with treatment (dasotraline/placebo), PERMP at baseline, and site as fixed effects. The dasotraline 6 mg/day treatment arm was discontinued in Version 3.00 of the protocol||38.346|8.987|0.002
72359205|NCT02734693|144230215|SUPERIORITY||Mean Difference (Net)|24.05|STANDARD_ERROR_OF_MEAN|7.389||0.002|TWO_SIDED|95.0|9.381|38.714|||ANCOVA|||Least squares means, SEs, effect sizes, 95% CIs, and p-values were generated using an ANCOVA model, with treatment (dasotraline/placebo), PERMP at baseline, and site as fixed effects. The dasotraline 6 mg/day treatment arm was discontinued in Version 3.00 of the protocol||38.714|9.381|0.002
72359206|NCT02898454|144230229|SUPERIORITY||LS mean difference|-0.87|||<|0.0001|TWO_SIDED|95.0|-1.03|-0.71|||ANCOVA|||Data was analyzed using a hybrid method of the worst-observation carried forward (WOCF) and multiple imputation (MI). The imputed completed data were analyzed by fitting ANCOVA model with the corresponding baseline, treatment group, asthma/NSAID-ERD status, prior surgery history, and regions as covariates. Statistical inference obtained from all imputed data was combined using Rubin's rule.||-0.71|-1.03|<0.0001
72359207|NCT02898454|144230230|SUPERIORITY||LS mean difference|-1.8|||<|0.0001|TWO_SIDED|95.0|-2.1|-1.51|||ANCOVA|||Data was analyzed using a hybrid method of the WOCF and MI. The imputed completed data were analyzed by fitting an ANCOVA model with corresponding baseline value, treatment group, asthma/NSAID-ERD status, prior surgery history, and regions as covariates. Statistical inference obtained from all imputed data was combined using Rubin's rule.||-1.51|-2.10|<0.0001
72359208|NCT02898454|144230231|SUPERIORITY|Hierarchical testing procedure was used to control type I error. For regions outside of Japan, this first secondary endpoint was not tested unless both co-primary endpoints were significant at the 0.05 level. Hierarchical testing continued only when previous endpoint was statistically significant. For Japan submission, LMK was instead a co-primary endpoint which also had to be met before secondary endpoints were tested in the hierarchy. Last endpoint in hierarchy is Week 52 SNOT-22.|LS mean difference|-5.13|||<|0.0001|TWO_SIDED|95.0|-5.8|-4.46||Threshold for significance at 0.05 level.|ANCOVA|||Data were analyzed using a hybrid method of the WOCF and MI. The imputed completed data were analyzed by fitting an ANCOVA model with corresponding baseline, treatment group, asthma/NSAID-ERD status, prior surgery history, and regions as covariates. Statistical inference obtained from all imputed data was combined using Rubin's rule.||-4.46|-5.80|<0.0001
72429363|NCT03226457|144369705|OTHER|Details of the power calculation are published in the Circulation, DOI: 10.1161/CIRCULATIONAHA.120.048739|||||=|0.005||||||(calculated)|ANCOVA|||"Details on the statistical analysis are published in the Circulation, DOI: 10.1161/CIRCULATIONAHA.120.048739~Analyses were performed on the primary and secondary measures comparing empagliflozin versus placebo and assessed by 2-way analysis of covariance correcting for treatment order, baseline value, and any percentage change in furosemide dose at the visit. Data for continuous outcome measures were assessed for normality before analysis."||||= 0.005
72359209|NCT02898454|144230232|SUPERIORITY|Testing according to the hierarchical testing procedure (only performed if previous outcome measures were statistically significant).|LS mean difference|-2.44|||<|0.0001|TWO_SIDED|95.0|-2.87|-2.02||Threshold for significance at 0.05 level.|ANCOVA|||Data were analyzed using a hybrid method of the WOCF and MI. The imputed completed data were analyzed by fitting an ANCOVA model with corresponding baseline value, treatment group, asthma/NSAID-ERD status, prior surgery history, and regions as covariates. Statistical inference obtained from all imputed data was combined using Rubin's rule.||-2.02|-2.87|<0.0001
72359210|NCT02898454|144230233|SUPERIORITY|Testing according to the hierarchical testing procedure (only performed if previous outcome measures were statistically significant).|LS mean difference|10.52|||<|0.0001|TWO_SIDED|95.0|8.98|12.07||Threshold for significance at 0.05 level.|ANCOVA|||Data were analyzed using a hybrid method of the WOCF and MI. The imputed completed data were analyzed by fitting an ANCOVA model with corresponding baseline value, treatment group, asthma/NSAID-ERD status, prior surgery history, and regions as covariates. Statistical inference obtained from all imputed data was combined using Rubin's rule.||12.07|8.98|<0.0001
72359211|NCT02898454|144230234|SUPERIORITY|Testing according to the hierarchical testing procedure (only performed if previous outcome measures were statistically significant).|LS mean difference|-0.98|||<|0.0001|TWO_SIDED|95.0|-1.15|-0.81||Threshold for significance at 0.05 level.|ANCOVA|||Data were analyzed using a hybrid method of the WOCF and MI. The imputed completed data were analyzed by fitting an ANCOVA model with corresponding baseline value, treatment group, asthma/NSAID-ERD status, prior surgery history, and regions as covariates. Statistical inference obtained from all imputed data was combined using Rubin's rule.||-0.81|-1.15|<0.0001
72359212|NCT02898454|144230235|SUPERIORITY|Testing according to the hierarchical testing procedure (only performed if previous outcome measures were statistically significant).|LS mean difference|-17.36|||<|0.0001|TWO_SIDED|95.0|-20.87|-13.85||Threshold for significance at 0.05 level.|ANCOVA|||Data were analyzed using a hybrid method of the WOCF and MI. The imputed completed data were analyzed by fitting an ANCOVA model with corresponding baseline value, treatment group, asthma/NSAID-ERD status, prior surgery history, and regions as covariates. Statistical inference obtained from all imputed data was combined using Rubin's rule.||-13.85|-20.87|<0.0001
72359213|NCT02898454|144230236|SUPERIORITY|Testing according to the hierarchical testing procedure (only performed if previous outcome measures were statistically significant).|LS mean difference|-2.21|||<|0.0001|TWO_SIDED|95.0|-2.59|-1.83||Threshold for significance at 0.05 level.|ANCOVA||Dupilumab 300 mg q2w then q4w vs. Placebo|Data were analyzed using a hybrid method of the WOCF and MI. The imputed completed data were analyzed by fitting an ANCOVA model with corresponding baseline, treatment group, asthma/NSAID-ERD status, prior surgery history, and regions as covariates. Statistical inference obtained from all imputed data was combined using Rubin's rule.||-1.83|-2.59|<0.0001
72359214|NCT02898454|144230236|SUPERIORITY|Testing according to the hierarchical testing procedure (only performed if previous outcome measures were statistically significant).|LS mean difference|-2.41|||<|0.0001|TWO_SIDED|95.0|-2.78|-2.03||Threshold for significance at 0.05 level.|ANCOVA||Dupilumab 300 mg q2w vs. Placebo|Data were analyzed using a hybrid method of the WOCF and MI. The imputed completed data were analyzed by fitting an ANCOVA model with corresponding baseline, treatment group, asthma/NSAID-ERD status, prior surgery history, and regions as covariates. Statistical inference obtained from all imputed data was combined using Rubin's rule.||-2.03|-2.78|<0.0001
72359215|NCT02898454|144230237|SUPERIORITY|Testing according to the hierarchical testing procedure (only performed if previous outcome measures were statistically significant).|LS mean difference|-1.11|||<|0.0001|TWO_SIDED|95.0|-1.3|-0.92||Threshold for significance at 0.05 level.|ANCOVA||Dupilumab 300 mg q2w then q4w vs. Placebo|Data were analyzed using a hybrid method of the WOCF and MI. The imputed completed data were analyzed by fitting an ANCOVA model with corresponding baseline, treatment group, asthma/NSAID-ERD status, prior surgery history, and regions as covariates. Statistical inference obtained from all imputed data was combined using Rubin's rule.||-0.92|-1.30|<0.0001
72359216|NCT02898454|144230237|SUPERIORITY|Testing according to the hierarchical testing procedure (only performed if previous outcome measures were statistically significant).|LS mean difference|-0.99|||<|0.0001|TWO_SIDED|95.0|-1.18|-0.8||Threshold for significance at 0.05 level.|ANCOVA||Dupilumab 300 mg q2w vs. Placebo|Data were analyzed using a hybrid method of the WOCF and MI. The imputed completed data were analyzed by fitting an ANCOVA model with corresponding baseline, treatment group, asthma/NSAID-ERD status, prior surgery history, and regions as covariates. Statistical inference obtained from all imputed data was combined using Rubin's rule.||-0.80|-1.18|<0.0001
72359217|NCT02898454|144230238|SUPERIORITY|Testing according to the hierarchical testing procedure (only performed if previous outcome measures were statistically significant).|LS mean difference|-21.36|||<|0.0001|TWO_SIDED|95.0|-25.45|-17.27||Threshold for significance at 0.05 level.|ANCOVA||Dupilumab 300 mg q2w then q4w vs. Placebo|Data were analyzed using a hybrid method of the WOCF and MI. The imputed completed data were analyzed by fitting an ANCOVA model with corresponding baseline, treatment group, asthma/NSAID-ERD status, prior surgery history, and regions as covariates. Statistical inference obtained from all imputed data was combined using Rubin's rule.||-17.27|-25.45|<0.0001
72359218|NCT02898454|144230238|SUPERIORITY|Testing according to the hierarchical testing procedure (only performed if previous outcome measures were statistically significant).|LS mean difference|-20.73|||<|0.0001|TWO_SIDED|95.0|-24.81|-16.65||Threshold for significance at 0.05 level.|ANCOVA||Dupilumab 300 mg q2w vs. Placebo|Data were analyzed using a hybrid method of the WOCF and MI. The imputed completed data were analyzed by fitting an ANCOVA model with corresponding baseline, treatment group, asthma/NSAID-ERD status, prior surgery history, and regions as covariates. Statistical inference obtained from all imputed data was combined using Rubin's rule.||-16.65|-24.81|<0.0001
72359219|NCT01601535|144230281|OTHER|||||||0.14||||||MYCN Amplified vs. MYCN not Amplified|Fisher Exact|||||||0.14
72359220|NCT01601535|144230281|OTHER|||||||0.21|||||||Fisher Exact|MYCN Amplified or Myc Positive vs. MYCN Non-amplified and Myc Negative||||||0.21
72359221|NCT01601535|144230281|OTHER|||||||1|||||||Fisher Exact|Aurora A protein Positive vs. Aurora A protein Negative||||||1.0
72359222|NCT01601535|144230282|OTHER|||||||0.094||||||UGT1A1 6\\6 vs. UGT1A1 6\\7 vs. UGT1A1 7\\7|Fisher Exact|||||||0.094
72359223|NCT01601535|144230282|OTHER|||||||0.63||||||UGT1A1 6\\6 vs. UGT1A1 6\\7 vs. UGT1A1 7\\7|Fisher Exact|||||||0.63
72359224|NCT01601535|144230283|OTHER|||||||0.9||||||AurkA Codon 31 Summary H vs. AurkA Codon 31 Summary V vs. AurkA Codon 31 Summary W|Fisher Exact|||||||0.90
72359225|NCT01601535|144230283|OTHER|||||||1||||||AurkA Codon 57 Summary H vs. AurkA Codon 57 Summary W|Fisher Exact|||||||1.0
72359226|NCT00647296|144230289|SUPERIORITY||Slope|-0.606|STANDARD_ERROR_OF_MEAN|0.408||0.1385|TWO_SIDED|95.0|-1.41|0.19|||Mixed Models Analysis||placebo minus active treatment arm, positive direction represents better outcome.|||0.19|-1.41|0.1385
72359227|NCT00647296|144230289|SUPERIORITY||Slope|0.113|STANDARD_ERROR_OF_MEAN|0.39||0.7718|TWO_SIDED|95.0|-0.65|0.88|||Mixed Models Analysis||placebo minus active treatment arm, positive direction represents better outcome.|||0.88|-0.65|0.7718
72359228|NCT00647296|144230289|SUPERIORITY||Slope|0.401|STANDARD_ERROR_OF_MEAN|0.397||0.3146|TWO_SIDED|95.0|-0.38|1.18|||Mixed Models Analysis||placebo minus active treatment arm, positive direction represents better outcome.|||1.18|-0.38|0.3146
72359229|NCT00647296|144230290|SUPERIORITY||Slope|0.395|STANDARD_ERROR_OF_MEAN|1.536||0.7973|TWO_SIDED|95.0|-2.61|3.4|||Mixed Models Analysis||placebo minus active treatment arm, positive direction represents a better outcome.|||3.40|-2.61|0.7973
72359230|NCT00647296|144230290|SUPERIORITY||Slope|2.009|STANDARD_ERROR_OF_MEAN|1.47||0.1732|TWO_SIDED|95.0|-0.87|4.89|||Mixed Models Analysis||placebo minus active treatment arm, positive direction represents better outcome.|||4.89|-0.87|0.1732
72359231|NCT00647296|144230290|SUPERIORITY||Slope|0.451|STANDARD_ERROR_OF_MEAN|1.497||0.7635|TWO_SIDED|95.0|-2.48|3.39|||Mixed Models Analysis||placebo minus active treatment arm, positive direction represents a better outcome.|||3.39|-2.48|0.7635
72359232|NCT00647296|144230301|SUPERIORITY||Slope|0.263|STANDARD_ERROR_OF_MEAN|0.19||0.1772|TWO_SIDED|95.0|-0.12|0.64|||Mixed Models Analysis||50 mg/day minus 150 mg/day arm, negative direction represents worse outcome.|||0.64|-0.12|0.1772
72359233|NCT00647296|144230302|SUPERIORITY||Slope|-0.615|STANDARD_ERROR_OF_MEAN|0.73||0.4025|TWO_SIDED|95.0|-2.06|0.83|||Mixed Models Analysis||50 mg/day minus 300 mg/day treatment arm, negative direction represents worse outcome.|||0.83|-2.06|0.4025
72359234|NCT01787461|144230303|SUPERIORITY_OR_OTHER||Least Squares (LS) Mean Difference|0.14||||0.358|TWO_SIDED|95.0|-0.16|0.44|||ANOVA|||Change at Week 24: Analysis was performed using an analysis of variance (ANOVA) model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||0.44|-0.16|0.358
72359235|NCT01787461|144230304|SUPERIORITY_OR_OTHER||Weighted Gamma Statistic|0.037||||0.568|TWO_SIDED|95.0|-0.19|0.27|||Cochran-Mantel-Haenszel|||Analysis was performed using Cochran-Mantel-Haenszel (CMH) test with modified ridit scores, controlling for Glogau classification of photoaging and site.||0.27|-0.19|0.568
72359236|NCT01787461|144230305|SUPERIORITY_OR_OTHER||LS Mean Difference|0.04||||0.797|TWO_SIDED|95.0|-0.25|0.33|||ANOVA|||Change at Week 12: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||0.33|-0.25|0.797
72359237|NCT01787461|144230306|SUPERIORITY_OR_OTHER||LS Mean Difference|0.01||||0.965|TWO_SIDED|95.0|-0.29|0.3|||ANOVA|||Change at Week 12, Fine lines/wrinkles (Periocular area): Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||0.30|-0.29|0.965
72359238|NCT01787461|144230306|SUPERIORITY_OR_OTHER||LS Mean Difference|0.05||||0.674|TWO_SIDED|95.0|-0.2|0.3|||ANOVA|||Change at Week 12, Fine lines/wrinkles (Perioral area): Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||0.30|-0.20|0.674
72359239|NCT01787461|144230306|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.02||||0.916|TWO_SIDED|95.0|-0.35|0.32|||ANOVA|||Change at Week 12, Under eye dark circles or bags: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||0.32|-0.35|0.916
72359240|NCT01787461|144230306|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.02||||0.915|TWO_SIDED|95.0|-0.39|0.35|||ANOVA|||Change at Week 12, Mottled hyperpigmentation: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||0.35|-0.39|0.915
72359241|NCT01787461|144230306|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.07||||0.672|TWO_SIDED|95.0|-0.4|0.26|||ANOVA|||Change at Week 12, Sallowness/yellowing: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||0.26|-0.40|0.672
72359242|NCT01787461|144230306|SUPERIORITY_OR_OTHER||LS Mean Difference|0.08||||0.655|TWO_SIDED|95.0|-0.27|0.43|||ANOVA|||Change at Week 12, Roughness/texture: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||0.43|-0.27|0.655
72359243|NCT01787461|144230306|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1||||0.561|TWO_SIDED|95.0|-0.23|0.43|||ANOVA|||Change at Week 24, Fine lines/wrinkles(Periocular area): Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||0.43|-0.23|0.561
72359244|NCT01787461|144230306|SUPERIORITY_OR_OTHER||LS Mean Difference|0.13||||0.356|TWO_SIDED|95.0|-0.14|0.4|||ANOVA|||Change at Week 24, Fine lines/wrinkles(Perioral area): Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||0.40|-0.14|0.356
72359245|NCT01787461|144230306|SUPERIORITY_OR_OTHER||LS Mean Difference|0.08||||0.669|TWO_SIDED|95.0|-0.28|0.43|||ANOVA|||Change at Week 24, Under eye dark circles or bags: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||0.43|-0.28|0.669
72359246|NCT01787461|144230306|SUPERIORITY_OR_OTHER||LS Mean Difference|0.01||||0.954|TWO_SIDED|95.0|-0.32|0.34|||ANOVA|||Change at Week 24, Mottled hyperpigmentation: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||0.34|-0.32|0.954
72359247|NCT01787461|144230306|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.06||||0.684|TWO_SIDED|95.0|-0.34|0.22|||ANOVA|||Change at Week 24, Sallowness/yellowing: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||0.22|-0.34|0.684
72359248|NCT01787461|144230306|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.02||||0.886|TWO_SIDED|95.0|-0.35|0.3|||ANOVA|||Change at Week 24, Roughness/texture: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||0.30|-0.35|0.886
72359249|NCT01787461|144230307|SUPERIORITY_OR_OTHER||LS Mean Difference|0.02||||0.901|TWO_SIDED|95.0|-0.33|0.37|||ANOVA|||Change at Week 12, Decolletage-Crepyness: Analysis was performed using an ANOVA model with treatment, Glogau cassification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||0.37|-0.33|0.901
72359250|NCT01787461|144230307|SUPERIORITY_OR_OTHER||LS Mean Difference|0.14||||0.399|TWO_SIDED|95.0|-0.19|0.47|||ANOVA|||Change at Week 12, Decolletage-Mottled Hyperpigmentation: Analysis was performed using an ANOVA model with treatment, Glogau cassification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||0.47|-0.19|0.399
72359251|NCT01787461|144230307|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.03||||0.875|TWO_SIDED|95.0|-0.38|0.32|||ANOVA|||Change at Week 12, Back of Hands-Crepyness: Analysis was performed using an ANOVA model with treatment, Glogau cassification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||0.32|-0.38|0.875
72359252|NCT01787461|144230307|SUPERIORITY_OR_OTHER||LS Mean Difference|0.43||||0.005|TWO_SIDED|95.0|0.13|0.73|||ANOVA|||Change at Week 12, Back of Hands-Mottled Hyperpigmentation: Analysis was performed using an ANOVA model with treatment, Glogau cassification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||0.73|0.13|0.005
72359253|NCT01787461|144230307|SUPERIORITY_OR_OTHER||LS Mean Difference|0.03||||0.876|TWO_SIDED|95.0|-0.33|0.38|||ANOVA|||Change at Week 24, Decolletage-Crepyness: Analysis was performed using an ANOVA model with treatment, Glogau cassification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||0.38|-0.33|0.876
72359254|NCT01787461|144230307|SUPERIORITY_OR_OTHER||LS Mean Difference|0.05||||0.789|TWO_SIDED|95.0|-0.29|0.38|||ANOVA|||Change at Week 24, Decolletage-Mottled Hyperpigmentation: Analysis was performed using an ANOVA model with treatment, Glogau cassification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||0.38|-0.29|0.789
72359255|NCT01787461|144230307|SUPERIORITY_OR_OTHER||LS Mean Difference|0.04||||0.901|TWO_SIDED|95.0|-0.31|0.38|||ANOVA|||Change at Week 24, Back of Hands- Crepyness: Analysis was performed using an ANOVA model with treatment, Glogau cassification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||0.38|-0.31|0.901
72359256|NCT01787461|144230307|SUPERIORITY_OR_OTHER||LS Mean Difference|0.38||||0.027|TWO_SIDED|95.0|0.04|0.72|||ANOVA|||Change at Week 24, Back of Hands - Mottled Hyperpigmentation: Analysis was performed using an ANOVA model with treatment, Glogau cassification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||0.72|0.04|0.027
72359257|NCT01787461|144230308|SUPERIORITY_OR_OTHER||Weighted Gamma Statistic|0.083||||0.688|TWO_SIDED|95.0|-0.1|0.27|||Cochran-Mantel-Haenszel|||Improvement Week 12, Overall appearance of facial skin: Analysis was performed using CMH test with modified ridit scores, controlling for Glogau Classification of Photoaging, site, and baseline.||0.27|-0.10|0.688
72359258|NCT01787461|144230308|SUPERIORITY_OR_OTHER||Weighted Gamma Statistic|0.121||||0.445|TWO_SIDED|95.0|-0.08|0.33|||Cochran-Mantel-Haenszel|||Improvement Week 12, Fine lines/wrinkles: Analysis was performed using CMH test with modified ridit scores, controlling for Glogau Classification of Photoaging, site, and baseline.||0.33|-0.08|0.445
72359259|NCT01787461|144230308|SUPERIORITY_OR_OTHER||Weighted Gamma Statistic|0.205||||0.318|TWO_SIDED|95.0|0.01|0.4|||Cochran-Mantel-Haenszel|||Improvement Week 12, Under eye dark circles or bags: Analysis was performed using CMH test with modified ridit scores, controlling for Glogau Classification of Photoaging, site, and baseline.||0.40|0.01|0.318
72359260|NCT01787461|144230308|SUPERIORITY_OR_OTHER||Weighted Gamma Statistic|-0.012||||0.633|TWO_SIDED|95.0|-0.15|0.12|||Cochran-Mantel-Haenszel|||Improvement Week 12, Discoloration: Analysis was performed using CMH test with modified ridit scores, controlling for Glogau Classification of Photoaging, site, and baseline.||0.12|-0.15|0.633
72359261|NCT01787461|144230308|SUPERIORITY_OR_OTHER||Weighted Gamma Statistic|-0.018||||0.996|TWO_SIDED|95.0|-0.23|0.19|||Cochran-Mantel-Haenszel|||Improvement Week 12, Complexion/Glow: Analysis was performed using CMH test with modified ridit scores, controlling for Glogau Classification of Photoaging, site, and baseline.||0.19|-0.23|0.996
72359262|NCT01787461|144230308|SUPERIORITY_OR_OTHER||Weighted Gamma Statistic|0.059||||0.432|TWO_SIDED|95.0|-0.13|0.25|||Cochran-Mantel-Haenszel|||Improvement Week 12, Smoothness: Analysis was performed using CMH test with modified ridit scores, controlling for Glogau Classification of Photoaging, site, and baseline.||0.25|-0.13|0.432
72359263|NCT01787461|144230308|SUPERIORITY_OR_OTHER||Weighted Gamma Statistic|0.03||||0.833|TWO_SIDED|95.0|-0.13|0.19|||Cochran-Mantel-Haenszel|||Improvement Week 24, Overall appearance of facial skin: Analysis was performed using CMH test with modified ridit scores, controlling for Glogau Classification of Photoaging, site, and baseline.||0.19|-0.13|0.833
72359264|NCT01787461|144230308|SUPERIORITY_OR_OTHER||Weighted Gamma Statistic|0.226||||0.171|TWO_SIDED|95.0|0.06|0.39|||Cochran-Mantel-Haenszel|||Improvement Week 24, Fine lines/wrinkles: Analysis was performed using CMH test with modified ridit scores, controlling for Glogau Classification of Photoaging, site, and baseline.||0.39|0.06|0.171
72359265|NCT01787461|144230308|SUPERIORITY_OR_OTHER||Weighted Gamma Statistic|-0.02||||0.796|TWO_SIDED|95.0|-0.16|0.12|||Cochran-Mantel-Haenszel|||Improvement Week 24, Under eye dark circles or bags: Analysis was performed using CMH test with modified ridit scores, controlling for Glogau Classification of Photoaging, site, and baseline.||0.12|-0.16|0.796
72359266|NCT01787461|144230308|SUPERIORITY_OR_OTHER||Weighted Gamma Statistic|-0.033||||0.942|TWO_SIDED|95.0|-0.23|0.16|||Cochran-Mantel-Haenszel|||Improvement Week 24, Discoloration: Analysis was performed using CMH test with modified ridit scores, controlling for Glogau Classification of Photoaging, site, and baseline.||0.16|-0.23|0.942
72359267|NCT01787461|144230308|SUPERIORITY_OR_OTHER||Weighted Gamma Statistic|0.118||||0.405|TWO_SIDED|95.0|-0.05|0.28|||Cochran-Mantel-Haenszel|||Improvement Week 24, Complexion/Glow: Analysis was performed using CMH test with modified ridit scores, controlling for Glogau Classification of Photoaging, site, and baseline.||0.28|-0.05|0.405
72359268|NCT01787461|144230308|SUPERIORITY_OR_OTHER||Weighted Gamma Statistic|0.061||||0.687|TWO_SIDED|95.0|-0.14|0.26|||Cochran-Mantel-Haenszel|||Improvement Week 24, Smoothness: Analysis was performed using CMH test with modified ridit scores, controlling for Glogau Classification of Photoaging, site, and baseline.||0.26|-0.14|0.687
72359269|NCT01787461|144230309|SUPERIORITY_OR_OTHER||Weighted Gamma Statistic|0.384||||0.017|TWO_SIDED|95.0|0.23|0.54|||Cochran-Mantel-Haenszel|||Improvement Week 12, Decolletage-Overall: Analysis was performed using CMH test with modified ridit scores, controlling for Glogau Classification of Photoaging, site, and baseline.||0.54|0.23|0.017
72359270|NCT01787461|144230309|SUPERIORITY_OR_OTHER||Weighted Gamma Statistic|0.248||||0.073|TWO_SIDED|95.0|0.09|0.4|||Cochran-Mantel-Haenszel|||Improvement Week 12, Decolletage-Wrinkling/crinkling: Analysis was performed using CMH test with modified ridit scores, controlling for Glogau Classification of Photoaging, site, and baseline.||0.40|0.09|0.073
72359271|NCT01787461|144230309|SUPERIORITY_OR_OTHER||Weighted Gamma Statistic|0.057||||0.117|TWO_SIDED|95.0|-0.11|0.22|||Cochran-Mantel-Haenszel|||Improvement Week 12, Decolletage-Discoloration: Analysis was performed using CMH test with modified ridit scores, controlling for Glogau Classification of Photoaging, site, and baseline.||0.22|-0.11|0.117
72359272|NCT01787461|144230309|SUPERIORITY_OR_OTHER||Weighted Gamma Statistic|-0.096||||0.662|TWO_SIDED|95.0|-0.31|0.12|||Cochran-Mantel-Haenszel|||Improvement Week 12, Back of Hands-Overall: Analysis was performed using CMH test with modified ridit scores, controlling for Glogau Classification of Photoaging, site, and baseline.||0.12|-0.31|0.662
72359273|NCT01787461|144230309|SUPERIORITY_OR_OTHER||Weighted Gamma Statistic|0.1||||0.373|TWO_SIDED|95.0|-0.05|0.25|||Cochran-Mantel-Haenszel|||Improvement Week 12, Back of Hands - Fine lines/wrinkles: Analysis was performed using CMH test with modified ridit scores, controlling for Glogau Classification of Photoaging, site, and baseline.||0.25|-0.05|0.373
72359274|NCT01787461|144230309|SUPERIORITY_OR_OTHER||Weighted Gamma Statistic|-0.031||||0.294|TWO_SIDED|95.0|-0.19|0.12|||Cochran-Mantel-Haenszel|||Improvement Week 12, Back of Hands - Discoloration: Analysis was performed using CMH test with modified ridit scores, controlling for Glogau Classification of Photoaging, site, and baseline.||0.12|-0.19|0.294
72359275|NCT01787461|144230309|SUPERIORITY_OR_OTHER||Weighted Gamma Statistic|-0.035||||0.857|TWO_SIDED|95.0|-0.2|0.13|||Cochran-Mantel-Haenszel|||Improvement Week 12, Body - Dryness Overall: Analysis was performed using CMH test with modified ridit scores, controlling for Glogau Classification of Photoaging, site, and baseline.||0.13|-0.20|0.857
72359276|NCT01787461|144230309|SUPERIORITY_OR_OTHER||Weighted Gamma Statistic|0.206||||0.088|TWO_SIDED|95.0|0.02|0.39|||Cochran-Mantel-Haenszel|||Improvement Week 24, Decolletage-Overall: Analysis was performed using CMH test with modified ridit scores, controlling for Glogau Classification of Photoaging, site, and baseline.||0.39|0.02|0.088
72359277|NCT01787461|144230309|SUPERIORITY_OR_OTHER||Weighted Gamma Statistic|0.193||||0.11|TWO_SIDED|95.0|-0.02|0.41|||Cochran-Mantel-Haenszel|||Improvement Week 24, Decolletage-Wrinkling/crinkling: Analysis was performed using CMH test with modified ridit scores, controlling for Glogau Classification of Photoaging, site, and baseline.||0.41|-0.02|0.110
72359278|NCT01787461|144230309|SUPERIORITY_OR_OTHER||Weighted Gamma Statistic|0.205||||0.112|TWO_SIDED|95.0|0.07|0.34|||Cochran-Mantel-Haenszel|||Improvement Week 24, Decolletage-Discoloration: Analysis was performed using CMH test with modified ridit scores, controlling for Glogau Classification of Photoaging, site, and baseline.||0.34|0.07|0.112
72359279|NCT01787461|144230309|SUPERIORITY_OR_OTHER||Weighted Gamma Statistic|0.003||||0.614|TWO_SIDED|95.0|-0.13|0.13|||Cochran-Mantel-Haenszel|||Improvement Week 24, Back of Hands-Overall: Analysis was performed using CMH test with modified ridit scores, controlling for Glogau Classification of Photoaging, site, and baseline.||0.13|-0.13|0.614
72359280|NCT01787461|144230309|SUPERIORITY_OR_OTHER||Weighted Gamma Statistic|-0.011||||0.693|TWO_SIDED|95.0|-0.18|0.16|||Cochran-Mantel-Haenszel|||Improvement Week 24, Back of Hands - Fine lines/wrinkles: Analysis was performed using CMH test with modified ridit scores, controlling for Glogau Classification of Photoaging, site, and baseline.||0.16|-0.18|0.693
72359281|NCT01787461|144230309|SUPERIORITY_OR_OTHER||Weighted Gamma Statistic|0.079||||0.762|TWO_SIDED|95.0|-0.06|0.22|||Cochran-Mantel-Haenszel|||Improvement Week 24, Back of Hands - Discoloration: Analysis was performed using CMH test with modified ridit scores, controlling for Glogau Classification of Photoaging, site, and baseline.||0.22|-0.06|0.762
72359282|NCT01787461|144230309|SUPERIORITY_OR_OTHER||Weighted Gamma Statistic|-0.013||||0.662|TWO_SIDED|95.0|-0.16|0.13|||Cochran-Mantel-Haenszel|||Improvement Week 24, Body - Dryness Overall: Analysis was performed using CMH test with modified ridit scores, controlling for Glogau Classification of Photoaging, site, and baseline.||0.13|-0.16|0.662
72359283|NCT01787461|144230310|SUPERIORITY_OR_OTHER||LS Mean Difference|3.93||||0.587|TWO_SIDED|95.0|-10.32|18.18|||ANOVA|||Change at Week 6, Left Cheek: Analysis was performed using ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||18.18|-10.32|0.587
72359284|NCT01787461|144230310|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.08||||0.814|TWO_SIDED|95.0|-14.49|12.32|||ANOVA|||Change at Week 12, Left Cheek: Analysis was performed using ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||12.32|-14.49|0.814
72359285|NCT01787461|144230310|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.57||||0.453|TWO_SIDED|95.0|-16.14|8.99|||ANOVA|||Change at Week 18, Left Cheek: Analysis was performed using ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||8.99|-16.14|0.453
72359286|NCT01787461|144230310|SUPERIORITY_OR_OTHER||LS Mean Difference|-9.16||||0.191|TWO_SIDED|95.0|-22.92|4.61|||ANOVA|||Change at Week 24, Left Cheek: Analysis was performed using ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||4.61|-22.92|0.191
72359287|NCT01787461|144230310|SUPERIORITY_OR_OTHER||LS Mean Difference|2.61||||0.685|TWO_SIDED|95.0|-10.07|15.28|||ANOVA|||Change at Week 6, Left Inner Arm: Analysis was performed using ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||15.28|-10.07|0.685
72359288|NCT01787461|144230310|SUPERIORITY_OR_OTHER||LS Mean Difference|5.74||||0.48|TWO_SIDED|95.0|-11.67|23.15|||ANOVA|||Change at Week 12, Left Inner Arm: Analysis was performed using ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||23.15|-11.67|0.480
72359289|NCT01787461|144230310|SUPERIORITY_OR_OTHER||LS Mean Difference|-5.98||||0.299|TWO_SIDED|95.0|-17.29|5.34|||ANOVA|||Change at Week 18, Left Inner Arm: Analysis was performed using ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||5.34|-17.29|0.299
72359290|NCT01787461|144230310|SUPERIORITY_OR_OTHER||LS Mean Difference|-9.07||||0.107|TWO_SIDED|95.0|-20.04|1.9|||ANOVA|||Change at Week 24, Left Inner Arm: Analysis was performed using ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||1.90|-20.04|0.107
72359291|NCT01787461|144230310|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.82||||0.776|TWO_SIDED|95.0|-14.39|10.76|||ANOVA|||Change at Week 6, Left Outer Arm: Analysis was performed using ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||10.76|-14.39|0.776
72359292|NCT01787461|144230310|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.33||||0.603|TWO_SIDED|95.0|-15.96|9.29|||ANOVA|||Change at Week 12, Left Outer Arm: Analysis was performed using ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||9.29|-15.96|0.603
72359293|NCT01787461|144230310|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.82||||0.51|TWO_SIDED|95.0|-15.23|7.6|||ANOVA|||Change at Week 18, Left Outer Arm: Analysis was performed using ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||7.60|-15.23|0.510
72359294|NCT01787461|144230310|SUPERIORITY_OR_OTHER||LS Mean Difference|-6.75||||0.225|TWO_SIDED|95.0|-17.7|4.2|||ANOVA|||Change at Week 24, Left Outer Arm: Analysis was performed using ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||4.20|-17.70|0.225
72359295|NCT01787461|144230311|SUPERIORITY_OR_OTHER||LS Mean Difference|0.78||||0.214|TWO_SIDED|95.0|-0.46|2.02|||ANOVA|||Change at Week 6, Left Cheek: Analysis was performed using ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||2.02|-0.46|0.214
72359296|NCT01787461|144230311|SUPERIORITY_OR_OTHER||LS Mean Difference|1.1||||0.027|TWO_SIDED|95.0|0.12|2.09|||ANOVA|||Change at Week 12, Left Cheek: Analysis was performed using ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||2.09|0.12|0.027
72359297|NCT01787461|144230311|SUPERIORITY_OR_OTHER||LS Mean Difference|0.99||||0.049|TWO_SIDED|95.0|0.01|1.96|||ANOVA|||Change at Week 18, Left Cheek: Analysis was performed using ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||1.96|0.01|0.049
72359298|NCT01787461|144230311|SUPERIORITY_OR_OTHER||LS Mean Difference|1.17||||0.019|TWO_SIDED|95.0|0.2|2.14|||ANOVA|||Change at Week 24, Left Cheek: Analysis was performed using ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||2.14|0.20|0.019
72359299|NCT01787461|144230311|SUPERIORITY_OR_OTHER||LS Mean Difference|0.22||||0.449|TWO_SIDED|95.0|-0.36|0.8|||ANOVA|||Change at Week 6, Left Inner Arm: Analysis was performed using ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||0.80|-0.36|0.449
72359300|NCT01787461|144230311|SUPERIORITY_OR_OTHER||LS Mean Difference|0.37||||0.105|TWO_SIDED|95.0|-0.07|0.8|||ANOVA|||Change at Week 12, Left Inner Arm: Analysis was performed using ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||0.80|-0.07|0.105
72359301|NCT01787461|144230311|SUPERIORITY_OR_OTHER||LS Mean Difference|0.27||||0.205|TWO_SIDED|95.0|-0.14|0.68|||ANOVA|||Change at Week 18, Left Inner Arm: Analysis was performed using ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||0.68|-0.14|0.205
72359302|NCT01787461|144230311|SUPERIORITY_OR_OTHER||LS Mean Difference|0.35||||0.1|TWO_SIDED|95.0|-0.06|0.77|||ANOVA|||Change at Week 24, Left Inner Arm: Analysis was performed using ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||0.77|-0.06|0.100
72359303|NCT01787461|144230311|SUPERIORITY_OR_OTHER||LS Mean Difference|0.25||||0.244|TWO_SIDED|95.0|-0.17|0.66|||ANOVA|||Change at Week 6, Left Outer Arm: Analysis was performed using ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||0.66|-0.17|0.244
72359304|NCT01787461|144230311|SUPERIORITY_OR_OTHER||LS Mean Difference|0.12||||0.594|TWO_SIDED|95.0|-0.32|0.56|||ANOVA|||Change at Week 12, Left Outer Arm: Analysis was performed using ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||0.56|-0.32|0.594
72359305|NCT01787461|144230311|SUPERIORITY_OR_OTHER||LS Mean Difference|0.22||||0.317|TWO_SIDED|95.0|-0.2|0.63|||ANOVA|||Change at Week 18, Left Outer Arm: Analysis was performed using ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||0.63|-0.20|0.317
72359306|NCT01787461|144230311|SUPERIORITY_OR_OTHER||LS Mean Difference|0.24||||0.264|TWO_SIDED|95.0|-0.17|0.64|||ANOVA|||Change at Week 24, Left Outer Arm: Analysis was performed using ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||0.64|-0.17|0.264
72359307|NCT01787461|144230312|SUPERIORITY_OR_OTHER||LS Mean Difference|-25.16||||0.266|TWO_SIDED|95.0|-69.63|19.31|||ANOVA|||Change at Week 6, Left Cheek: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||19.31|-69.63|0.266
72359308|NCT01787461|144230312|SUPERIORITY_OR_OTHER||LS Mean Difference|-28.79||||0.21|TWO_SIDED|95.0|-73.99|16.41|||ANOVA|||Change at Week 12, Left Cheek: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||16.41|-73.99|0.210
72359309|NCT01787461|144230312|SUPERIORITY_OR_OTHER||LS Mean Difference|-7.78||||0.753|TWO_SIDED|95.0|-56.55|40.99|||ANOVA|||Change at Week 18, Left Cheek: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||40.99|-56.55|0.753
72429364|NCT04102540|144369720|OTHER|In this analysis, our null hypothesis was that the median CD4 count at baseline/exposure 1 was exactly equivalent to the median CD4 count following exposure 2 to the intervention.|Median Difference (Net)|57.39||||0.283|TWO_SIDED|95.0|-48.9|163.7||The p-value was not adjusted for multiple comparisons and the a priori threshold for significance was alpha = 0.05.|Quantile Regression|Random intercepts for subjects were included in the model.|This is the difference in median CD4 count between baseline/exposure 1 and exposure 2.|Statistical analysis of CD4 count between baseline/exposure 1 and exposure 2 to the intervention.||163.7|-48.9|0.283
72359310|NCT01787461|144230312|SUPERIORITY_OR_OTHER||LS Mean Difference|-14.9||||0.632|TWO_SIDED|95.0|-76.32|46.51|||ANOVA|||Change at Week 24, Left Cheek: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||46.51|-76.32|0.632
72359311|NCT01787461|144230312|SUPERIORITY_OR_OTHER||LS Mean Difference|4.54||||0.715|TWO_SIDED|95.0|-19.94|29.01|||ANOVA|||Change at Week 6, Left Inner Arm: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||29.01|-19.94|0.715
72359312|NCT01787461|144230312|SUPERIORITY_OR_OTHER||LS Mean Difference|6.35||||0.648|TWO_SIDED|95.0|-21.04|33.75|||ANOVA|||Change at Week 12, Left Inner Arm: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||33.75|-21.04|0.648
72359313|NCT01787461|144230312|SUPERIORITY_OR_OTHER||LS Mean Difference|-16.49||||0.315|TWO_SIDED|95.0|-48.81|15.83|||ANOVA|||Change at Week 18, Left Inner Arm: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||15.83|-48.81|0.315
72359314|NCT01787461|144230312|SUPERIORITY_OR_OTHER||LS Mean Difference|14.42||||0.402|TWO_SIDED|95.0|-19.5|48.34|||ANOVA|||Change at Week 24, Left Inner Arm: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||48.34|-19.50|0.402
72359315|NCT01787461|144230312|SUPERIORITY_OR_OTHER||LS Mean Difference|12.43||||0.381|TWO_SIDED|95.0|-15.49|40.35|||ANOVA|||Change at Week 6, Left Outer Arm: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||40.35|-15.49|0.381
72359316|NCT01787461|144230312|SUPERIORITY_OR_OTHER||LS Mean Difference|1.49||||0.916|TWO_SIDED|95.0|-26.44|29.43|||ANOVA|||Change at Week 12, Left Outer Arm: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||29.43|-26.44|0.916
72359317|NCT01787461|144230312|SUPERIORITY_OR_OTHER||LS Mean Difference|-9.88||||0.566|TWO_SIDED|95.0|-43.81|24.05|||ANOVA|||Change at Week 18, Left Outer Arm: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||24.05|-43.81|0.566
72359318|NCT01787461|144230312|SUPERIORITY_OR_OTHER||LS Mean Difference|8.58||||0.667|TWO_SIDED|95.0|-30.78|47.94|||ANOVA|||Change at Week 24, Left Outer Arm: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||47.94|-30.78|0.667
72359319|NCT01787461|144230313|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.6||||0.458|TWO_SIDED|95.0|-2.21|1.0|||ANOVA|||Change at Week 6, Left Cheek: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||1.00|-2.21|0.458
72359320|NCT01787461|144230313|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.53||||0.497|TWO_SIDED|95.0|-2.07|1.01|||ANOVA|||Change at Week 12, Left Cheek: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||1.01|-2.07|0.497
72359321|NCT01787461|144230313|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.36||||0.113|TWO_SIDED|95.0|-3.05|0.33|||ANOVA|||Change at Week 18, Left Cheek: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||0.33|-3.05|0.113
72359322|NCT01787461|144230313|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.34||||0.708|TWO_SIDED|95.0|-2.11|1.44|||ANOVA|||Change at Week 24, Left Cheek: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||1.44|-2.11|0.708
72359323|NCT01787461|144230313|SUPERIORITY_OR_OTHER||LS Mean Difference|1.24||||0.495|TWO_SIDED|95.0|-2.34|4.82|||ANOVA|||Change at Week 6, Left Inner Arm: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||4.82|-2.34|0.495
72359324|NCT01787461|144230313|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.85||||0.243|TWO_SIDED|95.0|-4.96|1.27|||ANOVA|||Change at Week 12, Left Inner Arm: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||1.27|-4.96|0.243
72359325|NCT01787461|144230313|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.36||||0.453|TWO_SIDED|95.0|-4.96|2.23|||ANOVA|||Change at Week 18, Left Inner Arm: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||2.23|-4.96|0.453
72359326|NCT01787461|144230313|SUPERIORITY_OR_OTHER||LS Mean Difference|0.55||||0.745|TWO_SIDED|95.0|-2.79|3.89|||ANOVA|||Change at Week 24, Left Inner Arm: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||3.89|-2.79|0.745
72359327|NCT01787461|144230313|SUPERIORITY_OR_OTHER||LS Mean Difference|0.02||||0.987|TWO_SIDED|95.0|-2.44|2.48|||ANOVA|||Change at Week 6, Left Outer Arm: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||2.48|-2.44|0.987
72359328|NCT01787461|144230313|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.42||||0.218|TWO_SIDED|95.0|-3.69|0.85|||ANOVA|||Change at Week 12, Left Outer Arm: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||0.85|-3.69|0.218
72359329|NCT01787461|144230313|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.67||||0.63|TWO_SIDED|95.0|-3.41|2.08|||ANOVA|||Change at Week 18, Left Outer Arm: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||2.08|-3.41|0.630
72359330|NCT01787461|144230313|SUPERIORITY_OR_OTHER||LS Mean Difference|0.81||||0.576|TWO_SIDED|95.0|-2.06|3.68|||ANOVA|||Change at Week 24, Left Outer Arm: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||3.68|-2.06|0.576
72359331|NCT03883581|144230314|SUPERIORITY|||||||0.08|||||||Wilcoxon (Mann-Whitney)|||||||0.08
72359332|NCT03883581|144230315|SUPERIORITY|||||||0.647|||||||Paired t test|||||||0.647
72359333|NCT03883581|144230316|SUPERIORITY|||||||0.103|||||||Paired t test|||||||0.103
72359334|NCT03883581|144230317|SUPERIORITY|||||||0.0004|||||||Wilcoxon (Mann-Whitney)|||||||0.0004
72359335|NCT03883581|144230318|SUPERIORITY|||||||0.103|||||||Paired t test|||||||0.103
72359336|NCT04612725|144230319|SUPERIORITY||LS mean difference|-1.01||||0.3824|TWO_SIDED|95.0|-3.28|1.26||Change from baseline in ISS7 at Week 12= Treatment + baseline ISS7 + region (Europe, North America, Asia) + visit + treatment by visit.|Mixed-effect model for repeated measures|||||1.26|-3.28|0.3824
72359337|NCT04612725|144230319|SUPERIORITY||LS mean difference|-1.79||||0.1244|TWO_SIDED|95.0|-4.09|0.5||Change from baseline in ISS7 at Week 12= Treatment + baseline ISS7 + region (Europe, North America, Asia) + visit + treatment by visit.|Mixed-effect model for repeated measures|||||0.50|-4.09|0.1244
72359338|NCT04612725|144230320|SUPERIORITY||LS mean difference|-2.07||||0.4016|TWO_SIDED|95.0|-6.95|2.8||Change from baseline in UAS7 at Week 12= Treatment + baseline UAS7 + region (Europe, North America, Asia) + visit + treatment by visit.|Mixed-effect model for repeated measures|||||2.80|-6.95|0.4016
72359339|NCT04612725|144230320|SUPERIORITY||LS mean difference|-4.36||||0.0819|TWO_SIDED|95.0|-9.28|0.56||Change from baseline in UAS7 at Week 12= Treatment + baseline UAS7 + region (Europe, North America, Asia) + visit + treatment by visit.|Mixed-effect model for repeated measures|||||0.56|-9.28|0.0819
72359340|NCT04612725|144230320|SUPERIORITY||LS mean difference|-2.56||||0.3314|TWO_SIDED|95.0|-7.74|2.63||Change from baseline in UAS7 at Week 24= Treatment + baseline UAS7 + region (Europe, North America, Asia) + visit + treatment by visit.|Mixed-effect model for repeated measures|||||2.63|-7.74|0.3314
72359341|NCT04612725|144230320|SUPERIORITY||LS mean difference|-3.74||||0.1582|TWO_SIDED|95.0|-8.95|1.47||Change from baseline in UAS7 at Week 24= Treatment + baseline UAS7 + region (Europe, North America, Asia) + visit + treatment by visit.|Mixed-effect model for repeated measures|||||1.47|-8.95|0.1582
72359342|NCT04612725|144230321|SUPERIORITY||LS mean difference|-1.62||||0.1995|TWO_SIDED|95.0|-4.1|0.86||Change from baseline in ISS7 at Week 24= Treatment + baseline ISS7 + region (Europe, North America, Asia) + visit + treatment by visit.|Mixed-effect model for repeated measures|||||0.86|-4.10|0.1995
72359343|NCT04612725|144230321|SUPERIORITY||LS mean difference|-1.76||||0.1654|TWO_SIDED|95.0|-4.25|0.73||Change from baseline in ISS7 at Week 24= Treatment + baseline ISS7 + region (Europe, North America, Asia) + visit + treatment by visit.|Mixed-effect model for repeated measures|||||0.73|-4.25|0.1654
72359344|NCT04612725|144230322|SUPERIORITY||percentage difference|11.72||||0.1373|TWO_SIDED|95.0|-2.37|25.82||Week 12: Estimates included treatment group, region (Europe, North America, Asia) and baseline UAS7.|Regression, Logistic|||||25.82|-2.37|0.1373
72359345|NCT04612725|144230322|SUPERIORITY||percentage difference|10.73||||0.1697|TWO_SIDED|95.0|-3.42|24.88||Week 12: Estimates included treatment group, region (Europe, North America, Asia) and baseline UAS7.|Regression, Logistic|||||24.88|-3.42|0.1697
72359346|NCT04612725|144230322|SUPERIORITY||percentage difference|1.03||||0.9105|TWO_SIDED|95.0|-16.9|18.96||Week 24: Estimates included treatment group, region (Europe, North America, Asia) and baseline UAS7.|Regression, Logistic|||||18.96|-16.90|0.9105
72359347|NCT04612725|144230322|SUPERIORITY||percentage difference|9.27||||0.3389|TWO_SIDED|95.0|-9.37|27.9||Week 24: Estimates included treatment group, region (Europe, North America, Asia) and baseline UAS7.|Regression, Logistic|||||27.90|-9.37|0.3389
72359348|NCT04612725|144230323|SUPERIORITY||LS mean difference|-1.16||||0.4203|TWO_SIDED|95.0|-4.0|1.68||Change from baseline in HSS7 at Week 12= Treatment + baseline HSS7 + region (Europe, North America, Asia) + visit + treatment by visit.|Mixed-effect model for repeated measures|||||1.68|-4.00|0.4203
72359349|NCT04612725|144230323|SUPERIORITY||LS mean difference|-2.6||||0.0754|TWO_SIDED|95.0|-5.46|0.27||Change from baseline in HSS7 at Week 12= Treatment + baseline HSS7 + region (Europe, North America, Asia) + visit + treatment by visit.|Mixed-effect model for repeated measures|||||0.27|-5.46|0.0754
72359350|NCT04612725|144230323|SUPERIORITY||LS mean difference|-1.06||||0.4772|TWO_SIDED|95.0|-4.01|1.89||Change from baseline in HSS7 at Week 24= Treatment + baseline HSS7 + region (Europe, North America, Asia) + visit + treatment by visit.|Mixed-effect model for repeated measures|||||1.89|-4.01|0.4772
72359351|NCT04612725|144230323|SUPERIORITY||LS mean difference|-2.0||||0.1851|TWO_SIDED|95.0|-4.96|0.97||Change from baseline in HSS7 at Week 24= Treatment + baseline HSS7 + region (Europe, North America, Asia) + visit + treatment by visit.|Mixed-effect model for repeated measures|||||0.97|-4.96|0.1851
72359352|NCT04612725|144230325|SUPERIORITY|||||||0.9678||||||Week 12: Estimates included treatment group, region (Europe, North America, Asia) and baseline UAS7.|Regression, Logistic|||||||0.9678
72359353|NCT04612725|144230325|SUPERIORITY|||||||0.3689||||||Week 12: Estimates included treatment group, region (Europe, North America, Asia) and baseline UAS7.|Regression, Logistic|||||||0.3689
72359354|NCT04612725|144230325|SUPERIORITY||percentage difference|-3.43||||0.6624|TWO_SIDED|95.0|-18.96|12.11||Week 24: Estimates included treatment group, region (Europe, North America, Asia) and baseline UAS7.|Regression, Logistic|||||12.11|-18.96|0.6624
72359355|NCT04612725|144230325|SUPERIORITY||percentage difference|0.28||||0.9726|TWO_SIDED|95.0|-15.84|16.4||Week 24: Estimates included treatment group, region (Europe, North America, Asia) and baseline UAS7.|Regression, Logistic|||||16.40|-15.84|0.9726
72359356|NCT04612725|144230327|SUPERIORITY||LS mean difference|-0.29||||0.7256|TWO_SIDED|95.0|-1.9|1.32||Change from baseline in UCT at Week 12= Treatment + baseline UCT + region (Europe, North America, Asia) + visit + treatment by visit.|Mixed-effect model for repeated measures|||||1.32|-1.90|0.7256
72359357|NCT04612725|144230327|SUPERIORITY||LS mean difference|1.09||||0.189|TWO_SIDED|95.0|-0.54|2.72||Change from baseline in UCT at Week 12= Treatment + baseline UCT + region (Europe, North America, Asia) + visit + treatment by visit.|Mixed-effect model for repeated measures|||||2.72|-0.54|0.1890
72359358|NCT04612725|144230327|SUPERIORITY||LS mean difference|-0.63||||0.5048|TWO_SIDED|95.0|-2.51|1.24||Change from baseline in UCT at Week 24= Treatment + baseline UCT + region (Europe, North America, Asia) + visit + treatment by visit.|Mixed-effect model for repeated measures|||||1.24|-2.51|0.5048
72359359|NCT04612725|144230327|SUPERIORITY||LS mean difference|0.99||||0.2991|TWO_SIDED|95.0|-0.89|2.88||Change from baseline in UCT at Week 24= Treatment + baseline UCT + region (Europe, North America, Asia) + visit + treatment by visit.|Mixed-effect model for repeated measures|||||2.88|-0.89|0.2991
72359360|NCT04612725|144230328|SUPERIORITY||LS mean difference|1.63||||0.5704|TWO_SIDED|95.0|-4.05|7.32||Change from baseline in CU-Q2oL at Week 12= Treatment + baseline CU-Q2oL + region (Europe, North America, Asia) + visit + treatment by visit.|Mixed-effect model for repeated measures|||||7.32|-4.05|0.5704
72359361|NCT04612725|144230328|SUPERIORITY||LS mean difference|-2.24||||0.4416|TWO_SIDED|95.0|-7.98|3.5||Change from baseline in CU-Q2oL at Week 12= Treatment + baseline CU-Q2oL + region (Europe, North America, Asia) + visit + treatment by visit.|Mixed-effect model for repeated measures|||||3.50|-7.98|0.4416
72359362|NCT04612725|144230328|SUPERIORITY||LS mean difference|1.47||||0.6591|TWO_SIDED|95.0|-5.09|8.02||Change from baseline in CU-Q2oL at Week 24= Treatment + baseline CU-Q2oL + region (Europe, North America, Asia) + visit + treatment by visit.|Mixed-effect model for repeated measures|||||8.02|-5.09|0.6591
72359363|NCT04612725|144230328|SUPERIORITY||LS mean difference|-3.04||||0.3624|TWO_SIDED|95.0|-9.62|3.54||Change from baseline in CU-Q2oL at Week 24= Treatment + baseline CU-Q2oL + region (Europe, North America, Asia) + visit + treatment by visit.|Mixed-effect model for repeated measures|||||3.54|-9.62|0.3624
72359364|NCT04612725|144230329|SUPERIORITY||LS mean difference|0.48||||0.7037|TWO_SIDED|95.0|-2.02|2.98||Change from baseline in DLQI at Week 12= Treatment + baseline DLQI + region (Europe, North America, Asia) + visit + treatment by visit.|Mixed-effect model for repeated measures|||||2.98|-2.02|0.7037
72359365|NCT04612725|144230329|SUPERIORITY||LS mean difference|-1.25||||0.332|TWO_SIDED|95.0|-3.78|1.29||Change from baseline in DLQI at Week 12= Treatment + baseline DLQI + region (Europe, North America, Asia) + visit + treatment by visit.|Mixed-effect model for repeated measures|||||1.29|-3.78|0.3320
72359366|NCT04612725|144230329|SUPERIORITY||LS mean difference|1.24||||0.359|TWO_SIDED|95.0|-1.42|3.9||Change from baseline in DLQI at Week 24= Treatment + baseline DLQI + region (Europe, North America, Asia) + visit + treatment by visit.|Mixed-effect model for repeated measures|||||3.90|-1.42|0.3590
72359367|NCT04612725|144230329|SUPERIORITY||LS mean difference|-0.88||||0.5175|TWO_SIDED|95.0|-3.56|1.8||Change from baseline in DLQI at Week 24= Treatment + baseline DLQI + region (Europe, North America, Asia) + visit + treatment by visit.|Mixed-effect model for repeated measures|||||1.80|-3.56|0.5175
72359368|NCT02354235|144230332|SUPERIORITY||Least Squares Mean Difference|-0.88|STANDARD_ERROR_OF_MEAN|0.14|<|0.001|TWO_SIDED|95.0|-1.15|-0.6|||ANCOVA|||||-0.60|-1.15|<0.001
72359369|NCT02354235|144230333|SUPERIORITY||Least Squares Mean Difference|-38.8|STANDARD_ERROR_OF_MEAN|4.9|<|0.001|TWO_SIDED|95.0|-48.5|-29.2|||ANCOVA|||||-29.2|-48.5|<0.001
72359370|NCT02354235|144230334|SUPERIORITY||Least Squares Mean Difference|-2.33|STANDARD_ERROR_OF_MEAN|0.44|<|0.001|TWO_SIDED|95.0|-3.2|-1.45|||ANCOVA|||||-1.45|-3.20|<0.001
72359371|NCT02354235|144230335|SUPERIORITY||Least Squares Mean Difference|-100.3|STANDARD_ERROR_OF_MEAN|11.1|<|0.001|TWO_SIDED|95.0|-122.2|-78.4|||ANCOVA|||||-78.4|-122.2|<0.001
72359372|NCT02354235|144230336|SUPERIORITY||Least Squares Mean Difference|-50.9|STANDARD_ERROR_OF_MEAN|7.1|<|0.001|TWO_SIDED|95.0|-64.9|-36.9|||ANCOVA|||||-36.9|-64.9|<0.001
72359373|NCT01908426|144230356|SUPERIORITY||Hazard Ratio (HR)|0.76||||0.0049|TWO_SIDED|95.0|0.63|0.92|||Log Rank|The Log-Rank Test was stratified by etiology of disease, geo. region, presence of extrahepatic spread of disease and/or macrovascular invasion.||||0.92|0.63|0.0049
72359374|NCT01908426|144230357|SUPERIORITY||Hazard Ratio (HR)|0.44|||<|0.0001|TWO_SIDED|95.0|0.36|0.52|||Log Rank|The Log Rank Test was stratified by etiology of disease, geographic region, presence of extrahepatic spread of disease and/or macrovascular invasion.||||0.52|0.36|< 0.0001
72359375|NCT01908426|144230358|SUPERIORITY|||||||0.0086|||||||Cochran-Mantel-Haenszel|||||||0.0086
72359376|NCT01782898|144230366|SUPERIORITY_OR_OTHER|||||||0.82|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.82
72359377|NCT01782898|144230367|SUPERIORITY_OR_OTHER|||||||0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.05
72359378|NCT01782898|144230368|SUPERIORITY_OR_OTHER|||||||0.14|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.14
72359379|NCT00141453|144230400|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.97||||0.79||95.0|0.75|1.24|||Regression, Cox|The covariates were urinary albumin:creatinine ratio and serum creatinine at baseline \& regions (Japan/Hong Kong) for the renal composite event rate.||We planned to collect 400 patients to detect 35% risk reduction for renal outcome in olmesartan group with 80% power at 2-sided .05 alpha level. The Cox regression model was applied to estimate the hazard ratios (HR)between treatment groups with 95% confidence intervals for the renal and cardiovascular composite event rate.||1.24|0.75|0.79
72359380|NCT00141453|144230401|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.64||||0.039||95.0|0.43|0.98|||Regression, Cox|Covariates baseline urinary albumin:creatinine ratio, age and history of cardiovascular disease for cardiovascular composite event rate.||||0.98|0.43|0.039
72359381|NCT00718510|144230479|OTHER||||||<|0.05||||||General Psychopathology Subscale Score|ANOVA|F(1,11)=5.03||Null hypothesis is that there was no difference in change of PANSS between L-arginine and Placebo. A two-factor ANOVA was used across all subjects with the within-subject factor being the treatment phase (L-arginine first/Placebo second or Placebo first/L-arginine second) and the between-subject factor being the day of treatment (time). A sample size of 14 patients was needed to give 90% power to detect a 4 point difference on the PANSS. This included a drop-out rate of about 10%.||||<0.05
72359382|NCT00718510|144230480|OTHER|||||||0.46|||||||ANOVA|||Null hypothesis is that there was no difference in change of CGI ratings between L-arginine and Placebo. A two-factor ANOVA was used across all subjects with the within-subject factor being the treatment phase (L-arginine first/Placebo second or Placebo first/L-arginine second) and the between-subject factor being the day of treatment (time).||||0.46
72359383|NCT00718510|144230481|OTHER|||||||0.55|||||||ANOVA|||Null hypothesis is that there was no difference in change of CDSS ratings between L-arginine and Placebo. A two-factor ANOVA was used across all subjects with the within-subject factor being the treatment phase (L-arginine first/Placebo second or Placebo first/L-arginine second) and the between-subject factor being the day of treatment (time).||||0.55
72359384|NCT00467740|144230485|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.08|STANDARD_ERROR_OF_MEAN|0.045||0.0754||95.0|-0.008|0.167|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 2 mcg qd minus Placebo|||0.167|-0.008|0.0754
72359385|NCT00467740|144230485|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.086|STANDARD_ERROR_OF_MEAN|0.045||0.0571||95.0|-0.003|0.174|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 5 mcg qd minus Placebo|||0.174|-0.003|0.0571
72359386|NCT00467740|144230485|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.076|STANDARD_ERROR_OF_MEAN|0.045||0.0906||95.0|-0.012|0.164|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 10 mcg qd minus Placebo|||0.164|-0.012|0.0906
72359387|NCT00467740|144230485|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.147|STANDARD_ERROR_OF_MEAN|0.044||0.0011||95.0|0.059|0.234|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 20 mcg qd minus Placebo|||0.234|0.059|0.0011
72359388|NCT00467740|144230486|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.238|STANDARD_ERROR_OF_MEAN|7.843||0.0393||95.0|0.801|31.675|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 2 mcg qd minus Placebo|||31.675|0.801|0.0393
72359389|NCT00467740|144230486|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|27.878|STANDARD_ERROR_OF_MEAN|7.875||0.0005||95.0|12.379|43.378|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 5 mcg qd minus Placebo|||43.378|12.379|0.0005
72359390|NCT00467740|144230486|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|36.072|STANDARD_ERROR_OF_MEAN|7.906|<|0.0001||95.0|20.512|51.633|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 10 mcg qd minus Placebo|||51.633|20.512|<0.0001
72359391|NCT00467740|144230486|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|42.943|STANDARD_ERROR_OF_MEAN|7.848|<|0.0001||95.0|27.498|58.389|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 20 mcg qd minus Placebo|||58.389|27.498|<0.0001
72359392|NCT00467740|144230487|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.067|STANDARD_ERROR_OF_MEAN|0.044||0.1264||95.0|-0.019|0.154|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 2 mcg qd minus Placebo|||0.154|-0.019|0.1264
72359393|NCT00467740|144230487|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.101|STANDARD_ERROR_OF_MEAN|0.044||0.0232||95.0|0.014|0.188|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 5 mcg qd minus Placebo|||0.188|0.014|0.0232
72359394|NCT00467740|144230487|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.114|STANDARD_ERROR_OF_MEAN|0.044||0.0106||95.0|0.027|0.2|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 10 mcg qd minus Placebo|||0.200|0.027|0.0106
72429365|NCT04102540|144369720|OTHER|In this analysis, our null hypothesis was that the median CD4 count at baseline/exposure 1 was exactly equivalent to the median CD4 count following the exposure 3 to the intervention.|Median Difference (Net)|60.83||||0.1823|TWO_SIDED|95.0|-29.5|151.2||The p-value was not adjusted for multiple comparisons and the a priori threshold for significance was alpha = 0.05.|Quantile regression|Random intercepts for subjects were included in the model.|This is the difference in median CD4 count between baseline/exposure 1 and exposure 3.|Statistical analysis of CD4 count between baseline/exposure 1 and exposure 3 to the intervention.||151.2|-29.5|0.1823
72359395|NCT00467740|144230487|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.173|STANDARD_ERROR_OF_MEAN|0.044||0.0001||95.0|0.087|0.26|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 20 mcg qd minus Placebo|||0.260|0.087|0.0001
72359396|NCT00467740|144230488|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.103|STANDARD_ERROR_OF_MEAN|0.048||0.0329||95.0|0.008|0.198|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 2 mcg qd minus Placebo|||0.198|0.008|0.0329
72359397|NCT00467740|144230488|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.089|STANDARD_ERROR_OF_MEAN|0.048||0.0666||95.0|-0.006|0.184|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 5 mcg qd minus Placebo|||0.184|-0.006|0.0666
72359398|NCT00467740|144230488|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.043|STANDARD_ERROR_OF_MEAN|0.048||0.3738||95.0|-0.052|0.137|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 10 mcg qd minus Placebo|||0.137|-0.052|0.3738
72359399|NCT00467740|144230488|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.14|STANDARD_ERROR_OF_MEAN|0.048||0.0037||95.0|0.046|0.234|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 20 mcg qd minus Placebo|||0.234|0.046|0.0037
72359400|NCT00467740|144230489|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.051|STANDARD_ERROR_OF_MEAN|0.046||0.2646||95.0|-0.039|0.142|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 2 mcg qd minus Placebo|||0.142|-0.039|0.2646
72359401|NCT00467740|144230489|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.043|STANDARD_ERROR_OF_MEAN|0.046||0.3527||95.0|-0.048|0.135|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 5 mcg qd minus Placebo|||0.135|-0.048|0.3527
72359402|NCT00467740|144230489|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.069|STANDARD_ERROR_OF_MEAN|0.046||0.1369||95.0|-0.022|0.16|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 10 mcg qd minus Placebo|||0.160|-0.022|0.1369
72359403|NCT00467740|144230489|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.13|STANDARD_ERROR_OF_MEAN|0.046||0.0051||95.0|0.039|0.221|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 20 mcg qd minus Placebo|||0.221|0.039|0.0051
72359404|NCT00467740|144230490|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.127|STANDARD_ERROR_OF_MEAN|0.053||0.017||95.0|0.023|0.232|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 2 mcg qd minus Placebo|||0.232|0.023|0.0170
72359405|NCT00467740|144230490|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.099|STANDARD_ERROR_OF_MEAN|0.053||0.0646||95.0|-0.006|0.204|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 5 mcg qd minus Placebo|||0.204|-0.006|0.0646
72359406|NCT00467740|144230490|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.028|STANDARD_ERROR_OF_MEAN|0.053||0.602||95.0|-0.077|0.132|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 10 mcg qd minus Placebo|||0.132|-0.077|0.6020
72359407|NCT00467740|144230490|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.13|STANDARD_ERROR_OF_MEAN|0.053||0.0147||95.0|0.026|0.233|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 20 mcg qd minus Placebo|||0.233|0.026|0.0147
72359408|NCT00467740|144230491|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.037|STANDARD_ERROR_OF_MEAN|0.053||0.4902||95.0|-0.068|0.142|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 2 mcg qd minus Placebo|||0.142|-0.068|0.4902
72359409|NCT00467740|144230491|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.058|STANDARD_ERROR_OF_MEAN|0.054||0.2832||95.0|-0.048|0.164|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 5 mcg qd minus Placebo|||0.164|-0.048|0.2832
72359410|NCT00467740|144230491|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.024|STANDARD_ERROR_OF_MEAN|0.054||0.6516||95.0|-0.081|0.13|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 10 mcg qd minus Placebo|||0.130|-0.081|0.6516
72359411|NCT00467740|144230491|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.147|STANDARD_ERROR_OF_MEAN|0.053||0.006||95.0|0.042|0.252|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 20 mcg qd minus Placebo|||0.252|0.042|0.0060
72359412|NCT00467740|144230492|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.178|STANDARD_ERROR_OF_MEAN|0.05||0.0005||95.0|0.079|0.277|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 2 mcg qd minus Placebo|||0.277|0.079|0.0005
72359413|NCT00467740|144230492|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.137|STANDARD_ERROR_OF_MEAN|0.051||0.007||95.0|0.038|0.237|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 5 mcg qd minus Placebo|||0.237|0.038|0.0070
72429366|NCT04102540|144369721|OTHER|In this analysis, our null hypothesis was that the median viral load at baseline/exposure 1 was exactly equivalent to the median viral load following exposure 2 to the intervention.|Median Difference (Net)|-42.0||||0.7795|TWO_SIDED|95.0|-339.8|255.8||The p-value was not adjusted for multiple comparisons and the a priori threshold for significance was alpha = 0.05.|Quantile Regression||This is the difference in median viral load between baseline/exposure 1 and exposure 2.|Statistical analysis of viral load between baseline/exposure 1 and exposure 2 to the intervention.||255.8|-339.8|0.7795
72359414|NCT00467740|144230492|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.099|STANDARD_ERROR_OF_MEAN|0.05||0.0512||95.0|-0.001|0.198|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 10 mcg qd minus Placebo|||0.198|-0.001|0.0512
72359415|NCT00467740|144230492|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.232|STANDARD_ERROR_OF_MEAN|0.05|<|0.0001||95.0|0.133|0.331|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 20 mcg qd minus Placebo|||0.331|0.133|<0.0001
72359416|NCT00467740|144230493|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.082|STANDARD_ERROR_OF_MEAN|0.061||0.1811||95.0|-0.039|0.203|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 2 mcg qd minus Placebo|||0.203|-0.039|0.1811
72359417|NCT00467740|144230493|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.077|STANDARD_ERROR_OF_MEAN|0.062||0.2118||95.0|-0.044|0.199|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 5 mcg qd minus Placebo|||0.199|-0.044|0.2118
72359418|NCT00467740|144230493|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.037|STANDARD_ERROR_OF_MEAN|0.062||0.5504||95.0|-0.085|0.158|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 10 mcg qd minus Placebo|||0.158|-0.085|0.5504
72359419|NCT00467740|144230493|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.191|STANDARD_ERROR_OF_MEAN|0.062||0.0022||95.0|0.069|0.312|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 20 mcg qd minus Placebo|||0.312|0.069|0.0022
72359420|NCT00467740|144230494|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.178|STANDARD_ERROR_OF_MEAN|0.039|<|0.0001||95.0|0.102|0.255|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 2 mcg qd minus Placebo|||0.255|0.102|<0.0001
72359421|NCT00467740|144230494|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.183|STANDARD_ERROR_OF_MEAN|0.039|<|0.0001||95.0|0.106|0.26|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 5 mcg qd minus Placebo|||0.260|0.106|<0.0001
72359422|NCT00467740|144230494|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.173|STANDARD_ERROR_OF_MEAN|0.039|<|0.0001||95.0|0.096|0.25|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 10 mcg qd minus Placebo|||0.250|0.096|<0.0001
72359423|NCT00467740|144230494|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.291|STANDARD_ERROR_OF_MEAN|0.039|<|0.0001||95.0|0.214|0.367|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 20 mcg qd minus Placebo|||0.367|0.214|<0.0001
72359424|NCT00467740|144230495|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.19|STANDARD_ERROR_OF_MEAN|0.045|<|0.0001||95.0|0.101|0.279|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 2 mcg qd minus Placebo|||0.279|0.101|<0.0001
72359425|NCT00467740|144230495|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.196|STANDARD_ERROR_OF_MEAN|0.046|<|0.0001||95.0|0.107|0.286|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 5 mcg qd minus Placebo|||0.286|0.107|<0.0001
72359426|NCT00467740|144230495|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.157|STANDARD_ERROR_OF_MEAN|0.045||0.0007||95.0|0.067|0.246|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 10 mcg qd minus Placebo|||0.246|0.067|0.0007
72359427|NCT00467740|144230495|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.263|STANDARD_ERROR_OF_MEAN|0.045|<|0.0001||95.0|0.174|0.352|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 20 mcg qd minus Placebo|||0.352|0.174|<0.0001
72359428|NCT00467740|144230496|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.214|STANDARD_ERROR_OF_MEAN|0.05|<|0.0001||95.0|0.115|0.313|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 2 mcg qd minus Placebo|||0.313|0.115|<0.0001
72359429|NCT00467740|144230496|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.156|STANDARD_ERROR_OF_MEAN|0.05||0.0021||95.0|0.057|0.255|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 5 mcg qd minus Placebo|||0.255|0.057|0.0021
72359430|NCT00467740|144230496|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.088|STANDARD_ERROR_OF_MEAN|0.05||0.0795||95.0|-0.01|0.187|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 10 mcg qd minus Placebo|||0.187|-0.010|0.0795
72359431|NCT00467740|144230496|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.227|STANDARD_ERROR_OF_MEAN|0.05|<|0.0001||95.0|0.129|0.326|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 20 mcg qd minus Placebo|||0.326|0.129|<0.0001
72359432|NCT00467740|144230497|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.179|STANDARD_ERROR_OF_MEAN|0.049||0.0003||95.0|0.082|0.276|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 2 mcg qd minus Placebo|||0.276|0.082|0.0003
72359433|NCT00467740|144230497|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.132|STANDARD_ERROR_OF_MEAN|0.049||0.0077||95.0|0.035|0.229|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 5 mcg qd minus Placebo|||0.229|0.035|0.0077
72359434|NCT00467740|144230497|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.049||0.0427||95.0|0.003|0.197|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 10 mcg qd minus Placebo|||0.197|0.003|0.0427
72359435|NCT00467740|144230497|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.24|STANDARD_ERROR_OF_MEAN|0.049|<|0.0001||95.0|0.143|0.336|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 20 mcg qd minus Placebo|||0.336|0.143|<0.0001
72359436|NCT00467740|144230498|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.169|STANDARD_ERROR_OF_MEAN|0.048||0.0005||95.0|0.074|0.263|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 2 mcg qd minus Placebo|||0.263|0.074|0.0005
72359437|NCT00467740|144230498|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.174|STANDARD_ERROR_OF_MEAN|0.048||0.0003||95.0|0.08|0.269|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 5 mcg qd minus Placebo|||0.269|0.080|0.0003
72359438|NCT00467740|144230498|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.173|STANDARD_ERROR_OF_MEAN|0.048||0.0004||95.0|0.078|0.268|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 10 mcg qd minus Placebo|||0.268|0.078|0.0004
72359439|NCT00467740|144230498|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.296|STANDARD_ERROR_OF_MEAN|0.048|<|0.0001||95.0|0.202|0.39|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 20 mcg qd minus Placebo|||0.390|0.202|<0.0001
72359440|NCT00467740|144230499|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.173|STANDARD_ERROR_OF_MEAN|0.048||0.0004||95.0|0.078|0.268|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 2 mcg qd minus Placebo|||0.268|0.078|0.0004
72359441|NCT00467740|144230499|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.185|STANDARD_ERROR_OF_MEAN|0.048||0.0002||95.0|0.09|0.281|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 5 mcg qd minus Placebo|||0.281|0.090|0.0002
72359442|NCT00467740|144230499|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.138|STANDARD_ERROR_OF_MEAN|0.048||0.0047||95.0|0.043|0.233|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 10 mcg qd minus Placebo|||0.233|0.043|0.0047
72359443|NCT00467740|144230499|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.237|STANDARD_ERROR_OF_MEAN|0.048|<|0.0001||95.0|0.142|0.332|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 20 mcg qd minus Placebo|||0.332|0.142|<0.0001
72359444|NCT00467740|144230500|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.204|STANDARD_ERROR_OF_MEAN|0.055||0.0002||95.0|0.096|0.312|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 2 mcg qd minus Placebo|||0.312|0.096|0.0002
72359445|NCT00467740|144230500|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.153|STANDARD_ERROR_OF_MEAN|0.055||0.0057||95.0|0.045|0.261|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 5 mcg qd minus Placebo|||0.261|0.045|0.0057
72359446|NCT00467740|144230500|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.079|STANDARD_ERROR_OF_MEAN|0.055||0.1513||95.0|-0.029|0.186|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 10 mcg qd minus Placebo|||0.186|-0.029|0.1513
72359447|NCT00467740|144230500|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.221|STANDARD_ERROR_OF_MEAN|0.055|<|0.0001||95.0|0.114|0.328|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 20 mcg qd minus Placebo|||0.328|0.114|<0.0001
72359448|NCT00467740|144230501|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.166|STANDARD_ERROR_OF_MEAN|0.054||0.0022||95.0|0.06|0.271|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 2 mcg qd minus Placebo|||0.271|0.060|0.0022
72359449|NCT00467740|144230501|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.117|STANDARD_ERROR_OF_MEAN|0.054||0.0307||95.0|0.011|0.223|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 5 mcg qd minus Placebo|||0.223|0.011|0.0307
72359450|NCT00467740|144230501|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.081|STANDARD_ERROR_OF_MEAN|0.054||0.132||95.0|-0.025|0.187|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 10 mcg qd minus Placebo|||0.187|-0.025|0.1320
72359451|NCT00467740|144230501|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.232|STANDARD_ERROR_OF_MEAN|0.054|<|0.0001||95.0|0.127|0.337|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 20 mcg qd minus Placebo|||0.337|0.127|<0.0001
72359452|NCT00467740|144230502|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.079|STANDARD_ERROR_OF_MEAN|0.056||0.1585||95.0|-0.031|0.188|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 2 mcg qd minus Placebo|||0.188|-0.031|0.1585
72359453|NCT00467740|144230502|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.097|STANDARD_ERROR_OF_MEAN|0.056||0.0848||95.0|-0.013|0.207|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 5 mcg qd minus Placebo|||0.207|-0.013|0.0848
72359454|NCT00467740|144230502|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.097|STANDARD_ERROR_OF_MEAN|0.056||0.0838||95.0|-0.013|0.207|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 10 mcg qd minus Placebo|||0.207|-0.013|0.0838
72359455|NCT00467740|144230502|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.18|STANDARD_ERROR_OF_MEAN|0.056||0.0014||95.0|0.07|0.289|||Mixed Models Analysis||Olo 20 mcg qd minus Placebo|||0.289|0.070|0.0014
72359456|NCT00467740|144230503|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.099|STANDARD_ERROR_OF_MEAN|0.059||0.0959||95.0|-0.018|0.216|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 2 mcg qd minus Placebo|||0.216|-0.018|0.0959
72359457|NCT00467740|144230503|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.119|STANDARD_ERROR_OF_MEAN|0.06||0.047||95.0|0.002|0.237|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 5 mcg qd minus Placebo|||0.237|0.002|0.0470
72359458|NCT00467740|144230503|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.077|STANDARD_ERROR_OF_MEAN|0.06||0.196||95.0|-0.04|0.195|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 10 mcg qd minus Placebo|||0.195|-0.040|0.1960
72359459|NCT00467740|144230503|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.185|STANDARD_ERROR_OF_MEAN|0.059||0.002||95.0|0.068|0.302|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 20 mcg qd minus Placebo|||0.302|0.068|0.0020
72359460|NCT00467740|144230504|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.143|STANDARD_ERROR_OF_MEAN|0.064||0.027||95.0|0.016|0.269|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 2 mcg qd minus Placebo|||0.269|0.016|0.0270
72359461|NCT00467740|144230504|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.106|STANDARD_ERROR_OF_MEAN|0.065||0.1031||95.0|-0.021|0.233|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 5 mcg qd minus Placebo|||0.233|-0.021|0.1031
72359462|NCT00467740|144230504|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.064||0.4378||95.0|-0.077|0.177|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 10 mcg qd minus Placebo|||0.177|-0.077|0.4378
72359463|NCT00467740|144230504|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.176|STANDARD_ERROR_OF_MEAN|0.064||0.0064||95.0|0.05|0.303|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 20 mcg qd minus Placebo|||0.303|0.050|0.0064
72359464|NCT00467740|144230505|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.075|STANDARD_ERROR_OF_MEAN|0.069||0.2781||95.0|-0.061|0.21|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 2 mcg qd minus Placebo|||0.210|-0.061|0.2781
72359465|NCT00467740|144230505|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.068|STANDARD_ERROR_OF_MEAN|0.069||0.3284||95.0|-0.068|0.204|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 5 mcg qd minus Placebo|||0.204|-0.068|0.3284
72359466|NCT00467740|144230505|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.036|STANDARD_ERROR_OF_MEAN|0.069||0.602||95.0|-0.1|0.171|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 10 mcg qd minus Placebo|||0.171|-0.100|0.6020
72359467|NCT00467740|144230505|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.24|STANDARD_ERROR_OF_MEAN|0.069||0.0006||95.0|0.104|0.375|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 20 mcg qd minus Placebo|||0.375|0.104|0.0006
72359468|NCT00467740|144230506|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.052|STANDARD_ERROR_OF_MEAN|0.067||0.4331|TWO_SIDED|95.0|-0.079|0.184|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 2 mcg qd minus Placebo|||0.184|-0.079|0.4331
72359469|NCT00467740|144230506|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.044|STANDARD_ERROR_OF_MEAN|0.068||0.515|TWO_SIDED|95.0|-0.089|0.178|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 5 mcg qd minus Placebo|||0.178|-0.089|0.5150
72359470|NCT00467740|144230506|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.038|STANDARD_ERROR_OF_MEAN|0.068||0.5714|TWO_SIDED|95.0|-0.095|0.171|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 10 mcg qd minus Placebo|||0.171|-0.095|0.5714
72359471|NCT00467740|144230506|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.162|STANDARD_ERROR_OF_MEAN|0.068||0.0177|TWO_SIDED|95.0|0.028|0.296|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 20 mcg qd minus Placebo|||0.296|0.028|0.0177
72359472|NCT00467740|144230507|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|22.97|STANDARD_ERROR_OF_MEAN|7.665||0.003|TWO_SIDED|95.0|7.883|38.057|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 2 mcg qd minus Placebo|||38.057|7.883|0.0030
72359473|NCT00467740|144230507|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|24.6|STANDARD_ERROR_OF_MEAN|7.7||0.0016|TWO_SIDED|95.0|9.446|39.754|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 5 mcg qd minus Placebo|||39.754|9.446|0.0016
72359474|NCT00467740|144230507|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|36.806|STANDARD_ERROR_OF_MEAN|7.727|<|0.0001|TWO_SIDED|95.0|21.598|52.015|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 10 mcg qd minus Placebo|||52.015|21.598|<.0001
72359475|NCT00467740|144230507|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|42.505|STANDARD_ERROR_OF_MEAN|7.675|<|0.0001|TWO_SIDED|95.0|27.399|57.611|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 20 mcg qd minus Placebo|||57.611|27.399|<.0001
72359476|NCT00467740|144230508|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.118|STANDARD_ERROR_OF_MEAN|1.055||0.2898|TWO_SIDED|95.0|-3.194|0.957|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 2 mcg qd minus Placebo|||0.957|-3.194|0.2898
72359477|NCT00467740|144230508|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.351|STANDARD_ERROR_OF_MEAN|1.057||0.027|TWO_SIDED|95.0|-4.432|-0.269|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 5 mcg qd minus Placebo|||-0.269|-4.432|0.0270
72359478|NCT00467740|144230508|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.045|STANDARD_ERROR_OF_MEAN|1.063||0.0045|TWO_SIDED|95.0|-5.138|-0.952|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 10 mcg qd minus Placebo|||-0.952|-5.138|0.0045
72359479|NCT00467740|144230508|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.937|STANDARD_ERROR_OF_MEAN|1.053||0.0056|TWO_SIDED|95.0|-5.01|-0.865|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 20 mcg qd minus Placebo|||-0.865|-5.010|0.0056
72359480|NCT00467740|144230509|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.287|STANDARD_ERROR_OF_MEAN|0.257||0.2645|TWO_SIDED|95.0|-0.793|0.218|||ANCOVA|Analysis of covariance model with terms for baseline, treatment, centre (centre random, all other effects fixed)|Olo 2 mcg qd minus Placebo|||0.218|-0.793|0.2645
72359481|NCT00467740|144230509|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.526|STANDARD_ERROR_OF_MEAN|0.258||0.0423|TWO_SIDED|95.0|-1.034|-0.018|||ANCOVA|Analysis of covariance model with terms for baseline, treatment, centre (centre random, all other effects fixed)|Olo 5 mcg qd minus Placebo|||-0.018|-1.034|0.0423
72359482|NCT00467740|144230509|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.332|STANDARD_ERROR_OF_MEAN|0.259||0.2008|TWO_SIDED|95.0|-0.842|0.178|||ANCOVA|Analysis of covariance model with terms for baseline, treatment, centre (centre random, all other effects fixed)|Olo 10 mcg qd minus Placebo|||0.178|-0.842|0.2008
72359483|NCT00467740|144230509|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.593|STANDARD_ERROR_OF_MEAN|0.257||0.0218|TWO_SIDED|95.0|-1.098|-0.087|||ANCOVA|Analysis of covariance model with terms for baseline, treatment, centre (centre random, all other effects fixed)|Olo 20 mcg qd minus Placebo|||-0.087|-1.098|0.0218
72359484|NCT00467740|144230518|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.142|STANDARD_ERROR_OF_MEAN|0.114||0.2156||95.0|-0.368|0.083|||ANCOVA|Analysis of covariance model with terms for baseline, treatment, centre (centre random, all other effects fixed)|Olo 2 mcg qd minus Placebo|||0.083|-0.368|0.2156
72359485|NCT00467740|144230518|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.197|STANDARD_ERROR_OF_MEAN|0.114||0.0869||95.0|-0.422|0.029|||ANCOVA|Analysis of covariance model with terms for baseline, treatment, centre (centre random, all other effects fixed)|Olo 5 mcg qd minus Placebo|||0.029|-0.422|0.0869
72359486|NCT00467740|144230518|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.328|STANDARD_ERROR_OF_MEAN|0.114||0.0044||95.0|-0.552|-0.103|||ANCOVA|Analysis of covariance model with terms for baseline, treatment, centre (centre random, all other effects fixed)|Olo 10 mcg qd minus Placebo|||-0.103|-0.552|0.0044
72359487|NCT00467740|144230518|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.276|STANDARD_ERROR_OF_MEAN|0.113||0.0158||95.0|-0.499|-0.052|||ANCOVA|Analysis of covariance model with terms for baseline, treatment, centre (centre random, all other effects fixed)|Olo 20 mcg qd minus Placebo|||-0.052|-0.499|0.0158
72359488|NCT02374164|144230546|SUPERIORITY_OR_OTHER||Point Estimate|0.72|||||TWO_SIDED|90.0|0.612|0.847|||||Ratio Fed/Fasted. Point estimate and 90% CI were obtained from the exponentiated results of analysis of the natural logarithm-transformed data. Bioequivalence was reached if the value was 0.80 to 1.25.|Relative bioavailability of a single dose of Febuxostat XR 80 mg in the fasted and fed (high-fat meal) states.||0.847|0.612|
72359489|NCT04678115|144230569|OTHER|Power Calculation: Sample size was estimated based on the treatment condition (three-level factor) effect size on the spontaneous blink IPF measurements (0.55) after eight participants had completed the crossover using one-way analysis of variance power calculation. This led to a sample size of 12 participants with power of 0.80 and type II error of alpha 0.05. To account for possible attrition, 16 were enrolled, with 15 completing the crossover.|||||<|0.001||||||a priori threshold for statistical significance was p\<0.05|Mixed Models Analysis|||Linear mixed-effects regression was used to determine the effect of treatment condition on the spontaneous blink and resting state open IPF, with participant as random intercept. Covariates of age, gender, blink sequence, and crossover order were investigated alone, and significant (P \< 0.05) covariates were included in the final model, from which the estimated marginal means and their 95% confidence interval were reported. Hypothesis: MLP allows a more complete spontaneous blink.||||<0.001
72359490|NCT04678115|144230570|OTHER|||||||0.001|||||||Mixed Models Analysis|||Hypothesis was that both devices (MLP and KFTS) would open the eye equally well, and that both would be better than sham treatment.||||0.001
72359491|NCT04678115|144230571|OTHER|||||||0.001|||||||test of proportionality|||A test of proportionality was performed to determine the effect of the three treatments on the probability of the eyelid not fully closing.||||0.001
72359492|NCT01168349|144230575|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.55|||||TWO_SIDED|95.0|0.42|0.71||||||||0.71|0.42|
72359493|NCT01168349|144230578|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Log Rank|||||||<0.0001
72359494|NCT03535974|144230605|OTHER||Mean Difference (Final Values)|10.57|STANDARD_ERROR_OF_MEAN|5.122||0.047|TWO_SIDED||||||t-test, 2 sided|||||||0.047
72359495|NCT00844376|144230607|SUPERIORITY_OR_OTHER_LEGACY||ratio of adjusted geometric means|95.77||||||90.0|85.82|106.88|||Mixed Models Analysis|The mixed effects model was implemented using SAS Proc Mixed, with REML estimation method and Kenward-Roger degrees of freedom algorithm.|Natural log transformed AUC48 was analyzed using a mixed effect model with sequence, period and treatment as a fixed effect and subject within sequence as a random effect.|Ratio of adjusted means (test/reference), and 90% CI for ratio--for AUC48; restricted (residual) maximum likelihood (REML) method of estimation.||106.88|85.82|
72359496|NCT00844376|144230608|SUPERIORITY_OR_OTHER_LEGACY||ratio of adjusted geometric means|95.04||||||90.0|84.99|106.27|||Mixed Models Analysis|The mixed effects model was implemented using SAS Proc Mixed, with REML estimation method and Kenward-Roger degrees of freedom algorithm.|Natural log transformed AUCinf was analyzed using a mixed effect model with sequence, period and treatment as a fixed effect and subject within sequence as a random effect.|Ratio of adjusted means (test/reference), and 90% CI for ratio--for AUCinf||106.27|84.99|
72359497|NCT00844376|144230609|SUPERIORITY_OR_OTHER_LEGACY||ratio of adjusted geometric means|94.86||||||90.0|83.86|107.29|||Mixed Models Analysis|The mixed effects model was implemented using SAS Proc Mixed, with REML estimation method and Kenward-Roger degrees of freedom algorithm.|Natural log transformed AUClast was analyzed using a mixed effect model with sequence, period and treatment as a fixed effect and subject within sequence as a random effect.|Ratio of adjusted means (test/reference), and 90% CI for ratio--for AUClast||107.29|83.86|
72359498|NCT00844376|144230610|SUPERIORITY_OR_OTHER_LEGACY||ratio of adjusted geometric means|117.9||||||90.0|98.22|141.53|||Mixed Models Analysis|The mixed effects model was implemented using SAS Proc Mixed, with REML estimation method and Kenward-Roger degrees of freedom algorithm.|Natural log transformed Cmax was analyzed using a mixed effect model with sequence, period and treatment as a fixed effect and subject within sequence as a random effect.|Ratio of adjusted means (test/reference), and 90% CI for ratio--for Cmax||141.53|98.22|
72359499|NCT00988884|144230639|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority of concomitant versus non-concomitant vaccination is demonstrated if the lower limit of the 95% confidence interval for the fold difference is \>0.5|Fold difference in GMT|0.97|||<|0.001|TWO_SIDED|95.0|0.88|1.08|||ANOVA|||Anti-HPV 6||1.08|0.88|<0.001
72359500|NCT00988884|144230639|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority of concomitant versus non-concomitant vaccination is demonstrated if the lower limit of the 95% confidence interval for the fold difference is \>0.5|Fold difference in GMT|0.97|||<|0.001|TWO_SIDED|95.0|0.87|1.07|||ANOVA|||Anti-HPV 11||1.07|0.87|<0.001
72359501|NCT00988884|144230639|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority of concomitant versus non-concomitant vaccination is demonstrated if the lower limit of the 95% confidence interval for the fold difference is \>0.5|Fold difference in GMT|0.98|||<|0.001|TWO_SIDED|95.0|0.89|1.09|||ANOVA|||Anti-HPV 16||1.09|0.89|<0.001
72359502|NCT00988884|144230639|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority of concomitant versus non-concomitant vaccination is demonstrated if the lower limit of the 95% confidence interval for the fold difference is \>0.5|Fold difference in GMT|0.99|||<|0.001|TWO_SIDED|95.0|0.88|1.12|||ANOVA|||Anti-HPV 18||1.12|0.88|<0.001
72359503|NCT00988884|144230639|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority of concomitant versus non-concomitant vaccination is demonstrated if the lower limit of the 95% confidence interval for the fold difference is \>0.5|Fold difference in GMT|1.04|||<|0.001|TWO_SIDED|95.0|0.93|1.17|||ANOVA|||Anti-HPV 31||1.17|0.93|<0.001
72359504|NCT00988884|144230639|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority of concomitant versus non-concomitant vaccination is demonstrated if the lower limit of the 95% confidence interval for the fold difference is \>0.5|Fold difference in GMT|0.99|||<|0.001|TWO_SIDED|95.0|0.89|1.11|||ANOVA|||Anti-HPV 33||1.11|0.89|<0.001
72359505|NCT00988884|144230639|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority of concomitant versus non-concomitant vaccination is demonstrated if the lower limit of the 95% confidence interval for the fold difference is \>0.5|Fold difference in GMT|1.1|||<|0.001|TWO_SIDED|95.0|0.97|1.25|||ANOVA|||Anti-HPV 45||1.25|0.97|<0.001
72359506|NCT00988884|144230639|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority of concomitant versus non-concomitant vaccination is demonstrated if the lower limit of the 95% confidence interval for the fold difference is \>0.5|Fold difference in GMT|0.98|||<|0.001|TWO_SIDED|95.0|0.88|1.1|||ANOVA|||Anti-HPV 52||1.10|0.88|<0.001
72359507|NCT00988884|144230639|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority of concomitant versus non-concomitant vaccination is demonstrated if the lower limit of the 95% confidence interval for the fold difference is \>0.5|Fold difference in GMT|0.99|||<|0.001|TWO_SIDED|95.0|0.88|1.1|||ANOVA|||Anti-HPV 58||1.10|0.88|<0.001
72359508|NCT00988884|144230640|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority of concomitant versus non-concomitant vaccination is demonstrated if the lower limit of the 97.5% confidence interval for the percentage difference is greater than -10|Difference in percentage|3.8|||<|0.001|TWO_SIDED|97.5|-1.7|9.3|||Miettinen and Nurminen|||Serogroup A||9.3|-1.7|<0.001
72359509|NCT00988884|144230640|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority of concomitant versus non-concomitant vaccination is demonstrated if the lower limit of the 97.5% confidence interval for the percentage difference is greater than -10|Difference in percentage|-2.1|||<|0.001|TWO_SIDED|97.5|-5.4|1.1|||Miettinen and Nurminen|||Serogroup C||1.1|-5.4|<0.001
72359510|NCT00988884|144230640|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority of concomitant versus non-concomitant vaccination is demonstrated if the lower limit of the 97.5% confidence interval for the percentage difference is greater than -10|Difference in percentage|2.1|||<|0.001|TWO_SIDED|97.5|-1.8|6.1|||Miettinen and Nurminen|||Serogroup Y||6.1|-1.8|<0.001
72359511|NCT00988884|144230640|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority of concomitant versus non-concomitant vaccination is demonstrated if the lower limit of the 97.5% confidence interval for the percentage difference is greater than -10|Difference in percentage|-2.1|||<|0.001|TWO_SIDED|97.5|-4.7|0.3|||Miettinen and Nurminen|||Serogroup W-135||0.3|-4.7|<0.001
72359512|NCT00988884|144230641|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority of concomitant versus non-concomitant vaccination is demonstrated if the lower limit of the 97.5% confidence interval for the percentage difference is greater than -10|Difference in percentage|0.0|||<|0.001|TWO_SIDED|97.5|-0.8|0.9|||Miettinen and Nurminen|||Anti-diphtheria titer \>=0.1 IU/mL||0.9|-0.8|<0.001
72359513|NCT00988884|144230641|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority of concomitant versus non-concomitant vaccination is demonstrated if the lower limit of the 97.5% confidence interval for the percentage difference is greater than -10|Difference in percentage|-0.2|||<|0.001|TWO_SIDED|97.5|-1.2|0.7|||Miettinen and Nurminen|||Anti-tetanus titer \>=0.1 IU/mL||0.7|-1.2|<0.001
72359514|NCT00988884|144230642|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority of concomitant versus non-concomitant vaccination is demonstrated if the lower limit of the 97.5% confidence interval for the fold difference is \>0.67|Fold difference in GMT|0.8||||0.003|TWO_SIDED|97.5|0.69|0.92|||ANOVA|||Anti-PT||0.92|0.69|0.003
72359515|NCT00988884|144230642|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority of concomitant versus non-concomitant vaccination is demonstrated if the lower limit of the 97.5% confidence interval for the fold difference is \>0.67|Fold difference in GMT|0.91|||<|0.001|TWO_SIDED|97.5|0.83|1.01|||ANOVA|||Anti-FHA||1.01|0.83|<0.001
72359516|NCT00988884|144230642|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority of concomitant versus non-concomitant vaccination is demonstrated if the lower limit of the 97.5% confidence interval for the fold difference is \>0.67|Fold difference in GMT|0.95|||<|0.001|TWO_SIDED|97.5|0.84|1.08|||ANOVA|||Anti-PRN||1.08|0.84|<0.001
72359517|NCT00988884|144230642|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority of concomitant versus non-concomitant vaccination is demonstrated if the lower limit of the 97.5% confidence interval for the fold difference is \>0.67|Fold difference in GMT|0.96|||<|0.001|TWO_SIDED|97.5|0.76|1.21|||ANOVA|||Anti-FIM 2/3||1.21|0.76|<0.001
72359518|NCT00988884|144230645|SUPERIORITY_OR_OTHER||Difference in percentage|-0.4||||0.806|TWO_SIDED|95.0|-3.5|2.7|||Miettinen and Nurminen|||||2.7|-3.5|0.806
72359519|NCT00549640|144230659|SUPERIORITY_OR_OTHER|||||||0.973||95.0|||||Fisher Exact|1-tailed||||||0.973
72359520|NCT00549640|144230660|SUPERIORITY_OR_OTHER|||||||0.5||95.0|||||Fisher Exact|1 tailed test||||||0.500
72359521|NCT00549640|144230661|SUPERIORITY_OR_OTHER|||||||0.65||95.0|||||t-test, 2 sided|For each subject, the average daily withdrawal score for the 14 days following target quit date was calculated and expressed as a change from baseline||||||0.65
72359522|NCT00549640|144230661|SUPERIORITY_OR_OTHER|||||||0.79||95.0|||||Mixed Models Analysis|analysis performed using daily scores||||||0.79
72359523|NCT04999839|144230674|SUPERIORITY||Odds Ratio (OR)|3.727|||=|0.052|TWO_SIDED|95.0|0.933|14.885||P-value was calculated using a Cochran-Mantel-Haenszel (CMH) test, with prior treatment with biologics included as a stratification factor, comparing the percentage of participants in each dose of NDI-034858 vs placebo.|Cochran-Mantel-Haenszel||Odds ratio for achievement of PASI-75 was calculated using the Mantel-Haenszel (MH) method.|||14.885|0.933|=0.052
72359524|NCT04999839|144230674|SUPERIORITY||Odds Ratio (OR)|12.733|||<|0.001|TWO_SIDED|95.0|3.525|45.994||P-value was calculated using a CMH test, with prior treatment with biologics included as a stratification factor, comparing the percentage of participants in each dose of NDI-034858 vs placebo.|Cochran-Mantel-Haenszel||Odds ratio for achievement of PASI-75 was calculated using the MH method.|||45.994|3.525|<0.001
72359525|NCT04999839|144230674|SUPERIORITY||Odds Ratio (OR)|29.014|||<|0.001|TWO_SIDED|95.0|8.526|98.735||P-value was calculated using a CMH test, with prior treatment with biologics included as a stratification factor, comparing the percentage of participants in each dose of NDI-034858 vs placebo.|Cochran-Mantel-Haenszel||Odds ratio for achievement of PASI-75 was calculated using the MH method.|||98.735|8.526|<0.001
72359526|NCT04999839|144230674|SUPERIORITY||Odds Ratio (OR)|40.111|||<|0.001|TWO_SIDED|95.0|10.277|156.548||P-value was calculated using a CMH test, with prior treatment with biologics included as a stratification factor, comparing the percentage of participants in each dose of NDI-034858 vs placebo.|Cochran-Mantel-Haenszel||Odds ratio for achievement of PASI-75 was calculated using the MH method.|||156.548|10.277|<0.001
72359527|NCT02675907|144230708|SUPERIORITY|||||||0.0034|||||||t-test, 2 sided|||||||0.0034
72359528|NCT02675907|144230709|SUPERIORITY||||||<|0.05||||||Row 1 (SPID6)|t-test, 2 sided|||||||<0.05
72359529|NCT02675907|144230709|SUPERIORITY||||||<|0.01||||||Row 2 (SPID12)|t-test, 2 sided|||||||<0.01
72359530|NCT02675907|144230709|SUPERIORITY||||||<|0.01||||||Row 3 (SPID24)|t-test, 2 sided|||||||<0.01
72359531|NCT02675907|144230709|SUPERIORITY||||||<|0.01||||||Row 4 (SPID12-48)|t-test, 2 sided|||||||<0.01
72359532|NCT02675907|144230709|SUPERIORITY||||||<|0.01||||||Row 5 (SPID24-48)|t-test, 2 sided|||||||<0.01
72359533|NCT02675907|144230710|SUPERIORITY|||||||0.0076|||||||Log Rank|||||||0.0076
72359534|NCT02675907|144230711|SUPERIORITY||||||<|0.001||||||Row 1 (Hour 0-24)|Cochran-Mantel-Haenszel|||||||<0.001
72359535|NCT02675907|144230711|SUPERIORITY||||||<|0.01||||||Row 2 (Hour 24-48)|Cochran-Mantel-Haenszel|||||||<0.01
72359536|NCT02675907|144230711|SUPERIORITY||||||<|0.01||||||Row 3 (Hour 0-48)|Cochran-Mantel-Haenszel|||||||<0.01
72359537|NCT02675907|144230712|SUPERIORITY||||||<|0.05||||||Row 1 (Hour 0-24)|ANCOVA|P-values were derived from ANCOVA models with fixed effects of treatment, baseline PI score, and investigational site||||||<0.05
72359538|NCT02675907|144230712|SUPERIORITY||||||<|0.05||||||Row 2 (Hour 24-48)|ANCOVA|P-values were derived from ANCOVA models with fixed effects of treatment, baseline PI score, and investigational site||||||<0.05
72359539|NCT02675907|144230712|SUPERIORITY||||||<|0.05||||||Row 3 (Hour 0-48)|ANCOVA|P-values were derived from ANCOVA models with fixed effects of treatment, baseline PI score, and investigational site||||||<0.05
72359540|NCT02675907|144230713|SUPERIORITY|||||||0.1228|||||||Log Rank|||||||0.1228
72359541|NCT02675907|144230714|SUPERIORITY|||||||0.1048|||||||Log Rank|||||||0.1048
72359542|NCT02675907|144230715|SUPERIORITY|||||||0.0451|||||||Cochran-Mantel-Haenszel|||||||0.0451
72359543|NCT02675907|144230716|SUPERIORITY|||||||0.0107|||||||Cochran-Mantel-Haenszel|||||||0.0107
72359544|NCT02675907|144230717|SUPERIORITY|||||||0.0781|||||||Cochran-Mantel-Haenszel|||||||0.0781
72359545|NCT02675907|144230718|SUPERIORITY|||||||0.043|||||||Cochran-Mantel-Haenszel|||||||0.0430
72359546|NCT02675907|144230719|SUPERIORITY|||||||0.107|||||||Cochran-Mantel-Haenszel|P-value was derived from comparisons between N1539 and Placebo via General Association of CMH Test controlling for investigational site||||||0.1070
72359547|NCT02675907|144230720|SUPERIORITY|||||||0.0046|||||||Cochran-Mantel-Haenszel|P-value was derived from comparisons between N1539 and Placebo via General Association of CMH Test controlling for investigational site||||||0.0046
72359548|NCT00539981|144230724|EQUIVALENCE|Equivalence between 2 lots for each strain was concluded if the 2-sided 95% CI for the ratio of post-vaccination GMTs for Lot A vs. B falls within 0.67 to 1.5.|GMT ratio|1.07||||0.009|TWO_SIDED|95.0|0.85|1.36||Threshold for significance of p value was 0.05.|ANOVA|||A/Solomon Islands (H1N1): FluBlok: Lot A versus FluBlok: Lot B||1.36|0.85|0.009
72359549|NCT00539981|144230724|EQUIVALENCE|Equivalence between 2 lots for each strain was concluded if the 2-sided 95% CI for the ratio of post-vaccination GMTs for Lot A vs. C falls within 0.67 to 1.5.|GMT ratio|0.91||||0.009|TWO_SIDED|0.91|0.71|1.15||Threshold for significance of p value was 0.05.|ANOVA|||A/Solomon Islands (H1N1): FluBlok: Lot A versus FluBlok: Lot C||1.15|0.71|0.009
72359550|NCT00539981|144230724|EQUIVALENCE|Equivalence between 2 lots for each strain was concluded if the 2-sided 95% CI for the ratio of post-vaccination GMTs for Lot B vs. C falls within 0.67 to 1.5.|GMT ratio|0.85||||0.009|TWO_SIDED|95.0|0.67|1.07|||ANOVA|Threshold for significance of p value was 0.05.||A/Solomon Islands (H1N1): FluBlok: Lot B versus FluBlok: Lot C||1.07|0.67|0.009
72359551|NCT00539981|144230724|EQUIVALENCE|Equivalence between 2 lots for each strain was concluded if the 2-sided 95% CI for the ratio of post-vaccination GMTs for Lot A vs. B falls within 0.67 to 1.5.|GMT ratio|2.03||||0.065|TWO_SIDED|95.0|1.56|2.64||Threshold of significance for p value was 0.05.|ANOVA|||A/Wisconsin (H3N2): FluBlok: Lot A versus FluBlok: Lot B||2.64|1.56|0.065
72359552|NCT00539981|144230724|EQUIVALENCE|Equivalence between 2 lots for each strain was concluded if the 2-sided 95% CI for the ratio of post-vaccination GMTs for Lot A vs. C falls within 0.67 to 1.5.|GMT ratio|1.63||||0.065|TWO_SIDED|95.0|1.26|2.11|||ANOVA|Threshold of significance for p value was 0.05.||A/Wisconsin (H3N2): FluBlok: Lot A versus FluBlok: Lot C||2.11|1.26|0.065
72359553|NCT00539981|144230724|EQUIVALENCE|Equivalence between 2 lots for each strain was concluded if the 2-sided 95% CI for the ratio of post-vaccination GMTs for Lot B vs. C falls within 0.67 to 1.5.|GMT ratio|0.8||||0.065|TWO_SIDED|95.0|0.62|1.04|||ANOVA|Threshold of significance for p value was 0.05.||A/Wisconsin (H3N2): FluBlok: Lot B versus FluBlok: Lot C||1.04|0.62|0.065
72359554|NCT00539981|144230724|EQUIVALENCE|Equivalence between 2 lots for each strain was concluded if the 2-sided 95% CI for the ratio of post-vaccination GMTs for Lot A vs. B falls within 0.67 to 1.5.|GMT ratio|0.88||||0.011|TWO_SIDED|95.0|0.69|1.13|||ANOVA|Threshold of significance for p value was 0.05.||B/Malaysia: FluBlok: Lot A versus FluBlok: Lot B||1.13|0.69|0.011
72359555|NCT00539981|144230724|EQUIVALENCE|Equivalence between 2 lots for each strain was concluded if the 2-sided 95% CI for the ratio of post-vaccination GMTs for Lot A vs. C falls within 0.67 to 1.5.|GMT ratio|0.85||||0.011|TWO_SIDED|95.0|0.65|1.09|||ANOVA|Threshold of significance for p value was 0.05.||B/Malaysia: FluBlok: Lot A versus FluBlok: Lot C||1.09|0.65|0.011
72359556|NCT00539981|144230724|EQUIVALENCE|Equivalence between 2 lots for each strain was concluded if the 2-sided 95% CI for the ratio of post-vaccination GMTs for Lot B vs. C falls within 0.67 to 1.5.|GMT ratio|0.96||||0.011|TWO_SIDED|95.0|0.75|1.23|||ANOVA|Threshold of significance for p value was 0.05.||B/Malaysia: FluBlok: Lot B versus FluBlok: Lot C||1.23|0.75|0.011
72359557|NCT00539981|144230725|SUPERIORITY|Relative protective efficacy is equivalent to absolute efficacy which is defined as the reduction in the influenza rate for Flublok relative to placebo.|Relative protective efficacy|75.4|||||TWO_SIDED|95.0|-148.0|99.5||||||FluBlok versus Placebo||99.5|-148.0|
72359558|NCT01611792|144230728|SUPERIORITY||Mean Difference (Net)|-10.0|STANDARD_DEVIATION|9.02|<|0.0001|TWO_SIDED||||||Mixed Models Analysis|||||||<.0001
72359559|NCT01611792|144230729|SUPERIORITY||Mean Difference (Net)|-6.67|STANDARD_DEVIATION|11.86||0.0038|TWO_SIDED||||||Mixed Models Analysis|||||||0.0038
72359560|NCT01611792|144230730|SUPERIORITY||Mean Difference (Net)|2.0|STANDARD_DEVIATION|5.36||0.36|TWO_SIDED||||||Mixed Models Analysis|||||||0.36
72359561|NCT01611792|144230731|SUPERIORITY||Mean Difference (Net)|-1.31|STANDARD_DEVIATION|1.98||0.0018|TWO_SIDED||||||Mixed Models Analysis|||||||0.0018
72359562|NCT01611792|144230732|SUPERIORITY||Mean Difference (Net)|0.69|STANDARD_DEVIATION|2.12||0.19|TWO_SIDED||||||Mixed Models Analysis|||||||0.19
72359563|NCT01611792|144230733|SUPERIORITY||Mean Difference (Net)|0.69|STANDARD_DEVIATION|2.12||0.19|TWO_SIDED||||||Mixed Models Analysis|||||||0.19
72359564|NCT00525512|144230736|SUPERIORITY_OR_OTHER||Adjusted mean ratio|1.13||||0.1062||95.0|0.97|1.32||Based on a MMRM analysis with terms for treatment, centre and baseline.|Mixed Models Analysis|||||1.32|0.97|0.1062
72359565|NCT00525512|144230737|SUPERIORITY_OR_OTHER||Adjusted mean ratio|1.12||||0.008||95.0|1.03|1.23||Based on a MMRM analysis with terms for treatment, centre and baseline.|Mixed Models Analysis|||||1.23|1.03|0.008
72359566|NCT00525512|144230738|SUPERIORITY_OR_OTHER||Adjusted mean ratio|1.1||||0.0597||95.0|1.0|1.21||Based on a MMRM analysis with terms for treatment, centre and baseline.|Mixed Models Analysis|||||1.21|1.00|0.0597
72359567|NCT00525512|144230739|SUPERIORITY_OR_OTHER||Adjusted mean ratio|1.15||||0.0131||95.0|1.03|1.29||Based on a MMRM analysis with terms for treatment, centre and baseline.|Mixed Models Analysis|||||1.29|1.03|0.0131
72359568|NCT00525512|144230740|SUPERIORITY_OR_OTHER||Adjusted mean ratio|1.18||||0.0041||95.0|1.05|1.32||Based on a MMRM analysis with terms for treatment, centre and baseline.|Mixed Models Analysis|||||1.32|1.05|0.0041
72359569|NCT00525512|144230741|SUPERIORITY_OR_OTHER||Adjusted mean ratio|1.11||||0.0945||95.0|0.98|1.26||Based on a MMRM analysis with terms for treatment, centre and baseline.|Mixed Models Analysis|||||1.26|0.98|0.0945
72359570|NCT00525512|144230742|SUPERIORITY_OR_OTHER||Adjusted mean ratio|1.12||||0.0899||95.0|0.98|1.28||Based on a MMRM analysis with terms for treatment, centre and baseline.|Mixed Models Analysis|||||1.28|0.98|0.0899
72359571|NCT00525512|144230743|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.116|||<|0.0001||95.0|0.073|0.16||Based on a MMRM analysis with terms for treatment, centre and baseline.|Mixed Models Analysis|||||0.160|0.073|<0.0001
72359572|NCT00525512|144230744|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.082||||0.0005||95.0|0.036|0.128||Based on a MMRM analysis with terms for treatment, centre and baseline.|Mixed Models Analysis|||||0.128|0.036|0.0005
72359573|NCT00525512|144230745|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.089||||0.0003||95.0|0.041|0.137||Based on a MMRM analysis with terms for treatment, centre and baseline.|Mixed Models Analysis|||||0.137|0.041|0.0003
72359574|NCT00525512|144230746|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.105|||<|0.0001||95.0|0.058|0.153||Based on a MMRM analysis with terms for treatment, centre and baseline.|Mixed Models Analysis|||||0.153|0.058|<0.0001
72359575|NCT00525512|144230747|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.09||||0.0005||95.0|0.04|0.141||Based on a MMRM analysis with terms for treatment, centre and baseline.|Mixed Models Analysis|||||0.141|0.040|0.0005
72359576|NCT00525512|144230748|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.094||||0.0002||95.0|0.045|0.144||Based on a MMRM analysis with terms for treatment, centre and baseline.|Mixed Models Analysis|||||0.144|0.045|0.0002
72359577|NCT00525512|144230749|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.075||||0.0059||95.0|0.022|0.128||Based on a MMRM analysis with terms for treatment, centre and baseline.|Mixed Models Analysis|||||0.128|0.022|0.0059
72359578|NCT00525512|144230750|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.154|||<|0.0001||95.0|0.11|0.198||Based on a MMRM analysis with terms for treatment, centre and baseline.|Mixed Models Analysis|||||0.198|0.110|<0.0001
72359579|NCT00525512|144230751|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.162|||<|0.0001||95.0|0.117|0.208||Based on a MMRM analysis with terms for treatment, centre and baseline.|Mixed Models Analysis|||||0.208|0.117|<0.0001
72359580|NCT00525512|144230752|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.145|||<|0.0001||95.0|0.099|0.192||Based on a MMRM analysis with terms for treatment, centre and baseline.|Mixed Models Analysis|||||0.192|0.099|<0.0001
72359581|NCT00525512|144230753|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.127|||<|0.0001||95.0|0.077|0.176||Based on a MMRM analysis with terms for treatment, centre and baseline.|Mixed Models Analysis|||||0.176|0.077|<0.0001
72359582|NCT00525512|144230754|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.134|||<|0.0001||95.0|0.083|0.185||Based on a MMRM analysis with terms for treatment, centre and baseline.|Mixed Models Analysis|||||0.185|0.083|<0.0001
72359583|NCT00525512|144230755|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.149|||<|0.0001||95.0|0.097|0.202||Based on a MMRM analysis with terms for treatment, centre and baseline.|Mixed Models Analysis|||||0.202|0.097|<0.0001
72359584|NCT00525512|144230756|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.13|||<|0.0001||95.0|0.077|0.183||Based on a MMRM analysis with terms for treatment, centre and baseline.|Mixed Models Analysis|||||0.183|0.077|<0.0001
72359585|NCT00525512|144230757|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.217|||<|0.0001||95.0|0.127|0.307||Based on a MMRM analysis with terms for treatment, centre and baseline.|Mixed Models Analysis|||||0.307|0.127|<0.0001
72359586|NCT00525512|144230758|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.157||||0.0019||95.0|0.058|0.255||Based on a MMRM analysis with terms for treatment, centre and baseline.|Mixed Models Analysis|||||0.255|0.058|0.0019
72359587|NCT00525512|144230759|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.182||||0.0006||95.0|0.078|0.286||Based on a MMRM analysis with terms for treatment, centre and baseline.|Mixed Models Analysis|||||0.286|0.078|0.0006
72359588|NCT00525512|144230760|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.234|||<|0.0001||95.0|0.13|0.339||Based on a MMRM analysis with terms for treatment, centre and baseline.|Mixed Models Analysis|||||0.339|0.130|<0.0001
72359589|NCT00525512|144230761|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.161||||0.009||95.0|0.04|0.281||Based on a MMRM analysis with terms for treatment, centre and baseline.|Mixed Models Analysis|||||0.281|0.040|0.009
72359590|NCT00525512|144230762|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.212||||0.0002||95.0|0.102|0.322||Based on a MMRM analysis with terms for treatment, centre and baseline.|Mixed Models Analysis|||||0.322|0.102|0.0002
72359591|NCT00525512|144230763|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.241|||<|0.0001||95.0|0.128|0.355||Based on a MMRM analysis with terms for treatment, centre and baseline.|Mixed Models Analysis|||||0.355|0.128|<0.0001
72359592|NCT00525512|144230764|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.277|||<|0.0001||95.0|0.179|0.375||Based on a MMRM analysis with terms for treatment, centre and baseline.|Mixed Models Analysis|||||0.375|0.179|<0.0001
72359593|NCT00525512|144230765|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.325|||<|0.0001||95.0|0.226|0.425||Based on a MMRM analysis with terms for treatment, centre and baseline.|Mixed Models Analysis|||||0.425|0.226|<0.0001
72359594|NCT00525512|144230766|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.353|||<|0.0001||95.0|0.245|0.461||Based on a MMRM analysis with terms for treatment, centre and baseline.|Mixed Models Analysis|||||0.461|0.245|<0.0001
72359595|NCT00525512|144230767|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.259|||<|0.0001||95.0|0.154|0.365||Based on a MMRM analysis with terms for treatment, centre and baseline.|Mixed Models Analysis|||||0.365|0.154|<0.0001
72359596|NCT00525512|144230768|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3|||<|0.0001||95.0|0.194|0.406||Based on a MMRM analysis with terms for treatment, centre and baseline.|Mixed Models Analysis|||||0.406|0.194|<0.0001
72359597|NCT00525512|144230769|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.254|||<|0.0001||95.0|0.144|0.364||Based on a MMRM analysis with terms for treatment, centre and baseline.|Mixed Models Analysis|||||0.364|0.144|<0.0001
72359598|NCT00525512|144230770|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.333|||<|0.0001||95.0|0.209|0.456||Based on a MMRM analysis with terms for treatment, centre and baseline.|Mixed Models Analysis|||||0.456|0.209|<0.0001
72359599|NCT00525512|144230771|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.32||||0.1131||95.0|-0.72|0.08||Based on a MMRM analysis with terms for treatment, centre and baseline.|Mixed Models Analysis|||||0.08|-0.72|0.1131
72359600|NCT00525512|144230772|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02||||0.9071||95.0|-0.38|0.33||Based on a MMRM analysis with terms for treatment, centre and baseline.|Mixed Models Analysis|||||0.33|-0.38|0.9071
72359601|NCT00525512|144230773|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.09||||0.6878||95.0|-0.35|0.53||Based on a MMRM analysis with terms for treatment, centre and baseline.|Mixed Models Analysis|||||0.53|-0.35|0.6878
72359602|NCT00525512|144230774|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.36||||||95.0|-2.39|3.11||Based on a MMRM analysis with terms for treatment, centre and baseline.||||||3.11|-2.39|
72359603|NCT00525512|144230775|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.33||||||95.0|-2.66|3.31||Based on a MMRM analysis with terms for treatment, centre and baseline.||||||3.31|-2.66|
72359604|NCT00525512|144230776|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.34||||||95.0|-2.91|3.58||Based on a MMRM analysis with terms for treatment, centre and baseline.||||||3.58|-2.91|
72359605|NCT00525512|144230777|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.23||||||95.0|-2.97|3.43||Based on a MMRM analysis with terms for treatment, centre and baseline.||||||3.43|-2.97|
72359606|NCT00525512|144230778|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.22||||||95.0|-3.02|3.46||Based on a MMRM analysis with terms for treatment, centre and baseline.||||||3.46|-3.02|
72359607|NCT00525512|144230779|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.16||||||95.0|-3.1|3.41||Based on a MMRM analysis with terms for treatment, centre and baseline.||||||3.41|-3.10|
72359608|NCT00525512|144230780|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.17||||||95.0|-3.22|3.55||Based on a MMRM analysis with terms for treatment, centre and baseline.||||||3.55|-3.22|
72359609|NCT00525512|144230781|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.37||||||95.0|-2.78|3.52||Based on a MMRM analysis with terms for treatment, centre and baseline.||||||3.52|-2.78|
72359610|NCT00525512|144230782|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.23||||||95.0|-3.05|3.51||Based on a MMRM analysis with terms for treatment, centre and baseline.||||||3.51|-3.05|
72359611|NCT00525512|144230783|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.08||||||95.0|-3.4|3.55||Based on a MMRM analysis with terms for treatment, centre and baseline.||||||3.55|-3.40|
72359612|NCT00525512|144230784|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.15||||||95.0|-3.61|3.92||Based on a MMRM analysis with terms for treatment, centre and baseline.||||||3.92|-3.61|
72359613|NCT00525512|144230785|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.18||||||95.0|-3.53|3.9||Based on a MMRM analysis with terms for treatment, centre and baseline.||||||3.90|-3.53|
72359614|NCT00525512|144230786|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.18||||||95.0|-3.36|3.71||Based on a MMRM analysis with terms for treatment, centre and baseline.||||||3.71|-3.36|
72359615|NCT00525512|144230787|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.07||||||95.0|-3.82|3.96||Based on a MMRM analysis with terms for treatment, centre and baseline.||||||3.96|-3.82|
72359616|NCT00525512|144230788|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.03||||0.0072||95.0|-6.97|-1.1||Based on a MMRM analysis with terms for treatment, centre and baseline.|Mixed Models Analysis|||||-1.10|-6.97|0.0072
72359617|NCT00525512|144230789|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.33||||0.2029||95.0|-5.91|1.26||Based on a MMRM analysis with terms for treatment, centre and baseline.|Mixed Models Analysis|||||1.26|-5.91|0.2029
72359618|NCT00525512|144230790|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.58||||0.0313||95.0|-6.84|-0.32||Based on a MMRM analysis with terms for treatment, centre and baseline.|Mixed Models Analysis|||||-0.32|-6.84|0.0313
72359619|NCT00525512|144230791|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.94||||0.0001||95.0|-13.37|-4.52||Based on a MMRM analysis with terms for treatment, centre and baseline.|Mixed Models Analysis|||||-4.52|-13.37|0.0001
72359620|NCT00525512|144230792|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.94||||0.6541||95.0|0.719|1.23||Based on a MMRM analysis with terms for treatment, centre and baseline.|Regression, Cox|||||1.230|0.719|0.6541
72359621|NCT00525512|144230793|SUPERIORITY_OR_OTHER||Adjusted mean ratio|1.06||||0.4443||95.0|0.91|1.25||Based on a ANCOVA analysis with terms for treatment, centre and baseline.|ANCOVA|||||1.25|0.91|0.4443
72359622|NCT00525512|144230794|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01||||0.8644||95.0|-0.05|0.06||Based on a ANCOVA analysis with terms for treatment, centre and baseline.|ANCOVA|||||0.06|-0.05|0.8644
72359623|NCT00525512|144230795|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.05||||0.4277||95.0|-0.07|0.17||Based on a ANCOVA analysis with terms for treatment, centre and baseline.|ANCOVA|||||0.17|-0.07|0.4277
72359624|NCT00525512|144230796|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.61||||0.7071||95.0|-3.81|2.59||Based on a ANCOVA analysis with terms for treatment, centre and baseline.|ANCOVA|||||2.59|-3.81|0.7071
72359625|NCT00525512|144230797|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.89||||0.6556||95.0|-3.03|4.81||Based on a ANCOVA analysis with terms for treatment, centre and baseline.|ANCOVA|||||4.81|-3.03|0.6556
72359626|NCT00525512|144230798|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.02||||0.9896||95.0|-3.44|3.48||Based on a ANCOVA analysis with terms for treatment, centre and baseline.|ANCOVA|||||3.48|-3.44|0.9896
72359627|NCT00525512|144230799|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.33||||0.0807||95.0|-9.19|0.53||Based on a ANCOVA analysis with terms for treatment, centre and baseline.|ANCOVA|||||0.53|-9.19|0.0807
72359628|NCT00402168|144230855|SUPERIORITY_OR_OTHER||Difference in Percentage|7.1|||||TWO_SIDED|95.0|2.1|14.9||||||At Month 6, difference in percentage of participants with acute rejection (number with acute rejection/number randomized) using exact method.||14.9|2.1|
72359629|NCT00402168|144230855|SUPERIORITY_OR_OTHER||Difference in Percentage|7.1|||||TWO_SIDED|95.0|2.1|14.9||||||At Month 12, difference in percentage of participants with acute rejection using exact method.||14.9|2.1|
72359630|NCT00402168|144230856|SUPERIORITY_OR_OTHER||Percent Difference|1.1|||||TWO_SIDED|95.0|-3.3|6.1||||||Participants surviving with a functioning graft by Month 6: For 95% Confidence Interval (CI) of difference, exact method was used.||6.1|-3.3|
72359631|NCT00402168|144230856|SUPERIORITY_OR_OTHER||Percent Difference|1.1|||||TWO_SIDED|95.0|-3.3|6.1||||||Participants surviving with a functioning graft by Month 12: For 95% CI of difference, exact method was used.||6.1|-3.3|
72359632|NCT00402168|144230859|SUPERIORITY_OR_OTHER||Difference|6.0|||||TWO_SIDED|95.0|-0.1|13.8||||||||13.8|-0.1|
72359633|NCT00402168|144230864|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.1||||0.4491|TWO_SIDED|95.0|-1.7|3.9|||ANCOVA|||Mental Component Scales (MCS)||3.9|-1.7|0.4491
72359634|NCT00402168|144230864|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.3||||0.7892|TWO_SIDED|95.0|-2.5|1.9|||ANCOVA|||Physical Component Scales (PCS)||1.9|-2.5|0.7892
72359635|NCT00402168|144230866|SUPERIORITY_OR_OTHER||Estimated Difference|0.0076|||||TWO_SIDED|95.0|-0.01|0.0252||||||Difference in Symptom Occurrence between treatment groups.||.0252|-.010|
72359636|NCT00402168|144230866|SUPERIORITY_OR_OTHER||Estimated Difference|0.0148|||||TWO_SIDED|95.0|-0.002|0.0321||||||Difference in Symptom Distress between treatment groups.||.0321|-.002|
72359637|NCT00395746|144230886|SUPERIORITY_OR_OTHER||Least Squares Mean|-1.27|||<|0.0001||95.0|-1.51|1.02||A significance level of a two-sided 5% was used for statistical hypothesis testing.|ANOVA|||"ANOVA model included treatment group and pre-trial SU as fixed effects and HbA1C at baseline as a covariate. Two null hypotheses were statistically tested:~H10: μ0.9 = μSU, H11: μ0.9 ≠ μSU H20: μ0.6 = μSU, H21: μ0.6 ≠ μSU where μ0.6, μ0.9 and μSU are population mean after 24-week treatment for 0.6 mg+SU, 0.9 mg+SU and SU mono, respectively. When the test of comparison between 0.9 mg+SU and SU mono was significant, the test of comparison between 0.6 mg+SU and SU mono was performed."||1.02|-1.51|<0.0001
72359638|NCT00395746|144230886|SUPERIORITY_OR_OTHER||Least Squares Mean|-1.0|||<|0.0001||95.0|-1.24|-0.75|||ANOVA|A significance level of a two-sided 5% was used for statistical hypothesis testing.||"ANOVA model included treatment group and pre-trial SU as fixed effects and HbA1C at baseline as a covariate. Two null hypotheses were statistically tested:~H10: μ0.9 = μSU, H11: μ0.9 ≠ μSU H20: μ0.6 = μSU, H21: μ0.6 ≠ μSU where μ0.6, μ0.9 and μSU are population mean after 24-week treatment for 0.6 mg+SU, 0.9 mg+SU and SU mono, respectively. When the test of comparison between 0.9 mg+SU and SU mono was significant, the test of comparison between 0.6 mg+SU and SU mono was performed."||-0.75|-1.24|<0.0001
72359639|NCT00395746|144230887|SUPERIORITY_OR_OTHER||Least Squares Mean|-1.33||||||95.0|-1.62|-1.04|||ANOVA|||95% confidence interval for the mean difference (each liraglutide - SU monotherapy) was calculated under an analysis of variance (ANOVA) model with treatment group and pre-trial SU as fixed effects and corresponding baseline value as a covariate, and no statistical testing was performed.||-1.04|-1.62|
72359640|NCT00395746|144230887|SUPERIORITY_OR_OTHER||Least Squares Mean|-0.96||||||95.0|-1.25|-0.67|||ANOVA|||95% confidence interval for the mean difference (each liraglutide - SU monotherapy) was calculated under an analysis of variance (ANOVA) model with treatment group and pre-trial SU as fixed effects and corresponding baseline value as a covariate, and no statistical testing was performed.||-0.67|-1.25|
72359641|NCT00395746|144230888|SUPERIORITY_OR_OTHER||Least Squares Mean|-32.4|||<|0.0001||95.0|-40.5|-24.2||To perform the pairwise comparisons simultaneously, a closed testing procedure was applied. When the hypothesis μ0.9 = μ0.6 = μSU was rejected, the 2 hypotheses of pairwise comparison were tested simultaneously both at significance level of 5%.|ANOVA|||ANOVA model included treatment group and pre-trial SU as fixed effects and corresponding baseline value as a covariate. Two null hypotheses were statistically tested, when the hypothesis μ0.9 = μ0.6 = μSU was rejected at a significance level of 5%: H10: μ0.9 = μSU, H11: μ0.9 ≠ μSU H20: μ0.6 = μSU, H21: μ0.6 ≠ μSU where μ0.6, μ0.9 and μSU are population mean after 24-week treatment for 0.6 mg+SU, 0.9 mg+SU and SU mono, respectively.||-24.2|-40.5|<0.0001
72359642|NCT00395746|144230888|SUPERIORITY_OR_OTHER||Least Squares Mean|-26.4|||<|0.0001||95.0|-34.5|-18.2||To perform the pairwise comparisons simultaneously, a closed testing procedure was applied. When the hypothesis μ0.9 = μ0.6 = μSU was rejected, the 2 hypotheses of pairwise comparison were tested simultaneously both at significance level of 5%.|ANOVA|||ANOVA model included treatment group and pre-trial SU as fixed effects and corresponding baseline value as a covariate. Two null hypotheses were statistically tested, when the hypothesis μ0.9 = μ0.6 = μSU was rejected at a significance level of 5%: H10: μ0.9 = μSU, H11: μ0.9 ≠ μSU H20: μ0.6 = μSU, H21: μ0.6 ≠ μSU where μ0.6, μ0.9 and μSU are population mean after 24-week treatment for 0.6 mg+SU, 0.9 mg+SU and SU mono, respectively.||-18.2|-34.5|<0.0001
72359643|NCT00395746|144230889|SUPERIORITY_OR_OTHER||Least Squares Mean|-30.2||||||95.0|-39.6|-20.7|||ANOVA|||95% confidence interval for the mean difference (each liraglutide - SU monotherapy) was calculated under an analysis of variance (ANOVA) model with treatment group and pre-trial SU as fixed effects and corresponding baseline value as a covariate, and no statistical testing was performed.||-20.7|-39.6|
72359644|NCT00395746|144230889|SUPERIORITY_OR_OTHER||Least Squares Mean|-24.4||||||95.0|-33.8|-14.9|||ANOVA|||95% confidence interval for the mean difference (each liraglutide - SU monotherapy) was calculated under an analysis of variance (ANOVA) model with treatment group and pre-trial SU as fixed effects and corresponding baseline value as a covariate, and no statistical testing was performed.||-14.9|-33.8|
72359645|NCT00395746|144230890|SUPERIORITY_OR_OTHER||Least Squares Mean|-150.22|||<|0.0001||95.0|-186.32|-114.12||To perform the pairwise comparisons simultaneously, a closed testing procedure was applied. When the hypothesis μ0.9 = μ0.6 = μSU was rejected, the 2 hypotheses of pairwise comparison were tested simultaneously both at significance level of 5%.|ANOVA|||"ANOVA model included treatment group and pre-trial SU as fixed effects and corresponding baseline value as a covariate. Two null hypotheses were statistically tested, when the hypothesis μ0.9 = μ0.6 = μSU was rejected at a significance level of 5%:~H10: μ0.9 = μSU, H11: μ0.9 ≠ μSU H20: μ0.6 = μSU, H21: μ0.6 ≠ μSU where μ0.6, μ0.9 and μSU are population mean after 24-week treatment for 0.6 mg+SU, 0.9 mg+SU and SU mono, respectively."||-114.12|-186.32|<0.0001
72359646|NCT00395746|144230890|SUPERIORITY_OR_OTHER||Least Squares Mean|-111.15|||<|0.0001||95.0|-147.61|-74.68||To perform the pairwise comparisons simultaneously, a closed testing procedure was applied. When the hypothesis μ0.9 = μ0.6 = μSU was rejected, the 2 hypotheses of pairwise comparison were tested simultaneously both at significance level of 5%.|ANOVA|||"ANOVA model included treatment group and pre-trial SU as fixed effects and corresponding baseline value as a covariate. Two null hypotheses were statistically tested, when the hypothesis μ0.9 = μ0.6 = μSU was rejected at a significance level of 5%:~H10: μ0.9 = μSU, H11: μ0.9 ≠ μSU H20: μ0.6 = μSU, H21: μ0.6 ≠ μSU where μ0.6, μ0.9 and μSU are population mean after 24-week treatment for 0.6 mg+SU, 0.9 mg+SU and SU mono, respectively."||-74.68|-147.61|<0.0001
72359647|NCT00395746|144230891|SUPERIORITY_OR_OTHER||Least Squares Mean|-127.57||||||95.0|-166.91|-88.24|||ANOVA|||95% confidence interval for the mean difference (each liraglutide - SU monotherapy) was calculated under an analysis of variance (ANOVA) model with treatment group and pre-trial SU as fixed effects and corresponding baseline value as a covariate, and no statistical testing was performed.||-88.24|-166.91|
72359648|NCT00395746|144230891|SUPERIORITY_OR_OTHER||Least Squares Mean|-68.68||||||95.0|-108.91|-28.45|||ANOVA|||95% confidence interval for the mean difference (each liraglutide - SU monotherapy) was calculated under an analysis of variance (ANOVA) model with treatment group and pre-trial SU as fixed effects and corresponding baseline value as a covariate, and no statistical testing was performed.||-28.45|-108.91|
72359649|NCT00395746|144230892|SUPERIORITY_OR_OTHER||Least Squares Mean|-44.45|||<|0.0001||95.0|-55.02|-33.89||To perform the pairwise comparisons simultaneously, a closed testing procedure was applied. When the hypothesis μ0.9 = μ0.6 = μSU was rejected, the 2 hypotheses of pairwise comparison were tested simultaneously both at significance level of 5%.|ANOVA|||"ANOVA model included treatment group and pre-trial SU as fixed effects and corresponding baseline value as a covariate. Two null hypotheses were statistically tested, when the hypothesis μ0.9 = μ0.6 = μSU was rejected at a significance level of 5%:~H10: μ0.9 = μSU, H11: μ0.9 ≠ μSU H20: μ0.6 = μSU, H21: μ0.6 ≠ μSU where μ0.6, μ0.9 and μSU are population mean after 24-week treatment for 0.6 mg+SU, 0.9 mg+SU and SU mono, respectively."||-33.89|-55.02|<0.0001
72359650|NCT00395746|144230892|SUPERIORITY_OR_OTHER||Least Squares Mean|-34.3|||<|0.0001||95.0|-45.06|-23.54||To perform the pairwise comparisons simultaneously, a closed testing procedure was applied. When the hypothesis μ0.9 = μ0.6 = μSU was rejected, the 2 hypotheses of pairwise comparison were tested simultaneously both at significance level of 5%.|ANOVA|||"ANOVA model included treatment group and pre-trial SU as fixed effects and corresponding baseline value as a covariate. Two null hypotheses were statistically tested, when the hypothesis μ0.9 = μ0.6 = μSU was rejected at a significance level of 5%:~H10: μ0.9 = μSU, H11: μ0.9 ≠ μSU H20: μ0.6 = μSU, H21: μ0.6 ≠ μSU where μ0.6, μ0.9 and μSU are population mean after 24-week treatment for 0.6 mg+SU, 0.9 mg+SU and SU mono, respectively."||-23.54|-45.06|<0.0001
72359651|NCT00395746|144230893|SUPERIORITY_OR_OTHER||Least Squares Mean|-34.49||||||95.0|-46.77|-22.22|||ANOVA|||95% confidence interval for the mean difference (each liraglutide - SU monotherapy) was calculated under an analysis of variance (ANOVA) model with treatment group and pre-trial SU as fixed effects and corresponding baseline value as a covariate, and no statistical testing was performed.||-22.22|-46.77|
72359652|NCT00395746|144230893|SUPERIORITY_OR_OTHER||Least Squares Mean|-46.34||||||95.0|-58.49|-34.18|||ANOVA|||95% confidence interval for the mean difference (each liraglutide - SU monotherapy) was calculated under an analysis of variance (ANOVA) model with treatment group and pre-trial SU as fixed effects and corresponding baseline value as a covariate, and no statistical testing was performed.||-34.18|-58.49|
72359653|NCT00395746|144230894|SUPERIORITY_OR_OTHER||Least Squares Mean|-11.37||||0.0433||95.0|-22.4|-0.34||To perform the pairwise comparisons simultaneously, a closed testing procedure was applied. When the hypothesis μ0.9 = μ0.6 = μSU was rejected, the 2 hypotheses of pairwise comparison were tested simultaneously both at significance level of 5%.|ANOVA|||"ANOVA model included treatment group and pre-trial SU as fixed effects and corresponding baseline value as a covariate. Two null hypotheses were statistically tested, when the hypothesis μ0.9 = μ0.6 = μSU was rejected at a significance level of 5%:~H10: μ0.9 = μSU, H11: μ0.9 ≠ μSU H20: μ0.6 = μSU, H21: μ0.6 ≠ μSU where μ0.6, μ0.9 and μSU are population mean after 24-week treatment for 0.6 mg+SU, 0.9 mg+SU and SU mono, respectively."||-0.34|-22.40|0.0433
72359654|NCT00395746|144230894|SUPERIORITY_OR_OTHER||Least Squares Mean|6.67||||0.2359||95.0|-4.39|17.73||To perform the pairwise comparisons simultaneously, a closed testing procedure was applied. When the hypothesis μ0.9 = μ0.6 = μSU was rejected, the 2 hypotheses of pairwise comparison were tested simultaneously both at significance level of 5%.|ANOVA|||"ANOVA model included treatment group and pre-trial SU as fixed effects and corresponding baseline value as a covariate. Two null hypotheses were statistically tested, when the hypothesis μ0.9 = μ0.6 = μSU was rejected at a significance level of 5%:~H10: μ0.9 = μSU, H11: μ0.9 ≠ μSU H20: μ0.6 = μSU, H21: μ0.6 ≠ μSU where μ0.6, μ0.9 and μSU are population mean after 24-week treatment for 0.6 mg+SU, 0.9 mg+SU and SU mono, respectively."||17.73|-4.39|0.2359
72359655|NCT00395746|144230895|SUPERIORITY_OR_OTHER||Least Squares Mean|-13.3||||||95.0|-24.69|-1.9|||ANOVA|||95% confidence interval for the mean difference (each liraglutide - SU monotherapy) was calculated under an analysis of variance (ANOVA) model with treatment group and pre-trial SU as fixed effects and corresponding baseline value as a covariate, and no statistical testing was performed.||-1.90|-24.69|
72359656|NCT00395746|144230895|SUPERIORITY_OR_OTHER||Least Squares Mean|-7.11||||||95.0|-18.42|4.21|||ANOVA|||95% confidence interval for the mean difference (each liraglutide - SU monotherapy) was calculated under an analysis of variance (ANOVA) model with treatment group and pre-trial SU as fixed effects and corresponding baseline value as a covariate, and no statistical testing was performed.||4.21|-18.42|
72359657|NCT00395746|144230896|SUPERIORITY_OR_OTHER||Least Squares Mean|0.75||||0.0071||95.0|0.21|1.3||To perform the pairwise comparisons simultaneously, a closed testing procedure was applied. When the hypothesis μ0.9 = μ0.6 = μSU was rejected, the 2 hypotheses of pairwise comparison were tested simultaneously both at significance level of 5%.|ANOVA|||"ANOVA model included treatment group and pre-trial SU as fixed effects and corresponding baseline value as a covariate. Two null hypotheses were statistically tested, when the hypothesis μ0.9 = μ0.6 = μSU was rejected at a significance level of 5%:~H10: μ0.9 = μSU, H11: μ0.9 ≠ μSU H20: μ0.6 = μSU, H21: μ0.6 ≠ μSU where μ0.6, μ0.9 and μSU are population mean after 24-week treatment for 0.6 mg+SU, 0.9 mg+SU and SU mono, respectively."||1.30|0.21|0.0071
72359658|NCT00395746|144230896|SUPERIORITY_OR_OTHER||Least Squares Mean|1.18|||<|0.0001||95.0|0.63|1.73||To perform the pairwise comparisons simultaneously, a closed testing procedure was applied. When the hypothesis μ0.9 = μ0.6 = μSU was rejected, the 2 hypotheses of pairwise comparison were tested simultaneously both at significance level of 5%.|ANOVA|||"ANOVA model included treatment group and pre-trial SU as fixed effects and corresponding baseline value as a covariate. Two null hypotheses were statistically tested, when the hypothesis μ0.9 = μ0.6 = μSU was rejected at a significance level of 5%:~H10: μ0.9 = μSU, H11: μ0.9 ≠ μSU H20: μ0.6 = μSU, H21: μ0.6 ≠ μSU where μ0.6, μ0.9 and μSU are population mean after 24-week treatment for 0.6 mg+SU, 0.9 mg+SU and SU mono, respectively."||1.73|0.63|<0.0001
72359659|NCT00395746|144230897|SUPERIORITY_OR_OTHER||Least Squares Mean|1.04||||||95.0|0.42|1.66|||ANOVA|||95% confidence interval for the mean difference (each liraglutide - SU monotherapy) was calculated under an analysis of variance (ANOVA) model with treatment group and pre-trial SU as fixed effects and corresponding baseline value as a covariate, and no statistical testing was performed.||1.66|0.42|
72359660|NCT00395746|144230897|SUPERIORITY_OR_OTHER||Least Squares Mean|1.13||||||95.0|0.51|1.75|||ANOVA|||95% confidence interval for the mean difference (each liraglutide - SU monotherapy) was calculated under an analysis of variance (ANOVA) model with treatment group and pre-trial SU as fixed effects and corresponding baseline value as a covariate, and no statistical testing was performed||1.75|0.51|
72359661|NCT00395746|144230898|SUPERIORITY_OR_OTHER||Rate ratio|1.59||||||95.0|0.86|2.96|||Negative binomial regression|||The relative risk for 'All hypoglycaemic episodes' and 95% confidence interval are based on a generalised linear negative-binomial model, which included treatment group as a fixed effect and log of exposure time as an offset variable.||2.96|0.86|
72359662|NCT00395746|144230898|SUPERIORITY_OR_OTHER||Rate ratio|1.18||||||95.0|0.56|2.47|||Negative binomial regression model|||The relative risk for 'Minor episodes' and 95% confidence interval are based on a generalised linear negative-binomial model, which included treatment group as a fixed effect and log of exposure time as an offset variable.||2.47|0.56|
72359663|NCT00395746|144230898|SUPERIORITY_OR_OTHER||Rate ratio|1.8||||||95.0|0.92|3.54|||Negative binomial regression model|||The relative risk for 'Symptoms only' and 95% confidence interval are based on a generalised linear negative-binomial model, which included treatment group as a fixed effect and log of exposure time as an offset variable.||3.54|0.92|
72359664|NCT00395746|144230898|SUPERIORITY_OR_OTHER||Rate ratio|1.62||||||95.0|0.85|3.07|||Negative binomial regression model|||The relative risk for 'All hypoglycaemic episodes' and 95% confidence interval are based on a generalised linear negative-binomial model, which included treatment group as a fixed effect and log of exposure time as an offset variable.||3.07|0.85|
72359665|NCT00395746|144230898|SUPERIORITY_OR_OTHER||Rate ratio|1.48||||||95.0|0.69|3.17|||Negative binomial regression model|||The relative risk for 'Minor episodes' and 95% confidence interval are based on a generalised linear negative-binomial model, which included treatment group as a fixed effect and log of exposure time as an offset variable.||3.17|0.69|
72359666|NCT00395746|144230898|SUPERIORITY_OR_OTHER||Rate ratio|1.45||||||95.0|0.72|2.91|||Negative binomial regression model|||The relative risk for 'Symptoms only episodes' and 95% confidence interval are based on a generalised linear negative-binomial model, which included treatment group as a fixed effect and log of exposure time as an offset variable.||2.91|0.72|
72359667|NCT03137992|144230903|EQUIVALENCE|Bioequivalence was declared if the 90% CI was entirely contained within the bioequivalence interval, 0.80 to 1.25.|Least Squared Mean Ratio|0.9369|||||TWO_SIDED|90.0|0.834|1.047|||||Fieller's formula was applied to calculate the 90% confidence interval (CI) for the Lupin Tiotropium and Spiriva Handihaler LS mean ratio.|A blinded interim analysis was performed after 241 subjects had been randomized with measurable AUC data, which estimated 238 patients would be needed to demonstrate BE with 90% power. Therefore, it was planned that approximately 378 patients would be randomized to allow for a potential 30% loss/withdrawal from the PP population.||1.047|0.834|
72359668|NCT03137992|144230904|SUPERIORITY||Least Squared Mean Difference|3.29|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|95.0|2.9386|3.646||Efficacy of the Test (T) product was demonstrated if the T was shown to be statistically superior to Placebo (p\<0.05 \[two-tailed\]).Outcome variable was Difference in Baseline adjusted FEV1 AUC0-24h.|Mixed Models Analysis|Mixed model repeated measures analysis consisted of effects of treatment, period, and sequence.||||3.646|2.9386|<0.001
72359669|NCT03137992|144230904|SUPERIORITY||Least Squared Mean Difference|3.43|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|95.0|3.0718|3.7797||Study sensitivity was demonstrated if the Reference (R) product was shown to be statistically superior to Placebo (P) (p \<0.05 \[two-tailed\]). Outcome variable was Difference in Baseline adjusted FEV1 AUC0-24h.|Mixed Models Analysis|Mixed model repeated measures analysis consisted of effects of treatment, period, and sequence.||||3.7797|3.0718|<0.001
72359670|NCT00795704|144230919|SUPERIORITY_OR_OTHER|||||||0.079|||||||t-test, 2 sided|||||||0.079
72359671|NCT00795704|144230921|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
72359672|NCT03980730|144230922|SUPERIORITY|||||||0.2057|||||||Mixed Models Analysis|||||||0.2057
72359673|NCT02392806|144230933|SUPERIORITY||||||>|0.05|||||||t-test, 2 sided|||||||>0.05
72359674|NCT03125226|144230937|OTHER|Single group mean and standard deviation||||||||||||||||Coordinates in x/y/z planes were assigned to each hydrogel marker on the planning CT and daily CBCT to calculate interfraction motion.|Single group mean and standard deviation|||
72359675|NCT03125226|144230942|OTHER|The Van Herk (VH) margin equation for the planning target volume margin, as a function of systemic and random errors, was calculated such that the CTV receives at least 95%-prescription dose in 90% of patients.|||||||||||||||||The Van Herk (VH) margin equation for the planning target volume margin, as a function of systemic and random errors, was calculated such that the CTV receives at least 95%-prescription dose in 90% of patients.|||
72359676|NCT00301808|144230943|SUPERIORITY_OR_OTHER_LEGACY||Kaplan-Meier product limit|0.66|STANDARD_ERROR_OF_MEAN|0.1423|||TWO_SIDED|95.0|0.48|0.84||||||||0.84|0.48|
72359677|NCT05893862|144230955|OTHER|LS Mean Difference 1 Hr|LS Mean Difference|9.22|||<|0.0001|TWO_SIDED|90.0|7.4|11.04|||t-test, 1 sided|||||11.04|7.40|<0.0001
72359678|NCT05893862|144230955|OTHER|LS Mean Difference 2 Hr|LS Mean Difference|8.44||||0.0141|TWO_SIDED|90.0|6.31|10.56|||t-test, 1 sided|||||10.56|6.31|0.0141
72359679|NCT05893862|144230955|OTHER|LS Mean Difference 3 Hr|LS Mean Difference|10.8|||<|0.0001|TWO_SIDED|90.0|8.85|12.74|||t-test, 1 sided|||||12.74|8.85|<0.0001
72359680|NCT05893862|144230955|OTHER|LS Mean Difference Week 4 Hr|LS Mean Difference|6.43||||0.1045|TWO_SIDED|90.0|3.96|8.91|||t-test, 1 sided|||||8.91|3.96|0.1045
72359681|NCT05893862|144230955|OTHER|LS Mean Difference 8 Hr|LS Mean Difference|6.52|||||TWO_SIDED|90.0|4.66|8.38||||||||8.38|4.66|
72359682|NCT05893862|144230955|OTHER|LS Mean Difference 11 Hr|LS Mean Difference|7.33||||||90.0|4.74|9.93||||||||9.93|4.74|
72359683|NCT05893862|144230955|OTHER|LS Mean Difference 14 Hr|LS Mean Difference|6.42|||||TWO_SIDED|90.0|3.95|8.88||||||||8.88|3.95|
72359684|NCT05893862|144230955|OTHER|LS Mean Difference 24 Hr|LS Mean Difference|2.79|||||TWO_SIDED|90.0|0.81|4.76||||||||4.76|0.81|
72359685|NCT05893862|144230958|OTHER|LS Mean Difference 0.5 Hr|LS Mean Difference|0.52|||||TWO_SIDED|90.0|-1.11|2.14||||||||2.14|-1.11|
72359686|NCT05893862|144230958|OTHER|LS Mean Difference 1 Hr|LS Mean Difference|0.36|||||TWO_SIDED|90.0|-1.26|1.98||||||||1.98|-1.26|
72359687|NCT05893862|144230958|OTHER|LS Mean Difference 2 Hr|LS Mean Difference|1.31|||||TWO_SIDED|90.0|-1.04|3.66||||||||3.66|-1.04|
72359688|NCT05893862|144230958|OTHER|LS Mean Difference 3 hr|LS Mean Difference|4.27|||||TWO_SIDED|90.0|1.9|6.64||||||||6.64|1.90|
72359689|NCT05893862|144230958|OTHER|LS Mean Difference 4 Hr|LS Mean Difference|7.0|||||TWO_SIDED|90.0|4.35|9.64||||||||9.64|4.35|
72359690|NCT05893862|144230958|OTHER|LS Mean Difference 6 Hr|LS Mean Difference|7.85|||||TWO_SIDED|90.0|4.35|9.64||||||||9.64|4.35|
72359691|NCT05893862|144230958|OTHER|LS Mean Difference 8 Hr|LS Mean Difference|9.25|||||TWO_SIDED|90.0|6.71|11.8||||||||11.80|6.71|
72359692|NCT05893862|144230958|OTHER|LS Mean Difference 12 Hr|LS Mean Difference|4.81|||||TWO_SIDED|90.0|2.27|7.35||||||||7.35|2.27|
72359693|NCT05893862|144230958|OTHER|LS Mean Difference 14 Hr|LS Mean Difference|3.57|||||TWO_SIDED|90.0|0.91|6.23||||||||6.23|0.91|
72359694|NCT05893862|144230958|OTHER|LS Mean Difference 24 Hr|LS Mean Difference|5.01|||||TWO_SIDED|90.0|3.18|6.85||||||||6.85|3.18|
72359695|NCT05893862|144230958|OTHER|LS Mean Difference 1 Hr|LS Mean Difference|3.95|||||TWO_SIDED|90.0|1.56|6.34||||||||6.34|1.56|
72359696|NCT05893862|144230958|OTHER|LS Mean Difference 2 Hr|LS Mean Difference|3.92|||||TWO_SIDED|90.0|1.49|6.35||||||||6.35|1.49|
72359697|NCT05893862|144230958|OTHER|LS Mean Difference 3 Hr|LS Mean Difference|4.68|||||TWO_SIDED|90.0|2.33|7.03||||||||7.03|2.33|
72359698|NCT05893862|144230958|OTHER|LS Mean Difference 4 Hr|LS Mean Difference|4.79|||||TWO_SIDED|90.0|2.45|7.12||||||||7.12|2.45|
72359699|NCT05893862|144230958|OTHER|LS Mean Difference 8 Hr|LS Mean Difference|4.82|||||TWO_SIDED|90.0|1.93|7.71||||||||7.71|1.93|
72359700|NCT05893862|144230958|OTHER|LS Mean Difference 11 Hr|LS Mean Difference|5.3|||||TWO_SIDED|90.0|2.51|8.09||||||||8.09|2.51|
72359701|NCT05893862|144230958|OTHER|LS Mean Difference 14 Hr|LS Mean Difference|5.85|||||TWO_SIDED|90.0|2.97|8.74||||||||8.74|2.97|
72359702|NCT05893862|144230958|OTHER|LS Mean Difference 16 Hr|LS Mean Difference|4.12|||||TWO_SIDED|90.0|1.79|6.45||||||||6.45|1.79|
72359703|NCT05893862|144230958|OTHER|LS Mean Difference 24 Hr|LS Mean Difference|0.78|||||TWO_SIDED|90.0|-1.69|3.26||||||||3.26|-1.69|
72359704|NCT05482308|144230974|OTHER||Mean differences(Test-Reference)|98.35|||||TWO_SIDED|90.0|92.92|104.1|||Mixed effect model|"Mixed effect model was fitted to obtain:~1.Adjusted mean differences 2.90% Confidence intervals(CI)"||||104.10|92.92|
72359705|NCT05482308|144230975|OTHER||Mean difference (Test-Reference)|91.58|||||TWO_SIDED|90.0|81.5|102.9|||Mixed effect model|"Mixed effect model was fitted to obtain:~1.Adjusted mean differences 2.90% Confidence intervals(CI)"||||102.90|81.50|
72359706|NCT04233008|144230978|SUPERIORITY|||||||0.04|||||||Wilcoxon (Mann-Whitney)|||||||0.04
72359707|NCT04233008|144230979|SUPERIORITY|||||||0.14|||||||Chi-squared|||||||0.14
72359708|NCT04233008|144230980|SUPERIORITY||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||||||<0.01
72359709|NCT04233008|144230981|SUPERIORITY|||||||0.39|||||||Chi-squared|||||||0.39
72359710|NCT04233008|144230982|SUPERIORITY||||||<|0.01|||||||Chi-squared|||||||<0.01
72359711|NCT04233008|144230984|SUPERIORITY|||||||0.8|||||||Chi-squared|||||||0.8
72359712|NCT00416624|144230990|NON_INFERIORITY_OR_EQUIVALENCE|If the hematopoietic response rate in the standard therapy group is far from 50% (\<25% or \>75%), the\> above sample size will provide an 80% power to detect a difference as small as\> 25%.|||||>|0.41|TWO_SIDED||||||Fisher Exact|||With 80 patients per treatment arm, there will be\> about 80% power to detect a difference through Fisher's exact test across two\> treatment arms of 25% in the true percentage of patients that experience a\> hematopoietic response as defined previously, if that percentage is at least 30% in\> the superior group, again with a 1.7% type I error rate.||||>0.41
72359713|NCT00416624|144230992|NON_INFERIORITY_OR_EQUIVALENCE|A sample size of 80 patients per arm will provide\> 80% power to detect differences between average hemoglobin levels in the\> reference arm and another treatment of 50% of the standard deviation. Note that\> typically one would expect the estimates for the standard deviation at a single time\> point to differ from the standard deviation for the difference from baseline.|||||>|0.13|TWO_SIDED||||||Fisher Exact|||||||>0.13
72359714|NCT00416624|144230994|NON_INFERIORITY_OR_EQUIVALENCE|If the hematopoietic response rate in the standard therapy group is far from 50% (\<25% or \>75%), the\> above sample size will provide an 80% power to detect a difference as small as\> 25%.|||||>|0.49|TWO_SIDED||||||Fisher Exact|||With 80 patients per treatment arm, there will be\> about 80% power to detect a difference through Fisher's exact test across two\> treatment arms of 25% in the true percentage of patients that experience a\> hematopoietic response as defined previously, if that percentage is at least 30% in\> the superior group, again with a 1.7% type I error rate.||||>0.49
72359715|NCT00416624|144230997|NON_INFERIORITY_OR_EQUIVALENCE|If the hematopoietic response rate in the standard therapy group is far from 50% (\<25% or \>75%), the above sample size will provide an 80% power to detect a difference as small as 25%.|||||>|0.56|TWO_SIDED||||||Fisher Exact|||With 80 patients per treatment arm, there will be about 80% power to detect a difference through Fisher's exact test across two treatment arms of 25% in the true percentage of patients that experience a hematopoietic response as defined previously, if that percentage is at least 30% in the superior group, again with a 1.7% type I error rate.||||>0.56
72359716|NCT03585660|144231032|SUPERIORITY|||||||0.02|||||||bootstrap z-test|The standard error of the difference in accuracy was estimated using nonparametric bootstrap, with B=9999 resamples.||The null hypothesis is that the accuracy of HM-MRI and mp-MRI are the same and the alternative hypothesis is that the accuracy of HM-MRI is greater than the accuracy of mp-MRI.||||0.02
72359717|NCT03585660|144231033|SUPERIORITY|||||||0.08|||||||bootstrap z-test|The standard error of the difference of AUCs was estimated using nonparametric bootstrap, with B=9999 resamples.||The null hypothesis is that the AUCs of HM-MRI and mp-MRI are the same and the alternative hypothesis is that the AUC of HM-MRI is greater than the AUC of mp-MRI.||||0.08
72359718|NCT03585660|144231034|SUPERIORITY|||||||0.97|||||||bootstrap z-test|||The null hypothesis is that the sensitivity of HM-MRI and mp-MRI are the same and the alternative hypothesis is that the sensitivity of HM-MRI is greater than the sensitivity of mp-MRI.||||0.97
72359719|NCT03585660|144231035|SUPERIORITY||||||<|0.01|||||||bootstrap z-test|||The null hypothesis is that the specificity of HM-MRI and mp-MRI are the same and the alternative hypothesis is that the specificity of HM-MRI is greater than the specificity of mp-MRI.||||<0.01
72359720|NCT03585660|144231036|SUPERIORITY|The null hypothesis is that the PPV of HM-MRI and mp-MRI are the same and the alternative hypothesis is that the PPV of HM-MRI is greater than the PPV of mp-MRI.||||||0.06|||||||bootstrap z-test|||||||0.06
72359721|NCT03585660|144231037|SUPERIORITY|The null hypothesis is that the NPV of HM-MRI and mp-MRI are the same and the alternative hypothesis is that the NPV of HM-MRI is greater than the NPV of mp-MRI.||||||0.97|||||||bootstrap z-test|||||||0.97
72359722|NCT00435409|144231038|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.2239||||0.9409|TWO_SIDED|95.0|0.9487|1.5789||Stratification factors included metastatic organ sites (2 or less versus \[vs\] more than \[\>\] 2 sites), hormone receptor status (HER2-/ER-/PR-) vs all others), and prior chemotherapy regimens (1 vs \>1), from interactive voice response system (IVRS).|Log Rank|||A stratified log-rank test (1-sided, α=0.025) based on randomization stratification factors||1.5789|0.9487|0.9409
72359723|NCT00435409|144231038|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.1084||||0.812|TWO_SIDED|95.0|0.8817|1.3935||Stratification factors include metastatic organ sites (2 or less versus \[vs\] 2 or more sites), hormone receptor status (HER2-/ER-/PR-) vs all others), and prior chemotherapy regimens (1 vs more than 1), from IVRS.|Log Rank|||A stratified log-rank test (1-sided, α=0.025) based on randomization stratification factors||1.3935|0.8817|0.8120
72359724|NCT00435409|144231039|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.17||||0.3143|TWO_SIDED|95.0|0.69|1.97||A stratified CMH test stratified by randomization stratification factors was used to compare objective response rate (ORR) between two treatment arms.|Cochran-Mantel-Haenszel|||Independent radiology assessment||1.97|0.69|0.3143
72359725|NCT00435409|144231039|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.32||||0.1269|TWO_SIDED|95.0|0.83|2.13||A stratified CMH test stratified by randomization stratification factors was used to compare ORR between two treatment arms.|Cochran-Mantel-Haenszel|||Investigator's assessment||2.13|0.83|0.1269
72359726|NCT00435409|144231041|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.0372||||0.6275|TWO_SIDED|95.0|0.8322|1.2927||Stratification factors (all from IVRS) included number of metastatic organ sites (\<=2 vs \>2 sites), hormone receptor status (HER2-/ER-/PR- vs all others), and prior chemotherapy regimens (1 vs \>1).|Log Rank||Hazard ratio for sunitinib + capecitabine versus capecitabine.|||1.2927|0.8322|0.6275
72359727|NCT05635461|144231047|OTHER||Geometric Mean Ratio|60.13|||||TWO_SIDED|90.0|56.12|64.42|||||Geometric mean ratio was obtained by multiplying 100 with ratio of test (CVN424 tablet fasted) and reference (CVN424 suspension fasted).|||64.42|56.12|
72359728|NCT05635461|144231048|OTHER||Geometric Mean Ratio|60.12|||||TWO_SIDED|90.0|56.12|64.42|||||Geometric mean ratio was obtained by multiplying 100 with ratio of test (CVN424 tablet fasted) and reference (CVN424 suspension fasted).|||64.42|56.12|
72359729|NCT05635461|144231049|OTHER||Geometric Mean Ratio|27.94|||||TWO_SIDED|90.0|25.09|31.13|||||Geometric mean ratio was obtained by multiplying 100 with ratio of test (CVN424 tablet fasted) and reference (CVN424 suspension fasted).|||31.13|25.09|
72359730|NCT05635461|144231050|OTHER||Median Difference (Final Values)|1.04|||<|0.0001|TWO_SIDED|90.0|0.9265|2.247|||ANOVA|||||2.2470|0.9265|<0.0001
72359731|NCT05635461|144231050|OTHER||Median Difference (Final Values)|2.78|||<|0.0001|TWO_SIDED|90.0|2.4475|3.0035|||ANOVA|||||3.0035|2.4475|<0.0001
72359732|NCT05635461|144231051|OTHER||Median Difference (Final Values)|0.0|||||TWO_SIDED|90.0|0.0|0.0||||||||0.000|0.000|
72359733|NCT05635461|144231051|OTHER||Median Difference (Final Values)|0.25||||0.001|TWO_SIDED|90.0|0.0|0.251|||ANOVA|||||0.2510|0.0000|0.0010
72359734|NCT05635461|144231052|OTHER||Geometric Mean Ratio|161.57|||||TWO_SIDED|90.0|150.96|172.92|||||Geometric mean ratio was obtained by multiplying 100 with ratio of test (CVN424 tablet Fed) and reference (CVN424 tablet fasted).|||172.92|150.96|
72359735|NCT05635461|144231053|OTHER||Geometric Mean Ratio|161.59|||||TWO_SIDED|90.0|150.98|172.95|||||Geometric mean ratio was obtained by multiplying 100 with ratio of test (CVN424 tablet Fed) and reference (CVN424 tablet fasted).|||172.95|150.98|
72359736|NCT05635461|144231054|OTHER||Geometric Mean Ratio|304.19|||||TWO_SIDED|90.0|273.51|338.31|||||Geometric mean ratio was obtained by multiplying 100 with ratio of test (CVN424 tablet Fed) and reference (CVN424 tablet fasted).|||338.31|273.51|
72359737|NCT05635461|144231055|OTHER||Median Difference (Final Values)|0.99||||0.0662|TWO_SIDED|90.0|0.006|1.537|||ANOVA|||||1.5370|0.0060|0.0662
72359738|NCT05635461|144231056|OTHER||Median Difference (Final Values)|0.25||||0.0039|TWO_SIDED|90.0|0.0|0.251|||ANOVA|||||0.2510|0.0000|0.0039
72359739|NCT03137654|144231174|SUPERIORITY|||||||0.0078|||||||Linear Mixed Model|||||||.0078
72359740|NCT03137654|144231178|SUPERIORITY|||||||0.393|||||||ANOVA|||||||0.393
72359741|NCT03137654|144231180|SUPERIORITY|||||||0.0344|||||||ANOVA|||||||.0344
72359742|NCT03137654|144231181|SUPERIORITY|||||||0.0344|||||||ANOVA|||||||.0344
72359743|NCT03137654|144231182|SUPERIORITY|||||||0.0365|||||||ANOVA|||||||0.0365
72359744|NCT03137654|144231183|SUPERIORITY|||||||0.212|||||||ANOVA|||||||.212
72359745|NCT03137654|144231184|SUPERIORITY||||||<|0.001|||||||ANOVA|||||||<.001
72359746|NCT03137654|144231185|SUPERIORITY|||||||0.445|||||||ANOVA|||||||.445
72359747|NCT03137654|144231186|SUPERIORITY|||||||0.245|||||||ANOVA|||||||.245
72359748|NCT04890652|144231187|OTHER|single group. The power-related information was estimated by calculating the effect size, specifically partial eta squared.|||||<|0.001|||||||General Linear Model|||||||<0.001
72359749|NCT04890652|144231188|OTHER|Single group. The power-related information was estimated by calculating the effect size, specifically partial eta squared.|||||<|0.001|||||||General Linear Model|||||||<0.001
72359750|NCT00883779|144231246|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.57|||<|0.0001|TWO_SIDED|95.0|0.46|0.7|||Log Rank|||||0.70|0.46|<0.0001
72359751|NCT00883779|144231248|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.5|||<|0.0001|TWO_SIDED|95.0|0.39|0.64|||Log Rank|||PFS in adenocarcinoma subgroup||0.64|0.39|<0.0001
72359752|NCT00883779|144231248|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.9|||=|0.579|TWO_SIDED|95.0|0.6|1.33|||Log Rank|||PFS in non-adenocarcinoma subgroup||1.33|0.60|=0.579
72359753|NCT00883779|144231248|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.39|||<|0.0001|TWO_SIDED|95.0|0.28|0.53|||Log Rank|||PFS in never smoked subgroup||0.53|0.28|<0.0001
72359754|NCT00883779|144231248|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.84|||=|0.2067|TWO_SIDED|95.0|0.64|1.1|||Log Rank|||PFS in former/current smoker subgroup||1.10|0.64|=0.2067
72359755|NCT00883779|144231248|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.21|||<|0.0001|TWO_SIDED|95.0|0.12|0.35|||Log Rank|||PFS in subgroup EGFR mutation||0.35|0.12|<0.0001
72359756|NCT00883779|144231248|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.95|||=|0.7511|TWO_SIDED|95.0|0.67|1.34|||Log Rank|||PFS in subgroup EGFR wild-type||1.34|0.67|=0.7511
72359757|NCT00883779|144231248|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.63|||=|0.3169|TWO_SIDED|95.0|0.25|1.58|||Log Rank|||PFS in subgroup KRAS mutation||1.58|0.25|=0.3169
72359758|NCT00883779|144231248|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.51|||<|0.0001|TWO_SIDED|95.0|0.37|0.7|||Log Rank|||PFS in subgroup KRAS wild-type||0.70|0.37|<0.0001
72359759|NCT00883779|144231248|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.51|||=|0.0091|TWO_SIDED|95.0|0.31|0.86|||Log Rank|||PFS in subgroup EGFR IHC positive||0.86|0.31|=0.0091
72359760|NCT00883779|144231248|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.4|||=|0.0179|TWO_SIDED|95.0|0.18|0.88|||Log Rank|||PFS in subgroup EGFR IHC negative||0.88|0.18|=0.0179
72359761|NCT00883779|144231248|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.26|||=|0.0017|TWO_SIDED|95.0|0.11|0.64|||Log Rank|||PFS in subgroup EGFR FISH positive||0.64|0.11|=0.0017
72359762|NCT00883779|144231248|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.67|||=|0.188|TWO_SIDED|95.0|0.37|1.22|||Log Rank|||PFS in subgroup EGFR FISH negative||1.22|0.37|=0.1880
72359763|NCT00883779|144231249|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.85|||=|0.1213|TWO_SIDED|95.0|0.7|1.04|||Log Rank|||OS in overall participants (FAS population)||1.04|0.70|=0.1213
72359764|NCT00883779|144231249|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.78|||=|0.0356|TWO_SIDED|95.0|0.62|0.98|||Log Rank|||OS in subgroup adenocarcinoma||0.98|0.62|=0.0356
72359765|NCT00883779|144231249|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.37|||=|0.1157|TWO_SIDED|95.0|0.92|2.03|||Log Rank|||OS in subgroup non-adenocarcinoma||2.03|0.92|=0.1157
72359766|NCT00883779|144231249|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.66|||=|0.0056|TWO_SIDED|95.0|0.49|0.89|||Log Rank|||OS in subgroup never smoked||0.89|0.49|=0.0056
72359767|NCT00883779|144231249|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.14|||=|0.3473|TWO_SIDED|95.0|0.87|1.5|||Log Rank|||OS in subgroup current/former smoker||1.50|0.87|=0.3473
72359768|NCT00883779|144231249|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.72|||=|0.1614|TWO_SIDED|95.0|0.45|1.14|||Log Rank|||OS in subgroup EGFR mutation||1.14|0.45|=0.1614
72359769|NCT00883779|144231249|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.78|||=|0.1691|TWO_SIDED|95.0|0.55|1.11|||Log Rank|||OS in subgroup EGFR wild-type||1.11|0.55|=0.1691
72359770|NCT00883779|144231249|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.5|||=|0.1415|TWO_SIDED|95.0|0.19|1.28|||Log Rank|||OS in subgroup KRAS mutation||1.28|0.19|=0.1415
72359771|NCT00883779|144231249|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.8|||=|0.1447|TWO_SIDED|95.0|0.59|1.08|||Log Rank|||OS in subgroup KRAS wild-type||1.08|0.59|=0.1447
72359772|NCT00883779|144231249|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.58|||=|0.031|TWO_SIDED|95.0|0.35|0.96|||Log Rank|||OS in EGFR IHC positive||0.96|0.35|=0.0310
72359773|NCT00883779|144231249|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.46|||=|0.0581|TWO_SIDED|95.0|0.21|1.05|||Log Rank|||OS in subgroup EGFR IHC negative||1.05|0.21|=0.0581
72359774|NCT00883779|144231249|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.32|||=|0.0063|TWO_SIDED|95.0|0.14|0.75|||Log Rank|||OS of subgroup EGFR FISH positive||0.75|0.14|=0.0063
72359775|NCT00883779|144231249|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.74|||=|0.3268|TWO_SIDED|95.0|0.4|1.36|||Log Rank|||OS of subgroup EGFR FISH negative||1.36|0.40|=0.3268
72359776|NCT00883779|144231251|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.81|||=|0.5289|TWO_SIDED|95.0|-6.2|11.8|||Chi-squared|||Difference in non-progression response rates||11.8|-6.2|=0.5289
72359777|NCT00883779|144231252|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|25.14|||<|0.0001|TWO_SIDED|95.0|16.7|33.5|||Chi-squared|||Difference in objective response rates||33.5|16.7|<0.0001
72359778|NCT00883779|144231253|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.32|||<|0.0001|TWO_SIDED|95.0|0.21|0.5|||Log Rank|||||0.50|0.21|<0.0001
72359779|NCT00883779|144231254|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.55|||<|0.0001|TWO_SIDED|95.0|0.45|0.69|||Log Rank|||||0.69|0.45|<0.0001
72359780|NCT00883779|144231256|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.79|||=|0.0364|TWO_SIDED|95.0|0.63|0.99|||Log Rank|||||0.99|0.63|=0.0364
72359781|NCT00883779|144231258|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.77|||=|0.0181|TWO_SIDED|95.0|0.61|0.96|||Log Rank|||||0.96|0.61|=0.0181
72359782|NCT00883779|144231260|SUPERIORITY_OR_OTHER||Hazard Ratio, log|0.73|||=|0.0035|TWO_SIDED|95.0|0.59|0.9|||Log Rank|||||0.90|0.59|=0.0035
72359783|NCT00883779|144231261|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.97||||0.913|TWO_SIDED|95.0|0.6|1.59|||Log Rank|||||1.59|0.60|0.9130
72359784|NCT00659061|144231263|SUPERIORITY_OR_OTHER|||||||0.32||95.0||||at baseline|Chi-squared|||||||0.32
72359785|NCT00659061|144231263|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||at endline|Chi-squared|||||||<0.001
72359786|NCT00659061|144231265|SUPERIORITY_OR_OTHER||||||<|0||95.0|||||ANOVA|adjusted for baseline, child age, sex, number of sprinkles sachets consumed, number of mths between enrollment and endline Hb measurement)||||||<0.000
72359787|NCT00659061|144231266|SUPERIORITY_OR_OTHER|||||||0.34||95.0||||baseline|Chi-squared|||||||0.34
72359788|NCT00659061|144231266|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||endline|Chi-squared|||||||<0.001
72359789|NCT00659061|144231267|SUPERIORITY_OR_OTHER|||||||0||95.0||||endline|ANOVA|adjusted for baseline child age, sex, # of sprinkle sachet consumed, # of mths between enrollment and endline Hb measurement||||||0.000
72359790|NCT00659061|144231268|SUPERIORITY_OR_OTHER|||||||0.7||95.0||||baseline|Chi-squared|||||||0.7
72359791|NCT00659061|144231268|SUPERIORITY_OR_OTHER|||||||0.02||95.0||||endline|Chi-squared|||||||0.02
72359792|NCT00659061|144231269|SUPERIORITY_OR_OTHER|||||||0.62||95.0||||baseline|Chi-squared|||||||0.62
72359793|NCT00659061|144231269|SUPERIORITY_OR_OTHER|||||||0.89||95.0||||endline|Chi-squared|||||||0.89
72359794|NCT00659061|144231270|SUPERIORITY_OR_OTHER|||||||0.93||95.0||||baseline|Chi-squared|||||||0.93
72359795|NCT00659061|144231270|SUPERIORITY_OR_OTHER|||||||0.49||95.0||||endline|Chi-squared|||||||0.49
72359796|NCT00079040|144231273|SUPERIORITY_OR_OTHER||Percentage|63.5|||||TWO_SIDED|90.0|52.4|73.6||||||||73.6|52.4|
72359797|NCT03748823|144231294|NON_INFERIORITY|Noninferiority was determined based on the 90% Confidence interval calculated from the combination z-score that accounts for the interim analysis.|Ratio of Geometric Least Squares Mean|1.257|||<|0.0001|TWO_SIDED|90.0|1.16|1.361||Analysis of variance (ANOVA) was performed on log-transformed Ctrough and included treatment and stratified weight group as fixed effects.|ANOVA||Geometric least squares mean are the least squares mean from the mixed model after back transformation to the original scale. The 90% confidence interval is presented after back transformation to the original scale.|||1.361|1.160|<0.0001
72359798|NCT00591006|144231384|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||Mixed Models Analysis|||||||<0.01
72359799|NCT00591006|144231384|SUPERIORITY_OR_OTHER|||||||0.12|TWO_SIDED||||||Mixed Models Analysis|||||||.12
72359800|NCT00591006|144231384|SUPERIORITY_OR_OTHER|||||||0.15|TWO_SIDED||||||Mixed Models Analysis|||||||.15
72359801|NCT00591006|144231384|SUPERIORITY_OR_OTHER|||||||0.1|TWO_SIDED||||||Mixed Models Analysis|||||||.10
72359802|NCT00591006|144231385|SUPERIORITY_OR_OTHER|||||||0.08|TWO_SIDED||||||Mixed Models Analysis|||||||.08
72359803|NCT00591006|144231385|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||Mixed Models Analysis|||||||<.01
72359804|NCT00591006|144231385|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||Mixed Models Analysis|||||||<.01
72359805|NCT00591006|144231385|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED||||||Mixed Models Analysis|||||||.02
72359806|NCT00591006|144231386|SUPERIORITY_OR_OTHER|||||||0.08|TWO_SIDED||||||Mixed Models Analysis|||||||.08
72359807|NCT00591006|144231386|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||Mixed Models Analysis|||||||<.01
72359808|NCT00591006|144231386|SUPERIORITY_OR_OTHER|||||||0.11|TWO_SIDED||||||Mixed Models Analysis|||||||.11
72359809|NCT00591006|144231386|SUPERIORITY_OR_OTHER|||||||0.06|TWO_SIDED||||||Mixed Models Analysis|||||||.06
72359810|NCT03174184|144231399|EQUIVALENCE|Equivalence tests will be conducted to examine whether the EBA0-14CFU of Arm A is different from the EBA0-14CFU of Arm B. A similar comparison will be done comparing Arm C to Arm D, Arm A to Arm C, Arm D to Arm E, Arm D to Arm F, and Arm E to Arm F.|||||<|0.001|||||||Regression, Linear|||||||<0.001
72359811|NCT02588599|144231416|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|t=8.0; df=53||||||<0.0001
72359812|NCT03346434|144231426|SUPERIORITY||Percentage difference|23.8|||<|0.0001|TWO_SIDED|95.0|13.27|34.37||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||||34.37|13.27|< 0.0001
72359813|NCT03346434|144231427|SUPERIORITY||Percentage difference|42.3|||<|0.0001|TWO_SIDED|95.0|29.47|55.16||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||||55.16|29.47|< 0.0001
72359814|NCT03346434|144231436|SUPERIORITY||Least Square (LS) Mean Difference|-50.4|||<|0.0001|TWO_SIDED|95.0|-62.38|-38.4||Threshold for significance at 0.05 level.|ANCOVA|||||-38.40|-62.38|< 0.0001
72359815|NCT03346434|144231437|SUPERIORITY||LS Mean Difference|-47.1|||<|0.0001|TWO_SIDED|95.0|-59.47|-34.79||Threshold for significance at 0.05 level.|ANCOVA|||||-34.79|-59.47|< 0.0001
72359816|NCT03346434|144231438|SUPERIORITY||Percentage difference|39.2|||<|0.0001|TWO_SIDED|95.0|26.18|52.27||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||||52.27|26.18|< 0.0001
72359817|NCT03346434|144231439|SUPERIORITY||Percentage difference|43.3|||<|0.0001|TWO_SIDED|95.0|30.03|56.67||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||||56.67|30.03|< 0.0001
72359818|NCT03346434|144231440|SUPERIORITY||Percentage difference|48.5|||<|0.0001|TWO_SIDED|95.0|35.03|62.0||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||||62.00|35.03|< 0.0001
72359819|NCT03346434|144231441|SUPERIORITY||Percentage difference|22.5|||=|0.0001|TWO_SIDED|95.0|12.37|32.6||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||||32.60|12.37|= 0.0001
72359820|NCT03346434|144231442|SUPERIORITY||LS Mean Difference|-24.27|||<|0.0001|TWO_SIDED|95.0|-31.204|-17.329||Threshold for significance at 0.05 level.|ANCOVA|||||-17.329|-31.204|< 0.0001
72359821|NCT03346434|144231443|SUPERIORITY||LS Mean Difference|-9.1|||<|0.0001|TWO_SIDED|95.0|-11.26|-6.89||Threshold for significance at 0.05 level.|ANCOVA|||||-6.89|-11.26|< 0.0001
72359822|NCT03346434|144231444|SUPERIORITY||LS Mean Difference|-38.4|||<|0.0001|TWO_SIDED|95.0|-46.65|-30.21||Threshold for significance at 0.05 level.|ANCOVA|||||-30.21|-46.65|< 0.0001
72359823|NCT03346434|144231445|SUPERIORITY||LS Mean Difference|1.7|||<|0.0001|TWO_SIDED|95.0|1.093|2.317||Threshold significance was at 0.05 level.|ANCOVA|||||2.317|1.093|< 0.0001
72359824|NCT03346434|144231446|SUPERIORITY||LS Mean Difference|-3.31|||<|0.0001|TWO_SIDED|95.0|-4.029|-2.6||Threshold significance at 0.05 level.|ANCOVA|||||-2.600|-4.029|< 0.0001
72359825|NCT03346434|144231447|SUPERIORITY||LS Mean Difference|-7.8|||<|0.0001|TWO_SIDED|95.0|-9.789|-5.814||Threshold significance at 0.05 level.|ANCOVA|||||-5.814|-9.789|< 0.0001
72359826|NCT03346434|144231448|SUPERIORITY||LS Mean Difference|-7.5|||<|0.0001|TWO_SIDED|95.0|-10.29|-4.75||Threshold significance at 0.05 level.|ANCOVA|||||-4.75|-10.29|< 0.0001
72359827|NCT03346434|144231449|SUPERIORITY||LS Mean Difference|-8.96|||<|0.0001|TWO_SIDED|95.0|-11.711|-6.202||Threshold significance at 0.05 level.|ANCOVA|||||-6.202|-11.711|< 0.0001
72359828|NCT03346434|144231450|SUPERIORITY||||||=|0.0015||||||Threshold significance is at 0.05 level.|ANCOVA|||||||= 0.0015
72359829|NCT03346434|144231451|SUPERIORITY||LS Mean Difference|-2.9|||=|0.0997|TWO_SIDED|95.0|-6.35|0.56||Threshold significance at 0.05 level.|ANCOVA|||||0.56|-6.35|= 0.0997
72359830|NCT03525444|144231454|SUPERIORITY||Least Squares (LS) Mean Difference|13.8|||<|0.0001|TWO_SIDED|95.0|12.1|15.4|||Mixed-effects model for repeated measure|||The data presented for Primary endpoint was based on interim analysis at Week 4.||15.4|12.1|<0.0001
72359831|NCT03525444|144231455|SUPERIORITY||LS Mean Difference|14.3|||<|0.0001|TWO_SIDED|95.0|12.7|15.8|||Mixed-effects model for repeated measure|||||15.8|12.7|<0.0001
72359832|NCT03525444|144231456|SUPERIORITY||Rate ratio|0.37|||<|0.0001|TWO_SIDED|95.0|0.25|0.55|||Negative binomial regression model|||||0.55|0.25|<0.0001
72359833|NCT03525444|144231457|SUPERIORITY||LS Mean Difference|-41.8|||<|0.0001|TWO_SIDED|95.0|-44.4|-39.3|||Mixed-effects model for repeated measure|||||-39.3|-44.4|<0.0001
72359834|NCT03525444|144231458|SUPERIORITY||LS Mean Difference|20.2|||<|0.0001|TWO_SIDED|95.0|17.5|23.0|||Mixed-effects model for repeated measure|||||23.0|17.5|<0.0001
72359835|NCT03525444|144231459|SUPERIORITY||LS Mean Difference|1.04|||<|0.0001|TWO_SIDED|95.0|0.85|1.23|||Mixed-effects model for repeated measure|||||1.23|0.85|<0.0001
72359836|NCT03525444|144231460|SUPERIORITY||LS Mean Difference|-41.2|||<|0.0001|TWO_SIDED|95.0|-44.0|-38.5|||Mixed-effects model for repeated measure|||||-38.5|-44.0|<0.0001
72359837|NCT03525444|144231461|SUPERIORITY||LS Mean Difference|20.1|||<|0.0001|TWO_SIDED|95.0|16.9|23.2|||Mixed-effects model for repeated measure|||||23.2|16.9|<0.0001
72359838|NCT03525444|144231463|SUPERIORITY||LS Mean Difference|0.3|||||TWO_SIDED|95.0|0.17|0.43||||||||0.43|0.17|
72359839|NCT03525444|144231464|SUPERIORITY||LS Mean Difference|2.9|||||TWO_SIDED|95.0|2.3|3.4||||||||3.4|2.3|
72359840|NCT01183689|144231467|SUPERIORITY||Mean Difference (Net)|0.82|STANDARD_ERROR_OF_MEAN|0.3|<|0.05|TWO_SIDED|95.0|0.23|1.41||No interim analyses were conducted. Pairwise differences among the three arms were assessed with a 2 degree of freedom Wald Test.|Mixed Models Analysis||Above is provided the mean difference between Arms 1 and 2.|Mean changes from random effects model applied to repeated measures to compute the average differences among groups over time.||1.41|0.23|<0.05
72359841|NCT01183689|144231467|SUPERIORITY||Mean Difference (Net)|2.64|||<|0.05|TWO_SIDED|95.0|2.05|3.22|||Mixed Models Analysis|This was fitted with Proc Mixed in SAS.|95% confidence interval excludes 0|Mean changes from a random effects model applied to repeated measures to compute the average differences between groups over time. This entry is for the comparison between groups 1 and 3.||3.22|2.05|<0.05
72359842|NCT01183689|144231468|OTHER|Generalized Estimating Equations|Odds Ratio (OR)|1.41|||<|0.05|TWO_SIDED|95.0|1.02|1.9|||Generalized Estimating Equations|||Generalized estimating equations were used to compare the average percent of weight gainers over time among the three groups. The null hypothesis was that there was no difference in these average percentages. Participants were assigned values of 0 or 1 at each visit depending on their weight gain status. The percentages were summarized with odds ratios for weight gain over time.||1.90|1.02|<0.05
72359843|NCT01183689|144231468|SUPERIORITY||Odds Ratio (OR)|2.28|||<|0.05|TWO_SIDED|95.0|1.64|3.19|||generalized estimating equations|||This is a parallel analysis, comparing groups 1 and 3, using generalized estimating equations to summarize the odds ratio for weight gain in group 1 versus group 3,||3.19|1.64|<0.05
72359844|NCT01183689|144231469|SUPERIORITY||Mean Difference (Net)|1.31|STANDARD_ERROR_OF_MEAN|0.47|<|0.05|TWO_SIDED|95.0|0.39|2.24|||Mixed Models Analysis|The p-value is based on a 2 degree of freedom Wald test within the mixed effect model to test for pairwise differences among the 3 arms.|Listed above is the mean difference between arms 1 and 2|Mean differences at 2 years are calculated from a linear contrast within a mixed effects model. Note that this comparison is between Groups 1 and 2.||2.24|0.39|<0.05
72359845|NCT01183689|144231469|SUPERIORITY||Median Difference (Net)|2.04|||<|0.05|TWO_SIDED|95.0|1.11|2.98|||Mixed Models Analysis|A linear contrast was used to compare groups 1 and 3 at 24 months.||A linear contrast from a mixed effects model was used to compare mean differences at 24 months between groups 1 and 3.||2.98|1.11|<0.05
72359846|NCT01183689|144231470|SUPERIORITY||Mean Difference (Net)|1.99||||0.13|TWO_SIDED|95.0|0.06|3.92||The p-value is from a 2 degree of freedom test for pairwise difference among the 3 arms within an analysis of variance.|ANOVA|||Analysis of variance to assess mean differences in changes from baseline in systolic blood pressure. This analysis compares groups 1 and 2.||3.92|0.06|0.13
72359847|NCT01183689|144231470|SUPERIORITY||Mean Difference (Net)|0.93||||0.13|TWO_SIDED|95.0|-0.98|2.84|||ANOVA|||Mean differences in systolic blood pressure between groups 1 and 3 over time.||2.84|-0.98|0.13
72359848|NCT01183689|144231471|SUPERIORITY||Mean Difference (Net)|1.73||||0.06|TWO_SIDED|95.0|0.32|3.14||The p-value is from a 2 degree of freedom F-test from an analysis of variance to compare mean differences among the 3 arms.|ANOVA|||Mean differences from baseline to 2 years were compared among the 3 arms using analysis of variance.||3.14|0.32|0.06
72359849|NCT01183689|144231471|SUPERIORITY||Mean Difference (Net)|0.92||||0.06|TWO_SIDED|95.0|-0.49|2.33||This p-value is from a 2 degree of freedom omnibus test for differences among the 3 groups.|ANOVA|||Analysis of variance was used to compare mean changes from baseline to 2 years in diastolic blood pressure.||2.33|-0.49|0.06
72359850|NCT01183689|144231472|SUPERIORITY||Mean Difference (Net)|-1.3||||0.73|TWO_SIDED|95.0|-6.12|3.52||The p-value results from a 2 degree of freedom F-test.|ANOVA|||Mean changes from baseline to 2 years were compared between Groups 1 and 2.||3.52|-6.12|0.73
72359851|NCT01183689|144231472|SUPERIORITY||Mean Difference (Net)|-1.89||||0.73|TWO_SIDED|95.0|-4.36|0.58||This p-value is from a 2 degree of freedom test for differences among the 3 groups.|ANOVA|||Analysis of variance was used to compare mean differences in total cholesterol changes from baseline among groups.||0.58|-4.36|0.73
72359852|NCT01183689|144231473|SUPERIORITY||Odds Ratio (OR)|2.36|||<|0.001|TWO_SIDED|95.0|1.23|4.52||The p-value is a 2 degree of freedom test from the generalized estimating equations analysis applied to the longitudinal binary data among the 3 study arms.|generalized estimating equations|||The average percentage of participants who were obese across follow-up were compared among the 3 arms using a generalized estimating equations approach for repeated binary measures. Participants were assigned values of 0 or 1 depending on their obesity status at each exam. Differences were summarized with odds ratios.||4.52|1.23|<0.001
72359853|NCT01183689|144231473|SUPERIORITY||Odds Ratio (OR)|2.13||||0.008|TWO_SIDED|95.0|1.12|4.1||This p-value is from a 2 degree of freedom test for differences among the 3 groups.|generalized estimating equations|||Generalized estimating equations were used. Differences were summarized with odds ratios.||4.10|1.12|0.008
72359854|NCT01183689|144231474|SUPERIORITY||Mean Difference (Net)|-0.08||||0.002|TWO_SIDED|95.0|-0.61|0.45||the p-value results from a 2 degree of freedom F-test to assess pairwise differences among the 3 groups|ANOVA|the p-value results from a 2 degree of freedom F-test to assess pairwise differences among the 3 groups||Mean changes from baseline to 2 years among the 3 groups were assessed using a 2 degree of freedom F-test||0.45|-0.61|0.002
72359855|NCT01183689|144231474|SUPERIORITY||Mean Difference (Net)|0.55||||0.002|TWO_SIDED|95.0|0.02|1.08||This p-value is from a 2 degree of freedom test for differences among all 3 groups|ANOVA|||Differences among the 3 groups were based on analyses of variance.||1.08|0.02|0.002
72359856|NCT01183689|144231475|SUPERIORITY|A 2 degree of freedom F-test from ANOVA was used to compare mean differences in changes among the 3 arms of the study.|Mean Difference (Net)|-0.85|||<|0.001|TWO_SIDED|95.0|-1.32|-0.38||The p-value is from a 2 degree of freedom F test to assess differences among the 3 arms of the study.|ANOVA|The p-value is from a 2 degree of freedom F test to assess differences among the 3 arms of the study.||Changes in units of the scale from baseline to 2 years||-0.38|-1.32|<0.001
72359857|NCT01183689|144231475|SUPERIORITY||Mean Difference (Net)|-0.1|||<|0.001|TWO_SIDED|95.0|-0.57|0.37||This p-value is from a 2 degree of freedom test to compare differences among the 3 groups.|ANOVA|||Analysis of variance was used to compare mean changes from baseline to 2 years among the 3 groups.||0.37|-0.57|<0.001
72359858|NCT01183689|144231476|SUPERIORITY|2 degree of freedom F-test from analysis of variance to compare 2 year differences from baseline among the 3 arms of the study|Mean Difference (Net)|0.2|||<|0.001|TWO_SIDED|95.0|-0.31|0.71||2 degree of freedom F-test from analysis of variance to compare 2 year differences from baseline among the 3 arms of the study, not adjusted for multiple comparisons among endpoints|ANOVA|2 degree of freedom F-test from analysis of variance to compare 2 year differences from baseline among the 3 arms of the study||2 degree of freedom F-test from analysis of variance to compare 2 year differences from baseline among the 3 arms of the study||0.71|-0.31|<0.001
72359859|NCT01183689|144231476|SUPERIORITY||Mean Difference (Net)|0.88||||0.002|TWO_SIDED|95.0|0.37|1.39||This p-value is from a 2 degree freedom test of differences among the 3 groups.|ANOVA|||Analysis of variance was used to compare mean changes from baseline to year 2 among the 3 groups.||1.39|0.37|0.002
72359860|NCT01183689|144231477|SUPERIORITY||Mean Difference (Net)|-0.13|||<|0.001|TWO_SIDED|95.0|-0.71|0.45||2 degree of freedom F-test from analysis of variance|ANOVA|2 degree of freedom F-test from analysis of variance to compare mean differences among arms||2 degree F-test from analysis of variance applied to 2 year changes in scores from baseline||0.45|-0.71|<0.001
72359861|NCT01183689|144231477|SUPERIORITY||Median Difference (Net)|1.4|||<|0.001|TWO_SIDED|95.0|0.82|1.98||This p-value is from the omnibus 2 degree of freedom test for mean differences among the 3 groups.|ANOVA|||Analysis of variance was used to compare mean changes from baseline to 2 years among the 3 groups.||1.98|0.82|<0.001
72359862|NCT01183689|144231478|SUPERIORITY||Mean Difference (Net)|-0.08||||0.24|TWO_SIDED|95.0|-0.24|0.09||This p-value is from a 2 degree of freedom test for differences among the 3 arms.|ANOVA|2 degree of freedom test from analysis of variance to assess mean differences among the 3 arms||2 degree of freedom F-test from analysis of variance to compare 2 year differences in general health index values among the 3 arms||0.09|-0.24|0.24
72359863|NCT01183689|144231478|SUPERIORITY||Mean Difference (Net)|-0.15||||0.24|TWO_SIDED|95.0|-0.32|0.02||This p-value is from the 2 degree of freedom test of differences among the 3 arms.|ANOVA|||Analysis of variance was used to compare differences in changes from baseline to 2 years among the three arms.||0.02|-0.32|0.24
72359864|NCT01183689|144231479|SUPERIORITY||Mean Difference (Net)|1.52||||0.16|TWO_SIDED|95.0|-0.77|3.81||This p-value is from a 2 degree of freedom F-test to compare the 3 arms using analysis of variance.|ANOVA|||Mean differences between baseline and year 2 were compared among the 3 arms using analysis of variance.||3.81|-0.77|0.16
72359865|NCT01183689|144231479|SUPERIORITY||Mean Difference (Net)|2.21||||0.16|TWO_SIDED|95.0|-0.09|4.51||This p-value is from a 2 degree of freedom F test.|ANOVA|||Analysis of variance was used to compared mean differences among the 3 groups.||4.51|-0.09|0.16
72359866|NCT01183689|144231480|SUPERIORITY||Mean Difference (Net)|0.17||||0.75|TWO_SIDED|95.0|-3.89|4.23||This p-value is from a 2 degree of freedom F-test from analysis of variance.|ANOVA|||Mean changes from baseline to year 2 among the 3 arms were compared using analysis of variance.||4.23|-3.89|0.75
72359867|NCT01183689|144231480|SUPERIORITY||Mean Difference (Net)|1.44||||0.75|TWO_SIDED|95.0|-2.61|5.49||This p-value is from a 2 degree of freedom test.|ANOVA||No significant differences between groups 1 and 3.|Analysis of variance was used to compare mean changes among the 3 groups.||5.49|-2.61|0.75
72359868|NCT01183689|144231481|SUPERIORITY||Mean Difference (Net)|-1.08||||0.05|TWO_SIDED|95.0|-2.44|0.28||This p-value is from a 2 degree of freedom F-test to compare the 3 arms within an analysis of variance.|ANOVA||No significant difference between groups 1 and 2.|Mean changes from baseline to year 2 among the 3 arms were compared using analysis of variance.||0.28|-2.44|0.05
72359869|NCT01183689|144231481|SUPERIORITY||Mean Difference (Net)|-1.66||||0.05|TWO_SIDED|95.0|-3.0|-0.32||This p-value is from an F-test to compare differences among the 3 groups.|ANOVA|||Analysis of variance was used to compare mean differences in changes from baseline to 2 years among the 3 groups.||-0.32|-3.00|0.05
72359870|NCT01183689|144231482|SUPERIORITY||Mean Difference (Net)|-0.46||||0.03|TWO_SIDED|95.0|-1.37|0.45||This p-value is from a 2 degree of freedom F-test from an analysis of variance to assess differences among the 3 arms.|ANOVA|||Mean changes between baseline and year 2 were compared among the 3 arms using analysis of variance.||0.45|-1.37|0.03
72359871|NCT01183689|144231482|SUPERIORITY||Mean Difference (Net)|-1.21||||0.03|TWO_SIDED|95.0|-2.11|-0.3||This p-value is from a 2 degree of freedom F-test to compare differences among the 3 groups.|ANOVA|||Analysis of variance was used to compare mean differences from baseline to 2 years among the 3 groups.||-0.30|-2.11|0.03
72359872|NCT01183689|144231483|SUPERIORITY||Mean Difference (Net)|1.08||||0.2|TWO_SIDED|95.0|-0.84|3.0||This p-value is from a 2 degree of freedom F-test from an analysis of variance to assess mean differences among the 3 arms.|ANOVA||The 95% confidence interval for differences between groups 1 and 2 includes 0.|Mean differences from baseline to year 2 among the 3 arms were assessed using analysis of variance.||3.00|-0.84|0.20
72359873|NCT01183689|144231483|SUPERIORITY||Mean Difference (Net)|-0.05||||0.2|TWO_SIDED|95.0|-1.45|1.35||This p-value is from an analysis of variance comparing all 3 groups.|ANOVA||The 95% confidence interval for differences between groups 1 and 3 includes 0.|Analysis of variance was used to compare differences among the 3 groups.||1.35|-1.45|0.20
72359874|NCT01183689|144231484|SUPERIORITY||Mean Difference (Net)|-0.12||||0.02|TWO_SIDED|95.0|-0.34|0.1||2 degree of freedom F-test from analysis of variance, with no adjustment for multiple outcomes|ANOVA|||2 degree of freedom F-test to compare mean 2 year differences among 3 arms||0.10|-0.34|0.02
72359875|NCT01183689|144231484|SUPERIORITY||Mean Difference (Net)|-0.3||||0.02|TWO_SIDED|95.0|-0.52|-0.08||This p-value is from a 2 degree of freedom test for differences among the 3 groups.|ANOVA|||Analysis of variance was used to compare mean differences in changes from baseline to 2 years among the 3 groups.||-0.08|-0.52|0.02
72359876|NCT01183689|144231485|SUPERIORITY||Mean Difference (Net)|-52.0||||0.58|TWO_SIDED|95.0|-164.0|60.0||2 degree of freedom F-test to compare 3 arms with respect to 2-year changes in kilocalories|ANOVA|||2 degree of freedom F-test to compare mean differences among 3 arms in changes in kilocalories from baseline to year 2||60|-164|0.58
72359877|NCT01183689|144231485|SUPERIORITY||Mean Difference (Net)|-50.0||||0.58|TWO_SIDED|95.0|-162.0|61.0||This p-value is from a 2 degree of freedom F-test to compare differences among the 3 groups|ANOVA|||Analysis of variance was used to assess mean differences in 2 year changes in kilocalories intake among the 3 groups.||61|-162|0.58
72359878|NCT01183689|144231486|SUPERIORITY||Mean Difference (Net)|-1.27||||0.001|TWO_SIDED|95.0|-2.55|0.02||2 degree of freedom F-test from analysis of variance to compare changes in waist circumference from baseline among the three arms|ANOVA|No adjustment to degrees of freedom|Difference between groups 1 and 2: 95% confidence interval includes 0|2 degree of freedom F-test from ANOVA to compare differences among 3 arms||0.02|-2.55|0.001
72359879|NCT01183689|144231486|SUPERIORITY||Mean Difference (Net)|-2.42||||0.001|TWO_SIDED|95.0|-3.69|-1.14||The p-value is from a 2 degree of freedom F-test for differences among the 3 arms|ANOVA||The 95% confidence interval for differences between groups 1 and 3 does not include 0.|Mean change in waist girth from baseline to year 2||-1.14|-3.69|0.001
72359880|NCT01183689|144231487|SUPERIORITY|Chi-squared test to compare the percentage of participants reporting self-weighing more than once per week among the 3 arms.|Odds Ratio (OR)|1.77||||0.004|TWO_SIDED|95.0|1.04|3.02||This is based on a 2 degree of freedom likelihood ratio test to compare differences among the 3 arms.|Regression, Logistic||The 95% confidence interval for the odds ratio comparing the rates of self-weighing at year 2 between groups 1 and 2 excludes 0.|Logistic regression to compare differences among the 3 groups||3.02|1.04|0.004
72359881|NCT01183689|144231487|SUPERIORITY||Odds Ratio (OR)|2.35||||0.004|TWO_SIDED|95.0|1.4|3.94||2 degree of freedom likelihood ratio statistic to compare differences among the 3 arms|Regression, Logistic|No adjustments|The 95% confidence interval for the odds ratio comparing groups 1 and 3 excludes 0.|Logistic regression analysis was used to compare the rates of daily self-weighing at 2 years among the 3 groups.||3.94|1.40|0.004
72359882|NCT01419236|144231489|SUPERIORITY_OR_OTHER||LS Mean Difference|0.66||||0.38|TWO_SIDED|90.0|-0.59|1.91|||Mixed Models Repeated Measure Analysis|||||1.91|-0.59|0.380
72359883|NCT01419236|144231490|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.44||||0.164|TWO_SIDED|90.0|-0.96|0.08|||Mixed Models Repeated Measures Analysis|||||0.08|-0.96|0.164
72359884|NCT01419236|144231491|SUPERIORITY_OR_OTHER||LS Mean Difference|0.42||||0.342|TWO_SIDED|90.0|-0.31|1.15|||Mixed Models Repeated Measure Analysis|||||1.15|-0.31|0.342
72359885|NCT01419236|144231492|SUPERIORITY_OR_OTHER||LS Mean Difference|0.81||||0.079|TWO_SIDED|90.0|0.05|1.57|||Mixed Models Repeated Measure Analysis|||||1.57|0.05|0.079
72359886|NCT01419236|144231493|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3||||0.535|TWO_SIDED|90.0|-0.5|1.1|||Mixed Models Repeated Measure Analysis|||||1.10|-0.50|0.535
72359887|NCT01419236|144231494|SUPERIORITY_OR_OTHER||LS Mean Difference|1.03||||0.172|TWO_SIDED|90.0|-0.22|2.27|||ANCOVA|||||2.27|-0.22|0.172
72359888|NCT01419236|144231495|SUPERIORITY_OR_OTHER||LS Mean Difference|0.32||||0.473|TWO_SIDED|90.0|-0.41|1.04|||Mixed Models Repeated Measure Analysis|||||1.04|-0.41|0.473
72359889|NCT01419236|144231496|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.08||||0.885|TWO_SIDED|90.0|-1.03|0.87|||Mixed Models Repeated Measure Analysis|||||0.87|-1.03|0.885
72359890|NCT01419236|144231497|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.03||||0.938|TWO_SIDED|90.0|-0.61|0.55|||Mixed Models Repeated Measure Analysis|||||0.55|-0.61|0.938
72359891|NCT02849418|144231500|OTHER||Mean Difference (Net)|-3.02|||||TWO_SIDED|95.0|-5.85|-0.19|||||The analysis method was mixed-model for repeated measures (MMRM) with treatment, visit, treatment-by-visit interaction, Baseline value, Baseline-by-visit interaction as fixed effects.|||-0.19|-5.85|
72359892|NCT00762359|144231584|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.0989|||<|0.0001|TWO_SIDED|95.0|0.0425|0.23|||Log Rank|||||0.2300|0.0425|<0.0001
72359893|NCT00762359|144231585|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.0001
72359894|NCT00762359|144231586|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.0001
72359895|NCT00762359|144231587|SUPERIORITY_OR_OTHER|||||||0.0079||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0079
72359896|NCT00762359|144231588|SUPERIORITY_OR_OTHER|||||||0.0433||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0433
72359897|NCT00762359|144231590|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.0001
72359898|NCT00762359|144231591|SUPERIORITY_OR_OTHER|||||||0.0006||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0006
72359899|NCT00762359|144231592|SUPERIORITY_OR_OTHER|||||||0.0025||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0025
72359900|NCT00762359|144231593|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0010
72359901|NCT00762359|144231595|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Log Rank|||||||<0.0001
72359902|NCT00762359|144231596|SUPERIORITY_OR_OTHER|||||||0.6148||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.6148
72359903|NCT00762359|144231597|SUPERIORITY_OR_OTHER|||||||0.805||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.8050
72359904|NCT00762359|144231598|SUPERIORITY_OR_OTHER|||||||0.8678||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.8678
72359905|NCT00762359|144231599|SUPERIORITY_OR_OTHER|||||||0.2688||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.2688
72359906|NCT00762359|144231601|SUPERIORITY_OR_OTHER|||||||0.7054||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.7054
72359907|NCT00762359|144231602|SUPERIORITY_OR_OTHER|||||||0.34||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.3400
72359908|NCT00762359|144231603|SUPERIORITY_OR_OTHER|||||||0.8813||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.8813
72359909|NCT00762359|144231604|SUPERIORITY_OR_OTHER|||||||0.1862||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.1862
72359910|NCT00762359|144231606|SUPERIORITY_OR_OTHER|||||||0.8604||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.8604
72359911|NCT00762359|144231607|SUPERIORITY_OR_OTHER|||||||0.5485||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.5485
72359912|NCT00762359|144231608|SUPERIORITY_OR_OTHER|||||||0.7382||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.7382
72359913|NCT00762359|144231609|SUPERIORITY_OR_OTHER|||||||0.7619||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.7619
72359914|NCT00762359|144231611|SUPERIORITY_OR_OTHER|||||||0.0204||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0204
72359915|NCT00762359|144231612|SUPERIORITY_OR_OTHER|||||||0.0046||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0046
72359916|NCT00762359|144231613|SUPERIORITY_OR_OTHER|||||||0.0059||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0059
72359917|NCT00762359|144231614|SUPERIORITY_OR_OTHER|||||||0.1229||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.1229
72359918|NCT00762359|144231616|SUPERIORITY_OR_OTHER|||||||0.2694||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.2694
72359919|NCT00762359|144231617|SUPERIORITY_OR_OTHER|||||||0.0141||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0141
72359920|NCT00762359|144231618|SUPERIORITY_OR_OTHER|||||||0.3128||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.3128
72359921|NCT00762359|144231619|SUPERIORITY_OR_OTHER|||||||0.145||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.1450
72359922|NCT00762359|144231621|SUPERIORITY_OR_OTHER|||||||0.6175||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.6175
72359923|NCT00762359|144231622|SUPERIORITY_OR_OTHER|||||||0.4496||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.4496
72359924|NCT00762359|144231623|SUPERIORITY_OR_OTHER|||||||0.4718||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.4718
72359925|NCT00762359|144231624|SUPERIORITY_OR_OTHER|||||||0.4484||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.4484
72359926|NCT00762359|144231626|SUPERIORITY_OR_OTHER|||||||0.2604||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.2604
72359927|NCT00762359|144231627|SUPERIORITY_OR_OTHER|||||||0.6818||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.6818
72359928|NCT00762359|144231628|SUPERIORITY_OR_OTHER|||||||0.9015||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.9015
72359929|NCT00762359|144231629|SUPERIORITY_OR_OTHER|||||||0.4497||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.4497
72359930|NCT03287791|144231668|SUPERIORITY||Mean Difference (Final Values)|-11.27|||<|0.0001|TWO_SIDED|95.0|-16.8|-5.73|||ANOVA|||Analyses was performed using an Analysis of Variance (ANOVA) model with percent change from baseline to Week 12 in the lesion count as outcome and treatment, center and treatment-by-center interaction as factors.||-5.73|-16.80|<.0001
72359931|NCT03287791|144231668|SUPERIORITY||Median Difference (Final Values)|-9.71||||0.0007|TWO_SIDED|95.0|-15.28|-4.14|||ANOVA|||Analyses was performed using an ANOVA model with percent change from baseline to Week 12 in the lesion count as outcome and treatment, center and treatment-by-center interaction as factors.||-4.14|-15.28|0.0007
72359932|NCT02250326|144231687|SUPERIORITY||Hazard Ratio (HR)|1.3|||||TWO_SIDED|95.0|0.9|1.94||||Based on stratification factors of ECOG Performance Status (0 or 1), sex (male or female), and current smoker status (yes or no).||Based on stratified Cox proportional hazards regression model.||1.94|0.90|
72359933|NCT02250326|144231688|SUPERIORITY||Disease Control Rate Ratio|0.97|||||TWO_SIDED|95.0|0.778|1.207|||||95% CI was calculated using Clopper-Pearson method.||Direction of Disease Control Rate Ratio is DCR of Nab-Paclitaxel + CC-486 Combination Arm over DCR of Nab-Paclitaxel Alone|1.207|0.778|
72359934|NCT02250326|144231689|SUPERIORITY||Overall Response Rate Ratio|0.84|||||TWO_SIDED|95.0|0.398|1.754|||||95% CI was calculated using Clopper-Pearson method.||Direction of Overall Response Rate Ratio is ORR of Nab-Paclitaxel + CC-486 Combination Arm over ORR of nab-Paclitaxel Alone.|1.754|0.398|
72359935|NCT02250326|144231690|SUPERIORITY||Hazard Ratio (HR)|1.7|||||TWO_SIDED|95.0|1.08|2.57||||Based on stratification factors of ECOG performance status (0 or 1), sex (male or female), and current smoker status (yes or no).||Based on stratified Cox proportional hazards regression model.||2.57|1.08|
72359936|NCT04673214|144231697|SUPERIORITY|The null hypothesis for the modification in the clinical evolution of the conjunctivitis sign in patients diagnosed with COVID-19 under early intervention treatment with Azithromycin / Ribaroxaban / Paracetamol for 14 days followed by video call is rejected.||||||0.05||||||Presence of a p \<0.05 as significant in the comparison of treatment with clinical symptoms|Chi-squared|||Null Hypothesis: There will be no modification in the clinical evolution ≥ 25% of patients diagnosed with COVID-19 under an early intervention treatment with Azithromycin / Ivermectin / Ribaroxaban / Paracetamol vs. Azithromycin / Ribaroxaban / Paracetamol for 14 days followed by video call from U.M.F 13 and U.M.F 20 from I.M.S.S., during the period of December 2020- February 2021, with a power of 90%, type I error rate 1% and loss to follow-up 20%.||||0.05
72359937|NCT04673214|144231697|SUPERIORITY|The null hypothesis is rejected with a difference of 2 days in the modification of the clinical evolution (symptoms of fever, cough, headache, myalgia, odynophagia, anosmia, rhinorrhea, arthralgia, chest pain, dyspnea, conjunctivitis) of patients diagnosed with COVID -19 in early intervention treatment. vs. therapeutic failure, for 14 days followed by video call, with a power of 90%, a type I error rate of 1% and a loss to follow-up of 20%||||||0.05|||||||t-test, 2 sided|||Assuming a difference of 2 days in the modification of the clinical course (symptoms of fever, cough, headache, myalgia, odynophagia, anosmia, rhinorrhea, arthralgia, chest pain, dyspnea, conjunctivitis) of patients diagnosed with COVID-19 in early intervention treatment vs. therapeutic failure, for 14 days followed by video call, with a power of 90%, a type I error rate of 1% and a loss to follow-up of the twenty%||||0.05
72359938|NCT04673214|144231698|SUPERIORITY|Assuming a difference in the percentage of effectiveness in the clinical modification and therapeutic failure of patients diagnosed with the outcome of improvement in the Modification of the clinical evolution of the symptoms of patients with COVID-19 using double therapy was reported 95.7% (n = 44) Vs. triple therapy 90.8% (n = 59) and therapeutic failure 4.3% (n = 2) vs. 9.2% (n = 6), respectively.||||||0.05||||||Presence of a p \<0.05 as significant in the comparison of treatment with clinical symptoms the clinical modification and therapeutic failure of patients diagnosed with COVID-19|Chi-squared|||Assuming a difference in the percentage of effectiveness in the clinical modification and therapeutic failure of patients diagnosed with COVID-19 under treatment with Azithromycin / Ivermectin / Ribaroxaban / Paracetamol vs. Azithromycin / Ribaroxaban / Paracetamol followed for 14 days followed by video call, with a power of 90%, a type I error rate of 1% and a loss to follow-up of 20%||||0.05
72359939|NCT04673214|144231699|SUPERIORITY|The null hypothesis is rejected with a mean duration of 2 days with clinical symptoms of COVID-19 in early intervention treatment as a result of improving the modification of the clinical evolution of symptoms vs therapeutic failure.||||||0.05|||||||t-test, 2 sided|||Assuming a difference in days of effectiveness in clinical modification and therapeutic failure of patients diagnosed with COVID-19 in treatment with Azithromycin / Ivermectin / Ribaroxaban / Paracetamol vs. Azithromycin / Ribaroxaban / Paracetamol followed for 14 days followed by video call, with a potency 90%, a Type I error rate of 1%, and a loss to follow-up of 20%||||0.05
72359940|NCT04673214|144231700|SUPERIORITY|A total of 62 patients was calculated, however due to the availability of medication, it was recalculated to 111 patients, that is, 65 cases in the triple therapy group and 46 in the double therapy group would be necessary for the analysis.||||||0.05|||||||Wilcoxon (Gehan) statistical test|||Assuming a 25% efficacy in modifying the clinical course (COVID-19 mild phase symptoms) of patients with COVID-19 under a comparative treatment for 14 days followed by video call, with a power of 90%, type I error rate 1% and loss to follow-up 20%||||0.05
72359941|NCT02646826|144231710|SUPERIORITY|||||||0.0017|||||||ANOVA|||||||0.0017
72359942|NCT02646826|144231711|SUPERIORITY||||||<|0.44|||||||ANOVA|||||||<.44
72359943|NCT00614575|144231718|SUPERIORITY_OR_OTHER||Mean change from baseline|-7.2|STANDARD_DEVIATION|9.0|<|0.0001|||||||Paired t-test|||||||<0.0001
72359944|NCT00614575|144231719|SUPERIORITY_OR_OTHER||Mean change from baseline|-4.8|STANDARD_DEVIATION|7.8|<|0.0001|||||||Paired t-test|||||||<0.0001
72359945|NCT00614575|144231720|SUPERIORITY_OR_OTHER||Mean change from baseline|-0.7|STANDARD_DEVIATION|0.9|<|0.0001|||||||paired t-test|||||||<0.0001
72359946|NCT00614575|144231721|SUPERIORITY_OR_OTHER||mean change from baseline|-0.3|STANDARD_DEVIATION|0.6|<|0.0001|||||||paired t-test|||||||<0.0001
72359947|NCT04571944|144231751|SUPERIORITY||Difference in % vs Placebo|-8.7||||0.129|TWO_SIDED|95.0|-20.1|2.6|||Miettinen and Nurminen method|Analysis was stratified by hospitalization reason (acute disease, elective surgery) and age category (\<75 years, ≥75 years).||||2.6|-20.1|0.129
72359948|NCT04571944|144231752|OTHER||Difference in % vs. Placebo|0.8|||||TWO_SIDED|95.0|-9.3|11.0||||||||11.0|-9.3|
72359949|NCT04571944|144231753|OTHER||Difference in % vs. Placebo|0.0|||||TWO_SIDED|95.0|-5.1|5.2||||||||5.2|-5.1|
72359950|NCT04571944|144231754|SUPERIORITY||Difference vs. Placebo|-0.5||||0.485|TWO_SIDED|95.0|-2.0|1.0||Based on aligned rank test.|Hodges-Lehmann method|||||1.0|-2.0|0.485
72359951|NCT04571944|144231755|SUPERIORITY||Difference in % vs. Placebo|-8.6||||0.136|TWO_SIDED|95.0|-20.2|2.8|||Miettinen and Nurminen method|Analysis was stratified by hospitalization reason (acute disease, elective surgery) and age category (\<75 years, ≥75 years).||||2.8|-20.2|0.136
72359952|NCT01650558|144231758|NON_INFERIORITY|Will assess performance of each experimental group relative to TS with a noninferiority margin for 1-HR of 0.35 to test the null (1-HR ≥ 0.35) and alternative (1-HR \< 0.35) hypotheses. Each experimental group will be declared noninferior to TS if the upper bound of the 95% confidence interval of 1-HR is below 0.35. For ease of interpretation, the HRs have been recast with TS as the reference group, such that HRs greater than 1 indicate an increase in the experimental hazard rate relative to TS.|Hazard Ratio (HR)|1.27|||<=|0.05|TWO_SIDED|95.0|0.89|1.82||P-Value is not adjusted for multiple comparisons.|Poisson|Rate ratio confidence intervals and p-values were adjusted for overdispersion using the Pearson's chi-square scale.||||1.82|0.89|<=0.05
72359953|NCT01650558|144231758|NON_INFERIORITY|Will assess performance of each experimental group relative to TS with a noninferiority margin for 1-HR of 0.35 to test the null (1-HR ≥ 0.35) and alternative (1-HR \< 0.35) hypotheses. Each experimental group will be declared noninferior to TS if the upper bound of the 95% confidence interval of 1-HR is below 0.35. For ease of interpretation, the HRs have been recast with TS as the reference group, such that HRs greater than 1 indicate an increase in the experimental hazard rate relative to TS.|Hazard Ratio (HR)|1.28|||<=|0.05|TWO_SIDED|95.0|0.89|1.83||P-Value is not adjusted for multiple comparisons.|Poisson|Rate ratio confidence intervals and p-values were adjusted for overdispersion using the Pearson's chi-square scale.||||1.83|0.89|<=0.05
72359954|NCT01650558|144231759|NON_INFERIORITY|Will assess performance of each experimental group relative to TS with a noninferiority margin for 1-HR of 0.35 to test the null (1-HR ≥ 0.35) and alternative (1-HR \< 0.35) hypotheses. Each experimental group will be declared noninferior to TS if the upper bound of the 95% confidence interval of 1-HR is below 0.35. For ease of interpretation, the HRs have been recast with TS as the reference group, such that HRs greater than 1 indicate an increase in the experimental hazard rate relative to TS.|Hazard Ratio (HR)|1.38|||<=|0.05|TWO_SIDED|95.0|0.83|2.3||No adjustment for multiple comparisons was made.|Fisher Exact|||||2.30|0.83|<=0.05
72359955|NCT01650558|144231759|NON_INFERIORITY|Will assess performance of each experimental group relative to TS with a noninferiority margin for 1-HR of 0.35 to test the null (1-HR ≥ 0.35) and alternative (1-HR \< 0.35) hypotheses. Each experimental group will be declared noninferior to TS if the upper bound of the 95% confidence interval of 1-HR is below 0.35. For ease of interpretation, the HRs have been recast with TS as the reference group, such that HRs greater than 1 indicate an increase in the experimental hazard rate relative to TS.|Hazard Ratio (HR)|1.51|||<=|0.05|TWO_SIDED|95.0|0.91|2.49||No adjustment for multiple comparisons was made.|Fisher Exact|||||2.49|0.91|<=0.05
72359956|NCT01650558|144231760|NON_INFERIORITY|Will assess performance of each experimental group relative to TS with a noninferiority margin for 1-HR of 0.35 to test the null (1-HR ≥ 0.35) and alternative (1-HR \< 0.35) hypotheses. Each experimental group will be declared noninferior to TS if the upper bound of the 95% confidence interval of 1-HR is below 0.35. For ease of interpretation, the HRs have been recast with TS as the reference group, such that HRs greater than 1 indicate an increase in the experimental hazard rate relative to TS.|Hazard Ratio (HR)|1.13|||<=|0.05|TWO_SIDED|95.0|0.66|1.93||No adjustments for multiple comparisons were made.|Fisher Exact|||||1.93|0.66|<=0.05
72359957|NCT01650558|144231760|NON_INFERIORITY|Will assess performance of each experimental group relative to TS with a noninferiority margin for 1-HR of 0.35 to test the null (1-HR ≥ 0.35) and alternative (1-HR \< 0.35) hypotheses. Each experimental group will be declared noninferior to TS if the upper bound of the 95% confidence interval of 1-HR is below 0.35. For ease of interpretation, the HRs have been recast with TS as the reference group, such that HRs greater than 1 indicate an increase in the experimental hazard rate relative to TS.|Hazard Ratio (HR)|0.96|||<=|0.05|TWO_SIDED|95.0|0.55|1.68||No adjustments for multiple comparisons were made.|Fisher Exact|||||1.68|0.55|<=0.05
72359958|NCT01650558|144231761|NON_INFERIORITY|Will assess performance of each experimental group relative to TS with a noninferiority margin for 1-HR of 0.35 to test the null (1-HR ≥ 0.35) and alternative (1-HR \< 0.35) hypotheses. Each experimental group will be declared noninferior to TS if the upper bound of the 95% confidence interval of 1-HR is below 0.35. For ease of interpretation, the HRs have been recast with TS as the reference group, such that HRs greater than 1 indicate an increase in the experimental hazard rate relative to TS.|Hazard Ratio (HR)|1.47|||<=|0.05|TWO_SIDED|95.0|1.07|2.0||No adjustments for multiple comparisons were made.|Poisson|Rate ratio confidence intervals and p-values were adjusted for overdispersion using the Pearson's chi-square scale.||||2.00|1.07|<=0.05
72359959|NCT01650558|144231761|NON_INFERIORITY|Will assess performance of each experimental group relative to TS with a noninferiority margin for 1-HR of 0.35 to test the null (1-HR ≥ 0.35) and alternative (1-HR \< 0.35) hypotheses. Each experimental group will be declared noninferior to TS if the upper bound of the 95% confidence interval of 1-HR is below 0.35. For ease of interpretation, the HRs have been recast with TS as the reference group, such that HRs greater than 1 indicate an increase in the experimental hazard rate relative to TS.|Hazard Ratio (HR)|1.43|||<=|0.05|TWO_SIDED|95.0|1.04|1.96||No adjustments for multiple comparisons were made.|Poisson|Rate ratio confidence intervals and p-values were adjusted for overdispersion using the Pearson's chi-square scale.||||1.96|1.04|<=0.05
72359960|NCT01650558|144231762|NON_INFERIORITY|Will assess performance of each experimental group relative to TS with a noninferiority margin for 1-HR of 0.35 to test the null (1-HR ≥ 0.35) and alternative (1-HR \< 0.35) hypotheses. Each experimental group will be declared noninferior to TS if the upper bound of the 95% confidence interval of 1-HR is below 0.35. For ease of interpretation, the HRs have been recast with TS as the reference group, such that HRs greater than 1 indicate an increase in the experimental hazard rate relative to TS.|Hazard Ratio (HR)|1.31|||<=|0.05|TWO_SIDED|95.0|1.11|1.55||No adjustments for multiple comparisons were made.|Poisson|Rate ratio confidence intervals and p-values were adjusted for overdispersion using the Pearson's chi-square scale.||||1.55|1.11|<=0.05
72359961|NCT01650558|144231762|NON_INFERIORITY|Will assess performance of each experimental group relative to TS with a noninferiority margin for 1-HR of 0.35 to test the null (1-HR ≥ 0.35) and alternative (1-HR \< 0.35) hypotheses. Each experimental group will be declared noninferior to TS if the upper bound of the 95% confidence interval of 1-HR is below 0.35. For ease of interpretation, the HRs have been recast with TS as the reference group, such that HRs greater than 1 indicate an increase in the experimental hazard rate relative to TS.|Hazard Ratio (HR)|1.34|||<=|0.05|TWO_SIDED|95.0|1.14|1.58||No adjustments for multiple comparisons were made.|Poisson|Rate ratio confidence intervals and p-values were adjusted for overdispersion using the Pearson's chi-square scale.||||1.58|1.14|<=0.05
72359962|NCT01069484|144231776|NON_INFERIORITY_OR_EQUIVALENCE|Power calculation was based on the study by Mørkved and Bø (1997), showing 67% prevalence reduction of UI in the PFMT group and 34% reduction in the control group. Assuming a similar effect, two-sided significance of \<0.05, and a power of 0.90, required a total of 62 women. Stratified analysis on major levator ani (LA) muscle defects was planned, but the effect of PFMT in women with such defects was unknown. The statistical advice was to aim for 80 women with- and 80 women without such defects.|Risk Ratio (RR)|0.89||||0.57|TWO_SIDED|95.0|0.6|1.32||P-values \< 0.05 were considered significant.|Mantel Haenszel||"Pelvic floor muscle training arm represents the numerator for relative risk and usual care arm represents the denominator for relative risk"|"Intention to treat was the principal analysis. Missing values for categorical data (self-reported UI) the approach of last observation carried forward was used."||1.32|0.60|0.57
72359963|NCT01069484|144231777|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.84||||0.51|TWO_SIDED|95.0|0.49|1.42||P-values \< 0.05 were considered significant.|Mantel Haenszel||"Pelvic floor muscle training arm represents the numerator for relative risk and usual care arm represents the denominator for relative risk"|"Intention to treat was the principal analysis. Missing values for categorical data (self-reported UI) the approach of last observation carried forward was used."||1.42|0.49|0.51
72359964|NCT02732600|144231781|SUPERIORITY||Mean Difference (Final Values)|0.51|STANDARD_ERROR_OF_MEAN|0.59||0.39|TWO_SIDED|95.0|-0.66|1.68|||t-test, 2 sided|||Analysis 1 is Comparison Across Conditions at BASELINE Analysis 2 is Comparison Across Conditions at 6 Months Analysis 3 is Comparison Across Conditions at 1 year||1.68|-0.66|0.39
72359965|NCT02732600|144231781|SUPERIORITY||Mean Difference (Final Values)|0.65|STANDARD_ERROR_OF_MEAN|0.71||0.35|TWO_SIDED|95.0|-0.75|2.06|||t-test, 2 sided|||Analysis 1 is Comparison Across Conditions at BASELINE Analysis 2 is Comparison Across Conditions at 6 Months Analysis 3 is Comparison Across Conditions at 1 year||2.06|-0.75|0.35
72359966|NCT02732600|144231781|SUPERIORITY||Mean Difference (Final Values)|1.01|STANDARD_ERROR_OF_MEAN|0.81||0.21|TWO_SIDED|95.0|-0.57|2.6|||t-test, 2 sided|||Analysis 1 is Comparison Across Conditions at BASELINE Analysis 2 is Comparison Across Conditions at 6 Months Analysis 3 is Comparison Across Conditions at 1 year||2.60|-0.57|0.21
72359967|NCT02732600|144231782|SUPERIORITY||Mean Difference (Final Values)|5.61|STANDARD_ERROR_OF_MEAN|3.6||0.156|TWO_SIDED|95.0|-2.2|13.48|||t-test, 2 sided|||t-test used to compare group differences in Cohesiveness at BASELINE||13.48|-2.2|0.156
72359968|NCT02732600|144231782|SUPERIORITY||Mean Difference (Final Values)|7.97|STANDARD_ERROR_OF_MEAN|5.89||0.182|TWO_SIDED|95.0|-3.85|19.8|||t-test, 2 sided|||t-test to compare group means on Communication at BASELINE||19.8|-3.85|0.182
72359969|NCT02732600|144231782|SUPERIORITY||Mean Difference (Final Values)|8.41|STANDARD_ERROR_OF_MEAN|6.31||0.234|TWO_SIDED|95.0|-5.74|22.57|||t-test, 2 sided|||t-test to compare group differences on Role Clarity at BASELINE||22.57|-5.74|0.234
72359970|NCT02732600|144231782|SUPERIORITY||Mean Difference (Final Values)|14.14|STANDARD_ERROR_OF_MEAN|9.63||0.149|TWO_SIDED|95.0|-5.22|33.5|||t-test, 2 sided|||t-test to compare group values on Goals at Baseline||33.5|-5.22|0.149
72359971|NCT02732600|144231782|SUPERIORITY||Mean Difference (Final Values)|-0.47|STANDARD_ERROR_OF_MEAN|7.1||0.947|TWO_SIDED|95.0|-14.7|13.8|||t-test, 2 sided|||t-test of differences between groups on Cohesiveness at 6-Months||13.8|-14.7|0.947
72359972|NCT02732600|144231782|SUPERIORITY||Mean Difference (Final Values)|1.38|STANDARD_ERROR_OF_MEAN|8.4||0.87|TWO_SIDED|95.0|-15.6|18.4|||t-test, 2 sided|||t-test of groups differences on Communication at 6 Months||18.4|-15.6|0.870
72359973|NCT02732600|144231782|SUPERIORITY||Mean Difference (Final Values)|6.18|STANDARD_ERROR_OF_MEAN|8.62||0.478|TWO_SIDED|95.0|-11.26|23.63|||t-test, 2 sided|||t-test of group differences on Role Clarity at 6 months||23.63|-11.26|0.478
72359974|NCT02732600|144231782|SUPERIORITY||Mean Difference (Final Values)|2.23|STANDARD_ERROR_OF_MEAN|7.71||0.773|TWO_SIDED|95.0|-13.35|17.83|||t-test, 2 sided|||t-test of group differences on Goals at 6 Months||17.83|-13.35|0.773
72359975|NCT02732600|144231782|SUPERIORITY||Mean Difference (Final Values)|9.09|STANDARD_ERROR_OF_MEAN|9.8||0.498|TWO_SIDED|95.0|-20.4|38.6|||t-test, 2 sided|||t-test of group differences on Cohesiveness at 1year||38.6|-20.4|0.498
72359976|NCT02732600|144231782|SUPERIORITY||Mean Difference (Final Values)|3.21|STANDARD_ERROR_OF_MEAN|11.4||0.78|TWO_SIDED|95.0|-20.3|26.7|||t-test, 2 sided|||t-test of group differences on Communication at 1 year||26.7|-20.3|0.780
72359977|NCT02732600|144231782|SUPERIORITY||Mean Difference (Final Values)|11.46|STANDARD_ERROR_OF_MEAN|12.54||0.474|TWO_SIDED|95.0|-23.19|46.11|||t-test, 2 sided|||t-test of group differences on Role Clarity at 1 year||46.11|-23.19|0.474
72359978|NCT02732600|144231782|SUPERIORITY||Mean Difference (Final Values)|10.0|STANDARD_ERROR_OF_MEAN|8.78||0.267|TWO_SIDED|95.0|-8.21|28.21|||t-test, 2 sided|||t-test of group differences on Goals at 1 year||28.21|-8.21|0.267
72359979|NCT02732600|144231783|SUPERIORITY||Mean Difference (Final Values)|0.45|STANDARD_ERROR_OF_MEAN|0.38||0.098|TWO_SIDED|95.0|-0.09|1.0|||t-test, 2 sided|||t test comparison across groups on CORE PEER at 6 months||1.00|-0.09|0.098
72359980|NCT02732600|144231783|SUPERIORITY||Mean Difference (Final Values)|0.5|STANDARD_ERROR_OF_MEAN|1.1||0.282|TWO_SIDED|95.0|-0.43|1.43|||t-test, 2 sided|||t-test comparison across groups on COLLABORATION at 6 months||1.43|-0.43|0.282
72359981|NCT02732600|144231783|SUPERIORITY||Mean Difference (Final Values)|1.1|STANDARD_ERROR_OF_MEAN|0.56||0.06|TWO_SIDED|95.0|-0.05|2.29|||t-test, 2 sided|||t-test comparison across groups on PEER SPECIALIST AS LIAISON at 6 months||2.29|-0.05|0.06
72359982|NCT02732600|144231783|SUPERIORITY||Mean Difference (Final Values)|0.83|STANDARD_ERROR_OF_MEAN|0.86||0.34|TWO_SIDED|95.0|0.07|1.59|||t-test, 2 sided|||t-test comparison across groups on PROVIDES INFO ON SERVICES at 6 months||1.59|0.07|0.34
72359983|NCT02732600|144231783|SUPERIORITY||Mean Difference (Final Values)|0.83||||0.34|TWO_SIDED|95.0|-0.94|2.62|||t-test, 2 sided|||t-test comparison across groups on Symptoms and Medication at 6-months||2.62|-0.94|0.34
72359984|NCT02732600|144231783|SUPERIORITY||Mean Difference (Final Values)|0.28|STANDARD_ERROR_OF_MEAN|0.64||0.66|TWO_SIDED|95.0|-1.03|1.5|||t-test, 2 sided|||t-test comparison across groups on Training and Preparation at 6-months||1.50|-1.03|0.66
72359985|NCT02732600|144231783|SUPERIORITY||Mean Difference (Final Values)|0.9|STANDARD_ERROR_OF_MEAN|0.61||0.15|TWO_SIDED|95.0|-0.36|2.16|||t-test, 2 sided|||t-test comparison across groups on Team Integration and Relationships at 6 Months||2.16|-0.36|0.15
72359986|NCT02732600|144231783|SUPERIORITY||Mean Difference (Final Values)|-0.21|STANDARD_ERROR_OF_MEAN|0.39||0.59|TWO_SIDED|95.0|-1.01|0.59|||t-test, 2 sided|||t-test comparison across groups on Leadership at 6-months||0.59|-1.01|0.59
72359987|NCT02732600|144231783|SUPERIORITY||Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.84||0.95|TWO_SIDED|95.0|-1.77|1.68|||t-test, 2 sided|||t-test comparison across groups on Fits to Experience at 6 months||1.68|-1.77|0.95
72359988|NCT02732600|144231783|SUPERIORITY||Mean Difference (Final Values)|0.55|STANDARD_ERROR_OF_MEAN|0.55||0.32|TWO_SIDED|95.0|-0.58|1.68|||t-test, 2 sided|||t-test comparison across groups on Role Clarity at 6 months||1.68|-0.58|0.32
72359989|NCT02732600|144231783|SUPERIORITY||Mean Difference (Final Values)|0.72|STANDARD_ERROR_OF_MEAN|0.64||0.27|TWO_SIDED|95.0|-0.6|2.04|||t-test, 2 sided|||t-test comparison across both groups on Resources at 6 months||2.04|-0.60|0.27
72359990|NCT02732600|144231783|SUPERIORITY||Mean Difference (Final Values)|0.07|STANDARD_ERROR_OF_MEAN|0.86||0.93|TWO_SIDED|95.0|-1.71|1.85|||t-test, 2 sided|||t-test comparison across groups on Performance Reviews at 6 months||1.85|-1.71|0.93
72359991|NCT02732600|144231783|SUPERIORITY||Mean Difference (Final Values)|-0.73|STANDARD_ERROR_OF_MEAN|0.32||0.15|TWO_SIDED|95.0|-1.45|-0.005|||t-test, 2 sided|||t-test comparison across groups on CORE PEER at 1 year||-0.005|-1.45|0.15
72359992|NCT02732600|144231783|SUPERIORITY||Mean Difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|0.45||0.04|TWO_SIDED|95.0|-1.7|0.32|||t-test, 2 sided|||t-test comparison across groups on Collaboration at 1 year||0.32|-1.7|0.04
72359993|NCT02732600|144231783|SUPERIORITY||Hazard Ratio, log|-0.95|STANDARD_ERROR_OF_MEAN|0.5||0.08|TWO_SIDED|95.0|-2.07|0.17|||t-test, 2 sided|||t-test comparison across groups on Peer Specialists as Liaison at 1 year||0.17|-2.07|0.08
72359994|NCT02732600|144231783|SUPERIORITY||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.39||0.26|TWO_SIDED|95.0|-0.58|0.18|||t-test, 2 sided|||t-test comparison across groups on Provides Info on Services at 1 year||0.18|-0.58|0.26
72359995|NCT02732600|144231783|SUPERIORITY||Mean Difference (Final Values)|-0.85|STANDARD_ERROR_OF_MEAN|1.65||0.61|TWO_SIDED|95.0|-4.53|2.83|||t-test, 2 sided|||t-test comparison between groups on Symptoms and Medication at 1 year||2.83|-4.53|0.61
72359996|NCT02732600|144231783|SUPERIORITY||Mean Difference (Final Values)|-0.93|STANDARD_ERROR_OF_MEAN|0.87||0.3|TWO_SIDED|95.0|-2.87|1.01|||t-test, 2 sided|||t-test comparison across groups on Training and Preparation at 1 year||1.01|-2.87|0.30
72359997|NCT02732600|144231783|SUPERIORITY||Mean Difference (Final Values)|-1.3|STANDARD_ERROR_OF_MEAN|0.35||0.004|TWO_SIDED|95.0|-2.08|-0.52|||t-test, 2 sided|||t-test comparison across groups on Team Integration and Relationships at 1 year||-0.52|-2.08|0.004
72359998|NCT02732600|144231783|SUPERIORITY||Mean Difference (Final Values)|-2.4|STANDARD_ERROR_OF_MEAN|0.81||0.01|TWO_SIDED|95.0|-4.2|-0.6|||t-test, 2 sided|||t-test comparison across groups on Leadership at 1 year||-0.60|-4.20|0.01
72359999|NCT02732600|144231783|SUPERIORITY||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.9||0.9|TWO_SIDED|95.0|-24.1|23.5|||t-test, 2 sided|||t-test comparison across groups on Fits to Experience at 1 year||23.5|-24.1|0.90
72360000|NCT02732600|144231783|SUPERIORITY||Mean Difference (Final Values)|-1.45|STANDARD_ERROR_OF_MEAN|0.7||0.06|TWO_SIDED|95.0|-3.02|0.12|||t-test, 2 sided|||t-test comparison across groups on Role Clarity at 1 year||0.12|-3.02|0.06
72360001|NCT02732600|144231783|SUPERIORITY||Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|0.53||0.71|TWO_SIDED|95.0|-0.97|1.37|||t-test, 2 sided|||t-test comparison across groups on Resources at 1 year||1.37|-0.97|0.71
72360002|NCT02732600|144231783|SUPERIORITY||Mean Difference (Final Values)|-1.4|STANDARD_ERROR_OF_MEAN|1.63||0.41|TWO_SIDED|95.0|-5.03|2.23|||t-test, 2 sided|||t-test comparison on Performance Reviews at 1 year||2.23|-5.03|0.41
72360003|NCT02732600|144231784|SUPERIORITY||Mean Difference (Final Values)|3.59|STANDARD_ERROR_OF_MEAN|1.17||0.002|TWO_SIDED|95.0|1.29|5.88||not adjusted for multiple comparisons|t-test, 2 sided|||Group Comparison at Baseline||5.88|1.29|0.002
72360004|NCT02732600|144231784|SUPERIORITY||Mean Difference (Final Values)|2.62|STANDARD_ERROR_OF_MEAN|1.6||0.1|TWO_SIDED|95.0|-0.54|5.78|||t-test, 2 sided|||Group Comparison at 6 Months||5.78|-0.54|0.10
72360005|NCT02732600|144231784|SUPERIORITY||Mean Difference (Final Values)|0.54|STANDARD_ERROR_OF_MEAN|1.83||0.77|TWO_SIDED|95.0|-3.06|4.14|||t-test, 2 sided|||Group Comparison at 1 year||4.14|-3.06|0.77
72360006|NCT02732600|144231785|SUPERIORITY||Mean Difference (Final Values)|3.47|STANDARD_ERROR_OF_MEAN|1.56||0.02|TWO_SIDED|95.0|0.56|6.38||p value for 1st year only|t-test, 2 sided|||||6.38|0.56|0.02
72360007|NCT02732600|144231785|SUPERIORITY||Mean Difference (Final Values)|0.19|STANDARD_ERROR_OF_MEAN|2.39||0.93|TWO_SIDED|95.0|-4.67|5.04|||t-test, 2 sided|||||5.04|-4.67|0.93
72360008|NCT02732600|144231786|SUPERIORITY||Mean Difference (Final Values)|1.02|STANDARD_ERROR_OF_MEAN|0.2||0.0001|TWO_SIDED|95.0|0.68|1.37|||t-test, 2 sided|p value for 1st year||||1.37|0.68|0.0001
72360009|NCT02732600|144231787|SUPERIORITY||Mean Difference (Final Values)|5.7|STANDARD_ERROR_OF_MEAN|2.26||0.02|TWO_SIDED|95.0|1.46|9.96|||t-test, 2 sided|||||9.96|1.46|0.02
72360010|NCT02732600|144231787|SUPERIORITY||Mean Difference (Final Values)|2.6|STANDARD_ERROR_OF_MEAN|2.92||0.38|TWO_SIDED|95.0|-3.14|8.54|||t-test, 2 sided|||||8.54|-3.14|0.38
72360011|NCT02732600|144231788|SUPERIORITY||Mean Difference (Final Values)|-99.4|STANDARD_ERROR_OF_MEAN|41.73||0.027|TWO_SIDED|95.0|-186.2|-12.66|||t-test, 2 sided|||||-12.66|-186.2|0.027
72360012|NCT02732600|144231789|SUPERIORITY||Mean Difference (Final Values)|0.6|STANDARD_ERROR_OF_MEAN|0.18||0.001|TWO_SIDED|95.0|0.28|0.92|||t-test, 2 sided|||||0.92|0.28|0.001
72360013|NCT00528957|144231793|NON_INFERIORITY_OR_EQUIVALENCE|In the randomized phase, it was assumed that the respective proportions of participants maintaining HIV-1 RNA \< 400 copies/mL was 92% for participants switching to tenofovir DF and 90% for participants continuing stavudine or zidovudine, as estimated from previous GSI studies. The equivalence limit was set at -15% for the lower boundary of a two-sided 95% confidence interval (CI) on the difference in proportions of participants maintaining HIV-1 RNA \< 400 copies/mL at Week 48.|Difference in percentages between groups|-8.5|||||TWO_SIDED|95.0|-21.5|4.5|||Normal approximation|The difference between the two proportions and its CI were based on normal approximation methods.|Difference is for tenofovir DF minus stavudine or zidovudine (randomized phase)|"The statistical hypotheses for the primary endpoint was as follows:~* Null Hypothesis: tenofovir DF group is more than 15% worse than the stavudine or zidovudine group with respect to the proportion of participants maintaining HIV-1 RNA concentrations \< 400 copies/mL at Week 48.~* Alternate Hypothesis: tenofovir DF group is no more than 15% worse than the stavudine or zidovudine group with respect to the proportion of participants maintaining HIV-1 RNA \< 400 copies/mL at Week 48."||4.5|-21.5|
72360014|NCT00528957|144231794|NON_INFERIORITY|In the randomized phase, it was assumed that the respective proportions of participants maintaining HIV-1 RNA \< 400 copies/mL was 92% for subjects switching to tenofovir DF and 90% for subjects continuing stavudine or zidovudine, as estimated from previous GSI studies. The equivalence limit was set at -15% for the lower boundary of a two-sided 95% confidence interval (CI) on the difference in proportions of participants maintaining HIV-1 RNA \< 400 copies/mL at Week 48.|Difference in percentages between groups|-0.9|||||TWO_SIDED|95.0|-13.7|11.8|||||The difference between the two proportions and its CI were based on normal approximation methods.|||11.8|-13.7|
72360015|NCT00771914|144231839|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0|TWO_SIDED|95.0||||The analyses were not adjusted for multiple comparisons.|Wilcoxon (Mann-Whitney)|||The Wilcoxon Signed-Rank Test was used to determine significant differences between the closure time effect (clotting)in seconds from baseline compared to four hours after placebo.||||0.00
72360016|NCT00771914|144231839|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|12.0||||0.31|TWO_SIDED|95.0||||The analyses were not adjusted for multiple comparisons.|Wilcoxon (Mann-Whitney)|||The Wilcoxon Signed-Rank Test was used to determine significant differences between the closure time effect (clotting)in seconds from Aspirin compared to Placebo.||||0.31
72360017|NCT00771914|144231839|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.0||||0.49|TWO_SIDED|95.0||||The analyses were not adjusted for multiple comparisons.|Wilcoxon (Mann-Whitney)|||The Wilcoxon Signed-Rank Test was used to determine significant differences between the closure time effect (clotting)in seconds from Lovaza compared to Placebo.||||0.49
72360018|NCT00771914|144231839|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|30.0||||0.03|TWO_SIDED|95.0||||The analyses were not adjusted for multiple comparisons.|Wilcoxon (Mann-Whitney)|||The Wilcoxon Signed-Rank Test was used to determine significant differences between the closure time effect (clotting)in seconds from both Aspirin and Lovaza compared to Placebo.||||0.03
72360019|NCT03111875|144231857|SUPERIORITY|common effect|Risk Ratio (RR)|1.04||||0.69|TWO_SIDED|95.6|0.87|1.24|||Mixed Models Analysis|||||1.24|0.87|0.69
72360020|NCT03111875|144231857|SUPERIORITY|average relative effect|Risk Ratio (RR)|0.68||||0.1|TWO_SIDED|95.6|0.43|1.08|||Mixed Models Analysis|||||1.08|0.43|0.10
72360021|NCT03111875|144231858|SUPERIORITY||Risk Ratio (RR)|1.13||||0.25|TWO_SIDED|98.75|0.87|1.47|||log-binomial models|The relative risk was estimated using a GEE model to adjust for within-patient correlation across components and log link (to estimate relative risk).||||1.47|0.87|0.25
72360022|NCT03111875|144231859|SUPERIORITY||Risk Ratio (RR)|1.07||||0.41|TWO_SIDED|98.75|0.87|1.33|||log-binomial models|The relative risk was estimated using a GEE model to adjust for within-patient correlation across components and log link (to estimate relative risk)||||1.33|0.87|0.41
72360023|NCT01323582|144231886|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.6|STANDARD_ERROR_OF_MEAN|11.7||0.76|TWO_SIDED|95.0|-21.5|28.6|||t-test, 2 sided|Satterthwaite corrected t-test was used|A positive (negative) value would suggest AZI values would tend to be larger (smaller) than EZ values.|Study planned to accrue 50 subjects, but due to difficult recruitment was not able to meet its objective.||28.6|-21.5|0.76
72360024|NCT01323582|144231887|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.3|STANDARD_ERROR_OF_MEAN|2.8||0.65||95.0|-4.8|7.5|||t-test, 2 sided|Satterthwaite Correction used|A positive (negative) value would suggest AZI values would tend to be larger (smaller) than EZ values.|Study planned to accrue 50 subjects, but due to difficult recruitment was not able to meet its objective.||7.5|-4.8|0.65
72360025|NCT01323582|144231888|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.35|STANDARD_ERROR_OF_MEAN|2.3||0.88|TWO_SIDED|95.0|-4.58|5.19|||t-test, 2 sided|Satterthwaite correction for unequal standard deviations was used|A positive (negative) value would suggest AZI values would tend to be larger (smaller) than EZ values.|Half of the period 2 minus period 1 differences were used, since the difference between these two derived means is an unbiased estimate of the effect size.||5.19|-4.58|0.88
72360026|NCT01323582|144231889|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.49|STANDARD_ERROR_OF_MEAN|5.7||0.8|TWO_SIDED|95.0|-13.9|10.9|||t-test, 2 sided|Satterthwaite Corrected t-test|A positive (negative) value would suggest AZI values would tend to be larger (smaller) than EZ values.|||10.9|-13.9|0.80
72360027|NCT01323582|144231890|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-11.8|STANDARD_ERROR_OF_MEAN|9.1||0.21|TWO_SIDED|95.0|-30.9|7.3|||t-test, 2 sided||Negative values suggest shorter emptying time post-treatment.|||7.3|-30.9|0.21
72360028|NCT01323582|144231891|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-15.0|STANDARD_ERROR_OF_MEAN|6.61||0.034|TWO_SIDED|95.0|-28.7|-1.26|||t-test, 2 sided||Negative values suggest shorter emptying time post-treatment.|||-1.26|-28.7|0.034
72360029|NCT01323582|144231892|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.32|STANDARD_ERROR_OF_MEAN|1.98||0.015|TWO_SIDED|95.0|-9.48|-1.16|||t-test, 2 sided||Lower scores are favorable.|||-1.16|-9.48|0.015
72360030|NCT01323582|144231893|SUPERIORITY_OR_OTHER||Median Difference (Net)|-6.4|STANDARD_ERROR_OF_MEAN|2.2||0.0083|TWO_SIDED|95.0|-10.97|-1.83|||t-test, 2 sided||Lower scores are favorable.|||-1.83|-10.97|0.0083
72360031|NCT00960375|144231908|SUPERIORITY_OR_OTHER|||||||0.489|TWO_SIDED||||||ANOVA|||Smoking reduction outcomes were examined in the randomized sample using data from baseline and post-treatment assessments. The variable examined was self-reported number of cigarettes smoked per day during the last 7 days. This variable was skewed so a natural log transformation was applied before linear mixed model analysis.||||0.489
72360032|NCT00960375|144231909|SUPERIORITY_OR_OTHER|||||||0.685|TWO_SIDED||||||ANOVA|||This outcome was examined in the randomized sample. Abstinence was defined as self-reported no smoking in the last 7 days + expired CO ≤ 10 PPM. To assess difference in change between conditions, we tested the significance of the condition-by-time interaction using repeated measured mixed models with a random participant effect. Time was binary: post-treatment versus baseline. We used a logistic model for binary outcomes.||||0.685
72360033|NCT02051764|144231910|OTHER|||||||0.2837||||||Not adjusted for multiple comparisons. No a priori threshold was selected.|ANCOVA|Adjustments included baseline tau deposition, age, time (in years) between imaging, and included an interaction of time and enrolling diagnosis.||Overall change from baseline between groups. Test compared slopes of cognitively impaired (CI) vs healthy volunteers (HV). As the time between scans varied across subjects, an ANCOVA model was used to estimate slopes in each diagnosis group and test whether they were the different at 1 year. The flortaucipir change from baseline was used as the dependent variable in the model.||||0.2837
72360034|NCT02051764|144231910|OTHER|||||||0.9276||||||Not adjusted for multiple comparisons. No a priori threshold was selected.|ANCOVA|Adjustments included baseline tau deposition, age, time (in years) between imaging, and included an interaction of time and enrolling diagnosis.||Change from baseline between groups for amyloid negative only. Test compared slopes of CI vs HV. As the time between scans varied across subjects, an ANCOVA model was used to estimate slopes in each diagnosis group and test whether they were different at 1 year. The flortaucipir change from baseline was used as the dependent variable in the model.||||0.9276
72360035|NCT02051764|144231910|OTHER|||||||0.6324||||||Not adjusted for multiple comparisons. No a priori threshold was selected.|ANCOVA|Adjustments included baseline tau deposition, age, time (in years) between imaging, and included an interaction of time and enrolling diagnosis.||Change from baseline between groups for amyloid positive only. Test compared slopes of CI vs HV. As the time between scans varied across subjects, an ANCOVA model was used to estimate slopes in each diagnosis group and test whether they were different at 1 year. The flortaucipir change from baseline was used as the dependent variable in the model.||||0.6324
72360036|NCT03155724|144231917|SUPERIORITY||||||<|0.0001|||||||Exact, binomial, one-sided|||The primary endpoint 1 hypothesis was evaluated by performing an exact, binomial test comparing the binomial proportion of 'improved' patients to 3.0% with power of 80% and type 1 error (alpha) of 0.0224. A pre-planned interim analysis at 45 patients required a type 1 error (alpha) of 0.0026 to demonstrate significance.||||<0.0001
72360037|NCT00321789|144231922|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.3||||0.44|TWO_SIDED|95.0|-3.6|8.3|||Mixed Models Analysis|Model was adjusted for a priori race and cardiovascular disease risk level strata.||||8.3|-3.6|0.44
72360038|NCT00321789|144231923|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.12||||0.03|TWO_SIDED|95.0|-0.23|-0.01|||Mixed Models Analysis|Based on log-transformed values. Model was adjusted for a priori race and cardiovascular disease risk level strata.||||-0.01|-0.23|0.03
72360039|NCT00321789|144231924|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.16||||0.02|TWO_SIDED|95.0|-0.29|-0.02|||Mixed Models Analysis|Based on log-transformed values. Model was adjusted for a priori race and cardiovascular disease risk level strata.||||-0.02|-0.29|0.02
72360040|NCT00321789|144231925|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.16||||0.02|TWO_SIDED|95.0|-0.29|-0.03|||Mixed Models Analysis|Based on log-transformed values. Model was adjusted for a priori race and cardiovascular disease risk level strata.||||-0.03|-0.29|0.02
72360041|NCT00321789|144231926|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.13||||0.11|TWO_SIDED|95.0|-0.3|0.03|||Mixed Models Analysis|Based on log-transformed values. Model was adjusted for a priori race and cardiovascular disease risk level strata.||||0.03|-0.30|0.11
72360042|NCT00321789|144231927|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.07||||0.26|TWO_SIDED|95.0|-0.06|0.2|||Mixed Models Analysis|Based on log-transformed values. Model was adjusted for a priori race and cardiovascular disease risk level strata.||||0.20|-0.06|0.26
72360043|NCT00321789|144231928|SUPERIORITY_OR_OTHER||incident rate ratio|1.2||||0.06|TWO_SIDED|95.0|1.0|1.5|||generalized estimating equations|Based on log-transformed values. Model was adjusted for a priori race and cardiovascular disease risk level strata.||||1.5|1.0|0.06
72360044|NCT00321789|144231929|SUPERIORITY_OR_OTHER||incident rate ratio|1.1||||0.37|TWO_SIDED|95.0|0.9|1.4|||generalized estimating equations|Model adjusted for a priori race and cardiovascular disease risk category.||||1.4|0.9|0.37
72360045|NCT00321789|144231930|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.11||||0.04|TWO_SIDED|95.0|-4.13|-0.09|||Mixed Models Analysis|Model adjusted for a priori race and cardiovascular disease risk category.||||-0.09|-4.13|0.04
72360046|NCT00321789|144231931|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.64||||0.09|TWO_SIDED|95.0|-1.38|0.1|||Mixed Models Analysis|Model adjusted for a priori race and cardiovascular disease risk category.||||0.10|-1.38|0.09
72360047|NCT00321789|144231932|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.95||||0.87|TWO_SIDED|95.0|0.6|1.7|||Regression, Logistic|Model adjusted for a priori race and cardiovascular disease risk category.||||1.7|0.6|0.87
72360048|NCT03309020|144231935|OTHER|||||||0.802||||||The threshold for statistical significance was p = 0.05|Mixed Models Analysis|Age at enrollment and gender (male or female) were included as covariates in the model||Null hypothesis is no difference in grade between survivor statuses one month after cataract surgery||||0.802
72360049|NCT03309020|144231936|OTHER|||||||0.713||||||The threshold for statistical significance was p = 0.05|Mixed Models Analysis|Age at enrollment and gender (male or female) were included as covariates in the model||Null hypothesis is no difference in grade between survivor statuses three months after cataract surgery||||.713
72360050|NCT03309020|144231937|OTHER||Odds Ratio (OR)|0.1|||||TWO_SIDED|95.0|0.01|0.69|||||Odds of eye with at least 20/40 best corrected visual acuity (BCVA) 12 months after cataract surgery for controls vs. EVD survivors|Null hypothesis is no difference in the proportion of participants with at least 20/40 best corrected visual acuity (BCVA) between survivor statuses||0.69|0.01|
72360051|NCT03309020|144231938|OTHER|||||||0.832||||||The threshold for statistical significance was p = 0.05|Mixed Models Analysis|Age at enrollment and gender (male or female) were included as covariates in the model||||||.832
72360052|NCT03309020|144231939|OTHER|||||||0.995||||||The threshold for statistical significance was p = 0.05|Mixed Models Analysis|Age at enrollment and gender (male or female) were included as covariates in the model||||||.995
72360053|NCT03309020|144231940|OTHER|||||||0.441||||||The threshold for statistical significance was p = 0.05|Mixed Models Analysis|Age at enrollment and gender (male or female) were included as covariates in the model||||||0.441
72360054|NCT03309020|144231941|OTHER|||||||0.892||||||The threshold for statistical significance was p = 0.05|Mixed Models Analysis|Age at enrollment, survivor status (EVD survivor/control) included as covariates; within-subject measurement of distinct eyes treated as independent||||||.892
72360055|NCT03309020|144231942|OTHER|||||||0.913||||||The threshold for statistical significance was p = 0.05|Mixed Models Analysis|Age at enrollment, survivor status (EVD survivor/control) included as covariates; within-subject measurement of distinct eyes treated as independent||||||.913
72360056|NCT03309020|144231943|OTHER|||||||0.106||||||The threshold for statistical significance was p = 0.05|Mixed Models Analysis|Gender (male/female), survivor status (EVD survivor/control) as covariates; within-subject measurement of distinct eyes treated as independent||||||.106
72360057|NCT03309020|144231944|OTHER|||||||0.09||||||The threshold for statistical significance was p = 0.05|Mixed Models Analysis|Gender (male/female), survivor status (EVD survivor/control) as covariates; within-subject measurement of distinct eyes treated as independent||||||0.09
72360058|NCT02919761|144231950|OTHER||||||=|0.242||||||At Week 4|One-sample binomial test|||||||=0.242
72360059|NCT02919761|144231950|OTHER||||||<|0.0001||||||At Week 8|One-sample binomial test|||||||<0.0001
72360060|NCT02919761|144231950|OTHER||||||<|0.0001|||||||One-sample binomial test|||||||<0.0001
72360061|NCT02919761|144231951|OTHER||||||=|0.313||||||Comparison at Week 12|Pearson's Chi-square test|||||||=0.313
72360062|NCT02919761|144231951|OTHER||||||=|0.439||||||Comparison at Week 16|Pearson's Chi-square test|||||||=0.439
72360063|NCT02919761|144231951|OTHER||||||=|0.028||||||Comparison at Week 20|Pearson's Chi-square test|||||||=0.028
72360064|NCT02919761|144231951|OTHER||||||=|0.019||||||Comparison at Week 24|Pearson's Chi-square test|||||||=0.019
72360065|NCT03349723|144231974|OTHER||Slope|0.9806|STANDARD_ERROR_OF_MEAN|0.0322|||TWO_SIDED|95.0|0.9155|1.0457|||||Based on the estimate for the slope parameter (β), a 2-sided 95% CI for the slope was computed. Perfect dose proportionality would correspond to a slope of 1.|The model consisted of a regression model applied to log-transformed data. The corresponding ANCOVA model included the logarithm of the dose as a covariate.||1.0457|0.9155|
72360066|NCT03349723|144231975|OTHER||Slope|0.9892|STANDARD_ERROR_OF_MEAN|0.0339|||TWO_SIDED|95.0|0.9207|1.0577|||||Based on the estimate for the slope parameter (β), a 2-sided 95% CI for the slope was computed. Perfect dose proportionality would correspond to a slope of 1.|The model consisted of a regression model applied to log-transformed data. The corresponding ANCOVA model included the logarithm of the dose as a covariate.||1.0577|0.9207|
72360067|NCT02973100|144231985|SUPERIORITY||Mean Difference (Final Values)|-0.8|||<|0.001|TWO_SIDED|95.0|-1.07|-0.53|||Mixed Models Analysis|||||-0.53|-1.07|<.001
72360068|NCT02973100|144231985|SUPERIORITY||Mean Difference (Final Values)|-0.87|||<|0.001|TWO_SIDED|95.0|-1.14|-0.6|||Mixed Models Analysis|||||-0.60|-1.14|<0.001
72360069|NCT02973100|144231985|SUPERIORITY||Mean Difference (Final Values)|-0.96|||<|0.001|TWO_SIDED|95.0|-1.24|-0.69|||Mixed Models Analysis|||||-0.69|-1.24|<.001
72360070|NCT02973100|144231986|SUPERIORITY||Odds Ratio (OR)|24.489|||<|0.001|TWO_SIDED|95.0|8.368|71.667|||Regression, Logistic|||||71.667|8.368|<.001
72360071|NCT02973100|144231986|SUPERIORITY||Odds Ratio (OR)|27.906|||<|0.001|TWO_SIDED|95.0|9.238|84.3|||Regression, Logistic|||||84.300|9.238|<.001
72360072|NCT02973100|144231986|SUPERIORITY||Odds Ratio (OR)|21.852|||<|0.001|TWO_SIDED|95.0|7.672|62.242|||Regression, Logistic|||||62.242|7.672|<.001
72360073|NCT02973100|144231987|SUPERIORITY||Mean Difference (Final Values)|-1.32|||<|0.001|TWO_SIDED|95.0|-2.02|-0.62|||Mixed Models Analysis|||||-0.62|-2.02|<0.001
72360074|NCT02973100|144231987|SUPERIORITY||Mean Difference (Final Values)|-1.23|||<|0.001|TWO_SIDED|95.0|-1.91|-0.54|||Mixed Models Analysis|||||-0.54|-1.91|<0.001
72360075|NCT02973100|144231987|SUPERIORITY||Mean Difference (Final Values)|-1.42|||<|0.001|TWO_SIDED|95.0|-2.12|-0.72|||Mixed Models Analysis|||||-0.72|-2.12|<0.001
72360076|NCT02973100|144231988|SUPERIORITY||Mean Difference (Final Values)|-1.2||||0.025|TWO_SIDED|95.0|-2.3|-0.2|||Mixed Models Analysis|||||-0.2|-2.3|0.025
72360077|NCT02973100|144231988|SUPERIORITY||Mean Difference (Final Values)|-2.4|||<|0.001|TWO_SIDED|95.0|-3.4|-1.3|||Mixed Models Analysis|||||-1.3|-3.4|<0.001
72360078|NCT02973100|144231988|SUPERIORITY||Mean Difference (Final Values)|-2.6|||<|0.001|TWO_SIDED|95.0|-3.7|-1.5|||Mixed Models Analysis|||||-1.5|-3.7|<0.001
72360079|NCT00960622|144232007|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.6|STANDARD_DEVIATION|8.5|<|0.05|TWO_SIDED|95.0|-6.3|11.3|||t-test, 2 sided|||"Paired t-tests for inter-group differences between baseline and end-of-study measurements.Regression analysis, physiological correlates of statistically significant between-group changes.~P\<0.05 chosen for statistical significance"||11.3|-6.3|<0.05
72360080|NCT01959503|144232014|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Rank-Sum Test|||||||<0.0001
72360081|NCT01959503|144232015|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|9.0|||<|0.0001|TWO_SIDED|95.0|4.07|19.89|||Regression, Logistic|||||19.89|4.07|<0.0001
72360082|NCT01959503|144232016|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|7.69|||<|0.0001|TWO_SIDED|95.0|3.27|18.11|||Regression, Logistic|||||18.11|3.27|<0.0001
72360083|NCT01600326|144232022|OTHER|Pair-wise comparison at Time point 1 compared to baseline|||||<|0.0001||||||One way repeated measure analysis of variance for outcome of total pain score over time adjusted for treatment with post hoc Tukey correction to adjust for multiple comparison|Tukey|See comments on P value||||||<0.0001
72360084|NCT01600326|144232022|SUPERIORITY||||||<|0.0001||||||One way repeated measure analysis of variance for outcome of total pain score over time adjusted for treatment with post hoc Tukey correction to adjust for multiple comparison|Tukey|||One way repeated measure analysis of variance for outcome of total pain score over time adjusted for treatment with post hoc Tukey correction to adjust for multiple comparison||||<0.0001
72360085|NCT01600326|144232023|SUPERIORITY||||||>|0.99|||||||Fisher Exact|||||||>.99
72360086|NCT03224130|144232024|SUPERIORITY|||||||0.21|||||||Regression, Logistic|||||||0.21
72360087|NCT03224130|144232025|SUPERIORITY|||||||0.31|||||||Regression, Linear|||||||0.31
72360088|NCT03224130|144232026|SUPERIORITY|||||||0.24|||||||censored Poisson model|||||||0.24
72360089|NCT03224130|144232027|SUPERIORITY||||||<|0.01|||||||Poisson model|||||||<0.01
72360090|NCT03224130|144232028|SUPERIORITY|||||||0.5|||||||Regression, Logistic|||||||0.50
72360091|NCT03224130|144232029|SUPERIORITY|||||||0.998|||||||Regression, Logistic|||||||0.998
72360092|NCT03224130|144232030|SUPERIORITY|||||||0.92|||||||Regression, Logistic|||||||0.92
72360093|NCT00072462|144232090|SUPERIORITY||Hazard Ratio (HR)|0.88|STANDARD_DEVIATION|0.12||0.33|TWO_SIDED|95.0|0.67|1.14|||Regression, Cox|Univariate||||1.14|0.67|0.33
72360094|NCT00072462|144232090|SUPERIORITY||Hazard Ratio (HR)|0.87|STANDARD_DEVIATION|0.12||0.33|TWO_SIDED|95.0|0.66|1.15|||Regression, Cox|Covariates included in model: Hormone Replacement Therapy use, Age, BMI, Use of radiotherapy, Extent of margins, Grade(categorical: low, medium, high)||||1.15|0.66|0.33
72360095|NCT00072462|144232091|SUPERIORITY||Hazard Ratio (HR)|0.72|STANDARD_DEVIATION|0.12||0.06|TWO_SIDED|95.0|0.52|1.01|||Regression, Cox|Univariate||||1.01|0.52|0.06
72360096|NCT00072462|144232091|SUPERIORITY||Hazard Ratio (HR)|0.74|STANDARD_DEVIATION|0.13||0.09|TWO_SIDED|95.0|0.52|1.05|||Regression, Cox|Covariates included in model: Hormone Replacement Therapy use, Age, BMI, Use of radiotherapy, Extent of margins, Grade(categorical: low, medium, high)||||1.05|0.52|0.09
72360097|NCT00072462|144232092|SUPERIORITY||Hazard Ratio (HR)|1.64|STANDARD_DEVIATION|0.54||0.13|TWO_SIDED|95.0|0.75|2.84|||Regression, Cox|Univariate||||2.84|0.75|0.13
72360098|NCT00072462|144232092|SUPERIORITY||Hazard Ratio (HR)|1.46|STANDARD_DEVIATION|0.5||0.26|TWO_SIDED|95.0|0.75|2.84|||Regression, Cox|Covariates included in model: Hormone Replacement Therapy use, Age, BMI, Use of radiotherapy, Extent of margins, Grade(categorical: low, medium, high)||||2.84|0.75|0.26
72360099|NCT00072462|144232093|SUPERIORITY||Hazard Ratio (HR)|1.03||||0.97|TWO_SIDED|95.0|0.21|5.11|||Regression, Cox|Univariate||||5.11|0.21|0.97
72360100|NCT00072462|144232093|SUPERIORITY||Hazard Ratio (HR)|1.08|STANDARD_DEVIATION|0.88||0.93|TWO_SIDED|95.0|0.22|5.36|||Regression, Cox|Covariates included in model: Hormone Replacement Therapy use, Age, BMI, Use of radiotherapy, Extent of margins, Grade(categorical: low, medium, high)||||5.36|0.22|0.93
72360101|NCT00072462|144232094|SUPERIORITY||Hazard Ratio (HR)|0.93|STANDARD_DEVIATION|0.17||0.67|TWO_SIDED|95.0|0.65|1.32|||Regression, Cox|Univariate||||1.32|0.65|0.67
72360102|NCT00072462|144232094|SUPERIORITY||Hazard Ratio (HR)|0.85|STANDARD_DEVIATION|0.16||0.38|TWO_SIDED|95.0|0.59|1.22|||Regression, Cox|Covariates included in model: Hormone Replacement Therapy use, Age, BMI, Use of radiotherapy, Extent of margins, Grade(categorical: low, medium, high)||||1.22|0.59|0.38
72360103|NCT02927301|144232101|SUPERIORITY||Other/Percentage|20.3|||<|0.0001|ONE_SIDED|95.0|14.9||||binomial test||||||14.900|<.0001
72360104|NCT02927301|144232102|SUPERIORITY||Risk Difference (RD)|11.41||||0.0358|ONE_SIDED|80.0|5.279||||Fisher Exact||||||5.279|0.0358
72360105|NCT02927301|144232103|SUPERIORITY||Risk Difference (RD)|16.363||||0.0395|ONE_SIDED|80.0|6.509||||Chi-squared||||||6.509|0.0395
72360106|NCT03562195|144232130|SUPERIORITY||Posterior probablity|0.9999|||||||||||Bayesian Dynamic Borrowing|A BDB approach was used in the estimation of primary endpoint in the Chinese participants of this study, with information borrowed from MEA115588.|"Pr (rate ratio \<1 \| data)\>0.999. The 'positive result' is defined as if the posterior probability that the rate ratio is less than 1 is at least 0.95"|||||
72360107|NCT03562195|144232130|SUPERIORITY|The null hypothesis is defined as the rate ratio of events between Mepolizumab 100mg SC versus placebo is less than 1.|Rate Ratio|0.35|||<|0.001|TWO_SIDED|95.0|0.24|0.5|||Negative binomial model|||||0.50|0.24|<0.001
72360108|NCT04664153|144232149|SUPERIORITY||Mean Difference (Final Values)|-39.4|STANDARD_ERROR_OF_MEAN|11.74||0.0004|TWO_SIDED|90.0|-58.76|-20.12|||t-test, 1 sided|||||-20.12|-58.76|0.0004
72360109|NCT04664153|144232150|SUPERIORITY||Mean Difference (Final Values)|-4.9|STANDARD_ERROR_OF_MEAN|1.29|<|0.0001|TWO_SIDED|90.0|-7.02|-2.77|||t-test, 1 sided|||||-2.77|-7.02|<0.0001
72360110|NCT00097500|144232168|SUPERIORITY_OR_OTHER|||||||0.0001||95.0|||||ANCOVA|||||||0.0001
72360111|NCT00097500|144232169|SUPERIORITY_OR_OTHER|||||||0.4185||95.0|||||ANCOVA|||||||0.4185
72360112|NCT00097500|144232170|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||Statistical analysis at week 52.||||<0.0001
72360113|NCT00097500|144232170|SUPERIORITY_OR_OTHER|||||||0.1188||95.0|||||ANCOVA|||Statistical analysis at week 56.||||0.1188
72360114|NCT00097500|144232171|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||Statistical analysis at week 52.||||<0.0001
72360115|NCT00097500|144232171|SUPERIORITY_OR_OTHER|||||||0.1996||95.0|||||ANCOVA|||Statistical analysis at week 56.||||0.1996
72360116|NCT00097500|144232172|SUPERIORITY_OR_OTHER|||||||0.5522||95.0|||||ANCOVA|||||||0.5522
72360117|NCT00097500|144232173|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||||||<0.0001
72360118|NCT00097500|144232175|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||||||<0.0001
72360119|NCT00189098|144232193|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-25.0|||||TWO_SIDED|95.0|-44.0|-6.0|||risk differences (RD)||Risk difference and 95% confidence intervals reported for 6 weeks follow-up.|"Assuming a spontaneous recovery of 25% and a treatment effect of TMP-SMX of 50% (based on a retrospective study of children treated with TMP-SMX for COM at our hospital), and taking α=0.05 and a power of 0.80, we calculated that each group should consist of 50 children.~Rate differences with 95% confidence intervals were calculated at the three control visits to compare both groups for the outcome measures."||-6|-44|
72360120|NCT00189098|144232193|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-15.0|||||TWO_SIDED|95.0|-34.0|4.0|||risk difference (RD)||Risk difference and confidence interval reported for 12 week follow-up|"Assuming a spontaneous recovery of 25% and a treatment effect of TMP-SMX of 50% (based on a retrospective study of children treated with TMP-SMX for COM at our hospital), and taking α=0.05 and a power of 0.80, we calculated that each group should consist of 50 children.~Rate differences with 95% confidence intervals were calculated at the three control visits to compare both groups for the outcome measures."||4|-34|
72360121|NCT00189098|144232193|SUPERIORITY_OR_OTHER||Risk Difference (RD)|5.0|||||TWO_SIDED|95.0|-12.0|22.0|||risk difference (RD)||Risk difference and confidence interval reported for 1 year follow-up.|"Assuming a spontaneous recovery of 25% and a treatment effect of TMP-SMX of 50% (based on a retrospective study of children treated with TMP-SMX for COM at our hospital), and taking α=0.05 and a power of 0.80, we calculated that each group should consist of 50 children.~Rate differences with 95% confidence intervals were calculated at the three control visits to compare both groups for the outcome measures."||22|-12|
72360122|NCT00189098|144232194|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-12.0|||||TWO_SIDED|95.0|-34.0|10.0|||rate differences (95%CI intervals)||Risk difference and confidence interval reported for eardrop usage between 6 and 12 weeks follow-up.|||10|-34|
72360123|NCT00189098|144232195|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-4.0|||||TWO_SIDED|95.0|-22.0|14.0|||rate difference (RD)||Risk difference and confidence interval reported for eardrop usage between 12 weeks and 1 year follow-up.|||14|-22|
72360124|NCT00189098|144232196|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-7.0|||||TWO_SIDED|95.0|-23.0|9.0|||Rate differences (95%CI interval)||Risk difference and confidence interval reported for the use of additional systemic antibiotics other than the study medication between 6 to 12 weeks follow-up.|||9|-23|
72360125|NCT00189098|144232197|SUPERIORITY_OR_OTHER||Risk Difference (RD)|15.0|||||TWO_SIDED|95.0|-7.0|37.0|||Rate difference (RD)||Risk difference and confidence interval reported for the use of additional systemic antibiotics other than the study medication between 12 weeks and 1 year follow-up.|||37|-7|
72360126|NCT00189098|144232198|SUPERIORITY_OR_OTHER||Risk Difference (RD)|6.0|||||TWO_SIDED|95.0|-12.0|24.0|||Rate differences (95%CI intervals)||Risk difference and confidence interval reported for participants who underwent Ear Nose and Throat Surgery between 12 weeks and 1 year follow-up.|||24|-12|
72360127|NCT00474123|144232199|SUPERIORITY_OR_OTHER|||||||0.3||95.0|||||Wilcoxon (Mann-Whitney)|||The sample size was determined as 78 patients. Continuous data were presented as means ± SD, or median (interquartile range) when the distribution was non-normal. For qualitative variables, we presented counts and relative frequencies. For between-group comparison we used multiple regression with adjustment for baseline values of the outcome variable (ANCOVA), or Wilcoxon rank-sum test when the variable had a non-normal distribution.||||0.3
72360128|NCT00474123|144232200|SUPERIORITY_OR_OTHER|||||||0.65||95.0|||||ANCOVA|||The sample size was determined as 78 patients. Continuous data were presented as means ± SD, or median (interquartile range) when the distribution was non-normal. For qualitative variables, we presented counts and relative frequencies. For between-group comparison we used multiple regression with adjustment for baseline values of the outcome variable (ANCOVA), or Wilcoxon rank-sum test when the variable had a non-normal distribution.||||0.65
72360129|NCT00474123|144232201|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||ANCOVA|||The sample size was determined as 78 patients. Continuous data were presented as means ± SD, or median (interquartile range) when the distribution was non-normal. For qualitative variables, we presented counts and relative frequencies. For between-group comparison we used multiple regression with adjustment for baseline values of the outcome variable (ANCOVA), or Wilcoxon rank-sum test when the variable had a non-normal distribution.||||0.02
72360130|NCT00474123|144232202|SUPERIORITY_OR_OTHER|||||||0.85||95.0|||||ANCOVA|||The sample size was determined as 78 patients. Continuous data were presented as means ± SD, or median (interquartile range) when the distribution was non-normal. For qualitative variables, we presented counts and relative frequencies. For between-group comparison we used multiple regression with adjustment for baseline values of the outcome variable (ANCOVA), or Wilcoxon rank-sum test when the variable had a non-normal distribution.||||0.85
72360131|NCT01009060|144232211|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.049||||0.7239|TWO_SIDED|90.0|-0.288|0.19|||Mixed Model Repeated Measure|||Week 1||0.190|-0.288|0.7239
72360132|NCT01009060|144232211|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.018||||0.8351|TWO_SIDED|90.0|-0.127|0.163|||Mixed Model Repeated Measure|||Week 2||0.163|-0.127|0.8351
72360133|NCT01009060|144232211|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.088||||0.4541|TWO_SIDED|90.0|-0.287|0.11|||Mixed Model Repeated Measure|||Week 3||0.110|-0.287|0.4541
72360134|NCT01009060|144232211|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.089||||0.4148|TWO_SIDED|90.0|-0.272|0.093|||Mixed Model Repeated Measure|||Week 4||0.093|-0.272|0.4148
72360135|NCT01009060|144232211|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.086||||0.3887|TWO_SIDED|90.0|-0.082|0.254|||Mixed Model Repeated Measure|||Week 5||0.254|-0.082|0.3887
72360136|NCT01009060|144232211|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.195||||0.2594|TWO_SIDED|90.0|-0.093|0.484|||Mixed Model Repeated Measure|||Week 6||0.484|-0.093|0.2594
72360137|NCT01009060|144232211|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.103||||0.4778|TWO_SIDED|90.0|-0.139|0.344|||Mixed Model Repeated Measure|||Week 7||0.344|-0.139|0.4778
72360138|NCT01009060|144232212|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.737||||0.6947|TWO_SIDED|90.0|-3.884|2.409|||ANCOVA|||||2.409|-3.884|0.6947
72360139|NCT01009060|144232213|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.252||||0.1399|TWO_SIDED|90.0|-0.535|0.03|||Mixed Model Repeated Measure||For Speed of Processing/Simple Reaction Time|||0.030|-0.535|0.1399
72360140|NCT01009060|144232213|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.179||||0.3992|TWO_SIDED|90.0|-0.176|0.534|||Mixed Model Repeated Measure||For Attention/Vigilance|||0.534|-0.176|0.3992
72360141|NCT01009060|144232213|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.391||||0.1547|TWO_SIDED|90.0|-0.063|0.845|||Mixed Model Repeated Measure||For Working Memory|||0.845|-0.063|0.1547
72360142|NCT01009060|144232213|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.279||||0.2531|TWO_SIDED|90.0|-0.127|0.685|||Mixed Model Repeated Measure||For Visual Learning|||0.685|-0.127|0.2531
72360143|NCT01009060|144232213|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.398||||0.2417|TWO_SIDED|90.0|-0.167|0.963|||Mixed Model Repeated Measure||For Verbal Learning|||0.963|-0.167|0.2417
72360144|NCT01009060|144232213|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.177||||0.2069|TWO_SIDED|90.0|-0.055|0.409|||Mixed Model Repeated Measure||For Reasoning/Problem Solving|||0.409|-0.055|0.2069
72360145|NCT01009060|144232213|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.03||||0.8645|TWO_SIDED|90.0|-0.262|0.322|||Mixed Model Repeated Measure||For Social Cognition|||0.322|-0.262|0.8645
72360146|NCT01009060|144232213|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.069||||0.7873|TWO_SIDED|90.0|-0.364|0.503|||Mixed Model Repeated Measure||For Working Memory (Two-Back Memory)|||0.503|-0.364|0.7873
72360147|NCT01009060|144232214|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.024||||0.0225|TWO_SIDED|90.0|-6.872|-1.175|||ANCOVA||For Speed of Processing|||-1.175|-6.872|0.0225
72360148|NCT01009060|144232214|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.24||||0.3317|TWO_SIDED|95.0|-6.085|1.605|||ANCOVA||For Attention/Vigilance|||1.605|-6.085|0.3317
72360149|NCT01009060|144232214|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.038||||0.3243|TWO_SIDED|90.0|-5.482|1.406|||ANCOVA||For Working Memory|||1.406|-5.482|0.3243
72360150|NCT01009060|144232214|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.746||||0.7497|TWO_SIDED|90.0|-4.667|3.175|||ANCOVA||For Visual Learning|||3.175|-4.667|0.7497
72360151|NCT01009060|144232214|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.112||||0.1585|TWO_SIDED|90.0|-0.537|6.761|||ANCOVA||For Verbal Learning|||6.761|-0.537|0.1585
72360152|NCT01009060|144232214|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.972||||0.6582|TWO_SIDED|90.0|-2.709|4.654|||ANCOVA||For Reasoning and Problem Solving|||4.654|-2.709|0.6582
72360153|NCT01009060|144232214|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.338||||0.9092|TWO_SIDED|90.0|-5.316|4.639|||ANCOVA||For Social Cognition|||4.639|-5.316|0.9092
72360154|NCT01009060|144232215|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.024||||0.4406|TWO_SIDED|90.0|-3.237|1.19|||Mixed Model Repeated Measure|||||1.190|-3.237|0.4406
72360155|NCT01009060|144232216|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.876||||0.5197|TWO_SIDED|90.0|-6.743|2.99|||Mixed Model Repeated Measure|||||2.990|-6.743|0.5197
72360156|NCT01009060|144232217|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.824||||0.4637|TWO_SIDED|90.0|-2.334|5.982|||Mixed Model Repeated Measure|||||5.982|-2.334|0.4637
72360157|NCT00119847|144232229|SUPERIORITY||Mean Difference (Net)|-0.04||||0.34|TWO_SIDED|95.0|-0.12|0.04||p\<0.05 required for statistical significance|t-test, 2 sided|||The planned sample size of 300 subjects was chosen to provide 80% power to detect a clinically relevant difference of 0.1 in the change in α1 from baseline to 1 year between the 2 treatment groups on the basis of data from prior studies that indicated that baseline levels of α1 would be 1.0 with a common SD of 0.2.||0.04|-0.12|0.34
72360158|NCT00119847|144232230|SUPERIORITY||Mean Difference (Net)|3.0||||0.45|TWO_SIDED|95.0|-4.8|10.7||p\<0.01 required for statistical significance|t-test, 2 sided|||||10.7|-4.8|0.45
72360159|NCT00119847|144232231|SUPERIORITY||Mean Difference (Net)|2.2||||0.23|TWO_SIDED|95.0|-1.4|5.9||p\<0.01 required for statistical significance|t-test, 2 sided|||||5.9|-1.4|0.23
72360160|NCT00265564|144232237|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|||||||Mixed Models Analysis|||We investigated treatment condition differences in change of drug and alcohol use over four time-points using generalized linear mixed modeling analyses. A trajectory for each participant was modeled yielding estimates of baseline scores (intercept), slope, and error. Four between-person parameters were estimated: average baseline score for all participants, average slope over time in TAU condition, effect of being in SS on average intercept, effect of being in SS on average slope.||||> .05
72360161|NCT00265564|144232238|SUPERIORITY||||||<|0.05|||||||Mixed Models Analysis|||||||<.05
72360162|NCT00265564|144232239|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|||||||Mixed Models Analysis|||Generalized linear mixed modeling analysis||||>.05
72360163|NCT00286442|144232240|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5|||<|0.001|TWO_SIDED|95.0|-0.68|-0.32||A step-down strategy was used for the primary analysis. First, the 25mg dose was compared to placebo at the 2-sided 0.05 significance level. The 12.5 mg dose was compared to placebo only if the comparison of the 25mg dose to placebo was significant.|ANCOVA|Analysis of covariance (ANCOVA) with treatment and geographic region as class variables and baseline metformin dose and baseline HbA1c as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|Null Hypothesis: No difference between treatment and placebo arms in change from baseline in glycosylated hemoglobin at wk 26. Sample size calculated based on normally distributed means. For comparison of either dose vs. placebo (2-sample t-test), study sample size \>=500 participants had 95% power to detect a treatment difference as small as 0.4% in the supportive per protocol analysis set assuming SD=0.8%, 2-sided \>0.05 significance level and \>=80% of participants meeting per protocol criteria.||-0.32|-0.68|<0.001
72360164|NCT00286442|144232240|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.48|||<|0.001|TWO_SIDED|95.0|-0.67|-0.3||A step-down strategy was used for the primary analysis. First, the 25mg dose was compared to placebo at the 2-sided 0.05 significance level. The 12.5 mg dose was compared to placebo only if the comparison of the 25mg dose to placebo was significant.|ANCOVA|ANCOVA on change from baseline with treatment and geographic region as class variables and baseline metformin dose and baseline HbA1c as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|Null Hypothesis: No difference between treatment and placebo arms in change from baseline in glycosylated hemoglobin at week 26. Sample size calculated based on normally distributed means. For comparison of either dose vs. placebo (2-sample t-test), study sample size \>=500 participants had 95% power to detect a treatment difference as small as 0.4% in the per protocol analysis set assuming SD=0.8%, 2-sided test at 0.05 significance level and \>=80% of participants meeting per protocol criteria.||-0.30|-0.67|<0.001
72360165|NCT00286442|144232241|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.26|||<|0.001|TWO_SIDED|95.0|-0.37|-0.16||No multiplicity adjustments.|ANCOVA|ANCOVA on change from baseline with treatment and geographic region as class variables and baseline metformin dose and baseline HbA1c as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.16|-0.37|<0.001
72360166|NCT00286442|144232241|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|||<|0.001|TWO_SIDED|95.0|-0.4|-0.19||No multiplicity adjustments.|ANCOVA|ANCOVA on change from baseline with treatment and geographic region as class variables and baseline metformin dose and baseline HbA1c as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.19|-0.40|<0.001
72360167|NCT00286442|144232242|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.38|||<|0.001|TWO_SIDED|95.0|-0.52|-0.24||No multiplicity adjustments.|ANCOVA|ANCOVA on change from baseline with treatment and geographic region as class variables and baseline metformin dose and baseline HbA1c as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.24|-0.52|<0.001
72360168|NCT00286442|144232242|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.38|||<|0.001|TWO_SIDED|95.0|-0.52|-0.24||No multiplicity adjustments.|ANCOVA|ANCOVA on change from baseline with treatment and geographic region as class variables and baseline metformin dose and baseline HbA1c as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.24|-0.52|<0.001
72360169|NCT00286442|144232243|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5|||<|0.001|TWO_SIDED|95.0|-0.66|-0.34||No multiplicity adjustments.|ANCOVA|ANCOVA on change from baseline with treatment and geographic region as class variables and baseline metformin dose and baseline HbA1c as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.34|-0.66|<0.001
72360170|NCT00286442|144232243|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5|||<|0.001|TWO_SIDED|95.0|-0.66|-0.34||No multiplicity adjustments|ANCOVA|ANCOVA on change from baseline with treatment and geographic region as class variables and baseline metformin dose and baseline HbA1c as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.34|-0.66|<0.001
72360171|NCT00286442|144232244|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.53|||<|0.001|TWO_SIDED|95.0|-0.7|-0.36||No multiplicity adjustments.|ANCOVA|ANCOVA on change from baseline with treatment and geographic region as class variables and baseline metformin dose and baseline HbA1c as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.36|-0.70|<0.001
72360172|NCT00286442|144232244|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.51|||<|0.001|TWO_SIDED|95.0|-0.69|-0.34||No multiplicity adjustments.|ANCOVA|ANCOVA on change from baseline with treatment and geographic region as class variables and baseline metformin dose and baseline HbA1c as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.34|-0.69|<0.001
72360173|NCT00286442|144232245|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.52|||<|0.001|TWO_SIDED|95.0|-0.69|-0.34||No multiplicity adjustments.|ANCOVA|ANCOVA on change from baseline with treatment and geographic region as class variables and baseline metformin dose and baseline HbA1c as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.34|-0.69|<0.001
72360174|NCT00286442|144232245|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.52|||<|0.001|TWO_SIDED|95.0|-0.69|-0.34||No multiplicity adjustments.|ANCOVA|ANCOVA on change from baseline with treatment and geographic region as class variables and baseline metformin dose and baseline HbA1c as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.34|-0.69|<0.001
72360175|NCT00286442|144232246|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.7|||<|0.001|TWO_SIDED|95.0|-20.7|-6.8||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline FPG as covariates. Missing data imputed with LOCF.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the metformin arm.|||-6.8|-20.7|<0.001
72360176|NCT00286442|144232246|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.9|||<|0.001|TWO_SIDED|95.0|-18.9|-4.9||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline FPG as covariates. Missing data imputed with LOCF.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the metformin arm.|||-4.9|-18.9|<0.001
72360177|NCT00286442|144232247|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.7|||<|0.001|TWO_SIDED|95.0|-23.9|-9.5||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline FPG as covariates. Missing data imputed with LOCF.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-9.5|-23.9|<0.001
72360178|NCT00286442|144232247|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.8|||<|0.001|TWO_SIDED|95.0|-24.1|-9.6||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline FPG as covariates. Missing data imputed with LOCF.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-9.6|-24.1|<0.001
72360179|NCT00286442|144232248|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.8|||<|0.001|TWO_SIDED|95.0|-24.6|-11.0||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline FPG as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-11.0|-24.6|<0.001
72360180|NCT00286442|144232248|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.5|||<|0.001|TWO_SIDED|95.0|-24.3|-10.6||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline FPG as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-10.6|-24.3|<0.001
72360181|NCT00286442|144232249|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-20.1|||<|0.001|TWO_SIDED|95.0|-28.0|-12.2||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline FPG as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-12.2|-28.0|<0.001
72360182|NCT00286442|144232249|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.6|||<|0.001|TWO_SIDED|95.0|-25.6|-9.7||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline FPG as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-9.7|-25.6|<0.001
72360183|NCT00286442|144232250|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.2|||<|0.001|TWO_SIDED|95.0|-25.6|-8.9||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline FPG as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-8.9|-25.6|<0.001
72360184|NCT00286442|144232250|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.0|||<|0.001|TWO_SIDED|95.0|-25.4|-8.6||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline FPG as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-8.6|-25.4|<0.001
72360185|NCT00286442|144232251|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.1|||<|0.001|TWO_SIDED|95.0|-27.4|-10.8||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline FPG as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-10.8|-27.4|<0.001
72360186|NCT00286442|144232251|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.7|||<|0.001|TWO_SIDED|95.0|-25.0|-8.3||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline FPG as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-8.3|-25.0|<0.001
72360187|NCT00286442|144232252|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-18.1|||<|0.001|TWO_SIDED|95.0|-26.7|-9.4||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline FPG as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-9.4|-26.7|<0.001
72360188|NCT00286442|144232252|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.5|||<|0.001|TWO_SIDED|95.0|-24.2|-6.8||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline FPG as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-6.8|-24.2|<0.001
72360189|NCT00286442|144232253|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-18.7|||<|0.001|TWO_SIDED|95.0|-27.3|-10.2||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline FPG as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-10.2|-27.3|<0.001
72360190|NCT00286442|144232253|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.4|||<|0.001|TWO_SIDED|95.0|-25.9|-8.8||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline FPG as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-8.8|-25.9|<0.001
72360191|NCT00286442|144232254|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.372|||<|0.001|TWO_SIDED|95.0|0.213|0.65||no multiplicity adjustments.|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline metformin dose and baseline HbA1c.|Odd's Ratio (OR) is alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||0.650|0.213|<0.001
72360192|NCT00286442|144232254|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.405||||0.002|TWO_SIDED|95.0|0.231|0.708||No multiplicity adjustments.|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline metformin dose and baseline HbA1c.|Odd's Ratio (OR) is alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||0.708|0.231|0.002
72360193|NCT00286442|144232255|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.302||||0.002|TWO_SIDED|95.0|0.143|0.635||no multiplicity adjustments.|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline metformin dose and baseline HbA1c.|Odd's Ratio (OR) is alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||0.635|0.143|0.002
72360194|NCT00286442|144232255|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.236|||<|0.001|TWO_SIDED|95.0|0.109|0.51|||Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline metformin dose and baseline HbA1c.|Odd's Ratio (OR) is alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||0.510|0.109|<0.001
72360195|NCT00286442|144232256|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.4||||0.634|TWO_SIDED|95.0|-7.4|4.5||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline proinsulin as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||4.5|-7.4|0.634
72360196|NCT00286442|144232256|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.5||||0.136|TWO_SIDED|95.0|-10.5|1.4||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline proinsulin as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||1.4|-10.5|0.136
72360197|NCT00286442|144232257|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.5||||0.274|TWO_SIDED|95.0|-6.9|2.0||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline proinsulin as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||2.0|-6.9|0.274
72360198|NCT00286442|144232257|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.6||||0.046|TWO_SIDED|95.0|-9.1|-0.1||No multiplicity adjustments.|ANCOVA||Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.1|-9.1|0.046
72360199|NCT00286442|144232258|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.4||||0.655|TWO_SIDED|95.0|-7.4|4.6||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline proinsulin as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||4.6|-7.4|0.655
72360200|NCT00286442|144232258|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.4||||0.645|TWO_SIDED|95.0|-7.4|4.6||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline FPG as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||4.6|-7.4|0.645
72360201|NCT00286442|144232259|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9||||0.748|TWO_SIDED|95.0|-6.3|4.6||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline proinsulin as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||4.6|-6.3|0.748
72360202|NCT00286442|144232259|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.2||||0.432|TWO_SIDED|95.0|-7.7|3.3||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline proinsulin as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||3.3|-7.7|0.432
72360203|NCT00286442|144232260|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.2||||0.427|TWO_SIDED|95.0|-7.8|3.3||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline proinsulin as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||3.3|-7.8|0.427
72360204|NCT00286442|144232260|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.9||||0.746|TWO_SIDED|95.0|-4.6|6.5||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline proinsulin as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||6.5|-4.6|0.746
72360205|NCT00286442|144232261|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.1||||0.727|TWO_SIDED|95.0|-5.0|7.2||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline proinsulin as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||7.2|-5.0|0.727
72360206|NCT00286442|144232261|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.601||||1.6|TWO_SIDED|95.0|-4.5|7.8||No multiplicity adjustments|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline proinsulin as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||7.8|-4.5|1.6
72360207|NCT00286442|144232262|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.19||||0.066|TWO_SIDED|95.0|-0.15|4.52||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline insulin as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||4.52|-0.15|0.066
72360208|NCT00286442|144232262|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.6||||0.18|TWO_SIDED|95.0|-0.74|3.93||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline insulin as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||3.93|-0.74|0.180
72360209|NCT00286442|144232263|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.17||||0.944|TWO_SIDED|95.0|-5.02|4.68||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline insulin as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||4.68|-5.02|0.944
72360210|NCT00286442|144232263|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.5||||0.316|TWO_SIDED|95.0|-7.4|2.4||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline insulin as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||2.40|-7.40|0.316
72360211|NCT00286442|144232264|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.32||||0.901|TWO_SIDED|95.0|-5.42|4.77||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline insulin as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||4.77|-5.42|0.901
72360212|NCT00286442|144232264|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.45||||0.578|TWO_SIDED|95.0|-6.59|3.68||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline insulin as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||3.68|-6.59|0.578
72360213|NCT00286442|144232265|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.63||||0.708|TWO_SIDED|95.0|-2.67|3.93||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline insulin as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||3.93|-2.67|0.708
72360214|NCT00286442|144232265|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.89||||0.601|TWO_SIDED|95.0|-2.44|4.21||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline insulin as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||4.21|-2.44|0.601
72360215|NCT00286442|144232266|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.12||||0.398|TWO_SIDED|95.0|-1.48|3.72||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline insulin as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||3.72|-1.48|0.398
72360216|NCT00286442|144232266|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.07||||0.425|TWO_SIDED|95.0|-1.56|3.69||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline insulin as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||3.69|-1.56|0.425
72360217|NCT00286442|144232267|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.87||||0.018|TWO_SIDED|95.0|0.5|5.23||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline insulin as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||5.23|0.50|0.018
72360218|NCT00286442|144232267|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.22||||0.067|TWO_SIDED|95.0|-0.15|4.6||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline insulin as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||4.60|-0.15|0.067
72360219|NCT00286442|144232268|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.036||||0.011|TWO_SIDED|95.0|-0.064|-0.009||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline proinsulin/insulin ratio as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.009|-0.064|0.011
72360220|NCT00286442|144232268|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.047|||<|0.001|TWO_SIDED|95.0|-0.075|-0.019||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline proinsulin/insulin ratio as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.019|-0.075|<0.001
72360221|NCT00286442|144232269|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.045|||<|0.001|TWO_SIDED|95.0|-0.07|-0.021||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline proinsulin/insulin ratio as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.021|-0.070|<0.001
72360222|NCT00286442|144232269|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.037||||0.004|TWO_SIDED|95.0|-0.062|-0.012||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline proinsulin/insulin ratio as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.012|-0.062|0.004
72360223|NCT00286442|144232270|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.039||||0.007|TWO_SIDED|95.0|-0.068|-0.011||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline proinsulin/insulin ratio as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm|||-0.011|-0.068|0.007
72360224|NCT00286442|144232270|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.037||||0.011|TWO_SIDED|95.0|-0.066|-0.008||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline proinsulin/insulin ratio as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm|||-0.008|-0.066|0.011
72360225|NCT00286442|144232271|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.052|||<|0.001|TWO_SIDED|95.0|-0.08|-0.024||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline proinsulin/insulin ratio as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.024|-0.080|<0.001
72360226|NCT00286442|144232271|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.044||||0.003|TWO_SIDED|95.0|-0.072|-0.015||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline proinsulin/insulin ratio as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.015|-0.072|0.003
72360227|NCT00286442|144232272|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.046||||0.078|TWO_SIDED|95.0|-0.097|0.005||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline proinsulin/insulin ratio as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.005|-0.097|0.078
72360228|NCT00286442|144232272|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.005||||0.86|TWO_SIDED|95.0|-0.056|0.047||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline proinsulin/insulin ratio as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.047|-0.056|0.860
72360229|NCT00286442|144232273|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.053||||0.048|TWO_SIDED|95.0|-0.106|-0.001||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline proinsulin/insulin ratio as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.001|-0.106|0.048
72360230|NCT00286442|144232273|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.004||||0.889|TWO_SIDED|95.0|-0.057|0.05||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline proinsulin/insulin ratio as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.050|-0.057|0.889
72360231|NCT00286442|144232274|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.336||||0.031|TWO_SIDED|95.0|0.03|0.642||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline C-peptide as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.642|0.030|0.031
72360232|NCT00286442|144232274|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.304||||0.051|TWO_SIDED|95.0|-0.002|0.611||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline C-peptide as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.611|-0.002|0.051
72360233|NCT00286442|144232275|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.088||||0.563|TWO_SIDED|95.0|-0.209|0.384||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline C-peptide as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.384|-0.209|0.563
72360234|NCT00286442|144232275|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.111||||0.467|TWO_SIDED|95.0|-0.188|0.41||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline C-peptide as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.410|-0.188|0.467
72360235|NCT00286442|144232276|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.187||||0.243|TWO_SIDED|95.0|-0.127|0.501||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline C-peptide as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.501|-0.127|0.243
72360236|NCT00286442|144232276|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.279||||0.083|TWO_SIDED|95.0|-0.037|0.595||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline C-peptide as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.595|-0.037|0.083
72360237|NCT00286442|144232277|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.155||||0.321|TWO_SIDED|95.0|-0.152|0.463||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline C-peptide as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.463|-0.152|0.321
72360238|NCT00286442|144232277|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.268||||0.089|TWO_SIDED|95.0|-0.041|0.577||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline C-peptide as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.577|-0.041|0.089
72360239|NCT00286442|144232278|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.144||||0.305|TWO_SIDED|95.0|-0.132|0.42||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline C-peptide as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.420|-0.132|0.305
72360240|NCT00286442|144232278|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.191||||0.177|TWO_SIDED|95.0|-0.086|0.468||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline C-peptide as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.468|-0.086|0.177
72360241|NCT00286442|144232279|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.394||||0.007|TWO_SIDED|95.0|0.107|0.68||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline C-peptide as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.680|0.107|0.007
72360242|NCT00286442|144232279|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.263||||0.074|TWO_SIDED|95.0|-0.025|0.55||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline C-peptide as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.550|-0.025|0.074
72360243|NCT00286442|144232280|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.15|||<|0.001|TWO_SIDED|95.0|2.117|17.864||no multiplicity adjustments.|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline metformin dose and baseline HbA1c.|Odd's Ratio (OR) is alogliptin arm versus placebo. OR \>1.0 indicates higher incidence of response compared to placebo.|||17.864|2.117|<0.001
72360244|NCT00286442|144232280|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.322||||0.002|TWO_SIDED|95.0|1.82|15.564||No multiplicity adjustments.|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline metformin dose and baseline HbA1c.|Odd's Ratio (OR) is alogliptin arm versus placebo. OR \>1.0 indicates higher incidence of response compared to placebo.|||15.564|1.820|0.002
72360245|NCT00286442|144232281|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.092|||<|0.001|TWO_SIDED|95.0|3.271|11.345||No multiplicity adjustments.|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline metformin dose and baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \>1.0 indicates higher incidence of response compared to placebo.|||11.345|3.271|<0.001
72360246|NCT00286442|144232281|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.451|||<|0.001|TWO_SIDED|95.0|2.388|8.296||No multiplicity adjustments.|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline metformin dose and baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \>1.0 indicates higher incidence of response compared to placebo.|||8.296|2.388|<0.001
72360247|NCT00286442|144232282|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.238|||<|0.001|TWO_SIDED|95.0|2.327|7.717||No multiplicity adjustments.|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline metformin dose and baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \>1.0 indicates higher incidence of response compared to placebo.|||7.717|2.327|<0.001
72360248|NCT00286442|144232282|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.293|||<|0.001|TWO_SIDED|95.0|1.814|5.979|||Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline metformin dose and baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \>1.0 indicates higher incidence of response compared to placebo.|||5.979|1.814|<0.001
72360249|NCT00286442|144232283|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.103|||<|0.001|TWO_SIDED|95.0|2.428|6.934||No multiplicity adjustments.|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline metformin dose and baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \>1.0 indicates higher incidence of response compared to placebo.|||6.934|2.428|<0.001
72360250|NCT00286442|144232283|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.314|||<|0.001|TWO_SIDED|95.0|2.545|7.312||No multiplicity adjustments.|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline metformin dose and baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \>1.0 indicates higher incidence of response compared to placebo.|||7.312|2.545|<0.001
72360251|NCT00286442|144232284|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.601|||<|0.001|TWO_SIDED|95.0|2.554|12.282||No multiplicity adjustments.|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline metformin dose and baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \>1.0 indicates higher incidence of response compared to placebo.|||12.282|2.554|<0.001
72360252|NCT00286442|144232284|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.793|||<|0.001|TWO_SIDED|95.0|2.645|12.684||No multiplicity adjustments.|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline metformin dose and baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \>1.0 indicates higher incidence of response compared to placebo.|||12.684|2.645|<0.001
72360253|NCT00286442|144232285|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.449||||0.085|TWO_SIDED|95.0|0.883|6.797||No multiplicity adjustments.|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline metformin dose and baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \>1.0 indicates higher incidence of response compared to placebo.|||6.797|0.883|0.085
72360254|NCT00286442|144232285|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.958||||0.034|TWO_SIDED|95.0|1.087|8.046||No multiplicity adjustments.|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline metformin dose and baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \>1.0 indicates higher incidence of response compared to placebo.|||8.046|1.087|0.034
72360255|NCT00286442|144232286|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.404||||0.639|TWO_SIDED|95.0|0.34|5.803||No multiplicity adjustments.|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline metformin dose and baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \>1.0 indicates higher incidence of response compared to placebo.|||5.803|0.340|0.639
72360256|NCT00286442|144232286|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.959||||0.956|TWO_SIDED|95.0|0.218|4.223||No multiplicity adjustments.|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline metformin dose and baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \>1.0 indicates higher incidence of response compared to placebo.|||4.223|0.218|0.956
72360257|NCT00286442|144232287|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.18||||0.439|TWO_SIDED|95.0|-0.63|0.27||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline weight as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.27|-0.63|0.439
72360258|NCT00286442|144232287|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.41||||0.075|TWO_SIDED|95.0|-0.86|0.04||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline weight as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.04|-0.86|0.075
72360259|NCT00286442|144232288|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.29||||0.305|TWO_SIDED|95.0|-0.26|0.83||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline weight as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.83|-0.26|0.305
72360260|NCT00286442|144232288|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.08||||0.788|TWO_SIDED|95.0|-0.63|0.47||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline weight as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.47|-0.63|0.788
72360261|NCT00286442|144232289|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.03||||0.93|TWO_SIDED|95.0|-0.58|0.63||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline weight as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.63|-0.58|0.930
72360262|NCT00286442|144232289|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.18||||0.559|TWO_SIDED|95.0|-0.79|0.43||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline weight as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.43|-0.79|0.559
72360263|NCT00286442|144232290|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.996|TWO_SIDED|95.0|-0.66|0.66||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline weight as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.66|-0.66|0.996
72360264|NCT00286442|144232290|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.28||||0.407|TWO_SIDED|95.0|-0.94|0.38||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline weight as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.38|-0.94|0.407
72360265|NCT02542865|144232337|SUPERIORITY||Mean Difference (Net)|-6.0|STANDARD_ERROR_OF_MEAN|1.56||0.0628|TWO_SIDED|95.0|-12.7|0.8|||ANCOVA|Analysis of variance(ANCOVA):cluster/school=random effect,product group and gender=fixed effects,baseline Individual Dietary Diversity Score=covariate|Difference is difference in back-transformed adjusted means for Test Group (fortified malt based food plus dietary counselling) minus Control Group (dietary counselling only).|||0.8|-12.7|0.0628
72360266|NCT02542865|144232337|SUPERIORITY||Mean Difference (Net)|-4.9||||0.039|||||||ANCOVA|ANCOVA:cluster/school=random effect,product group and gender=fixed effects,baseline Individual Dietary Diversity Score=covariate|Difference is difference in back-transformed adjusted means for Test Group minus Control Group. The corresponding CI is not presented as there is no direct back-transformation.|Since the distribution of the data was found to be more skewed with more zero counts than was anticipated at the time the trial was designed, an additional analysis of log (+1)-transformed data was performed.||||0.0390
72360267|NCT04913610|144232360|OTHER||||||=|0.036|||||||Mann-Whitney U test|The p-value is for the pairwise comparison of Arm A to Arm E using the Mann-Whitney U test for the percentage per participant.||Part 1: ABBV-4083 400 mg + albendazole pbo for 7 days, then ABBV-4083 pbo for 7 days (Arm A) versus Part 1: ABBV-4083 pbo + albendazole 400 mg for 7 days, then ABBV-4083 pbo for 7 days (Arm E)||||=0.036
72360268|NCT04913610|144232360|OTHER||||||=|0.53||||||The p-value is for the pairwise comparison of Arm B to Arm E using the Mann-Whitney U test for the percentage per participant.|Mann-Whitney U test|||Part 1: ABBV-4083 400 mg + albendazole pbo for 7 days, then ABBV-4083 400 mg for 7 days (Arm B) versus Part 1: ABBV-4083 pbo + albendazole 400 mg for 7 days, then ABBV-4083 pbo for 7 days (Arm E)||||=0.530
72360269|NCT04913610|144232360|OTHER||||||=|0.852||||||The p-value is for the pairwise comparison of Arm C to Arm E using the Mann-Whitney U test for the percentage per participant.|Mann-Whitney U test|||Part 1: ABBV-4083 400 mg + albendazole 400 mg for 7 days, then ABBV-4083 pbo for 7 days (Arm C) versus Part 1: ABBV-4083 pbo + albendazole 400 mg for 7 days, then ABBV-4083 pbo for 7 days (Arm E)||||=0.852
72360270|NCT04913610|144232360|OTHER||||||=|0.366||||||The p-value is for the pairwise comparison of Arm D to Arm E using the Mann-Whitney U test for the percentage per participant.|Mann-Whitney U test|||Part 1: ABBV-4083/albendazole 400 mg 3 d; ABBV-4083 400 mg/albendazole pbo 4 d; ABBV-4083 pbo 7 d (Arm D) versus Part 1: ABBV-4083 pbo + albendazole 400 mg for 7 days, then ABBV-4083 pbo for 7 days (Arm E)||||=0.366
72360271|NCT04913610|144232361|OTHER||||||=|0.869||||||The p-value is for the pairwise comparison of Arm A to Arm E using the Mann-Whitney U test for the percentage per participant.|Mann-Whitney U test|||Part 1: ABBV-4083 400 mg + albendazole pbo for 7 days, then ABBV-4083 pbo for 7 days (Arm A) versus Part 1: ABBV-4083 pbo + albendazole 400 mg for 7 days, then ABBV-4083 pbo for 7 days (Arm E)||||=0.869
72360272|NCT04913610|144232361|OTHER||||||=|0.973||||||The p-value is for the pairwise comparison of Arm B to Arm E using the Mann-Whitney U test for the percentage per participant.|Mann-Whitney U test|||Part 1: ABBV-4083 400 mg + albendazole pbo for 7 days, then ABBV-4083 400 mg for 7 days (Arm B) versus Part 1: ABBV-4083 pbo + albendazole 400 mg for 7 days, then ABBV-4083 pbo for 7 days (Arm E)||||=0.973
72360273|NCT04913610|144232361|OTHER||||||=|0.744||||||The p-value is for the pairwise comparison of Arm C to Arm E using the Mann-Whitney U test for the percentage per participant.|Mann-Whitney U test|||Part 1: ABBV-4083 400 mg + albendazole 400 mg for 7 days, then ABBV-4083 pbo for 7 days (Arm C) versus Part 1: ABBV-4083 pbo + albendazole 400 mg for 7 days, then ABBV-4083 pbo for 7 days (Arm E)||||=0.744
72360274|NCT04913610|144232361|OTHER||||||=|0.794||||||The p-value is for the pairwise comparison of Arm D to Arm E using the Mann-Whitney U test for the percentage per participant.|Mann-Whitney U test|||Part 1: ABBV-4083/albendazole 400 mg 3 d; ABBV-4083 400 mg/albendazole pbo 4 d; ABBV-4083 pbo 7 d (Arm D) versus Part 1: ABBV-4083 pbo + albendazole 400 mg for 7 days, then ABBV-4083 pbo for 7 days (Arm E)||||=0.794
72360275|NCT04913610|144232362|OTHER||||||=|0.559||||||The p-value is for the pairwise comparison of Arm A to Arm E using the using the Chi-square test for the binary response per participant.|Chi-square test|||Part 1: ABBV-4083 400 mg + albendazole pbo for 7 days, then ABBV-4083 pbo for 7 days (Arm A) versus Part 1: ABBV-4083 pbo + albendazole 400 mg for 7 days, then ABBV-4083 pbo for 7 days (Arm E)||||=0.559
72360276|NCT04913610|144232362|OTHER||||||=|0.786||||||The p-value is for the pairwise comparison of Arm B to Arm E using the using the Chi-square test for the binary response per participant.|Chi-square test|||Part 1: ABBV-4083 400 mg + albendazole pbo for 7 days, then ABBV-4083 400 mg for 7 days (Arm B) versus Part 1: ABBV-4083 pbo + albendazole 400 mg for 7 days, then ABBV-4083 pbo for 7 days (Arm E)||||=0.786
72360277|NCT04913610|144232362|OTHER||||||=|0.423||||||The p-value is for the pairwise comparison of Arm C to Arm E using the using the Chi-square test for the binary response per participant.|Chi-square test|||Part 1: ABBV-4083 400 mg + albendazole 400 mg for 7 days, then ABBV-4083 pbo for 7 days (Arm C) versus Part 1: ABBV-4083 pbo + albendazole 400 mg for 7 days, then ABBV-4083 pbo for 7 days (Arm E)||||=0.423
72360278|NCT04913610|144232362|OTHER||||||=|0.92||||||The p-value is for the pairwise comparison of Arm D to Arm E using the using the Chi-square test for the binary response per participant.|Chi-square test|||Part 1: ABBV-4083/albendazole 400 mg 3 d; ABBV-4083 400 mg/albendazole pbo 4 d; ABBV-4083 pbo 7 d (Arm D) versus Part 1: ABBV-4083 pbo + albendazole 400 mg for 7 days, then ABBV-4083 pbo for 7 days (Arm E)||||=0.920
72360279|NCT04913610|144232363|OTHER||||||=|0.981||||||The p-value is for the pairwise comparison of Arm A to Arm E using the using the Chi-square test for the binary response per participant.|Chi-square test|||Part 1: ABBV-4083 400 mg + albendazole pbo for 7 days, then ABBV-4083 pbo for 7 days (Arm A) versus Part 1: ABBV-4083 pbo + albendazole 400 mg for 7 days, then ABBV-4083 pbo for 7 days (Arm E)||||=0.981
72360280|NCT04913610|144232363|OTHER||||||=|0.981||||||The p-value is for the pairwise comparison of Arm B to Arm E using the using the Chi-square test for the binary response per participant.|Chi-square test|||Part 1: ABBV-4083 400 mg + albendazole pbo for 7 days, then ABBV-4083 400 mg for 7 days (Arm B) versus Part 1: ABBV-4083 pbo + albendazole 400 mg for 7 days, then ABBV-4083 pbo for 7 days (Arm E)||||=0.981
72360281|NCT04913610|144232363|OTHER||||||=|0.96||||||The p-value is for the pairwise comparison of Arm C to Arm E using the using the Chi-square test for the binary response per participant.|Chi-square test|||Part 1: ABBV-4083 400 mg + albendazole 400 mg for 7 days, then ABBV-4083 pbo for 7 days (Arm C) versus Part 1: ABBV-4083 pbo + albendazole 400 mg for 7 days, then ABBV-4083 pbo for 7 days (Arm E)||||=0.960
72360282|NCT04913610|144232363|OTHER||||||=|0.96||||||The p-value is for the pairwise comparison of Arm D to Arm E using the using the Chi-square test for the binary response per participant.|Chi-square test|||Part 1: ABBV-4083/albendazole 400 mg 3 d; ABBV-4083 400 mg/albendazole pbo 4 d; ABBV-4083 pbo 7 d (Arm D) versus Part 1: ABBV-4083 pbo + albendazole 400 mg for 7 days, then ABBV-4083 pbo for 7 days (Arm E)||||=0.960
72360283|NCT04913610|144232364|OTHER||||||=|0.157||||||The p-value is for the pairwise comparison of Arm A to Arm E using the using the Chi-square test for the binary response per participant.|Chi-square test|||Part 1: ABBV-4083 400 mg + albendazole pbo for 7 days, then ABBV-4083 pbo for 7 days (Arm A) versus Part 1: ABBV-4083 pbo + albendazole 400 mg for 7 days, then ABBV-4083 pbo for 7 days (Arm E)||||=0.157
72360284|NCT04913610|144232364|OTHER||||||=|0.15||||||The p-value is for the pairwise comparison of Arm B to Arm E using the using the Chi-square test for the binary response per participant.|Chi-square test|||Part 1: ABBV-4083 400 mg + albendazole pbo for 7 days, then ABBV-4083 400 mg for 7 days (Arm B) versus Part 1: ABBV-4083 pbo + albendazole 400 mg for 7 days, then ABBV-4083 pbo for 7 days (Arm E)||||=0.150
72360285|NCT04913610|144232364|OTHER||||||=|0.15||||||The p-value is for the pairwise comparison of Arm C to Arm E using the using the Chi-square test for the binary response per participant.|Chi-square test|||Part 1: ABBV-4083 400 mg + albendazole 400 mg for 7 days, then ABBV-4083 pbo for 7 days (Arm C) versus Part 1: ABBV-4083 pbo + albendazole 400 mg for 7 days, then ABBV-4083 pbo for 7 days (Arm E)||||=0.150
72360286|NCT04913610|144232364|OTHER||||||=|0.173||||||The p-value is for the pairwise comparison of Arm D to Arm E using the using the Chi-square test for the binary response per participant.|Chi-square test|||Part 1: ABBV-4083/albendazole 400 mg 3 d; ABBV-4083 400 mg/albendazole pbo 4 d; ABBV-4083 pbo 7 d (Arm D) versus Part 1: ABBV-4083 pbo + albendazole 400 mg for 7 days, then ABBV-4083 pbo for 7 days (Arm E)||||=0.173
72360287|NCT04913610|144232365|OTHER||||||=|0.619||||||The p-value is for the pairwise comparison of Arm A to Arm E using the Mann-Whitney U test for the change from baseline in skin microfilarial density per participant.|Mann-Whitney U test|||Part 1: ABBV-4083 400 mg + albendazole pbo for 7 days, then ABBV-4083 pbo for 7 days (Arm A) versus Part 1: ABBV-4083 pbo + albendazole 400 mg for 7 days, then ABBV-4083 pbo for 7 days (Arm E)||||=0.619
72360288|NCT04913610|144232365|OTHER||||||=|0.194||||||The p-value is for the pairwise comparison of Arm B to Arm E using the Mann-Whitney U test for the change from baseline in skin microfilarial density per participant.|Mann-Whitney U test|||Part 1: ABBV-4083 400 mg + albendazole pbo for 7 days, then ABBV-4083 400 mg for 7 days (Arm B) versus Part 1: ABBV-4083 pbo + albendazole 400 mg for 7 days, then ABBV-4083 pbo for 7 days (Arm E)||||=0.194
72360289|NCT04913610|144232365|OTHER||||||=|0.518||||||The p-value is for the pairwise comparison of Arm C to Arm E using the Mann-Whitney U test for the change from baseline in skin microfilarial density per participant.|Mann-Whitney U test|||Part 1: ABBV-4083 400 mg + albendazole 400 mg for 7 days, then ABBV-4083 pbo for 7 days (Arm C) versus Part 1: ABBV-4083 pbo + albendazole 400 mg for 7 days, then ABBV-4083 pbo for 7 days (Arm E)||||=0.518
72360290|NCT04913610|144232365|OTHER||||||=|0.652||||||The p-value is for the pairwise comparison of Arm D to Arm E using the Mann-Whitney U test for the change from baseline in skin microfilarial density per participant.|Mann-Whitney U test|||Part 1: ABBV-4083/albendazole 400 mg 3 d; ABBV-4083 400 mg/albendazole pbo 4 d; ABBV-4083 pbo 7 d (Arm D) versus Part 1: ABBV-4083 pbo + albendazole 400 mg for 7 days, then ABBV-4083 pbo for 7 days (Arm E)||||=0.652
72360291|NCT04913610|144232366|OTHER||||||=|0.386||||||The p-value is for the pairwise comparison of Arm A to Arm E using the Mann-Whitney U test for the change from baseline in skin microfilarial density per participant.|Mann-Whitney U test|||Part 1: ABBV-4083 400 mg + albendazole pbo for 7 days, then ABBV-4083 pbo for 7 days (Arm A) versus Part 1: ABBV-4083 pbo + albendazole 400 mg for 7 days, then ABBV-4083 pbo for 7 days (Arm E)||||=0.386
72360292|NCT04913610|144232366|OTHER||||||=|0.279||||||The p-value is for the pairwise comparison of Arm B to Arm E using the Mann-Whitney U test for the change from baseline in skin microfilarial density per participant.|Mann-Whitney U test|||Part 1: ABBV-4083 400 mg + albendazole pbo for 7 days, then ABBV-4083 400 mg for 7 days (Arm B) versus Part 1: ABBV-4083 pbo + albendazole 400 mg for 7 days, then ABBV-4083 pbo for 7 days (Arm E)||||=0.279
72360293|NCT04913610|144232366|OTHER||||||=|0.385||||||The p-value is for the pairwise comparison of Arm C to Arm E using the Mann-Whitney U test for the change from baseline in skin microfilarial density per participant.|Mann-Whitney U test|||Part 1: ABBV-4083 400 mg + albendazole 400 mg for 7 days, then ABBV-4083 pbo for 7 days (Arm C) versus Part 1: ABBV-4083 pbo + albendazole 400 mg for 7 days, then ABBV-4083 pbo for 7 days (Arm E)||||=0.385
72360294|NCT04913610|144232366|OTHER||||||=|0.755||||||The p-value is for the pairwise comparison of Arm D to Arm E using the Mann-Whitney U test for the change from baseline in skin microfilarial density per participant.|Mann-Whitney U test|||Part 1: ABBV-4083/albendazole 400 mg 3 d; ABBV-4083 400 mg/albendazole pbo 4 d; ABBV-4083 pbo 7 d (Arm D) versus Part 1: ABBV-4083 pbo + albendazole 400 mg for 7 days, then ABBV-4083 pbo for 7 days (Arm E)||||=0.755
72360295|NCT01210716|144232368|NON_INFERIORITY_OR_EQUIVALENCE|If the lower 97.5% confidence limit on the mean of the paired differences is greater than -15% of the Control group mean (i.e., p-value \<=0.05), then the Test group will be considered non-inferior in the primary efficacy parameter to Control at the margin of 15%.|Mean Difference (Final Values)|6.69|STANDARD_DEVIATION|6.97|<|0.001|ONE_SIDED|95.0|4.0||||paired t-test|||A one-sample t-test on the mean of paired differences was used to evaluate the primary objective. Sample size was determined using historical data and the 95% chi-square upper confidence limit on the observed standard deviation of the paired differences. A minimum sample of 27 pairs was required to demonstrate the AMICUS procedure to be non-inferior to Spectra with a mean efficiency of plasma removal with a non-inferiority margin of 15% with at least 97.5% (one-sided) confidence and 90% power.|||4.0|<0.001
72360296|NCT02913482|144232441|SUPERIORITY|Result compared to a performance criterion of 5% derived from natural history data.|||||<|0.0001|||||||One-sided Exact Binomial Test|||||||<0.0001
72360297|NCT02913482|144232442|SUPERIORITY|Result compared to a performance criterion of 17% derived from natural history data.|||||<|0.0001|||||||One-sided Exact Binomial Test|||||||<0.0001
72360298|NCT02913482|144232443|SUPERIORITY|Result compared to a performance criterion of 17% derived from natural history data. Statistical analysis was only performed for Month 12 data.|||||<|0.0001|||||||One-sided Exact Binomial Test|||||||<0.0001
72360299|NCT02913482|144232449|SUPERIORITY|Result compared to a performance criterion of 12% derived from natural history data. Statistical analysis was only performed for Month 12 data.|||||<|0.0001|||||||One-sided Exact Binomial Test|||||||<0.0001
72360300|NCT02913482|144232451|SUPERIORITY|Result compared to a performance criterion of 5% derived from natural history data.|||||<|0.0001|||||||One-sided Exact Binomial Test|||||||<0.0001
72360301|NCT02913482|144232452|SUPERIORITY|Result compared to a performance criterion of 5% derived from natural history data.|||||<|0.0001|||||||One-sided Exact Binomial Test|||||||<0.0001
72360302|NCT02913482|144232453|SUPERIORITY|Result compared to a performance criterion of 5% derived from natural history data.||||||1|||||||One-sided Exact Binomial Test|||||||1.0000
72360303|NCT02913482|144232454|SUPERIORITY|Result compared to a performance criterion of 5% derived from natural history data.||||||1|||||||One-sided Exact Binomial Test|||||||1.0000
72360304|NCT02913482|144232458|SUPERIORITY|Result compared to a performance criterion of 42% derived from natural history data. Statistical analysis was only performed for Month 12 data.|||||<|0.0001|||||||One-sided Z-test|||||||<0.0001
72360305|NCT02913482|144232459|SUPERIORITY|Result compared to a performance criterion of 60% derived from natural history data. Statistical analysis was only performed for Month 12 data.||||||0.0005|||||||One-sided Z-test|||||||0.0005
72360306|NCT02913482|144232460|SUPERIORITY|Result compared to a performance criterion of 89% derived from natural history data. Statistical analysis was only performed for Month 12 data.||||||0.2595|||||||One-sided Z-test|||||||0.2595
72360307|NCT01983228|144232473|SUPERIORITY||Odds Ratio (OR)|1.61||||0.09|TWO_SIDED|95.0|0.94|2.77||Multiple logistic regression adjusted for use of walking aids and opioids (both significantly difference between arms at baseline).|Regression, Logistic|||measured change as a responder yes/no (30% or greater improvement from baseline).||2.77|0.94|0.09
72360308|NCT01983228|144232474|SUPERIORITY||Median Difference (Final Values)|-0.2||||0.34|TWO_SIDED|95.0|-0.62|0.21||Multiple linear regression adjusted for use of walking aids and opioids (both significantly difference between arms at baseline).|Regression, Linear|||||0.21|-0.62|0.34
72360309|NCT01983228|144232475|SUPERIORITY||Mean Difference (Final Values)|-0.52||||0.38|TWO_SIDED|95.0|-1.69|0.65||Multiple linear regression adjusted for use of walking aids and opioids (both significantly difference between arms at baseline).|Regression, Linear|||||0.65|-1.69|0.38
72360310|NCT01983228|144232476|SUPERIORITY||Mean Difference (Final Values)|-0.59||||0.28|TWO_SIDED|95.0|-1.68|0.49||Multiple linear regression adjusted for use of walking aids and opioids (both significantly difference between arms at baseline).|Regression, Linear|||||0.49|-1.68|0.28
72360311|NCT01983228|144232477|SUPERIORITY||Mean Difference (Final Values)|0.38||||0.05|TWO_SIDED|95.0|0.0|0.77||Multiple linear regression adjusted for use of walking aids and opioids (both significantly difference between arms at baseline).|Regression, Linear|||||0.77|-0.00|0.05
72360312|NCT01983228|144232478|SUPERIORITY|Multiple linear regression adjusted for use of walking aids and opioids (both significantly difference between arms at baseline).|Mean Difference (Final Values)|193.9||||0.56|TWO_SIDED|95.0|-454.93|842.73||Multiple linear regression adjusted for use of walking aids and opioids (both significantly difference between arms at baseline).|Regression, Linear|||||842.73|-454.93|0.56
72360313|NCT01983228|144232479|SUPERIORITY||Odds Ratio (OR)|1.49||||0.16|TWO_SIDED|95.0|0.85|2.62||Multiple logistic regression adjusted for use of walking aids and opioids (both significantly difference between arms at baseline).|Regression, Logistic|||measured change as a responder yes/no (30% or greater improvement from baseline).||2.62|0.85|0.16
72360314|NCT01983228|144232480|SUPERIORITY||Mean Difference (Final Values)|-0.61||||0.002|TWO_SIDED|95.0|-0.99|-0.23||Multiple linear regression adjusted for use of walking aids and opioids (both significantly difference between arms at baseline).|Regression, Linear|||||-0.23|-0.99|0.002
72360315|NCT01983228|144232481|SUPERIORITY||Mean Difference (Final Values)|0.36||||0.54|TWO_SIDED|95.0|-0.79|1.51||Multiple linear regression adjusted for use of walking aids and opioids (both significantly difference between arms at baseline).|Regression, Linear|||||1.51|-0.79|0.54
72360316|NCT01983228|144232482|SUPERIORITY||Mean Difference (Final Values)|0.48||||0.41|TWO_SIDED|95.0|-0.66|1.62||Multiple linear regression adjusted for use of walking aids and opioids (both significantly difference between arms at baseline).|Regression, Linear|||||1.62|-0.66|0.41
72360317|NCT01983228|144232483|SUPERIORITY||Mean Difference (Final Values)|-0.72|||<|0.0001|TWO_SIDED|95.0|-1.07|-0.38||Multiple linear regression adjusted for use of walking aids and opioids (both significantly difference between arms at baseline).|Regression, Linear|||||-0.38|-1.07|<0.0001
72360318|NCT01983228|144232484|SUPERIORITY||Mean Difference (Final Values)|540.78||||0.06|TWO_SIDED|95.0|-28.77|1110.33||Multiple linear regression adjusted for use of walking aids and opioids (both significantly difference between arms at baseline).|Regression, Linear|||||1110.33|-28.77|0.06
72360319|NCT01983228|144232485|SUPERIORITY||Mean Difference (Final Values)|2.93||||0.05|TWO_SIDED|95.0|-0.01|5.86||Multiple linear regression adjusted for use of walking aids and opioids (both significantly difference between arms at baseline).|Regression, Linear|||||5.86|-0.01|0.05
72360320|NCT01983228|144232486|SUPERIORITY||Mean Difference (Final Values)|0.76||||0.01|TWO_SIDED|95.0|0.15|1.36||Multiple linear regression adjusted for use of walking aids and opioids (both significantly difference between arms at baseline).|Regression, Linear|||||1.36|0.15|0.01
72360321|NCT01983228|144232487|SUPERIORITY||Mean Difference (Final Values)|-1.07||||0.15|TWO_SIDED|95.0|-2.53|0.39||Multiple linear regression adjusted for use of walking aids and opioids (both significantly difference between arms at baseline).|Regression, Linear|||||0.39|-2.53|0.15
72360322|NCT01983228|144232488|SUPERIORITY||Mean Difference (Final Values)|0.33||||0.56|TWO_SIDED|95.0|-0.8|1.47||Multiple linear regression adjusted for use of walking aids and opioids (both significantly difference between arms at baseline).|Regression, Linear|||||1.47|-0.80|0.56
72360323|NCT01983228|144232489|SUPERIORITY||Mean Difference (Final Values)|0.14||||0.38|TWO_SIDED|95.0|-0.17|0.46||Multiple linear regression adjusted for use of walking aids and opioids (both significantly difference between arms at baseline).|Regression, Linear|||||0.46|-0.17|0.38
72360324|NCT01983228|144232490|SUPERIORITY||Odds Ratio (OR)|1.2||||0.56|TWO_SIDED|95.0|0.66|2.19||Logistic regression modeling the odds of yes to using opioids for pain treatment adjusting for use of walking aids and opioids (both significantly difference between arms at baseline).|Regression, Logistic|||||2.19|0.66|0.56
72360325|NCT01983228|144232491|SUPERIORITY||Mean Difference (Final Values)|0.33||||0.21|TWO_SIDED|95.0|-0.18|0.84||Multiple linear regression adjusted for use of walking aids and opioids (both significantly difference between arms at baseline).|Regression, Linear|||||0.84|-0.18|0.21
72360326|NCT02005016|144232497|OTHER|This was a single-group study. A t-test was administered comparing pre- and post-treatment PNT scores (range: 1-175; higher scores are better).|||||<|0.005|||||||t-test, 1 sided|||||||<0.005
72360327|NCT02005016|144232498|OTHER|This was a single-group study. A t-test was administered comparing pre- and post-treatment CAT modality mean T-scores (range: 30-70, mean: 50; higher scores are better).|||||<|0.001|||||||t-test, 1 sided|||||||<0.001
72360328|NCT00083889|144232499|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.5268|||<|0.0001|TWO_SIDED|95.0|0.4316|0.643||p-value from 2-sided, unstratified test.|Log Rank||Assuming proportional hazards, a hazard ratio les than 1 indicates a reduction in hazard rate in favor of SU011248; a hazard ratio greater than 1 indicates a reduction in favor of IFN-a.|Unstratified analysis: Hazard Ratio (SU011248 vs IFN-α). Progression-free survival (PFS) was assessed in each treatment arm using the Kaplan-Meier method.||0.6430|0.4316|<0.0001
72360329|NCT00083889|144232499|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.5136|||<|1e-05|TWO_SIDED|95.0|0.4196|0.6288||p-value is from 2-sided, stratified test. Stratification factors were: Lactic Dehydrogenase (LDH) \> or \<= 1.5 x upper limit of normal, Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1, and absence or presence of prior nephrectomy.|Log Rank||Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of SU011248: a hazard ratio greater than 1 indicates a reduction in favor of IFN-a.|Stratified analysis: Hazard Ratio (SU011248 vs IFN-a).||0.6288|0.4196|<.00001
72360330|NCT00083889|144232500|SUPERIORITY_OR_OTHER||treatment difference|30.93|||<|0.001|TWO_SIDED|95.0|25.31|36.56|||Chi-squared||95% confidence interval was calculated based on a normal distribution.|||36.56|25.31|<0.001
72360331|NCT00083889|144232501|SUPERIORITY_OR_OTHER||treatment difference|33.66|||<|0.001|TWO_SIDED|95.0|27.62|39.69|||Chi-squared||95% confidence interval was calculated based on a normal distribution.|||39.69|27.62|<0.001
72360332|NCT00083889|144232502|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.8209||||0.051|TWO_SIDED|95.0|0.673|1.0013||p-value is from 2-sided, unstratified tests.|Log Rank||Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of SU011248; a hazard ratio greater than 1 indicates a reduction in hazard rate in favor of IFN-a|Unstratified analysis: Hazard Ratio (SU011248 vs IFN-α).||1.0013|0.6730|0.0510
72360333|NCT00083889|144232502|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.8209||||0.0128|TWO_SIDED|95.0|0.673|1.0013||p-value is from 2-sided, unstratified tests.|Wilcoxon (Mann-Whitney)||Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of SU011248; a hazard ratio greater than 1 indicates a reduction in hazard rate in favor of IFN-a.|Unstratified analysis: Hazard Ratio (SU011248 vs IFN-α).||1.0013|0.6730|0.0128
72360334|NCT00083889|144232502|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.8179||||0.049|TWO_SIDED|95.0|0.6692|0.9995||p-value is from 2-sided, stratified tests. Stratification factors were: Lactic Dehydrogenase (LDH) \> or \<= 1.5 x upper limit of normal, Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1, and absence or presence of prior nephrectomy.|Log Rank||Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of SU011248; a hazard ratio greater than 1 indicates a reduction in hazard rate in favor of IFN-a.|Stratified analysis: Hazard Ratio (SU011248 vs IFN-α).||0.9995|0.6692|0.0490
72360335|NCT00083889|144232503|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.5332|||<|0.0001|TWO_SIDED|95.0|0.4345|0.6544||p-value is from 2-sided, unstratified test.|Log Rank||Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of SU011248; a hazard ratio greater than 1 indicates a reduction in hazard rate in favor of IFN-a|Unstratified Analysis: Hazard Ratio (SU011248 vs IFN-a)||0.6544|0.4345|<0.0001
72360336|NCT00083889|144232503|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.516|||<|1e-05|TWO_SIDED|95.0|0.4191|0.6352||p-value is from 2-sided, stratified test. Stratification factors are: Lactic Dehydrogenase (LDH) \> or \<= 1.5 x upper limit of normal, Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1, and absence or presence of prior nephrectomy.|Log Rank||Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of SU011248; a hazard ratio greater than 1 indicates a reduction in hazard rate in favor of IFN-a.|Stratified Analysis: Hazard Ratio (SU011248 vs IFN-a)||0.6352|0.4191|<.00001
72360337|NCT00083889|144232504|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.5454|||<|0.0001|TWO_SIDED|95.0|0.4558|0.6526||p-value is from 2-sided, unstratified test.|Log Rank||Assuming proportional hazards, a hazard ratio \< 1 indicates a reduction in hazard rate in favor of SU011248; a hazard ratio \> 1 indicates a reduction in hazard rate in favor of IFN-a.|Unstratified Analysis: Hazard Ratio (SU011248 vs IFN-α)||0.6526|0.4558|<0.0001
72360338|NCT00083889|144232504|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.5417|||<|1e-05|TWO_SIDED|95.0|0.4519|0.6492||p-value is from 2-sided, stratified test. Stratification factors were: Lactic Dehydrogenase (LDH) \> or \<= 1.5 x upper limit of normal, Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1, and absence or presence of prior nephrectomy.|Log Rank||Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of SU011248; a hazard ratio greater than 1 indicates a reduction in hazard rate in favor of IFN-a.|Stratified Analysis: Hazard Ratio (SU011248 vs IFN-α)||0.6492|0.4519|<.00001
72360339|NCT00083889|144232507|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.913|||<|0.0001|TWO_SIDED|95.0|1.376|2.45|||Mixed Models Analysis|||Cycle 1 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index-Disease Related Symptoms (FKSI-DRS) baseline score (intercept and time since randomization are included as random effects).||2.450|1.376|<.0001
72360340|NCT00083889|144232507|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.935|||<|0.0001|TWO_SIDED|95.0|1.421|2.449|||Mixed Models Analysis|||Cycle 1 Day 28: Difference in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).||2.449|1.421|<.0001
72360341|NCT00083889|144232507|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.948|||<|0.0001|TWO_SIDED|95.0|1.443|2.452|||Mixed Models Analysis|||Cycle 2 Day 1: Difference in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).||2.452|1.443|<.0001
72360342|NCT00083889|144232507|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.97|||<|0.0001|TWO_SIDED|95.0|1.476|2.464|||Mixed Models Analysis|||Cycle 2 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).||2.464|1.476|<.0001
72360343|NCT00083889|144232507|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.983|||<|0.0001|TWO_SIDED|95.0|1.491|2.475|||Mixed Models Analysis|||Cycle 3 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).||2.475|1.491|<.0001
72360344|NCT00083889|144232507|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.005|||<|0.0001|TWO_SIDED|95.0|1.51|2.501|||Mixed Models Analysis|||Cycle 3 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).||2.501|1.510|<.0001
72360345|NCT00083889|144232507|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.018|||<|0.0001|TWO_SIDED|95.0|1.517|2.519|||Mixed Models Analysis|||Cycle 4 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).||2.519|1.517|<.0001
72360346|NCT00083889|144232507|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.04|||<|0.0001|TWO_SIDED|95.0|1.522|2.559|||Mixed Models Analysis|||Cycle 4 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).||2.559|1.522|<.0001
72360347|NCT00083889|144232507|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.053|||<|0.0001|TWO_SIDED|95.0|1.522|2.584|||Mixed Models Analysis|||Cycle 5 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).||2.584|1.522|<.0001
72360348|NCT00083889|144232507|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.075|||<|0.0001|TWO_SIDED|95.0|1.515|2.635|||Mixed Models Analysis|||Cycle 5 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).||2.635|1.515|<.0001
72360349|NCT00083889|144232507|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.088|||<|0.0001|TWO_SIDED|95.0|1.509|2.667|||Mixed Models Analysis|||Cycle 6 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).||2.667|1.509|<.0001
72360350|NCT00083889|144232507|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.11|||<|0.0001|TWO_SIDED|95.0|1.494|2.727|||Mixed Models Analysis|||Cycle 6 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).||2.727|1.494|<.0001
72360351|NCT00083889|144232507|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.123|||<|0.0001|TWO_SIDED|95.0|1.483|2.763|||Mixed Models Analysis|||Cycle 7 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).||2.763|1.483|<.0001
72360352|NCT00083889|144232507|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.146|||<|0.0001|TWO_SIDED|95.0|1.461|2.83|||Mixed Models Analysis|||Cycle 7 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).||2.830|1.461|<.0001
72360353|NCT00083889|144232507|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|2.158|||<|0.0001|TWO_SIDED|95.0|1.447|2.869|||Mixed Models Analysis|||Cycle 8 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).||2.869|1.447|<.0001
72360354|NCT00083889|144232507|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.181|||<|0.0001|TWO_SIDED|95.0|1.42|2.941|||Mixed Models Analysis|||Cycle 8 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).||2.941|1.420|<.0001
72360355|NCT00083889|144232507|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.193|||<|0.0001|TWO_SIDED|95.0|1.404|2.983|||Mixed Models Analysis|||Cycle 9 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).||2.983|1.404|<.0001
72360356|NCT00083889|144232507|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.216|||<|0.0001|TWO_SIDED|95.0|1.373|3.059|||Mixed Models Analysis|||Cycle 9 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).||3.059|1.373|<.0001
72360357|NCT00083889|144232507|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.228|||<|0.0001|TWO_SIDED|95.0|1.355|3.102|||Mixed Models Analysis|||Cycle 10 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).||3.102|1.355|<.0001
72360358|NCT00083889|144232507|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.251|||<|0.0001|TWO_SIDED|95.0|1.321|3.18|||Mixed Models Analysis|||Cycle 10 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).||3.180|1.321|<.0001
72360359|NCT00083889|144232507|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.263|||<|0.0001|TWO_SIDED|95.0|1.302|3.225|||Mixed Models Analysis|||Cycle 11 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).||3.225|1.302|<.0001
72360360|NCT00083889|144232507|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.286|||<|0.0001|TWO_SIDED|95.0|1.266|3.305|||Mixed Models Analysis|||Cycle 11 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).||3.305|1.266|<.0001
72360361|NCT00083889|144232507|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.298|||<|0.0001|TWO_SIDED|95.0|1.246|3.351|||Mixed Models Analysis|||Cycle 12 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).||3.351|1.246|<.0001
72360362|NCT00083889|144232507|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.321|||<|0.0001|TWO_SIDED|95.0|1.209|3.433|||Mixed Models Analysis|||Cycle 12 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).||3.433|1.209|<.0001
72360363|NCT00083889|144232507|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.333|||<|0.0001|TWO_SIDED|95.0|1.188|3.479|||Mixed Models Analysis|||Cycle 13 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).||3.479|1.188|<.0001
72360364|NCT00083889|144232507|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.356||||0.0001|TWO_SIDED|95.0|1.15|3.562|||Mixed Models Analysis|||Cycle 13 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).||3.562|1.150|0.0001
72360365|NCT00083889|144232507|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.369||||0.0002|TWO_SIDED|95.0|1.128|3.609|||Mixed Models Analysis|||Cycle 14 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).||3.609|1.128|0.0002
72360366|NCT00083889|144232507|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.391||||0.0003|TWO_SIDED|95.0|1.089|3.693|||Mixed Models Analysis|||Cycle 14 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).||3.693|1.089|0.0003
72360367|NCT00083889|144232507|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.404||||0.0004|TWO_SIDED|95.0|1.067|3.74|||Mixed Models Analysis|||Cycle 15 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).||3.740|1.067|0.0004
72360368|NCT00083889|144232507|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.426||||0.0007|TWO_SIDED|95.0|1.027|3.825|||Mixed Models Analysis|||Cycle 15 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).||3.825|1.027|0.0007
72360369|NCT00083889|144232507|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.439||||0.0009||95.0|1.005|3.872|||Mixed Models Analysis|||Cycle 16 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).||3.872|1.005|0.0009
72360370|NCT00083889|144232507|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.461||||0.0013|TWO_SIDED|95.0|0.964|3.958|||Mixed Models Analysis|||Cycle 16 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).||3.958|0.964|0.0013
72360371|NCT00083889|144232507|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.474||||0.0016|TWO_SIDED|95.0|0.942|4.006|||Mixed Models Analysis|||Cycle 17 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).||4.006|0.942|0.0016
72360372|NCT00083889|144232507|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.496||||0.0022|TWO_SIDED|95.0|0.901|4.092|||Mixed Models Analysis|||Cycle 17 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).||4.092|0.901|0.0022
72360373|NCT00083889|144232507|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.509||||0.0026|TWO_SIDED|95.0|0.878|4.14|||Mixed Models Analysis|||Cycle 18 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).||4.140|0.878|0.0026
72360374|NCT00083889|144232507|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.531||||0.0034|TWO_SIDED|95.0|0.836|4.226|||Mixed Models Analysis|||Cycle 18 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).||4.226|0.836|0.0034
72360375|NCT00083889|144232507|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.544||||0.004|TWO_SIDED|95.0|0.813|4.274|||Mixed Models Analysis|||Cycle 19 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).||4.274|0.813|0.0040
72360376|NCT00083889|144232507|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.566||||0.0051|TWO_SIDED|95.0|0.772|4.361|||Mixed Models Analysis|||Cycle 19 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).||4.361|0.772|0.0051
72360377|NCT00083889|144232507|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.579||||0.0058|TWO_SIDED|95.0|0.748|4.41|||Mixed Models Analysis|||Cycle 20 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).||4.410|0.748|0.0058
72360378|NCT00083889|144232507|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.602||||0.0071|TWO_SIDED|95.0|0.706|4.497|||Mixed Models Analysis|||Cycle 20 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).||4.497|0.706|0.0071
72360379|NCT00083889|144232508|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.165|||<|0.0001|TWO_SIDED|95.0|2.234|4.095|||Mixed Models Analysis|||Cycle 1 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).||4.095|2.234|<.0001
72360380|NCT00083889|144232508|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.205|||<|0.0001|TWO_SIDED|95.0|2.318|4.092|||Mixed Models Analysis|||Cycle 1 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).||4.092|2.318|<.0001
72360381|NCT00083889|144232508|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.228|||<|0.0001|TWO_SIDED|95.0|2.358|4.097|||Mixed Models Analysis|||Cycle 2 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects)||4.097|2.358|<.0001
72360382|NCT00083889|144232508|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.268|||<|0.0001|TWO_SIDED|95.0|2.418|4.119|||Mixed Models Analysis|||Cycle 2 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).||4.119|2.418|<.0001
72360383|NCT00083889|144232508|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.291|||<|0.0001|TWO_SIDED|95.0|2.443|4.139|||Mixed Models Analysis|||Cycle 3 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).||4.139|2.443|<.0001
72360384|NCT00083889|144232508|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.331|||<|0.0001|TWO_SIDED|95.0|2.474|4.189|||Mixed Models Analysis|||Cycle 3 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).||4.189|2.474|<.0001
72360385|NCT00083889|144232508|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.354|||<|0.0001||95.0|2.484|4.224|||Mixed Models Analysis|||Cycle 4 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).||4.224|2.484|<.0001
72360386|NCT00083889|144232508|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.395|||<|0.0001|TWO_SIDED|95.0|2.489|4.3|||Mixed Models Analysis|||Cycle 4 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).||4.300|2.489|<.0001
72360387|NCT00083889|144232508|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.417|||<|0.0001|TWO_SIDED|95.0|2.486|4.348|||Mixed Models Analysis|||Cycle 5 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).||4.348|2.486|<.0001
72360388|NCT00083889|144232508|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.458|||<|0.0001|TWO_SIDED|95.0|2.469|4.446|||Mixed Models Analysis|||Cycle 5 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).||4.446|2.469|<.0001
72360389|NCT00083889|144232508|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.48|||<|0.0001|TWO_SIDED|95.0|2.455|4.505|||Mixed Models Analysis|||Cycle 6 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).||4.505|2.455|<.0001
72360390|NCT00083889|144232508|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.521|||<|0.0001|TWO_SIDED|95.0|2.422|4.62|||Mixed Models Analysis|||Cycle 6 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).||4.620|2.422|<.0001
72360391|NCT00083889|144232508|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.543|||<|0.0001|TWO_SIDED|95.0|2.399|4.687|||Mixed Models Analysis|||Cycle 7 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).||4.687|2.399|<.0001
72360392|NCT00083889|144232508|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.584|||<|0.0001||95.0|2.354|4.814|||Mixed Models Analysis|||Cycle 7 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects)||4.814|2.354|<.0001
72360393|NCT00083889|144232508|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.606|||<|0.0001|TWO_SIDED|95.0|2.326|4.887|||Mixed Models Analysis|||Cycle 8 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).||4.887|2.326|<.0001
72360394|NCT00083889|144232508|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.647|||<|0.0001|TWO_SIDED|95.0|2.272|5.022|||Mixed Models Analysis|||Cycle 8 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).||5.022|2.272|<.0001
72360395|NCT00083889|144232508|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.669|||<|0.0001|TWO_SIDED|95.0|2.24|5.099|||Mixed Models Analysis|||Cycle 9 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).||5.099|2.240|<.0001
72360396|NCT00083889|144232508|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.71|||<|0.0001|TWO_SIDED|95.0|2.18|5.24|||Mixed Models Analysis|||Cycle 9 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).||5.240|2.180|<.0001
72360397|NCT00083889|144232508|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.733|||<|0.0001|TWO_SIDED|95.0|2.145|5.32|||Mixed Models Analysis|||Cycle 10 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).||5.320|2.145|<.0001
72360398|NCT00083889|144232508|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.773|||<|0.0001|TWO_SIDED|95.0|2.08|5.466|||Mixed Models Analysis|||Cycle 10 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).||5.466|2.080|<.0001
72360399|NCT00083889|144232508|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.796|||<|0.0001|TWO_SIDED|95.0|2.043|5.548|||Mixed Models Analysis|||Cycle 11 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).||5.548|2.043|<.0001
72360400|NCT00083889|144232508|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.836|||<|0.0001|TWO_SIDED|95.0|1.975|5.698|||Mixed Models Analysis|||Cycle 11 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).||5.698|1.975|<.0001
72360401|NCT00083889|144232508|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.859|||<|0.0001|TWO_SIDED|95.0|1.936|5.781|||Mixed Models Analysis|||Cycle 12 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).||5.781|1.936|<.0001
72360402|NCT00083889|144232508|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.899||||0.0002|TWO_SIDED|95.0|1.866|5.933|||Mixed Models Analysis|||Cycle 12 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).||5.933|1.866|0.0002
72360403|NCT00083889|144232508|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.922||||0.0002|TWO_SIDED|95.0|1.826|6.018|||Mixed Models Analysis|||Cycle 13 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).||6.018|1.826|0.0002
72360404|NCT00083889|144232508|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.962||||0.0004|TWO_SIDED|95.0|1.753|6.172|||Mixed Models Analysis|||Cycle 13 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).||6.172|1.753|0.0004
72360405|NCT00083889|144232508|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.985||||0.0006||95.0|1.712|6.258|||Mixed Models Analysis|||Cycle 14 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).||6.258|1.712|0.0006
72360406|NCT00083889|144232508|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.026||||0.001|TWO_SIDED|95.0|1.638|6.413|||Mixed Models Analysis|||Cycle 14 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).||6.413|1.638|0.0010
72360407|NCT00083889|144232508|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.048||||0.0012|TWO_SIDED|95.0|1.597|6.5|||Mixed Models Analysis|||Cycle 15 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).||6.500|1.597|0.0012
72360408|NCT00083889|144232508|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.089||||0.0018|TWO_SIDED|95.0|1.521|6.656|||Mixed Models Analysis|||Cycle 15 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).||6.656|1.521|0.0018
72360409|NCT00083889|144232508|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.111||||0.0022|TWO_SIDED|95.0|1.479|6.743|||Mixed Models Analysis|||Cycle 16 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).||6.743|1.479|0.0022
72360410|NCT00083889|144232508|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.152||||0.0031|TWO_SIDED|95.0|1.403|6.901|||Mixed Models Analysis|||Cycle 16 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).||6.901|1.403|0.0031
72360411|NCT00083889|144232508|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.174||||0.0037||95.0|1.36|6.988|||Mixed Models Analysis|||Cycle 17 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).||6.988|1.360|0.0037
72360412|NCT00083889|144232508|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.215||||0.0048|TWO_SIDED|95.0|1.283|7.147|||Mixed Models Analysis|||Cycle 17 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).||7.147|1.283|0.0048
72360413|NCT00083889|144232508|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.237||||0.0056|TWO_SIDED|95.0|1.24|7.235|||Mixed Models Analysis|||Cycle 18 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).||7.235|1.240|0.0056
72360414|NCT00083889|144232508|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.278||||0.0071|TWO_SIDED|95.0|1.162|7.394|||Mixed Models Analysis|||Cycle 18 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).||7.394|1.162|0.0071
72360415|NCT00083889|144232508|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.3||||0.0081|TWO_SIDED|95.0|1.119|7.482|||Mixed Models Analysis|||Cycle 19 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).||7.482|1.119|0.0081
72360416|NCT00083889|144232508|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.341||||0.0099|TWO_SIDED|95.0|1.041|7.642|||Mixed Models Analysis|||Cycle 19 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).||7.642|1.041|0.0099
72360417|NCT00083889|144232508|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.364||||0.0111|TWO_SIDED|95.0|0.997|7.73|||Mixed Models Analysis|||Cycle 20 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).||7.730|0.997|0.0111
72360418|NCT00083889|144232508|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.404||||0.0133|TWO_SIDED|95.0|0.918|7.89|||Mixed Models Analysis|||Cycle 20 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).||7.890|0.918|0.0133
72360419|NCT00083889|144232509|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.5404|||<|0.0001|TWO_SIDED|95.0|0.4532|0.6444||p-value is from 2-sided, unstratified test.|Log Rank||Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of SU011248: a hazard ratio greater than 1 indicates a reduction in favor of IFN-a.|Unstratified analysis: Hazard Ratio (SU011248 vs IFN-α).||0.6444|0.4532|<0.0001
72360420|NCT00083889|144232509|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.5418|||<|1e-05|TWO_SIDED|95.0|0.4536|0.6473||p-value is from 2-sided, stratified test. Stratification factors are: Lactic Dehydrogenase (LDH) \> or \<= 1.5 x upper limit of normal, Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1, and absence or presence of prior nephrectomy.|Log Rank||Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of SU011248: a hazard ratio greater than 1 indicates a reduction in favor of IFN-a.|Stratified analysis: Hazard Ratio (SU011248 vs IFN-α).||0.6473|0.4536|<.00001
72360421|NCT00083889|144232510|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.486|||<|0.0001|TWO_SIDED|95.0|3.852|7.119|||Mixed Models Analysis|||Cycle 1 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline Functional Assessment of Cancer Therapy-General (FACT-G) baseline score (intercept and time since randomization are included as random effects).||7.119|3.852|<.0001
72360422|NCT00083889|144232510|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.535|||<|0.0001|TWO_SIDED|95.0|3.955|7.115|||Mixed Models Analysis|||Cycle 1 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).||7.115|3.955|<.0001
72360423|NCT00083889|144232510|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.562|||<|0.0001|TWO_SIDED|95.0|4.0|7.124|||Mixed Models Analysis|||Cycle 2 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).||7.124|4.000|<.0001
72360424|NCT00083889|144232510|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.611|||<|0.0001|TWO_SIDED|95.0|4.061|7.162|||Mixed Models Analysis|||Cycle 2 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).||7.162|4.061|<.0001
72360425|NCT00083889|144232510|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.639|||<|0.0001|TWO_SIDED|95.0|4.083|7.195|||Mixed Models Analysis|||Cycle 3 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).||7.195|4.083|<.0001
72360426|NCT00083889|144232510|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.688|||<|0.0001|TWO_SIDED|95.0|4.1|7.276|||Mixed Models Analysis|||Cycle 3 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).||7.276|4.100|<.0001
72360427|NCT00083889|144232510|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.715|||<|0.0001|TWO_SIDED|95.0|4.098|7.333|||Mixed Models Analysis|||Cycle 4 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).||7.333|4.098|<.0001
72360428|NCT00083889|144232510|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.764|||<|0.0001|TWO_SIDED|95.0|4.075|7.454|||Mixed Models Analysis|||Cycle 4 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).||7.454|4.075|<.0001
72360429|NCT00083889|144232510|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.792|||<|0.0001|TWO_SIDED|95.0|4.053|7.531|||Mixed Models Analysis|||Cycle 5 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).||7.531|4.053|<.0001
72360430|NCT00083889|144232510|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.841|||<|0.0001|TWO_SIDED|95.0|3.998|7.684|||Mixed Models Analysis|||Cycle 5 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).||7.684|3.998|<.0001
72360431|NCT00083889|144232510|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.868|||<|0.0001|TWO_SIDED|95.0|3.96|7.777|||Mixed Models Analysis|||Cycle 6 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).||7.777|3.960|<.0001
72360432|NCT00083889|144232510|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.917|||<|0.0001|TWO_SIDED|95.0|3.88|7.955|||Mixed Models Analysis|||Cycle 6 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).||7.955|3.880|<.0001
72360433|NCT00083889|144232510|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.945|||<|0.0001|TWO_SIDED|95.0|3.83|8.06|||Mixed Models Analysis|||Cycle 7 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).||8.060|3.830|<.0001
72360434|NCT00083889|144232510|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.994|||<|0.0001|TWO_SIDED|95.0|3.731|8.257|||Mixed Models Analysis|||Cycle 7 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).||8.257|3.731|<.0001
72360435|NCT00083889|144232510|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.021|||<|0.0001|TWO_SIDED|95.0|3.672|8.37|||Mixed Models Analysis|||Cycle 8 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).||8.370|3.672|<.0001
72360436|NCT00083889|144232510|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.071|||<|0.0001|TWO_SIDED|95.0|3.56|8.581|||Mixed Models Analysis|||Cycle 8 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).||8.581|3.560|<.0001
72360437|NCT00083889|144232510|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.098|||<|0.0001|TWO_SIDED|95.0|3.495|8.701|||Mixed Models Analysis|||Cycle 9 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).||8.701|3.495|<.0001
72360438|NCT00083889|144232510|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.147|||<|0.0001|TWO_SIDED|95.0|3.373|8.921|||Mixed Models Analysis|||Cycle 9 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).||8.921|3.373|<.0001
72360439|NCT00083889|144232510|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.174|||<|0.0001|TWO_SIDED|95.0|3.303|9.045|||Mixed Models Analysis|||Cycle 10 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).||9.045|3.303|<.0001
72360440|NCT00083889|144232510|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.224|||<|0.0001|TWO_SIDED|95.0|3.174|9.273|||Mixed Models Analysis|||Cycle 10 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).||9.273|3.174|<.0001
72360441|NCT00083889|144232510|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.251||||0.0001|TWO_SIDED|95.0|3.101|9.401|||Mixed Models Analysis|||Cycle 11 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).||9.401|3.101|0.0001
72360442|NCT00083889|144232510|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.3||||0.0002|TWO_SIDED|95.0|2.966|9.634|||Mixed Models Analysis|||Cycle 11 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).||9.634|2.966|0.0002
72360443|NCT00083889|144232510|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.327||||0.0003|TWO_SIDED|95.0|2.89|9.765|||Mixed Models Analysis|||Cycle 12 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).||9.765|2.890|0.0003
72360444|NCT00083889|144232510|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.377||||0.0006|TWO_SIDED|95.0|2.751|10.002|||Mixed Models Analysis|||Cycle 12 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).||10.002|2.751|0.0006
72360445|NCT00083889|144232510|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.404||||0.0008|TWO_SIDED|95.0|2.673|10.135|||Mixed Models Analysis|||Cycle 13 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).||10.135|2.673|0.0008
72360446|NCT00083889|144232510|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.453||||0.0013|TWO_SIDED|95.0|2.53|10.376|||Mixed Models Analysis|||Cycle 13 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).||10.376|2.530|0.0013
72360447|NCT00083889|144232510|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.48||||0.0016|TWO_SIDED|95.0|2.451|10.51|||Mixed Models Analysis|||Cycle 14 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).||10.510|2.451|0.0016
72429367|NCT04102540|144369721|OTHER|In this analysis, our null hypothesis was that the median viral load at baseline/exposure 1 was exactly equivalent to the median viral load following exposure 3 to the intervention.|Median Difference (Net)|-63.0||||0.5971|TWO_SIDED|95.0|-296.1|170.1||The p-value was not adjusted for multiple comparisons and the a priori threshold for significance was alpha = 0.05.|Quantile Regression|||Statistical analysis of viral load between baseline/exposure 1 and exposure 3 to the intervention.|This is the difference in median viral load between baseline/exposure 1 and exposure 3.|170.1|-296.1|0.5971
72360448|NCT00083889|144232510|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.53||||0.0025|TWO_SIDED|95.0|2.306|10.754|||Mixed Models Analysis|||Cycle 14 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).||10.754|2.306|0.0025
72360449|NCT00083889|144232510|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.557||||0.003|TWO_SIDED|95.0|2.224|10.889|||Mixed Models Analysis|||Cycle 15 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).||10.889|2.224|0.0030
72360450|NCT00083889|144232510|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.606||||0.0043|TWO_SIDED|95.0|2.077|11.135|||Mixed Models Analysis|||Cycle 15 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).||11.135|2.077|0.0043
72360451|NCT00083889|144232510|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.634||||0.0051|TWO_SIDED|95.0|1.995|11.272|||Mixed Models Analysis|||Cycle 16 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).||11.272|1.995|0.0051
72360452|NCT00083889|144232510|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.683||||0.0068|TWO_SIDED|95.0|1.847|11.519|||Mixed Models Analysis|||Cycle 16 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).||11.519|1.847|0.0068
72360453|NCT00083889|144232510|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.71||||0.0079|TWO_SIDED|95.0|1.764|11.657|||Mixed Models Analysis|||Cycle 17 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).||11.657|1.764|0.0079
72360454|NCT00083889|144232510|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.759||||0.01|TWO_SIDED|95.0|1.613|11.905|||Mixed Models Analysis|||Cycle 17 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).||11.905|1.613|0.0100
72360455|NCT00083889|144232510|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.787||||0.0114|TWO_SIDED|95.0|1.53|12.043|||Mixed Models Analysis|||Cycle 18 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).||12.043|1.530|0.0114
72360456|NCT00083889|144232510|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.836||||0.0141|TWO_SIDED|95.0|1.378|12.293|||Mixed Models Analysis|||Cycle 18 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).||12.293|1.378|0.0141
72360457|NCT00083889|144232510|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.863||||0.0157|TWO_SIDED|95.0|1.294|12.432|||Mixed Models Analysis|||Cycle 19 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).||12.432|1.294|0.0157
72360458|NCT00083889|144232510|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.912||||0.0189|TWO_SIDED|95.0|1.142|12.683|||Mixed Models Analysis|||Cycle 19 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).||12.683|1.142|0.0189
72360459|NCT00083889|144232510|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.94||||0.0208|TWO_SIDED|95.0|1.057|12.822|||Mixed Models Analysis|||Cycle 20 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).||12.822|1.057|0.0208
72360460|NCT00083889|144232510|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.989||||0.0244|TWO_SIDED|95.0|0.904|13.074|||Mixed Models Analysis|||Cycle 20 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).||13.074|0.904|0.0244
72360461|NCT00083889|144232511|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.459|||<|0.0001|TWO_SIDED|95.0|0.805|2.114|||Mixed Models Analysis|||Cycle 1 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline Functional Assessment of Cancer Therapy-General (FACT-G) Physical Well Being (PWB) subscale baseline score (intercept and time since randomization are included as random effects).||2.114|0.805|<.0001
72360462|NCT00083889|144232511|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.453|||<|0.0001|TWO_SIDED|95.0|0.827|2.079|||Mixed Models Analysis|||Cycle 1 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).||2.079|0.827|<.0001
72360463|NCT00083889|144232511|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.45|||<|0.0001|TWO_SIDED|95.0|0.837|2.063|||Mixed Models Analysis|||Cycle 2 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).||2.063|0.837|<.0001
72360464|NCT00083889|144232511|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.444|||<|0.0001|TWO_SIDED|95.0|0.847|2.041|||Mixed Models Analysis|||Cycle 2 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).||2.041|0.847|<.0001
72360465|NCT00083889|144232511|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.44|||<|0.0001|TWO_SIDED|95.0|0.848|2.032|||Mixed Models Analysis|||Cycle 3 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).||2.032|0.848|<.0001
72360466|NCT00083889|144232511|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.434|||<|0.0001|TWO_SIDED|95.0|0.844|2.024|||Mixed Models Analysis|||Cycle 3 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).||2.024|0.844|<.0001
72360467|NCT00083889|144232511|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.431|||<|0.0001|TWO_SIDED|95.0|0.838|2.023|||Mixed Models Analysis|||Cycle 4 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).||2.023|0.838|<.0001
72360468|NCT00083889|144232511|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.424|||<|0.0001|TWO_SIDED|95.0|0.819|2.029|||Mixed Models Analysis|||Cycle 4 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).||2.029|0.819|<.0001
72360469|NCT00083889|144232511|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.421|||<|0.0001|TWO_SIDED|95.0|0.805|2.037|||Mixed Models Analysis|||Cycle 5 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).||2.037|0.805|<.0001
72360470|NCT00083889|144232511|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.415|||<|0.0001|TWO_SIDED|95.0|0.774|2.056|||Mixed Models Analysis|||Cycle 5 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).||2.056|0.774|<.0001
72360471|NCT00083889|144232511|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.411|||<|0.0001|TWO_SIDED|95.0|0.753|2.069|||Mixed Models Analysis|||Cycle 6 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).||2.069|0.753|<.0001
72360472|NCT00083889|144232511|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.405|||<|0.0001|TWO_SIDED|95.0|0.711|2.099|||Mixed Models Analysis|||Cycle 6 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).||2.099|0.711|<.0001
72360473|NCT00083889|144232511|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.402||||0.0001|TWO_SIDED|95.0|0.685|2.119|||Mixed Models Analysis|||Cycle 7 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).||2.119|0.685|0.0001
72360474|NCT00083889|144232511|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.396||||0.0003|TWO_SIDED|95.0|0.634|2.157|||Mixed Models Analysis|||Cycle 7 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).||2.157|0.634|0.0003
72360475|NCT00083889|144232511|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.392||||0.0005|TWO_SIDED|95.0|0.604|2.18|||Mixed Models Analysis|||Cycle 8 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).||2.180|0.604|0.0005
72360476|NCT00083889|144232511|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.386||||0.0012|TWO_SIDED|95.0|0.547|2.225|||Mixed Models Analysis|||Cycle 8 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).||2.225|0.547|0.0012
72360477|NCT00083889|144232511|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.383||||0.0018|TWO_SIDED|95.0|0.514|2.252|||Mixed Models Analysis|||Cycle 9 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).||2.252|0.514|0.0018
72360478|NCT00083889|144232511|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.376||||0.0035|TWO_SIDED|95.0|0.451|2.301|||Mixed Models Analysis|||Cycle 9 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).||2.301|0.451|0.0035
72360479|NCT00083889|144232511|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.373||||0.0049|TWO_SIDED|95.0|0.416|2.33|||Mixed Models Analysis|||Cycle 10 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).||2.330|0.416|0.0049
72360480|NCT00083889|144232511|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.367||||0.0084|TWO_SIDED|95.0|0.35|2.383|||Mixed Models Analysis|||Cycle 10 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).||2.383|0.350|0.0084
72360481|NCT00083889|144232511|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.363||||0.011|TWO_SIDED|95.0|0.313|2.414|||Mixed Models Analysis|||Cycle 11 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).||2.414|0.313|0.0110
72360482|NCT00083889|144232511|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.357||||0.0168|TWO_SIDED|95.0|0.245|2.47|||Mixed Models Analysis|||Cycle 11 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).||2.470|0.245|0.0168
72360483|NCT00083889|144232511|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.354||||0.0208|TWO_SIDED|95.0|0.206|2.501|||Mixed Models Analysis|||Cycle 12 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).||2.501|0.206|0.0208
72360484|NCT00083889|144232511|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.348||||0.0293|TWO_SIDED|95.0|0.136|2.559|||Mixed Models Analysis|||Cycle 12 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).||2.559|0.136|0.0293
72360485|NCT00083889|144232511|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.344||||0.0348|TWO_SIDED|95.0|0.096|2.592|||Mixed Models Analysis|||Cycle 13 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).||2.592|0.096|0.0348
72360486|NCT00083889|144232511|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.338||||0.0459|TWO_SIDED|95.0|0.024|2.652|||Mixed Models Analysis|||Cycle 13 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).||2.652|0.024|0.0459
72360487|NCT00083889|144232511|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.335||||0.0528|TWO_SIDED|95.0|-0.016|2.685|||Mixed Models Analysis|||Cycle 14 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).||2.685|-0.016|0.0528
72360488|NCT00083889|144232511|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.328||||0.0663|TWO_SIDED|95.0|-0.09|2.746|||Mixed Models Analysis|||Cycle 14 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).||2.746|-0.090|0.0663
72360489|NCT00083889|144232511|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.325||||0.0744|TWO_SIDED|95.0|-0.131|2.78|||Mixed Models Analysis|||Cycle 15 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).||2.780|-0.131|0.0744
72429368|NCT04102540|144369722|OTHER|In this analysis, our null hypothesis was that the median HIV-related knowledge score at baseline/exposure 1 was exactly equivalent to the median HIV-related knowledge score following exposure 2 to the intervention.|Median Difference (Net)|2.12|||<|0.0001|TWO_SIDED|95.0|1.2|3.0||The p-value was not adjusted for multiple comparisons and the a priori threshold for significance was alpha = 0.05.|Quantile Regression|Random intercepts for subjects were included in the model.|This is the difference in median HIV-Related knowledge scores between baseline/exposure 1 and exposure 2.|Statistical analysis of HIV-related knowledge scores between baseline/exposure 1 and exposure 2 to the intervention.||3.0|1.2|<.0001
72360490|NCT00083889|144232511|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.319||||0.0898|TWO_SIDED|95.0|-0.205|2.842|||Mixed Models Analysis|||Cycle 15 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).||2.842|-0.205|0.0898
72360491|NCT00083889|144232511|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.315||||0.0988|TWO_SIDED|95.0|-0.246|2.877|||Mixed Models Analysis|||Cycle 16 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).||2.877|-0.246|0.0988
72360492|NCT00083889|144232511|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.309||||0.1156|TWO_SIDED|95.0|-0.321|2.94|||Mixed Models Analysis|||Cycle 16 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).||2.940|-0.321|0.1156
72360493|NCT00083889|144232511|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.306||||0.1252|TWO_SIDED|95.0|-0.363|2.975|||Mixed Models Analysis|||Cycle 17 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).||2.975|-0.363|0.1252
72360494|NCT00083889|144232511|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.3||||0.1429|TWO_SIDED|95.0|-0.439|3.038|||Mixed Models Analysis|||Cycle 17 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).||3.038|-0.439|0.1429
72360495|NCT00083889|144232511|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.296||||0.1529|TWO_SIDED|95.0|-0.481|3.074|||Mixed Models Analysis|||Cycle 18 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).||3.074|-0.481|0.1529
72360496|NCT00083889|144232511|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.29||||0.1711|TWO_SIDED|95.0|-0.558|3.138|||Mixed Models Analysis|||Cycle 18 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).||3.138|-0.558|0.1711
72360497|NCT00083889|144232511|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.287||||0.1813|TWO_SIDED|95.0|-0.6|3.173|||Mixed Models Analysis|||Cycle 19 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).||3.173|-0.600|0.1813
72360498|NCT00083889|144232511|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.28||||0.1998|TWO_SIDED|95.0|-0.677|3.238|||Mixed Models Analysis|||Cycle 19 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).||3.238|-0.677|0.1998
72360499|NCT00083889|144232511|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.277||||0.21|TWO_SIDED|95.0|-0.72|3.273|||Mixed Models Analysis|||Cycle 20 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).||3.273|-0.720|0.2100
72360500|NCT00083889|144232511|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.271||||0.2283|TWO_SIDED|95.0|-0.797|3.338|||Mixed Models Analysis|||Cycle 20 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).||3.338|-0.797|0.2283
72360501|NCT00083889|144232512|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.214|||<|0.0001|TWO_SIDED|95.0|0.719|1.708|||Mixed Models Analysis|||Cycle 1 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline Functional Assessment of Cancer Therapy-General (FACT-G) Social/Family Well Being (SWB) subscale baseline score (intercept and time since randomization are included as random effects).||1.708|0.719|<.0001
72360502|NCT00083889|144232512|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.216|||<|0.0001|TWO_SIDED|95.0|0.729|1.703|||Mixed Models Analysis|||Cycle 1 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).||1.703|0.729|<.0001
72360503|NCT00083889|144232512|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.217|||<|0.0001|TWO_SIDED|95.0|0.731|1.704|||Mixed Models Analysis|||Cycle 2 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).||1.704|0.731|<.0001
72360504|NCT00083889|144232512|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.22|||<|0.0001|TWO_SIDED|95.0|0.73|1.71|||Mixed Models Analysis|||Cycle 2 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).||1.710|0.730|<.0001
72360505|NCT00083889|144232512|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.221|||<|0.0001|TWO_SIDED|95.0|0.727|1.716|||Mixed Models Analysis|||Cycle 3 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).||1.716|0.727|<.0001
72360506|NCT00083889|144232512|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.224|||<|0.0001|TWO_SIDED|95.0|0.716|1.732|||Mixed Models Analysis|||Cycle 3 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).||1.732|0.716|<.0001
72360507|NCT00083889|144232512|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.225|||<|0.0001|TWO_SIDED|95.0|0.707|1.744|||Mixed Models Analysis|||Cycle 4 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).||1.744|0.707|<.0001
72360508|NCT00083889|144232512|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.228|||<|0.0001|TWO_SIDED|95.0|0.687|1.769|||Mixed Models Analysis|||Cycle 4 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).||1.769|0.687|<.0001
72360509|NCT00083889|144232512|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.229|||<|0.0001|TWO_SIDED|95.0|0.673|1.785|||Mixed Models Analysis|||Cycle 5 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).||1.785|0.673|<.0001
72360510|NCT00083889|144232512|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.232|||<|0.0001|TWO_SIDED|95.0|0.646|1.818|||Mixed Models Analysis|||Cycle 5 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).||1.818|0.646|<.0001
72360511|NCT00083889|144232512|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.233|||<|0.0001|TWO_SIDED|95.0|0.629|1.838|||Mixed Models Analysis|||Cycle 6 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).||1.838|0.629|<.0001
72360512|NCT00083889|144232512|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.236||||0.0002|TWO_SIDED|95.0|0.595|1.876|||Mixed Models Analysis|||Cycle 6 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).||1.876|0.595|0.0002
72360513|NCT00083889|144232512|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.237||||0.0003|TWO_SIDED|95.0|0.575|1.899|||Mixed Models Analysis|||Cycle 7 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).||1.899|0.575|0.0003
72360514|NCT00083889|144232512|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.24||||0.0005|TWO_SIDED|95.0|0.537|1.942|||Mixed Models Analysis|||Cycle 7 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).||1.942|0.537|0.0005
72360515|NCT00083889|144232512|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.241||||0.0008|TWO_SIDED|95.0|0.515|1.967|||Mixed Models Analysis|||Cycle 8 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).||1.967|0.515|0.0008
72360516|NCT00083889|144232512|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.244||||0.0015|TWO_SIDED|95.0|0.474|2.013|||Mixed Models Analysis|||Cycle 8 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).||2.013|0.474|0.0015
72360517|NCT00083889|144232512|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.245||||0.0021|TWO_SIDED|95.0|0.45|2.04|||Mixed Models Analysis|||Cycle 9 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).||2.040|0.450|0.0021
72360518|NCT00083889|144232512|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.248||||0.0037|TWO_SIDED|95.0|0.406|2.089|||Mixed Models Analysis|||Cycle 9 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).||2.089|0.406|0.0037
72360519|NCT00083889|144232512|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.249||||0.0048|TWO_SIDED|95.0|0.382|2.116|||Mixed Models Analysis|||Cycle 10 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).||2.116|0.382|0.0048
72360520|NCT00083889|144232512|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.251||||0.0074|TWO_SIDED|95.0|0.336|2.167|||Mixed Models Analysis|||Cycle 10 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).||2.167|0.336|0.0074
72360521|NCT00083889|144232512|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.253||||0.0092|TWO_SIDED|95.0|0.31|2.196|||Mixed Models Analysis|||Cycle 11 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).||2.196|0.310|0.0092
72360522|NCT00083889|144232512|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.255||||0.0132|TWO_SIDED|95.0|0.262|2.248|||Mixed Models Analysis|||Cycle 11 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).||2.248|0.262|0.0132
72360523|NCT00083889|144232512|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.257||||0.0159|TWO_SIDED|95.0|0.236|2.278|||Mixed Models Analysis|||Cycle 12 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).||2.278|0.236|0.0159
72360524|NCT00083889|144232512|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.259||||0.0213|TWO_SIDED|95.0|0.187|2.332|||Mixed Models Analysis|||Cycle 12 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).||2.332|0.187|0.0213
72360525|NCT00083889|144232512|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.261||||0.0248|TWO_SIDED|95.0|0.16|2.362|||Mixed Models Analysis|||Cycle 13 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).||2.362|0.160|0.0248
72360526|NCT00083889|144232512|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.263||||0.0318|TWO_SIDED|95.0|0.11|2.416|||Mixed Models Analysis|||Cycle 13 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).||2.416|0.110|0.0318
72360527|NCT00083889|144232512|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.265||||0.036|TWO_SIDED|95.0|0.083|2.447|||Mixed Models Analysis|||Cycle 14 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).||2.447|0.083|0.0360
72360528|NCT00083889|144232512|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.267||||0.0443|TWO_SIDED|95.0|0.032|2.502|||Mixed Models Analysis|||Cycle 14 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).||2.502|0.032|0.0443
72360529|NCT00083889|144232512|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.269||||0.0493|TWO_SIDED|95.0|0.004|2.533|||Mixed Models Analysis|||Cycle 15 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).||2.533|0.004|0.0493
72360530|NCT00083889|144232512|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.271||||0.0587|TWO_SIDED|95.0|-0.047|2.589|||Mixed Models Analysis|||Cycle 15 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).||2.589|-0.047|0.0587
72360531|NCT00083889|144232512|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.273||||0.0642|TWO_SIDED|95.0|-0.075|2.62|||Mixed Models Analysis|||Cycle 16 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).||2.620|-0.075|0.0642
72360532|NCT00083889|144232512|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.275||||0.0746|TWO_SIDED|95.0|-0.127|2.677|||Mixed Models Analysis|||Cycle 16 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).||2.677|-0.127|0.0746
72360533|NCT00083889|144232512|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.276||||0.0806|TWO_SIDED|95.0|-0.155|2.708|||Mixed Models Analysis|||Cycle 17 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).||2.708|-0.155|0.0806
72360534|NCT00083889|144232512|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.279||||0.0917|TWO_SIDED|95.0|-0.207|2.765|||Mixed Models Analysis|||Cycle 17 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).||2.765|-0.207|0.0917
72360535|NCT00083889|144232512|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.28||||0.098|TWO_SIDED|95.0|-0.236|2.797|||Mixed Models Analysis|||Cycle 18 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).||2.797|-0.236|0.0980
72360536|NCT00083889|144232512|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.283||||0.1095|TWO_SIDED|95.0|-0.288|2.854|||Mixed Models Analysis|||Cycle 18 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).||2.854|-0.288|0.1095
72360537|NCT00083889|144232512|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.284||||0.1161|TWO_SIDED|95.0|-0.318|2.886|||Mixed Models Analysis|||Cycle 19 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).||2.886|-0.318|0.1161
72360538|NCT00083889|144232512|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.287||||0.128|TWO_SIDED|95.0|-0.37|2.944|||Mixed Models Analysis|||Cycle 19 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).||2.944|-0.370|0.1280
72360539|NCT00083889|144232512|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.288||||0.1346|TWO_SIDED|95.0|-0.399|2.976|||Mixed Models Analysis|||Cycle 20 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).||2.976|-0.399|0.1346
72360540|NCT00083889|144232512|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.291||||0.1466|TWO_SIDED|95.0|-0.452|3.034|||Mixed Models Analysis|||Cycle 20 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).||3.034|-0.452|0.1466
72360541|NCT00083889|144232513|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.929||||0.0001|TWO_SIDED|95.0|0.46|1.398|||Mixed Models Analysis|||Cycle 1 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline Functional Assessment of Cancer Therapy-General (FACT-G) Emotional Well Being (EWB) subscale baseline score (intercept and time since randomization are included as random effects).||1.398|0.460|0.0001
72360542|NCT00083889|144232513|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.922|||<|0.0001||95.0|0.469|1.375|||Mixed Models Analysis|||Cycle 1 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)||1.375|0.469|<.0001
72360543|NCT00083889|144232513|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.918|||<|0.0001||95.0|0.471|1.365|||Mixed Models Analysis|||Cycle 2 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)||1.365|0.471|<.0001
72360544|NCT00083889|144232513|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.911|||<|0.0001||95.0|0.469|1.352|||Mixed Models Analysis|||Cycle 2 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)||1.352|0.469|<.0001
72360545|NCT00083889|144232513|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.907|||<|0.0001||95.0|0.466|1.348|||Mixed Models Analysis|||Cycle 3 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)||1.348|0.466|<.0001
72360546|NCT00083889|144232513|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.899|||<|0.0001||95.0|0.453|1.345|||Mixed Models Analysis|||Cycle 3 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)||1.345|0.453|<.0001
72360547|NCT00083889|144232513|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.895||||0.0001||95.0|0.444|1.347|||Mixed Models Analysis|||Cycle 4 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)||1.347|0.444|0.0001
72360548|NCT00083889|144232513|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.888||||0.0002||95.0|0.421|1.355|||Mixed Models Analysis|||Cycle 4 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)||1.355|0.421|0.0002
72360549|NCT00083889|144232513|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.884||||0.0003||95.0|0.406|1.362|||Mixed Models Analysis|||Cycle 5 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)||1.362|0.406|0.0003
72360550|NCT00083889|144232513|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.877||||0.0006||95.0|0.375|1.379|||Mixed Models Analysis|||Cycle 5 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)||1.379|0.375|0.0006
72360551|NCT00083889|144232513|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.873||||0.0009||95.0|0.356|1.39|||Mixed Models Analysis|||Cycle 6 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)||1.390|0.356|0.0009
72360552|NCT00083889|144232513|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.866||||0.002||95.0|0.318|1.414|||Mixed Models Analysis|||Cycle 6 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)||1.414|0.318|0.0020
72360553|NCT00083889|144232513|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.862||||0.0029||95.0|0.295|1.428|||Mixed Models Analysis|||Cycle 7 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)||1.428|0.295|0.0029
72360554|NCT00083889|144232513|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.854||||0.0055||95.0|0.251|1.457|||Mixed Models Analysis|||Cycle 7 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)||1.457|0.251|0.0055
72360555|NCT00083889|144232513|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.85||||0.0076||95.0|0.226|1.475|||Mixed Models Analysis|||Cycle 8 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)||1.475|0.226|0.0076
72360556|NCT00083889|144232513|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.843||||0.0129||95.0|0.179|1.508|||Mixed Models Analysis|||Cycle 8 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)||1.508|0.179|0.0129
72360557|NCT00083889|144232513|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.839||||0.0168||95.0|0.151|1.527|||Mixed Models Analysis|||Cycle 9 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)||1.527|0.151|0.0168
72360558|NCT00083889|144232513|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.832||||0.0257||95.0|0.101|1.563|||Mixed Models Analysis|||Cycle 9 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)||1.563|0.101|0.0257
72360559|NCT00083889|144232513|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.828||||0.0318||95.0|0.072|1.583|||Mixed Models Analysis|||Cycle 10 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)||1.583|0.072|0.0318
72360560|NCT00083889|144232513|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.821||||0.0447||95.0|0.019|1.622|||Mixed Models Analysis|||Cycle 10 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)||1.622|0.019|0.0447
72360561|NCT00083889|144232513|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.817||||0.0529||95.0|-0.01|1.643|||Mixed Models Analysis|||Cycle 11 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)||1.643|-0.010|0.0529
72360562|NCT00083889|144232513|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.809||||0.0696||95.0|-0.065|1.683|||Mixed Models Analysis|||Cycle 11 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)||1.683|-0.065|0.0696
72360563|NCT00083889|144232513|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.805||||0.0797||95.0|-0.095|1.706|||Mixed Models Analysis|||Cycle 12 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)||1.706|-0.095|0.0797
72360564|NCT00083889|144232513|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.798||||0.0994||95.0|-0.151|1.747|||Mixed Models Analysis|||Cycle 12 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)||1.747|-0.151|0.0994
72360565|NCT00083889|144232513|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.794||||0.111||95.0|-0.182|1.77|||Mixed Models Analysis|||Cycle 13 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)||1.770|-0.182|0.1110
72360566|NCT00083889|144232513|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.787||||0.1328||95.0|-0.239|1.813|||Mixed Models Analysis|||Cycle 13 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)||1.813|-0.239|0.1328
72360567|NCT00083889|144232513|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.783||||0.1454||95.0|-0.271|1.836|||Mixed Models Analysis|||Cycle 14 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)||1.836|-0.271|0.1454
72360568|NCT00083889|144232513|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.776||||0.1686||95.0|-0.329|1.88|||Mixed Models Analysis|||Cycle 14 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)||1.880|-0.329|0.1686
72360569|NCT00083889|144232513|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.771||||0.1817||95.0|-0.361|1.904|||Mixed Models Analysis|||Cycle 15 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)||1.904|-0.361|0.1817
72360570|NCT00083889|144232513|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.764||||0.2055||95.0|-0.419|1.948|||Mixed Models Analysis|||Cycle 15 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)||1.948|-0.419|0.2055
72360571|NCT00083889|144232513|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.76||||0.2188||95.0|-0.452|1.972|||Mixed Models Analysis|||Cycle 16 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)||1.972|-0.452|0.2188
72360572|NCT00083889|144232513|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.753||||0.2427||95.0|-0.51|2.016|||Mixed Models Analysis|||Cycle 16 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)||2.016|-0.510|0.2427
72360573|NCT00083889|144232513|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.749||||0.2559||95.0|-0.543|2.041|||Mixed Models Analysis|||Cycle 17 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)||2.041|-0.543|0.2559
72360574|NCT00083889|144232513|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.742||||0.2794||95.0|-0.602|2.086|||Mixed Models Analysis|||Cycle 17 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)||2.086|-0.602|0.2794
72360575|NCT00083889|144232513|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.738||||0.2923||95.0|-0.635|2.111|||Mixed Models Analysis|||Cycle 18 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)||2.111|-0.635|0.2923
72360576|NCT00083889|144232513|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.73||||0.3152||95.0|-0.695|2.156|||Mixed Models Analysis|||Cycle 18 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)||2.156|-0.695|0.3152
72360577|NCT00083889|144232513|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.726||||0.3276||95.0|-0.728|2.181|||Mixed Models Analysis|||Cycle 19 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)||2.181|-0.728|0.3276
72360578|NCT00083889|144232513|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.719||||0.3497||95.0|-0.788|2.227|||Mixed Models Analysis|||Cycle 19 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)||2.227|-0.788|0.3497
72429369|NCT04102540|144369722|OTHER|In this analysis, our null hypothesis was that the median HIV-related knowledge score at baseline/exposure 1 was exactly equivalent to the median HIV-related knowledge score following exposure 3 to the intervention.|Median Difference (Net)|2.0|||<|0.0001|TWO_SIDED|95.0|1.2|2.8||The p-value was not adjusted for multiple comparisons and the a priori threshold for significance was alpha = 0.05.|Quantile Regression|Random intercepts for subjects were included in the model.|This is the difference in median HIV-related knowledge score between baseline/exposure 1 and exposure 3.|Statistical analysis of HIV-related knowledge scores between baseline/exposure 1 and exposure 3 to the intervention.||2.8|1.2|<.0001
72360579|NCT00083889|144232513|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.715||||0.3616||95.0|-0.822|2.252|||Mixed Models Analysis|||Cycle 20 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)||2.252|-0.822|0.3616
72360580|NCT00083889|144232513|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.708||||0.3827||95.0|-0.882|2.298|||Mixed Models Analysis|||Cycle 20 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)||2.298|-0.882|0.3827
72360581|NCT00083889|144232514|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.897|||<|0.0001|TWO_SIDED|95.0|1.261|2.533|||Mixed Models Analysis|||Cycle 1 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline Functional Assessment of Cancer Therapy-General (FACT-G) Functional Well Being (FWB) subscale baseline score (intercept and time since randomization are included as random effects).||2.533|1.261|<.0001
72360582|NCT00083889|144232514|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.924|||<|0.0001||95.0|1.309|2.539|||Mixed Models Analysis|||Cycle 1 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)||2.539|1.309|<.0001
72360583|NCT00083889|144232514|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.939|||<|0.0001||95.0|1.331|2.546|||Mixed Models Analysis|||Cycle 2 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)||2.546|1.331|<.0001
72360584|NCT00083889|144232514|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.965|||<|0.0001||95.0|1.363|2.568|||Mixed Models Analysis|||Cycle 2 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)||2.568|1.363|<.0001
72360585|NCT00083889|144232514|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.98|||<|0.0001||95.0|1.376|2.584|||Mixed Models Analysis|||Cycle 3 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)||2.584|1.376|<.0001
72360586|NCT00083889|144232514|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.007|||<|0.0001||95.0|1.392|2.622|||Mixed Models Analysis|||Cycle 3 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)||2.622|1.392|<.0001
72360587|NCT00083889|144232514|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.022|||<|0.0001||95.0|1.396|2.647|||Mixed Models Analysis|||Cycle 4 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)||2.647|1.396|<.0001
72360588|NCT00083889|144232514|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.048|||<|0.0001||95.0|1.397|2.7|||Mixed Models Analysis|||Cycle 4 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)||2.700|1.397|<.0001
72360589|NCT00083889|144232514|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.063|||<|0.0001||95.0|1.394|2.732|||Mixed Models Analysis|||Cycle 5 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)||2.732|1.394|<.0001
72360590|NCT00083889|144232514|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.09|||<|0.0001||95.0|1.383|2.797|||Mixed Models Analysis|||Cycle 5 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)||2.797|1.383|<.0001
72360591|NCT00083889|144232514|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.105|||<|0.0001||95.0|1.374|2.836|||Mixed Models Analysis|||Cycle 6 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)||2.836|1.374|<.0001
72360592|NCT00083889|144232514|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.132|||<|0.0001||95.0|1.353|2.91|||Mixed Models Analysis|||Cycle 6 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)||2.910|1.353|<.0001
72360593|NCT00083889|144232514|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.146|||<|0.0001||95.0|1.339|2.954|||Mixed Models Analysis|||Cycle 7 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)||2.954|1.339|<.0001
72360594|NCT00083889|144232514|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.173|||<|0.0001||95.0|1.311|3.036|||Mixed Models Analysis|||Cycle 7 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)||3.036|1.311|<.0001
72360595|NCT00083889|144232514|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.188|||<|0.0001||95.0|1.294|3.082|||Mixed Models Analysis|||Cycle 8 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)||3.082|1.294|<.0001
72360596|NCT00083889|144232514|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.215|||<|0.0001||95.0|1.26|3.169|||Mixed Models Analysis|||Cycle 8 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)||3.169|1.260|<.0001
72360597|NCT00083889|144232514|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.23|||<|0.0001||95.0|1.241|3.219|||Mixed Models Analysis|||Cycle 9 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)||3.219|1.241|<.0001
72360598|NCT00083889|144232514|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.256|||<|0.0001||95.0|1.203|3.309|||Mixed Models Analysis|||Cycle 9 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)||3.309|1.203|<.0001
72360599|NCT00083889|144232514|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.271|||<|0.0001||95.0|1.182|3.361|||Mixed Models Analysis|||Cycle 10 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)||3.361|1.182|<.0001
72360600|NCT00083889|144232514|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.298|||<|0.0001||95.0|1.142|3.454|||Mixed Models Analysis|||Cycle 10 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)||3.454|1.142|<.0001
72360601|NCT00083889|144232514|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.313||||0.0001||95.0|1.119|3.507|||Mixed Models Analysis|||Cycle 11 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)||3.507|1.119|0.0001
72360602|NCT00083889|144232514|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.34||||0.0003||95.0|1.076|3.603|||Mixed Models Analysis|||Cycle 11 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)||3.603|1.076|0.0003
72360603|NCT00083889|144232514|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.354||||0.0004||95.0|1.052|3.657|||Mixed Models Analysis|||Cycle 12 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)||3.657|1.052|0.0004
72360604|NCT00083889|144232514|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.381||||0.0007||95.0|1.008|3.754|||Mixed Models Analysis|||Cycle 12 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)||3.754|1.008|0.0007
72360605|NCT00083889|144232514|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.396||||0.0009||95.0|0.983|3.809|||Mixed Models Analysis|||Cycle 13 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)||3.809|0.983|0.0009
72360606|NCT00083889|144232514|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.423||||0.0014||95.0|0.938|3.908|||Mixed Models Analysis|||Cycle 13 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)||3.908|0.938|0.0014
72360607|NCT00083889|144232514|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.438||||0.0017||95.0|0.912|3.963|||Mixed Models Analysis|||Cycle 14 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)||3.963|0.912|0.0017
72360608|NCT00083889|144232514|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.464||||0.0025||95.0|0.866|4.063|||Mixed Models Analysis|||Cycle 14 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)||4.063|0.866|0.0025
72360609|NCT00083889|144232514|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.479||||0.003||95.0|0.84|4.119|||Mixed Models Analysis|||Cycle 15 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)||4.119|0.840|0.0030
72360610|NCT00083889|144232514|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.506||||0.0042||95.0|0.792|4.219|||Mixed Models Analysis|||Cycle 15 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)||4.219|0.792|0.0042
72360611|NCT00083889|144232514|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.521||||0.0049||95.0|0.766|4.275|||Mixed Models Analysis|||Cycle 16 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)||4.275|0.766|0.0049
72360612|NCT00083889|144232514|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.547||||0.0064||95.0|0.718|4.377|||Mixed Models Analysis|||Cycle 16 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)||4.377|0.718|0.0064
72360613|NCT00083889|144232514|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.562||||0.0073||95.0|0.691|4.433|||Mixed Models Analysis|||Cycle 17 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)||4.433|0.691|0.0073
72360614|NCT00083889|144232514|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.589||||0.0091||95.0|0.643|4.535|||Mixed Models Analysis|||Cycle 17 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)||4.535|0.643|0.0091
72360615|NCT00083889|144232514|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.604||||0.0103||95.0|0.616|4.592|||Mixed Models Analysis|||Cycle 18 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)||4.592|0.616|0.0103
72360616|NCT00083889|144232514|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.631||||0.0125||95.0|0.567|4.695|||Mixed Models Analysis|||Cycle 18 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)||4.695|0.567|0.0125
72360617|NCT00083889|144232514|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.645||||0.0138||95.0|0.539|4.752|||Mixed Models Analysis|||Cycle 19 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)||4.752|0.539|0.0138
72360618|NCT00083889|144232514|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.672||||0.0164||95.0|0.49|4.855|||Mixed Models Analysis|||Cycle 19 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)||4.855|0.490|0.0164
72360619|NCT00083889|144232514|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.687||||0.0179||95.0|0.462|4.912|||Mixed Models Analysis|||Cycle 20 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)||4.912|0.462|0.0179
72360620|NCT00083889|144232514|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.714||||0.0208||95.0|0.413|5.015|||Mixed Models Analysis|||Cycle 20 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)||5.015|0.413|0.0208
72360621|NCT00083889|144232515|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.049||||0.0004|TWO_SIDED|95.0|0.022|0.076|||Mixed Models Analysis|||Cycle 1 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EuroQoL Five Dimension (EQ-5D): Health state index baseline score (intercept and time since randomization are included as random effects).||0.076|0.022|0.0004
72429370|NCT04102540|144369724|OTHER|In this analysis, our null hypothesis was that the median self-efficacy to manage HIV scale score at baseline/exposure 1 was exactly equivalent to the median self-efficacy to manage HIV scale score following exposure 2 to the intervention.|Median Difference (Net)|0.01||||0.9879|TWO_SIDED|95.0|-0.7|0.7||The p-value was not adjusted for multiple comparisons and the a priori threshold for significance was alpha = 0.05.|Quantile Regression|Random intercepts for subjects were included in the model.|This is the difference in median self-efficacy to manage HIV scale scores between baseline/exposure 1 and exposure 2.|Statistical analysis of self-efficacy to manage HIV scale score between baseline/exposure 1 and exposure 2 to the intervention.||0.7|-0.7|0.9879
72360622|NCT00083889|144232515|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.048||||0.0003||95.0|0.022|0.075|||Mixed Models Analysis|||Cycle 1 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)||0.075|0.022|0.0003
72360623|NCT00083889|144232515|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.048||||0.0003||95.0|0.022|0.074|||Mixed Models Analysis|||Cycle 2 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)||0.074|0.022|0.0003
72360624|NCT00083889|144232515|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.047||||0.0003||95.0|0.021|0.072|||Mixed Models Analysis|||Cycle 2 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)||0.072|0.021|0.0003
72360625|NCT00083889|144232515|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.046||||0.0004||95.0|0.021|0.072|||Mixed Models Analysis|||Cycle 3 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)||0.072|0.021|0.0004
72360626|NCT00083889|144232515|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.045||||0.0005||95.0|0.02|0.071|||Mixed Models Analysis|||Cycle 3 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)||0.071|0.020|0.0005
72360627|NCT00083889|144232515|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.045||||0.0007||95.0|0.019|0.07|||Mixed Models Analysis|||Cycle 4 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)||0.070|0.019|0.0007
72360628|NCT00083889|144232515|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.044||||0.0011||95.0|0.017|0.07|||Mixed Models Analysis|||Cycle 4 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)||0.070|0.017|0.0011
72360629|NCT00083889|144232515|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.043||||0.0016||95.0|0.016|0.07|||Mixed Models Analysis|||Cycle 5 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)||0.070|0.016|0.0016
72360630|NCT00083889|144232515|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.042||||0.0029||95.0|0.014|0.07|||Mixed Models Analysis|||Cycle 5 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)||0.070|0.014|0.0029
72360631|NCT00083889|144232515|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.042||||0.0041||95.0|0.013|0.07|||Mixed Models Analysis|||Cycle 6 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)||0.070|0.013|0.0041
72360632|NCT00083889|144232515|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.041||||0.0076||95.0|0.011|0.071|||Mixed Models Analysis|||Cycle 6 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)||0.071|0.011|0.0076
72360633|NCT00083889|144232515|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.04||||0.0105||95.0|0.009|0.071|||Mixed Models Analysis|||Cycle 7 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)||0.071|0.009|0.0105
72360634|NCT00083889|144232515|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.039||||0.0179||95.0|0.007|0.072|||Mixed Models Analysis|||Cycle 7 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)||0.072|0.007|0.0179
72360635|NCT00083889|144232515|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.039||||0.0236||95.0|0.005|0.072|||Mixed Models Analysis|||Cycle 8 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)||0.072|0.005|0.0236
72429371|NCT04102540|144369724|OTHER|In this analysis, our null hypothesis was that the median self-efficacy to manage HIV scale score at baseline/exposure 1 was exactly equivalent to the median self-efficacy to manage HIV scale score following exposure 3 to the intervention.|Median Difference (Net)|0.57||||0.155|TWO_SIDED|95.0|-0.2|1.4||The p-value was not adjusted for multiple comparisons and the a priori threshold for significance was alpha = 0.05.|Quantile Regression|Random intercepts for subjects were included in the model.|This is the difference in median self-efficacy to manage HIV scale scores between baseline/exposure 1 and exposure 3.|Statistical analysis of self-efficacy to manage HIV scale score between baseline/exposure 1 and exposure 3 to the intervention.||1.4|-0.2|0.1550
72360636|NCT00083889|144232515|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.038||||0.037||95.0|0.002|0.073|||Mixed Models Analysis|||Cycle 8 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)||0.073|0.002|0.0370
72360637|NCT00083889|144232515|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.037||||0.0464||95.0|0.001|0.074|||Mixed Models Analysis|||Cycle 9 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)||0.074|0.001|0.0464
72360638|NCT00083889|144232515|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.036||||0.0667||95.0|-0.002|0.075|||Mixed Models Analysis|||Cycle 9 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)||0.075|-0.002|0.0667
72360639|NCT00083889|144232515|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.036||||0.08||95.0|-0.004|0.076|||Mixed Models Analysis|||Cycle 10 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)||0.076|-0.004|0.0800
72360640|NCT00083889|144232515|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.035||||0.107||95.0|-0.007|0.077|||Mixed Models Analysis|||Cycle 10 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)||0.077|-0.007|0.1070
72360641|NCT00083889|144232515|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.034||||0.1237||95.0|-0.009|0.078|||Mixed Models Analysis|||Cycle 11 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)||0.078|-0.009|0.1237
72360642|NCT00083889|144232515|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.033||||0.1561||95.0|-0.013|0.079|||Mixed Models Analysis|||Cycle 11 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)||0.079|-0.013|0.1561
72360643|NCT00083889|144232515|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.033||||0.1752||95.0|-0.015|0.08|||Mixed Models Analysis|||Cycle 12 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)||0.080|-0.015|0.1752
72360644|NCT00083889|144232515|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.032||||0.2112||95.0|-0.018|0.081|||Mixed Models Analysis|||Cycle 12 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)||0.081|-0.018|0.2112
72360645|NCT00083889|144232515|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.031||||0.2319||95.0|-0.02|0.082|||Mixed Models Analysis|||Cycle 13 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)||0.082|-0.020|0.2319
72360646|NCT00083889|144232515|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.03||||0.2698||95.0|-0.023|0.084|||Mixed Models Analysis|||Cycle 13 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)||0.084|-0.023|0.2698
72360647|NCT00083889|144232515|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.03||||0.291||95.0|-0.025|0.085|||Mixed Models Analysis|||Cycle 14 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)||0.085|-0.025|0.2910
72360648|NCT00083889|144232515|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.029||||0.3293||95.0|-0.029|0.086|||Mixed Models Analysis|||Cycle 14 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)||0.086|-0.029|0.3293
72360649|NCT00083889|144232515|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.028||||0.3504||95.0|-0.031|0.087|||Mixed Models Analysis|||Cycle 15 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)||0.087|-0.031|0.3504
72360650|NCT00083889|144232515|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.027||||0.3881||95.0|-0.034|0.089|||Mixed Models Analysis|||Cycle 15 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)||0.089|-0.034|0.3881
72360651|NCT00083889|144232515|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.027||||0.4086||95.0|-0.036|0.09|||Mixed Models Analysis|||Cycle 16 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)||0.090|-0.036|0.4086
72360652|NCT00083889|144232515|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.026||||0.4449||95.0|-0.04|0.091|||Mixed Models Analysis|||Cycle 16 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)||0.091|-0.040|0.4449
72360653|NCT00083889|144232515|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.025||||0.4646||95.0|-0.042|0.092|||Mixed Models Analysis|||Cycle 17 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)||0.092|-0.042|0.4646
72360654|NCT00083889|144232515|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.024||||0.499||95.0|-0.046|0.094|||Mixed Models Analysis|||Cycle 17 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)||0.094|-0.046|0.4990
72360655|NCT00083889|144232515|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.024||||0.5176||95.0|-0.048|0.095|||Mixed Models Analysis|||Cycle 18 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)||0.095|-0.048|0.5176
72360656|NCT00083889|144232515|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.023||||0.5501||95.0|-0.051|0.097|||Mixed Models Analysis|||Cycle 18 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)||0.097|-0.051|0.5501
72360657|NCT00083889|144232515|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.022||||0.5675||95.0|-0.054|0.098|||Mixed Models Analysis|||Cycle 19 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)||0.098|-0.054|0.5675
72360658|NCT00083889|144232515|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.021||||0.5979||95.0|-0.057|0.099|||Mixed Models Analysis|||Cycle 19 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)||0.099|-0.057|0.5979
72360659|NCT00083889|144232515|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.021||||0.6141||95.0|-0.059|0.1|||Mixed Models Analysis|||Cycle 20 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)||0.100|-0.059|0.6141
72360660|NCT00083889|144232515|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.02||||0.6424||95.0|-0.063|0.102|||Mixed Models Analysis|||Cycle 20 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)||0.102|-0.063|0.6424
72360661|NCT00083889|144232516|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.026|||<|0.0001|TWO_SIDED|95.0|2.088|5.965|||Mixed Models Analysis|||Cycle 1 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline Euro-QoL Visual Analog Scale (EQ-VAS) baseline score (intercept and time since randomization are included as random effects).||5.965|2.088|<.0001
72360662|NCT00083889|144232516|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.165|||<|0.0001||95.0|2.269|6.061|||Mixed Models Analysis|||Cycle 1 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)||6.061|2.269|<.0001
72360663|NCT00083889|144232516|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.243|||<|0.0001||95.0|2.358|6.128|||Mixed Models Analysis|||Cycle 2 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)||6.128|2.358|<.0001
72360664|NCT00083889|144232516|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.382|||<|0.0001||95.0|2.494|6.269|||Mixed Models Analysis|||Cycle 2 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)||6.269|2.494|<.0001
72429372|NCT04102540|144369725|OTHER|In this model, the null hypothesis was that the odds of being non-adherent at baseline/exposure 1 were exactly equal to the odds of being non-adherent at exposure 2 giving an odds ratio of one for the null hypothesis.|Odds Ratio (OR)|1.17||||0.819|TWO_SIDED|95.0|0.3|4.52||The p-value was not adjusted for multiple comparisons and the a priori threshold for significance was alpha = 0.05.|Regression, Logistic|This model included random effects for subjects.|In this model, the odds ratio estimate is for the odds of being non-adherent at exposure 2 relative to the odds of being non-adherent at baseline/exposure 1.|"For analysis, we dichotomized participants adherence as adherent or non-adherent."||4.52|0.30|0.8190
72360665|NCT00083889|144232516|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.459|||<|0.0001||95.0|2.558|6.361|||Mixed Models Analysis|||Cycle 3 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)||6.361|2.558|<.0001
72360666|NCT00083889|144232516|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.598|||<|0.0001||95.0|2.65|6.547|||Mixed Models Analysis|||Cycle 3 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)||6.547|2.650|<.0001
72360667|NCT00083889|144232516|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.676|||<|0.0001||95.0|2.689|6.662|||Mixed Models Analysis|||Cycle 4 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)||6.662|2.689|<.0001
72360668|NCT00083889|144232516|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.815|||<|0.0001||95.0|2.741|6.889|||Mixed Models Analysis|||Cycle 4 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)||6.889|2.741|<.0001
72360669|NCT00083889|144232516|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.892|||<|0.0001||95.0|2.76|7.024|||Mixed Models Analysis|||Cycle 5 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)||7.024|2.760|<.0001
72360670|NCT00083889|144232516|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.031|||<|0.0001||95.0|2.78|7.283|||Mixed Models Analysis|||Cycle 5 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)||7.283|2.780|<.0001
72360671|NCT00083889|144232516|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.109|||<|0.0001||95.0|2.783|7.435|||Mixed Models Analysis|||Cycle 6 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)||7.435|2.783|<.0001
72360672|NCT00083889|144232516|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.248|||<|0.0001||95.0|2.776|7.72|||Mixed Models Analysis|||Cycle 6 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)||7.720|2.776|<.0001
72360673|NCT00083889|144232516|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.325|||<|0.0001||95.0|2.767|7.884|||Mixed Models Analysis|||Cycle 7 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)||7.884|2.767|<.0001
72360674|NCT00083889|144232516|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.464|||<|0.0001||95.0|2.741|8.188|||Mixed Models Analysis|||Cycle 7 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)||8.188|2.741|<.0001
72360675|NCT00083889|144232516|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.542||||0.0001||95.0|2.723|8.361|||Mixed Models Analysis|||Cycle 8 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)||8.361|2.723|0.0001
72360676|NCT00083889|144232516|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.681||||0.0002||95.0|2.683|8.679|||Mixed Models Analysis|||Cycle 8 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)||8.679|2.683|0.0002
72360677|NCT00083889|144232516|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.758||||0.0003||95.0|2.657|8.859|||Mixed Models Analysis|||Cycle 9 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)||8.859|2.657|0.0003
72360678|NCT00083889|144232516|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.898||||0.0004||95.0|2.607|9.188|||Mixed Models Analysis|||Cycle 9 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)||9.188|2.607|0.0004
72360679|NCT00083889|144232516|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.975||||0.0006||95.0|2.576|9.374|||Mixed Models Analysis|||Cycle 10 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)||9.374|2.576|0.0006
72360680|NCT00083889|144232516|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.114||||0.0009||95.0|2.517|9.711|||Mixed Models Analysis|||Cycle 10 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)||9.711|2.517|0.0009
72360681|NCT00083889|144232516|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.191||||0.0011||95.0|2.482|9.9|||Mixed Models Analysis|||Cycle 11 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)||9.900|2.482|0.0011
72360682|NCT00083889|144232516|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.331||||0.0015||95.0|2.417|10.244|||Mixed Models Analysis|||Cycle 11 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)||10.244|2.417|0.0015
72360683|NCT00083889|144232516|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.408||||0.0018||95.0|2.379|10.436|||Mixed Models Analysis|||Cycle 12 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)||10.436|2.379|0.0018
72360684|NCT00083889|144232516|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.547||||0.0025||95.0|2.309|10.785|||Mixed Models Analysis|||Cycle 12 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)||10.785|2.309|0.0025
72360685|NCT00083889|144232516|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.624||||0.0029||95.0|2.269|10.98|||Mixed Models Analysis|||Cycle 13 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)||10.980|2.269|0.0029
72360686|NCT00083889|144232516|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.764||||0.0037||95.0|2.195|11.332|||Mixed Models Analysis|||Cycle 13 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)||11.332|2.195|0.0037
72360687|NCT00083889|144232516|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.841||||0.0042||95.0|2.153|11.529|||Mixed Models Analysis|||Cycle 14 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)||11.529|2.153|0.0042
72360688|NCT00083889|144232516|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.98||||0.0053||95.0|2.076|11.884|||Mixed Models Analysis|||Cycle 14 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)||11.884|2.076|0.0053
72360689|NCT00083889|144232516|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.057||||0.0059||95.0|2.032|12.083|||Mixed Models Analysis|||Cycle 15 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)||12.083|2.032|0.0059
72360690|NCT00083889|144232516|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.197||||0.0072||95.0|1.953|12.441|||Mixed Models Analysis|||Cycle 15 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)||12.441|1.953|0.0072
72360691|NCT00083889|144232516|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.274||||0.0079||95.0|1.908|12.64|||Mixed Models Analysis|||Cycle 16 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)||12.640|1.908|0.0079
72360692|NCT00083889|144232516|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.413||||0.0093||95.0|1.826|13.0|||Mixed Models Analysis|||Cycle 16 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)||13.000|1.826|0.0093
72360693|NCT00083889|144232516|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.491||||0.0101||95.0|1.78|13.201|||Mixed Models Analysis|||Cycle 17 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)||13.201|1.780|0.0101
72360694|NCT00083889|144232516|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.63||||0.0117||95.0|1.697|13.562|||Mixed Models Analysis|||Cycle 17 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)||13.562|1.697|0.0117
72360695|NCT00083889|144232516|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.707||||0.0126||95.0|1.65|13.764|||Mixed Models Analysis|||Cycle 18 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)||13.764|1.650|0.0126
72360696|NCT00083889|144232516|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.846||||0.0144||95.0|1.565|14.127|||Mixed Models Analysis|||Cycle 18 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)||14.127|1.565|0.0144
72360697|NCT00083889|144232516|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.924||||0.0153||95.0|1.518|14.329|||Mixed Models Analysis|||Cycle 19 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)||14.329|1.518|0.0153
72360698|NCT00083889|144232516|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.063||||0.0172||95.0|1.432|14.693|||Mixed Models Analysis|||Cycle 19 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)||14.693|1.432|0.0172
72360699|NCT00083889|144232516|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.14||||0.0182||95.0|1.384|14.896|||Mixed Models Analysis|||Cycle 20 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)||14.896|1.384|0.0182
72360700|NCT00083889|144232516|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.279||||0.0201||95.0|1.297|15.261|||Mixed Models Analysis|||Cycle 20 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)||15.261|1.297|0.0201
72360701|NCT00534365|144232584|NON_INFERIORITY_OR_EQUIVALENCE|We chose a non-inferiority margin of 12% based on previously published multicenter trial of mid-urethral slings. Assuming subjective cure rate for TVT of 82%, 127 individuals in each group will provide 80% to reject the null hypothesis that the true difference in cure rates between the two procedures is less than or equal to 2% using a two group large sample normal approximation test of proportions with a one sided 0.05 significance level.||||||0.43|||||||Regression, Logistic|||||||0.43
72360702|NCT00534365|144232587|SUPERIORITY_OR_OTHER|||||||0.64|||||||t-test, 2 sided|||||||0.64
72360703|NCT00534365|144232588|SUPERIORITY_OR_OTHER|||||||0.015|||||||t-test, 2 sided|||||||0.015
72360704|NCT02099864|144232598|OTHER||Odds Ratio (OR)|10.0||||0.055|TWO_SIDED|95.0|0.9|108.8|||Fisher Exact|Due to sample size, Fisher's exact test was used rather than simple logistic regression.||||108.8|0.9|0.055
72360705|NCT02099864|144232599|OTHER||Odds Ratio (OR)|0.7||||1|TWO_SIDED|95.0|0.1|5.3|||Fisher Exact|Due to sample size, Fisher's exact was used rather than regression.||||5.3|0.1|1.000
72360706|NCT02099864|144232600|OTHER||Odds Ratio (OR)|0.7||||1|TWO_SIDED|95.0|0.0|17.0|||Fisher Exact|||||17.0|0.0|1.000
72360707|NCT02099864|144232601|OTHER||Median Difference (Final Values)|23.2||||0.84|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||Difference is the median for responders minus the median for non-responders.|||||0.84
72429373|NCT04102540|144369725|OTHER|In this model, the null hypothesis was that the odds of being non-adherent at baseline/exposure 1 were exactly equal to the odds of being non-adherent at exposure 3 giving an odds ratio of one for the null hypothesis.|Odds Ratio (OR)|0.3||||0.1332|TWO_SIDED|95.0|0.07|1.43||The p-value was not adjusted for multiple comparisons and the a priori threshold for significance was alpha = 0.05.|Regression, Logistic|This model included random effects for subjects.|In this model, the odds ratio estimate is for the odds of being non-adherent at exposure 3 relative to the odds of being non-adherent at baseline/exposure 1.|"For analysis, we dichotomized participants adherence as adherent or non-adherent."||1.43|0.07|0.1332
72360708|NCT02099864|144232602|OTHER||Median Difference (Final Values)|-1.9||||0.14|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||Difference is the median for responders minus the median for non-responders.|||||0.14
72360709|NCT02099864|144232603|OTHER||Odds Ratio (OR)|2.7||||1|TWO_SIDED|95.0|0.1|60.2|||Fisher Exact|||||60.2|0.1|1.00
72360710|NCT02099864|144232605|OTHER||Median Difference (Final Values)|4.8||||0.01|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||Difference is the median for the responders minus the median for the non-responders.|||||0.01
72360711|NCT02099864|144232608|OTHER||Hazard Ratio (HR)|0.18|||<|0.001|TWO_SIDED|95.0|0.07|0.45|||Regression, Cox|||||0.45|0.07|<0.001
72360712|NCT02099864|144232609|OTHER||Hazard Ratio (HR)|0.22||||0.002|TWO_SIDED|95.0|0.08|0.56|||Regression, Cox|||||0.56|0.08|0.002
72360713|NCT02099864|144232610|OTHER||Hazard Ratio (HR)|0.23||||0.23|TWO_SIDED|95.0|0.02|0.59|||Regression, Cox|||||0.59|0.02|0.23
72360714|NCT02099864|144232611|OTHER||Hazard Ratio (HR)|0.18|||<|0.001|TWO_SIDED|95.0|0.07|0.45|||Regression, Cox|||||0.45|0.07|<0.001
72360715|NCT02099864|144232616|OTHER||Hazard Ratio (HR)|4.9|||<|0.001|TWO_SIDED|95.0|2.03|11.82|||Regression, Cox|||||11.82|2.03|<0.001
72360716|NCT03409796|144232626|OTHER|||||||0.385|||||||t-test, 1 sided|||Gluten 3 gram: Baseline versus Day 15. Change in Vh:Cd follows a normal distribution. A 1-sided paired t-test was used to compare Baseline and follow-up Vh:Cd measures. The normality assumption was checked using the Shapiro-Wilk test. If the data was not normal at alpha=0.05, a 1-sided Wilcoxon signed-rank test was used instead to compare Vh:CdBaseline (B) and Vh:Cd15.||||0.385
72360717|NCT03409796|144232626|OTHER|||||||0.003|||||||t-test, 1 sided|||Gluten 10 gram: Baseline versus Day 15. Change in Vh:Cd follows a normal distribution. A 1-sided paired t-test was used to compare Baseline and follow-up Vh:Cd measures. The normality assumption was checked using the Shapiro-Wilk test. If the data was not normal at alpha=0.05, a 1-sided Wilcoxon signed-rank test was used instead to compare Vh:CdB and Vh:Cd15.||||0.003
72360718|NCT03409796|144232627|OTHER|||||||0.01|||||||Poisson distribution|||Gluten 3 gram: Baseline versus Day 15. The Poisson distribution assumption was checked using Kolmogorov-Smirnov test. Poisson generalized linear mixed models (GLMM) was fitted to data, where IEL measurements were grouped by participant (the random effect) and the change in IEL counts was the fixed effect. If the data was found to not be Poisson at alpha=0.05, a 1-sided Wilcoxon signed-rank test was used instead to compare IELB and IEL15.||||0.010
72360719|NCT03409796|144232627|OTHER|||||||0.006|||||||Poisson distribution|||Gluten 10 gram: Baseline versus Day 15. The Poisson distribution assumption was checked using Kolmogorov-Smirnov test. Poisson GLMM was fitted to data, where IEL measurements were grouped by participant (the random effect) and the change in IEL counts was the fixed effect. If the data was found to not be Poisson at alpha=0.05, a 1-sided Wilcoxon signed-rank test was used instead to compare IELB and IEL15.||||0.006
72360720|NCT01602224|144232643|SUPERIORITY||Odds Ratio (OR)|1.98||||0.401|TWO_SIDED||||||Regression, Logistic|||100 mg Tabalumab+Dexamethasone+Bortezomib compared with Placebo Comparator: Placebo + Dexamethasone + Bortezombib, only tabalumab odds ratio compared to placebo.||||0.401
72360721|NCT01602224|144232643|SUPERIORITY||Odds Ratio (OR)|1.84||||0.455|TWO_SIDED||||||Regression, Logistic|||300 mg Tabalumab+Dexamethasone+Bortezomib compared with Placebo Comparator: Placebo + Dexamethasone + Bortezombib, only tabalumab odds ratio compared to placebo.||||0.455
72360722|NCT01602224|144232643|SUPERIORITY||Odds Ratio (OR)|1.9||||0.419|TWO_SIDED||||||Regression, Logistic|||100 mg Tabalumab+Dexamethasone+Bortezomib and 300 mg Tabalumab+Dexamethasone+Bortezomib compared with Placebo Comparator: Placebo + Dexamethasone + Bortezombib, only compared to placebo.||||0.419
72360723|NCT01352117|144232645|SUPERIORITY|||||||0.911||||||The critical value for the final analysis was adjusted for the three interim analyses conducted for the Data and Safety Monitoring Board (DSMB) review using the Haybittle-Peto guidelines, at the p-value cutoff of 0.0487.|Wilcoxon (Mann-Whitney)|Stratified Wilcoxon-Mann-Whitney test (asymptotic method) known as van Elteren test, stratification by screening CD4 (\<200 vs. \>=200 cells/mm\^3).||||||0.911
72360724|NCT00770653|144232684|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.267||||0.0018|TWO_SIDED|95.0|1.2264|5.3076|||ANCOVA|||Null hypothesis (H0) = mean increase of HDL after 24 weeks of treatment of Pio/Met group ≤ the mean increase in the Gli/Met group. Alternate hypothesis (H1) = mean increase of HDL after 24 weeks of treatment of Pio/Met group \> the mean increase in the Gli/Met group. The relevant clinical effect size to detect with adequate power was 0.35. With this assumption, a one sided t-test with a type I error rate had 80% power to reject the H0 for the H1 when the sample size was 130 patients per group.||5.3076|1.2264|0.0018
72360725|NCT00770653|144232685|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.267||||0.0018|TWO_SIDED|95.0|1.2264|5.3076|||ANCOVA||Deviation from the normal distribution assumption was detected for original and rank-transformed data for all time-points due to p-value of Shapiro-Wilk test, indicating the normal distribution assumption might be distrusted for HDL-cholesterol data.|||5.3076|1.2264|0.0018
72360726|NCT00770653|144232686|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1311||||0.1167|TWO_SIDED|95.0|-0.2951|0.0329|||ANCOVA|||||0.0329|-0.2951|0.1167
72360727|NCT00770653|144232687|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.9479||||0.1012|TWO_SIDED|95.0|-39.4331|3.5373|||ANCOVA|||||3.5373|-39.4331|0.1012
72360728|NCT00770653|144232688|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.1292||||0.7486|TWO_SIDED|95.0|-17.0109|23.2693|||ANCOVA|||||23.2693|-17.0109|0.7486
72360729|NCT00770653|144232689|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2355||||0.9464|TWO_SIDED|95.0|-7.1253|6.6543|||ANCOVA|||||6.6543|-7.1253|0.9464
72360730|NCT00770653|144232690|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1574||||0.0807|TWO_SIDED|95.0|-0.0193|0.3341|||ANCOVA|||||0.3341|-0.0193|0.0807
72360731|NCT00770653|144232691|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.5039|||<|0.0001|TWO_SIDED|95.0|-6.4222|-2.5855|||ANCOVA|||||-2.5855|-6.4222|<.0001
72360732|NCT00770653|144232692|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.0707||||0.7799|TWO_SIDED|95.0|-6.4665|8.6079|||ANCOVA|||||8.6079|-6.4665|0.7799
72360733|NCT00770653|144232693|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.3161|||<|0.0001|TWO_SIDED|95.0|5.0994|7.5329|||ANCOVA|||||7.5329|5.0994|<.0001
72360734|NCT00770653|144232694|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8323||||0.4131|TWO_SIDED|95.0|-2.8312|1.1665|||ANCOVA|||||1.1665|-2.8312|0.4131
72360735|NCT00770653|144232695|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8847|||<|0.0001|TWO_SIDED|95.0|-1.3067|-0.4627|||ANCOVA|||||-0.4627|-1.3067|<.0001
72360736|NCT00770653|144232696|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.4903||||0.0929|TWO_SIDED|95.0|-5.3979|0.4172|||ANCOVA|||||0.4172|-5.3979|0.0929
72360737|NCT00770653|144232697|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8832||||0.3279|TWO_SIDED|95.0|-2.6571|0.8906|||ANCOVA|||||0.8906|-2.6571|0.3279
72360738|NCT00770653|144232698|SUPERIORITY_OR_OTHER||Fisher Exact|-3.33||||0.2895|TWO_SIDED|95.0|-14.83|8.39|||Fisher Exact|||The number and percentage of participants with a calculated compliance \>80% and \<120% are presented for both treatment groups. In addition, the p-values of Fisher's exact test, the two-sided 95% confidence intervals for the percentage of patients per treatment group and for the difference between the treatment groups are provided.||8.39|-14.83|0.2895
72360739|NCT00770653|144232699|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-29.9516||||0.3517|TWO_SIDED|95.0|-94.1999|34.2967|||ANCOVA|||||34.2967|-94.1999|0.3517
72360740|NCT00770653|144232700|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-151.4477||||0.1979|TWO_SIDED|95.0|-386.2256|83.3302|||ANCOVA|||||83.3302|-386.2256|0.1979
72360741|NCT00770653|144232701|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-24.8589||||0.7186|TWO_SIDED|95.0|-163.3229|113.6052|||ANCOVA|||||113.6052|-163.3229|0.7186
72360742|NCT00770653|144232702|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.9728||||0.5058|TWO_SIDED|95.0|-39.9915|20.0459|||ANCOVA|||||20.0459|-39.9915|0.5058
72360743|NCT00770653|144232703|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|28.3988||||0.523|TWO_SIDED|95.0|-60.7193|117.5169|||ANCOVA|||||117.5169|-60.7193|0.5230
72360744|NCT00770653|144232704|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-367.2639||||0.2203|TWO_SIDED|95.0|-964.3923|229.8646|||ANCOVA|||||229.8646|-964.3923|0.2203
72360745|NCT00770653|144232705|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|28.0794||||0.585|TWO_SIDED|95.0|-95.6468|151.8057|||ANCOVA|||||151.8057|-95.6468|0.5850
72360746|NCT00770653|144232706|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.4205||||0.0138|TWO_SIDED|95.0|-4.3207|-0.5202|||ANCOVA|||||-0.5202|-4.3207|0.0138
72360747|NCT00770653|144232707|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0009||||0.0817|TWO_SIDED|95.0|-30.1139|1.8578|||ANCOVA|||||1.8578|-30.1139|0.0817
72360748|NCT00770653|144232708|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.9935||||0.1761|TWO_SIDED|95.0|-0.4843|2.4712|||ANCOVA|||||2.4712|-0.4843|0.1761
72360749|NCT00770653|144232709|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.5263||||0.0002|TWO_SIDED|95.0|1.3832|3.6695|||ANCOVA|||||3.6695|1.3832|0.0002
72360750|NCT00770653|144232710|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.2345||||0.0055|TWO_SIDED|95.0|1.0675|5.4016|||ANCOVA|||||5.4016|1.0675|0.0055
72360751|NCT00770653|144232711|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.9712||||0.0264|TWO_SIDED|95.0|0.3863|5.5562|||ANCOVA|||||5.5562|0.3863|0.0264
72360752|NCT00770653|144232712|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.5394||||0.0509|TWO_SIDED|95.0|-0.0114|5.0901|||ANCOVA|||||5.0901|-0.0114|0.0509
72360753|NCT00770653|144232713|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.1718||||0.1013|TWO_SIDED|95.0|-0.466|4.8097|||ANCOVA|||||4.8097|-0.4660|0.1013
72360754|NCT00770653|144232714|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.1346||||0.1363|TWO_SIDED|95.0|-0.7338|5.0031|||ANCOVA|||||5.0031|-0.7338|0.1363
72360755|NCT00770653|144232715|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.4181||||0.1165|TWO_SIDED|95.0|-0.6561|5.4922|||ANCOVA|||||5.4922|-0.6561|0.1165
72360756|NCT04906499|144232723|OTHER||Cohen's d effect size|0.13|||||TWO_SIDED|95.0|-0.68|0.93||||||||0.93|-0.68|
72360757|NCT04906499|144232725|OTHER||Cohen's d effect size|0.42|||||TWO_SIDED|95.0|-0.44|1.24||||||||1.24|-0.44|
72360758|NCT04906499|144232727|OTHER||Cohen's d effect size|0.85|||||TWO_SIDED|95.0|-0.13|1.77||||||||1.77|-0.13|
72360759|NCT04906499|144232729|OTHER||Cohen's d effect size|0.97|||||TWO_SIDED|95.0|-0.05|1.93||||||||1.93|-0.05|
72360760|NCT04906499|144232731|OTHER||Pearson's r Correlation Coefficient|0.32|||||TWO_SIDED|95.0|-0.67|0.9||||||||0.90|-0.67|
72360761|NCT04906499|144232732|OTHER||Pearson's r Correlation Coefficient|0.55|||||TWO_SIDED|95.0|-0.48|0.94||||||||0.94|-0.48|
72360762|NCT04906499|144232733|OTHER||Pearson's r Correlation Coefficient|0.23|||||TWO_SIDED|95.0|-0.88|0.71||||||||0.71|-0.88|
72360763|NCT04906499|144232734|OTHER||Pearson's r Correlation Coefficient|-0.19|||||TWO_SIDED|95.0|-0.87|0.73||||||||0.73|-0.87|
72360764|NCT04906499|144232736|OTHER||Cohen's d effect size|-0.42|||||TWO_SIDED|95.0|-1.24|0.44||||||||0.44|-1.24|
72360765|NCT00179621|144232739|SUPERIORITY_OR_OTHER||||||<|0.001||||||To compare the response rates of Lenalidomide 5 mg QD vs. placebo, the Hochberg procedure was used to control the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Stratified by International Prognostic Scoring System (IPSS) score (IPSS combined score =0 versus \>0) to compare lenalidomide treatment with placebo.||||||<0.001
72360766|NCT00179621|144232739|SUPERIORITY_OR_OTHER||||||<|0.001||||||To compare the response rates of Lenalidomide 10 mg QD vs. placebo, the Hochberg procedure was used to control the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Stratified by International Prognostic Scoring System (IPSS) score (IPSS combined score =0 versus \>0) to compare lenalidomide treatment with placebo.||||||<0.001
72360767|NCT00179621|144232740|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|Stratified by International Prognostic Scoring System (IPSS) score (IPSS combined score =0 versus \>0) to compare lenalidomide treatment with placebo.||||||<0.001
72360768|NCT00179621|144232740|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|Stratified by International Prognostic Scoring System (IPSS) score (IPSS combined score =0 versus \>0) to compare lenalidomide treatment with placebo.||||||<0.001
72360769|NCT00179621|144232750|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||ANOVA|||||||<0.05
72360770|NCT00179621|144232750|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||ANOVA|||||||<0.05
72360771|NCT00179621|144232751|SUPERIORITY_OR_OTHER|||||||0.054||95.0|||||ANOVA|||||||0.054
72360772|NCT00179621|144232751|SUPERIORITY_OR_OTHER|||||||0.08||95.0|||||ANOVA|||||||0.080
72360773|NCT00179621|144232752|SUPERIORITY_OR_OTHER|||||||0.062||95.0|||||ANOVA|||||||0.062
72360774|NCT00179621|144232752|SUPERIORITY_OR_OTHER|||||||0.113||95.0|||||ANOVA|||||||0.113
72360775|NCT02722564|144232755|OTHER||||||<|0.001||||||p value associated with the change between estimated and actual BrAC when the participants BrAC was ascending to 0.1.|t-test, 2 sided|||||||<0.001
72360776|NCT02722564|144232755|OTHER||||||<|0.0001||||||p value associated with change between estimated and actual BrAC as participants BrAC descended to 0.08.|t-test, 2 sided|||||||<0.0001
72360777|NCT01751061|144232775|SUPERIORITY|To test the primary hypothesis, we used a general linear model fit with generalized estimating equations, a linear link, and an exchangeable correlation (PROC GENMOD). Model parameters included indictor variables for intervention, Interview 2, the interaction between intervention and Interview 2, and a 4-level site variable. The mean CSCS between-groups difference, corresponding 95% confidence interval (CI), and p value were derived from the intervention-by-Interview 2 interaction term.|||||<|0.05||||||P values were calculated. A two-sided type-I error rate of 0.05 was set for all tests; there were no adjustments for multiple comparisons. All participants were included in analyses as per their group randomization.|GEE|||We estimated that 210 patients (315 surrogates, assuming \~1.5 per patient) would provide a power of 80% to detect a between-groups mean CSCS score difference of 9 percentage points between Interviews 1 and 2, assuming a baseline mean of 50, SD=24, a type-I error=5%, a correlation between interviews of 0.5, an expectation that 50% of patients would have multiple surrogates, an intraclass correlation coefficient of 0.8 for multiple surrogates for a patient, and 5% dropout before Interview 2.||||<0.05
72360778|NCT01751061|144232776|SUPERIORITY||||||<|0.05||||||P values were calculated.|generalized linear model|||Generalized linear model.||||<0.05
72360779|NCT01751061|144232777|SUPERIORITY||||||<|0.05||||||P values were calculated.|generalized linear model|||||||<0.05
72360780|NCT01751061|144232778|SUPERIORITY||||||<|0.05||||||P values were calculated.|generalized linear models|||||||<0.05
72360781|NCT01751061|144232779|SUPERIORITY||||||<|0.05||||||P values were calculated.|generalized linear models|||||||<0.05
72360782|NCT01751061|144232780|SUPERIORITY||||||<|0.05||||||P values were calculated.|generalized linear models|||||||<0.05
72360783|NCT01751061|144232781|SUPERIORITY||||||<|0.05||||||P values were calculated.|GEE|||To test the hypothesis, we used a general linear model fit with generalized estimating equations, a linear link, and an exchangeable correlation (PROC GENMOD). Model parameters included indictor variables for intervention, Interview 2, the interaction between intervention and Interview 2, and a 4-level site variable. The mean CSCS between-groups difference, corresponding 95% confidence interval (CI), and p value were derived from the intervention-by-Interview 2 interaction term.||||<0.05
72360784|NCT01194830|144232784|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.58|STANDARD_ERROR_OF_MEAN|0.16||0.0005||95.0|-0.91|-0.26|||ANCOVA|ANCOVA model included terms for treatment, baseline HbA1c and number of other Oral Antidiabetic Drugs||||-0.26|-0.91|0.0005
72360785|NCT01194830|144232785|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.42|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001||95.0|-0.62|-0.22|||ANCOVA|ANCOVA model included terms for treatment, baseline HbA1c and number of other Oral Antidiabetic Drugs||||-0.22|-0.62|<0.0001
72360786|NCT01194830|144232786|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.55|STANDARD_ERROR_OF_MEAN|0.15||0.0002||95.0|-0.84|-0.26|||ANCOVA|ANCOVA model included terms for treatment, baseline HbA1c and number of other Oral Antidiabetic Drugs||||-0.26|-0.84|0.0002
72360787|NCT01194830|144232787|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.55|STANDARD_ERROR_OF_MEAN|0.15||0.0003||95.0|-0.85|-0.26|||ANCOVA|ANCOVA model included terms for treatment, baseline HbA1c and number of other Oral Antidiabetic Drugs||||-0.26|-0.85|0.0003
72360788|NCT01194830|144232788|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.063||||0.001|TWO_SIDED|95.0|1.764|9.358|||Regression, Logistic|||||9.358|1.764|0.0010
72360789|NCT01194830|144232789|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.433||||0.0352|TWO_SIDED|95.0|1.124|26.26|||Regression, Logistic|||||26.260|1.124|0.0352
72360790|NCT01194830|144232790|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.951||||0.0003|TWO_SIDED|95.0|1.651|5.274|||Regression, Logistic|||||5.274|1.651|0.0003
72360791|NCT01194830|144232791|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-12.0|STANDARD_ERROR_OF_MEAN|7.2||0.0972||95.0|-26.1|2.2|||ANCOVA|ANCOVA model included terms for treatment, baseline HbA1c, baseline FPG, and number of other Oral Antidiabetic Drugs||||2.2|-26.1|0.0972
72360792|NCT01194830|144232792|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-1.97|STANDARD_ERROR_OF_MEAN|24.45||0.9368||95.0|-53.8|49.86|||ANCOVA|ANCOVA model included terms for treatment, baseline HbA1c, baseline 2-hour PPG, and number of other Oral Antidiabetic Drugs||||49.86|-53.80|0.9368
72360793|NCT03284710|144232815|OTHER|||||||0.358||||||The threshold for statistical significance was p = 0.05.|Barnard's test|||IgGAb binding to 1086C\_D7gp120.avi/293F in Group 1 versus Group 2||||0.358
72360794|NCT03284710|144232815|OTHER|||||||1||||||The threshold for statistical significance was p = 0.05.|Barnard's test|||IgGAb binding to 96ZM651.D11gp120.avi in Group 1 versus Group 2||||1.000
72360795|NCT03284710|144232815|OTHER|||||||0.361||||||The threshold for statistical significance was p = 0.05.|Barnard's test|||IgGAb binding to TV1c8\_D11gp120.avi/293F in Group 1 versus Group 2||||0.361
72360796|NCT03284710|144232816|OTHER|||||||0.238||||||The threshold for statistical significance was p = 0.05.|Wilcoxon (Mann-Whitney)|||IgGAb binding to 1086C\_D7gp120.avi/293F in Group 1 versus Group 2||||0.238
72360797|NCT03284710|144232816|OTHER|||||||0.893||||||The threshold for statistical significance was p = 0.05.|Wilcoxon (Mann-Whitney)|||IgGAb binding to 96ZM651.D11gp120.avi in Group 1 versus Group 2||||0.893
72360798|NCT03284710|144232816|OTHER|||||||0.411||||||The threshold for statistical significance was p = 0.05.|Wilcoxon (Mann-Whitney)|||IgGAb binding to TV1c8\_D11gp120.avi/293F in Group 1 versus Group 2||||0.411
72360799|NCT03284710|144232817|OTHER|||||||1||||||The threshold for statistical significance was p = 0.05.|Barnard's test|||IgAAb binding to 1086C\_D7gp120.avi/293F in Group 1 versus Group 3||||1.000
72360800|NCT03284710|144232817|OTHER|||||||0.044||||||The threshold for statistical significance was p = 0.05.|Barnard's test|||IgAAb binding to 96ZM651.D11gp120.avi in Group 1 versus Group 3||||0.044
72360801|NCT03284710|144232817|OTHER|||||||0.045||||||The threshold for statistical significance was p = 0.05.|Barnard's test|||IgAAb binding to TV1c8\_D11gp120.avi/293F in Group 1 versus Group 3||||0.045
72360802|NCT03284710|144232818|OTHER|||||||0.215||||||The threshold for statistical significance was p = 0.05.|Wilcoxon (Mann-Whitney)|||IgAAb binding to 1086C\_D7gp120.avi/293F in Group 1 versus Group 3||||0.215
72360803|NCT03284710|144232818|OTHER|||||||0.683||||||The threshold for statistical significance was p = 0.05.|Wilcoxon (Mann-Whitney)|||IgAAb binding to 96ZM651.D11gp120.avi in Group 1 versus Group 3||||0.683
72360804|NCT03284710|144232818|OTHER|||||||0.322||||||The threshold for statistical significance was p = 0.05.|Wilcoxon (Mann-Whitney)|||IgAAb binding to TV1c8\_D11gp120.avi/293F in Group 1 versus Group 3||||0.322
72360805|NCT00910104|144232899|SUPERIORITY||Hazard Ratio (HR)|8.6|||=|0.001|TWO_SIDED|95.0|2.0|37.3||All P-values were 2-sided. Analyses were performed in SAS 9.1 (SAS Institute, USA) and S-plus 8 (Insightful, USA). P\<0.05 was established as an a priori threshold for statistical significance.|Regression, Cox|||The primary efficacy end-point was time to reversal of cholestasis (direct bilirubin \[DB\]\<=2 mg/dL). Crude (unadjusted) hazard ratios were estimated using proportional hazard regression. Subjects who died, were transplanted, or still on PN at the end of follow-up were censored (Ref: PMID 19661785).||37.3|2.0|=0.001
72360806|NCT00910104|144232899|SUPERIORITY||Hazard Ratio (HR)|17.4||||0.001|TWO_SIDED|95.0|3.7|83.0||All P-values were 2-sided. Analyses were performed in SAS 9.1 (SAS Institute, USA) and S-plus 8 (Insightful, USA). P\<0.05 was established as an a priori threshold for statistical significance.|Regression, Cox|||The primary efficacy end-point was time to reversal of cholestasis (direct bilirubin \[DB\]\<=2 mg/dL). Adjusted hazard ratios were estimated using proportional hazard regression adjusted for baseline covariates (including duration of parenteral nutrition (PN) and baseline DB). Subjects who died, were transplanted, or still on PN at the end of follow-up were censored (Ref: PMID 19661785).||83|3.7|0.001
72360807|NCT00910104|144232899|OTHER||||||<|0.0001|||||||Fisher Exact|||Comparison of proportion with reversal of cholestasis (direct bilirubin \<=2.0 mg/dL).||||<0.0001
72360808|NCT01706458|144232908|OTHER|||||||0.906|||||||Log Rank|||||||0.9060
72360809|NCT03547518|144232920|SUPERIORITY|||||||0.111|||||||t-test, 2 sided|||||||0.111
72360810|NCT03547518|144232921|SUPERIORITY|||||||0.487|||||||t-test, 2 sided|||||||0.487
72360811|NCT03547518|144232922|SUPERIORITY|||||||0.0393|||||||t-test, 2 sided|||||||0.0393
72360812|NCT03547518|144232923|SUPERIORITY|||||||0.242|||||||t-test, 2 sided|||||||0.242
72360813|NCT03547518|144232924|SUPERIORITY|||||||0.855|||||||t-test, 2 sided|||||||0.855
72360814|NCT04742556|144232925|OTHER||Probability of true DLT rate in [0.33-1]|0.0051||||||||||||||Probability of true DLT rate was determined using a Bayesian 2-parameter logistic regression model with overdose control.||||
72360815|NCT04742556|144232925|OTHER||Probability of true DLT rate in [0.33-1]|0.03105||||||||||||||Probability of true DLT rate was determined using a Bayesian 2-parameter logistic regression model with overdose control.||||
72360816|NCT04742556|144232925|OTHER||Probability of true DLT rate in [0.33-1]|0.27405||||||||||||||Probability of true DLT rate was determined using a Bayesian 2-parameter logistic regression model with overdose control.||||
72360817|NCT02201524|144232936|SUPERIORITY_OR_OTHER||Least square (LS) mean difference|-5.08|STANDARD_ERROR_OF_MEAN|2.42|||TWO_SIDED|90.0|-9.15|-1.01||||||PF-04965842 200 mg vs Placebo: Longitudinal analysis of covariance (LANCOVA) model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.||-1.01|-9.15|
72360818|NCT02201524|144232936|SUPERIORITY_OR_OTHER||LS mean difference|-5.61|STANDARD_ERROR_OF_MEAN|2.375|||TWO_SIDED|90.0|-9.61|-1.62||||||PF-04965842 400 mg vs Placebo: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.||-1.62|-9.61|
72360819|NCT02201524|144232936|SUPERIORITY_OR_OTHER||LS mean difference|-9.98|STANDARD_ERROR_OF_MEAN|2.506|||TWO_SIDED|90.0|-14.19|-5.77||||||PF-04965842 200 mg vs Placebo: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.||-5.77|-14.19|
72360820|NCT02201524|144232937|SUPERIORITY_OR_OTHER||LS mean difference|-9.32|STANDARD_ERROR_OF_MEAN|8.291|||TWO_SIDED|90.0|-23.19|4.56||||||PF-04965842 200 mg vs Placebo at Week 1: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.||4.56|-23.19|
72360821|NCT02201524|144232937|SUPERIORITY_OR_OTHER||LS mean difference|-11.19|STANDARD_ERROR_OF_MEAN|8.177|||TWO_SIDED|90.0|-24.87|2.5||||||PF-04965842 400 mg vs Placebo at Week 1: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.||2.50|-24.87|
72360822|NCT02201524|144232937|SUPERIORITY_OR_OTHER||LS mean difference|-19.22|STANDARD_ERROR_OF_MEAN|8.504|||TWO_SIDED|90.0|-33.45|-4.99||||||PF-04965842 200 mg vs Placebo at Week 1: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.||-4.99|-33.45|
72360823|NCT02201524|144232937|SUPERIORITY_OR_OTHER||LS mean difference|-4.3|STANDARD_ERROR_OF_MEAN|10.387|||TWO_SIDED|90.0|-21.71|13.11||||||PF-04965842 200 mg vs Placebo at Week 2: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.||13.11|-21.71|
72360824|NCT02201524|144232937|SUPERIORITY_OR_OTHER||LS mean difference|-18.04|STANDARD_ERROR_OF_MEAN|10.273|||TWO_SIDED|90.0|-35.25|-0.82||||||PF-04965842 400 mg vs Placebo at Week 2: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.||-0.82|-35.25|
72360825|NCT02201524|144232937|SUPERIORITY_OR_OTHER||LS mean difference|-27.07|STANDARD_ERROR_OF_MEAN|10.646|||TWO_SIDED|90.0|-44.9|-9.23||||||PF-04965842 200 mg vs Placebo at Week 2: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.||-9.23|-44.90|
72360826|NCT02201524|144232937|SUPERIORITY_OR_OTHER||LS mean difference|-10.07|STANDARD_ERROR_OF_MEAN|11.013|||TWO_SIDED|90.0|-28.53|8.39||||||PF-04965842 200 mg vs Placebo at Week 3: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.||8.39|-28.53|
72360827|NCT02201524|144232937|SUPERIORITY_OR_OTHER||LS mean difference|-29.23|STANDARD_ERROR_OF_MEAN|10.793|||TWO_SIDED|90.0|-47.33|-11.13||||||PF-04965842 400 mg vs Placebo at Week 3: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.||-11.13|-47.33|
72360828|NCT02201524|144232937|SUPERIORITY_OR_OTHER||LS mean difference|-49.99|STANDARD_ERROR_OF_MEAN|11.299|||TWO_SIDED|90.0|-68.92|-31.05||||||PF-04965842 200 mg vs Placebo at Week 3: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.||-31.05|-68.92|
72360829|NCT02201524|144232937|SUPERIORITY_OR_OTHER||LS mean difference|-24.25|STANDARD_ERROR_OF_MEAN|11.33|||TWO_SIDED|90.0|-43.26|-5.24||||||PF-04965842 200 mg vs Placebo at Week 4: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.||-5.24|-43.26|
72360830|NCT02201524|144232937|SUPERIORITY_OR_OTHER||LS mean difference|-27.47|STANDARD_ERROR_OF_MEAN|11.155|||TWO_SIDED|90.0|-46.18|-8.75||||||PF-04965842 400 mg vs Placebo at Week 4: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.||-8.75|-46.18|
72360831|NCT02201524|144232937|SUPERIORITY_OR_OTHER||LS mean difference|-52.63|STANDARD_ERROR_OF_MEAN|11.697|||TWO_SIDED|90.0|-72.24|-33.02||||||PF-04965842 200 mg vs Placebo at Week 4: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.||-33.02|-72.24|
72360832|NCT02201524|144232937|SUPERIORITY_OR_OTHER||LS mean difference|-17.98|STANDARD_ERROR_OF_MEAN|10.605|||TWO_SIDED|90.0|-35.8|-0.15|||LANCOVA|||PF-04965842 200 mg vs Placebo at Week 5: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.||-0.15|-35.80|
72360833|NCT02201524|144232937|SUPERIORITY_OR_OTHER||LS mean difference|-14.78|STANDARD_ERROR_OF_MEAN|10.513|||TWO_SIDED|90.0|-32.44|2.88||||||PF-04965842 400 mg vs Placebo at Week 5: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.||2.88|-32.44|
72360834|NCT02201524|144232937|SUPERIORITY_OR_OTHER||LS mean difference|-47.94|STANDARD_ERROR_OF_MEAN|11.125|||TWO_SIDED|90.0|-66.61|-29.27||||||PF-04965842 200 mg vs Placebo at Week 5: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.||-29.27|-66.61|
72360835|NCT02201524|144232937|SUPERIORITY_OR_OTHER||LS mean|-21.75|STANDARD_ERROR_OF_MEAN|11.459|||TWO_SIDED|90.0|-41.0|-2.49||||||PF-04965842 200 mg vs Placebo at Week 6: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.||-2.49|-41.00|
72360836|NCT02201524|144232937|SUPERIORITY_OR_OTHER||LS mean difference|-17.75|STANDARD_ERROR_OF_MEAN|11.416|||TWO_SIDED|90.0|-36.92|1.42||||||PF-04965842 400 mg vs Placebo at Week 6: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.||1.42|-36.92|
72360837|NCT02201524|144232937|SUPERIORITY_OR_OTHER||LS mean difference|-35.88|STANDARD_ERROR_OF_MEAN|11.893|||TWO_SIDED|90.0|-55.85|-15.9||||||PF-04965842 200 mg vs Placebo at Week 6: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.||-15.90|-55.85|
72360838|NCT02201524|144232937|SUPERIORITY_OR_OTHER||LS mean difference|-10.75|STANDARD_ERROR_OF_MEAN|12.985|||TWO_SIDED|90.0|-32.57|11.07||||||PF-04965842 200 mg vs Placebo at Week 8: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.||11.07|-32.57|
72360839|NCT02201524|144232937|SUPERIORITY_OR_OTHER||LS mean difference|-13.03|STANDARD_ERROR_OF_MEAN|12.902|||TWO_SIDED|90.0|-34.71|8.64||||||PF-04965842 400 mg vs Placebo at Week 8: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.||8.64|-34.71|
72360840|NCT02201524|144232937|SUPERIORITY_OR_OTHER||LS mean difference|-34.46|STANDARD_ERROR_OF_MEAN|13.69|||TWO_SIDED|90.0|-57.44|-11.48||||||PF-04965842 200 mg vs Placebo at Week 8: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.||-11.48|-57.44|
72360841|NCT02201524|144232938|SUPERIORITY_OR_OTHER||LS mean difference|-2.01|STANDARD_ERROR_OF_MEAN|1.626|||TWO_SIDED|90.0|-4.73|0.72||||||PF-04965842 200 mg vs Placebo at Week 1: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.||0.72|-4.73|
72360842|NCT02201524|144232938|SUPERIORITY_OR_OTHER||LS mean difference|-2.31|STANDARD_ERROR_OF_MEAN|1.603|||TWO_SIDED|90.0|-4.99|0.38||||||PF-04965842 400 mg vs Placebo at Week 1: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.||0.38|-4.99|
72360843|NCT02201524|144232938|SUPERIORITY_OR_OTHER||LS mean difference|-3.65|STANDARD_ERROR_OF_MEAN|1.668|||TWO_SIDED|90.0|-6.45|-0.86||||||PF-04965842 200 mg vs Placebo at Week 1: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.||-0.86|-6.45|
72360844|NCT02201524|144232938|SUPERIORITY_OR_OTHER||LS mean difference|-1.08|STANDARD_ERROR_OF_MEAN|2.032|||TWO_SIDED|90.0|-4.49|2.32||||||PF-04965842 200 mg vs Placebo at Week 2: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.||2.32|-4.49|
72360845|NCT02201524|144232938|SUPERIORITY_OR_OTHER||LS mean difference|-3.86|STANDARD_ERROR_OF_MEAN|2.011|||TWO_SIDED|90.0|-7.23|-0.49||||||PF-04965842 400 mg vs Placebo at Week 2: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.||-0.49|-7.23|
72360846|NCT02201524|144232938|SUPERIORITY_OR_OTHER||LS mean difference|-5.16|STANDARD_ERROR_OF_MEAN|2.084|||TWO_SIDED|90.0|-8.65|-1.67||||||PF-04965842 200 mg vs Placebo at Week 2: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.||-1.67|-8.65|
72360847|NCT02201524|144232938|SUPERIORITY_OR_OTHER||LS mean difference|-2.34|STANDARD_ERROR_OF_MEAN|2.224|||TWO_SIDED|90.0|-6.07|1.39||||||PF-04965842 200 mg vs Placebo at Week 3: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.||1.39|-6.07|
72360848|NCT02201524|144232938|SUPERIORITY_OR_OTHER||LS mean difference|-6.12|STANDARD_ERROR_OF_MEAN|2.177|||TWO_SIDED|90.0|-9.78|-2.47||||||PF-04965842 400 mg vs Placebo at Week 3: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.||-2.47|-9.78|
72360849|NCT02201524|144232938|SUPERIORITY_OR_OTHER||LS mean difference|-9.39|STANDARD_ERROR_OF_MEAN|2.286|||TWO_SIDED|90.0|-13.22|-5.56||||||PF-04965842 200 mg vs Placebo at Week 3: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.||-5.56|-13.22|
72360850|NCT02201524|144232938|SUPERIORITY_OR_OTHER||LS mean difference|-3.25|STANDARD_ERROR_OF_MEAN|2.054|||TWO_SIDED|90.0|-6.71|0.21||||||PF-04965842 200 mg vs Placebo at Week 5: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.||0.21|-6.71|
72360851|NCT02201524|144232938|SUPERIORITY_OR_OTHER||LS mean difference|-2.98|STANDARD_ERROR_OF_MEAN|2.035|||TWO_SIDED|90.0|-6.4|0.45||||||PF-04965842 400 mg vs Placebo at Week 5: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.||0.45|-6.40|
72360852|NCT02201524|144232938|SUPERIORITY_OR_OTHER||LS mean difference|-8.59|STANDARD_ERROR_OF_MEAN|2.167|||TWO_SIDED|90.0|-12.24|-4.95||||||PF-04965842 200 mg vs Placebo at Week 5: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.||-4.95|-12.24|
72360853|NCT02201524|144232938|SUPERIORITY_OR_OTHER||LS mean difference|-3.98|STANDARD_ERROR_OF_MEAN|2.321|||TWO_SIDED|90.0|-7.89|-0.08||||||PF-04965842 200 mg vs Placebo at Week 6: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.||-0.08|-7.89|
72360854|NCT02201524|144232938|SUPERIORITY_OR_OTHER||LS mean difference|-3.8|STANDARD_ERROR_OF_MEAN|2.304|||TWO_SIDED|90.0|-7.68|0.07||||||PF-04965842 400 mg vs Placebo at Week 6: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.||0.07|-7.68|
72360855|NCT02201524|144232938|SUPERIORITY_OR_OTHER||LS mean difference|-6.94|STANDARD_ERROR_OF_MEAN|2.412|||TWO_SIDED|90.0|-11.0|-2.89||||||PF-04965842 200 mg vs Placebo at Week 6: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.||-2.89|-11.00|
72360856|NCT02201524|144232938|SUPERIORITY_OR_OTHER||LS mean difference|-1.27|STANDARD_ERROR_OF_MEAN|2.607|||TWO_SIDED|90.0|-5.65|3.11||||||PF-04965842 200 mg vs Placebo at Week 8: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.||3.11|-5.65|
72360857|NCT02201524|144232938|SUPERIORITY_OR_OTHER||LS mean difference|-2.83|STANDARD_ERROR_OF_MEAN|2.586|||TWO_SIDED|90.0|-7.18|1.51||||||PF-04965842 400 mg vs Placebo at Week 8: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.||1.51|-7.18|
72360858|NCT02201524|144232938|SUPERIORITY_OR_OTHER||LS mean difference|-6.52|STANDARD_ERROR_OF_MEAN|2.758|||TWO_SIDED|90.0|-11.15|-1.89||||||PF-04965842 200 mg vs Placebo at Week 8: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.||-1.89|-11.15|
72360859|NCT02201524|144232939|SUPERIORITY_OR_OTHER||Difference in Percentage|-0.5|||||TWO_SIDED|90.0|-21.5|19.6||||||PF-04965842 200 mg vs Placebo at Week 1: Analysed using Asymptotic Miettinen and Nurminen method.||19.6|-21.5|
72360860|NCT02201524|144232939|SUPERIORITY_OR_OTHER||Difference in Percentage|17.9|||||TWO_SIDED|90.0|-5.9|40.3||||||PF-04965842 400 mg vs Placebo at Week 1: Analysed using Asymptotic Miettinen and Nurminen method.||40.3|-5.9|
72360861|NCT02201524|144232939|SUPERIORITY_OR_OTHER||Difference in Percentage|14.3|||||TWO_SIDED|90.0|-9.3|38.0|||Difference in Percentage Analysed using|||PF-04965842 200 mg vs Placebo at Week 1: Analysed using Asymptotic Miettinen and Nurminen method.||38.0|-9.3|
72360862|NCT02201524|144232939|SUPERIORITY_OR_OTHER||Difference in Percentage|-14.3|||||TWO_SIDED|90.0|-38.0|9.3||||||PF-04965842 200 mg vs Placebo at Week 2: Analysed using Asymptotic Miettinen and Nurminen method.||9.3|-38.0|
72360863|NCT02201524|144232939|SUPERIORITY_OR_OTHER||Difference in Percentage|1.6|||||TWO_SIDED|90.0|-25.4|29.1||||||PF-04965842 400 mg vs Placebo at Week 2: Analysed using Asymptotic Miettinen and Nurminen method.||29.1|-25.4|
72360864|NCT02201524|144232939|SUPERIORITY_OR_OTHER||Difference in Percentage|20.2|||||TWO_SIDED|90.0|-10.2|48.3||||||PF-04965842 200 mg vs Placebo at Week 2: Analysed using Asymptotic Miettinen and Nurminen method.||48.3|-10.2|
72360865|NCT02201524|144232939|SUPERIORITY_OR_OTHER||Difference in Percentage|1.9|||||TWO_SIDED|90.0|-26.7|31.0||||||PF-04965842 200 mg vs Placebo at Week 3: Analysed using Asymptotic Miettinen and Nurminen method.||31.0|-26.7|
72360866|NCT02201524|144232939|SUPERIORITY_OR_OTHER||Difference in Percentage|23.6|||||TWO_SIDED|90.0|-6.9|49.8||||||PF-04965842 400 mg vs Placebo at Week 3: Analysed using Asymptotic Miettinen and Nurminen method.||49.8|-6.9|
72360867|NCT02201524|144232939|SUPERIORITY_OR_OTHER||Difference in Percentage|67.8|||||TWO_SIDED|90.0|36.4|85.3||||||PF-04965842 200 mg vs Placebo at Week 3: Analysed using Asymptotic Miettinen and Nurminen method.||85.3|36.4|
72360868|NCT02201524|144232939|SUPERIORITY_OR_OTHER||Difference in Percentage|41.7|||||TWO_SIDED|90.0|7.6|67.1||||||PF-04965842 200 mg vs Placebo at Week 4: Analysed using Asymptotic Miettinen and Nurminen method.||67.1|7.6|
72360869|NCT02201524|144232939|SUPERIORITY_OR_OTHER||Difference in Percentage|41.7|||||TWO_SIDED|90.0|7.6|67.1||||||PF-04965842 400 mg vs Placebo at Week 4: Analysed using Asymptotic Miettinen and Nurminen method.||67.1|7.6|
72360870|NCT02201524|144232939|SUPERIORITY_OR_OTHER||Difference in Percentage|55.0|||||TWO_SIDED|90.0|19.7|77.6||||||PF-04965842 200 mg vs Placebo at Week 4: Analysed using Asymptotic Miettinen and Nurminen method.||77.6|19.7|
72360871|NCT02201524|144232939|SUPERIORITY_OR_OTHER||Difference in Percentage|12.1|||||TWO_SIDED|90.0|-21.4|43.4||||||PF-04965842 200 mg vs Placebo at Week 5: Analysed using Asymptotic Miettinen and Nurminen method.||43.4|-21.4|
72360872|NCT02201524|144232939|SUPERIORITY_OR_OTHER||Difference in Percentage|3.8|||||TWO_SIDED|90.0|-29.4|36.4||||||PF-04965842 400 mg vs Placebo at Week 5: Analysed using Asymptotic Miettinen and Nurminen method.||36.4|-29.4|
72360873|NCT02201524|144232939|SUPERIORITY_OR_OTHER||Difference in Percentage|45.5|||||TWO_SIDED|90.0|17.1|69.0||||||PF-04965842 200 mg vs Placebo at Week 5: Analysed using Asymptotic Miettinen and Nurminen method.||69.0|17.1|
72360874|NCT02201524|144232939|SUPERIORITY_OR_OTHER||Difference in Percentage|36.4|||||TWO_SIDED|90.0|1.9|63.4||||||PF-04965842 200 mg vs Placebo at Week 6: Analysed using Asymptotic Miettinen and Nurminen method.||63.4|1.9|
72360875|NCT02201524|144232939|SUPERIORITY_OR_OTHER||Difference in Percentage|14.5|||||TWO_SIDED|90.0|-21.4|47.0||||||PF-04965842 400 mg vs Placebo at Week 6: Analysed using Asymptotic Miettinen and Nurminen method.||47.0|-21.4|
72360876|NCT02201524|144232939|SUPERIORITY_OR_OTHER||Difference in Percentage|24.5|||||TWO_SIDED|90.0|-11.8|54.9||||||PF-04965842 200 mg vs Placebo at Week 6: Analysed using Asymptotic Miettinen and Nurminen method.||54.9|-11.8|
72360877|NCT02201524|144232939|SUPERIORITY_OR_OTHER||Difference in Percentage|-4.5|||||TWO_SIDED|90.0|-40.4|32.3||||||PF-04965842 200 mg vs Placebo at Week 8: Analysed using Asymptotic Miettinen and Nurminen method.||32.3|-40.4|
72360878|NCT02201524|144232939|SUPERIORITY_OR_OTHER||Difference in Percentage|13.6|||||TWO_SIDED|90.0|-23.7|48.2||||||PF-04965842 400 mg vs Placebo at Week 8: Analysed using Asymptotic Miettinen and Nurminen method.||48.2|-23.7|
72360879|NCT02201524|144232939|SUPERIORITY_OR_OTHER||Difference in Percentage|12.5|||||TWO_SIDED|90.0|-28.0|49.3||||||PF-04965842 200 mg vs Placebo at Week 8: Analysed using Asymptotic Miettinen and Nurminen method.||49.3|-28.0|
72360880|NCT02201524|144232940|SUPERIORITY_OR_OTHER||Difference in Percentage|7.1|||||TWO_SIDED|90.0|-10.2|27.0||||||PF-04965842 200 mg vs Placebo at Week 1: Analysed using Asymptotic Miettinen and Nurminen method.||27.0|-10.2|
72360881|NCT02201524|144232940|SUPERIORITY_OR_OTHER||Difference in Percentage|-7.1|||||TWO_SIDED|90.0|-27.0|10.2||||||PF-04965842 200 mg vs Placebo at Week 2: Analysed using Asymptotic Miettinen and Nurminen method.||10.2|-27.0|
72360882|NCT02201524|144232940|SUPERIORITY_OR_OTHER||Difference in Percentage|8.2|||||TWO_SIDED|90.0|-14.4|32.2||||||PF-04965842 400 mg vs Placebo at Week 2: Analysed using Asymptotic Miettinen and Nurminen method.||32.2|-14.4|
72360883|NCT02201524|144232940|SUPERIORITY_OR_OTHER||Difference in Percentage|17.9|||||TWO_SIDED|90.0|-6.7|43.6||||||PF-04965842 200 mg vs Placebo at Week 2: Analysed using Asymptotic Miettinen and Nurminen method.||43.6|-6.7|
72360884|NCT02201524|144232940|SUPERIORITY_OR_OTHER||Difference in Percentage|-7.7|||||TWO_SIDED|90.0|-28.8|12.1||||||PF-04965842 200 mg vs Placebo at Week 3: Analysed using Asymptotic Miettinen and Nurminen method.||12.1|-28.8|
72360885|NCT02201524|144232940|SUPERIORITY_OR_OTHER||Difference in Percentage|32.3|||||TWO_SIDED|90.0|5.4|55.4||||||PF-04965842 400 mg vs Placebo at Week 3: Analysed using Asymptotic Miettinen and Nurminen method.||55.4|5.4|
72360886|NCT02201524|144232940|SUPERIORITY_OR_OTHER||Difference in Percentage|28.7|||||TWO_SIDED|90.0|0.8|55.3||||||PF-04965842 200 mg vs Placebo at Week 3: Analysed using Asymptotic Miettinen and Nurminen method.||55.3|0.8|
72360887|NCT02201524|144232940|SUPERIORITY_OR_OTHER||Difference in Percentage|0.0|||||TWO_SIDED|90.0|-27.3|27.3||||||PF-04965842 200 mg vs Placebo at Week 4: Analysed using Asymptotic Miettinen and Nurminen method.||27.3|-27.3|
72360888|NCT02201524|144232940|SUPERIORITY_OR_OTHER||Difference in Percentage|33.3|||||TWO_SIDED|90.0|1.0|59.8||||||PF-04965842 400 mg vs Placebo at Week 4: Analysed using Asymptotic Miettinen and Nurminen method.||59.8|1.0|
72360889|NCT02201524|144232940|SUPERIORITY_OR_OTHER||Difference in Percentage|43.3|||||TWO_SIDED|90.0|8.8|69.3||||||PF-04965842 200 mg vs Placebo at Week 4: Analysed using Asymptotic Miettinen and Nurminen method.||69.3|8.8|
72360890|NCT02201524|144232940|SUPERIORITY_OR_OTHER||Difference in Percentage|25.0|||||TWO_SIDED|90.0|2.1|49.3||||||PF-04965842 200 mg vs Placebo at Week 5: Analysed using Asymptotic Miettinen and Nurminen method.||49.3|2.1|
72360891|NCT02201524|144232940|SUPERIORITY_OR_OTHER||Difference in Percentage|50.0|||||TWO_SIDED|90.0|25.4|71.8||||||PF-04965842 400 mg vs Placebo at Week 5: Analysed using Asymptotic Miettinen and Nurminen method.||71.8|25.4|
72360892|NCT02201524|144232940|SUPERIORITY_OR_OTHER||Difference in Percentage|66.7|||||TWO_SIDED|90.0|39.2|86.1||||||PF-04965842 200 mg vs Placebo at Week 5: Analysed using Asymptotic Miettinen and Nurminen method.||86.1|39.2|
72360893|NCT02201524|144232940|SUPERIORITY_OR_OTHER||Difference in Percentage|-9.1|||||TWO_SIDED|90.0|-36.3|18.3||||||PF-04965842 200 mg vs Placebo at Week 6: Analysed using Asymptotic Miettinen and Nurminen method.||18.3|-36.3|
72360894|NCT02201524|144232940|SUPERIORITY_OR_OTHER||Difference in Percentage|41.8|||||TWO_SIDED|90.0|6.2|68.5||||||PF-04965842 400 mg vs Placebo at Week 6: Analysed using Asymptotic Miettinen and Nurminen method.||68.5|6.2|
72360895|NCT02201524|144232940|SUPERIORITY_OR_OTHER||Difference in Percentage|31.8|||||TWO_SIDED|90.0|-2.9|60.5||||||PF-04965842 200 mg vs Placebo at Week 6: Analysed using Asymptotic Miettinen and Nurminen method.||60.5|-2.9|
72360896|NCT02201524|144232940|SUPERIORITY_OR_OTHER||Difference in Percentage|-15.9|||||TWO_SIDED|90.0|-47.8|13.7||||||PF-04965842 200 mg vs Placebo at Week 8: Analysed using Asymptotic Miettinen and Nurminen method.||13.7|-47.8|
72360897|NCT02201524|144232940|SUPERIORITY_OR_OTHER||Difference in Percentage|-6.8|||||TWO_SIDED|90.0|-40.6|24.8||||||PF-04965842 400 mg vs Placebo at Week 8: Analysed using Asymptotic Miettinen and Nurminen method.||24.8|-40.6|
72360898|NCT02201524|144232940|SUPERIORITY_OR_OTHER||Difference in Percentage|0.0|||||TWO_SIDED|90.0|-36.4|36.4||||||PF-04965842 200 mg vs Placebo at Week 8: Analysed using Asymptotic Miettinen and Nurminen method.||36.4|-36.4|
72360899|NCT02201524|144232941|SUPERIORITY_OR_OTHER||Difference in Percentage|7.1|||||TWO_SIDED|90.0|-10.2|27.0||||||PF-04965842 200 mg vs Placebo at Week 1: Analysed using Asymptotic Miettinen and Nurminen method.||27.0|-10.2|
72360900|NCT02201524|144232941|SUPERIORITY_OR_OTHER||Difference in Percentage|-7.1|||||TWO_SIDED|90.0|-27.0|10.2||||||PF-04965842 200 mg vs Placebo at Week 2: Analysed using Asymptotic Miettinen and Nurminen method.||10.2|-27.0|
72360901|NCT02201524|144232941|SUPERIORITY_OR_OTHER||Difference in Percentage|0.5|||||TWO_SIDED|90.0|-20.7|22.8||||||PF-04965842 400 mg vs Placebo at Week 2: Analysed using Asymptotic Miettinen and Nurminen method.||22.8|-20.7|
72360902|NCT02201524|144232941|SUPERIORITY_OR_OTHER||Difference in Percentage|1.2|||||TWO_SIDED|90.0|-20.3|24.8||||||PF-04965842 200 mg vs Placebo at Week 2: Analysed using Asymptotic Miettinen and Nurminen method.||24.8|-20.3|
72360903|NCT02201524|144232941|SUPERIORITY_OR_OTHER||Difference in Percentage|13.3|||||TWO_SIDED|90.0|-5.6|33.8||||||PF-04965842 400 mg vs Placebo at Week 3: Analysed using Asymptotic Miettinen and Nurminen method.||33.8|-5.6|
72360904|NCT02201524|144232941|SUPERIORITY_OR_OTHER||Difference in Percentage|36.4|||||TWO_SIDED|90.0|15.3|61.1||||||PF-04965842 200 mg vs Placebo at Week 3: Analysed using Asymptotic Miettinen and Nurminen method.||61.1|15.3|
72360905|NCT02201524|144232941|SUPERIORITY_OR_OTHER||Difference in Percentage|33.3|||||TWO_SIDED|90.0|11.3|57.3||||||PF-04965842 400 mg vs Placebo at Week 4: Analysed using Asymptotic Miettinen and Nurminen method.||57.3|11.3|
72360906|NCT02201524|144232941|SUPERIORITY_OR_OTHER||Difference in Percentage|60.0|||||TWO_SIDED|90.0|34.7|80.9||||||PF-04965842 200 mg vs Placebo at Week 4: Analysed using Asymptotic Miettinen and Nurminen method.||80.9|34.7|
72360907|NCT02201524|144232941|SUPERIORITY_OR_OTHER||Difference in Percentage|25.0|||||TWO_SIDED|90.0|2.1|49.3||||||PF-04965842 400 mg vs Placebo at Week 5: Analysed using Asymptotic Miettinen and Nurminen method.||49.3|2.1|
72360908|NCT02201524|144232941|SUPERIORITY_OR_OTHER||Difference in Percentage|44.4|||||TWO_SIDED|90.0|19.4|70.2||||||PF-04965842 200 mg vs Placebo at Week 5: Analysed using Asymptotic Miettinen and Nurminen method.||70.2|19.4|
72360909|NCT02201524|144232941|SUPERIORITY_OR_OTHER||Difference in Percentage|20.0|||||TWO_SIDED|90.0|-2.7|46.6||||||PF-04965842 400 mg vs Placebo at Week 6: Analysed using Asymptotic Miettinen and Nurminen method.||46.6|-2.7|
72360910|NCT02201524|144232941|SUPERIORITY_OR_OTHER||Difference in Percentage|30.0|||||TWO_SIDED|90.0|6.4|56.4||||||PF-04965842 200 mg vs Placebo at Week 6: Analysed using Asymptotic Miettinen and Nurminen method.||56.4|6.4|
72360911|NCT02201524|144232941|SUPERIORITY_OR_OTHER||Difference in Percentage|25.0|||||TWO_SIDED|90.0|-4.9|54.9||||||PF-04965842 200 mg vs Placebo at Week 8: Analysed using Asymptotic Miettinen and Nurminen method.||54.9|-4.9|
72360912|NCT02201524|144232942|SUPERIORITY_OR_OTHER||Difference in Percentage|13.3|||||TWO_SIDED|90.0|-4.4|33.8||||||PF-04965842 200 mg vs Placebo at Week 1: Analysed using Asymptotic Miettinen and Nurminen method.||33.8|-4.4|
72360913|NCT02201524|144232942|SUPERIORITY_OR_OTHER||Difference in Percentage|12.5|||||TWO_SIDED|90.0|-5.2|32.0||||||PF-04965842 400 mg vs Placebo at Week 1: Analysed using Asymptotic Miettinen and Nurminen method.||32.0|-5.2|
72360914|NCT02201524|144232942|SUPERIORITY_OR_OTHER||Difference in Percentage|7.1|||||TWO_SIDED|90.0|-10.2|27.0||||||PF-04965842 200 mg vs Placebo at Week 1: Analysed using Asymptotic Miettinen and Nurminen method.||27.0|-10.2|
72360915|NCT02201524|144232942|SUPERIORITY_OR_OTHER||Difference in Percentage|21.4|||||TWO_SIDED|90.0|-3.2|45.5||||||PF-04965842 200 mg vs Placebo at Week 2: Analysed using Asymptotic Miettinen and Nurminen method.||45.5|-3.2|
72360916|NCT02201524|144232942|SUPERIORITY_OR_OTHER||Difference in Percentage|15.9|||||TWO_SIDED|90.0|-8.1|40.7||||||PF-04965842 400 mg vs Placebo at Week 2: Analysed using Asymptotic Miettinen and Nurminen method.||40.7|-8.1|
72360917|NCT02201524|144232942|SUPERIORITY_OR_OTHER||Difference in Percentage|34.5|||||TWO_SIDED|90.0|7.3|59.4||||||PF-04965842 200 mg vs Placebo at Week 2: Analysed using Asymptotic Miettinen and Nurminen method.||59.4|7.3|
72360918|NCT02201524|144232942|SUPERIORITY_OR_OTHER||Difference in Percentage|17.9|||||TWO_SIDED|90.0|-11.2|45.5||||||PF-04965842 200 mg vs Placebo at Week 3: Analysed using Asymptotic Miettinen and Nurminen method.||45.5|-11.2|
72360919|NCT02201524|144232942|SUPERIORITY_OR_OTHER||Difference in Percentage|31.3|||||TWO_SIDED|90.0|1.7|55.7||||||PF-04965842 400 mg vs Placebo at Week 3: Analysed using Asymptotic Miettinen and Nurminen method.||55.7|1.7|
72360920|NCT02201524|144232942|SUPERIORITY_OR_OTHER||Difference in Percentage|30.1|||||TWO_SIDED|90.0|-1.2|57.4|||Difference in Percentage Analysed using|||PF-04965842 200 mg vs Placebo at Week 3: Analysed using Asymptotic Miettinen and Nurminen method.||57.4|-1.2|
72360921|NCT02201524|144232942|SUPERIORITY_OR_OTHER||Difference in Percentage|25.0|||||TWO_SIDED|90.0|-6.4|52.5||||||PF-04965842 200 mg vs Placebo at Week 4: Analysed using Asymptotic Miettinen and Nurminen method.||52.5|-6.4|
72360922|NCT02201524|144232942|SUPERIORITY_OR_OTHER||Difference in Percentage|41.7|||||TWO_SIDED|90.0|8.7|66.7||||||PF-04965842 400 mg vs Placebo at Week 4: Analysed using Asymptotic Miettinen and Nurminen method.||66.7|8.7|
72360923|NCT02201524|144232942|SUPERIORITY_OR_OTHER||Difference in Percentage|53.3|||||TWO_SIDED|90.0|18.5|76.6||||||PF-04965842 200 mg vs Placebo at Week 4: Analysed using Asymptotic Miettinen and Nurminen method.||76.6|18.5|
72360924|NCT02201524|144232942|SUPERIORITY_OR_OTHER||Difference in Percentage|6.1|||||TWO_SIDED|90.0|-26.1|36.6||||||PF-04965842 200 mg vs Placebo at Week 5: Analysed using Asymptotic Miettinen and Nurminen method.||36.6|-26.1|
72360925|NCT02201524|144232942|SUPERIORITY_OR_OTHER||Difference in Percentage|14.4|||||TWO_SIDED|90.0|-18.9|44.5||||||PF-04965842 400 mg vs Placebo at Week 5: Analysed using Asymptotic Miettinen and Nurminen method.||44.5|-18.9|
72360926|NCT02201524|144232942|SUPERIORITY_OR_OTHER||Difference in Percentage|50.5|||||TWO_SIDED|90.0|12.9|75.3||||||PF-04965842 200 mg vs Placebo at Week 5: Analysed using Asymptotic Miettinen and Nurminen method.||75.3|12.9|
72360927|NCT02201524|144232942|SUPERIORITY_OR_OTHER||Difference in Percentage|9.1|||||TWO_SIDED|90.0|-25.2|41.4||||||PF-04965842 200 mg vs Placebo at Week 6: Analysed using Asymptotic Miettinen and Nurminen method.||41.4|-25.2|
72360928|NCT02201524|144232942|SUPERIORITY_OR_OTHER||Difference in Percentage|3.6|||||TWO_SIDED|90.0|-30.5|37.3||||||PF-04965842 400 mg vs Placebo at Week 6: Analysed using Asymptotic Miettinen and Nurminen method.||37.3|-30.5|
72360929|NCT02201524|144232942|SUPERIORITY_OR_OTHER||Difference in Percentage|13.6|||||TWO_SIDED|90.0|-21.9|46.2||||||PF-04965842 200 mg vs Placebo at Week 6: Analysed using Asymptotic Miettinen and Nurminen method.||46.2|-21.9|
72360930|NCT02201524|144232942|SUPERIORITY_OR_OTHER||Difference in Percentage|2.3|||||TWO_SIDED|90.0|-33.2|34.6||||||PF-04965842 200 mg vs Placebo at Week 8: Analysed using Asymptotic Miettinen and Nurminen method.||34.6|-33.2|
72360931|NCT02201524|144232942|SUPERIORITY_OR_OTHER||Difference in Percentage|20.5|||||TWO_SIDED|90.0|-17.6|51.9||||||PF-04965842 400 mg vs Placebo at Week 8: Analysed using Asymptotic Miettinen and Nurminen method.||51.9|-17.6|
72360932|NCT02201524|144232942|SUPERIORITY_OR_OTHER||Difference in Percentage|12.5|||||TWO_SIDED|90.0|-26.4|48.1||||||PF-04965842 200 mg vs Placebo at Week 8: Analysed using Asymptotic Miettinen and Nurminen method.||48.1|-26.4|
72360933|NCT01018030|144232976|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.386||||0.008|TWO_SIDED|95.0|-0.67|-0.1|||ANCOVA||The estimation for least squares mean was adjusted for baseline value, country, allergic rhinitis status, age, and gender.|||-0.10|-0.67|0.008
72360934|NCT01018030|144232976|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.357||||0.014|TWO_SIDED|95.0|-0.64|-0.07|||ANCOVA||The estimation for least squares mean was adjusted for baseline value, country, allergic rhinitis status, age, and gender.|||-0.07|-0.64|0.014
72360935|NCT00189540|144232993|SUPERIORITY_OR_OTHER_LEGACY|||||||0.35||95.0|||||ANCOVA|||Comparison made is the difference from baseline at Month 3.||||0.35
72360936|NCT00189540|144232993|SUPERIORITY_OR_OTHER_LEGACY|||||||0.17||95.0|||||ANCOVA|||Comparison made is the difference from baseline at Month 6.||||0.17
72360937|NCT00189540|144232994|SUPERIORITY_OR_OTHER_LEGACY|||||||0.55||95.0|||||Fisher Exact|||The comparison of groups at Month 3||||0.55
72360938|NCT00189540|144232994|SUPERIORITY_OR_OTHER_LEGACY|||||||0.28||95.0|||||Fisher Exact|||The comparison of groups at Month 6.||||0.28
72360939|NCT00189540|144232995|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2||95.0|||||ANCOVA|||Comparison between groups at Month 3||||0.2
72360940|NCT00189540|144232995|SUPERIORITY_OR_OTHER_LEGACY|||||||0.04||95.0|||||ANCOVA|||Comparison between groups at Month 6||||0.04
72360941|NCT00189540|144232996|SUPERIORITY_OR_OTHER_LEGACY|||||||1||95.0|||||Fisher Exact|||||||1.00
72360942|NCT00189540|144232997|SUPERIORITY_OR_OTHER_LEGACY|||||||0.77||95.0|||||ANCOVA|||Comparison at Month 3||||0.77
72360943|NCT00189540|144232997|SUPERIORITY_OR_OTHER_LEGACY|||||||0.45||95.0|||||ANCOVA|||Comparison at Month 6||||0.45
72360944|NCT00189540|144232998|SUPERIORITY_OR_OTHER_LEGACY|||||||0.06||95.0|||||ANCOVA|||Comparison between groups for mean TBI at Month 3 versus baseline.||||0.06
72360945|NCT00189540|144232998|SUPERIORITY_OR_OTHER_LEGACY|||||||0.05||95.0|||||ANCOVA|||Comparison between groups for mean TBI at Month 6 versus baseline.||||0.05
72360946|NCT02546609|144233019|OTHER|||||||0.0572|||||||ANCOVA|||Analysis of variance (ANOVA) model: with treatment group as the factor. Placebo is used as the reference group.||||0.0572
72360947|NCT02546609|144233019|OTHER|||||||0.377|||||||ANCOVA|||Analysis of variance (ANOVA) model: with treatment group as the factor. Placebo is used as the reference group.||||0.3770
72360948|NCT02546609|144233020|OTHER|||||||0.3811|||||||Mixed Effect Model Repeat Measurement|||MMRM model: with treatment group, visit, and treatment-by-visit interaction as fixed effects, the baseline value of the response variable as a covariate, and subject as a random effect. Placebo is used as the reference group.||||0.3811
72360949|NCT02546609|144233020|OTHER|||||||0.8479|||||||Mixed Effect Model Repeat Measurement|||MMRM model: with treatment group, visit, and treatment-by-visit interaction as fixed effects, the baseline value of the response variable as a covariate, and subject as a random effect. Placebo is used as the reference group.||||0.8479
72360950|NCT02546609|144233021|OTHER|||||||0.7742|||||||Mixed effect Model Repeat Measurement|||MMRM model: with treatment group, visit, and treatment-by-visit interaction as fixed effects, the baseline value of the response variable as a covariate, and subject as a random effect. Placebo is used as the reference group.||||0.7742
72360951|NCT02546609|144233021|OTHER|||||||0.6666|||||||Mixed effect Model Repeat Measurement|||MMRM model: with treatment group, visit, and treatment-by-visit interaction as fixed effects, the baseline value of the response variable as a covariate, and subject as a random effect. Placebo is used as the reference group.||||0.6666
72360952|NCT02546609|144233022|OTHER|||||||0.002|||||||MMRM|||MMRM model: with treatment group, visit, and treatment-by-visit interaction as fixed effects, the baseline value of the response variable as a covariate, and subject as a random effect. Placebo is used as the reference group.||||0.0020
72360953|NCT02546609|144233022|OTHER|||||||0.0164|||||||MMRM|||MMRM model: with treatment group, visit, and treatment-by-visit interaction as fixed effects, the baseline value of the response variable as a covariate, and subject as a random effect. Placebo is used as the reference group.||||0.0164
72360954|NCT02546609|144233023|OTHER|||||||0.4099|||||||MMRM|||MMRM model: with treatment group, visit, and treatment-by-visit interaction as fixed effects, the baseline value of the response variable as a covariate, and subject as a random effect. Placebo is used as the reference group.||||0.4099
72360955|NCT02546609|144233023|OTHER|||||||0.1455|||||||MMRM|||MMRM model: with treatment group, visit, and treatment-by-visit interaction as fixed effects, the baseline value of the response variable as a covariate, and subject as a random effect. Placebo is used as the reference group.||||0.1455
72360956|NCT02546609|144233024|OTHER|||||||0.2559|||||||MMRM|||MMRM model: with treatment group, visit, and treatment-by-visit interaction as fixed effects, the baseline value of the response variable as a covariate, and subject as a random effect. Placebo is used as the reference group.||||0.2559
72360957|NCT02546609|144233024|OTHER|||||||0.9776|||||||MMRM|||MMRM model: with treatment group, visit, and treatment-by-visit interaction as fixed effects, the baseline value of the response variable as a covariate, and subject as a random effect. Placebo is used as the reference group.||||0.9776
72360958|NCT02546609|144233025|OTHER|||||||0.2265|||||||MMRM|||MMRM model: with treatment group, visit, and treatment-by-visit interaction as fixed effects, the baseline value of the response variable as a covariate, and subject as a random effect. Placebo is used as the reference group.||||0.2265
72360959|NCT02546609|144233025|OTHER|||||||0.8366|||||||MMRM|||MMRM model: with treatment group, visit, and treatment-by-visit interaction as fixed effects, the baseline value of the response variable as a covariate, and subject as a random effect. Placebo is used as the reference group.||||0.8366
72360960|NCT02546609|144233026|OTHER|||||||0.347|||||||MMRM|||MMRM model: with treatment group, visit, and treatment-by-visit interaction as fixed effects, the baseline value of the response variable as a covariate, and subject as a random effect. Placebo is used as the reference group.||||0.3470
72360961|NCT02546609|144233026|OTHER|||||||0.6221|||||||MMRM|||MMRM model: with treatment group, visit, and treatment-by-visit interaction as fixed effects, the baseline value of the response variable as a covariate, and subject as a random effect. Placebo is used as the reference group.||||0.6221
72360962|NCT02546609|144233027|OTHER|||||||0.347|||||||MMRM|||MMRM model: with treatment group, visit, and treatment-by-visit interaction as fixed effects, the baseline value of the response variable as a covariate, and subject as a random effect. Placebo is used as the reference group.||||0.3470
72360963|NCT02546609|144233027|OTHER|||||||0.6221|||||||MMRM|||MMRM model: with treatment group, visit, and treatment-by-visit interaction as fixed effects, the baseline value of the response variable as a covariate, and subject as a random effect. Placebo is used as the reference group.||||0.6221
72360964|NCT02546609|144233028|OTHER|||||||0.0129|||||||MMRM|||MMRM model: with treatment group, visit, and treatment-by-visit interaction as fixed effects, the baseline value of the response variable as a covariate, and subject as a random effect. Placebo is used as the reference group.||||0.0129
72360965|NCT02546609|144233028|OTHER|||||||0.4316|||||||MMRM|||MMRM model: with treatment group, visit, and treatment-by-visit interaction as fixed effects, the baseline value of the response variable as a covariate, and subject as a random effect. Placebo is used as the reference group.||||0.4316
72360966|NCT02546609|144233029|OTHER|MMRM model: with treatment group, visit, and treatment-by-visit interaction as fixed effects, the baseline value of the response variable as a covariate, and subject as a random effect. Placebo is used as the reference group.||||||0.1946|||||||MMRM|||||||0.1946
72360967|NCT02546609|144233029|OTHER|||||||0.4697|||||||MMRM|||MMRM model: with treatment group, visit, and treatment-by-visit interaction as fixed effects, the baseline value of the response variable as a covariate, and subject as a random effect. Placebo is used as the reference group.||||0.4697
72360968|NCT02546609|144233030|OTHER|||||||0.3474|||||||MMRM|||MMRM model: with treatment group, visit, and treatment-by-visit interaction as fixed effects, the baseline value of the response variable as a covariate, and subject as a random effect. Placebo is used as the reference group.||||0.3474
72360969|NCT02546609|144233030|OTHER|||||||0.8832|||||||MMRM|||MMRM model: with treatment group, visit, and treatment-by-visit interaction as fixed effects, the baseline value of the response variable as a covariate, and subject as a random effect. Placebo is used as the reference group.||||0.8832
72360970|NCT01292486|144233050|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin was 2 days.|Median Difference (Final Values)|0.0|||<|0.025|TWO_SIDED|95.0|0.0|0.0|||Hodges-Lehman estimation|||The null hypothesis was that the median day to neutrophil recovery in this study was more than two days longer than historical controls.||0.0|0.0|<0.025
72360971|NCT04369404|144233057|SUPERIORITY|We hypothesize that participants who received the decision aid will have higher knowledge. This is pilot study, thus we did not have a power calculation.|Mean Difference (Final Values)|12.0||||0.06|TWO_SIDED|95.0|0.7|24.6|||t-test, 2 sided|||||24.6|0.7|0.06
72360972|NCT04369404|144233058|OTHER||Pearson Chi-Square|2.97||||0.085|TWO_SIDED||||||Chi-squared|||"a chisquare test was conducted to determine if the proportion of treatment unsure responses were different between the usual care and intervention arms."||||0.085
72360973|NCT04369404|144233059|OTHER||Pearson Chi-Square|1.524||||0.47|TWO_SIDED||||||Chi-squared|||||||0.47
72360974|NCT01553084|144233066|SUPERIORITY||Odds Ratio (OR)|1.2||||0.3623|TWO_SIDED|95.0|0.8|1.7|||Regression, Logistic|||Combination NRT will be compared statististically versus Nicotine patch only (the reference or control group).||1.7|0.8|.3623
72360975|NCT01553084|144233066|SUPERIORITY||Odds Ratio (OR)|0.9||||0.1947|TWO_SIDED|95.0|0.6|1.2|||Regression, Logistic|||Varenicline will be compared statististically versus Nicotine patch only (the reference or control group).||1.2|0.6|.1947
72360976|NCT01553084|144233067|SUPERIORITY||Hazard Ratio (HR)|0.915||||0.3613|TWO_SIDED|95.0|0.756|1.107|||Regression, Cox|||||1.107|.756|.3613
72360977|NCT01553084|144233067|SUPERIORITY||Hazard Ratio (HR)|0.943||||0.5503|TWO_SIDED|95.0|0.779|1.142|||Regression, Cox|||||1.142|.779|.5503
72360978|NCT01553084|144233068|SUPERIORITY||Odds Ratio (OR)|1.5||||0.03|TWO_SIDED|95.0|1.1|2.2|||Regression, Logistic|||||2.2|1.1|.03
72360979|NCT01553084|144233068|SUPERIORITY||Odds Ratio (OR)|0.8||||0.19|TWO_SIDED|95.0|0.6|1.1|||Regression, Logistic|||||1.1|0.6|.19
72360980|NCT01553084|144233069|SUPERIORITY||Mean Difference (Final Values)|-0.00612|STANDARD_ERROR_OF_MEAN|0.00625||0.3282|TWO_SIDED||||||t-test, 2 sided|df=710||||||.3282
72360981|NCT03988400|144233070|SUPERIORITY|||||||1||||||The a priori threshold for statistical significance was 0.05.|Fisher Exact|||||||1
72360982|NCT03988400|144233071|SUPERIORITY|||||||0.017||||||The a priori threshold for statistical significance was 0.05.|Wilcoxon (Mann-Whitney)|||||||0.017
72360983|NCT03988400|144233072|SUPERIORITY|||||||1||||||The a priori threshold for statistical significance was 0.05.|Fisher Exact|||||||1
72360984|NCT03988400|144233073|SUPERIORITY|||||||0.72||||||The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|||||||0.72
72360985|NCT03988400|144233074|SUPERIORITY|||||||0.001||||||The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|||||||0.001
72360986|NCT03988400|144233075|SUPERIORITY|||||||0.68||||||The a priori threshold for statistical significance was 0.05.|Wilcoxon (Mann-Whitney)|||||||0.68
72360987|NCT03988400|144233076|SUPERIORITY|||||||0.25||||||The a priori threshold for statistical significance was 0.05|t-test, 2 sided|||||||0.25
72360988|NCT03988400|144233077|SUPERIORITY|||||||0.69||||||The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|||||||0.69
72360989|NCT03988400|144233078|SUPERIORITY|||||||0.2||||||The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|||||||0.20
72360990|NCT03988400|144233079|SUPERIORITY|||||||0.62||||||The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|||||||0.62
72360991|NCT04201431|144233085|OTHER|Comparison of pooled data from Groups 1 and 2 volunteers who completed primary CHMI with pooled data of infectivity controls undergoing primary CHMI from VAC069 study running in parallel (NCT03797989).||||||0.01||||||Two tailed p value reported for Mann-Whitney test comparing infectivity controls with vaccinees|Wilcoxon (Mann-Whitney)|||Comparison of parasite multiplication rate in vaccinated subjects compared to infectivity controls in a blood-stage controlled human malaria infection model||||0.01
72360992|NCT00988832|144233115|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANOVA|||||||<0.0001
72360993|NCT00988832|144233116|SUPERIORITY_OR_OTHER|||||||0.0004||95.0|||||ANOVA|||||||0.0004
72360994|NCT00988832|144233117|SUPERIORITY_OR_OTHER|||||||0.0041||95.0|||||ANOVA|||||||0.0041
72360995|NCT00988832|144233118|SUPERIORITY_OR_OTHER|||||||0.0423||95.0|||||ANOVA|||||||0.0423
72360996|NCT00988832|144233119|SUPERIORITY_OR_OTHER|||||||0.0006||95.0|||||ANOVA|||||||0.0006
72360997|NCT00988832|144233120|SUPERIORITY_OR_OTHER|||||||0.0014||95.0|||||ANOVA|||||||0.0014
72360998|NCT00988832|144233122|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANOVA|||||||<0.0001
72360999|NCT01283555|144233142|SUPERIORITY_OR_OTHER|||||||0.487||95.0||||The p-value presented here represents a comparison of the total number of non-iatrogenic findings at baseline and after one week of product use.|Fisher Exact|||Fishers exact test was used to compare the frequency of non-iatrogenic colposcopic findings at baseline and follow-up visits (after one week of twice-daily product use).||||0.4870
72361000|NCT04267380|144233146|SUPERIORITY|||||||0.73|||||||t-test, 2 sided|||||||0.73
72361001|NCT04267380|144233147|SUPERIORITY|||||||0.97|||||||t-test, 2 sided|||||||0.97
72361002|NCT04267380|144233148|SUPERIORITY|||||||0.26|||||||Chi-squared|||||||0.26
72361003|NCT04267380|144233149|SUPERIORITY|||||||0.23|||||||Chi-squared|||||||0.23
72361004|NCT04267380|144233150|SUPERIORITY|||||||0.33|||||||Chi-squared|||||||0.33
72361005|NCT04267380|144233151|SUPERIORITY|||||||0.07|||||||Chi-squared|||||||0.07
72361006|NCT04267380|144233152|SUPERIORITY|||||||0.68|||||||Chi-squared|||||||0.68
72361007|NCT04267380|144233153|SUPERIORITY|||||||0.68|||||||Chi-squared|||||||0.68
72361008|NCT04267380|144233155|SUPERIORITY|||||||0.45|||||||t-test, 2 sided|||||||0.45
72361009|NCT04267380|144233156|SUPERIORITY|||||||0.53|||||||t-test, 2 sided|||||||0.53
72361010|NCT04267380|144233157|SUPERIORITY|||||||0.86|||||||t-test, 2 sided|||||||0.86
72361011|NCT04267380|144233158|SUPERIORITY|||||||0.83|||||||t-test, 2 sided|||||||0.83
72361012|NCT04267380|144233159|SUPERIORITY|||||||0.67|||||||t-test, 2 sided|||||||0.67
72361013|NCT04267380|144233160|SUPERIORITY|||||||0.86|||||||t-test, 2 sided|||||||0.86
72361014|NCT04267380|144233161|SUPERIORITY|||||||0.78|||||||t-test, 2 sided|||||||0.78
72361015|NCT04267380|144233162|SUPERIORITY|||||||0.99|||||||t-test, 2 sided|||||||0.99
72361016|NCT04267380|144233163|SUPERIORITY|||||||0.11|||||||Chi-squared|||||||0.11
72361017|NCT04267380|144233164|SUPERIORITY|||||||0.63|||||||Chi-squared|||||||0.63
72361018|NCT04267380|144233165|SUPERIORITY|||||||0.25|||||||Chi-squared|||||||0.25
72361019|NCT00310765|144233172|SUPERIORITY_OR_OTHER_LEGACY|The group-by-time interaction result from repeated-measure analysis of variance modeling was used to evaluate whether the two study groups differed regarding the pain score change that occurred across each of the two study phases (weeks 0-7 and weeks 7-10). To conform to the analysis of variance assumption of distributional normality, the pain scores were square root transformed before the analysis.|Mean Difference (Net)|2.0|STANDARD_DEVIATION|1.5|<|0.05|TWO_SIDED|95.0|0.0|4.0|||ANOVA|||The number of patients required per treatment group to achieve a \>80% power with an alpha=0.05 were based on exact rates from reference articles cited in the paper. Patients were randomly assigned to active drug (pregabalin) or look alike placebo.||4.0|0.0|<0.05
72361020|NCT00310765|144233173|SUPERIORITY_OR_OTHER_LEGACY|The group-by-time interaction result from repeated-measures analysis of variance modeling was used to evaluate whether the two study groups differed regarding the sleep score change that occurred during the two study phases (weeks 0-7 and weeks 7-11. to conform to the analysis of variance assumption of distributional normality the sleep scores were square root transformed before the analysis.|Mean Difference (Net)|2.0|STANDARD_DEVIATION|1.5|<|0.05|TWO_SIDED|95.0|0.0|4.0|||ANOVA|||The number of patients required per treatment group to achieve a \>80% power with an alpha=0.05 were based on the exact rates from the reference articles cited in the paper.||4.0|0.0|<0.05
72361021|NCT01841281|144233224|OTHER|||||||0.78||||||The p-value is for the interaction term|testing for interaction term|||||||0.78
72361022|NCT01841281|144233225|OTHER|||||||0.09||||||The p-value is for the interaction term|testing for interaction term|||The treatment effect was tested as an interaction term between treatment and FeNO. The null hypothesis is the effect of treatment is stratified by the FeNO status. We used a regression model instead of t-test or Wilcoxon signed-rank test in order to control period and carry-over effect which is common in a cross-over study design||||0.09
72361023|NCT02891174|144233226|EQUIVALENCE|margin=10 mmHg|Mean Difference (Final Values)|1.0|||||TWO_SIDED|95.0|-3.7|5.7|||||The adjusted mean difference between ibuprofen and acetaminophen is presented here. The adjusted mean difference was calculated using a linear mixed model adjusting for time period by intention-to-treat principles.|||5.7|-3.7|
72361024|NCT02891174|144233227|SUPERIORITY|||||||0.59||||||Abdominal pain|t-test, 2 sided|||Change in abdominal pain||||0.59
72361025|NCT02891174|144233227|SUPERIORITY|||||||0.91||||||Perineal pain|t-test, 2 sided|||Change in perineal pain||||0.91
72361026|NCT02891174|144233227|SUPERIORITY|||||||0.88||||||Overall pain|t-test, 2 sided|||Change in overall pain||||0.88
72361027|NCT02891174|144233228|OTHER|||||||0.76|||||||t-test, 2 sided|||||||0.76
72361028|NCT02891174|144233229|SUPERIORITY|||||||0.02|||||||Wilcoxon (Mann-Whitney)|||First intervention (24 hours)||||0.02
72361029|NCT02891174|144233229|SUPERIORITY|||||||0.06|||||||Wilcoxon (Mann-Whitney)|||Second intervention (24 hours)||||0.06
72361030|NCT02891174|144233229|SUPERIORITY|||||||0.04|||||||Wilcoxon (Mann-Whitney)|||Overall satisfaction with pain control during study period||||0.04
72361031|NCT04516746|144233251|SUPERIORITY||Vaccine efficacy|73.98|||<|0.001|TWO_SIDED|95.0|65.34|80.47|||Poisson regression with robust variance|||The 95% confidence interval (CI) and p-value were estimated based on Poisson regression with robust variance (including study arm and stratification factor \[age group at informed consent\] as covariates, and log of the follow up time as an offset).||80.47|65.34|<0.001
72361032|NCT04516746|144233255|SUPERIORITY||Vaccine efficacy|64.32|||<|0.001|TWO_SIDED|95.0|56.05|71.03|||Poisson regression with robust variance|||The 95% CI and p-value were estimated based on Poisson regression with robust variance (including study arm and stratification factor \[age group at informed consent\] as covariates, and log of the follow up time as an offset).||71.03|56.05|<0.001
72361033|NCT04516746|144233256|SUPERIORITY||Vaccine efficacy|69.65|||<|0.001|TWO_SIDED|95.0|60.68|76.57|||Poisson regression with robust variance|||The 95% CI and p-value were estimated based on Poisson regression with robust variance (including study arm and stratification factor \[age group at informed consent\] as covariates, and log of the follow up time as an offset).||76.57|60.68|<0.001
72361034|NCT04516746|144233257|SUPERIORITY||Vaccine efficacy|70.7|||<|0.001|TWO_SIDED|95.0|61.62|77.64|||Poisson regression with robust variance|||The 95% CI and p-value were estimated based on Poisson regression with robust variance (including study arm and stratification factor \[age group at informed consent\] as covariates, and log of the follow up time as an offset).||77.64|61.62|<0.001
72361035|NCT04516746|144233258|SUPERIORITY||Vaccine efficacy|73.68|||<|0.001|TWO_SIDED|95.0|65.13|80.13|||Poisson regression with robust variance|||The 95% CI and p-value were estimated based on Poisson regression with robust variance (including study arm and stratification factor \[age group at informed consent\] as covariates, and log of the follow up time as an offset).||80.13|65.13|<0.001
72361036|NCT04516746|144233259|SUPERIORITY||Vaccine efficacy|100.0|||<|0.001|ONE_SIDED|97.5|71.62||||Poisson regression exact conditional|||The exact 1-sided 97.5% CI and p-value were estimated based on stratified Poisson regression with exact conditional method (including study arm and stratification factor \[age group at informed consent\] as strata factor and log of total number of participants for each combination of study arm and strata as an offset).|||71.62|<0.001
72361037|NCT04516746|144233260|SUPERIORITY||Vaccine efficacy|84.97|||<|0.001|TWO_SIDED|95.0|58.97|94.5|||Poisson regression with robust variance|||The 95% CI were estimated based on Poisson regression with robust variance (including study arm and age group at screening (18-65 years, ≥ 65 years) as covariates and log of the follow-up time as an offset).||94.50|58.97|<0.001
72361038|NCT04516746|144233261|SUPERIORITY||Vaccine efficacy|94.8||||0.005|TWO_SIDED|95.0|58.98|99.34|||Poisson regression with robust variance|||The 95% CI and p-value were estimated based on Poisson regression with robust variance (including study arm and stratification factor \[age group at informed consent\] as covariates, and log of the follow up time as an offset).||99.34|58.98|0.005
72361039|NCT04516746|144233268|SUPERIORITY||Vaccine efficacy|54.47|||||TWO_SIDED|95.0|46.48|61.26||||||The 95% CI were estimated based on Poisson regression with robust variance (including study arm and age group at screening (18-65 years, ≥ 65 years) as covariates and log of the follow-up time as an offset).||61.26|46.48|
72361040|NCT00904943|144233278|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of the LS Mean (test/ref x 100)|104.27|||||TWO_SIDED||||||||Bioequivalence is established when Ratio of the Mean falls within 80-125.|||||
72361041|NCT00904943|144233279|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of the LS Mean (test/ref x 100)|102.35|||||TWO_SIDED||||||||Bioequivalence is established when Ratio of the Least Squares Mean falls within 80-125.|||||
72361042|NCT00904943|144233280|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of the LS Mean (test/ref x 100)|103.66|||||TWO_SIDED||||||||Bioequivalence is established when Ratio of the Least Squares Mean falls within 80-125.|||||
72361043|NCT04231669|144233302|SUPERIORITY|||||||0.05|||||||Linear Mixed-effects regression|||||||0.05
72361044|NCT03583099|144233319|SUPERIORITY||Difference in proportion|4.0||||0.47|TWO_SIDED|95.0|-6.9|15.0|||generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||15.0|-6.9|0.47
72361045|NCT03583099|144233320|SUPERIORITY||Difference in proportion|10.4||||0.05|TWO_SIDED|95.0|0.1|20.7|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education|||20.7|0.1|0.05
72361046|NCT03583099|144233321|SUPERIORITY||Difference in proportion|1.3||||0.75|TWO_SIDED|95.0|-6.7|9.2|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||9.2|-6.7|0.75
72361047|NCT03583099|144233322|SUPERIORITY||Difference in proportion|-2.7||||0.54|TWO_SIDED|95.0|-11.5|6.1|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education|||6.1|-11.5|0.54
72361048|NCT03583099|144233323|SUPERIORITY||Difference in proportion|5.1||||0.16|TWO_SIDED|95.0|-2.1|12.3|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||12.3|-2.1|0.16
72361049|NCT03583099|144233324|SUPERIORITY||Difference in proportion|-0.6||||0.82|TWO_SIDED|95.0|-6.4|5.1|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||5.1|-6.4|0.82
72361050|NCT03583099|144233325|SUPERIORITY||Difference in proportion|-6.3||||0.06|TWO_SIDED|95.0|-13.0|0.4|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||0.4|-13.0|0.06
72361051|NCT03583099|144233326|SUPERIORITY||Difference in proportion|-2.5||||0.68|TWO_SIDED|95.0|-14.5|9.5|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education|||9.5|-14.5|0.68
72361052|NCT03583099|144233327|SUPERIORITY||Difference in proportion|13.3||||0.19|TWO_SIDED|95.0|-6.72|33.38|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education|||33.38|-6.72|0.19
72361053|NCT03583099|144233328|SUPERIORITY||Difference in proportion|0.85||||0.93|TWO_SIDED|95.0|-17.82|19.52|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education|||19.52|-17.82|0.93
72361054|NCT03583099|144233329|SUPERIORITY||Difference in proportion|6.83||||0.45|TWO_SIDED|95.0|-10.84|24.5|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education|||24.50|-10.84|0.45
72361055|NCT03583099|144233330|SUPERIORITY||Difference in proportion|7.6||||0.41|TWO_SIDED|95.0|-10.58|25.78|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||25.78|-10.58|0.41
72361056|NCT03583099|144233331|SUPERIORITY||Difference in proportion|1.85||||0.81|TWO_SIDED|95.0|-13.17|16.88|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||16.88|-13.17|0.81
72361057|NCT03583099|144233332|SUPERIORITY||Difference in proportion|8.01||||0.51|TWO_SIDED|95.0|-15.38|31.4|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||31.40|-15.38|0.51
72361058|NCT03583099|144233333|SUPERIORITY||Difference in proportion|-10.34||||0.41|TWO_SIDED|95.0|-34.78|14.09|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||14.09|-34.78|0.41
72361059|NCT03583099|144233334|SUPERIORITY||Difference in proportion|-3.94||||0.76|TWO_SIDED|95.0|-31.03|23.16|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||23.16|-31.03|0.76
72361060|NCT03583099|144233335|SUPERIORITY||Difference in proportion|-0.76||||0.95|TWO_SIDED|95.0|-25.36|23.83|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||23.83|-25.36|0.95
72361061|NCT03583099|144233336|SUPERIORITY||Difference in means|-0.32||||0.55|TWO_SIDED|95.0|-2.01|1.36||The p-value is adjusted for baseline CAT score.|Mixed Models Analysis||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||1.36|-2.01|0.55
72361062|NCT03583099|144233337|SUPERIORITY||Difference in proportion|8.7||||0.05|TWO_SIDED|95.0|-0.1|17.4|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||17.4|-0.1|0.05
72361063|NCT03583099|144233338|SUPERIORITY||Difference in proportion|1.81||||0.88|TWO_SIDED|95.0|-21.47|25.08|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||25.08|-21.47|0.88
72361064|NCT03583099|144233339|SUPERIORITY||Difference in proportion|-5.62||||0.53|TWO_SIDED|95.0|-23.21|11.97|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||11.97|-23.21|0.53
72361065|NCT03583099|144233340|SUPERIORITY||Difference in proportion|10.68||||0.24|TWO_SIDED|95.0|-7.27|28.63|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education|||28.63|-7.27|0.24
72361066|NCT03583099|144233341|SUPERIORITY||Difference in proportion|-13.55||||0.19|TWO_SIDED|95.0|-33.65|6.55|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||6.55|-33.65|0.19
72361067|NCT03583099|144233342|SUPERIORITY||Difference in proportion|0.38||||0.95|TWO_SIDED|95.0|-12.5|13.27|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||13.27|-12.50|0.95
72361068|NCT03583099|144233343|SUPERIORITY||Difference in proportion|-6.97||||0.14|TWO_SIDED|95.0|-16.12|2.17|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||2.17|-16.12|0.14
72361069|NCT03583099|144233344|SUPERIORITY||Difference in proportion|-1.06||||0.87|TWO_SIDED|95.0|-13.39|11.27|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||11.27|-13.39|0.87
72361070|NCT03583099|144233345|SUPERIORITY||Difference in proportion|-1.8||||0.81|TWO_SIDED|95.0|-15.9|12.4|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||12.4|-15.9|0.81
72361071|NCT03583099|144233346|SUPERIORITY||Difference in proportion|2.3||||0.63|TWO_SIDED|95.0|-7.2|11.8|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||11.8|-7.2|0.63
72361072|NCT03583099|144233347|SUPERIORITY||Difference in proportion|5.8||||0.17|TWO_SIDED|95.0|-2.5|14.2|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||14.2|-2.5|0.17
72361073|NCT03583099|144233348|SUPERIORITY||Difference in proportion|-2.9||||0.58|TWO_SIDED|95.0|-13.0|7.3|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||7.3|-13.0|0.58
72361074|NCT03583099|144233349|SUPERIORITY||Difference in proportion|-0.6||||0.89|TWO_SIDED|95.0|-8.3|7.1|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||7.1|-8.3|0.89
72361075|NCT03583099|144233350|SUPERIORITY||Difference in proportion|-3.9||||0.16|TWO_SIDED|95.0|-9.2|1.5|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||1.5|-9.2|0.16
72361076|NCT03583099|144233351|SUPERIORITY||Difference in proportion|-2.2||||0.62|TWO_SIDED|95.0|-10.9|6.5|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||6.5|-10.9|0.62
72361077|NCT03583099|144233352|SUPERIORITY||Difference in proportion|-1.64||||0.84|TWO_SIDED|95.0|-17.27|13.99|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||13.99|-17.27|0.84
72361078|NCT03583099|144233353|SUPERIORITY||Difference in proportion|6.09||||0.27|TWO_SIDED|95.0|-4.63|16.8|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||16.80|-4.63|0.27
72361079|NCT03583099|144233354|SUPERIORITY||Difference in proportion|2.91||||0.55|TWO_SIDED|95.0|-6.59|12.41|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||12.41|-6.59|0.55
72361080|NCT03583099|144233355|SUPERIORITY||Difference in proportion|2.37||||0.69|TWO_SIDED|95.0|-9.09|13.83|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||13.83|-9.09|0.69
72361081|NCT03583099|144233356|SUPERIORITY||Difference in proportion|0.36||||0.93|TWO_SIDED|95.0|-8.13|8.85|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||8.85|-8.13|0.93
72361082|NCT03583099|144233357|SUPERIORITY||Difference in proportion|-4.01||||0.26|TWO_SIDED|95.0|-10.97|2.95|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||2.95|-10.97|0.26
72361083|NCT03583099|144233358|SUPERIORITY||Difference in proportion|-2.04||||0.74|TWO_SIDED|95.0|-14.28|10.21|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||10.21|-14.28|0.74
72361084|NCT03583099|144233359|SUPERIORITY||Difference in proportion|0.1||||0.98|TWO_SIDED|95.0|-7.9|8.1|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||8.1|-7.9|0.98
72361085|NCT03583099|144233360|SUPERIORITY||Difference in proportion|2.6||||0.46|TWO_SIDED|95.0|-4.3|9.6|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||9.6|-4.3|0.46
72361086|NCT03583099|144233361|SUPERIORITY||Difference in proportion|1.5||||0.5|TWO_SIDED|95.0|-3.0|6.1|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||6.1|-3.0|0.50
72361087|NCT03583099|144233362|SUPERIORITY||Difference in proportion|-0.2||||0.96|TWO_SIDED|95.0|-6.8|6.5|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||6.5|-6.8|0.96
72361088|NCT03583099|144233363|SUPERIORITY||Difference in proportion|2.2||||0.4|TWO_SIDED|95.0|-3.0|7.5|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||7.5|-3.0|0.40
72361089|NCT03583099|144233364|SUPERIORITY||Difference in proportion|-0.1||||0.96|TWO_SIDED|95.0|-4.3|4.0|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||4.0|-4.3|0.96
72361090|NCT03583099|144233365|SUPERIORITY||Difference in proportion|0.1||||0.98|TWO_SIDED|95.0|-7.9|8.1|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||8.1|-7.9|0.98
72361091|NCT03583099|144233366|SUPERIORITY||Difference in proportion|-4.2||||0.46|TWO_SIDED|95.0|-15.2|6.8|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||6.8|-15.2|0.46
72361092|NCT03583099|144233367|SUPERIORITY||Difference in proportion|3.9||||0.37|TWO_SIDED|95.0|-4.7|12.4|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||12.4|-4.7|0.37
72361093|NCT03583099|144233368|SUPERIORITY||Difference in proportion|-0.8||||0.75|TWO_SIDED|95.0|-6.0|4.4|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||4.4|-6.0|0.75
72361094|NCT03583099|144233369|SUPERIORITY||Difference in proportion|-8.7||||0.08|TWO_SIDED|95.0|-18.3|0.9|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||0.9|-18.3|0.08
72361095|NCT03583099|144233370|SUPERIORITY||Difference in proportion|-4.8||||0.11|TWO_SIDED|95.0|-10.6|1.1|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||1.1|-10.6|0.11
72361096|NCT03583099|144233371|SUPERIORITY||Difference in proportion|0.4||||0.89|TWO_SIDED|95.0|-5.1|5.9|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||5.9|-5.1|0.89
72361097|NCT03583099|144233372|SUPERIORITY||Difference in proportion|-8.8||||0.05|TWO_SIDED|95.0|-17.5|0.0|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||-0.0|-17.5|0.05
72361098|NCT03583099|144233373|SUPERIORITY||Difference in proportion|16.76||||0.09|TWO_SIDED|95.0|-2.89|36.42|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||36.42|-2.89|0.09
72361099|NCT03583099|144233374|SUPERIORITY||Difference in proportion|3.7||||0.56|TWO_SIDED|95.0|-8.6|15.9|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||15.9|-8.6|0.56
72361100|NCT03583099|144233375|SUPERIORITY||Difference in proportion|10.41||||0.49|TWO_SIDED|95.0|-19.39|40.2|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||40.20|-19.39|0.49
72361101|NCT03583099|144233376|SUPERIORITY||Difference in proportion|10.8||||0.06|TWO_SIDED|95.0|-0.5|22.1|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||22.1|-0.5|0.06
72361102|NCT03583099|144233377|SUPERIORITY||Difference in proportion|0.41||||0.94|TWO_SIDED|95.0|-10.97|11.79|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||11.79|-10.97|0.94
72361103|NCT03583099|144233378|SUPERIORITY||Difference in proportion|2.7||||0.57|TWO_SIDED|95.0|-6.5|11.8|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||11.8|-6.5|0.57
72361104|NCT03583099|144233379|SUPERIORITY||Difference in proportion|1.36||||0.89|TWO_SIDED|95.0|-18.01|20.73|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||20.73|-18.01|0.89
72361105|NCT03583099|144233380|SUPERIORITY||Difference in proportion|-2.2||||0.65|TWO_SIDED|95.0|-12.1|7.6|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||7.6|-12.1|0.65
72361106|NCT03583099|144233381|SUPERIORITY||Difference in proportion|12.48||||0.16|TWO_SIDED|95.0|-5.0|29.96|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||29.96|-5.00|0.16
72361107|NCT03583099|144233382|SUPERIORITY||Difference in proportion|4.3||||0.29|TWO_SIDED|95.0|-3.6|12.2|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||12.2|-3.6|0.29
72361108|NCT03583099|144233383|SUPERIORITY||Difference in proportion|5.28||||0.44|TWO_SIDED|95.0|-8.07|18.62|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||18.62|-8.07|0.44
72361109|NCT03583099|144233384|SUPERIORITY||Difference in proportion|-1.5||||0.62|TWO_SIDED|95.0|-7.6|4.5|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||4.5|-7.6|0.62
72361110|NCT03583099|144233385|SUPERIORITY||Difference in proportion|-7.1||||0.39|TWO_SIDED|95.0|-23.18|9.0|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||9.0|-23.18|0.39
72361111|NCT03583099|144233386|SUPERIORITY||Difference in proportion|-6.6||||0.08|TWO_SIDED|95.0|-13.9|0.8|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||0.8|-13.9|0.08
72361112|NCT03583099|144233387|SUPERIORITY||Difference in proportion|-11.3||||0.23|TWO_SIDED|95.0|-29.06|7.0|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||7.00|-29.06|0.23
72361113|NCT03583099|144233388|SUPERIORITY||Difference in means|-1.14||||0.97|TWO_SIDED|95.0|-6.42|4.13||The p-value adjusts for baseline CAT score.|Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||4.13|-6.42|0.97
72361114|NCT03583099|144233389|SUPERIORITY||Difference in means|-0.003||||0.47|TWO_SIDED|95.0|-1.86|1.85|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||1.85|-1.86|0.47
72361115|NCT03583099|144233390|SUPERIORITY||Difference in proportion|17.84||||0.02|TWO_SIDED|95.0|2.34|33.34|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||33.34|2.34|0.02
72429374|NCT04102540|144369726|OTHER|In this model, the null hypothesis was that the odds of good health at baseline/exposure 1 were exactly equal to the odds of good health at exposure 2 giving an odds ratio of one for the null hypothesis.|Odds Ratio (OR)|1.77||||0.316|TWO_SIDED|95.0|0.57|5.46||The p-value was not adjusted for multiple comparisons and the a priori threshold for significance was alpha = 0.05.|Regression, Logistic|This model included random effects for subjects.|This is the estimated odds ratio of having good health at exposure 2 relative to baseline/exposure 1.|"For analysis, we dichotomized participants' responses into the following categories: good vs bad health, where good included participant responses: excellent, very good, good, and bad included the participant responses: more or less and bad."||5.46|0.57|0.3160
72361116|NCT03583099|144233391|SUPERIORITY||Difference in proportion|7.8||||0.12|TWO_SIDED|95.0|-2.0|17.6|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||17.6|-2.0|0.12
72361117|NCT03583099|144233392|SUPERIORITY|||||||1|||||||Fisher Exact|The p-value is calculated from a two-sided Fisher's exact test. This test is appropriate since only one outcome per practice was seen.||||||1.0
72361118|NCT03583099|144233393|SUPERIORITY||Difference in proportion|2.06||||0.87|TWO_SIDED|95.0|-22.67|26.79|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||26.79|-22.67|0.87
72361119|NCT03583099|144233394|SUPERIORITY|||||||1|||||||Fisher Exact|The p-value is calculated from a two-sided Fisher's exact test.||||||1.0
72361120|NCT03583099|144233395|SUPERIORITY||Difference in proportion|-5.53||||0.56|TWO_SIDED|95.0|-24.33|13.28|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||13.28|-24.33|0.56
72361121|NCT03583099|144233396|SUPERIORITY|||||||1|||||||Fisher Exact|The p-value is calculated from a two-sided Fisher's exact test.||||||1.0
72361122|NCT03583099|144233397|SUPERIORITY||Difference in proportion|12.66||||0.21|TWO_SIDED|95.0|-7.05|32.37|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||32.37|-7.05|0.21
72361123|NCT03583099|144233398|SUPERIORITY|||||||1|||||||Fisher Exact|The p-value is calculated from a two-sided Fisher's exact test.||||||1.0
72361124|NCT03583099|144233399|SUPERIORITY||Difference in proportion|-18.29||||0.08|TWO_SIDED|95.0|-38.66|2.08|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||2.08|-38.66|0.08
72361125|NCT03583099|144233400|SUPERIORITY|||||||1|||||||Fisher Exact|The p-value is calculated from a two-sided Fisher's exact test.||||||1.0
72361126|NCT03583099|144233401|SUPERIORITY||Difference in proportion|-0.67||||0.92|TWO_SIDED|95.0|-14.06|12.71|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||12.71|-14.06|0.92
72361127|NCT03583099|144233403|SUPERIORITY||Difference in proportion|-5.47||||0.29|TWO_SIDED|95.0|-15.72|4.77|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||4.77|-15.72|0.29
72361128|NCT03583099|144233405|SUPERIORITY||Difference in proportion|-2.87||||0.69|TWO_SIDED|95.0|-17.14|11.39|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||11.39|-17.14|0.69
72361129|NCT03583099|144233406|SUPERIORITY||Difference in proportion|-13.15||||0.32|TWO_SIDED|95.0|-39.06|12.76|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||12.76|-39.06|0.32
72361130|NCT03583099|144233407|SUPERIORITY||Difference in proportion|-0.2||||0.98|TWO_SIDED|95.0|-15.5|15.0|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||15.0|-15.5|0.98
72361131|NCT03583099|144233409|SUPERIORITY||Difference in proportion|3.1||||0.55|TWO_SIDED|95.0|-7.0|13.1|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||13.1|-7.0|0.55
72361132|NCT03583099|144233410|SUPERIORITY||Difference in proportion|-8.61||||0.43|TWO_SIDED|95.0|-30.19|12.97|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||12.97|-30.19|0.43
72361133|NCT03583099|144233411|SUPERIORITY||Difference in proportion|7.6||||0.1|TWO_SIDED|95.0|-1.4|16.5|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||16.5|-1.4|0.10
72361134|NCT03583099|144233412|SUPERIORITY||Difference in proportion|0.82||||0.94|TWO_SIDED|95.0|-20.92|21.92|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||21.92|-20.92|0.94
72361135|NCT03583099|144233413|SUPERIORITY||Difference in proportion|-3.4||||0.55|TWO_SIDED|95.0|-14.4|7.6|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||7.6|-14.4|0.55
72361136|NCT03583099|144233415|SUPERIORITY||Difference in proportion|-1.1||||0.8|TWO_SIDED|95.0|-9.3|7.1|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||7.1|-9.3|0.80
72361137|NCT03583099|144233417|SUPERIORITY||Difference in proportion|-3.9||||0.18|TWO_SIDED|95.0|-9.7|1.8|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||1.8|-9.7|0.18
72361138|NCT03583099|144233418|SUPERIORITY||Difference in proportion|-0.17||||0.99|TWO_SIDED|95.0|-26.06|25.72|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||25.72|-26.06|0.99
72361139|NCT03583099|144233419|SUPERIORITY||Difference in proportion|-2.6||||0.59|TWO_SIDED|95.0|-12.0|6.8|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||6.8|-12.0|0.59
72361140|NCT03583099|144233421|SUPERIORITY||Difference in proportion|1.9||||0.82|TWO_SIDED|95.0|-14.5|18.4|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||18.4|-14.5|0.82
72361141|NCT03583099|144233423|SUPERIORITY||Difference in proportion|7.6||||0.2|TWO_SIDED|95.0|-4.1|19.3|||Wilcoxon (Mann-Whitney)||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||19.3|-4.1|0.20
72361142|NCT03583099|144233425|SUPERIORITY||Difference in proportion|4.9||||0.36|TWO_SIDED|95.0|-5.5|15.3|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||15.3|-5.5|0.36
72361143|NCT03583099|144233427|SUPERIORITY||Difference in proportion|4.6||||0.47|TWO_SIDED|95.0|-7.9|17.1|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||17.1|-7.9|0.47
72361144|NCT03583099|144233429|SUPERIORITY||Difference in proportion|0.6||||0.88|TWO_SIDED|95.0|-7.8|9.0|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||9.0|-7.8|0.88
72361145|NCT03583099|144233431|SUPERIORITY||Difference in proportion|-4.3||||0.27|TWO_SIDED|95.0|-12.0|3.4|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||3.4|-12.0|0.27
72361146|NCT03583099|144233432|SUPERIORITY||Difference in proportion|-4.94||||0.82|TWO_SIDED|95.0|-47.92|38.04|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||38.04|-47.92|0.82
72361147|NCT03583099|144233433|SUPERIORITY||Difference in proportion|-1.1||||0.87|TWO_SIDED|95.0|-14.5|12.2|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||12.2|-14.5|0.87
72361148|NCT03583099|144233434|SUPERIORITY||Difference in proportion|-37.6||||0.03|TWO_SIDED|95.0|-71.8|-3.5|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||-3.5|-71.8|0.03
72361149|NCT03583099|144233435|SUPERIORITY||Difference in proportion|2.3||||0.56|TWO_SIDED|95.0|-5.6|10.3|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||10.3|-5.6|0.56
72361150|NCT03583099|144233436|SUPERIORITY||Difference in proportion|-23.07||||0.06|TWO_SIDED|95.0|-47.4|1.27|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||1.27|-47.40|0.06
72361151|NCT03583099|144233437|SUPERIORITY||Difference in proportion|3.2||||0.39|TWO_SIDED|95.0|-4.0|10.4|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||10.4|-4.0|0.39
72361152|NCT03583099|144233438|SUPERIORITY||Difference in proportion|-1.72||||0.84|TWO_SIDED|95.0|-18.24|14.8|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||14.80|-18.24|0.84
72361153|NCT03583099|144233439|SUPERIORITY||Difference in proportion|2.0||||0.42|TWO_SIDED|95.0|-2.9|6.9|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||6.9|-2.9|0.42
72361154|NCT03583099|144233440|SUPERIORITY||Difference in proportion|-42.09||||0.01|TWO_SIDED|95.0|-74.27|-9.92|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||-9.92|-74.27|0.01
72361155|NCT03583099|144233441|SUPERIORITY||Difference in proportion|2.4||||0.47|TWO_SIDED|95.0|-4.2|9.1|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||9.1|-4.2|0.47
72361156|NCT03583099|144233442|SUPERIORITY||Difference in proportion|-12.27||||0.34|TWO_SIDED|95.0|-37.72|13.18|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||13.18|-37.72|0.34
72361157|NCT03583099|144233443|SUPERIORITY||Difference in proportion|2.4||||0.39|TWO_SIDED|95.0|-3.1|7.9|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||7.9|-3.1|0.39
72361158|NCT03583099|144233445|SUPERIORITY||Difference in proportion|-1.2||||0.59|TWO_SIDED|95.0|-5.5|3.1|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||3.1|-5.5|0.59
72361159|NCT03583099|144233447|SUPERIORITY||Difference in proportion|0.3||||0.94|TWO_SIDED|95.0|-8.2|8.8|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||8.8|-8.2|0.94
72361160|NCT03583099|144233448|SUPERIORITY||Difference in proportion|0.6||||0.93|TWO_SIDED|95.0|-12.2|13.4|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||13.4|-12.2|0.93
72361161|NCT03583099|144233449|SUPERIORITY||Difference in proportion|-8.2||||0.25|TWO_SIDED|95.0|-22.0|5.7|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||5.7|-22.0|0.25
72361162|NCT03583099|144233450|SUPERIORITY||Difference in proportion|-3.4||||0.48|TWO_SIDED|95.0|-12.7|6.0|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||6.0|-12.7|0.48
72361163|NCT03583099|144233451|SUPERIORITY||Difference in proportion|3.9||||0.45|TWO_SIDED|95.0|-6.3|14.2|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||14.2|-6.3|0.45
72361164|NCT03583099|144233453|SUPERIORITY||Difference in proportion|-2.2||||0.48|TWO_SIDED|95.0|-8.4|3.9|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||3.9|-8.4|0.48
72361165|NCT03583099|144233454|SUPERIORITY||Difference in proportion|-0.4||||0.97|TWO_SIDED|95.0|-20.4|19.5|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||19.5|-20.4|0.97
72361166|NCT03583099|144233455|SUPERIORITY||Difference in proportion|-12.1||||0.04|TWO_SIDED|95.0|-23.5|-0.6|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||-0.6|-23.5|0.04
72361167|NCT03583099|144233456|SUPERIORITY||Difference in proportion|-1.8||||0.39|TWO_SIDED|95.0|-5.8|2.3|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||2.3|-5.8|0.39
72361168|NCT03583099|144233457|SUPERIORITY||Difference in proportion|-7.3||||0.06|TWO_SIDED|95.0|-14.9|0.4|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||0.4|-14.9|0.06
72361169|NCT03583099|144233458|SUPERIORITY||Difference in proportion|-0.9||||0.82|TWO_SIDED|95.0|-8.8|7.0|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||7.0|-8.8|0.82
72361170|NCT03583099|144233459|SUPERIORITY||Difference in proportion|0.6||||0.86|TWO_SIDED|95.0|-6.6|7.9|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||7.9|-6.6|0.86
72361171|NCT03583099|144233460|SUPERIORITY||Difference in proportion|-7.4||||0.14|TWO_SIDED|95.0|-17.3|2.5|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||2.5|-17.3|0.14
72361172|NCT03583099|144233462|SUPERIORITY||Difference in proportion|-14.66||||0.21|TWO_SIDED|95.0|-37.54|8.22|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||8.22|-37.54|0.21
72361173|NCT03583099|144233463|SUPERIORITY||Difference in proportion|0.4||||0.76|TWO_SIDED|95.0|-2.0|2.7|||Generalized estimating equation contrast|||||2.7|-2.0|0.76
72361174|NCT03583099|144233466|SUPERIORITY||Difference in proportion|0.6||||0.66|TWO_SIDED|95.0|-2.1|3.4|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||3.4|-2.1|0.66
72361175|NCT05543265|144233476|SUPERIORITY||Mean Difference (Final Values)|22.0|||<|0.001|TWO_SIDED|95.0|6.4|28.8|||Chi-squared|||||28.8|6.4|<0.001
72361176|NCT05316597|144233504|SUPERIORITY||Mean Difference (Final Values)|0.01||||0.914|TWO_SIDED|||||a priori threshold for statistical significance = p \< 0.05.|Mixed Models Analysis|Control for that session's baseline included in the mixed model.||||||0.914
72361177|NCT05316597|144233505|SUPERIORITY||Mean Difference (Final Values)|1.13||||0.554|TWO_SIDED|||||a priori threshold for statistical significance = p \< 0.05.|Mixed Models Analysis|Control for that session's baseline included in the mixed model.||||||.554
72361178|NCT05316597|144233506|SUPERIORITY||Mean Difference (Final Values)|0.13||||0.905|TWO_SIDED|||||a priori threshold for statistical significance = p \< 0.05.|Mixed Models Analysis|||||||0.905
72361179|NCT05316597|144233507|SUPERIORITY||Mean Difference (Final Values)|-0.84||||0.076|TWO_SIDED|||||a priori threshold for statistical significance = p \< 0.05.|Mixed Models Analysis|Control for that session's baseline included in the mixed model.||||||0.076
72361180|NCT05316597|144233507|SUPERIORITY|||||||0.02||||||Threshold of P \< 0.05 for significance. ANCOVA results of comparing reduced vs. full model over time.|ANOVA|||Exploratory ANOVA results comparing full and reduced models to test the effect of terpene exposure on pattern of outcome over time.||||0.02
72361181|NCT05316597|144233508|SUPERIORITY||Mean Difference (Final Values)|0.7||||0.21|TWO_SIDED|||||a priori threshold for statistical significance = p \< 0.05.|Mixed Models Analysis|Control for that session's baseline included in the mixed model.||||||0.210
72361182|NCT05316597|144233508|SUPERIORITY|||||||0.57||||||Threshold of P \< 0.05 for significance. ANCOVA results of comparing reduced vs. full model over time.|ANOVA|||Exploratory ANOVA results comparing full and reduced models to test the effect of terpene exposure on pattern of outcome over time.||||0.57
72361183|NCT05316597|144233509|SUPERIORITY||Mean Difference (Final Values)|0.01||||0.921|TWO_SIDED|||||a priori threshold for statistical significance = p \< 0.05.|Mixed Models Analysis|Control for that session's baseline included in the mixed model.||||||0.921
72361184|NCT05316597|144233509|SUPERIORITY|||||||0.82||||||Threshold of P \< 0.05 for significance. ANCOVA results of comparing reduced vs. full model over time.|ANOVA|||||||0.82
72361185|NCT05316597|144233510|SUPERIORITY||Mean Difference (Final Values)|-0.16||||0.265|TWO_SIDED|||||a priori threshold for statistical significance = p \< 0.05.|Mixed Models Analysis|Control for that session's baseline included in the mixed model.||||||0.265
72361186|NCT05316597|144233510|SUPERIORITY|||||||0.63||||||Threshold of P \< 0.05 for significance. ANCOVA results of comparing reduced vs. full model over time.|ANOVA|||||||0.63
72361187|NCT05316597|144233511|SUPERIORITY||Median Difference (Final Values)|-0.34||||0.724|TWO_SIDED|||||a priori threshold for statistical significance = p \< 0.05.|Mixed Models Analysis|Control for that session's baseline included in the mixed model.||||||0.724
72361188|NCT05316597|144233512|SUPERIORITY||Mean Difference (Final Values)|-2.85||||0.716|TWO_SIDED|||||a priori threshold for statistical significance = p \< 0.05.|Mixed Models Analysis|Control for that session's baseline included in the mixed model.||||||0.716
72361189|NCT05316597|144233513|SUPERIORITY||Mean Difference (Final Values)|-0.53||||0.852|TWO_SIDED|||||a priori threshold for statistical significance = p \< 0.05.|Mixed Models Analysis|Control for that session's baseline included in the mixed model.||||||0.852
72361190|NCT05316597|144233514|SUPERIORITY||Mean Difference (Final Values)|-0.79||||0.166|TWO_SIDED|||||a priori threshold for statistical significance = p \< 0.05.|Mixed Models Analysis|Control for that session's baseline included in the mixed model.||||||0.166
72361191|NCT05316597|144233515|SUPERIORITY||Mean Difference (Final Values)|-0.19||||0.046|TWO_SIDED|||||a priori threshold for statistical significance = p \< 0.05.|Mixed Models Analysis|Control for that session's baseline included in the mixed model.||||||0.046
72361192|NCT05526716|144233532|NON_INFERIORITY|Serotype 3|Geometric Mean Titers Ratio (GMT Ratio)|0.84|||||TWO_SIDED|95.0|0.72|0.97||||||The concomitant group will be considered noninferior to the sequential group if the lower bound of the 2-sided 95% CI of the OPA GMT ratio (GMTcon/GMTseq) for each of the serotypes is \>0.50.||0.97|0.72|
72361193|NCT05526716|144233532|NON_INFERIORITY|Serotype 6A|GMT Ratio|0.79|||||TWO_SIDED|95.0|0.66|0.94||||||The concomitant group will be considered noninferior to the sequential group if the lower bound of the 2-sided 95% CI of the OPA GMT ratio (GMTcon/GMTseq) for each of the serotypes is \>0.50.||0.94|0.66|
72361194|NCT05526716|144233532|NON_INFERIORITY|Serotype 7F|GMT Ratio|0.73|||||TWO_SIDED|95.0|0.63|0.85||||||The concomitant group will be considered noninferior to the sequential group if the lower bound of the 2-sided 95% CI of the OPA GMT ratio (GMTcon/GMTseq) for each of the serotypes is \>0.50.||0.85|0.63|
72361195|NCT05526716|144233532|NON_INFERIORITY|Serotype 8|GMT Ratio|0.71|||||TWO_SIDED|95.0|0.61|0.82||||||The concomitant group will be considered noninferior to the sequential group if the lower bound of the 2-sided 95% CI of the OPA GMT ratio (GMTcon/GMTseq) for each of the serotypes is \>0.50.||0.82|0.61|
72361196|NCT05526716|144233532|NON_INFERIORITY|Serotype 9N|GMT Ratio|0.67|||||TWO_SIDED|95.0|0.57|0.79||||||The concomitant group will be considered noninferior to the sequential group if the lower bound of the 2-sided 95% CI of the OPA GMT ratio (GMTcon/GMTseq) for each of the serotypes is \>0.50.||0.79|0.57|
72361197|NCT05526716|144233532|NON_INFERIORITY|Serotype 10A|GMT Ratio|0.76|||||TWO_SIDED|95.0|0.65|0.91||||||The concomitant group will be considered noninferior to the sequential group if the lower bound of the 2-sided 95% CI of the OPA GMT ratio (GMTcon/GMTseq) for each of the serotypes is \>0.50.||0.91|0.65|
72361198|NCT05526716|144233532|NON_INFERIORITY|Serotype 11A|GMT Ratio|0.64|||||TWO_SIDED|95.0|0.54|0.75||||||The concomitant group will be considered noninferior to the sequential group if the lower bound of the 2-sided 95% CI of the OPA GMT ratio (GMTcon/GMTseq) for each of the serotypes is \>0.50.||0.75|0.54|
72361199|NCT05526716|144233532|NON_INFERIORITY|Serotype 12F|GMT Ratio|0.76|||||TWO_SIDED|95.0|0.62|0.94||||||The concomitant group will be considered noninferior to the sequential group if the lower bound of the 2-sided 95% CI of the OPA GMT ratio (GMTcon/GMTseq) for each of the serotypes is \>0.50.||0.94|0.62|
72361200|NCT05526716|144233532|NON_INFERIORITY|Serotype 15A|GMT Ratio|0.71|||||TWO_SIDED|95.0|0.6|0.85||||||The concomitant group will be considered noninferior to the sequential group if the lower bound of the 2-sided 95% CI of the OPA GMT ratio (GMTcon/GMTseq) for each of the serotypes is \>0.50.||0.85|0.60|
72361201|NCT05526716|144233532|NON_INFERIORITY|Serotype 15C|GMT Ratio|0.71|||||TWO_SIDED|95.0|0.58|0.87||||||The concomitant group will be considered noninferior to the sequential group if the lower bound of the 2-sided 95% CI of the OPA GMT ratio (GMTcon/GMTseq) for each of the serotypes is \>0.50.||0.87|0.58|
72361202|NCT05526716|144233532|NON_INFERIORITY|Serotype 16F|GMT Ratio|0.69|||||TWO_SIDED|95.0|0.59|0.81||||||The concomitant group will be considered noninferior to the sequential group if the lower bound of the 2-sided 95% CI of the OPA GMT ratio (GMTcon/GMTseq) for each of the serotypes is \>0.50.||0.81|0.59|
72361203|NCT05526716|144233532|NON_INFERIORITY|Serotype 17F|GMT Ratio|0.73|||||TWO_SIDED|95.0|0.62|0.86||||||The concomitant group will be considered noninferior to the sequential group if the lower bound of the 2-sided 95% CI of the OPA GMT ratio (GMTcon/GMTseq) for each of the serotypes is \>0.50.||0.86|0.62|
72361204|NCT05526716|144233532|NON_INFERIORITY|Serotype 19A|GMT Ratio|0.75|||||TWO_SIDED|95.0|0.65|0.85||||||The concomitant group will be considered noninferior to the sequential group if the lower bound of the 2-sided 95% CI of the OPA GMT ratio (GMTcon/GMTseq) for each of the serotypes is \>0.50.||0.85|0.65|
72361205|NCT05526716|144233532|NON_INFERIORITY|Serotype 20A|GMT Ratio|0.74|||||TWO_SIDED|95.0|0.63|0.87||||||The concomitant group will be considered noninferior to the sequential group if the lower bound of the 2-sided 95% CI of the OPA GMT ratio (GMTcon/GMTseq) for each of the serotypes is \>0.50.||0.87|0.63|
72361206|NCT05526716|144233532|NON_INFERIORITY|Serotype 22F|GMT Ratio|0.77|||||TWO_SIDED|95.0|0.65|0.91||||||The concomitant group will be considered noninferior to the sequential group if the lower bound of the 2-sided 95% CI of the OPA GMT ratio (GMTcon/GMTseq) for each of the serotypes is \>0.50.||0.91|0.65|
72361207|NCT05526716|144233532|NON_INFERIORITY|Serotype 23A|GMT Ratio|0.78|||||TWO_SIDED|95.0|0.63|0.96||||||The concomitant group will be considered noninferior to the sequential group if the lower bound of the 2-sided 95% CI of the OPA GMT ratio (GMTcon/GMTseq) for each of the serotypes is \>0.50.||0.96|0.63|
72361208|NCT05526716|144233532|NON_INFERIORITY|Serotype 23B|GMT Ratio|0.56|||||TWO_SIDED|95.0|0.44|0.72||||||The concomitant group will be considered noninferior to the sequential group if the lower bound of the 2-sided 95% CI of the OPA GMT ratio (GMTcon/GMTseq) for each of the serotypes is \>0.50.||0.72|0.44|
72361209|NCT05526716|144233532|NON_INFERIORITY|Serotype 24F|GMT Ratio|0.72|||||TWO_SIDED|95.0|0.61|0.86||||||The concomitant group will be considered noninferior to the sequential group if the lower bound of the 2-sided 95% CI of the OPA GMT ratio (GMTcon/GMTseq) for each of the serotypes is \>0.50.||0.86|0.61|
72361210|NCT05526716|144233532|NON_INFERIORITY|Serotype 31|GMT Ratio|0.68|||||TWO_SIDED|95.0|0.56|0.83||||||The concomitant group will be considered noninferior to the sequential group if the lower bound of the 2-sided 95% CI of the OPA GMT ratio (GMTcon/GMTseq) for each of the serotypes is \>0.50.||0.83|0.56|
72361211|NCT05526716|144233532|NON_INFERIORITY|Serotype 33F|GMT Ratio|0.84|||||TWO_SIDED|95.0|0.7|1.01||||||The concomitant group will be considered noninferior to the sequential group if the lower bound of the 2-sided 95% CI of the OPA GMT ratio (GMTcon/GMTseq) for each of the serotypes is \>0.50.||1.01|0.70|
72361212|NCT05526716|144233532|NON_INFERIORITY|Serotype 35B|GMT Ratio|0.77|||||TWO_SIDED|95.0|0.67|0.89||||||The concomitant group will be considered noninferior to the sequential group if the lower bound of the 2-sided 95% CI of the OPA GMT ratio (GMTcon/GMTseq) for each of serotypes is \>0.50.||0.89|0.67|
72361213|NCT05526716|144233533|NON_INFERIORITY|A/H1N1|GMT Ratio|0.83|||||TWO_SIDED|95.0|0.7|0.97||||||The concomitant group will be considered noninferior to the sequential group if the lower bound of the 2-sided 95% CI of the HAI GMT ratio (GMTcon/GMTseq) for each of the strains is \>0.67.||0.97|0.70|
72361214|NCT05526716|144233533|NON_INFERIORITY|A/H3N2|GMT Ratio|0.79|||||TWO_SIDED|95.0|0.67|0.93||||||The concomitant group will be considered noninferior to the sequential group if the lower bound of the 2-sided 95% CI of the HAI GMT ratio (GMTcon/GMTseq) for each of the strains is \>0.67.||0.93|0.67|
72361215|NCT05526716|144233533|NON_INFERIORITY|B/Victoria|GMT Ratio|0.82|||||TWO_SIDED|95.0|0.7|0.95||||||The concomitant group will be considered noninferior to the sequential group if the lower bound of the 2-sided 95% CI of the HAI GMT ratio (GMTcon/GMTseq) for each of the strains is \>0.67.||0.95|0.70|
72361216|NCT05526716|144233533|NON_INFERIORITY|B/Yamagata|GMT Ratio|0.89|||||TWO_SIDED|95.0|0.78|1.0||||||The concomitant group will be considered noninferior to the sequential group if the lower bound of the 2-sided 95% CI of the HAI GMT ratio (GMTcon/GMTseq) for each of the strains is \>0.67.||1.00|0.78|
72361217|NCT05526716|144233534|OTHER|Serotype 3|GMC Ratio|0.9|||||TWO_SIDED|95.0|0.8|1.02||||||||1.02|0.80|
72361218|NCT05526716|144233534|OTHER|Serotype 6A|GMC Ratio|0.93|||||TWO_SIDED|95.0|0.79|1.11||||||||1.11|0.79|
72361219|NCT05526716|144233534|OTHER|Serotype 7F|GMC Ratio|0.78|||||TWO_SIDED|95.0|0.67|0.9||||||||0.90|0.67|
72361220|NCT05526716|144233534|OTHER|Serotype 8|GMC Ratio|0.82|||||TWO_SIDED|95.0|0.7|0.95||||||||0.95|0.70|
72361221|NCT05526716|144233534|OTHER|Serotype 9N|GMC Ratio|0.88|||||TWO_SIDED|95.0|0.75|1.05||||||||1.05|0.75|
72361222|NCT05526716|144233534|OTHER|Serotype 10A|GMC Ratio|0.79|||||TWO_SIDED|95.0|0.67|0.94||||||||0.94|0.67|
72361223|NCT05526716|144233534|OTHER|Serotype 11A|GMC Ratio|0.83|||||TWO_SIDED|95.0|0.72|0.96||||||||0.96|0.72|
72361224|NCT05526716|144233534|OTHER|Serotype 12F|GMC Ratio|0.83|||||TWO_SIDED|95.0|0.69|1.01||||||||1.01|0.69|
72361225|NCT05526716|144233534|OTHER|Serotype 15A|GMC Ratio|0.75|||||TWO_SIDED|95.0|0.63|0.9||||||||0.90|0.63|
72361226|NCT05526716|144233534|OTHER|Serotype 15C|GMC Ratio|0.85|||||TWO_SIDED|95.0|0.71|1.02||||||||1.02|0.71|
72361227|NCT05526716|144233534|OTHER|Serotype 16F|GMC Ratio|0.83|||||TWO_SIDED|95.0|0.7|0.99||||||||0.99|0.70|
72361228|NCT05526716|144233534|OTHER|Serotype 17F|GMC Ratio|0.85|||||TWO_SIDED|95.0|0.72|0.99||||||||0.99|0.72|
72361229|NCT05526716|144233534|OTHER|Serotype 19A|GMC Ratio|0.81|||||TWO_SIDED|95.0|0.71|0.93||||||||0.93|0.71|
72361230|NCT05526716|144233534|OTHER|Serotype 20A|GMC Ratio|0.82|||||TWO_SIDED|95.0|0.7|0.97||||||||0.97|0.70|
72361231|NCT05526716|144233534|OTHER|Serotype 22F|GMC Ratio|0.94|||||TWO_SIDED|95.0|0.8|1.1||||||||1.10|0.80|
72361232|NCT05526716|144233534|OTHER|Serotype 23A|GMC Ratio|0.85|||||TWO_SIDED|95.0|0.7|1.03||||||||1.03|0.70|
72361233|NCT05526716|144233534|OTHER|Serotype 23B|GMC Ratio|0.86|||||TWO_SIDED|95.0|0.72|1.02||||||||1.02|0.72|
72361234|NCT05526716|144233534|OTHER|Serotype 24F|GMC Ratio|0.85|||||TWO_SIDED|95.0|0.69|1.05||||||||1.05|0.69|
72361235|NCT05526716|144233534|OTHER|Serotype 31|GMC Ratio|0.84|||||TWO_SIDED|95.0|0.72|0.99||||||||0.99|0.72|
72361236|NCT05526716|144233534|OTHER|Serotype 33F|GMC Ratio|0.81|||||TWO_SIDED|95.0|0.69|0.94||||||||0.94|0.69|
72361237|NCT05526716|144233534|OTHER|Serotype 35B|GMC Ratio|0.85|||||TWO_SIDED|95.0|0.72|0.99||||||||0.99|0.72|
72361238|NCT00807911|144233548|OTHER||Hazard Ratio (HR)|0.657||||0.047|TWO_SIDED|95.0|0.434|0.994|||t-test, 1 sided|||||0.994|0.434|0.047
72361239|NCT00807911|144233549|OTHER||Hazard Ratio (HR)|0.602||||0.04|TWO_SIDED|95.0|0.371|0.977|||t-test, 1 sided|||||0.977|0.371|0.040
72361240|NCT00807911|144233550|OTHER||Hazard Ratio (HR)|0.744||||0.47|TWO_SIDED|95.0|0.334|1.657|||t-test, 1 sided|||||1.657|0.334|0.47
72361241|NCT00807911|144233551|OTHER||Hazard Ratio (HR)|0.456||||0.036|TWO_SIDED|95.0|0.215|0.97|||t-test, 1 sided|||||0.970|0.215|0.036
72361242|NCT03164668|144233610|SUPERIORITY||Estimated mean ratio|0.31|||||TWO_SIDED|95.0|0.13|0.72|||||Baseline adjusted model estimated mean ratio in cigarettes smoked per day of those randomized conditions in which menthol cigarettes are avoided relative to conditions in which participants can continue smoking usual cigarettes|Comparison of those assigned to conditions in which menthol cigarettes are avoided relative to conditions in which can continue smoking usual cigarettes||0.72|0.13|
72361243|NCT03164668|144233610|SUPERIORITY||Estimated mean ratio|0.98|||||TWO_SIDED|95.0|0.78|1.22|||||Baseline adjusted model estimated mean ratio in cigarettes smoked per day among those in conditions in which they receive tobacco flavored e-cigarettes relative to conditions in which they receive menthol flavored e-cigarettes|Comparison of those assigned to conditions in which they receive tobacco flavored e-cigarettes relative to conditions in which they receive menthol flavored e-cigarettes||1.22|0.78|
72361244|NCT03164668|144233611|SUPERIORITY||Estimated mean ratio|3.03|||||TWO_SIDED|95.0|1.39|6.61|||||Model estimated mean ratio in puffs of e-cigarettes used per day among those randomized to conditions in which menthol cigarettes are avoided relative to conditions in which participants can continue smoking usual cigarettes|Comparison of those assigned to conditions in which menthol cigarettes are avoided relative to conditions in which can continue smoking usual cigarettes||6.61|1.39|
72361245|NCT03164668|144233611|SUPERIORITY||Estimated mean ratio|0.74|||||TWO_SIDED|95.0|0.59|0.92|||||Estimated mean ratio of number of puffs of e-cigarettes used per day among those in conditions in which they receive tobacco flavored e-cigarettes relative to conditions in which they receive menthol flavored e-cigarettes|Comparison of those assigned to conditions in which they receive tobacco flavored e-cigarettes relative to conditions in which they receive menthol flavored e-cigarettes||0.92|0.59|
72361246|NCT04739982|144233617|SUPERIORITY||Cohen's D|0.03|STANDARD_ERROR_OF_MEAN|1.36||0.41|TWO_SIDED|95.0|-0.21|0.27||An independent samples t-test was conducted to compare the change in baseline and follow-up scores of treatment and treatment as usual participants.|t-test, 1 sided|Degrees of freedom=274 Significance level=.05||||.27|-.21|.41
72361247|NCT04739982|144233618|SUPERIORITY||Cohen's D|0.153|STANDARD_ERROR_OF_MEAN|1.45||0.095|TWO_SIDED|95.0|-0.08|0.39|||t-test, 1 sided|||||.39|-.08|.095
72361248|NCT04739982|144233620|SUPERIORITY||Cohen's D|0.19|STANDARD_ERROR_OF_MEAN|0.55||0.09|TWO_SIDED|95.0|-0.09|0.47|||t-test, 1 sided|||||.47|-.09|.09
72361249|NCT02960217|144233706|SUPERIORITY||Hodges-Lehmann estimate (Median Diff.)|1.46||||0.2684|TWO_SIDED|95.0|-1.12|4.36||Hodges-Lehmann estimate of the location shift with 95% confidence interval (CI) and Wilcoxon Rank Sum test p-value are based on Wilcoxon rank-sum test.|Wilcoxon Rank Sum test|||Participants completing both UX007 treatment period and placebo period (n=42). Per protocol, when the normality assumption is not met (p value for Wilk-Shapiro test \< 0.05), Wilcoxon rank-sum test will be considered as the primary analysis to assess treatment difference in movement disorder event frequency.||4.36|-1.12|0.2684
72361250|NCT02960217|144233706|SUPERIORITY||||||<|0.0001|||||||Wilk-Shapiro test for normality|||||||< 0.0001
72361251|NCT02960217|144233709|SUPERIORITY||Hodges-Lehmann estimate (Median Diff.)|25.0||||0.6419|TWO_SIDED|95.0|-62.5|91.5||Hodges-Lehmann estimate of the location shift with 95% CI and Wilcoxon Rank Sum test p-value are based on Wilcoxon rank-sum test.|Wilcoxon Rank Sum test|||Number of participants in this analysis completed both UX007 treatment period and placebo treatment period (n=34).||91.5|-62.5|0.6419
72361252|NCT02960217|144233709|SUPERIORITY|||||||0.0005|||||||Wilk-Shapiro Test for Normality|||||||0.0005
72361253|NCT02960217|144233710|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.91||0.9513|TWO_SIDED|95.0|-2.0|1.9||Based on an ANCOVA model including covariate for period baseline value, fixed effects for treatment sequence, treatment group, period, and a random effect for participant within the sequence.|ANCOVA|||||1.9|-2.0|0.9513
72361254|NCT02960217|144233710|SUPERIORITY|||||||0.8214|||||||Wilk-Shapiro Test for Normality|||||||0.8214
72361255|NCT02960217|144233711|SUPERIORITY||LS Mean Difference|2.0|STANDARD_ERROR_OF_MEAN|1.32||0.1572|TWO_SIDED|95.0|-0.8|4.7||Based on an ANCOVA model including covariate for period baseline value, fixed effects for treatment sequence, treatment group, period, and a random effect for participant within the sequence.|ANCOVA|||||4.7|-0.8|0.1572
72361256|NCT02960217|144233711|SUPERIORITY|||||||0.8451|||||||Wilk-Shapiro Test for Normality|||||||0.8451
72361257|NCT02960217|144233712|SUPERIORITY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|1.66||0.8345|TWO_SIDED|95.0|-3.8|3.1||Based on an ANCOVA model including covariate for period baseline value, fixed effects for treatment sequence, treatment group, period, and a random effect for participant within the sequence.|ANCOVA|||||3.1|-3.8|0.8345
72361258|NCT02960217|144233712|SUPERIORITY|||||||0.2894|||||||Wilk-Shapiro Test for Normality|||||||0.2894
72361259|NCT02960217|144233713|SUPERIORITY|||||||0.0005|||||||Wilk-Shapiro Test for Normality|||||||0.0005
72361260|NCT02960217|144233713|SUPERIORITY||Hodges-Lehmann estimate (Median Diff.)|0.2||||0.4898|TWO_SIDED|95.0|-5.4|5.8||Hodges-Lehmann estimate of the location shift with 95% CI and Wilcoxon Rank Sum test p-value are based on Wilcoxon rank-sum test.|Wilcoxon Rank Sum test|||Number of participants in this analysis completed both UX007 treatment period and placebo treatment period (n=21).||5.8|-5.4|0.4898
72361261|NCT02960217|144233714|SUPERIORITY||LS Mean Difference|0.8|STANDARD_ERROR_OF_MEAN|1.42||0.5853|TWO_SIDED|95.0|-2.2|3.8||Based on an ANCOVA model including covariate for period baseline value, fixed effects for treatment sequence, treatment group, period, and a random effect for participant within the sequence.|ANCOVA|||||3.8|-2.2|0.5853
72361262|NCT02960217|144233714|SUPERIORITY|||||||0.1066|||||||Wilk-Shapiro Test for Normality|||||||0.1066
72361263|NCT02960217|144233715|SUPERIORITY||LS Mean Difference|-1.8|STANDARD_ERROR_OF_MEAN|1.33||0.1875|TWO_SIDED|95.0|-4.6|1.0||Based on an ANCOVA model including covariate for period baseline value, fixed effects for treatment sequence, treatment group, period, and a random effect for participant within the sequence.|ANCOVA|||||1.0|-4.6|0.1875
72361264|NCT02960217|144233715|SUPERIORITY|||||||0.2034|||||||Wilk-Shapiro Test for Normality|||||||0.2034
72361265|NCT02960217|144233716|SUPERIORITY||LS Mean Difference|2.6|STANDARD_ERROR_OF_MEAN|1.56||0.1138|TWO_SIDED|95.0|-0.7|5.9||Based on an ANCOVA model including covariate for period baseline value, fixed effects for treatment sequence, treatment group, period, and a random effect for participant within the sequence.|ANCOVA|||||5.9|-0.7|0.1138
72361266|NCT02960217|144233716|SUPERIORITY|||||||0.1478|||||||Wilk-Shapiro Test for Normality|||||||0.1478
72361267|NCT02960217|144233717|SUPERIORITY||LS Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|1.62||0.5505|TWO_SIDED|95.0|-4.6|2.6||Based on an ANCOVA model including covariate for period baseline value, fixed effects for treatment sequence, treatment group, period, and a random effect for participant within the sequence.|ANCOVA|||||2.6|-4.6|0.5505
72361268|NCT02960217|144233717|SUPERIORITY|||||||0.4459|||||||Wilk-Shapiro Test for Normality|||||||0.4459
72361269|NCT02960217|144233718|SUPERIORITY||LS Mean Difference|-1.7|STANDARD_ERROR_OF_MEAN|2.84||0.5544|TWO_SIDED|95.0|-8.1|4.6||Based on an ANCOVA model including covariate for period baseline value, fixed effects for treatment sequence, treatment group, period, and a random effect for participant within the sequence.|ANCOVA|||||4.6|-8.1|0.5544
72361270|NCT02960217|144233718|SUPERIORITY|||||||0.1104|||||||Wilk-Shapiro Test for Normality|||||||0.1104
72361271|NCT02960217|144233719|SUPERIORITY||LS Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|3.27||0.7145|TWO_SIDED|95.0|-8.5|6.1|||ANCOVA|||||6.1|-8.5|0.7145
72361272|NCT02960217|144233719|SUPERIORITY|||||||0.8255|||||||Wilk-Shapiro Test for Normality|||||||0.8255
72361273|NCT02960217|144233720|SUPERIORITY||LS Mean Difference|1.5|STANDARD_ERROR_OF_MEAN|1.82||0.4176|TWO_SIDED|95.0|-2.5|5.6||Based on an ANCOVA model including covariate for period baseline value, fixed effects for treatment sequence, treatment group, period, and a random effect for participant within the sequence.|ANCOVA|||||5.6|-2.5|0.4176
72361274|NCT02960217|144233720|SUPERIORITY|||||||0.6557|||||||Wilk-Shapiro Test for Normality|||||||0.6557
72361275|NCT02960217|144233721|SUPERIORITY||LS Mean Difference|2.0|STANDARD_ERROR_OF_MEAN|1.09||0.0935|TWO_SIDED|95.0|-0.4|4.5||Based on an ANCOVA model including covariate for period baseline value, fixed effects for treatment sequence, treatment group, period, and a random effect for participant within the sequence.|ANCOVA|||||4.5|-0.4|0.0935
72361276|NCT02960217|144233721|SUPERIORITY|||||||0.7267|||||||Wilk-Shapiro Test for Normality|||||||0.7267
72361277|NCT02960217|144233722|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.28||0.8329|TWO_SIDED|95.0|-0.6|0.5||Based on an ANCOVA model including covariate for study baseline CGI-S score, fixed effects for treatment sequence, treatment group, period, and a random effect for subject within the sequence.|ANCOVA|||||0.5|-0.6|0.8329
72361278|NCT02960217|144233722|SUPERIORITY|||||||0.2348|||||||Wilk-Shapiro Test for Normality|||||||0.2348
72361279|NCT02960217|144233724|SUPERIORITY|||||||0.0315|||||||Wilk-Shapiro Test for Normality|||||||0.0315
72361280|NCT02960217|144233724|SUPERIORITY||Hodges-Lehmann estimate (Median Diff.)|-0.5||||0.2425|TWO_SIDED|95.0|-1.5|0.5||Hodges-Lehmann estimate of the location shift with 95% CI and Wilcoxon Rank Sum test p-value are based on Wilcoxon rank-sum test.|Wilcoxon Rank Sum test|||Number of participants in this analysis completed both UX007 treatment period and placebo treatment period (n=13).||0.5|-1.5|0.2425
72361281|NCT02960217|144233725|SUPERIORITY|||||||0.0072|||||||Wilk-Shapiro Test for Normality|||||||0.0072
72361282|NCT02960217|144233725|SUPERIORITY||Hodges-Lehmann estimate (Median Diff.)|0.0||||1|TWO_SIDED|95.0|-14.5|13.5||Hodges-Lehmann estimate of the location shift with 95% CI and Wilcoxon Rank Sum test p-value are based on Wilcoxon rank-sum test.|Wilcoxon Rank Sum test|||Number of participants in this analysis completed both UX007 treatment period and placebo treatment period (n=12).||13.5|-14.5|1.0000
72361283|NCT02960217|144233726|SUPERIORITY||LS Mean Difference|1.0|STANDARD_ERROR_OF_MEAN|0.54||0.1076|TWO_SIDED|95.0|-0.3|2.2||Based on an ANCOVA model including covariate for period baseline value, fixed effects for treatment sequence, treatment group, period, and a random effect for subject within the sequence.|ANCOVA|||||2.2|-0.3|0.1076
72361284|NCT02960217|144233726|SUPERIORITY|||||||0.7698|||||||Wilk-Shapiro Test for Normality|||||||0.7698
72361285|NCT02960217|144233727|SUPERIORITY|||||||0.0138|||||||Wilk-Shapiro Test for Normality|||||||0.0138
72361286|NCT02960217|144233727|SUPERIORITY||Hodges-Lehmann estimate (Median Diff.)|2.0||||0.3907|TWO_SIDED|95.0|-3.5|20.5||Hodges-Lehmann estimate of the location shift with 95% CI and Wilcoxon Rank Sum test p-value are based on Wilcoxon rank-sum test.|Wilcoxon Rank Sum test|||Number of participants in this analysis completed both UX007 treatment period and placebo treatment period (n=13).||20.5|-3.5|0.3907
72361287|NCT02960217|144233728|SUPERIORITY||LS Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|1.51||0.5233|TWO_SIDED|95.0|-4.4|2.4||Based on an ANCOVA model including covariate for period baseline value, fixed effects for treatment sequence, treatment group, period, and a random effect for subject within the sequence.|ANCOVA|||||2.4|-4.4|0.5233
72361288|NCT02960217|144233728|SUPERIORITY|||||||0.6918|||||||Wilk-Shapiro Test for Normality|||||||0.6918
72361289|NCT01743469|144233732|SUPERIORITY_OR_OTHER|||||||0.142||||||One-sided alpha of 0.1.|Exact binomial test|||The PFS rate was compared with the prespecified threshold (\>20%).||||0.142
72361290|NCT01743469|144233732|SUPERIORITY_OR_OTHER|||||||1||||||One-sided alpha of 0.1.|Exact binomial test|||The PFS rate was compared with the prespecified threshold (\>35%).||||1.000
72361291|NCT01743469|144233732|SUPERIORITY_OR_OTHER|||||||0.8||||||One-sided alpha of 0.1|Exact binomial test|||The PFS rate was compared with the prespecified threshold (\>20%).||||0.800
72361292|NCT01743469|144233732|SUPERIORITY_OR_OTHER|||||||0.63||||||One-sided alpha of 0.1|Exact binomial test|||The PFS rate was compared with the prespecified threshold (\>15%).||||0.630
72361293|NCT01743469|144233733|SUPERIORITY_OR_OTHER|||||||0.5||||||One-sided alpha of 0.1.|Exact binomial test|||The PFS rate was compared with a prespecified threshold (\>20%).||||0.500
72361294|NCT00168844|144233748|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.142|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|||||ANCOVA|ANCOVA analysis with terms for treatment, smoking status at entry,centre and baseline value.|Tiotropium Respimat 5mcg - Placebo|||||<0.0001
72361295|NCT00168844|144233748|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.161|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001||95.0|||||ANCOVA|ANCOVA analysis with terms for treatment, smoking status at entry,centre and baseline value.|Tiotropium Respimat 10mcg - Placebo|||||<0.0001
72361296|NCT00168844|144233749|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.269|STANDARD_ERROR_OF_MEAN|0.996||0.0011||95.0|||||ANCOVA|The means are adjusted for centre, smoking status at entry and baseline value.|Tiotropium Respimat 5mcg - Placebo|||||0.0011
72361297|NCT00168844|144233749|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.242|STANDARD_ERROR_OF_MEAN|0.999|<|0.0001||95.0|||||ANCOVA|The means are adjusted for centre, smoking status at entry and baseline value.|Tiotropium Respimat 10mcg - Placebo|||||<0.0001
72361298|NCT00168844|144233750|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.053|STANDARD_ERROR_OF_MEAN|0.165|<|0.0001|TWO_SIDED|95.0|||||ANCOVA|The means are adjusted for centre, smoking status at entry and baseline value.|Tiotropium Respimat 5mcg - Placebo|||||<0.0001
72361299|NCT00168844|144233750|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.075|STANDARD_ERROR_OF_MEAN|0.166|<|0.0001||95.0|||||ANCOVA|The means are adjusted for centre, smoking status at entry and baseline value.||||||<0.0001
72361300|NCT00168844|144233751|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.782||||0.0002|TWO_SIDED|95.0|0.687|0.89|||Poisson regression||Tiotropium Respimat 5mcg - Placebo|||0.890|0.687|0.0002
72361301|NCT00168844|144233751|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.725|||<|0.0001|TWO_SIDED|95.0|0.635|0.828|||Poisson regression||Tiotropium Respimat 10mcg - Placebo|||0.828|0.635|<0.0001
72361302|NCT00168844|144233795|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.178|STANDARD_ERROR_OF_MEAN|0.039|<|0.0001||95.0|||||ANCOVA|ANCOVA analysis with terms for treatment, smoking status at entry,centre and baseline value.|Tiotropium Respimat 5mcg - Placebo|Analysis for week 48||||<0.0001
72361303|NCT00168844|144233795|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.323|STANDARD_ERROR_OF_MEAN|0.039|<|0.0001||95.0|||||ANCOVA|ANCOVA analysis with terms for treatment, smoking status at entry,centre and baseline value.|Tiotropium Respimat 10mcg - Placebo|Analysis for week 48||||<0.0001
72361304|NCT00168844|144233796|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.22|STANDARD_ERROR_OF_MEAN|0.021|<|0.0001||95.0|||||ANCOVA|ANCOVA analysis with terms for treatment, smoking status at entry, centre and baseline value.|Tiotropium Respimat 5mcg - Placebo|Analysis for week 48||||<0.0001
72361305|NCT00168844|144233796|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.234|STANDARD_ERROR_OF_MEAN|0.021|<|0.0001||95.0|||||ANCOVA|ANCOVA analysis with terms for treatment, smoking status at entry, centre and baseline value.|Tiotropium Respimat 10mcg - Placebo|Analysis for week 48||||<0.0001
72361306|NCT00168844|144233797|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.31|STANDARD_ERROR_OF_MEAN|0.041|<|0.0001||95.0|||||ANCOVA|ANCOVA analysis with terms for treatment, smoking status at entry, centre and baseline value.|Tiotropium Respimat 5mcg - Placebo|Analysis for week 48||||<0.0001
72361307|NCT00168844|144233797|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.419|STANDARD_ERROR_OF_MEAN|0.041|<|0.0001||95.0|||||ANCOVA|ANCOVA analysis with terms for treatment, smoking status at entry, centre and baseline value.|Tiotropium Respimat 10mcg - Placebo|Analysis for week 48||||<0.0001
72361308|NCT00168844|144233798|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|22.5|STANDARD_ERROR_OF_MEAN|5.3|<|0.0001||95.0|||||ANCOVA|ANCOVA analysis with terms for treatment, centre,smoking status at entry and baseline value.|Tiotropium Respimat 5mcg - Placebo|Analysis for week 48||||<0.0001
72361309|NCT00168844|144233798|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|33.1|STANDARD_ERROR_OF_MEAN|5.3|<|0.0001||95.0|||||ANCOVA|ANCOVA analysis with terms for treatment, centre,smoking status at entry and baseline value.|Tiotropium Respimat 10mcg - Placebo|Analysis for week 48||||<0.0001
72361310|NCT00168844|144233799|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|25.5|STANDARD_ERROR_OF_MEAN|5.6|<|0.0001||95.0|||||ANCOVA|ANCOVA analysis with terms for treatment, centre,smoking status at entry and baseline value.|Tiotropium Respimat 5mcg - Placebo|Analysis for week 48||||<0.0001
72361311|NCT00168844|144233799|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|35.5|STANDARD_ERROR_OF_MEAN|5.6|<|0.0001||95.0|||||ANCOVA|ANCOVA analysis with terms for treatment, centre,smoking status at entry and baseline value.|Tiotropium Respimat 10mcg - Placebo|Analysis for week 48||||<0.0001
72361312|NCT00168844|144233800|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001||95.0|||||ANCOVA|ANCOVA analysis with terms for treatment, centre,smoking status at entry and baseline value.|Tiotropium Respimat 5mcg - Placebo|Analysis for week 48||||<0.0001
72361313|NCT00168844|144233800|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001||95.0|||||ANCOVA|ANCOVA analysis with terms for treatment, centre,smoking status at entry and baseline value.|Tiotropium Respimat 10mcg - Placebo|Analysis for week 48||||<0.0001
72361314|NCT00537394|144233824|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority margin defined as 15 percentage points. If the confidence interval for the difference in regimen failure between omitting versus adding NRTIs was fully below 15 percentage points, then omitting NRTIs would be concluded to be not inferior to adding NRTIs for this outcome.|Risk Difference (RD)|3.2|||||TWO_SIDED|95.0|-6.1|12.5|||||Endpoint rates with standard errors calculated from Kaplan-Meier curves for each treatment group and stratum. Differences in week 48 failure proportions by treatment calculated weighted by the inverse of the variance in each stratum.|Null Hypothesis was that omitting NRTIs is inferior to adding NRTIs for the outcome of regimen failure through 48 weeks.||12.5|-6.1|
72361315|NCT01377584|144233845|OTHER||Effect size|-0.51|||||TWO_SIDED|||||||||||||
72361316|NCT01377584|144233845|OTHER||Effect size|-0.42|||||TWO_SIDED|||||||||||||
72361317|NCT01377584|144233845|OTHER||Effect size|-0.82|||||TWO_SIDED|||||||||||||
72361318|NCT01377584|144233845|OTHER||Effect size|-1.31|||||TWO_SIDED|||||||||||||
72361319|NCT01377584|144233845|OTHER||Effect size|-0.08|||||TWO_SIDED|||||||||||||
72361320|NCT01377584|144233845|OTHER||Effect size|-0.77|||||TWO_SIDED|||||||||||||
72361321|NCT01377584|144233846|OTHER||Effect size|0.51|||||TWO_SIDED|||||||||||||
72361322|NCT01377584|144233846|OTHER||Effect size|0.41|||||TWO_SIDED|||||||||||||
72361323|NCT01377584|144233846|OTHER||Effect size|0.57|||||TWO_SIDED|||||||||||||
72361324|NCT01377584|144233846|OTHER||Effect size|1.54|||||TWO_SIDED|||||||||||||
72361325|NCT01377584|144233846|OTHER||Effect size|0.0|||||TWO_SIDED|||||||||||||
72361326|NCT01377584|144233846|OTHER||Effect size|0.65|||||TWO_SIDED|||||||||||||
72361327|NCT01377584|144233847|OTHER||Effect size|-1.01|||||TWO_SIDED|||||||||||||
72361328|NCT01377584|144233847|OTHER||Effect size|-0.94|||||TWO_SIDED|||||||||||||
72361329|NCT01377584|144233847|OTHER||Effect size|-0.4|||||TWO_SIDED|||||||||||||
72361330|NCT01377584|144233847|OTHER||Effect size|-0.31|||||TWO_SIDED|||||||||||||
72361331|NCT01377584|144233847|OTHER||Effect size|-0.65|||||TWO_SIDED|||||||||||||
72361332|NCT01377584|144233847|OTHER||Effect size|-0.77|||||TWO_SIDED|||||||||||||
72361333|NCT01377584|144233848|OTHER||Effect size|0.52|||||TWO_SIDED||||||||Comparing 1 week to 1 month|||||
72361334|NCT01377584|144233848|OTHER||Effect size|-0.63|||||TWO_SIDED||||||||Comparing 1 month and 3 months|||||
72361335|NCT01377584|144233848|OTHER||Effect size|0.5|||||TWO_SIDED||||||||Comparing 1 week to 1 month|||||
72361336|NCT01377584|144233848|OTHER||Effect size|-0.63|||||TWO_SIDED||||||||Comparing 1 month to 3 months|||||
72361337|NCT01377584|144233848|OTHER||Effect size|-0.92|||||TWO_SIDED||||||||Comparing 1 week to 1 month|||||
72361338|NCT01377584|144233848|OTHER||Effect size|-0.26|||||TWO_SIDED||||||||Comparing 1 month to 3 months|||||
72361339|NCT01247324|144233872|SUPERIORITY_OR_OTHER_LEGACY||Rate Ratio|0.536|||<|0.0001|TWO_SIDED|95.0|0.4|0.719|||Negative Binomial Model||Rate ratio was calculated as Ocrelizumab ARR/Interferon beta-1a 44 mcg SC ARR.|Adjusted by Geographical Region (US vs. Rest of World) and baseline EDSS (\<4.0 vs. \>=4.0).||0.719|0.4|<0.0001
72361340|NCT01247324|144233873|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.57|||=|0.0139|TWO_SIDED|95.0|0.37|0.9|||Log Rank|||Time to onset CDP at week 12||0.90|0.37|= 0.0139
72361341|NCT01247324|144233874|SUPERIORITY_OR_OTHER_LEGACY||Adjusted rate ratio|0.058|||<|0.0001||95.0|0.032|0.104|||Negative Binomial Model||Adjusted by baseline T1 Gd lesion (present or not), baseline EDSS (\<4.0 vs. \>=4.0) and geographical region (US vs. rest-of-world). Adjusted rate ratio was calculated as Ocrelizumab adjusted rate/Interferon beta-1a 44 mcg SC adjusted rate.|||0.104|0.032|< 0.0001
72361342|NCT01247324|144233875|SUPERIORITY_OR_OTHER_LEGACY||Adjusted rate ratio|0.229|||<|0.0001||95.0|0.174|0.3|||Negative Binomial Model||Adjusted by baseline T2 lesion (present or not), baseline EDSS (\<4.0 vs. \>=4.0) and geographical region (US vs. rest-of-world). Adjusted rate ratio was calculated as Ocrelizumab adjusted rate/Interferon beta-1a 44 mcg SC adjusted rate.|||0.300|0.174|< 0.0001
72361343|NCT01247324|144233876|SUPERIORITY_OR_OTHER_LEGACY||Relative risk (stratified)|1.61|||=|0.0106|TWO_SIDED|95.0|1.11|2.33|||CMH Chi-Squared test (stratified)|CMH (Cochran-Mantel-Haenszel) Chi-Squared test Stratified by Geographical Region (US vs. Rest of World) and Baseline EDSS (\<4.0 vs. \>=4.0)||||2.33|1.11|= 0.0106
72361344|NCT01247324|144233877|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.57|||=|0.0278|TWO_SIDED|95.0|0.34|0.95|||Log Rank|||Time to onset CDP at week 24||0.95|0.34|= 0.0278
72361345|NCT01247324|144233878|SUPERIORITY_OR_OTHER_LEGACY||Adjusted rate ratio|0.428|||<|0.0001||95.0|0.328|0.557|||Negative Binomial Model||Adjusted by baseline T1-hypointense lesion count, baseline EDSS (\<4.0 vs. \>=4.0) and geographical region (US vs. rest-of-world). Adjusted rate ratio was calculated as Ocrelizumab adjusted rate/Interferon beta-1a 44 mcg SC adjusted rate.|||0.557|0.328|< 0.0001
72361346|NCT01247324|144233879|SUPERIORITY_OR_OTHER_LEGACY||Difference in Adjusted Means|0.039|STANDARD_ERROR_OF_MEAN|0.039|=|0.3261|TWO_SIDED|95.0|-0.039|0.116|||mixed-effect model of repeated measures|Estimates are from analysis based on mixed-effect model of repeated measures (MMRM) using unstructured covariance matrix.|Difference in adjusted means was calculated as Ocrelizumab adjusted mean at Week 96/ Interferon beta-1a 44 mcg SC adjusted mean at Week 96.|||0.116|-0.039|= 0.3261
72361347|NCT01247324|144233880|SUPERIORITY_OR_OTHER_LEGACY||Difference in Adjusted Means|0.168|STANDARD_ERROR_OF_MEAN|0.058|=|0.0042|TWO_SIDED|95.0|0.053|0.283|||mixed-effect model of repeated measures|Estimates are from analysis based on mixed-effect model of repeated measures (MMRM) using unstructured covariance matrix.|Difference in the rate of brain volume loss: 22.8%. Difference in adjusted means was calculated as Ocrelizumab adjusted mean at Week 96/ Interferon beta-1a 44 mcg SC adjusted mean at Week 96.|||0.283|0.053|= 0.0042
72361348|NCT01247324|144233881|SUPERIORITY_OR_OTHER_LEGACY||Difference in Adjusted Means|0.693|STANDARD_ERROR_OF_MEAN|0.564|=|0.2193|TWO_SIDED|95.0|-0.414|1.8|||mixed-effect model of repeated measures|Estimates are from analysis based on mixed-effect model of repeated measures using unstructured covariance matrix.|Difference in adjusted means was calculated as Ocrelizumab adjusted mean at Week 96/ Interferon beta-1a 44 mcg SC adjusted mean at Week 96.|||1.800|-0.414|= 0.2193
72361349|NCT01247324|144233882|SUPERIORITY_OR_OTHER_LEGACY||Relative risk (stratified)|1.74|||<|0.0001|TWO_SIDED|95.0|1.39|2.17|||CMH Chi-Squared test (stratified)|Analyzed using CMH test, stratified by Geographical Region (US vs. rest-of-world) and baseline EDSS (\<4.0 vs. \>=4.0).||||2.17|1.39|< 0.0001
72361350|NCT00844844|144233920|SUPERIORITY_OR_OTHER||LS mean change from baseline|65.18|||<|0.0001|TWO_SIDED|95.0|37.01|93.36|||ANOVA|Change from baseline were analyzed using a repeated measurement ANOVA model with time and baseline as fixed effects and subject as a random effect.||With at least 12 patients enrolled and assuming a null hypothesis of no post-dose change from baseline in mean platelet count, the study had approximately 88% power to detect as statistically significant an effect size (mean change from baseline/standard deviation) of at least 1 when using a one sample t-test with a two-sided α=0.05. All analyses were based on the pooled data from the two protocols:C08-002A (adult) and C08-002B (Adolescent), a similar protocol, for patients \<18 years with aHUS.||93.36|37.01|<0.0001
72361351|NCT00844844|144233921|SUPERIORITY_OR_OTHER||Percent of platelet count normalization|82.0|||||TWO_SIDED|95.0|57.0|96.0||||||All analyses were based on the pooled data from the two protocols: protocol C08-002A for adult patients with aHUS and protocol C08-002B, a similar protocol, for patients \< 18 years of age for adolescent patients with aHUS.||96|57|
72361352|NCT00844844|144233922|SUPERIORITY_OR_OTHER||Percent of hematologic normalization|76.0|||||TWO_SIDED|95.0|50.0|93.0||||||All analyses were based on the pooled data from the two protocols: protocol C08-002A for adult patients with aHUS and protocol C08-002B, a similar protocol, for patients \< 18 years of age for adolescent patients with aHUS.||93|50|
72361353|NCT00844844|144233923|SUPERIORITY_OR_OTHER||Percent of complete TMA response|65.0|||||TWO_SIDED|95.0|38.0|86.0||||||All analyses were based on the pooled data from the two protocols: protocol C08-002A for adult patients with aHUS and protocol C08-002B, a similar protocol, for patients \< 18 years of age for adolescent patients with aHUS.||86|38|
72361354|NCT00844844|144233924|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.78|||<|0.0001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||All analyses were based on the pooled data from the two protocols: protocol C08-002A for adult patients with aHUS and protocol C08-002B, a similar protocol, for patients \< 18 years of age for adolescent patients with aHUS.||||<0.0001
72361355|NCT00844844|144233925|SUPERIORITY_OR_OTHER||LS mean change from baseline|111.62|||<|0.0001|TWO_SIDED|95.0|98.12|125.13|||ANOVA|Change from baseline was analyzed using a repeated measurement ANOVA model with time and baseline as fixed effects and subject as a random effect.||All analyses were based on the pooled data from the two protocols: protocol C08-002A for adult patients with aHUS and protocol C08-002B, a similar protocol, for patients \< 18 years of age for adolescent patients with aHUS.||125.13|98.12|<0.0001
72361356|NCT00844844|144233926|SUPERIORITY_OR_OTHER||Percent of platelet count normalization|88.0|||||TWO_SIDED|95.0|64.0|99.0||||||All analyses were based on the pooled data from the two protocols: protocol C08-002A for adult patients with aHUS and protocol C08-002B, a similar protocol, for patients \< 18 years of age for adolescent patients with aHUS.||99|64|
72361357|NCT00844844|144233927|SUPERIORITY_OR_OTHER||Percent of hematologic normalization|88.0|||||TWO_SIDED|95.0|64.0|99.0||||||All analyses were based on the pooled data from the two protocols: protocol C08-002A for adult patients with aHUS and protocol C08-002B, a similar protocol, for patients \< 18 years of age for adolescent patients with aHUS.||99|64|
72361358|NCT00844844|144233928|SUPERIORITY_OR_OTHER||Percent of complete TMA response|76.0|||||TWO_SIDED|95.0|50.0|93.0||||||All analyses were based on the pooled data from the two protocols: protocol C08-002A for adult patients with aHUS and protocol C08-002B, a similar protocol, for patients \< 18 years of age for adolescent patients with aHUS.||93|50|
72361359|NCT00844844|144233929|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.78|||<|0.0001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||All analyses were based on the pooled data from the two protocols: protocol C08-002A for adult patients with aHUS and protocol C08-002B, a similar protocol, for patients \< 18 years of age for adolescent patients with aHUS.||||<0.0001
72361360|NCT04886154|144233943|SUPERIORITY|Superiority was to be demonstrated if the lower limit of the 2-sided 97.5% CI for the difference in percentages of samples with bactericidal serum activity is above 5% between the ABCWY low dose\_06 group compared to the Control group at 1 month after the last vaccination.|Difference in percentage|4.67|||||TWO_SIDED|97.5|3.38|5.97|||||The 97.5% CIs for the difference in percentages between ABCWY low dose\_06 group and the control group is constructed using the method of Miettinen and Nurminen.|To demonstrate the superiority of the effectiveness of the MenABCWY-2Gen vaccine (low dose) when administered at 0,6-months schedule, compared to the MenB vaccine administered at 0,6-months schedule.||5.97|3.38|
72369539|NCT01193257|144249352|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.76||||0.00038|TWO_SIDED|95.0|0.653|0.885|||Log Rank|||Hazard ratio is based on a stratified Cox's proportional hazard regression model with stratification factors region (North America, Europe and Rest of World) and brief pain inventory-short form (BPI-SF) worst pain score at screening (\<=4, \>4) with treatment as a factor in the model. A hazard ratio less than 1 for the treatment indicates better prevention of the death in the Orteronel arm as compared to placebo arm.||0.885|0.653|0.00038
72361361|NCT04886154|144233943|SUPERIORITY|Superiority was to be demonstrated if the lower limit of the 2-sided 97.5% CI for the difference in percentages of samples with bactericidal serum activity is above 5% between the ABCWY low dose\_02 group compared to the Control group at 1 month after the last vaccination.|Difference in percentage|-0.17|||||TWO_SIDED|97.5|-1.65|1.3|||||The 97.5% CIs for the difference in percentages between ABCWY low dose\_02 group and the control group is constructed using the method of Miettinen and Nurminen.|To demonstrate the superiority of the effectiveness of the MenABCWY-2Gen vaccine (low dose) when administered at 0,2- months schedule, compared to the MenB vaccine administered at 0,6-months schedule.||1.30|-1.65|
72361362|NCT04886154|144233943|SUPERIORITY|Superiority was to be demonstrated if the lower limit of the 2-sided 97.5% CI for the difference in percentages of samples with bactericidal serum activity is above 5% between the ABCWY high dose\_06 group compared to the Control group at 1 month after the last vaccination.|Difference in percentage|4.6|||||TWO_SIDED|97.5|3.33|5.89|||||The 97.5% CIs for the difference in percentages between ABCWY high dose\_06 group and the control group is constructed using the method of Miettinen and Nurminen.|To demonstrate the superiority of the effectiveness of the MenABCWY-2Gen vaccine (high dose) when administered at 0,6- months schedule, compared to the MenB vaccine administered at 0,6-months schedule.||5.89|3.33|
72361363|NCT04886154|144233943|SUPERIORITY|Superiority was to be demonstrated if the lower limit of the 2-sided 97.5% CI for the difference in percentages of samples with bactericidal serum activity is above 5% between the ABCWY high dose\_02 group compared to the Control group at 1 month after the last vaccination.|Difference in percentage|2.01|||||TWO_SIDED|97.5|0.6|3.42|||||The 97.5% CIs for the difference in percentages between ABCWY high dose\_02 group and the control group is constructed using the method of Miettinen and Nurminen.|To demonstrate the superiority of the effectiveness of the MenABCWY-2Gen vaccine (high dose) when administered at 0,2- months schedule, compared to the MenB vaccine administered at 0,6-months schedule.||3.42|0.60|
72361364|NCT04886154|144233944|NON_INFERIORITY|Non-inferiority (NI) was to be demonstrated if the lower limit of the 2-sided 97.5% CI for the difference in percentages of participants achieving a 4-fold rise in hSBA titres is above -10% at 1 month after the last MenABCWY-2Gen vaccination in the ABCWY low dose\_06 group compared to the MenACWY vaccination in the Control group.|Difference in percentage|3.03|||||TWO_SIDED|97.5|-4.21|10.17|||||The 97.5% CIs for the difference in percentages between ABCWY low dose\_06 group and the control group is constructed using the method of Miettinen and Nurminen.|To demonstrate the immunological non-inferiority of the MenABCWY-2Gen vaccine (low dose) administered at 0,6-months schedule compared to the MenACWY vaccine administered at month 0 in the control group (Men A).||10.17|-4.21|
72361365|NCT04886154|144233944|NON_INFERIORITY|NI was to be demonstrated if the lower limit of the 2-sided 97.5% CI for the difference in percentages of participants achieving a 4-fold rise in hSBA titres is above -10% at 1 month after the last MenABCWY-2Gen vaccination in the ABCWY low dose\_02 group compared to the MenACWY vaccination in the Control group.|Difference in percentage|4.66|||||TWO_SIDED|97.5|-2.71|11.64|||||The 97.5% CIs for the difference in percentages between ABCWY low dose\_02 group and the control group is constructed using the method of Miettinen and Nurminen.|To demonstrate the immunological non-inferiority of the MenABCWY-2Gen vaccine (low dose) administered at 0,2-months schedule compared to the MenACWY vaccine administered at month 0 in the control group (Men A).||11.64|-2.71|
72361366|NCT04886154|144233944|NON_INFERIORITY|NI was to be demonstrated if the lower limit of the 2-sided 97.5% CI for the difference in percentages of participants achieving a 4-fold rise in hSBA titres is above -10% at 1 month after the last MenABCWY-2Gen vaccination in the ABCWY high dose\_06 group compared to the MenACWY vaccination in the Control group.|Difference in percentage|5.48|||||TWO_SIDED|97.5|-0.71|12.25|||||The 97.5% CIs for the difference in percentages between ABCWY high dose\_06 group and the control group is constructed using the method of Miettinen and Nurminen.|To demonstrate the immunological non-inferiority of the MenABCWY-2Gen vaccine (high dose) administered at 0,6-months schedule compared to the MenACWY vaccine administered at month 0 in the control group (Men A).||12.25|-0.71|
72361367|NCT04886154|144233944|NON_INFERIORITY|NI was to be demonstrated if the lower limit of the 2-sided 97.5% CI for the difference in percentages of participants achieving a 4-fold rise in hSBA titres is above -10% at 1 month after the last MenABCWY-2Gen vaccination in the ABCWY high dose\_02 group compared to the MenACWY vaccination in the Control group.|Difference in percentage|3.87|||||TWO_SIDED|97.5|-3.7|10.97|||||The 97.5% CIs for the difference in percentages between ABCWY high dose\_02 group and the control group is constructed using the method of Miettinen and Nurminen.|To demonstrate the immunological non-inferiority of the MenABCWY-2Gen vaccine (high dose) administered at 0,2-months schedule compared to the MenACWY vaccine administered at month 0 in the control group (Men A).||10.97|-3.70|
72361368|NCT04886154|144233944|NON_INFERIORITY|Non-inferiority (NI) was to be demonstrated if the lower limit of the 2-sided 97.5% CI for the difference in percentages of participants achieving a 4-fold rise in hSBA titres is above -10% at 1 month after the last MenABCWY-2Gen vaccination in the ABCWY low dose\_06 group compared to the MenACWY vaccination in the Control group.|Difference in percentage|35.03|||||TWO_SIDED|97.5|25.22|44.75|||||The 97.5% CIs for the difference in percentages between ABCWY low dose\_06 group and the control group is constructed using the method of Miettinen and Nurminen.|To demonstrate the immunological non-inferiority of the MenABCWY-2Gen vaccine (low dose) administered at 0,6-months schedule compared to the MenACWY vaccine administered at month 0 in the control group (Men C).||44.75|25.22|
72361369|NCT04886154|144233944|NON_INFERIORITY|NI was to be demonstrated if the lower limit of the 2-sided 97.5% CI for the difference in percentages of participants achieving a 4-fold rise in hSBA titres is above -10% at 1 month after the last MenABCWY-2Gen vaccination in the ABCWY low dose\_02 group compared to the MenACWY vaccination in the Control group.|Difference in percentage|34.16|||||TWO_SIDED|97.5|23.76|44.1|||||The 97.5% CIs for the difference in percentages between ABCWY low dose\_02 group and the control group is constructed using the method of Miettinen and Nurminen.|To demonstrate the immunological non-inferiority of the MenABCWY-2Gen vaccine (low dose) administered at 0,2-months schedule compared to the MenACWY vaccine administered at month 0 in the control group (Men C).||44.10|23.76|
72369540|NCT01193257|144249353|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Regression, Logistic|||P-values test for odds ratio equal to 1.||||< 0.0001
72369541|NCT01193257|144249354|SUPERIORITY_OR_OTHER|||||||0.12778|||||||Regression, Logistic|||P-values test for odds ratio equal to 1.||||0.12778
72369542|NCT00078897|144249423|OTHER|Negative binomial regression|Risk Ratio (RR)|1.03||||0.68|TWO_SIDED|95.0|0.91|1.16|||Negative binomial regression|||||1.16|0.91|0.68
72361370|NCT04886154|144233944|NON_INFERIORITY|NI was to be demonstrated if the lower limit of the 2-sided 97.5% CI for the difference in percentages of participants achieving a 4-fold rise in hSBA titres is above -10% at 1 month after the last MenABCWY-2Gen vaccination in the ABCWY high dose\_06 group compared to the MenACWY vaccination in the Control group.|Difference in percentage|29.88|||||TWO_SIDED|97.5|19.26|40.19|||||The 97.5% CIs for the difference in percentages between ABCWY high dose\_06 group and the control group is constructed using the method of Miettinen and Nurminen.|To demonstrate the immunological non-inferiority of the MenABCWY-2Gen vaccine (high dose) administered at 0,6-months schedule compared to the MenACWY vaccine administered at month 0 in the control group (Men C).||40.19|19.26|
72361371|NCT04886154|144233944|NON_INFERIORITY|NI was to be demonstrated if the lower limit of the 2-sided 97.5% CI for the difference in percentages of participants achieving a 4-fold rise in hSBA titres is above -10% at 1 month after the last MenABCWY-2Gen vaccination in the ABCWY high dose\_02 group compared to the MenACWY vaccination in the Control group.|Difference in percentage|33.54|||||TWO_SIDED|97.5|23.09|43.54|||||The 97.5% CIs for the difference in percentages between ABCWY high dose\_02 group and the control group is constructed using the method of Miettinen and Nurminen.|To demonstrate the immunological non-inferiority of the MenABCWY-2Gen vaccine (high dose) administered at 0,2-months schedule compared to the MenACWY vaccine administered at month 0 in the control group (Men C).||43.54|23.09|
72361372|NCT04886154|144233944|NON_INFERIORITY|Non-inferiority (NI) was to be demonstrated if the lower limit of the 2-sided 97.5% CI for the difference in percentages of participants achieving a 4-fold rise in hSBA titres is above -10% at 1 month after the last MenABCWY-2Gen vaccination in the ABCWY low dose\_06 group compared to the MenACWY vaccination in the Control group.|Difference in percentage|30.88|||||TWO_SIDED|97.5|21.61|40.32|||||The 97.5% CIs for the difference in percentages between ABCWY low dose\_06 group and the control group is constructed using the method of Miettinen and Nurminen.|To demonstrate the immunological non-inferiority of the MenABCWY-2Gen vaccine (low dose) administered at 0,6-months schedule compared to the MenACWY vaccine administered at month 0 in the control group (Men W).||40.32|21.61|
72361373|NCT04886154|144233944|NON_INFERIORITY|NI was to be demonstrated if the lower limit of the 2-sided 97.5% CI for the difference in percentages of participants achieving a 4-fold rise in hSBA titres is above -10% at 1 month after the MenABCWY-2Gen MenACWY vaccination in the ABCWY low dose\_02 group compared to the MenACWY vaccination in the Control group.|Difference in percentage|29.35|||||TWO_SIDED|97.5|19.31|39.08|||||The 97.5% CIs for the difference in percentages between ABCWY low dose\_02 group and the control group is constructed using the method of Miettinen and Nurminen.|To demonstrate the immunological non-inferiority of the MenABCWY-2Gen vaccine (low dose) administered at 0,2-months schedule compared to the MenACWY vaccine administered at month 0 in the control group (Men W).||39.08|19.31|
72361374|NCT04886154|144233944|NON_INFERIORITY|NI was to be demonstrated if the lower limit of the 2-sided 97.5% CI for the difference in percentages of participants achieving a 4-fold rise in hSBA titres is above -10% at 1 month after the last MenABCWY-2Gen vaccination in the ABCWY high dose\_06 group compared to the MenACWY vaccination in the Control group.|Difference in percentage|29.02|||||TWO_SIDED|97.5|19.42|38.67|||||The 97.5% CIs for the difference in percentages between ABCWY high dose\_06 group and the control group is constructed using the method of Miettinen and Nurminen.|To demonstrate the immunological non-inferiority of the MenABCWY-2Gen vaccine (high dose) administered at 0,6-months schedule compared to the MenACWY vaccine administered at month 0 in the control group (Men W).||38.67|19.42|
72361375|NCT04886154|144233944|NON_INFERIORITY|NI was to be demonstrated if the lower limit of the 2-sided 97.5% CI for the difference in percentages of participants achieving a 4-fold rise in hSBA titres is above -10% at 1 month after the last MenABCWY-2Gen vaccination in the ABCWY high dose\_02 group compared to the MenACWY vaccination in the Control group.|Difference in percentage|25.13|||||TWO_SIDED|97.5|14.2|35.45|||||The 97.5% CIs for the difference in percentages between ABCWY high dose\_02 group and the control group is constructed using the method of Miettinen and Nurminen.|To demonstrate the immunological non-inferiority of the MenABCWY-2Gen vaccine (high dose) administered at 0,2-months schedule compared to the MenACWY vaccine administered at month 0 in the control group (Men W).||35.45|14.20|
72361376|NCT04886154|144233944|NON_INFERIORITY|Non-inferiority (NI) was to be demonstrated if the lower limit of the 2-sided 97.5% CI for the difference in percentages of participants achieving a 4-fold rise in hSBA titres is above -10% at 1 month after the last MenABCWY-2Gen vaccination in the ABCWY low dose\_06 group compared to the MenACWY vaccination in the Control group.|Difference in percentage|33.38|||||TWO_SIDED|97.5|23.08|43.26|||||The 97.5% CIs for the difference in percentages between ABCWY low dose\_06 group and the control group is constructed using the method of Miettinen and Nurminen.|To demonstrate the immunological non-inferiority of the MenABCWY-2Gen vaccine (low dose) administered at 0,6-months schedule compared to the MenACWY vaccine administered at month 0 in the control group (Men Y).||43.26|23.08|
72361377|NCT04886154|144233944|NON_INFERIORITY|NI was to be demonstrated if the lower limit of the 2-sided 97.5% CI for the difference in percentages of participants achieving a 4-fold rise in hSBA titres is above -10% at 1 month after the last MenABCWY-2Gen vaccination in the ABCWY low dose\_02 group compared to the MenACWY vaccination in the Control group.|Difference in percentage|28.18|||||TWO_SIDED|97.5|16.61|38.86|||||The 97.5% CIs for the difference in percentages between ABCWY low dose\_02 group and the control group is constructed using the method of Miettinen and Nurminen.|To demonstrate the immunological non-inferiority of the MenABCWY-2Gen vaccine (low dose) administered at 0,2-months schedule compared to the MenACWY vaccine administered at month 0 in the control group (Men Y).||38.86|16.61|
72369543|NCT02654769|144249454|EQUIVALENCE|Difference (Generic- Picato)|90% Wald's confidence interval|-1.87|||<|0.0001|TWO_SIDED|90.0|-12.37|8.63|||Fisher Exact|||||8.63|-12.37|<0.0001
72369544|NCT02654769|144249455|EQUIVALENCE|Difference (Generic - Picato)|90% Wald's confidence interval|-2.64|||<|0.0001|TWO_SIDED|90.0|-13.14|7.86|||Fisher Exact|||Partial Clearance at Week 8||7.86|-13.14|<0.0001
72369545|NCT00233064|144249499|SUPERIORITY_OR_OTHER||Overall percentage of immune reactivity|0.0||||||95.0|0.0|1.9|||||The number and percentage of subjects with immune reactivity at Study Day 240-300 were constructed using the Clopper-Pearson Method.|The subject number of 200 per treatment group was derived to demonstrate a percentage of immune reactivity in either the liquid or lyophilized formulations of palivizumab of \<2-3% based on 95% confidence intervals \[(0%; 0.00, 1.83), (0.5%; 0.01, 2.75), (1%; 0.12, 3.57)\].||1.9|0.0|
72361378|NCT04886154|144233944|NON_INFERIORITY|NI was to be demonstrated if the lower limit of the 2-sided 97.5% CI for the difference in percentages of participants achieving a 4-fold rise in hSBA titres is above -10% at 1 month after the last MenABCWY-2Gen vaccination in the ABCWY high dose\_06 group compared to the MenACWY vaccination in the Control group.|Difference in percentage|29.37|||||TWO_SIDED|97.5|18.67|39.63|||||The 97.5% CIs for the difference in percentages between ABCWY high dose\_06 group and the control group is constructed using the method of Miettinen and Nurminen.|To demonstrate the immunological non-inferiority of the MenABCWY-2Gen vaccine (high dose) administered at 0,6-months schedule compared to the MenACWY vaccine administered at month 0 in the control group (Men Y).||39.63|18.67|
72361379|NCT04886154|144233944|NON_INFERIORITY|NI was to be demonstrated if the lower limit of the 2-sided 97.5% CI for the difference in percentages of participants achieving a 4-fold rise in hSBA titres is above -10% at 1 month after the last MenABCWY-2Gen vaccination in the ABCWY high dose\_02 group compared to the MenACWY vaccination in the Control group.|Difference in percentage|27.21|||||TWO_SIDED|97.5|15.46|38.02|||||The 97.5% CIs for the difference in percentages between ABCWY high dose\_02 group and the control group is constructed using the method of Miettinen and Nurminen.|To demonstrate the immunological non-inferiority of the MenABCWY-2Gen vaccine (high dose) administered at 0,2-months schedule compared to the MenACWY vaccine administered at month 0 in the control group (Men Y).||38.02|15.46|
72361380|NCT03593044|144234017|OTHER|||||||0.002|||||||t-test, 2 sided|||Photopic pupil size||||0.002
72361381|NCT03593044|144234017|OTHER|||||||0.66|||||||t-test, 2 sided|||Mesopic pupil size||||0.66
72361382|NCT03593044|144234018|OTHER|||||||0.96|||||||t-test, 2 sided|||High contrast distance visual acuity||||0.96
72361383|NCT03593044|144234018|OTHER|||||||0.77|||||||t-test, 2 sided|||High contrast near visual acuity||||0.77
72361384|NCT03593044|144234018|OTHER|||||||0.82|||||||t-test, 2 sided|||Low contrast distance visual acuity||||0.82
72361385|NCT03593044|144234019|OTHER|||||||0.1|||||||t-test, 2 sided|||Accommodative amplitude||||0.10
72361386|NCT03593044|144234019|OTHER|||||||0.66|||||||t-test, 2 sided|||Accommodative lag||||0.66
72361387|NCT03593044|144234019|OTHER|||||||0.24|||||||t-test, 2 sided|||Accommodative facility||||0.24
72361388|NCT03593044|144234020|OTHER|||||||0.3|||||||t-test, 2 sided|||Glare||||0.3
72361389|NCT03593044|144234020|OTHER|||||||0.5|||||||t-test, 2 sided|||Ghost images||||0.5
72361390|NCT03593044|144234020|OTHER|||||||0.9|||||||t-test, 2 sided|||Strain/tiredness||||0.9
72361391|NCT03593044|144234020|OTHER|||||||0.9|||||||t-test, 2 sided|||Changing vision||||0.9
72361392|NCT03593044|144234020|OTHER|||||||0.3|||||||t-test, 2 sided|||Headache frequency||||0.3
72361393|NCT03593044|144234020|OTHER|||||||0.7|||||||t-test, 2 sided|||Distance clarity||||0.7
72361394|NCT03593044|144234020|OTHER|||||||0.3|||||||t-test, 2 sided|||Computer clarity||||0.3
72361395|NCT03593044|144234020|OTHER|||||||0.1|||||||t-test, 2 sided|||Small print clarity||||0.1
72361396|NCT03593044|144234020|OTHER|||||||1|||||||t-test, 2 sided|||Vision during sports/hobbies||||1.0
72361397|NCT03593044|144234020|OTHER|||||||0.2|||||||t-test, 2 sided|||Overall vision||||0.2
72361398|NCT03593044|144234020|OTHER|||||||0.7|||||||t-test, 2 sided|||Light sensitivity||||0.7
72361399|NCT03593044|144234020|OTHER|||||||0.002|||||||t-test, 2 sided|||Discomfort during bright light||||0.002
72361400|NCT03593044|144234021|OTHER|||||||0.001|||||||t-test, 2 sided|||Right eye intraocular pressure||||0.001
72361401|NCT03593044|144234021|OTHER|||||||0.05|||||||t-test, 2 sided|||Left eye intraocular pressure||||0.05
72361402|NCT03270436|144234045|SUPERIORITY|||||||0.3599||||||The p-value above reflects results of between-arms analysis of change in mean weight from baseline to immediate post-intervention. Analyses do not include imputed values.|linear mixed effects regression|Model includes group, time, g x t interaction, state, age, gender, marital status, employment, education, and accounts for clustering within churches.||Repeated measures regression model used all available participant data (no listwise deletion).||||0.3599
72361403|NCT03270436|144234045|SUPERIORITY|||||||0.3207||||||The p-value above reflects results of between-arms analysis of change in mean weight from baseline to 6 months post-intervention. Analyses do not include imputed values.|linear mixed effects regression|Model includes group, time, g x t interaction, state, age, gender, marital status, employment, education, and accounts for clustering within churches.||Repeated measures regression model used all available participant data (no listwise deletion).||||0.3207
72361404|NCT03270436|144234046|SUPERIORITY|||||||0.5698||||||The p-value above reflects results of between-arms analysis of mean change in HbA1c from baseline to immediate post-intervention. Analyses do not include imputed values.|linear mixed effects regression|Model includes group, time, g x t interaction, state, age, gender, marital status, employment, education, and accounts for clustering within churches.||Repeated measures regression model used all available participant data (no listwise deletion).||||0.5698
72361405|NCT03270436|144234046|SUPERIORITY|||||||0.4106||||||The p-value above reflects results of between-arms analysis of mean change in HbA1c from baseline to 6 months post-intervention. Analyses do not include imputed values.|linear mixed effects regression|Model includes group, time, g x t interaction, state, age, gender, marital status, employment, education, and accounts for clustering within churches.||Repeated measures regression model used all available participant data (no listwise deletion).||||0.4106
72361406|NCT03270436|144234047|SUPERIORITY|||||||0.0293||||||The p-value above reflects results of between-arms analysis of mean change in systolic blood pressure from baseline to immediate post-intervention. Analyses do not include imputed values.|linear mixed effects regression|Model includes group, time, g x t interaction, state, age, gender, marital status, employment, education, and accounts for clustering within churches.||Repeated measures regression model used all available participant data (no listwise deletion).||||0.0293
72361407|NCT03270436|144234047|SUPERIORITY|||||||0.4686||||||The p-value above reflects results of between-arms analysis of mean change in systolic blood pressure from baseline to 6 months post-intervention. Analyses do not include imputed values.|linear mixed effects regression|Model includes group, time, g x t interaction, state, age, gender, marital status, employment, education, and accounts for clustering within churches.||Repeated measures regression model used all available participant data (no listwise deletion).||||0.4686
72361408|NCT03270436|144234048|SUPERIORITY|||||||0.0068||||||The p-value above reflects results of between-arms analysis of mean change in diastolic blood pressure from baseline to immediate post-intervention. Analyses do not include imputed values.|linear mixed effects regression|Model includes group, time, g x t interaction, state, age, gender, marital status, employment, education, and accounts for clustering within churches.||Repeated measures regression model used all available participant data (no listwise deletion).||||0.0068
72361409|NCT03270436|144234048|SUPERIORITY|||||||0.9181||||||The p-value above reflects results of between-arms analysis of mean change in diastolic blood pressure from baseline to 6 months post-intervention. Analyses do not include imputed values.|linear mixed effects regression|Model includes group, time, g x t interaction, state, age, gender, marital status, employment, education, and accounts for clustering within churches.||Repeated measures regression model used all available participant data (no listwise deletion).||||0.9181
72361410|NCT03270436|144234049|SUPERIORITY|||||||0.5984||||||The p-value above reflects results of between-arms analysis of mean change in sugar-sweetened beverages consumed per day from baseline to immediate post-intervention. Analyses do not include imputed values.|linear mixed effects regression|Model includes group, time, g x t interaction, state, age, gender, marital status, employment, education, and accounts for clustering within churches.||Repeated measures regression model used all available participant data (no listwise deletion).||||0.5984
72361411|NCT03270436|144234049|SUPERIORITY|||||||0.3376||||||The p-value above reflects results of between-arms analysis of mean change in sugar-sweetened beverages consumed per day from baseline to 6 months post-intervention. Analyses do not include imputed values.|linear mixed effects regression|Model includes group, time, g x t interaction, state, age, gender, marital status, employment, education, and accounts for clustering within churches.||Repeated measures regression model used all available participant data (no listwise deletion).||||0.3376
72361412|NCT03270436|144234050|SUPERIORITY|||||||0.296||||||The p-value above reflects results of between-arms analysis of mean change in fruit \& vegetable consumption scores from baseline to immediate post-intervention. Analyses do not include imputed values.|linear mixed effects regression|Model includes group, time, g x t interaction, state, age, gender, marital status, employment, education, and accounts for clustering within churches.||Repeated measures regression model used all available participant data (no listwise deletion).||||0.2960
72361413|NCT03270436|144234050|SUPERIORITY|||||||0.1519||||||The p-value above reflects results of between-arms analysis of mean change in fruit \& vegetable consumption scores from baseline to 6 months post-intervention. Analyses do not include imputed values.|linear mixed effects regression|Model includes group, time, g x t interaction, state, age, gender, marital status, employment, education, and accounts for clustering within churches.||Repeated measures regression model used all available participant data (no listwise deletion).||||0.1519
72361414|NCT03270436|144234051|SUPERIORITY|||||||0.2824||||||The p-value above reflects results of between-arms analysis of change from baseline to immediate post-intervention. Analyses do not include imputed values.|Mantel Haenszel|The model includes only the study arm and time interaction.||Adjusted repeated measures generalized estimating equations (GEE) model.||||0.2824
72361415|NCT03270436|144234051|SUPERIORITY|||||||0.7547||||||The p-value above reflects results of between-arms analysis of change from baseline to 6 months post-intervention. Analyses do not include imputed values.|Mantel Haenszel|The model includes only the study arm and time interaction.||Adjusted repeated measures generalized estimating equations (GEE) model.||||0.7547
72361416|NCT03270436|144234052|SUPERIORITY|||||||0.6928||||||The p-value above reflects results of between-arms analysis of mean change in eating self-efficacy scores from baseline to immediate post-intervention. Analyses do not include imputed values.|linear mixed effects regression|Model includes group, time, g x t interaction, state, age, gender, marital status, employment, education, and accounts for clustering within churches.||Repeated measures regression model used all available participant data (no listwise deletion).||||0.6928
72361417|NCT03270436|144234052|SUPERIORITY|||||||0.4947||||||The p-value above reflects results of between-arms analysis of mean change in eating self-efficacy scores from baseline to 6 months post-intervention. Analyses do not include imputed values.|linear mixed effects regression|Model includes group, time, g x t interaction, state, age, gender, marital status, employment, education, and accounts for clustering within churches.||Repeated measures regression model used all available participant data (no listwise deletion).||||0.4947
72361418|NCT03270436|144234053|SUPERIORITY|||||||0.1539||||||The p-value above reflects results of between-arms analysis of mean change in physical activity self-efficacy scores from baseline to immediate post-intervention. Analyses do not include imputed values|linear mixed effects regression|Model includes group, time, g x t interaction, state, age, gender, marital status, employment, education, and accounts for clustering within churches.||Repeated measures regression model used all available participant data (no listwise deletion).||||0.1539
72361419|NCT03270436|144234053|SUPERIORITY|||||||0.1878||||||The p-value above reflects results of between-arms analysis of mean change in physical activity self-efficacy scores from baseline to 6 months post-intervention. Analyses do not include imputed values.|linear mixed effects regression|Model includes group, time, g x t interaction, state, age, gender, marital status, employment, education, and accounts for clustering within churches.||Repeated measures regression model used all available participant data (no listwise deletion).||||0.1878
72361420|NCT03270436|144234054|SUPERIORITY|||||||0.4322||||||The p-value above reflects results of between-arms analysis of mean change in family support scale scores from baseline to immediate post-intervention. Analyses do not include imputed values.|linear mixed effects regression|Model includes group, time, g x t interaction, state, age, gender, marital status, employment, education, and accounts for clustering within churches.||Repeated measures regression model used all available participant data (no listwise deletion).||||0.4322
72361421|NCT03270436|144234054|SUPERIORITY|||||||0.9529||||||The p-value above reflects results of between-arms analysis of mean change in family support scale scores from baseline to 6 months post-intervention. Analyses do not include imputed values.|linear mixed effects regression|Model includes group, time, g x t interaction, state, age, gender, marital status, employment, education, and accounts for clustering within churches.||Repeated measures regression model used all available participant data (no listwise deletion).||||0.9529
72361422|NCT03631940|144234111|SUPERIORITY||Least squares mean difference|-0.49||||0.87|TWO_SIDED|95.0|-6.36|5.37|||Hierarchical generalized linear mixed mo|Hierarchical generalized linear mixed models||||5.37|-6.36|.87
72361423|NCT00836589|144234134|NON_INFERIORITY|"Estimated SAEFR at 5 years is 92.5% with a 5% non-inferiority margin (87.5%).~Type I error (alpha) is 0.05 (one-sided for non-inferiority).~Statistical power is 80%."||||||0.002|||||||Binomial Proportion|||||||0.0020
72361424|NCT01890343|144234150|SUPERIORITY_OR_OTHER|||||||0.002|||||||Kruskal-Wallis|||The effect of diagnostic group on mean cortical florbetapir binding relative to cerebellar cortex was determined.||||0.002
72361425|NCT00772538|144234180|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.086|STANDARD_ERROR_OF_MEAN|0.034||0.011||95.0|0.02|0.152||Step-wise testing for co-primary endpoints, confirmatory only if previous hypotheses had been successful, significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment\*visit and baseline\*visit.|||0.152|0.020|0.0110
72361426|NCT00772538|144234181|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.088|STANDARD_ERROR_OF_MEAN|0.031||0.005||95.0|0.027|0.149||Step-wise testing for co-primary endpoints, confirmatory only if previous hypotheses had been successful, significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment\*visit and baseline\*visit.|||0.149|0.027|0.0050
72361427|NCT00772538|144234182|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.79||||0.0343||||||Confirmatory only if previous hypotheses for each of the 2 twin studies had been successful, significance level of alpha=0.05 (2-sided). A pre-specified interim analysis was performed. Cui et al (Biometrics,1999) was used to calculate the p-value.|Regression, Cox|Parameter estimates of Cox proportional hazard model regression regarding. Only treatment was fitted as an effect in the model.|If HR is below 1 then favours tiotropium.|||||0.0343
72361428|NCT00772538|144234183|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.089|STANDARD_ERROR_OF_MEAN|0.043||0.0362||95.0|0.006|0.173||Significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment\*visit and baseline\*visit.|||0.173|0.006|0.0362
72361429|NCT00772538|144234184|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.136|STANDARD_ERROR_OF_MEAN|0.04||0.0007||95.0|0.058|0.214||Significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment\*visit and baseline\*visit.|||0.214|0.058|0.0007
72361430|NCT00772538|144234185|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.086|STANDARD_ERROR_OF_MEAN|0.032||0.0067||95.0|0.024|0.149||Significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment\*visit and baseline\*visit.|||0.149|0.024|0.0067
72361431|NCT00772538|144234186|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.098|STANDARD_ERROR_OF_MEAN|0.04||0.0139||95.0|0.02|0.176||Significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment\*visit and baseline\*visit.|||0.176|0.020|0.0139
72361432|NCT00772538|144234187|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.073|STANDARD_ERROR_OF_MEAN|0.034||0.0347||95.0|0.005|0.14||Significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment\*visit and baseline\*visit.|||0.140|0.005|0.0347
72361433|NCT00772538|144234188|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.042|STANDARD_ERROR_OF_MEAN|0.032||0.1896||95.0|-0.021|0.104||Significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment\*visit and baseline\*visit.|||0.104|-0.021|0.1896
72361434|NCT00772538|144234189|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.073|STANDARD_ERROR_OF_MEAN|0.032||0.0247||95.0|0.009|0.136||Significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment\*visit and baseline\*visit.|||0.136|0.009|0.0247
72361435|NCT00772538|144234190|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.125|STANDARD_ERROR_OF_MEAN|0.043||0.0039||95.0|0.04|0.21||Significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment\*visit and baseline\*visit.|||0.210|0.040|0.0039
72361436|NCT00772538|144234191|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.111|STANDARD_ERROR_OF_MEAN|0.04||0.0063||95.0|0.031|0.19||Significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment\*visit and baseline\*visit.|||0.190|0.031|0.0063
72361437|NCT00772538|144234192|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.122|STANDARD_ERROR_OF_MEAN|0.041||0.0027||95.0|0.042|0.201||Significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment\*visit and baseline\*visit.|||0.201|0.042|0.0027
72361438|NCT00772538|144234193|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|22.293|STANDARD_ERROR_OF_MEAN|4.584|<|0.0001||95.0|13.279|31.308||Significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment\*visit and baseline\*visit.|||31.308|13.279|<0.0001
72361439|NCT00772538|144234194|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|23.267|STANDARD_ERROR_OF_MEAN|4.699|<|0.0001||95.0|14.027|32.507||Significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment\*visit and baseline\*visit.|||32.507|14.027|<0.0001
72361440|NCT00772538|144234195|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.117|STANDARD_ERROR_OF_MEAN|0.028|<|0.0001||95.0|0.061|0.173||Significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment\*visit and baseline\*visit.|||0.173|0.061|<0.0001
72361441|NCT00772538|144234196|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.124|STANDARD_ERROR_OF_MEAN|0.029|<|0.0001||95.0|0.068|0.181||Significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment\*visit and baseline\*visit.|||0.181|0.068|<0.0001
72361442|NCT00772538|144234197|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.283|STANDARD_ERROR_OF_MEAN|0.736||0.7012||95.0|-1.165|1.731||Significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment\*visit and baseline\*visit.|||1.731|-1.165|0.7012
72361443|NCT00772538|144234198|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.7||||0.0499||95.0|0.49|1.0||Significance level of alpha=0.05 (two-sided).|Regression, Cox|Parameter estimates of Cox proportional hazard model regarding. Only treatment was fitted as an effect in the model.|If HR is below 1 then favours tiotropium.|||1.00|0.49|0.0499
72361444|NCT00772538|144234199|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.71|STANDARD_ERROR_OF_MEAN|0.09||0.0102||95.0|0.55|0.92||Significance level of alpha=0.05 (two-sided).|Poisson Regression|Parameter estimates of Poisson regression model. Log exposure was used as offset and adjusted for overdispersion.|Tio R5 - Placebo|||0.92|0.55|0.0102
72361445|NCT00772538|144234200|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.64|STANDARD_ERROR_OF_MEAN|0.1||0.0062||95.0|0.46|0.88||Significance level of alpha=0.05 (two-sided).|Poisson Regression|Parameter estimates of Poisson regression model. Log exposure was used as offset and adjusted for overdispersion.|Tio R5 - Placebo|||0.88|0.46|0.0062
72361446|NCT00772538|144234201|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.59||||0.0065||95.0|0.4|0.88||Significance level of alpha=0.05 (two-sided).|Fisher Exact|Exact 95percent confidence interval by Clopper and Pearson.|Tio R5 vs Placebo|||0.88|0.40|0.0065
72361447|NCT00772538|144234202|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.65||||0.0561||95.0|0.42|1.01||Significance level of alpha=0.05 (two-sided).|Fisher Exact|Exact 95percent confidence interval by Clopper and Pearson.|Tio R5 vs Placebo|||1.01|0.42|0.0561
72361448|NCT00772538|144234203|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.76||||0.5604||95.0|0.3|1.92||Significance level of alpha=0.05 (two-sided).|Regression, Cox|Parameter estimates of Cox proportional hazard model regarding. Only treatment was fitted as an effect in the model.|If HR is below 1 then favours tiotropium|||1.92|0.30|0.5604
72361449|NCT00772538|144234204|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.87|STANDARD_ERROR_OF_MEAN|0.21||0.5538||95.0|0.54|1.39||Significance level of alpha=0.05 (two-sided).|Poisson Regression|Parameter estimates of Poisson regression model. Log exposure was used as offset and adjusted for overdispersion.|Tio R5 - Placebo|||1.39|0.54|0.5538
72361450|NCT00772538|144234205|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.74||||0.633||95.0|0.25|2.13||Significance level of alpha=0.05 (two-sided).|Fisher Exact|Exact 95percent confidence interval by Clopper and Pearson.|Tio R5 vs Placebo|||2.13|0.25|0.6330
72361451|NCT00772538|144234206|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.042|STANDARD_ERROR_OF_MEAN|0.074||0.5714||95.0|-0.103|0.186||Significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment\*visit and baseline\*visit.|||0.186|-0.103|0.5714
72361452|NCT00772538|144234207|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.038|STANDARD_ERROR_OF_MEAN|0.075||0.6099||95.0|-0.109|0.185||Significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment\*visit and baseline\*visit.|||0.185|-0.109|0.6099
72361453|NCT00772538|144234208|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.126|STANDARD_ERROR_OF_MEAN|0.066||0.0586||95.0|-0.256|0.005||Significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment\*visit and baseline\*visit.|||0.005|-0.256|0.0586
72361454|NCT00772538|144234209|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.121|STANDARD_ERROR_OF_MEAN|0.067||0.0727||95.0|-0.253|0.011||Significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment\*visit and baseline\*visit.|||0.011|-0.253|0.0727
72361455|NCT00772538|144234210|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.001|STANDARD_ERROR_OF_MEAN|0.024||0.9807||95.0|-0.048|0.047||Significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment\*visit and baseline\*visit.|||0.047|-0.048|0.9807
72361456|NCT00772538|144234211|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.092|STANDARD_ERROR_OF_MEAN|0.172||0.5927||95.0|-0.43|0.246||Significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment\*visit and baseline\*visit.|||0.246|-0.430|0.5927
72361457|NCT00772538|144234212|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.32||||0.0427|TWO_SIDED|95.0|1.01|1.73||Calculated as 2\*one-sided-p-value in the direction corresponding to testing the null hypothesis|Fisher Exact||Tio R5 / Placebo|Comparison at 24 weeks||1.73|1.01|0.0427
72361458|NCT00772538|144234212|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.68||||0.0001|TWO_SIDED|95.0|1.28|2.21||Calculated as 2\*one-sided-p-value in the direction corresponding to testing the null hypothesis|Fisher Exact||Tio R5 / Placebo|Comparison at 48 weeks||2.21|1.28|0.0001
72361459|NCT00713609|144234215|SUPERIORITY_OR_OTHER|||||||0.692||||||For ILC|ANCOVA|||||||0.692
72361460|NCT00713609|144234215|SUPERIORITY_OR_OTHER|||||||0.467||||||For ILC|ANCOVA|||||||0.467
72361461|NCT00713609|144234215|SUPERIORITY_OR_OTHER|||||||0.281||||||For ILC|ANCOVA|||||||0.281
72361462|NCT00713609|144234215|SUPERIORITY_OR_OTHER|||||||0.075||||||For ILC|ANCOVA|||||||0.075
72361463|NCT00713609|144234215|SUPERIORITY_OR_OTHER||||||<|0.001||||||For ILC|ANCOVA|||||||<0.001
72361464|NCT00713609|144234215|SUPERIORITY_OR_OTHER||||||<|0.001||||||For NILC|ANCOVA|||||||<0.001
72361465|NCT00713609|144234215|SUPERIORITY_OR_OTHER|||||||0.803||||||For NILC|ANCOVA|||||||0.803
72361466|NCT00713609|144234215|SUPERIORITY_OR_OTHER|||||||0.175||||||For NILC|ANCOVA|||||||0.175
72361467|NCT00713609|144234215|SUPERIORITY_OR_OTHER|||||||0.552||||||For NILC|ANCOVA|||||||0.552
72361468|NCT00713609|144234215|SUPERIORITY_OR_OTHER||||||<|0.001||||||For NILC|ANCOVA|||||||<0.001
72361469|NCT00713609|144234215|SUPERIORITY_OR_OTHER|||||||0.006||||||For TC|ANCOVA|||||||0.006
72361470|NCT00713609|144234215|SUPERIORITY_OR_OTHER|||||||0.618||||||For TC|ANCOVA|||||||0.618
72361471|NCT00713609|144234215|SUPERIORITY_OR_OTHER|||||||0.149||||||For TC|ANCOVA|||||||0.149
72361472|NCT00713609|144234215|SUPERIORITY_OR_OTHER|||||||0.255||||||For TC|ANCOVA|||||||0.255
72361473|NCT00713609|144234215|SUPERIORITY_OR_OTHER||||||<|0.001||||||For TC|ANCOVA|||||||<0.001
72361474|NCT00713609|144234216|SUPERIORITY_OR_OTHER|||||||0.922|||||||Cochran-Mantel-Haenszel|||||||0.922
72361475|NCT00713609|144234216|SUPERIORITY_OR_OTHER|||||||0.132|||||||Cochran-Mantel-Haenszel|||||||0.132
72361476|NCT00713609|144234216|SUPERIORITY_OR_OTHER|||||||0.02|||||||Cochran-Mantel-Haenszel|||||||0.020
72361477|NCT00713609|144234216|SUPERIORITY_OR_OTHER|||||||0.706|||||||Cochran-Mantel-Haenszel|||||||0.706
72361478|NCT00713609|144234216|SUPERIORITY_OR_OTHER|||||||0.009|||||||Cochran-Mantel-Haenszel|||||||0.009
72361479|NCT00713609|144234217|SUPERIORITY_OR_OTHER|||||||0.504||||||For ILC|ANCOVA|||||||0.504
72361480|NCT00713609|144234217|SUPERIORITY_OR_OTHER|||||||0.504||||||For ILC|ANCOVA|||||||0.504
72361481|NCT00713609|144234217|SUPERIORITY_OR_OTHER|||||||0.177||||||For ILC|ANCOVA|||||||0.177
72361482|NCT00713609|144234217|SUPERIORITY_OR_OTHER|||||||0.084||||||For ILC|ANCOVA|||||||0.084
72361483|NCT00713609|144234217|SUPERIORITY_OR_OTHER||||||<|0.001||||||For ILC|ANCOVA|||||||<0.001
72361484|NCT00713609|144234217|SUPERIORITY_OR_OTHER||||||<|0.001||||||For NILC|ANCOVA|||||||<0.001
72361485|NCT00713609|144234217|SUPERIORITY_OR_OTHER|||||||0.776||||||For NILC|ANCOVA|||||||0.776
72361486|NCT00713609|144234217|SUPERIORITY_OR_OTHER|||||||0.465||||||For NILC|ANCOVA|||||||0.465
72361487|NCT00713609|144234217|SUPERIORITY_OR_OTHER|||||||0.288||||||For NILC|ANCOVA|||||||0.288
72361488|NCT00713609|144234217|SUPERIORITY_OR_OTHER||||||<|0.001||||||For NILC|ANCOVA|||||||<0.001
72361489|NCT00713609|144234217|SUPERIORITY_OR_OTHER|||||||0.006||||||For TC|ANCOVA|||||||0.006
72361490|NCT00713609|144234217|SUPERIORITY_OR_OTHER|||||||0.62||||||For TC|ANCOVA|||||||0.620
72361491|NCT00713609|144234217|SUPERIORITY_OR_OTHER|||||||0.291||||||For TC|ANCOVA|||||||0.291
72361492|NCT00713609|144234217|SUPERIORITY_OR_OTHER|||||||0.085||||||For TC|ANCOVA|||||||0.085
72361493|NCT00713609|144234217|SUPERIORITY_OR_OTHER||||||<|0.001||||||For TC|ANCOVA|||||||<0.001
72361494|NCT00713609|144234218|SUPERIORITY_OR_OTHER|||||||0.652|||||||Cochran-Mantel-Haenszel|||||||0.652
72361495|NCT00713609|144234218|SUPERIORITY_OR_OTHER|||||||0.279|||||||Cochran-Mantel-Haenszel|||||||0.279
72361496|NCT00713609|144234218|SUPERIORITY_OR_OTHER|||||||0.312|||||||Cochran-Mantel-Haenszel|||||||0.312
72361497|NCT00713609|144234218|SUPERIORITY_OR_OTHER|||||||0.063|||||||Cochran-Mantel-Haenszel|||||||0.063
72361498|NCT00713609|144234218|SUPERIORITY_OR_OTHER|||||||0.005|||||||Cochran-Mantel-Haenszel|||||||0.005
72361499|NCT01903356|144234219|OTHER||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|Wilcoxon signed rank test has been used for this analysis.||Comparison of % of HbA1c before and 24 weeks after administration of TrajentaDuo® Tablet treatment.|The difference considered in the analysis is HbA1c values after drug administration minus HbA1c values before drug administration|||<0.0001
72361500|NCT01903356|144234222|OTHER||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|Wilcoxon signed rank test has been used for this analysis.||Comparison of FPG before and 24 weeks after administration of TrajentaDuo® Tablet treatment|The difference considered in the analysis is FPG values after drug administration minus FPG values before drug administration|||<0.0001
72361501|NCT04529083|144234224|OTHER||Mean Difference (Net)|-0.625||||0.011|TWO_SIDED|95.0|-1.06|-0.19|||t-test, 2 sided|||||-0.19|-1.06|0.011
72361502|NCT04529083|144234226|SUPERIORITY||Mean Difference (Net)|1.94||||0.006|TWO_SIDED|95.0|0.63|3.26|||t-test, 2 sided|||||3.26|0.63|0.006
72361503|NCT03305666|144234227|NON_INFERIORITY|Statistical analyses were conduced using SAS version 9.4. This non-inferiority test was conducted via a one-way ANOVA test, with statistical significance set at p \< 0.05.||||||0.12|||||||ANOVA|||||||0.12
72361504|NCT03305666|144234228|NON_INFERIORITY|Statistical analyses were conducted using SAS version 9.4. This non-inferiority test was conducted via a one-way ANOVA test, with statistical significance set at p \< 0.05.||||||0.41|||||||ANOVA|||This is the P-Value for between groups comparison of Postoperative Day #1.||||0.41
72361505|NCT03305666|144234228|NON_INFERIORITY|Statistical analyses were conducted using SAS version 9.4. This non-inferiority test was conducted via a one-way ANOVA test, with statistical significance set at p \< 0.05.||||||0.25|||||||ANOVA|||This is the P-Value for between groups comparison of Postoperative Day #2.||||0.25
72361506|NCT03305666|144234228|NON_INFERIORITY|Statistical analyses were conducted using SAS version 9.4. This non-inferiority test was conducted via a one-way ANOVA test, with statistical significance set at p \< 0.05.||||||0.12|||||||ANOVA|||This is the P-Value for between groups comparison of Postoperative Day #3.||||0.12
72361507|NCT03305666|144234228|NON_INFERIORITY|Statistical analyses were conducted using SAS version 9.4. This non-inferiority test was conducted via a one-way ANOVA test, with statistical significance set at p \< 0.05.||||||0.04|||||||ANOVA|||This is the P-Value for between groups comparison of Postoperative Day #4.||||0.04
72361508|NCT03305666|144234228|NON_INFERIORITY|Statistical analyses were conducted using SAS version 9.4. This non-inferiority test was conducted via a one-way ANOVA test, with statistical significance set at p \< 0.05.||||||0.32|||||||ANOVA|||This is the P-Value for between groups comparison of Postoperative Day #5.||||0.32
72361509|NCT03305666|144234229|NON_INFERIORITY|Statistical analyses were conduced using SAS version 9.4. This non-inferiority test was conducted via a one-way ANOVA test, with statistical significance set at p \< 0.05.||||||0.23|||||||ANOVA|||||||0.23
72361510|NCT02587221|144234233|OTHER|"VE=1-HR, where HR is the hazard ratio estimated by the Cox proportional hazards model for time to first occurrence of RT-PCR confirmed due to any strain.~An ILI was defined as presence of ≥1 respiratory symptom (e.g. sore throat, cough, sputum production, wheezing, or difficulty breathing) concurrently with ≥1 systemic symptom (temp \>37.2°C/99°F, chills, tiredness, headache, or myalgia) (protocol defined ILI definition)."|Vaccine efficacy (VE)|19.8|||||TWO_SIDED|97.45|-5.27|38.91|||Regression, Cox|Adjusted for covariates||The efficacy of aQIV would be demonstrated if the LL of the two-sided multiplicity adjusted 95%CI for the vaccine efficacy is \>40%||38.91|-5.27|
72361511|NCT02587221|144234238|OTHER|"VE=1-HR, where HR is the hazard ratio estimated by the Cox proportional hazards model for time to first occurrence of RT-PCR confirmed due to any strain.~An ILI was defined as the presence of fever (temperature \>37.2°C) with cough or sore throat (modified CDC ILI definition)."|Vaccine efficacy (VE)|32.12|||||TWO_SIDED|95.0|10.23|48.67|||Regression, Cox|Adjusted for covariates||||48.67|10.23|
72361512|NCT02587221|144234239|OTHER|"VE=1-HR, where HR is the hazard ratio estimated by the Cox proportional hazards model for time to first occurrence of culture confirmed influenza due to any strain of influenza antigenically matched to the vaccine strains.~An ILI was defined as the presence of ≥1 respiratory symptom (eg. sore throat, cough, sputum production, wheezing, or difficulty breathing) concurrently with ≥1 systemic symptom (temp \>37.2°C/99°F, chills, tiredness, headache, or myalgia) (protocol defined ILI definition)."|Vaccine efficacy (VE)|49.94|||||TWO_SIDED|95.0|-24.03|79.79|||Regression, Cox|Adjusted for covariates||The efficacy of aQIV would be demonstrated if the LL of the two-sided multiplicity adjusted 95%CI for the vaccine efficacy is \>40%||79.79|-24.03|
72361513|NCT02587221|144234240|OTHER|"VE=1-HR, where HR is the hazard ratio estimated by the Cox proportional hazards model for time to first occurrence of culture confirmed influenza due to any strain of influenza antigenically matched to the strains selected for the seasonal vaccine.~An ILI was defined as presence of fever (temperature \>37.2°C) with cough or sore throat (modified CDC ILI definition)."|Vaccine efficacy (VE)|61.5|||||TWO_SIDED|95.0|-7.98|86.28|||Regression, Cox|Adjusted for covariates||||86.28|-7.98|
72361514|NCT02587221|144234241|OTHER|"VE=1-HR, where HR is the hazard ratio estimated by the Cox proportional hazards model for time to first occurrence of culture confirmed influenza due to any vaccine strain regardless of antigenic match.~An ILI was defined as the presence of ≥1 respiratory symptom (e.g. sore throat, cough, sputum production, wheezing, or difficulty breathing) concurrently with ≥1 systemic symptom (temp \>37.2°C/99°F, chills, tiredness, headache, or myalgia) (protocol defined ILI definition)."|Vaccine efficacy (VE)|28.66|||||TWO_SIDED|95.0|0.05|49.08|||Regression, Cox|Adjusted for covariates||||49.08|0.05|
72361515|NCT02587221|144234242|OTHER|"VE=1-HR, where HR is the hazard ratio estimated by the Cox proportional hazards model for time to first occurrence of culture confirmed influenza due to any strain of influenza regardless of antigenic match~An ILI was defined as presence of fever (temperature \>37.2°C) with cough or sore throat (modified CDC ILI definition)."|Vaccine efficacy (VE)|33.47|||||TWO_SIDED|95.0|2.56|54.57|||Regression, Cox|Adjusted for covariates||||54.57|2.56|
72361516|NCT02587221|144234243|OTHER|"VE=1-HR, where HR is the hazard ratio estimated by the Cox proportional hazards model for time to first occurrence of culture confirmed influenza due to any strain of influenza antigenically unmatched to the vaccine strains.~An ILI is the presence of ≥1 respiratory symptom (e.g. sore throat, cough, sputum production, wheezing, or difficulty breathing) concurrently with ≥1 systemic symptom (temp \>37.2°C/99°F, chills, tiredness, headache, or myalgia) (protocol defined ILI definition)."|Vaccine efficacy (VE)|23.79|||||TWO_SIDED|95.0|-9.69|47.05|||Regression, Cox|Adjusted for covariates||||47.05|-9.69|
72361517|NCT02587221|144234244|OTHER|"VE=1-HR, where HR is the hazard ratio estimated by the Cox proportional hazards model for time to first occurrence of culture confirmed influenza due to any strain of influenza antigenically unmatched to the strains selected for the seasonal vaccine.~An ILI was defined as presence of fever (temperature \>37.2°C) with cough or sore throat (modified CDC ILI definition)."|Vaccine efficacy (VE)|26.11|||||TWO_SIDED|95.0|-11.71|51.13|||Regression, Cox|Adjusted for covariates||||51.13|-11.71|
72361518|NCT02587221|144234249|OTHER|"VE=1-HR, where HR is the hazard ratio estimated by the Cox proportional hazards model for time to first occurrence of RT-PCR confirmed due to any strain.~An ILI was defined as presence of fever (temperature ≥38°C) with cough (WHO ILI definition)."|Vaccine efficacy (VE)|51.08|||||TWO_SIDED|95.0|28.21|66.67|||Regression, Cox|Adjusted for covariates||||66.67|28.21|
72361519|NCT02587221|144234250|OTHER|"VE=1-HR, where HR is the hazard ratio estimated by the Cox proportional hazards model for time to first occurrence of culture confirmed influenza due to any strain of influenza antigenically matched to the strains selected for the seasonal vaccine.~An ILI was defined as presence of fever (temperature ≥38°C) with cough (WHO ILI definition)"|Vaccine efficacy (VE)|74.96|||||TWO_SIDED|95.0|-17.93|94.68|||Regression, Cox|Adjusted for covariates||||94.68|-17.93|
72361520|NCT02587221|144234251|OTHER|"VE=1-HR, where HR is the hazard ratio estimated by the Cox proportional hazards model for time to first occurrence of culture confirmed influenza due to any strain of influenza regardless of antigenic match.~An ILI was defined as presence of fever (temperature ≥38°C) with cough (WHO ILI definition)."|Vaccine efficacy (VE)|60.17|||||TWO_SIDED|95.0|31.19|76.94|||Regression, Cox|Adjusted for covariates||||76.94|31.19|
72361521|NCT02587221|144234252|OTHER|"VE=1-HR, where HR is the hazard ratio estimated by the Cox proportional hazards model for time to first occurrence of culture confirmed influenza due to any strain of influenza antigenically unmatched to the strains selected for the seasonal vaccine.~An ILI was defined as presence of fever (temperature ≥38°C) with cough (WHO ILI definition)."|Vaccine efficacy (VE)|57.02|||||TWO_SIDED|95.0|22.73|76.09|||Regression, Cox|Adjusted for covariates||||76.09|22.73|
72361522|NCT01791244|144234265|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.48||||0.9148|TWO_SIDED|95.0|-8.3|9.25|||linear mixed model|||Linear mixed model, with baseline value, time, Expanded Disability Status Score (EDSS) at baseline and sex as fixed factors was used for the analysis.||9.25|-8.30|0.9148
72361523|NCT02893293|144234333|OTHER|||||||0.002||||||A p-value less than the a priori threshold of 0.05 was considered statistically significant.|Mixed Models Analysis|Mixed effects model including a random effect term accounting for correlation among the measures with a same patient.||||||0.002
72361524|NCT02893293|144234334|OTHER|||||||0.02||||||A p-value less than the a priori threshold of 0.05 was considered statistically significant.|Mixed Models Analysis|Mixed effects model including a random effect term accounting for correlation among the measures with a same patient.||||||0.02
72361525|NCT00214045|144234359|SUPERIORITY_OR_OTHER|Results were analyzed using Wilcoxon rank sums and Fisher exact tests with Statistical Analysis System (SAS) statistical software version 9.||||||0.39|||||||Wilcoxon (Mann-Whitney)|||||||.39
72361526|NCT00214045|144234359|NON_INFERIORITY_OR_EQUIVALENCE|Results were analyzed using Wilcoxon rank sums and Fisher exact tests with Statistical Analysis System (SAS) statistical software version 9.||||||0.37|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.37
72361527|NCT01446159|144234379|SUPERIORITY||Hazard Ratio (HR)|0.991||||0.86|TWO_SIDED|95.0|0.689|1.429|||Log Rank|||||1.429|0.689|0.86
72361528|NCT00795535|144234408|SUPERIORITY_OR_OTHER||||||<|0.15|TWO_SIDED|||||To avoid overfitting the models, only predictors with p\<0.15 were included in the final models.|Wilcoxon (Mann-Whitney)|||Wilcoxon rank sum tests were used to compare continuous predictors, whereas chi-square tests were used to compare dichotomized predictors between those with and without serious injury. Test characteristics (specificity and positive/negative predictive values) of continuous predictors were reported based on threshold values chosen for a minimum of 80% of sensitivity. Multiple logistic regression models were used to examine the marginal effect of each predictor.||||< 0.15
72361529|NCT02485691|144234415|SUPERIORITY|A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measure are reported and continued when previous outcome measure was statistically significant at two-sided 0.05. Only the primary and the first 4 secondary outcome measures were included in the procedure.|Hazard Ratio (HR)|0.54|||<|0.0001|TWO_SIDED|95.0|0.4|0.73||P-value from 2-sided stratified log-rank test, stratified for ECOG performance status, time from AR- targeted agent initiation progression, timing of AR targeted agent as specified at the time of randomization. Significance threshold was at 0.05.|Log Rank||Cabazitaxel vs Abiraterone Acetate or Enzalutamide|Hazard ratio was estimated using a Cox Proportional Hazards regression model. The Cox proportional hazard model was stratified by ECOG performance status, time from AR- targeted agent initiation progression, timing of AR targeted agent as specified at the time of randomization.||0.73|0.40|<0.0001
72361530|NCT02485691|144234416|SUPERIORITY|A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measure are reported and continued when previous outcome measure was statistically significant at two-sided 0.05. Only the primary and the first 4 secondary outcome measures were included in the procedure.|Hazard Ratio (HR)|0.64||||0.0078|TWO_SIDED|95.0|0.46|0.89||P-value from two-sided stratified log-rank test, stratified for ECOG performance status, time from AR-targeted agent initiation to progression, timing of AR-targeted agent as specified at the time of randomization. Significance threshold = 0.05.|Log Rank||Cabazitaxel vs Abiraterone Acetate or Enzalutamide|Hazard ratio was estimated using a Cox Proportional Hazards regression model. The Cox proportional hazard model was stratified by ECOG performance status, time from AR- targeted agent initiation progression, timing of AR targeted agent as specified at the time of randomization.||0.89|0.46|0.0078
72361531|NCT02485691|144234417|SUPERIORITY|A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measure are reported and continued when previous outcome measure was statistically significant at two-sided 0.05. Only the primary and the first 4 secondary outcome measures were included in the procedure.|Hazard Ratio (HR)|0.52|||<|0.0001|TWO_SIDED|95.0|0.4|0.68||P-value from two-sided stratified log-rank test, stratified for ECOG performance status, time from AR-targeted agent initiation to progression, timing of AR-targeted agent as specified at the time of randomization. Significance threshold = 0.05.|Log Rank||Cabazitaxel vs Abiraterone Acetate or Enzalutamide|Hazard ratio was estimated using a Cox Proportional Hazards regression model. The Cox proportional hazard model was stratified by ECOG performance status, time from AR- targeted agent initiation progression, timing of AR targeted agent as specified at the time of randomization.||0.68|0.40|<0.0001
72361532|NCT02485691|144234418|SUPERIORITY|A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measure are reported and continued when previous outcome measure was statistically significant at two-sided 0.05. Only the primary and the first 4 secondary outcome measures were included in the procedure.||||||0.0003||||||Cochran-Mantel-Haenszel test stratified by ECOG performance status, time from AR-targeted agent initiation to progression, timing of AR-targeted agent as specified at the time of randomization. Significance threshold = 0.05.|Cochran-Mantel-Haenszel|||||||0.0003
72361533|NCT02485691|144234419|SUPERIORITY|A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measure are reported and continued when previous outcome measure was statistically significant at two-sided 0.05. Only the primary and the first 4 secondary outcome measures were included in the procedure.||||||0.0004||||||Cochran-Mantel-Haenszel test stratified by ECOG performance status, time from AR-targeted agent initiation to progression, timing of AR-targeted agent as specified at the time of randomization. Significance threshold = 0.05.|Cochran-Mantel-Haenszel|||||||0.0004
72361534|NCT03413891|144234461|SUPERIORITY||Risk Ratio (RR)|0.93|||=|0.72|TWO_SIDED|95.0|0.6|1.42|||Chi-squared|||||1.42|0.60|=0.72
72361535|NCT03413891|144234463|SUPERIORITY||Rate Ratio|0.76|||=|0.36|TWO_SIDED|95.0|0.42|1.37|||negative-binomial regression|||||1.37|0.42|=0.36
72361536|NCT03413891|144234464|SUPERIORITY||Rate Ratio|0.32|||=|0.03|TWO_SIDED|95.0|0.12|0.89|||negative-binomial regression|||||0.89|0.12|=0.03
72361537|NCT03413891|144234465|SUPERIORITY||Rate Ratio|0.6|||=|0.11|TWO_SIDED|95.0|0.32|1.12|||negative-binomial regression|||||1.12|0.32|=0.11
72361538|NCT03413891|144234466|SUPERIORITY||Rate Ratio|0.42|||=|0.15|TWO_SIDED|95.0|0.13|1.38|||negative-binomial regression|||||1.38|0.13|=0.15
72361539|NCT03413891|144234468|SUPERIORITY||Rate Ratio|0.57|||=|0.37|TWO_SIDED|95.0|0.17|1.91|||negative-binomial regression|||||1.91|0.17|=0.37
72361540|NCT03413891|144234469|SUPERIORITY||Risk Ratio (RR)|0.7|||=|0.66|TWO_SIDED|95.0|0.26|1.91|||Chi-squared|||||1.91|0.26|=0.66
72361541|NCT03413891|144234470|SUPERIORITY||Rate Ratio|0.4|||=|0.04|TWO_SIDED|95.0|0.16|0.98|||negative-binomial regression|||||0.98|0.16|=0.04
72361542|NCT03413891|144234471|SUPERIORITY||Rate Ratio|0.37|||<|0.01|TWO_SIDED|95.0|0.18|0.78|||negative-binomial regression|||||0.78|0.18|<0.01
72361543|NCT04905134|144234497|OTHER|||||||0.04|||||||Fisher Exact|||Flexible scope compared with the SOC scope||||0.04
72361544|NCT03563209|144234555|OTHER||||||<|0.001||||||p-value was adjusted for multiple comparisons. A priori threshold for statistical significance was set to 0.05/3 (0.0167)|Friedman|||Null hypothesis: no difference between dynamic components of elbow flexor spasticity (spasticity angle) in three different forearm positions. (Comparison groups were Spasticity angle in pronation, Spasticity angle in neutral position and Spasticity angle in supination)||||<0.001
72361545|NCT01766050|144234560|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|0.991|||||TWO_SIDED|90.0|0.898|1.093||||||||1.093|0.898|
72361546|NCT01766050|144234560|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|0.911|||||TWO_SIDED|90.0|0.83|1.0||||||||1.000|0.830|
72361547|NCT01766050|144234560|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|0.994|||||TWO_SIDED|90.0|0.885|1.116||||||||1.116|0.885|
72361548|NCT01766050|144234578|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|1.05|||||TWO_SIDED|90.0|0.976|1.13||||||AUC (0-T)||1.130|0.976|
72361549|NCT01766050|144234578|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|0.966|||||TWO_SIDED|90.0|0.889|1.049||||||AUC (0-T)||1.049|0.889|
72361550|NCT01766050|144234578|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|1.033|||||TWO_SIDED|90.0|0.95|1.123||||||AUC (0-T)||1.123|0.950|
72361551|NCT01766050|144234578|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|1.049|||||TWO_SIDED|90.0|0.975|1.127||||||AUC (INF)||1.127|0.975|
72361552|NCT01766050|144234578|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|0.968|||||TWO_SIDED|90.0|0.892|1.049||||||AUC (INF)||1.049|0.892|
72361553|NCT01766050|144234578|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|1.031|||||TWO_SIDED|90.0|0.948|1.121||||||AUC(INF)||1.121|0.948|
72361554|NCT01766050|144234579|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|0.991|||||TWO_SIDED|90.0|0.898|1.093||||||||1.093|0.898|
72361555|NCT01766050|144234579|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|0.911|||||TWO_SIDED|90.0|0.83|1.0||||||||1.000|0.830|
72361556|NCT01766050|144234579|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|0.994|||||TWO_SIDED|90.0|0.885|1.116||||||||1.116|0.885|
72361557|NCT01766050|144234580|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|1.013|||||TWO_SIDED|90.0|0.944|1.088||||||AUC (0-T)||1.088|0.944|
72361558|NCT01766050|144234580|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|1.016|||||TWO_SIDED|90.0|0.936|1.103||||||AUC (0-T)||1.103|0.936|
72361559|NCT01766050|144234580|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|1.001|||||TWO_SIDED|90.0|0.893|1.121||||||AUC (0-T)||1.121|0.893|
72361560|NCT01766050|144234580|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|1.011|||||TWO_SIDED|90.0|0.942|1.085||||||AUC (INF)||1.085|0.942|
72361561|NCT01766050|144234580|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|1.016|||||TWO_SIDED|90.0|0.938|1.101||||||AUC (INF)||1.101|0.938|
72361562|NCT01766050|144234580|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|1.002|||||TWO_SIDED|90.0|0.896|1.121||||||AUC (INF)||1.121|0.896|
72361563|NCT01766050|144234581|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|1.26|||||TWO_SIDED|90.0|1.118|1.421||||||||1.421|1.118|
72361564|NCT01766050|144234581|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|1.292|||||TWO_SIDED|90.0|1.09|1.531||||||||1.531|1.090|
72361565|NCT01766050|144234581|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|1.178|||||TWO_SIDED|90.0|0.971|1.429||||||||1.429|0.971|
72361566|NCT01766050|144234582|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|1.159|||||TWO_SIDED|90.0|1.056|1.272||||||AUC (0-T)||1.272|1.056|
72361567|NCT01766050|144234582|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|1.228|||||TWO_SIDED|90.0|1.092|1.381||||||AUC (0-T)||1.381|1.092|
72361568|NCT01766050|144234582|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|1.215|||||TWO_SIDED|90.0|1.047|1.41||||||AUC (0-T)||1.410|1.047|
72361569|NCT01766050|144234582|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|1.193|||||TWO_SIDED|90.0|1.091|1.304||||||AUC (INF)||1.304|1.091|
72361570|NCT01766050|144234582|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|1.227|||||TWO_SIDED|90.0|1.093|1.379||||||AUC (INF)||1.379|1.093|
72361571|NCT01766050|144234582|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|1.3|||||TWO_SIDED|90.0|1.141|1.482||||||AUC (INF)||1.482|1.141|
72361572|NCT01766050|144234583|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|0.863|||||TWO_SIDED|90.0|0.746|0.997||||||||0.997|0.746|
72361573|NCT01766050|144234583|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|0.922|||||TWO_SIDED|90.0|0.793|1.071||||||||1.071|0.793|
72361574|NCT01766050|144234583|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|0.856|||||TWO_SIDED|90.0|0.709|1.034||||||||1.034|0.709|
72361575|NCT01766050|144234584|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|0.915|||||TWO_SIDED|90.0|0.817|1.024||||||AUC (0-T)||1.024|0.817|
72361576|NCT01766050|144234584|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|1.003|||||TWO_SIDED|90.0|0.856|1.175||||||AUC (0-T)||1.175|0.856|
72361577|NCT01766050|144234584|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|0.963|||||TWO_SIDED|90.0|0.821|1.13||||||AUC (0-T)||1.130|0.821|
72361578|NCT01766050|144234584|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|0.877|||||TWO_SIDED|90.0|0.783|0.982||||||AUC (INF)||0.982|0.783|
72361579|NCT01766050|144234584|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|1.031|||||TWO_SIDED|90.0|0.885|1.2||||||AUC (INF)||1.200|0.885|
72361580|NCT01766050|144234584|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|1.022|||||TWO_SIDED|90.0|0.839|1.245||||||AUC (INF)||1.245|0.839|
72361581|NCT01766050|144234585|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|0.948|||||TWO_SIDED|90.0|0.88|1.021||||||||1.021|0.880|
72361582|NCT01766050|144234585|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|0.922|||||TWO_SIDED|90.0|0.857|0.993||||||||0.993|0.857|
72361583|NCT01766050|144234585|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|0.954|||||TWO_SIDED|90.0|0.885|1.028||||||||1.028|0.885|
72361584|NCT01766050|144234586|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|0.941|||||TWO_SIDED|90.0|0.874|1.013||||||AUC (0-T)||1.013|0.874|
72361585|NCT01766050|144234586|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|0.986|||||TWO_SIDED|90.0|0.902|1.076||||||AUC (0-T)||1.076|0.902|
72361586|NCT01766050|144234586|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|1.027|||||TWO_SIDED|90.0|0.942|1.12||||||AUC (0-T)||1.120|0.942|
72361587|NCT01766050|144234586|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|0.939|||||TWO_SIDED|90.0|0.868|1.017||||||AUC (INF)||1.017|0.868|
72361588|NCT01766050|144234586|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|1.002|||||TWO_SIDED|90.0|0.914|1.098||||||||1.098|0.914|
72361589|NCT01766050|144234586|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|1.036|||||TWO_SIDED|90.0|0.94|1.142||||||AUC (INF)||1.142|0.940|
72361590|NCT03577275|144234596|OTHER|||||||||||||||||"The primary analysis was based on concentration-QTc modeling of the relationship between icosabutate and delta delta QTcF, with the intent to exclude an effect \> 10 msec at clinically relevant icosabutate plasma concentrations.~Assay sensitivity was evaluated by concentration-QTc analysis of the effect on delta delta QTcF of moxifloxacin using a similar model as for the primary analysis."|The primary analysis was based on concentration-QTc modeling of the relationship between icosabutate and delta delta QTcF, with the intent to exclude an effect \> 10 msec at clinically relevant icosabutate plasma concentrations.|||
72361591|NCT02535481|144234664|SUPERIORITY|||||||0.366||||||At 6 weeks|Fisher Exact|||||||0.366
72361592|NCT02535481|144234664|SUPERIORITY|||||||0.24||||||At 3 months|Fisher Exact|||||||0.24
72361593|NCT02535481|144234665|SUPERIORITY||||||<|0.0001|||||||Log Rank|Kaplan-Meier analysis of cumulative wound healing followed by a log rank test||||||<0.0001
72361594|NCT02535481|144234666|SUPERIORITY|||||||0.12|||||||Log Rank|||||||0.12
72361595|NCT02535481|144234667|SUPERIORITY|||||||0.001|||||||t-test, 2 sided|||||||0.001
72361596|NCT02535481|144234668|SUPERIORITY|||||||0.001||||||At 6 weeks|Wilcoxon (Mann-Whitney)|||||||0.001
72361597|NCT02535481|144234668|SUPERIORITY|||||||0.001||||||At 3 months|Wilcoxon (Mann-Whitney)|||||||0.001
72361598|NCT02764385|144234670|SUPERIORITY||Odds Ratio (OR)|1.87|||||TWO_SIDED|95.0|1.73|2.01||||||||2.01|1.73|
72361599|NCT02764385|144234670|SUPERIORITY||Odds Ratio (OR)|0.68||||0.05|TWO_SIDED|95.0|0.45|1.02|||Regression, Logistic|We adjust for clustering of visit within clinician and clinical site and the stepped wedge study design using generalized estimating equation methods.||||1.02|.45|.05
72361600|NCT02764385|144234671|SUPERIORITY||Odds Ratio (OR)|1.87|||||TWO_SIDED|95.0|1.73|2.1||||||||2.10|1.73|
72361601|NCT04607668|144234676|OTHER||Mean Difference (Final Values)|-1.2|||<|0.001|TWO_SIDED|95.0|-1.7|-0.6||Two-sided p-value for treatment effect was generated from a nonparametric ANCOVA controlling for stratification factors of Region and Prior chemotherapy with study baseline ANC value as a covariate.|ANCOVA|||||-0.6|-1.7|<0.001
72361602|NCT04607668|144234677|OTHER||aRR|0.04|STANDARD_ERROR_OF_MEAN|0.032|<|0.001|TWO_SIDED|95.0|0.01|0.19|||modified Poisson model|||||0.19|0.01|<0.001
72361603|NCT02177695|144234698|SUPERIORITY||Odds Ratio (OR)|2.63||||0.1|TWO_SIDED|95.0|0.82|8.36|||Regression, Logistic|||To determine the relationship of GC COXEN scores to pT0, GC COXEN score (dichotomous, favorable vs. unfavorable) was tested in a logistic regression model predicting the outcome of pT0 within the GC treatment group.||8.36|0.82|0.1
72361604|NCT02177695|144234698|SUPERIORITY||Odds Ratio (OR)|1.12||||0.82|TWO_SIDED|95.0|0.42|2.95|||Regression, Logistic|||To determine the relationship of ddMVAC COXEN scores to pT0, ddMVAC COXEN score (dichotomous, favorable vs. unfavorable) was tested in a logistic regression model predicting the outcome of pT0 within the ddMVAC treatment group.||2.95|0.42|0.82
72361605|NCT02177695|144234699|SUPERIORITY||Odds Ratio (OR)|2.33||||0.02|TWO_SIDED|95.0|1.11|4.89|||Regression, Logistic|||To determine the relationship of GC COXEN scores to \<= pT1, GC COXEN score (dichotomous, favorable vs. unfavorable) was tested in a logistic regression model predicting the outcome of pT1 or better within the GC treatment group.||4.89|1.11|0.02
72361606|NCT02177695|144234699|SUPERIORITY||Odds Ratio (OR)|0.9||||0.76|TWO_SIDED|95.0|0.46|1.75|||Regression, Logistic|||To determine the relationship of ddMVAC COXEN scores to \<=pT1, ddMVAC COXEN score (dichotomous, favorable vs. unfavorable) was tested in a logistic regression model predicting the outcome of pT1 or better within the ddMVAC treatment group.||1.75|0.46|0.76
72361607|NCT05546476|144234732|SUPERIORITY||Difference in Posterior Median|1.33|||||TWO_SIDED|90.0|0.49|2.34||||||Bayesian Emax model was used for statistical calculation. The posterior medians and 90% credible intervals (5th and 95th percentiles of the relevant posterior distribution) were reported for differences relative to placebo). No adjustments were made for multiplicity.||2.34|0.49|
72361608|NCT05546476|144234732|SUPERIORITY||Difference in Posterior Median|2.08|||||TWO_SIDED|90.0|1.08|3.15||||||Bayesian Emax model was used for statistical calculation. The posterior medians and 90% credible intervals (5th and 95th percentiles of the relevant posterior distribution) were reported for differences relative to placebo). No adjustments were made for multiplicity.||3.15|1.08|
72361609|NCT05546476|144234732|SUPERIORITY||Difference in Posterior Median|3.0|||||TWO_SIDED|90.0|1.68|4.34||||||Bayesian Emax model was used for statistical calculation. The posterior medians and 90% credible intervals (5th and 95th percentiles of the relevant posterior distribution) were reported for differences relative to placebo). No adjustments were made for multiplicity.||4.34|1.68|
72361610|NCT05546476|144234733|SUPERIORITY||Difference in LS Mean|53.36|||=|0.826|TWO_SIDED|90.0|-40.89|147.6|||MMRM analysis; 1-sided|||Sedentary Activity Time: MMRM model included participant as a random term, and baseline, time (as a factor), baseline-by-time interaction, treatment and treatment-by-time interaction, type of therapy \[platinum or not at randomization +/- 28 days\], and type of cancer as fixed terms, with an unstructured covariance matrix and Kenwood-Roger degrees of freedom.||147.60|-40.89|=0.8260
72361611|NCT05546476|144234733|SUPERIORITY||Difference in LS Mean|-37.9|||=|0.254|TWO_SIDED|90.0|-132.94|57.14|||MMRM analysis; 1-sided|||Sedentary Activity Time: MMRM model included participant as a random term, and baseline, time (as a factor), baseline-by-time interaction, treatment and treatment-by-time interaction, type of therapy \[platinum or not at randomization +/- 28 days\], and type of cancer as fixed terms, with an unstructured covariance matrix and Kenwood-Roger degrees of freedom.||57.14|-132.94|=0.2540
72361612|NCT05546476|144234733|SUPERIORITY||Difference in LS Mean|-1.95|||=|0.487|TWO_SIDED|90.0|-101.63|97.73|||MMRM analysis; 1-sided|||Sedentary Activity Time: MMRM model included participant as a random term, and baseline, time (as a factor), baseline-by-time interaction, treatment and treatment-by-time interaction, type of therapy \[platinum or not at randomization +/- 28 days\], and type of cancer as fixed terms, with an unstructured covariance matrix and Kenwood-Roger degrees of freedom.||97.73|-101.63|=0.4870
72361613|NCT05546476|144234733|SUPERIORITY||Difference in LS Mean|37.76|||=|0.0497|TWO_SIDED|90.0|0.07|75.46|||MMRM analysis; 1-sided|||Non-Sedentary Activity Time: MMRM model included participant as a random term, and baseline, time (as a factor), baseline-by-time interaction, treatment and treatment-by-time interaction, type of therapy \[platinum or not at randomization +/- 28 days\], and type of cancer as fixed terms, with an unstructured covariance matrix and Kenwood-Roger degrees of freedom.||75.46|0.07|=0.0497
72361614|NCT05546476|144234733|SUPERIORITY||Difference in LS Mean|-4.36|||=|0.5745|TWO_SIDED|90.0|-42.94|34.22|||MMRM analysis; 1-sided|||Non-Sedentary Activity Time: MMRM model included participant as a random term, and baseline, time (as a factor), baseline-by-time interaction, treatment and treatment-by-time interaction, type of therapy \[platinum or not at randomization +/- 28 days\], and type of cancer as fixed terms, with an unstructured covariance matrix and Kenwood-Roger degrees of freedom.||34.22|-42.94|=0.5745
72361615|NCT05546476|144234733|SUPERIORITY||Difference in LS Mean|49.85|||=|0.0189|TWO_SIDED|90.0|10.62|89.08|||MMRM analysis; 1-sided|||Non-Sedentary Activity Time: MMRM model included participant as a random term, and baseline, time (as a factor), baseline-by-time interaction, treatment and treatment-by-time interaction, type of therapy \[platinum or not at randomization +/- 28 days\], and type of cancer as fixed terms, with an unstructured covariance matrix and Kenwood-Roger degrees of freedom.||89.08|10.62|=0.0189
72361616|NCT05546476|144234733|SUPERIORITY||Difference in LS Mean|8.51|||=|0.1302|TWO_SIDED|90.0|-4.0|21.03|||MMRM analysis; 1-sided|||Moderate to Vigorous Physical Activity Time: MMRM model included participant as a random term, and baseline, time (as a factor), baseline-by-time interaction, treatment and treatment-by-time interaction, type of therapy \[platinum or not at randomization +/- 28 days\], and type of cancer as fixed terms, with an unstructured covariance matrix and Kenwood-Roger degrees of freedom.||21.03|-4.00|=0.1302
72361617|NCT05546476|144234733|SUPERIORITY||Difference in LS Mean|4.49|||=|0.278|TWO_SIDED|90.0|-8.18|17.16|||MMRM analysis; 1-sided|||Moderate to Vigorous Physical Activity Time: MMRM model included participant as a random term, and baseline, time (as a factor), baseline-by-time interaction, treatment and treatment-by-time interaction, type of therapy \[platinum or not at randomization +/- 28 days\], and type of cancer as fixed terms, with an unstructured covariance matrix and Kenwood-Roger degrees of freedom.||17.16|-8.18|=0.2780
72361618|NCT05546476|144234733|SUPERIORITY||Difference in LS Mean|8.11|||=|0.1529|TWO_SIDED|90.0|-5.01|21.23|||MMRM analysis; 1-sided|||Moderate to Vigorous Physical Activity Time: MMRM model included participant as a random term, and baseline, time (as a factor), baseline-by-time interaction, treatment and treatment-by-time interaction, type of therapy \[platinum or not at randomization +/- 28 days\], and type of cancer as fixed terms, with an unstructured covariance matrix and Kenwood-Roger degrees of freedom.||21.23|-5.01|=0.1529
72361619|NCT05546476|144234734|SUPERIORITY||Difference in LS Mean|-130.27|||=|0.5762|TWO_SIDED|90.0|-1257.31|996.77|||MMRM analysis; 1-sided|||MMRM model included participant as a random term, and baseline, time (as a factor), baseline-by-time interaction, treatment and treatment-by-time interaction, type of therapy \[platinum or not at randomization +/- 28 days\], and type of cancer as fixed terms, with an unstructured covariance matrix and Kenwood-Roger degrees of freedom.||996.77|-1257.31|=0.5762
72361620|NCT05546476|144234734|SUPERIORITY||Difference in LS Mean|724.14|||=|0.1486|TWO_SIDED|90.0|-425.81|1874.09|||MMRM analysis; 1-sided|||MMRM model included participant as a random term, and baseline, time (as a factor), baseline-by-time interaction, treatment and treatment-by-time interaction, type of therapy \[platinum or not at randomization +/- 28 days\], and type of cancer as fixed terms, with an unstructured covariance matrix and Kenwood-Roger degrees of freedom.||1874.09|-425.81|=0.1486
72361621|NCT05546476|144234734|SUPERIORITY||Difference in LS Mean|185.62|||=|0.3972|TWO_SIDED|90.0|-997.94|1369.18|||MMRM analysis; 1-sided|||MMRM model included participant as a random term, and baseline, time (as a factor), baseline-by-time interaction, treatment and treatment-by-time interaction, type of therapy \[platinum or not at randomization +/- 28 days\], and type of cancer as fixed terms, with an unstructured covariance matrix and Kenwood-Roger degrees of freedom.||1369.18|-997.94|=0.3972
72361622|NCT05546476|144234735|SUPERIORITY||Difference in LS Mean|1587.26|||=|0.0985|TWO_SIDED|90.0|-443.79|3618.31|||MMRM analysis; 1-sided|||MMRM model included participant as a random term, and baseline, time (as a factor), baseline-by-time interaction, treatment and treatment-by-time interaction, type of therapy \[platinum or not at randomization +/- 28 days\], and type of cancer as fixed terms, with an unstructured covariance matrix and Kenwood-Roger degrees of freedom.||3618.31|-443.79|=0.0985
72361623|NCT05546476|144234735|SUPERIORITY||Difference in LS Mean|-98.54|||=|0.5315|TWO_SIDED|90.0|-2169.67|1972.58|||MMRM analysis; 1-sided|||MMRM model included participant as a random term, and baseline, time (as a factor), baseline-by-time interaction, treatment and treatment-by-time interaction, type of therapy \[platinum or not at randomization +/- 28 days\], and type of cancer as fixed terms, with an unstructured covariance matrix and Kenwood-Roger degrees of freedom.||1972.58|-2169.67|=0.5315
72361624|NCT05546476|144234735|SUPERIORITY||Difference in LS Mean|2203.18|||=|0.0437|TWO_SIDED|90.0|84.51|4321.85|||MMRM analysis; 1-sided|||MMRM model included participant as a random term, and baseline, time (as a factor), baseline-by-time interaction, treatment and treatment-by-time interaction, type of therapy \[platinum or not at randomization +/- 28 days\], and type of cancer as fixed terms, with an unstructured covariance matrix and Kenwood-Roger degrees of freedom.||4321.85|84.51|=0.0437
72361625|NCT05546476|144234736|SUPERIORITY||Difference in LS Mean|0.0|||=|0.5052|TWO_SIDED|90.0|-0.046|0.045|||MMRM analysis; 1-sided|||Gait Speed: MMRM model included participant as a random term, and baseline, time (as a factor), baseline-by-time interaction, treatment and treatment-by-time interaction, type of therapy \[platinum or not at randomization +/- 28 days\], and type of cancer as fixed terms, with an unstructured covariance matrix and Kenwood-Roger degrees of freedom.||0.045|-0.046|=0.5052
72361626|NCT05546476|144234736|SUPERIORITY||Difference in LS Mean|-0.004|||=|0.5599|TWO_SIDED|90.0|-0.05|0.042|||MMRM analysis; 1-sided|||Gait Speed: MMRM model included participant as a random term, and baseline, time (as a factor), baseline-by-time interaction, treatment and treatment-by-time interaction, type of therapy \[platinum or not at randomization +/- 28 days\], and type of cancer as fixed terms, with an unstructured covariance matrix and Kenwood-Roger degrees of freedom.||0.042|-0.050|=0.5599
72361627|NCT05546476|144234736|SUPERIORITY||Difference in LS Mean|0.017|||=|0.277|TWO_SIDED|90.0|-0.03|0.064|||MMRM analysis; 1-sided|||Gait Speed: MMRM model included participant as a random term, and baseline, time (as a factor), baseline-by-time interaction, treatment and treatment-by-time interaction, type of therapy \[platinum or not at randomization +/- 28 days\], and type of cancer as fixed terms, with an unstructured covariance matrix and Kenwood-Roger degrees of freedom.||0.064|-0.030|=0.2770
72361628|NCT05546476|144234736|SUPERIORITY||Difference in LS Mean|0.0|||=|0.5047|TWO_SIDED|90.0|-0.071|0.07|||MMRM analysis; 1-sided|||95th Percentile of Gait Speed: MMRM model included participant as a random term, and baseline, time (as a factor), baseline-by-time interaction, treatment and treatment-by-time interaction, type of therapy \[platinum or not at randomization +/- 28 days\], and type of cancer as fixed terms, with an unstructured covariance matrix and Kenwood-Roger degrees of freedom.||0.070|-0.071|=0.5047
72361629|NCT05546476|144234736|SUPERIORITY||Difference in LS Mean|-0.026|||=|0.7316|TWO_SIDED|90.0|-0.097|0.045|||MMRM analysis; 1-sided|||95th Percentile of Gait Speed: MMRM model included participant as a random term, and baseline, time (as a factor), baseline-by-time interaction, treatment and treatment-by-time interaction, type of therapy \[platinum or not at randomization +/- 28 days\], and type of cancer as fixed terms, with an unstructured covariance matrix and Kenwood-Roger degrees of freedom.||0.045|-0.097|=0.7316
72361630|NCT05546476|144234736|SUPERIORITY||Difference in LS Mean|0.01|||=|0.4145|TWO_SIDED|90.0|-0.063|0.082|||MMRM analysis; 1-sided|||95th Percentile of Gait Speed: MMRM model included participant as a random term, and baseline, time (as a factor), baseline-by-time interaction, treatment and treatment-by-time interaction, type of therapy \[platinum or not at randomization +/- 28 days\], and type of cancer as fixed terms, with an unstructured covariance matrix and Kenwood-Roger degrees of freedom.||0.082|-0.063|=0.4145
72361631|NCT05546476|144234737|SUPERIORITY||Difference in LS Mean|4.24|||=|0.0114|TWO_SIDED|90.0|1.19|7.28|||MMRM analysis; 1-sided|||MMRM model included participant as a random term, and baseline, time (as a factor), baseline-by-time interaction, treatment and treatment-by-time interaction, type of therapy \[platinum or not at randomization +/- 28 days\], and type of cancer as fixed terms, with an unstructured covariance matrix and Kenwood-Roger degrees of freedom.||7.28|1.19|=0.0114
72361632|NCT05546476|144234737|SUPERIORITY||Difference in LS Mean|0.64|||=|0.36|TWO_SIDED|90.0|-2.3|3.57|||MMRM analysis; 1-sided|||MMRM model included participant as a random term, and baseline, time (as a factor), baseline-by-time interaction, treatment and treatment-by-time interaction, type of therapy \[platinum or not at randomization +/- 28 days\], and type of cancer as fixed terms, with an unstructured covariance matrix and Kenwood-Roger degrees of freedom.||3.57|-2.30|=0.3600
72361633|NCT05546476|144234737|SUPERIORITY||Difference in LS Mean|4.11|||=|0.0138|TWO_SIDED|90.0|1.06|7.17|||MMRM analysis; 1-sided|||MMRM model included participant as a random term, and baseline, time (as a factor), baseline-by-time interaction, treatment and treatment-by-time interaction, type of therapy \[platinum or not at randomization +/- 28 days\], and type of cancer as fixed terms, with an unstructured covariance matrix and Kenwood-Roger degrees of freedom.||7.17|1.06|=0.0138
72361634|NCT05546476|144234738|SUPERIORITY||Difference in LS Mean|2.35|||=|0.009|TWO_SIDED|90.0|0.72|3.97|||MMRM analysis; 1-sided|||MMRM model included participant as a random term, and baseline, time (as a factor), baseline-by-time interaction, treatment and treatment-by-time interaction, type of therapy \[platinum or not at randomization +/- 28 days\], and type of cancer as fixed terms, with an unstructured covariance matrix and Kenwood-Roger degrees of freedom.||3.97|0.72|=0.0090
72361635|NCT05546476|144234738|SUPERIORITY||Difference in LS Mean|0.0|||=|0.4987|TWO_SIDED|90.0|-1.55|1.56|||MMRM analysis; 1-sided|||MMRM model included participant as a random term, and baseline, time (as a factor), baseline-by-time interaction, treatment and treatment-by-time interaction, type of therapy \[platinum or not at randomization +/- 28 days\], and type of cancer as fixed terms, with an unstructured covariance matrix and Kenwood-Roger degrees of freedom.||1.56|-1.55|=0.4987
72361636|NCT05546476|144234738|SUPERIORITY||Difference in LS Mean|2.3|||=|0.01|TWO_SIDED|90.0|0.68|3.92|||MMRM analysis; 1-sided|||MMRM model included participant as a random term, and baseline, time (as a factor), baseline-by-time interaction, treatment and treatment-by-time interaction, type of therapy \[platinum or not at randomization +/- 28 days\], and type of cancer as fixed terms, with an unstructured covariance matrix and Kenwood-Roger degrees of freedom.||3.92|0.68|=0.0100
72361637|NCT05546476|144234739|SUPERIORITY||Difference in LS Mean|0.43|||=|0.1912|TWO_SIDED|90.0|-0.38|1.24|||MMRM analysis; 1-sided|||Appetite: MMRM model included participant as a random term, and baseline, time (as a factor), baseline-by-time interaction, treatment and treatment-by-time interaction, type of therapy \[platinum or not at randomization +/- 28 days\], and type of cancer as fixed terms, with an unstructured covariance matrix and Kenwood-Roger degrees of freedom.||1.24|-0.38|=0.1912
72361638|NCT05546476|144234739|SUPERIORITY||Difference in LS Mean|0.46|||=|0.1866|TWO_SIDED|90.0|-0.39|1.3|||MMRM analysis; 1-sided|||Appetite: MMRM model included participant as a random term, and baseline, time (as a factor), baseline-by-time interaction, treatment and treatment-by-time interaction, type of therapy \[platinum or not at randomization +/- 28 days\], and type of cancer as fixed terms, with an unstructured covariance matrix and Kenwood-Roger degrees of freedom.||1.30|-0.39|=0.1866
72361639|NCT05546476|144234739|SUPERIORITY||Difference in LS Mean|0.92|||=|0.0349|TWO_SIDED|90.0|0.09|1.75|||MMRM analysis; 1-sided|||Appetite: MMRM model included participant as a random term, and baseline, time (as a factor), baseline-by-time interaction, treatment and treatment-by-time interaction, type of therapy \[platinum or not at randomization +/- 28 days\], and type of cancer as fixed terms, with an unstructured covariance matrix and Kenwood-Roger degrees of freedom.||1.75|0.09|=0.0349
72361640|NCT05546476|144234739|SUPERIORITY||Difference in LS Mean|0.47|||=|0.8754|TWO_SIDED|90.0|-0.2|1.14|||MMRM analysis; 1-sided|||Nausea: MMRM model included participant as a random term, and baseline, time (as a factor), baseline-by-time interaction, treatment and treatment-by-time interaction, type of therapy \[platinum or not at randomization +/- 28 days\], and type of cancer as fixed terms, with an unstructured covariance matrix and Kenwood-Roger degrees of freedom.||1.14|-0.20|=0.8754
72361641|NCT05546476|144234739|SUPERIORITY||Difference in LS Mean|0.38|||=|0.8205|TWO_SIDED|90.0|-0.31|1.08|||MMRM analysis; 1-sided|||Nausea: MMRM model included participant as a random term, and baseline, time (as a factor), baseline-by-time interaction, treatment and treatment-by-time interaction, type of therapy \[platinum or not at randomization +/- 28 days\], and type of cancer as fixed terms, with an unstructured covariance matrix and Kenwood-Roger degrees of freedom.||1.08|-0.31|=0.8205
72361642|NCT05546476|144234739|SUPERIORITY||Difference in LS Mean|-0.17|||=|0.3375|TWO_SIDED|90.0|-0.86|0.51|||MMRM analysis; 1-sided|||Nausea: MMRM model included participant as a random term, and baseline, time (as a factor), baseline-by-time interaction, treatment and treatment-by-time interaction, type of therapy \[platinum or not at randomization +/- 28 days\], and type of cancer as fixed terms, with an unstructured covariance matrix and Kenwood-Roger degrees of freedom.||0.51|-0.86|=0.3375
72361643|NCT05546476|144234739|SUPERIORITY||Difference in LS Mean|0.66|||=|0.9138|TWO_SIDED|90.0|-0.14|1.45|||MMRM analysis; 1-sided|||Physical Fatigue: MMRM model included participant as a random term, and baseline, time (as a factor), baseline-by-time interaction, treatment and treatment-by-time interaction, type of therapy \[platinum or not at randomization +/- 28 days\], and type of cancer as fixed terms, with an unstructured covariance matrix and Kenwood-Roger degrees of freedom.||1.45|-0.14|=0.9138
72361644|NCT05546476|144234739|SUPERIORITY||Difference in LS Mean|0.64|||=|0.9011|TWO_SIDED|90.0|-0.18|1.46|||MMRM analysis; 1-sided|||Physical Fatigue: MMRM model included participant as a random term, and baseline, time (as a factor), baseline-by-time interaction, treatment and treatment-by-time interaction, type of therapy \[platinum or not at randomization +/- 28 days\], and type of cancer as fixed terms, with an unstructured covariance matrix and Kenwood-Roger degrees of freedom.||1.46|-0.18|=0.9011
72361645|NCT05546476|144234739|SUPERIORITY||Difference in LS Mean|0.21|||=|0.6618|TWO_SIDED|90.0|-0.61|1.02|||MMRM analysis; 1-sided|||Physical Fatigue: MMRM model included participant as a random term, and baseline, time (as a factor), baseline-by-time interaction, treatment and treatment-by-time interaction, type of therapy \[platinum or not at randomization +/- 28 days\], and type of cancer as fixed terms, with an unstructured covariance matrix and Kenwood-Roger degrees of freedom.||1.02|-0.61|=0.6618
72361646|NCT04196686|144234769|OTHER||Hazard Ratio (HR)|0.36|||<|0.001|TWO_SIDED|95.0|0.25|0.51|||Cox mixed effects model|||||0.51|0.25|<0.001
72361647|NCT04196686|144234770|OTHER||Mean Difference (Net)|0.455||||0.2|TWO_SIDED|95.0|0.32|0.59|||Linear mixed effects model|||Analysis was controlled for dominant hand treatment assignment, dominant hand order, and gender. Overall mean difference calculated from regression model.||0.59|0.32|0.200
72361648|NCT04196686|144234771|OTHER||Mean Difference (Net)|0.002||||0.047|TWO_SIDED|95.0|0.00007|0.00368|||Linear mixed effects model|||The variables in the physiologic model were SCRD change over time and the SCRD change between groups, defined as those with and without VR.||0.00368|0.00007|0.047
72361649|NCT02135861|144234775|OTHER||Mean Difference (Final Values)|0.16||||0.0029|TWO_SIDED|95.0|0.06|0.26||estimates of total lung|ANOVA||||Ve was fitted using a repeat measure ANOVA model with terms including participant population (HF or HV), visit (i.e. sessions), interaction of participant population and visit, with participant ID as block of the repeat factor|0.2600|0.0600|0.0029
72361650|NCT02135861|144234775|OTHER||Mean Difference (Final Values)|0.1825||||0.0007|TWO_SIDED|95.0|0.0855|0.2795||estimates of left lung|ANOVA||||Ve was fitted using a repeat measure ANOVA model with terms including participant population (HF or HV), visit (i.e. sessions), interaction of participant population and visit, with participant ID as block of the repeat factor|0.2795|0.0855|0.0007
72361651|NCT02135861|144234775|OTHER||Mean Difference (Final Values)|0.1565||||0.0093|TWO_SIDED|95.0|0.0419|0.2711||estimates of right lung|ANOVA||||Ve was fitted using a repeat measure ANOVA model with terms including participant population (HF or HV), visit (i.e. sessions), interaction of participant population and visit, with participant ID as block of the repeat factor|0.2711|0.0419|0.0093
72361652|NCT02135861|144234775|OTHER||Mean Difference (Final Values)|0.1764||||0.0007|TWO_SIDED|95.0|0.0823|0.2704||estimates of left lung apical|ANOVA||||Ve was fitted using a repeat measure ANOVA model with terms including participant population (HF or HV), visit (i.e. sessions), interaction of participant population and visit, with participant ID as block of the repeat factor|0.2704|0.0823|0.0007
72361653|NCT02135861|144234775|OTHER||Mean Difference (Final Values)|0.1999||||0.001|TWO_SIDED|95.0|0.0894|0.3103||estimates of left lung basal|ANOVA||||Ve was fitted using a repeat measure ANOVA model with terms including participant population (HF or HV), visit (i.e. sessions), interaction of participant population and visit, with participant ID as block of the repeat factor|0.3103|0.0894|0.0010
72361654|NCT02135861|144234775|OTHER||Mean Difference (Final Values)|0.136||||0.0159|TWO_SIDED|95.0|0.0276|0.2443||estimates of right lung apical|ANOVA||||Ve was fitted using a repeat measure ANOVA model with terms including participant population (HF or HV), visit (i.e. sessions), interaction of participant population and visit, with participant ID as block of the repeat factor|0.2443|0.0276|0.0159
72361655|NCT02135861|144234775|OTHER||Mean Difference (Final Values)|0.1748||||0.0064|TWO_SIDED|95.0|0.0535|0.2961||estimates of right lung basal|ANOVA||||Ve was fitted using a repeat measure ANOVA model with terms including participant population (HF or HV), visit (i.e. sessions), interaction of participant population and visit, with participant ID as block of the repeat factor|0.2961|0.0535|0.0064
72361656|NCT02135861|144234776|OTHER||Mean Difference (Final Values)|-0.0137||||0.7381|TWO_SIDED|95.0|-0.0968|0.0695||estimates of total lung|ANOVA||||Ktrans was fitted using a repeat measure ANOVA model with terms including participant population (HF or HV), visit (i.e. sessions), interaction of participant population and visit, with participant ID as block of the repeat factor|0.0695|-0.0968|0.7381
72361657|NCT02135861|144234776|OTHER||Mean Difference (Final Values)|0.0136||||0.6992|TWO_SIDED|95.0|-0.058|0.0852||estimates of left lung|ANOVA||||Ktrans was fitted using a repeat measure ANOVA model with terms including participant population (HF or HV), visit (i.e. sessions), interaction of participant population and visit, with participant ID as block of the repeat factor|0.0852|-0.0580|0.6992
72361658|NCT02135861|144234776|OTHER||Mean Difference (Final Values)|-0.0258||||0.5778|TWO_SIDED|95.0|-0.1201|0.0684||estimates of right lung|ANOVA||||Ktrans was fitted using a repeat measure ANOVA model with terms including participant population (HF or HV), visit (i.e. sessions), interaction of participant population and visit, with participant ID as block of the repeat factor|0.0684|-0.1201|0.5778
72361659|NCT02135861|144234776|OTHER||Mean Difference (Final Values)|0.0005||||0.9899|TWO_SIDED|95.0|-0.0738|0.0747||estimates of left lung apical|ANOVA||||Ktrans was fitted using a repeat measure ANOVA model with terms including participant population (HF or HV), visit (i.e. sessions), interaction of participant population and visit, with participant ID as block of the repeat factor|0.0747|-0.0738|0.9899
72361660|NCT02135861|144234776|OTHER||Mean Difference (Final Values)|0.0396||||0.2912|TWO_SIDED|95.0|-0.036|0.1153||estimates of left lung basal|ANOVA||||Ktrans was fitted using a repeat measure ANOVA model with terms including participant population (HF or HV), visit (i.e. sessions), interaction of participant population and visit, with participant ID as block of the repeat factor|0.1153|-0.0360|0.2912
72361661|NCT02135861|144234776|OTHER||Mean Difference (Final Values)|-0.0362||||0.4592|TWO_SIDED|95.0|-0.1355|0.0631||estimates of right lung apical|ANOVA||||Ktrans was fitted using a repeat measure ANOVA model with terms including participant population (HF or HV), visit (i.e. sessions), interaction of participant population and visit, with participant ID as block of the repeat factor|0.0631|-0.1355|0.4592
72361662|NCT02135861|144234776|OTHER||Mean Difference (Final Values)|-0.0118||||0.7936|TWO_SIDED|95.0|-0.1036|0.08||estimates of right lung basal|ANOVA||||Ktrans was fitted using a repeat measure ANOVA model with terms including participant population (HF or HV), visit (i.e. sessions), interaction of participant population and visit, with participant ID as block of the repeat factor|0.0800|-0.1036|0.7936
72361663|NCT02135861|144234777|OTHER||Mean Difference (Final Values)|0.1148||||0.0156|TWO_SIDED|95.0|0.0236|0.2061||estimates of total lung- Pre-exercise|ANOVA||||Ve was fitted using a repeat measure ANOVA model with terms including participant population (HF or HV), visit (i.e. sessions), interaction of participant population and visit, with participant ID as block of the repeat factor|0.2061|0.0236|0.0156
72361664|NCT02135861|144234777|OTHER||Mean Difference (Final Values)|0.1366||||0.0026|TWO_SIDED|95.0|0.0523|0.2209||estimates of left lung- Pre-exercise|ANOVA|estimates of left lung- Pre-exercise|||Ve was fitted using a repeat measure ANOVA model with terms including participant population (HF or HV), visit (i.e. sessions), interaction of participant population and visit, with participant ID as block of the repeat factor|0.2209|0.0523|0.0026
72361665|NCT02135861|144234777|OTHER||Mean Difference (Final Values)|0.1067||||0.0328|TWO_SIDED|95.0|0.0094|0.204||estimates of right lung- Pre-exercise|ANOVA||||Ve was fitted using a repeat measure ANOVA model with terms including participant population (HF or HV), visit (i.e. sessions), interaction of participant population and visit, with participant ID as block of the repeat factor|0.2040|0.0094|0.0328
72361666|NCT02135861|144234777|OTHER||Mean Difference (Final Values)|0.1145||||0.0158|TWO_SIDED|95.0|0.0235|0.2056||estimates of left lung apical-Pre-exercise|ANOVA||||Ve was fitted using a repeat measure ANOVA model with terms including participant population (HF or HV), visit (i.e. sessions), interaction of participant population and visit, with participant ID as block of the repeat factor|0.2056|0.0235|0.0158
72361667|NCT02135861|144234777|OTHER||Mean Difference (Final Values)|0.1776||||0.0002|TWO_SIDED|95.0|0.0917|0.2635||estimates of left lung basal-Pre-exercise|ANOVA||||Ve was fitted using a repeat measure ANOVA model with terms including participant population (HF or HV), visit (i.e. sessions), interaction of participant population and visit, with participant ID as block of the repeat factor|0.2635|0.0917|0.0002
72361668|NCT02135861|144234777|OTHER||Mean Difference (Final Values)|0.0956||||0.0658|TWO_SIDED|95.0|-0.0067|0.1979||estimates of right lung apical-Pre-exercise|ANOVA||||Ve was fitted using a repeat measure ANOVA model with terms including participant population (HF or HV), visit (i.e. sessions), interaction of participant population and visit, with participant ID as block of the repeat factor|0.1979|-0.0067|0.0658
72361669|NCT02135861|144234777|OTHER||Mean Difference (Final Values)|0.1194||||0.015|TWO_SIDED|95.0|0.0251|0.2137||estimates of right lung basal-Pre-exercise|ANOVA||||Ve was fitted using a repeat measure ANOVA model with terms including participant population (HF or HV), visit (i.e. sessions), interaction of participant population and visit, with participant ID as block of the repeat factor|0.2137|0.0251|0.0150
72361670|NCT02135861|144234777|OTHER||Mean Difference (Final Values)|0.1428||||0.0015|TWO_SIDED|95.0|0.0598|0.2259||estimates of total lung-Post-exercise|ANOVA||||Ve was fitted using a repeat measure ANOVA model with terms including participant population (HF or HV), visit (i.e. sessions), interaction of participant population and visit, with participant ID as block of the repeat factor|0.2259|0.0598|0.0015
72361671|NCT02135861|144234777|OTHER||Mean Difference (Final Values)|0.1776|||<|0.0001|TWO_SIDED|95.0|0.1057|0.2496||estimates of left lung-Post-exercise|ANOVA||||Ve was fitted using a repeat measure ANOVA model with terms including participant population (HF or HV), visit (i.e. sessions), interaction of participant population and visit, with participant ID as block of the repeat factor|0.2496|0.1057|<.0001
72361672|NCT02135861|144234777|OTHER||Mean Difference (Final Values)|0.126||||0.0114|TWO_SIDED|95.0|0.0308|0.2212||estimates of right lung-Post-exercise|ANOVA||||Ve was fitted using a repeat measure ANOVA model with terms including participant population (HF or HV), visit (i.e. sessions), interaction of participant population and visit, with participant ID as block of the repeat factor|0.2212|0.0308|0.0114
72361673|NCT02135861|144234777|OTHER||Mean Difference (Final Values)|0.1464||||0.0002|TWO_SIDED|95.0|0.0774|0.2153||estimates of left lung apical-Post-exercise|ANOVA||||Ve was fitted using a repeat measure ANOVA model with terms including participant population (HF or HV), visit (i.e. sessions), interaction of participant population and visit, with participant ID as block of the repeat factor|0.2153|0.0774|0.0002
72361674|NCT02135861|144234777|OTHER||Mean Difference (Final Values)|0.2137|||<|0.0001|TWO_SIDED|95.0|0.1266|0.3008||estimates of left lung basal-Post-exercise|ANOVA||||Ve was fitted using a repeat measure ANOVA model with terms including participant population (HF or HV), visit (i.e. sessions), interaction of participant population and visit, with participant ID as block of the repeat factor|0.3008|0.1266|<.0001
72361675|NCT02135861|144234777|OTHER||Mean Difference (Final Values)|0.1111||||0.025|TWO_SIDED|95.0|0.0151|0.2071||estimates of right lung apical-Post-exercise|ANOVA||||Ve was fitted using a repeat measure ANOVA model with terms including participant population (HF or HV), visit (i.e. sessions), interaction of participant population and visit, with participant ID as block of the repeat factor|0.2071|0.0151|0.0250
72361676|NCT02135861|144234777|OTHER||Mean Difference (Final Values)|0.1458||||0.0052||95.0|0.0475|0.2442||estimates of right lung basal-Post-exercise|ANOVA||||Ve was fitted using a repeat measure ANOVA model with terms including participant population (HF or HV), visit (i.e. sessions), interaction of participant population and visit, with participant ID as block of the repeat factor|0.2442|0.0475|0.0052
72361677|NCT02135861|144234778|OTHER||Mean Difference (Final Values)|-0.0524||||0.173|TWO_SIDED|95.0|-0.1292|0.0244||estimates of total lung-Pre-exercise|ANOVA||||Ktrans was fitted using a repeat measure ANOVA model with terms including participant population (HF or HV), visit (i.e. sessions), interaction of participant population and visit, with participant ID as block of the repeat factor|0.0244|-0.1292|0.1730
72361678|NCT02135861|144234778|OTHER||Mean Difference (Final Values)|-0.0423||||0.2704|TWO_SIDED|95.0|-0.1196|0.0349||estimates of left lung-Pre-exercise|ANOVA||||Ktrans was fitted using a repeat measure ANOVA model with terms including participant population (HF or HV), visit (i.e. sessions), interaction of participant population and visit, with participant ID as block of the repeat factor|0.0349|-0.1196|0.2704
72361679|NCT02135861|144234778|OTHER||Mean Difference (Final Values)|-0.0515||||0.2072|TWO_SIDED|95.0|-0.1334|0.0303||estimates of right lung-Pre-exercise|ANOVA||||Ktrans was fitted using a repeat measure ANOVA model with terms including participant population (HF or HV), visit (i.e. sessions), interaction of participant population and visit, with participant ID as block of the repeat factor|0.0303|-0.1334|0.2072
72361680|NCT02135861|144234778|OTHER||Mean Difference (Final Values)|-0.0603||||0.1307|TWO_SIDED|95.0|-0.1398|0.0191||estimates of left lung apical-Pre-exercise|ANOVA||||Ktrans was fitted using a repeat measure ANOVA model with terms including participant population (HF or HV), visit (i.e. sessions), interaction of participant population and visit, with participant ID as block of the repeat factor|0.0191|-0.1398|0.1307
72361681|NCT02135861|144234778|OTHER||Mean Difference (Final Values)|-0.0078||||0.8427|TWO_SIDED|95.0|-0.0879|0.0722||estimates of left lung basal-Pre-exercise|ANOVA||||Ktrans was fitted using a repeat measure ANOVA model with terms including participant population (HF or HV), visit (i.e. sessions), interaction of participant population and visit, with participant ID as block of the repeat factor|0.0722|-0.0879|0.8427
72361682|NCT02135861|144234778|OTHER||Mean Difference (Final Values)|-0.0506||||0.1848|TWO_SIDED|95.0|-0.1269|0.0257||estimates of right lung apical-Pre-exercise|ANOVA||||Ktrans was fitted using a repeat measure ANOVA model with terms including participant population (HF or HV), visit (i.e. sessions), interaction of participant population and visit, with participant ID as block of the repeat factor|0.0257|-0.1269|0.1848
72361683|NCT02135861|144234778|OTHER||Mean Difference (Final Values)|-0.0413||||0.3408|TWO_SIDED|95.0|-0.1286|0.0461||estimates of right lung basal-Pre-exercise|ANOVA||||Ktrans was fitted using a repeat measure ANOVA model with terms including participant population (HF or HV), visit (i.e. sessions), interaction of participant population and visit, with participant ID as block of the repeat factor|0.0461|-0.1286|0.3408
72361684|NCT02135861|144234778|OTHER||Mean Difference (Final Values)|-0.0267||||0.3682|TWO_SIDED|95.0|-0.0866|0.0332||estimates of total lung-Post-excercise|ANOVA||||Ktrans was fitted using a repeat measure ANOVA model with terms including participant population (HF or HV), visit (i.e. sessions), interaction of participant population and visit, with participant ID as block of the repeat factor|0.0332|-0.0866|0.3682
72361685|NCT02135861|144234778|OTHER||Mean Difference (Net)|-0.0201||||0.4531|TWO_SIDED|95.0|-0.0744|0.0342||estimates of left lung-Post-excercise|ANOVA||||Ktrans was fitted using a repeat measure ANOVA model with terms including participant population (HF or HV), visit (i.e. sessions), interaction of participant population and visit, with participant ID as block of the repeat factor|0.0342|-0.0744|0.4531
72361686|NCT02135861|144234778|OTHER||Mean Difference (Final Values)|-0.0188||||0.597|TWO_SIDED|95.0|-0.0909|0.0533||estimates of right lung-Post-excercise|ANOVA||||Ktrans was fitted using a repeat measure ANOVA model with terms including participant population (HF or HV), visit (i.e. sessions), interaction of participant population and visit, with participant ID as block of the repeat factor|0.0533|-0.0909|0.5970
72361687|NCT02135861|144234778|OTHER||Mean Difference (Final Values)|-0.0159||||0.5472|TWO_SIDED|95.0|-0.0693|0.0375||estimates of left lung apical-Post-excercise|ANOVA||||Ktrans was fitted using a repeat measure ANOVA model with terms including participant population (HF or HV), visit (i.e. sessions), interaction of participant population and visit, with participant ID as block of the repeat factor|0.0375|-0.0693|0.5472
72361688|NCT02135861|144234778|OTHER||Mean Difference (Final Values)|-0.0125||||0.6793|TWO_SIDED|95.0|-0.0742|0.0491||estimates of left lung basal-Post-excercise|ANOVA||||Ktrans was fitted using a repeat measure ANOVA model with terms including participant population (HF or HV), visit (i.e. sessions), interaction of participant population and visit, with participant ID as block of the repeat factor|0.0491|-0.0742|0.6793
72361689|NCT02135861|144234778|OTHER||Mean Difference (Final Values)|-0.0249||||0.4806|TWO_SIDED|95.0|-0.0964|0.0466||estimates of right lung apical-Post-excercise|ANOVA||||Ktrans was fitted using a repeat measure ANOVA model with terms including participant population (HF or HV), visit (i.e. sessions), interaction of participant population and visit, with participant ID as block of the repeat factor|0.0466|-0.0964|0.4806
72361690|NCT02135861|144234778|OTHER||Mean Difference (Final Values)|-0.0029||||0.9379|TWO_SIDED|95.0|-0.0789|0.0731||estimates of right lung basal-Post-excercise|ANOVA||||Ktrans was fitted using a repeat measure ANOVA model with terms including participant population (HF or HV), visit (i.e. sessions), interaction of participant population and visit, with participant ID as block of the repeat factor|0.0731|-0.0789|0.9379
72361691|NCT02212015|144234786|OTHER||Rate|0.46|||||TWO_SIDED|||||||||Question is, if 6 months progression free survival rate (PFS-R) denoted by pPFS is higher than 35%. Test hypothesis is thus formulated as: H0: pPFS ≤0.35 versus H1: pPFS ≥0.35. This hypothesis is tested at the one-side significance level of 0.05. A 6 months PFS-R of 0.55 of cases or more is considered as clinically relevant success rate. The design is chosen such that rates of 0.55 or higher can be detected with a power of at least 0.8.||||
72361692|NCT02212015|144234787|SUPERIORITY||Rate difference|0.486|||||TWO_SIDED|||||||||||||
72361693|NCT02212015|144234788|SUPERIORITY||Rate difference|0.0|||||TWO_SIDED|||||||||||||
72361694|NCT02212015|144234789|OTHER||Median|21.6|||||TWO_SIDED|||||||||"The analysis of secondary endpoints is of descriptive nature and generally consists of summary statistics and interval estimation.~Overall survival (OS) was defined as the time of start of treatment until death (event status=1) or last contact (censoring, event status=0). OS was analyzed using Kaplan-Meier curves. Median survival time is provided alonsgside two-sided 95% confidence interval (CI), if possible."||||
72361695|NCT02212015|144234790|SUPERIORITY|||||||0.752|||||||Log Rank|||"The analysis of secondary endpoints is of descriptive nature and generally consists of summary statistics and interval estimation.~Overall survival (OS) for subgroup 1 was defined as the time of start of treatment until death (event status=1) or last contact (censoring, event status=0). OS was analyzed using Kaplan-Meier curves. Median survival time is provided alonsgside two-sided 95% confidence interval (CI), if possible."||||0.752
72361696|NCT02212015|144234791|SUPERIORITY|||||||0.621|||||||Log Rank|||"The analysis of secondary endpoints is of descriptive nature and generally consists of summary statistics and interval estimation.~Overall survival (OS) for subgroup 2 was defined as the time of start of treatment until death (event status=1) or last contact (censoring, event status=0). OS was analyzed using Kaplan-Meier curves. Median survival time is provided alonsgside two-sided 95% confidence interval (CI), if possible."||||0.621
72361697|NCT02212015|144234792|OTHER||||||||||||||||||Frequency of each category is given|||
72361698|NCT02212015|144234793|SUPERIORITY|||||||0.349|||||||Chi squared test, exact|||Response Rate (RR) is given as Best Overall Response (BOR) and given be absolute and relative frequencies. Categories of BOR are CR, PR, SD, PD and NE)|Response Rate (RR) is given as Best Overall Response (BOR) and given be absolute and relative frequencies applied to the total of 26 enrolled subjects.. Categories of BOR are CR, PR, SD, PD and NE).|||0.349
72361699|NCT02212015|144234794|SUPERIORITY|||||||0.385|||||||Chi squared test, exact|||||||0.385
72361700|NCT03448406|144234858|SUPERIORITY||Median difference (HL-estimate)|4.0||||0.366|TWO_SIDED|95.0|-5.0|13.0|||Wilcoxon rank test, normal approximation||Empagliflozin vs. Placebo. For estimation of effect, the non-parametric Hodge-Lehman (HL) estimate for the median difference was calculated.|H0: There is no difference between the effect of Placebo and the effect of empagliflozin.||13.0|-5.0|0.3660
72361701|NCT03448406|144234859|SUPERIORITY||Median difference (HL-estimate)|2.08||||0.2783|TWO_SIDED|95.0|-2.08|6.25|||Wilcoxon rank test, normal approximation||Empagliflozin vs. Placebo. For estimation of effect, the non-parametric Hodges-Lehmann estimate for the median difference was calculated.|H0: There is no difference between the effect of Placebo and the effect of empagliflozin.||6.25|-2.08|0.2783
72361702|NCT03448406|144234860|SUPERIORITY||Median difference (HL-estimate)|-0.07||||0.5512|TWO_SIDED|95.0|-0.35|0.2|||Wilcoxon rank test, normal approximation||Empagliflozin vs. Placebo. For estimation of effect, the non-parametric Hodges-Lehmann (HL) estimate for the median difference was calculated.|H0: There is no difference between the effect of Placebo and the effect of empagliflozin.||0.20|-0.35|0.5512
72361703|NCT03448406|144234861|SUPERIORITY||Median Difference (HL-estimate)|3.0||||0.3657|TWO_SIDED|95.0|-4.0|11.0|||Wilcoxon rank test, normal approximation||Empagliflozin vs. Placebo. For estimation of effect, the non-parametric Hodges-Lehmann (HL) estimate for the median difference was calculated.|H0: There is no difference between the effect of Placebo and the effect of empagliflozin.||11.0|-4.0|0.3657
72361704|NCT03448406|144234862|OTHER||Difference of adjusted mean|-0.09|STANDARD_DEVIATION|0.11||0.444|TWO_SIDED|95.0|-0.31|0.14|||Mixed Model Repeated Measure (MMRM)|Covariates: visit-by-treatment interaction, baseline-by-visit interaction. Unstructured covariance structure was used to model within-patient errors.||||0.14|-0.31|0.4440
72361705|NCT03448406|144234863|OTHER|||||||0.3924|||||||Cochran-Mantel-Haenszel test|Test on difference in mean treatment scores, based on modified ridit scores.||||||0.3924
72361706|NCT03448406|144234864|OTHER|||||||0.4435|||||||Cochran-Mantel-Haenszel test|Test on difference in mean treatment scores, based on modified ridit scores.||||||0.4435
72361707|NCT03448406|144234865|OTHER|||||||0.5124|||||||Cochran-Mantel-Haenszel test|Test on difference in mean treatment scores, based on modified ridit scores.||||||0.5124
72361708|NCT03448406|144234866|OTHER|||||||0.5713|||||||Cochran-Mantel-Haenszel test|Test on difference in mean treatment scores, based on modified ridit scores.||||||0.5713
72361709|NCT03448406|144234867|OTHER||Adjusted geometric mean ratio|0.95||||0.4032|TWO_SIDED|95.0|0.85|1.07|||Mixed model repeated Measure (MMRM)|Covariates: Visit-by-treatment interaction and baseline-by-visit interaction. Unstructured covariance structure to model within-patient errors.|Adjusted geometric mean ratio \[Empagliflozin/Placebo\] of relative change to baseline.|||1.07|0.85|0.4032
72361710|NCT03186209|144234885|SUPERIORITY||Rate Ratio|0.26|||<|0.0001|TWO_SIDED|95.0|0.19|0.36||Multiplicity protected by hierarchy testing procedure. First in line hypothesis testing, requiring p-value \<0.05.|Negative binomial|Model with covariates: treatment group, region (China/Non-China), number of exacerbations in previous year, use of maintenance oral corticosteroids||||0.36|0.19|<0.0001
72361711|NCT03186209|144234886|SUPERIORITY||Mean Difference (Final Values)|0.25|||<|0.0001|TWO_SIDED|95.0|0.17|0.34||Test after significant primary endpoint. Two secondary endpoints (change in FEV1 and total asthma symptom score) using Holm's procedure; smaller p-value to be \<0.025, and larger p-value to be \<0.05.|Mixed Models Analysis|Model includes Treatment, baseline pre-bronchodilator FEV1, region, use of maintenance oral corticosteroids, visit, and treatment by visit||||0.34|0.17|<0.0001
72361712|NCT03186209|144234887|SUPERIORITY||Mean Difference (Final Values)|-0.25||||0.0126|TWO_SIDED|95.0|-0.45|-0.05||Test after significant primary endpoint. Two secondary endpoints (change in FEV1 and total asthma symptom score) using Holm's procedure; smaller p-value to be \<0.025, and larger p-value to be \<0.05.|Mixed Models Analysis|Model includes Treatment, baseline total asthma symptom score, region, use of maintenance oral corticosteroids, visit, and treatment by visit||||-0.05|-0.45|0.0126
72361713|NCT03186209|144234888|SUPERIORITY||Mean Difference (Final Values)|-0.17||||0.1835|TWO_SIDED|95.0|-0.42|0.08||Nominal p-value. Not multiplicity protected by testing procedure.|Mixed Models Analysis|Model includes Treatment, baseline total asthma rescue medication use, region, use of maintenance oral corticosteroids, visit, treatment\*visit||||0.08|-0.42|0.1835
72361714|NCT03186209|144234889|SUPERIORITY||Mean Difference (Final Values)|38.66|||<|0.0001|TWO_SIDED|95.0|24.24|53.07||Nominal p-value. Not multiplicity protected by testing procedure.|Mixed Models Analysis|Model includes Treatment, baseline morning PEF, region, use of maintenance oral corticosteroids, visit, and treatment by visit||||53.07|24.24|<0.0001
72361715|NCT03186209|144234890|SUPERIORITY||Mean Difference (Final Values)|35.85|||<|0.0001|TWO_SIDED|95.0|21.52|50.18||Nominal p-value. Not multiplicity protected by testing procedure.|Mixed Models Analysis|Model includes Treatment, baseline evening PEF, region, use of maintenance oral corticosteroids, visit, and treatment by visit||||50.18|21.52|<0.0001
72361716|NCT03186209|144234891|SUPERIORITY||Mean Difference (Final Values)|-0.01||||0.3385|TWO_SIDED|95.0|-0.03|0.01||Nominal p-value. Not multiplicity protected by testing procedure.|Mixed Models Analysis|Model includes Treatment, baseline proportion of nights awakening, region, use of maintenance oral corticosteroids, visit, and treatment by visit||||0.01|-0.03|0.3385
72361717|NCT03186209|144234892|SUPERIORITY||Mean Difference (Final Values)|-0.43|||<|0.0001|TWO_SIDED|95.0|-0.58|-0.28||Nominal p-value. Not multiplicity protected by testing procedure.|Mixed Models Analysis|Model includes Treatment, baseline ACQ-6 score, use of maintenance oral corticosteroids, visit, and treatment by visit||||-0.28|-0.58|<0.0001
72361718|NCT03186209|144234893|SUPERIORITY||Hazard Ratio (HR)|0.32|||<|0.0001|TWO_SIDED|95.0|0.23|0.43||Nominal p-value. Not multiplicity protected by testing procedure.|Regression, Cox|model including covariates treatment group, region, number of exacerbations in the previous year, and use of maintenance oral corticosteroids||||0.43|0.23|<0.0001
72361719|NCT03186209|144234894|SUPERIORITY||Odds Ratio (OR)|0.28|||<|0.0001|TWO_SIDED|95.0|0.19|0.42||Nominal p-value. Not multiplicity protected by testing procedure.|Cochran-Mantel-Haenszel|Controlling for region, number of exacerbations in the previous year (2, \>=3), use of OCS||||0.42|0.19|<0.0001
72361720|NCT03186209|144234895|SUPERIORITY||Mean Difference (Final Values)|-9.19|||<|0.0001|TWO_SIDED|95.0|-12.79|-5.6||Nominal p-value. Not multiplicity protected by testing procedure.|Mixed Models Analysis|Model with covariates: treatment group, baseline SGRQ total score, region, use of maintenance oral corticosteroids, visit, and treatment by visit||||-5.60|-12.79|<0.0001
72361721|NCT03186209|144234896|SUPERIORITY||Rate ratio|0.46||||0.0222|TWO_SIDED|95.0|0.24|0.9||Nominal p-value. Not multiplicity protected by testing procedure.|Negative binomial|Model includes Treatment, use of maintenance oral corticosteroids, categorical variable of ER/UC or hospitalization exacerbations during previous year||||0.90|0.24|0.0222
72361722|NCT03186209|144234900|SUPERIORITY||Mean Difference (Final Values)|-119.31|||<|0.0001|TWO_SIDED|95.0|-169.78|-68.84||Nominal p-value. Not multiplicity protected by testing procedure.|Mixed Models Analysis|model includes treatment , baseline eosinophil count, region, use of maintenance oral corticosteroids, visit, and treatment by visit||||-68.84|-169.78|<0.0001
72361723|NCT03186209|144234901|SUPERIORITY||Rate Ratio|0.83||||0.4519|TWO_SIDED|95.0|0.51|1.35||Nominal p-value. Not multiplicity protected by testing procedure.|Negative binomial|Model with covariates: treatment group, region (China/Non-China), number of exacerbations in previous year, use of maintenance oral corticosteroids||||1.35|0.51|0.4519
72361724|NCT03186209|144234902|SUPERIORITY||Mean Difference (Final Values)|0.12||||0.0214|TWO_SIDED|95.0|0.02|0.22||Nominal p-value. Not multiplicity protected by testing procedure.|Mixed Models Analysis|Model includes Treatment, baseline pre-bronchodilator FEV1, region, use of maintenance oral corticosteroids, visit, and treatment by visit||||0.22|0.02|0.0214
72361725|NCT03186209|144234903|SUPERIORITY||Mean Difference (Final Values)|-0.21||||0.1589|TWO_SIDED|95.0|-0.51|0.08||Nominal p-value. Not multiplicity protected by testing procedure.|Mixed Models Analysis|Model includes Treatment, baseline total asthma symptom score, region, use of maintenance oral corticosteroids, visit, and treatment by visit||||0.08|-0.51|0.1589
72361726|NCT00333775|144234920|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.79||||0.0318|TWO_SIDED|95.0|0.63|0.98|||Log Rank|||||0.98|0.63|0.0318
72361727|NCT00333775|144234920|SUPERIORITY_OR_OTHER||Hazard Ratio, log|0.72||||0.0036|TWO_SIDED|95.0|0.57|0.9|||Log Rank|||||0.90|0.57|0.0036
72361728|NCT00333775|144234923|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.85||||0.1105|TWO_SIDED|95.0|0.69|1.04|||Log Rank|||||1.04|0.69|0.1105
72361729|NCT00333775|144234923|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.79||||0.0241|TWO_SIDED|95.0|0.65|0.97|||Log Rank|||||0.97|0.65|0.0241
72361730|NCT00333775|144234924|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.92||||0.6962|TWO_SIDED|95.0|0.62|1.37|||Log Rank|||||1.37|0.62|0.6962
72361731|NCT00333775|144234924|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.68||||0.0765|TWO_SIDED|95.0|0.45|1.04|||Log Rank|||||1.04|0.45|0.0765
72361732|NCT01856270|144234958|SUPERIORITY|The data from this study was compared with the data from the Natural History of Headache after Mild TBI which was previously published (Lucas, Hoffman, Bell, Dikmen. (2014), A prospective study of prevalence and characterization of headache following mild traumatic brain injury. Cephalalgia (34) 93-102).|Difference of proportions|0.114||||0.101|ONE_SIDED|95.0|-0.017|||A priori significance threshold α=.05|Fisher Exact||Confidence interval estimation method from Wallenstein (1997). 71 of 205 participants (at 3 Mo post) in the Natural History study endorsed having a headache more than once per week.|A positive difference of proportions would indicate an improvement in the Amitriptyline sample, while a negative difference would indicate a worsening.|||-0.017|.101
72361733|NCT01856270|144234959|SUPERIORITY|The data from this study was compared with the data from the Natural History of Headache after Mild TBI which was previously published (Lucas, Hoffman, Bell, Dikmen. (2014), A prospective study of prevalence and characterization of headache following mild traumatic brain injury. Cephalalgia (34) 93-102).|Difference of proportions|0.194||||0.017|ONE_SIDED|95.0|0.057|||A priori significance threshold α=.05|Fisher Exact||Confidence interval estimation method from Wallenstein (1997). 56 of 148 participants (at 3 mo post) in the Natural History study reported pain \>=6.|A positive difference of proportions would indicate an improvement in the Amitriptyline sample, while a negative difference would indicate a worsening|||.057|.017
72361734|NCT01856270|144234960|SUPERIORITY||Difference of proportions|0.093||||0.456|TWO_SIDED|95.0|-0.106|0.286||A priori significance threshold α=.05|Fisher Exact||Estimate is the effect observed in the Immediate group (i.e. Immediate - Delayed). Confidence interval estimation method from Wallenstein (1997).|||.286|-.106|.456
72361735|NCT01856270|144234961|SUPERIORITY||Mean Difference (Final Values)|-0.8||||0.684|TWO_SIDED|95.0|-5.1|3.4||A priori significance threshold α=.05|t-test, 2 sided||Estimate is the effect observed in the Immediate group (i.e. Immediate - Delayed)|||3.4|-5.1|.684
72361736|NCT01856270|144234962|SUPERIORITY||Mean Difference (Final Values)|1.0||||0.306|TWO_SIDED|95.0|-1.0|2.9||A priori significance threshold α=.05|t-test, 2 sided||Estimate is the effect observed in the Immediate group (i.e. Immediate - Delayed)|||2.9|-1.0|.306
72361737|NCT01856270|144234963|SUPERIORITY||Mean Difference (Final Values)|0.3||||0.583|TWO_SIDED|95.0|-0.9|1.6||A priori significance threshold α=.05|t-test, 2 sided||Estimate is the effect observed in the Immediate group (i.e. Immediate - Delayed)|||1.6|-0.9|.583
72361738|NCT01856270|144234964|SUPERIORITY||Mean Difference (Final Values)|2.4||||0.444|TWO_SIDED|95.0|-4.0|8.8||A priori significance threshold α=.05|t-test, 2 sided||Estimate is the effect observed in the Immediate group (i.e. Immediate - Delayed)|||8.8|-4.0|.444
72361739|NCT01856270|144234965|SUPERIORITY||Mean Difference (Final Values)|27.3||||0.041|TWO_SIDED|95.0|1.2|53.3||A priori significance threshold α=.05|t-test, 2 sided||Estimate is the effect observed in the Immediate group (i.e. Immediate - Delayed)|||53.3|1.2|.041
72361740|NCT01856270|144234966|SUPERIORITY||Mean Difference (Final Values)|-1.8||||0.089|TWO_SIDED|95.0|-3.8|0.3||A priori significance threshold α=.05|t-test, 2 sided||Estimate is the effect observed in the Immediate group (i.e. Immediate - Delayed)|||0.3|-3.8|.089
72361741|NCT02242942|144235007|SUPERIORITY||Hazard Ratio (HR)|0.33|||<|0.0001|TWO_SIDED|95.0|0.22|0.51|||Log Rank||Hazard ratios were estimated by Cox regression model. Stratification factors: Binet and Geographic region.|||0.51|0.22|<0.0001
72361742|NCT02242942|144235008|SUPERIORITY||Hazard Ratio (HR)|0.35|||<|0.0001|TWO_SIDED|95.0|0.23|0.53|||Log Rank||Hazard Ratios were estimated by Cox regression model. Stratification factors: Binet and Geographic region.|||0.53|0.23|<0.0001
72361743|NCT02242942|144235009|SUPERIORITY||Difference in Response Rates|13.43||||0.0007|TWO_SIDED|95.0|5.47|21.38||P-value was assessed using Cochran-Mantel-Haenszel (CMH) test stratified by the IvRS randomization stratification factors.|Cochran-Mantel-Haenszel||95% Confidence Interval (CI) for difference in rates were constructed using Anderson-Hauck method.|||21.38|5.47|0.0007
72361744|NCT02242942|144235010|SUPERIORITY||Difference in Response Rates|26.39|||<|0.0001|TWO_SIDED|95.0|17.41|35.36||P-value was assessed using CMH test stratified by the IvRS randomization stratification factors.|Cochran-Mantel-Haenszel||95% CI for difference in rates were constructed using Anderson-Hauck method.|||35.36|17.41|<0.0001
72361745|NCT02242942|144235011|SUPERIORITY||Difference in MRD Negative Rates|40.28|||<|0.0001|TWO_SIDED|95.0|31.45|49.1|||Cochran-Mantel-Haenszel||95% CI for difference in rates were constructed using Anderson-Hauck method.|||49.10|31.45|<0.0001
72361746|NCT02242942|144235012|SUPERIORITY||Difference in MRD Negative Rates|39.81|||<|0.0001|TWO_SIDED|95.0|31.27|48.36|||Cochran-Mantel-Haenszel||95% CI for difference in rates were constructed using Anderson-Hauck method.|||48.36|31.27|<0.0001
72361747|NCT02242942|144235014|SUPERIORITY||Difference in MRD Negative Rates|32.87|||<|0.0001|TWO_SIDED|95.0|23.76|41.98|||Chi-squared||95% CI for difference in rates were constructed using Anderson-Hauck method.|||41.98|23.76|<0.0001
72361748|NCT02242942|144235015|SUPERIORITY||Difference in MRD Negative Rates|38.43|||<|0.0001|TWO_SIDED|95.0|30.15|46.71|||Chi-squared||95% CI for difference in rates were constructed using Anderson-Hauck method.|||46.71|30.15|<0.0001
72361749|NCT02242942|144235016|SUPERIORITY||Difference in Response Rates|1.85||||0.5612|TWO_SIDED|95.0|-4.63|8.33||P-value was assessed using Cochran-Mantel-Haenszel (CMH) test stratified by the IvRS randomization stratification factors.|Cochran-Mantel-Haenszel||95% Confidence Interval (CI) for difference in rates were constructed using Anderson-Hauck method.|||8.33|-4.63|0.5612
72361750|NCT02242942|144235018|SUPERIORITY||Difference in Response Rates|0.93||||0.7169|TWO_SIDED|95.0|-4.66|6.51|||Cochran-Mantel-Haenszel|P-value was assessed using CMH test stratified by the IvRS randomization stratification factors.|95% CI for difference in rates were constructed using Anderson-Hauck method.|||6.51|-4.66|0.7169
72361751|NCT01451606|144235076|SUPERIORITY|||||||0.52||||||Note that sample size was well below our target, making this test very low power.|Wilcoxon (Mann-Whitney)|||||||0.52
72361752|NCT01451606|144235077|SUPERIORITY|||||||0.84|||||||t-test, 2 sided|||||||0.84
72361753|NCT02559622|144235080|SUPERIORITY||Least Square (LS) mean difference|1.17||||0.223|TWO_SIDED|95.0|-0.72|3.06|||ANCOVA|||||3.06|-0.72|0.2230
72361754|NCT02163538|144235098|SUPERIORITY|||||||0.0001|||||||Wilcoxon (Mann-Whitney)|||||||0.0001
72361755|NCT02163538|144235099|SUPERIORITY|||||||1|||||||Chi-squared|||||||1.00
72361756|NCT02163538|144235100|SUPERIORITY|||||||0.582|||||||Chi-squared|||||||0.582
72361757|NCT02163538|144235101|SUPERIORITY|||||||0.0031|||||||Chi-squared|||||||0.0031
72361758|NCT02163538|144235102|SUPERIORITY|||||||0.0281|||||||Wilcoxon (Mann-Whitney)|||||||0.0281
72361759|NCT02163538|144235103|SUPERIORITY|||||||0.0821|||||||Wilcoxon (Mann-Whitney)|||||||.0821
72361760|NCT03668873|144235109|SUPERIORITY||Difference of Least Squares Means|-1.85|||<|0.001|TWO_SIDED|95.0|-2.88|-0.81||Threshold for significance was p=0.05.|Mixed Models Analysis|Mixed models with repeated measures with fixed effects for baseline CSI, treatment, week as a categorical variable, and treatment-week interaction.|Treatment difference = SPT minus SPE.|The null hypothesis was that the SPE and SPT groups did not differ on change in CSI score at 10 weeks. Assuming a standard deviation of 2.5 units and an attrition rate of 10%, an enrollment target of 90 participants would provide 90% power to detect a difference of 1.85 points or greater with a type I error rate of 0.05 using a two-tailed two-sample t-test.||-0.81|-2.88|<0.001
72361761|NCT03668873|144235110|SUPERIORITY||Absolute percent difference|24.0||||0.037|TWO_SIDED|95.0|2.0|46.0||Threshold for significance was 0.05|Chi-squared||Difference = SPT minus SPE.|The null hypothesis was that the SPE and SPT groups did not differ on the rate of positive response to CGI-I at 10 weeks. Assuming a 25%-40% positive response rate at 10 weeks in the SPE group and 45 patients per group, power was 90% to detect a 32% or greater difference in positive response rate (57%-72% in SPT group, respectively), with a type I error rate of 0.05 using a Chi-square test.||46|2|0.037
72361762|NCT03668873|144235111|SUPERIORITY|||||||0.81||||||threshold for significant 0.05|Mixed Models Analysis|||||||0.81
72361763|NCT03668873|144235112|SUPERIORITY|||||||0.77||||||Threshold for significance was 0.05|Mixed Models Analysis|||||||0.77
72361764|NCT03668873|144235113|SUPERIORITY|||||||0.003||||||Threshold for significance was 0.05|Mixed Models Analysis|||||||0.003
72361765|NCT02183675|144235115|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority limits: 80% - 125%|Adjusted geometric mean ratio (%)|108.39|STANDARD_ERROR_OF_MEAN|1.094|||TWO_SIDED|90.0|93.081|126.225|||ANOVA|The model included effects accounting for the following sources of variation: sequence, subjects within sequences, period and treatment.|Ratio calculated as T80-A5-H12.5 divided by T80-H12.5|||126.225|93.081|
72361766|NCT02183675|144235115|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority limits: 80% - 125%|Adjusted geometric mean ratio (%)|114.86|STANDARD_ERROR_OF_MEAN|1.097|||TWO_SIDED|90.0|98.216|134.326|||ANOVA|The model included effects accounting for the following sources of variation: sequence, subjects within sequences, period and treatment.|Ratio calculated as T80-A5-H12.5 divided by T80-A5|||134.326|98.216|
72361767|NCT02183675|144235116|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority limits: 80% - 125%|Adjusted geometric mean ratio (%)|97.53|STANDARD_ERROR_OF_MEAN|1.05|||TWO_SIDED|90.0|90.43|105.19|||ANOVA|The model included effects accounting for the following sources of variation: sequence, subjects within sequences, period and treatment.|Ratio calculated as T80-A5-H12.5 divided by T80-H12.5|||105.19|90.43|
72361768|NCT02183675|144235116|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority limits: 80% - 125%|Adjusted geometric mean ratio (%)|102.04|STANDARD_ERROR_OF_MEAN|1.03|||TWO_SIDED|90.0|96.94|107.4|||ANOVA|The model included effects accounting for the following sources of variation: sequence, subjects within sequences, period and treatment.|Ratio calculated as T80-A5-H12.5 divided by T80-A5|||107.40|96.94|
72361769|NCT02183675|144235117|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority limits: 80% - 125%|Adjusted geometric mean ratio (%)|104.8|STANDARD_ERROR_OF_MEAN|1.016|||TWO_SIDED|90.0|101.949|107.734|||ANOVA|The model included effects accounting for the following sources of variation: sequence, subjects within sequences, period and treatment.|Ratio calculated as T80-A5-H12.5 divided by T80-H12.5|||107.734|101.949|
72361770|NCT02183675|144235118|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority limits: 80% - 125%|Adjusted geometric mean ratio (%)|103.95|STANDARD_ERROR_OF_MEAN|1.017|||TWO_SIDED|90.0|101.023|106.964|||ANOVA|The model included effects accounting for the following sources of variation: sequence, subjects within sequences, period and treatment.|Ratio calculated as T80-A5-H12.5 divided by T80-A5|||106.964|101.023|
72361771|NCT02183675|144235119|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority limits: 80% - 125%|Adjusted geometric mean ratio (%)|102.49|STANDARD_ERROR_OF_MEAN|1.014|||TWO_SIDED|90.0|100.167|104.867|||ANOVA|The model included effects accounting for the following sources of variation: sequence, subjects within sequences, period and treatment.|Ratio calculated as T80-A5-H12.5 divided by T80-A5|||104.867|100.167|
72361772|NCT02183675|144235120|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority limits: 80% - 125%|Adjusted geometric mean ratio (%)|105.35|STANDARD_ERROR_OF_MEAN|1.036|||TWO_SIDED|90.0|99.23|111.847|||ANOVA|The model included effects accounting for the following sources of variation: sequence, subjects within sequences, period and treatment.|Ratio calculated as T80-A5-H12.5 divided by T80-H12.5|||111.847|99.230|
72361773|NCT02183675|144235121|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority limits: 80% - 125%|Adjusted geometric mean ratio (%)|103.39|STANDARD_ERROR_OF_MEAN|1.028|||TWO_SIDED|90.0|98.73|108.28|||ANOVA|The model included effects accounting for the following sources of variation: sequence, subjects within sequences, period and treatment.|Ratio calculated as T80-A5-H12.5 divided by T80-H12.5|||108.280|98.730|
72361774|NCT00784563|144235125|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Because all treatment arms were designed to deliver a similar average aerobic intensity, we planned to pool a priori all completers from the Continuous and Interval Training Arms for analysis.|Regression, Linear|||Sample size was estimated using 80% power to detect an effect size of 0.66 SD in VO2max (estimated improvement=10% /estimated SD of change=15%) within each arm at alpha=0.05 and an attrition rate of 25%.||||<0.001
72361775|NCT00784563|144235126|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Regression, Linear|||||||<0.001
72361776|NCT00784563|144235127|SUPERIORITY_OR_OTHER|||||||0.029|TWO_SIDED||||||Regression, Linear|||||||0.029
72361777|NCT00784563|144235128|SUPERIORITY_OR_OTHER|||||||0.271|TWO_SIDED||||||Regression, Linear|||||||0.271
72361778|NCT00784563|144235129|SUPERIORITY_OR_OTHER|||||||0.07|TWO_SIDED|||||unadjusted p-value=0.009|Regression, Linear|||||||0.070
72361779|NCT00784563|144235130|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Regression, Linear|||||||<0.001
72361780|NCT00784563|144235131|SUPERIORITY_OR_OTHER|||||||0.006|TWO_SIDED||||||Regression, Linear|||||||0.006
72361781|NCT00784563|144235132|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED||||||Regression, Linear|||||||0.002
72361782|NCT00784563|144235133|SUPERIORITY_OR_OTHER|||||||0.003|TWO_SIDED||||||Regression, Linear|Adjusted for change in total daily equivalent levodopa dose||||||0.003
72361783|NCT00784563|144235134|SUPERIORITY_OR_OTHER||||||=|0.146|TWO_SIDED||||||t-test, 2 sided|||||||=0.146
72361784|NCT00784563|144235135|SUPERIORITY_OR_OTHER|||||||0.037|TWO_SIDED||||||Regression, Linear|||||||0.037
72361785|NCT00784563|144235136|SUPERIORITY_OR_OTHER|||||||0.057|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.057
72361786|NCT02761330|144235184|OTHER|||||||0.016||||||Not adjusted for multiple comparisons.|Wilcoxon Signed-Ranked Test|||Comparison between the Etomidate + ECT and Ketamine + ECT groups for the recovery rate of Psychomotor Vigilance Task (PVT) reaction time.||||0.016
72361787|NCT02761330|144235184|OTHER|||||||0.012||||||Not adjusted for multiple comparisons.|Wilcoxon Signed-Ranked Test|||Comparison between the Ketamine + ECT and Ketamine Alone groups for the recovery rate of Psychomotor Vigilance Task (PVT) reaction time.||||0.012
72361788|NCT02761330|144235184|OTHER|||||||0.031||||||Not adjusted for multiple comparisons.|Wilcoxon Signed-Ranked Test|||Comparison between the Etomidate + ECT and Ketamine + ECT groups for the recovery rate of Digital Symbol Substitution Task (DSST) reaction time.||||0.031
72361789|NCT02761330|144235184|OTHER|||||||0.203||||||Not adjusted for multiple comparisons.|Wilcoxon Signed-Ranked Test|||Comparison between the Ketamine + ECT and Ketamine Alone groups for the recovery rate of Digital Symbol Substitution Task (DSST) reaction time.||||0.203
72361790|NCT02761330|144235184|OTHER|||||||0.008||||||Not adjusted for multiple comparisons.|Wilcoxon Signed-Ranked Test|||Comparison between the Etomidate + ECT and Ketamine + ECT groups for the recovery rate of Motor Praxis Task (MP) reaction time.||||0.008
72361791|NCT02761330|144235184|OTHER|||||||0.496||||||Not adjusted for multiple comparisons.|Wilcoxon Signed-Ranked Test|||Comparison between the Ketamine + ECT and Ketamine Alone groups for the recovery rate of Motor Praxis Task (MP) reaction time.||||0.496
72361792|NCT02761330|144235184|OTHER|||||||0.844||||||Not adjusted for multiple comparisons.|Wilcoxon Signed-Ranked Test|||Comparison between the Etomidate + ECT and Ketamine + ECT groups for the recovery rate of Visual Object Learning Task (VOLT) reaction time.||||0.844
72361793|NCT02761330|144235184|OTHER|||||||0.016||||||Not adjusted for multiple comparisons.|Wilcoxon Signed-Ranked Test|||Comparison between the Ketamine + ECT and Ketamine Alone groups for the recovery rate of Visual Object Learning Task (VOLT) reaction time.||||0.016
72361794|NCT02761330|144235184|OTHER|||||||0.062||||||Not adjusted for multiple comparisons.|Wilcoxon Signed-Ranked Test|||Comparison between the Etomidate + ECT and Ketamine + ECT groups for the recovery rate of Abstract Matching task (AM) reaction time.||||0.062
72361795|NCT02761330|144235184|OTHER|||||||0.039||||||Not adjusted for multiple comparisons.|Wilcoxon Signed-Ranked Test|||Comparison between the Ketamine + ECT and Ketamine Alone groups for the recovery rate of Abstract Matching task (AM) reaction time.||||0.039
72361796|NCT02761330|144235185|OTHER|||||||0.016||||||Not adjusted for multiple comparisons.|Wilcoxon Signed-Ranked Test|||Comparison between the Etomidate + ECT and Ketamine + ECT groups for the initial decrement of Psychomotor Vigilance Task (PVT) reaction time.||||0.016
72361797|NCT02761330|144235185|OTHER|||||||0.039||||||Not adjusted for multiple comparisons.|Wilcoxon Signed-Ranked Test|||Comparison between the Ketamine + ECT and Ketamine Alone groups for the recovery rate of Psychomotor Vigilance Task (PVT) reaction time.||||0.039
72361798|NCT02761330|144235185|OTHER|||||||0.031||||||Not adjusted for multiple comparisons.|Wilcoxon Signed-Ranked Test|||Comparison between the Etomidate + ECT and Ketamine + ECT groups for the initial decrement of Digital Symbol Substitution Task (DSST) reaction time.||||0.031
72361799|NCT02761330|144235185|OTHER|||||||1||||||Not adjusted for multiple comparisons.|Wilcoxon Signed-Ranked Test|||Comparison between the Ketamine + ECT and Ketamine Alone groups for the initial decrement of Digital Symbol Substitution Task (DSST) reaction time.||||1.0
72361800|NCT02761330|144235185|OTHER|||||||0.195||||||Not adjusted for multiple comparisons.|Wilcoxon Signed-Ranked Test|||Comparison between the Etomidate + ECT and Ketamine + ECT groups for the initial decrement of Motor Praxis task (MP) reaction time.||||0.195
72361801|NCT02761330|144235185|OTHER|||||||0.57||||||Not adjusted for multiple comparisons.|Wilcoxon Signed-Ranked Test|||Comparison between the Ketamine + ECT and Ketamine Alone groups for the initial decrement of Motor Praxis task (MP) reaction time.||||0.570
72361802|NCT02761330|144235185|OTHER|||||||0.031||||||Not adjusted for multiple comparisons.|Wilcoxon Signed-Ranked Test|||Comparison between the Etomidate + ECT and Ketamine + ECT groups for the initial decrement of Visual Object Learning Task (VOLT) reaction time.||||0.031
72361803|NCT02761330|144235185|OTHER|||||||0.016||||||Not adjusted for multiple comparisons.|Wilcoxon Signed-Ranked Test|||Comparison between the Ketamine + ECT and Ketamine Alone groups for the initial decrement of Visual Object Learning Task (VOLT) reaction time.||||0.016
72361804|NCT02761330|144235185|OTHER|||||||1||||||Not adjusted for multiple comparisons.|Wilcoxon Signed-Ranked Test|||Comparison between the Etomidate + ECT and Ketamine + ECT groups for the initial decrement of Abstract Matching (AM) task reaction time.||||1.00
72361805|NCT02761330|144235185|OTHER|||||||0.109||||||Not adjusted for multiple comparisons.|Wilcoxon Signed-Ranked Test|||Comparison between the Ketamine + ECT and Ketamine Alone groups for the initial decrement of Abstract Matching (AM) task reaction time.||||0.109
72361806|NCT02761330|144235193|OTHER|||||||0.301|||||||Wilcoxon signed-rank paired test|||Comparison of relative power in the delta band at baseline compared to T0 following return of responsiveness.||||0.301
72361807|NCT02761330|144235193|OTHER|||||||0.301|||||||Wilcoxon signed-rank paired test|||Comparison of relative power in the delta band at baseline compared to T0 following return of responsiveness.||||0.301
72361808|NCT02761330|144235193|OTHER|||||||0.557|||||||Wilcoxon signed-rank paired test|||Comparison of relative power in the delta band at baseline compared to T0 following return of responsiveness.||||0.557
72361809|NCT02761330|144235194|OTHER|||||||0.91|||||||Wilcoxon signed-rank paired test|||Comparison of relative power in the theta band at baseline compared to T0 following return of responsiveness.||||0.910
72361810|NCT02761330|144235194|OTHER|||||||0.734|||||||Wilcoxon signed-rank paired test|||Comparison of relative power in the theta band at baseline compared to T0 following return of responsiveness.||||0.734
72361811|NCT02761330|144235194|OTHER|||||||0.322|||||||Wilcoxon signed-rank paired test|||Comparison of relative power in the theta band at baseline compared to T0 following return of responsiveness.||||0.322
72361812|NCT02761330|144235195|OTHER|||||||0.164|||||||Wilcoxon signed-rank paired test|||Comparison of relative power in the alpha band at baseline compared to T0 following return of responsiveness.||||0.164
72361813|NCT02761330|144235195|OTHER|||||||0.039|||||||Wilcoxon signed-rank paired test|||Comparison of relative power in the alpha band at baseline compared to T0 following return of responsiveness.||||0.039
72361814|NCT02761330|144235195|OTHER|||||||0.375|||||||Wilcoxon signed-rank paired test|||Comparison of relative power in the alpha band at baseline compared to T0 following return of responsiveness.||||0.375
72361815|NCT02761330|144235196|OTHER|||||||0.91|||||||Wilcoxon signed-rank paired test|||Comparison of relative power in the beta band at baseline compared to T0 following return of responsiveness.||||0.910
72361816|NCT02761330|144235196|OTHER|||||||0.91|||||||Wilcoxon signed-rank paired test|||Comparison of relative power in the beta band at baseline compared to T0 following return of responsiveness.||||0.910
72361817|NCT02761330|144235196|OTHER|||||||0.625|||||||Wilcoxon signed-rank paired test|||Comparison of relative power in the beta band at baseline compared to T0 following return of responsiveness.||||0.625
72361818|NCT02761330|144235197|OTHER|||||||0.129|||||||Wilcoxon signed-rank paired test|||Comparison of anterior-posterior functional connectivity (coherence) at baseline compared to T0 following return of responsiveness.||||0.129
72361819|NCT02761330|144235197|OTHER|||||||0.91|||||||Wilcoxon signed-rank paired test|||Comparison of anterior-posterior functional connectivity (coherence) at baseline compared to T0 following return of responsiveness.||||0.910
72361820|NCT02761330|144235197|OTHER|||||||0.625|||||||Wilcoxon signed-rank paired test|||Comparison of anterior-posterior functional connectivity (coherence) at baseline compared to T0 following return of responsiveness.||||0.625
72361821|NCT02761330|144235198|OTHER|||||||1|||||||Wilcoxon signed-rank paired test|||Comparison of anterior-posterior phase-lag (PLI) at baseline compared to T0 following return of responsiveness.||||1.000
72361822|NCT02761330|144235198|OTHER|||||||0.496|||||||Wilcoxon signed-rank paired test|||Comparison of anterior-posterior phase-lag (PLI) at baseline compared to T0 following return of responsiveness.||||0.496
72361823|NCT02761330|144235198|OTHER|||||||0.16|||||||Wilcoxon signed-rank paired test|||Comparison of anterior-posterior phase-lag (PLI) at baseline compared to T0 following return of responsiveness.||||0.160
72361824|NCT02761330|144235199|OTHER|||||||0.008|||||||Wilcoxon Signed-Ranked Test|||Comparison of EEG Entropy using Permutation Entropy (PE) measures at baseline compared to T0 following return of responsiveness.||||0.008
72361825|NCT02761330|144235199|OTHER|||||||0.359|||||||Wilcoxon Signed-Ranked Test|||Comparison of EEG Entropy using Permutation Entropy (PE) measures at baseline compared to T0 following return of responsiveness.||||0.359
72361826|NCT02761330|144235199|OTHER|||||||0.375|||||||Wilcoxon Signed-Ranked Test|||Comparison of EEG Entropy using Permutation Entropy (PE) measures at baseline compared to T0 following return of responsiveness.||||0.375
72361827|NCT04576988|144235204|OTHER||Treatment difference|40.8|||<|0.001|TWO_SIDED|95.0|27.53|54.14||A 2-sided p-value was calculated using ARSW test with WHO FC II/III and background PAH therapy as strata.|Aligned Rank Stratified Wilcoxon (ARSW)|Participants who died were assigned the worst rank and who had missing data due to non-fatal clinical worsening event were assigned next worst-rank.|Hodges-Lehmann location-shift estimate of the overall treatment difference with 95% confidence interval (CI) was reported.|||54.14|27.53|<0.001
72361828|NCT04576988|144235207|OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|A 2-sided p-value was calculated using Cochran-Mantel-Haenszel (CMH) method with WHO FC II/III and background PAH therapy as strata.||||||<0.001
72361829|NCT04576988|144235208|OTHER||Treatment difference|-234.6|||<|0.001|TWO_SIDED|95.0|-288.37|-180.75||A 2-sided p-value was calculated using ARSW test with WHO FC II/III and background PAH therapy as strata.|ARSW test|Participants who died were assigned the worst rank and who had missing data due to non-fatal clinical worsening event were assigned next worst-rank.|Hodges-Lehmann location-shift estimate of the overall treatment difference with 95% CI was reported.|||-180.75|-288.37|<0.001
72361830|NCT04576988|144235209|OTHER||Treatment difference|-441.6|||<|0.001|TWO_SIDED|95.0|-573.54|-309.61||A 2-sided p-value was calculated using ARSW test with WHO FC II/III and background PAH therapy as strata.|ARSW test|Participants who died were assigned the worst rank and who had missing data due to non-fatal clinical worsening event were assigned next worst-rank.|Hodges-Lehmann location-shift estimate of the overall treatment difference with 95% CI was reported.|||-309.61|-573.54|<.001
72361831|NCT04576988|144235210|OTHER|A 2-sided p-value was calculated using CMH method with WHO FC II/III and background PAH therapy as strata.|||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
72361832|NCT04576988|144235211|OTHER|A 2-sided p-value was calculated using Log rank test with WHO FC II/III and background PAH therapy as strata.|Hazard Ratio (HR)|0.163|||<|0.001|TWO_SIDED|95.0|0.076|0.347|||Log Rank||Cox proportional hazard model was used to generate hazard ratio (HR) and 95% CI was reported with treatment group as the covariate stratified by the WHO FC II/III and background PAH therapy.|||0.347|0.076|<0.001
72361833|NCT04576988|144235212|OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|A 2-sided p-value was calculated using Cochran-Mantel-Haenszel (CMH) method with WHO FC II/III and background PAH therapy as strata.||||||<0.001
72361834|NCT04576988|144235213|OTHER||Treatment difference|-0.26||||0.01|TWO_SIDED|95.0|-0.49|-0.04||A 2-sided p-value was calculated using ARSW test with WHO FC II/III and background PAH therapy as strata.|ARSW test|Participants who died were assigned the worst rank and who had missing data due to non-fatal clinical worsening event were assigned next worst-rank.|Hodges-Lehmann location-shift estimate of the overall treatment difference with 95% CI was reported.|||-0.040|-0.490|0.010
72361835|NCT04576988|144235214|OTHER||Treatment difference|-0.13||||0.028|TWO_SIDED|95.0|-0.256|-0.014||A 2-sided p-value was calculated using ARSW test with WHO FC II/III and background PAH therapy as strata.|ARSW test|Participants who died were assigned the worst rank and who had missing data due to non-fatal clinical worsening event were assigned next worst-rank.|Hodges-Lehmann location-shift estimate of the overall treatment difference with 95% CI was reported.|||-0.014|-0.256|0.028
72361836|NCT04576988|144235215|OTHER||Treatment difference|-0.16||||0.156|TWO_SIDED|95.0|-0.399|0.084||A 2-sided p-value was calculated using ARSW test with WHO FC II/III and background PAH therapy as strata.|ARSW test|Participants who died were assigned the worst rank and who had missing data due to non-fatal clinical worsening event were assigned next worst-rank.|Hodges-Lehmann location-shift estimate of the overall treatment difference with 95% CI was reported.|||0.084|-0.399|0.156
72361837|NCT01576341|144235216|OTHER||Incidence rate|0.019|||||TWO_SIDED||||||||Incidence rate is based on duration of treatment period (years)|||||
72361838|NCT00617734|144235218|SUPERIORITY_OR_OTHER|||||||0.0667|||||||Log Rank|||||||0.0667
72361839|NCT00617734|144235219|SUPERIORITY_OR_OTHER|||||||0.1935|||||||Fisher Exact|||||||0.1935
72361840|NCT00617734|144235221|SUPERIORITY_OR_OTHER|||||||0.7455|||||||Log Rank|||||||0.7455
72361841|NCT03905096|144235277|OTHER|Relative bioavailability|Ratio of the geometric means (T/R) %|92.63|STANDARD_DEVIATION|12.4|||TWO_SIDED|90.0|85.34|100.53|||ANOVA|"The statistical model was analysis of variance (ANOVA) on the logarithmic scale considering the effects subjects as random and treatment as fixed."|The standard deviation is actually the geometric coefficient of variation (gCV) T=Test, R=Reference|||100.53|85.34|
72361842|NCT03905096|144235278|OTHER|Relative bioavailability|Ratio of the geometric means (T/R) %|98.64|STANDARD_DEVIATION|6.9|||TWO_SIDED|90.0|93.21|104.39|||ANOVA|"The statistical model was ANOVA on the logarithmic scale considering the effect subjects as random and the effect treatment as fixed."|The standard deviation is actually the geometric coefficient of variation (gCV) T=Test, R=Reference|||104.39|93.21|
72361843|NCT03905096|144235279|OTHER|Relative bioavailability|Ratio of the geometric means (T/R) %|98.48|STANDARD_DEVIATION|12.4|||TWO_SIDED|90.0|90.74|106.88|||ANOVA|"The statistical model was ANOVA on the logarithmic scale considering the effect subjects as random and the effect treatment as fixed."|The standard deviation is actually the geometric coefficient of variation (gCV) T=Test, R=Reference|||106.88|90.74|
72361844|NCT03905096|144235280|OTHER|Relative bioavailability|Ratio of the geometric means (T/R) %|100.15|STANDARD_DEVIATION|14.4|||TWO_SIDED|90.0|89.01|112.68|||ANOVA|"The statistical model was ANOVA on the logarithmic scale considering the effect subjects as random and the effect treatment as fixed."|The standard deviation is actually the geometric coefficient of variation (gCV) T=Test, R=Reference|||112.68|89.01|
72361845|NCT03905096|144235281|OTHER|Relative bioavailability|Ratio of the geometric means (T/R) %|94.77|STANDARD_DEVIATION|10.6|||TWO_SIDED|90.0|88.36|101.64|||ANOVA|"The statistical model was ANOVA on the logarithmic scale considering the effect subjects as random and the effect treatment as fixed."|The standard deviation is actually the geometric coefficient of variation (gCV) T=Test, R=Reference|||101.64|88.36|
72361846|NCT03905096|144235282|OTHER|Relative bioavailability|Ratio of the geometric means (T/R) %|100.06|STANDARD_DEVIATION|6.9|||TWO_SIDED|90.0|94.56|105.87|||ANOVA|"The statistical model was ANOVA on the logarithmic scale considering the effect subjects as random and the effect treatment as fixed."|The standard deviation is actually the geometric coefficient of variation (gCV) T=Test, R=Reference|||105.87|94.56|
72361847|NCT02016781|144235283|SUPERIORITY|||||||0.0001||||||Statistical significance was determined using a pre-specified threshold of 0.05.|Wald test|Wald test of difference in adjusted OS estimates.||The null hypothesis is that the rates of three-year OS are the same for both treatments. The results posted are from the interim analysis per protocol study design.||||0.0001
72361848|NCT02016781|144235283|SUPERIORITY|||||||0.3345||||||Statistical significance was determined using a pre-specified threshold of 0.05.|pseudo-value regression models|Overall Wald test of interaction terms between response to hypomethylating therapy and treatment assignment in regression model.||This subgroup analysis investigated the differential impact of response to hypomethylating therapy (No Response to Hypomethylation vs. Any Response or Hematologic Improvement to Hypomethylation vs. No Prior Hypomethylation) on the treatment effect for OS at three years post-consent for the HCT arm vs. the non-HCT arm. The analysis was conducted using pseudo-value regression models via an interaction term between the factor and the treatment group with a logit link function.||||0.3345
72361849|NCT02016781|144235283|SUPERIORITY|||||||0.7328||||||Statistical significance was determined using a pre-specified threshold of 0.05.|pseudo-value regression models|Overall Wald test of interaction terms between patient age and treatment assignment in regression model.||This subgroup analysis investigated the differential impact of patient age (\< vs. \>= 65) on the treatment effect for OS at three years post-consent for the HCT arm vs. the non-HCT arm. The analysis was conducted using pseudo-value regression models via an interaction term between the factor and the treatment group with a logit link function.||||0.7328
72361850|NCT02016781|144235283|SUPERIORITY|||||||0.6261||||||Statistical significance was determined using a pre-specified threshold of 0.05.|pseudo-value regression models|Overall Wald test of interaction terms between disease duration and treatment assignment in regression model.||This subgroup analysis investigated the differential impact of disease duration (less than vs. 3 months or more) on the treatment effect for OS at three years post-consent for the HCT arm vs. the non-HCT arm. The analysis was conducted using pseudo-value regression models via an interaction term between the factor and the treatment group with a logit link function.||||0.6261
72361851|NCT02016781|144235283|SUPERIORITY|||||||0.4134||||||Statistical significance was determined using a pre-specified threshold of 0.05.|pseudo-value regression models|Overall Wald test of interaction terms between IPSS score and treatment assignment in regression model.||This subgroup analysis investigated the differential impact of IPSS score (Intermediate-2 vs. High) on the treatment effect for OS at three years post-consent for the HCT arm vs. the non-HCT arm. The analysis was conducted using pseudo-value regression models via an interaction term between the factor and the treatment group with a logit link function.||||0.4134
72361852|NCT02016781|144235283|SUPERIORITY|||||||0.3147||||||Statistical significance was determined using a pre-specified threshold of 0.05.|pseudo-value regression models|Overall Wald test of interaction terms between IPSS-R score and treatment assignment in regression model.||Statistical Analysis 6: This subgroup analysis investigated the differential impact of IPSS-R score (Very Low, Low, or Intermediate vs. High vs. Very High) on the treatment effect for OS at three years post-consent for the HCT arm vs. the non-HCT arm. The analysis was conducted using pseudo-value regression models via an interaction term between the factor and the treatment group with a logit link function.||||0.3147
72361853|NCT02016781|144235284|SUPERIORITY|||||||0.003||||||Statistical significance was determined using a pre-specified threshold of 0.05.|Wald test|||The null hypothesis is that the rates of three-year LFS are the same for both treatments.||||0.0030
72361854|NCT02016781|144235284|SUPERIORITY|||||||0.9908||||||Statistical significance was determined using a pre-specified threshold of 0.05.|pseudo-value regression models|||This subgroup analysis investigated the differential impact of response to hypomethylating therapy on the treatment effect for LFS at three years post-consent for the HCT arm vs. the non-HCT arm. The analysis was conducted using pseudo-value regression models via an interaction term between the factor and the treatment group with a logit link function.||||0.9908
72361855|NCT02016781|144235284|SUPERIORITY|||||||0.8981||||||Statistical significance was determined using a pre-specified threshold of 0.05.|pseudo-value regression models|||This subgroup analysis investigated the differential impact of patient age (\< or \>= 65) on the treatment effect for LFS at three years post-consent for the HCT arm vs. the non-HCT arm. The analysis was conducted using pseudo-value regression models via an interaction term between the factor and the treatment group with a logit link function.||||0.8981
72361856|NCT02016781|144235284|SUPERIORITY|||||||0.1465||||||Statistical significance was determined using a pre-specified threshold of 0.05.|pseudo-value regression models|||This subgroup analysis investigated the differential impact of disease duration (less than vs. 3 months or more) on the treatment effect for LFS at three years post-consent for the HCT arm vs. the non-HCT arm. The analysis was conducted using pseudo-value regression models via an interaction term between the factor and the treatment group with a logit link function.||||0.1465
72361857|NCT02016781|144235284|SUPERIORITY|Statistical significance was determined using a pre-specified threshold of 0.05.||||||0.4991|||||||pseudo-value regression models|||This subgroup analysis investigated the differential impact of IPSS score (Intermediate-2 vs. High) on the treatment effect for LFS at three years post-consent for the HCT arm vs. the non-HCT arm. The analysis was conducted using pseudo-value regression models via an interaction term between the factor and the treatment group with a logit link function.||||0.4991
72361858|NCT02016781|144235284|SUPERIORITY|||||||0.4953||||||Statistical significance was determined using a pre-specified threshold of 0.05.|pseudo-value regression models|||This subgroup analysis investigated the differential impact of IPSS-R score on the treatment effect for LFS at three years post-consent for the HCT arm vs. the non-HCT arm. The analysis was conducted using pseudo-value regression models via an interaction term between the factor and the treatment group with a logit link function.||||0.4953
72361859|NCT02016781|144235285|SUPERIORITY|||||||0.2777||||||Statistical significance was determined using a pre-specified threshold of 0.05.|t-test, 2 sided|||The null hypothesis is that the FACT-G scores are the same at Enrollment for both treatments.||||0.2777
72361860|NCT02016781|144235285|SUPERIORITY|||||||0.225||||||Statistical significance was determined using a pre-specified threshold of 0.05.|ANOVA|Changes in scores from enrollment were compared between arms using ANOVA models with treatment arm as main effect and enrollment score as a covariate||The null hypothesis is that the changes in FACT-G scores from enrollment are the same at 6 Months for both treatments.||||0.2250
72361861|NCT02016781|144235285|SUPERIORITY|||||||0.1048||||||Statistical significance was determined using a pre-specified threshold of 0.05.|ANOVA|Changes in scores from enrollment were compared between arms using ANOVA models with treatment arm as main effect and enrollment score as a covariate||The null hypothesis is that the changes in FACT-G scores from enrollment are the same at 12 Months for both treatments.||||0.1048
72361862|NCT02016781|144235285|SUPERIORITY|||||||0.0888||||||Statistical significance was determined using a pre-specified threshold of 0.05.|ANOVA|Changes in scores from enrollment were compared between arms using ANOVA models with treatment arm as main effect and enrollment score as a covariate||The null hypothesis is that the changes in FACT-G scores from enrollment are the same at 18 Months for both treatments.||||0.0888
72361863|NCT02016781|144235285|SUPERIORITY|||||||0.5844||||||Statistical significance was determined using a pre-specified threshold of 0.05.|ANOVA|Changes in scores from enrollment were compared between arms using ANOVA models with treatment arm as main effect and enrollment score as a covariate||The null hypothesis is that the changes in FACT-G scores from enrollment are the same at 24 Months for both treatments.||||0.5844
72361864|NCT02016781|144235285|SUPERIORITY|||||||0.0344||||||Statistical significance was determined using a pre-specified threshold of 0.05.|ANOVA|Changes in scores from enrollment were compared between arms using ANOVA models with treatment arm as main effect and enrollment score as a covariate||The null hypothesis is that the changes in FACT-G scores from enrollment are the same at 36 Months for both treatments.||||0.0344
72361865|NCT02016781|144235286|SUPERIORITY|||||||0.5583||||||Statistical significance was determined using a pre-specified threshold of 0.05.|t-test, 2 sided|||The null hypothesis is that the MOS SF-36 PCS scores are the same at Enrollment for both treatments.||||0.5583
72361866|NCT02016781|144235286|SUPERIORITY|||||||0.669||||||Statistical significance was determined using a pre-specified threshold of 0.05.|ANOVA|Changes in scores from enrollment were compared between arms using ANOVA models with treatment arm as main effect and enrollment score as a covariate||The null hypothesis is that the changes in MOS SF-36 PCS scores from enrollment are the same at 6 Months for both treatments.||||0.6690
72361867|NCT02016781|144235286|SUPERIORITY|||||||0.2089||||||Statistical significance was determined using a pre-specified threshold of 0.05.|ANOVA|Changes in scores from enrollment were compared between arms using ANOVA models with treatment arm as main effect and enrollment score as a covariate||The null hypothesis is that the changes in MOS SF-36 PCS scores from enrollment are the same at 12 Months for both treatments.||||0.2089
72361868|NCT02016781|144235286|SUPERIORITY|||||||0.4343||||||Statistical significance was determined using a pre-specified threshold of 0.05.|ANOVA|Changes in scores from enrollment were compared between arms using ANOVA models with treatment arm as main effect and enrollment score as a covariate||The null hypothesis is that the changes in MOS SF-36 PCS scores from enrollment are the same at 18 Months for both treatments.||||0.4343
72361869|NCT02016781|144235286|SUPERIORITY|||||||0.5942||||||Statistical significance was determined using a pre-specified threshold of 0.05.|ANOVA|Changes in scores from enrollment were compared between arms using ANOVA models with treatment arm as main effect and enrollment score as a covariate||The null hypothesis is that the changes in MOS SF-36 PCS scores from enrollment are the same at 24 Months for both treatments.||||0.5942
72361870|NCT02016781|144235286|SUPERIORITY|||||||0.1615||||||Statistical significance was determined using a pre-specified threshold of 0.05.|ANOVA|Changes in scores from enrollment were compared between arms using ANOVA models with treatment arm as main effect and enrollment score as a covariate||The null hypothesis is that the changes in MOS SF-36 PCS scores from enrollment are the same at 36 Months for both treatments.||||0.1615
72361871|NCT02016781|144235286|SUPERIORITY|||||||0.5659||||||Statistical significance was determined using a pre-specified threshold of 0.05.|t-test, 2 sided|||The null hypothesis is that the MOS SF-36 MCS scores are the same at Enrollment for both treatments.||||0.5659
72361872|NCT02016781|144235286|SUPERIORITY|||||||0.8555||||||Statistical significance was determined using a pre-specified threshold of 0.05.|ANOVA|Changes in scores from enrollment were compared between arms using ANOVA models with treatment arm as main effect and enrollment score as a covariate||The null hypothesis is that the changes in MOS SF-36 MCS scores from enrollment are the same at 6 Months for both treatments.||||0.8555
72361873|NCT02016781|144235286|SUPERIORITY|||||||0.8995||||||Statistical significance was determined using a pre-specified threshold of 0.05.|ANOVA|Changes in scores from enrollment were compared between arms using ANOVA models with treatment arm as main effect and enrollment score as a covariate||The null hypothesis is that the changes in MOS SF-36 MCS scores from enrollment are the same at 12 Months for both treatments.||||0.8995
72361874|NCT02016781|144235286|SUPERIORITY|||||||0.0105||||||Statistical significance was determined using a pre-specified threshold of 0.05.|ANOVA|Changes in scores from enrollment were compared between arms using ANOVA models with treatment arm as main effect and enrollment score as a covariate||The null hypothesis is that the changes in MOS SF-36 MCS scores from enrollment are the same at 18 Months for both treatments.||||0.0105
72361875|NCT02016781|144235286|SUPERIORITY|||||||0.2596||||||Statistical significance was determined using a pre-specified threshold of 0.05.|ANOVA|Changes in scores from enrollment were compared between arms using ANOVA models with treatment arm as main effect and enrollment score as a covariate||The null hypothesis is that the changes in MOS SF-36 MCS scores from enrollment are the same at 24 Months for both treatments.||||0.2596
72361876|NCT02016781|144235286|SUPERIORITY|||||||0.5022||||||Statistical significance was determined using a pre-specified threshold of 0.05.|ANOVA|Changes in scores from enrollment were compared between arms using ANOVA models with treatment arm as main effect and enrollment score as a covariate||The null hypothesis is that the changes in MOS SF-36 MCS scores from enrollment are the same at 36 Months for both treatments.||||0.5022
72361877|NCT02016781|144235287|SUPERIORITY|||||||0.1768||||||Statistical significance was determined using a pre-specified threshold of 0.05.|t-test, 2 sided|||The null hypothesis is that the EQ-5D scores are the same at Enrollment for both treatments.||||0.1768
72361878|NCT02016781|144235287|SUPERIORITY|||||||0.8318||||||Statistical significance was determined using a pre-specified threshold of 0.05.|ANOVA|Changes in scores from enrollment were compared between arms using ANOVA models with treatment arm as main effect and enrollment score as a covariate||The null hypothesis is that the changes in EQ-5D scores from enrollment are the same at 6 Months for both treatments.||||0.8318
72361879|NCT02016781|144235287|SUPERIORITY|||||||0.4752||||||Statistical significance was determined using a pre-specified threshold of 0.05.|ANOVA|Changes in scores from enrollment were compared between arms using ANOVA models with treatment arm as main effect and enrollment score as a covariate||The null hypothesis is that the changes in EQ-5D scores from enrollment are the same at 12 Months for both treatments.||||0.4752
72361880|NCT02016781|144235287|SUPERIORITY|||||||0.5671||||||Statistical significance was determined using a pre-specified threshold of 0.05.|ANOVA|Changes in scores from enrollment were compared between arms using ANOVA models with treatment arm as main effect and enrollment score as a covariate||The null hypothesis is that the changes in EQ-5D scores from enrollment are the same at 18 Months for both treatments.||||0.5671
72361881|NCT02016781|144235287|SUPERIORITY|||||||0.3009||||||Statistical significance was determined using a pre-specified threshold of 0.05.|ANOVA|Changes in scores from enrollment were compared between arms using ANOVA models with treatment arm as main effect and enrollment score as a covariate||The null hypothesis is that the changes in EQ-5D scores from enrollment are the same at 24 Months for both treatments.||||0.3009
72361882|NCT02016781|144235287|SUPERIORITY|||||||0.3403||||||Statistical significance was determined using a pre-specified threshold of 0.05.|ANOVA|Changes in scores from enrollment were compared between arms using ANOVA models with treatment arm as main effect and enrollment score as a covariate||The null hypothesis is that the changes in EQ-5D scores from enrollment are the same at 36 Months for both treatments.||||0.3403
72361883|NCT02016781|144235288|SUPERIORITY||||||<|0.0001||||||Statistical significance was determined using a pre-specified threshold of 0.05.|Wald test|||The null hypothesis is that the rates of three-year OS are the same for both treatments in treated population.||||< 0.0001
72361884|NCT02016781|144235289|SUPERIORITY||||||<|0.0001||||||Statistical significance was determined using a pre-specified threshold of 0.05.|Wald test|||The null hypothesis is that the rates of three-year LFS are the same for both treatments in treated population.||||< 0.0001
72361885|NCT01488045|144235367|EQUIVALENCE|We compared patient satisfaction for those receiving the 2 sedation regimens using the Schuirmann 2 one-sided t test procedure.15 The groups were declared to be equivalent in terms of patient satisfaction if the 90% CI for the difference in mean satisfaction had outer boundaries indicating \<5% difference on the 100-point VAS. Nonequivalence was declared if the lower 90% CI boundary for the difference was less than -5.0, or if the upper 90% CI boundary for the difference was \>5.0.|Mean Difference (Final Values)|-14.0741|STANDARD_DEVIATION|22.2|||TWO_SIDED|95.0|-18.5|-9.6||||||To calculate the required sample size for this study, the equivalence limit was set at 5 units difference on the VAS, with an expected mean difference of 0. The common SD of 16.2 was estimated based on the range of expected scores for the VAS from Ulmer et al. Using these inputs, a total sample size of 262 patients was estimated to have 80% power to reject the null hypothesis that the test and standard were not equivalent and conclude that they were equivalent.||-9.6|-18.5|
72361886|NCT00989911|144235373|SUPERIORITY_OR_OTHER|||||||0.03|TWO_SIDED||||||t-test, 2 sided|||||||0.03
72361887|NCT03405792|144235374|OTHER|||||||||||||||||We will use one-sample log-rank test to compare PFS between the triple combination arm relative to the historical control arm.|We took a look at median survival time and CI of our population and we compared it to the median PFS and CI of the historical control descriptively. There is no yielded P value.|||
72361888|NCT03405792|144235375|OTHER||||||||||||||||||Every participant (26/26; 100%) experienced an adverse event.|||
72361889|NCT03882021|144235387|OTHER||Kaplan Meier Survival Estimate|57.2|STANDARD_ERROR_OF_MEAN|3.0|||TWO_SIDED|95.0|51.2|62.8|||||Kaplan-Meier estimate of freedom from recurrence after removal from AAD at one year.|||62.8|51.2|
72361890|NCT03882021|144235388|OTHER|Kaplan Meier Estimate of freedom from symptomatic recurrence.|Kaplan-Meier Survival Estimate|61.7|STANDARD_ERROR_OF_MEAN|2.9|||TWO_SIDED|95.0|55.8|67.1|||||Kaplan-Meier estimate of freedom from symptomatic AF/AFL/AT recurrence after removal from AAD|||67.1|55.8|
72361891|NCT03882021|144235389|OTHER|Kaplan Meier estimate of single procedure clinical success.|Kaplan-Meier Survival Estimate|79.4|STANDARD_ERROR_OF_MEAN|2.4|||TWO_SIDED|95.0|74.2|83.6|||||Kaplan-Meier estimate of freedom from symptomatic AF/AFL/AT without new or increased dose of Class I/III AAD at one year.|||83.6|74.2|
72361892|NCT03882021|144235390|OTHER|Kaplan Meier estimate of freedom from AF/AFL/AT|Kaplan Meier Survival Estimate|75.5|STANDARD_ERROR_OF_MEAN|2.6|||TWO_SIDED|95.0|69.9|80.1|||||Kaplan Meier estimate of freedom from AF/AFL/AT at 12 months.|||80.1|69.9|
72361893|NCT03486912|144235397|SUPERIORITY||Odds Ratio (OR)|0.88||||0.773|TWO_SIDED|95.0|0.3|2.62|||Cochran-Mantel-Haenszel|||||2.62|0.30|0.773
72361894|NCT03486912|144235397|SUPERIORITY||Odds Ratio (OR)|0.72||||0.544|TWO_SIDED|95.0|0.23|2.23|||Cochran-Mantel-Haenszel|||||2.23|0.23|0.544
72361895|NCT03486912|144235397|SUPERIORITY||Odds Ratio (OR)|0.88||||0.811|TWO_SIDED|95.0|0.3|2.62|||Cochran-Mantel-Haenszel|||||2.62|0.30|0.811
72361896|NCT03486912|144235398|SUPERIORITY||Odds Ratio (OR)|1.12||||0.836|TWO_SIDED|95.0|0.4|3.09|||Cochran-Mantel-Haenszel|||||3.09|0.40|0.836
72361897|NCT03486912|144235398|SUPERIORITY||Odds Ratio (OR)|0.86||||0.763|TWO_SIDED|95.0|0.3|2.46|||Cochran-Mantel-Haenszel|||||2.46|0.30|0.763
72361898|NCT03486912|144235398|SUPERIORITY||Odds Ratio (OR)|0.89||||0.821|TWO_SIDED|95.0|0.32|2.51|||Cochran-Mantel-Haenszel|||||2.51|0.32|0.821
72361899|NCT03486912|144235399|SUPERIORITY||Odds Ratio (OR)|1.13||||0.837|TWO_SIDED|95.0|0.39|3.25|||Cochran-Mantel-Haenszel|||||3.25|0.39|0.837
72361900|NCT03486912|144235399|SUPERIORITY||Odds Ratio (OR)|1.53||||0.359|TWO_SIDED|95.0|0.54|4.4|||Cochran-Mantel-Haenszel|||||4.40|0.54|0.359
72361901|NCT03486912|144235399|SUPERIORITY||Odds Ratio (OR)|1.26||||0.627|TWO_SIDED|95.0|0.44|3.61|||Cochran-Mantel-Haenszel|||||3.61|0.44|0.627
72361902|NCT03486912|144235400|SUPERIORITY||Odds Ratio (OR)|1.12||||0.864|TWO_SIDED|95.0|0.4|3.16|||Cochran-Mantel-Haenszel|||||3.16|0.40|0.864
72361903|NCT03486912|144235400|SUPERIORITY||Odds Ratio (OR)|0.85||||0.743|TWO_SIDED|95.0|0.29|2.49|||Cochran-Mantel-Haenszel|||||2.49|0.29|0.743
72361904|NCT03486912|144235400|SUPERIORITY||Odds Ratio (OR)|0.79||||0.63|TWO_SIDED|95.0|0.27|2.29|||Cochran-Mantel-Haenszel|||||2.29|0.27|0.630
72361905|NCT03486912|144235401|SUPERIORITY||Odds Ratio (OR)|1.43||||0.477|TWO_SIDED|95.0|0.48|4.25|||Cochran-Mantel-Haenszel|||||4.25|0.48|0.477
72361906|NCT03486912|144235401|SUPERIORITY||Odds Ratio (OR)|1.04||||0.814|TWO_SIDED|95.0|0.32|3.44|||Cochran-Mantel-Haenszel|||||3.44|0.32|0.814
72361907|NCT03486912|144235401|SUPERIORITY||Odds Ratio (OR)|0.64||||0.367|TWO_SIDED|95.0|0.21|1.93|||Cochran-Mantel-Haenszel|||||1.93|0.21|0.367
72361908|NCT03486912|144235402|SUPERIORITY|||||||0.309|||||||Cochran-Mantel-Haenszel|||||||0.309
72361909|NCT03486912|144235402|SUPERIORITY|||||||0.146|||||||Cochran-Mantel-Haenszel|||||||0.146
72361910|NCT03486912|144235402|SUPERIORITY|||||||0.317|||||||Cochran-Mantel-Haenszel|||||||0.317
72361911|NCT03486912|144235403|SUPERIORITY||Odds Ratio (OR)|6.91||||0.054|TWO_SIDED|95.0|0.76|325.97|||Cochran-Mantel-Haenszel|||||325.97|0.76|0.054
72361912|NCT03486912|144235403|SUPERIORITY||Odds Ratio (OR)|12.21||||0.004|TWO_SIDED|95.0|1.5|549.08|||Cochran-Mantel-Haenszel|||||549.08|1.50|0.004
72361913|NCT03486912|144235403|SUPERIORITY||Odds Ratio (OR)|5.59||||0.087|TWO_SIDED|95.0|0.57|271.11|||Cochran-Mantel-Haenszel|||||271.11|0.57|0.087
72361914|NCT02491684|144235404|SUPERIORITY_OR_OTHER||Ratio of proportions|1.29||||0.645|TWO_SIDED|95.0|0.43|3.85|||log-binomial regression model|The ratio of proportions was calculated by back-transforming the estimated treatment effect.|AZD9412 versus Placebo|Proportions of patients with exacerbations are compared using a log-binomial regression model with treatment group and region as factors.||3.85|0.43|0.645
72361915|NCT02491684|144235405|SUPERIORITY_OR_OTHER||Ratio of proportions|1.97||||0.411|TWO_SIDED|95.0|0.39|9.89|||log-binomial regression model|The ratio of proportions was calculated by back-transforming the estimated treatment effect.|AZD9412 versus Placebo for Days 1 - 7|Proportions of patients with exacerbations are compared using a log-binomial regression model with treatment group and region as factors.||9.89|0.39|0.411
72361916|NCT02491684|144235405|SUPERIORITY_OR_OTHER||Ratio of proportions|1.25||||0.659|TWO_SIDED|95.0|0.46|3.41|||log-binomial regression model|The ratio of proportions was calculated by back-transforming the estimated treatment effect.|AZD9412 versus Placebo for Days 1 - 30|Proportions of patients with exacerbations are compared using a log-binomial regression model with treatment group and region as factors.||3.41|0.46|0.659
72361917|NCT02491684|144235406|SUPERIORITY_OR_OTHER||Ratio of proportions|1.1||||0.944|TWO_SIDED|95.0|0.08|15.79|||log-binomial regression model|The ratio of proportions was calculated by back-transforming the estimated treatment effect.|AZD9412 versus Placebo for Days 1 - 14|Proportions of patients with exacerbations are compared using a log-binomial regression model with treatment group and region as factors.||15.79|0.08|0.944
72361918|NCT02491684|144235406|SUPERIORITY_OR_OTHER||Ratio of proportions|1.1||||0.944|TWO_SIDED|95.0|0.08|15.79|||log-binomial regression model|The ratio of proportions was calculated by back-transforming the estimated treatment effect.|AZD9412 versus Placebo for Days 1 - 30|Proportions of patients with exacerbations are compared using a log-binomial regression model with treatment group and region as factors.||15.79|0.08|0.944
72361919|NCT02491684|144235407|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.3||||0.634|TWO_SIDED|95.0|0.45|3.77|||Regression, Cox|Hazard ratio was calculated adjusting for treatment group and region.|AZD9412 versus Placebo|Analysis of time to first severe exacerbation within 30 days of treatment start.||3.77|0.45|0.634
72361920|NCT02491684|144235408|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.05||||0.973|TWO_SIDED|95.0|0.07|16.78|||Regression, Cox|Hazard ratio was calculated adjusting for treatment group and region.|AZD9412 versus Placebo|Analysis of time to first moderate exacerbation within 30 days of treatment start.||16.78|0.07|0.973
72361921|NCT02491684|144235410|SUPERIORITY_OR_OTHER||Least Squares (LS) Mean difference|0.09||||0.495|TWO_SIDED|95.0|-0.17|0.35|||ANCOVA|Change from baseline is analysed using an Analysis of Covariance (ANCOVA) model with treatment and region as factors and baseline value as covariate.|AZD9412 versus Placebo for change from baseline in total score at Visit 4.|Analysis of change from baseline in total score at Visit 4.||0.35|-0.17|0.495
72361922|NCT02491684|144235410|SUPERIORITY_OR_OTHER||LS Mean Difference|0.06||||0.715|TWO_SIDED|95.0|-0.26|0.38|||ANCOVA|Change from baseline is analysed using an ANCOVA model with treatment and region as factors and baseline value as covariate.|AZD9412 versus Placebo|Analysis of change from baseline in total score at Visit 6.||0.38|-0.26|0.715
72361923|NCT02491684|144235410|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.07||||0.687|TWO_SIDED|95.0|-0.42|0.28|||ANCOVA|Change from baseline is analysed using an ANCOVA model with treatment and region as factors and baseline value as covariate.|AZD9412 versus Placebo|Analysis of change from baseline in total score at Visit 8.||0.28|-0.42|0.687
72361924|NCT02491684|144235411|SUPERIORITY_OR_OTHER||LS Mean difference|0.11||||0.516|TWO_SIDED|95.0|-0.23|0.45|||ANCOVA|AUC for change from baseline is analysed using an ANCOVA model with treatment and region as factors and baseline value as covariate.|AZD9412 versus Placebo|Analysis of AUC for change from baseline in total score over Days 1-14.||0.45|-0.23|0.516
72361925|NCT02491684|144235411|SUPERIORITY_OR_OTHER||LS mean difference|0.11||||0.417|TWO_SIDED|95.0|-0.16|0.37|||ANCOVA|AUC for change from baseline is analysed using an ANCOVA model with treatment and region as factors and baseline value as covariate.|AZD9412 versus Placebo|Analysis of AUC for change from baseline in total score over Days 1-7.||0.37|-0.16|0.417
72361926|NCT02491684|144235411|SUPERIORITY_OR_OTHER||LS mean difference|0.01||||0.954|TWO_SIDED|95.0|-0.34|0.36|||ANCOVA|AUC for change from baseline is analysed using an ANCOVA model with treatment and region as factors and baseline value as covariate.|AZD9412 versus Placebo|Analysis of AUC for change from baseline in total score over Days 8-14.||0.36|-0.34|0.954
72361927|NCT02491684|144235411|SUPERIORITY_OR_OTHER||LS Mean difference|0.0||||0.985|TWO_SIDED|95.0|-0.35|0.35|||ANCOVA|AUC for change from baseline is analysed using an ANCOVA model with treatment and region as factors and baseline value as covariate.|AZD9412 versus Placebo|Analysis of AUC for change from baseline in total score over Days 15-30.||0.35|-0.35|0.985
72361928|NCT02491684|144235413|SUPERIORITY_OR_OTHER||LS Mean difference|-0.07||||0.66|TWO_SIDED|95.0|-0.38|0.24|||ANCOVA|Change from baseline is analysed using an ANCOVA model with treatment and region as factors and baseline value as covariate.|AZD9412 versus Placebo|Analysis of change from baseline in overall score at Visit 6.||0.24|-0.38|0.660
72361929|NCT02491684|144235413|SUPERIORITY_OR_OTHER||LS Mean difference|-0.09||||0.624|TWO_SIDED|95.0|-0.48|0.29|||ANCOVA|Change from baseline is analysed using an ANCOVA model with treatment and region as factors and baseline value as covariate.|AZD9412 versus Placebo|Analysis of change from baseline in overall score at Visit 8.||0.29|-0.48|0.624
72361930|NCT02491684|144235414|SUPERIORITY_OR_OTHER||LS Mean difference|0.54||||0.309|TWO_SIDED|95.0|-0.51|1.59|||ANCOVA|AUC for change from baseline is analysed using an ANCOVA model with treatment and region as factors and baseline value as covariate.|AZD9412 versus Placebo|Analysis of AUC for change from baseline over Days 1-14.||1.59|-0.51|0.309
72361931|NCT02491684|144235415|SUPERIORITY_OR_OTHER||LS Mean difference|16.98||||0.059|TWO_SIDED|95.0|-0.63|34.6|||ANCOVA|Analysis uses an ANCOVA model with treatment, region, gender, and smoking status as factors, and baseline value and height as covariates.|AZD9412 versus Placebo|Analysis of AUC for change from baseline over Days 1-14.||34.60|-0.63|0.059
72361932|NCT02491684|144235415|SUPERIORITY_OR_OTHER||LS Mean difference|19.35||||0.01|TWO_SIDED|95.0|4.66|34.05|||ANCOVA|Analysis uses an ANCOVA model with treatment, region, gender, and smoking status as factors, and baseline value and height as covariates.|AZD9412 versus Placebo|Analysis of AUC for change from baseline over Days 1-7.||34.05|4.66|0.010
72361933|NCT02491684|144235415|SUPERIORITY_OR_OTHER||LS Mean difference|14.38||||0.153|TWO_SIDED|95.0|-5.44|34.2|||ANCOVA|Analysis uses an ANCOVA model with treatment, region, gender, and smoking status as factors, and baseline value and height as covariates.|AZD9412 versus Placebo|Analysis of AUC for change from baseline over Days 8-14.||34.20|-5.44|0.153
72361934|NCT02491684|144235415|SUPERIORITY_OR_OTHER||LS Mean difference|19.26||||0.096|TWO_SIDED|95.0|-3.44|41.97|||ANCOVA|Analysis uses an ANCOVA model with treatment, region, gender, and smoking status as factors, and baseline value and height as covariates.|AZD9412 versus Placebo|Analysis of AUC for change from baseline over Days 15-30.||41.97|-3.44|0.096
72361935|NCT02491684|144235416|SUPERIORITY_OR_OTHER||LS Mean difference|0.07||||0.161|TWO_SIDED|95.0|-0.03|0.17|||ANCOVA|Analysis uses an ANCOVA model with treatment, region, gender, and smoking status as factors, and baseline value and height as covariates.|AZD9412 versus Placebo|Analysis of AUC for change from baseline over Days 1-14.||0.17|-0.03|0.161
72361936|NCT02491684|144235416|SUPERIORITY_OR_OTHER||LS Mean difference|0.08||||0.087|TWO_SIDED|95.0|-0.01|0.17|||ANCOVA|Analysis uses an ANCOVA model with treatment, region, gender, and smoking status as factors, and baseline value and height as covariates.|AZD9412 versus Placebo|Analysis of AUC for change from baseline over Days 1-7.||0.17|-0.01|0.087
72361937|NCT02491684|144235416|SUPERIORITY_OR_OTHER||LS Mean difference|0.06||||0.28|TWO_SIDED|95.0|-0.05|0.16|||ANCOVA|Analysis uses an ANCOVA model with treatment, region, gender, and smoking status as factors, and baseline value and height as covariates.|AZD9412 versus Placebo|Analysis of AUC for change from baseline over Days 8-14.||0.16|-0.05|0.280
72361938|NCT02491684|144235416|SUPERIORITY_OR_OTHER||LS Mean difference|0.11||||0.086|TWO_SIDED|95.0|-0.02|0.24|||ANCOVA|Analysis uses an ANCOVA model with treatment, region, gender, and smoking status as factors, and baseline value and height as covariates.|AZD9412 versus Placebo|Analysis of AUC for change from baseline over Days 15-30.||0.24|-0.02|0.086
72361939|NCT02491684|144235417|SUPERIORITY_OR_OTHER||LS Mean difference|11.69||||0.211|TWO_SIDED|95.0|-6.76|30.14|||ANCOVA|Analysis uses an ANCOVA model with treatment, region, gender, and smoking status as factors, and baseline value and height as covariates.|AZD9412 versus Placebo|Analysis of AUC for change from baseline over Days 1-14.||30.14|-6.76|0.211
72361940|NCT02491684|144235417|SUPERIORITY_OR_OTHER||LS Mean difference|11.19||||0.125|TWO_SIDED|95.0|-3.18|25.56|||ANCOVA|Analysis uses an ANCOVA model with treatment, region, gender, and smoking status as factors, and baseline value and height as covariates.|AZD9412 versus Placebo|Analysis of AUC for change from baseline over Days 1-7.||25.56|-3.18|0.125
72361941|NCT02491684|144235417|SUPERIORITY_OR_OTHER||LS Mean difference|11.14||||0.277|TWO_SIDED|95.0|-9.08|31.36|||ANCOVA|Analysis uses an ANCOVA model with treatment, region, gender, and smoking status as factors, and baseline value and height as covariates.|AZD9412 versus Placebo|Analysis of AUC for change from baseline over Days 8-14.||31.36|-9.08|0.277
72361942|NCT02491684|144235417|SUPERIORITY_OR_OTHER||LS Mean difference|17.13||||0.161|TWO_SIDED|95.0|-6.92|41.18|||ANCOVA|Analysis uses an ANCOVA model with treatment, region, gender, and smoking status as factors, and baseline value and height as covariates.|AZD9412 versus Placebo|Analysis of AUC for change from baseline over Days 15-30.||41.18|-6.92|0.161
72361943|NCT02491684|144235418|SUPERIORITY_OR_OTHER||LS Mean difference|0.06||||0.287|TWO_SIDED|95.0|-0.05|0.16|||ANCOVA|Analysis uses an ANCOVA model with treatment, region, gender, and smoking status as factors, and baseline value and height as covariates.|AZD9412 versus Placebo|Analysis of AUC for change from baseline over Days 1-14.||0.16|-0.05|0.287
72361944|NCT02491684|144235418|SUPERIORITY_OR_OTHER||LS Mean difference|0.04||||0.457|TWO_SIDED|95.0|-0.06|0.14|||ANCOVA|Analysis uses an ANCOVA model with treatment, region, gender, and smoking status as factors, and baseline value and height as covariates.|AZD9412 versus Placebo|Analysis of AUC for change from baseline over Days 1-7.||0.14|-0.06|0.457
72361945|NCT02491684|144235418|SUPERIORITY_OR_OTHER||LS Mean difference|0.05||||0.315|TWO_SIDED|95.0|-0.05|0.16|||ANCOVA|Analysis uses an ANCOVA model with treatment, region, gender, and smoking status as factors, and baseline value and height as covariates.|AZD9412 versus Placebo|Analysis of AUC for change from baseline over Days 8-14.||0.16|-0.05|0.315
72361946|NCT02491684|144235418|SUPERIORITY_OR_OTHER||LS Mean difference|0.09||||0.134|TWO_SIDED|95.0|-0.03|0.22|||ANCOVA|Analysis uses an ANCOVA model with treatment, region, gender, and smoking status as factors, and baseline value and height as covariates.|AZD9412 versus Placebo|Analysis of AUC for change from baseline over Days 15-30.||0.22|-0.03|0.134
72361947|NCT00468169|144235460|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1225||||||Log-rank test comparing PFS between two treatment arms|Log Rank|||||||0.1225
72361948|NCT01283139|144235482|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.71||||0.057|TWO_SIDED|90.0|1.03|2.71|||Regression, Logistic|||||2.71|1.03|0.057
72361949|NCT01283139|144235482|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.6||||0.094|TWO_SIDED|90.0|1.01|2.54|||Regression, Logistic|||||2.54|1.01|0.094
72361950|NCT01283139|144235482|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.84||||0.031|TWO_SIDED|90.0|1.16|2.94|||Regression, Logistic|||||2.94|1.16|0.031
72361951|NCT01283139|144235483|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.88||||0.042|TWO_SIDED|90.0|1.13|3.14|||Regression, Logistic|||||3.14|1.13|0.042
72361952|NCT01283139|144235483|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.41||||0.264|TWO_SIDED|90.0|0.85|2.35|||Regression, Logistic|||||2.35|0.85|0.264
72361953|NCT01283139|144235483|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.91||||0.038|TWO_SIDED|90.0|1.14|3.19|||Regression, Logistic|||||3.19|1.14|0.038
72361954|NCT01283139|144235484|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.19||||0.808|TWO_SIDED|90.0|0.37|3.81|||Regression, Logistic|||||3.81|0.37|0.808
72361955|NCT01283139|144235484|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.45||||0.598|TWO_SIDED|90.0|0.45|4.66|||Regression, Logistic|||||4.66|0.45|0.598
72361956|NCT01283139|144235484|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.9||||0.884|TWO_SIDED|90.0|0.27|3.02|||Regression, Logistic|||||3.02|0.27|0.884
72361957|NCT01283139|144235485|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.92||||0.044|TWO_SIDED|90.0|1.22|7.01|||Regression, Logistic|||||7.01|1.22|0.044
72361958|NCT01283139|144235485|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.4||||0.498|TWO_SIDED|90.0|0.62|3.19|||Regression, Logistic|||||3.19|0.62|0.498
72361959|NCT01283139|144235485|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.03||||0.049|TWO_SIDED|90.0|1.2|7.68|||Regression, Logistic|||||7.68|1.20|0.049
72361960|NCT01283139|144235486|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.39||||0.27|TWO_SIDED|90.0|0.85|2.25|||Regression, Logistic|||||2.25|0.85|0.270
72361961|NCT01283139|144235486|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.69||||0.077|TWO_SIDED|90.0|1.04|2.74|||Regression, Logistic|||||2.74|1.04|0.077
72361962|NCT01283139|144235486|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.25||||0.453|TWO_SIDED|90.0|0.76|2.05|||Regression, Logistic|||||2.05|0.76|0.453
72361963|NCT01614249|144235491|SUPERIORITY_OR_OTHER||Slope|1.01|STANDARD_ERROR_OF_MEAN|0.8||0.21|TWO_SIDED|95.0|-0.58|2.6||The p-value was adjusted for baseline variations in the analysis of covariance (ANCOVA) regression model. The significance level was set at p-value less than 0.05.|ANCOVA|In ANCOVA, fish oil group was main effect, participant baseline variables were covariates and presence of interaction between covariates was tested.||Null hypothesis: There is no difference in the magnitude of change in BDI-II scores between HIV-seropositive pregnant women on fish oil omega-3 EPA-rich supplements and the control group on soybean oil soft gels. A sample size of 91 women per arm gave an 85% power to detect as statistically significant at 5% level, a true difference of 4 scores in the mean depressive symptom scores between the two arms assuming a within group standard deviation of nine in depressive symptom scores.||2.60|-0.58|0.21
72361964|NCT00980954|144235533|SUPERIORITY||Hazard Ratio (HR)|1.05||||0.56|TWO_SIDED|90.0|0.65|1.68||One-sided significance level = 0.05.|Log Rank||Reference level = Arm I|Sample size calculations are based on the primary hypothesis that 4 additional cycles of carboplatin and paclitaxel following concurrent radiation and weekly cisplatin will increase 4-year DFS from 80% to 90% for patients with cervical carcinoma with positive nodes and/or positive margins after a radical hysterectomy. One-sided alpha=0.05, statistical power=80%, 5.5 years of accrual with 4 years of follow-up, 2 interim significance tests. 50 DFS events are required to trigger this analysis.||1.68|0.65|0.56
72361965|NCT00980954|144235534|SUPERIORITY||Hazard Ratio (HR)|0.91||||0.4|TWO_SIDED|90.0|0.49|1.69||One-sided significance level = 0.05.|Log Rank|||The 4-year overall survival rate for the control arm is expected to be approximately 85%. The overall survival will be compared between the two arms. The final targeted sample size of 235 patients with the longer accrual time, will provide 64% and 78% power to detect an increase in overall survival to 92% and 93% respectively, with a 1- sided alpha of 0.05.||1.69|0.49|0.40
72361966|NCT02234843|144235643|OTHER||Hazard Ratio (HR)|0.4||||0.1509|TWO_SIDED|95.0|0.11|1.41|||Expl. Cox Proportional Hazards Model|||||1.41|0.11|0.1509
72361967|NCT02787564|144235678|OTHER||||||<|0.001||||||Comparison of difference of fruit and vegetable variety between intervention group and control group.|Wilcoxon (Mann-Whitney)|||||||<0.001
72361968|NCT02787564|144235679|OTHER|||||||0.038||||||Comparison of difference of fruit and vegetable amount between intervention group and control group.|Wilcoxon (Mann-Whitney)|||||||0.038
72361969|NCT02787564|144235680|OTHER|||||||0.026||||||Comparison of difference of fruit and vegetable variety between intervention group and control group.|Wilcoxon (Mann-Whitney)|||||||0.026
72361970|NCT02787564|144235681|OTHER|||||||0.443||||||Comparison of difference of fruit and vegetable amount between intervention group and control group.|Wilcoxon (Mann-Whitney)|||||||0.443
72361971|NCT02787564|144235682|OTHER|||||||0.006||||||Comparison of difference of fruit and vegetable variety between intervention group and control group.|Wilcoxon (Mann-Whitney)|||||||0.006
72361972|NCT02787564|144235683|OTHER|||||||0.029||||||Comparison of difference of fruit and vegetable amount between intervention group and control group.|Wilcoxon (Mann-Whitney)|||||||0.029
72361973|NCT00498940|144235686|SUPERIORITY_OR_OTHER|||||||0.14||||||Differences in cardiac index between groups were assessed by an independent 2-sample t test.|t-test, 2 sided|||||||.14
72361974|NCT02977403|144235690|SUPERIORITY|Change scores were computed (post-intervention - pre-intervention = delta) for AB reaction time measures. A linear mixed model was run with change scores as the dependent variable. Between-subject factors were condition, recent LOC-eating (0=absent, 1=present), and a condition by LOC-eating interaction term. AB reaction times were nested within subject. Models included a random intercept and were adjusted for stimuli pairing type, age, fat mass, height, and race and ethnicity.|beta coefficient|-1.948|||||TWO_SIDED|95.0|-20.79|16.894||Effect sizes and 95% CIs, rather than statistical significance, were used. Cohen's d was interpreted as minimal to no effect (\<.02) small effect (0.2-0.49) medium effect (0.5-0.79) large effect (0.8).|||To examine changes in AB, change scores were computed (post-pre = delta). Positive scores represent an increase in AB from pre- to post- intervention. Negative ∆reaction time scores represent a decrease in AB from pre- to post- intervention.|Sample size estimation was based on the power analysis for the first hypothesis (examine changes in AB following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||16.894|-20.790|
72361975|NCT02977403|144235690|SUPERIORITY|See Statistical Analysis 1 for details. No p-values supplied, only confidence intervals and Cohen's d|beta coefficient|-0.952|||||TWO_SIDED|95.0|-35.28|33.377||||||Interaction of Loss of Control Eating with attention bias. See Statistical Analysis 1 for details.||33.377|-35.280|
72361976|NCT02977403|144235691|SUPERIORITY|Change scores were computed (post-intervention - pre-intervention = delta) for oscillatory power. A linear mixed model was run with change scores as the dependent variable. Between-subject factors were condition, recent LOC-eating (0=absent, 1=present), and a condition by LOC-eating interaction term. Oscillatory power analyses were nested within subject. Models included a random intercept and were adjusted for stimuli pairing type, age, fat mass, height, and race and ethnicity.|beta coefficent|0.047|||||TWO_SIDED|95.0|-0.025|0.119||Effect sizes and 95% CIs, rather than statistical significance, were used. Cohen's d was interpreted as minimal to no effect (\<.02) small effect (0.2-0.49) medium effect (0.5-0.79) large effect (0.8).|||To examine changes in oscillatory power, change scores were computed (post-pre=delta). Positive scores represent an increase from pre- to post- intervention. Negative scores represent a decrease from pre- to post- intervention.|Sample size estimation was based on the power analysis for the first hypothesis (examine changes in oscillatory power following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||0.119|-0.025|
72361977|NCT02977403|144235691|SUPERIORITY|See Statistical Analysis 1 for details. No p-values supplied, only confidence intervals and Cohen's d|beta coefficient|-0.134|||||TWO_SIDED|95.0|-0.288|0.019||||||Interaction of Loss of Control Eating with attention bias. See Statistical Analysis 1 for details.||0.019|-0.288|
72361978|NCT02977403|144235692|SUPERIORITY|Change scores were computed (post-intervention - pre-intervention = delta) for oscillatory power. A linear mixed model was run with change scores as the dependent variable. Between-subject factors were condition, recent LOC-eating (0=absent, 1=present), and a condition by LOC-eating interaction term. Oscillatory power analyses were nested within subject. Models included a random intercept and were adjusted for stimuli pairing type, age, fat mass and height, race and ethnicity.|beta coefficent|-0.002|||||TWO_SIDED|95.0|-0.085|0.082||Effect sizes and 95% CIs, rather than statistical significance, were used. Cohen's d was interpreted as minimal to no effect (\<.02) small effect (0.2-0.49) medium effect (0.5-0.79) large effect (0.8).|||To examine changes in oscillatory power, change scores were computed (post-pre=delta). Positive scores represent an increase from pre- to post-intervention. Negative scores represent a decrease from pre- to post- intervention.|Sample size estimation was based on the power analysis for the first hypothesis (examine changes in oscillatory power following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||0.082|-0.085|
72361979|NCT02977403|144235692|SUPERIORITY|See Statistical Analysis 1 for details. No p-values supplied, only confidence intervals and Cohen's d|beta coefficient|-0.053|||||TWO_SIDED|95.0|-0.177|0.071||||||Interaction of Loss of Control Eating with attention bias. See Statistical Analysis 1 for details.||0.071|-0.177|
72361980|NCT02977403|144235693|SUPERIORITY|Change scores were computed (post-intervention - pre-intervention = delta) for oscillatory power. A linear mixed model was run with change scores as the dependent variable. Between-subject factors were condition, recent LOC-eating (0=absent, 1=present), and a condition by LOC-eating interaction term. Oscillatory power analyses were nested within subject. Models included a random intercept and were adjusted for stimuli pairing type, age, fat mass, height, and race and ethnicity.|beta coefficient|0.08|||||TWO_SIDED|95.0|-0.022|0.182||Effect sizes and 95% CIs, rather than statistical significance, were used. Cohen's d was interpreted as minimal to no effect (\<.02) small effect (0.2-0.49) medium effect (0.5-0.79) large effect (0.8).|||To examine changes in oscillatory power, change scores were computed (post-pre=delta). Positive scores represent an increase from pre- to post- intervention. Negative scores represent a decrease from pre- to post- intervention.|Sample size estimation was based on the power analysis for the first hypothesis (examine changes in oscillatory power following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||0.182|-0.022|
72361981|NCT02977403|144235693|SUPERIORITY|See Statistical Analysis 1 for details. No p-values supplied, only confidence intervals and Cohen's d|beta coefficient|-0.018|||||TWO_SIDED|95.0|-0.139|0.103||||||Interaction of Loss of Control Eating with attention bias. See Statistical Analysis 1 for details.||0.103|-0.139|
72368393|NCT00298558|144246924|SUPERIORITY_OR_OTHER||Effect Size|-0.05||||0.56|TWO_SIDED|99.0|-0.26|0.16|||Mixed Models Analysis|The blom transformation was used to reduce skewness in the measures. The design factors and baseline covariates were controlled in the model.|Blom transformed outcome was used and the design factors and baseline covariates were controlled in the model to get the adjusted means. After that, the effect size (defined in the Additional details) was calculated using the adjusted means and SD.|Effect size was defined as training improvement from baseline to year 10 minus control improvement from baseline to year 10 divided by the intrasubject standard deviation (SD) of the composite score. Positive effect sizes indicate improvement.||0.16|-0.26|0.56
72368394|NCT02908672|144246925|SUPERIORITY||Hazard Ratio (HR)|0.79||||0.0224|TWO_SIDED|95.0|0.64|0.97|||Log Rank||Stratified Hazard Ratio|||0.97|0.64|0.0224
72368395|NCT02908672|144246926|SUPERIORITY||Hazard Ratio (HR)|0.85||||0.1607|TWO_SIDED|95.0|0.67|1.07|||Log Rank||Stratified Hazard Ratio|||1.07|0.67|0.1607
72361982|NCT02977403|144235694|SUPERIORITY|Change scores were computed (post-intervention - pre-intervention = delta) for oscillatory power. A linear mixed model was run with change scores as the dependent variable. Between-subject factors were condition, recent LOC-eating (0=absent, 1=present), and a condition by LOC-eating interaction term. Oscillatory power analyses were nested within subject. Models included a random intercept and were adjusted for stimuli pairing type, age, fat mass, height, and race and ethnicity.|beta coefficient|0.013|||||TWO_SIDED|95.0|-0.086|0.113||Effect sizes and 95% CIs, rather than statistical significance, were used. Cohen's d was interpreted as minimal to no effect (\<.02) small effect (0.2-0.49) medium effect (0.5-0.79) large effect (0.8).|||To examine changes in oscillatory power, change scores were computed (post-pre=delta). Positive scores represent an increase from pre- to post- intervention. Negative scores represent a decrease from pre- to post- intervention.|Sample size estimation was based on the power analysis for the first hypothesis (examine changes in oscillatory power following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||0.113|-0.086|
72361983|NCT02977403|144235694|SUPERIORITY|See Statistical Analysis 1 for details. No p-values supplied, only confidence intervals and Cohen's d|beta coefficient|-0.035|||||TWO_SIDED|95.0|-0.179|0.109||||||Interaction of Loss of Control Eating with attention bias. See Statistical Analysis 1 for details.||0.109|-0.179|
72361984|NCT02977403|144235695|SUPERIORITY|Change scores were computed (post-intervention - pre-intervention = delta) for oscillatory power. A linear mixed model was run with change scores as the dependent variable. Between-subject factors were condition, recent LOC-eating (0=absent, 1=present), and a condition by LOC-eating interaction term. Oscillatory power analyses were nested within subject. Models included a random intercept and were adjusted for stimuli pairing type, age, fat mass, height, and race and ethnicity.|beta coefficient|0.083|||||TWO_SIDED|95.0|-0.001|0.167||Effect sizes and 95% CIs, rather than statistical significance, were used. Cohen's d was interpreted as minimal to no effect (\<.02) small effect (0.2-0.49) medium effect (0.5-0.79) large effect (0.8).|||To examine changes in oscillatory power, change scores were computed (post-pre=delta). Positive scores represent an increase from pre- to post- intervention. Negative scores represent a decrease from pre- to post- intervention.|Sample size estimation was based on the power analysis for the first hypothesis (examine changes in oscillatory power following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||0.167|-0.001|
72361985|NCT02977403|144235695|SUPERIORITY|See Statistical Analysis 1 for details. No p-values supplied, only confidence intervals and Cohen's d|beta coefficient|-0.069|||||TWO_SIDED|95.0|-0.201|0.063||||||Interaction of Loss of Control Eating with attention bias. See Statistical Analysis 1 for details.||0.063|-0.201|
72361986|NCT02977403|144235696|SUPERIORITY|Change scores were computed (post-intervention - pre-intervention = delta) for oscillatory power. A linear mixed model was run with change scores as the dependent variable. Between-subject factors were condition, recent LOC-eating (0=absent, 1=present), and a condition by LOC-eating interaction term. Oscillatory power analyses were nested within subject. Models included a random intercept and were adjusted for stimuli pairing type, age, fat mass, height, and race and ethnicity|beta coefficient|0.031|||||TWO_SIDED|95.0|-0.059|0.121||Effect sizes and 95% CIs, rather than statistical significance, were used. Cohen's d was interpreted as minimal to no effect (\<.02) small effect (0.2-0.49) medium effect (0.5-0.79) large effect (0.8).|||To examine changes in oscillatory power, change scores were computed (post-pre=delta). Positive scores represent an increase from pre- to post- intervention. Negative scores represent a decrease from pre- to post- intervention.|Sample size estimation was based on the power analysis for the first hypothesis (examine changes in oscillatory power following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||0.121|-0.059|
72361987|NCT02977403|144235696|SUPERIORITY|See Statistical Analysis 1 for details. No p-values supplied, only confidence intervals and Cohen's d|beta coefficient|-0.002|||||TWO_SIDED|95.0|-0.157|0.152||||||Interaction of Loss of Control Eating with attention bias. See Statistical Analysis 1 for details.||0.152|-0.157|
72361988|NCT02977403|144235697|SUPERIORITY|Change scores were computed (post-intervention - pre-intervention = delta) for oscillatory power. A linear mixed model was run with change scores as the dependent variable. Between-subject factors were condition, recent LOC-eating (0=absent, 1=present), and a condition by LOC-eating interaction term. Oscillatory power analyses were nested within subject. Models included a random intercept and were adjusted for stimuli pairing type, age, fat mass, height, and race and ethnicity.|beta coefficient|-0.042|||||TWO_SIDED|95.0|-0.149|0.065||Effect sizes and 95% CIs, rather than statistical significance, were used. Cohen's d was interpreted as minimal to no effect (\<.02) small effect (0.2-0.49) medium effect (0.5-0.79) large effect (0.8).|||To examine changes in oscillatory power, change scores were computed (post-pre=delta). Positive scores represent an increase from pre- to post- intervention. Negative scores represent a decrease from pre- to post- intervention.|Sample size estimation was based on the power analysis for the first hypothesis (examine changes in oscillatory power following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||0.065|-0.149|
72361989|NCT02977403|144235697|SUPERIORITY|See Statistical Analysis 1 for details. No p-values supplied, only confidence intervals and Cohen's d|beta coefficient|-0.068|||||TWO_SIDED|95.0|-0.266|0.131||||||Interaction of Loss of Control Eating with attention bias. See Statistical Analysis 1 for details.||0.131|-0.266|
72368396|NCT02908672|144246927|SUPERIORITY||Difference in response rate|1.63||||0.6997|TWO_SIDED|95.0|-6.9|10.15|||Cochran-Mantel-Haenszel|||||10.15|-6.90|0.6997
72368397|NCT02908672|144246929|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.1191|TWO_SIDED|95.0|0.67|1.05|||Log Rank|||||1.05|0.67|0.1191
72368398|NCT02908672|144246930|SUPERIORITY||Difference in Event Free Rate|8.2||||0.0693|TWO_SIDED|95.0|-0.65|17.04|||Z-test|||||17.04|-0.65|0.0693
72368399|NCT00123422|144246939|SUPERIORITY_OR_OTHER|||||||0.015|TWO_SIDED|||||Statistical tests were 2-sided and a p value of \< 0.05 was the criterion for statistical significance.|ANCOVA|The baseline value was the co-variate in this analysis.||||||0.015
72368400|NCT00123422|144246940|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||ANCOVA|The baseline value was the co-variate in this analysis.||||||<0.05
72368401|NCT03089281|144246941|SUPERIORITY|||||||0.17|||||||Chi-squared|||||||0.17
72368402|NCT03089281|144246942|SUPERIORITY|||||||0.011|||||||t-test, 2 sided|||||||0.011
72368403|NCT03089281|144246943|SUPERIORITY|||||||0.029|||||||t-test, 2 sided|||||||0.029
72361990|NCT02977403|144235698|SUPERIORITY|Change scores were computed (post-intervention - pre-intervention = delta) for oscillatory power. A linear mixed model was run with change scores as the dependent variable. Between-subject factors were condition, recent LOC-eating (0=absent, 1=present), and a condition by LOC-eating interaction term. Oscillatory power analyses were nested within subject. Models included a random intercept and were adjusted for stimuli pairing type, age, fat mass, height, and race and ethnicity.|beta coefficient|-0.034|||||TWO_SIDED|95.0|-0.122|0.053||Effect sizes and 95% CIs, rather than statistical significance, were used. Cohen's d was interpreted as minimal to no effect (\<.02) small effect (0.2-0.49) medium effect (0.5-0.79) large effect (0.8).|||To examine changes in oscillatory power, change scores were computed (post-pre=delta). Positive scores represent an increase from pre- to post- intervention. Negative scores represent a decrease from pre- to post- intervention.|Sample size estimation was based on the power analysis for the first hypothesis (examine changes in oscillatory power following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||0.053|-0.122|
72361991|NCT02977403|144235698|SUPERIORITY|See Statistical Analysis 1 for details. No p-values supplied, only confidence intervals and Cohen's d|beta coefficient|-0.07|||||TWO_SIDED|95.0|-0.233|0.092||||||Interaction of Loss of Control Eating with attention bias. See Statistical Analysis 1 for details.||0.092|-0.233|
72361992|NCT02977403|144235699|SUPERIORITY|Change scores were computed (post-intervention - pre-intervention = delta) for oscillatory power. A linear mixed model was run with change scores as the dependent variable. Between-subject factors were condition, recent LOC-eating (0=absent, 1=present), and a condition by LOC-eating interaction term. Oscillatory power analyses were nested within subject. Models included a random intercept and were adjusted for stimuli pairing type, age, fat mass, height, and race and ethnicity.|beta coefficient|0.042|||||TWO_SIDED|95.0|-0.041|0.126||Effect sizes and 95% CIs, rather than statistical significance, were used. Cohen's d was interpreted as minimal to no effect (\<.02) small effect (0.2-0.49) medium effect (0.5-0.79) large effect (0.8).|||To examine changes in oscillatory power, change scores were computed (post-pre=delta). Positive scores represent an increase from pre- to post- intervention. Negative scores represent a decrease from pre- to post- intervention.|Sample size estimation was based on the power analysis for the first hypothesis (examine changes in oscillatory power following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||0.126|-0.041|
72361993|NCT02977403|144235699|SUPERIORITY|See Statistical Analysis 1 for details. No p-values supplied, only confidence intervals and Cohen's d|beta coefficient|-0.085|||||TWO_SIDED|95.0|-0.252|0.082||||||Interaction of Loss of Control Eating with attention bias. See Statistical Analysis 1 for details.||0.082|-0.252|
72361994|NCT02977403|144235700|SUPERIORITY|Change scores were computed (post-intervention - pre-intervention = delta) for oscillatory power. A linear mixed model was run with change scores as the dependent variable. Between-subject factors were condition, recent LOC-eating (0=absent, 1=present), and a condition by LOC-eating interaction term. Oscillatory power analyses were nested within subject. Models included a random intercept and were adjusted for stimuli pairing type, age, fat mass, height, and race and ethnicity.|beta coefficient|0.021|||||TWO_SIDED|95.0|-0.06|0.102||Effect sizes and 95% CIs, rather than statistical significance, were used. Cohen's d was interpreted as minimal to no effect (\<.02) small effect (0.2-0.49) medium effect (0.5-0.79) large effect (0.8).|||To examine changes in oscillatory power, change scores were computed (post-pre=delta). Positive scores represent an increase from pre- to post- intervention. Negative scores represent a decrease from pre- to post- intervention.|Sample size estimation was based on the power analysis for the first hypothesis (examine changes in oscillatory power following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||0.102|-0.060|
72361995|NCT02977403|144235700|SUPERIORITY|See Statistical Analysis 1 for details. No p-values supplied, only confidence intervals and Cohen's d|beta coefficient|-0.071|||||TWO_SIDED|95.0|-0.26|0.119||||||Interaction of Loss of Control Eating with attention bias. See Statistical Analysis 1 for details.||0.119|-0.260|
72361996|NCT02977403|144235701|SUPERIORITY|Change scores were computed (post-intervention - pre-intervention = delta) for oscillatory power. A linear mixed model was run with change scores as the dependent variable. Between-subject factors were condition, recent LOC-eating (0=absent, 1=present), and a condition by LOC-eating interaction term. Oscillatory power analyses were nested within subject. Models included a random intercept and were adjusted for stimuli pairing type, age, fat mass, height, and race and ethnicity.|beta coefficient|0.107|||||TWO_SIDED|95.0|0.03|0.185||Effect sizes and 95% CIs, rather than statistical significance, were used. Cohen's d was interpreted as minimal to no effect (\<.02) small effect (0.2-0.49) medium effect (0.5-0.79) large effect (0.8).|||To examine changes in oscillatory power, change scores were computed (post-pre=delta). Positive scores represent an increase from pre- to post- intervention. Negative scores represent a decrease from pre- to post- intervention.|Sample size estimation was based on the power analysis for the first hypothesis (examine changes in oscillatory power following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||0.185|0.030|
72361997|NCT02977403|144235701|SUPERIORITY|See Statistical Analysis 1 for details. No p-values supplied, only confidence intervals and Cohen's d|beta coefficient|-0.197|||||TWO_SIDED|95.0|-0.346|-0.047||||||Interaction of Loss of Control Eating with attention bias. See Statistical Analysis 1 for details.||-0.047|-0.346|
72368404|NCT03089281|144246945|SUPERIORITY|||||||0.05|||||||t-test, 2 sided|||||||0.050
72368405|NCT03089281|144246946|SUPERIORITY|||||||0.49|||||||Cochran-Armitage Trend Test|||||||0.49
72368406|NCT03089281|144246947|SUPERIORITY|||||||0.36|||||||t-test, 2 sided|||||||0.36
72368407|NCT03089281|144246948|SUPERIORITY|||||||0.21|||||||t-test, 2 sided|||||||0.21
72368408|NCT03089281|144246949|SUPERIORITY|||||||0.34|||||||t-test, 2 sided|||||||0.34
72368409|NCT03089281|144246950|SUPERIORITY|||||||0.46|||||||t-test, 2 sided|||||||0.46
72368410|NCT03089281|144246951|SUPERIORITY|||||||0.45|||||||t-test, 2 sided|||||||0.45
72368411|NCT03089281|144246952|SUPERIORITY|||||||0.9|||||||t-test, 2 sided|||||||0.90
72368412|NCT03089281|144246953|SUPERIORITY|||||||0.59|||||||t-test, 2 sided|||||||0.59
72368413|NCT01255436|144246954|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.2||||0.06|TWO_SIDED|95.0|-9.4|1.0||p-value\<0.05 is considered significant|t-test, 1 sided|||||1.0|-9.4|0.06
72361998|NCT02977403|144235702|SUPERIORITY|Change scores were computed (post-intervention - pre-intervention = delta) for oscillatory power. A linear mixed model was run with change scores as the dependent variable. Between-subject factors were condition, recent LOC-eating (0=absent, 1=present), and a condition by LOC-eating interaction term. Oscillatory power analyses were nested within subject. Models included a random intercept and were adjusted for stimuli pairing type, age, fat mass, height, and race and ethnicity.|beta coefficient|0.092|||||TWO_SIDED|95.0|0.01|0.175||Effect sizes and 95% CIs, rather than statistical significance, were used. Cohen's d was interpreted as minimal to no effect (\<.02) small effect (0.2-0.49) medium effect (0.5-0.79) large effect (0.8).|||To examine changes in oscillatory power, change scores were computed (post-pre=delta). Positive scores represent an increase from pre- to post- intervention. Negative scores represent a decrease from pre- to post- intervention.|Sample size estimation was based on the power analysis for the first hypothesis (examine changes in oscillatory power following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||0.175|0.010|
72361999|NCT02977403|144235702|SUPERIORITY|See Statistical Analysis 1 for details. No p-values supplied, only confidence intervals and Cohen's d|beta coefficient|-0.049|||||TWO_SIDED|95.0|-0.204|0.107||||||Interaction of Loss of Control Eating with attention bias. See Statistical Analysis 1 for details.||0.107|-0.204|
72362000|NCT02977403|144235703|SUPERIORITY|Change scores were computed (post-intervention - pre-intervention = delta) for oscillatory power. A linear mixed model was run with change scores as the dependent variable. Between-subject factors were condition, recent LOC-eating (0=absent, 1=present), and a condition by LOC-eating interaction term. Oscillatory power analyses were nested within subject. Models included a random intercept and were adjusted for stimuli pairing type, age, fat mass, height, and race and ethnicity.|beta coefficient|0.046|||||TWO_SIDED|95.0|-0.032|0.123||Effect sizes and 95% CIs, rather than statistical significance, were used. Cohen's d was interpreted as minimal to no effect (\<.02) small effect (0.2-0.49) medium effect (0.5-0.79) large effect (0.8).|||To examine changes in oscillatory power, change scores were computed (post-pre=delta). Positive scores represent an increase from pre- to post- intervention. Negative scores represent a decrease from pre- to post- intervention.|Sample size estimation was based on the power analysis for the first hypothesis (examine changes in oscillatory power following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||0.123|-0.032|
72362001|NCT02977403|144235703|SUPERIORITY|See Statistical Analysis 1 for details. No p-values supplied, only confidence intervals and Cohen's d|beta coefficient|0.007|||||TWO_SIDED|95.0|-0.163|0.177||||||Interaction of Loss of Control Eating with attention bias. See Statistical Analysis 1 for details.||0.177|-0.163|
72362002|NCT02977403|144235704|SUPERIORITY|Change scores were computed (post-intervention - pre-intervention = delta) for oscillatory power. A linear mixed model was run with change scores as the dependent variable. Between-subject factors were condition, recent LOC-eating (0=absent, 1=present), and a condition by LOC-eating interaction term. Oscillatory power analyses were nested within subject. Models included a random intercept and were adjusted for stimuli pairing type, age, fat mass, height, and race and ethnicity.|beta coefficient|0.041|||||TWO_SIDED|95.0|-0.03|0.112||Effect sizes and 95% CIs, rather than statistical significance, were used. Cohen's d was interpreted as minimal to no effect (\<.02) small effect (0.2-0.49) medium effect (0.5-0.79) large effect (0.8).|||To examine changes in oscillatory power, change scores were computed (post-pre=delta). Positive scores represent an increase from pre- to post- intervention. Negative scores represent a decrease from pre- to post- intervention.|Sample size estimation was based on the power analysis for the first hypothesis (examine changes in oscillatory power following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||0.112|-0.03|
72362003|NCT02977403|144235704|SUPERIORITY|See Statistical Analysis 1 for details. No p-values supplied, only confidence intervals and Cohen's d|beta coefficient|-0.014|||||TWO_SIDED|95.0|-0.168|0.14||||||Interaction of Loss of Control Eating with attention bias. See Statistical Analysis 1 for details.||0.140|-0.168|
72362004|NCT02977403|144235705|SUPERIORITY|Change scores were computed (post-intervention - pre-intervention = delta) for oscillatory power. A linear mixed model was run with change scores as the dependent variable. Between-subject factors were condition, recent LOC-eating (0=absent, 1=present), and a condition by LOC-eating interaction term. Oscillatory power analyses were nested within subject. Models included a random intercept and were adjusted for stimuli pairing type, age, fat mass, height, and race and ethnicity.|beta coefficient|-0.037|||||TWO_SIDED|95.0|-0.125|0.052||Effect sizes and 95% CIs, rather than statistical significance, were used. Cohen's d was interpreted as minimal to no effect (\<.02) small effect (0.2-0.49) medium effect (0.5-0.79) large effect (0.8).|||To examine changes in oscillatory power, change scores were computed (post-pre=delta). Positive scores represent an increase from pre- to post- intervention. Negative scores represent a decrease from pre- to post- intervention.|Sample size estimation was based on the power analysis for the first hypothesis (examine changes in oscillatory power following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||0.052|-0.125|
72362005|NCT02977403|144235705|SUPERIORITY|See Statistical Analysis 1 for details. No p-values supplied, only confidence intervals and Cohen's d|beta coefficient|-0.034|||||TWO_SIDED|95.0|-0.196|0.129||||||Interaction of Loss of Control Eating with attention bias. See Statistical Analysis 1 for details.||0.129|-0.196|
72368414|NCT01255436|144246955|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.5||||0.14|TWO_SIDED|95.0|-4.1|1.3||p-value \< 0.05 considered significant|t-test, 1 sided|||||1.3|-4.1|0.14
72368415|NCT01255436|144246956|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.3||||0.045|TWO_SIDED|95.0|1.0|1.6|||Fisher Exact||Numerator is Treatment Group (SMS reminders) and Denominator is Control Group (No SMS reminders)|||1.6|1.0|0.045
72368416|NCT01255436|144246957|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.3||||0.014|TWO_SIDED|95.0|1.04|1.53|||Fisher Exact|||||1.53|1.04|0.014
72368417|NCT00826462|144246979|OTHER||||||<|0.01|||||||linear generalized estimating equations||||A linear GEE regression model adjusted for the significant covariates at p \< 0.05 from the univariate GEE logistic regression models calculated for success|||<0.01
72368418|NCT00826462|144246979|OTHER||||||<|0.01|||||||linear generalized estimating equations|||||||<0.01
72362006|NCT02977403|144235706|SUPERIORITY|Change scores were computed (post-intervention - pre-intervention = delta) for oscillatory power. A linear mixed model was run with change scores as the dependent variable. Between-subject factors were condition, recent LOC-eating (0=absent, 1=present), and a condition by LOC-eating interaction term. Oscillatory power analyses were nested within subject. Models included a random intercept and were adjusted for stimuli pairing type, age, fat mass, height, and race and ethnicity.|beta coefficient|0.001|||||TWO_SIDED|95.0|-0.091|0.093||Effect sizes and 95% CIs, rather than statistical significance, were used. Cohen's d was interpreted as minimal to no effect (\<.02) small effect (0.2-0.49) medium effect (0.5-0.79) large effect (0.8).|||To examine changes in oscillatory power, change scores were computed (post-pre=delta). Positive scores represent an increase from pre- to post- intervention. Negative scores represent a decrease from pre- to post- intervention.|Sample size estimation was based on the power analysis for the first hypothesis (examine changes in oscillatory power following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||0.093|-0.091|
72362007|NCT02977403|144235706|SUPERIORITY|See Statistical Analysis 1 for details. No p-values supplied, only confidence intervals and Cohen's d|beta coefficient|-0.143|||||TWO_SIDED|95.0|-0.286|0.001||||||Interaction of Loss of Control Eating with attention bias. See Statistical Analysis 1 for details.||0.001|-0.286|
72362008|NCT02977403|144235707|SUPERIORITY|Change scores were computed (post-intervention - pre-intervention = delta) for oscillatory power. A linear mixed model was run with change scores as the dependent variable. Between-subject factors were condition, recent LOC-eating (0=absent, 1=present), and a condition by LOC-eating interaction term. Oscillatory power analyses were nested within subject. Models included a random intercept and were adjusted for stimuli pairing type, age, fat mass, height, and race and ethnicity.|beta coefficient|0.065|||||TWO_SIDED|95.0|-0.001|0.132||Effect sizes and 95% CIs, rather than statistical significance, were used. Cohen's d was interpreted as minimal to no effect (\<.02) small effect (0.2-0.49) medium effect (0.5-0.79) large effect (0.8).|||To examine changes in oscillatory power, change scores were computed (post-pre=delta). Positive scores represent an increase from pre- to post- intervention. Negative scores represent a decrease from pre- to post- intervention.|Sample size estimation was based on the power analysis for the first hypothesis (examine changes in oscillatory power following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||0.132|-0.001|
72362009|NCT02977403|144235707|SUPERIORITY|See Statistical Analysis 1 for details. No p-values supplied, only confidence intervals and Cohen's d|beta coefficient|-0.095|||||TWO_SIDED|95.0|-0.246|0.055||||||Interaction of Loss of Control Eating with attention bias. See Statistical Analysis 1 for details.||0.055|-0.246|
72362010|NCT02977403|144235708|SUPERIORITY|Change scores were computed (post-intervention - pre-intervention = delta) for oscillatory power. A linear mixed model was run with change scores as the dependent variable. Between-subject factors were condition, recent LOC-eating (0=absent, 1=present), and a condition by LOC-eating interaction term. Oscillatory power analyses were nested within subject. Models included a random intercept and were adjusted for stimuli pairing type, age, fat mass, height, and race and ethnicity.|beta coefficient|0.023|||||TWO_SIDED|95.0|-0.055|0.101||Effect sizes and 95% CIs, rather than statistical significance, were used. Cohen's d was interpreted as minimal to no effect (\<.02) small effect (0.2-0.49) medium effect (0.5-0.79) large effect (0.8).|||To examine changes in oscillatory power, change scores were computed (post-pre=delta). Positive scores represent an increase from pre- to post- intervention. Negative scores represent a decrease from pre- to post- intervention.|Sample size estimation was based on the power analysis for the first hypothesis (examine changes in oscillatory power following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||0.101|-0.055|
72362011|NCT02977403|144235708|SUPERIORITY|See Statistical Analysis 1 for details. No p-values supplied, only confidence intervals and Cohen's d|beta coefficient|-0.02|||||TWO_SIDED|95.0|-0.178|0.137||||||Interaction of Loss of Control Eating with attention bias. See Statistical Analysis 1 for details.||0.137|-0.178|
72362012|NCT02977403|144235709|SUPERIORITY|Change scores were computed (post-intervention - pre-intervention = delta) for oscillatory power. A linear mixed model was run with change scores as the dependent variable. Between-subject factors were condition, recent LOC-eating (0=absent, 1=present), and a condition by LOC-eating interaction term. Oscillatory power analyses were nested within subject. Models included a random intercept and were adjusted for stimuli pairing type, age, fat mass, height, and race and ethnicity.|beta coefficient|-0.032|||||TWO_SIDED|95.0|-0.116|0.051||Effect sizes and 95% CIs, rather than statistical significance, were used. Cohen's d was interpreted as minimal to no effect (\<.02) small effect (0.2-0.49) medium effect (0.5-0.79) large effect (0.8).|||To examine changes in oscillatory power, change scores were computed (post-pre=delta). Positive scores represent an increase from pre- to post- intervention. Negative scores represent a decrease from pre- to post- intervention.|Sample size estimation was based on the power analysis for the first hypothesis (examine changes in oscillatory power following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||0.051|-0.116|
72362013|NCT02977403|144235709|SUPERIORITY|See Statistical Analysis 1 for details. No p-values supplied, only confidence intervals and Cohen's d|beta coefficient|0.06|||||TWO_SIDED|95.0|-0.104|0.223||||||Interaction of Loss of Control Eating with attention bias. See Statistical Analysis 1 for details.||0.223|-0.104|
72368419|NCT00826462|144246983|OTHER||||||||||||||||||linear generalized estimating equations (GEE) regression model adjusted for significant covariates; between groups estimated odds ratio (OR) for no pain on two isometric movements using logistic GEE regression model adjusted for significant covariates; 99 % confidence intervals|||
72368420|NCT01864603|144247008|OTHER||Risk Ratio (RR)|0.95|||||TWO_SIDED|95.0|0.77|1.17||||||Comparison of Phase 1 arms||1.17|0.77|
72368421|NCT01864603|144247009|OTHER||Rate ratio|0.26|||||TWO_SIDED|95.0|0.09|0.75||||||||0.75|0.09|
72368422|NCT01554241|144247032|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANOVA|Results presented were Bonferonni-corrected for a mid-point safety analysis||Comparisons of concentrations in D3 dosing groups at study end were made by ANOVA. Adherence of 80% was pre-specified for inclusion in analyses. .||||<.0001
72368423|NCT01554241|144247032|SUPERIORITY_OR_OTHER||||||=|0.56|TWO_SIDED||||||ANOVA|Bonferroni/Dunn adjustment||||||=.56
72368424|NCT01554241|144247032|SUPERIORITY_OR_OTHER||||||<|0.0009|TWO_SIDED||||||ANOVA|Bonferroni/Dunn adjustment||||||<.0009
72362014|NCT02977403|144235710|SUPERIORITY|Change scores were computed (post-intervention - pre-intervention = delta) for oscillatory power. A linear mixed model was run with change scores as the dependent variable. Between-subject factors were condition, recent LOC-eating (0=absent, 1=present), and a condition by LOC-eating interaction term. Oscillatory power analyses were nested within subject. Models included a random intercept and were adjusted for stimuli pairing type, age, fat mass, height, and race and ethnicity.|beta coefficient|-0.012|||||TWO_SIDED|95.0|-0.078|0.053||Effect sizes and 95% CIs, rather than statistical significance, were used. Cohen's d was interpreted as minimal to no effect (\<.02) small effect (0.2-0.49) medium effect (0.5-0.79) large effect (0.8).|||To examine changes in oscillatory power, change scores were computed (post-pre=delta). Positive scores represent an increase from pre- to post- intervention. Negative scores represent a decrease from pre- to post- intervention.|Sample size estimation was based on the power analysis for the first hypothesis (examine changes in oscillatory power following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||0.053|-0.078|
72362015|NCT02977403|144235710|SUPERIORITY|See Statistical Analysis 1 for details. No p-values supplied, only confidence intervals and Cohen's d|beta coefficient|-0.064|||||TWO_SIDED|95.0|-0.248|0.12||||||Interaction of Loss of Control Eating with attention bias. See Statistical Analysis 1 for details.||0.120|-0.248|
72362016|NCT02977403|144235711|SUPERIORITY|Change scores were computed (post-intervention - pre-intervention = delta) for oscillatory power. A linear mixed model was run with change scores as the dependent variable. Between-subject factors were condition, recent LOC-eating (0=absent, 1=present), and a condition by LOC-eating interaction term. Oscillatory power analyses were nested within subject. Models included a random intercept and were adjusted for stimuli pairing type, age, fat mass, height, and race and ethnicity.|beta coefficient|0.089|||||TWO_SIDED|95.0|0.004|0.174||Effect sizes and 95% CIs, rather than statistical significance, were used. Cohen's d was interpreted as minimal to no effect (\<.02) small effect (0.2-0.49) medium effect (0.5-0.79) large effect (0.8).|||To examine changes in oscillatory power, change scores were computed (post-pre=delta). Positive scores represent an increase from pre- to post- intervention. Negative scores represent a decrease from pre- to post- intervention.|Sample size estimation was based on the power analysis for the first hypothesis (examine changes in oscillatory power following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||0.174|0.004|
72362017|NCT02977403|144235711|SUPERIORITY|See Statistical Analysis 1 for details. No p-values supplied, only confidence intervals and Cohen's d|beta coefficient|0.021|||||TWO_SIDED|95.0|-0.159|0.201||||||Interaction of Loss of Control Eating with attention bias. See Statistical Analysis 1 for details.||0.201|-0.159|
72362018|NCT02977403|144235712|SUPERIORITY|Change scores were computed (post-intervention - pre-intervention = delta) for oscillatory power. A linear mixed model was run with change scores as the dependent variable. Between-subject factors were condition, recent LOC-eating (0=absent, 1=present), and a condition by LOC-eating interaction term. Oscillatory power analyses were nested within subject. Models included a random intercept and were adjusted for stimuli pairing type, age, fat mass, height, and race and ethnicity.|beta coefficient|-0.016|||||TWO_SIDED|95.0|-0.113|0.081||Effect sizes and 95% CIs, rather than statistical significance, were used. Cohen's d was interpreted as minimal to no effect (\<.02) small effect (0.2-0.49) medium effect (0.5-0.79) large effect (0.8).|||To examine changes in oscillatory power, change scores were computed (post-pre=delta). Positive scores represent an increase from pre- to post- intervention. Negative scores represent a decrease from pre- to post- intervention.|Sample size estimation was based on the power analysis for the first hypothesis (examine changes in oscillatory power following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||0.081|-0.113|
72362019|NCT02977403|144235712|SUPERIORITY|See Statistical Analysis 1 for details. No p-values supplied, only confidence intervals and Cohen's d|beta coefficient|-0.072|||||TWO_SIDED|95.0|-0.206|0.062||||||Interaction of Loss of Control Eating with attention bias. See Statistical Analysis 1 for details.||0.062|-0.206|
72362020|NCT02977403|144235713|SUPERIORITY|Change scores were computed (post-intervention - pre-intervention = delta) for oscillatory power. A linear mixed model was run with change scores as the dependent variable. Between-subject factors were condition, recent LOC-eating (0=absent, 1=present), and a condition by LOC-eating interaction term. Oscillatory power analyses were nested within subject. Models included a random intercept and were adjusted for stimuli pairing type, age, fat mass, height, and race and ethnicity.|beta coefficient|0.129|||||TWO_SIDED|95.0|0.049|0.209||Effect sizes and 95% CIs, rather than statistical significance, were used. Cohen's d was interpreted as minimal to no effect (\<.02) small effect (0.2-0.49) medium effect (0.5-0.79) large effect (0.8).|||To examine changes in oscillatory power, change scores were computed (post-pre=delta). Positive scores represent an increase from pre- to post- intervention. Negative scores represent a decrease from pre- to post- intervention.|Sample size estimation was based on the power analysis for the first hypothesis (examine changes in oscillatory power following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||0.209|0.049|
72362021|NCT02977403|144235713|SUPERIORITY|See Statistical Analysis 1 for details. No p-values supplied, only confidence intervals and Cohen's d|beta coefficient|-0.181|||||TWO_SIDED|95.0|-0.33|-0.033||||||Interaction of Loss of Control Eating with attention bias. See Statistical Analysis 1 for details.||-0.033|-0.330|
72368425|NCT01554241|144247032|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANOVA|Bonferroni/Dunn adjustment||||||<.0001
72368426|NCT01554241|144247032|SUPERIORITY_OR_OTHER||||||<|0.006|TWO_SIDED||||||ANOVA|Bonferroni/Dunn adjustment||||||<.006
72368427|NCT01554241|144247032|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANOVA|Bonferroni/Dunn adjustment||||||<.0001
72368428|NCT01554241|144247032|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANOVA|Bonferroni/Dunn adjustment||||||<.0001
72368429|NCT01554241|144247033|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||analyses were corrected for multiple comparisons (Bonferroni)|ANOVA|||||||<.0001
72368430|NCT01554241|144247033|SUPERIORITY_OR_OTHER||||||=|0.47|TWO_SIDED||||||ANOVA|Bonferroni/Dunn adjustment||||||=0.47
72368431|NCT01554241|144247033|SUPERIORITY_OR_OTHER||||||<|0.002|TWO_SIDED||||||ANOVA|Bonferroni/Dunn adjustment||||||<.002
72368432|NCT01554241|144247033|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANOVA|Bonferroni/Dunn adjustment||||||<.0001
72362022|NCT02977403|144235714|SUPERIORITY|Change scores were computed (post-intervention - pre-intervention = delta) for oscillatory power. A linear mixed model was run with change scores as the dependent variable. Between-subject factors were condition, recent LOC-eating (0=absent, 1=present), and a condition by LOC-eating interaction term. Oscillatory power analyses were nested within subject. Models included a random intercept and were adjusted for stimuli pairing type, age, fat mass, height, and race and ethnicity.|beta coefficient|0.126|||||TWO_SIDED|95.0|0.045|0.207||Effect sizes and 95% CIs, rather than statistical significance, were used. Cohen's d was interpreted as minimal to no effect (\<.02) small effect (0.2-0.49) medium effect (0.5-0.79) large effect (0.8).|||To examine changes in oscillatory power, change scores were computed (post-pre=delta). Positive scores represent an increase from pre- to post- intervention. Negative scores represent a decrease from pre- to post- intervention.|Sample size estimation was based on the power analysis for the first hypothesis (examine changes in oscillatory power following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||0.207|0.045|
72362023|NCT02977403|144235714|SUPERIORITY|See Statistical Analysis 1 for details. No p-values supplied, only confidence intervals and Cohen's d|beta coefficient|-0.056|||||TWO_SIDED|95.0|-0.223|0.112||||||Interaction of Loss of Control Eating with attention bias. See Statistical Analysis 1 for details.||0.112|-0.223|
72362024|NCT02977403|144235715|SUPERIORITY|Change scores were computed (post-intervention - pre-intervention = delta) for oscillatory power. A linear mixed model was run with change scores as the dependent variable. Between-subject factors were condition, recent LOC-eating (0=absent, 1=present), and a condition by LOC-eating interaction term. Oscillatory power analyses were nested within subject. Models included a random intercept and were adjusted for stimuli pairing type, age, fat mass, height, and race and ethnicity.|beta coefficient|0.115|||||TWO_SIDED|95.0|0.027|0.203||Effect sizes and 95% CIs, rather than statistical significance, were used. Cohen's d was interpreted as minimal to no effect (\<.02) small effect (0.2-0.49) medium effect (0.5-0.79) large effect (0.8).|||To examine changes in oscillatory power, change scores were computed (post-pre=delta). Positive scores represent an increase from pre- to post- intervention. Negative scores represent a decrease from pre- to post- intervention.|Sample size estimation was based on the power analysis for the first hypothesis (examine changes in oscillatory power following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||0.203|0.027|
72362025|NCT02977403|144235715|SUPERIORITY|See Statistical Analysis 1 for details. No p-values supplied, only confidence intervals and Cohen's d|beta coefficient|-0.058|||||TWO_SIDED|95.0|-0.203|0.087||||||Interaction of Loss of Control Eating with attention bias. See Statistical Analysis 1 for details.||0.087|-0.203|
72362026|NCT02977403|144235716|SUPERIORITY|Change scores were computed (post-intervention - pre-intervention = delta) for oscillatory power. A linear mixed model was run with change scores as the dependent variable. Between-subject factors were condition, recent LOC-eating (0=absent, 1=present), and a condition by LOC-eating interaction term. Oscillatory power analyses were nested within subject. Models included a random intercept and were adjusted for stimuli pairing type, age, fat mass, height, and race and ethnicity.|beta coefficient|0.037|||||TWO_SIDED|95.0|-0.053|0.127||Effect sizes and 95% CIs, rather than statistical significance, were used. Cohen's d was interpreted as minimal to no effect (\<.02) small effect (0.2-0.49) medium effect (0.5-0.79) large effect (0.8).|||To examine changes in oscillatory power, change scores were computed (post-pre=delta). Positive scores represent an increase from pre- to post- intervention. Negative scores represent a decrease from pre- to post- intervention.|Sample size estimation was based on the power analysis for the first hypothesis (examine changes in oscillatory power following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||0.127|-0.053|
72362027|NCT02977403|144235716|SUPERIORITY|See Statistical Analysis 1 for details. No p-values supplied, only confidence intervals and Cohen's d|beta coefficient|-0.085|||||TWO_SIDED|95.0|-0.24|0.069||||||Interaction of Loss of Control Eating with attention bias. See Statistical Analysis 1 for details.||0.069|-0.240|
72362028|NCT02977403|144235717|SUPERIORITY|Change scores were computed (post-intervention - pre-intervention = delta) for oscillatory power. A linear mixed model was run with change scores as the dependent variable. Between-subject factors were condition, recent LOC-eating (0=absent, 1=present), and a condition by LOC-eating interaction term. Oscillatory power analyses were nested within subject. Models included a random intercept and were adjusted for stimuli pairing type, age, fat mass, height, and race and ethnicity.|beta coefficient|-0.021|||||TWO_SIDED|95.0|-0.092|0.05||Effect sizes and 95% CIs, rather than statistical significance, were used. Cohen's d was interpreted as minimal to no effect (\<.02) small effect (0.2-0.49) medium effect (0.5-0.79) large effect (0.8).|||To examine changes in oscillatory power, change scores were computed (post-pre=delta). Positive scores represent an increase from pre- to post- intervention. Negative scores represent a decrease from pre- to post- intervention.|Sample size estimation was based on the power analysis for the first hypothesis (examine changes in oscillatory power following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||0.050|-0.092|
72362029|NCT02977403|144235717|SUPERIORITY|See Statistical Analysis 1 for details. No p-values supplied, only confidence intervals and Cohen's d|beta coefficient|-0.096|||||TWO_SIDED|95.0|-0.249|0.056||||||Interaction of Loss of Control Eating with attention bias. See Statistical Analysis 1 for details.||0.056|-0.249|
72368433|NCT01554241|144247033|SUPERIORITY_OR_OTHER||||||<|0.02|TWO_SIDED||||||ANOVA|Bonferroni/Dunn adjustment||||||<.02
72368434|NCT01554241|144247033|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANOVA|Bonferroni/Dunn adjustment||||||<.0001
72368435|NCT01554241|144247033|SUPERIORITY_OR_OTHER||||||<|0.0003|TWO_SIDED||||||ANOVA|Bonferroni/Dunn adjustment||||||<.0003
72368436|NCT05814367|144247053|NON_INFERIORITY|A non-inferiority margin of 0.05 logMAR was used.|Least-square Mean Difference|-0.005|STANDARD_ERROR_OF_MEAN|0.01|||TWO_SIDED|95.0|-0.025|0.014|||Linear Mixed Model|Kenward and Roger Method was used for the denominator degrees of freedom.|Mean difference was calculated as Test minus Control|The sample size of 38 was calculated to provide at least 90% statistical power to test Non-inferiority of the Test lens compared to the Control lens using a paired t-test with a two-sided type I error rate of 5%.||0.014|-0.025|
72362030|NCT02977403|144235718|SUPERIORITY|Change scores were computed (post-intervention - pre-intervention = delta) for oscillatory power. A linear mixed model was run with change scores as the dependent variable. Between-subject factors were condition, recent LOC-eating (0=absent, 1=present), and a condition by LOC-eating interaction term. Oscillatory power analyses were nested within subject. Models included a random intercept and were adjusted for stimuli pairing type, age, fat mass, height, and race and ethnicity.|beta coefficient|-0.013|||||TWO_SIDED|95.0|-0.095|0.069||Effect sizes and 95% CIs, rather than statistical significance, were used. Cohen's d was interpreted as minimal to no effect (\<.02) small effect (0.2-0.49) medium effect (0.5-0.79) large effect (0.8).|||To examine changes in oscillatory power, change scores were computed (post-pre=delta). Positive scores represent an increase from pre- to post- intervention. Negative scores represent a decrease from pre- to post- intervention.|Sample size estimation was based on the power analysis for the first hypothesis (examine changes in oscillatory power following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||0.069|-0.095|
72362031|NCT02977403|144235718|SUPERIORITY|See Statistical Analysis 1 for details. No p-values supplied, only confidence intervals and Cohen's d|beta coefficient|-0.078|||||TWO_SIDED|95.0|-0.227|0.071||||||Interaction of Loss of Control Eating with attention bias. See Statistical Analysis 1 for details.||0.071|-0.227|
72362032|NCT02977403|144235719|SUPERIORITY|Change scores were computed (post-intervention - pre-intervention = delta) for oscillatory power. A linear mixed model was run with change scores as the dependent variable. Between-subject factors were condition, recent LOC-eating (0=absent, 1=present), and a condition by LOC-eating interaction term. Oscillatory power analyses were nested within subject. Models included a random intercept and were adjusted for stimuli pairing type, age, fat mass, height, and race and ethnicity.|beta coefficient|-0.005|||||TWO_SIDED|95.0|-0.103|0.092||Effect sizes and 95% CIs, rather than statistical significance, were used. Cohen's d was interpreted as minimal to no effect (\<.02) small effect (0.2-0.49) medium effect (0.5-0.79) large effect (0.8).|||To examine changes in oscillatory power, change scores were computed (post-pre=delta). Positive scores represent an increase from pre- to post- intervention. Negative scores represent a decrease from pre- to post- intervention.|Sample size estimation was based on the power analysis for the first hypothesis (examine changes in oscillatory power following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||0.092|-0.103|
72362033|NCT02977403|144235719|SUPERIORITY|See Statistical Analysis 1 for details. No p-values supplied, only confidence intervals and Cohen's d|beta coefficient|-0.032|||||TWO_SIDED|95.0|-0.173|0.11||||||Interaction of Loss of Control Eating with attention bias. See Statistical Analysis 1 for details.||0.110|-0.173|
72362034|NCT02977403|144235720|SUPERIORITY|Change scores were computed (post-intervention - pre-intervention = delta) for oscillatory power. A linear mixed model was run with change scores as the dependent variable. Between-subject factors were condition, recent LOC-eating (0=absent, 1=present), and a condition by LOC-eating interaction term. Oscillatory power analyses were nested within subject. Models included a random intercept and were adjusted for stimuli pairing type, age, fat mass, height, and race and ethnicity.|beta coefficient|0.02|||||TWO_SIDED|95.0|-0.069|0.109||Effect sizes and 95% CIs, rather than statistical significance, were used. Cohen's d was interpreted as minimal to no effect (\<.02) small effect (0.2-0.49) medium effect (0.5-0.79) large effect (0.8).|||To examine changes in oscillatory power, change scores were computed (post-pre=delta). Positive scores represent an increase from pre- to post- intervention. Negative scores represent a decrease from pre- to post- intervention.|Sample size estimation was based on the power analysis for the first hypothesis (examine changes in oscillatory power following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||0.109|-0.069|
72362035|NCT02977403|144235720|SUPERIORITY|See Statistical Analysis 1 for details. No p-values supplied, only confidence intervals and Cohen's d|beta coefficient|-0.088|||||TWO_SIDED|95.0|-0.252|0.077||||||Interaction of Loss of Control Eating with attention bias. See Statistical Analysis 1 for details.||0.077|-0.252|
72362036|NCT02977403|144235721|OTHER|Change scores were computed (post-intervention - pre-intervention = delta) for oscillatory power. A linear mixed model was run with change scores as the dependent variable. Between-subject factors were condition, recent LOC-eating (0=absent, 1=present), and a condition by LOC-eating interaction term. Oscillatory power analyses were nested within subject. Models included a random intercept and were adjusted for stimuli pairing type, age, fat mass, height, and race and ethnicity.|beta coefficient|-0.01|||||TWO_SIDED|95.0|-0.099|0.08||Effect sizes and 95% CIs, rather than statistical significance, were used. Cohen's d was interpreted as minimal to no effect (\<.02) small effect (0.2-0.49) medium effect (0.5-0.79) large effect (0.8).|||To examine changes in oscillatory power, change scores were computed (post-pre=delta). Positive scores represent an increase from pre- to post- intervention. Negative scores represent a decrease from pre- to post- intervention.|Sample size estimation was based on the power analysis for the first hypothesis (examine changes in oscillatory power following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||0.080|-0.099|
72362037|NCT02977403|144235721|SUPERIORITY|See Statistical Analysis 1 for details. No p-values supplied, only confidence intervals and Cohen's d|beta coefficient|-0.155|||||TWO_SIDED|95.0|-0.294|-0.017||||||Interaction of Loss of Control Eating with attention bias. See Statistical Analysis 1 for details.||-0.017|-0.294|
72368437|NCT03682770|144247058|SUPERIORITY||Difference in percentage|20.23||||0.042|TWO_SIDED|95.0|1.266|39.189||The p-value was derived by Cochran-Mantel-Haenszel (CMH) test stratified by screening peanut-specific IgE level and baseline body weight.|Cochran-Mantel-Haenszel||Difference in percentage derived by Mantel-Haenszel (MH) method|||39.189|1.266|0.0420
72368438|NCT03682770|144247059|SUPERIORITY||Least Square Mean Difference|0.67||||0.04|TWO_SIDED|95.0|0.031|1.305||P-value is based on treatment difference (dupilumab + AR101 vs placebo + AR101) of the LS mean change using analysis of covariance (ANCOVA) model.|ANCOVA|||||1.305|0.031|0.0400
72368439|NCT03682770|144247060|SUPERIORITY||Difference in percentage|11.91||||0.0806|TWO_SIDED|95.0|-3.612|27.44||P-values were derived by CMH test stratified by screening peanut-specific IgE level (\<=100 kilo allergy unit per liter \[kUA/L\] vs \>100 kUA/L) and body weight (\<30 kg, \>=30 and \<60 kg, or \>=60 kg).|Cochran-Mantel-Haenszel||Difference in percentage derived by MH method|||27.440|-3.612|0.0806
72362038|NCT02977403|144235722|SUPERIORITY|Change scores were computed (post-intervention - pre-intervention = delta) for oscillatory power. A linear mixed model was run with change scores as the dependent variable. Between-subject factors were condition, recent LOC-eating (0=absent, 1=present), and a condition by LOC-eating interaction term. Oscillatory power analyses were nested within subject. Models included a random intercept and were adjusted for stimuli pairing type, age, fat mass, height, and race and ethnicity.|beta coefficient|0.013|||||TWO_SIDED|95.0|-0.069|0.095||Effect sizes and 95% CIs, rather than statistical significance, were used. Cohen's d was interpreted as minimal to no effect (\<.02) small effect (0.2-0.49) medium effect (0.5-0.79) large effect (0.8).|||To examine changes in oscillatory power, change scores were computed (post-pre=delta). Positive scores represent an increase from pre- to post- intervention. Negative scores represent a decrease from pre- to post- intervention.|Sample size estimation was based on the power analysis for the first hypothesis (examine changes in oscillatory power following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||0.095|-0.069|
72362039|NCT02977403|144235722|SUPERIORITY|See Statistical Analysis 1 for details. No p-values supplied, only confidence intervals and Cohen's d|beta coefficient|-0.085|||||TWO_SIDED|95.0|-0.216|0.047||||||Interaction of Loss of Control Eating with attention bias. See Statistical Analysis 1 for details.||0.047|-0.216|
72362040|NCT02977403|144235723|SUPERIORITY|Change scores were computed (post-intervention - pre-intervention = delta) for oscillatory power. A linear mixed model was run with change scores as the dependent variable. Between-subject factors were condition, recent LOC-eating (0=absent, 1=present), and a condition by LOC-eating interaction term. Oscillatory power analyses were nested within subject. Models included a random intercept and were adjusted for stimuli pairing type, age, fat mass, height, and race and ethnicity.|beta coefficient|-0.041|||||TWO_SIDED|95.0|-0.123|0.041||Effect sizes and 95% CIs, rather than statistical significance, were used. Cohen's d was interpreted as minimal to no effect (\<.02) small effect (0.2-0.49) medium effect (0.5-0.79) large effect (0.8).|||To examine changes in oscillatory power, change scores were computed (post-pre=delta). Positive scores represent an increase from pre- to post- intervention. Negative scores represent a decrease from pre- to post- intervention.|Sample size estimation was based on the power analysis for the first hypothesis (examine changes in oscillatory power following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||0.041|-0.123|
72362041|NCT02977403|144235723|SUPERIORITY|See Statistical Analysis 1 for details. No p-values supplied, only confidence intervals and Cohen's d|beta coefficient|-0.096|||||TWO_SIDED|95.0|-0.213|0.021||||||Interaction of Loss of Control Eating with attention bias. See Statistical Analysis 1 for details.||0.021|-0.213|
72362042|NCT02977403|144235724|SUPERIORITY|Change scores were computed (post-intervention - pre-intervention = delta) for oscillatory power. A linear mixed model was run with change scores as the dependent variable. Between-subject factors were condition, recent LOC-eating (0=absent, 1=present), and a condition by LOC-eating interaction term. Oscillatory power analyses were nested within subject. Models included a random intercept and were adjusted for stimuli pairing type, age, fat mass, height, and race and ethnicity.|beta coefficient|-0.038|||||TWO_SIDED|95.0|-0.142|0.066||Effect sizes and 95% CIs, rather than statistical significance, were used. Cohen's d was interpreted as minimal to no effect (\<.02) small effect (0.2-0.49) medium effect (0.5-0.79) large effect (0.8).|||To examine changes in oscillatory power, change scores were computed (post-pre=delta). Positive scores represent an increase from pre- to post- intervention. Negative scores represent a decrease from pre- to post- intervention.|Sample size estimation was based on the power analysis for the first hypothesis (examine changes in oscillatory power following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||0.066|-0.142|
72362043|NCT02977403|144235724|SUPERIORITY|See Statistical Analysis 1 for details. No p-values supplied, only confidence intervals and Cohen's d|beta coefficient|-0.096|||||TWO_SIDED|95.0|-0.29|0.097||||||Interaction of Loss of Control Eating with attention bias. See Statistical Analysis 1 for details.||0.097|-0.290|
72362044|NCT02977403|144235725|SUPERIORITY|Change scores were computed (post-intervention - pre-intervention = delta) for oscillatory power. A linear mixed model was run with change scores as the dependent variable. Between-subject factors were condition, recent LOC-eating (0=absent, 1=present), and a condition by LOC-eating interaction term. Oscillatory power analyses were nested within subject. Models included a random intercept and were adjusted for stimuli pairing type, age, fat mass, height, and race and ethnicity.|beta coefficient|-0.023|||||TWO_SIDED|95.0|-0.105|0.059||Effect sizes and 95% CIs, rather than statistical significance, were used. Cohen's d was interpreted as minimal to no effect (\<.02) small effect (0.2-0.49) medium effect (0.5-0.79) large effect (0.8).|||To examine changes in oscillatory power, change scores were computed (post-pre=delta). Positive scores represent an increase from pre- to post- intervention. Negative scores represent a decrease from pre- to post- intervention.|Sample size estimation was based on the power analysis for the first hypothesis (examine changes in oscillatory power following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||0.059|-0.105|
72362045|NCT02977403|144235725|SUPERIORITY|See Statistical Analysis 1 for details. No p-values supplied, only confidence intervals and Cohen's d|beta coefficient|-0.124|||||TWO_SIDED|95.0|-0.277|0.029||||||Interaction of Loss of Control Eating with attention bias. See Statistical Analysis 1 for details.||0.029|-0.277|
72368440|NCT03682770|144247062|SUPERIORITY||Difference in percentage|10.4||||0.353|TWO_SIDED|95.0|-11.668|32.474||P-values were derived by CMH test stratified by screening peanut-specific IgE level (\<=100 kUA/L vs \>100 kUA/L) and baseline body weight (\<30 kg, \>=30 kg and \<60 kg, or \>=60 kg).|Cochran-Mantel-Haenszel||Difference in percentage derived by MH method|||32.474|-11.668|0.3530
72368441|NCT03682770|144247063|SUPERIORITY||Least Square Mean Difference|0.37||||0.2628|TWO_SIDED|95.0|-0.281|1.029||P-value is based on treatment difference of the LS mean change using ANCOVA model with baseline tolerated cumulative amount of peanut protein DBPCFC (log transformed) as covariate and the treatment screening peanut-specific IgE level and baseline.|ANCOVA|||||1.029|-0.281|0.2628
72368442|NCT03682770|144247064|SUPERIORITY||Difference in percentage|-2.36||||0.814|TWO_SIDED|95.0|-25.004|20.282||P-values were derived by CMH test stratified by screening peanut-specific IgE level (\<=100 kUA/L vs \>100 kUA/L) and baseline body weight (\<30 kg, \>=30 kg and \<60 kg, or \>=60 kg).|Cochran-Mantel-Haenszel||Difference in percentage derived by MH method|||20.282|-25.004|0.8140
72362046|NCT02977403|144235726|SUPERIORITY|Change scores were computed (post-intervention - pre-intervention = delta) for oscillatory power. A linear mixed model was run with change scores as the dependent variable. Between-subject factors were condition, recent LOC-eating (0=absent, 1=present), and a condition by LOC-eating interaction term. Oscillatory power analyses were nested within subject. Models included a random intercept and were adjusted for stimuli pairing type, age, fat mass, height, and race and ethnicity.|beta coefficient|-0.057|||||TWO_SIDED|95.0|-0.14|0.027||Effect sizes and 95% CIs, rather than statistical significance, were used. Cohen's d was interpreted as minimal to no effect (\<.02) small effect (0.2-0.49) medium effect (0.5-0.79) large effect (0.8).|||To examine changes in oscillatory power, change scores were computed (post-pre=delta). Positive scores represent an increase from pre- to post- intervention. Negative scores represent a decrease from pre- to post- intervention.|Sample size estimation was based on the power analysis for the first hypothesis (examine changes in oscillatory power following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||0.027|-0.140|
72362047|NCT02977403|144235726|SUPERIORITY|See Statistical Analysis 1 for details. No p-values supplied, only confidence intervals and Cohen's d|beta coefficient|-0.161|||||TWO_SIDED|95.0|-0.302|-0.02||||||Interaction of Loss of Control Eating with attention bias. See Statistical Analysis 1 for details.||-0.020|-0.302|
72362048|NCT02977403|144235727|SUPERIORITY|Change scores were computed (post-intervention - pre-intervention = delta) for oscillatory power. A linear mixed model was run with change scores as the dependent variable. Between-subject factors were condition, recent LOC-eating (0=absent, 1=present), and a condition by LOC-eating interaction term. Oscillatory power analyses were nested within subject. Models included a random intercept and were adjusted for stimuli pairing type, age, fat mass, height, and race and ethnicity.|beta coefficient|-0.0002|||||TWO_SIDED|95.0|-0.091|0.091||Effect sizes and 95% CIs, rather than statistical significance, were used. Cohen's d was interpreted as minimal to no effect (\<.02) small effect (0.2-0.49) medium effect (0.5-0.79) large effect (0.8).|||To examine changes in oscillatory power, change scores were computed (post-pre=delta). Positive scores represent an increase from pre- to post- intervention. Negative scores represent a decrease from pre- to post- intervention.|Sample size estimation was based on the power analysis for the first hypothesis (examine changes in oscillatory power following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||0.091|-0.091|
72362049|NCT02977403|144235727|SUPERIORITY|See Statistical Analysis 1 for details. No p-values supplied, only confidence intervals and Cohen's d|beta coefficient|-0.004|||||TWO_SIDED|95.0|-0.157|0.149||||||Interaction of Loss of Control Eating with attention bias. See Statistical Analysis 1 for details.||0.149|-0.157|
72362050|NCT02977403|144235728|SUPERIORITY|Change scores were computed (post-intervention - pre-intervention = delta) for oscillatory power. A linear mixed model was run with change scores as the dependent variable. Between-subject factors were condition, recent LOC-eating (0=absent, 1=present), and a condition by LOC-eating interaction term. Oscillatory power analyses were nested within subject. Models included a random intercept and were adjusted for stimuli pairing type, age, fat mass, height, and race and ethnicity.|beta coefficient|-0.01|||||TWO_SIDED|95.0|-0.092|0.071||Effect sizes and 95% CIs, rather than statistical significance, were used. Cohen's d was interpreted as minimal to no effect (\<.02) small effect (0.2-0.49) medium effect (0.5-0.79) large effect (0.8).|||To examine changes in oscillatory power, change scores were computed (post-pre=delta). Positive scores represent an increase from pre- to post- intervention. Negative scores represent a decrease from pre- to post- intervention.|Sample size estimation was based on the power analysis for the first hypothesis (examine changes in oscillatory power following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||0.071|-0.092|
72362051|NCT02977403|144235728|SUPERIORITY|See Statistical Analysis 1 for details. No p-values supplied, only confidence intervals and Cohen's d|beta coefficient|0.029|||||TWO_SIDED|95.0|-0.126|0.183||||||Interaction of Loss of Control Eating with attention bias. See Statistical Analysis 1 for details.||0.183|-0.126|
72362052|NCT02977403|144235729|SUPERIORITY|Change scores were computed (post-intervention - pre-intervention = delta) for oscillatory power. A linear mixed model was run with change scores as the dependent variable. Between-subject factors were condition, recent LOC-eating (0=absent, 1=present), and a condition by LOC-eating interaction term. Oscillatory power analyses were nested within subject. Models included a random intercept and were adjusted for stimuli pairing type, age, fat mass, height, and race and ethnicity.|beta coefficient|-0.013|||||TWO_SIDED|95.0|-0.101|0.076||Effect sizes and 95% CIs, rather than statistical significance, were used. Cohen's d was interpreted as minimal to no effect (\<.02) small effect (0.2-0.49) medium effect (0.5-0.79) large effect (0.8).|||To examine changes in oscillatory power, change scores were computed (post-pre=delta). Positive scores represent an increase from pre- to post- intervention. Negative scores represent a decrease from pre- to post- intervention.|Sample size estimation was based on the power analysis for the first hypothesis (examine changes in oscillatory power following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||0.076|-0.101|
72362053|NCT02977403|144235729|SUPERIORITY|See Statistical Analysis 1 for details. No p-values supplied, only confidence intervals and Cohen's d|beta coefficient|-0.106|||||TWO_SIDED|95.0|-0.273|0.06||||||Interaction of Loss of Control Eating with attention bias. See Statistical Analysis 1 for details.||0.060|-0.273|
72368443|NCT03682770|144247065|SUPERIORITY||Least Square Mean Difference|-0.05||||0.8805|TWO_SIDED|95.0|-0.699|0.599||P-value is based on treatment difference of the LS mean change using ANCOVA model with baseline tolerated cumulative amount of peanut protein DBPCFC (log transformed) as covariate and the treatment screening peanut-specific IgE level and baseline.|ANCOVA|||||0.599|-0.699|0.8805
72362054|NCT02977403|144235730|SUPERIORITY|Change scores were computed (post-intervention - pre-intervention = delta) for oscillatory power. A linear mixed model was run with change scores as the dependent variable. Between-subject factors were condition, recent LOC-eating (0=absent, 1=present), and a condition by LOC-eating interaction term. Oscillatory power analyses were nested within subject. Models included a random intercept and were adjusted for stimuli pairing type, age, fat mass, height, and race and ethnicity.|beta coefficient|-0.033|||||TWO_SIDED|95.0|-0.11|0.043||Effect sizes and 95% CIs, rather than statistical significance, were used. Cohen's d was interpreted as minimal to no effect (\<.02) small effect (0.2-0.49) medium effect (0.5-0.79) large effect (0.8).|||To examine changes in oscillatory power, change scores were computed (post-pre=delta). Positive scores represent an increase from pre- to post- intervention. Negative scores represent a decrease from pre- to post- intervention.|Sample size estimation was based on the power analysis for the first hypothesis (examine changes in oscillatory power following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||0.043|-0.110|
72362055|NCT02977403|144235730|SUPERIORITY|See Statistical Analysis 1 for details. No p-values supplied, only confidence intervals and Cohen's d|beta coefficient|-0.166|||||TWO_SIDED|95.0|-0.335|0.003||||||Interaction of Loss of Control Eating with attention bias. See Statistical Analysis 1 for details.||0.003|-0.335|
72362056|NCT02977403|144235731|SUPERIORITY|Change scores were computed (post-intervention - pre-intervention = delta) for oscillatory power. A linear mixed model was run with change scores as the dependent variable. Between-subject factors were condition, recent LOC-eating (0=absent, 1=present), and a condition by LOC-eating interaction term. Oscillatory power analyses were nested within subject. Models included a random intercept and were adjusted for stimuli pairing type, age, fat mass, height, and race and ethnicity.|beta coefficient|0.011|||||TWO_SIDED|95.0|-0.069|0.091||Effect sizes and 95% CIs, rather than statistical significance, were used. Cohen's d was interpreted as minimal to no effect (\<.02) small effect (0.2-0.49) medium effect (0.5-0.79) large effect (0.8).|||To examine changes in oscillatory power, change scores were computed (post-pre=delta). Positive scores represent an increase from pre- to post- intervention. Negative scores represent a decrease from pre- to post- intervention.|Sample size estimation was based on the power analysis for the first hypothesis (examine changes in oscillatory power following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||0.091|-0.069|
72362057|NCT02977403|144235731|SUPERIORITY|See Statistical Analysis 1 for details. No p-values supplied, only confidence intervals and Cohen's d|beta coefficient|-0.167|||||TWO_SIDED|95.0|-0.332|-0.002||||||Interaction of Loss of Control Eating with attention bias. See Statistical Analysis 1 for details.||-0.002|-0.332|
72362058|NCT02977403|144235732|SUPERIORITY|Change scores were computed (post-intervention - pre-intervention = delta) for oscillatory power. A linear mixed model was run with change scores as the dependent variable. Between-subject factors were condition, recent LOC-eating (0=absent, 1=present), and a condition by LOC-eating interaction term. Oscillatory power analyses were nested within subject. Models included a random intercept and were adjusted for stimuli pairing type, age, fat mass, height, and race and ethnicity.|beta coefficient|0.054|||||TWO_SIDED|95.0|-0.037|0.146||Effect sizes and 95% CIs, rather than statistical significance, were used. Cohen's d was interpreted as minimal to no effect (\<.02) small effect (0.2-0.49) medium effect (0.5-0.79) large effect (0.8).|||To examine changes in oscillatory power, change scores were computed (post-pre=delta). Positive scores represent an increase from pre- to post- intervention. Negative scores represent a decrease from pre- to post- intervention.|Sample size estimation was based on the power analysis for the first hypothesis (examine changes in oscillatory power following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||0.146|-0.037|
72362059|NCT02977403|144235732|SUPERIORITY|See Statistical Analysis 1 for details. No p-values supplied, only confidence intervals and Cohen's d|beta coefficient|-0.019|||||TWO_SIDED|95.0|-0.127|0.09||||||Interaction of Loss of Control Eating with attention bias. See Statistical Analysis 1 for details.||0.090|-0.127|
72362060|NCT02977403|144235733|SUPERIORITY|Change scores were computed (post-intervention - pre-intervention = delta) for oscillatory power. A linear mixed model was run with change scores as the dependent variable. Between-subject factors were condition, recent LOC-eating (0=absent, 1=present), and a condition by LOC-eating interaction term. Oscillatory power analyses were nested within subject. Models included a random intercept and were adjusted for stimuli pairing type, age, fat mass, height, and race and ethnicity.|beta coefficient|0.002|||||TWO_SIDED|95.0|-0.061|0.065||Effect sizes and 95% CIs, rather than statistical significance, were used. Cohen's d was interpreted as minimal to no effect (\<.02) small effect (0.2-0.49) medium effect (0.5-0.79) large effect (0.8).|||To examine changes in oscillatory power, change scores were computed (post-pre=delta). Positive scores represent an increase from pre- to post- intervention. Negative scores represent a decrease from pre- to post- intervention.|Sample size estimation was based on the power analysis for the first hypothesis (examine changes in oscillatory power following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||0.065|-0.061|
72362061|NCT02977403|144235733|SUPERIORITY|See Statistical Analysis 1 for details. No p-values supplied, only confidence intervals and Cohen's d|beta coefficient|-0.086|||||TWO_SIDED|95.0|-0.215|0.042||||||Interaction of Loss of Control Eating with attention bias. See Statistical Analysis 1 for details.||0.042|-0.215|
72368444|NCT03682770|144247067|SUPERIORITY||Difference percentage|-85.55|||<|0.0001|TWO_SIDED|95.0|-99.47|-73.91||P-value was based on treatment difference (vs. Continuously on Placebo + AR101) in percent change from baseline using rank-based ANCOVA model with baseline measurement as covariate,- and stratification factors and the treatment as fixed factors.|ANCOVA||Median difference and its 95% CIs were estimated with the Hodges-Lehmann method.|||-73.91|-99.47|<0.0001
72368445|NCT03682770|144247068|SUPERIORITY||Difference in percentage|-68.78|||<|0.0001|TWO_SIDED|95.0|-86.71|-56.4||P-value was based on treatment difference (vs. Continuously on Placebo + AR101) in percent change from baseline using rank-based ANCOVA model with baseline measurement as covariate, and stratification factors and the treatment as fixed factors.|ANCOVA||Median difference and its 95% CIs were estimated with the Hodges-Lehmann method.|||-56.40|-86.71|<0.0001
72368446|NCT02362282|144247069|SUPERIORITY|||||||0.54|||||||t-test, 2 sided|||||||0.54
72368447|NCT01166282|144247078|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-51.17|||=|0.039|TWO_SIDED|95.0|-99.69|-2.66|||ANCOVA|||||-2.66|-99.69|=0.039
72362062|NCT02977403|144235734|SUPERIORITY|Change scores were computed (post-intervention - pre-intervention = delta) for oscillatory power. A linear mixed model was run with change scores as the dependent variable. Between-subject factors were condition, recent LOC-eating (0=absent, 1=present), and a condition by LOC-eating interaction term. Oscillatory power analyses were nested within subject. Models included a random intercept and were adjusted for stimuli pairing type, age, fat mass, height, and race and ethnicity.|beta coefficient|0.032|||||TWO_SIDED|95.0|-0.05|0.115||Effect sizes and 95% CIs, rather than statistical significance, were used. Cohen's d was interpreted as minimal to no effect (\<.02) small effect (0.2-0.49) medium effect (0.5-0.79) large effect (0.8).|||To examine changes in oscillatory power, change scores were computed (post-pre=delta). Positive scores represent an increase from pre- to post- intervention. Negative scores represent a decrease from pre- to post- intervention.|Sample size estimation was based on the power analysis for the first hypothesis (examine changes in oscillatory power following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||0.115|-0.05|
72362063|NCT02977403|144235734|SUPERIORITY|See Statistical Analysis 1 for details. No p-values supplied, only confidence intervals and Cohen's d|beta coefficient|-0.095|||||TWO_SIDED|95.0|-0.248|0.058||||||Interaction of Loss of Control Eating with attention bias. See Statistical Analysis 1 for details.||0.058|-0.248|
72362064|NCT02977403|144235735|SUPERIORITY|Change scores were computed (post-intervention - pre-intervention = delta) for oscillatory power. A linear mixed model was run with change scores as the dependent variable. Between-subject factors were condition, recent LOC-eating (0=absent, 1=present), and a condition by LOC-eating interaction term. Oscillatory power analyses were nested within subject. Models included a random intercept and were adjusted for stimuli pairing type, age, fat mass, height, and race and ethnicity.|beta coefficient|-0.016|||||TWO_SIDED|95.0|-0.075|0.042||Effect sizes and 95% CIs, rather than statistical significance, were used. Cohen's d was interpreted as minimal to no effect (\<.02) small effect (0.2-0.49) medium effect (0.5-0.79) large effect (0.8).|||To examine changes in oscillatory power, change scores were computed (post-pre=delta). Positive scores represent an increase from pre- to post- intervention. Negative scores represent a decrease from pre- to post- intervention.|Sample size estimation was based on the power analysis for the first hypothesis (examine changes in oscillatory power following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||0.042|-0.075|
72362065|NCT02977403|144235735|SUPERIORITY|See Statistical Analysis 1 for details. No p-values supplied, only confidence intervals and Cohen's d|beta coefficient|0.025|||||TWO_SIDED|95.0|-0.13|0.18||||||Interaction of Loss of Control Eating with attention bias. See Statistical Analysis 1 for details.||0.180|-0.130|
72362066|NCT02977403|144235736|SUPERIORITY|Change scores were computed (post-intervention - pre-intervention = delta) for oscillatory power. A linear mixed model was run with change scores as the dependent variable. Between-subject factors were condition, recent LOC-eating (0=absent, 1=present), and a condition by LOC-eating interaction term. Oscillatory power analyses were nested within subject. Models included a random intercept and were adjusted for stimuli pairing type, age, fat mass, height, and race and ethnicity.|beta coefficient|0.03|||||TWO_SIDED|95.0|-0.039|0.099||Effect sizes and 95% CIs, rather than statistical significance, were used. Cohen's d was interpreted as minimal to no effect (\<.02) small effect (0.2-0.49) medium effect (0.5-0.79) large effect (0.8).||||Sample size estimation was based on the power analysis for the first hypothesis (examine changes in oscillatory power following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||0.099|-0.039|
72362067|NCT02977403|144235736|SUPERIORITY|See Statistical Analysis 1 for details. No p-values supplied, only confidence intervals and Cohen's d|beta coefficient|-0.143|||||TWO_SIDED|95.0|-0.335|0.049||||||Interaction of Loss of Control Eating with attention bias. See Statistical Analysis 1 for details.||0.049|-0.335|
72362068|NCT02977403|144235737|SUPERIORITY|Change scores were computed (post-intervention - pre-intervention = delta) for oscillatory power. A linear mixed model was run with change scores as the dependent variable. Between-subject factors were condition, recent LOC-eating (0=absent, 1=present), and a condition by LOC-eating interaction term. Oscillatory power analyses were nested within subject. Models included a random intercept and were adjusted for stimuli pairing type, age, fat mass, height, and race and ethnicity.|beta coefficient|-0.016|||||TWO_SIDED|95.0|-0.097|0.066||Effect sizes and 95% CIs, rather than statistical significance, were used. Cohen's d was interpreted as minimal to no effect (\<.02) small effect (0.2-0.49) medium effect (0.5-0.79) large effect (0.8).|||To examine changes in oscillatory power, change scores were computed (post-pre=delta). Positive scores represent an increase from pre- to post- intervention. Negative scores represent a decrease from pre- to post- intervention.|Sample size estimation was based on the power analysis for the first hypothesis (examine changes in oscillatory power following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||0.066|-0.097|
72362069|NCT02977403|144235737|SUPERIORITY|See Statistical Analysis 1 for details. No p-values supplied, only confidence intervals and Cohen's d|beta coefficient|-0.162|||||TWO_SIDED|95.0|-0.314|-0.01||||||Interaction of Loss of Control Eating with attention bias. See Statistical Analysis 1 for details.||-0.01|-0.314|
72362070|NCT02977403|144235738|SUPERIORITY|Change scores were computed (post-intervention - pre-intervention = delta) for oscillatory power. A linear mixed model was run with change scores as the dependent variable. Between-subject factors were condition, recent LOC-eating (0=absent, 1=present), and a condition by LOC-eating interaction term. Oscillatory power analyses were nested within subject. Models included a random intercept and were adjusted for stimuli pairing type, age, fat mass, height, and race and ethnicity.|beta coefficient|0.053|||||TWO_SIDED|95.0|-0.051|0.156||Effect sizes and 95% CIs, rather than statistical significance, were used. Cohen's d was interpreted as minimal to no effect (\<.02) small effect (0.2-0.49) medium effect (0.5-0.79) large effect (0.8).|||To examine changes in oscillatory power, change scores were computed (post-pre=delta). Positive scores represent an increase from pre- to post- intervention. Negative scores represent a decrease from pre- to post- intervention.|Sample size estimation was based on the power analysis for the first hypothesis (examine changes in oscillatory power following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||0.156|-0.051|
72362071|NCT02977403|144235738|SUPERIORITY|See Statistical Analysis 1 for details. No p-values supplied, only confidence intervals and Cohen's d|beta coefficient|-0.07|||||TWO_SIDED|95.0|-0.251|0.111||||||Interaction of Loss of Control Eating with attention bias. See Statistical Analysis 1 for details.||0.111|-0.251|
72362072|NCT02977403|144235739|SUPERIORITY|Change scores were computed (post-intervention - pre-intervention = delta) for oscillatory power. A linear mixed model was run with change scores as the dependent variable. Between-subject factors were condition, recent LOC-eating (0=absent, 1=present), and a condition by LOC-eating interaction term. Oscillatory power analyses were nested within subject. Models included a random intercept and were adjusted for stimuli pairing type, age, fat mass, height, and race and ethnicity.|beta coefficient|0.015|||||TWO_SIDED|95.0|-0.061|0.091||Effect sizes and 95% CIs, rather than statistical significance, were used. Cohen's d was interpreted as minimal to no effect (\<.02) small effect (0.2-0.49) medium effect (0.5-0.79) large effect (0.8).|||To examine changes in oscillatory power, change scores were computed (post-pre=delta). Positive scores represent an increase from pre- to post- intervention. Negative scores represent a decrease from pre- to post- intervention.|Sample size estimation was based on the power analysis for the first hypothesis (examine changes in oscillatory power following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||0.091|-0.061|
72362073|NCT02977403|144235739|SUPERIORITY|See Statistical Analysis 1 for details. No p-values supplied, only confidence intervals and Cohen's d|beta coefficient|-0.108|||||TWO_SIDED|95.0|-0.26|0.044||||||Interaction of Loss of Control Eating with attention bias. See Statistical Analysis 1 for details.||0.044|-0.260|
72362074|NCT02977403|144235740|SUPERIORITY|Change scores were computed (post-intervention - pre-intervention = delta) for oscillatory power. A linear mixed model was run with change scores as the dependent variable. Between-subject factors were condition, recent LOC-eating (0=absent, 1=present), and a condition by LOC-eating interaction term. Oscillatory power analyses were nested within subject. Models included a random intercept and were adjusted for stimuli pairing type, age, fat mass, height, and race and ethnicity.|beta coefficient|0.036|||||TWO_SIDED|95.0|-0.047|0.119||Effect sizes and 95% CIs, rather than statistical significance, were used. Cohen's d was interpreted as minimal to no effect (\<.02) small effect (0.2-0.49) medium effect (0.5-0.79) large effect (0.8).|||To examine changes in oscillatory power, change scores were computed (post-pre=delta). Positive scores represent an increase from pre- to post- intervention. Negative scores represent a decrease from pre- to post- intervention.|Sample size estimation was based on the power analysis for the first hypothesis (examine changes in oscillatory power following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||0.119|-0.047|
72362075|NCT02977403|144235740|SUPERIORITY|See Statistical Analysis 1 for details. No p-values supplied, only confidence intervals and Cohen's d|beta coefficient|-0.106|||||TWO_SIDED|95.0|-0.276|0.064||||||Interaction of Loss of Control Eating with attention bias. See Statistical Analysis 1 for details.||0.064|-0.276|
72362076|NCT02977403|144235741|SUPERIORITY|Change scores were computed (post-intervention - pre-intervention = delta) for oscillatory power. A linear mixed model was run with change scores as the dependent variable. Between-subject factors were condition, recent LOC-eating (0=absent, 1=present), and a condition by LOC-eating interaction term. Oscillatory power analyses were nested within subject. Models included a random intercept and were adjusted for stimuli pairing type, age, fat mass, height, and race and ethnicity.|beta coefficient|-0.017|||||TWO_SIDED|95.0|-0.092|0.057||Effect sizes and 95% CIs, rather than statistical significance, were used. Cohen's d was interpreted as minimal to no effect (\<.02) small effect (0.2-0.49) medium effect (0.5-0.79) large effect (0.8).|||To examine changes in oscillatory power, change scores were computed (post-pre=delta). Positive scores represent an increase from pre- to post- intervention. Negative scores represent a decrease from pre- to post- intervention.|Sample size estimation was based on the power analysis for the first hypothesis (examine changes in oscillatory power following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||0.057|-0.092|
72362077|NCT02977403|144235741|SUPERIORITY|See Statistical Analysis 1 for details. No p-values supplied, only confidence intervals and Cohen's d|beta coefficient|0.002|||||TWO_SIDED|95.0|-0.15|0.153||||||Interaction of Loss of Control Eating with attention bias. See Statistical Analysis 1 for details.||0.153|-0.150|
72362078|NCT02977403|144235742|SUPERIORITY|Change scores were computed (post-intervention - pre-intervention = delta) for oscillatory power. A linear mixed model was run with change scores as the dependent variable. Between-subject factors were condition, recent LOC-eating (0=absent, 1=present), and a condition by LOC-eating interaction term. Oscillatory power analyses were nested within subject. Models included a random intercept and were adjusted for stimuli pairing type, age, fat mass, height, and race and ethnicity.|beta coefficient|0.07|||||TWO_SIDED|95.0|-0.019|0.159||Effect sizes and 95% CIs, rather than statistical significance, were used. Cohen's d was interpreted as minimal to no effect (\<.02) small effect (0.2-0.49) medium effect (0.5-0.79) large effect (0.8).|||To examine changes in oscillatory power, change scores were computed (post-pre=delta). Positive scores represent an increase from pre- to post- intervention. Negative scores represent a decrease from pre- to post- intervention.|Sample size estimation was based on the power analysis for the first hypothesis (examine changes in oscillatory power following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||0.159|-0.019|
72362079|NCT02977403|144235742|SUPERIORITY|See Statistical Analysis 1 for details. No p-values supplied, only confidence intervals and Cohen's d|beta coefficient|-0.095|||||TWO_SIDED|95.0|-0.26|0.07||||||Interaction of Loss of Control Eating with attention bias. See Statistical Analysis 1 for details.||0.070|-0.260|
72362080|NCT02977403|144235743|SUPERIORITY||beta coefficient|-0.8707|STANDARD_ERROR_OF_MEAN|0.766||0.256|TWO_SIDED||||||Generalized estimation equations||Reported variable is a condition by time (pre or post-intervention) interaction term. The model included a Poisson distribution, log link function, exchangeable covariance matrix and was adjusted for age, fat mass, height, and race and ethnicity.|Sample size estimation was based on the power analysis for the first hypothesis (examine changes in oscillatory power following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||||0.256
72362081|NCT02994108|144235758|SUPERIORITY||Chi-Square|0.415||||0.601|TWO_SIDED||||||Chi-squared|||||||.601
72362082|NCT02994108|144235759|SUPERIORITY||Mean Difference (Final Values)|-0.09||||0.249|TWO_SIDED||||||t-test, 2 sided|||||||.249
72362083|NCT02994108|144235760|SUPERIORITY||Mean Difference (Final Values)|-0.04||||0.675|TWO_SIDED||||||t-test, 2 sided|||||||.675
72362084|NCT02994108|144235761|SUPERIORITY||Odds Ratio (OR)|3.43||||0.025|TWO_SIDED|95.0|1.17|10.08|||Regression, Logistic|||||10.08|1.17|.025
72362085|NCT02994108|144235762|SUPERIORITY||Odds Ratio (OR)|1.14||||0.923|TWO_SIDED|95.0|0.08|16.95|||Regression, Logistic|||||16.95|0.08|.923
72362086|NCT02994108|144235763|SUPERIORITY||Mean Difference (Final Values)|-0.11||||0.174|TWO_SIDED||||||t-test, 2 sided|||||||.174
72362087|NCT02994108|144235764|SUPERIORITY||Mean Difference (Final Values)|-0.4||||0.002|TWO_SIDED||||||t-test, 2 sided|||||||.002
72362088|NCT02994108|144235765|SUPERIORITY||Mean Difference (Final Values)|0.01||||0.964|TWO_SIDED||||||t-test, 2 sided|||||||.964
72362089|NCT02994108|144235766|SUPERIORITY||Mean Difference (Final Values)|-0.34||||0.053|TWO_SIDED||||||t-test, 2 sided|||||||.053
72362090|NCT02994108|144235767|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.183|TWO_SIDED||||||t-test, 2 sided|||||||.183
72362091|NCT02994108|144235768|SUPERIORITY||Mean Difference (Final Values)|-0.26||||0.064|TWO_SIDED||||||t-test, 2 sided|||||||.064
72362092|NCT02994108|144235769|SUPERIORITY||Mean Difference (Final Values)|-0.22||||0.147|TWO_SIDED||||||t-test, 2 sided|||||||.147
72362093|NCT02994108|144235770|SUPERIORITY||Mean Difference (Final Values)|-0.29||||0.096|TWO_SIDED||||||t-test, 2 sided|||||||.096
72362094|NCT02994108|144235771|SUPERIORITY||Mean Difference (Final Values)|-0.41||||0.013|TWO_SIDED||||||t-test, 2 sided|||||||.013
72362095|NCT01097668|144235794|SUPERIORITY_OR_OTHER||||||<|0.001|||||||negative binomial model|||Comparison of the baseline 'ITT population' MRI data with week 16 data.||||<0.001
72362096|NCT01097668|144235794|SUPERIORITY_OR_OTHER|||||||0.03|||||||negative binomial model|||Comparison of the baseline 'MRI population' data with data from week 16.||||0.030
72362097|NCT02443688|144235796|OTHER|Single Group Difference from Placebo Mean Change from Baseline with 95% confidence interval (CI)|Mean Difference (Final Values)|1.39|STANDARD_ERROR_OF_MEAN|1.38|||TWO_SIDED|95.0|-1.34|4.12|||ANOVA|||||4.12|-1.34|
72362098|NCT02443688|144235796|OTHER|Single Group Difference from Placebo Mean Change from Baseline with 95% CI|Mean Difference (Final Values)|-1.07|STANDARD_ERROR_OF_MEAN|1.37|||TWO_SIDED|95.0|-3.78|1.64|||ANOVA|||||1.64|-3.78|
72362099|NCT02443688|144235796|SUPERIORITY|Difference from placebo of pooled arms (100mg CTX-4430 and 50mg CTX-4430) in change from baseline in ppFEV1 at Week 48.|Mean Difference (Final Values)|0.16|STANDARD_ERROR_OF_MEAN|1.2||0.45|TWO_SIDED|95.0|-2.2|2.5||0.1 alpha level (2-sided) prespecified|ANOVA|||||2.50|-2.20|0.45
72362100|NCT02443688|144235797|OTHER|Single Group Rate with 95% CI|see Estimation Comment below|1.57|STANDARD_ERROR_OF_MEAN|0.2|||TWO_SIDED|95.0|1.22|2.02|||||Estimated using negative binomial distribution by treatment group unadjusted for multiple comparisons.|||2.02|1.22|
72362101|NCT02443688|144235797|OTHER|Single Group Rate with 95% CI|see Estimation Comment below|1.46|STANDARD_ERROR_OF_MEAN|0.19|||TWO_SIDED|95.0|1.13|1.89|||||Estimated using negative binomial distribution by treatment group unadjusted for multiple comparisons.|||1.89|1.13|
72362102|NCT02443688|144235797|OTHER|Single Group Rate with 95% CI|see Estimation Comment below|1.56|STANDARD_ERROR_OF_MEAN|0.2|||TWO_SIDED|95.0|1.21|2.01|||||Estimated using negative binomial distribution by treatment group unadjusted for multiple comparisons.|||2.01|1.21|
72362103|NCT02443688|144235797|OTHER|Pooled Group Rate with 95% CI|see Estimation Comment below|1.51|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|1.26|1.81|||||Estimated using negative binomial distribution unadjusted for multiple comparisons.|||1.81|1.26|
72362104|NCT02443688|144235798|OTHER|95% 2-sided confidence interval for the Hazard Ratio relative to Placebo unadjusted for multiple comparisons|Hazard Ratio (HR)|0.88|STANDARD_ERROR_OF_MEAN|0.19|||TWO_SIDED|95.0|0.58|1.34|||Regression, Cox|||||1.34|0.58|
72362105|NCT02443688|144235798|OTHER|95% 2-sided confidence interval for the Hazard Ratio relative to Placebo unadjusted for multiple comparisons|Hazard Ratio (HR)|0.86|STANDARD_ERROR_OF_MEAN|0.18|||TWO_SIDED|95.0|0.56|1.31|||Regression, Cox|||||1.31|0.56|
72362106|NCT02443688|144235798|OTHER|95% 2-sided confidence interval for the Hazard Ratio Relative to Placebo unadjusted for multiple comparisons|Hazard Ratio (HR)|0.87|STANDARD_ERROR_OF_MEAN|0.16|||TWO_SIDED|95.0|0.61|1.25|||Regression, Cox|||||1.25|0.61|
72362107|NCT02443688|144235804|OTHER|Single Group Rate with 95% CI|see Estimation Comment below|0.84|STANDARD_ERROR_OF_MEAN|0.23|||TWO_SIDED|95.0|0.49|1.44|||||Estimated using negative binomial distribution by treatment group unadjusted for multiple comparisons.|||1.44|0.49|
72362108|NCT02443688|144235804|OTHER|Single Group Rate with 95% CI|see Estimation Comment below|1.28|STANDARD_ERROR_OF_MEAN|0.28|||TWO_SIDED|95.0|0.84|1.96|||||Estimated using negative binomial distribution by treatment group unadjusted for multiple comparisons.|||1.96|0.84|
72362109|NCT02443688|144235804|OTHER|Single Group Rate with 95% CI|see Estimation Comment below|1.61|STANDARD_ERROR_OF_MEAN|0.34|||TWO_SIDED|95.0|1.07|2.42|||||Estimated using negative binomial distribution by treatment group unadjusted for multiple comparisons.|||2.42|1.07|
72362110|NCT02443688|144235804|OTHER|Group Rate with 95% CI|see Estimation Comment below|1.04|STANDARD_ERROR_OF_MEAN|0.18|||TWO_SIDED|95.0|0.74|1.46|||||Estimated using negative binomial distribution by treatment group unadjusted for multiple comparisons.|||1.46|0.74|
72362111|NCT02443688|144235805|OTHER|95% 2-sided confidence interval for the Hazard Ratio Relative to Placebo unadjusted for multiple comparisons|Hazard Ratio (HR)|0.52|STANDARD_ERROR_OF_MEAN|0.2|||TWO_SIDED|95.0|0.25|1.1|||Regression, Cox|||||1.10|0.25|
72362112|NCT02443688|144235805|OTHER|95% 2-sided confidence interval for the Hazard Ratio Relative to Placebo unadjusted for multiple comparisons|Hazard Ratio (HR)|0.62|STANDARD_ERROR_OF_MEAN|0.18|||TWO_SIDED|95.0|0.3|1.27|||Regression, Cox|||||1.27|0.30|
72362113|NCT02443688|144235805|OTHER|95% 2-sided confidence interval for the Hazard Ratio Relative to Placebo unadjusted for multiple comparisons|Hazard Ratio (HR)|0.57|STANDARD_ERROR_OF_MEAN|0.18|||TWO_SIDED|95.0|0.31|1.05|||Regression, Cox|||||1.05|0.31|
72362114|NCT01231984|144235818|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Two one-sided 95% confidence limits for the difference in HbA1c between the 4mm PN and the 8mm PN was calculated. Equivalence limits for HbA1C were defined a-priori as +/- 0.4% units.|Effect of 4mm versus 8mm PN on HbA1c|-0.076|||||TWO_SIDED|95.0|-0.209|0.058|||Two one-sided 95% confidence limits|For equivalence testing, a 95% test is the same as two one-sided 95% confidence limits.||General linear models with baseline as a covariate, needle type, period, and randomization sequence as fixed effects, and subject as random effect were fit to the data.||0.058|-0.209|
72368448|NCT01166282|144247079|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.62|||=|0.382|TWO_SIDED|95.0|-5.32|2.08|||1-way ANOVA|||||2.08|-5.32|=0.382
72362115|NCT01231984|144235819|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Two one-sided 95% confidence limits for the difference in HbA1c between the 4 mm PN and the longer PNs (pooled) was calculated. Equivalence limits for HbA1c were defined a-priori as +/- 0.4% units.|Effect of 4mm PN vs. longer PN on HbA1c|-0.09|||||TWO_SIDED|95.0|-0.23|0.051|||Two one-sided 95% confidence limits|For equivalence testing, a 95% test is the same as two one-sided 95% confidence limits.||General linear models with baseline as a covariate, needle type, period, and randomization sequence as fixed effects, and subject as random effect were fit to the data.||0.051|-0.23|
72362116|NCT01231984|144235820|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|12.36|||<|0.05|ONE_SIDED|95.0|0.37|||p\< 0.05 was considered statistically significant in this study|t-test, 1 sided|||"Subjects rated the level of pain experienced when using the PN assigned for use during Study Period 2 compared to the PN assigned for use in Study Period 1. By placing a mark on a line, whose midpoint(anchor) was designated as 0, and represented equivalent pain with assigned PNs, ratings on the continuum represented the degree to which the PN used in the second Study Period was less than or greater than the PN used during the first Study Period."|||0.37|<0.05
72362117|NCT01231984|144235821|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|30.83|||<|0.05|ONE_SIDED|95.0|18.54|||p\< 0.05 was considered statistically significant in this study.|t-test, 1 sided||||||18.54|<0.05
72362118|NCT01231984|144235823|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Two one-sided 95% confidence limits for the difference in HbA1c between the 4mm PN and the 12.7mm PN was calculated. Equivalence limits for HbA1C were defined a-priori as +/- 0.4% units|Effect of 4 mm vs.12.7mm PN on HbA1c|-0.095|||||TWO_SIDED|95.0|-0.19|0.0|||Two one-sided 95% confidence limit|For equivalence testing, a 95% test is the same as two one-sided 95% confidence limits.||General linear models with baseline as a covariate, needle type, period, and randomization sequence as fixed effects, and subject as random effect were fit to the data.||-0.000|-0.190|
72362119|NCT03402217|144235829|SUPERIORITY|||||||0.383|||||||Wilcoxon (Mann-Whitney)|||Pre and post-score paired comparison.||||.383
72362120|NCT03402217|144235830|SUPERIORITY|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||Information pre-post paired comparison||||.001
72362121|NCT03402217|144235830|SUPERIORITY|||||||0.07|||||||Wilcoxon (Mann-Whitney)|||Motivation pre- and post-paired comparison.||||.07
72362122|NCT03402217|144235830|SUPERIORITY|||||||0.23|||||||Wilcoxon (Mann-Whitney)|||Behavior pre and post paired comparison||||.230
72362123|NCT02992288|144235868|SUPERIORITY|||||||0.2297||||||Linear dose-response shape: The multiple comparison procedures (MCP) approach was applied to calculate the adjusted one-sided one-sided p-values of the contrast test.|MCP-Mod method|Dose response relationship was assessed using the MCP-Mod method combining MCP principles with modeling techniques under model uncertainty.||||||0.2297
72362124|NCT02992288|144235868|SUPERIORITY|||||||0.4409||||||Sigmoidal Emax 1 dose-response shape: The MCP approach was applied to calculate the adjusted one-sided p-values of the contrast test.|MCP-Mod method|Dose response relationship was assessed using the MCP-Mod method combining MCP principles with modeling techniques under model uncertainty.||||||0.4409
72362125|NCT02992288|144235868|SUPERIORITY|||||||0.2842||||||Sigmoidal Emax 2 dose-response shape: The MCP approach was applied to calculate the adjusted one-sided p-values of the contrast test.|MCP-Mod method|Dose response relationship was assessed using the MCP-Mod method combining MCP principles with modeling techniques under model uncertainty.||||||0.2842
72362126|NCT02992288|144235868|SUPERIORITY|||||||0.2534||||||Emax dose-response shape: The MCP approach was applied to calculate the adjusted one-sided p-values of the contrast test.|MCP-Mod method|Dose response relationship was assessed using the MCP-Mod method combining MCP principles with modeling techniques under model uncertainty.||||||0.2534
72362127|NCT02992288|144235868|SUPERIORITY|||||||0.3842||||||Quadratic dose-response shape: The MCP approach was applied to calculate the adjusted one-sided p-values of the contrast test.|MCP-Mod method|Dose response relationship was assessed using the MCP-Mod method combining MCP principles with modeling techniques under model uncertainty.||||||0.3842
72362128|NCT02992288|144235869|SUPERIORITY|||||||0.8966||||||Linear dose-response shape: The MCP approach was applied to calculate the adjusted one-sided p-values of the contrast test.|MCP-Mod method|Dose response relationship was assessed using the MCP-Mod method combining MCP principles with modeling techniques under model uncertainty.||||||0.8966
72362129|NCT02992288|144235869|SUPERIORITY|||||||0.9233||||||Sigmoidal Emax 1 dose-response shape: The MCP approach was applied to calculate the adjusted one-sided p-values of the contrast test.|MCP-Mod method|Dose response relationship was assessed using the MCP-Mod method combining MCP principles with modeling techniques under model uncertainty.||||||0.9233
72362130|NCT02992288|144235869|SUPERIORITY|||||||0.9296||||||Sigmoidal Emax 2 dose-response shape: The MCP approach was applied to calculate the adjusted one-sided p-values of the contrast test.|MCP-Mod method|Dose response relationship was assessed using the MCP-Mod method combining MCP principles with modeling techniques under model uncertainty.||||||0.9296
72362131|NCT02992288|144235869|SUPERIORITY|||||||0.7357||||||Emax dose-response shape: The MCP approach was applied to calculate the adjusted one-sided p-values of the contrast test.|MCP-Mod method|Dose response relationship was assessed using the MCP-Mod method combining MCP principles with modeling techniques under model uncertainty.||||||0.7357
72362132|NCT02992288|144235869|SUPERIORITY|||||||0.9083||||||Quadratic dose-response shape: The MCP approach was applied to calculate the adjusted one-sided p-values of the contrast test.|MCP-Mod method|Dose response relationship was assessed using the MCP-Mod method combining MCP principles with modeling techniques under model uncertainty.||||||0.9083
72362133|NCT02992288|144235870|SUPERIORITY|||||||0.4596||||||Linear dose-response shape: The MCP approach was applied to calculate the adjusted one-sided p-values of the contrast test.|MCP-Mod method|Dose response relationship was assessed using the MCP-Mod method combining MCP principles with modeling techniques under model uncertainty.||||||0.4596
72362134|NCT02992288|144235870|SUPERIORITY|||||||0.7859||||||Sigmoidal Emax1 dose-response shape: The MCP approach was applied to calculate the adjusted one-sided p-values of the contrast test.|MCP-Mod method|Dose response relationship was assessed using the MCP-Mod method combining MCP principles with modeling techniques under model uncertainty.||||||0.7859
72362135|NCT02992288|144235870|SUPERIORITY|||||||0.5562||||||Sigmoidal Emax2 dose-response shape: The MCP approach was applied to calculate the adjusted one-sided p-values of the contrast test.|MCP-Mod method|Dose response relationship was assessed using the MCP-Mod method combining MCP principles with modeling techniques under model uncertainty.||||||0.5562
72368449|NCT01166282|144247080|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.4|||=|0.209|TWO_SIDED|95.0|-8.78|1.97|||1-way ANOVA|||||1.97|-8.78|=0.209
72362136|NCT02992288|144235870|SUPERIORITY|||||||0.5338||||||Emax dose-response shape: The MCP approach was applied to calculate the adjusted one-sided p-values of the contrast test.|MCP-Mod method|Dose response relationship was assessed using the MCP-Mod method combining MCP principles with modeling techniques under model uncertainty.||||||0.5338
72362137|NCT02992288|144235870|SUPERIORITY|||||||0.7303||||||Quadratic dose-response shape: The MCP approach was applied to calculate the adjusted one-sided p-values of the contrast test.|MCP-Mod method|Dose response relationship was assessed using the MCP-Mod method combining MCP principles with modeling techniques under model uncertainty.||||||0.7303
72362138|NCT02992288|144235871|SUPERIORITY|||||||0.5703||||||Linear dose-response shape: The MCP approach was applied to calculate the adjusted one-sided p-values of the contrast test.|MCP-Mod method|Dose response relationship was assessed using the MCP-Mod method combining MCP principles with modeling techniques under model uncertainty.||||||0.5703
72362139|NCT02992288|144235871|SUPERIORITY|||||||0.8253||||||Sigmoidal Emax1 dose-response shape: The MCP approach was applied to calculate the adjusted one-sided p-values of the contrast test.|MCP-Mod method|Dose response relationship was assessed using the MCP-Mod method combining MCP principles with modeling techniques under model uncertainty.||||||0.8253
72362140|NCT02992288|144235871|SUPERIORITY|||||||0.6506||||||Sigmoidal Emax2 dose-response shape: The MCP approach was applied to calculate the adjusted one-sided p-values of the contrast test.|MCP-Mod method|Dose response relationship was assessed using the MCP-Mod method combining MCP principles with modeling techniques under model uncertainty.||||||0.6506
72362141|NCT02992288|144235871|SUPERIORITY|||||||0.6923||||||Emax dose-response shape: The MCP approach was applied to calculate the adjusted one-sided p-values of the contrast test.|MCP-Mod method|Dose response relationship was assessed using the MCP-Mod method combining MCP principles with modeling techniques under model uncertainty.||||||0.6923
72362142|NCT02992288|144235871|SUPERIORITY|||||||0.8036||||||Quadratic dose-response shape: The MCP approach was applied to calculate the adjusted one-sided p-values of the contrast test.|MCP-Mod method|Dose response relationship was assessed using the MCP-Mod method combining MCP principles with modeling techniques under model uncertainty.||||||0.8036
72362143|NCT02992288|144235872|SUPERIORITY|||||||0.9955||||||Linear dose-response shape: The MCP approach was applied to calculate the adjusted one-sided p-values of the contrast test.|MCP-Mod method|Dose response relationship was assessed using the MCP-Mod method combining MCP principles with modeling techniques under model uncertainty.||||||0.9955
72362144|NCT02992288|144235872|SUPERIORITY|||||||0.9946||||||Sigmoidal Emax1 dose-response shape: The MCP approach was applied to calculate the adjusted one-sided p-values of the contrast test.|MCP-Mod method|Dose response relationship was assessed using the MCP-Mod method combining MCP principles with modeling techniques under model uncertainty.||||||0.9946
72362145|NCT02992288|144235872|SUPERIORITY|||||||0.9913||||||Sigmoidal Emax2 dose-response shape: The MCP approach was applied to calculate the adjusted one-sided p-values of the contrast test.|MCP-Mod method|Dose response relationship was assessed using the MCP-Mod method combining MCP principles with modeling techniques under model uncertainty.||||||0.9913
72362146|NCT02992288|144235872|SUPERIORITY|||||||0.9982||||||Emax dose-response shape: The MCP approach was applied to calculate the adjusted one-sided p-values of the contrast test.|MCP-Mod method|Dose response relationship was assessed using the MCP-Mod method combining MCP principles with modeling techniques under model uncertainty.||||||0.9982
72362147|NCT02992288|144235872|SUPERIORITY|||||||0.9959||||||Quadratic dose-response shape: The MCP approach was applied to calculate the adjusted one-sided p-values of the contrast test.|MCP-Mod method|Dose response relationship was assessed using the MCP-Mod method combining MCP principles with modeling techniques under model uncertainty.||||||0.9959
72362148|NCT03416985|144235876|OTHER|||||||0.1561||||||p \< 0.05 considered significant|ANOVA|||Compare groups with respect to plaque level after 30 days||||0.1561
72362149|NCT03416985|144235877|OTHER|||||||0.2161||||||p \< 0.05 considered significant|ANOVA|||Compare groups with respect to Gingival scores at 30 days||||0.2161
72362150|NCT02006472|144235878|SUPERIORITY||LSM difference|1.42||||0.3202|TWO_SIDED|95.0|-1.39|4.23|||Mixed Models Analysis|||||4.23|-1.39|0.3202
72362151|NCT02006472|144235878|SUPERIORITY||LSM difference|1.7||||0.2266|TWO_SIDED|95.0|-1.06|4.46|||Mixed Models Analysis|||||4.46|-1.06|0.2266
72362152|NCT02006472|144235878|SUPERIORITY||LSM difference|0.66||||0.6348|TWO_SIDED|95.0|-2.07|3.39|||Mixed Models Analysis|||||3.39|-2.07|0.6348
72362153|NCT02006472|144235878|SUPERIORITY||LSM difference|2.04||||0.1447|TWO_SIDED|95.0|-0.71|4.8|||Mixed Models Analysis|||||4.8|-0.71|0.1447
72362154|NCT02006472|144235880|SUPERIORITY||LSM difference|0.87||||0.0032|TWO_SIDED|95.0|0.29|1.45|||Mixed Models Analysis|||||1.45|0.29|0.0032
72362155|NCT02006472|144235880|SUPERIORITY||LSM difference|0.11||||0.7042|TWO_SIDED|95.0|-0.46|0.68|||Mixed Models Analysis|||||0.68|-0.46|0.7042
72362156|NCT02006472|144235880|SUPERIORITY||LSM difference|0.19||||0.5099|TWO_SIDED|95.0|-0.37|0.75|||Mixed Models Analysis|||||0.75|-0.37|0.5099
72362157|NCT02006472|144235880|SUPERIORITY||LSM difference|0.24||||0.4061|TWO_SIDED|95.0|-0.33|0.82|||Mixed Models Analysis|||||0.82|-0.33|0.4061
72362158|NCT02006472|144235881|SUPERIORITY||LSM difference|1.16||||0.0003|TWO_SIDED|95.0|0.54|1.78|||Mixed Models Analysis|||||1.78|0.54|0.0003
72362159|NCT02006472|144235882|SUPERIORITY|||||||0.003|||||||Chi-squared|||||||0.003
72362160|NCT02006472|144235883|SUPERIORITY||LSM difference|-0.0341||||0.0346|TWO_SIDED|95.0|-0.0658|-0.0026|||Mixed Models Analysis|||At Week 26||-0.0026|-0.0658|0.0346
72362161|NCT02006472|144235883|SUPERIORITY||LSM difference|-0.0444||||0.0305|TWO_SIDED|95.0|-0.0847|-0.0042|||Mixed Models Analysis|||At Week 52||-0.0042|-0.0847|0.0305
72362162|NCT00656513|144235888|SUPERIORITY|||||||0.45|||||||Wilcoxon (Mann-Whitney)|||An effect size of 0.50 was chosen for sample size calculation. On the basis of a 2-sided t test with alpha= 0.05 and 1 interim analysis, 130 patients were required for 80% statistical power. Adjustment by 10% for loss to follow-up and retrospective ineligibility of recruited study participants yielded a sample size of 144 patients. Actual power given only 96 patients was 68.6%||||0.45
72362163|NCT00656513|144235890|SUPERIORITY|||||||0.11||||||Two-sided test of values at 4 months.|Wilcoxon (Mann-Whitney)|||||||0.11
72362164|NCT00656513|144235890|SUPERIORITY|||||||0.31||||||Two-sided test of values at 6 months.|Wilcoxon (Mann-Whitney)|||||||0.31
72362165|NCT00656513|144235890|SUPERIORITY|||||||0.21||||||Two-sided test of values at 15 months.|Wilcoxon (Mann-Whitney)|||||||0.21
72362166|NCT00656513|144235891|SUPERIORITY|||||||0.35||||||4-month Physical Functioning score; two-sided test, significance level 0.05|Wilcoxon (Mann-Whitney)|||||||0.35
72362167|NCT00656513|144235891|SUPERIORITY|||||||0.78||||||4 months Pain/Discomfort score; two-sided test, significance level 0.05|Wilcoxon (Mann-Whitney)|||||||0.78
72362168|NCT00656513|144235891|SUPERIORITY|||||||0.12||||||4 months Personal/Psychological Functioning score; two-sided test, significance level 0.05|Wilcoxon (Mann-Whitney)|||||||0.12
72362169|NCT00656513|144235891|SUPERIORITY|||||||0.28||||||4-month Social Functioning score; two-sided test, significance level 0.05|Wilcoxon (Mann-Whitney)|||||||0.28
72362170|NCT00656513|144235891|SUPERIORITY|||||||0.98||||||6-month Physical Functioning score; two-sided test, significance level 0.05|Wilcoxon (Mann-Whitney)|||||||0.98
72362171|NCT00656513|144235891|SUPERIORITY|||||||0.28||||||6-month Pain/Discomfort score; two-sided test, significance level 0.05|Wilcoxon (Mann-Whitney)|||||||0.28
72362172|NCT00656513|144235891|SUPERIORITY|||||||0.13||||||6-month Personal/Psychological Functioning score; two-sided test, significance level 0.05|Wilcoxon (Mann-Whitney)|||||||0.13
72362173|NCT00656513|144235891|SUPERIORITY|||||||0.58||||||6-month Social Functioning score; two-sided test, significance level 0.05|Wilcoxon (Mann-Whitney)|||||||0.58
72362174|NCT00656513|144235891|SUPERIORITY|||||||0.88||||||9-month Physical Functioning score; two-sided test, significance level 0.05|Wilcoxon (Mann-Whitney)|||||||0.88
72362175|NCT00656513|144235891|SUPERIORITY|||||||0.09||||||9-month Pain/Discomfort score; two-sided test, significance level 0.05|Wilcoxon (Mann-Whitney)|||||||0.09
72362176|NCT00656513|144235891|SUPERIORITY|||||||0.49||||||9-month Personal/Psychological Functioning score; two-sided test, significance level 0.05|Wilcoxon (Mann-Whitney)|||||||0.49
72362177|NCT00656513|144235891|SUPERIORITY|||||||0.45||||||9-month Social Functioning score; two-sided test, significance level 0.05|Wilcoxon (Mann-Whitney)|||||||0.45
72362178|NCT00656513|144235891|SUPERIORITY|||||||0.45||||||15-month Physical Functioning; two-sided test, significance level 0.05|Wilcoxon (Mann-Whitney)|||||||0.45
72362179|NCT00656513|144235891|SUPERIORITY|||||||0.3||||||15-month Pain/Discomfort; two-sided test, significance level 0.05|Wilcoxon (Mann-Whitney)|||||||0.30
72362180|NCT00656513|144235891|SUPERIORITY|||||||0.48||||||15-month Personal/Psychological Functioning; two-sided test, significance level 0.05|Wilcoxon (Mann-Whitney)|||||||0.48
72362181|NCT00656513|144235891|SUPERIORITY|||||||0.68||||||15-month Social Functioning; two-sided test, significance level 0.05|Wilcoxon (Mann-Whitney)|||||||0.68
72362182|NCT00656513|144235892|SUPERIORITY|||||||0.97||||||4-month score; two-sided test, significance level 0.05|Wilcoxon (Mann-Whitney)|||||||0.97
72362183|NCT00656513|144235892|SUPERIORITY|||||||0.83||||||6-months; two-sided test, significance level 0.05|Wilcoxon (Mann-Whitney)|||||||0.83
72362184|NCT00656513|144235892|SUPERIORITY|||||||0.28||||||9-months; two-sided test, significance level 0.05|Wilcoxon (Mann-Whitney)|||||||0.28
72362185|NCT00656513|144235892|SUPERIORITY|||||||0.89||||||15-months; two-sided test, significance level 0.05|Wilcoxon (Mann-Whitney)|||||||0.89
72362186|NCT00656513|144235893|SUPERIORITY|||||||0.54||||||4-months; two-sided test, significance level 0.05|Wilcoxon (Mann-Whitney)|||||||0.54
72362187|NCT00656513|144235893|SUPERIORITY|||||||0.99||||||6-months; two-sided test, significance level 0.05|Wilcoxon (Mann-Whitney)|||||||0.99
72362188|NCT00656513|144235893|SUPERIORITY|||||||0.56||||||6-months; two-sided test, significance level 0.05|Wilcoxon (Mann-Whitney)|||||||0.56
72362189|NCT00656513|144235893|SUPERIORITY|||||||0.58||||||6-months; two-sided test, significance level 0.05|Wilcoxon (Mann-Whitney)|||||||0.58
72362190|NCT00656513|144235894|SUPERIORITY|||||||0.14||||||Two-sided test, significance level 0.05|t-test, 2 sided|||||||0.14
72362191|NCT01436149|144235913|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Mean|0.1|STANDARD_ERROR_OF_MEAN|0.96||0.883|TWO_SIDED|95.0|-1.7|2.0|||Mixed- effects Model for Repeat Measures|||||2.0|-1.7|0.883
72362192|NCT01436149|144235914|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Mean|-0.4|STANDARD_ERROR_OF_MEAN|0.69||0.576|TWO_SIDED|95.0|-1.8|1.0|||Mixed- effects Model for Repeat Measures|||||1.0|-1.8|0.576
72362193|NCT00573508|144235934|SUPERIORITY_OR_OTHER||Least Square Mean Difference|9.4|||<|0.0001||95.0|6.6|12.2|||ANCOVA|||Statistical Analysis applies to 'Change at End of Treatment'.||12.2|6.6|<0.0001
72362194|NCT00573508|144235935|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||Statistical Analysis applies to 'Change at Week 4', 'Change at Week 8' and 'Change at Week 12'.||||<.0001
72362195|NCT00573508|144235936|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-Value represents change from Baseline to Week 12.|ANCOVA|||Statistical Analysis applies to 'Change at Week 12'.||||<.0001
72362196|NCT00573508|144235937|SUPERIORITY_OR_OTHER|||||||0.0006||95.0|||||ANCOVA|||||||0.0006
72362197|NCT00573508|144235945|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-16.8|||<|0.0001||95.0|-22.1|-11.6|||ANCOVA|||Statistical Analysis applies to 'Change at EOT'.||-11.6|-22.1|<.0001
72362198|NCT01075243|144235966|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|3.71||||0.0009|TWO_SIDED|95.0|1.53|5.89|||ANCOVA|ANCOVA model included factors for treatment as a fixed effect and baseline assessment of pain intensity (VAS score) as a covariate.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered no difference in SPRID\^6h between Paracetamol 1000 mg caplet and Paracetamol 650 mg caplet.||5.89|1.53|0.0009
72362199|NCT01075243|144235966|SUPERIORITY_OR_OTHER||Adjusted Mean DIfference|11.33|||<|0.0001|TWO_SIDED|95.0|8.66|14.0|||ANCOVA|ANCOVA model included factors for treatment as a fixed effect and baseline assessment of pain intensity (VAS score) as a covariate.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered no difference in SPRID\^6h between Paracetamol 1000 mg caplet and placebo caplet.||14.00|8.66|<0.0001
72368450|NCT01166282|144247081|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.12|||=|0.509|TWO_SIDED|95.0|-4.49|2.26|||1-way ANOVA|||||2.26|-4.49|=0.509
72362200|NCT01075243|144235966|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|7.63|||<|0.0001||95.0|4.94|10.31|||ANCOVA|ANCOVA model included factors for treatment as a fixed effect and baseline assessment of pain intensity (VAS score) as a covariate.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered no difference in SPRID\^6h between Paracetamol 650 mg caplet and placebo caplet.||10.31|4.94|<0.0001
72362201|NCT00627393|144235982|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.19||||0.73|TWO_SIDED|95.0|0.44|3.2|||Regression, Logistic|Ordinary multiple logistic regression including treatment arm, infection strata, underlying disease, zubrod score, respiratory symptoms, and age.|Control group is the reference group. Model adjusted for infection strata, underlying disease, zubrod score, respiratory symptoms, and age.|||3.20|0.44|0.73
72362202|NCT00627393|144235985|SUPERIORITY_OR_OTHER||Log Rank P-Value|0.43||||0.43|TWO_SIDED|||||Competing risks analysis for time to GVHD for subjects with allogeneic HST. The sample size was very small (n=7 in the granulocyte group, and n=8 in the control group).|Competing Risks|||||||0.43
72362203|NCT00627393|144235990|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.293|STANDARD_ERROR_OF_MEAN|0.25885||0.35|TWO_SIDED|95.0|0.778|2.147|||Log Rank|Log-rank test to compare survival distributions between the control group and treatment group.|The control group is considered the reference group.|||2.147|0.778|0.35
72362204|NCT03094416|144236038|OTHER|Normal distribution of data was tested with Shapiro Wilks. Data were log transformed. A mixed model ANCOVA repeated measures model was used to test differences in means at Visit 4 vs baseline on original data. As covariates the following baseline variables were considered: Age, Sex, BMI and the prescribed Tirosint dosage (dose/Kg).|Mean Difference (Final Values)|-0.783797|STANDARD_ERROR_OF_MEAN|0.158271|<|0.0001|TWO_SIDED|||||level of significance p-value \< 0.05|Mixed Models Analysis|||||||<0.0001
72362205|NCT03094416|144236039|OTHER|Normal distribution of data was tested with Shapiro Wilks. Data were log transformed. A mixed model ANCOVA repeated measures model was used to test differences in means at Visit 4 vs baseline on original data. As covariates the following baseline variables were considered: Age, Sex, BMI and the prescribed Tirosint dosage (dose/Kg).|Mean Difference (Final Values)|0.037312|STANDARD_ERROR_OF_MEAN|0.026128||0.1607|TWO_SIDED|||||level of significance p-value \< 0.05|Mixed Models Analysis|||||||0.1607
72362206|NCT03094416|144236040|OTHER|Normal distribution of data was tested with Shapiro Wilks. Data were log transformed. A mixed model ANCOVA repeated measures model was used to test differences in means at Visit 4 vs baseline on original data. As covariates the following baseline variables were considered: Age, Sex, BMI and the prescribed Tirosint dosage (dose/Kg).|Mean Difference (Final Values)|3.397559|STANDARD_ERROR_OF_MEAN|4.174962||0.4204|TWO_SIDED|||||level of significance p-value \< 0.05|Mixed Models Analysis|||||||0.4204
72362207|NCT03094416|144236041|OTHER|Normal distribution of data was tested with Shapiro Wilks. Data were log transformed. A mixed model ANCOVA repeated measures model was used to test differences in means at Visit 4 vs baseline on original data. As covariates the following baseline variables were considered: Age, Sex, BMI and the prescribed Tirosint dosage (dose/Kg).|Mean Difference (Final Values)|0.055199|STANDARD_ERROR_OF_MEAN|0.019171||0.0062|TWO_SIDED|||||level of significance p-value \< 0.05|Mixed Models Analysis|||||||0.0062
72362208|NCT03094416|144236042|OTHER|"A mixed model ANCOVA repeated measures model was used to test differences in means at Visit 4 vs baseline on original data. As covariates the following baseline variables were considered: Age, Sex, BMI and the prescribed Tirosint dosage (dose/Kg).~Normal distribution of data was tested with Shapiro Wilks. No data transformation was done."|Mean Difference (Final Values)|0.100127|STANDARD_ERROR_OF_MEAN|0.048171||0.0438|TWO_SIDED|||||level of significance p-value \< 0.05|Mixed Models Analysis|||||||0.0438
72362209|NCT03094416|144236043|OTHER|Normal distribution of data was tested with Shapiro Wilks. Data were log transformed. A mixed model ANCOVA repeated measures model was used to test differences in means at Visit 4 vs baseline on original data. As covariates the following baseline variables were considered: Age, Sex, BMI and the prescribed Tirosint dosage (dose/Kg).|Mean Difference (Final Values)|-0.216479|STANDARD_ERROR_OF_MEAN|0.093366||0.0254|TWO_SIDED|||||level of significance p-value \< 0.05|Mixed Models Analysis|||||||0.0254
72362210|NCT03094416|144236044|OTHER|Normal distribution of data was tested with Shapiro Wilks. Data were log transformed. A mixed model ANCOVA repeated measures model was used to test differences in means at Visit 4 vs baseline on original data. As covariates the following baseline variables were considered: Age, Sex, BMI and the prescribed Tirosint dosage (dose/Kg).|Mean Difference (Final Values)|0.011187|STANDARD_ERROR_OF_MEAN|0.036679||0.7619|TWO_SIDED|||||level of significance p-value \< 0.05|Mixed Models Analysis|||||||0.7619
72362211|NCT03094416|144236045|OTHER|Normal distribution of data was tested with Shapiro Wilks. Data were log transformed. A mixed model ANCOVA repeated measures model was used to test differences in means at Visit 4 vs baseline on original data. As covariates the following baseline variables were considered: Age, Sex, BMI and the prescribed Tirosint dosage (dose/Kg).|Mean Difference (Final Values)|-0.121537|STANDARD_ERROR_OF_MEAN|0.064264||0.0655|TWO_SIDED|||||level of significance p-value \< 0.05|Mixed Models Analysis|||||||0.0655
72362212|NCT03094416|144236046|OTHER|Normal distribution of data was tested with Shapiro Wilks. Data were log transformed. A mixed model ANCOVA repeated measures model was used to test differences in means at Visit 4 vs baseline on original data. As covariates the following baseline variables were considered: Age, Sex, BMI and the prescribed Tirosint dosage (dose/Kg).|Mean Difference (Final Values)|0.031636|STANDARD_ERROR_OF_MEAN|0.053033||0.5542|TWO_SIDED|||||level of significance p-value \< 0.05|Mixed Models Analysis|||||||0.5542
72368451|NCT01166282|144247082|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|11.0|||=|0.514|TWO_SIDED|95.0|-18.5|40.5|||Fisher Exact|||||40.5|-18.5|=0.514
72368452|NCT01166282|144247083|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|27.7|||=|0.111|TWO_SIDED|95.0|-2.0|57.5|||Fisher Exact|||||57.5|-2.0|=0.111
72362213|NCT03094416|144236047|OTHER|Normal distribution of data was tested with Shapiro Wilks. Data were log transformed. A mixed model ANCOVA repeated measures model was used to test differences in means at Visit 4 vs baseline on original data. As covariates the following baseline variables were considered: Age, Sex, BMI and the prescribed Tirosint dosage (dose/Kg).|Mean Difference (Final Values)|0.019322|STANDARD_ERROR_OF_MEAN|0.046827||0.682|TWO_SIDED|||||level of significance p-value \< 0.05|Mixed Models Analysis|||||||0.6820
72362214|NCT03094416|144236048|OTHER|Normal distribution of data was tested with Shapiro Wilks. Data were log transformed. A mixed model ANCOVA repeated measures model was used to test differences in means at Visit 4 vs baseline on original data. As covariates the following baseline variables were considered: Age, Sex, BMI and the prescribed Tirosint dosage (dose/Kg).|Mean Difference (Final Values)|-0.049243|STANDARD_ERROR_OF_MEAN|0.024025||0.0468|TWO_SIDED|||||level of significance p-value \< 0.05|Mixed Models Analysis|||||||0.0468
72362215|NCT03094416|144236049|OTHER|"A mixed model ANCOVA repeated measures model was used to test differences in means at Visit 4 vs baseline on original data. As covariates the following baseline variables were considered: Age, Sex, BMI and the prescribed Tirosint dosage (dose/Kg).~Normal distribution of data was tested with Shapiro Wilks. No data transformation was done."|Mean Difference (Final Values)|-0.213171|STANDARD_ERROR_OF_MEAN|0.088103||0.0203|TWO_SIDED|||||level of significance p-value \< 0.05|Mixed Models Analysis|||||||0.0203
72362216|NCT03094416|144236050|OTHER|"A mixed model ANCOVA repeated measures model was used to test differences in means at Visit 4 vs baseline on original data. As covariates the following baseline variables were considered: Age, Sex, BMI and the prescribed Tirosint dosage (dose/Kg).~Normal distribution of data was tested with Shapiro Wilks. No data transformation was done."|Mean Difference (Final Values)|-0.030904|STANDARD_ERROR_OF_MEAN|0.038699||0.4291|TWO_SIDED|||||level of significance p-value \< 0.05|Mixed Models Analysis|||||||0.4291
72362217|NCT03094416|144236051|OTHER|Normal distribution of data was tested with Shapiro Wilks. Data were log transformed. A mixed model ANCOVA repeated measures model was used to test differences in means at Visit 4 vs baseline on original data. As covariates the following baseline variables were considered: Age, Sex, BMI and the prescribed Tirosint dosage (dose/Kg).|Mean Difference (Final Values)|0.025502|STANDARD_ERROR_OF_MEAN|0.047802||0.5967|TWO_SIDED|||||level of significance p-value \< 0.05|Mixed Models Analysis|||||||0.5967
72362218|NCT03341299|144236095|SUPERIORITY||Ratio of geometric least square means|0.991||||0.7734|TWO_SIDED|95.0|0.932|1.05|||Mixed Models Analysis|||||1.05|0.932|0.7734
72362219|NCT03341299|144236096|SUPERIORITY||difference in LS means|-14.5||||0.719|TWO_SIDED|95.0|-94.38|65.38|||Mixed Models Analysis|||||65.38|-94.38|0.7190
72362220|NCT03474588|144236183|SUPERIORITY|||||||0.3||||||Presented is the p value for the interaction between time and treatment.|Regression, Linear|Random Effects Regression Models (RERM), time was log transformed to account for expectation of greater change closer to baseline||||||0.30
72362221|NCT03474588|144236184|SUPERIORITY||Mean Difference (Net)|1.39|STANDARD_ERROR_OF_MEAN|0.94||0.14|TWO_SIDED|95.0|-0.46|3.24||presented is the p value for the interaction of treatment and time in the model.|Regression, Linear|||Random Effects Regression Model (RERM), included in the model were treatment, time and the interaction of time and treatment.||3.24|-0.46|0.14
72362222|NCT03474588|144236185|SUPERIORITY|||||||0.097|||||||ANOVA|||||||0.097
72362223|NCT03474588|144236186|SUPERIORITY|||||||0.802|||||||Chi-squared|||||||0.802
72362224|NCT01607957|144236201|SUPERIORITY||Hazard Ratio (HR)|0.68|||<|0.0001|TWO_SIDED|95.0|0.58|0.81|||Stratified log-rank test|||||0.81|0.58|<0.0001
72362225|NCT01607957|144236202|SUPERIORITY||Hazard Ratio (HR)|0.48|||<|0.0001|TWO_SIDED|95.0|0.41|0.57|||Stratified log-rank test|||||0.57|0.41|<0.0001
72362226|NCT04607005|144236218|SUPERIORITY||Mean Difference (Final Values)|-0.43||||0.067|TWO_SIDED|95.0|-0.89|0.03||p-Value was based on a mixed model repeated measures (MMRM) Model.|Mixed Models Analysis|||||0.03|-0.89|0.067
72362227|NCT04607005|144236219|SUPERIORITY||Mean Difference (Final Values)|-0.47||||0.043|TWO_SIDED|95.0|-0.92|-0.02||p-Value was based on a mixed model repeated measures (MMRM) Model.|Mixed Models Analysis|||||-0.02|-0.92|0.043
72362228|NCT04607005|144236220|SUPERIORITY||Mean Difference (Final Values)|-1.43||||0.003|TWO_SIDED|95.0|-2.37|-0.5||p-Value was based on a mixed model repeated measures (MMRM) Model.|Mixed Models Analysis|||||-0.50|-2.37|0.003
72362229|NCT04607005|144236221|SUPERIORITY||Mean Difference (Final Values)|-1.43||||0.002|TWO_SIDED|95.0|-2.35|-0.51||p-Value was based on a mixed model repeated measures (MMRM) Model.|Mixed Models Analysis|||||-0.51|-2.35|0.002
72362230|NCT04607005|144236222|SUPERIORITY||Mean Difference (Final Values)|-1.54||||0.003|TWO_SIDED|95.0|-2.52|-0.55||p-Value was based on a mixed model repeated measures (MMRM) Model.|Mixed Models Analysis|||||-0.55|-2.52|0.003
72362231|NCT04607005|144236223|SUPERIORITY||Mean Difference (Final Values)|-1.54||||0.002|TWO_SIDED|95.0|-2.51|-0.57||p-Value was based on a mixed model repeated measures (MMRM) Model.|Mixed Models Analysis|||||-0.57|-2.51|0.002
72362232|NCT04607005|144236224|SUPERIORITY||Mean Difference (Final Values)|-1.63||||0.012|TWO_SIDED|95.0|-2.9|-0.37||p-Value was based on a ANCOVA Model.|ANCOVA|||||-0.37|-2.90|0.012
72362233|NCT04607005|144236225|SUPERIORITY||Mean Difference (Final Values)|-1.67||||0.009|TWO_SIDED|95.0|-2.93|-0.42||p-Value was based on a ANCOVA Model.|ANCOVA|||||-0.42|-2.93|0.009
72362234|NCT04607005|144236226|SUPERIORITY||Mean Difference (Final Values)|-1.17||||0.005|TWO_SIDED|95.0|-1.99|-0.35||p-Value was based on a mixed model repeated measures (MMRM) Model.|Mixed Models Analysis|||||-0.35|-1.99|0.005
72362235|NCT04607005|144236227|SUPERIORITY||Mean Difference (Final Values)|-1.21||||0.004|TWO_SIDED|95.0|-2.02|-0.4||p-Value was based on a mixed model repeated measures (MMRM) Model.|Mixed Models Analysis|||||-0.40|-2.02|0.004
72362236|NCT04607005|144236228|SUPERIORITY||Mean Difference (Final Values)|-10.63||||0.01|TWO_SIDED|95.0|-18.68|-2.57||p-Value was based on a mixed model repeated measures (MMRM) Model.|Mixed Models Analysis|||||-2.57|-18.68|0.010
72362237|NCT04607005|144236229|SUPERIORITY||Mean Difference (Final Values)|-11.39||||0.004|TWO_SIDED|95.0|-19.19|-3.6||p-Value was based on a mixed model repeated measures (MMRM) Model.|Mixed Models Analysis|||||-3.60|-19.19|0.004
72362238|NCT04607005|144236230|SUPERIORITY||Mean Difference (Final Values)|-0.82||||0.009|TWO_SIDED|95.0|-1.43|-0.21||p-Value was based on a mixed model repeated measures (MMRM) Model.|Mixed Models Analysis|||||-0.21|-1.43|0.009
72362239|NCT04607005|144236231|SUPERIORITY||Mean Difference (Final Values)|-0.89||||0.004|TWO_SIDED|95.0|-1.49|-0.28||p-Value was based on a mixed model repeated measures (MMRM) Model.|Mixed Models Analysis|||||-0.28|-1.49|0.004
72368453|NCT01166282|144247084|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|34.8|||=|0.031|TWO_SIDED|95.0|8.1|61.6|||Fisher Exact|||||61.6|8.1|=0.031
72362240|NCT04607005|144236232|SUPERIORITY||Hazard Ratio (HR)|0.49||||0.026|TWO_SIDED|95.0|0.26|0.92||p-Value was based on Cox Proportional Hazards Model.|Cox proportional hazards model|||||0.92|0.26|0.026
72362241|NCT04607005|144236233|SUPERIORITY||Hazard Ratio (HR)|0.47||||0.018|TWO_SIDED|95.0|0.25|0.88||p-Value was based on Cox Proportional Hazards Model.|Cox proportional hazards model|||||0.88|0.25|0.018
72362242|NCT03919773|144236234|SUPERIORITY|||||||0.629|||||||Kruskal-Wallis|||Intention-to-treat analysis||||0.629
72362243|NCT03919773|144236235|SUPERIORITY|||||||0.718|||||||Fisher Exact|||comparison of proportion with positive treatment response (as defined) in IVIG group compared to albumin||||0.718
72362244|NCT03589859|144236246|OTHER|This was a physiology study, not a treatment trial. The test was for a change in VOR gain.|||||<|0.001|||||||Mixed Models Analysis|||A linear mixed effects model was used to compare pre- and post-training VOR gains||||<0.001
72362245|NCT04966013|144236249|SUPERIORITY||Hazard Ratio (HR)|1.005||||0.9784|TWO_SIDED|95.0|0.717|1.408|||Regression, Cox|||Log Rank Test and Cox PH Regression analyses were performed unstratified||1.408|0.717|0.9784
72362246|NCT04966013|144236250|SUPERIORITY||Hazard Ratio (HR)|1.388||||0.1512|TWO_SIDED|95.0|0.887|2.172||Log Rank Test and Cox PH Regression analyses were performed unstratified|Regression, Cox|||||2.172|0.887|0.1512
72362247|NCT05010707|144236261|SUPERIORITY|||||||0.005|||||||Mixed Models Analysis|||Time x treatment (month 0, and 1 month)||||0.005
72362248|NCT05010707|144236261|SUPERIORITY||Mean Difference (Final Values)|-225.3||||0.02|TWO_SIDED|95.0|-421.71|-28.79|||Mixed Models Analysis|||||-28.79|-421.71|0.02
72362249|NCT05010707|144236261|SUPERIORITY||Mean Difference (Final Values)|-250.6||||0.009|TWO_SIDED|95.0|-447.1|-54.19|||Mixed Models Analysis|||||-54.19|-447.10|0.009
72362250|NCT05010707|144236262|SUPERIORITY|||||||0.951|||||||Mixed Models Analysis|||Time x treatment (month 0 and month 1)||||0.951
72362251|NCT05010707|144236262|SUPERIORITY||Mean Difference (Final Values)|-1.6||||1|TWO_SIDED|95.0|-29.6|26.4|||Mixed Models Analysis||The mean difference is computed using the model based estimates rather than from the raw data.|||26.4|-29.6|1
72362252|NCT05010707|144236262|SUPERIORITY||Mean Difference (Final Values)|-7.1||||1|TWO_SIDED|95.0|-35.1|20.8|||Mixed Models Analysis||The mean difference is computed using the model based estimates rather than from the raw data.|||20.8|-35.1|1
72362253|NCT05010707|144236263|SUPERIORITY|||||||0.004|||||||Mixed Models Analysis|||Time x treatment (month 0 and month 1)||||0.004
72362254|NCT05010707|144236263|SUPERIORITY||Mean Difference (Final Values)|-280.4||||0.005|TWO_SIDED|95.0|-487.3|-73.5|||Mixed Models Analysis|||||-73.5|-487.3|0.005
72362255|NCT05010707|144236263|SUPERIORITY||Mean Difference (Final Values)|-204.1||||0.054|TWO_SIDED|95.0|-411.1|2.8|||Mixed Models Analysis|||||2.8|-411.1|0.054
72362256|NCT03518086|144236264|SUPERIORITY||Risk Difference (RD)|11.1||||6e-05|TWO_SIDED|99.875|3.2|19.1|||Cochran-Mantel-Haenszel|||||19.1|3.2|0.00006
72362257|NCT03518086|144236265|SUPERIORITY||Risk Difference (RD)|21.4|||<|1e-05|TWO_SIDED|99.875|10.8|32.0|||Cochran-Mantel-Haenszel|||||32.0|10.8|<0.00001
72362258|NCT03518086|144236266|SUPERIORITY||Risk Difference (RD)|15.4|||<|1e-05|TWO_SIDED|99.875|6.3|24.5|||Cochran-Mantel-Haenszel|||||24.5|6.3|<0.00001
72362259|NCT03518086|144236267|SUPERIORITY||Risk Difference (RD)|17.5|||<|0.001|TWO_SIDED|99.875|11.4|23.6|||Cochran-Mantel-Haenszel|||||23.6|11.4|<0.001
72362260|NCT03518086|144236268|SUPERIORITY||Risk Difference (RD)|20.2|||<|0.001|TWO_SIDED|95.0|13.8|26.6|||Cochran-Mantel-Haenszel|||||26.6|13.8|<0.001
72362261|NCT03518086|144236269|SUPERIORITY||Risk Difference (RD)|13.7|||<|0.001|TWO_SIDED|95.0|8.6|18.7|||Cochran-Mantel-Haenszel|||||18.7|8.6|<0.001
72362262|NCT03518086|144236270|SUPERIORITY||Risk Difference (RD)|19.5|||<|1e-05|TWO_SIDED|95.0|13.2|25.8|||Cochran-Mantel-Haenszel|||||25.8|13.2|<0.00001
72362263|NCT03518086|144236271|SUPERIORITY||Mean Difference (Net)|-0.95|STANDARD_ERROR_OF_MEAN|0.159|<|1e-05|TWO_SIDED|99.875|-1.47|-0.44|||Mixed Models Analysis||The confidence interval of 99.875 % was chosen to match the significance level.|||-0.44|-1.47|<0.00001
72362264|NCT03518086|144236272|SUPERIORITY||Mean Difference (Net)|13.21|STANDARD_ERROR_OF_MEAN|2.005|<|0.001|TWO_SIDED|95.0|9.28|17.15|||ANCOVA|||||17.15|9.28|<0.001
72362265|NCT03518086|144236273|SUPERIORITY||Mean Difference (Net)|-935.6|STANDARD_ERROR_OF_MEAN|218.09|<|0.001|TWO_SIDED|95.0|-1363.64|-507.55|||Mixed Models Analysis|||||-507.55|-1363.64|<0.001
72362266|NCT00626106|144236298|SUPERIORITY||Mean Difference (Final Values)|-0.02||||0.542|TWO_SIDED|95.0|-0.11|0.07|||ANCOVA|||||0.07|-0.11|0.542
72362267|NCT04567628|144236307|OTHER||||||=|0.003|||||||Spearman's Rank Correlation|||||||=0.003
72362268|NCT04567628|144236308|OTHER||||||=|0.25||||||A two-sided p-value of \<0.05 was considered statistically significant.|Log Rank|||||||=0.25
72362269|NCT04567628|144236311|OTHER||||||<|0.001||||||A two-sided p-value of \<0.05 was considered statistically significant.|Log Rank|||||||<0.001
72362270|NCT04567628|144236313|OTHER||||||<|0.0001||||||A two-sided p-value of \<0.05 was considered statistically significant.|Log Rank|||||||<0.0001
72362271|NCT00385671|144236337|NON_INFERIORITY_OR_EQUIVALENCE|Basis of non-inferiority margin (maximum disadvantage for duloxetine compared to pregabalin not considered meaningful): In 3 previous placebo-controlled trials of duloxetine in DPNP, in the subgroup of patients that had been treated with gabapentin prior to entry, the estimated mean change in pain at Week 12 was -2.74 for duloxetine and -1.09 for placebo, an advantage of about 1.65. The non-inferiority margin represents about half of this previous treatment effect in a similar population.|Mean Difference (Final Values)|0.49||||0.076|TWO_SIDED|95.0|-0.05|1.04||P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week, Kenward-Roger approximation was used.||Null hypothesis: no difference in mean change from baseline to 12 weeks in weekly mean of daily 24 hour average pain score between pregabalin \& duloxetine treatments. Sample size: 125 participants/treatment, 6% increase for 400 planned enrollees. 92% power with 1-sided 97.5% confidence interval; mean change in duloxetine group, -2.7; in pregabalin group, -2.5; standard deviation, 2.3; margin of non-inferiority: -0.8.||1.04|-0.05|0.076
72368454|NCT00439517|144247111|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.677||||0.0048|TWO_SIDED|95.0|0.515|0.889|||Stratified log rank|Kaplan-Meier method was used to estimate median PFS time. HR was calculated using Cox proportional hazards model stratified by randomization strata.||||0.889|0.515|0.0048
72362272|NCT00385671|144236338|NON_INFERIORITY_OR_EQUIVALENCE|Basis of non-inferiority margin (maximum disadvantage for duloxetine compared to pregabalin not considered meaningful): In 3 previous placebo-controlled trials of duloxetine in DPNP, in the subgroup of patients that had been treated with gabapentin prior to entry, the estimated mean change in pain at Week 12 was -2.74 for duloxetine and -1.09 for placebo, an advantage of about 1.65. The non-inferiority margin represents about half of this previous treatment effect in a similar population.|Mean Difference (Final Values)|0.23||||0.417|TWO_SIDED|95.0|-0.32|0.78||P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week, Kenward-Roger approximation was used.||Null hypothesis: no difference in mean change from baseline to 12 weeks in weekly mean of daily 24 hour average pain score between duloxetine \& duloxetine+gabapentin treatments. Sample size: 125 participants/treatment, 6% increase for 400 planned enrollees. 92% power with 1-sided 97.5% confidence interval; mean change in duloxetine group, -2.7; in pregabalin group, -2.5; standard deviation, 2.3; margin of non-inferiority: -0.8.||0.78|-0.32|0.417
72362273|NCT00385671|144236339|SUPERIORITY_OR_OTHER|||||||0.463||95.0||||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in Weekly mean of nighttime pain severity.||||0.463
72362274|NCT00385671|144236339|SUPERIORITY_OR_OTHER|||||||0.52||95.0||||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in Weekly mean of nighttime pain severity.||||0.520
72362275|NCT00385671|144236339|SUPERIORITY_OR_OTHER|||||||0.463||95.0||||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in Weekly mean of nighttime pain severity.||||0.463
72362276|NCT00385671|144236340|SUPERIORITY_OR_OTHER|||||||0.389||95.0||||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in weekly mean of the daily worst pain severity score.||||0.389
72362277|NCT00385671|144236340|SUPERIORITY_OR_OTHER|||||||0.126||95.0||||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in weekly mean of the daily worst pain severity score.||||0.126
72362278|NCT00385671|144236340|SUPERIORITY_OR_OTHER|||||||0.489||95.0||||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in weekly mean of the daily worst pain severity score.||||0.489
72362279|NCT00385671|144236341|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.07||||0.602|TWO_SIDED|95.0|-0.2|0.35||P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|Analysis of Covariance model and t-tests: Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used.||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in CGI severity.||0.35|-0.20|0.602
72362280|NCT00385671|144236341|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||0.469|TWO_SIDED|95.0|-0.17|0.37||P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in CGI severity.||0.37|-0.17|0.469
72362281|NCT00385671|144236341|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.03||||0.841|TWO_SIDED|95.0|-0.24|0.3||P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in CGI severity.||0.30|-0.24|0.841
72362282|NCT00385671|144236342|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2||||0.276|TWO_SIDED|95.0|-0.16|0.55||P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Variance model and t-tests:~Endpoint = InvestigatorGroup + Treatment. Last-observation-carried-forward imputation was implemented."||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in PGI-Improvement at 12 weeks.||0.55|-0.16|0.276
72362283|NCT00385671|144236342|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.02||||0.929|TWO_SIDED|95.0|-0.33|0.37||P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Variance model and t-tests:~Endpoint = InvestigatorGroup + Treatment. Last-observation-carried-forward imputation was implemented."||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in PGI-Improvement at 12 weeks.||0.37|-0.33|0.929
72362284|NCT00385671|144236342|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.18||||0.313|TWO_SIDED|95.0|-0.53|0.17||P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Variance model and t-tests:~Endpoint = InvestigatorGroup + Treatment. Last-observation-carried-forward imputation was implemented."||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in PGI-Improvement at 12 weeks.||0.17|-0.53|0.313
72362285|NCT00385671|144236343|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.49||||0.078|TWO_SIDED|95.0|-0.06|1.04||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in BPI-Severity: 24-hour average pain.||1.04|-0.06|0.078
72362286|NCT00385671|144236343|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.64||||0.025|TWO_SIDED|95.0|0.08|1.2||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in BPI-Severity: 24-hour average pain.||1.20|0.08|0.025
72362287|NCT00385671|144236343|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.15||||0.602|TWO_SIDED|95.0|-0.41|0.7||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in BPI-Severity: 24-hour average pain.||0.70|-0.41|0.602
72362288|NCT00385671|144236344|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3||||0.353|TWO_SIDED|95.0|-0.34|0.94||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in BPI-severity: worst pain.||0.94|-0.34|0.353
72362289|NCT00385671|144236344|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.69||||0.039|TWO_SIDED|95.0|0.03|1.34||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in BPI-severity: worst pain.||1.34|0.03|0.039
72362290|NCT00385671|144236344|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.39||||0.244|TWO_SIDED|95.0|-0.27|1.04||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in BPI-Severity: Worst Pain.||1.04|-0.27|0.244
72362291|NCT00385671|144236345|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.28||||0.298|TWO_SIDED|95.0|-0.25|0.8||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in BPI-Severity: Least Pain.||0.80|-0.25|0.298
72362292|NCT00385671|144236345|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.28||||0.304|TWO_SIDED|95.0|-0.25|0.81||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in BPI-Severity: Least Pain.||0.81|-0.25|0.304
72362293|NCT00385671|144236345|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.989|TWO_SIDED|95.0|-0.53|0.54||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in BPI-severity: least pain.||0.54|-0.53|0.989
72362294|NCT00385671|144236346|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.41||||0.145|TWO_SIDED|95.0|-0.14|0.97||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in BPI-severity: pain right now.||0.97|-0.14|0.145
72362295|NCT00385671|144236346|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.46||||0.112|TWO_SIDED|95.0|-0.11|1.03||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in BPI-severity: pain right now.||1.03|-0.11|0.112
72362296|NCT00385671|144236346|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.05||||0.865|TWO_SIDED|95.0|-0.52|0.62||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in Weekly mean of nighttime pain severity.||0.62|-0.52|0.865
72362297|NCT00385671|144236347|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.35||||0.263|TWO_SIDED|95.0|-0.26|0.95||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in BPI-interference with general activity.||0.95|-0.26|0.263
72362298|NCT00385671|144236347|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.86||||0.007|TWO_SIDED|95.0|0.24|1.49||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in BPI-interference with general activity.||1.49|0.24|0.007
72362299|NCT00385671|144236347|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.52||||0.102|TWO_SIDED|95.0|-0.1|1.13||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in BPI-interference with general activity.||1.13|-0.10|0.102
72362300|NCT00385671|144236348|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.03||||0.922|TWO_SIDED|95.0|-0.61|0.55||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in BPI-interference with mood.||0.55|-0.61|0.922
72362301|NCT00385671|144236348|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.39||||0.195|TWO_SIDED|95.0|-0.2|0.99||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in BPI-interference with mood.||0.99|-0.20|0.195
72362302|NCT00385671|144236348|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.42||||0.162|TWO_SIDED|95.0|-0.17|1.02||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in BPI-interference with mood.||1.02|-0.17|0.162
72362303|NCT00385671|144236349|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.21||||0.541|TWO_SIDED|95.0|-0.46|0.87||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in BPI-interference with walking ability.||0.87|-0.46|0.541
72362304|NCT00385671|144236349|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.68||||0.051|TWO_SIDED|95.0|0.0|1.36||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in BPI-interference with walking ability.||1.36|-0.00|0.051
72362305|NCT00385671|144236349|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.47||||0.173|TWO_SIDED|95.0|-0.21|1.15||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in BPI-interference with walking ability.||1.15|-0.21|0.173
72368455|NCT00439517|144247112|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.756||||0.016|TWO_SIDED|95.0|1.11|2.777|||Cochran-Mantel-Haenszel|Stratified odds ratio and Cochran-Mantel- Haenszel (CMH) statistics were calculated considering the randomization strata.||||2.777|1.110|0.016
72362306|NCT00385671|144236350|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.25||||0.451|TWO_SIDED|95.0|-0.4|0.9||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in Weekly BPI-interference with normal work.||0.90|-0.40|0.451
72362307|NCT00385671|144236350|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.24||||0.485|TWO_SIDED|95.0|-0.43|0.9||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in BPI-interference with normal work.||0.90|-0.43|0.485
72362308|NCT00385671|144236350|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01||||0.969|TWO_SIDED|95.0|-0.68|0.65||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in BPI-interference with normal work.||0.65|-0.68|0.969
72362309|NCT00385671|144236351|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2||||0.479|TWO_SIDED|95.0|-0.36|0.76||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in Weekly BPI-interference with relations with other people.||0.76|-0.36|0.479
72362310|NCT00385671|144236351|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3||||0.301|TWO_SIDED|95.0|-0.27|0.87||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in BPI-interference with relations with other people.||0.87|-0.27|0.301
72362311|NCT00385671|144236351|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||0.731|TWO_SIDED|95.0|-0.47|0.67||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in BPI-interference with relations with other people.||0.67|-0.47|0.731
72362312|NCT00385671|144236352|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.21||||0.528|TWO_SIDED|95.0|-0.45|0.87||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in BPI-interference with sleep.||0.87|-0.45|0.528
72362313|NCT00385671|144236352|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.17||||0.626|TWO_SIDED|95.0|-0.84|0.51||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in BPI-interference with sleep.||0.51|-0.84|0.626
72362314|NCT00385671|144236352|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.38||||0.27|TWO_SIDED|95.0|-1.06|0.3||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in BPI-interference with sleep.||0.30|-1.06|0.270
72362315|NCT00385671|144236353|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.52||||0.098|TWO_SIDED|95.0|-0.1|1.13||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in BPI-interference with enjoyment of life.||1.13|-0.10|0.098
72362316|NCT00385671|144236353|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.28||||0.383|TWO_SIDED|95.0|-0.35|0.9||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in BPI-interference with enjoyment of life.||0.90|-0.35|0.383
72368456|NCT00439517|144247113|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.855||||0.3797|TWO_SIDED|95.0|0.603|1.213|||Stratified log rank|Kaplan-Meier method was used to estimate median OS time. HR was calculated using Cox proportional hazards model stratified by randomization strata.||||1.213|0.603|0.3797
72362317|NCT00385671|144236353|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.24||||0.452|TWO_SIDED|95.0|-0.86|0.39||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in BPI-interference with enjoyment of life.||0.39|-0.86|0.452
72362318|NCT00385671|144236354|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.28||||0.309|TWO_SIDED|95.0|-0.26|0.82||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in BPI mean interference score.||0.82|-0.26|0.309
72362319|NCT00385671|144236354|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.38||||0.174|TWO_SIDED|95.0|-0.17|0.93||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in BPI mean interference score.||0.93|-0.17|0.174
72362320|NCT00385671|144236354|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||0.717|TWO_SIDED|95.0|-0.45|0.65||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in BPI mean interference score.||0.65|-0.45|0.717
72362321|NCT00385671|144236355|SUPERIORITY_OR_OTHER|||||||0.975||95.0||||P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Mantel Haenszel|Treatments were compared with stratification defined by InvestigatorGroup. Last-observation-carried-forward imputation was implemented.||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the number of participants with ≥ 30% reduction in the weekly mean 24 hour average pain score at 12 weeks.||||0.975
72362322|NCT00385671|144236355|SUPERIORITY_OR_OTHER|||||||0.448||95.0||||P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Mantel Haenszel|Treatments were compared with stratification defined by InvestigatorGroup. Last-observation-carried-forward imputation was implemented.||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the number of participants with ≥ 30% reduction in the weekly mean 24 hour average pain score at 12 weeks.||||0.448
72362323|NCT00385671|144236355|SUPERIORITY_OR_OTHER|||||||0.28||95.0||||P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Mantel Haenszel|Treatments were compared with stratification defined by InvestigatorGroup. Last-observation-carried-forward imputation was implemented.||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the number of participants with ≥ 30% reduction in the weekly mean 24 hour average pain score at 12 weeks.||||0.280
72362324|NCT00385671|144236356|SUPERIORITY_OR_OTHER|||||||0.548||95.0||||P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Mantel Haenszel|Treatments were compared with stratification defined by InvestigatorGroup. Last-observation-carried-forward imputation was implemented.||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the number of patients with a reduction of ≥ 50% in Weekly mean of 24 hour average pain score.||||0.548
72362325|NCT00385671|144236356|SUPERIORITY_OR_OTHER|||||||0.599||95.0||||P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Mantel Haenszel|Treatments were compared with stratification defined by InvestigatorGroup. Last-observation-carried-forward imputation was implemented.||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the number of patients with a reduction of ≥ 50% in Weekly mean of 24 hour average pain score.||||0.599
72362326|NCT00385671|144236356|SUPERIORITY_OR_OTHER|||||||1||95.0||||P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Mantel Haenszel|Treatments were compared with stratification defined by InvestigatorGroup. Last-observation-carried-forward imputation was implemented.||Tested was the null-hypothesis that there would be no difference in the number of patients with a reduction of ≥ 50% in Weekly mean of 24 hour average pain score.||||1.00
72362327|NCT00385671|144236357|SUPERIORITY_OR_OTHER|||||||0.905||95.0||||P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Mantel Haenszel|Treatments were compared with stratification defined by InvestigatorGroup. Last-observation-carried-forward imputation was implemented.||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the number of Participants with a ≥ 2-points reduction on the weekly average of the daily 24-hour average pain scale at 12 Weeks.||||0.905
72362328|NCT00385671|144236357|SUPERIORITY_OR_OTHER|||||||0.368||95.0||||P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Mantel Haenszel|Treatments were compared with stratification defined by InvestigatorGroup. Last-observation-carried-forward imputation was implemented.||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the number of Participants with a ≥ 2-points reduction on the weekly average of the daily 24-hour average pain scale at 12 Weeks.||||0.368
72362329|NCT00385671|144236357|SUPERIORITY_OR_OTHER|||||||0.2||95.0||||P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Mantel Haenszel|Treatments were compared with stratification defined by InvestigatorGroup. Last-observation-carried-forward imputation was implemented.||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the number of Participants with a ≥ 2-points reduction on the weekly average of the daily 24-hour average pain scale at 12 Weeks.||||0.200
72362330|NCT00385671|144236358|SUPERIORITY_OR_OTHER|||||||0.572||95.0||||P-value is for GTS. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in LSEQ GTS scores.||||0.572
72362331|NCT00385671|144236358|SUPERIORITY_OR_OTHER|||||||0.345||95.0||||P-value is for GTS. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 weeks in LSEQ GTS scores.||||0.345
72362332|NCT00385671|144236358|SUPERIORITY_OR_OTHER|||||||0.699||95.0||||P-value is for GTS. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in LSEQ GTS scores.||||0.699
72362333|NCT00385671|144236358|SUPERIORITY_OR_OTHER|||||||0.954||95.0||||P-value is for QOS. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in LSEQ QOS scores.||||0.954
72362334|NCT00385671|144236358|SUPERIORITY_OR_OTHER|||||||0.734||95.0||||P-value is for QOS. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in LSEQ QOS scores.||||0.734
72362335|NCT00385671|144236358|SUPERIORITY_OR_OTHER|||||||0.693||95.0||||P-value is for QOS. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in LSEQ QOS.||||0.693
72362336|NCT00385671|144236358|SUPERIORITY_OR_OTHER|||||||0.72||95.0||||P-value is for AFS. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in LSEQ AFS scores.||||0.720
72362337|NCT00385671|144236358|SUPERIORITY_OR_OTHER|||||||0.722||95.0||||P-value is for AFS. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in LSEQ AFS scores.||||0.722
72362338|NCT00385671|144236358|SUPERIORITY_OR_OTHER|||||||0.48||95.0||||P-value is for AFS. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in LSEQ AFS scores.||||0.480
72362339|NCT00385671|144236358|SUPERIORITY_OR_OTHER|||||||0.498||95.0||||P-value is for BFW. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in LSEQ BFW scores.||||0.498
72362340|NCT00385671|144236358|SUPERIORITY_OR_OTHER|||||||0.865||95.0||||P-value is for BFW. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in LSEQ BFW scores.||||0.865
72368457|NCT00439517|144247114|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.977||||0.8575|TWO_SIDED|95.0|0.755|1.263|||Stratified log rank||Kaplan-Meier method was used to estimate median OS time. HR was calculated using Cox proportional hazards model stratified by randomization strata.|||1.263|0.755|0.8575
72362341|NCT00385671|144236358|SUPERIORITY_OR_OTHER|||||||0.408||95.0||||P-value is for BFW. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in LSEQ BFW scores.||||0.408
72362342|NCT00385671|144236359|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.42||||0.635|TWO_SIDED|95.0|-2.18|1.33||P-value is for total. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in SDS total score.||1.33|-2.18|0.635
72362343|NCT00385671|144236359|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.5||||0.092|TWO_SIDED|95.0|-3.24|0.24||P-value is for total. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in SDS total score.||0.24|-3.24|0.092
72362344|NCT00385671|144236359|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.07||||0.221|TWO_SIDED|95.0|-2.8|0.65||P-value is for total. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in SDS total score.||0.65|-2.80|0.221
72362345|NCT00385671|144236359|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01||||0.974|TWO_SIDED|95.0|-0.88|0.85||P-value is for item 1. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in SDS Item 1 score.||0.85|-0.88|0.974
72362346|NCT00385671|144236359|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.75||||0.093|TWO_SIDED|95.0|-1.63|0.13||P-value is for Item 1. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in SDS Item 1 score.||0.13|-1.63|0.093
72362347|NCT00385671|144236359|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.74||||0.091|TWO_SIDED|95.0|-1.59|0.12||P-value is for item 1. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in SDS Item 1 score.||0.12|-1.59|0.091
72362348|NCT00385671|144236359|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.11||||0.733|TWO_SIDED|95.0|-0.75|0.52||P-value is for item 2. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in SDS Item 2 score.||0.52|-0.75|0.733
72362349|NCT00385671|144236359|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.52||||0.102|TWO_SIDED|95.0|-1.15|0.11||P-value is for item 2. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in SDS item 2 score.||0.11|-1.15|0.102
72362350|NCT00385671|144236359|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.41||||0.193|TWO_SIDED|95.0|-1.04|0.21||P-value is for item 2. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in SDS item 2 score.||0.21|-1.04|0.193
72368458|NCT02304367|144247122|OTHER|||||||0.0428|||||||t-test|||The null hypothesis that the mean change from Baseline to Week 48 in osteoid thickness is zero was tested using a t-test.||||0.0428
72368459|NCT02304367|144247123|OTHER|||||||0.977|||||||t-test|||The null hypothesis that the mean change from Baseline to Week 48 in OS/BS is zero was tested using a t-test.||||0.9770
72368460|NCT02304367|144247124|OTHER|||||||0.0858|||||||t-test|||The null hypothesis that the mean change from Baseline to Week 48 in OV/BV is zero was tested using a t-test.||||0.0858
72368461|NCT02304367|144247125|OTHER|||||||0.4077|||||||t-test|||The null hypothesis that the mean change from Baseline to Week 48 in Mlt is zero was tested using a t-test.||||0.4077
72368462|NCT02304367|144247132|OTHER|||||||0.016|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline 1,25(OH)2D.||Week 24||||0.016
72368463|NCT02304367|144247132|OTHER|||||||0.03|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline 1,25(OH)2D.||Week 48||||0.030
72362351|NCT00385671|144236359|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.17||||0.584|TWO_SIDED|95.0|-0.76|0.43||P-value is for item 3. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in SDS item 3 score.||0.43|-0.76|0.584
72362352|NCT00385671|144236359|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.53||||0.077|TWO_SIDED|95.0|-1.12|0.06||P-value is for item 3. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in SDS item 3 score.||0.06|-1.12|0.077
72362353|NCT00385671|144236359|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.37||||0.221|TWO_SIDED|95.0|-0.95|0.22||P-value is for item 3. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in SDS item 3 score.||0.22|-0.95|0.221
72362354|NCT00385671|144236361|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.82||||0.096|TWO_SIDED|95.0|-3.96|0.32||P-value is for male, total. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in male participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) total score.||0.32|-3.96|0.096
72362355|NCT00385671|144236361|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.01||||0.353|TWO_SIDED|95.0|-3.16|1.13||P-value is for male, total. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in male participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) total score.||1.13|-3.16|0.353
72362356|NCT00385671|144236361|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.81||||0.444|TWO_SIDED|95.0|-1.27|2.88||P-value is for male, total. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in male participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) total score.||2.88|-1.27|0.444
72362357|NCT00385671|144236361|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.6||||0.682|TWO_SIDED|95.0|-2.29|3.48||P-value is for female, total. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in female participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) total score.||3.48|-2.29|0.682
72362358|NCT00385671|144236361|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.13||||0.45|TWO_SIDED|95.0|-4.08|1.82||P-value is for female, total. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in female participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) total score.||1.82|-4.08|0.450
72362359|NCT00385671|144236361|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.73||||0.218|TWO_SIDED|95.0|-4.49|1.04||P-value is for female, total. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in female participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) total score.||1.04|-4.49|0.218
72362360|NCT00385671|144236361|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.05||||0.747|TWO_SIDED|95.0|-0.36|0.26||P-value is for male, pleasure. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in male participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) pleasure subscore.||0.26|-0.36|0.747
72362361|NCT00385671|144236361|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.14||||0.39|TWO_SIDED|95.0|-0.18|0.45||P-value is for male, pleasure. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in male participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) pleasure subscore.||0.45|-0.18|0.390
72362362|NCT00385671|144236361|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.19||||0.228|TWO_SIDED|95.0|-0.12|0.49||P-value is for male, pleasure. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in male participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) pleasure subscore.||0.49|-0.12|0.228
72362363|NCT00385671|144236361|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.24||||0.26|TWO_SIDED|95.0|-0.18|0.67||P-value is for female, pleasure. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in female participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) pleasure subscore.||0.67|-0.18|0.260
72362364|NCT00385671|144236361|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.33||||0.141|TWO_SIDED|95.0|-0.76|0.11||P-value is for female, pleasure. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in female participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) pleasure subscore.||0.11|-0.76|0.141
72362365|NCT00385671|144236361|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.57||||0.007|TWO_SIDED|95.0|-0.98|-0.16||P-value is for female, pleasure. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in female participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) pleasure subscore.||-0.16|-0.98|0.007
72362366|NCT00385671|144236361|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.18||||0.409|TWO_SIDED|95.0|-0.61|0.25||P-value is for male, desire/frequency. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in male participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) desire/frequency subscore.||0.25|-0.61|0.409
72362367|NCT00385671|144236361|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.08||||0.715|TWO_SIDED|95.0|-0.51|0.35||P-value is for male, desire/frequency. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in male participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) desire/frequency subscore.||0.35|-0.51|0.715
72362368|NCT00385671|144236361|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||0.641|TWO_SIDED|95.0|-0.32|0.52||P-value is for male, desire/frequency. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in male participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) desire/frequency subscore.||0.52|-0.32|0.641
72362369|NCT00385671|144236361|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.08||||0.767|TWO_SIDED|95.0|-0.64|0.47||P-value is for female, desire/frequency. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in female participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) desire/frequency subscore.||0.47|-0.64|0.767
72362370|NCT00385671|144236361|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.04||||0.881|TWO_SIDED|95.0|-0.61|0.52||P-value is for female, desire/frequency. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in female participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) desire/frequency subscore.||0.52|-0.61|0.881
72362371|NCT00385671|144236361|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.04||||0.885|TWO_SIDED|95.0|-0.51|0.59||p-value is for female, desire/frequency. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in female participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) desire/frequency subscore.||0.59|-0.51|0.885
72368464|NCT02304367|144247132|OTHER|||||||0.259|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline 1,25(OH)2D.||Week 96||||0.259
72368465|NCT02304367|144247132|OTHER|||||||0.346|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline 1,25(OH)2D.||Week 144||||0.346
72362372|NCT00385671|144236361|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.32||||0.325|TWO_SIDED|95.0|-0.96|0.32||P-value is for male, desire/interest. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in male participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) desire/interest subscore.||0.32|-0.96|0.325
72362373|NCT00385671|144236361|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.08||||0.798|TWO_SIDED|95.0|-0.73|0.56||P-value is for male, desire/interest. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in male participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) desire/interest subscore.||0.56|-0.73|0.798
72362374|NCT00385671|144236361|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.24||||0.461|TWO_SIDED|95.0|-0.39|0.87||p-value is for male, desire/interest. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in male participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) desire/interest subscore.||0.87|-0.39|0.461
72362375|NCT00385671|144236361|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.18||||0.67|TWO_SIDED|95.0|-1.02|0.66||p-value is for female, desire/interest. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in female participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) desire/interest subscore.||0.66|-1.02|0.670
72362376|NCT00385671|144236361|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.51||||0.243|TWO_SIDED|95.0|-1.37|0.35||P-value is for female, desire/interest. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in female participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) desire/interest subscore.||0.35|-1.37|0.243
72362377|NCT00385671|144236361|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.33||||0.423|TWO_SIDED|95.0|-1.14|0.48||P-value is for female, desire/interest. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in male participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) desire/interest subscore.||0.48|-1.14|0.423
72362378|NCT00385671|144236361|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.34||||0.333|TWO_SIDED|95.0|-1.04|0.35||P-value is for male, arousal. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in male participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) arousal subscore.||0.35|-1.04|0.333
72362379|NCT00385671|144236361|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.35||||0.334|TWO_SIDED|95.0|-1.05|0.36||P-value is for male, arousal. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in male participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) arousal subscore.||0.36|-1.05|0.334
72362380|NCT00385671|144236361|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.99|TWO_SIDED|95.0|-0.69|0.68||P-value is for male, arousal. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in male participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) arousal subscore.||0.68|-0.69|0.990
72362381|NCT00385671|144236361|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2||||0.665|TWO_SIDED|95.0|-0.7|1.09||P-value is for female, arousal. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in female participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) arousal subscore.||1.09|-0.70|0.665
72368466|NCT02304367|144247132|OTHER|||||||0.213|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline 1,25(OH)2D.||Week 168||||0.213
72368467|NCT02304367|144247132|OTHER|||||||0.873|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline 1,25(OH)2D.||Week 192||||0.873
72362382|NCT00385671|144236361|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.18||||0.7|TWO_SIDED|95.0|-1.1|0.74||P-value is for female, arousal. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in female participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) arousal subscore.||0.74|-1.10|0.700
72362383|NCT00385671|144236361|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.38||||0.386|TWO_SIDED|95.0|-1.23|0.48||P-value is for female, arousal. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in female participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) arousal subscore.||0.48|-1.23|0.386
72362384|NCT00385671|144236361|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.56||||0.12|TWO_SIDED|95.0|-1.27|0.15||P-value is for male, orgasm. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in male participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) orgasm subscore.||0.15|-1.27|0.120
72362385|NCT00385671|144236361|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.57||||0.119|TWO_SIDED|95.0|-1.29|0.15||P-value is for male, orgasm. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in male participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) orgasm subscore.||0.15|-1.29|0.119
72362386|NCT00385671|144236361|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01||||0.976|TWO_SIDED|95.0|-0.71|0.69||P-value is for male, arousal. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in male participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) orgasm subscore.||0.69|-0.71|0.976
72362387|NCT00385671|144236361|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.17||||0.026|TWO_SIDED|95.0|0.14|2.2||P-value is for female, orgasm. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in female participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) orgasm subscore.||2.20|0.14|0.026
72362388|NCT00385671|144236361|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.36||||0.497|TWO_SIDED|95.0|-0.69|1.42||P-value is for female, orgasm. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in female participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) orgasm subscore.||1.42|-0.69|0.497
72362389|NCT00385671|144236361|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8||||0.112|TWO_SIDED|95.0|-1.8|0.19||P-value is for female, orgasm. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in female participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) orgasm subscore.||0.19|-1.80|0.112
72362390|NCT00385671|144236362|SUPERIORITY_OR_OTHER|||||||0.486||95.0||||P-value is for male, total. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the number of male participants with a categorical change in total score from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).||||0.486
72362391|NCT00385671|144236362|SUPERIORITY_OR_OTHER|||||||0.983||95.0||||P-value is for male, total. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the number of male participants with a categorical change in total score from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).||||0.983
72362392|NCT00385671|144236362|SUPERIORITY_OR_OTHER|||||||0.411||95.0||||p-value is for male, total. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the number of male participants with a categorical change in total score from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).||||0.411
72362393|NCT00385671|144236362|SUPERIORITY_OR_OTHER|||||||0.554||95.0||||p-value is for female, total. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the number of female participants with a categorical change in total score from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).||||0.554
72362394|NCT00385671|144236362|SUPERIORITY_OR_OTHER|||||||0.128||95.0||||p-value is for female, total. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the number of female participants with a categorical change in total score from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).||||0.128
72362395|NCT00385671|144236362|SUPERIORITY_OR_OTHER|||||||0.488||95.0||||p-value is for female, total. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the number of female participants with a categorical change in total score from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).||||0.488
72362396|NCT00385671|144236362|SUPERIORITY_OR_OTHER|||||||0.226||95.0||||p-value is for male, pleasure. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the number of male participants with a categorical change in pleasure subscore from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).||||0.226
72362397|NCT00385671|144236362|SUPERIORITY_OR_OTHER|||||||0.71||95.0||||p-value is for male, pleasure. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the number of male participants with a categorical change in pleasure subscore from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).||||0.710
72362398|NCT00385671|144236362|SUPERIORITY_OR_OTHER|||||||0.133||95.0||||p-value is for male, pleasure. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the number of male participants with a categorical change in pleasure subscore from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).||||0.133
72362399|NCT00385671|144236362|SUPERIORITY_OR_OTHER|||||||0.257||95.0||||p-value is for female, pleasure. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the number of female participants with a categorical change in pleasure subscore from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).||||0.257
72362400|NCT00385671|144236362|SUPERIORITY_OR_OTHER|||||||0.412||95.0||||p-value is for female, pleasure. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the number of female participants with a categorical change in pleasure subscore from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).||||0.412
72362401|NCT00385671|144236362|SUPERIORITY_OR_OTHER|||||||0.03||95.0||||p-value is for female, pleasure. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the number of female participants with a categorical change in pleasure subscore from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).||||0.030
72362402|NCT00385671|144236362|SUPERIORITY_OR_OTHER|||||||0.024||95.0||||p-value is for male, desire/frequency. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the number of male participants with a categorical change in desire/frequency subscore from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).||||0.024
72362403|NCT00385671|144236362|SUPERIORITY_OR_OTHER|||||||0.25||95.0||||p-value is for male, desire/frequency. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the number of male participants with a categorical change in desire/frequency subscore from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).||||0.250
72362404|NCT00385671|144236362|SUPERIORITY_OR_OTHER|||||||0.489||95.0||||p-value is for male, desire/frequency. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the number of male participants with a categorical change in desire/frequency subscore from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).||||0.489
72368468|NCT02304367|144247132|OTHER|||||||0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline 1,25(OH)2D.||Week 216||||0.001
72362405|NCT00385671|144236362|SUPERIORITY_OR_OTHER|||||||0.682||95.0||||p-value is for female, desire/frequency. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the number of female participants with a categorical change in desire/frequency subscore from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).||||0.682
72362406|NCT00385671|144236362|SUPERIORITY_OR_OTHER|||||||0.953||95.0||||p-value is for female, desire/frequency. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the number of female participants with a categorical change in desire/frequency subscore from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).||||0.953
72362407|NCT00385671|144236362|SUPERIORITY_OR_OTHER|||||||0.803||95.0||||p-value is for female, desire/frequency. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the number of female participants with a categorical change in desire/frequency subscore from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).||||0.803
72362408|NCT00385671|144236362|SUPERIORITY_OR_OTHER|||||||0.694||95.0||||p-value is for male, desire/interest. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the number of male participants with a categorical change in desire/interest subscore from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).||||0.694
72362409|NCT00385671|144236362|SUPERIORITY_OR_OTHER|||||||0.835||95.0||||p-value is for male, desire/interest. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the number of male participants with a categorical change in desire/interest subscore from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).||||0.835
72362410|NCT00385671|144236362|SUPERIORITY_OR_OTHER|||||||0.435||95.0||||p-value is for male, desire/interest. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the number of male participants with a categorical change in desire/interest subscore from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).||||0.435
72362411|NCT00385671|144236362|SUPERIORITY_OR_OTHER|||||||0.379||95.0||||p-value is for female, desire/interest. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the number of female participants with a categorical change in desire/interest subscore from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).||||0.379
72362412|NCT00385671|144236362|SUPERIORITY_OR_OTHER|||||||0.247||95.0||||p-value is for female, desire/interest. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the number of female participants with a categorical change in desire/interest subscore from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).||||0.247
72362413|NCT00385671|144236362|SUPERIORITY_OR_OTHER|||||||0.784||95.0||||p-value is for female, desire/interest. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the number of female participants with a categorical change in desire/interest subscore from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).||||0.784
72362414|NCT00385671|144236362|SUPERIORITY_OR_OTHER|||||||0.696||95.0||||p-value is for male, arousal. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the number of male participants with a categorical change in arousal subscore from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).||||0.696
72362415|NCT00385671|144236362|SUPERIORITY_OR_OTHER|||||||0.725||95.0||||P-value is for male, arousal. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the number of male participants with a categorical change in arousal subscore from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).||||0.725
72362416|NCT00385671|144236362|SUPERIORITY_OR_OTHER|||||||0.899||95.0||||P-value is for male, arousal. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the number of male participants with a categorical change in arousal subscore from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).||||0.899
72368469|NCT02304367|144247132|OTHER|||||||0.04|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline 1,25(OH)2D.||Week 240||||0.040
72362417|NCT00385671|144236362|SUPERIORITY_OR_OTHER|||||||0.782||95.0||||P-value is for female, arousal. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the number of female participants with a categorical change in arousal subscore from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).||||0.782
72362418|NCT00385671|144236362|SUPERIORITY_OR_OTHER|||||||0.307||95.0||||P-value is for female, arousal. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the number of female participants with a categorical change in arousal subscore from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).||||0.307
72362419|NCT00385671|144236362|SUPERIORITY_OR_OTHER|||||||0.457||95.0||||P-value is for female, arousal. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the number of female participants with a categorical change in arousal subscore from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).||||0.457
72362420|NCT00385671|144236362|SUPERIORITY_OR_OTHER|||||||0.712||95.0||||P-value is for male, orgasm. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the number of male participants with a categorical change in orgasm subscore from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).||||0.712
72362421|NCT00385671|144236362|SUPERIORITY_OR_OTHER|||||||0.403||95.0||||P-value is for male, orgasm. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the number of male participants with a categorical change in orgasm subscore from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).||||0.403
72362422|NCT00385671|144236362|SUPERIORITY_OR_OTHER|||||||0.713||95.0||||P-value is for male, orgasm. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the number of male participants with a categorical change in orgasm subscore from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).||||0.713
72362423|NCT00385671|144236362|SUPERIORITY_OR_OTHER|||||||0.498||95.0||||P-value is for female, orgasm. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the number of female participants with a categorical change in orgasm subscore from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).||||0.498
72362424|NCT00385671|144236362|SUPERIORITY_OR_OTHER|||||||0.963||95.0||||P-value is for female, orgasm. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the number of female participants with a categorical change in orgasm subscore from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).||||0.963
72362425|NCT00385671|144236362|SUPERIORITY_OR_OTHER|||||||0.338||95.0||||P-value is for female, orgasm. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the number of female participants with a categorical change in orgasm subscore from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).||||0.338
72362426|NCT00385671|144236363|SUPERIORITY_OR_OTHER|||||||0.645||95.0||||P-value is for total. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in Portland Neurotoxicity Scale Total Score.||||0.645
72362427|NCT00385671|144236363|SUPERIORITY_OR_OTHER|||||||0.248||95.0||||P-value is for total. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in Portland Neurotoxicity Scale Total Score.||||0.248
72362428|NCT00385671|144236363|SUPERIORITY_OR_OTHER|||||||0.47||95.0||||P-value is for total. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in Portland Neurotoxicity Scale Total Score.||||0.470
72368470|NCT02304367|144247133|OTHER||||||<|0.0001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline total FGF23.||Week 24||||<0.0001
72362429|NCT00385671|144236363|SUPERIORITY_OR_OTHER|||||||0.914||95.0||||P-value is for cognitive toxicity. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in Portland Neurotoxicity Cognitive Toxicity Score.||||0.914
72362430|NCT00385671|144236363|SUPERIORITY_OR_OTHER|||||||0.505||95.0||||P-value is for cognitive toxicity. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in Portland Neurotoxicity Cognitive Toxicity Score.||||0.505
72362431|NCT00385671|144236363|SUPERIORITY_OR_OTHER|||||||0.57||95.0||||P-value is for cognitive toxicity. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in Portland Neurotoxicity Cognitive Toxicity Score.||||0.570
72362432|NCT00385671|144236363|SUPERIORITY_OR_OTHER|||||||0.43||95.0||||P-value is for somatomotor toxicity. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in Portland Neurotoxicity Scale Somatomotor Toxicity Score.||||0.430
72362433|NCT00385671|144236363|SUPERIORITY_OR_OTHER|||||||0.09||95.0||||P-value is for somatomotor toxicity. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in Portland Neurotoxicity Scale Somatomotor Toxicity Score.||||0.090
72362434|NCT00385671|144236363|SUPERIORITY_OR_OTHER|||||||0.341||95.0||||P-value is for somatomotor toxicity. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in Portland Neurotoxicity Scale Somatomotor Toxicity Score.||||0.341
72362435|NCT00385671|144236364|SUPERIORITY_OR_OTHER|||||||0.13||95.0||||P-value is for total. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the number of participants with a categorial change from baseline to 12 weeks in the Portland Neurotoxicity Scale total score.||||0.130
72362436|NCT00385671|144236364|SUPERIORITY_OR_OTHER|||||||0.192||95.0||||P-value is for total. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the number of participants with a categorial change from baseline to 12 weeks in the Portland Neurotoxicity Scale total score.||||0.192
72362437|NCT00385671|144236364|SUPERIORITY_OR_OTHER|||||||0.936||95.0||||P-value is for total. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the number of participants with a categorial change from baseline to 12 weeks in the Portland Neurotoxicity Scale total score.||||0.936
72362438|NCT00385671|144236364|SUPERIORITY_OR_OTHER|||||||0.48||95.0||||P-value is for cognitive toxicity. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the number of participants with a categorial change from baseline to 12 weeks in the Portland Neurotoxicity Scale cognitive toxicity score.||||0.480
72362439|NCT00385671|144236364|SUPERIORITY_OR_OTHER|||||||0.69||95.0||||P-value is for cognitive toxicity. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the number of participants with a categorial change from baseline to 12 weeks in the Portland Neurotoxicity Scale cognitive toxicity score.||||0.690
72362440|NCT00385671|144236364|SUPERIORITY_OR_OTHER|||||||0.923||95.0||||P-value is for cognitive toxicity. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the number of participants with a categorial change from baseline to 12 weeks in the Portland Neurotoxicity Scale cognitive toxicity score.||||0.923
72368471|NCT02304367|144247133|OTHER||||||<|0.0001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline total FGF23.||Week 48||||<0.0001
72362441|NCT00385671|144236364|SUPERIORITY_OR_OTHER|||||||0.202||95.0||||P-value is for somatomotor toxicity. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the number of participants with a categorial change from baseline to 12 weeks in the Portland Neurotoxicity Scale somatomotor toxicity score.||||0.202
72362442|NCT00385671|144236364|SUPERIORITY_OR_OTHER|||||||0.114||95.0||||P-value is for somatomotor toxicity. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the number of participants with a categorial change from baseline to 12 weeks in the Portland Neurotoxicity Scale somatomotor toxicity score.||||0.114
72362443|NCT00385671|144236364|SUPERIORITY_OR_OTHER|||||||0.954||95.0||||P-value is for somatomotor toxicity. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the number of participants with a categorial change from baseline to 12 weeks in the Portland Neurotoxicity Scale somatomotor toxicity score.||||0.954
72362444|NCT00385671|144236365|SUPERIORITY_OR_OTHER|||||||0.107||95.0||||P-value for Direct Treatment Effect. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for tests of direct and indirect effects.|Regression, Linear|||||||0.107
72362445|NCT00385671|144236366|SUPERIORITY_OR_OTHER|||||||0.968||95.0||||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in BDI-II total score.||||0.968
72362446|NCT00385671|144236366|SUPERIORITY_OR_OTHER|||||||0.492||95.0||||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in BDI-II total score.||||0.492
72362447|NCT00385671|144236366|SUPERIORITY_OR_OTHER|||||||0.463||95.0||||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in BDI-II total score.||||0.463
72362448|NCT00385671|144236369|SUPERIORITY_OR_OTHER|||||||0.103||95.0||||P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Log Rank|Pairwise p-values come from the log-rank test comparing treatment-specific time-to-event curves constructed using the Kaplan-Meier technique.||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in time to first ≥ 30% reduction in weekly mean 24 hour average pain score.||||0.103
72362449|NCT00385671|144236369|SUPERIORITY_OR_OTHER|||||||0.167||95.0||||P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Log Rank|Pairwise p-values come from the log-rank test comparing treatment-specific time-to-event curves constructed using the Kaplan-Meier technique.||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in time to first ≥ 30% reduction in weekly mean 24 hour average pain score.||||0.167
72362450|NCT00385671|144236369|SUPERIORITY_OR_OTHER|||||||0.919||95.0||||P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Log Rank|Pairwise p-values come from the log-rank test comparing treatment-specific time-to-event curves constructed using the Kaplan-Meier technique.||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in time to first ≥ 30% reduction in weekly mean 24 hour average pain score.||||0.919
72362451|NCT00385671|144236372|SUPERIORITY_OR_OTHER|||||||0.008||95.0||||P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Log Rank|Pairwise p-values come from the log-rank test comparing treatment-specific time-to-event curves constructed using the Kaplan-Meier technique.||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in time to first ≥ 2 points reduction in weekly mean 24 hour average pain score.||||0.008
72362452|NCT00385671|144236372|SUPERIORITY_OR_OTHER|||||||0.033||95.0||||P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Log Rank|Pairwise p-values come from the log-rank test comparing treatment-specific time-to-event curves constructed using the Kaplan-Meier technique.||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in time to first ≥ 2 points reduction in weekly mean 24 hour average pain score.||||0.033
72362453|NCT00385671|144236372|SUPERIORITY_OR_OTHER|||||||0.688||95.0||||P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Log Rank|Pairwise p-values come from the log-rank test comparing treatment-specific time-to-event curves constructed using the Kaplan-Meier technique.||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in time to first ≥ 2 points reduction in weekly mean 24 hour average pain score.||||0.688
72368472|NCT02304367|144247133|OTHER|||||||0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline total FGF23.||Week 96||||0.001
72362454|NCT00385671|144236374|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.28||||0.365|TWO_SIDED|95.0|-0.33|0.9||P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week with participant is as a random effect, Kenward-Roger approximation.||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in Weekly mean change from baseline to 12 weeks in 24 hour average pain severity score when analyzing only treatment-compliant participants.||0.90|-0.33|0.365
72362455|NCT00385671|144236374|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.46||||0.172|TWO_SIDED|95.0|-0.2|1.13||P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week with participant is as a random effect, Kenward-Roger approximation.||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in Weekly mean change from baseline to 12 weeks in 24 hour average pain severity score when analyzing only treatment-compliant participants.||1.13|-0.20|0.172
72362456|NCT00385671|144236374|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.18||||0.594|TWO_SIDED|95.0|-0.49|0.85||P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week with participant is as a random effect, Kenward-Roger approximation.||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in Weekly mean change from baseline to 12 weeks in 24 hour average pain severity score when analyzing only treatment-compliant participants.||0.85|-0.49|0.594
72362457|NCT00385671|144236375|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.16||||0.622|TWO_SIDED|95.0|-0.48|0.8||P-value is for de novo, week 1. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 1.||0.80|-0.48|0.622
72362458|NCT00385671|144236375|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.49||||0.153|TWO_SIDED|95.0|-0.18|1.16||P-value is for de novo, week 1. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 1.||1.16|-0.18|0.153
72362459|NCT00385671|144236375|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.33||||0.344|TWO_SIDED|95.0|-0.35|1.0||P-value is for de novo, week 1. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 1.||1.00|-0.35|0.344
72362460|NCT00385671|144236375|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.71||||0.058|TWO_SIDED|95.0|-0.02|1.45||P-value is for de novo, week 2. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 2.||1.45|-0.02|0.058
72362461|NCT00385671|144236375|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.83||||0.032|TWO_SIDED|95.0|0.07|1.59||P-value is for de novo, week 2. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 2.||1.59|0.07|0.032
72362462|NCT00385671|144236375|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.12||||0.762|TWO_SIDED|95.0|-0.66|0.9||P-value is for de novo, week 2. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 2.||0.90|-0.66|0.762
72368473|NCT02304367|144247133|OTHER|||||||0.007|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline total FGF23.||Week 144||||0.007
72368474|NCT02304367|144247133|OTHER|||||||0.005|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline total FGF23.||Week 168||||0.005
72368475|NCT02304367|144247133|OTHER|||||||0.004|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline total FGF23.||Week 192||||0.004
72362463|NCT00385671|144236375|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.91||||0.029|TWO_SIDED|95.0|0.09|1.73||P-value is for de novo, week 3. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 3.||1.73|0.09|0.029
72362464|NCT00385671|144236375|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.12||||0.01|TWO_SIDED|95.0|0.27|1.97||P-value is for de nove, 3 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 3.||1.97|0.27|0.010
72362465|NCT00385671|144236375|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.21||||0.619|TWO_SIDED|95.0|-0.63|1.06||P-value is for de nove, 3 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 3.||1.06|-0.63|0.619
72362466|NCT00385671|144236375|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.83||||0.058|TWO_SIDED|95.0|-0.03|1.69||P-value is for de novo, 4 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 4.||1.69|-0.03|0.058
72362467|NCT00385671|144236375|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.51||||0.001|TWO_SIDED|95.0|0.61|2.41||P-value is for de novo, 4 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 4.||2.41|0.61|0.001
72362468|NCT00385671|144236375|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.68||||0.142|TWO_SIDED|95.0|-0.23|1.58||P-value is for de nove, 4 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 1.||1.58|-0.23|0.142
72362469|NCT00385671|144236375|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.85||||0.065|TWO_SIDED|95.0|-0.05|1.76||P-value is for de novo, 5 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 5.||1.76|-0.05|0.065
72362470|NCT00385671|144236375|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.7|||<|0.001|TWO_SIDED|95.0|0.75|2.65||P-value is for de novo, 5 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 5.||2.65|0.75|<0.001
72362471|NCT00385671|144236375|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.85||||0.079|TWO_SIDED|95.0|-0.1|1.79||P-value is for de novo, 5 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 5.||1.79|-0.10|0.079
72362472|NCT00385671|144236375|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.79||||0.093|TWO_SIDED|95.0|-0.13|1.71||P-value is for de novo, 6 week. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 6.||1.71|-0.13|0.093
72362473|NCT00385671|144236375|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.56||||0.002|TWO_SIDED|95.0|0.59|2.53||P-value is for de novo, 6 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 6.||2.53|0.59|0.002
72362474|NCT00385671|144236375|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.77||||0.119|TWO_SIDED|95.0|-0.2|1.74||P-value is for de novo, 6 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 6.||1.74|-0.20|0.119
72362475|NCT00385671|144236375|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.98||||0.036|TWO_SIDED|95.0|0.06|1.91||P-value is for de novo, 7 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 7.||1.91|0.06|0.036
72362476|NCT00385671|144236375|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.65|||<|0.001|TWO_SIDED|95.0|0.68|2.61||P-value is for de novo, 7 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 7.||2.61|0.68|<0.001
72362477|NCT00385671|144236375|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.66||||0.178|TWO_SIDED|95.0|-0.3|1.63||P-value is for de novo, 7 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 7.||1.63|-0.30|0.178
72362478|NCT00385671|144236375|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.81||||0.093|TWO_SIDED|95.0|-0.14|1.75||P-value is for de novo, 8 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 8.||1.75|-0.14|0.093
72362479|NCT00385671|144236375|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.52||||0.003|TWO_SIDED|95.0|0.53|2.51||P-value is for de novo, 8 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 7.||2.51|0.53|0.003
72362480|NCT00385671|144236375|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.72||||0.157|TWO_SIDED|95.0|-0.28|1.71||P-value is for de novo, 8 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 1.||1.71|-0.28|0.157
72362481|NCT00385671|144236375|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.89||||0.063|TWO_SIDED|95.0|-0.05|1.82||P-value is for de novo, 9 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 9.||1.82|-0.05|0.063
72362482|NCT00385671|144236375|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.68|||<|0.001|TWO_SIDED|95.0|0.7|2.66||P-value is for de novo, 9 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 9.||2.66|0.70|<0.001
72362483|NCT00385671|144236375|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.79||||0.114|TWO_SIDED|95.0|-0.19|1.77||P-value is for de novo, 9 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 9.||1.77|-0.19|0.114
72362484|NCT00385671|144236375|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.51||||0.295|TWO_SIDED|95.0|-0.44|1.46||P-value is for de novo, 10 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 10.||1.46|-0.44|0.295
72362485|NCT00385671|144236375|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.44||||0.005|TWO_SIDED|95.0|0.45|2.44||P-value is for de novo, 10 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 10.||2.44|0.45|0.005
72362486|NCT00385671|144236375|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.94||||0.066|TWO_SIDED|95.0|-0.06|1.94||P-value is for de novo, 10 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 10.||1.94|-0.06|0.066
72362487|NCT00385671|144236375|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.62||||0.208|TWO_SIDED|95.0|-0.35|1.58||P-value is for de novo, 11 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 11.||1.58|-0.35|0.208
72362488|NCT00385671|144236375|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.5||||0.004|TWO_SIDED|95.0|0.49|2.51||P-value is for de novo, 11 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 11.||2.51|0.49|0.004
72362489|NCT00385671|144236375|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.88||||0.086|TWO_SIDED|95.0|-0.13|1.89||P-value is for de novo, 11 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 11.||1.89|-0.13|0.086
72362490|NCT00385671|144236375|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.48||||0.328|TWO_SIDED|95.0|-0.49|1.45||P-value is for de novo, 12 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 12.||1.45|-0.49|0.328
72362491|NCT00385671|144236375|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.46||||0.005|TWO_SIDED|95.0|0.44|2.47||P-value is for de novo, 12 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 12.||2.47|0.44|0.005
72362492|NCT00385671|144236375|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.98||||0.059|TWO_SIDED|95.0|-0.04|1.99||P-value is for de novo, 12 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 12.||1.99|-0.04|0.059
72368476|NCT02304367|144247133|OTHER|||||||0.002|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline total FGF23.||Week 216||||0.002
72368477|NCT02304367|144247133|OTHER|||||||0.006|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline total FGF23.||Week 240||||0.006
72368478|NCT02304367|144247134|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline free FGF23.||Week 24||||< 0.001
72362493|NCT00385671|144236375|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.35||||0.117|TWO_SIDED|95.0|-0.09|0.79||P-value is for prior use, 1 week. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 1.||0.79|-0.09|0.117
72362494|NCT00385671|144236375|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.18||||0.412|TWO_SIDED|95.0|-0.25|0.62||P-value is for prior use, 1 week. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 1.||0.62|-0.25|0.412
72362495|NCT00385671|144236375|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.17||||0.445|TWO_SIDED|95.0|-0.6|0.26||P-value is for prior use, 1 week. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 1.||0.26|-0.60|0.445
72362496|NCT00385671|144236375|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.58||||0.025|TWO_SIDED|95.0|0.07|1.09||P-value is for prior use, 2 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 2.||1.09|0.07|0.025
72362497|NCT00385671|144236375|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.29||||0.257|TWO_SIDED|95.0|-0.21|0.79||P-value is for prior use, 2 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 2.||0.79|-0.21|0.257
72362498|NCT00385671|144236375|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.29||||0.257|TWO_SIDED|95.0|-0.79|0.21||P-value is for prior use, 2 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 2.||0.21|-0.79|0.257
72362499|NCT00385671|144236375|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.5||||0.075|TWO_SIDED|95.0|-0.05|1.04||P-value is for prior use, 3 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 3.||1.04|-0.05|0.075
72362500|NCT00385671|144236375|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.13||||0.634|TWO_SIDED|95.0|-0.42|0.68||P-value is for prior use, 3 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 3.||0.68|-0.42|0.634
72362501|NCT00385671|144236375|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.36||||0.193|TWO_SIDED|95.0|-0.91|0.19||P-value is for prior use, 3 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 3.||0.19|-0.91|0.193
72362502|NCT00385671|144236375|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.12||||0.688|TWO_SIDED|95.0|-0.46|0.7||P-value is for prior use, 4 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 4.||0.70|-0.46|0.688
72362503|NCT00385671|144236375|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02||||0.944|TWO_SIDED|95.0|-0.6|0.56||P-value is for prior use, 4 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 4.||0.56|-0.60|0.944
72362504|NCT00385671|144236375|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.14||||0.64|TWO_SIDED|95.0|-0.73|0.45||P-value is for prior use, 4 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 4.||0.45|-0.73|0.640
72362505|NCT00385671|144236375|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.24||||0.439|TWO_SIDED|95.0|-0.37|0.84||P-value is for prior use, 5 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 5.||0.84|-0.37|0.439
72362506|NCT00385671|144236375|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.23||||0.461|TWO_SIDED|95.0|-0.38|0.84||P-value is for prior use, 5 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 5.||0.84|-0.38|0.461
72362507|NCT00385671|144236375|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01||||0.976|TWO_SIDED|95.0|-0.62|0.6||P-value is for prior use, 5 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 5.||0.60|-0.62|0.976
72362508|NCT00385671|144236375|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.07||||0.829|TWO_SIDED|95.0|-0.55|0.68||P-value is for prior use, 6 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 6.||0.68|-0.55|0.829
72362509|NCT00385671|144236375|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.12||||0.713|TWO_SIDED|95.0|-0.5|0.74||P-value is for prior use, 6 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 6.||0.74|-0.50|0.713
72362510|NCT00385671|144236375|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.05||||0.878|TWO_SIDED|95.0|-0.58|0.67||P-value is for prior use, 6 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 6.||0.67|-0.58|0.878
72362511|NCT00385671|144236375|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.24||||0.447|TWO_SIDED|95.0|-0.38|0.85||P-value is for prior use, 7 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 7.||0.85|-0.38|0.447
72362512|NCT00385671|144236375|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.21||||0.511|TWO_SIDED|95.0|-0.41|0.83||P-value is for prior use, 7 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 7.||0.83|-0.41|0.511
72362513|NCT00385671|144236375|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.03||||0.924|TWO_SIDED|95.0|-0.65|0.59||P-value is for prior use, 7 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 7.||0.59|-0.65|0.924
72362514|NCT00385671|144236375|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.43||||0.185|TWO_SIDED|95.0|-0.2|1.06||P-value is for prior use, 8 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 8.||1.06|-0.20|0.185
72362515|NCT00385671|144236375|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.27||||0.403|TWO_SIDED|95.0|-0.37|0.91||P-value is for prior use, 8 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 8.||0.91|-0.37|0.403
72362516|NCT00385671|144236375|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.15||||0.636|TWO_SIDED|95.0|-0.79|0.49||P-value is for prior use, 8 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 8.||0.49|-0.79|0.636
72362517|NCT00385671|144236375|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.33||||0.304|TWO_SIDED|95.0|-0.3|0.95||P-value is for prior use, 9 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 9.||0.95|-0.30|0.304
72362518|NCT00385671|144236375|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.34||||0.295|TWO_SIDED|95.0|-0.29|0.97||P-value is for prior use, 9 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 9.||0.97|-0.29|0.295
72362519|NCT00385671|144236375|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01||||0.975|TWO_SIDED|95.0|-0.62|0.64||P-value is for prior use, 9 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 9.||0.64|-0.62|0.975
72362520|NCT00385671|144236375|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3||||0.349|TWO_SIDED|95.0|-0.33|0.93||P-value is for prior use, 10 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 10.||0.93|-0.33|0.349
72362521|NCT00385671|144236375|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3||||0.351|TWO_SIDED|95.0|-0.34|0.94||P-value is for prior use, 10 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 10.||0.94|-0.34|0.351
72362522|NCT00385671|144236375|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.992|TWO_SIDED|95.0|-0.64|0.65||P-value is for prior use, 10 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 10.||0.65|-0.64|0.992
72368479|NCT02304367|144247134|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline free FGF23.||Week 48||||< 0.001
72368480|NCT02304367|144247134|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline free FGF23.||Week 96||||<0.001
72362523|NCT00385671|144236375|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.13||||0.681|TWO_SIDED|95.0|-0.5|0.77||P-value is for prior use, 11 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 11.||0.77|-0.50|0.681
72362524|NCT00385671|144236375|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.19||||0.569|TWO_SIDED|95.0|-0.46|0.83||P-value is for prior use, 11 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 11.||0.83|-0.46|0.569
72362525|NCT00385671|144236375|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.05||||0.871|TWO_SIDED|95.0|-0.6|0.7||P-value is for prior use, 11 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 11.||0.70|-0.60|0.871
72362526|NCT00385671|144236375|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.14||||0.675|TWO_SIDED|95.0|-0.5|0.78||P-value is for prior use, 12 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 12.||0.78|-0.50|0.675
72362527|NCT00385671|144236375|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.07||||0.823|TWO_SIDED|95.0|-0.57|0.72||P-value is for prior use, 12 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 12.||0.72|-0.57|0.823
72362528|NCT00385671|144236375|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.06||||0.85|TWO_SIDED|95.0|-0.72|0.59||P-value is for prior use, 12 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 12.||0.59|-0.72|0.850
72362529|NCT00385671|144236377|SUPERIORITY_OR_OTHER|||||||0.448||95.0||||P-value is for diastolic. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in diastolic blood pressure.||||0.448
72362530|NCT00385671|144236377|SUPERIORITY_OR_OTHER|||||||0.118||95.0||||P-value is for diastolic. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in diastolic blood pressure.||||0.118
72362531|NCT00385671|144236377|SUPERIORITY_OR_OTHER|||||||0.021||95.0||||P-value is for diastolic. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in diastolic blood pressure.||||0.021
72362532|NCT00385671|144236377|SUPERIORITY_OR_OTHER|||||||0.537||95.0||||P-value is for systolic. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in systolic blood pressure.||||0.537
72362533|NCT00385671|144236377|SUPERIORITY_OR_OTHER|||||||0.911||95.0||||P-value is for systolic. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in systolic blood pressure.||||0.911
72368481|NCT02304367|144247134|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline free FGF23.||Week 144||||< 0.001
72362534|NCT00385671|144236377|SUPERIORITY_OR_OTHER|||||||0.627||95.0||||P-value is for systolic. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in systolic blood pressure.||||0.627
72362535|NCT00385671|144236378|SUPERIORITY_OR_OTHER|||||||0.078||95.0||||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in heart rate.||||0.078
72362536|NCT00385671|144236378|SUPERIORITY_OR_OTHER|||||||0.13||95.0||||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in heart rate.||||0.130
72362537|NCT00385671|144236378|SUPERIORITY_OR_OTHER|||||||0.85||95.0||||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in heart rate.||||0.850
72362538|NCT00385671|144236379|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in body weight.||||<0.001
72362539|NCT00385671|144236379|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in body weight.||||<0.001
72362540|NCT00385671|144236379|SUPERIORITY_OR_OTHER|||||||0.011||95.0||||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in body weight.||||0.011
72362541|NCT00385671|144236380|SUPERIORITY_OR_OTHER|||||||0.83||95.0||||P-value is for diastolic. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Fisher Exact|||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in the number of participants with elevated diastolic blood pressure.||||0.830
72362542|NCT00385671|144236380|SUPERIORITY_OR_OTHER|||||||1||95.0||||P-value is for diastolic. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Fisher Exact|||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in the number of participants with elevated diastolic blood pressure.||||1.00
72362543|NCT00385671|144236380|SUPERIORITY_OR_OTHER|||||||1||95.0||||P-value is for diastolic. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Fisher Exact|||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in the number of participants with elevated diastolic blood pressure.||||1.00
72362544|NCT00385671|144236380|SUPERIORITY_OR_OTHER|||||||0.06||95.0||||P-value is for systolic. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Fisher Exact|||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in the number of participants with elevated systolic blood pressure.||||0.060
72362545|NCT00385671|144236380|SUPERIORITY_OR_OTHER|||||||0.502||95.0||||P-value is for systolic. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Fisher Exact|||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in the number of participants with elevated systolic blood pressure.||||0.502
72362546|NCT00385671|144236380|SUPERIORITY_OR_OTHER|||||||0.376||95.0||||P-value is for systolic. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Fisher Exact|||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in the number of participants with elevated systolic blood pressure.||||0.376
72368482|NCT02304367|144247134|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline free FGF23.||Week 168||||< 0.001
72362547|NCT00385671|144236381|SUPERIORITY_OR_OTHER|||||||0.281||95.0||||P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Fisher Exact|||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the number of participants with treatment-emergent elevated heart rate.||||0.281
72362548|NCT00385671|144236381|SUPERIORITY_OR_OTHER|||||||0.06||95.0||||P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Fisher Exact|||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the number of participants with treatment-emergent elevated heart rate.||||0.060
72362549|NCT00385671|144236381|SUPERIORITY_OR_OTHER|||||||0.596||95.0||||P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Fisher Exact|||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the number of participants with treatment-emergent elevated heart rate.||||0.596
72362550|NCT00385671|144236382|SUPERIORITY_OR_OTHER|||||||0.332||95.0||||P-value is for high. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Fisher Exact|||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the number of patients with treatment-emergent high body weight.||||0.332
72362551|NCT00385671|144236382|SUPERIORITY_OR_OTHER|||||||0.065||95.0||||P-value is for high. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Fisher Exact|||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the number of patients with treatment-emergent high body weight.||||0.065
72362552|NCT00385671|144236382|SUPERIORITY_OR_OTHER|||||||0.622||95.0||||P-value is for high. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Fisher Exact|||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the number of patients with treatment-emergent high body weight.||||0.622
72362553|NCT00385671|144236382|SUPERIORITY_OR_OTHER|||||||0.103||95.0||||P-value is for low. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Fisher Exact|||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the number of patients with treatment-emergent low body weight.||||0.103
72362554|NCT00385671|144236382|SUPERIORITY_OR_OTHER|||||||0.034||95.0||||P-value is for low. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Fisher Exact|||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the number of patients with treatment-emergent low body weight.||||0.034
72362555|NCT00385671|144236382|SUPERIORITY_OR_OTHER|||||||0.808||95.0||||P-value is for low. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Fisher Exact|||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the number of patients with treatment-emergent low body weight.||||0.808
72362556|NCT00385671|144236383|SUPERIORITY_OR_OTHER|||||||0.055||95.0||||P-value is for AST. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|Analysis of Variance model \& t-test: Rank-transformed Change=InvestigatorGroup+Treatment. Last-observation-carried-forward imputation was implemented.||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 in AST.||||0.055
72362557|NCT00385671|144236383|SUPERIORITY_OR_OTHER|||||||0.051||95.0||||P-value is for AST. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|Analysis of Variance model \& t-test: Rank-transformed Change=InvestigatorGroup+Treatment. Last-observation-carried-forward imputation was implemented.||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 in AST.||||0.051
72362558|NCT00385671|144236383|SUPERIORITY_OR_OTHER|||||||0.993||95.0||||P-value is for AST. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|Analysis of Variance model \& t-test: Rank-transformed Change=InvestigatorGroup+Treatment. Last-observation-carried-forward imputation was implemented.||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 in AST.||||0.993
72362559|NCT00385671|144236383|SUPERIORITY_OR_OTHER|||||||0.928||95.0||||P-value is for ALT. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|Analysis of Variance model \& t-test: Rank-transformed Change=InvestigatorGroup+Treatment. Last-observation-carried-forward imputation was implemented.||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 in ALT.||||0.928
72362560|NCT00385671|144236383|SUPERIORITY_OR_OTHER|||||||0.609||95.0||||P-value is for ALT. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|Analysis of Variance model \& t-test: Rank-transformed Change=InvestigatorGroup+Treatment. Last-observation-carried-forward imputation was implemented.||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 in ALT.||||0.609
72362561|NCT00385671|144236383|SUPERIORITY_OR_OTHER|||||||0.675||95.0||||P-value is for ALT. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|Analysis of Variance model \& t-test: Rank-transformed Change=InvestigatorGroup+Treatment. Last-observation-carried-forward imputation was implemented.||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 in ALT.||||0.675
72362562|NCT00385671|144236383|SUPERIORITY_OR_OTHER|||||||0.985||95.0||||P-value is for GGT. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|Analysis of Variance model \& t-test: Rank-transformed Change=InvestigatorGroup+Treatment. Last-observation-carried-forward imputation was implemented.||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 in GGT.||||0.985
72362563|NCT00385671|144236383|SUPERIORITY_OR_OTHER|||||||0.847||95.0||||P-value is for GGT. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|Analysis of Variance model \& t-test: Rank-transformed Change=InvestigatorGroup+Treatment. Last-observation-carried-forward imputation was implemented.||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 in GGT.||||0.847
72362564|NCT00385671|144236383|SUPERIORITY_OR_OTHER|||||||0.832||95.0||||P-value is for GGT. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|Analysis of Variance model \& t-test: Rank-transformed Change=InvestigatorGroup+Treatment. Last-observation-carried-forward imputation was implemented.||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 in GGT.||||0.832
72362565|NCT00385671|144236383|SUPERIORITY_OR_OTHER|||||||0.169||95.0||||P-value is for AlkPhos. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|Analysis of Variance model \& t-test: Rank-transformed Change=InvestigatorGroup+Treatment. Last-observation-carried-forward imputation was implemented.||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 in AlkPhos.||||0.169
72362566|NCT00385671|144236383|SUPERIORITY_OR_OTHER|||||||0.91||95.0||||P-value is for AlkPhos. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|Analysis of Variance model \& t-test: Rank-transformed Change=InvestigatorGroup+Treatment. Last-observation-carried-forward imputation was implemented.||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 in AlkPhos.||||0.910
72362567|NCT00385671|144236383|SUPERIORITY_OR_OTHER|||||||0.134||95.0||||P-value is for AlkPhos. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|Analysis of Variance model \& t-test: Rank-transformed Change=InvestigatorGroup+Treatment. Last-observation-carried-forward imputation was implemented.||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 in AlkPhos.||||0.134
72362568|NCT00385671|144236384|SUPERIORITY_OR_OTHER|||||||0.285||95.0||||P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|Analysis of Variance model \& t-test: Rank-transformed Change=InvestigatorGroup+Treatment. Last-observation-carried-forward imputation was implemented.||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 total bilirubin.||||0.285
72362569|NCT00385671|144236384|SUPERIORITY_OR_OTHER|||||||0.505||95.0||||P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|Analysis of Variance model \& t-test: Rank-transformed Change=InvestigatorGroup+Treatment. Last-observation-carried-forward imputation was implemented.||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 in total bilirubin.||||0.505
72362570|NCT00385671|144236384|SUPERIORITY_OR_OTHER|||||||0.679||95.0||||P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|Analysis of Variance model \& t-test: Rank-transformed Change=InvestigatorGroup+Treatment. Last-observation-carried-forward imputation was implemented.||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 in total bilirubin.||||0.679
72362571|NCT00385671|144236385|SUPERIORITY_OR_OTHER|||||||0.047||95.0||||P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|Analysis of Variance model \& t-test: Rank-transformed Change=InvestigatorGroup+Treatment. Last-observation-carried-forward imputation was implemented.||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in fasting blood glucose.||||0.047
72362572|NCT00385671|144236385|SUPERIORITY_OR_OTHER|||||||0.232||95.0||||P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|Analysis of Variance model \& t-test: Rank-transformed Change=InvestigatorGroup+Treatment. Last-observation-carried-forward imputation was implemented.||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in fasting blood glucose.||||0.232
72362573|NCT00385671|144236385|SUPERIORITY_OR_OTHER|||||||0.424||95.0||||P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|Analysis of Variance model \& t-test: Rank-transformed Change=InvestigatorGroup+Treatment. Last-observation-carried-forward imputation was implemented.||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in fasting blood glucose.||||0.424
72362574|NCT00385671|144236386|SUPERIORITY_OR_OTHER|||||||0.298||95.0||||P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|Analysis of Variance model \& t-test: Rank-transformed Change=InvestigatorGroup+Treatment. Last-observation-carried-forward imputation was implemented.||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in hemoglobin A1C.||||0.298
72368483|NCT02304367|144247134|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline free FGF23.||Week 192||||< 0.001
72362575|NCT00385671|144236386|SUPERIORITY_OR_OTHER|||||||0.987||95.0||||P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|Analysis of Variance model \& t-test: Rank-transformed Change=InvestigatorGroup+Treatment. Last-observation-carried-forward imputation was implemented.||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in hemoglobin A1C.||||0.987
72362576|NCT00385671|144236386|SUPERIORITY_OR_OTHER|||||||0.297||95.0||||P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|Analysis of Variance model \& t-test: Rank-transformed Change=InvestigatorGroup+Treatment. Last-observation-carried-forward imputation was implemented.||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in hemoglobin A1C.||||0.297
72362577|NCT00385671|144236387|SUPERIORITY_OR_OTHER|||||||1||95.0||||P-value is for AST. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Fisher Exact|||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the number of participants with treatment-emergent elevated AST values.||||1.00
72362578|NCT00385671|144236387|SUPERIORITY_OR_OTHER|||||||0.749||95.0||||P-value is for AST. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Fisher Exact|||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the number of participants with treatment-emergent elevated AST values.||||0.749
72362579|NCT00385671|144236387|SUPERIORITY_OR_OTHER|||||||0.75||95.0||||P-value is for AST. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Fisher Exact|||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the number of participants with treatment-emergent elevated AST values.||||0.750
72362580|NCT00385671|144236387|SUPERIORITY_OR_OTHER|||||||0.05||95.0||||P-value is for ALT. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Fisher Exact|||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the number of participants with treatment-emergent elevated ALT values.||||0.050
72362581|NCT00385671|144236387|SUPERIORITY_OR_OTHER|||||||0.32||95.0||||P-value is for ALT. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Fisher Exact|||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the number of participants with treatment-emergent elevated ALT values.||||0.320
72362582|NCT00385671|144236387|SUPERIORITY_OR_OTHER|||||||0.44||95.0||||P-value is for ALT. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Fisher Exact|||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the number of participants with treatment-emergent elevated ALT values.||||0.440
72362583|NCT00385671|144236387|SUPERIORITY_OR_OTHER|||||||0.498||95.0||||P-value is for TBili. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Fisher Exact|||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the number of participants with treatment-emergent elevated TBili values.||||0.498
72362584|NCT00385671|144236387|SUPERIORITY_OR_OTHER|||||||0.245||95.0||||P-value is for TBili. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Fisher Exact|||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the number of participants with treatment-emergent elevated TBili values.||||0.245
72362585|NCT00385671|144236387|SUPERIORITY_OR_OTHER|||||||0.16||95.0||||P-value is for GGT. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Fisher Exact|||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the number of participants with treatment-emergent elevated GGT values.||||0.160
72362586|NCT00385671|144236387|SUPERIORITY_OR_OTHER|||||||0.28||95.0||||P-value is for GGT. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Fisher Exact|||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the number of participants with treatment-emergent elevated GGT values.||||0.280
72362587|NCT00385671|144236387|SUPERIORITY_OR_OTHER|||||||1||95.0||||P-value is for GGT. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Fisher Exact|||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the number of participants with treatment-emergent elevated GGT values.||||1.00
72362588|NCT00385671|144236387|SUPERIORITY_OR_OTHER|||||||0.023||95.0||||P-value is for FPG. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Fisher Exact|||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the number of participants with treatment-emergent elevated FPG values.||||0.023
72362589|NCT00385671|144236387|SUPERIORITY_OR_OTHER|||||||0.264||95.0||||P-value is for FPG. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Fisher Exact|||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the number of participants with treatment-emergent elevated FPG values.||||0.264
72362590|NCT00385671|144236387|SUPERIORITY_OR_OTHER|||||||0.325||95.0||||P-value is for FPG. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Fisher Exact|||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the number of participants with treatment-emergent elevated FPG values.||||0.325
72362591|NCT00385671|144236387|SUPERIORITY_OR_OTHER|||||||1||95.0||||P-value is for HbA1C. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Fisher Exact|||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the number of participants with treatment-emergent elevated HbA1C values.||||1.00
72362592|NCT00385671|144236387|SUPERIORITY_OR_OTHER|||||||0.121||95.0||||P-value is for HbA1C. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Fisher Exact|||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the number of participants with treatment-emergent elevated HbA1C values.||||0.121
72362593|NCT00385671|144236387|SUPERIORITY_OR_OTHER|||||||0.095||95.0||||P-value is for HbA1C. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Fisher Exact|||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the number of participants with treatment-emergent elevated HbA1C values.||||0.095
72362594|NCT00385671|144236387|SUPERIORITY_OR_OTHER|||||||1||95.0||||P-value is for AlkPhos. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Fisher Exact|||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the number of participants with treatment-emergent elevated AlkPhos values.||||1.00
72362595|NCT00385671|144236387|SUPERIORITY_OR_OTHER|||||||0.72||95.0||||P-value is for AlkPhos. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Fisher Exact|||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the number of participants with treatment-emergent elevated AlkPhos values.||||0.720
72362596|NCT00385671|144236387|SUPERIORITY_OR_OTHER|||||||0.722||95.0||||P-value is for AlkPhos. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Fisher Exact|||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the number of participants with treatment-emergent elevated AlkPhos values.||||0.722
72429375|NCT04102540|144369726|OTHER|In this model, the null hypothesis was that the odds of having good health at baseline/exposure 1 were exactly equal to the odds of having good health at exposure 3 giving an odds ratio of one for the null hypothesis.|Odds Ratio (OR)|1.12||||0.8609|TWO_SIDED|95.0|0.32|3.93||The p-value was not adjusted for multiple comparisons and the a priori threshold for significance was alpha = 0.05.|Regression, Logistic|This model included random effects for subjects.|This is the estimated odds ratio of having good health at exposure 3 relative to baseline/exposure 1.|"For analysis, we dichotomized participants' responses into the following categories: good vs bad health, where good included participant responses: excellent, very good, good, and bad included the participant responses: more or less and bad."||3.93|0.32|0.8609
72429376|NCT04102540|144369727|OTHER|In this analysis, our null hypothesis was that the median current health status at baseline/exposure 1 was exactly equivalent to the median current health status following exposure 2 to the intervention.|Median Difference (Net)|9.13||||0.0572|TWO_SIDED|95.0|-0.3|18.6||The p-value was not adjusted for multiple comparisons and the a priori threshold for significance was alpha = 0.05.|Quantile Regression|Random intercepts for subjects were included in the model.|This is the difference in median current health status between baseline/exposure 1 and exposure 2.|Statistical analysis of current health status between baseline/exposure 1 and exposure 2 to the intervention.||18.6|-0.3|0.0572
72362597|NCT00248625|144236410|SUPERIORITY_OR_OTHER|||||||0.19|TWO_SIDED||||||Log Rank|||||||0.19
72362598|NCT00248625|144236411|SUPERIORITY_OR_OTHER|||||||0.03|TWO_SIDED||||||Log Rank|||||||0.03
72362599|NCT00248625|144236412|SUPERIORITY_OR_OTHER|||||||0.21|||||||Pepe and Mori test of CIF difference|||||||0.21
72362600|NCT00248625|144236413|SUPERIORITY_OR_OTHER|||||||0.053|TWO_SIDED||||||Kruskal-Wallis|||||||0.053
72362601|NCT00248625|144236414|SUPERIORITY_OR_OTHER|||||||0.29|TWO_SIDED||||||Cochran-Armitage trend|||||||0.29
72362602|NCT00248625|144236415|SUPERIORITY_OR_OTHER|||||||0.74|TWO_SIDED||||||Cochran-Armitage trend|||||||0.74
72362603|NCT00248625|144236416|SUPERIORITY_OR_OTHER|||||||0.54|TWO_SIDED||||||Cochran-Armitage tren|||||||0.54
72362604|NCT00248625|144236417|SUPERIORITY_OR_OTHER|||||||0.86|TWO_SIDED||||||Chi-squared|||||||0.86
72362605|NCT03182374|144236418|SUPERIORITY||||||<|0.0001||||||ITT Population|t-test, 2 sided|||||||<0.0001
72362606|NCT03182374|144236419|SUPERIORITY||||||<|0.0001||||||PP Population|t-test, 2 sided|||||||<0.0001
72362607|NCT03182374|144236420|SUPERIORITY|||||||0.6655||||||PP Population|t-test, 2 sided|||||||0.6655
72362608|NCT03182374|144236421|SUPERIORITY||||||<|0.0001||||||PP Population|t-test, 2 sided|||||||<0.0001
72362609|NCT03182374|144236422|SUPERIORITY||||||<|0.05||||||PP population|t-test, 2 sided|||||||<0.05
72362610|NCT03182374|144236423|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
72362611|NCT03085095|144236424|NON_INFERIORITY|The lower bound of the 95% CI for the difference in the cumulative probability of sustained profound castration rate between the 2 treatment groups was calculated with a noninferiority margin of -10%.|Treatment difference|7.9|||||TWO_SIDED|95.0|4.1|11.8|||||Treatment difference= Relugolix - Leuprolide acetate|Following statistical analysis of the lower bound of the 95% CI ≥ 90% for the relugolix group, secondary statistical analysis of non-inferiority was conducted.||11.8|4.1|
72362612|NCT03085095|144236424|SUPERIORITY|If non-inferiority was demonstrated, superiority could be claimed if the lower bound of the 95% CI for the difference in the cumulative probability of sustained profound castration rate between the 2 treatment groups also excluded 0%. The p value was calculated post hoc.|||||<|0.0001|||||||t-test, 2 sided|Two-sided type I error of 0.05.||Following statistical analysis of the lower bound of the 95% CI ≥ 90% for the relugolix group, secondary statistical analysis of superiority was conducted.||||< 0.0001
72362613|NCT03085095|144236425|SUPERIORITY||||||<|0.0001||||||Statistically significance was met if p-value \< 0.05.|t-test, 2 sided|Two-sided type I error rate of 0.05.||Alpha-protected statistical analysis.||||< 0.0001
72362614|NCT03085095|144236426|SUPERIORITY||||||<|0.0001||||||Statistically significance was met if p-value \< 0.05.|t-test, 2 sided|Two-sided type I error rate of 0.05.||Alpha-protected statistical analysis.||||< 0.0001
72362615|NCT03085095|144236427|SUPERIORITY||||||<|0.0001||||||Statistically significance was met if p-value \< 0.05.|Cochran-Mantel-Haenszel|||Alpha-protected statistical analysis.||||< 0.0001
72362616|NCT03085095|144236428|SUPERIORITY||Treatment difference|77.41|||<|0.0001|TWO_SIDED|95.0|73.98|80.83||Statistically significance was met if p-value \< 0.05.|t-test, 2 sided|Two-sided type I error rate of 0.05.|Treatment difference= Relugolix - Leuprolide acetate|Alpha-protected statistical analysis.||80.83|73.98|< 0.0001
72362617|NCT03085095|144236429|SUPERIORITY||||||<|0.0001||||||Statistically significance was met if p-value \< 0.05.|t-test, 2 sided|Two-sided type I error rate of 0.05.||Alpha-protected statistical analysis.||||< 0.0001
72362618|NCT03085095|144236433|OTHER||Treatment difference|13.0|||||TWO_SIDED|95.0|6.9|19.1|||||Treatment difference= Relugolix - Leuprolide acetate|||19.1|6.9|
72362619|NCT03085095|144236435|OTHER||Treatment difference|-2.9|||||TWO_SIDED|95.0|-7.8|2.0|||||Treatment difference= Relugolix - Leuprolide acetate|||2.0|-7.8|
72362620|NCT00408317|144236451|SUPERIORITY_OR_OTHER||Mean Difference (Net)|34.74|||<|0.0001|||||||Mixed Models Analysis|||P-values are from a semi-parametric mixed model on ranked CFA% values including sequence, period, and treatment group as fixed effects; participant identification (ID) as random effect.||||<0.0001
72362621|NCT00408317|144236452|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|25.68|||<|0.0001|||||||Mixed Models Analysis|||P-values are from a semi-parametric mixed model on ranked CNA% values including sequence, period, and treatment group as fixed effects, and participant ID as random effect.||||<0.0001
72362622|NCT00834977|144236479|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Parametric analysis of variance (ANOVA)on AUC0-t, AUCinf and Cmax; geometric Confidence Intervals for AUC0-t, AUC0-inf and Cmax|Ratio of Least Squares Means|101.08||||||90.0|97.23|105.09|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||105.09|97.23|
72362623|NCT00834977|144236480|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Parametric analysis of variance (ANOVA)on AUC0-t, AUCinf and Cmax; geometric Confidence Intervals for AUC0-t, AUC0-inf and Cmax|Ratio of Least Squares Means|99.38||||||90.0|96.63|102.22|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||102.22|96.63|
72362624|NCT00834977|144236481|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Parametric analysis of variance (ANOVA)on AUC0-t, AUCinf and Cmax; geometric Confidence Intervals for AUC0-t, AUC0-inf and Cmax|Ratio of Least Squares Means|98.48||||||90.0|95.8|101.23|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||101.23|95.80|
72362625|NCT00834977|144236482|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Parametric analysis of variance (ANOVA)on AUC0-t, AUCinf and Cmax; geometric Confidence Intervals for AUC0-t, AUC0-inf and Cmax|Ratio of Least Squares Means|98.72||||||90.0|86.95|112.09|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||112.09|86.95|
72362626|NCT00834977|144236483|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Parametric analysis of variance (ANOVA)on AUC0-t, AUCinf and Cmax; geometric Confidence Intervals for AUC0-t, AUC0-inf and Cmax|Ratio of Least Squares Means|95.69||||||90.0|90.54|101.14|||||Metabolite presented for informational purposes only.|||101.14|90.54|
72362627|NCT00834977|144236484|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Parametric analysis of variance (ANOVA)on AUC0-t, AUCinf and Cmax; geometric Confidence Intervals for AUC0-t, AUC0-inf and Cmax|Slope|99.43||||||90.0|96.48|102.46|||||Metabolite presented for informational purposes only.|||102.46|96.48|
72362628|NCT00834977|144236485|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Parametric analysis of variance (ANOVA)on AUC0-t, AUCinf and Cmax; geometric Confidence Intervals for AUC0-t, AUC0-inf and Cmax|Ratio of Least Squares Means|97.2||||||90.0|92.82|101.78|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||101.78|92.82|
72362629|NCT00834977|144236486|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Parametric analysis of variance (ANOVA)on AUC0-t, AUCinf and Cmax; geometric Confidence Intervals for AUC0-t, AUC0-inf and Cmax|Ratio of Least Squares Means|96.99||||||90.0|92.52|101.68|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||101.68|92.52|
72362630|NCT00834977|144236487|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Parametric analysis of variance (ANOVA)on AUC0-t, AUCinf and Cmax; geometric Confidence Intervals for AUC0-t, AUC0-inf and Cmax|Ratio of Least Squares Means|99.24||||||90.0|96.21|102.35|||||Metabolite presented for informational purposes only.|||102.35|96.21|
72362631|NCT00286468|144236501|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.39|||<|0.001|TWO_SIDED|95.0|-0.59|-0.19||A step-down strategy was used for the primary analysis. First, the 25mg dose was compared to placebo at the 2-sided 0.05 significance level. The 12.5 mg dose was compared to placebo only if the comparison of the 25mg dose to placebo was significant.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for glycosylated hemoglobin as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|Null Hypothesis: No difference between treatment and placebo arms in change from baseline in glycosylated hemoglobin at week 26. Sample size calculated based on normally distributed means. For comparison of either dose vs. placebo (2-sample t-test), study sample size \>=500 subjects had 94% power to detect a treatment difference as small as 0.4% in the supportive per-protocol analysis set assuming SD=0.8%, 2-sided \>0.05 significance level, and \>=80% of subjects meeting per protocol criteria.||-0.19|-0.59|<0.001
72368484|NCT02304367|144247134|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline free FGF23.||Week 216||||< 0.001
72368485|NCT02304367|144247134|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline free FGF23.||Week 240||||< 0.001
72362632|NCT00286468|144236501|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.53|||<|0.001|TWO_SIDED|95.0|-0.73|-0.33||A step-down strategy was used for the primary analysis. First, the 25mg dose was compared to placebo at the 2-sided 0.05 significance level. The 12.5 mg dose was compared to placebo only if the comparison of the 25mg dose to placebo was significant.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|Null Hypothesis: No difference between treatment and placebo arms in change from baseline in glycosylated hemoglobin at week 26. Sample size calculated based on normally distributed means. For comparison of either dose vs. placebo (2-sample t-test), study sample size \>=500 subjects had 94% power to detect a treatment difference as small as 0.4% in the supportive per protocol analysis set assuming SD=0.8%, 2-sided \>0.05 significance level and \>=80% of subjects meeting per-protocol criteria.||-0.33|-0.73|<0.001
72362633|NCT00286468|144236502|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.23|||<|0.001|TWO_SIDED|95.0|-0.33|-0.13||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.13|-0.33|<0.001
72362634|NCT00286468|144236502|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.28|||<|0.001|TWO_SIDED|95.0|-0.38|-0.18||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.18|-0.38|<0.001
72362635|NCT00286468|144236503|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.39|||<|0.001|TWO_SIDED|95.0|-0.53|-0.26||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.26|-0.53|<0.001
72362636|NCT00286468|144236503|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.47|||<|0.001|TWO_SIDED|95.0|-0.61|-0.33||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.33|-0.61|<0.001
72362637|NCT00286468|144236504|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.41|||<|0.001|TWO_SIDED|95.0|-0.57|-0.25||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.25|-0.57|<0.001
72362638|NCT00286468|144236504|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.52|||<|0.001|TWO_SIDED|95.0|-0.68|-0.36||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.36|-0.68|<0.001
72362639|NCT00286468|144236505|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.37|||<|0.001|TWO_SIDED|95.0|-0.54|-0.19||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.19|-0.54|<0.001
72362640|NCT00286468|144236505|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5|||<|0.001|TWO_SIDED|95.0|-0.68|-0.33||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.33|-0.68|<0.001
72362641|NCT00286468|144236506|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.36|||<|0.001|TWO_SIDED|95.0|-0.54|-0.17||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.17|-0.54|<0.001
72362642|NCT00286468|144236506|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.52|||<|0.001|TWO_SIDED|95.0|-0.71|-0.34||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.34|-0.71|<0.001
72362643|NCT00286468|144236507|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.1||||0.006|TWO_SIDED|95.0|-20.8|-3.4||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-3.4|-20.8|0.006
72368486|NCT02304367|144247135|OTHER|||||||0.659|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline 24-hour urinary phosphorus.||Week 24||||0.659
72429377|NCT04102540|144369727|OTHER|In this analysis, our null hypothesis was that the median current health status at baseline/exposure 1 was exactly equivalent to the median current health status following exposure 3 to the intervention.|Median Difference (Net)|13.1||||0.0332|TWO_SIDED|95.0|1.1|25.1||The p-value was not adjusted for multiple comparisons and the a priori threshold for significance was alpha = 0.05.|Quantile Regression|Random intercepts for subjects were included in the model.|This is the difference in median current health status between baseline/exposure 1 and exposure 3.|Statistical analysis of self-efficacy to manage HIV scale score between baseline/exposure 1 and exposure 3 to the intervention.||25.1|1.1|0.0332
72362644|NCT00286468|144236507|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.3|||<|0.001|TWO_SIDED|95.0|-28.0|-10.6||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-10.6|-28.0|<0.001
72362645|NCT00286468|144236508|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.9|||<|0.001|TWO_SIDED|95.0|-22.5|-7.2||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-7.2|-22.5|<0.001
72362646|NCT00286468|144236508|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-20.0|||<|0.001|TWO_SIDED|95.0|-27.7|-12.4||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-12.4|-27.7|<0.001
72362647|NCT00286468|144236509|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.9||||0.01|TWO_SIDED|95.0|-19.3|-2.6||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-2.6|-19.3|0.010
72362648|NCT00286468|144236509|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.4|||<|0.001|TWO_SIDED|95.0|-25.8|-9.1||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-9.1|-25.8|<0.001
72362649|NCT00286468|144236510|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.7|||<|0.001|TWO_SIDED|95.0|-25.2|-8.2||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-8.2|-25.2|<0.001
72362650|NCT00286468|144236510|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.4|||<|0.001|TWO_SIDED|95.0|-23.9|-6.9||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-6.9|-23.9|<0.001
72362651|NCT00286468|144236511|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.1||||0.03|TWO_SIDED|95.0|-19.2|-1.0||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-1.0|-19.2|0.030
72362652|NCT00286468|144236511|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.7||||0.012|TWO_SIDED|95.0|-20.8|-2.5||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-2.5|-20.8|0.012
72362653|NCT00286468|144236512|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.9||||0.701|TWO_SIDED|95.0|-11.6|7.8||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||7.8|-11.6|0.701
72362654|NCT00286468|144236512|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.0||||0.228|TWO_SIDED|95.0|-15.7|3.7||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||3.7|-15.7|0.228
72362655|NCT00286468|144236513|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.0||||0.097|TWO_SIDED|95.0|-19.6|1.6||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||1.6|-19.6|0.097
72362656|NCT00286468|144236513|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.3||||0.014|TWO_SIDED|95.0|-23.9|-2.7||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-2.7|-23.9|0.014
72362657|NCT00286468|144236514|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.8||||0.241|TWO_SIDED|95.0|-18.3|4.6||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||4.6|-18.3|0.241
72362658|NCT00286468|144236514|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.5||||0.072|TWO_SIDED|95.0|-22.0|0.9||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.9|-22.0|0.072
72368487|NCT02304367|144247135|OTHER|||||||0.752|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline 24-hour urinary phosphorus.||Week 48||||0.752
72362659|NCT00286468|144236515|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.775||||0.338|TWO_SIDED|95.0|0.46|1.306||no multiplicity adjustments|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline glyburide dose and baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||1.306|0.460|0.338
72362660|NCT00286468|144236515|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.521||||0.016|TWO_SIDED|95.0|0.306|0.887||no multiplicity adjustments|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline metformin dose and baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||0.887|0.306|0.016
72362661|NCT00286468|144236516|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.374||||0.003|TWO_SIDED|95.0|0.194|0.72||no multiplicity adjustments|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline glyburide dose and baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||0.720|0.194|0.003
72362662|NCT00286468|144236516|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.372||||0.003|TWO_SIDED|95.0|0.193|0.718||no multiplicity adjustments|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline glyburide dose and baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||0.718|0.193|0.003
72362663|NCT00286468|144236517|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3||||0.923|TWO_SIDED|95.0|-6.1|6.7||No multiplicity adjustments.|Regression, Logistic|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||6.7|-6.1|0.923
72362664|NCT00286468|144236517|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.7||||0.259|TWO_SIDED|95.0|-2.7|10.1||No multiplicity adjustments.|Regression, Logistic|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||10.1|-2.7|0.259
72362665|NCT00286468|144236518|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3||||0.916|TWO_SIDED|95.0|-6.6|5.9||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||5.9|-6.6|0.916
72362666|NCT00286468|144236518|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.3||||0.305|TWO_SIDED|95.0|-3.0|9.5||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||9.5|-3.0|0.305
72362667|NCT00286468|144236519|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2||||0.953|TWO_SIDED|95.0|-6.1|5.8||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||5.8|-6.1|0.953
72362668|NCT00286468|144236519|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2||||0.957|TWO_SIDED|95.0|-6.1|5.8||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||5.8|-6.1|0.957
72362669|NCT00286468|144236520|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.4||||0.908|TWO_SIDED|95.0|-5.9|6.6||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||6.6|-5.9|0.908
72362670|NCT00286468|144236520|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.7||||0.826|TWO_SIDED|95.0|-5.6|7.0||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||7.0|-5.6|0.826
72362671|NCT00286468|144236521|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.4||||0.894|TWO_SIDED|95.0|-5.9|6.8||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||6.8|-5.9|0.894
72362672|NCT00286468|144236521|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.5||||0.432|TWO_SIDED|95.0|-3.8|8.9||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||8.9|-3.8|0.432
72362673|NCT00286468|144236522|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.9||||0.548|TWO_SIDED|95.0|-8.1|4.3||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||4.3|-8.1|0.548
72362674|NCT00286468|144236522|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.986|TWO_SIDED|95.0|-6.3|6.2||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||6.2|-6.3|0.986
72362675|NCT00286468|144236523|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.26||||0.415|TWO_SIDED|95.0|-1.78|4.3||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||4.30|-1.78|0.415
72362676|NCT00286468|144236523|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.51||||0.332|TWO_SIDED|95.0|-1.54|4.55||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||4.55|-1.54|0.332
72362677|NCT00286468|144236524|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.19||||0.89|TWO_SIDED|95.0|-2.47|2.85||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||2.85|-2.47|0.890
72362678|NCT00286468|144236524|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.19||||0.38|TWO_SIDED|95.0|-1.48|3.86||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||3.86|-1.48|0.380
72362679|NCT00286468|144236525|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.35||||0.448|TWO_SIDED|95.0|-2.14|4.85||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||4.85|-2.14|0.448
72362680|NCT00286468|144236525|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.02||||0.568|TWO_SIDED|95.0|-2.48|4.52||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||4.52|-2.48|0.568
72362681|NCT00286468|144236526|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.95||||0.077|TWO_SIDED|95.0|-0.32|6.22||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||6.22|-0.32|0.077
72362682|NCT00286468|144236526|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.72||||0.303|TWO_SIDED|95.0|-1.55|4.99||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||4.99|-1.55|0.303
72362683|NCT00286468|144236527|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.25||||0.461|TWO_SIDED|95.0|-2.08|4.57||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||4.57|-2.08|0.461
72362684|NCT00286468|144236527|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.99||||0.559|TWO_SIDED|95.0|-2.34|4.32||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||4.32|-2.34|0.559
72362685|NCT00286468|144236528|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.04||||0.43|TWO_SIDED|95.0|-1.54|3.62||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||3.62|-1.54|0.430
72362686|NCT00286468|144236528|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.03||||0.124|TWO_SIDED|95.0|-0.56|4.61||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||4.61|-0.56|0.124
72362687|NCT00286468|144236529|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.056||||0.011|TWO_SIDED|95.0|-0.099|-0.013||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.013|-0.099|0.011
72362688|NCT00286468|144236529|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.035||||0.116|TWO_SIDED|95.0|-0.078|0.009||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.009|-0.078|0.116
72368488|NCT02304367|144247135|OTHER|||||||0.594|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline 24-hour urinary phosphorus.||Week 96||||0.594
72362689|NCT00286468|144236530|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.044||||0.024|TWO_SIDED|95.0|-0.081|-0.006||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.006|-0.081|0.024
72362690|NCT00286468|144236530|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.037||||0.059|TWO_SIDED|95.0|-0.074|0.001||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.001|-0.074|0.059
72362691|NCT00286468|144236531|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.028||||0.159|TWO_SIDED|95.0|-0.067|0.011||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.011|-0.067|0.159
72362692|NCT00286468|144236531|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.038||||0.055|TWO_SIDED|95.0|-0.077|0.001||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.001|-0.077|0.055
72362693|NCT00286468|144236532|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.039||||0.062|TWO_SIDED|95.0|-0.08|0.002||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.002|-0.080|0.062
72362694|NCT00286468|144236532|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.043||||0.041|TWO_SIDED|95.0|-0.084|-0.002||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.002|-0.084|0.041
72362695|NCT00286468|144236533|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.03||||0.148|TWO_SIDED|95.0|-0.069|0.01||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.010|-0.069|0.148
72362696|NCT00286468|144236533|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.031||||0.135|TWO_SIDED|95.0|-0.071|0.009||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.009|-0.071|0.135
72362697|NCT00286468|144236534|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.026||||0.177|TWO_SIDED|95.0|-0.065|0.012||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.012|-0.065|0.177
72362698|NCT00286468|144236534|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.026||||0.177|TWO_SIDED|95.0|-0.065|0.012||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.012|-0.065|0.177
72362699|NCT00286468|144236535|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.162||||0.324|TWO_SIDED|95.0|-0.161|0.486||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.486|-0.161|0.324
72362700|NCT00286468|144236535|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.176||||0.284|TWO_SIDED|95.0|-0.147|0.5||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.500|-0.147|0.284
72362701|NCT00286468|144236536|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.268||||0.053|TWO_SIDED|95.0|-0.004|0.54||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.540|-0.004|0.053
72362702|NCT00286468|144236536|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.349||||0.012|TWO_SIDED|95.0|0.077|0.621||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.621|0.077|0.012
72362703|NCT00286468|144236537|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.182||||0.196|TWO_SIDED|95.0|-0.094|0.458||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.458|-0.094|0.196
72368489|NCT02304367|144247135|OTHER|||||||0.614|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline 24-hour urinary phosphorus.||Week 144||||0.614
72362704|NCT00286468|144236537|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.226||||0.11|TWO_SIDED|95.0|-0.051|0.502||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.502|-0.051|0.110
72362705|NCT00286468|144236538|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.228||||0.121|TWO_SIDED|95.0|-0.06|0.517||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.517|-0.060|0.121
72362706|NCT00286468|144236538|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.159||||0.28|TWO_SIDED|95.0|-0.13|0.448||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.448|-0.130|0.280
72362707|NCT00286468|144236539|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.015||||0.924|TWO_SIDED|95.0|-0.29|0.32||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.320|-0.290|0.924
72362708|NCT00286468|144236539|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.138||||0.376|TWO_SIDED|95.0|-0.168|0.444||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.444|-0.168|0.376
72362709|NCT00286468|144236540|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.075||||0.642|TWO_SIDED|95.0|-0.242|0.393||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.393|-0.242|0.642
72362710|NCT00286468|144236540|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.063||||0.698|TWO_SIDED|95.0|-0.255|0.381||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.381|-0.255|0.698
72362711|NCT00286468|144236541|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.29||||0.596|TWO_SIDED|95.0|0.503|3.306||no multiplicity adjustments|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline glyburide dose and baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||3.306|0.503|0.596
72362712|NCT00286468|144236541|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.96||||0.148|TWO_SIDED|95.0|0.787|4.885||no multiplicity adjustments|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline glyburide dose and baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||4.885|0.787|0.148
72362713|NCT00286468|144236542|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.925||||0.046|TWO_SIDED|95.0|1.011|3.666||no multiplicity adjustments|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline glyburide dose and baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||3.666|1.011|0.046
72362714|NCT00286468|144236542|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.505||||0.005|TWO_SIDED|95.0|1.313|4.78||no multiplicity adjustments|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline glyburide dose and baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||4.780|1.313|0.005
72362715|NCT00286468|144236543|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.955||||0.025|TWO_SIDED|95.0|1.086|3.519||no multiplicity adjustments|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline glyburide dose and baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||3.519|1.086|0.025
72362716|NCT00286468|144236543|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.707|||<|0.001|TWO_SIDED|95.0|2.012|6.831||no multiplicity adjustments|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline glyburide dose and baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||6.831|2.012|<0.001
72362717|NCT00286468|144236544|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.994|||<|0.001|TWO_SIDED|95.0|1.72|5.213||no multiplicity adjustments|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline glyburide dose and baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||5.213|1.720|<0.001
72362718|NCT00286468|144236544|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.401|||<|0.001|TWO_SIDED|95.0|1.95|5.933||no multiplicity adjustments|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline glyburide dose and baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||5.933|1.950|<0.001
72362719|NCT00286468|144236545|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.776||||0.115|TWO_SIDED|95.0|0.87|3.627||no multiplicity adjustments|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline glyburide dose and baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||3.627|0.870|0.115
72362720|NCT00286468|144236545|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.416|||<|0.001|TWO_SIDED|95.0|1.703|6.851||no multiplicity adjustments|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline glyburide dose and baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||6.851|1.703|<0.001
72362721|NCT00286468|144236546|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.991||||0.986|TWO_SIDED|95.0|0.365|2.689||no multiplicity adjustments|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline glyburide dose and baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||2.689|0.365|0.986
72362722|NCT00286468|144236546|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.05||||0.131|TWO_SIDED|95.0|0.808|5.203||no multiplicity adjustments|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline glyburide dose and baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||5.203|0.808|0.131
72362723|NCT00286468|144236547|SUPERIORITY_OR_OTHER|||||||0.626||95.0||||no multiplicity adjustments|Mantel Haenszel|OR and 95% CI not estimable using logistic regression model. Tested using extended Mantel-Haenszel test.||||||0.626
72362724|NCT00286468|144236547|SUPERIORITY_OR_OTHER|||||||0.178||||||no multiplicity adjustments|Mantel Haenszel|OR and 95% CI not estimable using logistic regression model. Tested using extended Mantel-Haenszel test.||||||0.178
72362725|NCT00286468|144236548|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.74|||<|0.001|TWO_SIDED|95.0|0.32|1.16||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||1.16|0.32|<0.001
72362726|NCT00286468|144236548|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.59||||0.006|TWO_SIDED|95.0|0.17|1.02||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||1.02|0.17|0.006
72362727|NCT00286468|144236549|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.69||||0.006|TWO_SIDED|95.0|0.2|1.18||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||1.18|0.20|0.006
72362728|NCT00286468|144236549|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.52||||0.04|TWO_SIDED|95.0|0.02|1.01||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||1.01|0.02|0.040
72362729|NCT00286468|144236550|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.1|||<|0.001|TWO_SIDED|95.0|0.47|1.73||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||1.73|0.47|<0.001
72362730|NCT00286468|144236550|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.91||||0.005|TWO_SIDED|95.0|0.28|1.55||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||1.55|0.28|0.005
72362731|NCT00286468|144236551|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.8||||0.018|TWO_SIDED|95.0|0.14|1.46||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||1.46|0.14|0.018
72362732|NCT00286468|144236551|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.88||||0.01|TWO_SIDED|95.0|0.21|1.54||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||1.54|0.21|0.010
72362733|NCT02923726|144236552|SUPERIORITY||Hazard Ratio (HR)|0.72||||0.005|TWO_SIDED|95.9|0.57|0.92|||Log Rank||Shock only was the reference group. Confidence interval adjusted for interim analyses.|||0.92|0.57|0.005
72362734|NCT02923726|144236553|SUPERIORITY||Hazard Ratio (HR)|0.92||||0.284|TWO_SIDED|95.0|0.78|1.07|||Log Rank||Shock Only was the reference group.|||1.07|0.78|0.284
72362735|NCT02923726|144236554|SUPERIORITY||Hazard Ratio (HR)|0.73||||0.02|TWO_SIDED|95.0|0.56|0.95|||Log Rank||Shock Only arm is reference group.|||0.95|0.56|0.020
72362736|NCT02923726|144236555|SUPERIORITY||Hazard Ratio (HR)|0.65||||0.033|TWO_SIDED|95.0|0.44|0.97|||Log Rank||Shock Only is the reference group.|||0.97|0.44|0.033
72362737|NCT02923726|144236556|SUPERIORITY||Hazard Ratio (HR)|1.15||||0.184|TWO_SIDED|95.0|0.94|1.41|||Log Rank||Shock Only is the reference group.|||1.41|0.94|0.184
72362738|NCT03324607|144236557|OTHER|||||||0.006|||||||Paired t-test|||||||0.006
72362739|NCT00129402|144236590|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.01||95.0|||||ANOVA|||||||<0.01
72362740|NCT00129402|144236591|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.01||95.0|||||ANOVA|||||||<0.01
72362741|NCT00129402|144236592|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.01||95.0|||||ANOVA|||||||<0.01
72362742|NCT00129402|144236593|SUPERIORITY_OR_OTHER_LEGACY|||||||0.48||95.0|||||non-parametric model|||||||.48
72362743|NCT00129402|144236594|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.01||95.0|||||ANOVA|||||||<0.01
72362744|NCT00129402|144236595|SUPERIORITY_OR_OTHER_LEGACY|||||||0.95||95.0|||||ANOVA|||||||.95
72362745|NCT04218240|144236633|SUPERIORITY|||||||0.05|||||||Chi-squared|1 degree of freedom||A nonparametric (Kruskal-Wallis) comparison of the two groups (p=0.049)||||.05
72362746|NCT04218240|144236634|OTHER|Chi-square analysis||||||0.27|||||||Chi-squared|||hypothesis: more people in active PGB/LFX will complete withdrawal CI = 95% P = 0.5||||0.27
72362747|NCT03253796|144236653|SUPERIORITY||Difference in percentage|50.2|||<|0.001|TWO_SIDED|95.0|34.1|63.6|||Miettinen and Nurminen|Derived based on the stratified Miettinen and Nurminen method with CRP level (\>6 mg/L or ≤ 6 mg/L) as a stratification factor||||63.6|34.1|<0.001
72362748|NCT03253796|144236653|SUPERIORITY||Difference in percentage|34.4|||<|0.001|TWO_SIDED|95.0|17.0|49.7|||Meittinen and Nurminen|Derived based on the stratified Miettinen and Nurminen method with CRP level (\>6 mg/L or ≤ 6 mg/L) as a stratification factor||||49.7|17.0|<0.001
72362749|NCT03253796|144236656|SUPERIORITY||Difference in percentage|9.5|||||TWO_SIDED|95.0|3.3|19.4|||||Derived based on the stratified Miettinen and Nurminen method with CRP level (\>6 mg/L or ≤ 6 mg/L) as a stratification factor|||19.4|3.3|
72362750|NCT03253796|144236656|SUPERIORITY||Difference in percentage|3.2|||||TWO_SIDED|95.0|-2.8|10.9|||||Derived based on the stratified Miettinen and Nurminen method with CRP level (\>6 mg/L or ≤ 6 mg/L) as a stratification factor|||10.9|-2.8|
72362751|NCT03253796|144236658|SUPERIORITY||Difference in percentage|0.0|||||TWO_SIDED|95.0|-5.9|5.8|||||Derived based on the stratified Miettinen and Nurminen method with CRP level (\>6 mg/L or ≤ 6 mg/L) as a stratification factor|||5.8|-5.9|
72362752|NCT03253796|144236658|SUPERIORITY||Difference in percentage|0.0|||||TWO_SIDED|95.0|-5.9|5.8|||||Derived based on the stratified Miettinen and Nurminen method with CRP level (\>6 mg/L or ≤ 6 mg/L) as a stratification factor|||5.8|-5.9|
72362753|NCT03253796|144236660|SUPERIORITY||Difference in percentage|14.7|||||TWO_SIDED|95.0|0.2|29.0|||||Derived based on the stratified Miettinen and Nurminen method with CRP level (\>6 mg/L or ≤ 6 mg/L) as a stratification factor|||29.0|0.2|
72362754|NCT03253796|144236660|SUPERIORITY||Difference in percentage|14.7|||||TWO_SIDED|95.0|0.2|29.1|||||Derived based on the stratified Miettinen and Nurminen method with CRP level (\>6 mg/L or ≤ 6 mg/L) as a stratification factor|||29.1|0.2|
72362755|NCT03253796|144236662|SUPERIORITY||Difference in percentage|24.9|||||TWO_SIDED|95.0|8.5|40.3|||||Derived based on the stratified Miettinen and Nurminen method with CRP level (\>6 mg/L or ≤ 6 mg/L) as a stratification factor|||40.3|8.5|
72362756|NCT03253796|144236662|SUPERIORITY||Difference in percentage|5.9|||||TWO_SIDED|95.0|-9.9|21.3|||||Derived based on the stratified Miettinen and Nurminen method with CRP level (\>6 mg/L or ≤ 6 mg/L) as a stratification factor|||21.3|-9.9|
72362757|NCT03253796|144236664|SUPERIORITY||Difference in percentage|24.4|||||TWO_SIDED|95.0|9.1|39.0|||||Derived based on the stratified Miettinen and Nurminen method with CRP level (\>6 mg/L or ≤ 6 mg/L) as a stratification factor|||39.0|9.1|
72362758|NCT03253796|144236664|SUPERIORITY||Difference in percentage|22.8|||||TWO_SIDED|95.0|7.3|37.7|||||Derived based on the stratified Miettinen and Nurminen method with CRP level (\>6 mg/L or ≤ 6 mg/L) as a stratification factor|||37.7|7.3|
72362759|NCT03253796|144236668|SUPERIORITY||Difference in percentage|32.9|||<|0.001|TWO_SIDED|95.0|19.2|44.5|||Miettinen and Nurminen|Derived based on the stratified Miettinen and Nurminen method with CRP level (\>6 mg/L or ≤ 6 mg/L) as a stratification factor||||44.5|19.2|<0.001
72362760|NCT03253796|144236669|SUPERIORITY||Difference in percentage|15.9||||0.037|TWO_SIDED|95.0|0.9|30.5|||Miettinen and Nurminen|Derived based on the stratified Miettinen and Nurminen method with CRP level (\>6 mg/L or ≤ 6 mg/L) as a stratification factor||||30.5|0.9|0.037
72362761|NCT00528112|144236671|SUPERIORITY_OR_OTHER||failure rate|0.009|||||TWO_SIDED|95.0|0.005|0.017||||||Cumulative failure rate (Kaplan-Meier) at 3 years||0.017|0.005|
72362762|NCT00528112|144236671|SUPERIORITY_OR_OTHER||failure rate|0.01||||||95.0|0.005|0.018||||||Cumulative failure rate (Kaplan-Meier) at 3 years||0.018|0.005|
72362763|NCT00528112|144236693|SUPERIORITY_OR_OTHER||failure rate|0.01445|||||TWO_SIDED|95.0|0.00823|0.02531||||||Cumulative failure rate (Kaplan-Meier) at 5 years||0.02531|0.00823|
72362764|NCT02718898|144236698|SUPERIORITY||Odds Ratio (OR)|33.8|||<|0.001|TWO_SIDED|95.0|12.39|92.23|||Regression, Logistic|||||92.23|12.39|<0.001
72362765|NCT02718898|144236699|SUPERIORITY||Odds Ratio (OR)|102.55|||<|0.001|TWO_SIDED|95.0|22.79|461.43|||Regression, Logistic|||||461.43|22.79|<0.001
72362766|NCT02718898|144236700|SUPERIORITY||Odds Ratio (OR)|16.27|||<|0.001|TWO_SIDED|95.0|5.71|46.4|||Regression, Logistic|||||46.40|5.71|<0.001
72362767|NCT02718898|144236701|SUPERIORITY||Odds Ratio (OR)|13.57|||<|0.001|TWO_SIDED|95.0|4.57|40.29|||Regression, Logistic|||||40.29|4.57|<0.001
72362768|NCT02718898|144236702|SUPERIORITY||Odds Ratio (OR)|9.84|||<|0.001|TWO_SIDED|95.0|3.08|31.4|||Regression, Logistic|||||31.40|3.08|<0.001
72362769|NCT02718898|144236703|SUPERIORITY||Mean Difference (Final Values)|-8.4|STANDARD_ERROR_OF_MEAN|0.86|<|0.001|TWO_SIDED|95.0|-10.1|-6.7|||Mixed Models Analysis|||||-6.7|-10.1|<0.001
72362770|NCT02718898|144236704|SUPERIORITY||Mean Difference (Final Values)|-20.0|STANDARD_ERROR_OF_MEAN|2.15|<|0.001|TWO_SIDED|95.0|-24.3|-15.8|||Mixed Models Analysis|||||-15.8|-24.3|<0.001
72362771|NCT02718898|144236705|SUPERIORITY||Odds Ratio (OR)|13.95|||<|0.001|TWO_SIDED|95.0|6.12|31.8|||Regression, Logistic|||||31.80|6.12|<0.001
72362772|NCT02718898|144236706|SUPERIORITY||Mean Difference (Final Values)|4.506|STANDARD_ERROR_OF_MEAN|1.1339|<|0.001|TWO_SIDED|95.0|2.264|6.748|||ANCOVA|||||6.748|2.264|<0.001
72362773|NCT02718898|144236707|SUPERIORITY||Mean Difference (Final Values)|1.797|STANDARD_ERROR_OF_MEAN|1.0367||0.085|TWO_SIDED|95.0|-0.253|3.847|||ANCOVA|||||3.847|-0.253|0.085
72362774|NCT02718898|144236708|SUPERIORITY||Mean Difference (Final Values)|-28.75|STANDARD_ERROR_OF_MEAN|3.015|<|0.001|TWO_SIDED|95.0|-34.72|-22.78|||Mixed Models Analysis|||Total Score||-22.78|-34.72|<0.001
72362775|NCT02718898|144236708|SUPERIORITY||Mean Difference (Final Values)|-3.81|STANDARD_ERROR_OF_MEAN|0.399|<|0.001|TWO_SIDED|95.0|-4.6|-3.02|||Mixed Models Analysis|||Itch||-3.02|-4.60|<0.001
72362776|NCT02718898|144236708|SUPERIORITY||Mean Difference (Final Values)|-3.5|STANDARD_ERROR_OF_MEAN|0.405|<|0.001|TWO_SIDED|95.0|-4.3|-2.7|||Mixed Models Analysis|||Pain||-2.70|-4.30|<0.001
72362777|NCT02718898|144236708|SUPERIORITY||Mean Difference (Final Values)|-3.85|STANDARD_ERROR_OF_MEAN|0.41|<|0.001|TWO_SIDED|95.0|-4.66|-3.04|||Mixed Models Analysis|||Discomfort||-3.04|-4.66|<0.001
72362778|NCT02718898|144236708|SUPERIORITY||Mean Difference (Final Values)|-3.23|STANDARD_ERROR_OF_MEAN|0.41|<|0.001|TWO_SIDED|95.0|-4.04|-2.42|||Mixed Models Analysis|||Stinging||-2.42|-4.04|<0.001
72362779|NCT02718898|144236708|SUPERIORITY||Mean Difference (Final Values)|-3.2|STANDARD_ERROR_OF_MEAN|0.397|<|0.001|TWO_SIDED|95.0|-3.99|-2.41|||Mixed Models Analysis|||Burning||-2.41|-3.99|<0.001
72362780|NCT02718898|144236708|SUPERIORITY||Mean Difference (Final Values)|-3.81|STANDARD_ERROR_OF_MEAN|0.395|<|0.001|TWO_SIDED|95.0|-4.59|-3.03|||Mixed Models Analysis|||Redness||-3.03|-4.59|<0.001
72362781|NCT02718898|144236708|SUPERIORITY||Mean Difference (Final Values)|-3.78|STANDARD_ERROR_OF_MEAN|0.377|<|0.001|TWO_SIDED|95.0|-4.53|-3.03|||Mixed Models Analysis|||Scaling||-3.03|-4.53|<0.001
72362782|NCT02718898|144236708|SUPERIORITY||Mean Difference (Final Values)|-3.55|STANDARD_ERROR_OF_MEAN|0.385|<|0.001|TWO_SIDED|95.0|-4.31|-2.79|||Mixed Models Analysis|||Cracking||-2.79|-4.31|<0.001
72362783|NCT00894803|144236710|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.15||||0.053|TWO_SIDED|95.0|0.01|1.4|||Regression, Logistic|an exact logistic regression was used due to the number of events|Arm 2 (rt-PA and Eptifibitide) represents the numerator, Arm 1 (rt-PA only) the denominator|||1.40|0.01|0.053
72362784|NCT00894803|144236711|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.74||||0.23|TWO_SIDED|95.0|0.7|4.31|||Regression, Logistic||Arm 2 (rt-PA and Eptifibitide) represents the numerator, Arm 1 (rt-PA only) the denominator|||4.31|0.70|0.23
72362785|NCT00894803|144236711|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.37||||0.53|TWO_SIDED|95.0|0.51|3.71|||Regression, Logistic|adjusting for age, baseline NIHSS score and time to IV rt-PA|Arm 2 (rt-PA and Eptifibitide) represents the numerator, Arm 1 (rt-PA only) the denominator|||3.71|0.51|0.53
72362786|NCT00894803|144236713|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.15||||0.053|TWO_SIDED|95.0|0.01|1.4|||Regression, Logistic|Exact method used due to number of responses|Arm 2 (rt-PA and Eptifibitide) represents the numerator, Arm 1 (rt-PA only) the denominator|||1.40|0.01|0.053
72362787|NCT00894803|144236714|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.38||||0.76||95.0|0.35|8.02|||Regression, Logistic||Arm 2 (rt-PA and Eptifibitide) represents the numerator, Arm 1 (rt-PA only) the denominator|||8.02|0.35|0.76
72362788|NCT00894803|144236715|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.99||||0.99999|TWO_SIDED|95.0|0.24|5.92|||Regression, Logistic|Exact method used due to small number of responses|Arm 2 (rt-PA and Eptifibitide) represents the numerator, Arm 1 (rt-PA only) the denominator|||5.92|0.24|0.99999
72362789|NCT00894803|144236716|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.99||||0.99999|TWO_SIDED|95.0|0.24|5.92|||Regression, Logistic|Exact method used due to number of responses|Arm 2 (rt-PA and Eptifibitide) represents the numerator, Arm 1 (rt-PA only) the denominator|||5.92|0.24|0.99999
72362790|NCT00894803|144236717|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.29||||0.78|TWO_SIDED|95.0|0.38|5.76|||Regression, Logistic|Exact methods used due t number of responses|Arm 2 (rt-PA and Eptifibitide) represents the numerator, Arm 1 (rt-PA only) the denominator|||5.76|0.38|0.78
72362791|NCT00894803|144236718|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.92||||0.99999|TWO_SIDED|95.0|0.26|4.18|||Regression, Logistic|Exact method used due to number of responses|Arm 2 (rt-PA and Eptifibitide) represents the numerator, Arm 1 (rt-PA only) the denominator|||4.18|0.26|0.99999
72362792|NCT00894803|144236719|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.52||||0.35|TWO_SIDED|95.0|0.63|3.67|||Regression, Logistic||Arm 2 (rt-PA and Eptifibitide) represents the numerator, Arm 1 (rt-PA only) the denominator|||3.67|0.63|0.35
72362793|NCT00894803|144236719|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.1||||0.85|TWO_SIDED|95.0|0.4|3.02|||Regression, Logistic|adjusting for age, baseline NIHSS and time to IV rt-PA|Arm 2 (rt-PA and Eptifibitide) represents the numerator, Arm 1 (rt-PA only) the denominator|||3.02|0.40|0.85
72362794|NCT00894803|144236720|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.59||||0.3|TWO_SIDED|95.0|0.65|3.88|||Regression, Logistic||Arm 2 (rt-PA and Eptifibitide) represents the numerator, Arm 1 (rt-PA only) the denominator|||3.88|0.65|0.30
72362795|NCT00894803|144236720|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.19||||0.73|TWO_SIDED|95.0|0.44|3.24|||Regression, Logistic|adjusting for age, baseline NIHSS and time to IV rt-PA|Arm 2 (rt-PA and Eptifibitide) represents the numerator, Arm 1 (rt-PA only) the denominator|||3.24|0.44|0.73
72362796|NCT00894803|144236721|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.68||||0.31|TWO_SIDED|95.0|0.61|4.99|||Regression, Logistic||Arm 2 (rt-PA and Eptifibitide) represents the numerator, Arm 1 (rt-PA only) the denominator|||4.99|0.61|0.31
72362797|NCT00894803|144236722|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.39||||0.55|TWO_SIDED|95.0|0.47|4.07|||Regression, Logistic||Arm 2 (rt-PA and Eptifibitide) represents the numerator, Arm 1 (rt-PA only) the denominator|||4.07|0.47|0.55
72362798|NCT00894803|144236723|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.11||||0.82|TWO_SIDED|95.0|0.46|2.67|||Regression, Logistic||Arm 2 (rt-PA and Eptifibitide) represents the numerator, Arm 1 (rt-PA only) the denominator|||2.67|0.46|0.82
72362799|NCT00894803|144236724|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.44||||0.07|TWO_SIDED|95.0|0.9|6.64|||Regression, Logistic||Arm 2 (rt-PA and Eptifibitide) represents the numerator, Arm 1 (rt-PA only) the denominator|||6.64|0.90|0.07
72362800|NCT00894803|144236724|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.98||||0.22|TWO_SIDED|95.0|0.67|5.88|||Regression, Logistic|adjusting for age, baseline NIHSS and time to IV rt-PA|Arm 2 (rt-PA and Eptifibitide) represents the numerator, Arm 1 (rt-PA only) the denominator|||5.88|0.67|0.22
72362801|NCT03337308|144236731|SUPERIORITY||Difference of Least Squares (LS) means|-38.0|STANDARD_ERROR_OF_MEAN|4.32|<|0.001|TWO_SIDED|95.0|-46.5|-29.6|||ANCOVA||Standard Error of the Difference of Least Squares (LS) Means|||-29.6|-46.5|<0.001
72362802|NCT03337308|144236731|SUPERIORITY||Difference of LS means|-19.0|STANDARD_ERROR_OF_MEAN|3.6|<|0.001|TWO_SIDED|95.0|-26.1|-11.9|||ANCOVA||Standard Error of the Difference of LS Means|||-11.9|-26.1|<0.001
72362803|NCT03337308|144236731|SUPERIORITY||Difference of LS means|-13.1|STANDARD_ERROR_OF_MEAN|3.37|<|0.001|TWO_SIDED|95.0|-19.7|-6.5|||ANCOVA||Standard Error of the Difference of LS Means|||-6.5|-19.7|<0.001
72362804|NCT03337308|144236732|SUPERIORITY||Location shift|-46.1|STANDARD_ERROR_OF_MEAN|12.22|<|0.001|TWO_SIDED|99.0|-78.75|-15.78||using alpha = 0.01|Wilcoxon rank sum test||Standard Error of the Hodges-Lehmann Median Difference|||-15.78|-78.75|<0.001
72362805|NCT03337308|144236732|SUPERIORITY||Median Difference (Final Values)|-25.6|STANDARD_ERROR_OF_MEAN|8.14||0.002|TWO_SIDED|98.0|-45.0|-7.15||using alpha = 0.02|Wilcoxon rank sum test||Standard Error of the Hodges-Lehmann Median Difference|||-7.15|-45.00|0.002
72362806|NCT03337308|144236732|SUPERIORITY||Median Difference (Final Values)|-2.6|STANDARD_ERROR_OF_MEAN|8.08||0.734|TWO_SIDED|98.0|-21.35|16.25||using alpha = 0.02|Wilcoxon rank sum test||Standard Error of the Hodges-Lehmann Median Difference|||16.25|-21.35|0.734
72362807|NCT03337308|144236733|SUPERIORITY|using alpha = 0.01|Difference in LS mean|-33.7|STANDARD_ERROR_OF_MEAN|3.97|<|0.001|TWO_SIDED|99.0|-43.9|-23.4|||ANCOVA||Standard Error of the Difference of LS Means|||-23.4|-43.9|<0.001
72362808|NCT03337308|144236733|SUPERIORITY||Difference in LS means|-17.8|STANDARD_ERROR_OF_MEAN|3.12|<|0.001|TWO_SIDED|98.0|-25.1|-10.5||using alpha = 0.02|ANCOVA||Standard Error of the Difference of LS Means|||-10.5|-25.1|<0.001
72362809|NCT03337308|144236733|SUPERIORITY||Difference in LS means|-12.1|STANDARD_ERROR_OF_MEAN|3.03|<|0.001|TWO_SIDED|98.0|-19.1|-5.0||using alpha = 0.02|ANCOVA||Standard Error of the Difference of LS Means|||-5.0|-19.1|<0.001
72362810|NCT03337308|144236734|SUPERIORITY||Difference of LS means|-27.1|STANDARD_ERROR_OF_MEAN|3.11|<|0.001|TWO_SIDED|99.0|-35.1|-19.1||using alpha = 0.01|ANCOVA||Standard Error of the Difference of LS Means|||-19.1|-35.1|<0.001
72362811|NCT03337308|144236734|SUPERIORITY||Difference of LS means|-14.2|STANDARD_ERROR_OF_MEAN|2.64|<|0.001|TWO_SIDED|98.0|-20.4|-8.1||using alpha = 0.02|ANCOVA||Standard Error of the Difference of LS Means|||-8.1|-20.4|<0.001
72362812|NCT03337308|144236734|SUPERIORITY||Difference of LS means|-10.4|STANDARD_ERROR_OF_MEAN|2.48|<|0.001|TWO_SIDED|98.0|-16.1|-4.6||using alpha = 0.02|ANCOVA||Standard Error of the Difference of LS Means|||-4.6|-16.1|<0.001
72362813|NCT03337308|144236735|SUPERIORITY||Difference of LS means|-30.1|STANDARD_ERROR_OF_MEAN|3.81|<|0.001|TWO_SIDED|99.0|-39.9|-20.3||using alpha = 0.01|ANCOVA||Standard Error of the Difference of LS Means|||-20.3|-39.9|<0.001
72362814|NCT03337308|144236735|SUPERIORITY||Difference of LS means|-12.8|STANDARD_ERROR_OF_MEAN|3.23|<|0.001|TWO_SIDED|98.0|-20.3|-5.3||using alpha = 0.02|ANCOVA||Standard Error of the Difference of LS Means|||-5.3|-20.3|<0.001
72362815|NCT03337308|144236735|SUPERIORITY||Difference of LS means|-9.3|STANDARD_ERROR_OF_MEAN|3.09||0.003|TWO_SIDED|98.0|-16.5|-2.1||using alpha = 0.02|ANCOVA||Standard Error of the Difference of LS Means|||-2.1|-16.5|0.003
72362816|NCT01668784|144236738|SUPERIORITY||Hazard Ratio (HR)|0.73||||0.0018|TWO_SIDED|98.52|0.57|0.93||The boundary for statistical significance required the p-value to be less than 0.0148 at the interim analyses.|Log Rank|Log-rank Test stratified by the Memorial Sloan-Kettering Cancer Center risk group, number of prior anti-angiogenic therapies, and the region.|Stratified Cox proportional hazard model. Hazard ratio (HR) was Nivolumab over Everolimus.|||0.93|0.57|0.0018
72362817|NCT01668784|144236742|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.034|TWO_SIDED|95.0|0.72|0.99|||Log Rank|Log-rank Test stratified by the Memorial Sloan-Kettering Cancer Center (MSKCC) risk group, number of prior anti-angiogenic therapies, and the region.|Stratified Cox proportional hazard model. Hazard ratio is nivolumab over everolimus.|||0.99|0.72|0.0340
72362818|NCT01668784|144236748|SUPERIORITY||Stratified Cox Proportional hazard Model|0.74||||0.0001|TWO_SIDED|95.0|0.63|0.86|||Log Rank|||||0.86|0.63|0.0001
72362819|NCT02867436|144236757|SUPERIORITY||Mean Difference (Final Values)|205.0|||<|0.05|TWO_SIDED|95.0|-223.0|633.0|||Regression, Linear|||||633|-223|<0.05
72362820|NCT02867436|144236758|SUPERIORITY||Mean Difference (Final Values)|-7.8|||<|0.05|TWO_SIDED|95.0|-14.1|-1.6|||Regression, Linear|||||-1.6|-14.1|<0.05
72362821|NCT02867436|144236759|SUPERIORITY||Mean Difference (Final Values)|-0.15|||<|0.05|TWO_SIDED|95.0|-0.31|0.01|||Regression, Linear|||||0.01|-0.31|<0.05
72362822|NCT02867436|144236760|SUPERIORITY||||||<|0.05|||||||t-test, 1 sided|||||||<0.05
72362823|NCT02867436|144236761|SUPERIORITY||||||<|0.05||||||After Benjamini-Hochberg correction for multiple comparisons|ANOVA|||||||<0.05
72362824|NCT05178173|144236773|SUPERIORITY|||||||0.59||||||The a priori threshold for statistical significance is \<0.05.|Mixed Models Analysis|||SARS CoV-2 N1||||0.59
72362825|NCT05178173|144236773|SUPERIORITY|||||||0.18||||||The a priori threshold for statistical significance is \<0.05.|Mixed Models Analysis|||SARS CoV-2 N1||||0.18
72362826|NCT05178173|144236773|SUPERIORITY|||||||0.78||||||The a priori threshold for statistical significance is \<0.05.|Mixed Models Analysis|||SARS CoV-2 N2||||0.78
72362827|NCT05178173|144236773|SUPERIORITY|||||||0.08||||||The a priori threshold for statistical significance is \<0.05.|Mixed Models Analysis|||SARS CoV-2 N2||||0.08
72362828|NCT04272242|144236800|EQUIVALENCE|GMRs and associated 90% confidence intervals were calculated to assess the overall effect of 1HP on DTG PK.|Geometric Mean Ratio|0.92|||||TWO_SIDED|90.0|0.91|0.93|||||The numerator represents Day 28 and the denominator represents Entry.|Statistical analysis for Cmax, comparing Day 28 to Day 0.||0.93|0.91|
72362829|NCT04272242|144236801|EQUIVALENCE|GMRs and associated 90% confidence intervals were calculated to assess the overall effect of 1HP on DTG PK.|Geometric Mean Ratio|0.96|||||TWO_SIDED|90.0|0.96|0.96|||||The numerator represents Day 28 and the denominator represents Entry.|Statistical analysis for AUC0-24, comparing Day 28 to Day 0.||0.96|0.96|
72362830|NCT04272242|144236802|EQUIVALENCE|GMRs and associated 90% confidence intervals were calculated to assess the overall effect of 1HP on DTG PK.|Geometric Mean Ratio|0.99|||||TWO_SIDED|90.0|0.97|1.0|||||The numerator represents Day 28 and the denominator represents Entry.|Statistical analysis for Cmin, comparing Day 28 to Day 0.||1.00|0.97|
72362831|NCT02711891|144236830|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8|||||||Paired Sample T-test|||||||0.8
72362832|NCT02711891|144236830|SUPERIORITY_OR_OTHER_LEGACY|||||||0.003|||||||Paired Sample T-test|||||||.003
72362833|NCT02711891|144236830|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002|||||||t-test, 2 sided|||||||0.002
72362834|NCT02711891|144236832|SUPERIORITY_OR_OTHER_LEGACY|||||||0.01|||||||t-test, 1 sided|||||||0.01
72362835|NCT02711891|144236832|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|TWO_SIDED|0.05|||||Chi-squared|||||||.001
72362836|NCT02711891|144236834|SUPERIORITY_OR_OTHER_LEGACY|||||||0.876||||||Comparison of mean BPM during lance procedure for L1 vs L2 Loperamide.|t-test, 1 sided|||The population BPM lance one = population BPM mean lance two. Loperamide 1= Loperamide 2. Placebo 1=Placebo 2.||||.876
72362837|NCT02711891|144236834|SUPERIORITY_OR_OTHER_LEGACY|||||||0.085||||||Comparison of the mean between HR one and HR two during the procedure for lance one will equal the mean HR lance two following loperamide gel application.|ANOVA|df 16.||Mean HR during the procedure for lance one will equal mean HR lance two following loperamide gel applciation||||.085
72362838|NCT00781768|144236843|SUPERIORITY||Odds Ratio (OR)|2.3|||<|0.001|TWO_SIDED||||||Chi-squared|||The null hypothesis is that there will be a higher proportion of complete responders among those subjects receiving the combination therapy.||||<.001
72362839|NCT02458313|144236849|SUPERIORITY|DMXB-A vs. Placebo groups compared at baseline||||||0.647|||||||t-test, 2 sided|||||||0.647
72362840|NCT02458313|144236849|SUPERIORITY|||||||0.679|||||||t-test, 2 sided|||DMXB-A vs. Placebo groups compared post-intervention||||0.679
72362841|NCT02458313|144236850|SUPERIORITY|||||||0.951|||||||t-test, 2 sided|||DMXB-A vs. Placebo groups compared at baseline||||0.951
72362842|NCT02458313|144236850|SUPERIORITY|||||||0.884|||||||t-test, 2 sided|||DMXB-A vs. Placebo groups compared post-intervention||||0.884
72362843|NCT04944992|144236885|SUPERIORITY||Difference in least squared means|30.4|||<|0.0001|TWO_SIDED|90.0|22.1|38.7|||Mixed Models Analysis|||||38.7|22.1|<0.0001
72362844|NCT04944992|144236886|OTHER|Difference (Efinopegdutide - Semaglutide) in %|difference in percentage|16.3||||||95.0|3.5|29.1||||||||29.1|3.5|
72362845|NCT04944992|144236887|OTHER|Difference (Efinopegdutide - Semaglutide) in %|Difference in percentage|5.6||||||95.0|0.4|13.5||||||||13.5|0.4|
72362846|NCT04944992|144236888|SUPERIORITY||Difference in least squared means|6.1|||<|0.001|TWO_SIDED|90.0|4.6|7.7|||Mixed Models Analysis|||||7.7|4.6|<0.001
72362847|NCT04944992|144236889|SUPERIORITY||Difference in Least Squared Means|-1.4||||0.085|TWO_SIDED|90.0|-2.7|-0.1|||Mixed Models Analysis|||||-0.1|-2.7|0.085
72362848|NCT04944992|144236890|OTHER|Difference (Efinopegdutide - Semaglutide) in %|Difference in Least Squared Means|-7.2|||||TWO_SIDED|90.0|-11.2|-3.1||||||||-3.1|-11.2|
72362849|NCT04944992|144236891|OTHER|Difference (Efinopegdutide - Semaglutide) in %|Difference in least squared means|-5.7||||||90.0|-10.9|-0.6||||||||-0.6|-10.9|
72362850|NCT04944992|144236892|OTHER|Difference (Efinopegdutide - Semaglutide) in %|Difference in least squared means|-11.7||||||90.0|-15.8|-7.7||||||||-7.7|-15.8|
72362851|NCT04944992|144236893|OTHER|Difference (Efinopegdutide - Semaglutide) in %|Difference in least squared means|-6.1||||||90.0|-12.0|-0.1||||||||-0.1|-12.0|
72362852|NCT04944992|144236894|OTHER|Difference (Efinopegdutide - Semaglutide) in %|Difference in least squared means|-7.6|||||TWO_SIDED|90.0|-14.3|-0.9||||||||-0.9|-14.3|
72362853|NCT04944992|144236895|OTHER|Difference (Efinopegdutide - Semaglutide) in %|Difference in least squared means|-5.4|||||TWO_SIDED|90.0|-10.4|-0.4||||||||-0.4|-10.4|
72362854|NCT01295814|144236896|NON_INFERIORITY_OR_EQUIVALENCE|"The study had acceptable sensitivity with a statistical power of 0.99 (99%) for the improvement in the adalimumab group from baseline to week 12.~The study had acceptable sensitivity with a statistical power of 0.92 (92%) for the improvement in the placebo group from baseline to week 12."|Mean Difference (Final Values)|7.9||||0.75|TWO_SIDED|95.0|4.0|11.8||Statistical improvement in the adalimumab group compared to the placebo group from baseline to week 12.|t-test, 2 sided||Confidence interval was improvement in OSPI in the adalimumab group from baseline to week 12.|Statistical improvement in the adalimumab group compared to the placebo group from baseline to week 12.||11.8|4.0|0.75
72362855|NCT01295814|144236897|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.0||||0.99|TWO_SIDED|95.0|1.7|6.3||Statistical improvement in the adalimumab group compared to the placebo group from baseline to week 12.|t-test, 2 sided||Confidence interval was improvement in ICSI in the adalimumab group from baseline to week 12.|Statistical improvement in the adalimumab group compared to the placebo group from baseline to week 12.||6.3|1.7|0.99
72362856|NCT01295814|144236898|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.9||||0.76|TWO_SIDED|95.0|2.1|5.8||Statistical improvement in the adalimumab group compared to the placebo group from baseline to week 12.|t-test, 2 sided||Confidence interval was improvement in ICPI in the adalimumab group from baseline to week 12.|Statistical improvement in the adalimumab group compared to the placebo group from baseline to week 12.||5.8|2.1|0.76
72362857|NCT01295814|144236899|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.3||||0.76|TWO_SIDED|95.0|2.6|10.0||Statistical improvement in the adalimumab group compared to the placebo group from baseline to week 12.|t-test, 2 sided||Confidence interval was improvement in PUF in the adalimumab group from baseline to week 12.|Statistical improvement in the adalimumab group compared to the placebo group from baseline to week 12.||10.0|2.6|0.76
72362858|NCT01295814|144236900|SUPERIORITY_OR_OTHER|||||||0.67||95.0||||Statistical improvement in the adalimumab group compared to the placebo group from baseline to week 12.|t-test, 2 sided|||Statistical improvement in the adalimumab group compared to the placebo group from baseline to week 12.||||0.67
72362859|NCT03414983|144236901|SUPERIORITY||Hazard Ratio (HR)|0.81||||0.3022|TWO_SIDED|80.0|0.61|1.07||Stratified regular log-rank test|Log Rank||Stratified Cox proportional hazard model|Hazard Ratio is Arm A: NIV+mFOLFOX+BEV over Arm B: mFOLFOX+BEV||1.07|0.61|0.3022
72362860|NCT03414983|144236901|SUPERIORITY||Hazard Ratio (HR)|0.81||||0.3022|TWO_SIDED|95.0|0.53|1.23||Stratified regular log-rank test|Log Rank||Stratified Cox proportional hazard model|Hazard Ratio is Arm A: NIV+mFOLFOX+BEV over Arm B: mFOLFOX+BEV||1.23|0.53|0.3022
72362861|NCT03414983|144236902|SUPERIORITY||Hazard Ratio (HR)|0.8|||||TWO_SIDED|95.0|0.54|1.19|||||Stratified Cox proportional hazard model|Hazard Ratio is Arm A: NIV+mFOLFOX+BEV over Arm B: mFOLFOX+BEV||1.19|0.54|
72362862|NCT03414983|144236917|SUPERIORITY||Hazard Ratio (HR)|0.88||||0.5041|TWO_SIDED|80.0|0.67|1.15||Stratified regular log-rank test|Log Rank||Stratified Cox proportional hazard model|Hazard Ratio is Arm A: NIV+mFOLFOX+BEV over Arm B: mFOLFOX+BEV||1.15|0.67|0.5041
72362863|NCT03414983|144236917|SUPERIORITY||Hazard Ratio (HR)|0.88||||0.5041|TWO_SIDED|95.0|0.58|1.32||Stratified regular log-rank test|Log Rank||Stratified Cox proportional hazard model|Hazard Ratio is Arm A: NIV+mFOLFOX+BEV over Arm B: mFOLFOX+BEV||1.32|0.58|0.5041
72362864|NCT00303069|144236919|SUPERIORITY_OR_OTHER||Risk Difference (RD)|84.5|||<|0.001|TWO_SIDED|95.0|65.2|93.6||P-value \< 0.025 considered significant.|Chi-squared|Normal approximation for testing 2 independent binomial proportions, stratified by age group (\<40 yrs, ≥40 yrs)|Risk Difference is 90 μg minus Placebo and is expressed in percentage points, confidence intervals were computed using the stratified method given by Miettinen and Nurminen|Testing was performed in a sequential manner. First, the response rate of the 90-μg group was compared to placebo and assessed for significance (using a 1-tailed α=0.025). If significant, the response rate of the 30-μg group was compared to placebo and assessed for significance. The testing continued sequentially until a non-significant result was observed or until all V710 groups had been compared with placebo.||93.6|65.2|<0.001
72362865|NCT00303069|144236919|SUPERIORITY_OR_OTHER||Risk Difference (RD)|81.6|||<|0.01|TWO_SIDED|95.0|61.6|92.0||P-value \< 0.025 considered significant.|Chi-squared|Normal approximation for testing 2 independent binomial proportions, stratified by age group (\<40 yrs, ≥40 yrs)|Risk Difference is 30 μg minus Placebo and is expressed in percentage points, confidence intervals were computed using the stratified method given by Miettinen and Nurminen|Testing was performed in a sequential manner. First, the response rate of the 90-μg group was compared to placebo and assessed for significance (using a 1-tailed α=0.025). If significant, the response rate of the 30-μg group was compared to placebo and assessed for significance. The testing continued sequentially until a non-significant result was observed or until all V710 groups had been compared with placebo.||92.0|61.6|<0.01
72368490|NCT02304367|144247135|OTHER|||||||0.542|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline 24-hour urinary phosphorus.||Week 168||||0.542
72362866|NCT00303069|144236919|SUPERIORITY_OR_OTHER||Risk Difference (RD)|25.0|||<|0.001|TWO_SIDED|95.0|6.7|43.8||P-value \< 0.025 considered significant.|Chi-squared|Normal approximation for testing 2 independent binomial proportions, stratified by age group (\<40 yrs, ≥40 yrs)|Risk Difference is 5 μg minus Placebo and is expressed in percentage points, confidence intervals were computed using the stratified method given by Miettinen and Nurminen|Testing was performed in a sequential manner. First, the response rate of the 90-μg group was compared to placebo and assessed for significance (using a 1-tailed α=0.025). If significant, the response rate of the 30-μg group was compared to placebo and assessed for significance. The testing continued sequentially until a non-significant result was observed or until all V710 groups had been compared with placebo.||43.8|6.7|<0.001
72362867|NCT00303069|144236920|SUPERIORITY_OR_OTHER||Risk Difference (RD)|30.9|||<|0.001|TWO_SIDED|95.0|17.2|48.3||P-value \< 0.025 considered significant.|Chi-squared|Normal approximation for testing 2 independent binomial proportions, stratified by age group (\<40 yrs, ≥40 yrs)|Risk Difference is 90 μg minus Placebo and is expressed in percentage points, confidence intervals were computed using the stratified method given by Miettinen and Nurminen|Testing was performed in a sequential manner. First, the response rate of the 90-μg group was compared to placebo and assessed for significance (using a 1-tailed α=0.025). If significant, the response rate of the 30-μg group was compared to placebo and assessed for significance. The testing continued sequentially until a non-significant result was observed or until all V710 groups had been compared with placebo.||48.3|17.2|<0.001
72362868|NCT00303069|144236920|SUPERIORITY_OR_OTHER||Risk Difference (RD)|14.4|||<|0.001|TWO_SIDED|95.0|1.6|32.1||P-value \< 0.025 considered significant.|Chi-squared|Normal approximation for testing 2 independent binomial proportions, stratified by age group (\<40 yrs, ≥40 yrs)|Risk Difference is 30 μg minus Placebo and is expressed in percentage points, confidence intervals were computed using the stratified method given by Miettinen and Nurminen|Testing was performed in a sequential manner. First, the response rate of the 90-μg group was compared to placebo and assessed for significance (using a 1-tailed α=0.025). If significant, the response rate of the 30-μg group was compared to placebo and assessed for significance. The testing continued sequentially until a non-significant result was observed or until all V710 groups had been compared with placebo.||32.1|1.6|<0.001
72362869|NCT00303069|144236920|SUPERIORITY_OR_OTHER||Risk Difference (RD)|3.5|||<|0.001|TWO_SIDED|95.0|-8.2|16.9||P-value \< 0.025 considered significant.|Chi-squared|Normal approximation for testing 2 independent binomial proportions, stratified by age group (\<40 yrs, ≥40 yrs)|Risk Difference is 5 μg minus Placebo and is expressed in percentage points, confidence intervals were computed using the stratified method given by Miettinen and Nurminen|Testing was performed in a sequential manner. First, the response rate of the 90-μg group was compared to placebo and assessed for significance (using a 1-tailed α=0.025). If significant, the response rate of the 30-μg group was compared to placebo and assessed for significance. The testing continued sequentially until a non-significant result was observed or until all V710 groups had been compared with placebo.||16.9|-8.2|<0.001
72362870|NCT02958917|144236930|SUPERIORITY||Mean Difference (Final Values)|-0.76|||<|0.05|TWO_SIDED|95.0|||||Mixed Models Analysis|||||||<0.05
72362871|NCT02958917|144236931|SUPERIORITY||Cox Proportional Hazard|0.264|||<|0.05|TWO_SIDED|95.0|||||Regression, Cox|||||||<0.05
72362872|NCT02958917|144236932|SUPERIORITY||Slope|2.03|||<|0.05|TWO_SIDED|95.0|||||Mixed Models Analysis|||||||<0.05
72362873|NCT02958917|144236933|SUPERIORITY||Median Difference (Final Values)|-0.108|||<|0.05|TWO_SIDED|95.0|||||Mixed Models Analysis|||||||<0.05
72362874|NCT02958917|144236934|SUPERIORITY||Risk Difference (RD)|0.364|||<|0.05|TWO_SIDED||||||Log Rank|||||||<0.05
72362875|NCT02958917|144236935|SUPERIORITY||Risk Difference (RD)|0.128|||<|0.05|TWO_SIDED|95.0|||||Log Rank|||||||<0.05
72362876|NCT02958917|144236936|SUPERIORITY||Mean Difference (Final Values)|-2.05|||<|0.05|TWO_SIDED|95.0|||||Mixed Models Analysis|||||||<0.05
72362877|NCT02958917|144236937|SUPERIORITY||Mean Difference (Final Values)|-6.72|||<|0.05|TWO_SIDED|95.0|||||Mixed Models Analysis|||||||<0.05
72362878|NCT02958917|144236938|SUPERIORITY||Mean Difference (Final Values)|-4.92|||<|0.05|TWO_SIDED|95.0|||||Mixed Models Analysis|||||||<0.05
72362879|NCT02958917|144236939|SUPERIORITY||Mean Difference (Final Values)|-7.92|||<|0.05|TWO_SIDED|95.0|||||Mixed Models Analysis|||||||<0.05
72429378|NCT00479037|144369732|SUPERIORITY_OR_OTHER||Mean Difference (Net)|360.3|||<|0.0001|TWO_SIDED|95.0|256.5|494.3||P-values corresponding to the tests of treatment effect for the primary endpoints were adjusted using the Hochberg procedure.|ANCOVA|||The bone marker values were log-transformed for the primary analysis as they were heavily skewed. Changes in log-transformed bone marker values were analyzed using an analysis of covariance (ANCOVA) with treatment and center as fixed effects and the baseline bone marker value as a covariate. An F-test was used to test the effect of treatment and the least square means were computed to assess the clinical difference between treatment groups.||494.3|256.5|<0.0001
72362880|NCT02958917|144236940|SUPERIORITY||Mean Difference (Final Values)|-2.05|||<|0.05|TWO_SIDED|95.0|||||Mixed Models Analysis|||||||<0.05
72362881|NCT02364700|144236968|EQUIVALENCE|Group means from baseline to discharge were compared to determine if 6-week and training on the Hand of Hope device elicited changes in outcome measures.|||||<|0.05|||||||Friedman Test|||||||<.05
72362882|NCT00804908|144236974|SUPERIORITY_OR_OTHER||||||=|0.071|||||||Stratified log-rank|||Comparisons between treatment groups were performed using a Comparisons between treatment groups were performed using a log-rank test stratified by baseline lactate dehydrogenase (LDH) status (0 to 1 ULN; \>1 to ≤ 2 ULN) and history of previously treated brain metastases (with, without). Hochberg testing procedure for multiplicity adjustment.||||=0.071
72362883|NCT00804908|144236974|SUPERIORITY_OR_OTHER||||||=|0.233|||||||Stratified log-rank|||Comparisons between treatment groups were performed using a Comparisons between treatment groups were performed using a log-rank test stratified by baseline lactate dehydrogenase (LDH) status (0 to 1 ULN; \>1 to ≤ 2 ULN) and history of previously treated brain metastases (with, without). Hochberg testing procedure for multiplicity adjustment.||||=0.233
72362884|NCT01280903|144236982|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||||||<.0001
72362885|NCT01280903|144236983|SUPERIORITY|||||||0.13||||||p=0.130 for None to very low|Mixed Models Analysis|||||||0.130
72362886|NCT01280903|144236983|SUPERIORITY|||||||0.573||||||p=0.573 for Light|Mixed Models Analysis|||||||0.573
72362887|NCT01280903|144236983|SUPERIORITY|||||||0.197||||||p=0.197 for Moderate-to-vigorous|Mixed Models Analysis|||||||0.197
72362888|NCT01280903|144236984|SUPERIORITY|||||||0.461|||||||Mixed Models Analysis|||||||0.461
72362889|NCT01280903|144236985|SUPERIORITY|||||||0.18|||||||Mixed Models Analysis|||||||0.180
72362890|NCT01280903|144236986|SUPERIORITY|||||||0.258|||||||Mixed Models Analysis|||||||0.258
72362891|NCT01280903|144236987|SUPERIORITY|||||||0.416|||||||Mixed Models Analysis|||||||0.416
72362892|NCT01280903|144236988|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||||||<.0001
72362893|NCT01280903|144236989|SUPERIORITY|||||||0.272||||||p=0.272 for None to very low|Mixed Models Analysis|||||||0.272
72362894|NCT01280903|144236989|SUPERIORITY|||||||0.823||||||p=0.823 for Light|Mixed Models Analysis|||||||0.823
72362895|NCT01280903|144236989|SUPERIORITY|||||||0.076||||||p=0.076 for Moderate-to-vigorous|Mixed Models Analysis|||||||0.076
72362896|NCT01280903|144236990|SUPERIORITY|||||||0.561|||||||Mixed Models Analysis|||||||0.561
72362897|NCT01280903|144236991|SUPERIORITY|||||||0.856|||||||Mixed Models Analysis|||||||0.856
72362898|NCT01280903|144236992|SUPERIORITY|||||||0.292|||||||Mixed Models Analysis|||||||0.292
72362899|NCT01280903|144236993|SUPERIORITY|||||||0.396|||||||Mixed Models Analysis|||||||0.396
72362900|NCT01280903|144236994|SUPERIORITY|||||||0.424|||||||Mixed Models Analysis|||||||0.424
72362901|NCT01280903|144236995|SUPERIORITY|||||||0.586|||||||Mixed Models Analysis|||||||0.586
72362902|NCT01280903|144236996|SUPERIORITY|||||||0.596|||||||Mixed Models Analysis|||||||0.596
72362903|NCT01280903|144236997|SUPERIORITY|||||||0.639|||||||Mixed Models Analysis|||||||0.639
72362904|NCT01280903|144236998|SUPERIORITY|||||||0.466|||||||Mixed Models Analysis|||||||0.466
72362905|NCT01280903|144236999|SUPERIORITY|||||||0.322||||||p=0.322 for Short Form-36v2 Mental Component|Mixed Models Analysis|||||||0.322
72362906|NCT01280903|144236999|SUPERIORITY|||||||0.979||||||p=0.979 for Short Form-36v2 Physical Component|Mixed Models Analysis|||||||0.979
72362907|NCT01280903|144237000|SUPERIORITY|||||||0.71||||||p=0.710 for Exercise Barriers Self-Efficacy|Mixed Models Analysis|||||||0.710
72362908|NCT01280903|144237000|SUPERIORITY|||||||0.133||||||p=0.133 for Exercise Self-Efficacy|Mixed Models Analysis|||||||0.133
72362909|NCT01280903|144237001|SUPERIORITY|||||||0.005||||||p=0.005 for Arthritis Self Efficacy Pain|Mixed Models Analysis|||||||0.005
72362910|NCT01280903|144237001|SUPERIORITY|||||||0.948||||||p=0.948 for Arthritis Self Efficacy Function|Mixed Models Analysis|||||||0.948
72362911|NCT01280903|144237001|SUPERIORITY|||||||0.663||||||p=0.663 for Arthritis Self Efficacy Other Symptoms|Mixed Models Analysis|||||||0.663
72362912|NCT01280903|144237002|SUPERIORITY|||||||0.001||||||p=0.001 for Perceived Therapeutic Efficacy of Exercise and Arthritis|Mixed Models Analysis|||||||0.001
72362913|NCT01280903|144237002|SUPERIORITY|||||||0.031||||||p=0.031 for Perceived Therapeutic Efficacy of Exercise and Hypertension|Mixed Models Analysis|||||||0.031
72362914|NCT01280903|144237003|SUPERIORITY|||||||0.816|||||||Mixed Models Analysis|||||||0.816
72362915|NCT01280903|144237004|SUPERIORITY|||||||0.895|||||||Mixed Models Analysis|||||||0.895
72362916|NCT01280903|144237005|SUPERIORITY|||||||0.26|||||||Mixed Models Analysis|||||||0.260
72362917|NCT01280903|144237006|SUPERIORITY|||||||0.993|||||||Mixed Models Analysis|||||||0.993
72362918|NCT01280903|144237007|SUPERIORITY|||||||0.947|||||||Mixed Models Analysis|||||||0.947
72362919|NCT01280903|144237008|SUPERIORITY|||||||0.406||||||p=0.406 for Short Form-36v2 Mental Component|Mixed Models Analysis|||||||0.406
72362920|NCT01280903|144237008|SUPERIORITY|||||||0.826||||||p=0.826 for Short Form-36v2 Physical Component|Mixed Models Analysis|||||||0.826
72362921|NCT01280903|144237009|SUPERIORITY|||||||0.95||||||p=0.950 for Exercise Barriers Self-Efficacy|Mixed Models Analysis|||||||0.950
72362922|NCT01280903|144237009|SUPERIORITY|||||||0.365||||||p=0.365 for Exercise Self-Efficacy|Mixed Models Analysis|||||||0.365
72362923|NCT01280903|144237010|SUPERIORITY|||||||0.219||||||p=0.219 for Arthritis Self Efficacy Pain|Mixed Models Analysis|||||||0.219
72362924|NCT01280903|144237010|SUPERIORITY|||||||0.34||||||p=0.340 for Arthritis Self Efficacy Function|Mixed Models Analysis|||||||0.340
72362925|NCT01280903|144237010|SUPERIORITY|||||||0.806||||||p=0.806 for Arthritis Self Efficacy Other Symptoms|Mixed Models Analysis|||||||0.806
72362926|NCT01280903|144237011|SUPERIORITY|||||||0.008||||||p=0.008 for Perceived Therapeutic Efficacy of Exercise and Arthritis|Mixed Models Analysis|||||||0.008
72362927|NCT01280903|144237011|SUPERIORITY|||||||0.12||||||p=0.120 for Perceived Therapeutic Efficacy of Exercise and Hypertension|t-test, 1 sided|||||||0.120
72362928|NCT01428258|144237016|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-147.0|STANDARD_ERROR_OF_MEAN|39.0||0.0008|TWO_SIDED||||||ANCOVA|||||||0.0008
72362929|NCT01428258|144237016|OTHER|||||||0.136|||||||ANCOVA|||||||0.136
72362930|NCT01428258|144237016|OTHER|||||||0.044|||||||ANCOVA|||||||0.044
72362931|NCT01428258|144237017|OTHER|||||||0.576|||||||ANOVA|||||||0.576
72362932|NCT01428258|144237018|OTHER|||||||0.902|||||||t-test, 2 sided|||||||0.902
72362933|NCT01428258|144237019|OTHER|||||||0.797|||||||t-test, 2 sided|||||||0.797
72362934|NCT01428258|144237020|OTHER|||||||0.0001|||||||ANOVA|||||||0.0001
72362935|NCT01968447|144237044|SUPERIORITY_OR_OTHER_LEGACY|||||||0.59|TWO_SIDED||||||Mixed Models Analysis|||||||0.59
72362936|NCT02766023|144237051|SUPERIORITY||Risk Difference (RD)|0.04||||0.467|TWO_SIDED|95.0|-0.1|0.18|||Fisher Exact|||||0.18|-0.10|0.467
72362937|NCT02766023|144237052|SUPERIORITY||Odds Ratio (OR)|0.54||||0.031|TWO_SIDED|95.0|0.3|0.95|||Chi-squared|||||0.95|0.30|0.031
72362938|NCT02766023|144237053|SUPERIORITY||Risk Difference (RD)|0.03||||0.643|TWO_SIDED|95.0|-0.08|0.15|||Chi-squared|||Analysis is for self-reported compliance||0.15|-0.08|0.643
72362939|NCT02766023|144237053|SUPERIORITY||Risk Difference (RD)|0.05||||0.446|TWO_SIDED|95.0|-0.07|0.17|||Chi-squared|||Analysis is for compliance assessed by staining.||0.17|-0.07|0.446
72362940|NCT02766023|144237062|SUPERIORITY||Odds Ratio (OR)|79.64|||<|0.001|TWO_SIDED|95.0|29.02|218.57|||Chi-squared|||||218.57|29.02|<0.001
72362941|NCT02766023|144237070|SUPERIORITY||Odds Ratio (OR)|72.78|||<|0.001|TWO_SIDED|95.0|28.07|188.66|||Chi-squared|||||188.66|28.07|<0.001
72362942|NCT02766023|144237071|SUPERIORITY||Odds Ratio (OR)|0.54||||0.03|TWO_SIDED|95.0|0.31|0.94|||Chi-squared|||||0.94|0.31|0.030
72362943|NCT04026113|144237083|SUPERIORITY||Difference|1.17|STANDARD_ERROR_OF_MEAN|0.264|<|0.0001|TWO_SIDED|95.0|0.651|1.689||ANCOVA model estimates/t-tests comparing specified treatment groups, controlling for age group and baseline value.|ANCOVA|||||1.689|0.651|< 0.0001
72362944|NCT04026113|144237083|SUPERIORITY|||||||0.4323||||||Treatment-by-Age Group Interaction P-value: Interaction P-value base on ANCOVA model with treatment, age group, treatment-by-age group interaction as factors and baseline value as a covariate.|ANCOVA|||||||0.4323
72362945|NCT04026113|144237085|SUPERIORITY||Difference|0.423|STANDARD_ERROR_OF_MEAN|0.109||0.0001|TWO_SIDED|95.0|0.208|0.638||ANCOVA model estimates/t-tests comparing specified treatment groups, controlling for age group and baseline value.|ANCOVA|||||0.638|0.208|0.0001
72362946|NCT04026113|144237085|SUPERIORITY|||||||0.4381||||||Treatment-by-Age Group Interaction P-value: Interaction P-value base on ANCOVA model with treatment, age group, treatment-by-age group interaction as factors and baseline value as a covariate.|ANCOVA|||||||0.4381
72362947|NCT04613362|144237103|SUPERIORITY||Odds Ratio (OR)|0.82||||0.61|TWO_SIDED|95.0|0.34|1.97||adjusted for gender which is included as a covariate|Mixed Models Analysis|||||1.97|0.34|0.61
72362948|NCT04613362|144237105|SUPERIORITY||Mean Difference (Net)|-8.8028|STANDARD_ERROR_OF_MEAN|6.3895||0.1724|TWO_SIDED|95.0|-21.5314|3.9257|||Mixed Models Analysis|||3 month||3.9257|-21.5314|0.1724
72362949|NCT04613362|144237105|SUPERIORITY||Mean Difference (Net)|-4.6533|STANDARD_ERROR_OF_MEAN|5.9929||0.4399|TWO_SIDED|95.0|-16.5917|7.2851|||Mixed Models Analysis|||6 months||7.2851|-16.5917|0.4399
72362950|NCT04613362|144237106|SUPERIORITY||Mean Difference (Net)|18.7886|STANDARD_ERROR_OF_MEAN|18.0826||0.3021|TWO_SIDED|95.0|-17.2261|54.8032|||Mixed Models Analysis|||3 months||54.8032|-17.2261|0.3021
72362951|NCT04613362|144237106|SUPERIORITY||Mean Difference (Net)|-5.1996|STANDARD_ERROR_OF_MEAN|17.1338||0.7624|TWO_SIDED|95.0|-39.3245|28.9254|||Mixed Models Analysis|||6 months||28.9254|-39.3245|0.7624
72362952|NCT04613362|144237107|SUPERIORITY||Mean Difference (Net)|5.9613|STANDARD_ERROR_OF_MEAN|4.3867||0.1783|TWO_SIDED|95.0|-2.7794|14.7019|||Mixed Models Analysis|||3 months||14.7019|-2.7794|0.1783
72362953|NCT04613362|144237107|SUPERIORITY||Mean Difference (Net)|-0.2145|STANDARD_ERROR_OF_MEAN|4.1565||0.959|TWO_SIDED|95.0|-8.4965|8.0675|||Mixed Models Analysis|||6 months||8.0675|-8.4965|0.959
72362954|NCT04613362|144237108|SUPERIORITY||Mean Difference (Net)|-12.6627|STANDARD_ERROR_OF_MEAN|7.3097||0.0873|TWO_SIDED|95.0|-27.2243|1.8989|||Mixed Models Analysis|||3 months||1.8989|-27.2243|0.0873
72362955|NCT04613362|144237108|SUPERIORITY||Mean Difference (Net)|-7.3578|STANDARD_ERROR_OF_MEAN|6.8559||0.2866|TWO_SIDED|95.0|-21.0154|6.2999|||Mixed Models Analysis|||6 months||6.2999|-21.0154|0.2866
72362956|NCT04613362|144237110|SUPERIORITY||Mean Difference (Net)|-1.5655|STANDARD_ERROR_OF_MEAN|1.4313||0.2776|TWO_SIDED|95.0|-4.4168|1.2859|||Mixed Models Analysis|||3 months||1.2859|-4.4168|0.2776
72362957|NCT04613362|144237110|SUPERIORITY||Mean Difference (Net)|0.7202|STANDARD_ERROR_OF_MEAN|1.6492||0.6636|TWO_SIDED|95.0|-2.5651|4.0055|||Mixed Models Analysis|||6 months||4.0055|-2.5651|0.6636
72362958|NCT04613362|144237111|SUPERIORITY||Mean Difference (Net)|2.3254|STANDARD_ERROR_OF_MEAN|1.6911||0.1733|TWO_SIDED|95.0|-1.0443|5.695|||Mixed Models Analysis|||3 months||5.695|-1.0443|0.1733
72362959|NCT04613362|144237111|SUPERIORITY||Mean Difference (Net)|-0.5408|STANDARD_ERROR_OF_MEAN|1.622||0.7398|TWO_SIDED|95.0|-3.7726|2.6911|||Mixed Models Analysis|||6 months||2.6911|-3.7726|0.7398
72362960|NCT04613362|144237112|SUPERIORITY||Mean Difference (Net)|-0.1491|STANDARD_ERROR_OF_MEAN|1.5551||0.9239|TWO_SIDED|95.0|-3.2476|2.9494|||Mixed Models Analysis|||Physical Component Scale - 3 months||2.9494|-3.2476|0.9239
72362961|NCT04613362|144237112|SUPERIORITY||Mean Difference (Net)|-0.2879|STANDARD_ERROR_OF_MEAN|1.4735||0.8456|TWO_SIDED|95.0|-3.2238|2.6481|||Mixed Models Analysis|||Physical Component Scale - 6 months||2.6481|-3.2238|0.8456
72362962|NCT04613362|144237112|SUPERIORITY||Mean Difference (Net)|-0.1757|STANDARD_ERROR_OF_MEAN|2.3798||0.9413|TWO_SIDED|95.0|-4.9175|4.5661|||Mixed Models Analysis|||Mental Component Scale - 3 months||4.5661|-4.9175|0.9413
72362963|NCT04613362|144237112|SUPERIORITY||Mean Difference (Net)|-2.9597|STANDARD_ERROR_OF_MEAN|2.2549||0.1934|TWO_SIDED|95.0|-7.4526|1.5333|||Mixed Models Analysis|||Mental Component Scale - 6 months||1.5333|-7.4526|0.1934
72362964|NCT04613362|144237113|SUPERIORITY||Mean Difference (Net)|3.0999|STANDARD_ERROR_OF_MEAN|2.1004||0.1442|TWO_SIDED|95.0|-1.0852|7.2849|||Mixed Models Analysis|||3 months||7.2849|-1.0852|0.1442
72362965|NCT04613362|144237113|SUPERIORITY||Mean Difference (Net)|2.0675|STANDARD_ERROR_OF_MEAN|2.036||0.3132|TWO_SIDED|95.0|-1.9892|6.1243|||Mixed Models Analysis|||6 months||6.1243|-1.9892|0.3132
72362966|NCT02218372|144237116|OTHER||adjusted treatment difference|7.5|||||TWO_SIDED|95.0|-7.4|23.9||||||Adjusted difference of CCR at EOT + 2 Days. Adjusted treatment difference of proportions was calculated using a stratified Cochran-Mantel-Haenszel (CMH) method. Newcombe 95% confidence intervals (CIs) presented for adjusted treatment difference.||23.9|-7.4|
72362967|NCT02218372|144237117|OTHER||adjusted treatment difference|16.3|||||TWO_SIDED|95.0|1.8|34.2||||||Adjusted difference of SCR at EOT +9 days. Adjusted treatment difference of proportions was calculated using a stratified CMH method. Newcombe 95% CIs presented for adjusted treatment difference.||34.2|1.8|
72362968|NCT02218372|144237118|OTHER||adjusted treatment difference|21.3|||||TWO_SIDED|95.0|4.5|37.7||||||Adjusted difference of GC at EOT +9 days. Adjusted treatment difference of rates was calculated using a stratified CMH method. Newcombe 95% CIs presented for adjusted treatment difference.||37.7|4.5|
72362969|NCT02218372|144237119|OTHER||adjusted treatment difference|-16.3|||||TWO_SIDED|95.0|-34.2|-1.8||||||Adjusted difference of CDAD recurrence at EOT +9 days. Adjusted treatment difference of proportions was calculated using a stratified CMH method. Newcombe 95% CIs presented for adjusted treatment difference.||-1.8|-34.2|
72368491|NCT02304367|144247135|OTHER|||||||0.067|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline 24-hour urinary phosphorus.||Week 192||||0.067
72362970|NCT02218372|144237120|OTHER||adjusted treatment difference|17.2|||||TWO_SIDED|95.0|1.9|35.6||||||Adjusted difference of SCR at EOT +16 days. Adjusted treatment difference of proportions was calculated using a stratified CMH method. Newcombe 95% CIs presented for adjusted treatment difference.||35.6|1.9|
72362971|NCT02218372|144237121|OTHER||adjusted treatment difference|19.4|||||TWO_SIDED|95.0|2.3|35.9||||||Adjusted difference of GC at EOT +16 days. Adjusted treatment difference of rates was calculated using a stratified CMH method. Newcombe 95% CIs presented for adjusted treatment difference.||35.9|2.3|
72362972|NCT02218372|144237122|OTHER||adjusted treatment difference|-17.2|||||TWO_SIDED|95.0|-35.6|-1.9||||||Adjusted difference of CDAD Recurrence at EOT +16 days. Adjusted treatment difference of proportions was calculated using a stratified CMH method. Newcombe 95% CIs presented for adjusted treatment difference.||-1.9|-35.6|
72362973|NCT02218372|144237123|OTHER||adjusted treatment difference|15.8|||||TWO_SIDED|95.0|-0.5|34.5||||||Adjusted difference of SCR at EOT +23 days. Adjusted treatment difference of proportions was calculated using a stratified CMH method. Newcombe 95% CIs presented for adjusted treatment difference.||34.5|-0.5|
72362974|NCT02218372|144237124|OTHER||adjusted treatment difference|18.8|||||TWO_SIDED|95.0|1.5|35.3||||||Adjusted difference of GC at EOT +23 days. Adjusted treatment difference of rates was calculated using a stratified CMH method. Newcombe 95% CIs presented for adjusted treatment difference.||35.3|1.5|
72362975|NCT02218372|144237125|OTHER||adjusted treatment difference|-15.8|||||TWO_SIDED|95.0|-34.5|0.5||||||Adjusted difference of CDAD Recurrence at EOT +23 days. Adjusted treatment difference of proportions was calculated using a stratified CMH method. Newcombe 95% CIs presented for adjusted treatment difference.||0.5|-34.5|
72362976|NCT02218372|144237126|OTHER||adjusted treatment difference|15.8|||||TWO_SIDED|95.0|-0.5|34.5||||||Adjusted difference of SCR at EOS (EOT +30 days). Adjusted treatment difference of proportions was calculated using a stratified CMH method. Newcombe 95% CIs presented for adjusted treatment difference.||34.5|-0.5|
72362977|NCT02218372|144237127|OTHER||adjusted treatment difference|18.8|||||TWO_SIDED|95.0|1.5|35.3||||||Adjusted difference of GC at EOS (EOT +30 days). Adjusted treatment difference of rates was calculated using a stratified CMH method. Newcombe 95% CIs presented for adjusted treatment difference.||35.3|1.5|
72429379|NCT00479037|144369733|SUPERIORITY_OR_OTHER||Mean Difference (Net)|92.9|||<|0.0001|TWO_SIDED|95.0|63.8|127.1||P-values corresponding to the tests of treatment effect for the primary endpoints were adjusted using the Hochberg procedure.|ANCOVA|||The bone marker values were log-transformed for the primary analysis as they were heavily skewed. Changes in log-transformed bone marker values were analyzed using an analysis of covariance (ANCOVA) with treatment and center as fixed effects and the baseline bone marker value as a covariate. An F-test was used to test the effect of treatment and the least square means were computed to assess the clinical difference between treatment groups.||127.1|63.8|<0.0001
72429380|NCT00479037|144369734|SUPERIORITY_OR_OTHER||Mean Difference (Net)|138.5|||<|0.0001|TWO_SIDED|95.0|94.8|191.8||P-value corresponding to the tests of treatment effect was adjusted using the Hochberg procedure.|ANCOVA|||The bone marker values were log-transformed for the primary analysis as they were heavily skewed. Changes in log-transformed bone marker values were analyzed using an analysis of covariance (ANCOVA) with treatment and center as fixed effects and the baseline bone marker value as a covariate. An F-test was used to test the effect of treatment and the least square means were computed to assess the clinical difference between treatment groups.||191.8|94.8|<0.0001
72429381|NCT01676220|144369788|NON_INFERIORITY_OR_EQUIVALENCE|"Stepwise closed testing approach was used to assess non-inferiority and superiority sequentially:~1. Non-inferiority of HOE901-U300 vs Lantus: Upper bound of two-sided 95% confidence interval (CI) of difference between HOE901-U300 and Lantus on mITT population is \<0.4%.~2. Superiority (only if non-inferiority has been demonstrated): Upper bound of two-sided 95% CI for difference in mean change in HbA1c from baseline to endpoint between HOE901-U300 and Lantus on mITT population is \<0."|Least Squares (LS) Mean Difference|0.04|STANDARD_ERROR_OF_MEAN|0.067|||TWO_SIDED|95.0|-0.09|0.174||||||Analysis was performed using mixed model for repeated measurements (MMRM) with treatment groups, strata of screening HbA1c (\<8.0, \>=8.0%), geographical region (Non-Japan; Japan), visit and visit-by-treatment groups interaction as fixed categorical effects; baseline HbA1c and baseline HbA1c-by-visit interaction as continuous fixed covariates.||0.174|-0.090|
72362978|NCT02218372|144237128|OTHER|Newcombe 95% CIs presented for adjusted treatment difference.|adjusted treatment difference|-15.8|||||TWO_SIDED|95.0|-34.5|0.5||||||Adjusted difference of CDAD recurrence at EOS/EOT +30 days. Adjusted treatment difference of proportions was calculated using a stratified CMH method. Newcombe 95% CIs presented for adjusted treatment difference.||0.5|-34.5|
72362979|NCT02218372|144237129|OTHER|||||||0.579|||||||Log Rank|||Time to resolution of diarrhea.||||0.579
72362980|NCT02218372|144237130|OTHER|||||||0.023|||||||Log Rank|||Time to recurrence of CDAD.||||0.023
72362981|NCT02753283|144237139|SUPERIORITY||Mean Difference (Final Values)|4.8|STANDARD_ERROR_OF_MEAN|1.48||0.007|TWO_SIDED||||||Mixed Models Analysis|Using multiple imputation for missing data||||||.007
72362982|NCT02753283|144237139|SUPERIORITY||Mean Difference (Final Values)|2.7|STANDARD_ERROR_OF_MEAN|1.09||0.018|TWO_SIDED||||||Mixed Models Analysis|Using multiple imputation for missing data||||||.018
72362983|NCT02753283|144237140|SUPERIORITY||Mean Difference (Final Values)|3.99|STANDARD_ERROR_OF_MEAN|1.45||0.014|TWO_SIDED||||||Mixed Models Analysis|Using multiple imputation for missing data||||||.014
72362984|NCT02753283|144237140|SUPERIORITY||Mean Difference (Final Values)|5.16|STANDARD_ERROR_OF_MEAN|1.45||0.002|TWO_SIDED||||||Mixed Models Analysis|Using multiple imputation for missing data||||||.002
72362985|NCT02753283|144237141|SUPERIORITY||Mean Difference (Final Values)|2.54|STANDARD_ERROR_OF_MEAN|1.26||0.06|TWO_SIDED||||||Mixed Models Analysis|Using multiple imputation for missing data||||||.060
72362986|NCT02753283|144237141|SUPERIORITY||Mean Difference (Final Values)|2.45|STANDARD_ERROR_OF_MEAN|1.22||0.055|TWO_SIDED||||||Mixed Models Analysis|Using multiple imputation for missing data||||||.055
72362987|NCT02753283|144237142|SUPERIORITY||Mean Difference (Final Values)|2.21|STANDARD_ERROR_OF_MEAN|1.37||0.112|TWO_SIDED||||||Mixed Models Analysis|Using multiple imputation for missing data||||||.112
72362988|NCT02753283|144237142|SUPERIORITY||Mean Difference (Final Values)|2.46|STANDARD_ERROR_OF_MEAN|1.34||0.07|TWO_SIDED||||||Mixed Models Analysis|Using multiple imputation for missing data||||||.070
72362989|NCT02753283|144237143|SUPERIORITY||Mean Difference (Final Values)|-0.17|STANDARD_ERROR_OF_MEAN|1.39||0.904|TWO_SIDED||||||Mixed Models Analysis|Using multiple imputation for missing data||||||.904
72362990|NCT02753283|144237143|SUPERIORITY||Mean Difference (Final Values)|-1.17|STANDARD_ERROR_OF_MEAN|2.29||0.616|TWO_SIDED||||||Mixed Models Analysis|Using multiple imputation for missing data||||||.616
72362991|NCT02753283|144237144|SUPERIORITY||Mean Difference (Final Values)|-0.16|STANDARD_ERROR_OF_MEAN|0.04|<|0.001|TWO_SIDED||||||Mixed Models Analysis|Using multiple imputation for missing data||||||<.001
72362992|NCT02753283|144237144|SUPERIORITY||Mean Difference (Final Values)|-0.09|STANDARD_ERROR_OF_MEAN|0.03||0.005|TWO_SIDED||||||Mixed Models Analysis|Using multiple imputation for missing data||||||.005
72362993|NCT02753283|144237145|SUPERIORITY||Mean Difference (Final Values)|-26.2|STANDARD_ERROR_OF_MEAN|6.0||0.001|TWO_SIDED||||||Mixed Models Analysis|Using multiple imputation for missing data||||||.001
72362994|NCT02753283|144237145|SUPERIORITY||Mean Difference (Final Values)|-8.2|STANDARD_ERROR_OF_MEAN|3.9||0.038|TWO_SIDED||||||Mixed Models Analysis|Using multiple imputation for missing data||||||.038
72362995|NCT04386291|144237146|SUPERIORITY||Mean Difference (Final Values)|-1.54||||0.071|TWO_SIDED||||||t-test, 1 sided|||||||0.071
72362996|NCT04386291|144237146|SUPERIORITY||Mean Difference (Final Values)|-0.09||||0.46|TWO_SIDED||||||t-test, 1 sided|||||||0.46
72362997|NCT04386291|144237147|SUPERIORITY||Mean Difference (Final Values)|-2.4||||0.01|TWO_SIDED||||||t-test, 1 sided|||||||0.01
72362998|NCT04386291|144237147|SUPERIORITY||Mean Difference (Final Values)|-1.76||||0.04|TWO_SIDED||||||t-test, 1 sided|||||||0.04
72362999|NCT04386291|144237148|SUPERIORITY||Mean Difference (Final Values)|-1.47||||0.08|TWO_SIDED||||||t-test, 1 sided|||||||0.08
72363000|NCT04386291|144237148|SUPERIORITY||Mean Difference (Final Values)|0.12||||0.5|TWO_SIDED||||||t-test, 1 sided|||||||0.5
72429382|NCT01676220|144369789|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.89||||0.4536|TWO_SIDED|95.0|0.66|1.2|||Cochran-Mantel-Haenszel|||A one-sided test (at alpha=0.025) for superiority of HOE901-U300 over Lantus was to be performed in case the non-inferiority of HOE901-U300 vs Lantus for the primary endpoint was demonstrated. Analysis was performed using Cochran-Mantel-Haenszel (CMH) method stratified by randomization strata of screening HbA1c (\<8.0, \>=8.0%), randomization strata of geographical region (Non-Japan; Japan).||1.20|0.66|0.4536
72363001|NCT04386291|144237149|SUPERIORITY||Mean Difference (Final Values)|-0.68||||0.25|TWO_SIDED||||||t-test, 1 sided|||||||0.25
72363002|NCT04386291|144237149|SUPERIORITY||Mean Difference (Final Values)|-1.54||||0.065|TWO_SIDED||||||t-test, 1 sided|||||||0.065
72363003|NCT04386291|144237150|SUPERIORITY||Mean Difference (Final Values)|1.24||||0.88|TWO_SIDED||||||t-test, 1 sided|||||||0.88
72363004|NCT04386291|144237150|SUPERIORITY||Mean Difference (Final Values)|0.56||||0.7|TWO_SIDED||||||t-test, 1 sided|||||||0.7
72363005|NCT04386291|144237151|SUPERIORITY||Mean Difference (Final Values)|-1.84||||0.038|TWO_SIDED||||||t-test, 1 sided|||||||0.038
72363006|NCT04386291|144237151|SUPERIORITY||Mean Difference (Final Values)|-1.59||||0.059|TWO_SIDED||||||t-test, 1 sided|||||||0.059
72363007|NCT04386291|144237152|SUPERIORITY||Median Difference (Final Values)|1.58||||0.9|TWO_SIDED||||||t-test, 1 sided|||Reappraisal subscale analysis||||0.9
72363008|NCT04386291|144237152|SUPERIORITY||Mean Difference (Net)|-0.73||||0.23|TWO_SIDED||||||t-test, 1 sided|||Subpression subscale analysis||||0.23
72363009|NCT04386291|144237152|SUPERIORITY||Mean Difference (Final Values)|0.54||||0.7|TWO_SIDED||||||t-test, 1 sided|||Reappraisal subscale analysis||||0.7
72363010|NCT04386291|144237152|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.5|TWO_SIDED||||||t-test, 1 sided|||Suppression subscale analysis||||0.5
72363011|NCT04386291|144237153|SUPERIORITY||Mean Difference (Final Values)|0.67||||0.5|TWO_SIDED||||||ANOVA|||||||0.5
72363012|NCT04386291|144237154|SUPERIORITY||mean rank difference|79.0||||0.076|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|Mann-Witney was used because assumption of normality of variance was violated||||||0.076
72363013|NCT04386291|144237154|SUPERIORITY||Mean Difference (Final Values)|0.9||||0.8|TWO_SIDED||||||t-test, 1 sided|||||||0.8
72363014|NCT05172128|144237155|OTHER||||||>|0.05|||||||t-test, 2 sided||||Paired t-test comparing baseline value to endpoint value revealed a p-value of 0.80.|||>0.05
72363015|NCT05172128|144237156|OTHER||||||>|0.05|||||||t-test, 2 sided|||||||>0.05
72363016|NCT05172128|144237157|OTHER||||||>|0.05|||||||t-test, 2 sided|||||||>0.05
72363017|NCT05172128|144237158|OTHER||||||>|0.05|||||||t-test, 2 sided|||||||>0.05
72363018|NCT05172128|144237161|OTHER||||||>|0.05|||||||t-test, 2 sided|||||||>0.05
72363019|NCT01921205|144237163|SUPERIORITY||Percent reduction over Placebo|31.72|||=|0.0003|TWO_SIDED|95.0|16.342|44.277|||ANCOVA|Seizure frequency (log transformed) is analyzed using analysis of covariance with terms for treatment, pooled center and Baseline seizure frequency.|Percent reduction over placebo is estimated as 100 x (1-exp\[LSMLacosamide-LSMPlacebo\]). Where LSM is Least Square Mean.|||44.277|16.342|=0.0003
72363020|NCT03199976|144237194|SUPERIORITY||||||<|0.01||||||Bonferroni correction was applied in pairwise analyses.|Wilcoxon (Mann-Whitney)|||||||<0.01
72363021|NCT03199976|144237195|SUPERIORITY|||||||0.595|||||||Chi-squared|||||||0.595
72363022|NCT03199976|144237196|SUPERIORITY||||||<|0.01||||||Bonferroni correction was applied in pairwise analyses.|Wilcoxon (Mann-Whitney)|||||||<0.01
72363023|NCT03199976|144237197|SUPERIORITY||||||<|0.05|||||||Chi-squared|||||||<0.05
72368492|NCT02304367|144247135|OTHER|||||||0.33|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline 24-hour urinary phosphorus.||Week 216||||0.330
72368493|NCT02304367|144247135|SUPERIORITY|||||||0.161|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline 24-hour urinary phosphorus.||Week 240||||0.161
72368494|NCT02304367|144247136|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline TRP.||Week 24||||< 0.001
72368495|NCT02304367|144247136|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline TRP.||Week 48||||< 0.001
72368496|NCT02304367|144247136|OTHER|||||||0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline TRP.||Week 96||||0.001
72368497|NCT02304367|144247136|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline TRP.||Week 144||||< 0.001
72368498|NCT02304367|144247136|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline TRP.||Week 168||||< 0.001
72363024|NCT01780506|144237207|NON_INFERIORITY_OR_EQUIVALENCE|Null hypothesis: the E/C/F/TAF group was ≥ 12% worse than the E/C/F/TDF group with respect to the percentage of participants achieving HIV-1 RNA \< 50 copies/mL at Week 48; alternative hypothesis: the E/C/F/TAF group was \< 12% worse than the E/C/F/TDF group.|Difference in percentages|0.5||||0.78|TWO_SIDED|95.002|-3.0|4.0||P-value was from the Cochran-Mantel-Haenszel (CMH) test stratified by baseline HIV-1 RNA (≤ 100,000 or \> 100,000 copies/mL) and region (US vs ex-US).|Cochran-Mantel-Haenszel||The difference in percentages and its 95.002% confidence interval (CI) were calculated based on the Mantel-Haenszel (MH) proportions adjusted by baseline HIV-1 RNA and region stratum.|||4.0|-3.0|0.78
72363025|NCT00412984|144237235|SUPERIORITY|With an average 2.1 years follow-up and assuming a stroke rate of 1.20 per hundred patient-years, \~18,000 randomized subjects allocated in a 1:1 ratio to apixaban or warfarin group would be needed to achieve the desired power. These calculations assumed an incidence of 1% loss to follow-up. Non-inferiority for the primary efficacy endpoint will be assessed first. If non-inferiority (using a NI margin of 1.38) is demonstrated then, superiority for the primary efficacy endpoint will be tested|Hazard Ratio (HR)|0.79||||0.0114|TWO_SIDED|95.0|0.66|0.95||2-sided P-value for superiority test|Cox Proportional Hazards Model|Model included treatment group as a covariate; stratified by investigative site and prior warfarin/vitamin K antagonist status. (experienced, naïve).|apixaban / warfarin|With 448 subjects with confirmed strokes or systemic emboli, study would have at least 90% power to meet both regulatory definitions of non-inferiority described in the following: (1) the non-inferiority (NI) of apixaban relative to warfarin was demonstrated if the upper bound of the two-sided 95% confidence interval (CI) for relative risk (RR) was less than 1.38; (2) the NI of apixaban relative to warfarin was demonstrated if the upper bound of the two-sided 99% CI for RR was less than 1.44.||.95|.66|0.0114
72368499|NCT02304367|144247136|SUPERIORITY||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline TRP.||Week 192||||< 0.001
72368500|NCT02304367|144247136|SUPERIORITY||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline TRP.||Week 216||||< 0.001
72368501|NCT02304367|144247136|SUPERIORITY||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline TRP.||Week 240||||< 0.001
72368502|NCT02304367|144247137|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline TmP/GFR||Week 24||||< 0.001
72368503|NCT02304367|144247137|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline TmP/GFR||Week 48||||< 0.001
72368504|NCT02304367|144247137|OTHER|||||||0.002|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline TmP/GFR||Week 96||||0.002
72368505|NCT02304367|144247137|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline TmP/GFR||Week 144||||< 0.001
72368506|NCT02304367|144247137|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline TmP/GFR.||Week 168||||< 0.001
72368507|NCT02304367|144247137|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline TmP/GFR.||Week 192||||< 0.001
72368508|NCT02304367|144247137|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline TmP/GFR.||Week 216||||< 0.001
72368509|NCT02304367|144247137|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline TmP/GFR.||Week 240||||< 0.001
72368510|NCT02304367|144247138|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline FEP.||Week 24||||< 0.001
72368511|NCT02304367|144247138|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline FEP.||Week 48||||< 0.001
72368512|NCT02304367|144247138|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline FEP.||Week 96||||< 0.001
72368513|NCT02304367|144247138|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline FEP.||Week 144||||< 0.001
72368514|NCT02304367|144247138|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline FEP.||Week 168||||< 0.001
72368515|NCT02304367|144247138|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline FEP.||Week 192||||< 0.001
72368516|NCT02304367|144247138|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline FEP.||Week 216||||< 0.001
72368517|NCT02304367|144247138|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline FEP.||Week 240||||< 0.001
72368518|NCT02304367|144247139|OTHER|||||||0.878|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline ALP.||Week 24||||0.878
72368519|NCT02304367|144247139|OTHER|||||||0.081|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline ALP.||Week 48||||0.081
72368520|NCT02304367|144247139|OTHER|||||||0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline ALP.||Week 96||||0.001
72368521|NCT02304367|144247139|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline ALP.||Week 144||||< 0.001
72368522|NCT02304367|144247139|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline ALP.||Week 168||||< 0.001
72368523|NCT02304367|144247139|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline ALP.||Week 192||||< 0.001
72363026|NCT00412984|144237237|SUPERIORITY|"4 key objectives were tested using a closed testing procedure. NI for the primary efficacy will be tested 1st. If NI is demonstrated then~1. superiority for the primary efficacy will be tested~2. if superiority for the primary efficacy is~   1. not demonstrated, stop~  2. demonstrated, then superiority for MB will be tested~3. if superiority for MB is~   1. not demonstrated, stop~  2. demonstrated, then superiority for all cause death will be tested All tests will be done at 1-sided α = 0.025"|Hazard Ratio (HR)|0.69|||<|0.0001|TWO_SIDED|95.0|0.6|0.8|||Cox Proportional Hazards Model|Model included treatment group as a covariate; stratified by investigative site and prior warfarin/vitamin K antagonist status.|apixaban / warfarin|||0.80|0.60|<.0001
72363027|NCT00412984|144237239|SUPERIORITY||Hazard Ratio (HR)|0.89||||0.0465|TWO_SIDED|95.0|0.8|1.0|||Cox Proportional Hazards Model|Model included treatment group as a covariate; stratified by investigative site and prior warfarin/vitamin K antagonist status.|apixaban / warfarin|"4 key objectives were tested using a closed testing procedure. NI for the primary efficacy will be tested 1st. If NI is demonstrated then~1. superiority for the primary efficacy will be tested~2. if superiority for the primary efficacy is~   1. not demonstrated, stop~  2. demonstrated, then superiority for MB will be tested~3. if superiority for MB is~   1. not demonstrated, stop~  2. demonstrated, then superiority for all cause death will be tested All tests will be done at 1-sided α = 0.025"||1.00|0.80|0.0465
72363028|NCT00412984|144237240|OTHER||Hazard Ratio (HR)|0.92||||0.422|TWO_SIDED|95.0|0.74|1.13||nominal two-sided p-value was associated with a test of H0: RR=1 vs H1: RR ≠ 1|Cox Proportional Hazards Model||apixaban / warfarin|Ischemic or Unspecified Stroke||1.13|0.74|0.4220
72363029|NCT00412984|144237240|OTHER||Hazard Ratio (HR)|0.51||||0.0006|TWO_SIDED|95.0|0.35|0.75||nominal two-sided p-value was associated with a test of H0: RR=1 vs H1: RR ≠ 1|Cox Proportional Hazards Model||apixaban / warfarin|Hemorrhagic Stroke||0.75|0.35|0.0006
72363030|NCT00412984|144237240|OTHER||Hazard Ratio (HR)|0.87||||0.702|TWO_SIDED|95.0|0.44|1.75||nominal two-sided p-value was associated with a test of H0: RR=1 vs H1: RR ≠ 1|Cox Proportional Hazards Model||apixaban / warfarin|Systemic Embolism||1.75|0.44|0.7020
72363031|NCT00412984|144237240|OTHER||Hazard Ratio (HR)|0.88||||0.372|TWO_SIDED|95.0|0.66|1.17||nominal two-sided p-value was associated with a test of H0: RR=1 vs H1: RR ≠ 1|Cox Proportional Hazards Model||apixaban / warfarin|Myocardial Infarction||1.17|0.66|0.3720
72363032|NCT00412984|144237241|OTHER||Hazard Ratio (HR)|0.77|||<|0.0001|TWO_SIDED|95.0|0.69|0.86||nominal two-sided p-value was associated with a test of H0: RR=1 vs H1: RR ≠ 1|Cox Proportional Hazards Model||apixaban / warfarin|Composite of Stroke / Systemic Embolism / Major Bleeding||0.86|0.69|<.0001
72363033|NCT00412984|144237241|OTHER||Hazard Ratio (HR)|0.89||||0.0192|TWO_SIDED|95.0|0.81|0.98||nominal two-sided p-value was associated with a test of H0: RR=1 vs H1: RR ≠ 1|Cox Proportional Hazards Model||apixaban / warfarin|Composite of Stroke / Systemic Embolism / All-Cause Death||0.98|0.81|0.0192
72363034|NCT00412984|144237241|OTHER||Hazard Ratio (HR)|0.85||||0.0002|TWO_SIDED|95.0|0.78|0.92||nominal two-sided p-value was associated with a test of H0: RR=1 vs H1: RR ≠ 1|Cox Proportional Hazards Model||apixaban / warfarin|Composite of Stroke / Systemic Embolism / Major Bleeding / All-Cause Death||0.92|0.78|0.0002
72363035|NCT00412984|144237241|OTHER||Hazard Ratio (HR)|0.88||||0.0107|TWO_SIDED|95.0|0.8|0.97||nominal two-sided p-value was associated with a test of H0: RR=1 vs H1: RR ≠ 1|Cox Proportional Hazards Model||apixaban / warfarin|Composite of Stroke / Systemic Embolism / MI / All-Cause Death||0.97|0.80|0.0107
72363036|NCT00412984|144237241|OTHER||Hazard Ratio (HR)|0.9||||0.0432|TWO_SIDED|95.0|0.82|1.0||nominal two-sided p-value was associated with a test of H0: RR=1 vs H1: RR ≠ 1|Cox Proportional Hazards Model||apixaban / warfarin|Composite of Ischemic or Unspecified Stroke / All-Cause Death||1.00|0.82|0.0432
72363037|NCT00412984|144237241|OTHER||Hazard Ratio (HR)|0.88||||0.0167|TWO_SIDED|95.0|0.79|0.98||nominal two-sided p-value was associated with a test of H0: RR=1 vs H1: RR ≠ 1|Cox Proportional Hazards Model||apixaban / warfarin|Composite of Hemorrhagic Stroke / All-Cause Death||0.98|0.79|0.0167
72363038|NCT00412984|144237241|OTHER||Hazard Ratio (HR)|0.89||||0.0464|TWO_SIDED|95.0|0.8|1.0||nominal two-sided p-value was associated with a test of H0: RR=1 vs H1: RR ≠ 1|Cox Proportional Hazards Model||apixaban / warfarin|Composite of Systemic Embolism / All-Cause Death||1.00|0.80|0.0464
72363039|NCT00412984|144237241|OTHER||Hazard Ratio (HR)|0.89||||0.0253|TWO_SIDED|95.0|0.8|0.99||nominal two-sided p-value was associated with a test of H0: RR=1 vs H1: RR ≠ 1|Cox Proportional Hazards Model||apixaban / warfarin|Composite of Myocardial Infarction / All-Cause Death||0.99|0.80|0.0253
72363040|NCT00412984|144237243|OTHER||Hazard Ratio (HR)|0.8||||0.0098|TWO_SIDED|95.0|0.67|0.95||nominal two-sided p-value was associated with a test of H0: RR=1 vs H1: RR ≠ 1|Cox Proportional Hazards Model||apixaban / warfarin|Composite Stroke/Systemic Embolism/Major Bleeding in Warfarin/Vitamin K Antagonist (VKA) Naive Participants||0.95|0.67|0.0098
72363041|NCT00412984|144237246|OTHER||Hazard Ratio (HR)|0.68|||<|0.0001|TWO_SIDED|95.0|0.61|0.75||nominal two-sided p-value was associated with a test of H0: RR=1 vs H1: RR ≠ 1|Cox Proportional Hazard Model||apixaban / warfarin|||0.75|0.61|<.0001
72363042|NCT00412984|144237248|OTHER||Hazard Ratio (HR)|0.71|||<|0.0001|TWO_SIDED|95.0|0.68|0.75||nominal two-sided p-value was associated with a test of H0: RR=1 vs H1: RR ≠ 1|Cox Proportional Hazard Model||apixaban / warfarin|||0.75|0.68|<.0001
72363043|NCT00412984|144237249|OTHER||Hazard Ratio (HR)|0.46|||<|0.0001|TWO_SIDED|95.0|0.35|0.6||nominal two-sided p-value was associated with a test of H0: RR=1 vs H1: RR ≠ 1|Cox Proportional Hazard Model||apixaban / warfarin|Severe GUSTO bleeding events||0.60|0.35|<.0001
72363044|NCT00412984|144237249|OTHER||Hazard Ratio (HR)|0.6|||<|0.0001|TWO_SIDED|95.0|0.5|0.71||nominal two-sided p-value was associated with a test of H0: RR=1 vs H1: RR ≠ 1|Cox Proportional Hazard Model||apixaban / warfarin|Severe or Moderate GUSTO bleeding events||0.71|0.50|<.0001
72363045|NCT00412984|144237250|OTHER||Hazard Ratio (HR)|0.57|||<|0.0001|TWO_SIDED|95.0|0.46|0.7||nominal two-sided p-value was associated with a test of H0: RR=1 vs H1: RR ≠ 1|Cox Proportional Hazard Model||apixaban / warfarin|Major TIMI bleeding event||0.70|0.46|<.0001
72363046|NCT00412984|144237250|OTHER||Hazard Ratio (HR)|0.63|||<|0.0001|TWO_SIDED|95.0|0.54|0.75|||Cox Proportional Hazard Model||apixaban / warfarin|Major or Minor TIMI bleeding criteria||0.75|0.54|<.0001
72363047|NCT00412984|144237252|OTHER||Hazard Ratio (HR)|0.74|||<|0.0001|TWO_SIDED|95.0|0.65|0.83||nominal two-sided p-value was associated with a test of H0: RR=1 vs H1: RR ≠ 1|Cox Proportional Hazard Model||apixaban / warfarin|||0.83|0.65|<.0001
72368524|NCT02304367|144247139|OTHER|||||||0.055|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline ALP.||Week 216||||0.055
72363048|NCT05179785|144237273|OTHER|||||||0.2938909|||||||t-test, 2 sided|||"Paired t-test examining delayed choices on the delay discounting task (post versus pre).~One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task"||||0.29389090
72363049|NCT05179785|144237273|OTHER|||||||0.97863544|||||||t-test, 2 sided|||"Paired t-test examining immediate choices on the delay discounting task (post versus pre).~One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task"||||0.97863544
72363050|NCT05179785|144237273|OTHER|||||||0.60236264|||||||t-test, 2 sided|||"Paired t-test examining delayed choices on the delay discounting task (post versus pre).~One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task"||||0.60236264
72363051|NCT05179785|144237273|OTHER|||||||0.35845126|||||||t-test, 2 sided|||"Paired t-test examining immediate choices on the delay discounting task (post versus pre).~One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task"||||0.35845126
72363052|NCT05179785|144237273|OTHER|||||||0.91766025|||||||t-test, 2 sided|||"Paired t-test examining delayed choices on the delay discounting task (post versus pre).~One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task"||||0.91766025
72363053|NCT05179785|144237273|OTHER|||||||0.09605169|||||||t-test, 2 sided|||"Paired t-test examining immediate choices on the delayed discounting task (post versus pre).~One participant was excluded from the EEG data analysis due to lack of immediate choices on the delayed discounting task"||||0.09605169
72363054|NCT05179785|144237274|OTHER|||||||0.50030946|||||||t-test, 2 sided|||Paired t-test examining delayed choices on the delay discounting task (post versus pre). One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task||||0.50030946
72363055|NCT05179785|144237274|OTHER|||||||0.3751738|||||||t-test, 2 sided|||Paired t-test examining immediate choices on the delay discounting task (post versus pre). One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task||||0.37517380
72363056|NCT05179785|144237274|OTHER|||||||0.47876971|||||||t-test, 2 sided|||Paired t-test examining delayed choices on the delay discounting task (post versus pre). One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task||||0.47876971
72363057|NCT05179785|144237274|OTHER|||||||0.21798816|||||||t-test, 2 sided|||Paired t-test examining immediate choices on the delay discounting task (post versus pre). One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task||||0.21798816
72363058|NCT05179785|144237274|OTHER|||||||0.47876971|||||||t-test, 2 sided|||Paired t-test examining delayed choices on the delay discounting task (post versus pre). One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task||||0.47876971
72363059|NCT05179785|144237274|OTHER|||||||0.21798816|||||||t-test, 2 sided|||Paired t-test examining immediate choices on the delay discounting task (post versus pre). One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task||||0.21798816
72363060|NCT05179785|144237275|OTHER|||||||0.75298499|||||||t-test, 2 sided|||Paired t-test examining delayed choices on the delay discounting task (post versus pre). One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task||||0.75298499
72363061|NCT05179785|144237275|OTHER|||||||0.16043787|||||||t-test, 2 sided|||Paired t-test examining immediate choices on the delay discounting task (post versus pre). One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task||||0.16043787
72363062|NCT05179785|144237275|OTHER|||||||0.67902693|||||||t-test, 2 sided|||Paired t-test examining delayed choices on the delay discounting task (post versus pre). One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task||||0.67902693
72363063|NCT05179785|144237275|OTHER|||||||0.33832977|||||||t-test, 2 sided|||Paired t-test examining immediate choices on the delay discounting task (post versus pre). One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task||||0.33832977
72363064|NCT05179785|144237275|OTHER|||||||0.67902693|||||||t-test, 2 sided|||Paired t-test examining delayed choices on the delay discounting task (post versus pre). One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task||||0.67902693
72363065|NCT05179785|144237275|OTHER|||||||0.33832977|||||||t-test, 2 sided|||Paired t-test examining immediate choices on the delay discounting task (post versus pre). One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task||||0.33832977
72363066|NCT05179785|144237276|OTHER|||||||0.73357221|||||||t-test, 2 sided|||"Paired t-test examining delayed choices on the delay discounting task (post versus pre).~One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task"||||0.73357221
72363067|NCT05179785|144237276|OTHER|||||||0.43954526|||||||t-test, 2 sided|||"Paired t-test examining immediate choices on the delay discounting task (post versus pre).~One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task"||||0.43954526
72363068|NCT05179785|144237276|OTHER|||||||0.4419898|||||||t-test, 2 sided|||"Paired t-test examining delayed choices on the delay discounting task (post versus pre).~One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task"||||0.44198980
72363069|NCT05179785|144237276|OTHER|||||||0.39565784|||||||t-test, 2 sided|||"Paired t-test examining immediate choices on the delay discounting task (post versus pre).~One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task"||||0.39565784
72363070|NCT05179785|144237276|OTHER|||||||0.35602382|||||||t-test, 2 sided|||"Paired t-test examining delayed choices on the delay discounting task (post versus pre).~One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task"||||0.35602382
72363071|NCT05179785|144237276|OTHER|||||||0.30499144|||||||t-test, 2 sided|||"Paired t-test examining immediate choices on the delay discounting task (post versus pre).~One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task"||||0.30499144
72363072|NCT05179785|144237277|OTHER|||||||0.81601415|||||||t-test, 2 sided|||Paired t-test examining delayed choices on the delay discounting task (post versus pre). One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task||||0.81601415
72363073|NCT05179785|144237277|OTHER|||||||0.20563452|||||||t-test, 2 sided|||Paired t-test examining immediate choices on the delay discounting task (post versus pre). One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task||||0.20563452
72363074|NCT05179785|144237277|OTHER|||||||0.21947623|||||||t-test, 2 sided|||Paired t-test examining delayed choices on the delay discounting task (post versus pre). One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task||||0.21947623
72363075|NCT05179785|144237277|OTHER|||||||0.45535329|||||||t-test, 2 sided|||Paired t-test examining immediate choices on the delay discounting task (post versus pre). One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task||||0.45535329
72363076|NCT05179785|144237277|OTHER|||||||0.21947623|||||||t-test, 2 sided|||Paired t-test examining delayed choices on the delay discounting task (post versus pre). One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task||||0.21947623
72363077|NCT05179785|144237277|OTHER|||||||0.45535329|||||||t-test, 2 sided|||Paired t-test examining immediate choices on the delay discounting task (post versus pre). One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task||||0.45535329
72363078|NCT05179785|144237278|OTHER|||||||0.83462055|||||||t-test, 2 sided|||"Paired t-test examining delayed choices on the delay discounting task (post versus pre).~One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task"||||0.83462055
72363079|NCT05179785|144237278|OTHER|||||||0.21582586|||||||t-test, 2 sided|||"Paired t-test examining immediate choices on the delay discounting task (post versus pre).~One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task"||||0.21582586
72363080|NCT05179785|144237278|OTHER|||||||0.59574875|||||||t-test, 2 sided|||"Paired t-test examining delayed choices on the delay discounting task (post versus pre).~One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task"||||0.59574875
72363081|NCT05179785|144237278|OTHER|||||||0.75948776|||||||t-test, 2 sided|||"Paired t-test examining immediate choices on the delay discounting task (post versus pre).~One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task"||||0.75948776
72363082|NCT05179785|144237278|OTHER|||||||0.7238414|||||||t-test, 2 sided|||"Paired t-test examining delayed choices on the delay discounting task (post versus pre).~One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task"||||0.72384140
72363083|NCT05179785|144237278|OTHER|||||||0.00477281|||||||t-test, 2 sided|||"Paired t-test examining immediate choices on the delay discounting task (post versus pre).~One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task"||||0.00477281
72363084|NCT05179785|144237279|OTHER|||||||0.20047055|||||||t-test, 2 sided|||Paired t-test examining delayed choices on the delay discounting task (post versus pre). One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task||||0.20047055
72363085|NCT05179785|144237279|OTHER|||||||0.77922802|||||||t-test, 2 sided|||Paired t-test examining immediate choices on the delay discounting task (post versus pre). One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task||||0.77922802
72363086|NCT05179785|144237279|OTHER|||||||0.29196708|||||||t-test, 2 sided|||Paired t-test examining delayed choices on the delay discounting task (post versus pre). One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task||||0.29196708
72363087|NCT05179785|144237279|OTHER|||||||0.05605962|||||||t-test, 2 sided|||Paired t-test examining immediate choices on the delay discounting task (post versus pre). One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task||||0.05605962
72363088|NCT05179785|144237279|OTHER|||||||0.57368284|||||||t-test, 2 sided|||Paired t-test examining delayed choices on the delay discounting task (post versus pre). One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task||||0.57368284
72363089|NCT05179785|144237279|OTHER|||||||0.56397238|||||||t-test, 2 sided|||Paired t-test examining immediate choices on the delay discounting task (post versus pre). One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task||||0.56397238
72363090|NCT05179785|144237280|OTHER|||||||0.86107891|||||||t-test, 2 sided|||Paired t-test examining delayed choices on the delay discounting task (post versus pre) (dorsal anterior cingulate cortex). One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task||||0.86107891
72363091|NCT05179785|144237280|OTHER|||||||0.62228799|||||||t-test, 2 sided|||Paired t-test examining immediate choices on the delay discounting task (post versus pre) (dorsal anterior cingulate cortex). One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task||||0.62228799
72363092|NCT05179785|144237280|OTHER|||||||0.79477883|||||||t-test, 2 sided|||Paired t-test examining delayed choices on the delay discounting task (post versus pre) (dorsal anterior cingulate cortex). One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task||||0.79477883
72363093|NCT05179785|144237280|OTHER|||||||0.12634435|||||||t-test, 2 sided|||Paired t-test examining immediate choices on the delay discounting task (post versus pre) (dorsal anterior cingulate cortex). One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task||||0.12634435
72363094|NCT05179785|144237280|OTHER|||||||0.79477883|||||||t-test, 2 sided|||Paired t-test examining delayed choices on the delay discounting task (post versus pre) (dorsal anterior cingulate cortex). One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task||||0.79477883
72363095|NCT05179785|144237280|OTHER|||||||0.12634435|||||||t-test, 2 sided|||Paired t-test examining immediate choices on the delay discounting task (post versus pre) (dorsal anterior cingulate cortex). One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task||||0.12634435
72429383|NCT01676220|144369790|SUPERIORITY_OR_OTHER||LS Mean Difference|0.17|STANDARD_ERROR_OF_MEAN|0.224|||TWO_SIDED|95.0|-0.275|0.605||||||Change in pre-injection SMPG was analyzed using MMRM model with treatment groups, strata of screening HbA1c (\<8.0, \>=8.0%), geographical region (Non-Japan; Japan), visit and visit-by-treatment groups interaction as fixed categorical effects; baseline preinjection SMPG value and baseline preinjection SMPG value-by-visit interaction as continuous fixed covariates.||0.605|-0.275|
72363096|NCT05179785|144237280|OTHER|||||||0.62461968|||||||t-test, 2 sided|||Paired t-test examining delayed choices on the delay discounting task (post versus pre) (posterior parietal cortex). One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task||||0.62461968
72363097|NCT05179785|144237280|OTHER|||||||0.51324793|||||||t-test, 2 sided|||Paired t-test examining immediate choices on the delay discounting task (post versus pre) (posterior parietal cortex). One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task||||0.51324793
72363098|NCT05179785|144237280|OTHER|||||||0.60543603|||||||t-test, 2 sided|||Paired t-test examining delayed choices on the delay discounting task (post versus pre) (posterior parietal cortex). One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task||||0.60543603
72363099|NCT05179785|144237280|OTHER|||||||0.75565448|||||||t-test, 2 sided|||Paired t-test examining immediate choices on the delay discounting task (post versus pre) (posterior parietal cortex). One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task||||0.75565448
72363100|NCT05179785|144237280|OTHER|||||||0.60543603|||||||t-test, 2 sided|||Paired t-test examining delayed choices on the delay discounting task (post versus pre) (posterior parietal cortex). One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task||||0.60543603
72363101|NCT05179785|144237280|OTHER|||||||0.75565448|||||||t-test, 2 sided|||Paired t-test examining immediate choices on the delay discounting task (post versus pre) (posterior parietal cortex). One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task||||0.75565448
72363102|NCT05179785|144237281|OTHER|||||||0.09266386|||||||t-test, 2 sided|||Paired t-test examining delayed choices on the delay discounting task (post versus pre). One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task||||0.09266386
72363103|NCT05179785|144237281|OTHER|||||||0.53980185|||||||t-test, 2 sided|||Paired t-test examining immediate choices on the delay discounting task (post versus pre). One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task||||0.53980185
72363104|NCT05179785|144237281|OTHER|||||||0.30223686|||||||t-test, 2 sided|||Paired t-test examining delayed choices on the delay discounting task (post versus pre). One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task||||0.30223686
72363105|NCT05179785|144237281|OTHER|||||||0.39166649|||||||t-test, 2 sided|||Paired t-test examining immediate choices on the delay discounting task (post versus pre). One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task||||0.39166649
72363106|NCT05179785|144237281|OTHER|||||||0.30223686|||||||t-test, 2 sided|||Paired t-test examining delayed choices on the delay discounting task (post versus pre). One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task||||0.30223686
72363107|NCT05179785|144237281|OTHER|||||||0.39166649|||||||t-test, 2 sided|||Paired t-test examining immediate choices on the delay discounting task (post versus pre). One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task||||0.39166649
72363108|NCT05179785|144237282|OTHER|||||||0.0265|||||||t-test, 2 sided|||Paired t-test (post versus pre)||||0.0265
72363109|NCT05179785|144237282|OTHER|||||||0.1053|||||||t-test, 2 sided|||Paired t-test (post versus pre)||||0.1053
72363110|NCT05179785|144237282|OTHER|||||||0.0033|||||||t-test, 2 sided|||Paired t-test (post versus pre)||||0.0033
72363111|NCT05966142|144237283|SUPERIORITY||Mean Difference (Final Values)|0.16||||0.5913|TWO_SIDED|95.0|-0.42|0.74|||t-test, 2 sided|||||0.74|-0.42|0.5913
72363112|NCT05966142|144237284|SUPERIORITY|||||||0.6803|||||||t-test, 2 sided|||||||0.6803
72363113|NCT05966142|144237285|SUPERIORITY|||||||0.1228|||||||Chi-squared|||||||0.1228
72363114|NCT05966142|144237286|SUPERIORITY||Mean Difference (Final Values)|-0.4||||0.5252|TWO_SIDED|95.0|-1.7|0.9|||t-test, 2 sided|||||0.9|-1.7|0.5252
72363115|NCT05966142|144237287|SUPERIORITY|||||||0.9657|||||||Chi-squared|||||||0.9657
72363116|NCT04852302|144237292|EQUIVALENCE|We evaluated the same group to determine whether their reported depression was the same, worse, or better at 6-months compared to baseline.|Mean Difference (Net)|-1.81|STANDARD_DEVIATION|4.81||0.168|TWO_SIDED|95.0|-4.47|0.86||The a priori threshold for statistical significance was \< 0.05. We did not adjust for multiple comparisons as this was exploratory.|paired sample t-Test, 2-sided|||Null hypothesis was that the mean difference between the paired observations is zero.||0.86|-4.47|0.168
72363117|NCT04852302|144237293|EQUIVALENCE|We evaluated the same group to determine whether their reported depression was the same, worse, or better at 3-months compared to baseline.|Mean Difference (Net)|-0.3|STANDARD_DEVIATION|3.59||0.752|TWO_SIDED|95.0|-2.29|1.69||The a priori threshold for statistical significance was \< 0.05. We did not adjust for multiple comparisons as this was exploratory.|paired sample t-Test, 2-sided|||||1.69|-2.29|0.752
72363118|NCT04852302|144237294|EQUIVALENCE|We evaluated the same group to determine whether their reported anxiety via the Death and Dying Distress Scale was the same, worse, or better at 3-months compared to baseline.|Mean Difference (Net)|-4.67|STANDARD_DEVIATION|16.26||0.285|TWO_SIDED|95.0|-13.67|4.34||The a priori threshold for statistical significance was \< 0.05. We did not adjust for multiple comparisons as this was exploratory.|paired sample t-Test, 2-sided|||||4.34|-13.67|0.285
72363119|NCT04852302|144237294|EQUIVALENCE|We evaluated the same group to determine whether their reported anxiety via the Death and Dying Distress Scale was the same, worse, or better at 6-months compared to baseline.|Mean Difference (Net)|-2.2|STANDARD_DEVIATION|17.22||0.628|TWO_SIDED|95.0|-11.74|7.34||The a priori threshold for statistical significance was \< 0.05. We did not adjust for multiple comparisons as this was exploratory.|paired sample t-Test, 2-sided|||||7.34|-11.74|0.628
72363120|NCT04531176|144237331|NON_INFERIORITY|The results of non-inferiority test results are between pairwise groups. Non-inferiority was tested at the 0.05 level at 1 year and performed pairwise with Bonferroni adjusted significance levels for each paired comparison.||||||0.004||||||The non-inferiority regions were set to be 1% for weight loss change. When both primary endpoints are non-inferior, superiority testing at the 0.025 overall error level with Bonferroni adjustment for each endpoint at 1 year was then performed.|t-test, 1 sided|||||||0.004
72429384|NCT01767129|144369843|SUPERIORITY||Mean Difference (Final Values)|-83.4||||0.1907|TWO_SIDED|95.0|-215.02|48.23|||ANOVA|The standard analysis of variance (ANOVA) model for a 2-period crossover trial was used. Factors in the model were participant, treatment, and period.|The least squares (LS) mean difference was calculated as the AVP-923-45 LS mean minus the placebo LS mean.|||48.23|-215.02|0.1907
72429385|NCT01767129|144369844|SUPERIORITY||Median Difference (Final Values)|-18.9||||0.388|TWO_SIDED|95.0|-65.28|27.42|||ANOVA|The standard ANOVA model for a 2-period crossover trial was used. Factors in the model were participant, treatment, and period.|The LS mean difference was calculated as the AVP-923-45 LS mean minus the placebo LS mean.|||27.42|-65.28|0.3880
72429386|NCT01767129|144369845|SUPERIORITY||Mean Difference (Final Values)|171.9||||0.7574|TWO_SIDED|95.0|-1022.79|1366.64|||ANOVA|The standard ANOVA model for a 2-period crossover trial was used. Factors in the model were participant, treatment, and period.|The LS mean difference was calculated as the AVP-923-45 LS mean minus the placebo LS mean.|||1366.64|-1022.79|0.7574
72429387|NCT01767129|144369846|SUPERIORITY||Mean Difference (Final Values)|48.8||||0.4203|TWO_SIDED|95.0|-80.63|178.3|||ANOVA|The standard ANOVA model for a 2-period crossover trial was used. Factors in the model were participant, treatment, and period.|The LS mean difference was calculated as the AVP-923-45 LS mean minus the placebo LS mean.|||178.30|-80.63|0.4203
72429388|NCT01767129|144369847|SUPERIORITY||Mean Difference (Final Values)|-1.1||||0.1067|TWO_SIDED|95.0|-2.41|0.27|||ANOVA|Change from Day 1 values were compared using ANOVA for a 2-period crossover trial. Factors in the model were participant, treatment, and period.|The LS mean difference was calculated as the AVP-923-45 LS mean minus the placebo LS mean.|Part I||0.27|-2.41|0.1067
72429389|NCT01767129|144369847|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.865|TWO_SIDED|95.0|-2.64|3.09|||ANOVA|Change from Day 1 values were compared using ANOVA for a 2-period crossover trial. Factors in the model were participant, treatment, and period.|The LS mean difference was calculated as the AVP-923-45 LS mean minus the placebo LS mean.|Part II||3.09|-2.64|0.8650
72429390|NCT01767129|144369847|SUPERIORITY||Mean Difference (Final Values)|-2.3||||0.0745|TWO_SIDED|95.0|-4.94|0.27|||ANOVA|Change from Day 1 values were compared using ANOVA for a 2-period crossover trial. Factors in the model were participant, treatment, and period.|The LS mean difference was calculated as the AVP-923-45 LS mean minus the placebo LS mean.|Part IV||0.27|-4.94|0.0745
72429391|NCT01767129|144369848|SUPERIORITY||Mean Difference (Final Values)|-3.9||||0.0625|TWO_SIDED|95.0|-8.1|0.24|||ANOVA|Change from Day 1 values were compared using ANOVA for a 2-period crossover trial. Factors in the model were participant, treatment, and period.|The LS mean difference was calculated as the AVP-923-45 LS mean minus the placebo LS mean.|Part 1||0.24|-8.10|0.0625
72429392|NCT01767129|144369848|SUPERIORITY||Mean Difference (Final Values)|-1.3||||0.2474|TWO_SIDED|95.0|-3.74|1.07|||ANOVA|Change from Day 1 values were compared using ANOVA for a 2-period crossover trial. Factors in the model were participant, treatment, and period.|The LS mean difference was calculated as the AVP-923-45 LS mean minus the placebo LS mean.|Part 2||1.07|-3.74|0.2474
72429393|NCT01767129|144369849|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.9764|TWO_SIDED|95.0|-3.1|3.01|||ANOVA|Change from Day 1 values were compared using ANOVA for a 2-period crossover trial. Factors in the model were participant, treatment, and period.|The LS mean difference was calculated as the AVP-923-45 LS mean minus the placebo LS mean.|||3.01|-3.10|0.9764
72429394|NCT01767129|144369850|SUPERIORITY||Mean Difference (Final Values)|-1.8||||0.6359|TWO_SIDED|95.0|-9.94|6.36|||ANOVA|Change from Baseline values were compared using ANOVA for a 2-period crossover trial. Factors in the model were participant, treatment, and period.|The LS mean difference was calculated as the AVP-923-45 LS mean minus the placebo LS mean.|Mobility||6.36|-9.94|0.6359
72429395|NCT01767129|144369850|SUPERIORITY||Mean Difference (Final Values)|-8.5||||0.0167|TWO_SIDED|95.0|-15.2|-1.87|||ANOVA|Change from Baseline values were compared using ANOVA for a 2-period crossover trial. Factors in the model were participant, treatment, and period.|The LS mean difference was calculated as the AVP-923-45 LS mean minus the placebo LS mean.|Activities of Daily Living||-1.87|-15.20|0.0167
72429396|NCT01767129|144369850|SUPERIORITY||Mean Difference (Final Values)|-7.5||||0.0959|TWO_SIDED|95.0|-16.54|1.56|||ANOVA|Change from Baseline values were compared using ANOVA for a 2-period crossover trial. Factors in the model were participant, treatment, and period|The LS mean difference was calculated as the AVP-923-45 LS mean minus the placebo LS mean.|Emotional Well Being||1.56|-16.54|0.0959
72429397|NCT01767129|144369850|SUPERIORITY||Mean Difference (Final Values)|-3.9||||0.5108|TWO_SIDED|95.0|-16.72|8.83|||ANOVA|Change from Baseline values were compared using ANOVA for a 2-period crossover trial. Factors in the model were participant, treatment, and period|The LS mean difference was calculated as the AVP-923-45 LS mean minus the placebo LS mean.|Stigma||8.83|-16.72|0.5108
72429398|NCT01767129|144369850|SUPERIORITY||Mean Difference (Final Values)|-9.8||||0.0806|TWO_SIDED|95.0|-21.06|1.42|||ANOVA|Change from Baseline values were compared using ANOVA for a 2-period crossover trial. Factors in the model were participant, treatment, and period.|The LS mean difference was calculated as the AVP-923-45 LS mean minus the placebo LS mean.|Social support||1.42|-21.06|0.0806
72429399|NCT01767129|144369850|SUPERIORITY||Mean Difference (Final Values)|-4.3||||0.4205|TWO_SIDED|95.0|-15.66|7.03|||ANOVA|Change from Baseline values were compared using ANOVA for a 2-period crossover trial. Factors in the model were participant, treatment, and period.|The LS mean difference was calculated as the AVP-923-45 LS mean minus the placebo LS mean.|Cognitive impairment (Cognitions)||7.03|-15.66|0.4205
72429400|NCT01767129|144369850|SUPERIORITY||Mean Difference (Final Values)|-6.1||||0.1065|TWO_SIDED|95.0|-13.63|1.53|||ANOVA|Change from Baseline values were compared using ANOVA for a 2-period crossover trial. Factors in the model were participant, treatment, and period.|The LS mean difference was calculated as the AVP-923-45 LS mean minus the placebo LS mean.|Communication||1.53|-13.63|0.1065
72429401|NCT01767129|144369850|SUPERIORITY||Mean Difference (Final Values)|-5.2||||0.4456|TWO_SIDED|95.0|-19.51|9.19|||ANOVA|Change from Baseline values were compared using ANOVA for a 2-period crossover trial. Factors in the model were participant, treatment, and period.|The LS mean difference was calculated as the AVP-923-45 LS mean minus the placebo LS mean.|Bodily discomfort||9.19|-19.51|0.4456
72429402|NCT01767129|144369851|SUPERIORITY||Mean Difference (Final Values)|-6.4||||0.0233|TWO_SIDED|95.0|-11.72|-1.07|||ANOVA|Change from Baseline values were compared using ANOVA for a 2-period crossover trial. Factors in the model were participant, treatment, and period.|The LS mean difference was calculated as the AVP-923-45 LS mean minus the placebo LS mean.|||-1.07|-11.72|0.0233
72429403|NCT01767129|144369852|SUPERIORITY||Mean Difference (Final Values)|-0.5||||0.193|TWO_SIDED|95.0|-1.39|0.31|||ANOVA|Change from Screening values were compared using ANOVA for a 2-period crossover trial. Factors in the model were participant, treatment, and period.|The LS mean difference was calculated as the AVP-923-45 LS mean minus the placebo LS mean.|||0.31|-1.39|0.1930
72429404|NCT01767129|144369853|SUPERIORITY||Mean Difference (Final Values)|-1.1||||0.0511|TWO_SIDED|95.0|-2.17|0.01|||ANOVA|Change were compared using ANOVA for a 2-period crossover trial. Factors in the model were participant, treatment, and period.|The LS mean difference was calculated as the AVP-923-45 LS mean minus the placebo LS mean.|Dyskinesia||0.01|-2.17|0.0511
72429405|NCT01767129|144369853|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.7745|TWO_SIDED|95.0|-0.7|0.91|||ANOVA|Change were compared using ANOVA for a 2-period crossover trial. Factors in the model were participant, treatment, and period.|The LS mean difference was calculated as the AVP-923-45 LS mean minus the placebo LS mean.|Other symptoms||0.91|-0.70|0.7745
72429406|NCT03389893|144369854|SUPERIORITY||Geometric Mean Ratio|0.033|||<|0.001|TWO_SIDED|95.0|0.008|0.131|||ANCOVA||Dupilumab+Open Label Extension and Follow-Up arm is numerator and Placebo+Open Label Extension and Follow-Up arm is denominator.|||0.131|0.008|<0.001
72429407|NCT03389893|144369855|SUPERIORITY||Geometric Mean Ratio|0.28||||0.019|TWO_SIDED|95.0|0.09|0.8|||Mixed Models Analysis||Dupilumab+Open Label Extension and Follow-Up arm is numerator and Placebo+Open Label Extension and Follow-Up arm is denominator|Day 3||0.80|0.09|0.019
72429408|NCT03389893|144369855|SUPERIORITY||Geometric Mean Ratio|0.37||||0.165|TWO_SIDED|95.0|0.09|1.51|||Mixed Models Analysis||Dupilumab+Open Label Extension and Follow-Up arm is numerator and Placebo+Open Label Extension and Follow-Up arm is denominator|Day 7||1.51|0.09|0.165
72429409|NCT03389893|144369855|SUPERIORITY||Geometric Mean Ratio|0.08|||<|0.001|TWO_SIDED|95.0|0.02|0.27|||Mixed Models Analysis||Dupilumab+Open Label Extension and Follow-Up arm is numerator and Placebo+Open Label Extension and Follow-Up arm is denominator|Day 14||0.27|0.02|<0.001
72429410|NCT03389893|144369855|SUPERIORITY||Geometric Mean Ratio|0.07|||<|0.001|TWO_SIDED|95.0|0.02|0.25|||Mixed Models Analysis||Dupilumab+Open Label Extension and Follow-Up arm is numerator and Placebo+Open Label Extension and Follow-Up arm is denominator|Day 21||0.25|0.02|<0.001
72429411|NCT03389893|144369855|SUPERIORITY||Geometric Mean Ratio|0.16||||0.004|TWO_SIDED|95.0|0.05|0.55|||Mixed Models Analysis||Dupilumab+Open Label Extension and Follow-Up arm is numerator and Placebo+Open Label Extension and Follow-Up arm is denominator|Day 42||0.55|0.05|0.004
72429412|NCT03389893|144369855|SUPERIORITY||Geometric Mean Ratio|0.38||||0.216|TWO_SIDED|95.0|0.08|1.8|||Mixed Models Analysis||Dupilumab+Open Label Extension and Follow-Up arm is numerator and Placebo+Open Label Extension and Follow-Up arm is denominator|Day 77||1.80|0.08|0.216
72429413|NCT03389893|144369855|SUPERIORITY||Geometric Mean Ratio|0.24||||0.071|TWO_SIDED|95.0|0.05|1.13|||Mixed Models Analysis||Dupilumab+Open Label Extension and Follow-Up arm is numerator and Placebo+Open Label Extension and Follow-Up arm is denominator|Day 112||1.13|0.05|0.071
72429414|NCT03389893|144369855|SUPERIORITY||Geometric Mean Ratio|0.34||||0.022|TWO_SIDED|95.0|0.13|0.85|||Mixed Models Analysis||Day 77 is numerator and Day 42 is denominator|Day 77 / Day 42||0.85|0.13|0.022
72429415|NCT03389893|144369855|SUPERIORITY||Geometric Mean Ratio|0.25||||0.015|TWO_SIDED|95.0|0.08|0.76|||Mixed Models Analysis||Day 112 is numerator and Day 42 is denominator|Day 112 / Day 42||0.76|0.08|0.015
72429416|NCT03389893|144369855|SUPERIORITY||Geometric Mean Ratio|0.14|||<|0.001|TWO_SIDED|95.0|0.04|0.41|||Mixed Models Analysis||Day 77 is numerator and Day 42 is denominator|Day 77 / Day 42||0.41|0.04|<0.001
72429417|NCT03389893|144369855|SUPERIORITY||Geometric Mean Ratio|0.16||||0.006|TWO_SIDED|95.0|0.04|0.58|||Mixed Models Analysis||Day 112 is numerator and Day 42 is denominator|Day 112 / Day 42||0.58|0.04|0.006
72429418|NCT03389893|144369856|SUPERIORITY||Geometric Mean Ratio|0.8||||0.724|TWO_SIDED|95.0|0.23|2.82|||Mixed Models Analysis||Dupilumab+Open Label Extension and Follow-Up arm is numerator and Placebo+Open Label Extension and Follow-Up arm is denominator|Day 3||2.82|0.23|0.724
72429419|NCT03389893|144369856|SUPERIORITY||Geometric Mean Ratio|0.27||||0.033|TWO_SIDED|95.0|0.08|0.89|||Mixed Models Analysis||Dupilumab+Open Label Extension and Follow-Up arm is numerator and Placebo+Open Label Extension and Follow-Up arm is denominator|Day 7||0.89|0.08|0.033
72429420|NCT03389893|144369856|SUPERIORITY||Geometric Mean Ratio|0.36||||0.073|TWO_SIDED|95.0|0.12|1.1|||Mixed Models Analysis||Dupilumab+Open Label Extension and Follow-Up arm is numerator and Placebo+Open Label Extension and Follow-Up arm is denominator|Day 14||1.10|0.12|0.073
72429421|NCT03389893|144369856|SUPERIORITY||Geometric Mean Ratio|0.73||||0.579|TWO_SIDED|95.0|0.23|2.29|||Mixed Models Analysis||Dupilumab+Open Label Extension and Follow-Up arm is numerator and Placebo+Open Label Extension and Follow-Up arm is denominator|Day 21||2.29|0.23|0.579
72429422|NCT03389893|144369856|SUPERIORITY||Geometric Mean Ratio|0.17||||0.003|TWO_SIDED|95.0|0.05|0.53|||Mixed Models Analysis||Dupilumab+Open Label Extension and Follow-Up arm is numerator and Placebo+Open Label Extension and Follow-Up arm is denominator|Day 28||0.53|0.05|0.003
72429423|NCT03389893|144369856|SUPERIORITY||Geometric Mean Ratio|0.52||||0.297|TWO_SIDED|95.0|0.15|1.81|||Mixed Models Analysis||Dupilumab+Open Label Extension and Follow-Up arm is numerator and Placebo+Open Label Extension and Follow-Up arm is denominator|Day 42||1.81|0.15|0.297
72429424|NCT03389893|144369856|SUPERIORITY||Geometric Mean Ratio|0.48||||0.326|TWO_SIDED|95.0|0.11|2.12|||Mixed Models Analysis||Dupilumab+Open Label Extension and Follow-Up arm is numerator and Placebo+Open Label Extension and Follow-Up arm is denominator|Day 77||2.12|0.11|0.326
72429425|NCT03389893|144369856|SUPERIORITY||Geometric Mean Ratio|0.52||||0.401|TWO_SIDED|95.0|0.11|2.42|||Mixed Models Analysis||Dupilumab+Open Label Extension and Follow-Up arm is numerator and Placebo+Open Label Extension and Follow-Up arm is denominator|Day 112||2.42|0.11|0.401
72429426|NCT03389893|144369856|SUPERIORITY||Geometric Mean Ratio|0.81||||0.705|TWO_SIDED|95.0|0.28|2.4|||Mixed Models Analysis||Day 77 is numerator and Day 42 is denominator|Day 77 / Day 42||2.40|0.28|0.705
72429427|NCT03389893|144369856|SUPERIORITY||Geometric Mean Ratio|0.72||||0.538|TWO_SIDED|95.0|0.25|2.08|||Mixed Models Analysis||Day 112 is numerator and Day 42 is denominator|Day 112 / Day 42||2.08|0.25|0.538
72429428|NCT03389893|144369856|SUPERIORITY||Geometric Mean Ratio|0.92||||0.892|TWO_SIDED|95.0|0.25|3.34|||Mixed Models Analysis||Day 77 is numerator and Day 42 is denominator|Day 77 / Day 42||3.34|0.25|0.892
72429429|NCT03389893|144369856|SUPERIORITY||Geometric Mean Ratio|0.74||||0.624|TWO_SIDED|95.0|0.21|2.56|||Mixed Models Analysis||Day 112 is numerator and Day 42 is denominator|Day 112 / Day 42||2.56|0.21|0.624
72429430|NCT03389893|144369857|SUPERIORITY||Mean Difference (Final Values)|-9.53||||0.019|TWO_SIDED|95.0|-17.44|-1.63|||Mixed Models Analysis||Dupilumab+Open Label Extension and Follow-Up arm is minuend and Placebo+Open Label Extension and Follow-Up arm is subtrahend. (Minuend - subtrahend=difference.)|Day 3, Lesional||-1.63|-17.44|0.019
72429431|NCT03389893|144369857|SUPERIORITY||Mean Difference (Final Values)|-1.08||||0.837|TWO_SIDED|95.0|-11.47|9.32|||Mixed Models Analysis||Dupilumab+Open Label Extension and Follow-Up arm is minuend and Placebo+Open Label Extension and Follow-Up arm is subtrahend. (Minuend - subtrahend=difference).|Day 7, Lesional||9.32|-11.47|0.837
72429432|NCT03389893|144369857|SUPERIORITY||Mean Difference (Final Values)|0.47||||0.9|TWO_SIDED|95.0|-6.98|7.92|||Mixed Models Analysis||Dupilumab+Open Label Extension and Follow-Up arm is minuend and Placebo+Open Label Extension and Follow-Up arm is subtrahend. (Minuend - subtrahend=difference).|Day 14, Lesional||7.92|-6.98|0.900
72429433|NCT03389893|144369857|SUPERIORITY||Mean Difference (Final Values)|-5.97||||0.13|TWO_SIDED|95.0|-13.76|1.82|||Mixed Models Analysis||Dupilumab+Open Label Extension and Follow-Up arm is minuend and Placebo+Open Label Extension and Follow-Up arm is subtrahend. (Minuend - subtrahend=difference).|Day 21, Lesional||1.82|-13.76|0.130
72429434|NCT03389893|144369857|SUPERIORITY||Mean Difference (Final Values)|-7.1||||0.069|TWO_SIDED|95.0|-14.76|0.56|||Mixed Models Analysis||Dupilumab+Open Label Extension and Follow-Up arm is minuend and Placebo+Open Label Extension and Follow-Up arm is subtrahend. (Minuend - subtrahend=difference).|Day 28, Lesional||0.56|-14.76|0.069
72429435|NCT03389893|144369857|SUPERIORITY||Mean Difference (Final Values)|-7.99||||0.032|TWO_SIDED|95.0|-15.25|-0.73|||Mixed Models Analysis||Dupilumab+Open Label Extension and Follow-Up arm is minuend and Placebo+Open Label Extension and Follow-Up arm is subtrahend. (Minuend - subtrahend=difference).|Day 42, Lesional||-0.73|-15.25|0.032
72429436|NCT03389893|144369857|SUPERIORITY||Mean Difference (Final Values)|-1.05||||0.803|TWO_SIDED|95.0|-9.37|7.28|||Mixed Models Analysis||Dupilumab+Open Label Extension and Follow-Up arm is minuend and Placebo+Open Label Extension and Follow-Up arm is subtrahend. (Minuend - subtrahend=difference).|Day 77, Lesional||7.28|-9.37|0.803
72429437|NCT03389893|144369857|SUPERIORITY||Mean Difference (Final Values)|0.16||||0.972|TWO_SIDED|95.0|-9.02|9.34|||Mixed Models Analysis||Dupilumab+Open Label Extension and Follow-Up arm is minuend and Placebo+Open Label Extension and Follow-Up arm is subtrahend. (Minuend - subtrahend=difference).|Day 112, Lesional||9.34|-9.02|0.972
72429438|NCT03389893|144369857|SUPERIORITY||Mean Difference (Final Values)|-0.27||||0.933|TWO_SIDED|95.0|-6.66|6.12|||Mixed Models Analysis||Day 77 is minuend and Day 42 is subtrahend. (Minuend - subtrahend=difference).|Day 77 / Day 42, Lesional||6.12|-6.66|0.933
72429439|NCT03389893|144369857|SUPERIORITY||Mean Difference (Final Values)|-1.82||||0.563|TWO_SIDED|95.0|-8.1|4.45|||Mixed Models Analysis||Day 112 is minuend and Day 42 is subtrahend. (Minuend - subtrahend=difference).|Day 112 / Day 42, Lesional||4.45|-8.10|0.563
72429440|NCT03389893|144369857|SUPERIORITY||Mean Difference (Final Values)|-7.08||||0.075|TWO_SIDED|95.0|-14.88|0.73|||Mixed Models Analysis||Day 77 is minuend and Day 42 is subtrahend. (Minuend - subtrahend=difference).|Day 77 / Day 42, Lesional||0.73|-14.88|0.075
72429441|NCT03389893|144369857|SUPERIORITY||Mean Difference (Final Values)|-9.84||||0.01|TWO_SIDED|95.0|-17.19|-2.48|||Mixed Models Analysis||Day 112 is minuend and Day 42 is subtrahend. (Minuend - subtrahend=difference).|Day 112 / Day 42, Lesional||-2.48|-17.19|0.010
72429442|NCT03389893|144369857|SUPERIORITY||Median Difference (Final Values)|0.69||||0.805|TWO_SIDED|95.0|-4.86|6.23|||Mixed Models Analysis||Dupilumab+Open Label Extension and Follow-Up arm is minuend and Placebo+Open Label Extension and Follow-Up arm is subtrahend. (Minuend - subtrahend=difference).|Day 3, Non-lesional||6.23|-4.86|0.805
72429443|NCT03389893|144369857|SUPERIORITY||Mean Difference (Final Values)|2.36||||0.329|TWO_SIDED|95.0|-2.44|7.15|||Mixed Models Analysis||Dupilumab+Open Label Extension and Follow-Up arm is minuend and Placebo+Open Label Extension and Follow-Up arm is subtrahend. (Minuend - subtrahend=difference).|Day 7, Non-lesional||7.15|-2.44|0.329
72429444|NCT03389893|144369857|SUPERIORITY||Mean Difference (Final Values)|0.11||||0.97|TWO_SIDED|95.0|-5.39|5.6|||Mixed Models Analysis||Dupilumab+Open Label Extension and Follow-Up arm is minuend and Placebo+Open Label Extension and Follow-Up arm is subtrahend. (Minuend - subtrahend=difference).|Day 14, Non-lesional||5.60|-5.39|0.970
72429445|NCT03389893|144369857|SUPERIORITY||Mean Difference (Final Values)|-3.31||||0.18|TWO_SIDED|95.0|-8.18|1.56|||Mixed Models Analysis||Dupilumab+Open Label Extension and Follow-Up arm is minuend and Placebo+Open Label Extension and Follow-Up arm is subtrahend. (Minuend - subtrahend=difference).|Day 21, Non-lesional||1.56|-8.18|0.180
72429446|NCT03389893|144369857|SUPERIORITY||Mean Difference (Final Values)|-1.76||||0.342|TWO_SIDED|95.0|-5.45|1.94|||Mixed Models Analysis||Dupilumab+Open Label Extension and Follow-Up arm is minuend and Placebo+Open Label Extension and Follow-Up arm is subtrahend. (Minuend - subtrahend=difference).|Day 28, Non-lesional||1.94|-5.45|0.342
72429447|NCT03389893|144369857|SUPERIORITY||Mean Difference (Final Values)|-2.17||||0.234|TWO_SIDED|95.0|-5.81|1.47|||Mixed Models Analysis||Dupilumab+Open Label Extension and Follow-Up arm is minuend and Placebo+Open Label Extension and Follow-Up arm is subtrahend. (Minuend - subtrahend=difference).|Day 42, Non-lesional||1.47|-5.81|0.234
72429448|NCT03389893|144369857|SUPERIORITY||Mean Difference (Final Values)|-2.1||||0.316|TWO_SIDED|95.0|-6.27|2.07|||Mixed Models Analysis||Dupilumab+Open Label Extension and Follow-Up arm is minuend and Placebo+Open Label Extension and Follow-Up arm is subtrahend. (Minuend - subtrahend=difference).|Day 77, Non-lesional||2.07|-6.27|0.316
72429449|NCT03389893|144369857|SUPERIORITY||Mean Difference (Final Values)|-1.89||||0.276|TWO_SIDED|95.0|-5.37|1.59|||Mixed Models Analysis||Dupilumab+Open Label Extension and Follow-Up arm is minuend and Placebo+Open Label Extension and Follow-Up arm is subtrahend. (Minuend - subtrahend=difference).|Day 112, Non-lesional||1.59|-5.37|0.276
72429450|NCT03389893|144369857|SUPERIORITY||Mean Difference (Final Values)|-1.56||||0.237|TWO_SIDED|95.0|-4.19|1.06|||Mixed Models Analysis||Day 77 is minuend and Day 42 is subtrahend. (Minuend - subtrahend=difference).|Day 77 / Day 42, Non-lesional||1.06|-4.19|0.237
72429451|NCT03389893|144369857|SUPERIORITY||Mean Difference (Final Values)|-3.03||||0.01|TWO_SIDED|95.0|-5.3|-0.77|||Mixed Models Analysis||Day 112 is minuend and Day 42 is subtrahend. (Minuend - subtrahend=difference).|Day 112 / Day 42, Non-lesional||-0.77|-5.30|0.010
72429452|NCT03389893|144369857|SUPERIORITY||Mean Difference (Final Values)|-0.46||||0.77|TWO_SIDED|95.0|-3.57|2.65|||Mixed Models Analysis||Day 77 is minuend and Day 42 is subtrahend. (Minuend - subtrahend=difference).|Day 77 / Day 42, Non-lesional||2.65|-3.57|0.770
72429453|NCT03389893|144369857|SUPERIORITY||Mean Difference (Final Values)|-2.14||||0.117|TWO_SIDED|95.0|-4.84|0.56|||Mixed Models Analysis||Day 112 is minuend and Day 42 is subtrahend. (Minuend - subtrahend=difference).|Day 112 / Day 42, Non-lesional||0.56|-4.84|0.117
72429454|NCT03389893|144369858|SUPERIORITY||Mean Difference (Final Values)|85.05||||0.085|TWO_SIDED|95.0|-12.02|182.12|||Mixed Models Analysis||Dupilumab+Open Label Extension and Follow-Up arm is minuend and Placebo+Open Label Extension and Follow-Up arm is subtrahend. (Minuend - subtrahend=difference).|Day 7||182.12|-12.02|0.085
72429455|NCT03389893|144369858|SUPERIORITY||Mean Difference (Final Values)|-21.91||||0.733|TWO_SIDED|95.0|-149.13|105.32|||Mixed Models Analysis||Dupilumab+Open Label Extension and Follow-Up arm is minuend and Placebo+Open Label Extension and Follow-Up arm is subtrahend. (Minuend - subtrahend=difference).|Day 14||105.32|-149.13|0.733
72429456|NCT03389893|144369858|SUPERIORITY||Mean Difference (Final Values)|-82.5||||0.129|TWO_SIDED|95.0|-189.6|24.61|||Mixed Models Analysis||Dupilumab+Open Label Extension and Follow-Up arm is minuend and Placebo+Open Label Extension and Follow-Up arm is subtrahend. (Minuend - subtrahend=difference).|Day 21||24.61|-189.60|0.129
72429457|NCT03389893|144369858|SUPERIORITY||Mean Difference (Final Values)|-92.11||||0.057|TWO_SIDED|95.0|-187.11|2.89|||Mixed Models Analysis||Dupilumab+Open Label Extension and Follow-Up arm is minuend and Placebo+Open Label Extension and Follow-Up arm is subtrahend. (Minuend - subtrahend=difference).|Day 28||2.89|-187.11|0.057
72429458|NCT03389893|144369858|SUPERIORITY||Mean Difference (Final Values)|-48.76||||0.242|TWO_SIDED|95.0|-131.52|34.0|||Mixed Models Analysis||Dupilumab+Open Label Extension and Follow-Up arm is minuend and Placebo+Open Label Extension and Follow-Up arm is subtrahend. (Minuend - subtrahend=difference).|Day 42||34.00|-131.52|0.242
72429459|NCT03389893|144369858|SUPERIORITY||Mean Difference (Final Values)|-54.37||||0.262|TWO_SIDED|95.0|-150.24|41.49|||Mixed Models Analysis||Dupilumab+Open Label Extension and Follow-Up arm is minuend and Placebo+Open Label Extension and Follow-Up arm is subtrahend. (Minuend - subtrahend=difference).|Day 77, Lesional||41.49|-150.24|0.262
72429460|NCT03389893|144369858|SUPERIORITY||Mean Difference (Final Values)|-22.97||||0.546|TWO_SIDED|95.0|-99.79|53.86|||Mixed Models Analysis||Dupilumab+Open Label Extension and Follow-Up arm is minuend and Placebo+Open Label Extension and Follow-Up arm is subtrahend. (Minuend - subtrahend=difference).|Day 112||53.86|-99.79|0.546
72429461|NCT03389893|144369858|SUPERIORITY||Mean Difference (Final Values)|-21.8||||0.503|TWO_SIDED|95.0|-86.34|42.75|||Mixed Models Analysis||Day 77 is minuend and Day 42 is subtrahend. (Minuend - subtrahend=difference).|Day 77 / Day 42||42.75|-86.34|0.503
72429462|NCT03389893|144369858|SUPERIORITY||Mean Difference (Final Values)|-64.0||||0.034|TWO_SIDED|95.0|-123.01|-4.98|||Mixed Models Analysis||Day 112 is minuend and Day 42 is subtrahend. (Minuend - subtrahend=difference).|Day 112 / Day 42||-4.98|-123.01|0.034
72429463|NCT03389893|144369858|SUPERIORITY||Mean Difference (Final Values)|-10.29||||0.789|TWO_SIDED|95.0|-86.63|66.04|||Mixed Models Analysis||Day 77 is minuend and Day 42 is subtrahend. (Minuend - subtrahend=difference).|Day 77 / Day 42||66.04|-86.63|0.789
72429464|NCT03389893|144369858|SUPERIORITY||Mean Difference (Final Values)|-83.9||||0.014|TWO_SIDED|95.0|-149.82|-17.98|||Mixed Models Analysis||Day 112 is minuend and Day 42 is subtrahend. (Minuend - subtrahend=difference).|Day 112 / Day 42||-17.98|-149.82|0.014
72429465|NCT03389893|144369859|SUPERIORITY||Slope|-0.07||||0.86|TWO_SIDED|95.0|-0.92|0.77|||Mixed Models Analysis||Dupilumab+Open Label Extension and Follow-Up arm is minuend and Placebo+Open Label Extension and Follow-Up arm is subtrahend. (Minuend - subtrahend=difference).|Day 7||0.77|-0.92|0.860
72429466|NCT03389893|144369859|SUPERIORITY||Slope|-0.22||||0.488|TWO_SIDED|95.0|-0.85|0.41|||Mixed Models Analysis||Dupilumab+Open Label Extension and Follow-Up arm is minuend and Placebo+Open Label Extension and Follow-Up arm is subtrahend. (Minuend - subtrahend=difference).|Day 14||0.41|-0.85|0.488
72429467|NCT03389893|144369859|SUPERIORITY||Slope|-0.55||||0.144|TWO_SIDED|95.0|-1.3|0.2|||Mixed Models Analysis||Dupilumab+Open Label Extension and Follow-Up arm is minuend and Placebo+Open Label Extension and Follow-Up arm is subtrahend. (Minuend - subtrahend=difference).|Day 21||0.20|-1.30|0.144
72429468|NCT03389893|144369859|SUPERIORITY||Slope|-0.35||||0.279|TWO_SIDED|95.0|-1.0|0.3|||Mixed Models Analysis||Dupilumab+Open Label Extension and Follow-Up arm is minuend and Placebo+Open Label Extension and Follow-Up arm is subtrahend. (Minuend - subtrahend=difference).|Day 28||0.30|-1.00|0.279
72429469|NCT03389893|144369859|SUPERIORITY||Slope|-0.29||||0.461|TWO_SIDED|95.0|-1.09|0.5|||Mixed Models Analysis||Dupilumab+Open Label Extension and Follow-Up arm is minuend and Placebo+Open Label Extension and Follow-Up arm is subtrahend. (Minuend - subtrahend=difference).|Day 42||0.50|-1.09|0.461
72429470|NCT03389893|144369859|SUPERIORITY||Slope|-0.27||||0.345|TWO_SIDED|95.0|-0.84|0.3|||Mixed Models Analysis||Dupilumab+Open Label Extension and Follow-Up arm is minuend and Placebo+Open Label Extension and Follow-Up arm is subtrahend. (Minuend - subtrahend=difference).|Day 77, Lesional||0.30|-0.84|0.345
72429471|NCT03389893|144369859|SUPERIORITY||Slope|-0.27||||0.275|TWO_SIDED|95.0|-0.77|0.23|||Mixed Models Analysis||Dupilumab+Open Label Extension and Follow-Up arm is minuend and Placebo+Open Label Extension and Follow-Up arm is subtrahend. (Minuend - subtrahend=difference).|Day 112||0.23|-0.77|0.275
72429472|NCT01232556|144369881|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.083||||0.708|TWO_SIDED|95.0|0.82|1.44||A one sided 0.025 level testing plan was specified with two interim analyses and final testing level at one-sided 0.023.|Log Rank|From one sided stratified log-rank test.|From stratified Cox proportional hazards model. The stratification factors are are pre-randomization investigator choice, baseline Secondary International Prognostic Index (sIPI), and best response to most recent chemo therapy.|Primary null hypothesis: Equality of survival distributions. Sample size sufficient to have power 0.96 for an experimental/control hazard ratio of 0.6.||1.44|0.82|0.708
72429473|NCT01232556|144369882|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.924||||0.271|TWO_SIDED|95.0|0.72|1.19||An hierarchical testing strategy was specified for OS, PFS and response. PFS could be tested at the 0.023 level if the OS test result were positive. Response could be tested if both the OS and PFS test results were positive.|Log Rank|From one sided stratified log-rank test.|From stratified Cox proportional hazards model. The stratification factors are are pre-randomization investigator choice, baseline sIPI, and best response to most recent chemo therapy.|Second comparison in hierarchical testing strategy was used for power calculation.||1.19|0.72|0.271
72429474|NCT01232556|144369883|SUPERIORITY_OR_OTHER|||||||0.843||||||An hierarchical testing strategy was specified for OS, PFS and response. PFS could be tested at the 0.023 level if the OS test result were positive. Response could be tested if both the OS and PFS test results were positive.|Cochran-Mantel-Haenszel|The stratification factors are pre-randomization investigator choice, baseline sIPI, and best response to most recent chemo therapy.||Third comparison in hierarchical testing strategy was used for power calculation.||||0.843
72429475|NCT01232556|144369884|SUPERIORITY_OR_OTHER|||||||0.714||||||An hierarchical testing strategy was specified for OS, PFS and response. PFS could be tested at the 0.023 level if the OS test result were positive. Response could be tested if both the OS and PFS test results were positive.|Cochran-Mantel-Haenszel|The stratification factors are pre-randomization investigator choice, baseline sIPI, and best response to most recent chemo therapy.||Third comparison in hierarchical testing strategy was used for power calculation.||||0.714
72429476|NCT01232556|144369885|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.76||||0.142|TWO_SIDED|95.0|0.47|1.25|||Log Rank|From one sided stratified log-rank test.|From stratified Cox proportional hazards model. The stratification factors are pre-randomization investigator choice, baseline sIPI, and best response to most recent chemo therapy.|DOR was not part of the formal hypothesis testing strategy.||1.25|0.47|0.142
72429477|NCT01232556|144369886|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.02||||0.2892|TWO_SIDED|95.0|-0.02|0.06|||Mixed Models Analysis|Repeated measures mixed effects model with treatment, time, treatment-by-time interaction, and baseline as covariate.||||0.06|-0.02|0.2892
72429478|NCT01232556|144369887|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.11||||0.1879|TWO_SIDED|95.0|-1.52|7.74|||Mixed Models Analysis|Repeated measures mixed effects model with treatment, time, treatment-by-time interaction, and baseline as covariate.||||7.74|-1.52|0.1879
72429479|NCT02040090|144369908|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|We will reject the null hypothesis at the one-sided 5% significance level, and conclude that Cp \> -0.1, if the lower bound of an exact 90% binomial confidence interval (CI) exceeds0.1. A sample size of 53 in each group provides 80% power to reject the null hypothesis.|Mean Difference (Net)|-0.018|||||TWO_SIDED|90.0|-0.082|0.031||||||The null hypothesis was that Cp ≤ -0.1.||0.031|-0.082|
72429480|NCT00519636|144369967|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.8|STANDARD_ERROR_OF_MEAN|0.24|<|0.001||95.0|-1.3|-0.3|||ANCOVA||Mean Difference = Mean Change in FFNS - Mean Change in Placebo.|FFNS combined across treatment arms 1 (FFNS/FPNS) \& 2 (Placebo FF/FP) compared with Placebo FFNS combined across treatment arms 1 (FFNS/FPNS) \& 2 (Placebo FF/FP).||-0.3|-1.3|<0.001
72429481|NCT00519636|144369967|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.6|STANDARD_ERROR_OF_MEAN|0.24||0.014||95.0|-1.1|-0.1|||ANCOVA||Mean Difference = Mean Change in FPNS - Mean Change in Placebo.|FPNS combined across treatment arms 1 (FPNS/FFNS) \& 2 (Placebo FP/FF) compared with Placebo FPNS combined across treatment arms 1 (FPNS/FFNS)\& 2 (Placebo FP/FF).||-0.1|-1.1|0.014
72429482|NCT00519636|144369968|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel(CMH): stratified approximate to Prescotts test; variation of chi-square test for treatment sequence/subjects no preference.||||||<0.001
72429483|NCT00462644|144370015|SUPERIORITY_OR_OTHER|||||||0.007||95.0|||||t-test, 2 sided|||||||0.007
72429484|NCT00462644|144370016|SUPERIORITY_OR_OTHER|||||||0.011||95.0|||||t-test, 2 sided|||||||0.011
72429485|NCT00462644|144370017|SUPERIORITY_OR_OTHER|||||||0.007||95.0|||||t-test, 2 sided|||||||0.007
72429486|NCT00462644|144370018|SUPERIORITY_OR_OTHER|||||||0.022||95.0|||||t-test, 2 sided|||Normality was tested using the Kolmogorow-Smirnov test.||||0.022
72429487|NCT00462644|144370019|SUPERIORITY_OR_OTHER|||||||0.003||95.0|||||t-test, 2 sided|||||||0.003
72429488|NCT00462644|144370020|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||||||<0.001
72429489|NCT00904150|144370037|SUPERIORITY_OR_OTHER|||||||0.513|||||||Chi-squared|||Statistical analysis is of the distribution of PR PROGINS polymorphism frequencies between groups||||0.513
72429490|NCT00904150|144370038|SUPERIORITY_OR_OTHER|||||||0.75|||||||Chi-squared|||Statistical analysis is of the distribution of Estrogen receptor 1 G594a polymorphism frequencies between groups||||0.75
72429491|NCT00904150|144370039|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.434||||0.002743||95.0|0.24|0.75|||Chi-squared|||Analysis of distribution of TNF genotype frequencies between groups||0.75|0.24|0.002743
72429492|NCT00904150|144370040|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.69||||0.02462||95.0|0.49|0.95|||Chi-squared|||Analysis of distribution of SYNE1 genotype frequencies between groups||0.95|0.49|0.02462
72429493|NCT00904150|144370041|SUPERIORITY_OR_OTHER|||||||0.18|||||||Chi-squared|||Statistical analysis is of the distribution of Estrogen receptor 1 C325G polymorphism frequencies between groups||||0.18
72429494|NCT00904150|144370042|SUPERIORITY_OR_OTHER||||||>|0.05|||||||t-test, 1 sided|||||||>0.05
72429495|NCT00904150|144370043|SUPERIORITY_OR_OTHER||||||>|0.05|||||||t-test, 1 sided|||||||>0.05
72429496|NCT02718417|144370083|SUPERIORITY||Hazard Ratio (HR)|1.43||||0.989|TWO_SIDED|95.0|1.051|1.946||One-sided log-rank test was used.|Log Rank|Analysis was performed using a Cox's Proportional Hazard model stratified by the randomization strata and a stratified log-rank test.||||1.946|1.051|0.9890
72429497|NCT02718417|144370083|SUPERIORITY||Hazard Ratio (HR)|1.14||||0.7935|TWO_SIDED|95.0|0.832|1.565||One-sided log-rank test was used.|Log Rank|Analysis was performed using a Cox's Proportional Hazard model stratified by the randomization strata and a stratified log-rank test.||||1.565|0.832|0.7935
72429498|NCT02718417|144370084|SUPERIORITY||Hazard Ratio (HR)|1.53||||0.8848|TWO_SIDED|95.0|0.76|3.08||One-sided log-rank test was used.|Log Rank|Analysis was performed using a Cox's Proportional Hazard model stratified by the randomization strata and a stratified log-rank test.||||3.080|0.760|0.8848
72429499|NCT02718417|144370084|SUPERIORITY||Hazard Ratio (HR)|1.55||||0.8953|TWO_SIDED|95.0|0.776|3.111||One-sided log-rank test was used.|Log Rank|Analysis was performed using a Cox's Proportional Hazard model stratified by the randomization strata and a stratified log-rank test.||||3.111|0.776|0.8953
72429500|NCT02718417|144370085|OTHER||Hazard Ratio (HR)|1.21||||0.9278|TWO_SIDED|95.0|0.935|1.578||One-sided log-rank test was used.|Log Rank|||||1.578|0.935|0.9278
72429501|NCT02718417|144370085|OTHER||Hazard Ratio (HR)|0.9||||0.2367|TWO_SIDED|95.0|0.688|1.189||One-sided log-rank test was used.|Log Rank|||||1.189|0.688|0.2367
72429502|NCT02451930|144370133|OTHER|||||||0.4491|||||||Fisher Exact|||||||0.4491
72429503|NCT00906503|144370191|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.3|STANDARD_DEVIATION|1.6|||TWO_SIDED|95.0|0.06|31.1||||||||31.1|0.06|
72429504|NCT03220737|144370203|NON_INFERIORITY|This analysis was based on the lower confidence limit and did not entail a comparative group. The requirement was for the lower limit of the 98.3% CI be at least 70%. Multiplicity adjustment due to co-primary endpoints allotted alpha=0.017 to this endpoint resulting in a 98.3% confidence interval|Proportion|0.985|||||ONE_SIDED|98.3|0.7||||||||||0.7|
72429505|NCT03220737|144370204|NON_INFERIORITY|This analysis was based on the lower confidence limit and did not entail a comparative group. The requirement was for the lower limit of the 98.3% CI be at least 70%. Multiplicity adjustment due to coprimary endpoints allotted alpha=0.017 to this endpoint resulting in a 98.3% confidence interval.|Proportion|0.985|||||ONE_SIDED|98.3|0.7||||||||||0.7|
72429506|NCT03220737|144370205|NON_INFERIORITY|This analysis was based on the lower confidence limit and did not entail a comparative group. The requirement was for the lower limit of the 98.3% CI be at least 70%. Multiplicity adjustment due to coprimary endpoints allotted alpha=0.017 to this endpoint resulting in a 98.3% confidence interval.|Proportion|0.985|||||ONE_SIDED|98.3|0.7||||||||||0.7|
72429507|NCT03220737|144370206|NON_INFERIORITY|Non-inferiority was determined using the Newcombe method of determining the difference between two independent binomial distributions. Multiple comparison adjustment for co-primary endpoints allotted alpha=0.033 to this comparison. The lower limit of the 96.7% CI needed to be greater than -10 percentage points to prove non-inferiority.|Risk Difference (RD)|5.8|||||TWO_SIDED|96.7|2.4|7.1|||||Newcombe method of determining the difference between two independent binomial distributions|||7.1|2.4|
72429508|NCT03220737|144370207|NON_INFERIORITY|Non-inferiority was determined using the Newcombe method of determining the difference between two independent binomial distributions. Multiple comparison adjustment for co-primary endpoints allotted alpha=0.033 to this comparison. The lower limit of the 96.7% CI needed to be greater than -10 percentage points to prove non-inferiority.|Risk Difference (RD)|4.3|||||TWO_SIDED|96.7|-0.3|6.2||||||||6.2|-0.3|
72429509|NCT03220737|144370208|NON_INFERIORITY|Non-inferiority was determined using the Newcombe method of determining the difference between two independent binomial distributions. Multiple comparison adjustment for co-primary endpoints allotted alpha=0.033 to this comparison. The lower limit of the 96.7% CI needed to be greater than -10 percentage points to prove non-inferiority.|Risk Difference (RD)|4.5|||||TWO_SIDED|96.7|-1.1|6.4||||||||6.4|-1.1|
72429510|NCT03220737|144370209|SUPERIORITY|Fisher's exact test was used to compare Vaxchora vaccine to placebo on the percent of subjects who seroconverted. For Vaxchora vs placebo within each cohort at each Day on study timepoint, the p-value was the same (p\<0.0001).|||||<|0.0001|||||||Fisher Exact|||||||<0.0001
72429511|NCT03220737|144370210|SUPERIORITY|Fisher's exact test was used to compare Vaxchora vaccine to placebo on the percent of subjects who seroconverted. For Vaxchora vs placebo within each cohort at each Day on study timepoint, the p-value was the same (p\<0.0001).|||||<|0.0001|||||||Fisher Exact|||||||<0.0001
72429512|NCT03220737|144370211|SUPERIORITY|Fisher's exact test was used to compare Vaxchora vaccine to placebo on the percent of subjects who seroconverted. For Vaxchora vs placebo within each cohort at each Day on study timepoint, the p-value was the same (p\<0.0001).|||||<|0.0001|||||||Fisher Exact|||||||<0.0001
72429513|NCT03220737|144370215|SUPERIORITY|Fisher's exact test was used to compare Vaxchora vaccine to placebo on the percent of subjects who seroconverted. For Vaxchora vs placebo within each cohort at each Day on study timepoint, the p-value was the same (p\<0.0001).|||||<|0.0001|||||||Fisher Exact|||||||<0.0001
72429514|NCT03220737|144370216|SUPERIORITY|Fisher's exact test was used to compare Vaxchora vaccine to placebo on the percent of subjects who seroconverted. For Vaxchora vs placebo within each cohort at each Day on study timepoint, the p-value was the same (p\<0.0001).|||||<|0.0001|||||||Fisher Exact|||||||<0.0001
72429515|NCT00684983|144370227|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.04||||0.89|TWO_SIDED|95.0|0.58|1.89|||Regression, Cox|||Analysis of the primary endpoint, PFS, will be performed using Cox regression with treatment group as a single covariate.||1.89|0.58|.89
72429516|NCT00684983|144370228|SUPERIORITY||Hazard Ratio (HR)|1.22||||0.93|TWO_SIDED|95.0|0.5|3.0|||Log Rank|||||3|0.5|0.93
72429517|NCT00684983|144370229|SUPERIORITY||Hazard Ratio (HR)|1.01||||0.66|TWO_SIDED|95.0|0.53|1.92|||Log Rank|||||1.92|.53|.66
72429518|NCT00684983|144370231|SUPERIORITY||Hazard Ratio (HR)|0.39||||0.26|TWO_SIDED|95.0|0.09|1.53|||Log Rank|||||1.53|.09|.26
72429519|NCT00594932|144370234|SUPERIORITY_OR_OTHER_LEGACY||superiority|4.0|||=|0.041||||||This was the primary endpoint therefore no adjustment for multiple comparisons was necessary|Fisher Exact|||this is a categorical assessment. Prespecified. Fishers exact test. Significant is calculated as \< 0.05||||=0.041
72429520|NCT04496167|144370236|OTHER||Least Square Mean Treatment Difference|1.386||||0.659|TWO_SIDED|95.0|-4.804|7.577||Considered significant if p-value is less than 0.05.|MMRM||"The model included treatment, visit and interaction of treatment, visit as fixed effects, Baseline as a covariate, and repeated measures with visit/participant.~Treatment difference: EN3835 - Placebo"|Mixed Model Repeated Measures (MMRM) was performed to estimate the change from Baseline treatment effect of the adapted ASES composite score in the affected shoulder comparing EN3835 to placebo treatment.||7.577|-4.804|0.659
72429521|NCT00136916|144370276|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.045|STANDARD_ERROR_OF_MEAN|0.011||||90.0|-0.064|-0.026|||||Adjusted Primary Analysis Model includes terms of treatment, baseline pulmonary function tests (PFTs), center, age, sex, and height.|M3||-0.026|-0.064|
72429522|NCT00136916|144370276|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.003|STANDARD_ERROR_OF_MEAN|0.014||||90.0|-0.025|0.02|||||Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.|M6||0.020|-0.025|
72429523|NCT00136916|144370276|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.014||||90.0|-0.033|0.013|||||Adjusted Primary Analysis Model includes terms of treatment, baseline pulmonary function tests (PFTs), center, age, sex, and height.|M9||0.013|-0.033|
72429524|NCT00136916|144370276|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.014||||90.0|-0.044|0.004|||||Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.|M12||0.004|-0.044|
72429525|NCT00136916|144370276|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.023|STANDARD_ERROR_OF_MEAN|0.015||||90.0|-0.048|0.003|||||Adjusted Primary Analysis Model includes terms of treatment, baseline pulmonary function tests (PFTs), center, age, sex, and height.|M15||0.003|-0.048|
72429526|NCT00136916|144370276|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.023|STANDARD_ERROR_OF_MEAN|0.016||||90.0|-0.05|0.004|||||Adjusted Primary Analysis Model includes terms of treatment, baseline pulmonary function tests (PFTs), center, age, sex, and height.|M18||0.004|-0.050|
72429527|NCT00136916|144370276|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.017||||90.0|-0.047|0.007|||||Adjusted Primary Analysis Model includes terms of treatment, baseline pulmonary function tests (PFTs), center, age, sex, and height.|M21||0.007|-0.047|
72429528|NCT00136916|144370276|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.026|STANDARD_ERROR_OF_MEAN|0.017||||90.0|-0.054|0.002|||||Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.|M24||0.002|-0.054|
72429529|NCT00136916|144370276|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.007|STANDARD_ERROR_OF_MEAN|0.017||||90.0|-0.021|0.034|||||Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.|FU M1||0.034|-0.021|
72429530|NCT00136916|144370276|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.014|STANDARD_ERROR_OF_MEAN|0.018||||90.0|-0.016|0.044|||||Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.|FU M3||0.044|-0.016|
72429531|NCT00136916|144370276|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.027|STANDARD_ERROR_OF_MEAN|0.017||||90.0|-0.002|0.055|||||Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.|FU M6||0.055|-0.002|
72429532|NCT00136916|144370276|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.004|STANDARD_ERROR_OF_MEAN|0.022||||90.0|-0.04|0.032|||||Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.|Ext M1||0.032|-0.040|
72429533|NCT00136916|144370276|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.033|STANDARD_ERROR_OF_MEAN|0.023||||90.0|-0.07|0.004|||||Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.|Ext M3||0.004|-0.070|
72429534|NCT00136916|144370276|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.039|STANDARD_ERROR_OF_MEAN|0.023||||90.0|-0.077|-0.002|||||Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.|Ext M6||-0.002|-0.077|
72429535|NCT00136916|144370276|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.036|STANDARD_ERROR_OF_MEAN|0.024||||90.0|-0.075|0.003|||||Adjusted Primary Analysis Model includes terms of treatment, baseline pulmonary function tests (PFTs), center, age, sex, and height.|Ext M9||0.003|-0.075|
72429536|NCT00136916|144370276|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.018|STANDARD_ERROR_OF_MEAN|0.024||||90.0|-0.058|0.022|||||Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.|Ext M12||0.022|-0.058|
72429537|NCT00136916|144370276|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.007|STANDARD_ERROR_OF_MEAN|0.025||||90.0|-0.034|0.048|||||Adjusted Primary Analysis Model includes terms of treatment, baseline pulmonary function tests (PFTs), center, age, sex, and height.|Ext M15||0.048|-0.034|
72429538|NCT00136916|144370276|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.011|STANDARD_ERROR_OF_MEAN|0.027||||90.0|-0.055|0.033|||||Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.|Ext M18||0.033|-0.055|
72429539|NCT00136916|144370276|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.015|STANDARD_ERROR_OF_MEAN|0.026||||90.0|-0.058|0.029|||||Adjusted Primary Analysis Model includes terms of treatment, baseline pulmonary function tests (PFTs), center, age, sex, and height.|Ext M21||0.029|-0.058|
72429540|NCT00136916|144370276|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.015|STANDARD_ERROR_OF_MEAN|0.028||||90.0|-0.061|0.03|||||Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.|Ext M24||0.030|-0.061|
72429541|NCT00136916|144370276|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.026||||90.0|-0.044|0.043|||||Adjusted Primary Analysis Model includes terms of treatment, baseline pulmonary function tests (PFTs), center, age, sex, and height.|Ext M27||0.043|-0.044|
72429542|NCT00136916|144370276|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.005|STANDARD_ERROR_OF_MEAN|0.027||||90.0|-0.051|0.04|||||Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.|Ext M30||0.040|-0.051|
72429543|NCT00136916|144370276|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.008|STANDARD_ERROR_OF_MEAN|0.03||||90.0|-0.042|0.058|||||Adjusted Primary Analysis Model includes terms of treatment, baseline pulmonary function tests (PFTs), center, age, sex, and height.|Ext M33||0.058|-0.042|
72429544|NCT00136916|144370276|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.024|STANDARD_ERROR_OF_MEAN|0.032||||90.0|-0.03|0.077|||||Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.|Ext M36||0.077|-0.030|
72429545|NCT00136916|144370276|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.003|STANDARD_ERROR_OF_MEAN|0.023||||90.0|-0.042|0.035|||||Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height. Ext M36 (LOCF) based on data in the extension phase only.|Ext M36 LOCF||0.035|-0.042|
72429546|NCT00136916|144370276|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.019|STANDARD_ERROR_OF_MEAN|0.026||||90.0|-0.023|0.062|||||Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.|Ext FU M3||0.062|-0.023|
72429547|NCT00136916|144370282|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.119|STANDARD_ERROR_OF_MEAN|0.058||||90.0|-0.215|-0.023|||||Adjusted Primary Analysis Model includes terms of treatment, baseline HbA1c, and center.|M3||-0.023|-0.215|
72429548|NCT00136916|144370282|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.023|STANDARD_ERROR_OF_MEAN|0.067||||90.0|-0.133|0.087|||||Adjusted Primary Analysis Model includes terms of treatment, baseline HbA1c, and center.|M6||0.087|-0.133|
72429549|NCT00136916|144370282|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.069||||90.0|-0.104|0.124|||||Adjusted Primary Analysis Model includes terms of treatment, baseline HbA1c, and center.|M9||0.124|-0.104|
72429550|NCT00136916|144370282|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.091|STANDARD_ERROR_OF_MEAN|0.075||||90.0|-0.033|0.214|||||Adjusted Primary Analysis Model includes terms of treatment, baseline HbA1c, and center.|M12||0.214|-0.033|
72429551|NCT00136916|144370282|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.052|STANDARD_ERROR_OF_MEAN|0.081||||90.0|-0.081|0.185|||||Adjusted Primary Analysis Model includes terms of treatment, baseline HbA1c, and center.|M15||0.185|-0.081|
72429552|NCT00136916|144370282|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.09|STANDARD_ERROR_OF_MEAN|0.087||||90.0|-0.054|0.234|||||Adjusted Primary Analysis Model includes terms of treatment, baseline HbA1c, and center.|M18||0.234|-0.054|
72429553|NCT00136916|144370282|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.068|STANDARD_ERROR_OF_MEAN|0.085||||90.0|-0.073|0.208|||||Adjusted Primary Analysis Model includes terms of treatment, baseline HbA1c, and center.|M21||0.208|-0.073|
72429554|NCT00136916|144370282|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.096||||90.0|-0.058|0.257|||||Adjusted Primary Analysis Model includes terms of treatment, baseline HbA1c, and center.|M24||0.257|-0.058|
72429555|NCT00136916|144370282|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.006|STANDARD_ERROR_OF_MEAN|0.09||||90.0|-0.143|0.154|||||Adjusted Primary Analysis Model includes terms of treatment, baseline HbA1c, and center.|FU M3||0.154|-0.143|
72429556|NCT00136916|144370282|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.036|STANDARD_ERROR_OF_MEAN|0.094||||90.0|-0.119|0.19|||||Adjusted Primary Analysis Model includes terms of treatment, baseline HbA1c, and center.|FU M6||0.190|-0.119|
72429557|NCT00136916|144370282|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.019|STANDARD_ERROR_OF_MEAN|0.11||||90.0|-0.2|0.161|||||Adjusted Primary Analysis Model includes terms of treatment, baseline HbA1c, and center.|Ext M1||0.161|-0.200|
72429558|NCT00136916|144370282|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.081|STANDARD_ERROR_OF_MEAN|0.11||||90.0|-0.101|0.263|||||Adjusted Primary Analysis Model includes terms of treatment, baseline HbA1c, and center.|Ext M3||0.263|-0.101|
72429559|NCT00136916|144370282|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.141|STANDARD_ERROR_OF_MEAN|0.108||||90.0|-0.038|0.32|||||Adjusted Primary Analysis Model includes terms of treatment, baseline HbA1c, and center.|Ext M6||0.320|-0.038|
72429560|NCT00136916|144370282|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.15|STANDARD_ERROR_OF_MEAN|0.116||||90.0|-0.041|0.342|||||Adjusted Primary Analysis Model includes terms of treatment, baseline HbA1c, and center.|Ext M9||0.342|-0.041|
72429561|NCT00136916|144370282|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.104|STANDARD_ERROR_OF_MEAN|0.118||||90.0|-0.09|0.298|||||Adjusted Primary Analysis Model includes terms of treatment, baseline HbA1c, and center.|Ext M12||0.298|-0.090|
72429562|NCT00136916|144370282|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.074|STANDARD_ERROR_OF_MEAN|0.125||||90.0|-0.132|0.279|||||Adjusted Primary Analysis Model includes terms of treatment, baseline HbA1c, and center.|Ext M15||0.279|-0.132|
72429563|NCT00136916|144370282|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.087|STANDARD_ERROR_OF_MEAN|0.12||||90.0|-0.111|0.284|||||Adjusted Primary Analysis Model includes terms of treatment, baseline HbA1c, and center.|Ext M18||0.284|-0.111|
72429564|NCT00136916|144370282|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.064|STANDARD_ERROR_OF_MEAN|0.124||||90.0|-0.141|0.27|||||Adjusted Primary Analysis Model includes terms of treatment, baseline HbA1c, and center.|Ext M21||0.270|-0.141|
72429565|NCT00136916|144370282|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.047|STANDARD_ERROR_OF_MEAN|0.123||||90.0|-0.156|0.249|||||Adjusted Primary Analysis Model includes terms of treatment, baseline HbA1c, and center.|Ext M24||0.249|-0.156|
72429566|NCT00136916|144370282|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.067|STANDARD_ERROR_OF_MEAN|0.124||||90.0|-0.138|0.272|||||Adjusted Primary Analysis Model includes terms of treatment, baseline HbA1c, and center.|Ext M27||0.272|-0.138|
72429567|NCT00136916|144370282|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.046|STANDARD_ERROR_OF_MEAN|0.132||||90.0|-0.171|0.264|||||Adjusted Primary Analysis Model includes terms of treatment, baseline HbA1c, and center.|Ext M30||0.264|-0.171|
72429568|NCT00136916|144370282|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.824|STANDARD_ERROR_OF_MEAN|8.319||||90.0|-3.92|23.569|||||Adjusted Primary Analysis Model includes terms of treatment, baseline HbA1c, and center.|Ext M33||23.569|-3.920|
72429569|NCT00136916|144370282|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.011|STANDARD_ERROR_OF_MEAN|0.197||||90.0|-0.316|0.337|||||Adjusted Primary Analysis Model includes terms of treatment, baseline HbA1c, and center.|Ext M36||0.337|-0.316|
72429570|NCT00136916|144370282|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.024|STANDARD_ERROR_OF_MEAN|0.163||||90.0|-0.245|0.292|||||Adjusted Primary Analysis Model includes terms of treatment, baseline HbA1c, and center.|Ext FU M3||0.292|-0.245|
72429571|NCT00136916|144370283|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.39|STANDARD_ERROR_OF_MEAN|4.054||||90.0|-19.07|-5.71|||||Adjusted Primary Analysis Model includes terms of treatment, baseline fasting plasma glucose, and center.|M3||-5.710|-19.07|
72429572|NCT00136916|144370283|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.21|STANDARD_ERROR_OF_MEAN|4.795||||90.0|-22.11|-6.312|||||Adjusted Primary Analysis Model includes terms of treatment, baseline fasting plasma glucose, and center.|M6||-6.312|-22.11|
72429573|NCT00136916|144370283|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.96|STANDARD_ERROR_OF_MEAN|4.92||||90.0|-19.07|-2.852|||||Adjusted Primary Analysis Model includes terms of treatment, baseline fasting plasma glucose, and center.|M12||-2.852|-19.07|
72429574|NCT00136916|144370283|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.56|STANDARD_ERROR_OF_MEAN|5.052||||90.0|-20.89|-4.232|||||Adjusted Primary Analysis Model includes terms of treatment, baseline fasting plasma glucose, and center.|M24||-4.232|-20.89|
72429575|NCT00136916|144370283|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.83|STANDARD_ERROR_OF_MEAN|21.867||||90.0|-80.69|47.019|||||Adjusted Primary Analysis Model includes terms of treatment, baseline fasting plasma glucose, and center.|FU M3||47.019|-80.69|
72429576|NCT00136916|144370283|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.578|STANDARD_ERROR_OF_MEAN|7.173||||90.0|-9.257|14.412|||||Adjusted Primary Analysis Model includes terms of treatment, baseline fasting plasma glucose, and center.|FU M6||14.412|-9.257|
72429577|NCT00136916|144370283|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.46|STANDARD_ERROR_OF_MEAN|6.007||||90.0|-19.37|0.45|||||Adjusted Primary Analysis Model includes terms of treatment, baseline fasting plasma glucose, and center.|Ext M1||0.450|-19.37|
72429578|NCT00136916|144370283|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.481|STANDARD_ERROR_OF_MEAN|6.446||||90.0|-20.11|1.153|||||Adjusted Primary Analysis Model includes terms of treatment, baseline fasting plasma glucose, and center.|Ext M3||1.153|-20.11|
72429579|NCT00136916|144370283|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.76|STANDARD_ERROR_OF_MEAN|6.785||||90.0|-21.95|0.438|||||Adjusted Primary Analysis Model includes terms of treatment, baseline fasting plasma glucose, and center.|Ext M6||0.438|-21.95|
72429580|NCT00136916|144370283|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.827|STANDARD_ERROR_OF_MEAN|6.154||||90.0|-16.98|3.328|||||Adjusted Primary Analysis Model includes terms of treatment, baseline fasting plasma glucose, and center.|Ext M9||3.328|-16.98|
72429581|NCT00136916|144370283|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.287|STANDARD_ERROR_OF_MEAN|7.192||||90.0|-19.15|4.579|||||Adjusted Primary Analysis Model includes terms of treatment, baseline fasting plasma glucose, and center.|Ext M12||4.579|-19.15|
72429582|NCT00136916|144370283|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.848|STANDARD_ERROR_OF_MEAN|7.219||||90.0|-13.76|10.066|||||Adjusted Primary Analysis Model includes terms of treatment, baseline fasting plasma glucose, and center.|Ext M15||10.066|-13.76|
72429583|NCT00136916|144370283|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.022|STANDARD_ERROR_OF_MEAN|7.156||||90.0|-20.83|2.79|||||Adjusted Primary Analysis Model includes terms of treatment, baseline fasting plasma glucose, and center.|Ext M18||2.790|-20.83|
72429584|NCT00136916|144370283|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.078|STANDARD_ERROR_OF_MEAN|7.217||||90.0|-18.99|4.834|||||Adjusted Primary Analysis Model includes terms of treatment, baseline fasting plasma glucose, and center.|Ext M21||4.834|-18.99|
72429585|NCT00136916|144370283|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.53|STANDARD_ERROR_OF_MEAN|7.329||||90.0|-24.63|-0.429|||||Adjusted Primary Analysis Model includes terms of treatment, baseline fasting plasma glucose, and center.|Ext M24||-0.429|-24.63|
72429586|NCT00136916|144370283|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.07|STANDARD_ERROR_OF_MEAN|6.895||||90.0|-30.45|-7.685|||||Adjusted Primary Analysis Model includes terms of treatment, baseline fasting plasma glucose, and center.|Ext M27||-7.685|-30.45|
72429587|NCT00136916|144370283|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.22|STANDARD_ERROR_OF_MEAN|7.223||||90.0|-15.15|8.705|||||Adjusted Primary Analysis Model includes terms of treatment, baseline fasting plasma glucose, and center.|Ext M30||8.705|-15.15|
72429588|NCT00136916|144370283|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.49|STANDARD_ERROR_OF_MEAN|7.625||||90.0|-21.09|4.107|||||Adjusted Primary Analysis Model includes terms of treatment, baseline fasting plasma glucose, and center.|Ext M33||4.107|-21.09|
72429589|NCT00136916|144370283|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-21.88|STANDARD_ERROR_OF_MEAN|8.906||||90.0|-36.66|-7.105|||||Adjusted Primary Analysis Model includes terms of treatment, baseline fasting plasma glucose, and center.|Ext M36||-7.105|-36.66|
72429590|NCT00136916|144370283|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.673|STANDARD_ERROR_OF_MEAN|8.77||||90.0|-19.16|9.812|||||Adjusted Primary Analysis Model includes terms of treatment, baseline fasting plasma glucose, and center.|Ext FU M3||9.812|-19.16|
72429591|NCT00136916|144370284|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.059|STANDARD_ERROR_OF_MEAN|0.217||||90.0|-0.416|0.299|||||Adjusted Primary Analysis Model includes terms of treatment, baseline weight, and center.|M3||0.299|-0.416|
72429592|NCT00136916|144370284|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.735|STANDARD_ERROR_OF_MEAN|0.297||||90.0|-1.224|-0.246|||||Adjusted Primary Analysis Model includes terms of treatment, baseline weight, and center.|M6||-0.246|-1.224|
72429593|NCT00136916|144370284|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.642|STANDARD_ERROR_OF_MEAN|0.37||||90.0|-1.251|-0.032|||||Adjusted Primary Analysis Model includes terms of treatment, baseline weight, and center.|M12||-0.032|-1.251|
72429594|NCT00136916|144370284|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.355|STANDARD_ERROR_OF_MEAN|0.464||||90.0|-2.12|-0.589|||||Adjusted Primary Analysis Model includes terms of treatment, baseline weight, and center.|M24||-0.589|-2.120|
72429595|NCT00136916|144370284|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.303|STANDARD_ERROR_OF_MEAN|0.475||||90.0|-2.086|-0.52|||||Adjusted Primary Analysis Model includes terms of treatment, baseline weight, and center.|FU M3||-0.520|-2.086|
72429596|NCT00136916|144370284|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.557|STANDARD_ERROR_OF_MEAN|0.596||||90.0|-2.539|-0.575|||||Adjusted Primary Analysis Model includes terms of treatment, baseline weight, and center.|FU M6||-0.575|-2.539|
72429597|NCT00136916|144370284|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.904|STANDARD_ERROR_OF_MEAN|0.603||||90.0|-1.898|0.09|||||Adjusted Primary Analysis Model includes terms of treatment, baseline weight, and center.|Ext M1||0.090|-1.898|
72429598|NCT00136916|144370284|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.28|STANDARD_ERROR_OF_MEAN|0.573||||90.0|-2.225|-0.334|||||Adjusted Primary Analysis Model includes terms of treatment, baseline weight, and center.|Ext M3||-0.334|-2.225|
72429599|NCT00136916|144370284|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.834|STANDARD_ERROR_OF_MEAN|0.652||||90.0|-1.909|0.241|||||Adjusted Primary Analysis Model includes terms of treatment, baseline weight, and center.|Ext M6||0.241|-1.909|
72429600|NCT00136916|144370284|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.001|STANDARD_ERROR_OF_MEAN|0.654||||90.0|-2.08|0.078|||||Adjusted Primary Analysis Model includes terms of treatment, baseline weight, and center.|Ext M9||0.078|-2.080|
72429601|NCT00136916|144370284|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.316|STANDARD_ERROR_OF_MEAN|0.676||||90.0|-2.431|-0.2|||||Adjusted Primary Analysis Model includes terms of treatment, baseline weight, and center.|Ext M12||-0.200|-2.431|
72429602|NCT00136916|144370284|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.512|STANDARD_ERROR_OF_MEAN|0.696||||90.0|-2.661|-0.363|||||Adjusted Primary Analysis Model includes terms of treatment, baseline weight, and center.|Ext M15||-0.363|-2.661|
72429603|NCT00136916|144370284|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.313|STANDARD_ERROR_OF_MEAN|0.916||||90.0|-2.824|0.198|||||Adjusted Primary Analysis Model includes terms of treatment, baseline weight, and center.|Ext M18||0.198|-2.824|
72429604|NCT00136916|144370284|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.399|STANDARD_ERROR_OF_MEAN|0.904||||90.0|-3.891|-0.907|||||Adjusted Primary Analysis Model includes terms of treatment, baseline weight, and center.|Ext M21||-0.907|-3.891|
72429605|NCT00136916|144370284|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.566|STANDARD_ERROR_OF_MEAN|0.788||||90.0|-2.867|-0.265|||||Adjusted Primary Analysis Model includes terms of treatment, baseline weight, and center.|Ext M24||-0.265|-2.867|
72429606|NCT00136916|144370284|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.72|STANDARD_ERROR_OF_MEAN|1.041||||90.0|-4.439|-1.001|||||Adjusted Primary Analysis Model includes terms of treatment, baseline weight, and center.|Ext M27||-1.001|-4.439|
72429607|NCT00136916|144370284|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.401|STANDARD_ERROR_OF_MEAN|0.82||||90.0|-2.755|-0.047|||||Adjusted Primary Analysis Model includes terms of treatment, baseline weight, and center.|Ext M30||-0.047|-2.755|
72429608|NCT00136916|144370284|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.281|STANDARD_ERROR_OF_MEAN|0.908||||90.0|-3.781|-0.782|||||Adjusted Primary Analysis Model includes terms of treatment, baseline weight, and center.|Ext M33||-0.782|-3.781|
72429609|NCT00136916|144370284|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.766|STANDARD_ERROR_OF_MEAN|1.305||||90.0|-4.932|-0.599|||||Adjusted Primary Analysis Model includes terms of treatment, baseline weight, and center.|Ext M36||-0.599|-4.932|
72429610|NCT00136916|144370284|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.637|STANDARD_ERROR_OF_MEAN|0.898||||90.0|-3.12|-0.153|||||Adjusted Primary Analysis Model includes terms of treatment, baseline weight, and center.|Ext FU M3||-0.153|-3.120|
72429611|NCT00136916|144370290|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.251|STANDARD_ERROR_OF_MEAN|0.13||||90.0|-0.466|-0.037|||||Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.|M3||-0.037|-0.466|
72429612|NCT00136916|144370290|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.095|STANDARD_ERROR_OF_MEAN|0.139||||90.0|-0.323|0.134|||||Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.|M6||0.134|-0.323|
72429613|NCT00136916|144370290|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.084|STANDARD_ERROR_OF_MEAN|0.146||||90.0|-0.158|0.325|||||Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.|M9||0.325|-0.158|
72429614|NCT00136916|144370290|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.266|STANDARD_ERROR_OF_MEAN|0.156||||90.0|-0.524|-0.009|||||Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.|M12||-0.009|-0.524|
72429615|NCT00136916|144370290|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.181|STANDARD_ERROR_OF_MEAN|0.165||||90.0|-0.453|0.091|||||Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.|M15||0.091|-0.453|
72429616|NCT00136916|144370290|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.141|STANDARD_ERROR_OF_MEAN|0.173||||90.0|-0.427|0.145|||||Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.|M18||0.145|-0.427|
72429617|NCT00136916|144370290|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.155|STANDARD_ERROR_OF_MEAN|0.176||||90.0|-0.445|0.134|||||Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.|M21||0.134|-0.445|
72429618|NCT00136916|144370290|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.119|STANDARD_ERROR_OF_MEAN|0.189||||90.0|-0.193|0.431|||||Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.|M24||0.431|-0.193|
72429619|NCT00136916|144370290|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.617|STANDARD_ERROR_OF_MEAN|0.179||||90.0|0.322|0.911|||||Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.|FU M1||0.911|0.322|
72429620|NCT00136916|144370290|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.354|STANDARD_ERROR_OF_MEAN|0.184||||90.0|0.051|0.657|||||Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.|FU M3||0.657|0.051|
72429621|NCT00136916|144370290|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.318|STANDARD_ERROR_OF_MEAN|0.186||||90.0|0.011|0.626|||||Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.|FU M6||0.626|0.011|
72429622|NCT00136916|144370290|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.136|STANDARD_ERROR_OF_MEAN|0.22||||90.0|-0.227|0.5|||||Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.|Ext M1||0.500|-0.227|
72429623|NCT00136916|144370290|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.098|STANDARD_ERROR_OF_MEAN|0.235||||90.0|-0.289|0.485|||||Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.|Ext M3||0.485|-0.289|
72429624|NCT00136916|144370290|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.202|STANDARD_ERROR_OF_MEAN|0.226||||90.0|-0.576|0.172|||||Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.|Ext M6||0.172|-0.576|
72429625|NCT00136916|144370290|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.245|STANDARD_ERROR_OF_MEAN|0.257||||90.0|-0.18|0.669|||||Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.|Ext M9||0.669|-0.180|
72429626|NCT00136916|144370290|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.126|STANDARD_ERROR_OF_MEAN|0.248||||90.0|-0.284|0.535|||||Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.|Ext M12||0.535|-0.284|
72429627|NCT00136916|144370290|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.023|STANDARD_ERROR_OF_MEAN|0.253||||90.0|-0.395|0.441|||||Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.|Ext M15||0.441|-0.395|
72429628|NCT00136916|144370290|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.146|STANDARD_ERROR_OF_MEAN|0.247||||90.0|-0.262|0.554|||||Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.|Ext M18||0.554|-0.262|
72429629|NCT00136916|144370290|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.321|STANDARD_ERROR_OF_MEAN|0.278||||90.0|-0.138|0.78|||||Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.|Ext M21||0.780|-0.138|
72429630|NCT00136916|144370290|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.043|STANDARD_ERROR_OF_MEAN|0.28||||90.0|-0.419|0.506|||||Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.|Ext M24||0.506|-0.419|
72429631|NCT00136916|144370290|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.19|STANDARD_ERROR_OF_MEAN|0.284||||90.0|-0.279|0.659|||||Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.|Ext M27||0.659|-0.279|
72429632|NCT00136916|144370290|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.117|STANDARD_ERROR_OF_MEAN|0.28||||90.0|-0.579|0.346|||||Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.|Ext M30||0.346|-0.579|
72429633|NCT00136916|144370290|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.262|STANDARD_ERROR_OF_MEAN|0.273||||90.0|-0.189|0.714|||||Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.|Ext M33||0.714|-0.189|
72429634|NCT00136916|144370290|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.267|STANDARD_ERROR_OF_MEAN|0.383||||90.0|-0.37|0.904|||||Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.|Ext M36||0.904|-0.370|
72429635|NCT00136916|144370290|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.399|STANDARD_ERROR_OF_MEAN|0.244||||90.0|-0.003|0.802|||||Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height. Ext M36 (LOCF) based on data in the extension phase only.|Ext M36 LOCF||0.802|-0.003|
72429636|NCT00136916|144370290|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.619|STANDARD_ERROR_OF_MEAN|0.292||||90.0|0.137|1.102|||||Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.|Ext FU M3||1.102|0.137|
72429637|NCT03486899|144370307|SUPERIORITY||Odds Ratio (OR)|2.65||||0.055|TWO_SIDED|95.0|0.88|8.52|||Cochran-Mantel-Haenszel|||||8.52|0.88|0.055
72429638|NCT03486899|144370307|SUPERIORITY||Odds Ratio (OR)|1.89||||0.245|TWO_SIDED|95.0|0.61|6.27|||Cochran-Mantel-Haenszel|||||6.27|0.61|0.245
72429639|NCT03486899|144370307|SUPERIORITY||Odds Ratio (OR)|2.17||||0.129|TWO_SIDED|95.0|0.71|7.1|||Cochran-Mantel-Haenszel|||||7.10|0.71|0.129
72429640|NCT03486899|144370308|SUPERIORITY||Odds Ratio (OR)|2.2||||0.214|TWO_SIDED|95.0|0.53|10.64|||Cochran-Mantel-Haenszel|||||10.64|0.53|0.214
72429641|NCT03486899|144370308|SUPERIORITY||Odds Ratio (OR)|1.83||||0.381|TWO_SIDED|95.0|0.43|9.1|||Cochran-Mantel-Haenszel|||||9.10|0.43|0.381
72429642|NCT03486899|144370308|SUPERIORITY||Odds Ratio (OR)|2.88||||0.079|TWO_SIDED|95.0|0.75|13.48|||Cochran-Mantel-Haenszel|||||13.48|0.75|0.079
72429643|NCT03486899|144370309|SUPERIORITY||Odds Ratio (OR)|2.07||||0.18|TWO_SIDED|95.0|0.63|7.47|||Cochran-Mantel-Haenszel|||||7.47|0.63|0.180
72429644|NCT03486899|144370309|SUPERIORITY||Odds Ratio (OR)|1.37||||0.612|TWO_SIDED|95.0|0.38|5.2|||Cochran-Mantel-Haenszel|||||5.20|0.38|0.612
72363121|NCT04531176|144237332|NON_INFERIORITY|Non-inferiority was tested at the 0.05 level at 1 year and performed pairwise with Bonferroni adjusted significance levels for each paired comparison||||||0.05||||||The non-inferiority regions were set to be 0.5% for A1C. When both primary endpoints are non-inferior, superiority testing at the 0.025 overall error level with Bonferroni adjustment for each endpoint at 1 year was then performed.|t-test, 1 sided|||||||0.05
72363122|NCT00311766|144237337|SUPERIORITY_OR_OTHER||ANCOVA|0.8|||>|0.05|TWO_SIDED|95.0|||||Fisher Exact|||The primary population was the Full Analysis(FA)population. The FA population included all patients who were randomized and received at least one dose of study medication and who had at least one baseline efficacy parameter recorded||||>0.05
72363123|NCT01436526|144237339|NON_INFERIORITY_OR_EQUIVALENCE|Using an estimated intra-subject coefficient of variation of less than 20% for AUC and Cmax, and a level of significance of 5%, a sample size of 25 completers was considered sufficient to conclude bioequivalence between 2\*5 mg and 1\*10 mg rivaroxaban with 90% power, if the 2 treatment means differed by 5%.|LS-Mean Ratio, Percent|108.35||||0.0438||90.0|101.59|115.57|||ANOVA|||||115.57|101.59|0.0438
72363124|NCT01436526|144237340|NON_INFERIORITY_OR_EQUIVALENCE|Using an estimated intra-subject coefficient of variation of less than 20% for AUC and Cmax, and a level of significance of 5%, a sample size of 25 completers was considered sufficient to conclude bioequivalence between 2\*5 mg and 1\*10 mg rivaroxaban with 90% power, if the 2 treatment means differed by 5%.|LS-Mean Ratio, Percent|108.19||||0.0514||90.0|101.31|115.54|||ANOVA|||||115.54|101.31|0.0514
72363125|NCT01436526|144237341|NON_INFERIORITY_OR_EQUIVALENCE|Using an estimated intra-subject coefficient of variation of less than 20% for AUC and Cmax, and a level of significance of 5%, a sample size of 25 completers was considered sufficient to conclude bioequivalence between 2\*5 mg and 1\*10 mg rivaroxaban with 90% power, if the 2 treatment means differed by 5%.|LS-Mean Ratio, Percent|111.64||||0.0685||90.0|101.14|123.23|||ANOVA|||||123.23|101.14|0.0685
72363126|NCT03605667|144237347|SUPERIORITY|Unstructure covariance structure.|Least square mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.93||0.9809|TWO_SIDED|95.0|-1.8|1.8|||Mixed model with repeated measures|||Model based summary statistics are from a mixed model with repeated measures, including fixed effects for pooled site ID, treatment, visit, treatment-by-visit interaction, baseline, baseline-by-visit interaction, mini-mental state examination (MMSE) randomization stratification, apolipoprotein E (APoE) status (carrier/non carrier), as covariates, and repeated measures for visit within participant.||1.8|-1.8|0.9809
72363127|NCT03605667|144237348|SUPERIORITY|Unstructure covariance structure.|Least square mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.28||0.4474|TWO_SIDED|95.0|-0.8|0.3|||Mixed model with repeated measures|||Model based summary statistics are from a mixed model with repeated measures, including fixed effects for pooled site ID, treatment, visit, treatment-by-visit interaction, baseline, baseline-by-visit interaction, MMSE randomization stratification, APoE status (carrier/non carrier), as covariates, and repeated measures for visit within participant.||0.3|-0.8|0.4474
72363128|NCT03605667|144237349|SUPERIORITY|Unstructure covariance structure.|Least square mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.26||0.867|TWO_SIDED|95.0|-0.6|0.5|||ANCOVA|||Model based summary statistics were from an analysis of covariance (ANCOVA) with baseline MMSE total score as covariate.||0.5|-0.6|0.8670
72363129|NCT03605667|144237350|SUPERIORITY|Unstructure covariance structure.|Least square mean difference|1.6|STANDARD_ERROR_OF_MEAN|1.21||0.195|TWO_SIDED|95.0|-0.8|3.9|||Mixed model with repeated measures|||Model based summary statistics are from a mixed model with repeated measures, including fixed effects for pooled site ID, treatment, visit, treatment-by-visit interaction, baseline, baseline-by-visit interaction, MMSE randomization stratification, APOE status (carrier/non-carrier), as covariates, and repeated measures for visit within participant.||3.9|-0.8|0.1950
72363130|NCT03605667|144237351|SUPERIORITY|Unstructure covariance structure.|Least square mean difference|1.5|STANDARD_ERROR_OF_MEAN|1.31||0.2583|TWO_SIDED|95.0|-1.1|4.1|||Mixed model with repeated measures|||Model based summary statistics are from a mixed model with repeated measures, including fixed effects for pooled site ID, treatment, visit, treatment-by-visit interaction, baseline, baseline-by-visit interaction, MMSE randomization stratification, APOE status (carrier/non-carrier), as covariates, and repeated measures for visit within participant.||4.1|-1.1|0.2583
72363131|NCT03605667|144237352|SUPERIORITY|Unstructure covariance structure.|Least square mean difference|0.4|STANDARD_ERROR_OF_MEAN|0.48||0.4191|TWO_SIDED|95.0|-0.6|1.3|||Mixed model with repeated measures|||Model based summary statistics are from a mixed model with repeated measures, including fixed effects for pooled site ID, treatment, visit, treatment-by-visit interaction, baseline, baseline-by-visit interaction, MMSE randomization stratification, APOE status (carrier/non-carrier), as covariates, and repeated measures for visit within participant.||1.3|-0.6|0.4191
72363132|NCT03605667|144237354|SUPERIORITY||Least square mean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.38||0.224|TWO_SIDED|95.0|-1.2|0.3|||ANCOVA|||Model based summary statistics are from an ANCOVA with baseline MMSE total score as covariate.||0.3|-1.2|0.2240
72363133|NCT03605667|144237355|SUPERIORITY|||||||0.0161|||||||Fisher Exact|||||||0.0161
72363134|NCT00400179|144237454|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3952||95.0|||||Fisher Exact|||||||0.3952
72363135|NCT00400179|144237455|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.77||||0.0808|TWO_SIDED|95.0|0.57|1.03|||Log Rank|||||1.03|0.57|0.0808
72363136|NCT00400179|144237456|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.99||||0.9158|TWO_SIDED|95.0|0.86|1.14|||Log Rank|||||1.14|0.86|0.9158
72363137|NCT00400179|144237457|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.87||||0.032|TWO_SIDED|95.0|0.77|0.99|||Log Rank|||||0.99|0.77|0.0320
72363138|NCT00400179|144237458|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.92||||0.1983|TWO_SIDED|95.0|0.8|1.05|||Log Rank|||||1.05|0.80|0.1983
72368525|NCT02304367|144247139|OTHER|||||||0.041|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline ALP.||Week 240||||0.041
72368526|NCT02304367|144247140|OTHER|||||||0.817|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline BALP.||Week 24||||0.817
72368527|NCT02304367|144247140|OTHER|||||||0.042|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline BALP.||Week 48||||0.042
72368528|NCT02304367|144247140|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline BALP.||Week 96||||< 0.001
72429645|NCT03486899|144370309|SUPERIORITY||Odds Ratio (OR)|2.59||||0.079|TWO_SIDED|95.0|0.81|9.1|||Cochran-Mantel-Haenszel|||||9.10|0.81|0.079
72363139|NCT01972217|144237462|SUPERIORITY||Hazard Ratio (HR)|0.651||||0.017|TWO_SIDED|95.0|0.438|0.969|||Log Rank|||The 1-sided p-value provides a test for rejecting the null hypothesis of no treatment effect versus the superiority alternative that patients on olaparib have a lower risk of progression compared with placebo.||0.969|0.438|0.017
72363140|NCT01972217|144237475|OTHER||Odds Ratio (OR)|0.813||||0.309|TWO_SIDED|95.0|0.285|2.261||The p value was calculated with a 1-sided significance level of 2.5%.|Regression, Logistic|||||2.261|0.285|0.309
72363141|NCT01972217|144237476|OTHER||Hazard Ratio (HR)|0.781||||0.095|TWO_SIDED|95.0|0.54|1.13||The p value was calculated with a 1-sided significance level of 2.5%.|Log Rank|||Olapatib + abiraterone versus placebo + abiraterone: TFST||1.130|0.540|0.095
72363142|NCT01972217|144237476|OTHER||Hazard Ratio (HR)|0.809||||0.147|TWO_SIDED|95.0|0.545|1.201||The p value was calculated with a 1-sided significance level of 2.5%.|Log Rank|||Olaparib + abiraterone versus placebo + abiraterone: TSST||1.201|0.545|0.147
72363143|NCT01972217|144237477|OTHER||Hazard Ratio (HR)|0.911||||0.331|TWO_SIDED|95.0|0.6|1.384||The p value was calculated with a 1-sided significance level of 2.5%.|Log Rank|||||1.384|0.600|0.331
72363144|NCT01972217|144237478|OTHER||Hazard Ratio (HR)|0.788||||0.14|TWO_SIDED|95.0|0.511|1.215||The p value was calculated with a 1-sided significance level of 2.5%.|Log Rank|||||1.215|0.511|0.140
72363145|NCT02318706|144237479|SUPERIORITY|DS-5565 20 mg and 30 mg are tested against placebo at significance level of 0.025, respectively. If both arms are statistically significant, DS-5565 15 mg arm will be tested at level of 0.05. If neither of the arms is statistically significant, DS-5565 15 mg arm is no longer tested. If either DS-5565 20 mg or DS-5565 30 mg is statistically significant, DS-5565 15 mg arm is tested at level of 0.025.|Hazard Ratio (HR)|-0.03||||0.8773|TWO_SIDED|95.0|-0.35|0.3|||Mixed Models Analysis|||Week 14 change from baseline||0.30|-0.35|0.8773
72363146|NCT02318706|144237479|SUPERIORITY|DS-5565 20 mg and 30 mg are tested against placebo at significance level of 0.025, respectively. If both arms are statistically significant, DS-5565 15 mg arm will be tested at level of 0.05. If neither of the arms is statistically significant, DS-5565 15 mg arm is no longer tested. If either DS-5565 20 mg or DS-5565 30 mg is statistically significant, DS-5565 15 mg arm is tested at level of 0.025.|Hazard Ratio (HR)|-0.15||||0.3494|TWO_SIDED|95.0|-0.48|0.17|||Mixed Models Analysis|||Week 14 change from baseline||0.17|-0.48|0.3494
72363147|NCT02318706|144237479|SUPERIORITY|DS-5565 20 mg and 30 mg are tested against placebo at significance level of 0.025, respectively. If both arms are statistically significant, DS-5565 15 mg arm will be tested at level of 0.05. If neither of the arms is statistically significant, DS-5565 15 mg arm is no longer tested. If either DS-5565 20 mg or DS-5565 30 mg is statistically significant, DS-5565 15 mg arm is tested at level of 0.025.|Hazard Ratio (HR)|-0.5||||0.0027|TWO_SIDED|95.0|-0.82|-0.17|||Mixed Models Analysis|||Week 14 change from baseline||-0.17|-0.82|0.0027
72363148|NCT02798627|144237489|SUPERIORITY||||||=|0.97|||||||Chi-squared|||||||=0.97
72363149|NCT03821402|144237491|SUPERIORITY|||||||0.7645|||||||ANCOVA|||||||0.7645
72363150|NCT03821402|144237491|SUPERIORITY|||||||0.5509|||||||ANCOVA|||||||0.5509
72363151|NCT03821402|144237491|SUPERIORITY|||||||0.0488|||||||ANCOVA|||||||0.0488
72363152|NCT03821402|144237492|SUPERIORITY|||||||0.3698|||||||ANCOVA|||||||0.3698
72363153|NCT03821402|144237492|SUPERIORITY|||||||0.1972|||||||ANCOVA|||||||0.1972
72429646|NCT03486899|144370310|SUPERIORITY||Odds Ratio (OR)|0.39||||0.038|TWO_SIDED|95.0|0.15|1.03|||Cochran-Mantel-Haenszel|||||1.03|0.15|0.038
72363154|NCT03821402|144237492|SUPERIORITY|||||||0.2037|||||||ANCOVA|||||||0.2037
72363155|NCT03821402|144237497|SUPERIORITY|||||||0.4324|||||||ANCOVA|||||||0.4324
72363156|NCT03821402|144237497|SUPERIORITY|||||||0.3893|||||||ANCOVA|||||||0.3893
72363157|NCT03821402|144237497|SUPERIORITY|||||||0.0002|||||||ANCOVA|||||||0.0002
72363158|NCT03821402|144237498|SUPERIORITY|||||||0.0562|||||||ANCOVA|||||||0.0562
72363159|NCT03821402|144237498|SUPERIORITY|||||||0.015|||||||ANCOVA|||||||0.0150
72363160|NCT03821402|144237498|SUPERIORITY|||||||0.0092|||||||ANCOVA|||||||0.0092
72363161|NCT03175367|144237519|SUPERIORITY||Least Squares Mean Difference|-38.5|STANDARD_ERROR_OF_MEAN|9.1|<|0.0001|TWO_SIDED|95.0|-56.5|-20.6|||Mixed Models Analysis|||||-20.6|-56.5|< .0001
72363162|NCT03175367|144237519|SUPERIORITY||Least Squares Mean Difference|-52.9|STANDARD_ERROR_OF_MEAN|9.0|<|0.0001|TWO_SIDED|95.0|-70.7|-35.1|||Mixed Models Analysis|||||-35.1|-70.7|< .0001
72363163|NCT03175367|144237519|SUPERIORITY||Least Squares Mean Difference|-56.0|STANDARD_ERROR_OF_MEAN|9.0|<|0.0001|TWO_SIDED|95.0|-73.7|-38.3|||Mixed Models Analysis|||||-38.3|-73.7|< .0001
72363164|NCT03175367|144237519|SUPERIORITY||Least Squares Mean Difference|-24.2|STANDARD_ERROR_OF_MEAN|9.3|=|0.0109|TWO_SIDED|95.0|-42.6|-5.7||P-Value is not adjusted for multiplicity|Mixed Models Analysis|||||-5.7|-42.6|= 0.0109
72363165|NCT03175367|144237519|SUPERIORITY||Least Squares Mean Difference|-50.5|STANDARD_ERROR_OF_MEAN|9.0|<|0.0001|TWO_SIDED|95.0|-68.4|-32.6|||Mixed Models Analysis|||||-32.6|-68.4|< .0001
72363166|NCT03175367|144237520|SUPERIORITY||Least Squares Mean Difference|-26.6|STANDARD_ERROR_OF_MEAN|7.2|=|0.0003|TWO_SIDED|95.0|-40.9|-12.4|||Mixed Models Analysis|||||-12.4|-40.9|= 0.0003
72363167|NCT03175367|144237520|SUPERIORITY||Least Squares Mean Difference|-42.0|STANDARD_ERROR_OF_MEAN|7.1|<|0.0001|TWO_SIDED|95.0|-56.1|-27.9|||Mixed Models Analysis|||||-27.9|-56.1|< 0.0001
72363168|NCT03175367|144237520|SUPERIORITY||Least Squares Mean Difference|-45.5|STANDARD_ERROR_OF_MEAN|7.1|<|0.0001|TWO_SIDED|95.0|-59.5|-31.5|||Mixed Models Analysis|||||-31.5|-59.5|< 0.0001
72363169|NCT03175367|144237520|SUPERIORITY||Least Squares Mean Difference|-16.6|STANDARD_ERROR_OF_MEAN|6.6|=|0.0132|TWO_SIDED|95.0|-29.7|-3.5|||Mixed Models Analysis|||||-3.5|-29.7|= 0.0132
72363170|NCT03175367|144237520|SUPERIORITY||Least Squares Mean Difference|-39.4|STANDARD_ERROR_OF_MEAN|6.4|<|0.0001|TWO_SIDED|95.0|-52.0|-26.8|||Mixed Models Analysis|||||-26.8|-52.0|< 0.0001
72363171|NCT03175367|144237521|SUPERIORITY||Least Squares Mean Difference|-21.8|STANDARD_ERROR_OF_MEAN|8.4|=|0.0111|TWO_SIDED|95.0|-38.4|-5.1|||Mixed Models Analysis|||||-5.1|-38.4|= 0.0111
72429647|NCT03486899|144370310|SUPERIORITY||Odds Ratio (OR)|0.6||||0.256|TWO_SIDED|95.0|0.22|1.57|||Cochran-Mantel-Haenszel|||||1.57|0.22|0.256
72429648|NCT03486899|144370310|SUPERIORITY||Odds Ratio (OR)|0.65||||0.296|TWO_SIDED|95.0|0.25|1.73|||Cochran-Mantel-Haenszel|||||1.73|0.25|0.296
72429649|NCT03486899|144370311|SUPERIORITY||Odds Ratio (OR)|1.36||||0.718|TWO_SIDED|95.0|0.22|9.8|||Cochran-Mantel-Haenszel|||||9.80|0.22|0.718
72363172|NCT03175367|144237521|SUPERIORITY||Least Squares Mean Difference|-40.4|STANDARD_ERROR_OF_MEAN|8.2|<|0.0001|TWO_SIDED|95.0|-56.7|-24.0|||Mixed Models Analysis|||||-24.0|-56.7|< 0.0001
72363173|NCT03175367|144237522|SUPERIORITY||Least Squares Mean Difference|-39.3|STANDARD_ERROR_OF_MEAN|7.6|<|0.0001|TWO_SIDED|95.0|-54.4|-24.3|||Mixed Models Analysis|||||-24.3|-54.4|< 0.0001
72363174|NCT03175367|144237522|SUPERIORITY||Least Squares Mean Difference|-53.8|STANDARD_ERROR_OF_MEAN|7.6|<|0.0001|TWO_SIDED|95.0|-68.8|-38.9|||Mixed Models Analysis|||||-38.9|-68.8|< 0.0001
72363175|NCT03175367|144237522|SUPERIORITY||Least Squares Mean Difference|-58.5|STANDARD_ERROR_OF_MEAN|7.5|<|0.0001|TWO_SIDED|95.0|-73.4|-43.7|||Mixed Models Analysis|||||-43.7|-73.4|< 0.0001
72363176|NCT03175367|144237522|SUPERIORITY||Least Squares Mean Difference|-23.7|STANDARD_ERROR_OF_MEAN|8.1|=|0.0042|TWO_SIDED|95.0|-39.7|-7.7|||Mixed Models Analysis|||||-7.7|-39.7|= 0.0042
72363177|NCT03175367|144237522|SUPERIORITY||Least Squares Mean Difference|-50.9|STANDARD_ERROR_OF_MEAN|7.8|<|0.0001|TWO_SIDED|95.0|-66.4|-35.4|||Mixed Models Analysis|||||-35.4|-66.4|< 0.0001
72363178|NCT03175367|144237523|SUPERIORITY||Least Squares Mean Difference|-30.6|STANDARD_ERROR_OF_MEAN|9.7|=|0.0021|TWO_SIDED|95.0|-49.8|-11.4|||Mixed Models Analysis|||||-11.4|-49.8|= 0.0021
72363179|NCT03175367|144237523|SUPERIORITY||Least Squares Mean Difference|-54.6|STANDARD_ERROR_OF_MEAN|9.5|<|0.0001|TWO_SIDED|95.0|-73.4|-35.8|||Mixed Models Analysis|||||-35.8|-73.4|< 0.0001
72363180|NCT03175367|144237524|SUPERIORITY||Odds Ratio, log|19.4|||<|0.0001|TWO_SIDED|95.0|5.1|72.8|||Regression, Logistic|||||72.8|5.1|< 0.0001
72363181|NCT03175367|144237524|SUPERIORITY||Odds Ratio, log|23.9|||<|0.0001|TWO_SIDED|95.0|6.4|89.2|||Regression, Logistic|||||89.2|6.4|< 0.0001
72363182|NCT03175367|144237524|SUPERIORITY||Odds Ratio, log|22.1|||<|0.0001|TWO_SIDED|95.0|6.0|80.5|||Regression, Logistic|||||80.5|6.0|< 0.0001
72363183|NCT03175367|144237524|SUPERIORITY||Odds Ratio, log|8.5|||=|0.0007|TWO_SIDED|95.0|2.5|29.2|||Regression, Logistic|||||29.2|2.5|= 0.0007
72363184|NCT03175367|144237524|SUPERIORITY||Odds Ratio, log|42.3|||<|0.0001|TWO_SIDED|95.0|10.4|172.3|||Regression, Logistic|||||172.3|10.4|< 0.0001
72363185|NCT03175367|144237525|SUPERIORITY||Odds Ratio (OR)|9.6|||=|0.01|TWO_SIDED|95.0|1.7|53.5|||Regression, Logistic|||||53.5|1.7|= 0.0100
72429650|NCT03486899|144370311|SUPERIORITY||Odds Ratio (OR)|0.64||||0.632|TWO_SIDED|95.0|0.05|5.87|||Cochran-Mantel-Haenszel|||||5.87|0.05|0.632
72429651|NCT03486899|144370311|SUPERIORITY||Odds Ratio (OR)|0.32||||0.293|TWO_SIDED|95.0|0.01|4.19|||Cochran-Mantel-Haenszel|||||4.19|0.01|0.293
72363186|NCT03175367|144237525|SUPERIORITY||Odds Ratio (OR)|24.8|||=|0.0001|TWO_SIDED|95.0|4.7|129.9|||Regression, Logistic|||||129.9|4.7|= 0.0001
72363187|NCT03175367|144237525|SUPERIORITY||Odds Ratio (OR)|36.1|||<|0.0001|TWO_SIDED|95.0|6.7|194.7|||Regression, Logistic|||||194.7|6.7|< 0.0001
72363188|NCT03175367|144237525|SUPERIORITY||Odds Ratio (OR)|2.0|||=|0.3185|TWO_SIDED|95.0|0.5|8.2|||Regression, Logistic|||||8.2|0.5|= 0.3185
72363189|NCT03175367|144237525|SUPERIORITY||Odds Ratio (OR)|14.5|||<|0.0001|TWO_SIDED|95.0|3.9|54.2|||Regression, Logistic|||||54.2|3.9|< 0.0001
72363190|NCT03175367|144237526|SUPERIORITY||Odds Ratio (OR)|4.8|||=|0.0718|TWO_SIDED|95.0|0.9|26.5|||Regression, Logistic|||||26.5|0.9|= 0.0718
72363191|NCT03175367|144237526|SUPERIORITY||Odds Ratio (OR)|11.4|||=|0.0048|TWO_SIDED|95.0|2.1|62.1|||Regression, Logistic|||||62.1|2.1|= 0.0048
72363192|NCT03175367|144237526|SUPERIORITY||Odds Ratio (OR)|14.7|||=|0.0015|TWO_SIDED|95.0|2.8|76.8|||Regression, Logistic|||||76.8|2.8|= 0.0015
72363193|NCT03175367|144237526|SUPERIORITY||Odds Ratio (OR)|1.7|||=|0.527|TWO_SIDED|95.0|0.3|8.4|||Regression, Logistic|||||8.4|0.3|= 0.5270
72363194|NCT03175367|144237526|SUPERIORITY||Odds Ratio (OR)|7.7|||=|0.0047|TWO_SIDED|95.0|1.9|31.7|||Regression, Logistic|||||31.7|1.9|= 0.0047
72363195|NCT03175367|144237527|SUPERIORITY||Least Squares Mean Difference|-32.5|STANDARD_ERROR_OF_MEAN|11.5|=|0.0059|TWO_SIDED|95.0|-55.5|-9.6|||Mixed Models Analysis|||||-9.6|-55.5|= 0.0059
72363196|NCT03175367|144237527|SUPERIORITY||Least Squares Mean Difference|-54.5|STANDARD_ERROR_OF_MEAN|11.3|<|0.0001|TWO_SIDED|95.0|-77.0|-32.0|||Mixed Models Analysis|||||-32.0|-77.0|< 0.0001
72363197|NCT03175367|144237528|SUPERIORITY||Least Squares Mean Difference|-37.1|STANDARD_ERROR_OF_MEAN|5.7|<|0.0001|TWO_SIDED|95.0|-48.4|-25.8|||Mixed Models Analysis|||||-25.8|-48.4|< .0001
72363198|NCT03175367|144237528|SUPERIORITY||Least Squares Mean Difference|-46.4|STANDARD_ERROR_OF_MEAN|5.6|<|0.0001|TWO_SIDED|95.0|-57.5|-35.2|||Mixed Models Analysis|||||-35.2|-57.5|< .0001
72363199|NCT03175367|144237528|SUPERIORITY||Least Squares Mean Difference|-51.5|STANDARD_ERROR_OF_MEAN|5.6|<|0.0001|TWO_SIDED|95.0|-62.5|-40.4|||Mixed Models Analysis|||||-40.4|-62.5|< .0001
72363200|NCT03175367|144237528|SUPERIORITY||Least Squares Mean Difference|-22.2|STANDARD_ERROR_OF_MEAN|6.2|=|0.0006|TWO_SIDED|95.0|-34.6|-9.8|||Mixed Models Analysis|||||-9.8|-34.6|= 0.0006
72363201|NCT03175367|144237528|SUPERIORITY||Least Squares Mean Difference|-46.4|STANDARD_ERROR_OF_MEAN|6.1|<|0.0001|TWO_SIDED|95.0|-58.4|-34.4|||Mixed Models Analysis|||||-34.4|-58.4|< .0001
72363202|NCT03175367|144237529|SUPERIORITY||Least Squares Mean Difference|-28.4|STANDARD_ERROR_OF_MEAN|7.1|=|0.0001|TWO_SIDED|95.0|-42.6|-14.3|||Mixed Models Analysis|||||-14.3|-42.6|= 0.0001
72363203|NCT03175367|144237529|SUPERIORITY||Least Squares Mean Difference|-49.3|STANDARD_ERROR_OF_MEAN|7.0|<|0.0001|TWO_SIDED|95.0|-63.2|-35.4|||Mixed Models Analysis|||||-35.4|-63.2|< .0001
72363204|NCT03175367|144237530|SUPERIORITY||Adjusted Mean Difference|-46.1|STANDARD_ERROR_OF_MEAN|6.0|<|0.0001|TWO_SIDED|95.0|-57.8|-34.3|||Regression, Linear|||||-34.3|-57.8|< .0001
72363205|NCT03175367|144237530|SUPERIORITY||Adjusted Mean Difference|-55.8|STANDARD_ERROR_OF_MEAN|5.9|<|0.0001|TWO_SIDED|95.0|-67.3|-44.3|||Regression, Linear|||||-44.3|-67.3|< .0001
72363206|NCT03175367|144237530|SUPERIORITY||Adjusted Mean Difference|-61.5|STANDARD_ERROR_OF_MEAN|5.8|<|0.0001|TWO_SIDED|95.0|-72.9|-50.0|||Regression, Linear|||||-50.0|-72.9|< .0001
72363207|NCT03175367|144237530|SUPERIORITY||Adjusted Mean Difference|-25.2|STANDARD_ERROR_OF_MEAN|6.5|=|0.0001|TWO_SIDED|95.0|-38.0|-12.4|||Regression, Linear|||||-12.4|-38.0|= 0.0001
72363208|NCT03175367|144237530|SUPERIORITY||Adjusted Mean Difference|-45.9|STANDARD_ERROR_OF_MEAN|6.3|<|0.0001|TWO_SIDED|95.0|-58.4|-33.5|||Regression, Linear|||||-33.5|-58.4|< .0001
72429652|NCT03486899|144370312|SUPERIORITY||Odds Ratio (OR)|1.36||||0.718|TWO_SIDED|95.0|0.22|9.8|||Cochran-Mantel-Haenszel|||||9.80|0.22|0.718
72363209|NCT03175367|144237531|SUPERIORITY||Adjusted Mean Difference|-17.1|STANDARD_ERROR_OF_MEAN|7.5|=|0.0228|TWO_SIDED|95.0|-31.8|-2.4|||Regression, Linear|||||-2.4|-31.8|= 0.0228
72363210|NCT03175367|144237531|SUPERIORITY||Adjusted Mean Difference|-45.3|STANDARD_ERROR_OF_MEAN|7.3|<|0.0001|TWO_SIDED|95.0|-59.6|-31.0|||Regression, Linear|||||-31.0|-59.6|< .0001
72363211|NCT03175367|144237532|SUPERIORITY||Adjusted Mean Difference|-10.6|STANDARD_ERROR_OF_MEAN|5.7|=|0.0635|TWO_SIDED|95.0|-21.8|0.6|||Regression, Linear|||||0.6|-21.8|= 0.0635
72363212|NCT03175367|144237532|SUPERIORITY||Adjusted Mean Difference|-11.9|STANDARD_ERROR_OF_MEAN|5.5|=|0.0314|TWO_SIDED|95.0|-22.8|-1.1|||Regression, Linear|||||-1.1|-22.8|= 0.0314
72363213|NCT03175367|144237532|SUPERIORITY||Adjusted Mean Difference|-9.2|STANDARD_ERROR_OF_MEAN|5.5|=|0.0923|TWO_SIDED|95.0|-19.9|1.5|||Regression, Linear|||||1.5|-19.9|= 0.0923
72363214|NCT03175367|144237532|SUPERIORITY||Adjusted Mean Difference|-16.5|STANDARD_ERROR_OF_MEAN|5.3|=|0.0017|TWO_SIDED|95.0|-26.8|-6.2|||Regression, Linear|||||-6.2|-26.8|= 0.0017
72363215|NCT03175367|144237532|SUPERIORITY||Adjusted Mean Difference|-16.5|STANDARD_ERROR_OF_MEAN|4.9|=|0.0009|TWO_SIDED|95.0|-26.2|-6.8|||Regression, Linear|||||-6.8|-26.2|= 0.0009
72363216|NCT03175367|144237533|SUPERIORITY||Adjusted Mean Difference|-16.1|STANDARD_ERROR_OF_MEAN|5.8|=|0.0054|TWO_SIDED|95.0|-27.4|-4.7|||Regression, Linear|||||-4.7|-27.4|= 0.0054
72363217|NCT03175367|144237533|SUPERIORITY||Adjusted Mean Difference|-14.6|STANDARD_ERROR_OF_MEAN|5.5|=|0.0085|TWO_SIDED|95.0|-25.4|-3.7|||Regression, Linear|||||-3.7|-25.4|= 0.0085
72363218|NCT02151058|144237534|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.659|STANDARD_ERROR_OF_MEAN|0.0999|<|0.001|TWO_SIDED|95.0|-0.8559|-0.4622||The significance threshold level was 0.05 (two-sided).|ANCOVA|Treatment and baseline value as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-0.4622|-0.8559|<0.001
72363219|NCT02151058|144237534|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.993|STANDARD_ERROR_OF_MEAN|0.1005|<|0.001|TWO_SIDED|95.0|-1.1909|-0.7946||The significance threshold level was 0.05 (two-sided). Hypotheses were tested according to a hierarchical strategy.|ANCOVA|Treatment and baseline value as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-0.7946|-1.1909|<0.001
72363220|NCT02151058|144237534|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.334|STANDARD_ERROR_OF_MEAN|0.0812|<|0.001|TWO_SIDED|95.0|-0.4937|-0.1737||The significance threshold level was 0.05 (two-sided). Hypotheses were tested according to a hierarchical strategy.|ANCOVA|Treatment and baseline value as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-0.1737|-0.4937|<0.001
72363221|NCT02151058|144237535|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.286|STANDARD_ERROR_OF_MEAN|0.0809|<|0.001|TWO_SIDED|95.0|-0.445|-0.1263||The significance threshold level was 0.05 (two-sided).|ANCOVA|Treatment and baseline value as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-0.1263|-0.4450|<0.001
72363222|NCT02151058|144237535|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.328|STANDARD_ERROR_OF_MEAN|0.0811|<|0.001|TWO_SIDED|95.0|-0.4877|-0.1679||The significance threshold level was 0.05 (two-sided).|ANCOVA|Treatment and baseline value as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-0.1679|-0.4877|<0.001
72429653|NCT03486899|144370312|SUPERIORITY||Odds Ratio (OR)|0.64||||0.632|TWO_SIDED|95.0|0.05|5.87|||Cochran-Mantel-Haenszel|||||5.87|0.05|0.632
72363223|NCT02151058|144237535|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.042|STANDARD_ERROR_OF_MEAN|0.0653||0.52|TWO_SIDED|95.0|-0.1709|0.0866||The significance threshold level was 0.05 (two-sided).|ANCOVA|Treatment and baseline value as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.0866|-0.1709|0.520
72363224|NCT02151058|144237536|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.513|STANDARD_ERROR_OF_MEAN|0.0971|<|0.001|TWO_SIDED|95.0|-0.7043|-0.3217||The significance threshold level was 0.05 (two-sided).|ANCOVA|Treatment and baseline value as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-0.3217|-0.7043|<0.001
72363225|NCT02151058|144237536|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.685|STANDARD_ERROR_OF_MEAN|0.0975|<|0.001|TWO_SIDED|95.0|-0.877|-0.4925||The significance threshold level was 0.05 (two-sided).|ANCOVA|Treatment and baseline value as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-0.4925|-0.8770|<0.001
72363226|NCT02151058|144237536|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.172|STANDARD_ERROR_OF_MEAN|0.0786||0.03|TWO_SIDED|95.0|-0.3268|-0.0168||The significance threshold level was 0.05 (two-sided).|ANCOVA|Treatment and baseline value as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-0.0168|-0.3268|0.030
72363227|NCT02151058|144237537|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.083|STANDARD_ERROR_OF_MEAN|0.0369||0.026|TWO_SIDED|95.0|-0.1556|-0.0102||The significance threshold level was 0.05 (two-sided).|ANCOVA|Treatment and baseline value as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-0.0102|-0.1556|0.026
72363228|NCT02151058|144237537|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.118|STANDARD_ERROR_OF_MEAN|0.0372||0.002|TWO_SIDED|95.0|-0.1917|-0.0451||The significance threshold level was 0.05 (two-sided).|ANCOVA|Treatment and baseline value as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-0.0451|-0.1917|0.002
72363229|NCT02151058|144237537|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.035|STANDARD_ERROR_OF_MEAN|0.0297||0.234|TWO_SIDED|95.0|-0.094|0.0231||The significance threshold level was 0.05 (two-sided).|ANCOVA|Treatment and baseline value as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.0231|-0.0940|0.234
72363230|NCT02151058|144237538|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.176|STANDARD_ERROR_OF_MEAN|0.0568||0.002|TWO_SIDED|95.0|-0.2882|-0.0644||The significance threshold level was 0.05 (two-sided).|ANCOVA|Treatment and baseline value as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-0.0644|-0.2882|0.002
72363231|NCT02151058|144237538|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.351|STANDARD_ERROR_OF_MEAN|0.0573|<|0.001|TWO_SIDED|95.0|-0.4638|-0.2378||The significance threshold level was 0.05 (two-sided).|ANCOVA|Treatment and baseline value as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-0.2378|-0.4638|<0.001
72363232|NCT02151058|144237538|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.174|STANDARD_ERROR_OF_MEAN|0.0458|<|0.001|TWO_SIDED|95.0|-0.2648|-0.0841||The significance threshold level was 0.05 (two-sided).|ANCOVA|Treatment and baseline value as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-0.0841|-0.2648|<0.001
72363233|NCT02151058|144237539|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.247|STANDARD_ERROR_OF_MEAN|0.0631|<|0.001|TWO_SIDED|95.0|-0.3713|-0.1226||The significance threshold level was 0.05 (two-sided).|ANCOVA|Treatment and baseline value as covariates.||Treatment and baseline value as covariates.||-0.1226|-0.3713|<0.001
72363234|NCT02151058|144237539|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.498|STANDARD_ERROR_OF_MEAN|0.0638|<|0.001|TWO_SIDED|95.0|-0.6236|-0.3722||The significance threshold level was 0.05 (two-sided).|ANCOVA|Treatment and baseline value as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-0.3722|-0.6236|<0.001
72363235|NCT02151058|144237539|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.251|STANDARD_ERROR_OF_MEAN|0.0511|<|0.001|TWO_SIDED|95.0|-0.3516|-0.1503||The significance threshold level was 0.05 (two-sided).|ANCOVA|Treatment and baseline value as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-0.1503|-0.3516|<0.001
72363236|NCT02151058|144237540|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.124|STANDARD_ERROR_OF_MEAN|0.0372||0.001|TWO_SIDED|95.0|-0.197|-0.0504||The significance threshold level was 0.05 (two-sided).|ANCOVA|Treatment and baseline value as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-0.0504|-0.1970|0.001
72363237|NCT02151058|144237540|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.168|STANDARD_ERROR_OF_MEAN|0.0373|<|0.001|TWO_SIDED|95.0|-0.2413|-0.0941||The significance threshold level was 0.05 (two-sided).|ANCOVA|Treatment and baseline value as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-0.0941|-0.2413|<0.001
72363238|NCT02151058|144237540|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.044|STANDARD_ERROR_OF_MEAN|0.0301||0.145|TWO_SIDED|95.0|-0.1034|0.0152||The significance threshold level was 0.05 (two-sided).|ANCOVA|Treatment and baseline value as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.0152|-0.1034|0.145
72363239|NCT02151058|144237541|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.23|STANDARD_ERROR_OF_MEAN|0.0497|<|0.001|TWO_SIDED|95.0|-0.3282|-0.1321||The significance threshold level was 0.05 (two-sided).|ANCOVA|Treatment and baseline value as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-0.1321|-0.3282|<0.001
72363240|NCT02151058|144237541|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.313|STANDARD_ERROR_OF_MEAN|0.05|<|0.001|TWO_SIDED|95.0|-0.4113|-0.2141||The significance threshold level was 0.05 (two-sided).|ANCOVA|Treatment and baseline value as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-0.2141|-0.4113|<0.001
72363241|NCT02151058|144237541|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.083|STANDARD_ERROR_OF_MEAN|0.0404||0.042|TWO_SIDED|95.0|-0.1621|-0.0031||The significance threshold level was 0.05 (two-sided).|ANCOVA|Treatment and baseline value as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-0.0031|-0.1621|0.042
72363242|NCT02151058|144237542|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.275|STANDARD_ERROR_OF_MEAN|0.0543|<|0.001|TWO_SIDED|95.0|-0.382|-0.1679||The significance threshold level was 0.05 (two-sided).|ANCOVA|Treatment and baseline value as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-0.1679|-0.3820|<0.001
72429654|NCT03486899|144370312|SUPERIORITY||Odds Ratio (OR)|0.32||||0.293|TWO_SIDED|95.0|0.01|4.19|||Cochran-Mantel-Haenszel|||||4.19|0.01|0.293
72429655|NCT03486899|144370313|SUPERIORITY||Odds Ratio (OR)|2.55||||0.101|TWO_SIDED|95.0|0.73|10.12|||Cochran-Mantel-Haenszel|||||10.12|0.73|0.101
72429656|NCT03486899|144370313|SUPERIORITY||Odds Ratio (OR)|1.43||||0.587|TWO_SIDED|95.0|0.36|6.17|||Cochran-Mantel-Haenszel|||||6.17|0.36|0.587
72363243|NCT02151058|144237542|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.464|STANDARD_ERROR_OF_MEAN|0.0548|<|0.001|TWO_SIDED|95.0|-0.5724|-0.3565||The significance threshold level was 0.05 (two-sided).|ANCOVA|Treatment and baseline value as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-0.3565|-0.5724|<0.001
72363244|NCT02151058|144237542|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.19|STANDARD_ERROR_OF_MEAN|0.0442|<|0.001|TWO_SIDED|95.0|-0.2767|-0.1023||The significance threshold level was 0.05 (two-sided).|ANCOVA|Treatment and baseline value as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-0.1023|-0.2767|<0.001
72368529|NCT02304367|144247140|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline BALP.||Week 144||||< 0.001
72368530|NCT02304367|144247140|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline BALP.||Week 168||||< 0.001
72429657|NCT03486899|144370313|SUPERIORITY||Odds Ratio (OR)|1.72||||0.371|TWO_SIDED|95.0|0.45|7.2|||Cochran-Mantel-Haenszel|||||7.20|0.45|0.371
72429658|NCT03486899|144370314|SUPERIORITY||Odds Ratio (OR)|2.2||||0.214|TWO_SIDED|95.0|0.53|10.64|||Cochran-Mantel-Haenszel|||||10.64|0.53|0.214
72429659|NCT03486899|144370314|SUPERIORITY||Odds Ratio (OR)|1.83||||0.381|TWO_SIDED|95.0|0.43|9.1|||Cochran-Mantel-Haenszel|||||9.10|0.43|0.381
72429660|NCT03486899|144370314|SUPERIORITY||Odds Ratio (OR)|2.2||||0.214|TWO_SIDED|95.0|0.53|10.64|||Cochran-Mantel-Haenszel|||||10.64|0.53|0.214
72429661|NCT03486899|144370315|SUPERIORITY||Odds Ratio (OR)|2.85||||0.06|TWO_SIDED|95.0|0.83|11.21|||Cochran-Mantel-Haenszel|||||11.21|0.83|0.060
72429662|NCT03486899|144370315|SUPERIORITY||Odds Ratio (OR)|1.93||||0.276|TWO_SIDED|95.0|0.53|7.92|||Cochran-Mantel-Haenszel|||||7.92|0.53|0.276
72429663|NCT03486899|144370315|SUPERIORITY||Odds Ratio (OR)|1.72||||0.371|TWO_SIDED|95.0|0.45|7.2|||Cochran-Mantel-Haenszel|||||7.20|0.45|0.371
72429664|NCT03486899|144370316|SUPERIORITY||Odds Ratio (OR)|1.72||||0.242|TWO_SIDED|95.0|0.62|4.87|||Cochran-Mantel-Haenszel|||||4.87|0.62|0.242
72429665|NCT03486899|144370316|SUPERIORITY||Odds Ratio (OR)|1.1||||0.803|TWO_SIDED|95.0|0.37|3.26|||Cochran-Mantel-Haenszel|||||3.26|0.37|0.803
72429666|NCT03486899|144370316|SUPERIORITY||Odds Ratio (OR)|1.56||||0.35|TWO_SIDED|95.0|0.56|4.46|||Cochran-Mantel-Haenszel|||||4.46|0.56|0.350
72429667|NCT01439711|144370381|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
72429668|NCT01439711|144370382|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
72429669|NCT01012973|144370395|SUPERIORITY_OR_OTHER||CMH adjusted difference|38.3|||<|0.0001|TWO_SIDED|95.0|24.4|52.1|||Cochran-Mantel-Haenszel||The estimate is calculated as Eylea minus Sham. A positive value shows Eylea showed a higher BCVA total score compared to Sham.|Null hypothesis of difference of Eylea minus Sham of 0 was tested. In the database close after Week 24, basis for primary efficacy evaluation, 56 Sham / 96 Eylea subjects were considered as week 24 completers.||52.1|24.4|<.0001
72429670|NCT01012973|144370396|SUPERIORITY_OR_OTHER||Difference in Least square means|14.7|||<|0.0001|TWO_SIDED|95.0|10.8|18.7||As primary efficacy evaluation was significant, and this p-value was below significance level of two-sided \<.05, the fixed sequence testing did continue with next secondary endpoint.|ANOVA|ANOVA, adjusting for region and baseline BCVA category as fixed factors.|The difference is calculated as Eylea minus Sham. A positive value indicates Eylea showed a higher change in BCVA total score until week 24 compared to Sham.|Null hypothesis was equality in change from baseline to Week 24 in BCVA total letter score between Eylea and Sham. If primary efficacy was successful, secondary efficacy endpoints were tested in a pre-specified fixed sequence testing procedure. Change in BCVA letter score was to be tested first in this sequence.||18.7|10.8|<.0001
72429671|NCT01012973|144370397|SUPERIORITY_OR_OTHER||Difference in Least square (LS) means|-239.42|||<|0.0001|TWO_SIDED|95.0|-286.31|-192.53||As fixed sequence testing did reject nullhypothesis of change from baseline in BCVA until week 24, and this p-value was below significance level of two-sided \<.05, the fixed sequence testing did continue with next secondary endpoint.|ANCOVA|ANCOVA, stratified by region and baseline BCVA category, baseline central retinal thickness added as covariate.|The difference is calculated as Eylea minus Sham. A negative value indicates Eylea showed a higher reduction in change in central retinal thickness until week 24 compared to Sham.|Null hypothesis was equality in change from baseline to Week 24 in central retinal thickness between Eylea and Sham. If primary efficacy was successful, secondary efficacy end points were to be tested in a pre-specified fixed sequence testing procedure. Change in central retinal thickness was to be tested at second place in this sequence.||-192.53|-286.31|<.0001
72429672|NCT01012973|144370398|SUPERIORITY_OR_OTHER||CMH adjusted Difference|-1.5||||0.5947|TWO_SIDED|95.0|-7.4|4.4||As fixed sequence testing did reject nullhypothesis of change from baseline in CRT until week 24, and this p-value was not below significance level of two-sided \<.05, the fixed sequence testing did end with this evaluation.|Cochran-Mantel-Haenszel|Cochrane-Mantel-Haenszel test, stratified by region and baseline BCVA category.||Nullhypothesis of no difference in development of neovascularizations between Eylea and Sham group was tested. (Any neovascularization)||4.4|-7.4|0.5947
72429673|NCT01012973|144370399|SUPERIORITY_OR_OTHER||Difference in LS means|4.2|||||TWO_SIDED|95.0|1.7|6.8|||||As the fixed sequence of secondary endpoints stopped with proportion of neovascularizations developed until week 24, 95% confidence interval is only of descriptive nature.|||6.8|1.7|
72429674|NCT01012973|144370400|SUPERIORITY_OR_OTHER||Difference in LS Means|0.044|||||TWO_SIDED|95.0|-0.002|0.09|||||As the fixed sequence of secondary endpoints stopped with proportion of neovascularizations developed until week 24, 95% confidence interval is only of descriptive nature.|||0.09|-0.002|
72429675|NCT01782326|144370408|NON_INFERIORITY_OR_EQUIVALENCE|Study was designed to have \>95% power to rule out a 1.15-fold increase in the rate exacerbations for QVA149 vs. salmeterol/fluticasone.|Rate Ratio|0.89|||||TWO_SIDED|95.0|0.83|0.96|||Generalized linear model||If the upper limit of the confidence interval was \<1.15 then non-inferiority of QVA149 compared to SFC could be claimed|||0.96|0.83|
72429676|NCT01782326|144370408|SUPERIORITY_OR_OTHER||Rate Ratio|0.89||||0.003|TWO_SIDED|95.0|0.83|0.96|||Generalized linear method||If non-inferiority was demonstrated, superiority of QVA149A compared to SFC in reducing exacerbation rate could be claimed if the upper limit of the same CI was less than 1.|||0.96|0.83|0.003
72429677|NCT01782326|144370409|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.84|||<|0.001|TWO_SIDED|95.0|0.78|0.91|||Regression, Cox|||||0.91|0.78|<0.001
72429678|NCT01782326|144370410|SUPERIORITY_OR_OTHER||Rate Ratio|0.83|||<|0.001|TWO_SIDED|95.0|0.75|0.91|||Generalized linear model|||||0.91|0.75|<0.001
72429679|NCT01782326|144370411|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.78|||<|0.001|TWO_SIDED|95.0|0.7|0.86|||Regression, Cox|||||0.86|0.70|<0.001
72429680|NCT01782326|144370416|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.9||||0.256|TWO_SIDED|95.0|0.74|1.08|||Regression, Cox|||||1.08|0.74|0.256
72429681|NCT01782326|144370417|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.81||||0.008|TWO_SIDED|95.0|0.69|0.95|||Regression, Cox|||||0.95|0.69|0.008
72429682|NCT01782326|144370418|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.81||||0.046|TWO_SIDED|95.0|0.66|1.0|||Regression, Cox|||||1.00|0.66|0.046
72429683|NCT01782326|144370419|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.89||||0.79|TWO_SIDED|95.0|0.38|2.1|||Regression, Cox|||||2.10|0.38|0.790
72429684|NCT01473420|144370436|NON_INFERIORITY_OR_EQUIVALENCE|An equivalence margin of +/- 0.5 was considered relevant to demonstrate the equivalence of the two products.|LS Mean Difference|0.04|STANDARD_ERROR_OF_MEAN|0.104|||TWO_SIDED|95.0|-0.17|0.24||||||Least square (LS) mean and 95 percent confidence interval (CI) derived from an analysis of covariance (ANCOVA) model with fixed effect of treatment.||0.24|-0.17|
72429685|NCT01473420|144370437|NON_INFERIORITY_OR_EQUIVALENCE|An equivalence margin of +/- 0.5 was considered relevant to demonstrate the equivalence of the two products.|LS Mean Difference|-2.34|STANDARD_ERROR_OF_MEAN|6.175|||TWO_SIDED|95.0|-14.51|9.82||||||LS mean and 95 percent CI derived from an ANCOVA model with fixed effect of treatment.||9.82|-14.51|
72429686|NCT01473420|144370438|SUPERIORITY_OR_OTHER|||||||0.8338|||||||Two-sample t-test|||||||0.8338
72429687|NCT01473420|144370439|SUPERIORITY_OR_OTHER|||||||0.6895|||||||Wilcoxon Rank Sum test|P-value was calculated from a Wilcoxon Rank Sum test and t-approximation was used.||||||0.6895
72429688|NCT01473420|144370440|SUPERIORITY_OR_OTHER|||||||0.9177|||||||Wilcoxon Rank Sum test|P-value was calculated from a Wilcoxon Rank Sum test and t-approximation was used.||||||0.9177
72429689|NCT04033991|144370476|OTHER||||||<|0.0001|||||||Log Rank|||Data were compared statistically across all 3 categories (favorable, intermediate and poor).||||<0.0001
72429690|NCT04033991|144370476|OTHER||||||<|0.0001|||||||Log Rank|||Data were compared statistically across all 3 categories (favorable, intermediate and poor).||||<0.0001
72429691|NCT04033991|144370477|OTHER||||||<|0.0001|||||||Log Rank|||Data were compared statistically across all 3 categories (favorable, intermediate and poor).||||<0.0001
72429692|NCT04033991|144370477|OTHER|||||||0.0068|||||||Log Rank|||Data were compared statistically across all 3 categories (favorable, intermediate and poor).||||0.0068
72429693|NCT04033991|144370479|OTHER||||||<|0.0001|||||||Log Rank|||Data were compared statistically across all 3 categories (favorable, intermediate and poor).||||<0.0001
72429694|NCT04033991|144370479|OTHER|||||||0.0004|||||||Log Rank|||Data were compared statistically across all 3 categories (favorable, intermediate and poor).||||0.0004
72429695|NCT04033991|144370480|OTHER||||||<|0.0001|||||||Log Rank|||Data were compared statistically across all 3 categories (favorable, intermediate and poor).||||<0.0001
72429696|NCT04033991|144370480|OTHER|||||||0.0014|||||||Log Rank|||Data were compared statistically across all 3 categories (favorable, intermediate and poor).||||0.0014
72429697|NCT04033991|144370485|OTHER||||||<|0.0001|||||||Log Rank|||Data were compared statistically across all 3 categories (favorable, intermediate and poor).||||<0.0001
72429698|NCT04033991|144370485|OTHER||||||<|0.0001|||||||Log Rank|||Data were compared statistically across all 3 categories (favorable, intermediate and poor).||||<0.0001
72429699|NCT04033991|144370486|OTHER||||||<|0.0001|||||||Log Rank|||Data were compared statistically across all 3 categories (favorable, intermediate and poor).||||<0.0001
72429700|NCT04033991|144370486|OTHER|||||||0.0094|||||||Log Rank|||Data were compared statistically across all 3 categories (favorable, intermediate and poor).||||0.0094
72429701|NCT03862482|144370500|EQUIVALENCE|Intraclass Correlation Coefficient (ICC, two-way mixed-effect model) assessed inter- and intra-examiner reliability of bone level measurement on 20 radiographs. Dahlberg measurement error. Two-way, mixed effect model|Mean Difference (Final Values)|-0.85|STANDARD_ERROR_OF_MEAN|0.18|<|0.05|TWO_SIDED|95.0|-1.22|-0.49||Bonferroni correction was applied for pairwise comparisons|ANOVA|Repeated measures ANOVA. Dahlberg measurement error||Total 35 Brånemark® implants analyzed for all Configurations. Size difference expected 0.95 bone level change between B/SW/SC. Sample size 16 participants ensured 80% power to reject null hypothesis (two-sided Bonferroni-adjusted α level 0.017, pairwise comparisons between implant groups). Repeated measures ANOVA. Mixed models, repeated measures within subject. Implant type/site/configuration independent variables (length covariate). (B/SW/SC lengths compared with Kruskal-Wallis test)||-0.49|-1.22|<0.05
72429702|NCT03862482|144370500|EQUIVALENCE|Intraclass Correlation Coefficient (ICC, two-way mixed-effect model) assessed inter- and intra-examiner reliability of bone level measurement on 20 radiographs. Dahlberg measurement error. Two-way, mixed effect model|Mean Difference (Final Values)|-1.0|STANDARD_ERROR_OF_MEAN|0.18|<|0.05|TWO_SIDED|95.0|-1.35|-0.64||Bonferroni correction was applied for pairwise comparisons|ANOVA|Repeated measures ANOVA. Dahlberg measurement error||Total 36 Swede-Vent® implants analyzed for all Configurations. Size difference expected 0.95 bone level change between B/SW/SC. Sample size 16 participants ensured 80% power to reject null hypothesis (two-sided Bonferroni-adjusted α level 0.017, pairwise comparisons between implant groups). Repeated measures ANOVA. Mixed models, repeated measures within subject. Implant type/site/configuration independent variables (length covariate). (B/SW/SC lengths compared with Kruskal-Wallis test)||-0.64|-1.35|<0.05
72429703|NCT03862482|144370500|EQUIVALENCE|Intraclass Correlation Coefficient (ICC, two-way mixed-effect model) assessed inter- and intra-examiner reliability of bone level measurement on 20 radiographs. Dahlberg measurement error. Two-way, mixed effect model|Median Difference (Final Values)|-1.77|STANDARD_ERROR_OF_MEAN|0.18|<|0.05|TWO_SIDED|95.0|-2.13|-1.41||Bonferroni correction was applied for pairwise comparisons|ANOVA|Repeated measures ANOVA. Dahlberg measurement error||Total 36 Screw-Vent® implants analyzed for all Configurations. Size difference expected 0.95 bone level change between B/SW/SC. Sample size 16 participants ensured 80% power to reject null hypothesis (two-sided Bonferroni-adjusted α level 0.017, pairwise comparisons between implant groups). Repeated measures ANOVA. Mixed models, repeated measures within subject. Implant type/site/configuration independent variables (length covariate). (B/SW/SC lengths compared with Kruskal-Wallis test)||-1.41|-2.13|<0.05
72429704|NCT00738530|144370508|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.91||||0.336|TWO_SIDED|95.0|0.76|1.1|||Log Rank|||||1.10|0.76|0.3360
72429705|NCT00738530|144370510|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.75||||0.0004|TWO_SIDED|95.0|0.64|0.88|||Log Rank|||||0.88|0.64|0.0004
72429706|NCT00738530|144370511|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.73||||0.0002|TWO_SIDED|95.0|0.62|0.86|||Log Rank|||||0.86|0.62|0.0002
72429707|NCT00738530|144370513|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.78||||0.0023|TWO_SIDED|95.0|0.66|0.92|||Log Rank|||||0.92|0.66|0.0023
72429708|NCT00738530|144370514|SUPERIORITY_OR_OTHER||Difference in response rates|19.9|||<|0.0001|TWO_SIDED|95.0|13.2|26.6|||Chi-squared|||||26.6|13.2|<.0001
72429709|NCT04179461|144370519|EQUIVALENCE|The Wilcoxon signed-rank test was employed for pairwise comparison between visits for continuous data. Data for the CASI was captured at clinical visits. 3. A level of statistical significance was established at \< 0.05.||||||0.52||||||Change in CASI score from V1 to V3|Wilcoxon (Mann-Whitney)|||The modified CASI score incorporates key asthma outcomes such as symptoms, healthcare utilization, and medication dose.||||0.52
72429710|NCT04179461|144370520|EQUIVALENCE|The Wilcoxon signed-rank test was employed for pairwise comparison between visits for continuous data. Data for the c-ACT/ACT was captured at clinical visits and from monthly phone calls. Because c-ACT/ACT could vary through time, we calculated the average c-ACT/ACT between V1-V2 and V2-V3. Data analysis was performed in SAS version 9.4 (SAS, Cary, NC). A level of statistical significance was established at \< 0.05.||||||0.45||||||The change in ACT score from V1 to V2 (the period between V1 and V2).|Wilcoxon (Mann-Whitney)|||||||0.45
72363245|NCT03181932|144237547|SUPERIORITY|The primary efficacy endpoint was tested sequentially at Week 4 (end of Cycle 1), Week 12 (end of Cycle 2) and at Week 20 (end of Cycle 3). If a statistically significant difference was observed in favor of vancomycin inhalation powder compared to placebo after Cycle 1, then the mean change in the FEV1 percent predicted during Cycle 2 was to be tested. Similarly, if the effect after Cycle 2 was statistically significant, then the analysis of Baseline to end of Cycle 3 was to be tested.|Least square mean difference|1.4||||0.325|TWO_SIDED|95.0|-1.4|4.1|||Mixed Models Analysis|||Based on previous experience, a sample size of 45 participants per arm would provide 89% power to detect a statistically significant difference at alpha level of 0.05. To account for potential dropouts and/or smaller effect size in a 3-cycle trial, a sample size of 75 participants per arm was to be enrolled in the primary analysis population, which if all completed would provide 90% power to detect a difference of 3.4% at 20 weeks assuming the same standard deviation of 6.3%.||4.1|-1.4|0.325
72363246|NCT00674817|144237563|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.039|STANDARD_ERROR_OF_MEAN|0.0187|=|0.02|TWO_SIDED|90.0|0.008|0.069|||Mix model|||GSK961081 400 mcg Plus SAL versus GSK961081 400 mcg plus Placebo' at 1 hour||0.069|0.008|=0.020
72363247|NCT00674817|144237563|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.139|STANDARD_ERROR_OF_MEAN|0.0227|<|0.001|TWO_SIDED|90.0|0.101|0.176|||Mix model|||GSK961081 400 mcg Plus SAL versus GSK961081 400 mcg plus Placebo at 12 hour||0.176|0.101|<0.001
72363248|NCT00674817|144237563|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|0.123|STANDARD_ERROR_OF_MEAN|0.0217|<|0.001|TWO_SIDED|90.0|0.087|0.158|||Mix model|||GSK961081 400 mcg Plus SAL versus GSK961081 400 mcg plus Placebo at 24 hour||0.158|0.087|<0.001
72363249|NCT00674817|144237563|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.014|STANDARD_ERROR_OF_MEAN|0.0185|=|0.22|TWO_SIDED|90.0|-0.016|0.045|||Mix model|||GSK961081 400 mcg Plus IPR versus GSK961081 400 mcg plus Placebo at 1 hour||0.045|-0.016|=0.220
72363250|NCT00674817|144237563|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.124|STANDARD_ERROR_OF_MEAN|0.0225|<|0.001|TWO_SIDED|90.0|0.087|0.161|||Mix model|||GSK961081 400 mcg Plus IPR versus GSK961081 400 mcg plus Placebo at 12 hour||0.161|0.087|<0.001
72363251|NCT00674817|144237563|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|0.141|STANDARD_ERROR_OF_MEAN|0.0214|<|0.001|TWO_SIDED|90.0|0.105|0.176|||Mix model|||GSK961081 400 mcg Plus IPR versus GSK961081 400 mcg plus Placebo at 24 hour||0.176|0.105|<0.001
72363252|NCT00674817|144237563|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.019|STANDARD_ERROR_OF_MEAN|0.0188||0.155|TWO_SIDED|90.0|-0.012|0.05|||Mix model|||GSK961081 1200 mcg Plus SAL versus GSK961081 1200 mcg plus Placebo at 1 hour||0.050|-0.012|0.155
72363253|NCT00674817|144237563|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.091|STANDARD_ERROR_OF_MEAN|0.0229|<|0.001|TWO_SIDED|90.0|0.053|0.129|||Mix model|||GSK961081 1200 mcg Plus SAL versus GSK961081 1200 mcg plus Placebo at 12 hour||0.129|0.053|<0.001
72363254|NCT00674817|144237563|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.126|STANDARD_ERROR_OF_MEAN|0.022|<|0.001|TWO_SIDED|90.0|0.09|0.162|||Mix model|||GSK961081 1200 mcg Plus SAL versus GSK961081 1200 mcg plus Placebo at 24 hour||0.162|0.090|<0.001
72363255|NCT00674817|144237563|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.017|STANDARD_ERROR_OF_MEAN|0.019||0.188|TWO_SIDED|90.0|-0.015|0.048|||Mix model|||GSK961081 1200 mcg Plus IPR versus GSK961081 1200 mcg plus Placebo at 1 hour||0.048|-0.015|0.188
72363256|NCT00674817|144237563|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.055|STANDARD_ERROR_OF_MEAN|0.023|=|0.009|TWO_SIDED|90.0|0.017|0.093|||Mix model|||GSK961081 1200 mcg Plus IPR versus GSK961081 1200 mcg plus Placebo at 12 hour||0.093|0.017|=0.009
72363257|NCT00674817|144237563|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.122|STANDARD_ERROR_OF_MEAN|0.0222|<|0.001|TWO_SIDED|90.0|0.086|0.159|||Mix model|||GSK961081 1200 mcg Plus IPR versus GSK961081 1200 mcg plus Placebo at 24 hour||0.159|0.086|<0.001
72363258|NCT00674817|144237564|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.066|STANDARD_ERROR_OF_MEAN|0.0616|=|0.856|TWO_SIDED|90.0|-0.168|0.036|||Mix model|||GSK961081 400 mcg Plus SAL versus GSK961081 400 mcg plus Placebo at 1 hour||0.036|-0.168|=0.856
72363259|NCT00674817|144237564|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.092|STANDARD_ERROR_OF_MEAN|0.0496|=|0.033|TWO_SIDED|90.0|0.01|0.174|||Mix model|||GSK961081 400 mcg Plus SAL versus GSK961081 400 mcg plus Placebo at 12 hour||0.174|0.010|=0.033
72363260|NCT00674817|144237564|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.068|STANDARD_ERROR_OF_MEAN|0.0523|=|0.099|TWO_SIDED|90.0|-0.019|0.154|||Mix model|||GSK961081 400 mcg Plus SAL versus GSK961081 400 mcg plus Placebo at 24 hour||0.154|-0.019|=0.099
72363261|NCT00674817|144237564|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.067|STANDARD_ERROR_OF_MEAN|0.0612|=|0.862|TWO_SIDED|90.0|-0.168|0.034|||Mix model|||GSK961081 400 mcg Plus IPR versus GSK961081 400 mcg plus Placebo at 1 hour||0.034|-0.168|=0.862
72363262|NCT00674817|144237564|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.12|STANDARD_ERROR_OF_MEAN|0.0493|=|0.008|TWO_SIDED|90.0|0.039|0.201|||Mix model|||GSK961081 400 mcg Plus IPR versus GSK961081 400 mcg plus Placebo at 12 hour||0.201|0.039|=0.008
72363263|NCT00674817|144237564|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.0516||0.027|TWO_SIDED|90.0|0.015|0.185|||Mix model|||GSK961081 400 mcg Plus IPR versus GSK961081 400 mcg plus Placebo at 24 hour||0.185|0.015|0.027
72363264|NCT00674817|144237564|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.052|STANDARD_ERROR_OF_MEAN|0.0621|=|0.2|TWO_SIDED|90.0|-0.05|0.155|||Mix model|||GSK961081 1200 mcg Plus SAL versus GSK961081 1200 mcg plus Placebo at 1 hour||0.155|-0.050|=0.200
72368531|NCT02304367|144247140|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline BALP.||Week 192||||< 0.001
72368532|NCT02304367|144247140|OTHER|||||||0.174|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline BALP.||Week 216||||0.174
72368533|NCT02304367|144247140|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline BALP.||Week 240||||< 0.001
72429711|NCT04179461|144370520|EQUIVALENCE|The Wilcoxon signed-rank test was employed for pairwise comparison between visits for continuous data. Data for the c-ACT/ACT was captured at clinical visits and from monthly phone calls. Because c-ACT/ACT could vary through time, we calculated the average c-ACT/ACT between V1-V2 and V2-V3. Data analysis was performed in SAS version 9.4 (SAS, Cary, NC). A level of statistical significance was established at \< 0.05.||||||0.01||||||The change in ACT score from V1-V2 to V2-V3.|Wilcoxon (Mann-Whitney)|||||||0.01
72429712|NCT04179461|144370521|EQUIVALENCE|The Wilcoxon signed-rank test was employed for pairwise comparison between visits for continuous data and the Bowker's test was used to compare categorical FEV1-FVC data. Data analysis was performed in SAS version 9.4 (SAS, Cary, NC). A level of statistical significance was established at \< 0.05.||||||0.27||||||The Change in FEV1/FVC from Visit 1 to Visit 3|Wilcoxon (Mann-Whitney)|||||||0.27
72429713|NCT04179461|144370522|EQUIVALENCE|Intervention adherence and end of study adherence were each calculated based on the 30 days prior to end of intervention and V3, respectively, in order to assess a consistent timeframe. The paired Wilcoxon signed rank test was conducted to compare controller inhaler adherence during baseline, adherence intervention, and end of study.||||||0.17||||||Change between baseline (V1) to end of study (V3)|Wilcoxon (Mann-Whitney)|||||||0.17
72429714|NCT04707391|144370528|NON_INFERIORITY|Non-inferiority was to be demonstrated if the lower limit of the two-sided 95% Confidence Interval(CI) for the difference in percenatge of participants achieving a 4-fold rise in hSBA titers between MenABCWY group and MenACWY group was above -10% for serogroup A.|Difference in percentage of participants|0.2|||||TWO_SIDED|0.95|-4.38|3.5||||||To demonstrate the immunological non-inferiority of the MenABCWY vaccine, compared to MenACWY vaccine given to healthy participants, previously primed with a MenACWY vaccine, as measured by the percentages of participants achieving a 4-fold rise in hSBA titers against N. meningitidis serogroups A at 1 month after the second MenABCWY vaccination (0,6-months) and 1 month after the MenACWY vaccination (single dose).||3.50|-4.38|
72429715|NCT04707391|144370528|NON_INFERIORITY|Non-inferiority was to be demonstrated if the lower limit of the two-sided 95% Confidence Interval(CI) for the difference in percenatge of participants achieving a 4-fold rise in hSBA titers between MenABCWY group and MenACWY group was above -10% for serogroup C.|Difference in percentage of participants|0.5|||||TWO_SIDED|0.95|-4.14|3.98||||||To demonstrate the immunological non-inferiority of the MenABCWY vaccine, compared to MenACWY vaccine given to healthy participants, previously primed with a MenACWY vaccine, as measured by the percentages of participants achieving a 4-fold rise in hSBA titers against N. meningitidis serogroups C at 1 month after the second MenABCWY vaccination (0,6-months) and 1 month after the MenACWY vaccination (single dose).||3.98|-4.14|
72429716|NCT04707391|144370528|NON_INFERIORITY|Non-inferiority was to be demonstrated if the lower limit of the two-sided 95% Confidence Interval(CI) for the difference in percenatge of participants achieving a 4-fold rise in hSBA titers between MenABCWY group and MenACWY group was above -10% for each serogroup W.|Difference in percentage of participants|1.6|||||TWO_SIDED|0.95|-2.73|4.89||||||To demonstrate the immunological non-inferiority of the MenABCWY vaccine, compared to MenACWY vaccine given to healthy participants, previously primed with a MenACWY vaccine, as measured by the percentages of participants achieving a 4-fold rise in hSBA titers against N. meningitidis serogroups W at 1 month after the second MenABCWY vaccination (0,6-months) and 1 month after the MenACWY vaccination (single dose).||4.89|-2.73|
72429717|NCT04707391|144370528|NON_INFERIORITY|Non-inferiority was to be demonstrated if the lower limit of the two-sided 95% Confidence Interval(CI) for the difference in percenatge of participants achieving a 4-fold rise in hSBA titers between MenABCWY group and MenACWY group was above -10% for each serogroup Y.|Difference in percentage of participants|0.6|||||TWO_SIDED|0.95|-3.93|3.91||||||To demonstrate the immunological non-inferiority of the MenABCWY vaccine, compared to MenACWY vaccine given to healthy participants, previously primed with a MenACWY vaccine, as measured by the percentages of participants achieving a 4-fold rise in hSBA titers against N. meningitidis serogroups Y at 1 month after the second MenABCWY vaccination (0,6-months) and 1 month after the MenACWY vaccination (single dose).||3.91|-3.93|
72429718|NCT04707391|144370529|NON_INFERIORITY|Non-inferiority was to be demonstrated if the lower limit of the two-sided 95% Confidence Interval(CI) for the difference in percenatge of participants achieving a 4-fold rise in the 4-fold rise in hSBA titers (p\_MenABCWY- p\_MenACWY) is above -10% for serogroup A.|Difference in percentage of participants|-2.5|||||TWO_SIDED|0.95|-5.59|0.47||||||To demonstrate the immunological non-inferiority of the MenABCWY vaccine, compared to MenACWY vaccine given to healthy participants, previously primed with a MenACWY vaccine, as measured by the percentages of participants achieving a 4-fold rise in hSBA titers against N. meningitidis serogroups A at 1 month after the first MenABCWY vaccination (0,6-months) and 1 month after the MenACWY vaccination (single dose).||0.47|-5.59|
72429719|NCT04707391|144370529|NON_INFERIORITY|Non-inferiority was to be demonstrated if the lower limit of the two-sided 95% Confidence Interval(CI) for the difference in percenatge of participants achieving a 4-fold rise in hSBA titers (p\_MenABCWY- p\_MenACWY) is above -10% for serogroup C.|Difference in percentage of participants|0.1|||||TWO_SIDED|0.95|-2.76|2.94||||||To demonstrate the immunological non-inferiority of the MenABCWY vaccine, compared to MenACWY vaccine given to healthy participants, previously primed with a MenACWY vaccine, as measured by the percentages of participants achieving a 4-fold rise in hSBA titers against N. meningitidis serogroups C at 1 month after the first MenABCWY vaccination (0,6-months) and 1 month after the MenACWY vaccination (single dose).||2.94|-2.76|
72429720|NCT04707391|144370529|NON_INFERIORITY|Non-inferiority was to be demonstrated if the lower limit of the two-sided 95% Confidence Interval(CI) for the difference in percenatge of participants achieving a 4-fold rise in hSBA titers (p\_MenABCWY- p\_MenACWY) is above -10% for serogroup W.|Difference in percentage of participants|0.4|||||TWO_SIDED|0.95|-2.41|3.25||||||To demonstrate the immunological non-inferiority of the MenABCWY vaccine, compared to MenACWY vaccine given to healthy participants, previously primed with a MenACWY vaccine, as measured by the percentages of participants achieving a 4-fold rise in hSBA titers against N. meningitidis serogroupsW at 1 month after the first MenABCWY vaccination (0,6-months) and 1 month after the MenACWY vaccination (single dose).||3.25|-2.41|
72363265|NCT00674817|144237564|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.094|STANDARD_ERROR_OF_MEAN|0.05|=|0.031|TWO_SIDED|90.0|0.011|0.177|||Mix model|||GSK961081 1200 mcg Plus SAL versus that due to GSK961081 1200 mcg plus Placebo at 12 hour||0.177|0.011|=0.031
72363266|NCT00674817|144237564|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.092|STANDARD_ERROR_OF_MEAN|0.053|=|0.043|TWO_SIDED|90.0|0.004|0.179|||Mix model|||GSK961081 1200 mcg Plus SAL versus GSK961081 1200 mcg plus Placebo at 24 hour||0.179|0.004|=0.043
72363267|NCT00674817|144237564|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.022|STANDARD_ERROR_OF_MEAN|0.0625|=|0.637|TWO_SIDED|90.0|-0.125|0.081|||Mix model|||GSK961081 1200 mcg Plus IPR versus GSK961081 1200 mcg plus Placebo at 1 hour||0.081|-0.125|=0.637
72363268|NCT00674817|144237564|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.136|STANDARD_ERROR_OF_MEAN|0.05|=|0.004|TWO_SIDED|90.0|0.053|0.218|||Mix model|||GSK961081 1200 mcg Plus IPR versus GSK961081 1200 mcg plus Placebo at 12 hour||0.218|0.053|=0.004
72363269|NCT00674817|144237564|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.0534|=|0.031|TWO_SIDED|90.0|0.012|0.189|||Mix model|||GSK961081 1200 mcg Plus IPR versus GSK961081 1200 mcg plus Placebo at 24 hour||0.189|0.012|=0.031
72363270|NCT00674817|144237570|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.747|STANDARD_ERROR_OF_MEAN|2.1768|||TWO_SIDED|95.0|-0.547|8.041||||||GSK961081 400 mcg Plus SAL versus GSK961081 400 mcg plus Placebo over 0-4 hours||8.041|-0.547|
72363271|NCT00674817|144237570|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.712|STANDARD_ERROR_OF_MEAN|2.1453|||TWO_SIDED|95.0|-2.521|5.944||||||GSK961081 400 mcg Plus IPR versus GSK961081 400 mcg plus Placebo over 0-4 hours||5.944|-2.521|
72363272|NCT00674817|144237570|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.755|STANDARD_ERROR_OF_MEAN|2.1869|||TWO_SIDED|95.0|-2.559|6.069||||||GSK961081 1200 mcg Plus SAL versus GSK961081 1200 mcg plus Placebo over 0-4 hours||6.069|-2.559|
72363273|NCT00674817|144237570|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.231|STANDARD_ERROR_OF_MEAN|2.197|||TWO_SIDED|95.0|-5.565|3.103||||||GSK961081 1200 mcg Plus IPR versus GSK961081 1200 mcg plus Placebo over 0-4 hours||3.103|-5.565|
72363274|NCT00674817|144237571|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.558|STANDARD_ERROR_OF_MEAN|2.7064|||TWO_SIDED|95.0|-0.781|9.897||||||GSK961081 400 mcg Plus SAL versus GSK961081 400 mcg plus Placebo over 0-27 hours||9.897|-0.781|
72363275|NCT00674817|144237571|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.266|STANDARD_ERROR_OF_MEAN|2.6691|||TWO_SIDED|95.0|-2.999|7.532||||||GSK961081 400 mcg Plus IPR versus GSK961081 400 mcg plus Placebo over 0-27 hours||7.532|-2.999|
72363276|NCT00674817|144237571|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.93|STANDARD_ERROR_OF_MEAN|2.717|||TWO_SIDED|95.0|-4.429|6.29||||||GSK961081 1200 mcg Plus SAL versus GSK961081 1200 mcg plus Placebo over 0-27 hours||6.290|-4.429|
72363277|NCT00674817|144237571|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.152|STANDARD_ERROR_OF_MEAN|2.731|||TWO_SIDED|95.0|-6.539|4.236||||||GSK961081 1200 mcg Plus IPR versus GSK961081 1200 mcg plus Placebo over 0-27 hours||4.236|-6.539|
72363278|NCT00674817|144237572|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.249|STANDARD_ERROR_OF_MEAN|1.6816|||TWO_SIDED|95.0|-2.069|4.566||||||GSK961081 400 mcg Plus SAL versus GSK961081 400 mcg plus Placebo over 0-4 hours||4.566|-2.069|
72363279|NCT00674817|144237572|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.418|STANDARD_ERROR_OF_MEAN|1.6565|||TWO_SIDED|95.0|-2.85|3.687||||||GSK961081 400 mcg Plus SAL versus GSK961081 400 mcg plus Placebo over 0-4 hours||3.687|-2.850|
72363280|NCT00674817|144237572|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.65|STANDARD_ERROR_OF_MEAN|1.705|||TWO_SIDED|95.0|-4.013|2.714||||||GSK961081 1200 mcg Plus IPR versus GSK961081 1200 mcg plus Placebo over 0-4 hours||2.714|-4.013|
72363281|NCT00674817|144237572|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.949|STANDARD_ERROR_OF_MEAN|1.7112|||TWO_SIDED|95.0|-5.325|1.427||||||GSK961081 1200 mcg Plus IPR versus GSK961081 1200 mcg plus Placebo over 0-4 hours||1.427|-5.325|
72363282|NCT00674817|144237573|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|10.198|STANDARD_ERROR_OF_MEAN|2.5039|||TWO_SIDED|95.0|5.258|15.139||||||GSK961081 400 mcg Plus SAL versus GSK961081 400 mcg plus Placebo during 0-4 hours||15.139|5.258|
72363283|NCT00674817|144237573|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.686|STANDARD_ERROR_OF_MEAN|2.4738|||TWO_SIDED|95.0|-2.195|7.567||||||GSK961081 400 mcg Plus IPR versus GSK961081 400 mcg plus Placebo during 0-4 hours||7.567|-2.195|
72363284|NCT00674817|144237573|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|7.854|STANDARD_ERROR_OF_MEAN|2.5196|||TWO_SIDED|95.0|2.883|12.825||||||GSK961081 1200 mcg Plus SAL versus GSK961081 1200 mcg plus Placebo during 0-4 hours||12.825|2.883|
72363285|NCT00674817|144237573|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.884|STANDARD_ERROR_OF_MEAN|2.5244|||TWO_SIDED|95.0|-5.864|4.097||||||GSK961081 1200 mcg Plus IPR versus GSK961081 1200 mcg plus Placebo during 0-4 hours||4.097|-5.864|
72363286|NCT00674817|144237573|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|11.227|STANDARD_ERROR_OF_MEAN|2.9782|||TWO_SIDED|95.0|5.352|17.103||||||GSK961081 400 mcg Plus SAL versus GSK961081 400 mcg plus Placebo during 0-27 hours||17.103|5.352|
72363287|NCT00674817|144237573|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.39|STANDARD_ERROR_OF_MEAN|2.9434|||TWO_SIDED|95.0|-1.418|10.197||||||GSK961081 400 mcg Plus IPR versus GSK961081 400 mcg plus Placebo during 0-27 hours||10.197|-1.418|
72363288|NCT00674817|144237573|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.975|STANDARD_ERROR_OF_MEAN|2.9958|||TWO_SIDED|95.0|0.065|11.886||||||GSK961081 1200 mcg Plus SAL versus GSK961081 1200 mcg plus Placebo during 0-27 hours||11.886|0.065|
72363289|NCT00674817|144237573|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.083|STANDARD_ERROR_OF_MEAN|3.0023|||TWO_SIDED|95.0|-8.006|3.84||||||GSK961081 1200 mcg Plus IPR versus GSK961081 1200 mcg plus Placebo during 0-27 hours||3.840|-8.006|
72363290|NCT00674817|144237574|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.2|STANDARD_ERROR_OF_MEAN|1.6941|||TWO_SIDED|95.0|1.857|8.542||||||GSK961081 400 mcg Plus SAL versus GSK961081 400 mcg plus Placebo during 0-4 hours||8.542|1.857|
72363291|NCT00674817|144237574|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.007|STANDARD_ERROR_OF_MEAN|1.6727|||TWO_SIDED|95.0|-3.294|3.307||||||GSK961081 400 mcg Plus IPR versus GSK961081 400 mcg plus Placebo during 0-4 hours||3.307|-3.294|
72363292|NCT00674817|144237574|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.956|STANDARD_ERROR_OF_MEAN|1.7178|||TWO_SIDED|95.0|-0.433|6.345||||||GSK961081 1200 mcg Plus SAL versus GSK961081 1200 mcg plus Placebo during 0-4 hours||6.345|-0.433|
72368534|NCT02304367|144247141|OTHER|||||||0.694|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline BALP.||Week 24||||0.694
72429721|NCT04707391|144370529|NON_INFERIORITY|Non-inferiority was to be demonstrated if the lower limit of the two-sided 95% Confidence Interval(CI) for the difference in percenatge of participants achieving a 4-fold rise in hSBA titers (p\_MenABCWY- p\_MenACWY) is above -10% for serogroup Y.|Difference in percentage of participants|-0.8|||||TWO_SIDED|0.95|-3.62|2.09||||||To demonstrate the immunological non-inferiority of the MenABCWY vaccine, compared to MenACWY vaccine given to healthy participants, previously primed with a MenACWY vaccine, as measured by the percentages of participants achieving a 4-fold rise in hSBA titers against N. meningitidis serogroups Y at 1 month after the first MenABCWY vaccination (0,6-months) and 1 month after the MenACWY vaccination (single dose).||2.09|-3.62|
72429722|NCT01438229|144370561|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||t-test, 2 sided|||||||<0.0001
72429723|NCT03259373|144370608|SUPERIORITY||Odds Ratio (OR)|1.01|STANDARD_ERROR_OF_MEAN|0.031||0.79|TWO_SIDED|95.0|0.95|1.07|||fixed-effect meta-analysis|||The null hypothesis was the that proportions of patients with at least one OAC filled at one year were the same between the two groups.||1.07|0.95|0.79
72429724|NCT03259373|144370608|SUPERIORITY||Odds Ratio (OR)|1.04|STANDARD_ERROR_OF_MEAN|0.039||0.307|TWO_SIDED|95.0|0.96|1.12|||fixed-effect meta-analysis|||The null hypothesis was that the proportions of patients with at least one OAC filled at 183 days were the same between the two groups.||1.12|0.96|0.307
72429725|NCT03259373|144370608|SUPERIORITY||Odds Ratio (OR)|1.05|STANDARD_ERROR_OF_MEAN|0.052||0.375|TWO_SIDED|95.0|0.95|1.16|||fixed-effect meta-analysis|||The null hypothesis was that the proportions of patients with at least one OAC filled at 90 days were the same between the two groups.||1.16|0.95|0.375
72429726|NCT03259373|144370608|SUPERIORITY||Odds Ratio (OR)|1.09|STANDARD_ERROR_OF_MEAN|0.076||0.265|TWO_SIDED|95.0|0.94|1.26|||fixed-effect meta-analysis|||The null hypothesis was that the proportions of patients with at least one OAC filled at 42 days were the same between the two groups.||1.26|0.94|0.265
72429727|NCT03259373|144370608|SUPERIORITY||Odds Ratio (OR)|1.05|STANDARD_ERROR_OF_MEAN|0.044||0.237|TWO_SIDED|95.0|0.97|1.15|||fixed-effect meta-analysis|||The null hypothesis was that the proportions of patients with at least one OAC filled among females were the same between the two groups.||1.15|0.97|0.237
72429728|NCT03259373|144370608|SUPERIORITY||Odds Ratio (OR)|0.97|STANDARD_ERROR_OF_MEAN|0.042||0.487|TWO_SIDED|95.0|0.89|1.05|||fixed-effect meta-analysis|||The null hypothesis was that the proportions of patients with at least one OAC filled among males were the same between the two groups.||1.05|0.89|0.487
72429729|NCT03259373|144370608|SUPERIORITY||Odds Ratio (OR)|0.99|STANDARD_ERROR_OF_MEAN|0.125||0.952|TWO_SIDED|95.0|0.78|1.27|||fixed-effect meta-analysis|||The null hypothesis was that the proportions of patients with at least one OAC filled among age \<= 64 yrs were the same between the two groups.||1.27|0.78|0.952
72429730|NCT03259373|144370608|SUPERIORITY||Odds Ratio (OR)|1.02|STANDARD_ERROR_OF_MEAN|0.057||0.696|TWO_SIDED|95.0|0.91|1.14|||fixed-effect meta-analysis|||The null hypothesis was that the proportions of the patients with at least one OAC filled among age 65 - 74 yrs were the same between the two groups.||1.14|0.91|0.696
72429731|NCT03259373|144370608|SUPERIORITY||Odds Ratio (OR)|1.03|STANDARD_ERROR_OF_MEAN|0.047||0.584|TWO_SIDED|95.0|0.94|1.13|||fixed-effect meta-analysis|||The null hypothesis was that the proportions of patients with at least one OAC filled among age 75 - 84 yrs were the same between groups.||1.13|0.94|0.584
72429732|NCT03259373|144370608|SUPERIORITY||Odds Ratio (OR)|0.99|STANDARD_ERROR_OF_MEAN|0.069||0.911|TWO_SIDED|95.0|0.87|1.14|||fixed-effect meta-analysis|||The null hypothesis was that the proportions of patients with at least one OAC filled among age \>= 85 yrs were the same between the two groups.||1.14|0.87|0.911
72429733|NCT03259373|144370608|SUPERIORITY||Odds Ratio (OR)|0.98|STANDARD_ERROR_OF_MEAN|0.057||0.746|TWO_SIDED|95.0|0.88|1.1|||fixed-effect meta-analysis|||The null hypothesis was that the proportions of the patients with at least one OAC filled among those with a CHADS-VASC of 2-3 were the same between the two groups.||1.10|0.88|0.746
72429734|NCT03259373|144370608|SUPERIORITY||Odds Ratio (OR)|1.08|STANDARD_ERROR_OF_MEAN|0.048||0.109|TWO_SIDED|95.0|0.98|1.19|||fixed-effect meta-analysis|||The null hypothesis was that the proportions of patients with at least one OAC filled among those with a CHADS-VASC score of 4-5 were the same between the two groups.||1.19|0.98|0.109
72429735|NCT03259373|144370608|SUPERIORITY||Odds Ratio (OR)|0.94|STANDARD_ERROR_OF_MEAN|0.057||0.244|TWO_SIDED|95.0|0.84|1.05|||fixed-effect meta-analysis|||The null hypothesis was that the proportions of patients with at least one OAC filled among those with a CHADS-VASC score \>=6 were the same between the two groups.||1.05|0.84|0.244
72429736|NCT03259373|144370609|SUPERIORITY||Hazard Ratio (HR)|0.92|STANDARD_ERROR_OF_MEAN|0.079||0.3|TWO_SIDED|95.0|0.79|1.08|||fixed-effect meta-analysis|||There were one or two sites that had no adverse events or just one event in either or both arms, so there was no estimated effect size/variance from the multivariable models at the site level. Therefore, depending on the specific outcome, either one or two sites did not contribute to the fixed-effect meta-analysis as there was no estimated effect size or variance to include in the meta-analysis.||1.08|0.79|0.300
72429737|NCT03259373|144370610|SUPERIORITY||Hazard Ratio (HR)|1.31|STANDARD_ERROR_OF_MEAN|0.172||0.122|TWO_SIDED|95.0|0.93|1.83|||fixed-effect meta-analysis|||There were one or two sites that had no adverse events or just one event in either or both arms, so there was no estimated effect size/variance from the multivariable models at the site level. Therefore, depending on the specific outcome, either one or two sites did not contribute to the fixed-effect meta-analysis as there was no estimated effect size or variance to include in the meta-analysis.||1.83|0.93|0.122
72429738|NCT03259373|144370611|SUPERIORITY||Hazard Ratio (HR)|0.98|STANDARD_ERROR_OF_MEAN|0.073||0.76|TWO_SIDED|95.0|0.85|1.13|||fixed-effect meta-analysis|||There were one or two sites that had no adverse events or just one event in either or both arms, so there was no estimated effect size/variance from the multivariable models at the site level. Therefore, depending on the specific outcome, either one or two sites did not contribute to the fixed-effect meta-analysis as there was no estimated effect size or variance to include in the meta-analysis.||1.13|0.85|0.760
72429739|NCT03259373|144370612|SUPERIORITY||Hazard Ratio (HR)|0.99|STANDARD_ERROR_OF_MEAN|0.072||0.76|TWO_SIDED|95.0|0.86|1.14|||fixed-effect meta-analysis|||There were one or two sites that had no adverse events or just one event in either or both arms, so there was no estimated effect size/variance from the multivariable models at the site level. Therefore, depending on the specific outcome, either one or two sites did not contribute to the fixed-effect meta-analysis as there was no estimated effect size or variance to include in the meta-analysis.||1.14|0.86|0.760
72429740|NCT03259373|144370613|SUPERIORITY||Hazard Ratio (HR)|0.97|STANDARD_ERROR_OF_MEAN|0.052||0.616|TWO_SIDED|95.0|0.88|1.08|||fixed-effect meta-analysis|||There were one or two sites that had no adverse events or just one event in either or both arms, so there was no estimated effect size/variance from the multivariable models at the site level. Therefore, depending on the specific outcome, either one or two sites did not contribute to the fixed-effect meta-analysis as there was no estimated effect size or variance to include in the meta-analysis.||1.08|0.88|0.616
72429741|NCT03259373|144370614|SUPERIORITY||Hazard Ratio (HR)|1.0|STANDARD_ERROR_OF_MEAN|0.072||0.992|TWO_SIDED|95.0|0.87|1.15|||fixed-effect meta-analysis|||There were one or two sites that had no adverse events or just one event in either or both arms, so there was no estimated effect size/variance from the multivariable models at the site level. Therefore, depending on the specific outcome, either one or two sites did not contribute to the fixed-effect meta-analysis as there was no estimated effect size or variance to include in the meta-analysis.||1.15|0.87|0.992
72429742|NCT03259373|144370615|SUPERIORITY||Hazard Ratio (HR)|1.01|STANDARD_ERROR_OF_MEAN|0.029||0.808|TWO_SIDED|95.0|0.95|1.07|||fixed-effect meta-analysis|||||1.07|0.95|0.808
72429743|NCT03259373|144370616|SUPERIORITY||Standardized Mean Difference (%)|-0.51|STANDARD_ERROR_OF_MEAN|0.027||0.853|TWO_SIDED||||||fixed-effect meta-analysis|||||||0.853
72429744|NCT03259373|144370617|SUPERIORITY||Odds Ratio (OR)|0.93|STANDARD_ERROR_OF_MEAN|0.066||0.303|TWO_SIDED|95.0|0.82|1.06|||fixed-effect meta-analysis|||||1.06|0.82|0.303
72429745|NCT03259373|144370618|SUPERIORITY||Hazard Ratio (HR)|1.03|STANDARD_ERROR_OF_MEAN|0.063||0.649|TWO_SIDED|95.0|0.91|1.16|||fixed-effect meta-analysis|||There were one or two sites that had no adverse events or just one event in either or both arms, so there was no estimated effect size/variance from the multivariable models at the site level. Therefore, depending on the specific outcome, either one or two sites did not contribute to the fixed-effect meta-analysis as there was no estimated effect size or variance to include in the meta-analysis.||1.16|0.91|0.649
72429746|NCT03259373|144370619|SUPERIORITY||Standardized Mean Difference (%)|-0.4998|STANDARD_ERROR_OF_MEAN|0.009||0.587|TWO_SIDED||||||fixed-effect meta-analysis|||||||0.587
72429747|NCT03259373|144370619|SUPERIORITY||Standardized Mean Difference (%)|-0.4655|STANDARD_ERROR_OF_MEAN|0.009||0.613|TWO_SIDED||||||fixed-effect meta-analysis|||||||0.613
72429748|NCT03259373|144370619|SUPERIORITY||Standardized Mean Difference (%)|0.598|STANDARD_ERROR_OF_MEAN|0.009||0.515|TWO_SIDED||||||fixed-effect meta-analysis|||||||0.515
72429749|NCT03259373|144370619|SUPERIORITY||Standardized Mean Difference (%)|-2.17|STANDARD_ERROR_OF_MEAN|0.009||0.018|TWO_SIDED||||||fixed-effect meta-analysis|||||||0.018
72363293|NCT00674817|144237574|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.683|STANDARD_ERROR_OF_MEAN|1.7199|||TWO_SIDED|95.0|-5.076|1.711||||||GSK961081 1200 mcg Plus IPR versus GSK961081 1200 mcg plus Placebo during 0-4 hours||1.711|-5.076|
72429750|NCT03259373|144370619|SUPERIORITY||Standardized Mean Difference (%)|0.05|STANDARD_ERROR_OF_MEAN|0.009||0.956|TWO_SIDED||||||fixed-effect meta-analysis|||||||0.956
72429751|NCT03259373|144370620|SUPERIORITY||Standardized Mean Difference (%)|-1.018|STANDARD_ERROR_OF_MEAN|0.009||0.279|TWO_SIDED||||||fixed-effect meta-analysis|||||||0.279
72429752|NCT03259373|144370620|SUPERIORITY||Standardized Mean Difference (%)|-1.347|STANDARD_ERROR_OF_MEAN|0.009||0.143|TWO_SIDED||||||fixed-effect meta-analysis|||||||0.143
72429753|NCT04894903|144370621|OTHER||Odds Ratio (OR)|0.45|||<|0.001|TWO_SIDED|95.0|0.3|0.68||This is the calculated p-value. We used an alpha level of 0.05|Mixed Models Analysis|Adjusted for baseline number of gaps||||0.68|0.30|<0.001
72429754|NCT04894903|144370623|OTHER||Odds Ratio (OR)|0.57||||0.29|TWO_SIDED|95.0|0.2|1.62|||Mixed Models Analysis|||||1.62|0.20|0.29
72429755|NCT04894903|144370624|OTHER||beta coefficient|-0.04||||0.74|TWO_SIDED|95.0|-0.24|0.17|||Mixed Models Analysis|||||0.17|-0.24|0.74
72429756|NCT04894903|144370625|OTHER||beta coefficient|-0.04||||0.88|TWO_SIDED|95.0|-0.6|0.51|||Mixed Models Analysis|||||0.51|-0.60|0.88
72429757|NCT04894903|144370626|OTHER||beta coefficient|-1.24||||0.21|TWO_SIDED|95.0|-3.19|0.71|||Mixed Models Analysis|||||0.71|-3.19|0.21
72429758|NCT04894903|144370629|OTHER||beta coefficient|0.47||||0.21|TWO_SIDED|95.0|-0.27|1.22|||Mixed Models Analysis|||||1.22|-0.27|0.21
72429759|NCT00322868|144370635|SUPERIORITY_OR_OTHER|||||||0.2772|TWO_SIDED||||||t-test, 1 sided|Paired t-test analysis of the intra-subject change in log10 sputum white cell count||||||0.2772
72429760|NCT00322868|144370636|SUPERIORITY_OR_OTHER|||||||0.2467|TWO_SIDED||||||t-test, 1 sided|Paired t-test analysis of the intra-subject change in log10 sputum neutrophil count||||||0.2467
72429761|NCT00322868|144370637|SUPERIORITY_OR_OTHER|||||||0.0288|TWO_SIDED||||||t-test, 1 sided|Paired t-test analysis of the intra-subject change in sputum percent neutrophils||||||0.0288
72429762|NCT00322868|144370638|SUPERIORITY_OR_OTHER|||||||0.5|TWO_SIDED||||||t-test, 1 sided|Paired t-test analysis of the intra-subject change in log10 sputum active elastase||||||0.50
72429763|NCT00322868|144370639|SUPERIORITY_OR_OTHER|||||||0.62|TWO_SIDED||||||t-test, 1 sided|Paired t-test analysis of the intra-subject change in log10 sputum TNFα||||||0.62
72429764|NCT00322868|144370640|SUPERIORITY_OR_OTHER|||||||0.5|TWO_SIDED||||||t-test, 1 sided|Paired t-test analysis of the intra-subject change in log10 sputum IL-1ß||||||0.50
72429765|NCT00322868|144370641|SUPERIORITY_OR_OTHER|||||||0.55|TWO_SIDED||||||t-test, 1 sided|Paired t-test analysis of the intra-subject change in log10 sputum IL-6||||||0.55
72429766|NCT00322868|144370642|SUPERIORITY_OR_OTHER|||||||0.75|TWO_SIDED||||||t-test, 1 sided|Paired t-test analysis of the intra-subject change in log10 sputum IL-8||||||0.75
72429767|NCT01155726|144370667|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|||||TWO_SIDED|95.0|-2.2|1.4||||||Unmasked minus masked||1.4|-2.2|
72429768|NCT01155726|144370667|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.5|||||TWO_SIDED|95.0|-1.5|2.5||||||Unmasked minus masked||2.5|-1.5|
72429769|NCT01155726|144370667|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.1|||||TWO_SIDED|95.0|-0.1|2.2||||||Unmasked minus masked||2.2|-0.1|
72429770|NCT01155726|144370667|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.9|||||TWO_SIDED|95.0|0.2|3.5||||||Unmasked minus masked||3.5|0.2|
72429771|NCT01155726|144370667|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.1|||||TWO_SIDED|95.0|-3.3|1.2||||||Partial masked minus masked||1.2|-3.3|
72429772|NCT01155726|144370667|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|||||TWO_SIDED|95.0|-1.9|1.1||||||Partial masked minus masked||1.1|-1.9|
72429773|NCT01155726|144370667|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|||||TWO_SIDED|95.0|-2.9|2.7||||||Partial masked minus masked||2.7|-2.9|
72429774|NCT01155726|144370667|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.4|||||TWO_SIDED|95.0|-1.1|1.9||||||Partial masked minus masked||1.9|-1.1|
72429775|NCT02459587|144370668|SUPERIORITY|Survival analysis using start/stop counting method to identify time until event, structured to allow for multiple events per person. VCL contacts with and without suicide ideation were combined, due to low counts.|Hazard Ratio (HR)|1.24|STANDARD_ERROR_OF_MEAN|0.222||0.33|TWO_SIDED|95.0|0.8|1.92||2-tailed P-value above was calculated from type III test.|Regression, Cox|Model was structured to allow multiple events per person. No covariates.|Model was structured to allow multiple events per person. No covariates. HR based on parameter estimate = -0.218 (SEM=0.222)|||1.92|0.80|0.33
72429776|NCT02459587|144370669|SUPERIORITY|Survival analysis using start/stop counting method to identify time until event, structured to allow for multiple events per person.|Hazard Ratio (HR)|0.52|STANDARD_ERROR_OF_MEAN|0.153|<|0.0001|TWO_SIDED|95.0|0.38|0.7||All tests of significance were 2-tailed. P-value above is type III. No covariates.|Regression, Cox||Cox Proportional Hazards Model was structured to allow multiple events per person. No covariates. HR based on parameter estimate = -0.660 (SEM=0.153)|||0.70|0.38|<0.0001
72429777|NCT02459587|144370670|SUPERIORITY|Two binary variables were derived from Treatment Services Review responses to identify any general mental health service utilization, one binary variable for Baseline and another for any outpatient mental health service utilization at any time point in the 1 year follow-up period. The Baseline variable was included as a main-effects covariate.|Odds Ratio, log|1.146||||0.66|TWO_SIDED|95.0|0.604|2.176|||Regression, Logistic|Bivariate logistic, adjusted for (1) if any general outpatient mental heath visits at baseline (0) otherwise||||2.176|0.604|0.66
72429778|NCT02096081|144370677|NON_INFERIORITY_OR_EQUIVALENCE|"The analysis of response defined as the difference (D) in response rates between two treatment groups at 1 month was as follows: D = response rate in the incobotulinumtoxinA group minus the response rate in the onabotulinumtoxinA group. The hypothesis testing procedure to test the equivalence of the two products is as follows:~Ho (null): D ≤ -∆ OR D ≥ ∆ versus Ha (alternate): -∆ \< D \< ∆, where ∆ is the margin of equivalence = 0.15."|Difference in proportions of response|-3.5|||||TWO_SIDED|95.0|-7.5|0.6|||||If the confidence interval lies within the limits of ±0.15, then Ho is rejected in favor of Ha (i.e., equivalence of incobotulinumtoxinA and onabotulinumtoxinA can be concluded); otherwise, treatment equivalence cannot be concluded.|With assumptions of an alpha of 5%, an equivalence margin of 15% for each side, the real response rate expected as 90% for incobotulinumtoxinA and onabotulinumtoxinA at day 30 and a 1:1 allocation ratio, a total of 225 subjects were needed to achieve a statistical power of 90% in order to make an equivalence conclusion at day 30. Results are based on the Newcombe-Wilson confidence interval. To account for exclusions from the PPS of about 10%, approximately 250 subjects were enrolled.||0.6|-7.5|
72429779|NCT02096081|144370678|NON_INFERIORITY_OR_EQUIVALENCE|This secondary analysis was performed for exploratory purposes. The analysis of response defined as the difference (D) in response rates between two treatment groups at 2 months was as follows: D = response rate in the incobotulinumtoxinA group minus the response rate in the onabotulinumtoxinA group.|Difference in proportion of responders|-5.3|||||TWO_SIDED|95.0|-12.1|1.5|||||If the confidence interval lies within the limits of ±0.15, then both incobotulinumtoxinA and onabotulinumtoxinA have similar efficacy profiles.|The study was not powered for this secondary endpoint.||1.5|-12.1|
72429780|NCT02096081|144370679|NON_INFERIORITY_OR_EQUIVALENCE|This secondary analysis was performed for exploratory purposes. The analysis of response defined as the difference (D) in response rates between two treatment groups at 3 months was as follows: D = response rate in the incobotulinumtoxinA group minus the response rate in the onabotulinumtoxinA group.|Difference in proportion of responders|-0.5|||||TWO_SIDED|95.0|-10.6|9.6|||||If the confidence interval lies within the limits of ±0.15, then both incobotulinumtoxinA and onabotulinumtoxinA have similar efficacy profiles.|The study was not powered for this secondary endpoint.||9.6|-10.6|
72429781|NCT02096081|144370680|NON_INFERIORITY_OR_EQUIVALENCE|This secondary analysis was performed for exploratory purposes. The analysis of response defined as the difference (D) in response rates between two treatment groups at 4 months was as follows: D = response rate in the incobotulinumtoxinA group minus the response rate in the onabotulinumtoxinA group.|Difference in proportion of responders|-5.2|||||TWO_SIDED|95.0|-17.4|7.1|||||If the confidence interval lies within the limits of ±0.15, then both incobotulinumtoxinA and onabotulinumtoxinA have similar efficacy profiles.|The study was not powered for this secondary endpoint.||7.1|-17.4|
72429782|NCT02096081|144370681|NON_INFERIORITY_OR_EQUIVALENCE|This secondary analysis was performed for exploratory purposes. The analysis of response defined as the difference (D) in response rates between two treatment groups at 1 month was as follows: D = response rate in the incobotulinumtoxinA group minus the response rate in the onabotulinumtoxinA group.|Difference in proportion of responders|-2.7|||||TWO_SIDED|95.0|-8.5|3.2|||||If the confidence interval lies within the limits of ±0.15, then both incobotulinumtoxinA and onabotulinumtoxinA have similar efficacy profiles.|The study was not powered for this secondary endpoint.||3.2|-8.5|
72429783|NCT02096081|144370682|NON_INFERIORITY_OR_EQUIVALENCE|This secondary analysis was performed for exploratory purposes. The analysis of response defined as the difference (D) in response rates between two treatment groups at 2 months was as follows: D = response rate in the incobotulinumtoxinA group minus the response rate in the onabotulinumtoxinA group.|Difference in proportion of responders|-2.8|||||TWO_SIDED|95.0|-11.0|5.3|||||If the confidence interval lies within the limits of ±0.15, then both incobotulinumtoxinA and onabotulinumtoxinA have similar efficacy profiles.|The study was not powered for this secondary endpoint.||5.3|-11.0|
72429784|NCT02096081|144370683|NON_INFERIORITY_OR_EQUIVALENCE|This secondary analysis was performed for exploratory purposes. The analysis of response defined as the difference (D) in response rates between two treatment groups at 3 months was as follows: D = response rate in the incobotulinumtoxinA group minus the response rate in the onabotulinumtoxinA group.|Difference in proportion of responders|-1.5|||||TWO_SIDED|95.0|-12.4|9.5|||||If the confidence interval lies within the limits of ±0.15, then both incobotulinumtoxinA and onabotulinumtoxinA have similar efficacy profiles.|The study was not powered for this secondary endpoint.||9.5|-12.4|
72429785|NCT02096081|144370684|NON_INFERIORITY_OR_EQUIVALENCE|This secondary analysis was performed for exploratory purposes. The analysis of response defined as the difference (D) in response rates between two treatment groups at 4 months was as follows: D = response rate in the incobotulinumtoxinA group minus the response rate in the onabotulinumtoxinA group.|Difference in proportion of responders|-1.9|||||TWO_SIDED|95.0|-14.4|10.7|||||If the confidence interval lies within the limits of ±0.15, then both incobotulinumtoxinA and onabotulinumtoxinA have similar efficacy profiles.|The study was not powered for this secondary endpoint.||10.7|-14.4|
72429786|NCT03088137|144370726|EQUIVALENCE|Study power of at least 80% at a significance level (alpha error) 5% and a pre-determined clinical equivalence margin of +/- 3.4 oocytes for the relevant population.|Mean Difference (Final Values)|0.546|STANDARD_DEVIATION|1.297||0.002|TWO_SIDED|95.0|-2.026|3.116|||Wilcoxon (Mann-Whitney)|||||3.116|-2.026|0.002
72429787|NCT03088137|144370727|SUPERIORITY||Mean Difference (Final Values)|0.709|STANDARD_DEVIATION|1.067||0.806|TWO_SIDED|95.0|-1.405|2.824|||Wilcoxon (Mann-Whitney)|||||2.824|-1.405|0.806
72429788|NCT03088137|144370728|SUPERIORITY||Mean Difference (Final Values)|0.218|STANDARD_DEVIATION|1.129||0.617|TWO_SIDED|95.0|-2.455|2.019|||Wilcoxon (Mann-Whitney)|||||2.019|-2.455|0.617
72429789|NCT03088137|144370729|SUPERIORITY||Mean Difference (Final Values)|0.636|STANDARD_DEVIATION|1.19||0.445|TWO_SIDED|95.0|-2.995|1.723|||Wilcoxon (Mann-Whitney)|||||1.723|-2.995|0.445
72363294|NCT00674817|144237575|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|6.588|STANDARD_ERROR_OF_MEAN|1.3932|||TWO_SIDED|95.0|3.839|9.336||||||GSK961081 400 mcg Plus SAL versus GSK961081 400 mcg plus Placebo during 0-4 hours||9.336|3.839|
72363295|NCT00674817|144237575|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.255|STANDARD_ERROR_OF_MEAN|1.3725|||TWO_SIDED|95.0|-1.453|3.962||||||GSK961081 400 mcg Plus IPR versus GSK961081 400 mcg plus Placebo during 0-4 hours||3.962|-1.453|
72363296|NCT00674817|144237575|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|6.985|STANDARD_ERROR_OF_MEAN|1.396|||TWO_SIDED|95.0|4.231|9.738||||||GSK961081 1200 mcg Plus SAL versus GSK961081 1200 mcg plus Placebo during 0-4 hours||9.738|4.231|
72363297|NCT00674817|144237575|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.255|STANDARD_ERROR_OF_MEAN|1.4077|||TWO_SIDED|95.0|-0.522|5.031||||||GSK961081 1200 mcg Plus IPR versus GSK961081 1200 mcg plus Placebo during 0-4 hours||5.031|-0.522|
72363298|NCT00674817|144237575|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.121|STANDARD_ERROR_OF_MEAN|1.2464|||TWO_SIDED|95.0|1.662|6.58||||||GSK961081 400 mcg Plus SAL versus maximal GSK961081 400 mcg plus Placebo during 0-27 hours||6.580|1.662|
72363299|NCT00674817|144237575|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.28|STANDARD_ERROR_OF_MEAN|1.2278|||TWO_SIDED|95.0|-2.142|2.703||||||GSK961081 400 mcg Plus IPR versus GSK961081 400 mcg plus Placebo during 0-27 hours||2.703|-2.142|
72363300|NCT00674817|144237575|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.266|STANDARD_ERROR_OF_MEAN|1.249|||TWO_SIDED|95.0|1.802|6.729||||||GSK961081 1200 mcg Plus SAL versus GSK961081 1200 mcg plus Placebo during 0-27 hours||6.729|1.802|
72363301|NCT00674817|144237575|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.621|STANDARD_ERROR_OF_MEAN|1.2593|||TWO_SIDED|95.0|-0.863|4.106||||||GSK961081 1200 mcg Plus IPR versus GSK961081 1200 mcg plus Placebo during 0-27 hours||4.106|-0.863|
72363302|NCT00674817|144237576|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.094|STANDARD_ERROR_OF_MEAN|0.83|||TWO_SIDED|95.0|2.456|5.732||||||GSK961081 400 mcg plus SAL versus GSK961081 400 mcg plus Placebo during 0-4 hours||5.732|2.456|
72363303|NCT00674817|144237576|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.646|STANDARD_ERROR_OF_MEAN|0.8172|||TWO_SIDED|95.0|-0.967|2.258||||||GSK961081 400 mcg Plus IPR versus GSK961081 400 mcg plus Placebo during 0-4 hours||2.258|-0.967|
72363304|NCT00674817|144237576|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.98|STANDARD_ERROR_OF_MEAN|0.8395|||TWO_SIDED|95.0|2.324|5.636||||||GSK961081 1200 mcg Plus SAL versus GSK961081 1200 mcg plus Placebo during 0-4 hours||5.636|2.324|
72363305|NCT00674817|144237576|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.934|STANDARD_ERROR_OF_MEAN|0.846|||TWO_SIDED|95.0|-0.735|2.603||||||GSK961081 1200 mcg Plus IPR versus GSK961081 1200 mcg plus Placebo during 0-4 hours||2.603|-0.735|
72363306|NCT00674817|144237577|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.836|STANDARD_ERROR_OF_MEAN|1.8168|||TWO_SIDED|95.0|-5.42|1.748||||||GSK961081 400 mcg Plus SAL versus GSK961081 400 mcg plus Placebo during 0-4 hours||1.748|-5.420|
72363307|NCT00674817|144237577|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.599|STANDARD_ERROR_OF_MEAN|1.7809|||TWO_SIDED|95.0|-2.914|4.113||||||GSK961081 400 mcg Plus IPR versus GSK961081 400 mcg plus Placebo during 0-4 hours||4.113|-2.914|
72363308|NCT00674817|144237577|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.324|STANDARD_ERROR_OF_MEAN|1.8174|||TWO_SIDED|95.0|-3.261|3.909||||||GSK961081 1200 mcg Plus SAL versus GSK961081 1200 mcg plus Placebo during 0-4 hours||3.909|-3.261|
72363309|NCT00674817|144237577|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.182|STANDARD_ERROR_OF_MEAN|1.8242|||TWO_SIDED|95.0|-5.781|1.416||||||GSK961081 1200 mcg Plus IPR versus GSK961081 1200 mcg plus Placebo during 0-4 hours||1.416|-5.781|
72363310|NCT00674817|144237577|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.266|STANDARD_ERROR_OF_MEAN|1.7723|||TWO_SIDED|95.0|-6.762|0.23||||||GSK961081 400 mcg Plus SAL versus GSK961081 400 mcg plus Placebo during 0-27 hours||0.230|-6.762|
72363311|NCT00674817|144237577|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.077|STANDARD_ERROR_OF_MEAN|1.7361|||TWO_SIDED|95.0|-3.502|3.348||||||GSK961081 400 mcg Plus IPR versus GSK961081 400 mcg plus Placebo during 0-27 hours||3.348|-3.502|
72363312|NCT00674817|144237577|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.827|STANDARD_ERROR_OF_MEAN|1.7743|||TWO_SIDED|95.0|-1.673|5.327||||||GSK961081 1200 mcg Plus SAL versus GSK961081 1200 mcg plus Placebo during 0-27 hours||5.327|-1.673|
72429790|NCT03088137|144370730|SUPERIORITY|||||||0.623|||||||ANOVA|||||||0.623
72429791|NCT03088137|144370731|SUPERIORITY||Mean Difference (Final Values)|14.9|STANDARD_DEVIATION|49.8||0.488|TWO_SIDED|95.0|-83.9|113.6|||Wilcoxon (Mann-Whitney)|||||113.6|-83.9|0.488
72429792|NCT03088137|144370732|SUPERIORITY||Mean Difference (Final Values)|0.018|STANDARD_DEVIATION|0.201||0.629|TWO_SIDED|95.0|-0.379|0.416|||Wilcoxon (Mann-Whitney)|||||0.416|-0.379|0.629
72429793|NCT03088137|144370733|SUPERIORITY|||||||0.644|||||||Wilcoxon (Mann-Whitney)|||||||0.644
72429794|NCT03088137|144370736|SUPERIORITY||Mean Difference (Final Values)|-2.0||||0.833|TWO_SIDED|95.0|-21.0|17.0|||Chi-squared|||95% confidence intervals (CIs) of point estimates were calculated using the exact binomial distribution (Clopper-Pearson method) for proportions.||17.0|-21.0|0.833
72429795|NCT03088137|144370737|SUPERIORITY||Mean Difference (Final Values)|-0.62||||0.507|TWO_SIDED|95.0|-24.3|11.9|||Chi-squared|||95% confidence intervals (CIs) of point estimates were calculated using the exact binomial distribution (Clopper-Pearson method) for proportions.||11.9|-24.3|0.507
72429796|NCT00918749|144370742|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.598|STANDARD_ERROR_OF_MEAN|4.215||0.3946|TWO_SIDED|90.0|-10.568|3.372|||ANOVA|Fixed effects for treatment and center.||A two group t-test with a 0.100 one-sided significance level would have 96% power to detect the difference between a risedronate 150 mg IRBB mean, µ1, of -46.000 and a risedronate 75 mg DRFB mean, µ2, of -29.900 (a difference in means of -16.100), assuming that the common SD was 28.000, with sample sizes of 60 per group, respectively. Estimates were based on Study 2005107 (35 mg DR once a week Phase 2 study). The sample size calculation was not adjusted for multiplicity.||3.372|-10.568|0.3946
72429797|NCT00918749|144370742|SUPERIORITY_OR_OTHER||LS Mean Difference|-12.197|STANDARD_ERROR_OF_MEAN|4.241||0.0045|TWO_SIDED|90.0|-19.208|-5.185|||ANOVA|Fixed effects for treatment and center.||||-5.185|-19.208|0.0045
72429798|NCT00918749|144370743|SUPERIORITY_OR_OTHER||LS Mean Difference|4.765|STANDARD_ERROR_OF_MEAN|4.952||0.3372|TWO_SIDED|90.0|-3.421|12.952|||ANOVA|Fixed effects for treatment and center.||||12.952|-3.421|0.3372
72429799|NCT00918749|144370743|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.218|STANDARD_ERROR_OF_MEAN|4.966||0.965|TWO_SIDED|90.0|-8.427|7.991|||ANOVA|Fixed effects for treatment and center.||||7.991|-8.427|0.9650
72429800|NCT00918749|144370744|SUPERIORITY_OR_OTHER||LS Mean Difference|0.388|STANDARD_ERROR_OF_MEAN|4.269||0.9276|TWO_SIDED|90.0|-6.67|7.447|||ANOVA|Fixed effects for treatment and center.||||7.447|-6.670|0.9276
72429801|NCT00918749|144370744|SUPERIORITY_OR_OTHER||LS Mean Difference|-10.787|STANDARD_ERROR_OF_MEAN|4.313||0.0133|TWO_SIDED|90.0|-17.917|-3.657|||ANOVA|Fixed effects for treatment and center.||||-3.657|-17.917|0.0133
72429802|NCT00918749|144370745|SUPERIORITY_OR_OTHER||LS Mean Difference|14.528|STANDARD_ERROR_OF_MEAN|9.28||0.1192|TWO_SIDED|90.0|-0.813|29.868|||ANOVA|Fixed effects for treatment and center.||||29.868|-0.813|0.1192
72429803|NCT00918749|144370745|SUPERIORITY_OR_OTHER||LS Mean Difference|14.215|STANDARD_ERROR_OF_MEAN|9.343||0.1298|TWO_SIDED|90.0|-1.23|29.659|||ANOVA|Fixed effects for treatment and center.||||29.659|-1.230|0.1298
72429804|NCT00918749|144370746|SUPERIORITY_OR_OTHER||LS Mean Difference|1.119|STANDARD_ERROR_OF_MEAN|6.093||0.8546|TWO_SIDED|90.0|-8.956|11.193|||ANOVA|Fixed effects for treatment and center.||||11.193|-8.956|0.8546
72429805|NCT00918749|144370746|SUPERIORITY_OR_OTHER||LS Mean Difference|-7.393|STANDARD_ERROR_OF_MEAN|6.126||0.2291|TWO_SIDED|90.0|-17.522|2.737|||ANOVA|Fixed effects for treatment and center.||||2.737|-17.522|0.2291
72429806|NCT00918749|144370747|SUPERIORITY_OR_OTHER||LS Mean Difference|5.505|STANDARD_ERROR_OF_MEAN|9.046||0.5436|TWO_SIDED|90.0|-9.452|20.462|||ANOVA|Fixed effects for treatment and center.||||20.462|-9.452|0.5436
72429807|NCT00918749|144370747|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.914|STANDARD_ERROR_OF_MEAN|9.1||0.9201|TWO_SIDED|90.0|-15.959|14.132|||ANOVA|Fixed effects for treatment and center.||||14.132|-15.959|0.9201
72429808|NCT00918749|144370748|SUPERIORITY_OR_OTHER||LS Mean Difference|3.108|STANDARD_ERROR_OF_MEAN|4.052||0.444|TWO_SIDED|90.0|-3.59|9.807|||ANOVA|Fixed effects for treatment and center.||||9.807|-3.590|0.4440
72429809|NCT00918749|144370748|SUPERIORITY_OR_OTHER||LS Mean Difference|4.842|STANDARD_ERROR_OF_MEAN|4.063||0.2349|TWO_SIDED|90.0|-1.874|11.559|||ANOVA|Fixed effects for treatment and center.||||11.559|-1.874|0.2349
72429810|NCT00918749|144370749|SUPERIORITY_OR_OTHER||LS Mean Difference|4.966|STANDARD_ERROR_OF_MEAN|4.327||0.2527|TWO_SIDED|90.0|-2.189|12.12|||ANOVA|Fixed effects for treatment and center.||||12.120|-2.189|0.2527
72429811|NCT00918749|144370749|SUPERIORITY_OR_OTHER||LS Mean Difference|4.926|STANDARD_ERROR_OF_MEAN|4.371||0.2613|TWO_SIDED|90.0|-2.301|12.153|||ANOVA|Fixed effects for treatment and center.||||12.153|-2.301|0.2613
72429812|NCT00918749|144370750|SUPERIORITY_OR_OTHER||LS Mean Difference|1.269|STANDARD_ERROR_OF_MEAN|4.16||0.7606|TWO_SIDED|90.0|-5.609|8.148|||ANOVA|Fixed effects for treatment and center.||||8.148|-5.609|0.7606
72429813|NCT00918749|144370750|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.825|STANDARD_ERROR_OF_MEAN|4.185||0.5006|TWO_SIDED|90.0|-9.744|4.095|||ANOVA|Fixed effects for treatment and center.||||4.095|-9.744|0.5006
72429814|NCT03055832|144370783|NON_INFERIORITY|"This study provides a combined power of co-primary endpoints of 88% given the following primary endpoint assumptions:~* MGS non-inferiority delta of 5 points and standard deviation of 8 points provides power of 93.9%~* TBT non-inferiority delta of 2.5 seconds and standard deviation of 4 seconds, provides a TBT primary endpoint power of 93.9%~* Power that both endpoitns are significant, assuming independence was 0.939\^2 = 0.882 or 88.2% power."|Mean Difference (Net)|-0.13|STANDARD_ERROR_OF_MEAN|1.88|||TWO_SIDED|95.0|-3.82|3.56||||||||3.56|-3.82|
72429815|NCT03055832|144370784|NON_INFERIORITY|"This study provides a combined power of co-primary endpoints of 88% given the following primary endpoint assumptions:~* MGS non-inferiority delta of 5 points and standard deviation of 8 points provides power of 93.9%~* TBT non-inferiority delta of 2.5 seconds and standard deviation of 4 seconds, provides a TBT primary endpoint power of 93.9%~* Power that both endpoitns are significant, assuming independence was 0.939\^2 = 0.882 or 88.2% power."|Mean Difference (Net)|0.1|STANDARD_ERROR_OF_MEAN|0.54|||TWO_SIDED|95.0|-0.97|1.16||||||||1.16|-0.97|
72429816|NCT03055832|144370785|OTHER|A formal hypothesis was not proposed for this endpoint and therefore a power calculation was not performed. A Fisher's Exact test was performed post hoc to determine if a significant difference existed between the two arms.||||||0.12|||||||Fisher Exact|||||||0.12
72429817|NCT03055832|144370786|NON_INFERIORITY|A standard deviation of 14 was assumed based on pilot data and the non-inferiority delta was set to 7. The chosen sample size and alpha = 0.025 provides 80% power for this endpoint|Mean Difference (Net)|-3.08|STANDARD_ERROR_OF_MEAN|2.89|||TWO_SIDED|95.0|-8.75|2.59||||||All questions||2.59|-8.75|
72429818|NCT01163149|144370802|SUPERIORITY|If p-values were less than 0.05 and the Hodges-Lehman-Sen estimate favored asfotase alfa (eg, it had a negative sign indicating the between-group differences in change from Baseline favored treated patients), then superiority over control was claimed.|Hodges-Lehman-Sen|-302.05||||0.0285|TWO_SIDED|95.0|-626.4|-59.2||Two-sided with p-value threshold \<0.05 for statistical significance|Wilcoxon rank-sum|||PLP Change from Baseline to Week 24||-59.20|-626.40|0.0285
72368535|NCT02304367|144247141|OTHER|||||||0.047|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline BALP.||Week 48||||0.047
72368536|NCT02304367|144247141|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline BALP.||Week 96||||< 0.001
72368537|NCT02304367|144247141|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline BALP.||Week 144||||< 0.001
72368538|NCT02304367|144247141|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline BALP.||Week 168||||< 0.001
72368539|NCT02304367|144247141|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline BALP.||Week 192||||< 0.001
72368540|NCT02304367|144247141|OTHER|||||||0.17|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline BALP.||Week 216||||0.170
72368541|NCT02304367|144247141|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline BALP.||Week 240||||< 0.001
72368542|NCT02304367|144247142|OTHER|||||||0.09|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline CTx.||Week 24||||0.090
72368543|NCT02304367|144247142|OTHER|||||||0.226|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline CTx.||Week 48||||0.226
72368544|NCT02304367|144247142|OTHER|||||||0.918|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline CTx.||Week 96||||0.918
72368545|NCT02304367|144247142|OTHER|||||||0.616|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline CTx.||Week 144||||0.616
72368546|NCT02304367|144247142|OTHER|||||||0.041|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline CTx.||Week 168||||0.041
72368547|NCT02304367|144247142|OTHER|||||||0.002|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline CTx.||Week 192||||0.002
72368548|NCT02304367|144247142|OTHER|||||||0.137|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline CTx.||Week 216||||0.137
72368549|NCT02304367|144247142|OTHER|||||||0.368|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline CTx.||Week 240||||0.368
72368550|NCT02304367|144247143|OTHER|||||||0.018|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline CTx.||Week 24||||0.018
72368551|NCT02304367|144247143|OTHER|||||||0.133|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline CTx.||Week 48||||0.133
72368552|NCT02304367|144247143|OTHER|||||||0.321|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline CTx.||Week 96||||0.321
72368553|NCT02304367|144247143|OTHER|||||||0.218|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline CTx.||Week 144||||0.218
72368554|NCT02304367|144247143|OTHER|||||||0.788|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline CTx.||Week 168||||0.788
72368555|NCT02304367|144247143|OTHER|||||||0.156|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline CTx.||Week 192||||0.156
72368556|NCT02304367|144247143|OTHER|||||||0.155|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline CTx.||Week 216||||0.155
72368557|NCT02304367|144247143|OTHER|||||||0.58|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline CTx.||Week 240||||0.580
72368558|NCT02304367|144247144|OTHER|||||||0.002|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline P1NP.||Week 24||||0.002
72368559|NCT02304367|144247144|OTHER|||||||0.273|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline P1NP.||Week 48||||0.273
72368560|NCT02304367|144247144|OTHER|||||||0.469|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline P1NP.||Week 96||||0.469
72368561|NCT02304367|144247144|OTHER|||||||0.828|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline P1NP.||Week 144||||0.828
72368562|NCT02304367|144247144|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline P1NP.||Week 168||||< 0.001
72368563|NCT02304367|144247144|OTHER|||||||0.141|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline P1NP.||Week 192||||0.141
72368564|NCT02304367|144247144|OTHER|||||||0.606|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline P1NP.||Week 216||||0.606
72368565|NCT02304367|144247144|OTHER|||||||0.907|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline P1NP.||Week 240||||0.907
72368566|NCT02304367|144247145|OTHER|||||||0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline P1NP.||Week 24||||0.001
72368567|NCT02304367|144247145|OTHER|||||||0.149|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline P1NP.||Week 48||||0.149
72368568|NCT02304367|144247145|OTHER|||||||0.372|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline P1NP.||Week 96||||0.372
72368569|NCT02304367|144247145|OTHER|||||||0.116|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline P1NP.||Week 144||||0.116
72368570|NCT02304367|144247145|OTHER|||||||0.013|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline P1NP.||Week 168||||0.013
72429819|NCT01163149|144370803|SUPERIORITY|If p-values were less than 0.05 and the Hodges-Lehman-Sen estimate favored asfotase alfa (eg, it had a negative sign indicating the between-group differences in change from Baseline favored treated patients), then superiority over control was claimed.|Hodges-Lehman-Sen|-1.825||||0.0715|TWO_SIDED|95.0|-3.21|0.23||Two-sided with p-value threshold \<0.05 for statistical significance|Wilcoxon rank-sum||Estimate and exact confidence interval are from Hodges-Lehmann-Sen method for location shift in distribution between the treatment group and the control group.|PPi Change from Baseline to Week 24||0.230|-3.210|0.0715
72363313|NCT00674817|144237577|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.232|STANDARD_ERROR_OF_MEAN|1.78|||TWO_SIDED|95.0|-4.743|2.279||||||GSK961081 1200 mcg Plus IPR versus GSK961081 1200 mcg plus Placebo during 0-27 hours||2.279|-4.743|
72363314|NCT00674817|144237577|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.394|STANDARD_ERROR_OF_MEAN|1.3084|||TWO_SIDED|95.0|-3.976|1.187||||||GSK961081 400 mcg Plus SAL versus GSK961081 400 mcg plus Placebo during 0-4 hours (WMC)||1.187|-3.976|
72363315|NCT00674817|144237577|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.181|STANDARD_ERROR_OF_MEAN|1.2819|||TWO_SIDED|95.0|-1.348|3.71||||||GSK961081 400 mcg Plus IPR versus GSK961081 400 mcg plus Placebo during 0-4 hours (WMC)||3.710|-1.348|
72363316|NCT00674817|144237577|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.106|STANDARD_ERROR_OF_MEAN|1.3201|||TWO_SIDED|95.0|-2.498|2.71||||||GSK961081 1200 mcg Plus SAL versus GSK961081 1200 mcg plus Placebo during 0-4 hours (WMC)||2.710|-2.498|
72363317|NCT00674817|144237577|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.713|STANDARD_ERROR_OF_MEAN|1.3241|||TWO_SIDED|95.0|-3.325|1.899||||||GSK961081 1200 mcg Plus IPR versus GSK961081 1200 mcg plus Placebo during 0-4 hours (WMC)||1.899|-3.325|
72363318|NCT00674817|144237578|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.561|STANDARD_ERROR_OF_MEAN|1.2351|||TWO_SIDED|95.0|-2.997|1.876||||||GSK961081 400 mcg Plus SAL versus GSK961081 400 mcg plus Placebo during 0-4 hours||1.876|-2.997|
72363319|NCT00674817|144237578|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.705|STANDARD_ERROR_OF_MEAN|1.2125|||TWO_SIDED|95.0|-0.687|4.097||||||GSK961081 400 mcg Plus IPR versus GSK961081 400 mcg plus Placebo during 0-4 hours||4.097|-0.687|
72363320|NCT00674817|144237578|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.337|STANDARD_ERROR_OF_MEAN|1.2341|||TWO_SIDED|95.0|-3.771|1.098||||||GSK961081 1200 mcg Plus SAL versus GSK961081 1200 mcg plus Placebo during 0-4 hours||1.098|-3.771|
72363321|NCT00674817|144237578|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.067|STANDARD_ERROR_OF_MEAN|1.2416|||TWO_SIDED|95.0|-3.516|1.382||||||GSK961081 1200 mcg Plus IPR versus GSK961081 1200 mcg plus Placebo during 0-4 hours||1.382|-3.516|
72363322|NCT00674817|144237578|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.376|STANDARD_ERROR_OF_MEAN|1.0997|||TWO_SIDED|95.0|-2.545|1.794||||||GSK961081 400 mcg Plus SAL versus GSK961081 400 mcg plus Placebo during 0-27 hours||1.794|-2.545|
72363323|NCT00674817|144237578|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.54|STANDARD_ERROR_OF_MEAN|1.0786|||TWO_SIDED|95.0|-1.588|2.668||||||GSK961081 400 mcg Plus IPR versus GSK961081 400 mcg plus Placebo during 0-27 hours||2.668|-1.588|
72363324|NCT00674817|144237578|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.016|STANDARD_ERROR_OF_MEAN|1.0999|||TWO_SIDED|95.0|-2.185|2.154||||||GSK961081 1200 mcg Plus SAL versus GSK961081 1200 mcg plus Placebo during 0-27 hours||2.154|-2.185|
72363325|NCT00674817|144237578|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.466|STANDARD_ERROR_OF_MEAN|1.1058|||TWO_SIDED|95.0|-1.715|2.648||||||GSK961081 1200 mcg Plus IPR versus GSK961081 1200 mcg plus Placebo during 0-27 hours||2.648|-1.715|
72363326|NCT00674817|144237578|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.18|STANDARD_ERROR_OF_MEAN|0.881|||TWO_SIDED|95.0|-2.918|0.559||||||GSK961081 400 mcg Plus SAL versus GSK961081 400 mcg plus Placebo during 0-4 hours (WMC)||0.559|-2.918|
72363327|NCT00674817|144237578|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.876|STANDARD_ERROR_OF_MEAN|0.8644|||TWO_SIDED|95.0|-0.829|2.582||||||GSK961081 400 mcg Plus IPR versus GSK961081 400 mcg plus Placebo during 0-4 hours (WMC)||2.582|-0.829|
72363328|NCT00674817|144237578|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.809|STANDARD_ERROR_OF_MEAN|0.8882|||TWO_SIDED|95.0|-2.561|0.944||||||GSK961081 1200 mcg Plus SAL versus GSK961081 1200 mcg plus Placebo during 0-4 hours (WMC)||0.944|-2.561|
72363329|NCT00674817|144237578|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.36|STANDARD_ERROR_OF_MEAN|0.8929|||TWO_SIDED|95.0|-2.122|1.401||||||GSK961081 1200 mcg Plus IPR versus GSK961081 1200 mcg plus Placebo during 0-4 hours (WMC)||1.401|-2.122|
72363330|NCT00674817|144237579|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.53|STANDARD_ERROR_OF_MEAN|0.2352|||TWO_SIDED|95.0|0.066|0.994||||||GSK961081 400 mcg Plus SAL versus GSK961081 400 mcg plus Placebo during 0-4 hours||0.994|0.066|
72363331|NCT00674817|144237579|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.388|STANDARD_ERROR_OF_MEAN|0.2318|||TWO_SIDED|95.0|-0.069|0.846||||||GSK961081 400 mcg Plus IPR versus GSK961081 400 mcg plus Placebo during 0-4 hours||0.846|-0.069|
72363332|NCT00674817|144237579|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.309|STANDARD_ERROR_OF_MEAN|0.2363|||TWO_SIDED|95.0|-0.157|0.775||||||GSK961081 1200 mcg Plus SAL versus GSK961081 1200 mcg plus Placebo during 0-4 hours||0.775|-0.157|
72363333|NCT00674817|144237579|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.309|STANDARD_ERROR_OF_MEAN|0.2392|||TWO_SIDED|95.0|-0.163|0.78||||||GSK961081 1200 mcg Plus IPR versus GSK961081 1200 mcg plus Placebo during 0-4 hours||0.780|-0.163|
72363334|NCT00674817|144237579|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.874|STANDARD_ERROR_OF_MEAN|0.3099|||TWO_SIDED|95.0|0.262|1.485||||||GSK961081 400 mcg Plus SAL versus GSK961081 400 mcg plus Placebo during 0-27 hours||1.485|0.262|
72363335|NCT00674817|144237579|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.053|STANDARD_ERROR_OF_MEAN|0.3056|||TWO_SIDED|95.0|-0.656|0.55||||||GSK961081 400 mcg Plus IPR versus GSK961081 400 mcg plus Placebo during 0-27 hours||0.550|-0.656|
72363336|NCT00674817|144237579|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.829|STANDARD_ERROR_OF_MEAN|0.3112|||TWO_SIDED|95.0|0.215|1.443||||||GSK961081 1200 mcg Plus SAL versus GSK961081 1200 mcg plus Placebo during 0-27 hours||1.443|0.215|
72363337|NCT00674817|144237579|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.567|STANDARD_ERROR_OF_MEAN|0.3151|||TWO_SIDED|95.0|-0.054|1.189||||||GSK961081 1200 mcg Plus IPR versus GSK961081 1200 mcg plus Placebo during 0-27 hours||1.189|-0.054|
72363338|NCT00674817|144237579|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.312|STANDARD_ERROR_OF_MEAN|0.1021|||TWO_SIDED|95.0|0.11|0.513||||||GSK961081 400 mcg Plus SAL versus GSK961081 400 mcg plus Placebo during 0-4 hours (WMC)||0.513|0.110|
72363339|NCT00674817|144237579|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.173|STANDARD_ERROR_OF_MEAN|0.1006|||TWO_SIDED|95.0|-0.025|0.372||||||GSK961081 400 mcg Plus IPR versus maximum GSK961081 400 mcg plus Placebo during 0-4 hours (WMC)||0.372|-0.025|
72363340|NCT00674817|144237579|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.21|STANDARD_ERROR_OF_MEAN|0.1035|||TWO_SIDED|95.0|0.006|0.414||||||GSK961081 1200 mcg Plus SAL versus GSK961081 1200 mcg plus Placebo during 0-4 hours (WMC)||0.414|0.006|
72363341|NCT00674817|144237579|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.104|STANDARD_ERROR_OF_MEAN|0.1047|||TWO_SIDED|95.0|-0.103|0.311||||||GSK961081 1200 mcg Plus IPR versus GSK961081 1200 mcg plus Placebo during 0-4 hours (WMC)||0.311|-0.103|
72363342|NCT00674817|144237580|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.177|STANDARD_ERROR_OF_MEAN|0.0503|||TWO_SIDED|95.0|-0.276|-0.078||||||GSK961081 400 mcg Plus SAL versus GSK961081 400 mcg plus Placebo during 0-4 hours||-0.078|-0.276|
72363343|NCT00674817|144237580|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.001|STANDARD_ERROR_OF_MEAN|0.049|||TWO_SIDED|95.0|-0.096|0.097||||||GSK961081 400 mcg Plus IPR versus GSK961081 400 mcg plus Placebo during 0-4 hours||0.097|-0.096|
72363344|NCT00674817|144237580|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.076|STANDARD_ERROR_OF_MEAN|0.0498|||TWO_SIDED|95.0|-0.174|0.022||||||SK961081 1200 mcg Plus SAL versus GSK961081 1200 mcg plus Placebo during 0-4 hours||0.022|-0.174|
72363345|NCT00674817|144237580|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.028|STANDARD_ERROR_OF_MEAN|0.0507|||TWO_SIDED|95.0|-0.128|0.072||||||GSK961081 1200 mcg Plus IPR versus GSK961081 1200 mcg plus Placebo during 0-4 hours||0.072|-0.128|
72363346|NCT00674817|144237580|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.166|STANDARD_ERROR_OF_MEAN|0.0493|||TWO_SIDED|95.0|-0.263|-0.069||||||GSK961081 400 mcg Plus SAL versus GSK961081 400 mcg plus Placebo during 0-27 hours||-0.069|-0.263|
72363347|NCT00674817|144237580|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.057|STANDARD_ERROR_OF_MEAN|0.0481|||TWO_SIDED|95.0|-0.152|0.038||||||GSK961081 400 mcg Plus IPR versus GSK961081 400 mcg plus Placebo during 0-27 hours||0.038|-0.152|
72363348|NCT00674817|144237580|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.171|STANDARD_ERROR_OF_MEAN|0.0489|||TWO_SIDED|95.0|-0.267|-0.075||||||GSK961081 1200 mcg Plus SAL versus GSK961081 1200 mcg plus Placebo during 0-27 hours||-0.075|-0.267|
72363349|NCT00674817|144237580|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.009|STANDARD_ERROR_OF_MEAN|0.0498|||TWO_SIDED|95.0|-0.108|0.089||||||GSK961081 1200 mcg Plus IPR versus GSK961081 1200 mcg plus Placebo during 0-27 hours||0.089|-0.108|
72363350|NCT00674817|144237580|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.108|STANDARD_ERROR_OF_MEAN|0.0522|||TWO_SIDED|95.0|-0.211|-0.005||||||GSK961081 400 mcg Plus SAL versus GSK961081 400 mcg plus Placebo during 0-4 hours (WMC)||-0.005|-0.211|
72363351|NCT00674817|144237580|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.014|STANDARD_ERROR_OF_MEAN|0.0509|||TWO_SIDED|95.0|-0.087|0.114||||||GSK961081 400 mcg Plus IPR versus GSK961081 400 mcg plus Placebo during 0-4 hours||0.114|-0.087|
72363352|NCT00674817|144237580|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.077|STANDARD_ERROR_OF_MEAN|0.052|||TWO_SIDED|95.0|-0.18|0.026||||||GSK961081 1200 mcg Plus SAL GSK961081 1200 mcg plus Placebo during 0-4 hours (WMC)||0.026|-0.180|
72363353|NCT00674817|144237580|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.024|STANDARD_ERROR_OF_MEAN|0.0529|||TWO_SIDED|95.0|-0.129|0.08||||||GSK961081 1200 mcg Plus IPR versus GSK961081 1200 mcg plus Placebo during 0-4 hours (WMC)||0.080|-0.129|
72363354|NCT03697252|144237586|SUPERIORITY||LS mean difference|-11.56|||<|0.0001|TWO_SIDED|95.0|-16.07|-7.05|||Mixed model for repeated measures||||Statistics are from a mixed model for repeated measures (MMRM). The model includes the treatment group (KarXT or placebo), visit, and the interaction between the treatment group and visit as fixed factors, and baseline PANSS total score, site, age, and gender as covariates. An unstructured covariance matrix is used to model the correlation among repeated measurements and the denominator degrees of freedom are computed using the Kenward-Roger method.|-7.05|-16.07|<0.0001
72363355|NCT03697252|144237588|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Comparison of KarXT and Placebo at Week 5||||<0.001
72363356|NCT02435212|144237634|SUPERIORITY||Least squares mean|2.58|STANDARD_ERROR_OF_MEAN|2.803||0.3598|TWO_SIDED|95.0|-2.99|8.15|||ANCOVA|||||8.15|-2.99|0.3598
72363357|NCT02435212|144237635|SUPERIORITY||Least squares mean|176.36|STANDARD_ERROR_OF_MEAN|153.933||0.2546|TWO_SIDED|95.0|-129.0|481.72|||ANCOVA|||||481.72|-129.00|0.2546
72429820|NCT01163149|144370805|SUPERIORITY||Hodges-Lehmann-Sen|-0.91||||0.3301|TWO_SIDED|95.0|-3.32|1.78||Two-sided with p-value threshold \<0.05 for statistical significance|Wilcoxon rank-sum|||Hip Total BMC Change from Baseline to Week 24||1.780|-3.320|0.3301
72363358|NCT00135226|144237666|OTHER||Rate Ratio|0.88||||0.01|TWO_SIDED|95.0|0.79|0.97|||Log Rank|||||0.97|0.79|0.01
72363359|NCT00135226|144237666|OTHER||Rate Ratio|0.97||||0.55|TWO_SIDED|95.0|0.87|1.08|||Log Rank|||||1.08|0.87|0.55
72363360|NCT00135226|144237667|OTHER||Rate Ratio|1.29||||0.003|TWO_SIDED|95.0|1.09|1.52|||Log Rank|||||1.52|1.09|0.003
72363361|NCT00135226|144237668|OTHER||Rate Ratio|0.88|||||TWO_SIDED|95.0|0.8|0.97||||||||0.97|0.80|
72363362|NCT00135226|144237668|OTHER||Rate Ratio|1.0|||||TWO_SIDED|95.0|0.91|1.09||||||||1.09|0.91|
72363363|NCT00135226|144237669|OTHER||Rate Ratio|0.99|||||TWO_SIDED|95.0|0.8|1.24||||||||1.24|0.80|
72363364|NCT00135226|144237670|OTHER||Rate Ratio|0.94|||||TWO_SIDED|95.0|0.85|1.04||||||||1.04|0.85|
72363365|NCT00135226|144237670|OTHER||Risk Ratio|0.95|||||TWO_SIDED|95.0|0.86|1.05||||||||1.05|0.86|
72363366|NCT00135226|144237671|OTHER||Rate Ratio|0.86|||||TWO_SIDED|95.0|0.66|1.12||||||||1.12|0.66|
72363367|NCT00135226|144237671|OTHER||Rate ratio|0.79|||||TWO_SIDED|95.0|0.61|1.02||||||||1.02|0.61|
72363368|NCT00135226|144237672|OTHER||Rate Ratio|1.12|||||TWO_SIDED|95.0|0.7|1.77||||||||1.77|0.7|
72363369|NCT00135226|144237672|OTHER||Rate Ratio|0.94|||||TWO_SIDED|95.0|0.59|1.5||||||||1.50|0.59|
72363370|NCT00135226|144237673|OTHER||Rate Ratio|0.96|||||TWO_SIDED|95.0|0.68|1.34||||||||1.34|0.68|
72363371|NCT00135226|144237673|OTHER||Rate Ratio|0.8|||||TWO_SIDED|95.0|0.57|1.12||||||||1.12|0.57|
72363372|NCT00135226|144237674|OTHER||Rate Ratio|0.98|||||TWO_SIDED|95.0|0.84|1.15||||||||1.15|0.84|
72363373|NCT00135226|144237674|OTHER||Rate ratio|0.95|||||TWO_SIDED|95.0|0.82|1.12||||||||1.12|0.82|
72363374|NCT00135226|144237675|OTHER||Rate ratio|1.19|||||TWO_SIDED|95.0|0.86|1.63||||||||1.63|0.86|
72363375|NCT00135226|144237675|OTHER||Rate Ratio|0.93|||||TWO_SIDED|95.0|0.68|1.28||||||||1.28|0.68|
72363376|NCT00135226|144237676|OTHER||Rate Ratio|0.8|||||TWO_SIDED|95.0|0.64|1.01||||||||1.01|0.64|
72363377|NCT00135226|144237676|OTHER||Rate Ratio|1.26|||||TWO_SIDED|95.0|1.0|1.59||||||||1.59|1.00|
72363378|NCT00135226|144237677|OTHER||Rate Ratio|0.86|||||TWO_SIDED|95.0|0.46|1.6||||||||1.60|0.46|
72363379|NCT00135226|144237677|OTHER||Rate ratio|0.77|||||TWO_SIDED|95.0|0.41|1.45||||||||1.45|0.41|
72363380|NCT00135226|144237678|OTHER||Rate Ratio|0.75|||||TWO_SIDED|95.0|0.17|3.3||||||||3.30|0.17|
72363381|NCT00135226|144237678|OTHER||Rate Ratio|0.75|||||TWO_SIDED|95.0|0.17|3.31||||||||3.31|0.17|
72363382|NCT00135226|144237679|OTHER||Rate Ratio|1.01|||||TWO_SIDED|95.0|0.92|1.11||||||||1.11|0.92|
72363383|NCT00135226|144237679|OTHER||Risk Ratio|1.0|||||TWO_SIDED|95.0|0.91|1.1||||||||1.10|0.91|
72363384|NCT00135226|144237680|OTHER||Rate Ratio|1.06|||||TWO_SIDED|95.0|0.78|1.43||||||||1.43|0.78|
72363385|NCT00135226|144237681|OTHER||Rate ratio|0.98|||||TWO_SIDED|95.0|0.74|1.29||||||||1.29|0.74|
72363386|NCT00135226|144237681|OTHER||Rate Ratio|1.04|||||TWO_SIDED|95.0|0.79|1.37||||||||1.37|0.79|
72363387|NCT00135226|144237682|OTHER||Rate Ratio|1.13|||||TWO_SIDED|95.0|0.97|1.32||||||||1.32|0.97|
72363388|NCT00135226|144237682|OTHER||Rate Ratio|1.07|||||TWO_SIDED|95.0|0.91|1.25||||||||1.25|0.91|
72363389|NCT00135226|144237683|OTHER||Rate Ratio|1.02|||||TWO_SIDED|95.0|0.76|1.38||||||||1.38|0.76|
72363390|NCT00135226|144237683|OTHER||Rate Ratio|1.17|||||TWO_SIDED|95.0|0.87|1.58||||||||1.58|0.87|
72363391|NCT00135226|144237684|OTHER||Rate Ratio|1.01|||||TWO_SIDED|95.0|0.76|1.34||||||||1.34|0.76|
72363392|NCT00135226|144237684|OTHER||Rate Ratio|1.14|||||TWO_SIDED|95.0|0.86|1.52||||||||1.52|0.86|
72363393|NCT00135226|144237685|OTHER||Rate Ratio|0.85|||||TWO_SIDED|95.0|0.58|1.23||||||||1.23|0.58|
72363394|NCT00135226|144237685|OTHER||Rate ratio|1.02|||||TWO_SIDED|95.0|0.7|1.48||||||||1.48|0.70|
72363395|NCT00135226|144237686|OTHER||Rate Ratio|0.83|||||TWO_SIDED|95.0|0.49|1.41||||||||1.41|0.49|
72363396|NCT00135226|144237686|OTHER||Rate Ratio|0.72|||||TWO_SIDED|95.0|0.42|1.22||||||||1.22|0.42|
72363397|NCT00135226|144237687|OTHER||Rate Ratio|0.84|||||TWO_SIDED|95.0|0.5|1.41||||||||1.41|0.50|
72363398|NCT00135226|144237687|OTHER||Rate Ratio|0.78|||||TWO_SIDED|95.0|0.46|1.31||||||||1.31|0.46|
72363399|NCT00135226|144237688|OTHER||Rate Ratio|1.23|||||TWO_SIDED|95.0|0.98|1.54||||||||1.54|0.98|
72363400|NCT00135226|144237689|OTHER||Rate Ratio|0.84|||||TWO_SIDED|95.0|0.63|1.12||||||||1.12|0.63|
72363401|NCT03279081|144237714|SUPERIORITY||Difference in Combined Remission Rate|2.37|||=|0.571|TWO_SIDED|95.0|-5.82|10.55||P-value was based on stratified Cochran-Mantel-Haenszel (CMH) test adjusting for interactive web response system (IWRS) randomization stratification factors.|Cochran-Mantel-Haenszel||The asymptotic Wald's confidence intervals (CI) are displayed.|||10.55|-5.82|=0.571
72363402|NCT03279081|144237715|SUPERIORITY||Difference in Clinical Remission Rate|2.72|||=|0.515|TWO_SIDED|95.0|-5.47|10.9||P-value was based on stratified CMH test adjusting for IWRS randomization stratification factors.|Cochran-Mantel-Haenszel||The asymptotic Wald's confidence intervals are displayed.|||10.90|-5.47|=0.515
72363403|NCT03279081|144237716|SUPERIORITY||Hazard Ratio (HR)|1.09|||=|0.374|TWO_SIDED|95.0|0.9|1.32||P-value was based on a stratified log-rank test adjusting for IWRS randomization stratification factors.|Log Rank||Cox Proportional Hazard Regression model was used to estimate the hazard ratio and 95% CI, adjusting for IWRS randomization stratification factors.|||1.32|0.90|=0.374
72363404|NCT03279081|144237717|SUPERIORITY||Difference in Combined Remission Rate|1.27|||=|0.757|TWO_SIDED|95.0|-6.77|9.31||P-value was based on stratified CMH test adjusting for IWRS randomization stratification factors.|Cochran-Mantel-Haenszel||The asymptotic Wald's confidence intervals are displayed.|||9.31|-6.77|=0.757
72363405|NCT03279081|144237718|SUPERIORITY||Difference in Clinical Remission Rate|1.6|||=|0.697|TWO_SIDED|95.0|-6.46|9.66||P-value was based on stratified CMH test adjusting for IWRS randomization stratification factors.|Cochran-Mantel-Haenszel||The asymptotic Wald's confidence intervals are displayed.|||9.66|-6.46|=0.697
72363406|NCT03279081|144237719|SUPERIORITY||Difference in Clinical Response Rate|3.23|||=|0.428|TWO_SIDED|95.0|-4.76|11.21||P-value was based on stratified CMH test adjusting for IWRS randomization stratification factors.|Cochran-Mantel-Haenszel||The asymptotic Wald's confidence intervals are displayed.|||11.21|-4.76|=0.428
72363407|NCT03279081|144237720|SUPERIORITY||Difference in Clinical Response Rate|2.84|||=|0.497|TWO_SIDED|95.0|-5.35|11.03||P-value was based on stratified CMH test adjusting for IWRS randomization stratification factors.|Cochran-Mantel-Haenszel||The asymptotic Wald's confidence intervals are displayed.|||11.03|-5.35|=0.497
72363408|NCT03279081|144237721|SUPERIORITY||Hazard Ratio (HR)|1.09|||=|0.363|TWO_SIDED|95.0|0.9|1.32||P-value was based on a stratified log-rank test adjusting for IWRS randomization stratification factors.|Log Rank||Cox Proportional Hazard Regression model was used to estimate hazard ratio and 95% CI, adjusting for IWRS randomization stratification factors.|||1.32|0.90|=0.363
72363409|NCT03279081|144237722|SUPERIORITY||Hazard Ratio (HR)|0.98|||=|0.833|TWO_SIDED|95.0|0.82|1.18||P-value was based on a stratified log-rank test adjusting for IWRS randomization stratification factors.|Log Rank||Cox Proportional Hazard Regression model was used to estimate hazard ratio and 95% CI, adjusting for IWRS randomization stratification factors.|||1.18|0.82|=0.833
72363410|NCT03279081|144237723|SUPERIORITY||Hazard Ratio (HR)|0.97|||=|0.717|TWO_SIDED|95.0|0.81|1.16||P-value was based on a stratified log-rank test adjusting for IWRS randomization stratification factors.|Log Rank||Cox Proportional Hazard Regression model was used to estimate hazard ratio and 95% CI, adjusting for IWRS randomization stratification factors.|||1.16|0.81|=0.717
72363411|NCT03279081|144237724|SUPERIORITY||Difference in Relapse Rate|3.03|||=|0.599|TWO_SIDED|95.0|-8.28|14.34||P-value was based on stratified CMH test adjusting for IWRS randomization stratification factors.|Cochran-Mantel-Haenszel||The asymptotic Wald's confidence intervals are displayed.|||14.34|-8.28|=0.599
72363412|NCT01345240|144237886|NON_INFERIORITY|Criteria for non-inferiority: one month post Dose 3, upper limit (UL) of the 2-sided 95% confidence interval (CI) on the difference in percent seroprotection below 5% between recipients of licensed hepatitis B vaccine (Engerix-B) and recipients of RTS,S/AS01E vaccine.|Difference in percent seroprotection|-3.95|||||TWO_SIDED|95.0|-7.12|-2.16||||||Non-inferiority of the immune response to the hepatitis B antigen induced by RTS,S/AS01E vaccine versus a licensed hepatitis B vaccine.||-2.16|-7.12|
72363413|NCT01345240|144237889|EQUIVALENCE|Criteria for consistency: one month post Dose 3 of RTS,S/AS01E, the two-sided 95% confidence interval (CI) of the geometric mean concentration (GMC) ratio between all pairs of lots are within \[0.5, 2\].|GMC ratio|0.91|||||TWO_SIDED|95.0|0.69|1.2|||ANOVA|||To demonstrate the lot-to-lot consistency in terms of anti-HBs immunogenicity between three commercial lots of the RTS,S/AS01E candidate malaria vaccine.||1.20|0.69|
72363414|NCT01345240|144237889|EQUIVALENCE|Criteria for consistency: one month post Dose 3 of RTS,S/AS01E, the two-sided 95% confidence interval (CI) of the geometric mean concentration (GMC) ratio between all pairs of lots are within \[0.5, 2\].|GMC ratio|1.0|||||TWO_SIDED|95.0|0.76|1.32|||ANOVA|||To demonstrate the lot-to-lot consistency in terms of anti-HBs immunogenicity between three commercial lots of the RTS,S/AS01E candidate malaria vaccine.||1.32|0.76|
72363415|NCT01345240|144237889|EQUIVALENCE|Criteria for consistency: one month post Dose 3 of RTS,S/AS01E, the two-sided 95% confidence interval (CI) of the geometric mean concentration (GMC) ratio between all pairs of lots are within \[0.5, 2\].|GMC ratio|1.1|||||TWO_SIDED|95.0|0.84|1.45|||ANOVA|||To demonstrate the lot-to-lot consistency in terms of anti-HBs immunogenicity between three commercial lots of the RTS,S/AS01E candidate malaria vaccine.||1.45|0.84|
72363416|NCT01345240|144237897|NON_INFERIORITY|Criteria for non-inferiority: one month post Dose 3, upper limit (UL) of the 2-sided 95% confidence interval (CI) on the GMC ratios of 10 pneumococcal serotypes titers (measured with an ELISA test), is below a limit of 2 for the pneumococcal conjugate vaccine when co-administered with versus without RTS,S/AS01E.|GMC ratio|1.15|||||TWO_SIDED|95.0|0.95|1.39|||ANOVA|||To demonstrate the non-inferiority of antibody against serotype 1 responses to the pneumococcal conjugate vaccine when co-administered with versus without RTS,S/AS01E as part of an EPI regimen.||1.39|0.95|
72363417|NCT01345240|144237897|NON_INFERIORITY|Criteria for non-inferiority: one month post Dose 3, upper limit (UL) of the 2-sided 95% confidence interval (CI) on the GMC ratios of 10 pneumococcal serotypes titers (measured with an ELISA test), is below a limit of 2 for the pneumococcal conjugate vaccine when co-administered with versus without RTS,S/AS01E.|GMC ratio|1.2|||||TWO_SIDED|95.0|0.97|1.48|||ANOVA|||To demonstrate the non-inferiority of antibody against serotype 4 responses to the pneumococcal conjugate vaccine when co-administered with versus without RTS,S/AS01E as part of an EPI regimen.||1.48|0.97|
72363418|NCT01345240|144237897|NON_INFERIORITY|Criteria for non-inferiority: one month post Dose 3, upper limit (UL) of the 2-sided 95% confidence interval (CI) on the GMC ratios of 10 pneumococcal serotypes titers (measured with an ELISA test), is below a limit of 2 for the pneumococcal conjugate vaccine when co-administered with versus without RTS,S/AS01E.|GMC ratio|1.27|||||TWO_SIDED|95.0|1.06|1.52|||ANOVA|||To demonstrate the non-inferiority of antibody against serotype 5 responses to the pneumococcal conjugate vaccine when co-administered with versus without RTS,S/AS01E as part of an EPI regimen.||1.52|1.06|
72363419|NCT01345240|144237897|NON_INFERIORITY|Criteria for non-inferiority: one month post Dose 3, upper limit (UL) of the 2-sided 95% confidence interval (CI) on the GMC ratios of 10 pneumococcal serotypes titers (measured with an ELISA test), is below a limit of 2 for the pneumococcal conjugate vaccine when co-administered with versus without RTS,S/AS01E.|GMC ratio|1.17|||||TWO_SIDED|95.0|0.83|1.65|||ANOVA|||To demonstrate the non-inferiority of antibody against serotype 6B responses to the pneumococcal conjugate vaccine when co-administered with versus without RTS,S/AS01E as part of an EPI regimen.||1.65|0.83|
72363420|NCT01345240|144237897|NON_INFERIORITY|Criteria for non-inferiority: one month post Dose 3, upper limit (UL) of the 2-sided 95% confidence interval (CI) on the GMC ratios of 10 pneumococcal serotypes titers (measured with an ELISA test), is below a limit of 2 for the pneumococcal conjugate vaccine when co-administered with versus without RTS,S/AS01E.|GMC ratio|1.12|||||TWO_SIDED|95.0|0.94|1.33|||ANOVA|||To demonstrate the non-inferiority of antibody against serotype 7F responses to the pneumococcal conjugate vaccine when co-administered with versus without RTS,S/AS01E as part of an EPI regimen.||1.33|0.94|
72363421|NCT01345240|144237897|NON_INFERIORITY|Criteria for non-inferiority: one month post Dose 3, upper limit (UL) of the 2-sided 95% confidence interval (CI) on the GMC ratios of 10 pneumococcal serotypes titers (measured with an ELISA test), is below a limit of 2 for the pneumococcal conjugate vaccine when co-administered with versus without RTS,S/AS01E.|GMC ratio|1.32|||||TWO_SIDED|95.0|1.08|1.63|||ANOVA|||To demonstrate the non-inferiority of antibody against serotype 9V responses to the pneumococcal conjugate vaccine when co-administered with versus without RTS,S/AS01E as part of an EPI regimen.||1.63|1.08|
72363422|NCT01345240|144237897|NON_INFERIORITY|Criteria for non-inferiority: one month post Dose 3, upper limit (UL) of the 2-sided 95% confidence interval (CI) on the GMC ratios of 10 pneumococcal serotypes titers (measured with an ELISA test), is below a limit of 2 for the pneumococcal conjugate vaccine when co-administered with versus without RTS,S/AS01E.|GMC ratio|0.99|||||TWO_SIDED|95.0|0.77|1.27|||ANOVA|||To demonstrate the non-inferiority of antibody against serotype 14 responses to the pneumococcal conjugate vaccine when co-administered with versus without RTS,S/AS01E as part of an EPI regimen.||1.27|0.77|
72363423|NCT01345240|144237897|NON_INFERIORITY|Criteria for non-inferiority: one month post Dose 3, upper limit (UL) of the 2-sided 95% confidence interval (CI) on the GMC ratios of 10 pneumococcal serotypes titers (measured with an ELISA test), is below a limit of 2 for the pneumococcal conjugate vaccine when co-administered with versus without RTS,S/AS01E.|GMC ratio|1.81|||||TWO_SIDED|95.0|1.38|2.38|||ANOVA|||To demonstrate the non-inferiority of antibody against 18C responses to the pneumococcal conjugate vaccine when co-administered with versus without RTS,S/AS01E as part of an EPI regimen.||2.38|1.38|
72363424|NCT01345240|144237897|NON_INFERIORITY|Criteria for non-inferiority: one month post Dose 3, upper limit (UL) of the 2-sided 95% confidence interval (CI) on the GMC ratios of 10 pneumococcal serotypes titers (measured with an ELISA test), is below a limit of 2 for the pneumococcal conjugate vaccine when co-administered with versus without RTS,S/AS01E.|GMC ratio|1.21|||||TWO_SIDED|95.0|0.89|1.65|||ANOVA|||To demonstrate the non-inferiority of antibody against serotype 19F responses to the pneumococcal conjugate vaccine when co-administered with versus without RTS,S/AS01E as part of an EPI regimen.||1.65|0.89|
72363425|NCT01345240|144237897|NON_INFERIORITY|Criteria for non-inferiority: one month post Dose 3, upper limit (UL) of the 2-sided 95% confidence interval (CI) on the GMC ratios of 10 pneumococcal serotypes titers (measured with an ELISA test), is below a limit of 2 for the pneumococcal conjugate vaccine when co-administered with versus without RTS,S/AS01E.|GMC ratio|1.12|||||TWO_SIDED|95.0|0.81|1.55|||ANOVA|||To demonstrate the non-inferiority of antibody against 23F responses to the pneumococcal conjugate vaccine when co-administered with versus without RTS,S/AS01E as part of an EPI regimen.||1.55|0.81|
72368571|NCT02304367|144247145|OTHER|||||||0.962|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline P1NP.||Week 192||||0.962
72429821|NCT01163149|144370805|SUPERIORITY||Hodges-Lehmann-Sen|1.33||||0.3827|TWO_SIDED|95.0|-1.36|3.12||Two-sided with p-value threshold \<0.05 for statistical significance|Wilcoxon rank-sum|||Lumbar Spine BMC Change from Baseline to Week 24||3.120|-1.360|0.3827
72363426|NCT01345240|144237903|NON_INFERIORITY|Criteria for non-inferiority: one month post Dose 3, upper limit (UL) of the 2-sided 95% confidence interval (CI) on the GMC ratios of anti-PT, anti-FHA, anti-PRN antibody concentrations, is below a limit of 2 for the DTPa/Hib vaccine when co-administered with versus without RTS,S/AS01E.|GMC ratio|1.08|||||TWO_SIDED|95.0|0.97|1.2|||ANOVA|||To demonstrate the non-inferiority of antibody response to the acellular B pertussis antigen, pertussis toxoid, (PT) of the DTPa/Hib vaccine when co-administered with RTS,S/AS01E as part of an EPI regimen.||1.20|0.97|
72363427|NCT01345240|144237903|NON_INFERIORITY|Criteria for non-inferiority: one month post Dose 3, upper limit (UL) of the 2-sided 95% confidence interval (CI) on the GMC ratios of anti-PT, anti-FHA, anti-PRN antibody concentrations, is below a limit of 2 for the DTPa/Hib vaccine when co-administered with versus without RTS,S/AS01E.|GMC ratio|1.08|||||TWO_SIDED|95.0|0.97|1.21|||ANOVA|||To demonstrate the non-inferiority of antibody response to the acellular B pertussis antigen, filamentous haemagglutinin (FHA), of the DTPa/Hib vaccine when co-administered with RTS,S/AS01E as part of an EPI regimen.||1.21|0.97|
72363428|NCT01345240|144237903|NON_INFERIORITY|Criteria for non-inferiority: one month post Dose 3, upper limit (UL) of the 2-sided 95% confidence interval (CI) on the GMC ratios of anti-PT, anti-FHA, anti-PRN antibody concentrations, is below a limit of 2 for the DTPa/Hib vaccine when co-administered with versus without RTS,S/AS01E.|GMC ratio|1.1|||||TWO_SIDED|95.0|0.98|1.22|||ANOVA|||To demonstrate the non-inferiority of antibody response to the acellular B pertussis antigen, pertactin (anti-PRN), of the DTPa/Hib vaccine when co-administered with RTS,S/AS01E as part of an EPI regimen.||1.22|0.98|
72363429|NCT01345240|144237904|NON_INFERIORITY|Criteria for non-inferiority: one month post Dose 2, upper limit (UL) of the 2-sided 95% confidence interval (CI) on the geometric mean concentrations (GMC) ratios of rotavirus antibodies (IgA) concentrations is below 2 for the rotavirus vaccine when co-administered with versus without RTS,S/AS01E.|GMC ratio|1.11|||||TWO_SIDED|95.0|0.76|1.61|||ANOVA|||To demonstrate the non-inferiority of antibody response to the rotavirus vaccine when co-administered with versus without RTS,S/AS01E as part of an EPI regimen||1.61|0.76|
72363430|NCT00449696|144237916|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.91||||0.122||95.0|||||Quadratic Spline Model||Tested superiority of Gel-200 using quadratic spline model for difference between Gel-200 and PBS placebo. Only difference between groups was presented by the pre-specified model as primary endpoint.|||||0.122
72363431|NCT00449696|144237917|SUPERIORITY_OR_OTHER||Mean Difference (Net)|5.42||||0.071||95.0|||||Quadratic Spline Model||Tested superiority of Gel-200 using quadratic spline model for difference between Gel-200 and PBS placebo. Only difference between groups was presented by the pre-specified model as primary endpoint.|||||0.071
72363432|NCT00449696|144237918|SUPERIORITY_OR_OTHER||Mean Difference (Net)|5.64||||0.058||95.0|||||Quadratic Spline Model||Tested superiority of Gel-200 using quadratic spline model for difference between Gel-200 and PBS placebo. Only difference between groups was presented by the pre-specified model as primary endpoint.|||||0.058
72363433|NCT00449696|144237919|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.59||||0.022||95.0||||P-value for strict OMERACT-OARSI response.|Generalized Estimating Equation Model|||||||0.022
72363434|NCT00449696|144237919|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.27||||0.242||95.0||||P-value for OMERACT-OARSI response.|Generalized Estimating Equation Model|||||||0.242
72363435|NCT00449696|144237920|SUPERIORITY_OR_OTHER||||||>|0.05||95.0||||P-value for physical component scores, physical function subscale, role physical subscale, and bodily pain subscale.|Wilcoxon (Mann-Whitney)|||||||>0.05
72363436|NCT00449696|144237921|SUPERIORITY_OR_OTHER||Mean Difference (Net)|6.39||||0.037||95.0|||||Quadratic Spline Model||Tested superiority of Gel-200 using quadratic spline model for difference between Gel-200 and PBS placebo. Only difference between groups was presented by the pre-specified model as primary endpoint.|||||0.037
72363437|NCT00449696|144237922|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.92||||0.746||95.0|||||Quadratic Spline Model||Tested superiority of Gel-200 using quadratic spline model for difference between Gel-200 and PBS placebo. Only difference between groups was presented by the pre-specified model as primary endpoint.|||||0.746
72363438|NCT00449696|144237923|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.56||||0.166||95.0|||||Quadratic Spline Model||Tested superiority of Gel-200 using quadratic spline model for difference between Gel-200 and PBS placebo. Only difference between groups was presented by the pre-specified model as primary endpoint.|||||0.166
72363439|NCT00449696|144237924|SUPERIORITY_OR_OTHER|||||||0.041||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.041
72363440|NCT01903460|144237977|SUPERIORITY_OR_OTHER||LS mean difference from placebo|-40.707||||0.574|TWO_SIDED|95.0|-191.679|110.265|||ANCOVA|||Analysis of LUM001 140ug/kg/day||110.265|-191.679|0.5740
72363441|NCT01903460|144237977|SUPERIORITY_OR_OTHER||LS mean difference from placebo|-7.231||||0.9147|TWO_SIDED|95.0|-148.726|134.264|||ANCOVA|||Analysis of LUM001 280ug/kg/day||134.264|-148.726|0.9147
72363442|NCT01903460|144237977|SUPERIORITY_OR_OTHER||LS mean difference from placebo|-23.969||||0.6954|TWO_SIDED|95.0|-151.969|104.031|||ANCOVA|||Analysis of all doses of LUM001||104.031|-151.969|0.6954
72363443|NCT01903460|144237978|SUPERIORITY_OR_OTHER||LS mean difference from placebo|56.7||||0.0783|TWO_SIDED|95.0|-7.2|120.6|||ANCOVA|||Analysis of LUM001 140ug/kg/day for ALT||120.6|-7.2|0.0783
72363444|NCT01903460|144237978|SUPERIORITY_OR_OTHER||LS mean difference from placebo|7.8||||0.7827|TWO_SIDED|95.0|-51.4|67.0|||ANCOVA|||Analysis of LUM001 280ug/kg/day for ALT||67.0|-51.4|0.7827
72429822|NCT01163149|144370805|SUPERIORITY||Hodges-Lehmann-Sen|-77.1||||0.0485|TWO_SIDED|95.0|-917.44|-1.74||Two-sided with p-value threshold \<0.05 for statistical significance|Wilcoxon rank-sum|||Whole Body BMC Change from Baseline to Week 24||-1.740|-917.440|0.0485
72363445|NCT01903460|144237978|SUPERIORITY_OR_OTHER||LS mean difference from placebo|32.2||||0.2235|TWO_SIDED|95.0|-21.9|86.3|||ANCOVA|||Analysis of all doses of LUM001 for ALT||86.3|-21.9|0.2235
72363446|NCT01903460|144237978|SUPERIORITY_OR_OTHER||LS mean difference from placebo|24.0||||0.2372|TWO_SIDED|95.0|-17.5|65.5|||ANCOVA|||Analysis of LUM001 140ug/kg/day for AST||65.5|-17.5|0.2372
72363447|NCT01903460|144237978|SUPERIORITY_OR_OTHER||LS mean difference from placebo|-15.8||||0.3914|TWO_SIDED|95.0|-54.1|22.4|||ANCOVA|||Analysis of LUM001 280ug/kg/day for AST||22.4|-54.1|0.3914
72363448|NCT01903460|144237978|SUPERIORITY_OR_OTHER||LS mean difference from placebo|4.1||||0.8081|TWO_SIDED|95.0|-31.0|39.1|||ANCOVA|||Analysis of all doses of LUM001 for AST||39.1|-31.0|0.8081
72363449|NCT01903460|144237978|SUPERIORITY_OR_OTHER||LS mean difference from placebo|51.7||||0.5748|TWO_SIDED|95.0|-140.3|243.7|||ANCOVA|||Analysis of LUM001 140ug/kg/day for ALP||243.7|-140.3|0.5748
72429823|NCT01163149|144370806|SUPERIORITY||Hodges-Lehmann-Sen|-0.0125||||0.7357|TWO_SIDED|95.0|-0.04|0.039||Two-sided with p-value threshold \<0.05 for statistical significance|Wilcoxon rank-sum|||Hip Total Change from Baseline to Week 24||0.0390|-0.0400|0.7357
72429824|NCT01163149|144370806|SUPERIORITY||Hodges-Lehmann-Sen|0.0255||||0.2439|TWO_SIDED|95.0|-0.009|0.041||Two-sided with p-value threshold \<0.05 for statistical significance|Wilcoxon rank-sum|||Lumbar Spine BMD Change from Baseline to Week 24||0.0410|-0.0090|0.2439
72429825|NCT01163149|144370806|SUPERIORITY||Hodges-Lehmann-Sen|-0.0315||||0.1222|TWO_SIDED|95.0|-0.059|0.012||Two-sided with p-value threshold \<0.05 for statistical significance|Wilcoxon rank-sum|||Whole Body BMD Change from Baseline to Week 24||0.0120|-0.0590|0.1222
72429826|NCT01163149|144370807|SUPERIORITY||Hodges-Lehmann-Sen|44.0||||0.1303|TWO_SIDED|95.0|-73.0|114.0||Two-sided with p-value threshold \<0.05 for statistical significance|Wilcoxon rank-sum||Estimate and exact confidence interval are from Hodges-Lehmann-Sen method for location shift in distribution between the treatment group and the control group|Week 24 Change from Baseline||114.0|-73.0|0.1303
72429827|NCT02806336|144370811|SUPERIORITY|||||||0.03|||||||t-test, 2 sided|||change in combined groups||||0.03
72429828|NCT02806336|144370812|SUPERIORITY|||||||0.34|||||||t-test, 2 sided|||||||0.34
72429829|NCT02806336|144370813|SUPERIORITY|||||||0.78|||||||t-test, 2 sided|||||||0.78
72429830|NCT02806336|144370814|SUPERIORITY|||||||0.03||||||change in functional gait analysis (FGA) in combined groups compared to baseline|t-test, 2 sided|||||||0.03
72429831|NCT02806336|144370815|SUPERIORITY|||||||0.14|||||||t-test, 2 sided|||||||0.14
72429832|NCT02806336|144370816|SUPERIORITY|||||||0.17|||||||t-test, 2 sided|||||||.17
72429833|NCT02806336|144370816|SUPERIORITY|||||||0.14|||||||t-test, 2 sided|||||||0.14
72429834|NCT02806336|144370817|SUPERIORITY|||||||0.23|||||||t-test, 2 sided|||||||0.23
72429835|NCT01923428|144370857|SUPERIORITY||Risk Difference (RD)|27.0|||<|0.001|TWO_SIDED|95.0|||||Cochran-Mantel-Haenszel|||||||<0.001
72429836|NCT02550873|144370864|SUPERIORITY||Mean Difference (Net)|2.3|STANDARD_ERROR_OF_MEAN|0.72||0.0014|TWO_SIDED|90.0|1.1|3.5||a priori threshold for statistical significance = 0.10|Mixed Models Analysis|Random intercept; dependent variable=raw values at each time point; explanatory variables=stratum, treatment, time and treatment by time interaction||"The sample size calculation was based on the following assumptions:~Normal distribution Homogeneity of variance the same in both arms, and for both types of patients Randomization ratio PRM-151:placebo = 2:1 Expected value for patients on pirfenidone or nintedanib = -1.5 Expected value for patients on no other treatment = -3 Expected value for patients on PRM-151 ≥ 0.75 Standard deviation = 5 75% of patients on a stable dose of pirfenidone or nintedanib α=0.10 two-sided Power = 80%"||3.5|1.1|0.0014
72429837|NCT02550873|144370865|SUPERIORITY||Mean Difference (Net)|31.3|STANDARD_ERROR_OF_MEAN|8.42||0.0002|TWO_SIDED|90.0|17.4|45.1||This study was not powered to test hypothesis beyond the primary endpoint.|Mixed Models Analysis|Random intercept; dependent variable=raw values at each time point; explanatory variables=stratum, treatment, time and treatment by time interaction.||||45.1|17.4|0.0002
72429838|NCT02550873|144370866|SUPERIORITY||Mean Difference (Net)|93.5|STANDARD_ERROR_OF_MEAN|72.98||0.2032|TWO_SIDED|90.0|-27.7|214.7||This study was not powered to test hypothesis beyond the primary endpoint.|Mixed Models Analysis|Random intercept and slope; dependent variable=raw values; explanatory variables=stratum, treatment, time and treatment by time interaction.||||214.7|-27.7|0.2032
72429839|NCT02550873|144370867|SUPERIORITY||Mean Difference (Net)|31.9|STANDARD_ERROR_OF_MEAN|46.33||0.4927|TWO_SIDED|90.0|-45.0|108.8||This study was not powered to test hypotheses beyond the primary endpoint.|Mixed Models Analysis|Random intercept; dependent variable=raw values at each time point; explanatory variables=stratum, treatment, time and treatment by time interaction||||108.8|-45.0|0.4927
72429840|NCT02550873|144370868|SUPERIORITY||Mean Difference (Net)|1.1|STANDARD_ERROR_OF_MEAN|1.96||0.5835|TWO_SIDED|90.0|-2.2|4.3||This study was not powered to test hypotheses beyond the primary endpoint.|Mixed Models Analysis|Random intercept; dependent variable=raw values at each time point; explanatory variables=stratum, treatment, time and treatment by time interaction||||4.3|-2.2|0.5835
72429841|NCT02550873|144370869|SUPERIORITY||Mean Difference (Net)|43.6|STANDARD_ERROR_OF_MEAN|102.28||0.6707|TWO_SIDED|90.0|-126.3|213.5||This study was not powered to test hypotheses beyond the primary endpoint.|Mixed Models Analysis|Random intercept; dependent variable=raw values at each time point; explanatory variables=stratum, treatment, time and treatment by time interaction||||213.5|-126.3|0.6707
72429842|NCT02550873|144370870|SUPERIORITY||Mean Difference (Net)|-1.2|STANDARD_ERROR_OF_MEAN|1.91||0.52|TWO_SIDED|90.0|-4.4|1.9||This study was not powered to test hypotheses beyond the primary endpoint.|Mixed Models Analysis|Random intercept; dependent variable=raw values at each time point; explanatory variables=stratum, treatment, time and treatment by time interaction||||1.9|-4.4|0.52
72429843|NCT02550873|144370871|OTHER|Correlation analysis||||||0.0001||||||This study was not powered to test hypotheses beyond the primary endpoint.|Pearson's correlation|||||||0.0001
72429844|NCT02550873|144370871|OTHER|Correlation analysis||||||0.0069|||||||Pearson's correlation|||This study was not powered to test hypotheses beyond the primary endpoint.||||0.0069
72429845|NCT02550873|144370872|SUPERIORITY|||||||0.4179||||||P-Value for decline in % Predicted FVC ≥ 5%. This study was not powered to test hypotheses beyond the primary endpoint.|Mixed Models Analysis|Random intercept; dependent variable=raw values at each time point; explanatory variables=stratum, treatment, time and treatment by time interaction||||||0.4179
72429846|NCT02550873|144370872|SUPERIORITY|||||||0.2184||||||P-Value for decline in % predicted FVC ≥ 10%. This study was not powered to test hypotheses beyond the primary endpoint.|Mixed Models Analysis|Random intercept; dependent variable=raw values at each time point; explanatory variables=stratum, treatment, time and treatment by time interaction||||||0.2184
72429847|NCT02550873|144370873|SUPERIORITY|||||||0.7773||||||P-Value for decline in FVC ≥ 100 mL. This study was not powered to test hypotheses beyond the primary endpoint.|Mixed Models Analysis|Random intercept; dependent variable=raw values at each time point; explanatory variables=stratum, treatment, time and treatment by time interaction||||||0.7773
72429848|NCT02550873|144370873|SUPERIORITY|||||||0.5976||||||P-Value for decline in FVC ≥ 200 mL. This study was not powered to test hypotheses beyond the primary endpoint.|Mixed Models Analysis|Random intercept; dependent variable=raw values at each time point; explanatory variables=stratum, treatment, time and treatment by time interaction||||||0.5976
72429849|NCT02550873|144370874|SUPERIORITY|||||||0.29||||||P-Value for increase in % predicted FVC ≥ 5%. P-Value for an increase in % predicted FVC ≥ 10% not reported. This study was not powered to test hypotheses beyond the primary endpoint.|Mixed Models Analysis|Random intercept; dependent variable=raw values at each time point; explanatory variables=stratum, treatment, time and treatment by time interaction||||||0.29
72429850|NCT02550873|144370875|SUPERIORITY|||||||0.0508||||||P-Value for increase in FVC ≥ 100 mL. P-Value for increase in FVC ≥ 200 mL not reported. This study was not powered to test hypotheses beyond the primary endpoint.|Mixed Models Analysis|Random intercept; dependent variable=raw values at each time point; explanatory variables=stratum, treatment, time and treatment by time interaction||||||0.0508
72429851|NCT02550873|144370876|SUPERIORITY|||||||0.6308||||||This study was not powered to test hypotheses beyond the primary endpoint.|Mixed Models Analysis|Random intercept; dependent variable=raw values at each time point; explanatory variables=stratum, treatment, time and treatment by time interaction||||||0.6308
72429852|NCT02550873|144370877|SUPERIORITY|||||||0.1846||||||This study was not powered to test hypothesis beyond the primary endpoint.|Mixed Models Analysis|Random intercept; dependent variable=raw values at each time point; explanatory variables=stratum, treatment, time and treatment by time interaction||||||0.1846
72429853|NCT02550873|144370878|SUPERIORITY||Mean Difference (Net)|-0.4|STANDARD_ERROR_OF_MEAN|1.31||0.7424|TWO_SIDED|90.0|-2.6|1.7||This study was not powered to test hypothesis beyond the primary endpoint.|Mixed Models Analysis|Random intercept; dependent variable=raw values at each time point; explanatory variables=stratum, treatment, time and treatment by time interaction.||||1.7|-2.6|0.7424
72429854|NCT02550873|144370888|SUPERIORITY||Mean Difference (Net)|114.6|STANDARD_DEVIATION|56.1||0.0416|TWO_SIDED|90.0|22.2|207.1||This study was not powered to test hypothesis beyond the primary endpoint.|Mixed Models Analysis|Random intercept and slope; dependent variable=raw values; explanatory variables=stratum, treatment, time and treatment by time interaction.||||207.1|22.2|0.0416
72429855|NCT01607411|144370889|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|5.59|||<|0.0001|TWO_SIDED|95.0|3.6|7.58||No adjustment was required for multiple comparisons as the primary comparison was pre-specified.|ANOVA|The fixed factors for ANOVA were study period and treatment and the subject was random effect|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment|Null hypothesis was no difference between treatments, being compared. Tests were 2 sided at 5% significance levels.||7.58|3.60|<0.0001
72429856|NCT01607411|144370889|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|4.36|||<|0.0001|TWO_SIDED|95.0|2.37|6.35||No adjustment was required for multiple comparisons as the primary comparison was pre-specified|ANOVA|The fixed factors for ANOVA were study period and treatment and the subject was random effect|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment|Null hypothesis was no difference between treatments, being compared. Tests were 2 sided at 5% significance levels||6.35|2.37|<0.0001
72429857|NCT01607411|144370889|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|3.16||||0.0021|TWO_SIDED|95.0|1.17|5.15||No adjustment was required for multiple comparisons as the primary comparison was pre-specified|ANOVA|The fixed factors for ANOVA were study period and treatment and the subject was random effect|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment|Null hypothesis was no difference between treatments, being compared. Tests were 2 sided at 5% significance levels||5.15|1.17|0.0021
72429858|NCT01607411|144370890|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|1.23||||0.2225|TWO_SIDED|95.0|-0.76|3.22||No adjustment was required for multiple comparisons as the primary comparison was pre-specified|ANOVA|The fixed factors for ANOVA were study period and treatment and the subject was random effect|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment|Null hypothesis was no difference between treatments, being compared. Tests were 2 sided at 5% significance levels||3.22|-0.76|0.2225
72429859|NCT01607411|144370890|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|2.44||||0.0168|TWO_SIDED|95.0|0.44|4.43||No adjustment was required for multiple comparisons as the primary comparison was pre-specified|ANOVA|The fixed factors for ANOVA were study period and treatment and the subject was random effect|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment|Null hypothesis was no difference between treatments, being compared. Tests were 2 sided at 5% significance levels.||4.43|0.44|0.0168
72429860|NCT01607411|144370890|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|1.2||||0.2352|TWO_SIDED|95.0|-0.79|3.19||No adjustment was required for multiple comparisons as the primary comparison was pre-specified|ANOVA|The fixed factors for ANOVA were study period and treatment and the subject was random effect|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment|Null hypothesis was no difference between treatments, being compared. Tests were 2 sided at 5% significance levels||3.19|-0.79|0.2352
72429861|NCT01607411|144370891|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|34.65|||<|0.0001|TWO_SIDED|95.0|30.07|39.24||No adjustment was required for multiple comparisons as the primary comparison was pre-specified|ANOVA|The fixed factors for ANOVA were study period and treatment and the subject was random effect|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment|Null hypothesis was no difference between treatments, being compared. Tests were 2 sided at 5% significance levels||39.24|30.07|<0.0001
72429862|NCT01607411|144370891|SUPERIORITY_OR_OTHER||Adjusted Mean difference|34.86|||<|0.0001|TWO_SIDED|95.0|30.28|39.44||No adjustment was required for multiple comparisons as the primary comparison was pre-specified|ANOVA|The fixed factors for ANOVA were study period and treatment and the subject was random effect|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment|Null hypothesis was no difference between treatments, being compared. Tests were 2 sided at 5% significance levels||39.44|30.28|<0.0001
72429863|NCT01607411|144370891|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|28.55|||<|0.0001|TWO_SIDED|95.0|23.97|33.13||No adjustment was required for multiple comparisons as the primary comparison was pre-specified|ANOVA|The fixed factors for ANOVA were study period and treatment and the subject was random effect|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment|Null hypothesis was no difference between treatments, being compared. Tests were 2 sided at 5% significance levels||33.13|23.97|< 0.0001
72429864|NCT01607411|144370891|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.21||||0.9292|TWO_SIDED|95.0|-4.79|4.38||No adjustment was required for multiple comparisons as the primary comparison was pre-specified|ANOVA|The fixed factors for ANOVA were study period and treatment and the subject was random effect|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment|Null hypothesis was no difference between treatments, being compared. Tests were 2 sided at 5% significance levels||4.38|-4.79|0.9292
72429865|NCT01607411|144370891|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|6.1||||0.0094|TWO_SIDED|95.0|1.52|10.69||No adjustment was required for multiple comparisons as the primary comparison was pre-specified|ANOVA|The fixed factors for ANOVA were study period and treatment and the subject was random effect|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment|Null hypothesis was no difference between treatments, being compared. Tests were 2 sided at 5% significance levels||10.69|1.52|0.0094
72429866|NCT01607411|144370891|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|6.31||||0.0073|TWO_SIDED|95.0|1.72|10.89||No adjustment was required for multiple comparisons as the primary comparison was pre-specified|ANOVA|The fixed factors for ANOVA were study period and treatment and the subject was random effect|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment|Null hypothesis was no difference between treatments, being compared. Tests were 2 sided at 5% significance levels||10.89|1.72|0.0073
72429867|NCT01607411|144370892|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.78|||<|0.0001|TWO_SIDED|95.0|0.58|0.98||No adjustment was required for multiple comparisons as the primary comparison was pre-specified|ANOVA|The fixed factors for ANOVA were study period and treatment and the subject was random factor|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment|Null hypothesis was no difference between treatments, being compared. Tests were 2 sided at 5% significance levels||0.98|0.58|<0.0001
72429868|NCT01607411|144370892|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.79|||<|0.0001|TWO_SIDED|95.0|0.58|0.99||No adjustment was required for multiple comparisons as the primary comparison was pre-specified|ANOVA|The fixed factors for ANOVA were study period and treatment and the subject was random effect|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment|Null hypothesis was no difference between treatments, being compared. Tests were 2 sided at 5% significance levels||0.99|0.58|<0.0001
72429869|NCT01607411|144370892|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.49|||<|0.0001|TWO_SIDED|95.0|0.29|0.69||No adjustment was required for multiple comparisons as the primary comparison was pre-specified|ANOVA|The fixed factors for ANOVA were study period and treatment and the subject was random effect|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment|Null hypothesis was no difference between treatments, being compared. Tests were 2 sided at 5% significance levels||0.69|0.29|< 0.0001
72429870|NCT01607411|144370892|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.005||||0.9631|TWO_SIDED|95.0|-0.21|0.2||No adjustment was required for multiple comparisons as the primary comparison was pre-specified|ANOVA|The fixed factors for ANOVA were study period and treatment and the subject was random effect|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment|Null hypothesis was no difference between treatments, being compared. Tests were 2 sided at 5% significance levels||0.20|-0.21|0.9631
72429871|NCT01607411|144370892|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.29||||0.0047|TWO_SIDED|95.0|0.09|0.49||No adjustment was required for multiple comparisons as the primary comparison was pre-specified|ANOVA|The fixed factors for ANOVA were study period and treatment and the subject was random effect|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment|Null hypothesis was no difference between treatments, being compared. Tests were 2 sided at 5% significance levels||0.49|0.09|0.0047
72429872|NCT01607411|144370892|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.3||||0.004|TWO_SIDED|95.0|0.1|0.5||No adjustment was required for multiple comparisons as the primary comparison was pre-specified|ANOVA|The fixed factors for ANOVA were study period and treatment and the subject was random effect|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment|Null hypothesis was no difference between treatments, being compared. Tests were 2 sided at 5% significance levels||0.50|0.10|0.0040
72429873|NCT03990363|144370900|SUPERIORITY|||||||0.0648|||||||Repeated Measures Mixed Model|||||||0.0648
72429874|NCT03990363|144370900|SUPERIORITY|||||||0.6296|||||||Repeated Measures Mixed Model|||||||0.6296
72429875|NCT03990363|144370900|SUPERIORITY|||||||0.0263|||||||Repeated Measures Mixed Model|||||||0.0263
72429876|NCT00556374|144370923|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.504|||<|0.0001|TWO_SIDED|95.0|0.39|0.65|||Cox Proportional Hazards Model|Stratification factors are hospital type, prior use of aromatase inhibitor, and baseline lumbar spine BMD.|From the Cox proportional hazard model with treatment as the independent variable and stratified by randomization strata. A hazard ratio \< 1.0 indicates a lower average event rate and a longer fracture-free time for denosumab relative to placebo.|The efficacy clinical hypothesis is that denosumab, when administered subcutaneously at a dose of 60 mg every 6 months, will be considered efficacious in patients with non-metastatic breast cancer receiving AIT if the rate of first clinical fracture in denosumab-treated patients is lower than that in placebo-treated patients. It is anticipated that denosumab will reduce the rate by 30% compared with placebo (ie, the true hazard ratio of denosumab compared with placebo is 0.70).||0.65|0.39|<0.0001
72429877|NCT00556374|144370924|SUPERIORITY_OR_OTHER_LEGACY||Difference from Placebo|10.02|||<|0.0001|TWO_SIDED|95.0|9.04|11.01||The Hochberg procedure was used to control for multiplicity.|ANCOVA|Model includes treatment group as the independent variable and adjusted for baseline value and the randomization stratification factors.||||11.01|9.04|<0.0001
72363450|NCT01903460|144237978|SUPERIORITY_OR_OTHER||LS mean difference from placebo|11.9||||0.8835|TWO_SIDED|95.0|-158.4|182.2|||ANCOVA|||Analysis of LUM001 280ug/kg/day for ALP||182.2|-158.4|0.8835
72363451|NCT01903460|144237978|SUPERIORITY_OR_OTHER||LS mean difference from placebo|31.8||||0.6917|TWO_SIDED|95.0|-135.8|199.4|||ANCOVA|||Analysis of all doses of LUM001 for ALP||199.4|-135.8|0.6917
72363452|NCT01903460|144237979|SUPERIORITY_OR_OTHER||LS mean difference from placebo|-0.348||||0.6907|TWO_SIDED|95.0|-2.468|1.772|||ANCOVA|||Analysis of LUM001 140ug/kg/day for Patient ItchRO||1.772|-2.468|0.6907
72363453|NCT01903460|144237979|SUPERIORITY_OR_OTHER||LS mean difference from placebo|0.202||||0.7897|TWO_SIDED|95.0|-1.647|2.052|||ANCOVA|||Analysis of LUM001 280ug/kg/day for Patient ItchRO||2.052|-1.647|0.7897
72363454|NCT01903460|144237979|SUPERIORITY_OR_OTHER||LS mean difference from placebo|-0.073||||0.9203|TWO_SIDED|95.0|-1.85|1.705|||ANCOVA|||Analysis of all doses of LUM001 for Patient ItchRO||1.705|-1.850|0.9203
72363455|NCT01903460|144237979|SUPERIORITY_OR_OTHER||LS mean difference from placebo|-0.21||||0.5966|TWO_SIDED|95.0|-1.038|0.618|||ANCOVA|||Analysis of LUM001 140ug/kg/day for Observer ItchRO||0.618|-1.038|0.5966
72363456|NCT01903460|144237979|SUPERIORITY_OR_OTHER||LS mean difference from placebo|0.173||||0.632|TWO_SIDED|95.0|-0.58|0.926|||ANCOVA|||Analysis of LUM001 280ug/kg/day for Observer ItchRO||0.926|-0.580|0.6320
72363457|NCT01903460|144237979|SUPERIORITY_OR_OTHER||LS mean difference from placebo|-0.019||||0.9547|TWO_SIDED|95.0|-0.71|0.673|||ANCOVA|||Analysis of all doses of LUM001 for Observer ItchRO||0.673|-0.710|0.9547
72363458|NCT05810740|144237993|OTHER||LS-Mean Ratio, Percent|96.43|||||TWO_SIDED|90.0|92.57|100.46||||||||100.46|92.57|
72363459|NCT05810740|144237994|OTHER||Geometric Mean Ratio|97.19|||||TWO_SIDED|90.0|93.47|101.06||||||||101.06|93.47|
72363460|NCT05810740|144237995|OTHER||Geometric Mean Ratio|94.02|||||TWO_SIDED|90.0|87.25|101.33||||||||101.33|87.25|
72363461|NCT05712460|144238049|OTHER||Ratio|126.65|||||TWO_SIDED|90.0|106.87|150.1|||||Analysis was performed using mixed effect model with sequence, and treatment as fixed effects and participant within sequence as a random effect.|||150.10|106.87|
72363462|NCT05712460|144238050|OTHER||Ratio|142.94|||||TWO_SIDED|90.0|117.2|174.32|||||Analysis was performed using mixed effect model with sequence, and treatment as fixed effects and participant within sequence as a random effect.|||174.32|117.20|
72363463|NCT02735863|144238059|SUPERIORITY|||||||0.5352|||||||Log Rank|||||||0.5352
72363464|NCT00829426|144238060|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% Confidence Interval falls withi 80-125.|Geometric Test/Ref Ratio x 100|102.56|||||TWO_SIDED|90.0|98.74|106.52|||||Bioequivalence is established when 90% Confidence Interval falls withi 80-125.|||106.52|98.74|
72363465|NCT00829426|144238061|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|An analysis of variance (ANOVA) was performed on each of the pharmacokinetic parameters using SAS® software.|Geometric Test/Ref Ratio x 100|92.88||||||90.0|90.34|95.48|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||95.48|90.34|
72363466|NCT00829426|144238062|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|An analysis of variance (ANOVA) was performed on each of the pharmacokinetic parameters using SAS® software.|Geometric Test/Ref Ratio x 100|93.92||||||90.0|91.47|96.44|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||96.44|91.47|
72363467|NCT05560425|144238064|EQUIVALENCE|"The equivalence margin is a range of the compliance score for which the independent training of skills in each group is close enough to be considered equivalent."|Mean Difference (Final Values)|1.29|STANDARD_ERROR_OF_MEAN|3.45|<|0.05|TWO_SIDED|95.0|-6.22|8.79|||t-test, 1 sided|degrees of freedom = 12||Null hypothesis: Compliance with independent training of skills is not equivalent between groups.||8.79|-6.22|<0.05
72363468|NCT02260934|144238072|SUPERIORITY|||||||0.58||||||Two-sided test|Regression, Logistic|Treatment group was the independent variable in the logistic regression.||Week 0 to Week 24||||0.58
72363469|NCT02260934|144238072|SUPERIORITY|||||||0.25||||||Two-sided test.|Regression, Logistic|Treatment group was the independent variable in the logistic regression.||Week 0 to Week 48||||0.25
72363470|NCT02260934|144238072|SUPERIORITY|||||||0.15||||||Two-sided test.|Regression, Logistic|Treatment group was the independent variable in the logistic regression.||Week 0 to Week 96.||||0.15
72363471|NCT02260934|144238074|SUPERIORITY|P-value could not be produced because of zero count in at least one of the treatment arms.|||||||||||||Regression, Logistic|Two sided test. P-value could not be produced because of zero count in at least one of the treatment arms.||Week 0 to Week 24|Treatment group was the independent variable in the logistic regression.|||
72363472|NCT02260934|144238074|SUPERIORITY||||||||||||||Regression, Logistic|P-value could not be produced because of zero count in at least one of the treatment arms.||Week 0 to Week 48|P-value could not be produced because of zero count in at least one of the treatment arms.|||
72363473|NCT02260934|144238074|SUPERIORITY|P-value could not be produced because of zero count in at least one of the treatment arms|||||||||||||Regression, Logistic|P-value could not be produced because of zero count in at least one of the treatment arms||Week 0 to Week 96 The modified intent to treat population includes all randomized participants who received 1 dose of Solumedrol, 1 dose of rituximab, 1 dose of cyclophosphamide, and, if in the Rituximab/Cyclophosphamide/Belimumab (RCB) arm, 1 dose of belimumab.|P-value could not be produced because of zero count in at least one of the treatment arms|||
72363474|NCT02260934|144238075|SUPERIORITY|Treatment group was the independent variable in the logistic regression.||||||0.66||||||Treatment group was the independent variable in the logistic regression.|Regression, Logistic|2 sided test||Week 24||||0.66
72363475|NCT02260934|144238075|SUPERIORITY|Treatment group was the independent variable in the logistic regression.||||||0.65||||||Treatment group was the independent variable in the logistic regression.|Regression, Logistic|2 sided test||Week 48|Treatment group was the independent variable in the logistic regression.|||0.65
72363476|NCT02260934|144238076|SUPERIORITY|Treatment group was the independent variable in the logistic regression.||||||0.64||||||2 sided test|Regression, Logistic|Treatment group was the independent variable in the logistic regression.||Week 24 Treatment group was the independent variable in the logistic regression.||||0.64
72363477|NCT02260934|144238076|SUPERIORITY|Treatment group was the independent variable in the logistic regression.||||||0.37||||||2 sided test|Regression, Logistic|Treatment group was the independent variable in the logistic regression.||Week 48||||0.37
72363478|NCT02260934|144238076|SUPERIORITY|Treatment group was the independent variable in the logistic regression.||||||0.32|||||||Regression, Logistic|Treatment group was the independent variable in the logistic regression.||Week 96||||0.32
72363479|NCT02260934|144238077|SUPERIORITY|Treatment group was the independent variable in the logistic regression.||||||0.91||||||2 sided test|Regression, Logistic|2 sided test||Week 96||||0.91
72363480|NCT02260934|144238078|SUPERIORITY|Treatment group was the independent variable in the logistic regression.||||||0.73||||||2 sided test|Regression, Logistic|2 sided test||Week 0 to Week 24||||.73
72363481|NCT02260934|144238078|SUPERIORITY|Treatment group was the independent variable in the logistic regression.||||||0.26||||||2 sided test|Regression, Logistic|2 sided test||Week 0 to Week 48||||0.26
72363482|NCT02260934|144238078|SUPERIORITY|Treatment group was the independent variable in the logistic regression.||||||0.29||||||2 sided test|Regression, Logistic|2 sided test||Week 0 to Week 96||||0.29
72363483|NCT02260934|144238079|SUPERIORITY|2 sided test|||||>|0.99||||||2 sided test|Fisher Exact|2 sided test||Week 0 to Week 24||||>0.99
72363484|NCT02260934|144238080|SUPERIORITY|2 sided test||||||0.49||||||2 sided test|Fisher Exact|2 sided test||Week 0 to Week 48||||0.49
72363485|NCT02260934|144238082|SUPERIORITY|2 sided test||||||0.89||||||2 sided test|Regression, Logistic|||Treatment group was the independent variable in the logistic regression.||||0.89
72363486|NCT02260934|144238082|SUPERIORITY|Week 48||||||0.47||||||2 sided test|Regression, Logistic|2 sided test||Treatment group was the independent variable in the logistic regression.||||0.47
72363487|NCT02260934|144238082|SUPERIORITY|Week 96||||||0.94||||||2 sided test|Regression, Logistic|2 sided test||Treatment group was the independent variable in the logistic regression.||||0.94
72363488|NCT02260934|144238083|SUPERIORITY|Week 24||||||0.08||||||2 sided test|Regression, Logistic|2 sided test||Treatment group was the independent variable in the logistic regression.||||0.08
72363489|NCT02260934|144238083|SUPERIORITY|Week 48||||||0.11||||||2 sided test|Regression, Logistic|2 sided test||Treatment group was the independent variable in the logistic regression.||||0.11
72363490|NCT02260934|144238083|SUPERIORITY|Week 96||||||0.05||||||2 sided test|Regression, Logistic|2 sided test||Treatment group was the independent variable in the logistic regression.||||0.05
72363491|NCT02260934|144238084|SUPERIORITY|Week 24||||||0.2||||||2 sided test|Regression, Logistic|2 sided test||Treatment group was the independent variable in the logistic regression.||||.20
72363492|NCT02260934|144238084|SUPERIORITY|Week 48|||||>|0.99||||||2 sided test|Regression, Logistic|2 sided test||Treatment group was the independent variable in the logistic regression.||||>0.99
72363493|NCT02260934|144238084|SUPERIORITY|Week 96||||||0.63||||||2 sided test|Regression, Logistic|2 sided test||Treatment group was the independent variable in the logistic regression.||||0.63
72363494|NCT00107653|144238094|SUPERIORITY_OR_OTHER||SVR for Study Group Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.041|<|0.0001|TWO_SIDED|95.0|-0.24|-0.08||P-values are calculated based on the difference in proportion between Latino and Non-Latino White group|Normal approximation to the binomial.||The estimated value is the difference in proportion of participants (Latino minus Non-Latino White) with SVR. The 95% Confidence Interval is based on normal approximation to the binomial.|SVR for Latino Versus (VS) Non-Latino White||-0.08|-0.24|<0.0001
72363495|NCT00107653|144238095|SUPERIORITY_OR_OTHER||Study Group Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.031||0.0454|TWO_SIDED|95.0|-0.12|0.0|||Normal approximation to the binomial.||The estimated value is the difference in proportion of participants (Latino minus Non-Latino White) with virologic response. The 95% Confidence Interval is based on normal approximation to the binomial.|Virologic Response for Latino VS Non-Latino White at Week 4||-0.00|-0.12|0.0454
72363496|NCT00107653|144238095|SUPERIORITY_OR_OTHER||Study Group Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.041||0.0003|TWO_SIDED|95.0|-0.23|-0.07|||Normal approximation to the binomial.||The estimated value is the Difference in proportion of participants (Latino minus Non-Latino White) with virologic response. the 95% Confidence Interval is based on normal approximation to the binomial.|Virologic Response for Latino VS Non-Latino White at Week 12||-0.07|-0.23|0.0003
72363497|NCT00107653|144238095|SUPERIORITY_OR_OTHER||Study Group Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.039||0.0004|TWO_SIDED|95.0|-0.22|-0.06|||Normal approximation to the binomial.||The estimated value is the difference in proportion of participants (Latino minus Non-Latino White) with virologic response. The 95% Confidence Interval is based on normal approximation to the binomial.|Virologic Response for Latino VS Non-Latino White at Week 24||-0.06|-0.22|0.0004
72363498|NCT00107653|144238095|SUPERIORITY_OR_OTHER||Study Group Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.04|<|0.0001|TWO_SIDED|95.0|-0.24|-0.09|||Normal approximation to the binomial.||The estimated value is the difference in proportion of participants (Latino minus Non-Latino White) with virologic response. The 95% Confidence Interval is based on normal approximation to the binomial.|Virologic Response for Latino VS Non-Latino White at Week 48||-0.09|-0.24|<0.0001
72363499|NCT00107653|144238095|SUPERIORITY_OR_OTHER||Study Group Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.041|<|0.0001|TWO_SIDED|95.0|-0.25|-0.09|||Normal approximation to the binomial.||The estimated value is the difference in proportion of participants (Latino minus Non-Latino White) with virologic response. The 95% Confidence Interval is based on normal approximation to the binomial.|Virologic Response for Latino VS Non-Latino White at Week 60||-0.09|-0.25|<0.0001
72363500|NCT00107653|144238095|SUPERIORITY_OR_OTHER||Study Group Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.041|<|0.0001|TWO_SIDED|95.0|-0.24|-0.08|||Normal approximation to the binomial.||The estimated value is the difference in proportion of participants (Latino minus Non-Latino White) with virologic response. The 95% Confidence Interval is based on normal approximation to the binomial.|Virologic Response for Latino VS Non-Latino White at Week 72||-0.08|-0.24|<0.0001
72363501|NCT00107653|144238096|SUPERIORITY_OR_OTHER||Study Group Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.036||0.0353|TWO_SIDED|95.0|-0.15|-0.01|||Normal approximation to the binomial.||The estimated value is the Difference in proportion of participants (Latino minus Non-Latino White) with virologic response. the 95% Confidence Interval is based on normal approximation to the binomial.|Virologic Response for Latino VS Non-Latino White at Week 4||-0.01|-0.15|0.0353
72363502|NCT00107653|144238097|SUPERIORITY_OR_OTHER||Study Group Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.033||0.0014|TWO_SIDED|95.0|-0.17|-0.04|||Normal approximation to the binomial.||The estimated value is the difference in proportion of participants (Latino minus Non-Latino White) with virologic response. The 95% Confidence Interval is based on normal approximation to the binomial.|Virologic Response for Latino VS Non-Latino White at Week 12||-0.04|-0.17|0.0014
72363503|NCT00107653|144238099|SUPERIORITY_OR_OTHER||Study Group Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.042||0.0006|TWO_SIDED|95.0|-0.22|-0.06|||Normal approximation to the binomial.||The estimated value is the difference in proportion of participants (Latino minus Non-Latino White) with biochemical response. The 95% Confidence Interval is based on normal approximation to the binomial.|Normal Serum ALT level for Latino VS Non-Latino White at Week 4||-0.06|-0.22|0.0006
72363504|NCT00107653|144238099|SUPERIORITY_OR_OTHER||Study Group Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.04|<|0.0001|TWO_SIDED|95.0|-0.24|-0.08|||Normal approximation to the binomial.||The estimated value is the difference in proportion of participants (Latino minus Non-Latino White) with biochemical response. The 95% Confidence Interval is based on normal approximation to the binomial.|Normal Serum ALT level for Latino VS Non-Latino White at Week 12||-0.08|-0.24|<0.0001
72429878|NCT00556374|144370925|SUPERIORITY_OR_OTHER_LEGACY||Difference from Placebo|7.92|||<|0.0001|TWO_SIDED|95.0|6.87|8.97||The Hochberg procedure was used to control for multiplicity.|ANCOVA|Model includes treatment group as the independent variable and adjusted for baseline value and the randomization stratification factors.||||8.97|6.87|<0.0001
72429879|NCT00556374|144370926|SUPERIORITY_OR_OTHER_LEGACY||Difference from Placebo|6.51|||<|0.0001|TWO_SIDED|95.0|5.62|7.39||The Hochberg procedure was used to control for multiplicity.|ANCOVA|Model includes treatment group as the independent variable and adjusted for baseline value and the randomization stratification factors.||||7.39|5.62|<0.0001
72429880|NCT00556374|144370927|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.53||||0.0088|TWO_SIDED|95.0|0.33|0.85|||Regression, Logistic|Logistic regression model includes treatment groups as the independent variable and stratified by the randomization stratification factors.|Values \< 1 for odds ratio favor denosumab.|||0.85|0.33|0.0088
72429881|NCT00556374|144370928|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.54||||0.007|TWO_SIDED|95.0|0.34|0.84|||Regression, Logistic|Logistic regression model includes treatment groups as the independent variable and stratified by the randomization stratification factors.|Values \< 1 for odds ratio favor denosumab.|||0.84|0.34|0.0070
72429882|NCT00556374|144370929|SUPERIORITY||Hazard Ratio (HR)|0.816||||0.0515|TWO_SIDED|95.0|0.66|1.0|||Cox Proportional Hazards Model|Stratified by randomization strata (hospital type, use of aromatase inhibitor, baseline lumbar spine BMD).|From the Cox Proportional hazards model with treatment fitted as a covariate and stratified by randomization strata. A hazard ratio \< 1.0 indicates a lower average event rate and a longer disease-free time for denosumab relative to placebo.|||1.00|0.66|0.0515
72429883|NCT00556374|144370930|SUPERIORITY|Analysis of BMFS was conditional on the outcome of DFS due to hierarchical testing strategy, therefore p-value not reported.|Hazard Ratio (HR)|0.808|||||TWO_SIDED|95.0|0.654|0.997|||||A hazard ratio \< 1.0 indicates a lower average event rate and a longer bone metastases-free time for denosumab relative to placebo.|||0.997|0.654|
72429884|NCT00556374|144370931|SUPERIORITY|Analysis of OS was conditional on the outcome of DFS due to hierarchical testing strategy, therefore p-value not reported.|Hazard Ratio (HR)|0.802|||||TWO_SIDED|95.0|0.635|1.013|||||A hazard ratio \< 1.0 indicates a lower average event rate and a longer overall survival time for denosumab relative to placebo.|||1.013|0.635|
72429885|NCT03077620|144370974|SUPERIORITY||Mean Difference (Final Values)|0.119|STANDARD_ERROR_OF_MEAN|0.064||0.05|TWO_SIDED|95.0|-0.017|0.256||Poor sleepers compared to good sleepers with Compound Symmetry covariance structure. Mean difference is poor sleepers minus good sleepers.|Mixed Models Analysis|||||0.256|-0.017|0.05
72429886|NCT03077620|144370975|SUPERIORITY||Mean Difference (Final Values)|0.004|STANDARD_ERROR_OF_MEAN|0.033||0.05|TWO_SIDED|95.0|-0.078|0.087||After corrected for multiple comparisons with Bonferroni test, treatment groups 1 and 2 compared to placebo with Compound Symmetry covariance structure. Mean difference is placebo minus treatment group.|Mixed Models Analysis|||||0.087|-0.078|0.05
72429887|NCT03077620|144370975|SUPERIORITY||Mean Difference (Final Values)|0.033|STANDARD_ERROR_OF_MEAN|0.033||0.05|TWO_SIDED|95.0|-0.051|0.117||After corrected for multiple comparisons with Bonferroni test, treatment groups 1 and 2 compared to placebo with Compound Symmetry covariance structure. Mean difference is placebo minus treatment group.|Mixed Models Analysis|||||0.117|-0.051|0.05
72429888|NCT02036515|144371000|SUPERIORITY_OR_OTHER||Difference in least squares mean|-0.69|||<|0.001|TWO_SIDED|95.0|-0.87|-0.5|||Constrained longitudinal data analysis|Model is fitted with effects for treatment, time, interaction of time by treatment, effects for baseline eGFR and prior antihyperglycemic medication||||-0.50|-0.87|<0.001
72429889|NCT02036515|144371000|SUPERIORITY_OR_OTHER||Difference in least squares mean|-0.76|||<|0.001|TWO_SIDED|95.0|-0.95|-0.58|||cLDA|Model is fitted with effects for treatment, time, interaction of time by treatment, effects for baseline eGFR and prior antihyperglycemic medication||||-0.58|-0.95|<0.001
72429890|NCT02036515|144371001|SUPERIORITY_OR_OTHER||Difference in percentage|-5.7|||||TWO_SIDED|95.0|-16.5|5.2||||||||5.2|-16.5|
72429891|NCT02036515|144371001|SUPERIORITY_OR_OTHER||Difference in percentage|-3.3|||||TWO_SIDED|95.0|-14.1|7.6||||||||7.6|-14.1|
72429892|NCT02036515|144371002|SUPERIORITY_OR_OTHER||Difference in percentage|0.6|||||TWO_SIDED|95.0|-4.4|5.6||||||||5.6|-4.4|
72429893|NCT02036515|144371002|SUPERIORITY_OR_OTHER||Difference in percentage|0.0|||||TWO_SIDED|95.0|-4.9|4.9||||||||4.9|-4.9|
72429894|NCT02036515|144371003|SUPERIORITY_OR_OTHER||Differenc in least squares means|-25.15|||<|0.001|TWO_SIDED|95.0|-32.76|-17.54|||cLDA|Model is fitted with effects for treatment, time, interaction of time by treatment, effects for baseline eGFR and prior antihyperglycemic medication||||-17.54|-32.76|<0.001
72429895|NCT02036515|144371003|SUPERIORITY_OR_OTHER||Difference in least squares means|-31.28|||<|0.001|TWO_SIDED|95.0|-38.9|-23.66|||cLDA|Model is fitted with effects for treatment, time, interaction of time by treatment, effects for baseline eGFR and prior antihyperglycemic medication||||-23.66|-38.90|<0.001
72429896|NCT02036515|144371004|SUPERIORITY_OR_OTHER||Difference in least squares means|-2.03|||<|0.001|TWO_SIDED|95.0|-2.65|-1.4|||cLDA|Model is fitted with effects for treatment, time, interaction of time by treatment, effects for baseline eGFR and prior antihyperglycemic medication||||-1.40|-2.65|<0.001
72429897|NCT02036515|144371004|SUPERIORITY_OR_OTHER||Difference in least squares means|-1.72|||<|0.001|TWO_SIDED|95.0|-2.35|-1.09|||cLDA|Model is fitted with effects for treatment, time, interaction of time by treatment, effects for baseline eGFR and prior antihyperglycemic medication||||-1.09|-2.35|<0.001
72429898|NCT02036515|144371005|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.16|||<|0.001|TWO_SIDED|95.0|1.74|5.72|||Regression, Logistic|Logistic regression model fitted with terms for treatment, baseline A1C, baseline eGFR and prior antihyperglycemic medication.||||5.72|1.74|<0.001
72429899|NCT02036515|144371005|SUPERIORITY_OR_OTHER||Difference in least squares means|4.43|||<|0.001|TWO_SIDED|95.0|2.44|8.02|||Regression, Logistic|Logistic regression model fitted with terms for treatment, baseline A1C, baseline eGFR and prior antihyperglycemic medication.||||8.02|2.44|<0.001
72429900|NCT02036515|144371006|SUPERIORITY_OR_OTHER||Difference in least squares means|-2.93||||0.019|TWO_SIDED|95.0|-5.36|-0.49|||cLDA|Model is fitted with effects for treatment, time, interaction of time by treatment, effects for baseline eGFR and prior antihyperglycemic medication||||-0.49|-5.36|0.019
72429901|NCT02036515|144371006|SUPERIORITY_OR_OTHER||Difference in least squares means|-3.94||||0.002|TWO_SIDED|95.0|-6.39|-1.5|||cLDA|Model is fitted with effects for treatment, time, interaction of time by treatment, effects for baseline eGFR and prior antihyperglycemic medication||||-1.50|-6.39|0.002
72368572|NCT02304367|144247145|OTHER|||||||0.664|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline P1NP.||Week 216||||0.664
72368573|NCT02304367|144247145|OTHER|||||||0.79|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline P1NP.||Week 240||||0.790
72368574|NCT02304367|144247146|OTHER|||||||0.05|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline osteocalcin.||Week 24||||0.050
72368575|NCT02304367|144247146|OTHER|||||||0.526|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline osteocalcin.||Week 48||||0.526
72368576|NCT02304367|144247146|OTHER|||||||0.845|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline osteocalcin.||Week 96||||0.845
72368577|NCT02304367|144247146|OTHER|||||||0.782|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline osteocalcin.||Week 144||||0.782
72368578|NCT02304367|144247146|OTHER|||||||0.02|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline osteocalcin.||Week 168||||0.020
72368579|NCT02304367|144247146|OTHER|||||||0.005|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline osteocalcin.||Week 192||||0.005
72368580|NCT02304367|144247146|OTHER|||||||0.136|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline osteocalcin.||Week 216||||0.136
72368581|NCT02304367|144247146|OTHER|||||||0.101|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline osteocalcin.||Week 240||||0.101
72368582|NCT02304367|144247147|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline osteocalcin.||Week 24||||< 0.001
72368583|NCT02304367|144247147|OTHER|||||||0.238|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline osteocalcin.||Week 48||||0.238
72368584|NCT02304367|144247147|OTHER|||||||0.286|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline osteocalcin.||Week 96||||0.286
72368585|NCT02304367|144247147|OTHER|||||||0.093|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline osteocalcin.||Week 144||||0.093
72368586|NCT02304367|144247147|OTHER|||||||0.89|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline osteocalcin.||Week 168||||0.890
72368587|NCT02304367|144247147|OTHER|||||||0.059|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline osteocalcin.||Week 192||||0.059
72368588|NCT02304367|144247147|SUPERIORITY|||||||0.623||||||Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline osteocalcin.|GEE model|||Week 216||||0.623
72368589|NCT02304367|144247147|OTHER|||||||0.411|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline osteocalcin.||Week 240||||0.411
72368590|NCT02304367|144247148|OTHER|||||||0.8209|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 24||||0.8209
72368591|NCT02304367|144247148|OTHER|||||||0.2851|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 24||||0.2851
72368592|NCT02304367|144247148|OTHER|||||||0.6689|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 48||||0.6689
72368593|NCT02304367|144247148|OTHER|||||||0.1612|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 48||||0.1612
72368594|NCT02304367|144247149|OTHER|||||||0.4093|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 24||||0.4093
72368595|NCT02304367|144247149|OTHER|||||||0.572|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 24||||0.5720
72368596|NCT02304367|144247149|OTHER|||||||0.3501|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 48||||0.3501
72368597|NCT02304367|144247149|OTHER|||||||0.5172|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 48||||0.5172
72368598|NCT02304367|144247150|OTHER|||||||0.0046|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline STS measurement.||Week 24||||0.0046
72368599|NCT02304367|144247150|OTHER|||||||0.0012|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline STS measurement.||Week 48||||0.0012
72368600|NCT02304367|144247151|OTHER|||||||0.6475|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 24||||0.6475
72368601|NCT02304367|144247151|OTHER|||||||0.5319|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 24||||0.5319
72368602|NCT02304367|144247151|OTHER|||||||0.9206|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 48||||0.9206
72368603|NCT02304367|144247151|OTHER|||||||0.153|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 48||||0.1530
72368604|NCT02304367|144247152|OTHER|||||||0.2125|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 24||||0.2125
72368605|NCT02304367|144247152|OTHER|||||||0.1241|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 48||||0.1241
72368606|NCT02304367|144247153|OTHER|||||||0.41|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 24||||0.410
72429902|NCT02036515|144371007|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.76|||||TWO_SIDED|95.0|-0.98|-0.54||||||||-0.54|-0.98|
72368607|NCT02304367|144247153|OTHER|||||||0.21|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 48||||0.210
72368608|NCT02304367|144247153|OTHER|||||||0.06|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 96||||0.060
72368609|NCT02304367|144247153|OTHER|||||||0.076|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 144||||0.076
72368610|NCT02304367|144247153|OTHER|||||||0.171|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 168||||0.171
72368611|NCT02304367|144247153|OTHER|||||||0.141|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 192||||0.141
72368612|NCT02304367|144247153|OTHER|||||||0.263|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 216||||0.263
72368613|NCT02304367|144247153|OTHER|||||||0.32|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 240||||0.320
72368614|NCT02304367|144247154|OTHER|||||||0.407|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 24||||0.407
72368615|NCT02304367|144247154|OTHER|||||||0.192|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 48||||0.192
72368616|NCT02304367|144247154|OTHER|||||||0.106|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 96||||0.106
72368617|NCT02304367|144247154|OTHER|||||||0.02|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 144||||0.020
72368618|NCT02304367|144247154|OTHER|||||||0.002|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 168||||0.002
72368619|NCT02304367|144247154|OTHER|||||||0.22|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 192||||0.220
72368620|NCT02304367|144247154|OTHER|||||||0.23|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 216||||0.230
72368621|NCT02304367|144247154|OTHER|||||||0.232|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 240||||0.232
72368622|NCT02304367|144247155|OTHER|||||||0.082|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 24||||0.082
72368623|NCT02304367|144247155|OTHER|||||||0.176|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 48||||0.176
72368624|NCT02304367|144247155|OTHER|||||||0.047|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 96||||0.047
72368625|NCT02304367|144247155|OTHER|||||||0.017|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 144||||0.017
72368626|NCT02304367|144247155|OTHER|||||||0|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 168||||0.000
72368627|NCT02304367|144247155|OTHER|||||||0.057|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 192||||0.057
72368628|NCT02304367|144247155|OTHER|||||||0.071|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 216||||0.071
72368629|NCT02304367|144247155|OTHER|||||||0.07|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 240||||0.070
72368630|NCT02304367|144247156|OTHER|||||||0.014|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 24||||0.014
72368631|NCT02304367|144247156|OTHER|||||||0.309|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 48||||0.309
72368632|NCT02304367|144247156|OTHER|||||||0.036|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 96||||0.036
72368633|NCT02304367|144247156|OTHER|||||||0.096|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 144||||0.096
72368634|NCT02304367|144247156|OTHER|||||||0.005|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 168||||0.005
72368635|NCT02304367|144247156|OTHER|||||||0.022|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 192||||0.022
72368636|NCT02304367|144247156|OTHER|||||||0.022|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 216||||0.022
72368637|NCT02304367|144247156|OTHER|||||||0.004|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 240||||0.004
72368638|NCT02304367|144247157|OTHER|||||||0.005|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 24||||0.005
72368639|NCT02304367|144247157|OTHER|||||||0.019|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 48||||0.019
72368640|NCT02304367|144247157|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 96||||< 0.001
72368641|NCT02304367|144247157|OTHER|||||||0.006|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 144||||0.006
72368642|NCT02304367|144247157|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 168||||< 0.001
72368643|NCT02304367|144247157|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 192||||< 0.001
72368644|NCT02304367|144247157|OTHER|||||||0.002|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 216||||0.002
72368645|NCT02304367|144247157|OTHER|||||||0.002|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 240||||0.002
72368646|NCT02304367|144247158|OTHER|||||||0.016|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 24||||0.016
72368647|NCT02304367|144247158|OTHER|||||||0.004|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 48||||0.004
72368648|NCT02304367|144247158|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 96||||< 0.001
72368649|NCT02304367|144247158|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 144||||< 0.001
72368650|NCT02304367|144247158|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 168||||< 0.001
72368651|NCT02304367|144247158|OTHER|||||||0.036|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 192||||0.036
72368652|NCT02304367|144247158|OTHER|||||||0.008|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 216||||0.008
72368653|NCT02304367|144247158|OTHER|||||||0.008|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 240||||0.008
72368654|NCT02304367|144247159|OTHER|||||||0.006|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 24||||0.006
72368655|NCT02304367|144247159|OTHER|||||||0.003|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 48||||0.003
72368656|NCT02304367|144247159|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 96||||<0.001
72368657|NCT02304367|144247159|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 144||||< 0.001
72368658|NCT02304367|144247159|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 168||||< 0.001
72368659|NCT02304367|144247159|SUPERIORITY|||||||0.007|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 192||||0.007
72368660|NCT02304367|144247159|OTHER|||||||0.005|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 216||||0.005
72368661|NCT02304367|144247159|OTHER|||||||0.006|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 240||||0.006
72368662|NCT02304367|144247160|OTHER|||||||0.009|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 24||||0.009
72368663|NCT02304367|144247160|OTHER|||||||0.02|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 48||||0.020
72368664|NCT02304367|144247160|OTHER|||||||0.044|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 96||||0.044
72368665|NCT02304367|144247160|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 144||||< 0.001
72368666|NCT02304367|144247160|OTHER|||||||0.015|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 168||||0.015
72368667|NCT02304367|144247160|OTHER|||||||0.125|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 192||||0.125
72368668|NCT02304367|144247160|OTHER|||||||0.004|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 216||||0.004
72368669|NCT02304367|144247160|OTHER|||||||0.018|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 240||||0.018
72368670|NCT02304367|144247161|OTHER|||||||0.148|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 24||||0.148
72368671|NCT02304367|144247161|OTHER|||||||0.295|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 48||||0.295
72368672|NCT02304367|144247161|OTHER|||||||0.005|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 96||||0.005
72368673|NCT02304367|144247161|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 144||||< 0.001
72368674|NCT02304367|144247161|OTHER|||||||0.014|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 168||||0.014
72368675|NCT02304367|144247161|OTHER|||||||0.14|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 192||||0.140
72368676|NCT02304367|144247161|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 216||||< 0.001
72368677|NCT02304367|144247161|OTHER|||||||0.142|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 240||||0.142
72368678|NCT02304367|144247162|OTHER|||||||0.005|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 24||||0.005
72368679|NCT02304367|144247162|OTHER|||||||0.077|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 48||||0.077
72368680|NCT02304367|144247162|OTHER|||||||0.046|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 96||||0.046
72368681|NCT02304367|144247162|OTHER|||||||0.049|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 144||||0.049
72368682|NCT02304367|144247162|OTHER|||||||0.003|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 168||||0.003
72368683|NCT02304367|144247162|OTHER|||||||0.073|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 192||||0.073
72368684|NCT02304367|144247162|OTHER|||||||0.109|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 216||||0.109
72368685|NCT02304367|144247162|OTHER|||||||0.006|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 240||||0.006
72368686|NCT02304367|144247163|OTHER|||||||0.328|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 24||||0.328
72368687|NCT02304367|144247163|OTHER|||||||0.015|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 48||||0.015
72368688|NCT02304367|144247163|OTHER|||||||0.02|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 96||||0.020
72368689|NCT02304367|144247163|OTHER|||||||0.004|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 144||||0.004
72368690|NCT02304367|144247163|OTHER|||||||0.021|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 168||||0.021
72368691|NCT02304367|144247163|OTHER|||||||0.08|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 192||||0.080
72368692|NCT02304367|144247163|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 216||||< 0.001
72368693|NCT02304367|144247163|OTHER|||||||0.003|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 240||||0.003
72368694|NCT02304367|144247164|OTHER|||||||0.207|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 24||||0.207
72368695|NCT02304367|144247164|OTHER|||||||0.008|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 48||||0.008
72368696|NCT02304367|144247164|OTHER|||||||0.598|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 96||||0.598
72368697|NCT02304367|144247164|OTHER|||||||0.237|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 144||||0.237
72368698|NCT02304367|144247164|OTHER|||||||0.899|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 168||||0.899
72368699|NCT02304367|144247164|OTHER|||||||0.585|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 192||||0.585
72368700|NCT02304367|144247164|OTHER|||||||0.461|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 216||||0.461
72368701|NCT02304367|144247164|OTHER|||||||0.583|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 240||||0.583
72368702|NCT02304367|144247165|OTHER|||||||0.654|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 24||||0.654
72368703|NCT02304367|144247165|OTHER|||||||0.579|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 48||||0.579
72368704|NCT02304367|144247165|OTHER|||||||0.123|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 96||||0.123
72368705|NCT02304367|144247165|OTHER|||||||0.712|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 144||||0.712
72368706|NCT02304367|144247165|OTHER|||||||0.258|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 168||||0.258
72368707|NCT02304367|144247165|OTHER|||||||0.851|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 192||||0.851
72368708|NCT02304367|144247165|OTHER|||||||0.849|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 216||||0.849
72368709|NCT02304367|144247165|OTHER|||||||0.153|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 240||||0.153
72368710|NCT02304367|144247166|OTHER|||||||0.002|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 24||||0.002
72429903|NCT02036515|144371007|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.83|||||TWO_SIDED|95.0|-1.05|-0.61||||||||-0.61|-1.05|
72429904|NCT02036515|144371008|SUPERIORITY_OR_OTHER||Difference in least squares means|-28.76|||||TWO_SIDED|95.0|-36.44|-21.09||||||||-21.09|-36.44|
72429905|NCT02036515|144371008|SUPERIORITY_OR_OTHER||Difference in least squares means|-29.58|||||TWO_SIDED|95.0|-37.3|-21.85||||||||-21.85|-37.30|
72429906|NCT02036515|144371009|SUPERIORITY_OR_OTHER||Difference in least squares means|-2.51|||||TWO_SIDED|95.0|-3.43|-1.59||||||||-1.59|-3.43|
72429907|NCT02036515|144371009|SUPERIORITY_OR_OTHER||Difference in least squares means|-1.88|||||TWO_SIDED|95.0|-2.81|-0.95||||||||-0.95|-2.81|
72429908|NCT02036515|144371010|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.63|||||TWO_SIDED|95.0|1.98|6.64||||||||6.64|1.98|
72429909|NCT02036515|144371010|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.02|||||TWO_SIDED|95.0|2.22|7.28||||||||7.28|2.22|
72429910|NCT02036515|144371011|SUPERIORITY_OR_OTHER||Difference in least squares means|-4.99|||||TWO_SIDED|95.0|-7.82|-2.15||||||||-2.15|-7.82|
72429911|NCT02036515|144371011|SUPERIORITY_OR_OTHER||Difference in least squares means|-4.92|||||TWO_SIDED|95.0|-7.76|-2.07||||||||-2.07|-7.76|
72429912|NCT02036515|144371012|SUPERIORITY_OR_OTHER||Difference in least squares means|-1.24|||||TWO_SIDED|95.0|-2.97|0.48||||||||0.48|-2.97|
72429913|NCT02036515|144371012|SUPERIORITY_OR_OTHER||Difference in least squares means|-1.38|||||TWO_SIDED|95.0|-3.11|0.36||||||||0.36|-3.11|
72429914|NCT02036515|144371013|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.99|||||TWO_SIDED|95.0|-2.82|0.84||||||||0.84|-2.82|
72429915|NCT02036515|144371013|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.85|||||TWO_SIDED|95.0|-2.69|0.99||||||||0.99|-2.69|
72429916|NCT02036515|144371014|SUPERIORITY_OR_OTHER||Difference in percent|-15.1|||||TWO_SIDED|95.0|-21.9|-9.4||||||||-9.4|-21.9|
72429917|NCT02036515|144371014|SUPERIORITY_OR_OTHER||Difference in percent|-14.4|||||TWO_SIDED|95.0|-21.3|-8.5||||||||-8.5|-21.3|
72429918|NCT02036515|144371015|SUPERIORITY_OR_OTHER||Difference in percentage|-29.0|||||TWO_SIDED|95.0|-38.3|-19.4||||||||-19.4|-38.3|
72429919|NCT02036515|144371015|SUPERIORITY_OR_OTHER||Difference in percentage|-28.1|||||TWO_SIDED|95.0|-37.5|-18.4||||||||-18.4|-37.5|
72429920|NCT02036515|144371019|SUPERIORITY_OR_OTHER||Difference in least squares means|12.75|||||TWO_SIDED|95.0|6.83|18.68||||||||18.68|6.83|
72429921|NCT02036515|144371019|SUPERIORITY_OR_OTHER||Difference in least squares means|11.91|||||TWO_SIDED|95.0|5.94|17.88||||||||17.88|5.94|
72429922|NCT02036515|144371020|SUPERIORITY_OR_OTHER||Difference in least squares means|12.78|||||TWO_SIDED|95.0|6.54|19.03||||||||19.03|6.54|
72429923|NCT02036515|144371020|SUPERIORITY_OR_OTHER||Difference in least squares means|12.86|||||TWO_SIDED|95.0|6.54|19.18||||||||19.18|6.54|
72429924|NCT02036515|144371022|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.01|||||TWO_SIDED|95.0|-0.04|0.02||||||||0.02|-0.04|
72429925|NCT02036515|144371022|SUPERIORITY_OR_OTHER||Difference in least squares means|0.01|||||TWO_SIDED|95.0|-0.02|0.04||||||||0.04|-0.02|
72429926|NCT02036515|144371023|SUPERIORITY_OR_OTHER||Difference in least squares means|0.0|||||TWO_SIDED|95.0|-0.04|0.04||||||||0.04|-0.04|
72429927|NCT02036515|144371023|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.02|||||TWO_SIDED|95.0|-0.07|0.02||||||||0.02|-0.07|
72429928|NCT02102464|144371031|SUPERIORITY||Mean Difference (Final Values)|11.0|||<|0.0001|TWO_SIDED|95.0|8.0|14.0|||t-test, 2 sided|||||14.0|8.0|<0.0001
72429929|NCT02102464|144371032|SUPERIORITY||Mean Difference (Final Values)|-7.7|||<|0.0001|TWO_SIDED|95.0|-10.2|-5.2|||t-test, 2 sided|||||-5.2|-10.2|<0.0001
72429930|NCT02102464|144371033|SUPERIORITY||Mean Difference (Final Values)|3.9|||<|0.0001|TWO_SIDED|95.0|2.5|5.4|||t-test, 2 sided|||||5.4|2.5|<0.0001
72429931|NCT00950937|144371056|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Wilcoxon (Mann-Whitney)|Wilcoxon test was utilized to compare the three moments: baseline vs. aerobic, baseline vs. resistance and aerobic vs. resistance.||||||<0.05
72429932|NCT00950937|144371056|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Friedman Test|Friedman to compare: baseline vs. aerobic, baseline vs. resistance and aerobic vs. resistance. Wilcoxon was applied to locate the differences||||||<0.05
72429933|NCT00950937|144371056|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Friedman Test|Friedman to compare: baseline vs. aerobic, baseline vs. resistance and aerobic vs. resistance. Wilcoxon was applied to locate the differences||||||<0.05
72429934|NCT00950937|144371057|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Wilcoxon (Mann-Whitney)|Wilcoxon test was utilized to compare the three moments: baseline vs. aerobic, baseline vs. resistance and aerobic vs. resistance.||||||<0.05
72429935|NCT00950937|144371057|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Friedman Test|Friedman to compare: baseline vs. aerobic, baseline vs. resistance and aerobic vs. resistance. Wilcoxon was applied to locate the differences||||||<0.05
72429936|NCT00950937|144371057|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Friedman Test|Friedman to compare: baseline vs. aerobic, baseline vs. resistance and aerobic vs. resistance. Wilcoxon was applied to locate the differences||||||<0.05
72429937|NCT00950937|144371058|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Wilcoxon (Mann-Whitney)|Wilcoxon test was utilized to compare the three moments: baseline vs. aerobic, baseline vs. resistance and aerobic vs. resistance.||||||<0.05
72429938|NCT00950937|144371058|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Friedman Test|Friedman to compare: baseline vs. aerobic, baseline vs. resistance and aerobic vs. resistance. Wilcoxon was applied to locate the differences||||||<0.05
72429939|NCT00950937|144371058|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Friedman Test|Friedman to compare: baseline vs. aerobic, baseline vs. resistance and aerobic vs. resistance. Wilcoxon was applied to locate the differences||||||<0.05
72429940|NCT00950937|144371059|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Wilcoxon (Mann-Whitney)|Wilcoxon test was utilized to compare the three moments: baseline vs. aerobic, baseline vs. resistance and aerobic vs. resistance.||||||<0.05
72429941|NCT00950937|144371059|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Friedman Test|Friedman to compare: baseline vs. aerobic, baseline vs. resistance and aerobic vs. resistance. Wilcoxon was applied to locate the differences||||||<0.05
72429942|NCT00950937|144371059|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Friedman Test|Friedman to compare: baseline vs. aerobic, baseline vs. resistance and aerobic vs. resistance. Wilcoxon was applied to locate the differences||||||<0.05
72429943|NCT00950937|144371060|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Wilcoxon (Mann-Whitney)|Wilcoxon test was utilized to compare the three moments: baseline vs. aerobic, baseline vs. resistance and aerobic vs. resistance.||||||<0.05
72429944|NCT00950937|144371060|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Friedman Test|Friedman to compare: baseline vs. aerobic, baseline vs. resistance and aerobic vs. resistance. Wilcoxon was applied to locate the differences||||||<0.05
72429945|NCT00950937|144371060|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Friedman Test|Friedman to compare: baseline vs. aerobic, baseline vs. resistance and aerobic vs. resistance. Wilcoxon was applied to locate the differences||||||<0.05
72429946|NCT00950937|144371061|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Wilcoxon (Mann-Whitney)|Wilcoxon test was utilized to compare the three moments: baseline vs. aerobic, baseline vs. resistance and aerobic vs. resistance.||||||<0.05
72429947|NCT00950937|144371061|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Friedman Test|Friedman to compare: baseline vs. aerobic, baseline vs. resistance and aerobic vs. resistance. Wilcoxon was applied to locate the differences||||||<0.05
72429948|NCT00950937|144371061|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Friedman Test|Friedman to compare: baseline vs. aerobic, baseline vs. resistance and aerobic vs. resistance. Wilcoxon was applied to locate the differences||||||<0.05
72429949|NCT00950937|144371062|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||t-test, 2 sided|Paired t-test was utilized to compare the two groups (HIV group and Control group)||||||<0.05
72429950|NCT01824472|144371063|SUPERIORITY||Mean difference compared across 3 groups|0.43||||0.8|TWO_SIDED||||||Kruskal-Wallis||"Kruskal-Wallis test implemented as PROC NPAR1WAY in Statistical Analysis System (SAS v9.4) for a single groupwise comparison. The mean difference (baseline to follow-up) was determined for each group, and this was compared across all 3 groups."|||||0.8
72429951|NCT01815736|144371069|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Null hypothesis: the E/C/F/TAF group was at least 12% worse than the Stay on Baseline Regimen group; alternative hypothesis: the E/C/F/TAF group was less than 12% worse than the in Stay on Baseline Regimen group.|Difference in percentages|2.7||||0.051|TWO_SIDED|95.01|-0.3|5.6||The p-value for the superiority test used a 2-sided Cochran-Mantel-Haenszel (CMH) test, stratified by prior treatment regimen.|Cochran-Mantel-Haenszel||The difference in percentages and its 95.01% confidence interval (CI) were calculated based on the Mantel-Haenszel (MH) proportion adjusted by the prior treatment regimen.|NDA Data Cut||5.6|-0.3|0.051
72429952|NCT01815736|144371069|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Null hypothesis: the E/C/F/TAF group was at least 12% worse than the Stay on Baseline Regimen group; alternative hypothesis: the E/C/F/TAF group was less than 12% worse than the in Stay on Baseline Regimen group.|Difference in percentages|4.1|||<|0.001|TWO_SIDED|95.0|1.6|6.7||The p-value for the superiority test used a 2-sided Cochran-Mantel-Haenszel (CMH) test, stratified by prior treatment regimen.|Cochran-Mantel-Haenszel||The difference in percentages and its 95% confidence interval (CI) were calculated based on the Mantel-Haenszel (MH) proportion adjusted by the prior treatment regimen.|All Participants||6.7|1.6|<0.001
72429953|NCT01815736|144371070|SUPERIORITY_OR_OTHER_LEGACY||Difference in least square means|2.078|||<|0.001|TWO_SIDED|95.0|1.697|2.459||P-value was from the analysis of variance (ANOVA) model including study treatment and prior treatment regimen as fixed effects.|ANOVA||Difference in least squares means (LSM) and its 95% CI were from the ANOVA model including treatment and prior treatment regimen as fixed effects.|NDA Data Cut||2.459|1.697|<0.001
72429954|NCT01815736|144371070|SUPERIORITY_OR_OTHER_LEGACY||Difference in least square means|1.807|||<|0.001|TWO_SIDED|95.0|1.488|2.126||P-value was from the analysis of variance (ANOVA) model including study treatment and prior treatment regimen as fixed effects.|ANOVA||Difference in least squares means and its 95% CI were from the ANOVA model including treatment and prior treatment regimen as fixed effects.|All Participants||2.126|1.488|<0.001
72429955|NCT01815736|144371071|SUPERIORITY_OR_OTHER_LEGACY||Difference in least square means|1.97|||<|0.001|TWO_SIDED|95.0|1.551|2.39||P-value was from the analysis of variance (ANOVA) model including study treatment and prior treatment regimen as fixed effects.|ANOVA||Difference in least squares means (LSM) and its 95% CI were from the ANOVA model including treatment and prior treatment regimen as fixed effects.|NDA Data Cut||2.390|1.551|<0.001
72363505|NCT00107653|144238099|SUPERIORITY_OR_OTHER||Study Group Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.041||0.0003|TWO_SIDED|95.0|-0.23|-0.07|||Normal approximation to the binomial.||The estimated value is the difference in proportion of participants (Latino minus Non-Latino White) with biochemical response. The 95% Confidence Interval is based on normal approximation to the binomial.|Normal Serum ALT level for Latino VS Non-Latino White at Week 24||-0.07|-0.23|0.0003
72368711|NCT02304367|144247166|OTHER|||||||0.03|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 48||||0.030
72368712|NCT02304367|144247166|OTHER|||||||0.011|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 96||||0.011
72368713|NCT02304367|144247166|OTHER|||||||0.186|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 144||||0.186
72368714|NCT02304367|144247166|OTHER|||||||0.027|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 168||||0.027
72368715|NCT02304367|144247166|OTHER|||||||0.33|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 192||||0.330
72368716|NCT02304367|144247166|OTHER|||||||0.072|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 216||||0.072
72368717|NCT02304367|144247166|OTHER|||||||0.045|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 240||||0.045
72368718|NCT02304367|144247167|OTHER|||||||0.369|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 24||||0.369
72368719|NCT02304367|144247167|OTHER|||||||0.026|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 48||||0.026
72368720|NCT02304367|144247167|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 96||||< 0.001
72368721|NCT02304367|144247167|OTHER|||||||0.235|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 144||||0.235
72363506|NCT00107653|144238099|SUPERIORITY_OR_OTHER||Study Group Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.042||0.0008|TWO_SIDED|95.0|-0.22|-0.06|||Normal approximation to the binomial.||The estimated value is the difference in proportion of participants (Latino minus Non-Latino White) with biochemical response. The 95% Confidence Interval is based on normal approximation to the binomial.|Normal Serum ALT level for Latino VS Non-Latino White at Week 48||-0.06|-0.22|0.0008
72363507|NCT00107653|144238099|SUPERIORITY_OR_OTHER||Study Group Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.041|<|0.0001|TWO_SIDED|95.0|-0.26|-0.1|||Normal approximation to the binomial.||The estimated value is the difference in proportion of participants (Latino minus Non-Latino White) with biochemical response. The 95% Confidence Interval is based on normal approximation to the binomial.|Normal Serum ALT level for Latino VS Non-Latino White at Week 60||-0.10|-0.26|<0.0001
72363508|NCT00107653|144238099|SUPERIORITY_OR_OTHER||Study Group Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.041|<|0.0001|TWO_SIDED|95.0|-0.27|-0.11|||Normal approximation to the binomial.||The estimated value is the difference in proportion of participants (Latino minus Non-Latino White) with biochemical response. The 95% Confidence Interval is based on normal approximation to the binomial.|Normal Serum ALT level for Latino VS Non-Latino White at Week 72||-0.11|-0.27|<0.0001
72363509|NCT00107653|144238100|SUPERIORITY_OR_OTHER||Study Group Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.05||0.0285|TWO_SIDED|95.0|-0.2|0.0|||Normal approximation to the binomial.||The estimated value is the difference in proportion of participants (Latino minus Non-Latino White) with ISHAK HAI response. The 95% Confidence Interval is based on normal approximation to the binomial.|ISHAK HAI Response For Latino VS Non-Latino White||-0.0|-0.2|0.0285
72363510|NCT00107653|144238101|SUPERIORITY_OR_OTHER||Study Group Difference|0.9|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001|TWO_SIDED|95.0|0.5|1.3|||Normal approximation to the binomial.||The estimated value is the difference in change from baseline of ISHAK HAI activity (necroinflammatory) scores between Latino and Non-Latino White participants. The 95% Confidence Interval is based on normal approximation to the binomial.|ISHAK HAI activity For Latino VS Non-Latino White||1.3|0.5|<0.0001
72363511|NCT00107653|144238110|SUPERIORITY_OR_OTHER||Study Group Difference|-0.65|STANDARD_ERROR_OF_MEAN|0.162|<|0.0001|TWO_SIDED|95.0|-0.96|-0.33|||ANCOVA||The estimated value is the difference of change from baseline in FSS scores at week 48 between Latino and Non-Latino White participants. The 95% Confidence Interval is based on normal approximation to the binomial.|FSS Score of Latino VS Non-Latino White at week 48||-0.33|-0.96|<0.0001
72363512|NCT00107653|144238110|SUPERIORITY_OR_OTHER||Study Group Difference|-0.26|STANDARD_ERROR_OF_MEAN|0.156||0.0921|TWO_SIDED|95.0|-0.57|0.04|||ANCOVA||The estimated value is the difference of change from baseline in FSS scores at week 72 between Latino and Non-Latino White participants. The 95% Confidence Interval is based on normal approximation to the binomial.|FSS Score of Latino VS Non-Latino White at week 72||0.04|-0.57|0.0921
72363513|NCT00107653|144238110|SUPERIORITY_OR_OTHER||Study Group Difference|-8.72|STANDARD_ERROR_OF_MEAN|2.725||0.0015|TWO_SIDED|95.0|-14.07|-3.36|||ANCOVA||The estimated value is the difference of change from baseline in FSS VAS scores at week 48 between Latino and Non-Latino White participants The 95% Confidence Interval is based on normal approximation to the binomial.|FSS VAS Score of Latino VS Non-Latino White at week 48||-3.36|-14.07|0.0015
72363514|NCT00107653|144238110|SUPERIORITY_OR_OTHER||Study Group Difference|4.83|STANDARD_ERROR_OF_MEAN|2.37||0.0421|TWO_SIDED|95.0|0.18|9.49|||ANCOVA||The estimated value is the difference of change from baseline in FSS VAS scores at week 72 between Latino and Non-Latino White participants. The 95% Confidence Interval is based on normal approximation to the binomial.|FSS VAS Score of Latino VS Non-Latino White at week 72||9.49|0.18|0.0421
72363515|NCT00107653|144238111|SUPERIORITY_OR_OTHER||Study Group Difference|3.49|STANDARD_ERROR_OF_MEAN|0.864|<|0.0001|TWO_SIDED|95.0|1.79|5.18|||ANCOVA||The estimated value is the difference of change from baseline in standardized physical component score at week 48 between Latino and Non-Latino White participants. The 95% Confidence Interval is based on normal approximation to the binomial.|Standardized Physical Component of Latino VS Non-Latino White at week 48||5.18|1.79|<0.0001
72363516|NCT00107653|144238111|SUPERIORITY_OR_OTHER||Study Group Difference|0.1|STANDARD_ERROR_OF_MEAN|0.808||0.9047|TWO_SIDED|95.0|-1.49|1.68|||ANCOVA||The estimated value is the difference of change from baseline in standardized physical component score at week 48 between Latino and Non-Latino White participants. The 95% Confidence Interval is based on normal approximation to the binomial.|Standardized Physical Component of Latino VS Non-Latino White at week 72||1.68|-1.49|0.9047
72363517|NCT00107653|144238111|SUPERIORITY_OR_OTHER||Study Group Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.914||0.9286|TWO_SIDED|95.0|-1.88|1.71|||ANCOVA||The estimated value is the difference of change from baseline in standardized mental component score at week 48 between Latino and Non-Latino White participants. The 95% Confidence Interval is based on normal approximation to the binomial.|Standardized Mental Component of Latino VS Non-Latino White at week 48||1.71|-1.88|0.9286
72363518|NCT00107653|144238111|SUPERIORITY_OR_OTHER||Study Group Difference|-1.23|STANDARD_ERROR_OF_MEAN|0.888||0.1653|TWO_SIDED|95.0|-2.98|0.51|||ANCOVA||The estimated value is the difference of change from baseline in standardized mental component score at week 72 between Latino and Non-Latino White participants. The 95% Confidence Interval is based on normal approximation to the binomial.|Standardized Mental Component of Latino VS Non-Latino White at week 72||0.51|-2.98|0.1653
72363519|NCT05720897|144238131|SUPERIORITY|||||||0.399||||||The calculations are based on a Mann Whitney calculation.|Wilcoxon (Mann-Whitney)|||The study has an 80% power to detect changes in patient's self-reported anxiety as measured by their responses to the psychometrically validated STAI-S \& T instrument of 3.6 within each group (with an effect size of 0.55) and differences of a 5.0 between groups (with an effect size of 0.77).||||.399
72363520|NCT04780061|144238137|SUPERIORITY|||||||0.53|||||||t-test, 2 sided|||An area under the curve approach was used to analyze the primary outcome, whereby participants' scores for each assessment were summed over the 21-day period. For missing values, we imputed the mean of the most recent and first subsequent measurement or carried the last observation forward if there was no subsequent measurement.||||0.53
72363521|NCT04780061|144238139|SUPERIORITY|||||||0.09|||||||t-test, 2 sided|||||||0.09
72363522|NCT04780061|144238140|SUPERIORITY|||||||0.81|||||||Log Rank|||||||0.81
72368722|NCT02304367|144247167|OTHER|||||||0.009|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 168||||0.009
72368723|NCT02304367|144247167|OTHER|||||||0.278|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 192||||0.278
72429956|NCT01815736|144371071|SUPERIORITY_OR_OTHER_LEGACY||Difference in least square means|2.0|||<|0.001|TWO_SIDED|95.0|1.549|2.452||P-value was from the analysis of variance (ANOVA) model including study treatment and prior treatment regimen as fixed effects.|ANOVA||Difference in least squares means (LSM) and its 95% CI were from the ANOVA model including treatment and prior treatment regimen as fixed effects.|All Participants||2.452|1.549|<0.001
72429957|NCT01815736|144371072|SUPERIORITY_OR_OTHER_LEGACY||Difference in least square means|-0.05|||<|0.001|TWO_SIDED|95.0|-0.07|-0.03||P-value was from analysis of covariance (ANCOVA) model including study treatment and prior treatment as fixed effects and baseline serum creatinine as a covariate.|ANCOVA||Difference in least squares means (LSM) and its 95% CI were from the analysis of covariance (ANCOVA) model including study treatment and prior treatment regimen as fixed effects and baseline serum creatinine as a covariate.|NDA Data Cut||-0.03|-0.07|<0.001
72429958|NCT01815736|144371072|SUPERIORITY_OR_OTHER_LEGACY||Difference in least square means|-0.04|||<|0.001|TWO_SIDED|95.0|-0.05|-0.02||P-value was from analysis of covariance (ANCOVA) model including study treatment and prior treatment as fixed effects and baseline serum creatinine as a covariate.|ANCOVA||Difference in least squares means (LSM) and its 95% CI were from the analysis of covariance (ANCOVA) model including study treatment and prior treatment regimen as fixed effects and baseline serum creatinine as a covariate.|All Participants||-0.02|-0.05|<0.001
72429959|NCT01815736|144371073|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||The P-value comparing the 2 treatment groups was from the 2-sided Wilcoxon rank sum test.|Wilcoxon (Mann-Whitney)|||NDA Data Cut||||<0.001
72368724|NCT02304367|144247167|OTHER|||||||0.046|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 216||||0.046
72368725|NCT02304367|144247167|OTHER|||||||0.035|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 240||||0.035
72368726|NCT02304367|144247168|OTHER|||||||0.442|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 24||||0.442
72368727|NCT02304367|144247168|OTHER|||||||0.677|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 48||||0.677
72368728|NCT02304367|144247168|OTHER|||||||0.027|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 96||||0.027
72368729|NCT02304367|144247168|OTHER|||||||0.42|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 144||||0.420
72368730|NCT02304367|144247168|SUPERIORITY|||||||0.027|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 168||||0.027
72368731|NCT02304367|144247168|OTHER|||||||0.312|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 192||||0.312
72368732|NCT02304367|144247168|OTHER|||||||0.249|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 216||||0.249
72368733|NCT02304367|144247168|OTHER|||||||0.102|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 240||||0.102
72368734|NCT02304367|144247169|OTHER|||||||0.856|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 24||||0.856
72368735|NCT02304367|144247169|OTHER|||||||0.898|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 48||||0.898
72368736|NCT02304367|144247169|OTHER|||||||0.785|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 96||||0.785
72368737|NCT02304367|144247169|OTHER|||||||0.932|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 144||||0.932
72368738|NCT02304367|144247169|OTHER|||||||0.545|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 168||||0.545
72368739|NCT02304367|144247169|OTHER|||||||0.58|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 192||||0.580
72368740|NCT02304367|144247169|OTHER|||||||0.462|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 216||||0.462
72368741|NCT02304367|144247169|OTHER|||||||0.26|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 240||||0.260
72368742|NCT02289157|144247204|OTHER||Risk Ratio (RR)|0.9||||0.54|TWO_SIDED|95.0|0.5|1.4|||Regression, Logistic|Ho: There is no difference between number of patients with wound complications between the study (icNPT) and comparison groups.||||1.4|0.5|0.54
72368743|NCT02289157|144247205|OTHER|||||||0.31|||||||Chi-squared|Pearson Chi-squared, df (3)||Ho: There is no difference between the types wound morbidity in the study (icNPT) and comparison groups.||||0.31
72368744|NCT02289157|144247206|OTHER|||||||0.54||||||Ho: There is no difference between initial length of stay between the study (icNPT) and comparison groups.|Wilcoxon (Mann-Whitney)|||||||0.54
72368745|NCT02289157|144247207|OTHER|||||||0.41|||||||Wilcoxon (Mann-Whitney)|||Ho: There is no difference in length of stay after readmission for wound morbidity between the study (icNPT) and comparison groups.||||0.41
72368746|NCT02289157|144247208|OTHER|||||||0.38|||||||Chi-squared|||Ho: There is no difference between the number of ER visits made per person between the study (icNPT) and comparison groups.||||0.38
72368747|NCT02289157|144247209|OTHER|||||||0.48||||||Ho: There is no difference between the number of visits made to the clinic for wound morbidity per patient between the study (icNPT) and comparison groups.|Chi-squared|||||||0.48
72368748|NCT02289157|144247210|OTHER|||||||0.52|||||||Wilcoxon (Mann-Whitney)|||Ho: There is no difference between number of readmissions between the study (icNPT) and comparison groups.||||0.52
72368749|NCT02289157|144247210|OTHER|||||||0.45|||||||Wilcoxon (Mann-Whitney)|||Ho: There is no difference in the use of post operative antimicrobials between the the study (icNPT) and comparison groups.||||0.45
72429960|NCT01815736|144371073|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||The P-value comparing the 2 treatment groups was from the 2-sided Wilcoxon rank sum test.|Wilcoxon (Mann-Whitney)|||All Participants||||<0.001
72363523|NCT02677493|144238165|EQUIVALENCE|"All statistical significance testing was performed at a two-sided significance level (α) of 5%.~Exceptionally, non-inferiority was tested at a one-sided CI of 97.5%."||||||0.09135|||||||ANCOVA|||To evaluate if the seroconversion (SCR) and seroprotection (SPR) rates on Day 28 after vaccination of IL-YANG Quadrivalent Influenza Vaccine Inj. meet the following criteria in all age groups of healthy male and female adults at the age of 19 or older.||||0.09135
72363524|NCT01456039|144238181|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Based on one sample binomial test for dichotomized response proportion against the null hypothesis ( H0 p≤0.1)|Binomial test for dichotomized response|||||||<0.0001
72363525|NCT00335777|144238209|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|2 sided McNemar test||||||0.289|TWO_SIDED|95.0|||||McNemar|2 sided McNemar||Null hypothesis: there is no difference in the proportion of subjects who were pain free when treating early, as compared to treating late.||||0.289
72363526|NCT00335777|144238210|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|2 sided McNemar test||||||1|||||||McNemar|2 sided McNemar test||Null hypothesis: there is no difference in the proportion of subjects who had pain relief when treating early, as compared to treating late.||||1.000
72363527|NCT03829228|144238228|SUPERIORITY||Mean Difference (Net)|1.31|||<|0.0001|TWO_SIDED|95.0|0.62|2.01||The threshold for statistical significance was p=0.01|ANOVA||Treatment Difference= Visit5-Baseline|||2.01|0.62|<0.0001
72363528|NCT03829228|144238229|SUPERIORITY||||||<|0.0001||||||The threshold for statistical significance was p=0.01|Regression, Logistic|||||||<0.0001
72363529|NCT03829228|144238230|SUPERIORITY||Mean Difference (Net)|1.31|||<|0.0001|TWO_SIDED|95.0|0.64|1.98||The threshold for statistical significance was p=0.01|ANOVA||Treatment difference=Visit5-Baseline|||1.98|0.64|<0.0001
72363530|NCT03829228|144238231|SUPERIORITY||||||<|0.0001||||||The threshold for statistical significant was p=0.01.|Regression, Logistic|||||||<0.0001
72363531|NCT01887327|144238239|OTHER||LS Mean Difference vs Placebo|-31.64|||=|2.1e-06|TWO_SIDED|95.0|-44.0|-19.283|||LS Mean Difference vs Placebo|||||-19.283|-44.000|=0.0000021
72363532|NCT01887327|144238239|OTHER||LS Mean Difference vs Placebo|-27.4|||=|2.6e-05|TWO_SIDED|95.0|-39.657|-15.142|||LS Mean Difference vs Placebo|||||-15.142|-39.657|=0.0000260
72363533|NCT03027609|144238243|SUPERIORITY|comparison between the treatment and placebo|Risk Difference (RD)|-5.54||||0.6154|TWO_SIDED|95.0|-21.9|10.8||P-value was obtained with the stratified CMH test adjusted for baseline randomization strata|Cochran-Mantel-Haenszel|||||10.8|-21.9|0.6154
72363534|NCT03027609|144238244|SUPERIORITY||Risk Difference (RD)|4.01||||0.8426|TWO_SIDED|95.0|-18.5|10.5||P-value was obtained with the stratified CMH test adjusted for baseline randomization strata|Cochran-Mantel-Haenszel|||Comparison between the treatment and placebo||10.5|-18.5|0.8426
72363535|NCT03027609|144238245|SUPERIORITY|comparison between the treatment and placebo|P value CMH|3.6||||0.3562|TWO_SIDED|95.0|-13.1|20.3||P-value was obtained with the stratified CMH test adjusted for baseline randomization strata|Cochran-Mantel-Haenszel|||Comparison between the treatment and placebo||20.3|-13.1|0.3562
72363536|NCT03027609|144238246|SUPERIORITY|Comparison between the treatment and placebo|P value CMH|-2.81||||0.8472|TWO_SIDED|95.0|-18.9|13.2||P-value was obtained with the stratified CMH test adjusted for baseline randomization strata|Cochran-Mantel-Haenszel|||||13.2|-18.9|0.8472
72363537|NCT03027609|144238247|SUPERIORITY||Mean Difference (Final Values)|22.3||||0.4616|TWO_SIDED|95.0|-16.2|60.6||Marginally statistically significant only if p\<0.1|Chi-squared|||Data for Day 14||60.6|-16.2|0.4616
72363538|NCT03027609|144238247|SUPERIORITY||Mean Difference (Final Values)|22.3||||0.4053|TWO_SIDED|95.0|-13.3|57.8||Data for Day 21|Chi-squared|||Data for Day 21||57.8|-13.3|0.4053
72363539|NCT03027609|144238248|SUPERIORITY||Mean Difference (Final Values)|38.1||||0.0833|TWO_SIDED|90.0|-14.8|90.9||Marginally statistically significant only if p\<0.1|Chi-squared|||Data for Day 14||90.9|-14.8|0.0833
72363540|NCT03027609|144238248|SUPERIORITY||Mean Difference (Net)|23.8||||0.5151|TWO_SIDED|90.0|-30.5|78.1||Data for Day 21|Chi-squared|Marginally statistically significant only if p\<0.1 Day 21||Data for Day 21||78.1|-30.5|0.5151
72363541|NCT01462370|144238253|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The noninferiority margin is -3.7 units.|Difference in LS Means|0.89||||0.043|TWO_SIDED|95.0|0.03|1.76||A priori threshold for statistical significance = \<0.025 (one-sided).|ANOVA|Adjusted for treatment, period, sequence, patient (sequence), and baseline pain intensity (moderate or severe).||With at least 128 participants, the study had a 92% power to establish that etoricoxib is noninferior to ibuprofen (null hypothesis). The power and sample size were based on the following assumptions: 1) an approximately 15% protocol violation rate, 2) a noninferiority margin of -3.7 units (etoricoxib minus ibuprofen), and 3) an intrapatient standard deviation of 8 units.||1.76|0.03|0.043
72363542|NCT01462370|144238254|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|0.2||||0.768|TWO_SIDED|95.0|-1.16|1.57||A nominal threshold for statistical significance = \<0.05.|ANOVA|Adjusted for treatment, period, sequence, patient (sequence), and baseline pain intensity (moderate or severe).||||1.57|-1.16|0.768
72363543|NCT01462370|144238255|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|0.26||||0.007|TWO_SIDED|95.0|0.07|0.45||A nominal threshold for statistical significance = \<0.05.|ANOVA|Adjusted for treatment, period, sequence, patient (sequence), and baseline pain intensity (moderate or severe).||||0.45|0.07|0.007
72363544|NCT01462370|144238256|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|0.36|||<|0.001|TWO_SIDED|95.0|0.17|0.54||A nominal threshold for statistical significance = \<0.05.|ANOVA|Adjusted for treatment, period, sequence, patient (sequence), and baseline pain intensity (moderate or severe).||||0.54|0.17|<0.001
72368750|NCT02289157|144247210|OTHER|||||||0.44|||||||Wilcoxon (Mann-Whitney)|||Ho: There is no difference in the number of patients with Incision and Drainage and/or Extirpation between the study (icNPT) and comparison groups.||||0.44
72368751|NCT02289157|144247211|OTHER|Cochran-Mantel-Haenzel test for interactions between different risk factors: scheduled vs unscheduled cesarean section and icNPT vs Standard dressing||||||0.68||||||Ho: There is no difference between patients with wound morbidity that is significantly affected by the use of icNPT and whether or not the cesarean is scheduled or unscheduled.|Cochran-Mantel-Haenszel|||||||0.68
72368752|NCT02289157|144247212|OTHER|Cochran-Mantel-Haenzel test for interactions between different risk factors: pfannenstiel vs midline abdominal incision and icNPT vs Standard dressing||||||0.27|||||||Cochran-Mantel-Haenszel|||||||0.27
72429961|NCT01815736|144371074|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Null hypothesis: The E/C/F/TAF group was at least 12% worse than the Stay on Baseline Regimen group; alternative hypothesis: the E/C/F/TAF group was less than 12% worse than the in Stay on Baseline Regimen group.|Difference in percentages|3.7||||0.017|TWO_SIDED|95.0|0.4|7.0||P-value for the superiority test comparing the percentages of virologic success was from the CMH test stratified by the prior treatment regimen (STB, ATR, ATV/boosted+TVD).|Cochran-Mantel-Haenszel||The difference in percentages of virologic success and its 95% CI were calculated based on the MH proportion adjusted by the prior treatment regimen.|||7.0|0.4|0.017
72429962|NCT01815736|144371075|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Null hypothesis: The E/C/F/TAF group was at least 12% worse than the Stay on Baseline Regimen group; alternative hypothesis: the E/C/F/TAF group was less than 12% worse than the in Stay on Baseline Regimen group.|Difference in percentages|1.8||||0.29|TWO_SIDED|95.0|-1.7|5.3||P-value for the superiority test comparing the percentages of virologic success was from the CMH test stratified by the prior treatment regimen (STB, ATR, ATV/boosted+TVD).|Cochran-Mantel-Haenszel||Difference in percentages of virologic success and its 95% CI were calculated based on the MH proportion adjusted by the prior treatment regimen.|NDA Data Cut||5.3|-1.7|0.29
72429963|NCT01815736|144371075|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Null hypothesis: the E/C/F/TAF group was at least 12% worse than the Stay on Baseline Regimen group; alternative hypothesis: the E/C/F/TAF group was less than 12% worse than the in Stay on Baseline Regimen group.|Difference in percentages|3.2||||0.031|TWO_SIDED|95.0|0.1|6.3||P-value for the superiority test comparing the percentages of virologic success was from the CMH test stratified by the prior treatment regimen (STB, ATR, ATV/boosted+TVD).|Cochran-Mantel-Haenszel||Difference in percentages of virologic success and its 95% CI were calculated based on the MH proportion adjusted by the prior treatment regimen.|All Participants||6.3|0.1|0.031
72429964|NCT01815736|144371076|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Null hypothesis: the E/C/F/TAF group was at least 12% worse than the Stay on Baseline Regimen group; alternative hypothesis: the E/C/F/TAF group was less than 12% worse than the in Stay on Baseline Regimen group.|Difference in percentages|5.3||||0.003|TWO_SIDED|95.0|1.6|9.0||P-value for the superiority test comparing the percentages of virologic success was from the CMH test stratified by the prior treatment regimen (STB, ATR, ATV/boosted+TVD).|Cochran-Mantel-Haenszel||Difference in percentages of virologic success and its 95% CI were calculated based on the MH proportion adjusted by the prior treatment regimen.|||9.0|1.6|0.003
72429965|NCT01815736|144371077|SUPERIORITY||Difference in least squares means|6.0||||0.56|TWO_SIDED|95.0|-14.0|26.0||P-values were from the analysis of variance (ANOVA) model including treatment (E/C/F/TAF vs. SBR) and prior treatment regimen (STB, ATR, ATV/boosted+TVD) as fixed effects.|ANOVA||Difference in least squares means (Diff in LSM), and its 95% CI were from the analysis of variance (ANOVA) model including treatment (E/C/F/TAF vs. FTC/TDF+3rd Agent) and prior treatment regimen (STB, ATR, ATV/boosted+TVD) as fixed effects.|NDA Data Cut: Change at Week 48||26|-14|0.56
72429966|NCT01815736|144371077|SUPERIORITY||Difference in least squares means|11.0||||0.26|TWO_SIDED|95.0|-8.0|29.0||P-values were from the analysis of variance (ANOVA) model including treatment (E/C/F/TAF vs. SBR) and prior treatment regimen (STB, ATR, ATV/boosted+TVD) as fixed effects.|ANOVA||Difference in least squares means and its 95% CI were from the analysis of variance (ANOVA) model including treatment (E/C/F/TAF vs.SBR) and prior treatment regimen (STB, ATR, ATV/boosted+TVD) as fixed effects.|All Participants: Change at Week 48||29|-8|0.26
72429967|NCT01815736|144371078|SUPERIORITY||Difference in least squares means|18.0||||0.074|TWO_SIDED|95.0|-2.0|38.0||P-values were from the analysis of variance (ANOVA) model including treatment (E/C/F/TAF vs. SBR) and prior treatment regimen (STB, ATR, ATV/boosted+TVD) as fixed effects.|ANOVA||Difference in least squares means and its 95% CI were from the analysis of variance (ANOVA) model including treatment (E/C/F/TAF vs. SBR) and prior treatment regimen (STB, ATR, ATV/boosted+TVD) as fixed effects.|||38|-2|0.074
72429968|NCT00550173|144371088|SUPERIORITY_OR_OTHER|||||||0.003||||||If global test across 3 arms is significant at a 2-sided 0.2 level, then conduct 2-sided pairwise tests between combination and each single agent under the global model. Significance is claimed only if both the global and pairwise tests p\<0.05.|Regression, Cox|Model is adjusted to covariates ECOG PS (0/1 vs.2), histological subtype (adeno vs. non-adeno), race (East Asian and non-East Asian) and gender.||Overall; Global null hypothesis was rejected at 2-sided 0.2 significance level.||||0.003
72429969|NCT00550173|144371088|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.57||||0.002|TWO_SIDED|95.0|0.4|0.81||If global test across 3 arms is significant at a 2-sided 0.2 level, then conduct 2-sided pairwise tests between combination and each single agent under the global model. Significance is claimed only if both the global and pairwise tests p\<0.05.|Regression, Cox|Model is adjusted to covariates ECOG PS (0/1 vs.2), histological subtype (adeno vs. non-adeno), race (East Asian and non-East Asian) and gender.||Primary Analysis; Global null hypothesis was rejected at 2-sided 0.2 significance level.||0.81|0.40|0.002
72429970|NCT00550173|144371088|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.58||||0.005|TWO_SIDED|95.0|0.39|0.85||If global test across 3 arms is significant at a 2-sided 0.2 level, then conduct 2-sided pairwise tests between combination and each single agent under the global model. Significance is claimed only if both the global and pairwise tests p\<0.05.|Regression, Cox|Model is adjusted to covariates ECOG PS (0/1 vs.2), histological subtype (adeno vs. non-adeno), race (East Asian and non-East Asian) and gender.||Primary Analysis; Global null hypothesis was rejected at 2-sided 0.2 significance level.||0.85|0.39|0.005
72429971|NCT00550173|144371088|SUPERIORITY_OR_OTHER||Hazard Ratio, log|0.99||||0.959|TWO_SIDED|95.0|0.7|1.4||If global test across 3 arms is significant at a 2-sided 0.2 level, then conduct 2-sided pairwise tests between combination and each single agent under the global model. Significance is claimed only if both the global and pairwise tests p\<0.05.|Regression, Cox|Model is adjusted to covariates ECOG PS (0/1 vs.2), histological subtype (adeno vs. non-adeno), race (East Asian and non-East Asian) and gender.||Secondary Analysis; Global null hypothesis was rejected at 2-sided 0.2 significance level.||1.40|0.70|0.959
72429972|NCT00550173|144371089|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Regression, Logistic|Model is adjusted to covariates ECOG PS (0/1 vs.2), histological subtype (adeno vs. non-adeno), race (East Asian and non-East Asian) and gender.||||||<0.001
72429973|NCT00550173|144371089|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.09||||0.031|TWO_SIDED|95.0|1.07|4.09|||Regression, Logistic|Model is adjusted to covariates ECOG PS (0/1 vs.2), histological subtype (adeno vs. non-adeno), race (East Asian and non-East Asian) and gender.||||4.09|1.07|0.031
72429974|NCT00550173|144371089|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|7.68|||<|0.001|TWO_SIDED|95.0|3.19|18.48|||Regression, Logistic|Model is adjusted to covariates ECOG PS (0/1 vs.2), histological subtype (adeno vs. non-adeno), race (East Asian and non-East Asian) and gender.||||18.48|3.19|<0.001
72429975|NCT00550173|144371089|SUPERIORITY_OR_OTHER||Odds Ratio, log|0.27||||0.004|TWO_SIDED|95.0|0.11|0.66|||Regression, Logistic|Model is adjusted to covariates ECOG PS (0/1 vs.2), histological subtype (adeno vs. non-adeno), race (East Asian and non-East Asian) and gender.||||0.66|0.11|0.004
72429976|NCT00550173|144371090|SUPERIORITY_OR_OTHER|||||||0.194|||||||Regression, Cox|Model is adjusted to covariates ECOG PS (0/1 vs.2), histological subtype (adeno vs. non-adeno), race (East Asian and non-East Asian) and gender.||||||0.194
72429977|NCT00550173|144371090|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.08||||0.747|TWO_SIDED|95.0|0.69|1.67|||Regression, Cox|Model is adjusted to covariates ECOG PS (0/1 vs.2), histological subtype (adeno vs. non-adeno), race (East Asian and non-East Asian) and gender.||||1.67|0.69|0.747
72429978|NCT00550173|144371090|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.75||||0.168|TWO_SIDED|95.0|0.49|1.13|||Regression, Cox|Model is adjusted to covariates ECOG PS (0/1 vs.2), histological subtype (adeno vs. non-adeno), race (East Asian and non-East Asian) and gender.||||1.13|0.49|0.168
72429979|NCT00550173|144371090|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.44||||0.094|TWO_SIDED|95.0|0.94|2.21|||Regression, Cox|Model is adjusted to covariates ECOG PS (0/1 vs.2), histological subtype (adeno vs. non-adeno), race (East Asian and non-East Asian) and gender.||||2.21|0.94|0.094
72429980|NCT00550173|144371092|SUPERIORITY_OR_OTHER|||||||0.306|||||||Regression, Logistic|Model is adjusted to covariates ECOG PS (0/1 vs.2), histological subtype (adeno vs. non-adeno), race (East Asian and non-East Asian) and gender.||||||0.306
72429981|NCT00550173|144371092|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.66||||0.127|TWO_SIDED|95.0|0.87|3.18|||Regression, Logistic|Model is adjusted to covariates ECOG PS (0/1 vs.2), histological subtype (adeno vs. non-adeno), race (East Asian and non-East Asian) and gender.||||3.18|0.87|0.127
72429982|NCT00550173|144371092|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.4||||0.318|TWO_SIDED|95.0|0.72|2.71|||Regression, Logistic|Model is adjusted to covariates ECOG PS (0/1 vs.2), histological subtype (adeno vs. non-adeno), race (East Asian and non-East Asian) and gender.||||2.71|0.72|0.318
72429983|NCT00550173|144371092|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.18||||0.599|TWO_SIDED|95.0|0.63|2.22|||Regression, Logistic|Model is adjusted to covariates ECOG PS (0/1 vs.2), histological subtype (adeno vs. non-adeno), race (East Asian and non-East Asian) and gender.||||2.22|0.63|0.599
72429984|NCT00550173|144371093|SUPERIORITY_OR_OTHER|||||||0.013||95.0|||||Regression, Cox|Model is adjusted to covariates ECOG PS (0/1 vs.2), histological subtype (adeno vs. non-adeno), race (East Asian and non-East Asian) and gender.||||||0.013
72429985|NCT00550173|144371093|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.59||||0.007|TWO_SIDED|95.0|0.41|0.87||Model is adjusted to covariates ECOG PS (0/1 vs.2), histological subtype (adeno vs. non-adeno), race (East Asian and non-East Asian) and gender.|Regression, Cox|Model is adjusted to covariates ECOG PS (0/1 vs.2), histological subtype (adeno vs. non-adeno), race (East Asian and non-East Asian) and gender.||||0.87|0.41|0.007
72429986|NCT00550173|144371093|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.92||||0.7|TWO_SIDED|95.0|0.62|1.38|||Regression, Cox|Model is adjusted to covariates ECOG PS (0/1 vs.2), histological subtype (adeno vs. non-adeno), race (East Asian and non-East Asian) and gender.||||1.38|0.62|0.700
72429987|NCT00550173|144371093|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.64||||0.023|TWO_SIDED|95.0|0.44|0.94|||Regression, Cox|Model is adjusted to covariates ECOG PS (0/1 vs.2), histological subtype (adeno vs. non-adeno), race (East Asian and non-East Asian) and gender.||||0.94|0.44|0.023
72429988|NCT00550173|144371094|SUPERIORITY_OR_OTHER|||||||0.04||95.0|||||Regression, Cox|||||||0.040
72429989|NCT00550173|144371094|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.62||||0.241|TWO_SIDED|95.0|0.27|1.38|||Regression, Cox|||||1.38|0.27|0.241
72429990|NCT00550173|144371094|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.32||||0.011|TWO_SIDED|95.0|0.14|0.78|||Regression, Cox|||||0.78|0.14|0.011
72429991|NCT00550173|144371094|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.9||||0.128|TWO_SIDED|95.0|0.83|4.36|||Regression, Cox|||||4.36|0.83|0.128
72429992|NCT02325713|144371106|SUPERIORITY_OR_OTHER||Geometric Least square (LS) mean ratio|96.2|||||TWO_SIDED|90.0|83.7|110.6||||||||110.6|83.7|
72429993|NCT02325713|144371106|SUPERIORITY_OR_OTHER||Geometric LS mean ration|18.4|||||TWO_SIDED|90.0|15.3|22.0||||||||22.0|15.3|
72429994|NCT02325713|144371106|SUPERIORITY_OR_OTHER||Geometric LS mean ration|222.7|||||TWO_SIDED|90.0|186.8|265.6||||||||265.6|186.8|
72429995|NCT02325713|144371106|SUPERIORITY_OR_OTHER||Geometric LS mean ration|238.1|||||TWO_SIDED|90.0|198.7|285.3||||||||285.3|198.7|
72429996|NCT02325713|144371106|SUPERIORITY_OR_OTHER||Geometric LS mean ration|82.1|||||TWO_SIDED|90.0|68.5|98.3||||||||98.3|68.5|
72429997|NCT03639675|144371152|OTHER||Mean change|-8.3||||0.0004|TWO_SIDED|95.0|-12.2|-4.4|||one-sample t-statistics|||||-4.4|-12.2|0.0004
72429998|NCT02118714|144371161|OTHER||Percentage of Participants|23.5|||||TWO_SIDED|80.0|10.7|41.6||||||||41.6|10.7|
72429999|NCT02118714|144371161|OTHER||Percentage of Participants|23.5|||||TWO_SIDED|95.0|6.8|49.9||||||||49.9|6.8|
72430000|NCT02118714|144371162|OTHER||Percentage of Participants|11.8|||||TWO_SIDED|80.0|3.2|28.4||||||||28.4|3.2|
72430001|NCT02118714|144371162|OTHER||Percentage of Participants|11.8|||||TWO_SIDED|95.0|1.5|36.4||||||||36.4|1.5|
72430002|NCT01152554|144371181|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.9|STANDARD_ERROR_OF_MEAN|0.24||0.697|TWO_SIDED|95.0|0.54|1.5|||Regression, Logistic||TC-5214 is the numerator in the OR, OR\>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization MADRS total score as a covariate.||1.50|0.54|0.697
72430003|NCT01152554|144371182|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.84|STANDARD_ERROR_OF_MEAN|0.27||0.582|TWO_SIDED|95.0|0.45|1.57|||Regression, Logistic||TC-5214 is the numerator in the OR, OR\>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization MADRS total score as a covariate.||1.57|0.45|0.582
72430004|NCT03785340|144371219|SUPERIORITY|"The endpoints were tested in a fixed sequence, proceeding to the next endpoint until a p-value \>0.05 was found:~1. Change from baseline to 4 weeks (Day 28) in SANDE score~2. Change from baseline to 4 weeks (Day 28) in Lissamine Green conjunctival staining scores~3. Change from baseline to 2 weeks (Day 14) in SANDE score~4. Change from baseline to 2 weeks (Day 14) in Lissamine Green conjunctival staining scores"|Least squares mean difference|-0.844||||0.739|TWO_SIDED|95.0|-5.823|4.134|||Mixed Model Repeated Measures Analysis||Change from baseline to 4 weeks (Day 28) in SANDE score; OCU-310 vs. Placebo|Four endpoints (two primary and two secondary) were to be tested in a fixed sequence, proceeding to the next endpoint until a p-value \>0.05 was found. The analysis of the four outcomes employed a repeated measures mixed model with mean change from baseline score at the stated time point as the response with baseline score as a covariate and treatment, visit, and their interaction as fixed effects. The least squares mean difference (OCU 310 - placebo) at the stated time point was tested.||4.134|-5.823|0.739
72430005|NCT02923895|144371223|SUPERIORITY|All statistical analyses were conducted under the null hypothesis (H0) of no difference between treatments versus the alternate hypothesis (H1) of a difference between treatments.|Mean Difference (Net)|-1.31|||<|0.0001|TWO_SIDED|95.0|-1.5|-1.128||From ANCOVA model with change from baseline in Schiff Sensitivity Score as response and treatment as a factor and baseline Schiff sensitivity score as a covariate.|ANCOVA||Difference is first named dentifrice minus second named dentifrice such that a negative difference favours first named dentifrice.|||-1.128|-1.500|<.0001
72430006|NCT04320615|144371235|OTHER||Median Difference (Final Values)|-1.0||||0.36|TWO_SIDED|95.0|-2.5|0.0|||Van Elteren Test|||||0.0|-2.5|0.3600
72430007|NCT04320615|144371236|OTHER||Hazard Ratio (HR)|1.448||||0.0443|TWO_SIDED|95.0|1.01|2.08|||Log Rank|||||2.08|1.01|0.0443
72430008|NCT04320615|144371237|OTHER||Hazard Ratio (HR)|1.263||||0.082|TWO_SIDED|95.0|0.97|1.64|||Log Rank|||||1.64|0.97|0.0820
72430009|NCT04320615|144371238|OTHER||Hazard Ratio (HR)|1.35||||0.037|TWO_SIDED|95.0|1.02|1.79|||Log Rank|||||1.79|1.02|0.0370
72430010|NCT04320615|144371239|OTHER||Weighted % difference|-6.2||||0.0996|TWO_SIDED|95.0|-13.8|1.4|||Cochran-Mantel-Haenszel|||||1.4|-13.8|0.0996
72430011|NCT04320615|144371239|OTHER||Weighted % difference|-8.9||||0.1355|TWO_SIDED|95.0|-20.7|3.0|||Cochran-Mantel-Haenszel|||||3.0|-20.7|0.1355
72430012|NCT04320615|144371240|OTHER||Median Difference (Final Values)|5.5||||0.3202|TWO_SIDED|95.0|-2.8|13.0|||Van Elteren test|||||13.0|-2.8|0.3202
72430013|NCT04320615|144371241|OTHER||Weighted % difference|-5.7||||0.1514|TWO_SIDED|95.0|-13.7|2.2|||Cochran-Mantel-Haenszel|||||2.2|-13.7|0.1514
72430014|NCT04320615|144371241|OTHER||Weighted % difference|-14.8||||0.029|TWO_SIDED|95.0|-28.6|-1.0|||Cochran-Mantel-Haenszel|||||-1.0|-28.6|0.0290
72430015|NCT04320615|144371242|OTHER||Median Difference (Final Values)|-5.8||||0.0454|TWO_SIDED|95.0|-15.0|2.9|||Van Elteren test|||||2.9|-15.0|0.0454
72430016|NCT04320615|144371243|OTHER||Median Difference (Final Values)|-1.0||||0.0548|TWO_SIDED|95.0|-2.0|0.5|||Van Elteren test|||||0.5|-2.0|0.0548
72430017|NCT04320615|144371244|OTHER||Hazard Ratio (HR)|0.79||||0.1627|TWO_SIDED|95.0|0.57|1.1|||Log Rank|||||1.10|0.57|0.1627
72430018|NCT04320615|144371245|OTHER||Weighted % difference|0.3||||0.941|TWO_SIDED|95.0|-7.6|8.2|||Cochran-Mantel-Haenszel|||||8.2|-7.6|0.9410
72430019|NCT04320615|144371246|OTHER||Hazard Ratio (HR)|1.307||||0.0528|TWO_SIDED|95.0|1.0|1.72|||Log Rank|||||1.72|1.00|0.0528
72430020|NCT04320615|144371247|OTHER||Median Difference (Final Values)|-1.5||||0.0477|TWO_SIDED|95.0|-9.0|0.5|||Van Elteren test|||||0.5|-9.0|0.0477
72430021|NCT01449721|144371248|SUPERIORITY_OR_OTHER|||||||0.064|||||||2-sample z-test|z-test for differences in proportions||Null hypothesis: In patients with moderate severity sepsis, there is no change in the incidence of organ dysfunction within 72 hours associated with the use of an empiric fluid resuscitation algorithm.||||0.064
72430022|NCT02107443|144371276|SUPERIORITY||Mean Difference (Final Values)|3.59|||<|0.0001|TWO_SIDED|95.0|||||Mixed Models Analysis|||||||<0.0001
72430023|NCT02107443|144371277|SUPERIORITY||Mean Difference (Final Values)|1.09||||0.041|TWO_SIDED|95.0|||||Mixed Models Analysis|||||||0.041
72430024|NCT02107443|144371279|SUPERIORITY||Mean Difference (Final Values)|1.05||||0.03|TWO_SIDED|95.0|0.12|1.98|||Mixed Models Analysis|The above p-values is for 4-6 weeks.|The above values are for 4-6 weeks.|||1.98|0.12|0.03
72430025|NCT02107443|144371279|SUPERIORITY||Mean Difference (Final Values)|0.83||||0.08|TWO_SIDED|95.0|-0.11|1.77|||Mixed Models Analysis|The above p-value is for is for 3 months.|The above values are for 3 months|||1.77|-0.11|.08
72430026|NCT02107443|144371279|SUPERIORITY||Mean Difference (Final Values)|0.62||||0.2|TWO_SIDED|95.0|-0.36|1.59|||Mixed Models Analysis|The above p-value is for 6 months|The above values are for 6 months.|||1.59|-0.36|0.20
72430027|NCT03786094|144371308|SUPERIORITY||Hazard Ratio (HR)|1.1||||0.445|TWO_SIDED|96.0|0.85|1.41|||t-test, 2 sided||HR and associated 2-sided 96% CI are estimated by a Cox proportional hazards model stratified for randomization stratification factors including a fixed effect term for treatment arm.|||1.41|0.85|0.4450
72430028|NCT03786094|144371309|SUPERIORITY||Hazard Ratio (HR)|1.07||||0.6158|TWO_SIDED|96.0|0.81|1.41|||t-test, 2 sided||HR and associated 2-sided 96% CI are estimated by a Cox proportional hazards model stratified for randomization stratification factors including a fixed effect term for treatment arm.|||1.41|0.81|0.6158
72430029|NCT03786094|144371310|SUPERIORITY||Hazard Ratio (HR)|1.08||||0.6126|TWO_SIDED|99.9|0.66|1.77|||t-test, 2 sided|||||1.77|0.66|0.6126
72430030|NCT02711826|144371317|SUPERIORITY|||||||0.425|||||||Fisher Exact|||||||0.425
72430031|NCT02711826|144371318|SUPERIORITY|||||||0.7|||||||Kruskal-Wallis|||||||0.700
72430032|NCT02711826|144371319|SUPERIORITY|||||||0.201|||||||Kruskal-Wallis|||||||0.201
72430033|NCT01706965|144371380|SUPERIORITY|||||||0.38|||||||ANOVA|||Univariate ANOVA, controlling for baseline PANSS total||||.38
72430034|NCT01706965|144371381|SUPERIORITY|ANOVA, controlled for baseline MATRICS||||||0.99|||||||ANOVA|||||||.99
72430035|NCT01563978|144371382|SUPERIORITY_OR_OTHER||Least squares mean treatment difference|2.93||||0.023|TWO_SIDED|95.0|0.4|5.45|||ANCOVA|Inc. baseline (covariate); treatment, region, prior failure to biologic disease modifying antirheumatic drug \& baseline antihypertensive use (factors)||||5.45|0.40|0.023
72430036|NCT01563978|144371383|SUPERIORITY_OR_OTHER||Least squares mean treatment difference|3.53|||<|0.001|TWO_SIDED|95.0|2.04|5.03|||ANCOVA|Inc. baseline (covariate); treatment, region, prior failure to biologic disease modifying antirheumatic drug \& baseline antihypertensive use (factors)||||5.03|2.04|<0.001
72430037|NCT01563978|144371384|SUPERIORITY_OR_OTHER||Least square means treatment difference|3.3||||0.02|TWO_SIDED|95.0|0.53|6.08|||ANCOVA|Inc. baseline (covariate); treatment, region, prior failure to biologic disease modifying antirheumatic drug \& baseline antihypertensive use (factors)||Change from baseline in mean daytime SBP (Day 28)||6.08|0.53|0.020
72430038|NCT01563978|144371384|SUPERIORITY_OR_OTHER||Least square means treatment difference|3.75|||<|0.001|TWO_SIDED|95.0|2.08|5.42|||ANCOVA|Inc. baseline (covariate); treatment, region, prior failure to biologic disease modifying antirheumatic drug \& baseline antihypertensive use (factors)||Change from baseline in mean daytime DBP (Day 28)||5.42|2.08|<0.001
72430039|NCT01563978|144371384|SUPERIORITY_OR_OTHER||Least square means treatment difference|2.07||||0.179|TWO_SIDED|95.0|-0.96|5.11|||ANCOVA|Inc. baseline (covariate); treatment, region, prior failure to biologic disease modifying antirheumatic drug \& baseline antihypertensive use (factors)||Change from baseline in mean night-time SBP (Day 28)||5.11|-0.96|0.179
72430040|NCT01563978|144371384|SUPERIORITY_OR_OTHER||Least square means treatment difference|3.14||||0.002|TWO_SIDED|95.0|1.13|5.14|||ANCOVA|Inc. baseline (covariate); treatment, region, prior failure to biologic disease modifying antirheumatic drug \& baseline antihypertensive use (factors)||Change from baseline in mean night-time DBP (Day 28)||5.14|1.13|0.002
72430041|NCT01563978|144371385|SUPERIORITY_OR_OTHER||Least square means treatment difference|3.11||||0.024|TWO_SIDED|95.0|0.41|5.81|||ANCOVA|Inc. baseline (covariate); treatment, region, prior failure to biologic disease modifying antirheumatic drug \& baseline antihypertensive use (factors)||Change from baseline in mean awake SBP (Day 28)||5.81|0.41|0.024
72430042|NCT01563978|144371385|SUPERIORITY_OR_OTHER||Least square means treatment difference|3.66|||<|0.001|TWO_SIDED|95.0|2.1|5.22|||ANCOVA|Inc. baseline (covariate); treatment, region, prior failure to biologic disease modifying antirheumatic drug \& baseline antihypertensive use (factors)||Change from baseline in mean awake DBP (Day 28)||5.22|2.10|<0.001
72430043|NCT01563978|144371386|SUPERIORITY_OR_OTHER||Least squares mean treatment difference|1.99||||0.223|TWO_SIDED|95.0|-1.22|5.2|||ANCOVA|Inc. baseline (covariate); treatment, region, prior failure to biologic disease modifying antirheumatic drug \& baseline antihypertensive use (factors)||Change from baseline in mean sleeping SBP||5.20|-1.22|0.223
72430044|NCT01563978|144371386|SUPERIORITY_OR_OTHER||Least square means treatment difference|2.87||||0.007|TWO_SIDED|95.0|0.81|4.93|||ANCOVA|Inc. baseline (covariate); treatment, region, prior failure to biologic disease modifying antirheumatic drug \& baseline antihypertensive use (factors)||Change from baseline in mean sleeping DBP||4.93|0.81|0.007
72430045|NCT01563978|144371387|SUPERIORITY_OR_OTHER||Least square means treatment difference|2.24||||0.2|TWO_SIDED|95.0|-1.2|5.69|||ANCOVA|Inc. baseline (covariate); treatment, region, prior failure to biologic disease modifying antirheumatic drug \& baseline antihypertensive use (factors)||Change from baseline in clinic SBP (Day 29)||5.69|-1.20|0.200
72430046|NCT01563978|144371387|SUPERIORITY_OR_OTHER||Least square means treatment difference|2.36||||0.046|TWO_SIDED|95.0|0.05|4.68|||ANCOVA|Inc. baseline (covariate); treatment, region, prior failure to biologic disease modifying antirheumatic drug \& baseline antihypertensive use (factors)||Change from baseline in clinic DBP (Day 29)||4.68|0.05|0.046
72430047|NCT01563978|144371388|SUPERIORITY_OR_OTHER||Least square means treatment difference|6.31|||<|0.001|TWO_SIDED|95.0|3.6|9.03|||ANCOVA|Inc. baseline (covariate); treatment, region, prior failure to biologic disease modifying antirheumatic drug \& baseline antihypertensive use (factors)||Change from baseline in weekly average pre-dose home SBP (Week 4)||9.03|3.60|<0.001
72430048|NCT01563978|144371388|SUPERIORITY_OR_OTHER||Least square means treatment difference|4.58|||<|0.001|TWO_SIDED|95.0|2.91|6.25|||ANCOVA|Inc. baseline (covariate); treatment, region, prior failure to biologic disease modifying antirheumatic drug \& baseline antihypertensive use (factors)||Change from baseline in weekly average pre-dose home DBP (Week 4)||6.25|2.91|<0.001
72430049|NCT01563978|144371389|SUPERIORITY_OR_OTHER||Least square means treatment difference|7.22|||<|0.001|TWO_SIDED|95.0|4.29|10.16|||ANCOVA|Inc. baseline (covariate); treatment, region, prior failure to biologic disease modifying antirheumatic drug \& baseline antihypertensive use (factors)||Change from baseline in weekly average post-dose home SBP (Week 4)||10.16|4.29|<0.001
72363545|NCT01462370|144238257|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.89||||0.371|TWO_SIDED|95.0|0.7|1.14||A priori threshold for statistical significance = \<0.05.|Regression, Cox|Adjusted for treatment, period, and baseline pain intensity.||||1.14|0.70|0.371
72368753|NCT02289157|144247213|OTHER|Cochran-Mantel-Haenzel test for interactions between different risk factors: ruptured vs unruptured membranes and icNPT vs Standard dressing||||||0.55|||||||Cochran-Mantel-Haenszel|||||||0.55
72368754|NCT02289157|144247214|OTHER|Cochran-Mantel-Haenzel test for interactions between labor vs no labor stratified by icNPT vs Standard dressing||||||0.49|||||||Cochran-Mantel-Haenszel|||||||0.49
72368755|NCT02289157|144247215|OTHER|Cochran-Mantel-Haenzel measure used to estimate interaction between patients with hypertension versus no hypertension stratified by icNPT versus standard dressing in wound morbidity||||||0.92|||||||Cochran-Mantel-Haenszel|||||||0.92
72368756|NCT02289157|144247216|OTHER|Cochran-Mantel-Haenzel measure used to estimate interaction in icNPT and Standard wound dressings stratified by women with insulin requiring diabetes and no insulin requiring Diabetes.||||||0.22|||||||Cochran-Mantel-Haenszel|||||||0.22
72368757|NCT02289157|144247217|OTHER|Cochran-Mantel-Haenzel measure used to estimate interaction between chorioamnionitis and no chorioamnionitis stratified by icNPT and standard dressing, for wound morbidity||||||0.74|||||||Cochran-Mantel-Haenszel|||||||0.74
72368758|NCT02983552|144247218|SUPERIORITY||Mean Difference (Final Values)|-0.3||||0.71|TWO_SIDED|95.0|-2.2|1.7||a priori threshold for statistical significance: 2-sided type I error rate of 5%|ANOVA|Adjusted for baseline amblyopic-eye visual acuity.|A 2-sided 95% confidence interval was computed on the adjusted treatment group difference evaluating change in amblyopic-eye visual acuity from baseline to the 4 week visit.|A modified intent-to-treat analysis was performed using an ANCOVA model to compare the effectiveness of two treatments (2-sided hypothesis test), adjusting for baseline visual acuity. The primary outcome measure was change in amblyopic-eye VA from baseline to 4 weeks. A 2-sided 95% confidence interval (CI) was computed on the adjusted treatment group difference at 4 weeks. There was no imputation for missing data.||1.7|-2.2|0.71
72368759|NCT02983552|144247220|SUPERIORITY||Mean Difference (Final Values)|-0.1|||||TWO_SIDED|98.3|-2.4|2.1|||||A 2-sided 98.3% confidence interval was computed on the adjusted treatment group difference evaluating change in amblyopic-eye visual acuity from baseline to the 8-week visit.|||2.1|-2.4|
72368760|NCT02983552|144247226|SUPERIORITY||Mean Difference (Final Values)|-2.0|||||TWO_SIDED|98.3|-13.0|9.0||||||Binomial regression was used for the treatment group comparison of the proportion of participants classified as improving 2 or more logMAR lines (10 or more letters if E-ETDRS) from baseline at the 4-week visit, adjusted for visual acuity at randomization.||9|-13|
72368761|NCT02983552|144247227|SUPERIORITY||Mean Difference (Final Values)|-1.0|||||TWO_SIDED|98.3|-15.0|12.0||||||Binomial regression was used for the treatment group comparison of the proportion of participants classified as improving 2 or more logMAR lines (10 or more letters if E-ETDRS) from baseline at the 8-week visit, adjusted for visual acuity at randomization.|For secondary visual acuity outcomes, which included the 8-week treatment group comparison, a Bonferroni adjustment was used to control for multiple testing (3 outcomes tested) to preserve the overall type I error rate at 5% (2-sided alpha=0.017 per test).|12|-15|
72368762|NCT02983552|144247229|SUPERIORITY|||||||0.38||||||The exact Wilcoxon rank-sum test was used to compare the change in stereoacuity levels from baseline to the 4-week visit by treatment group.|Wilcoxon (Mann-Whitney)|||||||0.38
72368763|NCT02983552|144247231|SUPERIORITY|||||||0.53||||||The exact Wilcoxon rank-sum test was used to compare the change in stereoacuity levels from baseline to the 8-week visit by treatment group.|Wilcoxon (Mann-Whitney)|||||||0.53
72368764|NCT02983552|144247233|SUPERIORITY|||||||0.19||||||The exact Wilcoxon rank-sum test was used to compare the change in stereoacuity levels from baseline to the 4-week visit by treatment group for participants without strabismus.|Wilcoxon (Mann-Whitney)|||||||0.19
72368765|NCT02983552|144247235|SUPERIORITY|||||||0.74||||||The exact Wilcoxon rank-sum test was used to compare the change in stereoacuity levels from baseline to the 8-week visit by treatment group for participants without strabismus.|Wilcoxon (Mann-Whitney)|||||||0.74
72368766|NCT02983552|144247240|SUPERIORITY||Mean Difference (Final Values)|-1.1|||||TWO_SIDED|99.0|-2.5|0.4|||||Statistical significance of the treatment group comparison was based on a 2-sided alpha=0.01.|An analysis of covariance (ANCOVA) model was used to compute the treatment group difference in the mean change in fellow-eye visual acuity (letters) from baseline to 4 weeks, adjusting for fellow-eye visual acuity at randomization. A 2-sided 99% confidence interval was computed on the adjusted treatment group difference.||0.4|-2.5|
72368767|NCT02983552|144247241|SUPERIORITY||Mean Difference (Final Values)|-1.0|||||TWO_SIDED|99.0|-2.3|0.3|||||Statistical significance of the treatment group comparison was based on a 2-sided alpha=0.01.|An analysis of covariance (ANCOVA) model was used to compute the treatment group difference in the mean change in fellow-eye visual acuity (letters) from baseline to 8 weeks, adjusting for fellow-eye visual acuity at randomization. A 2-sided 99% confidence interval was computed on the adjusted treatment group difference.||0.3|-2.3|
72368768|NCT02983552|144247242|SUPERIORITY|||||||0.37|||||||Fisher Exact|||Fisher's exact test was used to perform the treatment group comparison of the proportion of participants who developed a new ocular deviation and/or worsening of a pre-existing ocular deviation by 10 prism diopters at the 4-week visit.||||0.37
72368769|NCT02983552|144247243|SUPERIORITY|||||||0.99|||||||Fisher Exact|||Fisher's exact test was used to perform the treatment group comparison of the proportion of participants who developed a new ocular deviation and/or worsening of a pre-existing ocular deviation by 10 prism diopters at the 8-week visit.||||0.99
72368770|NCT02983552|144247244|SUPERIORITY|||||||0.2|||||||Cochran-Armitage trend test|||The frequency of diplopia, across categories of diplopia, was compared between the treatment groups using the Cochran-Armitage trend test.||||0.20
72368771|NCT02983552|144247245|SUPERIORITY||||||>|0.99|||||||Cochran-Armitage trend test|||The frequency of diplopia, across categories of diplopia, was compared between the treatment groups using the Cochran-Armitage trend test.||||>0.99
72368772|NCT02983552|144247246|SUPERIORITY|||||||0.44|||||||Wilcoxon (Mann-Whitney)|||The exact Wilcoxon rank-sum test was used to compare the change in diplopia frequency levels from baseline to the 4-week visit by treatment group.||||0.44
72368773|NCT02983552|144247247|SUPERIORITY||||||>|0.99|||||||Wilcoxon (Mann-Whitney)|||The exact Wilcoxon rank-sum test was used to compare the change in diplopia frequency levels from baseline to the 8-week visit by treatment group.||||>0.99
72368774|NCT02983552|144247248|SUPERIORITY|||||||0.12|||||||Cochran-Armitage trend test|||The frequency of diplopia, across categories of diplopia, was compared between the treatment groups using the Cochran-Armitage trend test.||||0.12
72430050|NCT01563978|144371389|SUPERIORITY_OR_OTHER||Least square means treatment difference|4.74|||<|0.001|TWO_SIDED|95.0|2.9|6.59|||ANCOVA|Inc. baseline (covariate); treatment, region, prior failure to biologic disease modifying antirheumatic drug \& baseline antihypertensive use (factors)||Change from baseline in weekly average post-dose home DBP (Week 4)||6.59|2.90|<0.001
72430051|NCT01563978|144371391|SUPERIORITY_OR_OTHER||Least square means treatment difference|0.74|||<|0.001|TWO_SIDED|95.0|0.4|1.08||Inc. baseline (covariate); treatment, region, prior failure to biologic disease modifying antirheumatic drug \& baseline antihypertensive use (factors)|ANCOVA|||Improvement from baseline at Day 29. Non-responder imputation has been applied following premature withdrawal, or any dose of background disease modifying antirheumatic drug increased or any other RA treatment initiated including DMARDs, anti-TNFs or other biologics, or receiving any parenteral steroids, or for patients with no post baseline data.||1.08|0.40|<0.001
72430052|NCT00729690|144371392|SUPERIORITY_OR_OTHER|||||||0.4742||95.0|||||ANOVA|||For 1st 24 hours NRS AUC Pain scores||||0.4742
72430053|NCT00729690|144371393|SUPERIORITY_OR_OTHER|||||||0.7596||95.0|||||ANOVA|||||||0.7596
72430054|NCT00729690|144371394|SUPERIORITY_OR_OTHER|||||||0.4321||95.0|||||ANOVA|||||||0.4321
72430055|NCT00729690|144371395|SUPERIORITY_OR_OTHER|||||||0.9361||95.0|||||ANOVA|||||||0.9361
72430056|NCT04019561|144371415|SUPERIORITY||Mean Difference (Final Values)|-1.41||||0.439|TWO_SIDED|95.0|-5.02|2.2|||ANCOVA|||||2.20|-5.02|0.439
72430057|NCT04019561|144371415|SUPERIORITY||Mean Difference (Final Values)|-5.01||||0.006|TWO_SIDED|95.0|-8.54|-1.48|||ANCOVA|||||-1.48|-8.54|0.006
72430058|NCT04019561|144371416|SUPERIORITY||Mean Difference (Final Values)|-1.508||||0.695|TWO_SIDED|95.0|-9.191|6.174|||ANCOVA|||||6.174|-9.191|0.695
72430059|NCT04019561|144371416|SUPERIORITY||Mean Difference (Final Values)|-9.291||||0.016|TWO_SIDED|95.0|-16.76|-1.822|||ANCOVA|||||-1.822|-16.760|0.016
72430060|NCT04019561|144371417|SUPERIORITY||Mean Difference (Final Values)|-10.74||||0.468|TWO_SIDED|95.0|-40.174|18.695|||ANCOVA|||||18.695|-40.174|0.468
72430061|NCT04019561|144371417|SUPERIORITY||Mean Difference (Final Values)|-37.395||||0.012|TWO_SIDED|95.0|-66.38|-8.409|||ANCOVA|||||-8.409|-66.380|0.012
72430062|NCT04019561|144371418|SUPERIORITY||Mean Difference (Final Values)|6.26||||0.166|TWO_SIDED|95.0|-2.698|15.218|||ANCOVA|||||15.218|-2.698|0.166
72430063|NCT04019561|144371418|SUPERIORITY||Mean Difference (Final Values)|0.749||||0.856|TWO_SIDED|95.0|-7.537|9.035|||ANCOVA|||||9.035|-7.537|0.856
72430064|NCT04019561|144371419|SUPERIORITY||Mean Difference (Final Values)|-3.283||||0.302|TWO_SIDED|95.0|-9.641|3.076|||ANCOVA|||||3.076|-9.641|0.302
72430065|NCT04019561|144371419|SUPERIORITY||Mean Difference (Final Values)|-2.821||||0.304|TWO_SIDED|95.0|-8.316|2.675|||ANCOVA|||||2.675|-8.316|0.304
72430066|NCT04019561|144371420|SUPERIORITY||Mean Difference (Final Values)|1.038||||0.808|TWO_SIDED|95.0|-7.493|9.569|||ANCOVA|||||9.569|-7.493|0.808
72430067|NCT04019561|144371420|SUPERIORITY||Mean Difference (Final Values)|1.106||||0.786|TWO_SIDED|95.0|-7.043|9.255|||ANCOVA|||||9.255|-7.043|0.786
72430068|NCT04019561|144371421|SUPERIORITY||Mean Difference (Final Values)|3.448||||0.087|TWO_SIDED|95.0|-0.524|7.421|||ANCOVA|||||7.421|-0.524|0.087
72430069|NCT04019561|144371421|SUPERIORITY||Mean Difference (Final Values)|-0.387||||0.834|TWO_SIDED|95.0|-4.085|3.312|||ANCOVA|||||3.312|-4.085|0.834
72430070|NCT04019561|144371422|SUPERIORITY||Mean Difference (Final Values)|-0.386||||0.735|TWO_SIDED|95.0|-2.681|1.908|||ANCOVA|||||1.908|-2.681|0.735
72430071|NCT04019561|144371422|SUPERIORITY||Mean Difference (Final Values)|-1.091||||0.308|TWO_SIDED|95.0|-3.226|1.044|||ANCOVA|||||1.044|-3.226|0.308
72430072|NCT04019561|144371423|SUPERIORITY||Mean Difference (Final Values)|-19.277||||0.195|TWO_SIDED|95.0|-48.704|10.15|||ANCOVA|||||10.150|-48.704|0.195
72430073|NCT04019561|144371423|SUPERIORITY||Mean Difference (Final Values)|-24.328||||0.103|TWO_SIDED|95.0|-53.674|5.019|||ANCOVA|||||5.019|-53.674|0.103
72430074|NCT04019561|144371424|SUPERIORITY||Mean Difference (Final Values)|-10.39||||0.6|TWO_SIDED|95.0|-49.802|29.022|||ANCOVA|||||29.022|-49.802|0.600
72430075|NCT04019561|144371424|SUPERIORITY||Mean Difference (Final Values)|7.086||||0.72|TWO_SIDED|95.0|-32.163|46.336|||ANCOVA|||||46.336|-32.163|0.720
72430076|NCT04019561|144371425|SUPERIORITY||Mean Difference (Final Values)|-9.14||||0.485|TWO_SIDED|95.0|-35.134|16.854|||ANCOVA|||||16.854|-35.134|0.485
72430077|NCT04019561|144371425|SUPERIORITY||Mean Difference (Final Values)|-19.645||||0.131|TWO_SIDED|95.0|-45.288|5.999|||ANCOVA|||||5.999|-45.288|0.131
72430078|NCT04019561|144371426|SUPERIORITY||Mean Difference (Final Values)|-0.719||||0.564|TWO_SIDED|95.0|-3.191|1.754|||ANCOVA|||||1.754|-3.191|0.564
72430079|NCT04019561|144371426|SUPERIORITY||Mean Difference (Final Values)|-2.366||||0.062|TWO_SIDED|95.0|-4.854|0.122|||ANCOVA|||||0.122|-4.854|0.062
72430080|NCT04019561|144371427|SUPERIORITY||Mean Difference (Final Values)|-0.084||||0.856|TWO_SIDED|95.0|-1.007|0.838|||ANCOVA|||||0.838|-1.007|0.856
72430081|NCT04019561|144371427|SUPERIORITY||Mean Difference (Final Values)|-0.777||||0.098|TWO_SIDED|95.0|-1.7|0.147|||ANCOVA|||||0.147|-1.700|0.098
72430082|NCT02320721|144371445|NON_INFERIORITY|Non-inferiority of HOE901-U300 vs Lantus was demonstrated if the upper bound of the two-sided 95% confidence interval (CI) for the difference between groups was \<0.3%.|LS Mean Difference|0.02|STANDARD_ERROR_OF_MEAN|0.056|||TWO_SIDED|95.0|-0.092|0.129||||||Analysis was performed using ANCOVA model including the fixed categorical effects of treatment group, randomization strata, as well as the continuous fixed covariates of baseline value and following multiple imputation procedure for missing data.||0.129|-0.092|
72430083|NCT02320721|144371446|SUPERIORITY_OR_OTHER_LEGACY|A hierarchical testing procedure was used to control type I error and handle multiple endpoint analyses. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only if previous endpoint was statistically significant at 0.05 level.|Relative risk|1.01||||0.8415|TWO_SIDED|95.0|0.89|1.153||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||Analysis was done by Cochran-Mantel-Haenszel method with randomization strata (screening HbA1c \[\<8.0%; ≥8.0%\], previous use of insulin \[naive, pre-treated\], use of sulfonylurea or meglitinides at screening \[yes, no\]), following multiple imputation procedure for missing data.||1.153|0.890|0.8415
72368775|NCT02983552|144247249|SUPERIORITY||||||>|0.99|||||||Cochran-Armitage trend test|||The frequency of diplopia, across categories of diplopia, was compared between the treatment groups using the Cochran-Armitage trend test.||||>0.99
72368776|NCT02983552|144247250|SUPERIORITY|||||||0.12|||||||Wilcoxon (Mann-Whitney)|||The exact Wilcoxon rank-sum test was used to compare the change in diplopia frequency levels from baseline to the 4-week visit by treatment group.||||0.12
72368777|NCT02983552|144247251|SUPERIORITY||||||>|0.99|||||||Wilcoxon (Mann-Whitney)|||The exact Wilcoxon rank-sum test was used to compare the change in diplopia frequency levels from baseline to the 8-week visit by treatment group.||||>0.99
72368778|NCT02983552|144247254|SUPERIORITY|||||||0.07|||||||Wilcoxon (Mann-Whitney)|||For each Symptom Survey item, the exact Wilcoxon rank-sum test was used to compare the change in symptom frequency level from baseline to the 4-week visit by treatment group.||||0.07
72368779|NCT02983552|144247255|SUPERIORITY|||||||0.06|||||||Wilcoxon (Mann-Whitney)|||For each Symptom Survey item, the exact Wilcoxon rank-sum test was used to compare the change in symptom frequency level from baseline to the 8-week visit by treatment group. This was utilized for each item in the survey.||||0.06
72368780|NCT02983552|144247258|SUPERIORITY||||||>|0.01||||||Statistical significance of the interaction term was based on a 2-sided alpha=0.01.|ANCOVA|||An analysis of covariance (ANCOVA) was performed to test the 2-way interaction between treatment group with each factor (baseline age and visual acuity were treated as continuous factors), adjusting for baseline amblyopic-eye visual acuity and the nested terms from the interaction term. Formal subgroup analyses were only performed if there was a minimum of 20 participants in every subgroup category across both treatment groups for factors treated as categorical variables in the model.||||>0.01
72368781|NCT00976560|144247264|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.6|STANDARD_DEVIATION|0.99|||TWO_SIDED|95.0|-2.54|1.35|||BMMRM|Bayesian Mixed Effects Model Repeated Measures (BMMRM)|Prior distribution of N(-4.1, 6.4009) incorporated into the posterior for the treatment difference at Week 6. The presented Confidence Interval is Highest Probability Density (HPD).||Posterior probability of the treatment difference being greater than 1.6 points in favor of GW856553 7.5mg BID as compared to placebo at Week 6 is 15.46 and for 0 is 72.98 and for 2 is 7.87.|1.35|-2.54|
72368782|NCT01216189|144247290|SUPERIORITY||Mean change|-0.138||||0.004|TWO_SIDED|95.0|-0.232|-0.044||The threshold for statistical significance was p = 0.05.|Regression, Linear|Model adjusted for menopausal status.||The change in serum testosterone levels between baseline and 1 year was assessed using longitudinal regression analysis (GEE).||-0.044|-0.232|0.004
72368783|NCT01216189|144247290|SUPERIORITY||Mean change|-0.011||||0.805|TWO_SIDED|95.0|-0.097|0.075||The threshold for statistical significance was p=0.05.|Regression, Linear|Model adjusted for menopausal status.||The change in serum testosterone levels between baseline and 1 year was assessed using longitudinal regression analysis (GEE).||0.075|-0.097|0.805
72368784|NCT01216189|144247291|SUPERIORITY||Mean change in FSFI scores|-9.33||||0.013|TWO_SIDED|95.0|-16.66|-1.99||The threshold for statistical significance was p=0.05.|Regression, Linear|Model adjusted for Age, Psychological General Well-being total score and relationship with partner.||"The association between mean change in total FSFI score and preoperative RT was assessed using longitudinal regression analysis (GEE), using no preoperative radiotherapy as the reference group."||-1.99|-16.66|0.013
72368785|NCT00125164|144247293|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.79|STANDARD_ERROR_OF_MEAN|0.3|<|0.0001||95.0|1.19|2.39||The two-sided p-values for the comparisons are adjusted for multiple comparisons using Dunnett's method.|ANCOVA|||The analysis compares each of the 80 and 120 µg/kg BID groups with the untreated control group using analysis of covariance (ANCOVA), where the covariates are the baseline height SD score stratum used in the randomization, the pretreatment height velocity, the baseline bone age, the baseline chronological age, and sex.||2.39|1.19|<0.0001
72368786|NCT00125164|144247293|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|2.58|STANDARD_ERROR_OF_MEAN|0.3|<|0.0001||95.0|1.99|3.16||The two-sided p-values for the comparisons are adjusted for multiple comparisons using Dunnett's method.|ANCOVA|||The analysis compares each of the 80 and 120 µg/kg BID groups with the untreated control group using analysis of covariance (ANCOVA), where the covariates are the baseline height SD score stratum used in the randomization, the pretreatment height velocity, the baseline bone age, the baseline chronological age, and sex.||3.16|1.99|< 0.0001
72368787|NCT00125164|144247293|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.79|STANDARD_ERROR_OF_MEAN|0.26||0.0032||95.0|0.27|1.31|||ANCOVA|||The analysis compares the 80 and 120 µg/kg BID groups using analysis of covariance (ANCOVA), where the covariates are the baseline height SD score stratum used in the randomization, the pretreatment height velocity, the baseline bone age, the baseline chronological age, and sex.||1.31|0.27|0.0032
72368788|NCT00125164|144247294|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.37|STANDARD_ERROR_OF_MEAN|0.07|<|0.0001||95.0|0.24|0.5||The two-sided p-values for the comparisons are adjusted for multiple comparisons using Dunnett's method.|ANCOVA|||The analysis compares each of the 80 and 120 µg/kg BID groups with the untreated control group using analysis of covariance (ANCOVA), where the covariates are the baseline height SD score stratum used in the randomization, the pretreatment height velocity, the baseline bone age, the baseline chronological age, and sex.||0.50|0.24|< 0.0001
72368789|NCT00125164|144247294|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.47|STANDARD_ERROR_OF_MEAN|0.06|<|0.0001||95.0|0.34|0.6||The two-sided p-values for the comparisons are adjusted for multiple comparisons using Dunnett's method.|ANCOVA|||The analysis compares each of the 80 and 120 µg/kg BID groups with the untreated control group using analysis of covariance (ANCOVA), where the covariates are the baseline height SD score stratum used in the randomization, the pretreatment height velocity, the baseline bone age, the baseline chronological age, and sex.||0.60|0.34|< 0.0001
72368790|NCT00125164|144247294|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.11|STANDARD_ERROR_OF_MEAN|0.05||0.0495||95.0|0.0|0.22|||ANCOVA|||The analysis compares the 80 and 120 µg/kg BID groups using analysis of covariance (ANCOVA), where the covariates are the baseline height SD score stratum used in the randomization, the pretreatment height velocity, the baseline bone age, the baseline chronological age, and sex.||0.22|0.00|0.0495
72369546|NCT00233064|144249499|SUPERIORITY_OR_OTHER||Overall percentage of immune reactivity|0.5||||||95.0|0.0|2.9|||||The number and percentage of subjects with immune reactivity at Study Day 240-300 were constructed using the Clopper-Pearson Method.|The subject number of 200 per treatment group was derived to demonstrate a percentage of immune reactivity in either the liquid or lyophilized formulations of palivizumab of \<2-3% based on 95% confidence intervals \[(0%; 0.00, 1.83), (0.5%; 0.01, 2.75), (1%; 0.12, 3.57)\].||2.9|0.0|
72363546|NCT01462370|144238258|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|0.1||||0.051|TWO_SIDED|95.0|0.0|0.2||A priori threshold for statistical significance = \<0.05.|ANOVA|Adjusted for treatment, period, sequence, patient (sequence), and baseline pain intensity (moderate or severe).||||0.20|-0.00|0.051
72363547|NCT01462370|144238259|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference in LS Means|0.17||||0.019|TWO_SIDED|95.0|0.03|0.32||A priori threshold for statistical significance = \<0.05.|ANOVA|Adjusted for treatment, period, sequence, patient (sequence), and baseline pain intensity (moderate or severe).||||0.32|0.03|0.019
72363548|NCT01462370|144238261|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|0.21|||<|0.001|TWO_SIDED|95.0|0.1|0.31||A priori threshold for statistical significance = \<0.05.|ANOVA|Adjusted for treatment, period, sequence, patient (sequence), and baseline pain intensity (moderate or severe).||||0.31|0.10|<0.001
72363549|NCT01462370|144238262|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|0.28||||0.002|TWO_SIDED|95.0|0.1|0.45||A priori threshold for statistical significance = \<0.05.|ANOVA|Adjusted for treatment, period, sequence, patient (sequence), and baseline pain intensity (moderate or severe).||||0.45|0.10|0.002
72363550|NCT01462370|144238263|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|0.11||||0.011|TWO_SIDED|95.0|0.03|0.2||A priori threshold for statistical significance = \<0.05.|ANOVA|Adjusted for treatment, period, sequence, patient (sequence), and baseline pain intensity (moderate or severe).||||0.20|0.03|0.011
72363551|NCT01462370|144238264|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|0.26||||0.004|TWO_SIDED|95.0|0.08|0.44||A priori threshold for statistical significance = \<0.05.|ANOVA|Adjusted for treatment, period, sequence, patient (sequence), and baseline pain intensity (moderate or severe).||||0.44|0.08|0.004
72363552|NCT01462370|144238265|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.6||||0.112|TWO_SIDED|95.0|0.9|2.87||A priori threshold for statistical significance = \<0.05.|Regression, Logistic|Adjusted for treatment, period, and baseline pain intensity.||||2.87|0.90|0.112
72363553|NCT01462370|144238266|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.97||||0.019|TWO_SIDED|95.0|1.12|3.45||A priori threshold for statistical significance = \<0.05.|Regression, Logistic|Adjusted for treatment, period, and baseline pain intensity.||||3.45|1.12|0.019
72363554|NCT02220920|144238267|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|0.11|<|0.001|TWO_SIDED|95.0|-1.33|-0.87|||ANCOVA|||||-0.87|-1.33|<0.001
72363555|NCT02220920|144238268|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-32.6|STANDARD_ERROR_OF_MEAN|6.9|<|0.001|TWO_SIDED|95.0|-46.3|-18.9|||ANCOVA|||||-18.9|-46.3|<0.001
72363556|NCT02220920|144238269|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-2.37|STANDARD_ERROR_OF_MEAN|0.36|<|0.001|TWO_SIDED|95.0|-3.09|-1.65|||ANCOVA|||||-1.65|-3.09|<0.001
72363557|NCT02220920|144238270|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-3.19|STANDARD_ERROR_OF_MEAN|1.67||0.058|TWO_SIDED|95.0|-6.49|0.11|||ANCOVA||Estimated P-Value, Least-Squares Mean Difference, Standard Error of the mean, 95% CI are presented for the change from Baseline in systolic blood pressure for week 16.|||0.11|-6.49|0.058
72363558|NCT02220920|144238270|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-1.24|STANDARD_ERROR_OF_MEAN|1.03||0.232|TWO_SIDED|95.0|-3.27|0.8|||ANCOVA||Estimated P-Value, Least-Squares Mean Difference, Standard Error of the mean, 95% CI are presented for the change from Baseline in diastolic blood pressure for week 16.|||0.80|-3.27|0.232
72363559|NCT04723056|144238274|OTHER|||||||0.282||||||The a priori threshold for statistical significance was \<0.05.|t-test, 2 sided|||Between-group analysis at week 8||||0.282
72363560|NCT04723056|144238275|OTHER|||||||0.217||||||The a priori threshold for statistical significance was \<0.05.|t-test, 2 sided|||Between-group analysis at week 24||||0.217
72363561|NCT04723056|144238276|OTHER|||||||0.462||||||The a priori threshold for statistical significance was \<0.05.|t-test, 2 sided|||Between-group analysis at week 8||||0.462
72363562|NCT04723056|144238276|OTHER|||||||0.179||||||The a priori threshold for statistical significance was \<0.05.|t-test, 2 sided|||Between-group analysis at week 24||||0.179
72363563|NCT04723056|144238277|OTHER|||||||0.573||||||The a priori threshold for statistical significance was \<0.05.|t-test, 2 sided|||Between-group analysis at week 8||||.573
72363564|NCT04723056|144238277|OTHER|||||||0.606||||||The a priori threshold for statistical significance was \<0.05.|t-test, 2 sided|||Between-group analysis at week 24||||.606
72363565|NCT04723056|144238278|OTHER|||||||0.181||||||The a priori threshold for statistical significance was \<0.05.|t-test, 2 sided|||Between-group analysis at week 24||||.181
72363566|NCT04723056|144238279|OTHER|||||||0.407||||||The a priori threshold for statistical significance was \<0.05.|t-test, 2 sided|||Between-group analysis at week 24||||.407
72363567|NCT04723056|144238280|OTHER|||||||0.643||||||The a priori threshold for statistical significance was \<0.05.|t-test, 2 sided|||Between-group analysis at week 24||||.643
72363568|NCT04723056|144238281|OTHER|||||||0.625||||||The a priori threshold for statistical significance was \<0.05.|t-test, 2 sided|||Between-group analysis at week 8||||.625
72363569|NCT04723056|144238281|OTHER|||||||0.707||||||The a priori threshold for statistical significance was \<0.05.|t-test, 2 sided|||Between-group analysis at week 24||||.707
72363570|NCT05106894|144238283|EQUIVALENCE|Adjusted difference between groups in composite scores calculated using an ordinary least squares linear regression model (with adjustments for sex of child, caregiver educational level, poverty score, birth weight and change in length for age Z score from 0 to 6 months).|Median Difference (Final Values)|-1.0|||||TWO_SIDED|95.0|-7.4|5.5||||||||5.5|-7.4|
72363571|NCT05106894|144238284|EQUIVALENCE|Adjusted difference between groups in composite scores calculated using an ordinary least squares linear regression model (with adjustments for sex of child, caregiver educational level, poverty score, birth weight and change in length for age Z score from 0 to 6 months).|Median Difference (Final Values)|-2.3|||||TWO_SIDED|95.0|-8.3|3.6||||||||3.6|-8.3|
72363572|NCT05106894|144238285|EQUIVALENCE|Adjusted difference between groups in composite scores calculated using an ordinary least squares linear regression model (with adjustments for sex of child, caregiver educational level, poverty score, birth weight and change in length for age Z score from 0 to 6 months).|Mean Difference (Final Values)|-1.8|||||TWO_SIDED|95.0|-5.6|2.1||||||||2.1|-5.6|
72368791|NCT00125164|144247302|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.83|STANDARD_ERROR_OF_MEAN|0.29|<|0.0001||95.0|1.26|2.4||The two-sided p-values for the comparisons are adjusted for multiple comparisons using Dunnett's method.|ANCOVA|||The analysis compares each of the 80 and 120 µg/kg BID groups with the untreated control group using analysis of covariance (ANCOVA), where the covariates are the baseline height SD score stratum used in the randomization, the pretreatment height velocity, the baseline bone age, the baseline chronological age, and sex.||2.40|1.26|<0.0001
72430084|NCT01053637|144371527|SUPERIORITY|||||||0.05||||||Pain at 5 minutes using Children's Hospital of Eastern Ontario Pain Scale validated in the younger population. Using a 2-point difference in CHEOPS pain scale as a clinically significant change, 34 patients were required in the younger 2- to 7 group.|Fisher Exact|||Children's Hospital of Eastern Ontario Pain Scale, for children 2-7 years. This score ranks 6 categories: Cry, Facial expression, Verbal Response, Torso movement, Touch, and Leg movement. The scale varies by each category from 0-2 or 1-2 or 1-3; such that a minimum score is 4 (no pain) and a maximum score is 13 signifying greatest or worst pain.||||0.05
72430085|NCT01053637|144371528|OTHER|||||||0.05|||||||Wilcoxon (Mann-Whitney)|||State-Trait Anxiety Inventory for Children pre vs. post procedure for matched pairs. Higher numbers indicated higher state anxiety. State Trait Anxiety Inventory for Children (STAIC) scores pre vs. post procedure for matched pairs. A lower STAIC score indicates less anxiety and a greater score indicates more anxiety based on Likert-type scales and analyzed using nonparametric testing.||||0.05
72430086|NCT03317379|144371555|SUPERIORITY||estimate of fixed effects|0.03|STANDARD_ERROR_OF_MEAN|0.1||0.8|TWO_SIDED|95.0|-0.17|0.22||.05 is the a priori threshold for statistical significance.|Mixed Models Analysis|||||0.22|-0.17|.80
72430087|NCT03317379|144371555|SUPERIORITY||estimate of fixed effects|0.1|STANDARD_ERROR_OF_MEAN|0.1||0.32|TWO_SIDED|95.0|-0.1|0.3||.05 is the a priori threshold for statistical significance.|Mixed Models Analysis|||||0.30|-0.10|.32
72430088|NCT03317379|144371556|SUPERIORITY||estimate of fixed effects|0.14|STANDARD_ERROR_OF_MEAN|0.05||0.01|TWO_SIDED|95.0|0.03|0.24||.05 is the a priori threshold for statistical significance.|Mixed Models Analysis|||||0.24|0.03|0.01
72430089|NCT03317379|144371556|SUPERIORITY||estimate of fixed effects|0.08|STANDARD_ERROR_OF_MEAN|0.07||0.28|TWO_SIDED|95.0|-0.07|0.23||.05 is the a priori threshold for statistical significance.|Mixed Models Analysis|||||0.23|-.07|0.28
72430090|NCT03317379|144371557|SUPERIORITY||estimate of fixed effects|0.61|STANDARD_ERROR_OF_MEAN|0.28||0.03|TWO_SIDED|95.0|0.06|1.16||.05 is the a priori threshold for statistical significance.|Mixed Models Analysis|||||1.16|0.06|0.03
72430091|NCT03317379|144371557|SUPERIORITY||estimate of fixed effects|0.68|STANDARD_ERROR_OF_MEAN|0.29||0.02|TWO_SIDED|95.0|0.09|1.27|||Mixed Models Analysis|||||1.27|0.09|0.02
72430092|NCT03317379|144371558|SUPERIORITY||estimate of fixed effects|0.2|STANDARD_ERROR_OF_MEAN|0.11||0.08|TWO_SIDED|95.0|-0.02|0.42||.05 is the a priori threshold for statistical significance.|Mixed Models Analysis|||||0.42|-0.02|0.08
72430093|NCT03317379|144371558|SUPERIORITY||estimate of fixed effects|0.18|STANDARD_ERROR_OF_MEAN|0.12||0.12|TWO_SIDED|95.0|-0.04|0.41||.05 is the a priori threshold for statistical significance.|Mixed Models Analysis|||||0.41|-0.04|0.12
72430094|NCT03317379|144371559|SUPERIORITY||estimate of fixed effects|0.03|STANDARD_ERROR_OF_MEAN|0.22||0.18|TWO_SIDED|95.0|-0.14|0.74||the a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|||||0.74|-0.14|0.18
72430095|NCT03317379|144371559|SUPERIORITY||estimate of fixed effects|0.16|STANDARD_ERROR_OF_MEAN|0.23||0.5|TWO_SIDED|95.0|-0.3|0.62||the a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|||||0.62|-0.30|0.50
72430096|NCT03824535|144371566|SUPERIORITY|||||||0.02||||||The threshold for statistical significance was set at p \< 0.05|Wilcoxon (Mann-Whitney)|||Analysis applies to the row 'Specificity' in the Outcome Measure data table.||||0.02
72430097|NCT03824535|144371567|SUPERIORITY|||||||0.004||||||The threshold for statistical significance was predefined as p \< 0.05|Wilcoxon (Mann-Whitney)|||||||0.004
72430098|NCT03824535|144371567|SUPERIORITY|||||||0.05||||||The threshold for statistical significance was predefined as p ≤ 0.05.|Wilcoxon (Mann-Whitney)|||||||0.05
72430099|NCT03824535|144371567|SUPERIORITY|||||||0.06||||||The threshold for statistical significance was predefined as p \< 0.05.|Wilcoxon (Mann-Whitney)|||||||0.06
72430100|NCT01682538|144371568|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was established if the 90% confidence interval of the ratio was completely within the acceptance range (0.80-1.25)|Ratio of geometric means|0.858|||||TWO_SIDED|90.0|0.81|0.91|||ANOVA|||||0.91|0.81|
72430101|NCT01682538|144371569|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was established if the 90% confidence interval of the ratio was completely within the acceptance range (0.80-1.25)|Ratio of geometric means|0.954|||||TWO_SIDED|90.0|0.85|1.07|||ANOVA|||||1.07|0.85|
72430102|NCT01682538|144371570|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence (no food effect) was established if the 90% confidence interval of the ratio was completely within the acceptance range (0.80 - 1.25).|Ratio of geometric means|1.013|||||TWO_SIDED|90.0|0.96|1.07|||ANOVA|||||1.07|0.96|
72430103|NCT01682538|144371571|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence (no food effect) was established if the 90% confidence interval of the ratio was completely within the acceptance range (0.80 - 1.25)|Ratio of geometric means|0.802|||||TWO_SIDED|90.0|0.71|0.9|||ANOVA|||||0.90|0.71|
72430104|NCT00802841|144371582|SUPERIORITY_OR_OTHER|||||||0.3106|TWO_SIDED||||||Fisher Exact|||||||0.3106
72430105|NCT00377741|144371608|SUPERIORITY_OR_OTHER||Mean exposure ratio for AUC(0-tau)|1.24|||||TWO_SIDED|90.0|0.98|1.55||||||||1.55|0.98|
72430106|NCT00377741|144371609|SUPERIORITY_OR_OTHER||Mean exposure ratio for Cmax|1.12|||||TWO_SIDED|90.0|0.88|1.42||||||||1.42|0.88|
72430107|NCT03531905|144371622|SUPERIORITY||Difference of Least Squares (LS) means|-39.6|STANDARD_ERROR_OF_MEAN|3.14|<|0.001|TWO_SIDED|95.0|-45.8|-33.4|||ANCOVA|||||-33.4|-45.8|<0.001
72430108|NCT03531905|144371622|SUPERIORITY||Difference of LS means|-19.5|STANDARD_ERROR_OF_MEAN|3.11|<|0.001|TWO_SIDED|95.0|-25.7|-13.4|||ANCOVA|||||-13.4|-25.7|<0.001
72430109|NCT03531905|144371622|SUPERIORITY||Difference of LS means|-20.1|STANDARD_ERROR_OF_MEAN|3.08|<|0.001|TWO_SIDED|95.0|-26.2|-14.0|||ANCOVA|||||-14.0|-26.2|<0.001
72430110|NCT03531905|144371623|SUPERIORITY||Difference of LS means|-20.1|STANDARD_ERROR_OF_MEAN|3.08|<|0.001|TWO_SIDED|95.0|-26.2|-14.0|||ANCOVA|||||-14.0|-26.2|<0.001
72430111|NCT03531905|144371624|SUPERIORITY||Location shift|-36.7|STANDARD_ERROR_OF_MEAN|9.77|<|0.001|TWO_SIDED|95.0|-55.97|-17.67|||Wilcoxon rank sum test|||||-17.67|-55.97|<0.001
72430112|NCT03531905|144371624|SUPERIORITY||Location shift|-29.2|STANDARD_ERROR_OF_MEAN|10.03||0.005|TWO_SIDED|95.0|-48.92|-9.62|||Wilcoxon rank sum test|||||-9.62|-48.92|0.005
72430113|NCT03531905|144371624|SUPERIORITY||Location shift|-7.5|STANDARD_ERROR_OF_MEAN|11.29||0.48|TWO_SIDED|95.0|-30.51|13.76|||Wilcoxon rank sum test|||||13.76|-30.51|0.480
72430114|NCT03531905|144371625|SUPERIORITY||Difference of LS means|-33.1|STANDARD_ERROR_OF_MEAN|2.81|<|0.001|TWO_SIDED|95.0|-38.6|-27.5|||ANCOVA|||||-27.5|-38.6|<0.001
72430115|NCT03531905|144371625|SUPERIORITY||Difference of LS means|-15.3|STANDARD_ERROR_OF_MEAN|2.8|<|0.001|TWO_SIDED|95.0|-20.8|-9.7|||ANCOVA|||||-9.7|-20.8|<0.001
72430116|NCT03531905|144371625|SUPERIORITY||Difference of LS means|-17.8|STANDARD_ERROR_OF_MEAN|2.76|<|0.001|TWO_SIDED|95.0|-23.3|-12.4|||ANCOVA|||||-12.4|-23.3|<0.001
72363573|NCT04196777|144238338|OTHER|We performed a logistic regression analysis that measured the effect of the intervention at site 3. The below results show the interaction term between time and the intervention from this model. Time was measured in days divided by 365, giving an annualized figure for the time coefficient estimate and interaction coefficient.|Odds Ratio (OR)|0.089||||0.004|TWO_SIDED|95.0|0.016|0.445|||Regression, Logistic|||To model the primary outcome for site 3, we used a logistic regression model and a set of three explanatory variables: time, a binary indicator for an observation occurring within the intervention phase, and an interaction term between these two main effects (time and intervention).||0.445|0.016|0.004
72363574|NCT04196777|144238338|OTHER|We performed a logistic regression analysis that measured the effect of the intervention at site 1. The below results show the interaction term between time and the intervention from this model. Time was measured in days divided by 365, giving an annualized figure for the time coefficient estimate and interaction coefficient.|Odds Ratio (OR)|1.593||||0.259|TWO_SIDED|95.0|0.71|3.585|||Regression, Logistic|||To model the primary outcome for site 1, we used a logistic regression model and a set of three explanatory variables: time, a binary indicator for an observation occurring within the intervention phase, and an interaction term between these two main effects (time and intervention).||3.585|0.710|0.259
72363575|NCT04196777|144238338|OTHER|We performed a logistic regression analysis that measured the effect of the intervention at site 2. The below results show the interaction term between time and the intervention from this model. Time was measured in days divided by 365, giving an annualized figure for the time coefficient estimate and interaction coefficient.|Odds Ratio (OR)|0.748||||0.738|TWO_SIDED|95.0|0.135|4.147|||Regression, Logistic|||To model the primary outcome for site 2, we used a logistic regression model and a set of three explanatory variables: time, a binary indicator for an observation occurring within the intervention phase, and an interaction term between these two main effects (time and intervention).||4.147|0.135|0.738
72363576|NCT04196777|144238339|OTHER|The Wilcoxon rank-sum test assessed whether the post-procedural antimicrobial duration significantly differed at site 3 between the baseline and intervention periods.|Rank sum test statistic|1280.5||||0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||The median duration of post-procedural antimicrobial prescriptions at site 3 were compared using the Wilcoxon rank-sum test.||||0.001
72363577|NCT04196777|144238339|OTHER|The Wilcoxon rank-sum test assessed whether the post-procedural antimicrobial duration significantly differed at site 1 between the baseline and intervention periods.|Rank sum test statistic|28662.0||||0.013|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||The median duration of post-procedural antimicrobial prescriptions at site 1 were compared using the Wilcoxon rank-sum test.Type of statistical test||||0.013
72363578|NCT04196777|144238339|OTHER|The Wilcoxon rank-sum test assessed whether the post-procedural antimicrobial duration significantly differed at site 2 between the baseline and intervention periods.|Rank sum test statistic|784.0||||0.14|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||The median duration of post-procedural antimicrobial prescriptions at site 2 were compared using the Wilcoxon rank-sum test.||||0.14
72363579|NCT04196777|144238340|OTHER|We performed a logistic regression model that included patients across all 3 sites.|Odds Ratio (OR)|0.76||||0.04|TWO_SIDED|95.0|0.58|0.99|||Regression, Logistic|||To model this secondary outcome, we used a logistic regression model and a set of four explanatory variables: time, a binary indicator for an observation occurring within the intervention phase, an interaction term between these two main effects (time and intervention), and a binary indicator for the primary outcome. This last variable was included to assess the risk of these secondary outcomes in patients who were not exposed to post-procedural antimicrobials compared to those who were exposed.||0.99|0.58|0.04
72363580|NCT04196777|144238341|OTHER|We performed a logistic regression model that included patients across all 3 sites.|Odds Ratio (OR)|0.68|||<|0.01|TWO_SIDED|95.0|0.53|0.87|||Regression, Logistic|||To model this secondary outcome across all sites, we used a logistic regression model and a set of four explanatory variables: time, a binary indicator for an observation occurring within the intervention phase, an interaction term between these two main effects (time and intervention), and a binary indicator for the primary outcome.||0.87|0.53|<0.01
72363581|NCT00981656|144238348|OTHER|No testing is done, conclusions are made based on the confidence interval.||||||||||||||||Null hypothesis = this treatment will result in 75% of participants free from radical cystectomy at 3 years. A lower confidence bound of 60% will be promising enough to pursue this regimen further. A sample size of 33 analyzable patients provides a one-sided 97.5% lower bound of 60% relative to the hypothesized 75%. In terms of type I error, this design provides a 2.5% chance of observing a 3-year percentage less than 60% if the true rate is 75%.|If the lower confidence interval (CI) limit was above 60% then the regimen would be considered promising enough to warrant further study for this treatment regimen. If the lower limit was below 25% then the treatment would not be considered worthy of further study. If the lower limit fell between 25% and 60%, the investigators would consider the possibility of further investigation.|||
72363582|NCT00837434|144238409|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3|TWO_SIDED||||||ANCOVA|P-value for testing treatment effect uses week 12 CD27+ switched memory as the outcome variable and adjusts for baseline CD27+ switched memory||Null Hypothesis: Mean percentage of CD27+ switched memory cells in the peripheral blood at Week 12 does not differ between individuals treated with etanercept and those treated with adalimumab after adjusting for baseline CD27+ switched memory cells. Alt. hypothesis: Mean percentage of CD27+ switched memory cells in the peripheral blood at Week 12 in individuals treated with etanercept is lower than in those treated with adalimumab after adjusting for baseline CD27+ switched memory cells.||||0.3
72363583|NCT01122238|144238416|SUPERIORITY_OR_OTHER|||||||0.665|TWO_SIDED||||||ANCOVA|The mean values tested and reported consist of residualized change scores from the ANCOVA.||The ANCOVA model included intervention main effects and intervention interactions plus baseline cigarettes per day, education, race, and time to first daily cigarette as covariates. Intervention main effects included Nicotine Patch vs. No Nicotine Patch; Nicotine Gum vs. No Nicotine Gum; Smoking Reduction vs. No Smoking Reduction; and Motivational Interviewing vs. No Motivational Interviewing.||||.665
72430117|NCT03531905|144371626|SUPERIORITY||Difference of LS means|-27.2|STANDARD_ERROR_OF_MEAN|2.25|<|0.001|TWO_SIDED|95.0|-31.7|-22.8|||ANCOVA|||||-22.8|-31.7|<0.001
72430118|NCT03531905|144371626|SUPERIORITY||Difference of LS means|-13.4|STANDARD_ERROR_OF_MEAN|2.24|<|0.001|TWO_SIDED|95.0|-17.8|-9.0|||ANCOVA|||||-9.0|-17.8|<0.001
72430119|NCT03531905|144371626|SUPERIORITY||Difference of LS means|-13.9|STANDARD_ERROR_OF_MEAN|2.21|<|0.001|TWO_SIDED|95.0|-18.2|-9.5|||ANCOVA|||||-9.5|-18.2|<0.001
72430120|NCT03531905|144371627|SUPERIORITY||Difference of LS means|-27.2|STANDARD_ERROR_OF_MEAN|2.73|<|0.001|TWO_SIDED|95.0|-32.6|-21.8|||ANCOVA|||||-21.8|-32.6|<0.001
72430121|NCT03531905|144371627|SUPERIORITY||Difference of LS means|-12.8|STANDARD_ERROR_OF_MEAN|2.71|<|0.001|TWO_SIDED|95.0|-18.1|-7.4|||ANCOVA|||||-7.4|-18.1|<0.001
72430122|NCT03531905|144371627|SUPERIORITY||Difference of LS means|-14.4|STANDARD_ERROR_OF_MEAN|2.68|<|0.001|TWO_SIDED|95.0|-19.7|-9.1|||ANCOVA|||||-9.1|-19.7|<0.001
72430123|NCT03531905|144371628|SUPERIORITY||Location shift|-3.9|STANDARD_ERROR_OF_MEAN|5.44||0.457|TWO_SIDED|95.0|-14.55|6.79|||Wilcoxon rank sum test|||||6.79|-14.55|0.457
72430124|NCT03531905|144371628|SUPERIORITY||Difference of LS means|4.7|STANDARD_ERROR_OF_MEAN|5.25||0.351|TWO_SIDED|95.0|-4.93|15.63|||ANCOVA|||||15.63|-4.93|0.351
72430125|NCT03531905|144371628|SUPERIORITY||Difference of LS means|-9.2|STANDARD_ERROR_OF_MEAN|4.75||0.068|TWO_SIDED|95.0|-17.92|0.68|||ANCOVA|||||0.68|-17.92|0.068
72430126|NCT03531905|144371629|SUPERIORITY||Difference of LS means|-5.9|STANDARD_ERROR_OF_MEAN|2.14||0.007|TWO_SIDED|95.0|-10.1|-1.7|||ANCOVA|||||-1.7|-10.1|0.007
72430127|NCT03531905|144371629|SUPERIORITY||Difference of LS means|-7.3|STANDARD_ERROR_OF_MEAN|2.12|<|0.001|TWO_SIDED|95.0|-11.5|-3.1|||ANCOVA|||||-3.1|-11.5|<0.001
72430128|NCT03531905|144371629|SUPERIORITY||Difference of LS means|1.4|STANDARD_ERROR_OF_MEAN|2.11||0.517|TWO_SIDED|95.0|-2.8|5.5|||ANCOVA|||||5.5|-2.8|0.517
72430129|NCT03531905|144371630|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||<0.001
72430130|NCT03531905|144371630|SUPERIORITY|||||||0.118|||||||Fisher Exact|||||||0.118
72430131|NCT03531905|144371630|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||<0.001
72430132|NCT03531905|144371631|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||<0.001
72430133|NCT03531905|144371631|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||<0.001
72430134|NCT03531905|144371633|SUPERIORITY||Difference of LS means|-0.3|STANDARD_ERROR_OF_MEAN|1.83||0.877|TWO_SIDED|95.0|-3.9|3.3|||ANCOVA|||||3.3|-3.9|0.877
72430135|NCT03531905|144371633|SUPERIORITY||Difference of LS means|0.8|STANDARD_ERROR_OF_MEAN|1.83||0.669|TWO_SIDED|95.0|-2.8|4.4|||ANCOVA|||||4.4|-2.8|0.669
72430136|NCT03531905|144371633|SUPERIORITY||Difference of LS means|-1.1|STANDARD_ERROR_OF_MEAN|1.81||0.556|TWO_SIDED|95.0|-4.6|2.5|||ANCOVA|||||2.5|-4.6|0.556
72430137|NCT03531905|144371634|SUPERIORITY||Difference of LS means|2.5|STANDARD_ERROR_OF_MEAN|4.64||0.589|TWO_SIDED|95.0|-6.7|11.7|||ANCOVA|||||11.7|-6.7|0.589
72430138|NCT03531905|144371634|SUPERIORITY||Difference of LS means|0.6|STANDARD_ERROR_OF_MEAN|4.64||0.904|TWO_SIDED|95.0|-8.6|9.7|||ANCOVA|||||9.7|-8.6|0.904
72430139|NCT03531905|144371634|SUPERIORITY||Difference of LS means|2.0|STANDARD_ERROR_OF_MEAN|4.66||0.676|TWO_SIDED|95.0|-7.3|11.2|||ANCOVA|||||11.2|-7.3|0.676
72430140|NCT03531905|144371636|SUPERIORITY||Difference of LS means|-15.8|STANDARD_ERROR_OF_MEAN|13.95||0.258|TWO_SIDED|95.0|-43.4|11.7|||ANCOVA|||||11.7|-43.4|0.258
72430141|NCT03531905|144371636|SUPERIORITY||Difference of LS means|0.5|STANDARD_ERROR_OF_MEAN|13.79||0.972|TWO_SIDED|95.0|-26.8|27.7|||ANCOVA|||||27.7|-26.8|0.972
72430142|NCT03531905|144371636|SUPERIORITY||Difference of LS means|-16.3|STANDARD_ERROR_OF_MEAN|13.68||0.235|TWO_SIDED|95.0|-43.3|10.7|||ANCOVA|||||10.7|-43.3|0.235
72430143|NCT02264574|144371716|SUPERIORITY||Hazard Ratio (HR)|0.231|||<|0.0001|TWO_SIDED|95.0|0.145|0.367|||Log Rank|The treatment effect was tested with an unstratified log rank test.|The hazard ratio and its 95% confidence interval were estimated using a Cox regression model with treatment as the only covariate.|To preserve the study wise type I error rate of 0.05, the primary and secondary endpoints were tested based on serial gatekeeping testing procedure at the two-sided significance level of 0.05 according to the hierarchical order of the primary analysis outcome measures presented in this record.||0.367|0.145|<0.0001
72430144|NCT02264574|144371717|SUPERIORITY||Hazard Ratio (HR)|0.119|||<|0.0001|TWO_SIDED|95.0|0.046|0.307|||Log Rank|The treatment effect was tested with an unstratified log rank test.|The hazard ratio and its 95% confidence interval were estimated using a Cox regression model with treatment as the only covariate.|To preserve the study wise type I error rate of 0.05, the primary and secondary endpoints were tested based on serial gatekeeping testing procedure at the two-sided significance level of 0.05 according to the hierarchical order of the primary analysis outcome measures presented in this record.||0.307|0.046|< 0.0001
72430145|NCT02264574|144371718|SUPERIORITY|||||||0.5253|||||||Chi-squared|||To preserve the study wise type I error rate of 0.05, the primary and secondary endpoints were tested based on serial gatekeeping testing procedure at the two-sided significance level of 0.05 according to the hierarchical order of the primary analysis outcome measures presented in this record.||||0.5253
72430146|NCT02264574|144371719|SUPERIORITY|||||||0.5465|||||||Chi-squared|||To preserve the study wise type I error rate of 0.05, the primary and secondary endpoints were tested based on serial gatekeeping testing procedure at the two-sided significance level of 0.05 according to the hierarchical order of the primary analysis outcome measures presented in this record.||||0.5465
72430147|NCT02264574|144371720|SUPERIORITY||Rate Ratio|1.208||||0.0035|TWO_SIDED|95.0|1.062|1.373|||Chi-squared|||To preserve the study wise type I error rate of 0.05, the primary and secondary endpoints were tested based on serial gatekeeping testing procedure at the two-sided significance level of 0.05 according to the hierarchical order of the primary analysis outcome measures presented in this record.||1.373|1.062|0.0035
72430148|NCT02264574|144371721|SUPERIORITY||Hazard Ratio (HR)|0.921||||0.8057|TWO_SIDED|95.0|0.479|1.772|||Log Rank|The treatment effect was tested with an unstratified log rank test.|The hazard ratio and its 95% confidence interval were estimated using a Cox regression model with treatment as the only covariate.|To preserve the study wise type I error rate of 0.05, the primary and secondary endpoints were tested based on serial gatekeeping testing procedure at the two-sided significance level of 0.05 according to the hierarchical order of the primary analysis outcome measures presented in this record.||1.772|0.479|0.8057
72430149|NCT02264574|144371722|SUPERIORITY|||||||0.0835|||||||Fisher Exact|||"IRR Preferred Term~To preserve the study wise type I error rate of 0.05, the primary and secondary endpoints were tested based on serial gatekeeping testing procedure at the two-sided significance level of 0.05 according to the hierarchical order of the primary analysis outcome measures presented in this record."||||0.0835
72430150|NCT02264574|144371722|SUPERIORITY|||||||0.1944|||||||Fisher Exact|||"IRR By Customized SMQ~To preserve the study wise type I error rate of 0.05, the primary and secondary endpoints were tested based on serial gatekeeping testing procedure at the two-sided significance level of 0.05 according to the hierarchical order of the primary analysis outcome measures presented in this record."||||0.1944
72430151|NCT02264574|144371723|SUPERIORITY|||||||0.0045|||||||Chi-squared|||To preserve the study wise type I error rate of 0.05, the primary and secondary endpoints were tested based on serial gatekeeping testing procedure at the two-sided significance level of 0.05 according to the hierarchical order of the primary analysis outcome measures presented in this record.||||0.0045
72430152|NCT02264574|144371724|SUPERIORITY|||||||0.859|||||||Chi-squared|||To preserve the study wise type I error rate of 0.05, the primary and secondary endpoints were tested based on serial gatekeeping testing procedure at the two-sided significance level of 0.05 according to the hierarchical order of the primary analysis outcome measures presented in this record.||||0.8590
72430153|NCT02264574|144371725|SUPERIORITY||Hazard Ratio (HR)|0.169|||<|0.0001|TWO_SIDED|95.0|0.102|0.282|||Log Rank|The treatment effect was tested with an unstratified log rank test.|The hazard ratio and its 95% confidence interval were estimated using a Cox regression model with treatment as the only covariate.|||0.282|0.102|< 0.0001
72430154|NCT02264574|144371726|SUPERIORITY|||||||0.9657|||||||Chi-squared|||||||0.9657
72430155|NCT02264574|144371727|SUPERIORITY|||||||0.1612|||||||Chi-squared|||||||0.1612
72430156|NCT02264574|144371728|SUPERIORITY||Rate Ratio|1.125||||0.0273|TWO_SIDED|95.0|1.013|1.25|||Chi-squared|||||1.250|1.013|0.0273
72430157|NCT02264574|144371729|SUPERIORITY||Hazard Ratio (HR)|1.083||||0.7934|TWO_SIDED|95.0|0.595|1.973|||Log Rank|The treatment effect was tested with an unstratified log rank test.|The hazard ratio and its 95% confidence interval were estimated using a Cox regression model with treatment as the only covariate.|||1.973|0.595|0.7934
72430158|NCT02264574|144371730|SUPERIORITY|||||||0.005|||||||Chi-squared|||||||0.0050
72430159|NCT02264574|144371731|SUPERIORITY||Hazard Ratio (HR)|0.251|||<|0.0001|TWO_SIDED|95.0|0.162|0.389|||Log Rank|The treatment effect was tested with an unstratified log rank test.|The hazard ratio and its 95% confidence interval were estimated using a Cox regression model with treatment as the only covariate.|||0.389|0.162|< 0.0001
72430160|NCT02886728|144371732|SUPERIORITY||Difference in Response Rates|9.6|||<|0.001|TWO_SIDED|95.0|3.6|15.6||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 24||15.6|3.6|<0.001
72430161|NCT02886728|144371732|SUPERIORITY||Difference in Response Rates|8.8||||0.017|TWO_SIDED|95.0|1.5|16.1||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 24||16.1|1.5|0.017
72430162|NCT02886728|144371732|SUPERIORITY||Difference in Response Rates|6.7||||0.058|TWO_SIDED|95.0|-0.7|14.1||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 24||14.1|-0.7|0.058
72430163|NCT02886728|144371733|SUPERIORITY||Least Squares Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.041|<|0.001|TWO_SIDED|95.0|-0.27|-0.11||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from mixed effects model for repeated measures (MMRM). Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.11|-0.27|<0.001
72430164|NCT02886728|144371733|SUPERIORITY||Least Squares Mean Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.049||0.009|TWO_SIDED|95.0|-0.23|-0.03||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.03|-0.23|0.009
72430165|NCT02886728|144371733|SUPERIORITY||Least Squares Mean Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.05||0.032|TWO_SIDED|95.0|-0.2|-0.01||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.01|-0.20|0.032
72430166|NCT02886728|144371734|SUPERIORITY||Difference in Response Rates|25.0|||<|0.001|TWO_SIDED|95.0|18.3|31.7||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 24||31.7|18.3|<0.001
72430167|NCT02886728|144371734|SUPERIORITY||Difference in Response Rates|13.4|||<|0.001|TWO_SIDED|95.0|5.0|21.8||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 24||21.8|5.0|<0.001
72430168|NCT02886728|144371734|SUPERIORITY||Difference in Response Rates|13.3|||<|0.001|TWO_SIDED|95.0|5.0|21.6||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 24||21.6|5.0|<0.001
72430169|NCT02886728|144371735|SUPERIORITY||Least Squares Mean Difference|-0.29|STANDARD_ERROR_OF_MEAN|0.161||0.068|TWO_SIDED|95.0|-0.61|0.02||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||0.02|-0.61|0.068
72430170|NCT02886728|144371735|SUPERIORITY||Least Squares Mean Difference|-0.29|STANDARD_ERROR_OF_MEAN|0.195||0.14|TWO_SIDED|95.0|-0.67|0.1||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||0.10|-0.67|0.14
72363584|NCT01122238|144238416|SUPERIORITY_OR_OTHER|||||||0.562|TWO_SIDED||||||ANCOVA|The mean values tested and reported consist of residualized change scores from the ANCOVA.||The ANCOVA model included intervention main effects and intervention interactions plus baseline cigarettes per day, education, race, and time to first daily cigarette as covariates. Intervention main effects included Nicotine Patch vs. No Nicotine Patch; Nicotine Gum vs. No Nicotine Gum; Smoking Reduction vs. No Smoking Reduction; and Motivational Interviewing vs. No Motivational Interviewing.||||.562
72363585|NCT01122238|144238416|SUPERIORITY_OR_OTHER|||||||0.536|TWO_SIDED||||||ANCOVA|The mean values tested and reported consist of residualized change scores from the ANCOVA.||The ANCOVA model included intervention main effects and intervention interactions plus baseline cigarettes per day, education, race, and time to first daily cigarette as covariates. Intervention main effects included Nicotine Patch vs. No Nicotine Patch; Nicotine Gum vs. No Nicotine Gum; Smoking Reduction vs. No Smoking Reduction; and Motivational Interviewing vs. No Motivational Interviewing.||||.536
72363586|NCT01122238|144238416|SUPERIORITY_OR_OTHER|||||||0.206|TWO_SIDED||||||ANCOVA|The mean values tested and reported consist of residualized change scores from the ANCOVA.||The ANCOVA model included intervention main effects and intervention interactions plus baseline cigarettes per day, education, race, and time to first daily cigarette as covariates. Intervention main effects included Nicotine Patch vs. No Nicotine Patch; Nicotine Gum vs. No Nicotine Gum; Smoking Reduction vs. No Smoking Reduction; and Motivational Interviewing vs. No Motivational Interviewing.||||.206
72363587|NCT01122238|144238417|SUPERIORITY_OR_OTHER||Standardized Regression Coefficient|0.0||||0.98|TWO_SIDED||||||Regression, Linear|||The linear regression model effects consisted of four treatment main effects, six two-way treatment interactions, four three-way treatment interactions, and one four-way interaction. Only the results for the treatment main effects are being reported in ClinicalTrials.gov.||||.98
72363588|NCT01122238|144238417|SUPERIORITY_OR_OTHER||Standardized Regression Coefficient|-0.04||||0.4|TWO_SIDED||||||Regression, Linear|||The linear regression model effects consisted of four treatment main effects, six two-way treatment interactions, four three-way treatment interactions, and one four-way interaction. Only the results for the treatment main effects are being reported in ClinicalTrials.gov.||||.40
72363589|NCT01122238|144238417|SUPERIORITY_OR_OTHER||Standardized Regression Coefficient|0.0||||0.99|TWO_SIDED||||||Regression, Linear|||The linear regression model effects consisted of four treatment main effects, six two-way treatment interactions, four three-way treatment interactions, and one four-way interaction. Only the results for the treatment main effects are being reported in ClinicalTrials.gov.||||.99
72363590|NCT01122238|144238417|SUPERIORITY_OR_OTHER||Standardized Regression Coefficient|-0.04||||0.33|TWO_SIDED||||||Regression, Linear|||The linear regression model effects consisted of four treatment main effects, six two-way treatment interactions, four three-way treatment interactions, and one four-way interaction. Only the results for the treatment main effects are being reported in ClinicalTrials.gov.||||.33
72363591|NCT02121158|144238439|EQUIVALENCE|Unadjusted|Hazard Ratio (HR)|0.915||||0.7457|TWO_SIDED|95.0|0.534|1.568|||Cox Proportional Hazards|||||1.568|0.534|0.7457
72363592|NCT00459316|144238455|SUPERIORITY_OR_OTHER_LEGACY|||||||0.03||||||Two-sided p-value \<0.05 was specified as statistically significant a priori. There were no adjustments for multiple outcomes.|Fisher Exact|||The null hypothesis was that there would be no difference between CD4% strata.||||0.03
72363593|NCT00459316|144238456|SUPERIORITY_OR_OTHER_LEGACY|||||||0.01||||||Two sided-p-value \<0.05 was specified as statistically significant a priori. No adjustment for multiple primary outcomes was made.|Fisher Exact|||The null hypothesis was that there were no differences between CD4% strata.||||0.01
72363594|NCT03044106|144238488|SUPERIORITY||Mean Difference (Final Values)|3.825|STANDARD_DEVIATION|3.308759||0.0068|TWO_SIDED|95.0|1.058809|6.591192|||t-test, 2 sided|||This is the difference between pre and post KEA in those receiving the active treatment with a history of hamstring strain.||6.591192|1.058809|0.0068
72363595|NCT03044106|144238488|SUPERIORITY||Median Difference (Final Values)|1.0|STANDARD_DEVIATION|3.431784||0.2185|TWO_SIDED|95.0|-1.869044|3.869044|||t-test, 2 sided|||This is the difference in pre /post KEA means after receiving the sham treatment in those with a history of hamstring strains.||3.869044|-1.869044|0.2185
72363596|NCT03044106|144238488|SUPERIORITY||Mean Difference (Final Values)|0.6638904|STANDARD_DEVIATION|3.450892||0.1281|TWO_SIDED|95.0|-0.5037233|1.831504|||t-test, 2 sided|||This is the difference in pre/post KEA means in those receiving the active treatment with no history of hamstring strain.||1.831504|-.5037233|0.1281
72363597|NCT03044106|144238488|SUPERIORITY||Mean Difference (Final Values)|2.688237|STANDARD_DEVIATION|3.241751||0|TWO_SIDED|95.0|1.557137|3.819337|||t-test, 2 sided|||This is the difference in pre/post KEA means in those receiving the sham treatment who have no history of hamstring strain.||3.819337|1.557137|0.00
72363598|NCT03044106|144238488|SUPERIORITY||Mean Difference (Final Values)|2.825||||0.09|TWO_SIDED|95.0|-0.4543|6.0581|||Mixed Models Analysis|||This is the mean difference in effect between active and sham in those with a history of hamstring strain||6.0581|-0.4543|0.090
72363599|NCT03044106|144238488|SUPERIORITY||Mean Difference (Final Values)|-2.024||||0.018|TWO_SIDED|95.0|-3.4474|-0.3406|||Mixed Models Analysis|||This is the mean difference of effect between active and sham in those without a history of hamstring strain.||-0.3406|-3.4474|0.018
72363600|NCT03367793|144238542|OTHER||f statistic|1.1||||0.341|TWO_SIDED|||||The threshold for statistical significance was 0.05.|Mixed Models Analysis|||It was calculated that 29 participants randomized in a 3x3 within-subject crossover design (repeated measures) achieves at least 89% power to detect an effect size of 0.25. Sample size was determined by a 2-sided f-test (alpha = 0.05) of the overall treatment effect based on a statistical simulation, simulating the repeated measures design. Assumptions included ICC of 0.3.||||0.341
72363601|NCT03367793|144238542|OTHER||least square means|0.31|||||TWO_SIDED|95.0|0.26|0.36|||||Additional model based estimates for 2-month estimated least square means in binocular visual acuity (logMAR) for PFST.|||0.36|0.26|
72363602|NCT03367793|144238542|OTHER||least square means|0.33|||||TWO_SIDED|95.0|0.27|0.38|||||Additional model based estimates for 2-month estimated least square means in binocular visual acuity (logMAR) for VSX.|||0.38|0.27|
72363603|NCT03367793|144238542|OTHER||least square means|0.34|||||TWO_SIDED|95.0|0.28|0.39|||||Additional model based estimates for 2-month estimated least square means in binocular visual acuity (logMAR) for Clinical Refraction.|||0.39|0.28|
72430171|NCT02886728|144371735|SUPERIORITY||Least Squares Mean Difference|-0.55|STANDARD_ERROR_OF_MEAN|0.199||0.006|TWO_SIDED|95.0|-0.94|-0.16||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.16|-0.94|0.006
72430172|NCT02886728|144371736|SUPERIORITY||Least Squares Mean Difference|2.9|STANDARD_ERROR_OF_MEAN|0.56|<|0.001|TWO_SIDED|95.0|1.8|4.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||4.0|1.8|<0.001
72430173|NCT02886728|144371736|SUPERIORITY||Least Squares Mean Difference|1.6|STANDARD_ERROR_OF_MEAN|0.69||0.021|TWO_SIDED|95.0|0.2|2.9||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||2.9|0.2|0.021
72430174|NCT02886728|144371736|SUPERIORITY||Least Squares Mean Difference|0.8|STANDARD_ERROR_OF_MEAN|0.69||0.24|TWO_SIDED|95.0|-0.5|2.2||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||2.2|-0.5|0.24
72430175|NCT02886728|144371737|SUPERIORITY||Least Squares Mean Difference|1.3|STANDARD_ERROR_OF_MEAN|0.68||0.056|TWO_SIDED|95.0|0.0|2.6||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||2.6|-0.0|0.056
72430176|NCT02886728|144371737|SUPERIORITY||Least Squares Mean Difference|1.3|STANDARD_ERROR_OF_MEAN|0.82||0.1|TWO_SIDED|95.0|-0.3|3.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||3.0|-0.3|0.10
72430177|NCT02886728|144371737|SUPERIORITY||Least Squares Mean Difference|0.4|STANDARD_ERROR_OF_MEAN|0.83||0.67|TWO_SIDED|95.0|-1.3|2.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||2.0|-1.3|0.67
72430178|NCT02886728|144371738|SUPERIORITY||Least Squares Mean Difference|-0.65|STANDARD_ERROR_OF_MEAN|0.195|<|0.001|TWO_SIDED|95.0|-1.03|-0.27||MMRM model included treatment, visit, treatment by visit, stratification factors, campaign groups, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.27|-1.03|<0.001
72430179|NCT02886728|144371738|SUPERIORITY||Least Squares Mean Difference|-0.63|STANDARD_ERROR_OF_MEAN|0.236||0.008|TWO_SIDED|95.0|-1.09|-0.16||MMRM model included treatment, visit, treatment by visit, stratification factors, campaign groups, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.16|-1.09|0.008
72430180|NCT02886728|144371738|SUPERIORITY||Least Squares Mean Difference|-0.66|STANDARD_ERROR_OF_MEAN|0.242||0.006|TWO_SIDED|95.0|-1.14|-0.19||MMRM model included treatment, visit, treatment by visit, stratification factors, campaign groups, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.19|-1.14|0.006
72430181|NCT02886728|144371739|SUPERIORITY||Difference in Response Rates|25.5|||<|0.001|TWO_SIDED|95.0|19.3|31.7||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 2||31.7|19.3|<0.001
72430182|NCT02886728|144371739|SUPERIORITY||Difference in Response Rates|20.6|||<|0.001|TWO_SIDED|95.0|12.8|28.5||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 2||28.5|12.8|<0.001
72430183|NCT02886728|144371739|SUPERIORITY||Difference in Response Rates|22.9|||<|0.001|TWO_SIDED|95.0|15.1|30.8||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 2||30.8|15.1|<0.001
72430184|NCT02886728|144371739|SUPERIORITY||Difference in Response Rates|28.8|||<|0.001|TWO_SIDED|95.0|22.1|35.6||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 4||35.6|22.1|<0.001
72430185|NCT02886728|144371739|SUPERIORITY||Difference in Response Rates|22.1|||<|0.001|TWO_SIDED|95.0|13.6|30.7||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 4||30.7|13.6|<0.001
72430186|NCT02886728|144371739|SUPERIORITY||Difference in Response Rates|19.0|||<|0.001|TWO_SIDED|95.0|10.5|27.5||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 4||27.5|10.5|<0.001
72430187|NCT02886728|144371739|SUPERIORITY||Difference in Response Rates|17.3|||<|0.001|TWO_SIDED|95.0|10.8|23.8||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 12||23.8|10.8|<0.001
72430188|NCT02886728|144371739|SUPERIORITY||Difference in Response Rates|12.6||||0.002|TWO_SIDED|95.0|4.5|20.7||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 12||20.7|4.5|0.002
72430189|NCT02886728|144371739|SUPERIORITY||Difference in Response Rates|12.1||||0.002|TWO_SIDED|95.0|4.0|20.1||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 12||20.1|4.0|0.002
72430190|NCT02886728|144371739|SUPERIORITY||Difference in Response Rates|7.2||||0.016|TWO_SIDED|95.0|0.9|13.5||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 36||13.5|0.9|0.016
72430191|NCT02886728|144371739|SUPERIORITY||Difference in Response Rates|5.2||||0.18|TWO_SIDED|95.0|-2.7|13.0||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 36||13.0|-2.7|0.18
72430192|NCT02886728|144371739|SUPERIORITY||Difference in Response Rates|7.9||||0.03|TWO_SIDED|95.0|0.3|15.6||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 36||15.6|0.3|0.030
72430193|NCT02886728|144371739|SUPERIORITY||Difference in Response Rates|13.2|||<|0.001|TWO_SIDED|95.0|6.7|19.7||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 52||19.7|6.7|<0.001
72430194|NCT02886728|144371739|SUPERIORITY||Difference in Response Rates|11.7||||0.003|TWO_SIDED|95.0|3.7|19.6||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 52||19.6|3.7|0.003
72430195|NCT02886728|144371739|SUPERIORITY||Difference in Response Rates|13.0|||<|0.001|TWO_SIDED|95.0|5.1|20.8||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 52||20.8|5.1|<0.001
72430196|NCT02886728|144371740|SUPERIORITY||Difference in Response Rates|10.1|||<|0.001|TWO_SIDED|95.0|6.2|13.9||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 2||13.9|6.2|<0.001
72430197|NCT02886728|144371740|SUPERIORITY||Difference in Response Rates|6.3||||0.001|TWO_SIDED|95.0|1.7|10.9||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 2||10.9|1.7|0.001
72430198|NCT02886728|144371740|SUPERIORITY||Difference in Response Rates|13.3|||<|0.001|TWO_SIDED|95.0|7.7|18.9||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 2||18.9|7.7|<0.001
72430199|NCT02886728|144371740|SUPERIORITY||Difference in Response Rates|20.0|||<|0.001|TWO_SIDED|95.0|14.5|25.4||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 4||25.4|14.5|<0.001
72430200|NCT02886728|144371740|SUPERIORITY||Difference in Response Rates|11.4|||<|0.001|TWO_SIDED|95.0|4.8|18.0||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 4||18.0|4.8|<0.001
72430201|NCT02886728|144371740|SUPERIORITY||Difference in Response Rates|16.3|||<|0.001|TWO_SIDED|95.0|9.4|23.2||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 4||23.2|9.4|<0.001
72430202|NCT02886728|144371740|SUPERIORITY||Difference in Response Rates|24.8|||<|0.001|TWO_SIDED|95.0|18.1|31.5||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 12||31.5|18.1|<0.001
72430203|NCT02886728|144371740|SUPERIORITY||Difference in Response Rates|16.1|||<|0.001|TWO_SIDED|95.0|7.7|24.5||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 12||24.5|7.7|<0.001
72430204|NCT02886728|144371740|SUPERIORITY||Difference in Response Rates|17.3|||<|0.001|TWO_SIDED|95.0|9.0|25.7||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 12||25.7|9.0|<0.001
72430205|NCT02886728|144371740|SUPERIORITY||Difference in Response Rates|15.9|||<|0.001|TWO_SIDED|95.0|8.9|22.8||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 24||22.8|8.9|<0.001
72430206|NCT02886728|144371740|SUPERIORITY||Difference in Response Rates|11.3||||0.006|TWO_SIDED|95.0|2.7|20.0||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 24||20.0|2.7|0.006
72430207|NCT02886728|144371740|SUPERIORITY||Difference in Response Rates|12.4||||0.002|TWO_SIDED|95.0|3.9|21.0||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 24||21.0|3.9|0.002
72430208|NCT02886728|144371740|SUPERIORITY||Difference in Response Rates|12.0|||<|0.001|TWO_SIDED|95.0|5.1|19.0||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 36||19.0|5.1|<0.001
72430209|NCT02886728|144371740|SUPERIORITY||Difference in Response Rates|7.0||||0.09|TWO_SIDED|95.0|-1.7|15.7||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 36||15.7|-1.7|0.090
72430210|NCT02886728|144371740|SUPERIORITY||Difference in Response Rates|10.0||||0.014|TWO_SIDED|95.0|1.4|18.6||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 36||18.6|1.4|0.014
72430211|NCT02886728|144371740|SUPERIORITY||Difference in Response Rates|13.9|||<|0.001|TWO_SIDED|95.0|7.0|20.9||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 52||20.9|7.0|<0.001
72430212|NCT02886728|144371740|SUPERIORITY||Difference in Response Rates|11.1||||0.008|TWO_SIDED|95.0|2.5|19.7||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 52||19.7|2.5|0.008
72430213|NCT02886728|144371740|SUPERIORITY||Difference in Response Rates|13.1||||0.001|TWO_SIDED|95.0|4.6|21.6||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 52||21.6|4.6|0.001
72430214|NCT02886728|144371741|SUPERIORITY||Difference in Response Rates|2.4||||0.018|TWO_SIDED|95.0|0.3|4.5||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 2||4.5|0.3|0.018
72430215|NCT02886728|144371741|SUPERIORITY||Difference in Response Rates|1.2||||0.17|TWO_SIDED|95.0|-1.2|3.6||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 2||3.6|-1.2|0.17
72430216|NCT02886728|144371741|SUPERIORITY||Difference in Response Rates|3.6||||0.004|TWO_SIDED|95.0|0.3|6.8||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 2||6.8|0.3|0.004
72430217|NCT02886728|144371741|SUPERIORITY||Difference in Response Rates|9.1|||<|0.001|TWO_SIDED|95.0|5.2|13.1||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 4||13.1|5.2|<0.001
72363604|NCT03367793|144238543|OTHER||f statistic|0.93||||0.41|TWO_SIDED|||||The threshold for statistical significance was 0.05.|f test|||It was calculated that 29 participants randomized in a 3x3 within-subject crossover design (repeated measures) achieves at least 89% power to detect an effect size of 0.25. Sample size was determined by a 2-sided f-test (alpha = 0.05) of the overall treatment effect based on a statistical simulation, simulating the repeated measures design. Assumptions included ICC of 0.3.||||0.410
72363605|NCT03367793|144238543|OTHER||least square means|0.35|||||TWO_SIDED|95.0|0.28|0.41|||||Additional model based estimates for initial visit estimated least square means in binocular visual acuity (logMAR) for PFST.|||0.41|0.28|
72363606|NCT03367793|144238543|OTHER||least square means|0.33|||||TWO_SIDED|95.0|0.26|0.39|||||Additional model based estimates for initial visit estimated least square means in binocular visual acuity (logMAR) for VSX.|||0.39|0.26|
72363607|NCT03367793|144238543|OTHER||least square means|0.34|||||TWO_SIDED|95.0|0.28|0.41|||||Additional model based estimates for initial visit estimated least square means in binocular visual acuity (logMAR) for Clinical Refraction.|||0.41|0.28|
72363608|NCT03367793|144238544|OTHER||f statistic|1.09||||0.351|TWO_SIDED|||||The threshold for statistical significance was alpha=0.05.|f test|||It was calculated that 29 participants randomized in a 3x3 within-subject crossover design (repeated measures) achieves at least 89% power to detect an effect size of 0.25. Sample size was determined by a 2-sided f-test (alpha = 0.05) of the overall treatment effect based on a statistical simulation, simulating the repeated measures design. Assumptions included ICC of 0.3.||||0.351
72363609|NCT03367793|144238544|OTHER||least square means|11.0|||||TWO_SIDED|95.0|9.3|12.7|||||Additional model based estimates for two-month wear time estimated least square means in spectacle wear-time (Hours) for PFST.|||12.7|9.3|
72363610|NCT03367793|144238544|OTHER||least square means|10.9|||||TWO_SIDED|95.0|9.2|12.6|||||Additional model based estimates for two-month wear time estimated least square means in spectacle wear-time (Hours) for VSX.|||12.6|9.2|
72363611|NCT03367793|144238544|OTHER||least square means|11.2|||||TWO_SIDED|95.0|9.5|12.9|||||Additional model based estimates for two-month wear time estimated least square means in spectacle wear-time (Hours) for Clinical Refraction.|||12.9|9.5|
72363612|NCT03367793|144238545|OTHER||f statistic|0.58||||0.562|TWO_SIDED||||||Mixed Models Analysis|||It was calculated that a sample size of n=28 yields 82% power to detect a difference of 0.4 in proportion of satisfaction (binary outcome of scores of '4' or '5' versus '1 to 3') in comparing two metrics using a two sided McNemar's test (alpha = 0.025 to account for pairwise testing).||||0.562
72430218|NCT02886728|144371741|SUPERIORITY||Difference in Response Rates|2.4||||0.18|TWO_SIDED|95.0|-1.7|6.6||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 4||6.6|-1.7|0.18
72430219|NCT02886728|144371741|SUPERIORITY||Difference in Response Rates|7.6|||<|0.001|TWO_SIDED|95.0|2.5|12.6||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 4||12.6|2.5|<0.001
72363613|NCT03367793|144238545|OTHER||proportion|0.967|||||TWO_SIDED||||||||Additional estimates of proportion of 2-month satisfactory responses (binary) for Spectacle Assessment Survey Item 1 for PFST.|||||
72363614|NCT03367793|144238545|OTHER||proportion|0.933|||||TWO_SIDED||||||||Additional estimates of proportion of 2-month satisfactory responses (binary) for Spectacle Assessment Survey Item 1 for VSX.|||||
72363615|NCT03367793|144238545|OTHER||proportion|0.897|||||TWO_SIDED||||||||Additional estimates of proportion of 2-month satisfactory responses (binary) for Spectacle Assessment Survey Item 1 for Clinical Refraction.|||||
72430220|NCT02886728|144371741|SUPERIORITY||Difference in Response Rates|19.7|||<|0.001|TWO_SIDED|95.0|13.9|25.5||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 12||25.5|13.9|<0.001
72430221|NCT02886728|144371741|SUPERIORITY||Difference in Response Rates|13.8|||<|0.001|TWO_SIDED|95.0|6.6|21.1||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 12||21.1|6.6|<0.001
72430222|NCT02886728|144371741|SUPERIORITY||Difference in Response Rates|15.8|||<|0.001|TWO_SIDED|95.0|8.5|23.1||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 12||23.1|8.5|<0.001
72430223|NCT02886728|144371741|SUPERIORITY||Difference in Response Rates|17.8|||<|0.001|TWO_SIDED|95.0|11.2|24.4||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 24||24.4|11.2|<0.001
72430224|NCT02886728|144371741|SUPERIORITY||Difference in Response Rates|14.1|||<|0.001|TWO_SIDED|95.0|5.9|22.4||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 24||22.4|5.9|<0.001
72430225|NCT02886728|144371741|SUPERIORITY||Difference in Response Rates|14.0|||<|0.001|TWO_SIDED|95.0|5.8|22.2||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 24||22.2|5.8|<0.001
72430226|NCT02886728|144371741|SUPERIORITY||Difference in Response Rates|13.7|||<|0.001|TWO_SIDED|95.0|6.9|20.5||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 36||20.5|6.9|<0.001
72430227|NCT02886728|144371741|SUPERIORITY||Difference in Response Rates|5.0||||0.2|TWO_SIDED|95.0|-3.3|13.3||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 36||13.3|-3.3|0.20
72430228|NCT02886728|144371741|SUPERIORITY||Difference in Response Rates|7.3||||0.056|TWO_SIDED|95.0|-1.0|15.7||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 36||15.7|-1.0|0.056
72430229|NCT02886728|144371741|SUPERIORITY||Difference in Response Rates|18.0|||<|0.001|TWO_SIDED|95.0|11.3|24.8||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 52||24.8|11.3|<0.001
72430230|NCT02886728|144371741|SUPERIORITY||Difference in Response Rates|10.3||||0.01|TWO_SIDED|95.0|1.9|18.6||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 52||18.6|1.9|0.010
72430231|NCT02886728|144371741|SUPERIORITY||Difference in Response Rates|15.4|||<|0.001|TWO_SIDED|95.0|7.0|23.8||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 52||23.8|7.0|<0.001
72430232|NCT02886728|144371742|SUPERIORITY||Least Squares Mean Difference|-0.23|STANDARD_ERROR_OF_MEAN|0.031|<|0.001|TWO_SIDED|95.0|-0.29|-0.17||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and subjects being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.17|-0.29|<0.001
72430233|NCT02886728|144371742|SUPERIORITY||Least Squares Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.038|<|0.001|TWO_SIDED|95.0|-0.28|-0.13||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and subjects being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.13|-0.28|<0.001
72430234|NCT02886728|144371742|SUPERIORITY||Least Squares Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.038|<|0.001|TWO_SIDED|95.0|-0.24|-0.09||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and subjects being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.09|-0.24|<0.001
72430235|NCT02886728|144371742|SUPERIORITY||Least Squares Mean Difference|-0.29|STANDARD_ERROR_OF_MEAN|0.035|<|0.001|TWO_SIDED|95.0|-0.35|-0.22||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and subjects being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.22|-0.35|<0.001
72430236|NCT02886728|144371742|SUPERIORITY||Least Squares Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.043|<|0.001|TWO_SIDED|95.0|-0.23|-0.06||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and subjects being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.06|-0.23|<0.001
72430237|NCT02886728|144371742|SUPERIORITY||Least Squares Mean Difference|-0.21|STANDARD_ERROR_OF_MEAN|0.042|<|0.001|TWO_SIDED|95.0|-0.29|-0.12||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and subjects being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.12|-0.29|<0.001
72430238|NCT02886728|144371742|SUPERIORITY||Least Squares Mean Difference|-0.28|STANDARD_ERROR_OF_MEAN|0.039|<|0.001|TWO_SIDED|95.0|-0.35|-0.2||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and subjects being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.20|-0.35|<0.001
72430239|NCT02886728|144371742|SUPERIORITY||Least Squares Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.048|<|0.001|TWO_SIDED|95.0|-0.28|-0.09||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and subjects being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.09|-0.28|<0.001
72430240|NCT02886728|144371742|SUPERIORITY||Least Squares Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.048|<|0.001|TWO_SIDED|95.0|-0.26|-0.07||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and subjects being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.07|-0.26|<0.001
72430241|NCT02886728|144371742|SUPERIORITY||Least Squares Mean Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.043||0.002|TWO_SIDED|95.0|-0.22|-0.05||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and subjects being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.05|-0.22|0.002
72430242|NCT02886728|144371742|SUPERIORITY||Least Squares Mean Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.052||0.23|TWO_SIDED|95.0|-0.17|0.04||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and subjects being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||0.04|-0.17|0.23
72430243|NCT02886728|144371742|SUPERIORITY||Least Squares Mean Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.052||0.24|TWO_SIDED|95.0|-0.16|0.04||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and subjects being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||0.04|-0.16|0.24
72430244|NCT02886728|144371742|SUPERIORITY||Least Squares Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.045|<|0.001|TWO_SIDED|95.0|-0.25|-0.08||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and subjects being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.08|-0.25|<0.001
72430245|NCT02886728|144371742|SUPERIORITY||Least Squares Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.054||0.077|TWO_SIDED|95.0|-0.2|0.01||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and subjects being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||0.01|-0.20|0.077
72430246|NCT02886728|144371742|SUPERIORITY||Least Squares Mean Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.054||0.039|TWO_SIDED|95.0|-0.22|-0.01||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and subjects being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.01|-0.22|0.039
72430247|NCT02886728|144371743|SUPERIORITY||Least Squares Mean Difference|-5.0|STANDARD_ERROR_OF_MEAN|0.8|<|0.001|TWO_SIDED|95.0|-6.0|-3.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-3.0|-6.0|<0.001
72430248|NCT02886728|144371743|SUPERIORITY||Least Squares Mean Difference|-4.0|STANDARD_ERROR_OF_MEAN|0.9|<|0.001|TWO_SIDED|95.0|-6.0|-2.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-2.0|-6.0|<0.001
72430249|NCT02886728|144371743|SUPERIORITY||Least Squares Mean Difference|-5.0|STANDARD_ERROR_OF_MEAN|0.9|<|0.001|TWO_SIDED|95.0|-7.0|-3.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-3.0|-7.0|<0.001
72430250|NCT02886728|144371743|SUPERIORITY||Least Squares Mean Difference|-5.0|STANDARD_ERROR_OF_MEAN|0.7|<|0.001|TWO_SIDED|95.0|-7.0|-4.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-4.0|-7.0|<0.001
72430251|NCT02886728|144371743|SUPERIORITY||Least Squares Mean Difference|-4.0|STANDARD_ERROR_OF_MEAN|0.9|<|0.001|TWO_SIDED|95.0|-6.0|-3.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-3.0|-6.0|<0.001
72430252|NCT02886728|144371743|SUPERIORITY||Least Squares Mean Difference|-5.0|STANDARD_ERROR_OF_MEAN|0.9|<|0.001|TWO_SIDED|95.0|-7.0|-3.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-3.0|-7.0|<0.001
72430253|NCT02886728|144371743|SUPERIORITY||Least Squares Mean Difference|-3.0|STANDARD_ERROR_OF_MEAN|0.7|<|0.001|TWO_SIDED|95.0|-5.0|-2.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-2.0|-5.0|<0.001
72430254|NCT02886728|144371743|SUPERIORITY||Least Squares Mean Difference|-3.0|STANDARD_ERROR_OF_MEAN|0.8|<|0.001|TWO_SIDED|95.0|-5.0|-2.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-2.0|-5.0|<0.001
72430255|NCT02886728|144371743|SUPERIORITY||Least Squares Mean Difference|-4.0|STANDARD_ERROR_OF_MEAN|0.8|<|0.001|TWO_SIDED|95.0|-6.0|-2.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-2.0|-6.0|<0.001
72430256|NCT02886728|144371743|SUPERIORITY||Least Squares Mean Difference|-2.0|STANDARD_ERROR_OF_MEAN|0.5|<|0.001|TWO_SIDED|95.0|-3.0|-1.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-1.0|-3.0|<0.001
72430257|NCT02886728|144371743|SUPERIORITY||Least Squares Mean Difference|-2.0|STANDARD_ERROR_OF_MEAN|0.6||0.005|TWO_SIDED|95.0|-3.0|-1.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-1.0|-3.0|0.005
72430258|NCT02886728|144371743|SUPERIORITY||Least Squares Mean Difference|-3.0|STANDARD_ERROR_OF_MEAN|0.6|<|0.001|TWO_SIDED|95.0|-4.0|-1.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-1.0|-4.0|<0.001
72430259|NCT02886728|144371743|SUPERIORITY||Least Squares Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.5||0.063|TWO_SIDED|95.0|-2.0|0.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||0.0|-2.0|0.063
72430260|NCT02886728|144371743|SUPERIORITY||Least Squares Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.6||0.64|TWO_SIDED|95.0|-1.0|1.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||1.0|-1.0|0.64
72430261|NCT02886728|144371743|SUPERIORITY||Least Squares Mean Difference|-2.0|STANDARD_ERROR_OF_MEAN|0.6|<|0.001|TWO_SIDED|95.0|-3.0|-1.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-1.0|-3.0|<0.001
72430262|NCT02886728|144371743|SUPERIORITY||Least Squares Mean Difference|-2.0|STANDARD_ERROR_OF_MEAN|0.5|<|0.001|TWO_SIDED|95.0|-3.0|-1.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-1.0|-3.0|<0.001
72430263|NCT02886728|144371743|SUPERIORITY||Least Squares Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.6||0.095|TWO_SIDED|95.0|-2.0|0.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||0.0|-2.0|0.095
72430264|NCT02886728|144371743|SUPERIORITY||Least Squares Mean Difference|-2.0|STANDARD_ERROR_OF_MEAN|0.6|<|0.001|TWO_SIDED|95.0|-3.0|-1.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-1.0|-3.0|<0.001
72430265|NCT02886728|144371744|SUPERIORITY||Least Squares Mean Difference|-2.0|STANDARD_ERROR_OF_MEAN|0.6|<|0.001|TWO_SIDED|95.0|-3.0|-1.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-1.0|-3.0|<0.001
72430266|NCT02886728|144371744|SUPERIORITY||Least Squares Mean Difference|-2.0|STANDARD_ERROR_OF_MEAN|0.7||0.002|TWO_SIDED|95.0|-3.0|-1.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-1.0|-3.0|0.002
72430267|NCT02886728|144371744|SUPERIORITY||Least Squares Mean Difference|-3.0|STANDARD_ERROR_OF_MEAN|0.7|<|0.001|TWO_SIDED|95.0|-4.0|-1.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-1.0|-4.0|<0.001
72430268|NCT02886728|144371744|SUPERIORITY||Least Squares Mean Difference|-3.0|STANDARD_ERROR_OF_MEAN|0.5|<|0.001|TWO_SIDED|95.0|-4.0|-2.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|Mixed effects model for repeated measure|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-2.0|-4.0|<0.001
72430269|NCT02886728|144371744|SUPERIORITY||Least Squares Mean Difference|-3.0|STANDARD_ERROR_OF_MEAN|0.6|<|0.001|TWO_SIDED|95.0|-4.0|-1.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-1.0|-4.0|<0.001
72430270|NCT02886728|144371744|SUPERIORITY||Least Squares Mean Difference|-3.0|STANDARD_ERROR_OF_MEAN|0.6|<|0.001|TWO_SIDED|95.0|-4.0|-1.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-1.0|-4.0|<0.001
72430271|NCT02886728|144371744|SUPERIORITY||Least Squares Mean Difference|-2.0|STANDARD_ERROR_OF_MEAN|0.4|<|0.001|TWO_SIDED|95.0|-3.0|-2.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-2.0|-3.0|<0.001
72430272|NCT02886728|144371744|SUPERIORITY||Least Squares Mean Difference|-2.0|STANDARD_ERROR_OF_MEAN|0.5|<|0.001|TWO_SIDED|95.0|-3.0|-1.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-1.0|-3.0|<0.001
72430273|NCT02886728|144371744|SUPERIORITY||Least Squares Mean Difference|-3.0|STANDARD_ERROR_OF_MEAN|0.5|<|0.001|TWO_SIDED|95.0|-4.0|-2.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-2.0|-4.0|<0.001
72430274|NCT02886728|144371744|SUPERIORITY||Least Squares Mean Difference|-2.0|STANDARD_ERROR_OF_MEAN|0.3|<|0.001|TWO_SIDED|95.0|-2.0|-1.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-1.0|-2.0|<0.001
72430275|NCT02886728|144371744|SUPERIORITY||Least Squares Mean Difference|-2.0|STANDARD_ERROR_OF_MEAN|0.4|<|0.001|TWO_SIDED|95.0|-2.0|-1.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-1.0|-2.0|<0.001
72363616|NCT03367793|144238546|OTHER||||||>|0.99|||||||Mixed Models Analysis|||It was calculated that a sample size of n=28 yields 82% power to detect a difference of 0.4 in proportion of satisfaction (binary outcome of scores of '4' or '5' versus '1 to 3') in comparing two metrics using a two sided McNemar's test (alpha = 0.025 to account for pairwise testing).||||>0.99
72430276|NCT02886728|144371744|SUPERIORITY||Least Squares Mean Difference|-2.0|STANDARD_ERROR_OF_MEAN|0.4|<|0.001|TWO_SIDED|95.0|-3.0|-1.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-1.0|-3.0|<0.001
72430277|NCT02886728|144371744|SUPERIORITY||Least Squares Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|-1.0|0.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.0|-1.0|<0.001
72430278|NCT02886728|144371744|SUPERIORITY||Least Squares Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.3||0.12|TWO_SIDED|95.0|-1.0|0.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||0.0|-1.0|0.12
72430279|NCT02886728|144371744|SUPERIORITY||Least Squares Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.3||0.019|TWO_SIDED|95.0|-1.0|0.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.0|-1.0|0.019
72430280|NCT02886728|144371744|SUPERIORITY||Least Squares Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|-2.0|-1.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-1.0|-2.0|<0.001
72430281|NCT02886728|144371744|SUPERIORITY||Least Squares Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.3||0.032|TWO_SIDED|95.0|-1.0|0.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.0|-1.0|0.032
72430282|NCT02886728|144371744|SUPERIORITY||Least Squares Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.3|<|0.001|TWO_SIDED|95.0|-2.0|0.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.0|-2.0|<0.001
72430283|NCT02886728|144371745|SUPERIORITY||Least Squares Mean Difference|-11.0|STANDARD_ERROR_OF_MEAN|1.3|<|0.001|TWO_SIDED|95.0|-13.0|-8.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-8.0|-13.0|<0.001
72430284|NCT02886728|144371745|SUPERIORITY||Least Squares Mean Difference|-7.0|STANDARD_ERROR_OF_MEAN|1.6|<|0.001|TWO_SIDED|95.0|-10.0|-4.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-4.0|-10.0|<0.001
72430285|NCT02886728|144371745|SUPERIORITY||Least Squares Mean Difference|-7.0|STANDARD_ERROR_OF_MEAN|1.6|<|0.001|TWO_SIDED|95.0|-10.0|-3.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-3.0|-10.0|<0.001
72430286|NCT02886728|144371745|SUPERIORITY||Least Squares Mean Difference|-12.0|STANDARD_ERROR_OF_MEAN|1.5|<|0.001|TWO_SIDED|95.0|-15.0|-10.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-10.0|-15.0|<0.001
72430287|NCT02886728|144371745|SUPERIORITY||Least Squares Mean Difference|-6.0|STANDARD_ERROR_OF_MEAN|1.8||0.001|TWO_SIDED|95.0|-10.0|-2.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-2.0|-10.0|0.001
72430288|NCT02886728|144371745|SUPERIORITY||Least Squares Mean Difference|-7.0|STANDARD_ERROR_OF_MEAN|1.8|<|0.001|TWO_SIDED|95.0|-11.0|-4.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-4.0|-11.0|<0.001
72430289|NCT02886728|144371745|SUPERIORITY||Least Squares Mean Difference|-12.0|STANDARD_ERROR_OF_MEAN|1.6|<|0.001|TWO_SIDED|95.0|-15.0|-9.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-9.0|-15.0|<0.001
72430290|NCT02886728|144371745|SUPERIORITY||Least Squares Mean Difference|-5.0|STANDARD_ERROR_OF_MEAN|2.0||0.009|TWO_SIDED|95.0|-9.0|-1.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-1.0|-9.0|0.009
72430291|NCT02886728|144371745|SUPERIORITY||Least Squares Mean Difference|-6.0|STANDARD_ERROR_OF_MEAN|2.0||0.003|TWO_SIDED|95.0|-10.0|-2.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-2.0|-10.0|0.003
72430292|NCT02886728|144371745|SUPERIORITY||Least Squares Mean Difference|-9.0|STANDARD_ERROR_OF_MEAN|1.6|<|0.001|TWO_SIDED|95.0|-13.0|-6.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-6.0|-13.0|<0.001
72430293|NCT02886728|144371745|SUPERIORITY||Least Squares Mean Difference|-3.0|STANDARD_ERROR_OF_MEAN|2.0||0.11|TWO_SIDED|95.0|-7.0|1.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||1.0|-7.0|0.11
72430294|NCT02886728|144371745|SUPERIORITY||Least Squares Mean Difference|-4.0|STANDARD_ERROR_OF_MEAN|2.0||0.066|TWO_SIDED|95.0|-8.0|0.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||0.0|-8.0|0.066
72430295|NCT02886728|144371745|SUPERIORITY||Least Squares Mean Difference|-7.0|STANDARD_ERROR_OF_MEAN|1.7|<|0.001|TWO_SIDED|95.0|-11.0|-4.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-4.0|-11.0|<0.001
72430296|NCT02886728|144371745|SUPERIORITY||Least Squares Mean Difference|-2.0|STANDARD_ERROR_OF_MEAN|2.1||0.4|TWO_SIDED|95.0|-6.0|2.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||2.0|-6.0|0.40
72430297|NCT02886728|144371745|SUPERIORITY||Least Squares Mean Difference|-2.0|STANDARD_ERROR_OF_MEAN|2.1||0.24|TWO_SIDED|95.0|-6.0|2.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||2.0|-6.0|0.24
72430298|NCT02886728|144371745|SUPERIORITY||Least Squares Mean Difference|-9.0|STANDARD_ERROR_OF_MEAN|1.7|<|0.001|TWO_SIDED|95.0|-12.0|-5.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-5.0|-12.0|<0.001
72430299|NCT02886728|144371745|SUPERIORITY||Least Squares Mean Difference|-3.0|STANDARD_ERROR_OF_MEAN|2.1||0.17|TWO_SIDED|95.0|-7.0|1.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||1.0|-7.0|0.17
72430300|NCT02886728|144371745|SUPERIORITY||Least Squares Mean Difference|-6.0|STANDARD_ERROR_OF_MEAN|2.1||0.008|TWO_SIDED|95.0|-10.0|-1.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-1.0|-10.0|0.008
72430301|NCT02886728|144371746|SUPERIORITY||Least Squares Mean Difference|-9.0|STANDARD_ERROR_OF_MEAN|1.3|<|0.001|TWO_SIDED|95.0|-12.0|-6.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-6.0|-12.0|<0.001
72430302|NCT02886728|144371746|SUPERIORITY||Least Squares Mean Difference|-6.0|STANDARD_ERROR_OF_MEAN|1.6|<|0.001|TWO_SIDED|95.0|-9.0|-2.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-2.0|-9.0|<0.001
72430303|NCT02886728|144371746|SUPERIORITY||Least Squares Mean Difference|-8.0|STANDARD_ERROR_OF_MEAN|1.6|<|0.001|TWO_SIDED|95.0|-11.0|-5.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-5.0|-11.0|<0.001
72430304|NCT02886728|144371746|SUPERIORITY||Least Squares Mean Difference|-11.0|STANDARD_ERROR_OF_MEAN|1.4|<|0.001|TWO_SIDED|95.0|-13.0|-8.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-8.0|-13.0|<0.001
72430305|NCT02886728|144371746|SUPERIORITY||Least Squares Mean Difference|-8.0|STANDARD_ERROR_OF_MEAN|1.7|<|0.001|TWO_SIDED|95.0|-11.0|-4.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-4.0|-11.0|<0.001
72430306|NCT02886728|144371746|SUPERIORITY||Least Squares Mean Difference|-8.0|STANDARD_ERROR_OF_MEAN|1.7|<|0.001|TWO_SIDED|95.0|-11.0|-5.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-5.0|-11.0|<0.001
72430307|NCT02886728|144371746|SUPERIORITY||Least Squares Mean Difference|-9.0|STANDARD_ERROR_OF_MEAN|1.3|<|0.001|TWO_SIDED|95.0|-12.0|-7.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-7.0|-12.0|<0.001
72430308|NCT02886728|144371746|SUPERIORITY||Least Squares Mean Difference|-6.0|STANDARD_ERROR_OF_MEAN|1.6|<|0.001|TWO_SIDED|95.0|-9.0|-2.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-2.0|-9.0|<0.001
72430309|NCT02886728|144371746|SUPERIORITY||Least Squares Mean Difference|-5.0|STANDARD_ERROR_OF_MEAN|1.6||0.001|TWO_SIDED|95.0|-8.0|-2.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-2.0|-8.0|0.001
72430310|NCT02886728|144371746|SUPERIORITY||Least Squares Mean Difference|-5.0|STANDARD_ERROR_OF_MEAN|1.2|<|0.001|TWO_SIDED|95.0|-8.0|-3.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-3.0|-8.0|<0.001
72430311|NCT02886728|144371746|SUPERIORITY||Least Squares Mean Difference|-4.0|STANDARD_ERROR_OF_MEAN|1.5||0.007|TWO_SIDED|95.0|-7.0|-1.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-1.0|-7.0|0.007
72430312|NCT02886728|144371746|SUPERIORITY||Least Squares Mean Difference|-3.0|STANDARD_ERROR_OF_MEAN|1.5||0.046|TWO_SIDED|95.0|-6.0|0.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.0|-6.0|0.046
72363617|NCT03367793|144238546|OTHER||proportion|0.967|||||TWO_SIDED||||||||Additional estimates of proportion of 2-month satisfactory responses (binary) for 2-month satisfactory responses (binary) for Spectacle Assessment Survey Item 2 for PFST.|||||
72430313|NCT02886728|144371746|SUPERIORITY||Least Squares Mean Difference|-4.0|STANDARD_ERROR_OF_MEAN|1.2||0.002|TWO_SIDED|95.0|-6.0|-1.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-1.0|-6.0|0.002
72430314|NCT02886728|144371746|SUPERIORITY||Least Squares Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|1.4||0.44|TWO_SIDED|95.0|-4.0|2.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||2.0|-4.0|0.44
72430315|NCT02886728|144371746|SUPERIORITY||Least Squares Mean Difference|-2.0|STANDARD_ERROR_OF_MEAN|1.4||0.21|TWO_SIDED|95.0|-5.0|1.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||1.0|-5.0|0.21
72430316|NCT02886728|144371746|SUPERIORITY||Least Squares Mean Difference|-5.0|STANDARD_ERROR_OF_MEAN|1.1|<|0.001|TWO_SIDED|95.0|-7.0|-3.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-3.0|-7.0|<0.001
72430317|NCT02886728|144371746|SUPERIORITY||Least Squares Mean Difference|-3.0|STANDARD_ERROR_OF_MEAN|1.4||0.029|TWO_SIDED|95.0|-6.0|0.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.0|-6.0|0.029
72430318|NCT02886728|144371746|SUPERIORITY||Least Squares Mean Difference|-4.0|STANDARD_ERROR_OF_MEAN|1.4||0.01|TWO_SIDED|95.0|-6.0|-1.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-1.0|-6.0|0.010
72363618|NCT03367793|144238546|OTHER||proportion|0.967|||||TWO_SIDED||||||||Additional estimates of proportion of 2-month satisfactory responses (binary) for Spectacle Assessment Survey Item 2 for VSX.|||||
72430319|NCT02886728|144371747|SUPERIORITY||Least Squares Mean Difference|-12.0|STANDARD_ERROR_OF_MEAN|1.4|<|0.001|TWO_SIDED|95.0|-15.0|-9.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-9.0|-15.0|<0.001
72430320|NCT02886728|144371747|SUPERIORITY||Least Squares Mean Difference|-8.0|STANDARD_ERROR_OF_MEAN|1.7|<|0.001|TWO_SIDED|95.0|-11.0|-5.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-5.0|-11.0|<0.001
72430321|NCT02886728|144371747|SUPERIORITY||Least Squares Mean Difference|-9.0|STANDARD_ERROR_OF_MEAN|1.7|<|0.001|TWO_SIDED|95.0|-13.0|-6.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-6.0|-13.0|<0.001
72430322|NCT02886728|144371747|SUPERIORITY||Least Squares Mean Difference|-13.0|STANDARD_ERROR_OF_MEAN|1.5|<|0.001|TWO_SIDED|95.0|-16.0|-10.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-10.0|-16.0|<0.001
72430323|NCT02886728|144371747|SUPERIORITY||Least Squares Mean Difference|-7.0|STANDARD_ERROR_OF_MEAN|1.9|<|0.001|TWO_SIDED|95.0|-11.0|-4.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-4.0|-11.0|<0.001
72363619|NCT03367793|144238546|OTHER||proportion|0.966|||||TWO_SIDED||||||||Additional estimates of proportion of 2-month satisfactory responses (binary) for Spectacle Assessment Survey Item 2 for Clinical Refraction.|||||
72430324|NCT02886728|144371747|SUPERIORITY||Least Squares Mean Difference|-9.0|STANDARD_ERROR_OF_MEAN|1.9|<|0.001|TWO_SIDED|95.0|-13.0|-6.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-6.0|-13.0|<0.001
72430325|NCT02886728|144371747|SUPERIORITY||Least Squares Mean Difference|-12.0|STANDARD_ERROR_OF_MEAN|1.7|<|0.001|TWO_SIDED|95.0|-15.0|-8.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-8.0|-15.0|<0.001
72430326|NCT02886728|144371747|SUPERIORITY||Least Squares Mean Difference|-5.0|STANDARD_ERROR_OF_MEAN|2.1||0.019|TWO_SIDED|95.0|-9.0|-1.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-1.0|-9.0|0.019
72430327|NCT02886728|144371747|SUPERIORITY||Least Squares Mean Difference|-6.0|STANDARD_ERROR_OF_MEAN|2.1||0.007|TWO_SIDED|95.0|-10.0|-2.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-2.0|-10.0|0.007
72430328|NCT02886728|144371747|SUPERIORITY||Least Squares Mean Difference|-9.0|STANDARD_ERROR_OF_MEAN|1.7|<|0.001|TWO_SIDED|95.0|-12.0|-5.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-5.0|-12.0|<0.001
72430329|NCT02886728|144371747|SUPERIORITY||Least Squares Mean Difference|-3.0|STANDARD_ERROR_OF_MEAN|2.0||0.13|TWO_SIDED|95.0|-7.0|1.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||1.0|-7.0|0.13
72430330|NCT02886728|144371747|SUPERIORITY||Least Squares Mean Difference|-4.0|STANDARD_ERROR_OF_MEAN|2.0||0.047|TWO_SIDED|95.0|-8.0|0.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.0|-8.0|0.047
72430331|NCT02886728|144371747|SUPERIORITY||Least Squares Mean Difference|-7.0|STANDARD_ERROR_OF_MEAN|1.8|<|0.001|TWO_SIDED|95.0|-11.0|-4.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-4.0|-11.0|<0.001
72430332|NCT02886728|144371747|SUPERIORITY||Least Squares Mean Difference|-2.0|STANDARD_ERROR_OF_MEAN|2.1||0.34|TWO_SIDED|95.0|-6.0|2.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||2.0|-6.0|0.34
72430333|NCT02886728|144371747|SUPERIORITY||Least Squares Mean Difference|-2.0|STANDARD_ERROR_OF_MEAN|2.1||0.46|TWO_SIDED|95.0|-6.0|3.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||3.0|-6.0|0.46
72430334|NCT02886728|144371747|SUPERIORITY||Least Squares Mean Difference|-9.0|STANDARD_ERROR_OF_MEAN|1.8|<|0.001|TWO_SIDED|95.0|-12.0|-5.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-5.0|-12.0|<0.001
72430335|NCT02886728|144371747|SUPERIORITY||Least Squares Mean Difference|-5.0|STANDARD_ERROR_OF_MEAN|2.2||0.03|TWO_SIDED|95.0|-9.0|0.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.0|-9.0|0.030
72430336|NCT02886728|144371747|SUPERIORITY||Least Squares Mean Difference|-7.0|STANDARD_ERROR_OF_MEAN|2.2|<|0.001|TWO_SIDED|95.0|-12.0|-3.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-3.0|-12.0|<0.001
72430337|NCT02886728|144371748|SUPERIORITY||Least Squares Mean Difference|-10.78|STANDARD_ERROR_OF_MEAN|0.983|<|0.001|TWO_SIDED|95.0|-12.71|-8.85||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-8.85|-12.71|<0.001
72430338|NCT02886728|144371748|SUPERIORITY||Least Squares Mean Difference|-8.76|STANDARD_ERROR_OF_MEAN|1.207|<|0.001|TWO_SIDED|95.0|-11.13|-6.39||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-6.39|-11.13|<0.001
72430339|NCT02886728|144371748|SUPERIORITY||Least Squares Mean Difference|-9.64|STANDARD_ERROR_OF_MEAN|1.2|<|0.001|TWO_SIDED|95.0|-12.0|-7.29||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-7.29|-12.00|<0.001
72430340|NCT02886728|144371748|SUPERIORITY||Least Squares Mean Difference|-9.92|STANDARD_ERROR_OF_MEAN|0.884|<|0.001|TWO_SIDED|95.0|-11.65|-8.19||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-8.19|-11.65|<0.001
72430341|NCT02886728|144371748|SUPERIORITY||Least Squares Mean Difference|-8.34|STANDARD_ERROR_OF_MEAN|1.086|<|0.001|TWO_SIDED|95.0|-10.47|-6.21||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-6.21|-10.47|<0.001
72430342|NCT02886728|144371748|SUPERIORITY||Least Squares Mean Difference|-7.33|STANDARD_ERROR_OF_MEAN|1.08|<|0.001|TWO_SIDED|95.0|-9.45|-5.21||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-5.21|-9.45|<0.001
72430343|NCT02886728|144371748|SUPERIORITY||Least Squares Mean Difference|-5.98|STANDARD_ERROR_OF_MEAN|0.808|<|0.001|TWO_SIDED|95.0|-7.56|-4.39||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-4.39|-7.56|<0.001
72430344|NCT02886728|144371748|SUPERIORITY||Least Squares Mean Difference|-4.21|STANDARD_ERROR_OF_MEAN|0.987|<|0.001|TWO_SIDED|95.0|-6.14|-2.27||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-2.27|-6.14|<0.001
72430345|NCT02886728|144371748|SUPERIORITY||Least Squares Mean Difference|-4.34|STANDARD_ERROR_OF_MEAN|0.993|<|0.001|TWO_SIDED|95.0|-6.29|-2.39||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-2.39|-6.29|<0.001
72430346|NCT02886728|144371748|SUPERIORITY||Least Squares Mean Difference|-5.27|STANDARD_ERROR_OF_MEAN|1.003|<|0.001|TWO_SIDED|95.0|-7.24|-3.31||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-3.31|-7.24|<0.001
72430347|NCT02886728|144371748|SUPERIORITY||Least Squares Mean Difference|-3.29|STANDARD_ERROR_OF_MEAN|1.222||0.007|TWO_SIDED|95.0|-5.68|-0.89||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.89|-5.68|0.007
72430348|NCT02886728|144371748|SUPERIORITY||Least Squares Mean Difference|-4.61|STANDARD_ERROR_OF_MEAN|1.229|<|0.001|TWO_SIDED|95.0|-7.02|-2.2||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-2.20|-7.02|<0.001
72430349|NCT02886728|144371748|SUPERIORITY||Least Squares Mean Difference|-3.44|STANDARD_ERROR_OF_MEAN|0.974|<|0.001|TWO_SIDED|95.0|-5.35|-1.53||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-1.53|-5.35|<0.001
72430350|NCT02886728|144371748|SUPERIORITY||Least Squares Mean Difference|-3.4|STANDARD_ERROR_OF_MEAN|1.18||0.004|TWO_SIDED|95.0|-5.72|-1.09||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-1.09|-5.72|0.004
72430351|NCT02886728|144371748|SUPERIORITY||Least Squares Mean Difference|-2.12|STANDARD_ERROR_OF_MEAN|1.18||0.072|TWO_SIDED|95.0|-4.44|0.19||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||0.19|-4.44|0.072
72430352|NCT02886728|144371748|SUPERIORITY||Least Squares Mean Difference|-4.79|STANDARD_ERROR_OF_MEAN|0.789|<|0.001|TWO_SIDED|95.0|-6.34|-3.24||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-3.24|-6.34|<0.001
72430353|NCT02886728|144371748|SUPERIORITY||Least Squares Mean Difference|-3.01|STANDARD_ERROR_OF_MEAN|0.957||0.002|TWO_SIDED|95.0|-4.88|-1.13||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-1.13|-4.88|0.002
72430354|NCT02886728|144371748|SUPERIORITY||Least Squares Mean Difference|-3.77|STANDARD_ERROR_OF_MEAN|0.957|<|0.001|TWO_SIDED|95.0|-5.65|-1.89||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-1.89|-5.65|<0.001
72430355|NCT02886728|144371749|SUPERIORITY||Difference in Response Rates|19.7|||<|0.001|TWO_SIDED|95.0|12.8|26.7||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 2||26.7|12.8|<0.001
72430356|NCT02886728|144371749|SUPERIORITY||Difference in Response Rates|16.3|||<|0.001|TWO_SIDED|95.0|7.6|25.0||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 2||25.0|7.6|<0.001
72430357|NCT02886728|144371749|SUPERIORITY||Difference in Response Rates|11.7||||0.004|TWO_SIDED|95.0|3.0|20.4||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 2||20.4|3.0|0.004
72430358|NCT02886728|144371749|SUPERIORITY||Difference in Response Rates|18.5|||<|0.001|TWO_SIDED|95.0|11.7|25.2||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 4||25.2|11.7|<0.001
72430359|NCT02886728|144371749|SUPERIORITY||Difference in Response Rates|7.1||||0.083|TWO_SIDED|95.0|-1.6|15.8||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 4||15.8|-1.6|0.083
72430360|NCT02886728|144371749|SUPERIORITY||Difference in Response Rates|14.7|||<|0.001|TWO_SIDED|95.0|6.4|23.1||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 4||23.1|6.4|<0.001
72430361|NCT02886728|144371749|SUPERIORITY||Difference in Response Rates|10.6|||<|0.001|TWO_SIDED|95.0|4.4|16.7||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 12||16.7|4.4|<0.001
72430362|NCT02886728|144371749|SUPERIORITY||Difference in Response Rates|4.7||||0.22|TWO_SIDED|95.0|-3.1|12.6||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 12||12.6|-3.1|0.22
72430363|NCT02886728|144371749|SUPERIORITY||Difference in Response Rates|4.3||||0.25|TWO_SIDED|95.0|-3.6|12.1||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 12||12.1|-3.6|0.25
72430364|NCT02886728|144371749|SUPERIORITY||Difference in Response Rates|2.7||||0.35|TWO_SIDED|95.0|-3.5|8.9||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 24||8.9|-3.5|0.35
72430365|NCT02886728|144371749|SUPERIORITY||Difference in Response Rates|4.6||||0.2|TWO_SIDED|95.0|-2.9|12.1||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 24||12.1|-2.9|0.20
72430366|NCT02886728|144371749|SUPERIORITY||Difference in Response Rates|3.1||||0.36|TWO_SIDED|95.0|-4.5|10.6||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 24||10.6|-4.5|0.36
72430367|NCT02886728|144371749|SUPERIORITY||Difference in Response Rates|6.3||||0.043|TWO_SIDED|95.0|-0.2|12.8||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 36||12.8|-0.2|0.043
72430368|NCT02886728|144371749|SUPERIORITY||Difference in Response Rates|9.4||||0.015|TWO_SIDED|95.0|1.6|17.2||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 36||17.2|1.6|0.015
72430369|NCT02886728|144371749|SUPERIORITY||Difference in Response Rates|6.5||||0.085|TWO_SIDED|95.0|-1.5|14.4||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 36||14.4|-1.5|0.085
72430370|NCT02886728|144371749|SUPERIORITY||Difference in Response Rates|9.9||||0.002|TWO_SIDED|95.0|3.2|16.6||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 52||16.6|3.2|0.002
72430371|NCT02886728|144371749|SUPERIORITY||Difference in Response Rates|10.5||||0.01|TWO_SIDED|95.0|2.3|18.7||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 52||18.7|2.3|0.010
72430372|NCT02886728|144371749|SUPERIORITY||Difference in Response Rates|9.6||||0.014|TWO_SIDED|95.0|1.4|17.8||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 52||17.8|1.4|0.014
72430373|NCT02886728|144371750|SUPERIORITY||Least Squares Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|95.0|-0.9|-0.6||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.6|-0.9|<0.001
72430374|NCT02886728|144371750|SUPERIORITY||Least Squares Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-0.7|-0.4||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.4|-0.7|<0.001
72430375|NCT02886728|144371750|SUPERIORITY||Least Squares Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-0.9|-0.6||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.6|-0.9|<0.001
72430376|NCT02886728|144371750|SUPERIORITY||Least Squares Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-1.1|-0.8||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.8|-1.1|<0.001
72430377|NCT02886728|144371750|SUPERIORITY||Least Squares Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.09|<|0.001|TWO_SIDED|95.0|-0.9|-0.5||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.5|-0.9|<0.001
72430378|NCT02886728|144371750|SUPERIORITY||Least Squares Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.09|<|0.001|TWO_SIDED|95.0|-1.0|-0.7||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.7|-1.0|<0.001
72430379|NCT02886728|144371750|SUPERIORITY||Least Squares Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-1.0|-0.7||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.7|-1.0|<0.001
72430380|NCT02886728|144371750|SUPERIORITY||Least Squares Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.8|-0.4||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.4|-0.8|<0.001
72430381|NCT02886728|144371750|SUPERIORITY||Least Squares Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.9|-0.5||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.5|-0.9|<0.001
72363620|NCT03367793|144238547|OTHER||||||>|0.99|||||||Mixed Models Analysis|||It was calculated that a sample size of n=28 yields 82% power to detect a difference of 0.4 in proportion of satisfaction (binary outcome of scores of '4' or '5' versus '1 to 3') in comparing two metrics using a two sided McNemar's test (alpha = 0.025 to account for pairwise testing).||||>0.99
72363621|NCT03367793|144238547|OTHER||proportion|0.967|||||TWO_SIDED||||||||Additional estimates of proportion of 2-month satisfactory responses (binary) for Spectacle Assessment Survey Item 3 for PFST.|||||
72363622|NCT03367793|144238547|OTHER||proportion|0.967|||||TWO_SIDED||||||||Additional estimates of proportion of 2-month satisfactory responses (binary) for Spectacle Assessment Survey Item 3 for VSX.|||||
72363623|NCT03367793|144238547|OTHER||proportion|0.966|||||TWO_SIDED||||||||Additional estimates of proportion of 2-month satisfactory responses (binary) for Spectacle Assessment Survey Item 3 for Clinical Refraction.|||||
72363624|NCT02435992|144238548|SUPERIORITY||Odds Ratio (OR)|3.586||||0.0001|TWO_SIDED|95.0|1.938|6.636|||Cochran-Mantel-Haenszel|||||6.636|1.938|0.0001
72363625|NCT02435992|144238549|SUPERIORITY||Odds Ratio (OR)|2.755||||0.0001|TWO_SIDED|95.0|1.767|4.294|||Cochran-Mantel-Haenszel|||||4.294|1.767|0.0001
72368792|NCT00125164|144247302|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|2.83|STANDARD_ERROR_OF_MEAN|0.29|<|0.0001||95.0|2.26|3.39||The two-sided p-values for the comparisons are adjusted for multiple comparisons using Dunnett's method.|ANCOVA|||The analysis compares each of the 80 and 120 µg/kg BID groups with the untreated control group using analysis of covariance (ANCOVA), where the covariates are the baseline height SD score stratum used in the randomization, the pretreatment height velocity, the baseline bone age, the baseline chronological age, and sex.||3.39|2.26|<0.0001
72368793|NCT00125164|144247302|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.01|STANDARD_ERROR_OF_MEAN|0.25||0.0002||95.0|0.5|1.51|||ANCOVA|||The analysis compares the 80 and 120 µg/kg BID groups using analysis of covariance (ANCOVA), where the covariates are the baseline height SD score stratum used in the randomization, the pretreatment height velocity, the baseline bone age, the baseline chronological age, and sex.||1.51|0.50|0.0002
72368794|NCT00125164|144247303|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.37|STANDARD_ERROR_OF_MEAN|0.06|<|0.0001||95.0|0.25|0.5||The two-sided p-values for the comparisons are adjusted for multiple comparisons using Dunnett's method.|ANCOVA|||The analysis compares each of the 80 and 120 µg/kg BID groups with the untreated control group using analysis of covariance (ANCOVA), where the covariates are the baseline height SD score stratum used in the randomization, the pretreatment height velocity, the baseline bone age, the baseline chronological age, and sex.||0.50|0.25|<0.0001
72368795|NCT00125164|144247303|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.52|STANDARD_ERROR_OF_MEAN|0.06|<|0.0001||95.0|0.39|0.64||The two-sided p-values for the comparisons are adjusted for multiple comparisons using Dunnett's method.|ANCOVA|||The analysis compares each of the 80 and 120 µg/kg BID groups with the untreated control group using analysis of covariance (ANCOVA), where the covariates are the baseline height SD score stratum used in the randomization, the pretreatment height velocity, the baseline bone age, the baseline chronological age, and sex.||0.64|0.39|<0.0001
72368796|NCT00125164|144247303|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.15|STANDARD_ERROR_OF_MEAN|0.06||0.0071||95.0|0.04|0.26|||ANCOVA|||The analysis compares the 80 and 120 µg/kg BID groups using analysis of covariance (ANCOVA), where the covariates are the baseline height SD score stratum used in the randomization, the pretreatment height velocity, the baseline bone age, the baseline chronological age, and sex.||0.26|0.04|0.0071
72368797|NCT02637037|144247319|NON_INFERIORITY_OR_EQUIVALENCE|If the 90% CIs for both dapagliflozin and metformin geometric mean ratio of AUC is entirely contained within an 80.00% to 125.00% interval, it will be concluded the 2 manufacturing sites are bioequivalent.|Ratios of Geometric means|0.96|||||TWO_SIDED|90.0|0.93|0.99||||||Dapagliflozin: Statistical Assessment of Bioequivalence for Dapagliflozin following administration Dapagliflozin/Metformin XR 5/500 mg for Treatment A and B.||0.99|0.93|
72368798|NCT02637037|144247319|NON_INFERIORITY_OR_EQUIVALENCE|If the 90% CIs for both dapagliflozin and metformin geometric mean ratio of AUC is entirely contained within an 80.00% to 125.00% interval, it will be concluded the 2 manufacturing sites are bioequivalent.|Ratios of Geometric means|0.99|||||TWO_SIDED|90.0|0.96|1.01||||||Dapagliflozin: Statistical Assessment of Bioequivalence for Dapagliflozin following administration Dapagliflozin/Metformin XR 5/500 mg for Treatment C and D.||1.01|0.96|
72368799|NCT02637037|144247319|NON_INFERIORITY_OR_EQUIVALENCE|If the 90% CIs for both dapagliflozin and metformin geometric mean ratio of AUC is entirely contained within an 80.00% to 125.00% interval, it will be concluded the 2 manufacturing sites are bioequivalent.|Ratios of Geometric means|0.97|||||TWO_SIDED|90.0|0.94|1.0||||||Dapagliflozin: Statistical Assessment of Bioequivalence for Dapagliflozin following administration Dapagliflozin/Metformin XR 10/1000 mg for Treatment E and F.||1.00|0.94|
72368800|NCT02637037|144247319|NON_INFERIORITY_OR_EQUIVALENCE|If the 90% CIs for both dapagliflozin and metformin geometric mean ratio of AUC is entirely contained within an 80.00% to 125.00% interval, it will be concluded the 2 manufacturing sites are bioequivalent.|Ratios of Geometric means|0.98|||||TWO_SIDED|90.0|0.95|1.0||||||Dapagliflozin: Statistical Assessment of Bioequivalence for Dapagliflozin following administration Dapagliflozin/Metformin XR 10/1000 mg for Treatment G and H.||1.00|0.95|
72368801|NCT02637037|144247319|NON_INFERIORITY_OR_EQUIVALENCE|If the 90% CIs for both dapagliflozin and metformin geometric mean ratio of AUC is entirely contained within an 80.00% to 125.00% interval, it will be concluded the 2 manufacturing sites are bioequivalent.|Ratios of Geometric means|1.01|||||TWO_SIDED|90.0|0.96|1.06||||||Metformin: Statistical Assessment of Bioequivalence for Metformin following administration Dapagliflozin/Metformin XR 5/500 mg for Treatment A and B.||1.06|0.96|
72368802|NCT02637037|144247319|NON_INFERIORITY_OR_EQUIVALENCE|If the 90% CIs for both dapagliflozin and metformin geometric mean ratio of AUC is entirely contained within an 80.00% to 125.00% interval, it will be concluded the 2 manufacturing sites are bioequivalent.|Ratios of Geometric means|1.0|||||TWO_SIDED|90.0|0.93|1.07||||||Metformin: Statistical Assessment of Bioequivalence for Metformin following administration Dapagliflozin/Metformin XR 5/500 mg for Treatment C and D.||1.07|0.93|
72368803|NCT02637037|144247319|NON_INFERIORITY_OR_EQUIVALENCE|If the 90% CIs for both dapagliflozin and metformin geometric mean ratio of AUC is entirely contained within an 80.00% to 125.00% interval, it will be concluded the 2 manufacturing sites are bioequivalent.|Ratios of Geometric means|1.05|||||TWO_SIDED|90.0|0.99|1.11||||||Metformin: Statistical Assessment of Bioequivalence for Metformin following administration Dapagliflozin/Metformin XR 10/1000 mg for Treatment E and F.||1.11|0.99|
72363626|NCT01761877|144238560|OTHER|Mixed Models Analysis|||||<|0.05||||||A p value was calculated for change in breast density from baseline to 12 months separately for each study arm.|Mixed Models Analysis|||The study was designed to assess change in breast density using fat/water MRI after 12 months of sulindac intervention in postmenopausal breast cancer patients taking aromatase inhibitors for the treatment of estrogen receptor positive breast cancer. A non-randomized observation arm was included with the same eligibility criteria to assess change in breast density over 12 months using the fat/water MRI method of quantifying breast density. Change was examined separately for each arm.||||<0.05
72363627|NCT01761877|144238561|OTHER||||||<|0.05||||||A p value of \<0.05 was selected for change in each arm. The study did not include a direct comparison between the two arms.|Mixed Models Analysis|||||||<0.05
72363628|NCT01761877|144238562|OTHER||||||<|0.05|TWO_SIDED|95.0||||A p value of \<0.05 was selected for change in each arm. The study did not include a direct comparison between the two arms.|Mixed Models Analysis|||||||<0.05
72363629|NCT02224560|144238577|SUPERIORITY||Median Difference (Final Values)|-21.57||||0.0047|TWO_SIDED|95.0|-34.79|-6.67|||Wilcoxon rank-sum test||Calculated using the Hodges-Lehmann approach|||-6.67|-34.79|0.0047
72363630|NCT02224560|144238577|SUPERIORITY||Median Difference (Final Values)|-19.19||||0.0016|TWO_SIDED|95.0|-31.24|-7.69|||Wilcoxon rank-sum test||Calculated using the Hodges-Lehmann approach|||-7.69|-31.24|0.0016
72363631|NCT02224560|144238578|SUPERIORITY||Odds Ratio (OR)|3.85||||0.0006|TWO_SIDED|95.0|1.75|8.47||Calculated using a Cochran-Mantel-Haenszel (CMH) test stratified by age group (2-5, 6-11, 12-17 and 18-55 years)|Cochran-Mantel-Haenszel|||||8.47|1.75|0.0006
72363632|NCT02224560|144238578|SUPERIORITY||Odds Ratio (OR)|3.27||||0.003|TWO_SIDED|95.0|1.47|7.26||Calculated using a CMH test stratified by age group (2-5, 6-11, 12-17 and 18-55 years)|Cochran-Mantel-Haenszel|||||7.26|1.47|0.0030
72363633|NCT02224560|144238579|SUPERIORITY||Median Difference (Final Values)|-18.76||||0.0091|TWO_SIDED|95.0|-31.8|-4.43|||Wilcoxon rank-sum test||Calculated using the Hodges-Lehmann approach|||-4.43|-31.80|0.0091
72363634|NCT02224560|144238579|SUPERIORITY||Median Difference (Final Values)|-19.47||||0.0015|TWO_SIDED|95.0|-30.37|-7.47|||Wilcoxon rank-sum test||Calculated using the Hodges-Lehmann approach|||-7.47|-30.37|0.0015
72363635|NCT02224560|144238580|SUPERIORITY||Odds Ratio (OR)|1.83||||0.0439|TWO_SIDED|95.0|1.02|3.3|||Regression, Logistic|Ordinal logistic regression model with treatment group as a fixed factor|Odds of participant recording a lower score (improvement) on a continuous scale|||3.30|1.02|0.0439
72363636|NCT02224560|144238580|SUPERIORITY||Odds Ratio (OR)|2.57||||0.002|TWO_SIDED|95.0|1.41|4.66|||Regression, Logistic|Ordinal logistic regression model with treatment group as a fixed factor|Odds of participant recording a lower score (improvement) on a continuous scale|||4.66|1.41|0.0020
72363637|NCT03165617|144238586|SUPERIORITY|Success criterion were met as the LL of the 2-sided 95% CI was above 20%.|Absolute Efficacy|54.63|||||TWO_SIDED|95.0|45.67|62.12||||||Statistical Analysis title - Absolute Vaccine Efficacy Any Strain. Adjusted aVE for QIVc vs. comparator. Success criteria for the primary efficacy endpoint was met if the LL of the 2-sided 95% CI of the aVE estimate was greater than 20% (primary endpoint) using the protocol definition of ILI for the entire age range (2 to \<18 years of age).||62.12|45.67|
72363638|NCT03165617|144238587|SUPERIORITY|Success criteria was met as the LL of the 2-sided 95% CI of the VE estimate was greater than 30% (co-primary endpoint)|Absolute Vaccine Efficacy|54.03|||||TWO_SIDED|95.0|44.8|61.71||||||Statistical analysis title - Absolute Vaccine Efficacy, Any Strain Adjusted aVE for QIVc vs. comparator. Success criteria for the primary efficacy endpoint was met if the LL of the 2-sided 95% CI of the aVE estimate was greater than 30% (co-primary endpoint) using the protocol definition of ILI for the entire age range (≥ 3 to \<18 years of age).||61.71|44.8|
72363639|NCT03165617|144238588|SUPERIORITY|"Statistical analysis description:~Absolute Vaccine Efficacy (aVE) for 2 to \<18 Years. Note that no prespecified criteria for success were defined for the secondary efficacy endpoints"|Absolute Vaccine Efficacy|54.63|||||TWO_SIDED|95.0|45.67|62.12||||||Statistical analysis title Absolute Vaccine Efficacy, Any Strain, 2 to \<18yrs||62.12|45.67|
72363640|NCT03165617|144238588|SUPERIORITY|"Statistical analysis description:~Absolute Vaccine Efficacy (aVE) for 2 to \<9 Years. Note that no prespecified criteria for success were defined for the secondary efficacy endpoints"|Absolute Vaccine Efficacy|50.51|||||TWO_SIDED|95.0|38.43|60.22||||||Statistical analysis title: Absolute Vaccine Efficacy, Any Strain, 2 to \<9yrs||60.22|38.43|
72363641|NCT03165617|144238588|SUPERIORITY|"Statistical analysis description:~Absolute Vaccine Efficacy (aVE) for 4 to \<18 years. Note that no prespecified criteria for success were defined for the secondary efficacy endpoints"|Absolute Vaccine Efficacy|53.33|||||TWO_SIDED|95.0|43.38|61.54||||||Statistical analysis title: Absolute Vaccine Efficacy, Any Strain, 4 to \<18yrs||61.54|43.38|
72363642|NCT03165617|144238588|SUPERIORITY|"Statistical analysis description:~Absolute Vaccine Efficacy (aVE) for 9 to \<18 years. Note that no prespecified criteria for success were defined for the secondary efficacy endpoints"|Absolute Vaccine Efficacy|61.85|||||TWO_SIDED|95.0|47.37|72.34||||||Statistical analysis title Absolute Vaccine Efficacy, Any Strain, 9 to \<18yrs||72.34|47.37|
72363643|NCT03165617|144238589|SUPERIORITY|Absolute Vaccine Efficacy (aVE) for 2 to \<18 years. Note that no prespecified criteria for success were defined for the secondary efficacy endpoints|Absolute Vaccine Efficacy|54.63|||||TWO_SIDED|95.0|45.67|62.12||||||Statistical analysis title Absolute Vaccine Efficacy, Any Strain, 2 to \<18yrs||62.12|45.67|
72363644|NCT03165617|144238589|SUPERIORITY|"Statistical analysis description:~Absolute Vaccine Efficacy (aVE) for 2 to \<9 years. Note that no prespecified criteria for success were defined for the secondary efficacy endpoints"|Absolute Vaccine Efficacy|60.78|||||TWO_SIDED|95.0|49.01|69.83||||||Statistical analysis title Absolute Vaccine Efficacy, Any Strain, 2 to \<9yrs||69.83|49.01|
72363645|NCT03165617|144238589|SUPERIORITY|"Statistical analysis description:~Absolute Vaccine Efficacy (aVE) for 4 to \<18 years. Note that no prespecified criteria for success were defined for the secondary efficacy endpoints"|Absolute Vaccine Efficacy|59.66|||||TWO_SIDED|95.0|49.08|68.05||||||Statistical analysis title Absolute Vaccine Efficacy, Any Strain, 4 to \<18yrs||68.05|49.08|
72363646|NCT03165617|144238589|SUPERIORITY|"Statistical analysis description:~Absolute Vaccine Efficacy (aVE) for 9 to \<18 years. Note that no prespecified criteria for success were defined for the secondary efficacy endpoints"|Absolute Vaccine Efficacy|60.72|||||TWO_SIDED|95.0|42.14|73.33||||||Statistical analysis title Absolute Vaccine Efficacy, Any Strain, 9 to \<18yrs||73.33|42.14|
72430382|NCT02886728|144371750|SUPERIORITY||Least Squares Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-0.9|-0.6||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.6|-0.9|<0.001
72430383|NCT02886728|144371750|SUPERIORITY||Least Squares Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.7|-0.3||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.3|-0.7|<0.001
72430384|NCT02886728|144371750|SUPERIORITY||Least Squares Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.7|-0.3||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.3|-0.7|<0.001
72430385|NCT02886728|144371750|SUPERIORITY||Least Squares Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-0.6|-0.3||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.3|-0.6|<0.001
72430386|NCT02886728|144371750|SUPERIORITY||Least Squares Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.1||0.033|TWO_SIDED|95.0|-0.4|0.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.0|-0.4|0.033
72430387|NCT02886728|144371750|SUPERIORITY||Least Squares Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.6|-0.2||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.2|-0.6|<0.001
72430388|NCT02886728|144371750|SUPERIORITY||Least Squares Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-0.8|-0.5||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.5|-0.8|<0.001
72430389|NCT02886728|144371750|SUPERIORITY||Least Squares Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.6|-0.2||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.2|-0.6|<0.001
72430390|NCT02886728|144371750|SUPERIORITY||Least Squares Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.7|-0.3||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.3|-0.7|<0.001
72430391|NCT02886728|144371751|SUPERIORITY||Difference in Response Rates|18.8|||<|0.001|TWO_SIDED|95.0|13.1|24.4||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 4||24.4|13.1|<0.001
72430392|NCT02886728|144371751|SUPERIORITY||Difference in Response Rates|11.7|||<|0.001|TWO_SIDED|95.0|4.7|18.6||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 4||18.6|4.7|<0.001
72430393|NCT02886728|144371751|SUPERIORITY||Difference in Response Rates|19.9|||<|0.001|TWO_SIDED|95.0|12.5|27.3||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 4||27.3|12.5|<0.001
72430394|NCT02886728|144371751|SUPERIORITY||Difference in Response Rates|27.2|||<|0.001|TWO_SIDED|95.0|20.5|33.9||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 12||33.9|20.5|<0.001
72430395|NCT02886728|144371751|SUPERIORITY||Difference in Response Rates|21.6|||<|0.001|TWO_SIDED|95.0|13.2|30.1||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 12||30.1|13.2|<0.001
72430396|NCT02886728|144371751|SUPERIORITY||Difference in Response Rates|19.5|||<|0.001|TWO_SIDED|95.0|11.1|27.9||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 12||27.9|11.1|<0.001
72430397|NCT02886728|144371751|SUPERIORITY||Difference in Response Rates|22.6|||<|0.001|TWO_SIDED|95.0|15.8|29.4||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 24||29.4|15.8|<0.001
72430398|NCT02886728|144371751|SUPERIORITY||Difference in Response Rates|16.6|||<|0.001|TWO_SIDED|95.0|8.1|25.2||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 24||25.2|8.1|<0.001
72430399|NCT02886728|144371751|SUPERIORITY||Difference in Response Rates|13.8|||<|0.001|TWO_SIDED|95.0|5.3|22.4||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 24||22.4|5.3|<0.001
72430400|NCT02886728|144371751|SUPERIORITY||Difference in Response Rates|21.4|||<|0.001|TWO_SIDED|95.0|14.6|28.2||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 52||28.2|14.6|<0.001
72430401|NCT02886728|144371751|SUPERIORITY||Difference in Response Rates|12.3||||0.003|TWO_SIDED|95.0|3.7|20.9||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 52||20.9|3.7|0.003
72430402|NCT02886728|144371751|SUPERIORITY||Difference in Response Rates|18.1|||<|0.001|TWO_SIDED|95.0|9.7|26.5||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 52||26.5|9.7|<0.001
72430403|NCT02886728|144371752|SUPERIORITY||Difference in Response Rates|6.3|||<|0.001|TWO_SIDED|95.0|3.4|9.1||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 2||9.1|3.4|<0.001
72430404|NCT02886728|144371752|SUPERIORITY||Difference in Response Rates|3.4||||0.01|TWO_SIDED|95.0|0.1|6.7||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model|Regression, Logistic|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 2||6.7|0.1|0.010
72430405|NCT02886728|144371752|SUPERIORITY||Difference in Response Rates|9.0|||<|0.001|TWO_SIDED|95.0|4.5|13.6||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model|Regression, Logistic|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 2||13.6|4.5|<0.001
72430406|NCT02886728|144371752|SUPERIORITY||Difference in Response Rates|11.8|||<|0.001|TWO_SIDED|95.0|7.4|16.1||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model|Regression, Logistic|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 4||16.1|7.4|<0.001
72430407|NCT02886728|144371752|SUPERIORITY||Difference in Response Rates|10.2|||<|0.001|TWO_SIDED|95.0|4.5|15.8||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model|Regression, Logistic|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 4||15.8|4.5|<0.001
72430408|NCT02886728|144371752|SUPERIORITY||Difference in Response Rates|14.7|||<|0.001|TWO_SIDED|95.0|8.6|20.8||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model|Regression, Logistic|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 4||20.8|8.6|<0.001
72430409|NCT02886728|144371752|SUPERIORITY||Difference in Response Rates|22.6|||<|0.001|TWO_SIDED|95.0|16.4|28.8||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model|Regression, Logistic|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 12||28.8|16.4|<0.001
72430410|NCT02886728|144371752|SUPERIORITY||Difference in Response Rates|14.8|||<|0.001|TWO_SIDED|95.0|7.1|22.5||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model|Regression, Logistic|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 12||22.5|7.1|<0.001
72430411|NCT02886728|144371752|SUPERIORITY||Difference in Response Rates|12.5|||<|0.001|TWO_SIDED|95.0|4.9|20.0||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model|Regression, Logistic|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 12||20.0|4.9|<0.001
72430412|NCT02886728|144371752|SUPERIORITY||Difference in Response Rates|18.3|||<|0.001|TWO_SIDED|95.0|11.4|25.1||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 36||25.1|11.4|<0.001
72430413|NCT02886728|144371752|SUPERIORITY||Difference in Response Rates|7.7||||0.056|TWO_SIDED|95.0|-0.8|16.1||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model|Regression, Logistic|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 36||16.1|-0.8|0.056
72430414|NCT02886728|144371752|SUPERIORITY||Difference in Response Rates|9.0||||0.023|TWO_SIDED|95.0|0.5|17.4||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 36||17.4|0.5|0.023
72430415|NCT02886728|144371752|SUPERIORITY||Difference in Response Rates|21.9|||<|0.001|TWO_SIDED|95.0|15.1|28.7||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 52||28.7|15.1|<0.001
72430416|NCT02886728|144371752|SUPERIORITY||Difference in Response Rates|11.5||||0.004|TWO_SIDED|95.0|3.1|20.0||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 52||20.0|3.1|0.004
72430417|NCT02886728|144371752|SUPERIORITY||Difference in Response Rates|14.7|||<|0.001|TWO_SIDED|95.0|6.3|23.1||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 52||23.1|6.3|<0.001
72430418|NCT02886728|144371755|SUPERIORITY||Least Squares Mean Difference|-5.7|STANDARD_ERROR_OF_MEAN|0.82|<|0.001|TWO_SIDED|95.0|-7.3|-4.1||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-4.1|-7.3|<0.001
72430419|NCT02886728|144371755|SUPERIORITY||Least Squares Mean Difference|-4.4|STANDARD_ERROR_OF_MEAN|1.01|<|0.001|TWO_SIDED|95.0|-6.4|-2.4||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-2.4|-6.4|<0.001
72430420|NCT02886728|144371755|SUPERIORITY||Least Squares Mean Difference|-5.7|STANDARD_ERROR_OF_MEAN|1.01|<|0.001|TWO_SIDED|95.0|-7.7|-3.7||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-3.7|-7.7|<0.001
72430421|NCT02886728|144371755|SUPERIORITY||Least Squares Mean Difference|-7.3|STANDARD_ERROR_OF_MEAN|0.83|<|0.001|TWO_SIDED|95.0|-8.9|-5.6||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-5.6|-8.9|<0.001
72430422|NCT02886728|144371755|SUPERIORITY||Least Squares Mean Difference|-5.3|STANDARD_ERROR_OF_MEAN|1.02|<|0.001|TWO_SIDED|95.0|-7.3|-3.3||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-3.3|-7.3|<0.001
72430423|NCT02886728|144371755|SUPERIORITY||Least Squares Mean Difference|-5.7|STANDARD_ERROR_OF_MEAN|1.02|<|0.001|TWO_SIDED|95.0|-7.8|-3.7||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-3.7|-7.8|<0.001
72430424|NCT02886728|144371755|SUPERIORITY||Least Squares Mean Difference|-5.8|STANDARD_ERROR_OF_MEAN|0.72|<|0.001|TWO_SIDED|95.0|-7.3|-4.4||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-4.4|-7.3|<0.001
72430425|NCT02886728|144371755|SUPERIORITY||Least Squares Mean Difference|-4.4|STANDARD_ERROR_OF_MEAN|0.88|<|0.001|TWO_SIDED|95.0|-6.1|-2.7||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-2.7|-6.1|<0.001
72430426|NCT02886728|144371755|SUPERIORITY||Least Squares Mean Difference|-5.1|STANDARD_ERROR_OF_MEAN|0.88|<|0.001|TWO_SIDED|95.0|-6.8|-3.4||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-3.4|-6.8|<0.001
72430427|NCT02886728|144371755|SUPERIORITY||Least Squares Mean Difference|-4.1|STANDARD_ERROR_OF_MEAN|0.61|<|0.001|TWO_SIDED|95.0|-5.3|-2.9||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-2.9|-5.3|<0.001
72430428|NCT02886728|144371755|SUPERIORITY||Least Squares Mean Difference|-2.8|STANDARD_ERROR_OF_MEAN|0.75|<|0.001|TWO_SIDED|95.0|-4.3|-1.3||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-1.3|-4.3|<0.001
72430429|NCT02886728|144371755|SUPERIORITY||Least Squares Mean Difference|-2.9|STANDARD_ERROR_OF_MEAN|0.75|<|0.001|TWO_SIDED|95.0|-4.4|-1.4||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-1.4|-4.4|<0.001
72430430|NCT02886728|144371755|SUPERIORITY||Least Squares Mean Difference|-2.2|STANDARD_ERROR_OF_MEAN|0.59|<|0.001|TWO_SIDED|95.0|-3.4|-1.1||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-1.1|-3.4|<0.001
72363647|NCT03165617|144238590|SUPERIORITY|"Statistical analysis description:~Absolute Vaccine Efficacy (aVE) for 2 to \<18 Years. Note that no prespecified criteria for success were defined for the secondary efficacy endpoints"|Absolute Vaccine Efficacy|60.81|||||TWO_SIDED|95.0|51.3|68.46||||||Statistical analysis title Absolute Vaccine Efficacy, Any Strain, 2 to \<18yrs||68.46|51.3|
72430431|NCT02886728|144371755|SUPERIORITY||Least Squares Mean Difference|-0.65|STANDARD_ERROR_OF_MEAN|0.71||0.36|TWO_SIDED|95.0|-2.0|0.8||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||0.8|-2.0|0.36
72430432|NCT02886728|144371755|SUPERIORITY||Least Squares Mean Difference|-1.9|STANDARD_ERROR_OF_MEAN|0.72||0.009|TWO_SIDED|95.0|-3.3|-0.5||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.5|-3.3|0.009
72430433|NCT02886728|144371755|SUPERIORITY||Least Squares Mean Difference|-3.3|STANDARD_ERROR_OF_MEAN|0.56|<|0.001|TWO_SIDED|95.0|-4.5|-2.2||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-2.2|-4.5|<0.001
72430434|NCT02886728|144371755|SUPERIORITY||Least Squares Mean Difference|-1.4|STANDARD_ERROR_OF_MEAN|0.69||0.042|TWO_SIDED|95.0|-2.7|-0.1||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.1|-2.7|0.042
72430435|NCT02886728|144371755|SUPERIORITY||Least Squares Mean Difference|-2.4|STANDARD_ERROR_OF_MEAN|0.69|<|0.001|TWO_SIDED|95.0|-3.7|-1.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-1.0|-3.7|<0.001
72430436|NCT02886728|144371756|SUPERIORITY||Least Squares Mean Difference|-6.8|STANDARD_ERROR_OF_MEAN|0.85|<|0.001|TWO_SIDED|95.0|-8.5|-5.2||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-5.2|-8.5|<0.001
72430437|NCT02886728|144371756|SUPERIORITY||Least Squares Mean Difference|-5.3|STANDARD_ERROR_OF_MEAN|1.04|<|0.001|TWO_SIDED|95.0|-7.3|-3.3||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-3.3|-7.3|<0.001
72430438|NCT02886728|144371756|SUPERIORITY||Least Squares Mean Difference|-6.7|STANDARD_ERROR_OF_MEAN|1.03|<|0.001|TWO_SIDED|95.0|-8.8|-4.7||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-4.7|-8.8|<0.001
72430439|NCT02886728|144371756|SUPERIORITY||Least Squares Mean Difference|-8.3|STANDARD_ERROR_OF_MEAN|0.85|<|0.001|TWO_SIDED|95.0|-9.9|-6.6||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-6.6|-9.9|<0.001
72430440|NCT02886728|144371756|SUPERIORITY||Least Squares Mean Difference|-6.2|STANDARD_ERROR_OF_MEAN|1.04|<|0.001|TWO_SIDED|95.0|-8.2|-4.1||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-4.1|-8.2|<0.001
72430441|NCT02886728|144371756|SUPERIORITY||Least Squares Mean Difference|-6.5|STANDARD_ERROR_OF_MEAN|1.04|<|0.001|TWO_SIDED|95.0|-8.5|-4.5||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-4.5|-8.5|<0.001
72430442|NCT02886728|144371756|SUPERIORITY||Least Squares Mean Difference|-6.5|STANDARD_ERROR_OF_MEAN|0.74|<|0.001|TWO_SIDED|95.0|-8.0|-5.1||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-5.1|-8.0|<0.001
72430443|NCT02886728|144371756|SUPERIORITY||Least Squares Mean Difference|-4.8|STANDARD_ERROR_OF_MEAN|0.9|<|0.001|TWO_SIDED|95.0|-6.5|-3.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-3.0|-6.5|<0.001
72430444|NCT02886728|144371756|SUPERIORITY||Least Squares Mean Difference|-5.6|STANDARD_ERROR_OF_MEAN|0.9|<|0.001|TWO_SIDED|95.0|-7.4|-3.8||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-3.8|-7.4|<0.001
72430445|NCT02886728|144371756|SUPERIORITY||Least Squares Mean Difference|-4.6|STANDARD_ERROR_OF_MEAN|0.64|<|0.001|TWO_SIDED|95.0|-5.9|-3.4||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-3.4|-5.9|<0.001
72430446|NCT02886728|144371756|SUPERIORITY||Least Squares Mean Difference|-3.1|STANDARD_ERROR_OF_MEAN|0.78|<|0.001|TWO_SIDED|95.0|-4.6|-1.6||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-1.6|-4.6|<0.001
72430447|NCT02886728|144371756|SUPERIORITY||Least Squares Mean Difference|-3.4|STANDARD_ERROR_OF_MEAN|0.79|<|0.001|TWO_SIDED|95.0|-4.9|-1.9||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-1.9|-4.9|<0.001
72430448|NCT02886728|144371756|SUPERIORITY||Least Squares Mean Difference|-2.6|STANDARD_ERROR_OF_MEAN|0.61|<|0.001|TWO_SIDED|95.0|-3.8|-1.4||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-1.4|-3.8|<0.001
72430449|NCT02886728|144371756|SUPERIORITY||Least Squares Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|0.74||0.23|TWO_SIDED|95.0|-2.4|0.6||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||0.6|-2.4|0.23
72430450|NCT02886728|144371756|SUPERIORITY||Least Squares Mean Difference|-2.1|STANDARD_ERROR_OF_MEAN|0.75||0.005|TWO_SIDED|95.0|-3.6|-0.6||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.6|-3.6|0.005
72430451|NCT02886728|144371756|SUPERIORITY||Least Squares Mean Difference|-3.8|STANDARD_ERROR_OF_MEAN|0.6|<|0.001|TWO_SIDED|95.0|-5.0|-2.6||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-2.6|-5.0|<0.001
72430452|NCT02886728|144371756|SUPERIORITY||Least Squares Mean Difference|-1.7|STANDARD_ERROR_OF_MEAN|0.73||0.021|TWO_SIDED|95.0|-3.1|-0.3||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.3|-3.1|0.021
72430453|NCT02886728|144371756|SUPERIORITY||Least Squares Mean Difference|-2.8|STANDARD_ERROR_OF_MEAN|0.73|<|0.001|TWO_SIDED|95.0|-4.3|-1.4||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-1.4|-4.3|<0.001
72430454|NCT02886728|144371757|SUPERIORITY||Difference in Response Rates|7.6||||0.006|TWO_SIDED|95.0|2.2|12.9||P-value was calculated from the logistic regression with treatment groups, and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 24 for Change in mTSS \<= 0.5||12.9|2.2|0.006
72430455|NCT02886728|144371757|SUPERIORITY||Difference in Response Rates|4.9||||0.16|TWO_SIDED|95.0|-1.8|11.6||P-value was calculated from the logistic regression with treatment groups, and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 24 for Change in mTSS \<= 0.5||11.6|-1.8|0.16
72430456|NCT02886728|144371757|SUPERIORITY||Difference in Response Rates|7.6||||0.029|TWO_SIDED|95.0|1.1|14.1||P-value was calculated from the logistic regression with treatment groups, and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 24 for Change in mTSS \<= 0.5||14.1|1.1|0.029
72430457|NCT02886728|144371757|SUPERIORITY||Difference in Response Rates|8.1||||0.015|TWO_SIDED|95.0|1.6|14.6||P-value was calculated from the logistic regression with treatment groups, and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 24 for Change in mTSS \<= 0||14.6|1.6|0.015
72363648|NCT03165617|144238590|SUPERIORITY|"Statistical analysis description:~Absolute Vaccine Efficacy (aVE) for 2 to \<9 Years. Note that no prespecified criteria for success were defined for the secondary efficacy endpoints"|Absolute Vaccine Efficacy|60.78|||||TWO_SIDED|95.0|49.01|69.83||||||Statistical analysis title Absolute Vaccine Efficacy, Any Strain, 2 to \<9yrs||69.83|49.01|
72363649|NCT03165617|144238590|SUPERIORITY|"Statistical analysis description:~Absolute Vaccine Efficacy (aVE) for 9 to \<18 years. Note that no prespecified criteria for success were defined for the secondary efficacy endpoints"|Absolute Vaccine Efficacy|59.66|||||TWO_SIDED|95.0|49.08|68.05||||||Statistical analysis title Absolute Vaccine Efficacy, Any Strain, 9 to \<18yrs||68.05|49.08|
72363650|NCT03165617|144238590|SUPERIORITY|"Statistical analysis description:~Absolute Vaccine Efficacy (aVE) for 9 to \<18 years. Note that no prespecified criteria for success were defined for the secondary efficacy endpoints"|Absolute Vaccine Efficacy|60.72|||||TWO_SIDED|95.0|42.14|73.33||||||Statistical analysis title Absolute Vaccine Efficacy, Any Strain, 9 to \<18yrs||73.33|42.14|
72363651|NCT03165617|144238591|SUPERIORITY|"Statistical analysis description:~Absolute Vaccine Efficacy (aVE) for 2 to \<18 Years. Note that no prespecified criteria for success were defined for the secondary efficacy endpoints"|Absolute Vaccine Efficacy|63.64|||||TWO_SIDED|95.0|53.64|71.48||||||Statistical analysis title Absolute Vaccine Efficacy, Any Strain, 2 to \<18yrs||71.48|53.64|
72363652|NCT03165617|144238591|SUPERIORITY|"Statistical analysis description:~Absolute Vaccine Efficacy (aVE) for 2 to \<9 Years. Note that no prespecified criteria for success were defined for the secondary efficacy endpoints"|Absolute Vaccine Efficacy|63.04|||||TWO_SIDED|95.0|50.66|72.32||||||Statistical analysis title Absolute Vaccine Efficacy, Any Strain, 2 to \<9yrs||72.32|50.66|
72363653|NCT03165617|144238591|SUPERIORITY|"Statistical analysis description:~Absolute Vaccine Efficacy (aVE) for 4 to \<18 years. Note that no prespecified criteria for success were defined for the secondary efficacy endpoints"|Absolute Vaccine Efficacy|61.58|||||TWO_SIDED|95.0|50.25|70.53||||||Statistical analysis title Absolute Vaccine Efficacy, Any Strain, 4 to \<18yrs||70.53|50.25|
72363654|NCT03165617|144238591|SUPERIORITY|"Statistical analysis description:~Absolute Vaccine Efficacy (aVE) for 9 to \<18 years. Note that no prespecified criteria for success were defined for the secondary efficacy endpoints"|Absolute Vaccine Efficacy|64.78|||||TWO_SIDED|95.0|44.84|77.51||||||Statistical analysis title Absolute Vaccine Efficacy, Any Strain, 9 to \<18yrs||77.51|44.84|
72363655|NCT01710345|144238658|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.47|STANDARD_ERROR_OF_MEAN|4.45||0.742|ONE_SIDED|95.0|||||ANCOVA|||||||0.742
72363656|NCT01710345|144238658|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.66|STANDARD_ERROR_OF_MEAN|4.47||0.003|ONE_SIDED|95.0|||||ANCOVA|||||||0.003
72363657|NCT02153632|144238694|SUPERIORITY||Mean Difference (Final Values)|-5.5|STANDARD_ERROR_OF_MEAN|1.75||0.031|TWO_SIDED|95.0|-10.5|-0.5|||ANCOVA|||||-0.5|-10.5|0.031
72363658|NCT02153632|144238694|SUPERIORITY||Mean Difference (Final Values)|-6.5|STANDARD_ERROR_OF_MEAN|1.71||0.011|TWO_SIDED|95.0|-11.5|-1.5|||ANCOVA|||||-1.5|-11.5|0.011
72363659|NCT00124943|144238697|SUPERIORITY_OR_OTHER|||||||0.396||95.0|||||Fisher Exact|||The statistical testing of treatment difference is for exploratory purposes.||||0.396
72363660|NCT00124943|144238698|SUPERIORITY_OR_OTHER|||||||0.783||95.0|||||Fisher Exact|||Comparison of the number of patients with any treatment emergent adverse event. The statistical testing of treatment difference is for exploratory purposes.||||0.783
72363661|NCT00124943|144238699|SUPERIORITY_OR_OTHER|||||||0.293||95.0|||||Fisher Exact|||Comparison of in-stent binary restenosis. The statistical testing of treatment difference is for exploratory purposes.||||0.293
72363662|NCT00124943|144238699|SUPERIORITY_OR_OTHER|||||||0.4||95.0|||||Fisher Exact|||Comparison of in-segment binary restenosis. The statistical testing of treatment difference is for exploratory purposes||||0.400
72363663|NCT00124943|144238700|SUPERIORITY_OR_OTHER||||||>|0.999||95.0|||||Fisher Exact|||The statistical testing of treatment difference is for exploratory purposes.||||>0.999
72363664|NCT00124943|144238701|SUPERIORITY_OR_OTHER|||||||0.061||95.0|||||Fisher Exact|||The statistical testing of treatment difference is for exploratory purposes.||||0.061
72363665|NCT00124943|144238702|SUPERIORITY_OR_OTHER|||||||0.709||95.0|||||Fisher Exact|||Comparison of in-stent late lumen loss. The statistical testing of treatment difference is for exploratory purposes.||||0.709
72363666|NCT00124943|144238702|SUPERIORITY_OR_OTHER|||||||0.495||95.0|||||Fisher Exact|||Comparison of in-segment late lumen loss. The statistical testing of treatment difference is for exploratory purposes.||||0.495
72363667|NCT00124943|144238703|SUPERIORITY_OR_OTHER|||||||0.317||95.0|||||ANOVA|P-value testing dose group differences based on an analysis of variance with dose effect in the model.||||||0.317
72363668|NCT00321620|144238704|NON_INFERIORITY_OR_EQUIVALENCE|A synthesis method was used for the non-inferiority test for the hypothesis that denosumab preserves as least 50% of the effect of zoledronic acid vs. placebo.|Hazard Ratio (HR)|0.82||||0.0002||95.0|0.71|0.95|||Regression, Cox||Stratified by the randomization stratification factors (previous skeletal-related event, prostate-specific antigen level, and current chemotherapy)|||0.95|0.71|0.0002
72363669|NCT00321620|144238705|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.82||||0.0085||95.0|0.71|0.95|||Regression, Cox|P-value was adjusted for multiplicity according to a hierarchical testing strategy and Hochberg procedure.|Stratified by the randomization stratification factors (previous skeletal-related event, prostate-specific antigen level, and current chemotherapy).|||0.95|0.71|0.0085
72363670|NCT00321620|144238706|SUPERIORITY_OR_OTHER||Rate ratio|0.82||||0.0085||95.0|0.71|0.94|||Anderson-Gill model|P-value was adjusted for multiplicity according to a hierarchical testing strategy and Hochberg procedure.|Stratified by the randomization stratification factors (previous skeletal-related event, prostate-specific antigen level, and current chemotherapy).|||0.94|0.71|0.0085
72363671|NCT02844569|144238707|SUPERIORITY|||||||0.11|||||||t-test, 2 sided|||||||0.11
72363672|NCT02844569|144238708|SUPERIORITY||||||<|0.01|||||||Mixed Models Analysis|||||||<0.01
72363673|NCT02844569|144238709|SUPERIORITY|||||||0.66|||||||t-test, 2 sided|||||||0.66
72363674|NCT03137381|144238737|SUPERIORITY|||||||0.177|||||||Chi-squared|||||||0.177
72363675|NCT03137381|144238737|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
72363676|NCT03137381|144238737|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
72430458|NCT02886728|144371757|SUPERIORITY||Difference in Response Rates|4.2||||0.33|TWO_SIDED|95.0|-3.9|12.2||P-value was calculated from the logistic regression with treatment groups, and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 24 for Change in mTSS \<= 0||12.2|-3.9|0.33
72430459|NCT02886728|144371757|SUPERIORITY||Difference in Response Rates|10.2||||0.013|TWO_SIDED|95.0|2.5|17.9||P-value was calculated from the logistic regression with treatment groups, and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 24 for Change in mTSS \<= 0||17.9|2.5|0.013
72430460|NCT02886728|144371757|SUPERIORITY||Difference in Response Rates|3.6||||0.074|TWO_SIDED|95.0|-0.3|7.6||P-value was calculated from the logistic regression with treatment groups, and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 24 for Change in mTSS \<= SDC (1.53)||7.6|-0.3|0.074
72430461|NCT02886728|144371757|SUPERIORITY||Difference in Response Rates|1.9||||0.49|TWO_SIDED|95.0|-3.1|6.9||P-value was calculated from the logistic regression with treatment groups, and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 24 for Change in mTSS \<= SDC (1.53)||6.9|-3.1|0.49
72430462|NCT02886728|144371757|SUPERIORITY||Difference in Response Rates|4.4||||0.075|TWO_SIDED|95.0|-0.2|8.9||P-value was calculated from the logistic regression with treatment groups, and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 24 for Change in mTSS \<= SDC (1.53)||8.9|-0.2|0.075
72430463|NCT02886728|144371757|SUPERIORITY||Difference in Response Rates|10.2|||<|0.001|TWO_SIDED|95.0|4.3|16.2||P-value was calculated from the logistic regression with treatment groups, stratification factors and campaign groups in the model.|Regression, Logistic|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 52 for Change in mTSS \<= 0.5||16.2|4.3|<0.001
72430464|NCT02886728|144371757|SUPERIORITY||Difference in Response Rates|7.9||||0.045|TWO_SIDED|95.0|0.7|15.2||P-value was calculated from the logistic regression with treatment groups, stratification factors and campaign groups in the model.|Regression, Logistic|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 52 for Change in mTSS \<= 0.5||15.2|0.7|0.045
72430465|NCT02886728|144371757|SUPERIORITY||Difference in Response Rates|6.5||||0.1|TWO_SIDED|95.0|-1.1|14.0||P-value was calculated from the logistic regression with treatment groups, stratification factors and campaign groups in the model.|Regression, Logistic|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 52 for Change in mTSS \<= 0.5||14.0|-1.1|0.100
72430466|NCT02886728|144371757|SUPERIORITY||Difference in Response Rates|10.0||||0.004|TWO_SIDED|95.0|3.2|16.7||P-value was calculated from the logistic regression with treatment groups, stratification factors and campaign groups in the model.|Regression, Logistic|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 52 for Change in mTSS \<= 0||16.7|3.2|0.004
72430467|NCT02886728|144371757|SUPERIORITY||Difference in Response Rates|5.5||||0.25|TWO_SIDED|95.0|-2.9|14.0||P-value was calculated from the logistic regression with treatment groups, stratification factors and campaign groups in the model.|Regression, Logistic|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 52 for Change in mTSS \<= 0||14.0|-2.9|0.25
72430468|NCT02886728|144371757|SUPERIORITY||Difference in Response Rates|6.5||||0.14|TWO_SIDED|95.0|-2.0|15.0||P-value was calculated from the logistic regression with treatment groups, stratification factors and campaign groups in the model.|Regression, Logistic|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 52 for Change in mTSS \<= 0||15.0|-2.0|0.14
72430469|NCT02886728|144371757|SUPERIORITY||Difference in Response Rates|7.5||||0.002|TWO_SIDED|95.0|2.8|12.3||P-value was calculated from the logistic regression with treatment groups, stratification factors and campaign groups in the model.|Regression, Logistic|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 52 for Change in mTSS \<= SDC (1.77)||12.3|2.8|0.002
72430470|NCT02886728|144371757|SUPERIORITY||Difference in Response Rates|8.2||||0.008|TWO_SIDED|95.0|2.9|13.6||P-value was calculated from the logistic regression with treatment groups, stratification factors and campaign groups in the model.|Regression, Logistic|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 52 for Change in mTSS \<= SDC (1.77)||13.6|2.9|0.008
72430471|NCT02886728|144371757|SUPERIORITY||Difference in Response Rates|2.5||||0.47|TWO_SIDED|95.0|-3.9|8.9||P-value was calculated from the logistic regression with treatment groups, stratification factors and campaign groups in the model.|Regression, Logistic|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 52 for Change in mTSS \<= SDC (1.77)||8.9|-3.9|0.47
72430472|NCT02886728|144371759|SUPERIORITY||Least Squares Mean Difference|3.2|STANDARD_ERROR_OF_MEAN|0.45|<|0.001|TWO_SIDED|95.0|2.4|4.1||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||4.1|2.4|<0.001
72430473|NCT02886728|144371759|SUPERIORITY||Least Squares Mean Difference|1.8|STANDARD_ERROR_OF_MEAN|0.55||0.001|TWO_SIDED|95.0|0.7|2.8||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||2.8|0.7|0.001
72430474|NCT02886728|144371759|SUPERIORITY||Least Squares Mean Difference|2.3|STANDARD_ERROR_OF_MEAN|0.55|<|0.001|TWO_SIDED|95.0|1.3|3.4||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||3.4|1.3|<0.001
72430475|NCT02886728|144371759|SUPERIORITY||Least Squares Mean Difference|3.7|STANDARD_ERROR_OF_MEAN|0.54|<|0.001|TWO_SIDED|95.0|2.7|4.8||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||4.8|2.7|<0.001
72430476|NCT02886728|144371759|SUPERIORITY||Least Squares Mean Difference|1.7|STANDARD_ERROR_OF_MEAN|0.66||0.008|TWO_SIDED|95.0|0.5|3.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||3.0|0.5|0.008
72430477|NCT02886728|144371759|SUPERIORITY||Least Squares Mean Difference|1.5|STANDARD_ERROR_OF_MEAN|0.66||0.023|TWO_SIDED|95.0|0.2|2.8||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||2.8|0.2|0.023
72430478|NCT02886728|144371759|SUPERIORITY||Least Squares Mean Difference|1.8|STANDARD_ERROR_OF_MEAN|0.59||0.003|TWO_SIDED|95.0|0.6|2.9||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||2.9|0.6|0.003
72430479|NCT02886728|144371759|SUPERIORITY||Least Squares Mean Difference|0.6|STANDARD_ERROR_OF_MEAN|0.71||0.38|TWO_SIDED|95.0|-0.8|2.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||2.0|-0.8|0.38
72430480|NCT02886728|144371759|SUPERIORITY||Least Squares Mean Difference|0.4|STANDARD_ERROR_OF_MEAN|0.72||0.59|TWO_SIDED|95.0|-1.0|1.8||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||1.8|-1.0|0.59
72430481|NCT02886728|144371759|SUPERIORITY||Least Squares Mean Difference|2.8|STANDARD_ERROR_OF_MEAN|0.62|<|0.001|TWO_SIDED|95.0|1.6|4.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||4.0|1.6|<0.001
72430482|NCT02886728|144371759|SUPERIORITY||Least Squares Mean Difference|1.2|STANDARD_ERROR_OF_MEAN|0.76||0.11|TWO_SIDED|95.0|-0.3|2.7||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||2.7|-0.3|0.11
72430483|NCT02886728|144371759|SUPERIORITY||Least Squares Mean Difference|1.4|STANDARD_ERROR_OF_MEAN|0.76||0.071|TWO_SIDED|95.0|-0.17|2.9||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||2.9|-0.17|0.071
72430484|NCT02886728|144371761|SUPERIORITY||Least Squares Mean Difference|2.7|STANDARD_ERROR_OF_MEAN|0.57|<|0.001|TWO_SIDED|95.0|1.6|3.8||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||3.8|1.6|<0.001
72430485|NCT02886728|144371761|SUPERIORITY||Least Squares Mean Difference|1.5|STANDARD_ERROR_OF_MEAN|0.7||0.032|TWO_SIDED|95.0|0.1|2.9||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||2.9|0.1|0.032
72430486|NCT02886728|144371761|SUPERIORITY||Least Squares Mean Difference|2.4|STANDARD_ERROR_OF_MEAN|0.7|<|0.001|TWO_SIDED|95.0|1.0|3.8||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||3.8|1.0|<0.001
72430487|NCT02886728|144371761|SUPERIORITY||Least Squares Mean Difference|1.4|STANDARD_ERROR_OF_MEAN|0.6||0.023|TWO_SIDED|95.0|0.2|2.6||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||2.6|0.2|0.023
72430488|NCT02886728|144371761|SUPERIORITY||Least Squares Mean Difference|1.4|STANDARD_ERROR_OF_MEAN|0.74||0.065|TWO_SIDED|95.0|-0.1|2.8||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||2.8|-0.1|0.065
72430489|NCT02886728|144371761|SUPERIORITY||Least Squares Mean Difference|1.1|STANDARD_ERROR_OF_MEAN|0.74||0.15|TWO_SIDED|95.0|-0.4|2.5||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||2.5|-0.4|0.15
72430490|NCT02886728|144371761|SUPERIORITY||Least Squares Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|0.64||0.73|TWO_SIDED|95.0|-1.0|1.5||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||1.5|-1.0|0.73
72430491|NCT02886728|144371761|SUPERIORITY||Least Squares Mean Difference|0.7|STANDARD_ERROR_OF_MEAN|0.78||0.37|TWO_SIDED|95.0|-0.8|2.2||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||2.2|-0.8|0.37
72430492|NCT02886728|144371761|SUPERIORITY||Least Squares Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.78||0.83|TWO_SIDED|95.0|-1.7|1.4||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||1.4|-1.7|0.83
72430493|NCT02886728|144371761|SUPERIORITY||Least Squares Mean Difference|1.2|STANDARD_ERROR_OF_MEAN|0.66||0.073|TWO_SIDED|95.0|-0.1|2.5||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||2.5|-0.1|0.073
72430494|NCT02886728|144371761|SUPERIORITY||Least Squares Mean Difference|1.4|STANDARD_ERROR_OF_MEAN|0.8||0.09|TWO_SIDED|95.0|-0.2|2.9||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||2.9|-0.2|0.090
72430495|NCT02886728|144371761|SUPERIORITY||Least Squares Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.81||0.68|TWO_SIDED|95.0|-1.9|1.2||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||1.2|-1.9|0.68
72430496|NCT02886728|144371761|SUPERIORITY||Least Squares Mean Difference|0.7|STANDARD_ERROR_OF_MEAN|0.67||0.3|TWO_SIDED|95.0|-0.6|2.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||2.0|-0.6|0.30
72430497|NCT02886728|144371761|SUPERIORITY||Least Squares Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|0.82||0.69|TWO_SIDED|95.0|-1.3|1.9||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||1.9|-1.3|0.69
72430498|NCT02886728|144371761|SUPERIORITY||Least Squares Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.82||0.95|TWO_SIDED|95.0|-1.7|1.5||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||1.5|-1.7|0.95
72430499|NCT02886728|144371763|SUPERIORITY||Least Squares Mean Difference|3.2|STANDARD_ERROR_OF_MEAN|0.58|<|0.001|TWO_SIDED|95.0|2.1|4.4||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||4.4|2.1|<0.001
72430500|NCT02886728|144371763|SUPERIORITY||Least Squares Mean Difference|2.5|STANDARD_ERROR_OF_MEAN|0.7|<|0.001|TWO_SIDED|95.0|1.1|3.9||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||3.9|1.1|<0.001
72430501|NCT02886728|144371763|SUPERIORITY||Least Squares Mean Difference|2.7|STANDARD_ERROR_OF_MEAN|0.71|<|0.001|TWO_SIDED|95.0|1.3|4.1||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||4.1|1.3|<0.001
72430502|NCT02886728|144371763|SUPERIORITY||Least Squares Mean Difference|2.2|STANDARD_ERROR_OF_MEAN|0.64|<|0.001|TWO_SIDED|95.0|1.0|3.5||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||3.5|1.0|<0.001
72430503|NCT02886728|144371763|SUPERIORITY||Least Squares Mean Difference|1.2|STANDARD_ERROR_OF_MEAN|0.78||0.13|TWO_SIDED|95.0|-0.4|2.7||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||2.7|-0.4|0.13
72430504|NCT02886728|144371763|SUPERIORITY||Least Squares Mean Difference|1.7|STANDARD_ERROR_OF_MEAN|0.79||0.032|TWO_SIDED|95.0|0.1|3.2||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||3.2|0.1|0.032
72430505|NCT02886728|144371763|SUPERIORITY||Least Squares Mean Difference|1.5|STANDARD_ERROR_OF_MEAN|0.67||0.028|TWO_SIDED|95.0|0.2|2.8||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||2.8|0.2|0.028
72430506|NCT02886728|144371763|SUPERIORITY||Least Squares Mean Difference|1.2|STANDARD_ERROR_OF_MEAN|0.81||0.15|TWO_SIDED|95.0|-0.4|2.7||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||2.7|-0.4|0.15
72430507|NCT02886728|144371763|SUPERIORITY||Least Squares Mean Difference|0.7|STANDARD_ERROR_OF_MEAN|0.81||0.41|TWO_SIDED|95.0|-0.9|2.3||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||2.3|-0.9|0.41
72430508|NCT02886728|144371763|SUPERIORITY||Least Squares Mean Difference|1.7|STANDARD_ERROR_OF_MEAN|0.71||0.017|TWO_SIDED|95.0|0.3|3.1||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||3.1|0.3|0.017
72430509|NCT02886728|144371763|SUPERIORITY||Least Squares Mean Difference|1.0|STANDARD_ERROR_OF_MEAN|0.86||0.27|TWO_SIDED|95.0|-0.7|2.6||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||2.6|-0.7|0.27
72430510|NCT02886728|144371763|SUPERIORITY||Least Squares Mean Difference|1.2|STANDARD_ERROR_OF_MEAN|0.87||0.15|TWO_SIDED|95.0|-0.5|2.9||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||2.9|-0.5|0.15
72430511|NCT02886728|144371766|SUPERIORITY||Least Squares Mean Difference|9.0|STANDARD_ERROR_OF_MEAN|1.3|<|0.001|TWO_SIDED|95.0|6.0|12.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||12.0|6.0|<0.001
72430512|NCT02886728|144371766|SUPERIORITY||Least Squares Mean Difference|4.0|STANDARD_ERROR_OF_MEAN|1.6||0.006|TWO_SIDED|95.0|1.0|8.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||8.0|1.0|0.006
72430513|NCT02886728|144371766|SUPERIORITY||Least Squares Mean Difference|6.0|STANDARD_ERROR_OF_MEAN|1.6|<|0.001|TWO_SIDED|95.0|3.0|9.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||9.0|3.0|<0.001
72430514|NCT02886728|144371766|SUPERIORITY||Least Squares Mean Difference|5.0|STANDARD_ERROR_OF_MEAN|1.5|<|0.001|TWO_SIDED|95.0|2.0|8.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||8.0|2.0|<0.001
72430515|NCT02886728|144371766|SUPERIORITY||Least Squares Mean Difference|3.0|STANDARD_ERROR_OF_MEAN|1.8||0.089|TWO_SIDED|95.0|0.0|7.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||7.0|-0.0|0.089
72430516|NCT02886728|144371766|SUPERIORITY||Least Squares Mean Difference|2.0|STANDARD_ERROR_OF_MEAN|1.9||0.18|TWO_SIDED|95.0|-1.0|6.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||6.0|-1.0|0.18
72430517|NCT02886728|144371766|SUPERIORITY||Least Squares Mean Difference|4.0|STANDARD_ERROR_OF_MEAN|1.5||0.003|TWO_SIDED|95.0|1.0|7.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||7.0|1.0|0.003
72430518|NCT02886728|144371766|SUPERIORITY||Least Squares Mean Difference|4.0|STANDARD_ERROR_OF_MEAN|1.8||0.049|TWO_SIDED|95.0|0.0|7.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||7.0|0.0|0.049
72430519|NCT02886728|144371766|SUPERIORITY||Least Squares Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|1.8||0.84|TWO_SIDED|95.0|-4.0|3.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||3.0|-4.0|0.84
72430520|NCT02886728|144371766|SUPERIORITY||Least Squares Mean Difference|6.0|STANDARD_ERROR_OF_MEAN|1.6|<|0.001|TWO_SIDED|95.0|2.0|9.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||9.0|2.0|<0.001
72430521|NCT02886728|144371766|SUPERIORITY||Least Squares Mean Difference|3.0|STANDARD_ERROR_OF_MEAN|2.0||0.078|TWO_SIDED|95.0|0.0|7.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||7.0|-0.0|0.078
72430522|NCT02886728|144371766|SUPERIORITY||Least Squares Mean Difference|2.0|STANDARD_ERROR_OF_MEAN|2.0||0.39|TWO_SIDED|95.0|-2.0|6.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||6.0|-2.0|0.39
72430523|NCT02886728|144371766|SUPERIORITY||Least Squares Mean Difference|5.0|STANDARD_ERROR_OF_MEAN|1.7||0.004|TWO_SIDED|95.0|2.0|8.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||8.0|2.0|0.004
72430524|NCT02886728|144371766|SUPERIORITY||Least Squares Mean Difference|2.0|STANDARD_ERROR_OF_MEAN|2.1||0.45|TWO_SIDED|95.0|-3.0|6.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||6.0|-3.0|0.45
72430525|NCT02886728|144371766|SUPERIORITY||Least Squares Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|2.1||0.85|TWO_SIDED|95.0|-4.0|5.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||5.0|-4.0|0.85
72430526|NCT00688259|144371829|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3|||||||Mixed Models Analysis|||||||.30
72430527|NCT00688259|144371830|SUPERIORITY_OR_OTHER_LEGACY|||||||0.09|||||||Mixed Models Analysis|||||||.09
72430528|NCT00688259|144371831|SUPERIORITY_OR_OTHER_LEGACY|||||||0.46|||||||Mixed Models Analysis|||||||.46
72430529|NCT00688259|144371832|SUPERIORITY_OR_OTHER_LEGACY|||||||0.55|||||||Mixed Models Analysis|||||||.55
72430530|NCT00688259|144371833|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5|||||||Mixed Models Analysis|||||||.50
72430531|NCT00688259|144371834|SUPERIORITY_OR_OTHER_LEGACY|||||||0.25|||||||Mixed Models Analysis|||||||.25
72430532|NCT02954575|144371847|OTHER||Poisson test estimate|2.13|||<|0.0001|TWO_SIDED|95.0|1.64|2.76||versus mean TABR \>29|Poisson test estimate|||A confirmative one-sided, one-sample Poisson test was used to test whether the mean annualized bleeding rate (ABR) in patients treated prophylactically with Wilate was below the threshold of 29 BEs per patient year (alpha = 2.5%). This threshold corresponds to 50% of the TABR reported in the GENA-01 study (NCT00989196), which observed 58.1 BEs per patient per year. A corresponding two-sided 95% CI for the TABR was also analyzed.||2.76|1.64|<0.0001
72430533|NCT02954575|144371848|OTHER||Poisson test estimate|1.53|||<|0.0001|TWO_SIDED|95.0|1.13|2.08||versus mean SABR \>19.1|Poisson test estimate|||A confirmative one-sided, one-sample Poisson test was used to test whether the mean SABR in patients treated prophylactically with Wilate was below the threshold of 19.1 BEs per patient year (alpha = 2.5%). This threshold corresponds to 50% of the SABR in the GENA-01 study (NCT00989196), which observed 38.2 spontaneous BEs per patient per year. A corresponding two-sided 95% CI for the SABR was also analyzed.||2.08|1.13|<0.0001
72430534|NCT02954575|144371849|OTHER||Generalized estimation equation|84.21||||0.0096|TWO_SIDED|95.0|72.13|92.52|||Confirmatory data analysis|||"Confirmatory statistical testing tested the null hypotheses that the percentage of success is ≤70% (alternative hypothesis: percentage \>70%); the test procedure based on the generalized estimation equation took into account several BEs in one patient as correlated repeated measurements (alpha = 2.5%). Thus, π denotes the proportion of success and the following pair of hypotheses was tested:~H0: π ≤ 0.7 vs. H1: π \> 0.7"||92.52|72.13|0.0096
72430535|NCT02954575|144371855|OTHER|||||||0.0346|||||||ANOVA|||||||0.0346
72430536|NCT02954575|144371856|OTHER|||||||0.4244|||||||ANOVA|||||||0.4244
72430537|NCT02954575|144371858|OTHER||Pearson-Copper|0.0|||||TWO_SIDED|95.0|0.0|16.11||||||||16.11|0|
72430538|NCT04227340|144371885|OTHER|The count, percentage and confidence interval will be calculated for allogeneic HCT patients who receive PBM and develop Grade 3 mucositis|Odds Ratio (OR)|0.2|||||TWO_SIDED|95.0|0.091|0.356|||||Odds of grade 3 in Allogeneic group compared to historical rates. The study efficacy of mucositis reduction by 20% with an estimation of 51% developing grade 3 mucositis.|The count, percentage and confidence interval were calculated for allogeneic HCT participants who receive PBM and developed Grade 3 mucositis. Whether the percentage of the prospective sample is significantly different from the estimated rate of 71% was accessed.||0.356|0.091|
72430539|NCT04227340|144371886|SUPERIORITY|||||||0.03|||||||Wilcox Rank Sum|||||||0.03
72430540|NCT04227340|144371888|SUPERIORITY|||||||0.32|||||||Wilcoxon (Mann-Whitney)|||||||0.32
72430541|NCT04227340|144371890|SUPERIORITY|||||||0.002|||||||Wilcoxon (Mann-Whitney)|||||||0.002
72430542|NCT04227340|144371892|SUPERIORITY|||||||0.1|||||||Wilcoxon (Mann-Whitney)|||||||0.1
72430543|NCT04227340|144371894|SUPERIORITY|||||||0.009|||||||Wilcoxon (Mann-Whitney)|||||||0.009
72430544|NCT03890120|144371917|SUPERIORITY||Difference in Percentages|-1.4||||0.4186|TWO_SIDED|95.0|-15.2|12.3|||Mantel Haenszel||The difference of cilofexor and placebo,95% confidence interval(CI),and P value(1-sided)were obtained by the stratum-adjusted Mantel-Haenszel (MH) method,with baseline ursodeoxycholic acid(UDCA)use and Ludwig fibrosis stage as stratification factors.|||12.3|-15.2|0.4186
72430545|NCT03890120|144371922|SUPERIORITY||Difference in Least Squares Mean (LSM)|-4.0||||0.3884|TWO_SIDED|95.0|-28.0|21.0|||ANCOVA||The LSM,95% CI and P-value(1-sided) were obtained by an analysis of covariance(ANCOVA)model with change at Week 96 as dependent variable,baseline value of outcome measure,baseline UDCA use, and baseline Ludwig fibrosis stage as independent variables.|||21|-28|0.3884
72430546|NCT03890120|144371923|SUPERIORITY||Difference in LSM|-9.0||||0.039|TWO_SIDED|95.0|-20.0|1.0|||ANCOVA||The LSM, 95% CI and P-value (1-sided) were obtained by ANCOVA model to evaluate change at Week 96 as the dependent variable, baseline value of the outcome measure, baseline UDCA use, and baseline Ludwig fibrosis stage as independent variables.|||1|-20|0.0390
72430547|NCT03890120|144371924|SUPERIORITY||Difference in LSM|-2.6||||0.2845|TWO_SIDED|95.0|-11.6|6.4|||ANCOVA||The LSM, 95% CI and P-value (1-sided) were obtained by ANCOVA model to evaluate change at Week 96 as the dependent variable, baseline value of the outcome measure, baseline UDCA use, and baseline Ludwig fibrosis stage as independent variables.|||6.4|-11.6|0.2845
72430548|NCT03890120|144371925|SUPERIORITY||Difference in Percentages|4.1||||0.1978|TWO_SIDED|95.0|-5.3|13.5|||Mantel Haenszel||The difference between cilofexor and Placebo, 95% CI, and the p-value (1-sided) were obtained by the stratum-adjusted MH method, with baseline UDCA use and Ludwig fibrosis stage as stratification factors.|||13.5|-5.3|0.1978
72430549|NCT03890120|144371926|SUPERIORITY||Difference in Percentages|8.9||||0.0797|TWO_SIDED|95.0|-3.5|21.2|||Mantel Haenszel||The difference between cilofexor and Placebo, 95% CI, and the p-value (1-sided) were obtained by the stratum-adjusted MH method, with baseline UDCA use and Ludwig fibrosis stage as stratification factors.|||21.2|-3.5|0.0797
72430550|NCT03890120|144371927|SUPERIORITY||Difference in LSM|1.0||||0.7275|TWO_SIDED|95.0|-1.0|3.0|||ANCOVA||The LSM, 95% CI and P-value (1-sided) were obtained by ANCOVA model to evaluate change at Week 96 as the dependent variable, baseline value of the outcome measure, baseline UDCA use, and baseline Ludwig fibrosis stage as independent variables.|||3|-1|0.7275
72430551|NCT03890120|144371928|SUPERIORITY||Difference in LSM|-0.03||||0.3636|TWO_SIDED|95.0|-0.2|0.14|||ANCOVA||The LSM, 95% CI and P-value (1-sided) were obtained by ANCOVA model to evaluate change at Week 96 as the dependent variable, baseline value of the outcome measure, baseline UDCA use, and baseline Ludwig fibrosis stage as independent variables.|||0.14|-0.20|0.3636
72430552|NCT03890120|144371929|SUPERIORITY||Difference in LSM|-0.3||||0.3595|TWO_SIDED|95.0|-2.2|1.5|||ANCOVA||The LSM, 95% CI and P-value (1-sided) were obtained by ANCOVA model to evaluate change at Week 96 as the dependent variable, baseline value of the outcome measure, baseline UDCA use, and baseline Ludwig fibrosis stage as independent variables.|||1.5|-2.2|0.3595
72430553|NCT01925170|144371947|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||Comparison of the two groups for all densities, significant difference p ≤ 0.05.||||<0.001
72430554|NCT01925170|144371947|SUPERIORITY_OR_OTHER|||||||0.004|||||||t-test, 2 sided|||Comparison of two groups for all densities; significant difference p ≤ 0.05.||||0.004
72430555|NCT01925170|144371948|SUPERIORITY_OR_OTHER||||||<|0.001|||||||McNemar|||Significant difference p ≤ 0.05||||<0.001
72430556|NCT01925170|144371948|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||McNemar|||Significant difference p ≤ 0.05||||<0.0001
72430557|NCT01925170|144371949|SUPERIORITY_OR_OTHER||||||<|0.001|||||||McNemar|||Significant difference p ≤ 0.05||||< 0.001
72430558|NCT01925170|144371949|SUPERIORITY_OR_OTHER|||||||0.004|||||||McNemar|||Significant difference p ≤ 0.05||||0.004
72430559|NCT01925170|144371950|SUPERIORITY_OR_OTHER||||||<|0.001|||||||McNemar|||Significant difference p ≤ 0.05||||< 0.001
72430560|NCT01925170|144371950|SUPERIORITY_OR_OTHER||||||<|0.001|||||||McNemar|||Significant difference p ≤ 0.05||||<0.001
72430561|NCT01925170|144371951|SUPERIORITY_OR_OTHER||||||<|0.001|||||||McNemar|||Significant difference p ≤ 0.05||||<0.001
72430562|NCT01925170|144371951|SUPERIORITY_OR_OTHER||||||<|0.001|||||||McNemar|||Significant difference p ≤ 0.05||||<0.001
72430563|NCT00577720|144371952|SUPERIORITY_OR_OTHER||Ratio (LS Mean 35 mg DRFB/35 mg IRBB)|1.437|||||TWO_SIDED|90.0|1.091|1.964||||||For power calculations, assumed that variability in test treatment groups is no more than 50% higher than reference group. If true ratio of CTX is 0.65, the power to detect this departure from a ratio of 1.0 in the primary analysis is 0.88.||1.964|1.091|
72430564|NCT00577720|144371952|SUPERIORITY_OR_OTHER||Ratio (LS Mean 50 mg DRBB/35 mg IRBB)|1.507|||||TWO_SIDED|90.0|1.139|2.066||||||For power calculations, assumed that variability in test treatment groups is no more than 50% higher than reference group. If true ratio of CTX is 0.65, the power to detect this departure from a ratio of 1.0 in the primary analysis is 0.88.||2.066|1.139|
72430565|NCT00577720|144371952|SUPERIORITY_OR_OTHER||Ratio (LS Mean 50 mg DRFB/35 mg IRBB)|1.535|||||TWO_SIDED|90.0|1.177|2.086||||||For power calculations, assumed that variability in test treatment groups is no more than 50% higher than reference group. If true ratio of CTX is 0.65, the power to detect this departure from a ratio of 1.0 in the primary analysis is 0.88.||2.086|1.177|
72430566|NCT00577720|144371952|SUPERIORITY_OR_OTHER||Ratio (LS Mean 50 mg DRFB/50 mg DRBB)|1.068|||||TWO_SIDED|90.0|0.867|1.321||||||For power calculations, assumed that variability in test treatment groups is no more than 50% higher than reference group. If true ratio of CTX is 0.65, the power to detect this departure from a ratio of 1.0 in the primary analysis is 0.88.||1.321|0.867|
72430567|NCT00577720|144371952|SUPERIORITY_OR_OTHER||Ratio (LS Mean 50 mg DRFB/50 mg DRBB)|1.018|||||TWO_SIDED|90.0|0.824|1.267||||||For power calculations, assumed that variability in test treatment groups is no more than 50% higher than reference group. If true ratio of CTX is 0.65, the power to detect this departure from a ratio of 1.0 in the primary analysis is 0.88.||1.267|0.824|
72430568|NCT00577720|144371953|SUPERIORITY_OR_OTHER||Ratio (LS Mean 35 mg DRFB/35 mg IRBB)|1.208|||||TWO_SIDED|90.0|0.749|2.099||||||The target numbers of subjects assessable for the primary analysis are 70 in the 50 mg DRFB group and 35 in the 35 mg IRBB group. Sample sizes are determined to provide adequate power for the primary comparison (ie, serum CTX for 50 mg DRFB vs. 35 mg IRBB).||2.099|0.749|
72430569|NCT00577720|144371953|SUPERIORITY_OR_OTHER||Ratio (LS Mean 50 mg DRBB/35 mg IRBB)|1.132|||||TWO_SIDED|90.0|0.665|2.003||||||The target numbers of subjects assessable for the primary analysis are 70 in the 50 mg DRFB group and 35 in the 35 mg IRBB group. Sample sizes are determined to provide adequate power for the primary comparison (ie, serum CTX for 50 mg DRFB vs. 35 mg IRBB).||2.003|0.665|
72430570|NCT00577720|144371953|SUPERIORITY_OR_OTHER||Ratio (LS Mean 50 mg DRFB/35 mg IRBB)|1.407|||||TWO_SIDED|90.0|0.913|2.404||||||The target numbers of subjects assessable for the primary analysis are 70 in the 50 mg DRFB group and 35 in the 35 mg IRBB group. Sample sizes are determined to provide adequate power for the primary comparison (ie, serum CTX for 50 mg DRFB vs. 35 mg IRBB).||2.404|0.913|
72430571|NCT00577720|144371953|SUPERIORITY_OR_OTHER||Ratio (LS Mean 50 mg DRFB/35 mg DRFB)|1.165|||||TWO_SIDED|90.0|0.797|1.752||||||The target numbers of subjects assessable for the primary analysis are 70 in the 50 mg DRFB group and 35 in the 35 mg IRBB group. Sample sizes are determined to provide adequate power for the primary comparison (ie, serum CTX for 50 mg DRFB vs. 35 mg IRBB).||1.752|0.797|
72430572|NCT00577720|144371953|SUPERIORITY_OR_OTHER||Ratio (LS Mean 50 mg DRFB/50 mg DRBB)|1.243|||||TWO_SIDED|90.0|0.828|1.99||||||The target numbers of subjects assessable for the primary analysis are 70 in the 50 mg DRFB group and 35 in the 35 mg IRBB group. Sample sizes are determined to provide adequate power for the primary comparison (ie, serum CTX for 50 mg DRFB vs. 35 mg IRBB).||1.990|0.828|
72363677|NCT01684917|144238739|SUPERIORITY||||||<|0.05||||||calculated. The reported p-value was calculated, and is not attempting to indicate the threshold for statistical significance|t-test, 2 sided|||Baseline vs 12 weeks||||<0.05
72363678|NCT01684917|144238739|SUPERIORITY||||||<|0.05||||||calculated. The reported p-value was calculated, and is not attempting to indicate the threshold for statistical significance.|t-test, 2 sided|||Baseline vs 12 weeks||||<0.05
72430573|NCT00577720|144371954|SUPERIORITY_OR_OTHER||Ratio (LS Mean 35 mg DRFB/35 mg IRBB)|0.947|||||TWO_SIDED|90.0|0.316|2.993||||||The target numbers of subjects assessable for the primary analysis are 70 in the 50 mg DRFB group and 35 in the 35 mg IRBB group. Sample sizes are determined to provide adequate power for the primary comparison (ie, serum CTX for 50 mg DRFB vs. 35 mg IRBB).||2.993|0.316|
72430574|NCT00577720|144371954|SUPERIORITY_OR_OTHER||Ratio (LS Mean 50 mg DRBB/35 mg IRBB)|1.82|||||TWO_SIDED|90.0|0.929|5.429||||||The target numbers of subjects assessable for the primary analysis are 70 in the 50 mg DRFB group and 35 in the 35 mg IRBB group. Sample sizes are determined to provide adequate power for the primary comparison (ie, serum CTX for 50 mg DRFB vs. 35 mg IRBB).||5.429|0.929|
72430575|NCT00577720|144371954|SUPERIORITY_OR_OTHER||Ratio (LS Mean 50 mg DRFB/35 mg IRBB)|1.58|||||TWO_SIDED|90.0|0.801|4.718||||||The target numbers of subjects assessable for the primary analysis are 70 in the 50 mg DRFB group and 35 in the 35 mg IRBB group. Sample sizes are determined to provide adequate power for the primary comparison (ie, serum CTX for 50 mg DRFB vs. 35 mg IRBB).||4.718|0.801|
72430576|NCT00577720|144371954|SUPERIORITY_OR_OTHER||Ratio (LS Mean 50 mg DRFB/35 mg DRFB)|1.668|||||TWO_SIDED|90.0|0.856|4.668||||||The target numbers of subjects assessable for the primary analysis are 70 in the 50 mg DRFB group and 35 in the 35 mg IRBB group. Sample sizes are determined to provide adequate power for the primary comparison (ie, serum CTX for 50 mg DRFB vs. 35 mg IRBB).||4.668|0.856|
72430577|NCT00577720|144371954|SUPERIORITY_OR_OTHER||Ratio (LS Mean 50 mg DRFB/50 mgDRBB)|0.868|||||TWO_SIDED|90.0|0.504|1.488||||||The target numbers of subjects assessable for the primary analysis are 70 in the 50 mg DRFB group and 35 in the 35 mg IRBB group. Sample sizes are determined to provide adequate power for the primary comparison (ie, serum CTX for 50 mg DRFB vs. 35 mg IRBB).||1.488|0.504|
72430578|NCT03552978|144372031|SUPERIORITY||Odds Ratio (OR)|11.6|||<|0.001|TWO_SIDED||||||t-test, 2 sided|df - 63||||||<.001
72430579|NCT03552978|144372032|SUPERIORITY||Mean Difference (Final Values)|3.57|||<|0.001|TWO_SIDED||||||t-test, 2 sided|df = 59||||||<.001
72430580|NCT03552978|144372036|SUPERIORITY||Mean Difference (Final Values)|90.28||||0.39|TWO_SIDED||||||Mixed Models Analysis|df = 3, 152.11||We examined total Cigarettes smoked in the past 30 days using linear mixed models to account for non-independence (longitudinal data) and missing data. The null hypothesis was that the time by treatment group interaction would equal zero, indicating no difference in the change in cigarette use over time by treatment group.||||.39
72430581|NCT03552978|144372037|SUPERIORITY||Mean Difference (Final Values)|0.49||||0.91|TWO_SIDED||||||Mixed Models Analysis|df = 3, 140.87||We examined days of e-cigarette use in the previous 30 days using linear mixed models to account for non-independence (longitudinal data) and missing data. The null hypothesis was that the time by treatment group interaction would equal zero, indicating no difference in the change in e-cigarette use over time by treatment group.||||.91
72430582|NCT03552978|144372038|SUPERIORITY||Mean Difference (Final Values)|-0.18||||0.66|TWO_SIDED||||||Mixed Models Analysis|df = 3,199||We examined days of chewing tobacco use in the previous 30 days using linear mixed models to account for non-independence (longitudinal data) and missing data. The null hypothesis was that the time by treatment group interaction would equal zero, indicating no difference in the change in chewing tobacco use over time by treatment group.||||.66
72430583|NCT03552978|144372039|SUPERIORITY||Mean Difference (Final Values)|0.33||||0.76|TWO_SIDED||||||Mixed Models Analysis|df = 3, 102.04||We examined nicotine dependence using linear mixed models to account for non-independence (longitudinal data) and missing data. The null hypothesis was that the time by treatment group interaction would equal zero, indicating no difference in the change in nicotine dependence over time by treatment group.||||.76
72430584|NCT03552978|144372040|SUPERIORITY||Odds Ratio (OR)|1.99||||0.28|TWO_SIDED|||||Week 12|Chi-squared|df = 1||||||.28
72430585|NCT03552978|144372040|SUPERIORITY||Odds Ratio (OR)|2.3||||0.19|TWO_SIDED|||||Week 24|Chi-squared|df = 1||||||.19
72430586|NCT03552978|144372041|SUPERIORITY||Odds Ratio (OR)|1.68||||0.42|TWO_SIDED||||||Chi-squared|df = 1||Week 12||||.42
72430587|NCT03552978|144372041|SUPERIORITY||Odds Ratio (OR)|2.52||||0.17|TWO_SIDED||||||Chi-squared|df = 1||Week 24||||.17
72430588|NCT03552978|144372042|SUPERIORITY||Mean Difference (Final Values)|3.66||||0.58|TWO_SIDED||||||Mixed Models Analysis|df = 3, 100.51||We examined days of changes in PTSD symptoms using linear mixed models to account for non-independence (longitudinal data) and missing data. The null hypothesis was that the time by treatment group interaction would equal zero, indicating no difference in the change in PTSD symptoms over time by treatment group.||||.58
72430589|NCT01670500|144372045|OTHER||Risk Ratio (RR)|0.7|||||TWO_SIDED|90.0|0.39|1.2|||||The risk ratio is comparing cisplatin to doxorubicin-cyclophosphamide (AC)|||1.2|0.39|
72430590|NCT01670500|144372046|OTHER||Risk Ratio (RR)|0.73|||||TWO_SIDED|90.0|0.5|1.1|||||The risk ratio is comparing cisplatin to doxorubicin-cyclophosphamide (AC)|||1.1|.5|
72430591|NCT04951479|144372099|SUPERIORITY|||||||0.00041|||||||t-test, 2 sided|||Paired t-test of KOOS Pain score pre and 6 months post embolization||||0.00041
72430592|NCT04951479|144372100|SUPERIORITY|||||||0.008|||||||t-test, 2 sided|||||||0.008
72430593|NCT04951479|144372101|SUPERIORITY|||||||0.001|||||||t-test, 2 sided|||||||0.001
72430594|NCT04951479|144372102|SUPERIORITY|||||||0.00797|||||||t-test, 2 sided|paired t-test||||||0.00797
72430595|NCT01778062|144372114|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|||||||<0.0001
72430596|NCT04445155|144372118|SUPERIORITY|||||||0.125|||||||Wilcoxon Signed-Rank test|||"Null Hypothesis: The distributions of the scores are the same at baseline and immediately post-intervention.~Alternative Hypothesis: The distributions of the scores are different at baseline and immediately post-intervention."||||0.125
72430597|NCT04445155|144372120|SUPERIORITY|||||||0.011|||||||Paired t-test|||"Null Hypothesis: The means of the scores are the same at baseline and immediately post-intervention.~Alternative Hypothesis: The means of the scores are different at baseline and immediately post-intervention."||||0.011
72430598|NCT04445155|144372121|SUPERIORITY|||||||0.002|||||||Wilcoxon Signed-Rank test|||"Null Hypothesis: The distributions of the scores are the same at baseline and immediately post-intervention.~Alternative Hypothesis: The distributions of the scores are different at baseline and immediately post-intervention."||||0.002
72430599|NCT04445155|144372121|SUPERIORITY|||||||0.008|||||||Wilcoxon Signed-Rank test|||"Null Hypothesis: The distributions of the scores are the same at baseline and immediately post-intervention.~Alternative Hypothesis: The distributions of the scores are different at baseline and immediately post-intervention."||||0.008
72430600|NCT04445155|144372122|SUPERIORITY||||||<|0.001|||||||Wilcoxon Signed-Rank test|||"Null Hypothesis: The distributions of the scores are the same at baseline and immediately post-intervention.~Alternative Hypothesis: The distributions of the scores are different at baseline and immediately post-intervention."||||<0.001
72430601|NCT04445155|144372122|SUPERIORITY|||||||0.002|||||||Wilcoxon Signed-Rank test|||"Null Hypothesis: The distributions of the scores are the same at baseline and immediately post-intervention.~Alternative Hypothesis: The distributions of the scores are different at baseline and immediately post-intervention."||||0.002
72430602|NCT04445155|144372123|SUPERIORITY||||||<|0.001|||||||Wilcoxon Signed-Rank test|||"Null Hypothesis: The distributions of the scores are the same at baseline and immediately post-intervention.~Alternative Hypothesis: The distributions of the scores are different at baseline and immediately post-intervention."||||<0.001
72430603|NCT04445155|144372123|SUPERIORITY|||||||0.125|||||||Wilcoxon Signed-Rank test|||"Null Hypothesis: The distributions of the scores are the same at baseline and immediately post-intervention.~Alternative Hypothesis: The distributions of the scores are different at baseline and immediately post-intervention."||||0.125
72430604|NCT01875861|144372127|SUPERIORITY||Odds Ratio (OR)|1.19|||||TWO_SIDED|95.0|1.02|1.38||||||Because of data discontinuity, assumptions for time series analysis did not hold. Repeated measures regression models were developed to compare overall weight monitoring rates at baseline across the implementation phases.||1.38|1.02|
72430605|NCT01875861|144372128|SUPERIORITY||Odds Ratio (OR)|1.2|||||TWO_SIDED|95.0|1.03|1.39||||||See comments about time series analysis for primary outcome measure. Repeated measures regression analysis of the likelihood of monitoring for each time period was conducted.||1.39|1.03|
72430606|NCT01115998|144372189|SUPERIORITY_OR_OTHER|||||||0.02||||||The a priori alpha level was \< 0.10 and was not adjusted for multiple comparisons.|Wilcoxon Signed-Rank Test|||"Mobility functional skills~Null hypothesis: The change scores of children in the power mobility and control groups will not differ from baseline to 12 months."||||0.02
72430607|NCT01115998|144372189|SUPERIORITY_OR_OTHER|||||||0.52||||||The a priori alpha level was \<0.10 and was not adjusted for multiple comparisons|Wilcoxon Signed-Rank Test|||"Self-care functional skills~Null hypothesis: The change scores of children in the power mobility and control groups will not differ from baseline to 12 months."||||0.52
72430608|NCT01115998|144372189|SUPERIORITY_OR_OTHER|||||||0.38||||||The a priori alpha level was 0.10 and it was not adjusted for multiple comparisons.|Wilcoxon Signed-Rank Test|||"Social function functional skills~Null hypothesis: The change scores of children in the power mobility and control groups will not differ from baseline to 12 months."||||0.38
72430609|NCT01115998|144372189|SUPERIORITY_OR_OTHER|||||||0.03||||||The a priori alpha level was 0.10 and it was not adjusted for multiple comparisons.|Wilcoxon Signed-Rank Test|||"Mobility care giver assistance.~Null hypothesis: The change scores of children in the power mobility and control groups will not differ from baseline to 12 months."||||0.03
72430610|NCT01115998|144372189|SUPERIORITY_OR_OTHER|||||||0.006|||||||Wilcoxon Signed-Rank Test|The a priori alpha level was 0.10 and it was not adjusted for multiple comparisons.||"Self-care caregiver assistance~Null hypothesis: The change scores of children in the power mobility and control groups will not differ from baseline to 12 months."||||.006
72430611|NCT01115998|144372189|SUPERIORITY_OR_OTHER|||||||0.45||||||The a priori alpha level was \<0.10 and it was not adjusted for multiple comparisons.|Wilcoxon Signed-Rank Test|||"Social function caregiver assistance~Null hypothesis: The change scores of children in the power mobility and control groups will not differ from baseline to 12 months."||||0.45
72430612|NCT01115998|144372190|SUPERIORITY_OR_OTHER|||||||0.92||||||The a priori alpha level was \<0.10 and it was not adjusted for multiple comparisons.|Wilcoxon Signed-Rank Test|||"Adaptive total~Null hypothesis: The change scores of children in the power mobility and control groups will not differ from baseline to 12 months."||||0.92
72430613|NCT01115998|144372190|SUPERIORITY_OR_OTHER|||||||0.38||||||The a priori alpha level was \<0.10 and it was not adjusted for multiple comparisons.|Wilcoxon Signed-Rank Test|||"Cognitive total~Null hypothesis: The change scores of children in the power mobility and control groups will not differ from baseline to 12 months."||||0.38
72430614|NCT01115998|144372190|SUPERIORITY_OR_OTHER|||||||0.42||90.0||||The a priori alpha level was \<0.10 and it was not adjusted for multiple comparisons.|Wilcoxon Signed-Rank Test|||"Communication total~Null hypothesis: The change scores of children in the power mobility and control groups will not differ from baseline to 12 months."||||0.42
72430615|NCT01115998|144372190|SUPERIORITY_OR_OTHER|||||||0.57||||||The a priori alpha level was \<0.10 and it was not adjusted for multiple comparisons.|Wilcoxon Signed-Rank Test|||"Motor total~Null hypothesis: The change scores of children in the power mobility and control groups will not differ from baseline to 12 months."||||0.57
72430616|NCT01115998|144372190|SUPERIORITY_OR_OTHER|||||||0.69||||||The a priori alpha level was \<0.10 and it was not adjusted for multiple comparisons.|Wilcoxon Signed-Rank Test|||"Personal-social total~Null hypothesis: The change scores of children in the power mobility and control groups will not differ from baseline to 12 months."||||0.69
72430617|NCT01115998|144372190|SUPERIORITY_OR_OTHER|||||||0.28||||||The a priori alpha level was \<0.10 and it was not adjusted for multiple comparisons.|Wilcoxon Signed-Rank Test|||"BID total score~Null hypothesis: The change scores of children in the power mobility and control groups will not differ from baseline to 12 months."||||0.28
72363679|NCT01684917|144238740|SUPERIORITY|"Statistical Analysis was performed only for the Diet Arm/Group"|||||<|0.05||||||calculated. The reported p-value was calculated, and is not attempting to indicate the threshold for statistical significance|t-test, 2 sided|||"Baseline vs 12 weeks. Statistical Analysis was performed only for the Diet Arm/Group."||||<0.05
72430618|NCT01115998|144372191|SUPERIORITY_OR_OTHER||||||>|0.1|||||||Wilcoxon Signed-Rank Test|||"Reactive scale~Null hypothesis: The change scores of children in the power mobility and control groups will not differ from baseline to 12 months."||||>0.10
72430619|NCT01115998|144372191|SUPERIORITY_OR_OTHER||||||>|0.1|||||||Wilcoxon Signed-Rank Test|||"Self Initiated Scale~Null hypothesis: The change scores of children in the power mobility and control groups will not differ from baseline to 12 months."||||>0.10
72430620|NCT01268059|144372193|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|2.205||||0.027|TWO_SIDED|95.0|1.1|4.5|||Log Rank|The 2-sided p-value was calculated using the log-rank test stratified by histology, disease stage, and ECOG performance status.|Hazard ratio and its 95 percent (%) confidence interval ( CIs) were calculated using the Cox proportional hazard model stratified by histology, disease stage, and Eastern Cooperative Oncology Group (ECOG) performance status.|||4.5|1.1|0.027
72430621|NCT01268059|144372195|SUPERIORITY_OR_OTHER_LEGACY|||||||0.487||||||The 2-sided p-value was calculated by adjusting for the stratification factors histology, disease stage, and Eastern Cooperative Oncology Group (ECOG) performance status.|Cochran-Mantel-Haenszel|||Treatment effect Carboplatin/Paclitaxel + MEDI-575 versus Carboplatin/Paclitaxel.||||0.487
72430622|NCT01268059|144372195|SUPERIORITY_OR_OTHER_LEGACY|||||||0.386||||||The 2-sided p-value was calculated by adjusting for the stratification factors histology, disease stage, and ECOG performance status.|Cochran-Mantel-Haenszel|||Treatment effect Carboplatin/Paclitaxel + MEDI-575 versus Carboplatin/Paclitaxel.||||0.386
72430623|NCT01268059|144372198|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|3.017|||||TWO_SIDED|95.0|1.2|7.4|||||The 95% confidence interval calculated using the Cox proportional hazard model stratified by histology, disease stage, and ECOG performance status.|||7.4|1.2|
72430624|NCT01268059|144372198|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.134|||||TWO_SIDED|95.0|0.3|4.3|||||The 95% confidence interval calculated using the Cox proportional hazard model stratified by histology, disease stage, and ECOG performance status.|||4.3|0.3|
72430625|NCT01268059|144372199|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.315|||||TWO_SIDED|95.0|0.7|2.4|||||The 95% confidence interval calculated using the Cox proportional hazard model stratified by histology, disease stage, and ECOG performance status.|||2.4|0.7|
72430626|NCT01268059|144372199|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|2.083|||||TWO_SIDED|95.0|0.4|10.8|||||The 95% confidence interval calculated using the Cox proportional hazard model stratified by histology, disease stage, and ECOG performance status.|||10.8|0.4|
72430627|NCT02819479|144372212|OTHER||eta^2|0.37||||0.012|TWO_SIDED|||||The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|F(1,14) = 8.29||CHANGE IN VOLUME OF RADIATION NECROSIS: To explore durability of radiographic responses, we invoked a linear mixed model in which we addressed heterogeneity of time points by fitting the most appropriate model among compound symmetry, Huyhn-Felt structure, and an unstructured covariance matrix (multivariate analysis of variance).||||0.012
72430628|NCT02819479|144372212|OTHER||eta^2|0.19||||0.09|TWO_SIDED|||||The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|F(1,14) = 3.29||CHANGE IN VOLUME OF CEREBRAL EDEMA: To explore durability of radiographic responses, we invoked a linear mixed model in which we addressed heterogeneity of time points by fitting the most appropriate model among compound symmetry, Huyhn-Felt structure, and an unstructured covariance matrix (multivariate analysis of variance).||||0.09
72430629|NCT02819479|144372213|OTHER||eta^2|0.29||||0.02|TWO_SIDED|||||The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|F(5,34) = 2.74||To explore durability of clinical response, Migraine Disability Assessment (MIDAS) TOTAL SCORES were analyzed using a linear mixed model in which we addressed heterogeneity of time points by fitting the most appropriate model among compound symmetry, Huyhn Felt structure, and an unstructured covariance matrix (multivariate analysis of variance)||||0.02
72430630|NCT02819479|144372214|OTHER||eta^2|0.37||||0.019|TWO_SIDED|||||The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|F(5,34) = 3.17||To explore durability of clinical response, Migraine Disability Assessment (MIDAS) DAYS OF HEADACHE were analyzed using a linear mixed model in which we addressed heterogeneity of time points by fitting the most appropriate model among compound symmetry, Huyhn Felt structure, and an unstructured covariance matrix (multivariate analysis of variance).||||0.019
72430631|NCT02819479|144372215|OTHER||eta^2|0.3||||0.0006|TWO_SIDED|||||The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|F(5,35) = 3.96||To explore durability of clinical response, Migraine Disability Assessment (MIDAS) MIDAS PAIN LEVEL data were analyzed using a linear mixed model in which we addressed heterogeneity of time points by fitting the most appropriate model among compound symmetry, Huyhn Felt structure, and an unstructured covariance matrix (multivariate analysis of variance).||||0.0006
72430632|NCT02819479|144372216|OTHER||eta^2|0.3||||0.02|TWO_SIDED|||||The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|F(5, 35) = 2.98||To explore durability of clinical response, Headache Impact Test (HIT-6™) scores were analyzed using a linear mixed model in which we addressed heterogeneity of time points by fitting the most appropriate model among compound symmetry, Huyhn-Felt structure, and an unstructured covariance matrix (multivariate analysis of variance).||||0.02
72430633|NCT02819479|144372217|OTHER||eta^2|0.19||||0.23|TWO_SIDED|||||The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|F(2,14) = 1.62||To explore durability of clinical response, Karnofsky Performance Status Scale (KPS) data were analyzed using a linear mixed model in which we addressed heterogeneity of time points by fitting the most appropriate model among compound symmetry, Huyhn-Felt structure, and an unstructured covariance matrix (multivariate analysis of variance).||||0.23
72430634|NCT02819479|144372218|OTHER||Pearson's r|-0.199||||0.374|TWO_SIDED|||||The threshold for statistical significance was p \< 0.05.|Wilcoxon (Mann-Whitney)|Z = -0.889||Wilcoxon signed rank test (2-sided) was used to compare the total number of days on steroids in the 12 months prior versus the 12 months immediately following single dose IA Avastin (bevacizumab).||||0.374
72430635|NCT02819479|144372219|OTHER||partial eta^2|0.153||||0.66|TWO_SIDED|||||The threshold for statistical significance was p \< 0.05.|One way Repeat Meas ANOVA|F(2,5) = 0.451||DIGITS FORWARD: To explore post-operative change in Neurocognitive performance after intra-arterial bevacizumab, repeated measures ANOVA was performed for the DIGITS FORWARD variable across 3 time points (BL, 3 months, 12 months) where IQ was placed in the model as covariate.||||0.660
72430636|NCT02819479|144372219|OTHER||partial eta^2|0.602||||0.1|TWO_SIDED|||||The threshold for statistical significance was p \< 0.05.|One way Repeat Meas ANOVA|F(2,5) = 3.78||DIGITS BACKWARD: To explore post-operative change in Neurocognitive performance after intra-arterial bevacizumab, repeated measures ANOVA was performed for the DIGITS BACKWARD variable across 3 time points (BL, 3 months, 12 months) where IQ was placed in the model as covariate.||||0.100
72430637|NCT02819479|144372219|OTHER||partial eta^2|0.532||||0.149|TWO_SIDED|||||The threshold for statistical significance was p \< 0.05.|One way Repeat Meas ANOVA|F(2,5) = 2.847||NUMBERS \& LETTERS SPEED: To explore post-operative change in Neurocognitive performance after intra-arterial bevacizumab, repeated measures ANOVA was performed for the NUMBERS \& LETTERS SPEED variable across 3 time points (BL, 3 months, 12 months) where IQ was placed in the model as covariate.||||0.149
72430638|NCT02819479|144372219|OTHER||partial eta^2|0.721||||0.041|TWO_SIDED|||||The threshold for statistical significance was p \< 0.05.|One way Repeat Meas ANOVA|F(2,5) = 6.470||NUMBERS \& LETTERS ERRORS: To explore post-operative change in Neurocognitive performance after intra-arterial bevacizumab, repeated measures ANOVA was performed for the NUMBERS \& LETTERS ERRORS variable across 3 time points (BL, 3 months, 12 months) where IQ was placed in the model as covariate.||||0.041
72430639|NCT02819479|144372219|OTHER||partial eta^2|0.566||||0.124|TWO_SIDED||||||One way Repeat Meas ANOVA|F (2,5) = 3.256||NUMBERS \& LETTERS EFFICIENCY: To explore post-operative change in Neurocognitive performance after intra-arterial bevacizumab, repeated measures ANOVA was performed for the NUMBERS \& LETTERS EFFICIENCY variable across 3 time points (BL, 3 months, 12 months) where IQ was placed in the model as covariate.||||0.124
72430640|NCT02819479|144372219|OTHER||partial eta^2|0.042||||0.898|TWO_SIDED|||||The threshold for statistical significance was p \< 0.05.|One way Repeat Meas ANOVA|F(2,5) = 0.110||NAMING: To explore post-operative change in Neurocognitive performance after intra-arterial bevacizumab, repeated measures ANOVA was performed for the NAMING variable across 3 time points (BL, 3 months, 12 months) where IQ was placed in the model as covariate.||||0.898
72430641|NCT02819479|144372219|OTHER||partial eta^2|0.107||||0.754|TWO_SIDED|||||The threshold for statistical significance was p \< 0.05.|One way Repeat Meas ANOVA|F(2,5) = 0.299||LIST LEARNING LIST IMMEDIATE RECALL: To explore post-operative change in Neurocognitive performance after intra-arterial bevacizumab, repeated measures ANOVA was performed for the LIST LEARNING LIST IMMEDIATE RECALL variable across 3 time points (BL, 3 months, 12 months) where IQ was placed in the model as covariate.||||0.754
72430642|NCT02819479|144372219|OTHER||partial eta^2|0.751||||0.031|TWO_SIDED|||||The threshold for statistical significance was p \< 0.05.|One way Repeat Meas ANOVA|F(2,5) = 7.556||LIST LEARNING LIST LONG DELAYED RECALL: To explore post-operative change in Neurocognitive performance after intra-arterial bevacizumab, repeated measures ANOVA was performed for the LIST LEARNING LIST LONG DELAYED RECALL variable across 3 time points (BL, 3 months, 12 months) where IQ was placed in the model as covariate.||||0.031
72430643|NCT02819479|144372219|OTHER||partial eta^2|0.289||||0.426|TWO_SIDED|||||The threshold for statistical significance was p \< 0.05.|One way Repeat Meas ANOVA|F(2,5) = 1.018||SHAPE LEARNING IMMEDIATE RECOGNITION: To explore post-operative change in Neurocognitive performance after intra-arterial bevacizumab, repeated measures ANOVA was performed for the SHAPE LEARNING IMMEDIATE RECOGNITION variable across 3 time points (BL, 3 months, 12 months) where IQ was placed in the model as covariate.||||0.426
72430644|NCT02819479|144372219|OTHER||partial eta^2|0.361||||0.326|TWO_SIDED|||||The threshold for statistical significance was p \< 0.05.|One way Repeat Meas ANOVA|F(2,5) = 1.412||SHAPE LEARNING DELAYED RECOGNITION: To explore post-operative change in Neurocognitive performance after intra-arterial bevacizumab, repeated measures ANOVA was performed for the SHAPE LEARNING DELAYED RECOGNITION variable across 3 time points (BL, 3 months, 12 months) where IQ was placed in the model as covariate.||||0.326
72430645|NCT02819479|144372219|OTHER||partial eta^2|0.09||||0.79|TWO_SIDED|||||The threshold for statistical significance was p \< 0.05.|One way Repeat Meas ANOVA|F(2,5) = 0.247||STORY LEARNING PHRASE UNIT IMMEDIATE RECALL: To explore post-operative change in Neurocognitive performance after intra-arterial bevacizumab, repeated measures ANOVA was performed for the STORY LEARNING PHRASE UNIT IMMEDIATE RECALL variable across 3 time points (BL, 3 months, 12 months) where IQ was placed in the model as covariate.||||0.790
72430646|NCT02819479|144372219|OTHER||partial eta^2|0.239||||0.505|TWO_SIDED|||||The threshold for statistical significance was p \< 0.05.|One way Repeat Meas ANOVA|F(2,5) = 0.786||STORY LEARNING PHRASE UNIT DELAYED RECALL: To explore post-operative change in Neurocognitive performance after intra-arterial bevacizumab, repeated measures ANOVA was performed for the STORY LEARNING PHRASE UNIT DELAYED RECALL variable across 3 time points (BL, 3 months, 12 months) where IQ was placed in the model as covariate.||||0.505
72430647|NCT02819479|144372219|OTHER||partial eta^2|0.636||||0.08|TWO_SIDED|||||The threshold for statistical significance was p \< 0.05.|One way Repeat Meas ANOVA|F(2,5) = 4.362||DESIGN CONSTRUCTION: To explore post-operative change in Neurocognitive performance after intra-arterial bevacizumab, repeated measures ANOVA was performed for the DESIGN CONSTRUCTION variable across 3 time points (BL, 3 months, 12 months) where IQ was placed in the model as covariate.||||0.080
72430648|NCT02819479|144372219|OTHER||partial eta^2|0.693||||0.052|TWO_SIDED|||||The threshold for statistical significance was p \< 0.05.|One way Repeat Meas ANOVA|F(2,5) = 5.654||MAZES: To explore post-operative change in Neurocognitive performance after intra-arterial bevacizumab, repeated measures ANOVA was performed for the MAZES variable across 3 time points (BL, 3 months, 12 months) where IQ was placed in the model as covariate.||||0.052
72430649|NCT02819479|144372219|OTHER||partial eta^2|0.013||||0.968|TWO_SIDED|||||The threshold for statistical significance was p \< 0.05.|One way Repeat Meas ANOVA|F(2,5) = 0.033||CATEGORIES: To explore post-operative change in Neurocognitive performance after intra-arterial bevacizumab, repeated measures ANOVA was performed for the CATEGORIES variable across 3 time points (BL, 3 months, 12 months) where IQ was placed in the model as covariate.||||0.968
72430650|NCT02819479|144372219|OTHER||partial eta^2|0.261||||0.469|TWO_SIDED|||||The threshold for statistical significance was p \< 0.05.|One way Repeat Meas ANOVA|F(2,5) = 0.884||WORD GENERATION: To explore post-operative change in Neurocognitive performance after intra-arterial bevacizumab, repeated measures ANOVA was performed for the WORD GENERATION variable across 3 time points (BL, 3 months, 12 months) where IQ was placed in the model as covariate.||||0.469
72430651|NCT01646320|144372220|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.72|STANDARD_ERROR_OF_MEAN|0.0964|<|0.0001|TWO_SIDED|95.0|-0.91|-0.53||Tested at alpha=0.05|Longitudinal Repeated Measures Analysis|||||-0.53|-0.91|<0.0001
72430652|NCT01646320|144372221|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-27.5|STANDARD_ERROR_OF_MEAN|4.015|<|0.0001|TWO_SIDED|95.0|-35.4|-19.6||Secondary end points are tested following a sequential testing procedure at alpha=0.05|Longitudinal Repeated Measures Analysis|||||-19.6|-35.4|<0.0001
72430653|NCT01646320|144372222|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-35.5|STANDARD_ERROR_OF_MEAN|5.493|<|0.0001|TWO_SIDED|95.0|-46.3|-24.7||Secondary end points are tested following a sequential testing procedure at alpha=0.05|Longitudinal Repeated Measures Analysis|||||-24.7|-46.3|<0.0001
72430654|NCT01646320|144372223|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.5|STANDARD_ERROR_OF_MEAN|0.3126|<|0.0001|TWO_SIDED|95.0|-2.12|-0.89||Secondary endpoints are tested following a sequential testing procedure at alpha=0.05|Longitudinal Repeated Measures Analysis|||||-0.89|-2.12|<0.0001
72430655|NCT01646320|144372224|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|25.5|||<|0.0001|TWO_SIDED|95.0|16.7|34.4||Secondary end points are tested following a sequential testing procedure at alpha=0.05|Modified logistic regression|||||34.4|16.7|<0.0001
72430656|NCT05257837|144372242|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<.001
72430657|NCT05257837|144372243|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<.001
72430658|NCT05257837|144372244|SUPERIORITY|||||||0.012|||||||t-test, 2 sided|||||||.012
72430659|NCT05257837|144372246|SUPERIORITY|||||||0.217|||||||t-test, 2 sided|||||||.217
72430660|NCT05257837|144372247|SUPERIORITY|||||||0.745|||||||t-test, 2 sided|||||||.745
72430661|NCT04731714|144372254|SUPERIORITY|||||||0.0104|||||||Mixed Models Analysis|See publication for details||||||0.0104
72430662|NCT04731714|144372255|SUPERIORITY|||||||0.079|||||||Mixed Models Analysis|See publication for details||||||0.079
72430663|NCT04731714|144372256|SUPERIORITY|||||||0.9222|||||||Mixed Models Analysis|See publication for details||||||0.9222
72430664|NCT04731714|144372257|SUPERIORITY|||||||0.7995|||||||Mixed Models Analysis|See publication for details||||||0.7995
72430665|NCT04731714|144372258|OTHER|||||||0.314||||||rhythmic days|Friedman Test|See publication for further details||||||0.3140
72430666|NCT04731714|144372258|OTHER|||||||0.239||||||arrhythmic days|Friedman Test|See publication for further details||||||0.239
72430667|NCT04731714|144372262|SUPERIORITY|||||||0.8844|||||||Mixed Models Analysis|See publication for details||||||0.8844
72430668|NCT04731714|144372264|OTHER|||||||0.73|||||||binomial|One-sided||||||0.73
72430669|NCT02033993|144372291|SUPERIORITY||Hazard Ratio (HR)|0.92||||0.31|TWO_SIDED|90.0|0.68|1.23||1-sided p-value|Log Rank|||||1.23|0.68|0.31
72430670|NCT02033993|144372292|SUPERIORITY||Hazard Ratio (HR)|0.95||||0.4|TWO_SIDED|90.0|0.7|1.3||1-sided p-value|Log Rank|||||1.30|0.70|0.40
72430671|NCT02033993|144372293|SUPERIORITY||Odds Ratio (OR)|1.41||||0.28|TWO_SIDED|95.0|0.76|2.59|||Cochran-Mantel-Haenszel|||||2.59|0.76|0.28
72430672|NCT02033993|144372294|SUPERIORITY||Hazard Ratio (HR)|0.83||||0.54|TWO_SIDED|95.0|0.46|1.51|||Log Rank|||||1.51|0.46|0.54
72430673|NCT02724020|144372328|SUPERIORITY||Hazard Ratio (HR)|1.33|||=|0.388|TWO_SIDED|95.0|0.75|2.36|||Stratified Log-rank Test||HR obtained by stratified Cox proportion hazard model adjusted for prior lines of therapy and the international metastatic renal cell carcinoma database consortium risk category. A hazard ratio \< 1 indicated an advantage compared to Everolimus.|||2.36|0.75|=0.388
72430674|NCT02724020|144372328|SUPERIORITY||Hazard Ratio (HR)|1.37||||0.667|TWO_SIDED|95.0|0.75|2.52|||Stratified Log-rank Test||HR obtained by stratified Cox proportion hazard model adjusted for prior lines of therapy and the international metastatic renal cell carcinoma database consortium risk category. A hazard ratio \< 1 indicated an advantage compared to Everolimus.|||2.52|0.75|0.667
72430675|NCT02724020|144372330|SUPERIORITY||Hazard Ratio (HR)|1.76||||0.212|TWO_SIDED|95.0|0.89|3.49|||Stratified Log-rank Test||HR obtained by stratified Cox proportion hazard model adjusted for prior lines of therapy and the international metastatic renal cell carcinoma database consortium risk category. A hazard ratio \< 1 indicated an advantage compared to Everolimus.|||3.49|0.89|0.212
72430676|NCT02724020|144372330|SUPERIORITY||Hazard Ratio (HR)|1.51||||0.546|TWO_SIDED|95.0|0.77|2.98|||Stratified Log-rank Test||HR obtained by stratified Cox proportion hazard model adjusted for prior lines of therapy and the international metastatic renal cell carcinoma database consortium risk category. A hazard ratio \< 1 indicated an advantage compared to Everolimus.|||2.98|0.77|0.546
72430677|NCT02724020|144372331|SUPERIORITY||Hazard Ratio (HR)|1.57|||=|0.156|TWO_SIDED|95.0|0.81|3.05|||Log Rank||HR obtained by stratified Cox proportion hazard model adjusted for prior lines of therapy and the International Metastatic Renal Cell Carcinoma Database Consortium risk category. A hazard ratio \< 1 indicates an advantage compared to Everolimus.|||3.05|0.81|=0.156
72430678|NCT02724020|144372331|SUPERIORITY||Hazard Ratio (HR)|1.42||||0.667|TWO_SIDED|95.0|0.72|2.79|||Log Rank||HR obtained by stratified Cox proportion hazard model adjusted for prior lines of therapy and the International Metastatic Renal Cell Carcinoma Database Consortium risk category. A hazard ratio \< 1 indicates an advantage compared to Everolimus.|||2.79|0.72|0.667
72430679|NCT02724020|144372332|SUPERIORITY||Odds Ratio (OR)|0.41|||||TWO_SIDED|95.0|0.08|2.22|||||Odds ratio and 95% CI were obtained using a stratified CMH model with prior lines of therapy and the international metastatic renal cell carcinoma database consortium risk category.|As prespecified in the protocol, the statistical analysis was performed between arms - Arm A: Single-agent Everolimus 10 mg QD and Arm C: Combination of MLN0128 4 mg QD + MLN1117 200 mg QD only.|As prespecified in protocol, the statistical analysis was performed between arms - Arm A: Single-agent Everolimus 10 mg QD and Arm C: Combination of MLN0128 4 mg QD + MLN1117 200 mg QD only for this outcome measure.|2.22|0.08|
72430680|NCT02724020|144372333|SUPERIORITY||Odds Ratio (OR)|0.64|||||TWO_SIDED|95.0|0.24|1.69|||||Odds ratio and 95% CI was obtained using a stratified CMH model with prior lines of therapy and the international metastatic renal cell carcinoma database consortium risk category.|||1.69|0.24|
72430681|NCT02724020|144372333|SUPERIORITY||Odds Ratio (OR)|0.79|||||TWO_SIDED|95.0|0.28|2.21|||||Odds ratio and 95% CI was obtained using a stratified CMH model with prior lines of therapy and the international metastatic renal cell carcinoma database consortium risk category.|||2.21|0.28|
72430682|NCT02724020|144372334|SUPERIORITY||Odds Ratio (OR)|0.47|||||TWO_SIDED|95.0|0.16|1.38|||||Odds ratio and 95% CI was obtained using a stratified CMH model with prior lines of therapy and the international metastatic renal cell carcinoma database consortium risk category.|||1.38|0.16|
72430683|NCT02724020|144372334|SUPERIORITY||Odds Ratio (OR)|0.6|||||TWO_SIDED|95.0|0.2|1.8|||||Odds ratio and 95% CI was obtained using a stratified CMH model with prior lines of therapy and the international metastatic renal cell carcinoma database consortium risk category.|||1.80|0.20|
72430684|NCT04081298|144372354|EQUIVALENCE|feasibility assessment|Mean Difference (Final Values)|0.24|STANDARD_DEVIATION|0.8||0.24|TWO_SIDED|||||The threshold for statistical significance is p=0.05. (feasibility assessment)|Paired sample t-test|||||||0.24
72430685|NCT04081298|144372355|EQUIVALENCE|feasibility assessment|Mean Difference (Final Values)|0.14|STANDARD_DEVIATION|0.78||0.43|TWO_SIDED|||||The threshold for statistical significance was p=0.5 (feasibility assessment)|paired t-test|||||||0.43
72430686|NCT04081298|144372356|EQUIVALENCE|McNemar's test evaluates equivalence between nominal groups. Power not calculated as this is a feasibility study with small sample size.||||||0.1|||||||McNemar|||Single arm pre-post comparison at baseline and 3-month follow-up (feasibility study)||||0.10
72430687|NCT04081298|144372357|EQUIVALENCE|feasibility assessment|Mean Difference (Final Values)|0.2|STANDARD_DEVIATION|0.65||0.2|TWO_SIDED|||||The threshold for statistical significance was p=0.5 (feasibility assessment)|paired-sample t-test|||||||0.20
72430688|NCT04081298|144372358|EQUIVALENCE|paired sample t-test (feasibility assessment)|Mean Difference (Final Values)|0.06|STANDARD_DEVIATION|0.73||0.71|TWO_SIDED||||||paired sample t-test|||||||0.71
72430689|NCT04081298|144372359|EQUIVALENCE|The analysis is an equivalence analysis of change (H1) in mean value from baseline to 3 month follow-up. Power was not calculated for this analysis because this is a feasibility study. The sample size is not large enough to approach appropriate power.||||||0.94|||||||paired-sample t-test|||Single arm pre-post comparison at baseline and 3-month follow-up (feasibility study)||||0.94
72430690|NCT04081298|144372360|EQUIVALENCE|The analysis is an equivalence analysis of change (H1) in mean value from baseline to 3 month follow-up using a paired-sample t-test. Power was not calculated for this analysis because this is a feasibility study. The sample size is not large enough to approach appropriate power.||||||0.03|||||||paired-sample t-test|||||||0.03
72430691|NCT04081298|144372361|EQUIVALENCE|The analysis is an equivalence analysis of change (H1) in mean value from baseline to 3 month follow-up using a paired-sample t-test. Power was not calculated for this analysis because this is a feasibility study. The sample size is not large enough to approach appropriate power.||||||0.36|||||||paired-sample t-test|||||||0.36
72430692|NCT02059161|144372372|NON_INFERIORITY_OR_EQUIVALENCE|The criterion for declaring non-inferiority was for the upper bound of the 95% CI to lie below 0.4%.|Difference in the Least Squares Means|0.04|||||TWO_SIDED|95.0|-0.11|0.19|||||Longitudinal data analysis model included terms for treatment, time, prior insulin status (intermediate-acting, or long-acting insulin), and the interaction of time by treatment, and time by prior insulin status.|||0.19|-0.11|
72430693|NCT02059161|144372373|SUPERIORITY_OR_OTHER||Difference in the Percentages|-3.9|||||TWO_SIDED|95.0|-11.8|4.0|||||Miettinen \& Nurminen|||4.0|-11.8|
72430694|NCT02059161|144372374|SUPERIORITY_OR_OTHER||Difference in Percentages|-3.0|||||TWO_SIDED|95.0|-16.1|10.1|||||Miettinen \& Nurminen|||10.1|-16.1|
72363680|NCT01684917|144238741|SUPERIORITY|"Statistical Analysis was performed only for the Diet Arm/Group"|||||<|0.05||||||calculated. The reported p-value was calculated, and is not attempting to indicate the threshold for statistical significance.|t-test, 2 sided|||"Baseline vs 12 weeks. Statistical Analysis was performed only for the Diet Arm/Group."||||<0.05
72363681|NCT01684917|144238742|SUPERIORITY||||||<|0.05||||||The reported p-value was calculated, and is not attempting to indicate the threshold for statistical significance|t-test, 2 sided|||Baseline vs 12 weeks||||<0.05
72363682|NCT01684917|144238742|SUPERIORITY||||||<|0.05||||||The reported p-value was calculated, and is not attempting to indicate the threshold for statistical significance|t-test, 2 sided|||Baseline vs 12 weeks||||<0.05
72363683|NCT01684917|144238742|SUPERIORITY||||||<|0.05||||||The reported p-value was calculated, and is not attempting to indicate the threshold for statistical significance|t-test, 2 sided|||Baseline vs 12 weeks||||<0.05
72363684|NCT01684917|144238744|SUPERIORITY|"Statistical Analysis was performed only for the Diet Arm/Group"|||||<|0.05||||||calculated. The reported p-value was calculated, and is not attempting to indicate the threshold for statistical significance|t-test, 2 sided|||"Baseline vs 12 weeks. Statistical Analysis was performed only for the Diet Arm/Group."||||<0.05
72363685|NCT04659863|144238748|OTHER||Mean Difference (Net)|-33.25|||||TWO_SIDED|95.0|-59.17|-7.34||||||||-7.34|-59.17|
72363686|NCT02105740|144238770|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.67|STANDARD_DEVIATION|1.178||0.034|TWO_SIDED|95.0|0.224|5.11|||ANOVA|||The clinical significance was considered with a difference of 3 points on the Visual Analogue Scale (VAS) for both arms with a statistical power of 95%, significance level of 5%. Statistical analysis first compared the difference of means between hypnosis and control groups during three weeks.||5.110|0.224|0.034
72363687|NCT02105740|144238770|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.66|STANDARD_DEVIATION|0.856||0.004|TWO_SIDED|95.0|1.253|6.08|||ANOVA|||The clinical significance was considered with a difference of 3 points on the Visual Analogue Scale (VAS) with a statistical power of 95%, significance level of 5%. Statistical analysis compared the difference in pain average between the first and the second week in the hypnosis group.||6.080|1.253|0.004
72363688|NCT02105740|144238770|SUPERIORITY_OR_OTHER||Mean Difference (Net)|5.25|STANDARD_DEVIATION|0.827||0|TWO_SIDED|95.0|2.918|7.582|||ANOVA|||The clinical significance was considered with a difference of 3 points on the Visual Analogue Scale (VAS) with a statistical power of 95%, significance level of 5%. Statistical analysis compared the difference in pain average between the first and the third week in the hypnosis group.||7.582|2.918|0.000
72363689|NCT02105740|144238771|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.39|||||TWO_SIDED|||||||||Statistical analysis evaluated if the difference of averages of anxiety at the hypnosis and control groups in the third week.||||
72363690|NCT02105740|144238771|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.5|||||TWO_SIDED|||||||||Statistical analysis evaluated if the difference of averages of depression at the hypnosis and control groups in the third week.||||
72363691|NCT01353898|144238773|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.62|||||||||||||Geometric mean ratio of HIV-1/Healthy. Analyzed using a linear mixed model with fixed factors: dose, health-status and the interaction between dose and health-status.|Compared to historical data for AUC0-24hrs measured on Day 7 for healthy participants treated with 200 mg MK-1972 once daily||||
72363692|NCT01353898|144238773|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.84|||||||||||||Geometric mean ratio of HIV-1/Healthy. Analyzed using a linear mixed model with fixed factors: dose, health-status and the interaction between dose and health-status.|Compared to historical data for AUC0-24hrs measured on Day 7 for healthy participants treated with 800 mg MK-1972 once daily||||
72363693|NCT01353898|144238774|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9||||||||||||||||||
72363694|NCT01353898|144238774|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.54||||||||||||||||||
72363695|NCT01353898|144238774|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.99||||||||||||||||||
72430695|NCT02059161|144372377|SUPERIORITY_OR_OTHER||Difference in the Least Squares Means|-0.02|||||TWO_SIDED|95.0|-0.18|0.14|||||Longitudinal data analysis including terms for treatment, time, prior insulin status (intermediate-acting, or long-acting insulin), and the interaction of time by treatment, and time by prior insulin status.|||0.14|-0.18|
72363696|NCT01353898|144238774|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.53||||||||||||||||||
72363697|NCT01353898|144238774|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.83||||||||||||||||||
72363698|NCT04973449|144238809|NON_INFERIORITY|Noninferiority was demonstrated if the lower limit of the 2-sided 95% confidence interval (CI) of the GMT ratio of the comparator group and reference group was \> 0.67.|GMT ratio|1.19|||||TWO_SIDED|95.0|1.08|1.32||||||The analyses were derived using analysis of covariance (ANCOVA).||1.32|1.08|
72363699|NCT04973449|144238810|NON_INFERIORITY|Noninferiority was demonstrated if the lower limit of the 2-sided 95% CI of the GMT ratio of the comparator group and reference group is \> 0.67.|GMT ratio|1.02|||||TWO_SIDED|95.0|0.9|1.14||||||The analyses were derived using ANCOVA.||1.14|0.90|
72363700|NCT04973449|144238811|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI rate difference in seroresponse between the comparator group and reference group was \> or =-10%.|Seroresponse difference|1.68|||||TWO_SIDED|95.0|-3.11|6.49||||||The analyses were derived using ANCOVA.||6.49|-3.11|
72363701|NCT04973449|144238812|NON_INFERIORITY|Noninferiority was demonstrated if the lower limit of the 2-sided 95% CI of the GMT ratio of the comparator group and reference group is \> 0.67.|GMT ratio|3.47|||||TWO_SIDED|95.0|3.09|3.89||||||The analyses were derived using ANCOVA.||3.89|3.09|
72363702|NCT04973449|144238815|NON_INFERIORITY|Noninferiority was demonstrated if the lower limit of the 2-sided 95% CI of the GMT ratio of the comparator group and reference group was \> 0.67.|GMT ratio|3.21|||||TWO_SIDED|95.0|3.06|3.36||||||The analyses were derived using ANCOVA.||3.36|3.06|
72363703|NCT04973449|144238816|NON_INFERIORITY|Noninferiority was demonstrated if the lower limit of the 2-sided 95% CI of the GMT ratio of the comparator group and reference group was \> 0.67.|GMT ratio|0.5|||||TWO_SIDED|95.0|0.45|0.56||||||The analyses were derived using ANCOVA.||0.56|0.45|
72363704|NCT04973449|144238817|NON_INFERIORITY|Noninferiority was demonstrated if the lower limit of the 2-sided 95% CI of the GMT ratio of the comparator group and reference group was \> 0.67.|GMT ratio|0.31|||||TWO_SIDED|95.0|0.27|0.35||||||The analyses were derived using ANCOVA.||0.35|0.27|
72363705|NCT04973449|144238818|NON_INFERIORITY|Noninferiority was demonstrated if the lower limit of the 2-sided 95% CI of the GMT ratio of the comparator group and reference group was \> 0.67.|GMT ratio|1.41|||||TWO_SIDED|95.0|1.25|1.58||||||The analyses were derived using ANCOVA.||1.58|1.25|
72430696|NCT02059161|144372378|SUPERIORITY_OR_OTHER||Difference in the Least Squares Means|-1.77|||||TWO_SIDED|95.0|-4.69|1.16|||||Longitudinal data analysis including terms for treatment, time, prior insulin status (intermediate-acting, or long-acting insulin), and the interaction of time by treatment, and time by prior insulin status.|||1.16|-4.69|
72430697|NCT02059161|144372379|SUPERIORITY_OR_OTHER||Difference in the Least Squares Means|-0.02|||||TWO_SIDED|95.0|-0.06|0.01|||||Longitudinal data analysis including terms for treatment, time, prior insulin status (intermediate-acting, or long-acting insulin), and the interaction of time by treatment, and time by prior insulin status.|||0.01|-0.06|
72430698|NCT02059161|144372380|SUPERIORITY_OR_OTHER||Difference in the Least Squares Means|9.6|||||TWO_SIDED|95.0|-3.0|22.2|||||Longitudinal data analysis including terms for treatment, time, prior insulin status (intermediate-acting, or long-acting insulin), and the interaction of time by treatment, and time by prior insulin status.|||22.2|-3.0|
72430699|NCT02059161|144372381|SUPERIORITY_OR_OTHER||Differences in Percentages|-2.1|||||TWO_SIDED|95.0|-9.8|5.5|||||Miettinen \& Nurminen|||5.5|-9.8|
72430700|NCT02059161|144372382|SUPERIORITY_OR_OTHER||Difference in Percentages|0.8|||||TWO_SIDED|95.0|-12.8|14.3|||||Miettinen \& Nurminen|||14.3|-12.8|
72430701|NCT02059161|144372384|SUPERIORITY_OR_OTHER||Difference in the least squares means|-1.77|||||TWO_SIDED|95.0|-4.92|1.39|||||Longitudinal data analysis model included terms for treatment, time, prior insulin status (intermediate-acting, or long-acting insulin), and the interaction of time by treatment, and time by prior insulin status.|||1.39|-4.92|
72430702|NCT02059161|144372385|SUPERIORITY_OR_OTHER||Difference in the least squares means|-0.02|||||TWO_SIDED|95.0|-0.05|0.02|||||Longitudinal data analysis model included terms for treatment, time, prior insulin status (intermediate-acting, or long-acting insulin), and the interaction of time by treatment, and time by prior insulin status.|||0.02|-0.05|
72363706|NCT04973449|144238819|NON_INFERIORITY|Noninferiority was demonstrated if the lower limit of the 2-sided 95% CI of the GMT ratio of the comparator group and reference group was \> 0.67.|GMT ratio|1.84|||||TWO_SIDED|95.0|1.63|2.08||||||The analyses were derived using ANCOVA.||2.08|1.63|
72363707|NCT04973449|144238820|NON_INFERIORITY|Noninferiority was demonstrated if the lower limit of the 2-sided 95% CI of the GMT ratio of the comparator group and reference group was \> 0.67.|GMT ratio|0.88|||||TWO_SIDED|95.0|0.78|0.99||||||The analyses were derived using ANCOVA.||0.99|0.78|
72363708|NCT04973449|144238821|NON_INFERIORITY|Noninferiority was demonstrated if the lower limit of the 2-sided 95% CI of the GMT ratio of the comparator group and reference group was \> 0.67.|GMT ratio|0.87|||||TWO_SIDED|95.0|0.78|0.97||||||The analyses were derived using ANCOVA.||0.97|0.78|
72363709|NCT04973449|144238822|NON_INFERIORITY|Noninferiority was demonstrated if the lower limit of the 2-sided 95% CI of the GMT ratio of the comparator group and reference group was \> 0.67.|GMT ratio|0.95|||||TWO_SIDED|95.0|0.83|1.08||||||The analyses were derived using ANCOVA.||1.08|0.83|
72363710|NCT04973449|144238823|NON_INFERIORITY|Noninferiority was demonstrated if the lower limit of the 2-sided 95% CI of the GMT ratio of the comparator group and reference group was \> 0.67.|GMT ratio|6.56|||||TWO_SIDED|95.0|5.82|7.4||||||The analyses were derived using ANCOVA.||7.40|5.82|
72430703|NCT02059161|144372386|SUPERIORITY_OR_OTHER||Difference in the Least Squares Means|-5.4|||||TWO_SIDED|95.0|-19.7|8.9|||||Longitudinal data analysis including terms for treatment, time, prior insulin status (intermediate-acting, or long-acting insulin), and the interaction of time by treatment, and time by prior insulin status.|||8.9|-19.7|
72430704|NCT02059161|144372388|SUPERIORITY_OR_OTHER||Difference in the Least Squares Means|-0.4|||||TWO_SIDED|95.0|-8.9|8.2|||||Longitudinal data analysis model including terms for treatment, time, prior insulin status (intermediate-acting, or long-acting insulin), and the interaction of time by treatment, and time by prior insulin status.|||8.2|-8.9|
72430705|NCT02059161|144372389|SUPERIORITY_OR_OTHER||Difference in the Least Squares Means|-8.1|||||TWO_SIDED|95.0|-18.6|2.4|||||Longitudinal data analysis including terms for treatment, time, prior insulin status (intermediate-acting, or long-acting insulin), and the interaction of time by treatment, and time by prior insulin status.|||2.4|-18.6|
72363711|NCT04973449|144238824|NON_INFERIORITY|Noninferiority was demonstrated if the lower limit of the 2-sided 95% CI of the GMT ratio of the comparator group and reference group was \> 0.67.|GMT ratio|2.22|||||TWO_SIDED|95.0|1.99|2.47||||||The analyses were derived using ANCOVA.||2.47|1.99|
72363712|NCT04973449|144238825|NON_INFERIORITY|Noninferiority was demonstrated if the lower limit of the 2-sided 95% CI of the GMT ratio of the comparator group and reference group is \> 0.67.|GMT ratio|4.35|||||TWO_SIDED|95.0|3.86|4.9||||||The analyses were derived using ANCOVA.||4.90|3.86|
72363713|NCT04973449|144238826|NON_INFERIORITY|Noninferiority was demonstrated if the lower limit of the 2-sided 95% CI of the GMT ratio of the comparator group and reference group was \> 0.67.|GMT ratio|1.25|||||TWO_SIDED|95.0|1.13|1.39||||||The analyses were derived using ANCOVA.||1.39|1.13|
72363714|NCT04973449|144238827|NON_INFERIORITY|Noninferiority was demonstrated if the lower limit of the 2-sided 95% CI of the GMT ratio of the comparator group and reference group was \> 0.67.|GMT ratio|4.42|||||TWO_SIDED|95.0|3.85|5.08||||||The analyses were derived using ANCOVA.||5.08|3.85|
72363715|NCT04973449|144238828|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI rate difference in seroresponse between the comparator group and reference group was \> or =-10%.|Seroresponse difference|-1.24|||||TWO_SIDED|95.0|-6.62|3.84||||||The analyses were derived using ANCOVA.||3.84|-6.62|
72430706|NCT02059161|144372390|SUPERIORITY_OR_OTHER||Adjusted Difference in %s (A1C < 7.0%)|-0.8|||||TWO_SIDED|95.0|-9.7|8.1|||||Miettinen and Nurminen, stratified by prior insulin status.|||8.1|-9.7|
72363716|NCT04973449|144238829|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI rate difference in seroresponse between the comparator group and reference group was \> or =-10%.|Seroresponse difference|16.86|||||TWO_SIDED|95.0|10.18|23.32||||||The analyses were derived using ANCOVA.||23.32|10.18|
72363717|NCT04973449|144238830|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI rate difference in seroresponse between the comparator group and reference group was \> or =-10%.|Seroresponse difference|-18.12|||||TWO_SIDED|95.0|-24.22|-12.07||||||The analyses were derived using ANCOVA.||-12.07|-24.22|
72363718|NCT04973449|144238831|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI rate difference in seroresponse between the comparator group and reference group was \> or =-10%.|Seroresponse difference|-0.02|||||TWO_SIDED|95.0|-7.28|7.23||||||The analyses were derived using ANCOVA.||7.23|-7.28|
72430707|NCT02059161|144372390|SUPERIORITY_OR_OTHER||Adjusted Difference in %s (A1C <6.5%)|-1.1|||||TWO_SIDED|95.0|-8.6|6.5|||||Miettinen and Nurminen, stratified by prior insulin status.|||6.5|-8.6|
72430708|NCT02059161|144372391|SUPERIORITY_OR_OTHER||Adjusted Difference (A1C < 7.0%)|0.2|||||TWO_SIDED|95.0|-8.7|9.1|||||Miettinen and Nurminen|||9.1|-8.7|
72430709|NCT02059161|144372391|SUPERIORITY_OR_OTHER||Adjusted Difference (A1C < 6.5%)|-4.4|||||TWO_SIDED|95.0|-11.5|2.8|||||Miettinen and Nurminen|||2.8|-11.5|
72430710|NCT02059161|144372392|SUPERIORITY_OR_OTHER||Difference in Least Means Squares|-0.42|||||TWO_SIDED|95.0|-2.33|1.48|||||Longitudinal data analysis model included terms for treatment, time, prior insulin status (intermediate-acting, or long-acting insulin), and the interaction of time by treatment, and time by prior insulin status.|||1.48|-2.33|
72430711|NCT02059161|144372393|SUPERIORITY_OR_OTHER||Difference in Least Means Squares|0.0|||||TWO_SIDED|95.0|-0.02|0.02|||||Longitudinal data analysis model included terms for treatment, time, prior insulin status (intermediate-acting, or long-acting insulin), and the interaction of time by treatment, and time by prior insulin status.|||0.02|-0.02|
72430712|NCT02059161|144372394|SUPERIORITY_OR_OTHER||Difference in the Least Squares Means|-1.5|||||TWO_SIDED|95.0|-3.69|0.69|||||Longitudinal data analysis model included terms for treatment, time, prior insulin status (intermediate-acting, or long-acting insulin), and the interaction of time by treatment, and time by prior insulin status.|||0.69|-3.69|
72430713|NCT02059161|144372395|SUPERIORITY_OR_OTHER||Difference in the Least Squares Means|-0.02||||||95.0|-0.04|0.01|||||Longitudinal data analysis model included terms for treatment, time, prior insulin status (intermediate-acting, or long-acting insulin), and the interaction of time by treatment, and time by prior insulin status.|||0.01|-0.04|
72363719|NCT04973449|144238832|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI rate difference in seroresponse between the comparator group and reference group was \> or =-10%.|Seroresponse difference|31.36|||||TWO_SIDED|95.0|24.44|37.82||||||The analyses were derived using ANCOVA.||37.82|24.44|
72363720|NCT04973449|144238833|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI rate difference in seroresponse between the comparator group and reference group was \> or =-10%.|Seroresponse difference|-3.55|||||TWO_SIDED|95.0|-9.4|1.9||||||The analyses were derived using ANCOVA.||1.90|-9.40|
72430714|NCT02059161|144372396|SUPERIORITY_OR_OTHER||Difference in the Least Squares Means|-0.74|||||TWO_SIDED|95.0|-2.52|1.04|||||Longitudinal data analysis model included terms for treatment, time, prior insulin status (intermediate-acting, or long-acting insulin), and the interaction of time by treatment, and time by prior insulin status.|||1.04|-2.52|
72430715|NCT02059161|144372397|SUPERIORITY_OR_OTHER||Difference in the Least Squares Means|-0.01|||||TWO_SIDED|95.0|-0.03|0.01|||||Longitudinal data analysis model included terms for treatment, time, prior insulin status (intermediate-acting, or long-acting insulin), and the interaction of time by treatment, and time by prior insulin status.|||0.01|-0.03|
72430716|NCT02059161|144372398|SUPERIORITY_OR_OTHER||Difference in the Least Squares Means|-1.25|||||TWO_SIDED|95.0|-3.34|0.83|||||Longitudinal data analysis model included terms for treatment, time, prior insulin status (intermediate-acting, or long-acting insulin), and the interaction of time by treatment, and time by prior insulin status.|||0.83|-3.34|
72430717|NCT02059161|144372399|SUPERIORITY_OR_OTHER||Difference in the Least Squares Means|-0.02|||||TWO_SIDED|95.0|-0.04|0.01|||||Longitudinal data analysis model included terms for treatment, time, prior insulin status (intermediate-acting, or long-acting insulin), and the interaction of time by treatment, and time by prior insulin status.|||0.01|-0.04|
72430718|NCT02013687|144372419|SUPERIORITY_OR_OTHER||||||<|0.001||||||Significance of IgG values at study day 196 as compared to day 0 (pre-immune).|Wilcoxon (Mann-Whitney)|||||||<0.001
72430719|NCT02013687|144372419|SUPERIORITY_OR_OTHER||||||<|0.001||||||Significance of IgG values at study day 196 as compared to day 0 (pre-immune).|Wilcoxon (Mann-Whitney)|||||||<0.001
72430720|NCT02013687|144372420|SUPERIORITY_OR_OTHER|||||||0.8|||||||Wilcoxon (Mann-Whitney)|||||||0.8
72430721|NCT02013687|144372420|SUPERIORITY_OR_OTHER|||||||0.6|||||||Wilcoxon (Mann-Whitney)|||||||0.6
72430722|NCT02013687|144372421|SUPERIORITY_OR_OTHER|||||||0.5|||||||Wilcoxon (Mann-Whitney)|||||||0.5
72430723|NCT02013687|144372421|SUPERIORITY_OR_OTHER|||||||0.3|||||||Wilcoxon (Mann-Whitney)|||||||0.3
72430724|NCT01272011|144372428|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Two-way RMANOVA Student-Newman-Keuls|||Daily acute and cumulative Pre vs Post comparisons||||<0.001
72430725|NCT01272011|144372429|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||RMANOVA and Student-Neuman-Keuls|||Compared outcomes from Baseline versus Post-Day 10 IH for mean slope of AF vs. Resistance||||<0.05
72430726|NCT01272011|144372429|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||RMANOVA and Student-Neuman-Keuls|||Compared outcomes from Baseline versus Post-Day 10 IH for mean slope of of Pressure vs. Resistance||||<0.05
72430727|NCT01657032|144372430|NON_INFERIORITY_OR_EQUIVALENCE|The differences between the study groups were considered significant when the P value was \<0.05.||||||0.43|||||||Wilcoxon (Mann-Whitney)|||||||0.43
72430728|NCT03633903|144372441|SUPERIORITY||Mean Difference (Final Values)|1.04|||<|0.05|TWO_SIDED|||||"The reported p-value was calculated and is not indicating a threshold for significance.~This applies to the change from row 1 to row 3 (e.g., baseline pre TSST-C versus follow-up timepoint pre TSST-C)"|Mixed Models Analysis|||||||<.05
72430729|NCT03633903|144372441|SUPERIORITY||Mean Difference (Final Values)|0.77|||<|0.05|TWO_SIDED|||||"The reported p-value was calculated and is not indicating a threshold for significance.~This is for the difference from row 1 to row 2 (baseline pre versus baseline post TSST-C)"|Mixed Models Analysis|||||||<.05
72430730|NCT03633903|144372441|SUPERIORITY||Mean Difference (Final Values)|0.38||||0.4|TWO_SIDED|||||"The reported p-value was calculated and is not indicating a threshold for significance.~Comparing row 1 and row 4 (baseline pre TSST-C versus follow-up post TSST-C)."|Mixed Models Analysis|||||||0.40
72430731|NCT03633903|144372442|SUPERIORITY||Mean Difference (Final Values)|-0.35||||0.39|TWO_SIDED||||||Mixed Models Analysis|||Comparing group differences (CRP biomarker) in mindfulness versus control at baseline versus follow-up timepoints.||||.39
72430732|NCT03633903|144372442|SUPERIORITY||Mean Difference (Final Values)|-0.02||||0.95|TWO_SIDED||||||Mixed Models Analysis|||Comparing group differences (IL-6 biomarker) in mindfulness versus control at baseline versus follow-up timepoints.||||.95
72430733|NCT03633903|144372443|SUPERIORITY||Mean Difference (Final Values)|0.13||||0.08|TWO_SIDED|||||the calculated p value.|Mixed Models Analysis|||Comparing group differences (symptoms of anxiety/depression) in mindfulness versus control at baseline versus follow-up timepoints.||||.08
72363721|NCT04973449|144238834|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI rate difference in seroresponse between the comparator group and reference group was \> or =-10%.|Seroresponse difference|23.01|||||TWO_SIDED|95.0|15.41|30.23||||||The analyses were derived using ANCOVA.||30.23|15.41|
72363722|NCT04973449|144238835|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI rate difference in seroresponse between the comparator group and reference group was \> or =-10%.|Seroresponse difference|-34.24|||||TWO_SIDED|95.0|-40.77|-27.45||||||The analyses were derived using ANCOVA.||-27.45|-40.77|
72363723|NCT04973449|144238836|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI rate difference in seroresponse between the comparator group and reference group was \> or =-10%.|Seroresponse difference|6.96|||||TWO_SIDED|95.0|-1.31|15.1||||||The analyses were derived using ANCOVA.||15.10|-1.31|
72363724|NCT04973449|144238837|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI rate difference in seroresponse between the comparator group and reference group was \> or =-10%.|Seroresponse difference|29.05|||||TWO_SIDED|95.0|21.76|35.81||||||The analyses were derived using ANCOVA.||35.81|21.76|
72363725|NCT04973449|144238839|NON_INFERIORITY|Noninferiority was demonstrated if the lower limit of the 2-sided 95% CI of the GMT ratio of the comparator group and reference group was \> 0.67.|GMT ratio|1.36|||||TWO_SIDED|95.0|1.3|1.42||||||The analyses were derived using ANCOVA.||1.42|1.30|
72363726|NCT04973449|144238840|NON_INFERIORITY|Noninferiority was demonstrated if the lower limit of the 2-sided 95% CI of the GMT ratio of the comparator group and reference group was \> 0.67.|GMT ratio|0.76|||||TWO_SIDED|95.0|0.7|0.81||||||The analyses were derived using ANCOVA.||0.81|0.70|
72363727|NCT04973449|144238841|NON_INFERIORITY|Noninferiority was demonstrated if the lower limit of the 2-sided 95% CI of the GMT ratio of the comparator group and reference group was \> 0.67.|GMT ratio|3.87|||||TWO_SIDED|95.0|3.4|4.39||||||The analyses were derived using ANCOVA.||4.39|3.40|
72363728|NCT04973449|144238842|NON_INFERIORITY|Noninferiority was demonstrated if the lower limit of the 2-sided 95% CI of the GMT ratio of the comparator group and reference group was \> 0.67.|GMT ratio|0.67|||||TWO_SIDED|95.0|0.64|0.7||||||The analyses were derived using ANCOVA.||0.70|0.64|
72363729|NCT04973449|144238843|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI rate difference in seroresponse between the comparator group and reference group was \> or =-10%.|Seroresponse difference|0.58|||||TWO_SIDED|95.0|-0.61|2.09||||||The analyses were derived using ANCOVA.||2.09|-0.61|
72363730|NCT04973449|144238844|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI rate difference in seroresponse between the comparator group and reference group was \> or =-10%.|Seroresponse difference|-35.18|||||TWO_SIDED|95.0|-41.46|-28.44||||||The analyses were derived using ANCOVA.||-28.44|-41.46|
72363731|NCT04973449|144238845|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI rate difference in seroresponse between the comparator group and reference group was \> or =-10%.|Seroresponse difference|-24.93|||||TWO_SIDED|95.0|-31.06|-18.56||||||The analyses were derived using ANCOVA.||-18.56|-31.06|
72363732|NCT04973449|144238846|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI rate difference in seroresponse between the comparator group and reference group was \> or =-10%.|Seroresponse difference|-0.02|||||TWO_SIDED|95.0|-1.63|1.56||||||The analyses were derived using ANCOVA.||1.56|-1.63|
72363733|NCT04973449|144238847|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI rate difference in seroresponse between the comparator group and reference group was \> or =-10%.|Seroresponse difference|-19.18|||||TWO_SIDED|95.0|-23.8|-14.98||||||The analyses were derived using ANCOVA.||-14.98|-23.80|
72363734|NCT04973449|144238848|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI rate difference in seroresponse between the comparator group and reference group was \> or =-10%.|Seroresponse difference|39.18|||||TWO_SIDED|95.0|32.68|45.21||||||The analyses were derived using ANCOVA.||45.21|32.68|
72363735|NCT04973449|144238849|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI rate difference in seroresponse between the comparator group and reference group was \> or =-10%.|Seroresponse difference|0.0|||||TWO_SIDED|95.0|-1.62|1.62||||||The analyses were derived using ANCOVA.||1.62|-1.62|
72363736|NCT04973449|144238850|NON_INFERIORITY|Noninferiority was demonstrated if the lower limit of the 2-sided 95% CI of the GMT ratio of the comparator group and reference group was \> 0.67.|GMT ratio|0.52|||||TWO_SIDED|95.0|0.45|0.59||||||The analyses were derived using ANCOVA.||0.59|0.45|
72363737|NCT04973449|144238851|NON_INFERIORITY|Noninferiority was demonstrated if the lower limit of the 2-sided 95% CI of the GMT ratio of the comparator group and reference group was \> 0.67.|GMT ratio|0.76|||||TWO_SIDED|95.0|0.68|0.86||||||The analyses were derived using ANCOVA.||0.86|0.68|
72363738|NCT04973449|144238852|NON_INFERIORITY|Noninferiority was demonstrated if the lower limit of the 2-sided 95% CI of the GMT ratio of the comparator group and reference group was \> 0.67.|GMT ratio|1.6|||||TWO_SIDED|95.0|1.43|1.79||||||The analyses were derived using ANCOVA.||1.79|1.43|
72363739|NCT04973449|144238853|NON_INFERIORITY|Noninferiority was demonstrated if the lower limit of the 2-sided 95% CI of the GMT ratio of the comparator group and reference group was \> 0.67.|GMT ratio|0.75|||||TWO_SIDED|95.0|0.67|0.85||||||The analyses were derived using ANCOVA.||0.85|0.67|
72363740|NCT04973449|144238854|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI rate difference in seroresponse between the comparator group and reference group was \> or =-10%.|Seroresponse difference|-18.1|||||TWO_SIDED|95.0|-24.13|-12.1||||||The analyses were derived using ANCOVA.||-12.10|-24.13|
72363741|NCT04973449|144238855|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI rate difference in seroresponse between the comparator group and reference group was \> or =-10%.|Seroresponse difference|14.5|||||TWO_SIDED|95.0|7.07|21.71||||||The analyses were derived using ANCOVA.||21.71|7.07|
72363742|NCT04973449|144238856|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI rate difference in seroresponse between the comparator group and reference group was \> or =-10%.|Seroresponse difference|-18.1|||||TWO_SIDED|95.0|-24.13|-12.1||||||The analyses were derived using ANCOVA.||-12.10|-24.13|
72430734|NCT02300311|144372483|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.849|STANDARD_ERROR_OF_MEAN|0.306|<|0.0001|TWO_SIDED|95.0|-2.454|-1.244||The model included the fixed, categorical effects of treatment, country, time and treatment-by-time interaction and the continuous covariate of baseline PI.|REML based repeated measures approach|restricted maximum likelihood (REML) based repeated measures approach|Differences between the treatment group effects (Finalgon® cream - placebo).|"PID8 utilised a restricted maximum likelihood (REML) based repeated measures approach, using all available longitudinal pain intensity observations at each post-baseline time up to 8 hours.~The statistical model was applied to the analysis of change from baseline in pain intensity at 0.5, 1, 2, 3, 4, 6 and 8 hours."||-1.244|-2.454|<0.0001
72430735|NCT02300311|144372484|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.341|STANDARD_ERROR_OF_MEAN|0.248|<|0.0001|TWO_SIDED|95.0|-1.832|-0.851||The statistical model included the fixed, categorical effects of treatment, country, time and treatment-by-time interaction and the continuous covariate of baseline PI.|REML based repeated measures approach|restricted maximum likelihood (REML) based repeated measures approach|Differences between the treatment group effects (Finalgon® cream - placebo)|"PID4 utilised a restricted maximum likelihood (REML) based repeated measures approach, using all available longitudinal pain intensity observations at each post-baseline time up to 4 hours.~The statistical model was applied to the analysis of change from baseline in pain intensity at 0.5, 1, 2, 3, and 4 hours."||-0.851|-1.832|<0.0001
72430736|NCT02300311|144372485|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.958|STANDARD_ERROR_OF_MEAN|0.381|<|0.0001|TWO_SIDED|95.0|-3.712|-2.205|||ANCOVA|ANCOVA using the fixed, categorical effects of treatment and country as well as the continuous covariate of baseline PI.|Differences between the treatment group effects (Finalgon® cream - placebo)|The difference of average pain intensity from pre-dose baseline on the last individual treatment day was analysed using ANCOVA.||-2.205|-3.712|<0.0001
72430737|NCT02300311|144372486|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|11.37|||<|0.0001|TWO_SIDED|95.0|5.342|24.199|||Regression, Logistic|Ordinal logistic regression models adjusting for the continuous covariate 'baseline PI' and the categorical variable 'country' was performed.|Odds ratio of (Finalgon® cream / placebo)|"For the analysis of the repeated multinomial efficacy endpoint 'patient assessment of efficacy' on the last individual treatment day, ordinal logistic regression models is used.~Only non-missing data is analysed in the statistical model."||24.199|5.342|<0.0001
72430738|NCT01656759|144372499|SUPERIORITY_OR_OTHER|||||||0.2|TWO_SIDED||||||t-test, 2 sided|||||||0.2
72430739|NCT01656759|144372500|SUPERIORITY_OR_OTHER|||||||0.9|TWO_SIDED||||||t-test, 2 sided|||||||0.9
72363743|NCT04973449|144238857|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI rate difference in seroresponse between the comparator group and reference group was \> or =-10%.|Seroresponse difference|16.87|||||TWO_SIDED|95.0|10.15|23.4||||||The analyses were derived using ANCOVA.||23.40|10.15|
72430740|NCT01656759|144372502|SUPERIORITY_OR_OTHER|||||||0.9|TWO_SIDED||||||t-test, 2 sided|||||||0.9
72430741|NCT02531438|144372505|NON_INFERIORITY|A non-inferiority margin of 10% was used for the analysis.|treatment difference|-1.6|||||TWO_SIDED|95.0|-7.1|3.8|||||The 95% confidence interval was constructed based on the Miettinen and Nurminen method without stratification. Treatment difference for a response of clinical success was calculated as omadacycline minus moxifloxacin.|||3.8|-7.1|
72430742|NCT02531438|144372506|NON_INFERIORITY|A non-inferiority margin of 10% was used for the analysis.|treatment difference|2.5|||||TWO_SIDED|95.0|-2.4|7.4|||||The 95% confidence interval was constructed based on the Miettinen and Nurminen method without stratification. Treatment difference for a response of clinical success was calculated as omadacycline minus moxifloxacin.|||7.4|-2.4|
72363744|NCT04973449|144238858|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI rate difference in seroresponse between the comparator group and reference group was \> or =-10%.|Seroresponse difference|0.0|||||TWO_SIDED|95.0|-7.21|7.21||||||The analyses were derived using ANCOVA.||7.21|-7.21|
72363745|NCT04973449|144238859|NON_INFERIORITY|Noninferiority was demonstrated if the lower limit of the 2-sided 95% CI of the GMT ratio of the comparator group and reference group was \> 0.67.|GMT ratio|2.0|||||TWO_SIDED|95.0|1.75|2.28||||||The analyses were derived using ANCOVA.||2.28|1.75|
72430743|NCT02531438|144372507|NON_INFERIORITY|A non-inferiority margin of 10% was used for the analysis.|treatment difference|2.5|||||TWO_SIDED|95.0|-1.7|6.8|||||The 95% confidence interval was constructed based on the Miettinen and Nurminen method without stratification. Treatment difference for a response of clinical success was calculated as omadacycline minus moxifloxacin.|||6.8|-1.7|
72430744|NCT00811187|144372538|SUPERIORITY|\[Not Specified\]|Mean Difference (Net)|-2.03|||<|0.001|TWO_SIDED||||||Regression, Linear||Treatment pain difference= Lidocaine (0.97) - Placebo (3.00).|A sample size calculation and power analysis was conducted using PS Power and Sample Size Calculations 2.1.30 (Vanderbilt University, Department of Biostatistics, Nashville, TN) to determine necessary sample size.||||<.001
72430745|NCT00994279|144372631|SUPERIORITY_OR_OTHER_LEGACY|||||||0.53|TWO_SIDED||||||Chi-squared|||Null hypothesis is that the two arms will not differ in retention at 14 weeks.||||.53
72430746|NCT00994279|144372632|SUPERIORITY_OR_OTHER_LEGACY|||||||0.98|TWO_SIDED||||||Mixed Models Analysis|||Null hypothesis is that the two groups would not differ in fatigue at 10 weeks.||||.98
72430747|NCT01606189|144372633|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-0.58||||0.005|TWO_SIDED|95.0|-0.98|-0.18|||ANOVA|||Box Scale-11 pain scores were compared between treatment groups using an analysis of variance (ANOVA). The model included factors for patient, treatment and period. The significance of the overall treatment effect was assessed using the F-test from the ANOVA. The model used was as follows: Box Scale-11 Pain Score = Patient + Treatment + Period||-0.18|-0.98|0.005
72430748|NCT01606189|144372633|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-0.64||||0.002|TWO_SIDED|95.0|-1.03|-0.24|||ANOVA|||Box Scale-11 pain scores were compared between treatment groups using an ANOVA. The model included factors for patient, treatment and period. The significance of the overall treatment effect was assessed using the F-test from the ANOVA. The model used was as follows: Box Scale-11 Pain Score = Patient + Treatment + Period||-0.24|-1.03|0.002
72430749|NCT01606189|144372634|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-0.2||||0.017|TWO_SIDED|95.0|-0.37|-0.04|||ANOVA|||Sleep disturbance scores were compared between treatment groups using ANOVA. The model included factors for patient, treatment and period. The significance of the overall treatment effect was assessed using the F-test from the ANOVA. The model used was as follows: Sleep disturbance Score = Patient + Treatment + Period||-0.04|-0.37|0.017
72430750|NCT01606189|144372634|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-0.33|||<|0.001|TWO_SIDED|95.0|-0.49|-0.16|||ANOVA|||Sleep disturbance scores were compared between treatment groups using ANOVA. The model included factors for patient, treatment and period. The significance of the overall treatment effect was assessed using the F-test from the ANOVA. The model used was as follows: Sleep disturbance Score = Patient + Treatment + Period||-0.16|-0.49|<0.001
72430751|NCT01606189|144372635|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|0.55||||0.019|TWO_SIDED|95.0|0.09|1.01|||ANOVA|||Sleep quality scores were compared between treatment groups using ANOVA. The model included factors for patient, treatment and period. The significance of the overall treatment effect was assessed using the F-test from the ANOVA. The model used was as follows: Sleep Quality Score = Patient + Treatment + Period||1.01|0.09|0.019
72430752|NCT01606189|144372635|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|0.79||||0.001|TWO_SIDED|95.0|0.33|1.24|||ANOVA|||Sleep quality scores were compared between treatment groups using ANOVA. The model included factors for patient, treatment and period. The significance of the overall treatment effect was assessed using the F-test from the ANOVA. The model used was as follows: Sleep Quality Score = Patient + Treatment + Period||1.24|0.33|0.001
72430753|NCT01606189|144372636|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-1.55||||0.146|TWO_SIDED|95.0|-3.64|0.55|||ANOVA|||Total pain intensity scores were compared between treatment groups using ANOVA. The model included factors for patient, treatment and period. The significance of the overall treatment effect was assessed using the F-test from the ANOVA. The model used was as follows: Total Pain Intensity Score = Patient + Treatment + Period||0.55|-3.64|0.146
72430754|NCT01606189|144372636|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-2.2||||0.04|TWO_SIDED|95.0|-4.29|-0.1|||ANOVA|||Total pain intensity scores were compared between treatment groups using ANOVA. The model included factors for patient, treatment and period. The significance of the overall treatment effect was assessed using the F-test from the ANOVA. The model used was as follows: Total Pain Intensity Score = Patient + Treatment + Period||-0.10|-4.29|0.040
72430755|NCT01606189|144372637|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-7.28||||0.092|TWO_SIDED|95.0|-15.78|1.21|||ANOVA|||Intensity of Pain scores were compared between treatment groups using ANOVA. The model included factors for patient, treatment and period. The significance of the overall treatment effect was assessed using the F-test from the ANOVA. The model used was as follows: Intensity of Pain Score = Patient + Treatment + Period||1.21|-15.78|0.092
72430756|NCT01606189|144372637|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-8.99||||0.037|TWO_SIDED|95.0|-17.41|-0.57|||ANOVA|||Intensity of Pain scores were compared between treatment groups using ANOVA. The model included factors for patient, treatment and period. The significance of the overall treatment effect was assessed using the F-test from the ANOVA. The model used was as follows: Intensity of Pain Score = Patient + Treatment + Period||-0.57|-17.41|0.037
72430757|NCT01606189|144372638|SUPERIORITY_OR_OTHER_LEGACY||Mann-Whitney U statistic|1222.0||||0.328||95.0|||||Wilcoxon (Mann-Whitney)|||Pain at present was analysed using the Mann-Whitney test with a correction for ties. Results were presented in terms of the sums of the ranks for the two groups, the Mann-Whitney U statistic and the associated p-value.||||0.328
72430758|NCT01606189|144372638|SUPERIORITY_OR_OTHER_LEGACY||Mann-Whitney U statistic|1200.5||||0.56||95.0|||||Wilcoxon (Mann-Whitney)|||Pain at present was analysed using the Mann-Whitney test with a correction for ties. Results were presented in terms of the sums of the ranks for the two groups, the Mann-Whitney U statistic and the associated p-value.||||0.560
72430759|NCT01606189|144372639|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-1.75||||0.181|TWO_SIDED|95.0|-4.32|0.83|||ANOVA|||Pain Disability Index scores were compared between treatment groups using ANOVA. The model included factors for patient, treatment and period. The significance of the overall treatment effect was assessed using the F-test from the ANOVA. The model used was as follows: Pain Disability Index Score = Patient + Treatment + Period||0.83|-4.32|0.181
72430760|NCT01606189|144372639|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|0.43||||0.739|TWO_SIDED|95.0|-2.12|2.98|||ANOVA|||Pain Disability Index scores were compared between treatment groups using ANOVA. The model included factors for patient, treatment and period. The significance of the overall treatment effect was assessed using the F-test from the ANOVA. The model used was as follows: Pain Disability Index Score = Patient + Treatment + Period||2.98|-2.12|0.739
72430761|NCT01606189|144372640|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-2.23||||0.015|TWO_SIDED|95.0|-4.01|-0.45|||ANOVA|||12-Item General Health Questionnaire scores were compared between treatment groups using ANOVA. The model included factors for patient, treatment and period. The significance of the overall treatment effect was assessed using the F-test from the ANOVA. The model used was as follows: 12-Item General Health Questionnaire Score = Patient + Treatment + Period||-0.45|-4.01|0.015
72430762|NCT01606189|144372640|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-1.21||||0.178|TWO_SIDED|95.0|-2.97|0.56|||ANOVA|||12-Item General Health Questionnaire scores were compared between treatment groups using ANOVA. The model included factors for patient, treatment and period. The significance of the overall treatment effect was assessed using the F-test from the ANOVA. The model used was as follows: 12-Item General Health Questionnaire Score = Patient + Treatment + Period||0.56|-2.97|0.178
72430763|NCT00162942|144372642|SUPERIORITY_OR_OTHER|||||||0.858|||||||Fisher Exact|||||||.858
72430764|NCT00162942|144372644|SUPERIORITY_OR_OTHER|||||||0.813||95.0|||||Student's t-test|||||||0.813
72430765|NCT00162942|144372645|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|||||||1.000
72430766|NCT00162942|144372646|SUPERIORITY_OR_OTHER|||||||0.67||95.0|||||Student's t-test|||||||0.670
72430767|NCT00162942|144372647|SUPERIORITY_OR_OTHER|||||||0.977||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.977
72430768|NCT00162942|144372648|SUPERIORITY_OR_OTHER|||||||0.67||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.670
72430769|NCT00162942|144372649|SUPERIORITY_OR_OTHER|||||||0.17||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.170
72430770|NCT00162942|144372650|SUPERIORITY_OR_OTHER|||||||0.0773||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0773
72430771|NCT00162942|144372651|SUPERIORITY_OR_OTHER|||||||0.261||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.261
72430772|NCT00162942|144372652|SUPERIORITY_OR_OTHER|||||||0.379||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.379
72430773|NCT00162942|144372653|SUPERIORITY_OR_OTHER|||||||0.441||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.441
72430774|NCT00162942|144372654|SUPERIORITY_OR_OTHER|||||||0.759||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.759
72430775|NCT00162942|144372655|SUPERIORITY_OR_OTHER|||||||0.222||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.222
72430776|NCT00162942|144372656|SUPERIORITY_OR_OTHER|||||||0.256||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.256
72430777|NCT00162942|144372657|SUPERIORITY_OR_OTHER|||||||0.87||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.870
72430778|NCT00162942|144372658|SUPERIORITY_OR_OTHER|||||||0.35||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.350
72430779|NCT00162942|144372659|SUPERIORITY_OR_OTHER|||||||0.0632||95.0|||||Fisher Exact|||||||0.0632
72430780|NCT00162942|144372659|SUPERIORITY_OR_OTHER|||||||0.0504||95.0|||||Fisher Exact (Mid-P-Value)|||||||0.0504
72430781|NCT00162942|144372660|SUPERIORITY_OR_OTHER|||||||0.8265||95.0|||||Fisher Exact|||||||0.8265
72430782|NCT00162942|144372661|SUPERIORITY_OR_OTHER|||||||0.0676||95.0|||||Fisher Exact|||||||0.0676
72430783|NCT00162942|144372661|SUPERIORITY_OR_OTHER|||||||0.0506||95.0|||||Fisher Exact (Mid-P-Value)|||||||0.0506
72430784|NCT00162942|144372662|SUPERIORITY_OR_OTHER|||||||0.8721||95.0|||||Fisher Exact|||||||0.8721
72363746|NCT04973449|144238860|NON_INFERIORITY|Noninferiority was demonstrated if the lower limit of the 2-sided 95% CI of the GMT ratio of the comparator group and reference group was \> 0.67.|GMT ratio|2.96|||||TWO_SIDED|95.0|2.64|3.32||||||The analyses were derived using ANCOVA.||3.32|2.64|
72430785|NCT00162942|144372663|SUPERIORITY_OR_OTHER|||||||0.0289||95.0|||||Fisher Exact|||||||0.0289
72430786|NCT00162942|144372664|SUPERIORITY_OR_OTHER|||||||0.8618||95.0|||||Fisher Exact|||||||0.8618
72430787|NCT01167023|144372671|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-11.26||||0.304||95.0||||Pain rate was analyzed using an analysis of covariance (ANCOVA) model, with baseline pain intensity, treatment group, and stratification variable sickle-cell genotype as explanatory variables.|ANCOVA||Least Squares (LS) Mean Difference is for 5 mg prasugrel minus placebo.|||||0.304
72430788|NCT01167023|144372673|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-24.051|||<|0.001||95.0||||A mixed-effects model repeated measures analysis with baseline measurement, stratification variable sickle cell genotype, treatment, time, and time\*treatment interaction as fixed effects, and participant as a random effect in the model was used.|Mixed Models Analysis||Least Squares Mean Difference is for 5 mg prasugrel minus placebo.|||||<0.001
72430789|NCT01167023|144372674|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.56||||0.244||95.0||||Average pain intensity was analyzed using an analysis of covariance (ANCOVA) model, with baseline intensity, treatment group and stratification variable sickle-cell genotype as explanatory variables.|ANCOVA||Least Squares (LS) Mean Difference is for 5 mg prasugrel minus placebo.|||||0.244
72430790|NCT01167023|144372675|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-128.3|||<|0.001||95.0||||A mixed-effects model repeated measures analysis with baseline measurement, stratification variable sickle cell genotype, treatment, time and time\*treatment interaction as fixed effects, and participant as a random effect in the model.|Mixed Models Analysis||Least Squares (LS) Mean Difference is for 5 mg prasugrel minus placebo.|||||<0.001
72430791|NCT02049437|144372676|SUPERIORITY||Risk Ratio (RR)|4.43||||0.07|TWO_SIDED|95.0|0.9|21.83|||Mixed Models Analysis|||||21.83|0.90|0.07
72430792|NCT02049437|144372677|SUPERIORITY||Mean Difference (Final Values)|-2036.8|||<|0.001|TWO_SIDED|95.0|-3490.32|-900.62|||Wilcoxon (Mann-Whitney)|||||-900.62|-3490.32|<0.001
72430793|NCT02049437|144372678|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.77|TWO_SIDED|95.0|-0.79|0.65|||Wilcoxon (Mann-Whitney)|||||0.65|-0.79|0.77
72430794|NCT04213846|144372699|SUPERIORITY|Generalized linear mixed model was estimated using a sample of N=408 with a Condition × 1-Month Follow-Up interaction. Assessment-only control was the reference category for Condition, and Baseline was the reference category for 1-Month Follow-Up.|Count/Rate Ratio|0.94||||0.34|TWO_SIDED|95.0|0.81|1.07|||Generalized linear mixed model|Models controlled for sex, age, and college type (2-year vs. 4-year) and used a Poisson error distribution.||Changes from Baseline to 1-Month Follow-Up for intervention versus assessment-only control reported in this section.||1.07|0.81|0.34
72430795|NCT04213846|144372699|SUPERIORITY|Generalized linear mixed model was estimated using a sample of N=408 with a Condition × 6-Month Follow-Up interaction. Assessment-only control was the reference category for Condition, and Baseline was the reference category for 6-Month Follow-Up.|Count/Rate Ratio|1.09||||0.37|TWO_SIDED|95.0|0.91|1.3|||Generalized linear mixed model|Models controlled for sex, age, and college type (2-year vs. 4-year) and used a Poisson error distribution.||Changes from Baseline to 6-Month Follow-Up for intervention versus assessment-only control reported in this section.||1.30|0.91|0.37
72430796|NCT04213846|144372699|SUPERIORITY|Generalized linear mixed model was estimated using a sample of N=408 with a Condition × 12-Month Follow-Up interaction. Assessment-only control was the reference category for Condition, and Baseline was the reference category for 12-Month Follow-Up.|Count/Rate Ratio|1.02||||0.8|TWO_SIDED|95.0|0.85|1.23|||Generalized linear mixed model|Models controlled for sex, age, and college type (2-year vs. 4-year) and used a Poisson error distribution.||Changes from Baseline to 12-Month Follow-Up for intervention versus assessment-only control reported in this section.||1.23|0.85|0.80
72430797|NCT04213846|144372700|SUPERIORITY|Generalized linear mixed model was estimated using a sample of N=408 with a Condition × 1-Month Follow-Up interaction. Assessment-only control was the reference category for Condition, and Baseline was the reference category for 1-Month Follow-Up.|Count/Rate Ratio|1.02||||0.75|TWO_SIDED|95.0|0.88|1.2|||Generalized linear mixed model|Models controlled for sex, age, college type and used a Poisson error distribution. Peak eBAC multiplied by 100 and rounded up to the nearest integer.||Changes from Baseline to 1-Month Follow-Up for intervention versus assessment-only control reported in this section.||1.20|0.88|0.75
72430798|NCT04213846|144372700|SUPERIORITY|Generalized linear mixed model was estimated using a sample of N=408 with a Condition × 6-Month Follow-Up interaction. Assessment-only control was the reference category for Condition, and Baseline was the reference category for 6-Month Follow-Up.|Count/Rate Ratio|1.04||||0.72|TWO_SIDED|95.0|0.86|1.25|||Generalized linear mixed model|Models controlled for sex, age, college type and used a Poisson error distribution. Peak eBAC multiplied by 100 and rounded up to the nearest integer.||Changes from Baseline to 6-Month Follow-Up for intervention versus assessment-only control reported in this section.||1.25|0.86|0.72
72430799|NCT04213846|144372700|SUPERIORITY|Generalized linear mixed model was estimated using a sample of N=408 with a Condition × 12-Month Follow-Up interaction. Assessment-only control was the reference category for Condition, and Baseline was the reference category for 12-Month Follow-Up.|Count/Rate Ratio|1.01||||0.91|TWO_SIDED|95.0|0.85|1.21|||Generalized linear mixed model|Models controlled for sex, age, college type and used a Poisson error distribution. Peak eBAC multiplied by 100 and rounded up to the nearest integer.||Changes from Baseline to 12-Month Follow-Up for intervention versus assessment-only control reported in this section.||1.21|0.85|0.91
72430800|NCT04213846|144372701|SUPERIORITY|Generalized linear mixed model was estimated using a sample of N=408 with a Condition × 1-Month Follow-Up interaction. Assessment-only control was the reference category for Condition, and Baseline was the reference category for 1-Month Follow-Up.|Count/Rate Ratio|0.83||||0.04|TWO_SIDED|95.0|0.69|0.99|||Generalized linear mixed model|Models controlled for sex, age, and college type (2-year vs. 4-year) and used a Poisson error distribution.||Changes from Baseline to 1-Month Follow-Up for intervention versus assessment-only control reported in this section.||0.99|0.69|0.04
72430801|NCT04213846|144372701|SUPERIORITY|Generalized linear mixed model was estimated using a sample of N=408 with a Condition × 6-Month Follow-Up interaction. Assessment-only control was the reference category for Condition, and Baseline was the reference category for 6-Month Follow-Up.|Count/Rate Ratio|0.98||||0.84|TWO_SIDED|95.0|0.77|1.23|||Generalized linear mixed model|Models controlled for sex, age, and college type (2-year vs. 4-year) and used a Poisson error distribution.||Changes from Baseline to 6-Month Follow-Up for intervention versus assessment-only control reported in this section.||1.23|0.77|0.84
72430802|NCT04213846|144372701|SUPERIORITY|Generalized linear mixed model was estimated using a sample of N=408 with a Condition × 12-Month Follow-Up interaction. Assessment-only control was the reference category for Condition, and Baseline was the reference category for 12-Month Follow-Up.|Count/Rate Ratio|0.9||||0.34|TWO_SIDED|95.0|0.73|1.22|||Generalized linear mixed model|Models controlled for sex, age, and college type (2-year vs. 4-year) and used a Poisson error distribution.||Changes from Baseline to 12-Month Follow-Up for intervention versus assessment-only control reported in this section.||1.22|0.73|0.34
72430803|NCT04213846|144372702|SUPERIORITY|Generalized linear mixed model was estimated using a sample of N=408 with a Condition × 1-Month Follow-Up interaction. Assessment-only control was the reference category for Condition, and Baseline was the reference category for 1-Month Follow-Up.|Count/Rate Ratio|0.98||||0.78|TWO_SIDED|95.0|0.82|1.16|||Generalized linear mixed model|Models controlled for sex, age, and college type (2-year vs. 4-year) and used a Poisson error distribution.||Changes from Baseline to 1-Month Follow-Up for intervention versus assessment-only control reported in this section.||1.16|0.82|0.78
72430804|NCT04213846|144372702|SUPERIORITY|Generalized linear mixed model was estimated using a sample of N=408 with a Condition × 6-Month Follow-Up interaction. Assessment-only control was the reference category for Condition, and Baseline was the reference category for 6-Month Follow-Up.|Count/Rate Ratio|0.9||||0.27|TWO_SIDED|95.0|0.75|1.08|||Generalized linear mixed model|Models controlled for sex, age, and college type (2-year vs. 4-year) and used a Poisson error distribution.||Changes from Baseline to 6-Month Follow-Up for intervention versus assessment-only control reported in this section.||1.08|0.75|0.27
72430805|NCT04213846|144372702|SUPERIORITY|Generalized linear mixed model was estimated using a sample of N=408 with a Condition × 12-Month Follow-Up interaction. Assessment-only control was the reference category for Condition, and Baseline was the reference category for 12-Month Follow-Up.|Count/Rate Ratio|1.01||||0.95|TWO_SIDED|95.0|0.84|1.2|||Generalized linear mixed model|Models controlled for sex, age, and college type (2-year vs. 4-year) and used a Poisson error distribution.||Changes from Baseline to 12-Month Follow-Up for intervention versus assessment-only control reported in this section.||1.20|0.84|0.95
72430806|NCT04213846|144372703|SUPERIORITY|Generalized linear model was estimated using a sample of N=346.|Count/Rate Ratio|0.98||||0.69|TWO_SIDED|95.0|0.89|1.08|||Generalized linear mixed model|Model controlled for sex, age, and college type (2-year vs. 4-year) and used a negative binomial error distribution.||Changes from Baseline to 12-Month Follow-Up for intervention versus assessment-only control reported in this section.||1.08|0.89|0.69
72430807|NCT03850444|144372726|OTHER||Hazard Ratio (HR)|0.62|||||TWO_SIDED|95.0|0.38|1.0|||||Hazard ratio based on Cox regression model with treatment as a covariate stratified by ECOG PS (0 vs. 1), and histology (squamous vs. non-squamous).|||1.00|0.38|
72430808|NCT03850444|144372727|OTHER||Hazard Ratio (HR)|0.62|||||TWO_SIDED|95.0|0.41|0.95|||||Hazard ratio based on Cox regression model with treatment as a covariate stratified by ECOG PS (0 vs. 1), PD-L1 expression status (TPS=≥50% vs. TPS=1-49%), and histology (squamous vs. non-squamous).|||0.95|0.41|
72430809|NCT03850444|144372728|OTHER||Hazard Ratio (HR)|0.65|||||TWO_SIDED|95.0|0.45|0.94|||||Hazard ratio based on Cox regression model with treatment as a covariate stratified by ECOG PS (0 vs. 1), PD-L1 expression status (TPS=≥50% vs. TPS=1-49%), and histology (squamous vs. non-squamous).|||0.94|0.45|
72430810|NCT03850444|144372729|OTHER||Hazard Ratio (HR)|0.85|||||TWO_SIDED|95.0|0.57|1.28|||||Hazard ratio based on Cox regression model with treatment as a covariate stratified by ECOG PS (0 vs. 1), and histology (squamous vs. non-squamous).|||1.28|0.57|
72430811|NCT03850444|144372730|OTHER||Hazard Ratio (HR)|0.99|||||TWO_SIDED|95.0|0.7|1.39|||||Hazard ratio based on Cox regression model with treatment as a covariate stratified by ECOG PS (0 vs. 1), PD-L1 expression status (TPS=≥50% vs. TPS=1-49%), and histology (squamous vs. non-squamous).|||1.39|0.70|
72430812|NCT03850444|144372731|OTHER||Hazard Ratio (HR)|1.0|||||TWO_SIDED|95.0|0.74|1.35|||||Hazard ratio based on Cox regression model with treatment as a covariate stratified by ECOG PS (0 vs. 1), PD-L1 expression status (TPS=≥50% vs. TPS=1-49%), and histology (squamous vs. non-squamous).|||1.35|0.74|
72430813|NCT03850444|144372732|OTHER||Difference in Percentage (DP)|17.2|||||TWO_SIDED|95.0|1.8|31.6|||Stratified Miettinen and Nurminen||DP for pembrolizumab vs. chemotherapy based on Miettinen \& Nurminen method stratified by ECOG PS (0 vs. 1) and histology (squamous vs. non-squamous).|||31.6|1.8|
72430814|NCT03850444|144372733|OTHER||Difference in Percentage (DP)|11.3|||||TWO_SIDED|95.0|-1.4|23.7|||||DP for pembrolizumab vs. chemotherapy based on Miettinen \& Nurminen method stratified by ECOG PS (0 vs. 1), PD-L1 expression status (TPS=≥50% vs. TPS=1-49%), and histology (squamous vs. non-squamous).|||23.7|-1.4|
72430815|NCT03850444|144372734|OTHER||Difference in Percentage (DP)|8.0|||||TWO_SIDED|95.0|-3.0|18.9|||||DP for pembrolizumab vs. chemotherapy based on Miettinen \& Nurminen method stratified by ECOG PS (0 vs. 1), PD-L1 expression status (TPS=≥50% vs. TPS=1-49%), and histology (squamous vs. non-squamous).|||18.9|-3.0|
72430816|NCT05310084|144372752|NON_INFERIORITY|Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (coadministration group to separate-administration group) was greater than 0.67.|GMR|0.83|||||TWO_SIDED|95.0|0.77|0.89|||||GMRs and 95% CIs were calculated by exponentiating LSmeans difference of logarithms of concentrations (coadmin group-separate admin group), corresponding CIs based on analysis of log transformed assay results using a linear regression model.|||0.89|0.77|
72430817|NCT05310084|144372753|NON_INFERIORITY|Noninferiority was declared for an influenza strain if the lower bound of the 2-sided 95% CI for the GMR (coadministration group to separate administration group) was greater than 0.67|Geometric Mean Ratio|0.89|||||TWO_SIDED|95.0|0.77|1.04|||||GMRs and 95% CIs were calculated by exponentiating LSmeans difference of logarithms of titers (coadministration group-separate administration group), corresponding CIs based on analysis of log transformed assay results using a linear regression model|B/Austria||1.04|0.77|
72430818|NCT05310084|144372753|NON_INFERIORITY|Noninferiority was declared for an influenza strain if the lower bound of the 2-sided 95% CI for the GMR (coadministration group to separate administration group) was greater than 0.67.|GMR|1.0|||||TWO_SIDED|95.0|0.89|1.13|||||GMRs and 95% CIs were calculated by exponentiating LSmeans difference of logarithms of titers (coadministration group-separate administration group), corresponding CIs based on analysis of log transformed assay results using a linear regression model|B/Phuket||1.13|0.89|
72430819|NCT05310084|144372753|NON_INFERIORITY|Noninferiority was declared for an influenza strain if the lower bound of the 2-sided 95% CI for the GMR (coadministration group to separate administration group) was greater than 0.67.|GMR|0.95|||||TWO_SIDED|95.0|0.83|1.09|||||GMRs and 95% CIs were calculated by exponentiating LSmeans difference of logarithms of titers (coadministration group-separate administration group), corresponding CIs based on analysis of log transformed assay results using a linear regression model|H1N1 A/Victoria||1.09|0.83|
72430820|NCT05310084|144372753|NON_INFERIORITY|Noninferiority was declared for an influenza strain if the lower bound of the 2-sided 95% CI for the GMR (coadministration group to separate administration group) was greater than 0.67.|GMR|0.96|||||TWO_SIDED|95.0|0.85|1.09|||||GMRs and 95% CIs were calculated by exponentiating LSmeans difference of logarithms of titers (coadministration group-separate administration group), corresponding CIs based on analysis of log transformed assay results using a linear regression model|H3N2 A/Darwin||1.09|0.85|
72430821|NCT02107274|144372776|SUPERIORITY_OR_OTHER||||||<|0.01||||||P value of less than 0.05 was considered as significant.|t-test, 1 sided|||"Sputum volume were compared between Visit 6 (Week 12) and Visit 3 (Baseline), Visit 8 (Week 24) and Visit 3 (Baseline), as well for Visit 8 (Week 24) and Visit 6 (Week 12).~Independent t-test was applied for study end points which were numerical variables."||||<0.01
72430822|NCT02107274|144372776|SUPERIORITY_OR_OTHER||||||<|0.01||||||P value of less than 0.05 was considered significant.|t-test, 1 sided|||"Sputum volume were compared between Visit 6 (Week 12) and Visit 3 (Baseline), Visit 8 (Week 24) and Visit 3 (Baseline), as well for Visit 8 (Week 24) and Visit 6 (Week 12).~Independent t-test was applied for study end points which were numerical variables."||||<0.01
72430823|NCT02107274|144372777|SUPERIORITY_OR_OTHER||||||<|0.01||||||P value of less than 0.05 was considered as significant.|t-test, 1 sided|||"SGRQ scores were compared between Visit 6 (Week 12) and Visit 3 (Baseline), Visit 8 (Week 24) and Visit 3 (Baseline), as well for Visit 8 (Week 24) and Visit 6 (Week 12).~Independent t-test was applied for study end points which were numerical variables."||||<0.01
72430824|NCT02107274|144372777|SUPERIORITY_OR_OTHER||||||<|0.01||||||p valu of less than 0.05 was considered significant.|t-test, 1 sided|||"SGRQ scores were compared between Visit 6 (Week 12) and Visit 3 (Baseline), Visit 8 (Week 24) and Visit 3 (Baseline), as well for Visit 8 (Week 24) and Visit 6 (Week 12).~Independent t-test was applied for study end points which were numerical variables"||||<0.01
72430825|NCT02107274|144372778|SUPERIORITY_OR_OTHER||||||<|0.01||||||P value of less than 0.05 was considered as significant.|t-test, 1 sided|||"FEV1 values were compared between Visit 6 (Week 12) and Visit 3 (Baseline), Visit 8 (Week 24) and Visit 3 (Baseline), as well for Visit 8 (Week 24) and Visit 6 (Week 12).~Independent t-test was applied for study end points which were numerical variables."||||<0.01
72430826|NCT02107274|144372778|SUPERIORITY_OR_OTHER||||||<|0.01||||||p value of less than 0.05 was considered significant|t-test, 1 sided|||"FEV1 values were compared between Visit 6 (Week 12) and Visit 3 (Baseline), Visit 8 (Week 24) and Visit 3 (Baseline), as well for Visit 8 (Week 24) and Visit 6 (Week 12).~Independent t-test was applied for study end points which were numerical variables."||||<0.01
72430827|NCT02107274|144372779|SUPERIORITY_OR_OTHER||||||<|0.01||||||P value of less than 0.05 was considered as significant.|t-test, 1 sided|||"FVC values were compared between Visit 6 (Week 12) and Visit 3 (Baseline), Visit 8 (Week 24) and Visit 3 (Baseline), as well for Visit 8 (Week 24) and Visit 6 (Week 12).~Independent t-test was applied for study end points which were numerical variables."||||<0.01
72430828|NCT02107274|144372779|SUPERIORITY_OR_OTHER||||||<|0.01||||||p value of less than 0.05 was considered significant.|t-test, 1 sided|||"FVC values were compared between Visit 6 (Week 12) and Visit 3 (Baseline), Visit 8 (Week 24) and Visit 3 (Baseline), as well for Visit 8 (Week 24) and Visit 6 (Week 12).~Independent t-test was applied for study end points which were numerical variables."||||<0.01
72430829|NCT02941146|144372780|OTHER||sucess proportion|64.3|||||TWO_SIDED|95.0|35.1|87.2||||||||87.2|35.1|
72430830|NCT02424344|144372803|SUPERIORITY_OR_OTHER||Least Square mean difference|-0.125||||0.069|TWO_SIDED|95.0|-0.259|0.01|||ANCOVA|Adjusted by baseline and age as covariates, and treatment group, sex and smoking-status as fixed effect factors||||0.010|-0.259|0.069
72430831|NCT04365413|144372831|OTHER||Median Difference (Final Values)|0.069|||<|0.0001|TWO_SIDED||||||Paired t-test|||||||<0.0001
72430832|NCT04365413|144372832|OTHER||Median Difference (Final Values)|0.042|||<|0.0001|TWO_SIDED||||||Paired t-test|||||||<0.0001
72430833|NCT02037061|144372834|OTHER|||||||0.83|||||||t-test, 2 sided|||||||0.83
72430834|NCT03019458|144372837|SUPERIORITY|||||||0.084||||||The p value was not adjusted for multiple comparisons but rather it is the priori threshold for statistical significance at p\<0.05.|Mixed Models Analysis|We adjusted for baseline Eating Assessment Tool-10 (EAT-10), MGH-Swallowing Screening Test (MGH-SST), and the Burkes-Fahn-Marsden Dysonia Scale (BFM).||||||0.084
72363747|NCT04973449|144238861|NON_INFERIORITY|Noninferiority was demonstrated if the lower limit of the 2-sided 95% CI of the GMT ratio of the comparator group and reference group was \> 0.67.|GMT ratio|1.51|||||TWO_SIDED|95.0|1.35|1.69||||||The analyses were derived using ANCOVA.||1.69|1.35|
72363748|NCT04973449|144238862|NON_INFERIORITY|Noninferiority was demonstrated if the lower limit of the 2-sided 95% CI of the GMT ratio of the comparator group and reference group was \> 0.67.|GMT ratio|0.85|||||TWO_SIDED|95.0|0.78|0.94||||||The analyses were derived using ANCOVA.||0.94|0.78|
72363749|NCT04973449|144238863|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI rate difference in seroresponse between the comparator group and reference group was \> or =-10%.|Seroresponse difference|-41.2|||||TWO_SIDED|95.0|-47.57|-34.41||||||The analyses were derived using ANCOVA.||-34.41|-47.57|
72363750|NCT04973449|144238864|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI rate difference in seroresponse between the comparator group and reference group was \> or =-10%.|Seroresponse difference|6.05|||||TWO_SIDED|95.0|-1.81|13.77||||||The analyses were derived using ANCOVA.||13.77|-1.81|
72363751|NCT04973449|144238865|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI rate difference in seroresponse between the comparator group and reference group was \> or =-10%.|Seroresponse difference|-26.56|||||TWO_SIDED|95.0|-33.1|-19.94||||||The analyses were derived using ANCOVA.||-19.94|-33.10|
72363752|NCT04973449|144238866|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI rate difference in seroresponse between the comparator group and reference group was \> or =-10%.|Seroresponse difference|30.69|||||TWO_SIDED|95.0|22.94|37.9||||||The analyses were derived using ANCOVA.||37.90|22.94|
72363753|NCT04973449|144238867|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI rate difference in seroresponse between the comparator group and reference group was \> or =-10%.|Seroresponse difference|14.64|||||TWO_SIDED|95.0|6.36|22.64||||||The analyses were derived using ANCOVA.||22.64|6.36|
72363754|NCT04973449|144238868|NON_INFERIORITY|Noninferiority was demonstrated if the lower limit of the 2-sided 95% confidence interval (CI) of the GMT ratio of the comparator group and reference group was \> 0.67.|GMT ratio|0.84|||||TWO_SIDED|95.0|0.74|0.96||||||The analyses were derived using analysis of covariance (ANCOVA).||0.96|0.74|
72363755|NCT04973449|144238869|NON_INFERIORITY|Noninferiority was demonstrated if the lower limit of the 2-sided 95% CI of the GMT ratio of the comparator group and reference group was \> 0.67.|GMT ratio|1.71|||||TWO_SIDED|95.0|1.62|1.8||||||The analyses were derived using ANCOVA.||1.80|1.62|
72363756|NCT04973449|144238870|NON_INFERIORITY|Noninferiority was demonstrated if the lower limit of the 2-sided 95% CI of the GMT ratio of the comparator group and reference group was \> 0.67.|GMT ratio|0.5|||||TWO_SIDED|95.0|0.44|0.56||||||The analyses were derived using ANCOVA.||0.56|0.44|
72363757|NCT04973449|144238871|NON_INFERIORITY|Noninferiority was demonstrated if the lower limit of the 2-sided 95% CI of the GMT ratio of the comparator group and reference group was \> 0.67.|GMT ratio|0.38|||||TWO_SIDED|95.0|0.32|0.44||||||The analyses were derived using ANCOVA.||0.44|0.32|
72430835|NCT00519779|144372885|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.0033|STANDARD_ERROR_OF_MEAN|0.09||0.97|TWO_SIDED|95.0|-0.18|0.18|||Mixed Models Analysis|adjusted for baseline value, visit, gender, SAD||||0.18|-0.18|0.97
72363758|NCT05452486|144239030|EQUIVALENCE|The purpose of this study was to evaluate whether the mean performance on auditory processing assessments differed depending on whether the tests were administered in Spanish or English.|Slope|-3.89|||<|0.01|TWO_SIDED||||||Mixed Models Analysis|||Dichotic digits comparison||||<0.01
72363759|NCT05452486|144239030|EQUIVALENCE|The purpose of this study was to evaluate whether the mean performance on auditory processing assessments differed depending on whether the tests were administered in Spanish or English.|Slope|5.18||||0.69|TWO_SIDED||||||Mixed Models Analysis|||Dichotic words comparison||||0.69
72363760|NCT04408989|144239031|EQUIVALENCE|"PK similarity was achieved if the 90% CIs for the biosimilar-to-reference ratios of AUC(0-∞) were within the predefined 0.80-1.25 acceptance similarity criteria.~The PK parameter AUC(0-∞) was log-transformed (base e) prior to analysis and was analysed using an ANCOVA model. The model included treatment as a fixed effect and body weight as a covariate."|Ratio of GLSM|0.943|||||TWO_SIDED|90.0|0.899|0.989|||||For the comparison, MB02 SP represents the numerator and MB02 DM represents the denominator.|||0.989|0.899|
72363761|NCT04408989|144239031|EQUIVALENCE|"PK similarity was achieved if the 90% CIs for the biosimilar-to-reference ratios of AUC(0-∞) were within the predefined 0.80-1.25 acceptance similarity criteria.~The PK parameter AUC(0-∞) was log-transformed (base e) prior to analysis and was analysed using an ANCOVA model. The model included treatment as a fixed effect and body weight as a covariate."|Ratio of GLSM|1.0|||||TWO_SIDED|90.0|0.956|1.05|||||For the comparison, MB02 SP represents the numerator and US Avastin represents the denominator.|||1.05|0.956|
72363762|NCT04408989|144239031|EQUIVALENCE|"PK similarity was achieved if the 90% CIs for the biosimilar-to-reference ratios of AUC(0-∞) were within the predefined 0.80-1.25 acceptance similarity criteria.~The PK parameter AUC(0-∞) was log-transformed (base e) prior to analysis and was analysed using an ANCOVA model. The model included treatment as a fixed effect and body weight as a covariate."|Ratio of GLSM|1.07|||||TWO_SIDED|90.0|1.01|1.12|||||For the comparison, MB02 DM represents the numerator and US Avastin represents the denominator.|||1.12|1.01|
72363763|NCT04408989|144239032|EQUIVALENCE|"PK similarity was achieved if the 90% CIs for the biosimilar-to-reference ratios of Cmax were within the predefined 0.80-1.25 acceptance similarity criteria.~The PK parameter Cmax was log-transformed (base e) prior to analysis and was analysed using an ANCOVA model. The model included treatment as a fixed effect and body weight as a covariate."|Ratio of GLSM|0.937|||||TWO_SIDED|90.0|0.887|0.989|||||For the comparison, MB02 SP represents the numerator and MB02 DM represents the denominator.|||0.989|0.887|
72430836|NCT00519779|144372886|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.23|STANDARD_ERROR_OF_MEAN|0.11||0.04|TWO_SIDED|95.0|-0.44|-0.011|||Mixed Models Analysis|||||-0.011|-0.44|0.04
72430837|NCT00519779|144372887|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.076|STANDARD_ERROR_OF_MEAN|0.039||0.06|TWO_SIDED|95.0|-0.15|0.002|||Mixed Models Analysis|||||0.002|-0.15|0.06
72430838|NCT00519779|144372888|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.15|STANDARD_ERROR_OF_MEAN|0.072||0.04|TWO_SIDED|95.0|-0.3|-0.009|||Mixed Models Analysis|||||-0.009|-0.30|0.04
72430839|NCT00519779|144372889|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.15|STANDARD_ERROR_OF_MEAN|0.086||0.08|TWO_SIDED|95.0|-0.33|0.018|||Mixed Models Analysis|||||0.018|-0.33|0.08
72430840|NCT00519779|144372890|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.012|STANDARD_ERROR_OF_MEAN|0.14||0.93|TWO_SIDED|95.0|-0.26|0.29|||Mixed Models Analysis|||||0.29|-0.26|0.93
72430841|NCT01561079|144372891|SUPERIORITY_OR_OTHER|||||||0.001||||||The p values were not adjusted for multiplicity The a priori threshold = .05|Hierarchical Linear Modeling|The p-value was calculated||||||0.001
72430842|NCT01561079|144372892|SUPERIORITY_OR_OTHER||||||<|0.002|||||||Hierarchical Linear Modeling|||||||<.002
72430843|NCT01561079|144372893|SUPERIORITY_OR_OTHER|||||||0.0001|||||||Hierarchical Linear Modeling|||||||0.0001
72430844|NCT01561079|144372894|SUPERIORITY_OR_OTHER|||||||0.008|||||||Hierarchical Linear Modeling|The reported p-value was calculated||||||.008
72430845|NCT01561079|144372895|SUPERIORITY_OR_OTHER|||||||0.002|||||||Hierarchical Linear Modeling|||||||.002
72430846|NCT00367237|144372925|SUPERIORITY_OR_OTHER||Difference in percentages of respondents|19.61||||0.021||95.0|3.27|35.95||Comparison of treatments (IFX + MTX versus MTX)|Chi-squared||Difference in percentages of respondents is (percentage of respondents in IFX+MTX group minus percentage of respondents in MTX group)|||35.95|3.27|0.0210
72430847|NCT00367237|144372925|SUPERIORITY_OR_OTHER||Proportion of Responders|0.863||||||95.0||||||||||||
72430848|NCT00367237|144372925|SUPERIORITY_OR_OTHER||Proportion of Responders|0.667||||||95.0||||||||||||
72430849|NCT01207934|144372939|SUPERIORITY_OR_OTHER||||||>|0.05||95.0||||ANOVA for reapeated measures was used to compare the three groups.|ANOVA|||The null hypothesis was that there would be no change in glucose disposal between the three groups (placebo, low dose leptin, and high dose leptin). Power calculations were done showing that 6 subjects in each arm was enough to detect a 35% between group difference in glucose disposal at the 0.05 level with 80% power.||||>0.05
72430850|NCT01207934|144372940|SUPERIORITY_OR_OTHER||||||<|0.01||95.0||||a priori threshold for significance was set at p = 0.05.|t-test, 2 sided|T-tests compared pre and post-treatment values.||The null hypothesis is that treatment would not effect plasma leptin levels.||||<0.01
72430851|NCT01207934|144372940|SUPERIORITY_OR_OTHER||||||<|0.01||95.0||||a priori threshold for significance was p = 0.05.|t-test, 2 sided|||null hypothesis was that plasma leptin levels would be equal after treatment in the placebo and high-dose leptin groups.||||<0.01
72430852|NCT05677867|144372968|OTHER||Ratio of Adjusted Geometric Means|97.4|||||TWO_SIDED|90.0|92.92|102.08|||||The ratios (and 90% CIs) are expressed as percentages.|Natural log transformed AUCinf was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within the sequence as a random effect. The adjusted mean differences and 90% Confidence Intervals (CIs) for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CI for the ratios. Formulation A was the Reference treatment while Formulation B was the Test treatment.||102.08|92.92|
72430853|NCT05677867|144372969|OTHER||Ratio of Geometric Adjusted Means|97.36|||||TWO_SIDED|90.0|92.77|102.17|||||The ratios (and 90% CIs) are expressed as percentages.|Natural log transformed AUClast was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within the sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CI for the ratios. Formulation A was the Reference treatment while Formulation B was the Test treatment.||102.17|92.77|
72430854|NCT05677867|144372970|OTHER||Ratio of Adjusted Means|94.7|||||TWO_SIDED|90.0|81.4|110.18|||||The ratios (and 90% CIs) are expressed as percentages.|Natural log transformed Cmax was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within the sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CI for the ratios. Formulation A was the Reference treatment while Formulation B was the Test treatment.||110.18|81.40|
72430855|NCT04004208|144372975|NON_INFERIORITY|Non inferiority margin is 5%. Confidence interval actually refers to a credible interval based on the Bayesian analysis.|Difference in proportions|0.034|||||TWO_SIDED|90.0|-0.08|0.162||||||Bayesian analysis with non-informative prior distributions. Calculation of two-sided 90% credible interval for the treatment difference (aflibercept - laser photocoagulation).||0.162|-0.08|
72430856|NCT04004208|144372976|OTHER|Confidence interval actually refers to a credible interval based on the Bayesian analysis.|Difference in proportions|-0.023|||||TWO_SIDED|90.0|-0.11|0.046||||||Bayesian analysis with non-informative prior distributions. Calculation of two-sided 90% credible interval for the treatment difference (aflibercept - laser photocoagulation).||0.046|-0.11|
72430857|NCT04004208|144372977|OTHER|Confidence interval actually refers to a credible interval based on the Bayesian analysis.|Difference in proportions|0.096|||||TWO_SIDED|90.0|0.019|0.175||||||Bayesian analysis with non-informative prior distributions. Calculation of two-sided 90% credible interval for the treatment difference (aflibercept - laser photocoagulation).||0.175|0.019|
72430858|NCT00839982|144372990|SUPERIORITY|||||||0.03||||||Hypothesis: achieving CR provides an overall longer survival.|Chi-squared|||||||0.03
72430859|NCT01341080|144372995|OTHER||Cohen's d|0.15||||0.05|TWO_SIDED|95.0|-4.01|4.61|||Repeated measures analysis or variance|||Efficacy was measured as a change on the Berg Balance Scale (BBS) from baseline to the end of study after 8 weeks on drug. The BBS has a scale range of 0-56, with 56 indicating normal balance. To evaluate efficacy, repeated measures analysis of variance was run on BBS scores. The scale score was the dependent measure, time point (baseline or end of study) was the repeat measure, and treatment group (varenicline or sugar pill) was the independent measure. Significance was defined as alpha \<0.05.||4.61|-4.01|0.05
72430860|NCT01341080|144372996|OTHER||Cohen's d|0.16||||0.05|TWO_SIDED|95.0|-1.39|1.53|||Repeated measures analysis or variance|||Change in cognitive functioning was measured in part with the Frontal Assessment Battery (FAB) from Baseline to 8 weeks on drug. Repeated analysis of variance was run on the FAB scores. Scale cores was the dependent measure, time point (Baseline or end of study) was the repeated measure, and treatment group (varenicline or sugar pill) was the independent measure. Significant was defined as \<0.05.||1.53|-1.39|0.05
72430861|NCT01341080|144372997|OTHER||Cohen's d|0.81||||0.05|TWO_SIDED|95.0|-0.4|1.4|||Repeated measures analysis or variance|||Change in cognitive functioning was measured in part with the Mini Mental State Exam (MMSE) from Baseline to 8 weeks on drug. Repeated analysis of variance was run on the MMSE scores. Scale score was the dependent measure, time point (Baseline or end of study) was the repeated measure, and treatment group (varenicline or sugar pill) was the independent measure. Significant was defined as \<0.05.||1.40|-0.40|0.05
72430862|NCT02400307|144373034|EQUIVALENCE|For the power and sample size analysis, it was assumed that a one-sided t-test was performed at an alpha level of 0.05 and the inter-subject standard deviations for the three natural log scale PK parameters are 0.466 or smaller (based on another Gilead study) and the expected difference was 0.|Geometric Least-Square Mean (GLSM) Ratio|72.63|||||TWO_SIDED|90.0|48.8|108.1||||||A sample size of 8 evaluable participants in each group will provide at least 88% power to reject the null hypothesis that participants with severe impairment have at least 100% increase in bictegravir AUCinf, AUClast, or Cmax compared to participants with normal renal function.||108.10|48.80|
72430863|NCT02400307|144373035|EQUIVALENCE|For the power and sample size analysis, it was assumed that a one-sided t-test was performed at an alpha level of 0.05 and the inter-subject standard deviations for the three natural log scale PK parameters are 0.466 or smaller (based on another Gilead study) and the expected difference was 0.|GLSM Ratio|99.29|||||TWO_SIDED|90.0|79.49|124.04||||||A sample size of 8 evaluable participants in each group will provide at least 88% power to reject the null hypothesis that participants with severe impairment have at least 100% increase in bictegravir AUCinf, AUClast, or Cmax compared to participants with normal renal function.||124.04|79.49|
72430864|NCT02400307|144373036|EQUIVALENCE|For the power and sample size analysis, it was assumed that a one-sided t-test was performed at an alpha level of 0.05 and the inter-subject standard deviations for the three natural log scale PK parameters are 0.466 or smaller (based on another Gilead study) and the expected difference was 0.|GLSM Ratio|72.43|||||TWO_SIDED|90.0|48.54|108.07||||||A sample size of 8 evaluable participants in each group will provide at least 88% power to reject the null hypothesis that participants with severe impairment have at least 100% increase in bictegravir AUCinf, AUClast, or Cmax compared to participants with normal renal function.||108.07|48.54|
72430865|NCT02400307|144373037|EQUIVALENCE|For the power and sample size analysis, it was assumed that a one-sided t-test was performed at an alpha level of 0.05 and the inter-subject standard deviations for the three natural log scale PK parameters are 0.466 or smaller (based on another Gilead study) and the expected difference was 0.|GLSM Ratio|99.02|||||TWO_SIDED|90.0|79.24|123.74||||||A sample size of 8 evaluable participants in each group will provide at least 88% power to reject the null hypothesis that participants with severe impairment have at least 100% increase in bictegravir AUCinf, AUClast, or Cmax compared to participants with normal renal function.||123.74|79.24|
72430866|NCT02400307|144373038|EQUIVALENCE|For the power and sample size analysis, it was assumed that a one-sided t-test was performed at an alpha level of 0.05 and the inter-subject standard deviations for the three natural log scale PK parameters are 0.466 or smaller (based on another Gilead study) and the expected difference was 0.|GLSM Ratio|80.32|||||TWO_SIDED|90.0|59.56|108.3||||||A sample size of 8 evaluable participants in each group will provide at least 88% power to reject the null hypothesis that participants with severe impairment have at least 100% increase in bictegravir AUCinf, AUClast, or Cmax compared to participants with normal renal function.||108.30|59.56|
72430867|NCT02400307|144373039|EQUIVALENCE|For the power and sample size analysis, it was assumed that a one-sided t-test was performed at an alpha level of 0.05 and the inter-subject standard deviations for the three natural log scale PK parameters are 0.466 or smaller (based on another Gilead study) and the expected difference was 0.|GLSM Ratio|109.8|||||TWO_SIDED|90.0|87.46|137.85||||||A sample size of 8 evaluable participants in each group will provide at least 88% power to reject the null hypothesis that participants with severe impairment have at least 100% increase in bictegravir AUCinf, AUClast, or Cmax compared to participants with normal renal function.||137.85|87.46|
72430868|NCT03248440|144373042|SUPERIORITY|||||||0.579|||||||2-sided Pearson's chi-square|||||||0.579
72430869|NCT03248440|144373043|SUPERIORITY|||||||0.082|||||||2-sided Pearson's chi-square|||||||0.082
72430870|NCT01052662|144373044|SUPERIORITY_OR_OTHER||Slope|-0.00935|STANDARD_ERROR_OF_MEAN|0.00356|=|0.00874|TWO_SIDED||||||Mixed Models Analysis||Z = -2.62209|We modeled the mean proportion of weekly opioid use using a mixed-effect linear regression approach to assess the treatment effect, the time effect and the interaction of time x treatment effect while adjusting for the baseline mean proportion of weekly opioid use with baseline COWS, Addiction Severity Index (ASI) psychiatric and legal composite scores as covariates.||||=0.00874
72430871|NCT01052662|144373045|SUPERIORITY_OR_OTHER||Hazard Ratio, log|0.87||||0.64|TWO_SIDED||||||Log Rank|||||||0.64
72430872|NCT01052662|144373046|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|2.4||||1.2|TWO_SIDED|||||These results are using survival curve estimates to first positive urine toxicology for any opioid. The last observation carried forward (LOCF) was used to perform our survival event analyses.|Log Rank|||||||1.2
72430873|NCT01852955|144373089|SUPERIORITY_OR_OTHER|||||||0.01|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.01
72430874|NCT01852955|144373090|SUPERIORITY_OR_OTHER|||||||0.04|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.04
72430875|NCT01852955|144373091|SUPERIORITY_OR_OTHER|||||||0.36|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.36
72430876|NCT00410384|144373141|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.54||||0.0167|TWO_SIDED|95.0|1.08|2.19||For the primary analysis of the primary efficacy endpoint, a step-down sequential testing procedure was used to control the type 1 error.|Regression, Logistic|Adjusted for baseline stratification factors (SELENA SLEDAI Score: ≤9 vs ≥10; proteinuria: \<2g vs ≥2g per 24hr; Race: African/indig-American vs Other)||||2.19|1.08|0.0167
72430877|NCT00410384|144373141|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.36||||0.0889|TWO_SIDED|95.0|0.95|1.94||After superiority of 10 mg/kg vs placebo was established, the 1 mg/kg group was tested vs placebo (2-sided alpha=0.05)|Regression, Logistic|Adjusted for baseline stratification factors.||||1.94|0.95|0.0889
72430878|NCT00410384|144373142|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.31||||0.1323|TWO_SIDED|95.0|0.92|1.87|||Regression, Logistic|Analysis was adjusted for baseline stratification factors.||||1.87|0.92|0.1323
72430879|NCT00410384|144373142|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.34||||0.105|TWO_SIDED|95.0|0.94|1.91|||Regression, Logistic||Analysis was adjusted for baseline stratification factors.|||1.91|0.94|0.1050
72430880|NCT00410384|144373143|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.63||||0.0063|TWO_SIDED|95.0|1.15|2.32|||Regression, Logistic|Adjusted for baseline stratification factors.||||2.32|1.15|0.0063
72430881|NCT00410384|144373143|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.38||||0.074|TWO_SIDED|95.0|0.97|1.96|||Regression, Logistic|Adjusted for baseline stratification factors.||||1.96|0.97|0.0740
72430882|NCT00410384|144373144|SUPERIORITY_OR_OTHER|||||||0.7962|||||||ANCOVA|Adjusted for baseline PGA and baseline stratification factors.||||||0.7962
72430883|NCT00410384|144373144|SUPERIORITY_OR_OTHER|||||||0.9703|||||||ANCOVA|Adjusted for baseline PGA and baseline stratification factors.||||||0.9703
72430884|NCT00410384|144373145|SUPERIORITY_OR_OTHER|||||||0.6583|||||||ANCOVA|Analysis adjusted for baseline PCS and baseline stratification factors.||||||0.6583
72430885|NCT00410384|144373145|SUPERIORITY_OR_OTHER|||||||0.3762|||||||ANCOVA|Analysis adjusted for baseline PCS and baseline stratification factors.||||||0.3762
72430886|NCT00410384|144373146|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.34||||0.4253|TWO_SIDED|95.0|0.65|2.74|||Regression, Logistic|Analysis was adjusted for baseline prednisone dose and baseline stratification factors.||||2.74|0.65|0.4253
72430887|NCT00410384|144373146|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.56||||0.2081|TWO_SIDED|95.0|0.78|3.13|||Regression, Logistic|Analysis was adjusted for baseline prednisone dose and baseline stratification factors.||||3.13|0.78|0.2081
72430888|NCT01253200|144373150|NON_INFERIORITY_OR_EQUIVALENCE|The Primary Safety Endpoint was evaluated using a one-sided, non-inferiority test for two binomial proportions at an alpha-level of 0.05. A 95% confidence interval based upon a score test of the difference of proportion of subjects in the Investigational and Control Groups free from a procedure-related complication seven days post-procedure was constructed. The upper bound of the confidence interval was compared to 10%.|Risk Difference (RD)|4.6|||||ONE_SIDED|95.0||9.78||||||Note that analysis of the primary outcome was conducted for Randomized subjects only as prespecified in the study protocol. This is consistent analysis publicly available in the Summary of Safety and Effectiveness Data (SSED).||9.78||
72430889|NCT04883346|144373155|SUPERIORITY||Mean Difference (Final Values)|-3.2|STANDARD_DEVIATION|3.4|<|0.001|TWO_SIDED||||||t-test, 2 sided|Paired t-test, 32 degrees of freedom (one participant did not have baseline DEXA data so could not be included.||||||<0.001
72430890|NCT04883346|144373156|SUPERIORITY||Mean Difference (Final Values)|-1.7|STANDARD_DEVIATION|1.5|<|0.001|TWO_SIDED||||||t-test, 2 sided|Paired t-test, 33 degrees of freedom.||||||<0.001
72430891|NCT04883346|144373157|SUPERIORITY||Mean Difference (Final Values)|-0.2|STANDARD_DEVIATION|0.1|<|0.001|TWO_SIDED||||||t-test, 2 sided|Paired t-test, 33 degrees of freedom||||||<0.001
72430892|NCT04883346|144373158|SUPERIORITY|Paired t-test.|Mean Difference (Final Values)|-4.4|STANDARD_DEVIATION|4.4|<|0.001|TWO_SIDED||||||t-test, 2 sided|Paired t-test, 33 degrees of freedom||||||<0.001
72430893|NCT04529538|144373167|OTHER||GMT Ratio|0.68|||||TWO_SIDED|95.0|0.252|1.838|||||GMT ratios (nOPV/mOPV) were estimated via a linear model of the log₂ neutralizing antibody titer as a function of group with a fixed parameter for site and a covariate for the baseline log₂ neutralizing antibody titer level.|Comparison of Type 1 neutralizing antibody GMT at Day 29||1.838|0.252|
72430894|NCT04529538|144373168|OTHER||GMT Ratio|1.26|||||TWO_SIDED|95.0|0.232|6.833|||||GMT ratios (nOPV/mOPV) were estimated via a linear model of the log₂ neutralizing antibody titer as a function of group with a fixed parameter for site and a covariate for the baseline log₂ neutralizing antibody titer level.|Comparison of type 1 neutralizing antibody GMT at Day 29||6.833|0.232|
72430895|NCT04529538|144373168|OTHER||GMT Ratio|1.98|||||TWO_SIDED|95.0|0.603|6.528|||||GMT ratios (nOPV/mOPV) were estimated via a linear model of the log₂ neutralizing antibody titer as a function of group with a fixed parameter for site and a covariate for the baseline log₂ neutralizing antibody titer level.|Comparison of type 1 neutralizing antibody GMT at Day 57||6.528|0.603|
72430896|NCT04529538|144373169|OTHER||GMT Ratio|1.56|||||TWO_SIDED|95.0|0.639|3.828|||||GMT ratios (nOPV/mOPV) were estimated via a linear model of the log₂ neutralizing antibody titer as a function of group with a fixed parameter for site and a covariate for the baseline log₂ neutralizing antibody titer level.|Comparison of type 3 neutralizing antibody GMT at Day 29||3.828|0.639|
72430897|NCT04529538|144373170|OTHER||GMT Ratio|1.79|||||TWO_SIDED|95.0|0.772|4.163|||||GMT ratios (nOPV/mOPV) were estimated via a linear model of the log₂ neutralizing antibody titer as a function of group with a fixed parameter for site and a covariate for the baseline log₂ neutralizing antibody titer level.|Comparison of type 3 neutralizing antibody GMT at Day 29||4.163|0.772|
72430898|NCT04529538|144373170|OTHER||GMT Ratio|2.51|||||TWO_SIDED|95.0|0.994|6.34|||||GMT ratios (nOPV/mOPV) were estimated via a linear model of the log₂ neutralizing antibody titer as a function of group with a fixed parameter for site and a covariate for the baseline log₂ neutralizing antibody titer level.|Comparison of type 3 neutralizing antibody GMT at Day 57||6.340|0.994|
72430899|NCT04529538|144373171|OTHER||Rate Difference|-4.0|||>|0.999|TWO_SIDED|95.0|-27.67|22.72|||Fisher Exact||Rate Difference = nOPV - mOPV|Between-Group Seroconversion Rate (4-fold rise) in Neutralizing Antibody Titers||22.72|-27.67|>0.999
72430900|NCT04529538|144373172|OTHER||Rate Difference|-2.8|||>|0.999|TWO_SIDED|95.0|-20.47|20.86|||Fisher Exact||Rate Difference = nOPV - mOPV|Between-group seroconversion rate (4-fold rise) in neutralizing antibody titers 28 days after first dose.||20.86|-20.47|>0.999
72430901|NCT04529538|144373172|OTHER||Rate Difference|8.3||||0.263|TWO_SIDED|95.0|-5.71|30.57|||Fisher Exact||Rate Difference = nOPV - mOPV|Between-group comparison of seroconversion rate (4-fold rise) in neutralizing antibody titers 28 days after 2nd dose.||30.57|-5.71|0.263
72430902|NCT04529538|144373173|OTHER||Rate Difference|14.3||||0.224|TWO_SIDED|95.0|-8.3|40.45|||Fisher Exact||Rate Difference = nOPV - mOPV|Between-group seroconversion rate (4-fold rise) in neutralizing antibody titers 28 days after vaccination||40.45|-8.30|0.224
72430903|NCT04529538|144373174|OTHER||Rate Difference|9.8||||0.275|TWO_SIDED|95.0|-7.29|35.19|||Fisher Exact||Rate Difference = nOPV - mOPV|Between-group comparison of seroconversion rate (4-fold rise) in neutralizing antibody titers 28 days after first dose.||35.19|-7.29|0.275
72430904|NCT04529538|144373174|OTHER||Rate Difference|17.9||||0.1|TWO_SIDED|95.0|-1.27|44.93|||Fisher Exact||Rate Difference = nOPV - mOPV|Between-group comparison of seroconversion rate (4-fold rise) in neutralizing antibody titers 28 days after 2nd dose.||44.93|-1.27|0.100
72430905|NCT00235495|144373185|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.96|||||TWO_SIDED|95.0|0.84|1.1||The generalized linear model with log link function is tested at the one-sided alpha level of 0.025.|Regression, Logistic|Adjustment is made for baseline NIHSS and Thrombolysis stratum.|Adjusted risk ratio greater than 1 indicates greater risk of good outcome in the Albumin treatment group, while adjusted risk ratio less than 1 indicates greater risk of good outcome in the Saline treatment group.|Test of null hypothesis (equal proportions of subjects with NIHSS 0-1 or mRS 0-1 or both at 90 days post-randomization in Albumin and Saline treatment arms) versus alternative hypothesis (greater proportion of subjects with NIHSS 0-1 or mRS 0-1 or both at 90 days post-randomization in Albumin treatment arm).||1.10|0.84|
72430906|NCT00235495|144373186|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.93|||||TWO_SIDED|99.0|0.8|1.09|||Regression, Logistic|||||1.09|0.80|
72430907|NCT00235495|144373187|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.99|||||TWO_SIDED|99.0|0.66|1.49|||Regression, Logistic|||||1.49|0.66|
72430908|NCT00235495|144373188|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.88|||||TWO_SIDED|99.0|0.71|1.1|||Regression, Logistic|||||1.10|0.71|
72430909|NCT00235495|144373189|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|1.03|||||TWO_SIDED|99.0|0.82|1.28|||Regression, Logistic|||||1.28|0.82|
72430910|NCT00235495|144373190|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.99|||||TWO_SIDED|99.0|0.85|1.13|||Regression, Logistic|||||1.13|0.85|
72430911|NCT00235495|144373191|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.98|||||TWO_SIDED|99.0|0.87|1.11|||Regression, Logistic|||||1.11|0.87|
72430912|NCT00235495|144373192|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.95|||||TWO_SIDED|99.0|0.83|1.1|||Regression, Logistic|||||1.10|0.83|
72430913|NCT00235495|144373193|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.99|||||TWO_SIDED|99.0|0.84|1.17|||Regression, Logistic|||||1.17|0.84|
72430914|NCT00235495|144373194|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.93|||||TWO_SIDED|99.0|0.84|1.02|||Regression, Logistic|||||1.02|0.84|
72430915|NCT00235495|144373195|SUPERIORITY_OR_OTHER_LEGACY||Rank Sum|73098.0||||0.913||95.0|||||Wilcoxon rank sum test, normal approx|||||||0.913
72430916|NCT00235495|144373196|SUPERIORITY_OR_OTHER_LEGACY||Rank Sum|44853.5||||0.923||95.0|||||Wilcoxon rank sum test, normal approx|||||||0.923
72430917|NCT00235495|144373197|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|1.18|||||TWO_SIDED|95.0|0.79|1.76|||Regression, Logistic|||||1.76|0.79|
72430918|NCT00235495|144373198|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|1.01|||||TWO_SIDED|95.0|0.47|2.15|||Regression, Logistic|||||2.15|0.47|
72430919|NCT00235495|144373199|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|1.16|||||TWO_SIDED|95.0|0.39|3.41|||Regression, Logistic|||||3.41|0.39|
72430920|NCT00235495|144373200|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|1.69|||||TWO_SIDED|95.0|0.98|2.94|||Regression, Logistic|||||2.94|0.98|
72430921|NCT00235495|144373201|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|10.8|||||TWO_SIDED|95.0|4.37|26.72|||Regression, Logistic|||||26.72|4.37|
72430922|NCT00235495|144373202|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|2.58|||||TWO_SIDED|95.0|1.09|6.12|||Regression, Logistic|||||6.12|1.09|
72430923|NCT00235495|144373203|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|2.42|||||TWO_SIDED|95.0|1.02|5.78|||Regression, Logistic|||||5.78|1.02|
72430924|NCT00235495|144373204|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|1.14|||||TWO_SIDED|95.0|0.68|2.01|||Regression, Logistic|||||2.01|0.68|
72430925|NCT00235495|144373205|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|1.05|||||TWO_SIDED|95.0|0.68|1.61|||Regression, Logistic|||||1.61|0.68|
72430926|NCT00235495|144373206|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|1.1|||||TWO_SIDED|95.0|0.74|1.63|||Regression, Logistic|||||1.63|0.74|
72430927|NCT05567952|144373244|SUPERIORITY||Least square (LS) mean difference|-0.705|||=|0.0004|TWO_SIDED|95.0|-1.093|-0.316|||MMRM|||Mixed model for repeated measures (MMRM) included fixed effects of treatment, geographic region, baseline SARS-CoV-2 RNA level, visit, and treatment-by-visit interaction; an unstructured (co) variance structure was used.||-0.316|-1.093|= 0.0004
72430928|NCT05567952|144373245|SUPERIORITY||Hazard Ratio (HR)|1.235|||=|0.0697|TWO_SIDED|95.0|0.983|1.551|||COX proportional hazard ratio|||Analysis was based on Cox proportional hazard (PH) model which included treatment, geographic region, baseline SARS-CoV-2 RNA level (\< 4 log10 copies/mL or \>= 4 log10 copies/mL) and time since the last vaccination (less than or equal to \[\<=6\] months, \> 6 months or unvaccinated) as appropriate.||1.551|0.983|= 0.0697
72430929|NCT05567952|144373246|SUPERIORITY||Hazard Ratio (HR)|1.084|||=|0.5202|TWO_SIDED|95.0|0.848|1.385|||COX proportional hazard ratio|||Analysis was based on Cox proportional hazard (PH) model which included treatment, geographic region, baseline SARS-CoV-2 RNA level (\< 4 log10 copies/mL or \>= 4 log10 copies/mL) and time since the last vaccination (\<=6 months, \> 6 months or unvaccinated) as appropriate.||1.385|0.848|= 0.5202
72430930|NCT00777803|144373248|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% Newcombe confidence interval for proportions (paired data) was applied. The lower bound of the Newcombe-Wilson confidence interval of the difference in response rates between groups was compared to the non-inferiority margin of -15%.|difference of response rates|0.7|||||TWO_SIDED|95.0|-3.2|7.1|||||Difference of response rates = response rate in IncobotulinumtoxinA (Xeomin®/Bocouture®) - response rate in OnabotulinumtoxinA (Vistabel®)|Null Hypothesis: Response rate of IncobotulinumtoxinA (Xeomin®/Bocouture®) minus the response rate of OnabotulinumtoxinA (Vistabel®) is lower or equal -15% (non-inferiority margin).||7.1|-3.2|
72430931|NCT05160025|144373286|SUPERIORITY||||||<|0.001||||||"rmANOVA \< 0.001~post hoc paired t-tests or nonparametric equivalent with correction (x3) indicated the following: self-competition \> feedback (p \< 0.001) other-competition \> feedback (p \< 0.001) self-competition = other-competition (p \> 0.05)"|ANOVA|||||||<0.001
72430932|NCT05160025|144373289|SUPERIORITY|||||||0.111||||||"rmANOVA p = 0.111~post hoc paired t-tests not performed"|ANOVA|||||||0.111
72430933|NCT05160025|144373292|SUPERIORITY||||||<|0.001||||||"rmANOVA \< 0.001~post hoc paired t-tests or nonparametric equivalent corrected (x3) indicated the following: self-competition \> feedback (p = 0.003) other-competition \> feedback (p = 0.007) self-competition = other-competition (p \> 0.05)"|ANOVA|||||||<0.001
72430934|NCT05160025|144373295|SUPERIORITY||||||>|0.05||||||"rmANOVA p \> 0.05 with a partial eta squared effect size = 0.073~post hoc paired t-tests not performed"|ANOVA|||||||> 0.05
72430935|NCT05160025|144373300|SUPERIORITY|||||||0.004||||||"rmANOVA = 0.004~post hoc paired t-tests or nonparametric equivalent corrected (x3) indicated the following: self-competition \> feedback (p = 0.007) other-competition \> feedback (p = 0.002) self-competition = other-competition (p \> 0.05)"|ANOVA|||||||0.004
72430936|NCT05160025|144373308|SUPERIORITY||||||>|0.05||||||ranking compared to expected value for each condition and the p-value was adjusted for 3 comparisons for each condition: self-competition (p \> 0.05) other-competition (p \> 0.05) feedback (p \> 0.05)|Chi-squared|||||||> 0.05
72430937|NCT05160025|144373309|SUPERIORITY||||||>|0.05||||||ranking compared to expected value for each condition and the p-value was adjusted for 3 comparisons for each condition: self-competition (p \> 0.05) other-competition (p \> 0.05) feedback (p \> 0.05)|Chi-squared|||||||> 0.05
72430938|NCT05516342|144373314|SUPERIORITY||||||<|0.01|||||||ANOVA|||||||<0.01
72430939|NCT05516342|144373315|SUPERIORITY||||||<|0.01|||||||ANOVA|||||||<0.01
72430940|NCT05516342|144373316|SUPERIORITY||||||<|0.01|||||||ANOVA|||||||<0.01
72430941|NCT05516342|144373317|SUPERIORITY||||||<|0.01|||||||ANOVA|||||||<0.01
72430942|NCT05516342|144373318|SUPERIORITY||||||<|0.01|||||||ANOVA|||||||<0.01
72430943|NCT05516342|144373319|SUPERIORITY|||||||0.89|||||||ANOVA|||||||0.89
72430944|NCT05516342|144373320|SUPERIORITY|||||||0.27|||||||ANOVA|||||||0.27
72430945|NCT05516342|144373321|SUPERIORITY|||||||0.19|||||||ANOVA|||||||0.19
72430946|NCT05516342|144373322|SUPERIORITY|||||||0.1|||||||ANOVA|||||||0.10
72430947|NCT01852162|144373323|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|||||An analysis of covariance (ANCOVA) method with a general linear model, using the corresponding baseline PD value as a covariate, was used to evaluate the comparisons between dabigatran and placebo at 7 days.|ANCOVA|||Assuming a 20% relative difference in TRAP induced MPA between dabigatran and placebo with a common standard deviation of 10%, 13 patients with available data needed to be randomized to obtain a 95% power and 2-sided alpha=0.05.||||<0.05
72430948|NCT01866475|144373328|NON_INFERIORITY|This study is designed to test the hypothesis that the IO device has no greater than a 4 percent infection rate. Equivalently, we define success as having at least a 96 percent infection free 48-hour placement.|||||||||||||||||The historical data for the device suggests an infection rate of 0.6 percent per 48 hours or a success rate of 99.4 percent. The formal objective in the design is to reject the one-sided null hypothesis that the success rate is no higher than 96 percent. The analysis will use the exact binomial test and will tolerate a Type I Error rate of 0.05 or less. If we assume a 99.4 percent success rate, the study will have 84 percent power with a sample size of 117 to reject the null hypothesis. If the null hypothesis is rejected, we conclude that the infection rate is less than 4 percent.|||
72430949|NCT03251144|144373337|OTHER||Mean Difference (Final Values)|20.0|STANDARD_ERROR_OF_MEAN|3.0|<|0.001|TWO_SIDED||||||t-test, 2 sided|||||||<0.001
72430950|NCT05305040|144373339|SUPERIORITY||Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.049||0.5603|TWO_SIDED|95.0|-0.09|0.1||1-sided p-value|ANCOVA|||||0.10|-0.09|0.5603
72430951|NCT01276535|144373389|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED|95.0|||||t-test, 2 sided|||Comparison is made of the combined application of the Erchonia MLS and the Erchonia THL. Results are analyzed at 6 weeks relative to Baseline.||||<0.01
72430952|NCT01276535|144373390|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED|95.0|||||t-test, 2 sided|||Comparison is made of the combined application of the Erchonia MLS and the Erchonia THL. Results are analyzed at 6 weeks relative to Baseline.||||<0.01
72430953|NCT01818700|144373400|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.65|STANDARD_DEVIATION|1.96|<|0.05|TWO_SIDED|95.0|-10.0|10.0|||t-test, 2 sided|"The primary endpoint will be the actual reduction rate of pain intensity (0 -10) score at 8 weeks.~It will be analyzed by using paired t-test."||||10|-10|<0.05
72430954|NCT00087490|144373414|NON_INFERIORITY_OR_EQUIVALENCE|Linezolid was claimed non-inferior to vancomycin if the lower limit of 95% CI for the difference in cure rate is greater than the Food and Drug Administration (FDA) suggested boundary of delta= -0.10.|Percent Difference|4.2||||0.249|TWO_SIDED|95.0|-3.0|11.5|||Chi-squared|||The percent difference was calculated by percentage of participants cured in linezolid arm minus the percentage of participants cured in vancomycin arm along with 2-sided 95 percent (%) confidence interval (CI).||11.5|-3.0|0.249
72430955|NCT00087490|144373415|NON_INFERIORITY_OR_EQUIVALENCE|Linezolid was claimed non-inferior to vancomycin if the lower limit of 95% CI for the difference in cure rate is greater than the FDA suggested boundary of delta= -0.10.|Percent Difference|3.9||||0.168|TWO_SIDED|95.0|-1.7|9.5|||Chi-squared|||The percent difference was calculated by percentage of participants cured in linezolid arm minus the percentage of participants cured in vancomycin arm along with 2-sided 95% CI.||9.5|-1.7|0.168
72430956|NCT00087490|144373416|NON_INFERIORITY_OR_EQUIVALENCE|Linezolid was claimed non-inferior to vancomycin if the lower limit of 95% CI for the difference in cure rate is greater than the FDA suggested boundary of delta= -0.10.|Percent Difference|7.1||||0.048|TWO_SIDED|95.0|0.1|14.2|||Chi-squared|||The percent difference was calculated by percentage of participants cured in linezolid arm minus the percentage of participants cured in vancomycin arm along with 2-sided 95% CI.||14.2|0.1|0.048
72430957|NCT00087490|144373417|NON_INFERIORITY_OR_EQUIVALENCE|Linezolid was claimed non-inferior to vancomycin if the lower limit of 95% CI for the difference in cure rate is greater than the FDA suggested boundary of delta= -0.10.|Percent Difference|4.8||||0.09|TWO_SIDED|95.0|-0.7|10.3|||Chi-squared|||The percent difference was calculated by percentage of participants cured in linezolid arm minus the percentage of participants cured in vancomycin arm along with 2-sided 95% CI.||10.3|-0.7|0.090
72430958|NCT00087490|144373418|NON_INFERIORITY_OR_EQUIVALENCE|Linezolid was claimed non-inferior to vancomycin if the lower limit of 95% CI for the difference in cure rate is greater than the FDA suggested boundary of delta= -0.10.|Percent Difference|6.6||||0.127|TWO_SIDED|95.0|-1.9|15.0|||Chi-squared|||The percent difference was calculated by percentage of participants cured in linezolid arm minus the percentage of participants cured in vancomycin arm along with 2-sided 95% CI.||15.0|-1.9|0.127
72430959|NCT00087490|144373419|NON_INFERIORITY_OR_EQUIVALENCE|Linezolid was claimed non-inferior to vancomycin if the lower limit of 95% CI for the difference in cure rate is greater than the FDA suggested boundary of delta= -0.10.|Percent Difference|16.6||||0|TWO_SIDED|95.0|9.0|24.2|||Chi-squared|||The percent difference was calculated by percentage of participants cured in linezolid arm minus the percentage of participants cured in vancomycin arm along with 2-sided 95% CI.||24.2|9.0|0.000
72430960|NCT00087490|144373420|NON_INFERIORITY_OR_EQUIVALENCE|Linezolid was claimed non-inferior to vancomycin if the lower limit of 95% CI for the difference in cure rate is greater than the FDA suggested boundary of delta= -0.10.|Percent Difference|7.7||||0.051|TWO_SIDED|95.0|0.0|15.4|||Chi-squared|||The percent difference was calculated by percentage of participants cured in linezolid arm minus the percentage of participants cured in vancomycin arm along with 2-sided 95% CI.||15.4|-0.0|0.051
72430961|NCT00087490|144373421|NON_INFERIORITY_OR_EQUIVALENCE|Linezolid was claimed non-inferior to vancomycin if the lower limit of 95% CI for the difference in cure rate is greater than the FDA suggested boundary of delta= -0.10.|Percent Difference|15.0||||0|TWO_SIDED|95.0|8.2|21.8|||Chi-squared|||The percent difference was calculated by percentage of participants cured in linezolid arm minus the percentage of participants cured in vancomycin arm along with 2-sided 95% CI.||21.8|8.2|0.000
72430962|NCT00087490|144373424|SUPERIORITY_OR_OTHER|||||||0.022|TWO_SIDED|||||Alpha = 0.05 was the level of significance if the null hypothesis was rejected.|Wilcoxon (Mann-Whitney)|||Null hypothesis was that there was no difference in the length of hospital stay between the treatment groups.||||0.022
72430963|NCT00087490|144373425|SUPERIORITY_OR_OTHER|||||||0.016|TWO_SIDED|||||Alpha = 0.05 was the level of significance if the null hypothesis was rejected.|Wilcoxon (Mann-Whitney)|||Null hypothesis was that there was no difference in the length of hospital stay between the treatment groups.||||0.016
72430964|NCT00087490|144373426|SUPERIORITY_OR_OTHER|||||||0|TWO_SIDED||||||t-test, 2 sided|||||||0.000
72430965|NCT00087490|144373427|SUPERIORITY_OR_OTHER|||||||0|TWO_SIDED||||||t-test, 2 sided|||||||0.000
72430966|NCT01253980|144373442|SUPERIORITY_OR_OTHER||Relative risk|0.6|||>|0.5|TWO_SIDED|95.0|0.11|3.37|||Fisher Exact|||||3.37|0.11|>0.50
72430967|NCT01700530|144373443|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||ANOVA|||||||<0.05
72430968|NCT04833855|144373453|SUPERIORITY||LSM difference|0.0|STANDARD_ERROR_OF_MEAN|2.2||0.99|TWO_SIDED|95.0|-4.3|4.4||Nominal p-value|Repeated measure model|Model parameters: stratification factor (prior anti-IgE status), baseline UAS7, treatment, study week, interaction between treatment and study week.|Tezepelumab 210 mg SC Q4W - Placebo|||4.4|-4.3|0.99
72430969|NCT04833855|144373453|SUPERIORITY||LSM difference|-1.1|STANDARD_ERROR_OF_MEAN|2.2||0.6|TWO_SIDED|95.0|-5.4|3.1||Nominal p-value|Repeated measure model|Model parameters: stratification factor (prior anti-IgE status), baseline UAS7, treatment, study week, interaction between treatment and study week.|Tezepelumab 420 mg SC Q2W - Placebo|||3.1|-5.4|0.60
72430970|NCT03682536|144373495|SUPERIORITY||Odds Ratio (OR)|3.1|||<|0.0001|TWO_SIDED|95.0|2.0|4.8|||Cochran-Mantel-Haenszel|||||4.8|2.0|<.0001
72430971|NCT03682536|144373496|SUPERIORITY||Odds Ratio (OR)|2.3||||0.0003|TWO_SIDED|95.0|1.4|3.7|||Cochran-Mantel-Haenszel|||||3.7|1.4|0.0003
72430972|NCT03682536|144373498|SUPERIORITY||Odds Ratio (OR)|2.8|||<|0.0001|TWO_SIDED|95.0|1.8|4.5|||Cochran-Mantel-Haenszel|||||4.5|1.8|<.0001
72430973|NCT03682536|144373500|SUPERIORITY||Odds Ratio (OR)|2.5|||<|0.0001|TWO_SIDED|95.0|1.6|4.0|||Cochran-Mantel-Haenszel|||||4.0|1.6|<.0001
72430974|NCT03682536|144373501|SUPERIORITY||Hazard Ratio (HR)|0.534||||0.0096|TWO_SIDED|95.0|0.33|0.864|||Log Rank||Calculated by Cox proportional hazard model|||0.864|0.330|0.0096
72430975|NCT03682536|144373505|SUPERIORITY||Odds Ratio (OR)|2.3||||0.0007|TWO_SIDED|95.0|1.4|3.8|||Cochran-Mantel-Haenszel|||||3.8|1.4|0.0007
72430976|NCT03682536|144373506|SUPERIORITY||Odds Ratio (OR)|2.6|||<|0.0001|TWO_SIDED|95.0|1.6|4.3|||Cochran-Mantel-Haenszel|||||4.3|1.6|<.0001
72430977|NCT03714022|144373634|EQUIVALENCE|Equivalence is concluded if the 90% CIs for the ratios of geometric means are contained within 0.8 to 1.25|Ratio of Geometric Means|0.998|||||TWO_SIDED|90.0|0.941|1.058|||||Cohort A vs Cohort B|||1.058|0.941|
72430978|NCT03714022|144373635|EQUIVALENCE|Equivalence is concluded if the 90% CIs for the ratios of geometric means are contained within 0.8 to 1.25|Ratio of Geometric Means|0.929|||||TWO_SIDED|90.0|0.884|0.976|||||Cohort A vs Cohort B|||0.976|0.884|
72430979|NCT03714022|144373637|EQUIVALENCE|Equivalence is concluded if the 90% CIs for the ratios of geometric means are contained within 0.8 to 1.25|Ratio of Geometric Means|0.936|||||TWO_SIDED|90.0|0.891|0.983|||||Cohort A vs Cohort B|||0.983|0.891|
72430980|NCT03714022|144373638|EQUIVALENCE|Equivalence is concluded if the 90% CIs for the ratios of geometric means are contained within 0.8 to 1.25|Ratio of Geometric Means|0.957|||||TWO_SIDED|90.0|0.915|1.001|||||Cohort A vs Cohort B|||1.001|0.915|
72430981|NCT04447820|144373685|NON_INFERIORITY|Approximately 90 participants were planned. Assuming an effect size delta = 0, pooled SD = 21.38, an alpha = 0.05 (1-sided), and a non-inferiority limit of 15%, a sample size of 26 patients per treatment group provided a power of 0.80. In the case that the actual effect size delta was 10%, the power was then 0.2. If the real effect was different, the result less likely showed non-inferiority. To account for any potential drop off, 30 participants in each treatment group, were planned.||||||0.3084|||||||Mixed Model for repeated measures (MMRM)|||||||0.3084
72430982|NCT04447820|144373685|NON_INFERIORITY|Approximately 90 participants were planned. Assuming an effect size delta = 0, pooled SD = 21.38, an alpha = 0.05 (1-sided), and a non-inferiority limit of 15%, a sample size of 26 patients per treatment group provided a power of 0.80. In the case that the actual effect size delta was 10%, the power was then 0.2. If the real effect was different, the result less likely showed non-inferiority. To account for any potential drop off, 30 participants in each treatment group, were planned.||||||0.593|||||||Mixed Model for repeated measures (MMRM)|||||||0.5930
72430983|NCT04447820|144373686|NON_INFERIORITY|Approximately 90 participants were planned. Assuming an effect size delta = 0, pooled SD = 21.38, an alpha = 0.05 (1-sided), and a non-inferiority limit of 15%, a sample size of 26 patients per treatment group provided a power of 0.80. In the case that the actual effect size delta was 10%, the power was then 0.2. If the real effect was different, the result less likely showed non-inferiority. To account for any potential drop off, 30 participants in each treatment group, were planned.||||||0.9788|||||||MMRM|||||||0.9788
72430984|NCT04447820|144373686|NON_INFERIORITY|Approximately 90 participants were planned. Assuming an effect size delta = 0, pooled SD = 21.38, an alpha = 0.05 (1-sided), and a non-inferiority limit of 15%, a sample size of 26 patients per treatment group provided a power of 0.80. In the case that the actual effect size delta was 10%, the power was then 0.2. If the real effect was different, the result less likely showed non-inferiority. To account for any potential drop off, 30 participants in each treatment group, were planned.||||||0.1314|||||||MMRM|||||||0.1314
72430985|NCT04447820|144373687|NON_INFERIORITY|Approximately 90 participants were planned. Assuming an effect size delta = 0, pooled SD = 21.38, an alpha = 0.05 (1-sided), and a non-inferiority limit of 15%, a sample size of 26 patients per treatment group provided a power of 0.80. In the case that the actual effect size delta was 10%, the power was then 0.2. If the real effect was different, the result less likely showed non-inferiority. To account for any potential drop off, 30 participants in each treatment group, were planned.||||||0.884|||||||MMRM analysis|||||||0.8840
72430986|NCT04447820|144373687|NON_INFERIORITY|Approximately 90 participants were planned. Assuming an effect size delta = 0, pooled SD = 21.38, an alpha = 0.05 (1-sided), and a non-inferiority limit of 15%, a sample size of 26 patients per treatment group provided a power of 0.80. In the case that the actual effect size delta was 10%, the power was then 0.2. If the real effect was different, the result less likely showed non-inferiority. To account for any potential drop off, 30 participants in each treatment group, were planned.||||||0.1202|||||||MMRM analysis|||||||0.1202
72430987|NCT04447820|144373688|NON_INFERIORITY|Approximately 90 participants were planned. Assuming an effect size delta = 0, pooled SD = 21.38, an alpha = 0.05 (1-sided), and a non-inferiority limit of 15%, a sample size of 26 patients per treatment group provided a power of 0.80. In the case that the actual effect size delta was 10%, the power was then 0.2. If the real effect was different, the result less likely showed non-inferiority. To account for any potential drop off, 30 participants in each treatment group, were planned.||||||0.9353|||||||MMRM|||||||0.9353
72430988|NCT04447820|144373688|NON_INFERIORITY|Approximately 90 participants were planned. Assuming an effect size delta = 0, pooled SD = 21.38, an alpha = 0.05 (1-sided), and a non-inferiority limit of 15%, a sample size of 26 patients per treatment group provided a power of 0.80. In the case that the actual effect size delta was 10%, the power was then 0.2. If the real effect was different, the result less likely showed non-inferiority. To account for any potential drop off, 30 participants in each treatment group, were planned.||||||0.3099|||||||MMRM|||||||0.3099
72430989|NCT04447820|144373689|NON_INFERIORITY|Approximately 90 participants were planned. Assuming an effect size delta = 0, pooled SD = 21.38, an alpha = 0.05 (1-sided), and a non-inferiority limit of 15%, a sample size of 26 patients per treatment group provided a power of 0.80. In the case that the actual effect size delta was 10%, the power was then 0.2. If the real effect was different, the result less likely showed non-inferiority. To account for any potential drop off, 30 participants in each treatment group, were planned.||||||0.2098|||||||MMRM|||||||0.2098
72430990|NCT04447820|144373689|NON_INFERIORITY|Approximately 90 participants were planned. Assuming an effect size delta = 0, pooled SD = 21.38, an alpha = 0.05 (1-sided), and a non-inferiority limit of 15%, a sample size of 26 patients per treatment group provided a power of 0.80. In the case that the actual effect size delta was 10%, the power was then 0.2. If the real effect was different, the result less likely showed non-inferiority. To account for any potential drop off, 30 participants in each treatment group, were planned.||||||0.3688|||||||MMRM|||||||0.3688
72430991|NCT04447820|144373690|NON_INFERIORITY|Approximately 90 participants were planned. Assuming an effect size delta = 0, pooled SD = 21.38, an alpha = 0.05 (1-sided), and a non-inferiority limit of 15%, a sample size of 26 patients per treatment group provided a power of 0.80. In the case that the actual effect size delta was 10%, the power was then 0.2. If the real effect was different, the result less likely showed non-inferiority. To account for any potential drop off, 30 participants in each treatment group, were planned.||||||0.5647|||||||MMRM|||||||0.5647
72430992|NCT04447820|144373690|NON_INFERIORITY|Approximately 90 participants were planned. Assuming an effect size delta = 0, pooled SD = 21.38, an alpha = 0.05 (1-sided), and a non-inferiority limit of 15%, a sample size of 26 patients per treatment group provided a power of 0.80. In the case that the actual effect size delta was 10%, the power was then 0.2. If the real effect was different, the result less likely showed non-inferiority. To account for any potential drop off, 30 participants in each treatment group, were planned.||||||0.217|||||||MMRM|||||||0.2170
72430993|NCT04447820|144373691|NON_INFERIORITY|Approximately 90 participants were planned. Assuming an effect size delta = 0, pooled SD = 21.38, an alpha = 0.05 (1-sided), and a non-inferiority limit of 15%, a sample size of 26 patients per treatment group provided a power of 0.80. In the case that the actual effect size delta was 10%, the power was then 0.2. If the real effect was different, the result less likely showed non-inferiority. To account for any potential drop off, 30 participants in each treatment group, were planned.||||||0.2562|||||||MMRM|||||||0.2562
72430994|NCT04447820|144373691|NON_INFERIORITY|Approximately 90 participants were planned. Assuming an effect size delta = 0, pooled SD = 21.38, an alpha = 0.05 (1-sided), and a non-inferiority limit of 15%, a sample size of 26 patients per treatment group provided a power of 0.80. In the case that the actual effect size delta was 10%, the power was then 0.2. If the real effect was different, the result less likely showed non-inferiority. To account for any potential drop off, 30 participants in each treatment group, were planned.||||||0.4268|||||||MMRM|||||||0.4268
72363764|NCT04408989|144239032|EQUIVALENCE|"PK similarity was achieved if the 90% CIs for the biosimilar-to-reference ratios of Cmax were within the predefined 0.80-1.25 acceptance similarity criteria.~The PK parameter Cmax was log-transformed (base e) prior to analysis and was analysed using an ANCOVA model. The model included treatment as a fixed effect and body weight as a covariate."|Ratio of GLSM|0.983|||||TWO_SIDED|90.0|0.925|1.05|||||For the comparison, MB02 SP represents the numerator and US Avastin represents the denominator.|||1.05|0.925|
72430995|NCT03298815|144373698|SUPERIORITY|||||||0.375|||||||McNemar|||||||0.375
72430996|NCT03298815|144373699|SUPERIORITY|||||||0.391|||||||Wilcoxon (Mann-Whitney)|||||||0.391
72430997|NCT03298815|144373700|SUPERIORITY|||||||0.267|||||||Wilcoxon (Mann-Whitney)|||||||0.267
72430998|NCT03298815|144373701|SUPERIORITY|||||||0.445|||||||Wilcoxon (Mann-Whitney)|||||||0.445
72430999|NCT03298815|144373702|SUPERIORITY|||||||0.25|||||||Wilcoxon (Mann-Whitney)|||||||0.250
72431000|NCT03298815|144373703|SUPERIORITY||||||<|1|||||||Wilcoxon (Mann-Whitney)|||||||<1.00
72431001|NCT03298815|144373704|SUPERIORITY|||||||0.5|||||||Wilcoxon (Mann-Whitney)|||||||0.500
72431002|NCT03298815|144373705|SUPERIORITY|||||||0.563|||||||Wilcoxon (Mann-Whitney)|||||||0.563
72431003|NCT03298815|144373706|SUPERIORITY|||||||0.008|||||||Wilcoxon (Mann-Whitney)|||||||0.008
72431004|NCT03298815|144373707|SUPERIORITY|||||||0.156|||||||Wilcoxon (Mann-Whitney)|||||||0.156
72431005|NCT03298815|144373708|SUPERIORITY|||||||0.208|||||||Wilcoxon (Mann-Whitney)|||||||0.208
72431006|NCT03298815|144373709|SUPERIORITY|||||||0.594||||||30 day visit|Wilcoxon (Mann-Whitney)|||||||0.594
72431007|NCT03298815|144373709|SUPERIORITY|||||||0.469||||||60 day visit|Wilcoxon (Mann-Whitney)|||||||0.469
72431008|NCT03298815|144373709|SUPERIORITY|||||||0.75||||||100 day visit|Wilcoxon (Mann-Whitney)|||||||0.750
72431009|NCT03298815|144373710|SUPERIORITY|||||||0.063||||||30 day visit|Wilcoxon (Mann-Whitney)|||||||0.063
72431010|NCT03298815|144373710|SUPERIORITY||||||<|1||||||60 day visit|Wilcoxon (Mann-Whitney)|||||||<1.000
72431011|NCT03298815|144373710|SUPERIORITY|||||||0.25||||||100 day visit|Wilcoxon (Mann-Whitney)|||||||0.250
72431012|NCT00216320|144373758|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||||||<.001
72431013|NCT02753530|144373762|SUPERIORITY||Least Square (LS) Mean Difference|-0.99||||0.1146|TWO_SIDED|95.0|-2.23|0.24||Primary Estimand (Treatment Policy)|Mixed Models Analysis|||The baseline observation was the last observation recorded prior to the first dose of study medication. The change from baseline in IBMFRS total score was analyzed using a Mixed Models for Repeated Measures (MMRM) with treatment interacting with visit and trial site as factors. Baseline IBMFRS total score interacting with visit was further included as covariate. An unstructured covariance matrix was assumed.||0.24|-2.23|0.1146
72431014|NCT01125774|144373778|SUPERIORITY_OR_OTHER||Difference in percent incidence|-1.2|||||TWO_SIDED|95.0|-4.4|2.1|||Miettinen & Nurminen||Telcagepant percent incidence versus Placebo percent incidence|||2.1|-4.4|
72431015|NCT01125774|144373779|SUPERIORITY_OR_OTHER||Difference in percent incidence|-0.2|||||TWO_SIDED|95.0|-1.4|0.8|||Miettinen & Nurminen||Telcagepant percent incidence versus Placebo percent incidence|||0.8|-1.4|
72431016|NCT01125774|144373780|SUPERIORITY_OR_OTHER||Difference in percent incidence|0.6|||||TWO_SIDED|95.0|-0.5|1.6|||Miettinen & Nurminen||Telcagepant percent incidence versus Placebo percent incidence|||1.6|-0.5|
72431017|NCT01125774|144373782|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5||||0.13|TWO_SIDED|95.0|-1.1|0.1||α=0.0499|Longitudinal data analysis (LDA)||Difference is Telcagepant 140 mg versus Placebo|This measure tests the primary hypothesis, that telcagepant 140 mg is superior to placebo as measured by mean monthly headache days in participants with MRM or PMM||0.1|-1.1|0.130
72431018|NCT01125774|144373783|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3||||0.369|TWO_SIDED|95.0|-1.0|0.4||To control Type I error, formal significance of the test for treatment difference for this measure could only be achieved if the comparison corresponding to the primary hypothesis was significant at α=0.0499|LDA||Difference is Telcagepant 140 mg versus Placebo|||0.4|-1.0|0.369
72431019|NCT01125774|144373784|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|||<|0.001|TWO_SIDED|95.0|-0.5|-0.2||To control Type I error, formal significance of the test for treatment difference for this measure could only be achieved if the comparison corresponding to the primary hypothesis was significant at α=0.0499|LDA||Difference is Telcagepant 140 mg versus Placebo|||-0.2|-0.5|<0.001
72431020|NCT01125774|144373785|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|||<|0.001|TWO_SIDED|95.0|-0.5|-0.2||To control Type I error, formal significance of the test for treatment difference for this measure could only be achieved if the comparison corresponding to the primary hypothesis was significant at α=0.0499|LDA||Difference is Telcagepant 140 mg versus Placebo|||-0.2|-0.5|<0.001
72431021|NCT01125774|144373786|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.393|TWO_SIDED|95.0|-0.4|0.2||To control Type I error, formal significance of the test for treatment difference for this measure could only be achieved if the comparison corresponding to the primary hypothesis was significant at α=0.0499|LDA||Difference is Telcagepant 140 mg versus Placebo|||0.2|-0.4|0.393
72431022|NCT01641861|144373794|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.0|||||TWO_SIDED|95.0|0.1|7.3||||||||7.3|0.1|
72431023|NCT01641861|144373795|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.5|||||TWO_SIDED|95.0|0.9|12.8||||||||12.8|0.9|
72431024|NCT01641861|144373797|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.001
72431025|NCT01641861|144373798|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.001
72431026|NCT00354029|144373807|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||t-test, 2 sided|||||||>0.05
72431027|NCT00826280|144373808|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||P-Value is from the primary analysis using ANCOVA.|ANCOVA|||P-Value applies to 'Double-Blind - Baseline (Day 5 - Day 3)'.||||<0.001
72431028|NCT00826280|144373808|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||The unadjusted P-Values for pairwise differences should be used for interpretation only if the treatment effect's P-Value ≤ 0.05.|ANCOVA|||P-Value applies to 'Double-Blind - Baseline (Day 5 - Day 3)'.||||<0.001
72431029|NCT00826280|144373808|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||The unadjusted P-Values for pairwise differences should be used for interpretation only if the treatment effect's P-Value ≤ 0.05.|ANCOVA|||P-Value applies to 'Double-Blind - Baseline (Day 5 - Day 3)'.||||<0.001
72431030|NCT00826280|144373808|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9328||95.0||||The unadjusted P-Values for pairwise differences should be used for interpretation only if the treatment effect's P-Value ≤ 0.05.|ANCOVA|||P-Value applies to 'Double-Blind - Baseline (Day 5 - Day 3)'.||||0.9328
72431031|NCT00826280|144373809|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0011||95.0||||P-Value is from the primary analysis using ANCOVA.|ANCOVA|||P-Value applies to 'Double-Blind - Baseline (Day 5 - Day 3)'.||||0.0011
72431032|NCT00826280|144373809|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0034||95.0||||The unadjusted P-Values for pairwise differences should be used for interpretation only if the treatment effect's P-Value ≤ 0.05.|ANCOVA|||P-Value applies to 'Double-Blind - Baseline (Day 5 - Day 3)'.||||0.0034
72431033|NCT00826280|144373809|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||The unadjusted P-Values for pairwise differences should be used for interpretation only if the treatment effect's P-Value ≤ 0.05.|ANCOVA|||P-Value applies to 'Double-Blind - Baseline (Day 5 - Day 3)'.||||<0.001
72431034|NCT00826280|144373809|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5902||95.0||||The unadjusted P-Values for pairwise differences should be used for interpretation only if the treatment effect's P-Value ≤ 0.05.|ANCOVA|||P-Value applies to 'Double-Blind - Baseline (Day 5 - Day 3)'.||||0.5902
72431035|NCT00826280|144373810|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0037||95.0||||P-Value is from the primary analysis using ANCOVA.|ANCOVA|||P-Value applies to 'Double-Blind - Baseline (Day 5 - Day 3)'.||||0.0037
72431036|NCT00826280|144373810|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0089||95.0||||The unadjusted P-Values for pairwise differences should be used for interpretation only if the treatment effect's P-Value ≤ 0.05.|ANCOVA|||P-Value applies to 'Double-Blind - Baseline (Day 5 - Day 3)'.||||0.0089
72431037|NCT00826280|144373810|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0016||95.0||||The unadjusted P-Values for pairwise differences should be used for interpretation only if the treatment effect's P-Value ≤ 0.05.|ANCOVA|||P-Value applies to 'Double-Blind - Baseline (Day 5 - Day 3)'.||||0.0016
72431038|NCT00826280|144373810|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5654||95.0||||The unadjusted P-Values for pairwise differences should be used for interpretation only if the treatment effect's P-Value ≤ 0.05.|ANCOVA|||P-Value applies to 'Double-Blind - Baseline (Day 5 - Day 3)'.||||0.5654
72431039|NCT00826280|144373811|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||P-Value is from the primary analysis using ANCOVA.|ANCOVA|||P-Value applies to 'Double-Blind - Baseline (Day 5 - Day 3)'.||||<0.001
72431040|NCT00826280|144373811|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||The unadjusted P-Values for pairwise differences should be used for interpretation only if the treatment effect's P-Value ≤ 0.05.|ANCOVA|||P-Value applies to 'Double-Blind - Baseline (Day 5 - Day 3)'.||||<0.001
72363765|NCT04408989|144239032|EQUIVALENCE|"PK similarity was achieved if the 90% CIs for the biosimilar-to-reference ratios of Cmax were within the predefined 0.80-1.25 acceptance similarity criteria.~The PK parameter Cmax was log-transformed (base e) prior to analysis and was analysed using an ANCOVA model. The model included treatment as a fixed effect and body weight as a covariate."|Ratio of GLSM|1.05|||||TWO_SIDED|90.0|0.991|1.11|||||For the comparison, MB02 DM represents the numerator and US Avastin represents the denominator.|||1.11|0.991|
72363766|NCT05737069|144239061|EQUIVALENCE|The two products were considered to be bioequivalent if 90 percent (%) confidence intervals (CIs) for the geometric mean ratio (GMR) (Test/Reference) for AUC(0-t) were contained within the acceptance interval of 0.8 to 1.25.|Geometric Mean Ratio|1.0008|||||TWO_SIDED|90.0|0.9698|1.0327||||||||1.0327|0.9698|
72363767|NCT05737069|144239062|EQUIVALENCE|The two products were considered to be bioequivalent if 90% CIs for the GMR (Test/Reference) for AUC (0-inf) were contained within the acceptance interval of 0.8 to 1.25.|Geometric Mean Ratio|1.0023|||||TWO_SIDED|90.0|0.971|1.0346||||||||1.0346|0.9710|
72363768|NCT05737069|144239063|EQUIVALENCE|The two products were considered to be bioequivalent if 90% CIs for the GMR (Test/Reference) for Cmax were contained within the acceptance interval of 0.8 to 1.25.|Geometric Mean Ratio|0.9825|||||TWO_SIDED|90.0|0.9383|1.0288||||||||1.0288|0.9383|
72363769|NCT05737069|144239064|EQUIVALENCE|The two products were considered to be bioequivalent if 90% CIs for the GMR (Test/Reference) for AUC(0-t) were contained within the acceptance interval of 0.8 to 1.25.|Geometric Mean Ratio|0.9916|||||TWO_SIDED|90.0|0.9755|1.0081||||||||1.0081|0.9755|
72363770|NCT05737069|144239065|EQUIVALENCE|The two products were considered to be bioequivalent if 90% CIs for the GMR (Test/Reference) for AUC (0-inf) were contained within the acceptance interval of 0.8 to 1.25.|Geometric Mean Ratio|0.9776|||||TWO_SIDED|90.0|0.9432|1.0133||||||||1.0133|0.9432|
72363771|NCT05737069|144239066|EQUIVALENCE|The two products were considered to be bioequivalent if 90% CIs for the GMR (Test/Reference) for Cmax were contained within the interval of 0.8 to 1.25.|Geometric Mean Ratio|0.9982|||||TWO_SIDED|90.0|0.9431|1.0567||||||||1.0567|0.9431|
72363772|NCT04050553|144239084|SUPERIORITY||Least Square (LS) Mean Difference|-0.49||||0.7556|TWO_SIDED|95.0|-3.64|2.67|||Mixed Models Analysis|||||2.67|-3.64|0.7556
72363773|NCT04050553|144239085|SUPERIORITY||LS Mean Difference|-174.77||||0.0043|TWO_SIDED|95.0|-290.34|-59.21|||Mixed Models Analysis|||||-59.21|-290.34|0.0043
72363774|NCT04050553|144239086|SUPERIORITY||LS Mean Difference|-488.31|||<|0.0001|TWO_SIDED|95.0|-621.25|-355.36|||Mixed Models Analysis|||||-355.36|-621.25|<0.0001
72363775|NCT04050553|144239087|SUPERIORITY||LS Mean Difference|4.39||||0.0023|TWO_SIDED|95.0|1.69|7.08|||Mixed Models Analysis|||||7.08|1.69|0.0023
72363776|NCT04050553|144239088|SUPERIORITY||LS Mean Difference|-0.06||||0.0505|TWO_SIDED|95.0|-0.13|0.0|||Mixed Models Analysis|||For Overall Hypoglycemia Symptom Score at concentration of 100 mg/dL.||0.00|-0.13|0.0505
72363777|NCT04050553|144239088|SUPERIORITY||LS Mean Difference|-0.18||||0.0104|TWO_SIDED|95.0|-0.31|-0.05|||Mixed Models Analysis|||For Overall Hypoglycemia Symptom Score at concentration of 63 mg/dL.||-0.05|-0.31|0.0104
72431041|NCT00826280|144373811|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||The unadjusted P-Values for pairwise differences should be used for interpretation only if the treatment effect's P-Value ≤ 0.05.|ANCOVA|||P-Value applies to 'Double-Blind - Baseline (Day 5 - Day 3)'.||||<0.001
72363778|NCT04050553|144239088|SUPERIORITY||LS Mean Difference|-0.19||||0.0068|TWO_SIDED|95.0|-0.32|-0.06|||Mixed Models Analysis|||For Overall Hypoglycemia Symptom Score at concentration of 45 mg/dL.||-0.06|-0.32|0.0068
72363779|NCT04050553|144239088|SUPERIORITY||LS Mean Difference|-0.11||||0.2302|TWO_SIDED|95.0|-0.3|0.08|||Mixed Models Analysis|||For Overall Hypoglycemia Symptom Score at concentration of 72 mg/dL.||0.08|-0.30|0.2302
72363780|NCT04050553|144239089|SUPERIORITY||LS Mean Difference|-0.51||||0.8298|TWO_SIDED|95.0|-5.28|4.27|||Mixed Models Analysis|||For systolic blood pressure.||4.27|-5.28|0.8298
72363781|NCT04050553|144239089|SUPERIORITY||LS Mean Difference|1.96||||0.1516|TWO_SIDED|95.0|-0.76|4.67|||Mixed Models Analysis|||For diastolic blood pressure.||4.67|-0.76|0.1516
72363782|NCT04050553|144239090|SUPERIORITY||LS Mean Difference|-0.89||||0.5776|TWO_SIDED|95.0|-4.1|2.33|||Mixed Models Analysis|||||2.33|-4.10|0.5776
72363783|NCT04314284|144239101|SUPERIORITY|||||||0.15|||||||Kruskal-Wallis|||||||0.15
72363784|NCT04314284|144239102|SUPERIORITY|||||||0.35|||||||Kruskal-Wallis|||||||0.35
72363785|NCT04314284|144239103|SUPERIORITY|||||||0.22|||||||Chi-squared|||||||0.22
72363786|NCT04314284|144239107|SUPERIORITY|||||||0.65|||||||Kruskal-Wallis|||||||0.65
72363787|NCT04314284|144239108|SUPERIORITY|||||||0.52|||||||Kruskal-Wallis|||||||0.52
72363788|NCT04314284|144239109|SUPERIORITY|||||||0.51|||||||Chi-squared|||||||0.51
72363789|NCT04314284|144239112|OTHER|2-sided||||||0.71|||||||t-test, 2 sided|||||||0.71
72363790|NCT04314284|144239113|OTHER|2-sided||||||0.12|||||||t-test, 2 sided|||||||0.12
72363791|NCT04314284|144239115|SUPERIORITY|||||||0.66|||||||Kruskal-Wallis|||||||0.66
72363792|NCT02201953|144239135|NON_INFERIORITY_OR_EQUIVALENCE|Primary analyses consisted of non-inferiority test of Group 1 (SOF/VEL 12 weeks) versus Group 2 (SOF+RBV 24 weeks) at the 0.05 significance level. Non-inferiority was assessed using the conventional confidence interval approach and a non-inferiority margin of 10% was applied. The two-sided 95% confidence intervals was constructed using stratum-adjusted Mantel-Haenszel proportions, stratified by the randomization stratification factors (i.e cirrhosis status and prior treatment experience)|Difference in proportions|14.4|||||TWO_SIDED|95.0|9.2|19.6|||||Difference in proportions between treatment groups and associated 95% confidence intervals (CI) are calculated based on stratum-adjusted Mantel-Haenszel proportions.|||19.6|9.2|
72363793|NCT02201953|144239135|SUPERIORITY_OR_OTHER||||||<|0.001||||||P-value was from the Cochran-Mantel-Haenszel test stratified by cirrhosis status and prior HCV treatment experience.|Cochran-Mantel-Haenszel|||If the lower bound of 95% CI on the difference was \> -10%, the p-value tested for the superiority of SOF/VEL for 12 weeks over SOF+RBV for 24 weeks. Superiority was demonstrated if the two-sided p-value is less than 0.05.||||<0.001
72363794|NCT05523089|144239141|SUPERIORITY||Hodges-Lehmann estimator|-1.2||||0.039|TWO_SIDED|95.0|-5.7|0.0||alpha = 0.025 one-sided|Wilcoxon (Mann-Whitney)|||||0.0|-5.7|0.0390
72431042|NCT00826280|144373811|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4246||95.0||||The unadjusted P-Values for pairwise differences should be used for interpretation only if the treatment effect's P-Value ≤ 0.05.|ANCOVA|||P-Value applies to 'Double-Blind - Baseline (Day 5 - Day 3)'.||||.4246
72431043|NCT04003974|144373927|OTHER|Mean DUX4 activity was derived for each participant at each time point (Baseline and post-Baseline) based on normalized gene expression values for the 6-gene panel. Changes from Baseline to post-Baseline were analyzed using an ANCOVA model.|Least square mean difference|0.4284||||0.5621|TWO_SIDED|95.0|-1.0376|1.8945|||ANCOVA||Results are expressed as difference in Least-Squares (LS) means of the changes from Baseline to post-Baseline in DUX4 activity for each group, losmapimod and placebo.|||1.8945|-1.0376|0.5621
72431044|NCT02240680|144373966|SUPERIORITY||Mean Difference (Final Values)|-0.63|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001|TWO_SIDED|95.0|-0.81|-0.46|||Mixed Models Analysis|Mixed model repeated measures(MMRM) included treatment, week and interaction as fixed effects, baseline HbA1c, daily basal insulin dose as covariates|Adjusted mean of all differences between HbA1c at baseline and after 24 weeks. It is based on all patients in the model (not only patients with a baseline and week 24 measurement).||MMRM including fixed effects treatment , week and treatment by week interaction linear covariates baseline HbA1c , baseline daily basal insulin and baseline HbA1c by week interaction and random effect for patient. Within-patient errors are modelled by unstructured covariance matrix. Adjusted mean is based on all patients in the model (not only patients with a baseline and week 24 measurement).|-0.46|-0.81|< 0.0001
72431045|NCT02240680|144373967|OTHER||Odds Ratio (OR)|1.464|STANDARD_ERROR_OF_MEAN|0.397||0.1594|TWO_SIDED|95.0|0.861|2.491|||Regression, Logistic|A logistic regression model with treatment as fixed effect and baseline HbA1c and baseline daily basal insulin dose as linear covariates was applied.|The dispersion value standard error of the mean is actually standard error for odds ratio.|For any hypoglycemia event accompanied by prespecified glucose value||2.491|0.861|0.1594
72431046|NCT02240680|144373967|OTHER||Odds Ratio (OR)|1.149|STANDARD_ERROR_OF_MEAN|0.377||0.672|TWO_SIDED|95.0|0.604|2.188|||Regression, Logistic|A logistic regression model with treatment as fixed effect and baseline HbA1c and baseline daily basal insulin dose as linear covariates was applied.|The dispersion value standard error of the mean is actually standard error for odds ratio.|For glucose value \< 54mg/dL according American Diabetes Association definition of clinically significant hypoglycaemia||2.188|0.604|0.6720
72431047|NCT02240680|144373968|OTHER||Odds Ratio (OR)|5.018|STANDARD_ERROR_OF_MEAN|1.818|<|0.0001|TWO_SIDED|95.0|2.468|10.206|||Regression, Logistic|A logistic regression model with treatment as fixed effect and baseline HbA1c and baseline daily basal insulin dose as linear covariates was applied.|The dispersion value standard error of the mean is actually standard error of odds ratio|||10.206|2.468|< 0.0001
72431048|NCT02240680|144373969|OTHER||Odds Ratio (OR)|4.689|STANDARD_ERROR_OF_MEAN|1.519|<|0.0001|TWO_SIDED|95.0|2.485|8.848|||Regression, Logistic|A logistic regression model with treatment as fixed effect and baseline HbA1c and baseline daily basal insulin dose as linear covariates was applied.|The dispersion value standard error of the mean is actually standard error of odds ratio|||8.848|2.485|< 0.0001
72431049|NCT02240680|144373970|OTHER||Odds Ratio (OR)|3.731|STANDARD_ERROR_OF_MEAN|0.92|<|0.0001|TWO_SIDED|95.0|2.302|6.048|||Regression, Logistic|A logistic regression model with treatment as fixed effect and baseline HbA1c and baseline daily basal insulin dose as linear covariates was applied.|The dispersion value standard error of the mean is actually standard error of odds ratio|||6.048|2.302|< 0.0001
72431050|NCT02240680|144373971|SUPERIORITY||Mean Difference (Final Values)|-11.5|STANDARD_ERROR_OF_MEAN|4.8||0.0178|TWO_SIDED|95.0|-21.0|-2.0|||Mixed Models Analysis|Mixed model repeated measures(MMRM) included treatment, week and interaction as fixed effects, baseline HbA1c, FPG, daily insulin dose as covariates|Adjusted mean of all differences between HbA1c at baseline and after 24 weeks. It is based on all patients in the model (not only patients with a baseline and week 24 measurement).||MMRM including fixed effects treatment, week and treatment by week interaction, linear covariates baseline HbA1c, baseline daily basal insulin, baseline FPG and baseline FPG by week interaction and random effect for patient. Within-patient errors are modelled by unstructured covariance matrix. Adjusted mean is based on all patients in the model (not only patients with a baseline and week 24 measurement).|-2.0|-21.0|0.0178
72431051|NCT00562965|144373972|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.19||||0.0358|TWO_SIDED|95.0|0.04|1.02|||Cox proportional hazard regression model|A 2-sided 5% significance level on a stratified Cox proportional hazard regression model was used.|In this regression model, treatment arm was the covariate and the strata (number of prior regimens, investigator's choice of therapy and geographical region) over which participants were stratified prior to randomization were the variables.|To detect a hazard ratio of 0.77 with 85% power using a 2-sided log-rank test at the 5% significance level, it was planned that approximately 978 participants were needed to be randomized but due to premature termination only 29 participants were randomized.||1.02|0.04|0.0358
72431052|NCT00562965|144373973|SUPERIORITY_OR_OTHER|||||||0.0801|TWO_SIDED||||||Fisher Exact|||||||0.0801
72431053|NCT00562965|144373974|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.3||||0.1727|TWO_SIDED|95.0|0.05|1.81|||Cox proportional hazard regression model|Stratified Cox proportional hazard regression model was utilized.|In this regression model, treatment arm was the covariate and the strata (number of prior regimens, investigator's choice of therapy and geographical region) over which participants were stratified prior to randomization were the variables.|||1.81|0.05|0.1727
72431054|NCT00848211|144373998|SUPERIORITY_OR_OTHER|||||||0.008||95.0|||||ANOVA|||||||0.008
72431055|NCT00848211|144374000|SUPERIORITY_OR_OTHER|||||||0.045||95.0|||||ANOVA|||||||0.045
72431056|NCT02444143|144374020|OTHER|||||||0.29|||||||t-test, 2 sided|||||||0.29
72431057|NCT02444143|144374021|OTHER|||||||0.9|||||||t-test, 2 sided|||||||0.90
72431058|NCT03582137|144374022|SUPERIORITY||Mean Difference (Net)|-1.8049||||0.3785|TWO_SIDED|95.0|-5.8839|2.2741|||Mixed Models Analysis|||||2.2741|-5.8839|0.3785
72431059|NCT03582137|144374026|SUPERIORITY||Mean Difference (Net)|-4.4254||||0.2712|TWO_SIDED|95.0|-12.4018|3.551|||Mixed Models Analysis|||||3.5510|-12.4018|0.2712
72431060|NCT03582137|144374027|SUPERIORITY||Mean Difference (Net)|0.3133||||0.8974|TWO_SIDED|95.0|-4.5414|5.168|||Mixed Models Analysis|||||5.1680|-4.5414|0.8974
72431061|NCT03582137|144374028|SUPERIORITY||Mean Difference (Net)|0.1505||||0.4643|TWO_SIDED|95.0|-0.2882|0.5892|||Mixed Models Analysis|||||0.5892|-0.2882|0.4643
72431062|NCT03582137|144374029|SUPERIORITY||Mean Difference (Net)|-0.1188||||0.6245|TWO_SIDED|95.0|-0.6019|0.3644|||Mixed Models Analysis|||||0.3644|-0.6019|0.6245
72431063|NCT03582137|144374035|SUPERIORITY||Mean Difference (Net)|-0.3341||||0.5921|TWO_SIDED|95.0|-1.5749|0.9068|||Mixed Models Analysis|||||0.9068|-1.5749|0.5921
72431064|NCT03582137|144374036|SUPERIORITY||Mean Difference (Net)|1.9352||||0.1016|TWO_SIDED|95.0|-0.4372|4.3076|||Mixed Models Analysis|||||4.3076|-0.4372|0.1016
72431065|NCT03582137|144374037|SUPERIORITY||Mean Difference (Net)|19.686||||0.0661|TWO_SIDED|95.0|-1.3733|40.7452|||Mixed Models Analysis|||||40.7452|-1.3733|0.0661
72431066|NCT03582137|144374038|SUPERIORITY||Mean Difference (Net)|-3.2214||||0.088|TWO_SIDED|95.0|-6.9381|0.4953|||Mixed Models Analysis|||||0.4953|-6.9381|0.0880
72431067|NCT03582137|144374039|SUPERIORITY||Mean Difference (Net)|-4.9836||||0.2827|TWO_SIDED|95.0|-14.2093|4.2421|||Mixed Models Analysis|||||4.2421|-14.2093|0.2827
72431068|NCT03582137|144374040|SUPERIORITY||Mean Difference (Net)|0.576||||0.7703|TWO_SIDED|95.0|-3.3697|4.5216|||Mixed Models Analysis|||||4.5216|-3.3697|0.7703
72431069|NCT03582137|144374041|SUPERIORITY||Mean Difference (Net)|-0.8834||||0.1874|TWO_SIDED|95.0|-2.2172|0.4504|||Mixed Models Analysis|||||0.4504|-2.2172|0.1874
72363795|NCT05523089|144239143|SUPERIORITY||Mean Difference (Net)|-1.4||||0.0185|TWO_SIDED|95.0|-2.9|0.0||alpha = 0.025 one-sided|Wilcoxon (Mann-Whitney)|||||-0.0|-2.9|0.0185
72363796|NCT05523089|144239145|SUPERIORITY|||||||0.0613||||||alpha = 0.025 one-sided|Gehan-Wilcoxon|||||||0.0613
72363797|NCT05523089|144239146|SUPERIORITY||Hodges-Lehmann estimator|0.0||||0.1587|TWO_SIDED|95.0|-2.4|0.0||alpha = 0.025 one-sided|Wilcoxon (Mann-Whitney)|||||0.0|-2.4|0.1587
72363798|NCT05523089|144239148|SUPERIORITY||Mean Difference (Net)|-1.1||||0.0236|TWO_SIDED|95.0|-2.0|-0.1||alpha = 0.025 one-sided|Wilcoxon (Mann-Whitney)|||||-0.1|-2.0|0.0236
72431070|NCT03582137|144374044|SUPERIORITY||Mean Difference (Net)|1.2993||||0.1646|TWO_SIDED|95.0|-0.5533|3.1519|||Mixed Models Analysis|||||3.1519|-0.5533|0.1646
72431071|NCT03582137|144374045|SUPERIORITY||Mean Difference (Net)|-1.7519||||0.1093|TWO_SIDED|95.0|-3.9082|0.4045|||Mixed Models Analysis|||||0.4045|-3.9082|0.1093
72431072|NCT03582137|144374046|SUPERIORITY||Mean Difference (Net)|1.3532||||0.1819|TWO_SIDED|95.0|-0.6511|3.3576|||Mixed Models Analysis|||||3.3576|-0.6511|0.1819
72431073|NCT03582137|144374047|SUPERIORITY||Mean Difference (Net)|0.9667||||0.2282|TWO_SIDED|95.0|-0.6287|2.5621|||Mixed Models Analysis|||||2.5621|-0.6287|0.2282
72431074|NCT03582137|144374048|SUPERIORITY||Mean Difference (Net)|-0.2614||||0.6167|TWO_SIDED|95.0|-1.3002|0.7775|||Mixed Models Analysis|||||0.7775|-1.3002|0.6167
72431075|NCT03582137|144374049|SUPERIORITY||Mean Difference (Net)|0.3067||||0.8378|TWO_SIDED|95.0|-2.6765|3.2899|||Mixed Models Analysis|||||3.2899|-2.6765|0.8378
72431076|NCT03582137|144374051|SUPERIORITY||Mean Difference (Net)|0.3237||||0.2103|TWO_SIDED|95.0|-0.188|0.8353|||Mixed Models Analysis|||||0.8353|-0.1880|0.2103
72431077|NCT03582137|144374052|SUPERIORITY||Mean Difference (Net)|-0.504||||0.7197|TWO_SIDED|95.0|-3.3015|2.2934|||Mixed Models Analysis|||||2.2934|-3.3015|0.7197
72431078|NCT03582137|144374053|SUPERIORITY||Mean Difference (Net)|2.6158||||0.0686|TWO_SIDED|95.0|-0.2058|5.4373|||Mixed Models Analysis|||||5.4373|-0.2058|0.0686
72431079|NCT03582137|144374054|SUPERIORITY||Mean Difference (Net)|2.7891||||0.2339|TWO_SIDED|95.0|-1.8523|7.4304|||Mixed Models Analysis|||||7.4304|-1.8523|0.2339
72431080|NCT03582137|144374055|SUPERIORITY||Mean Difference (Net)|0.9536||||0.7557|TWO_SIDED|95.0|-5.1655|7.0727|||Mixed Models Analysis|||||7.0727|-5.1655|0.7557
72431081|NCT03582137|144374057|SUPERIORITY||Mean Difference (Net)|0.05126||||0.915|TWO_SIDED|95.0|-0.9086|1.0111|||Mixed Models Analysis|||||1.0111|-0.9086|0.9150
72431082|NCT03582137|144374058|SUPERIORITY||Mean Difference (Net)|-0.6699||||0.6164|TWO_SIDED|95.0|-3.3316|1.9918|||Mixed Models Analysis|||||1.9918|-3.3316|0.6164
72431083|NCT03582137|144374059|SUPERIORITY||Mean Difference (Net)|-0.1358||||0.755|TWO_SIDED|95.0|-1.0028|0.7312|||Mixed Models Analysis|||||0.7312|-1.0028|0.7550
72431084|NCT03582137|144374060|SUPERIORITY||Mean Difference (Net)|-0.09605||||0.9016|TWO_SIDED|95.0|-1.6449|1.4528|||Mixed Models Analysis|||||1.4528|-1.6449|0.9016
72431085|NCT03582137|144374061|SUPERIORITY||Mean Difference (Net)|-0.3217||||0.9219|TWO_SIDED|95.0|-6.8584|6.2151|||Mixed Models Analysis|||||6.2151|-6.8584|0.9219
72431086|NCT03582137|144374062|SUPERIORITY||Mean Difference (Net)|0.02897||||0.3178|TWO_SIDED|95.0|-0.02857|0.08651|||Mixed Models Analysis|||||0.08651|-0.02857|0.3178
72431087|NCT03582137|144374067|SUPERIORITY||Mean Difference (Net)|0.2288||||0.7693|TWO_SIDED|95.0|-1.325|1.7825|||Mixed Models Analysis|||||1.7825|-1.3250|0.7693
72431088|NCT03582137|144374068|SUPERIORITY||Mean Difference (Net)|-0.8121||||0.5285|TWO_SIDED|95.0|-3.3743|1.7501|||Mixed Models Analysis|||||1.7501|-3.3743|0.5285
72431089|NCT03582137|144374069|SUPERIORITY||Mean Difference (Net)|-0.02525||||0.9463|TWO_SIDED|95.0|-0.7717|0.7212|||Mixed Models Analysis|||||0.7212|-0.7717|0.9463
72431090|NCT03582137|144374070|SUPERIORITY||Mean Difference (Net)|-0.3042||||0.4362|TWO_SIDED|95.0|-1.0817|0.4732|||Mixed Models Analysis|||||0.4732|-1.0817|0.4362
72431091|NCT03582137|144374071|SUPERIORITY||Mean Difference (Net)|-0.06489||||0.9327|TWO_SIDED|95.0|-1.5957|1.4659|||Mixed Models Analysis|||||1.4659|-1.5957|0.9327
72431092|NCT03582137|144374074|SUPERIORITY||Mean Difference (Net)|-0.2763||||0.4401|TWO_SIDED|95.0|-0.988|0.4354|||Mixed Models Analysis|||||0.4354|-0.9880|0.4401
72431093|NCT03582137|144374075|SUPERIORITY||Mean Difference (Net)|-0.8319||||0.8085|TWO_SIDED|95.0|-7.6835|6.0197|||Mixed Models Analysis|||||6.0197|-7.6835|0.8085
72431094|NCT03582137|144374077|SUPERIORITY||Mean Difference (Net)|0.02673||||0.9674|TWO_SIDED|95.0|-1.2757|1.3292|||Mixed Models Analysis|||||1.3292|-1.2757|0.9674
72431095|NCT03582137|144374079|SUPERIORITY||Mean Difference (Net)|-46.92||||0.1128|TWO_SIDED|95.0|-105.51|11.68|||Mixed Models Analysis|||||11.68|-105.51|0.1128
72431096|NCT00483262|144374101|SUPERIORITY_OR_OTHER||>= grade 3 adverse event proportion|0.9|||||TWO_SIDED|90.0|0.72|0.98|||||Estimated proportion of patients with a adverse event of grade 3 or higher.|Single Arm Study||.98|.72|
72431097|NCT00483262|144374101|SUPERIORITY_OR_OTHER||toxicity grade >=3 proportion|0.79|||||TWO_SIDED|90.0|0.66|0.89|||||No comparison. Estimate the proportion of patients with grade 3 or higher toxicity.|Phase II toxicity||.89|.66|
72431098|NCT00483262|144374102|SUPERIORITY_OR_OTHER||response rate of PR or better|0.1|||||TWO_SIDED|90.0|0.02|0.28|||||Response of PR or better|Phase I part of this phase I/II study||.28|.02|
72431099|NCT00483262|144374102|SUPERIORITY_OR_OTHER||response rate of PR or better|0.33|||||TWO_SIDED|90.0|0.21|0.47|||||Response of PR or better|Phase II part of this phase I/II study.||0.47|0.21|
72431100|NCT02303574|144374107|OTHER|Dose proportionality was analyzed by power model. Slope parameter was obtained via linear least squares.|Slope|1.287|STANDARD_ERROR_OF_MEAN|0.05085|||TWO_SIDED|95.0|1.183|1.391||||||||1.391|1.183|
72363799|NCT05523089|144239150|SUPERIORITY|||||||0.1282||||||alpha = 0.025 one-sided|Gehan-Wilcoxon|||||||0.1282
72363800|NCT05523089|144239151|SUPERIORITY||Mean Difference (Net)|-5.4||||0.2877|TWO_SIDED|95.0|-11.2|0.3||alpha = 0.025 one-sided|Wilcoxon (Mann-Whitney)|||||0.3|-11.2|0.2877
72363801|NCT05523089|144239153|SUPERIORITY||Mean Difference (Net)|-1.8||||0.2517|TWO_SIDED|95.0|-4.1|0.6||alpha = 0.025 one-sided|Wilcoxon (Mann-Whitney)|||||0.6|-4.1|0.2517
72363802|NCT05523089|144239157|SUPERIORITY|||||||0.9024||||||alpha = 0.025 one-sided|Gehan-Wilcoxon|||||||0.9024
72363803|NCT05523089|144239158|SUPERIORITY|||||||0.0248||||||alpha = 0.025 one-sided|Fisher Exact|||||||0.0248
72363804|NCT05523089|144239160|SUPERIORITY|||||||0.1224||||||alpha = 0.025 one-sided|Fisher Exact|||||||0.1224
72363805|NCT05523089|144239162|SUPERIORITY|||||||0.1023||||||alpha = 0.025 one-sided|Fisher Exact|||||||0.1023
72363806|NCT05523089|144239164|SUPERIORITY|||||||0.1477||||||alpha = 0.025 one-sided|Fisher Exact|||||||0.1477
72363807|NCT05523089|144239166|SUPERIORITY|||||||0.1645||||||alpha = 0.025 one-sided|Fisher Exact|||||||0.1645
72363808|NCT02892344|144239237|SUPERIORITY||Mean Difference (Net)|0.182|||<|0.001|TWO_SIDED|95.0|0.148|0.217|||Mixed Models Analysis|||||0.217|0.148|<0.001
72363809|NCT02892344|144239238|SUPERIORITY||Mean Difference (Net)|-0.218|||<|0.001|TWO_SIDED|95.0|-0.293|-0.143|||Mixed Models Analysis|||||-0.143|-0.293|<0.001
72363810|NCT02892344|144239239|SUPERIORITY||Mean Difference (Net)|0.132|||<|0.001|TWO_SIDED|95.0|0.105|0.158|||Mixed Models Analysis|||||0.158|0.105|<0.001
72431101|NCT02303574|144374107|OTHER|Effect of food analysis by linear mixed effects ANOVA model with fixed effect of fasting status.|Ratio (%)|90.72|||||TWO_SIDED|90.0|83.72|98.31||||||||98.31|83.72|
72363811|NCT02892344|144239240|SUPERIORITY||Mean Difference (Net)|0.176|||<|0.001|TWO_SIDED|95.0|0.145|0.207|||Mixed Models Analysis|||||0.207|0.145|<0.001
72363812|NCT02892344|144239241|SUPERIORITY||Mean Difference (Net)|0.1|||<|0.001|TWO_SIDED|95.0|0.061|0.139|||Mixed Models Analysis|||Pre-dose trough FVC||0.139|0.061|<0.001
72363813|NCT02892344|144239241|SUPERIORITY||Mean Difference (Net)|0.288|||<|0.001|TWO_SIDED|95.0|0.231|0.345|||Mixed Models Analysis|||Pre-dose trough FEF25-75%||0.345|0.231|<0.001
72363814|NCT02892344|144239242|SUPERIORITY||Mean Difference (Net)|27.2|||<|0.001|TWO_SIDED|95.0|22.1|32.4|||Mixed Models Analysis|||Mean Morning PEF||32.4|22.1|<0.001
72363815|NCT02892344|144239242|SUPERIORITY||Mean Difference (Net)|26.1|||<|0.001|TWO_SIDED|95.0|21.0|31.2|||Mixed Models Analysis|||Mean Evening PEF||31.2|21.0|<0.001
72363816|NCT02892344|144239245|SUPERIORITY||Mean Difference (Net)|-0.204|||<|0.001|TWO_SIDED|95.0|-0.277|-0.131|||Mixed Models Analysis|||||-0.131|-0.277|<0.001
72363817|NCT02892344|144239246|SUPERIORITY||Mean Difference (Net)|-0.11|||<|0.001|TWO_SIDED|95.0|-0.16|-0.05|||Mixed Models Analysis|||Night-time number of puffs of rescue medication||-0.05|-0.16|<0.001
72363818|NCT02892344|144239246|SUPERIORITY||Mean Difference (Net)|-0.15|||<|0.001|TWO_SIDED|95.0|-0.22|-0.08|||Mixed Models Analysis|||Daytime number of puffs of rescue medication||-0.08|-0.22|<0.001
72363819|NCT02892344|144239247|SUPERIORITY||Mean Difference (Net)|8.1|||<|0.001|TWO_SIDED|95.0|4.3|11.8|||Mixed Models Analysis|||||11.8|4.3|<0.001
72363820|NCT02892344|144239248|SUPERIORITY||Mean Difference (Net)|0.149|||<|0.001|TWO_SIDED|95.0|0.064|0.234|||Mixed Models Analysis|||||0.234|0.064|<0.001
72363821|NCT02892344|144239251|SUPERIORITY||Hazard Ratio (HR)|0.29|||<|0.001|TWO_SIDED|95.0|0.14|0.59|||Regression, Cox|||||0.59|0.14|<0.001
72363822|NCT01084655|144239305|SUPERIORITY_OR_OTHER||Ratio of Geometric Least Square(LS)Means|1.204|||||TWO_SIDED|90.0|0.87|1.666||||||ANOVA with dose level as a fixed effect and participant as a random effect.||1.666|0.870|
72363823|NCT01084655|144239306|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Means|1.074|||||TWO_SIDED|90.0|0.793|1.455||||||ANOVA with dose level as a fixed effect and participant as a random effect.||1.455|0.793|
72363824|NCT01084655|144239309|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Means|1.066|||||TWO_SIDED|90.0|0.802|1.417||||||ANOVA with dose level as a fixed effect and participant as a random effect.||1.417|0.802|
72363825|NCT01084655|144239310|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Means|1.068|||||TWO_SIDED|90.0|0.955|1.195||||||ANOVA with dose level as a fixed effect and participant as a random effect.||1.195|0.955|
72363826|NCT01074814|144239325|OTHER||||||||||||||||||Results for the primary objective - evaluation of GMI - were presented with descriptive statistics as the ration of PFS on current therapy over the PFS on latest therapy. The percentage of patients with GMI greater than 1.3 was displayed along with its corresponding 95% exact confidence interval.|||
72363827|NCT05024032|144239332|SUPERIORITY||LS Mean Difference|-12.0|||<|0.001|TWO_SIDED|95.0|-14.8|-9.3|||Mixed Models Analysis|||||-9.3|-14.8|<0.001
72363828|NCT05024032|144239332|SUPERIORITY||LS Mean Difference|-17.5|||<|0.001|TWO_SIDED|95.0|-20.3|-14.8|||Mixed Models Analysis|||||-14.8|-20.3|<0.001
72363829|NCT05024032|144239333|SUPERIORITY||Odds Ratio (OR)|23.11|||<|0.001|TWO_SIDED|95.0|8.8|60.69|||Regression, Logistic|||||60.69|8.80|<0.001
72363830|NCT05024032|144239333|SUPERIORITY||Odds Ratio (OR)|26.53|||<|0.001|TWO_SIDED|95.0|9.61|73.24|||Regression, Logistic|||||73.24|9.61|<0.001
72363831|NCT05024032|144239334|SUPERIORITY||LS Mean Difference|-7.2|||<|0.001|TWO_SIDED|95.0|-8.8|-5.5|||Mixed Models Analysis|||||-5.5|-8.8|<0.001
72363832|NCT05024032|144239334|SUPERIORITY||LS Mean Difference|-9.2|||<|0.001|TWO_SIDED|95.0|-10.9|-7.5|||Mixed Models Analysis|||||-7.5|-10.9|<0.001
72363833|NCT05024032|144239335|SUPERIORITY||Odds Ratio (OR)|13.19|||<|0.001|TWO_SIDED|95.0|5.63|30.89|||Regression, Logistic|||||30.89|5.63|<0.001
72363834|NCT05024032|144239335|SUPERIORITY||Odds Ratio (OR)|28.58|||<|0.001|TWO_SIDED|95.0|11.23|72.71|||Regression, Logistic|||||72.71|11.23|<0.001
72363835|NCT05024032|144239336|SUPERIORITY||Odds Ratio (OR)|25.64|||<|0.001|TWO_SIDED|95.0|6.68|98.49|||Regression, Logistic|||||98.49|6.68|<0.001
72363836|NCT05024032|144239336|SUPERIORITY||Odds Ratio (OR)|69.79|||<|0.001|TWO_SIDED|95.0|17.69|275.37|||Regression, Logistic|||||275.37|17.69|<0.001
72363837|NCT05024032|144239337|SUPERIORITY||LS Mean Difference|-9.2|||<|0.001|TWO_SIDED|95.0|-11.5|-6.9|||Mixed Models Analysis|||||-6.9|-11.5|<0.001
72363838|NCT05024032|144239337|SUPERIORITY||LS Mean Difference|-13.7|||<|0.001|TWO_SIDED|95.0|-16.0|-11.3|||Mixed Models Analysis|||||-11.3|-16.0|<0.001
72363839|NCT05024032|144239338|SUPERIORITY||LS Mean Difference|-10.9|||<|0.001|TWO_SIDED|95.0|-13.5|-8.3|||Mixed Models Analysis|||||-8.3|-13.5|<0.001
72363840|NCT05024032|144239338|SUPERIORITY||LS Mean Difference|-16.0|||<|0.001|TWO_SIDED|95.0|-18.6|-13.4|||Mixed Models Analysis|||||-13.4|-18.6|<0.001
72431102|NCT02303574|144374108|OTHER|Time dependency was assessed via linear mixed effects ANOVA model with fixed effects of dose level, day and dose-level-by-day interaction.|Ratio (%)|159.4|||||TWO_SIDED|90.0|140.61|180.7||||||||180.70|140.61|
72431103|NCT02303574|144374108|OTHER|Time dependency was assessed via linear mixed effects ANOVA model with fixed effects of dose level, day and dose-level-by-day interaction.|Ratio (%)|151.82|||||TWO_SIDED|90.0|138.23|166.74||||||||166.74|138.23|
72431104|NCT02303574|144374108|OTHER|Time dependency was assessed via linear mixed effects ANOVA model with fixed effects of dose level, day and dose-level-by-day interaction.|Ratio (%)|158.68|||||TWO_SIDED|90.0|146.67|171.67||||||||171.67|146.67|
72431105|NCT02303574|144374109|OTHER|Dose proportionality was analyzed by power model. Slope parameter was obtained via linear least squares.|Slope|1.228|STANDARD_ERROR_OF_MEAN|0.1329|||TWO_SIDED|95.0|0.9513|1.504||||||||1.504|0.9513|
72431106|NCT02303574|144374109|OTHER|ime dependency was assessed via linear mixed effects ANOVA model with fixed effects of dose level, day and dose-level-by-day interaction.|Ratio (%)|159.4|||||TWO_SIDED|90.0|140.61|180.7||||||||180.70|140.61|
72431107|NCT02303574|144374109|OTHER|ime dependency was assessed via linear mixed effects ANOVA model with fixed effects of dose level, day and dose-level-by-day interaction.|Ratio (%)|151.82|||||TWO_SIDED|90.0|138.23|166.74||||||||166.74|138.23|
72431108|NCT02303574|144374109|OTHER|ime dependency was assessed via linear mixed effects ANOVA model with fixed effects of dose level, day and dose-level-by-day interaction.|Ratio (%)|158.68|||||TWO_SIDED|90.0|146.67|171.67||||||||171.67|146.67|
72431109|NCT02303574|144374110|OTHER||Slope|1.302|STANDARD_ERROR_OF_MEAN|0.05056|||TWO_SIDED|95.0|1.198|1.406||||||Dose proportionality was analyzed by power model. Slope parameter was obtained via linear least squares.||1.406|1.198|
72363841|NCT05024032|144239339|SUPERIORITY||LS Mean Difference|-3.9|||<|0.001|TWO_SIDED|95.0|-4.8|-3.1|||Mixed Models Analysis|||||-3.1|-4.8|<0.001
72431110|NCT02303574|144374110|OTHER|Effect of food analysis by linear mixed effects ANOVA model with fixed effect of fasting status.|Ratio (%)|64.14|||||TWO_SIDED|90.0|55.07|74.7||||||||74.70|55.07|
72431111|NCT02303574|144374111|OTHER|Dose proportionality was analyzed by power model. Slope parameter was obtained via linear least squares.|Slope|1.157|STANDARD_ERROR_OF_MEAN|0.1098|||TWO_SIDED|95.0|0.9285|1.385||||||||1.385|0.9285|
72431112|NCT00783718|144374163|SUPERIORITY_OR_OTHER||Risk Difference (RD)|21.7|||<|0.0001|TWO_SIDED|95.0|11.6|31.7|||Cochran-Mantel-Haenszel|||The primary comparison of the Induction Phase was tested using the Cochran-Mantel-Haenszel (CMH) chi-square test at a 5% significance level, with stratification according to the stratification factors (concomitant use of oral corticosteroids and previous exposure to tumor necrosis factor alpha (TNFα) antagonists or concomitant immunomodulator \[6-mercaptopurine or azathioprine\] use).||31.7|11.6|< 0.0001
72431113|NCT00783718|144374164|SUPERIORITY_OR_OTHER||Risk Difference (RD)|26.1|||<|0.0001|TWO_SIDED|95.0|14.9|37.2||P-value is based on the CMH chi-square test, with 3 stratification factors: concomitant use of oral corticosteroids; previous exposure to TNFα antagonists or concomitant immunomodulator use; enrollment in Cohort 1 or 2 in the Induction Phase.|Cochran-Mantel-Haenszel|||The Hochberg method was applied to control the overall Type I error rate at a 5% significance level. If both P-values were ≤ 0.05, both dose regimens were to be declared significant. If 1 of the P-values for the 2 dose comparisons was \> 0.05, the other P-value was to be tested at the 0.025 level and declared significant only if the P-value was ≤ 0.025. If neither dose was declared significant for the primary endpoint, no further testing was to be conducted.||37.2|14.9|< 0.0001
72431114|NCT00783718|144374164|SUPERIORITY_OR_OTHER||Risk Difference (RD)|29.1|||<|0.0001|TWO_SIDED|95.0|17.9|40.4||P-value is based on the CMH chi-square test, with 3 stratification factors: concomitant use of oral corticosteroids; previous exposure to TNFα antagonists or concomitant immunomodulator use; enrollment in Cohort 1 or 2 in the Induction Phase.|Cochran-Mantel-Haenszel|||The Hochberg method was applied to control the overall Type I error rate at a 5% significance level. If both P-values were ≤ 0.05, both dose regimens were to be declared significant. If 1 of the P-values for the 2 dose comparisons was \> 0.05, the other P-value was to be tested at the 0.025 level and declared significant only if the P-value was ≤ 0.025. If neither dose was declared significant for the primary endpoint, no further testing was to be conducted.||40.4|17.9|< 0.0001
72431115|NCT00783718|144374165|SUPERIORITY_OR_OTHER||Risk Difference (RD)|11.5||||0.0009|TWO_SIDED|95.0|4.7|18.3||P-value is based on the CMH chi-square test, with stratification according to: 1) concomitant use of oral corticosteroids (yes/no); and 2) previous exposure to TNFα antagonists or concomitant immunomodulator use (yes/no).|Cochran-Mantel-Haenszel|||To maintain the overall Type I error rate at 5%, the key secondary assessments were performed sequentially (closed sequential method). The first secondary endpoint was to be tested only if the primary comparison was significant and the second key secondary endpoint was to be tested only if the first secondary endpoint was significant for vedolizumab.||18.3|4.7|0.0009
72363842|NCT05024032|144239339|SUPERIORITY||LS Mean Difference|-5.6|||<|0.001|TWO_SIDED|95.0|-6.4|-4.8|||Mixed Models Analysis|||||-4.8|-6.4|<0.001
72363843|NCT05024032|144239340|SUPERIORITY||LS Mean Difference|-0.37|||<|0.001|TWO_SIDED|95.0|-0.46|-0.28|||Mixed Models Analysis|||||-0.28|-0.46|<0.001
72363844|NCT05024032|144239340|OTHER||LS Mean Difference|-0.39|||<|0.001|TWO_SIDED|95.0|-0.48|-0.29|||Mixed Models Analysis|||||-0.29|-0.48|<0.001
72431116|NCT00783718|144374166|SUPERIORITY_OR_OTHER||Risk Difference (RD)|16.1||||0.0012||95.0|6.4|25.9||P-value is based on the CMH chi-square test, with stratification according to: 1) concomitant use of oral corticosteroids (yes/no); and 2) previous exposure to TNFα antagonists or concomitant immunomodulator use (yes/no).|Cochran-Mantel-Haenszel|||To maintain the overall Type I error rate at 5%, the key secondary assessments were performed sequentially (closed sequential method). The first secondary endpoint was to be tested only if the primary comparison was significant and the second key secondary endpoint was to be tested only if the first secondary endpoint was significant for vedolizumab.||25.9|6.4|0.0012
72431117|NCT00783718|144374167|SUPERIORITY_OR_OTHER||Risk Difference (RD)|32.8|||<|0.0001|TWO_SIDED|95.0|20.8|44.7||P-value is based on the CMH chi-square test, with 3 stratification factors: concomitant use of oral corticosteroids; previous exposure to TNFα antagonists or concomitant immunomodulator use; enrollment in Cohort 1 or 2 in the Induction Phase.|Cochran-Mantel-Haenszel|||To maintain the overall Type I error rate at 5% for the 2 dose regimen comparisons for each key secondary endpoint, the Hochberg method was used as described for the primary outcome measure. To further maintain the overall Type I error rate at 5%, the key secondary endpoints were also performed sequentially. The first was tested only if 1 or both of the primary comparisons were significant and the next endpoint was tested only if the previous endpoint was significant for at least 1 dose.||44.7|20.8|< 0.0001
72431118|NCT00783718|144374167|SUPERIORITY_OR_OTHER||Risk Difference (RD)|28.5|||<|0.0001|TWO_SIDED|95.0|16.7|40.3||P-value is based on the CMH chi-square test, with 3 stratification factors: concomitant use of oral corticosteroids; previous exposure to TNFα antagonists or concomitant immunomodulator use; enrollment in Cohort 1 or 2 in the Induction Phase.|Cochran-Mantel-Haenszel|||To maintain the overall Type I error rate at 5% for the 2 dose regimen comparisons for each key secondary endpoint, the Hochberg method was used as described for the primary outcome measure. To further maintain the overall Type I error rate at 5%, the key secondary endpoints were also performed sequentially. The first was tested only if 1 or both of the primary comparisons were significant and the next endpoint was tested only if the previous endpoint was significant for at least 1 dose.||40.3|16.7|< 0.0001
72431119|NCT00783718|144374168|SUPERIORITY_OR_OTHER||Risk Difference (RD)|32.0|||<|0.0001|TWO_SIDED|95.0|20.3|43.8||P-value is based on the CMH chi-square test, with 3 stratification factors: concomitant use of oral corticosteroids; previous exposure to TNFα antagonists or concomitant immunomodulator use; enrollment in Cohort 1 or 2 in the Induction Phase.|Cochran-Mantel-Haenszel|||To maintain the overall Type I error rate at 5% for the 2 dose regimen comparisons for each key secondary endpoint, the Hochberg method was used as described for the primary outcome measure. To further maintain the overall Type I error rate at 5%, the key secondary endpoints were also performed sequentially. The first was tested only if 1 or both of the primary comparisons were significant and the next endpoint was tested only if the previous endpoint was significant for at least 1 dose.||43.8|20.3|< 0.0001
72431120|NCT00783718|144374168|SUPERIORITY_OR_OTHER||Risk Difference (RD)|36.3|||<|0.0001|TWO_SIDED|95.0|24.4|48.3||P-value is based on the CMH chi-square test, with 3 stratification factors: concomitant use of oral corticosteroids; previous exposure to TNFα antagonists or concomitant immunomodulator use; enrollment in Cohort 1 or 2 in the Induction Phase.|Cochran-Mantel-Haenszel|||To maintain the overall Type I error rate at 5% for the 2 dose regimen comparisons for each key secondary endpoint, the Hochberg method was used as described for the primary outcome measure. To further maintain the overall Type I error rate at 5%, the key secondary endpoints were also performed sequentially. The first was tested only if 1 or both of the primary comparisons were significant and the next endpoint was tested only if the previous endpoint was significant for at least 1 dose.||48.3|24.4|< 0.0001
72431121|NCT00783718|144374169|SUPERIORITY_OR_OTHER||Risk Difference (RD)|11.8||||0.0079|TWO_SIDED|95.0|3.1|20.5||P-value is based on the CMH chi-square test, with 3 stratification factors: concomitant use of oral corticosteroids; previous exposure to TNFα antagonists or concomitant immunomodulator use; enrollment in Cohort 1 or 2 in the Induction Phase.|Cochran-Mantel-Haenszel|||To maintain the overall Type I error rate at 5% for the 2 dose regimen comparisons for each key secondary endpoint, the Hochberg method was used as described for the primary outcome measure. To further maintain the overall Type I error rate at 5%, the key secondary endpoints were also performed sequentially. The first was tested only if 1 or both of the primary comparisons were significant and the next endpoint was tested only if the previous endpoint was significant for at least 1 dose.||20.5|3.1|0.0079
72431122|NCT00783718|144374169|SUPERIORITY_OR_OTHER||Risk Difference (RD)|15.3||||0.0009|TWO_SIDED|95.0|6.2|24.4||P-value is based on the CMH chi-square test, with 3 stratification factors: concomitant use of oral corticosteroids; previous exposure to TNFα antagonists or concomitant immunomodulator use; enrollment in Cohort 1 or 2 in the Induction Phase.|Cochran-Mantel-Haenszel|||To maintain the overall Type I error rate at 5% for the 2 dose regimen comparisons for each key secondary endpoint, the Hochberg method was used as described for the primary outcome measure. To further maintain the overall Type I error rate at 5%, the key secondary endpoints were also performed sequentially. The first was tested only if 1 or both of the primary comparisons were significant and the next endpoint was tested only if the previous endpoint was significant for at least 1 dose.||24.4|6.2|0.0009
72431123|NCT00783718|144374170|SUPERIORITY_OR_OTHER||Risk Difference (RD)|17.6||||0.012|TWO_SIDED|95.0|3.9|31.3||P-value based on the CMH chi-square test, with 3 stratification factors: concomitant use of oral corticosteroids; previous exposure to TNFα antagonists or concomitant immunomodulator use; enrollment in Cohort 1 or 2 in the Induction Phase.|Cochran-Mantel-Haenszel|||To maintain the overall Type I error rate at 5% for the 2 dose regimen comparisons for each key secondary endpoint, the Hochberg method was used as described for the primary outcome measure. To further maintain the overall Type I error rate at 5%, the key secondary endpoints were also performed sequentially. The first was tested only if 1 or both of the primary comparisons were significant and the next endpoint was tested only if the previous endpoint was significant for at least 1 dose.||31.3|3.9|0.0120
72431124|NCT00783718|144374170|SUPERIORITY_OR_OTHER||Risk Difference (RD)|31.4|||<|0.0001|TWO_SIDED|95.0|16.6|46.2||P-value is based on the CMH chi-square test, with 3 stratification factors: concomitant use of oral corticosteroids; previous exposure to TNFα antagonists or concomitant immunomodulator use; enrollment in Cohort 1 or 2 in the Induction Phase.|Cochran-Mantel-Haenszel|||To maintain the overall Type I error rate at 5% for the 2 dose regimen comparisons for each key secondary endpoint, the Hochberg method was used as described for the primary outcome measure. To further maintain the overall Type I error rate at 5%, the key secondary endpoints were also performed sequentially. The first was tested only if 1 or both of the primary comparisons were significant and the next endpoint was tested only if the previous endpoint was significant for at least 1 dose.||46.2|16.6|< 0.0001
72431125|NCT01027871|144374173|SUPERIORITY_OR_OTHER||Least Squares Mean Difference (Final)|0.17||||0.433|TWO_SIDED|90.0|-0.18|0.52||The statistical significance level is 0.10.|Mixed Models Analysis||The Least Squares Mean Difference = LY Combined - Insulin Glargine; and 90% confidence interval (CI) = 90% CI of the least squares mean difference.|||0.52|-0.18|0.433
72431126|NCT01027871|144374174|SUPERIORITY_OR_OTHER||Least Squares Mean Difference (Final)|-0.2||||0.388|TWO_SIDED|90.0|-0.59|0.19||The statistical significance level is 0.10.|Mixed Models Analysis||The Least Squares Mean Difference = LY Combined - Insulin Glargine; and 90% confidence interval (CI) = 90% CI of the least squares mean difference.|||0.19|-0.59|0.388
72431127|NCT01027871|144374175|SUPERIORITY_OR_OTHER||Least Squares Mean Difference (Final)|-0.09||||0.197|TWO_SIDED|90.0|-0.21|0.03||The statistical significance level is 0.10.|Mixed Models Analysis||The Least Squares Mean Difference = LY Combined - Insulin Glargine; and 90% confidence interval (CI) = 90% CI of the least squares mean difference.|||0.03|-0.21|0.197
72431128|NCT01027871|144374176|SUPERIORITY_OR_OTHER|||||||0.609||95.0||||"The statistical significance level is 0.10.~P-value is for HbA1c \<7.0%"|Fisher Exact|||||||0.609
72431129|NCT01027871|144374176|SUPERIORITY_OR_OTHER|||||||0.314||95.0||||"The statistical significance level is 0.10.~P-value is for HbA1c ≤6.5%"|Fisher Exact|||||||0.314
72431130|NCT01027871|144374177|SUPERIORITY_OR_OTHER|||||||0.375||95.0||||"The statistical significance level is 0.10.~P-value is for HbA1c \<7.0%."|Fisher Exact|||||||0.375
72431131|NCT01027871|144374177|SUPERIORITY_OR_OTHER|||||||0.811||95.0||||"The statistical significance level is 0.10.~P- value is for HbA1c ≤6.5%"|Fisher Exact|||||||0.811
72431132|NCT01027871|144374178|SUPERIORITY_OR_OTHER||Least Squares Mean Difference (Final)|-0.43||||0.144|TWO_SIDED|90.0|-0.92|0.05||"The statistical significance level is 0.10.~P- value is for morning 2-hr postprandial BG"|Mixed Models Analysis||The Least Squares Mean Difference = LY Combined - Insulin Glargine; and 90% confidence interval (CI) = 90% CI of the least squares mean difference.|||0.05|-0.92|0.144
72431133|NCT01027871|144374178|SUPERIORITY_OR_OTHER||Least Squares Mean Difference (Final)|-0.25||||0.36|TWO_SIDED|90.0|-0.7|0.2||"The statistical significance level is 0.10.~P-value is for midday pre-meal BG."|Mixed Models Analysis||The Least Squares Mean Difference = LY Combined - Insulin Glargine; and 90% confidence interval (CI) = 90% CI of the least squares mean difference.|||0.20|-0.70|0.360
72431134|NCT01027871|144374178|SUPERIORITY_OR_OTHER||Least Squares Mean Difference (Final)|-0.26||||0.342|TWO_SIDED|90.0|-0.72|0.19||"The statistical significance level is 0.10.~P-value is for midday 2-hr postprandial BG."|Mixed Models Analysis||The Least Squares Mean Difference = LY Combined - Insulin Glargine; and 90% confidence interval (CI) = 90% CI of the least squares mean difference.|||0.19|-0.72|0.342
72431135|NCT01027871|144374178|SUPERIORITY_OR_OTHER||Least Squares Mean Difference (Final)|-0.12||||0.654|TWO_SIDED|90.0|-0.56|0.32||"The statistical significance level is 0.10.~P-value is for evening pre-meal BG"|Mixed Models Analysis||The Least Squares Mean Difference = LY Combined - Insulin Glargine; and 90% confidence interval (CI) = 90% CI of the least squares mean difference.|||0.32|-0.56|0.654
72431136|NCT01027871|144374178|SUPERIORITY_OR_OTHER||Least Squares Mean Difference (Final)|-0.25||||0.387|TWO_SIDED|90.0|-0.73|0.23||"The statistical significance level is 0.10.~P-value is for evening 2-hr postprandial BG."|Mixed Models Analysis||The Least Squares Mean Difference = LY Combined - Insulin Glargine; and 90% confidence interval (CI) = 90% CI of the least squares mean difference.|||0.23|-0.73|0.387
72431137|NCT01027871|144374178|SUPERIORITY_OR_OTHER||Least Squares Mean Difference (Final)|-0.29||||0.339|TWO_SIDED|90.0|-0.79|0.21||"The statistical significance level is 0.10.~P-value is for bed time BG."|Mixed Models Analysis||The Least Squares Mean Difference = LY Combined - Insulin Glargine; and 90% confidence interval (CI) = 90% CI of the least squares mean difference.|||0.21|-0.79|0.339
72431138|NCT01027871|144374178|SUPERIORITY_OR_OTHER||Least Squares Mean Difference (Final)|0.1||||0.676|TWO_SIDED|90.0|-0.3|0.5||"The statistical significance level is 0.10.~P-value is for 0300 hours BG."|Mixed Models Analysis||The Least Squares Mean Difference = LY Combined - Insulin Glargine; and 90% confidence interval (CI) = 90% CI of the least squares mean difference.|||0.50|-0.30|0.676
72431139|NCT01027871|144374180|SUPERIORITY_OR_OTHER|||||||0.162||95.0||||The statistical significance level is 0.10.|Fisher Exact|||||||0.162
72431140|NCT01027871|144374181|SUPERIORITY_OR_OTHER|||||||0.804||95.0||||The statistical significance level is 0.10.|Negative Binomial Model|||||||0.804
72431141|NCT01027871|144374183|SUPERIORITY_OR_OTHER||Least Squares Mean Difference (Final)|-0.01||||0.937||90.0|-0.16|0.14||"The statistical significance level is 0.10.~P-value is for baseline."|ANOVA||The Least Squares Mean Difference = LY Combined - Insulin Glargine; and 90% confidence interval (CI) = 90% CI of the least squares mean difference.|||0.14|-0.16|0.937
72431142|NCT01027871|144374183|SUPERIORITY_OR_OTHER||Least Squares Mean Difference (Final)|-0.03||||0.687|TWO_SIDED|90.0|-0.16|0.1||"The statistical significance level is 0.10.~P-value is for Week 12."|Mixed Models Analysis||The Least Squares Mean Difference = LY Combined - Insulin Glargine; and 90% confidence interval (CI) = 90% CI of the least squares mean difference.|||0.10|-0.16|0.687
72431143|NCT01027871|144374185|SUPERIORITY_OR_OTHER||Least Squares Mean Difference (Final)|-0.4||||0.159|TWO_SIDED|90.0|-0.87|0.07||The statistical significance level is 0.10 with no adjustments for multiple comparisons.|Mixed Models Analysis||The Least Squares Mean Difference = LY2605541 Algorithm 1 - Insulin Glargine; and 90% confidence interval (CI) = 90% CI of the least squares mean difference.|||0.07|-0.87|0.159
72431144|NCT01027871|144374185|SUPERIORITY_OR_OTHER||Least Squares Mean Difference (Final)|-0.17||||0.542|TWO_SIDED|90.0|-0.62|0.29||The statistical significance level is 0.10 with no adjustments for multiple comparisons.|Mixed Models Analysis||The Least Squares Mean Difference = LY2605541 Algorithm 2 - Insulin Glargine; and 90% confidence interval (CI) = 90% CI of the least squares mean difference.|||0.29|-0.62|0.542
72431145|NCT01027871|144374186|SUPERIORITY_OR_OTHER||Least Squares Mean Difference (Final)|-0.01||||0.88|TWO_SIDED|90.0|-0.16|0.13||The statistical significance level is 0.10 with no adjustments for multiple comparisons.|Mixed Models Analysis||The Least Squares Mean Difference = LY2605541 Algorithm 1 - Insulin Glargine; and 90% confidence interval (CI) = 90% CI of the least squares mean difference.|||0.13|-0.16|0.880
72431146|NCT01027871|144374186|SUPERIORITY_OR_OTHER||Least Squares Mean Difference (Final)|-0.17||||0.045|TWO_SIDED|90.0|-0.32|-0.03||The statistical significance level is 0.10 with no adjustments for multiple comparisons.|Mixed Models Analysis||The Least Squares Mean Difference = LY2605541 Algorithm 2 - Insulin Glargine; and 90% confidence interval (CI) = 90% CI of the least squares mean difference.|||-0.03|-0.32|0.045
72431147|NCT01027871|144374187|SUPERIORITY_OR_OTHER|||||||0.273||95.0||||"The statistical significance level is 0.10 with no adjustments for multiple comparisons.~P-value is for HbA1c \<7.0%."|Fisher Exact|||||||0.273
72431148|NCT01027871|144374187|SUPERIORITY_OR_OTHER|||||||0.287||95.0||||"The statistical significance level is 0.10 with no adjustments for multiple comparisons.~P-value is for HbA1c ≤6.5%."|Fisher Exact|||||||0.287
72431149|NCT01027871|144374187|SUPERIORITY_OR_OTHER|||||||0.879||95.0||||"The statistical significance level is 0.10 with no adjustments for multiple comparisons.~P-value is for HbA1c \<7.0%."|Fisher Exact|||||||0.879
72431150|NCT01027871|144374187|SUPERIORITY_OR_OTHER|||||||0.722||95.0||||"The statistical significance level is 0.10 with no adjustments for multiple comparisons.~P-value is for HbA1c ≤6.5%."|Fisher Exact|||||||0.722
72431151|NCT01027871|144374188|SUPERIORITY_OR_OTHER|||||||0.139||95.0||||"The statistical significance level is 0.10 with no adjustments for multiple comparisons.~P-value is for HbA1c \<7.0%."|Fisher Exact|||||||0.139
72431152|NCT01027871|144374188|SUPERIORITY_OR_OTHER|||||||0.569||95.0||||"The statistical significance level is 0.10 with no adjustments for multiple comparisons.~P-value is for HbA1c ≤6.5%."|Fisher Exact|||||||0.569
72431153|NCT01027871|144374188|SUPERIORITY_OR_OTHER|||||||0.515||95.0||||"The statistical significance level is 0.10 with no adjustments for multiple comparisons.~P-value is for HbA1c \<7.0%."|Fisher Exact|||||||0.515
72431154|NCT01027871|144374188|SUPERIORITY_OR_OTHER|||||||1||95.0||||"The statistical significance level is 0.10 with no adjustments for multiple comparisons.~P-value is for HbA1c ≤6.5%."|Fisher Exact|||||||1.000
72431155|NCT01027871|144374189|SUPERIORITY_OR_OTHER||Least Squares Mean Difference (Final)|0.26||||0.305|TWO_SIDED|90.0|-0.16|0.67||"The statistical significance level is 0.10 with no adjustments for multiple comparisons.~P-value is for morning pre-meal BG."|Mixed Models Analysis||The Least Squares Mean Difference = LY2605541 Algorithm 1 - Insulin Glargine; and 90% confidence interval (CI) = 90% CI of the least squares mean difference.|||0.67|-0.16|0.305
72431156|NCT01027871|144374189|SUPERIORITY_OR_OTHER||Least Squares Mean Difference (Final)|-0.14||||0.571|TWO_SIDED|90.0|-0.54|0.26||"The statistical significance level is 0.10 with no adjustments for multiple comparisons.~P-value is for morning pre-meal BG."|Mixed Models Analysis||The Least Squares Mean Difference = LY2605541 Algorithm 2 - Insulin Glargine; and 90% confidence interval (CI) = 90% CI of the least squares mean difference.|||0.26|-0.54|0.571
72431157|NCT01027871|144374189|SUPERIORITY_OR_OTHER||Least Squares Mean Difference (Final)|-0.26||||0.454||90.0|-0.85|0.32||"The statistical significance level is 0.10 with no adjustments for multiple comparisons.~P-value is for morning 2-hr postprandial BG."|Mixed Models Analysis||The Least Squares Mean Difference = LY2605541 Algorithm 1 - Insulin Glargine; and 90% confidence interval (CI) = 90% CI of the least squares mean difference.|||0.32|-0.85|0.454
72431158|NCT01027871|144374189|SUPERIORITY_OR_OTHER||Least Squares Mean Difference (Final)|-0.83||||0.016|TWO_SIDED|90.0|-1.4|-0.26||"The statistical significance level is 0.10 with no adjustments for multiple comparisons.~P-value is for morning 2-hr postprandial BG."|Mixed Models Analysis||The Least Squares Mean Difference = LY2605541 Algorithm 2 - Insulin Glargine; and 90% confidence interval (CI) = 90% CI of the least squares mean difference.|||-0.26|-1.40|0.016
72431159|NCT01027871|144374189|SUPERIORITY_OR_OTHER||Least Squares Mean Difference (Final)|-0.07||||0.838||90.0|-0.61|0.48||"The statistical significance level is 0.10 with no adjustments for multiple comparisons.~P-value is for midday pre-meal BG."|Mixed Models Analysis||The Least Squares Mean Difference = LY2605541 Algorithm 1 - Insulin Glargine; and 90% confidence interval (CI) = 90% CI of the least squares mean difference.|||0.48|-0.61|0.838
72431160|NCT01027871|144374189|SUPERIORITY_OR_OTHER||Least Squares Mean Difference (Final)|-0.69||||0.033|TWO_SIDED|90.0|-1.22|-0.16||"The statistical significance level is 0.10 with no adjustments for multiple comparisons.~P-value is for midday pre-meal BG."|Mixed Models Analysis||The Least Squares Mean Difference = LY2605541 Algorithm 2 - Insulin Glargine; and 90% confidence interval (CI) = 90% CI of the least squares mean difference.|||-0.16|-1.22|0.033
72431161|NCT01027871|144374189|SUPERIORITY_OR_OTHER||Least Squares Mean Difference (Final)|-0.4||||0.229|TWO_SIDED|90.0|-0.95|0.15||"The statistical significance level is 0.10 with no adjustments for multiple comparisons.~P-value is for midday 2-hr postprandial BG."|Mixed Models Analysis||The Least Squares Mean Difference = LY2605541 Algorithm 1 - Insulin Glargine; and 90% confidence interval (CI) = 90% CI of the least squares mean difference.|||0.15|-0.95|0.229
72431162|NCT01027871|144374189|SUPERIORITY_OR_OTHER||Least Squares Mean Difference (Final)|-0.27||||0.412|TWO_SIDED|90.0|-0.8|0.27||"The statistical significance level is 0.10 with no adjustments for multiple comparisons.~P-value is for midday 2-hr postprandial BG."|Mixed Models Analysis||The Least Squares Mean Difference = LY2605541 Algorithm 2 - Insulin Glargine; and 90% confidence interval (CI) = 90% CI of the least squares mean difference.|||0.27|-0.80|0.412
72431163|NCT01027871|144374189|SUPERIORITY_OR_OTHER||Least Squares Mean Difference (Final)|-0.15||||0.642|TWO_SIDED|90.0|-0.68|0.38||"The statistical significance level is 0.10 with no adjustments for multiple comparisons.~P-value is for evening pre-meal BG."|Mixed Models Analysis||The Least Squares Mean Difference = LY2605541 Algorithm 1 - Insulin Glargine; and 90% confidence interval (CI) = 90% CI of the least squares mean difference.|||0.38|-0.68|0.642
72431164|NCT01027871|144374189|SUPERIORITY_OR_OTHER||Least Squares Mean Difference (Final)|-0.16||||0.614|TWO_SIDED|90.0|-0.67|0.36||"The statistical significance level is 0.10 with no adjustments for multiple comparisons.~P-value is for evening pre-meal BG."|Mixed Models Analysis||The Least Squares Mean Difference = LY2605541 Algorithm 2 - Insulin Glargine; and 90% confidence interval (CI) = 90% CI of the least squares mean difference.|||0.36|-0.67|0.614
72431165|NCT01027871|144374189|SUPERIORITY_OR_OTHER||Least Squares Mean Difference (Final)|-0.5||||0.147|TWO_SIDED|90.0|-1.07|0.07||"The statistical significance level is 0.10 with no adjustments for multiple comparisons.~P-value is for evening 2-hr postprandial BG."|Mixed Models Analysis||The Least Squares Mean Difference = LY2605541 Algorithm 1 - Insulin Glargine; and 90% confidence interval (CI) = 90% CI of the least squares mean difference.|||0.07|-1.07|0.147
72431166|NCT01027871|144374189|SUPERIORITY_OR_OTHER||Least Squares Mean Difference (Final)|-0.42||||0.21|TWO_SIDED|90.0|-0.98|0.13||"The statistical significance level is 0.10 with no adjustments for multiple comparisons.~P-value is for evening 2-hr postprandial BG."|Mixed Models Analysis||The Least Squares Mean Difference = LY2605541 Algorithm 2 - Insulin Glargine; and 90% confidence interval (CI) = 90% CI of the least squares mean difference.|||0.13|-0.98|0.210
72431167|NCT01027871|144374189|SUPERIORITY_OR_OTHER||Least Squares Mean Difference (Final)|-0.28||||0.438|TWO_SIDED|90.0|-0.86|0.31||"The statistical significance level is 0.10 with no adjustments for multiple comparisons.~P-value is for bed time BG."|Mixed Models Analysis||The Least Squares Mean Difference = LY2605541 Algorithm 1 - Insulin Glargine; and 90% confidence interval (CI) = 90% CI of the least squares mean difference.|||0.31|-0.86|0.438
72431168|NCT01027871|144374189|SUPERIORITY_OR_OTHER||Least Squares Mean Difference (Final)|-0.7||||0.043|TWO_SIDED|90.0|-1.28|-0.13||"The statistical significance level is 0.10 with no adjustments for multiple comparisons.~P-value is for bed time BG."|Mixed Models Analysis||The Least Squares Mean Difference = LY2605541 Algorithm 2 - Insulin Glargine; and 90% confidence interval (CI) = 90% CI of the least squares mean difference.|||-0.13|-1.28|0.043
72431169|NCT01027871|144374189|SUPERIORITY_OR_OTHER||Least Squares Mean Difference (Final)|0.24||||0.403|TWO_SIDED|90.0|-0.23|0.72||"The statistical significance level is 0.10 with no adjustments for multiple comparisons.~P-value is for 0300 hours BG."|Mixed Models Analysis||The Least Squares Mean Difference = LY2605541 Algorithm 1 - Insulin Glargine; and 90% confidence interval (CI) = 90% CI of the least squares mean difference.|||0.72|-0.23|0.403
72363845|NCT05024032|144239341|SUPERIORITY||LS Mean Difference|-0.46|||<|0.001|TWO_SIDED|95.0|-0.61|-0.32|||Mixed Models Analysis|||||-0.32|-0.61|<0.001
72363846|NCT05024032|144239341|SUPERIORITY||LS Mean Difference|-0.54|||<|0.001|TWO_SIDED|95.0|-0.69|-0.4|||Mixed Models Analysis|||||-0.40|-0.69|<0.001
72363847|NCT05024032|144239342|SUPERIORITY||LS Mean Difference|1.2||||0.044|TWO_SIDED|95.0|0.0|2.3|||ANCOVA|||||2.3|0.0|0.044
72363848|NCT05024032|144239342|SUPERIORITY||LS Mean Difference|1.2||||0.05|TWO_SIDED|95.0|0.0|2.3|||ANCOVA|||||2.3|0.0|0.050
72363849|NCT05024032|144239343|SUPERIORITY||LS Mean Difference|7.8|||<|0.001|TWO_SIDED|95.0|3.7|11.8|||ANCOVA|||||11.8|3.7|<0.001
72363850|NCT05024032|144239343|SUPERIORITY||LS Mean Difference|8.5|||<|0.001|TWO_SIDED|95.0|4.4|12.7|||ANCOVA|||||12.7|4.4|<0.001
72363851|NCT05024032|144239344|SUPERIORITY||LS Mean Difference|-4.8|||<|0.001|TWO_SIDED|95.0|-6.9|-2.7|||Mixed Models Analysis|||||-2.7|-6.9|<0.001
72363852|NCT05024032|144239345|SUPERIORITY||LS Mean Difference|-6.1|||<|0.001|TWO_SIDED|95.0|-9.1|-3.1|||Mixed Models Analysis|||||-3.1|-9.1|<0.001
72363853|NCT05024032|144239346|SUPERIORITY||LS Mean Difference|-0.31|||||TWO_SIDED|95.0|-0.51|-0.11||||||||-0.11|-0.51|
72363854|NCT05024032|144239347|SUPERIORITY||LS Mean Difference|0.09|||||TWO_SIDED|95.0|0.03|0.14||||||||0.14|0.03|
72363855|NCT05024032|144239348|SUPERIORITY||LS Mean Difference|-0.06|||||TWO_SIDED|95.0|-0.25|0.13||||||||0.13|-0.25|
72363856|NCT05024032|144239349|SUPERIORITY||LS Mean Difference|-0.25|||||TWO_SIDED|95.0|-0.34|-0.16||||||||-0.16|-0.34|
72363857|NCT05024032|144239350|SUPERIORITY||LS Mean Difference|-0.58|||||TWO_SIDED|95.0|-0.79|-0.37||||||||-0.37|-0.79|
72363858|NCT05024032|144239351|SUPERIORITY||LS Mean Difference|-0.07|||||TWO_SIDED|95.0|-0.12|-0.01||||||||-0.01|-0.12|
72363859|NCT05024032|144239352|SUPERIORITY||LS Mean Difference|-6.3|||||TWO_SIDED|95.0|-8.6|-4.0||||||||-4.0|-8.6|
72363860|NCT03591406|144239361|NON_INFERIORITY|Pre-defined non-inferiority margin of -15%|Difference in proportions|1.12|||||TWO_SIDED|95.0|-2.15|4.71|||||2-sided 95% Confidence Interval (CI) was computed using the Wilson score method with continuity correction described by Newcombe.|||4.71|-2.15|
72363861|NCT02066181|144239373|SUPERIORITY||Hazard Ratio (HR)|11.3|||<|0.001|ONE_SIDED|95.0|5.7||||Log Rank||||||5.7|<0.001
72363862|NCT02851615|144239409|SUPERIORITY|Power analyses were calculated on the PAM-13, our primary outcome measure. Analyses were conducted using the internal Monte Carlo simulation capabilities of Mplus (Version 1.20). Based on the effect size obtained from published pilot data, we expected the change in baseline/posttreatment Behavioral Activation for the SCThrive intervention group to be n2 = .14 (large effect). Based on these assumptions, the desired sample size was 54 participants (N = 27 per group) to achieve power of .80.|Mean Difference (Net)|7.75|STANDARD_ERROR_OF_MEAN|13.14||0.09|TWO_SIDED|95.0|-1.27|19.22||The threshold for statistical significance was p =.05|ANCOVA|||We conducted separate mixed ANOVA analyses to assess for the effects of group (SCThrive/SCHealthEd), time (baseline/post-treatment), and group x time interaction for the PAM-13.||19.22|-1.27|.09
72363863|NCT02851615|144239410|SUPERIORITY||Mean Difference (Net)|0.15|STANDARD_ERROR_OF_MEAN|0.55||0.28|TWO_SIDED|95.0|-0.19|0.66||The threshold for significance was p =.05|ANCOVA|||We conducted separate mixed ANOVA analyses to assess for the effects of group (SCThrive/SCHealthEd), time (baseline/post-treatment), and group x time interaction for the TRAQ-5||.66|-.19|.28
72363864|NCT02851615|144239411|SUPERIORITY||Mean Difference (Net)|0.02|STANDARD_DEVIATION|0.13||0.27|TWO_SIDED|95.0|-0.018|0.06||The threshold for statistical significance was p =.05|t-test, 2 sided|||We conducted a paired-samples t-test to assess for the effects of time (baseline/post-treatment) for participants (n=16) in the SCThrive intervention arm for the UNC TRxANSITION Scale.||.06|-.018|.27
72363865|NCT05764785|144239413|SUPERIORITY|||||||0.182||||||Assumption of Sphericity was violated and Greenhouse-Geisser was above .75, thus Huynh-Feldt correction was used.|Mixed ANOVA|||||||.182
72363866|NCT05764785|144239414|SUPERIORITY|||||||0.461||||||Assumption of Sphericity was violated and Greenhouse-Geisser was above .75, thus Huynh-Feldt correction was used.|Mixed ANOVA|||||||.461
72363867|NCT05764785|144239415|SUPERIORITY|||||||0.228||||||Assumption of Sphericity was violated and Greenhouse-Geisser was above .75, thus Huynh-Feldt correction was used.|Mixed ANOVA|||||||.228
72363868|NCT05764785|144239416|SUPERIORITY|||||||0.295||||||Assumption of Sphericity was violated and Greenhouse-Geisser was above .75, thus Huynh-Feldt correction was used.|Mixed ANOVA|||||||.295
72363869|NCT05764785|144239417|SUPERIORITY|||||||0.915||||||Assumption of Sphericity was violated and Greenhouse-Geisser was above .75, thus Huynh-Feldt correction was used.|Mixed ANOVA|||||||.915
72363870|NCT05764785|144239418|SUPERIORITY|||||||0.226||||||Assumption of Sphericity was violated and Greenhouse-Geisser was above .75, thus Huynh-Feldt correction was used.|Mixed ANOVA|||||||.226
72363871|NCT02670811|144239435|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05||||||The primary outcome, systolic blood pressure (mmHg), between groups was analyzed using an independent sample student t test.|t-test, 2 sided|||||||<0.05
72363872|NCT02670811|144239435|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05||||||The primary outcome, systolic blood pressure (mmHg), was analyzed using a paired student t test.|t-test, 2 sided|||||||<0.05
72363873|NCT02670811|144239436|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05||||||The secondary outcome, diastolic blood pressure (mmHg), between groups was analyzed using an independent sample student t test.|t-test, 2 sided|||||||<0.05
72363874|NCT02670811|144239437|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05||||||The secondary outcome, total cholesterol (mg/dL), between groups was analyzed using an independent sample student t test.|t-test, 2 sided|||||||<0.05
72431170|NCT01027871|144374189|SUPERIORITY_OR_OTHER||Least Squares Mean Difference (Final)|-0.29||||0.314|TWO_SIDED|90.0|-0.75|0.18||"The statistical significance level is 0.10 with no adjustments for multiple comparisons.~P-value is for 0300 hours BG."|Mixed Models Analysis||The Least Squares Mean Difference = LY2605541 Algorithm 2 - Insulin Glargine; and 90% confidence interval (CI) = 90% CI of the least squares mean difference.|||0.18|-0.75|0.314
72431171|NCT01027871|144374191|SUPERIORITY_OR_OTHER|||||||0.046||95.0||||The statistical significance level is 0.10 with no adjustments for multiple comparisons.|Fisher Exact|||||||0.046
72431172|NCT01027871|144374191|SUPERIORITY_OR_OTHER|||||||0.224||95.0||||The statistical significance level is 0.10 with no adjustments for multiple comparisons.|Fisher Exact|||||||0.224
72431173|NCT01027871|144374192|SUPERIORITY_OR_OTHER|||||||0.561||95.0||||The statistical significance level is 0.10 with no adjustments for multiple comparisons.|Negative Binomial Model|||||||0.561
72431174|NCT01027871|144374192|SUPERIORITY_OR_OTHER|||||||0.518||95.0||||The statistical significance level is 0.10 with no adjustments for multiple comparisons.|Negative Binomial Model|||||||0.518
72431175|NCT01027871|144374193|SUPERIORITY_OR_OTHER||Least Squares Mean Difference (Final)|-0.01||||0.938|TWO_SIDED|90.0|-0.2|0.18||"The statistical significance level is 0.10 with no adjustments for multiple comparisons.~P-value is for baseline."|ANOVA||The Least Squares Mean Difference = LY2605541 Algorithm 1 - Insulin Glargine; and 90% confidence interval (CI) = 90% CI of the least squares mean difference.|||0.18|-0.20|0.938
72431176|NCT01027871|144374193|SUPERIORITY_OR_OTHER||Least Squares Mean Difference (Final)|0.0||||0.972|TWO_SIDED|90.0|-0.18|0.19||"The statistical significance level is 0.10 with no adjustments for multiple comparisons.~P-value is for baseline."|ANOVA||The Least Squares Mean Difference = LY2605541 Algorithm 2 - Insulin Glargine; and 90% confidence interval (CI) = 90% CI of the least squares mean difference.|||0.19|-0.18|0.972
72431177|NCT01027871|144374193|SUPERIORITY_OR_OTHER||Least Squares Mean Difference (Final)|-0.01||||0.927|TWO_SIDED|90.0|-0.16|0.15||"The statistical significance level is 0.10 with no adjustments for multiple comparisons.~P-value is for Week 12."|Mixed Models Analysis||The Least Squares Mean Difference = LY2605541 Algorithm 1 - Insulin Glargine; and 90% confidence interval (CI) = 90% CI of the least squares mean difference.|||0.15|-0.16|0.927
72431178|NCT01027871|144374193|SUPERIORITY_OR_OTHER||Least Squares Mean Difference (Final)|-0.1||||0.293|TWO_SIDED|90.0|-0.25|0.05||"The statistical significance level is 0.10 with no adjustments for multiple comparisons.~P-value is for Week 12."|Mixed Models Analysis||The Least Squares Mean Difference = LY2605541 Algorithm 2 - Insulin Glargine; and 90% confidence interval (CI) = 90% CI of the least squares mean difference.|||0.05|-0.25|0.293
72431179|NCT04996069|144374240|SUPERIORITY|No power calculation performed.||||||0.45||||||p value threshold is .05|t-test, 2 sided|||||||.45
72431180|NCT04060680|144374243|SUPERIORITY|The pre-specified Objective Performance Criterion (OPC) for the major complication free rate at 6 months is 0.79. If the lower confidence bound of two-sided 95% confidence interval for the freedom from the first major EV ICD System/procedure-related complication through 182 days post implant exceeds 0.79, the primary safety objective will be met. The freedom from the first major EV ICD System/procedure-related complication was estimated using the Kaplan-Meier method.|Major complication-free rate|92.6|||<|0.0001|TWO_SIDED|95.0|89.0|95.0||A priori threshold for statistical significance is 0.025|Kaplan-Meier method|||The primary safety objective is to demonstrate the freedom from major complications related to the EV ICD System and/or procedure at 6 months post-implant exceeds an OPC of 79%. H0: p ≤ 0.79 HA: p \> 0.79, where p denotes the 6-month (182 days) freedom from major EV ICD System/procedure-related complications rate.||95.0|89.0|<0.0001
72431181|NCT04060680|144374244|SUPERIORITY|The pre-specified OPC for the EV ICD defibrillation testing success at implant is 0.88. If the lower confidence bound of two-sided 95% confidence interval for the proportion of EV ICD patients achieving defibrillation testing success at implant exceeds 0.88, the primary efficacy objective will be met. The primary efficacy objective will be evaluated using a one-proportion binomial exact test along with a two-sided 95% Clopper-Pearson confidence bound.|Proportion|98.7|||<|0.0001|TWO_SIDED|95.0|96.6|99.6||A priori threshold for statistical significance is 0.025|One-proportion binomial exact test|||The primary efficacy is to demonstrate the EV ICD defibrillation testing success rate at implant is greater than an OPC of 88%. H0: p ≤ 0.88 HA: p \> 0.88, where p denotes the probability of EV ICD defibrillation success at implant.||99.6|96.6|<0.0001
72431182|NCT00935792|144374246|OTHER||||||||||||||||||Estimated maximum tolerated dose was 2.5mg of oral everolimus thrice weekly for 9 weeks and alemtuzumab subcutaneously thrice weekly for 8 weeks.|||
72431183|NCT02322775|144374252|SUPERIORITY_OR_OTHER||Difference of Least Square Means|0.08||||0.04|TWO_SIDED|95.0|0.0|0.15||Hypothesis testing were reported using 2-sided 5% level tests with nominal p-values (i.e., not adjusted for multiplicity).|Mixed Models Analysis|||The null hypothesis was: H0: Change from baseline in pre-bronchodilator FEV1 (L) at Week 12 (benralizumab vs placebo)=0.||0.15|0|0.040
72431184|NCT02322775|144374253|SUPERIORITY_OR_OTHER||Difference of Least Square Means|8.84||||0.233|TWO_SIDED|95.0|-5.74|23.42||Hypothesis testing were reported using 2-sided 5% level tests with nominal p-values (i.e., not adjusted for multiplicity).|Mixed Models Analysis|||||23.42|-5.74|0.233
72431185|NCT02322775|144374254|SUPERIORITY_OR_OTHER||Difference of Least Square Means|5.29||||0.456|TWO_SIDED|95.0|-8.67|19.25||Hypothesis testing were reported using 2-sided 5% level tests with nominal p-values (i.e., not adjusted for multiplicity).|Mixed Models Analysis|||||19.25|-8.67|0.456
72431186|NCT02322775|144374255|SUPERIORITY_OR_OTHER||Difference of Least Square Means|-0.13||||0.266|TWO_SIDED|95.0|-0.35|0.1||Hypothesis testing were reported using 2-sided 5% level tests with nominal p-values (i.e., not adjusted for multiplicity).|Mixed Models Analysis|||||0.10|-0.35|0.266
72431187|NCT02322775|144374256|SUPERIORITY_OR_OTHER||Difference of Least Square Means|-0.36||||0.2|TWO_SIDED|95.0|-0.91|0.19||Hypothesis testing were reported using 2-sided 5% level tests with nominal p-values (i.e., not adjusted for multiplicity).|Mixed Models Analysis|||||0.19|-0.91|0.200
72431188|NCT02322775|144374257|SUPERIORITY_OR_OTHER||Difference of Least Square Means|-0.03||||0.38|TWO_SIDED|95.0|-0.08|0.03||Hypothesis testing were reported using 2-sided 5% level tests with nominal p-values (i.e., not adjusted for multiplicity).|Mixed Models Analysis|||||0.03|-0.08|0.380
72431189|NCT02322775|144374258|SUPERIORITY_OR_OTHER||Difference of Least Square Means|-0.17||||0.114|TWO_SIDED|95.0|-0.39|0.04||Hypothesis testing were reported using 2-sided 5% level tests with nominal p-values (i.e., not adjusted for multiplicity).|Mixed Models Analysis|||||0.04|-0.39|0.114
72431190|NCT02322775|144374260|SUPERIORITY_OR_OTHER||Difference of Least Square Means|0.21||||0.055|TWO_SIDED|95.0|0.0|0.42||Hypothesis testing were reported using 2-sided 5% level tests with nominal p-values (i.e., not adjusted for multiplicity).|ANCOVA|||Parameter: Total score||0.42|0|0.055
72431191|NCT02322775|144374260|SUPERIORITY_OR_OTHER||Difference of Least Square Means|0.23||||0.063|TWO_SIDED|95.0|-0.01|0.47||Hypothesis testing were reported using 2-sided 5% level tests with nominal p-values (i.e., not adjusted for multiplicity).|ANCOVA|||Parameter: Symptoms score||0.47|-0.01|0.063
72431192|NCT02322775|144374260|SUPERIORITY_OR_OTHER||Difference of Least Square Means|0.2||||0.061|TWO_SIDED|95.0|-0.01|0.41||Hypothesis testing were reported using 2-sided 5% level tests with nominal p-values (i.e., not adjusted for multiplicity).|ANCOVA|||Parameter: Activity limitation score||0.41|-0.01|0.061
72431193|NCT02322775|144374260|SUPERIORITY_OR_OTHER||Difference of Least Square Means|0.19||||0.156|TWO_SIDED|95.0|-0.07|0.45||Hypothesis testing were reported using 2-sided 5% level tests with nominal p-values (i.e., not adjusted for multiplicity).|ANCOVA|||Parameter: Emotional function score||0.45|-0.07|0.156
72431194|NCT02322775|144374260|SUPERIORITY_OR_OTHER||Difference of Least Square Means|0.19||||0.135|TWO_SIDED|95.0|-0.06|0.44||Hypothesis testing were reported using 2-sided 5% level tests with nominal p-values (i.e., not adjusted for multiplicity).|ANCOVA|||Parameter: Environmental stimuli score||0.44|-0.06|0.135
72431195|NCT00615433|144374263|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0|||||Mixed Models Analysis|||Improvements in PANSS ratings are estimated from 2 prior studies of lurasidone. Assuming lurasidone differs from placebo in change from baseline in PANSS by 6.8 and 10.0 for 40 and 120 mg, respectively, and assuming a standard deviation of 19.1, then n=120 subjects per group provides approximately 97% power (at α=0.05, two-sided) to reject the null hypothesis of no difference from placebo for at least 1 dose. This calculation uses Bonferroni's procedure for controlling pairwise differences.||||<0.05
72431196|NCT00615433|144374264|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Mixed Models Analysis|||||||<0.05
72431197|NCT04739423|144374265|OTHER||Least Squares Mean|5.4822||||0.0479|TWO_SIDED|95.0|0.0575|10.9069|||Mixed Models Analysis|||Between treatment analysis for Accuracy for happiness - change from baseline to Day 14.||10.9069|0.0575|0.0479
72431198|NCT04739423|144374265|OTHER||Least Squares Mean|4.7954||||0.0161|TWO_SIDED|95.0|0.9843|8.6064|||Mixed Models Analysis|||Between treatment analysis for Accuracy for sadness - Change from baseline to Day 14||8.6064|0.9843|0.0161
72431199|NCT04739423|144374265|OTHER||Least Squares Mean|167.29||||0.0237|TWO_SIDED|95.0|25.36|309.23|||Mixed Models Analysis|||Between treatment analysis of Reaction time for anger - change from baseline to Day 7||309.23|25.36|0.0237
72431200|NCT04739423|144374265|OTHER||Least Squares Mean|-1.2761||||0.7188|TWO_SIDED|95.0|-9.2424|6.6902|||Mixed Models Analysis|||Between treatment analysis for Accuracy for happiness - change from baseline to Day 14||6.6902|-9.2424|0.7188
72431201|NCT04739423|144374265|OTHER||Least Squares Mean|1.8955||||0.5478|TWO_SIDED|95.0|-4.9026|8.6935|||Mixed Models Analysis|||Between treatment analysis for Accuracy for sadness - Change from baseline to Day 14||8.6935|-4.9026|0.5478
72363875|NCT02670811|144239438|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05||||||The secondary outcome, low density lipoprotein (mg/dL), between groups was analyzed using an independent sample student t test.|t-test, 2 sided|||||||<0.05
72431202|NCT04739423|144374265|OTHER||Least Squares Mean|-7.52||||0.951|TWO_SIDED|95.0|-291.21|276.17|||Mixed Models Analysis|||Between treatment analysis of Reaction time for anger - change from baseline to Day 7||276.17|-291.21|0.9510
72431203|NCT04739423|144374267|OTHER||Least Squares Mean|0.68||||0.0737|TWO_SIDED|95.0|-0.066|1.432|||Mixed Models Analysis|||Between treatment analysis for Immediate Word Recall: number of words - Change from Baseline to Day 1, 4 hours post-dose||1.432|-0.066|0.0737
72431204|NCT04739423|144374267|OTHER||Least Squares Mean|1.12||||0.0033|TWO_SIDED|95.0|0.382|1.868|||Mixed Models Analysis|||Between treatment analysis for Immediate Word Recall: number of words - Change from Baseline to Day 14, 4 hours post-dose||1.868|0.382|0.0033
72431205|NCT04739423|144374267|OTHER||Least Squares Mean|1.72||||0.0029|TWO_SIDED|95.0|0.6|2.84|||Mixed Models Analysis|||Between treatment comparison for Delayed Word Recall: number of words - Change from Baseline to Day 1, 4 hours post-dose||2.840|0.600|0.0029
72431206|NCT04739423|144374267|OTHER||Least Squares Mean|1.29||||0.0247|TWO_SIDED|95.0|0.168|2.418|||Mixed Models Analysis|||Between treatment analysis for Delayed Word Recall: number of words - Change from Baseline to Day 7, 4 hours post-dose||2.418|0.168|0.0247
72431207|NCT04739423|144374267|OTHER||Least Squares Mean|1.69||||0.0016|TWO_SIDED|95.0|0.653|2.732|||Mixed Models Analysis|||Between treatment analysis for Delayed Word Recognition: number of words - Change from Baseline to Day 7, 4 hours post-dose||2.732|0.653|0.0016
72431208|NCT04739423|144374267|OTHER||Least Squares Mean|-0.06||||0.9126|TWO_SIDED|95.0|-1.127|1.009|||Mixed Models Analysis|||Between treatment analysis for Immediate Word recall: number of words - Change from Baseline to Day 1, 4 hours post-dose||1.009|-1.127|0.9126
72431209|NCT04739423|144374267|OTHER||Least Squares Mean|-0.24||||0.657|TWO_SIDED|95.0|-1.317|0.837|||Mixed Models Analysis|||Between treatment analysis for Immediate Word Recall: number of words - Change from Baseline to Day 14, 4 hours post-dose||0.837|-1.317|0.6570
72431210|NCT04739423|144374267|OTHER||Least Squares Mean|-0.06||||0.9458|TWO_SIDED|95.0|-1.787|1.669|||Mixed Models Analysis|||Between treatment comparison for Delayed Word Recall: number of words - Change from Baseline to Day 1, 4 hours post-dose||1.669|-1.787|0.9458
72431211|NCT04739423|144374267|OTHER||Least Squares Mean|0.97||||0.2327|TWO_SIDED|95.0|-0.642|2.579|||Mixed Models Analysis|||Between treatment analysis for Delayed Word Recall: number of words - Change from Baseline to Day 7, 4 hours post-dose||2.579|-0.642|0.2327
72431212|NCT04739423|144374267|OTHER||Least Squares Mean|0.84||||0.4154|TWO_SIDED|95.0|-1.208|2.879|||Mixed Models Analysis|||Between treatment analysis for Delayed Word Recognition: number of words - Change from Baseline to day 7, 4 hours post-dose||2.879|-1.208|0.4154
72431213|NCT04739423|144374268|OTHER||Least Squares Mean|5.06|||<|0.0001|TWO_SIDED|95.0|3.956|6.16|||Mixed Models Analysis|||Between treatment analysis (active - placebo) for Sleeping Heart Rate change from baseline across periods||6.160|3.956|<0.0001
72431214|NCT04739423|144374269|OTHER||Least Squares Mean|1.0||||0.0017|TWO_SIDED|95.0|0.432|1.565|||Mixed Models Analysis|||Between treatment analysis (active - placebo) for sleeping HRV change from baseline across periods.||1.565|0.432|0.0017
72431215|NCT04739423|144374270|OTHER||Least Squares Mean|-10.22||||0.0049|TWO_SIDED|95.0|-16.867|-3.567|||Mixed Models Analysis|||Between treatment analysis (active - placebo) for sleeping HRV root mean square of successive differences change from baseline across periods||-3.567|-16.867|0.0049
72363876|NCT02670811|144239439|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05||||||The secondary outcome, high density lipoproteins (mg/dL), between groups were analyzed using an independent sample student t test.|t-test, 2 sided|||||||<0.05
72363877|NCT02670811|144239440|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05||||||The secondary outcome, triglycerides (mg/dL), between groups was analyzed using an independent sample student t test.|t-test, 2 sided|||||||<0.05
72363878|NCT03714672|144239455|SUPERIORITY||Mean Difference (Final Values)|-4.1|||<|0.0001|TWO_SIDED|95.0|-4.8|-3.4|||ANCOVA|ANCOVA model with treatment, baseline pain intensity, and site as covariates.|LS means, 95% CIs, and pairwise CIs and p-values comparing the combination treatment arm to the monotherapy arm.|Bonferroni-Holm procedure used for determining the statistical significance of the results.||-3.4|-4.8|<0.0001
72363879|NCT03714672|144239455|SUPERIORITY||Mean Difference (Final Values)|-4.5|||<|0.0001|TWO_SIDED|95.0|-5.2|-3.8|||ANCOVA|ANCOVA model with treatment, baseline pain intensity, and site as covariates.|LS means, 95% CIs, and pairwise CIs and p-values comparing the combination treatment arm to the monotherapy arm.|Bonferroni-Holm procedure used for determining the statistical significance of the results.||-3.8|-5.2|<0.0001
72363880|NCT03714672|144239455|SUPERIORITY||Mean Difference (Final Values)|-3.2|||<|0.0001|TWO_SIDED|95.0|-3.9|-2.5|||ANCOVA|ANCOVA model with treatment, baseline pain intensity, and site as covariates.|LS means, 95% CIs, and pairwise CIs and p-values comparing the combination treatment arm to the monotherapy arm.|Bonferroni-Holm procedure used for determining the statistical significance of the results. The planned test was a test for non-inferiority.||-2.5|-3.9|<0.0001
72363881|NCT03714672|144239455|SUPERIORITY||Mean Difference (Final Values)|-2.8|||<|0.0001|TWO_SIDED|95.0|-3.5|-2.1|||ANCOVA|ANCOVA model with treatment, baseline pain intensity, and site as covariates.|LS means, 95% CIs, and pairwise CIs and p-values comparing the combination treatment arm to the monotherapy arm.|Bonferroni-Holm procedure used for determining the statistical significance of the results. The planned test was a test for non-inferiority.||-2.1|-3.5|<0.0001
72363882|NCT02345070|144239465|SUPERIORITY|The hierarchical testing sequence continued only when previous endpoint was statistically significant at 0.05 level.|Least Square (LS) Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|1.05|=|0.6339|TWO_SIDED|95.0|-2.56|1.56||Threshold for significance at 0.05 level.|Mixed Models Analysis||SAR156597 200mg qw versus Placebo qw|A hierarchical testing procedure was used to control type I error. Testing was done sequentially in order the outcome measures were reported. Analyzed using Mixed Model for Repeated Measurements (MMRM) with fixed categorical effects of treatment arm, stratification factor (with/without background therapy), time point, treatment-by-time point interaction, stratification factor-by-treatment-by-time point interaction, and continuous fixed covariate of percent predicted FVC baseline.||1.56|-2.56|= 0.6339
72363883|NCT02345070|144239465|SUPERIORITY|The hierarchical testing sequence continued only when previous endpoint was statistically significant at 0.05 level.|LS Mean Difference|0.56|STANDARD_ERROR_OF_MEAN|1.04|=|0.5874|TWO_SIDED|95.0|-1.47|2.6||Threshold for significance at 0.05 level.|Mixed Models Analysis||SAR156597 200mg q2w versus Placebo qw|A hierarchical testing procedure was used to control type I error. Testing was performed sequentially in the order outcome measures were reported (q2w dose group compared to placebo). Analysis was performed using MMRM with fixed categorical effects of treatment arm, stratification factor (with/without background therapy), time point, treatment-by-time point interaction, stratification factor-by-treatment-by-time point interaction, and continuous fixed covariate of percent predicted FVC baseline.||2.6|-1.47|= 0.5874
72363884|NCT03081117|144239469|SUPERIORITY|||||||0.669|||||||Fisher Exact|||Analysis of Enrolled group.||||0.669
72363885|NCT03081117|144239470|SUPERIORITY||Mean Difference (Net)|-0.3914||||0.0366|TWO_SIDED|||||The threshold for statistical significance was p = 0.05.|t-test, 2 sided|Degrees of freedom = 14||Analysis for Intent-to-Treat group.||||0.0366
72363886|NCT03081117|144239470|SUPERIORITY||Mean Difference (Net)|-0.5146||||0.0103|TWO_SIDED|||||The threshold for statistical significance was p = 0.05.|t-test, 2 sided|Degrees of freedom = 12||Analysis for Per Protocol group.||||0.0103
72363887|NCT03081117|144239473|SUPERIORITY||||||>|0.25||||||The threshold for statistical significance was p = 0.05.|Wald test, two-sided|||Comparisons of change from W0 to W24 between treatment and placebo are based on a mixed effects regression model using a two-sided Wald test of the interaction term for treatment and time.||||>0.25
72363888|NCT03081117|144239474|SUPERIORITY||||||>|0.25|||||||Wald test, two-sided|The threshold for statistical significance was p = 0.05.||Comparisons of change from W0 to W24 between treatment and placebo are based on a mixed effects regression model using a two-sided Wald test of the interaction term for treatment and time.||||>0.25
72363889|NCT03081117|144239475|SUPERIORITY||Unstandardized beta coefficient|-0.32|STANDARD_ERROR_OF_MEAN|0.27||0.244|TWO_SIDED||||||Wald test, two-sided|||Comparisons of change from W0 to W24 between treatment and placebo are based on a mixed effects regression model using a two-sided Wald test of the interaction term for treatment and time.||||0.244
72363890|NCT03081117|144239476|SUPERIORITY||||||>|0.25||||||The threshold for statistical significance was p = 0.05.|Wald test, two-sided|||Comparisons of change from W0 to W24 between treatment and placebo are based on a mixed effects regression model using a two-sided Wald test of the interaction term for treatment and time.||||>0.25
72363891|NCT03081117|144239477|SUPERIORITY||||||>|0.25|||||||Wald test, two-sided|The threshold for statistical significance was p = 0.05.||Comparisons of change from W0 to W24 between treatment and placebo are based on a mixed effects regression model using a two-sided Wald test of the interaction term for treatment and time.||||>0.25
72363892|NCT03081117|144239478|SUPERIORITY||||||>|0.25|||||||Wald test, two-sided|The threshold for statistical significance was p = 0.05.||Comparisons of change from W0 to W24 between treatment and placebo are based on a mixed effects regression model using a two-sided Wald test of the interaction term for treatment and time.||||>0.25
72363893|NCT03081117|144239479|SUPERIORITY||Mean Difference (Net)|0.0031351||||0.366|TWO_SIDED|||||The threshold for statistical significance was p = 0.05.|t-test, 2 sided|Degrees of freedom = 13||Analysis for All Available group (participants who had both Baseline and Week 24 scans).||||0.366
72363894|NCT03081117|144239479|SUPERIORITY||Mean Difference (Net)|0.0025586||||0.505|TWO_SIDED|||||The threshold for statistical significance was p = 0.05.|t-test, 2 sided|Degrees fo freedom = 10||Analysis for Per Protocol group.||||0.505
72363895|NCT03081117|144239480|SUPERIORITY||Mean Difference (Net)|0.00000061||||0.98|TWO_SIDED|||||The threshold for statistical significance was p = 0.05.|t-test, 2 sided|Degrees of freedom = 13||Analysis for All Available group (participants who had both Baseline and Week 24 scans).||||0.98
72363896|NCT03081117|144239480|SUPERIORITY||Mean Difference (Net)|-0.0000054||||0.86|TWO_SIDED|||||The threshold for statistical significance was p = 0.05.|t-test, 2 sided|Degrees of freedom = 10||Analysis for Per Protocol group.||||0.86
72363897|NCT02584686|144239498|SUPERIORITY_OR_OTHER|||||||0.0049|||||||t-test, 1 sided|||Comparing the mean PSV before \& after treatment in the study group using the t-test.||||0.0049
72363898|NCT02584686|144239498|SUPERIORITY_OR_OTHER|||||||0.68|||||||t-test, 1 sided|||Comparing the mean PSV before \& after treatment in the control group using the t-test.||||0.68
72363899|NCT02584686|144239500|SUPERIORITY_OR_OTHER|||||||0.01086956|||||||Wilcoxon (Mann-Whitney)|||Comparing the Erection hardness score before \& after treatment in the study group.||||0.01086956
72363900|NCT02584686|144239500|SUPERIORITY_OR_OTHER|||||||0.6618176|||||||Wilcoxon (Mann-Whitney)|||Comparing the Erection hardness score before \& after treatment in the control group.||||0.6618176
72363901|NCT02584686|144239502|SUPERIORITY_OR_OTHER|||||||0.00751288|||||||Wilcoxon (Mann-Whitney)|||SHIM Score in the study group before \& after treatment.||||0.00751288
72363902|NCT02584686|144239502|SUPERIORITY_OR_OTHER|||||||0.6618176|||||||Wilcoxon (Mann-Whitney)|||SHIM Score in the control group before \& after treatment.||||0.6618176
72363903|NCT02584686|144239503|SUPERIORITY_OR_OTHER|||||||0.027191||||||"Due to the small sample size Fisher exact test was chosen. 7 out of 12 in the treatment group answered yes, while 1 out of 12 in the control group answered yes."|Fisher Exact|||||||0.027191
72363904|NCT02584686|144239505|SUPERIORITY_OR_OTHER|||||||0.109091|||||||Fisher Exact|||"Fisher Exact Test was used to compare the change in the number of in patients who answered Yes in Secondary Outcome 8 (SEP-Q2 Question Before Treatment) to patients who answered Yes in Secondary Outcome 9 (SEP-Q2 Question after Treatment), for both (BTXA) and Saline groups."||||0.109091
72363905|NCT02584686|144239507|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||"Fisher Exact Test was used to compare the change in patients who answered Yes in Secondary Outcome 10 (SEP-Q3 Question Before Treatment) to patients who answered Yes in Secondary Outcome 11 (SEP-Q3 Question after Treatment)."||||1
72363906|NCT01709721|144239508|SUPERIORITY|||||||0.147|||||||Chi-squared|Pearson's chi-square test||Superiority of intrathecal hydromorphone hydrochloride as compared to a control arm.||||0.147
72363907|NCT01709721|144239509|SUPERIORITY|||||||0.0342|||||||ANCOVA|||"P-value by ANCOVA, with randomization group as the factor and initial parameter value as covariate.~Note: For subjects with missing endpoint on Day 119, value is imputed using the Last Observation Carried Forward (LOCF).~Note: Baseline for this analysis is the Day 84 visit."||||0.0342
72363908|NCT01709721|144239510|SUPERIORITY|||||||0.1642|||||||ANCOVA|||"P-value by ANCOVA, with randomization group as the factor and initial parameter value as covariate.~Note: For subjects with missing endpoint on Day 119, value is imputed using the Last Observation Carried Forward (LOCF).~Note: Baseline for this analysis is the Day 84 visit."||||0.1642
72363909|NCT01709721|144239511|SUPERIORITY|||||||0.016|||||||ANCOVA|ANCOVA, with randomization group as the factor and initial parameter value as covariate.||"P-value by ANCOVA, with randomization group as the factor and initial parameter value as covariate.~Note: For subjects with missing endpoint on Day 119, value is imputed using the Last Observation Carried Forward (LOCF).~Note: Baseline for this analysis is the Day 84 visit."||||0.0160
72363910|NCT01709721|144239512|SUPERIORITY|||||||0.0007|||||||ANCOVA|ANCOVA, with randomization group as the factor and initial parameter value as covariate.||"P-value by ANCOVA, with randomization group as the factor and initial parameter value as covariate.~Note: For subjects with missing endpoint on Day 119, value is imputed using the Last Observation Carried Forward (LOCF).~Note: Baseline for this analysis is the Day 84 visit."||||0.0007
72363911|NCT01709721|144239513|SUPERIORITY|||||||0.0088||||||ANCOVA, with randomization group as the factor and initial parameter value as covariate.|ANCOVA|||"P-value by ANCOVA, with randomization group as the factor and initial parameter value as covariate.~Note: For subjects with missing endpoint on Day 119, value is imputed using the Last Observation Carried Forward (LOCF).~Note: Baseline for this analysis is the Day 84 visit."||||0.0088
72363912|NCT01709721|144239514|SUPERIORITY|||||||0.011||||||Log-rank test for Kaplan-Meier Estimate of Time to Rescue (days).|Log Rank|||||||0.011
72363913|NCT01709721|144239515|SUPERIORITY|||||||0.0335|||||||Cochran-Mantel-Haenszel|||P-value by the Cochran-Mantel-Haenszel mean score test (using equally spaced scores).||||0.0335
72363914|NCT01709721|144239517|SUPERIORITY|Pearson's chi-square test||||||0.01||||||Pearson's chi-square test|Chi-squared|||||||0.010
72363915|NCT00423579|144239518|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-14.5||||0||95.0|-18.9|-10.1|||Student's t test for independent data||Difference in percentage change in mean LDL-C values (change from baseline to week 6) between the two treatment groups. (Ezetimibe \[EZ\]/Simvastatin \[S\] \[10/20mg\] + S \[placebo\] group minus the EZ/S \[10mg/placebo\] + S \[40mg\] group)|||-10.1|-18.9|0.0000
72363916|NCT02392637|144239519|SUPERIORITY|||||||0.62|||||||Log Rank|||||||0.62
72363917|NCT02392637|144239520|SUPERIORITY|||||||0.39|||||||Log Rank|||||||0.39
72363918|NCT00106704|144239522|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.74|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-90.0|-0.57|||ANCOVA|Model terms: treatment, stratum (on metformin or not), baseline A1C||||-0.57|-90.0|<0.001
72363919|NCT00106704|144239523|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-20.1|STANDARD_ERROR_OF_MEAN|4.2|<|0.001|TWO_SIDED|95.0|-28.4|-11.8|||ANCOVA|Model terms: treatment, stratum (on metformin or not at Visit 3), baseline A1C||||-11.8|-28.4|<0.001
72363920|NCT03773978|144239532|SUPERIORITY||Hazard Ratio (HR)|0.241|||<|0.001|TWO_SIDED|95.0|0.128|0.453|||Log Rank|||||0.453|0.128|<0.001
72363921|NCT03773978|144239533|SUPERIORITY||Odds Ratio (OR)|2.72||||0.052|TWO_SIDED|95.0|0.99|7.46|||Regression, Logistic|||at week 16||7.46|0.99|0.052
72363922|NCT03773978|144239533|SUPERIORITY||Odds Ratio (OR)|3.64||||0.002|TWO_SIDED|95.0|1.6|8.28|||Regression, Logistic|||at week 20||8.28|1.60|0.002
72363923|NCT03773978|144239533|SUPERIORITY||Odds Ratio (OR)|4.34|||<|0.001|TWO_SIDED|95.0|2.0|9.41|||Regression, Logistic|||at week 24||9.41|2.00|<0.001
72363924|NCT03773978|144239533|SUPERIORITY||Odds Ratio (OR)|3.37||||0.001|TWO_SIDED|95.0|1.62|7.01|||Regression, Logistic|||at week 28||7.01|1.62|0.001
72363925|NCT03773978|144239533|SUPERIORITY||Odds Ratio (OR)|3.0||||0.002|TWO_SIDED|95.0|1.48|6.07|||Regression, Logistic|||at week 32||6.07|1.48|0.002
72363926|NCT03773978|144239533|SUPERIORITY||Odds Ratio (OR)|3.25|||<|0.001|TWO_SIDED|95.0|1.62|6.52|||Regression, Logistic|||at week 36||6.52|1.62|<0.001
72431216|NCT02507219|144374302|SUPERIORITY||Slope|0.000055||||0.512|TWO_SIDED|95.0|-0.00011|0.00022|||Mixed Models Analysis||Slope is percent signal change per milligram of ibuprofen.|A linear mixed effects model was run for the left amygdala with contrast and percent signal change between faces and shapes as the dependent variable and ibuprofen dose as a continuous predictor. Each subject had up to 3 visits and each visit contained 3 contrasts (happy - shape, angry - shape, fearful - shape) so subject and drug were used as random effects. Drug was nested inside of subject.||0.00022|-0.00011|0.512
72431217|NCT02507219|144374302|SUPERIORITY||Slope|-0.00012||||0.221|TWO_SIDED|95.0|-0.0003|0.000067|||Mixed Models Analysis||Slope is the percent signal change per mg of ibuprofen.|A linear mixed effects model was run for the right amygdala with contrast and percent signal change between faces and shapes as the dependent variable and ibuprofen dose as a continuous predictor. Each subject had up to 3 visits and each visit contained 3 contrasts (happy - shape, angry - shape, fearful - shape) so subject and drug were used as random effects. Drug was nested inside of subject.||0.000067|-0.00030|0.221
72431218|NCT05174065|144374303|SUPERIORITY||Adjusted Difference in Proportion|32.6|||<|0.0001|TWO_SIDED|95.0|18.7|46.5|||Cochran-Mantel-Haenszel|Adjusted for the stratification factors of rounded PPPASI total score range (≤ 20/21 to 30/≥ 31) and focal infection status (yes/no) at baseline.|Based on the Cochran-Mantel-Haenszel method adjusting for the stratification factors. The adjusted difference in proportion was the weighted average of the treatment differences across strata.|||46.5|18.7|<0.0001
72431219|NCT05174065|144374304|SUPERIORITY||Difference in Least Squares Mean|-6.13|||<|0.0001|TWO_SIDED|95.0|-8.57|-3.69|||MMRM|With treatment group, visit time, treatment-by-time interaction, and stratification factors as fixed effect, and the baseline value as a covariate.|Apremilast - Placebo|||-3.69|-8.57|<0.0001
72431220|NCT05174065|144374305|SUPERIORITY||Difference in Least Squares Mean|-1.5|||<|0.0001|TWO_SIDED|95.0|-2.2|-0.9|||MMRM|With treatment group, visit time, treatment-by-time interaction, and stratification factors as fixed effect, and baseline value as covariate.|Apremilast - Placebo|||-0.9|-2.2|<0.0001
72431221|NCT05174065|144374306|SUPERIORITY||Difference in Least Squares Mean|-7.8||||0.033|TWO_SIDED|95.0|-14.9|-0.6|||MMRM|With treatment group, visit time, treatment-by-time interaction, and stratification factors as fixed effect, and the baseline value as a covariate.|Apremilast - Placebo|||-0.6|-14.9|0.0330
72431222|NCT05174065|144374307|SUPERIORITY||Difference in Least Squares Mean|-10.8||||0.0076|TWO_SIDED|95.0|-18.6|-2.9|||MMRM|With treatment group, visit time, treatment-by-time interaction, and stratification factors as fixed effect, and the baseline value as a covariate.|Apremilast - Placebo|||-2.9|-18.6|0.0076
72431223|NCT05174065|144374308|SUPERIORITY||Difference in Least Squares Mean|-1.4||||0.0036|TWO_SIDED|95.0|-2.4|-0.5|||MMRM|With treatment group, visit time, treatment-by-time interaction, and stratification factors as fixed effect, and the baseline value as a covariate.|Apremilast - Placebo|||-0.5|-2.4|0.0036
72431224|NCT02337361|144374495|OTHER||||||||||||||||||Generalized estimating equations (GEE)(Diggle et al. 2002) tested e-SBI efficacy, controlling for demographic differences between study condition and study sites. GEE models estimate population average or marginal models and account for within-subject nonindependence (clustering) of observations across multiple waves of data collection and use all available data in model estimation.|||
72431225|NCT02337361|144374495|OTHER||||||||||||||||||Generalized estimating equations tested e-SBI efficacy, controlling for demographic differences between study condition and study sites. GEE models estimate population average or marginal models and account for within-subject nonindependence (clustering) of observations across multiple waves of data collection and use all available data in model estimation|||
72431226|NCT02337361|144374496|OTHER||Odds Ratio (OR)|0.22|STANDARD_ERROR_OF_MEAN|0.12|<|0.01|TWO_SIDED||||||t-test, 2 sided||the e-SBI group was at reduced odds relative to the control group to report weekly or more frequent drinking at 6 month follow-up||Generalized estimating equations (GEE) tested e-SBI efficacy, controlling for demographic differences between study condition and study sites. GEE models estimate population average or marginal models and account for within-subject nonindependence (clustering) of observations across multiple waves of data collection and use all available data in model estimation.|||<.01
72431227|NCT02337361|144374497|OTHER||Odds Ratio (OR)|0.23|STANDARD_ERROR_OF_MEAN|0.14|<|0.05|TWO_SIDED||||||t-test, 2 sided||the e-SBI group was at reduced odds relative to the control group to report drinking a maximum quantity of 5 or more drinks in a day at 6 month follow-up|||||<.05
72431228|NCT02337361|144374498|OTHER||Odds Ratio (OR)|0.51|STANDARD_ERROR_OF_MEAN|0.2|<|0.1|TWO_SIDED||||||t-test, 2 sided||the e-SBI group was at reduced odds relative to the control group to report any tobacco use at 6 month follow-up||Generalized estimating equations (GEE) tested e-SBI efficacy, controlling for demographic differences between study condition and study sites. GEE models estimate population average or marginal models and account for within-subject nonindependence (clustering) of observations across multiple waves of data collection and use all available data in model estimation.|||<.10
72431229|NCT02337361|144374499|OTHER||Odds Ratio (OR)|0.26|STANDARD_ERROR_OF_MEAN|0.15|<|0.01|TWO_SIDED||||||t-test, 2 sided||the e-SBI group was at reduced odds relative to the control group to report significant depression at 6 month follow-up|||||<.01
72431230|NCT02337361|144374500|OTHER||||||||||||||||||Generalized estimating equations (GEE) tested DrinkWise's effects on changes in depression over time controlling for demographic differences between study condition and study sites.|||
72431231|NCT02427646|144374513|OTHER|"A linear mixed effects (LME) model via the maximized likelihood estimation was implemented using open-source statistical software, R (version 3.3.3). The effects of each clinical and kinematic outcome measures were examined for each participant group (ET and PD arms were separately analyzed thus no interaction effects were investigated) in separate LME models (lme4 package using lmer function)."|||||<|0.05|||||||Linear mixed effects model|||||||<0.05
72431232|NCT02427646|144374514|OTHER|"A linear mixed effects (LME) model via the maximized likelihood estimation was implemented using open-source statistical software, R (version 3.3.3). The effects of each clinical and kinematic outcome measures were examined for each participant group (ET and PD arms were separately analyzed thus no interaction effects were investigated) in separate LME models (lme4 package using lmer function)."|||||<|0.05|||||||Linear mixed effects model|a log-transformation ofthe RMS datasets was applied for statistical analysis||||||<0.05
72431233|NCT00901485|144374525|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|To test for non-inferiority, a sample size of 36 (18 patients completing both arms of the crossover) was calculated to provide 80% power to detect a 2.5% drop in the primary outcome, mean overnight oxygen saturation (SpO2), with a SD of 3% at a significance level of 0.05|Median Difference (Final Values)|0.4||||0.13|TWO_SIDED|95.0|-0.2|1.0||a priori threshold for significance p\<0.05|Wilcoxon (Mann-Whitney)|||"We tested the hypothesis that iVAPS can ventilate a patient naive to NIV at least as effectively as standard PS.~Sleep and breathing parameters at the end of each treatment period were compared using Wilcoxon Signed Rank test. The median difference between treatments with 95% confidence intervals was then compared by related-samples Hodges-Lehman test"||1.0|-0.2|0.13
72431234|NCT00901485|144374526|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|PtcCO2 is compared as a secondary outcome resulting in CO2 elimination similar to that of standard PS ventilation (median difference (95% CI) of -0.04(- 0.03 to 0.4)kPa in mean overnight PtcCO2).|Median Difference (Final Values)|0.0||||0.54|TWO_SIDED|95.0|-0.3|0.4|||Wilcoxon (Mann-Whitney)|||Hypothesis: that we tested the hypothesis that iVAPS, with automated selection of ventilator settings, was non-inferior to standard pressure support (PS) ventilation, with settings determined by an experienced healthcare professional, for controlling nocturnal hypoventilation in patients naïve to NIV.||0.4|-0.3|0.54
72431235|NCT00901485|144374527|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|This is a secondary outcome|Median Difference (Net)|0.0||||0.94|TWO_SIDED|95.0|-0.5|0.5|||Wilcoxon (Mann-Whitney)|||||0.5|-0.5|0.94
72431236|NCT00901485|144374528|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|This is a secondary outcome|Median Difference (Net)|-1.0||||0.42|TWO_SIDED|95.0|-2.0|1.0|||Wilcoxon (Mann-Whitney)|||||1|-2|0.42
72431237|NCT00901485|144374529|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|This is a secondary outcome|Median Difference (Net)|0.0||||0.82||95.0|-8.0|4.0|||Wilcoxon (Mann-Whitney)|||||4|-8|0.82
72431238|NCT00901485|144374530|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|This is a secondary outcome|Median Difference (Net)|1.04||||0.0004|TWO_SIDED|95.0|0.27|1.44|||Wilcoxon (Mann-Whitney)|||||1.44|0.27|0.0004
72431239|NCT00901485|144374531|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|This is a secondary outcome|Mean Difference (Net)|-0.2||||0.5|TWO_SIDED|95.0|-1.2|0.5|||Wilcoxon (Mann-Whitney)|||||0.5|-1.2|0.5
72431240|NCT00901485|144374532|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|This is a secondary outcome|Median Difference (Net)|-2.2||||0.001|TWO_SIDED|95.0|-4.5|0.3|||Wilcoxon (Mann-Whitney)|||||0.3|-4.5|0.001
72431241|NCT00901485|144374533|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|This is a secondary outcome|Median Difference (Net)|-10.0||||0.47|TWO_SIDED|95.0|-54.0|23.0|||Wilcoxon (Mann-Whitney)|||||23|-54|0.47
72431242|NCT00901485|144374534|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|This is a secondary outcome|Median Difference (Net)|0.3||||0.41|TWO_SIDED|95.0|-0.7|2.2|||Wilcoxon (Mann-Whitney)|||||2.2|-0.7|0.41
72431243|NCT00901485|144374535|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|This is a secondary outcome|Median Difference (Net)|4.0||||0.36|TWO_SIDED|95.0|-5.0|12.0|||Wilcoxon (Mann-Whitney)|||||12|-5|0.36
72431244|NCT00901485|144374536|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|This is a secondary outcome|Median Difference (Net)|2.0||||0.59|TWO_SIDED|95.0|-5.0|14.0|||Wilcoxon (Mann-Whitney)|||||14|-5|0.59
72431245|NCT00901485|144374537|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|This is a secondary outcome|Median Difference (Net)|2.0||||0.59|TWO_SIDED|95.0|-5.0|14.0|||Wilcoxon (Mann-Whitney)|||||14|-5|0.59
72431246|NCT00901485|144374538|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|This is a secondary outcome|Median Difference (Net)|-1.0||||0.72|TWO_SIDED|95.0|-9.0|5.0|||Wilcoxon (Mann-Whitney)|||||5|-9|0.72
72431247|NCT01796665|144374542|EQUIVALENCE|provides 85% power of success|Equivalence ratio|96.57|||||TWO_SIDED|90.0|92.5|105.2|||Fieller's method|||||105.2|92.5|
72431248|NCT01796665|144374543|EQUIVALENCE|provides 85% power of success|Equivalence ratio|99.96|||||TWO_SIDED|90.0|92.9|110.5|||Fieller's method|||||110.5|92.9|
72431249|NCT01796665|144374544|EQUIVALENCE|provides 85% power of success|Equivalence ratio|-1.14|||||TWO_SIDED|90.0|-13.23|-1.13|||Fieller's method|||||-1.13|-13.23|
72431250|NCT03660943|144374568|SUPERIORITY||Mean Difference (Final Values)|-2.07|STANDARD_ERROR_OF_MEAN|1.192||0.0833|TWO_SIDED|95.0|-4.42|0.27|||Mixed Models Analysis|||The MMRM analysis included the change from study baseline in scores as the dependent variable, with terms for treatment, pooled study center, study baseline K-L grade category for the index knee, study baseline BMI category, study baseline OA type (unilateral or bilateral knee OA), sex, study visit, treatment by visit interaction, and study baseline score as covariates, using an unstructured covariance structure.||0.27|-4.42|0.0833
72431251|NCT03660943|144374569|SUPERIORITY|The number of NPRS subjects differed from the WOMAC outcomes because of differences in missing data.|Mean Difference (Final Values)|-0.42|STANDARD_ERROR_OF_MEAN|0.251||0.0935|TWO_SIDED|95.0|-0.91|0.07|||Mixed Models Analysis|||The MMRM analysis included the change from study baseline in scores as the dependent variable, with terms for treatment, pooled study center, study baseline K-L grade category for the index knee, study baseline BMI category, study baseline OA type (unilateral or bilateral knee OA), sex, study visit, treatment by visit interaction, and study baseline score as covariates, using an unstructured covariance structure.||0.07|-0.91|0.0935
72431252|NCT03660943|144374570|SUPERIORITY||Mean Difference (Final Values)|-1.22|STANDARD_ERROR_OF_MEAN|0.506||0.0163|TWO_SIDED|95.0|-2.22|-0.23|||Mixed Models Analysis|||The MMRM analysis included the change from study baseline in scores as the dependent variable, with terms for treatment, pooled study center, study baseline K-L grade category for the index knee, study baseline BMI category, study baseline OA type (unilateral or bilateral knee OA), sex, study visit, treatment by visit interaction, and study baseline score as covariates, using an unstructured covariance structure.||-0.23|-2.22|0.0163
72431253|NCT03660943|144374571|SUPERIORITY||Mean Difference (Final Values)|-7.99|STANDARD_ERROR_OF_MEAN|4.076||0.0509|TWO_SIDED|95.0|-16.01|0.03|||Mixed Models Analysis|||The MMRM analysis included the change from study baseline in scores as the dependent variable, with terms for treatment, pooled study center, study baseline K-L grade category for the index knee, study baseline BMI category, study baseline OA type (unilateral or bilateral knee OA), sex, study visit, treatment by visit interaction, and study baseline score as covariates, using an unstructured covariance structure.||0.03|-16.01|0.0509
72431254|NCT00231179|144374572|NON_INFERIORITY_OR_EQUIVALENCE|Sample sizes were established when the trial was first developed. For all power calculations, we set alpha = .05 and beta = .20 and specified 2-tailed tests.|Mean Difference (Final Values)|0.81|STANDARD_DEVIATION|15.0||0.59|TWO_SIDED|95.0|0.31|2.13||Bonferroni corrections were made for multiple comparisons.|t-test, 2 sided|||We compared scores for verbal, performance, and full scale Intelligence Quotient (IQ).||2.13|0.31|0.59
72431255|NCT00231179|144374573|NON_INFERIORITY_OR_EQUIVALENCE|Please see earlier power calculation.|Hazard Ratio (HR)|10.0|STANDARD_ERROR_OF_MEAN|5.0||0.72|TWO_SIDED|95.0|||||Chi-squared|||||||0.72
72431256|NCT00231179|144374574|NON_INFERIORITY_OR_EQUIVALENCE|See previous.|Hazard Ratio (HR)|10.0|STANDARD_ERROR_OF_MEAN|5.0|<|0.01|TWO_SIDED|95.0|||||Chi-squared|||||||<0.01
72431257|NCT00231179|144374575|NON_INFERIORITY_OR_EQUIVALENCE|See previous.|Hazard Ratio (HR)|3.0|STANDARD_ERROR_OF_MEAN|3.0|<|0.05|TWO_SIDED|95.0|||||Chi-squared|||||||<0.05
72431258|NCT00231179|144374576|NON_INFERIORITY_OR_EQUIVALENCE|See previous.|Hazard Ratio (HR)|3.0|STANDARD_ERROR_OF_MEAN|3.0||0.64|TWO_SIDED|95.0|||||Chi-squared|||||||0.64
72431259|NCT02892409|144374658|EQUIVALENCE|LS Mean Ratio (TAK-438/Lansoprazole), 95 percent (%) confidence interval (CI) of the ratio were obtained by taking the anti-log of the difference or confidence limits of difference between the LS means of test and reference on the natural logarithmic scale.|Least Square (LS) Mean Ratio|105.1|||||TWO_SIDED|95.0|66.051|167.183||||||||167.183|66.051|
72431260|NCT02892409|144374659|EQUIVALENCE|LS Mean Ratio (TAK-438/Lansoprazole), 95% CI of the ratio were obtained by taking the anti-log of the difference or confidence limits of difference between the LS means of test and reference on the natural logarithmic scale.|LS Mean Ratio|93.6|||||TWO_SIDED|95.0|67.137|130.569||||||||130.569|67.137|
72431261|NCT02331940|144374661|SUPERIORITY_OR_OTHER|||||||0.88||||||p\<0.05 was considered statistically significant|t-test, 1 sided|||||||0.88
72431262|NCT01345292|144374668|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.44|STANDARD_ERROR_OF_MEAN|1.556|<|0.001|TWO_SIDED|95.0|8.37|14.5||If Sensodyne is better than Crest Regular (p\<0.05), testing would proceed to comparison of Wk 2 Mean Tactile Sensitivity Scores between Sensodyne and Crest Regular. Family-wise error was controlled at 0.05.|ANCOVA|Terms included treatment and baseline mean tactile sensitivity (Yeaple probe) score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||14.50|8.37|<0.001
72431263|NCT01345292|144374668|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.33|STANDARD_ERROR_OF_MEAN|1.566|<|0.001|TWO_SIDED|95.0|5.24|11.42||If Potassium Oxalate Mouth Rinse is better than Crest Regular (p\<0.05), testing would proceed to comparison of Wk 2 Mean Tactile Sensitivity Scores between Potassium Oxalate Mouth Rinse and Crest Regular. Family-wise error was controlled at 0.05.|ANCOVA|Terms included treatment and baseline mean tactile sensitivity (Yeaple probe) score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||11.42|5.24|<0.001
72431264|NCT01345292|144374669|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.05|STANDARD_ERROR_OF_MEAN|0.812|<|0.001|TWO_SIDED|95.0|1.45|4.65||The significance threshold level was 0.05 (two-sided). Family-wise error was controlled at 0.05.|ANCOVA|Terms included treatment and baseline mean tactile sensitivity (Yeaple probe) score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||4.65|1.45|<0.001
72431265|NCT01345292|144374669|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.41|STANDARD_ERROR_OF_MEAN|0.818||0.004|TWO_SIDED|95.0|0.8|4.02||The significance threshold level was 0.05 (two-sided). Family-wise error was controlled at 0.05.|ANCOVA|Terms included treatment and baseline mean tactile sensitivity (Yeaple probe) score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||4.02|0.80|0.004
72431266|NCT01345292|144374670|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.06|STANDARD_ERROR_OF_MEAN|2.091||0.324|TWO_SIDED|95.0|-6.19|2.06||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline mean tactile sensitivity VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||2.06|-6.19|0.324
72431267|NCT01345292|144374670|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.43|STANDARD_ERROR_OF_MEAN|2.093||0.035|TWO_SIDED|95.0|-8.56|-0.31||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline mean tactile sensitivity VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-0.31|-8.56|0.035
72431268|NCT01345292|144374671|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.55|STANDARD_ERROR_OF_MEAN|2.551|<|0.001|TWO_SIDED|95.0|-13.6|-3.52||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline mean tactile sensitivity VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-3.52|-13.6|<0.001
72431269|NCT01345292|144374671|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.2|STANDARD_ERROR_OF_MEAN|2.553|<|0.001|TWO_SIDED|95.0|-15.2|-5.13||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline mean tactile sensitivity VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-5.13|-15.2|<0.001
72431270|NCT01345292|144374672|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.91|STANDARD_ERROR_OF_MEAN|2.271||0.032|TWO_SIDED|95.0|-9.38|-0.43||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline mean cold air stimulus VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-0.43|-9.38|0.032
72431271|NCT01345292|144374672|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.42|STANDARD_ERROR_OF_MEAN|2.288||0.136|TWO_SIDED|95.0|-7.93|1.09||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline mean cold air stimulus VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||1.09|-7.93|0.136
72431272|NCT01345292|144374673|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.2|STANDARD_ERROR_OF_MEAN|2.508|<|0.001|TWO_SIDED|95.0|-16.1|-6.23||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline mean cold air stimulus VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-6.23|-16.1|<0.001
72431273|NCT01345292|144374673|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.2|STANDARD_ERROR_OF_MEAN|2.527|<|0.001|TWO_SIDED|95.0|-15.2|-5.25||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline mean cold air stimulus VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-5.25|-15.2|<0.001
72431274|NCT01345292|144374674|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.26|STANDARD_ERROR_OF_MEAN|2.012||0.533|TWO_SIDED|95.0|-5.22|2.71||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline mean global subjective VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||2.71|-5.22|0.533
72431275|NCT01345292|144374674|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.3|STANDARD_ERROR_OF_MEAN|2.023||0.522|TWO_SIDED|95.0|-5.29|2.69||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline mean global subjective VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||2.69|-5.29|0.522
72431276|NCT01345292|144374675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.53|STANDARD_ERROR_OF_MEAN|2.331|<|0.001|TWO_SIDED|95.0|-13.1|-3.94||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline mean global subjective VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-3.94|-13.1|<0.001
72431277|NCT01345292|144374675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.13|STANDARD_ERROR_OF_MEAN|2.344||0.01|TWO_SIDED|95.0|-10.8|-1.51||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline mean global subjective VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-1.51|-10.8|0.010
72431278|NCT01033643|144374691|OTHER||Accumulation or Geometric Mean Ratio|2.36|||||||||||||Accumulation ratio or geometric mean ratio (GMR) was calculated as last day of multiple dosing of MK-3614 (Day 10) divided by the first day of multiple dosing of MK-3614 (Day 1).|||||
72431279|NCT01033643|144374692|OTHER||Accumulation or Geometric Mean Ratio|1.62|||||||||||||Accumulation ratio or GMR was calculated as last day of multiple dosing of MK-3614 (Day 13) divided by the first day of multiple dosing of MK-3614 (Day 4).|||||
72431280|NCT01033643|144374694|OTHER||Accumulation or Geometric Mean Ratio|1.9|||||||||||||Accumulation ratio or GMR was calculated as last day of multiple dosing of MK-3614 (Day 10) divided by the first day of multiple dosing of MK-3614 (Day 1).|||||
72431281|NCT01033643|144374694|OTHER||Accumulation or Geometric Mean Ratio|1.63|||||||||||||Accumulation ratio or GMR was calculated as last day of multiple dosing of MK-3614 (Day 10) divided by the first day of multiple dosing of MK-3614 (Day 1).|||||
72431282|NCT01033643|144374695|OTHER||Accumulation or Geometric Mean Ratio|1.91|||||||||||||Accumulation ratio or GMR was calculated as last day of multiple dosing of MK-3614 (Day 10) divided by the first day of multiple dosing of MK-3614 (Day 1).|||||
72431283|NCT01033643|144374696|OTHER||Accumulation or Geometric Mean Ratio|1.38|||||||||||||Accumulation ratio or GMR was calculated as last day of multiple dosing of MK-3614 (Day 13) divided by the first day of multiple dosing of MK-3614 (Day 4).|||||
72431284|NCT01033643|144374703|OTHER|Linear Model|Mean Difference from Placebo|-4.17|||||TWO_SIDED|90.0|-9.53|1.2||||||||1.20|-9.53|
72431285|NCT01033643|144374703|OTHER|Linear Model|Mean Difference from Placebo|4.78|||||TWO_SIDED|90.0|-1.41|10.97||||||||10.97|-1.41|
72431286|NCT01033643|144374703|OTHER|Linear Model|Mean Difference from Placebo|-3.47|||||TWO_SIDED|90.0|-8.37|1.42||||||||1.42|-8.37|
72431287|NCT01033643|144374703|OTHER|Linear Model|Mean Difference from Placebo|3.53|||||TWO_SIDED|90.0|-1.37|8.42||||||||8.42|-1.37|
72431288|NCT01033643|144374704|OTHER|Linear Model|Mean Difference from Placebo|0.23|||||TWO_SIDED|90.0|-6.91|7.36||||||||7.36|-6.91|
72431289|NCT01033643|144374704|OTHER|Linear Model|Mean Difference from Placebo|-1.66|||||TWO_SIDED|90.0|-8.79|5.47||||||||5.47|-8.79|
72431290|NCT01033643|144374704|OTHER|Linear Model|Mean Difference from Placebo|2.11|||||TWO_SIDED|90.0|-5.02|9.25||||||||9.25|-5.02|
72431291|NCT01033643|144374704|OTHER|Linear Model|Mean Difference from Placebo|-1.23|||||TWO_SIDED|90.0|-9.41|6.94||||||||6.94|-9.41|
72431292|NCT01033643|144374705|OTHER|Linear Model|Mean Difference from Placebo|-0.75|||||TWO_SIDED|90.0|-9.29|7.79||||||||7.79|-9.29|
72431293|NCT01033643|144374705|OTHER|Linear Model|Mean Difference from Placebo|-3.73|||||TWO_SIDED|90.0|-14.32|6.86||||||||6.86|-14.32|
72431294|NCT01033643|144374705|OTHER|Linear Model|Mean Difference from Placebo|0.66|||||TWO_SIDED|90.0|-7.88|9.2||||||||9.20|-7.88|
72431295|NCT01033643|144374705|OTHER|Linear Model|Mean Difference from Placebo|-9.92|||||TWO_SIDED|90.0|-19.54|-0.3||||||||-0.30|-19.54|
72431296|NCT01033643|144374706|OTHER|Linear Model|Mean Difference from Placebo|-1.02|||||TWO_SIDED|90.0|-9.36|7.32||||||||7.32|-9.36|
72431297|NCT01033643|144374706|OTHER|Linear Model|Mean Difference from Placebo|-2.12|||||TWO_SIDED|90.0|-12.47|8.22||||||||8.22|-12.47|
72431298|NCT01033643|144374706|OTHER|Linear Model|Mean Difference from Placebo|-0.53|||||TWO_SIDED|90.0|-8.87|7.81||||||||7.81|-8.87|
72431299|NCT01033643|144374706|OTHER|Linear Model|Mean Difference from Placebo|-10.44|||||TWO_SIDED|90.0|-19.83|-1.04||||||||-1.04|-19.83|
72431300|NCT01033643|144374707|OTHER|Linear Model|Mean Difference from Placebo|-1.73|||||TWO_SIDED|90.0|-6.5|3.04||||||||3.04|-6.50|
72431301|NCT01033643|144374707|OTHER|Linear Model|Mean Difference from Placebo|-4.23|||||TWO_SIDED|90.0|-9.0|0.54||||||||0.54|-9.00|
72431302|NCT01033643|144374707|OTHER|Linear Model|Mean Difference from Placebo|-1.05|||||TWO_SIDED|90.0|-5.82|3.72||||||||3.72|-5.82|
72431303|NCT01033643|144374707|OTHER|Linear Model|Mean Difference from Placebo|-2.0|||||TWO_SIDED|90.0|-3.46|7.46||||||||7.46|-3.46|
72431304|NCT01033643|144374708|OTHER|Linear Model|Mean Difference from Placebo|-3.87|||||TWO_SIDED|90.0|-9.37|1.64||||||||1.64|-9.37|
72431305|NCT01033643|144374708|OTHER|Linear Model|Mean Difference from Placebo|-7.2|||||TWO_SIDED|90.0|-14.03|-0.37||||||||-0.37|-14.03|
72431306|NCT01033643|144374708|OTHER|Linear Model|Mean Difference from Placebo|-1.33|||||TWO_SIDED|90.0|-6.83|4.18||||||||4.18|-6.83|
72431307|NCT01033643|144374708|OTHER|Linear Model|Mean Difference from Placebo|-2.24|||||TWO_SIDED|90.0|-8.45|3.96||||||||3.96|-8.45|
72431308|NCT01033643|144374709|OTHER|Linear Model|Mean Difference from Placebo|-2.74|||||TWO_SIDED|90.0|-7.92|2.43||||||||2.43|-7.92|
72431309|NCT01033643|144374709|OTHER|Linear Model|Mean Difference from Placebo|-6.67|||||TWO_SIDED|90.0|-13.09|-0.25||||||||-0.25|-13.09|
72431310|NCT01033643|144374709|OTHER|Linear Model|Mean Difference from Placebo|-0.74|||||TWO_SIDED|90.0|-5.91|4.44||||||||4.44|-5.91|
72431311|NCT01033643|144374709|OTHER|Linear Model|Mean Difference from Placebo|-2.81|||||TWO_SIDED|90.0|-8.64|3.02||||||||3.02|-8.64|
72431312|NCT01033643|144374710|OTHER|Linear Model|Geometric Mean Ratio (GMR)|0.94|||||TWO_SIDED|90.0|0.47|1.87|||||GMR was calculated as MK-3614 Dose divided by Placebo|||1.87|0.47|
72431313|NCT01033643|144374710|OTHER|Linear Model|Geometric Mean Ratio (GMR)|0.48|||||TWO_SIDED|90.0|0.26|0.87|||||GMR was calculated as MK-3614 Dose divided by Placebo|||0.87|0.26|
72431314|NCT01033643|144374710|OTHER|Linear Model|Geometric Mean Ratio (GMR)|0.95|||||TWO_SIDED|90.0|0.51|1.79|||||GMR was calculated as MK-3614 Dose divided by Placebo|||1.79|0.51|
72431315|NCT02028884|144374735|SUPERIORITY||Hazard Ratio (HR)|0.38||||0.0184|TWO_SIDED|95.0|0.16|0.88|||Log Rank|||Stratified by Baseline annualized relapse rate (ARR: 1, \> 1) and geographic region (Asia, EU/Other).||0.88|0.16|0.0184
72431316|NCT02028884|144374736|SUPERIORITY||Mean Difference (Final Values)|6.376|STANDARD_ERROR_OF_MEAN|3.344||0.0602|TWO_SIDED|95.0|-0.28|13.033|||ANCOVA|ANCOVA model: treatment group as fixed effect and baseline measurements, prior therapy, most recent attack (first attack/relapse) as covariates.||||13.033|-0.280|0.0602
72431317|NCT02028884|144374737|SUPERIORITY||Mean Difference (Final Values)|-2.089|STANDARD_ERROR_OF_MEAN|1.338||0.1224|TWO_SIDED|95.0|-4.752|0.574|||ANCOVA|ANCOVA model: treatment group as fixed effect and baseline measurements, prior therapy, most recent attack (first attack/relapse) as covariates.||||0.574|-4.752|0.1224
72431318|NCT02373813|144374766|SUPERIORITY||Risk Difference (RD)|20.8|STANDARD_ERROR_OF_MEAN|6.7||0.004|TWO_SIDED|95.0|7.6|33.9||The risk difference and its p-value were estimated from the chi-squared test with continuity correction.|Chi-squared, Corrected|||||33.9|7.6|0.004
72431319|NCT02373813|144374767|SUPERIORITY||Risk Difference (RD)|24.2|STANDARD_ERROR_OF_MEAN|8.3||0.006|TWO_SIDED|95.0|7.9|40.5||The risk difference and its p-value were estimated from the chi-squared test with continuity correction.|Chi-squared, Corrected|||||40.5|7.9|0.006
72363927|NCT03773978|144239533|SUPERIORITY||Odds Ratio (OR)|3.7|||<|0.001|TWO_SIDED|95.0|1.85|7.41|||Regression, Logistic|||at week 40||7.41|1.85|<0.001
72363928|NCT03773978|144239533|SUPERIORITY||Odds Ratio (OR)|3.27|||<|0.001|TWO_SIDED|95.0|1.65|6.5|||Regression, Logistic|||at week 44||6.50|1.65|<0.001
72431320|NCT02373813|144374768|SUPERIORITY||Treatment Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.19||0.58|TWO_SIDED|95.0|-0.48|0.27|||two sample t-test|||Baseline||0.27|-0.48|0.58
72431321|NCT02373813|144374768|SUPERIORITY||Treatment Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.17||0.85|TWO_SIDED|95.0|-0.37|0.31|||two sample t-test|||Baseline||0.31|-0.37|0.85
72431322|NCT02373813|144374768|SUPERIORITY||Treatment Difference|-2.61|STANDARD_ERROR_OF_MEAN|1.66||0.12|TWO_SIDED|95.0|-5.89|0.67|||two sample t-test|||Week 12||0.67|-5.89|0.12
72431323|NCT02373813|144374768|SUPERIORITY||Treatment Difference|-2.64|STANDARD_ERROR_OF_MEAN|1.26||0.037|TWO_SIDED|95.0|-5.12|-0.16|||two sample t-test|||Week 12||-0.16|-5.12|0.037
72431324|NCT02373813|144374768|SUPERIORITY||Treatment Difference|-2.33|STANDARD_ERROR_OF_MEAN|1.46||0.063|TWO_SIDED|95.0|-4.8|0.13|||two sample t-test|||Week 24||0.13|-4.80|0.063
72431325|NCT02373813|144374768|SUPERIORITY||Treatment Difference|-0.63|STANDARD_ERROR_OF_MEAN|1.34||0.64|TWO_SIDED|95.0|-3.27|2.01|||two sample t-test|||Week 24||2.01|-3.27|0.64
72431326|NCT02373813|144374768|SUPERIORITY||Treatment Difference|-1.62|STANDARD_ERROR_OF_MEAN|0.9||0.031|TWO_SIDED|95.0|-3.09|-0.15|||two sample t-test|||Week 36||-0.15|-3.09|0.031
72431327|NCT02373813|144374768|SUPERIORITY||Treatment Difference|-1.77|STANDARD_ERROR_OF_MEAN|0.71||0.015|TWO_SIDED|95.0|-3.2|-0.35|||two sample t-test|||Week 36||-0.35|-3.20|0.015
72431328|NCT02373813|144374768|SUPERIORITY||Treatment Difference|-0.55|STANDARD_ERROR_OF_MEAN|0.87||0.58|TWO_SIDED|95.0|-2.55|1.45|||two sample t-test|||Week 48||1.45|-2.55|0.58
72431329|NCT02373813|144374768|SUPERIORITY||Treatment Difference|-1.08|STANDARD_ERROR_OF_MEAN|0.45||0.02|TWO_SIDED|95.0|-1.99|-0.17|||two sample t-test|||Week 48||-0.17|-1.99|0.020
72431330|NCT02373813|144374769|SUPERIORITY||Treatment Difference|-2.46|STANDARD_ERROR_OF_MEAN|1.63||0.13|TWO_SIDED|95.0|-5.68|0.77|||two sample t-test|||Change at Week 12||0.77|-5.68|0.13
72431331|NCT02373813|144374769|SUPERIORITY||Treatment Difference|-2.53|STANDARD_ERROR_OF_MEAN|1.25||0.045|TWO_SIDED|95.0|-4.99|-0.06|||two sample t-test|||Change at Week 12||-0.06|-4.99|0.045
72431332|NCT02373813|144374769|SUPERIORITY||Treatment Difference|-2.27|STANDARD_ERROR_OF_MEAN|1.45||0.071|TWO_SIDED|95.0|-4.75|0.2|||two sample t-test|||Change at Week 24||0.20|-4.75|0.071
72431333|NCT02373813|144374769|SUPERIORITY||Treatment Difference|-0.64|STANDARD_ERROR_OF_MEAN|1.34||0.63|TWO_SIDED|95.0|-3.28|2.0|||two sample t-test|||Change at Week 24||2.00|-3.28|0.63
72431334|NCT02373813|144374769|SUPERIORITY||Treatment Difference|-1.61|STANDARD_ERROR_OF_MEAN|0.91||0.037|TWO_SIDED|95.0|-3.11|-0.1|||two sample t-test|||Change at Week 36||-0.10|-3.11|0.037
72431335|NCT02373813|144374769|SUPERIORITY||Treatment Difference|-1.84|STANDARD_ERROR_OF_MEAN|0.73||0.013|TWO_SIDED|95.0|-3.3|-0.39|||two sample t-test|||Change at Week 36||-0.39|-3.30|0.013
72431336|NCT02373813|144374769|SUPERIORITY||Treatment Difference|-0.51|STANDARD_ERROR_OF_MEAN|0.88||0.62|TWO_SIDED|95.0|-2.54|1.53|||two sample t-test|||Change at Week 48||1.53|-2.54|0.62
72431337|NCT02373813|144374769|SUPERIORITY||Treatment Difference|-1.12|STANDARD_ERROR_OF_MEAN|0.45||0.015|TWO_SIDED|95.0|-2.02|-0.22|||two sample t-test|||Change at Week 48||-0.22|-2.02|0.015
72431338|NCT02373813|144374770|SUPERIORITY||Treatment Difference|0.04|STANDARD_ERROR_OF_MEAN|0.11||0.75|TWO_SIDED|95.0|-0.19|0.26|||two sample t-test|||Baseline||0.26|-0.19|0.75
72431339|NCT02373813|144374770|SUPERIORITY||Treatment Difference|0.08|STANDARD_ERROR_OF_MEAN|0.1||0.43|TWO_SIDED|95.0|-0.11|0.27|||two sample t-test|||Baseline||0.27|-0.11|0.43
72431340|NCT02373813|144374770|SUPERIORITY||Treatment Difference|-0.46|STANDARD_ERROR_OF_MEAN|0.23||0.049|TWO_SIDED|95.0|-0.91|0.0|||two sample t-test|||Week 12||0.00|-0.91|0.049
72431341|NCT02373813|144374770|SUPERIORITY||Treatment Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.19||0.032|TWO_SIDED|95.0|-0.77|-0.04|||two sample t-test|||Week 12||-0.04|-0.77|0.032
72363929|NCT03773978|144239534|SUPERIORITY||Odds Ratio (OR)|1.25||||0.568|TWO_SIDED|95.0|0.59|2.65|||Regression, Logistic|||at week 16||2.65|0.59|0.568
72363930|NCT03773978|144239534|SUPERIORITY||Odds Ratio (OR)|2.92||||0.004|TWO_SIDED|95.0|1.4|6.09|||Regression, Logistic|||at week 20||6.09|1.40|0.004
72363931|NCT03773978|144239534|SUPERIORITY||Odds Ratio (OR)|4.38|||<|0.001|TWO_SIDED|95.0|2.1|9.15|||Regression, Logistic|||at week 24||9.15|2.10|<0.001
72363932|NCT03773978|144239534|SUPERIORITY||Odds Ratio (OR)|3.09||||0.002|TWO_SIDED|95.0|1.51|6.32|||Regression, Logistic|||at week 28||6.32|1.51|0.002
72363933|NCT03773978|144239534|SUPERIORITY||Odds Ratio (OR)|2.99||||0.003|TWO_SIDED|95.0|1.47|6.11|||Regression, Logistic|||at week 32||6.11|1.47|0.003
72363934|NCT03773978|144239534|SUPERIORITY||Odds Ratio (OR)|2.84||||0.003|TWO_SIDED|95.0|1.44|5.6|||Regression, Logistic|||at week 36||5.60|1.44|0.003
72363935|NCT03773978|144239534|SUPERIORITY||Odds Ratio (OR)|3.49|||<|0.001|TWO_SIDED|95.0|1.74|6.97|||Regression, Logistic|||at week 40||6.97|1.74|<0.001
72363936|NCT03773978|144239534|SUPERIORITY||Odds Ratio (OR)|2.87||||0.002|TWO_SIDED|95.0|1.46|5.66|||Regression, Logistic|||at week 44||5.66|1.46|0.002
72363937|NCT03773978|144239535|SUPERIORITY||Odds Ratio (OR)|0.99||||0.972|TWO_SIDED|95.0|0.52|1.87|||Regression, Logistic|||at week 16||1.87|0.52|0.972
72363938|NCT03773978|144239535|SUPERIORITY||Odds Ratio (OR)|2.47||||0.008|TWO_SIDED|95.0|1.27|4.81|||Regression, Logistic|||at week 20||4.81|1.27|0.008
72363939|NCT03773978|144239535|SUPERIORITY||Odds Ratio (OR)|2.57||||0.005|TWO_SIDED|95.0|1.33|4.97|||Regression, Logistic|||at week 24||4.97|1.33|0.005
72363940|NCT03773978|144239535|SUPERIORITY||Odds Ratio (OR)|3.06|||<|0.001|TWO_SIDED|95.0|1.57|5.94|||Regression, Logistic|||at week 28||5.94|1.57|<0.001
72363941|NCT03773978|144239535|SUPERIORITY||Odds Ratio (OR)|2.42||||0.009|TWO_SIDED|95.0|1.25|4.71|||Regression, Logistic|||at week 32||4.71|1.25|0.009
72363942|NCT03773978|144239535|SUPERIORITY||Odds Ratio (OR)|2.8||||0.003|TWO_SIDED|95.0|1.43|5.47|||Regression, Logistic|||at week 36||5.47|1.43|0.003
72363943|NCT03773978|144239535|SUPERIORITY||Odds Ratio (OR)|2.93||||0.002|TWO_SIDED|95.0|1.47|5.83|||Regression, Logistic|||at week 40||5.83|1.47|0.002
72363944|NCT03773978|144239535|SUPERIORITY||Odds Ratio (OR)|1.93||||0.052|TWO_SIDED|95.0|0.99|3.74|||Regression, Logistic|||at week 44||3.74|0.99|0.052
72363945|NCT03773978|144239536|SUPERIORITY||Odds Ratio (OR)|1.35||||0.409|TWO_SIDED|95.0|0.66|2.75|||Regression, Logistic|||at week 16||2.75|0.66|0.409
72363946|NCT03773978|144239536|SUPERIORITY||Odds Ratio (OR)|2.13||||0.03|TWO_SIDED|95.0|1.07|4.23|||Regression, Logistic|||at week 20||4.23|1.07|0.030
72363947|NCT03773978|144239536|SUPERIORITY||Odds Ratio (OR)|2.36||||0.022|TWO_SIDED|95.0|1.13|4.92|||Regression, Logistic|||at week 24||4.92|1.13|0.022
72363948|NCT03773978|144239536|SUPERIORITY||Odds Ratio (OR)|2.05||||0.04|TWO_SIDED|95.0|1.03|4.08|||Regression, Logistic|||at week 28||4.08|1.03|0.040
72363949|NCT03773978|144239536|SUPERIORITY||Odds Ratio (OR)|2.13||||0.032|TWO_SIDED|95.0|1.07|4.24|||Regression, Logistic|||at week 32||4.24|1.07|0.032
72363950|NCT03773978|144239536|SUPERIORITY||Odds Ratio (OR)|1.71||||0.132|TWO_SIDED|95.0|0.85|3.42|||Regression, Logistic|||at week 36||3.42|0.85|0.132
72363951|NCT03773978|144239536|SUPERIORITY||Odds Ratio (OR)|2.02||||0.05|TWO_SIDED|95.0|1.0|4.1|||Regression, Logistic|||at week 40||4.10|1.00|0.050
72363952|NCT03773978|144239536|SUPERIORITY||Odds Ratio (OR)|2.32||||0.019|TWO_SIDED|95.0|1.15|4.71|||Regression, Logistic|||at week 44||4.71|1.15|0.019
72363953|NCT03773978|144239537|SUPERIORITY||Odds Ratio (OR)|0.8||||0.62|TWO_SIDED|95.0|0.33|1.92|||Regression, Logistic|||at week 16||1.92|0.33|0.620
72363954|NCT03773978|144239537|SUPERIORITY||Odds Ratio (OR)|1.3||||0.492|TWO_SIDED|95.0|0.61|2.78|||Regression, Logistic|||at week 20||2.78|0.61|0.492
72363955|NCT03773978|144239537|SUPERIORITY||Odds Ratio (OR)|1.17||||0.715|TWO_SIDED|95.0|0.5|2.75|||Regression, Logistic|||at week 24||2.75|0.50|0.715
72363956|NCT03773978|144239537|SUPERIORITY||Odds Ratio (OR)|1.4||||0.384|TWO_SIDED|95.0|0.66|2.99|||Regression, Logistic|||at week 28||2.99|0.66|0.384
72363957|NCT03773978|144239537|SUPERIORITY||Odds Ratio (OR)|1.47||||0.311|TWO_SIDED|95.0|0.7|3.1|||Regression, Logistic|||at week 32||3.10|0.70|0.311
72363958|NCT03773978|144239537|SUPERIORITY||Odds Ratio (OR)|1.58||||0.231|TWO_SIDED|95.0|0.75|3.34|||Regression, Logistic|||at week 36||3.34|0.75|0.231
72363959|NCT03773978|144239537|SUPERIORITY||Odds Ratio (OR)|1.82||||0.129|TWO_SIDED|95.0|0.84|3.95|||Regression, Logistic|||at week 40||3.95|0.84|0.129
72363960|NCT03773978|144239537|SUPERIORITY||Odds Ratio (OR)|2.23||||0.043|TWO_SIDED|95.0|1.02|4.84|||Regression, Logistic|||at week 44||4.84|1.02|0.043
72363961|NCT03773978|144239538|SUPERIORITY||Odds Ratio (OR)|1.1||||0.853|TWO_SIDED|95.0|0.4|2.98|||Regression, Logistic|||at week 16||2.98|0.40|0.853
72363962|NCT03773978|144239538|SUPERIORITY||Odds Ratio (OR)|0.7||||0.432|TWO_SIDED|95.0|0.29|1.71|||Regression, Logistic|||at week 20||1.71|0.29|0.432
72363963|NCT03773978|144239538|SUPERIORITY||Odds Ratio (OR)|0.98||||0.96|TWO_SIDED|95.0|0.41|2.31|||Regression, Logistic|||at week 24||2.31|0.41|0.960
72363964|NCT03773978|144239538|SUPERIORITY||Odds Ratio (OR)|1.71||||0.215|TWO_SIDED|95.0|0.73|4.01|||Regression, Logistic|||at week 28||4.01|0.73|0.215
72363965|NCT03773978|144239538|SUPERIORITY||Odds Ratio (OR)|1.8||||0.173|TWO_SIDED|95.0|0.77|4.22|||Regression, Logistic|||at week 32||4.22|0.77|0.173
72363966|NCT03773978|144239538|SUPERIORITY||Odds Ratio (OR)|1.46||||0.367|TWO_SIDED|95.0|0.64|3.33|||Regression, Logistic|||at week 36||3.33|0.64|0.367
72363967|NCT03773978|144239538|SUPERIORITY||Odds Ratio (OR)|1.9||||0.162|TWO_SIDED|95.0|0.77|4.67|||Regression, Logistic|||at week 40||4.67|0.77|0.162
72363968|NCT03773978|144239538|SUPERIORITY||Odds Ratio (OR)|1.96||||0.113|TWO_SIDED|95.0|0.85|4.5|||Regression, Logistic|||at week 44||4.50|0.85|0.113
72363969|NCT03773978|144239539|SUPERIORITY||Odds Ratio (OR)|0.8||||0.511|TWO_SIDED|95.0|0.42|1.55|||Regression, Logistic|||at week 16||1.55|0.42|0.511
72363970|NCT03773978|144239539|SUPERIORITY||Odds Ratio (OR)|1.64||||0.145|TWO_SIDED|95.0|0.84|3.2|||Regression, Logistic|||at week 20||3.20|0.84|0.145
72363971|NCT03773978|144239539|SUPERIORITY||Odds Ratio (OR)|1.38||||0.349|TWO_SIDED|95.0|0.7|2.72|||Regression, Logistic|||at week 24||2.72|0.70|0.349
72363972|NCT03773978|144239539|SUPERIORITY||Odds Ratio (OR)|1.63||||0.167|TWO_SIDED|95.0|0.82|3.25|||Regression, Logistic|||at week 28||3.25|0.82|0.167
72363973|NCT03773978|144239539|SUPERIORITY||Odds Ratio (OR)|1.55||||0.212|TWO_SIDED|95.0|0.78|3.07|||Regression, Logistic|||at week 32||3.07|0.78|0.212
72363974|NCT03773978|144239539|SUPERIORITY||Odds Ratio (OR)|1.21||||0.577|TWO_SIDED|95.0|0.62|2.39|||Regression, Logistic|||at week 36||2.39|0.62|0.577
72431342|NCT02373813|144374770|SUPERIORITY||Treatment Difference|-0.24|STANDARD_ERROR_OF_MEAN|0.2||0.18|TWO_SIDED|95.0|-0.58|0.11|||two sample t-test|||Week 24||0.11|-0.58|0.18
72431343|NCT02373813|144374770|SUPERIORITY||Treatment Difference|0.14|STANDARD_ERROR_OF_MEAN|0.19||0.48|TWO_SIDED|95.0|-0.24|0.51|||two sample t-test|||Week 24||0.51|-0.24|0.48
72431344|NCT02373813|144374770|SUPERIORITY||Treatment Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.17||0.35|TWO_SIDED|95.0|-0.51|0.18|||two sample t-test|||Week 36||0.18|-0.51|0.35
72431345|NCT02373813|144374770|SUPERIORITY||Treatment Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.13||0.28|TWO_SIDED|95.0|-0.41|0.12|||two sample t-test|||Week 36||0.12|-0.41|0.28
72431346|NCT02373813|144374770|SUPERIORITY||Treatment Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.16||0.48|TWO_SIDED|95.0|-0.44|0.21|||two sample t-test|||Week 48||0.21|-0.44|0.48
72431347|NCT02373813|144374770|SUPERIORITY||Treatment Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.13||0.92|TWO_SIDED|95.0|-0.26|0.24|||two sample t-test|||Week 48||0.24|-0.26|0.92
72431348|NCT02373813|144374771|SUPERIORITY||Treatment Difference|-0.48|STANDARD_ERROR_OF_MEAN|0.22||0.032|TWO_SIDED|95.0|-0.91|-0.04|||two sample t-test|||Change at Week 12||-0.04|-0.91|0.032
72363975|NCT03773978|144239539|SUPERIORITY||Odds Ratio (OR)|1.51||||0.225|TWO_SIDED|95.0|0.78|2.95|||Regression, Logistic|||at week 40||2.95|0.78|0.225
72363976|NCT03773978|144239539|SUPERIORITY||Odds Ratio (OR)|1.96||||0.055|TWO_SIDED|95.0|0.98|3.9|||Regression, Logistic|||at week 44||3.90|0.98|0.055
72363977|NCT03773978|144239541|SUPERIORITY||LS Mean difference|-4.33|STANDARD_ERROR_OF_MEAN|1.328||0.001|TWO_SIDED|95.0|-6.95|-1.7|||ANCOVA|||||-1.70|-6.95|0.001
72431349|NCT02373813|144374771|SUPERIORITY||Treatment Difference|-0.46|STANDARD_ERROR_OF_MEAN|0.16||0.005|TWO_SIDED|95.0|-0.78|-0.15|||two sample t-test|||Change at Week 12||-0.15|-0.78|0.005
72431350|NCT02373813|144374771|SUPERIORITY||Treatment Difference|-0.31|STANDARD_ERROR_OF_MEAN|0.18||0.058|TWO_SIDED|95.0|-0.63|0.01|||two sample t-test|||Change at Week 24||0.01|-0.63|0.058
72431351|NCT02373813|144374771|SUPERIORITY||Treatment Difference|0.05|STANDARD_ERROR_OF_MEAN|0.17||0.78|TWO_SIDED|95.0|-0.29|0.38|||two sample t-test|||Change at Week 24||0.38|-0.29|0.78
72431352|NCT02373813|144374771|SUPERIORITY||Treatment Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.16||0.27|TWO_SIDED|95.0|-0.49|0.14|||two sample t-test|||Change at Week 36||0.14|-0.49|0.27
72431353|NCT02373813|144374771|SUPERIORITY||Treatment Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.12||0.078|TWO_SIDED|95.0|-0.47|0.03|||two sample t-test|||Change at Week 36||0.03|-0.47|0.078
72431354|NCT02373813|144374771|SUPERIORITY||Treatment Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.16||0.47|TWO_SIDED|95.0|-0.43|0.2|||two sample t-test|||Week 48||0.20|-0.43|0.47
72431355|NCT02373813|144374771|SUPERIORITY||Treatment Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.11||0.39|TWO_SIDED|95.0|-0.33|0.13|||two sample t-test|||Change at Week 48||0.13|-0.33|0.39
72431356|NCT02373813|144374772|SUPERIORITY||Treatment Difference|0.03|STANDARD_ERROR_OF_MEAN|0.06||0.6|TWO_SIDED|95.0|-0.09|0.15|||two sample t-test|||Baseline||0.15|-0.09|0.60
72431357|NCT02373813|144374772|SUPERIORITY||Treatment Difference|0.0|STANDARD_ERROR_OF_MEAN|0.05||0.97|TWO_SIDED|95.0|-0.1|0.1|||two sample t-test|||Baseline||0.10|-0.10|0.97
72431358|NCT02373813|144374772|SUPERIORITY||Treatment Difference|-0.41|STANDARD_ERROR_OF_MEAN|0.2||0.044|TWO_SIDED|95.0|-0.82|-0.01|||two sample t-test|||Week 12||-0.01|-0.82|0.044
72431359|NCT02373813|144374772|SUPERIORITY||Treatment Difference|-0.45|STANDARD_ERROR_OF_MEAN|0.16||0.004|TWO_SIDED|95.0|-0.76|-0.14|||two sample t-test|||Week 12||-0.14|-0.76|0.004
72431360|NCT02373813|144374772|SUPERIORITY||Treatment Difference|-0.38|STANDARD_ERROR_OF_MEAN|0.17||0.009|TWO_SIDED|95.0|-0.66|-0.1|||two sample t-test|||Week 24||-0.10|-0.66|0.009
72431361|NCT02373813|144374772|SUPERIORITY||Treatment Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.16||0.34|TWO_SIDED|95.0|-0.46|0.16|||two sample t-test|||Week 24||0.16|-0.46|0.34
72431362|NCT02373813|144374772|SUPERIORITY||Treatment Difference|-0.24|STANDARD_ERROR_OF_MEAN|0.13||0.046|TWO_SIDED|95.0|-0.47|0.0|||two sample t-test|||Week 36||0.00|-0.47|0.046
72431363|NCT02373813|144374772|SUPERIORITY||Treatment Difference|-0.29|STANDARD_ERROR_OF_MEAN|0.1||0.006|TWO_SIDED|95.0|-0.49|-0.08|||two sample t-test|||Week 36||-0.08|-0.49|0.006
72363978|NCT03773978|144239542|SUPERIORITY||LS Mean difference|-12.97|STANDARD_ERROR_OF_MEAN|4.262||0.003|TWO_SIDED|95.0|-21.39|-4.55|||ANCOVA|||||-4.55|-21.39|0.003
72363979|NCT03773978|144239543|SUPERIORITY||LS Mean difference|-0.35|STANDARD_ERROR_OF_MEAN|0.526||0.574|TWO_SIDED|95.0|-2.62|1.91|||ANCOVA|||||1.91|-2.62|0.574
72363980|NCT03773978|144239544|SUPERIORITY||LS Mean difference|0.45|STANDARD_ERROR_OF_MEAN|0.348||0.208|TWO_SIDED|95.0|-0.26|1.15|||ANCOVA|||||1.15|-0.26|0.208
72363981|NCT03773978|144239545|SUPERIORITY||LS Mean difference|-1.08|STANDARD_ERROR_OF_MEAN|0.438||0.019|TWO_SIDED|95.0|-1.98|-0.19|||ANCOVA|||||-0.19|-1.98|0.019
72363982|NCT04672239|144239678|SUPERIORITY||Mean Difference (Final Values)|7.3341||||0.0219|TWO_SIDED|95.0|1.0734|13.5948||We used hierarchical linear mixed models with maximum likelihood estimation of all available longitudinal data to handle missing data, then used a planned, pairwise comparison to test for end-of-treatment group differences.|Mixed Models Analysis||Model-estimated difference for the pairwise group difference at week 6 post-quit (end-of-treatment).|This proof-of-concept RCT was powered to detect an effect size of d=0.50 between SiS3 and either of the two control groups. Using SAS PROC POWER, it was determined that a sample size of n=64 per group would be needed to detect this effect in a 2-sided t-test with p=.05. Assuming a retention rate of 85%, it was determined that one needed to enroll n=75 per group in order to retain n=64 by end of treatment.||13.5948|1.0734|0.0219
72363983|NCT04672239|144239678|SUPERIORITY||Mean Difference (Final Values)|8.7775||||0.0072|TWO_SIDED|95.0|2.407|15.148||We used hierarchical linear mixed models with maximum likelihood estimation of all available longitudinal data to handle missing data, then used a planned, pairwise comparison to test for end-of-treatment group differences.|Mixed Models Analysis||Model-estimated difference for the pairwise group difference at week 6 post-quit (end-of-treatment).|This proof-of-concept RCT was powered to detect an effect size of d=0.50 between SiS3 and either of the two control groups. Using SAS PROC POWER, it was determined that a sample size of n=64 per group would be needed to detect this effect in a 2-sided t-test with p=.05. Assuming a retention rate of 85%, it was determined that one needed to enroll n=75 per group in order to retain n=64 by end of treatment.||15.1480|2.4070|0.0072
72431364|NCT02373813|144374772|SUPERIORITY||Treatment Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.13||0.25|TWO_SIDED|95.0|-0.4|-0.1|||two sample t-test|||Week 48||-0.10|-0.40|0.25
72431365|NCT02373813|144374772|SUPERIORITY||Treatment Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.08||0.021|TWO_SIDED|95.0|-0.37|-0.03|||two sample t-test|||Week 48||-0.03|-0.37|0.021
72431366|NCT02373813|144374773|SUPERIORITY||Treatment Difference|-0.43|STANDARD_ERROR_OF_MEAN|0.2||0.03|TWO_SIDED|95.0|-0.82|-0.04|||two sample t-test|||Change at Week 12||-0.04|-0.82|0.030
72431367|NCT02373813|144374773|SUPERIORITY||Treatment Difference|-0.42|STANDARD_ERROR_OF_MEAN|0.15||0.005|TWO_SIDED|95.0|-0.72|-0.13|||two sample t-test|||Change at Week 12||-0.13|-0.72|0.005
72431368|NCT02373813|144374773|SUPERIORITY||Treatment Difference|-0.42|STANDARD_ERROR_OF_MEAN|0.16||0.002|TWO_SIDED|95.0|-0.69|-0.15|||two sample t-test|||Change at Week 24||-0.15|-0.69|0.002
72431369|NCT02373813|144374773|SUPERIORITY||Treatment Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.16||0.34|TWO_SIDED|95.0|-0.46|0.16|||two sample t-test|||Change at Week 24||0.16|-0.46|0.34
72431370|NCT02373813|144374773|SUPERIORITY||Treatment Difference|-0.29|STANDARD_ERROR_OF_MEAN|0.13||0.014|TWO_SIDED|95.0|-0.52|-0.06|||two sample t-test|||Change at Week 36||-0.06|-0.52|0.014
72431371|NCT02373813|144374773|SUPERIORITY||Treatment Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.1||0.004|TWO_SIDED|95.0|-0.51|-0.1|||two sample t-test|||Change at Week 36||-0.10|-0.51|0.004
72431372|NCT02373813|144374773|SUPERIORITY||Treatment Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.12||0.12|TWO_SIDED|95.0|-0.43|0.05|||two sample t-test|||Change at Week 48||0.05|-0.43|0.12
72431373|NCT02373813|144374773|SUPERIORITY||Treatment Difference|-0.21|STANDARD_ERROR_OF_MEAN|0.08||0.01|TWO_SIDED|95.0|-0.37|-0.05|||two sample t-test|||Change at Week 48||-0.05|-0.37|0.010
72431374|NCT02373813|144374774|SUPERIORITY||Treatment Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.16||0.067|TWO_SIDED|95.0|-0.62|0.02|||two sample t-test|||Baseline||0.02|-0.62|0.067
72431375|NCT02373813|144374774|SUPERIORITY||Treatment Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.16||0.59|TWO_SIDED|95.0|-0.41|0.23|||two sample t-test|||Baseline||0.23|-0.41|0.59
72431376|NCT02373813|144374774|SUPERIORITY||Treatment Difference|-2.46|STANDARD_ERROR_OF_MEAN|1.62||0.13||95.0|-5.66|0.74|||two sample t-test|||Week 12||0.74|-5.66|0.13
72431377|NCT02373813|144374774|SUPERIORITY||Treatment Difference|-2.34|STANDARD_ERROR_OF_MEAN|1.23||0.059|TWO_SIDED|95.0|-4.76|0.09|||two sample t-test|||Week 12||0.09|-4.76|0.059
72431378|NCT02373813|144374774|SUPERIORITY||Treatment Difference|-2.72|STANDARD_ERROR_OF_MEAN|1.38||0.017|TWO_SIDED|95.0|-4.95|-0.5|||two sample t-test|||Week 24||-0.50|-4.95|0.017
72431379|NCT02373813|144374774|SUPERIORITY||Treatment Difference|-0.44|STANDARD_ERROR_OF_MEAN|1.32||0.74|TWO_SIDED|95.0|-3.04|2.15|||two sample t-test|||Week 24||2.15|-3.04|0.74
72431380|NCT02373813|144374774|SUPERIORITY||Treatment Difference|-1.56|STANDARD_ERROR_OF_MEAN|0.9||0.039|TWO_SIDED|95.0|-3.03|-0.08|||two sample t-test|||Week 36||-0.08|-3.03|0.039
72431381|NCT02373813|144374774|SUPERIORITY||Treatment Difference|-1.66|STANDARD_ERROR_OF_MEAN|0.72||0.023|TWO_SIDED|95.0|-3.1|-0.23|||two sample t-test|||Week 36||-0.23|-3.10|0.023
72431382|NCT02373813|144374774|SUPERIORITY||Treatment Difference|-0.46|STANDARD_ERROR_OF_MEAN|0.85||0.65|TWO_SIDED|95.0|-2.43|1.52|||two sample t-test|||Week 48||1.52|-2.43|0.65
72431383|NCT02373813|144374774|SUPERIORITY||Treatment Difference|-1.07|STANDARD_ERROR_OF_MEAN|0.44||0.017|TWO_SIDED|95.0|-1.94|-0.19|||two sample t-test|||Week 48||-0.19|-1.94|0.017
72431384|NCT02373813|144374775|SUPERIORITY||Treatment Difference|-2.15|STANDARD_ERROR_OF_MEAN|1.59||0.18||95.0|-5.29|1.0|||two sample t-test|||Change at Week 12||1.00|-5.29|0.18
72431385|NCT02373813|144374775|SUPERIORITY||Treatment Difference|-2.24|STANDARD_ERROR_OF_MEAN|1.21||0.067|TWO_SIDED|95.0|-4.63|0.16|||two sample t-test|||Change at Week 12||0.16|-4.63|0.067
72431386|NCT02373813|144374775|SUPERIORITY||Treatment Difference|-2.4|STANDARD_ERROR_OF_MEAN|1.37||0.035|TWO_SIDED|95.0|-4.62|-0.17|||two sample t-test|||Change at Week 24||-0.17|-4.62|0.035
72431387|NCT02373813|144374775|SUPERIORITY||Treatment Difference|-0.34|STANDARD_ERROR_OF_MEAN|1.3||0.79|TWO_SIDED|95.0|-2.91|2.23|||two sample t-test|||Change at Week 24||2.23|-2.91|0.79
72431388|NCT02373813|144374775|SUPERIORITY||Treatment Difference|-1.27|STANDARD_ERROR_OF_MEAN|0.91||0.09|TWO_SIDED|95.0|-2.75|0.2|||two sample t-test|||Change at Week 36||0.20|-2.75|0.090
72431389|NCT02373813|144374775|SUPERIORITY||Treatment Difference|-1.61|STANDARD_ERROR_OF_MEAN|0.72||0.029|TWO_SIDED|95.0|-3.06|-0.17|||two sample t-test|||Change at Week 36||-0.17|-3.06|0.029
72431390|NCT02373813|144374775|SUPERIORITY||Treatment Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.84||0.86|TWO_SIDED|95.0|-2.15|1.81|||two sample t-test|||Change at Week 48||1.81|-2.15|0.86
72431391|NCT02373813|144374775|SUPERIORITY||Treatment Difference|-1.02|STANDARD_ERROR_OF_MEAN|0.43||0.021|TWO_SIDED|95.0|-1.88|-0.16|||two sample t-test|||Change at Week 48||-0.16|-1.88|0.021
72431392|NCT02373813|144374776|SUPERIORITY||Risk Difference (RD)|0.1|STANDARD_ERROR_OF_MEAN|3.4||1|TWO_SIDED|95.0|-6.5|6.6||The risk difference and its p-value were estimated from the Chi-squared test with continuity correction.|Chi-squared, Corrected|||Baseline||6.6|-6.5|1.00
72431393|NCT02373813|144374776|SUPERIORITY||Risk Difference (RD)|-3.9|STANDARD_ERROR_OF_MEAN|3.3||0.38|TWO_SIDED|95.0|-10.4|2.6||The risk difference and its p-value were estimated from the Chi-squared test with continuity correction.|Chi-squared, Corrected|||Baseline||2.6|-10.4|0.38
72431394|NCT02373813|144374776|SUPERIORITY||Risk Difference (RD)|24.5|STANDARD_ERROR_OF_MEAN|7.9||0.007|TWO_SIDED|95.0|9.0|40.0|||Chi-squared, Corrected|||Week 12||40.0|9.0|0.007
72431395|NCT02373813|144374776|SUPERIORITY||Risk Difference (RD)|14.0|STANDARD_ERROR_OF_MEAN|6.9||0.063|TWO_SIDED|95.0|0.4|27.6||The risk difference and its p-value were estimated from the Chi-squared test with continuity correction.|Chi-squared, Corrected|||Week 12||27.6|0.4|0.063
72431396|NCT02373813|144374776|SUPERIORITY||Risk Difference (RD)|23.2|STANDARD_ERROR_OF_MEAN|8.4||0.012|TWO_SIDED|95.0|6.7|39.8|||Chi-squared, Corrected|||Week 24||39.8|6.7|0.012
72431397|NCT02373813|144374776|SUPERIORITY||Risk Difference (RD)|17.8|STANDARD_ERROR_OF_MEAN|7.0||0.018|TWO_SIDED|95.0|4.1|31.5||The risk difference and its p-value were estimated from the Chi-squared test with continuity correction.|Chi-squared, Corrected|||Week 24||31.5|4.1|0.018
72431398|NCT02373813|144374776|SUPERIORITY||Risk Difference (RD)|19.0|STANDARD_ERROR_OF_MEAN|8.6||0.044|TWO_SIDED|95.0|2.1|35.9|||Chi-squared, Corrected|||Week 36||35.9|2.1|0.044
72431399|NCT02373813|144374776|SUPERIORITY||Risk Difference (RD)|19.5|STANDARD_ERROR_OF_MEAN|7.0||0.01|TWO_SIDED|95.0|5.8|33.2|||Chi-squared, Corrected|||Week 36||33.2|5.8|0.010
72431400|NCT02373813|144374776|SUPERIORITY||Risk Difference (RD)|25.7|STANDARD_ERROR_OF_MEAN|8.6||0.005|TWO_SIDED|95.0|8.9|42.5||The risk difference and its p-value were estimated from the Chi-squared test with continuity correction.|Chi-squared, Corrected|||Week 48||42.5|8.9|0.005
72431401|NCT02373813|144374776|SUPERIORITY||Risk Difference (RD)|21.6|STANDARD_ERROR_OF_MEAN|7.0||0.004|TWO_SIDED|95.0|7.9|35.2||The risk difference and its p-value were estimated from the Chi-squared test with continuity correction.|Chi-squared, Corrected|||Week 48||35.2|7.9|0.004
72431402|NCT02373813|144374777|SUPERIORITY||Risk Difference (RD)|11.1|STANDARD_ERROR_OF_MEAN|8.4||0.25|TWO_SIDED|95.0|-5.4|27.6||The risk difference and its p-value were estimated from the Chi-squared test with continuity correction.|Chi-squared, Corrected|||Baseline||27.6|-5.4|0.25
72431403|NCT02373813|144374777|SUPERIORITY||Risk Difference (RD)|0.7|STANDARD_ERROR_OF_MEAN|6.7||1|TWO_SIDED|95.0|-12.5|13.8||The risk difference and its p-value were estimated from the Chi-squared test with continuity correction.|Chi-squared, Corrected|||Baseline||13.8|-12.5|1.00
72431404|NCT02373813|144374777|SUPERIORITY||Risk Difference (RD)|1.6|STANDARD_ERROR_OF_MEAN|6.8||0.98|TWO_SIDED|95.0|-11.6|14.9||The risk difference and its p-value were estimated from the Chi-squared test with continuity correction.|Chi-squared, Corrected|||Week 12||14.9|-11.6|0.98
72431405|NCT02373813|144374777|SUPERIORITY||Risk Difference (RD)|5.0|STANDARD_ERROR_OF_MEAN|5.7||0.48|TWO_SIDED|95.0|-6.2|16.2||The risk difference and its p-value were estimated from the Chi-squared test with continuity correction.|Chi-squared, Corrected|||Week 12||16.2|-6.2|0.48
72431406|NCT02373813|144374777|SUPERIORITY||Risk Difference (RD)|11.3|STANDARD_ERROR_OF_MEAN|7.3||0.16|TWO_SIDED|95.0|-3.1|25.7||The risk difference and its p-value were estimated from the Chi-squared test with continuity correction.|Chi-squared, Corrected|||Week 24||25.7|-3.1|0.16
72431407|NCT02373813|144374777|SUPERIORITY||Risk Difference (RD)|1.4|STANDARD_ERROR_OF_MEAN|5.3||0.94|TWO_SIDED|95.0|-9.0|11.9||The risk difference and its p-value were estimated from the Chi-squared test with continuity correction.|Chi-squared, Corrected|||Week 24||11.9|-9.0|0.94
72431408|NCT02373813|144374777|SUPERIORITY||Risk Difference (RD)|12.5|STANDARD_ERROR_OF_MEAN|7.4||0.12|TWO_SIDED|95.0|-2.1|27.0||The risk difference and its p-value were estimated from the Chi-squared test with continuity correction.|Chi-squared, Corrected|||Week 36||27.0|-2.1|0.12
72431409|NCT02373813|144374777|SUPERIORITY||Risk Difference (RD)|5.8|STANDARD_ERROR_OF_MEAN|5.6||0.4|TWO_SIDED|95.0|-5.2|16.8||The risk difference and its p-value were estimated from the Chi-squared test with continuity correction.|Chi-squared, Corrected|||Week 36||16.8|-5.2|0.40
72431410|NCT02373813|144374777|SUPERIORITY||Risk Difference (RD)|5.3|STANDARD_ERROR_OF_MEAN|7.7||0.63|TWO_SIDED|95.0|-9.8|20.4||The risk difference and its p-value were estimated from the Chi-squared test with continuity correction.|Chi-squared, Corrected|||Week 48||20.4|-9.8|0.63
72431411|NCT02373813|144374777|SUPERIORITY||Risk Difference (RD)|-6.9|STANDARD_ERROR_OF_MEAN|5.7||0.31|TWO_SIDED|95.0|-18.0|4.2||The risk difference and its p-value were estimated from the Chi-squared test with continuity correction.|Chi-squared, Corrected|||Week 48||4.2|-18.0|0.31
72431412|NCT02373813|144374779|SUPERIORITY||||||<|0.001||||||P-value was based on the Log-rank test for overall difference on disease-worsening event between two groups.|Log Rank|||||||< 0.001
72431413|NCT02373813|144374779|SUPERIORITY||||||<|0.001||||||P-value was based on the Log-rank test for overall difference on disease-worsening event between two groups.|Log Rank|||||||< 0.001
72431414|NCT02373813|144374780|SUPERIORITY|||||||0.31||||||P-value was based on the Log-rank test for overall difference on disease-worsening event between two groups.|Log Rank|||||||0.31
72431415|NCT02373813|144374780|SUPERIORITY|||||||0.51||||||P-value was based on the Log-rank test for overall difference on disease-worsening event between two groups.|Log Rank|||||||0.51
72431416|NCT02373813|144374781|SUPERIORITY||Risk Difference (RD)|12.5|STANDARD_ERROR_OF_MEAN|14.1||0.58|TWO_SIDED|95.0|-15.2|40.2|||Chi-squared, Corrected|||||40.2|-15.2|0.58
72431417|NCT00180674|144374810|SUPERIORITY|||||||0.043|||||||Wilcoxon Signed Ranks test|||||||0.043
72431418|NCT01106976|144374812|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0012||||0.0009|TWO_SIDED||||||t-test, 1 sided|||Paired t-test. Hypothesis of significant cholinergic interval changes over the study interval period.||||0.0009
72431419|NCT00335153|144374852|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
72431420|NCT00335153|144374853|SUPERIORITY_OR_OTHER|||||||0.023|||||||t-test, 2 sided|||||||0.023
72431421|NCT00335153|144374854|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
72431422|NCT00335153|144374855|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
72431423|NCT00335153|144374856|SUPERIORITY_OR_OTHER|||||||0.974|||||||t-test, 2 sided|||||||0.974
72431424|NCT00335153|144374857|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
72431425|NCT00335153|144374858|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
72431426|NCT00335153|144374859|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
72431427|NCT00335153|144374860|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
72431428|NCT00335153|144374861|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
72431429|NCT00335153|144374862|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
72431430|NCT00335153|144374863|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
72431431|NCT00335153|144374864|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
72431432|NCT00335153|144374865|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
72431433|NCT00335153|144374866|SUPERIORITY_OR_OTHER|||||||0.757|||||||t-test, 2 sided|||||||0.757
72431434|NCT00335153|144374867|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
72431435|NCT00335153|144374868|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
72431436|NCT00335153|144374869|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
72431437|NCT00335153|144374870|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
72431438|NCT00335153|144374871|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
72431439|NCT00335153|144374872|SUPERIORITY_OR_OTHER|||||||0.824|||||||t-test, 2 sided|||||||0.824
72431440|NCT03688542|144374875|SUPERIORITY||Slope|-1.4|||<|0.05|TWO_SIDED|95.0|-3.8|1.0|||Regression, Linear|Dependant variable = follow-up value; adjusted for baseline value, canton, avg number of residents, mission||||1.0|-3.8|<0.05
72431441|NCT03688542|144374876|SUPERIORITY||Slope|-0.18|||<|0.05|TWO_SIDED|95.0|-0.39|0.03|||Regression, Linear|Dependant variable = number of PIM DDD at follow-up, adjusted for baseline value, canton, avg number of residents, mission||||0.03|-0.39|<0.05
72431442|NCT03688542|144374877|SUPERIORITY||Slope|-0.035|||<|0.05|TWO_SIDED|95.0|-0.095|0.025|||Regression, Linear|Dependant variable = number of PIM DDD at follow-up, adjusted for baseline value, canton, avg number of residents, mission||||0.025|-0.095|<0.05
72431443|NCT03688542|144374878|SUPERIORITY||Slope|-0.237|||<|0.05|TWO_SIDED|95.0|-0.435|-0.04|||Regression, Linear|Dependant variable = number of PIM DDD at follow-up, adjusted for baseline value, canton, avg number of residents, mission||||-0.040|-0.435|<0.05
72431444|NCT03688542|144374879|SUPERIORITY||Slope|1.55|||<|0.05|TWO_SIDED|95.0|0.164|2.938|||Regression, Linear|Dependent variable = follow-up value, adjusted for baseline value, canton, avg number of residents, interaction between mission and group.||||2.938|0.164|<0.05
72431445|NCT03688542|144374880|SUPERIORITY||Slope|-12.7|||<|0.05|TWO_SIDED|95.0|-21.5|-4.0|||Regression, Linear|Dependent variable = follow-up value, adjusted for baseline value, canton, avg number of residents, interaction between mission and group.||||-4.0|-21.5|<0.05
72431446|NCT03688542|144374881|SUPERIORITY||Slope|-0.165|||<|0.05|TWO_SIDED|95.0|-0.754|0.424|||Regression, Linear|Dependent variable = follow-up value, adjusted for baseline value, canton, avg number of residents||||0.424|-0.754|<0.05
72431447|NCT03688542|144374882|SUPERIORITY||Slope|-4.2|||<|0.05|TWO_SIDED|95.0|-16.0|7.6|||Regression, Linear|Dependent variable = follow-up value, adjusted for baseline value, canton, avg number of residents||||7.6|-16.0|<0.05
72431448|NCT02478359|144374883|SUPERIORITY||Odds Ratio (OR)|1.09||||0.33|TWO_SIDED|95.0|0.92|1.28|||Regression, Logistic|||||1.28|0.92|0.33
72431449|NCT02478359|144374884|SUPERIORITY||Odds Ratio (OR)|1.02||||0.88|TWO_SIDED|95.0|0.77|1.36|||Regression, Logistic|||||1.36|0.77|0.88
72431450|NCT02478359|144374885|SUPERIORITY||Odds Ratio (OR)|1.05||||0.53|TWO_SIDED|95.0|0.89|1.24|||Regression, Logistic|||||1.24|0.89|0.53
72431451|NCT02478359|144374886|SUPERIORITY||Odds Ratio (OR)|1.03||||0.73|TWO_SIDED|95.0|0.88|1.2|||Regression, Logistic|||||1.20|0.88|0.73
72431452|NCT02478359|144374887|SUPERIORITY||Odds Ratio (OR)|1.13||||0.21|TWO_SIDED|95.0|0.93|1.37|||Regression, Logistic|||||1.37|0.93|0.21
72431453|NCT02478359|144374888|SUPERIORITY||Odds Ratio (OR)|1.1||||0.26|TWO_SIDED|95.0|0.93|1.31|||Regression, Logistic|||||1.31|0.93|0.26
72431454|NCT02478359|144374889|SUPERIORITY|||||||0.41|||||||t-test, 2 sided|||||||0.41
72431455|NCT02478359|144374890|SUPERIORITY|||||||0.55|||||||Regression, Linear|||||||0.55
72431456|NCT02478359|144374891|SUPERIORITY|||||||0.34||||||adjusted p values|Regression, Logistic|||Covariates included in the adjusted multivariate models were age, FEV1% predicted, Charlson comorbidity index, oxygen use, hospitalization for COPD in previous 12 months, outpatient treated COPD exacerbation in previous 12 months, length of time since acute care utilization to randomization, use of LABA or ICS, PA level and study site||||0.34
72431457|NCT02478359|144374892|SUPERIORITY|||||||0.6|||||||Regression, Linear|||||||0.60
72431458|NCT02478359|144374893|SUPERIORITY|||||||0.32|||||||Regression, Linear|||||||0.32
72431459|NCT02478359|144374894|SUPERIORITY|||||||0.47|||||||Regression, Linear|||||||0.47
72431460|NCT02478359|144374895|SUPERIORITY|||||||0.33|||||||Regression, Linear|||||||0.33
72431461|NCT02478359|144374896|SUPERIORITY|||||||0.87||||||Adjusted P value|Regression, Linear|||Covariates included in the adjusted multivariate models were age, FEV1% predicted, Charlson comorbidity index, oxygen use, hospitalization for COPD in previous 12 months, outpatient treated COPD exacerbation in previous 12 months, length of time since acute care utilization to randomization, use of LABA or ICS, PA level and study site||||0.87
72431462|NCT02478359|144374897|SUPERIORITY|||||||0.7||||||Adjusted P value|Regression, Linear|||Covariates included in the adjusted multivariate models were age, FEV1% predicted, Charlson comorbidity index, oxygen use, hospitalization for COPD in previous 12 months, outpatient treated COPD exacerbation in previous 12 months, length of time since acute care utilization to randomization, use of LABA or ICS, PA level and study site||||0.70
72431463|NCT02478359|144374898|SUPERIORITY|||||||0.35|||||||Regression, Linear|Adjusted P Values||Covariates included in the adjusted multivariate models were age, FEV1% predicted, Charlson comorbidity index, oxygen use, hospitalization for COPD in previous 12 months, outpatient treated COPD exacerbation in previous 12 months, length of time since acute care utilization to randomization, use of LABA or ICS, PA level and study site||||0.35
72431464|NCT02478359|144374899|SUPERIORITY|||||||0.09||||||Adjusted P Values|Regression, Linear|||Covariates included in the adjusted multivariate models were age, FEV1% predicted, Charlson comorbidity index, oxygen use, hospitalization for COPD in previous 12 months, outpatient treated COPD exacerbation in previous 12 months, length of time since acute care utilization to randomization, use of LABA or ICS, PA level and study site||||0.09
72431465|NCT02478359|144374900|SUPERIORITY|||||||0.82||||||Adjusted P Values|Regression, Linear|||Covariates included in the adjusted multivariate models were age, FEV1% predicted, Charlson comorbidity index, oxygen use, hospitalization for COPD in previous 12 months, outpatient treated COPD exacerbation in previous 12 months, length of time since acute care utilization to randomization, use of LABA or ICS, PA level and study site||||0.82
72431466|NCT02478359|144374901|SUPERIORITY|||||||0.16||||||Adjusted P values|Regression, Linear|||Covariates included in the adjusted multivariate models were age, FEV1% predicted, Charlson comorbidity index, oxygen use, hospitalization for COPD in previous 12 months, outpatient treated COPD exacerbation in previous 12 months, length of time since acute care utilization to randomization, use of LABA or ICS, PA level and study site||||0.16
72431467|NCT02478359|144374902|SUPERIORITY|||||||0.86||||||Adjusted P values|Regression, Linear|||Covariates included in the adjusted multivariate models were age, FEV1% predicted, Charlson comorbidity index, oxygen use, hospitalization for COPD in previous 12 months, outpatient treated COPD exacerbation in previous 12 months, length of time since acute care utilization to randomization, use of LABA or ICS, PA level and study site||||0.86
72431468|NCT02478359|144374903|SUPERIORITY|||||||0.57|||||||t-test, 2 sided|||||||0.57
72431469|NCT02478359|144374904|SUPERIORITY||Odds Ratio (OR)|1.05||||0.69|TWO_SIDED|95.0|0.82|1.35|||Regression, Logistic|||||1.35|0.82|0.69
72363984|NCT04672239|144239679|SUPERIORITY||Odds Ratio (OR)|1.5072||||0.2259|TWO_SIDED|95.0|0.7759|2.9281|||Generalized Linear Model|We used a Generalized Linear Model with binomial distribution (abstinent vs. smoking) and logit link with repeated measures over time.|The odds ratio compares the SiS app treatment to the QG app treatment at week 6 post-quit (end-of-treatment).|This was an exploratory aim, so no power analysis was conducted. We hypothesized, that the 30-day point prevalence smoking cessation prevalence would be higher in the SiS app treatment compared to the QuitGuide app treatment. Participants with missing data were assumed to be smoking. We modeled all available data over time and present the cross-sectional group difference test at week 6 post quit (i.e., end-of-treatment).||2.9281|0.7759|0.2259
72363985|NCT04672239|144239679|SUPERIORITY||Odds Ratio (OR)|1.963||||0.0579|TWO_SIDED|95.0|0.9776|3.9415|||Generalized Linear Model|We used a Generalized Linear Model with binomial distribution (abstinent vs. smoking) and logit link with repeated measures over time.|The odds ratio compares the SiS app treatment to the CtA pamphlet at week 6 post-quit (end-of-treatment).|This was an exploratory aim, so no power analysis was conducted. We hypothesized, that the 30-day point prevalence smoking cessation prevalence would be higher in the SiS app treatment compared to the Clearing the Air pamphlet treatment. Participants with missing data were assumed to be smoking. We modeled all available data over time and present the cross-sectional group difference test at week 6 post quit (i.e., post-treatment).||3.9415|0.9776|0.0579
72363986|NCT04672239|144239680|SUPERIORITY||Wilcoxon Z|0.401||||0.9152|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|Pairwise Two-Sided Multiple Comparison Analysis Dwass, Steel, Critchlow-Fligner Method|SiS app treatment vs. QuitGuide app treatment at week 6 post-quit (end-of-treatment)|||||0.9152
72363987|NCT04672239|144239680|SUPERIORITY||Wilcoxon Z|1.372||||0.3557|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|Pairwise Two-Sided Multiple Comparison Analysis Dwass, Steel, Critchlow-Fligner Method|Pairwise comparison, SiS app treatment vs. CTA pamphlet at week 6 post-quit (end-of-treatment)|||||0.3557
72363988|NCT04672239|144239681|SUPERIORITY||Mean Difference (Final Values)|0.2936||||0.7469|TWO_SIDED|95.0|-1.4983|2.0856||The p-value was not adjusted for multiple comparisons.|t-test, 2 sided||Comparison of SiS app treatment to the QuitGuide treatment as control (Contrast coding SiS 1, QG -1)|||2.0856|-1.4983|0.7469
72363989|NCT04672239|144239681|SUPERIORITY||Mean Difference (Final Values)|1.2569||||0.1747|TWO_SIDED|95.0|-0.5628|3.0766||The p-value was not adjusted for multiple comparisons.|t-test, 2 sided||Comparison of SiS app treatment to the Clearing the Air pamphlet treatment as control (Contrast coding SiS 1, CtA -1)|||3.0766|-0.5628|0.1747
72363990|NCT04672239|144239682|SUPERIORITY||Wilcoxon Z|1.9255||||0.1315|TWO_SIDED|||||p-values were not adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|Pairwise Two-Sided Multiple Comparison Analysis Dwass, Steel, Critchlow-Fligner Method||||||0.1315
72363991|NCT04672239|144239682|SUPERIORITY||Wilcoxon Z|1.401||||0.3403|TWO_SIDED|||||the p-value was not adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|Pairwise Two-Sided Multiple Comparison Analysis Dwass, Steel, Critchlow-Fligner Method|SiS app vs. Clearing the Air pamphlet|||||0.3403
72363992|NCT04672239|144239683|SUPERIORITY||Mean Difference (Final Values)|0.2289||||0.0429|TWO_SIDED|95.0|0.007364|0.4505||p-value is not adjusted for multiple comparisons|t-test, 2 sided||||SiS app vs. QuitGuide app|0.4505|0.007364|0.0429
72363993|NCT04672239|144239683|SUPERIORITY||Mean Difference (Final Values)|0.1609||||0.16|TWO_SIDED|95.0|-0.06415|0.386||p-value is not adjusted for multiple comparisons|t-test, 2 sided||||SiS app vs. CtA pamphlet|0.3860|-0.06415|0.1600
72363994|NCT04672239|144239684|SUPERIORITY||Mean Difference (Final Values)|0.152||||0.1996|TWO_SIDED|95.0|-0.08092|0.3848||p-value is not adjusted for multiple comparisons|t-test, 2 sided||||SiS app vs. QG app|0.3848|-0.08092|0.1996
72363995|NCT04672239|144239684|SUPERIORITY||Mean Difference (Final Values)|0.292||||0.0154|TWO_SIDED|95.0|0.05636|0.5276||p-value was not adjusted for multiple comparisons|t-test, 2 sided||||SiS app vs. CtA pamphlet (control)|0.5276|0.05636|0.0154
72363996|NCT04672239|144239685|SUPERIORITY||Mean Difference (Final Values)|2.6255||||0.2988|TWO_SIDED|95.0|-2.3458|7.5968||p-value was not adjusted for multiple comparisons|t-test, 2 sided||||SiS app vs. QuitGuide app (control)|7.5968|-2.3458|0.2988
72363997|NCT04672239|144239685|SUPERIORITY||Mean Difference (Final Values)|3.9277||||0.1251|TWO_SIDED|95.0|-1.1015|8.9569||p-value was not adjusted for multiple comparisons|t-test, 2 sided||||SiS app vs. CtA pamphlet (control)|8.9569|-1.1015|0.1251
72363998|NCT04672239|144239686|SUPERIORITY||Wilcoxon Z|-0.8096||||0.4182|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.4182
72363999|NCT04672239|144239687|SUPERIORITY||Wilcoxon Z|1.909||||0.0563|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.0563
72364000|NCT04672239|144239688|SUPERIORITY||Mean Difference (Final Values)|0.1106||||0.5018|TWO_SIDED|95.0|-0.2143|0.4354|||t-test, 2 sided|||||0.4354|-0.2143|0.5018
72364001|NCT04672239|144239689|SUPERIORITY||Mean Difference (Final Values)|0.1406||||0.4246|TWO_SIDED|95.0|-0.2068|0.488|||t-test, 2 sided|||||0.4880|-0.2068|0.4246
72364002|NCT04672239|144239690|SUPERIORITY||Mean Difference (Final Values)|2.4296||||0.4078|TWO_SIDED|95.0|-3.3597|8.2188|||t-test, 2 sided||SiS app vs. QG (control)|||8.2188|-3.3597|0.4078
72364003|NCT03373240|144239710|OTHER|Examining stop signal reaction time changed across the 4-week training period|Mean Difference (Net)|-8.62|STANDARD_ERROR_OF_MEAN|2.79||0.003|TWO_SIDED|95.0|-14.17|-3.06|||Mixed Models Analysis|||||-3.06|-14.17|.003
72364004|NCT03373240|144239711|SUPERIORITY||Mean Difference (Net)|-0.075|STANDARD_ERROR_OF_MEAN|0.127||0.049|TWO_SIDED|95.0|-0.333|0.184|||ANOVA|||||.184|-.333|.049
72364005|NCT03373240|144239712|SUPERIORITY||Mean Difference (Net)|-1.914|STANDARD_ERROR_OF_MEAN|1.011||0.236|TWO_SIDED|95.0|-3.965|0.136|||ANOVA|||||.136|-3.965|.236
72364006|NCT03373240|144239713|OTHER|Examining whether percentage of risky choices decreased across the 4-wwek training period.|Mean Difference (Net)|-1.62|STANDARD_ERROR_OF_MEAN|0.77||0.039|TWO_SIDED|95.0|-3.15|-0.08|||Mixed Models Analysis|||||-.08|-3.15|.039
72364007|NCT03373240|144239714|OTHER||Mean Difference (Net)|-1.77|STANDARD_ERROR_OF_MEAN|0.82||0.035|TWO_SIDED|95.0|-3.4|-0.13|||Mixed Models Analysis|||||-.13|-3.40|.035
72364008|NCT03373240|144239715|OTHER||Mean Difference (Net)|4.26|STANDARD_ERROR_OF_MEAN|0.57|<|0.001|TWO_SIDED|95.0|3.12|5.39|||Mixed Models Analysis|||||5.39|3.12|<.001
72364009|NCT03373240|144239716|SUPERIORITY||Mean Difference (Net)|0.933|STANDARD_ERROR_OF_MEAN|0.403||0.008|TWO_SIDED|95.0|0.111|1.755|||ANOVA|||||1.755|.111|.008
72364010|NCT03373240|144239717|SUPERIORITY||Mean Difference (Net)|0.019|STANDARD_ERROR_OF_MEAN|0.096||0.077|TWO_SIDED|97.0|-0.177|0.214|||ANOVA|||||.214|-.177|.077
72364011|NCT03373240|144239718|SUPERIORITY||Mean Difference (Net)|-0.964|STANDARD_ERROR_OF_MEAN|1.902||0.547|TWO_SIDED|95.0|-4.822|2.895|||ANOVA|||||2.895|-4.822|.547
72364012|NCT03373240|144239719|SUPERIORITY||Mean Difference (Net)|-0.532|STANDARD_ERROR_OF_MEAN|0.628||0.436|TWO_SIDED|95.0|-1.805|0.742|||ANOVA|||||.742|-1.805|.436
72364013|NCT04825678|144239745|OTHER||Least squares mean (LSM)|40.72|STANDARD_ERROR_OF_MEAN|2.37|<|0.001|TWO_SIDED|95.0|36.05|45.39||P-value is nominal to compare the mean change from Baseline at Week 24 to zero.|Mixed Models Analysis|||Adjusted analysis utilizes a generalized linear mixed model which includes Baseline TSQM overall satisfaction scale score, visit, the prevailing erenumab dose from Week 12 onwards, observed Baseline monthly migraine days (MMD), and selected Baseline characteristics as covariates and assumes a first-order auto regression covariance structure.||45.39|36.05|< 0.001
72364014|NCT04825678|144239745|OTHER||LSM|30.84|STANDARD_ERROR_OF_MEAN|14.53||0.058|TWO_SIDED|95.0|-1.3|62.98||P-value is nominal to compare the mean change from Baseline at Week 24 to zero.|Mixed Models Analysis|||Adjusted analysis utilizes a generalized linear mixed model which includes Baseline TSQM overall satisfaction scale score, visit, the prevailing erenumab dose from Week 12 onwards, observed Baseline MMD, and selected Baseline characteristics as covariates and assumes a first-order auto regression covariance structure.||62.98|-1.30|0.058
72364015|NCT04825678|144239746|OTHER||LSM|37.87|STANDARD_ERROR_OF_MEAN|4.62|<|0.001|TWO_SIDED|95.0|28.62|47.12||P-value is nominal to compare the mean change from Baseline at Week 24 to zero.|Mixed Models Analysis|||Adjusted analysis utilizes a generalized linear mixed model which includes Baseline TSQM overall satisfaction scale score, visit, the prevailing erenumab dose from Week 12 onwards, observed Baseline MMD, and selected Baseline characteristics as covariates and assumes a first-order auto regression covariance structure.||47.12|28.62|< 0.001
72364016|NCT04825678|144239746|OTHER||LSM|43.25|STANDARD_ERROR_OF_MEAN|2.63|<|0.001|TWO_SIDED|95.0|38.06|48.44||P-value is nominal to compare the mean change from Baseline at Week 24 to zero.|Mixed Models Analysis|||Adjusted analysis utilizes a generalized linear mixed model which includes Baseline TSQM overall satisfaction scale score, visit, the prevailing erenumab dose from Week 12 onwards, observed Baseline MMD, and selected Baseline characteristics as covariates and assumes a first-order auto regression covariance structure.||48.44|38.06|< 0.001
72364017|NCT04825678|144239755|OTHER|Adjusted analysis utilizes a generalized linear mixed model which includes Baseline function domain score, visit, the prevailing erenumab dose from Week 12 onwards, observed Baseline MMD, and selected Baseline characteristics as covariates and assumes a first-order auto regression covariance structure.|LSM|-44.9|STANDARD_ERROR_OF_MEAN|2.28|<|0.001|TWO_SIDED|95.0|-49.39|-40.41||P-value is nominal to compare the mean change from Baseline at Week 24 to zero.|Mixed Models Analysis|||Continued SoC: Physical Function Domain||-40.41|-49.39|< 0.001
72364018|NCT04825678|144239755|OTHER|Adjusted analysis utilizes a generalized linear mixed model which includes Baseline function domain score, visit, the prevailing erenumab dose from Week 12 onwards, observed Baseline MMD, and selected Baseline characteristics as covariates and assumes a first-order auto regression covariance structure.|LSM|-54.15|STANDARD_ERROR_OF_MEAN|8.43|<|0.001|TWO_SIDED|95.0|-73.43|-34.86||P-value is nominal to compare the mean change from Baseline at Week 24 to zero.|Mixed Models Analysis|||Discontinued SoC: Physical Function Domain||-34.86|-73.43|< 0.001
72364019|NCT04825678|144239755|OTHER|Adjusted analysis utilizes a generalized linear mixed model which includes baseline function domain score, visit, the prevailing erenumab dose from Week 12 onwards, observed baseline MMD, and selected baseline characteristics as covariates and assumes a first-order auto regression covariance structure.|LSM|-44.35|STANDARD_ERROR_OF_MEAN|1.99|<|0.001|TWO_SIDED|95.0|-48.26|-40.44||P-value is nominal to compare the mean change from baseline at Week 24 to zero.|Mixed Models Analysis|||Continued SoC: Usual Activities Domain||-40.44|-48.26|< 0.001
72364020|NCT04825678|144239755|OTHER|Adjusted analysis utilizes a generalized linear mixed model which includes Baseline function domain score, visit, the prevailing erenumab dose from Week 12 onwards, observed Baseline MMD, and selected Baseline characteristics as covariates and assumes a first-order auto regression covariance structure.|LSM|-43.8|STANDARD_ERROR_OF_MEAN|4.47|<|0.001|TWO_SIDED|95.0|-53.51|-34.08||P-value is nominal to compare the mean change from Baseline at Week 24 to zero.|Mixed Models Analysis|||Discontinued SoC: Usual Activities Domain||-34.08|-53.51|< 0.001
72364021|NCT04825678|144239755|OTHER|Adjusted analysis utilizes a generalized linear mixed model which includes Baseline function domain score, visit, the prevailing erenumab dose from Week 12 onwards, observed Baseline MMD, and selected Baseline characteristics as covariates and assumes a first-order auto regression covariance structure.|LSM|-44.39|STANDARD_ERROR_OF_MEAN|2.16|<|0.001|TWO_SIDED|95.0|-48.65|-40.14||P-value is nominal to compare the mean change from Baseline at Week 24 to zero.|Mixed Models Analysis|||Continued SoC: Social Function Domain||-40.14|-48.65|< 0.001
72364022|NCT04825678|144239755|OTHER|Adjusted analysis utilizes a generalized linear mixed model which includes Baseline function domain score, visit, the prevailing erenumab dose from Week 12 onwards, observed Baseline MMD, and selected Baseline characteristics as covariates and assumes a first-order auto regression covariance structure.|LSM|-45.03|STANDARD_ERROR_OF_MEAN|6.97|<|0.001|TWO_SIDED|95.0|-60.28|-29.79||P-value is nominal to compare the mean change from Baseline at Week 24 to zero.|Mixed Models Analysis|||Discontinued SoC: Social Function Domain||-29.79|-60.28|< 0.001
72364023|NCT04825678|144239755|OTHER|Adjusted analysis utilizes a generalized linear mixed model which includes Baseline function domain score, visit, the prevailing erenumab dose from Week 12 onwards, observed Baseline MMD, and selected Baseline characteristics as covariates and assumes a first-order auto regression covariance structure.|LSM|-45.5|STANDARD_ERROR_OF_MEAN|2.44|<|0.001|TWO_SIDED|95.0|-50.29|-40.7||P-value is nominal to compare the mean change from Baseline at Week 24 to zero.|Mixed Models Analysis|||Continued SoC: Emotional Function Domain||-40.70|-50.29|< 0.001
72364024|NCT04825678|144239755|OTHER|Adjusted analysis utilizes a generalized linear mixed model which includes Baseline function domain score, visit, the prevailing erenumab dose from Week 12 onwards, observed Baseline MMD, and selected Baseline characteristics as covariates and assumes a first-order auto regression covariance structure.|LSM|-60.06|STANDARD_ERROR_OF_MEAN|10.98|<|0.001|TWO_SIDED|95.0|-85.16|-34.96||P-value is nominal to compare the mean change from Baseline at Week 24 to zero.|Mixed Models Analysis|||Discontinued SoC: Emotional Function Domain||-34.96|-85.16|< 0.001
72431470|NCT02478359|144374905|SUPERIORITY||Odds Ratio (OR)|0.62||||0.11|TWO_SIDED|95.0|0.35|1.11|||Regression, Logistic|||||1.11|0.35|0.11
72431471|NCT02478359|144374906|SUPERIORITY||Odds Ratio (OR)|0.84||||0.21|TWO_SIDED|95.0|0.65|1.1|||Regression, Logistic|||||1.10|0.65|0.21
72431472|NCT02478359|144374907|SUPERIORITY||Odds Ratio (OR)|1.07||||0.6|TWO_SIDED|95.0|0.84|1.36|||Regression, Logistic|||||1.36|0.84|0.60
72364025|NCT04825678|144239756|OTHER|Adjusted analysis utilizes a generalized linear mixed model which includes Baseline function domain score, visit, the prevailing erenumab dose from Week 12 onwards, observed Baseline MMD, and selected Baseline characteristics as covariates and assumes a first-order auto regression covariance structure.|LSM|-34.38|STANDARD_ERROR_OF_MEAN|3.69|<|0.001|TWO_SIDED|95.0|-41.72|-27.03||P-value is nominal to compare the mean change from Baseline at Week 24 to zero.|Mixed Models Analysis|||EM: Physical Function Domain||-27.03|-41.72|< 0.001
72364026|NCT04825678|144239756|OTHER|Adjusted analysis utilizes a generalized linear mixed model which includes Baseline function domain score, visit, the prevailing erenumab dose from Week 12 onwards, observed Baseline MMD, and selected Baseline characteristics as covariates and assumes a first-order auto regression covariance structure.|LSM|-49.56|STANDARD_ERROR_OF_MEAN|2.48|<|0.001|TWO_SIDED|95.0|-54.44|-44.69||P-value is nominal to compare the mean change from Baseline at Week 24 to zero.|Mixed Models Analysis|||CM: Physical Function Domain||-44.69|-54.44|< 0.001
72364027|NCT04825678|144239756|OTHER|Adjusted analysis utilizes a generalized linear mixed model which includes baseline function domain score, visit, the prevailing erenumab dose from Week 12 onwards, observed baseline MMD, and selected baseline characteristics as covariates and assumes a first-order auto regression covariance structure.|LSM|-35.76|STANDARD_ERROR_OF_MEAN|2.88|<|0.001|TWO_SIDED|95.0|-41.47|-30.06||P-value is nominal to compare the mean change from baseline at Week 24 to zero.|Mixed Models Analysis|||EM: Usual Activities Domain||-30.06|-41.47|< 0.001
72364028|NCT04825678|144239756|OTHER|Adjusted analysis utilizes a generalized linear mixed model which includes Baseline function domain score, visit, the prevailing erenumab dose from Week 12 onwards, observed Baseline MMD, and selected Baseline characteristics as covariates and assumes a first-order auto regression covariance structure.|LSM|-46.7|STANDARD_ERROR_OF_MEAN|2.23|<|0.001|TWO_SIDED|95.0|-51.1|-42.29||P-value is nominal to compare the mean change from Baseline at Week 24 to zero.|Mixed Models Analysis|||CM: Usual Activities Domain||-42.29|-51.10|< 0.001
72364029|NCT04825678|144239756|OTHER|Adjusted analysis utilizes a generalized linear mixed model which includes Baseline function domain score, visit, the prevailing erenumab dose from Week 12 onwards, observed Baseline MMD, and selected Baseline characteristics as covariates and assumes a first-order auto regression covariance structure.|LSM|-36.42|STANDARD_ERROR_OF_MEAN|3.26|<|0.001|TWO_SIDED|95.0|-42.89|-29.96||P-value is nominal to compare the mean change from Baseline at Week 24 to zero.|Mixed Models Analysis|||EM: Social Function Domain||-29.96|-42.89|< 0.001
72364030|NCT04825678|144239756|OTHER|Adjusted analysis utilizes a generalized linear mixed model which includes Baseline function domain score, visit, the prevailing erenumab dose from Week 12 onwards, observed Baseline MMD, and selected Baseline characteristics as covariates and assumes a first-order auto regression covariance structure.|LSM|-46.73|STANDARD_ERROR_OF_MEAN|2.41|<|0.001|TWO_SIDED|95.0|-51.49|-41.98||P-value is nominal to compare the mean change from Baseline at Week 24 to zero.|Mixed Models Analysis|||CM: Social Function Domain||-41.98|-51.49|< 0.001
72364031|NCT04825678|144239756|OTHER|Adjusted analysis utilizes a generalized linear mixed model which includes Baseline function domain score, visit, the prevailing erenumab dose from Week 12 onwards, observed Baseline MMD, and selected Baseline characteristics as covariates and assumes a first-order auto regression covariance structure.|LSM|-41.44|STANDARD_ERROR_OF_MEAN|4.04|<|0.001|TWO_SIDED|95.0|-49.47|-33.4||P-value is nominal to compare the mean change from Baseline at Week 24 to zero.|Mixed Models Analysis|||EM: Emotional Function Domain||-33.40|-49.47|< 0.001
72364032|NCT04825678|144239756|OTHER|Adjusted analysis utilizes a generalized linear mixed model which includes Baseline function domain score, visit, the prevailing erenumab dose from Week 12 onwards, observed Baseline MMD, and selected Baseline characteristics as covariates and assumes a first-order auto regression covariance structure.|LSM|-47.67|STANDARD_ERROR_OF_MEAN|2.68|<|0.001|TWO_SIDED|95.0|-52.95|-42.39||P-value is nominal to compare the mean change from Baseline at Week 24 to zero.|Mixed Models Analysis|||CM: Emotional Function Domain||-42.39|-52.95|< 0.001
72364033|NCT02086175|144239764|SUPERIORITY||percent|48.0||||0.044|TWO_SIDED|90.0|31.0|66.0|||Fisher Exact|||"Patients will be accrued in a single stage design, with a goal accrual of 25 patients.~Assuming a 30% response rate with rituximab alone, if the true but unknown rate of CR or PR is 50% with the addition of Imprime PGG, the probability of observing 11 or more patients with a response is 0.79 with 0.098 one-sided type-I error.~Therefore a study with 25 patients, in which an observed response rate of 11/25 (44%) would be considered worthy of further consideration."||66|31|0.044
72364034|NCT04328077|144239775|SUPERIORITY||Mean Difference (Final Values)|2.7|STANDARD_ERROR_OF_MEAN|9.44||0.7755|TWO_SIDED|95.0|-16.1|21.5|||ANCOVA|||||21.5|-16.1|0.7755
72364035|NCT04328077|144239775|SUPERIORITY||Mean Difference (Final Values)|-12.66|STANDARD_ERROR_OF_MEAN|9.369||0.1798|TWO_SIDED|95.0|-31.3|5.9|||ANCOVA|||||5.9|-31.3|0.1798
72364036|NCT04328077|144239775|SUPERIORITY||Mean Difference (Final Values)|-7.9|STANDARD_ERROR_OF_MEAN|9.807||0.4229|TWO_SIDED|95.0|-27.4|11.6|||ANCOVA|||||11.6|-27.4|0.4229
72364037|NCT00744497|144239780|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.99||||0.9009|TWO_SIDED|95.53|0.87|1.13||An interim analysis on survival was performed and the final test was corrected for multiplicity.|Log Rank|||Confidence intervals for median overall survival calculated using Brookmeyer and Crowley method. Compared survival in arms by 2-sided, alpha=0.0447 level, log-rank test, stratified by bisphosphonate intake (yes/no) and urinary N-telopeptide category (\<60 vs ≥60 nmol/mmol creatinine) defined at randomization. Null hypothesis was survival equal in both arms. Power calculations were that ≥858 deaths would lead to ≥90% power at 5% level for rejecting null hypothesis, given true hazard ratio of 0.8.||1.13|0.87|0.9009
72364038|NCT00744497|144239781|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.935|||||TWO_SIDED|95.0|0.688|1.271||||||Since superiority of the dasatinib treatment group was not demonstrated for Overall Survival, secondary endpoints were not tested. The odds ratio is presented for experimental to control group.||1.271|0.688|
72364039|NCT00744497|144239782|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.81|||||TWO_SIDED|95.0|0.64|1.02||||||Since superiority of the dasatinib treatment group was not demonstrated for Overall Survival, secondary endpoints were not tested. The hazard ratio is presented for experimental to control group.||1.02|0.64|
72431473|NCT02478359|144374908|SUPERIORITY||Odds Ratio (OR)|0.92||||0.63|TWO_SIDED|95.0|0.66|1.28|||Regression, Logistic|||||1.28|0.66|0.63
72431474|NCT02478359|144374909|SUPERIORITY||Odds Ratio (OR)|0.96||||0.8|TWO_SIDED|95.0|0.68|1.35|||Regression, Logistic|||||1.35|0.68|0.80
72431475|NCT02478359|144374910|SUPERIORITY|||||||0.06||||||Adjusted P value|Regression, Linear|||Covariates included in the as-treated adjusted linear regression analyses were age, FEV1%predicted, Charlson comorbidity index, oxygen use, hospitalization for COPD in previous 12 months, outpatient treated COPD exacerbation in previous 12 months, length of time since acute care utilization to randomization, use of LABA or ICS, PA level, and study site||||0.06
72431476|NCT02478359|144374911|SUPERIORITY|||||||0.07||||||Adjusted P value|Regression, Linear|||Covariates included in the as-treated adjusted linear regression analyses were age, FEV1%predicted, Charlson comorbidity index, oxygen use, hospitalization for COPD in previous 12 months, outpatient treated COPD exacerbation in previous 12 months, length of time since acute care utilization to randomization, use of LABA or ICS, PA level, and study site||||0.07
72431477|NCT02478359|144374912|SUPERIORITY|||||||0.67||||||Adjusted P value|Regression, Linear|||Covariates included in the as-treated adjusted linear regression analyses were FEV1%predicted, Charlson comorbidity index, oxygen use, hospitalization for COPD in previous 12 months, outpatient treated COPD exacerbation in previous 12 months, length of time since acute care utilization to randomization, use of LABA or ICS, PA level, and study site||||0.67
72431478|NCT02478359|144374913|SUPERIORITY|||||||0.13||||||Adjusted P value|Regression, Linear|||Covariates included in the as-treated adjusted linear regression analyses were age, FEV1%predicted, Charlson comorbidity index, oxygen use, hospitalization for COPD in previous 12 months, outpatient treated COPD exacerbation in previous 12 months, length of time since acute care utilization to randomization, use of LABA or ICS, PA level, and study site||||0.13
72431479|NCT02478359|144374914|SUPERIORITY|||||||0.34||||||Adjusted P value|Regression, Linear|||Covariates included in the as-treated adjusted linear regression analyses were age, FEV1%predicted, Charlson comorbidity index, oxygen use, hospitalization for COPD in previous 12 months, outpatient treated COPD exacerbation in previous 12 months, length of time since acute care utilization to randomization, use of LABA or ICS, PA level, and study site||||0.34
72431480|NCT02478359|144374915|SUPERIORITY|||||||0.11||||||Adjusted P value|Regression, Linear|||Covariates included in the as-treated adjusted linear regression analyses were age, FEV1%predicted, Charlson comorbidity index, oxygen use, hospitalization for COPD in previous 12 months, outpatient treated COPD exacerbation in previous 12 months, length of time since acute care utilization to randomization, use of LABA or ICS, PA level, and study site||||0.11
72431481|NCT02478359|144374916|SUPERIORITY|||||||0.83||||||Adjusted P value|Regression, Linear|||Covariated included in the as-treated adjusted linear regression analyses were age, FEV1%predicted, Charlson comorbidity index, oxygen use, hospitalization for COPD in previous 12 months, outpatient treated COPD exacerbation in previous 12 months, length of time since acute care utilization to randomization, use of LABA or ICS, PA level, and study site||||0.83
72431482|NCT00755755|144374919|SUPERIORITY_OR_OTHER||Difference in proportions|72.7|||<|0.001|TWO_SIDED|95.0|55.1|83.2||As comparison involved two doses of PGL4001 vs Placebo, Bonferroni correction used with p-values doubled (threshold was 0.05) and confidence intervals adjusted|Cochran-Mantel-Haenszel|Adjustment for randomization strata|Confidence intervals with the use of Newcombe-Wilson score method (uncorrected)|||83.2|55.1|<0.001
72431483|NCT00755755|144374919|SUPERIORITY_OR_OTHER||Difference in proportions|73.7|||<|0.001|TWO_SIDED|95.0|56.2|84.0||As comparison involved two doses of PGL4001 vs Placebo, Bonferroni correction used with p values doubled (threshold was 0.05) and confidence intervals adjusted|Cochran-Mantel-Haenszel|Adjustment for randomization strata|Confidence intervals with the use of Newcombe-Wilson score method (uncorrected)|||84.0|56.2|<0.001
72431484|NCT00755755|144374920|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-22.6||||0.002|TWO_SIDED|95.0|-36.1|-8.2||As comparison involved two doses of PGL4001 vs Placebo, Bonferroni correction used with p-values doubled (threshold was 0.05) and confidence intervals adjusted.|Wilcoxon (Mann-Whitney)|Use of the Van Elteren extension to the Wilcoxon rank-sum test with adjustment for randomization strata|Hodges-Lehmann point estimator with corresponding Moses confidence interval.|||-8.2|-36.1|0.002
72431485|NCT00755755|144374920|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-18.2||||0.006|TWO_SIDED|95.0|-33.0|-5.2||As comparison involved two doses of PGL4001 vs Placebo, Bonferroni correction used with p values doubled (threshold was 0.05) and confidence intervals adjusted.|Wilcoxon (Mann-Whitney)|Use of the Van Elteren extension to the Wilcoxon rank-sum test with adjustment for randomization strata|Hodges-Lehmann point estimator with corresponding Moses confidence interval.|||-5.2|-33.0|0.006
72431486|NCT00083174|144374922|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.35||||0.002|TWO_SIDED|95.0|0.18|0.7|||Log Rank|||The null hypothesis was no difference between two groups. The sample size estimate was based on an assumption of annual invasive breast cancer rate of 0.60% in the placebo group and 0.21% in exemestane group, a relative reduction of 65% with exemestane. To detect this with a two-sided 5% level and 90% power, a total of 38 cases of invasive breast cancer were required, projected to occur when 4560 women were randomly assigned in a 3-year period and then followed for an additional 1.2 years.||0.70|0.18|0.002
72431487|NCT00083174|144374923|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.47||||0.004|TWO_SIDED|95.0|0.27|0.79|||Log Rank|||||0.79|0.27|0.004
72431488|NCT00083174|144374924|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.36||||0.07|TWO_SIDED|95.0|0.11|1.12|||Log Rank|||||1.12|0.11|0.07
72431489|NCT02084082|144374956|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratios of the geometric means (FDC/free combination) using an acceptance range of 80.00 to 125.00%.|Adjusted Geometric Means ratio|100.37|STANDARD_ERROR_OF_MEAN|1.023|<|0.0001|TWO_SIDED|90.0|96.562|104.326|||ANOVA|ANOVA on the logarithmic scale including effects for 'sequence', 'subjects within sequences', 'period', and 'treatment'.|Ratio of (FDC 1000\_fasted/ L+M 1000 fasted)|||104.326|96.562|<0.0001
72431490|NCT02084082|144374956|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratios of the geometric means (FDC/free combination) using an acceptance range of 80.00 to 125.00%.|Geometric mean ratio (net)|94.7|STANDARD_ERROR_OF_MEAN|1.037||0.0004|TWO_SIDED|90.0|88.712|101.089|||ANOVA|ANOVA on the logarithmic scale including effects for 'sequence', 'subjects within sequences', 'period', and 'treatment'.|Ratio of (FDC 1000 Fed/ L+M 1000 Fed)|||101.089|88.712|0.0004
72431491|NCT02084082|144374957|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratios of the geometric means (FDC/free combination) using an acceptance range of 80.00 to 125.00%.|Adjusted Geometric Mean ratio|108.09|STANDARD_ERROR_OF_MEAN|1.054||0.0038|TWO_SIDED|90.0|99.022|117.989|||ANOVA|ANOVA on the logarithmic scale including effects for 'sequence', 'subjects within sequences', 'period', and 'treatment'.|Ratio of (FDC 1000\_fasted/ L+M 1000 fasted)|||117.989|99.022|0.0038
72431492|NCT02084082|144374957|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratios of the geometric means (FDC/free combination) using an acceptance range of 80.00 to 125.00%.|Adjusted Geometric Means ratio|98.24|STANDARD_ERROR_OF_MEAN|1.024|<|0.0001|TWO_SIDED|90.0|94.067|102.597|||ANOVA|ANOVA on the logarithmic scale including effects for 'sequence', 'subjects within sequences', 'period', and 'treatment'.|Ratio of (FDC 1000\_fed / L+M 1000 fed)|||102.597|94.067|<0.0001
72431493|NCT02084082|144374958|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratios of the geometric means (FDC/free combination) using an acceptance range of 80.00 to 125.00%.|Adjusted Geometric Mean ratio|99.99|STANDARD_ERROR_OF_MEAN|1.04|<|0.0001|TWO_SIDED|90.0|93.03|107.47|||ANOVA|ANOVA on the logarithmic scale including effects for 'sequence', 'subjects within sequences', 'period', and 'treatment'.|Ratio of (FDC 1000\_fasted/ L+M 1000 fasted)|||107.47|93.03|<0.0001
72431494|NCT02084082|144374958|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratios of the geometric means (FDC/free combination) using an acceptance range of 80.00 to 125.00%.|Adjusted Geometric Means ratio|96.95|STANDARD_ERROR_OF_MEAN|1.03|<|0.0001|TWO_SIDED|90.0|92.24|101.89|||ANOVA|ANOVA on the logarithmic scale including effects for 'sequence', 'subjects within sequences', 'period', and 'treatment'.|Ratio of (FDC 1000\_fed / L+M 1000 fed)|||101.89|92.24|<0.0001
72431495|NCT02084082|144374959|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratios of the geometric means (FDC/free combination) using an acceptance range of 80.00 to 125.00%.|Adjusted Geometric Means ratio|99.77|STANDARD_ERROR_OF_MEAN|1.046|<|0.0001|TWO_SIDED|90.0|92.464|107.645|||ANOVA|ANOVA on the logarithmic scale including effects for 'sequence', 'subjects within sequences', 'period', and 'treatment'.|Ratio of (FDC 1000\_fasted/ L+M 1000 fasted)|||107.645|92.464|<0.0001
72431496|NCT02084082|144374959|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratios of the geometric means (FDC/free combination) using an acceptance range of 80.00 to 125.00%.|Adjusted Geometric Means ratio|98.97|STANDARD_ERROR_OF_MEAN|1.023|<|0.0001|TWO_SIDED|90.0|94.95|103.16|||ANOVA|ANOVA on the logarithmic scale including effects for 'sequence', 'subjects within sequences', 'period', and 'treatment'.|Ratio of (FDC 1000\_fed / L+M 1000 fed)|||103.160|94.950|<0.0001
72431497|NCT02084082|144374960|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratios of the geometric means (FDC/free combination) using an acceptance range of 80.00 to 125.00%.|Adjusted Geometric Means ratio|99.72|STANDARD_ERROR_OF_MEAN|1.028|<|0.0001|TWO_SIDED|90.0|95.163|104.493|||ANOVA|ANOVA on the logarithmic scale including effects for 'sequence', 'subjects within sequences', 'period', and 'treatment'.|Ratio of (FDC 1000\_fasted/ L+M 1000 fasted)|||104.493|95.163|<0.0001
72431498|NCT02084082|144374960|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratios of the geometric means (FDC/free combination) using an acceptance range of 80.00 to 125.00%.|Adjusted Geometric Means ratio|97.36|STANDARD_ERROR_OF_MEAN|1.132||0.0778|TWO_SIDED|90.0|77.082|122.963|||ANOVA|ANOVA on the logarithmic scale including effects for 'sequence', 'subjects within sequences', 'period', and 'treatment'.|Ratio of (FDC 1000\_fed / L+M 1000 fed)|||122.963|77.082|0.0778
72431499|NCT02084082|144374961|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratios of the geometric means (FDC/free combination) using an acceptance range of 80.00 to 125.00%.|Adjusted Geometric Means ratio|99.11|STANDARD_ERROR_OF_MEAN|1.04|<|0.0001|TWO_SIDED|90.0|92.37|106.35|||ANOVA|ANOVA on the logarithmic scale including effects for 'sequence', 'subjects within sequences', 'period', and 'treatment'.|Ratio of (FDC 1000\_fasted/ L+M 1000 fasted)|||106.35|92.37|<0.0001
72431500|NCT02084082|144374961|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratios of the geometric means (FDC/free combination) using an acceptance range of 80.00 to 125.00%.|Adjusted Geometric Means ratio|98.18|STANDARD_ERROR_OF_MEAN|1.03|<|0.0001|TWO_SIDED|90.0|93.34|103.27|||ANOVA|ANOVA on the logarithmic scale including effects for 'sequence', 'subjects within sequences', 'period', and 'treatment'.|Ratio of (FDC 1000\_fed / L+M 1000 fed)|||103.27|93.34|<0.0001
72431501|NCT04736056|144374966|OTHER||Cohen's d effect size|1.2|||||TWO_SIDED|95.0|0.73|1.66||||||0 to 12 weeks||1.66|0.73|
72431502|NCT04736056|144374966|OTHER||Cohen's d effect size|1.07|||||TWO_SIDED|95.0|0.61|1.51||||||0 to 16 weeks||1.51|0.61|
72431503|NCT04736056|144374967|OTHER||Cohen's d effect size|0.35|||||TWO_SIDED|95.0|-0.02|0.71||||||0 to 12 weeks||0.71|-0.02|
72431504|NCT04736056|144374967|OTHER||Cohen's d effect size|0.25|||||TWO_SIDED|95.0|-0.12|0.61||||||0 to 16 weeks||0.61|-0.12|
72431505|NCT04736056|144374968|OTHER||Cohen's d effect size|0.78|||||TWO_SIDED|95.0|0.38|1.18||||||0 to 12 weeks||1.18|0.38|
72431506|NCT04736056|144374968|OTHER||Cohen's d effect size|0.5|||||TWO_SIDED|95.0|0.11|0.87||||||0 to 16 weeks||0.87|0.11|
72431507|NCT04736056|144374969|OTHER||Cohen's d effect size|0.23|||||TWO_SIDED|95.0|-0.13|0.58||||||0 to 12 weeks||0.58|-0.13|
72431508|NCT04736056|144374969|OTHER||Cohen's d effect size|0.31|||||TWO_SIDED|95.0|-0.05|0.68||||||0 to 16 weeks||0.68|-0.05|
72431509|NCT04736056|144374970|OTHER||Cohen's d effect size|0.32|||||TWO_SIDED|95.0|-0.04|0.68||||||0 to 12 weeks||0.68|-0.04|
72431510|NCT04736056|144374970|OTHER||Cohen's d effect size|0.61|||||TWO_SIDED|95.0|0.22|1.0||||||0 to 16 weeks||1.00|0.22|
72431511|NCT04736056|144374971|OTHER||Cohen's d effect size|0.38|||||TWO_SIDED|95.0|0.01|0.74||||||0 to 12 weeks||0.74|0.01|
72431512|NCT04736056|144374971|OTHER||Cohen's d effect size|0.47|||||TWO_SIDED|95.0|0.09|0.85||||||0 to 16 weeks||0.85|0.09|
72431513|NCT04736056|144374972|OTHER||Cohen's d effect size|0.29|||||TWO_SIDED|95.0|-0.07|0.65||||||0 to 12 weeks||0.65|-0.07|
72431514|NCT04736056|144374972|OTHER||Cohen's d effect size|0.6|||||TWO_SIDED|95.0|0.21|0.99||||||||0.99|0.21|
72431515|NCT04736056|144374973|OTHER||Cohen's d effect size|0.54|||||TWO_SIDED|95.0|0.16|0.91||||||0 to 12 weeks||0.91|0.16|
72431516|NCT04736056|144374973|OTHER||Cohen's d effect size|0.51|||||TWO_SIDED|95.0|0.12|0.89||||||0 to 16 weeks||0.89|0.12|
72364040|NCT00744497|144239783|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.28|||||TWO_SIDED|95.0|0.93|1.763||||||Since superiority of the dasatinib treatment group was not demonstrated for Overall Survival, secondary endpoints were not tested. The odds ratio is presented for experimental to control group.||1.763|0.930|
72364041|NCT00744497|144239784|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.92|||||TWO_SIDED|95.0|0.82|1.05||||||Since superiority of the dasatinib treatment group was not demonstrated for Overall Survival, secondary endpoints were not tested. The hazard ratio is presented for experimental to control group.||1.05|0.82|
72364042|NCT00744497|144239785|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.89|||||TWO_SIDED|95.0|0.79|1.01||||||Since superiority of the dasatinib treatment group was not demonstrated for Overall Survival, secondary endpoints were not tested. The hazard ratio is presented for experimental to control group.||1.01|0.79|
72364043|NCT00744497|144239786|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.791|||||TWO_SIDED|95.0|0.594|1.052||||||Since superiority of the dasatinib treatment group was not demonstrated for Overall Survival, secondary endpoints were not tested. The odds ratio is presented for of experimental to control group.||1.052|0.594|
72364044|NCT01116986|144239795|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.954||||0.312|TWO_SIDED|95.0|0.871|1.045|||Regression, Cox|||The Cox regression model effects consisted of six treatment effects, 15 two-way treatment interactions, and three covariates : gender and two items from the Fagerstrom Test of Nicotine Dependence (Item 1: time to first cigarette; Item 4: cigarettes per day).||1.045|.871|.312
72364045|NCT01116986|144239795|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.98||||0.664|TWO_SIDED|95.0|0.894|1.074|||Regression, Cox|||The Cox regression model effects consisted of six treatment effects, 15 two-way treatment interactions, and three covariates : gender and two items from the Fagerstrom Test of Nicotine Dependence (Item 1: time to first cigarette; Item 4: cigarettes per day).||1.074|.894|.664
72364046|NCT01116986|144239795|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.989||||0.814|TWO_SIDED|95.0|0.903|1.084|||Regression, Cox|||The Cox regression model effects consisted of six treatment effects, 15 two-way treatment interactions, and three covariates : gender and two items from the Fagerstrom Test of Nicotine Dependence (Item 1: time to first cigarette; Item 4: cigarettes per day).||1.084|.903|.814
72364047|NCT01116986|144239795|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.925||||0.093|TWO_SIDED|95.0|0.844|1.013|||Regression, Cox|||The Cox regression model effects consisted of six treatment effects, 15 two-way treatment interactions, and three covariates : gender and two items from the Fagerstrom Test of Nicotine Dependence (Item 1: time to first cigarette; Item 4: cigarettes per day).||1.013|.844|.093
72364048|NCT01116986|144239795|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.983||||0.716|TWO_SIDED|95.0|0.898|1.077|||Regression, Cox|||The Cox regression model effects consisted of six treatment effects, 15 two-way treatment interactions, and three covariates : gender and two items from the Fagerstrom Test of Nicotine Dependence (Item 1: time to first cigarette; Item 4: cigarettes per day).||1.077|.898|.716
72364049|NCT01116986|144239795|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.031||||0.511|TWO_SIDED|95.0|0.941|1.13|||Regression, Cox|||The Cox regression model effects consisted of six treatment effects, 15 two-way treatment interactions, and three covariates : gender and two items from the Fagerstrom Test of Nicotine Dependence (Item 1: time to first cigarette; Item 4: cigarettes per day).||1.130|.941|.511
72364050|NCT01116986|144239796|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.087||||0.341|TWO_SIDED|95.0|0.916|1.29|||Regression, Logistic|||The logistic regression model effects consisted of six treatment main effects and 15 two-way treatment interactions. The main effects provide direct tests of the primary aim of the study, i.e., determining whether or not more intensive treatments (compared to less intensive treatments; e.g., No Pre-Quit Nicotine Patch vs. Pre-Quit Nicotine Patch) would result in significantly higher abstinence at 16 weeks post-quit.||1.290|.916|.341
72364051|NCT01116986|144239796|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.117||||0.207|TWO_SIDED|95.0|0.941|1.325|||Regression, Logistic|||The logistic regression model effects consisted of six treatment main effects and 15 two-way treatment interactions. The main effects provide direct tests of the primary aim of the study, i.e., determining whether or not more intensive treatments (compared to less intensive treatments; e.g., No Pre-Quit Nicotine Gum vs. Pre-Quit Nicotine Gum) would result in significantly higher abstinence at 16 weeks post-quit.||1.325|.941|.207
72364052|NCT01116986|144239796|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.196||||0.041|TWO_SIDED|95.0|1.008|1.42|||Regression, Logistic|||The logistic regression model effects consisted of six treatment main effects and 15 two-way treatment interactions. The main effects provide direct tests of the primary aim of the study, i.e., determining whether or not more intensive treatments (compared to less intensive treatments; e.g., No Counseling Before the Quit Attempt vs. Counseling Before the Quit Attempt) would result in significantly higher abstinence at 16 weeks post-quit.||1.420|1.008|.041
72364053|NCT01116986|144239796|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.056||||0.536|TWO_SIDED|95.0|0.889|1.254|||Regression, Logistic|||The logistic regression model effects consisted of six treatment main effects and 15 two-way treatment interactions. The main effects provide direct tests of the primary aim of the study, i.e., determining whether or not more intensive treatments (compared to less intensive treatments; e.g., Minimal In-person Counseling During the Quit Attempt vs. Intensive In-person Counseling During the Quit Attempt) would result in significantly higher abstinence at 16 weeks post-quit.||1.254|.889|.536
72364054|NCT01116986|144239796|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.049||||0.587|TWO_SIDED|95.0|0.883|1.246|||Regression, Logistic|||The logistic regression model effects consisted of six treatment main effects and 15 two-way treatment interactions. The main effects provide direct tests of the primary aim of the study, i.e., determining whether or not more intensive treatments (compared to less intensive treatments; e.g., Minimal Phone Counseling During the Quit Attempt vs. Intensive Phone Counseling During the Quit Attempt) would result in significantly higher abstinence at 16 weeks post-quit.||1.246|.883|.587
72364055|NCT01116986|144239796|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.078||||0.389|TWO_SIDED|95.0|0.909|1.278|||Regression, Logistic|||The logistic regression model effects consisted of six treatment main effects and 15 two-way treatment interactions. The main effects provide direct tests of the primary aim of the study, i.e., determining whether or not more intensive treatments (compared to less intensive treatments; e.g., Short Term (8 Weeks) Postquit Nicotine Patch + Nicotine Gum vs. Long Term (26 Weeks) Postquit Nicotine Patch + Nicotine Gum) would result in significantly higher abstinence at 16 weeks post-quit.||1.278|.909|.389
72364056|NCT03819114|144239797|EQUIVALENCE|Confidence Interval (CI) on Geometric Mean Ratio compared to reference interval (0.7, 1.43).|Geometric Mean Ratio|0.99|||||TWO_SIDED|90.0|0.81|1.2|||||The ratios of the geometric means (group B / group C) and its 90% CI were obtained by exponentiating the least squares mean difference and its 90% CI of the natural log-transformed data.|||1.20|0.81|
72431517|NCT04736056|144374974|OTHER||Cohen's d effect size|0.89|||||TWO_SIDED|95.0|0.47|1.3||||||0 to 12 weeks||1.30|0.47|
72431518|NCT04736056|144374974|OTHER||Cohen's d effect size|0.66|||||TWO_SIDED|95.0|0.26|1.05||||||0 to 16 weeks||1.05|0.26|
72431519|NCT04736056|144374975|OTHER||Cohen's d effect size|-0.4|||||TWO_SIDED|95.0|-0.76|-0.03||||||0 to 12 weeks||-0.03|-0.76|
72364057|NCT03819114|144239797|EQUIVALENCE|Confidence Interval on Geometric Mean Ratio compared to reference interval (0.7, 1.43).|Geometric Mean Ratio|1.34|||||TWO_SIDED|90.0|1.12|1.6|||||The ratios of the geometric means (group D / group C) and its 90% CI were obtained by exponentiating the least squares mean difference and its 90% CI of the natural log-transformed data.|||1.60|1.12|
72364058|NCT03819114|144239797|SUPERIORITY|Confidence Interval on Geometric Mean Ratio excluding 1.|Geometric Mean Ratio|1.66|||||TWO_SIDED|90.0|1.27|2.18|||||The ratios of the geometric means (group B / group A) and its 90% CI were obtained by exponentiating the least squares mean difference and its 90% CI of the natural log-transformed data.|||2.18|1.27|
72364059|NCT03819114|144239797|SUPERIORITY|Confidence Interval on Geometric Mean Ratio excluding 1.|Geometric Mean Ratio|0.59|||||TWO_SIDED|90.0|0.45|0.78|||||The ratios of the geometric means (group A / group C) and its 90% CI were obtained by exponentiating the least squares mean difference and its 90% CI of the natural log-transformed data.|||0.78|0.45|
72364060|NCT03819114|144239798|SUPERIORITY|||||||1||||||No adjustments for multiple comparisons were made. Statistical significance was declared if p\<0.05.|Fisher Exact|||||||1.00
72364061|NCT03819114|144239799|OTHER|No hypothesis testing was performed.|Geometric Mean Ratio|1.17|||||TWO_SIDED|90.0|0.96|1.41|||||The ratios of the geometric means (group B / group C) and its 90% CI were obtained by exponentiating the least squares mean difference and its 90% CI of the natural log-transformed data.|||1.41|0.96|
72364062|NCT03819114|144239799|OTHER|No hypothesis testing was performed.|Geometric Mean Ratio|1.43|||||TWO_SIDED|90.0|1.21|1.69|||||The ratios of the geometric means (group D / group C) and its 90% CI were obtained by exponentiating the least squares mean difference and its 90% CI of the natural log-transformed data.|||1.69|1.21|
72364063|NCT03819114|144239799|OTHER|No hypothesis testing was performed.|Geometric Mean Ratio|1.51|||||TWO_SIDED|90.0|1.17|1.96|||||The ratios of the geometric means (group B / group A) and its 90% CI were obtained by exponentiating the least squares mean difference and its 90% CI of the natural log-transformed data.|||1.96|1.17|
72364064|NCT03819114|144239799|OTHER|No hypothesis testing was performed.|Geometric Mean Ratio|0.77|||||TWO_SIDED|90.0|0.6|1.0|||||The ratios of the geometric means (group A / group C) and its 90% CI were obtained by exponentiating the least squares mean difference and its 90% CI of the natural log-transformed data.|||1.00|0.60|
72364065|NCT03819114|144239800|OTHER|No hypothesis testing was performed.|Geometric Mean Ratio|0.37|||||TWO_SIDED|90.0|0.22|0.61|||||The ratios of the geometric means (group B / group C) and its 90% CI were obtained by exponentiating the least squares mean difference and its 90% CI of the natural log-transformed data.|||0.61|0.22|
72364066|NCT03819114|144239800|OTHER|No hypothesis testing was performed.|Geometric Mean Ratio|0.25|||||TWO_SIDED|90.0|0.15|0.44|||||The ratios of the geometric means (group D / group C) and its 90% CI were obtained by exponentiating the least squares mean difference and its 90% CI of the natural log-transformed data.|||0.44|0.15|
72364067|NCT03819114|144239800|OTHER|No hypothesis testing was performed.|Geometric Mean Ratio|2.11|||||TWO_SIDED|90.0|1.2|3.7|||||The ratios of the geometric means (group B / group A) and its 90% CI were obtained by exponentiating the least squares mean difference and its 90% CI of the natural log-transformed data.|||3.70|1.20|
72364068|NCT03819114|144239800|OTHER|No hypothesis testing was performed.|Geometric Mean Ratio|0.17|||||TWO_SIDED|90.0|0.09|0.32|||||The ratios of the geometric means (group A / group C) and its 90% CI were obtained by exponentiating the least squares mean difference and its 90% CI of the natural log-transformed data.|||0.32|0.09|
72364069|NCT03819114|144239801|OTHER|No hypothesis testing was performed.|Geometric Mean Ratio|4.03|||||TWO_SIDED|90.0|3.17|5.12|||||The ratios of the geometric means (group B / group C) and its 90% CI were obtained by exponentiating the least squares mean difference and its 90% CI of the natural log-transformed data.|||5.12|3.17|
72364070|NCT03819114|144239801|OTHER|No hypothesis testing was performed.|Geometric Mean Ratio|2.92|||||TWO_SIDED|90.0|2.33|3.65|||||The ratios of the geometric means (group D / group C) and its 90% CI were obtained by exponentiating the least squares mean difference and its 90% CI of the natural log-transformed data.|||3.65|2.33|
72364071|NCT03819114|144239801|OTHER|No hypothesis testing was performed.|Geometric Mean Ratio|1.11|||||TWO_SIDED|90.0|0.82|1.52|||||The ratios of the geometric means (group B / group A) and its 90% CI were obtained by exponentiating the least squares mean difference and its 90% CI of the natural log-transformed data.|||1.52|0.82|
72364072|NCT03819114|144239801|OTHER|No hypothesis testing was performed.|Geometric Mean Ratio|3.62|||||TWO_SIDED|90.0|2.65|4.93|||||The ratios of the geometric means (group A / group C) and its 90% CI were obtained by exponentiating the least squares mean difference and its 90% CI of the natural log-transformed data.|||4.93|2.65|
72364073|NCT03819114|144239802|OTHER|No hypothesis testing was performed.|Geometric Mean Ratio|2.1|||||TWO_SIDED|90.0|1.66|2.65|||||The ratios of the geometric means (group B / group C) and its 90% CI were obtained by exponentiating the least squares mean difference and its 90% CI of the natural log-transformed data.|||2.65|1.66|
72364074|NCT03819114|144239802|OTHER|No hypothesis testing was performed.|Geometric Mean Ratio|1.11|||||TWO_SIDED|90.0|0.89|1.39|||||The ratios of the geometric means (group D / group C) and its 90% CI were obtained by exponentiating the least squares mean difference and its 90% CI of the natural log-transformed data.|||1.39|0.89|
72364075|NCT03819114|144239802|OTHER|No hypothesis testing was performed.|Geometric Mean Ratio|1.2|||||TWO_SIDED|90.0|0.87|1.66|||||The ratios of the geometric means (group B / group A) and its 90% CI were obtained by exponentiating the least squares mean difference and its 90% CI of the natural log-transformed data.|||1.66|0.87|
72364076|NCT03819114|144239802|OTHER|No hypothesis testing was performed.|Geometric Mean Ratio|1.75|||||TWO_SIDED|90.0|1.24|2.45|||||The ratios of the geometric means (group A / group C) and its 90% CI were obtained by exponentiating the least squares mean difference and its 90% CI of the natural log-transformed data.|||2.45|1.24|
72364077|NCT03819114|144239803|OTHER|No hypothesis testing was performed.|Geometric Mean Ratio|0.52|||||TWO_SIDED|90.0|0.46|0.59|||||The ratios of the geometric means (group B / group C) and its 90% CI were obtained by exponentiating the least squares mean difference and its 90% CI of the natural log-transformed data.|||0.59|0.46|
72364078|NCT03819114|144239803|OTHER|No hypothesis testing was performed.|Geometric Mean Ratio|0.38|||||TWO_SIDED|90.0|0.34|0.43|||||The ratios of the geometric means (group D / group C) and its 90% CI were obtained by exponentiating the least squares mean difference and its 90% CI of the natural log-transformed data.|||0.43|0.34|
72364079|NCT03819114|144239803|OTHER|No hypothesis testing was performed.|Geometric Mean Ratio|1.08|||||TWO_SIDED|90.0|0.93|1.25|||||The ratios of the geometric means (group B / group A) and its 90% CI were obtained by exponentiating the least squares mean difference and its 90% CI of the natural log-transformed data.|||1.25|0.93|
72364080|NCT03819114|144239803|OTHER|No hypothesis testing was performed.|Geometric Mean Ratio|0.48|||||TWO_SIDED|90.0|0.41|0.56|||||The ratios of the geometric means (group A / group C) and its 90% CI were obtained by exponentiating the least squares mean difference and its 90% CI of the natural log-transformed data.|||0.56|0.41|
72364081|NCT03819114|144239805|OTHER|No hypothesis testing was performed.|Geometric Mean Ratio|0.75|||||TWO_SIDED|90.0|0.6|0.93|||||The ratios of the geometric means (group B / group C) and its 90% CI were obtained by exponentiating the least squares mean difference and its 90% CI of the natural log-transformed data.|||0.93|0.60|
72364082|NCT03819114|144239805|OTHER|No hypothesis testing was performed.|Geometric Mean Ratio|1.1|||||TWO_SIDED|90.0|0.9|1.36|||||The ratios of the geometric means (group D / group C) and its 90% CI were obtained by exponentiating the least squares mean difference and its 90% CI of the natural log-transformed data.|||1.36|0.90|
72431520|NCT04736056|144374975|OTHER||Cohen's d effect size|-0.34|||||TWO_SIDED|95.0|-0.71|0.03||||||0 to 16 weeks||0.03|-0.71|
72431521|NCT04736056|144374976|OTHER||Cohen's d effect size|0.0|||||TWO_SIDED|95.0|-0.35|0.35||||||0 to 12 weeks||0.35|-0.35|
72431522|NCT04736056|144374976|OTHER||Cohen's d effect size|-0.28|||||TWO_SIDED|95.0|-0.64|0.09||||||0 to 16 weeks||0.09|-0.64|
72431523|NCT04736056|144374977|OTHER||Cohen's d effect size|0.1|||||TWO_SIDED|95.0|-0.45|0.26||||||||0.26|-0.45|
72431524|NCT04736056|144374977|OTHER||Cohen's d effect size|0.09|||||TWO_SIDED|95.0|-0.27|0.45||||||0 to 16 weeks||0.45|-0.27|
72431525|NCT04736056|144374978|OTHER||Cohen's d effect size|-0.035|||||TWO_SIDED|95.0|-0.71|0.01||||||0 to 12 weeks||0.01|-0.71|
72431526|NCT04736056|144374978|OTHER||Cohen's d effect size|-0.29|||||TWO_SIDED|95.0|-0.65|0.08||||||0 to 16 weeks||0.08|-0.65|
72431527|NCT04736056|144374979|OTHER||Cohen's d effect size|-0.34|||||TWO_SIDED|95.0|-0.7|0.03||||||0 to 12 weeks||0.03|-0.70|
72431528|NCT04736056|144374979|OTHER||Cohen's d effect size|-0.47|||||TWO_SIDED|95.0|-0.85|-0.09||||||0 to 16 weeks||-0.09|-0.85|
72431529|NCT03437668|144374984|SUPERIORITY|To test for a differential treatment effect, we fit a linear mixed with group, time, and a group by time interaction as the predictors and random intercepts to account for the correlations induced by the repeated measurements within subjects. Given the form of the trajectories and the small sample size, we chose to treat time as continuous to minimize the number of degrees of freedom and the risk of overfitting.|Slope|-0.22||||0.31|TWO_SIDED|||||p-value is for the interaction of time and treatment group in the mixed model|Mixed Models Analysis|||||||.31
72431530|NCT00819234|144375006|SUPERIORITY_OR_OTHER||LS Mean Difference|-7.23|STANDARD_ERROR_OF_MEAN|2.863||0.0135|TWO_SIDED|95.0|-12.93|-1.54|||t-test, 2 sided|||Treatment comparisons between each active treatment and placebo. Statistical tests performed two-sided at a significance level of α = 0.05. The null hypothesis tested was that there is no difference between each active treatment and the placebo treatment. The primary analysis did not incorporate any adjustment for multiple comparisons.||-1.54|-12.93|0.0135
72431531|NCT00819234|144375006|SUPERIORITY_OR_OTHER||LS Mean|-6.55|STANDARD_ERROR_OF_MEAN|2.681||0.0168|TWO_SIDED|95.0|-11.89|-1.21|||t-test, 2 sided|||Treatment comparisons between each active treatment and placebo. Statistical tests performed two-sided at a significance level of α = 0.05. The null hypothesis tested was that there is no difference between each active treatment and the placebo treatment. The primary analysis did not incorporate any adjustment for multiple comparisons||-1.21|-11.89|0.0168
72431532|NCT00819234|144375006|SUPERIORITY_OR_OTHER||LS Mean|-5.52|STANDARD_ERROR_OF_MEAN|2.887||0.0595|TWO_SIDED|95.0|-11.27|0.23|||t-test, 2 sided|||Treatment comparisons between each active treatment and placebo. Statistical tests performed two-sided at a significance level of α = 0.05. The null hypothesis tested was that there is no difference between each active treatment and the placebo treatment. The primary analysis did not incorporate any adjustment for multiple comparisons||0.23|-11.27|0.0595
72431533|NCT01823341|144375026|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||t-test, 2 sided|||||||<0.001
72431534|NCT01823341|144375027|SUPERIORITY_OR_OTHER|||||||0.01|TWO_SIDED||||||t-test, 2 sided|||||||0.01
72431535|NCT01823341|144375027|SUPERIORITY_OR_OTHER|||||||0.04|TWO_SIDED||||||t-test, 2 sided|||||||0.04
72431536|NCT01823341|144375028|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||t-test, 2 sided|||||||<0.001
72431537|NCT01823341|144375028|SUPERIORITY_OR_OTHER|||||||0.005|TWO_SIDED||||||t-test, 2 sided|||||||0.005
72431538|NCT01823341|144375029|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||t-test, 2 sided|||||||<0.001
72431539|NCT01823341|144375029|SUPERIORITY_OR_OTHER|||||||0.004|TWO_SIDED||||||t-test, 2 sided|||||||0.004
72431540|NCT01823341|144375030|SUPERIORITY_OR_OTHER|||||||0.1|TWO_SIDED||||||t-test, 2 sided|||||||0.10
72431541|NCT01823341|144375030|SUPERIORITY_OR_OTHER|||||||0.5|TWO_SIDED||||||t-test, 2 sided|||||||0.50
72431542|NCT01823341|144375031|SUPERIORITY_OR_OTHER|||||||0.18|TWO_SIDED||||||t-test, 2 sided|||||||0.18
72431543|NCT01823341|144375031|SUPERIORITY_OR_OTHER|||||||0.77|TWO_SIDED||||||t-test, 2 sided|||||||0.77
72431544|NCT01823341|144375032|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||t-test, 2 sided|||||||<0.001
72431545|NCT01823341|144375032|SUPERIORITY_OR_OTHER|||||||0.11|TWO_SIDED||||||t-test, 2 sided|||||||0.11
72431546|NCT01823341|144375033|SUPERIORITY_OR_OTHER|||||||0.57|TWO_SIDED||||||t-test, 2 sided|||||||0.57
72431547|NCT01823341|144375033|SUPERIORITY_OR_OTHER|||||||0.18|TWO_SIDED||||||t-test, 2 sided|||||||0.18
72431548|NCT01823341|144375034|SUPERIORITY_OR_OTHER|||||||0.16|TWO_SIDED||||||t-test, 2 sided|||||||0.16
72431549|NCT01823341|144375034|SUPERIORITY_OR_OTHER|||||||0.39|TWO_SIDED||||||t-test, 2 sided|||||||0.39
72431550|NCT01823341|144375035|SUPERIORITY_OR_OTHER|||||||0.53|TWO_SIDED||||||t-test, 2 sided|||||||0.53
72431551|NCT01823341|144375035|SUPERIORITY_OR_OTHER|||||||0.28|TWO_SIDED||||||t-test, 2 sided|||||||0.28
72431552|NCT00924560|144375036|NON_INFERIORITY_OR_EQUIVALENCE|91-day levonorgestrel OC was declared to be non-inferior to the untreated control group if the lower bound of the 2-sided 95% confidence interval (CI) was greater than -3%.|LS Mean Difference|-0.23|||||TWO_SIDED|95.0|-0.67|0.2|||||Difference = OC group minus the untreated control|The primary efficacy endpoint (percent change from baseline to 12 months in lumbar spine BMD) was analyzed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and chronological age, body weight, and Baseline value as covariates.||0.20|-0.67|
72431553|NCT00924560|144375036|NON_INFERIORITY_OR_EQUIVALENCE|28-day levonorgestrel OC was declared to be non-inferior to the untreated control group if the lower bound of the 2-sided 95% confidence interval (CI) was greater than -3%.|LS Mean Difference|-1.05|||||TWO_SIDED|95.0|-1.49|-0.61|||||Difference = OC group minus the untreated control|The primary efficacy endpoint (percent change from baseline to 12 months in lumbar spine BMD) was analyzed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and chronological age, body weight, and Baseline value as covariates.||-0.61|-1.49|
72431554|NCT00924560|144375037|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0|||||TWO_SIDED|95.0|0.0|0.01||||||Comparison of Change from Baseline to Month 6. ANCOVA model with treatment as a fixed effect and chronological age, body weight, and Baseline value as covariates.||0.01|-0.00|
72364083|NCT03819114|144239805|OTHER|No hypothesis testing was performed.|Geometric Mean Ratio|1.74|||||TWO_SIDED|90.0|1.29|2.33|||||The ratios of the geometric means (group B / group A) and its 90% CI were obtained by exponentiating the least squares mean difference and its 90% CI of the natural log-transformed data.|||2.33|1.29|
72364084|NCT03819114|144239805|OTHER|No hypothesis testing was performed.|Geometric Mean Ratio|0.43|||||TWO_SIDED|90.0|0.32|0.58|||||The ratios of the geometric means (group A / group C) and its 90% CI were obtained by exponentiating the least squares mean difference and its 90% CI of the natural log-transformed data.|||0.58|0.32|
72364085|NCT03819114|144239806|OTHER|No hypothesis testing was performed.|Geometric Mean Ratio|0.62|||||TWO_SIDED|90.0|0.49|0.78|||||The ratios of the geometric means (group B / group C) and its 90% CI were obtained by exponentiating the least squares mean difference and its 90% CI of the natural log-transformed data.|||0.78|0.49|
72364086|NCT03819114|144239806|OTHER|No hypothesis testing was performed.|Geometric Mean Ratio|0.89|||||TWO_SIDED|90.0|0.71|1.1|||||The ratios of the geometric means (group D / group C) and its 90% CI were obtained by exponentiating the least squares mean difference and its 90% CI of the natural log-transformed data.|||1.10|0.71|
72364087|NCT03819114|144239806|OTHER|No hypothesis testing was performed.|Geometric Mean Ratio|1.77|||||TWO_SIDED|90.0|1.31|2.4|||||The ratios of the geometric means (group B / group A) and its 90% CI were obtained by exponentiating the least squares mean difference and its 90% CI of the natural log-transformed data.|||2.40|1.31|
72364088|NCT03819114|144239806|OTHER|No hypothesis testing was performed.|Geometric Mean Ratio|0.35|||||TWO_SIDED|90.0|0.26|0.47|||||The ratios of the geometric means (group A / group C) and its 90% CI were obtained by exponentiating the least squares mean difference and its 90% CI of the natural log-transformed data.|||0.47|0.26|
72364089|NCT03819114|144239807|OTHER|No hypothesis testing was performed.|Geometric Mean Ratio|0.5|||||TWO_SIDED|90.0|0.39|0.63|||||The ratios of the geometric means (group B / group C) and its 90% CI were obtained by exponentiating the least squares mean difference and its 90% CI of the natural log-transformed data.|||0.63|0.39|
72364090|NCT03819114|144239807|OTHER|No hypothesis testing was performed.|Geometric Mean Ratio|0.69|||||TWO_SIDED|90.0|0.55|0.86|||||The ratios of the geometric means (group D / group C) and its 90% CI were obtained by exponentiating the least squares mean difference and its 90% CI of the natural log-transformed data.|||0.86|0.55|
72364091|NCT03819114|144239807|OTHER|No hypothesis testing was performed.|Geometric Mean Ratio|1.8|||||TWO_SIDED|90.0|1.32|2.45|||||The ratios of the geometric means (group B / group A) and its 90% CI were obtained by exponentiating the least squares mean difference and its 90% CI of the natural log-transformed data.|||2.45|1.32|
72364092|NCT03819114|144239807|OTHER|No hypothesis testing was performed.|Geometric Mean Ratio|0.28|||||TWO_SIDED|90.0|0.2|0.38|||||The ratios of the geometric means (group A / group C) and its 90% CI were obtained by exponentiating the least squares mean difference and its 90% CI of the natural log-transformed data.|||0.38|0.20|
72431555|NCT00924560|144375037|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.01|||||TWO_SIDED|95.0|-0.01|0.0||||||Comparison of Change from Baseline to Month 6. ANCOVA model with treatment as a fixed effect and chronological age, body weight, and Baseline value as covariates.||-0.00|-0.01|
72431556|NCT00924560|144375037|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0|||||TWO_SIDED|95.0|-0.01|0.0||||||Comparison of Change from Baseline to Month 12. ANCOVA model with treatment as a fixed effect and chronological age, body weight, and Baseline value as covariates.||0.00|-0.01|
72431557|NCT00924560|144375037|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.01|||||TWO_SIDED|95.0|-0.02|-0.01||||||Comparison of Change from Baseline to Month 12. ANCOVA model with treatment as a fixed effect and chronological age, body weight, and Baseline value as covariates.||-0.01|-0.02|
72431558|NCT00924560|144375038|SUPERIORITY_OR_OTHER||LS Mean Difference|0.17|||||TWO_SIDED|95.0|-0.08|0.42||||||Comparison of Change from Baseline to Month 6. ANCOVA model with treatment as a fixed effect and chronological age, body weight, and Baseline value as covariates.||0.42|-0.08|
72431559|NCT00924560|144375038|SUPERIORITY_OR_OTHER||LS mean Difference|-0.43|||||TWO_SIDED|95.0|-0.68|-0.18||||||Comparison of Change from Baseline to Month 6. ANCOVA model with treatment as a fixed effect and chronological age, body weight, and Baseline value as covariates.||-0.18|-0.68|
72431560|NCT00924560|144375038|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.07|||||TWO_SIDED|95.0|-0.39|0.24||||||Comparison of Change from Baseline to Month 12. ANCOVA model with treatment as a fixed effect and chronological age, body weight, and Baseline value as covariates.||0.24|-0.39|
72431561|NCT00924560|144375038|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.74|||||TWO_SIDED|95.0|-1.05|-0.42||||||Comparison of Change from Baseline to Month 12. ANCOVA model with treatment as a fixed effect and chronological age, body weight, and Baseline value as covariates.||-0.42|-1.05|
72431562|NCT00924560|144375039|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0|||||TWO_SIDED|95.0|0.0|0.01||||||Comparison of Change from Baseline to Month 6. ANCOVA model with treatment as a fixed effect and chronological age, body weight, and Baseline value as covariates.||0.01|0.00|
72431563|NCT00924560|144375039|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0|||||TWO_SIDED|95.0|-0.01|0.0||||||Comparison of Change from Baseline to Month 6. ANCOVA model with treatment as a fixed effect and chronological age, body weight, and Baseline value as covariates.||0.00|-0.01|
72431564|NCT00924560|144375039|SUPERIORITY_OR_OTHER||LS Mean Difference|0.01|||||TWO_SIDED|95.0|0.0|0.01||||||Comparison of Change from Baseline to Month 12. ANCOVA model with treatment as a fixed effect and chronological age, body weight, and Baseline value as covariates.||0.01|0.00|
72431565|NCT00924560|144375039|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0|||||TWO_SIDED|0.95|-0.01|0.0||||||Comparison of Change from Baseline to Month 12. ANCOVA model with treatment as a fixed effect and chronological age, body weight, and Baseline value as covariates.||0.00|-0.01|
72431566|NCT00924560|144375040|SUPERIORITY_OR_OTHER||LS mean Difference|0.13|||||TWO_SIDED|95.0|-0.03|0.28||||||Comparison of Change from Baseline to Month 6. ANCOVA model with treatment as a fixed effect and chronological age, body weight, and Baseline value as covariates.||0.28|-0.03|
72431567|NCT00924560|144375040|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.04|||||TWO_SIDED|95.0|-0.2|0.11||||||Comparison of Change from Baseline to Month 6. ANCOVA model with treatment as a fixed effect and chronological age, body weight, and Baseline value as covariates.||0.11|-0.20|
72431568|NCT00924560|144375040|SUPERIORITY_OR_OTHER||LS Mean Difference|0.16|||||TWO_SIDED|95.0|-0.01|0.34||||||Comparison of Change from Baseline to Month 12. ANCOVA model with treatment as a fixed effect and chronological age, body weight, and Baseline value as covariates.||0.34|-0.01|
72364093|NCT02492763|144239808|SUPERIORITY||Difference in Least Squares Means|-0.39||||0.126|TWO_SIDED|95.0|-0.88|0.11|||Longitudinal data analysis|Terms for treatment, time, A1C (\<8.5%, ≥8.5%), BMI (\<30 kg/m\^2, ≥30 kg/m\^2) and AHA washout status (Yes, No), and the interaction of time by treatment||||0.11|-0.88|0.126
72364094|NCT02492763|144239808|SUPERIORITY||Difference in Least Squares Means|0.6||||0.017|TWO_SIDED|95.0|0.11|1.08|||Longitudinal data analysis|Terms for treatment, time, A1C (\<8.5%, ≥8.5%), BMI (\<30 kg/m\^2, ≥30 kg/m\^2) and AHA washout status (Yes, No), and the interaction of time by treatment||||1.08|0.11|0.017
72364095|NCT02492763|144239808|SUPERIORITY||Difference in Least Squares Means|-0.61||||0.018|TWO_SIDED|95.0|-1.12|-0.1|||Longitudinal data analysis|Terms for treatment, time, A1C (\<8.5%, ≥8.5%), BMI (\<30 kg/m\^2, ≥30 kg/m\^2) and AHA washout status (Yes, No), and the interaction of time by treatment||||-0.10|-1.12|0.018
72364096|NCT02492763|144239808|SUPERIORITY||Difference in Least Squares Means|0.37||||0.146|TWO_SIDED|95.0|-0.13|0.87|||Longitudinal data analysis|Terms for treatment, time, A1C (\<8.5%, ≥8.5%), BMI (\<30 kg/m\^2, ≥30 kg/m\^2) and AHA washout status (Yes, No), and the interaction of time by treatment||||0.87|-0.13|0.146
72364097|NCT02492763|144239808|SUPERIORITY||Difference in the Least Squares Means|-0.98|||<|0.001|TWO_SIDED|95.0|-1.49|-0.48||Terms for treatment, time, A1C (\<8.5%, ≥8.5%), BMI (\<30 kg/m\^2, ≥30 kg/m\^2) and AHA washout status (Yes, No), and the interaction of time by treatment|Longitudinal data analysis|||||-0.48|-1.49|<0.001
72364098|NCT02492763|144239811|SUPERIORITY||Difference in % vs Placebo|-2.3||||0.301|TWO_SIDED|95.0|-12.1|5.6|||Miettinen & Nurminen method|||||5.6|-12.1|0.301
72364099|NCT02492763|144239811|SUPERIORITY||Difference in % vs Placebo|2.2||||0.573|TWO_SIDED|95.0|-8.1|13.2|||Miettinen & Nurminen method|||||13.2|-8.1|0.573
72364100|NCT02492763|144239811|SUPERIORITY||Difference in % vs Liraglutide|-2.4||||0.295|TWO_SIDED|95.0|-12.4|5.5|||Miettinen & Nurminen method|||||5.5|-12.4|0.295
72364101|NCT02492763|144239811|SUPERIORITY||Difference in % vs Liraglutide|2.2||||0.587|TWO_SIDED|95.0|-8.4|13.2|||Miettinen & Nurminen method|||||13.2|-8.4|0.587
72364102|NCT02492763|144239812|SUPERIORITY||Difference in the LS Means vs. Placebo|6.9|||||TWO_SIDED|95.0|3.42|10.37|||||Terms for treatment, time, A1C (\<8.5%, ≥8.5%), BMI (\<30 kg/m\^2, ≥30 kg/m\^2) and AHA washout status (Yes, No), and the interaction of time by treatment||Longitudinal data analysis|10.37|3.42|
72364103|NCT02492763|144239812|SUPERIORITY||Difference in LS Means vs. Liraglutide|3.84|||||TWO_SIDED|95.0|0.35|7.33|||||Terms for treatment, time, A1C (\<8.5%, ≥8.5%), BMI (\<30 kg/m\^2, ≥30 kg/m\^2) and AHA washout status (Yes, No), and the interaction of time by treatment||Longitudinal data analysis|7.33|0.35|
72364104|NCT02492763|144239812|SUPERIORITY||Difference in LS Means vs. Placebo|7.7|||||TWO_SIDED|95.0|4.17|11.23|||||Terms for treatment, time, A1C (\<8.5%, ≥8.5%), BMI (\<30 kg/m\^2, ≥30 kg/m\^2) and AHA washout status (Yes, No), and the interaction of time by treatment||Longitudinal data analysis|11.23|4.17|
72364105|NCT02492763|144239812|SUPERIORITY||Difference in LS Means vs. Liraglutide|4.65|||||TWO_SIDED|95.0|1.11|8.19|||||Terms for treatment, time, A1C (\<8.5%, ≥8.5%), BMI (\<30 kg/m\^2, ≥30 kg/m\^2) and AHA washout status (Yes, No), and the interaction of time by treatment||Longitudinal data analysis|8.19|1.11|
72364106|NCT02492763|144239813|SUPERIORITY||Difference in Least Squares Means|-0.7||||0.285|TWO_SIDED|95.0|-2.0|0.6|||Longitudinal data analysis|Terms for treatment, time, A1C (\<8.5%, ≥8.5%), BMI (\<30 kg/m\^2, ≥30 kg/m\^2) and AHA washout status (Yes, No), and the interaction of time by treatment||||0.6|-2.0|0.285
72364107|NCT02492763|144239813|SUPERIORITY||Difference in Least Squares Means|0.9||||0.183|TWO_SIDED|95.0|-0.4|2.2|||Longitudinal data analysis|Terms for treatment, time, A1C (\<8.5%, ≥8.5%), BMI (\<30 kg/m\^2, ≥30 kg/m\^2) and AHA washout status (Yes, No), and the interaction of time by treatment||||2.2|-0.4|0.183
72364108|NCT02492763|144239813|SUPERIORITY||Difference in Least Squares Means|-1.8||||0.01|TWO_SIDED|95.0|-3.1|-0.4|||Longitudinal data analysis|Terms for treatment, time, A1C (\<8.5%, ≥8.5%), BMI (\<30 kg/m\^2, ≥30 kg/m\^2) and AHA washout status (Yes, No), and the interaction of time by treatment||||-0.4|-3.1|0.010
72364109|NCT02492763|144239813|SUPERIORITY||Difference in Least Squares Means|-0.2||||0.811|TWO_SIDED|95.0|-1.5|1.2|||Longitudinal data analysis|Terms for treatment, time, A1C (\<8.5%, ≥8.5%), BMI (\<30 kg/m\^2, ≥30 kg/m\^2) and AHA washout status (Yes, No), and the interaction of time by treatment||||1.2|-1.5|0.811
72364110|NCT02492763|144239813|SUPERIORITY||Difference in the Least Squares Means|-1.6||||0.018|TWO_SIDED|95.0|-2.9|-0.3||Terms for treatment, time, A1C (\<8.5%, ≥8.5%), BMI (\<30 kg/m\^2, ≥30 kg/m\^2) and AHA washout status (Yes, No), and the interaction of time by treatment|Longitudinal data analysis|||||-0.3|-2.9|0.018
72364111|NCT02492763|144239814|SUPERIORITY||Difference in Least Squares Means|-8.6||||0.385|TWO_SIDED|95.0|-28.2|10.9|||Longitudinal data analysis|Terms for treatment, time, A1C (\<8.5%, ≥8.5%), BMI (\<30 kg/m\^2, ≥30 kg/m\^2) and AHA washout status (Yes, No), and the interaction of time by treatment||||10.9|-28.2|0.385
72364112|NCT02492763|144239814|SUPERIORITY||Difference in Least Squares Means|29.1||||0.004|TWO_SIDED|95.0|9.7|48.6|||Longitudinal data analysis|Terms for treatment, time, A1C (\<8.5%, ≥8.5%), BMI (\<30 kg/m\^2, ≥30 kg/m\^2) and AHA washout status (Yes, No), and the interaction of time by treatment||||48.6|9.7|0.004
72364113|NCT02492763|144239814|SUPERIORITY||Difference in Least Squares Means|-29.5||||0.004|TWO_SIDED|95.0|-49.6|-9.4|||Longitudinal data analysis|Terms for treatment, time, A1C (\<8.5%, ≥8.5%), BMI (\<30 kg/m\^2, ≥30 kg/m\^2) and AHA washout status (Yes, No), and the interaction of time by treatment||||-9.4|-49.6|0.004
72364114|NCT02492763|144239814|SUPERIORITY||Difference in Least Squares Means|8.3||||0.416|TWO_SIDED|95.0|-11.7|28.2|||Longitudinal data analysis|Terms for treatment, time, A1C (\<8.5%, ≥8.5%), BMI (\<30 kg/m\^2, ≥30 kg/m\^2) and AHA washout status (Yes, No), and the interaction of time by treatment||||28.2|-11.7|0.416
72364115|NCT02492763|144239814|SUPERIORITY||Difference in the Least Squares Means|-37.8|||<|0.001|TWO_SIDED|95.0|-57.5|-18.0||Terms for treatment, time, A1C (\<8.5%, ≥8.5%), BMI (\<30 kg/m\^2, ≥30 kg/m\^2) and AHA washout status (Yes, No), and the interaction of time by treatment|Longitudinal data analysis|||||-18.0|-57.5|<0.001
72364116|NCT02492763|144239818|SUPERIORITY||Difference in Least Squares Means|-3.7||||0.151|TWO_SIDED|95.0|-8.8|1.4|||Longitudinal data analysis|Terms for treatment, time, A1C (\<8.5%, ≥8.5%), BMI (\<30 kg/m\^2, ≥30 kg/m\^2) and AHA washout status (Yes, No), and the interaction of time by treatment||||1.4|-8.8|0.151
72364117|NCT02492763|144239818|SUPERIORITY||Difference in Least Squares Means|-1.1||||0.682|TWO_SIDED|95.0|-6.2|4.1|||Longitudinal data analysis|Terms for treatment, time, A1C (\<8.5%, ≥8.5%), BMI (\<30 kg/m\^2, ≥30 kg/m\^2) and AHA washout status (Yes, No), and the interaction of time by treatment||||4.1|-6.2|0.682
72364118|NCT02492763|144239818|SUPERIORITY||Difference in Least Squares Means|-2.5||||0.344|TWO_SIDED|95.0|-7.7|2.7|||Longitudinal data analysis|Terms for treatment, time, A1C (\<8.5%, ≥8.5%), BMI (\<30 kg/m\^2, ≥30 kg/m\^2) and AHA washout status (Yes, No), and the interaction of time by treatment||||2.7|-7.7|0.344
72364119|NCT02492763|144239818|SUPERIORITY||Difference in Least Squares Means|0.2||||0.948|TWO_SIDED|95.0|-5.0|5.4|||Longitudinal data analysis|Terms for treatment, time, A1C (\<8.5%, ≥8.5%), BMI (\<30 kg/m\^2, ≥30 kg/m\^2) and AHA washout status (Yes, No), and the interaction of time by treatment||||5.4|-5.0|0.948
72364120|NCT02492763|144239818|SUPERIORITY||Difference in the Least Squares Means|-2.7||||0.306|TWO_SIDED|95.0|-7.8|2.5||Terms for treatment, time, A1C (\<8.5%, ≥8.5%), BMI (\<30 kg/m\^2, ≥30 kg/m\^2) and AHA washout status (Yes, No), and the interaction of time by treatment|Longitudinal data analysis|||||2.5|-7.8|0.306
72364121|NCT02492763|144239819|SUPERIORITY||Difference in Least Squares Means|1.5||||0.347|TWO_SIDED|95.0|-1.7|4.8|||Longitudinal data analysis|Terms for treatment, time, A1C (\<8.5%, ≥8.5%), BMI (\<30 kg/m\^2, ≥30 kg/m\^2) and AHA washout status (Yes, No), and the interaction of time by treatment||||4.8|-1.7|0.347
72364122|NCT02492763|144239819|SUPERIORITY||Difference in Least Squares Means|-0.1||||0.963|TWO_SIDED|95.0|-3.3|3.2|||Longitudinal data analysis|Terms for treatment, time, A1C (\<8.5%, ≥8.5%), BMI (\<30 kg/m\^2, ≥30 kg/m\^2) and AHA washout status (Yes, No), and the interaction of time by treatment||||3.2|-3.3|0.963
72364123|NCT02492763|144239819|SUPERIORITY||Difference in Least Squares Means|1.4||||0.394|TWO_SIDED|95.0|-1.9|4.7|||Longitudinal data analysis|Terms for treatment, time, A1C (\<8.5%, ≥8.5%), BMI (\<30 kg/m\^2, ≥30 kg/m\^2) and AHA washout status (Yes, No), and the interaction of time by treatment||||4.7|-1.9|0.394
72364124|NCT02492763|144239819|SUPERIORITY||Difference in Least Squares Means|-0.2||||0.905|TWO_SIDED|95.0|-3.5|3.1|||Longitudinal data analysis|Terms for treatment, time, A1C (\<8.5%, ≥8.5%), BMI (\<30 kg/m\^2, ≥30 kg/m\^2) and AHA washout status (Yes, No), and the interaction of time by treatment||||3.1|-3.5|0.905
72364125|NCT02492763|144239819|SUPERIORITY||Difference in the Least Squares Means|1.6||||0.325|TWO_SIDED|95.0|-1.6|4.9|||Longitudinal data analysis|Terms for treatment, time, A1C (\<8.5%, ≥8.5%), BMI (\<30 kg/m\^2, ≥30 kg/m\^2) and AHA washout status (Yes, No), and the interaction of time by treatment||||4.9|-1.6|0.325
72364126|NCT01391546|144239903|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was achieved if the lower bound of the 2-sided 95% confidence interval (CI) for the GMT ratio was greater than 2/3|GMT Ratio|1.05|||<|0.001|TWO_SIDED|95.0|0.93|1.18|||longitudinal regression model|Model adjusted for pre-vaccination titres and age at vaccination in years|GMT ratio = GMT IM route divided by GMT SC route|||1.18|0.93|<0.001
72364127|NCT01391546|144239904|SUPERIORITY_OR_OTHER||GMFR|2.7|||||TWO_SIDED|95.0|2.4|3.0|||||GMFR = GMT Post-vaccination/GMT Pre-vaccination|Acceptability was demonstrated if the lower bound of the two-sided 95% CI was \>1.4||3.0|2.4|
72364128|NCT01744977|144239947|NON_INFERIORITY_OR_EQUIVALENCE|With an assumed adherence proportion in the Control arm of 0.50, there is 80% power to detect a difference between Control and the intervention arms of 17% or more with 125 patients in each arm.||||||0.3|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.300
72364129|NCT01744977|144239948|NON_INFERIORITY_OR_EQUIVALENCE|With an assumed adherence proportion in the Control arm of 0.50, there is 80% power to detect a difference between Control and the intervention arms of 17% or more with 125 patients in each arm.|Mean Difference (Final Values)|-0.7||||0.839|TWO_SIDED|95.0|-8.0|6.5||As measured at 12m|Mixed Models Analysis||This value summarizes the full 12 month period so Mean Difference (Final Values) is appropriate.|||6.5|-8.0|0.839
72364130|NCT02703597|144239968|SUPERIORITY||Odds Ratio (OR)|1.15||||0.8|TWO_SIDED|95.0|0.32|4.2|||Mixed Models Analysis|||"Hypothesis: Participants in the GSA-ASPIRE-Network Group will be more likely to decrease in susceptibility to vaping than participants in the ASPIRE group.~The statistical analysis was conducted for 10 out of the 15 participating sites, to avoid bias with respect to the sites that participated in different conditions (i.e., 1 site in a school classroom during class time and 4 sites in the summer camp during summer time)."||4.20|0.32|0.80
72364131|NCT02703597|144239968|SUPERIORITY||Odds Ratio (OR)|0.17|||<|0.01|TWO_SIDED|95.0|0.06|0.43|||Mixed Models Analysis|||"Hypothesis: Participants in both arms will decrease in susceptibility to vaping over time.~The statistical analysis was conducted for 10 out of the 15 participating sites, to avoid bias with respect to the sites that participated in different conditions (i.e., 1 site in a school classroom during class time and 4 sites in the summer camp during summer time)."||0.43|0.06|<0.01
72364132|NCT02703597|144239969|SUPERIORITY||Odds Ratio (OR)|0.76||||0.7|TWO_SIDED|95.0|0.16|3.49|||Mixed Models Analysis|||"Hypothesis: Adolescents who participated in the GSA-ASPIRE-Network group will be more likely to decrease in susceptibility to using conventional tobacco than adolescents who participated in the ASPIRE group.~The statistical analysis was conducted for 10 out of the 15 participating sites, to avoid bias with respect to the sites that participated in different conditions (i.e., 1 site in a school classroom during class time and 4 sites in the summer camp during summer time)."||3.49|0.16|0.70
72364133|NCT02703597|144239969|SUPERIORITY||Odds Ratio (OR)|0.13|||<|0.01|TWO_SIDED|95.0|0.04|0.4|||Mixed Models Analysis|||"Hypothesis: Participants in both arms will decrease in susceptibility of using conventional tobacco over time.~The statistical analysis was conducted for 10 out of the 15 participating sites, to avoid bias with respect to the sites that participated in different conditions (i.e., 1 site in a school classroom during class time and 4 sites in the summer camp during summer time)."||0.40|0.04|<0.01
72364134|NCT00089752|144239990|NON_INFERIORITY_OR_EQUIVALENCE|Sample size was designed to achieve at least 80% power, using n 1⁄4 123 per group with an effect size of at least 0.36|Adjusted difference in mean change|-1.76||||0.09|TWO_SIDED|95.0|-3.8|0.3||a priori threshold was p\<0.05|ANCOVA|||Intent to Treat analysis with Last Observation Carried Forward.||0.3|-3.8|0.09
72364135|NCT00001959|144240045|SUPERIORITY_OR_OTHER||||||<|0.01||95.0|||||Wilcoxon (Mann-Whitney)|||H0: GFR Decrease during baseline period and treatment period are same||||<0.01
72431569|NCT00924560|144375040|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.14|||||TWO_SIDED|95.0|-0.32|0.03||||||Comparison of Change from Baseline to Month 12. ANCOVA model with treatment as a fixed effect and chronological age, body weight, and Baseline value as covariates.||0.03|-0.32|
72431570|NCT00924560|144375041|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0|||||TWO_SIDED|95.0|-0.01|0.0||||||Comparison of Change from Baseline to Month 6. ANCOVA model with treatment as a fixed effect and chronological age, body weight, and Baseline value as covariates.||0.00|-0.01|
72431571|NCT00924560|144375041|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0|||||TWO_SIDED|95.0|-0.01|0.0||||||Comparison of Change from Baseline to Month 6. ANCOVA model with treatment as a fixed effect and chronological age, body weight, and Baseline value as covariates.||0.00|-0.01|
72364136|NCT00001959|144240046|SUPERIORITY_OR_OTHER|||||||0.16||95.0|||||Kruskal-Wallis|||H0: Proteinuria during baseline and treatment periods are same||||0.16
72364137|NCT05386329|144240082|SUPERIORITY|Comparison of mid-treatment to end-of-treatment|Mean Difference (Final Values)|1.0308|STANDARD_ERROR_OF_MEAN|0.5485|=|0.0719|TWO_SIDED|95.0|-0.09883|2.1605||The a priori threshold for statistical significance was alpha=.05.|Mixed Models Analysis|Repeated measures were modeled with an unstructured covariance matrix.|The effect is presented as the therapist-guided smartphone-delivered CBT midpoint (week 4) CSQ-8 score compared to the end-point (week 8) CSQ-8 score.|Null hypothesis: there is no significant difference in CSQ-8 total scores between midpoint (week 4) and end-of-treatment (week 8).||2.1605|-0.09883|=.0719
72364138|NCT05386329|144240083|SUPERIORITY|Comparison of mid-treatment (week 4) to baseline|Mean Difference (Final Values)|0.4296|STANDARD_ERROR_OF_MEAN|0.8857|=|0.6316|TWO_SIDED|95.0|-1.3884|2.2475||The a priori threshold for statistical significance was alpha=.05.|Mixed Models Analysis|Repeated measures were modeled with an unstructured covariance matrix.|The effect is presented as the therapist-guided smartphone-delivered CBT midpoint (week 4) CEQ credibility score compared to the baseline (week 0) CEQ credibility score.|Null hypothesis: there is no significant difference in treatment credibility total scores between baseline (week 0) and midpoint (week 4).||2.2475|-1.3884|=.6316
72364139|NCT05386329|144240084|SUPERIORITY|Comparison of mid-treatment (week 4) to baseline.|Mean Difference (Final Values)|1.1512|STANDARD_ERROR_OF_MEAN|0.9213|=|0.2225|TWO_SIDED|95.0|-0.7422|3.0446||The a priori threshold for statistical significance was alpha=.05.|Mixed Models Analysis|Repeated measures were modeled with an unstructured covariance matrix.|The effect is presented as the therapist-guided smartphone-delivered CBT midpoint (week 4) CEQ expectancy scores compared to the baseline (week 0) CEQ expectancy scores.|Null hypothesis: there is no significant difference in treatment expectancy total scores between baseline (week 0) and midpoint (week 4).||3.0446|-0.7422|=.2225
72364140|NCT05386329|144240086|SUPERIORITY|Comparison of post-treatment (week 8) to mid-treatment (week 4)|Wilcoxon Z|0.2712|||=|0.7873|TWO_SIDED|||||The a priori threshold for statistical significance was alpha=.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis: There is no significant difference in treatment utilization between midpoint (week 4) and end of treatment (week 8).||||=.7873
72364141|NCT05386329|144240087|SUPERIORITY|Pre-post comparison|Mean Difference (Final Values)|-7.8424|STANDARD_ERROR_OF_MEAN|1.2858|<|0.0001|TWO_SIDED|95.0|-10.4944|-5.1903||The p-value was not adjusted for multiple comparisons because this was the pre-specified primary endpoint comparison. The a priori threshold for statistical significance was alpha=.05.|Mixed Models Analysis|Repeated measures were modeled with an unstructured covariance matrix.|The effect is presented as the therapist-guided smartphone-delivered CBT end of treatment (week 8) HAM-D score compared to the baseline (week 0) HAM-D score.|Null hypothesis: there is no significant difference in HAM-D total scores between baseline (week 0) and end of treatment (week 8).||-5.1903|-10.4944|<.0001
72364142|NCT05386329|144240088|SUPERIORITY|Pre-post comparison|Mean Difference (Final Values)|-9.9409|STANDARD_ERROR_OF_MEAN|1.7329|<|0.0001|TWO_SIDED|95.0|-13.5043|-6.3776||The p-value was not adjusted for multiple comparisons because this was the pre-specified secondary outcome that addresses complementary aspects of the patient experience. The a priori threshold for statistical significance was alpha=.05.|Mixed Models Analysis|Repeated measures were modeled with an unstructured covariance matrix.|The effect is presented as the therapist-guided smartphone-delivered CBT end of treatment (week 8) WSAS scores compared to the baseline (week 0) WSAS scores.|Null hypothesis: there is no significant difference in WSAS total scores between baseline (week 0) and end of treatment (week 8).||-6.3776|-13.5043|<.0001
72364143|NCT05386329|144240089|SUPERIORITY|Pre-post comparison|Mean Difference (Final Values)|21.5463|STANDARD_ERROR_OF_MEAN|3.4152|<|0.0001|TWO_SIDED|95.0|14.512|28.5806||The p-value was not adjusted for multiple comparisons because this was a pre-specified secondary outcome assessing a complementary aspect of the patient experience. The a priori threshold for statistical significance was alpha=.05.|Mixed Models Analysis|Repeated measures were modeled with an unstructured covariance matrix.|The effect is presented as the therapist-guided smartphone-delivered CBT end of treatment (week 8) Q-LES-Q-SF percent scores compared to the baseline (week 0) Q-LES-Q-SF percent scores.|Null hypothesis: there is no significant difference in Q-LES-Q-SF total scores between baseline (week 0) and end of treatment (week 8).||28.5806|14.5120|<.0001
72364144|NCT00737672|144240109|SUPERIORITY_OR_OTHER|||||||0.53|||||||Log Rank|||||||0.530
72364145|NCT00737672|144240112|SUPERIORITY_OR_OTHER|||||||0.475|||||||Log Rank|||||||0.475
72364146|NCT00737672|144240115|SUPERIORITY_OR_OTHER|||||||0.008||||||P-value was calculated using Kaplan-Meier methodology with 24-month follow-up data.|Log Rank|||||||0.008
72364147|NCT00737672|144240116|NON_INFERIORITY_OR_EQUIVALENCE|One-sided test of non-inferior proportions with delta = 0.15.|||||<|0.001|||||||Z-test|One-sided.||||||<0.001
72364148|NCT00737672|144240117|SUPERIORITY_OR_OTHER|||||||0.035|||||||Log Rank|||||||0.035
72364149|NCT00737672|144240120|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|Two-tailed.||||||1.000
72364150|NCT00737672|144240121|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Fisher Exact|Two-tailed.||||||<0.001
72364151|NCT00737672|144240122|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Fisher Exact|Two-tailed.||||||<0.001
72364152|NCT03818256|144240166|SUPERIORITY||Least Squares Mean Difference|0.11||||0.8511|TWO_SIDED|95.0|-1.03|1.24|||Mixed Models Analysis|||||1.24|-1.03|0.8511
72364153|NCT03818256|144240170|SUPERIORITY||Odds Ratio (OR)|0.82||||0.8169|TWO_SIDED|95.0|0.15|4.474|||Regression, Logistic|||||4.474|0.150|0.8169
72431572|NCT00924560|144375041|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0|||||TWO_SIDED|95.0|-0.01|0.0||||||Comparison of Change from Baseline to Month 12. ANCOVA model with treatment as a fixed effect and chronological age, body weight, and Baseline value as covariates.||-0.00|-0.01|
72364154|NCT03818256|144240171|SUPERIORITY||Location shift|0.175||||0.9285|TWO_SIDED|95.0|-2.86|2.78|||Wilcoxon rank-sum test|||||2.780|-2.860|0.9285
72364155|NCT03818256|144240172|SUPERIORITY||Least squares mean difference|0.007||||0.5669|TWO_SIDED|95.0|-0.018|0.033|||Mixed Models Analysis|||||0.033|-0.018|0.5669
72364156|NCT05565742|144240222|SUPERIORITY||LS Mean difference (Final Values)|-40.8|STANDARD_ERROR_OF_MEAN|8.82|<|0.001|TWO_SIDED|95.0|-55.8|-20.6|||Mixed Models Analysis|||||-20.6|-55.8|<0.001
72364157|NCT05565742|144240222|SUPERIORITY||LS Mean difference (Final Values)|-75.2|STANDARD_ERROR_OF_MEAN|3.01|<|0.001|TWO_SIDED|95.0|-80.4|-68.5|||Mixed Models Analysis|||||-68.5|-80.4|<0.001
72364158|NCT05565742|144240222|SUPERIORITY||LS Mean difference (Final Values)|-93.9|STANDARD_ERROR_OF_MEAN|0.65|<|0.001|TWO_SIDED|95.0|-95.1|-92.5|||Mixed Models Analysis|||||-92.5|-95.1|<0.001
72364159|NCT05565742|144240223|SUPERIORITY||LS Mean difference (Final Values)|-38.9|STANDARD_ERROR_OF_MEAN|9.43||0.002|TWO_SIDED|95.0|-54.9|-17.2|||Mixed Models Analysis|||||-17.2|-54.9|0.002
72364160|NCT05565742|144240223|SUPERIORITY||LS Mean difference (Final Values)|-77.4|STANDARD_ERROR_OF_MEAN|2.83|<|0.001|TWO_SIDED|95.0|-82.4|-71.1|||Mixed Models Analysis|||||-71.1|-82.4|<0.001
72364161|NCT05565742|144240223|SUPERIORITY||LS Mean difference (Final Values)|-95.0|STANDARD_ERROR_OF_MEAN|0.64|<|0.001|TWO_SIDED|95.0|-96.1|-93.6|||Mixed Models Analysis|||||-93.6|-96.1|<0.001
72364162|NCT05565742|144240223|SUPERIORITY||LS Mean difference (Final Values)|-76.8|STANDARD_ERROR_OF_MEAN|2.94|<|0.001|TWO_SIDED|95.0|-81.9|-70.2|||Mixed Models Analysis|||||-70.2|-81.9|<0.001
72364163|NCT05565742|144240224|SUPERIORITY||Odds Ratio (OR)|112.03||||0.001|TWO_SIDED|95.0|6.35|1975.13|||Regression, Logistic|||Lp(a) \<125 nmol/L: Day 60||1975.13|6.35|0.001
72364164|NCT05565742|144240224|SUPERIORITY||Odds Ratio (OR)|2762.52|||<|0.001|TWO_SIDED|95.0|142.74|53463.34|||Regression, Logistic|||Lp(a) \<125 nmol/L: Day 60||53463.34|142.74|<0.001
72364165|NCT05565742|144240224|SUPERIORITY||Odds Ratio (OR)|50904.09|||<|0.001|TWO_SIDED|95.0|1700.95|1523398.1|||Regression, Logistic|||Lp(a) \<125 nmol/L: Day 60||1523398.10|1700.95|<0.001
72364166|NCT05565742|144240224|SUPERIORITY||Odds Ratio (OR)|27.94||||0.026|TWO_SIDED|95.0|1.48|527.74|||Regression, Logistic|||Lp(a) \<125 nmol/L: Day 180||527.74|1.48|0.026
72364167|NCT05565742|144240224|SUPERIORITY||Odds Ratio (OR)|309.36|||<|0.001|TWO_SIDED|95.0|17.99|5320.81|||Regression, Logistic|||Lp(a) \<125 nmol/L: Day 180||5320.81|17.99|<0.001
72364168|NCT05565742|144240224|SUPERIORITY||Odds Ratio (OR)|3060.16|||<|0.001|TWO_SIDED|95.0|166.84|56127.55|||Regression, Logistic|||Lp(a) \<125 nmol/L: Day 180||56127.55|166.84|<0.001
72364169|NCT05565742|144240224|SUPERIORITY||Odds Ratio (OR)|32.91||||0.021|TWO_SIDED|95.0|1.7|635.94|||Regression, Logistic|||Lp(a) \<75 nmol/L: Day 60||635.94|1.70|0.021
72364170|NCT05565742|144240224|SUPERIORITY||Odds Ratio (OR)|579.62|||<|0.001|TWO_SIDED|95.0|31.48|10673.41|||Regression, Logistic|||Lp(a) \<75 nmol/L: Day 60||10673.41|31.48|<0.001
72364171|NCT05565742|144240224|SUPERIORITY||Odds Ratio (OR)|14659.81|||<|0.001|TWO_SIDED|95.0|646.35|332498.98|||Regression, Logistic|||Lp(a) \<75 nmol/L: Day 60||332498.98|646.35|<0.001
72364172|NCT05565742|144240224|SUPERIORITY||Odds Ratio (OR)|15.94||||0.071|TWO_SIDED|95.0|0.79|321.21|||Regression, Logistic|||Lp(a) \<75 nmol/L: Day 180||321.21|0.79|0.071
72364173|NCT05565742|144240224|SUPERIORITY||Odds Ratio (OR)|86.32||||0.002|TWO_SIDED|95.0|5.07|1468.36|||Regression, Logistic|||Lp(a) \<75 nmol/L: Day 180||1468.36|5.07|0.002
72364174|NCT05565742|144240224|SUPERIORITY||Odds Ratio (OR)|956.84|||<|0.001|TWO_SIDED|95.0|55.75|16422.76|||Regression, Logistic|||Lp(a) \<75 nmol/L: Day 180||16422.76|55.75|<0.001
72364175|NCT05565742|144240225|SUPERIORITY||Odds Ratio (OR)|32.05|||<|0.001|TWO_SIDED|95.0|5.36|191.58|||Regression, Logistic|||Lp(a) \<125 nmol/L: Day 240||191.58|5.36|<0.001
72364176|NCT05565742|144240225|SUPERIORITY||Odds Ratio (OR)|602.39|||<|0.001|TWO_SIDED|95.0|95.36|3805.22|||Regression, Logistic|||Lp(a) \<125 nmol/L: Day 240||3805.22|95.36|<0.001
72364177|NCT05565742|144240225|SUPERIORITY||Odds Ratio (OR)|6953.37|||<|0.001|TWO_SIDED|95.0|527.56|91646.24|||Regression, Logistic|||Lp(a) \<125 nmol/L: Day 240||91646.24|527.56|<0.001
72364178|NCT05565742|144240225|SUPERIORITY||Odds Ratio (OR)|347.76|||<|0.001|TWO_SIDED|95.0|57.46|2104.62|||Regression, Logistic|||Lp(a) \<125 nmol/L: Day 240||2104.62|57.46|<0.001
72364179|NCT05565742|144240225|SUPERIORITY||Odds Ratio (OR)|54.99||||0.007|TWO_SIDED|95.0|2.98|1015.84|||Regression, Logistic|||Lp(a) \<125 nmol/L: Day 360||1015.84|2.98|0.007
72364180|NCT05565742|144240225|SUPERIORITY||Odds Ratio (OR)|363.15|||<|0.001|TWO_SIDED|95.0|20.83|6332.68|||Regression, Logistic|||Lp(a) \<125 nmol/L: Day 360||6332.68|20.83|<0.001
72364181|NCT05565742|144240225|SUPERIORITY||Odds Ratio (OR)|2953.53|||<|0.001|TWO_SIDED|95.0|150.95|57790.71|||Regression, Logistic|||Lp(a) \<125 nmol/L: Day 360||57790.71|150.95|<0.001
72364182|NCT05565742|144240225|SUPERIORITY||Odds Ratio (OR)|375.16|||<|0.001|TWO_SIDED|95.0|21.46|6571.66|||Regression, Logistic|||Lp(a) \<125 nmol/L: Day 360||6571.66|21.46|<0.001
72364183|NCT05565742|144240225|SUPERIORITY||Odds Ratio (OR)|16.43||||0.068|TWO_SIDED|95.0|0.81|331.69|||Regression, Logistic|||Lp(a) \<125 nmol/L: Day 540||331.69|0.81|0.068
72364184|NCT05565742|144240225|SUPERIORITY||Odds Ratio (OR)|84.97||||0.002|TWO_SIDED|95.0|4.99|1447.48|||Regression, Logistic|||Lp(a) \<125 nmol/L: Day 540||1447.48|4.99|0.002
72364185|NCT05565742|144240225|SUPERIORITY||Odds Ratio (OR)|594.66|||<|0.001|TWO_SIDED|95.0|33.99|10405.09|||Regression, Logistic|||Lp(a) \<125 nmol/L: Day 540||10405.09|33.99|<0.001
72364186|NCT05565742|144240225|SUPERIORITY||Odds Ratio (OR)|110.17||||0.001|TWO_SIDED|95.0|6.47|1875.77|||Regression, Logistic|||Lp(a) \<125 nmol/L: Day 540||1875.77|6.47|0.001
72364187|NCT05565742|144240225|SUPERIORITY||Odds Ratio (OR)|11.61||||0.01|TWO_SIDED|95.0|1.81|74.29|||Regression, Logistic|||Lp(a) \<75 nmol/L: Day 240||74.29|1.81|0.010
72364188|NCT05565742|144240225|SUPERIORITY||Odds Ratio (OR)|233.25|||<|0.001|TWO_SIDED|95.0|39.92|1362.79|||Regression, Logistic|||Lp(a) \<75 nmol/L: Day 240||1362.79|39.92|<0.001
72364189|NCT05565742|144240225|SUPERIORITY||Odds Ratio (OR)|3087.58|||<|0.001|TWO_SIDED|95.0|331.26|28778.1|||Regression, Logistic|||Lp(a) \<75 nmol/L: Day 240||28778.10|331.26|<0.001
72364190|NCT05565742|144240225|SUPERIORITY||Odds Ratio (OR)|144.58|||<|0.001|TWO_SIDED|95.0|25.2|829.42|||Regression, Logistic|||Lp(a) \<75 nmol/L: Day 240||829.42|25.20|<0.001
72364191|NCT05565742|144240225|SUPERIORITY||Odds Ratio (OR)|11.16||||0.125|TWO_SIDED|95.0|0.51|243.85|||Regression, Logistic|||Lp(a) \<75 nmol/L: Day 360||243.85|0.51|0.125
72364192|NCT05565742|144240225|SUPERIORITY||Odds Ratio (OR)|148.3|||<|0.001|TWO_SIDED|95.0|8.64|2546.89|||Regression, Logistic|||Lp(a) \<75 nmol/L: Day 360||2546.89|8.64|<0.001
72364193|NCT05565742|144240225|SUPERIORITY||Odds Ratio (OR)|1431.38|||<|0.001|TWO_SIDED|95.0|77.76|26349.86|||Regression, Logistic|||Lp(a) \<75 nmol/L: Day 360||26349.86|77.76|<0.001
72364194|NCT05565742|144240225|SUPERIORITY||Odds Ratio (OR)|147.78|||<|0.001|TWO_SIDED|95.0|8.6|2538.95|||Regression, Logistic|||Lp(a) \<75 nmol/L: Day 360||2538.95|8.60|<0.001
72364195|NCT05565742|144240225|SUPERIORITY||Odds Ratio (OR)|1.99||||0.733|TWO_SIDED|95.0|0.04|104.02|||Regression, Logistic|||Lp(a) \<75 nmol/L: Day 540||104.02|0.04|0.733
72364196|NCT05565742|144240225|SUPERIORITY||Odds Ratio (OR)|34.28||||0.015|TWO_SIDED|95.0|1.98|594.46|||Regression, Logistic|||Lp(a) \<75 nmol/L: Day 540||594.46|1.98|0.015
72364197|NCT05565742|144240225|SUPERIORITY||Odds Ratio (OR)|159.77|||<|0.001|TWO_SIDED|95.0|9.4|2716.42|||Regression, Logistic|||Lp(a) \<75 nmol/L: Day 540||2716.42|9.40|<0.001
72364198|NCT05565742|144240225|SUPERIORITY||Odds Ratio (OR)|37.98||||0.013|TWO_SIDED|95.0|2.19|659.75|||Regression, Logistic|||Lp(a) \<75 nmol/L: Day 540||659.75|2.19|0.013
72431573|NCT00924560|144375041|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0|||||TWO_SIDED|95.0|-0.01|0.0||||||Comparison of Change from Baseline to Month 12. ANCOVA model with treatment as a fixed effect and chronological age, body weight, and Baseline value as covariates.||-0.00|-0.01|
72431574|NCT00924560|144375042|SUPERIORITY_OR_OTHER||LS Mean Difference|-5.48|||||TWO_SIDED|95.0|-23.57|12.61||||||Comparison of Change from Baseline to Month 6. ANCOVA model with treatment as a fixed effect and chronological age, body weight, and Baseline value as covariates.||12.61|-23.57|
72431575|NCT00924560|144375042|SUPERIORITY_OR_OTHER||LS Mean Difference|-7.55|||||TWO_SIDED|95.0|-25.65|10.55||||||Comparison of Change from Baseline to Month 6. ANCOVA model with treatment as a fixed effect and chronological age, body weight, and Baseline value as covariates.||10.55|-25.65|
72431576|NCT00924560|144375042|SUPERIORITY_OR_OTHER||LS Mean Difference|-12.09|||||TWO_SIDED|95.0|-34.99|10.81||||||Comparison of Change from Baseline to Month 12. ANCOVA model with treatment as a fixed effect and chronological age, body weight, and Baseline value as covariates.||10.81|-34.99|
72431577|NCT00924560|144375042|SUPERIORITY_OR_OTHER||LS Mean Difference|-21.17|||||TWO_SIDED|95.0|-44.08|1.74||||||Comparison of Change from Baseline to Month 12. ANCOVA model with treatment as a fixed effect and chronological age, body weight, and Baseline value as covariates.||1.74|-44.08|
72431578|NCT02909101|144375089|SUPERIORITY|||||||0.039|||||||ANCOVA|ANCOVAs were 2 (Arm) by 2 (Time). Covariates were age, WTAR standard score, and number of games improved (as a proxy of intervention engagement).||Estimated marginal means, adjusted for covariates in the model, are reported. The p-value reported is for the Arm by Time interaction effect.||||0.039
72431579|NCT02909101|144375090|SUPERIORITY|||||||0.054|||||||ANCOVA|ANCOVAs were 2 (Arm) by 2 (Time). Covariates were age, WTAR standard score, and number of games improved (as a proxy of intervention engagement).||Estimated marginal means, adjusted for covariates in the model, are reported. The p-value reported is for the Arm by Time interaction effect.||||0.054
72431580|NCT02909101|144375091|OTHER|||||||0.744|||||||t-test, 2 sided|||To determine acceptability, we examined whether mean ratings for both arms were above 3.5, and we also examined whether there was any difference between arms.||||0.744
72431581|NCT02909101|144375092|OTHER|||||||0.719|||||||t-test, 2 sided|||To determine acceptability in terms of helpfulness, we examined whether mean ratings for both arms were above 3.5, and we also examined whether there was any difference between arms.||||0.719
72431582|NCT02909101|144375093|SUPERIORITY|||||||0.337|||||||ANCOVA|ANCOVAs were 2 (Arm) by 2 (Time). Covariates were age, WTAR standard score, and number of games improved (as a proxy of intervention engagement).||Estimated marginal means, adjusted for covariates in the model, are reported. The p-value reported is for the Arm by Time interaction effect.||||0.337
72431583|NCT02909101|144375094|SUPERIORITY|||||||0.025|||||||ANCOVA|ANCOVAs were 2 (Arm) by 2 (Time). Covariates were age, WTAR standard score, and number of games improved (as a proxy of intervention engagement).||Estimated marginal means, adjusted for covariates in the model, are reported. The p-value reported is for the Arm by Time interaction effect.||||0.025
72431584|NCT02909101|144375095|SUPERIORITY|||||||0.133|||||||ANCOVA|ANCOVAs were 2 (Arm) by 2 (Time). Covariates were age, WTAR standard score, and number of games improved (as a proxy of intervention engagement).||Estimated marginal means, adjusted for covariates in the model, are reported. The p-value reported is for the Arm by Time interaction effect.||||0.133
72431585|NCT01290094|144375100|SUPERIORITY_OR_OTHER||||||<|0.0005|TWO_SIDED|||||P-value for percent change from baseline was from a paired samples t-test.|Paired t-test|||||||<0.0005
72431586|NCT01290094|144375101|SUPERIORITY_OR_OTHER||||||<|0.0005|TWO_SIDED|||||P-value for percent change from baseline was from a paired samples t-test.|Paired t-test|||||||<0.0005
72431587|NCT01290094|144375102|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED|||||P-value for percent change from baseline was from a paired samples t-test.|Paired t-test|||||||0.001
72431588|NCT01290094|144375103|SUPERIORITY_OR_OTHER|||||||0.056|TWO_SIDED|||||P-value for percent change from baseline was from a paired samples t-test.|Paired t-test|||||||0.056
72431589|NCT01290094|144375104|SUPERIORITY_OR_OTHER||||||<|0.0005|TWO_SIDED|||||Month 12: P-value for percent change from baseline was from a Wilcoxon signed rank test.|Wilcoxon signed rank test|||||||<0.0005
72431590|NCT01290094|144375104|SUPERIORITY_OR_OTHER||||||<|0.0005|TWO_SIDED|||||Month 24: P-value for percent change from baseline was from a Wilcoxon signed rank test.|Wilcoxon signed rank test|||||||<0.0005
72431591|NCT01290094|144375105|SUPERIORITY_OR_OTHER||||||<|0.0005|TWO_SIDED|||||Month 12: P-value for percent change from baseline was from a paired samples t-test.|Paired t-test|||||||<0.0005
72364199|NCT05565742|144240226|SUPERIORITY||LS Mean difference (Final Values)|-47.4|STANDARD_ERROR_OF_MEAN|7.29|<|0.001|TWO_SIDED|95.0|-59.9|-30.9|||Mixed Models Analysis|||Baseline to Day 60||-30.9|-59.9|<0.001
72364200|NCT05565742|144240226|SUPERIORITY||LS Mean difference (Final Values)|-80.9|STANDARD_ERROR_OF_MEAN|2.16|<|0.001|TWO_SIDED|95.0|-84.7|-76.1|||Mixed Models Analysis|||Baseline to Day 60||-76.1|-84.7|<0.001
72364201|NCT05565742|144240226|SUPERIORITY||LS Mean difference (Final Values)|-95.5|STANDARD_ERROR_OF_MEAN|0.45|<|0.001|TWO_SIDED|95.0|-96.3|-94.5|||Mixed Models Analysis|||Baseline to Day 60||-94.5|-96.3|<0.001
72364202|NCT05565742|144240226|SUPERIORITY||LS Mean difference (Final Values)|-95.5|STANDARD_ERROR_OF_MEAN|0.45|<|0.001|TWO_SIDED|95.0|-96.3|-94.5|||Mixed Models Analysis|||Baseline to Day 60||-94.5|-96.3|<0.001
72364203|NCT05565742|144240226|SUPERIORITY||LS Mean difference (Final Values)|-31.9|STANDARD_ERROR_OF_MEAN|11.1||0.019|TWO_SIDED|95.0|-50.6|-6.2|||Mixed Models Analysis|||Baseline to Day 180||-6.2|-50.6|0.019
72364204|NCT05565742|144240226|SUPERIORITY||LS Mean difference (Final Values)|-66.0|STANDARD_ERROR_OF_MEAN|4.52|<|0.001|TWO_SIDED|95.0|-73.8|-55.9|||Mixed Models Analysis|||Baseline to Day 180||-55.9|-73.8|<0.001
72364205|NCT05565742|144240226|SUPERIORITY||LS Mean difference (Final Values)|-90.7|STANDARD_ERROR_OF_MEAN|1.09|<|0.001|TWO_SIDED|95.0|-92.6|-88.3|||Mixed Models Analysis|||Baseline to Day 180||-88.3|-92.6|<0.001
72364206|NCT05565742|144240226|SUPERIORITY||LS Mean difference (Final Values)|-90.7|STANDARD_ERROR_OF_MEAN|1.09|<|0.001|TWO_SIDED|95.0|-92.6|-88.3|||Mixed Models Analysis|||Baseline to Day 180||-88.3|-92.6|<0.001
72364207|NCT05565742|144240226|SUPERIORITY||LS Mean difference (Final Values)|-47.3|STANDARD_ERROR_OF_MEAN|8.25|<|0.001|TWO_SIDED|95.0|-61.3|-28.3|||Mixed Models Analysis|||Baseline to Day 240||-28.3|-61.3|<0.001
72364208|NCT05565742|144240226|SUPERIORITY||LS Mean difference (Final Values)|-84.7|STANDARD_ERROR_OF_MEAN|1.95|<|0.001|TWO_SIDED|95.0|-88.1|-80.3|||Mixed Models Analysis|||Baseline to Day 240||-80.3|-88.1|<0.001
72364209|NCT05565742|144240226|SUPERIORITY||LS Mean difference (Final Values)|-96.8|STANDARD_ERROR_OF_MEAN|0.38|<|0.001|TWO_SIDED|95.0|-97.4|-95.9|||Mixed Models Analysis|||Baseline to Day 240||-95.9|-97.4|<0.001
72364210|NCT05565742|144240226|SUPERIORITY||LS Mean difference (Final Values)|-84.7|STANDARD_ERROR_OF_MEAN|1.78|<|0.001|TWO_SIDED|95.0|-87.9|-80.8|||Mixed Models Analysis|||Baseline to Day 240||-80.8|-87.9|<0.001
72364211|NCT05565742|144240226|SUPERIORITY||LS Mean difference (Final Values)|-30.2|STANDARD_ERROR_OF_MEAN|11.45||0.029|TWO_SIDED|95.0|-49.4|-3.6|||Mixed Models Analysis|||Baseline to Day 360||-3.6|-49.4|0.029
72364212|NCT05565742|144240226|SUPERIORITY||LS Mean difference (Final Values)|-67.4|STANDARD_ERROR_OF_MEAN|4.35|<|0.001|TWO_SIDED|95.0|-74.9|-57.6|||Mixed Models Analysis|||Baseline to Day 360||-57.6|-74.9|<0.001
72364213|NCT05565742|144240226|SUPERIORITY||LS Mean difference (Final Values)|-91.0|STANDARD_ERROR_OF_MEAN|1.11|<|0.001|TWO_SIDED|95.0|-92.9|-88.5|||Mixed Models Analysis|||Baseline to Day 360||-88.5|-92.9|<0.001
72364214|NCT05565742|144240226|SUPERIORITY||LS Mean difference (Final Values)|-67.8|STANDARD_ERROR_OF_MEAN|3.96|<|0.001|TWO_SIDED|95.0|-74.8|-59.0|||Mixed Models Analysis|||Baseline to Day 360||-59.0|-74.8|<0.001
72364215|NCT05565742|144240226|SUPERIORITY||LS Mean difference (Final Values)|-19.7|STANDARD_ERROR_OF_MEAN|10.45||0.093|TWO_SIDED|95.0|-37.8|3.7|||Mixed Models Analysis|||Baseline to Day 540||3.7|-37.8|0.093
72364216|NCT05565742|144240226|SUPERIORITY||LS Mean difference (Final Values)|-45.8|STANDARD_ERROR_OF_MEAN|5.76|<|0.001|TWO_SIDED|95.0|-56.0|-33.2|||Mixed Models Analysis|||Baseline to Day 540||-33.2|-56.0|<0.001
72364217|NCT05565742|144240226|SUPERIORITY||LS Mean difference (Final Values)|-74.2|STANDARD_ERROR_OF_MEAN|2.59|<|0.001|TWO_SIDED|95.0|-78.8|-68.5|||Mixed Models Analysis|||Baseline to Day 540||-68.5|-78.8|<0.001
72364218|NCT05565742|144240226|SUPERIORITY||LS Mean difference (Final Values)|-53.4|STANDARD_ERROR_OF_MEAN|4.67|<|0.001|TWO_SIDED|95.0|-61.7|-43.3|||Mixed Models Analysis|||Baseline to Day 540||-43.3|-61.7|<0.001
72364219|NCT05565742|144240227|SUPERIORITY||LS Mean difference (Final Values)|-10.4|STANDARD_ERROR_OF_MEAN|3.74||0.01|TWO_SIDED|95.0|-17.5|-2.6|||Mixed Models Analysis|||Baseline to Day 60||-2.6|-17.5|0.010
72364220|NCT05565742|144240227|SUPERIORITY||LS Mean difference (Final Values)|-11.9|STANDARD_ERROR_OF_MEAN|3.02|<|0.001|TWO_SIDED|95.0|-17.7|-5.8|||Mixed Models Analysis|||Baseline to Day 60||-5.8|-17.7|<0.001
72364221|NCT05565742|144240227|SUPERIORITY||LS Mean difference (Final Values)|-14.1|STANDARD_ERROR_OF_MEAN|2.59|<|0.001|TWO_SIDED|95.0|-19.0|-8.8|||Mixed Models Analysis|||Baseline to Day 60||-8.8|-19.0|<0.001
72364222|NCT05565742|144240227|SUPERIORITY||LS Mean difference (Final Values)|-14.1|STANDARD_ERROR_OF_MEAN|2.59|<|0.001|TWO_SIDED|95.0|-19.0|-8.8|||Mixed Models Analysis|||Baseline to Day 60||-8.8|-19.0|<0.001
72364223|NCT05565742|144240227|SUPERIORITY||LS Mean difference (Final Values)|-8.2|STANDARD_ERROR_OF_MEAN|4.27||0.068|TWO_SIDED|95.0|-16.2|0.6|||Mixed Models Analysis|||Baseline to Day 180||0.6|-16.2|0.068
72364224|NCT05565742|144240227|SUPERIORITY||LS Mean difference (Final Values)|-10.7|STANDARD_ERROR_OF_MEAN|3.4||0.003|TWO_SIDED|95.0|-17.1|-3.8|||Mixed Models Analysis|||Baseline to Day 180||-3.8|-17.1|0.003
72364225|NCT05565742|144240227|SUPERIORITY||LS Mean difference (Final Values)|-13.7|STANDARD_ERROR_OF_MEAN|2.89|<|0.001|TWO_SIDED|95.0|-19.3|-7.9|||Mixed Models Analysis|||Baseline to Day 180||-7.9|-19.3|<0.001
72364226|NCT05565742|144240227|SUPERIORITY||LS Mean difference (Final Values)|-13.7|STANDARD_ERROR_OF_MEAN|2.89|<|0.001|TWO_SIDED|95.0|-19.3|-7.9|||Mixed Models Analysis|||Baseline to Day 180||-7.9|-19.3|<0.001
72364227|NCT05565742|144240227|SUPERIORITY||LS Mean difference (Final Values)|-9.2|STANDARD_ERROR_OF_MEAN|3.93||0.026|TWO_SIDED|95.0|-16.7|-1.2|||Mixed Models Analysis|||Baseline to Day 240||-1.2|-16.7|0.026
72364228|NCT05565742|144240227|SUPERIORITY||LS Mean difference (Final Values)|-15.4|STANDARD_ERROR_OF_MEAN|2.99|<|0.001|TWO_SIDED|95.0|-21.1|-9.3|||Mixed Models Analysis|||Baseline to Day 240||-9.3|-21.1|<0.001
72364229|NCT05565742|144240227|SUPERIORITY||LS Mean difference (Final Values)|-15.5|STANDARD_ERROR_OF_MEAN|2.9|<|0.001|TWO_SIDED|95.0|-21.0|-9.6|||Mixed Models Analysis|||Baseline to Day 240||-9.6|-21.0|<0.001
72364230|NCT05565742|144240227|SUPERIORITY||LS Mean difference (Final Values)|-10.6|STANDARD_ERROR_OF_MEAN|3.03|<|0.001|TWO_SIDED|95.0|-16.3|-4.4|||Mixed Models Analysis|||Baseline to Day 240||-4.4|-16.3|<0.001
72364231|NCT05565742|144240227|SUPERIORITY||LS Mean difference (Final Values)|-7.0|STANDARD_ERROR_OF_MEAN|4.21||0.111|TWO_SIDED|95.0|-14.9|1.7|||Mixed Models Analysis|||Baseline to Day 360||1.7|-14.9|0.111
72364232|NCT05565742|144240227|SUPERIORITY||LS Mean difference (Final Values)|-12.0|STANDARD_ERROR_OF_MEAN|3.25|<|0.001|TWO_SIDED|95.0|-18.1|-5.3|||Mixed Models Analysis|||Baseline to Day 360||-5.3|-18.1|<0.001
72364233|NCT05565742|144240227|SUPERIORITY||LS Mean difference (Final Values)|-14.1|STANDARD_ERROR_OF_MEAN|3.11|<|0.001|TWO_SIDED|95.0|-20.0|-7.8|||Mixed Models Analysis|||Baseline to Day 360||-7.8|-20.0|<0.001
72364234|NCT05565742|144240227|SUPERIORITY||LS Mean difference (Final Values)|-8.6|STANDARD_ERROR_OF_MEAN|3.3||0.013|TWO_SIDED|95.0|-14.9|-1.9|||Mixed Models Analysis|||400 mg LY3819469, Placebo||-1.9|-14.9|0.013
72364235|NCT05565742|144240227|SUPERIORITY||LS Mean difference (Final Values)|-2.8|STANDARD_ERROR_OF_MEAN|4.2||0.51|TWO_SIDED|95.0|-10.7|5.8|||Mixed Models Analysis|||Baseline to Day 540||5.8|-10.7|0.510
72364236|NCT05565742|144240227|SUPERIORITY||LS Mean difference (Final Values)|-4.7|STANDARD_ERROR_OF_MEAN|3.35||0.173|TWO_SIDED|95.0|-11.1|2.1|||Mixed Models Analysis|||Baseline to Day 540||2.1|-11.1|0.173
72364237|NCT05565742|144240227|SUPERIORITY||LS Mean difference (Final Values)|-12.9|STANDARD_ERROR_OF_MEAN|3.01|<|0.001|TWO_SIDED|95.0|-18.6|-6.8|||Mixed Models Analysis|||Baseline to Day 540||-6.8|-18.6|<0.001
72364238|NCT05565742|144240227|SUPERIORITY||LS Mean difference (Final Values)|-5.0|STANDARD_ERROR_OF_MEAN|3.27||0.139|TWO_SIDED|95.0|-11.2|1.7|||Mixed Models Analysis|||Baseline to Day 540||1.7|-11.2|0.139
72364239|NCT05565742|144240228|SUPERIORITY||LS Mean difference (Final Values)|-17.1|STANDARD_ERROR_OF_MEAN|16.71||0.353|TWO_SIDED|95.0|-44.3|23.3|||Mixed Models Analysis|||Baseline to Day 60||23.3|-44.3|0.353
72364240|NCT05565742|144240228|SUPERIORITY||LS Mean difference (Final Values)|-2.0|STANDARD_ERROR_OF_MEAN|15.84||0.902|TWO_SIDED|95.0|-28.7|34.7|||Mixed Models Analysis|||Baseline to Day 60||34.7|-28.7|0.902
72364241|NCT05565742|144240228|SUPERIORITY||LS Mean difference (Final Values)|-3.9|STANDARD_ERROR_OF_MEAN|13.65||0.779|TWO_SIDED|95.0|-27.4|27.1|||Mixed Models Analysis|||Baseline to Day 60||27.1|-27.4|0.779
72364242|NCT05565742|144240228|SUPERIORITY||LS Mean difference (Final Values)|-3.9|STANDARD_ERROR_OF_MEAN|13.65||0.779|TWO_SIDED|95.0|-27.4|27.1|||Mixed Models Analysis|||Baseline to Day 60||27.1|-27.4|0.779
72364243|NCT05565742|144240228|SUPERIORITY||LS Mean difference (Final Values)|0.3|STANDARD_ERROR_OF_MEAN|20.41||0.987|TWO_SIDED|95.0|-32.8|49.7|||Mixed Models Analysis|||Baseline to Day 180||49.7|-32.8|0.987
72364244|NCT05565742|144240228|SUPERIORITY||LS Mean difference (Final Values)|-15.2|STANDARD_ERROR_OF_MEAN|13.96||0.316|TWO_SIDED|95.0|-38.7|17.2|||Mixed Models Analysis|||Baseline to Day 180||17.2|-38.7|0.316
72364245|NCT05565742|144240228|SUPERIORITY||LS Mean difference (Final Values)|5.4|STANDARD_ERROR_OF_MEAN|15.37||0.72|TWO_SIDED|95.0|-20.9|40.4|||Mixed Models Analysis|||Baseline to Day 180||40.4|-20.9|0.720
72364246|NCT05565742|144240228|SUPERIORITY||LS Mean difference (Final Values)|5.4|STANDARD_ERROR_OF_MEAN|15.37||0.72|TWO_SIDED|95.0|-20.9|40.4|||Mixed Models Analysis|||Baseline to Day 180||40.4|-20.9|0.720
72364247|NCT05565742|144240228|SUPERIORITY||LS Mean difference (Final Values)|-11.5|STANDARD_ERROR_OF_MEAN|14.66||0.461|TWO_SIDED|95.0|-36.1|22.6|||Mixed Models Analysis|||Baseline to Day 240||22.6|-36.1|0.461
72364248|NCT05565742|144240228|SUPERIORITY||LS Mean difference (Final Values)|-16.1|STANDARD_ERROR_OF_MEAN|11.29||0.194|TWO_SIDED|95.0|-35.6|9.4|||Mixed Models Analysis|||Baseline to Day 240||9.4|-35.6|0.194
72364249|NCT05565742|144240228|SUPERIORITY||LS Mean difference (Final Values)|-1.7|STANDARD_ERROR_OF_MEAN|12.87||0.898|TWO_SIDED|95.0|-24.0|27.2|||Mixed Models Analysis|||Baseline to Day 240||27.2|-24.0|0.898
72364250|NCT05565742|144240228|SUPERIORITY||LS Mean difference (Final Values)|-9.4|STANDARD_ERROR_OF_MEAN|11.81||0.448|TWO_SIDED|95.0|-29.9|17.0|||Mixed Models Analysis|||Baseline to Day 240||17.0|-29.9|0.448
72364251|NCT05565742|144240228|SUPERIORITY||LS Mean difference (Final Values)|29.6|STANDARD_ERROR_OF_MEAN|28.05||0.233|TWO_SIDED|95.0|-15.4|98.4|||Mixed Models Analysis|||Baseline to Day 360||98.4|-15.4|0.233
72364252|NCT05565742|144240228|SUPERIORITY||LS Mean difference (Final Values)|2.4|STANDARD_ERROR_OF_MEAN|18.04||0.891|TWO_SIDED|95.0|-27.6|44.9|||Mixed Models Analysis|||Baseline to Day 360||44.9|-27.6|0.891
72364253|NCT05565742|144240228|SUPERIORITY||LS Mean difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|17.18||0.984|TWO_SIDED|95.0|-29.0|39.9|||Mixed Models Analysis|||Baseline to Day 360||39.9|-29.0|0.984
72364254|NCT05565742|144240228|SUPERIORITY||LS Mean difference (Final Values)|19.4|STANDARD_ERROR_OF_MEAN|20.52||0.302|TWO_SIDED|95.0|-14.8|67.5|||Mixed Models Analysis|||Baseline to Day 360||67.5|-14.8|0.302
72364255|NCT05565742|144240228|SUPERIORITY||LS Mean difference (Final Values)|-7.9|STANDARD_ERROR_OF_MEAN|18.49||0.684|TWO_SIDED|95.0|-37.9|36.8|||Mixed Models Analysis|||Baseline to Day 540||36.8|-37.9|0.684
72364256|NCT05565742|144240228|SUPERIORITY||LS Mean difference (Final Values)|-1.4|STANDARD_ERROR_OF_MEAN|16.19||0.933|TWO_SIDED|95.0|-28.6|36.3|||Mixed Models Analysis|||Baseline to Day 540||36.3|-28.6|0.933
72364257|NCT05565742|144240228|SUPERIORITY||LS Mean difference (Final Values)|0.8|STANDARD_ERROR_OF_MEAN|16.33||0.962|TWO_SIDED|95.0|-26.7|38.6|||Mixed Models Analysis|||Baseline to Day 540||38.6|-26.7|0.962
72364258|NCT05565742|144240228|SUPERIORITY||LS Mean difference (Final Values)|13.9|STANDARD_ERROR_OF_MEAN|18.52||0.422|TWO_SIDED|95.0|-17.2|56.9|||Mixed Models Analysis|||Baseline to Day 540||56.9|-17.2|0.422
72364259|NCT02855125|144240230|SUPERIORITY||Hazard Ratio (HR)|1.16||||0.2744|TWO_SIDED|95.0|0.71|1.88|||Log Rank|1-sided stratified log-rank test.|Based on stratified Cox regression model .|||1.88|0.71|0.2744
72364260|NCT02855125|144240231|SUPERIORITY||Hazard Ratio (HR)|1.31||||0.1431|TWO_SIDED|95.0|0.8|2.14|||Log Rank|1-sided stratified log-rank test.|Based on stratified Cox regression model.|||2.14|0.80|0.1431
72364261|NCT04467905|144240236|SUPERIORITY||Mean Difference (Final Values)|-29.9|||<|0.0001|TWO_SIDED|95.0|-40.3|-19.3|||ANCOVA||The mean difference is the difference in adjusted means for the change between baseline value and nadir in the placebo group and the change between baseline and nadir in the etripamil group.|||-19.3|-40.3|<0.0001
72364262|NCT04586205|144240247|OTHER|||||||0.024|||||||ANOVA|||The baseline measurement for this analysis is the Sternberg Sorting Task (SST) at Baseline. This task is designed to assess how individuals store and retrieve random information from short-term memory. This task was administered to all participants before they were randomized into one of two groups (active TMS first then sham TMS or sham TMS first then active TMS).||||0.024
72431592|NCT01290094|144375105|SUPERIORITY_OR_OTHER|||||||0.027|TWO_SIDED|||||Month 24: P-value for percent change from baseline was from a paired samples t-test.|Paired t-test|||||||0.027
72364263|NCT04586205|144240248|OTHER||Mean Difference (Final Values)|0.02||||0.18|TWO_SIDED||||||t-test, 2 sided||The difference in means between High-Load IAPS (.69) and Low-Load IAPS (.67) in the group that received active then sham TMS.|The baseline measurement for this analysis is the International Affective Picture System (IAPS) at baseline. This is an emotional task using IAPS picture that will also compare low load and high load conditions. The number of images will vary by condition load, but for both the high-load \& low-load conditions, participants will look at IAPS pictures and answer questions about the images. We compare mean High-Load IAPS and Low-Load IAPS scores in the group that received active then sham TMS.||||0.18
72364264|NCT04586205|144240249|OTHER|||||||0.19|||||||Chi-squared|||The outcome measure for this analysis was the International Affective Picture System (IAPS).||||0.19
72364265|NCT04586205|144240250|SUPERIORITY|||||||0.67|||||||t-test, 2 sided|||||||0.67
72364266|NCT02121535|144240301|NON_INFERIORITY_OR_EQUIVALENCE|To determine whether the 2-sided 90% confidence interval (CI) for the intra-subject ratio of the AUC0-tz were contained in the acceptance range of 80% to 125% for bioequivalence.|Adjusted Mean Ratio|101.97|||||TWO_SIDED|90.0|98.94|105.08|||||Adjusted Mean Ratio (Test/Reference)|The statistical model used for the analysis of AUC0-tz was a mixed effect model on the logarithmic scale.||105.08|98.94|
72364267|NCT02121535|144240302|NON_INFERIORITY_OR_EQUIVALENCE|To determine whether the 2-sided 90% CI for the intra-subject ratio of the Cmax were contained in the acceptance range of 80% to 125% for bioequivalence.|Adjusted Mean Ratio|103.77|||||TWO_SIDED|90.0|97.03|110.99|||||Adjusted Mean Ratio (Test/Reference)|The statistical model used for the analysis of Cmax was a mixed effect model on the logarithmic scale.||110.99|97.03|
72364268|NCT02121535|144240303|NON_INFERIORITY_OR_EQUIVALENCE|To determine whether the 2-sided 90% CI for the intra-subject ratio of the AUC0-∞ were contained in the acceptance range of 80% to 125% for bioequivalence.|Adjusted Mean Ratio|100.24|||||TWO_SIDED|90.0|96.8|103.8|||||Adjusted Mean Ratio (Test/Reference)|The statistical model used for the analysis of AUC0--∞ was a mixed effect model on the logarithmic scale.||103.80|96.80|
72364269|NCT02121535|144240304|NON_INFERIORITY_OR_EQUIVALENCE|To determine whether the 2-sided 90% CI for the intra-subject ratio of the AUC0-∞ were contained in the acceptance range of 80% to 125% for bioequivalence.|Adjusted Mean Ratio|99.42|||||TWO_SIDED|90.0|97.94|100.93|||||Adjusted Mean Ratio (Test/Reference)|The statistical model used for the analysis of AUC0--∞ was a mixed effect model on the logarithmic scale.||100.93|97.94|
72364270|NCT02121535|144240305|NON_INFERIORITY_OR_EQUIVALENCE|To determine whether the 2-sided 90% CI for the intra-subject ratio of the AUC0-tz were contained in the acceptance range of 80% to 125% for bioequivalence.|Adjusted Mean Ratio|99.5|||||TWO_SIDED|90.0|98.08|100.94|||||Adjusted Mean Ratio (Test/Reference)|The statistical model used for the analysis of AUC0-tz was a mixed effect model on the logarithmic scale.||100.94|98.08|
72364271|NCT02121535|144240306|NON_INFERIORITY_OR_EQUIVALENCE|To determine whether the 2-sided 90% CI for the intra-subject ratio of the Cmax were contained in the acceptance range of 80% to 125% for bioequivalence.|Adjusted Mean Ratio|100.07|||||TWO_SIDED|90.0|98.45|101.72|||||Adjusted Mean Ratio (Test/Reference)|The statistical model used for the analysis of Cmax was a mixed effect model on the logarithmic scale.||101.72|98.45|
72364272|NCT02121535|144240307|NON_INFERIORITY_OR_EQUIVALENCE|To determine whether the 2-sided 90% CI for the intra-subject ratio of the Cmax were contained in the acceptance range of 80% to 125% for bioequivalence.|Adjusted Mean Ratio|110.16|||||TWO_SIDED|90.0|106.87|113.54|||||Adjusted Mean Ratio (Test/Reference)|The statistical model used for the analysis of Cmax was a mixed effect model on the logarithmic scale.||113.54|106.87|
72364273|NCT02121535|144240308|NON_INFERIORITY_OR_EQUIVALENCE|To determine whether the 2-sided 90% CI for the intra-subject ratio of the AUC0-tz were contained in the acceptance range of 80% to 125% for bioequivalence.|Adjusted Mean Ratio|104.3|||||TWO_SIDED|90.0|102.53|106.1|||||Adjusted Mean Ratio (Test/Reference)|The statistical model used for the analysis of AUC0-tz was a mixed effect model on the logarithmic scale.||106.10|102.53|
72364274|NCT02121535|144240309|NON_INFERIORITY_OR_EQUIVALENCE|To determine whether the 2-sided 90% CI for the intra-subject ratio of the AUC0-∞ were contained in the acceptance range of 80% to 125% for bioequivalence.|Adjusted Mean Ratio|104.37|||||TWO_SIDED|90.0|102.68|106.1|||||Adjusted Mean Ratio (Test/Reference)|The statistical model used for the analysis of AUC0--∞ was a mixed effect model on the logarithmic scale.||106.10|102.68|
72364275|NCT00091949|144240310|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.76||||0.0067|TWO_SIDED|95.0|0.62|0.93||P-value adjusted for interim looks.|Regression, Cox||Pioglitazone arm compared to placebo; CI adjusted for interim looks.|||0.93|0.62|.0067
72364276|NCT00091949|144240311|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.82||||0.19|TWO_SIDED|95.0|0.61|1.1||P-value adjusted for multiplicity (5 secondary outcomes).|Regression, Cox||Pioglitazone arm compared to placebo; conference interval (CI) adjusted for multiplicity (5 secondary outcomes).|||1.1|0.61|0.19
72364277|NCT00091949|144240312|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.75||||0.11|TWO_SIDED|95.0|0.52|1.07||P-value adjusted for multiplicity (5 secondary outcomes).|Regression, Cox||Pioglitazone arm compared to placebo; CI adjusted for multiplicity (5 secondary outcomes).|||1.07|0.52|0.11
72364278|NCT00091949|144240314|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.93||||0.52|TWO_SIDED|95.0|0.73|1.17||p-value adjusted for multiplicity (5 secondary outcomes)|Regression, Cox||Pioglitazone arm compared to placebo; CI adjusted for multiplicity (5 secondary outcomes).|||1.17|0.73|0.52
72364279|NCT00091949|144240315|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.023||||0.88|TWO_SIDED|95.0|-0.326|0.28|||Mixed Models Analysis||Pioglitazone arm compared to placebo.|Changes in modified mini-mental examination (3MS) score from baseline (to annual scores) were analyzed using a longitudinal repeated measures mixed effects model.||0.280|-0.326|0.88
72364280|NCT00091949|144240316|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.82||||0.11|TWO_SIDED|95.0|0.65|1.05||P-value adjusted for multiplicity (5 secondary outcomes).|Regression, Cox||Pioglitazone arm compared to placebo; CI adjusted for multiplicity (5 secondary outcomes).|||1.05|0.65|0.11
72364281|NCT01347112|144240388|SUPERIORITY_OR_OTHER|||||||0.034||||||1 tailed fisher's exact test|Fisher Exact|1 tailed||||||0.034
72364282|NCT01347112|144240389|SUPERIORITY_OR_OTHER|||||||0.044||||||1 tailed fisher's exact|Fisher Exact|1 tailed||||||0.044
72364283|NCT01347112|144240390|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.3|||||TWO_SIDED|90.0|-4.7|2.1|||||data were analyzed using analysis of covariance with treatment as the independent variable and the baseline value included as the co-variate|||2.1|-4.7|
72364284|NCT00313014|144240422|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.67|STANDARD_ERROR_OF_MEAN|0.163|<|0.001|TWO_SIDED|95.0|-0.99|-0.35||P value was 2-sided and performed at the 5% error level.|Mixed Models Analysis|Repeated measures mixed linear model with treatment, time, and time by treatment interaction as fixed effects.||The null hypothesis was that there was no difference between BTDS 20 or oxycodone HCl immediate-release 40 mg with respect to BTDS 5. The alternative hypothesis was that the BTDS 20 arm was different from the BTDS 5 arm.||-0.35|-0.99|<.001
72364285|NCT00313014|144240422|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.75|STANDARD_ERROR_OF_MEAN|0.161|<|0.001|TWO_SIDED|95.0|-1.07|-0.44||P value was 2-sided and performed at the 5% error level.|Mixed Models Analysis|Repeated measures mixed linear model with treatment, time, and time by treatment interaction as fixed effect.||The null hypothesis was that there was no difference between BTDS 20 or oxycodone HCl immediate-release 40 mg with respect to BTDS 5. The alternative hypothesis was that the BTDS 20 arm was different from the BTDS 5 arm.||-0.44|-1.07|<.001
72364286|NCT00313014|144240423|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5||||0.006|TWO_SIDED|95.0|-0.9|-0.13||To address the issue of multiplicity and control the family-wise error rate, a gate-keeping strategy and a stepwise approach (Holm's methodology) were used to evaluate the statistical significance of the secondary efficacy analyses.|ANCOVA||The analysis was based on the number of subjects who took \> 1 tablet of supplemental analgesia.|The null hypothesis was that there was no difference between BTDS 20 or oxycodone HCl immediate-release 40 mg with respect to BTDS 5. The alternative hypothesis was that the BTDS 20 arm was different from the BTDS 5 arm.||-0.13|-0.90|.006
72364287|NCT00313014|144240423|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3||||0.158|TWO_SIDED|95.0|-0.7|0.09||To address the issue of multiplicity and control the family-wise error rate, a gate-keeping strategy and a stepwise approach (Holm's methodology) were used to evaluate the statistical significance of the secondary efficacy analyses.|ANCOVA||The analysis was based on the number of subjects who took \> 1 tablet of supplemental analgesia.|The null hypothesis was that there was no difference between BTDS 20 or oxycodone HCl immediate-release 40 mg with respect to BTDS 5. The alternative hypothesis was that the BTDS 20 arm was different from the BTDS 5 arm.||0.09|-0.70|.158
72364288|NCT00313014|144240424|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.72||||0.065|TWO_SIDED|95.0|-3.55|0.11||To address the issue of multiplicity and control the family-wise error rate, a gate-keeping strategy and a stepwise approach (Holm's methodology) were used to evaluate the statistical significance of the secondary efficacy analyses.|Mixed Models Analysis|||The null hypothesis was that there was no difference between BTDS 20 or oxycodone HCl immediate-release 40 mg with respect to BTDS 5. The alternative hypothesis was that the BTDS 20 arm was different from the BTDS 5 arm.||0.11|-3.55|.065
72364289|NCT00313014|144240424|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.99||||0.031||95.0|-3.79|-0.18||To address the issue of multiplicity and control the family-wise error rate, a gate-keeping strategy and a stepwise approach (Holm's methodology) were used to evaluate the statistical significance of the secondary efficacy analyses.|Mixed Models Analysis|||The null hypothesis was that there was no difference between BTDS 20 or oxycodone HCl immediate-release 40 mg with respect to BTDS 5. The alternative hypothesis was that the BTDS 20 arm was different from the BTDS 5 arm.||-0.18|-3.79|.031
72364290|NCT00313014|144240425|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.23|STANDARD_ERROR_OF_MEAN|1.735|<|0.001|TWO_SIDED|95.0|-9.64|-2.82||To address the issue of multiplicity and control the family-wise error rate, a gate-keeping strategy and a stepwise approach (Holm's methodology) were used to evaluate the statistical significance of the secondary efficacy analyses.|Mixed Models Analysis|Mixed linear model: treatment, time as fixed effects, screening, prerandomization sleep disturbance subscale as covariates; subject as a random effect||The null hypothesis was that there was no difference between BTDS 20 or oxycodone HCl immediate-release 40 mg with respect to BTDS 5. The alternative hypothesis was that the BTDS 20 arm was different from the BTDS 5 arm.||-2.82|-9.64|<.001
72364291|NCT00313014|144240425|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.65|STANDARD_ERROR_OF_MEAN|1.709||0.121||95.0|-6.01|0.7||To address the issue of multiplicity and control the family-wise error rate, a gate-keeping strategy and a stepwise approach (Holm's methodology) were used to evaluate the statistical significance of the secondary efficacy analyses.|Mixed Models Analysis|||The null hypothesis was that there was no difference between BTDS 20 or oxycodone HCl immediate-release 40 mg with respect to BTDS 5. The alternative hypothesis was that BTDS 20 arm was different from the BTDS 5 arm.||0.70|-6.01|.121
72364292|NCT01181349|144240435|SUPERIORITY_OR_OTHER||||||=|0.169|||||||Chi-square test or Fisher's Exact Test|||Cross tables were performed between TOF ratio and medications administered. Statistical significance was evaluated using Chi-square test or Fisher's Exact Test. All tests were performed at a significance level of 0.05.||||=0.169
72364293|NCT01181349|144240437|SUPERIORITY_OR_OTHER||||||=|0.01|||||||Chi-square test or Fisher's Exact Test|||Cross tables were performed between TOF ratio and medications administered. Statistical significance was evaluated using Chi-square test or Fisher's Exact Test. All tests were performed at a significance level of 0.05.||||=0.01
72364294|NCT01337960|144240450|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||Fisher Exact|||||||< 0.01
72364295|NCT01337960|144240451|SUPERIORITY_OR_OTHER||||||<|0.02|TWO_SIDED||||||Fisher Exact|||||||<.02
72364296|NCT01337960|144240452|SUPERIORITY_OR_OTHER||||||=|0.17|TWO_SIDED||||||Fisher Exact|||||||=0.17
72364297|NCT01337960|144240453|SUPERIORITY_OR_OTHER||||||=|0.35|TWO_SIDED||||||Fisher Exact|||||||=0.35
72368804|NCT02637037|144247319|NON_INFERIORITY_OR_EQUIVALENCE|If the 90% CIs for both dapagliflozin and metformin geometric mean ratio of AUC is entirely contained within an 80.00% to 125.00% interval, it will be concluded the 2 manufacturing sites are bioequivalent.|Ratios of Geometric means|1.03|||||TWO_SIDED|90.0|0.96|1.1||||||Metformin: Statistical Assessment of Bioequivalence for Metformin following administration Dapagliflozin/Metformin XR 10/1000 mg for Treatment G and H.||1.10|0.96|
72364298|NCT04090203|144240547|SUPERIORITY||Percentage|75.0||||0.001|ONE_SIDED|95.0|40.0|||The test was performed at a one-sided significance level of 0.05.|Exact binomial test|The null hypothesis of the exact binomial test was that the percentage of patients who were successfully desensitized was less than or equal to 20%.|The percentage of successfully desensitized participants is presented with a one-sided 95% CI, obtained from the lower bound of the two-sided 90% Clopper-Pearson exact confidence interval.|The null hypothesis was that the percentage of patients who were successfully desensitized was less than or equal to 20%, and the alternative hypothesis was that this percentage was greater than 20%. Assuming 80% of study participants would be successfully desensitized, a sample size of 10 patients would provide greater than 90% power to reject the null hypothesis using a one-sided exact binomial test with a significance level of 0.05.|||40.0|0.001
72364299|NCT04225897|144240580|OTHER||Difference|-8.02|||||TWO_SIDED|95.0|-31.78|15.74||||||60 hours. Analysis was performed using mixed effects analysis of covariance model on change from baseline in viral load, including a random effect for participant and fixed effects for treatment group, baseline human rhinovirus/enterovirus status (present or absent), visit, vist by treatment group interaction, and baseline viral load as a covariate.||15.74|-31.78|
72364300|NCT04225897|144240580|OTHER||Difference|-15.22|||||TWO_SIDED|95.0|-40.15|9.7|||Mixed effects analysis of covariance|||156 hours. Analysis was performed using mixed effects analysis of covariance model on change from baseline in viral load, including a random effect for participant and fixed effects for treatment group, baseline human rhinovirus/enterovirus status (present or absent), visit, vist by treatment group interaction, and baseline viral load as a covariate.||9.70|-40.15|
72364301|NCT04225897|144240581|OTHER||Difference|14.82|||||TWO_SIDED|95.0|-91.68|121.33||||||60 hours. Analysis was performed using mixed effects analysis of covariance model on change from baseline in viral load, including a random effect for participant and fixed effects for treatment group, baseline human rhinovirus/enterovirus status (present or absent), visit, vist by treatment group interaction, and baseline viral load as a covariate.||121.33|-91.68|
72364302|NCT04225897|144240581|OTHER||Difference|-31.19|||||TWO_SIDED|95.0|-143.96|81.57||||||156 hours. Analysis was performed using mixed effects analysis of covariance model on change from baseline in viral load, including a random effect for participant and fixed effects for treatment group, baseline human rhinovirus/enterovirus status (present or absent), visit, vist by treatment group interaction, and baseline viral load as a covariate.||81.57|-143.96|
72364303|NCT01285323|144240626|SUPERIORITY_OR_OTHER_LEGACY||CAE rate ratio (reslizumab vs placebo)|0.4063|||<|0.0001|TWO_SIDED|95.0|0.2819|0.5855||The treatment effect was tested using the likelihood based Chi-square test at the 0.05 significance level.|Chi-squared|||The frequency of CAEs was analyzed using the generalized linear model (GLM) for data from the negative binomial distributions that is commonly referred to as the negative binomial (NB) regression model. The primary NB model included the treatment group and randomization stratification factors as model factors and the logarithm of follow up time excluding the summed duration of exacerbations in the treatment period as an offset variable.||0.5855|0.2819|<0.0001
72364304|NCT01285323|144240627|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.101|STANDARD_ERROR_OF_MEAN|0.0397||0.0109|TWO_SIDED|95.0|0.023|0.179||Statistical significance at \<=0.05.|Mixed model repeated measures (MMRM)|Fixed Factors: treatment, visit, trt by visit interaction, region, OCS at enrollment, sex. Random: covariates for height, baseline value and patient|active - placebo|A pre-specified fixed sequence multiple testing procedure was implemented to test the secondary endpoints while controlling the overall Type I error rate at 0.05. At the point where p\>0.05, no further comparisons were interpreted inferentially.||0.179|0.023|0.0109
72364305|NCT01285323|144240628|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.093|STANDARD_ERROR_OF_MEAN|0.0317||0.0037|TWO_SIDED|95.0|0.03|0.155||Statistical significance at \<=0.05.|Mixed model repeated measures (MMRM)|Fixed Factors: treatment, visit, trt by visit interaction, region, OCS at enrollment, sex. Random: covariates for height, baseline value and patient|active-placebo|A pre-specified fixed sequence multiple testing procedure was implemented to test the secondary endpoints while controlling the overall Type I error rate at 0.05. At the point where p\>0.05, no further comparisons were interpreted inferentially.||0.155|0.030|0.0037
72364306|NCT01285323|144240629|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.209|STANDARD_ERROR_OF_MEAN|0.937||0.0259|TWO_SIDED|95.0|0.025|0.393||Statistical significance at \<=0.05.|Mixed model repeated measures (MMRM)|Fixed Factors: treatment, visit, trt by visit interaction, region, OCS at enrollment, sex. Random: covariates for height, baseline value and patient|active - placebo|A pre-specified fixed sequence multiple testing procedure was implemented to test the secondary endpoints while controlling the overall Type I error rate at 0.05. At the point where p\>0.05, no further comparisons were interpreted inferentially.||0.393|0.025|0.0259
72364307|NCT01285323|144240630|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.196|STANDARD_ERROR_OF_MEAN|0.0664||0.0032|TWO_SIDED|95.0|-0.327|-0.066||Statistical significance at \<=0.05.|Mixed model repeated measures (MMRM)|Fixed Factors: treatment, visit, trt by visit interaction, region, OCS at enrollment, sex. Random: covariates for height, baseline value and patient|active - placebo|A pre-specified fixed sequence multiple testing procedure was implemented to test the secondary endpoints while controlling the overall Type I error rate at 0.05. At the point where p\>0.05, no further comparisons were interpreted inferentially.||-0.066|-0.327|0.0032
72364308|NCT01285323|144240631|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.486|||<|0.0001|TWO_SIDED|95.0|0.353|0.67|||Regression, Cox|Stratified by baseline usage of oral corticosteroid (yes or no) and geographical region (US or other).|Reslizumab vs placebo|Kaplan-Meier estimate of probability (5) of not experiencing a CAE by week 52. The first CAEs for each patient occurring after randomization and up to 2 weeks after the end of treatment period were analyzed. Patients without a CAE within this time frame were censored at two weeks after the treatment completion date or study discontinuation, whichever came first.||0.670|0.353|<0.0001
72364309|NCT01285323|144240632|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.035|STANDARD_ERROR_OF_MEAN|0.012||0.0037|TWO_SIDED|95.0|0.011|0.059||Statistical significance at \<=0.05.|Mixed model repeated measures (MMRM)|Fixed Factors: treatment, visit, trt by visit interaction, region, OCS at enrollment, sex. Random: covariates for height, baseline value and patient|active - placebo|A pre-specified fixed sequence multiple testing procedure was implemented to test the secondary endpoints while controlling the overall Type I error rate at 0.05. At the point where p\>0.05, no further comparisons were interpreted inferentially.||0.059|0.011|0.0037
72364310|NCT01285323|144240633|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.062|STANDARD_ERROR_OF_MEAN|0.1775||0.7263|TWO_SIDED|95.0|-0.411|0.287||Statistical significance at \<=0.05.|Mixed model repeated measures (MMRM)|Fixed Factors: treatment, visit, trt by visit interaction, region, OCS at enrollment, sex. Random: covariates for height, baseline value and patient|active - placebo|A pre-specified fixed sequence multiple testing procedure was implemented to test the secondary endpoints while controlling the overall Type I error rate at 0.05. At the point where p\>0.05, no further comparisons were interpreted inferentially.||0.287|-0.411|0.7263
72364311|NCT01285323|144240636|SUPERIORITY_OR_OTHER_LEGACY||CAE rate ratio (reslizumab vs placebo)|0.3893|||<|0.0001|TWO_SIDED|95.0|0.2621|0.5782||The treatment effect was tested using the likelihood based Chi-square test at the 0.05 significance level.|Chi-squared|||CAE Due to Requiring Systemic Corticosteroids The frequency of CAEs was analyzed using the generalized linear model (GLM) for data from the negative binomial distributions that is commonly referred to as the negative binomial (NB) regression model. The primary NB model included the treatment group and randomization stratification factors as model factors and the logarithm of follow up time excluding the summed duration of exacerbations in the treatment period as an offset variable.||0.5782|0.2621|<0.0001
72364312|NCT01285323|144240636|SUPERIORITY_OR_OTHER_LEGACY||CAE rate ratio|0.6686||||0.402|TWO_SIDED|95.0|0.2878|1.6479||The treatment effect was tested using the likelihood based Chi-square test at the 0.05 significance level.|Chi-squared|||CAE Due to Hospitalization or ER visit The frequency of CAEs was analyzed using the generalized linear model (GLM) for data from the negative binomial distributions that is commonly referred to as the negative binomial (NB) regression model. The primary NB model included the treatment group and randomization stratification factors as model factors and the logarithm of follow up time excluding the summed duration of exacerbations in the treatment period as an offset variable.||1.6479|0.2878|0.4020
72364313|NCT02668653|144240648|OTHER||Hazard Ratio (HR)|0.776||||0.0324|TWO_SIDED|95.0|0.615|0.979|||Log Rank|Stratification factors include region, age, and WBC count at the time of diagnosis of AML.||||0.979|0.615|0.0324
72364314|NCT00979940|144240658|SUPERIORITY_OR_OTHER|||||||0.97|TWO_SIDED||||||Chi-squared|||||||0.97
72364315|NCT01294553|144240660|SUPERIORITY_OR_OTHER||Percentage of participants|15.4|||||TWO_SIDED|95.0|12.8|18.1|||||The estimated value represents the percentage of participants with an adverse event.|||18.1|12.8|
72364316|NCT00926237|144240663|SUPERIORITY||Mean Difference (Final Values)|-5.74||||0.04|ONE_SIDED|||||t value = -1.40|Mixed Models Analysis||1Hz active rTMS - Sham rTMS|||||.04
72364317|NCT00926237|144240663|SUPERIORITY||Mean Difference (Final Values)|-6.77||||0.02|ONE_SIDED|||||t value = -2.03|Mixed Models Analysis||10 Hz active rTMS - Sham rTMS|||||.02
72364318|NCT00926237|144240663|SUPERIORITY||Mean Difference (Final Values)|-4.73||||0.2|ONE_SIDED|||||t value = -1..28|Mixed Models Analysis||10 Hz washout - sham washout period|||||.20
72364319|NCT00926237|144240663|SUPERIORITY||Mean Difference (Final Values)|-5.19||||0.19|ONE_SIDED|||||t value = -1.29|Mixed Models Analysis||1Hz washout - sham washout|||||.19
72364320|NCT00632229|144240670|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||ANCOVA|||To evaluate between-group continuous outcomes of the pilot controlled trial, ANCOVAs were performed, where 8-week outcome scores were predicted by treatment condition while covarying for baseline scores.||||<0.05
72364321|NCT00632229|144240671|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||ANCOVA|||To evaluate between-group continuous outcomes of the pilot controlled trial, ANCOVAs were performed, where 8-week outcome scores were predicted by treatment condition while covarying for baseline scores.||||<0.05
72364322|NCT02667119|144240682|SUPERIORITY||F|4.75||||0.041|TWO_SIDED||||||ANCOVA|Controlled for baseline scores on the National Stressful Events PTSD Scale||Compared the two groups at 3 months post-baseline||||.041
72364323|NCT02667119|144240683|SUPERIORITY||F|6.89||||0.016|TWO_SIDED||||||ANCOVA|Controlled for baseline score on the National Stressful Events PTSD Scale||||||.016
72364324|NCT02667119|144240684|SUPERIORITY||t|-2.19||||0.04|TWO_SIDED||||||t-test, 2 sided|||||||.04
72364325|NCT02667119|144240685|SUPERIORITY||F|2.25||||0.148|TWO_SIDED|||||Controlling for baseline score on the Center for Epidemiological Studies-Depressed Mood scale|ANCOVA|||||||.148
72364326|NCT02667119|144240686|SUPERIORITY||F|4.64||||0.043|TWO_SIDED||||||ANCOVA|Controlling for baseline score on the Center for Epidemiological Studies-Depressed Mood scale||||||.043
72364327|NCT02667119|144240687|SUPERIORITY||F|1.4||||0.25|TWO_SIDED|||||Controlling for baseline score on the Quality of Life Scale|ANCOVA|||||||.250
72364328|NCT02667119|144240688|SUPERIORITY||F|0.45||||0.508|TWO_SIDED||||||ANCOVA|Controlling for baseline score on the Quality of Life Scale||||||.508
72364329|NCT02059278|144240701|EQUIVALENCE|Analysis at 8 am on Day 15|Mean Difference (Final Values)|0.781||||0.0091|TWO_SIDED|95.0|0.195|1.366|||ANCOVA||ANCOVA on change from baseline at 8 am on Day 15|The primary endpoint was measured at 9 separate assessment times (3 time points over a 12 hour period on 3 separate days. The primary analysis was based on a comparison of the IOP change from baseline between the two arms at each assessment.The equivalence margin was tested using an analysis of covariance on change from baseline with pooled site and baseline as a factor. Equivalence was considered to be met if the 95% confidence intervals were within 1.5 mmHg at each of the 9 assessment points.||1.366|0.195|0.0091
72364330|NCT02059278|144240701|EQUIVALENCE|Analysis at 10 am on Day 15|Mean Difference (Final Values)|0.664||||0.0098|TWO_SIDED|95.0|0.161|1.167|||ANCOVA||ANCOVA on change from baseline at 10 am on Day 15|The primary endpoint was measured at 9 separate assessment times (3 time points over a 12 hour period on 3 separate days. The primary analysis was based on a comparison of the IOP change from baseline between the two arms at each assessment.The equivalence margin was tested using an analysis of covariance on change from baseline with pooled site and baseline as a factor. Equivalence was considered to be met if the 95% confidence intervals were within 1.5 mmHg at each of the 9 assessment points.||1.167|0.161|0.0098
72368805|NCT02637037|144247320|NON_INFERIORITY_OR_EQUIVALENCE|If the 90% CIs for both dapagliflozin and metformin geometric mean ratio of AUC is entirely contained within an 80.00% to 125.00% interval, it will be concluded the 2 manufacturing sites are bioequivalent.|Ratios of Geometric means|0.96|||||TWO_SIDED|90.0|0.94|0.99||||||Dapagliflozin: Statistical Assessment of Bioequivalence for Dapagliflozin following administration Dapagliflozin/Metformin XR 5/500 mg for Treatment A and B.||0.99|0.94|
72364331|NCT02059278|144240701|EQUIVALENCE|Analysis at 4 pm on Day 15|Mean Difference (Final Values)|0.542||||0.0398|TWO_SIDED|95.0|0.025|1.058|||ANCOVA||ANCOVA on change from baseline at 4 pm on Day 15|The primary endpoint was measured at 9 separate assessment times (3 time points over a 12 hour period on 3 separate days. The primary analysis was based on a comparison of the IOP change from baseline between the two arms at each assessment.The equivalence margin was tested using an analysis of covariance on change from baseline with pooled site and baseline as a factor. Equivalence was considered to be met if the 95% confidence intervals were within 1.5 mmHg at each of the 9 assessment points.||1.058|0.025|0.0398
72364332|NCT02059278|144240701|EQUIVALENCE|Analysis at 8 am on Day 42|Mean Difference (Final Values)|0.478||||0.1008|TWO_SIDED|95.0|-0.093|1.05|||ANCOVA||ANCOVA on change from baseline at 8 am on Day 42|The primary endpoint was measured at 9 separate assessment times (3 time points over a 12 hour period on 3 separate days. The primary analysis was based on a comparison of the IOP change from baseline between the two arms at each assessment.The equivalence margin was tested using an analysis of covariance on change from baseline with pooled site and baseline as a factor. Equivalence was considered to be met if the 95% confidence intervals were within 1.5 mmHg at each of the 9 assessment points.||1.050|-0.093|0.1008
72364333|NCT02059278|144240701|EQUIVALENCE|Analysis at 10 am on Day 42|Mean Difference (Final Values)|0.505||||0.0558|TWO_SIDED|95.0|-0.013|1.024|||ANCOVA||ANCOVA on change from baseline at 10 am on Day 42|The primary endpoint was measured at 9 separate assessment times (3 time points over a 12 hour period on 3 separate days. The primary analysis was based on a comparison of the IOP change from baseline between the two arms at each assessment.The equivalence margin was tested using an analysis of covariance on change from baseline with pooled site and baseline as a factor. Equivalence was considered to be met if the 95% confidence intervals were within 1.5 mmHg at each of the 9 assessment points.||1.024|-0.013|0.0558
72364334|NCT02059278|144240701|EQUIVALENCE|Analysis at 4 pm on Day 42|Mean Difference (Final Values)|0.538||||0.0491|TWO_SIDED|95.0|0.002|1.074|||ANCOVA||ANCOVA on change from baseline at 4 pm on Day 42|The primary endpoint was measured at 9 separate assessment times (3 time points over a 12 hour period on 3 separate days. The primary analysis was based on a comparison of the IOP change from baseline between the two arms at each assessment.The equivalence margin was tested using an analysis of covariance on change from baseline with pooled site and baseline as a factor. Equivalence was considered to be met if the 95% confidence intervals were within 1.5 mmHg at each of the 9 assessment points.||1.074|0.002|0.0491
72364335|NCT02059278|144240701|EQUIVALENCE|Analysis at 8 am on Day 84|Mean Difference (Final Values)|0.808||||0.0025|TWO_SIDED|95.0|0.286|1.329|||ANCOVA||ANCOVA on change from baseline at 8 am on Day 84|The primary endpoint was measured at 9 separate assessment times (3 time points over a 12 hour period on 3 separate days. The primary analysis was based on a comparison of the IOP change from baseline between the two arms at each assessment.The equivalence margin was tested using an analysis of covariance on change from baseline with pooled site and baseline as a factor. Equivalence was considered to be met if the 95% confidence intervals were within 1.5 mmHg at each of the 9 assessment points.||1.329|0.286|0.0025
72364336|NCT02059278|144240701|EQUIVALENCE|Analysis at 10 am on Day 84|Mean Difference (Final Values)|0.627||||0.0113|TWO_SIDED|95.0|0.143|1.111|||ANCOVA||ANCOVA on change from baseline at 10 am on Day 84|The primary endpoint was measured at 9 separate assessment times (3 time points over a 12 hour period on 3 separate days. The primary analysis was based on a comparison of the IOP change from baseline between the two arms at each assessment.The equivalence margin was tested using an analysis of covariance on change from baseline with pooled site and baseline as a factor. Equivalence was considered to be met if the 95% confidence intervals were within 1.5 mmHg at each of the 9 assessment points.||1.111|0.143|0.0113
72364337|NCT02059278|144240701|EQUIVALENCE|Analysis at 4 pm on Day 84|Mean Difference (Final Values)|0.456||||0.0649|TWO_SIDED|95.0|-0.063|0.975|||ANCOVA||ANCOVA on change from baseline at 4 pm on Day 84|The primary endpoint was measured at 9 separate assessment times (3 time points over a 12 hour period on 3 separate days. The primary analysis was based on a comparison of the IOP change from baseline between the two arms at each assessment.The equivalence margin was tested using an analysis of covariance on change from baseline with pooled site and baseline as a factor. Equivalence was considered to be met if the 95% confidence intervals were within 1.5 mmHg at each of the 9 assessment points.||0.975|-0.063|0.0649
72364338|NCT04363320|144240711|SUPERIORITY||Slope|0.538|STANDARD_DEVIATION|0.169||0.002|TWO_SIDED|||||a prior threshold 0.05|Mixed Models Analysis||Slope is per month|Change in new patient counts (Combined MOUD) for Intervention Phase (from baseline to 12 months)||||0.002
72364339|NCT04363320|144240711|SUPERIORITY||Slope|0.38|STANDARD_DEVIATION|0.113||0.0008|TWO_SIDED|||||a priori threshold: 0.05|Mixed Models Analysis||Slope is per month.|Change in new patient counts (Buprenorphine) for Intervention Phase (from baseline to 12 months)||||0.0008
72364340|NCT04363320|144240711|SUPERIORITY||Slope|0.207|STANDARD_DEVIATION|0.129||0.111|TWO_SIDED|||||a priori threshold: 0.05|Mixed Models Analysis||Slope is per month.|Change in new patient counts (Methadone) for Intervention Phase (from baseline to 12 months)||||0.111
72364341|NCT04363320|144240711|SUPERIORITY||Slope|0.017|STANDARD_DEVIATION|0.014||0.235|TWO_SIDED|||||a priori threshold: 0.05|Mixed Models Analysis||Slope is per month.|Change in new patient counts (Naltrexone) for Intervention Phase (from baseline to 12 months)||||0.235
72364342|NCT04363320|144240712|SUPERIORITY||Slope|0.153|STANDARD_DEVIATION|0.218||0.485|TWO_SIDED|||||a priori threshold: 0.05|Mixed Models Analysis||Slope is per month|Change in new patient counts (Combined MOUD) for Sustainability Phase (from 13 to 24 months)||||0.485
72364343|NCT04363320|144240712|SUPERIORITY||Slope|0.642|STANDARD_DEVIATION|0.19||0.0008|TWO_SIDED|||||a priori threshold: 0.05|Mixed Models Analysis||Slope is per month.|Change in new Justice Involved Person counts (Buprenorphine) for Sustainability Phase (from 13 to 24 months)||||0.0008
72364344|NCT04363320|144240712|SUPERIORITY||Slope|-0.377|STANDARD_DEVIATION|0.154||0.015|TWO_SIDED|||||a priori threshold: 0.05|Mixed Models Analysis||Slope is per month.|Change in new patient counts (Methadone) for Sustainability Phase (from 13 to 24 months)||||0.015
72364345|NCT04363320|144240712|SUPERIORITY||Slope|-0.02|STANDARD_DEVIATION|0.017||0.241|TWO_SIDED|||||a priori threshold: 0.05|Mixed Models Analysis||Slope is per month.|Change in new patient counts (Naltrexone) for Sustainability Phase (from 13 to 24 months)||||0.241
72364346|NCT04363320|144240713|SUPERIORITY||Slope|1.912|STANDARD_DEVIATION|0.438||2e-05|TWO_SIDED|||||a priori threshold: 0.05|Mixed Models Analysis||Slope is per month.|Change in census patient counts (Combined MOUD) for Intervention Phase (from baseline to 12 months)||||0.00002
72364347|NCT04363320|144240713|SUPERIORITY||Slope|0.855|STANDARD_DEVIATION|0.206||4e-05|TWO_SIDED|||||a priori threshold: 0.05|Mixed Models Analysis||Slope is per month.|Change in census patient counts (Buprenorphine) for Intervention Phase (from baseline to 12 months)||||0.00004
72364348|NCT04363320|144240713|SUPERIORITY||Slope|0.322|STANDARD_DEVIATION|0.206||0.118|TWO_SIDED|||||a priori threshold: 0.05|Mixed Models Analysis||Slope is per month.|Change in census patient counts (Methadone) for Intervention Phase (from baseline to 12 months)||||0.118
72431593|NCT04091672|144375121|NON_INFERIORITY|"The one-sided 97.5% confidence interval (97.5% CI) was calculated for the difference (Control-RECELL) in percentages of subjects with confirmed treatment area closure.~The calculation used the normal approximation taking correlation into account. In order for the null hypothesis to be rejected and the non-inferiority of RECELL to be established, the upper limit of the 97.5% CI had to be less than 10%."||||||0.005|||||||1-sided z-test of proportions|alpha=0.025||||||.005
72431594|NCT04091672|144375122|SUPERIORITY|A geometric mean ratio (GMR of ratios) 95% CI with a lower bound exceeding 1 would indicate superiority of RECELL over Control with respect to this endpoint.||||||0.001|||||||GMR of ratios|||||||0.001
72431595|NCT02401529|144375128|SUPERIORITY_OR_OTHER|||||||0.033|TWO_SIDED||||||Chi-squared|||||||0.033
72431596|NCT02401529|144375129|SUPERIORITY_OR_OTHER|||||||0.026|TWO_SIDED||||||Chi-squared|||||||0.026
72431597|NCT02401529|144375130|SUPERIORITY_OR_OTHER|||||||0.016|TWO_SIDED||||||Chi-squared|||||||0.016
72431598|NCT02401529|144375131|SUPERIORITY_OR_OTHER|||||||0.019|TWO_SIDED||||||Chi-squared|||||||0.019
72431599|NCT02401529|144375132|SUPERIORITY_OR_OTHER|||||||0.012|TWO_SIDED||||||Chi-squared|||||||0.012
72431600|NCT02401529|144375133|SUPERIORITY_OR_OTHER|||||||0.024|TWO_SIDED||||||Chi-squared|||||||0.024
72431601|NCT02401529|144375134|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED||||||Chi-squared|||||||0.02
72431602|NCT02401529|144375135|SUPERIORITY_OR_OTHER|||||||0.017|TWO_SIDED||||||Chi-squared|||||||0.017
72431603|NCT02401529|144375136|SUPERIORITY_OR_OTHER|||||||0.026|TWO_SIDED||||||Chi-squared|||||||0.026
72431604|NCT02401529|144375137|SUPERIORITY_OR_OTHER|||||||0.019|TWO_SIDED||||||Chi-squared|||||||0.019
72431605|NCT02054247|144375201|SUPERIORITY|||||||0.442|||||||ANOVA|||||||0.442
72431606|NCT02054247|144375202|SUPERIORITY|||||||0.083|||||||ANOVA|||||||0.083
72431607|NCT02054247|144375203|SUPERIORITY|||||||0.125|||||||ANOVA|||||||0.125
72431608|NCT02054247|144375204|SUPERIORITY|||||||0.146|||||||ANOVA|||||||0.146
72431609|NCT04730947|144375207|SUPERIORITY|||||||0.027|||||||t-test, 2 sided|||||||0.027
72431610|NCT04730947|144375208|SUPERIORITY|||||||0.029|||||||t-test, 2 sided|||||||0.029
72431611|NCT04730947|144375209|SUPERIORITY|||||||0.006|||||||t-test, 2 sided|||||||0.006
72431612|NCT04730947|144375210|SUPERIORITY|||||||0.12|||||||t-test, 2 sided|||||||0.12
72431613|NCT04730947|144375211|SUPERIORITY|||||||0.014|||||||t-test, 2 sided|||||||0.014
72431614|NCT04730947|144375212|SUPERIORITY|||||||0.011|||||||t-test, 2 sided|||||||0.011
72431615|NCT04730947|144375213|SUPERIORITY|||||||0.088|||||||t-test, 2 sided|||||||0.088
72431616|NCT04730947|144375214|SUPERIORITY|||||||0.024|||||||t-test, 2 sided|||||||0.024
72431617|NCT04730947|144375215|SUPERIORITY|||||||0.136|||||||t-test, 2 sided|||||||0.136
72431618|NCT02949271|144375232|OTHER|||||||0.17|||||||Wilcoxon (Mann-Whitney)|||||||0.17
72431619|NCT02949271|144375233|OTHER|||||||0.18|||||||Wilcoxon (Mann-Whitney)|||||||0.18
72431620|NCT02949271|144375235|OTHER|||||||0.27|||||||Wilcoxon (Mann-Whitney)|||||||0.27
72431621|NCT02949271|144375236|OTHER|||||||0.28|||||||Chi-squared|||||||0.28
72431622|NCT02949271|144375237|OTHER|||||||0.85|||||||Chi-squared|||||||0.85
72431623|NCT02949271|144375238|OTHER|||||||0.53|||||||Wilcoxon (Mann-Whitney)|||||||0.53
72431624|NCT02949271|144375239|OTHER|||||||0.03|||||||Wilcoxon (Mann-Whitney)|||||||0.03
72431625|NCT02949271|144375240|OTHER|||||||0.21|||||||Chi-squared|||||||0.21
72431626|NCT02949271|144375242|OTHER|||||||0.08|||||||Chi-squared|||||||0.08
72431627|NCT05458102|144375254|OTHER||Geometric Least-squares Mean Ratio|560.0|||||TWO_SIDED|90.0|414.0|757.0|||||Parametric (normal theory) mixed-effects ANOVA model was fitted to the natural log-transformed values of the PK parameter under evaluation.|||757|414|
72431628|NCT05458102|144375254|OTHER||Geometric Least-squares Mean Ratio|137.0|||||TWO_SIDED|90.0|99.5|189.0|||||Parametric (normal theory) mixed-effects ANOVA model was fitted to the natural log-transformed values of the PK parameter under evaluation.|||189|99.5|
72431629|NCT05458102|144375255|OTHER||Geometric Least-squares Mean Ratio|433.0|||||TWO_SIDED|90.0|347.0|540.0|||||Parametric (normal theory) mixed-effects ANOVA model was fitted to the natural log-transformed values of the PK parameter under evaluation.|||540|347|
72431630|NCT05458102|144375255|OTHER||Geometric Least-squares Mean Ratio|118.0|||||TWO_SIDED|90.0|93.5|150.0|||||Parametric (normal theory) mixed-effects ANOVA model was fitted to the natural log-transformed values of the PK parameter under evaluation.|||150|93.5|
72431631|NCT05458102|144375256|OTHER||Geometric Least-squares Mean Ratio|752.0|||||TWO_SIDED|90.0|525.0|1080.0|||||Parametric (normal theory) mixed-effects ANOVA model was fitted to the natural log-transformed values of the PK parameter under evaluation.|||1080|525|
72431632|NCT05458102|144375256|OTHER||Geometric Least-squares Mean Ratio|118.0|||||TWO_SIDED|90.0|80.3|172.0|||||Parametric (normal theory) mixed-effects ANOVA model was fitted to the natural log-transformed values of the PK parameter under evaluation.|||172|80.3|
72431633|NCT05458102|144375258|OTHER||Geometric Least-squares Mean Ratio|68.5|||||TWO_SIDED|90.0|45.5|103.0|||||Parametric (normal theory) mixed-effects ANOVA model was fitted to the natural log-transformed values of the PK parameter under evaluation.|||103|45.5|
72431634|NCT05458102|144375258|OTHER||Geometric Least-squares Mean Ratio|65.4|||||TWO_SIDED|90.0|42.5|101.0|||||Parametric (normal theory) mixed-effects ANOVA model was fitted to the natural log-transformed values of the PK parameter under evaluation.|||101|42.5|
72431635|NCT05458102|144375262|OTHER||Geometric Least-squares Mean Ratio|120.0|||||TWO_SIDED|90.0|104.0|138.0|||||Parametric (normal theory) mixed-effects ANOVA model was fitted to the natural log-transformed values of the PK parameter under evaluation.|||138|104|
72431636|NCT05458102|144375262|OTHER||Geometric Least-squares Mean Ratio|111.0|||||TWO_SIDED|90.0|95.4|128.0|||||Parametric (normal theory) mixed-effects ANOVA model was fitted to the natural log-transformed values of the PK parameter under evaluation.|||128|95.4|
72364349|NCT04363320|144240713|SUPERIORITY||Slope|0.073|STANDARD_DEVIATION|0.031||0.02|TWO_SIDED|||||a priori threshold: 0.05|Mixed Models Analysis||Slope is per month.|Change in census patient counts (Naltrexone) for Intervention Phase (from baseline to 12 months)||||0.020
72364350|NCT04363320|144240714|SUPERIORITY||Slope|0.617|STANDARD_DEVIATION|0.307||0.045|TWO_SIDED|||||a priori threshold: 0.05|Mixed Models Analysis||Slope is per month.|Change in census patient counts (Combined MOUD) for Sustainability Phase (from 13 to 24 months)||||0.045
72364351|NCT04363320|144240714|SUPERIORITY||Slope|1.103|STANDARD_DEVIATION|0.229||2e-06|TWO_SIDED|||||a priori threshold: 0.05|Mixed Models Analysis||Slope is per month.|Change in census patient counts (Buprenorphine) for Sustainability Phase (from 13 to 24 months)||||0.000002
72364352|NCT04363320|144240714|SUPERIORITY||Slope|-0.387|STANDARD_DEVIATION|0.218||0.076|TWO_SIDED|||||a priori threshold: 0.05|Mixed Models Analysis||Slope is per month|Change in census patient counts (Methadone) for Sustainability Phase (13 to 24 months)||||0.076
72364353|NCT04363320|144240714|SUPERIORITY||Slope|0.086|STANDARD_DEVIATION|0.036||0.019|TWO_SIDED|||||a priori threshold: 0.05|Mixed Models Analysis||Slope is per month.|Change in census patient counts (Naltrexone) for Sustainability Phase (from 13 to 24 months)||||0.019
72364354|NCT00541658|144240720|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|-0.233|||||TWO_SIDED|95.0|-0.812|0.345|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||0.345|-0.812|
72364355|NCT00541658|144240720|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|-0.296|||||TWO_SIDED|95.0|-0.869|0.277|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||0.277|-0.869|
72364356|NCT00541658|144240721|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|-0.265||||0.2955|TWO_SIDED|95.0|-0.763|0.232|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant used.|LS Mean Difference is 5 mg daily minus weekly treatment.|||0.232|-0.763|0.2955
72364357|NCT00541658|144240722|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|-0.131|||||TWO_SIDED|95.0|-0.674|0.412|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||0.412|-0.674|
72364358|NCT00541658|144240722|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|0.156|||||TWO_SIDED|95.0|-0.382|0.695|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||0.695|-0.382|
72364359|NCT00541658|144240723|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|-0.258|||||TWO_SIDED|95.0|-0.836|0.321|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||0.321|-0.836|
72364360|NCT00541658|144240723|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|-0.322|||||TWO_SIDED|95.0|-0.9|0.256|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||0.256|-0.900|
72364361|NCT00541658|144240724|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|LS Mean Difference|-1.154|||||TWO_SIDED|95.0|-1.903|-0.405|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||-0.405|-1.903|
72431637|NCT02092987|144375270|SUPERIORITY_OR_OTHER_LEGACY||interaction term|||||0.7|||||||Mixed Models Analysis|||Hypothesis testing in changes in mean from baseline to follow-up were were conducted primarily with mixed models. Sensitivity analyses were conducted using ANOVA.||||0.70
72431638|NCT02092987|144375271|SUPERIORITY_OR_OTHER_LEGACY|||||||0.77||||||comparison of arms using mixed models|Mixed Models Analysis|||||||0.77
72364362|NCT00541658|144240724|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|LS Mean Difference|-1.044|||||TWO_SIDED|95.0|-1.789|-0.299|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||-0.299|-1.789|
72364363|NCT00541658|144240725|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|LS Mean Difference|-1.059|||||TWO_SIDED|95.0|-1.762|-0.355|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||-0.355|-1.762|
72364364|NCT00541658|144240725|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|LS Mean Difference|-0.922|||||TWO_SIDED|95.0|-1.62|-0.223|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||-0.223|-1.620|
72364365|NCT00541658|144240726|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Relative Risk|1.08||||0.0524|TWO_SIDED|95.0|1.0|1.16|||Fisher Exact|||||1.16|1.00|0.0524
72364366|NCT00541658|144240726|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Relative Risk|1.07||||0.1207|TWO_SIDED|95.0|0.99|1.15|||Fisher Exact|||||1.15|0.99|0.1207
72364367|NCT00541658|144240727|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Relative Risk|1.07||||0.0729|TWO_SIDED|95.0|1.0|1.15|||Fisher Exact|||||1.15|1.00|0.0729
72364368|NCT00541658|144240727|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Relative Risk|1.06||||0.1639|TWO_SIDED|95.0|0.98|1.14|||Fisher Exact|||||1.14|0.98|0.1639
72364369|NCT00541658|144240728|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Relative Risk|1.08||||0.0476|TWO_SIDED|95.0|1.0|1.16|||Fisher Exact|||||1.16|1.00|0.0476
72364370|NCT00541658|144240728|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Relative Risk|1.12||||0.0014|TWO_SIDED|95.0|1.04|1.2|||ANOVA|||||1.20|1.04|0.0014
72364371|NCT00541658|144240729|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Relative Risk|1.08||||0.0547|TWO_SIDED|95.0|1.0|1.16|||ANOVA|||||1.16|1.00|0.0547
72364372|NCT00541658|144240729|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Relative Risk|1.1||||0.0066|TWO_SIDED|95.0|1.03|1.18|||ANOVA|||||1.18|1.03|0.0066
72368806|NCT02637037|144247320|NON_INFERIORITY_OR_EQUIVALENCE|If the 90% CIs for both dapagliflozin and metformin geometric mean ratio of AUC is entirely contained within an 80.00% to 125.00% interval, it will be concluded the 2 manufacturing sites are bioequivalent.|Ratios of Geometric means|0.99|||||TWO_SIDED|90.0|0.97|1.02||||||Dapagliflozin: Statistical Assessment of Bioequivalence for Dapagliflozin following administration Dapagliflozin/Metformin XR 5/500 mg for Treatment C and D.||1.02|0.97|
72364373|NCT00541658|144240730|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|-0.135|||||TWO_SIDED|95.0|-0.504|0.234|||ANOVA|Fixed effect for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||0.234|-0.504|
72364374|NCT00541658|144240730|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|-0.072|||||TWO_SIDED|95.0|-0.437|0.294|||ANOVA|Fixed effect for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||0.294|-0.437|
72364375|NCT00541658|144240731|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|-0.321|||||TWO_SIDED|95.0|-0.724|0.082|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||0.082|-0.724|
72364376|NCT00541658|144240731|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|-0.29|||||TWO_SIDED|95.0|-0.692|0.112|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||0.112|-0.692|
72364377|NCT00541658|144240732|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|-0.288|||||TWO_SIDED|95.0|-0.682|0.106|||ANOVA|Fixed effect for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||0.106|-0.682|
72364378|NCT00541658|144240732|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|-0.29|||||TWO_SIDED|95.0|-0.681|0.101|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||0.101|-0.681|
72364379|NCT00541658|144240733|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|LS Mean Difference|-0.644|||||TWO_SIDED|95.0|-1.179|-0.11|||ANOVA|||||-0.110|-1.179|
72364380|NCT00541658|144240733|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|LS Mean Difference|-0.587|||||TWO_SIDED|95.0|-1.116|-0.059|||ANOVA|||||-0.059|-1.116|
72364381|NCT00541658|144240734|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|LS Mean Difference|-0.522|||||TWO_SIDED|95.0|-1.03|-0.014|||ANOVA|||||-0.014|-1.030|
72364382|NCT00541658|144240734|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|LS Mean Difference|-0.468|||||TWO_SIDED|95.0|-0.973|0.037|||ANOVA|||||0.037|-0.973|
72364383|NCT00541658|144240735|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|-0.265|||||TWO_SIDED|95.0|-0.731|0.201|||ANOVA|Fixed effects for treatment, pooled centers and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||0.201|-0.731|
72431639|NCT02092987|144375272|SUPERIORITY_OR_OTHER_LEGACY|||||||0.51|||||||Mixed Models Analysis|||||||0.51
72364384|NCT00541658|144240735|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|-0.126|||||TWO_SIDED|95.0|-0.588|0.336|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||0.336|-0.588|
72364385|NCT00541658|144240736|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|-0.328|||||TWO_SIDED|95.0|-0.811|0.156|||ANOVA|Fixed effects for treatment, pooled centers and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||0.156|-0.811|
72364386|NCT00541658|144240736|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|-0.563|||||TWO_SIDED|95.0|-1.045|-0.08|||ANOVA|Fixed effects for treatment, pooled center, anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||-0.080|-1.045|
72364387|NCT00541658|144240737|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|-0.327|||||TWO_SIDED|95.0|-0.793|0.138|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||0.138|-0.793|
72364388|NCT00541658|144240737|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|-0.537|||||TWO_SIDED|95.0|-1.0|-0.074|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||-0.074|-1.000|
72364389|NCT00541658|144240738|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|LS Mean Difference|-0.578|||||TWO_SIDED|95.0|-1.189|0.032|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||0.032|-1.189|
72364390|NCT00541658|144240738|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|LS Mean Difference|-0.799|||||TWO_SIDED|95.0|-1.403|-0.194|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||-0.194|-1.403|
72364391|NCT00541658|144240739|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|LS Mean Difference|-0.555|||||TWO_SIDED|95.0|-1.128|0.018|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||0.018|-1.128|
72364392|NCT00541658|144240739|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|LS Mean Difference|-0.616|||||TWO_SIDED|95.0|-1.185|-0.046|||ANOVA|Fixed effect for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||-0.046|-1.185|
72364393|NCT00541658|144240740|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|-0.249|||||TWO_SIDED|95.0|-0.86|0.363|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||0.363|-0.860|
72431640|NCT02092987|144375273|SUPERIORITY_OR_OTHER_LEGACY|||||||0.51|||||||Mixed Models Analysis|||||||0.51
72431641|NCT02092987|144375274|SUPERIORITY_OR_OTHER_LEGACY|||||||0.76|||||||Mixed Models Analysis|||||||0.76
72431642|NCT02092987|144375275|SUPERIORITY_OR_OTHER_LEGACY|||||||0.79|||||||Mixed Models Analysis|||||||0.79
72364394|NCT00541658|144240740|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|-0.265|||||TWO_SIDED|95.0|-0.871|0.342|||ANOVA|Fixed effect for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||0.342|-0.871|
72364395|NCT00541658|144240741|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|-0.557|||||TWO_SIDED|95.0|-1.185|0.071|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||0.071|-1.185|
72364396|NCT00541658|144240741|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|-0.522|||||TWO_SIDED|95.0|-1.149|0.105|||ANOVA||LS Mean Difference is 5 mg daily minus weekly treatment.|||0.105|-1.149|
72364397|NCT00541658|144240742|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|-0.546|||||TWO_SIDED|95.0|-1.17|0.078|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||0.078|-1.170|
72364398|NCT00541658|144240742|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|-0.579|||||TWO_SIDED|95.0|-1.199|0.042|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||0.042|-1.199|
72364399|NCT00541658|144240743|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|LS Mean Difference|-1.095|||||TWO_SIDED|95.0|-1.861|-0.329|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||-0.329|-1.861|
72364400|NCT00541658|144240743|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|LS Mean Difference|-1.19|||||TWO_SIDED|95.0|-1.948|-0.432|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||-0.432|-1.948|
72364401|NCT00541658|144240744|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|LS Mean Difference|-0.919|||||TWO_SIDED|95.0|-1.655|-0.184|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||-0.184|-1.655|
72364402|NCT00541658|144240744|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|LS Mean Difference|-1.056|||||TWO_SIDED|95.0|-1.787|-0.326|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||-0.326|-1.787|
72364403|NCT00541658|144240745|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|3.771|||||TWO_SIDED|95.0|-0.885|8.427|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||8.427|-0.885|
72368807|NCT02637037|144247320|NON_INFERIORITY_OR_EQUIVALENCE|If the 90% CIs for both dapagliflozin and metformin geometric mean ratio of AUC is entirely contained within an 80.00% to 125.00% interval, it will be concluded the 2 manufacturing sites are bioequivalent.|Ratios of Geometric means|0.96|||||TWO_SIDED|90.0|0.93|0.98||||||Dapagliflozin: Statistical Assessment of Bioequivalence for Dapagliflozin following administration Dapagliflozin/Metformin XR 10/1000 mg for Treatment E and F.||0.98|0.93|
72364404|NCT00541658|144240745|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|2.826|||||TWO_SIDED|95.0|-1.819|7.471|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||7.471|-1.819|
72364405|NCT00541658|144240746|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|2.63|||||TWO_SIDED|95.0|-2.171|7.431|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||7.431|-2.171|
72364406|NCT00541658|144240746|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|4.617|||||TWO_SIDED|95.0|-0.152|9.386|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||9.386|-0.152|
72364407|NCT00541658|144240747|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|5.04|||||TWO_SIDED|95.0|0.091|9.989|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||9.989|0.091|
72364408|NCT00541658|144240747|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|4.64|||||TWO_SIDED|95.0|-0.293|9.574|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||9.574|-0.293|
72364409|NCT00541658|144240748|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|6.372|||||TWO_SIDED|95.0|1.329|11.414|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||11.414|1.329|
72364410|NCT00541658|144240748|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|4.403|||||TWO_SIDED|95.0|-0.619|9.425|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||9.425|-0.619|
72364411|NCT00541658|144240749|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|LS Mean Difference|4.739|||||TWO_SIDED|95.0|-0.793|10.271|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||10.271|-0.793|
72364412|NCT00541658|144240749|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|LS Mean Difference|3.999|||||TWO_SIDED|95.0|-1.518|9.515|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||9.515|-1.518|
72364413|NCT00541658|144240750|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|LS Mean Difference|4.817|||||TWO_SIDED|95.0|-0.693|10.327|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||10.327|-0.693|
72431643|NCT02092987|144375276|SUPERIORITY_OR_OTHER_LEGACY|||||||0.62|||||||Mixed Models Analysis|||||||0.62
72364414|NCT00541658|144240750|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|LS Mean Difference|3.192|||||TWO_SIDED|95.0|-2.295|8.68|||ANOVA|Fixed effects for treatment, pooled centers and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||8.680|-2.295|
72364415|NCT00541658|144240751|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|4.45|||||TWO_SIDED|95.0|-0.26|9.16|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||9.160|-0.260|
72364416|NCT00541658|144240751|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|3.723|||||TWO_SIDED|95.0|-0.975|8.421|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||8.421|-0.975|
72364417|NCT00541658|144240752|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|4.798|||||TWO_SIDED|95.0|-0.195|9.79|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||9.790|-0.195|
72364418|NCT00541658|144240752|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|4.972|||||TWO_SIDED|95.0|0.02|9.924|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||9.924|0.020|
72364419|NCT00541658|144240753|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|4.775|||||TWO_SIDED|95.0|-0.514|10.065|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||10.065|-0.514|
72364420|NCT00541658|144240753|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|5.638||||||95.0|0.356|10.92|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||10.920|0.356|
72364421|NCT00541658|144240754|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|6.552|||||TWO_SIDED|95.0|1.162|11.942|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||11.942|1.162|
72364422|NCT00541658|144240754|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|5.531|||||TWO_SIDED|95.0|0.164|10.897|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||10.897|0.164|
72364423|NCT00541658|144240755|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|LS Mean Difference|7.83|||||TWO_SIDED|95.0|1.175|14.485|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||14.485|1.175|
72364424|NCT00541658|144240755|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|LS Mean Difference|8.383|||||TWO_SIDED|95.0|1.757|15.01|||ANOVA|Fixed effects for treatment, pooled centers and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||15.010|1.757|
72364425|NCT00541658|144240756|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|LS Mean Difference|7.802|||||TWO_SIDED|95.0|1.385|14.22|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||14.220|1.385|
72364426|NCT00541658|144240756|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|LS Mean Difference|7.301|||||TWO_SIDED|95.0|0.911|13.69|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||13.690|0.911|
72364427|NCT00541658|144240757|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|1.755|||||TWO_SIDED|95.0|-1.145|4.655|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||4.655|-1.145|
72364428|NCT00541658|144240757|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|1.805|||||TWO_SIDED|95.0|-1.087|4.698|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||4.698|-1.087|
72364429|NCT00541658|144240758|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|2.407|||||TWO_SIDED|95.0|-0.502|5.316|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||5.316|-0.502|
72364430|NCT00541658|144240758|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|1.309|||||TWO_SIDED|95.0|-1.576|4.194|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||4.194|-1.576|
72364431|NCT00541658|144240759|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|1.555|||||TWO_SIDED|95.0|-1.617|4.727|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||4.727|-1.617|
72364432|NCT00541658|144240759|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|1.612|||||TWO_SIDED|95.0|-1.556|4.779|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||4.779|-1.556|
72364433|NCT00541658|144240760|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|1.434|||||TWO_SIDED|95.0|-1.652|4.521|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||4.521|-1.652|
72364434|NCT00541658|144240760|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|1.462|||||TWO_SIDED|95.0|-1.611|4.535|||ANOVA|Fixed effect for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||4.535|-1.611|
72364435|NCT00541658|144240761|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|LS Mean Difference|2.749|||||TWO_SIDED|95.0|-0.938|6.436|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||6.436|-0.938|
72364436|NCT00541658|144240761|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|LS Mean Difference|3.416|||||TWO_SIDED|95.0|-0.255|7.087|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus daily treatment.|||7.087|-0.255|
72364437|NCT00541658|144240762|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|LS Mean Difference|2.197|||||TWO_SIDED|95.0|-1.318|5.711|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||5.711|-1.318|
72364438|NCT00541658|144240762|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|LS Mean Difference|2.251|||||TWO_SIDED|95.0|-1.248|5.751|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||5.751|-1.248|
72364439|NCT00541658|144240763|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Relative Risk|1.0||||1|TWO_SIDED|95.0|0.14|7.05|||Fisher Exact|||||7.05|0.14|1.0000
72364440|NCT00541658|144240763|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Relative Risk|1.5||||1|TWO_SIDED|95.0|0.25|8.9|||Fisher Exact|||||8.90|0.25|1.0000
72364441|NCT00541658|144240764|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Relative Risk|1.03||||1|TWO_SIDED|95.0|0.15|7.29|||Fisher Exact|||||7.29|0.15|1.0000
72364442|NCT00541658|144240764|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Relative Risk|1.49||||1|TWO_SIDED|95.0|0.25|8.87|||Fisher Exact|||||8.87|0.25|1.0000
72364443|NCT00541658|144240765|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Relative Risk|0.42||||0.4505|TWO_SIDED|95.0|0.08|2.14|||Fisher Exact|||||2.14|0.08|0.4505
72364444|NCT00541658|144240765|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Relative Risk|0.82||||1|TWO_SIDED|95.0|0.22|3.03|||Fisher Exact|||||3.03|0.22|1.0000
72364445|NCT00541658|144240766|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Relative Risk|0.41||||0.4505|TWO_SIDED|95.0|0.08|2.11|||Fisher Exact|||||2.11|0.08|0.4505
72364446|NCT00541658|144240766|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Relative Risk|1.2||||0.7719|TWO_SIDED|95.0|0.37|3.9|||Fisher Exact|||||3.90|0.37|0.7719
72364447|NCT00541658|144240767|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Relative Risk|1.0||||1|TWO_SIDED|95.0|0.14|7.05|||Fisher Exact|||||7.05|0.14|1.0000
72364448|NCT00541658|144240767|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Relative Risk|1.5||||1|TWO_SIDED|95.0|0.25|8.9|||Fisher Exact|||||8.90|0.25|1.0000
72364449|NCT00541658|144240768|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Relative Risk|1.03||||1|TWO_SIDED|95.0|0.15|7.29|||Fisher Exact|||||7.29|0.15|1.0000
72364450|NCT00541658|144240768|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Relative Risk|1.49||||1|TWO_SIDED|95.0|0.25|8.87|||Fisher Exact|||||8.87|0.25|1.0000
72364451|NCT00541658|144240769|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Relative Risk|0.42||||0.4505|TWO_SIDED|95.0|0.08|2.14|||Fisher Exact|||||2.14|0.08|0.4505
72364452|NCT00541658|144240769|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Relative Risk|0.82||||1|TWO_SIDED|95.0|0.22|3.03|||Fisher Exact|||||3.03|0.22|1.0000
72364453|NCT00541658|144240770|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Relative Risk|0.41||||0.4505|TWO_SIDED|95.0|0.08|2.11|||Fisher Exact|||||2.11|0.08|0.4505
72364454|NCT00541658|144240770|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Relative Risk|1.2||||0.7719|TWO_SIDED|95.0|0.37|3.9|||Fisher Exact|||||3.90|0.37|0.7719
72364455|NCT02344108|144240810|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
72364456|NCT02344108|144240811|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
72364457|NCT02344108|144240812|SUPERIORITY|||||||0.035|||||||t-test, 2 sided|||||||0.035
72364458|NCT02344108|144240813|SUPERIORITY|||||||0.083|||||||t-test, 2 sided|||||||0.083
72364459|NCT02344108|144240814|SUPERIORITY|||||||0.0021|||||||t-test, 2 sided|||||||0.0021
72364460|NCT02344108|144240815|SUPERIORITY|||||||0.764|||||||t-test, 2 sided|||||||0.764
72364461|NCT02344108|144240816|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
72364462|NCT02344108|144240817|SUPERIORITY|||||||0.467|||||||t-test, 2 sided|||||||0.467
72364463|NCT02344108|144240818|SUPERIORITY|||||||0.745|||||||t-test, 2 sided|||||||0.745
72364464|NCT02344108|144240819|SUPERIORITY|||||||0.106|||||||t-test, 2 sided|||||||0.106
72364465|NCT02344108|144240820|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
72364466|NCT02344108|144240821|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
72364467|NCT02344108|144240822|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
72364468|NCT00911170|144240846|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.41||||0.014|TWO_SIDED|95.0|0.19|0.86|||Cochran-Mantel-Haenszel|The p-value is adjusted for the randomization stratification factors (chemotherapy regimen, geographic region, disease stage).|Odds ratio adjusted for the randomization stratification factors. An OR \< 1.0 indicates a lower event rate for the pegfilgrastim arm relative to the placebo arm.|The primary hypothesis was that the percentage of participants treated with study chemotherapy and bevacizumab who experience grade 3/4 febrile neutropenia (FN) would be lower in participants randomized to the pegfilgrastim arm compared to placebo arm. The study was designed to have at least 90% power at the 2-sided 0.05 significance level to detect a 6% difference in incidence of grade 3/4 FN from 9% to 3%, which is approximately a 66.7% relative reduction.||0.86|0.19|0.014
72364469|NCT00911170|144240847|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.05||||0.704|TWO_SIDED|95.0|0.81|1.36|||Log Rank|P-values based on the log-rank test statistic from the Kaplan-Meier survival analysis stratified by the 3 randomization factors.|Based on Cox proportional Hazard model stratified by chemotherapy regimen, region and disease status. A HR\< 1.0 indicates a lower average event rate and a longer survival time for the pegfilgrastim arm relative to the placebo arm.|||1.36|0.81|0.704
72364470|NCT00911170|144240848|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.05||||0.552|TWO_SIDED|95.0|0.88|1.26|||Log Rank|P-values are based on the log-rank test statistic from the Kaplan-Meier survival analysis stratified by the 3 randomization factors.|Based on Cox proportional Hazard model stratified by chemotherapy regimen, region and disease status. A HR\< 1.0 indicates a lower average event rate and a longer survival time for the pegfilgrastim arm relative to the placebo arm.|||1.26|0.88|0.552
72364471|NCT00911170|144240849|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.07||||0.502|TWO_SIDED|95.0|0.88|1.29|||Log Rank|P-values are based on the log-rank test statistic from the Kaplan-Meier survival analysis stratified by the 3 randomization factors.|Based on Cox proportional Hazard model stratified by chemotherapy regimen, region and disease status. A HR\< 1.0 indicates a lower average event rate and a longer survival time for the pegfilgrastim arm relative to the placebo arm.|||1.29|0.88|0.502
72364472|NCT00911170|144240850|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.06||||0.683|TWO_SIDED|95.0|0.81|1.39|||Cochran-Mantel-Haenszel|The p-value is from the Cochran Mantel Haenszel (CMH) test adjusting for the randomization stratification factors.|Odds ratio (OR) adjusted for the randomization stratification factors. An OR \> 1.0 indicates a higher event rate for the pegfilgrastim arm relative to the placebo arm.|||1.39|0.81|0.683
72364473|NCT00911170|144240851|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.66||||0.312||95.0|0.29|1.49|||Cochran-Mantel-Haenszel|The p-value is from the Cochran Mantel Haenszel (CMH) test adjusting for the randomization stratification factors.|Odds ratio (OR) adjusted for the randomization stratification factors. An OR \< 1.0 indicates a lower event rate for the pegfilgrastim arm relative to the placebo arm.|||1.49|0.29|0.312
72364474|NCT00911170|144240852|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.18|||<|0.001||95.0|0.1|0.32|||Cochran-Mantel-Haenszel|The p-value is from the Cochran Mantel Haenszel (CMH) test adjusting for the randomization stratification factors.|Odds ratio (OR) adjusted for the randomization stratification factors. An OR \< 1.0 indicates a lower event rate for the pegfilgrastim arm relative to the placebo arm.|||0.32|0.10|<.001
72364475|NCT00911170|144240853|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.27|||<|0.001|TWO_SIDED|95.0|0.13|0.56|||Cochran-Mantel-Haenszel|The p-value is from the Cochran Mantel Haenszel (CMH) test adjusting for the randomization stratification factors.|Odds ratio (OR) adjusted for the randomization stratification factors. An OR \< 1.0 indicates a lower event rate for the pegfilgrastim arm relative to the placebo arm.|||0.56|0.13|<.001
72364476|NCT00664443|144240887|OTHER||Sensitivity|65.9|||||TWO_SIDED|95.0|63.5|68.2||||||||68.2|63.5|
72364477|NCT00664443|144240888|OTHER||Specificity|32.3|||||TWO_SIDED|95.0|29.0|35.9||||||||35.9|29.0|
72364478|NCT04684836|144240910|SUPERIORITY|The analysis leveraged a difference-in-differences research design in an intent-to-treat framework, comparing outcomes for patients receiving care at high-telehealth practices with patients at comparable low-telehealth practices, before relative to after the onset of the pandemic (when telehealth use increased significantly).|Mean Difference (Net)|-0.0255||||0.0793|TWO_SIDED||||||Regression, Linear|All models included practice and year-quarter fixed effects, and clustered standard errors at the practice level.|This is the Unadjusted model, which included only an indicator for high telemedicine practice, post-period, and its two-way interaction.|||||0.0793
72364479|NCT04684836|144240910|SUPERIORITY|Difference-in-differences model|Mean Difference (Net)|-0.0786||||0.5739|TWO_SIDED|||||This is the fully adjusted regression model, which controlled for patient age group, gender, dual status, race, average percent of 65+ patients, risk score category, rural vs urban, and zip-code level characteristics.|Regression, Linear|||||||0.5739
72364480|NCT04684836|144240911|SUPERIORITY||Mean Difference (Net)|-0.0014||||0.3261|TWO_SIDED|||||This is an adjusted model, which included only an indicator for high telemedicine practice, post-period, and its two-way interaction.|Regression, Linear|||Difference-in-differences model||||0.3261
72364481|NCT04684836|144240911|SUPERIORITY||Mean Difference (Net)|0.0806|||<|0.01|TWO_SIDED|||||This is a fully adjusted regression model, which controlled for patient age group, gender, dual status, race, average percent of 65+ patients, risk score category, rural vs urban, and zip-code level characteristics.|Regression, Linear|||Difference-in-differences model||||<0.01
72364482|NCT04684836|144240912|SUPERIORITY||Mean Difference (Net)|-0.0217||||0.1101|TWO_SIDED|||||This is an adjusted unadjusted model, which included only an indicator for high telemedicine practice, post-period, and its two-way interaction.|Regression, Linear|||Difference-in-differences||||0.1101
72364483|NCT04684836|144240912|SUPERIORITY||Mean Difference (Net)|0.5551||||0.4618|TWO_SIDED|||||This is a fully adjusted regression model, which controlled for patient age group, gender, dual status, race, average percent of 65+ patients, risk score category, rural vs urban, and zip-code level characteristics.|Regression, Linear|||Difference-in-differences||||0.4618
72364484|NCT04684836|144240914|SUPERIORITY||Mean Difference (Net)|-0.0012||||0.8577|TWO_SIDED|||||This is an unadjusted model, which included only an indicator for high telemedicine practice, post-period, and its two-way interaction|Regression, Linear|||Difference-in-differences||||0.8577
72364485|NCT04684836|144240914|SUPERIORITY||Mean Difference (Net)|0.2014||||0.5954|TWO_SIDED|||||This is the fully adjusted regression model, which controlled for patient age group, gender, dual status, race, average percent of 65+ patients, risk score category, rural vs urban, and zip-code level characteristics.|Regression, Linear|||Difference-in-differences||||0.5954
72364486|NCT02141295|144240970|OTHER||Hazard Ratio (HR)|0.91|||=|0.6753|TWO_SIDED|95.0|0.6|1.39||log-rank|Regression, Cox|||Kaplan-Meier methods were used to estimate median PFS for each treatment arm and the 95% CIs for median PFS were computed using the Brookmeyer and Crowley method. The stratified Cox proportional hazard was used to estimate the hazard ratio (i.e., the magnitude of the treatment effect) and the corresponding 95% confidence interval. The stratification factors are number of metastatic sites (1 vs. \>1) and country/region (USA vs rest of the world).||1.39|0.60|= 0.6753
72364487|NCT02141295|144240973|OTHER||Hazard Ratio (HR)|0.85|||=|0.574|TWO_SIDED|95.0|0.49|1.49|||Log Rank|||Kaplan-Meier methods were used to estimate median OS for each treatment arm and the 95% CIs for median OS were computed using the Brookmeyer and Crowley method. The stratified Cox proportional hazard was used to estimate the hazard ratio (i.e., the magnitude of the treatment effect) and the corresponding 95% confidence interval. The stratification factors are number of metastatic sites (1 vs. \>1) and country/region (USA vs rest of the world).||1.49|0.49|= 0.5740
72364488|NCT00071890|144240995|SUPERIORITY_OR_OTHER|||||||0.025||95.0|||||Chi-squared|||||||0.025
72364489|NCT00071890|144240996|SUPERIORITY_OR_OTHER|||||||0.069||95.0||||Biphasic decline of CD4 after week 24 : first slope before W32 and weaker decline until W168.Slopes significantly different (all p values ≤0.0001) between the 2 groups, more pronounced in the IL-2 groups|Wilcoxon (Mann-Whitney)|||||||0.069
72364490|NCT02144610|144241007|SUPERIORITY_OR_OTHER||||||>|0.999|||||||Fisher Exact|||MI at 0-6 Months||||>0.999
72364491|NCT02144610|144241007|SUPERIORITY_OR_OTHER|||||||0.4889|||||||Fisher Exact|||MI at 0-12 Months||||0.4889
72364492|NCT02144610|144241007|SUPERIORITY_OR_OTHER|||||||0.4889|||||||Fisher Exact|||MI at 0-18 Months||||0.4889
72364493|NCT02144610|144241007|SUPERIORITY_OR_OTHER||||||>|0.999|||||||Fisher Exact|||Stroke at 0-6 Months||||>0.999
72364494|NCT02144610|144241007|SUPERIORITY_OR_OTHER||||||>|0.999|||||||Fisher Exact|||Stroke at 0-12 Months||||>0.999
72364495|NCT02144610|144241007|SUPERIORITY_OR_OTHER||||||>|0.999|||||||Fisher Exact|||Stroke at 0-18 Months||||>0.999
72364496|NCT02144610|144241007|SUPERIORITY_OR_OTHER|||||||0.7381|||||||Fisher Exact|||Major amputation at 0-6 Months||||0.7381
72364497|NCT02144610|144241007|SUPERIORITY_OR_OTHER||||||>|0.999|||||||Fisher Exact|||Major amputation at 0-12 Months||||>0.999
72364498|NCT02144610|144241007|SUPERIORITY_OR_OTHER||||||>|0.999|||||||Fisher Exact|||Major amputation at 0-18 Months||||>0.999
72364499|NCT02144610|144241007|SUPERIORITY_OR_OTHER||||||>|0.999|||||||Fisher Exact|||Revascularization at 0-6 Months||||>0.999
72364500|NCT02144610|144241007|SUPERIORITY_OR_OTHER|||||||0.4591|||||||Fisher Exact|||Revascularization at 0-12 Months||||0.4591
72364501|NCT02144610|144241007|SUPERIORITY_OR_OTHER|||||||0.4591|||||||Fisher Exact|||Revascularization at 0-18 Months||||0.4591
72364502|NCT02144610|144241007|SUPERIORITY_OR_OTHER||||||>|0.999|||||||Fisher Exact|||All-cause death at 0-6 Months||||>0.999
72364503|NCT02144610|144241007|SUPERIORITY_OR_OTHER||||||>|0.999|||||||Fisher Exact|||All-cause death at 0-12 Months||||>0.999
72364504|NCT02144610|144241007|SUPERIORITY_OR_OTHER||||||>|0.999|||||||Fisher Exact|||All-cause death at 0-18 Months||||>0.999
72364505|NCT02144610|144241007|SUPERIORITY_OR_OTHER|||||||0.5136|||||||Fisher Exact|||0-6 Months (Major Amputation or Death)||||0.5136
72364506|NCT02144610|144241007|SUPERIORITY_OR_OTHER|||||||0.7575|||||||Fisher Exact|||0-12 Months (Major Amputation or Death)||||0.7575
72364507|NCT02144610|144241007|SUPERIORITY_OR_OTHER||||||>|0.999|||||||Fisher Exact|||0-18 Months (Major Amputation or Death)||||>0.999
72364508|NCT02144610|144241007|SUPERIORITY_OR_OTHER|||||||0.7575|||||||Fisher Exact|||0-6 Months (Major Amputation or Revascularization)||||0.7575
72364509|NCT02144610|144241007|SUPERIORITY_OR_OTHER||||||>|0.999|||||||Fisher Exact|||0-12 Months (Major Amputation or Revascularization)||||>0.999
72364510|NCT02144610|144241007|SUPERIORITY_OR_OTHER||||||>|0.999|||||||Fisher Exact|||0-18 Months (Major Amputation or Revascularization)||||>0.999
72364511|NCT02144610|144241008|SUPERIORITY_OR_OTHER|||||||0.514|||||||ANCOVA|||Change from Baseline at Month 3||||0.514
72364512|NCT02144610|144241008|SUPERIORITY_OR_OTHER|||||||0.445|||||||ANCOVA|||Change from Baseline at Month 6||||0.445
72364513|NCT02144610|144241008|SUPERIORITY_OR_OTHER|||||||0.863|||||||ANCOVA|||Change from Baseline at Month 9||||0.863
72364514|NCT02144610|144241008|SUPERIORITY_OR_OTHER|||||||0.111|||||||ANCOVA|||Change from Baseline at Month 12||||0.111
72364515|NCT02144610|144241008|SUPERIORITY_OR_OTHER|||||||0.153|||||||ANCOVA|||Change from Baseline at Month 15||||0.153
72364516|NCT02144610|144241008|SUPERIORITY_OR_OTHER|||||||0.002|||||||ANCOVA|||Change from Baseline at last observation carried forward (LOCF)||||0.002
72364517|NCT02144610|144241011|SUPERIORITY_OR_OTHER|||||||0.733|||||||ANCOVA|||Change from baseline at Month 3 (right brachial)||||0.733
72364518|NCT02144610|144241011|SUPERIORITY_OR_OTHER|||||||0.808|||||||ANCOVA|||Change from baseline at Month 6 (right brachial)||||0.808
72364519|NCT02144610|144241011|SUPERIORITY_OR_OTHER|||||||0.487|||||||ANCOVA|||Change from baseline at Month 9 (right brachial)||||0.487
72364520|NCT02144610|144241011|SUPERIORITY_OR_OTHER|||||||0.216|||||||ANCOVA|||Change from baseline at Month 12 (right brachial)||||0.216
72364521|NCT02144610|144241011|SUPERIORITY_OR_OTHER|||||||0.896|||||||ANCOVA|||Change from baseline at Month 15 (right brachial)||||0.896
72364522|NCT02144610|144241011|SUPERIORITY_OR_OTHER|||||||0.167|||||||ANCOVA|||Change from baseline at last observation carried forward (LOCF) (right brachial)||||0.167
72364523|NCT02144610|144241011|SUPERIORITY_OR_OTHER|||||||0.378|||||||ANCOVA|||Change from baseline at Month 3 (left brachial)||||0.378
72364524|NCT02144610|144241011|SUPERIORITY_OR_OTHER|||||||0.39|||||||ANCOVA|||Change from baseline at Month 6 (left brachial)||||0.390
72364525|NCT02144610|144241011|SUPERIORITY_OR_OTHER|||||||0.521|||||||ANCOVA|||Change from baseline at Month 9 (left brachial)||||0.521
72364526|NCT02144610|144241011|SUPERIORITY_OR_OTHER|||||||0.044|||||||ANCOVA|||Change from baseline at Month 12 (left brachial)||||0.044
72364527|NCT02144610|144241011|SUPERIORITY_OR_OTHER|||||||0.423|||||||ANCOVA|||Change from baseline at Month 15 (left brachial)||||0.423
72364528|NCT02144610|144241011|SUPERIORITY_OR_OTHER|||||||0.989|||||||ANCOVA|||Change from baseline at LOCF (left brachial)||||0.989
72364529|NCT02144610|144241012|SUPERIORITY_OR_OTHER|||||||0.803|||||||ANCOVA|||Change from Baseline at Month 3 (Dorsalis Pedis)||||0.803
72364530|NCT02144610|144241012|SUPERIORITY_OR_OTHER|||||||0.668|||||||ANCOVA|||Change from Baseline at Month 6 (Dorsalis Pedis)||||0.668
72364531|NCT02144610|144241012|SUPERIORITY_OR_OTHER|||||||0.789|||||||ANCOVA|||Change from Baseline at Month 9 (Dorsalis Pedis)||||0.789
72364532|NCT02144610|144241012|SUPERIORITY_OR_OTHER|||||||0.28|||||||ANCOVA|||Change from Baseline at Month 12 (Dorsalis Pedis)||||0.280
72364533|NCT02144610|144241012|SUPERIORITY_OR_OTHER|||||||0.324|||||||ANCOVA|||Change from Baseline at LOCF (Dorsalis Pedis)||||0.324
72364534|NCT02144610|144241012|SUPERIORITY_OR_OTHER|||||||0.759|||||||ANCOVA|||Change from Baseline at Month 3 (Posterior Tibial)||||0.759
72364535|NCT02144610|144241012|SUPERIORITY_OR_OTHER|||||||0.414|||||||ANCOVA|||Change from Baseline at Month 6 (Posterior Tibial)||||0.414
72364536|NCT02144610|144241012|SUPERIORITY_OR_OTHER|||||||0.886|||||||ANCOVA|||Change from Baseline at Month 9 (Posterior Tibial)||||0.886
72364537|NCT02144610|144241012|SUPERIORITY_OR_OTHER|||||||0.114|||||||ANCOVA|||Change from Baseline at Month 12 (Posterior Tibial)||||0.114
72364538|NCT02144610|144241012|SUPERIORITY_OR_OTHER|||||||0.051|||||||ANCOVA|||Change from Baseline at LOCF (Posterior Tibial)||||0.051
72364539|NCT02144610|144241013|SUPERIORITY_OR_OTHER|||||||0.211|||||||ANCOVA|||Change from Baseline at Month 3||||0.211
72364540|NCT02144610|144241013|SUPERIORITY_OR_OTHER|||||||0.036|||||||ANCOVA|||Change from Baseline at Month 6||||0.036
72364541|NCT02144610|144241013|SUPERIORITY_OR_OTHER|||||||0.725|||||||ANCOVA|||Change from Baseline at Month 9||||0.725
72364542|NCT02144610|144241013|SUPERIORITY_OR_OTHER|||||||0.468|||||||ANCOVA|||Change from Baseline at Month 12||||0.468
72364543|NCT02144610|144241013|SUPERIORITY_OR_OTHER|||||||0.854|||||||ANCOVA|||Change from Baseline at Month 15||||0.854
72364544|NCT02144610|144241013|SUPERIORITY_OR_OTHER|||||||0.233|||||||ANCOVA|||Change from Baseline at LOCF||||0.233
72364545|NCT02144610|144241014|SUPERIORITY_OR_OTHER|||||||0.268|||||||ANCOVA|||Change from Baseline at Month 3||||0.268
72364546|NCT02144610|144241014|SUPERIORITY_OR_OTHER|||||||0.32|||||||ANCOVA|||Change from Baseline at Month 6||||0.320
72364547|NCT02144610|144241014|SUPERIORITY_OR_OTHER|||||||0.315|||||||ANCOVA|||Change from Baseline at Month 9||||0.315
72364548|NCT02144610|144241014|SUPERIORITY_OR_OTHER|||||||0.327|||||||ANCOVA|||Change from Baseline at Month 12||||0.327
72364549|NCT02144610|144241014|SUPERIORITY_OR_OTHER|||||||0.643|||||||ANCOVA|||Change from Baseline at Month 15||||0.643
72364550|NCT02144610|144241014|SUPERIORITY_OR_OTHER|||||||0.74|||||||ANCOVA|||Change from Baseline at LOCF||||0.740
72364551|NCT02144610|144241015|SUPERIORITY_OR_OTHER|||||||0.147|||||||ANCOVA|||Change from Baseline at Month 3||||0.147
72364552|NCT02144610|144241015|SUPERIORITY_OR_OTHER|||||||0.032|||||||ANCOVA|||Change from Baseline at Month 6||||0.032
72364553|NCT02144610|144241015|SUPERIORITY_OR_OTHER|||||||0.709|||||||ANCOVA|||Change from Baseline at Month 9||||0.709
72364554|NCT02144610|144241015|SUPERIORITY_OR_OTHER|||||||0.771|||||||ANCOVA|||Change from Baseline at Month 12||||0.771
72364555|NCT02144610|144241015|SUPERIORITY_OR_OTHER|||||||0.83|||||||ANCOVA|||Change from Baseline at Month 15||||0.830
72364556|NCT02144610|144241015|SUPERIORITY_OR_OTHER|||||||0.033|||||||ANCOVA|||Change from Baseline at LOCF||||0.033
72364557|NCT02144610|144241016|SUPERIORITY_OR_OTHER|||||||0.105|||||||ANCOVA|||Pain (LOCF)||||0.105
72364558|NCT02144610|144241016|SUPERIORITY_OR_OTHER|||||||0.557|||||||ANCOVA|||Symptom (LOCF)||||0.557
72364559|NCT02144610|144241016|SUPERIORITY_OR_OTHER|||||||0.94|||||||ANCOVA|||Activities (LOCF)||||0.940
72364560|NCT02144610|144241016|SUPERIORITY_OR_OTHER|||||||0.905|||||||ANCOVA|||Social (LOCF)||||0.905
72364561|NCT02144610|144241016|SUPERIORITY_OR_OTHER|||||||0.782|||||||ANCOVA|||Emotional Functioning (LOCF)||||0.782
72364562|NCT02144610|144241016|SUPERIORITY_OR_OTHER|||||||0.802|||||||ANCOVA|||Composite Overall (LOCF)||||0.802
72364563|NCT02144610|144241017|SUPERIORITY_OR_OTHER|||||||0.941|||||||ANCOVA|||Change from Baseline at Month 3||||0.941
72364564|NCT02144610|144241017|SUPERIORITY_OR_OTHER|||||||0.584|||||||ANCOVA|||Change from Baseline at Month 6||||0.584
72364565|NCT02144610|144241017|SUPERIORITY_OR_OTHER|||||||0.1|||||||ANCOVA|||Change from Baseline at Month 9||||0.100
72364566|NCT02144610|144241017|SUPERIORITY_OR_OTHER|||||||0.916|||||||ANCOVA|||Change from Baseline at Month 12||||0.916
72364567|NCT02144610|144241017|SUPERIORITY_OR_OTHER|||||||0.486|||||||ANCOVA|||Change from Baseline at Month 15||||0.486
72364568|NCT02144610|144241017|SUPERIORITY_OR_OTHER|||||||0.835|||||||ANCOVA|||Change from Baseline at LOCF||||0.835
72364569|NCT01054885|144241019|SUPERIORITY_OR_OTHER||Least squares mean difference|0.046||||0.085|TWO_SIDED|95.0|-0.006|0.098|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).||||0.098|-0.006|0.085
72364570|NCT01054885|144241019|SUPERIORITY_OR_OTHER||Least squares mean difference|0.041||||0.123|TWO_SIDED|95.0|-0.011|0.093|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).||||0.093|-0.011|0.123
72364571|NCT01054885|144241019|SUPERIORITY_OR_OTHER||Least squares mean difference|0.185|||<|0.001|TWO_SIDED|95.0|0.133|0.237|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).||||0.237|0.133|<0.001
72364572|NCT01054885|144241019|SUPERIORITY_OR_OTHER||Least squares mean difference|0.214|||<|0.001|TWO_SIDED|95.0|0.161|0.266||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).||||0.266|0.161|<0.001
72364573|NCT01054885|144241019|SUPERIORITY_OR_OTHER||Least squares mean difference|0.209|||<|0.001|TWO_SIDED|95.0|0.157|0.261|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).||||0.261|0.157|<0.001
72364574|NCT01054885|144241019|SUPERIORITY_OR_OTHER||Least squares mean difference|0.168|||<|0.001|TWO_SIDED|95.0|0.116|0.22||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).||||0.220|0.116|<0.001
72364575|NCT01054885|144241019|SUPERIORITY_OR_OTHER||Least squares mean difference|0.168|||<|0.001|TWO_SIDED|95.0|0.117|0.219|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).||||0.219|0.117|<0.001
72364576|NCT01054885|144241019|SUPERIORITY_OR_OTHER||Least squares mean difference|0.029||||0.274|TWO_SIDED|95.0|-0.023|0.081|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).||||0.081|-0.023|0.274
72364577|NCT01054885|144241019|SUPERIORITY_OR_OTHER||Least squares mean difference|0.024||||0.357|TWO_SIDED|95.0|-0.027|0.075|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).||||0.075|-0.027|0.357
72364578|NCT01054885|144241020|SUPERIORITY_OR_OTHER||Least squares mean difference|0.044||||0.095|TWO_SIDED|95.0|-0.008|0.097|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).||||0.097|-0.008|0.095
72364579|NCT01054885|144241020|SUPERIORITY_OR_OTHER||Least squares mean difference|0.008||||0.756|TWO_SIDED|95.0|-0.044|0.06|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).||||0.060|-0.044|0.756
72364580|NCT01054885|144241020|SUPERIORITY_OR_OTHER||Least squares mean difference|0.1|||<|0.001|TWO_SIDED|95.0|0.048|0.151|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).||||0.151|0.048|<0.001
72364581|NCT01054885|144241020|SUPERIORITY_OR_OTHER||Least squares mean difference|0.144|||<|0.001|TWO_SIDED|95.0|0.091|0.197||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).||||0.197|0.091|<0.001
72364582|NCT01054885|144241020|SUPERIORITY_OR_OTHER||Least squares mean difference|0.131|||<|0.001|TWO_SIDED|95.0|0.08|0.183|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).||||0.183|0.080|<0.001
72364583|NCT01054885|144241020|SUPERIORITY_OR_OTHER||Least squares mean difference|0.1|||<|0.001|TWO_SIDED|95.0|0.047|0.152||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).||||0.152|0.047|<0.001
72364584|NCT01054885|144241020|SUPERIORITY_OR_OTHER||Least squares mean difference|0.123|||<|0.001|TWO_SIDED|95.0|0.072|0.174||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).||||0.174|0.072|<0.001
72364585|NCT01054885|144241020|SUPERIORITY_OR_OTHER||Least squares mean difference|0.045||||0.093|TWO_SIDED|95.0|-0.008|0.097|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).||||0.097|-0.008|0.093
72364586|NCT01054885|144241020|SUPERIORITY_OR_OTHER||Least squares mean difference|0.032||||0.224|TWO_SIDED|95.0|-0.019|0.083|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).||||0.083|-0.019|0.224
72364587|NCT01399372|144241030|SUPERIORITY||Hazard Ratio (HR)|0.51||||0.015|TWO_SIDED|95.0|0.27|0.95||One-sided significance level = 0.15|Log Rank||Reference arm = Chemotherapy|Sample size of 89 provided 80% power to detect a hazard ratio of 0.63 at a one-sided alpha level of 0.15.||0.95|0.27|0.015
72364588|NCT01399372|144241031|SUPERIORITY||Hazard Ratio (HR)|0.77||||0.48|TWO_SIDED|95.0|0.38|1.58||Two-sided significance level = 0.05|Log Rank||Reference arm = Chemotherapy|||1.58|0.38|0.48
72364589|NCT01399372|144241033|SUPERIORITY|||||||0.005|||||||Mixed Models Analysis|||A mixed effects model of EORTC QLQ-C30 GHS was run with independent variables treatment arm, time, baseline Memorial Sloan-Kettering Cancer Center (MSKCC) recursive partitioning analysis (RPA) class, and baseline neurologic symptoms (none/minor vs. moderate/severe), including the interaction of treatment and time, representing difference in the longitudinal trajectory of the scores between the treatment arms. Prospectively, the interaction effect was of most interest and is reported here,||||0.005
72364590|NCT01399372|144241034|SUPERIORITY||Hazard Ratio (HR)|0.52||||0.18|TWO_SIDED|95.0|0.21|1.31|||Gray's test||Reference arm = Chemotherapy arm|||1.31|0.21|0.18
72364591|NCT01432730|144241036|SUPERIORITY||Log mean difference (Active - Placebo)|-0.6027||||0.0003|TWO_SIDED|95.0|-0.9049|-0.3005|||Mixed Models Analysis|Mixed model included terms for treatment sequence, participant within sequence, treatment \& period. Average \& period baseline covariates included.||||-0.3005|-0.9049|0.0003
72364592|NCT01432730|144241037|SUPERIORITY||Mean Difference (Final Values)|-25.57||||0.003|TWO_SIDED|95.0|-41.53|-9.62|||Mixed Models Analysis|Mixed effect model fitting terms for treatment sequence, participant within sequence, treatment, and period.||||-9.62|-41.53|0.003
72364593|NCT01432730|144241038|SUPERIORITY||Log mean difference (Active - Placebo)|-0.4212||||0.057|TWO_SIDED|95.0|-0.8568|0.01438|||Mixed Models Analysis|Mixed model included terms for treatment sequence, participant within sequence, treatment \& period. Average \& period baseline covariates included.||||0.01438|-0.8568|0.057
72364594|NCT01432730|144241039|SUPERIORITY||Mean Difference (Final Values)|-8.53||||0.172|TWO_SIDED|95.0|-20.93|3.87|||Mixed Models Analysis|Mixed effect model fitting terms for treatment sequence, participant within sequence, treatment, and period.||||3.87|-20.93|0.172
72364595|NCT01432730|144241040|SUPERIORITY||Log mean difference (Active - Placebo)|-0.582||||0.001|TWO_SIDED|95.0|-0.8934|-0.2707|||Mixed Models Analysis|Mixed model included terms for treatment sequence, participant within sequence, treatment \& period. Average \& period baseline covariates included.||||-0.2707|-0.8934|0.001
72364596|NCT01432730|144241041|SUPERIORITY||Mean Difference (Final Values)|-2.538||||0.033|TWO_SIDED|95.0|-4.849|-0.227|||Mixed Models Analysis|Mixed effect model fitting terms for treatment sequence, participant within sequence, treatment, and period.||||-0.227|-4.849|0.033
72364597|NCT01432730|144241042|SUPERIORITY||Median Difference (Final Values)|-2.267||||0.049|TWO_SIDED|95.0|-4.523|-0.01|||Mixed Models Analysis|Mixed effect model fitting terms for treatment sequence, participant within sequence, treatment, and period.||||-0.010|-4.523|0.049
72364598|NCT01432730|144241043|SUPERIORITY||Mean Difference (Final Values)|-9.237||||0.018|TWO_SIDED|95.0|-16.759|-1.716|||Mixed Models Analysis|Mixed effect model fitting terms for treatment sequence, participant within sequence, treatment, and period.||||-1.716|-16.759|0.018
72364599|NCT01432730|144241044|SUPERIORITY||Mean Difference (Final Values)|-21.25||||0.035|TWO_SIDED|95.0|-40.96|-1.54|||Mixed Models Analysis|Mixed effect model fitting terms for treatment sequence, participant within sequence, treatment, and period.||||-1.54|-40.96|0.035
72364600|NCT03881852|144241059|SUPERIORITY||||||<|0.001||||||P-value calculated from LSMean|Mixed Models Analysis|||||||<0.001
72364601|NCT01421719|144241060|SUPERIORITY_OR_OTHER|||||||0.0087||95.0|||||t-test, 2 sided|||Paired t test comparison of baseline number of urinary leaks per day versus number of leaks per day at 6 month evaluation after treatment.||||0.0087
72364602|NCT01298648|144241082|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|Paired t-test using observed cases at Baseline and Week 4.||||||<0.0001
72364603|NCT01298648|144241084|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 1 sided|Paired t-test using observed values at Baseline and Week 8.||||||<0.0001
72364604|NCT01298648|144241085|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|Paired t-test using observed values at Baseline and Week 24.||||||<0.0001
72364605|NCT04226742|144241136|SUPERIORITY||Mean Difference (Net)|0.58||||0.79|TWO_SIDED|95.0|-3.71|4.88||The threshold for statistical significance was p = 0.05|Mixed Models Analysis|||||4.88|-3.71|0.79
72364606|NCT04226742|144241137|SUPERIORITY||Mean Difference (Net)|0.9||||0.61|TWO_SIDED|95.0|-2.52|4.32||The threshold for statistical significance was p = 0.05|Mixed Models Analysis|||||4.32|-2.52|.61
72364607|NCT04226742|144241138|SUPERIORITY||Mean Difference (Final Values)|0.32||||0.088|TWO_SIDED|95.0|-0.05|0.68||Significance threshold of alpha = 0.05|Mixed Models Analysis|||||0.68|-0.05|0.088
72364608|NCT04226742|144241139|SUPERIORITY||Mean Difference (Final Values)|13.68||||0.142|TWO_SIDED|95.0|-4.62|31.99||Threshold for statistical significance of alpha = 0.05|Mixed Models Analysis|||||31.99|-4.62|0.142
72364609|NCT04226742|144241140|SUPERIORITY||Mean Difference (Final Values)|-6.87||||0.109|TWO_SIDED|95.0|-15.28|1.54||Threshold for statistical significance of alpha = .05|Mixed Models Analysis|||||1.54|-15.28|0.109
72364610|NCT04226742|144241141|SUPERIORITY||Mean Difference (Final Values)|-1.01||||0.736|TWO_SIDED|95.0|-6.92|4.89|||Mixed Models Analysis|||||4.89|-6.92|0.736
72364611|NCT02606643|144241147|SUPERIORITY_OR_OTHER|||||||0.814|||||||Chi-squared|||an alpha level of .05, and a level of power of 80%. These parameters required a sample size of 63 patients per group||||0.814
72364612|NCT03418714|144241151|SUPERIORITY|||||||0.006|||||||t-test, 2 sided|||T test on the change in network activity across all networks, from before to after salvinorin A administration.||||.006
72364613|NCT03418714|144241152|SUPERIORITY|||||||0.001|||||||t-test, 2 sided|||T test on the change in within- and between-network connectivity across all values, from before to after salvinorin A administration.||||.001
72364614|NCT03879772|144241168|SUPERIORITY|||||||0.95|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way analysis of variance (ANOVA).||||0.95
72364615|NCT03879772|144241168|SUPERIORITY|||||||0.78|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||0.78
72364616|NCT03879772|144241168|SUPERIORITY|||||||0.98|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||0.98
72364617|NCT03879772|144241168|SUPERIORITY|||||||0.01|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||0.01
72364618|NCT03879772|144241168|SUPERIORITY|||||||0.82|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||0.82
72364619|NCT03879772|144241168|SUPERIORITY|||||||0.98|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||0.98
72364620|NCT03879772|144241168|SUPERIORITY|||||||0.01|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||0.01
72364621|NCT03879772|144241168|SUPERIORITY|||||||0.8|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||0.8
72364622|NCT03879772|144241168|SUPERIORITY|||||||0.02|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||0.02
72364623|NCT03879772|144241168|SUPERIORITY|||||||0.01|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||0.01
72364624|NCT03879772|144241169|SUPERIORITY|||||||0.56|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||0.56
72364625|NCT03879772|144241169|SUPERIORITY|||||||0.74|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||0.74
72364626|NCT03879772|144241169|SUPERIORITY|||||||0.68|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||0.68
72364627|NCT03879772|144241169|SUPERIORITY||||||<|0.01|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||<0.01
72364628|NCT03879772|144241169|SUPERIORITY|||||||0.81|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||0.81
72364629|NCT03879772|144241169|SUPERIORITY|||||||0.33|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||0.33
72364630|NCT03879772|144241169|SUPERIORITY|||||||0.01|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||0.01
72364631|NCT03879772|144241169|SUPERIORITY|||||||0.46|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||0.46
72364632|NCT03879772|144241169|SUPERIORITY||||||<|0.01|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||<0.01
72364633|NCT03879772|144241169|SUPERIORITY||||||<|0.01|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||<0.01
72364634|NCT03879772|144241170|SUPERIORITY|||||||0.8|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||0.8
72364635|NCT03879772|144241170|SUPERIORITY|||||||0.45|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||0.45
72364636|NCT03879772|144241170|SUPERIORITY|||||||0.12|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||0.12
72364637|NCT03879772|144241170|SUPERIORITY|||||||0.36|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||0.36
72364638|NCT03879772|144241170|SUPERIORITY|||||||0.6|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||0.6
72364639|NCT03879772|144241170|SUPERIORITY|||||||0.17|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||0.17
72364640|NCT03879772|144241170|SUPERIORITY|||||||0.23|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||0.23
72364641|NCT03879772|144241170|SUPERIORITY|||||||0.42|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||0.42
72364642|NCT03879772|144241170|SUPERIORITY|||||||0.09|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||0.09
72364643|NCT03879772|144241170|SUPERIORITY|||||||0.01|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||0.01
72364644|NCT03879772|144241171|SUPERIORITY|||||||0.03|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||0.03
72364645|NCT03879772|144241171|SUPERIORITY|||||||0.04|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||0.04
72364646|NCT03879772|144241171|SUPERIORITY|||||||0.08|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||0.08
72364647|NCT03879772|144241171|SUPERIORITY|||||||0.49|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||0.49
72364648|NCT03879772|144241171|SUPERIORITY|||||||0.93|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||0.93
72364649|NCT03879772|144241171|SUPERIORITY|||||||0.75|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||0.75
72364650|NCT03879772|144241171|SUPERIORITY||||||<|0.01|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||<0.01
72364651|NCT03879772|144241171|SUPERIORITY|||||||0.71|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||0.71
72364652|NCT03879772|144241171|SUPERIORITY||||||<|0.01|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||<0.01
72364653|NCT03879772|144241171|SUPERIORITY|||||||0.01|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||0.01
72364654|NCT03879772|144241172|SUPERIORITY|||||||0.16|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||0.16
72364655|NCT03879772|144241172|SUPERIORITY|||||||0.22|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||0.22
72364656|NCT03879772|144241172|SUPERIORITY|||||||0.14|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||0.14
72364657|NCT03879772|144241172|SUPERIORITY|||||||0.14|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||0.14
72364658|NCT03879772|144241172|SUPERIORITY|||||||0.85|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||0.85
72364659|NCT03879772|144241172|SUPERIORITY|||||||0.96|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||0.96
72364660|NCT03879772|144241172|SUPERIORITY||||||<|0.01|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||<0.01
72364661|NCT03879772|144241172|SUPERIORITY|||||||0.81|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||0.81
72364662|NCT03879772|144241172|SUPERIORITY||||||<|0.01|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||<0.01
72364663|NCT03879772|144241172|SUPERIORITY||||||<|0.01|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||<0.01
72364664|NCT03879772|144241173|SUPERIORITY|||||||0.05|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||0.05
72364665|NCT03879772|144241173|SUPERIORITY|||||||0.07|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||0.07
72364666|NCT03879772|144241173|SUPERIORITY|||||||0.11|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||0.11
72364667|NCT03879772|144241173|SUPERIORITY|||||||0.31|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||0.31
72364668|NCT03879772|144241173|SUPERIORITY|||||||0.94|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||0.94
72364669|NCT03879772|144241173|SUPERIORITY|||||||0.73|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||0.73
72364670|NCT03879772|144241173|SUPERIORITY||||||<|0.01|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||<0.01
72364671|NCT03879772|144241173|SUPERIORITY|||||||0.79|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||0.79
72364672|NCT03879772|144241173|SUPERIORITY||||||<|0.01|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||<0.01
72364673|NCT03879772|144241173|SUPERIORITY||||||<|0.01|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||<0.01
72364674|NCT00728689|144241188|SUPERIORITY_OR_OTHER|||||||0.4591|||||||ANOVA|||A sample size of 12 subjects was chosen to provide a statistical power of 80% to detect a 25% difference of the Form V mean between the Form I and Form V doses at the 0.05 level (2-sided) for this crossover design. A parametric (normal theory) general linear model was applied and an ANOVA for a 2-way crossover design was employed to examine the differences among the 2 forms.||||0.4591
72364675|NCT00728689|144241189|SUPERIORITY_OR_OTHER|||||||0.0048|||||||ANOVA|||A sample size of 12 subjects was chosen to provide a statistical power of 80% to detect a 25% difference of the Form V mean between the Form I and Form V doses at the 0.05 level (2-sided) for this crossover design. Firstly, a parametric (normal theory) general linear model was applied and an ANOVA for a 2-way crossover design was employed to examine the differences among the 2 forms. Secondly, AUC0-τ was analyzed on a log scale, to assess bioequivalence between Form I and Form V.||||0.0048
72364676|NCT00728689|144241190|SUPERIORITY_OR_OTHER|||||||0.0997|||||||ANOVA|||A sample size of 12 subjects was chosen to provide a statistical power of 80% to detect a 25% difference of the Form V mean between the Form I and Form V doses at the 0.05 level (2-sided) for this crossover design. Firstly, a parametric (normal theory) general linear model was applied and an ANOVA for a 2-way crossover design was employed to examine the differences among the 2 forms. Secondly, AUC0-∞ was analyzed on a log scale, to assess bioequivalence between Form I and Form V.||||0.0997
72364677|NCT00728689|144241191|SUPERIORITY_OR_OTHER|||||||0.0422|||||||ANOVA|||A sample size of 12 subjects was chosen to provide a statistical power of 80% to detect a 25% difference of the Form V mean between the Form I and Form V doses at the 0.05 level (2-sided) for this crossover design. Firstly, a parametric (normal theory) general linear model was applied and an ANOVA for a 2-way crossover design was employed to examine the differences among the 2 forms. Secondly, Cmax was analyzed on a log scale, to assess bioequivalence between Form I and Form V.||||0.0422
72364678|NCT00728689|144241192|SUPERIORITY_OR_OTHER|||||||0.8581|||||||ANOVA|||A sample size of 12 subjects was chosen to provide a statistical power of 80% to detect a 25% difference of the Form V mean between the Form I and Form V doses at the 0.05 level (2-sided) for this crossover design. A parametric (normal theory) general linear model was applied and an ANOVA for a 2-way crossover design was employed to examine the differences among the 2 forms.||||0.8581
72364679|NCT01867671|144241193|SUPERIORITY||Odds Ratio (OR)|205.45|||<|0.0001|TWO_SIDED|95.0|24.0|1758.51|||Regression, Logistic|||||1758.51|24.00|<0.0001
72364680|NCT01867671|144241194|SUPERIORITY||Odds Ratio (OR)|27.82|||<|0.0031|TWO_SIDED|95.0|3.07|252.33|||Regression, Logistic|||||252.33|3.07|<0.0031
72364681|NCT01867671|144241195|OTHER|McNemar's Test|Simple Kappa Coefficient|0.162|||<|0.0001|TWO_SIDED|95.0|0.0628|0.2612|||McNemar|||||0.2612|0.0628|<0.0001
72364682|NCT01867671|144241196|SUPERIORITY||Mean Difference (Final Values)|1464.0|||<|0.0001|TWO_SIDED|95.0|944.0|1985.0|||Chi-squared|||||1985|944|<0.0001
72364683|NCT01523366|144241198|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-167.2|STANDARD_ERROR_OF_MEAN|14.6|<|0.001|TWO_SIDED|95.0|-197.0|-137.4|||Mixed Models Analysis|Model contained treatment group, period, and sequence as fixed effects, and a random effect for participant within sequence|Ticagrelor minus clopidogrel|||-137.4|-197.0|<.001
72364684|NCT01523366|144241199|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-135.2|STANDARD_ERROR_OF_MEAN|18.23|<|0.001|TWO_SIDED|95.0|-172.3|-98.0|||Mixed Models Analysis|Model contained treatment group, period, and sequence as fixed effects, and a random effect for participant within sequence|Ticagrelor minus Clopidogrel|Analysis at 0.5 hours after the loading dose||-98.0|-172.3|<.001
72364685|NCT01523366|144241199|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-168.9|STANDARD_ERROR_OF_MEAN|17.28|<|0.001|TWO_SIDED|95.0|-204.0|-133.7|||Mixed Models Analysis|Model contained treatment group, period, and sequence as fixed effects, and a random effect for participant within sequence|Ticagrelor minus Clopidogrel|Analysis at 8 hours after the loading dose||-133.7|-204.0|<.001
72364686|NCT01523366|144241200|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-150.5|STANDARD_ERROR_OF_MEAN|12.97|<|0.001|TWO_SIDED|95.0|-176.9|-124.1|||Mixed Models Analysis|Model contained treatment group, period, and sequence as fixed effects, and a random effect for participant within sequence|Ticagrelor minus Clopidogrel|Analysis at 2 hours on Day 7 after multiple doses||-124.1|-176.9|<.001
72364687|NCT01523366|144241200|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-140.2|STANDARD_ERROR_OF_MEAN|13.84|<|0.001|TWO_SIDED|95.0|-168.4|-111.9|||Mixed Models Analysis|Model contained treatment group, period, and sequence as fixed effects, and a random effect for participant within sequence|Ticagrelor minus clopidogrel.|Analysis at 8 hours on Day 7 after multiple doses||-111.9|-168.4|<.001
72364688|NCT01523366|144241200|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-130.6|STANDARD_ERROR_OF_MEAN|13.41|<|0.001|TWO_SIDED|95.0|-158.0|-103.2|||Mixed Models Analysis|Model contained treatment group, period, and sequence as fixed effects, and a random effect for participant within sequence|Ticagrelor minus clopidogrel.|Analysis at end of dosing interval on Day 8||-103.2|-158.0|<.001
72364689|NCT00929695|144241237|SUPERIORITY_OR_OTHER|||||||0.08|TWO_SIDED||||||t-test, 2 sided|||||||0.08
72364690|NCT00929695|144241237|SUPERIORITY_OR_OTHER|||||||0.4|TWO_SIDED||||||t-test, 2 sided|||||||0.4
72364691|NCT00929695|144241245|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.43|||||TWO_SIDED|95.0|0.14|1.33||||||||1.33|0.14|
72364692|NCT00929695|144241246|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.29||||0.009|TWO_SIDED|95.0|0.12|0.74|||Regression, Cox|||||0.74|0.12|0.009
72364693|NCT00929695|144241248|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.02||||0.95|TWO_SIDED|95.0|0.6|1.74|||Regression, Cox|||||1.74|0.6|0.95
72364694|NCT01352715|144241265|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Confidence interval estimation was stratified by randomization stratification factors using Greenwood's variance with the inverse of this variance used for the stratum weights. The pre-specified upper confidence bound for non-inferiority was 10 percentage points.|Cumulative probability difference|-3.4|||||TWO_SIDED|95.0|-8.4|1.5||||||Treatment comparison was made using the difference (arm A - arm B) in the stratified Kaplan-Meier estimate for the week 48 cumulative probability of virologic failure with 95% confidence interval.||1.5|-8.4|
72364695|NCT00871975|144241274|SUPERIORITY_OR_OTHER||Sensitivity (percent)|80.6|||||TWO_SIDED||||||||We found an 80.6% sensitivity for detection of detrusor overactivity on Tetra-NIRS as compared to urodynamics.|A contingency table was used to compare presence or absence of an event (eg. detrusor overactivity) on the urodynamic tracing with interpretation of events on the Tetra-NIRS tracings.||||
72364696|NCT00871975|144241274|SUPERIORITY_OR_OTHER||Specificity (percent)|28.1|||||TWO_SIDED||||||||We found a 28.1% specificity for detection of detrusor overactivity on Tetra-NIRS as compared to urodynamics.|A contingency table was used to compare presence or absence of an event (eg. detrusor overactivity) on the urodynamic tracing with interpretation of events on the Tetra-NIRS tracings.||||
72364697|NCT03755934|144241288|SUPERIORITY||LS mean estimate|-1.96|STANDARD_ERROR_OF_MEAN|0.961||0.0437|TWO_SIDED|95.0|-3.87|-0.06||ANCOVA by dose using NRS baseline value and co-medication as covariates, with CFB to Week 12 (LOCF) as dependent variable was used to derive p-value.|ANCOVA|||||-0.06|-3.87|0.0437
72364698|NCT03755934|144241288|SUPERIORITY||LS mean estimate|0.72|STANDARD_ERROR_OF_MEAN|0.541||0.1878|TWO_SIDED|95.0|-0.36|1.79||ANCOVA by dose using NRS baseline value and co-medication as covariates, with CFB to Week 12 (LOCF) as dependent variable was used to derive p-value.|ANCOVA|||||1.79|-0.36|0.1878
72364699|NCT03755934|144241288|SUPERIORITY||LS mean estimate|-1.39|STANDARD_ERROR_OF_MEAN|0.407||0.0009|TWO_SIDED|95.0|-2.19|-0.58||ANCOVA by dose using NRS baseline value and co-medication as covariates, with CFB to Week 12 (LOCF) as dependent variable was used to derive p-value.|ANCOVA|||||-0.58|-2.19|0.0009
72364700|NCT00817843|144241314|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.09|STANDARD_ERROR_OF_MEAN|0.295||0.766||95.0|||||ANOVA|||"Between treatment difference in the change in FMD from the fasting to the post-fat load state.~Null hypothesis was that combination therapy (simvastatin/ezetimibe) would protect the FMD in the post-fat load phase and would therefore be associated with a smaller drop in FMD~Power calculation was based on the results from a pilot study. To detect a 1.0% difference between treatments with a SD of 2.7% and a power of 90% (alfa 0.05, two tailed) 80 evaluable patients were needed."||||0.766
72364701|NCT00307801|144241315|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||inverting 2 one-sided tests|||||||< 0.0001
72364702|NCT03431259|144241369|SUPERIORITY|||||||0.0574|||||||Chi-squared|||||||.0574
72364703|NCT03431259|144241369|SUPERIORITY|||||||0.57|||||||Chi-squared|||||||0.570
72364704|NCT00551642|144241371|OTHER||Odds Ratio (OR)|1.05||||0.734|TWO_SIDED||||||Wald Chi-square|||||||0.7340
72364705|NCT03994081|144241392|SUPERIORITY|||||||0.332|||||||t-test, 2 sided|||||||0.332
72364706|NCT03994081|144241393|SUPERIORITY|||||||0.79|||||||t-test, 2 sided|||||||0.790
72364707|NCT03994081|144241394|SUPERIORITY|||||||0.464|||||||Pearson's correlation|||||||0.464
72364708|NCT03994081|144241394|SUPERIORITY|||||||0.765|||||||Pearson's correlation|||||||0.765
72364709|NCT03994081|144241395|SUPERIORITY|||||||0.072|||||||Pearson's correlation|||||||0.072
72364710|NCT03994081|144241395|SUPERIORITY|||||||0.811|||||||Pearson's correlation|||||||0.811
72364711|NCT03955146|144241410|OTHER||LS Mean Difference|0.07|STANDARD_ERROR_OF_MEAN|0.062||0.2926|TWO_SIDED|95.0|-0.06|0.19|||Mixed Models Analysis|||||0.19|-0.06|0.2926
72364712|NCT02628873|144241426|EQUIVALENCE|Degree of agreement between the 2 Assessors|Degree of agreement / Kappa|0.48|||<|0.01|TWO_SIDED||||||Kappa|||||||< 0.01
72364713|NCT02628873|144241427|SUPERIORITY|T-test to determine whether one method had greater reported pain|Mean Difference (Final Values)|-0.925|STANDARD_DEVIATION|2.71|<|0.3|TWO_SIDED|95.0|-2.69|1.0|||t-test, 2 sided|||||1.00|-2.69|< 0.30
72364714|NCT02628873|144241428|SUPERIORITY||Mean Difference (Final Values)|-0.431|STANDARD_DEVIATION|2.76|<|0.67|TWO_SIDED|95.0|-2.4|1.56|||t-test, 2 sided|Paired t-test (pre-procedure versus post-procedure)||||1.56|-2.40|< 0.67
72364715|NCT00905164|144241469|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of the LS mean (test/ref x 100)|99.5|||||TWO_SIDED|90.0|94.27|105.03|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125|||105.03|94.27|
72364716|NCT00905164|144241470|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of the LS mean (test/ref x 100)|100.13||||||90.0|97.6|102.72|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||102.72|97.60|
72364717|NCT00905164|144241471|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of the LS Mean (test/ref x 100)|101.53||||||90.0|99.01|104.12|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||104.12|99.01|
72364718|NCT05366738|144241478|EQUIVALENCE|Bioequivalence was concluded if the 90% confidence interval for the geometric mean ratio between the test treatments (20 mg sprinkle capsule, either sprinkled on pudding or on applesauce) and the reference treatment (20 mg tablet) were wholly contained within 80.00% and 125.00% for the vonoprazan PK parameters.|Ratio of Geometric Least Square Means|103.36|||||TWO_SIDED|90.0|97.64|109.41||||||||109.41|97.64|
72364719|NCT05366738|144241478|EQUIVALENCE|Bioequivalence was concluded if the 90% confidence interval for the geometric mean ratio between the test treatments (20 mg sprinkle capsule, either sprinkled on pudding or on applesauce) and the reference treatment (20 mg tablet) were wholly contained within 80.00% and 125.00% for the vonoprazan PK parameters.|Ratio of Geometric Least Square Means|97.83|||||TWO_SIDED|90.0|92.42|103.56||||||||103.56|92.42|
72364720|NCT05366738|144241479|EQUIVALENCE|Bioequivalence was concluded if the 90% confidence interval for the geometric mean ratio between the test treatments (20 mg sprinkle capsule, either sprinkled on pudding or on applesauce) and the reference treatment (20 mg tablet) were wholly contained within 80.00% and 125.00% for the vonoprazan PK parameters.|Ratio of Geometric Least Square Means|102.56|||||TWO_SIDED|90.0|97.25|108.15||||||||108.15|97.25|
72364721|NCT05366738|144241479|EQUIVALENCE|Bioequivalence was concluded if the 90% confidence interval for the geometric mean ratio between the test treatments (20 mg sprinkle capsule, either sprinkled on pudding or on applesauce) and the reference treatment (20 mg tablet) were wholly contained within 80.00% and 125.00% for the vonoprazan PK parameters.|Ratio of Geometric Least Square Means|97.61|||||TWO_SIDED|90.0|92.55|102.93||||||||102.93|92.55|
72364722|NCT05366738|144241480|EQUIVALENCE|Bioequivalence was concluded if the 90% confidence interval for the geometric mean ratio between the test treatments (20 mg sprinkle capsule, either sprinkled on pudding or on applesauce) and the reference treatment (20 mg tablet) were wholly contained within 80.00% and 125.00% for the vonoprazan PK parameters.|Ratio of Geometric Least Square Means|103.96|||||TWO_SIDED|90.0|96.49|112.0||||||||112.00|96.49|
72364723|NCT05366738|144241480|EQUIVALENCE|Bioequivalence was concluded if the 90% confidence interval for the geometric mean ratio between the test treatments (20 mg sprinkle capsule, either sprinkled on pudding or on applesauce) and the reference treatment (20 mg tablet) were wholly contained within 80.00% and 125.00% for the vonoprazan PK parameters.|Ratio of Geometric Least Square Means|100.6|||||TWO_SIDED|90.0|93.38|108.39||||||||108.39|93.38|
72364724|NCT02230995|144241486|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based on 2-sided 90% confidence intervals (CIs) for the ratios (test to reference treatment) of the adjusted geometric means (gMeans) of the primary endpoints, using an acceptance range of 80.00 to 125.00%.|Adjusted gMean ratio|98.22|STANDARD_DEVIATION|5.0|<|1e-05|TWO_SIDED|90.0|96.11|100.39|||ANOVA|ANOVA model on the logarithmic scale including random effects for 'subjects within sequences' \& fixed effect for 'sequence', 'period' \& 'treatment'.|Relative bioavailability of empagliflozin was estimated by the ratios of the adjusted gMean of Fed 25mg+1000mg FDC divided by Fed 25mg+1000mg Single. Standard deviation is actually Intra individual geometric coefficient variation (gCV).|||100.39|96.11|<0.00001
72364725|NCT02230995|144241487|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based on 2-sided 90% confidence intervals (CIs) for the ratios (test to reference treatment) of the adjusted geometric means (gMeans) of the primary endpoints, using an acceptance range of 80.00 to 125.00%.|Adjusted gMean ratio|102.14|STANDARD_DEVIATION|7.9|<|1e-05|TWO_SIDED|90.0|98.65|105.76|||ANOVA|ANOVA model on the logarithmic scale including random effects for 'subjects within sequences' \& fixed effect for 'sequence', 'period' \& 'treatment'.|Relative bioavailability of metformin was estimated by the ratios of the adjusted gMean of Fed 25mg+1000mg FDC divided by Fed 25mg+1000mg Single. Standard deviation is actually Intra individual geometric coefficient variation (gCV).|||105.76|98.65|<0.00001
72364726|NCT02230995|144241488|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based on 2-sided 90% confidence intervals (CIs) for the ratios (test to reference treatment) of the adjusted geometric means (gMeans) of the primary endpoints, using an acceptance range of 80.00 to 125.00%.|Adjusted gMean ratio|98.7|STANDARD_DEVIATION|12.3|<|1e-05|TWO_SIDED|90.0|93.51|104.17|||ANOVA|ANOVA model on the logarithmic scale including random effects for 'subjects within sequences' \& fixed effect for 'sequence', 'period' \& 'treatment'.|Relative bioavailability of empagliflozin was estimated by the ratios of the adjusted gMean of Fed 25mg+1000mg FDC divided by Fed 25mg+1000mg Single. Standard deviation is actually Intra individual geometric coefficient variation (gCV).|||104.17|93.51|<0.00001
72364727|NCT02230995|144241489|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based on 2-sided 90% confidence intervals (CIs) for the ratios (test to reference treatment) of the adjusted geometric means (gMeans) of the primary endpoints, using an acceptance range of 80.00 to 125.00%.|Adjusted gMean ratio|105.69|STANDARD_DEVIATION|10.9|<|1e-05|TWO_SIDED|90.0|100.78|110.84|||ANOVA|ANOVA model on the logarithmic scale including random effects for 'subjects within sequences' \& fixed effect for 'sequence', 'period' \& 'treatment'.|Relative bioavailability of metformin was estimated by the ratios of the adjusted gMean of Fed 25mg+1000mg FDC divided by Fed 25mg+1000mg Single. Standard deviation is actually Intra individual geometric coefficient variation (gCV).|||110.84|100.78|<0.00001
72364728|NCT02230995|144241490|SUPERIORITY_OR_OTHER||Adjusted gMean ratio|98.32|STANDARD_DEVIATION|5.1|||TWO_SIDED|90.0|96.16|100.53|||ANOVA|ANOVA model on the logarithmic scale including random effects for 'subjects within sequences' \& fixed effect for 'sequence', 'period' \& 'treatment'.|Relative bioavailability of empagliflozin was estimated by ratios of adjusted geometric means (gMean) of Fed 25mg+1000mg FDC divided by Fed 25mg+1000mg Single. Standard deviation is actually Intra individual geometric coefficient variation (gCV).|||100.53|96.16|
72364729|NCT02230995|144241491|SUPERIORITY_OR_OTHER||Adjusted gMean ratio|104.66|STANDARD_DEVIATION|7.3|||TWO_SIDED|90.0|101.36|108.07|||ANOVA|ANOVA model on the logarithmic scale including random effects for 'subjects within sequences' \& fixed effect for 'sequence', 'period' \& 'treatment'.|Relative bioavailability of metformin was estimated by the ratios of the adjusted geometric means (gMean) of Fed 25mg+1000mg FDC divided by Fed 25mg+1000mg Single. Standard deviation is actually Intra individual geometric coefficient variation (gCV).|||108.07|101.36|
72364730|NCT00906204|144241492|NON_INFERIORITY_OR_EQUIVALENCE|A one-sided alpha = 0.05, 85% power, an event rate of 0.70, equivalence margin of 0.20. Sample size = 75 patients per dose group, a total of 150 patients. Data analyzed will be counts of patients in each group who experience one or more component events of the primary endpoint during postoperative days one through seven. The DSMB requested an interim analysis after 80 patients and recommended ending the trial because the primary endpoint had been robustly reached.||||||0.64|TWO_SIDED||||||Fisher Exact|||The analysis compares the rates at which patients in each of the two groups cumulatively exceed the five composite endpoint thresholds. There are five safety outcomes monitored during the first seven post-transplantation days. The rates of observed vs. possible safety outcomes are compared.||||0.64
72364731|NCT00906204|144241493|SUPERIORITY_OR_OTHER|||||||0.35|TWO_SIDED||||||Log Rank|||||||0.35
72364732|NCT00906204|144241494|SUPERIORITY_OR_OTHER|||||||0.47|TWO_SIDED||||||Log Rank|||||||0.47
72364733|NCT00906204|144241495|SUPERIORITY_OR_OTHER|||||||0.78|TWO_SIDED||||||Log Rank|||||||0.78
72364734|NCT00906204|144241496|SUPERIORITY_OR_OTHER|||||||0.72|TWO_SIDED||||||Fisher Exact|||||||0.72
72364735|NCT00906204|144241497|SUPERIORITY_OR_OTHER|||||||0.85|TWO_SIDED||||||t-test, 2 sided|||||||0.85
72364736|NCT01389596|144241503|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.092||0.2577|TWO_SIDED|95.0|-0.29|0.08|||ANCOVA|||Linear Model With Log transformed baseline seizure rate as continuous covariate and geographic regions, treatment groups and weight as fixed effects.||0.08|-0.29|0.2577
72364737|NCT01389596|144241503|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.094||0.0185|TWO_SIDED|95.0|-0.41|-0.04|||ANCOVA|||Linear Model With Log transformed baseline seizure rate as continuous covariate and geographic regions, treatment groups and weight as fixed effects.||-0.04|-0.41|0.0185
72364738|NCT01389596|144241504|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.036||||0.8024|TWO_SIDED|95.0|0.528|2.03|||Regression, Logistic|||P-values were from a Logistic Regression Model including fixed effects for treatment, weight group, and geographical region.||2.030|0.528|0.8024
72364739|NCT01389596|144241504|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.636||||0.0092|TWO_SIDED|95.0|0.851|3.147|||Regression, Logistic|||P-values were from a Logistic Regression Model including fixed effects for treatment, weight group, and geographical region.||3.147|0.851|0.0092
72364740|NCT00565084|144241529|SUPERIORITY_OR_OTHER||Difference in LS Means|0.06||||0.743||90.0|-0.23|0.35|||ANOVA|||Primary efficacy endpoint was assessed by an ANOVA model with terms for treatment, period, sequence, and patients within sequence. Efficacy advantage over placebo was assessed via the treatment difference in the least-squares (LS) means (ibuprofen vs. average of the 2 placebo treatments) from the ANOVA model and the 90% confidence interval (CI; one-sided alpha=0.05) of the LS mean difference will be assessed.||0.35|-0.23|0.743
72364741|NCT03038100|144241559|SUPERIORITY||Hazard Ratio (HR)|0.92||||0.2785|TWO_SIDED|95.0|0.79|1.07|||Log Rank|||||1.07|0.79|0.2785
72364742|NCT03038100|144241560|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.8||||0.0376|TWO_SIDED|95.0|0.65|0.99|||Log Rank|||||0.99|0.65|0.0376
72364743|NCT03038100|144241561|SUPERIORITY||Hazard Ratio (HR)|0.92||||0.3432|TWO_SIDED|95.0|0.78|1.09|||Log Rank|||Stratified by: stage and/or surgical status (Stage III vs. Stage IV), ECOG performance status (0 vs. 1 or 2), tumor PD-L1 status (IC0 vs. IC1/2/3), and treatment strategy (adjuvant vs. neoadjuvant).||1.09|0.78|0.3432
72364744|NCT03038100|144241562|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.83||||0.1316|TWO_SIDED|95.0|0.66|1.06|||Log Rank|||Stratified by: stage and/or surgical status (Stage III vs. Stage IV), ECOG performance status (0 vs. 1 or 2) and treatment strategy (adjuvant vs. neoadjuvant).||1.06|0.66|0.1316
72364745|NCT03038100|144241568|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.97||||0.9096|TWO_SIDED|95.0|0.58|1.62|||Cochran-Mantel-Haenszel|||Emotional Functioning, Presurgical/Surgery||1.62|0.58|0.9096
72364746|NCT03038100|144241568|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.21||||0.4662|TWO_SIDED|95.0|0.73|2.01|||Cochran-Mantel-Haenszel|||Emotional functioning, Cycle 4 Day 1||2.01|0.73|0.4662
72364747|NCT03038100|144241568|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.85||||0.5237|TWO_SIDED|95.0|0.51|1.4|||Cochran-Mantel-Haenszel|||Emotional functioning, Cycle 6 Day 1||1.40|0.51|0.5237
72364748|NCT03038100|144241568|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.25||||0.3826|TWO_SIDED|95.0|0.76|2.07|||Cochran-Mantel-Haenszel|||Emotional functioning, Cycle 8 Day 1||2.07|0.76|0.3826
72364749|NCT03038100|144241568|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.0||||0.9893|TWO_SIDED|95.0|0.56|1.76|||Cochran-Mantel-Haenszel|||Emotional Functioning, Cycle 12 Day 1||1.76|0.56|0.9893
72364750|NCT03038100|144241568|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.89||||0.6892|TWO_SIDED|95.0|0.49|1.61|||Cochran-Mantel-Haenszel|||Emotional Functioning, Cycle 16 Day 1||1.61|0.49|0.6892
72364751|NCT03038100|144241568|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.59||||0.1324|TWO_SIDED|95.0|0.3|1.17|||Cochran-Mantel-Haenszel|||Emotional Functioning, Cycle 20 Day 1||1.17|0.30|0.1324
72364752|NCT03038100|144241568|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.03||||0.9176|TWO_SIDED|95.0|0.62|1.7|||Cochran-Mantel-Haenszel|||Emotional Functioning, Completion of Treatment/Early Termination Visit||1.70|0.62|0.9176
72364753|NCT03038100|144241568|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.92||||0.7861|TWO_SIDED|95.0|0.5|1.68|||Cochran-Mantel-Haenszel|||Emotional Functioning, Post-Treatment Follow Up 3 Months||1.68|0.50|0.7861
72364754|NCT03038100|144241568|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.31||||0.4539|TWO_SIDED|95.0|0.65|2.65|||Cochran-Mantel-Haenszel|||Emotional Functioning, Post-Treatment Follow Up 6 Months||2.65|0.65|0.4539
72364755|NCT03038100|144241568|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.71||||0.4849|TWO_SIDED|95.0|0.27|1.86|||Cochran-Mantel-Haenszel|||Emotional Functioning, Post-Treatment Follow Up 9 Months||1.86|0.27|0.4849
72364756|NCT03038100|144241568|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.79||||0.747|TWO_SIDED|95.0|0.19|3.34|||Cochran-Mantel-Haenszel|||Emotional Functioning, Post-Treatment Follow Up 12 Months||3.34|0.19|0.7470
72364757|NCT03038100|144241568|SUPERIORITY|Stratified Analysis|Difference in Proportion of Responders|33.33||||0.0896|TWO_SIDED|95.0|-44.86|100.0|||Cochran-Mantel-Haenszel|||Emotional Functioning, Post-Treatment Follow Up 18 Months||100.00|-44.86|0.0896
72364758|NCT03038100|144241568|SUPERIORITY|Stratified Analysis|Difference in Proportion of Responders|50.0|||||TWO_SIDED|95.0|-94.3|100.0||||||Emotional Functioning, Post-Treatment Follow Up 24 Months||100.00|-94.30|
72364759|NCT03038100|144241568|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.92||||0.7347|TWO_SIDED|95.0|0.56|1.5|||Cochran-Mantel-Haenszel|||Physical Functioning, Presurgical/Surgery||1.50|0.56|0.7347
72364760|NCT03038100|144241568|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.56||||0.0479|TWO_SIDED|95.0|0.32|1.0|||Cochran-Mantel-Haenszel|||Physical Functioning, Cycle 4 Day 1||1.00|0.32|0.0479
72364761|NCT03038100|144241568|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.61||||0.0712|TWO_SIDED|95.0|0.36|1.05|||Cochran-Mantel-Haenszel|||Physical Functioning, Cycle 6 Day 1||1.05|0.36|0.0712
72364762|NCT03038100|144241568|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.94||||0.8168|TWO_SIDED|95.0|0.56|1.58|||Cochran-Mantel-Haenszel|||Physical Functioning, Cycle 8 Day 1||1.58|0.56|0.8168
72364763|NCT03038100|144241568|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.88||||0.6417|TWO_SIDED|95.0|0.5|1.52|||Cochran-Mantel-Haenszel|||Physical Functioning, Cycle 12 Day 1||1.52|0.50|0.6417
72364764|NCT03038100|144241568|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.96||||0.8821|TWO_SIDED|95.0|0.53|1.72|||Cochran-Mantel-Haenszel|||Physical Functioning, Cycle 16 Day 1||1.72|0.53|0.8821
72364765|NCT03038100|144241568|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.64||||0.2158|TWO_SIDED|95.0|0.32|1.3|||Cochran-Mantel-Haenszel|||Physical Functioning, Cycle 20 Day 1||1.30|0.32|0.2158
72364766|NCT03038100|144241568|SUPERIORITY||Odds Ratio (OR)|0.84||||0.4762|TWO_SIDED|95.0|0.51|1.37|||Cochran-Mantel-Haenszel|||Physical Functioning, Completion of Treatment/Early Termination Visit||1.37|0.51|0.4762
72364767|NCT03038100|144241568|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.1||||0.7585|TWO_SIDED|95.0|0.61|1.96|||Cochran-Mantel-Haenszel|||Physical Functioning, Post-Treatment Follow Up 3 Months||1.96|0.61|0.7585
72364768|NCT03038100|144241568|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.0||||0.9985|TWO_SIDED|95.0|0.52|1.93|||Cochran-Mantel-Haenszel|||Physical Functioning, Post-Treatment Follow Up 6 Months||1.93|0.52|0.9985
72364769|NCT03038100|144241568|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|2.07||||0.1067|TWO_SIDED|95.0|0.85|5.06|||Cochran-Mantel-Haenszel|||Physical Functioning, Post-Treatment Follow Up 9 Months||5.06|0.85|0.1067
72364770|NCT03038100|144241568|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.42||||0.6171|TWO_SIDED|95.0|0.36|5.61|||Cochran-Mantel-Haenszel|||Physical Functioning, Post-Treatment Follow Up 12 Months||5.61|0.36|0.6171
72364771|NCT03038100|144241568|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.41||||0.8084|TWO_SIDED|95.0|0.08|23.57|||Cochran-Mantel-Haenszel|||Physical Functioning, Post-Treatment Follow Up 18 Months||23.57|0.08|0.8084
72364772|NCT03038100|144241568|SUPERIORITY|Stratified Analysis|Difference in Proportion of Responders|-50.0||||0.3173|TWO_SIDED|95.0|-100.0|94.3|||Cochran-Mantel-Haenszel|||Physical Functioning, Post-Treatment Follow Up 24 Months||94.30|-100.00|0.3173
72364773|NCT03038100|144241568|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.1||||0.6802|TWO_SIDED|95.0|0.69|1.77|||Cochran-Mantel-Haenszel|||Global health status/QoL, Presurgical/Surgery||1.77|0.69|0.6802
72364774|NCT03038100|144241568|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.79||||0.347|TWO_SIDED|95.0|0.48|1.29|||Cochran-Mantel-Haenszel|||Global health status/QoL, Cycle 4 Day 1||1.29|0.48|0.3470
72364775|NCT03038100|144241568|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.86||||0.5564|TWO_SIDED|95.0|0.53|1.41|||Cochran-Mantel-Haenszel|||Global health status/QoL, Cycle 6 Day 1||1.41|0.53|0.5564
72364776|NCT03038100|144241568|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.19||||0.5|TWO_SIDED|95.0|0.72|1.99|||Cochran-Mantel-Haenszel|||Global health status/QoL, Cycle 8 Day 1||1.99|0.72|0.5000
72364777|NCT03038100|144241568|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.01||||0.9778|TWO_SIDED|95.0|0.57|1.78|||Cochran-Mantel-Haenszel|||Global health status/QoL, Cycle 12 Day 1||1.78|0.57|0.9778
72364778|NCT03038100|144241568|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.17||||0.6005|TWO_SIDED|95.0|0.65|2.12|||Cochran-Mantel-Haenszel|||Global health status/QoL, Cycle 16 Day 1||2.12|0.65|0.6005
72364779|NCT03038100|144241568|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.0||||0.99|TWO_SIDED|95.0|0.5|2.0|||Cochran-Mantel-Haenszel|||Global health status/QoL, Cycle 20 Day 1||2.00|0.50|0.9900
72364780|NCT03038100|144241568|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.32||||0.2634|TWO_SIDED|95.0|0.81|2.15|||Cochran-Mantel-Haenszel|||Global health status/QoL, Completion of Treatment/Early Termination Visit||2.15|0.81|0.2634
72364781|NCT03038100|144241568|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.99||||0.964|TWO_SIDED|95.0|0.56|1.74|||Cochran-Mantel-Haenszel|||Global health status/QoL, Post-Treatment Follow Up 3 Months||1.74|0.56|0.9640
72364782|NCT03038100|144241568|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.76||||0.4117|TWO_SIDED|95.0|0.4|1.46|||Cochran-Mantel-Haenszel|||Global health status/QoL, Post-Treatment Follow Up 6 Months||1.46|0.40|0.4117
72364783|NCT03038100|144241568|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.51||||0.3505|TWO_SIDED|95.0|0.63|3.62|||Cochran-Mantel-Haenszel|||Global health status/QoL, Post-Treatment Follow Up 9 Months||3.62|0.63|0.3505
72364784|NCT03038100|144241568|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|2.28||||0.2439|TWO_SIDED|95.0|0.55|9.45|||Cochran-Mantel-Haenszel|||Global health status/QoL, Post-Treatment Follow Up 12 Months||9.45|0.55|0.2439
72364785|NCT03038100|144241568|SUPERIORITY|Stratified Analysis|Difference in Proportion of Responders|33.33||||0.1573|TWO_SIDED|95.0|-44.86|100.0|||Cochran-Mantel-Haenszel|||Global health status/QoL, Post-Treatment Follow Up 18 Months||100.00|-44.86|0.1573
72364786|NCT03038100|144241568|SUPERIORITY|Stratified Analysis|Difference in Proportion of Responders|50.0|||||TWO_SIDED|95.0|-94.3|100.0||||||Global health status/QoL, Post-Treatment Follow Up 24 Months||100.00|-94.30|
72364787|NCT03038100|144241568|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.72||||0.182|TWO_SIDED|95.0|0.45|1.16|||Cochran-Mantel-Haenszel|||Role Functioning, Presurgical/Surgery||1.16|0.45|0.1820
72364788|NCT03038100|144241568|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.47||||0.0046|TWO_SIDED|95.0|0.28|0.8|||Cochran-Mantel-Haenszel|||Role functioning, Cycle 4 Day 1||0.80|0.28|0.0046
72364789|NCT03038100|144241568|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.59||||0.0361|TWO_SIDED|95.0|0.36|0.97|||Cochran-Mantel-Haenszel|||Role functioning, Cycle 6 Day 1||0.97|0.36|0.0361
72364790|NCT03038100|144241568|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.64||||0.0848|TWO_SIDED|95.0|0.39|1.06|||Cochran-Mantel-Haenszel|||Role functioning, Cycle 8 Day 1||1.06|0.39|0.0848
72364791|NCT03038100|144241568|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.64||||0.1224|TWO_SIDED|95.0|0.37|1.13|||Cochran-Mantel-Haenszel|||Role functioning, Cycle 12 Day 1||1.13|0.37|0.1224
72364792|NCT03038100|144241568|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.74||||0.3127|TWO_SIDED|95.0|0.41|1.33|||Cochran-Mantel-Haenszel|||Role functioning, Cycle 16 Day 1||1.33|0.41|0.3127
72364793|NCT03038100|144241568|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.84||||0.6065|TWO_SIDED|95.0|0.42|1.65|||Cochran-Mantel-Haenszel|||Role functioning, Cycle 20 Day 1||1.65|0.42|0.6065
72364794|NCT03038100|144241568|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.74||||0.2173|TWO_SIDED|95.0|0.45|1.2|||Cochran-Mantel-Haenszel|||Role functioning, Completion of Treatment/ Early Termination Visit||1.20|0.45|0.2173
72364795|NCT03038100|144241568|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.64||||0.1316|TWO_SIDED|95.0|0.35|1.15|||Cochran-Mantel-Haenszel|||Role functioning, Post-Treatment Follow Up 3 Months||1.15|0.35|0.1316
72364796|NCT03038100|144241568|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.9||||0.7678|TWO_SIDED|95.0|0.46|1.76|||Cochran-Mantel-Haenszel|||Role functioning, Post-Treatment Follow Up 6 Months||1.76|0.46|0.7678
72364797|NCT03038100|144241568|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.85||||0.7331|TWO_SIDED|95.0|0.34|2.14|||Cochran-Mantel-Haenszel|||Role functioning, Post-Treatment Follow Up 9 Months||2.14|0.34|0.7331
72364798|NCT03038100|144241568|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|2.83||||0.1235|TWO_SIDED|95.0|0.73|10.92|||Cochran-Mantel-Haenszel|||Role functioning, Post-Treatment Follow Up 12 Months||10.92|0.73|0.1235
72364799|NCT03038100|144241568|SUPERIORITY|Stratified Analysis|Difference in Proportion of Responders|0.0|||||TWO_SIDED|95.0|-84.09|84.09||||||Role functioning, Post-Treatment Follow Up 18 Months||84.09|-84.09|
72364800|NCT03038100|144241568|SUPERIORITY|Stratified Analysis|Difference in Proportion of Responders|50.0|||||TWO_SIDED|95.0|-94.3|100.0||||||Role functioning, Post-Treatment Follow Up 24 Months||100.00|-94.30|
72364801|NCT03038100|144241568|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.07||||0.7869|TWO_SIDED|95.0|0.65|1.78|||Cochran-Mantel-Haenszel|||Social functioning, Presurgical/Surgery||1.78|0.65|0.7869
72364802|NCT03038100|144241568|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.73||||0.2502|TWO_SIDED|95.0|0.43|1.25|||Cochran-Mantel-Haenszel|||Social functioning, Cycle 4 Day 1||1.25|0.43|0.2502
72364803|NCT03038100|144241568|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.84||||0.5066|TWO_SIDED|95.0|0.5|1.41|||Cochran-Mantel-Haenszel|||Social functioning, Cycle 6 Day 1||1.41|0.50|0.5066
72364804|NCT03038100|144241568|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.94||||0.8124|TWO_SIDED|95.0|0.56|1.59|||Cochran-Mantel-Haenszel|||Social functioning, Cycle 8 Day 1||1.59|0.56|0.8124
72364805|NCT03038100|144241568|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.23||||0.4656|TWO_SIDED|95.0|0.7|2.17|||Cochran-Mantel-Haenszel|||Social functioning, Cycle 12 Day 1||2.17|0.70|0.4656
72364806|NCT03038100|144241568|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.14||||0.6725|TWO_SIDED|95.0|0.62|2.12|||Cochran-Mantel-Haenszel|||Social functioning, Cycle 16 Day 1||2.12|0.62|0.6725
72364807|NCT03038100|144241568|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.82||||0.578|TWO_SIDED|95.0|0.41|1.64|||Cochran-Mantel-Haenszel|||Social functioning, Cycle 20 Day 1||1.64|0.41|0.5780
72364808|NCT03038100|144241568|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.08||||0.7611|TWO_SIDED|95.0|0.66|1.76|||Cochran-Mantel-Haenszel|||Social functioning, Completion of Treatment/Early Termination Visit||1.76|0.66|0.7611
72364809|NCT03038100|144241568|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.09||||0.7588|TWO_SIDED|95.0|0.62|1.94|||Cochran-Mantel-Haenszel|||Social functioning, Post-Treatment Follow Up 3 Months||1.94|0.62|0.7588
72364810|NCT03038100|144241568|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.6||||0.1428|TWO_SIDED|95.0|0.3|1.19|||Cochran-Mantel-Haenszel|||Social functioning, Post-Treatment Follow Up 6 Months||1.19|0.30|0.1428
72364811|NCT03038100|144241568|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.99||||0.9802|TWO_SIDED|95.0|0.41|2.39|||Cochran-Mantel-Haenszel|||Social functioning, Post-Treatment Follow Up 9 Months||2.39|0.41|0.9802
72364812|NCT03038100|144241568|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|2.34||||0.1967|TWO_SIDED|95.0|0.63|8.7|||Cochran-Mantel-Haenszel|||Social functioning, Post-Treatment Follow Up 12 Months||8.70|0.63|0.1967
72364813|NCT03038100|144241568|SUPERIORITY|Stratified Analysis|Difference in Proportion of Respnders|8.33||||0.4795|TWO_SIDED|95.0|-69.28|85.94|||Cochran-Mantel-Haenszel|||Social functioning, Post-Treatment Follow Up 18 Months||85.94|-69.28|0.4795
72364814|NCT03038100|144241568|SUPERIORITY|Stratified Analysis|Difference in Proportion of Responders|50.0|||||TWO_SIDED|95.0|-94.3|100.0||||||Social functioning, Post-Treatment Follow Up 24 Months||100.00|-94.30|
72364815|NCT03038100|144241569|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.94||||0.6651|TWO_SIDED|95.0|0.7|1.25|||Cochran-Mantel-Haenszel|||Emotional functioning, Cycle 3 Day 1||1.25|0.70|0.6651
72364816|NCT03038100|144241569|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.0||||0.9927|TWO_SIDED|95.0|0.75|1.34|||Cochran-Mantel-Haenszel|||Emotional functioning, Cycle 5 Day 1||1.34|0.75|0.9927
72364817|NCT03038100|144241569|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.03||||0.8209|TWO_SIDED|95.0|0.77|1.39|||Cochran-Mantel-Haenszel|||Emotional functioning, Cycle 8 Day 1||1.39|0.77|0.8209
72364818|NCT03038100|144241569|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.07||||0.6507|TWO_SIDED|95.0|0.79|1.45|||Cochran-Mantel-Haenszel|||Emotional functioning, Cycle 12 Day 1||1.45|0.79|0.6507
72364819|NCT03038100|144241569|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.21||||0.2596|TWO_SIDED|95.0|0.87|1.67|||Cochran-Mantel-Haenszel|||Emotional functioning, Cycle 16 Day 1||1.67|0.87|0.2596
72364820|NCT03038100|144241569|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.09||||0.6532|TWO_SIDED|95.0|0.75|1.58|||Cochran-Mantel-Haenszel|||Emotional functioning, Cycle 20 Day 1||1.58|0.75|0.6532
72364821|NCT03038100|144241569|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.05||||0.7592|TWO_SIDED|95.0|0.76|1.45|||Cochran-Mantel-Haenszel|||Emotional functioning, Completion Of Treatment/ Early Termination Visit||1.45|0.76|0.7592
72364822|NCT03038100|144241569|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.93||||0.7424|TWO_SIDED|95.0|0.62|1.4|||Cochran-Mantel-Haenszel|||Emotional functioning, Post-Treatment Follow Up 3 Months||1.40|0.62|0.7424
72364823|NCT03038100|144241569|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.37||||0.1912|TWO_SIDED|95.0|0.85|2.19|||Cochran-Mantel-Haenszel|||Emotional functioning, Post-Treatment Follow Up 6 Months||2.19|0.85|0.1912
72364824|NCT03038100|144241569|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.83||||0.5526|TWO_SIDED|95.0|0.45|1.53|||Cochran-Mantel-Haenszel|||Emotional functioning, Post-Treatment Follow Up 9 Months||1.53|0.45|0.5526
72364825|NCT03038100|144241569|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.69||||0.3609|TWO_SIDED|95.0|0.32|1.52|||Cochran-Mantel-Haenszel|||Emotional functioning, Post-Treatment Follow Up 12 Months||1.52|0.32|0.3609
72364826|NCT03038100|144241569|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.8||||0.7527|TWO_SIDED|95.0|0.2|3.23|||Cochran-Mantel-Haenszel|||Emotional functioning, Post-Treatment Follow Up 18 Months||3.23|0.20|0.7527
72364827|NCT03038100|144241569|SUPERIORITY|Stratified Analysis|Difference in Proportion of Responders|-33.33|||||TWO_SIDED|95.0|-100.0|75.44||||||Emotional functioning, Post-Treatment Follow Up 24 Months||75.44|-100.00|
72364828|NCT03038100|144241569|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.85||||0.3177|TWO_SIDED|95.0|0.62|1.17|||Cochran-Mantel-Haenszel|||Physical functioning, Cycle 3 Day 1||1.17|0.62|0.3177
72364829|NCT03038100|144241569|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.88||||0.4184|TWO_SIDED|95.0|0.63|1.21|||Cochran-Mantel-Haenszel|||Physical functioning, Cycle 5 Day 1||1.21|0.63|0.4184
72364830|NCT03038100|144241569|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.91||||0.571|TWO_SIDED|95.0|0.67|1.24|||Cochran-Mantel-Haenszel|||Physical functioning, Cycle 8 Day 1||1.24|0.67|0.5710
72364831|NCT03038100|144241569|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.88||||0.3973|TWO_SIDED|95.0|0.65|1.19|||Cochran-Mantel-Haenszel|||Physical functioning, Cycle 12 Day 1||1.19|0.65|0.3973
72364832|NCT03038100|144241569|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.12||||0.5163|TWO_SIDED|95.0|0.8|1.55|||Cochran-Mantel-Haenszel|||Physical functioning, Cycle 16 Day 1||1.55|0.80|0.5163
72364833|NCT03038100|144241569|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.93||||0.6897|TWO_SIDED|95.0|0.64|1.35|||Cochran-Mantel-Haenszel|||Physical functioning, Cycle 20 Day 1||1.35|0.64|0.6897
72364834|NCT03038100|144241569|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.91||||0.5735|TWO_SIDED|95.0|0.67|1.25|||Cochran-Mantel-Haenszel|||Physical functioning, Completion Of Treatment/ Early Termination Visit||1.25|0.67|0.5735
72364835|NCT03038100|144241569|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.75||||0.1414|TWO_SIDED|95.0|0.5|1.1|||Cochran-Mantel-Haenszel|||Physical functioning, Post-Treatment Follow Up 3 Months||1.10|0.50|0.1414
72364836|NCT03038100|144241569|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.96||||0.8655|TWO_SIDED|95.0|0.59|1.55|||Cochran-Mantel-Haenszel|||Physical functioning, Post-Treatment Follow Up 6 Months||1.55|0.59|0.8655
72364837|NCT03038100|144241569|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.72||||0.3017|TWO_SIDED|95.0|0.38|1.35|||Cochran-Mantel-Haenszel|||Physical functioning, Post-Treatment Follow Up 9 Months||1.35|0.38|0.3017
72364838|NCT03038100|144241569|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.6||||0.2325|TWO_SIDED|95.0|0.26|1.39|||Cochran-Mantel-Haenszel|||Physical functioning, Post-Treatment Follow Up 12 Months||1.39|0.26|0.2325
72364839|NCT03038100|144241569|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.33||||0.1717|TWO_SIDED|95.0|0.06|1.69|||Cochran-Mantel-Haenszel|||Physical functioning, Post-Treatment Follow Up 18 Months||1.69|0.06|0.1717
72364840|NCT03038100|144241569|SUPERIORITY|Stratified Analsyis|Difference in Proportion of Responders|16.67|||||TWO_SIDED|95.0|-46.49|79.82||||||Physical functioning, Post-Treatment Follow Up 24 Months||79.82|-46.49|
72364841|NCT03038100|144241569|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.11||||0.4745|TWO_SIDED|95.0|0.84|1.46|||Cochran-Mantel-Haenszel|||Global health status/QoL, Cycle 3 Day 1||1.46|0.84|0.4745
72364842|NCT03038100|144241569|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.92||||0.5499|TWO_SIDED|95.0|0.69|1.22|||Cochran-Mantel-Haenszel|||Global health status/QoL, Cycle 5 Day 1||1.22|0.69|0.5499
72364843|NCT03038100|144241569|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.97||||0.8436|TWO_SIDED|95.0|0.73|1.29|||Cochran-Mantel-Haenszel|||Global health status/QoL, Cycle 8 Day 1||1.29|0.73|0.8436
72364844|NCT03038100|144241569|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.09||||0.5798|TWO_SIDED|95.0|0.81|1.46|||Cochran-Mantel-Haenszel|||Global health status/QoL, Cycle 12 Day 1||1.46|0.81|0.5798
72364845|NCT03038100|144241569|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.02||||0.9094|TWO_SIDED|95.0|0.74|1.39|||Cochran-Mantel-Haenszel|||Global health status/QoL, Cycle 16 Day 1||1.39|0.74|0.9094
72364846|NCT03038100|144241569|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.17||||0.4006|TWO_SIDED|95.0|0.81|1.67|||Cochran-Mantel-Haenszel|||Global health status/QoL, Cycle 20 Day 1||1.67|0.81|0.4006
72364847|NCT03038100|144241569|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.88||||0.4024|TWO_SIDED|95.0|0.65|1.19|||Cochran-Mantel-Haenszel|||Global health status/QoL, Completion of Treatment/ Early Termination Visit||1.19|0.65|0.4024
72364848|NCT03038100|144241569|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.97||||0.8796|TWO_SIDED|95.0|0.67|1.41|||Cochran-Mantel-Haenszel|||Global health status/QoL, Post-Treatment Follow Up 3 Months||1.41|0.67|0.8796
72364849|NCT03038100|144241569|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.83||||0.435|TWO_SIDED|95.0|0.53|1.32|||Cochran-Mantel-Haenszel|||Global health status/QoL, Post-Treatment Follow Up 6 Months||1.32|0.53|0.4350
72364850|NCT03038100|144241569|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.86||||0.6225|TWO_SIDED|95.0|0.47|1.56|||Cochran-Mantel-Haenszel|||Global health status/QoL, Post-Treatment Follow Up 9 Months||1.56|0.47|0.6225
72364851|NCT03038100|144241569|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.8||||0.5775|TWO_SIDED|95.0|0.36|1.77|||Cochran-Mantel-Haenszel|||Global health status/QoL, Post-Treatment Follow Up 12 Months||1.77|0.36|0.5775
72364852|NCT03038100|144241569|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.37||||0.2343|TWO_SIDED|95.0|0.07|1.94|||Cochran-Mantel-Haenszel|||Global health status/QoL, Post-Treatment Follow Up 18 Months||1.94|0.07|0.2343
72364853|NCT03038100|144241569|SUPERIORITY|Stratified Analysis|Difference in Proportion of Responders|-66.67||||0.0833|TWO_SIDED|95.0|-100.0|4.39|||Cochran-Mantel-Haenszel|||Global health status/QoL, Post-Treatment Follow Up 24 Months||4.39|-100.00|0.0833
72364854|NCT03038100|144241569|SUPERIORITY|Superiority|Odds Ratio (OR)|0.93||||0.6012|TWO_SIDED|95.0|0.71|1.21|||Cochran-Mantel-Haenszel|||Role functioning, Cycle 3 Day 1||1.21|0.71|0.6012
72364855|NCT03038100|144241569|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.85||||0.2291|TWO_SIDED|95.0|0.65|1.11|||Cochran-Mantel-Haenszel|||Role functioning, Cycle 5 Day 1||1.11|0.65|0.2291
72364856|NCT03038100|144241569|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.94||||0.6574|TWO_SIDED|95.0|0.71|1.24|||Cochran-Mantel-Haenszel|||Role functioning, Cycle 8 Day 1||1.24|0.71|0.6574
72364857|NCT03038100|144241569|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.01||||0.9217|TWO_SIDED|95.0|0.76|1.35|||Cochran-Mantel-Haenszel|||Role functioning, Cycle 12 Day 1||1.35|0.76|0.9217
72364858|NCT03038100|144241569|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.95||||0.7693|TWO_SIDED|95.0|0.7|1.3|||Cochran-Mantel-Haenszel|||Role functioning, Cycle 16 Day 1||1.30|0.70|0.7693
72364859|NCT03038100|144241569|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.92||||0.647|TWO_SIDED|95.0|0.64|1.31|||Cochran-Mantel-Haenszel|||Role functioning, Cycle 20 Day 1||1.31|0.64|0.6470
72364860|NCT03038100|144241569|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.93||||0.6391|TWO_SIDED|95.0|0.7|1.25|||Cochran-Mantel-Haenszel|||Role functioning, Completion Of Treatment/ Early Termination Visit||1.25|0.70|0.6391
72364861|NCT03038100|144241569|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.73||||0.0892|TWO_SIDED|95.0|0.51|1.05|||Cochran-Mantel-Haenszel|||Role functioning, Post-Treatment Follow Up 3 Months||1.05|0.51|0.0892
72364862|NCT03038100|144241569|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.65||||0.055|TWO_SIDED|95.0|0.41|1.01|||Cochran-Mantel-Haenszel|||Role functioning, Post-Treatment Follow Up 6 Months||1.01|0.41|0.0550
72364863|NCT03038100|144241569|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.49||||0.0168|TWO_SIDED|95.0|0.27|0.88|||Cochran-Mantel-Haenszel|||Role functioning, Post-Treatment Follow Up 9 Months||0.88|0.27|0.0168
72364864|NCT03038100|144241569|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.29||||0.0021|TWO_SIDED|95.0|0.13|0.65|||Cochran-Mantel-Haenszel|||Role functioning, Post-Treatment Follow Up 12 Months||0.65|0.13|0.0021
72364865|NCT03038100|144241569|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.8||||0.7817|TWO_SIDED|95.0|0.17|3.8|||Cochran-Mantel-Haenszel|||Role functioning, Post-Treatment Follow Up 18 Months||3.80|0.17|0.7817
72364866|NCT03038100|144241569|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|-33.33|||||TWO_SIDED|95.0|-100.0|75.44||||||Role functioning, Post-Treatment Follow Up 24 Months||75.44|-100.00|
72364867|NCT03038100|144241569|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.06||||0.6646|TWO_SIDED|95.0|0.8|1.41|||Cochran-Mantel-Haenszel|||Social functioning, Cycle 3 Day 1||1.41|0.80|0.6646
72364868|NCT03038100|144241569|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.98||||0.8677|TWO_SIDED|95.0|0.73|1.3|||Cochran-Mantel-Haenszel|||Social functioning, Cycle 5 Day 1||1.30|0.73|0.8677
72364869|NCT03038100|144241569|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.04||||0.767|TWO_SIDED|95.0|0.79|1.38|||Cochran-Mantel-Haenszel|||Social functioning, Cycle 8 Day 1||1.38|0.79|0.7670
72364870|NCT03038100|144241569|SUPERIORITY||Odds Ratio (OR)|0.95||||0.7487|TWO_SIDED|95.0|0.71|1.28|||Cochran-Mantel-Haenszel|||Social functioning, Cycle 12 Day 1||1.28|0.71|0.7487
72364871|NCT03038100|144241569|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.23||||0.1882|TWO_SIDED|95.0|0.9|1.68|||Cochran-Mantel-Haenszel|||Social functioning, Cycle 16 Day 1||1.68|0.90|0.1882
72364872|NCT03038100|144241569|SUPERIORITY||Odds Ratio (OR)|1.21||||0.3015|TWO_SIDED|95.0|0.84|1.72|||Cochran-Mantel-Haenszel|||Social functioning, Cycle 20 Day 1||1.72|0.84|0.3015
72364873|NCT03038100|144241569|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.98||||0.9059|TWO_SIDED|95.0|0.73|1.32|||Cochran-Mantel-Haenszel|||Social functioning, Completion of Treatment/ Early Termination Visit||1.32|0.73|0.9059
72364874|NCT03038100|144241569|SUPERIORITY||Odds Ratio (OR)|0.93||||0.7125|TWO_SIDED|95.0|0.65|1.35|||Cochran-Mantel-Haenszel|||Social functioning, Post-Treatment Follow Up 3 Months||1.35|0.65|0.7125
72364875|NCT03038100|144241569|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.68||||0.0947|TWO_SIDED|95.0|0.43|1.07|||Cochran-Mantel-Haenszel|||Social functioning, Post-Treatment Follow Up 6 Months||1.07|0.43|0.0947
72364876|NCT03038100|144241569|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.58||||0.0686|TWO_SIDED|95.0|0.32|1.05|||Cochran-Mantel-Haenszel|||Social functioning, Post-Treatment Follow Up 9 Months||1.05|0.32|0.0686
72364877|NCT03038100|144241569|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.39||||0.0175|TWO_SIDED|95.0|0.17|0.86|||Cochran-Mantel-Haenszel|||Social functioning, Post-Treatment Follow Up 12 Months||0.86|0.17|0.0175
72364878|NCT03038100|144241569|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.46||||0.3376|TWO_SIDED|95.0|0.09|2.3|||Cochran-Mantel-Haenszel|||Social functioning, Post-Treatment Follow Up 18 Months||2.30|0.09|0.3376
72364879|NCT03038100|144241569|SUPERIORITY||Difference in Proportion of Responders|-50.0||||0.5637|TWO_SIDED|95.0|-100.0|23.34|||Cochran-Mantel-Haenszel|||Social functioning, Post-Treatment Follow Up 24 Months||23.34|-100.00|0.5637
72364880|NCT03038100|144241570|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.0||||0.977|TWO_SIDED|95.0|0.76|1.3|||Cochran-Mantel-Haenszel|||Emotional Functioning, Cycle 3 Day 1||1.30|0.76|0.9770
72364881|NCT03038100|144241570|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.05||||0.7317|TWO_SIDED|95.0|0.8|1.37|||Cochran-Mantel-Haenszel|||Emotional Functioning, Cycle 5 Day 1||1.37|0.80|0.7317
72364882|NCT03038100|144241570|SUPERIORITY||Odds Ratio (OR)|1.06||||0.6937|TWO_SIDED|95.0|0.8|1.39|||Cochran-Mantel-Haenszel|||Emotional Functioning, Cycle 8 Day 1||1.39|0.80|0.6937
72364883|NCT03038100|144241570|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.88||||0.3916|TWO_SIDED|95.0|0.66|1.18|||Cochran-Mantel-Haenszel|||Emotional Functioning, Cycle 12 Day 1||1.18|0.66|0.3916
72364884|NCT03038100|144241570|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.86||||0.3363|TWO_SIDED|95.0|0.63|1.17|||Cochran-Mantel-Haenszel|||Emotional Functioning, Cycle 16 Day 1||1.17|0.63|0.3363
72364885|NCT03038100|144241570|SUPERIORITY||Odds Ratio (OR)|1.08||||0.6761|TWO_SIDED|95.0|0.75|1.55|||Cochran-Mantel-Haenszel|||Emotional Functioning, Cycle 20 Day 1||1.55|0.75|0.6761
72364886|NCT03038100|144241570|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.94||||0.6997|TWO_SIDED|95.0|0.71|1.26|||Cochran-Mantel-Haenszel|||Emotional Functioning, Completion of Treatment/ Early Termination Visit||1.26|0.71|0.6997
72364887|NCT03038100|144241570|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.19||||0.3592|TWO_SIDED|95.0|0.82|1.72|||Cochran-Mantel-Haenszel|||Emotional Functioning, Post-Treatment Follow Up 3 Months||1.72|0.82|0.3592
72364888|NCT03038100|144241570|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.97||||0.8798|TWO_SIDED|95.0|0.62|1.51|||Cochran-Mantel-Haenszel|||Emotional Functioning, Post-Treatment Follow Up 6 Months||1.51|0.62|0.8798
72364889|NCT03038100|144241570|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.77||||0.3857|TWO_SIDED|95.0|0.43|1.39|||Cochran-Mantel-Haenszel|||Emotional Functioning, Post-Treatment Follow Up 9 Months||1.39|0.43|0.3857
72364890|NCT03038100|144241570|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.85||||0.6854|TWO_SIDED|95.0|0.39|1.85|||Cochran-Mantel-Haenszel|||Emotional Functioning, Post-Treatment Follow Up 12 Months||1.85|0.39|0.6854
72364891|NCT03038100|144241570|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.54||||0.4533|TWO_SIDED|95.0|0.11|2.7|||Cochran-Mantel-Haenszel|||Emotional Functioning, Post-Treatment Follow Up 18 Months||2.70|0.11|0.4533
72364892|NCT03038100|144241570|SUPERIORITY|Stratified Analysis|Difference in Proportion of Responders|-33.33||||0.3173|TWO_SIDED|95.0|-100.0|75.44|||Cochran-Mantel-Haenszel|||Emotional Functioning, Post-Treatment Follow Up 24 Months||75.44|-100.00|0.3173
72364893|NCT03038100|144241570|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.13||||0.3658|TWO_SIDED|95.0|0.87|1.47|||Cochran-Mantel-Haenszel|||Physical functioning, Cycle 3 Day 1||1.47|0.87|0.3658
72364894|NCT03038100|144241570|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.04||||0.7619|TWO_SIDED|95.0|0.8|1.36|||Cochran-Mantel-Haenszel|||Physical functioning, Cycle 5 Day 1||1.36|0.80|0.7619
72364895|NCT03038100|144241570|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.06||||0.658|TWO_SIDED|95.0|0.81|1.4|||Cochran-Mantel-Haenszel|||Physical functioning, Cycle 8 Day 1||1.40|0.81|0.6580
72364896|NCT03038100|144241570|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.18||||0.2726|TWO_SIDED|95.0|0.88|1.57|||Cochran-Mantel-Haenszel|||Physical functioning, Cycle 12 Day 1||1.57|0.88|0.2726
72364897|NCT03038100|144241570|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.94||||0.6973|TWO_SIDED|95.0|0.69|1.29|||Cochran-Mantel-Haenszel|||Physical functioning, Cycle 16 Day 1||1.29|0.69|0.6973
72364898|NCT03038100|144241570|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.15||||0.447|TWO_SIDED|95.0|0.8|1.64|||Cochran-Mantel-Haenszel|||Physical functioning, Cycle 20 Day 1||1.64|0.80|0.4470
72364899|NCT03038100|144241570|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.91||||0.515|TWO_SIDED|95.0|0.68|1.21|||Cochran-Mantel-Haenszel|||Physical functioning, Completion of Treatment/ Early Termination Visit||1.21|0.68|0.5150
72364900|NCT03038100|144241570|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.26||||0.2103|TWO_SIDED|95.0|0.88|1.82|||Cochran-Mantel-Haenszel|||Physical functioning, Post-Treatment Follow Up 3 Months||1.82|0.88|0.2103
72364901|NCT03038100|144241570|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.06||||0.7969|TWO_SIDED|95.0|0.68|1.66|||Cochran-Mantel-Haenszel|||Physical functioning, Post-Treatment Follow Up 6 Months||1.66|0.68|0.7969
72364902|NCT03038100|144241570|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.07||||0.83|TWO_SIDED|95.0|0.6|1.91|||Cochran-Mantel-Haenszel|||Physical functioning, Post-Treatment Follow Up 9 Months||1.91|0.60|0.8300
72364903|NCT03038100|144241570|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.17||||0.6987|TWO_SIDED|95.0|0.53|2.55|||Cochran-Mantel-Haenszel|||Physical functioning, Post-Treatment Follow Up 12 Months||2.55|0.53|0.6987
72364904|NCT03038100|144241570|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|3.32||||0.1441|TWO_SIDED|95.0|0.62|17.77|||Cochran-Mantel-Haenszel|||Physical functioning, Post-Treatment Follow Up 18 Months||17.77|0.62|0.1441
72364905|NCT03038100|144241570|SUPERIORITY|Stratified Analysis|Difference in proportion of Responders|-66.67||||0.3173|TWO_SIDED|95.0|-100.0|4.39|||Cochran-Mantel-Haenszel|||Physical functioning, Post-Treatment Follow Up 24 Months||4.39|-100.00|0.3173
72364906|NCT03038100|144241570|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.96||||0.7591|TWO_SIDED|95.0|0.74|1.25|||Cochran-Mantel-Haenszel|||Global health status/ QoL, Cycle 3 Day 1||1.25|0.74|0.7591
72364907|NCT03038100|144241570|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.09||||0.5403|TWO_SIDED|95.0|0.83|1.42|||Cochran-Mantel-Haenszel|||Global health status/ QoL, Cycle 5 Day 1||1.42|0.83|0.5403
72364908|NCT03038100|144241570|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.17||||0.2654|TWO_SIDED|95.0|0.89|1.55|||Cochran-Mantel-Haenszel|||Global health status/ QoL, Cycle 8 Day 1||1.55|0.89|0.2654
72364909|NCT03038100|144241570|SUPERIORITY||Odds Ratio (OR)|1.1||||0.5138|TWO_SIDED|95.0|0.82|1.48|||Cochran-Mantel-Haenszel|||Global health status/ QoL, Cycle 12 Day 1||1.48|0.82|0.5138
72364910|NCT03038100|144241570|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.22||||0.2138|TWO_SIDED|95.0|0.89|1.67|||Cochran-Mantel-Haenszel|||Global health status/ QoL, Cycle 16 Day 1||1.67|0.89|0.2138
72364911|NCT03038100|144241570|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.26||||0.2114|TWO_SIDED|95.0|0.88|1.82|||Cochran-Mantel-Haenszel|||Global health status/ QoL, Cycle 20 Day 1||1.82|0.88|0.2114
72364912|NCT03038100|144241570|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.14||||0.3938|TWO_SIDED|95.0|0.85|1.53|||Cochran-Mantel-Haenszel|||Global health status/ QoL, Completion of Treatment/ Early Termination Visit||1.53|0.85|0.3938
72364913|NCT03038100|144241570|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.95||||0.7793|TWO_SIDED|95.0|0.65|1.38|||Cochran-Mantel-Haenszel|||Global health status/ QoL, Post-Treatment Follow Up 3 Months||1.38|0.65|0.7793
72364914|NCT03038100|144241570|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.08||||0.737|TWO_SIDED|95.0|0.69|1.39|||Cochran-Mantel-Haenszel|||Global health status/ QoL, Post-Treatment Follow Up 6 Months||1.39|0.69|0.7370
72364915|NCT03038100|144241570|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.99||||0.9658|TWO_SIDED|95.0|0.55|1.79|||Cochran-Mantel-Haenszel|||Global health status/ QoL, Post-Treatment Follow Up 9 Months||1.79|0.55|0.9658
72364916|NCT03038100|144241570|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.66||||0.3015|TWO_SIDED|95.0|0.29|1.46|||Cochran-Mantel-Haenszel|||Global health status/ QoL, Post-Treatment Follow Up 12 Months||1.46|0.29|0.3015
72364917|NCT03038100|144241570|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.77||||0.7534|TWO_SIDED|95.0|0.15|3.94|||Cochran-Mantel-Haenszel|||Global health status/ QoL, Post-Treatment Follow Up 18 Months||3.94|0.15|0.7534
72364918|NCT03038100|144241570|SUPERIORITY|Stratified Analysis|Difference in Proportion of Responders|16.67||||0.5637|TWO_SIDED|95.0|-46.49|79.82|||Cochran-Mantel-Haenszel|||Global health status/ QoL, Post-Treatment Follow Up 24 Months||79.82|-46.49|0.5637
72364919|NCT03038100|144241570|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.8||||0.1177|TWO_SIDED|95.0|0.61|1.06|||Cochran-Mantel-Haenszel|||Role functioning, Cycle 3 Day 1||1.06|0.61|0.1177
72364920|NCT03038100|144241570|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.17||||0.273|TWO_SIDED|95.0|0.88|1.56|||Cochran-Mantel-Haenszel|||Role functioning, Cycle 5 Day 1||1.56|0.88|0.2730
72364921|NCT03038100|144241570|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.99||||0.9306|TWO_SIDED|95.0|0.73|1.33|||Cochran-Mantel-Haenszel|||Role functioning, Cycle 8 Day 1||1.33|0.73|0.9306
72364922|NCT03038100|144241570|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.97||||0.8631|TWO_SIDED|95.0|0.72|1.32|||Cochran-Mantel-Haenszel|||Role functioning, Cycle 12 Day 1||1.32|0.72|0.8631
72364923|NCT03038100|144241570|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.33||||0.0977|TWO_SIDED|95.0|0.95|1.86|||Cochran-Mantel-Haenszel|||Role functioning, Cycle 16 Day 1||1.86|0.95|0.0977
72364924|NCT03038100|144241570|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.43||||0.0726|TWO_SIDED|95.0|0.97|2.1|||Cochran-Mantel-Haenszel|||Role functioning, Cycle 20 Day 1||2.10|0.97|0.0726
72364925|NCT03038100|144241570|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.0||||0.9974|TWO_SIDED|95.0|0.73|1.38|||Cochran-Mantel-Haenszel|||Role functioning, Completion of Treatment/ Early Termination Visit||1.38|0.73|0.9974
72364926|NCT03038100|144241570|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.08||||0.7069|TWO_SIDED|95.0|0.72|1.63|||Cochran-Mantel-Haenszel|||Role functioning, Post-Treatment Follow Up 3 Months||1.63|0.72|0.7069
72364927|NCT03038100|144241570|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.3||||0.3068|TWO_SIDED|95.0|0.78|2.16|||Cochran-Mantel-Haenszel|||Role functioning, Post-Treatment Follow Up 6 Months||2.16|0.78|0.3068
72364928|NCT03038100|144241570|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.64||||0.1375|TWO_SIDED|95.0|0.85|3.16|||Cochran-Mantel-Haenszel|||Role functioning, Post-Treatment Follow Up 9 Months||3.16|0.85|0.1375
72364929|NCT03038100|144241570|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.02||||0.954|TWO_SIDED|95.0|0.46|2.29|||Cochran-Mantel-Haenszel|||Role functioning, Post-Treatment Follow Up 12 Months||2.29|0.46|0.9540
72364930|NCT03038100|144241570|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.53||||0.4283|TWO_SIDED|95.0|0.1|2.64|||Cochran-Mantel-Haenszel|||Role functioning, Post-Treatment Follow Up 18 Months||2.64|0.10|0.4283
72364931|NCT03038100|144241570|SUPERIORITY|Stratified Analysis|Difference in Proportion of Responders|16.67|||||TWO_SIDED|95.0|-95.56|100.0||||||Role functioning, Post-Treatment Follow Up 24 Months||100.00|-95.56|
72364932|NCT03038100|144241570|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.84||||0.2153|TWO_SIDED|95.0|0.64|1.1|||Cochran-Mantel-Haenszel|||Social Functioning, Cycle 3 Day 1||1.10|0.64|0.2153
72364933|NCT03038100|144241570|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.96||||0.7878|TWO_SIDED|95.0|0.73|1.27|||Cochran-Mantel-Haenszel|||Social Functioning, Cycle 5 Day 1||1.27|0.73|0.7878
72364934|NCT03038100|144241570|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.81||||0.1544|TWO_SIDED|95.0|0.61|1.08|||Cochran-Mantel-Haenszel|||Social Functioning, Cycle 8 Day 1||1.08|0.61|0.1544
72364935|NCT03038100|144241570|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.04||||0.8017|TWO_SIDED|95.0|0.77|1.4|||Cochran-Mantel-Haenszel|||Social Functioning, Cycle 12 Day 1||1.40|0.77|0.8017
72364936|NCT03038100|144241570|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.88||||0.4295|TWO_SIDED|95.0|0.63|1.21|||Cochran-Mantel-Haenszel|||Social Functioning, Cycle 16 Day 1||1.21|0.63|0.4295
72364937|NCT03038100|144241570|SUPERIORITY|Stratified Analysis|Odds Ratio, log|0.99||||0.954|TWO_SIDED|95.0|0.68|1.44|||Cochran-Mantel-Haenszel|||Social Functioning, Cycle 20 Day 1||1.44|0.68|0.9540
72364938|NCT03038100|144241570|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.95||||0.7494|TWO_SIDED|95.0|0.69|1.3|||Cochran-Mantel-Haenszel|||Social Functioning, Completion of Treatment/ Early Termination Visit||1.30|0.69|0.7494
72364939|NCT03038100|144241570|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.1||||0.6412|TWO_SIDED|95.0|0.74|1.62|||Cochran-Mantel-Haenszel|||Social Functioning, Post-Treatment Follow Up 3 Months||1.62|0.74|0.6412
72364940|NCT03038100|144241570|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.04||||0.8652|TWO_SIDED|95.0|0.65|1.67|||Cochran-Mantel-Haenszel|||Social Functioning, Post-Treatment Follow Up 6 Months||1.67|0.65|0.8652
72364941|NCT03038100|144241570|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.14||||0.6912|TWO_SIDED|95.0|0.6|2.18|||Cochran-Mantel-Haenszel|||Social Functioning, Post-Treatment Follow Up 9 Months||2.18|0.60|0.6912
72364942|NCT03038100|144241570|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.79||||0.5834|TWO_SIDED|95.0|0.33|1.86|||Cochran-Mantel-Haenszel|||Social Functioning, Post-Treatment Follow Up 12 Months||1.86|0.33|0.5834
72364943|NCT03038100|144241570|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.93||||0.9578|TWO_SIDED|95.0|0.05|16.05|||Cochran-Mantel-Haenszel|||Social Functioning, Post-Treatment Follow Up 18 Months||16.05|0.05|0.9578
72364944|NCT03038100|144241570|SUPERIORITY|Stratified Analysis|Difference in Proportion of Responders|16.67||||0.5637|TWO_SIDED|95.0|-46.49|79.82|||Cochran-Mantel-Haenszel|||Social Functioning, Post-Treatment Follow Up 24 Months||79.82|-46.49|0.5637
72364945|NCT03038100|144241571|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.11||||0.6063|TWO_SIDED|95.0|0.75|1.63|||Cochran-Mantel-Haenszel|||Emotional functioning, Cycle 3 Day 1||1.63|0.75|0.6063
72364946|NCT03038100|144241571|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.9||||0.5739|TWO_SIDED|95.0|0.63|1.29|||Cochran-Mantel-Haenszel|||Emotional functioning, Cycle 5 Day 1||1.29|0.63|0.5739
72364947|NCT03038100|144241571|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.84||||0.3792|TWO_SIDED|95.0|0.56|1.25|||Cochran-Mantel-Haenszel|||Emotional functioning, Cycle 8 Day 1||1.25|0.56|0.3792
72364948|NCT03038100|144241571|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.12||||0.6022|TWO_SIDED|95.0|0.73|1.73|||Cochran-Mantel-Haenszel|||Emotional functioning, Cycle 12 Day 1||1.73|0.73|0.6022
72364949|NCT03038100|144241571|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.94||||0.7893|TWO_SIDED|95.0|0.59|1.49|||Cochran-Mantel-Haenszel|||Emotional functioning, Cycle 16 Day 1||1.49|0.59|0.7893
72364950|NCT03038100|144241571|SUPERIORITY||Odds Ratio (OR)|0.71||||0.2125|TWO_SIDED|95.0|0.42|1.22|||Cochran-Mantel-Haenszel|||Emotional functioning, Cycle 20 Day 1||1.22|0.42|0.2125
72364951|NCT03038100|144241571|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.01||||0.9661|TWO_SIDED|95.0|0.7|1.46|||Cochran-Mantel-Haenszel|||Emotional functioning, Completion of Treatment/ Early Termination Visit||1.46|0.70|0.9661
72364952|NCT03038100|144241571|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.83||||0.4299|TWO_SIDED|95.0|0.52|1.32|||Cochran-Mantel-Haenszel|||Emotional functioning, Post-Treatment Follow Up 3 Months||1.32|0.52|0.4299
72364953|NCT03038100|144241571|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.65||||0.1542|TWO_SIDED|95.0|0.36|1.18|||Cochran-Mantel-Haenszel|||Emotional functioning, Post-Treatment Follow Up 6 Months||1.18|0.36|0.1542
72364954|NCT03038100|144241571|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|2.65||||0.0363|TWO_SIDED|95.0|1.04|6.76|||Cochran-Mantel-Haenszel|||Emotional functioning, Post-Treatment Follow Up 9 Months||6.76|1.04|0.0363
72364955|NCT03038100|144241571|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|2.75||||0.0814|TWO_SIDED|95.0|0.85|8.93|||Cochran-Mantel-Haenszel|||Emotional functioning, Post-Treatment Follow Up 12 Months||8.93|0.85|0.0814
72364956|NCT03038100|144241571|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|4.03||||0.1915|TWO_SIDED|95.0|0.43|38.0|||Cochran-Mantel-Haenszel|||Emotional functioning, Post-Treatment Follow Up 18 Months||38.00|0.43|0.1915
72364957|NCT03038100|144241571|SUPERIORITY|Stratified Analysis|Difference in Proportion of Responders|66.67||||0.3173|TWO_SIDED|95.0|-4.39|100.0|||Cochran-Mantel-Haenszel|||Emotional functioning, Post-Treatment Follow Up 24 Months||100.00|-4.39|0.3173
72364958|NCT03038100|144241571|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.0||||0.9818|TWO_SIDED|95.0|0.73|1.35|||Cochran-Mantel-Haenszel|||Physical functioning, Cycle 3 Day 1||1.35|0.73|0.9818
72364959|NCT03038100|144241571|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.08||||0.6263|TWO_SIDED|95.0|0.8|1.45|||Cochran-Mantel-Haenszel|||Physical functioning, Cycle 5 Day 1||1.45|0.80|0.6263
72364960|NCT03038100|144241571|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.01||||0.9407|TWO_SIDED|95.0|0.73|1.4|||Cochran-Mantel-Haenszel|||Physical functioning, Cycle 8 Day 1||1.40|0.73|0.9407
72364961|NCT03038100|144241571|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.94||||0.77|TWO_SIDED|95.0|0.64|1.39|||Cochran-Mantel-Haenszel|||Physical functioning, Cycle 12 Day 1||1.39|0.64|0.7700
72364962|NCT03038100|144241571|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.96||||0.8458|TWO_SIDED|95.0|0.63|1.45|||Cochran-Mantel-Haenszel|||Physical functioning, Cycle 16 Day 1||1.45|0.63|0.8458
72364963|NCT03038100|144241571|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.91||||0.7028|TWO_SIDED|95.0|0.57|1.46|||Cochran-Mantel-Haenszel|||Physical functioning, Cycle 20 Day 1||1.46|0.57|0.7028
72364964|NCT03038100|144241571|SUPERIORITY||Odds Ratio (OR)|1.3||||0.1391|TWO_SIDED|95.0|0.92|1.83|||Cochran-Mantel-Haenszel|||Physical functioning, Completion of Treatment/ Early Termination Visit||1.83|0.92|0.1391
72364965|NCT03038100|144241571|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.06||||0.8002|TWO_SIDED|95.0|0.69|1.62|||Cochran-Mantel-Haenszel|||Physical functioning, Post-Treatment Follow Up 3 Months||1.62|0.69|0.8002
72364966|NCT03038100|144241571|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.01||||0.9751|TWO_SIDED|95.0|0.6|1.68|||Cochran-Mantel-Haenszel|||Physical functioning, Post-Treatment Follow Up 6 Months||1.68|0.60|0.9751
72364967|NCT03038100|144241571|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.37||||0.3811|TWO_SIDED|95.0|0.68|2.78|||Cochran-Mantel-Haenszel|||Physical functioning, Post-Treatment Follow Up 9 Months||2.78|0.68|0.3811
72364968|NCT03038100|144241571|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.51||||0.395|TWO_SIDED|95.0|0.58|3.9|||Cochran-Mantel-Haenszel|||Physical functioning, Post-Treatment Follow Up 12 Months||3.90|0.58|0.3950
72364969|NCT03038100|144241571|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.89||||0.8993|TWO_SIDED|95.0|0.16|5.12|||Cochran-Mantel-Haenszel|||Physical functioning, Post-Treatment Follow Up 18 Months||5.12|0.16|0.8993
72364970|NCT03038100|144241571|SUPERIORITY|Stratified|Difference in Proportion of Responders|50.0||||0.3173|TWO_SIDED|95.0|-23.34|100.0|||Cochran-Mantel-Haenszel|||Physical functioning, Post-Treatment Follow Up 24 Months||100.00|-23.34|0.3173
72364971|NCT03038100|144241571|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.92||||0.5988|TWO_SIDED|95.0|0.68|1.25|||Cochran-Mantel-Haenszel|||Global health status/QoL, Cycle 3 Day 1||1.25|0.68|0.5988
72364972|NCT03038100|144241571|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.98||||0.8859|TWO_SIDED|95.0|0.72|1.34|||Cochran-Mantel-Haenszel|||Global health status/QoL, Cycle 5 Day 1||1.34|0.72|0.8859
72364973|NCT03038100|144241571|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.82||||0.2531|TWO_SIDED|95.0|0.58|1.16|||Cochran-Mantel-Haenszel|Stratified Analysis||Global health status/QoL, Cycle 8 Day 1||1.16|0.58|0.2531
72364974|NCT03038100|144241571|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.69||||0.0785|TWO_SIDED|95.0|0.46|1.04|||Cochran-Mantel-Haenszel|||Global health status/QoL, Cycle 12 Day 1||1.04|0.46|0.0785
72364975|NCT03038100|144241571|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.67||||0.0641|TWO_SIDED|95.0|0.43|1.03|||Cochran-Mantel-Haenszel|||Global health status/QoL, Cycle 16 Day 1||1.03|0.43|0.0641
72364976|NCT03038100|144241571|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.48||||0.0046|TWO_SIDED|95.0|0.29|0.8|||Cochran-Mantel-Haenszel|||Global health status/QoL, Cycle 20 Day 1||0.80|0.29|0.0046
72364977|NCT03038100|144241571|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.98||||0.8928|TWO_SIDED|95.0|0.7|1.37|||Cochran-Mantel-Haenszel|||Global health status/QoL, Completion of Treatment/ Early Termination Visit||1.37|0.70|0.8928
72364978|NCT03038100|144241571|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.12||||0.6106|TWO_SIDED|95.0|0.72|1.74|||Cochran-Mantel-Haenszel|||Global health status/QoL, Post-Treatment Follow Up 3 Months||1.74|0.72|0.6106
72364979|NCT03038100|144241571|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.15||||0.6159|TWO_SIDED|95.0|0.67|1.95|||Cochran-Mantel-Haenszel|||Global health status/QoL, Post-Treatment Follow Up 6 Months||1.95|0.67|0.6159
72364980|NCT03038100|144241571|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.24||||0.5372|TWO_SIDED|95.0|0.62|2.49|||Cochran-Mantel-Haenszel|Stratified Analysis||Global health status/QoL, Post-Treatment Follow Up 9 Months||2.49|0.62|0.5372
72364981|NCT03038100|144241571|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|2.22||||0.0845|TWO_SIDED|95.0|0.89|5.58|||Cochran-Mantel-Haenszel|||Global health status/QoL, Post-Treatment Follow Up 12 Months||5.58|0.89|0.0845
72364982|NCT03038100|144241571|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|3.67||||0.1344|TWO_SIDED|95.0|0.62|21.56|||Cochran-Mantel-Haenszel|||Global health status/QoL, Post-Treatment Follow Up 18 Months||21.56|0.62|0.1344
72364983|NCT03038100|144241571|SUPERIORITY|Stratified Analysis|Difference in Proportion of Responders|50.0||||0.3173|TWO_SIDED|95.0|-23.34|100.0|||Cochran-Mantel-Haenszel|||Global health status/QoL, Post-Treatment Follow Up 24 Months||100.00|-23.34|0.3173
72364984|NCT03038100|144241571|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.41||||0.026|TWO_SIDED|95.0|1.04|1.92|||Cochran-Mantel-Haenszel|||Role functioning, Cycle 3 Day 1||1.92|1.04|0.0260
72364985|NCT03038100|144241571|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.02||||0.9179|TWO_SIDED|95.0|0.75|1.37|||Cochran-Mantel-Haenszel|||Role functioning, Cycle 5 Day 1||1.37|0.75|0.9179
72364986|NCT03038100|144241571|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.1||||0.582|TWO_SIDED|95.0|0.79|1.53|||Cochran-Mantel-Haenszel|||Role functioning, Cycle 8 Day 1||1.53|0.79|0.5820
72364987|NCT03038100|144241571|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.99||||0.9772|TWO_SIDED|95.0|0.67|1.47|||Cochran-Mantel-Haenszel|||Role functioning, Cycle 12 Day 1||1.47|0.67|0.9772
72364988|NCT03038100|144241571|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.73||||0.13|TWO_SIDED|95.0|0.49|1.1|||Cochran-Mantel-Haenszel|||Role functioning, Cycle 16 Day 1||1.10|0.49|0.1300
72364989|NCT03038100|144241571|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.66||||0.099|TWO_SIDED|95.0|0.4|1.08|||Cochran-Mantel-Haenszel|||Role functioning, Cycle 20 Day 1||1.08|0.40|0.0990
72431644|NCT00951561|144375278|NON_INFERIORITY_OR_EQUIVALENCE|The sample size calculation is performed in nQuery version 5.0 with the following stipulations: alpha is 0.05; response for both ibuprofen and Vipon is 85%; delta is 10%; no difference in response rates is expected between the two treatment arms, and power is 80%. This calculation is performed for an equivalence/non-inferiority primary analysis.|Difference in % of Uses from Mixed Model|-1.6|||<|0.05||95.0|||||Mixed Models Analysis|||||||<0.05
72431645|NCT02403674|144375281|NON_INFERIORITY|Non-inferiority was declared if the lower bound of the 95% CI of the mean treatment difference was greater than -10.|Difference in percentages|3.537|||||TWO_SIDED|95.0|-1.951|9.026|||||The 95% CIs for difference in percentages were calculated using stratum-adjusted Mantel-Haenszel method for each stratum (HIV-1 RNA ≤100,000 or \>100,000 copies/mL).|||9.026|-1.951|
72431646|NCT02403674|144375282|SUPERIORITY|Superiority was declared when the 1-sided p-value comparing treatment difference was \<0.02497.|Difference in percentages|-28.3|||<|0.001|TWO_SIDED|95.0|-34.0|-22.5||2-sided P-value|t-test, 2 sided||95% CIs were calculated using the Miettinen and Nurminen method.|Dizziness difference||-22.5|-34.0|<0.001
72431647|NCT02403674|144375282|SUPERIORITY|Superiority was declared when the 1-sided p-value comparing treatment difference was \<0.02497.|Difference in percentages|-13.5|||<|0.001|TWO_SIDED|95.0|-19.1|-7.9||2-sided P-value|t-test, 2 sided||95% CIs were calculated using the Miettinen and Nurminen method.|Sleep disorders and disturbances difference||-7.9|-19.1|<0.001
72431648|NCT02403674|144375282|SUPERIORITY|Superiority was declared when the 1-sided p-value comparing treatment difference was \<0.02497.|Difference in percentages|-3.8||||0.033|TWO_SIDED|95.0|-7.6|-0.3||2-sided P-value|t-test, 2 sided||95% CIs were calculated using the Miettinen and Nurminen method.|Altered sensorium difference||-0.3|-7.6|0.033
72431649|NCT02403674|144375283|NON_INFERIORITY|Non-inferiority was declared if the lower bound of the 95% CI of the mean treatment difference was greater than -10|Difference in percentages|3.815|||||TWO_SIDED|95.0|-2.412|10.042|||||The 95% CIs for difference in percentages were calculated using stratum-adjusted Mantel-Haenszel method for each stratum (HIV-1 RNA ≤100,000 or \>100,000 copies/mL).|||10.042|-2.412|
72431650|NCT02403674|144375284|NON_INFERIORITY|Non-inferiority was declared if the lower bound of the 95% CI of the mean treatment difference was greater than -10.|Difference in percentages|4.1|||||TWO_SIDED|95.0|-1.5|9.7|||||The 95% CIs for difference in percentages were calculated using stratum-adjusted Mantel-Haenszel method for each stratum (HIV-1 RNA ≤100,000 or \>100,000 copies/mL).|||9.7|-1.5|
72431651|NCT02403674|144375285|NON_INFERIORITY|Non-inferiority was declared if the lower bound of the 95% CI of the mean treatment difference was greater than -10|Difference in percentages|3.268|||||TWO_SIDED|95.0|-3.057|9.593|||||The 95% CIs for difference in percentages were calculated using stratum-adjusted Mantel-Haenszel method for each stratum (HIV-1 RNA ≤100,000 or \>100,000 copies/mL).|||9.593|-3.057|
72431652|NCT02403674|144375286|SUPERIORITY|Superiority was declared when group difference (MK-1439A-ATRIPLA®) was a positive value.|Difference in mean %change from baseline|10.1|||||TWO_SIDED|95.0|-16.1|36.3|||||95% CIs were calculated based on t-distribution.|||36.3|-16.1|
72431653|NCT02403674|144375287|SUPERIORITY|Superiority was declared when group difference (MK-1439A-ATRIPLA) was a positive value|Diff in mean % change from baseline|14.7|||||TWO_SIDED|95.0|-18.7|48.2|||||The 95% CI for mean difference in CD4 change was based on t-distribution.|||48.2|-18.7|
72431654|NCT02403674|144375288|OTHER|Difference in percentage of participants with ≥1 AE(s)|Difference in percentages|-8.0|||||TWO_SIDED|95.0|-13.0|-3.1|||||95% CIs were calculated with the Miettinen \& Nurminen method.|||-3.1|-13.0|
72431655|NCT02403674|144375289|OTHER|Difference in percentage of participants with ≥1 AE(s)|Difference in percentages|-3.6|||||TWO_SIDED|95.0|-6.9|-0.5|||||95% CIs were calculated with the Miettinen \& Nurminen method.|||-0.5|-6.9|
72431656|NCT02403674|144375290|SUPERIORITY|Superiority was declared when the 1-sided p-value comparing treatment difference was \<0.02497.|Difference in percentages|-2.5|||<|0.001|TWO_SIDED|95.0|-5.9|0.8||2-sided P-value|t-test, 2 sided||95% CIs were calculated using the Miettinen and Nurminen method.|Depression and suicide/self-injury difference||0.8|-5.9|<0.001
72431657|NCT02403674|144375290|SUPERIORITY|Superiority was declared when the 1-sided p-value comparing treatment difference was \<0.02497.|Difference in percentages|-0.8|||<|0.001|TWO_SIDED|95.0|-2.5|0.5||2-sided P-value|t-test, 2 sided||95% CIs were calculated using the Miettinen and Nurminen method.|Psychosis and psychotic disorders difference||0.5|-2.5|<0.001
72431658|NCT02403674|144375291|SUPERIORITY||Difference in mean %change from baseline|-10.01|||<|0.0001|TWO_SIDED|95.0|-13.53|-6.49|||ANCOVA||95% CIs and 2-sided p-values for treatment difference were calculated from an ANCOVA model with terms for baseline lipid level and treatment.|||-6.49|-13.53|<0.0001
72431659|NCT02403674|144375292|SUPERIORITY||Difference in mean %change from baseline|-17.02|||<|0.0001|TWO_SIDED|95.0|-20.89|-13.16|||ANCOVA||95% CIs and 2-sided p-values for treatment difference were calculated from an ANCOVA model with terms for baseline lipid level and treatment.|||-13.16|-20.89|<0.0001
72431660|NCT02403674|144375293|SUPERIORITY||Difference in mean %change from baseline|-23.44|||||TWO_SIDED|95.0|-27.57|-19.32|||||95% CIs for treatment difference were calculated from an ANCOVA model with terms for baseline lipid level and treatment.|||-19.32|-27.57|
72431661|NCT02403674|144375294|SUPERIORITY||Difference in mean %change from baseline|-35.96|||||TWO_SIDED|95.0|-47.1|-24.82|||||95% CIs for treatment difference were calculated from an ANCOVA model with terms for baseline lipid level and treatment.|||-24.82|-47.10|
72431662|NCT02403674|144375295|SUPERIORITY||Difference in mean %change from baseline|-6.47|||||TWO_SIDED|95.0|-7.97|-4.96|||||95% CIs for treatment difference were calculated from an ANCOVA model with terms for baseline lipid level and treatment.|||-4.96|-7.97|
72431663|NCT01161160|144375340|NON_INFERIORITY|Equivalence criteria were fulfilled if the 2-sided 95% confidence limits on the geometric mean titer (GMT) ratio was within the interval 0.5 to 2.0.|Adjusted GMT ratio|0.96|||||TWO_SIDED|95.0|0.73|1.26||||||To demonstrate the immunological equivalence of HA antigen adjuvanted with AS03B manufactured in Quebec (Arepanrix™) and HA antigen adjuvanted with AS03B manufactured in Dresden (Pandemrix™), 21 days after vaccination.||1.26|0.73|
72431664|NCT00495469|144375411|OTHER|Tukey's trend test for dose response||||||0.003||||||Tukey's trend test adjusts for multiplicity with statistical significance based on p-value \<0.05|ANCOVA|Change=Baseline+Treatment||||||0.003
72364990|NCT03038100|144241571|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.07||||0.7133|TWO_SIDED|95.0|0.76|1.5|||Cochran-Mantel-Haenszel|||Role functioning, Completion of Treatment/ Early Termination Visit||1.50|0.76|0.7133
72364991|NCT03038100|144241571|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.38||||0.1384|TWO_SIDED|95.0|0.9|2.11|||Cochran-Mantel-Haenszel|||Role functioning, Post-Treatment Follow Up 3 Months||2.11|0.90|0.1384
72364992|NCT03038100|144241571|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.33||||0.2895|TWO_SIDED|95.0|0.78|2.26|||Cochran-Mantel-Haenszel|||Role functioning, Post-Treatment Follow Up 6 Months||2.26|0.78|0.2895
72364993|NCT03038100|144241571|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.55||||0.2221|TWO_SIDED|95.0|0.77|3.14|||Cochran-Mantel-Haenszel|||Role functioning, Post-Treatment Follow Up 9 Months||3.14|0.77|0.2221
72364994|NCT03038100|144241571|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|7.37||||0.0005|TWO_SIDED|95.0|2.08|26.1|||Cochran-Mantel-Haenszel|||Role functioning, Post-Treatment Follow Up 12 Months||26.10|2.08|0.0005
72364995|NCT03038100|144241571|SUPERIORITY||Odds Ratio (OR)|3.72||||0.2171|TWO_SIDED|95.0|0.4|34.56|||Cochran-Mantel-Haenszel|||Role functioning, Post-Treatment Follow Up 18 Months||34.56|0.40|0.2171
72364996|NCT03038100|144241571|SUPERIORITY|Stratified Analysis|Difference in Proportion of Responders|16.67|||||TWO_SIDED|95.0|-46.49|79.82||||||Role functioning, Post-Treatment Follow Up 24 Months||79.82|-46.49|
72364997|NCT03038100|144241571|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.11||||0.4647|TWO_SIDED|95.0|0.84|1.48|||Cochran-Mantel-Haenszel|||Social functioning, Cycle 3 Day 1||1.48|0.84|0.4647
72364998|NCT03038100|144241571|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.04||||0.7676|TWO_SIDED|95.0|0.78|1.4|||Cochran-Mantel-Haenszel|||Social functioning, Cycle 5 Day 1||1.40|0.78|0.7676
72431665|NCT00495469|144375411|OTHER|Tukey's trend test for dose response||||||0.047||||||Tukey's trend test adjusts for multiplicity with statistical significance based on p-value \<0.05.|ANCOVA|Change=Baseline+Treatment||||||0.047
72364999|NCT03038100|144241571|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.24||||0.1983|TWO_SIDED|95.0|0.89|1.71|||Cochran-Mantel-Haenszel|||Social functioning, Cycle 8 Day 1||1.71|0.89|0.1983
72365000|NCT03038100|144241571|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.0||||0.9874|TWO_SIDED|95.0|0.69|1.44|||Cochran-Mantel-Haenszel|||Social functioning, Cycle 12 Day 1||1.44|0.69|0.9874
72365001|NCT03038100|144241571|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.86||||0.4716|TWO_SIDED|95.0|0.58|1.29|||Cochran-Mantel-Haenszel|||Social functioning, Cycle 16 Day 1||1.29|0.58|0.4716
72365002|NCT03038100|144241571|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.74||||0.2041|TWO_SIDED|95.0|0.46|1.18|||Cochran-Mantel-Haenszel|||Social functioning, Cycle 20 Day 1||1.18|0.46|0.2041
72365003|NCT03038100|144241571|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.05||||0.7771|TWO_SIDED|95.0|0.76|1.45|||Cochran-Mantel-Haenszel|||Social functioning, Completion of Treatment/ Early Termination Visit||1.45|0.76|0.7771
72365004|NCT03038100|144241571|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.96||||0.8542|TWO_SIDED|95.0|0.64|1.45|||Cochran-Mantel-Haenszel|||Social functioning, Post-Treatment Follow Up 3 Months||1.45|0.64|0.8542
72365005|NCT03038100|144241571|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.5||||0.123|TWO_SIDED|95.0|0.9|2.5|||Cochran-Mantel-Haenszel|||Social functioning, Post-Treatment Follow Up 6 Months||2.50|0.90|0.1230
72365006|NCT03038100|144241571|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.72||||0.1089|TWO_SIDED|95.0|0.88|3.34|||Cochran-Mantel-Haenszel|||Social functioning, Post-Treatment Follow Up 9 Months||3.34|0.88|0.1089
72365007|NCT03038100|144241571|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|5.82||||0.0011|TWO_SIDED|95.0|1.85|18.3|||Cochran-Mantel-Haenszel|||Social functioning, Post-Treatment Follow Up 12 Months||18.30|1.85|0.0011
72365008|NCT03038100|144241571|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|2.51||||0.295|TWO_SIDED|95.0|0.43|14.74|||Cochran-Mantel-Haenszel|||Social functioning, Post-Treatment Follow Up 18 Months||14.74|0.43|0.2950
72365009|NCT03038100|144241571|SUPERIORITY|Stratified Analysis|Difference in Proportion of Responders|33.33|||||TWO_SIDED|95.0|-37.72|100.0||||||Social functioning, Post-Treatment Follow Up 24 Months||100.00|-37.72|
72365010|NCT02392624|144241576|SUPERIORITY||Clinical Worsening Rate Difference|-39.4|||<|0.0001|TWO_SIDED|95.0|-54.5|-22.5|||Chi-squared|||For participants who transitioned to open-label omalizumab, data prior to the date of transitioning was used for analysis.||-22.5|-54.5|<0.0001
72365011|NCT02392624|144241577|SUPERIORITY||||||<|0.0001|||||||Log Rank|||For participants who transitioned to open-label omalizumab, data prior to the date of transitioning was used for analysis.||||<0.0001
72365012|NCT02392624|144241578|SUPERIORITY||Clinical Worsening Rate Difference|-32.1||||0.0004|TWO_SIDED|95.0|-47.9|-14.9|||Chi-squared|||For participants who transitioned to open-label omalizumab, data prior to the date of transitioning was used for analysis.||-14.9|-47.9|0.0004
72365013|NCT02392624|144241579|OTHER||||||<|0.0001|||||||One-sample t-test, 1 sided|The p-value from this test was used to determine the importance of continued treatment in this study. P-value is one-sided with alpha = 0.05.||The null hypothesis for this test was that the mean change from Week 24 to Week 48 in UAS7 score was \>/=5 and the alternative hypothesis was that the mean change from Week 24 to Week 48 in UAS7 score was \<5.||||<0.0001
72365014|NCT02392624|144241580|OTHER||||||<|0.0001|||||||One-sample t-test, 2 sided|The p-value from this test was used to evaluate the importance of retreatment after experiencing clinical worsening.||The null hypothesis for this test was that the mean change from the time of retreatment to 12 weeks after retreatment in UAS7 was zero and the alternative hypothesis was that this change was non-zero.||||<0.0001
72365015|NCT03841604|144241597|SUPERIORITY||Mean Difference (Net)|-0.7|STANDARD_ERROR_OF_MEAN|0.52||0.1695|TWO_SIDED|95.0|-1.75|0.32|||Mixed Model Repeated Measures|||||0.32|-1.75|0.1695
72365016|NCT03841604|144241598|OTHER||Least square mean difference|-1.0|STANDARD_ERROR_OF_MEAN|0.55||0.0784|TWO_SIDED|95.0|-2.1|0.12|||Mixed Model Repeated Measures|||||0.12|-2.1|0.0784
72365017|NCT03841604|144241599|OTHER||Risk Difference (RD)|-0.23||||0.0744|TWO_SIDED|95.0|-0.45|-0.01|||Cochran-Mantel-Haenszel|||||-0.01|-0.45|0.0744
72365018|NCT03841604|144241600|OTHER||Mean Difference (Net)|-0.1|STANDARD_ERROR_OF_MEAN|0.3||0.7247|TWO_SIDED|95.0|-0.7|0.49|||Mixed Model Repeated Measures|||||0.49|-0.70|0.7247
72365019|NCT03841604|144241601|OTHER||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|0.2||0.9052|TWO_SIDED|95.0|-0.43|0.38|||Mixed Model Repeated Measures|||||0.38|-0.43|0.9052
72365020|NCT03841604|144241602|OTHER||Mean Difference (Net)|0.1|STANDARD_ERROR_OF_MEAN|0.37||0.7115|TWO_SIDED|95.0|-0.61|0.88|||Mixed Model Repeated Measures|||||0.88|-0.61|0.7115
72431666|NCT00495469|144375411|OTHER|Tukey's trend test for dose response||||||0.006||||||Tukey's trend test adjusts for multiplicity with statistical significance based on p-value \<0.05.|ANCOVA|Change=Baseline+Treatment||||||0.006
72431667|NCT00495469|144375411|OTHER|Tukey's trend test for dose response||||||0.085||||||Tukey's trend test adjusts for multiplicity with statistical significance based on p-value \<0.05.|ANCOVA|Change=Baseline+Treatment||||||0.085
72431668|NCT00495469|144375411|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.34||||0.085|TWO_SIDED|95.0|-0.73|0.05||Pairwise comparison included for informational purposes and not controlled for multiplicity.|ANCOVA|Change=Baseline+Treatment||||0.05|-0.73|0.085
72431669|NCT00495469|144375411|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.56||||0.006|TWO_SIDED|95.0|-0.95|-0.16||Pairwise comparison included for informational purposes and not controlled for multiplicity|ANCOVA|Change=Baseline+Treatment||||-0.16|-0.95|0.006
72431670|NCT00495469|144375411|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.34||||0.084|TWO_SIDED|95.0|-0.73|0.05||Pairwise comparison included for informational purposes and not controlled for multiplicity.|ANCOVA|Change=Baseline+Treatment||||0.05|-0.73|0.084
72431671|NCT00495469|144375411|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.66||||0.001|TWO_SIDED|95.0|-1.05|-0.28||Pairwise comparison included for informational purposes and not controlled for multiplicity.|ANCOVA|Change=Baseline+Treatment||||-0.28|-1.05|0.001
72431672|NCT00495469|144375411|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.59||||0.003|TWO_SIDED|95.0|-0.97|-0.2||Pairwise comparison included for informational purposes and not controlled for multiplicity.|ANCOVA|Change=Baseline+Treatment||||-0.20|-0.97|0.003
72431673|NCT00495469|144375411|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.19||||0.337|TWO_SIDED|95.0|-0.58|0.2||Pairwise comparison included for informational purposes and not controlled for multiplicity.|ANCOVA|Change=Baseline+Treatment||||0.20|-0.58|0.337
72431674|NCT00495469|144375413|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.85||||0.039|TWO_SIDED|95.0|-1.67|-0.04||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change=Baseline+Treatment||||-0.04|-1.67|0.039
72431675|NCT00495469|144375413|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.06||||0.013|TWO_SIDED|95.0|-1.89|-0.23||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change=Baseline+Treatment||||-0.23|-1.89|0.013
72431676|NCT00495469|144375413|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.64||||0.131|TWO_SIDED|95.0|-1.46|0.19||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change=Baseline+Treatment||||0.19|-1.46|0.131
72431677|NCT00495469|144375413|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.95||||0.023|TWO_SIDED|95.0|-1.77|-0.13||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change=Baseline+Treatment||||-0.13|-1.77|0.023
72431678|NCT00495469|144375413|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.13||||0.007|TWO_SIDED|95.0|-1.95|-0.32||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change=Baseline+Treatment||||-0.32|-1.95|0.007
72431679|NCT00495469|144375413|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.51||||0.223|TWO_SIDED|95.0|-1.34|0.32||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change=Baseline+Treatment||||0.32|-1.34|0.223
72431680|NCT00495469|144375414|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-24.1||||0.005|TWO_SIDED|95.0|-40.9|-7.4||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change=Baseline+Treatment||||-7.4|-40.9|0.005
72431681|NCT00495469|144375414|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-35.0|||<|0.001|TWO_SIDED|95.0|-52.5|-17.4||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change=Baseline+Treatment||||-17.4|-52.5|<0.001
72431682|NCT00495469|144375414|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-29.8||||0.001|TWO_SIDED|95.0|-46.9|-12.7||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change=Baseline+Treatment||||-12.7|-46.9|0.001
72431683|NCT00495469|144375414|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-36.5|||<|0.001|TWO_SIDED|95.0|-53.6|-19.5||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change=Baseline+Treatment||||-19.5|-53.6|<0.001
72431684|NCT00495469|144375414|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-29.5||||0.001|TWO_SIDED|95.0|-46.3|-12.7||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change=Baseline+Treatment||||-12.7|-46.3|0.001
72431685|NCT00495469|144375414|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-13.8||||0.114|TWO_SIDED|95.0|-31.0|3.4||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change=Baseline+Treatment||||3.4|-31.0|0.114
72431686|NCT00495469|144375415|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.28||||0.757|TWO_SIDED|95.0|0.27|6.06||Pairwise comparison not controlled for multiplicity.|Regression, Logistic|||Placebo vs GSK189075 100 mg QD: Responders (\<=6.5%)||6.06|0.27|0.757
72431687|NCT00495469|144375415|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.58||||0.58|TWO_SIDED|95.0|0.31|8.01||Pairwise comparison not controlled for multiplicity.|Regression, Logistic|||Placebo vs GSK189075 250 mg QD: Responders (\<=6.5%)||8.01|0.31|0.580
72431688|NCT00495469|144375415|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.13||||0.881|TWO_SIDED|95.0|0.22|5.73||Pairwise comparison not controlled for multiplicity.|Regression, Logistic|||Placebo vs GSK189075 500 mg QD: Responders (\<=6.5%)||5.73|0.22|0.881
72431689|NCT00495469|144375415|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.95||||0.382|TWO_SIDED|95.0|0.44|8.75||Pairwise comparison not controlled for multiplicity.|Regression, Logistic|||Placebo vs GSK189075 1000 mg QD: Responders (\<=6.5%)||8.75|0.44|0.382
72431690|NCT00495469|144375415|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.9||||0.409|TWO_SIDED|95.0|0.42|8.68||Pairwise comparison not controlled for multiplicity.|Regression, Logistic|||Placebo vs GSK189075 250 mg BID: Responders (\<=6.5%)||8.68|0.42|0.409
72431691|NCT00495469|144375415|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.24||||0.795|TWO_SIDED|95.0|0.24|6.29||Pairwise comparison not controlled for multiplicity.|Regression, Logistic|||Placebo vs Pioglitazone 30 mg QD: Responders (\<=6.5%)||6.29|0.24|0.795
72431692|NCT00495469|144375415|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.2||||0.765|TWO_SIDED|95.0|0.36|3.95||Pairwise comparison not controlled for multiplicity.|Regression, Logistic|||Placebo vs GSK189075 100 mg QD: Responders (\<7%)||3.95|0.36|0.765
72431693|NCT00495469|144375415|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.74||||0.1|TWO_SIDED|95.0|0.82|9.09||Pairwise comparison not controlled for multiplicity.|Regression, Logistic|||Placebo vs GSK189075 250 mg QD: Responders (\<7%)||9.09|0.82|0.100
72431694|NCT00495469|144375415|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.28||||0.687|TWO_SIDED|95.0|0.38|4.3||Pairwise comparison not controlled for multiplicity.|Regression, Logistic|||Placebo vs GSK189075 500 mg QD: Responders (\<7%)||4.30|0.38|0.687
72431695|NCT00495469|144375415|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.66||||0.409|TWO_SIDED|95.0|0.5|5.52||Pairwise comparison not controlled for multiplicity.|Regression, Logistic|||Placebo vs GSK189075 1000 mg QD: Responders (\<7%)||5.52|0.50|0.409
72365021|NCT03841604|144241603|SUPERIORITY||Risk Difference (RD)|0.04||||0.1967|TWO_SIDED|95.0|-0.04|0.12|||Cochran-Mantel-Haenszel|||||0.12|-0.04|0.1967
72365022|NCT03841604|144241604|SUPERIORITY||Risk Difference (RD)|0.06||||0.5122|TWO_SIDED|95.0|-0.13|0.26|||Cochran-Mantel-Haenszel|||||0.26|-0.13|0.5122
72365023|NCT03841604|144241606|OTHER||Mean Difference (Net)|-0.4|STANDARD_ERROR_OF_MEAN|1.29||0.7376|TWO_SIDED|95.0|-3.03|2.16|||ANCOVA|||||2.16|-3.03|0.7376
72365024|NCT03841604|144241607|OTHER||Mean Difference (Net)|-2.5|STANDARD_ERROR_OF_MEAN|3.92||0.5349|TWO_SIDED|95.0|-10.33|5.43|||Mixed Model Repeated Measures|||||5.43|-10.33|0.5349
72365025|NCT02085161|144241654|SUPERIORITY_OR_OTHER||Treatment ratio|1.458|STANDARD_ERROR_OF_MEAN|0.147||0.0002|TWO_SIDED|95.0|1.196|1.777||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA|Mean and 95% confidence limits were transformed from log10 back to the original scale. SE was back transformed using the delta method.|Ratio of means calculated as back transformation of difference on log 10 scale between Tio+Olo (5/5 μg) FDC with exercise training (ET) and BM minus Placebo with behavioural modification (BM).|This treatment comparison is the first one in the alpha-protected hierarchical testing chain.||1.777|1.196|0.0002
72365026|NCT02085161|144241654|SUPERIORITY_OR_OTHER||Treatment ratio|1.292|STANDARD_ERROR_OF_MEAN|0.129||0.0109|TWO_SIDED|95.0|1.061|1.573||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA|Mean and 95% confidence limits were transformed from log10 back to the original scale. SE was back transformed using the delta method.|Ratio of means calculated as back transformation of difference on log 10 scale between Tiotropium + olodaterol (Olo) (5/5 μg) FDC with BM minus Placebo with behavioural modification (BM).|This treatment comparison is the second one in the alpha-protected hierarchical testing chain.||1.573|1.061|0.0109
72365027|NCT02085161|144241654|SUPERIORITY_OR_OTHER||Treatment ratio|1.041|STANDARD_ERROR_OF_MEAN|0.106||0.6895|TWO_SIDED|95.0|0.853|1.272||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA|Mean and 95% confidence limits were transformed from log10 back to the original scale. SE was back transformed using the delta method.|Ratio of means calculated as back transformation of difference on log 10 scale between Tiotropium (Tio) 5 micro-grams (μg) with BM minus Placebo with behavioural modification (BM).|This treatment comparison is the third one in the alpha-protected hierarchical testing chain. Since the p-value for this treatment comparison is \>0.05, the hierarchical testing chain is broken and all of the following hypothesis tests in this hierarchical chain are considered as descriptive only.||1.272|0.853|0.6895
72365028|NCT02085161|144241654|SUPERIORITY_OR_OTHER||Treatment ratio|1.128|STANDARD_ERROR_OF_MEAN|0.11||0.2188|TWO_SIDED|95.0|0.931|1.368||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA|Mean and 95% confidence limits were transformed from log10 back to the original scale. SE was back transformed using the delta method.|Ratio of means calculated as back transformation of difference on log 10 scale between Tio+Olo (5/5 μg) FDC with exercise training (ET) and BM minus Tiotropium + olodaterol (Olo) (5/5 μg) FDC with BM.|||1.368|0.931|0.2188
72365029|NCT02085161|144241654|SUPERIORITY_OR_OTHER||Treatment ratio|1.241|STANDARD_ERROR_OF_MEAN|0.123||0.0303|TWO_SIDED|95.0|1.021|1.507||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA|Mean and 95% confidence limits were transformed from log10 back to the original scale. SE was back transformed using the delta method.|Ratio of means calculated as back transformation of difference on log 10 scale between Tiotropium + olodaterol (Olo) (5/5 μg) FDC with BM minus Tiotropium (Tio) 5 micro-grams (μg) with BM.|||1.507|1.021|0.0303
72365030|NCT02085161|144241655|SUPERIORITY_OR_OTHER||LSMean Difference|-331.975|STANDARD_ERROR_OF_MEAN|296.375||0.2639|TWO_SIDED|95.0|-916.015|252.064||An ANCOVA model with categorical effects of treatment and baseline as covariate.|ANCOVA||The LSMean Difference is calculated as Tio+Olo (5/5 μg) FDC with exercise training (ET) and BM minus Placebo with behavioural modification (BM)|||252.064|-916.015|0.2639
72365031|NCT02085161|144241655|SUPERIORITY_OR_OTHER||LSMean Difference|161.072|STANDARD_ERROR_OF_MEAN|293.506||0.5837|TWO_SIDED|95.0|-417.314|739.459||An ANCOVA model with categorical effects of treatment and baseline as covariate.|ANCOVA||The LSMean Difference is calculated as Tiotropium + olodaterol (Olo) (5/5 μg) FDC with BM minus Placebo with behavioural modification (BM)|||739.459|-417.314|0.5837
72365032|NCT02085161|144241655|SUPERIORITY_OR_OTHER||LSMean Difference|-524.926|STANDARD_ERROR_OF_MEAN|296.802||0.0783|TWO_SIDED|95.0|-1109.806|59.954||An ANCOVA model with categorical effects of treatment and baseline as covariate.|ANCOVA||The LSMean Difference is calculated as Tiotropium (Tio) 5 micro-grams (μg) with BM minus Placebo with behavioural modification (BM)|||59.954|-1109.806|0.0783
72365033|NCT02085161|144241655|SUPERIORITY_OR_OTHER||LSMean Difference|-493.048|STANDARD_ERROR_OF_MEAN|289.566||0.09|TWO_SIDED|95.0|-1063.67|77.575||An ANCOVA model with categorical effects of treatment and baseline as covariate.|ANCOVA||The LSMean Difference is calculated as Tio+Olo (5/5 μg) FDC with exercise training (ET) and BM minus Tiotropium + olodaterol (Olo) (5/5 μg) FDC with BM|||77.575|-1063.670|0.0900
72365034|NCT02085161|144241655|SUPERIORITY_OR_OTHER||LSMean Difference|685.998|STANDARD_ERROR_OF_MEAN|289.435||0.0186|TWO_SIDED|95.0|115.635|1256.362||An ANCOVA model with categorical effects of treatment and baseline as covariate.|ANCOVA||The LSMean Difference is calculated as Tiotropium + olodaterol (Olo) (5/5 μg) FDC with BM minus Tiotropium (Tio) 5 micro-grams (μg) with BM|||1256.362|115.635|0.0186
72365035|NCT02085161|144241656|SUPERIORITY_OR_OTHER||LSMean Difference|-0.002|STANDARD_ERROR_OF_MEAN|0.004||0.5186|TWO_SIDED|95.0|-0.01|0.005||An ANCOVA model with categorical effects of treatment and baseline as covariate.|ANCOVA||The LSMean Difference is calculated as Tio+Olo (5/5 μg) FDC with exercise training (ET) and BM minus Placebo with behavioural modification (BM)|||0.005|-0.010|0.5186
72365036|NCT02085161|144241656|SUPERIORITY_OR_OTHER||LSMean Difference|0.002|STANDARD_ERROR_OF_MEAN|0.004||0.6436|TWO_SIDED|95.0|-0.006|0.009||An ANCOVA model with categorical effects of treatment and baseline as covariate.|ANCOVA||The LSMean Difference is calculated as Tiotropium + olodaterol (Olo) (5/5 μg) FDC with BM minus Placebo with behavioural modification (BM)|||0.009|-0.006|0.6436
72365037|NCT02085161|144241656|SUPERIORITY_OR_OTHER||LSMean Difference|-0.006|STANDARD_ERROR_OF_MEAN|0.004||0.1081|TWO_SIDED|95.0|-0.014|0.001||An ANCOVA model with categorical effects of treatment and baseline as covariate.|ANCOVA||The LSMean Difference is calculated as Tiotropium (Tio) 5 micro-grams (μg) with BM minus Placebo with behavioural modification (BM)|||0.001|-0.014|0.1081
72431696|NCT00495469|144375415|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.81||||0.086|TWO_SIDED|95.0|0.86|9.15||Pairwise comparison not controlled for multiplicity.|Regression, Logistic|||Placebo vs GSK189075 250 mg BID: Responders (\<7%)||9.15|0.86|0.086
72365038|NCT02085161|144241656|SUPERIORITY_OR_OTHER||LSMean Difference|-0.004|STANDARD_ERROR_OF_MEAN|0.004||0.2612|TWO_SIDED|95.0|-0.011|0.003||An ANCOVA model with categorical effects of treatment and baseline as covariate.|ANCOVA||The LSMean Difference is calculated as Tio+Olo (5/5 μg) FDC with exercise training (ET) and BM minus Tiotropium + olodaterol (Olo) (5/5 μg) FDC with BM|||0.003|-0.011|0.2612
72365039|NCT02085161|144241656|SUPERIORITY_OR_OTHER||LSMean Difference|0.008|STANDARD_ERROR_OF_MEAN|0.004||0.0361|TWO_SIDED|95.0|0.001|0.015||An ANCOVA model with categorical effects of treatment and baseline as covariate.|ANCOVA||The LSMean Difference is calculated as Tiotropium + olodaterol (Olo) (5/5 μg) FDC with BM minus Tiotropium (Tio) 5 micro-grams (μg) with BM|||0.015|0.001|0.0361
72365040|NCT02085161|144241657|SUPERIORITY_OR_OTHER||LSMean Difference|0.076|STANDARD_ERROR_OF_MEAN|0.056||0.1727|TWO_SIDED|95.0|-0.034|0.187||An ANCOVA model with categorical effects of treatment and baseline as covariate.|ANCOVA||The LSMean Difference is calculated as Tio+Olo (5/5 μg) FDC with exercise training (ET) and BM minus Placebo with behavioural modification (BM)|||0.187|-0.034|0.1727
72365041|NCT02085161|144241657|SUPERIORITY_OR_OTHER||LSMean Difference|0.143|STANDARD_ERROR_OF_MEAN|0.055||0.0097|TWO_SIDED|95.0|0.035|0.252||An ANCOVA model with categorical effects of treatment and baseline as covariate.|ANCOVA||The LSMean Difference is calculated as Tiotropium + olodaterol (Olo) (5/5 μg) FDC with BM minus Placebo with behavioural modification (BM)|||0.252|0.035|0.0097
72365042|NCT02085161|144241657|SUPERIORITY_OR_OTHER||LSMean Difference|0.016|STANDARD_ERROR_OF_MEAN|0.056||0.7815|TWO_SIDED|95.0|-0.095|0.126||An ANCOVA model with categorical effects of treatment and baseline as covariate.|ANCOVA||The LSMean Difference is calculated as Tiotropium (Tio) 5 micro-grams (μg) with BM minus Placebo with behavioural modification (BM)|||0.126|-0.095|0.7815
72365043|NCT02085161|144241657|SUPERIORITY_OR_OTHER||LSMean Difference|-0.067|STANDARD_ERROR_OF_MEAN|0.054||0.2183|TWO_SIDED|95.0|-0.174|0.04||An ANCOVA model with categorical effects of treatment and baseline as covariate.|ANCOVA||The LSMean Difference is calculated as Tio+Olo (5/5 μg) FDC with exercise training (ET) and BM minus Tiotropium + olodaterol (Olo) (5/5 μg) FDC with BM|||0.040|-0.174|0.2183
72365044|NCT02085161|144241657|SUPERIORITY_OR_OTHER||LSMean Difference|0.128|STANDARD_ERROR_OF_MEAN|0.055||0.0203|TWO_SIDED|95.0|0.02|0.236||An ANCOVA model with categorical effects of treatment and baseline as covariate.|ANCOVA||The LSMean Difference is calculated as Tiotropium + olodaterol (Olo) (5/5 μg) FDC with BM minus Tiotropium (Tio) 5 micro-grams (μg) with BM|||0.236|0.020|0.0203
72365045|NCT02085161|144241658|SUPERIORITY_OR_OTHER||Treatment ratio|1.333|STANDARD_ERROR_OF_MEAN|0.142||0.0077|TWO_SIDED|95.0|1.08|1.645||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA|Mean and 95% confidence limits were transformed from log10 back to the original scale. SE was back transformed using the delta method.|Ratio of means calculated as back transformation of difference on log 10 scale between Tio+Olo (5/5 μg) FDC with exercise training (ET) and BM minus Placebo with behavioural modification (BM).|||1.645|1.080|0.0077
72365046|NCT02085161|144241658|SUPERIORITY_OR_OTHER||Treatment ratio|1.244|STANDARD_ERROR_OF_MEAN|0.131||0.039|TWO_SIDED|95.0|1.011|1.53||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA|Mean and 95% confidence limits were transformed from log10 back to the original scale. SE was back transformed using the delta method.|Ratio of means calculated as back transformation of difference on log 10 scale between Tiotropium + olodaterol (Olo) (5/5 μg) FDC with BM minus Placebo with behavioural modification (BM).|||1.530|1.011|0.0390
72365047|NCT02085161|144241658|SUPERIORITY_OR_OTHER||Treatment ratio|1.051|STANDARD_ERROR_OF_MEAN|0.113||0.6452|TWO_SIDED|95.0|0.85|1.299||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA|Mean and 95% confidence limits were transformed from log10 back to the original scale. SE was back transformed using the delta method.|Ratio of means calculated as back transformation of difference on log 10 scale between Tiotropium (Tio) 5 micro-grams (μg) with BM minus Placebo with behavioural modification (BM).|||1.299|0.850|0.6452
72365048|NCT02085161|144241658|SUPERIORITY_OR_OTHER||Treatment ratio|1.071|STANDARD_ERROR_OF_MEAN|0.111||0.5048|TWO_SIDED|95.0|0.874|1.313||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA|Mean and 95% confidence limits were transformed from log10 back to the original scale. SE was back transformed using the delta method.|Ratio of means calculated as back transformation of difference on log 10 scale between Tio+Olo (5/5 μg) FDC with exercise training (ET) and BM minus Tiotropium + olodaterol (Olo) (5/5 μg) FDC with BM.|||1.313|0.874|0.5048
72365049|NCT02085161|144241658|SUPERIORITY_OR_OTHER||Treatment ratio|1.184|STANDARD_ERROR_OF_MEAN|0.123||0.1066|TWO_SIDED|95.0|0.964|1.453||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA|Mean and 95% confidence limits were transformed from log10 back to the original scale. SE was back transformed using the delta method.|Ratio of means calculated as back transformation of difference on log 10 scale between Tiotropium + olodaterol (Olo) (5/5 μg) FDC with BM minus Tiotropium (Tio) 5 micro-grams (μg) with BM.|||1.453|0.964|0.1066
72365050|NCT02085161|144241659|SUPERIORITY_OR_OTHER||LSMean Difference|0.329|STANDARD_ERROR_OF_MEAN|0.038|<|0.0001|TWO_SIDED|95.0|0.255|0.403||Mixed effect Model Repeat Measurement (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect|Mixed Models Analysis|Compound symmetry covariance structure for within-patient variation and Kenward-Roger approximation of denominator degrees of freedom|The LSMean Difference is calculated as Tio+Olo (5/5 μg) FDC with exercise training (ET) and BM minus Placebo with behavioural modification (BM)|||0.403|0.255|<0.0001
72365051|NCT02085161|144241659|SUPERIORITY_OR_OTHER||LSMean Difference|0.356|STANDARD_ERROR_OF_MEAN|0.037|<|0.0001|TWO_SIDED|95.0|0.282|0.429||MMRM model including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect|Mixed Models Analysis|Compound symmetry covariance structure for within-patient variation and Kenward-Roger approximation of denominator degrees of freedom|The LSMean Difference is calculated as Tiotropium + olodaterol (Olo) (5/5 μg) FDC with BM minus Placebo with behavioural modification (BM)|||0.429|0.282|<0.0001
72365052|NCT02085161|144241659|SUPERIORITY_OR_OTHER||LSMean Difference|0.174|STANDARD_ERROR_OF_MEAN|0.038|<|0.0001|TWO_SIDED|95.0|0.099|0.249||MMRM model including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect|Mixed Models Analysis|Compound symmetry covariance structure for within-patient variation and Kenward-Roger approximation of denominator degrees of freedom|The LSMean Difference is calculated as Tiotropium (Tio) 5 micro-grams (μg) with BM minus Placebo with behavioural modification (BM)|||0.249|0.099|<0.0001
72365053|NCT02085161|144241659|SUPERIORITY_OR_OTHER||LSMean Difference|-0.027|STANDARD_ERROR_OF_MEAN|0.037||0.4677|TWO_SIDED|95.0|-0.099|0.045||MMRM model including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect|Mixed Models Analysis|Compound symmetry covariance structure for within-patient variation and Kenward-Roger approximation of denominator degrees of freedom|The LSMean Difference is calculated as Tio+Olo (5/5 μg) FDC with exercise training (ET) and BM minus Tiotropium + olodaterol (Olo) (5/5 μg) FDC with BM|||0.045|-0.099|0.4677
72365054|NCT02085161|144241659|SUPERIORITY_OR_OTHER||LSMean Difference|0.182|STANDARD_ERROR_OF_MEAN|0.037|<|0.0001|TWO_SIDED|95.0|0.109|0.255||MMRM model including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect|Mixed Models Analysis|Compound symmetry covariance structure for within-patient variation and Kenward-Roger approximation of denominator degrees of freedom|The LSMean Difference is calculated as Tiotropium + olodaterol (Olo) (5/5 μg) FDC with BM minus Tiotropium (Tio) 5 micro-grams (μg) with BM|||0.255|0.109|<0.0001
72365055|NCT02085161|144241660|SUPERIORITY_OR_OTHER||LSMean Difference|0.478|STANDARD_ERROR_OF_MEAN|0.065|<|0.0001|TWO_SIDED|95.0|0.35|0.606||Mixed effect Model Repeat Measurement (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect|Mixed Models Analysis|Compound symmetry covariance structure for within-patient variation and Kenward-Roger approximation of denominator degrees of freedom|The LSMean Difference is calculated as Tio+Olo (5/5 μg) FDC with exercise training (ET) and BM minus Placebo with behavioural modification (BM)|||0.606|0.350|<0.0001
72365056|NCT02085161|144241660|SUPERIORITY_OR_OTHER||LSMean Difference|0.53|STANDARD_ERROR_OF_MEAN|0.064|<|0.0001|TWO_SIDED|95.0|0.403|0.657||MMRM model including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect|Mixed Models Analysis|Compound symmetry covariance structure for within-patient variation and Kenward-Roger approximation of denominator degrees of freedom|The LSMean Difference is calculated as Tiotropium + olodaterol (Olo) (5/5 μg) FDC with BM minus Placebo with behavioural modification (BM)|||0.657|0.403|<0.0001
72365057|NCT02085161|144241660|SUPERIORITY_OR_OTHER||LSMean Difference|0.286|STANDARD_ERROR_OF_MEAN|0.066|<|0.0001|TWO_SIDED|95.0|0.157|0.415||MMRM model including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect|Mixed Models Analysis|Compound symmetry covariance structure for within-patient variation and Kenward-Roger approximation of denominator degrees of freedom|The LSMean Difference is calculated as Tiotropium (Tio) 5 micro-grams (μg) with BM minus Placebo with behavioural modification (BM)|||0.415|0.157|<0.0001
72365058|NCT02085161|144241660|SUPERIORITY_OR_OTHER||LSMean Difference|-0.052|STANDARD_ERROR_OF_MEAN|0.063||0.4107|TWO_SIDED|95.0|-0.176|0.072||MMRM model including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect|Mixed Models Analysis|Compound symmetry covariance structure for within-patient variation and Kenward-Roger approximation of denominator degrees of freedom|The LSMean Difference is calculated as Tio+Olo (5/5 μg) FDC with exercise training (ET) and BM minus Tiotropium + olodaterol (Olo) (5/5 μg) FDC with BM|||0.072|-0.176|0.4107
72365059|NCT02085161|144241660|SUPERIORITY_OR_OTHER||LSMean Difference|0.244|STANDARD_ERROR_OF_MEAN|0.064||0.0002|TWO_SIDED|95.0|0.119|0.37||MMRM model including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect|Mixed Models Analysis|Compound symmetry covariance structure for within-patient variation and Kenward-Roger approximation of denominator degrees of freedom|The LSMean Difference is calculated as Tiotropium + olodaterol (Olo) (5/5 μg) FDC with BM minus Tiotropium (Tio) 5 micro-grams (μg) with BM|||0.370|0.119|0.0002
72365060|NCT02085161|144241661|SUPERIORITY_OR_OTHER||LSMean Difference|0.318|STANDARD_ERROR_OF_MEAN|0.071|<|0.0001|TWO_SIDED|95.0|0.179|0.457||Mixed effect Model Repeat Measurement (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect|Mixed Models Analysis|Compound symmetry covariance structure for within-patient variation and Kenward-Roger approximation of denominator degrees of freedom|The LSMean Difference is calculated as Tio+Olo (5/5 μg) FDC with exercise training (ET) and BM minus Placebo with behavioural modification (BM)|||0.457|0.179|<0.0001
72365061|NCT02085161|144241661|SUPERIORITY_OR_OTHER||LSMean Difference|0.302|STANDARD_ERROR_OF_MEAN|0.07|<|0.0001|TWO_SIDED|95.0|0.165|0.439||MMRM model including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect|Mixed Models Analysis|Compound symmetry covariance structure for within-patient variation and Kenward-Roger approximation of denominator degrees of freedom|The LSMean Difference is calculated as Tiotropium + olodaterol (Olo) (5/5 μg) FDC with BM minus Placebo with behavioural modification (BM)|||0.439|0.165|<0.0001
72365062|NCT02085161|144241661|SUPERIORITY_OR_OTHER||LSMean Difference|0.174|STANDARD_ERROR_OF_MEAN|0.071||0.0145|TWO_SIDED|95.0|0.035|0.314||MMRM model including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect|Mixed Models Analysis|Compound symmetry covariance structure for within-patient variation and Kenward-Roger approximation of denominator degrees of freedom|The LSMean Difference is calculated as Tiotropium (Tio) 5 micro-grams (μg) with BM minus Placebo with behavioural modification (BM)|||0.314|0.035|0.0145
72365063|NCT02085161|144241661|SUPERIORITY_OR_OTHER||LSMean Difference|0.016|STANDARD_ERROR_OF_MEAN|0.068||0.815|TWO_SIDED|95.0|-0.118|0.151||MMRM model including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect|Mixed Models Analysis|Compound symmetry covariance structure for within-patient variation and Kenward-Roger approximation of denominator degrees of freedom|The LSMean Difference is calculated as Tio+Olo (5/5 μg) FDC with exercise training (ET) and BM minus Tiotropium + olodaterol (Olo) (5/5 μg) FDC with BM|||0.151|-0.118|0.8150
72368808|NCT02637037|144247320|NON_INFERIORITY_OR_EQUIVALENCE|If the 90% CIs for both dapagliflozin and metformin geometric mean ratio of AUC is entirely contained within an 80.00% to 125.00% interval, it will be concluded the 2 manufacturing sites are bioequivalent.|Ratios of Geometric means|0.97|||||TWO_SIDED|90.0|0.95|1.0||||||Dapagliflozin: Statistical Assessment of Bioequivalence for Dapagliflozin following administration Dapagliflozin/Metformin XR 10/1000 mg for Treatment G and H.||1.00|0.95|
72365064|NCT02085161|144241661|SUPERIORITY_OR_OTHER||LSMean Difference|0.128|STANDARD_ERROR_OF_MEAN|0.069||0.0642|TWO_SIDED|95.0|-0.008|0.263||MMRM model including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect|Mixed Models Analysis|Compound symmetry covariance structure for within-patient variation and Kenward-Roger approximation of denominator degrees of freedom|The LSMean Difference is calculated as Tiotropium + olodaterol (Olo) (5/5 μg) FDC with BM minus Tiotropium (Tio) 5 micro-grams (μg) with BM|||0.263|-0.008|0.0642
72365065|NCT01774721|144241670|SUPERIORITY||Hazard Ratio (HR)|0.589|||<|0.0001|TWO_SIDED|95.0|0.469|0.739|||1-sided stratified log-rank test||Based on stratified Cox regression model|||0.739|0.469|<0.0001
72365066|NCT01774721|144241671|SUPERIORITY||Hazard Ratio (HR)|0.748||||0.0077|TWO_SIDED|95.0|0.591|0.947|||1-sided stratified log-rank test||Based on stratified Cox Regression model|||0.947|0.591|0.0077
72365067|NCT01774721|144241673|SUPERIORITY||Hazard Ratio (HR)|0.622|||<|0.0001|TWO_SIDED|95.0|0.497|0.779|||1-sided stratified log-rank test||Based on stratified Cox regression model|||0.779|0.497|<0.0001
72365068|NCT01774721|144241676|SUPERIORITY||Hazard Ratio (HR)|0.403|||<|0.0001|TWO_SIDED|95.0|0.307|0.529|||1-sided stratified log-rank test||Based on stratified Cox regression model|Comparison of dacomitinib vs gefitinib based on IRC review||0.529|0.307|<0.0001
72365069|NCT01774721|144241676|SUPERIORITY||Hazard Ratio (HR)|0.545|||<|0.0001|TWO_SIDED|95.0|0.418|0.711|||1-sided stratified log-rank test||Based on stratified Cox regression model|Comparison of dacomitinib vs gefitinib based on Investigator assessment||0.711|0.418|<0.0001
72365070|NCT01774721|144241677|SUPERIORITY|||||||0.1942|||||||Cochran-Mantel-Haenszel|||||||0.1942
72365071|NCT01774721|144241678|SUPERIORITY|||||||0.0924|||||||Cochran-Mantel-Haenszel|||||||0.0924
72365072|NCT01774721|144241685|SUPERIORITY||Cox Proportional Hazard|1.173||||0.1641|TWO_SIDED|95.0|0.928|1.483|||Unstratified Log-rank Test|||||1.483|0.928|0.1641
72365073|NCT03651479|144241706|OTHER|||||||0.004|||||||Wilcoxon (Mann-Whitney)|||||||0.004
72365074|NCT02399163|144241721|SUPERIORITY_OR_OTHER||Mean Difference (Net)|16.76|||<|0.0001|TWO_SIDED|95.0|11.061|22.454||From ANOVA: participant (random), treatment (fixed), period (fixed)|ANCOVA||Difference is Placebo dentifrice/Fluoride rinse minus Placebo dentifrice/No rinse such that a positive difference implies a larger response value for the Placebo dentifrice/Fluoride rinse.|||22.454|11.061|<0.0001
72365075|NCT03594110|144241775|SUPERIORITY|"Null hypothesis: There is no difference between the effect of placebo and the effect of empagliflozin.~Two-sided significance level of \<0.0017 required at interim analysis."|Hazard Ratio (HR)|0.72|||<|0.0001|TWO_SIDED|99.83|0.59|0.89|||Regression, Cox||Comparison vs. Placebo|Hazard ratio (HR) of the time to first occurrence of kidney disease progression or CV death. HR is based on a Cox regression model with terms for age, sex, screening diabetes status, local screening estimated glomerular filtration rate Chronic Kidney Disease Epidemiology Collaboration (eGFR (CKD-EPI)), local screening Urine albumin-to-creatinine ratio (UACR), region and treatment.||0.89|0.59|<0.0001
72365076|NCT03594110|144241776|SUPERIORITY|"Null hypothesis: There is no difference between the effect of placebo and the effect of empagliflozin.~Two-sided significance level of \<0.0145 required at interim analysis."|Hazard Ratio (HR)|0.84||||0.1363|TWO_SIDED|98.55|0.63|1.12|||Regression, Cox||Comparison vs. Placebo|Hazard ratio (HR) of the time to first hospitalization for heart failure or cardiovascular death. HR is based on a Cox regression model with terms for age, sex, screening diabetes status, local screening estimated glomerular filtration rate Chronic Kidney Disease Epidemiology Collaboration (eGFR (CKD-EPI)), local screening Urine albumin-to-creatinine ratio (UACR), region and treatment.||1.12|0.63|0.1363
72365077|NCT03594110|144241777|SUPERIORITY|Null hypothesis: There is no difference between the effect of placebo and the effect of empagliflozin. Two-sided significance level of \<0.0097 required at interim analysis.|Hazard Ratio (HR)|0.86||||0.0022|TWO_SIDED|99.03|0.76|0.98|||Joint frailty model||Comparison vs. Placebo|Hazard ratio (HR) of the time to occurrences of all-cause hospitalizations (first and recurrent combined). HR based on an analysis of recurrent events accounting for terminal events using a joint frailty model with terms for age, log(local screening UACR), local screening Chronic Kidney Disease Epidemiology Collaboration (eGFR (CKD-EPI)), treatment, sex, screening diabetes status, region.||0.98|0.76|0.0022
72365078|NCT03594110|144241778|SUPERIORITY|"Null hypothesis: There is no difference between the effect of placebo and the effect of empagliflozin.~Two-sided significance level of \<0.0290 required at interim analysis."|Hazard Ratio (HR)|0.87||||0.2122|TWO_SIDED|97.1|0.68|1.11|||Regression, Cox||Comparison vs. Placebo|Hazard ratio (HR) of the time to death from any cause. HR is based on a Cox regression model with terms for age, sex, screening diabetes status, local screening estimated glomerular filtration rate Chronic Kidney Disease Epidemiology Collaboration (eGFR (CKD-EPI)), local screening Urine albumin-to-creatinine ratio (UACR), region and treatment.||1.11|0.68|0.2122
72365079|NCT03594110|144241779|SUPERIORITY|Null hypothesis: There is no difference between the effect of placebo and the effect of empagliflozin.|Hazard Ratio (HR)|0.71|||<|0.0001|TWO_SIDED|95.0|0.62|0.81|||Regression, Cox||Comparison vs. Placebo|Hazard ratio (HR) of the time to first occurrence of kidney disease progression. HR is based on a Cox regression model with terms for age, sex, screening diabetes status, local screening estimated glomerular filtration rate Chronic Kidney Disease Epidemiology Collaboration (eGFR (CKD-EPI)), local screening urine albumin-to-creatinine ratio (UACR), region and treatment.||0.81|0.62|<0.0001
72365080|NCT03594110|144241780|SUPERIORITY|Null hypothesis: There is no difference between the effect of placebo and the effect of empagliflozin.|Hazard Ratio (HR)|0.83||||0.2932|TWO_SIDED|95.0|0.59|1.17|||Regression, Cox||Comparison vs. Placebo|Hazard ratio (HR) of the time to cardiovascular death. HR is based on a Cox regression model with terms for age, sex, screening diabetes status, local screening estimated glomerular filtration rate Chronic Kidney Disease Epidemiology Collaboration (eGFR (CKD-EPI)), local screening urine albumin-to-creatinine ratio (UACR), region and treatment.||1.17|0.59|0.2932
72365081|NCT03594110|144241781|SUPERIORITY|Null hypothesis: There is no difference between the effect of placebo and the effect of empagliflozin.|Hazard Ratio (HR)|0.72||||0.0017|TWO_SIDED|95.0|0.59|0.89|||Regression, Cox||Comparison vs. Placebo|Hazard ratio (HR) of the time to first occurrence cardiovascular death or end stage kidney disease (ESKD). HR is based on a Cox regression model with terms for age, sex, screening diabetes status, local screening estimated glomerular filtration rate Chronic Kidney Disease Epidemiology Collaboration (eGFR (CKD-EPI)), local screening urine albumin-to-creatinine ratio (UACR), region and treatment.||0.89|0.59|0.0017
72365082|NCT03594110|144241782|OTHER||Hazard Ratio (HR)|0.79|||||TWO_SIDED|95.0|0.72|0.87|||||Comparison vs. Placebo|Hazard ratio (HR) of the time to first occurrence of kidney disease progression or CV death. HR is based on a Cox regression model with terms for age, sex, screening diabetes status, local screening estimated glomerular filtration rate Chronic Kidney Disease Epidemiology Collaboration (eGFR (CKD-EPI)), local screening Urine albumin-to-creatinine ratio (UACR), region and treatment.||0.87|0.72|
72365083|NCT03594110|144241783|OTHER||Hazard Ratio (HR)|0.79|||||TWO_SIDED|95.0|0.72|0.87|||||Comparison vs. Placebo|Hazard ratio (HR) of the time to first occurrence of kidney disease progression. HR is based on a Cox regression model with terms for age, sex, screening diabetes status, local screening estimated glomerular filtration rate Chronic Kidney Disease Epidemiology Collaboration (eGFR (CKD-EPI)), local screening urine albumin-to-creatinine ratio (UACR), region and treatment.||0.87|0.72|
72365084|NCT03594110|144241784|OTHER||Hazard Ratio (HR)|0.81|||||TWO_SIDED|95.0|0.72|0.9|||||Comparison vs. Placebo|Hazard ratio (HR) of the time to first occurrence of death from any cause or ESKD. HR is based on a Cox regression model with terms for age, sex, screening diabetes status, local screening estimated glomerular filtration rate Chronic Kidney Disease Epidemiology Collaboration (eGFR (CKD-EPI)), local screening urine albumin-to-creatinine ratio (UACR), region and treatment.||0.90|0.72|
72365085|NCT03594110|144241785|OTHER||Hazard Ratio (HR)|0.74|||||TWO_SIDED|95.0|0.64|0.87|||||Comparison vs. Placebo|Hazard ratio (HR) of ESKD. HR is based on a Cox regression model with terms for age, sex, screening diabetes status, local screening estimated glomerular filtration rate Chronic Kidney Disease Epidemiology Collaboration (eGFR (CKD-EPI)), local screening urine albumin-to-creatinine ratio (UACR), region and treatment.||0.87|0.64|
72365086|NCT03594110|144241786|OTHER||Mean Difference (Net)|-0.24|||<|0.001|TWO_SIDED|95.0|-0.38|-0.11|||Mixed Models Analysis||\[Comparator\] - \[Placebo\]|A mixed model of repeated measures (MMRM) with terms for baseline, age, sex, screening diabetes status, local screening eGFR, local screening UACR, treatment, treatment-by-time interaction and baseline-by-time interaction.||-0.11|-0.38|< 0.001
72365087|NCT03594110|144241787|OTHER||Mean Difference (Net)|-12.0||||0.41|TWO_SIDED|95.0|-42.0|17.0|||Regression, Linear||\[Comparator\]-\[Placebo\]|Differences in MRI measurements between treatment groups were assessed using a linear regression with terms for age, sex, screening diabetes status, local screening eGFR, local screening UACR was used in the analysis.||17|-42|0.41
72365088|NCT00684021|144241807|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|2.0||0.959|TWO_SIDED|95.0|-4.1|3.9|||t-test, 2 sided|Stem cell treatment arm combined (Day 3 and Day7); placebo group also combined.||||3.9|-4.1|0.959
72365089|NCT00684021|144241808|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.96||||0.93|TWO_SIDED|95.0|0.42|2.23|||Fisher Exact|||Clinical and Safety Outcomes including death, reinfarction, repeat revascularization, hospitalization for heart failure and ICD placement. The relative incidences of events are compared between the active and placebo groups.However the paucity of events precluded a reliable time to event analysis.||2.23|0.42|0.93
72365090|NCT00684021|144241809|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.6|STANDARD_ERROR_OF_MEAN|4.8||0.585|TWO_SIDED|95.0|-12.2|6.9|||Regression, Linear|||Day 3 Stem Cell Arm and Day 7 Stem Cell Arm were combined and compared to the combination of Day 3 Placebo and Day 7 Placebo arms.||6.9|-12.2|0.585
72365091|NCT00684021|144241810|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.8|STANDARD_ERROR_OF_MEAN|3.7||0.831|TWO_SIDED|95.0|-6.6|8.2|||Regression, Linear|||Day 3 Stem Cell Arm and Day 7 Stem Cell Arm were combined and compared to the combination of Day 3 Placebo and Day 7 Placebo arms.||8.2|-6.6|0.831
72365092|NCT00684021|144241811|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.7|STANDARD_ERROR_OF_MEAN|3.7||0.817|TWO_SIDED|95.0|-5.5|7.0|||Regression, Linear|||Day 3 Stem Cell Arm and Day 7 Stem Cell Arm were combined and compared to the combination of Day 3 Placebo and Day 7 Placebo arms.||7.0|-5.5|0.817
72365093|NCT00684021|144241812|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.7|STANDARD_ERROR_OF_MEAN|4.27||0.272|TWO_SIDED|95.0|-13.7|3.67|||Regression, Linear|||Day 3 Stem Cell Arm and Day 7 Stem Cell Arm were combined and compared to the combination of Day 3 Placebo and Day 7 Placebo arms.||3.67|-13.7|0.272
72365094|NCT00684021|144241813|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9|STANDARD_ERROR_OF_MEAN|1.1||0.409|TWO_SIDED|95.0|-3.0|1.2|||t-test, 2 sided|Stem cell treatment arm combined (Day 3 and Day7); placebo group also combined.||||1.2|-3.0|0.409
72365095|NCT00684021|144241813|SUPERIORITY_OR_OTHER||Mean Difference (Net)|100.0|STANDARD_ERROR_OF_MEAN|0.01||0.02|TWO_SIDED|95.0|15.0|1000.0|||Regression, Linear|||||1000|15|0.02
72365096|NCT00684021|144241814|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.5|STANDARD_ERROR_OF_MEAN|1.7||0.777|TWO_SIDED|95.0|-3.9|2.9|||t-test, 2 sided|Stem cell treatment arm combined (Day 3 and Day7); placebo group also combined.||||2.9|-3.9|0.777
72365097|NCT01598532|144241826|SUPERIORITY_OR_OTHER||||||<|0.004|||||||ANOVA|Univariate, one-way, repeated measure ANOVA with trend analysis||linear trend over time for the effect of LED treatments||||<0.004
72365098|NCT01598532|144241827|SUPERIORITY_OR_OTHER||||||<|0.003|||||||ANOVA|Univariate, one-way, repeated measure ANOVA with trend analysis||linear trend over time for the effect of LED treatments||||<0.003
72365099|NCT01598532|144241828|SUPERIORITY_OR_OTHER||||||<|0.003|||||||ANOVA|Univariate, one-way, repeated measure ANOVA with trend analysis||linear trend over time for effect of LED treatments||||<0.003
72365100|NCT01598532|144241829|SUPERIORITY_OR_OTHER||||||<|0.006|||||||ANOVA|Univariate, one-way, repeated measure ANOVA with trend analysis||linear trend over time for the effects of LED treatments||||<0.006
72365101|NCT03873116|144241832|SUPERIORITY||negative binomial regression model|-24.6||||0.181|TWO_SIDED|95.0|-50.1|14.0|||negative binomial regression model|||||14.0|-50.1|0.181
72365102|NCT03873116|144241832|SUPERIORITY||negative binomial regression model|-49.1||||0.003|TWO_SIDED|95.0|-67.5|-20.4|||negative binomial regression model|||||-20.4|-67.5|0.003
72365103|NCT03873116|144241835|SUPERIORITY||Difference in Least Square Means|0.018||||0.814|TWO_SIDED|95.0|-0.143|0.179|||ANCOVA|||Numerical differences from the placebo treatment in the LSM proportion of the 169 days of treatment with angioedema symptoms.||0.179|-0.143|0.814
72365104|NCT03873116|144241835|SUPERIORITY||Difference in Least Square Means|-0.122||||0.12|TWO_SIDED|95.0|-0.28|0.036|||ANCOVA|||Numerical differences from the placebo treatment in the LSM proportion of the 169 days of treatment with angioedema symptoms.||0.036|-0.280|0.120
72431697|NCT00495469|144375415|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.75||||0.369|TWO_SIDED|95.0|0.52|5.88||Pairwise comparison not controlled for multiplicity.|Regression, Logistic|||Placebo vs Pioglitazone 30 mg QD: Responders (\<7%)||5.88|0.52|0.369
72365105|NCT03873116|144241836|SUPERIORITY||mixed-model repeated measures analysis|24.5||||0.188|TWO_SIDED|95.0|-14.7|50.3|||mixed-model repeated measures analysis|||In the event that the first secondary endpoint did not meet statistical significance in the hierarchical testing scheme, testing of the second secondary endpoint of rate of expert-confirmed angioedema events during dosing in the effective treatment period for statistical significance would not be completed. Therefore, P-values reported are nominal.||50.3|-14.7|0.188
72431698|NCT00495469|144375415|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.17||||0.16|TWO_SIDED|95.0|0.74|6.4||Pairwise comparison not controlled for multiplicity.|Regression, Logistic|||Placebo vs GSK189075 100 mg QD: Responders (reduction\>=0.7%)||6.40|0.74|0.160
72431699|NCT00495469|144375415|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.87||||0.014|TWO_SIDED|95.0|1.31|11.42||Pairwise comparison not controlled for multiplicity.|Regression, Logistic|||Placebo vs GSK189075 250 mg QD: Responders (reduction\>=0.7%)||11.42|1.31|0.014
72431700|NCT00495469|144375415|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.17||||0.162|TWO_SIDED|95.0|0.73|6.44||Pairwise comparison not controlled for multiplicity.|Regression, Logistic|||Placebo vs GSK189075 250 mg QD: Responders (reduction\>=0.7%)||6.44|0.73|0.162
72431701|NCT00495469|144375415|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.09||||0.011|TWO_SIDED|95.0|1.38|12.17||Pairwise comparison not controlled for multiplicity.|Regression, Logistic|||Placebo vs GSK189075 1000 mg QD: Responders (reduction\>=0.7%)||12.17|1.38|0.011
72431702|NCT00495469|144375415|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.31||||0.003|TWO_SIDED|95.0|1.79|15.73||Pairwise comparison not controlled for multiplicity.|Regression, Logistic|||Placebo vs GSK189075 250 mg BID: Responders (reduction\>=0.7%)||15.73|1.79|0.003
72431703|NCT00495469|144375415|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.86||||0.264|TWO_SIDED|95.0|0.63|5.49||Pairwise comparison not controlled for multiplicity.|Regression, Logistic|||Placebo vs Pioglitazone 30 mg QD: Responders (reduction\>=0.7%)||5.49|0.63|0.264
72431704|NCT00495469|144375416|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.55||||0.48|TWO_SIDED|95.0|0.46|5.28||Pairwise comparison not controlled for multiplicity.|Regression, Logistic|||Placebo vs GSK189075 100 mg QD: Responders (\<7 mmol/L)||5.28|0.46|0.480
72431705|NCT00495469|144375416|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.87||||0.011|TWO_SIDED|95.0|1.44|16.46||Pairwise comparison not controlled for multiplicity.|Regression, Logistic|||Placebo vs GSK189075 250 mg QD: Responders (\<7 mmol/L)||16.46|1.44|0.011
72431706|NCT00495469|144375416|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.92||||0.087|TWO_SIDED|95.0|0.85|9.96||Pairwise comparison not controlled for multiplicity.|Regression, Logistic|||Placebo vs GSK189075 500 mg QD: Responders (\<7 mmol/L)||9.96|0.85|0.087
72431707|NCT00495469|144375416|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.92||||0.082|TWO_SIDED|95.0|0.87|9.78||Pairwise comparison not controlled for multiplicity.|Regression, Logistic|||Placebo vs GSK189075 1000 mg QD: Responders (\<7 mmol/L)||9.78|0.87|0.082
72431708|NCT00495469|144375416|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.0||||0.024|TWO_SIDED|95.0|1.2|13.27||Pairwise comparison not controlled for multiplicity.|Regression, Logistic|||Placebo vs GSK189075 250 mg BID: Responders (\<7 mmol/L)||13.27|1.20|0.024
72431709|NCT00495469|144375416|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.85||||0.012|TWO_SIDED|95.0|1.41|16.66||Pairwise comparison not controlled for multiplicity.|Regression, Logistic|||Placebo vs Pioglitazone 30 mg QD: Responders (\<7 mmol/L)||16.66|1.41|0.012
72431710|NCT00495469|144375416|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.85||||0.27|TWO_SIDED|95.0|0.62|5.54||Pairwise comparison not controlled for multiplicity.|Regression, Logistic|||Placebo vs GSK189075 100 mg QD: Responders (\<7.8 mmol/L)||5.54|0.62|0.270
72431711|NCT00495469|144375416|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.18||||0.043|TWO_SIDED|95.0|1.04|9.72||Pairwise comparison not controlled for multiplicity.|Regression, Logistic|||Placebo vs GSK189075 250 mg QD: Responders (\<7.8 mmol/L)||9.72|1.04|0.043
72431712|NCT00495469|144375416|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.17||||0.169|TWO_SIDED|95.0|0.72|6.53||Pairwise comparison not controlled for multiplicity.|Regression, Logistic|||Placebo vs GSK189075 500 mg QD: Responders (\<7.8 mmol/L)||6.53|0.72|0.169
72431713|NCT00495469|144375416|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.12||||0.042|TWO_SIDED|95.0|1.04|9.36||Pairwise comparison not controlled for multiplicity.|Regression, Logistic|||Placebo vs GSK189075 1000 mg QD: Responders (\<7.8 mmol/L)||9.36|1.04|0.042
72431714|NCT00495469|144375416|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.69||||0.02|TWO_SIDED|95.0|1.23|11.06||Pairwise comparison not controlled for multiplicity.|Regression, Logistic|||Placebo vs GSK189075 250 mg BID: Responders (\<7.8 mmol/L)||11.06|1.23|0.020
72431715|NCT00495469|144375416|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.04||||0.211|TWO_SIDED|95.0|0.67|6.24||Pairwise comparison not controlled for multiplicity.|Regression, Logistic|||Placebo vs Pioglitazone 30 mg QD: Responders (\<7.8 mmol/L)||6.24|0.67|0.211
72431716|NCT00495469|144375416|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.9||||0.179|TWO_SIDED|95.0|0.61|13.75||Pairwise comparison not controlled for multiplicity.|Regression, Logistic|||Placebo vs GSK189075 100 mg QD: Responders (reduction \>=1.7 mmol/L)||13.75|0.61|0.179
72431717|NCT00495469|144375416|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.93||||0.03|TWO_SIDED|95.0|1.17|20.87||Pairwise comparison not controlled for multiplicity.|Regression, Logistic|||Placebo vs GSK189075 250 mg QD: Responders (reduction \>=1.7 mmol/L)||20.87|1.17|0.030
72431718|NCT00495469|144375416|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.99||||0.142|TWO_SIDED|95.0|0.69|12.86||Pairwise comparison not controlled for multiplicity.|Regression, Logistic|||Placebo vs GSK189075 500 mg QD: Responders (reduction \>=1.7 mmol/L)||12.86|0.69|0.142
72431719|NCT00495469|144375416|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.21||||0.012|TWO_SIDED|95.0|1.49|25.83||Pairwise comparison not controlled for multiplicity.|Regression, Logistic|||Placebo vs GSK189075 1000 mg QD: Responders (reduction \>=1.7 mmol/L)||25.83|1.49|0.012
72431720|NCT00495469|144375416|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|13.01|||<|0.001|TWO_SIDED|95.0|3.14|54.0||Pairwise comparison not controlled for multiplicity.|Regression, Logistic|||Placebo vs GSK189075 250 mg BID: Responders (reduction \>=1.7 mmol/L)||54.00|3.14|<0.001
72431721|NCT00495469|144375416|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.6||||0.01|TWO_SIDED|95.0|1.56|27.99||Pairwise comparison not controlled for multiplicity.|Regression, Logistic|||Placebo vs Pioglitazone 30 mg QD: Responders (reduction \>=1.7 mmol/L)||27.99|1.56|0.010
72431722|NCT00495469|144375417|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.2||||0.318|TWO_SIDED|95.0|-0.19|0.59||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change = Baseline + Treatment||||0.59|-0.19|0.318
72365106|NCT03873116|144241836|SUPERIORITY||mixed-model repeated measures analysis|47.6||||0.005|TWO_SIDED|95.0|17.7|66.6|||mixed-model repeated measures analysis|||In the event that the first secondary endpoint did not meet statistical significance in the hierarchical testing scheme, testing of the second secondary endpoint of rate of expert-confirmed angioedema events during dosing in the effective treatment period for statistical significance would not be completed. Therefore, P-values reported are nominal.||66.6|17.7|0.005
72365107|NCT03873116|144241837|SUPERIORITY||mixed-model repeated measures analysis|-12.65||||0.213|TWO_SIDED|95.0|-33.33|8.03|||mixed-model repeated measures analysis|||Numerical difference in change from baseline of AE-QoL total score between treatment groups. In the event that the first secondary endpoint did not meet statistical significance in the hierarchical testing scheme, testing of the third secondary endpoint of change from baseline in AE-QoL total score at Week 24 for statistical significance would not be completed. P-values that are reported are nominal.||8.03|-33.33|0.213
72365108|NCT03873116|144241837|SUPERIORITY||mixed-model repeated measures analysis|-19.0||||0.061|TWO_SIDED|95.0|-39.0|0.99|||mixed-model repeated measures analysis|||Numerical difference in change from baseline of AE-QoL total score between treatment groups. In the event that the first secondary endpoint did not meet statistical significance in the hierarchical testing scheme, testing of the third secondary endpoint of change from baseline in AE-QoL total score at Week 24 for statistical significance would not be completed. P-values that are reported are nominal.||0.99|-39.00|0.061
72365109|NCT00912808|144241843|SUPERIORITY_OR_OTHER|||||||0.049||95.0|||||t-test, 2 sided|||Means and standard deviations were calculated to describe the subject baseline characteristics. Paired t-tests evaluated the difference between baseline and end of treatment frequency of falls. Changes post-treatment from baseline in secondary measures were also compared between the donepezil and placebo phases with paired t-tests or Wilcoxon signed rank tests when data was nonparametric. SPSS was used for the analysis.||||0.049
72365110|NCT00912808|144241844|SUPERIORITY_OR_OTHER|||||||0.27||95.0|||||t-test, 2 sided|||Means and standard deviations were calculated to describe the subject baseline characteristics. Paired t-tests evaluated the difference between baseline and end of treatment frequency of falls. Changes post-treatment from baseline in secondary measures were also compared between the donepezil and placebo phases with paired t-tests or Wilcoxon signed rank tests when data was nonparametric. SPSS was used for the analysis.||||0.27
72365111|NCT04109547|144242010|SUPERIORITY||Treatment difference|-1.5|||<|0.0001|TWO_SIDED|95.0|-1.8|-1.3||Unadjusted two-sided p-value for test of no difference from 0.|MMRM|||||-1.3|-1.8|<0.0001
72365112|NCT04109547|144242010|SUPERIORITY||Treatment difference|-1.4|||<|0.0001|TWO_SIDED|95.0|-1.6|-1.2||Unadjusted two-sided p-value for test of no difference from 0.|MMRM|||||-1.2|-1.6|<0.0001
72365113|NCT04109547|144242010|SUPERIORITY||Treatment difference|-1.0|||<|0.0001|TWO_SIDED|95.0|-1.2|-0.8||Unadjusted two-sided p-value for test of no difference from 0.|MMRM|||||-0.8|-1.2|<0.0001
72365114|NCT01656408|144242076|SUPERIORITY_OR_OTHER||Least Squares (LS) Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|3.8||0.978|TWO_SIDED|90.0|-6.4|6.6|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 1||6.6|-6.4|0.978
72365115|NCT01656408|144242076|SUPERIORITY_OR_OTHER||LS Mean Difference|-9.9|STANDARD_ERROR_OF_MEAN|3.2||0.005|TWO_SIDED|90.0|-15.4|-4.5|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 1||-4.5|-15.4|0.005
72365116|NCT01656408|144242076|SUPERIORITY_OR_OTHER||LS Mean Difference|-14.1|STANDARD_ERROR_OF_MEAN|3.3||0|TWO_SIDED|90.0|-19.8|-8.4|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 1||-8.4|-19.8|0.000
72365117|NCT01656408|144242076|SUPERIORITY_OR_OTHER||LS Mean Difference|-7.4|STANDARD_ERROR_OF_MEAN|3.2||0.03|TWO_SIDED|90.0|-13.0|-1.9|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 1||-1.9|-13.0|0.030
72365118|NCT01656408|144242076|SUPERIORITY_OR_OTHER||LS Mean Difference|3.5|STANDARD_ERROR_OF_MEAN|4.9||0.484|TWO_SIDED|90.0|-4.9|11.9|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 10||11.9|-4.9|0.484
72365119|NCT01656408|144242076|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.2|STANDARD_ERROR_OF_MEAN|3.0||0.169|TWO_SIDED|90.0|-9.3|0.9|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 10||0.9|-9.3|0.169
72365120|NCT01656408|144242076|SUPERIORITY_OR_OTHER||LS Mean Difference|-8.7|STANDARD_ERROR_OF_MEAN|3.6||0.023|TWO_SIDED|90.0|-14.9|-2.6|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 10||-2.6|-14.9|0.023
72365121|NCT01656408|144242076|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.4|STANDARD_ERROR_OF_MEAN|4.6||0.605|TWO_SIDED|90.0|-10.4|5.5|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 10||5.5|-10.4|0.605
72365122|NCT01656408|144242077|SUPERIORITY_OR_OTHER||LS Mean Difference|1.9|STANDARD_ERROR_OF_MEAN|3.9||0.635|TWO_SIDED|90.0|-4.9|8.7|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 1||8.7|-4.9|0.635
72365123|NCT01656408|144242077|SUPERIORITY_OR_OTHER||LS Mean Difference|-5.3|STANDARD_ERROR_OF_MEAN|2.8||0.077|TWO_SIDED|90.0|-10.1|-0.4|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 1||-0.4|-10.1|0.077
72365124|NCT01656408|144242077|SUPERIORITY_OR_OTHER||LS Mean Difference|-10.4|STANDARD_ERROR_OF_MEAN|2.7||0.001|TWO_SIDED|90.0|-15.0|-5.7|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 1||-5.7|-15.0|0.001
72365125|NCT01656408|144242077|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.1|STANDARD_ERROR_OF_MEAN|3.5||0.556|TWO_SIDED|90.0|-8.0|3.9|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 1||3.9|-8.0|0.556
72365126|NCT01656408|144242077|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.5|STANDARD_ERROR_OF_MEAN|2.3||0.527|TWO_SIDED|90.0|-5.5|2.5|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 10||2.5|-5.5|0.527
72365127|NCT01656408|144242077|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.4|STANDARD_ERROR_OF_MEAN|2.8||0.234|TWO_SIDED|90.0|-8.1|1.4|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 10||1.4|-8.1|0.234
72365128|NCT01656408|144242077|SUPERIORITY_OR_OTHER||LS Mean Difference|-8.4|STANDARD_ERROR_OF_MEAN|2.5||0.002|TWO_SIDED|90.0|-12.7|-4.1|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 10||-4.1|-12.7|0.002
72365129|NCT01656408|144242077|SUPERIORITY_OR_OTHER||LS Mean Difference|1.1|STANDARD_ERROR_OF_MEAN|3.1||0.726|TWO_SIDED|90.0|-4.2|6.5|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 10||6.5|-4.2|0.726
72365130|NCT01656408|144242078|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|4.5||0.855|TWO_SIDED|90.0|-9.0|7.3|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 1||7.3|-9.0|0.855
72365131|NCT01656408|144242078|SUPERIORITY_OR_OTHER||LS Mean Difference|3.7|STANDARD_ERROR_OF_MEAN|8.1||0.658|TWO_SIDED|90.0|-10.8|18.1|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 6||18.1|-10.8|0.658
72365132|NCT01656408|144242078|SUPERIORITY_OR_OTHER||LS Mean Difference|6.3|STANDARD_ERROR_OF_MEAN|7.1||0.392|TWO_SIDED|90.0|-6.3|18.9|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 15||18.9|-6.3|0.392
72365133|NCT01656408|144242079|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.5|STANDARD_ERROR_OF_MEAN|2.5||0.563|TWO_SIDED|90.0|-6.0|3.0|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 1||3.0|-6.0|0.563
72365134|NCT01656408|144242079|SUPERIORITY_OR_OTHER||LS Mean Difference|0.8|STANDARD_ERROR_OF_MEAN|0.9||0.381|TWO_SIDED|90.0|-0.8|2.5|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 6||2.5|-0.8|0.381
72365135|NCT01656408|144242079|SUPERIORITY_OR_OTHER||LS Mean Difference|1.8|STANDARD_ERROR_OF_MEAN|2.0||0.387|TWO_SIDED|90.0|-1.7|5.2|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 15||5.2|-1.7|0.387
72365136|NCT01656408|144242080|SUPERIORITY_OR_OTHER||LS Mean Difference|4.5|STANDARD_ERROR_OF_MEAN|4.7||0.357|TWO_SIDED|90.0|-3.9|12.8|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 1||12.8|-3.9|0.357
72365137|NCT01656408|144242080|SUPERIORITY_OR_OTHER||LS Mean Difference|7.4|STANDARD_ERROR_OF_MEAN|4.8||0.15|TWO_SIDED|90.0|-1.2|15.9|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 6||15.9|-1.2|0.150
72365138|NCT01656408|144242080|SUPERIORITY_OR_OTHER||LS Mean Difference|3.0|STANDARD_ERROR_OF_MEAN|5.2||0.578|TWO_SIDED|90.0|-6.3|12.3|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 15||12.3|-6.3|0.578
72365139|NCT01656408|144242081|SUPERIORITY_OR_OTHER||LS Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|3.0||0.942|TWO_SIDED|90.0|-5.1|5.5|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 1||5.5|-5.1|0.942
72365140|NCT01656408|144242081|SUPERIORITY_OR_OTHER||LS Mean Difference|1.9|STANDARD_ERROR_OF_MEAN|3.7||0.627|TWO_SIDED|90.0|-4.8|8.5|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 6||8.5|-4.8|0.627
72365141|NCT01656408|144242081|SUPERIORITY_OR_OTHER||LS Mean Difference|4.3|STANDARD_ERROR_OF_MEAN|1.9||0.046|TWO_SIDED|90.0|0.9|7.6|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 15||7.6|0.9|0.046
72365142|NCT01656408|144242082|SUPERIORITY_OR_OTHER||LS Mean Difference|-10.8|STANDARD_ERROR_OF_MEAN|3.8||0.025|TWO_SIDED|90.0|-18.0|-3.6|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 1||-3.6|-18.0|0.025
72365143|NCT01656408|144242082|SUPERIORITY_OR_OTHER||LS Mean Difference|-6.0|STANDARD_ERROR_OF_MEAN|2.6||0.055|TWO_SIDED|90.0|-11.0|-1.1|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 28||-1.1|-11.0|0.055
72365144|NCT01656408|144242083|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|2.6||0.999|TWO_SIDED|90.0|-4.4|4.4|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 1||4.4|-4.4|0.999
72365145|NCT01656408|144242083|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|3.2||0.934|TWO_SIDED|90.0|-5.7|5.2|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 8||5.2|-5.7|0.934
72365146|NCT01656408|144242083|SUPERIORITY_OR_OTHER||LS Mean Difference|2.1|STANDARD_ERROR_OF_MEAN|3.4||0.547|TWO_SIDED|90.0|-3.7|7.9|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 15||7.9|-3.7|0.547
72365147|NCT01656408|144242083|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|2.9||0.906|TWO_SIDED|90.0|-5.2|4.5|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 22||4.5|-5.2|0.906
72365148|NCT01656408|144242083|SUPERIORITY_OR_OTHER||LS Mean Difference|1.3|STANDARD_ERROR_OF_MEAN|3.1||0.682|TWO_SIDED|90.0|-4.0|6.6|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 28||6.6|-4.0|0.682
72365149|NCT01656408|144242084|SUPERIORITY_OR_OTHER||LS Mean Difference|-5.6|STANDARD_ERROR_OF_MEAN|2.8||0.099|TWO_SIDED|90.0|-11.1|0.0|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 1||0.0|-11.1|0.099
72365150|NCT01656408|144242084|SUPERIORITY_OR_OTHER||LS Mean Difference|-5.9|STANDARD_ERROR_OF_MEAN|2.1||0.034|TWO_SIDED|90.0|-10.1|-1.7|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 10||-1.7|-10.1|0.034
72365151|NCT01656408|144242085|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.4|STANDARD_ERROR_OF_MEAN|2.0||0.281|TWO_SIDED|90.0|-6.5|1.6|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 1||1.6|-6.5|0.281
72365152|NCT01656408|144242085|SUPERIORITY_OR_OTHER||LS Mean Difference|1.4|STANDARD_ERROR_OF_MEAN|1.3||0.333|TWO_SIDED|90.0|-1.2|4.0|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 10||4.0|-1.2|0.333
72365153|NCT01656408|144242086|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.8|STANDARD_ERROR_OF_MEAN|3.4||0.279|TWO_SIDED|90.0|-9.7|2.1|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 1||2.1|-9.7|0.279
72365154|NCT01656408|144242086|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|3.4||0.817|TWO_SIDED|90.0|-6.9|5.2|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 28||5.2|-6.9|0.817
72365155|NCT01656408|144242087|SUPERIORITY_OR_OTHER||LS Mean Difference|0.7|STANDARD_ERROR_OF_MEAN|2.4||0.756|TWO_SIDED|90.0|-3.2|4.7|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 1||4.7|-3.2|0.756
72365156|NCT01656408|144242087|SUPERIORITY_OR_OTHER||LS Mean Difference|3.9|STANDARD_ERROR_OF_MEAN|2.8||0.158|TWO_SIDED|90.0|-0.7|8.6|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 8||8.6|-0.7|0.158
72365157|NCT01656408|144242087|SUPERIORITY_OR_OTHER||LS Mean Difference|2.4|STANDARD_ERROR_OF_MEAN|2.8||0.404|TWO_SIDED|90.0|-2.4|7.1|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 15||7.1|-2.4|0.404
72365158|NCT01656408|144242087|SUPERIORITY_OR_OTHER||LS Mean Difference|3.0|STANDARD_ERROR_OF_MEAN|2.4||0.214|TWO_SIDED|90.0|-1.0|7.1|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 22||7.1|-1.0|0.214
72365159|NCT01656408|144242087|SUPERIORITY_OR_OTHER||LS Mean Difference|5.1|STANDARD_ERROR_OF_MEAN|2.9||0.086|TWO_SIDED|90.0|0.2|10.0|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 28||10.0|0.2|0.086
72365160|NCT01656408|144242088|SUPERIORITY_OR_OTHER||LS Mean Difference|-11.3|STANDARD_ERROR_OF_MEAN|3.1||0.003|TWO_SIDED|90.0|-16.8|-5.9|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 1||-5.9|-16.8|0.003
72365161|NCT01656408|144242088|SUPERIORITY_OR_OTHER||LS Mean Difference|-6.1|STANDARD_ERROR_OF_MEAN|3.5||0.105|TWO_SIDED|90.0|-12.3|0.1|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 28||0.1|-12.3|0.105
72365162|NCT01656408|144242089|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.4|STANDARD_ERROR_OF_MEAN|3.6||0.691|TWO_SIDED|90.0|-7.5|4.6|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 1||4.6|-7.5|0.691
72365163|NCT01656408|144242089|SUPERIORITY_OR_OTHER||LS Mean Difference|2.2|STANDARD_ERROR_OF_MEAN|3.9||0.57|TWO_SIDED|90.0|-4.3|8.8|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 8||8.8|-4.3|0.570
72365164|NCT01656408|144242089|SUPERIORITY_OR_OTHER||LS Mean Difference|1.5|STANDARD_ERROR_OF_MEAN|3.4||0.666|TWO_SIDED|90.0|-4.2|7.1|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 15||7.1|-4.2|0.666
72365165|NCT01656408|144242089|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.0|STANDARD_ERROR_OF_MEAN|4.7||0.534|TWO_SIDED|90.0|-10.9|4.9|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 22||4.9|-10.9|0.534
72365166|NCT01656408|144242089|SUPERIORITY_OR_OTHER||LS Mean Difference|2.5|STANDARD_ERROR_OF_MEAN|4.0||0.528|TWO_SIDED|90.0|-4.1|9.2|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 28||9.2|-4.1|0.528
72365167|NCT01656408|144242114|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|2.0||0.848|TWO_SIDED|90.0|-3.8|3.0|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 1||3.0|-3.8|0.848
72365168|NCT01656408|144242114|SUPERIORITY_OR_OTHER||LS Mean Difference|-6.0|STANDARD_ERROR_OF_MEAN|1.2|<|0.0001|TWO_SIDED|90.0|-8.0|-4.0|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 1||-4.0|-8.0|<0.0001
72365169|NCT01656408|144242114|SUPERIORITY_OR_OTHER||LS Mean Difference|-8.4|STANDARD_ERROR_OF_MEAN|3.5||0.025|TWO_SIDED|90.0|-14.4|-2.4|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 1||-2.4|-14.4|0.025
72365170|NCT01656408|144242114|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.9|STANDARD_ERROR_OF_MEAN|1.8||0.044|TWO_SIDED|90.0|-7.0|-0.8|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 1||-0.8|-7.0|0.044
72365171|NCT01656408|144242114|SUPERIORITY_OR_OTHER||LS Mean Difference|3.1|STANDARD_ERROR_OF_MEAN|2.0||0.139|TWO_SIDED|90.0|-0.4|6.6|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 10||6.6|-0.4|0.139
72365172|NCT01656408|144242114|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.5|STANDARD_ERROR_OF_MEAN|2.5||0.088|TWO_SIDED|90.0|-8.9|-0.2|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 10||-0.2|-8.9|0.088
72365173|NCT01656408|144242114|SUPERIORITY_OR_OTHER||LS Mean Difference|-5.5|STANDARD_ERROR_OF_MEAN|2.2||0.023|TWO_SIDED|90.0|-9.3|-1.6|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 10||-1.6|-9.3|0.023
72365174|NCT01656408|144242114|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|2.4||0.878|TWO_SIDED|90.0|-4.5|3.8|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 10||3.8|-4.5|0.878
72365175|NCT01656408|144242115|SUPERIORITY_OR_OTHER||LS Mean Difference|2.2|STANDARD_ERROR_OF_MEAN|3.2||0.512|TWO_SIDED|90.0|-3.4|7.7|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||7.7|-3.4|0.512
72365176|NCT01656408|144242115|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.4|STANDARD_ERROR_OF_MEAN|3.0||0.429|TWO_SIDED|90.0|-7.5|2.7|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||2.7|-7.5|0.429
72365177|NCT01656408|144242115|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.2|STANDARD_ERROR_OF_MEAN|2.9||0.166|TWO_SIDED|90.0|-9.3|0.8|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||0.8|-9.3|0.166
72365178|NCT01656408|144242115|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.1|STANDARD_ERROR_OF_MEAN|3.8||0.591|TWO_SIDED|90.0|-8.6|4.5|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||4.5|-8.6|0.591
72365179|NCT01656408|144242116|SUPERIORITY_OR_OTHER||LS Mean Difference|5.5|STANDARD_ERROR_OF_MEAN|4.7||0.248|TWO_SIDED|90.0|-2.5|13.5|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||13.5|-2.5|0.248
72365180|NCT01656408|144242116|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|2.9||0.836|TWO_SIDED|90.0|-5.6|4.4|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||4.4|-5.6|0.836
72365181|NCT01656408|144242116|SUPERIORITY_OR_OTHER||LS Mean Difference|-5.3|STANDARD_ERROR_OF_MEAN|3.2||0.109|TWO_SIDED|90.0|-10.7|0.1|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||0.1|-10.7|0.109
72365182|NCT01656408|144242116|SUPERIORITY_OR_OTHER||LS Mean Difference|1.0|STANDARD_ERROR_OF_MEAN|3.7||0.785|TWO_SIDED|90.0|-5.4|7.5|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||7.5|-5.4|0.785
72365183|NCT01656408|144242117|SUPERIORITY_OR_OTHER||LS Mean Difference|2.9|STANDARD_ERROR_OF_MEAN|3.2||0.365|TWO_SIDED|90.0|-2.5|8.3|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||8.3|-2.5|0.365
72365184|NCT01656408|144242117|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.4|STANDARD_ERROR_OF_MEAN|2.9||0.424|TWO_SIDED|90.0|-7.4|2.6|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||2.6|-7.4|0.424
72365185|NCT01656408|144242117|SUPERIORITY_OR_OTHER||LS Mean Difference|-7.8|STANDARD_ERROR_OF_MEAN|3.2||0.025|TWO_SIDED|90.0|-13.3|-2.2|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-2.2|-13.3|0.025
72365186|NCT01656408|144242117|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.2|STANDARD_ERROR_OF_MEAN|3.1||0.475|TWO_SIDED|90.0|-7.5|3.0|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||3.0|-7.5|0.475
72365187|NCT01656408|144242118|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.3|STANDARD_ERROR_OF_MEAN|3.4||0.715|TWO_SIDED|90.0|-7.4|4.8|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 1||4.8|-7.4|0.715
72365188|NCT01656408|144242118|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.3|STANDARD_ERROR_OF_MEAN|4.3||0.338|TWO_SIDED|90.0|-11.9|3.4|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 6||3.4|-11.9|0.338
72365189|NCT01656408|144242118|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.9|STANDARD_ERROR_OF_MEAN|3.4||0.281|TWO_SIDED|90.0|-10.0|2.3|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 15||2.3|-10.0|0.281
72365190|NCT01656408|144242119|SUPERIORITY_OR_OTHER||LS Mean Difference|2.9|STANDARD_ERROR_OF_MEAN|2.8||0.317|TWO_SIDED|90.0|-2.1|7.9|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||7.9|-2.1|0.317
72365191|NCT01656408|144242120|SUPERIORITY_OR_OTHER||LS Mean Difference|6.7|STANDARD_ERROR_OF_MEAN|3.6||0.09|TWO_SIDED|90.0|0.2|13.2|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||13.2|0.2|0.090
72365192|NCT01656408|144242121|SUPERIORITY_OR_OTHER||LS Mean Difference|3.3|STANDARD_ERROR_OF_MEAN|2.0||0.128|TWO_SIDED|90.0|-0.3|6.8|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||6.8|-0.3|0.128
72365193|NCT01656408|144242122|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.3|STANDARD_ERROR_OF_MEAN|3.1||0.477|TWO_SIDED|90.0|-7.9|3.3|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 1||3.3|-7.9|0.477
72365194|NCT01656408|144242122|SUPERIORITY_OR_OTHER||LS Mean Difference|-5.6|STANDARD_ERROR_OF_MEAN|3.0||0.09|TWO_SIDED|90.0|-11.0|-0.2|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 6||-0.2|-11.0|0.090
72365195|NCT01656408|144242122|SUPERIORITY_OR_OTHER||LS Mean Difference|-7.6|STANDARD_ERROR_OF_MEAN|3.0||0.028|TWO_SIDED|90.0|-13.0|-2.2|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 15||-2.2|-13.0|0.028
72365196|NCT01656408|144242123|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|2.5||0.877|TWO_SIDED|90.0|-4.9|4.1|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||4.1|-4.9|0.877
72365197|NCT01656408|144242124|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|4.6||0.827|TWO_SIDED|90.0|-9.3|7.2|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||7.2|-9.3|0.827
72365198|NCT01656408|144242125|SUPERIORITY_OR_OTHER||LS Mean Difference|-5.2|STANDARD_ERROR_OF_MEAN|3.5||0.161|TWO_SIDED|90.0|-11.4|1.0|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||1.0|-11.4|0.161
72365199|NCT01656408|144242126|SUPERIORITY_OR_OTHER||LS Mean Difference|-10.5|STANDARD_ERROR_OF_MEAN|4.4||0.046|TWO_SIDED|90.0|-18.8|-2.3|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 1||-2.3|-18.8|0.046
72365200|NCT01656408|144242126|SUPERIORITY_OR_OTHER||LS Mean Difference|-12.9|STANDARD_ERROR_OF_MEAN|2.3||0.001|TWO_SIDED|90.0|-17.2|-8.6|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 28||-8.6|-17.2|0.001
72365201|NCT01656408|144242127|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|2.6||0.91|TWO_SIDED|90.0|-4.6|5.2|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||5.2|-4.6|0.910
72365202|NCT01656408|144242128|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|3.6||0.906|TWO_SIDED|90.0|-6.6|5.7|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||5.7|-6.6|0.906
72365203|NCT01656408|144242129|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|2.4||0.87|TWO_SIDED|90.0|-4.4|3.7|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||3.7|-4.4|0.870
72365204|NCT01656408|144242130|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.3|STANDARD_ERROR_OF_MEAN|0.3|<|0.0001|TWO_SIDED|90.0|-5.0|-3.7|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 1||-3.7|-5.0|<0.0001
72365205|NCT01656408|144242130|SUPERIORITY_OR_OTHER||LS Mean Difference|-8.2|STANDARD_ERROR_OF_MEAN|1.2||0.001|TWO_SIDED|90.0|-10.7|-5.7|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 10||-5.7|-10.7|0.001
72365206|NCT01656408|144242131|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.8|STANDARD_ERROR_OF_MEAN|1.0||0.038|TWO_SIDED|90.0|-4.9|-0.8|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-0.8|-4.9|0.038
72365207|NCT01656408|144242132|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.4|STANDARD_ERROR_OF_MEAN|1.8||0.238|TWO_SIDED|90.0|-6.0|1.2|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||1.2|-6.0|0.238
72365208|NCT01656408|144242133|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.6|STANDARD_ERROR_OF_MEAN|1.0||0.048|TWO_SIDED|90.0|-4.7|-0.6|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-0.6|-4.7|0.048
72365209|NCT01656408|144242134|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|1.6||0.83|TWO_SIDED|90.0|-3.2|2.5|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 1||2.5|-3.2|0.830
72365210|NCT01656408|144242134|SUPERIORITY_OR_OTHER||LS Mean Difference|-5.8|STANDARD_ERROR_OF_MEAN|2.9||0.063|TWO_SIDED|90.0|-10.8|-0.7|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 28||-0.7|-10.8|0.063
72365211|NCT01656408|144242135|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|3.7||0.892|TWO_SIDED|90.0|-7.1|6.1|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||6.1|-7.1|0.892
72365212|NCT01656408|144242136|SUPERIORITY_OR_OTHER||LS Mean Difference|1.7|STANDARD_ERROR_OF_MEAN|3.1||0.571|TWO_SIDED|90.0|-3.4|6.9|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||6.9|-3.4|0.571
72365213|NCT01656408|144242137|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|2.8||0.816|TWO_SIDED|90.0|-5.4|4.0|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||4.0|-5.4|0.816
72365214|NCT01656408|144242138|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.5|STANDARD_ERROR_OF_MEAN|2.2||0.061|TWO_SIDED|90.0|-8.4|-0.6|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 1||-0.6|-8.4|0.061
72365215|NCT01656408|144242138|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.8|STANDARD_ERROR_OF_MEAN|2.6||0.161|TWO_SIDED|90.0|-8.3|0.7|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 28||0.7|-8.3|0.161
72365216|NCT01656408|144242139|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|2.0||0.786|TWO_SIDED|90.0|-4.0|2.9|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||2.9|-4.0|0.786
72365217|NCT01656408|144242140|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.8|STANDARD_ERROR_OF_MEAN|3.3||0.263|TWO_SIDED|90.0|-9.3|1.8|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||1.8|-9.3|0.263
72365218|NCT01656408|144242141|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|2.0||0.565|TWO_SIDED|90.0|-4.4|2.1|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||2.1|-4.4|0.565
72365219|NCT05465317|144242142|OTHER||Hazard Ratio (HR)|0.75|||<|0.001|TWO_SIDED|95.0|0.65|0.86|||Regression, Cox||Ratio calculated as Empagliflozin/DPP4i|Outcomes were assessed using Cox proportional hazards (PH) models in a 2-arm comparison. The analysis included all patients with a valid overlap weight and was performed using the reweighted population. The main analysis assessed outcomes while patients remain on initial treatment.||0.86|0.65|<0.001
72365220|NCT05465317|144242142|OTHER||Hazard Ratio (HR)|0.67||||0.001|TWO_SIDED|95.0|0.52|0.86|||Regression, Cox||Ratio calculated as Empagliflozin/DPP4i|Outcomes were assessed using Cox proportional hazards (PH) models in a 2-arm comparison. The analysis included all patients with a valid overlap weight and was performed using the reweighted population. The main analysis assessed outcomes while patients remain on initial treatment.||0.86|0.52|0.001
72365221|NCT05465317|144242142|OTHER||Hazard Ratio (HR)|0.79||||0.008|TWO_SIDED|95.0|0.67|0.94|||Regression, Cox||Ratio calculated as Empagliflozin/DPP4i|Outcomes were assessed using Cox proportional hazards (PH) models in a 2-arm comparison. The analysis included all patients with a valid overlap weight and was performed using the reweighted population. The main analysis assessed outcomes while patients remain on initial treatment.||0.94|0.67|0.008
72431723|NCT00495469|144375417|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.32||||0.131|TWO_SIDED|95.0|-0.73|0.1||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change = Baseline + Treatment||||0.10|-0.73|0.131
72365222|NCT05465317|144242143|OTHER||Hazard Ratio (HR)|0.74||||0.005|TWO_SIDED|95.0|0.6|0.91|||Regression, Cox||Ratio calculated as Empagliflozin/DPP4i|Outcomes were assessed using Cox proportional hazards (PH) models in a 2-arm comparison. The analysis included all patients with a valid overlap weight and was performed using the reweighted population. The main analysis assessed outcomes while patients remain on initial treatment.||0.91|0.60|0.005
72365223|NCT05465317|144242143|OTHER||Hazard Ratio (HR)|0.61||||0.02|TWO_SIDED|95.0|0.41|0.91|||Regression, Cox||Ratio calculated as Empagliflozin/DPP4i|Outcomes were assessed using Cox proportional hazards (PH) models in a 2-arm comparison. The analysis included all patients with a valid overlap weight and was performed using the reweighted population. The main analysis assessed outcomes while patients remain on initial treatment.||0.91|0.41|0.02
72365224|NCT05465317|144242143|OTHER||Hazard Ratio (HR)|0.8||||0.08|TWO_SIDED|95.0|0.63|1.03|||Regression, Cox||Ratio calculated as Empagliflozin/DPP4i|Outcomes were assessed using Cox proportional hazards (PH) models in a 2-arm comparison. The analysis included all patients with a valid overlap weight and was performed using the reweighted population. The main analysis assessed outcomes while patients remain on initial treatment.||1.03|0.63|0.08
72365225|NCT05465317|144242144|OTHER||Hazard Ratio (HR)|0.68||||0.05|TWO_SIDED|95.0|0.46|1.0|||Regression, Cox||Ratio calculated as Empagliflozin/DPP4i|Outcomes were assessed using Cox proportional hazards (PH) models in a 2-arm comparison. The analysis included all patients with a valid overlap weight and was performed using the reweighted population. The main analysis assessed outcomes while patients remain on initial treatment.||1.00|0.46|0.05
72365226|NCT05465317|144242144|OTHER||Hazard Ratio (HR)|0.61||||0.09|TWO_SIDED|95.0|0.35|1.09|||Regression, Cox||Ratio calculated as Empagliflozin/DPP4i|Outcomes were assessed using Cox proportional hazards (PH) models in a 2-arm comparison. The analysis included all patients with a valid overlap weight and was performed using the reweighted population. The main analysis assessed outcomes while patients remain on initial treatment.||1.09|0.35|0.09
72365227|NCT05465317|144242144|OTHER||Hazard Ratio (HR)|0.75||||0.3|TWO_SIDED|95.0|0.43|1.29|||Regression, Cox||Ratio calculated as Empagliflozin/DPP4i|Outcomes were assessed using Cox proportional hazards (PH) models in a 2-arm comparison. The analysis included all patients with a valid overlap weight and was performed using the reweighted population. The main analysis assessed outcomes while patients remain on initial treatment.||1.29|0.43|0.30
72365228|NCT05465317|144242145|OTHER||Hazard Ratio (HR)|0.73||||0.11|TWO_SIDED|95.0|0.49|1.08|||Regression, Cox||Ratio calculated as Empagliflozin/DPP4i|Outcomes were assessed using Cox proportional hazards (PH) models in a 2-arm comparison. The analysis included all patients with a valid overlap weight and was performed using the reweighted population. The main analysis assessed outcomes while patients remain on initial treatment.||1.08|0.49|0.11
72365229|NCT05465317|144242145|OTHER||Hazard Ratio (HR)|0.63||||0.12|TWO_SIDED|95.0|0.35|1.12|||Regression, Cox||Ratio calculated as Empagliflozin/DPP4i|Outcomes were assessed using Cox proportional hazards (PH) models in a 2-arm comparison. The analysis included all patients with a valid overlap weight and was performed using the reweighted population. The main analysis assessed outcomes while patients remain on initial treatment.||1.12|0.35|0.12
72365230|NCT05465317|144242145|OTHER||Hazard Ratio (HR)|0.84||||0.52|TWO_SIDED|95.0|0.5|1.42|||Regression, Cox||Ratio calculated as Empagliflozin/DPP4i|Outcomes were assessed using Cox proportional hazards (PH) models in a 2-arm comparison. The analysis included all patients with a valid overlap weight and was performed using the reweighted population. The main analysis assessed outcomes while patients remain on initial treatment.||1.42|0.50|0.52
72365231|NCT05465317|144242147|OTHER||Hazard Ratio (HR)|0.84||||0.02|TWO_SIDED|95.0|0.72|0.97|||Regression, Cox||Ratio calculated as Empagliflozin/DPP4i|Outcomes were assessed using Cox proportional hazards (PH) models in a 2-arm comparison. The analysis included all patients with a valid overlap weight and was performed using the reweighted population. The main analysis assessed outcomes while patients remain on initial treatment.||0.97|0.72|0.02
72365232|NCT05465317|144242147|OTHER||Hazard Ratio (HR)|0.82||||0.12|TWO_SIDED|95.0|0.65|1.05|||Regression, Cox||Ratio calculated as Empagliflozin/DPP4i|Outcomes were assessed using Cox proportional hazards (PH) models in a 2-arm comparison. The analysis included all patients with a valid overlap weight and was performed using the reweighted population. The main analysis assessed outcomes while patients remain on initial treatment.||1.05|0.65|0.12
72365233|NCT05465317|144242147|OTHER||Hazard Ratio (HR)|0.85||||0.1|TWO_SIDED|95.0|0.7|1.03|||Regression, Cox||Ratio calculated as Empagliflozin/DPP4i|Outcomes were assessed using Cox proportional hazards (PH) models in a 2-arm comparison. The analysis included all patients with a valid overlap weight and was performed using the reweighted population. The main analysis assessed outcomes while patients remain on initial treatment.||1.03|0.70|0.10
72365234|NCT05465317|144242148|OTHER||Hazard Ratio (HR)|0.9||||0.32|TWO_SIDED|95.0|0.72|1.11|||Regression, Cox||Ratio calculated as Empagliflozin/DPP4i|Outcomes were assessed using Cox proportional hazards (PH) models in a 2-arm comparison. The analysis included all patients with a valid overlap weight and was performed using the reweighted population. The main analysis assessed outcomes while patients remain on initial treatment.||1.11|0.72|0.32
72365235|NCT05465317|144242148|OTHER||Hazard Ratio (HR)|0.9||||0.5|TWO_SIDED|95.0|0.65|1.24|||Regression, Cox||Ratio calculated as Empagliflozin/DPP4i|Outcomes were assessed using Cox proportional hazards (PH) models in a 2-arm comparison. The analysis included all patients with a valid overlap weight and was performed using the reweighted population. The main analysis assessed outcomes while patients remain on initial treatment.||1.24|0.65|0.50
72365236|NCT05465317|144242148|OTHER||Hazard Ratio (HR)|0.91||||0.5|TWO_SIDED|95.0|0.68|1.2|||Regression, Cox||Ratio calculated as Empagliflozin/DPP4i|Outcomes were assessed using Cox proportional hazards (PH) models in a 2-arm comparison. The analysis included all patients with a valid overlap weight and was performed using the reweighted population. The main analysis assessed outcomes while patients remain on initial treatment.||1.20|0.68|0.50
72365237|NCT05465317|144242149|OTHER||Hazard Ratio (HR)|0.75||||0.005|TWO_SIDED|95.0|0.62|0.92|||Regression, Cox||Ratio calculated as Empagliflozin/DPP4i|Outcomes were assessed using Cox proportional hazards (PH) models in a 2-arm comparison. The analysis included all patients with a valid overlap weight and was performed using the reweighted population. The main analysis assessed outcomes while patients remain on initial treatment.||0.92|0.62|0.005
72431724|NCT00495469|144375417|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.15||||0.452|TWO_SIDED|95.0|-0.54|0.24||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change = Baseline + Treatment||||0.24|-0.54|0.452
72365238|NCT05465317|144242149|OTHER||Hazard Ratio (HR)|0.69||||0.03|TWO_SIDED|95.0|0.49|0.96|||Regression, Cox||Ratio calculated as Empagliflozin/DPP4i|Outcomes were assessed using Cox proportional hazards (PH) models in a 2-arm comparison. The analysis included all patients with a valid overlap weight and was performed using the reweighted population. The main analysis assessed outcomes while patients remain on initial treatment.||0.96|0.49|0.03
72365239|NCT05465317|144242149|OTHER||Hazard Ratio (HR)|0.8||||0.074|TWO_SIDED|95.0|0.63|1.02|||Regression, Cox||Ratio calculated as Empagliflozin/DPP4i|Outcomes were assessed using Cox proportional hazards (PH) models in a 2-arm comparison. The analysis included all patients with a valid overlap weight and was performed using the reweighted population. The main analysis assessed outcomes while patients remain on initial treatment.||1.02|0.63|0.074
72365240|NCT05465317|144242150|OTHER||Hazard Ratio (HR)|1.03||||0.46|TWO_SIDED|95.0|0.95|1.12|||Regression, Cox||Ratio calculated as Empagliflozin/DPP4i|Outcomes were assessed using Cox proportional hazards (PH) models in a 2-arm comparison. The analysis included all patients with a valid overlap weight and was performed using the reweighted population. The main analysis assessed outcomes while patients remain on initial treatment.||1.12|0.95|0.46
72365241|NCT05465317|144242150|OTHER||Hazard Ratio (HR)|1.04||||0.63|TWO_SIDED|95.0|0.9|1.2|||Regression, Cox||Ratio calculated as Empagliflozin/DPP4i|Outcomes were assessed using Cox proportional hazards (PH) models in a 2-arm comparison. The analysis included all patients with a valid overlap weight and was performed using the reweighted population. The main analysis assessed outcomes while patients remain on initial treatment.||1.20|0.90|0.63
72365242|NCT05465317|144242150|OTHER||Hazard Ratio (HR)|1.03||||0.52|TWO_SIDED|95.0|0.94|1.14|||Regression, Cox||Ratio calculated as Empagliflozin/DPP4i|Outcomes were assessed using Cox proportional hazards (PH) models in a 2-arm comparison. The analysis included all patients with a valid overlap weight and was performed using the reweighted population. The main analysis assessed outcomes while patients remain on initial treatment.||1.14|0.94|0.52
72365243|NCT05465317|144242151|OTHER||Hazard Ratio (HR)|0.81||||0.007|TWO_SIDED|95.0|0.7|0.94|||Regression, Cox||Ratio calculated as Empagliflozin/DPP4i|Outcomes were assessed using Cox proportional hazards (PH) models in a 2-arm comparison. The analysis included all patients with a valid overlap weight and was performed using the reweighted population. The main analysis assessed outcomes while patients remain on initial treatment.||0.94|0.70|0.007
72365244|NCT05465317|144242151|OTHER||Hazard Ratio (HR)|0.74||||0.03|TWO_SIDED|95.0|0.57|0.97|||Regression, Cox||Ratio calculated as Empagliflozin/DPP4i|Outcomes were assessed using Cox proportional hazards (PH) models in a 2-arm comparison. The analysis included all patients with a valid overlap weight and was performed using the reweighted population. The main analysis assessed outcomes while patients remain on initial treatment.||0.97|0.57|0.03
72365245|NCT05465317|144242151|OTHER||Hazard Ratio (HR)|0.85||||0.1|TWO_SIDED|95.0|0.71|1.03|||Regression, Cox||Ratio calculated as Empagliflozin/DPP4i|Outcomes were assessed using Cox proportional hazards (PH) models in a 2-arm comparison. The analysis included all patients with a valid overlap weight and was performed using the reweighted population. The main analysis assessed outcomes while patients remain on initial treatment.||1.03|0.71|0.10
72365246|NCT05465317|144242152|OTHER||Hazard Ratio (HR)|1.37||||0.15|TWO_SIDED|95.0|0.89|2.1|||Regression, Cox||Ratio calculated as Empagliflozin/DPP4i|Outcomes were assessed using Cox proportional hazards (PH) models in a 2-arm comparison. The analysis included all patients with a valid overlap weight and was performed using the reweighted population. The main analysis assessed outcomes while patients remain on initial treatment.||2.10|0.89|0.15
72365247|NCT05465317|144242152|OTHER||Hazard Ratio (HR)|1.05||||0.93|TWO_SIDED|95.0|0.4|2.72|||Regression, Cox||Ratio calculated as Empagliflozin/DPP4i|Outcomes were assessed using Cox proportional hazards (PH) models in a 2-arm comparison. The analysis included all patients with a valid overlap weight and was performed using the reweighted population. The main analysis assessed outcomes while patients remain on initial treatment.||2.72|0.40|0.93
72365248|NCT05465317|144242152|OTHER||Hazard Ratio (HR)|1.47||||0.113|TWO_SIDED|95.0|0.91|2.38|||Regression, Cox||Ratio calculated as Empagliflozin/DPP4i|Outcomes were assessed using Cox proportional hazards (PH) models in a 2-arm comparison. The analysis included all patients with a valid overlap weight and was performed using the reweighted population. The main analysis assessed outcomes while patients remain on initial treatment.||2.38|0.91|0.113
72365249|NCT05465317|144242153|OTHER||Hazard Ratio (HR)|0.9||||0.43|TWO_SIDED|95.0|0.71|1.16|||Regression, Cox||Ratio calculated as Empagliflozin/DPP4i|Outcomes were assessed using Cox proportional hazards (PH) models in a 2-arm comparison. The analysis included all patients with a valid overlap weight and was performed using the reweighted population. The main analysis assessed outcomes while patients remain on initial treatment.||1.16|0.71|0.43
72365250|NCT05465317|144242153|OTHER||Hazard Ratio (HR)|0.8||||0.32|TWO_SIDED|95.0|0.51|1.24|||Regression, Cox||Ratio calculated as Empagliflozin/DPP4i|Outcomes were assessed using Cox proportional hazards (PH) models in a 2-arm comparison. The analysis included all patients with a valid overlap weight and was performed using the reweighted population. The main analysis assessed outcomes while patients remain on initial treatment.||1.24|0.51|0.32
72365251|NCT05465317|144242153|OTHER||Hazard Ratio (HR)|0.96||||0.81|TWO_SIDED|95.0|0.71|1.3|||Regression, Cox||Ratio calculated as Empagliflozin/DPP4i|Outcomes were assessed using Cox proportional hazards (PH) models in a 2-arm comparison. The analysis included all patients with a valid overlap weight and was performed using the reweighted population. The main analysis assessed outcomes while patients remain on initial treatment.||1.30|0.71|0.81
72365252|NCT05465317|144242154|OTHER||Hazard Ratio (HR)|0.93||||0.69|TWO_SIDED|95.0|0.65|1.33|||Regression, Cox||Ratio calculated as Empagliflozin/DPP4i|Outcomes were assessed using Cox proportional hazards (PH) models in a 2-arm comparison. The analysis included all patients with a valid overlap weight and was performed using the reweighted population. The main analysis assessed outcomes while patients remain on initial treatment.||1.33|0.65|0.69
72365253|NCT05465317|144242154|OTHER||Hazard Ratio (HR)|0.93||||0.82|TWO_SIDED|95.0|0.51|1.7|||Regression, Cox||Ratio calculated as Empagliflozin/DPP4i|Outcomes were assessed using Cox proportional hazards (PH) models in a 2-arm comparison. The analysis included all patients with a valid overlap weight and was performed using the reweighted population. The main analysis assessed outcomes while patients remain on initial treatment.||1.70|0.51|0.82
72431725|NCT00495469|144375417|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.04||||0.845|TWO_SIDED|95.0|-0.44|0.36||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change = Baseline + Treatment||||0.36|-0.44|0.845
72365254|NCT05465317|144242154|OTHER||Hazard Ratio (HR)|0.93||||0.76|TWO_SIDED|95.0|0.6|1.45|||Regression, Cox||Ratio calculated as Empagliflozin/DPP4i|Outcomes were assessed using Cox proportional hazards (PH) models in a 2-arm comparison. The analysis included all patients with a valid overlap weight and was performed using the reweighted population. The main analysis assessed outcomes while patients remain on initial treatment.||1.45|0.60|0.76
72365255|NCT05465317|144242155|OTHER||Hazard Ratio (HR)|0.68||||0.39|TWO_SIDED|95.0|0.29|1.62|||Regression, Cox||Ratio calculated as Empagliflozin/DPP4i|Outcomes were assessed using Cox proportional hazards (PH) models in a 2-arm comparison. The analysis included all patients with a valid overlap weight and was performed using the reweighted population. The main analysis assessed outcomes while patients remain on initial treatment.||1.62|0.29|0.39
72365256|NCT05465317|144242155|OTHER||Hazard Ratio (HR)|0.46||||0.34|TWO_SIDED|95.0|0.09|2.27|||Regression, Cox||Ratio calculated as Empagliflozin/DPP4i|Outcomes were assessed using Cox proportional hazards (PH) models in a 2-arm comparison. The analysis included all patients with a valid overlap weight and was performed using the reweighted population. The main analysis assessed outcomes while patients remain on initial treatment.||2.27|0.09|0.34
72365257|NCT05465317|144242155|OTHER||Hazard Ratio (HR)|0.82||||0.72|TWO_SIDED|95.0|0.29|2.33|||Regression, Cox||Ratio calculated as Empagliflozin/DPP4i|Outcomes were assessed using Cox proportional hazards (PH) models in a 2-arm comparison. The analysis included all patients with a valid overlap weight and was performed using the reweighted population. The main analysis assessed outcomes while patients remain on initial treatment.||2.33|0.29|0.72
72365258|NCT05465317|144242156|OTHER||Hazard Ratio (HR)|0.84||||0.62|TWO_SIDED|95.0|0.43|1.66|||Regression, Cox||Ratio calculated as Empagliflozin/DPP4i|Outcomes were assessed using Cox proportional hazards (PH) models in a 2-arm comparison. The analysis included all patients with a valid overlap weight and was performed using the reweighted population. The main analysis assessed outcomes while patients remain on initial treatment.||1.66|0.43|0.62
72365259|NCT05465317|144242156|OTHER||Hazard Ratio (HR)|0.59||||0.31|TWO_SIDED|95.0|0.21|1.64|||Regression, Cox||Ratio calculated as Empagliflozin/DPP4i|Outcomes were assessed using Cox proportional hazards (PH) models in a 2-arm comparison. The analysis included all patients with a valid overlap weight and was performed using the reweighted population. The main analysis assessed outcomes while patients remain on initial treatment.||1.64|0.21|0.31
72365260|NCT05465317|144242156|OTHER||Hazard Ratio (HR)|1.16||||0.76|TWO_SIDED|95.0|0.46|2.92|||Regression, Cox||Ratio calculated as Empagliflozin/DPP4i|Outcomes were assessed using Cox proportional hazards (PH) models in a 2-arm comparison. The analysis included all patients with a valid overlap weight and was performed using the reweighted population. The main analysis assessed outcomes while patients remain on initial treatment.||2.92|0.46|0.76
72365261|NCT05465317|144242157|OTHER||Hazard Ratio (HR)|1.72|||<|0.001|TWO_SIDED|95.0|1.58|1.88|||Regression, Cox||Ratio calculated as Empagliflozin/DPP4i|Outcomes were assessed using Cox proportional hazards (PH) models in a 2-arm comparison. The analysis included all patients with a valid overlap weight and was performed using the reweighted population. The main analysis assessed outcomes while patients remain on initial treatment.||1.88|1.58|<0.001
72365262|NCT05465317|144242157|OTHER||Hazard Ratio (HR)|1.84|||<|0.001|TWO_SIDED|95.0|1.48|2.3|||Regression, Cox||Ratio calculated as Empagliflozin/DPP4i|Outcomes were assessed using Cox proportional hazards (PH) models in a 2-arm comparison. The analysis included all patients with a valid overlap weight and was performed using the reweighted population. The main analysis assessed outcomes while patients remain on initial treatment.||2.30|1.48|<0.001
72365263|NCT05465317|144242157|OTHER||Hazard Ratio (HR)|1.7|||<|0.001|TWO_SIDED|95.0|1.54|1.87|||Regression, Cox||Ratio calculated as Empagliflozin/DPP4i|Outcomes were assessed using Cox proportional hazards (PH) models in a 2-arm comparison. The analysis included all patients with a valid overlap weight and was performed using the reweighted population. The main analysis assessed outcomes while patients remain on initial treatment.||1.87|1.54|<0.001
72365264|NCT03592186|144242175|SUPERIORITY|In zero-inflated distributions, two outcomes can be specified: 1) probability of being an excess zero (falling outside expected negative binomial distribution), and 2) count value, if not an excess zero. Our focal effect of interest was Time\*Condition in the count distribution, i.e. effect of condition over time on predicting the percent of days used greater than zero.|Risk Ratio (RR)|1.15|STANDARD_ERROR_OF_MEAN|2.57||0.12|TWO_SIDED|95.0|0.97|1.36|||Mixed Models Analysis|||Mixed models with zero-inflated distributions evaluated whether there was a Time\*Condition interaction, using data from the baseline, 12-week, and 24-week assessments. Full maximum likelihood estimation was used. We tested the primary outcome (percent of days of use over the past 90 days, adjusted for time in a controlled environment) for overall number of days of use.||1.36|.97|.12
72365265|NCT03592186|144242176|SUPERIORITY||Risk Ratio (RR)|-0.1|STANDARD_ERROR_OF_MEAN|0.34||0.19|TWO_SIDED|95.0|-0.34|0.07|||Mixed Models Analysis|||Mixed models using a linear distribution evaluated whether change in substance-related problems differed by condition. The focal effect was a Time\*Condition interaction, using data from the baseline, 12-week, and 24-week assessments. Full maximum likelihood estimation was used.||.07|-.34|.19
72365266|NCT03592186|144242177|SUPERIORITY||Chi-square value|0.01||||0.92|TWO_SIDED||||||Chi-squared|||Comparison of the count of positive urine screens by condition at 12 weeks||||.92
72365267|NCT00198822|144242193|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.65||||0.05|ONE_SIDED|95.0||0.99||We set an a priori level of statistical significance of p equal to 0.05.|generalized estimating equations|RR with 95% CIs were estimated by GEE binomial regression, with a log link function and exchangeable correlation appropriate for binary data.|The vitamin A group and the Beta-carotene group were compared to the placebo group.|Sample size was based on an expected placebo group MR of 600/100,000 pregnancies, requiring 18,000 pregnancies to detect a 35% reduction in all-cause mortality, with a 5% type I error, 80% power, 1.21 design effect, 15% early pregnancy loss and 10% loss to follow-up. A mid-study DSMB analysis suggested a lower MR, leading the SS to be increased to 67,740. However, with no mortality difference evident at a DSMB meeting in Dec 2006, the trial was halted leaving 59,721 in the trial cohort.||0.99||0.05
72365268|NCT02072668|144242201|SUPERIORITY|||||||0.6281|||||||Student t-test followed by ANOVA|Student t-test subsequently followed by crossover ANOVA model testing carry-over effect and treatment effect||||||0.6281
72431726|NCT00495469|144375417|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.18||||0.393|TWO_SIDED|95.0|-0.58|0.23||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change = Baseline + Treatment||||0.23|-0.58|0.393
72365269|NCT02072668|144242202|SUPERIORITY|||||||0.7973|||||||Student t-test followed by ANOVA|Student t-test subsequently followed by crossover ANOVA model testing carry-over effect and treatment effect||||||0.7973
72365270|NCT02072668|144242203|SUPERIORITY|||||||0.4442|||||||Student t-test followed by ANOVA|Student t-test subsequently followed by crossover ANOVA model testing carry-over effect and treatment effect||||||0.4442
72365271|NCT02072668|144242204|SUPERIORITY|||||||0.2545|||||||Student t-test followed by ANOVA|Student t-test subsequently followed by crossover ANOVA model testing carry-over effect and treatment effect||||||0.2545
72365272|NCT02072668|144242210|SUPERIORITY|||||||0.4374|||||||Student t-test followed by ANOVA|Student t-test subsequently followed by crossover ANOVA model testing carry-over effect and treatment effect||||||0.4374
72365273|NCT02072668|144242211|SUPERIORITY|||||||0.347|||||||Student t-test followed by ANOVA|Student t-test subsequently followed by crossover ANOVA model testing carry-over effect and treatment effect||||||0.3470
72365274|NCT02072668|144242212|SUPERIORITY|||||||0.0755|||||||Student t-test followed by ANOVA|Student t-test subsequently followed by crossover ANOVA model testing carry-over effect and treatment effect||||||0.0755
72365275|NCT02072668|144242214|SUPERIORITY|||||||0.0708|||||||Student t-test followed by ANOVA|Student t-test subsequently followed by crossover ANOVA model testing carry-over effect and treatment effect||||||0.0708
72365276|NCT02072668|144242215|SUPERIORITY|||||||0.4501|||||||Student t-test followed by ANOVA|Student t-test subsequently followed by crossover ANOVA model testing carry-over effect and treatment effect||||||0.4501
72365277|NCT02072668|144242216|SUPERIORITY|||||||0.0767|||||||Student t-test followed by ANOVA|Student t-test subsequently followed by crossover ANOVA model testing carry-over effect and treatment effect||||||0.0767
72365278|NCT02072668|144242217|SUPERIORITY|||||||0.725|||||||Student t-test followed by ANOVA|Student t-test subsequently followed by crossover ANOVA model testing carry-over effect and treatment effect||||||0.7250
72365279|NCT00554216|144242239|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.36|STANDARD_ERROR_OF_MEAN|0.476|<|0.0001|TWO_SIDED|95.0|8.43|10.3||Intersection-union method applied in a step-down testing approach|ANCOVA|||With at least 250 subjects in each of the 3 arms in this trial, the trial has more than 90% power to detect a difference of at least 3.1% between combination and placebo treatment assuming a standard deviation of 5.3% and a significance level of 0.05.||10.30|8.43|<0.0001
72365280|NCT00554216|144242239|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.54|STANDARD_ERROR_OF_MEAN|0.596|<|0.0001|TWO_SIDED|95.0|2.38|4.71||Intersection-union method applied in a step-down testing approach|ANCOVA|||With at least 250 subjects in each of the 3 arms in this trial, the trial has more than 90% power to detect a difference of at least 3.1% between combination and placebo treatment assuming a standard deviation of 5.3% and a significance level of 0.05.||4.71|2.38|<0.0001
72365281|NCT00554216|144242239|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.82|STANDARD_ERROR_OF_MEAN|0.596|<|0.0001|TWO_SIDED|95.0|4.65|6.99||Intersection-union method applied in a step-down testing approach|ANCOVA|||With at least 250 subjects in each of the 3 arms in this trial, the trial has more than 90% power to detect a difference of at least 3.1% between combination and placebo treatment assuming a standard deviation of 5.3% and a significance level of 0.05.||6.99|4.65|<0.0001
72365282|NCT00554216|144242240|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|9.61|STANDARD_ERROR_OF_MEAN|1.463|<|0.0001|TWO_SIDED|95.0|7.13|12.95||Intersection-union method applied in a step-down testing approach|Regression, Logistic|||With at least 250 subjects in each of the 3 arms in this trial, the trial has more than 90% power to detect a difference of at least 3.1% between combination and placebo treatment assuming a standard deviation of 5.3% and a significance level of 0.05.||12.95|7.13|<0.0001
72365283|NCT00554216|144242240|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.97|STANDARD_ERROR_OF_MEAN|0.706|<|0.0001|TWO_SIDED|95.0|2.8|5.63||Intersection-union method applied in a step-down testing approach|Regression, Logistic|||With at least 250 subjects in each of the 3 arms in this trial, the trial has more than 90% power to detect a difference of at least 3.1% between combination and placebo treatment assuming a standard deviation of 5.3% and a significance level of 0.05.||5.63|2.80|<0.0001
72365284|NCT00554216|144242240|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.42|STANDARD_ERROR_OF_MEAN|0.394|<|0.0001|TWO_SIDED|95.0|1.76|3.33||Intersection-union method applied in a step-down testing approach|Regression, Logistic|||With at least 250 subjects in each of the 3 arms in this trial, the trial has more than 90% power to detect a difference of at least 3.1% between combination and placebo treatment assuming a standard deviation of 5.3% and a significance level of 0.05.||3.33|1.76|<0.0001
72365285|NCT02930824|144242247|SUPERIORITY|We will test the hypothesis that CYP2C19 rapid metabolizers or ultra rapid metabolizers (1 or 2 gain-of-function alleles) in the genotype-supported arm have better gastroesophageal reflux disease and symptom control than CYP2C19 rapid metabolizers or ultra rapid metabolizers in the conventional treatment group because they will have their dose increased based on their genotype.||||||0.78||||||Analysis was done of adult patients enrolled that have a CYP2C19 Rapid or Ultra-rapid metabolizer result.|t-test, 2 sided|||We will test the hypothesis that CYP2C19 rapid metabolizers or ultra rapid metabolizers (1 or 2 gain-of-function alleles) in the genotype-supported arm have better gastroesophageal reflux disease and symptom control than CYP2C19 rapid metabolizers or ultra rapid metabolizers in the conventional treatment group because they will have their dose increased based on their genotype.||||0.78
72431727|NCT00495469|144375417|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.36||||0.072|TWO_SIDED|95.0|-0.76|0.03||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change = Baseline + Treatment||||0.03|-0.76|0.072
72365286|NCT02930824|144242248|SUPERIORITY|||||||0.031||||||Adjusted for baseline score, race, baseline proton pump inhibitor use, baseline histamine receptor antagonist use. A sensitivity analysis of participants only on omeprazole revealed similar findings.|Wilcoxon (Mann-Whitney)|Adjusted these end points for covariates, including the baseline score, race, and baseline medications using logistic regression||||||0.031
72365287|NCT02930824|144242249|SUPERIORITY||Hazard Ratio (HR)|2.42||||0.07|TWO_SIDED|95.0|0.9|6.3||unadjusted|Log Rank|||||6.3|0.9|0.07
72365288|NCT02930824|144242250|SUPERIORITY|||||||0.97||||||If a participant did not complete a follow-up questionnaire during their third to fifth week of proton pump inhibitor therapy, their questionnaire results were excluded from the analyses.|Wilcoxon (Mann-Whitney)|||If a participant did not complete a follow-up questionnaire during their third to fifth week of proton pump inhibitor therapy, their questionnaire results were excluded from the analyses.||||0.97
72365289|NCT02930824|144242251|SUPERIORITY|||||||0.83|||||||Wilcoxon (Mann-Whitney)|||If a participant did not complete a follow-up questionnaire during their third to fifth week of proton pump inhibitor therapy, their questionnaire results were excluded from the analyses.||||0.83
72365290|NCT02540629|144242265|EQUIVALENCE|Chi-squared test||||||0.01|||||||Chi-squared|||||||0.01
72365291|NCT01524796|144242300|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||paired Wilcoxon signed-rank test|||||||<0.001
72365292|NCT01524796|144242301|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Wilcoxon signed-rank test|||||||<0.001
72365293|NCT01524796|144242302|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Wilcoxon signed-rank test|||||||<0.001
72365294|NCT01907854|144242320|SUPERIORITY_OR_OTHER||Treatment difference|-0.61|||<|0.0001|TWO_SIDED|95.0|-0.82|-0.4|||Mixed Models Analysis|Superiority of liraglutide over sitagliptin was concluded if the 95% Confidence Interval for the treatment difference was entirely below 0%.||Changes in HbA1c from baseline to the 26 weeks measurements were analysed using MMRM, with treatment, baseline HbA1c level (≤8.5% and \>8.5%), metformin dose (\<1500 mg/day and ≥1500 mg/day), the interaction between baseline HbA1c level and metformin dose, and country as factors and the HbA1c value at baseline as a covariate, all variables nested within week as a factor.||-0.40|-0.82|<0.0001
72365295|NCT01907854|144242321|SUPERIORITY_OR_OTHER||Treatment difference|-1.67|||<|0.0001|TWO_SIDED|95.0|-2.34|-0.99|||Mixed Models Analysis|Superiority of liraglutide over sitagliptin was concluded if the 95% Confidence Interval for the treatment difference was entirely below 0%.||Change in body weight from baseline to the 26 weeks measurements was analysed using MMRM, with treatment, baseline HbA1c level (≤8.5% and \>8.5%), metformin dose (\<1500 mg/day and ≥1500 mg/day), the interaction between baseline HbA1c level and metformin dose, and country as factors and the body weight at baseline as a covariate and all variables nested within week as a factor.||-0.99|-2.34|<0.0001
72365296|NCT02215252|144242328|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.41|STANDARD_DEVIATION|0.355|||TWO_SIDED|90.0|-1.0|0.17||||||Statistical analysis is only for week 4. Mixed Models Repeated Measures analysis including all data up to Week 4 ,incorporating Bayesian priors separately on the placebo response and pregabalin effect.||0.17|-1.00|
72365297|NCT02215252|144242328|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.53|STANDARD_DEVIATION|0.23|||TWO_SIDED|90.0|-0.91|-0.2||||||Statistical analysis is only for week 4. Mixed Models Repeated Measures analysis including all data up to Week 4 ,incorporating Bayesian priors separately on the placebo response and pregabalin effect.||-0.20|-0.91|
72365298|NCT02215252|144242329|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.91|||||TWO_SIDED|90.0|0.78|4.69||||||Statistical analysis is only for Week 4. Logistic Regression using all data up to Week 4.||4.69|0.78|
72365299|NCT02215252|144242329|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.63|||||TWO_SIDED|90.0|1.06|6.56||||||Statistical analysis is only for Week 4. Logistic Regression using all data up to Week 4.||6.56|1.06|
72365300|NCT02215252|144242330|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.25|||||TWO_SIDED|90.0|0.33|4.74||||||Statistical analysis is only for Week 4. Logistic Regression using all data up to Week 4.||4.74|0.33|
72365301|NCT02215252|144242330|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.75|||||TWO_SIDED|90.0|1.43|15.81||||||Statistical analysis is only for Week 4. Logistic Regression using all data up to Week 4.||15.81|1.43|
72365302|NCT02215252|144242331|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.04|STANDARD_ERROR_OF_MEAN|0.43|||TWO_SIDED|90.0|-1.75|-0.32||||||Statistical analysis is only for Week 4. Mixed Models Repeated Measures analysis including all data up to Week 4.||-0.32|-1.75|
72365303|NCT02215252|144242331|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.69|STANDARD_ERROR_OF_MEAN|0.44|||TWO_SIDED|90.0|-1.43|0.04||||||Statistical analysis is only for Week 4. Mixed Models Repeated Measures analysis including all data up to Week 4||0.04|-1.43|
72365304|NCT02215252|144242332|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.22|STANDARD_ERROR_OF_MEAN|0.39|||TWO_SIDED|90.0|-0.86|0.43||||||Statistical analysis is only for Week 4. Mixed Models Repeated Measures analysis including all data up to Week 4||0.43|-0.86|
72365305|NCT02215252|144242332|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.66|STANDARD_ERROR_OF_MEAN|0.4|||TWO_SIDED|90.0|-1.33|0.0||||||Statistical analysis is only for Week 4. Mixed Models Repeated Measures analysis including all data up to Week 4||0.00|-1.33|
72365306|NCT02215252|144242333|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.46|||TWO_SIDED|90.0|-0.87|0.67||||||Statistical analysis is only for Week 4. Mixed Models Repeated Measures analysis including all data up to Week 4.||0.67|-0.87|
72365307|NCT02215252|144242333|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.58|STANDARD_ERROR_OF_MEAN|0.47|||TWO_SIDED|90.0|-1.36|0.2||||||Statistical analysis is only for Week 4. Mixed Models Repeated Measures analysis including all data up to Week 4.||0.20|-1.36|
72365308|NCT02215252|144242334|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.09|STANDARD_ERROR_OF_MEAN|0.35|||TWO_SIDED|90.0|-0.49|0.67||||||Statistical analysis is only for Week 4. Mixed Models Repeated Measures analysis including all data up to Week 4.||0.67|-0.49|
72365309|NCT02215252|144242334|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.46|STANDARD_ERROR_OF_MEAN|0.36|||TWO_SIDED|90.0|-1.05|0.13||||||Statistical analysis is only for Week 4. Mixed Models Repeated Measures analysis including all data up to Week 4.||0.13|-1.05|
72365310|NCT02215252|144242335|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.35|STANDARD_ERROR_OF_MEAN|0.45|||TWO_SIDED|90.0|-1.09|0.39||||||Statistical analysis is only for Week 4. Mixed Models Repeated Measures analysis including all data up to Week 4.||0.39|-1.09|
72365311|NCT02215252|144242335|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.24|STANDARD_ERROR_OF_MEAN|0.45|||TWO_SIDED|90.0|-1.0|0.51||||||Statistical analysis is only for Week 4. Mixed Models Repeated Measures analysis including all data up to Week 4.||0.51|-1.00|
72365312|NCT02215252|144242336|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.27|STANDARD_ERROR_OF_MEAN|2.92|||TWO_SIDED|90.0|-5.12|4.57||||||Statistical analysis is only for Week 4. Mixed Models Repeated Measures analysis including all data up to Week 4.||4.57|-5.12|
72365313|NCT02215252|144242336|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.61|STANDARD_ERROR_OF_MEAN|2.99|||TWO_SIDED|90.0|-10.57|-0.66||||||Statistical analysis is only for Week 4. Mixed Models Repeated Measures analysis including all data up to Week 4.||-0.66|-10.57|
72365314|NCT02215252|144242337|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.7|||||TWO_SIDED|90.0|0.34|1.45||||||Statistical analysis is only for Week 4. Proportional Odds Logistic Regression including all data up to week 4.||1.45|0.34|
72365315|NCT02215252|144242337|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.5|||||TWO_SIDED|90.0|0.24|1.07||||||Statistical analysis is only for Week 4. Proportional Odds Logistic Regression including all data up to week 4.||1.07|0.24|
72365316|NCT02215252|144242338|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.59|STANDARD_ERROR_OF_MEAN|0.34|||TWO_SIDED|90.0|-1.16|-0.02||||||Statistical analysis is only for Week 4. Mixed Models Repeated Measures analysis including all data up to Week 4.||-0.02|-1.16|
72365317|NCT02215252|144242338|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0|STANDARD_ERROR_OF_MEAN|0.34|||TWO_SIDED|90.0|-1.57|-0.43||||||Statistical analysis is only for Week 4. Mixed Models Repeated Measures analysis including all data up to Week 4.||-0.43|-1.57|
72365318|NCT02215252|144242339|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|192.0|STANDARD_ERROR_OF_MEAN|816.0|||TWO_SIDED|90.0|-1161.0|1544.0||||||Statistical analysis is only for Week 4. Mixed Models Repeated Measures analysis including all data up to Week 4.||1544|-1161|
72365319|NCT02215252|144242339|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|611.0|STANDARD_ERROR_OF_MEAN|812.0|||TWO_SIDED|90.0|-735.0|1956.0||||||Statistical analysis is only for Week 4. Mixed Models Repeated Measures analysis including all data up to Week 4.||1956|-735|
72365320|NCT02215252|144242343|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.99|STANDARD_ERROR_OF_MEAN|3.03|||TWO_SIDED|90.0|2.98|13.01||||||Statistical analysis is only for Week 4. Mixed Model Repeated Measures analysis including all data up to Week 4.||13.01|2.98|
72365321|NCT02215252|144242343|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.75|STANDARD_ERROR_OF_MEAN|3.14|||TWO_SIDED|90.0|-4.46|5.95||||||Statistical analysis is only for Week 4. Mixed Model Repeated Measures analysis including all data up to Week 4.||5.95|-4.46|
72365322|NCT02215252|144242344|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.55|STANDARD_ERROR_OF_MEAN|5.19|||TWO_SIDED|90.0|2.94|20.17||||||Statistical analysis is only for Week 4. Mixed Model Repeated Measures analysis including all data up to Week 4.||20.17|2.94|
72365323|NCT02215252|144242344|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.42|STANDARD_ERROR_OF_MEAN|5.4|||TWO_SIDED|90.0|-11.38|6.54||||||Statistical analysis is only for Week 4. Mixed Model Repeated Measures analysis including all data up to Week 4.||6.54|-11.38|
72365324|NCT02633306|144242346|OTHER|||||||||||||||||In an exploratory trial with such a small number of participants no statistical analysis beyond descriptive statistics of the findings is appropriate. The descriptive statistics are reported.|In an exploratory trial with such a small number of participants no statistical analysis beyond descriptive statistics of the findings is appropriate. The descriptive statistics are reported.|||
72365325|NCT02633306|144242347|OTHER|||||||||||||||||In an exploratory trial with such a small number of participants no statistical analysis beyond descriptive statistics of the findings is appropriate. The descriptive statistics are reported.|In an exploratory trial with such a small number of participants no statistical analysis beyond descriptive statistics of the findings is appropriate. The descriptive statistics are reported.|||
72365326|NCT02633306|144242348|OTHER|||||||||||||||||In an exploratory trial with such a small number of participants no statistical analysis beyond descriptive statistics of the findings is appropriate. The descriptive statistics are reported.|In an exploratory trial with such a small number of participants no statistical analysis beyond descriptive statistics of the findings is appropriate. The descriptive statistics are reported.|||
72365327|NCT02633306|144242349|OTHER|||||||||||||||||In an exploratory trial with such a small number of participants no statistical analysis beyond descriptive statistics of the findings is appropriate. The descriptive statistics are reported.|In an exploratory trial with such a small number of participants no statistical analysis beyond descriptive statistics of the findings is appropriate. The descriptive statistics are reported.|||
72365328|NCT02633306|144242350|OTHER|||||||||||||||||In an exploratory trial with such a small number of participants no statistical analysis beyond descriptive statistics of the findings is appropriate. The descriptive statistics are reported.|In an exploratory trial with such a small number of participants no statistical analysis beyond descriptive statistics of the findings is appropriate. The descriptive statistics are reported.|||
72365329|NCT02633306|144242351|OTHER|||||||||||||||||In an exploratory trial with such a small number of participants no statistical analysis beyond descriptive statistics of the findings is appropriate. The descriptive statistics are reported.|In an exploratory trial with such a small number of participants no statistical analysis beyond descriptive statistics of the findings is appropriate. The descriptive statistics are reported.|||
72365330|NCT02633306|144242352|OTHER|||||||||||||||||In an exploratory trial with such a small number of participants no statistical analysis beyond descriptive statistics of the findings is appropriate. The descriptive statistics are reported.|In an exploratory trial with such a small number of participants no statistical analysis beyond descriptive statistics of the findings is appropriate. The descriptive statistics are reported.|||
72365331|NCT00956007|144242353|SUPERIORITY||Hazard Ratio (HR)|0.81||||0.0747|TWO_SIDED|95.0|0.6|1.08||One-sided significance level = 0.0183|Log Rank|Stratified by EGFR and site/p16 status|Stratified by EGFR and site/p16 status. Reference level = IMRT.|This trial was designed to detect a hazard ratio (HR) of 0.74 with 80% statistical power and overall one-sided alpha of 0.025 (372 deaths) using a stratified log-rank test, assuming a control arm 3-year survival rate of 60.1%. The amended protocol based on ≥ 5 years potential follow-up projected 169 events, providing 55%, 66%, and 79% power to detect HRs of 0.71, 0.68, and 0.64, respectively, using the original one-sided alpha of 0.0183 the final analysis.||1.08|0.60|0.0747
72365332|NCT00956007|144242354|SUPERIORITY|||||||0.0075|||||||Fisher Exact|||Dysphagia||||0.0075
72365333|NCT00956007|144242354|SUPERIORITY|||||||0.2955|||||||Fisher Exact|||Dry mouth||||0.2955
72365334|NCT00956007|144242354|SUPERIORITY|||||||0.0001|||||||Fisher Exact|||Dermatitis radiation||||0.0001
72365335|NCT00956007|144242354|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||Rach acneiform||||<0.0001
72365336|NCT00956007|144242355|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||||||<0.0001
72365337|NCT00956007|144242356|SUPERIORITY|||||||0.1641|||||||Fisher Exact|||Dysphagia||||0.1641
72365338|NCT00956007|144242356|SUPERIORITY|||||||0.2623|||||||Fisher Exact|||Dry mouth||||0.2623
72365339|NCT00956007|144242356|SUPERIORITY|||||||0.5378|||||||Fisher Exact|||Dermatitis radiation||||0.5378
72365340|NCT00956007|144242356|SUPERIORITY|||||||0.057|||||||Fisher Exact|||Rash acneiform||||0.0570
72365341|NCT00956007|144242357|SUPERIORITY|||||||0.1575|||||||Fisher Exact|||||||0.1575
72365342|NCT00956007|144242358|SUPERIORITY||Hazard Ratio (HR)|0.75||||0.0168|TWO_SIDED|95.0|0.57|0.98||One-sided|Log Rank|Stratified by EGFR and site/p16 status|Stratified by EGFR and site/p16 status. Reference level = IMRT.|||0.98|0.57|0.0168
72431728|NCT00495469|144375418|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.05||||0.767|TWO_SIDED|95.0|-0.4|0.3||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change = Baseline + Treatment||||0.30|-0.40|0.767
72365343|NCT01746901|144242368|SUPERIORITY_OR_OTHER||Least Squares (LS) Mean Difference|30.5|||<|0.0001|TWO_SIDED|95.0|24.4|36.6|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||36.6|24.4|<0.0001
72365344|NCT01746901|144242368|SUPERIORITY_OR_OTHER||LS Mean Difference|7.7||||0.0132|TWO_SIDED|95.0|1.6|13.7|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||13.7|1.6|0.0132
72365345|NCT01746901|144242368|SUPERIORITY_OR_OTHER||LS Mean Difference|15.3|||<|0.0001|TWO_SIDED|95.0|9.3|21.4|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||21.4|9.3|<0.0001
72365346|NCT01746901|144242368|SUPERIORITY_OR_OTHER||LS Mean Difference|22.9|||<|0.0001|TWO_SIDED|95.0|16.8|28.9|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||28.9|16.8|<0.0001
72365347|NCT01746901|144242368|SUPERIORITY_OR_OTHER||LS Mean Difference|15.3|||<|0.0001|TWO_SIDED|95.0|9.3|21.4|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||21.4|9.3|<0.0001
72365348|NCT01746901|144242368|SUPERIORITY_OR_OTHER||LS Mean Difference|18.5||||18.5|TWO_SIDED|95.0|12.5|24.6|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||24.6|12.5|18.5
72365349|NCT01746901|144242369|SUPERIORITY_OR_OTHER||LS Mean Difference|49.3|||<|0.0001|TWO_SIDED|95.0|39.2|59.5|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||59.5|39.2|<0.0001
72365350|NCT01746901|144242369|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0||||0.9994|TWO_SIDED|95.0|-10.1|10.1|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||10.1|-10.1|0.9994
72365351|NCT01746901|144242369|SUPERIORITY_OR_OTHER||LS Mean Difference|22.2|||<|0.0001|TWO_SIDED|95.0|12.1|32.4|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||32.4|12.1|<0.0001
72365352|NCT01746901|144242369|SUPERIORITY_OR_OTHER||LS Mean Difference|27.1|||<|0.0001|TWO_SIDED|95.0|17.0|37.3|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||37.3|17.0|<0.0001
72365353|NCT01746901|144242369|SUPERIORITY_OR_OTHER||LS Mean Difference|23.0|||<|0.0001|TWO_SIDED|95.0|12.8|33.1|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||33.1|12.8|<0.0001
72365354|NCT01746901|144242369|SUPERIORITY_OR_OTHER||LS Mean Difference|18.2||||0.0005|TWO_SIDED|95.0|8.1|28.4|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||28.4|8.1|0.0005
72365355|NCT01746901|144242370|SUPERIORITY_OR_OTHER||LS Mean Difference|63.2|||<|0.0001|TWO_SIDED|95.0|51.5|74.9|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||74.9|51.5|<0.0001
72365356|NCT01746901|144242370|SUPERIORITY_OR_OTHER||LS Mean Difference|12.3||||0.0402|TWO_SIDED|95.0|0.6|24.1|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||24.1|0.6|0.0402
72365357|NCT01746901|144242370|SUPERIORITY_OR_OTHER||LS Mean Difference|32.9|||<|0.0001|TWO_SIDED|95.0|21.1|44.7|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||44.7|21.1|<0.0001
72365358|NCT01746901|144242370|SUPERIORITY_OR_OTHER||LS Mean Difference|42.6|||<|0.0001|TWO_SIDED|95.0|30.9|54.4|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||54.4|30.9|<0.0001
72365359|NCT01746901|144242370|SUPERIORITY_OR_OTHER||LS Mean Difference|32.1|||<|0.0001|TWO_SIDED|95.0|20.3|43.9|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||43.9|20.3|<0.0001
72365360|NCT01746901|144242370|SUPERIORITY_OR_OTHER||LS Mean Difference|36.3|||<|0.0001|TWO_SIDED|95.0|24.6|48.1|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||48.1|24.6|<0.0001
72365361|NCT01746901|144242371|SUPERIORITY_OR_OTHER||LS Mean Difference|108.0|||<|0.0001|TWO_SIDED|95.0|91.6|124.5|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||124.5|91.6|<0.0001
72365362|NCT01746901|144242371|SUPERIORITY_OR_OTHER||LS Mean Difference|6.8||||0.4125|TWO_SIDED|95.0|-9.6|23.3|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||23.3|-9.6|0.4125
72365363|NCT01746901|144242371|SUPERIORITY_OR_OTHER||LS Mean Difference|46.1|||<|0.0001|TWO_SIDED|95.0|29.6|62.5|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||62.5|29.6|<0.0001
72365364|NCT01746901|144242371|SUPERIORITY_OR_OTHER||LS Mean Difference|68.8|||<|0.0001|TWO_SIDED|95.0|52.4|85.2|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||85.2|52.4|<0.0001
72365365|NCT01746901|144242371|SUPERIORITY_OR_OTHER||LS Mean Difference|56.7|||<|0.0001|TWO_SIDED|95.0|40.3|73.2|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||73.2|40.3|<0.0001
72365366|NCT01746901|144242371|SUPERIORITY_OR_OTHER||LS Mean Difference|52.6|||<|0.0001|TWO_SIDED|95.0|36.2|69.0|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||69.0|36.2|<0.0001
72365367|NCT01746901|144242372|SUPERIORITY_OR_OTHER||LS Mean Difference|32.8|||<|0.0001|TWO_SIDED|95.0|21.8|43.7|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||43.7|21.8|<0.0001
72365368|NCT01746901|144242372|SUPERIORITY_OR_OTHER||LS Mean Difference|2.6||||0.6434|TWO_SIDED|95.0|-8.4|13.5|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||13.5|-8.4|0.6434
72365369|NCT01746901|144242372|SUPERIORITY_OR_OTHER||LS Mean Difference|9.0||||0.1072|TWO_SIDED|95.0|-2.0|20.0|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||20.0|-2.0|0.1072
72365370|NCT01746901|144242372|SUPERIORITY_OR_OTHER||LS Mean Difference|26.3|||<|0.0001|TWO_SIDED|95.0|15.4|37.3|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||37.3|15.4|<0.0001
72365371|NCT01746901|144242372|SUPERIORITY_OR_OTHER||LS Mean Difference|25.7|||<|0.0001|TWO_SIDED|95.0|14.7|36.6|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||36.6|14.7|<0.0001
72365372|NCT01746901|144242372|SUPERIORITY_OR_OTHER||LS Mean Difference|11.9||||0.0335|TWO_SIDED|95.0|0.9|22.9|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||22.9|0.9|0.0335
72365373|NCT01746901|144242373|SUPERIORITY_OR_OTHER||LS Mean Difference|35.0|||<|0.0001|TWO_SIDED|95.0|24.0|46.0|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||46.0|24.0|<0.0001
72365374|NCT01746901|144242373|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1||||0.9811|TWO_SIDED|95.0|-11.1|10.8|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||10.8|-11.1|0.9811
72365375|NCT01746901|144242373|SUPERIORITY_OR_OTHER||LS Mean Difference|9.0||||0.1083|TWO_SIDED|95.0|-2.0|19.9|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||19.9|-2.0|0.1083
72365376|NCT01746901|144242373|SUPERIORITY_OR_OTHER||LS Mean Difference|25.9|||<|0.0001|TWO_SIDED|95.0|14.9|36.9|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||36.9|14.9|<0.0001
72365377|NCT01746901|144242373|SUPERIORITY_OR_OTHER||LS Mean Difference|23.2|||<|0.0001|TWO_SIDED|95.0|12.3|34.2|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||34.2|12.3|<0.0001
72365378|NCT01746901|144242373|SUPERIORITY_OR_OTHER||LS Mean Difference|11.5||||0.0408|TWO_SIDED|95.0|0.5|22.4|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||22.4|0.5|0.0408
72365379|NCT01746901|144242374|SUPERIORITY_OR_OTHER||LS Mean Difference|36.9|||<|0.0001|TWO_SIDED|95.0|25.2|48.7|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||48.7|25.2|<0.0001
72365380|NCT01746901|144242374|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.2||||0.5968|TWO_SIDED|95.0|-14.9|8.6|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||8.6|-14.9|0.5968
72365381|NCT01746901|144242374|SUPERIORITY_OR_OTHER||LS Mean Difference|8.7||||0.1471|TWO_SIDED|95.0|-3.1|20.4|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||20.4|-3.1|0.1471
72365382|NCT01746901|144242374|SUPERIORITY_OR_OTHER||LS Mean Difference|9.5||||0.1136|TWO_SIDED|95.0|-2.3|21.3|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||21.3|-2.3|0.1136
72365383|NCT01746901|144242374|SUPERIORITY_OR_OTHER||LS Mean Difference|22.4||||0.0002|TWO_SIDED|95.0|10.6|34.2|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||34.2|10.6|0.0002
72365384|NCT01746901|144242374|SUPERIORITY_OR_OTHER||LS Mean Difference|9.5||||0.1136|TWO_SIDED|95.0|-2.3|21.3|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||21.3|-2.3|0.1136
72365385|NCT01746901|144242376|SUPERIORITY_OR_OTHER||LS Mean Difference|28.5|||<|0.0001|TWO_SIDED|95.0|19.6|37.4|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||37.4|19.6|<0.0001
72365386|NCT01746901|144242376|SUPERIORITY_OR_OTHER||LS Mean Difference|2.2||||0.6209|TWO_SIDED|95.0|-6.7|11.1|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||11.1|-6.7|0.6209
72365387|NCT01746901|144242376|SUPERIORITY_OR_OTHER||LS Mean Difference|7.5||||0.0997|TWO_SIDED|95.0|-1.4|16.3|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||16.3|-1.4|0.0997
72365388|NCT01746901|144242376|SUPERIORITY_OR_OTHER||LS Mean Difference|23.2|||<|0.0001|TWO_SIDED|95.0|14.4|32.1|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||32.1|14.4|<0.0001
72365389|NCT01746901|144242376|SUPERIORITY_OR_OTHER||LS Mean Difference|16.6||||0.0003|TWO_SIDED|95.0|7.7|25.5|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||25.5|7.7|0.0003
72365390|NCT01746901|144242376|SUPERIORITY_OR_OTHER||LS Mean Difference|13.3||||0.0036|TWO_SIDED|95.0|4.4|22.2|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||22.2|4.4|0.0036
72365391|NCT01746901|144242377|SUPERIORITY_OR_OTHER||LS Mean Difference|29.9|||<|0.0001|TWO_SIDED|95.0|21.1|38.8|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||38.8|21.1|<0.0001
72365392|NCT01746901|144242377|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.4||||0.5951|TWO_SIDED|95.0|-11.2|6.4|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||6.4|-11.2|0.5951
72365393|NCT01746901|144242377|SUPERIORITY_OR_OTHER||LS Mean Difference|7.8||||0.0841|TWO_SIDED|95.0|-1.1|16.6|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||16.6|-1.1|0.0841
72365394|NCT01746901|144242377|SUPERIORITY_OR_OTHER||LS Mean Difference|19.8|||<|0.0001|TWO_SIDED|95.0|11.0|28.6|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||28.6|11.0|<0.0001
72365395|NCT01746901|144242377|SUPERIORITY_OR_OTHER||LS Mean Difference|14.5||||0.0014|TWO_SIDED|95.0|5.7|23.4|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||23.4|5.7|0.0014
72365396|NCT01746901|144242377|SUPERIORITY_OR_OTHER||LS Mean Difference|10.8||||0.0172|TWO_SIDED|95.0|1.9|19.6|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||19.6|1.9|0.0172
72365397|NCT01746901|144242378|SUPERIORITY_OR_OTHER||LS Mean Difference|30.4|||<|0.0001|TWO_SIDED|95.0|21.0|39.9|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||39.9|21.0|<0.0001
72365398|NCT01746901|144242378|SUPERIORITY_OR_OTHER||LS Mean Difference|-5.9||||0.2166|TWO_SIDED|95.0|-15.4|3.5|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||3.5|-15.4|0.2166
72365399|NCT01746901|144242378|SUPERIORITY_OR_OTHER||LS Mean Difference|8.5||||0.0777|TWO_SIDED|95.0|-1.0|18.0|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||18.0|-1.0|0.0777
72365400|NCT01746901|144242378|SUPERIORITY_OR_OTHER||LS Mean Difference|16.0||||0.0011|TWO_SIDED|95.0|6.5|25.4|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||25.4|6.5|0.0011
72365401|NCT01746901|144242378|SUPERIORITY_OR_OTHER||LS Mean Difference|12.7||||0.0086|TWO_SIDED|95.0|3.3|22.2|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||22.2|3.3|0.0086
72365402|NCT01746901|144242378|SUPERIORITY_OR_OTHER||LS Mean Difference|8.5||||0.0775|TWO_SIDED|95.0|-0.9|18.0|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||18.0|-0.9|0.0775
72365403|NCT01746901|144242380|SUPERIORITY_OR_OTHER||LS Mean Difference|61.2|||<|0.0001|TWO_SIDED|95.0|48.8|73.6|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||73.6|48.8|<0.0001
72365404|NCT01746901|144242380|SUPERIORITY_OR_OTHER||LS Mean Difference|18.8||||0.0032|TWO_SIDED|95.0|6.4|31.2|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||31.2|6.4|0.0032
72365405|NCT01746901|144242380|SUPERIORITY_OR_OTHER||LS Mean Difference|32.9|||<|0.0001|TWO_SIDED|95.0|20.5|45.3|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||45.3|20.5|<0.0001
72365406|NCT01746901|144242380|SUPERIORITY_OR_OTHER||LS Mean Difference|47.2|||<|0.0001|TWO_SIDED|95.0|34.8|59.6|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||59.6|34.8|<0.0001
72365407|NCT01746901|144242380|SUPERIORITY_OR_OTHER||LS Mean Difference|73.6|||<|0.0001|TWO_SIDED|95.0|61.1|86.0|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||86.0|61.1|<0.0001
72365408|NCT01746901|144242380|SUPERIORITY_OR_OTHER||LS Mean Difference|38.4|||<|0.0001|TWO_SIDED|95.0|26.0|50.8|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||50.8|26.0|<0.0001
72365409|NCT01746901|144242381|SUPERIORITY_OR_OTHER||LS Mean Difference|43.9|||<|0.0001|TWO_SIDED|95.0|36.0|51.8|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||51.8|36.0|<0.0001
72365410|NCT01746901|144242381|SUPERIORITY_OR_OTHER||LS Mean Difference|3.3||||0.4154|TWO_SIDED|95.0|-4.6|11.2|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||11.2|-4.6|0.4154
72365411|NCT01746901|144242381|SUPERIORITY_OR_OTHER||LS Mean Difference|21.8|||<|0.0001|TWO_SIDED|95.0|13.9|29.7|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||29.7|13.9|<0.0001
72365412|NCT01746901|144242381|SUPERIORITY_OR_OTHER||LS Mean Difference|25.4|||<|0.0001|TWO_SIDED|95.0|17.5|33.3|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||33.3|17.5|<0.0001
72365413|NCT01746901|144242381|SUPERIORITY_OR_OTHER||LS Mean Difference|20.2|||<|0.0001|TWO_SIDED|95.0|12.3|28.1|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||28.1|12.3|<0.0001
72365414|NCT01746901|144242381|SUPERIORITY_OR_OTHER||LS Mean Difference|18.9|||<|0.0001|TWO_SIDED|95.0|11.0|26.8|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||26.8|11.0|<0.0001
72365415|NCT01746901|144242381|SUPERIORITY_OR_OTHER||LS Mean Difference|114.2|||<|0.0001|TWO_SIDED|95.0|97.1|131.3|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||131.3|97.1|<0.0001
72365416|NCT01746901|144242381|SUPERIORITY_OR_OTHER||LS Mean Difference|7.3||||0.3985|TWO_SIDED|95.0|-9.8|24.4|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||24.4|-9.8|0.3985
72365417|NCT01746901|144242381|SUPERIORITY_OR_OTHER||LS Mean Difference|55.6|||<|0.0001|TWO_SIDED|95.0|38.5|72.8|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||72.8|38.5|<0.0001
72365418|NCT01746901|144242381|SUPERIORITY_OR_OTHER||LS Mean Difference|65.9|||<|0.0001|TWO_SIDED|95.0|48.8|83.0|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||83.0|48.8|<0.0001
72365419|NCT01746901|144242381|SUPERIORITY_OR_OTHER||LS Mean Difference|55.6|||<|0.0001|TWO_SIDED|95.0|38.5|72.7|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||72.7|38.5|<0.0001
72365420|NCT01746901|144242381|SUPERIORITY_OR_OTHER||LS Mean Difference|54.1|||<|0.0001|TWO_SIDED|95.0|37.0|71.2|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||71.2|37.0|<0.0001
72365421|NCT01746901|144242381|SUPERIORITY_OR_OTHER||LS Mean Difference|302.8|||<|0.0001|TWO_SIDED|95.0|248.8|356.8|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||356.8|248.8|<0.0001
72365422|NCT01746901|144242381|SUPERIORITY_OR_OTHER||LS Mean Difference|47.8||||0.0824|TWO_SIDED|95.0|-6.2|101.7|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||101.7|-6.2|0.0824
72365423|NCT01746901|144242381|SUPERIORITY_OR_OTHER||LS Mean Difference|188.5|||<|0.0001|TWO_SIDED|95.0|134.6|242.5|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||242.5|134.6|<0.0001
72365424|NCT01746901|144242381|SUPERIORITY_OR_OTHER||LS Mean Difference|162.0|||<|0.0001|TWO_SIDED|95.0|108.0|216.0|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||216.0|108.0|<0.0001
72365425|NCT01746901|144242381|SUPERIORITY_OR_OTHER||LS Mean Difference|141.9|||<|0.0001|TWO_SIDED|95.0|87.9|195.8|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||195.8|87.9|<0.0001
72365426|NCT01746901|144242381|SUPERIORITY_OR_OTHER||LS Mean Difference|135.7|||<|0.0001|TWO_SIDED|95.0|81.7|189.6|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||189.6|81.7|<0.0001
72365427|NCT01746901|144242381|SUPERIORITY_OR_OTHER||LS Mean Difference|287.6|||<|0.0001|TWO_SIDED|95.0|219.1|356.1|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||356.1|219.1|<0.0001
72365428|NCT01746901|144242381|SUPERIORITY_OR_OTHER||LS Mean Difference|101.4||||0.004|TWO_SIDED|95.0|32.9|169.8|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||169.8|32.9|0.0040
72365429|NCT01746901|144242381|SUPERIORITY_OR_OTHER||LS Mean Difference|218.5|||<|0.0001|TWO_SIDED|95.0|150.0|287.0|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||287.0|150.0|<0.0001
72365430|NCT01746901|144242381|SUPERIORITY_OR_OTHER||LS Mean Difference|170.5|||<|0.0001|TWO_SIDED|95.0|102.0|239.0|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||239.0|102.0|<0.0001
72365431|NCT01746901|144242381|SUPERIORITY_OR_OTHER||LS Mean Difference|158.6|||<|0.0001|TWO_SIDED|95.0|90.1|227.1|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||227.1|90.1|<0.0001
72365432|NCT01746901|144242381|SUPERIORITY_OR_OTHER||LS Mean Difference|152.2|||<|0.0001|TWO_SIDED|95.0|83.7|220.7|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||220.7|83.7|<0.0001
72365433|NCT01746901|144242381|SUPERIORITY_OR_OTHER||LS Mean Difference|185.9||||0.0002|TWO_SIDED|95.0|90.1|281.8|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||281.8|90.1|0.0002
72365434|NCT01746901|144242381|SUPERIORITY_OR_OTHER||LS Mean Difference|205.0|||<|0.0001|TWO_SIDED|95.0|109.2|300.8|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||300.8|109.2|<0.0001
72365435|NCT01746901|144242381|SUPERIORITY_OR_OTHER||LS Mean Difference|221.0|||<|0.0001|TWO_SIDED|95.0|125.2|316.7|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||316.7|125.2|<0.0001
72365436|NCT01746901|144242381|SUPERIORITY_OR_OTHER||LS Mean Difference|170.0||||0.0006|TWO_SIDED|95.0|74.1|265.8|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||265.8|74.1|0.0006
72365437|NCT01746901|144242381|SUPERIORITY_OR_OTHER||LS Mean Difference|185.7||||0.0002|TWO_SIDED|95.0|89.9|281.5|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||281.5|89.9|0.0002
72431729|NCT00495469|144375418|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1||||0.604|TWO_SIDED|95.0|-0.46|0.27||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change = Baseline + Treatment||||0.27|-0.46|0.604
72365438|NCT01746901|144242381|SUPERIORITY_OR_OTHER||LS Mean Difference|144.9||||0.0033|TWO_SIDED|95.0|49.1|240.8|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||240.8|49.1|0.0033
72365439|NCT01746901|144242381|SUPERIORITY_OR_OTHER||LS Mean Difference|170.0||||0.0017|TWO_SIDED|95.0|65.2|274.9|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||274.9|65.2|0.0017
72365440|NCT01746901|144242381|SUPERIORITY_OR_OTHER||LS Mean Difference|211.4||||0.0001|TWO_SIDED|95.0|106.6|316.2|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||316.2|106.6|0.0001
72365441|NCT01746901|144242381|SUPERIORITY_OR_OTHER||LS Mean Difference|219.2|||<|0.0001|TWO_SIDED|95.0|114.5|324.0|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||324.0|114.5|<0.0001
72365442|NCT01746901|144242381|SUPERIORITY_OR_OTHER||LS Mean Difference|162.2||||0.0027|TWO_SIDED|95.0|57.3|267.0|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||267.0|57.3|0.0027
72365443|NCT01746901|144242381|SUPERIORITY_OR_OTHER||LS Mean Difference|185.9||||0.0006|TWO_SIDED|95.0|81.1|290.7|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||290.7|81.1|0.0006
72365444|NCT01746901|144242381|SUPERIORITY_OR_OTHER||LS Mean Difference|135.5||||0.0116|TWO_SIDED|95.0|30.7|240.4|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||240.4|30.7|0.0116
72365445|NCT01746901|144242382|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.9|||<|0.0001|TWO_SIDED|95.0|-4.3|-1.5|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-1.5|-4.3|<0.0001
72365446|NCT01746901|144242382|SUPERIORITY_OR_OTHER||LS Mean Difference|2.8||||0.0001|TWO_SIDED|95.0|1.4|4.2|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||4.2|1.4|0.0001
72365447|NCT01746901|144242382|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3||||0.7005|TWO_SIDED|95.0|-1.7|1.1|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||1.1|-1.7|0.7005
72365448|NCT01746901|144242382|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1||||0.844|TWO_SIDED|95.0|-1.3|1.5|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||1.5|-1.3|0.8440
72365449|NCT01746901|144242382|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2||||0.7295|TWO_SIDED|95.0|-1.6|1.1|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||1.1|-1.6|0.7295
72365450|NCT01746901|144242382|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1||||0.8757|TWO_SIDED|95.0|-1.3|1.5|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||1.5|-1.3|0.8757
72365451|NCT01746901|144242383|SUPERIORITY_OR_OTHER||LS Mean Difference|60.1|||<|0.0001|TWO_SIDED|95.0|47.4|72.9|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||72.9|47.4|<0.0001
72365452|NCT01746901|144242383|SUPERIORITY_OR_OTHER||LS Mean Difference|12.6||||0.0514|TWO_SIDED|95.0|-0.1|25.4|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||25.4|-0.1|0.0514
72365453|NCT01746901|144242383|SUPERIORITY_OR_OTHER||LS Mean Difference|29.7|||<|0.0001|TWO_SIDED|95.0|17.0|42.4|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||42.4|17.0|<0.0001
72365454|NCT01746901|144242383|SUPERIORITY_OR_OTHER||LS Mean Difference|43.0|||<|0.0001|TWO_SIDED|95.0|30.3|55.8|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||55.8|30.3|<0.0001
72365455|NCT01746901|144242383|SUPERIORITY_OR_OTHER||LS Mean Difference|33.7|||<|0.0001|TWO_SIDED|95.0|21.0|46.4|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||46.4|21.0|<0.0001
72365456|NCT01746901|144242383|SUPERIORITY_OR_OTHER||LS Mean Difference|36.4|||<|0.0001|TWO_SIDED|95.0|23.7|49.1|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||49.1|23.7|<0.0001
72365457|NCT01746901|144242384|SUPERIORITY_OR_OTHER||LS Mean Difference|39.5|||<|0.0001|TWO_SIDED|95.0|31.8|47.2|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||47.2|31.8|<0.0001
72365458|NCT01746901|144242384|SUPERIORITY_OR_OTHER||LS Mean Difference|4.3||||0.2739|TWO_SIDED|95.0|-3.4|12.0|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||12.0|-3.4|0.2739
72365459|NCT01746901|144242384|SUPERIORITY_OR_OTHER||LS Mean Difference|16.4|||<|0.0001|TWO_SIDED|95.0|8.7|24.1|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||24.1|8.7|<0.0001
72365460|NCT01746901|144242384|SUPERIORITY_OR_OTHER||LS Mean Difference|27.4|||<|0.0001|TWO_SIDED|95.0|19.7|35.0|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||35.0|19.7|<0.0001
72365461|NCT01746901|144242384|SUPERIORITY_OR_OTHER||LS Mean Difference|20.5|||<|0.0001|TWO_SIDED|95.0|12.8|28.2|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||28.2|12.8|<0.0001
72365462|NCT01746901|144242384|SUPERIORITY_OR_OTHER||LS Mean Difference|19.7|||<|0.0001|TWO_SIDED|95.0|12.0|27.4|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||27.4|12.0|<0.0001
72365463|NCT01746901|144242384|SUPERIORITY_OR_OTHER||LS Mean Difference|104.7|||<|0.0001|TWO_SIDED|95.0|87.7|121.8|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||121.8|87.7|<0.0001
72365464|NCT01746901|144242384|SUPERIORITY_OR_OTHER||LS Mean Difference|7.3||||0.4003|TWO_SIDED|95.0|-9.8|24.3|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||24.3|-9.8|0.4003
72365465|NCT01746901|144242384|SUPERIORITY_OR_OTHER||LS Mean Difference|43.6|||<|0.0001|TWO_SIDED|95.0|26.6|60.7|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||60.7|26.6|<0.0001
72365466|NCT01746901|144242384|SUPERIORITY_OR_OTHER||LS Mean Difference|68.4|||<|0.0001|TWO_SIDED|95.0|51.3|85.4|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||85.4|51.3|<0.0001
72365467|NCT01746901|144242384|SUPERIORITY_OR_OTHER||LS Mean Difference|54.3|||<|0.0001|TWO_SIDED|95.0|37.3|71.4|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||71.4|37.3|<0.0001
72365468|NCT01746901|144242384|SUPERIORITY_OR_OTHER||LS Mean Difference|53.0|||<|0.0001|TWO_SIDED|95.0|36.0|70.1|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||70.1|36.0|<0.0001
72365469|NCT01746901|144242384|SUPERIORITY_OR_OTHER||LS Mean Difference|292.5|||<|0.0001|TWO_SIDED|95.0|240.0|345.1|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||345.1|240.0|<0.0001
72365470|NCT01746901|144242384|SUPERIORITY_OR_OTHER||LS Mean Difference|32.2||||0.2277|TWO_SIDED|95.0|-20.3|84.7|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||84.7|-20.3|0.2277
72365471|NCT01746901|144242384|SUPERIORITY_OR_OTHER||LS Mean Difference|173.1|||<|0.0001|TWO_SIDED|95.0|120.5|225.6|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||225.6|120.5|<0.0001
72365472|NCT01746901|144242384|SUPERIORITY_OR_OTHER||LS Mean Difference|151.7|||<|0.0001|TWO_SIDED|95.0|99.1|204.2|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||204.2|99.1|<0.0001
72365473|NCT01746901|144242384|SUPERIORITY_OR_OTHER||LS Mean Difference|129.8|||<|0.0001|TWO_SIDED|95.0|77.2|182.3|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||182.3|77.2|<0.0001
72365474|NCT01746901|144242384|SUPERIORITY_OR_OTHER||LS Mean Difference|122.6|||<|0.0001|TWO_SIDED|95.0|70.0|175.1|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||175.1|70.0|<0.0001
72365475|NCT01746901|144242384|SUPERIORITY_OR_OTHER||LS Mean Difference|295.3|||<|0.0001|TWO_SIDED|95.0|228.3|362.2|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||362.2|228.3|<0.0001
72365476|NCT01746901|144242384|SUPERIORITY_OR_OTHER||LS Mean Difference|69.6||||0.0416|TWO_SIDED|95.0|2.7|136.5|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||136.5|2.7|0.0416
72365477|NCT01746901|144242384|SUPERIORITY_OR_OTHER||LS Mean Difference|204.4|||<|0.0001|TWO_SIDED|95.0|137.5|271.3|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||271.3|137.5|<0.0001
72365478|NCT01746901|144242384|SUPERIORITY_OR_OTHER||LS Mean Difference|160.5|||<|0.0001|TWO_SIDED|95.0|93.5|227.4|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||227.4|93.5|<0.0001
72365479|NCT01746901|144242384|SUPERIORITY_OR_OTHER||LS Mean Difference|133.0||||0.0001|TWO_SIDED|95.0|66.1|199.9|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||199.9|66.1|0.0001
72365480|NCT01746901|144242384|SUPERIORITY_OR_OTHER||LS Mean Difference|140.1|||<|0.0001|TWO_SIDED|95.0|73.1|207.0|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||207.0|73.1|<0.0001
72365481|NCT01746901|144242384|SUPERIORITY_OR_OTHER||LS Mean Difference|219.5|||<|0.0001|TWO_SIDED|95.0|127.6|311.3|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||311.3|127.6|<0.0001
72365482|NCT01746901|144242384|SUPERIORITY_OR_OTHER||LS Mean Difference|145.0||||0.0022|TWO_SIDED|95.0|53.2|236.8|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||236.8|53.2|0.0022
72365483|NCT01746901|144242384|SUPERIORITY_OR_OTHER||LS Mean Difference|200.2|||<|0.0001|TWO_SIDED|95.0|108.4|292.0|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||292.0|108.4|<0.0001
72365484|NCT01746901|144242384|SUPERIORITY_OR_OTHER||LS Mean Difference|164.3||||0.0005|TWO_SIDED|95.0|72.4|256.1|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||256.1|72.4|0.0005
72431730|NCT00495469|144375418|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.13||||0.483|TWO_SIDED|95.0|-0.23|0.48||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change = Baseline + Treatment||||0.48|-0.23|0.483
72365485|NCT01746901|144242384|SUPERIORITY_OR_OTHER||LS Mean Difference|146.6||||0.0019|TWO_SIDED|95.0|54.8|238.4|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||238.4|54.8|0.0019
72365486|NCT01746901|144242384|SUPERIORITY_OR_OTHER||LS Mean Difference|132.7||||0.0049|TWO_SIDED|95.0|40.8|224.5|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||224.5|40.8|0.0049
72365487|NCT01746901|144242384|SUPERIORITY_OR_OTHER||LS Mean Difference|209.3|||<|0.0001|TWO_SIDED|95.0|108.3|310.3|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||310.3|108.3|<0.0001
72365488|NCT01746901|144242384|SUPERIORITY_OR_OTHER||LS Mean Difference|145.7||||0.005|TWO_SIDED|95.0|44.7|246.6|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||246.6|44.7|0.0050
72365489|NCT01746901|144242384|SUPERIORITY_OR_OTHER||LS Mean Difference|200.7||||0.0001|TWO_SIDED|95.0|99.7|301.6|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||301.6|99.7|0.0001
72365490|NCT01746901|144242384|SUPERIORITY_OR_OTHER||LS Mean Difference|154.3||||0.003|TWO_SIDED|95.0|53.3|255.3|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||255.3|53.3|0.0030
72365491|NCT01746901|144242384|SUPERIORITY_OR_OTHER||LS Mean Difference|146.8||||0.0046|TWO_SIDED|95.0|45.9|247.8|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||247.8|45.9|0.0046
72365492|NCT01746901|144242384|SUPERIORITY_OR_OTHER||LS Mean Difference|123.3||||0.0171|TWO_SIDED|95.0|22.3|224.3|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||224.3|22.3|0.0171
72365493|NCT01746901|144242385|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.3||||0.0016|TWO_SIDED|95.0|-3.7|-0.9|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-0.9|-3.7|0.0016
72365494|NCT01746901|144242385|SUPERIORITY_OR_OTHER||LS Mean Difference|1.9||||0.0105|TWO_SIDED|95.0|0.4|3.3|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||3.3|0.4|0.0105
72365495|NCT01746901|144242385|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3||||0.7259|TWO_SIDED|95.0|-1.7|1.2|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||1.2|-1.7|0.7259
72365496|NCT01746901|144242385|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2||||0.7813|TWO_SIDED|95.0|-1.6|1.2|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||1.2|-1.6|0.7813
72365497|NCT01746901|144242385|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.5||||0.5235|TWO_SIDED|95.0|-1.9|1.0|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||1.0|-1.9|0.5235
72365498|NCT01746901|144242385|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1||||0.8512|TWO_SIDED|95.0|-1.6|1.3|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||1.3|-1.6|0.8512
72365499|NCT01746901|144242386|SUPERIORITY_OR_OTHER||LS Mean Difference|11.1||||0.0883|TWO_SIDED|95.0|-1.7|23.9|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||23.9|-1.7|0.0883
72365500|NCT01746901|144242386|SUPERIORITY_OR_OTHER||LS Mean Difference|14.8||||0.0241|TWO_SIDED|95.0|2.0|27.6|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||27.6|2.0|0.0241
72365501|NCT01746901|144242386|SUPERIORITY_OR_OTHER||LS Mean Difference|14.8||||0.0235|TWO_SIDED|95.0|2.0|27.6|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||27.6|2.0|0.0235
72365502|NCT01746901|144242386|SUPERIORITY_OR_OTHER||LS Mean Difference|11.1||||0.0901|TWO_SIDED|95.0|-1.7|23.9|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||23.9|-1.7|0.0901
72365503|NCT01746901|144242386|SUPERIORITY_OR_OTHER||LS Mean Difference|9.8||||0.1313|TWO_SIDED|95.0|-3.0|22.6|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||22.6|-3.0|0.1313
72365504|NCT01746901|144242386|SUPERIORITY_OR_OTHER||LS Mean Difference|10.8||||0.0982|TWO_SIDED|95.0|-2.0|23.6|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||23.6|-2.0|0.0982
72365505|NCT01746901|144242387|SUPERIORITY_OR_OTHER||LS Mean Difference|3.3||||0.0351|TWO_SIDED|95.0|0.2|6.3|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||6.3|0.2|0.0351
72365506|NCT01746901|144242387|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2||||0.8751|TWO_SIDED|95.0|-3.3|2.8|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||2.8|-3.3|0.8751
72365507|NCT01746901|144242387|SUPERIORITY_OR_OTHER||LS Mean Difference|2.7||||0.0795|TWO_SIDED|95.0|-0.3|5.8|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||5.8|-0.3|0.0795
72365508|NCT01746901|144242387|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3||||0.8382|TWO_SIDED|95.0|-2.7|3.4|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||3.4|-2.7|0.8382
72365509|NCT01746901|144242387|SUPERIORITY_OR_OTHER||LS Mean Difference|3.4||||0.0289|TWO_SIDED|95.0|0.4|6.4|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||6.4|0.4|0.0289
72365510|NCT01746901|144242387|SUPERIORITY_OR_OTHER||LS Mean Difference|0.4||||0.7878|TWO_SIDED|95.0|-2.6|3.5|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||3.5|-2.6|0.7878
72365511|NCT01746901|144242387|SUPERIORITY_OR_OTHER||LS Mean Difference|14.8||||0.0019|TWO_SIDED|95.0|5.6|24.0|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||24.0|5.6|0.0019
72365512|NCT01746901|144242387|SUPERIORITY_OR_OTHER||LS Mean Difference|1.1||||0.821|TWO_SIDED|95.0|-8.1|10.3|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||10.3|-8.1|0.821
72365513|NCT01746901|144242387|SUPERIORITY_OR_OTHER||LS Mean Difference|12.3||||0.0094|TWO_SIDED|95.0|3.1|21.5|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||21.5|3.1|0.0094
72365514|NCT01746901|144242387|SUPERIORITY_OR_OTHER||LS Mean Difference|3.6||||0.4454|TWO_SIDED|95.0|-5.6|12.8|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||12.8|-5.6|0.4454
72365515|NCT01746901|144242387|SUPERIORITY_OR_OTHER||LS Mean Difference|7.9||||0.0934|TWO_SIDED|95.0|-1.3|17.1|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||17.1|-1.3|0.0934
72365516|NCT01746901|144242387|SUPERIORITY_OR_OTHER||LS Mean Difference|7.0||||0.1358|TWO_SIDED|95.0|-2.2|16.2|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||16.2|-2.2|0.1358
72365517|NCT01746901|144242387|SUPERIORITY_OR_OTHER||LS Mean Difference|59.8||||0.0004|TWO_SIDED|95.0|27.0|92.7|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||92.7|27.0|0.0004
72365518|NCT01746901|144242387|SUPERIORITY_OR_OTHER||LS Mean Difference|19.7||||0.2365|TWO_SIDED|95.0|-13.1|52.6|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||52.6|-13.1|0.2365
72365519|NCT01746901|144242387|SUPERIORITY_OR_OTHER||LS Mean Difference|43.9||||0.0091|TWO_SIDED|95.0|11.1|76.7|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||76.7|11.1|0.0091
72365520|NCT01746901|144242387|SUPERIORITY_OR_OTHER||LS Mean Difference|35.7||||0.0335|TWO_SIDED|95.0|2.8|68.5|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||68.5|2.8|0.0335
72365521|NCT01746901|144242387|SUPERIORITY_OR_OTHER||LS Mean Difference|30.8||||0.0661|TWO_SIDED|95.0|-2.1|63.6|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||63.6|-2.1|0.0661
72365522|NCT01746901|144242387|SUPERIORITY_OR_OTHER||LS Mean Difference|26.9||||0.1074|TWO_SIDED|95.0|-5.9|59.8|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||59.8|-5.9|0.1074
72365523|NCT01746901|144242387|SUPERIORITY_OR_OTHER||LS Mean Difference|55.3||||0.0064|TWO_SIDED|95.0|15.8|94.9|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||94.9|15.8|0.0064
72365524|NCT01746901|144242387|SUPERIORITY_OR_OTHER||LS Mean Difference|38.8||||0.0543|TWO_SIDED|95.0|-0.7|78.3|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||78.3|-0.7|0.0543
72365525|NCT01746901|144242387|SUPERIORITY_OR_OTHER||LS Mean Difference|50.2||||0.0131|TWO_SIDED|95.0|10.7|89.7|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||89.7|10.7|0.0131
72365526|NCT01746901|144242387|SUPERIORITY_OR_OTHER||LS Mean Difference|43.9||||0.0297|TWO_SIDED|95.0|4.4|83.5|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||83.5|4.4|0.0297
72365527|NCT01746901|144242387|SUPERIORITY_OR_OTHER||LS Mean Difference|41.3||||0.0407|TWO_SIDED|95.0|1.8|80.8|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||80.8|1.8|0.0407
72431731|NCT00495469|144375418|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.01||||0.956|TWO_SIDED|95.0|-0.35|0.37||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change = Baseline + Treatment||||0.37|-0.35|0.956
72365528|NCT01746901|144242387|SUPERIORITY_OR_OTHER||LS Mean Difference|27.5||||0.171|TWO_SIDED|95.0|-12.0|67.1|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||67.1|-12.0|0.1710
72365529|NCT01746901|144242387|SUPERIORITY_OR_OTHER||LS Mean Difference|-35.0||||0.3362|TWO_SIDED|95.0|-106.7|36.7|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||36.7|-106.7|0.3362
72365530|NCT01746901|144242387|SUPERIORITY_OR_OTHER||LS Mean Difference|126.9||||0.0006|TWO_SIDED|95.0|55.2|198.5|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||198.5|55.2|0.0006
72365531|NCT01746901|144242387|SUPERIORITY_OR_OTHER||LS Mean Difference|53.2||||0.1449|TWO_SIDED|95.0|-18.5|124.8|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||124.8|-18.5|0.1449
72365532|NCT01746901|144242387|SUPERIORITY_OR_OTHER||LS Mean Difference|38.7||||0.2882|TWO_SIDED|95.0|-33.0|110.4|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||110.4|-33.0|0.2882
72365533|NCT01746901|144242387|SUPERIORITY_OR_OTHER||LS Mean Difference|55.0||||0.1314|TWO_SIDED|95.0|-16.6|126.7|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||126.7|-16.6|0.1314
72365534|NCT01746901|144242387|SUPERIORITY_OR_OTHER||LS Mean Difference|20.1||||0.5808|TWO_SIDED|95.0|-51.6|91.8|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||91.8|-51.6|0.5808
72365535|NCT01746901|144242387|SUPERIORITY_OR_OTHER||LS Mean Difference|-66.2||||0.1415|TWO_SIDED|95.0|-154.6|22.3|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||22.3|-154.6|0.1415
72365536|NCT01746901|144242387|SUPERIORITY_OR_OTHER||LS Mean Difference|149.1||||0.0011|TWO_SIDED|95.0|60.7|237.5|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||237.5|60.7|0.0011
72365537|NCT01746901|144242387|SUPERIORITY_OR_OTHER||LS Mean Difference|52.5||||0.2423|TWO_SIDED|95.0|-35.9|140.9|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||140.9|-35.9|0.2423
72365538|NCT01746901|144242387|SUPERIORITY_OR_OTHER||LS Mean Difference|30.4||||0.498|TWO_SIDED|95.0|-58.0|118.8|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||118.8|-58.0|0.4980
72365539|NCT01746901|144242387|SUPERIORITY_OR_OTHER||LS Mean Difference|54.5||||0.2253|TWO_SIDED|95.0|-33.9|142.9|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||142.9|-33.9|0.2253
72365540|NCT01746901|144242387|SUPERIORITY_OR_OTHER||LS Mean Difference|11.7||||0.7945|TWO_SIDED|95.0|-76.8|100.1|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||100.1|-76.8|0.7945
72365541|NCT01746901|144242388|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.8||||0.0129|TWO_SIDED|95.0|-5.1|-0.6|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-0.6|-5.1|0.0129
72365542|NCT01746901|144242388|SUPERIORITY_OR_OTHER||LS Mean Difference|4.2||||0.0003|TWO_SIDED|95.0|2.0|6.5|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||6.5|2.0|0.0003
72365543|NCT01746901|144242388|SUPERIORITY_OR_OTHER||LS Mean Difference|0.7||||0.5483|TWO_SIDED|95.0|-1.6|2.9|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||2.9|-1.6|0.5483
72365544|NCT01746901|144242388|SUPERIORITY_OR_OTHER||LS Mean Difference|0.7||||0.5284|TWO_SIDED|95.0|-1.5|2.9|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||2.9|-1.5|0.5284
72365545|NCT01746901|144242388|SUPERIORITY_OR_OTHER||LS Mean Difference|1.7||||0.1331|TWO_SIDED|95.0|-0.5|3.9|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||3.9|-0.5|0.1331
72365546|NCT01746901|144242388|SUPERIORITY_OR_OTHER||LS Mean Difference|0.2||||0.8732|TWO_SIDED|95.0|-2.1|2.4|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||2.4|-2.1|0.8732
72365547|NCT01746901|144242389|SUPERIORITY_OR_OTHER||LS Mean Difference|3.6||||0.4555|TWO_SIDED|95.0|-5.9|13.2|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||13.2|-5.9|0.4555
72365548|NCT01746901|144242389|SUPERIORITY_OR_OTHER||LS Mean Difference|6.9||||0.1495|TWO_SIDED|95.0|-2.5|16.4|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||16.4|-2.5|0.1495
72365549|NCT01746901|144242389|SUPERIORITY_OR_OTHER||LS Mean Difference|11.4||||0.02|TWO_SIDED|95.0|1.8|20.9|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||20.9|1.8|0.0200
72365550|NCT01746901|144242389|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.8||||0.8668|TWO_SIDED|95.0|-10.3|8.7|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||8.7|-10.3|0.8668
72365551|NCT01746901|144242389|SUPERIORITY_OR_OTHER||LS Mean Difference|4.1||||0.3904|TWO_SIDED|95.0|-5.3|13.6|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||13.6|-5.3|0.3904
72365552|NCT01746901|144242389|SUPERIORITY_OR_OTHER||LS Mean Difference|2.2||||0.6524|TWO_SIDED|95.0|-7.3|11.6|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||11.6|-7.3|0.6524
72365553|NCT01746901|144242390|SUPERIORITY_OR_OTHER||LS Mean Difference|0.8||||0.1771|TWO_SIDED|95.0|-0.4|2.1|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||2.1|-0.4|0.1771
72365554|NCT01746901|144242390|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.5||||0.3944|TWO_SIDED|95.0|-1.7|0.7|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||0.7|-1.7|0.3944
72365555|NCT01746901|144242390|SUPERIORITY_OR_OTHER||LS Mean Difference|0.8||||0.1778|TWO_SIDED|95.0|-0.4|2.1|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||2.1|-0.4|0.1778
72365556|NCT01746901|144242390|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.5||||0.396|TWO_SIDED|95.0|-1.7|0.7|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||0.7|-1.7|0.3960
72365557|NCT01746901|144242390|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3||||0.6125|TWO_SIDED|95.0|-0.9|1.5|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||1.5|-0.9|0.6125
72365558|NCT01746901|144242390|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1||||0.9059|TWO_SIDED|95.0|-1.1|1.3|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||1.3|-1.1|0.9059
72365559|NCT01746901|144242390|SUPERIORITY_OR_OTHER||LS Mean Difference|1.7||||0.4585|TWO_SIDED|95.0|-2.9|6.3|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||6.3|-2.9|0.4585
72365560|NCT01746901|144242390|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3||||0.8986|TWO_SIDED|95.0|-4.2|4.8|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||4.8|-4.2|0.8986
72365561|NCT01746901|144242390|SUPERIORITY_OR_OTHER||LS Mean Difference|2.1||||0.3641|TWO_SIDED|95.0|-2.5|6.7|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||6.7|-2.5|0.3641
72365562|NCT01746901|144242390|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1||||0.9674|TWO_SIDED|95.0|-4.6|4.4|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||4.4|-4.6|0.9674
72365563|NCT01746901|144242390|SUPERIORITY_OR_OTHER||LS Mean Difference|1.3||||0.5744|TWO_SIDED|95.0|-3.2|5.8|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||5.8|-3.2|0.5744
72365564|NCT01746901|144242390|SUPERIORITY_OR_OTHER||LS Mean Difference|2.2||||0.3457|TWO_SIDED|95.0|-2.4|6.7|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||6.7|-2.4|0.3457
72365565|NCT01746901|144242390|SUPERIORITY_OR_OTHER||LS Mean Difference|3.7||||0.6664|TWO_SIDED|95.0|-13.3|20.8|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||20.8|-13.3|0.6664
72365566|NCT01746901|144242390|SUPERIORITY_OR_OTHER||LS Mean Difference|11.1||||0.1949|TWO_SIDED|95.0|-5.8|28.0|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||28.0|-5.8|0.1949
72365567|NCT01746901|144242390|SUPERIORITY_OR_OTHER||LS Mean Difference|11.1||||0.2009|TWO_SIDED|95.0|-6.0|28.1|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||28.1|-6.0|0.2009
72365568|NCT01746901|144242390|SUPERIORITY_OR_OTHER||LS Mean Difference|3.8||||0.6595|TWO_SIDED|95.0|-13.1|20.7|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||20.7|-13.1|0.6595
72365569|NCT01746901|144242390|SUPERIORITY_OR_OTHER||LS Mean Difference|8.6||||0.3176|TWO_SIDED|95.0|-8.3|25.5|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||25.5|-8.3|0.3176
72365570|NCT01746901|144242390|SUPERIORITY_OR_OTHER||LS Mean Difference|4.0||||0.6423|TWO_SIDED|95.0|-12.9|20.9|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||20.9|-12.9|0.6423
72365571|NCT01746901|144242390|SUPERIORITY_OR_OTHER||LS Mean Difference|6.8||||0.4358|TWO_SIDED|95.0|-10.5|24.2|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||24.2|-10.5|0.4358
72365572|NCT01746901|144242390|SUPERIORITY_OR_OTHER||LS Mean Difference|11.7||||0.1789|TWO_SIDED|95.0|-5.4|28.9|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||28.9|-5.4|0.1789
72365573|NCT01746901|144242390|SUPERIORITY_OR_OTHER||LS Mean Difference|14.0||||0.1131|TWO_SIDED|95.0|-3.3|31.3|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||31.3|-3.3|0.1131
72365574|NCT01746901|144242390|SUPERIORITY_OR_OTHER||LS Mean Difference|4.6||||0.5965|TWO_SIDED|95.0|-12.6|21.8|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||21.8|-12.6|0.5965
72365575|NCT01746901|144242390|SUPERIORITY_OR_OTHER||LS Mean Difference|8.7||||0.3175|TWO_SIDED|95.0|-8.5|25.9|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||25.9|-8.5|0.3175
72365576|NCT01746901|144242390|SUPERIORITY_OR_OTHER||LS Mean Difference|3.9||||0.6551|TWO_SIDED|95.0|-13.3|21.0|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||21.0|-13.3|0.6551
72365577|NCT01746901|144242390|SUPERIORITY_OR_OTHER||LS Mean Difference|-45.3||||0.0354|TWO_SIDED|95.0|-87.5|-3.1|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-3.1|-87.5|0.0354
72365578|NCT01746901|144242390|SUPERIORITY_OR_OTHER||LS Mean Difference|55.2||||0.01|TWO_SIDED|95.0|13.4|97.0|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||97.0|13.4|0.0100
72365579|NCT01746901|144242390|SUPERIORITY_OR_OTHER||LS Mean Difference|13.2||||0.5379|TWO_SIDED|95.0|-29.0|55.4|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||55.4|-29.0|0.5379
72365580|NCT01746901|144242390|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.3||||0.8768|TWO_SIDED|95.0|-45.1|38.5|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||38.5|-45.1|0.8768
72365581|NCT01746901|144242390|SUPERIORITY_OR_OTHER||LS Mean Difference|8.1||||0.7031|TWO_SIDED|95.0|-33.8|49.9|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||49.9|-33.8|0.7031
72365582|NCT01746901|144242390|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.0||||0.8507|TWO_SIDED|95.0|-45.8|37.8|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||37.8|-45.8|0.8507
72365583|NCT01746901|144242390|SUPERIORITY_OR_OTHER||LS Mean Difference|-62.3||||0.0381|TWO_SIDED|95.0|-121.2|-3.5|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-3.5|-121.2|0.0381
72365584|NCT01746901|144242390|SUPERIORITY_OR_OTHER||LS Mean Difference|64.0||||0.0318|TWO_SIDED|95.0|5.7|122.3|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||122.3|5.7|0.0318
72365585|NCT01746901|144242390|SUPERIORITY_OR_OTHER||LS Mean Difference|15.2||||0.6095|TWO_SIDED|95.0|-43.6|74.1|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||74.1|-43.6|0.6095
72365586|NCT01746901|144242390|SUPERIORITY_OR_OTHER||LS Mean Difference|-13.6||||0.647|TWO_SIDED|95.0|-71.9|44.8|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||44.8|-71.9|0.6470
72365587|NCT01746901|144242390|SUPERIORITY_OR_OTHER||LS Mean Difference|7.0||||0.8136|TWO_SIDED|95.0|-51.4|65.4|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||65.4|-51.4|0.8136
72365588|NCT01746901|144242390|SUPERIORITY_OR_OTHER||LS Mean Difference|-12.6||||0.6699|TWO_SIDED|95.0|-71.0|45.7|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||45.7|-71.0|0.6699
72365589|NCT01746901|144242391|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.6||||0.1728|TWO_SIDED|95.0|-3.9|0.7|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||0.7|-3.9|0.1728
72365590|NCT01746901|144242391|SUPERIORITY_OR_OTHER||LS Mean Difference|1.3||||0.2616|TWO_SIDED|95.0|-1.0|3.6|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||3.6|-1.0|0.2616
72365591|NCT01746901|144242391|SUPERIORITY_OR_OTHER||LS Mean Difference|0.4||||0.7307|TWO_SIDED|95.0|-1.9|2.7|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||2.7|-1.9|0.7307
72365592|NCT01746901|144242391|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.7||||0.5473|TWO_SIDED|95.0|-3.0|1.6|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||1.6|-3.0|0.5473
72365593|NCT01746901|144242391|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.8||||0.4999|TWO_SIDED|95.0|-3.1|1.5|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||1.5|-3.1|0.4999
72365594|NCT01746901|144242391|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.7||||0.5592|TWO_SIDED|95.0|-3.0|1.6|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||1.6|-3.0|0.5592
72365595|NCT01746901|144242392|SUPERIORITY_OR_OTHER||LS Mean Difference|13.3||||0.0217|TWO_SIDED|95.0|2.0|24.6|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||24.6|2.0|0.0217
72365596|NCT01746901|144242392|SUPERIORITY_OR_OTHER||LS Mean Difference|3.4||||0.5513|TWO_SIDED|95.0|-7.8|14.6|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||14.6|-7.8|0.5513
72365597|NCT01746901|144242392|SUPERIORITY_OR_OTHER||LS Mean Difference|11.5||||0.0469|TWO_SIDED|95.0|0.2|22.8|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||22.8|0.2|0.0469
72365598|NCT01746901|144242392|SUPERIORITY_OR_OTHER||LS Mean Difference|5.2||||0.3604|TWO_SIDED|95.0|-6.0|16.4|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||16.4|-6.0|0.3604
72365599|NCT01746901|144242392|SUPERIORITY_OR_OTHER||LS Mean Difference|6.2||||0.2725|TWO_SIDED|95.0|-5.0|17.4|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||17.4|-5.0|0.2725
72365600|NCT01746901|144242392|SUPERIORITY_OR_OTHER||LS Mean Difference|5.4||||0.3461|TWO_SIDED|95.0|-5.8|16.6|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||16.6|-5.8|0.3461
72365601|NCT01746901|144242393|SUPERIORITY_OR_OTHER||LS Mean Difference|2.4||||0.1828|TWO_SIDED|95.0|-1.1|5.8|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||5.8|-1.1|0.1828
72365602|NCT01746901|144242393|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.5||||0.3908|TWO_SIDED|95.0|-5.0|1.9|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||1.9|-5.0|0.3908
72365603|NCT01746901|144242393|SUPERIORITY_OR_OTHER||LS Mean Difference|2.0||||0.2513|TWO_SIDED|95.0|-1.5|5.5|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||5.5|-1.5|0.2513
72365604|NCT01746901|144242393|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.2||||0.5035|TWO_SIDED|95.0|-4.6|2.3|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||2.3|-4.6|0.5035
72365605|NCT01746901|144242393|SUPERIORITY_OR_OTHER||LS Mean Difference|2.6||||0.1452|TWO_SIDED|95.0|-0.9|6.0|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||6.0|-0.9|0.1452
72365606|NCT01746901|144242393|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2||||0.9303|TWO_SIDED|95.0|-3.6|3.3|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||3.3|-3.6|0.9303
72365607|NCT01746901|144242393|SUPERIORITY_OR_OTHER||LS Mean Difference|8.8||||0.0283|TWO_SIDED|95.0|0.9|16.7|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||16.7|0.9|0.0283
72365608|NCT01746901|144242393|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.7||||0.4861|TWO_SIDED|95.0|-10.5|5.0|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||5.0|-10.5|0.4861
72365609|NCT01746901|144242393|SUPERIORITY_OR_OTHER||LS Mean Difference|5.3||||0.1809|TWO_SIDED|95.0|-2.5|13.2|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||13.2|-2.5|0.1809
72365610|NCT01746901|144242393|SUPERIORITY_OR_OTHER||LS Mean Difference|0.7||||0.856|TWO_SIDED|95.0|-7.1|8.5|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||8.5|-7.1|0.8560
72365611|NCT01746901|144242393|SUPERIORITY_OR_OTHER||LS Mean Difference|4.7||||0.2385|TWO_SIDED|95.0|-3.1|12.4|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||12.4|-3.1|0.2385
72365612|NCT01746901|144242393|SUPERIORITY_OR_OTHER||LS Mean Difference|3.7||||0.3479|TWO_SIDED|95.0|-4.1|11.5|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||11.5|-4.1|0.3479
72365613|NCT01746901|144242393|SUPERIORITY_OR_OTHER||LS Mean Difference|27.7||||0.0185|TWO_SIDED|95.0|4.7|50.6|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||50.6|4.7|0.0185
72365614|NCT01746901|144242393|SUPERIORITY_OR_OTHER||LS Mean Difference|6.9||||0.5471|TWO_SIDED|95.0|-15.8|29.7|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||29.7|-15.8|0.5471
72365615|NCT01746901|144242393|SUPERIORITY_OR_OTHER||LS Mean Difference|24.5||||0.0367|TWO_SIDED|95.0|1.5|47.4|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||47.4|1.5|0.0367
72365616|NCT01746901|144242393|SUPERIORITY_OR_OTHER||LS Mean Difference|10.1||||0.3797|TWO_SIDED|95.0|-12.6|32.9|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||32.9|-12.6|0.3797
72365617|NCT01746901|144242393|SUPERIORITY_OR_OTHER||LS Mean Difference|16.4||||0.1557|TWO_SIDED|95.0|-6.3|39.1|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||39.1|-6.3|0.1557
72365618|NCT01746901|144242393|SUPERIORITY_OR_OTHER||LS Mean Difference|12.2||||0.2904|TWO_SIDED|95.0|-10.5|34.9|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||34.9|-10.5|0.2904
72365619|NCT01746901|144242393|SUPERIORITY_OR_OTHER||LS Mean Difference|26.0||||0.0467|TWO_SIDED|95.0|0.4|51.6|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||51.6|0.4|0.0467
72365620|NCT01746901|144242393|SUPERIORITY_OR_OTHER||LS Mean Difference|10.7||||0.4056|TWO_SIDED|95.0|-14.6|36.0|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||36.0|-14.6|0.4056
72365621|NCT01746901|144242393|SUPERIORITY_OR_OTHER||LS Mean Difference|23.3||||0.0738|TWO_SIDED|95.0|-2.3|48.9|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||48.9|-2.3|0.0738
72365622|NCT01746901|144242393|SUPERIORITY_OR_OTHER||LS Mean Difference|13.4||||0.2987|TWO_SIDED|95.0|-12.0|38.7|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||38.7|-12.0|0.2987
72365623|NCT01746901|144242393|SUPERIORITY_OR_OTHER||LS Mean Difference|22.9||||0.0763|TWO_SIDED|95.0|-2.4|48.2|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||48.2|-2.4|0.0763
72365624|NCT01746901|144242393|SUPERIORITY_OR_OTHER||LS Mean Difference|12.3||||0.3396|TWO_SIDED|95.0|-13.1|37.6|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||37.6|-13.1|0.3396
72431732|NCT00495469|144375418|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.24||||0.185|TWO_SIDED|95.0|-0.12|0.6||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change = Baseline + Treatment||||0.60|-0.12|0.185
72431733|NCT00495469|144375418|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.03||||0.863|TWO_SIDED|95.0|-0.32|0.39||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change = Baseline + Treatment||||0.39|-0.32|0.863
72365625|NCT01746901|144242393|SUPERIORITY_OR_OTHER||LS Mean Difference|-33.2||||0.2425|TWO_SIDED|95.0|-89.1|22.7|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||22.7|-89.1|0.2425
72365626|NCT01746901|144242393|SUPERIORITY_OR_OTHER||LS Mean Difference|62.1||||0.0281|TWO_SIDED|95.0|6.8|117.5|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||117.5|6.8|0.0281
72365627|NCT01746901|144242393|SUPERIORITY_OR_OTHER||LS Mean Difference|22.9||||0.4189|TWO_SIDED|95.0|-33.0|78.8|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||78.8|-33.0|0.4189
72365628|NCT01746901|144242393|SUPERIORITY_OR_OTHER||LS Mean Difference|6.0||||0.831|TWO_SIDED|95.0|-49.4|61.4|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||61.4|-49.4|0.8310
72365629|NCT01746901|144242393|SUPERIORITY_OR_OTHER||LS Mean Difference|34.8||||0.2161|TWO_SIDED|95.0|-20.6|90.1|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||90.1|-20.6|0.2161
72365630|NCT01746901|144242393|SUPERIORITY_OR_OTHER||LS Mean Difference|3.9||||0.8905|TWO_SIDED|95.0|-51.5|59.2|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||59.2|-51.5|0.8905
72365631|NCT01746901|144242393|SUPERIORITY_OR_OTHER||LS Mean Difference|-51.8||||0.1597|TWO_SIDED|95.0|-124.2|20.6|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||20.6|-124.2|0.1597
72365632|NCT01746901|144242393|SUPERIORITY_OR_OTHER||LS Mean Difference|70.9||||0.0525|TWO_SIDED|95.0|-0.8|142.6|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||142.6|-0.8|0.0525
72365633|NCT01746901|144242393|SUPERIORITY_OR_OTHER||LS Mean Difference|23.1||||0.5294|TWO_SIDED|95.0|-49.3|95.4|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||95.4|-49.3|0.5294
72365634|NCT01746901|144242393|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.0||||0.9126|TWO_SIDED|95.0|-75.7|67.7|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||67.7|-75.7|0.9126
72365635|NCT01746901|144242393|SUPERIORITY_OR_OTHER||LS Mean Difference|34.6||||0.3418|TWO_SIDED|95.0|-37.1|106.3|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||106.3|-37.1|0.3418
72365636|NCT01746901|144242393|SUPERIORITY_OR_OTHER||LS Mean Difference|-5.3||||0.8833|TWO_SIDED|95.0|-77.0|66.4|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||66.4|-77.0|0.8833
72365637|NCT01746901|144242394|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.6||||0.0041|TWO_SIDED|95.0|-6.1|-1.2|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-1.2|-6.1|0.0041
72365638|NCT01746901|144242394|SUPERIORITY_OR_OTHER||LS Mean Difference|4.3||||0.0006|TWO_SIDED|95.0|1.9|6.8|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||6.8|1.9|0.0006
72365639|NCT01746901|144242394|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2||||0.8765|TWO_SIDED|95.0|-2.7|2.3|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||2.3|-2.7|0.8765
72365640|NCT01746901|144242394|SUPERIORITY_OR_OTHER||LS Mean Difference|0.9||||0.4746|TWO_SIDED|95.0|-1.6|3.3|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||3.3|-1.6|0.4746
72365641|NCT01746901|144242394|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.9||||0.4607|TWO_SIDED|95.0|-3.3|1.5|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||1.5|-3.3|0.4607
72365642|NCT01746901|144242394|SUPERIORITY_OR_OTHER||LS Mean Difference|1.5||||0.2316|TWO_SIDED|95.0|-1.0|3.9|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||3.9|-1.0|0.2316
72365643|NCT01746901|144242395|SUPERIORITY_OR_OTHER||LS Mean Difference|38.8|||<|0.0001|TWO_SIDED|95.0|26.4|51.3|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||51.3|26.4|<0.0001
72365644|NCT01746901|144242395|SUPERIORITY_OR_OTHER||LS Mean Difference|15.8||||0.0136|TWO_SIDED|95.0|3.3|28.3|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||28.3|3.3|0.0136
72365645|NCT01746901|144242395|SUPERIORITY_OR_OTHER||LS Mean Difference|18.5||||0.0039|TWO_SIDED|95.0|6.1|31.0|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||31.0|6.1|0.0039
72365646|NCT01746901|144242395|SUPERIORITY_OR_OTHER||LS Mean Difference|36.1|||<|0.0001|TWO_SIDED|95.0|23.6|48.5|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||48.5|23.6|<0.0001
72365647|NCT01746901|144242395|SUPERIORITY_OR_OTHER||LS Mean Difference|15.4||||0.0157|TWO_SIDED|95.0|2.9|27.8|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||27.8|2.9|0.0157
72365648|NCT01746901|144242395|SUPERIORITY_OR_OTHER||LS Mean Difference|32.9|||<|0.0001|TWO_SIDED|95.0|20.5|45.3|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||45.3|20.5|<0.0001
72365649|NCT01746901|144242396|SUPERIORITY_OR_OTHER||LS Mean Difference|12.5|||<|0.0001|TWO_SIDED|95.0|6.4|18.6|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||18.6|6.4|<0.0001
72365650|NCT01746901|144242396|SUPERIORITY_OR_OTHER||LS Mean Difference|3.5||||0.255|TWO_SIDED|95.0|-2.6|9.6|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||9.6|-2.6|0.2550
72365651|NCT01746901|144242396|SUPERIORITY_OR_OTHER||LS Mean Difference|10.4||||0.001|TWO_SIDED|95.0|4.3|16.4|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||16.4|4.3|0.0010
72365652|NCT01746901|144242396|SUPERIORITY_OR_OTHER||LS Mean Difference|5.7||||0.0667|TWO_SIDED|95.0|-0.4|11.8|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||11.8|-0.4|0.0667
72365653|NCT01746901|144242396|SUPERIORITY_OR_OTHER||LS Mean Difference|8.3||||0.0075|TWO_SIDED|95.0|2.3|14.4|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||14.4|2.3|0.0075
72365654|NCT01746901|144242396|SUPERIORITY_OR_OTHER||LS Mean Difference|4.6||||0.1354|TWO_SIDED|95.0|-1.5|10.7|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||10.7|-1.5|0.1354
72365655|NCT01746901|144242396|SUPERIORITY_OR_OTHER||LS Mean Difference|50.9|||<|0.0001|TWO_SIDED|95.0|34.2|67.5|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||67.5|34.2|<0.0001
72365656|NCT01746901|144242396|SUPERIORITY_OR_OTHER||LS Mean Difference|7.3||||0.3905|TWO_SIDED|95.0|-9.4|24.0|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||24.0|-9.4|0.3905
72365657|NCT01746901|144242396|SUPERIORITY_OR_OTHER||LS Mean Difference|28.6||||0.0009|TWO_SIDED|95.0|11.9|45.3|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||45.3|11.9|0.0009
72365658|NCT01746901|144242396|SUPERIORITY_OR_OTHER||LS Mean Difference|29.6||||0.0006|TWO_SIDED|95.0|12.9|46.3|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||46.3|12.9|0.0006
72365659|NCT01746901|144242396|SUPERIORITY_OR_OTHER||LS Mean Difference|22.9||||0.0072|TWO_SIDED|95.0|6.3|39.5|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||39.5|6.3|0.0072
72365660|NCT01746901|144242396|SUPERIORITY_OR_OTHER||LS Mean Difference|25.0||||0.0035|TWO_SIDED|95.0|8.4|41.6|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||41.6|8.4|0.0035
72365661|NCT01746901|144242396|SUPERIORITY_OR_OTHER||LS Mean Difference|248.4|||<|0.0001|TWO_SIDED|95.0|188.6|308.3|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||308.3|188.6|<0.0001
72365662|NCT01746901|144242396|SUPERIORITY_OR_OTHER||LS Mean Difference|68.2||||0.0263|TWO_SIDED|95.0|8.2|128.2|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||128.2|8.2|0.0263
72365663|NCT01746901|144242396|SUPERIORITY_OR_OTHER||LS Mean Difference|151.2|||<|0.0001|TWO_SIDED|95.0|91.3|211.1|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||211.1|91.3|<0.0001
72365664|NCT01746901|144242396|SUPERIORITY_OR_OTHER||LS Mean Difference|165.4|||<|0.0001|TWO_SIDED|95.0|105.6|225.3|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||225.3|105.6|<0.0001
72365665|NCT01746901|144242396|SUPERIORITY_OR_OTHER||LS Mean Difference|97.9||||0.0015|TWO_SIDED|95.0|38.3|157.6|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||157.6|38.3|0.0015
72365666|NCT01746901|144242396|SUPERIORITY_OR_OTHER||LS Mean Difference|138.4|||<|0.0001|TWO_SIDED|95.0|78.7|198.2|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||198.2|78.7|<0.0001
72365667|NCT01746901|144242396|SUPERIORITY_OR_OTHER||LS Mean Difference|241.3|||<|0.0001|TWO_SIDED|95.0|162.8|319.9|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||319.9|162.8|<0.0001
72365668|NCT01746901|144242396|SUPERIORITY_OR_OTHER||LS Mean Difference|121.1||||0.0028|TWO_SIDED|95.0|42.4|199.9|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||199.9|42.4|0.0028
72365669|NCT01746901|144242396|SUPERIORITY_OR_OTHER||LS Mean Difference|164.4|||<|0.0001|TWO_SIDED|95.0|85.8|243.1|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||243.1|85.8|<0.0001
72365670|NCT01746901|144242396|SUPERIORITY_OR_OTHER||LS Mean Difference|198.0|||<|0.0001|TWO_SIDED|95.0|119.4|276.6|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||276.6|119.4|<0.0001
72365671|NCT01746901|144242396|SUPERIORITY_OR_OTHER||LS Mean Difference|111.1||||0.0057|TWO_SIDED|95.0|32.8|189.4|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||189.4|32.8|0.0057
72365672|NCT01746901|144242396|SUPERIORITY_OR_OTHER||LS Mean Difference|168.1|||<|0.0001|TWO_SIDED|95.0|89.7|246.6|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||246.6|89.7|<0.0001
72431734|NCT00495469|144375419|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.15||||0.348|TWO_SIDED|95.0|-0.46|0.16||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change = Baseline + Treatment||||0.16|-0.46|0.348
72365673|NCT01746901|144242396|SUPERIORITY_OR_OTHER||LS Mean Difference|128.4||||0.036|TWO_SIDED|95.0|8.5|248.3|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||248.3|8.5|0.0360
72365674|NCT01746901|144242396|SUPERIORITY_OR_OTHER||LS Mean Difference|221.5||||0.0004|TWO_SIDED|95.0|101.2|341.7|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||341.7|101.2|0.0004
72365675|NCT01746901|144242396|SUPERIORITY_OR_OTHER||LS Mean Difference|126.7||||0.0388|TWO_SIDED|95.0|6.6|246.8|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||246.8|6.6|0.0388
72365676|NCT01746901|144242396|SUPERIORITY_OR_OTHER||LS Mean Difference|223.2||||0.0003|TWO_SIDED|95.0|103.2|343.2|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||343.2|103.2|0.0003
72365677|NCT01746901|144242396|SUPERIORITY_OR_OTHER||LS Mean Difference|107.2||||0.0787|TWO_SIDED|95.0|-12.4|226.8|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||226.8|-12.4|0.0787
72365678|NCT01746901|144242396|SUPERIORITY_OR_OTHER||LS Mean Difference|181.3||||0.0033|TWO_SIDED|95.0|61.5|301.0|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||301.0|61.5|0.0033
72365679|NCT01746901|144242396|SUPERIORITY_OR_OTHER||LS Mean Difference|96.1||||0.1688|TWO_SIDED|95.0|-41.2|233.3|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||233.3|-41.2|0.1688
72365680|NCT01746901|144242396|SUPERIORITY_OR_OTHER||LS Mean Difference|220.3||||0.0019|TWO_SIDED|95.0|82.6|358.0|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||358.0|82.6|0.0019
72365681|NCT01746901|144242396|SUPERIORITY_OR_OTHER||LS Mean Difference|106.0||||0.1298|TWO_SIDED|95.0|-31.5|243.5|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||243.5|-31.5|0.1298
72365682|NCT01746901|144242396|SUPERIORITY_OR_OTHER||LS Mean Difference|210.4||||0.0029|TWO_SIDED|95.0|73.0|347.8|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||347.8|73.0|0.0029
72365683|NCT01746901|144242396|SUPERIORITY_OR_OTHER||LS Mean Difference|108.7||||0.1189|TWO_SIDED|95.0|-28.3|245.7|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||245.7|-28.3|0.1189
72365684|NCT01746901|144242396|SUPERIORITY_OR_OTHER||LS Mean Difference|153.6||||0.0284|TWO_SIDED|95.0|16.4|290.8|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||290.8|16.4|0.0284
72365685|NCT01746901|144242397|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.8||||0.0327|TWO_SIDED|95.0|-3.4|-0.1|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-0.1|-3.4|0.0327
72365686|NCT01746901|144242397|SUPERIORITY_OR_OTHER||LS Mean Difference|2.6||||0.0019|TWO_SIDED|95.0|1.0|4.2|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||4.2|1.0|0.0019
72365687|NCT01746901|144242397|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3||||0.7508|TWO_SIDED|95.0|-1.9|1.4|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||1.4|-1.9|0.7508
72365688|NCT01746901|144242397|SUPERIORITY_OR_OTHER||LS Mean Difference|1.1||||0.1868|TWO_SIDED|95.0|-0.5|2.7|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||2.7|-0.5|0.1868
72365689|NCT01746901|144242397|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0||||0.9944|TWO_SIDED|95.0|-1.6|1.6|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||1.6|-1.6|0.9944
72365690|NCT01746901|144242397|SUPERIORITY_OR_OTHER||LS Mean Difference|1.0||||0.2322|TWO_SIDED|95.0|-0.6|2.6|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||2.6|-0.6|0.2322
72365691|NCT01746901|144242398|SUPERIORITY_OR_OTHER||LS Mean Difference|28.2|||<|0.0001|TWO_SIDED|95.0|16.8|39.6|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||39.6|16.8|<0.0001
72365692|NCT01746901|144242398|SUPERIORITY_OR_OTHER||LS Mean Difference|8.4||||0.1421|TWO_SIDED|95.0|-2.8|19.6|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||19.6|-2.8|0.1421
72365693|NCT01746901|144242398|SUPERIORITY_OR_OTHER||LS Mean Difference|20.9||||0.0004|TWO_SIDED|95.0|9.5|32.2|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||32.2|9.5|0.0004
72365694|NCT01746901|144242398|SUPERIORITY_OR_OTHER||LS Mean Difference|15.8||||0.0064|TWO_SIDED|95.0|4.5|27.0|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||27.0|4.5|0.0064
72365695|NCT01746901|144242398|SUPERIORITY_OR_OTHER||LS Mean Difference|7.4||||0.1974|TWO_SIDED|95.0|-3.9|18.6|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||18.6|-3.9|0.1974
72365696|NCT01746901|144242398|SUPERIORITY_OR_OTHER||LS Mean Difference|19.5||||0.0008|TWO_SIDED|95.0|8.3|30.8|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||30.8|8.3|0.0008
72365697|NCT01746901|144242399|SUPERIORITY_OR_OTHER||LS Mean Difference|12.2|||<|0.0001|TWO_SIDED|95.0|7.1|17.4|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||17.4|7.1|<0.0001
72365698|NCT01746901|144242399|SUPERIORITY_OR_OTHER||LS Mean Difference|1.0||||0.6868|TWO_SIDED|95.0|-4.1|6.2|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||6.2|-4.1|0.6868
72365699|NCT01746901|144242399|SUPERIORITY_OR_OTHER||LS Mean Difference|7.3||||0.0058|TWO_SIDED|95.0|2.2|12.5|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||12.5|2.2|0.0058
72365700|NCT01746901|144242399|SUPERIORITY_OR_OTHER||LS Mean Difference|5.9||||0.0229|TWO_SIDED|95.0|0.8|11.1|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||11.1|0.8|0.0229
72365701|NCT01746901|144242399|SUPERIORITY_OR_OTHER||LS Mean Difference|3.2||||0.2168|TWO_SIDED|95.0|-1.9|8.3|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||8.3|-1.9|0.2168
72365702|NCT01746901|144242399|SUPERIORITY_OR_OTHER||LS Mean Difference|6.8||||0.0096|TWO_SIDED|95.0|1.7|11.9|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||11.9|1.7|0.0096
72365703|NCT01746901|144242399|SUPERIORITY_OR_OTHER||LS Mean Difference|33.0|||<|0.0001|TWO_SIDED|95.0|20.0|45.9|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||45.9|20.0|<0.0001
72365704|NCT01746901|144242399|SUPERIORITY_OR_OTHER||LS Mean Difference|1.6||||0.8009|TWO_SIDED|95.0|-11.2|14.4|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||14.4|-11.2|0.8009
72365705|NCT01746901|144242399|SUPERIORITY_OR_OTHER||LS Mean Difference|17.4||||0.0086|TWO_SIDED|95.0|4.5|30.3|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||30.3|4.5|0.0086
72365706|NCT01746901|144242399|SUPERIORITY_OR_OTHER||LS Mean Difference|17.2||||0.0089|TWO_SIDED|95.0|4.4|30.0|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||30.0|4.4|0.0089
72365707|NCT01746901|144242399|SUPERIORITY_OR_OTHER||LS Mean Difference|5.2||||0.4224|TWO_SIDED|95.0|-7.6|18.0|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||18.0|-7.6|0.4224
72365708|NCT01746901|144242399|SUPERIORITY_OR_OTHER||LS Mean Difference|22.6||||0.0006|TWO_SIDED|95.0|9.8|35.5|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||35.5|9.8|0.0006
72365709|NCT01746901|144242399|SUPERIORITY_OR_OTHER||LS Mean Difference|96.1|||<|0.0001|TWO_SIDED|95.0|57.9|134.2|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||134.2|57.9|<0.0001
72365710|NCT01746901|144242399|SUPERIORITY_OR_OTHER||LS Mean Difference|21.9||||0.253|TWO_SIDED|95.0|-15.8|59.7|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||59.7|-15.8|0.2530
72365711|NCT01746901|144242399|SUPERIORITY_OR_OTHER||LS Mean Difference|78.6|||<|0.0001|TWO_SIDED|95.0|40.5|116.8|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||116.8|40.5|<0.0001
72365712|NCT01746901|144242399|SUPERIORITY_OR_OTHER||LS Mean Difference|39.3||||0.0414|TWO_SIDED|95.0|1.6|77.1|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||77.1|1.6|0.0414
72365713|NCT01746901|144242399|SUPERIORITY_OR_OTHER||LS Mean Difference|28.9||||0.1329|TWO_SIDED|95.0|-8.9|66.6|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||66.6|-8.9|0.1329
72365714|NCT01746901|144242399|SUPERIORITY_OR_OTHER||LS Mean Difference|45.5||||0.0187|TWO_SIDED|95.0|7.7|83.2|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||83.2|7.7|0.0187
72365715|NCT01746901|144242399|SUPERIORITY_OR_OTHER||LS Mean Difference|76.9||||0.0009|TWO_SIDED|95.0|31.9|121.9|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||121.9|31.9|0.0009
72365716|NCT01746901|144242399|SUPERIORITY_OR_OTHER||LS Mean Difference|45.4||||0.0456|TWO_SIDED|95.0|0.9|89.9|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||89.9|0.9|0.0456
72365717|NCT01746901|144242399|SUPERIORITY_OR_OTHER||LS Mean Difference|82.8||||0.0004|TWO_SIDED|95.0|37.8|127.7|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||127.7|37.8|0.0004
72365718|NCT01746901|144242399|SUPERIORITY_OR_OTHER||LS Mean Difference|39.6||||0.0812|TWO_SIDED|95.0|-5.0|84.1|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||84.1|-5.0|0.0812
72365719|NCT01746901|144242399|SUPERIORITY_OR_OTHER||LS Mean Difference|35.5||||0.1174|TWO_SIDED|95.0|-9.0|80.0|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||80.0|-9.0|0.1174
72365720|NCT01746901|144242399|SUPERIORITY_OR_OTHER||LS Mean Difference|46.1||||0.0427|TWO_SIDED|95.0|1.5|90.6|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||90.6|1.5|0.0427
72365721|NCT01746901|144242399|SUPERIORITY_OR_OTHER||LS Mean Difference|3.0||||0.9318|TWO_SIDED|95.0|-66.9|73.0|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||73.0|-66.9|0.9318
72365722|NCT01746901|144242399|SUPERIORITY_OR_OTHER||LS Mean Difference|110.4||||0.002|TWO_SIDED|95.0|41.2|179.6|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||179.6|41.2|0.0020
72365723|NCT01746901|144242399|SUPERIORITY_OR_OTHER||LS Mean Difference|81.5||||0.0226|TWO_SIDED|95.0|11.6|151.4|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||151.4|11.6|0.0226
72365724|NCT01746901|144242399|SUPERIORITY_OR_OTHER||LS Mean Difference|32.0||||0.3629|TWO_SIDED|95.0|-37.3|101.2|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||101.2|-37.3|0.3629
72365725|NCT01746901|144242399|SUPERIORITY_OR_OTHER||LS Mean Difference|35.9||||0.3077|TWO_SIDED|95.0|-33.4|105.1|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||105.1|-33.4|0.3077
72365726|NCT01746901|144242399|SUPERIORITY_OR_OTHER||LS Mean Difference|39.1||||0.2662|TWO_SIDED|95.0|-30.1|108.4|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||108.4|-30.1|0.2662
72365727|NCT01746901|144242399|SUPERIORITY_OR_OTHER||LS Mean Difference|-11.4||||0.7875|TWO_SIDED|95.0|-94.7|71.9|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||71.9|-94.7|0.7875
72365728|NCT01746901|144242399|SUPERIORITY_OR_OTHER||LS Mean Difference|115.0||||0.0066|TWO_SIDED|95.0|32.6|197.4|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||197.4|32.6|0.0066
72365729|NCT01746901|144242399|SUPERIORITY_OR_OTHER||LS Mean Difference|81.7||||0.054|TWO_SIDED|95.0|-1.4|164.9|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||164.9|-1.4|0.0540
72365730|NCT01746901|144242399|SUPERIORITY_OR_OTHER||LS Mean Difference|21.8||||0.6014|TWO_SIDED|95.0|-60.6|104.3|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||104.3|-60.6|0.6014
72365731|NCT01746901|144242399|SUPERIORITY_OR_OTHER||LS Mean Difference|36.1||||0.3885|TWO_SIDED|95.0|-46.3|118.5|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||118.5|-46.3|0.3885
72365732|NCT01746901|144242399|SUPERIORITY_OR_OTHER||LS Mean Difference|29.5||||0.4801|TWO_SIDED|95.0|-52.9|112.0|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||112.0|-52.9|0.4801
72365733|NCT01746901|144242400|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.6||||0.5494|TWO_SIDED|95.0|-2.5|1.4|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||1.4|-2.5|0.5494
72365734|NCT01746901|144242400|SUPERIORITY_OR_OTHER||LS Mean Difference|1.8||||0.0626|TWO_SIDED|95.0|-0.1|3.8|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||3.8|-0.1|0.0626
72365735|NCT01746901|144242400|SUPERIORITY_OR_OTHER||LS Mean Difference|0.4||||0.7216|TWO_SIDED|95.0|-1.6|2.3|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||2.3|-1.6|0.7216
72365736|NCT01746901|144242400|SUPERIORITY_OR_OTHER||LS Mean Difference|0.9||||0.3647|TWO_SIDED|95.0|-1.0|2.8|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||2.8|-1.0|0.3647
72365737|NCT01746901|144242400|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.7||||0.4456|TWO_SIDED|95.0|-2.7|1.2|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||1.2|-2.7|0.4456
72365738|NCT01746901|144242400|SUPERIORITY_OR_OTHER||LS Mean Difference|1.9||||0.05|TWO_SIDED|95.0|0.0|3.9|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||3.9|0.0|0.0500
72365739|NCT01746901|144242401|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.51|||<|0.0001|TWO_SIDED|95.0|-0.69|-0.34|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-0.34|-0.69|<0.0001
72365740|NCT01746901|144242401|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.69|||<|0.0001|TWO_SIDED|95.0|-1.86|-1.52|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-1.52|-1.86|<0.0001
72365741|NCT01746901|144242401|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.8|||<|0.0001|TWO_SIDED|95.0|-0.97|-0.63|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-0.63|-0.97|<0.0001
72365742|NCT01746901|144242401|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.4|||<|0.0001|TWO_SIDED|95.0|-1.58|-1.23|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-1.23|-1.58|<0.0001
72365743|NCT01746901|144242401|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.74|||<|0.0001|TWO_SIDED|95.0|-0.91|-0.56|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-0.56|-0.91|<0.0001
72365744|NCT01746901|144242401|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.29|||<|0.0001|TWO_SIDED|95.0|-1.46|-1.11|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-1.11|-1.46|<0.0001
72365745|NCT01746901|144242402|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.59|||<|0.0001|TWO_SIDED|95.0|-1.75|-1.42|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-1.42|-1.75|<0.0001
72365746|NCT01746901|144242402|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.08||||0.3309|TWO_SIDED|95.0|-0.24|0.08|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||0.08|-0.24|0.3309
72365747|NCT01746901|144242402|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.58|||<|0.0001|TWO_SIDED|95.0|-0.74|-0.42|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-0.42|-0.74|<0.0001
72365748|NCT01746901|144242402|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.09|||<|0.0001|TWO_SIDED|95.0|-1.25|-0.92|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-0.92|-1.25|<0.0001
72365749|NCT01746901|144242402|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.42|||<|0.0001|TWO_SIDED|95.0|-0.59|-0.26|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-0.26|-0.59|<0.0001
72365750|NCT01746901|144242402|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.04|||<|0.0001|TWO_SIDED|95.0|-1.21|-0.88|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-0.88|-1.21|<0.0001
72431735|NCT00495469|144375419|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.01||||0.952|TWO_SIDED|95.0|-0.33|0.31||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change = Baseline + Treatment||||0.31|-0.33|0.952
72431736|NCT00495469|144375419|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.1||||0.523|TWO_SIDED|95.0|-0.21|0.42||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change = Baseline + Treatment||||0.42|-0.21|0.523
72365751|NCT01746901|144242402|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.03|||<|0.0001|TWO_SIDED|95.0|-4.37|-3.69|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-3.69|-4.37|<0.0001
72365752|NCT01746901|144242402|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2||||0.2475|TWO_SIDED|95.0|-0.54|0.14|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||0.14|-0.54|0.2475
72365753|NCT01746901|144242402|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.61|||<|0.0001|TWO_SIDED|95.0|-1.96|-1.27|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-1.27|-1.96|<0.0001
72365754|NCT01746901|144242402|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.62|||<|0.0001|TWO_SIDED|95.0|-2.96|-2.27|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-2.27|-2.96|<0.0001
72365755|NCT01746901|144242402|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.34|||<|0.0001|TWO_SIDED|95.0|-1.68|-1.0|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-1.00|-1.68|<0.0001
72365756|NCT01746901|144242402|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.42|||<|0.0001|TWO_SIDED|95.0|-2.76|-2.08|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-2.08|-2.76|<0.0001
72365757|NCT01746901|144242402|SUPERIORITY_OR_OTHER||LS Mean Difference|-11.91|||<|0.0001|TWO_SIDED|95.0|-13.21|-10.6|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-10.60|-13.21|<0.0001
72365758|NCT01746901|144242402|SUPERIORITY_OR_OTHER||LS Mean Difference|-7.23|||<|0.0001|TWO_SIDED|95.0|-8.54|-5.93|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-5.93|-8.54|<0.0001
72365759|NCT01746901|144242402|SUPERIORITY_OR_OTHER||LS Mean Difference|-7.9|||<|0.0001|TWO_SIDED|95.0|-9.2|-6.59|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-6.59|-9.20|<0.0001
72365760|NCT01746901|144242402|SUPERIORITY_OR_OTHER||LS Mean Difference|-11.24|||<|0.0001|TWO_SIDED|95.0|-12.55|-9.94|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-9.94|-12.55|<0.0001
72365761|NCT01746901|144242402|SUPERIORITY_OR_OTHER||LS Mean Difference|-6.35|||<|0.0001|TWO_SIDED|95.0|-7.65|-5.05|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-5.05|-7.65|<0.0001
72365762|NCT01746901|144242402|SUPERIORITY_OR_OTHER||LS Mean Difference|-10.36|||<|0.0001|TWO_SIDED|95.0|-11.67|-9.05|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-9.05|-11.67|<0.0001
72365763|NCT01746901|144242402|SUPERIORITY_OR_OTHER||LS Mean Difference|-11.37|||<|0.0001|TWO_SIDED|95.0|-13.16|-9.58|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-9.58|-13.16|<0.0001
72365764|NCT01746901|144242402|SUPERIORITY_OR_OTHER||LS Mean Difference|-16.07|||<|0.0001|TWO_SIDED|95.0|-17.86|-14.28|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-14.28|-17.86|<0.0001
72365765|NCT01746901|144242402|SUPERIORITY_OR_OTHER||LS Mean Difference|-11.73|||<|0.0001|TWO_SIDED|95.0|-13.53|-9.93|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-9.93|-13.53|<0.0001
72431737|NCT00495469|144375419|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.02||||0.889|TWO_SIDED|95.0|-0.34|0.29||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change = Baseline + Treatment||||0.29|-0.34|0.889
72365766|NCT01746901|144242402|SUPERIORITY_OR_OTHER||LS Mean Difference|-15.71|||<|0.0001|TWO_SIDED|95.0|-17.51|-13.91|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-13.91|-17.51|<0.0001
72365767|NCT01746901|144242402|SUPERIORITY_OR_OTHER||LS Mean Difference|-8.88|||<|0.0001|TWO_SIDED|95.0|-10.67|-7.09|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-7.09|-10.67|<0.0001
72365768|NCT01746901|144242402|SUPERIORITY_OR_OTHER||LS Mean Difference|-14.19|||<|0.0001|TWO_SIDED|95.0|-15.99|-12.39|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-12.39|-15.99|<0.0001
72431738|NCT00495469|144375419|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.25||||0.124|TWO_SIDED|95.0|-0.07|0.56||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change = Baseline + Treatment||||0.56|-0.07|0.124
72431739|NCT00495469|144375419|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.09||||0.581|TWO_SIDED|95.0|-0.22|0.4||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change = Baseline + Treatment||||0.40|-0.22|0.581
72431740|NCT00495469|144375420|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.02||||0.518|TWO_SIDED|95.0|-0.05|0.1||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change = Baseline + Treatment||||0.10|-0.05|0.518
72431741|NCT00495469|144375420|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.04||||0.352|TWO_SIDED|95.0|-0.04|0.11||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change = Baseline + Treatment||||0.11|-0.04|0.352
72431742|NCT00495469|144375420|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.08||||0.026|TWO_SIDED|95.0|0.01|0.16||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change = Baseline + Treatment||||0.16|0.01|0.026
72431743|NCT00495469|144375420|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.07||||0.069|TWO_SIDED|95.0|-0.01|0.14||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change = Baseline + Treatment||||0.14|-0.01|0.069
72431744|NCT00495469|144375420|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.06||||0.154|TWO_SIDED|95.0|-0.02|0.13||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change = Baseline + Treatment||||0.13|-0.02|0.154
72365769|NCT01746901|144242402|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.26||||0.8784|TWO_SIDED|95.0|-3.63|3.11|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||3.11|-3.63|0.8784
72365770|NCT01746901|144242402|SUPERIORITY_OR_OTHER||LS Mean Difference|-41.66|||<|0.0001|TWO_SIDED|95.0|-45.02|-38.29|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-38.29|-45.02|<0.0001
72365771|NCT01746901|144242402|SUPERIORITY_OR_OTHER||LS Mean Difference|-19.63|||<|0.0001|TWO_SIDED|95.0|-23.01|-16.25|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-16.25|-23.01|<0.0001
72365772|NCT01746901|144242402|SUPERIORITY_OR_OTHER||LS Mean Difference|-22.28|||<|0.0001|TWO_SIDED|95.0|-25.67|-18.9|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-18.90|-25.67|<0.0001
72365773|NCT01746901|144242402|SUPERIORITY_OR_OTHER||LS Mean Difference|-12.5|||<|0.0001|TWO_SIDED|95.0|-15.86|-9.14|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-9.14|-15.86|<0.0001
72365774|NCT01746901|144242402|SUPERIORITY_OR_OTHER||LS Mean Difference|-20.59|||<|0.0001|TWO_SIDED|95.0|-23.98|-17.21|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-17.21|-23.98|<0.0001
72431745|NCT00495469|144375420|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.11||||0.005|TWO_SIDED|95.0|0.03|0.18||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change = Baseline + Treatment||||0.18|0.03|0.005
72431746|NCT00495469|144375421|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.25||||0.143|TWO_SIDED|95.0|-0.58|0.08||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change = Baseline + Treatment||||0.08|-0.58|0.143
72431747|NCT00495469|144375421|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.12||||0.495|TWO_SIDED|95.0|-0.46|0.22||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change = Baseline + Treatment||||0.22|-0.46|0.495
72431748|NCT00495469|144375421|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.19||||0.261|TWO_SIDED|95.0|-0.52|0.14||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change = Baseline + Treatment||||0.14|-0.52|0.261
72431749|NCT00495469|144375421|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.13||||0.446|TWO_SIDED|95.0|-0.46|0.2||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change = Baseline + Treatment||||0.20|-0.46|0.446
72431750|NCT00495469|144375421|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.05||||0.783|TWO_SIDED|95.0|-0.29|0.38||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change = Baseline + Treatment||||0.38|-0.29|0.783
72431751|NCT00495469|144375421|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.13||||0.454|TWO_SIDED|95.0|-0.46|0.21||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change = Baseline + Treatment||||0.21|-0.46|0.454
72431752|NCT00495469|144375422|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.19||||0.363|TWO_SIDED|95.0|-0.59|0.22||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change = Baseline + Treatment||||0.22|-0.59|0.363
72431753|NCT00495469|144375422|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.34||||0.111|TWO_SIDED|95.0|-0.76|0.08||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change = Baseline + Treatment||||0.08|-0.76|0.111
72431754|NCT00495469|144375422|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.36||||0.08|TWO_SIDED|95.0|-0.77|0.04||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change = Baseline + Treatment||||0.04|-0.77|0.080
72431755|NCT00495469|144375422|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.23||||0.267|TWO_SIDED|95.0|-0.64|0.18||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change = Baseline + Treatment||||0.18|-0.64|0.267
72431756|NCT00495469|144375422|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.13||||0.549|TWO_SIDED|95.0|-0.54|0.29||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change = Baseline + Treatment||||0.29|-0.54|0.549
72431757|NCT00495469|144375422|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.4||||0.056|TWO_SIDED|95.0|-0.81|0.01||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change = Baseline + Treatment||||0.01|-0.81|0.056
72365775|NCT01746901|144242402|SUPERIORITY_OR_OTHER||LS Mean Difference|10.64|||<|0.0001|TWO_SIDED|95.0|5.75|15.54|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||15.54|5.75|<0.0001
72365776|NCT01746901|144242402|SUPERIORITY_OR_OTHER||LS Mean Difference|-57.74|||<|0.0001|TWO_SIDED|95.0|-62.63|-52.85|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-52.85|-62.63|<0.0001
72365777|NCT01746901|144242402|SUPERIORITY_OR_OTHER||LS Mean Difference|-22.18|||<|0.0001|TWO_SIDED|95.0|-27.09|-17.27|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-17.27|-27.09|<0.0001
72365778|NCT01746901|144242402|SUPERIORITY_OR_OTHER||LS Mean Difference|-24.91|||<|0.0001|TWO_SIDED|95.0|-29.83|-20.0|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-20.00|-29.83|<0.0001
72365779|NCT01746901|144242402|SUPERIORITY_OR_OTHER||LS Mean Difference|-13.53|||<|0.0001|TWO_SIDED|95.0|-18.41|-8.64|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-8.64|-18.41|<0.0001
72365780|NCT01746901|144242402|SUPERIORITY_OR_OTHER||LS Mean Difference|-23.7|||<|0.0001|TWO_SIDED|95.0|-28.62|-18.78|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-18.78|-28.62|<0.0001
72365781|NCT01746901|144242403|SUPERIORITY_OR_OTHER||LS Mean Difference|-9.73|||<|0.0001|TWO_SIDED|95.0|-11.9|-7.57|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-7.57|-11.90|<0.0001
72365782|NCT01746901|144242403|SUPERIORITY_OR_OTHER||LS Mean Difference|5.16|||<|0.0001|TWO_SIDED|95.0|2.99|7.32|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||7.32|2.99|<0.0001
72365783|NCT01746901|144242403|SUPERIORITY_OR_OTHER||LS Mean Difference|0.03||||0.9766|TWO_SIDED|95.0|-2.13|2.2|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||2.20|-2.13|0.9766
72365784|NCT01746901|144242403|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.61|||<|0.0001|TWO_SIDED|95.0|-6.78|-2.44|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-2.44|-6.78|<0.0001
72431758|NCT00495469|144375423|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.5||||0.396|TWO_SIDED|95.0|-1.65|0.66||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change = Baseline + Treatment||||0.66|-1.65|0.396
72431759|NCT00495469|144375423|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.51||||0.013|TWO_SIDED|95.0|-2.7|-0.33||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change = Baseline + Treatment||||-0.33|-2.70|0.013
72431760|NCT00495469|144375423|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.44||||0.017|TWO_SIDED|95.0|-2.61|-0.26||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change = Baseline + Treatment||||-0.26|-2.61|0.017
72365785|NCT01746901|144242403|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.39||||0.7242|TWO_SIDED|95.0|-2.55|1.78|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||1.78|-2.55|0.7242
72365786|NCT01746901|144242403|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.45|||<|0.0001|TWO_SIDED|95.0|-6.62|-2.28|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-2.28|-6.62|<0.0001
72365787|NCT01746901|144242404|SUPERIORITY_OR_OTHER||LS Mean Difference|19.0|||<|0.0001|TWO_SIDED|95.0|14.6|23.5|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||23.5|14.6|<0.0001
72365788|NCT01746901|144242404|SUPERIORITY_OR_OTHER||LS Mean Difference|0.6||||0.8048|TWO_SIDED|95.0|-3.9|5.0|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||5.0|-3.9|0.8048
72365789|NCT01746901|144242404|SUPERIORITY_OR_OTHER||LS Mean Difference|8.6||||0.0002|TWO_SIDED|95.0|4.2|13.1|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||13.1|4.2|0.0002
72365790|NCT01746901|144242404|SUPERIORITY_OR_OTHER||LS Mean Difference|11.0|||<|0.0001|TWO_SIDED|95.0|6.5|15.4|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||15.4|6.5|<0.0001
72365791|NCT01746901|144242404|SUPERIORITY_OR_OTHER||LS Mean Difference|7.1||||0.0019|TWO_SIDED|95.0|2.7|11.6|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||11.6|2.7|0.0019
72365792|NCT01746901|144242404|SUPERIORITY_OR_OTHER||LS Mean Difference|7.6||||0.001|TWO_SIDED|95.0|3.2|12.1|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||12.1|3.2|0.0010
72365793|NCT01746901|144242404|SUPERIORITY_OR_OTHER||LS Mean Difference|127.4|||<|0.0001|TWO_SIDED|95.0|93.6|161.2|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||161.2|93.6|<0.0001
72365794|NCT01746901|144242404|SUPERIORITY_OR_OTHER||LS Mean Difference|4.7||||0.7837|TWO_SIDED|95.0|-29.1|38.5|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||38.5|-29.1|0.7837
72365795|NCT01746901|144242404|SUPERIORITY_OR_OTHER||LS Mean Difference|65.8||||0.0002|TWO_SIDED|95.0|32.0|99.6|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||99.6|32.0|0.0002
72431761|NCT00495469|144375423|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.45||||0.015|TWO_SIDED|95.0|-2.61|-0.28||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change = Baseline + Treatment||||-0.28|-2.61|0.015
72365796|NCT01746901|144242404|SUPERIORITY_OR_OTHER||LS Mean Difference|66.3||||0.0002|TWO_SIDED|95.0|32.5|100.1|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||100.1|32.5|0.0002
72365797|NCT01746901|144242404|SUPERIORITY_OR_OTHER||LS Mean Difference|60.3||||0.0006|TWO_SIDED|95.0|26.5|94.1|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||94.1|26.5|0.0006
72365798|NCT01746901|144242404|SUPERIORITY_OR_OTHER||LS Mean Difference|31.9||||0.064|TWO_SIDED|95.0|-1.9|65.7|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||65.7|-1.9|0.0640
72365799|NCT01746901|144242404|SUPERIORITY_OR_OTHER||LS Mean Difference|142.6|||<|0.0001|TWO_SIDED|95.0|94.5|190.7|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||190.7|94.5|<0.0001
72365800|NCT01746901|144242404|SUPERIORITY_OR_OTHER||LS Mean Difference|15.8||||0.5169|TWO_SIDED|95.0|-32.3|63.9|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||63.9|-32.3|0.5169
72365801|NCT01746901|144242404|SUPERIORITY_OR_OTHER||LS Mean Difference|81.3||||0.0011|TWO_SIDED|95.0|33.2|129.3|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||129.3|33.2|0.0011
72431762|NCT00495469|144375423|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.09||||0.069|TWO_SIDED|95.0|-2.26|0.08||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change = Baseline + Treatment||||0.08|-2.26|0.069
72365802|NCT01746901|144242404|SUPERIORITY_OR_OTHER||LS Mean Difference|77.1||||0.0018|TWO_SIDED|95.0|29.1|125.2|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||125.2|29.1|0.0018
72365803|NCT01746901|144242404|SUPERIORITY_OR_OTHER||LS Mean Difference|63.6||||0.0098|TWO_SIDED|95.0|15.6|111.7|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||111.7|15.6|0.0098
72365804|NCT01746901|144242404|SUPERIORITY_OR_OTHER||LS Mean Difference|39.4||||0.1078|TWO_SIDED|95.0|-8.7|87.4|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||87.4|-8.7|0.1078
72365805|NCT01746901|144242404|SUPERIORITY_OR_OTHER||LS Mean Difference|196.0|||<|0.0001|TWO_SIDED|95.0|116.9|275.1|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||275.1|116.9|<0.0001
72365806|NCT01746901|144242404|SUPERIORITY_OR_OTHER||LS Mean Difference|1.4||||0.9726|TWO_SIDED|95.0|-77.7|80.5|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||80.5|-77.7|0.9726
72365807|NCT01746901|144242404|SUPERIORITY_OR_OTHER||LS Mean Difference|114.1||||0.005|TWO_SIDED|95.0|35.0|193.2|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||193.2|35.0|0.0050
72365808|NCT01746901|144242404|SUPERIORITY_OR_OTHER||LS Mean Difference|83.3||||0.0392|TWO_SIDED|95.0|4.2|162.4|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||162.4|4.2|0.0392
72365809|NCT01746901|144242404|SUPERIORITY_OR_OTHER||LS Mean Difference|68.7||||0.0883|TWO_SIDED|95.0|-10.4|147.8|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||147.8|-10.4|0.0883
72365810|NCT01746901|144242404|SUPERIORITY_OR_OTHER||LS Mean Difference|64.4||||0.11|TWO_SIDED|95.0|-14.7|143.5|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||143.5|-14.7|0.1100
72365811|NCT01746901|144242404|SUPERIORITY_OR_OTHER||LS Mean Difference|242.9|||<|0.0001|TWO_SIDED|95.0|138.6|347.2|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||347.2|138.6|<0.0001
72365812|NCT01746901|144242404|SUPERIORITY_OR_OTHER||LS Mean Difference|-21.0||||0.6906|TWO_SIDED|95.0|-125.3|83.2|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||83.2|-125.3|0.6906
72365813|NCT01746901|144242404|SUPERIORITY_OR_OTHER||LS Mean Difference|118.7||||0.0259|TWO_SIDED|95.0|14.5|223.0|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||223.0|14.5|0.0259
72365814|NCT01746901|144242404|SUPERIORITY_OR_OTHER||LS Mean Difference|103.2||||0.0525|TWO_SIDED|95.0|-1.1|207.5|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||207.5|-1.1|0.0525
72365815|NCT01746901|144242404|SUPERIORITY_OR_OTHER||LS Mean Difference|60.2||||0.2558|TWO_SIDED|95.0|-44.1|164.4|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||164.4|-44.1|0.2558
72365816|NCT01746901|144242404|SUPERIORITY_OR_OTHER||LS Mean Difference|88.6||||0.0952|TWO_SIDED|95.0|-15.7|192.9|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||192.9|-15.7|0.0952
72431763|NCT00495469|144375423|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.03||||0.086|TWO_SIDED|95.0|-0.15|2.2||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change = Baseline + Treatment||||2.20|-0.15|0.086
72431764|NCT01323660|144375438|SUPERIORITY_OR_OTHER||Least squares mean difference|25.0||||0.456|TWO_SIDED|95.0|-41.0|91.0||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least square mean change difference=UMEC 62.5 µg minus Placebo.|||91.0|-41.0|0.456
72365817|NCT01746901|144242405|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.8||||0.0298|TWO_SIDED|95.0|-3.3|-0.2|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-0.2|-3.3|0.0298
72365818|NCT01746901|144242405|SUPERIORITY_OR_OTHER||LS Mean Difference|2.7||||0.0008|TWO_SIDED|95.0|1.1|4.3|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||4.3|1.1|0.0008
72365819|NCT01746901|144242405|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4||||0.645|TWO_SIDED|95.0|-2.0|1.2|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||1.2|-2.0|0.6450
72365820|NCT01746901|144242405|SUPERIORITY_OR_OTHER||LS Mean Difference|1.3||||0.0962|TWO_SIDED|95.0|-0.2|2.9|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||2.9|-0.2|0.0962
72365821|NCT01746901|144242405|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.0||||0.193|TWO_SIDED|95.0|-2.6|0.5|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||0.5|-2.6|0.1930
72365822|NCT01746901|144242405|SUPERIORITY_OR_OTHER||LS Mean Difference|1.7||||0.031|TWO_SIDED|95.0|0.2|3.3|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||3.3|0.2|0.0310
72431765|NCT01323660|144375438|SUPERIORITY_OR_OTHER||Least squares mean difference|74.7||||0.033|TWO_SIDED|95.0|6.0|143.4||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least square mean change difference=UMEC 125 µg minus Placebo.|||143.4|6.0|0.033
72431766|NCT01323660|144375438|SUPERIORITY_OR_OTHER||Least squares mean difference|30.6||||0.295|TWO_SIDED|95.0|-26.8|88.0||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least square mean change difference=VI 25 µg minus Placebo.|||88.0|-26.8|0.295
72431767|NCT01323660|144375438|SUPERIORITY_OR_OTHER||Least squares mean difference|44.4||||0.188|TWO_SIDED|95.0|-21.8|110.6||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least square mean change difference=UMEC/VI 62.5/25 µg minus UMEC 62.5 µg.|||110.6|-21.8|0.188
72365823|NCT01746901|144242406|SUPERIORITY_OR_OTHER||LS Mean Difference|41.5|||<|0.0001|TWO_SIDED|95.0|33.9|49.0|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||49.0|33.9|<0.0001
72365824|NCT01746901|144242406|SUPERIORITY_OR_OTHER||LS Mean Difference|3.4||||0.3763|TWO_SIDED|95.0|-4.2|10.9|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||10.9|-4.2|0.3763
72365825|NCT01746901|144242406|SUPERIORITY_OR_OTHER||LS Mean Difference|18.3|||<|0.0001|TWO_SIDED|95.0|10.7|25.8|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||25.8|10.7|<0.0001
72365826|NCT01746901|144242406|SUPERIORITY_OR_OTHER||LS Mean Difference|26.6|||<|0.0001|TWO_SIDED|95.0|19.1|34.1|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||34.1|19.1|<0.0001
72365827|NCT01746901|144242406|SUPERIORITY_OR_OTHER||LS Mean Difference|20.7|||<|0.0001|TWO_SIDED|95.0|13.1|28.2|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||28.2|13.1|<0.0001
72365828|NCT01746901|144242406|SUPERIORITY_OR_OTHER||LS Mean Difference|19.3|||<|0.0001|TWO_SIDED|95.0|11.8|26.8|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||26.8|11.8|<0.0001
72365829|NCT01746901|144242406|SUPERIORITY_OR_OTHER||LS Mean Difference|284.3|||<|0.0001|TWO_SIDED|95.0|232.9|335.8|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||335.8|232.9|<0.0001
72365830|NCT01746901|144242406|SUPERIORITY_OR_OTHER||LS Mean Difference|31.2||||0.2336|TWO_SIDED|95.0|-20.4|82.8|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||82.8|-20.4|0.2336
72365831|NCT01746901|144242406|SUPERIORITY_OR_OTHER||LS Mean Difference|167.3|||<|0.0001|TWO_SIDED|95.0|115.7|218.9|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||218.9|115.7|<0.0001
72365832|NCT01746901|144242406|SUPERIORITY_OR_OTHER||LS Mean Difference|148.3|||<|0.0001|TWO_SIDED|95.0|96.8|199.7|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||199.7|96.8|<0.0001
72365833|NCT01746901|144242406|SUPERIORITY_OR_OTHER||LS Mean Difference|135.6|||<|0.0001|TWO_SIDED|95.0|84.0|187.2|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||187.2|84.0|<0.0001
72365834|NCT01746901|144242406|SUPERIORITY_OR_OTHER||LS Mean Difference|113.6|||<|0.0001|TWO_SIDED|95.0|62.1|165.0|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||165.0|62.1|<0.0001
72365835|NCT01746901|144242406|SUPERIORITY_OR_OTHER||LS Mean Difference|278.3|||<|0.0001|TWO_SIDED|95.0|213.2|343.3|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||343.3|213.2|<0.0001
72365836|NCT01746901|144242406|SUPERIORITY_OR_OTHER||LS Mean Difference|71.3||||0.0322|TWO_SIDED|95.0|6.1|136.5|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||136.5|6.1|0.0322
72365837|NCT01746901|144242406|SUPERIORITY_OR_OTHER||LS Mean Difference|195.4|||<|0.0001|TWO_SIDED|95.0|130.2|260.5|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||260.5|130.2|<0.0001
72365838|NCT01746901|144242406|SUPERIORITY_OR_OTHER||LS Mean Difference|154.3|||<|0.0001|TWO_SIDED|95.0|89.2|219.3|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||219.3|89.2|<0.0001
72365839|NCT01746901|144242406|SUPERIORITY_OR_OTHER||LS Mean Difference|143.2|||<|0.0001|TWO_SIDED|95.0|78.0|208.4|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||208.4|78.0|<0.0001
72365840|NCT01746901|144242406|SUPERIORITY_OR_OTHER||LS Mean Difference|126.7||||0.0002|TWO_SIDED|95.0|61.7|191.8|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||191.8|61.7|0.0002
72365841|NCT01746901|144242406|SUPERIORITY_OR_OTHER||LS Mean Difference|202.4|||<|0.0001|TWO_SIDED|95.0|118.4|286.4|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||286.4|118.4|<0.0001
72365842|NCT01746901|144242406|SUPERIORITY_OR_OTHER||LS Mean Difference|137.6||||0.0015|TWO_SIDED|95.0|53.3|221.8|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||221.8|53.3|0.0015
72365843|NCT01746901|144242406|SUPERIORITY_OR_OTHER||LS Mean Difference|192.9|||<|0.0001|TWO_SIDED|95.0|108.7|277.2|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||277.2|108.7|<0.0001
72365844|NCT01746901|144242406|SUPERIORITY_OR_OTHER||LS Mean Difference|147.0||||0.0007|TWO_SIDED|95.0|63.0|231.1|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||231.1|63.0|0.0007
72365845|NCT01746901|144242406|SUPERIORITY_OR_OTHER||LS Mean Difference|148.1||||0.0007|TWO_SIDED|95.0|63.9|232.4|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||232.4|63.9|0.0007
72365846|NCT01746901|144242406|SUPERIORITY_OR_OTHER||LS Mean Difference|109.6||||0.011|TWO_SIDED|95.0|25.5|193.6|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||193.6|25.5|0.0110
72365847|NCT01746901|144242406|SUPERIORITY_OR_OTHER||LS Mean Difference|196.0|||<|0.0001|TWO_SIDED|95.0|107.4|284.6|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||284.6|107.4|<0.0001
72365848|NCT01746901|144242406|SUPERIORITY_OR_OTHER||LS Mean Difference|133.9||||0.0034|TWO_SIDED|95.0|45.0|222.8|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||222.8|45.0|0.0034
72365849|NCT01746901|144242406|SUPERIORITY_OR_OTHER||LS Mean Difference|190.9|||<|0.0001|TWO_SIDED|95.0|102.1|279.8|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||279.8|102.1|<0.0001
72365850|NCT01746901|144242406|SUPERIORITY_OR_OTHER||LS Mean Difference|138.9||||0.0023|TWO_SIDED|95.0|50.3|227.6|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||227.6|50.3|0.0023
72365851|NCT01746901|144242406|SUPERIORITY_OR_OTHER||LS Mean Difference|147.8||||0.0013|TWO_SIDED|95.0|59.0|236.7|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||236.7|59.0|0.0013
72365852|NCT01746901|144242406|SUPERIORITY_OR_OTHER||LS Mean Difference|100.0||||0.0273|TWO_SIDED|95.0|11.3|188.6|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||188.6|11.3|0.0273
72365853|NCT01746901|144242407|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.4|||<|0.0001|TWO_SIDED|95.0|-5.0|-1.8|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-1.8|-5.0|<0.0001
72431768|NCT01323660|144375438|SUPERIORITY_OR_OTHER||Least squares mean difference|38.8||||0.187|TWO_SIDED|95.0|-18.9|96.5||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least square mean change difference=UMEC/VI 62.5/25 µg minus VI 25 µg.|||96.5|-18.9|0.187
72365854|NCT01746901|144242407|SUPERIORITY_OR_OTHER||LS Mean Difference|2.9||||0.0004|TWO_SIDED|95.0|1.3|4.4|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||4.4|1.3|0.0004
72365855|NCT01746901|144242407|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2||||0.8478|TWO_SIDED|95.0|-1.7|1.4|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||1.4|-1.7|0.8478
72365856|NCT01746901|144242407|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4||||0.6192|TWO_SIDED|95.0|-1.9|1.2|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||1.2|-1.9|0.6192
72365857|NCT01746901|144242407|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1||||0.8857|TWO_SIDED|95.0|-1.7|1.4|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||1.4|-1.7|0.8857
72365858|NCT01746901|144242407|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.5||||0.5092|TWO_SIDED|95.0|-2.1|1.0|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||1.0|-2.1|0.5092
72365859|NCT02683577|144242420|SUPERIORITY_OR_OTHER||Geometric least square (LS) mean ratio|1.695|||||TWO_SIDED|90.0|0.904|3.176|||||A repeated-measures analysis of variance (ANOVA) was performed using a linear mixed effects model, with hepatic function group as a fixed term. Geometric LS mean ratios were derived for each HI group (Test) versus healthy control group (Reference).|Comparison of mild HI group (Test) versus healthy control group (Reference) for Cmax values for telotristat ethyl.||3.176|0.904|
72365860|NCT02683577|144242420|SUPERIORITY_OR_OTHER||Geometric LS mean ratio|2.462|||||TWO_SIDED|90.0|1.579|3.837|||||A repeated-measures ANOVA was performed using a linear mixed effects model, with hepatic function group as a fixed term. Geometric LS mean ratios were derived for each HI group (Test) versus healthy control group (Reference).|Comparison of moderate HI group (Test) versus healthy control group (Reference) for Cmax values for telotristat ethyl.||3.837|1.579|
72365861|NCT02683577|144242421|SUPERIORITY_OR_OTHER||Median difference|0.0|||=|1|TWO_SIDED|90.0|0.0|0.0|||Wilcoxon (Mann-Whitney)|||The Tmax was analysed using a non-parametric analysis (Walsh averages and appropriate quantile of the Wilcoxon signed rank test statistic). The median difference between the mild HI group (Test) versus healthy control group (Reference) and the corresponding 90% CIs were calculated by Hodges-Lehmann estimation.||0.000|0.000|=1.0000
72365862|NCT02683577|144242421|SUPERIORITY_OR_OTHER||Median difference|0.0|||=|1|TWO_SIDED|90.0|0.0|0.0|||Wilcoxon (Mann-Whitney)|||The Tmax was analysed using a non-parametric analysis (Walsh averages and appropriate quantile of the Wilcoxon signed rank test statistic). The median difference between the moderate HI group (Test) versus healthy control group (Reference) and the corresponding 90% CIs were calculated by Hodges-Lehmann estimation.||0.000|0.000|=1.0000
72365863|NCT02683577|144242422|SUPERIORITY_OR_OTHER||Geometric LS mean ratio|2.294|||||TWO_SIDED|90.0|1.144|4.598|||||A repeated-measures ANOVA was performed using a linear mixed effects model, with hepatic function group as a fixed term. Geometric LS mean ratios were derived for each HI group (Test) versus healthy control group (Reference).|Comparison of mild HI group (Test) versus healthy control group (Reference) for AUC(0-tlast) values for telotristat ethyl.||4.598|1.144|
72365864|NCT02683577|144242422|SUPERIORITY_OR_OTHER||Geometric LS mean ratio|3.168|||||TWO_SIDED|90.0|1.715|5.852|||||A repeated-measures ANOVA was performed using a linear mixed effects model, with hepatic function group as a fixed term. Geometric LS mean ratios were derived for each HI group (Test) versus healthy control group (Reference).|Comparison of moderate HI group (Test) versus healthy control group (Reference) on AUC(0-tlast) values for telotristat ethyl.||5.852|1.715|
72365865|NCT02683577|144242424|SUPERIORITY_OR_OTHER||Geometric LS mean ratio|1.72|||||TWO_SIDED|90.0|1.11|2.65|||||A repeated-measures ANOVA was performed using a linear mixed effects model, with hepatic function group as a fixed term. Geometric LS mean ratios were derived for each HI group (Test) versus healthy control group (Reference).|Comparison of mild HI group (Test) versus healthy control group (Reference) for Cmax values for LP-778902.||2.65|1.11|
72365866|NCT02683577|144242424|SUPERIORITY_OR_OTHER||Geometric LS mean ratio|2.0|||||TWO_SIDED|90.0|1.51|2.66|||||A repeated-measures ANOVA was performed using a linear mixed effects model, with hepatic function group as a fixed term. Geometric LS mean ratios were derived for each HI group (Test) versus healthy control group (Reference).|Comparison of moderate HI group (Test) versus healthy control group (Reference) on Cmax values for LP-778902.||2.66|1.51|
72365867|NCT02683577|144242425|SUPERIORITY_OR_OTHER||Median difference|0.0|||=|0.316|TWO_SIDED|90.0|0.0|1.0|||Wilcoxon (Mann-Whitney)|||The Tmax was analysed using a non-parametric analysis (Walsh averages and appropriate quantile of the Wilcoxon signed rank test statistic). The median differences between the hepatic impaired group (Test) versus the healthy control group (Reference) and the corresponding 90% CIs were calculated by Hodges-Lehmann estimation.||1.000|0.000|=0.3160
72365868|NCT02683577|144242425|SUPERIORITY_OR_OTHER||Median difference|0.0|||=|0.4671|TWO_SIDED|90.0|0.0|1.0|||Wilcoxon (Mann-Whitney)|||The Tmax was analysed using a non-parametric analysis (Walsh averages and appropriate quantile of the Wilcoxon signed rank test statistic). The median differences between the hepatic impaired group (Test) versus the healthy control group (Reference) and the corresponding 90% CIs were calculated by Hodges-Lehmann estimation.||1.000|0.000|=0.4671
72365869|NCT02683577|144242426|SUPERIORITY_OR_OTHER||Geometric LS mean ratio|2.39|||||TWO_SIDED|90.0|1.45|3.94|||||A repeated-measures ANOVA was performed using a linear mixed effects model, with hepatic function group as a fixed term. Geometric LS mean ratios were derived for each HI group (Test) versus healthy control group (Reference).|Comparison of mild HI group (Test) versus healthy control group (Reference) on AUC(0-tlast) values for LP-778902.||3.94|1.45|
72365870|NCT02683577|144242426|SUPERIORITY_OR_OTHER||Geometric LS mean ratio|3.52|||||TWO_SIDED|90.0|2.45|5.03|||||A repeated-measures ANOVA was performed using a linear mixed effects model, with hepatic function group as a fixed term. Geometric LS mean ratios were derived for each HI group (Test) versus healthy control group (Reference).|Comparison of moderate HI group (Test) versus healthy control group (Reference) on AUC(0-tlast) values for LP-778902.||5.03|2.45|
72365871|NCT02683577|144242427|SUPERIORITY_OR_OTHER||Geometric LS mean ratio|2.26|||||TWO_SIDED|90.0|1.33|3.82|||||A repeated-measures ANOVA was performed using a linear mixed effects model, with hepatic function group as a fixed term. Geometric LS mean ratios were derived for each HI group (Test) versus healthy control group (Reference).|Comparison of mild HI group (Test) versus healthy control group (Reference) on ln transformed AUC(0-inf) values for LP-778902.||3.82|1.33|
72365872|NCT02683577|144242427|SUPERIORITY_OR_OTHER||Geometric LS mean ratio|3.32|||||TWO_SIDED|90.0|2.3|4.8|||||A repeated-measures ANOVA was performed using a linear mixed effects model, with hepatic function group as a fixed term. Geometric LS mean ratios were derived for each HI group (Test) versus healthy control group (Reference).|Comparison of moderate HI group (Test) versus healthy control group (Reference) on AUC(0-inf) values for LP-778902.||4.80|2.30|
72365873|NCT05571605|144242432|OTHER|||||||0.05|||||||ANOVA|||||||0.05
72365874|NCT01409707|144242439|SUPERIORITY_OR_OTHER||||||=|0.068||95.0||||The a priori threshold for statistical significance was set at p = .05.|Mixed Models Analysis|||Multilevel mixed modeling was employed. The null hypothesis was that there'd be no differences between groups at posttreatment on posttraumatic stress disorder measures or alcohol use measures.||||=.068
72365875|NCT01409707|144242440|SUPERIORITY_OR_OTHER||||||=|0.39||95.0||||The a priori threshold for statistical significance was set at p=.05.|Mixed Models Analysis|||Multilevel mixed modeling was employed. The null hypothesis was that there would be no differences in alcohol use at posttreatment.||||= 0.39
72365876|NCT04322526|144242445|OTHER|||||||0.01|||||||t-test, 2 sided|||Changes in BOLD signal in the rACC during the processing of contextual cues (pleasant \> unpleasant).||||0.01
72365877|NCT04322526|144242446|OTHER|Mechanistic hypothesis: naltrexone will block contextual processing.||||||0.0002|||||||t-test, 2 sided|||Changes in BOLD fMRI signal from the Placebo vs. the Naltrexone session.||||0.0002
72365878|NCT00935584|144242533|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Mixed Models Analysis|||The null hypothesis states that there is no significant change in outcome from pre-intervention clinical visit (baseline) to post-intervention clinic visit.||||>0.05
72365879|NCT00935584|144242533|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Wilcoxon signed rank test|||The null hypothesis states that there is no significant change in outcome from pre-intervention clinical visit (baseline) to post-intervention clinic visit.||||>0.05
72365880|NCT00935584|144242534|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Mixed Models Analysis|||The null hypothesis is that there is no significant change in outcome from pre to post visit.||||>0.05
72365881|NCT00935584|144242534|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Wicoxon signed rank test|||The null hypothesis is that there is no significant change in outcome from pre to post visit.||||>0.05
72365882|NCT00935584|144242535|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Mixed Models Analysis|||The null hypothesis is that there is no significant change in patient engagement from pre to post visit.||||>0.05
72365883|NCT00935584|144242535|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Wilcoxon signed rank test|||The null hypothesis is that there is no significant change in patient engagement from pre to post visit.||||>0.05
72365884|NCT00935584|144242536|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Mixed Models Analysis|||The null hypothesis states that there is no significant change in outcome from pre-intervention clinical visit (baseline) to post-intervention clinic visit.||||<0.05
72365885|NCT00935584|144242536|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Wilcoxon signed rank test|||The null hypothesis states that there is no significant change in outcome from pre-intervention clinical visit (baseline) to post-intervention clinic visit.||||<0.05
72365886|NCT00935584|144242537|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Mixed Models Analysis|||The null hypothesis is that there is no significant change in outcome from pre to post visit.||||<0.05
72365887|NCT00935584|144242537|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Wilcoxon signed rank test|||The null hypothesis is that there is no significant change in outcome from pre to post visit.||||<0.05
72365888|NCT00935584|144242538|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Mixed Models Analysis|||The null hypothesis states that there is no significant change in outcome from pre-intervention clinical visit (baseline) to post-intervention clinic visit.||||<0.05
72365889|NCT00935584|144242538|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Wilcoxon signed rank test|||The null hypothesis states that there is no significant change in outcome from pre-intervention clinical visit (baseline) to post-intervention clinic visit.||||<0.05
72365890|NCT03863080|144242629|SUPERIORITY||Least square mean difference|-56.33|||<|0.0001|TWO_SIDED||||||ANCOVA||Treatment comparison between Placebo and RVT-1401 340 mg/week of Total IgG levels has been presented.|||||<0.0001
72365891|NCT03863080|144242629|SUPERIORITY||Least square mean difference|-74.49|||<|0.0001|TWO_SIDED||||||ANCOVA||Treatment comparison between Placebo and RVT-1401 680 mg/week of Total IgG levels has been presented.|||||<0.0001
72365892|NCT03863080|144242630|SUPERIORITY||Least square mean difference|-62.7|||<|0.001|TWO_SIDED||||||ANCOVA||Treatment comparison between Placebo and RVT-1401 340 mg/week of IgG 1 subclass has been presented.|||||<0.001
72365893|NCT03863080|144242630|SUPERIORITY||Least square mean difference|-73.0|||<|0.001|TWO_SIDED||||||ANCOVA||Treatment comparison between Placebo and RVT-1401 680 mg/week of IgG 1 subclass has been presented.|||||<0.001
72365894|NCT03863080|144242630|SUPERIORITY||Least square mean difference|-52.5|||<|0.001|TWO_SIDED||||||ANCOVA||Treatment comparison between Placebo and RVT-1401 340 mg/week of IgG 2 subclass has been presented.|||||<0.001
72365895|NCT03863080|144242630|SUPERIORITY||Least square mean difference|-61.4|||<|0.001|TWO_SIDED||||||ANCOVA||Treatment comparison between Placebo and RVT-1401 680 mg/week of IgG 2 subclass has been presented.|||||<0.001
72365896|NCT03863080|144242630|SUPERIORITY||Least square mean difference|-66.1|||<|0.001|TWO_SIDED||||||ANCOVA||Treatment comparison between Placebo and RVT-1401 340 mg/week of IgG 3 subclass has been presented.|||||<0.001
72365897|NCT03863080|144242630|SUPERIORITY||Least square mean difference|-80.8|||<|0.001|TWO_SIDED||||||ANCOVA||Treatment comparison between Placebo and RVT-1401 680 mg/week of IgG 3 subclass has been presented.|||||<0.001
72365898|NCT03863080|144242630|SUPERIORITY||Least square mean difference|-44.9|||<|0.001|TWO_SIDED||||||ANCOVA||Treatment comparison between Placebo and RVT-1401 340 mg/week of IgG 4 subclass has been presented.|||||<0.001
72365899|NCT03863080|144242630|SUPERIORITY||Least square mean difference|-61.6|||<|0.001|TWO_SIDED||||||ANCOVA||Treatment comparison between Placebo and RVT-1401 680 mg/week of IgG 4 subclass has been presented.|||||<0.001
72365900|NCT03863080|144242631|SUPERIORITY||Least square mean difference|-62.58||||0.0009|TWO_SIDED||||||ANCOVA||Treatment comparison between Placebo and RVT-1401 340 mg/week of Anti-AChR-IgG has been presented.|||||0.0009
72365901|NCT03863080|144242631|SUPERIORITY||Least square mean difference|-101.2|||<|0.0001|TWO_SIDED||||||ANCOVA||Treatment comparison between Placebo and RVT-1401 680 mg/week of Anti-AChR-IgG has been presented.|||||<0.0001
72365902|NCT01342211|144242647|SUPERIORITY_OR_OTHER||Least squares (LS) Mean Difference|-5.63|STANDARD_ERROR_OF_MEAN|9.759||0.5661|TWO_SIDED|95.0|-25.09|13.83|||ANCOVA|||Analysis was performed using analysis of covariance (ANCOVA) model with fixed effects for treatment, background statin, treatment by background statin interaction, and baseline.||13.83|-25.09|0.5661
72365903|NCT01342211|144242647|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.3|STANDARD_ERROR_OF_MEAN|9.422||0.808|TWO_SIDED|95.0|-21.08|16.49|||ANCOVA|||Analysis was performed using ANCOVA model with fixed effects for treatment, background statin, treatment by background statin interaction, and baseline.||16.49|-21.08|0.8080
72365904|NCT01342211|144242647|SUPERIORITY_OR_OTHER||LS Mean Difference|-37.72|STANDARD_ERROR_OF_MEAN|9.404||0.0001|TWO_SIDED|95.0|-56.47|-18.97|||ANCOVA|||Analysis was performed using ANCOVA model with fixed effects for treatment, background statin, treatment by background statin interaction, and baseline.||-18.97|-56.47|0.0001
72365905|NCT01342211|144242647|SUPERIORITY_OR_OTHER||LS Mean Difference|-49.11|STANDARD_ERROR_OF_MEAN|9.514|<|0.0001|TWO_SIDED|95.0|-68.08|-30.14|||ANCOVA|||Analysis was performed using ANCOVA model with fixed effects for treatment, background statin, treatment by background statin interaction, and baseline.||-30.14|-68.08|<0.0001
72365906|NCT01342211|144242648|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.172||||0.8998|TWO_SIDED|95.0|0.1|13.92|||Regression, Logistic|||Day 29, \<70 mg/dL: The standard logistic regression model was used to assess treatment effect.||13.92|0.10|0.8998
72365907|NCT01342211|144242648|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.063||||0.5273|TWO_SIDED|95.0|0.22|19.48|||Regression, Logistic|||Day 29, \<70 mg/dL: The standard logistic regression model was used to assess treatment effect.||19.48|0.22|0.5273
72365908|NCT01342211|144242648|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|53.924||||0.0004|TWO_SIDED|95.0|5.93|490.67|||Regression, Logistic|||Day 29, \<70 mg/dL: The standard logistic regression model was used to assess treatment effect.||490.67|5.93|0.0004
72365909|NCT01342211|144242648|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|280.366|||<|0.0001|TWO_SIDED|95.0|18.65|4214.35|||Regression, Logistic|||Day 29, \<70 mg/dL: The standard logistic regression model was used to assess treatment effect.||4214.35|18.65|<0.0001
72365910|NCT01342211|144242648|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.262||||0.086|TWO_SIDED|95.0|0.06|1.21|||Regression, Logistic|||Day 29, \<100 mg/dL: The standard logistic regression model was used to assess treatment effect.||1.21|0.06|0.0860
72365911|NCT01342211|144242648|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.579||||0.4308|TWO_SIDED|95.0|0.15|2.25|||Regression, Logistic|||Day 29, \<100 mg/dL: The standard logistic regression model was used to assess treatment effect.||2.25|0.15|0.4308
72365912|NCT01342211|144242648|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|8.272||||0.0127|TWO_SIDED|95.0|1.57|43.56|||Regression, Logistic|||Day 29, \<100 mg/dL: The standard logistic regression model was used to assess treatment effect.||43.56|1.57|0.0127
72365913|NCT01342211|144242648|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|13.528||||0.0096|TWO_SIDED|95.0|1.89|97.0|||Regression, Logistic|||Day 29, \<100 mg/dL: The standard logistic regression model was used to assess treatment effect.||97.00|1.89|0.0096
72365914|NCT01342211|144242648|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.131||||0.9519|TWO_SIDED|95.0|0.02|61.54|||Regression, Logistic|||Day 57, \<70 mg/dL: The standard logistic regression model was used to assess treatment effect.||61.54|0.02|0.9519
72365915|NCT01342211|144242648|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.069||||0.974|TWO_SIDED|95.0|0.02|58.0|||Regression, Logistic|||Day 57, \<70 mg/dL: The standard logistic regression model was used to assess treatment effect.||58.00|0.02|0.9740
72365916|NCT01342211|144242648|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|28.286||||0.0273|TWO_SIDED|95.0|1.46|549.78|||Regression, Logistic|||Day 57, \<70 mg/dL: The standard logistic regression model was used to assess treatment effect.||549.78|1.46|0.0273
72365917|NCT01342211|144242648|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|114.508||||0.0022|TWO_SIDED|95.0|5.5|2384.03|||Regression, Logistic|||Day 57, \<70 mg/dL: The standard logistic regression model was used to assess treatment effect.||2384.03|5.50|0.0022
72365918|NCT01342211|144242648|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.216||||0.0684|TWO_SIDED|95.0|0.04|1.12|||Regression, Logistic|||Day 57, \<100 mg/dL: The standard logistic regression model was used to assess treatment effect.||1.12|0.04|0.0684
72365919|NCT01342211|144242648|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.081||||0.9068|TWO_SIDED|95.0|0.29|3.99|||Regression, Logistic|||Day 57, \<100 mg/dL: The standard logistic regression model was used to assess treatment effect.||3.99|0.29|0.9068
72365920|NCT01342211|144242648|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.251||||0.2235|TWO_SIDED|95.0|0.61|8.31|||Regression, Logistic|||Day 57, \<100 mg/dL: The standard logistic regression model was used to assess treatment effect.||8.31|0.61|0.2235
72365921|NCT01342211|144242648|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|8.25||||0.012|TWO_SIDED|95.0|1.59|42.82|||Regression, Logistic|||Day 57, \<100 mg/dL: The standard logistic regression model was used to assess treatment effect.||42.82|1.59|0.0120
72365922|NCT01342211|144242648|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.359||||0.5449|TWO_SIDED|95.0|0.01|9.92|||Regression, Logistic|||Day 85, \<70 mg/dL: The standard logistic regression model was used to assess treatment effect.||9.92|0.01|0.5449
72365923|NCT01342211|144242648|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.914||||0.5585|TWO_SIDED|95.0|0.22|16.85|||Regression, Logistic|||Day 85, \<70 mg/dL: The standard logistic regression model was used to assess treatment effect.||16.85|0.22|0.5585
72365924|NCT01342211|144242648|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|21.059||||0.0022|TWO_SIDED|95.0|3.0|147.65|||Regression, Logistic|||Day 85, \<70 mg/dL: The standard logistic regression model was used to assess treatment effect.||147.65|3.00|0.0022
72365925|NCT01342211|144242648|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|22.851||||0.002|TWO_SIDED|95.0|3.15|165.99|||Regression, Logistic|||Day 85, \<70 mg/dL: The standard logistic regression model was used to assess treatment effect.||165.99|3.15|0.0020
72365926|NCT01342211|144242648|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.844||||0.375|TWO_SIDED|95.0|0.48|7.12|||Regression, Logistic|||Day 85, \<100 mg/dL: The standard logistic regression model was used to assess treatment effect.||7.12|0.48|0.3750
72365927|NCT01342211|144242648|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.078||||0.914|TWO_SIDED|95.0|0.28|4.23|||Regression, Logistic|||Day 85, \<100 mg/dL: The standard logistic regression model was used to assess treatment effect.||4.23|0.28|0.9140
72365928|NCT01342211|144242648|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|9.548||||0.0036|TWO_SIDED|95.0|2.09|43.57|||Regression, Logistic|||Day 85, \<100 mg/dL: The standard logistic regression model was used to assess treatment effect.||43.57|2.09|0.0036
72365929|NCT01342211|144242648|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.093||||0.0149|TWO_SIDED|95.0|1.42|26.1|||Regression, Logistic|||Day 85, \<100 mg/dL: The standard logistic regression model was used to assess treatment effect.||26.10|1.42|0.0149
72365930|NCT01342211|144242649|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.674||||0.5436|TWO_SIDED|95.0|0.32|8.83|||Regression, Logistic|||Day 29: The standard logistic regression model was used to assess treatment effect.||8.83|0.32|0.5436
72365931|NCT01342211|144242649|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.734||||0.742|TWO_SIDED|95.0|0.12|4.63|||Regression, Logistic|||Day 29: The standard logistic regression model was used to assess treatment effect.||4.63|0.12|0.7420
72365932|NCT01342211|144242649|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|28.151||||0.0002|TWO_SIDED|95.0|4.73|167.62|||Regression, Logistic|||Day 29: The standard logistic regression model was used to assess treatment effect.||167.62|4.73|0.0002
72365933|NCT01342211|144242649|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|71.214||||0.0001|TWO_SIDED|95.0|7.88|643.42|||Regression, Logistic|||Day 29: The standard logistic regression model was used to assess treatment effect.||643.42|7.88|0.0001
72365934|NCT01342211|144242649|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.203||||0.321|TWO_SIDED|95.0|0.01|4.74|||Regression, Logistic|||Day 57: The standard logistic regression model was used to assess treatment effect.||4.74|0.01|0.3210
72365935|NCT01342211|144242649|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.175||||0.3786|TWO_SIDED|95.0|0.39|12.27|||Regression, Logistic|||Day 57: The standard logistic regression model was used to assess treatment effect.||12.27|0.39|0.3786
72365936|NCT01342211|144242649|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|7.576||||0.0144|TWO_SIDED|95.0|1.5|38.38|||Regression, Logistic|||Day 57: The standard logistic regression model was used to assess treatment effect.||38.38|1.50|0.0144
72365937|NCT01342211|144242649|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|20.465||||0.0007|TWO_SIDED|95.0|3.59|116.6|||Regression, Logistic|||Day 57: The standard logistic regression model was used to assess treatment effect.||116.60|3.59|0.0007
72365938|NCT01342211|144242649|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.161||||0.8626|TWO_SIDED|95.0|0.21|6.3|||Regression, Logistic|||Day 85: The standard logistic regression model was used to assess treatment effect.||6.30|0.21|0.8626
72365939|NCT01342211|144242649|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.497||||0.6237|TWO_SIDED|95.0|0.3|7.51|||Regression, Logistic|||Day 85: The standard logistic regression model was used to assess treatment effect.||7.51|0.30|0.6237
72365940|NCT01342211|144242649|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|8.029||||0.0072|TWO_SIDED|95.0|1.76|36.65|||Regression, Logistic|||Day 85: The standard logistic regression model was used to assess treatment effect.||36.65|1.76|0.0072
72365941|NCT01342211|144242649|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|20.557||||0.0005|TWO_SIDED|95.0|3.73|113.2|||Regression, Logistic|||Day 85: The standard logistic regression model was used to assess treatment effect.||113.20|3.73|0.0005
72365942|NCT06482125|144242664|SUPERIORITY||Odds Ratio (OR)|40.955||||0.001|TWO_SIDED|95.0|14.098|118.972|||Chi-squared, Corrected|||||118.972|14.098|0.001
72365943|NCT06482125|144242665|EQUIVALENCE|The threshold for statistical significance is p \< 0.05||||||0.345|||||||Wilcoxon (Mann-Whitney)|||||||0.345
72365944|NCT06482125|144242666|EQUIVALENCE|The threshold for statistical significance is p \< 0.05||||||0.45|||||||Wilcoxon (Mann-Whitney)|||||||0.450
72365945|NCT06482125|144242667|EQUIVALENCE|Reject H0 = the means are equivalent|Median Difference (Net)|1.0||||0.356|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.356
72365946|NCT06482125|144242668|EQUIVALENCE|Reject H0 = the means are equivalent|Mean Difference (Final Values)|8.202||||0.07|TWO_SIDED|95.0|2.31|14.095|||t-test, 2 sided|||||14.095|2.310|0.07
72365947|NCT05786651|144242708|EQUIVALENCE|Comparison of conditions|||||<|0.05|||||||ANOVA|||||||<.05
72365948|NCT05786651|144242709|EQUIVALENCE|Comparisons of mean values of conditions|||||<|0.05|||||||ANOVA|||||||<.05
72365949|NCT04390763|144242715|OTHER||Hazard Ratio (HR)|0.7|||||ONE_SIDED|90.0||1.04|||Bayesian two-piece hazard model||Estimated posterior median of the HR after the risk changing timepoint and one-sided 90% credible interval are reported.|||1.04||
72365950|NCT04390763|144242715|OTHER||Hazard Ratio (HR)|1.41|||||ONE_SIDED|90.0||1.96|||Bayesian two-piece hazard model||Estimated posterior median of the HR after the risk changing timepoint and one-sided 90% credible interval are reported.|||1.96||
72365951|NCT04390763|144242716|OTHER||Hazard Ratio (HR)|1.02||||0.46|ONE_SIDED|90.0||1.37|||Regression, Cox|||||1.37||0.46
72365952|NCT04390763|144242716|OTHER||Hazard Ratio (HR)|1.08||||0.38|ONE_SIDED|90.0||1.44|||Regression, Cox|||||1.44||0.38
72365953|NCT03077412|144242779|SUPERIORITY||Risk Difference in Percentages|22.1|||||TWO_SIDED|90.0|-9.9|50.0|||||The 90% exact confidence interval (CI) was calculated based on binomial distribution (Clopper-Pearson method).|||50.0|-9.9|
72365954|NCT03077412|144242779|SUPERIORITY||Risk Difference in Percentages|4.2|||||TWO_SIDED|90.0|-26.5|34.3|||||The 90% exact CI was calculated based on binomial distribution (Clopper-Pearson method).|||34.3|-26.5|
72365955|NCT03077412|144242780|SUPERIORITY||Risk Difference in Percentages|30.4|||||TWO_SIDED|90.0|-1.3|57.3|||||The 90% exact CI was calculated based on binomial distribution (Clopper-Pearson method).|||57.3|-1.3|
72365956|NCT03077412|144242780|SUPERIORITY||Risk Difference in Percentages|8.3|||||TWO_SIDED|90.0|-22.5|38.1|||||The 90% exact CI was calculated based on binomial distribution (Clopper-Pearson method).|||38.1|-22.5|
72365957|NCT03077412|144242781|SUPERIORITY||Hazard Ratio (HR)|1.26|||||TWO_SIDED|90.0|0.64|2.49|||||Hazard ratio was derived from Cox Proportional-Hazards model.|||2.49|0.64|
72365958|NCT03077412|144242781|SUPERIORITY||Hazard Ratio (HR)|0.9|||||TWO_SIDED|90.0|0.47|1.75|||||Hazard ratio was derived from Cox Proportional-Hazards model.|||1.75|0.47|
72365959|NCT03077412|144242782|SUPERIORITY||Hazard Ratio (HR)|1.87|||||TWO_SIDED|90.0|0.87|4.01|||||Hazard ratio was derived from Cox Proportional-Hazards model.|||4.01|0.87|
72365960|NCT03077412|144242782|SUPERIORITY||Hazard Ratio (HR)|1.37|||||TWO_SIDED|90.0|0.65|2.92|||||Hazard ratio was derived from Cox Proportional-Hazards model.|||2.92|0.65|
72365961|NCT03077412|144242783|SUPERIORITY||Risk Difference in Percentages|-18.6|||||TWO_SIDED|90.0|-55.6|21.3|||||The 90% exact CI was calculated based on binomial distribution (Clopper-Pearson method).|||21.3|-55.6|
72365962|NCT03077412|144242783|SUPERIORITY||Risk Difference in Percentages|-13.2|||||TWO_SIDED|90.0|-51.0|24.1|||||The 90% exact CI was calculated based on binomial distribution (Clopper-Pearson method).|||24.1|-51.0|
72365963|NCT02266888|144242784|SUPERIORITY||Hazard Ratio (HR)|0.673||||0.514|TWO_SIDED|90.0|0.248|1.826|||Regression, Cox||Hazard ratio estimated for Rituximab vs. Placebo|||1.826|0.248|0.514
72365964|NCT02266888|144242788|SUPERIORITY||||||>|0.999|||||||Fisher Exact|||||||>0.999
72365965|NCT02266888|144242789|SUPERIORITY||||||>|0.999|||||||Fisher Exact|||||||>0.999
72365966|NCT02266888|144242790|SUPERIORITY|||||||0.188|||||||Fisher Exact|||||||0.188
72365967|NCT02266888|144242793|SUPERIORITY||Mean Difference (Net)|-1.62||||0.015|TWO_SIDED|90.0|-2.64|-0.6|||Paired t-Test|||This is not a comparison between treatment groups, but rather a comparison between timepoints.The Rituximab and Placebo groups were combined for purposes of testing the hypothesis that there would be no change in SD between pre-enrollment and 180 days post-enrollment into the TVI.||-0.60|-2.64|0.015
72365968|NCT02266888|144242795|SUPERIORITY|||||||0.502|||||||Cochran-Mantel-Haenszel|||||||0.502
72365969|NCT02266888|144242796|SUPERIORITY|||||||0.448|||||||Fisher Exact|||||||0.448
72365970|NCT03762993|144242820|OTHER|Changes in phonation threshold pressure were analyzed using a linear mixed effect model. Fixed factors included in the statistical model included time, group, and restoration strategy (controlled phonation or vocal rest). In addition, appropriate interactions were included and participant was added as a random factor in order to control for individual variation.|||||<|0.001||||||P-value is for the effect of time. A priori significance level set at .05|Mixed Models Analysis|||||||<0.001
72431769|NCT01323660|144375438|SUPERIORITY_OR_OTHER||Least squares mean difference|-8.9||||0.801|TWO_SIDED|95.0|-77.8|60.1||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least square mean change difference=UMEC/VI 125/25 µg minus UMEC 125 µg|||60.1|-77.8|0.801
72365971|NCT03762993|144242821|OTHER|Changes in lung volumes were analyzed using a linear mixed effect model. Fixed factors included in the statistical model included time, group, and restoration strategy (controlled phonation or vocal rest). In addition, appropriate interactions were included and participant was added as a random factor in order to control for individual variation.|||||<|0.01||||||P-value represents effect of group. A priori threshold for significance set at .05|Mixed Models Analysis|||||||<0.01
72365972|NCT01193244|144242822|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.707|||<|1e-05||95.0|0.626|0.799|||Log Rank|||Hazard ratio is based on a stratified Cox's proportional hazard regression model with stratification factors of region and radiographic disease progression at baseline with treatment as a factor in the model. A hazard ratio less than (\<) 1 indicated better prevention of death in the orteronel group compared to the placebo group. From log-rank test stratified by region and radiographic disease progression at Baseline.||0.799|0.626|<0.00001
72365973|NCT01193244|144242823|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.963||||0.59755||95.0|0.838|1.107|||Log Rank|||Hazard ratio is based on a stratified Cox's proportional hazard regression model with stratification factors of region and radiographic disease progression at baseline with treatment as a factor in the model. A hazard ratio \<1 indicated better prevention of death in the orteronel group compared to the placebo group. From log-rank test stratified by region and radiographic disease progression at baseline.||1.107|0.838|0.59755
72365974|NCT01193244|144242824|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.166|||<|0.001||95.0|1.724|2.721|||Regression, Logistic|||Logistic regression model with prognostic factors: region; radiographic disease progression at baseline; age; race; baseline Eastern Cooperative Oncology Group (ECOG) score; Gleason score at initial diagnosis; baseline PSA, natural log scale; presence of visceral disease; alkaline phosphatase; lactate dehydrogenase; and hemoglobin. Odds ratio greater than (\>)1 favored orteronel. P-values tested for odds ratio equal to 1.||2.721|1.724|<0.001
72365975|NCT01193244|144242825|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.712||||0.001||95.0|1.235|2.373|||Regression, Logistic|||Logistic regression model with prognostic factors: region; radiographic disease progression at baseline; age; race; baseline ECOG score; Gleason score at initial diagnosis; baseline PSA, natural log scale; presence of visceral disease; alkaline phosphatase; lactate dehydrogenase; and hemoglobin. Odds ratio \> 1 favored orteronel. P-values tested for odds ratio equal to 1.||2.373|1.235|0.001
72365976|NCT01193244|144242826|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.885||||0.33906||95.0|0.688|1.138|||Log Rank|||Hazard ratio is based on a stratified Cox's proportional hazard regression model with stratification factors of region and radiographic disease progression at baseline with treatment as a factor in the model. A hazard ratio less than (\<) 1 indicated better prevention of death in the orteronel group compared to the placebo group. From log-rank test stratified by region and radiographic disease progression at baseline.||1.138|0.688|0.33906
72365977|NCT03763877|144242857|SUPERIORITY||Mean Difference (Final Values)|0.12|STANDARD_ERROR_OF_MEAN|7.926||0.9883|TWO_SIDED|95.0|-15.42|15.66|||ANCOVA|ANCOVA model using a multiple imputation procedure based on the fully conditional specification method.|Mean difference (final values) is the difference in Least Squares (LS) Means estimated in the ANCOVA model.|||15.66|-15.42|0.9883
72365978|NCT03763877|144242857|SUPERIORITY||Mean Difference (Final Values)|-13.14|STANDARD_ERROR_OF_MEAN|7.609||0.0842|TWO_SIDED|95.0|-28.06|1.78|||ANCOVA|ANCOVA model using a multiple imputation procedure based on the fully conditional specification method.|Mean difference (final values) is the difference in LS Means estimated in the ANCOVA model.|||1.78|-28.06|0.0842
72365979|NCT03763877|144242857|SUPERIORITY||Mean Difference (Final Values)|-13.54|STANDARD_ERROR_OF_MEAN|7.636||0.0763|TWO_SIDED|95.0|-28.51|1.43|||ANCOVA|ANCOVA model using a multiple imputation procedure based on the fully conditional specification method.|Mean difference (final values) is the difference in LS Means estimated in the ANCOVA model.|||1.43|-28.51|0.0763
72365980|NCT03763877|144242858|SUPERIORITY||Mean Difference (Final Values)|-1.58|STANDARD_ERROR_OF_MEAN|7.265||0.8283|TWO_SIDED|95.0|-16.01|12.85|||ANCOVA||Mean difference (final values) is the difference in LS Means estimated in the ANCOVA model.|||12.85|-16.01|0.8283
72365981|NCT03763877|144242858|SUPERIORITY||Mean Difference (Final Values)|-13.25|STANDARD_ERROR_OF_MEAN|7.221||0.0698|TWO_SIDED|95.0|-27.6|1.1|||ANCOVA||Mean difference (final values) is the difference in LS Means estimated in the ANCOVA model.|||1.10|-27.60|0.0698
72365982|NCT03763877|144242858|SUPERIORITY||Mean Difference (Final Values)|-17.31|STANDARD_ERROR_OF_MEAN|7.207||0.0184|TWO_SIDED|95.0|-31.63|-2.99|||ANCOVA||Mean difference (final values) is the difference in LS Means estimated in the ANCOVA model.|||-2.99|-31.63|0.0184
72365983|NCT03763877|144242859|SUPERIORITY||Location Shift|-4.22||||0.5537|TWO_SIDED|95.0|-15.64|8.65|||Wilcoxon (Mann-Whitney)|||||8.65|-15.64|0.5537
72365984|NCT03763877|144242859|SUPERIORITY||Location Shift|-13.64||||0.1005|TWO_SIDED|95.0|-26.19|1.88|||Wilcoxon (Mann-Whitney)|||||1.88|-26.19|0.1005
72365985|NCT03763877|144242859|SUPERIORITY||Location Shift|-18.72||||0.0387|TWO_SIDED|95.0|-31.95|-1.58|||Wilcoxon (Mann-Whitney)|||||-1.58|-31.95|0.0387
72365986|NCT03763877|144242860|SUPERIORITY||Mean Difference (Final Values)|7.25|STANDARD_ERROR_OF_MEAN|0.5733||0.5733|TWO_SIDED|95.0|-18.0|32.51|||ANCOVA|ANCOVA model using a multiple imputation procedure based on the fully conditional specification method.|Mean difference (final values) is the difference in LS Means estimated in the ANCOVA model.|||32.51|-18.00|0.5733
72365987|NCT03763877|144242860|SUPERIORITY||Mean Difference (Final Values)|-10.61|STANDARD_ERROR_OF_MEAN|12.236||0.3861|TWO_SIDED|95.0|-34.6|13.38|||ANCOVA|ANCOVA model using a multiple imputation procedure based on the fully conditional specification method.|Mean difference (final values) is the difference in LS Means estimated in the ANCOVA model.|||13.38|-34.60|0.3861
72365988|NCT03763877|144242860|SUPERIORITY||Mean Difference (Final Values)|-21.13|STANDARD_ERROR_OF_MEAN|12.916||0.1019|TWO_SIDED|95.0|-46.46|4.19|||ANCOVA|ANCOVA model using a multiple imputation procedure based on the fully conditional specification method.|Mean difference (final values) is the difference in LS Means estimated in the ANCOVA model.|||4.19|-46.46|0.1019
72431770|NCT01323660|144375438|SUPERIORITY_OR_OTHER||Least squares mean difference|35.2||||0.233|TWO_SIDED|95.0|-22.7|93.1||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least square mean change difference=UMEC/VI 125/25 µg minus VI 25 µg.|||93.1|-22.7|0.233
72431771|NCT01323660|144375438|SUPERIORITY_OR_OTHER||Least squares mean difference|69.4||||0.003|TWO_SIDED|95.0|24.5|114.4|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least square mean change difference=UMEC/VI 62.5/25 µg minus Placebo.|||114.4|24.5|0.003
72365989|NCT03763877|144242861|SUPERIORITY||Mean Difference (Final Values)|-0.242|STANDARD_ERROR_OF_MEAN|1.3873||0.8617|TWO_SIDED|95.0|-2.961|2.478|||ANCOVA|ANCOVA model using a multiple imputation procedure based on the fully conditional specification method|Mean difference (final values) is the difference in LS Means estimated in the ANCOVA model.|||2.478|-2.961|0.8617
72365990|NCT03763877|144242861|SUPERIORITY||Mean Difference (Final Values)|-2.571|STANDARD_ERROR_OF_MEAN|1.3712||0.0609|TWO_SIDED|95.0|-5.26|0.117|||ANCOVA|ANCOVA model using a multiple imputation procedure based on the fully conditional specification method|||Mean difference (final values) is the difference in LS Means estimated in the ANCOVA model.|0.117|-5.260|0.0609
72365991|NCT03763877|144242861|SUPERIORITY||Mean Difference (Final Values)|-2.414|STANDARD_ERROR_OF_MEAN|1.3633||0.0766|TWO_SIDED|95.0|-5.087|0.258|||ANCOVA|ANCOVA using a multiple imputation procedure based on the fully conditional specification method|Mean difference (final values) is the difference in LS Means estimated in the ANCOVA model.|||0.258|-5.087|0.0766
72365992|NCT03763877|144242862|SUPERIORITY||Odds Ratio (OR)|1.744||||0.5592|TWO_SIDED|95.0|0.27|11.267|||Regression, Logistic|Logistic regression with multiple imputation||||11.267|0.270|0.5592
72365993|NCT03763877|144242862|SUPERIORITY||Odds Ratio (OR)|2.287||||0.3747|TWO_SIDED|95.0|0.368|14.208|||Regression, Logistic|Logistic regression with multiple imputation||||14.208|0.368|0.3747
72365994|NCT03763877|144242862|SUPERIORITY||Odds Ratio (OR)|5.669||||0.0501|TWO_SIDED|95.0|1.0|32.149|||Regression, Logistic|Logistic regression with multiple imputation||||32.149|1.000|0.0501
72365995|NCT03763877|144242863|SUPERIORITY||Mean Difference (Final Values)|-0.9|STANDARD_ERROR_OF_MEAN|3.71||0.8013|TWO_SIDED|95.0|-8.3|6.4|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||6.4|-8.3|0.8013
72365996|NCT03763877|144242863|SUPERIORITY||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|3.81||0.8694|TWO_SIDED|95.0|-8.2|7.0|||Mixed Models Analysis|Mixed Model Repeated Measures|||Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|7.0|-8.2|0.8694
72365997|NCT03763877|144242863|SUPERIORITY||Mean Difference (Final Values)|-7.3|STANDARD_ERROR_OF_MEAN|3.8||0.0581|TWO_SIDED|95.0|-14.9|0.3|||Mixed Models Analysis|Mixed Model Repeated Measures|||Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|0.3|-14.9|0.0581
72365998|NCT03763877|144242864|SUPERIORITY||Mean Difference (Final Values)|1.1|STANDARD_ERROR_OF_MEAN|2.44||0.6681|TWO_SIDED|95.0|-3.8|5.9|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||5.9|-3.8|0.6681
72365999|NCT03763877|144242864|SUPERIORITY||Mean Difference (Final Values)|0.6|STANDARD_ERROR_OF_MEAN|2.51||0.8224|TWO_SIDED|95.0|-4.4|5.5|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||5.5|-4.4|0.8224
72366000|NCT03763877|144242864|SUPERIORITY||Mean Difference (Final Values)|-4.3|STANDARD_ERROR_OF_MEAN|2.5||0.0924|TWO_SIDED|95.0|-9.2|0.7|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||0.7|-9.2|0.0924
72366001|NCT03763877|144242865|SUPERIORITY||Mean Difference (Final Values)|-0.17|STANDARD_ERROR_OF_MEAN|0.256||0.5148|TWO_SIDED|95.0|-0.68|0.34|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||0.34|-0.68|0.5148
72366002|NCT03763877|144242865|SUPERIORITY||Mean Difference (Final Values)|-0.53|STANDARD_ERROR_OF_MEAN|0.261||0.0434|TWO_SIDED|95.0|-1.05|-0.02|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||-0.02|-1.05|0.0434
72366003|NCT03763877|144242865|SUPERIORITY||Mean Difference (Final Values)|-0.52|STANDARD_ERROR_OF_MEAN|0.261||0.0494|TWO_SIDED|95.0|-1.04|0.0|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||0.00|-1.04|0.0494
72366004|NCT03763877|144242866|SUPERIORITY||Mean Difference (Final Values)|-0.13|STANDARD_ERROR_OF_MEAN|0.111||0.2449|TWO_SIDED|95.0|-0.35|0.09|||ANCOVA||Mean difference (final values) is the difference in LS Means estimated in the ANOVA model.|||0.09|-0.35|0.2449
72366005|NCT03763877|144242866|SUPERIORITY||Mean Difference (Final Values)|-0.23|STANDARD_ERROR_OF_MEAN|0.115||0.0502|TWO_SIDED|95.0|-0.46|0.0|||ANCOVA||Mean difference (final values) is the difference in LS Means estimated in the ANOVA model.|||0.00|-0.46|0.0502
72366006|NCT03763877|144242866|SUPERIORITY||Mean Difference (Final Values)|-0.29|STANDARD_ERROR_OF_MEAN|0.113||0.0123|TWO_SIDED|95.0|-0.51|-0.06|||ANCOVA||Mean difference (final values) is the difference in LS Means estimated in the ANOVA model.|||-0.06|-0.51|0.0123
72366007|NCT03763877|144242867|SUPERIORITY||Mean Difference (Final Values)|-0.251|STANDARD_ERROR_OF_MEAN|0.2172||0.251|TWO_SIDED|95.0|-0.682|0.18|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||0.180|-0.682|0.2510
72366008|NCT03763877|144242867|SUPERIORITY||Mean Difference (Final Values)|-0.049|STANDARD_ERROR_OF_MEAN|0.2202||0.8246|TWO_SIDED|95.0|-0.486|0.388|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||0.388|-0.486|0.8246
72366009|NCT03763877|144242867|SUPERIORITY||Mean Difference (Final Values)|-0.026|STANDARD_ERROR_OF_MEAN|0.2216||0.9067|TWO_SIDED|95.0|-0.466|0.414|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||0.414|-0.466|0.9067
72366010|NCT03763877|144242868|SUPERIORITY||Mean Difference (Final Values)|-0.018|STANDARD_ERROR_OF_MEAN|0.0468||0.6951|TWO_SIDED|95.0|-0.111|0.075|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||0.075|-0.111|0.6951
72366011|NCT03763877|144242868|SUPERIORITY||Mean Difference (Final Values)|-0.078|STANDARD_ERROR_OF_MEAN|0.0472||0.103|TWO_SIDED|95.0|-0.171|0.016|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||0.016|-0.171|0.1030
72366012|NCT03763877|144242868|SUPERIORITY||Mean Difference (Final Values)|0.008|STANDARD_ERROR_OF_MEAN|0.0471||0.8583|TWO_SIDED|95.0|-0.085|0.102|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||0.102|-0.085|0.8583
72366013|NCT03763877|144242869|SUPERIORITY||Mean Difference (Final Values)|-0.105|STANDARD_ERROR_OF_MEAN|0.1777||0.5576|TWO_SIDED|95.0|-0.457|0.248|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||0.248|-0.457|0.5576
72366014|NCT03763877|144242869|SUPERIORITY||Mean Difference (Final Values)|0.144|STANDARD_ERROR_OF_MEAN|0.1799||0.4261|TWO_SIDED|95.0|-0.213|0.501|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||0.501|-0.213|0.4261
72366015|NCT03763877|144242869|SUPERIORITY||Mean Difference (Final Values)|0.081|STANDARD_ERROR_OF_MEAN|0.1822||0.6571|TWO_SIDED|95.0|-0.281|0.443|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||0.443|-0.281|0.6571
72366016|NCT03763877|144242870|SUPERIORITY||Mean Difference (Final Values)|-0.161|STANDARD_ERROR_OF_MEAN|0.2851||0.5732|TWO_SIDED|95.0|-0.727|0.405|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||0.405|-0.727|0.5732
72366017|NCT03763877|144242870|SUPERIORITY||Mean Difference (Final Values)|-0.139|STANDARD_ERROR_OF_MEAN|0.2884||0.6312|TWO_SIDED|95.0|-0.712|0.434|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||0.434|-0.712|0.6312
72366018|NCT03763877|144242870|SUPERIORITY||Mean Difference (Final Values)|-0.201|STANDARD_ERROR_OF_MEAN|0.2865||0.4857|TWO_SIDED|95.0|-0.769|0.368|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||0.368|-0.769|0.4857
72366019|NCT03763877|144242871|SUPERIORITY||Mean Difference (Final Values)|0.04|STANDARD_ERROR_OF_MEAN|0.074||0.5737|TWO_SIDED|95.0|-0.11|0.19|||ANCOVA||Mean difference (final values) is the difference in LS Means estimated in the ANCOVA model.|||0.19|-0.11|0.5737
72366020|NCT03763877|144242871|SUPERIORITY||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.074||0.7563|TWO_SIDED|95.0|-0.12|0.17|||ANCOVA||Mean difference (final values) is the difference in LS Means estimated in the ANCOVA model.|||0.17|-0.12|0.7563
72366021|NCT03763877|144242871|SUPERIORITY||Mean Difference (Final Values)|-0.04|STANDARD_ERROR_OF_MEAN|0.075||0.5695|TWO_SIDED|95.0|-0.19|0.11|||ANCOVA||Mean difference (final values) is the difference in LS Means estimated in the ANCOVA model.|||0.11|-0.19|0.5695
72366022|NCT03763877|144242872|SUPERIORITY||Mean Difference (Final Values)|-0.04|STANDARD_ERROR_OF_MEAN|0.659||0.9552|TWO_SIDED|95.0|-1.34|1.27|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||1.27|-1.34|0.9552
72366023|NCT03763877|144242872|SUPERIORITY||Mean Difference (Final Values)|-0.76|STANDARD_ERROR_OF_MEAN|0.674||0.2633|TWO_SIDED|95.0|-2.1|0.58|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||0.58|-2.10|0.2633
72366024|NCT03763877|144242872|SUPERIORITY||Mean Difference (Final Values)|-0.88|STANDARD_ERROR_OF_MEAN|0.673||0.1962|TWO_SIDED|95.0|-2.21|0.46|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||0.46|-2.21|0.1962
72366025|NCT03763877|144242873|SUPERIORITY||Odds Ratio (OR)|1.353||||0.8245|TWO_SIDED|95.0|0.094|19.554|||Regression, Logistic|||||19.554|0.094|0.8245
72366026|NCT03763877|144242873|SUPERIORITY||Odds Ratio (OR)|2.791||||0.414|TWO_SIDED|95.0|0.238|32.752|||Regression, Logistic|||||32.752|0.238|0.4140
72366027|NCT03763877|144242873|SUPERIORITY||Odds Ratio (OR)|14.872||||0.0341|TWO_SIDED|95.0|1.226|180.452|||Regression, Logistic|||||180.452|1.226|0.0341
72366028|NCT03763877|144242874|SUPERIORITY||Mean Difference (Final Values)|-4.3|STANDARD_ERROR_OF_MEAN|5.84||0.4626|TWO_SIDED|95.0|-16.1|7.5|||Mixed Models Analysis||Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||7.5|-16.1|0.4626
72366029|NCT03763877|144242874|SUPERIORITY||Mean Difference (Final Values)|-6.0|STANDARD_ERROR_OF_MEAN|5.88||0.316|TWO_SIDED|95.0|-17.9|5.9|||Mixed Models Analysis||Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||5.9|-17.9|0.3160
72366030|NCT03763877|144242874|SUPERIORITY||Mean Difference (Final Values)|-14.9|STANDARD_ERROR_OF_MEAN|6.19||0.0204|TWO_SIDED|95.0|-27.4|-2.4|||Mixed Models Analysis||Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||-2.4|-27.4|0.0204
72366031|NCT03763877|144242875|SUPERIORITY||Mean Difference (Final Values)|-2.9|STANDARD_ERROR_OF_MEAN|3.91||0.4601|TWO_SIDED|95.0|-10.8|5.0|||Mixed Models Analysis||Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||5.0|-10.8|0.4601
72366032|NCT03763877|144242875|SUPERIORITY||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|3.95||0.9782|TWO_SIDED|95.0|-8.1|7.9|||Mixed Models Analysis||Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||7.9|-8.1|0.9782
72366033|NCT03763877|144242875|SUPERIORITY||Mean Difference (Final Values)|-9.9|STANDARD_ERROR_OF_MEAN|4.13||0.0205|TWO_SIDED|95.0|-18.3|-1.6|||Mixed Models Analysis||Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||-1.6|-18.3|0.0205
72366034|NCT03763877|144242876|SUPERIORITY||Mean Difference (Final Values)|-0.03|STANDARD_ERROR_OF_MEAN|0.538||0.9529|TWO_SIDED|95.0|-1.12|1.05|||Mixed Models Analysis||Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||1.05|-1.12|0.9529
72366035|NCT03763877|144242876|SUPERIORITY||Mean Difference (Final Values)|-0.82|STANDARD_ERROR_OF_MEAN|0.532||0.1285|TWO_SIDED|95.0|-1.9|0.25|||Mixed Models Analysis||Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||0.25|-1.90|0.1285
72366036|NCT03763877|144242876|SUPERIORITY||Mean Difference (Final Values)|-1.19|STANDARD_ERROR_OF_MEAN|0.565||0.0417|TWO_SIDED|95.0|-2.32|-0.05|||Mixed Models Analysis||Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||-0.05|-2.32|0.0417
72366037|NCT03763877|144242877|SUPERIORITY||Mean Difference (Final Values)|-0.23|STANDARD_ERROR_OF_MEAN|0.228||0.3141|TWO_SIDED|95.0|-0.69|0.23|||ANCOVA||Mean difference (final values) is the difference in LS Means estimated in the ANOVA model.|||0.23|-0.69|0.3141
72366038|NCT03763877|144242877|SUPERIORITY||Mean Difference (Final Values)|-0.43|STANDARD_ERROR_OF_MEAN|0.226||0.0656|TWO_SIDED|95.0|-0.88|0.03|||ANCOVA||Mean difference (final values) is the difference in LS Means estimated in the ANOVA model.|||0.03|-0.88|0.0656
72366039|NCT03763877|144242877|SUPERIORITY||Mean Difference (Final Values)|-0.64|STANDARD_ERROR_OF_MEAN|0.237||0.0101|TWO_SIDED|95.0|-1.12|-0.16|||ANCOVA||Mean difference (final values) is the difference in LS Means estimated in the ANOVA model.|||-0.16|-1.12|0.0101
72366040|NCT03537404|144242892|OTHER||Geometric Mean Ratio|0.02|||||TWO_SIDED|90.0|-0.103|0.142|||||Cmax parameters were logarithmically transformed|||0.142|-0.103|
72366041|NCT03537404|144242892|OTHER||Geometric Mean Ratio|-0.022|||||TWO_SIDED|90.0|-0.22|0.175|||||Cmax parameters were logarithmically transformed|||0.175|-0.220|
72366042|NCT03537404|144242893|OTHER||Geometric Mean Ratio|0.041|||||TWO_SIDED|90.0|-0.075|0.157|||||AUCtau parameters were logarithmically transformed.|||0.157|-0.075|
72366043|NCT03537404|144242893|OTHER||Geometric Mean Ratio|-0.069|||||TWO_SIDED|90.0|-0.201|0.064|||||AUCtau parameters were logarithmically transformed|||0.064|-0.201|
72366044|NCT03537404|144242894|OTHER||Geometric Mean Ratio|0.271|||||TWO_SIDED|90.0|0.159|0.383|||||Cmax parameters were logarithmically transformed|||0.383|0.159|
72366045|NCT03537404|144242895|OTHER||Geometric Mean Ratio|0.074|||||TWO_SIDED|90.0|0.016|0.132|||||AUCtau parameters were logarithmically transformed|||0.132|0.016|
72366046|NCT03537404|144242896|OTHER||Geometric Mean Ratio|-0.148|||||TWO_SIDED|90.0|-0.45|0.153|||||Cmax parameters were logarithmically transformed|||0.153|-0.450|
72366047|NCT03537404|144242897|OTHER||Geometric Mean Ratio|-0.093|||||TWO_SIDED|90.0|-0.354|0.168|||||AUCtau parameters were logarithmically transformed|||0.168|-0.354|
72366048|NCT00068692|144242903|SUPERIORITY|||||||0.35||||||One-sided p value was reported|Log Rank|stratified on ECOG performance status, clinical stage, timing of chemoradiotherapy, and regimen administration||||||0.35
72366049|NCT00068692|144242903|SUPERIORITY|||||||0.69||||||one-sided p value was reported|Log Rank|stratified on ECOG performance status, clinical stage, timing of chemoradiaotherapy, regimen administration||||||0.69
72366050|NCT00248040|144242924|SUPERIORITY|The model included fixed effect terms for center, time point, and treatment. Time point was specified as a repeated measurement.|Difference between means|-0.275||||0.9076|TWO_SIDED|95.0|-5.0|4.45|||Other|||This analysis refers to the 1-3 hours time point||4.45|-5.00|0.9076
72366051|NCT00248040|144242924|SUPERIORITY|The model included fixed effect terms for center, time point, and treatment. Time point was specified as a repeated measurement.|Difference between means|2.444||||0.3084|TWO_SIDED|95.0|-2.32|7.21|||Other|||This analysis refers to the 1-3 hours timepoint.||7.21|-2.32|0.3084
72366052|NCT00248040|144242924|OTHER||Difference between means|-2.719||||0.2565|TWO_SIDED|95.0|-7.47|2.03|||Other|||||2.03|-7.47|0.2565
72366053|NCT00248040|144242924|SUPERIORITY|The model included fixed effect terms for center, time point, and treatment. Time point was specified as a repeated measurement.|Difference between means|-0.063||||0.9855|TWO_SIDED|95.0|-6.91|6.79|||Other|||This analysis refers to the 10-12 hours time point.||6.79|-6.91|0.9855
72366054|NCT00248040|144242924|SUPERIORITY|The model included fixed effect terms for center, time point, and treatment. Time point was specified as a repeated measurement.|Difference between means|4.519||||0.1934|TWO_SIDED|95.0|-2.36|11.39|||Other|||This analysis refers to the 10-12 hours timepoint.||11.39|-2.36|0.1934
72366055|NCT00248040|144242924|OTHER|The model included fixed effect terms for center, time point, and treatment. Time point was specified as a repeated measurement.|Difference between means|-4.582||||0.1797|TWO_SIDED|95.0|-11.3|2.17|||Other|||This analysis refers to the 10-12 hours time point.||2.17|-11.3|0.1797
72366056|NCT01002339|144242947|SUPERIORITY_OR_OTHER_LEGACY|||||||0.02|||||||Chi-squared|||||||0.02
72366057|NCT01002339|144242948|SUPERIORITY_OR_OTHER_LEGACY|||||||0.06|||||||Chi-squared|||||||0.06
72366058|NCT01002339|144242949|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9|||||||Chi-squared|||||||0.9
72366059|NCT01002339|144242950|SUPERIORITY_OR_OTHER_LEGACY|||||||0.07|||||||Chi-squared|||||||0.07
72366060|NCT01002339|144242951|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2|||||||ANOVA|||||||0.2
72366061|NCT01002339|144242952|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4|||||||ANOVA|||||||0.4
72366062|NCT01002339|144242953|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8|||||||ANOVA|||||||0.8
72366063|NCT01002339|144242954|SUPERIORITY_OR_OTHER_LEGACY|||||||0.56|||||||ANOVA|||||||0.56
72366064|NCT01002339|144242955|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8|||||||Kruskal-Wallis|||||||0.8
72366065|NCT01002339|144242956|SUPERIORITY_OR_OTHER_LEGACY|||||||0.66|||||||ANOVA|||||||0.66
72366066|NCT01002339|144242957|SUPERIORITY_OR_OTHER_LEGACY|||||||0.37|||||||ANOVA|||||||0.37
72366067|NCT01002339|144242958|SUPERIORITY_OR_OTHER_LEGACY|||||||0.45|||||||ANOVA|||||||0.45
72366068|NCT01002339|144242959|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5|||||||ANOVA|||||||0.50
72366069|NCT01002339|144242960|SUPERIORITY_OR_OTHER_LEGACY|||||||0.17|||||||Chi-squared|||||||0.17
72366070|NCT01002339|144242961|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5|||||||ANOVA|||||||0.5
72366071|NCT01002339|144242962|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9|||||||Chi-squared|||||||0.9
72366072|NCT00790842|144242963|OTHER|Recommended Phase 2 dose for Group A|Dose in milligrams per day|25.0|||||TWO_SIDED||||||||Because no dose limiting toxicities were noted, the recommended phase 2 dose for patients with creatinine clearance of 30 to 60 mL/min is 25 mg/day|Recommended Phase 2 dose for Group A||||
72366073|NCT00790842|144242963|OTHER|Recommended phase 2 dose for patients in Group B|Dose in milligrams/day|25.0|||||TWO_SIDED||||||||Because no dose limiting toxicities were noted, the recommended phase 2 dose of lenalidomide is 25 mg/day for patients with creatinine clearance \< 30 mL/minute who are not on dialysis|Recommended phase 2 dose for patients in Group B||||
72366074|NCT00790842|144242963|OTHER|Recommended phase 2 dose for Group C|Lenalidomide dose in mg/day|25.0|||||TWO_SIDED||||||||Because no dose limiting toxicities were observed, the recommended phase 2 dose of lenalidomide is 25 mg/day for patients with creatinine clearance \< 30 mL/min who are receiving dialysis|Recommended phase 2 dose for Group C||||
72366075|NCT02158546|144242995|SUPERIORITY||Least square means difference|-0.3|STANDARD_ERROR_OF_MEAN|0.95||0.782|TWO_SIDED|95.0|-2.1|1.6|||Mixed Models Analysis|||||1.6|-2.1|0.782
72366076|NCT01208207|144243035|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The etoricoxib dose (90 mg) will be considered non-inferior to naproxen 1000 mg if the upper bound of the two-sided 95% confidence interval of the between-treatment difference in the least squares (LS) mean (etoricoxib minus naproxen 1000 mg) is no larger than 8 mm VAS (non-inferiority margin).|Difference in Least Squares Mean|-0.64|||||TWO_SIDED|95.0|-5.47|4.19|||ANCOVA|||||4.19|-5.47|
72366077|NCT01208207|144243036|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The etoricoxib dose (60 mg) will be considered non-inferior to naproxen 1000 mg if the upper bound of the two-sided 95% confidence interval of the between-treatment difference in the LS mean (etoricoxib minus naproxen 1000 mg) is no larger than 8 mm VAS (non-inferiority margin).|Difference in Least Squares Mean|1.59|||||TWO_SIDED|95.0|-2.19|5.37|||ANCOVA|||||5.37|-2.19|
72366078|NCT01208207|144243037|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Mean|-1.58||||0.396|TWO_SIDED|80.0|-3.96|0.81|||ANCOVA|||||0.81|-3.96|0.396
72366079|NCT01208207|144243038|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Mean|-2.7||||0.112||80.0|-4.88|-0.52|||ANCOVA|||||-0.52|-4.88|0.112
72366080|NCT02900378|144243053|OTHER||Differences of least square means|5.68|STANDARD_ERROR_OF_MEAN|4.89||0.2464|TWO_SIDED|95.0|-3.93|15.29||The comparison of treatment groups were out using an analysis of covariance (ANCOVA) model adjusting for treatment and baseline NYHA class (NYHA II vs. III/IV) and the 6MWT baseline value as covariates.|ANCOVA|||Change from BL at Week 12 (FAS)||15.29|-3.93|0.2464
72366081|NCT02900378|144243053|OTHER||Differences of least square means|8.98|STANDARD_ERROR_OF_MEAN|4.58||0.0503|TWO_SIDED|97.5|-1.31|19.27||The comparison of treatment groups were out using an analysis of covariance (ANCOVA) model adjusting for treatment and baseline NYHA class (NYHA II vs. III/IV) and the 6MWT baseline value as covariates.|ANCOVA|||Change from BL at Week 12 (FAS without AE/SAE)||19.27|-1.31|0.0503
72366082|NCT02900378|144243054|OTHER||Differences of least square means|-6.14|STANDARD_ERROR_OF_MEAN|8.61||0.4769|TWO_SIDED|97.5|-25.7|13.41||The comparison of treatment groups were carried out using an ANCOVA model adjusting for treatment, baseline NYHA class (NYHA II vs. III/IV) and the daily non-sedentary daytime activity baseline value as covariates.|ANCOVA|||Change from BL at Week 12 (FAS with MI)||13.41|-25.70|0.4769
72366083|NCT02900378|144243054|OTHER||Differences of least square means|-5.67|STANDARD_ERROR_OF_MEAN|6.01||0.3463|TWO_SIDED|95.0|-17.48|6.14||The comparison of treatment groups were carried out using an ANCOVA model adjusting for treatment, baseline NYHA class (NYHA II vs. III/IV) and the daily non-sedentary daytime activity baseline value as covariates.|ANCOVA|||Change from BL at Week 12 (FAS with LOCF)||6.14|-17.48|0.3463
72366084|NCT02900378|144243054|OTHER||Differences of least square means|-6.24|STANDARD_ERROR_OF_MEAN|6.69||0.3513|TWO_SIDED|95.0|-19.39|6.91||The comparison of treatment groups were carried out using an ANCOVA model adjusting for treatment, baseline NYHA class (NYHA II vs. III/IV) and the daily non-sedentary daytime activity baseline value as covariates.|ANCOVA|||Change from BL at Week 12 (FAS without MI/LOCF)||6.91|-19.39|0.3513
72366085|NCT02900378|144243055|OTHER||Odds Ratio (OR)|1.228|||||TWO_SIDED|95.0|0.882|1.708||||||FAS population||1.708|0.882|
72366086|NCT02900378|144243056|OTHER||Odds Ratio (OR)|1.251|||||TWO_SIDED|95.0|0.895|1.748||||||FAS subset without AE/SAE||1.748|0.895|
72366087|NCT02900378|144243057|OTHER||Odds Ratio (OR)|1.25|||||TWO_SIDED|95.0|0.634|2.464||||||FAS population||2.464|0.634|
72366088|NCT02900378|144243058|OTHER||Odds Ratio (OR)|1.28|||||TWO_SIDED|95.0|0.644|2.544||||||FAS subset without AE/SAE||2.544|0.644|
72366089|NCT02900378|144243059|OTHER||Odds Ratio (OR)|1.25|||||TWO_SIDED|95.0|0.863|1.811||||||FAS population||1.811|0.863|
72366090|NCT02900378|144243060|OTHER||Odds Ratio (OR)|1.26|||||TWO_SIDED|95.0|0.865|1.834||||||FAS subset without AE/SAE||1.834|0.865|
72366091|NCT02900378|144243061|OTHER|||||||0.1814|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 4 (FAS)||||0.1814
72366092|NCT02900378|144243061|OTHER|||||||0.3315|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 4 (FAS without AE/SAE)||||0.3315
72366093|NCT02900378|144243061|OTHER|||||||0.2414|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 8 (FAS)||||0.2414
72366094|NCT02900378|144243061|OTHER|||||||0.1793|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 8 (FAS without AE/SAE)||||0.1793
72366095|NCT02900378|144243062|OTHER||Odds Ratio (OR)|0.821|||||TWO_SIDED|95.0|0.462|1.457||||||Increased levels (\>= 10% increase) of non sedentary daytime physical activity at Week 12||1.457|0.462|
72366096|NCT02900378|144243063|OTHER|||||||0.0516|||||||Chi-squared|||Week 4||||0.0516
72366097|NCT02900378|144243063|OTHER|||||||0.9025|||||||Chi-squared|||Week 8||||0.9025
72366098|NCT02900378|144243063|OTHER|||||||0.6713|||||||Chi-squared|||Week 12||||0.6713
72366099|NCT02900378|144243064|OTHER|||||||0.0029|||||||Chi-squared|||Week 4||||0.0029
72366100|NCT02900378|144243064|OTHER|||||||0.7754|||||||Chi-squared|||Week 8||||0.7754
72366101|NCT02900378|144243064|OTHER|||||||0.2172|||||||Chi-squared|||Week 12||||0.2172
72366102|NCT02900378|144243065|OTHER|||||||0.0008|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 1||||0.0008
72366103|NCT02900378|144243065|OTHER|||||||0.0008|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 2||||0.0008
72366104|NCT02900378|144243065|OTHER|||||||0.0297|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 3||||0.0297
72366105|NCT02900378|144243065|OTHER|||||||0.0069|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 4||||0.0069
72366106|NCT02900378|144243065|OTHER|||||||0.2275|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 5||||0.2275
72366107|NCT02900378|144243065|OTHER|||||||0.3486|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 6||||0.3486
72366108|NCT02900378|144243065|OTHER|||||||0.68|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 7||||0.6800
72366109|NCT02900378|144243065|OTHER|||||||0.7184|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 8||||0.7184
72366110|NCT02900378|144243065|OTHER|||||||0.5301|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 9||||0.5301
72366111|NCT02900378|144243065|OTHER|||||||0.6019|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 10||||0.6019
72366112|NCT02900378|144243065|OTHER|||||||0.8229|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 11||||0.8229
72366113|NCT02900378|144243065|OTHER|||||||0.8229|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 12||||0.8229
72366114|NCT02900378|144243066|OTHER|||||||0.0001|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 2||||0.0001
72366115|NCT02900378|144243066|OTHER|||||||0.0123|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 4||||0.0123
72366116|NCT02900378|144243066|OTHER|||||||0.256|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 6||||0.2560
72366117|NCT02900378|144243066|OTHER|||||||0.5865|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 8||||0.5865
72366118|NCT02900378|144243066|OTHER|||||||0.5463|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 10||||0.5463
72366119|NCT02900378|144243066|OTHER|||||||0.3212|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 12||||0.3212
72366120|NCT02900378|144243067|OTHER|||||||0.0004|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 1||||0.0004
72366121|NCT02900378|144243067|OTHER|||||||0.0009|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 2||||0.0009
72366122|NCT02900378|144243067|OTHER|||||||0.0094|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 3||||0.0094
72366123|NCT02900378|144243067|OTHER|||||||0.0301|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 4||||0.0301
72366124|NCT02900378|144243067|OTHER|||||||0.1557|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 5||||0.1557
72366125|NCT02900378|144243067|OTHER|||||||0.6461|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 6||||0.6461
72366126|NCT02900378|144243067|OTHER|||||||0.9759|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 7||||0.9759
72366127|NCT02900378|144243067|OTHER|||||||0.3941|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 8||||0.3941
72366128|NCT02900378|144243067|OTHER|||||||0.7209|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 9||||0.7209
72366129|NCT02900378|144243067|OTHER|||||||0.4444|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 10||||0.4444
72366130|NCT02900378|144243067|OTHER|||||||0.7247|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 11||||0.7247
72366131|NCT02900378|144243067|OTHER|||||||0.2933|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 12||||0.2933
72366132|NCT02900378|144243068|OTHER|||||||0.0854|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 1||||0.0854
72366133|NCT02900378|144243068|OTHER|||||||0.0528|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 2||||0.0528
72366134|NCT02900378|144243068|OTHER|||||||0.4137|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 3||||0.4137
72366135|NCT02900378|144243068|OTHER|||||||0.0082|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 4||||0.0082
72366136|NCT02900378|144243068|OTHER|||||||0.7908|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 5||||0.7908
72366137|NCT02900378|144243068|OTHER|||||||0.6499|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 6||||0.6499
72366138|NCT02900378|144243068|OTHER|||||||0.5547|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 7||||0.5547
72366139|NCT02900378|144243068|OTHER|||||||0.6961|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 8||||0.6961
72366140|NCT02900378|144243068|OTHER|||||||0.5946|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 9||||0.5946
72366141|NCT02900378|144243068|OTHER|||||||0.8957|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 10||||0.8957
72366142|NCT02900378|144243068|OTHER|||||||0.8468|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 11||||0.8468
72366143|NCT02900378|144243068|OTHER|||||||0.1711|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 12||||0.1711
72366144|NCT02900378|144243069|OTHER|||||||0.0065|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 1||||0.0065
72366145|NCT02900378|144243069|OTHER|||||||0.0316|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 2||||0.0316
72366146|NCT02900378|144243069|OTHER|||||||0.1342|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 3||||0.1342
72366147|NCT02900378|144243069|OTHER|||||||0.0252|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 4||||0.0252
72366148|NCT02900378|144243069|OTHER|||||||0.9024|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 5||||0.9024
72366149|NCT02900378|144243069|OTHER|||||||0.9052|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 6||||0.9052
72366150|NCT02900378|144243069|OTHER|||||||0.287|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 7||||0.2870
72366151|NCT02900378|144243069|OTHER|||||||0.3174|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 8||||0.3174
72366152|NCT02900378|144243069|OTHER|||||||0.502|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 9||||0.5020
72366153|NCT02900378|144243069|OTHER|||||||0.4037|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 10||||0.4037
72366154|NCT02900378|144243069|OTHER|||||||0.4823|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 11||||0.4823
72366155|NCT02900378|144243069|OTHER|||||||0.109|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 12||||0.1090
72366156|NCT02900378|144243070|OTHER|||||||0.0061|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 1||||0.0061
72366157|NCT02900378|144243070|OTHER|||||||0.0143|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 2||||0.0143
72366158|NCT02900378|144243070|OTHER|||||||0.0708|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 3||||0.0708
72366159|NCT02900378|144243070|OTHER|||||||0.075|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 4||||0.0750
72366160|NCT02900378|144243070|OTHER|||||||0.8017|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 5||||0.8017
72366161|NCT02900378|144243070|OTHER|||||||0.7956|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 6||||0.7956
72366162|NCT02900378|144243070|OTHER|||||||0.3499|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 7||||0.3499
72366163|NCT02900378|144243070|OTHER|||||||0.1192|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 8||||0.1192
72366164|NCT02900378|144243070|OTHER|||||||0.5237|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 9||||0.5237
72366165|NCT02900378|144243070|OTHER|||||||0.3902|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 10||||0.3902
72366166|NCT02900378|144243070|OTHER|||||||0.4228|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 11||||0.4228
72366167|NCT02900378|144243070|OTHER|||||||0.1571|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 12||||0.1571
72366168|NCT02900378|144243071|OTHER|||||||0.3231|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 1||||0.3231
72366169|NCT02900378|144243071|OTHER|||||||0.3519|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 2||||0.3519
72366170|NCT02900378|144243071|OTHER|||||||0.8335|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 3||||0.8335
72366171|NCT02900378|144243071|OTHER|||||||0.0465|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 4||||0.0465
72366172|NCT02900378|144243071|OTHER|||||||0.5016|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 5||||0.5016
72366173|NCT02900378|144243071|OTHER|||||||0.5941|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 6||||0.5941
72366174|NCT02900378|144243071|OTHER|||||||0.2019|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 7||||0.2019
72366175|NCT02900378|144243071|OTHER|||||||0.4125|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 8||||0.4125
72366176|NCT02900378|144243071|OTHER|||||||0.5702|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 9||||0.5702
72366177|NCT02900378|144243071|OTHER|||||||0.4752|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 10||||0.4752
72366178|NCT02900378|144243071|OTHER|||||||0.5343|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 11||||0.5343
72366179|NCT02900378|144243071|OTHER|||||||0.0985|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 12||||0.0985
72366180|NCT02900378|144243072|OTHER|||||||0.4525|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 2||||0.4525
72366181|NCT02900378|144243072|OTHER|||||||0.0445|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 4||||0.0445
72366182|NCT02900378|144243072|OTHER|||||||0.1158|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 6||||0.1158
72366183|NCT02900378|144243072|OTHER|||||||0.3901|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 8||||0.3901
72366184|NCT02900378|144243072|OTHER|||||||0.7725|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 12||||0.7725
72366185|NCT03060096|144243109|SUPERIORITY|||||||0.29|||||||Fisher Exact|||||||0.29
72366186|NCT03060096|144243110|SUPERIORITY|||||||0.8|||||||t-test, 2 sided|||||||0.8
72366187|NCT03060096|144243111|OTHER||Rate|0.764|||||ONE_SIDED|95.0|0.6783||||||||||0.6783|
72366188|NCT01967940|144243129|SUPERIORITY|Enrollment into this study was stopped early due to the challenge of recruiting a sufficient number of participants who met the eligibility criteria. The actual number of enrolled is 55, among them 43 enrolled in the Randomized Cohort. Based on the actual enrollment numbers, the power to detect a 35% difference drops to 51%, under the same assumptions in the original sample size calculations.|Difference in proportions|60.7|||<|0.001|TWO_SIDED|95.0|42.6|78.8|||Fisher Exact||The 95% confidence interval was estimated based on unconditional exact method using 2 inverted 1-sided tests with the standardized statistic.|A sample size of 90 participants, randomized in a 2:1 ratio, achieves 89% power to detect a 35% difference in the proportion of participants with HIV-1 RNA decreases from baseline exceeding 0.5 log10 between the TAF and placebo arms at Day 10. Sample size and power computation was based on the assumption that 50% of participants in the TAF arm and 15% of participants in the placebo arm achieved a reduction exceeding 0.5 log10 HIV-1 RNA.||78.8|42.6|<0.001
72366189|NCT04266717|144243175|SUPERIORITY|||||||0.016|||||||Wilcoxon (Mann-Whitney)|||||||0.016
72366190|NCT00940771|144243176|OTHER|Friedman's Test|Chi Square|12.3||||0.006|TWO_SIDED||||||Friedman's Test|3 degrees of freedom.||||||.006
72366191|NCT00940771|144243176|OTHER|Post Hoc testing Post hoc Wilcoxon Signed Rank tests||||||0.007|||||||Wilcoxon Signed Rank|Z=-2.701||Nul lHypothesis that there is no difference between specific time points.||||.007
72366192|NCT00940771|144243177|OTHER|Friedman's test with 3 df||||||0.356|||||||Friedman's Test|3 degrees of freedom||||||.356
72366193|NCT00940771|144243178|OTHER||Chi-square|1.0||||0.801|TWO_SIDED||||||Friedman's test|3 degrees of freedom|1.0 is the actual calculated Chi-X value, not the p value.|The null hypothesis was that there was a difference. We were looking for no difference between before and after switch.||||.801
72366194|NCT00940771|144243179|OTHER|Friedman's test||||||0.075||||||a priori threshold for statistical significance 0.05|Friedman's test|3 degrees of freedom||||||.075
72366195|NCT02593006|144243188|SUPERIORITY||Risk Difference (RD)|10.3|||>|0.05|TWO_SIDED|95.0|-3.2|23.8|||Propensity weighted regression model|||||23.8|-3.2|>0.05
72366196|NCT02593006|144243189|SUPERIORITY|||||||0.04||||||Global test of interaction between time and treatment group.|Mixed Models Analysis|||||||0.04
72366197|NCT02420821|144243197|SUPERIORITY||Hazard Ratio (HR)|0.73||||0.0205|TWO_SIDED|95.0|0.57|0.95|||Log Rank||Hazard ratio was estimated by Cox regression.|Stratified Analysis: Strata were presence of liver metastases, Motzer score, PD-L1 level per interactive voice/web response system (IxRS).||0.95|0.57|0.0205
72366198|NCT02420821|144243199|SUPERIORITY||Hazard Ratio (HR)|0.91||||0.2675|TWO_SIDED|95.0|0.76|1.08|||Log Rank||Hazard ratio was estimated by Cox regression.|Stratified Analysis: Strata were presence of liver metastases, Motzer score, PD-L1 level per interactive voice/web response system (IxRS).||1.08|0.76|0.2675
72366199|NCT02420821|144243201|SUPERIORITY||Hazard Ratio (HR)|0.85||||0.263|TWO_SIDED|95.0|0.64|1.13|||Log Rank||Hazard ratio was estimated by Cox regression.|Stratified Analysis: Strata were presence of liver metastases, Motzer score, PD-L1 level per interactive voice/web response system (IxRS).||1.13|0.64|0.263
72366200|NCT02420821|144243203|SUPERIORITY||Hazard Ratio (HR)|0.88||||0.1218|TWO_SIDED|95.0|0.74|1.04|||Log Rank||Hazard ratio was estimated by Cox regression.|Stratified Analysis: Strata were presence of liver metastases, Motzer score, PD-L1 level per interactive voice/web response system (IxRS).||1.04|0.74|0.1218
72366201|NCT02420821|144243205|SUPERIORITY||Hazard Ratio (HR)|0.93||||0.6138|TWO_SIDED|95.0|0.72|1.21|||Log Rank||Hazard ratio was estimated by Cox regression.|Stratified Analysis: Strata were presence of liver metastases, Motzer score, PD-L1 level per interactive voice/web response system (IxRS).||1.21|0.72|0.6138
72366202|NCT02420821|144243206|SUPERIORITY||Difference in Response Rates|3.3||||0.2733|TWO_SIDED|95.0|-3.09|9.7|||Cochran-Mantel-Haenszel||95% CI for difference in response rates was constructed using Wald method.|Stratified Analysis: Strata were presence of liver metastases, Motzer score, PD-L1 level per interactive voice/web response system (IxRS).||9.70|-3.09|0.2733
72366203|NCT02420821|144243208|SUPERIORITY||Difference in Response Rates|1.96||||0.5121|TWO_SIDED|95.0|-4.32|8.24|||Cochran-Mantel-Haenszel||95% CI for difference in response rates was constructed using Wald method.|Stratified Analysis: Strata were presence of liver metastases, Motzer score, PD-L1 level per interactive voice/web response system (IxRS).||8.24|-4.32|0.5121
72366204|NCT02420821|144243211|SUPERIORITY||Hazard Ratio (HR)|0.85||||0.0606|TWO_SIDED|95.0|0.71|1.01|||Log Rank||Hazard ratio was estimated by Cox regression.|Stratified Analysis: Strata were presence of liver metastases, Motzer score, PD-L1 level per interactive voice/web response system (IxRS).||1.01|0.71|0.0606
72366205|NCT02420821|144243212|SUPERIORITY||Difference in Response Rates|5.09||||0.1011|TWO_SIDED|95.0|-1.4|11.58|||Cochran-Mantel-Haenszel||95% CI for difference in response rates was constructed using Wald method.|Stratified Analysis: Strata were presence of liver metastases, Motzer score, PD-L1 level per interactive voice/web response system (IxRS).||11.58|-1.40|0.1011
72366206|NCT02420821|144243215|SUPERIORITY||Hazard Ratio (HR)|0.83||||0.0254|TWO_SIDED|95.0|0.7|0.98|||Log Rank||Hazard ratio was estimated by Cox regression.|Stratified Analysis: Strata were presence of liver metastases, Motzer score, PD-L1 level per interactive voice/web response system (IxRS).||0.98|0.70|0.0254
72366207|NCT02420821|144243217|SUPERIORITY||Hazard Ratio (HR)|0.52||||0.002|TWO_SIDED|95.0|0.34|0.79|||Log Rank||Hazard ratio was estimated by Cox regression.|Stratified Analysis: Strata were presence of liver metastases, Motzer score, PD-L1 level per interactive voice/web response system (IxRS).||0.79|0.34|0.0020
72366208|NCT02420821|144243219|SUPERIORITY||Hazard Ratio (HR)|0.66||||0.0497|TWO_SIDED|95.0|0.43|1.0|||Log Rank||Hazard ratio was estimated by Cox regression.|Stratified Analysis: Strata were presence of liver metastases, Motzer score, PD-L1 level per interactive voice/web response system (IxRS).||1.00|0.43|0.0497
72366209|NCT02420821|144243220|SUPERIORITY||LS Mean Difference|-0.74|||<|0.0001|TWO_SIDED|95.0|-1.06|-0.43|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 1 Day 22: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||-0.43|-1.06|<0.0001
72366210|NCT02420821|144243220|SUPERIORITY||LS Mean Difference|-0.2||||0.2085|TWO_SIDED|95.0|-0.51|0.11|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 2 Day 1: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||0.11|-0.51|0.2085
72366211|NCT02420821|144243220|SUPERIORITY||LS Mean Difference|-1.02|||<|0.0001|TWO_SIDED|95.0|-1.33|-0.71|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 2 Day 22: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||-0.71|-1.33|<0.0001
72366212|NCT02420821|144243220|SUPERIORITY||LS Mean Difference|-0.51||||0.0013|TWO_SIDED|95.0|-0.82|-0.2|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 3 Day 1: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||-0.20|-0.82|0.0013
72366213|NCT02420821|144243220|SUPERIORITY||LS Mean Difference|-1.02|||<|0.0001|TWO_SIDED|95.0|-1.34|-0.7|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 3 Day 22: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||-0.70|-1.34|<0.0001
72366214|NCT02420821|144243220|SUPERIORITY||LS Mean Difference|-0.43||||0.0098|TWO_SIDED|95.0|-0.76|-0.1|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 4 Day 1: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||-0.10|-0.76|0.0098
72366215|NCT02420821|144243220|SUPERIORITY||LS Mean Difference|-0.98|||<|0.0001|TWO_SIDED|95.0|-1.32|-0.65|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 4 Day 22: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||-0.65|-1.32|<0.0001
72366216|NCT02420821|144243220|SUPERIORITY||LS Mean Difference|-0.46||||0.008|TWO_SIDED|95.0|-0.8|-0.12|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 5 Day 1: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||-0.12|-0.80|0.0080
72366217|NCT02420821|144243220|SUPERIORITY||LS Mean Difference|-0.78|||<|0.0001|TWO_SIDED|95.0|-1.13|-0.44|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 5 Day 22: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||-0.44|-1.13|<0.0001
72366218|NCT02420821|144243220|SUPERIORITY||LS Mean Difference|-0.21||||0.2512|TWO_SIDED|95.0|-0.56|0.15|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 6 Day 1: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||0.15|-0.56|0.2512
72366219|NCT02420821|144243220|SUPERIORITY||LS Mean Difference|-0.65||||0.0005|TWO_SIDED|95.0|-1.01|-0.28|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 6 Day 22: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||-0.28|-1.01|0.0005
72366220|NCT02420821|144243220|SUPERIORITY||LS Mean Difference|-0.43||||0.0247|TWO_SIDED|95.0|-0.8|-0.05|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 7 Day 1: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||-0.05|-0.80|0.0247
72366221|NCT02420821|144243220|SUPERIORITY||LS Mean Difference|-0.77|||<|0.0001|TWO_SIDED|95.0|-1.15|-0.39|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 7 Day 22: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||-0.39|-1.15|<0.0001
72431772|NCT01323660|144375438|SUPERIORITY_OR_OTHER||Least squares mean difference|65.8||||0.005|TWO_SIDED|95.0|20.3|111.3|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least square mean change difference=UMEC/VI 125/25 µg minus Placebo.|||111.3|20.3|0.005
72366222|NCT02420821|144243220|SUPERIORITY||LS Mean Difference|-0.29||||0.1411|TWO_SIDED|95.0|-0.68|0.1|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 8 Day 1: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||0.10|-0.68|0.1411
72366223|NCT02420821|144243220|SUPERIORITY||LS Mean Difference|-0.65||||0.0014|TWO_SIDED|95.0|-1.05|-0.25|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 8 Day 22: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||-0.25|-1.05|0.0014
72366224|NCT02420821|144243220|SUPERIORITY||LS Mean Difference|-0.37||||0.0728|TWO_SIDED|95.0|-0.78|0.03|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 9 Day 1: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||0.03|-0.78|0.0728
72366225|NCT02420821|144243220|SUPERIORITY||LS Mean Difference|-0.9|||<|0.0001|TWO_SIDED|95.0|-1.32|-0.49|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 9 Day 22: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||-0.49|-1.32|<0.0001
72366226|NCT02420821|144243220|SUPERIORITY||LS Mean Difference|-0.62||||0.0041|TWO_SIDED|95.0|-1.05|-0.2|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 10 Day 1: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||-0.20|-1.05|0.0041
72366227|NCT02420821|144243220|SUPERIORITY||LS Mean Difference|-1.0|||<|0.0001|TWO_SIDED|95.0|-1.46|-0.55|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 10 Day 22: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||-0.55|-1.46|<0.0001
72366228|NCT02420821|144243220|SUPERIORITY||LS Mean Difference|-0.5||||0.0353|TWO_SIDED|95.0|-0.96|-0.03|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 11 Day 1: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||-0.03|-0.96|0.0353
72366229|NCT02420821|144243220|SUPERIORITY||LS Mean Difference|-0.85||||0.0011|TWO_SIDED|95.0|-1.35|-0.34|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 11 Day 22: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||-0.34|-1.35|0.0011
72366230|NCT02420821|144243220|SUPERIORITY||LS Mean Difference|-0.5||||0.0582|TWO_SIDED|95.0|-1.01|0.02|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 12 Day 1: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||0.02|-1.01|0.0582
72366231|NCT02420821|144243220|SUPERIORITY||LS Mean Difference|-0.76||||0.0089|TWO_SIDED|95.0|-1.32|-0.19|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 12 Day 22: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||-0.19|-1.32|0.0089
72366232|NCT02420821|144243220|SUPERIORITY||LS Mean Difference|0.02||||0.9575|TWO_SIDED|95.0|-0.57|0.61|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 13 Day 1: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||0.61|-0.57|0.9575
72366233|NCT02420821|144243220|SUPERIORITY||LS Mean Difference|-0.36||||0.2745|TWO_SIDED|95.0|-1.01|0.29|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 13 Day 22: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||0.29|-1.01|0.2745
72431773|NCT01323660|144375439|SUPERIORITY_OR_OTHER||Least squares mean difference|0.144|||<|0.001|TWO_SIDED|95.0|0.086|0.203|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least square mean change difference=UMEC 62.5 µg minus Placebo.|||0.203|0.086|<0.001
72366234|NCT02420821|144243220|SUPERIORITY||LS Mean Difference|-0.13||||0.7088|TWO_SIDED|95.0|-0.81|0.55|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 14 Day 1: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||0.55|-0.81|0.7088
72366235|NCT02420821|144243220|SUPERIORITY||LS Mean Difference|-0.39||||0.3077|TWO_SIDED|95.0|-1.13|0.36|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 14 Day 22: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||0.36|-1.13|0.3077
72366236|NCT02420821|144243220|SUPERIORITY||LS Mean Difference|-0.15||||0.7112|TWO_SIDED|95.0|-0.93|0.63|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 15 Day 1: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||0.63|-0.93|0.7112
72366237|NCT02420821|144243220|SUPERIORITY||LS Mean Difference|-0.79||||0.0837|TWO_SIDED|95.0|-1.69|0.11|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 15 Day 22: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||0.11|-1.69|0.0837
72366238|NCT02420821|144243220|SUPERIORITY||LS Mean Difference|0.08||||0.8655|TWO_SIDED|95.0|-0.88|1.04|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 16 Day 1: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||1.04|-0.88|0.8655
72366239|NCT02420821|144243220|SUPERIORITY||LS Mean Difference|0.02||||0.9725|TWO_SIDED|95.0|-1.07|1.11|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 16 Day 22: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||1.11|-1.07|0.9725
72366240|NCT02420821|144243220|SUPERIORITY||LS Mean Difference|0.38||||0.5285|TWO_SIDED|95.0|-0.8|1.55|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 17 Day 1: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||1.55|-0.80|0.5285
72366241|NCT02420821|144243220|SUPERIORITY||LS Mean Difference|0.03||||0.9663|TWO_SIDED|95.0|-1.34|1.4|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 17 Day 22: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||1.40|-1.34|0.9663
72366242|NCT02420821|144243220|SUPERIORITY||LS Mean Difference|0.01||||0.9914|TWO_SIDED|95.0|-1.61|1.63|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 18 Day 1: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||1.63|-1.61|0.9914
72366243|NCT02420821|144243220|SUPERIORITY||LS Mean Difference|0.22||||0.8345|TWO_SIDED|95.0|-1.85|2.3|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 18 Day 22: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||2.30|-1.85|0.8345
72366244|NCT02420821|144243220|SUPERIORITY||LS Mean Difference|0.5||||0.7725|TWO_SIDED|95.0|-2.9|3.91|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 19 Day 1: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||3.91|-2.90|0.7725
72366245|NCT02420821|144243221|SUPERIORITY||LS Mean Difference|-0.49||||0.001|TWO_SIDED|95.0|-0.77|-0.2|||Mixed Models Analysis||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Pain: Mixed-effects model, assuming unstructured covariance matrix, with a term for treatment group, a term for visit time as a continuous variable, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model. The random effects are intercept and slope of visit time.||-0.20|-0.77|0.0010
72431774|NCT01323660|144375439|SUPERIORITY_OR_OTHER||Least squares mean difference|0.255|||<|0.001|TWO_SIDED|95.0|0.193|0.318|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least square mean change difference=UMEC 125 µg minus Placebo.|||0.318|0.193|<0.001
72366246|NCT02420821|144243221|SUPERIORITY||LS Mean Difference|-0.63|||<|0.0001|TWO_SIDED|95.0|-0.91|-0.34|||Mixed Models Analysis||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Fatigue: Mixed-effects model, assuming unstructured covariance matrix, with a term for treatment group, a term for visit time as a continuous variable, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model. The random effects are intercept and slope of visit time.||-0.34|-0.91|<0.0001
72366247|NCT02420821|144243221|SUPERIORITY||LS Mean Difference|-0.91|||<|0.0001|TWO_SIDED|95.0|-1.13|-0.69|||Mixed Models Analysis||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Nausea: Mixed-effects model, assuming unstructured covariance matrix, with a term for treatment group, a term for visit time as a continuous variable, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model. The random effects are intercept and slope of visit time.||-0.69|-1.13|<0.0001
72366248|NCT02420821|144243221|SUPERIORITY||LS Mean Difference|-0.52||||0.0002|TWO_SIDED|95.0|-0.79|-0.25|||Mixed Models Analysis||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Disturbed sleep: Mixed-effects model, assuming unstructured covariance matrix, with a term for treatment group, a term for visit time as a continuous variable, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model. The random effects are intercept and slope of visit time.||-0.25|-0.79|0.0002
72366249|NCT02420821|144243221|SUPERIORITY||LS Mean Difference|-0.56|||<|0.0001|TWO_SIDED|95.0|-0.84|-0.29|||Mixed Models Analysis||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Feelings of being distressed: Mixed-effects model, assuming unstructured covariance matrix, with a term for treatment group, a term for visit time as a continuous variable, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model. The random effects are intercept and slope of visit time.||-0.29|-0.84|<0.0001
72366250|NCT02420821|144243221|SUPERIORITY||LS Mean Difference|-0.56|||<|0.0001|TWO_SIDED|95.0|-0.81|-0.32|||Mixed Models Analysis||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Shortness of breath: Mixed-effects model, assuming unstructured covariance matrix, with a term for treatment group, a term for visit time as a continuous variable, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model. The random effects are intercept and slope of visit time.||-0.32|-0.81|<0.0001
72366251|NCT02420821|144243221|SUPERIORITY||LS Mean Difference|-0.33||||0.0036|TWO_SIDED|95.0|-0.56|-0.11|||Mixed Models Analysis||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Remembering things: Mixed-effects model, assuming unstructured covariance matrix, with a term for treatment group, a term for visit time as a continuous variable, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model. The random effects are intercept and slope of visit time.||-0.11|-0.56|0.0036
72366252|NCT02420821|144243221|SUPERIORITY||LS Mean Difference|-1.19|||<|0.0001|TWO_SIDED|95.0|-1.46|-0.91|||Mixed Models Analysis||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Lack of appetite: Mixed-effects model, assuming unstructured covariance matrix, with a term for treatment group, a term for visit time as a continuous variable, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model. The random effects are intercept and slope of visit time.||-0.91|-1.46|<0.0001
72366253|NCT02420821|144243221|SUPERIORITY||LS Mean Difference|-0.54||||0.0001|TWO_SIDED|95.0|-0.81|-0.27|||Mixed Models Analysis||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Drowsy: Mixed-effects model, assuming unstructured covariance matrix, with a term for treatment group, a term for visit time as a continuous variable, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model. The random effects are intercept and slope of visit time.||-0.27|-0.81|0.0001
72366254|NCT02420821|144243221|SUPERIORITY||LS Mean Difference|-1.0|||<|0.0001|TWO_SIDED|95.0|-1.28|-0.71|||Mixed Models Analysis||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Dry mouth: Mixed-effects model, assuming unstructured covariance matrix, with a term for treatment group, a term for visit time as a continuous variable, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model. The random effects are intercept and slope of visit time.||-0.71|-1.28|<0.0001
72366255|NCT02420821|144243221|SUPERIORITY||LS Mean Difference|-0.6|||<|0.0001|TWO_SIDED|95.0|-0.87|-0.33|||Mixed Models Analysis||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Feeling sad: Mixed-effects model, assuming unstructured covariance matrix, with a term for treatment group, a term for visit time as a continuous variable, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model. The random effects are intercept and slope of visit time.||-0.33|-0.87|<0.0001
72366256|NCT02420821|144243221|SUPERIORITY||LS Mean Difference|-0.58|||<|0.0001|TWO_SIDED|95.0|-0.75|-0.41|||Mixed Models Analysis||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Vomiting: Mixed-effects model, assuming unstructured covariance matrix, with a term for treatment group, a term for visit time as a continuous variable, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model. The random effects are intercept and slope of visit time.||-0.41|-0.75|<0.0001
72366257|NCT02420821|144243221|SUPERIORITY||LS Mean Difference|-0.34||||0.0051|TWO_SIDED|95.0|-0.58|-0.1|||Mixed Models Analysis||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Numbness or tingling: Mixed-effects model, assuming unstructured covariance matrix, with a term for treatment group, a term for visit time as a continuous variable, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model. The random effects are intercept and slope of visit time.||-0.10|-0.58|0.0051
72431775|NCT01323660|144375439|SUPERIORITY_OR_OTHER||Least squares mean difference|0.112|||<|0.001||95.0|0.061|0.163|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least square mean change difference=VI 25 µg minus Placebo.|||0.163|0.061|<0.001
72366258|NCT02420821|144243221|SUPERIORITY||LS Mean Difference|-1.08|||<|0.0001|TWO_SIDED|95.0|-1.33|-0.83|||Mixed Models Analysis||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Rash/Skin Changes: Mixed-effects model, assuming unstructured covariance matrix, with a term for treatment group, a term for visit time as a continuous variable, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model. The random effects are intercept and slope of visit time.||-0.83|-1.33|<0.0001
72366259|NCT02420821|144243221|SUPERIORITY||LS Mean Difference|-0.05||||0.6541|TWO_SIDED|95.0|-0.26|0.16|||Mixed Models Analysis||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Headache: Mixed-effects model, assuming unstructured covariance matrix, with a term for treatment group, a term for visit time as a continuous variable, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model. The random effects are intercept and slope of visit time.||0.16|-0.26|0.6541
72366260|NCT02420821|144243221|SUPERIORITY||LS Mean Difference|-1.02|||<|0.0001|TWO_SIDED|95.0|-1.28|-0.76|||Mixed Models Analysis||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Mouth/Throat Sores: Mixed-effects model, assuming unstructured covariance matrix, with a term for treatment group, a term for visit time as a continuous variable, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model. The random effects are intercept and slope of visit time.||-0.76|-1.28|<0.0001
72366261|NCT02420821|144243221|SUPERIORITY||LS Mean Difference|-1.07|||<|0.0001|TWO_SIDED|95.0|-1.27|-0.88|||Mixed Models Analysis||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Diarrhea: Mixed-effects model, assuming unstructured covariance matrix, with a term for treatment group, a term for visit time as a continuous variable, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model. The random effects are intercept and slope of visit time.||-0.88|-1.27|<0.0001
72366262|NCT02420821|144243224|SUPERIORITY||LS Mean Difference|0.73|||<|0.0001|TWO_SIDED|95.0|0.58|0.87|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 1 Day 22: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||0.87|0.58|<0.0001
72366263|NCT02420821|144243224|SUPERIORITY||LS Mean Difference|0.42|||<|0.0001|TWO_SIDED|95.0|0.28|0.57|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 2 Day 1: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||0.57|0.28|<0.0001
72366264|NCT02420821|144243224|SUPERIORITY||LS Mean Difference|0.7|||<|0.0001|TWO_SIDED|95.0|0.55|0.84|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 2 Day 22: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||0.84|0.55|<0.0001
72366265|NCT02420821|144243224|SUPERIORITY||LS Mean Difference|0.58|||<|0.0001|TWO_SIDED|95.0|0.44|0.73|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 3 Day 1: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||0.73|0.44|<0.0001
72366266|NCT02420821|144243224|SUPERIORITY||LS Mean Difference|0.77|||<|0.0001|TWO_SIDED|95.0|0.62|0.92|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 3 Day 22: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||0.92|0.62|<0.0001
72366267|NCT02420821|144243224|SUPERIORITY||LS Mean Difference|0.62|||<|0.0001|TWO_SIDED|95.0|0.46|0.78|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 4 Day 1: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||0.78|0.46|<0.0001
72366268|NCT02420821|144243224|SUPERIORITY||LS Mean Difference|0.82|||<|0.0001|TWO_SIDED|95.0|0.66|0.97|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 4 Day 22: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||0.97|0.66|<0.0001
72368809|NCT02637037|144247320|NON_INFERIORITY_OR_EQUIVALENCE|If the 90% CIs for both dapagliflozin and metformin geometric mean ratio of AUC is entirely contained within an 80.00% to 125.00% interval, it will be concluded the 2 manufacturing sites are bioequivalent.|Ratios of Geometric means|1.02|||||TWO_SIDED|90.0|0.97|1.08||||||Metformin: Statistical Assessment of Bioequivalence for Metformin following administration Dapagliflozin/Metformin XR 5/500 mg for Treatment A and B.||1.08|0.97|
72431776|NCT01323660|144375439|SUPERIORITY_OR_OTHER||Least squares mean difference|0.099|||<|0.001|TWO_SIDED|95.0|0.041|0.157|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least square mean change difference=UMEC/VI 62.5/25 µg minus UMEC 62.5 µg.|||0.157|0.041|<0.001
72366269|NCT02420821|144243224|SUPERIORITY||LS Mean Difference|0.65|||<|0.0001|TWO_SIDED|95.0|0.49|0.81|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 5 Day 1: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||0.81|0.49|<0.0001
72366270|NCT02420821|144243224|SUPERIORITY||LS Mean Difference|0.83|||<|0.0001|TWO_SIDED|95.0|0.66|0.99|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 5 Day 22: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||0.99|0.66|<0.0001
72366271|NCT02420821|144243224|SUPERIORITY||LS Mean Difference|0.63|||<|0.0001|TWO_SIDED|95.0|0.46|0.8|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 6 Day 1: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||0.80|0.46|<0.0001
72366272|NCT02420821|144243224|SUPERIORITY||LS Mean Difference|0.72|||<|0.0001|TWO_SIDED|95.0|0.54|0.89|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 6 Day 22: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||0.89|0.54|<0.0001
72366273|NCT02420821|144243224|SUPERIORITY||LS Mean Difference|0.47|||<|0.0001|TWO_SIDED|95.0|0.3|0.65|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 7 Day 1: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||0.65|0.30|<0.0001
72366274|NCT02420821|144243224|SUPERIORITY||LS Mean Difference|0.68|||<|0.0001|TWO_SIDED|95.0|0.49|0.86|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 7 Day 22: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||0.86|0.49|<0.0001
72366275|NCT02420821|144243224|SUPERIORITY||LS Mean Difference|0.47|||<|0.0001|TWO_SIDED|95.0|0.29|0.66|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 8 Day 1: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||0.66|0.29|<0.0001
72366276|NCT02420821|144243224|SUPERIORITY||LS Mean Difference|0.6|||<|0.0001|TWO_SIDED|95.0|0.41|0.79|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 8 Day 22: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||0.79|0.41|<0.0001
72366277|NCT02420821|144243224|SUPERIORITY||LS Mean Difference|0.49|||<|0.0001|TWO_SIDED|95.0|0.29|0.68|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 9 Day 1: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||0.68|0.29|<0.0001
72366278|NCT02420821|144243224|SUPERIORITY||LS Mean Difference|0.71|||<|0.0001|TWO_SIDED|95.0|0.52|0.91|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 9 Day 22: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||0.91|0.52|<0.0001
72366279|NCT02420821|144243224|SUPERIORITY||LS Mean Difference|0.53|||<|0.0001|TWO_SIDED|95.0|0.33|0.73|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 10 Day 1: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||0.73|0.33|<0.0001
72366280|NCT02420821|144243224|SUPERIORITY||LS Mean Difference|0.74|||<|0.0001|TWO_SIDED|95.0|0.51|0.96|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 10 Day 22: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||0.96|0.51|<0.0001
72431777|NCT01323660|144375439|SUPERIORITY_OR_OTHER||Least squares mean difference|0.132|||<|0.001|TWO_SIDED|95.0|0.081|0.183|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least square mean change difference=UMEC/VI 62.5/25 µg minus VI 25 µg.|||0.183|0.081|<0.001
72366281|NCT02420821|144243224|SUPERIORITY||LS Mean Difference|0.64|||<|0.0001|TWO_SIDED|95.0|0.41|0.86|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 11 Day 1: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||0.86|0.41|<0.0001
72366282|NCT02420821|144243224|SUPERIORITY||LS Mean Difference|0.74|||<|0.0001|TWO_SIDED|95.0|0.49|0.99|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 11 Day 22: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||0.99|0.49|<0.0001
72366283|NCT02420821|144243224|SUPERIORITY||LS Mean Difference|0.42||||0.001|TWO_SIDED|95.0|0.17|0.68|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 12 Day 1: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||0.68|0.17|0.0010
72366284|NCT02420821|144243224|SUPERIORITY||LS Mean Difference|0.6|||<|0.0001|TWO_SIDED|95.0|0.32|0.89|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 12 Day 22: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||0.89|0.32|<0.0001
72366285|NCT02420821|144243224|SUPERIORITY||LS Mean Difference|0.52||||0.0005|TWO_SIDED|95.0|0.23|0.82|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 13 Day 1: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||0.82|0.23|0.0005
72366286|NCT02420821|144243224|SUPERIORITY||LS Mean Difference|0.56||||0.0008|TWO_SIDED|95.0|0.23|0.88|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 13 Day 22: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||0.88|0.23|0.0008
72366287|NCT02420821|144243224|SUPERIORITY||LS Mean Difference|0.33||||0.0591|TWO_SIDED|95.0|-0.01|0.67|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 14 Day 1: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||0.67|-0.01|0.0591
72366288|NCT02420821|144243224|SUPERIORITY||LS Mean Difference|0.67||||0.0005|TWO_SIDED|95.0|0.29|1.05|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 14 Day 22: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||1.05|0.29|0.0005
72366289|NCT02420821|144243224|SUPERIORITY||LS Mean Difference|0.3||||0.1378|TWO_SIDED|95.0|-0.09|0.68|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 15 Day 1: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||0.68|-0.09|0.1378
72366290|NCT02420821|144243224|SUPERIORITY||LS Mean Difference|0.43||||0.065|TWO_SIDED|95.0|-0.03|0.89|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 15 Day 22: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||0.89|-0.03|0.0650
72366291|NCT02420821|144243224|SUPERIORITY||LS Mean Difference|0.48||||0.0531|TWO_SIDED|95.0|-0.01|0.96|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 16 Day 1: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||0.96|-0.01|0.0531
72366292|NCT02420821|144243224|SUPERIORITY||LS Mean Difference|0.93||||0.0011|TWO_SIDED|95.0|0.37|1.49|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 16 Day 22: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||1.49|0.37|0.0011
72431778|NCT01323660|144375439|SUPERIORITY_OR_OTHER||Least squares mean difference|0.006||||0.849|TWO_SIDED|95.0|-0.055|0.067|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least square mean change difference=UMEC/VI 125/25 µg minus UMEC 125 µg.|||0.067|-0.055|0.849
72366293|NCT02420821|144243224|SUPERIORITY||LS Mean Difference|0.55||||0.0708|TWO_SIDED|95.0|-0.05|1.14|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 17 Day 1: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||1.14|-0.05|0.0708
72366294|NCT02420821|144243224|SUPERIORITY||LS Mean Difference|0.58||||0.1078|TWO_SIDED|95.0|-0.13|1.29|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 17 Day 22: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||1.29|-0.13|0.1078
72366295|NCT02420821|144243224|SUPERIORITY||LS Mean Difference|0.62||||0.1487|TWO_SIDED|95.0|-0.22|1.47|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 18 Day 1: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||1.47|-0.22|0.1487
72366296|NCT02420821|144243224|SUPERIORITY||LS Mean Difference|0.33||||0.5537|TWO_SIDED|95.0|-0.77|1.43|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 18 Day 22: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||1.43|-0.77|0.5537
72366297|NCT02420821|144243224|SUPERIORITY||LS Mean Difference|0.52||||0.5743|TWO_SIDED|95.0|-1.29|2.33|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 19 Day 1: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||2.33|-1.29|0.5743
72366298|NCT01929317|144243257|SUPERIORITY_OR_OTHER||Mean change from Baseline|-4.8|||<|0.001|TWO_SIDED|95.0|-6.3|-3.2|||t-test, 1 sided|||||-3.2|-6.3|<0.001
72366299|NCT01929317|144243258|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|||||TWO_SIDED|95.0|-2.4|2.0|||||Estimated value and CI are presented for the change from Baseline in Japanese UPDRS Part III total score for Week 2.|||2.0|-2.4|
72366300|NCT01929317|144243258|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.6|||||TWO_SIDED|95.0|-1.9|3.1|||||Estimated value and CI are presented for the change from Baseline in Japanese UPDRS Part III total score for Week 4.|||3.1|-1.9|
72366301|NCT01929317|144243258|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3|||||TWO_SIDED|95.0|-2.3|3.0|||||Estimated value and CI are presented for the change from Baseline in Japanese UPDRS Part III total score for Week 6.|||3.0|-2.3|
72366302|NCT01929317|144243258|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7|||||TWO_SIDED|95.0|-3.4|2.0|||||Estimated value and CI are presented for the change from Baseline in Japanese UPDRS Part III total score for Week 8.|||2.0|-3.4|
72366303|NCT01929317|144243258|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.9|||||TWO_SIDED|95.0|-2.0|3.9|||||Estimated value and CI are presented for the change from Baseline in Japanese UPDRS Part III total score for Week 12.|||3.9|-2.0|
72366304|NCT01929317|144243260|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1|||||TWO_SIDED|95.0|-0.2|0.3|||||Estimated value and CI are presented for the change from Baseline in Japanese UPDRS Part 1 total score for Week 2.|||0.3|-0.2|
72366305|NCT01929317|144243260|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1|||||TWO_SIDED|95.0|-0.2|0.4|||||Estimated value and CI are presented for the change from Baseline in Japanese UPDRS Part 1 total score for Week 4.|||0.4|-0.2|
72366306|NCT01929317|144243260|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|||||TWO_SIDED|95.0|-0.4|0.3|||||Estimated value and CI are presented for the change from Baseline in Japanese UPDRS Part 1 total score for Week 6.|||0.3|-0.4|
72366307|NCT01929317|144243260|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|||||TWO_SIDED|95.0|-0.3|0.3|||||Estimated value and CI are presented for the change from Baseline in Japanese UPDRS Part 1 total score for Week 8.|||0.3|-0.3|
72366308|NCT01929317|144243260|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2|||||TWO_SIDED|95.0|-0.2|0.6|||||Estimated value and CI are presented for the change from Baseline in Japanese UPDRS Part 1 total score for Week 12.|||0.6|-0.2|
72366309|NCT01929317|144243261|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9|||||TWO_SIDED|95.0|-1.8|0.1|||||Estimated value and CI are presented for the change from Baseline in Japanese UPDRS Part 2 total score for Week 2, On status.|||0.1|-1.8|
72366310|NCT01929317|144243261|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.1|||||TWO_SIDED|95.0|-2.4|0.1|||||Estimated value and CI are presented for the change from Baseline in Japanese UPDRS Part 2 total score for Week 4, On status.|||0.1|-2.4|
72366311|NCT01929317|144243261|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.1|||||TWO_SIDED|95.0|-2.6|0.3|||||Estimated value and CI are presented for the change from Baseline in Japanese UPDRS Part 2 total score for Week 6, On status.|||0.3|-2.6|
72366312|NCT01929317|144243261|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.2|||||TWO_SIDED|95.0|-2.8|0.3|||||Estimated value and CI are presented for the change from Baseline in Japanese UPDRS Part 2 total score for Week 8, On status.|||0.3|-2.8|
72366313|NCT01929317|144243261|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0|||||TWO_SIDED|95.0|-2.7|0.7|||||Estimated value and CI are presented for the change from Baseline in Japanese UPDRS Part 2 total score for Week 12, On status.|||0.7|-2.7|
72366314|NCT01929317|144243261|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6|||||TWO_SIDED|95.0|-1.8|0.5|||||Estimated value and CI are presented for the change from Baseline in Japanese UPDRS Part 2 total score for Week 2, Off status.|||0.5|-1.8|
72366315|NCT01929317|144243261|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9|||||TWO_SIDED|95.0|-2.6|0.8|||||Estimated value and CI are presented for the change from Baseline in Japanese UPDRS Part 2 total score for Week 4, Off status.|||0.8|-2.6|
72366316|NCT01929317|144243261|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9|||||TWO_SIDED|95.0|-2.8|1.0|||||Estimated value and CI are presented for the change from Baseline in Japanese UPDRS Part 2 total score for Week 6, Off status.|||1.0|-2.8|
72366317|NCT01929317|144243261|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|||||TWO_SIDED|95.0|-2.1|1.8|||||Estimated value and CI are presented for the change from Baseline in Japanese UPDRS Part 2 total score for Week 8, Off status.|||1.8|-2.1|
72366318|NCT01929317|144243261|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|||||TWO_SIDED|95.0|-2.2|2.1|||||Estimated value and CI are presented for the change from Baseline in Japanese UPDRS Part 2 total score for Week 12, Off status.|||2.1|-2.2|
72366319|NCT01929317|144243262|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|||||TWO_SIDED|95.0|-0.7|0.4|||||Estimated value and CI are presented for the change from Baseline in Japanese UPDRS Part 4 total score for Week 2.|||0.4|-0.7|
72366320|NCT01929317|144243262|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|||||TWO_SIDED|95.0|-0.7|0.6|||||Estimated value and CI are presented for the change from Baseline in Japanese UPDRS Part 4 total score for Week 4.|||0.6|-0.7|
72366321|NCT01929317|144243262|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1|||||TWO_SIDED|95.0|-0.7|0.8|||||Estimated value and CI are presented for the change from Baseline in Japanese UPDRS Part 4 total score for Week 6.|||0.8|-0.7|
72366322|NCT01929317|144243262|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|||||TWO_SIDED|95.0|-0.7|0.7|||||Estimated value and CI are presented for the change from Baseline in Japanese UPDRS Part 4 total score for Week 8.|||0.7|-0.7|
72366323|NCT01929317|144243262|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|||||TWO_SIDED|95.0|-0.9|0.5|||||Estimated value and CI are presented for the change from Baseline in Japanese UPDRS Part 4 total score for Week 12.|||0.5|-0.9|
72366324|NCT01929317|144243275|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|||||TWO_SIDED|95.0|-1.65|1.04|||||"Estimated value and CI are presented for the change from Baseline in actual hours of awake time spent Off for Week 2."|||1.04|-1.65|
72366325|NCT01929317|144243275|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.05|||||TWO_SIDED|95.0|-1.34|1.45|||||"Estimated value and CI are presented for the change from Baseline in actual hours of awake time spent Off for Week 4."|||1.45|-1.34|
72366326|NCT01929317|144243275|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.35|||||TWO_SIDED|95.0|-1.95|1.24|||||"Estimated value and CI are presented for the change from Baseline in actual hours of awake time spent Off for Week 6."|||1.24|-1.95|
72366327|NCT01929317|144243275|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.85|||||TWO_SIDED|95.0|-2.44|0.75|||||"Estimated value and CI are presented for the change from Baseline in actual hours of awake time spent Off for Week 8."|||0.75|-2.44|
72366328|NCT01929317|144243275|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.07|||||TWO_SIDED|95.0|-2.73|0.58|||||"Estimated value and CI are presented for the change from Baseline in actual hours of awake time spent Off for Week 12."|||0.58|-2.73|
72366329|NCT01929317|144243276|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.03|||||TWO_SIDED|95.0|-8.77|6.71|||||"Estimated value and CI are presented for the change from Baseline in the proportion of awake time spent Off for Week 2."|||6.71|-8.77|
72366330|NCT01929317|144243276|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.14|||||TWO_SIDED|95.0|-7.94|8.22|||||"Estimated value and CI are presented for the change from Baseline in the proportion of awake time spent Off for Week 4."|||8.22|-7.94|
72366331|NCT01929317|144243276|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.78|||||TWO_SIDED|95.0|-12.06|6.49|||||"Estimated value and CI are presented for the change from Baseline in the proportion of awake time spent Off for Week 6."|||6.49|-12.06|
72366332|NCT01929317|144243276|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.46|||||TWO_SIDED|95.0|-14.06|5.14|||||"Estimated value and CI are presented for the change from Baseline in the proportion of awake time spent Off for Week 8."|||5.14|-14.06|
72366333|NCT01929317|144243276|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.98|||||TWO_SIDED|95.0|-15.92|3.96|||||"Estimated value and CI are presented for the change from Baseline in the proportion of awake time spent Off for Week 12."|||3.96|-15.92|
72366334|NCT01929317|144243277|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.07|||||TWO_SIDED|95.0|-1.07|1.21|||||"Estimated value and CI are presented for the change from Baseline in actual hours of awake time spent On for Week 2."|||1.21|-1.07|
72366335|NCT01929317|144243277|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.47|||||TWO_SIDED|95.0|-0.75|1.7|||||"Estimated value and CI are presented for the change from Baseline in actual hours of awake time spent On for Week 4."|||1.70|-0.75|
72366336|NCT01929317|144243277|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.6|||||TWO_SIDED|95.0|-0.65|1.86|||||"Estimated value and CI are presented for the change from Baseline in actual hours of awake time spent On for Week 6."|||1.86|-0.65|
72366337|NCT01929317|144243277|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.85|||||TWO_SIDED|95.0|-0.52|2.22|||||"Estimated value and CI are presented for the change from Baseline in actual hours of awake time spent On for Week 8."|||2.22|-0.52|
72366338|NCT01929317|144243277|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.86|||||TWO_SIDED|95.0|-0.55|2.26|||||"Estimated value and CI are presented for the change from Baseline in actual hours of awake time spent On for Week 12."|||2.26|-0.55|
72366339|NCT01929317|144243278|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.19|||||TWO_SIDED|95.0|-0.98|1.36|||||"Estimated value and CI are presented for the change from Baseline in actual hours of awake time spent On without troublesome dyskinesias for Week 2."|||1.36|-0.98|
72366340|NCT01929317|144243278|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.57|||||TWO_SIDED|95.0|-0.64|1.78|||||"Estimated value and CI are presented for the change from Baseline in actual hours of awake time spent On without troublesome dyskinesias for Week 4."|||1.78|-0.64|
72366341|NCT01929317|144243278|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.56|||||TWO_SIDED|95.0|-0.71|1.84|||||"Estimated value and CI are presented for the change from Baseline in actual hours of awake time spent On without troublesome dyskinesias for Week 6."|||1.84|-0.71|
72366342|NCT01929317|144243278|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.96|||||TWO_SIDED|95.0|-0.47|2.39|||||"Estimated value and CI are presented for the change from Baseline in actual hours of awake time spent On without troublesome dyskinesias for Week 8."|||2.39|-0.47|
72366343|NCT01929317|144243278|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.85|||||TWO_SIDED|95.0|-0.63|2.33|||||"Estimated value and CI are presented for the change from Baseline in actual hours of awake time spent On without troublesome dyskinesias for Week 12."|||2.33|-0.63|
72366344|NCT03326713|144243302|SUPERIORITY||Odds Ratio (OR)|6.2|||<|0.0001|TWO_SIDED|95.0|2.5|15.2|||Regression, Logistic|||Logistic Regression Model Results for Intervention Effects on CGRA Within 6 Months (TP vs TCN)||15.2|2.5|<.0001
72366345|NCT03326713|144243302|SUPERIORITY||Odds Ratio (OR)|7.4|||<|0.0001|TWO_SIDED|95.0|2.8|19.4|||Regression, Logistic|||Logistic Regression Model Results for Intervention Effects on CGRA Within 6 Months (UC vs TCN)||19.4|2.8|<.0001
72366346|NCT03326713|144243302|SUPERIORITY||Odds Ratio (OR)|1.2||||1.2|TWO_SIDED|95.0|0.4|4.0|||Regression, Logistic|||Logistic Regression Model Results for Intervention Effects on CGRA Within 6 Months (UC vs TP)||4.0|0.4|1.2
72366347|NCT01198977|144243317|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Power analyses were conducted with GPower 3 evaluating the a priori sample size required to detect a medium-sized effect (f= .25, Cohen, 1988) for Group XTime interaction on primary DV. Assuming two-tailed alpha=.05 and autocorrelations between repeated measures of r=.50, adequate power (.80) to detect medium sized. Group Time effect (f=.25) would be achieved with a total sample size of 28. Given the sample size of 64, observed power more than adequate (.99).||||||0.013||||||Baseline and 3-month follow-up for arm 1 and arm 2.|ANOVA|||||||.013
72366348|NCT01198977|144243317|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Power analyses were conducted with GPower 3 evaluating the a priori sample size required to detect a medium-sized effect (f= .25, Cohen, 1988) for Group XTime interaction on primary DV. Assuming two-tailed alpha=.05 and autocorrelations between repeated measures of r=.50, adequate power (.80) to detect medium sized. Group Time effect (f=.25) would be achieved with a total sample size of 28. Given the sample size of 64, observed power more than adequate (.99).||||||0.005||||||Comparing baseline to 6-month follow-up.|ANOVA|||||||0.005
72366349|NCT01198977|144243317|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Power analyses were conducted with GPower 3 evaluating the a priori sample size required to detect a medium-sized effect (f= .25, Cohen, 1988) for Group XTime interaction on primary DV. Assuming two-tailed alpha=.05 and autocorrelations between repeated measures of r=.50, adequate power (.80) to detect medium sized. Group Time effect (f=.25) would be achieved with a total sample size of 28. Given the sample size of 64, observed power more than adequate (.99).||||||0.01||||||The interaction effect between the two conditions across time. Baseline, 3-month, 6-month.|ANOVA|||||||0.010
72366350|NCT01198977|144243318|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Power analyses were conducted with GPower 3 evaluating the a priori sample size required to detect a medium-sized effect (f= .25, Cohen, 1988) for Group XTime interaction on primary DV. Assuming two-tailed alpha=.05 and autocorrelations between repeated measures of r=.50, adequate power (.80) to detect medium sized. Group Time effect (f=.25) would be achieved with a total sample size of 28. Given the sample size of 64, observed power more than adequate (.99).||||||0.009||||||Comparing depression scores for the telephone counseling and education counseling groups at 6 months.|ANOVA|||||||0.009
72366351|NCT01198977|144243318|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Power analyses were conducted with GPower 3 evaluating the a priori sample size required to detect a medium-sized effect (f= .25, Cohen, 1988) for Group X Time interaction on primary DV. Assuming two-tailed alpha=.05 and autocorrelations between repeated measures of r=.50, adequate power (.80) to detect medium sized. Group Time effect (f=.25) would be achieved with a total sample size of 28. Given the sample size of 64, observed power more than adequate (.99).||||||0.032||||||Interaction effects between the telephone counseling and education counseling groups over time (baseline, 3 months, 6 months).|ANOVA|||||||.032
72366352|NCT01198977|144243319|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Power analyses were conducted with GPower 3 evaluating the a priori sample size required to detect a medium-sized effect (f= .25, Cohen, 1988) for Group XTime interaction on primary DV. Assuming two-tailed alpha=.05 and autocorrelations between repeated measures of r=.50, adequate power (.80) to detect medium sized. Group Time effect (f=.25) would be achieved with a total sample size of 28. Given the sample size of 64, observed power more than adequate (.99).||||||0.049||||||Physical Activity Interaction effect between the Telephone Counseling and Education Counseling Group over time (baseline, 3 months, 6 months).|ANOVA|||||||0.049
72366353|NCT01198977|144243319|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Power analyses were conducted with GPower 3 evaluating the a priori sample size required to detect a medium-sized effect (f= .25, Cohen, 1988) for Group XTime interaction on primary DV. Assuming two-tailed alpha=.05 and autocorrelations between repeated measures of r=.50, adequate power (.80) to detect medium sized. Group Time effect (f=.25) would be achieved with a total sample size of 28. Given the sample size of 64, observed power more than adequate (.99).||||||0.014||||||Comparing physical activity scores for the telephone counseling and education counseling groups at 6 months.|ANOVA|||||||.014
72366354|NCT03397966|144243324|SUPERIORITY|||||||0.063||||||The investigators tested the effect of treatment (BNP vs. control) on the primary endpoint using mixed effects modeling, adjusting for treatment sequence, to assess the effect of treatment on each endpoint.|Mixed Models Analysis|||The primary endpoint is change in resting energy expenditure, calculated as final resting energy expenditure adjusted for baseline level, using linear regression. The null hypothesis is that there will be no significant effect of treatment on each endpoint. The investigators adhered to intention-to-treat principles. The test was performed with a significance level of 0.05.||||0.063
72366355|NCT03397966|144243325|SUPERIORITY|||||||0.07||||||Paired t-test.|t-test, 2 sided|||The null hypothesis is that there will be no significant effect of BNP on adipose gene expression of UCP1 compared with placebo. The alternative hypothesis is that UCP1 expression would be significantly higher after BNP treatment compared with placebo.||||0.07
72366356|NCT02864394|144243372|SUPERIORITY||Hazard Ratio (HR)|0.83||||0.1276|TWO_SIDED|95.0|0.61|1.14|||Log Rank|||Treatment comparison (Hazard Ratio, HR) based on Cox regression model with Efron's method of tie handling with treatment as a covariate. One-sided p-value was based on log-rank test.||1.14|0.61|0.1276
72366357|NCT02864394|144243373|OTHER||Hazard Ratio (HR)|0.75||||0.0076|TWO_SIDED|95.0|0.6|0.95|||Log Rank|||OS was not formally tested. Treatment comparison (HR) based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by PD-L1 expression status (TPS ≥50% vs. TPS 1-49%). A nominal one-sided p-value for testing was based on log-rank test stratified by PD-L1 expression status (TPS ≥50% vs. TPS 1-49%).||0.95|0.60|0.0076
72366358|NCT02864394|144243374|OTHER||Hazard Ratio (HR)|0.76||||0.0534|TWO_SIDED|95.0|0.54|1.07|||Log Rank|||PFS was not formally tested. Treatment comparison (HR) based on Cox regression model with Efron's method of tie handling with treatment as a covariate. A nominal one-sided p-value for testing was based on log-rank test.||1.07|0.54|0.0534
72366359|NCT02864394|144243375|OTHER||Hazard Ratio (HR)|0.84||||0.0847|TWO_SIDED|95.0|0.66|1.08|||Log Rank|||PFS was not formally tested. Treatment comparison (HR) based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by PD-L1 expression status (TPS ≥50% vs. TPS 1-49%). A nominal one-sided p-value for testing was based on log-rank test stratified by PD-L1 expression status (TPS ≥50% vs. TPS 1-49%).||1.08|0.66|0.0847
72366360|NCT02864394|144243376|OTHER||Difference in Percentage|21.0|||<|0.0001|TWO_SIDED|95.0|11.5|30.7|||Miettinen & Nurminen Method|||ORR was not formally tested. Treatment comparison was based on the Miettinen \& Nurminen method. A nominal one-sided p-value for testing was calculated.||30.7|11.5|<0.0001
72366361|NCT02864394|144243377|OTHER||Difference in Percentage|15.0|||<|0.0001|TWO_SIDED|95.0|8.8|21.6|||Miettinen & Nurminen Method|||ORR was not formally tested. Treatment comparison was based on Miettinen \& Nurminen method stratified by PD-L1 expression status (TPS\>=50% vs. TPS 1-49%). If no participants were in one of the treatment arms involved in a comparison for a particular stratum, then that stratum was excluded from the treatment comparison. A nominal one-sided p-value for testing was calculated.||21.6|8.8|<0.0001
72366362|NCT00918255|144243418|SUPERIORITY_OR_OTHER|||||||0.022||95.0||||When this initial overall comparison of the 3 treatment groups was significant, pairwise comparisons of each adalimumab dose group versus placebo were performed.|Cochran-Mantel-Haenszel|||||||0.022
72366363|NCT00918255|144243418|SUPERIORITY_OR_OTHER|||||||0.025||95.0|||||Cochran-Mantel-Haenszel|Analyzed using CMH test stratified by Hurley Stage.||||||0.025
72366364|NCT00918255|144243418|SUPERIORITY_OR_OTHER|||||||0.252||95.0|||||Cochran-Mantel-Haenszel|Analyzed using CMH test stratified by Hurley Stage.||||||0.252
72366365|NCT00918255|144243419|SUPERIORITY_OR_OTHER|||||||0.062||95.0||||When this initial overall comparison of the 3 treatment groups was significant, pairwise comparisons of each adalimumab dose group versus placebo were performed.|ANCOVA|||||||0.062
72366366|NCT00918255|144243419|SUPERIORITY_OR_OTHER|||||||0.019||95.0|||||ANCOVA|Analyzed using ANCOVA adjusting for Baseline Hurley Stage (I/II vs III).||||||0.019
72366367|NCT00918255|144243419|SUPERIORITY_OR_OTHER|||||||0.286||95.0|||||ANCOVA|Analyzed using ANCOVA adjusting for Baseline Hurley Stage (I/II vs III).||||||0.286
72366368|NCT00918255|144243420|SUPERIORITY_OR_OTHER|||||||1||95.0||||When this initial overall comparison of the 3 treatment groups was significant, pairwise comparisons of each adalimumab dose group versus placebo were performed.|Cochran-Mantel-Haenszel|||||||1.000
72366369|NCT00918255|144243420|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Cochran-Mantel-Haenszel|Analyzed using CMH test stratified by Hurley Stage.||||||1.000
72366370|NCT00918255|144243420|SUPERIORITY_OR_OTHER|||||||0.097||95.0|||||Cochran-Mantel-Haenszel|Analyzed using CMH test stratified by Hurley Stage.||||||0.097
72366371|NCT00918255|144243421|SUPERIORITY_OR_OTHER|||||||0.044||95.0||||When this initial overall comparison of the 3 treatment groups was significant, pairwise comparisons of each adalimumab dose group versus placebo were performed.|Cochran-Mantel-Haenszel|||||||0.044
72366372|NCT00918255|144243421|SUPERIORITY_OR_OTHER|||||||0.051||95.0|||||Cochran-Mantel-Haenszel|Analyzed using CMH test stratified by Hurley Stage.||||||0.051
72366373|NCT00918255|144243421|SUPERIORITY_OR_OTHER|||||||0.32||95.0|||||Cochran-Mantel-Haenszel|Analyzed using CMH test stratified by Hurley Stage.||||||0.320
72366374|NCT00918255|144243422|SUPERIORITY_OR_OTHER|||||||1||95.0||||When this initial overall comparison of the 3 treatment groups was significant, pairwise comparisons of each adalimumab dose group versus placebo were performed.|Cochran-Mantel-Haenszel|||||||1.000
72366375|NCT00918255|144243422|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Cochran-Mantel-Haenszel|Analyzed using CMH test stratified by Hurley Stage.||||||1.000
72366376|NCT00918255|144243422|SUPERIORITY_OR_OTHER|||||||0.673||95.0|||||Cochran-Mantel-Haenszel|Analyzed using CMH test stratified by Hurley Stage.||||||0.673
72366377|NCT00918255|144243423|SUPERIORITY_OR_OTHER|||||||0.012||95.0||||When this initial overall comparison of the 3 treatment groups was significant, pairwise comparisons of each adalimumab dose group versus placebo were performed.|Cochran-Mantel-Haenszel|||||||0.012
72366378|NCT00918255|144243423|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||Cochran-Mantel-Haenszel|Analyzed using CMH test stratified by Hurley Stage.||||||0.020
72366379|NCT00918255|144243423|SUPERIORITY_OR_OTHER|||||||0.721||95.0|||||Cochran-Mantel-Haenszel|Analyzed using CMH test stratified by Hurley Stage.||||||0.721
72366380|NCT00918255|144243424|SUPERIORITY_OR_OTHER|||||||0.045||95.0||||When this initial overall comparison of the 3 treatment groups was significant, pairwise comparisons of each adalimumab dose group versus placebo were performed.|Van Elteren test|||||||0.045
72366381|NCT00918255|144243424|SUPERIORITY_OR_OTHER|||||||0.014||95.0|||||Van Elteren test|Analyzed using Van Elteren test stratified by Hurley Stage.||||||0.014
72366382|NCT00918255|144243424|SUPERIORITY_OR_OTHER|||||||0.169||95.0|||||Van Elteren test|Analyzed using Van Elteren test stratified by Hurley Stage.||||||0.169
72366383|NCT02494323|144243434|SUPERIORITY_OR_OTHER||||||<|0.01||||||P value is adjusted for the comparison of subjects who benefited, were satisfied and willing to continue using the Segmented Electrodes versus subjects who didn't benefit, wern't satisfied ans were not willing to continue using the Segmented Eletrode|t-test, 1 sided|||||||<0.01
72366384|NCT01244893|144243442|NON_INFERIORITY_OR_EQUIVALENCE|This study uses -0.05 LogMAR as the non-inferiority margin.|Mean Difference (Final Values)|0.005|STANDARD_ERROR_OF_MEAN|0.003|||TWO_SIDED|95.0|-0.00092|0.01045|||Mixed Models Analysis||The mean difference is calculated as the test lens - control lens.|"Ho: after time period (6-8 days of lens wear), the test lens - control lens will be greater than or equal to the non-inferiority margin specified .~Ha: after time period, test-control will be less than the margin specified concluding that the test lens will be inferior to control lens in terms of LogMAR scale"||0.01045|-0.00092|
72366385|NCT03408392|144243555|EQUIVALENCE|Bio-equivalence analysis comparing cefixime test and reference product has been presented.|Percentage ratio|105.38|||||TWO_SIDED|90.0|96.11|115.54||||||||115.54|96.11|
72366386|NCT03408392|144243556|EQUIVALENCE|Bio-equivalence analysis comparing cefixime test and reference product has been presented.|Percentage ratio|101.14|||||TWO_SIDED|90.0|93.37|109.55||||||||109.55|93.37|
72366387|NCT03408392|144243557|EQUIVALENCE|Bio-equivalence analysis comparing cefixime test and reference product has been presented.|Percentage ratio|105.14|||||TWO_SIDED|90.0|96.31|114.78||||||||114.78|96.31|
72366388|NCT00885170|144243579|SUPERIORITY_OR_OTHER||Difference in the Least Squares Means|2.67|||<|0.001|TWO_SIDED|95.0|1.17|4.17|||Constrained longitudinal data analysis||Baseline measurement and post-baseline percent changes from baseline, with fixed effects for treatment, time, duration of prior alendronate use (3-5 years, \>5 years), geographic region, machine type (Lunar/Hologic) and treatment-by-time interaction|The primary hypothesis of the study was met if; in postmenopausal women previously treated with alendronate with low BMD, two years of treatment with odanacatib 50 mg significantly increased BMD at the femoral neck site compared to placebo (p-value \< 0.001).||4.17|1.17|<0.001
72366389|NCT00885170|144243580|SUPERIORITY_OR_OTHER||Difference in Percentages vs. Placebo|-5.5|||||TWO_SIDED|95.0|-16.9|6.0|||||Based on Miettinen \& Nurminen method.|||6.0|-16.9|
72366390|NCT00885170|144243581|SUPERIORITY_OR_OTHER||Difference in the Percentage vs. Placebo|5.7|||||TWO_SIDED|95.0|-0.4|12.6|||||Based on Miettinen \& Nurminen method.|||12.6|-0.4|
72366391|NCT00885170|144243582|SUPERIORITY_OR_OTHER||Difference in the least Squares Means|0.88||||0.166|TWO_SIDED|95.0|-0.37|2.14|||Constrained longitudinal data analysis||Baseline measurement and post-baseline percent changes from baseline, with fixed effects for treatment, time, duration of prior alendronate use (3-5 years, \>5 years), geographic region, machine type (Lunar/Hologic) and treatment-by-time interaction|||2.14|-0.37|0.166
72366392|NCT00885170|144243583|SUPERIORITY_OR_OTHER||Difference in the Least Squares Means|3.18||||0.002|TWO_SIDED|95.0|1.19|5.17|||Constrained longitudinal data analysis||Baseline measurement and post-baseline percent changes from baseline, with fixed effects for treatment, time, duration of prior alendronate use (3-5 years, \>5 years), geographic region, machine type (Lunar/Hologic) and treatment-by-time interaction|||5.17|1.19|0.002
72366393|NCT00885170|144243584|SUPERIORITY_OR_OTHER||Difference in the Least Squares Means|1.0||||0.142|TWO_SIDED|95.0|-0.34|2.35|||Constrained longitudinal data analysis||Baseline measurement and post-baseline percent changes from baseline, with fixed effects for treatment, time, duration of prior alendronate use (3-5 years, \>5 years), geographic region, machine type (Lunar/Hologic) and treatment-by-time interaction|||2.35|-0.34|0.142
72366394|NCT00885170|144243585|SUPERIORITY_OR_OTHER||Difference in the Least Squares Means|2.7|||<|0.001|TWO_SIDED|95.0|1.41|4.0|||cLDA||Baseline measurement and post-baseline percent changes from baseline, with fixed effects for treatment, time, duration of prior alendronate use (3-5 years, \>5 years), geographic region, machine type (Lunar/Hologic) and treatment-by-time interaction|||4.00|1.41|<0.001
72366395|NCT00885170|144243586|SUPERIORITY_OR_OTHER||Difference in the Least Squares Means|1.06||||0.023|TWO_SIDED|95.0|0.15|1.98|||cLDA||Baseline measurement and post-baseline percent changes from baseline, with fixed effects for treatment, time, duration of prior alendronate use (3-5 years, \>5 years), geographic region, machine type (Lunar/Hologic) and treatment-by-time interaction|||1.98|0.15|0.023
72366396|NCT00885170|144243587|SUPERIORITY_OR_OTHER||Difference in the Least Squares Means|2.57|||<|0.001|TWO_SIDED|95.0|1.26|3.89|||cLDA||Baseline measurement and post-baseline percent changes from baseline, with fixed effects for treatment, time, duration of prior alendronate use (3-5 years, \>5 years), geographic region, machine type (Lunar/Hologic) and treatment-by-time interaction|||3.89|1.26|<0.001
72366397|NCT00885170|144243588|SUPERIORITY_OR_OTHER||Difference in the Least Squares Means|0.8||||0.103|TWO_SIDED|95.0|-0.16|1.77|||cLDA||Baseline measurement and post-baseline percent changes from baseline, with fixed effects for treatment, time, duration of prior alendronate use (3-5 years, \>5 years), geographic region, machine type (Lunar/Hologic) and treatment-by-time interaction|||1.77|-0.16|0.103
72366398|NCT00885170|144243589|SUPERIORITY_OR_OTHER||Difference in the Least Squares Means|0.22||||0.763|TWO_SIDED|95.0|-1.23|1.67|||cLDA||Baseline measurement and post-baseline percent changes from baseline, with fixed effects for treatment, time, duration of prior alendronate use (3-5 years, \>5 years), geographic region, machine type (Lunar/Hologic) and treatment-by-time interaction|||1.67|-1.23|0.763
72366399|NCT00885170|144243590|SUPERIORITY_OR_OTHER||Difference in the Least Squares Means|0.38||||0.578|TWO_SIDED|95.0|-0.96|1.72|||cLDA||Baseline measurement and post-baseline percent changes from baseline, with fixed effects for treatment, time, duration of prior alendronate use (3-5 years, \>5 years), geographic region, machine type (Lunar/Hologic) and treatment-by-time interaction|||1.72|-0.96|0.578
72366400|NCT00885170|144243591|SUPERIORITY_OR_OTHER||Difference in the Least Squares Means|10.16||||0.5|TWO_SIDED|95.0|-19.39|39.72|||cLDA||Log-transformed baseline and post-baseline measurements up to Month 24, with fixed effects for treatment, time, duration of prior alendronate use, geographical region, the interaction of time-by-treatment and the time-by-factor interactions.|||39.72|-19.39|0.500
72366401|NCT00885170|144243592|SUPERIORITY_OR_OTHER||Difference in the Least Squares Means|-5.82||||0.709|TWO_SIDED|95.0|-36.29|24.65|||cLDA||Log-transformed baseline and post-baseline measurements up to Month 24, with fixed effects for treatment, time, duration of prior alendronate use, geographical region, the interaction of time-by-treatment and the time-by-factor interactions.|||24.65|-36.29|0.709
72366402|NCT00885170|144243593|SUPERIORITY_OR_OTHER||Difference in the Least Squares Means|-47.04|||<|0.001|TWO_SIDED|95.0|-62.4|-31.67|||cLDA||Log-transformed baseline and post-baseline measurements up to Month 24, with fixed effects for treatment, time, duration of prior alendronate use, geographical region, the interaction of time-by-treatment and the time-by-factor interactions.|||-31.67|-62.40|<0.001
72366403|NCT00885170|144243594|SUPERIORITY_OR_OTHER||Difference in the Least Squares Means|-46.29|||<|0.001|TWO_SIDED|95.0|-61.43|-31.15|||cLDA||Log-transformed baseline and post-baseline measurements up to Month 24, with fixed effects for treatment, time, duration of prior alendronate use, geographical region, the interaction of time-by-treatment and the time-by-factor interactions.|||-31.15|-61.43|<0.001
72366404|NCT00885170|144243595|SUPERIORITY_OR_OTHER||Difference in the Least Squares Means|10.96||||0.186|TWO_SIDED|95.0|-5.29|27.22|||cLDA||Log-transformed baseline and post-baseline measurements up to Month 24, with fixed effects for treatment, time, duration of prior alendronate use, geographical region, the interaction of time-by-treatment and the time-by-factor interactions.|||27.22|-5.29|0.186
72366405|NCT00885170|144243596|SUPERIORITY_OR_OTHER||Difference in the Least Squares Means|12.82||||0.015|TWO_SIDED|95.0|2.54|23.1|||cLDA||Log-transformed baseline and post-baseline measurements up to Month 24, with fixed effects for treatment, time, duration of prior alendronate use, geographical region, the interaction of time-by-treatment and the time-by-factor interactions.|||23.10|2.54|0.015
72366406|NCT00885170|144243597|SUPERIORITY_OR_OTHER||Difference in the Least Squares Means|31.17||||0.011|TWO_SIDED|95.0|7.13|55.21|||cLDA||Log-transformed baseline and post-baseline measurements up to Month 24, with fixed effects for treatment, time, duration of prior alendronate use, geographical region, the interaction of time-by-treatment and the time-by-factor interactions.|||55.21|7.13|0.011
72431779|NCT01323660|144375439|SUPERIORITY_OR_OTHER||Least squares mean difference|0.15|||<|0.001|TWO_SIDED|95.0|0.098|0.201|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least square mean change difference=UMEC/VI 125/25 µg minus VI 25 µg.|||0.201|0.098|<0.001
72366407|NCT00885170|144243598|SUPERIORITY_OR_OTHER||Difference in the Least Squares Means|24.01||||0.059|TWO_SIDED|95.0|-0.93|48.94|||cLDA||Log-transformed baseline and post-baseline measurements up to Month 24, with fixed effects for treatment, time, duration of prior alendronate use, geographical region, the interaction of time-by-treatment and the time-by-factor interactions.|||48.94|-0.93|0.059
72366408|NCT00885170|144243599|SUPERIORITY_OR_OTHER||Difference in the Least Squares Means|0.11||||0.846|TWO_SIDED|95.0|-0.95|1.16|||cLDA||Log-transformed baseline and post-baseline measurements up to Month 24, with fixed effects for treatment, time, duration of prior alendronate use, geographical region, the interaction of time-by-treatment and the time-by-factor interactions.|||1.16|-0.95|0.846
72366409|NCT00885170|144243600|SUPERIORITY_OR_OTHER||Difference in the Least Squares Means|1.38||||0.413|TWO_SIDED|95.0|-1.91|4.67|||cLDA||Log-transformed baseline and post-baseline measurements up to Month 24, with fixed effects for treatment, time, duration of prior alendronate use, geographical region, the interaction of time-by-treatment and the time-by-factor interactions.|||4.67|-1.91|0.413
72366410|NCT00885170|144243601|SUPERIORITY_OR_OTHER||Difference in the Least Squares Means|-5.91||||0.326|TWO_SIDED|95.0|-17.66|5.85|||cLDA||Log-transformed baseline and post-baseline measurements up to Month 24, with fixed effects for treatment, time, duration of prior alendronate use, geographical region, the interaction of time-by-treatment and the time-by-factor interactions.|||5.85|-17.66|0.326
72366411|NCT00885170|144243602|SUPERIORITY_OR_OTHER||Difference in the Least Squares Means|1.47||||0.835|TWO_SIDED|95.0|-12.37|15.32|||cLDA||Log-transformed baseline and post-baseline measurements up to Month 24, with fixed effects for treatment, time, duration of prior alendronate use, geographical region, the interaction of time-by-treatment and the time-by-factor interactions.|||15.32|-12.37|0.835
72366412|NCT00885170|144243603|SUPERIORITY_OR_OTHER||Difference in the Least Squares Means|-3.13||||0.376|TWO_SIDED|95.0|-10.04|3.78|||cLDA||Log-transformed baseline and post-baseline measurements up to Month 24, with fixed effects for treatment, time, duration of prior alendronate use, geographical region, the interaction of time-by-treatment and the time-by-factor interactions.|||3.78|-10.04|0.376
72366413|NCT03771664|144243604|SUPERIORITY||Least Square (LS) Mean Difference|3.2|STANDARD_ERROR_OF_MEAN|2.23||0.1537|TWO_SIDED|95.0|-1.2|7.7||Average change from baseline in SE was analyzed by analysis of covariance (ANCOVA) with explanatory (treatment, baseline antidepressant use, baseline SE) and response variables \[change from baseline in sleep efficiency at Day 14 (EODBT)\].|ANCOVA|||||7.7|-1.2|0.1537
72366414|NCT03771664|144243605|SUPERIORITY||LS Mean Difference|-13.0|STANDARD_ERROR_OF_MEAN|8.07||0.1126|TWO_SIDED|95.0|-29.0|3.1||Change from BL in overall WASO was analyzed by ANCOVA with explanatory variables: Treatment, BL antidepressant use, BL PSG-derived sleep variables score; Response variable: Change from BL in PSG-derived sleep variables at Day 14 (EODBT).|ANCOVA|||Change from baseline (BL) in overall WASO||3.1|-29.0|0.1126
72366415|NCT03771664|144243605|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|1.63||0.9819|TWO_SIDED|95.0|-3.3|3.2||Change from BL in WASO was analyzed by ANCOVA with explanatory variables: Treatment, BL antidepressant use, BL PSG-derived sleep variables score; Response variable: Change from BL in PSG-derived sleep variables at Day 14 (EODBT).|ANCOVA|||Change from BL in WASO in quarter 1||3.2|-3.3|0.9819
72366416|NCT03771664|144243605|SUPERIORITY||LS Mean Difference|-4.3|STANDARD_ERROR_OF_MEAN|3.19||0.1838|TWO_SIDED|95.0|-10.6|2.1||Change from BL in WASO was analyzed by ANCOVA with explanatory variables: Treatment, BL antidepressant use, BL PSG-derived sleep variables score; Response variable: Change from BL in PSG-derived sleep variables at Day 14 (EODBT).|ANCOVA|||Change from BL in WASO in quarter 2||2.1|-10.6|0.1838
72366417|NCT03771664|144243605|SUPERIORITY||LS Mean Difference|-7.1|STANDARD_ERROR_OF_MEAN|3.97||0.0797|TWO_SIDED|95.0|-15.0|0.9||Change from BL in WASO was analyzed by ANCOVA with explanatory variables: Treatment, BL antidepressant use, baseline PSG-derived sleep variables score; Response variable: Change from BL in PSG-derived sleep variables at Day 14 (EODBT).|ANCOVA|||Change from BL in WASO in quarter 3||0.9|-15.0|0.0797
72366418|NCT03771664|144243605|SUPERIORITY||LS Mean Difference|-6.1|STANDARD_ERROR_OF_MEAN|4.24||0.1559|TWO_SIDED|95.0|-14.5|2.4||Change from BL in WASO was analyzed by ANCOVA with explanatory variables: Treatment, BL antidepressant use, baseline PSG-derived sleep variables score; Response variable: Change from BL in PSG-derived sleep variables at Day 14 (EODBT).|ANCOVA|||Change from BL in WASO in quarter 4||2.4|-14.5|0.1559
72366419|NCT03771664|144243606|SUPERIORITY||LS Mean Difference|15.8|STANDARD_ERROR_OF_MEAN|10.67||0.1441|TWO_SIDED|95.0|-5.5|37.0||Change from BL in TST was analyzed by ANCOVA with explanatory variables: Treatment, BL antidepressant use, BL PSG-derived sleep variables score; Response variable: Change from BL in PSG-derived sleep variables at Day 14 (EODBT).|ANCOVA|||Change from BL in overall TST||37.0|-5.5|0.1441
72366420|NCT03771664|144243606|SUPERIORITY||LS Mean Difference|4.7|STANDARD_ERROR_OF_MEAN|5.47||0.3951|TWO_SIDED|95.0|-6.2|15.6||Change from BL in TST was analyzed by ANCOVA with explanatory variables: Treatment, BL antidepressant use, BL PSG-derived sleep variables score; Response variable: Change from BL in PSG-derived sleep variables at Day 14 (EODBT).|ANCOVA|||Change from BL in TST in quarter 1||15.6|-6.2|0.3951
72366421|NCT03771664|144243606|SUPERIORITY||LS Mean Difference|3.7|STANDARD_ERROR_OF_MEAN|4.16||0.3705|TWO_SIDED|95.0|-4.5|12.0||Change from BL in TST was analyzed by ANCOVA with explanatory variables: Treatment, BL antidepressant use, BLPSG-derived sleep variables score; Response variable: Change from BL in PSG-derived sleep variables at Day 14 (EODBT).|ANCOVA|||Change from BL in TST in quarter 2||12.0|-4.5|0.3705
72366422|NCT03771664|144243606|SUPERIORITY||LS Mean Difference|6.0|STANDARD_ERROR_OF_MEAN|4.04||0.1412|TWO_SIDED|95.0|-2.0|14.0||Change from BL in TST was analyzed by ANCOVA with explanatory variables: Treatment, BL antidepressant use, BL PSG-derived sleep variables score; Response variable: Change from BL in PSG-derived sleep variables at Day 14 (EODBT).|ANCOVA|||Change from BL in TST in quarter 3||14.0|-2.0|0.1412
72431780|NCT01323660|144375439|SUPERIORITY_OR_OTHER||Least squares mean difference|0.243|||<|0.001|TWO_SIDED|95.0|0.202|0.284|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least square mean change difference=UMEC/VI 62.5/25 µg minus Placebo.|||0.284|0.202|<0.001
72431781|NCT01323660|144375439|SUPERIORITY_OR_OTHER||Least squares mean difference|0.261|||<|0.001|TWO_SIDED|95.0|0.22|0.303|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least square mean change difference=UMEC/VI 125/25 µg minus Placebo.|||0.303|0.220|<0.001
72366423|NCT03771664|144243606|SUPERIORITY||LS Mean Difference|6.5|STANDARD_ERROR_OF_MEAN|4.24||0.1298|TWO_SIDED|95.0|-2.0|15.0||Change from BL in TST was analyzed by ANCOVA with explanatory variables: Treatment, BL antidepressant use, BL PSG-derived sleep variables score; Response variable: Change from BL in PSG-derived sleep variables at Day 14 (EODBT).|ANCOVA|||Change from BL in TST in quarter 4||15.0|-2.0|0.1298
72366424|NCT03771664|144243607|SUPERIORITY||LS Mean Difference|-2.5|STANDARD_ERROR_OF_MEAN|7.87||0.7526|TWO_SIDED|95.0|-18.2|13.2||Change from BL in LPS was analyzed by ANCOVA with explanatory variables: Treatment, BL antidepressant use, BL PSG-derived sleep variables score; Response variable: Change from BL in PSG-derived sleep variables at Day 14 (EODBT).|ANCOVA|||||13.2|-18.2|0.7526
72366425|NCT03771664|144243608|SUPERIORITY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.83||0.6769|TWO_SIDED|95.0|-2.0|1.3||Change from BL in NAW was analyzed by ANCOVA with explanatory variables: Treatment, BL antidepressant use, BL PSG-derived sleep variables score; Response variable: Change from BL in PSG-derived sleep variables at Day 14 (EODBT).|ANCOVA|||||1.3|-2.0|0.6769
72366426|NCT03771664|144243609|SUPERIORITY||LS Mean Difference|-3.0|STANDARD_ERROR_OF_MEAN|1.7||0.0824|TWO_SIDED|95.0|-6.4|0.4||Change from BL in MDA was analyzed by ANCOVA with explanatory variables: Treatment, BL antidepressant use, BL PSG-derived sleep variables score; Response variable: Change from BL in PSG-derived sleep variables at Day 14 (EODBT).|ANCOVA|||Change from BL in mean duration of awakenings (MDA) in total||0.4|-6.4|0.0824
72366427|NCT03771664|144243609|SUPERIORITY||LS Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|1.07||0.4269|TWO_SIDED|95.0|-3.0|1.3||Change from BL in MDA was analyzed by ANCOVA with explanatory variables: Treatment, BL antidepressant use, BL PSG-derived sleep variables score; Response variable: Change from BL in PSG-derived sleep variables at Day 14 (EODBT).|ANCOVA|||Change from BL in MDA in quarter 1||1.3|-3.0|0.4269
72366428|NCT03771664|144243609|SUPERIORITY|Change from BL in MDA was analyzed by ANCOVA with explanatory variables: Treatment, BL antidepressant use, BL PSG-derived sleep variables score; Response variable: Change from BL in PSG-derived sleep variables at Day 14 (EODBT).|LS Mean Difference|-3.5|STANDARD_ERROR_OF_MEAN|3.02||0.2482|TWO_SIDED|95.0|-9.5|2.5|||ANCOVA|||Change from BL in MDA in quarter 2||2.5|-9.5|0.2482
72366429|NCT03771664|144243609|SUPERIORITY||LS Mean Difference|-3.4|STANDARD_ERROR_OF_MEAN|3.34||0.3076|TWO_SIDED|95.0|-10.1|3.2||Change from BL in MDA was analyzed by ANCOVA with explanatory variables: Treatment, BL antidepressant use, BL PSG-derived sleep variables score; Response variable: Change from BL in PSG-derived sleep variables at Day 14 (EODBT).|ANCOVA|||Change from BL in MDA in quarter 3||3.2|-10.1|0.3076
72366430|NCT03771664|144243609|SUPERIORITY||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.68||0.4491|TWO_SIDED|95.0|-1.9|0.8||Change from BL in MDA was analyzed by ANCOVA with explanatory variables: Treatment, BL antidepressant use, BL PSG-derived sleep variables score; Response variable: Change from BL in PSG-derived sleep variables at Day 14 (EODBT).|ANCOVA|||Change from BL in MDA in quarter 4||0.8|-1.9|0.4491
72366431|NCT03771664|144243610|SUPERIORITY||LS Mean Difference|0.4|STANDARD_ERROR_OF_MEAN|2.47||0.8724|TWO_SIDED|95.0|-4.5|5.3||Change from BL in DS N1 sleep was analyzed by ANCOVA with explanatory variables: Treatment, BL antidepressant use, BL PSG-derived sleep variables score; Response variable: Change from BL in PSG-derived sleep variables at Day 14 (EODBT).|ANCOVA|||Change from BL in duration of stage (DS) N1 sleep||5.3|-4.5|0.8724
72366432|NCT03771664|144243610|SUPERIORITY||LS Mean Difference|18.6|STANDARD_ERROR_OF_MEAN|8.08||0.0238|TWO_SIDED|95.0|2.5|34.7||Change from BL in DS N2 sleep was analyzed by ANCOVA with explanatory variables: Treatment, BL antidepressant use, BL PSG-derived sleep variables score; Response variable: Change from BL in PSG-derived sleep variables at Day 14 (EODBT).|ANCOVA|||Change from BL in DS N2 sleep||34.7|2.5|0.0238
72366433|NCT03771664|144243610|SUPERIORITY||LS Mean Difference|4.9|STANDARD_ERROR_OF_MEAN|5.62||0.3863|TWO_SIDED|95.0|-6.3|16.1||Change from BL in DS N3 sleep was analyzed by ANCOVA with explanatory variables: Treatment, BL antidepressant use, BL PSG-derived sleep variables score; Response variable: Change from BL in PSG-derived sleep variables at Day 14 (EODBT).|ANCOVA|||Change from BL in DS N3 sleep||16.1|-6.3|0.3863
72366434|NCT03771664|144243610|SUPERIORITY||LS Mean Difference|-10.2|STANDARD_ERROR_OF_MEAN|4.69||0.032|TWO_SIDED|95.0|-19.6|-0.9||Change from BL in REM sleep duration was analyzed by ANCOVA with explanatory (Treatment, BL antidepressant use, BL PSG-derived sleep variables score) and response variables \[Change from BL in PSG-derived sleep variables at Day 14(EODBT)\].|ANCOVA|||Change from BL in duration of REM sleep||-0.9|-19.6|0.0320
72366435|NCT03771664|144243611|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.8||0.9524|TWO_SIDED|95.0|-1.7|1.6||Change from BL in PS N1 sleep time was analyzed by ANCOVA with explanatory variables: Treatment, BL antidepressant use, BL PSG-derived sleep variables score;Response variable: Change from BL in PSG-derived sleep variables at Day 14 (EODBT).|ANCOVA|||Change from BL in percentage of stage (PS) N1 sleep time||1.6|-1.7|0.9524
72366436|NCT03771664|144243611|SUPERIORITY||LS Mean Difference|2.6|STANDARD_ERROR_OF_MEAN|1.55||0.093|TWO_SIDED|95.0|-0.5|5.7||Change from BL in PS N2 sleep time was analyzed by ANCOVA with explanatory variables: Treatment, BL antidepressant use, BL PSG-derived sleep variables score; Response variable: Change from BL in PSG-derived sleep variables at Day 14 (EODBT).|ANCOVA|||Change from BL in PS N2 sleep time||5.7|-0.5|0.0930
72366437|NCT03771664|144243611|SUPERIORITY||LS Mean Difference|1.2|STANDARD_ERROR_OF_MEAN|1.52||0.4427|TWO_SIDED|95.0|-1.9|4.2||Change from BL in PS N3 sleep time was analyzed by ANCOVA with explanatory variables: Treatment, BL antidepressant use, BL PSG-derived sleep variables score; Response variable: Change from BL in PSG-derived sleep variables at Day 14 (EODBT).|ANCOVA|||Change from BL in PS N3 sleep time||4.2|-1.9|0.4427
72366438|NCT03771664|144243611|SUPERIORITY||LS Mean Difference|-3.8|STANDARD_ERROR_OF_MEAN|1.06||0.0006|TWO_SIDED|95.0|-5.9|-1.7||Change from BL in % of REM sleep duration was analyzed by ANCOVA with explanatory (Treatment, BL antidepressant use, BL PSG-derived sleep variables score) and response variables \[Change from BL in PSG-derived sleep variables at Day 14 (EODBT)\].|ANCOVA|||Change from BL in percentage (%) of REM sleep time||-1.7|-5.9|0.0006
72366439|NCT03771664|144243612|SUPERIORITY||LS Mean Difference|33.7|STANDARD_ERROR_OF_MEAN|12.42||0.0083|TWO_SIDED|95.0|8.9|58.4||Change from BL in latency to first REM period was analyzed by ANCOVA with explanatory (Treatment, BL antidepressant use, BL PSG-derived sleep variables score) and response variables \[Change from BL in PSG-derived sleep variables at Day 14 (EODBT)\].|ANCOVA|||Change from BL in latency to the first REM period||58.4|8.9|0.0083
72366440|NCT03771664|144243612|SUPERIORITY||LS Mean Difference|43.2|STANDARD_ERROR_OF_MEAN|10.95||0.0002|TWO_SIDED|95.0|21.3|65.0||Change from BL in latency to second REM period was analyzed by ANCOVA with explanatory (Treatment, BL antidepressant use, BL PSG-derived sleep variables score) and response variables \[Change from BL in PSG-derived sleep variables at Day 14 (EODBT)\].|ANCOVA|||Change from BL in latency to the second REM period||65.0|21.3|0.0002
72366441|NCT03771664|144243612|SUPERIORITY||LS Mean Difference|38.2|STANDARD_ERROR_OF_MEAN|10.99||0.0009|TWO_SIDED|95.0|16.2|60.2||Change from BL in latency to third REM period was analyzed by ANCOVA with explanatory (Treatment, BL antidepressant use, BL PSG-derived sleep variables score) and response variables \[Change from BL in PSG-derived sleep variables at Day 14 (EODBT)\].|ANCOVA|||Change from BL in latency to the third REM period||60.2|16.2|0.0009
72366442|NCT03771664|144243612|SUPERIORITY||LS Mean Difference|26.0|STANDARD_ERROR_OF_MEAN|14.84||0.0899|TWO_SIDED|95.0|-4.3|56.3||Change from BL in latency to fourth REM period was analyzed by ANCOVA with explanatory (Treatment, BL antidepressant use, BL PSG-derived sleep variables score) and response variables \[Change from BL in PSG-derived sleep variables at Day 14 (EODBT)\].|ANCOVA|||Change from BL in latency to the fourth REM period||56.3|-4.3|0.0899
72366443|NCT03771664|144243613|SUPERIORITY||LS Mean Difference|-171.1|STANDARD_ERROR_OF_MEAN|46.06||0.0004|TWO_SIDED|95.0|-262.9|-79.4||Change from BL in REM density was analyzed by ANCOVA with explanatory (Treatment, BL antidepressant use, BL PSG-derived sleep variables score) and response variables \[Change from BL in PSG-derived sleep variables at Day 14 (EODBT)\].|ANCOVA|||||-79.4|-262.9|0.0004
72366444|NCT03771664|144243614|SUPERIORITY||LS Mean Difference|-288.0|STANDARD_ERROR_OF_MEAN|68.81|<|0.0001|TWO_SIDED|95.0|-425.1|-151.0||Change from BL in REMA was analyzed by ANCOVA with explanatory (Treatment, BL antidepressant use, baseline PSG-derived sleep variables score) and response variables \[Change from BL in PSG-derived sleep variables at Day 14 (EODBT)\].|ANCOVA|||||-151.0|-425.1|<0.0001
72366445|NCT03771664|144243616|SUPERIORITY||LS Mean Difference|10.4|STANDARD_ERROR_OF_MEAN|14.65||0.4814|TWO_SIDED|95.0|-18.8|39.5||Change from BL in sTST was analyzed by Mixed Model Repeated Measures (MMRM) with treatment baseline antidepressant use, baseline CSD-C value, assessment time point, and time point-by-treatment interaction as fixed effects.|MMRM|||Change from BL in sTST||39.5|-18.8|0.4814
72366446|NCT03771664|144243616|SUPERIORITY||LS Mean Difference|-10.9|STANDARD_ERROR_OF_MEAN|6.45||0.0964|TWO_SIDED|95.0|-23.7|2.0||Change from BL in sWASO was analyzed by MMRM with treatment baseline antidepressant use, baseline CSD-C value, assessment time point, and time point-by-treatment interaction as fixed effects.|MMRM|||Change from BL in sWASO||2.0|-23.7|0.0964
72366447|NCT03771664|144243616|SUPERIORITY||LS Mean Difference|6.6|STANDARD_ERROR_OF_MEAN|7.32||0.3672|TWO_SIDED|95.0|-7.9|21.2||Change from BL in sSL was analyzed by MMRM with treatment baseline antidepressant use, baseline CSD-C value, assessment time point, and time point-by-treatment interaction as fixed effects.|MMRM|||Change from BL in sSL||21.2|-7.9|0.3672
72366448|NCT00561925|144243628|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority of nevirapine XR to nevirapine IR was established if the lower bound of the confidence interval was greater than -10%|Cochran's statistic|4.9|||<|0.0001||95.0|-0.1|10.0|||Cochran's statistic||Weighted treatment difference and corresponding variance were calculated based on Cochran's statistic.|||10.0|-0.1|<0.0001
72366449|NCT00561925|144243630|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority of nevirapine XR to nevirapine IR was established if the lower bound of the confidence interval was greater than -2%|Cochran's statistic|4.84|||<|0.0001||95.0|-1.11|10.79|||Cochran's statistic||Weighted treatment difference and corresponding variance were calculated based on Cochran's statistic.|||10.79|-1.11|<0.0001
72366450|NCT00561925|144243632|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01||||0.7719||95.0|-0.08|0.06|||ANCOVA|Means adjusted for baseline HIV-1 viral load stratum||||0.06|-0.08|0.7719
72366451|NCT00561925|144243633|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|32.87||||0.0078||95.0|8.67|57.06|||ANCOVA|Means adjusted for baseline HIV-1 viral load stratum||||57.06|8.67|0.0078
72366452|NCT00561925|144243641|NON_INFERIORITY_OR_EQUIVALENCE|equivalence test with 80% -125% boundaries|adjusted gMean|79.58|STANDARD_ERROR_OF_MEAN|1.04||0.5542||90.0|74.62|84.86||p-value for ratio outside the interval 80%-125%|ANOVA||Inter-individual gCV = 49.9|adjusted geometric mean ratio NVP XR : NVP IR||84.86|74.62|0.5542
72366453|NCT05021978|144243647|OTHER|||||||0.1048||||||Change from baseline to Day 7 in TETRAS Upper Limb Score|Mixed Models Analysis|Includes timepoint as fixed effect and baseline TETRAS score as a covariate. Within subject variability modeled using unstructured covariance pattern.||Sample size is a convenience sample determined according to feasibility to provide sufficient and safety data to inform the development of future controlled studies with PRAX-944. In the open-label phase of the trial (Part A ), at least 10 participants would provide an 80% probability of observing at least 1 AE with an underlying incidence of 15% or greater and provide approximately 80% power to detect an effect size of 1.0 on the primary endpoint change from baseline in TETRAS Upper Limb score.||||0.1048
72366454|NCT05021978|144243647|OTHER|||||||0.0028||||||Change from baseline to Day 14 in TETRAS UL score|Mixed Models Analysis|||||||0.0028
72366455|NCT05021978|144243651|OTHER|||||||0.4025|||||||Mixed Models Analysis|Change from baseline to Day 7||||||0.4025
72366456|NCT05021978|144243651|OTHER|||||||0.0766||||||Change from baseline to Day 14|Mixed Models Analysis|||||||0.0766
72366457|NCT05021978|144243652|OTHER|||||||0.2501||||||Change from baseline to Day 7|Mixed Models Analysis|||||||0.2501
72366458|NCT05021978|144243652|OTHER|||||||0.1874||||||Chnage from baseline to Day 14|Mixed Models Analysis|||||||0.1874
72366459|NCT05021978|144243653|OTHER|||||||0.4722||||||Item 6 Archimedes Spiral (right) change from baseline to Day 7|Mixed Models Analysis|||||||0.4722
72366460|NCT05021978|144243653|OTHER|||||||0.6215||||||Item 6 Archimedes Spiral (left) change from baseline to Day 7|Mixed Models Analysis|||||||0.6215
72366461|NCT05021978|144243653|OTHER|||||||0.9648||||||Item 7 Handwriting change from baseline to Day 7|Mixed Models Analysis|||||||0.9648
72366462|NCT05021978|144243653|OTHER|||||||0.2855||||||Item 7 Handwriting change from baseline to Day 14|Mixed Models Analysis|||||||0.2855
72366463|NCT05021978|144243653|OTHER|||||||0.205||||||Item 6 Archimedes Spiral (right) change from baseline to Day 14|Mixed Models Analysis|||||||0.2050
72366464|NCT05021978|144243653|OTHER|||||||0.2364||||||Item 6 Archimedes Spiral (left) change from baseline to Day 14|Mixed Models Analysis|||||||0.2364
72366465|NCT05021978|144243657|OTHER|||||||0.0216|||||||Mixed Models Analysis|||||||0.0216
72366466|NCT05021978|144243658|OTHER|||||||0.1042||||||Change from baseline Day 7|Mixed Models Analysis|||||||0.1042
72366467|NCT05021978|144243658|OTHER|||||||0.0257||||||Change from baseline Day 21|Mixed Models Analysis|||||||0.0257
72366468|NCT05021978|144243659|OTHER|||||||0.2971||||||Change from baseline to Day 7|Mixed Models Analysis|||||||0.2971
72366469|NCT05021978|144243659|OTHER|||||||0.2034||||||Change from baseline Day 21|Mixed Models Analysis|||||||0.2034
72366470|NCT05021978|144243659|OTHER|||||||0.1105||||||Change from baseline to Day 42|Mixed Models Analysis|||||||0.1105
72366471|NCT05021978|144243660|OTHER|||||||0.005||||||Change from baseline to Day 7|Mixed Models Analysis|||||||0.0050
72366472|NCT05021978|144243660|OTHER|||||||0.0018||||||Change from baseline to Day 21|Mixed Models Analysis|||||||0.0018
72366473|NCT05021978|144243660|OTHER|||||||0.0061||||||Change from baseline to Day 42|Mixed Models Analysis|||||||0.0061
72366474|NCT05021978|144243661|OTHER|||||||0.9776||||||Item 6 Archimedes Spiral (right) change from baseline to Day 7|Mixed Models Analysis|||||||0.9776
72366475|NCT05021978|144243661|OTHER|||||||0.1962||||||Item 6 Archimedes Spiral (left) change from baseline to Day 7|Mixed Models Analysis|||||||0.1962
72366476|NCT05021978|144243661|OTHER|||||||0.9419||||||Item 7 Handwriting change from baseline to Day 7|Mixed Models Analysis|||||||0.9419
72366477|NCT05021978|144243661|OTHER|||||||0.0668||||||Item 6 Archimedes Spiral (right) change from baseline to Day 21|Mixed Models Analysis|||||||0.0668
72366478|NCT05021978|144243661|OTHER|||||||0.9191||||||Item 6 Archimedes Spiral (left) change from baseline to Day 21|Mixed Models Analysis|||||||0.9191
72366479|NCT05021978|144243661|OTHER|||||||0.6075||||||Item 7 Handwriting change from baseline to Day 21|Mixed Models Analysis|||||||0.6075
72366480|NCT05021978|144243661|OTHER|||||||0.246||||||Item 6 Archimedes Spiral (right) change from baseline to Day 42|Mixed Models Analysis|||||||0.2460
72366481|NCT05021978|144243661|OTHER|||||||0.6736||||||Item 6 Archimedes Spiral (left) change from baseline to Day 42|Mixed Models Analysis|||||||0.6736
72366482|NCT05021978|144243661|OTHER|||||||0.8511||||||Item 7 Handwriting change from baseline to Day 42|Mixed Models Analysis|||||||0.8511
72366483|NCT05021978|144243662|OTHER|||||||0.1505||||||Change from baseline to Day 7|Mixed Models Analysis|||||||0.1505
72366484|NCT05021978|144243662|OTHER|||||||0.0543||||||Change from baseline to Day 21|Mixed Models Analysis|||||||0.0543
72366485|NCT05021978|144243662|OTHER|||||||0.0015||||||Change from baseline to Day 42|Mixed Models Analysis|||||||0.0015
72366486|NCT05021978|144243663|OTHER|||||||0.8638||||||Change from baseline to Day 7|Mixed Models Analysis|||||||0.8638
72366487|NCT05021978|144243663|OTHER|||||||0.0605||||||Change from baseline to Day 21|Mixed Models Analysis|||||||0.0605
72366488|NCT05021978|144243663|OTHER|||||||0.0871||||||Change from baseline to Day 42|Mixed Models Analysis|||||||0.0871
72366489|NCT02177032|144243665|NON_INFERIORITY_OR_EQUIVALENCE|"The non-inferiority in immune response of the 4-sites, 1-week (4-4-4-0-0) ID PEP regimen compared to the currently recommended 2-sites TRC (2-2-2-0-2) ID PEP regimen, with or without HRIG, will be established If the lower bound of the two sided 95% confidence interval around the differences of the percentage of subject with RVNA titer ≥ 0.5 IU/ml at day 50 is \> -0.05 (non-inferiority margin)."|Protection Rate Differences|-1.0|||||TWO_SIDED|95.0|-2.4|0.0|||Fisher Exact|||||0|-2.4|
72366490|NCT02177032|144243666|NON_INFERIORITY_OR_EQUIVALENCE|"The investigational regimen 4-sites, 1-week ID PEP will be declared as non-inferior to currently recommended 2-sites TRC ID PEP regimen if the lower bound of the two sided 95% confidence interval around of the observed GMC ratio is greater than 0.667."|Vaccine Group Ratios|0.46|||||TWO_SIDED|95.0|0.37|0.58|||ANOVA|||||0.58|0.37|
72366491|NCT02177032|144243667|NON_INFERIORITY_OR_EQUIVALENCE|"The investigational regimen 4-sites, 1-week ID PEP will be declared as non-inferior to currently recommended 2-sites TRC ID PEP regimen if the lower bound of the two sided 95% confidence interval around of the observed GMC ratio is greater than 0.667 (Day 8)"|Vaccine Group Ratios|1.04|||||TWO_SIDED|95.0|0.84|1.29|||ANOVA|||||1.29|0.84|
72366492|NCT02177032|144243667|NON_INFERIORITY_OR_EQUIVALENCE|"The investigational regimen 4-sites, 1-week ID PEP will be declared as non-inferior to currently recommended 2-sites TRC ID PEP regimen if the lower bound of the two sided 95% confidence interval around of the observed GMC ratio is greater than 0.667 (Day 15)"|Vaccine Group Ratios|1.68|||||TWO_SIDED|95.0|1.35|2.1|||ANOVA|||||2.1|1.35|
72366493|NCT02177032|144243667|NON_INFERIORITY_OR_EQUIVALENCE|"The investigational regimen 4-sites, 1-week ID PEP will be declared as non-inferior to currently recommended 2-sites TRC ID PEP regimen if the lower bound of the two sided 95% confidence interval around of the observed GMC ratio is greater than 0.667 (Day 91)."|Vaccine Group Ratios|0.68|||||TWO_SIDED|95.0|0.54|0.85|||ANOVA|||||0.85|0.54|
72366494|NCT02177032|144243667|NON_INFERIORITY_OR_EQUIVALENCE|"The investigational regimen 4-sites, 1-week ID PEP will be declared as non-inferior to currently recommended 2-sites TRC ID PEP regimen if the lower bound of the two sided 95% confidence interval around of the observed GMC ratio is greater than 0.667 (Day 181)"|Vaccine Group Ratios|1.22|||||TWO_SIDED|95.0|0.94|1.59|||ANOVA|||||1.59|0.94|
72366495|NCT02177032|144243667|NON_INFERIORITY_OR_EQUIVALENCE|"The investigational regimen 4-sites, 1-week ID PEP will be declared as non-inferior to currently recommended 2-sites TRC ID PEP regimen if the lower bound of the two sided 95% confidence interval around of the observed GMC ratio is greater than 0.667 (Day 366)"|Vaccine Group Ratios|1.67|||||TWO_SIDED|95.0|1.27|2.19|||ANOVA|||||2.19|1.27|
72366496|NCT02177032|144243668|NON_INFERIORITY_OR_EQUIVALENCE|"The non-inferiority in immune response of the 4-sites, 1-week (4-4-4-0-0) ID PEP regimen compared to the currently recommended 2-sites TRC (2-2-2-0-2) ID PEP regimen, with or without HRIG, will be established If the lower bound of the two sided 95% confidence interval around the differences of the percentage of subject with RVNA titer ≥ 0.5 IU/ml at Day 8 is \> -0.05 (non-inferiority margin)."|Protection Rate Differences|9.0|||||TWO_SIDED|95.0|3.8|13.9|||Fisher Exact|||||13.9|3.8|
72366497|NCT02177032|144243668|NON_INFERIORITY_OR_EQUIVALENCE|"The non-inferiority in immune response of the 4-sites, 1-week (4-4-4-0-0) ID PEP regimen compared to the currently recommended 2-sites TRC (2-2-2-0-2) ID PEP regimen, with or without HRIG, will be established If the lower bound of the two sided 95% confidence interval around the differences of the percentage of subject with RVNA titer ≥ 0.5 IU/ml at Day 15 is \> -0.05 (non-inferiority margin)."|Protection Rate Differences|0.0|||||TWO_SIDED|95.0|-1.0|1.6|||Fisher Exact|||||1.6|-1|
72368810|NCT02637037|144247320|NON_INFERIORITY_OR_EQUIVALENCE|If the 90% CIs for both dapagliflozin and metformin geometric mean ratio of AUC is entirely contained within an 80.00% to 125.00% interval, it will be concluded the 2 manufacturing sites are bioequivalent.|Ratios of Geometric means|1.01|||||TWO_SIDED|90.0|0.95|1.06||||||Metformin: Statistical Assessment of Bioequivalence for Metformin following administration Dapagliflozin/Metformin XR 5/500 mg for Treatment C and D.||1.06|0.95|
72366498|NCT02177032|144243668|NON_INFERIORITY_OR_EQUIVALENCE|"The non-inferiority in immune response of the 4-sites, 1-week (4-4-4-0-0) ID PEP regimen compared to the currently recommended 2-sites TRC (2-2-2-0-2) ID PEP regimen, with or without HRIG, will be established If the lower bound of the two sided 95% confidence interval around the differences of the percentage of subject with RVNA titer ≥ 0.5 IU/ml at Day 91 is \> -0.05 (non-inferiority margin)."|Protection Rate Differences|-3.0|||||TWO_SIDED|95.0|-6.0|-1.4|||Fisher Exact|||||-1.4|-6|
72366499|NCT02177032|144243668|NON_INFERIORITY_OR_EQUIVALENCE|"The non-inferiority in immune response of the 4-sites, 1-week (4-4-4-0-0) ID PEP regimen compared to the currently recommended 2-sites TRC (2-2-2-0-2) ID PEP regimen, with or without HRIG, will be established If the lower bound of the two sided 95% confidence interval around the differences of the percentage of subject with RVNA titer ≥ 0.5 IU/ml at Day 181 is \> -0.05 (non-inferiority margin)."|Protection Rate Differences|-1.0|||||TWO_SIDED|95.0|-4.5|3.2|||Fisher Exact|||||3.2|-4.5|
72366500|NCT02177032|144243668|NON_INFERIORITY_OR_EQUIVALENCE|"The non-inferiority in immune response of the 4-sites, 1-week (4-4-4-0-0) ID PEP regimen compared to the currently recommended 2-sites TRC (2-2-2-0-2) ID PEP regimen, with or without HRIG, will be established If the lower bound of the two sided 95% confidence interval around the differences of the percentage of subject with RVNA titer ≥ 0.5 IU/ml at Day 366 is \> -0.05 (non-inferiority margin)."|Protection Rate Differences|6.0|||||TWO_SIDED|95.0|1.3|11.5|||Fisher Exact|||||11.5|1.3|
72366501|NCT02177032|144243669|NON_INFERIORITY_OR_EQUIVALENCE|"The non-inferiority in immune response of the 4-sites, 1-week (4-4-4-0-0) ID PEP regimen of the PCEC vaccine, with HRIG administration, compared to that of the new 4-sites, 1-week (4-4-4-0-0) ID PEP regimen of the PCEC vaccine, without HRIG administration, in adult subjects will be established if the lower bound of the two sided 95% confidence interval around the differences of the percentage of subject with RVNA titer ≥ 0.5 IU/ml at Day 8 is \> -0.05 (non-inferiority margin)."|Protection Rate Differences|-11.0|||||TWO_SIDED|95.0|-19.6|-1.0|||Fisher Exact|||||-1|-19.6|
72366502|NCT02177032|144243669|NON_INFERIORITY_OR_EQUIVALENCE|"The non-inferiority in immune response of the 4-sites, 1-week (4-4-4-0-0) ID PEP regimen of the PCEC vaccine, with HRIG administration, compared to that of the new 4-sites, 1-week (4-4-4-0-0) ID PEP regimen of the PCEC vaccine, without HRIG administration, in adult subjects will be established if the lower bound of the two sided 95% confidence interval around the differences of the percentage of subject with RVNA titer ≥ 0.5 IU/ml at Day 15 is \> -0.05 (non-inferiority margin)."|Protection Rate Differences|0.0|||||TWO_SIDED|95.0|-5.6|2.6|||Fisher Exact|||||2.6|-5.6|
72366503|NCT02177032|144243669|NON_INFERIORITY_OR_EQUIVALENCE|"The non-inferiority in immune response of the 4-sites, 1-week (4-4-4-0-0) ID PEP regimen of the PCEC vaccine, with HRIG administration, compared to that of the new 4-sites, 1-week (4-4-4-0-0) ID PEP regimen of the PCEC vaccine, without HRIG administration, in adult subjects will be established if the lower bound of the two sided 95% confidence interval around the differences of the percentage of subject with RVNA titer ≥ 0.5 IU/ml at Day 91 is \> -0.05 (non-inferiority margin)."|Protection Rate Differences|-15.0|||||TWO_SIDED|95.0|-26.0|-7.1|||Fisher Exact|||||-7.1|-26|
72366504|NCT02177032|144243669|NON_INFERIORITY_OR_EQUIVALENCE|"The non-inferiority in immune response of the 4-sites, 1-week (4-4-4-0-0) ID PEP regimen of the PCEC vaccine, with HRIG administration, compared to that of the new 4-sites, 1-week (4-4-4-0-0) ID PEP regimen of the PCEC vaccine, without HRIG administration, in adult subjects will be established if the lower bound of the two sided 95% confidence interval around the differences of the percentage of subject with RVNA titer ≥ 0.5 IU/ml at Day 181 is \> -0.05 (non-inferiority margin)."|Protection Rate Differences|-17.0|||||TWO_SIDED|95.0|-29.0|-7.1|||Fisher Exact|||||-7.1|-29|
72366505|NCT02177032|144243669|NON_INFERIORITY_OR_EQUIVALENCE|"The non-inferiority in immune response of the 4-sites, 1-week (4-4-4-0-0) ID PEP regimen of the PCEC vaccine, with HRIG administration, compared to that of the new 4-sites, 1-week (4-4-4-0-0) ID PEP regimen of the PCEC vaccine, without HRIG administration, in adult subjects will be established if the lower bound of the two sided 95% confidence interval around the differences of the percentage of subject with RVNA titer ≥ 0.5 IU/ml at Day 366 is \> -0.05 (non-inferiority margin)."|Protection Rate Differences|-25.0|||||TWO_SIDED|95.0|-37.8|-13.2|||Fisher Exact|||||-13.2|-37.8|
72366506|NCT03096288|144243688|SUPERIORITY||Mean Difference (Final Values)|22.0||||0.169|TWO_SIDED|95.0|-9.0|52.0|||t-test, 2 sided|||||52|-9|0.169
72366507|NCT03096288|144243688|SUPERIORITY||Median Difference (Final Values)|17.0||||0.236|TWO_SIDED|95.0|-11.0|45.0|||t-test, 2 sided|||||45|-11|0.236
72366508|NCT02558296|144243691|SUPERIORITY|Rejection of the null hypothesis would imply that the mean change in baseline HbA1c from baseline to Week 24 was less than the mean change in the placebo arm by a value that could not be attributed to chance alone.|Mean Difference (Net)|-0.48|||<|0.0001|TWO_SIDED|95.0|-0.56|-0.39||P-value is based on one sided statistical tests using a 0.025 level of significance.|Mixed-effects repeated measures|Region, baseline eGFR categories and BMI, history of heart failure, insulin use (Y/N), treatment, visit and baseline HbA1c as fixed effect covariate.||The null hypothesis for the primary endpoint was that the mean change in HbA1c from baseline to Week 24 in the bexagliflozin arm would be equal to or greater than the mean change in the placebo arm.||-0.39|-0.56|<0.0001
72366509|NCT02558296|144243692|SUPERIORITY|Rejection of the null hypothesis would imply that the mean change in baseline HbA1c from baseline to Week 24 was less than the mean change in the placebo arm by a value that could not be attributed to chance alone.|Mean Difference (Net)|-0.52|||<|0.0001|TWO_SIDED|95.0|-0.65|-0.4||P-value is based on one sided statistical tests using a 0.025 level of significance.|Mixed-effects repeated measures|Region, baseline eGFR categories, history of heart failure, treatment, visit and baseline HbA1c as fixed effect covariate.||The null hypothesis for the secondary endpoint was that the mean change in HbA1c from baseline to Week 24 in the bexagliflozin arm would be equal to or greater than the mean change in the placebo arm.||-0.40|-0.65|<0.0001
72431782|NCT02688621|144375449|SUPERIORITY||||||<|0.01|||||||Mixed Models Analysis|||The study was designed to detect a 2.2-kg group weight loss difference between groups with a standard deviation of 5.8 kg,4,5 a 5% Type I error rate, and 80% power. To adjust for possible clustering effects in this nested design, the adjusted variance estimate was increased to 7.67, calculated using a conservative intraclass correlation coefficient of 0.05.||||<.01
72366510|NCT02558296|144243693|SUPERIORITY|Rejection of the null hypothesis would imply that the mean change in body weight from baseline to Week 48 was less than the mean change in the placebo arm by a value that could not be attributed to chance alone.|Mean Difference (Net)|-2.65|||<|0.0001|TWO_SIDED|95.0|-3.07|-2.24||P-value is presented based on one-sided statistical tests using a 0.025 level of significance.|Mixed-effects repeated measures|Region, baseline HbA1c and eGFR, history of heart failure, insulin use (Y/N), treatment, visit and baseline body weight as fixed effect covariate.||The null hypothesis for the secondary endpoint was that the mean change in body weight from baseline to Week 48 in the bexagliflozin arm would be equal to or greater than the mean change in the placebo arm.||-2.24|-3.07|<0.0001
72366511|NCT02558296|144243694|SUPERIORITY|Rejection of the null hypothesis would imply that the mean change in systolic blood pressure from baseline to Week 24 was less than the mean change in the placebo arm by a value that could not be attributed to chance alone.|Mean Difference (Net)|-2.96||||0.0112|TWO_SIDED|95.0|-5.51|-0.42||P-value is presented based on one-sided statistical tests using a 0.025 level of significance.|Mixed-effects repeated measures|Region, baseline HbA1c, GFR categories, BMI, history of heart failure, insulin use (Y/N), treatment, visit and baseline SBP as fixed effect covariate.||The null hypothesis for the secondary endpoint was that the mean change in systolic blood pressure from baseline to Week 24 in the bexagliflozin arm would be equal to or greater than the mean change in the placebo arm.||-0.42|-5.51|0.0112
72366512|NCT02558296|144243695|SUPERIORITY|Rejection of the null hypothesis would imply that the mean change in baseline HbA1c from baseline to Week 6 was less than that in the placebo arm by a value that could not be attributed to chance alone.|Mean Difference (Final Values)|-0.45|||<|0.0001|TWO_SIDED|95.0|-0.5|-0.39||P-value is based on one sided statistical tests using a 0.025 level of significance.|Mixed-effects repeated measures|Region, baseline eGFR categories and BMI, history of heart failure, insulin use (Y/N), treatment, visit and baseline HbA1c as fixed effect covariate.||The null hypothesis for the exploratory endpoint was that the mean change in HbA1c from baseline to Week 6 in the bexagliflozin arm would be equal to or greater than the mean change in the placebo arm.||-0.39|-0.50|<0.0001
72366513|NCT02558296|144243695|NON_INFERIORITY|Rejection of the null hypothesis would imply that the mean change in baseline HbA1c from baseline to Week 12 was less than that in the placebo arm by a value that could not be attributed to chance alone.|Mean Difference (Final Values)|-0.56|||<|0.0001|TWO_SIDED|95.0|-0.63|-0.49||P-value is based on one sided statistical tests using a 0.025 level of significance.|Mixed-effects repeated measures|Region, baseline eGFR categories and BMI, history of heart failure, insulin use (Y/N), treatment, visit and baseline HbA1c as fixed effect covariate.||The null hypothesis for the exploratory endpoint was that the mean change in HbA1c from baseline to Week 12 in the bexagliflozin arm would be equal to or greater than the mean change in the placebo arm.||-0.49|-0.63|<0.0001
72366514|NCT02558296|144243695|NON_INFERIORITY|Rejection of the null hypothesis would imply that the mean change in baseline HbA1c from baseline to Week 24 was less than that in the placebo arm by a value that could not be attributed to chance alone.|Mean Difference (Final Values)|-0.47|||<|0.0001|TWO_SIDED|95.0|-0.56|-0.38||P-value is based on one sided statistical tests using a 0.025 level of significance.|Mixed-effects repeated measures|Region, baseline eGFR categories and BMI, history of heart failure, insulin use (Y/N), treatment, visit and baseline HbA1c as fixed effect covariate.||The null hypothesis for the exploratory endpoint was that the mean change in HbA1c from baseline to Week 24 in the bexagliflozin arm would be equal to or greater than the mean change in the placebo arm.||-0.38|-0.56|<0.0001
72366515|NCT02558296|144243695|NON_INFERIORITY|Rejection of the null hypothesis would imply that the mean change in baseline HbA1c from baseline to Week 36 was less than that in the placebo arm by a value that could not be attributed to chance alone.|Mean Difference (Final Values)|-0.47|||<|0.0001|TWO_SIDED|95.0|-0.56|-0.38||P-value is based on one sided statistical tests using a 0.025 level of significance.|Mixed-effects repeated measures|Region, baseline eGFR categories and BMI, history of heart failure, insulin use (Y/N), treatment, visit and baseline HbA1c as fixed effect covariate.||The null hypothesis for the exploratory endpoint was that the mean change in HbA1c from baseline to Week 36 in the bexagliflozin arm would be equal to or greater than the mean change in the placebo arm.||-0.38|-0.56|<0.0001
72366516|NCT02558296|144243695|NON_INFERIORITY|Rejection of the null hypothesis would imply that the mean change in baseline HbA1c from baseline to Week 48 was less than that in the placebo arm by a value that could not be attributed to chance alone.|Mean Difference (Final Values)|-0.46|||<|0.0001|TWO_SIDED|95.0|-0.56|-0.37||P-value is based on one sided statistical tests using a 0.025 level of significance.|Mixed-effects repeated measures|Region, baseline eGFR categories and BMI, history of heart failure, insulin use (Y/N), treatment, visit and baseline HbA1c as fixed effect covariate.||The null hypothesis for the exploratory endpoint was that the mean change in HbA1c from baseline to Week 48 in the bexagliflozin arm would be equal to or greater than the mean change in the placebo arm.||-0.37|-0.56|<0.0001
72366517|NCT02558296|144243695|NON_INFERIORITY|Rejection of the null hypothesis would imply that the mean change in baseline HbA1c from baseline to Week 72 was less than that in the placebo arm by a value that could not be attributed to chance alone.|Mean Difference (Final Values)|-0.42|||<|0.0001|TWO_SIDED|95.0|-0.54|-0.31||P-value is based on one sided statistical tests using a 0.025 level of significance.|Mixed-effects repeated measures|Region, baseline eGFR categories and BMI, history of heart failure, insulin use (Y/N), treatment, visit and baseline HbA1c as fixed effect covariate.||The null hypothesis for the exploratory endpoint was that the mean change in HbA1c from baseline to Week 72 in the bexagliflozin arm would be equal to or greater than the mean change in the placebo arm.||-0.31|-0.54|<0.0001
72366518|NCT02558296|144243695|NON_INFERIORITY|Rejection of the null hypothesis would imply that the mean change in baseline HbA1c from baseline to Week 96 was less than that in the placebo arm by a value that could not be attributed to chance alone.|Mean Difference (Final Values)|-0.39|||<|0.0001|TWO_SIDED|95.0|-0.51|-0.27||P-value is based on one sided statistical tests using a 0.025 level of significance.|Mixed-effects repeated measures|Region, baseline eGFR categories and BMI, history of heart failure, insulin use (Y/N), treatment, visit and baseline HbA1c as fixed effect covariate.||The null hypothesis for the exploratory endpoint was that the mean change in HbA1c from baseline to Week 96 in the bexagliflozin arm would be equal to or greater than the mean change in the placebo arm.||-0.27|-0.51|<0.0001
72366519|NCT02558296|144243695|NON_INFERIORITY|Rejection of the null hypothesis would imply that the mean change in baseline HbA1c from baseline to Week 120 was less than that in the placebo arm by a value that could not be attributed to chance alone.|Mean Difference (Final Values)|-0.43|||<|0.0001|TWO_SIDED|95.0|-0.56|-0.3||P-value is based on one sided statistical tests using a 0.025 level of significance.|Mixed-effects repeated measures|Region, baseline eGFR categories and BMI, history of heart failure, insulin use (Y/N), treatment, visit and baseline HbA1c as fixed effect covariate.||The null hypothesis for the exploratory endpoint was that the mean change in HbA1c from baseline to Week 120 in the bexagliflozin arm would be equal to or greater than the mean change in the placebo arm.||-0.30|-0.56|<0.0001
72366520|NCT02558296|144243695|NON_INFERIORITY|Rejection of the null hypothesis would imply that the mean change in baseline HbA1c from baseline to Week 144 was less than that in the placebo arm by a value that could not be attributed to chance alone.|Mean Difference (Final Values)|-0.38|||<|0.0001|TWO_SIDED|95.0|-0.54|-0.23||P-value is based on one sided statistical tests using a 0.025 level of significance.|Mixed-effects repeated measures|Region, baseline eGFR categories and BMI, history of heart failure, insulin use (Y/N), treatment, visit and baseline HbA1c as fixed effect covariate.||The null hypothesis for the exploratory endpoint was that the mean change in HbA1c from baseline to Week 144 in the bexagliflozin arm would be equal to or greater than the mean change in the placebo arm.||-0.23|-0.54|<0.0001
72366521|NCT02558296|144243695|NON_INFERIORITY|Rejection of the null hypothesis would imply that the mean change in baseline HbA1c from baseline to Week 168 was less than that in the placebo arm by a value that could not be attributed to chance alone.|Mean Difference (Final Values)|-0.27||||0.0045|TWO_SIDED|95.0|-0.47|-0.07||P-value is based on one sided statistical tests using a 0.025 level of significance.|Mixed-effects repeated measures|Region, baseline eGFR categories and BMI, history of heart failure, insulin use (Y/N), treatment, visit and baseline HbA1c as fixed effect covariate.||The null hypothesis for the exploratory endpoint was that the mean change in HbA1c from baseline to Week 168 in the bexagliflozin arm would be equal to or greater than the mean change in the placebo arm.||-0.07|-0.47|0.0045
72366522|NCT02558296|144243696|NON_INFERIORITY|Rejection of the null hypothesis would imply that the mean change in baseline FPG from baseline to Week 6 was less than that in the placebo arm by a value that could not be attributed to chance alone.|Mean Difference (Final Values)|-1.35|||<|0.0001|TWO_SIDED|95.0|-1.55|-1.15||P-value is based on one sided statistical tests using a 0.025 level of significance.|Mixed-effects repeated measures|Region, baseline eGFR categories \& BMI, history of HF, insulin use, treatment, visit, hypoglycemic use and baseline FPG as fixed effect covariate.||The null hypothesis for the exploratory endpoint was that the mean change in FPG from baseline to Week 6 in the bexagliflozin arm would be equal to or greater than the mean change in the placebo arm.||-1.15|-1.55|<0.0001
72366523|NCT02558296|144243696|NON_INFERIORITY|Rejection of the null hypothesis would imply that the mean change in baseline FPG from baseline to Week 12 was less than that in the placebo arm by a value that could not be attributed to chance alone.|Mean Difference (Final Values)|-1.39|||<|0.0001|TWO_SIDED|95.0|-1.61|-1.18||P-value is based on one sided statistical tests using a 0.025 level of significance.|Mixed-effects repeated measures|Region, baseline eGFR categories \& BMI, history of HF, insulin use, treatment, visit, hypoglycemic use and baseline FPG as fixed effect covariate.||The null hypothesis for the exploratory endpoint was that the mean change in FPG from baseline to Week 12 in the bexagliflozin arm would be equal to or greater than the mean change in the placebo arm.||-1.18|-1.61|<0.0001
72366524|NCT02558296|144243696|NON_INFERIORITY|Rejection of the null hypothesis would imply that the mean change in baseline FPG from baseline to Week 24 was less than that in the placebo arm by a value that could not be attributed to chance alone.|Mean Difference (Final Values)|-1.39|||<|0.0001|TWO_SIDED|95.0|-1.61|-1.16||P-value is based on one sided statistical tests using a 0.025 level of significance.|Mixed-effects repeated measures|Region, baseline eGFR categories \& BMI, history of HF, insulin use, treatment, visit, hypoglycemic use and baseline FPG as fixed effect covariate.||The null hypothesis for the exploratory endpoint was that the mean change in FPG from baseline to Week 24 in the bexagliflozin arm would be equal to or greater than the mean change in the placebo arm.||-1.16|-1.61|<0.0001
72366525|NCT02558296|144243696|NON_INFERIORITY|Rejection of the null hypothesis would imply that the mean change in baseline FPG from baseline to Week 36 was less than that in the placebo arm by a value that could not be attributed to chance alone.|Mean Difference (Final Values)|-1.15|||<|0.0001|TWO_SIDED|95.0|-1.41|-0.89||P-value is based on one sided statistical tests using a 0.025 level of significance.|Mixed-effects repeated measures|Region, baseline eGFR categories \& BMI, history of HF, insulin use, treatment, visit, hypoglycemic use and baseline FPG as fixed effect covariate.||The null hypothesis for the exploratory endpoint was that the mean change in FPG from baseline to Week 36 in the bexagliflozin arm would be equal to or greater than the mean change in the placebo arm.||-0.89|-1.41|<0.0001
72366526|NCT02558296|144243696|NON_INFERIORITY|Rejection of the null hypothesis would imply that the mean change in baseline FPG from baseline to Week 48 was less than that in the placebo arm by a value that could not be attributed to chance alone.|Mean Difference (Final Values)|-1.23|||<|0.0001|TWO_SIDED|95.0|-1.48|-0.98||P-value is based on one sided statistical tests using a 0.025 level of significance.|Mixed-effects repeated measures|Region, baseline eGFR categories \& BMI, history of HF, insulin use, treatment, visit, hypoglycemic use and baseline FPG as fixed effect covariate.||The null hypothesis for the exploratory endpoint was that the mean change in FPG from baseline to Week 48 in the bexagliflozin arm would be equal to or greater than the mean change in the placebo arm.||-0.98|-1.48|<0.0001
72366527|NCT02558296|144243696|NON_INFERIORITY|Rejection of the null hypothesis would imply that the mean change in baseline FPG from baseline to Week 72 was less than that in the placebo arm by a value that could not be attributed to chance alone.|Mean Difference (Final Values)|-0.99|||<|0.0001|TWO_SIDED|95.0|-1.27|-0.72||P-value is based on one sided statistical tests using a 0.025 level of significance.|Mixed-effects repeated measures|Region, baseline eGFR categories \& BMI, history of HF, insulin use, treatment, visit, hypoglycemic use and baseline FPG as fixed effect covariate.||The null hypothesis for the exploratory endpoint was that the mean change in FPG from baseline to Week 72 in the bexagliflozin arm would be equal to or greater than the mean change in the placebo arm.||-0.72|-1.27|<0.0001
72366528|NCT02558296|144243696|NON_INFERIORITY|Rejection of the null hypothesis would imply that the mean change in baseline FPG from baseline to Week 96 was less than that in the placebo arm by a value that could not be attributed to chance alone.|Mean Difference (Final Values)|-1.2|||<|0.0001|TWO_SIDED|95.0|-1.5|-0.9||P-value is based on one sided statistical tests using a 0.025 level of significance.|Mixed-effects repeated measures|Region, baseline eGFR categories \& BMI, history of HF, insulin use, treatment, visit, hypoglycemic use and baseline FPG as fixed effect covariate.||The null hypothesis for the exploratory endpoint was that the mean change in FPG from baseline to Week 96 in the bexagliflozin arm would be equal to or greater than the mean change in the placebo arm.||-0.90|-1.50|<0.0001
72366529|NCT02558296|144243696|NON_INFERIORITY|Rejection of the null hypothesis would imply that the mean change in baseline FPG from baseline to Week 120 was less than that in the placebo arm by a value that could not be attributed to chance alone.|Mean Difference (Final Values)|-1.15|||<|0.0001|TWO_SIDED|95.0|-1.49|-0.82||P-value is based on one sided statistical tests using a 0.025 level of significance.|Mixed-effects repeated measures|Region, baseline eGFR categories \& BMI, history of HF, insulin use, treatment, visit, hypoglycemic use and baseline FPG as fixed effect covariate.||The null hypothesis for the exploratory endpoint was that the mean change in FPG from baseline to Week 120 in the bexagliflozin arm would be equal to or greater than the mean change in the placebo arm.||-0.82|-1.49|<0.0001
72366530|NCT02558296|144243696|NON_INFERIORITY|Rejection of the null hypothesis would imply that the mean change in baseline FPG from baseline to Week 144 was less than that in the placebo arm by a value that could not be attributed to chance alone.|Mean Difference (Final Values)|-0.63||||0.0008|TWO_SIDED|95.0|-1.01|-0.24||P-value is based on one sided statistical tests using a 0.025 level of significance.|Mixed-effects repeated measures|Region, baseline eGFR categories \& BMI, history of HF, insulin use, treatment, visit, hypoglycemic use and baseline FPG as fixed effect covariate.||The null hypothesis for the exploratory endpoint was that the mean change in FPG from baseline to Week 144 in the bexagliflozin arm would be equal to or greater than the mean change in the placebo arm.||-0.24|-1.01|0.0008
72366531|NCT02558296|144243696|NON_INFERIORITY|Rejection of the null hypothesis would imply that the mean change in baseline FPG from baseline to Week 168 was less than that in the placebo arm by a value that could not be attributed to chance alone.|Mean Difference (Final Values)|-0.5||||0.0462|TWO_SIDED|95.0|-1.09|0.08||P-value is based on one sided statistical tests using a 0.025 level of significance.|Mixed-effects repeated measures|Region, baseline eGFR categories \& BMI, history of HF, insulin use, treatment, visit, hypoglycemic use and baseline FPG as fixed effect covariate.||The null hypothesis for the exploratory endpoint was that the mean change in FPG from baseline to Week 168 in the bexagliflozin arm would be equal to or greater than the mean change in the placebo arm.||0.08|-1.09|0.0462
72366532|NCT02558296|144243697|SUPERIORITY||Odds Ratio (OR)|0.3|||<|0.0001|TWO_SIDED|95.0|0.22|0.41||P-value is based on one sided statistical tests using a 0.025 level of significance.|Regression, Logistic|Region, baseline eGFR categories \& BMI, history of heart failure, insulin use (Y/N), treatment and baseline HbA1c as fixed effect covariate.|Odds ratio is calculated as the odds ratio of bexagliflozin over placebo.|||0.41|0.22|<0.0001
72366533|NCT02558296|144243698|SUPERIORITY||Hazard Ratio (HR)|0.41|||<|0.0001|TWO_SIDED|95.0|0.35|0.49||P-value is based on one sided statistical tests using a 0.025 level of significance.|Regression, Cox|Region, baseline eGFR categories \& BMI, history of heart failure, insulin use (Y/N), treatment and baseline HbA1c as fixed effect covariate.|Hazard ratio and p-value were estimated using Cox regression model for time to first event in the bexagliflozin arm vs. placebo arm during entire study.|||0.49|0.35|<0.0001
72366534|NCT02558296|144243699|SUPERIORITY||Odds Ratio (OR)|2.04||||0.0005|TWO_SIDED|95.0|1.33|3.11||P-value is based on one sided statistical tests using a 0.025 level of significance.|Regression, Logistic|Region, baseline eGFR categories \& BMI, history of heart failure, insulin use (Y/N), treatment and baseline HbA1c as fixed effect covariate.|Odds ratio is calculated as the ratio of bexagliflozin over placebo.|||3.11|1.33|0.0005
72366535|NCT02558296|144243700|SUPERIORITY||Hazard Ratio (HR)|1.82|||<|0.0001|TWO_SIDED|95.0|1.4|2.38||P-value is based on one sided statistical tests using a 0.025 level of significance.|Regression, Cox|Region, baseline eGFR categories \& BMI, history of heart failure, insulin use (Y/N), treatment and baseline HbA1c as fixed effect covariate.|Hazard ratio and p-value were estimated using Cox regression model for time to first event in the bexagliflozin arm vs. placebo arm during the entire study.|||2.38|1.40|<0.0001
72366536|NCT02558296|144243701|SUPERIORITY||Odds Ratio (OR)|0.63||||0.0803|TWO_SIDED|95.0|0.33|1.2||P-value is based on one sided statistical tests using a 0.025 level of significance.|Regression, Logistic|Region, baseline eGFR categories \& BMI, history of heart failure, insulin use (Y/N), treatment and baseline HbA1c as fixed effect covariate.|Odds ratio is calculated as the odds ratio of bexagliflozin over placebo.|||1.20|0.33|0.0803
72366537|NCT02558296|144243701|SUPERIORITY||Odds Ratio (OR)|0.47||||0.0272|TWO_SIDED|95.0|0.22|1.01||P-value is based on one sided statistical tests using a 0.025 level of significance.|Regression, Logistic|Region, baseline eGFR categories \& BMI, history of heart failure, insulin use (Y/N), treatment and baseline HbA1c as fixed effect covariate.|Odds ratio is calculated as the odds ratio of bexagliflozin over placebo.|||1.01|0.22|0.0272
72366538|NCT02558296|144243701|SUPERIORITY||Hazard Ratio (HR)|0.63||||0.0757|TWO_SIDED|95.0|0.34|1.18||P-value is based on one sided statistical tests using a 0.025 level of significance.|Regression, Cox|Region, baseline eGFR categories \& BMI, history of heart failure, insulin use (Y/N), treatment and baseline HbA1c as fixed effect covariate.|Hazard ratio and p-value were estimated using Cox regression model for treatment comparison vs. placebo.|||1.18|0.34|0.0757
72366539|NCT02558296|144243701|SUPERIORITY||Hazard Ratio (HR)|0.49||||0.0273|TWO_SIDED|95.0|0.23|1.01||P-value is based on one sided statistical tests using a 0.025 level of significance.|Regression, Cox|Region, baseline eGFR categories \& BMI, history of heart failure, insulin use (Y/N), treatment and baseline HbA1c as fixed effect covariate.|Hazard ratio and p-value were estimated using Cox regression model for treatment comparison vs. placebo.|||1.01|0.23|0.0273
72366540|NCT00346697|144243739|SUPERIORITY_OR_OTHER|||||||0.01|||||||Wilcoxon (Mann-Whitney)|||||||0.01
72366541|NCT00346697|144243740|SUPERIORITY_OR_OTHER|||||||0.8|||||||Wilcoxon (Mann-Whitney)|||||||.80
72366542|NCT00346697|144243741|SUPERIORITY_OR_OTHER|||||||0.72|||||||Wilcoxon (Mann-Whitney)|||||||0.72
72366543|NCT00346697|144243742|SUPERIORITY_OR_OTHER|||||||0.16|||||||Wilcoxon (Mann-Whitney)|||||||0.16
72366544|NCT00346697|144243743|SUPERIORITY_OR_OTHER|||||||0.96|||||||Wilcoxon (Mann-Whitney)|||||||0.96
72366545|NCT00346697|144243744|SUPERIORITY_OR_OTHER|||||||0.7|||||||Wilcoxon (Mann-Whitney)|||||||0.70
72366546|NCT00346697|144243745|SUPERIORITY_OR_OTHER|||||||0.2|||||||Wilcoxon (Mann-Whitney)|||||||0.20
72366547|NCT00346697|144243746|SUPERIORITY_OR_OTHER|||||||0.006|||||||Wilcoxon (Mann-Whitney)|||||||0.006
72366548|NCT00346697|144243747|SUPERIORITY_OR_OTHER|||||||0.04|||||||Wilcoxon (Mann-Whitney)|||||||0.04
72366549|NCT00346697|144243748|SUPERIORITY_OR_OTHER|||||||0.89|||||||Wilcoxon (Mann-Whitney)|||||||0.89
72366550|NCT00346697|144243749|SUPERIORITY_OR_OTHER|||||||0.89|||||||Wilcoxon (Mann-Whitney)|||||||0.89
72366551|NCT00346697|144243750|SUPERIORITY_OR_OTHER|||||||0.25|||||||Wilcoxon (Mann-Whitney)|||||||0.25
72366552|NCT00346697|144243751|SUPERIORITY_OR_OTHER|||||||0.14|||||||Wilcoxon (Mann-Whitney)|||||||0.14
72366553|NCT00346697|144243752|SUPERIORITY_OR_OTHER|||||||0.12|||||||Wilcoxon (Mann-Whitney)|||||||0.12
72366554|NCT00346697|144243753|SUPERIORITY_OR_OTHER|||||||0.3|||||||Wilcoxon (Mann-Whitney)|||||||0.30
72366555|NCT01055197|144243812|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.44||||0.2103|TWO_SIDED|95.0|0.82|2.53|||Log Rank|||The null hypothesis (H0) was that PCI + RT is not effective versus the alternative hypothesis (H1) that PCI + RT is effective. Assumptions were that PCI alone would have hazard rate λc of 1.204 and PCI + RT a hazard rate λc of 0.799 (hazard ratio λt/λc = 0.663). At each planned analysis, the p-value from the log-rank test statistic assessing overall survival was compared to the nominal significance level. The final targeted accrual was 154.||2.53|0.82|0.2103
72366556|NCT01055197|144243813|SUPERIORITY|||||||0.24|||||||Fisher Exact|2-sided significance level of 0.05||||||0.24
72366557|NCT01055197|144243815|SUPERIORITY|||||||0.0102|||||||Log Rank|2-sided significance level of 0.05||||||0.0102
72366558|NCT00538902|144243820|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.19||||0.026||95.0|1.09|4.39||Each comparison was tested at the 2-sided alpha level of 0.05. Subjects with missing data were imputed to be non-responders. The overall type I error rate was preserved by a hierarchical stepwise closed testing procedure.|Cochran-Mantel-Haenszel|||A sample size of 42 subjects in the placebo group and 84 subjects in each of the adalimumab groups was needed to achieve 98% power to detect that the ACR20 response rate in the 80 mg adalimumab group was different from placebo and to achieve 84% power to detect that the 40 mg adalimumab group was different from placebo.||4.39|1.09|0.026
72366559|NCT00538902|144243820|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.68||||0.004||95.0|1.35|5.3||Each comparison was tested at the 2-sided alpha level of 0.05. Subjects with missing data were imputed to be non-responders. The overall type I error rate was preserved by a hierarchical stepwise closed testing procedure.|Cochran-Mantel-Haenszel|||A sample size of 42 subjects in the placebo group and 84 subjects in each of the adalimumab groups was needed to achieve 98% power to detect that the ACR20 response rate in the 80 mg adalimumab group was different from placebo and to achieve 84% power to detect that the 40 mg adalimumab group was different from placebo.||5.30|1.35|0.004
72366560|NCT00538902|144243821|SUPERIORITY_OR_OTHER|||||||0.009||||||The between-treatment comparison between each adalimumab group vs. placebo was performed at the 2-sided alpha = 0.05 significance level, without using a stepwise testing procedure or alpha adjustment.|Cochran-Mantel-Haenszel|Percentage ACR responders at Week 12 were compared between adalimumab and placebo groups, where missing ACR responses were imputed as non-responder.||||||0.009
72366561|NCT00538902|144243821|SUPERIORITY_OR_OTHER|||||||0.121|||||||Cochran-Mantel-Haenszel|||||||0.121
72366562|NCT03739203|144243837|SUPERIORITY||Least Squares Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.88||0.6798|TWO_SIDED|95.0|-2.1|1.37||p-value estimated by Mixed-effects Model for Repeated Measure from test of no difference between cariprazine dose group and placebo at Week 6.|MMRM|MMRM=Fixed effects:treatment group(TG),ADT failure category,visit,TG-by-visit;Covariates:Baseline(BL)value\& BL by-visit interaction.||||1.37|-2.10|0.6798
72366563|NCT03739203|144243837|SUPERIORITY||Least Squares Mean Difference|-1.4|STANDARD_ERROR_OF_MEAN|0.89||0.1245|TWO_SIDED|95.0|-3.11|0.38||p-value estimated by Mixed-effects Model for Repeated Measure from test of no difference between cariprazine dose group and placebo at Week 6.|MMRM|MMRM=Fixed effects:treatment group(TG), ADT failure category,visit,TG-by-visit;Covariates:Baseline(BL)value\& BL by-visit interaction.||||0.38|-3.11|0.1245
72366564|NCT03739203|144243838|SUPERIORITY||Least Squares Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.11||0.5152|TWO_SIDED|95.0|-0.29|0.15||p-value estimated by Mixed-effects Model for Repeated Measure from test of no difference between cariprazine dose group and placebo at Week 6.|MMRM|MMRM=Fixed effects:treatment group(TG),ADT failure category,visit,TG-by-visit;Covariates:Baseline(BL)value\& BL by-visit interaction.||||0.15|-0.29|0.5152
72366565|NCT03739203|144243838|SUPERIORITY||Least Squares Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.11||0.0573|TWO_SIDED|95.0|-0.43|0.01||p-value estimated by Mixed-effects Model for Repeated Measure from test of no difference between cariprazine dose group and placebo at Week 6.|MMRM|MMRM=Fixed effects:treatment group(TG), ADT failure category,visit,TG-by-visit;Covariates:Baseline(BL)value\& BL by-visit interaction.||||0.01|-0.43|0.0573
72366566|NCT01782378|144243849|SUPERIORITY||Mean Difference (Final Values)|-0.55|STANDARD_ERROR_OF_MEAN|0.33|<|0.01|TWO_SIDED|||||without adjustment for multiple comparisons Mixed effects model with the assumption that 'subject factor' was a random effect. p-value threshold of p\<.10|ANOVA|Adjusted for baseline scores; co-variate adjustments did not affect any of the results||||||<0.01
72366567|NCT01782378|144243850|SUPERIORITY||Mean Difference (Final Values)|-0.13|STANDARD_ERROR_OF_MEAN|0.88||0.88|TWO_SIDED|||||without adjustment for multiple comparisons Mixed effects model with the assumption that 'subject factor' was a random effect. p-value threshold of p\<.10|ANOVA|Adjusted for baseline scores; co-variate adjustments did not affect any of the results.||||||0.88
72366568|NCT01782378|144243851|SUPERIORITY||Mean Difference (Final Values)|-0.14|STANDARD_ERROR_OF_MEAN|0.59||0.81|TWO_SIDED|||||without adjustment for multiple comparisons Mixed effects model with the assumption that 'subject factor' was a random effect. p-value threshold of p\<.10|ANOVA|Adjusted for baseline scores; co-variate adjustments did not affect any of the results.||||||0.81
72366569|NCT01782378|144243852|SUPERIORITY||Mean Difference (Final Values)|3.52|STANDARD_ERROR_OF_MEAN|2.88||0.23|TWO_SIDED|||||without adjustment for multiple comparisons Mixed effects model with the assumption that 'subject factor' was a random effect. p-value threshold of p\<.10|ANOVA|Adjusted for baseline scores; co-variate adjustments did not affect any of the results||||||0.23
72366570|NCT01782378|144243853|SUPERIORITY||Mean Difference (Final Values)|11.39|STANDARD_ERROR_OF_MEAN|7.08|<|0.12|TWO_SIDED|||||without adjustment for multiple comparisons Mixed effects model with the assumption that 'subject factor' was a random effect. p-value threshold of p\<.10|ANOVA|Adjusted for baseline scores; co-variate adjustments did not affect any of the results.||||||<0.12
72366571|NCT01782378|144243854|SUPERIORITY||Mean Difference (Final Values)|-1.93|STANDARD_ERROR_OF_MEAN|2.93|<|0.52|TWO_SIDED|||||without adjustment for multiple comparisons Mixed effects model with the assumption that 'subject factor' was a random effect. p-value threshold of p\<.10|ANOVA|Adjusted for baseline scores; co-variate adjustments did not affect any of the results.||||||<0.52
72366572|NCT01782378|144243855|SUPERIORITY||Mean Difference (Final Values)|3.92|STANDARD_ERROR_OF_MEAN|3.51|<|0.27|TWO_SIDED|||||without adjustment for multiple comparisons Mixed effects model with the assumption that 'subject factor' was a random effect. p-value threshold of p\<.10|ANOVA|Adjusted for baseline scores; co-variate adjustments did not affect any of the results.||||||<0.27
72366573|NCT01782378|144243856|SUPERIORITY||Mean Difference (Final Values)|-2.06|STANDARD_ERROR_OF_MEAN|2.26|<|0.37|TWO_SIDED|||||without adjustment for multiple comparisons Mixed effects model with the assumption that 'subject factor' was a random effect. p-value threshold of p\<.10|ANOVA|Adjusted for baseline scores; co-variate adjustments did not affect any of the results.||||||<0.37
72366574|NCT01782378|144243857|SUPERIORITY||Mean Difference (Final Values)|-0.73|STANDARD_ERROR_OF_MEAN|0.78|<|0.36|TWO_SIDED|||||without adjustment for multiple comparisons Mixed effects model with the assumption that 'subject factor' was a random effect. p-value threshold of p\<.10|ANOVA|Adjusted for baseline scores; co-variate adjustments did not affect any of the results.||||||<0.36
72366575|NCT01782378|144243858|SUPERIORITY||Mean Difference (Final Values)|0.5|STANDARD_ERROR_OF_MEAN|0.68|<|0.46|TWO_SIDED|||||without adjustment for multiple comparisons Mixed effects model with the assumption that 'subject factor' was a random effect. p-value threshold of p\<.10|ANOVA|Adjusted for baseline scores; co-variate adjustments did not affect any of the results||||||<0.46
72366576|NCT01782378|144243859|SUPERIORITY||Mean Difference (Final Values)|-0.17|STANDARD_ERROR_OF_MEAN|0.83|<|0.84|TWO_SIDED|||||without adjustment for multiple comparisons Mixed effects model with the assumption that 'subject factor' was a random effect. p-value threshold of p\<.10|ANOVA|Adjusted for baseline scores; co-variate adjustments did not affect any of the results.||||||<0.84
72366577|NCT01782378|144243860|SUPERIORITY||Mean Difference (Final Values)|0.07|STANDARD_ERROR_OF_MEAN|0.75|<|0.93|TWO_SIDED|||||without adjustment for multiple comparisons Mixed effects model with the assumption that 'subject factor' was a random effect. p-value threshold of p\<.10|ANOVA|Adjusted for baseline scores; co-variate adjustments did not affect any of the results.||||||<0.93
72366578|NCT01782378|144243861|SUPERIORITY||Mean Difference (Final Values)|0.56|STANDARD_ERROR_OF_MEAN|3.02|<|0.85|TWO_SIDED|||||without adjustment for multiple comparisons Mixed effects model with the assumption that 'subject factor' was a random effect. p-value threshold of p\<.10|ANOVA|Adjusted for baseline scores; co-variate adjustments did not affect any of the results.||||||<0.85
72366579|NCT01782378|144243862|SUPERIORITY|Adjusted for baseline scores; co-variate adjustments did not affect any of the results.|Mean Difference (Final Values)|-14.43|STANDARD_ERROR_OF_MEAN|12.54|<|0.26|TWO_SIDED|||||without adjustment for multiple comparisons Mixed effects model with the assumption that 'subject factor' was a random effect. p-value threshold of p\<.10|ANOVA|Adjusted for baseline scores; co-variate adjustments did not affect any of the results that were considered credible.||||||<0.26
72366580|NCT01782378|144243863|SUPERIORITY||Mean Difference (Final Values)|-1.3|STANDARD_ERROR_OF_MEAN|1.7|<|0.45|TWO_SIDED|||||without adjustment for multiple comparisons Mixed effects model with the assumption that 'subject factor' was a random effect. p-value threshold of p\<.10|ANOVA|Adjusted for baseline scores; co-variate adjustments did not affect any of the results.||||||<0.45
72366581|NCT01782378|144243864|SUPERIORITY||Mean Difference (Final Values)|0.87|STANDARD_ERROR_OF_MEAN|1.18|<|0.46|TWO_SIDED|||||without adjustment for multiple comparisons Mixed effects model with the assumption that 'subject factor' was a random effect. p-value threshold of p\<.10|ANOVA|Adjusted for baseline scores; co-variate adjustments did not affect any of the results.||||||<0.46
72366582|NCT01782378|144243865|SUPERIORITY||Mean Difference (Final Values)|-0.66|STANDARD_ERROR_OF_MEAN|1.44|<|0.64|TWO_SIDED|||||without adjustment for multiple comparisons Mixed effects model with the assumption that 'subject factor' was a random effect. p-value threshold of p\<.10|ANOVA|Adjusted for baseline scores; co-variate adjustments did not affect any of the results.||||||<0.64
72366583|NCT01782378|144243866|SUPERIORITY||Mean Difference (Final Values)|0.38|STANDARD_ERROR_OF_MEAN|1.63|<|0.82|TWO_SIDED|||||without adjustment for multiple comparisons Mixed effects model with the assumption that 'subject factor' was a random effect. p-value threshold of p\<.10|ANOVA|Adjusted for baseline scores; co-variate adjustments did not affect any of the results||||||<0.82
72366584|NCT01782378|144243867|SUPERIORITY||Mean Difference (Final Values)|-1.98|STANDARD_ERROR_OF_MEAN|2.53|<|0.43|TWO_SIDED|||||without adjustment for multiple comparisons Mixed effects model with the assumption that 'subject factor' was a random effect. p-value threshold of p\<.10|ANOVA|Adjusted for baseline scores; co-variate adjustments did not affect any of the results||||||<0.43
72366585|NCT01782378|144243868|SUPERIORITY||Mean Difference (Final Values)|0.91|STANDARD_ERROR_OF_MEAN|0.62|<|0.15|TWO_SIDED|||||without adjustment for multiple comparisons Mixed effects model with the assumption that 'subject factor' was a random effect. p-value threshold of p\<.10|ANOVA|Adjusted for baseline scores; co-variate adjustments did not affect any of the results||||||<0.15
72366586|NCT01782378|144243869|SUPERIORITY||Mean Difference (Final Values)|3.36|STANDARD_ERROR_OF_MEAN|1.86||0.08|TWO_SIDED|||||without adjustment for multiple comparisons Mixed effects model with the assumption that 'subject factor' was a random effect. p-value threshold of p\<.10|ANOVA|Adjusted for baseline scores; co-variate adjustments did not affect any of the results||||||.08
72366587|NCT01782378|144243870|SUPERIORITY||Mean Difference (Final Values)|0.32|STANDARD_ERROR_OF_MEAN|0.83|<|0.7|TWO_SIDED|||||without adjustment for multiple comparisons Mixed effects model with the assumption that 'subject factor' was a random effect. p-value threshold of p\<.10|ANOVA|Adjusted for baseline scores; co-variate adjustments did not affect any of the results.||||||<0.7
72366588|NCT01782378|144243871|SUPERIORITY||Mean Difference (Final Values)|0.36|STANDARD_ERROR_OF_MEAN|0.5|<|0.48|TWO_SIDED|||||without adjustment for multiple comparisons Mixed effects model with the assumption that 'subject factor' was a random effect. p-value threshold of p\<.10|ANOVA|Adjusted for baseline scores; co-variate adjustments did not affect any of the results||||||<0.48
72366589|NCT01782378|144243872|SUPERIORITY||Mean Difference (Final Values)|-0.32|STANDARD_ERROR_OF_MEAN|0.16|<|0.02|TWO_SIDED|||||without adjustment for multiple comparisons Mixed effects model with the assumption that 'subject factor' was a random effect. p-value threshold of p\<.10|ANOVA|Adjusted for baseline scores; co-variate adjustments did not affect any of the results.||||||<0.02
72366590|NCT01782378|144243873|SUPERIORITY||Mean Difference (Final Values)|0.174|STANDARD_ERROR_OF_MEAN|0.19|<|0.36|TWO_SIDED|||||without adjustment for multiple comparisons Mixed effects model with the assumption that 'subject factor' was a random effect. p-value threshold of p\<.10|ANOVA|Adjusted for baseline scores; co-variate adjustments did not affect any of the results.||||||<0.36
72366591|NCT01782378|144243874|SUPERIORITY||Mean Difference (Final Values)|-0.21|STANDARD_ERROR_OF_MEAN|0.88|<|0.82|TWO_SIDED|||||without adjustment for multiple comparisons Mixed effects model with the assumption that 'subject factor' was a random effect. p-value threshold of p\<.10|ANOVA|Adjusted for baseline scores; co-variate adjustments did not affect any of the results.||||||<0.82
72366592|NCT01782378|144243875|SUPERIORITY||Mean Difference (Final Values)|1.12|STANDARD_ERROR_OF_MEAN|0.84|<|0.2|TWO_SIDED|||||without adjustment for multiple comparisons Mixed effects model with the assumption that 'subject factor' was a random effect. p-value threshold of p\<.10|ANOVA|Adjusted for baseline scores; co-variate adjustments did not affect any of the results.||||||<0.2
72366593|NCT01782378|144243876|SUPERIORITY||Mean Difference (Final Values)|-0.32|STANDARD_ERROR_OF_MEAN|0.86|<|0.71|TWO_SIDED|||||without adjustment for multiple comparisons Mixed effects model with the assumption that 'subject factor' was a random effect. p-value threshold of p\<.10|ANOVA|Adjusted for baseline scores; co-variate adjustments did not affect any of the results||||||<0.71
72366594|NCT01782378|144243877|SUPERIORITY||Mean Difference (Final Values)|0.14|STANDARD_ERROR_OF_MEAN|0.73|<|0.85|TWO_SIDED|||||without adjustment for multiple comparisons Mixed effects model with the assumption that 'subject factor' was a random effect. p-value threshold of p\<.10|ANOVA|Adjusted for baseline scores; co-variate adjustments did not affect any of the results.||||||<0.85
72366595|NCT01782378|144243878|SUPERIORITY||Mean Difference (Final Values)|-0.73|STANDARD_ERROR_OF_MEAN|0.94|<|0.44|TWO_SIDED|||||without adjustment for multiple comparisons Mixed effects model with the assumption that 'subject factor' was a random effect. p-value threshold of p\<.10|ANOVA|Adjusted for baseline scores; co-variate adjustments did not affect any of the results.||||||<0.44
72366596|NCT00942604|144243887|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||Cochran-Mantel-Haenszel|||||||0.001
72366597|NCT00942604|144243888|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||Cochran-Mantel-Haenszel|||||||0.001
72366598|NCT00999102|144243910|SUPERIORITY||Mean Difference (Final Values)|0.5||||0.67|TWO_SIDED|95.0|-1.86|2.86|||t-test, 2 sided|Paired t-test was performed since each participant received both interventions in a crossover design.|Direction of Comparison: Mean Global Fatigue Score for Nebivolol 5 mg minus Mean Global Fatigue Score for Metoprolol 50 mg.|The null hypothesis is that there is no difference in the Global Fatigue Score after 4 weeks of Nebivolol 5 mg (lower dose) vs. 4 weeks of Metoprolol 50 mg (lower dose).||2.86|-1.86|0.67
72366599|NCT00999102|144243910|SUPERIORITY||Mean Difference (Final Values)|0.7||||0.72|TWO_SIDED|95.0|-3.17|4.55|||t-test, 2 sided|Paired t-test was performed since each participant received both interventions in a crossover design.|Direction of Comparison: Mean Global Fatigue Score for Nebivolol 10 mg minus Mean Global Fatigue Score for Metoprolol 100 mg.|The null hypothesis is that there is no difference in the Global Fatigue Score after 4 weeks of Nebivolol 10 mg (higher dose) vs. 4 weeks of Metoprolol 100 mg (higher dose).||4.55|-3.17|0.72
72366600|NCT00999102|144243911|SUPERIORITY||Mean Difference (Final Values)|-7.03||||0.89|TWO_SIDED|95.0|-108.99|94.92|||t-test, 2 sided|Paired t-test was performed since each participant received both interventions in a crossover design.|Direction of Comparison: Mean Treadmill Exercise Time for Nebivolol 5 mg minus Mean Treadmill Exercise Time for Metoprolol 50 mg.|The null hypothesis is that there is no difference in Treadmill Exercise Time after 4 weeks of Nebivolol 5 mg (lower dose) vs. 4 weeks of Metoprolol 50 mg (lower dose).||94.92|-108.99|0.89
72366601|NCT00999102|144243911|SUPERIORITY||Mean Difference (Final Values)|-25.9||||0.43|TWO_SIDED|95.0|-91.55|39.75|||t-test, 2 sided|Paired t-test was performed since each participant received both interventions in a crossover design.|Direction of Comparison: Mean Treadmill Exercise Time for Nebivolol 10 mg minus Mean Treadmill Exercise Time for Metoprolol 100 mg.|The null hypothesis is that there is no difference in Treadmill Exercise Time after 4 weeks of Nebivolol 10 mg (higher dose) vs. 4 weeks of Metoprolol 100 mg (higher dose).||39.75|-91.55|0.43
72366602|NCT02839200|144243924|OTHER||||||<|0.001|||||||Multiple Comparison Procedure-Model|||"Multiple Comparison Procedure-Modeling (MCP-Mod) was used to assess a dose-response across placebo and all ACT-541468 doses. The null hypothesis of no dose-response was rejected if at least one of the six Multiple Contrasts Tests (MCTs) had a multiplicity adjusted p-value \<0.05. The analysis was performed using the R-package DoseFinding (Bornkamp B, Pinheiro J, Bretz F. Planning and analyzing dose finding experiments. 2016. Available from: cranrprojects.org/web/packages/DoseFinding.)"||||<0.001
72366603|NCT02839200|144243924|OTHER||LS mean difference|-7.0|STANDARD_ERROR_OF_MEAN|5.95||0.241|TWO_SIDED|95.0|-18.7|4.7|||ANCOVA||Parameter Dispersion Type and Dispersion Value: Standard error of the LS mean|||4.7|-18.7|0.241
72366604|NCT02839200|144243924|OTHER||LS Mean difference|-10.8|STANDARD_ERROR_OF_MEAN|6.0||0.072|TWO_SIDED|95.0|-22.6|1.0|||ANCOVA||Parameter Dispersion Type and Dispersion Value: Standard error of the LS mean|||1|-22.6|0.072
72366605|NCT02839200|144243924|OTHER||LS Mean difference|-16.2|STANDARD_ERROR_OF_MEAN|5.95||0.007|TWO_SIDED|95.0|-27.9|-4.5|||ANCOVA||Parameter Dispersion Type and Dispersion Value: Standard error of the LS mean|||-4.5|-27.9|0.007
72366606|NCT02839200|144243924|OTHER||LS Mean difference|-25.6|STANDARD_ERROR_OF_MEAN|5.92|<|0.001|TWO_SIDED|95.0|-37.3|-13.9|||ANCOVA||Parameter Dispersion Type and Dispersion Value: Standard error of the LS mean|||-13.9|-37.3|< 0.001
72366607|NCT02839200|144243924|OTHER||LS Mean difference|-8.5|STANDARD_ERROR_OF_MEAN|5.97||0.155|TWO_SIDED|95.0|-20.4|3.3|||ANCOVA||Parameter Dispersion Type and Dispersion Value: Standard error of the LS mean|||3.3|-20.4|0.155
72366608|NCT01094119|144243936|SUPERIORITY|||||||0.0069|||||||Regression, Logistic|||||||0.0069
72366609|NCT02205736|144243940|SUPERIORITY|||||||0.8084||||||Each of the 25 co-primary objectives were tested at the 2-sided, Bonferroni-corrected alpha=0.002 significance level to preserve an overall type I error rate of 5%.|McNemar|||Patients gave True/False responses to Question 1 at Baseline and Post-Intervention; the True/False responses were mapped to being correct or incorrect. The null hypothesis was that the intervention had no effect on breast health, or that the probability of answering incorrectly on the Baseline questionnaire and correctly on the Post-Intervention questionnaire was equal to the probability of answering correctly on the Baseline questionnaire and incorrectly on the Post-Intervention questionnaire.||||0.8084
72366610|NCT02205736|144243940|SUPERIORITY||||||<|0.0001||||||Each of the 25 co-primary objectives were tested at the 2-sided, Bonferroni-corrected alpha=0.002 significance level to preserve an overall type I error rate of 5%.|McNemar|||Patients gave True/False responses to Question 2 at Baseline and Post-Intervention; the True/False responses were mapped to being correct or incorrect. The null hypothesis was that the intervention had no effect on breast health, or that the probability of answering incorrectly on the Baseline questionnaire and correctly on the Post-Intervention questionnaire was equal to the probability of answering correctly on the Baseline questionnaire and incorrectly on the Post-Intervention questionnaire.||||<.0001
72366611|NCT02205736|144243940|SUPERIORITY|||||||0.0036||||||Each of the 25 co-primary objectives were tested at the 2-sided, Bonferroni-corrected alpha=0.002 significance level to preserve an overall type I error rate of 5%.|McNemar|||Patients gave True/False responses to Question 3 at Baseline and Post-Intervention; the True/False responses were mapped to being correct or incorrect. The null hypothesis was that the intervention had no effect on breast health, or that the probability of answering incorrectly on the Baseline questionnaire and correctly on the Post-Intervention questionnaire was equal to the probability of answering correctly on the Baseline questionnaire and incorrectly on the Post-Intervention questionnaire.||||0.0036
72366612|NCT02205736|144243940|SUPERIORITY|||||||0.0033||||||Each of the 25 co-primary objectives were tested at the 2-sided, Bonferroni-corrected alpha=0.002 significance level to preserve an overall type I error rate of 5%.|McNemar|||Patients gave True/False responses to Question 4 at Baseline and Post-Intervention; the True/False responses were mapped to being correct or incorrect. The null hypothesis was that the intervention had no effect on breast health, or that the probability of answering incorrectly on the Baseline questionnaire and correctly on the Post-Intervention questionnaire was equal to the probability of answering correctly on the Baseline questionnaire and incorrectly on the Post-Intervention questionnaire.||||0.0033
72366613|NCT02205736|144243940|SUPERIORITY||||||<|0.0001||||||Each of the 25 co-primary objectives were tested at the 2-sided, Bonferroni-corrected alpha=0.002 significance level to preserve an overall type I error rate of 5%.|McNemar|||Patients gave True/False responses to Question 5 at Baseline and Post-Intervention; the True/False responses were mapped to being correct or incorrect. The null hypothesis was that the intervention had no effect on breast health, or that the probability of answering incorrectly on the Baseline questionnaire and correctly on the Post-Intervention questionnaire was equal to the probability of answering correctly on the Baseline questionnaire and incorrectly on the Post-Intervention questionnaire.||||<.0001
72366614|NCT02205736|144243940|SUPERIORITY||||||<|0.0001||||||Each of the 25 co-primary objectives were tested at the 2-sided, Bonferroni-corrected alpha=0.002 significance level to preserve an overall type I error rate of 5%.|McNemar|||Patients gave True/False responses to Question 6 at Baseline and Post-Intervention; the True/False responses were mapped to being correct or incorrect. The null hypothesis was that the intervention had no effect on breast health, or that the probability of answering incorrectly on the Baseline questionnaire and correctly on the Post-Intervention questionnaire was equal to the probability of answering correctly on the Baseline questionnaire and incorrectly on the Post-Intervention questionnaire.||||<.0001
72366615|NCT02205736|144243940|SUPERIORITY||||||<|0.0001||||||Each of the 25 co-primary objectives were tested at the 2-sided, Bonferroni-corrected alpha=0.002 significance level to preserve an overall type I error rate of 5%.|McNemar|||Patients gave True/False responses to Question 7 at Baseline and Post-Intervention; the True/False responses were mapped to being correct or incorrect. The null hypothesis was that the intervention had no effect on breast health, or that the probability of answering incorrectly on the Baseline questionnaire and correctly on the Post-Intervention questionnaire was equal to the probability of answering correctly on the Baseline questionnaire and incorrectly on the Post-Intervention questionnaire.||||<.0001
72366616|NCT02205736|144243940|SUPERIORITY||||||<|0.0001||||||Each of the 25 co-primary objectives were tested at the 2-sided, Bonferroni-corrected alpha=0.002 significance level to preserve an overall type I error rate of 5%.|McNemar|||Patients gave True/False responses to Question 8 at Baseline and Post-Intervention; the True/False responses were mapped to being correct or incorrect. The null hypothesis was that the intervention had no effect on breast health, or that the probability of answering incorrectly on the Baseline questionnaire and correctly on the Post-Intervention questionnaire was equal to the probability of answering correctly on the Baseline questionnaire and incorrectly on the Post-Intervention questionnaire.||||<.0001
72366617|NCT02205736|144243940|SUPERIORITY||||||<|0.0001||||||Each of the 25 co-primary objectives were tested at the 2-sided, Bonferroni-corrected alpha=0.002 significance level to preserve an overall type I error rate of 5%.|McNemar|||Patients gave True/False responses to Question 9 at Baseline and Post-Intervention; the True/False responses were mapped to being correct or incorrect. The null hypothesis was that the intervention had no effect on breast health, or that the probability of answering incorrectly on the Baseline questionnaire and correctly on the Post-Intervention questionnaire was equal to the probability of answering correctly on the Baseline questionnaire and incorrectly on the Post-Intervention questionnaire.||||<.0001
72368811|NCT02637037|144247320|NON_INFERIORITY_OR_EQUIVALENCE|If the 90% CIs for both dapagliflozin and metformin geometric mean ratio of AUC is entirely contained within an 80.00% to 125.00% interval, it will be concluded the 2 manufacturing sites are bioequivalent.|Ratios of geometric means|1.03|||||TWO_SIDED|90.0|0.97|1.09||||||Metformin: Statistical Assessment of Bioequivalence for Metformin following administration Dapagliflozin/Metformin XR 10/1000 mg for Treatment E and F.||1.09|0.97|
72366618|NCT02205736|144243940|SUPERIORITY||||||<|0.0001||||||Each of the 25 co-primary objectives were tested at the 2-sided, Bonferroni-corrected alpha=0.002 significance level to preserve an overall type I error rate of 5%.|McNemar|||Patients gave True/False responses to Question 10 at Baseline and Post-Intervention; the True/False responses were mapped to being correct or incorrect. The null hypothesis was that the intervention had no effect on breast health, or that the probability of answering incorrectly on the Baseline questionnaire and correctly on the Post-Intervention questionnaire was equal to the probability of answering correctly on the Baseline questionnaire and incorrectly on the Post-Intervention questionnaire.||||<.0001
72366619|NCT02205736|144243940|SUPERIORITY||||||<|0.0001||||||Each of the 25 co-primary objectives were tested at the 2-sided, Bonferroni-corrected alpha=0.002 significance level to preserve an overall type I error rate of 5%.|McNemar|||Patients gave True/False responses to Question 11 at Baseline and Post-Intervention; the True/False responses were mapped to being correct or incorrect. The null hypothesis was that the intervention had no effect on breast health, or that the probability of answering incorrectly on the Baseline questionnaire and correctly on the Post-Intervention questionnaire was equal to the probability of answering correctly on the Baseline questionnaire and incorrectly on the Post-Intervention questionnaire.||||<.0001
72366620|NCT02205736|144243940|SUPERIORITY|||||||0.0124||||||Each of the 25 co-primary objectives were tested at the 2-sided, Bonferroni-corrected alpha=0.002 significance level to preserve an overall type I error rate of 5%.|McNemar|||Patients gave True/False responses to Question 12 at Baseline and Post-Intervention; the True/False responses were mapped to being correct or incorrect. The null hypothesis was that the intervention had no effect on breast health, or that the probability of answering incorrectly on the Baseline questionnaire and correctly on the Post-Intervention questionnaire was equal to the probability of answering correctly on the Baseline questionnaire and incorrectly on the Post-Intervention questionnaire.||||0.0124
72366621|NCT02205736|144243940|SUPERIORITY||||||<|0.0001||||||Each of the 25 co-primary objectives were tested at the 2-sided, Bonferroni-corrected alpha=0.002 significance level to preserve an overall type I error rate of 5%.|McNemar|||Patients gave True/False responses to Question 13 at Baseline and Post-Intervention; the True/False responses were mapped to being correct or incorrect. The null hypothesis was that the intervention had no effect on breast health, or that the probability of answering incorrectly on the Baseline questionnaire and correctly on the Post-Intervention questionnaire was equal to the probability of answering correctly on the Baseline questionnaire and incorrectly on the Post-Intervention questionnaire.||||<.0001
72366622|NCT02205736|144243940|SUPERIORITY|||||||0.0588||||||Each of the 25 co-primary objectives were tested at the 2-sided, Bonferroni-corrected alpha=0.002 significance level to preserve an overall type I error rate of 5%.|McNemar|||Patients gave True/False responses to Question 14 at Baseline and Post-Intervention; the True/False responses were mapped to being correct or incorrect. The null hypothesis was that the intervention had no effect on breast health, or that the probability of answering incorrectly on the Baseline questionnaire and correctly on the Post-Intervention questionnaire was equal to the probability of answering correctly on the Baseline questionnaire and incorrectly on the Post-Intervention questionnaire.||||0.0588
72366623|NCT02205736|144243940|SUPERIORITY|||||||0.0143||||||Each of the 25 co-primary objectives were tested at the 2-sided, Bonferroni-corrected alpha=0.002 significance level to preserve an overall type I error rate of 5%.|McNemar|||Patients gave True/False responses to Question 15 at Baseline and Post-Intervention; the True/False responses were mapped to being correct or incorrect. The null hypothesis was that the intervention had no effect on breast health, or that the probability of answering incorrectly on the Baseline questionnaire and correctly on the Post-Intervention questionnaire was equal to the probability of answering correctly on the Baseline questionnaire and incorrectly on the Post-Intervention questionnaire.||||0.0143
72366624|NCT02205736|144243940|SUPERIORITY|||||||0.1025||||||Each of the 25 co-primary objectives were tested at the 2-sided, Bonferroni-corrected alpha=0.002 significance level to preserve an overall type I error rate of 5%.|McNemar|||Patients gave True/False responses to Question 16 at Baseline and Post-Intervention; the True/False responses were mapped to being correct or incorrect. The null hypothesis was that the intervention had no effect on breast health, or that the probability of answering incorrectly on the Baseline questionnaire and correctly on the Post-Intervention questionnaire was equal to the probability of answering correctly on the Baseline questionnaire and incorrectly on the Post-Intervention questionnaire.||||0.1025
72366625|NCT02205736|144243940|SUPERIORITY|||||||0.0001||||||Each of the 25 co-primary objectives were tested at the 2-sided, Bonferroni-corrected alpha=0.002 significance level to preserve an overall type I error rate of 5%.|McNemar|||Patients gave True/False responses to Question 17 at Baseline and Post-Intervention; the True/False responses were mapped to being correct or incorrect. The null hypothesis was that the intervention had no effect on breast health, or that the probability of answering incorrectly on the Baseline questionnaire and correctly on the Post-Intervention questionnaire was equal to the probability of answering correctly on the Baseline questionnaire and incorrectly on the Post-Intervention questionnaire.||||0.0001
72366626|NCT02205736|144243940|SUPERIORITY|||||||0.1138||||||Each of the 25 co-primary objectives were tested at the 2-sided, Bonferroni-corrected alpha=0.002 significance level to preserve an overall type I error rate of 5%.|McNemar|||Patients gave True/False responses to Question 18 at Baseline and Post-Intervention; the True/False responses were mapped to being correct or incorrect. The null hypothesis was that the intervention had no effect on breast health, or that the probability of answering incorrectly on the Baseline questionnaire and correctly on the Post-Intervention questionnaire was equal to the probability of answering correctly on the Baseline questionnaire and incorrectly on the Post-Intervention questionnaire.||||0.1138
72366627|NCT02205736|144243940|SUPERIORITY|||||||0.0011||||||Each of the 25 co-primary objectives were tested at the 2-sided, Bonferroni-corrected alpha=0.002 significance level to preserve an overall type I error rate of 5%.|McNemar|||Patients gave True/False responses to Question 19 at Baseline and Post-Intervention; the True/False responses were mapped to being correct or incorrect. The null hypothesis was that the intervention had no effect on breast health, or that the probability of answering incorrectly on the Baseline questionnaire and correctly on the Post-Intervention questionnaire was equal to the probability of answering correctly on the Baseline questionnaire and incorrectly on the Post-Intervention questionnaire.||||0.0011
72366628|NCT02205736|144243940|SUPERIORITY||||||<|0.0001||||||Each of the 25 co-primary objectives were tested at the 2-sided, Bonferroni-corrected alpha=0.002 significance level to preserve an overall type I error rate of 5%.|McNemar|||Patients gave True/False responses to Question 20 at Baseline and Post-Intervention; the True/False responses were mapped to being correct or incorrect. The null hypothesis was that the intervention had no effect on breast health, or that the probability of answering incorrectly on the Baseline questionnaire and correctly on the Post-Intervention questionnaire was equal to the probability of answering correctly on the Baseline questionnaire and incorrectly on the Post-Intervention questionnaire.||||<.0001
72366629|NCT02205736|144243940|SUPERIORITY|||||||0.0522||||||Each of the 25 co-primary objectives were tested at the 2-sided, Bonferroni-corrected alpha=0.002 significance level to preserve an overall type I error rate of 5%.|McNemar|||Patients gave True/False responses to Question 21 at Baseline and Post-Intervention; the True/False responses were mapped to being correct or incorrect. The null hypothesis was that the intervention had no effect on breast health, or that the probability of answering incorrectly on the Baseline questionnaire and correctly on the Post-Intervention questionnaire was equal to the probability of answering correctly on the Baseline questionnaire and incorrectly on the Post-Intervention questionnaire.||||0.0522
72366630|NCT02205736|144243940|SUPERIORITY|||||||0.8185||||||Each of the 25 co-primary objectives were tested at the 2-sided, Bonferroni-corrected alpha=0.002 significance level to preserve an overall type I error rate of 5%.|McNemar|||Patients gave True/False responses to Question 22 at Baseline and Post-Intervention; the True/False responses were mapped to being correct or incorrect. The null hypothesis was that the intervention had no effect on breast health, or that the probability of answering incorrectly on the Baseline questionnaire and correctly on the Post-Intervention questionnaire was equal to the probability of answering correctly on the Baseline questionnaire and incorrectly on the Post-Intervention questionnaire.||||0.8185
72366631|NCT02205736|144243940|SUPERIORITY|||||||0.0005||||||Each of the 25 co-primary objectives were tested at the 2-sided, Bonferroni-corrected alpha=0.002 significance level to preserve an overall type I error rate of 5%.|McNemar|||Patients gave True/False responses to Question 24 at Baseline and Post-Intervention; the True/False responses were mapped to being correct or incorrect. The null hypothesis was that the intervention had no effect on breast health, or that the probability of answering incorrectly on the Baseline questionnaire and correctly on the Post-Intervention questionnaire was equal to the probability of answering correctly on the Baseline questionnaire and incorrectly on the Post-Intervention questionnaire.||||0.0005
72366632|NCT02205736|144243940|SUPERIORITY||||||<|0.0001||||||Each of the 25 co-primary objectives were tested at the 2-sided, Bonferroni-corrected alpha=0.002 significance level to preserve an overall type I error rate of 5%.|McNemar|||Subjects recorded True/False answers to Q25 at Baseline and Post-Intervention; the True/False responses were mapped to being correct or incorrect. The contingency table of 329 responses to Q25 displayed the following: N=260 Correct at Baseline and Correct at Post-Intervention (79.0%), N=7 Correct at Baseline and Incorrect at Post-Intervention (2.1%), N=49 Incorrect at Baseline and Correct at Post-Intervention (14.9%), N=13 Incorrect at Baseline and Incorrect at Post-Intervention (4.0%).||||<.0001
72366633|NCT02205736|144243941|SUPERIORITY|||||||0.2482||||||Each of the 25 co-secondary objectives were tested at the 2-sided, Bonferroni-corrected alpha=0.002 significance level to preserve an overall type I error rate of 5%.|McNemar|||Patients gave True/False responses to Question 1 at Baseline and 3-Month Contact; the True/False responses were mapped to being correct or incorrect. The null hypothesis was that the intervention had no effect on breast health, or that the probability of answering incorrectly on the Baseline questionnaire and correctly on the 3-Month Contact questionnaire was equal to the probability of answering correctly on the Baseline questionnaire and incorrectly on the 3-Month Contact questionnaire.||||0.2482
72366634|NCT02205736|144243941|SUPERIORITY||||||<|0.0001||||||Each of the 25 co-secondary objectives were tested at the 2-sided, Bonferroni-corrected alpha=0.002 significance level to preserve an overall type I error rate of 5%.|McNemar|||Patients gave True/False responses to Question 2 at Baseline and 3-Month Contact; the True/False responses were mapped to being correct or incorrect. The null hypothesis was that the intervention had no effect on breast health, or that the probability of answering incorrectly on the Baseline questionnaire and correctly on the 3-Month Contact questionnaire was equal to the probability of answering correctly on the Baseline questionnaire and incorrectly on the 3-Month Contact questionnaire.||||<.0001
72366635|NCT02205736|144243941|SUPERIORITY|||||||0.005||||||Each of the 25 co-secondary objectives were tested at the 2-sided, Bonferroni-corrected alpha=0.002 significance level to preserve an overall type I error rate of 5%.|McNemar|||Patients gave True/False responses to Question 3 at Baseline and 3-Month Contact; the True/False responses were mapped to being correct or incorrect. The null hypothesis was that the intervention had no effect on breast health, or that the probability of answering incorrectly on the Baseline questionnaire and correctly on the 3-Month Contact questionnaire was equal to the probability of answering correctly on the Baseline questionnaire and incorrectly on the 3-Month Contact questionnaire.||||0.0050
72366636|NCT02205736|144243941|SUPERIORITY|||||||0.0423||||||Each of the 25 co-secondary objectives were tested at the 2-sided, Bonferroni-corrected alpha=0.002 significance level to preserve an overall type I error rate of 5%.|McNemar|||Patients gave True/False responses to Question 4 at Baseline and 3-Month Contact; the True/False responses were mapped to being correct or incorrect. The null hypothesis was that the intervention had no effect on breast health, or that the probability of answering incorrectly on the Baseline questionnaire and correctly on the 3-Month Contact questionnaire was equal to the probability of answering correctly on the Baseline questionnaire and incorrectly on the 3-Month Contact questionnaire.||||0.0423
72366637|NCT02205736|144243941|SUPERIORITY||||||<|0.0001||||||Each of the 25 co-secondary objectives were tested at the 2-sided, Bonferroni-corrected alpha=0.002 significance level to preserve an overall type I error rate of 5%.|McNemar|||Patients gave True/False responses to Question 5 at Baseline and 3-Month Contact; the True/False responses were mapped to being correct or incorrect. The null hypothesis was that the intervention had no effect on breast health, or that the probability of answering incorrectly on the Baseline questionnaire and correctly on the 3-Month Contact questionnaire was equal to the probability of answering correctly on the Baseline questionnaire and incorrectly on the 3-Month Contact questionnaire.||||<.0001
72366638|NCT02205736|144243941|SUPERIORITY||||||<|0.0001||||||Each of the 25 co-secondary objectives were tested at the 2-sided, Bonferroni-corrected alpha=0.002 significance level to preserve an overall type I error rate of 5%.|McNemar|||Patients gave True/False responses to Question 6 at Baseline and 3-Month Contact; the True/False responses were mapped to being correct or incorrect. The null hypothesis was that the intervention had no effect on breast health, or that the probability of answering incorrectly on the Baseline questionnaire and correctly on the 3-Month Contact questionnaire was equal to the probability of answering correctly on the Baseline questionnaire and incorrectly on the 3-Month Contact questionnaire.||||<.0001
72366639|NCT02205736|144243941|SUPERIORITY||||||<|0.0001||||||Each of the 25 co-secondary objectives were tested at the 2-sided, Bonferroni-corrected alpha=0.002 significance level to preserve an overall type I error rate of 5%.|McNemar|||Patients gave True/False responses to Question 7 at Baseline and 3-Month Contact; the True/False responses were mapped to being correct or incorrect. The null hypothesis was that the intervention had no effect on breast health, or that the probability of answering incorrectly on the Baseline questionnaire and correctly on the 3-Month Contact questionnaire was equal to the probability of answering correctly on the Baseline questionnaire and incorrectly on the 3-Month Contact questionnaire.||||<.0001
72366640|NCT02205736|144243941|SUPERIORITY|||||||0.0002||||||Each of the 25 co-secondary objectives were tested at the 2-sided, Bonferroni-corrected alpha=0.002 significance level to preserve an overall type I error rate of 5%.|McNemar|||Patients gave True/False responses to Question 8 at Baseline and 3-Month Contact; the True/False responses were mapped to being correct or incorrect. The null hypothesis was that the intervention had no effect on breast health, or that the probability of answering incorrectly on the Baseline questionnaire and correctly on the 3-Month Contact questionnaire was equal to the probability of answering correctly on the Baseline questionnaire and incorrectly on the 3-Month Contact questionnaire.||||0.0002
72366641|NCT02205736|144243941|SUPERIORITY|||||||0.7456||||||Each of the 25 co-secondary objectives were tested at the 2-sided, Bonferroni-corrected alpha=0.002 significance level to preserve an overall type I error rate of 5%.|McNemar|||Patients gave True/False responses to Question 9 at Baseline and 3-Month Contact; the True/False responses were mapped to being correct or incorrect. The null hypothesis was that the intervention had no effect on breast health, or that the probability of answering incorrectly on the Baseline questionnaire and correctly on the 3-Month Contact questionnaire was equal to the probability of answering correctly on the Baseline questionnaire and incorrectly on the 3-Month Contact questionnaire.||||0.7456
72366642|NCT02205736|144243941|SUPERIORITY||||||<|0.0001||||||Each of the 25 co-secondary objectives were tested at the 2-sided, Bonferroni-corrected alpha=0.002 significance level to preserve an overall type I error rate of 5%.|McNemar|||Patients gave True/False responses to Question 10 at Baseline and 3-Month Contact; the True/False responses were mapped to being correct or incorrect. The null hypothesis was that the intervention had no effect on breast health, or that the probability of answering incorrectly on the Baseline questionnaire and correctly on the 3-Month Contact questionnaire was equal to the probability of answering correctly on the Baseline questionnaire and incorrectly on the 3-Month Contact questionnaire.||||<.0001
72366643|NCT02205736|144243941|SUPERIORITY|||||||0.0028||||||Each of the 25 co-secondary objectives were tested at the 2-sided, Bonferroni-corrected alpha=0.002 significance level to preserve an overall type I error rate of 5%.|McNemar|||Patients gave True/False responses to Question 11 at Baseline and 3-Month Contact; the True/False responses were mapped to being correct or incorrect. The null hypothesis was that the intervention had no effect on breast health, or that the probability of answering incorrectly on the Baseline questionnaire and correctly on the 3-Month Contact questionnaire was equal to the probability of answering correctly on the Baseline questionnaire and incorrectly on the 3-Month Contact questionnaire.||||0.0028
72366644|NCT02205736|144243941|SUPERIORITY|||||||0.0707||||||Each of the 25 co-secondary objectives were tested at the 2-sided, Bonferroni-corrected alpha=0.002 significance level to preserve an overall type I error rate of 5%.|McNemar|||Patients gave True/False responses to Question 12 at Baseline and 3-Month Contact; the True/False responses were mapped to being correct or incorrect. The null hypothesis was that the intervention had no effect on breast health, or that the probability of answering incorrectly on the Baseline questionnaire and correctly on the 3-Month Contact questionnaire was equal to the probability of answering correctly on the Baseline questionnaire and incorrectly on the 3-Month Contact questionnaire.||||0.0707
72366645|NCT02205736|144243941|SUPERIORITY|||||||0.0026||||||Each of the 25 co-secondary objectives were tested at the 2-sided, Bonferroni-corrected alpha=0.002 significance level to preserve an overall type I error rate of 5%.|McNemar|||Patients gave True/False responses to Question 13 at Baseline and 3-Month Contact; the True/False responses were mapped to being correct or incorrect. The null hypothesis was that the intervention had no effect on breast health, or that the probability of answering incorrectly on the Baseline questionnaire and correctly on the 3-Month Contact questionnaire was equal to the probability of answering correctly on the Baseline questionnaire and incorrectly on the 3-Month Contact questionnaire.||||0.0026
72366646|NCT02205736|144243941|SUPERIORITY|||||||0.1797||||||Each of the 25 co-secondary objectives were tested at the 2-sided, Bonferroni-corrected alpha=0.002 significance level to preserve an overall type I error rate of 5%.|McNemar|||Patients gave True/False responses to Question 14 at Baseline and 3-Month Contact; the True/False responses were mapped to being correct or incorrect. The null hypothesis was that the intervention had no effect on breast health, or that the probability of answering incorrectly on the Baseline questionnaire and correctly on the 3-Month Contact questionnaire was equal to the probability of answering correctly on the Baseline questionnaire and incorrectly on the 3-Month Contact questionnaire.||||0.1797
72366647|NCT02205736|144243941|SUPERIORITY|||||||0.6547||||||Each of the 25 co-secondary objectives were tested at the 2-sided, Bonferroni-corrected alpha=0.002 significance level to preserve an overall type I error rate of 5%.|McNemar|||Patients gave True/False responses to Question 15 at Baseline and 3-Month Contact; the True/False responses were mapped to being correct or incorrect. The null hypothesis was that the intervention had no effect on breast health, or that the probability of answering incorrectly on the Baseline questionnaire and correctly on the 3-Month Contact questionnaire was equal to the probability of answering correctly on the Baseline questionnaire and incorrectly on the 3-Month Contact questionnaire.||||0.6547
72366648|NCT02205736|144243941|SUPERIORITY|||||||0.1797||||||Each of the 25 co-secondary objectives were tested at the 2-sided, Bonferroni-corrected alpha=0.002 significance level to preserve an overall type I error rate of 5%.|McNemar|||Patients gave True/False responses to Question 16 at Baseline and 3-Month Contact; the True/False responses were mapped to being correct or incorrect. The null hypothesis was that the intervention had no effect on breast health, or that the probability of answering incorrectly on the Baseline questionnaire and correctly on the 3-Month Contact questionnaire was equal to the probability of answering correctly on the Baseline questionnaire and incorrectly on the 3-Month Contact questionnaire.||||0.1797
72366649|NCT02205736|144243941|SUPERIORITY|||||||0.285||||||Each of the 25 co-secondary objectives were tested at the 2-sided, Bonferroni-corrected alpha=0.002 significance level to preserve an overall type I error rate of 5%.|McNemar|||Patients gave True/False responses to Question 17 at Baseline and 3-Month Contact; the True/False responses were mapped to being correct or incorrect. The null hypothesis was that the intervention had no effect on breast health, or that the probability of answering incorrectly on the Baseline questionnaire and correctly on the 3-Month Contact questionnaire was equal to the probability of answering correctly on the Baseline questionnaire and incorrectly on the 3-Month Contact questionnaire.||||0.2850
72366650|NCT02205736|144243941|SUPERIORITY|||||||0.0606||||||Each of the 25 co-secondary objectives were tested at the 2-sided, Bonferroni-corrected alpha=0.002 significance level to preserve an overall type I error rate of 5%.|McNemar|||Patients gave True/False responses to Question 18 at Baseline and 3-Month Contact; the True/False responses were mapped to being correct or incorrect. The null hypothesis was that the intervention had no effect on breast health, or that the probability of answering incorrectly on the Baseline questionnaire and correctly on the 3-Month Contact questionnaire was equal to the probability of answering correctly on the Baseline questionnaire and incorrectly on the 3-Month Contact questionnaire.||||0.0606
72366651|NCT02205736|144243941|SUPERIORITY|||||||0.0045||||||Each of the 25 co-secondary objectives were tested at the 2-sided, Bonferroni-corrected alpha=0.002 significance level to preserve an overall type I error rate of 5%.|McNemar|||Patients gave True/False responses to Question 19 at Baseline and 3-Month Contact; the True/False responses were mapped to being correct or incorrect. The null hypothesis was that the intervention had no effect on breast health, or that the probability of answering incorrectly on the Baseline questionnaire and correctly on the 3-Month Contact questionnaire was equal to the probability of answering correctly on the Baseline questionnaire and incorrectly on the 3-Month Contact questionnaire.||||0.0045
72366652|NCT02205736|144243941|SUPERIORITY|||||||0.9068||||||Each of the 25 co-secondary objectives were tested at the 2-sided, Bonferroni-corrected alpha=0.002 significance level to preserve an overall type I error rate of 5%.|McNemar|||Patients gave True/False responses to Question 20 at Baseline and 3-Month Contact; the True/False responses were mapped to being correct or incorrect. The null hypothesis was that the intervention had no effect on breast health, or that the probability of answering incorrectly on the Baseline questionnaire and correctly on the 3-Month Contact questionnaire was equal to the probability of answering correctly on the Baseline questionnaire and incorrectly on the 3-Month Contact questionnaire.||||0.9068
72366653|NCT02205736|144243941|SUPERIORITY|||||||0.4142||||||Each of the 25 co-secondary objectives were tested at the 2-sided, Bonferroni-corrected alpha=0.002 significance level to preserve an overall type I error rate of 5%.|McNemar|||Patients gave True/False responses to Question 21 at Baseline and 3-Month Contact; the True/False responses were mapped to being correct or incorrect. The null hypothesis was that the intervention had no effect on breast health, or that the probability of answering incorrectly on the Baseline questionnaire and correctly on the 3-Month Contact questionnaire was equal to the probability of answering correctly on the Baseline questionnaire and incorrectly on the 3-Month Contact questionnaire.||||0.4142
72366654|NCT02205736|144243941|SUPERIORITY|||||||0.5637||||||Each of the 25 co-secondary objectives were tested at the 2-sided, Bonferroni-corrected alpha=0.002 significance level to preserve an overall type I error rate of 5%.|McNemar|||Patients gave True/False responses to Question 22 at Baseline and 3-Month Contact; the True/False responses were mapped to being correct or incorrect. The null hypothesis was that the intervention had no effect on breast health, or that the probability of answering incorrectly on the Baseline questionnaire and correctly on the 3-Month Contact questionnaire was equal to the probability of answering correctly on the Baseline questionnaire and incorrectly on the 3-Month Contact questionnaire.||||0.5637
72366655|NCT02205736|144243941|SUPERIORITY|||||||0.0002||||||Each of the 25 co-secondary objectives were tested at the 2-sided, Bonferroni-corrected alpha=0.002 significance level to preserve an overall type I error rate of 5%.|McNemar|||Patients gave True/False responses to Question 23 at Baseline and 3-Month Contact; the True/False responses were mapped to being correct or incorrect. The null hypothesis was that the intervention had no effect on breast health, or that the probability of answering incorrectly on the Baseline questionnaire and correctly on the 3-Month Contact questionnaire was equal to the probability of answering correctly on the Baseline questionnaire and incorrectly on the 3-Month Contact questionnaire.||||0.0002
72366656|NCT02205736|144243941|SUPERIORITY|||||||0.0196||||||Each of the 25 co-secondary objectives were tested at the 2-sided, Bonferroni-corrected alpha=0.002 significance level to preserve an overall type I error rate of 5%.|McNemar|||Patients gave True/False responses to Question 24 at Baseline and 3-Month Contact; the True/False responses were mapped to being correct or incorrect. The null hypothesis was that the intervention had no effect on breast health, or that the probability of answering incorrectly on the Baseline questionnaire and correctly on the 3-Month Contact questionnaire was equal to the probability of answering correctly on the Baseline questionnaire and incorrectly on the 3-Month Contact questionnaire.||||0.0196
72366657|NCT02205736|144243941|SUPERIORITY||||||<|0.0001||||||This outcome measure for Q25 was tested at the 2-sided, Bonferroni-corrected alpha=0.002 significance level to preserve an overall type I error rate of 5% in the analyses of 25 questions.|McNemar|||Patients gave True/False responses to Question 25 at Baseline and 3-Month Contact; the True/False responses were mapped to being correct or incorrect. The null hypothesis was that the intervention had no effect on breast health, or that the probability of answering incorrectly on the Baseline questionnaire and correctly on the 3-Month Contact questionnaire was equal to the probability of answering correctly on the Baseline questionnaire and incorrectly on the 3-Month Contact questionnaire.||||<.0001
72366658|NCT04701762|144244002|SUPERIORITY||Odds Ratio (OR)|0.2|||<|0.001|TWO_SIDED|99.32|0.14|0.29|||GLM cumulative logit GEE model|||||0.29|0.14|<0.001
72366659|NCT04701762|144244003|SUPERIORITY||Risk Ratio (RR)|0.06|||<|0.001|TWO_SIDED|99.32|0.03|0.14|||Wilcoxon (Mann-Whitney)|||||0.14|0.03|<0.001
72366660|NCT04701762|144244004|SUPERIORITY||Risk Ratio (RR)|0.87||||0.53|TWO_SIDED|99.32|0.48|1.58|||GLM log-binomial model (log link)|||||1.58|0.48|0.53
72366661|NCT04701762|144244005|SUPERIORITY||Mean Difference (Final Values)|2.0|||<|0.001|TWO_SIDED|95.0|0.92|3.1|||Mixed Models Analysis|||||3.1|0.92|<0.001
72366662|NCT04701762|144244006|SUPERIORITY||Mean Difference (Final Values)|0.44||||0.27|TWO_SIDED|95.0|-0.34|1.2|||Mixed Models Analysis|||||1.2|-0.34|0.27
72366663|NCT00753506|144244061|SUPERIORITY_OR_OTHER||F|1.59|||>|0.1|TWO_SIDED|95.0|||||ANOVA|||Repeated measures analaysis of variance||||>0.10
72366664|NCT00357552|144244063|NON_INFERIORITY_OR_EQUIVALENCE|Success of the strategy is assessed according to whether the lower bound of the exact 90% confidence interval of this proportion is greater than 65%.|proportion|87.0|||||TWO_SIDED|90.0|81.0|92.0|||confidence interval|Success was determined by whether the lower bound of the 90% exact confidence interval was greater than 65%.|exact confidence interval|The null hypothesis was that LPV/r monotherapy provides at least a 65% short-term virologic response. The target sample size was 120 subjects. Assuming an underlying true 24 week success rate of 76%, this sample size was chosen in order to provide at least 90% power to show that the true 24 week virologic success rate of LPV/r monotherapy in this population is greater than 65%.||92|81|
72366665|NCT02282605|144244093|SUPERIORITY_OR_OTHER|||||||0.792|||||||Fisher Exact|||||||0.792
72366666|NCT02282605|144244093|SUPERIORITY_OR_OTHER|||||||0.887|||||||Fisher Exact|||||||0.887
72366667|NCT02282605|144244094|SUPERIORITY_OR_OTHER|||||||0.0058||||||For timepoint Day 3 (12 hours after last dose)|Fisher Exact|||||||0.0058
72366668|NCT02282605|144244096|SUPERIORITY_OR_OTHER|||||||0.028||||||The adjusted means were compared for the two-day treatment period.|ANCOVA|||||||0.028
72366669|NCT02282605|144244096|SUPERIORITY_OR_OTHER||||||<|0.001||||||The adjusted means were compared for the two-day treatment period to discharge.|ANCOVA|||||||<0.001
72366670|NCT02282605|144244096|SUPERIORITY_OR_OTHER|||||||0.005||||||The adjusted means were compared for the two-day treatment period through to discharge|ANCOVA|||||||0.005
72366671|NCT03584789|144244119|SUPERIORITY||Odds Ratio (OR)|1.29||||0.08|TWO_SIDED|97.5|0.93|1.8|||Mixed Models Analysis|||||1.80|.93|.08
72366672|NCT03584789|144244119|SUPERIORITY||Odds Ratio (OR)|1.24||||0.18|TWO_SIDED|97.5|0.86|1.79|||Mixed Models Analysis|||||1.79|.86|.18
72366673|NCT03584789|144244120|SUPERIORITY||Odds Ratio (OR)|1.37||||0.71|TWO_SIDED|97.5|0.2|9.44|||Mixed Models Analysis|||||9.44|.20|.71
72366674|NCT03584789|144244120|SUPERIORITY||Odds Ratio (OR)|1.53||||0.62|TWO_SIDED|97.5|0.21|11.0|||Mixed Models Analysis|||||11.00|.21|.62
72366675|NCT03584789|144244121|SUPERIORITY||Median Difference (Net)|-0.07||||0.38|TWO_SIDED|95.0|-0.26|0.12|||Mixed Models Analysis|||||.12|-0.26|.38
72366676|NCT03584789|144244121|SUPERIORITY||Median Difference (Net)|-0.03||||0.7|TWO_SIDED|95.0|-0.24|0.17|||Mixed Models Analysis|||||.17|-0.24|.70
72366677|NCT03584789|144244122|SUPERIORITY||Mean Difference (Net)|-0.14||||0.65|TWO_SIDED|95.0|-0.79|0.5|||Mixed Models Analysis|||||.50|-0.79|.65
72366678|NCT03584789|144244122|SUPERIORITY||Mean Difference (Net)|-0.29||||0.41|TWO_SIDED|95.0|-0.99|0.41|||Mixed Models Analysis|||||.41|-0.99|.41
72366679|NCT00602472|144244151|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.62|STANDARD_ERROR_OF_MEAN|0.06|<|0.0001||95.0|-0.73|-0.5|||ANCOVA|||Linagliptin vs. Placebo||-0.50|-0.73|<0.0001
72366680|NCT00602472|144244152|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.49|STANDARD_ERROR_OF_MEAN|0.04|<|0.0001||95.0|-0.56|-0.41|||ANCOVA|||Linagliptin vs. Placebo||-0.41|-0.56|<0.0001
72366681|NCT00602472|144244153|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.68|STANDARD_ERROR_OF_MEAN|0.05|<|0.0001||95.0|-0.78|-0.58|||ANCOVA|||Linagliptin vs. Placebo||-0.58|-0.78|<0.0001
72366682|NCT00602472|144244154|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.69|STANDARD_ERROR_OF_MEAN|0.05|<|0.0001||95.0|-0.8|-0.59|||ANCOVA|||Linagliptin vs. Placebo||-0.59|-0.80|<0.0001
72366683|NCT00602472|144244155|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.7|STANDARD_ERROR_OF_MEAN|2.8|<|0.0001||95.0|-18.1|-7.3|||ANCOVA|||Linagliptin vs. Placebo||-7.3|-18.1|<0.0001
72366684|NCT00602472|144244156|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.8|STANDARD_ERROR_OF_MEAN|2.3|<|0.0001||95.0|-22.4|-13.2|||ANCOVA|||Linagliptin vs. Placebo||-13.2|-22.4|<0.0001
72366685|NCT00602472|144244157|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.7|STANDARD_ERROR_OF_MEAN|2.4|<|0.0001||95.0|-20.3|-11.1|||ANCOVA|||Linagliptin vs. Placebo||-11.1|-20.3|<0.0001
72366686|NCT00602472|144244158|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.1|STANDARD_ERROR_OF_MEAN|2.6|<|0.0001||95.0|-17.2|-7.1|||ANCOVA|||Linagliptin vs. Placebo||-7.1|-17.2|<0.0001
72366687|NCT00602472|144244159|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.51|||<|0.0001||95.0|3.332|9.111|||Regression, Logistic|||"Linagliptin vs. Placebo~The odds-ratio is based on a logistic regression model including baseline HbA1c and previous antidiabetes medication."||9.111|3.332|<0.0001
72366688|NCT00602472|144244161|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.818|||<|0.0001||95.0|1.989|7.327|||Regression, Logistic|||"Linagliptin vs. Placebo~The odds-ratio is based on a logistic regression model including baseline HbA1c and previous antidiabetes medication."||7.327|1.989|<0.0001
72366689|NCT00602472|144244163|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.36|||<|0.0001||95.0|2.474|4.562|||Regression, Logistic|||"Linagliptin vs. Placebo~The odds-ratio is based on a logistic regression model including baseline HbA1c and previous antidiabetes medication."||4.562|2.474|<0.0001
72366690|NCT03038880|144244164|OTHER|The focus of this trial was estimation rather than hypothesis testing.|Mean Difference (Net)|-2.1|||||TWO_SIDED|80.0|-6.8|2.6|||||The difference was calculated as Faricimab Q12W arm minus Ranibizumab Q4W arm.|||2.6|-6.8|
72366691|NCT03038880|144244164|OTHER|The focus of this trial was estimation rather than hypothesis testing.|Mean Difference (Net)|1.1|||||TWO_SIDED|80.0|-3.4|5.5|||||The difference was calculated as Faricimab Q16W arm minus Ranibizumab Q4W arm.|||5.5|-3.4|
72366692|NCT03038880|144244165|OTHER|The focus of this trial was estimation rather than hypothesis testing.|Mean Difference (Net)|-2.09|||||TWO_SIDED|80.0|-6.75|2.56|||||The difference was calculated as Faricimab Q12W arm minus Ranibizumab Q4W arm.|Week 40: Faricimab Q12W vs. Ranibizumab Q4W||2.56|-6.75|
72366693|NCT03038880|144244165|OTHER|The focus of this trial was estimation rather than hypothesis testing.|Mean Difference (Net)|1.05|||||TWO_SIDED|80.0|-3.4|5.49|||||The difference was calculated as Faricimab Q16W arm minus Ranibizumab Q4W arm.|Week 40: Faricimab Q16W vs. Ranibizumab Q4W||5.49|-3.40|
72366694|NCT03038880|144244165|OTHER|The focus of this trial was estimation rather than hypothesis testing.|Mean Difference (Net)|0.49|||||TWO_SIDED|80.0|-4.26|5.25|||||The difference was calculated as Faricimab Q12W arm minus Ranibizumab Q4W arm.|Week 52: Faricimab Q12W vs. Ranibizumab Q4W||5.25|-4.26|
72366695|NCT03038880|144244165|OTHER|The focus of this trial was estimation rather than hypothesis testing.|Mean Difference (Net)|1.83|||||TWO_SIDED|80.0|-2.71|6.37|||||The difference was calculated as Faricimab Q16W arm minus Ranibizumab Q4W arm.|Week 52: Faricimab Q16W vs. Ranibizumab Q4W||6.37|-2.71|
72366696|NCT03038880|144244167|OTHER|The focus of this trial was estimation rather than hypothesis testing.|Difference in Percentage of Participants|4.76|||||TWO_SIDED|80.0|-15.92|25.44|||||The difference was calculated as Faricimab Q12W arm minus Ranibizumab Q4W arm.|Week 40: Faricimab Q12W vs. Ranibizumab Q4W||25.44|-15.92|
72366697|NCT03038880|144244167|OTHER|The focus of this trial was estimation rather than hypothesis testing.|Difference in Percentage of Participants|5.95|||||TWO_SIDED|80.0|-13.62|25.53|||||The difference was calculated as Faricimab Q16W arm minus Ranibizumab Q4W arm.|Week 40: Faricimab Q16W vs. Ranibizumab Q4W||25.53|-13.62|
72366698|NCT03038880|144244167|OTHER|The focus of this trial was estimation rather than hypothesis testing.|Difference in Percentage of Participants|-4.17|||||TWO_SIDED|80.0|-24.52|16.19|||||The difference was calculated as Faricimab Q12W arm minus Ranibizumab Q4W arm.|Week 52: Faricimab Q12W vs. Ranibizumab Q4W||16.19|-24.52|
72366699|NCT03038880|144244167|OTHER|The focus of this trial was estimation rather than hypothesis testing.|Difference in Percentage of Participants|8.93|||||TWO_SIDED|80.0|-10.73|28.59|||||The difference was calculated as Faricimab Q16W arm minus Ranibizumab Q4W arm.|Week 52: Faricimab Q16W vs. Ranibizumab Q4W||28.59|-10.73|
72366700|NCT03038880|144244169|OTHER|The focus of this trial was estimation rather than hypothesis testing.|Difference in Percentage of Participants|-4.76|||||TWO_SIDED|80.0|-10.72|1.19|||||The difference was calculated as Faricimab Q12W arm minus Ranibizumab Q4W arm.|Week 40: Faricimab Q12W vs. Ranibizumab Q4W||1.19|-10.72|
72366701|NCT03038880|144244169|OTHER|The focus of this trial was estimation rather than hypothesis testing.|Difference in Percentage of Participants|-3.57|||||TWO_SIDED|80.0|-8.07|0.92|||||The difference was calculated as Faricimab Q16W arm minus Ranibizumab Q4W arm.|Week 40: Faricimab Q16W vs. Ranibizumab Q4W||0.92|-8.07|
72366702|NCT03038880|144244169|OTHER|The focus of this trial was estimation rather than hypothesis testing.|Difference in Percentage of Participants|0.0|||||||||||||The difference was calculated as Faricimab Q12W arm minus Ranibizumab Q4W arm.|Week 52: Faricimab Q12W vs. Ranibizumab Q4W||||
72366703|NCT03038880|144244169|OTHER|The focus of this trial was estimation rather than hypothesis testing.|Difference in Percentage of Participants|-3.57|||||TWO_SIDED|80.0|-8.07|0.92|||||The difference was calculated as Faricimab Q16W arm minus Ranibizumab Q4W arm.|Week 52: Faricimab Q16W vs. Ranibizumab Q4W||0.92|-8.07|
72366704|NCT03038880|144244170|OTHER|The focus of this trial was estimation rather than hypothesis testing.|Difference in Percentage of Participants|21.9|||||TWO_SIDED|80.0|0.76|43.05|||||The difference was calculated as Faricimab Q12W arm minus Ranibizumab Q4W arm.|Week 40: Faricimab Q12W vs. Ranibizumab Q4W||43.05|0.76|
72366705|NCT03038880|144244170|OTHER|The focus of this trial was estimation rather than hypothesis testing.|Difference in Percentage of Participants|38.57|||||TWO_SIDED|80.0|19.56|57.59|||||The difference was calculated as Faricimab Q16W arm minus Ranibizumab Q4W arm.|Week 40: Faricimab Q16W vs. Ranibizumab Q4W||57.59|19.56|
72366706|NCT03038880|144244170|OTHER|The focus of this trial was estimation rather than hypothesis testing.|Difference in Percentage of Participants|19.64|||||TWO_SIDED|80.0|-1.14|40.43|||||The difference was calculated as Faricimab Q12W arm minus Ranibizumab Q4W arm.|Week 52: Faricimab Q12W vs. Ranibizumab Q4W||40.43|-1.14|
72366707|NCT03038880|144244170|OTHER|The focus of this trial was estimation rather than hypothesis testing.|Difference in Percentage of Participants|33.93|||||TWO_SIDED|80.0|14.95|52.91|||||The difference was calculated as Faricimab Q16W arm minus Ranibizumab Q4W arm.|Week 52: Faricimab Q16W vs. Ranibizumab Q4W||52.91|14.95|
72366708|NCT03038880|144244171|OTHER|The focus of this trial was estimation rather than hypothesis testing.|Difference in Percentage of Participants|0.0|||||||||||||The difference was calculated as Faricimab Q12W arm minus Ranibizumab Q4W arm.|Week 40: Faricimab Q12W vs. Ranibizumab Q4W||||
72366709|NCT03038880|144244171|OTHER|The focus of this trial was estimation rather than hypothesis testing.|Difference in Percentage of Participants|3.57|||||TWO_SIDED|80.0|-0.92|8.07|||||The difference was calculated as Faricimab Q16W arm minus Ranibizumab Q4W arm.|Week 40: Faricimab Q16W vs. Ranibizumab Q4W||8.07|-0.92|
72366710|NCT03038880|144244171|OTHER|The focus of this trial was estimation rather than hypothesis testing.|Difference in Percentage of Participants|4.76|||||TWO_SIDED|80.0|-1.19|10.72|||||The difference was calculated as Faricimab Q12W arm minus Ranibizumab Q4W arm.|Week 52: Faricimab Q12W vs. Ranibizumab Q4W||10.72|-1.19|
72366711|NCT03038880|144244171|OTHER|The focus of this trial was estimation rather than hypothesis testing.|Difference in Percentage of Participants|3.57|||||TWO_SIDED|80.0|-0.92|8.07|||||The difference was calculated as Faricimab Q16W arm minus Ranibizumab Q4W arm.|Week 52: Faricimab Q16W vs. Ranibizumab Q4W||8.07|-0.92|
72366712|NCT03038880|144244172|OTHER|The focus of this trial was estimation rather than hypothesis testing.|Mean Difference (Net)|0.45|||||TWO_SIDED|80.0|-29.81|30.71|||||The difference was calculated as Faricimab Q12W arm minus Ranibizumab Q4W arm.|Week 40: Faricimab Q12W vs. Ranibizumab Q4W||30.71|-29.81|
72366713|NCT03038880|144244172|OTHER|The focus of this trial was estimation rather than hypothesis testing.|Mean Difference (Net)|14.68|||||TWO_SIDED|80.0|-14.29|43.65|||||The difference was calculated as Faricimab Q16W arm minus Ranibizumab Q4W arm.|Week 40: Faricimab Q16W vs. Ranibizumab Q4W||43.65|-14.29|
72366714|NCT03038880|144244172|OTHER|The focus of this trial was estimation rather than hypothesis testing.|Mean Difference (Net)|-4.85|||||TWO_SIDED|80.0|-30.57|20.87|||||The difference was calculated as Faricimab Q12W arm minus Ranibizumab Q4W arm.|Week 52: Faricimab Q12W vs. Ranibizumab Q4W||20.87|-30.57|
72366715|NCT03038880|144244172|OTHER|The focus of this trial was estimation rather than hypothesis testing.|Mean Difference (Net)|1.12|||||TWO_SIDED|80.0|-23.57|25.8|||||The difference was calculated as Faricimab Q16W arm minus Ranibizumab Q4W arm.|Week 52: Faricimab Q16W vs. Ranibizumab Q4W||25.80|-23.57|
72366716|NCT03038880|144244173|OTHER|The focus of this trial was estimation rather than hypothesis testing.|Mean Difference (Net)|-12.23|||||TWO_SIDED|80.0|-36.6|12.15|||||The difference was calculated as Faricimab Q12W arm minus Ranibizumab Q4W arm.|Week 40: Faricimab Q12W vs. Ranibizumab Q4W||12.15|-36.60|
72366717|NCT03038880|144244173|OTHER|The focus of this trial was estimation rather than hypothesis testing.|Mean Difference (Net)|4.98|||||TWO_SIDED|80.0|-18.5|28.45|||||The difference was calculated as Faricimab Q16W arm minus Ranibizumab Q4W arm.|Week 40: Faricimab Q16W vs. Ranibizumab Q4W||28.45|-18.50|
72366718|NCT03038880|144244173|OTHER|The focus of this trial was estimation rather than hypothesis testing.|Mean Difference (Net)|-8.64|||||TWO_SIDED|80.0|-30.42|13.14|||||The difference was calculated as Faricimab Q12W arm minus Ranibizumab Q4W arm.|Week 52: Faricimab Q12W vs. Ranibizumab Q4W||13.14|-30.42|
72366719|NCT03038880|144244173|OTHER|The focus of this trial was estimation rather than hypothesis testing.|Mean Difference (Net)|7.36|||||TWO_SIDED|80.0|-13.65|28.37|||||The difference was calculated as Faricimab Q16W arm minus Ranibizumab Q4W arm.|Week 52: Faricimab Q16W vs. Ranibizumab Q4W||28.37|-13.65|
72366720|NCT02054104|144244231|OTHER|||||||0.36|||||||Mann-Whitney U test|||||||0.36
72366721|NCT03926611|144244239|SUPERIORITY|LOU064 10 mg q.d.|LS Mean|-13.66|STANDARD_ERROR_OF_MEAN|2.334|<|0.0001|TWO_SIDED|90.0|-17.51|-9.81|||Mixed Models Analysis|Treatment contrast in LS mean (Change)||||-9.81|-17.51|<0.0001
72366722|NCT03926611|144244239|SUPERIORITY|LOU064 35 mg q.d.|LS Mean|-13.64|STANDARD_ERROR_OF_MEAN|2.336|<|0.0001|TWO_SIDED|90.0|-17.49|-9.78|||Mixed Models Analysis|Treatment contrast in LS mean (Change)||||-9.78|-17.49|<0.0001
72366723|NCT03926611|144244239|SUPERIORITY|LOU064 100 mg q.d.|LS Mean|-9.21|STANDARD_ERROR_OF_MEAN|2.277|<|0.0001|TWO_SIDED|90.0|-12.97|-5.45|||Mixed Models Analysis|Treatment contrast in LS mean (Change)||||-5.45|-12.97|<0.0001
72366724|NCT03926611|144244239|SUPERIORITY|LOU064 10 mg b.i.d.|LS Mean|-10.55|STANDARD_ERROR_OF_MEAN|2.319|<|0.0001|TWO_SIDED|90.0|-14.38|-6.72|||Mixed Models Analysis|Treatment contrast in LS mean (Change)||||-6.72|-14.38|<0.0001
72366725|NCT03926611|144244239|SUPERIORITY|LOU064 25 mg b.i.d.|LS Mean|-14.58|STANDARD_ERROR_OF_MEAN|2.334|<|0.0001|TWO_SIDED|90.0|-18.43|-10.73|||Mixed Models Analysis|Treatment contrast in LS mean (Change)||||-10.73|-18.43|<0.0001
72366726|NCT03926611|144244239|SUPERIORITY|LOU064 100 mg b.i.d.|LS Mean|-12.62|STANDARD_ERROR_OF_MEAN|2.327|<|0.0001|TWO_SIDED|90.0|-16.45|-8.78|||Mixed Models Analysis|Treatment contrast in LS mean (Change)||||-8.78|-16.45|<0.0001
72366727|NCT03926611|144244240|SUPERIORITY|LOU064 10 mg q.d.|LS Mean|-10.24|STANDARD_ERROR_OF_MEAN|2.71|<|0.0001|TWO_SIDED|90.0|-14.72|-5.77|||Mixed Models Analysis|Treatment contrast in LS mean (Change)||||-5.77|-14.72|<0.0001
72366728|NCT03926611|144244240|SUPERIORITY|LOU064 35 mg q.d.|LS Mean|-10.11|STANDARD_ERROR_OF_MEAN|2.711||0.0001|TWO_SIDED|90.0|-14.58|-5.63|||Mixed Models Analysis|Treatment contrast in LS mean (Change)||||-5.63|-14.58|0.0001
72366729|NCT03926611|144244240|SUPERIORITY|LOU064 100 mg q.d.|LS Mean|-7.4|STANDARD_ERROR_OF_MEAN|2.635||0.0027|TWO_SIDED|90.0|-11.75|-3.05|||Mixed Models Analysis|Treatment contrast in LS mean (Change)||||-3.05|-11.75|0.0027
72366730|NCT03926611|144244240|SUPERIORITY|LOU064 10 mg b.i.d.|LS Mean|-9.8|STANDARD_ERROR_OF_MEAN|2.696||0.0002|TWO_SIDED|90.0|-14.25|-5.35|||Mixed Models Analysis|Treatment contrast in LS mean (Change)||||-5.35|-14.25|0.0002
72366731|NCT03926611|144244240|SUPERIORITY|LOU064 25 mg b.i.d.|LS Mean|-12.35|STANDARD_ERROR_OF_MEAN|2.714|<|0.0001|TWO_SIDED|90.0|-16.82|-7.87|||Mixed Models Analysis|Treatment contrast in LS mean (Change)||||-7.87|-16.82|<0.0001
72366732|NCT03926611|144244240|SUPERIORITY|LOU064 100 mg b.i.d.|LS Mean|-9.52|STANDARD_ERROR_OF_MEAN|2.733||0.0003|TWO_SIDED|90.0|-14.03|-5.01|||Mixed Models Analysis|Treatment contrast in LS mean (Change)||||-5.01|-14.03|0.0003
72366733|NCT00084136|144244259|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.51|||<|0.01|TWO_SIDED|95.0|1.12|2.04||Not adjusted for multiple interim analyses. Peto-Haybittle spending function was used as a basis for calculating the repeated confidence intervals used in interim monitoring.|Log Rank|Log-rank test was stratified by country and screening RNA (\< 100,000 c/mL vs \>= 100,000 copies/mL).|The HR is for ddI+FTC+ATV vs. ZDV/3TC+EFV.|||2.04|1.12|<0.01
72366734|NCT00084136|144244260|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.95|||||TWO_SIDED|95.0|0.72|1.27|||Other||The HR is for TDF/FTC+EFV vs. ZDV/3TC+EFV.|While original study design specified a non-inferiority test, study follow-up stopped early, not due to treatment effect size or futility, but due to slowing accumulation of primary outcome events. Therefore, 2-sided, 95% confidence intervals about the estimated treatment effect (relative effect estimated by a hazard ratio) are provided.||1.27|0.72|
72366735|NCT02230670|144244278|SUPERIORITY||Mean Difference (Final Values)|-0.14|STANDARD_ERROR_OF_MEAN|0.0817||0.091|TWO_SIDED|95.0|-0.302|0.023|||ANCOVA|||Analysis was conducted using an ANCOVA model adjusting for baseline value.||0.023|-0.302|0.091
72366736|NCT02230670|144244278|SUPERIORITY||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.21||0.041|TWO_SIDED|95.0|-0.41|0.01|||ANCOVA|||The analysis was conducted using an ANCOVA model adjusting for baseline value, baseline MELD score, and etiology. The significance was assessed using Type II Sums of Squares from this ANCOVA model.||0.01|-0.41|0.041
72366737|NCT02230670|144244279|SUPERIORITY||Mean Difference (Final Values)|-0.24|STANDARD_ERROR_OF_MEAN|0.333||0.466|TWO_SIDED|95.0|-0.91|0.42|||ANCOVA|||Analysis was conducted using an ANCOVA model adjusting for baseline value.||0.42|-0.91|0.466
72366738|NCT02230670|144244279|SUPERIORITY||Median Difference (Final Values)|-2.19|STANDARD_ERROR_OF_MEAN|1.42||0.003|TWO_SIDED|95.0|-3.61|-0.77|||ANCOVA|calculated from the estimated least square means for the treatment by BL MELD category interaction term.||BL MELD \>= 15 subgroup results (N=19), as analyzed from the adjusted analysis ANCOVA model adjusting for baseline value, baseline MELD score, and etiology.||-0.77|-3.61|0.003
72366739|NCT02230670|144244279|SUPERIORITY||Median Difference (Final Values)|-1.6|STANDARD_ERROR_OF_MEAN|1.46||0.029|TWO_SIDED|95.0|-3.09|-0.17|||ANCOVA|calculated from the estimated least square means for the treatment by etiology interaction term.||NASH Etiology subgroup results (N=20), as analyzed from the adjusted analysis ANCOVA model adjusting for baseline value, baseline MELD score, and etiology.||-0.17|-3.09|0.029
72368812|NCT02637037|144247320|NON_INFERIORITY_OR_EQUIVALENCE|If the 90% CIs for both dapagliflozin and metformin geometric mean ratio of AUC is entirely contained within an 80.00% to 125.00% interval, it will be concluded the 2 manufacturing sites are bioequivalent.|Ratios of Geometric means|1.01|||||TWO_SIDED|90.0|0.95|1.07||||||Metformin: Statistical Assessment of Bioequivalence for Metformin following administration Dapagliflozin/Metformin XR 10/1000 mg for Treatment G and H.||1.07|0.95|
72366740|NCT00836693|144244282|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.9|STANDARD_ERROR_OF_MEAN|0.85|<|0.001|TWO_SIDED|95.0|2.2|5.5||p-value is for Week 12 Change. The null hypothesis concerning tadalafil versus placebo was to be rejected if, and only if, the three primary hypotheses (H01, H02, and H03) were all rejected therefore no adjustments for multiple comparisons were made.|ANCOVA|Change = Endpoint - Baseline.||Model included terms for baseline value of efficacy variable, treatment group, country, and the baseline-by-treatment-group interaction. In any model,if the interaction was not significant (if p≥0.10), then the interaction term was removed and the main effects model was used to calculate the between-treatment-group p-value. All tests were based on type 3 sums of squares.||5.5|2.2|<0.001
72366741|NCT00836693|144244283|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.7|STANDARD_ERROR_OF_MEAN|3.35|<|0.001|TWO_SIDED|95.0|5.1|18.3||p-value is for Week 12 Change. The null hypothesis concerning tadalafil versus placebo was to be rejected if, and only if, the three primary hypotheses (H01, H02, and H03) were all rejected therefore no adjustments for multiple comparisons were made.|ANCOVA|Change = Endpoint - Baseline.||Model included terms for baseline value of efficacy variable, treatment group, country, and the baseline-by-treatment-group interaction. In any model,if the interaction was not significant (if p≥0.10), then the interaction term was removed and the main effects model was used to calculate the between-treatment-group p-value. All tests were based on type 3 sums of squares.||18.3|5.1|<0.001
72366742|NCT00836693|144244284|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|18.0|STANDARD_ERROR_OF_MEAN|4.6|<|0.001|TWO_SIDED|95.0|8.9|27.0||p-value is for Week 12 Change. The null hypothesis concerning tadalafil versus placebo was to be rejected if, and only if, the three primary hypotheses (H01, H02, and H03) were all rejected therefore no adjustments for multiple comparisons were made.|ANCOVA|Change = Endpoint - Baseline.||Model included terms for baseline value of efficacy variable, treatment group, country, and the baseline-by-treatment-group interaction. In any model,if the interaction was not significant (if p≥0.10), then the interaction term was removed and the main effects model was used to calculate the between-treatment-group p-value. All tests were based on type 3 sums of squares.||27.0|8.9|<0.001
72366743|NCT00836693|144244288|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.2|STANDARD_ERROR_OF_MEAN|3.37|<|0.001|TWO_SIDED|95.0|9.5|22.8||P-value is for Week 12 change. For secondary endpoints, all tests of hypotheses (null hypothesis versus the alternative hypothesis) were performed as two-sided tests at the 0.05 significance level (α=0.05) unless otherwise stated.|ANCOVA|Change = Endpoint - Baseline.||The change from baseline to endpoint in morning erection percentages was analyzed with an ANCOVA model including terms for baseline value, treatment group, country, age and the baseline-by-treatment-group interaction. In any model, if the interaction was not significant (at p≥0.10), then the interaction term was removed from the model and the main effects model was used to calculate the between-treatment-group p-value. All tests were based on type 3 sums of squares.||22.8|9.5|<0.001
72366744|NCT00836693|144244289|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|20.0|STANDARD_ERROR_OF_MEAN|3.11|>|0.001|TWO_SIDED|95.0|13.9|26.1||p-value is for Week 12 Change. For secondary endpoints, all tests of hypotheses were performed as two-sided tests at the 0.05 significance level (α=0.05) unless otherwise stated.|ANOVA|||The models included terms for baseline value of the efficacy variable,treatment group,country, and the baseline-by-treatment-group interaction.In any model, if the interaction was not significant (at p≥0.10), then the interaction term was removed from the model and the main effects model was used to calculate the between-treatment-group p-value. All tests were based on type 3 sums of squares.||26.1|13.9|>0.001
72366745|NCT00836693|144244290|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.7|STANDARD_ERROR_OF_MEAN|3.17|<|0.001|TWO_SIDED|95.0|5.5|18.0||p-value is for Total (Change). For secondary endpoints, all tests of hypotheses (null hypothesis versus the alternative hypothesis) were performed as two-sided tests at the 0.05 significance level (α=0.05) unless otherwise stated.|ANCOVA|Change = Endpoint - Baseline.||The model included terms for baseline value of the efficacy variable, treatment group, country, and the baseline-by-treatment-group interaction. In any model, if the interaction was not significant (at p≥0.10), then the interaction term was removed from the model and the main effects model was used to calculate the between-treatment-group p-value. All tests were based on type 3 sums of squares.||18.0|5.5|<0.001
72366746|NCT00836693|144244290|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.2|STANDARD_ERROR_OF_MEAN|3.36|<|0.001|TWO_SIDED|95.0|6.6|19.8||p-value is for Sexual Relationship Domain(Change).For secondary endpoints, all tests of hypotheses (null hypothesis versus the alternative hypothesis) were performed as two-sided tests at the 0.05 significance level (α=0.05) unless otherwise stated.|ANCOVA|Change = Endpoint - Baseline.||The model included terms for baseline value of the efficacy variable, treatment group, country, and the baseline-by-treatment-group interaction. In any model, if the interaction was not significant (at p≥0.10), then the interaction term was removed from the model and the main effects model was used to calculate the between-treatment-group p-value. All tests were based on type 3 sums of squares.||19.8|6.6|<0.001
72366747|NCT00836693|144244290|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.9|STANDARD_ERROR_OF_MEAN|3.34||0.0034|TWO_SIDED|95.0|3.3|16.5||p-value is for Confidence Domain (Change).For secondary endpoints, all tests of hypotheses (null hypothesis versus the alternative hypothesis) were performed as two-sided tests at the 0.05 significance level (α=0.05) unless otherwise stated.|ANCOVA|Change = Endpoint - Baseline.||The model included terms for baseline value of the efficacy variable, treatment group, country, and the baseline-by-treatment-group interaction. In any model, if the interaction was not significant (at p≥0.10), then the interaction term was removed from the model and the main effects model was used to calculate the between-treatment-group p-value. All tests were based on type 3 sums of squares.||16.5|3.3|0.0034
72368813|NCT02637037|144247321|NON_INFERIORITY_OR_EQUIVALENCE|If the 90% CIs for both dapagliflozin and metformin geometric mean ratio of AUC is entirely contained within an 80.00% to 125.00% interval, it will be concluded the 2 manufacturing sites are bioequivalent.|Ratios of Geometric means|0.98|||||TWO_SIDED|90.0|0.93|1.03||||||Dapagliflozin: Statistical Assessment of Bioequivalence for Dapagliflozin following administration Dapagliflozin/Metformin XR 5/500 mg for Treatment A and B.||1.03|0.93|
72366748|NCT00836693|144244290|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.0|STANDARD_ERROR_OF_MEAN|3.52||0.002|TWO_SIDED|95.0|4.1|17.9||p-value is for Self-Esteem Domain (Change).For secondary endpoints, all tests of hypotheses (null hypothesis versus the alternative hypothesis) were performed as two-sided tests at the 0.05 significance level (α=0.05) unless otherwise stated.|ANCOVA|Change = Endpoint - Baseline.||The model included terms for baseline value of the efficacy variable, treatment group, country, and the baseline-by-treatment-group interaction. In any model, if the interaction was not significant (at p≥0.10), then the interaction term was removed from the model and the main effects model was used to calculate the between-treatment-group p-value. All tests were based on type 3 sums of squares.||17.9|4.1|0.0020
72366749|NCT00836693|144244290|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.5|STANDARD_ERROR_OF_MEAN|4.07||0.0653|TWO_SIDED|95.0|-0.5|15.6||p-value is for Overall Relationship Domain(Change).For secondary endpoints, all tests of hypotheses (null hypothesis versus the alternative hypothesis) were performed as two-sided tests at the 0.05 significance level (α=0.05) unless otherwise stated.|ANCOVA|Change = Endpoint - Baseline.||The model included terms for baseline value of the efficacy variable, treatment group, country, and the baseline-by-treatment-group interaction. In any model, if the interaction was not significant (at p≥0.10), then the interaction term was removed from the model and the main effects model was used to calculate the between-treatment-group p-value. All tests were based on type 3 sums of squares.||15.6|-0.5|0.0653
72366750|NCT00836693|144244291|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.3|STANDARD_ERROR_OF_MEAN|0.29|<|0.001|TWO_SIDED|95.0|0.7|1.9||p-value is for Week 12 Change.For secondary endpoints, all tests of hypotheses were performed as two-sided tests at the 0.05 significance level (α=0.05) unless otherwise stated.|ANCOVA|Change = Endpoint - Baseline.||Model included terms for baseline value of efficacy variable, treatment group, country, and the baseline-by-treatment-group interaction. In any model,if the interaction was not significant (if p≥0.10), then the interaction term was removed and the main effects model was used to calculate the between-treatment-group p-value. All tests were based on type 3 sums of squares.||1.9|0.7|<0.001
72366751|NCT00836693|144244292|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.7|STANDARD_ERROR_OF_MEAN|0.25||0.0089|TWO_SIDED|95.0|0.2|1.1||p-value is for Week 12 Change. For secondary endpoints, all tests of hypotheses were performed as two-sided tests at the 0.05 significance level (α=0.05) unless otherwise stated.|ANCOVA|Change = Endpoint - Baseline.||Model included terms for baseline value of efficacy variable, treatment group, country, and the baseline-by-treatment-group interaction. In any model,if the interaction was not significant (if p≥0.10), then the interaction term was removed and the main effects model was used to calculate the between-treatment-group p-value. All tests were based on type 3 sums of squares.||1.1|0.2|0.0089
72366752|NCT00836693|144244293|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.8|STANDARD_ERROR_OF_MEAN|0.37||0.0461|TWO_SIDED|95.0|0.0|1.5||p-value is for Week 12 Change. For secondary endpoints, all tests of hypotheses were performed as two-sided tests at the 0.05 significance level (α=0.05) unless otherwise stated.|ANCOVA|Change = Endpoint - Baseline.||Model included terms for baseline value of efficacy variable, treatment group, country, and the baseline-by-treatment-group interaction. In any model,if the interaction was not significant (if p≥0.10), then the interaction term was removed and the main effects model was used to calculate the between-treatment-group p-value. All tests were based on type 3 sums of squares.||1.5|0.0|0.0461
72366753|NCT00836693|144244294|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.3|STANDARD_ERROR_OF_MEAN|0.3|<|0.001|TWO_SIDED|95.0|0.7|1.9||p-value is for Week 12 Change. For secondary endpoints, all tests of hypotheses were performed as two-sided tests at the 0.05 significance level (α=0.05) unless otherwise stated.|ANCOVA|Change = Endpoint - Baseline.||Model included terms for baseline value of efficacy variable, treatment group, country, and the baseline-by-treatment-group interaction. In any model,if the interaction was not significant (if p≥0.10), then the interaction term was removed and the main effects model was used to calculate the between-treatment-group p-value. All tests were based on type 3 sums of squares.||1.9|0.7|<0.001
72366754|NCT00836693|144244295|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.3|STANDARD_ERROR_OF_MEAN|2.22||0.0047|TWO_SIDED|95.0|2.0|10.7||p-value is for Week 12 Change. For secondary endpoints, all tests of hypotheses were performed as two-sided tests at the 0.05 significance level (α=0.05) unless otherwise stated.|ANCOVA|Baseline = Visit 2; Endpoint = the last non-missing post-baseline value until Visit 5; Change = Endpoint - Baseline.||The model included terms for baseline value of the efficacy variable, treatment group, country, and the baseline-by-treatment-group interaction. In any model, if the interaction was not significant (that is, if p≥0.10), then the interaction term was removed from the model and the main effects model was used to calculate the between-treatment-group p-value. All tests were based on the type 3 sums of squares.||10.7|2.0|0.0047
72366755|NCT00836693|144244296|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|24.5|STANDARD_ERROR_OF_MEAN|4.99|<|0.001|TWO_SIDED|95.0|14.6|34.3||p-value is for Week 12 Change.For secondary endpoints, all tests of hypotheses were performed as two-sided tests at the 0.05 significance level (α=0.05) unless otherwise stated.|ANCOVA|Baseline = Visit 2; Endpoint = the last non-missing post-baseline value until Visit 5; Change = Endpoint - Baseline.||The model included terms for baseline value of the efficacy variable, treatment group, country, and the baseline-by-treatment-group interaction. In any model, if the interaction was not significant (that is, if p≥0.10), then the interaction term was removed from the model and the main effects model was used to calculate the between-treatment-group p-value. All tests were based on the type 3 sums of squares.||34.3|14.6|<0.001
72366756|NCT00836693|144244297|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|23.5|STANDARD_ERROR_OF_MEAN|4.96|<|0.001|TWO_SIDED|95.0|13.7|33.2||p-value is for Week 12 Change.For secondary endpoints, all tests of hypotheses were performed as two-sided tests at the 0.05 significance level (α=0.05) unless otherwise stated.|ANCOVA|Baseline = Visit 2; Endpoint = the last non-missing post-baseline value until Visit 5; Change = Endpoint - Baseline.||The model included terms for baseline value of the efficacy variable, treatment group, country, and the baseline-by-treatment-group interaction. In any model, if the interaction was not significant (that is, if p≥0.10), then the interaction term was removed from the model and the main effects model was used to calculate the between-treatment-group p-value. All tests were based on the type 3 sums of squares.||33.2|13.7|<0.001
72366757|NCT00836693|144244298|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||p-value is for Global Assessment Questions GAQ1. For secondary endpoints, all tests of hypotheses were performed as two-sided tests at the 0.05 significance level (α=0.05) unless otherwise stated.|Wilcoxon (Mann-Whitney)|||Wilcoxon's rank sum test was used to compare responses to GAQs between treatment groups.||||<0.0001
72366758|NCT00836693|144244299|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||p-value is for Global Assessment Question GAQ2.For secondary endpoints, all tests of hypotheses were performed as two-sided tests at the 0.05 significance level (α=0.05) unless otherwise stated.|Wilcoxon (Mann-Whitney)|||Wilcoxon's rank sum test was used to compare responses to GAQs between treatment groups.||||<0.0001
72366759|NCT01750229|144244305|SUPERIORITY|||||||0.002|||||||Mixed Models Analysis|Variables included in the Mixed Model were: baseline VAS back pain score, treatment group, and period.||||||0.002
72366760|NCT01411891|144244312|SUPERIORITY||Risk Ratio (RR)|1.5|||||TWO_SIDED|95.0|0.3|8.4||||||||8.4|0.3|
72366761|NCT01411891|144244313|SUPERIORITY||Risk Ratio (RR)|0.8||||0.65|TWO_SIDED|95.0|0.4|1.6|||Regression, Logistic|||||1.6|0.4|0.65
72366762|NCT02004093|144244315|SUPERIORITY_OR_OTHER|||||||0.3967|||||||Log Rank|||||||0.3967
72366763|NCT02004093|144244315|SUPERIORITY_OR_OTHER|||||||0.4552|||||||Wilcoxon (Mann-Whitney)|||||||0.4552
72366764|NCT02004093|144244315|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.17||||0.3972|TWO_SIDED|80.0|0.92|1.49||p-value resulting from Wald test of null hypothesis that the hazard ratio equals (=) 1|Wald test|||||1.49|0.92|0.3972
72366765|NCT02004093|144244316|SUPERIORITY_OR_OTHER||Difference in Response Rates|6.32||||0.3943|TWO_SIDED|80.0|-3.9|16.6|||Chi-squared|||||16.6|-3.9|0.3943
72366766|NCT02004093|144244316|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.36|||||TWO_SIDED|80.0|0.86|2.17|||||approximate 80% confidence interval (CI) for difference of two rates using Hauck-Anderson method|||2.17|0.86|
72366767|NCT02004093|144244317|SUPERIORITY_OR_OTHER|||||||0.3655|||||||Log Rank|||||||0.3655
72366768|NCT02004093|144244317|SUPERIORITY_OR_OTHER|||||||0.1319|||||||Wilcoxon (Mann-Whitney)|||||||0.1319
72366769|NCT02004093|144244317|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.22||||0.3679|TWO_SIDED|80.0|0.92|1.61|||Wald test|p-value resulting from Wald test of null hypothesis that the hazard ratio=1||||1.61|0.92|0.3679
72366770|NCT02004093|144244320|SUPERIORITY_OR_OTHER|||||||0.8129|||||||Log Rank|||||||0.8129
72366771|NCT02004093|144244320|SUPERIORITY_OR_OTHER|||||||0.692|||||||Wilcoxon (Mann-Whitney)|||||||0.6920
72366772|NCT02004093|144244320|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.04||||0.8137|TWO_SIDED|80.0|0.82|1.32|||Wald test|p-value resulting from Wald test of null hypothesis that the hazard ratio=1||||1.32|0.82|0.8137
72366773|NCT02004093|144244323|SUPERIORITY_OR_OTHER|||||||0.5726|||||||Log Rank|||||||0.5726
72366774|NCT02004093|144244323|SUPERIORITY_OR_OTHER|||||||0.3903|||||||Wilcoxon (Mann-Whitney)|||||||0.3903
72366775|NCT02004093|144244323|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.11||||0.587|TWO_SIDED|80.0|0.87|1.43|||Wald test|p-value resulting from Wald test of null hypothesis that the hazard ratio=1||||1.43|0.87|0.5870
72366776|NCT02004093|144244325|SUPERIORITY_OR_OTHER|||||||0.9261|||||||Log Rank|||||||0.9261
72366777|NCT02004093|144244325|SUPERIORITY_OR_OTHER|||||||0.8591|||||||Wilcoxon (Mann-Whitney)|||||||0.8591
72366778|NCT02004093|144244325|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.02||||0.9262|TWO_SIDED|80.0|0.74|1.41||p-value resulting from Wald test of null hypothesis that the hazard ratio=1|Wald test|||||1.41|0.74|0.9262
72366779|NCT00414596|144244327|SUPERIORITY_OR_OTHER|||||||0.0001|||||||Mixed Models Analysis|The primary pain end-point was assessed by a mixed effect model with time (visit) and as fixed effects and subject as random effect.||"Hypothesis: Patients with chronic low back pain who undergo spinal decompression with a standardized 6-week regimen consisting of 20 treatments with the spinal decompression system would experience \>50% reduction in their verbal score of pain intensity.~Power Analysis: Mean pain scores at time of enrollment were assumed to equal 6 with potential reduction in pain of 50%. To obtain 80% power at an alpha level of 0.05, sample size was estimated as 20 patients."||||.0001
72366780|NCT00297258|144244406|SUPERIORITY_OR_OTHER||percentage of participants|46.0||||0.653||90.0|11.0|47.6|||binomial exact method||The estimated value represents the percentage of participants with a CR, a PR, or SD.|||47.6|11.0|0.653
72366781|NCT00297258|144244406|SUPERIORITY_OR_OTHER||percentage of participants|41.0||||0.003||90.0|28.4|55.5|||binomial exact method||The estimated value represents the percentage of participants with a CR, a PR, or SD.|||55.5|28.4|0.003
72366782|NCT00297258|144244406|SUPERIORITY_OR_OTHER||percentage of participants|49.0|||<|0.001||90.0|34.3|63.2|||binomial exact method||The estimated value represents the percentage of participants with a CR, a PR, or SD.|||63.2|34.3|<0.001
72366783|NCT00297258|144244406|SUPERIORITY_OR_OTHER||percentage of participants|41.0||||0.003||90.0|28.4|55.5|||binomial exact method||The estimated value represents the percentage of participants with a CR, a PR, or SD.|||55.5|28.4|0.003
72366784|NCT02504151|144244425|SUPERIORITY||Mean Difference (Net)|-0.284|STANDARD_ERROR_OF_MEAN|1.01||0.08|TWO_SIDED|95.0|-2.28|1.71|||Mixed Models Analysis|Linear mixed models was used with treatment, time and time\*treatment interaction in the model.|This is the estimated difference between treatment groups (cbd - placebo).|The p value is based on the interaction of treatment and time.||1.71|-2.28|0.08
72366785|NCT02504151|144244426|SUPERIORITY||Mean Difference (Net)|-0.03|STANDARD_ERROR_OF_MEAN|0.05||0.48|TWO_SIDED|95.0|-0.12|0.07|||Mixed Models Analysis||This is the estimated difference between treatment groups (cbd - placebo).|The p value is based on the interaction of treatment and time.||0.07|-0.12|0.48
72366786|NCT02504151|144244427|SUPERIORITY||Mean Difference (Net)|-4.97|STANDARD_ERROR_OF_MEAN|2.47||0.485|TWO_SIDED|95.0|-9.87|-0.06|||Mixed Models Analysis||This is the estimated difference between treatment groups (cbd - placebo).|The p value is based on the interaction of treatment and time.||-0.06|-9.87|0.485
72366787|NCT02504151|144244428|SUPERIORITY||Mean Difference (Net)|4.13|STANDARD_ERROR_OF_MEAN|2.05||0.994|TWO_SIDED|95.0|0.07|8.19|||Mixed Models Analysis||This is the estimated difference between treatment groups (cbd - placebo).|The p value is based on the interaction of treatment and time.||8.19|0.07|0.994
72366788|NCT05038982|144244429|SUPERIORITY||Mean Difference (Net)|78.26|STANDARD_ERROR_OF_MEAN|16.15|<|0.001|TWO_SIDED|95.0|38.09|118.48||Threshold of significance at 0.05.|ANOVA||Percent PP-NRS reduction comparing subject's values at Week 0 to values at Week 12|||118.48|38.09|<0.001
72366789|NCT05038982|144244429|SUPERIORITY||Mean Difference (Net)|53.66|STANDARD_ERROR_OF_MEAN|18.12||0.0142|TWO_SIDED|95.0|8.55|98.76||Threshold of significance at 0.05.|ANOVA||Percent PP-NRS reduction comparing subject's values at Week 0 to values at Week 12|||98.76|8.55|0.0142
72366790|NCT05038982|144244431|SUPERIORITY||Mean Difference (Net)|9.4|STANDARD_ERROR_OF_MEAN|1.37||0.002|TWO_SIDED|95.0|6.3|12.5||Threshold of significance at 0.05.|Wilcoxon matched pairs signed rank test|||We are comparing baseline scores at Week 0 to scores taken at the end of the treatment period in Week 12.||12.5|6.3|0.002
72366791|NCT05038982|144244431|SUPERIORITY||Mean Difference (Net)|6.1|STANDARD_ERROR_OF_MEAN|1.99||0.0215|TWO_SIDED|95.0|1.6|10.6||Threshold of significance at 0.05.|Wilcoxon matched pairs signed rank test|||We are comparing baseline scores at Week 0 to scores taken at the end of the treatment period in Week 12.||10.6|1.6|0.0215
72366792|NCT05038982|144244432|SUPERIORITY||Mean Difference (Net)|10.1|STANDARD_ERROR_OF_MEAN|1.86||0.002|TWO_SIDED|95.0|5.9|14.3||Threshold of significance at 0.05.|Wilcoxon matched pairs signed rank test|||We are comparing baseline scores at Week 0 to scores taken at the end of the treatment period in Week 12.||14.3|5.9|0.002
72366793|NCT05038982|144244432|SUPERIORITY||Mean Difference (Net)|4.7|STANDARD_ERROR_OF_MEAN|1.74||0.02|TWO_SIDED|95.0|0.77|8.6||Threshold of significance at 0.05.|Wilcoxon matched pairs signed rank test|||We are comparing baseline scores at Week 0 to scores taken at the end of the treatment period in Week 12.||8.6|0.77|0.02
72366794|NCT05038982|144244433|SUPERIORITY||Mean Difference (Net)|5.44|STANDARD_ERROR_OF_MEAN|1.21||0.0078|TWO_SIDED|95.0|2.7|8.18||Threshold of significance at 0.05.|Wilcoxon matched pairs signed rank test|||We are comparing baseline scores at Week 0 to scores taken at the end of the treatment period in Week 12.||8.18|2.70|0.0078
72366795|NCT05038982|144244434|SUPERIORITY||Mean Difference (Net)|12.73|STANDARD_ERROR_OF_MEAN|3.16||0.0098|TWO_SIDED|95.0|5.57|19.89||Threshold of significance at 0.05.|Wilcoxon matched pairs signed rank test|||We are comparing baseline scores at Week 0 to scores taken at the end of the treatment period in Week 12.||19.89|5.57|0.0098
72366796|NCT05038982|144244434|SUPERIORITY||Mean Difference (Net)|9.88|STANDARD_ERROR_OF_MEAN|3.0||0.0117|TWO_SIDED|95.0|3.1|16.66||Threshold of significance at 0.05.|Wilcoxon matched pairs signed rank test|||We are comparing baseline scores at Week 0 to scores taken at the end of the treatment period in Week 12.||16.66|3.10|0.0117
72366797|NCT05038982|144244435|SUPERIORITY||Mean Difference (Net)|10.2|STANDARD_ERROR_OF_MEAN|2.54||0.002|TWO_SIDED|95.0|4.46|15.94||Threshold of significance at 0.05.|Wilcoxon matched pairs signed rank test|||We are comparing baseline scores at Week 0 to scores taken at the end of the treatment period in Week 12.||15.94|4.46|0.002
72366798|NCT05038982|144244436|SUPERIORITY||Mean Difference (Net)|1.1|STANDARD_ERROR_OF_MEAN|0.23||0.0078|TWO_SIDED|95.0|0.57|1.63||Threshold of significance at 0.05.|Wilcoxon matched pairs signed rank test|||We are comparing baseline scores at Week 0 to scores taken at the end of the treatment period in Week 12.||1.63|0.57|0.0078
72366799|NCT05038982|144244437|SUPERIORITY||Mean Difference (Net)|0.15|STANDARD_ERROR_OF_MEAN|0.055||0.0391|TWO_SIDED|95.0|0.025|0.27||Threshold of significance at 0.05.|Wilcoxon matched pairs signed rank test|||We are comparing baseline scores at Week 0 to scores taken at the end of the treatment period in Week 12.||0.27|0.025|0.0391
72366800|NCT05038982|144244437|SUPERIORITY||Mean Difference (Net)|0.12|STANDARD_ERROR_OF_MEAN|0.086||0.28|TWO_SIDED|95.0|-0.08|0.31||Threshold of significance at 0.05.|Wilcoxon matched pairs signed rank test|||We are comparing baseline scores at Week 0 to scores taken at the end of the treatment period in Week 12.||0.31|-.080|0.28
72366801|NCT05038982|144244438|SUPERIORITY||Mean Difference (Net)|3.6|STANDARD_ERROR_OF_MEAN|1.607||0.0684|TWO_SIDED|95.0|0.035|7.235||Threshold of significance at 0.05.|Wilcoxon matched pairs signed rank test|||We are comparing baseline scores at Week 0 to scores taken at the end of the treatment period in Week 12.||7.235|0.035|0.0684
72366802|NCT05038982|144244438|SUPERIORITY||Mean Difference (Net)|1.1|STANDARD_ERROR_OF_MEAN|1.13||0.375|TWO_SIDED|95.0|-3.656|1.456||Threshold of significance at 0.05.|Wilcoxon matched pairs signed rank test|||||1.456|-3.656|0.375
72366803|NCT05038982|144244439|SUPERIORITY||Mean Difference (Net)|0.7|STANDARD_ERROR_OF_MEAN|1.212||0.207|TWO_SIDED|95.0|-3.44|2.04||Threshold of significance at 0.05.|Wilcoxon matched pairs signed rank test|||We are comparing baseline scores at Week 0 to scores taken at the end of the treatment period in Week 12.||2.04|-3.44|0.207
72366804|NCT05038982|144244439|SUPERIORITY||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|1.498||0.8125|TWO_SIDED|95.0|-3.389|3.389||Threshold of significance at 0.05.|Wilcoxon matched pairs signed rank test|||We are comparing baseline scores at Week 0 to scores taken at the end of the treatment period in Week 12.||3.389|-3.389|0.8125
72366805|NCT05038982|144244440|SUPERIORITY||Mean Difference (Net)|4.8|STANDARD_ERROR_OF_MEAN|1.009||0.0039|TWO_SIDED|95.0|2.52|7.08||Threshold of significance at 0.05.|Wilcoxon matched pairs signed rank test|||We are comparing baseline scores at Week 0 to scores taken at the end of the treatment period in Week 12.||7.08|2.52|0.0039
72366806|NCT05038982|144244440|SUPERIORITY||Mean Difference (Net)|2.3|STANDARD_ERROR_OF_MEAN|1.033||0.0547|TWO_SIDED|95.0|-0.0376|4.638||Threshold of significance at 0.05.|Wilcoxon matched pairs signed rank test|||We are comparing baseline scores at Week 0 to scores taken at the end of the treatment period in Week 12.||4.638|-0.0376|0.0547
72366807|NCT05038982|144244441|SUPERIORITY||Mean Difference (Net)|9.0||||0.0003|TWO_SIDED|95.0|6.93|11.07||Threshold of significance at 0.05.|t-test, 2 sided|||We are comparing baseline scores at Week 0 to scores taken at the end of the treatment period in Week 12.||11.07|6.93|0.0003
72366808|NCT05038982|144244442|SUPERIORITY||Mean Difference (Net)|6.429|||<|0.0001|TWO_SIDED|95.0|4.011|8.846||Threshold of significance at 0.05.|t-test, 2 sided|||||8.846|4.011|<0.0001
72366809|NCT05038982|144244444|SUPERIORITY||Median Difference (Net)|-0.58|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-0.83|-0.33||Threshold of significance set at 0.05|t-test, 2 sided|||This is a comparison of Th1 GSVA from RNA sequencing (RNASeq) performed on skin biopsies. The comparison is for CPUO patient skin at Week 0 versus Week 12 (end of treatment) The CPUO patients only had one biopsy collected at the timepoints because there are no visible lesions. CPUO patients only had one biopsy taken which will be referred to as Lesional sites. CPUO will compare Lesional biopsies at week 0 to Lesional biopsies at week 12.||-0.33|-0.83|<0.0001
72366810|NCT05038982|144244444|SUPERIORITY||Mean Difference (Net)|-0.37|STANDARD_ERROR_OF_MEAN|0.091||0.0003|TWO_SIDED|95.0|-0.56|-0.18||The threshold for significance is set at 0.05|t-test, 2 sided|||This is a comparison of Th2 GSVA from RNASeq performed on skin biopsies. The comparison is for CPUO patient skin at Week 0 versus Week 12 (end of treatment) The CPUO patients only had one biopsy collected at the timepoints because there are no visible lesions. CPUO patients only had one biopsy taken which will be referred to as Lesional sites. CPUO will compare Lesional biopsies at week 0 to Lesional biopsies at week 12.||-0.18|-0.56|0.0003
72366811|NCT05038982|144244444|SUPERIORITY||Mean Difference (Net)|-0.21|STANDARD_ERROR_OF_MEAN|0.12||0.0952|TWO_SIDED|95.0|-0.47|0.039||The threshold for significance is set at 0.05|t-test, 2 sided|||This is a comparison of Th17 GSVA from RNASeq performed on skin biopsies. The comparison is for CPUO patient skin at Week 0 versus Week 12 (end of treatment) The CPUO patients only had one biopsy collected at the timepoints because there are no visible lesions. CPUO patients only had one biopsy taken which will be referred to as Lesional sites. CPUO will compare Lesional biopsies at week 0 to Lesional biopsies at week 12.||0.039|-0.47|0.0952
72366812|NCT05038982|144244444|SUPERIORITY||Mean Difference (Net)|-0.38|STANDARD_ERROR_OF_MEAN|0.12||0.004|TWO_SIDED|95.0|-0.64|-0.13||Threshold for significance is set at 0.05|t-test, 2 sided|||This is a comparison of Th22 GSVA from RNASeq performed on skin biopsies. The comparison is for CPUO patient skin at Week 0 versus Week 12 (end of treatment) The CPUO patients only had one biopsy collected at the timepoints because there are no visible lesions. CPUO patients only had one biopsy taken which will be referred to as Lesional sites. CPUO will compare Lesional biopsies at week 0 to Lesional biopsies at week 12.||-0.13|-0.64|0.004
72366813|NCT05038982|144244444|SUPERIORITY||Mean Difference (Net)|-0.43|STANDARD_ERROR_OF_MEAN|0.18||0.0277|TWO_SIDED|95.0|-0.81|-0.053||The threshold of significance is set at 0.05|t-test, 2 sided|||This is a comparison of Th1 GSVA from RNASeq performed on skin biopsies. The comparison is for lesional PN patient skin at Week 0 versus non lesional PN patient skin at week 0.||-0.053|-0.81|0.0277
72366814|NCT05038982|144244444|SUPERIORITY||Mean Difference (Net)|-0.4|STANDARD_ERROR_OF_MEAN|0.22||0.077|TWO_SIDED|95.0|-0.85|0.049||The threshold of significance is set at 0.05|t-test, 2 sided|||This is a comparison of Th1 GSVA from RNASeq performed on skin biopsies. The comparison is for lesional PN patient skin at Week 12 versus non lesional PN patient skin at week 12.||0.049|-0.85|0.077
72366815|NCT05038982|144244444|SUPERIORITY||Mean Difference (Net)|-0.33|STANDARD_ERROR_OF_MEAN|0.15||0.0363|TWO_SIDED|95.0|-0.64|-0.024||The threshold of significance is set at 0.05|t-test, 2 sided|||This is a comparison of Th2 GSVA from RNASeq performed on skin biopsies. The comparison is for lesional PN patient skin at Week 0 versus non lesional PN patient skin at Week 0.||-0.024|-0.64|0.0363
72366816|NCT05038982|144244444|SUPERIORITY||Mean Difference (Net)|-0.29|STANDARD_ERROR_OF_MEAN|0.17||0.1|TWO_SIDED|95.0|-0.63|0.062||The threshold of significance is set at 0.05|t-test, 2 sided|||This is a comparison of Th2 GSVA from RNASeq performed on skin biopsies. The comparison is for lesional PN patient skin at Week 12 versus non lesional PN patient skin at Week 12.||0.062|-0.63|0.10
72366817|NCT05038982|144244444|SUPERIORITY||Mean Difference (Net)|-0.58|STANDARD_ERROR_OF_MEAN|0.15||0.0009|TWO_SIDED|95.0|-0.89|-0.27||The threshold for significance is set at 0.05|t-test, 2 sided|||This is a comparison of Th17 GSVA from RNASeq performed on skin biopsies. The comparison is for lesional PN patient skin at Week 0 versus non lesional PN patient skin at Week 0.||-0.27|-0.89|0.0009
72366818|NCT05038982|144244444|SUPERIORITY||Mean Difference (Net)|-0.28|STANDARD_ERROR_OF_MEAN|0.23||0.2326|TWO_SIDED|95.0|-0.77|0.2||The threshold for significance is set at 0.05|t-test, 2 sided|||This is a comparison of Th17 GSVA from RNASeq performed on skin biopsies. The comparison is for lesional PN patient skin at Week 12 versus non lesional PN patient skin at Week 12.||0.20|-0.77|0.2326
72366819|NCT05038982|144244444|SUPERIORITY||Mean Difference (Net)|-0.52|STANDARD_ERROR_OF_MEAN|0.16||0.0047|TWO_SIDED|95.0|-0.85|-0.18||The threshold for significance is set at 0.05|t-test, 2 sided|||This is a comparison of Th22 GSVA from RNASeq performed on skin biopsies. The comparison is for lesional PN patient skin at Week 0 versus non lesional PN patient skin at Week 0.||-0.18|-0.85|0.0047
72366820|NCT05038982|144244444|SUPERIORITY||Mean Difference (Net)|-0.41|STANDARD_ERROR_OF_MEAN|0.2||0.0539|TWO_SIDED|95.0|-0.83|0.0076||The threshold for significance is set at 0.05|t-test, 2 sided|||This is a comparison of Th22 GSVA from RNASeq performed on skin biopsies. The comparison is for lesional PN patient skin at Week 12 versus non lesional PN patient skin at Week 12.||0.0076|-0.83|0.0539
72366821|NCT00472576|144244473|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.291|STANDARD_ERROR_OF_MEAN|0.693||0.001|TWO_SIDED|95.0|0.911|3.671|||Mixed Models Analysis||Mean differences reflect groups differences at end point.|A linear mixed model with restricted maximum likelihood estimation was used to examine the effects of treatment (MK-0657 and placebo) over time (treatment day) with the baseline of each phase as a covariate. A main effect for phase of study was also included. Schwarz's Bayesian criteria was used to determine the best fitting variance-covariance structure which was an autoregressive moving average model. Bonferroni adjusted simple effects tests were used to evaluate significant effects.||3.671|0.911|.001
72366822|NCT00472576|144244474|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.04|STANDARD_ERROR_OF_MEAN|2.479||0.272|TWO_SIDED|95.0|-6.981|2.901||This test is a comparison of the MK-0657 condition to the placebo condition.|Mixed Models Analysis||The primary outcome of interest is whether the groups differ at the end of the study, so the means represent values at that point in time.|A linear mixed model with restricted maximum likelihood estimation was used to examine the effects of treatment (MK-0657 and placebo) over time (treatment day) with the baseline of each phase as a covariate. A main effect for phase of study was also included. Schwarz's Bayesian criteria was used to determine the best fitting variance-covariance structure which was an autoregressive moving average model. Bonferroni adjusted simple effects tests were used to evaluate significant effects.||2.901|-6.981|.272
72366823|NCT02557139|144244479|EQUIVALENCE|If the 90% confidence interval for the comparison of fed vs. fasted is within the acceptance range 80.00% to 125.00%, then it is concluded that there is no effect of food on belumosudil tablets.|Ratio of Adjusted Geometric Means (%)|100.0|||<|0.001|TWO_SIDED|90.0|80.0|125.0|||t-test, 2 sided|||Cmax null hypothesis: Ratio of Adjusted Geometric Means = 100%|Intra-subject variability: 48.00%|125.00|80.00|< 0.001
72366824|NCT02557139|144244479|EQUIVALENCE|If the 90% confidence interval for the comparison of belumosudil tablet (test drug) vs. the belumosudil capsule (reference drug) is within the acceptance range 80.00% to 125.00%, then it is concluded that there is no effect on the use of belumosudi tablet compared to belumosudil capsule.|Ratio of Geometric Means (%)|100.0||||0.23|TWO_SIDED|90.0|80.0|125.0|||t-test, 2 sided|||Cmax null hypothesis: Ratio of Adjusted Geometric Means = 100%|Intra-subject variability: 48.00%|125.00|80.00|0.23
72366825|NCT02557139|144244480|EQUIVALENCE|If the 90% confidence interval for the comparison of fed vs. fasted is within the acceptance range 80.00% to 125.00%, then it is concluded that there is no effect of food on belumosudil tablets.|Ratio of Adjusted Geometric Means (%)|100.0|||<|0.001|TWO_SIDED|90.0|80.0|125.0|||t-test, 2 sided|||AUC(0-inf) Null Hypothesis: Ratio of Adjusted Geometric Means = 100%|Intra-subject variability: 34.25%|125.00|80.00|<0.001
72366826|NCT02557139|144244480|EQUIVALENCE|If the 90% confidence interval for the comparison of belumosudil tablet (test drug) vs. the belumosudil capsule (reference drug) is within the acceptance range 80.00% to 125.00%, then it is concluded that there is no effect on the use of belumosudi tablet compared to belumosudil capsule.|Ratio of Adjusted Geometric Means (%)|100.0||||0.16|TWO_SIDED|90.0|80.0|125.0|||t-test, 2 sided|||AUC(0-inf) Null Hypothesis: Ratio of Adjusted Geometric Means = 100%|Intra-subject variability;|125.00|80.00|0.16
72366827|NCT02557139|144244480|EQUIVALENCE|If the 90% confidence interval for the comparison of fed vs. fasted is within the acceptance range 80.00% to 125.00%, then it is concluded that there is no effect of food on belumosudil tablets.|Ratio of Adjusted Geometric Means (%)|100.0|||<|0.001|TWO_SIDED|90.0|80.0|125.0|||t-test, 2 sided|||AUC(0-last) Null Hypothesis: Ratio of Adjusted Geometric Means = 100%|Intra-subject variability = 38.16%|125.00|80.00|< 0.001
72366828|NCT02557139|144244480|EQUIVALENCE|If the 90% confidence interval for the comparison of belumosudil tablet (test drug) vs. the belumosudil capsule (reference drug) is within the acceptance range 80.00% to 125.00%, then it is concluded that there is no effect on the use of belumosudi tablet compared to belumosudil capsule.|Ratio of Adjusted Geometric Means (%)|100.0||||0.18|TWO_SIDED|90.0|80.0|125.0|||t-test, 2 sided||Intra-subject variability = 38.16%|AUC(0-last) Null Hypothesis: Ratio of Adjusted Geometric Means = 100%|Intra-subject variability = 38.16%|125.00|80.00|0.18
72366829|NCT02148874|144244506|SUPERIORITY||Odds Ratio (OR)|1.05||||0.84|TWO_SIDED|95.0|0.64|1.73|||Regression, Logistic|Cumulative logistic regression model|Cumulative logistic regression model, OR for obese vs. non-obese. Model adjusted for mother's age, parity, gestational age at vaccination, vaccination season, and prior year vaccination (Y/N).|Statistical analysis for influenza strain A/H1N1.||1.73|0.64|0.84
72366830|NCT02148874|144244506|SUPERIORITY||Odds Ratio (OR)|1.07||||0.79|TWO_SIDED|95.0|0.65|1.75|||Regression, Logistic|Cumulative logistic regression model|Cumulative logistic regression model, OR for obese vs. non-obese. Model adjusted for mother's age, parity, gestational age at vaccination, vaccination season, and prior year vaccination (Y/N).|Statistical analysis for influenza strain A/H3N2||1.75|0.65|0.79
72366831|NCT02148874|144244506|SUPERIORITY||Odds Ratio (OR)|1.26||||0.43|TWO_SIDED|95.0|0.71|2.24|||Regression, Logistic|Cumulative logistic regression model|Cumulative logistic regression model, OR for obese vs. non-obese. Model adjusted for mother's age, parity, gestational age at vaccination, vaccination season, and prior year vaccination (Y/ N).|Statistical analysis for influenza strain B/Massachusetts||2.24|0.71|0.43
72366832|NCT02148874|144244506|SUPERIORITY||Odds Ratio (OR)|1.08||||0.77|TWO_SIDED|95.0|0.63|1.87|||Regression, Logistic||Cumulative logistic regression model, OR for obese vs. non-obese. Model adjusted for mother's age, parity, gestational age at vaccination, vaccination season, and prior year vaccination (Y/ N).|Statistical analysis for influenza strain B/Brisbane||1.87|0.63|0.77
72366833|NCT02148874|144244507|SUPERIORITY||Odds Ratio (OR)|1.39||||0.2|TWO_SIDED|95.0|0.84|2.32|||Regression, Logistic|Cumulative logistic regression model|Cumulative logistic regression model, OR for obese vs. non-obese. Model adjusted for mother's age, parity, gestational age at vaccination, vaccination season, and prior year vaccination (Y/N).|Statistical analysis for influenza strain A/H1N1||2.32|0.84|0.20
72366834|NCT02148874|144244507|SUPERIORITY||Odds Ratio (OR)|1.09||||0.74|TWO_SIDED|95.0|0.66|1.8|||Regression, Logistic|Cumulative logistic regression model|Cumulative logistic regression model, OR for obese vs. non-obese. Model adjusted for mother's age, parity, gestational age at vaccination, vaccination season, and prior year vaccination (Y/N).|Statistical analysis for influenza strain A/H3N2||1.80|0.66|0.74
72366835|NCT02148874|144244507|SUPERIORITY||Odds Ratio (OR)|1.89||||0.04|TWO_SIDED|95.0|1.04|3.44|||Regression, Logistic|Cumulative logistic regression model|Cumulative logistic regression model, OR for obese vs. non-obese. Model adjusted for mother's age, parity, gestational age at vaccination, vaccination season, and prior year vaccination (Y/N).|Statistical analysis for influenza strain B/Massachusetts||3.44|1.04|0.04
72366836|NCT02148874|144244507|SUPERIORITY||Odds Ratio (OR)|1.63||||0.13|TWO_SIDED|95.0|0.87|3.04|||Regression, Logistic|Cumulative logistic regression model|Cumulative logistic regression model, OR for obese vs. non-obese. Model adjusted for mother's age, parity, gestational age at vaccination, vaccination season, and prior year vaccination (Y/N).|Statistical analysis for influenza strain B/Brisbane||3.04|0.87|0.13
72366837|NCT02148874|144244508|SUPERIORITY||Odds Ratio (OR)|0.89||||0.64|TWO_SIDED|95.0|0.53|1.48|||Regression, Logistic|Cumulative logistic regression model|Cumulative logistic regression model, OR for obese vs. non-obese. Model adjusted for mother's age, parity, gestational age at vaccination, vaccination season, and prior year vaccination (Y/N).|Statistical analysis for influenza strain A/H1N1||1.48|0.53|0.64
72366838|NCT02148874|144244508|SUPERIORITY||Odds Ratio (OR)|0.89||||0.67|TWO_SIDED|95.0|0.53|1.5|||Regression, Logistic|Cumulative logistic regression model|Cumulative logistic regression model, OR for obese vs. non-obese. Model adjusted for mother's age, parity, gestational age at vaccination, vaccination season, and prior year vaccination (Y/N).|Statistical analysis for influenza strain A/H3N2||1.50|0.53|0.67
72366839|NCT02148874|144244508|SUPERIORITY||Odds Ratio (OR)|1.47||||0.14|TWO_SIDED|95.0|0.88|2.46|||Regression, Logistic|Cumulative logistic regression model|Cumulative logistic regression model, OR for obese vs. non-obese. Model adjusted for mother's age, parity, gestational age at vaccination, vaccination season, and prior year vaccination (Y/N).|Statistical analysis for influenza strain B/Massachusetts||2.46|0.88|0.14
72366840|NCT02148874|144244508|SUPERIORITY||Odds Ratio (OR)|0.74||||0.25|TWO_SIDED|95.0|0.44|1.24|||Regression, Logistic|Cumulative logistic regression model|Cumulative logistic regression model, OR for obese vs. non-obese. Model adjusted for mother's age, parity, gestational age at vaccination, vaccination season, and prior year vaccination (Y/N).|Statistical analysis for influenza strain B/Brisbane||1.24|0.44|0.25
72366841|NCT02592798|144244509|SUPERIORITY||Mean Difference (Final Values)|-7.7|||||TWO_SIDED|95.0|-46.8|33.3|||||Abatacept - Placebo for Double-Blind Period Day 113|||33.3|-46.8|
72366842|NCT02592798|144244509|SUPERIORITY||Mean Difference (Final Values)|-20.8|||||TWO_SIDED|95.0|-63.3|24.3|||||Abatacept - Placebo for Open Label Period Day 113|||24.3|-63.3|
72366843|NCT02592798|144244510|SUPERIORITY||Mean Difference (Final Values)|0.37|||||TWO_SIDED|95.0|-1.6495|2.3855|||||Abatacept - Placebo for Double-Blind Period Day 113|||2.3855|-1.6495|
72366844|NCT02592798|144244510|SUPERIORITY||Mean Difference (Final Values)|1.95|||||TWO_SIDED|95.0|-1.7933|5.6954|||||Abatacept - Placebo for Open Label Period Day 113|||5.6954|-1.7933|
72366845|NCT02592798|144244511|SUPERIORITY||Mean Difference (Final Values)|0.13|||||TWO_SIDED|95.0|-0.1483|0.4119|||||Abatacept - Placebo for Double-Blind Period Day 113|||0.4119|-0.1483|
72366846|NCT02592798|144244511|SUPERIORITY||Mean Difference (Final Values)|0.12|||||TWO_SIDED|95.0|-0.5107|0.7551|||||Abatacept - Placebo for Open Label Period Day 113|||0.7551|-0.5107|
72366847|NCT02592798|144244512|SUPERIORITY||Mean Difference (Final Values)|1.4|||||TWO_SIDED|95.0|-44.7|44.7|||||Abatacept - Placebo for Open Label Period Day 113|||44.7|-44.7|
72366848|NCT02592798|144244513|SUPERIORITY||Mean Difference (Final Values)|-0.69|||||TWO_SIDED|95.0|-8.1395|6.7645|||||Abatacept - Placebo for Fatigue|||6.7645|-8.1395|
72366849|NCT02592798|144244513|SUPERIORITY||Mean Difference (Final Values)|-3.7|||||TWO_SIDED|95.0|-13.9402|6.5402|||||Abatacept - Placebo for Pain interference|||6.5402|-13.9402|
72366850|NCT02592798|144244513|SUPERIORITY||Mean Difference (Final Values)|-1.0|||||TWO_SIDED|95.0|-6.5736|4.5736|||||Abatacept - Placebo for Physical function|||4.5736|-6.5736|
72366851|NCT02592798|144244514|SUPERIORITY||Mean Difference (Final Values)|12.45|||||TWO_SIDED|95.0|-4.595|29.485|||||Abatacept - Placebo for Fatigue|||29.4850|-4.5950|
72366852|NCT02592798|144244514|SUPERIORITY||Mean Difference (Final Values)|7.14|||||TWO_SIDED|95.0|-2.5917|16.8717|||||Abatacept - Placebo for Pain interference|||16.8717|-2.5917|
72366853|NCT02592798|144244514|SUPERIORITY||Mean Difference (Final Values)|-0.88|||||TWO_SIDED|95.0|-12.1068|10.3468|||||Abatacept - Placebo for Mobility|||10.3468|-12.1068|
72366854|NCT00705016|144244523|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.03||||0.885|TWO_SIDED|95.0|0.67|1.59||The Type I error was not taken into account, since the sample size calculation is based on selection theory.|Cox proportional hazards model|Stratification factor: Karnofsky performance status (KPS) \<80/\>=80||Sample size of 177 subjects was estimated such that the treatment group with the best PFS result had a 90% probability of emerging as the one with the smaller observed log Hazard ratio (HR), if there was an underlying difference of 2.2 months between the arms in the median PFS (7.8 months in the best group and 5.6 months in the other 2 groups). It was assumed that the accrual and follow-up time would take 1 year each, and that the drop-out rate was 8%.||1.59|0.67|0.885
72366855|NCT00705016|144244523|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.55||||0.054|TWO_SIDED|95.0|0.99|2.43||The Type I error was not taken into account, since the sample size calculation is based on selection theory.|Cox proportional hazards model|Stratification factor: Karnofsky performance status (KPS) \<80/\>=80||Sample size of 177 subjects was estimated such that the treatment group with the best PFS result had a 90% probability of emerging as the one with the smaller observed log HR, if there was an underlying difference of 2.2 months between the arms in the median PFS (7.8 months in the best group and 5.6 months in the other 2 groups). It was assumed that the accrual and follow-up time would take 1 year each, and that the drop-out rate was 8%.||2.43|0.99|0.054
72366856|NCT00705016|144244524|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.94||||0.8|TWO_SIDED|95.0|0.61|1.47||Secondary analyses of efficacy were performed to support the results of the primary analysis and considered as purely exploratory and no adjustment for multiplicity has been done.|Cox proportional hazards model|||||1.47|0.61|0.800
72366857|NCT00705016|144244524|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.04||||0.878|TWO_SIDED|95.0|0.66|1.63|||Cox proportional hazards model|||||1.63|0.66|0.878
72366858|NCT00705016|144244525|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.595||||0.205|TWO_SIDED|95.0|0.776|3.276||Secondary analyses of efficacy were performed to support the results of the primary analysis and considered as purely exploratory and no adjustment for multiplicity has been done.|Cochran-Mantel-Haenszel|||||3.276|0.776|0.205
72366859|NCT00705016|144244525|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.671||||0.317|TWO_SIDED|95.0|0.307|1.465||Secondary analyses of efficacy were performed to support the results of the primary analysis and considered as purely exploratory and no adjustment for multiplicity has been done.|Cochran-Mantel-Haenszel|||||1.465|0.307|0.317
72366860|NCT00705016|144244526|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.396||||0.476|TWO_SIDED|95.0|0.551|3.539||Secondary analyses of efficacy were performed to support the results of the primary analysis and considered as purely exploratory and no adjustment for multiplicity has been done.|Cochran-Mantel-Haenszel|||||3.539|0.551|0.476
72366861|NCT00705016|144244526|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.668||||0.347|TWO_SIDED|95.0|0.287|1.555||Secondary analyses of efficacy were performed to support the results of the primary analysis and considered as purely exploratory and no adjustment for multiplicity has been done.|Cochran-Mantel-Haenszel|||||1.555|0.287|0.347
72366862|NCT00705016|144244527|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.23||||0.294|TWO_SIDED|95.0|0.84|1.81||Secondary analyses of efficacy were performed to support the results of the primary analysis and considered as purely exploratory and no adjustment for multiplicity has been done.|Cox proportional hazards model|||||1.81|0.84|0.294
72366863|NCT00705016|144244527|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.73||||0.007|TWO_SIDED|95.0|1.16|2.57||Secondary analyses of efficacy were performed to support the results of the primary analysis and considered as purely exploratory and no adjustment for multiplicity has been done.|Cox proportional hazards model|||||2.57|1.16|0.007
72366864|NCT00705016|144244528|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.3||||0.391|TWO_SIDED|95.0|0.71|2.39||Secondary analyses of efficacy were performed to support the results of the primary analysis and considered as purely exploratory and no adjustment for multiplicity has been done.|Cox proportional hazards model|||||2.39|0.71|0.391
72366865|NCT00705016|144244528|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.6||||0.007|TWO_SIDED|95.0|1.3|5.21||Secondary analyses of efficacy were performed to support the results of the primary analysis and considered as purely exploratory and no adjustment for multiplicity has been done.|Cox proportional hazards model|||||5.21|1.30|0.007
72366866|NCT02233517|144244530|SUPERIORITY||Mean Difference (Net)|-0.1|STANDARD_ERROR_OF_MEAN|0.51||0.84|TWO_SIDED||||||Mixed Models Analysis||Baseline to post-treatment. The reference condition is the present centered therapy arm.|||||0.84
72366867|NCT02233517|144244530|SUPERIORITY||Slope|0.23|STANDARD_ERROR_OF_MEAN|0.52|<|0.44|TWO_SIDED||||||Mixed Models Analysis||Baseline to 3 months post-treatment. The reference condition is the present centered therapy arm.|||||<0.44
72366868|NCT02233517|144244530|SUPERIORITY||Slope|0.5|STANDARD_ERROR_OF_MEAN|0.51||0.33|TWO_SIDED||||||Mixed Models Analysis||Baseline to 6 months post-treatment. The reference condition is the present centered therapy arm.|||||0.33
72366869|NCT02233517|144244531|SUPERIORITY|Estimation parameter is interaction of session by therapy, or estimate of difference in mean between CBT and PCT per time point. Positive value is less decrease over time in CBT arm (greater decrease in anger over time in PCT).|Mean Difference (Net)|0.11|STANDARD_ERROR_OF_MEAN|0.1||0.26|TWO_SIDED||||||Mixed Models Analysis|||Multilevel model of therapy type (1=CBT, 2=PCT), gender, and time on DAR scores, using data from baseline, 12 sessions, post-treatment, 3-month and 6-month follow up.||||0.26
72366870|NCT02233517|144244532|SUPERIORITY||Mean Difference (Net)|-0.14|STANDARD_ERROR_OF_MEAN|1.16||0.9|TWO_SIDED||||||Mixed Models Analysis||Baseline to post-treatment. The reference condition is the present centered therapy arm.|||||0.90
72366871|NCT02233517|144244532|SUPERIORITY||Mean Difference (Net)|0.22|STANDARD_ERROR_OF_MEAN|1.16||0.85|TWO_SIDED||||||Mixed Models Analysis||Baseline to 3 months post-treatment. The reference condition is the present centered therapy arm.|||||0.85
72366872|NCT02233517|144244532|SUPERIORITY||Mean Difference (Net)|0.31|STANDARD_ERROR_OF_MEAN|1.16||0.79|TWO_SIDED||||||Mixed Models Analysis||Baseline to 6 months post-treatment. The reference condition is the present centered therapy arm.|||||0.79
72366873|NCT02233517|144244533|SUPERIORITY||Mean Difference (Net)|-2.3|STANDARD_DEVIATION|3.2||0.05|TWO_SIDED|95.0|-4.5|-0.002|||t-test, 2 sided|||This is the comparison of change in means for cognitive-behavioral vs. present-centered therapy from baseline to post-treatment for the Extent of Participation scale.||-.002|-4.5|0.05
72366874|NCT02233517|144244533|SUPERIORITY||Mean Difference (Net)|-0.47|STANDARD_DEVIATION|2.09||0.53|TWO_SIDED|95.0|-2.03|1.08|||t-test, 2 sided|||This is the comparison of change in means for cognitive-behavioral vs. present-centered therapy from baseline to post-treatment for the Perceived Limitations scale.||1.08|-2.03|0.53
72366875|NCT02233517|144244533|SUPERIORITY||Mean Difference (Net)|-0.58|STANDARD_DEVIATION|2.42||0.5|TWO_SIDED|95.0|-2.3|1.14|||t-test, 2 sided|||This is the comparison of change in means for cognitive-behavioral vs. present-centered therapy from baseline to post-treatment for the Satisfaction scale.||1.14|-2.30|0.50
72366876|NCT02233517|144244534|SUPERIORITY||Mean Difference (Net)|0.28|STANDARD_ERROR_OF_MEAN|0.06|<|0.0001|TWO_SIDED||||||Mixed Models Analysis||The estimation parameter of 0.28 indicates that at each of the 16 time points, participants in the CBT arm had 0.28 point less of a decrease in disability than those in PCT arm.|Estimation parameter is interaction of session by therapy, or estimate of difference in mean between CBT and PCT per time point. Positive value is less decrease over time in CBT arm (greater decrease in anger over time in PCT).||||<0.0001
72366877|NCT02233517|144244535|SUPERIORITY||Mean Difference (Net)|1.45|STANDARD_ERROR_OF_MEAN|2.71||0.59|TWO_SIDED||||||Mixed Models Analysis||Baseline to post-treatment. The reference condition is the present centered therapy arm.|||||0.59
72366878|NCT02233517|144244535|SUPERIORITY||Mean Difference (Net)|1.37|STANDARD_ERROR_OF_MEAN|2.71||0.61|TWO_SIDED||||||Mixed Models Analysis||Baseline to 3 months post-treatment. The reference condition is the present centered therapy arm.|||||0.61
72366879|NCT02233517|144244535|SUPERIORITY||Mean Difference (Net)|-0.89|STANDARD_ERROR_OF_MEAN|2.71||0.74|TWO_SIDED||||||Mixed Models Analysis||Baseline to 6 months post-treatment. The reference condition is the present centered therapy arm.|||||0.74
72366880|NCT02233517|144244536|SUPERIORITY||Mean Difference (Net)|-0.19|STANDARD_ERROR_OF_MEAN|0.16||0.25|TWO_SIDED||||||Mixed Models Analysis||Baseline to post-treatment. The reference condition is the present centered therapy arm.|||||0.25
72366881|NCT02233517|144244536|SUPERIORITY||Mean Difference (Net)|0.006|STANDARD_ERROR_OF_MEAN|0.16||0.97|TWO_SIDED||||||Mixed Models Analysis||Baseline to 3 months post-treatment. The reference condition is the present centered therapy arm.|||||0.97
72366882|NCT02233517|144244536|SUPERIORITY||Mean Difference (Net)|0.07|STANDARD_ERROR_OF_MEAN|0.17||0.69|TWO_SIDED||||||Mixed Models Analysis||Baseline to 6 months post-treatment. The reference condition is the present centered therapy arm.|||||0.69
72366883|NCT02233517|144244537|SUPERIORITY||Mean Difference (Net)|-0.71|STANDARD_ERROR_OF_MEAN|0.66||0.29|TWO_SIDED||||||Mixed Models Analysis||Baseline to post-treatment. The reference condition is the present centered therapy arm.|||||0.29
72366884|NCT02233517|144244537|SUPERIORITY||Mean Difference (Net)|-0.52|STANDARD_ERROR_OF_MEAN|0.66||0.44|TWO_SIDED||||||Mixed Models Analysis||Baseline to 3 months post-treatment. The reference condition is the present centered therapy arm.|||||0.44
72366885|NCT02233517|144244537|SUPERIORITY||Mean Difference (Net)|-1.06|STANDARD_ERROR_OF_MEAN|0.66||0.11|TWO_SIDED||||||Mixed Models Analysis||Baseline to 6 months post-treatment. The reference condition is the present centered therapy arm.|||||0.11
72366886|NCT02233517|144244538|SUPERIORITY||Mean Difference (Net)|0.17|STANDARD_ERROR_OF_MEAN|0.12||0.16|TWO_SIDED||||||Mixed Models Analysis||Estimation parameter is interaction of session by therapy, or estimate of difference in mean between CBT and PCT per time point. Positive value is less decrease over time in CBT arm (greater decrease in PTSD in PCT).|Multilevel model of therapy type (1=CBT, 2=PCT), gender, and time on PCL Total scores, using data from baseline, 12 sessions, post-treatment, 3-month and 6-month follow up.||||0.16
72366887|NCT02233517|144244539|SUPERIORITY||Mean Difference (Net)|0.28|STANDARD_ERROR_OF_MEAN|0.37||0.45|TWO_SIDED||||||Mixed Models Analysis||Baseline to post-treatment. The reference condition is the present centered therapy arm.|||||0.45
72366888|NCT02233517|144244539|SUPERIORITY||Mean Difference (Net)|-0.23|STANDARD_ERROR_OF_MEAN|0.37||0.55|TWO_SIDED||||||Mixed Models Analysis||Baseline to 3 months post-treatment. The reference condition is the present centered therapy arm.|||||0.55
72366889|NCT02233517|144244539|SUPERIORITY||Mean Difference (Net)|0.06|STANDARD_ERROR_OF_MEAN|0.37||0.87|TWO_SIDED||||||Mixed Models Analysis||Baseline to 6 months post-treatment. The reference condition is the present centered therapy arm.|||||0.87
72366890|NCT02233517|144244540|SUPERIORITY||Mean Difference (Net)|-0.71|STANDARD_ERROR_OF_MEAN|1.04||0.49|TWO_SIDED||||||Mixed Models Analysis||Baseline to post-treatment.|||||0.49
72366891|NCT02233517|144244540|SUPERIORITY||Mean Difference (Net)|-0.41|STANDARD_ERROR_OF_MEAN|1.04||0.7|TWO_SIDED||||||Mixed Models Analysis||Baseline to 3 months post-treatment. The reference condition is the present centered therapy arm.|||||0.70
72366892|NCT02233517|144244540|SUPERIORITY||Mean Difference (Net)|-0.78|STANDARD_ERROR_OF_MEAN|1.04||0.45|TWO_SIDED||||||Mixed Models Analysis||Baseline to 6 months post-treatment. The reference condition is the present centered therapy arm.|||||0.45
72366893|NCT05567783|144244541|SUPERIORITY||Relative risk reduction (RRR, %)|15.85||||0.5552|TWO_SIDED|95.0|-49.27|52.56||two-sided, alpha=0.05|Poisson regression|Estimated using Poisson regression of multiple imputed data with treatment group the only factor in the model|RRR and 95% CI estimated using Poisson regression of multiple imputed data with treatment group was the only factor in the model|||52.56|-49.27|0.5552
72366894|NCT05567783|144244541|SUPERIORITY||Relative risk reduction (RRR, %)|3.78|||||TWO_SIDED|95.0|-67.23|44.63|||||RRR and 95% CI estimated using Poisson regression of multiple imputed data with treatment group the only factor in the model; 95% CI are nominal and not adjusted for multiple comparisons.|||44.63|-67.23|
72366895|NCT05567783|144244549|SUPERIORITY||Relative risk reduction (RRR, %)|57.23|||||TWO_SIDED|95.0|-2.51|82.15|||||RRR and 95% CI estimated using Poisson regression of multiple imputed data with treatment group the only factor in the model; 95%CI are nominal and not adjusted for multiple comparisons.|||82.15|-2.51|
72366896|NCT05567783|144244549|SUPERIORITY||Relative risk reduction (RRR, %)|11.45|||||TWO_SIDED|95.0|-76.25|55.51|||||RRR and 95% CI estimated using Poisson regression of multiple imputed data with treatment group the only factor in the model; 95% CI are nominal and not adjusted for multiple comparisons.|||55.51|-76.25|
72366897|NCT05567783|144244550|SUPERIORITY||Relative risk reduction (RRR, %)|44.13|||||TWO_SIDED|95.0|-50.49|79.26|||||RRR and 95% CI estimated using Poisson regression of multiple imputed data with treatment group the only factor in the model; 95%CI are nominal and not adjusted for multiple comparisons.|||79.26|-50.49|
72366898|NCT05567783|144244550|SUPERIORITY||Relative risk reduction (RRR, %)|-9.8|||||TWO_SIDED|95.0|-147.41|51.27|||||RRR and 95% CI estimated using Poisson regression of multiple imputed data with treatment group the only factor in the model; 95% CI are nominal and not adjusted for multiple comparisons.|||51.27|-147.41|
72366899|NCT04916587|144244551|SUPERIORITY||Risk Difference (RD)|11.6|||||TWO_SIDED|95.0|10.6|12.6||||||||12.6|10.6|
72366900|NCT04916587|144244552|SUPERIORITY||Risk Difference (RD)|7.5|||||TWO_SIDED|95.0|6.6|8.3||||||||8.3|6.6|
72366901|NCT04916587|144244553|SUPERIORITY||Odds Ratio (OR)|0.36||||0.03|TWO_SIDED|90.0|0.14|0.89|||Mixed Models Analysis|||||0.89|0.14|0.03
72366902|NCT02048670|144244557|SUPERIORITY|||||||0.005|||||||Kruskal-Wallis|||Condition 1 - eyes open, visual surround locked, platform locked||||0.005
72366903|NCT02048670|144244557|SUPERIORITY|||||||0.006|||||||Kruskal-Wallis|||Condition 2 - eyes closed, visual surround locked, platform locked||||0.006
72366904|NCT02048670|144244557|SUPERIORITY|||||||0.051|||||||Kruskal-Wallis|||Condition 3 - eyes open, visual surround unlocked, platform locked||||0.051
72366905|NCT02048670|144244557|SUPERIORITY|||||||0.173|||||||Kruskal-Wallis|||Condition 4 - eyes open, visual surround locked, platform unlocked||||0.173
72366906|NCT02048670|144244557|SUPERIORITY|||||||0.985|||||||Kruskal-Wallis|||Condition 5 - eyes closed, visual surround locked, platform unlocked||||0.985
72366907|NCT02048670|144244557|SUPERIORITY|||||||0.003|||||||Kruskal-Wallis|||Condition 6 - eyes open, visual surround unlocked, platform unlocked||||0.003
72366908|NCT03070964|144244574|SUPERIORITY||Exact binomial estimator|16.7|||||TWO_SIDED|95.0|2.1|48.4||||||||48.4|2.1|
72366909|NCT01285557|144244575|SUPERIORITY||Hazard Ratio (HR)|0.99||||0.9312|TWO_SIDED|95.0|0.76|1.28|||Unstratified Log-rank|||S-1+Cisplatin and 5FU+Cisplatin were compared using the unstratified log-rank test. The hazard ratio was estimated using a Cox's regression approach and survival was summarized using Kaplan Meier estimates along with 2-sided 95% confidence intervals (CI) for the estimates.||1.28|0.76|0.9312
72366910|NCT01285557|144244576|SUPERIORITY||Hazard Ratio (HR)|0.86||||0.3039|TWO_SIDED|95.0|0.65|1.14|||Log Rank|||S-1+Cisplatin and 5FU+Cisplatin were compared using the log-rank test. The hazard ratio was estimated using a Cox's regression approach and survival was summarized using Kaplan Meier estimates along with 2-sided 95% confidence intervals (CI) for the estimates.||1.14|0.65|0.3039
72366911|NCT01285557|144244577|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.1683|TWO_SIDED|95.0|0.66|1.08|||Log Rank|||S-1+Cisplatin and 5FU+Cisplatin were compared using the log-rank test. The hazard ratio was estimated using a Cox's regression approach and survival was summarized using Kaplan Meier estimates along with 2-sided 95% confidence intervals (CI) for the estimates.||1.08|0.66|0.1683
72366912|NCT03173248|144244608|SUPERIORITY||Hazard Ratio (HR)|0.33||||0.0011|TWO_SIDED|95.0|0.16|0.69||P-value is calculated from the one-sided log-rank test stratified by the randomization stratification factors (AML status and geographic region).|Log Rank||Hazard ratio is estimated using a Cox's proportional hazards model stratified by the randomization stratification factors (AML status and geographic region) with placebo + azacitidine as the denominator.|||0.69|0.16|0.0011
72366913|NCT04922216|144244661|SUPERIORITY||Mean Difference (Net)|0.3||||0.52|TWO_SIDED|95.0|-0.61|1.2|||Mixed Models Analysis|Degrees of freedom (2,622)|Standard dietary monitoring coded as 0 (reference) and simplified dietary monitoring coded as 1; a positive estimation parameter indicates that the reference group had greater (more negative) weight loss.|ITT analysis for factor 1 (dietary self-monitoring) using linear mixed models comparing the effect of standard dietary monitoring to simplified dietary monitoring on weight change over time (from baseline to 6 months).||1.20|-0.61|0.52
72368814|NCT02637037|144247321|NON_INFERIORITY_OR_EQUIVALENCE|If the 90% CIs for both dapagliflozin and metformin geometric mean ratio of AUC is entirely contained within an 80.00% to 125.00% interval, it will be concluded the 2 manufacturing sites are bioequivalent.|Ratios of Geometric means|0.97|||||TWO_SIDED|90.0|0.9|1.06||||||Dapagliflozin: Statistical Assessment of Bioequivalence for Dapagliflozin following administration Dapagliflozin/Metformin XR 5/500 mg for Treatment C and D.||1.06|0.90|
72366914|NCT04922216|144244661|SUPERIORITY||Mean Difference (Net)|-0.28||||0.54|TWO_SIDED|95.0|-1.19|0.63|||Mixed Models Analysis|Degrees of freedom (2,622)|Weekly adaptive goals coded as 0 (reference) and daily adaptive goals coded as 1; a positive estimation parameter indicates that the reference group had greater (more negative) weight loss.|ITT analysis for factor 2 (adaptive activity goals) using linear mixed models comparing the effect of weekly adaptive activity goals versus daily adaptive activity goals on weight change over time (from baseline to 6 months).||0.63|-1.19|0.54
72366915|NCT04922216|144244661|SUPERIORITY||Mean Difference (Net)|0.4||||0.39|TWO_SIDED|95.0|-0.5|1.31|||Mixed Models Analysis|Degrees of freedom (2,622)|Fixed message decision points coded as 0 (reference) and adaptive message decision points coded as 1; a positive estimation parameter indicates that the reference group had greater (more negative) weight loss.|ITT analysis for factor 3 (message decision points) using linear mixed models comparing the effect of weekly adaptive activity goals versus daily adaptive activity goals on weight change over time (from baseline to 6 months).||1.31|-0.50|0.39
72366916|NCT04922216|144244661|SUPERIORITY||Mean Difference (Net)|0.39||||0.7|TWO_SIDED|95.0|-0.52|1.3|||Mixed Models Analysis|Degrees of freedom (2,622)|Standard decision rules coded as 0 (reference) and adaptive decision rules coded as 1; a positive estimation parameter indicates that the reference group had greater (more negative) weight loss.|ITT analysis for factor 4 (message decision rules) using linear mixed models comparing the effect of standard decision rules to adaptive decision rules on weight change over time (from baseline to 6 months).||1.30|-0.52|0.70
72366917|NCT04922216|144244661|SUPERIORITY||Mean Difference (Net)|-0.55||||0.47|TWO_SIDED|95.0|-1.45|0.36|||Mixed Models Analysis|Degrees of freedom (2,622)|No choice points coded as 0 (reference) and Choice coded as 1; a positive estimation parameter indicates that the reference group had greater (more negative) weight loss.|ITT analysis for factor 5 (participant choice) using linear mixed models comparing the effect of no participant message choice versus participant message choice on weight change over time (from baseline to 6 months).||0.36|-1.45|0.47
72366918|NCT04922216|144244662|SUPERIORITY||Mean Difference (Net)|0.24||||0.43|TWO_SIDED|95.0|-0.36|0.84|||Mixed Models Analysis|DF (2,622)|Standard dietary monitoring coded as 0 (reference) and simplified dietary monitoring coded as 1; a positive estimation parameter indicates that the reference group had greater (more negative) weight loss.|ITT analysis for factor 1 (dietary self-monitoring) using linear mixed models comparing the effect of standard dietary monitoring to simplified dietary monitoring on weight change over time (from baseline to 3 months).||0.84|-0.36|0.43
72366919|NCT04922216|144244662|SUPERIORITY||Mean Difference (Net)|-0.42||||0.17|TWO_SIDED|95.0|-1.01|0.18|||Mixed Models Analysis|DF (2,622)|Weekly adaptive goals coded as 0 (reference) and daily adaptive goals coded as 1; a positive estimation parameter indicates that the reference group had greater (more negative) weight loss.|ITT analysis for factor 2 (adaptive activity goals) using linear mixed models comparing the effect of weekly adaptive activity goals versus daily adaptive activity goals on weight change over time (from baseline to 3 months).||0.18|-1.01|0.17
72366920|NCT04922216|144244662|SUPERIORITY||Mean Difference (Net)|0.53||||0.08|TWO_SIDED|95.0|-0.06|1.13|||Mixed Models Analysis|DF (2,622)|Fixed message decision points coded as 0 (reference) and adaptive message decision points coded as 1; a positive estimation parameter indicates that the reference group had greater (more negative) weight loss.|ITT analysis for factor 3 (message decision points) using linear mixed models comparing the effect of weekly adaptive activity goals versus daily adaptive activity goals on weight change over time (from baseline to 3 months).||1.13|-0.06|0.08
72366921|NCT04922216|144244662|SUPERIORITY||Mean Difference (Net)|0.32||||0.58|TWO_SIDED|95.0|-0.28|0.91|||Mixed Models Analysis|DF (2,622)|Standard decision rules coded as 0 (reference) and adaptive decision rules coded as 1; a positive estimation parameter indicates that the reference group had greater (more negative) weight loss.|ITT analysis for factor 4 (message decision rules) using linear mixed models comparing the effect of standard decision rules to adaptive decision rules on weight change over time (from baseline to 3 months).||0.91|-0.28|0.58
72366922|NCT04922216|144244662|SUPERIORITY||Mean Difference (Net)|-0.32||||0.55|TWO_SIDED|95.0|-0.91|0.28|||Mixed Models Analysis|DF (2,622)|No choice points coded as 0 (reference) and Choice coded as 1; a positive estimation parameter indicates that the reference group had greater (more negative) weight loss.|ITT analysis for factor 5 (participant choice) using linear mixed models comparing the effect of no participant message choice versus participant message choice on weight change over time (from baseline to 3 months).||0.28|-0.91|0.55
72366923|NCT04922216|144244663|SUPERIORITY||Odds Ratio (OR)|0.99||||0.95|TWO_SIDED|95.0|0.7|1.39|||Chi-squared|DF (1)|Standard dietary monitoring coded as 0 (reference) and simplified dietary monitoring coded as 1; an odds ratio \> 1 indicates that the odds of achieving 5% weight loss are higher in the group coded as 1.|Chi-square test of the difference in proportion reaching 5% weight loss from baseline to 6 months between standard dietary monitoring and simplified dietary monitoring (factor 1).||1.39|0.70|0.95
72366924|NCT04922216|144244663|SUPERIORITY||Odds Ratio (OR)|1.46||||0.03|TWO_SIDED|95.0|1.03|2.05|||Chi-squared|DF (1)|Weekly adaptive activity goals coded as 0 (reference) and daily adaptive activity goals coded as 1; an odds ratio \> 1 indicates that the odds of achieving 5% weight loss are higher in the group coded as 1.|Chi-square test of the difference in proportion reaching 5% weight loss from baseline to 6 months between weekly adaptive activity goals and daily adaptive activity goals (factor 2).||2.05|1.03|0.03
72366925|NCT04922216|144244663|SUPERIORITY||Odds Ratio (OR)|0.85||||0.36|TWO_SIDED|95.0|0.6|1.2|||Chi-squared|DF (1)|Fixed decision points coded as 0 (reference) and adaptive decision points coded as 1; an odds ratio \> 1 indicates that the odds of achieving 5% weight loss are higher in the group coded as 1.|Chi-square test of the difference in proportion reaching 5% weight loss from baseline to 6 months between fixed message decision points and adaptive message decision points (factor 3).||1.20|0.60|0.36
72366926|NCT04922216|144244663|SUPERIORITY||Odds Ratio (OR)|1.01||||0.95|TWO_SIDED|95.0|0.72|1.42|||Chi-squared|DF (1)|Standard decision rules coded as 0 (reference) and adaptive decision rules coded as 1; an odds ratio \> 1 indicates that the odds of achieving 5% weight loss are higher in the group coded as 1.|Chi-square test of the difference in proportion reaching 5% weight loss from baseline to 6 months between standard message decision rules and adaptive message decision rules (factor 4).||1.42|0.72|0.95
72366927|NCT04922216|144244663|SUPERIORITY||Odds Ratio (OR)|1.2||||0.29|TWO_SIDED|95.0|0.85|1.69|||Chi-squared|DF (1)|No message choice coded as 0 (reference) and message choice coded as 1; an odds ratio \> 1 indicates that the odds of achieving 5% weight loss are higher in the group coded as 1.|Chi-square test of the difference in proportion reaching 5% weight loss from baseline to 6 months between no message choice and message choice (factor 5).||1.69|0.85|0.29
72366928|NCT04145349|144244745|SUPERIORITY||Posterior Mean Hazard Ratio|0.69|||||TWO_SIDED|98.0|0.25|1.69|||Bayesian hierarchical model|||The Bayesian analyses below include posterior mean of Hazard ratio, and credible intervals instead of confidence intervals.|The posterior probability treatment difference is 0.864|1.69|0.25|
72366929|NCT01148979|144244752|OTHER|A Paired sample t-test was used to test the null hypothesis of no difference in MDAR score change after 4 weeks of treatment with Vyvanse versus placebo.|||||<|0.05|TWO_SIDED|95.0|||||t-test, 2 sided|||The statistical analysis represents a within-subject comparison of change under treatment with Vyvanse versus change under treatment with placebo, using paired t-tests with each subject as their own control. All tests reported are two-tailed.||||<0.05
72366930|NCT00865566|144244775|OTHER|Score test|Hazard Ratio (HR)|0.73|||<|0.001|TWO_SIDED|95.0|0.63|0.84|||Regression, Cox||HR is vaccine / placebo|Cox proportional hazards model to assess the association between treatment assignment and dropout||0.84|0.63|<0.001
72366931|NCT00865566|144244776|OTHER||Hazard Ratio (HR)|0.77||||0.05|TWO_SIDED|95.0|0.59|1.0||Score test|Regression, Cox||HR is vaccine / placebo|Cox PH model to assess the association between treatment assignment and dropout||1|0.59|0.05
72366932|NCT00865566|144244777|OTHER||Cox Proportional Hazard|0.71|||<|0.001|TWO_SIDED|95.0|0.6|0.84||Score test|Regression, Cox||HR is vaccine / placebo|Assess the association between treatment assignment and dropout||0.84|0.60|<0.001
72366933|NCT00865566|144244778|OTHER||Hazard Ratio (HR)|1.02||||0.903|TWO_SIDED|95.0|0.73|1.42||Score test|Regression, Cox|Adjusted for age, behavioral risk score, square of behavioral risk score, race, and BMI|HR is vaccine / placebo|||1.42|0.73|0.903
72366934|NCT00865566|144244779|OTHER||Hazard Ratio (HR)|1.06||||0.783|TWO_SIDED|95.0|0.71|1.58||Adjusted for ave, behavioral risk score, square of behavioral risk score, and BMI|Regression, Cox|Score test|HR is vaccine / placebo|||1.58|0.71|0.783
72366935|NCT03847896|144244823|SUPERIORITY||Mean Difference (Final Values)|60.5||||0.025|TWO_SIDED|95.0|7.7|113.4|||ANCOVA|||Only includes data from date of first dose up to date of last dose of randomized treatment. A sequential testing strategy is used such that the primary hypothesis tests are listed in ascending order of sequence. A null hypothesis can only be rejected if all preceding null hypotheses are also rejected. Tests are each conducted at the 5% level of significance.||113.4|7.7|0.025
72366936|NCT03847896|144244823|SUPERIORITY||Mean Difference (Final Values)|161.9|||<|0.001|TWO_SIDED|95.0|109.4|214.5|||ANCOVA|||Only includes data from date of first dose up to date of last dose of randomized treatment. A sequential testing strategy is used such that the primary hypothesis tests are listed in ascending order of sequence. A null hypothesis can only be rejected if all preceding null hypotheses are also rejected. Tests are each conducted at the 5% level of significance.||214.5|109.4|<0.001
72366937|NCT03847896|144244823|SUPERIORITY||Mean Difference (Final Values)|80.7||||0.003|TWO_SIDED|95.0|28.4|132.9|||ANCOVA|||Only includes data from date of first dose up to date of last dose of randomized treatment. A sequential testing strategy is used such that the primary hypothesis tests are listed in ascending order of sequence. A null hypothesis can only be rejected if all preceding null hypotheses are also rejected. Tests are each conducted at the 5% level of significance.||132.9|28.4|0.003
72366938|NCT03847896|144244824|SUPERIORITY||Mean Difference (Final Values)|73.3||||0.037|TWO_SIDED|95.0|4.4|142.2|||ANCOVA|||Only includes data from date of first dose up to date of last dose of randomized treatment. A sequential testing strategy is used such that the primary hypothesis tests are listed in ascending order of sequence. A null hypothesis can only be rejected if all preceding null hypotheses are also rejected. Tests are each conducted at the 5% level of significance.||142.2|4.4|0.037
72366939|NCT03847896|144244824|SUPERIORITY||Mean Difference (Final Values)|99.9||||0.005|TWO_SIDED|95.0|30.9|168.8|||ANCOVA|||Only includes data from date of first dose up to date of last dose of randomized treatment. A sequential testing strategy is used such that the primary hypothesis tests are listed in ascending order of sequence. A null hypothesis can only be rejected if all preceding null hypotheses are also rejected. Tests are each conducted at the 5% level of significance.||168.8|30.9|0.005
72366940|NCT03847896|144244824|SUPERIORITY||Mean Difference (Final Values)|132.8|||<|0.001|TWO_SIDED|95.0|63.6|201.9|||ANCOVA|||Only includes data from date of first dose up to date of last dose of randomized treatment. A sequential testing strategy is used such that the primary hypothesis tests are listed in ascending order of sequence. A null hypothesis can only be rejected if all preceding null hypotheses are also rejected. Tests are each conducted at the 5% level of significance.||201.9|63.6|<0.001
72366941|NCT03847896|144244824|SUPERIORITY||Mean Difference (Final Values)|87.9||||0.013|TWO_SIDED|95.0|18.8|156.9|||ANCOVA|||Only includes data from date of first dose up to date of last dose of randomized treatment. A sequential testing strategy is used such that the primary hypothesis tests are listed in ascending order of sequence. A null hypothesis can only be rejected if all preceding null hypotheses are also rejected. Tests are each conducted at the 5% level of significance.||156.9|18.8|0.013
72366942|NCT03847896|144244824|SUPERIORITY||Mean Difference (Final Values)|120.8|||<|0.001|TWO_SIDED|95.0|51.5|190.1|||ANCOVA|||Only includes data from date of first dose up to date of last dose of randomized treatment. A sequential testing strategy is used such that the primary hypothesis tests are listed in ascending order of sequence. A null hypothesis can only be rejected if all preceding null hypotheses are also rejected. Tests are each conducted at the 5% level of significance.||190.1|51.5|<0.001
72366943|NCT03847896|144244825|SUPERIORITY||Median Difference (Final Values)|-2.5|||||TWO_SIDED|95.0|-6.0|1.0||||||Not type-I error controlled. The estimated median difference and 95% CIs are calculated using the Hodges-Lehmann method.||1|-6|
72366944|NCT03847896|144244825|SUPERIORITY||Median Difference (Final Values)|3.0|||||TWO_SIDED|95.0|-3.0|9.0||||||Not type-I error controlled. The estimated median difference and 95% CIs are calculated using the Hodges-Lehmann method.||9|-3|
72366945|NCT03847896|144244825|SUPERIORITY||Median Difference (Final Values)|-4.5|||||TWO_SIDED|95.0|-9.0|0.0||||||Not type-I error controlled. The estimated median difference and 95% CIs are calculated using the Hodges-Lehmann method.||0|-9|
72366946|NCT03847896|144244825|SUPERIORITY||Median Difference (Final Values)|-4.5|||||TWO_SIDED|95.0|-9.0|0.0||||||Not type-I error controlled. The estimated median difference and 95% CIs are calculated using the Hodges-Lehmann method.||0|-9|
72366947|NCT03847896|144244825|SUPERIORITY||Median Difference (Final Values)|-1.5|||||TWO_SIDED|95.0|-3.0|0.0||||||Not type-I error controlled. The estimated median difference and 95% CIs are calculated using the Hodges-Lehmann method.||0|-3|
72366948|NCT03847896|144244825|SUPERIORITY||Median Difference (Final Values)|-1.0|||||TWO_SIDED|95.0|-2.0|0.0||||||Not type-I error controlled. The estimated median difference and 95% CIs are calculated using the Hodges-Lehmann method.||0|-2|
72366949|NCT03847896|144244825|SUPERIORITY||Median Difference (Final Values)|-6.5|||||TWO_SIDED|95.0|-11.0|-2.0||||||Not type-I error controlled. The estimated median difference and 95% CIs are calculated using the Hodges-Lehmann method.||-2|-11|
72366950|NCT03847896|144244825|SUPERIORITY||Median Difference (Final Values)|-6.5|||||TWO_SIDED|95.0|-11.0|-2.0||||||Not type-I error controlled. The estimated median difference and 95% CIs are calculated using the Hodges-Lehmann method.||-2|-11|
72366951|NCT03847896|144244825|SUPERIORITY||Median Difference (Final Values)|0.0|||||TWO_SIDED|95.0|-1.0|1.0||||||Not type-I error controlled. The estimated median difference and 95% CIs are calculated using the Hodges-Lehmann method.||1|-1|
72366952|NCT03847896|144244827|SUPERIORITY||Odds Ratio (OR)|0.699||||0.118|TWO_SIDED|95.0|0.445|1.096|||Regression, Logistic|||Comparison is not type-I error controlled.||1.096|0.445|0.118
72366953|NCT03847896|144244827|SUPERIORITY||Odds Ratio (OR)|1.386||||0.161|TWO_SIDED|95.0|0.878|2.187|||Regression, Logistic|||Comparison is not type-I error controlled.||2.187|0.878|0.161
72366954|NCT03847896|144244827|SUPERIORITY||Odds Ratio (OR)|1.605||||0.044|TWO_SIDED|95.0|1.013|2.541|||Regression, Logistic|||Comparison is not type-I error controlled.||2.541|1.013|0.044
72366955|NCT03847896|144244827|SUPERIORITY||Odds Ratio (OR)|1.626||||0.039|TWO_SIDED|95.0|1.024|2.584|||Regression, Logistic|||Comparison is not type-I error controlled.||2.584|1.024|0.039
72366956|NCT03847896|144244827|SUPERIORITY||Odds Ratio (OR)|2.297|||<|0.001|TWO_SIDED|95.0|1.456|3.626|||Regression, Logistic|||Comparison is not type-I error controlled.||3.626|1.456|<0.001
72366957|NCT03847896|144244827|SUPERIORITY||Odds Ratio (OR)|2.328|||<|0.001|TWO_SIDED|95.0|1.471|3.687|||Regression, Logistic|||Comparison is not type-I error controlled.||3.687|1.471|<0.001
72366958|NCT03847896|144244827|SUPERIORITY||Odds Ratio (OR)|1.158||||0.532|TWO_SIDED|95.0|0.731|1.835|||Regression, Logistic|||Comparison is not type-I error controlled.||1.835|0.731|0.532
72366959|NCT03847896|144244827|SUPERIORITY||Odds Ratio (OR)|1.174||||0.499|TWO_SIDED|95.0|0.737|1.868|||Regression, Logistic|||Comparison is not type-I error controlled.||1.868|0.737|0.499
72366960|NCT03847896|144244827|SUPERIORITY||Odds Ratio (OR)|1.014||||0.955|TWO_SIDED|95.0|0.635|1.618|||Regression, Logistic|||Comparison is not type-I error controlled.||1.618|0.635|0.955
72366961|NCT03847896|144244828|SUPERIORITY||Mean Difference (Final Values)|-42.1||||0.169|TWO_SIDED|95.0|-101.9|17.8|||ANCOVA|||Comparison is not type-I error controlled.||17.8|-101.9|0.169
72366962|NCT03847896|144244828|SUPERIORITY||Mean Difference (Final Values)|52.1||||0.086|TWO_SIDED|95.0|-7.4|111.5|||ANCOVA|||Comparison is not type-I error controlled.||111.5|-7.4|0.086
72366963|NCT03847896|144244828|SUPERIORITY||Mean Difference (Final Values)|30.7||||0.31|TWO_SIDED|95.0|-28.6|90.1|||ANCOVA|||Comparison is not type-I error controlled.||90.1|-28.6|0.31
72366964|NCT03847896|144244828|SUPERIORITY||Mean Difference (Final Values)|65.9||||0.03|TWO_SIDED|95.0|6.3|125.4|||ANCOVA|||Comparison is not type-I error controlled.||125.4|6.3|0.03
72366965|NCT03847896|144244828|SUPERIORITY||Mean Difference (Final Values)|72.8||||0.017|TWO_SIDED|95.0|13.1|132.5|||ANCOVA|||Comparison is not type-I error controlled.||132.5|13.1|0.017
72366966|NCT03847896|144244828|SUPERIORITY||Mean Difference (Final Values)|107.9|||<|0.001|TWO_SIDED|95.0|48.1|167.8|||ANCOVA|||Comparison is not type-I error controlled.||167.8|48.1|<0.001
72366967|NCT03847896|144244828|SUPERIORITY||Mean Difference (Final Values)|-21.3||||0.48|TWO_SIDED|95.0|-80.5|37.9|||ANCOVA|||Comparison is not type-I error controlled.||37.9|-80.5|0.48
72366968|NCT03847896|144244828|SUPERIORITY||Mean Difference (Final Values)|13.8||||0.648|TWO_SIDED|95.0|-45.6|73.2|||ANCOVA|||Comparison is not type-I error controlled.||73.2|-45.6|0.648
72366969|NCT03847896|144244828|SUPERIORITY||Mean Difference (Final Values)|35.1||||0.246|TWO_SIDED|95.0|-24.2|94.5|||ANCOVA|||Comparison is not type-I error controlled.||94.5|-24.2|0.246
72366970|NCT02978781|144244830|SUPERIORITY||Least Squares Mean Difference|0.02|STANDARD_ERROR_OF_MEAN|0.227||0.9143|TWO_SIDED|95.0|-0.44|0.49|||Mixed Model for Repeated Measures (MMRM)||Least squares mean difference from Randomization (SAGE-217 - placebo)|Change from Randomization at Day 14 (predose)|MMRM model was used for analysis with change from randomization of the Kinesia kinetic tremor combined scores as the dependent variable, treatment group by study visit/time point interaction as fixed effects, and randomization value as a covariate.|0.49|-0.44|0.9143
72366971|NCT02978781|144244831|OTHER||Least Squares Mean Difference|-1.74|STANDARD_ERROR_OF_MEAN|0.815||0.0529|TWO_SIDED|95.0|-3.5|0.03|||Mixed Model for Repeated Measures (MMRM)||Least squares mean difference from Baseline (SAGE-217)|Change from Baseline at Day 15|MMRM model was used for analysis with change from randomization of the Kinesia kinetic tremor combined scores as the dependent variable, treatment group by study visit/time point interaction as fixed effects, and randomization value as a covariate.|0.03|-3.50|0.0529
72366972|NCT02978781|144244837|SUPERIORITY||Least Squares Mean Difference|-0.38|STANDARD_ERROR_OF_MEAN|1.326||0.7795|TWO_SIDED|95.0|-3.47|2.7|||Mixed Model for Repeated Measures (MMRM)||Least squares mean difference from Randomization (SAGE-217 - placebo)|Change from Randomization at Day 14|MMRM model was used for analysis with change from randomization of the Kinesia kinetic tremor combined scores as the dependent variable, treatment group by study visit/time point interaction as fixed effects, and randomization value as a covariate.|2.70|-3.47|0.7795
72366973|NCT02978781|144244838|SUPERIORITY||Least Squares Mean Difference|0.34|STANDARD_ERROR_OF_MEAN|0.473||0.4846|TWO_SIDED|95.0|-0.65|1.33|||Mixed Model for Repeated Measures (MMRM)||Least squares mean difference from Randomization (SAGE-217 - placebo)|Change from Randomization in Forward outstretched postural tremor (FOPT) at Day 14|MMRM model was used for analysis with change from randomization of the Kinesia kinetic tremor combined scores as the dependent variable, treatment group by study visit/time point interaction as fixed effects, and randomization value as a covariate.|1.33|-0.65|0.4846
72366974|NCT02978781|144244838|SUPERIORITY||Least Squares Mean Difference|-0.67|STANDARD_ERROR_OF_MEAN|0.845||0.4567|TWO_SIDED|95.0|-2.7|1.36|||Mixed Model for Repeated Measures (MMRM)||Least squares mean difference from Randomization (SAGE-217 - placebo)|"Change from Randomization in Lateral wing beating postural tremor (LWBPT) at Day 14"|MMRM model was used for analysis with change from randomization of the Kinesia kinetic tremor combined scores as the dependent variable, treatment group by study visit/time point interaction as fixed effects, and randomization value as a covariate.|1.36|-2.70|0.4567
72366975|NCT02978781|144244839|SUPERIORITY||Least Squares Mean Difference|-0.76|STANDARD_ERROR_OF_MEAN|0.85||0.3771|TWO_SIDED|95.0|-2.48|0.96|||Mixed Model for Repeated Measures (MMRM)||Least squares mean difference from Randomization (SAGE-217 - placebo)|Change from Randomization at Day 14|MMRM model was used for analysis with change from randomization of the Kinesia kinetic tremor combined scores as the dependent variable, treatment group by study visit/time point interaction as fixed effects, and randomization value as a covariate.|0.96|-2.48|0.3771
72366976|NCT02978781|144244840|SUPERIORITY||Least Squares Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.415||0.7302|TWO_SIDED|95.0|-0.97|0.69|||Mixed Model for Repeated Measures (MMRM)||Least squares mean difference from Randomization (SAGE-217 - placebo)|Change from Randomization in Forward outstretched postural tremor (FOPT) at Day 14|MMRM model was used for analysis with change from randomization of the Kinesia kinetic tremor combined scores as the dependent variable, treatment group by study visit/time point interaction as fixed effects, and randomization value as a covariate.|0.69|-0.97|0.7302
72366977|NCT02978781|144244840|SUPERIORITY||Least Squares Mean Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.467||0.7916|TWO_SIDED|95.0|-1.1|0.85|||Mixed Model for Repeated Measures (MMRM)||Least squares mean difference from Randomization (SAGE-217 - placebo)|"Change from Randomization in Lateral wing beating postural tremor (LWBPT) at Day 14"|MMRM model was used for analysis with change from randomization of the Kinesia kinetic tremor combined scores as the dependent variable, treatment group by study visit/time point interaction as fixed effects, and randomization value as a covariate.|0.85|-1.10|0.7916
72366978|NCT02978781|144244841|SUPERIORITY||Least Squares Mean Difference|-0.47|STANDARD_ERROR_OF_MEAN|0.34||0.1807|TWO_SIDED|95.0|-1.17|0.23|||Mixed Model for Repeated Measures (MMRM)||Least squares mean difference from Randomization (SAGE-217 - placebo)|Change from Randomization at Day 14|MMRM model was used for analysis with change from randomization of the Kinesia kinetic tremor combined scores as the dependent variable, treatment group by study visit/time point interaction as fixed effects, and randomization value as a covariate.|0.23|-1.17|0.1807
72366979|NCT02978781|144244842|SUPERIORITY||Least Squares Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.72||0.8709|TWO_SIDED|95.0|-1.7|1.9|||Mixed Model for Repeated Measures (MMRM)||Least squares mean difference from Baseline(SAGE-217 - placebo)|Change from Baseline in Archimedes Spirals (AS) at Day 14|MMRM model was used for analysis with change from randomization of the Kinesia kinetic tremor combined scores as the dependent variable, treatment group by study visit/time point interaction as fixed effects, and randomization value as a covariate.|1.9|-1.7|0.8709
72366980|NCT02978781|144244842|SUPERIORITY||Least Squares Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.65||0.7843|TWO_SIDED|95.0|-1.8|1.4|||Mixed Model for Repeated Measures (MMRM)||Least squares mean difference from Baseline (SAGE-217 - placebo)|Change from Baseline in Handwriting at Day 14|MMRM model was used for analysis with change from randomization of the Kinesia kinetic tremor combined scores as the dependent variable, treatment group by study visit/time point interaction as fixed effects, and randomization value as a covariate.|1.4|-1.8|0.7843
72366981|NCT02978781|144244842|SUPERIORITY||Least Squares Mean Difference|-0.31|STANDARD_ERROR_OF_MEAN|0.984||0.7604|TWO_SIDED|95.0|-2.72|2.1|||Mixed Model for Repeated Measures (MMRM)||Least squares mean difference from Baseline (SAGE-217 - placebo|Change from Baseline in Dot approximation task (DAT) at Day 14|MMRM model was used for analysis with change from randomization of the Kinesia kinetic tremor combined scores as the dependent variable, treatment group by study visit/time point interaction as fixed effects, and randomization value as a covariate.|2.10|-2.72|0.7604
72366982|NCT02978781|144244843|OTHER||Least Squares Mean Difference|-0.48|STANDARD_ERROR_OF_MEAN|0.301||0.1333|TWO_SIDED|95.0|-1.13|0.17|||Mixed Model for Repeated Measures (MMRM)||Least squares mean difference from Baseline (SAGE-217)|Change from Baseline in Forward outstretched postural tremor (FOPT) at Day 15|MMRM model was used for analysis with change from randomization of the Kinesia kinetic tremor combined scores as the dependent variable, treatment group by study visit/time point interaction as fixed effects, and randomization value as a covariate.|0.17|-1.13|0.1333
72366983|NCT02978781|144244843|OTHER||Least Squares Mean Difference|-0.81|STANDARD_ERROR_OF_MEAN|0.389||0.0572|TWO_SIDED|95.0|-1.64|0.03|||Mixed Model for Repeated Measures (MMRM)||Least squares mean difference from Baseline (SAGE-217)|"Change from Baseline in Lateral wing beating postural tremor (LWBPT) at Day 15"|MMRM model was used for analysis with change from randomization of the Kinesia kinetic tremor combined scores as the dependent variable, treatment group by study visit/time point interaction as fixed effects, and randomization value as a covariate.|0.03|-1.64|0.0572
72366984|NCT02978781|144244843|OTHER||Least Squares Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.255||0.0707|TWO_SIDED|95.0|-1.05|0.05|||Mixed Model for Repeated Measures (MMRM)||Least squares mean difference from Baseline (SAGE-217)|Change from Baseline in Kinetic tremor (KT) at Day 15|MMRM model was used for analysis with change from randomization of the Kinesia kinetic tremor combined scores as the dependent variable, treatment group by study visit/time point interaction as fixed effects, and randomization value as a covariate.|0.05|-1.05|0.0707
72366985|NCT02978781|144244844|OTHER||Least Squares Mean Difference|-1.53|STANDARD_ERROR_OF_MEAN|0.628||0.0278|TWO_SIDED|95.0|-2.87|-0.19|||Mixed Model for Repeated Measures (MMRM)||Least squares mean difference from Baseline (SAGE-217)|Change from Baseline at Day 15|MMRM model was used for analysis with change from randomization of the Kinesia kinetic tremor combined scores as the dependent variable, treatment group by study visit/time point interaction as fixed effects, and randomization value as a covariate.|-0.19|-2.87|0.0278
72368815|NCT02637037|144247321|NON_INFERIORITY_OR_EQUIVALENCE|If the 90% CIs for both dapagliflozin and metformin geometric mean ratio of AUC is entirely contained within an 80.00% to 125.00% interval, it will be concluded the 2 manufacturing sites are bioequivalent.|Ratios of Geometric means|0.97|||||TWO_SIDED|90.0|0.89|1.05||||||Dapagliflozin: Statistical Assessment of Bioequivalence for Dapagliflozin following administration Dapagliflozin/Metformin XR 10/1000 mg for Treatment E and F.||1.05|0.89|
72366986|NCT02978781|144244845|OTHER||Least Squares Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.258||0.9579|TWO_SIDED|95.0|-0.57|0.54|||Mixed Model for Repeated Measures (MMRM)||Least squares mean difference from Baseline (SAGE-217)|Change from Baseline in Forward outstretched postural tremor (FOPT) at Day 15|MMRM model was used for analysis with change from randomization of the Kinesia kinetic tremor combined scores as the dependent variable, treatment group by study visit/time point interaction as fixed effects, and randomization value as a covariate.|0.54|-0.57|0.9579
72366987|NCT02978781|144244845|OTHER||Least Squares Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.234||0.0039|TWO_SIDED|95.0|-1.31|-0.3|||Mixed Model for Repeated Measures (MMRM)||Least squares mean difference from Baseline (SAGE-217)|"Change from Baseline in Lateral wing beating postural tremor (LWBPT) at Day 15"|MMRM model was used for analysis with change from randomization of the Kinesia kinetic tremor combined scores as the dependent variable, treatment group by study visit/time point interaction as fixed effects, and randomization value as a covariate.|-0.30|-1.31|0.0039
72366988|NCT02978781|144244845|OTHER||Least Squares Mean Difference|-0.67|STANDARD_ERROR_OF_MEAN|0.223||0.0099|TWO_SIDED|95.0|-1.14|-0.19|||Mixed Model for Repeated Measures (MMRM)||Least squares mean difference from Baseline (SAGE-217)|Change from Baseline in Kinetic tremor (KT) at Day 15|MMRM model was used for analysis with change from randomization of the Kinesia kinetic tremor combined scores as the dependent variable, treatment group by study visit/time point interaction as fixed effects, and randomization value as a covariate.|-0.19|-1.14|0.0099
72366989|NCT02978781|144244846|OTHER||Least Squares Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.41||0.1595|TWO_SIDED|95.0|-1.5|0.3|||Mixed Model for Repeated Measures (MMRM)||Least squares mean difference from Baseline (SAGE-217)|Change from Baseline in Archimedes spirals (AS) at Day 15|MMRM model was used for analysis with change from randomization of the Kinesia kinetic tremor combined scores as the dependent variable, treatment group by study visit/time point interaction as fixed effects, and randomization value as a covariate.|0.3|-1.5|0.1595
72366990|NCT02978781|144244846|OTHER||Least Squares Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.19||0.0126|TWO_SIDED|95.0|-0.9|-0.1|||Mixed Model for Repeated Measures (MMRM)||Least squares mean difference from Baseline (SAGE-217)|Change from Baseline in Handwriting at Day 15|MMRM model was used for analysis with change from randomization of the Kinesia kinetic tremor combined scores as the dependent variable, treatment group by study visit/time point interaction as fixed effects, and randomization value as a covariate.|-0.1|-0.9|0.0126
72366991|NCT02978781|144244846|OTHER||Least Squares Mean Difference|-0.23|STANDARD_ERROR_OF_MEAN|0.151||0.1536|TWO_SIDED|95.0|-0.55|0.1|||Mixed Model for Repeated Measures (MMRM)||Least squares mean difference from Baseline (SAGE-217)|Change from Baseline in Dot approximation task (DAT) at Day 15|MMRM model was used for analysis with change from randomization of the Kinesia kinetic tremor combined scores as the dependent variable, treatment group by study visit/time point interaction as fixed effects, and randomization value as a covariate.|0.10|-0.55|0.1536
72366992|NCT02453321|144244855|SUPERIORITY|||||||0.355|||||||Kruskal-Wallis|||||||0.355
72366993|NCT02453321|144244856|SUPERIORITY|||||||0.065|||||||Kruskal-Wallis|||||||0.065
72366994|NCT02350296|144244895|EQUIVALENCE|Acceptance criterion for bioequivalence was a 94.12% confidence interval for the test/reference ratio of the geometric means within the 80.00-125.00% range, according to the current guidelines for bioequivalence studies.|geometric means ratio|108.12||||0.1455|TWO_SIDED|94.12|97.57|119.81||"treatment P value reported"|ANOVA||Estimated value and limits are expressed in %|||119.81|97.57|0.1455
72366995|NCT02350296|144244896|EQUIVALENCE|Acceptance criterion for bioequivalence was a 94.12% confidence interval for the test/reference ratio of the geometric means within the 80.00-125.00% range, according to the current guidelines for bioequivalence studies.|geometric means ratio|110.62||||0.0023|TWO_SIDED|94.12|104.26|117.38||"Treatment P value is reported"|ANOVA||Estimated value and limits are expressed in %|||117.38|104.26|0.0023
72366996|NCT02350296|144244897|EQUIVALENCE|Acceptance criterion for bioequivalence was a 94.12% confidence interval for the test/reference ratio of the geometric means within the 80.00-125.00% range, according to the current guidelines for bioequivalence studies.|geometric means ratio|110.69||||0.0021|TWO_SIDED|94.12|104.35|117.41||"treatment P value is reported"|ANOVA||Estimated value and limits are expressed in %|||117.41|104.35|0.0021
72366997|NCT02350296|144244898|EQUIVALENCE|Acceptance criterion for bioequivalence was a 94.12% confidence interval for the test/reference ratio of the geometric means within the 80.00-125.00% range, according to the current guidelines for bioequivalence studies.||||||0.0201|||||||Friedman|||||||0.0201
72366998|NCT01544335|144244909|OTHER||||||<|0.001|||||||Correlation coefficient|The correlation between RVC and ΔL-Dex values was plotted, and the correlation strength was assessed using the Pearson correlation coefficient, r.||||||<0.001
72366999|NCT00363480|144244925|SUPERIORITY_OR_OTHER||Percentage diffrence|-30.6|||<|0.0001|TWO_SIDED|95.0|-37.89|-23.29|||McNemar|||Comparison between GOAL and ACT response||-23.29|-37.89|<0.0001
72367000|NCT00363480|144244926|SUPERIORITY_OR_OTHER||t-Distribution|50.2|||||TWO_SIDED|95.0|43.15|57.32||||||||57.32|43.15|
72367001|NCT01721044|144244948|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|||||||Regression, Logistic|If logistic regression sample size requirements are not met, the p-value from Fisher's exact test is used instead.||||||0.001
72367002|NCT01721044|144244949|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|||||||ANCOVA|||||||0.001
72367003|NCT01721044|144244950|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|||||||ANCOVA|||||||0.001
72367004|NCT01721044|144244951|SUPERIORITY_OR_OTHER_LEGACY|||||||0.14|||||||Regression, Logistic|If logistic regression sample size requirements are not met, the p-value from Fisher's exact test is used instead.||||||0.140
72367005|NCT01721044|144244952|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|||||||Regression, Logistic|If logistic regression sample size requirements are not met, the p-value from Fisher's exact test is used instead.||||||0.001
72367006|NCT01721044|144244953|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|||||||ANCOVA|||||||0.001
72367007|NCT01721044|144244954|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|||||||ANCOVA|||||||0.001
72367008|NCT01721044|144244955|SUPERIORITY_OR_OTHER_LEGACY|||||||0.723|||||||Regression, Logistic|If logistic regression sample size requirements are not met, the p-value from Fisher's exact test is used instead.||||||0.723
72367009|NCT01721044|144244956|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|TWO_SIDED|||||a priori p-value significance threshold: 2-sided \<=0.05|Regression, Logistic|If logistic regression sample size requirements are not met, the p-value from Fisher's exact test is used instead.||||||0.001
72367010|NCT01721044|144244956|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|TWO_SIDED|||||a priori p-value significance threshold: 2-sided \<=0.05|Regression, Logistic|If logistic regression sample size requirements are not met, the p-value from Fisher's exact test is used instead.||||||0.001
72367011|NCT01721044|144244957|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|TWO_SIDED|||||a priori p-value significance threshold: 2-sided ≤0.05|Regression, Logistic|If logistic regression sample size requirements are not met, the p-value from Fisher's exact test is used instead.||Week 12||||0.001
72367012|NCT01721044|144244957|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002|TWO_SIDED|||||a priori p-value significance threshold: 2-sided ≤0.05|Regression, Logistic|If logistic regression sample size requirements are not met, the p-value from Fisher's exact test is used instead.||Week 12||||0.002
72367013|NCT01721044|144244957|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|TWO_SIDED|||||a priori p-value significance threshold: 2-sided ≤0.05|Regression, Logistic|If logistic regression sample size requirements are not met, the p-value from Fisher's exact test is used instead.||Week 24||||0.001
72367014|NCT01721044|144244957|SUPERIORITY_OR_OTHER_LEGACY|||||||0.015|TWO_SIDED|||||a priori p-value significance threshold: 2-sided ≤0.05|Regression, Logistic|If logistic regression sample size requirements are not met, the p-value from Fisher's exact test is used instead.||Week 24||||0.015
72367015|NCT01721044|144244958|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002|TWO_SIDED|||||a priori p-value significance threshold: 2-sided ≤0.05|Regression, Logistic|If logistic regression sample size requirements are not met, the p-value from Fisher's exact test is used instead.||Week 12||||0.002
72367016|NCT01721044|144244958|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|TWO_SIDED|||||a priori p-value significance threshold: 2-sided ≤0.05|Regression, Logistic|If logistic regression sample size requirements are not met, the p-value from Fisher's exact test is used instead.||Week 12||||0.001
72367017|NCT01721044|144244958|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|TWO_SIDED|||||a priori p-value significance threshold: 2-sided ≤0.05|Regression, Logistic|If logistic regression sample size requirements are not met, the p-value from Fisher's exact test is used instead.||Week 24||||0.001
72367018|NCT01721044|144244958|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|TWO_SIDED|||||a priori p-value significance threshold: 2-sided ≤0.05|Regression, Logistic|If logistic regression sample size requirements are not met, the p-value from Fisher's exact test is used instead.||Week 24||||0.001
72367019|NCT01721044|144244959|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|TWO_SIDED|||||a priori p-value significance threshold: 2-sided ≤0.05|ANCOVA|||||||0.001
72367020|NCT01721044|144244959|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|TWO_SIDED|||||a priori p-value significance threshold: 2-sided ≤0.05|ANCOVA|||||||0.001
72367021|NCT01721044|144244960|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|TWO_SIDED|||||a priori p-value significance threshold: 2-sided ≤0.05|ANCOVA|||||||0.001
72367022|NCT01721044|144244960|SUPERIORITY_OR_OTHER_LEGACY|||||||0.009|TWO_SIDED|||||a priori p-value significance threshold: 2-sided ≤0.05|ANCOVA|||||||0.009
72367023|NCT01721044|144244961|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|TWO_SIDED|||||a priori p-value significance threshold: 2-sided ≤0.05|ANCOVA|||||||0.001
72367024|NCT01721044|144244961|SUPERIORITY_OR_OTHER_LEGACY|||||||0.003|TWO_SIDED|||||a priori p-value significance threshold: 2-sided ≤0.05|ANCOVA|||||||0.003
72367025|NCT01721044|144244962|SUPERIORITY_OR_OTHER_LEGACY|||||||0.012|TWO_SIDED|||||a priori p-value significance threshold: 2-sided ≤0.05|Regression, Logistic|If logistic regression sample size requirements are not met, the p-value from Fisher's exact test is used instead.||||||0.012
72367026|NCT01721044|144244962|SUPERIORITY_OR_OTHER_LEGACY|||||||0.104|TWO_SIDED|||||a priori p-value significance threshold: 2-sided ≤0.05|Regression, Logistic|If logistic regression sample size requirements are not met, the p-value from Fisher's exact test is used instead.||||||0.104
72367027|NCT01721044|144244963|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002|TWO_SIDED|||||a priori p-value significance threshold: 2-sided ≤0.05|Wilcoxon (Mann-Whitney)|||||||0.002
72367028|NCT01721044|144244963|SUPERIORITY_OR_OTHER_LEGACY|||||||0.004|TWO_SIDED|||||a priori p-value significance threshold: 2-sided ≤0.05|Wilcoxon (Mann-Whitney)|||||||0.004
72367029|NCT01721044|144244964|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|TWO_SIDED|||||a priori p-value significance threshold: 2-sided ≤0.05|ANCOVA|||||||0.001
72367030|NCT01721044|144244964|SUPERIORITY_OR_OTHER_LEGACY|||||||0.018|TWO_SIDED|||||a priori p-value significance threshold: 2-sided ≤0.05|ANCOVA|||||||0.018
72367031|NCT01721044|144244965|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|TWO_SIDED|||||a priori p-value significance threshold: 2-sided ≤0.05|ANCOVA|||||||0.001
72367032|NCT01721044|144244965|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|TWO_SIDED|||||a priori p-value significance threshold: 2-sided ≤0.05|ANCOVA|||||||0.001
72367033|NCT01721044|144244966|SUPERIORITY_OR_OTHER_LEGACY|||||||0.005|TWO_SIDED|||||a priori p-value significance threshold: 2-sided ≤0.05|ANCOVA|||Week 12||||0.005
72367034|NCT01721044|144244966|SUPERIORITY_OR_OTHER_LEGACY|||||||0.004|TWO_SIDED|||||a priori p-value significance threshold: 2-sided ≤0.05|ANCOVA|||Week 12||||0.004
72367035|NCT01721044|144244966|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002|TWO_SIDED|||||a priori p-value significance threshold: 2-sided ≤0.05|ANCOVA|||Week 24||||0.002
72367036|NCT01721044|144244966|SUPERIORITY_OR_OTHER_LEGACY|||||||0.026|TWO_SIDED|||||a priori p-value significance threshold: 2-sided ≤0.05|ANCOVA|||Week 24||||0.026
72367037|NCT01721044|144244967|SUPERIORITY_OR_OTHER_LEGACY|||||||0.448|TWO_SIDED||||||ANCOVA|||MCS Week 12||||0.448
72367038|NCT01721044|144244967|SUPERIORITY_OR_OTHER_LEGACY|||||||0.058|TWO_SIDED||||||ANCOVA|||MCS Week 12||||0.058
72367039|NCT01721044|144244967|SUPERIORITY_OR_OTHER_LEGACY|||||||0.446|TWO_SIDED||||||ANCOVA|||MCS Week 24||||0.446
72367040|NCT01721044|144244967|SUPERIORITY_OR_OTHER_LEGACY|||||||0.401|TWO_SIDED||||||ANCOVA|||MCS Week 24||||0.401
72367041|NCT01721044|144244967|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|TWO_SIDED||||||ANCOVA|||PCS Week 12||||0.001
72367042|NCT01721044|144244967|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|TWO_SIDED||||||ANCOVA|||PCS Week 12||||0.001
72367043|NCT01721044|144244967|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|TWO_SIDED||||||ANCOVA|||PCS Week 24||||0.001
72367044|NCT01721044|144244967|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|TWO_SIDED||||||ANCOVA|||PCS Week 24||||0.001
72367045|NCT01721044|144244968|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|TWO_SIDED|||||a priori p-value significance threshold: 2-sided ≤0.05|ANCOVA|||Week 12, US Algorithm||||0.001
72367046|NCT01721044|144244968|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|TWO_SIDED|||||a priori p-value significance threshold: 2-sided ≤0.05|ANCOVA|||Week 12, US Algorithm||||0.001
72367047|NCT01721044|144244968|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|TWO_SIDED|||||a priori p-value significance threshold: 2-sided ≤0.05|ANCOVA|||Week 24, US Algorithm||||0.001
72367048|NCT01721044|144244968|SUPERIORITY_OR_OTHER_LEGACY|||||||0.003|TWO_SIDED|||||a priori p-value significance threshold: 2-sided ≤0.05|ANCOVA|||Week 24, US Algorithm||||0.003
72367049|NCT01721044|144244968|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|TWO_SIDED|||||a priori p-value significance threshold: 2-sided ≤0.05|ANCOVA|||Week 12, UK Algorithm||||0.001
72367050|NCT01721044|144244968|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|TWO_SIDED|||||a priori p-value significance threshold: 2-sided ≤0.05|ANCOVA|||Week 12, UK Algorithm||||0.001
72367051|NCT01721044|144244968|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|TWO_SIDED|||||a priori p-value significance threshold: 2-sided ≤0.05|ANCOVA|||Week 24, UK Algorithm||||0.001
72367052|NCT01721044|144244968|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002|TWO_SIDED|||||a priori p-value significance threshold: 2-sided ≤0.05|ANCOVA|||Week 24, UK Algorithm||||0.002
72367053|NCT01721044|144244969|SUPERIORITY_OR_OTHER_LEGACY|||||||0.362|TWO_SIDED||||||ANCOVA|||Absenteeism Week 12||||0.362
72367054|NCT01721044|144244969|SUPERIORITY_OR_OTHER_LEGACY|||||||0.17|TWO_SIDED||||||ANCOVA|||Absenteeism Week 12||||0.170
72367055|NCT01721044|144244969|SUPERIORITY_OR_OTHER_LEGACY|||||||0.753|TWO_SIDED||||||ANCOVA|||Absenteeism Week 24||||0.753
72367056|NCT01721044|144244969|SUPERIORITY_OR_OTHER_LEGACY|||||||0.715|TWO_SIDED||||||ANCOVA|||Absenteeism Week 24||||0.715
72367057|NCT01721044|144244969|SUPERIORITY_OR_OTHER_LEGACY|||||||0.077|TWO_SIDED||||||ANCOVA|||Presenteeism Week 12||||0.077
72367058|NCT01721044|144244969|SUPERIORITY_OR_OTHER_LEGACY|||||||0.058|TWO_SIDED||||||ANCOVA|||Presenteeism Week 12||||0.058
72367059|NCT01721044|144244969|SUPERIORITY_OR_OTHER_LEGACY|||||||0.232|TWO_SIDED||||||ANCOVA|||Presenteeism Week 24||||0.232
72367060|NCT01721044|144244969|SUPERIORITY_OR_OTHER_LEGACY|||||||0.534|TWO_SIDED||||||ANCOVA|||Presenteeism Week 24||||0.534
72367061|NCT01721044|144244969|SUPERIORITY_OR_OTHER_LEGACY|||||||0.079|TWO_SIDED||||||ANCOVA|||Work Productivity Loss Week 12||||0.079
72367062|NCT01721044|144244969|SUPERIORITY_OR_OTHER_LEGACY|||||||0.07|TWO_SIDED||||||ANCOVA|||Work Productivity Loss Week 12||||0.070
72367063|NCT01721044|144244969|SUPERIORITY_OR_OTHER_LEGACY|||||||0.327|TWO_SIDED||||||ANCOVA|||Work Productivity Loss Week 24||||0.327
72367064|NCT01721044|144244969|SUPERIORITY_OR_OTHER_LEGACY|||||||0.479|TWO_SIDED||||||ANCOVA|||Work Productivity Loss Week 24||||0.479
72367065|NCT01721044|144244969|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|TWO_SIDED||||||ANCOVA|||Activity Impairment Week 12||||0.001
72367066|NCT01721044|144244969|SUPERIORITY_OR_OTHER_LEGACY|||||||0.005|TWO_SIDED||||||ANCOVA|||Activity Impairment Week 12||||0.005
72367067|NCT01721044|144244969|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|TWO_SIDED||||||ANCOVA|||Activity Impairment Week 24||||0.001
72367068|NCT01721044|144244969|SUPERIORITY_OR_OTHER_LEGACY|||||||0.03|TWO_SIDED||||||ANCOVA|||Activity Impairment Week 24||||0.030
72367069|NCT04032093|144244980|OTHER||Geometric Mean Ratio|1.1|||||TWO_SIDED|95.0|0.9|1.3|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|A 50%: Before vaccination||1.3|0.9|
72367070|NCT04032093|144244980|OTHER||Geometric Mean Ratio|20.0|||||TWO_SIDED|95.0|16.1|24.7|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|A 50%: 2 Weeks after vaccination||24.7|16.1|
72367071|NCT04032093|144244980|OTHER||Geometric Mean Ratio|15.6|||||TWO_SIDED|95.0|11.9|20.4|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|A 50%: 1 Month after vaccination||20.4|11.9|
72367072|NCT04032093|144244980|OTHER||Geometric Mean Ratio|11.2|||||TWO_SIDED|95.0|8.7|14.5|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|A 50%: At delivery||14.5|8.7|
72367073|NCT04032093|144244980|OTHER||Geometric Mean Ratio|1.1|||||TWO_SIDED|95.0|0.9|1.3|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|B 50%: Before vaccination||1.3|0.9|
72367074|NCT04032093|144244980|OTHER||Geometric Mean Ratio|24.2|||||TWO_SIDED|95.0|18.5|31.7|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|B 50%: 2 Weeks after vaccination||31.7|18.5|
72367075|NCT04032093|144244980|OTHER||Geometric Mean Ratio|20.4|||||TWO_SIDED|95.0|15.7|26.6|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|B 50%: 1 Month after vaccination||26.6|15.7|
72367076|NCT04032093|144244980|OTHER||Geometric Mean Ratio|13.6|||||TWO_SIDED|95.0|10.1|18.4|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|B 50%: At delivery||18.4|10.1|
72367077|NCT04032093|144244980|OTHER||Geometric Mean Ratio|1.1|||||TWO_SIDED|95.0|0.9|1.3|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|A 50%: Before vaccination||1.3|0.9|
72367078|NCT04032093|144244980|OTHER||Geometric Mean Ratio|19.8|||||TWO_SIDED|95.0|15.3|25.7|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|A 50%: 2 Weeks after vaccination||25.7|15.3|
72367079|NCT04032093|144244980|OTHER||Geometric Mean Ratio|20.0|||||TWO_SIDED|95.0|15.9|25.1|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|A 50%: 1 Month after vaccination||25.1|15.9|
72367080|NCT04032093|144244980|OTHER||Geometric Mean Ratio|15.0|||||TWO_SIDED|95.0|11.9|18.9|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|A 50%: At delivery||18.9|11.9|
72367081|NCT04032093|144244980|OTHER||Geometric Mean Ratio|1.1|||||TWO_SIDED|95.0|0.8|1.3|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|B 50%: Before vaccination||1.3|0.8|
72367082|NCT04032093|144244980|OTHER||Geometric Mean Ratio|22.5|||||TWO_SIDED|95.0|16.9|30.1|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|B 50%: 2 Weeks after vaccination||30.1|16.9|
72367083|NCT04032093|144244980|OTHER||Geometric Mean Ratio|22.5|||||TWO_SIDED|95.0|17.6|28.7|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|B 50%: 1 Month after vaccination||28.7|17.6|
72367084|NCT04032093|144244980|OTHER||Geometric Mean Ratio|16.8|||||TWO_SIDED|95.0|12.7|22.3|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|B 50%: At delivery||22.3|12.7|
72367085|NCT04032093|144244980|OTHER||Geometric Mean Ratio|1.0|||||TWO_SIDED|95.0|0.8|1.2|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|A 50%: Before vaccination||1.2|0.8|
72367086|NCT04032093|144244980|OTHER||Geometric Mean Ratio|21.0|||||TWO_SIDED|95.0|16.6|26.5|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|A 50%: 2 Weeks after vaccination||26.5|16.6|
72367087|NCT04032093|144244980|OTHER||Geometric Mean Ratio|15.3|||||TWO_SIDED|95.0|11.6|20.1|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|A 50%: 1 Month after vaccination||20.1|11.6|
72367088|NCT04032093|144244980|OTHER||Geometric Mean Ratio|10.6|||||TWO_SIDED|95.0|8.1|14.0|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|A 50%: At delivery||14.0|8.1|
72367089|NCT04032093|144244980|OTHER||Geometric Mean Ratio|1.0|||||TWO_SIDED|95.0|0.8|1.3|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|B 50%: Before vaccination||1.3|0.8|
72367090|NCT04032093|144244980|OTHER||Geometric Mean Ratio|26.6|||||TWO_SIDED|95.0|20.5|34.6|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|B 50%: 2 Weeks after vaccination||34.6|20.5|
72367091|NCT04032093|144244980|OTHER||Geometric Mean Ratio|18.0|||||TWO_SIDED|95.0|13.5|24.1|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|B 50%: 1 Month after vaccination||24.1|13.5|
72367092|NCT04032093|144244980|OTHER||Geometric Mean Ratio|13.5|||||TWO_SIDED|95.0|10.1|18.0|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|B 50%: At delivery||18.0|10.1|
72367093|NCT04032093|144244980|OTHER||Geometric Mean Ratio|1.0|||||TWO_SIDED|95.0|0.9|1.3|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|A 50%: Before vaccination||1.3|0.9|
72367094|NCT04032093|144244980|OTHER||Geometric Mean Ratio|25.0|||||TWO_SIDED|95.0|19.9|31.3|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|A 50%: 2 Weeks after vaccination||31.3|19.9|
72367095|NCT04032093|144244980|OTHER||Geometric Mean Ratio|18.1|||||TWO_SIDED|95.0|14.5|22.8|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|A 50%: 1 Month after vaccination||22.8|14.5|
72367096|NCT04032093|144244980|OTHER||Geometric Mean Ratio|13.8|||||TWO_SIDED|95.0|10.8|17.5|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|A 50%: At delivery||17.5|10.8|
72367097|NCT04032093|144244980|OTHER||Geometric Mean Ratio|1.1|||||TWO_SIDED|95.0|0.9|1.4|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|B 50%: Before vaccination||1.4|0.9|
72367098|NCT04032093|144244980|OTHER||Geometric Mean Ratio|34.7|||||TWO_SIDED|95.0|27.0|44.4|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|B 50%: 2 Weeks after vaccination||44.4|27.0|
72367099|NCT04032093|144244980|OTHER||Geometric Mean Ratio|23.2|||||TWO_SIDED|95.0|18.2|29.6|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|B 50%: 1 Month after vaccination||29.6|18.2|
72367100|NCT04032093|144244980|OTHER||Geometric Mean Ratio|16.2|||||TWO_SIDED|95.0|12.0|21.7|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|B 50%: At delivery||21.7|12.0|
72367101|NCT04032093|144244982|OTHER||Geometric Mean Ratio|10.7|||||TWO_SIDED|95.0|8.1|14.1|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|A 50%: At birth||14.1|8.1|
72367102|NCT04032093|144244982|OTHER||Geometric Mean Ratio|8.9|||||TWO_SIDED|95.0|5.5|14.5|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|A 50%: 1 Month after birth||14.5|5.5|
72431783|NCT02851511|144375483|SUPERIORITY|tDCS vs. sham superiority with cognitive training will be tested based on the 320 participants who are assigned to the two cognitive training arms. The effects of tDCS on changes in NIH Toolbox Fluid Cognition Composite Score (NIHTB FCC) from baseline to 3-month follow-up are estimated by linear regression models, with missing outcomes predicted by regression models that include demographic and baseline characteristics.|Slope|0.33|STANDARD_ERROR_OF_MEAN|0.63|<|0.05|TWO_SIDED|95.0|-0.91|1.56||Formal statistical inference of the tDCS effect was based on the inverse-normal combination of two p-values, one from the Phase I data (N=42) and the other from the Phase II data (N=292).|Regression, Linear|||"Null hypothesis: The combination of cognitive training (12 weeks) and active stimulation (over the dorsolateral prefrontal cortex) will not lead to beneficial changes on the NIH Toolbox Cognition Battery.~The study is designed to have at least 90% power to detect a difference of effect size 0.42 between cognitive training+tDCS and cognitive training+sham, using a normal inverse combination test at one-sided 0.025 level."||1.56|-0.91|<0.05
72431784|NCT02584790|144375495|OTHER|||||||0.004|||||||Chi-squared|||2x2 table of: Row: 1. NBI suspicious pattern 2. NBI non-suspicious pattern Category: 1. with residual disease 2. without residual disease||||0.004
72431785|NCT00372567|144375511|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.04|||||TWO_SIDED|95.0|0.484|2.235|||Cox Proportional Hazards Model|Model stratified by previous imatinib treatment status (less than 6 months of treatment with imatinib and greater than or equal to 6 months).||No hypothesis tested.||2.235|0.484|
72431786|NCT00372567|144375512|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.818|||||TWO_SIDED|95.0|0.64|12.41|||Cox Proportional Hazards Model|Model stratified by previous imatinib treatment status (less than 6 months of treatment with imatinib and greater than or equal to 6 months).||||12.41|0.640|
72431787|NCT00372567|144375514|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.027|||||TWO_SIDED|95.0|0.505|2.088|||Cox Proportional Hazards Model|Model stratified by previous imatinib treatment status (less than 6 months of treatment with imatinib and greater than or equal to 6 months).||||2.088|0.505|
72431788|NCT00372567|144375515|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.308|||||TWO_SIDED|95.0|0.4|13.0|||Cochran-Mantel-Haenszel|Stratified by previous imatinib treatment status (less than 6 months of treatment with imatinib and greater than or equal to 6 months).||||13.0|0.4|
72431789|NCT00372567|144375518|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|3.434|||||TWO_SIDED|95.0|1.057|11.15|||Cox Proportional Hazards Model|Model stratified by previous imatinib treatment status (less than 6 months of treatment with imatinib and greater than or equal to 6 months).||||11.15|1.057|
72431790|NCT00372567|144375519|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.379|||||TWO_SIDED|95.0|0.1|2.3|||Cochran-Mantel-Haenszel|Stratified for previous imatinib treatment status (less than 6 months of treatment with imatinib and greater than or equal to 6 months).||||2.3|0.1|
72431791|NCT00372567|144375520|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.318|||||TWO_SIDED|95.0|0.5|3.8|||Cochran-Mantel-Haenszel|Stratified for previous imatinib treatment status (less than 6 months of treatment with imatinib and greater than or equal to 6 months).||||3.8|0.5|
72431792|NCT00958009|144375572|SUPERIORITY_OR_OTHER||mean positive response|0.86|||||TWO_SIDED|95.0|0.8|0.93|||||Confidence Interval calculated from normal approximation to the binomial. The primary objective was met if the lower bound of the 95% confidence interval is \>0.50.|||0.93|0.80|
72431793|NCT00558753|144375574|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.63||||0.003||95.0|||||t-test, 2 sided|||||||0.003
72431794|NCT00558753|144375575|SUPERIORITY_OR_OTHER||Independence: Chi-squared|10.3||||0.0013||95.0|||||Chi-squared|||For 3 month followup on incidence of neuropathic pain.||||0.0013
72431795|NCT00558753|144375575|SUPERIORITY_OR_OTHER||Independence: Chi-squared|6.05||||0.0139|||||||Chi-squared|||For 6 month followup on incidence of neuropathic pain.||||0.0139
72431796|NCT00558753|144375576|SUPERIORITY_OR_OTHER||Slope|-4.2||||0.0133||95.0||||Test of condition(Placebo v Pregabalin) main effect.|Mixed Models Analysis|Mixed model with main effects and time by condition interaction.||Mixed model test of condition (Placebo v Pregabalin) main effect.||||0.0133
72431797|NCT00558753|144375576|SUPERIORITY_OR_OTHER||Interaction Slice F-value|1.04||||0.3097||95.0|||||Mixed Models Analysis|Mixed model test of Condition Effect (Placebo v Pregabalin) at the 1-day post surgery time point (Slice)||Test of Condition Effect (Placebo v Pregabalin) at the 1-day post surgery time point (Slice)||||0.3097
72431798|NCT00558753|144375576|SUPERIORITY_OR_OTHER||Interaction Slice F-value|5.1||||0.0247||95.0|||||Mixed Models Analysis|||Test of Condition Effect (Placebo v Pregabalin) at the 2-day post surgery time point (Slice)||||0.0247
72431799|NCT00558753|144375576|SUPERIORITY_OR_OTHER||Interaction Slice F-value|3.11||||0.0786||95.0|||||Mixed Models Analysis|||Test of Condition Effect (Placebo v Pregabalin) at the 3-day post surgery time point (Slice)||||0.0786
72431800|NCT00558753|144375576|SUPERIORITY_OR_OTHER||Interaction Slice F-value|5.04||||0.0254||95.0|||||Mixed Models Analysis|||Test of Condition Effect (Placebo v Pregabalin) at the 30-day post surgery time point (Slice)||||0.0254
72431801|NCT04668144|144375600|NON_INFERIORITY|Under the assumption of 0 difference in mean PRU between groups and a common standard deviation of 50 PRU, a sample size of 22 patients per group would allow for the 95%CI to stay within ± 45 PRU with a 90% power and alpha=0.05. In line with previously reported investigations, 45 PRU was chosen for the noninferiority margin for the upper 95%CI limit of the difference.|Mean Difference (Final Values)|130.0|||||TWO_SIDED|95.0|85.0|176.0||p-value was not calculated for noninferiority analysis|ANCOVA|||The primary hypothesis of our study was that in patients receiving concomitant administration of cangrelor and prasugrel (experimental arm), platelet inhibition as assessed by PRU would be noninferior to patients receiving prasugrel only (active control)||176|85|
72431802|NCT03194776|144375616|SUPERIORITY||Mean Difference (Final Values)|-17.74|||=|0.2612|TWO_SIDED|80.0|-38.03|2.55||P-value of \<= 0.2 was considered significant.|two-sided test|||Statistical analysis was done by mixed effect model repeat measurement (MMRM) model analysis.||2.55|-38.03|= 0.2612
72431803|NCT00929305|144375647|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Fisher Exact|||||||<0.0001
72431804|NCT00929305|144375650|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||||||<0.0001
72553009|NCT01363765|144637165|SUPERIORITY_OR_OTHER||notification rate ratio|1.59|||<|0.01|TWO_SIDED|95.0|1.32|1.87||NR were calculated using an aggregated database consisting of 896 strata for laboratory (n=14), study month (n=8), sex (n=2) and age group (n=4: \<15, 15-39, 40-59, and \>=60 years). Poisson regression modeling was used to analyze changes in TB TB NR|Clustered Avareged|Adjustment for municipality, age, sex, and baseline proportion of samples with a positive smear was by a population-averaged quasi-likelihood approach|"The numbers reported in the CONSORT flowchart refer to the diagnostic samples. NR were obtained crosslinking lab and notification databases, denominator was population/year."|cluster-averaged NNR=1.59 (CI95% 1.31-1.88) Absolute numbers informed in table do not allow calculation of notification rates; they are based on population size, not in total numbers and percentages||1.87|1.32|<0.01
72553010|NCT01363765|144637165|SUPERIORITY_OR_OTHER||notification rate ratio|1.7|||<|0.001|TWO_SIDED|95.0|1.51|1.92|||Mixed Models Analysis|Mixed multi-level model, time-adjusted||Secondary analysis: Mixed multi-level model||1.92|1.51|<0.001
72553011|NCT01363765|144637166|SUPERIORITY_OR_OTHER||incremental cost-effectiveness ratio|-84.07||||||95.0||||||Incremental cost-effectiveness ratio (ICER) per case detected||||||
72553012|NCT01363765|144637167|SUPERIORITY_OR_OTHER||NRR|0.98||||0.923|TWO_SIDED|95.0|0.64|1.32||cluster-averaged adjusted NRR (notification rate ratio, not calculable from number shown, which are a proportion of tests. NRR calculated over a population/year denominator.|Agregated cluster-averaged|||||1.32|0.64|0.923
72553013|NCT01363765|144637168|SUPERIORITY_OR_OTHER||NRR|0.52||||0.004|TWO_SIDED|95.0|0.21|0.84||cluster-averaged adjusted NRR|Agregated cluster-averaged|||||0.84|0.21|0.004
72553014|NCT00635492|144637170|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.16|||<|0.0001|TWO_SIDED|95.0|1.13|1.19|||Regression, Logistic|||Body Mass Index (BMI) - 1kg/m² higher||1.19|1.13|<0.0001
72553015|NCT00635492|144637171|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.77|||<|0.0001|TWO_SIDED|95.0|0.69|0.86|||Regression, Logistic|||Most recent HbA1c at baseline - 1% higher.||0.86|0.69|<0.0001
72553016|NCT00635492|144637172|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.96|||<|0.0001|TWO_SIDED|95.0|0.95|0.97|||Regression, Logistic|||Age - 1 year older||0.97|0.95|<0.0001
72553017|NCT00635492|144637173|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.05||||0.0083|TWO_SIDED|95.0|1.01|1.1|||Regression, Logistic|||Diabetes Health Profile - 18 (DHP-18) subscale disinhibited eating - Yes vs. No||1.10|1.01|0.0083
72553018|NCT00635492|144637174|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.94||||0.0141|TWO_SIDED|95.0|0.9|0.99|||Regression, Logistic|||Random blood glucose - 1 mmol/L higher||0.99|0.90|0.0141
72553019|NCT00635492|144637175|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.98||||0.0107|TWO_SIDED|95.0|0.96|0.99|||Regression, Logistic|||Blood glucose self-monitoring - 1 test/week more||0.99|0.96|0.0107
72553020|NCT00635492|144637176|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.67||||0.0193|TWO_SIDED|95.0|1.13|2.46|||Regression, Logistic|||Receipt of diet/exercise advice - Yes vs. No||2.46|1.13|0.0193
72553021|NCT00635492|144637177|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.83||||0.0138|TWO_SIDED|95.0|0.72|0.96|||Regression, Logistic|||LDL cholesterol - 1 mmol/L higher at baseline||0.96|0.72|0.0138
72553022|NCT00635492|144637185|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.118|||<|0.0001|TWO_SIDED|95.0|1.062|1.177|||Regression, Cox|||HbA1c (%) at baseline||1.177|1.062|<0.0001
72553023|NCT00635492|144637185|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.96||||0.001|TWO_SIDED|95.0|0.937|0.985|||Regression, Cox|||DHP barriers to activity subscale at baseline||0.985|0.937|0.001
72553024|NCT00635492|144637185|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.532|||<|0.001|TWO_SIDED|95.0|1.698|3.777|||Regression, Cox|||Gastrointestinal symptoms: yes vs. no at baseline||3.777|1.698|<0.001
72553025|NCT00635492|144637185|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.437|||<|0.001|TWO_SIDED|95.0|0.303|0.63|||Regression, Cox|||Insulin regimen: basal/bolus vs. long-acting only||0.630|0.303|<0.001
72553026|NCT00635492|144637185|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.676||||0.003|TWO_SIDED|95.0|0.523|0.874|||Regression, Cox|||Insulin regimen: mixtures vs. long-acting only||0.874|0.523|0.003
72553027|NCT00635492|144637185|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.549||||0.303|TWO_SIDED|95.0|0.175|1.718|||Regression, Cox|||Insulin regimen: other vs. long-acting only||1.718|0.175|0.303
72553028|NCT00635492|144637185|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.164|||<|0.001|TWO_SIDED|95.0|1.681|2.785|||Regression, Cox|||Insulin regimen: short-acting only vs. long-acting only||2.785|1.681|<0.001
72553029|NCT00635492|144637186|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.463||||0.028|TWO_SIDED|95.0|1.043|2.053|||Regression, Cox|||GI symptoms: yes vs. no at baseline||2.053|1.043|0.028
72553030|NCT00635492|144637186|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.601||||0.002|TWO_SIDED|95.0|0.432|0.834|||Regression, Cox|||EQ-5D index value at baseline||0.834|0.432|0.002
72553031|NCT01265056|144637205|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
72553032|NCT01265056|144637205|SUPERIORITY||||||<|0.04|||||||Regression, Logistic|||||||<0.04
72553033|NCT01265056|144637206|SUPERIORITY||||||<|0.8|||||||t-test, 2 sided|||||||<0.8
72553034|NCT01265056|144637207|SUPERIORITY|||||||0.8|||||||t-test, 2 sided|||||||0.8
72553035|NCT00440297|144637242|SUPERIORITY_OR_OTHER||Percentage of Seroprotected Participants|48.5||||||95.0|38.4|58.7|||||Exact binomial confidence interval.|No hypothesis is being tested. The purpose of the primary analysis is to estimate the seroprotection rate (percentage of subjects with anti-HBs \>=10mIU/mL) in each group at 1 month after the third dose among subjects who were seronegative at baseline||58.7|38.4|
72553036|NCT00440297|144637242|SUPERIORITY_OR_OTHER||Percentage of Seroprotected Participants|57.7||||||95.0|47.9|67.0|||||Exact binomial confidence interval.|||67.0|47.9|
72553037|NCT00440297|144637243|SUPERIORITY_OR_OTHER||Percentage of Seroprotected Participants|66.7||||||95.0|56.5|75.8|||||Exact binomial confidence interval|||75.8|56.5|
72553038|NCT00440297|144637243|SUPERIORITY_OR_OTHER||Percentage of Seroprotected Participants|69.2||||||95.0|59.4|77.9|||||Exact binomial confidence interval|||77.9|59.4|
72553039|NCT03020641|144637247|OTHER|t-test|Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|0.2347||0.058|TWO_SIDED|95.0||0.1276||the threshold for statistical significance was p\<=0.05.|t-test, 2 sided|||Interleukin 1 (IL1)||0.1276|- 0.8077|0.058
72553040|NCT03020641|144637247|OTHER|Interleukin 6 (IL6)|Mean Difference (Final Values)|-1.02|STANDARD_ERROR_OF_MEAN|0.29||0.001|TWO_SIDED|95.0|-1.6|-0.44|||t-test, 2 sided|||||-0.44|-1.60|0.001
72553041|NCT03020641|144637247|OTHER||Mean Difference (Net)|0.34|STANDARD_ERROR_OF_MEAN|0.211||0.052|TWO_SIDED|95.0|-0.76|0.81|||t-test, 2 sided|||Interleukin 10||0.81|-0.76|0.052
72553042|NCT03020641|144637247|OTHER||Mean Difference (Final Values)|-0.14|STANDARD_ERROR_OF_MEAN|0.181||0.815|TWO_SIDED|95.0|-0.5|0.22|||t-test, 2 sided|||Vascular Endotelial Grow Factor A||0.22|-0.50|0.815
72553043|NCT03020641|144637247|OTHER||Mean Difference (Final Values)|-0.03|STANDARD_ERROR_OF_MEAN|0.19||0.742|TWO_SIDED|95.0|-0.42|0.36|||t-test, 2 sided|||TNF alfa||0.36|-0.42|0.742
72553044|NCT03020641|144637247|OTHER||Mean Difference (Final Values)|0.04|STANDARD_ERROR_OF_MEAN|0.2||0.603|TWO_SIDED|95.0|-0.36|0.44|||t-test, 2 sided|||Chemokine CXC ligand 2||0.44|-0.36|0.603
72553045|NCT03020641|144637248|OTHER||Mean Difference (Final Values)|0.09|STANDARD_ERROR_OF_MEAN|0.28||0.6|TWO_SIDED|95.0|-0.47|0.65|||t-test, 2 sided|||Matrix metalloproteinase-9||0.65|-0.47|0.600
72553046|NCT03020641|144637248|OTHER||Mean Difference (Final Values)|0.5|STANDARD_ERROR_OF_MEAN|0.24||0.028|TWO_SIDED|95.0|0.03|0.97|||t-test, 2 sided|||Plasminogen activator inhibitor-1||0.97|0.030|0.028
72553047|NCT03020641|144637248|OTHER||Mean Difference (Final Values)|0.09|STANDARD_ERROR_OF_MEAN|0.36||0.807|TWO_SIDED|95.0|-0.64|0.82|||t-test, 2 sided|||E-selectin||0.82|-0.64|0.807
72553048|NCT03020641|144637250|OTHER||Mean Difference (Final Values)|-1.37|STANDARD_ERROR_OF_MEAN|4.44||0.862|TWO_SIDED|95.0|-7.49|10.21|||t-test, 2 sided|||||10.21|-7.49|0.862
72553049|NCT02934347|144637275|SUPERIORITY_OR_OTHER||||||>|0.05||||||Grades analysed were 1, 2 and then 3 and 4 combined because of low frequencies in the latter two grades|Chi-squared, Corrected|Chi-squared for trend||Null hypothesis: no difference in frequency of grade of glottic view between the supine and back-up positions||||>0.05
72553050|NCT02934347|144637276|SUPERIORITY_OR_OTHER||||||<|0.01|||||||Chi-squared|df=3||||||<0.01
72553051|NCT02934347|144637277|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Chi-squared|||||||>0.05
72553052|NCT02934347|144637278|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
72553053|NCT04567186|144637314|SUPERIORITY|The superiority of the Test lens was concluded if the upper 95% confidence limit of the mean was below the pre-defined threshold +0.00 logMAR.|Least-square mean|-0.078|STANDARD_ERROR_OF_MEAN|0.0105|||TWO_SIDED|95.0|-0.099|-0.057|||Linear Mixed Model|Kenward and Roger Method was used for denominator degrees of freedom|Distance (4 meter)|It was calculated that 70 participants would have at least 90% power to for the mean visual performance at each distance to be below the hypothesis threshold at the 1-week follow-up. Sample size was determined using one sample means test for equivalence||-0.057|-0.099|
72553054|NCT04567186|144637314|SUPERIORITY|The superiority of the Test lens was concluded if the upper 95% confidence limit of the mean was below the pre-defined threshold + 0.17 logMAR.|Least-square mean|-0.059|STANDARD_ERROR_OF_MEAN|0.01|||TWO_SIDED|95.0|-0.079|-0.039|||Linear Mixed Model|Kenward and Roger Method was used for denominator degrees of freedom|Intermediate (64cm)|It was calculated that 70 participants would have at least 90% power to for the mean visual performance at each distance to be below the hypothesis threshold at the 1-week follow-up. Sample size was determined using one sample means test for equivalence||-0.039|-0.079|
72553055|NCT04567186|144637314|SUPERIORITY|The superiority of the Test lens was concluded if the upper 95% confidence limit of the mean was below the pre-defined threshold +0.17 logMAR.|Least-square Mean|0.062|STANDARD_ERROR_OF_MEAN|0.0111|||TWO_SIDED|95.0|0.04|0.084|||Linear Mixed Model|Kenward and Roger Method was used for the denominator degrees of freedom|Near (40cm)|It was calculated that 70 participants would have at least 90% power to for the mean visual performance at each distance to be below the hypothesis threshold at the 1-week follow-up. Sample size was determined using one sample means test for equivalence||0.084|0.040|
72553056|NCT04567186|144637315|SUPERIORITY|The superiority of the Test lens was concluded if the lower confidence limit of the least-square mean was above the threshold of 32 points.|Least-square Mean|55.93|STANDARD_ERROR_OF_MEAN|2.9027|||TWO_SIDED|95.0|49.25|62.61|||Linear Mixed Model|The Kenward and Roger method was used for the denominator degrees of freedom||This study was powered to only test primary hypotheses.||62.61|49.25|
72553057|NCT04567186|144637315|NON_INFERIORITY|A Non-Inferiority margin of 5 points was used.|Least-square mean difference|-2.98|STANDARD_ERROR_OF_MEAN|1.4708|||TWO_SIDED|95.0|-5.893|-0.073|||Linear Mixed Model|The Kenward and Roger Method was used for the denominator degrees of freedom|mean difference was calculated as Test minus Control|This study was powered for only the primary hypotheses.||-0.073|-5.893|
72553058|NCT00102440|144637323|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority of febuxostat 80 mg to allopurinol was declared if the value of the lower bound of the 97.5% confidence interval is \> -10%.|Difference in percentage|32.0||||||97.5|23.1|41.3||||||||41.3|23.1|
72553059|NCT00102440|144637323|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority of febuxostat 120 mg to allopurinol was declared if the value of the lower bound of the 97.5% confidence interval is \> -10%.|Difference in percentage|41.0||||||97.5|31.5|49.5||||||||49.5|31.5|
72553060|NCT00102440|144637323|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Comparisons of each febuxostat dose to allopurinol were adjusted to control the overall 0.05 level of significance for superiority by using Hochberg's method for multiple comparisons.|Fisher Exact|||||||<0.001
72553061|NCT00102440|144637323|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Comparisons of each febuxostat dose to allopurinol were adjusted to control the overall 0.05 level of significance for superiority by using Hochberg's method for multiple comparisons.|Fisher Exact|||||||<0.001
72553062|NCT00102440|144637323|SUPERIORITY_OR_OTHER|||||||0.072||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Fisher Exact|||||||0.072
72553063|NCT00102440|144637324|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Fisher Exact|||||||<0.001
72553064|NCT00102440|144637324|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Fisher Exact|||||||<0.001
72553065|NCT00102440|144637324|SUPERIORITY_OR_OTHER|||||||0.031||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Fisher Exact|||||||0.031
72553066|NCT00102440|144637325|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Fisher Exact|||||||<0.001
72553067|NCT00102440|144637325|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Fisher Exact|||||||<0.001
72553068|NCT00102440|144637325|SUPERIORITY_OR_OTHER|||||||0.883||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Fisher Exact|||||||0.883
72553069|NCT00102440|144637326|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Fisher Exact|||||||<0.001
72553070|NCT00102440|144637326|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Fisher Exact|||||||<0.001
72553071|NCT00102440|144637326|SUPERIORITY_OR_OTHER|||||||0.164||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Fisher Exact|||||||0.164
72553072|NCT00102440|144637327|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values for pairwise comparisons are from contrast within the framework of the one-way ANOVA model with treatment as a factor. Statistical significance was determined at the 0.05 level without adjustment for multiple comparisons.|ANOVA|||||||<0.001
72553073|NCT00102440|144637327|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values for pairwise comparisons are from contrast within the framework of the one-way ANOVA model with treatment as a factor. Statistical significance was determined at the 0.05 level without adjustment for multiple comparisons.|ANOVA|||||||<0.001
72553074|NCT00102440|144637327|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values for pairwise comparisons are from contrast within the framework of the one-way ANOVA model with treatment as a factor. Statistical significance was determined at the 0.05 level without adjustment for multiple comparisons.|ANOVA|||||||<0.001
72553075|NCT00102440|144637328|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values for pairwise comparisons are from contrast within the framework of the one-way ANOVA model with treatment as a factor. Statistical significance was determined at the 0.05 level without adjustment for multiple comparisons.|ANOVA|||||||<0.001
72553076|NCT00102440|144637328|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values for pairwise comparisons are from contrast within the framework of the one-way ANOVA model with treatment as a factor. Statistical significance was determined at the 0.05 level without adjustment for multiple comparisons.|ANOVA|||||||<0.001
72553077|NCT00102440|144637328|SUPERIORITY_OR_OTHER|||||||0.006||95.0||||P-values for pairwise comparisons are from contrast within the framework of the one-way ANOVA model with treatment as a factor. Statistical significance was determined at the 0.05 level without adjustment for multiple comparisons.|ANOVA|||||||0.006
72553078|NCT00102440|144637329|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values for pairwise comparisons are from contrast within the framework of the one-way ANOVA model with treatment as a factor. Statistical significance was determined at the 0.05 level without adjustment for multiple comparisons.|ANOVA|||||||<0.001
72553079|NCT00102440|144637329|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values for pairwise comparisons are from contrast within the framework of the one-way ANOVA model with treatment as a factor. Statistical significance was determined at the 0.05 level without adjustment for multiple comparisons.|ANOVA|||||||<0.001
72553080|NCT00102440|144637329|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values for pairwise comparisons are from contrast within the framework of the one-way ANOVA model with treatment as a factor. Statistical significance was determined at the 0.05 level without adjustment for multiple comparisons.|ANOVA|||||||<0.001
72553081|NCT00102440|144637330|SUPERIORITY_OR_OTHER||||||>|0.999||95.0||||P-values for pairwise comparisons are from the Wilcoxon rank-sum test. Statistical significance was determined at the 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||>0.999
72553082|NCT00102440|144637330|SUPERIORITY_OR_OTHER|||||||0.011||95.0||||P-values for pairwise comparisons are from the Wilcoxon rank-sum test. Statistical significance was determined at the 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.011
72553083|NCT00102440|144637330|SUPERIORITY_OR_OTHER|||||||0.024||95.0||||P-values for pairwise comparisons are from the Wilcoxon rank-sum test. Statistical significance was determined at the 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.024
72553084|NCT00102440|144637331|SUPERIORITY_OR_OTHER|||||||0.083||95.0||||P-values for pairwise comparisons are from the Wilcoxon rank-sum test. Statistical significance was determined at the 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.083
72553085|NCT00102440|144637331|SUPERIORITY_OR_OTHER|||||||0.164||95.0||||P-values for pairwise comparisons are from the Wilcoxon rank-sum test. Statistical significance was determined at the 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.164
72553086|NCT00102440|144637331|SUPERIORITY_OR_OTHER|||||||0.619||95.0||||P-values for pairwise comparisons are from the Wilcoxon rank-sum test. Statistical significance was determined at the 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.619
72553087|NCT00102440|144637332|SUPERIORITY_OR_OTHER|||||||0.08||95.0||||P-values for pairwise comparisons are from the Wilcoxon rank-sum test. Statistical significance was determined at the 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.080
72553088|NCT00102440|144637332|SUPERIORITY_OR_OTHER|||||||0.372||95.0||||P-values for pairwise comparisons are from the Wilcoxon rank-sum test. Statistical significance was determined at the 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.372
72553089|NCT00102440|144637332|SUPERIORITY_OR_OTHER|||||||0.246||95.0||||P-values for pairwise comparisons are from the Wilcoxon rank-sum test. Statistical significance was determined at the 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.246
72553090|NCT00102440|144637333|SUPERIORITY_OR_OTHER|||||||0.674||95.0||||P-values for pairwise comparisons are from the Wilcoxon rank-sum test. Statistical significance was determined at the 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.674
72553091|NCT00102440|144637333|SUPERIORITY_OR_OTHER|||||||0.32||95.0||||P-values for pairwise comparisons are from the Wilcoxon rank-sum test. Statistical significance was determined at the 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.320
72553092|NCT00102440|144637333|SUPERIORITY_OR_OTHER|||||||0.411||95.0||||P-values for pairwise comparisons are from the Wilcoxon rank-sum test. Statistical significance was determined at the 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.411
72553093|NCT00102440|144637334|SUPERIORITY_OR_OTHER|||||||0.507||95.0||||P-values for pairwise comparisons are from the Wilcoxon rank-sum test. Statistical significance was determined at the 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.507
72553094|NCT00102440|144637334|SUPERIORITY_OR_OTHER|||||||0.188||95.0||||P-values for pairwise comparisons are from the Wilcoxon rank-sum test. Statistical significance was determined at the 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.188
72553095|NCT00102440|144637334|SUPERIORITY_OR_OTHER|||||||0.362||95.0||||P-values for pairwise comparisons are from the Wilcoxon rank-sum test. Statistical significance was determined at the 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.362
72553096|NCT00102440|144637335|SUPERIORITY_OR_OTHER|||||||0.657||95.0||||P-values for pairwise comparisons are from the Wilcoxon rank-sum test. Statistical significance was determined at the 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.657
72553097|NCT00102440|144637335|SUPERIORITY_OR_OTHER|||||||0.444||95.0||||P-values for pairwise comparisons are from the Wilcoxon rank-sum test. Statistical significance was determined at the 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.444
72553098|NCT00102440|144637335|SUPERIORITY_OR_OTHER|||||||0.719||95.0||||P-values for pairwise comparisons are from the Wilcoxon rank-sum test. Statistical significance was determined at the 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.719
72553099|NCT00102440|144637336|SUPERIORITY_OR_OTHER||||||>|0.999||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Fisher Exact|||||||>0.999
72553100|NCT00102440|144637336|SUPERIORITY_OR_OTHER|||||||0.229||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Fisher Exact|||||||0.229
72553101|NCT00102440|144637336|SUPERIORITY_OR_OTHER|||||||0.266||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Fisher Exact|||||||0.266
72553102|NCT01513174|144637396|SUPERIORITY||Hazard Ratio (HR)|1.38||||0.124|TWO_SIDED|95.0|1.0|1.92|||Log Rank||||The initial hypothesis estimated that the median PFS for the gefitinib group would be 10 months, while the median PFS for the gefitinib/olaparib group would be 16 months, which implied a hazard ratio (HR) of 1.6.|1.92|1.00|0.124
72553103|NCT01513174|144637397|SUPERIORITY||Hazard Ratio (HR)|1.22||||0.3455|TWO_SIDED|95.0|0.806|1.845|||Log Rank|||||1.845|0.806|0.3455
72553104|NCT00467363|144637403|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.1||||0.0984|TWO_SIDED|95.0|0.98|1.22||Only one outcome for primary outcome, so no adjustment of p-value for multiple comparisons was done. A priori threshold for statistical significance was p\<0.05.|Fisher Exact|No adjustments were done. Treatment groups were similar with respect to the assessed demographic and baseline characteristics||The study was designed to detect a 10% absolute difference in livebirth rate with 80% power and a type I error rate of 5%, on the assumption that participants taking placebo who achieved pregnancy would have a livebirth rate of 75%.||1.22|0.98|0.0984
72553105|NCT00467363|144637404|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.1||||0.0165|TWO_SIDED|95.0|1.02|1.19|||Fisher Exact|||||1.19|1.02|.0165
72553106|NCT00467363|144637405|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.1||||0.0329|TWO_SIDED|95.0|1.01|1.19|||Fisher Exact|||||1.19|1.01|.0329
72553107|NCT00467363|144637406|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.06||||0.8902|TWO_SIDED|95.0|0.64|1.78|||Fisher Exact|||||1.78|.64|.8902
72553108|NCT00467363|144637407|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.08||||0.6869|TWO_SIDED|95.0|0.76|1.55|||Fisher Exact|||||1.55|.76|.6869
72553109|NCT00467363|144637408|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.68||||0.753|TWO_SIDED|95.0|0.19|2.41|||Fisher Exact|||||2.41|.19|.7530
72553110|NCT00467363|144637409|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.03||||1|TWO_SIDED|95.0|0.15|7.26|||Fisher Exact|||||7.26|.15|1.000
72553111|NCT00467363|144637410|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.03||||1|TWO_SIDED|95.0|0.21|5.06|||Fisher Exact|||||5.06|.21|1.000
72553112|NCT00467363|144637411|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.03||||1|TWO_SIDED|95.0|0.21|5.06|||Fisher Exact|||||5.06|.21|1.000
72553113|NCT00467363|144637412|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.08||||0.7943|TWO_SIDED|95.0|0.67|1.76|||Fisher Exact|||||1.76|.67|.7943
72553114|NCT00467363|144637413|SUPERIORITY_OR_OTHER|||||||0.7802|||||||t-test, 2 sided|||||||.7802
72553115|NCT00467363|144637414|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.72||||0.2603|TWO_SIDED|95.0|0.42|1.23|||Fisher Exact|||||1.23|.42|.2603
72553116|NCT00467363|144637417|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.3||||0.77|TWO_SIDED|95.0|-0.8|1.4|||Fisher Exact|||||1.4|-0.8|0.77
72553117|NCT02169115|144637421|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.8|STANDARD_DEVIATION|1.7||0.05|TWO_SIDED||||||ANOVA|||||||0.05
72553118|NCT02169115|144637421|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.0|STANDARD_DEVIATION|1.8||0.005|TWO_SIDED||||||ANOVA|||||||0.005
72553119|NCT02169115|144637421|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.6|STANDARD_DEVIATION|1.4|||TWO_SIDED|||||||||||||
72553120|NCT00836056|144637452|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, ANOVA (Analysis of Variance) will be performed on log-transformed AUC0-t, AUC0-inf and Cmax at the alpha level of 0.05.|Test/Ref Ratio of LS Means x 100|97.75||||||90.0|91.5|104.42|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||104.42|91.50|
72553121|NCT00836056|144637453|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, ANOVA (Analysis of Variance) will be performed on log-transformed AUC0-t, AUC0-inf and Cmax at the alpha level of 0.05.|Test/Ref Ratio of LS Means x 100|96.77||||||90.0|91.4|102.46|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||102.46|91.40|
72553122|NCT00836056|144637454|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, ANOVA (Analysis of Variance) will be performed on log-transformed AUC0-t, AUC0-inf and Cmax at the alpha level of 0.05.|Test/Ref Ratio of LS Means x 100|95.96||||||90.0|90.77|101.46|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||101.46|90.77|
72553123|NCT02648347|144637475|NON_INFERIORITY|Establishment of non-inferiority was based on a margin of -0.75 g/dL applied to the difference in mean change: Vadadustat minus Darbepoetin alfa.|Least squares mean difference|0.05|STANDARD_ERROR_OF_MEAN|0.048|||TWO_SIDED|95.0|-0.04|0.15||||||Treatment comparison: Vadadustat minus Darbepoetin Alfa||0.15|-0.04|
72553124|NCT02648347|144637476|NON_INFERIORITY|The prespecified non-inferiority margin was 1.25 (per Food and Drug Administration \[FDA\]) and 1.3 (per European Medicines Agency \[EMA\]).|Hazard Ratio (HR)|1.16|||=|0.205|TWO_SIDED|95.0|0.955|1.412|||Log Rank|||Statistical analysis from study AKB-6548-CI-0014 has been reported in this section.||1.412|0.955|=0.2050
72553125|NCT02648347|144637476|NON_INFERIORITY|The prespecified non-inferiority margin was 1.25 (per FDA) and 1.3 (per EMA).|Hazard Ratio (HR)|1.17|||=|0.0725|TWO_SIDED|95.0|1.012|1.355|||Log Rank|Based on non-parametric analysis.||MACE analysis was performed on pooled data from studies AKB-6548-CI-0014 (NCT02648347) and AKB-6548-CI-0015 (NCT02680574). Time to first MACE for the Vadadustat and Darbepoetin alfa treatment groups was as follows: participants with events = 382 and 344 respectively; median time to first event (Q1, Q3) = 50.07 (23.00, 82.86) weeks versus 51.93 (27.79, 91.00) weeks, respectively. Statistical analysis from the pooled data has been reported in this section.||1.355|1.012|=0.0725
72553126|NCT02648347|144637477|NON_INFERIORITY|Establishment of non-inferiority was based on a margin of -0.75 g/dL applied to the difference in mean change: Vadadustat minus Darbepoetin alfa.|Least squares mean difference|0.04|STANDARD_ERROR_OF_MEAN|0.052|||TWO_SIDED|95.0|-0.06|0.14||||||Treatment comparison: Vadadustat minus Darbepoetin Alfa||0.14|-0.06|
72553127|NCT02648347|144637478|NON_INFERIORITY|The prespecified non-inferiority margin was 1.25 (per FDA) and 1.3 (per EMA).|Hazard Ratio (HR)|1.16|||=|0.1743|TWO_SIDED|95.0|0.966|1.382|||Log Rank|Based on non-parametric analysis.||Statistical analysis from study AKB-6548-CI-0014 has been reported in this section.||1.382|0.966|=0.1743
72553128|NCT02648347|144637478|NON_INFERIORITY|The prespecified non-inferiority margin was 1.25 (per FDA) and 1.3 (per EMA).|Hazard Ratio (HR)|1.11|||=|0.2305|TWO_SIDED|95.0|0.972|1.267|||Log Rank|Based on non-parametric analysis.||MACE analysis was performed on pooled data from studies AKB-6548-CI-0014 (NCT02648347) and AKB-6548-CI-0015 (NCT02680574). Time to first MACE plus hospitalization for heart failure or thromboembolic events excluding vascular access thrombosis for the Vadadustat and Darbepoetin alfa treatment groups was as follows: participants with events = 451 and 424 respectively; median time to first event (Q1, Q3) = 42.86 (19.71, 73.43) weeks versus 43.86 (21.36, 80.43) weeks, respectively.||1.267|0.972|=0.2305
72553129|NCT02648347|144637479|NON_INFERIORITY|The prespecified non-inferiority margin was 1.25 (per FDA) and 1.3 (per EMA).|Hazard Ratio (HR)|1.19|||=|0.3154|TWO_SIDED|95.0|0.901|1.564|||Gray's Test|Based on non-parametric analysis.||Statistical analysis from study AKB-6548-CI-0014 has been reported in this section.||1.564|0.901|=0.3154
72553130|NCT02648347|144637479|NON_INFERIORITY|The prespecified non-inferiority margin was 1.25 (per FDA) and 1.3 (per EMA).|Hazard Ratio (HR)|1.16|||=|0.2531|TWO_SIDED|95.0|0.947|1.42|||Gray's Test|Based on non-parametric analysis.||MACE analysis was performed on pooled data from studies AKB-6548-CI-0014 (NCT02648347) and AKB-6548-CI-0015 (NCT02680574). Time to first cardiovascular MACE for the Vadadustat and Darbepoetin alfa treatment groups was as follows: participants with events = 198 and 178 respectively; median time to first event (Q1, Q3) = 45.57 (21.71, 73.29) weeks versus 47.36 (20.00, 88.43) weeks, respectively. Statistical analysis from the pooled data has been reported in this section.||1.420|0.947|=0.2531
72553131|NCT02648347|144637480|NON_INFERIORITY|The prespecified non-inferiority margin was 1.25 (per FDA) and 1.3 (per EMA).|Hazard Ratio (HR)|1.13|||=|0.5991|TWO_SIDED|95.0|0.808|1.594|||Gray's test|Based on non-parametric analysis.||Statistical analysis from study AKB-6548-CI-0014 has been reported in this section.||1.594|0.808|=0.5991
72553132|NCT02648347|144637480|NON_INFERIORITY|The prespecified non-inferiority margin was 1.25 (per FDA) and 1.3 (per EMA).|Hazard Ratio (HR)|1.01|||=|0.8613|TWO_SIDED|95.0|0.792|1.293|||Gray's test|Based on non-parametric analysis.||MACE analysis was performed on pooled data from studies AKB-6548-CI-0014 (NCT02648347) and AKB-6548-CI-0015 (NCT02680574). Time to first cardiovascular death for the Vadadustat and Darbepoetin alfa treatment groups was as follows: participants with events = 127 and 131 respectively; median time to first event (Q1, Q3) = 48.29 (28.86, 76.14) weeks versus 48.43 (21.29, 92.29) weeks, respectively. Statistical analysis from the pooled data has been reported in this section.||1.293|0.792|=0.8613
72553133|NCT02648347|144637481|NON_INFERIORITY|The prespecified non-inferiority margin was 1.25 (per FDA) and 1.3 (per EMA).|Hazard Ratio (HR)|1.11|||=|0.4388|TWO_SIDED|95.0|0.902|1.375|||Log Rank|Based on non-parametric analysis.||Statistical analysis from study AKB-6548-CI-0014 has been reported in this section.||1.375|0.902|=0.4388
72553134|NCT02648347|144637481|NON_INFERIORITY|The prespecified non-inferiority margin was 1.25 (per FDA) and 1.3 (per EMA).|Hazard Ratio (HR)|1.09|||=|0.4577|TWO_SIDED|95.0|0.93|1.274|||Log Rank|Based on non-parametric analysis.||MACE analysis was performed on pooled data from studies AKB-6548-CI-0014 (NCT02648347) and AKB-6548-CI-0015 (NCT02680574). Time to first all-cause mortality for the Vadadustat and Darbepoetin alfa treatment groups was as follows: participants with events = 319 and 307 respectively; median time to first event (Q1, Q3) = 52.14 (28.71, 84.71) weeks versus 53.00 (30.71, 94.14) weeks, respectively. Statistical analysis from the pooled data has been reported in this section.||1.274|0.930|=0.4577
72553135|NCT01639222|144637492|SUPERIORITY_OR_OTHER||Calcium-Vitamin D/Reference (%)|179.72|||||TWO_SIDED|95.0|157.16|205.52|||||Point estimates and 95% CIs for the treatment difference ratio (Calcium-Vitamin D/reference treatment) are provided on the original scale as a ratio \* 100%.|The primary parameters were analysed in a mixed effects general linear model of the logtransformed values, including treatment as a fixed effect and subject as a random effect. The objective of the trial was met if the treatment contrast was statistically significantly different from 0 in the appropriate direction in a 2-sided test on a 5% significance level for both parameters. The 5% significance level for both primary parameters was not adjusted for multiple testing.||205.52|157.16|
72553136|NCT01639222|144637493|SUPERIORITY_OR_OTHER||Calcium-Vitamin D/Reference (%)|71.77|||||TWO_SIDED|95.0|68.83|74.84|||||Point estimate and 95% CI for the treatment difference ratio (Calcium-Vitamin D /reference treatment) are provided on the original scale as a ratio \* 100%.|||74.84|68.83|
72553137|NCT01639222|144637494|SUPERIORITY_OR_OTHER||Calcium-Vitamin D/Reference (%)|156.74|||||TWO_SIDED|95.0|121.66|201.93|||||Point estimates and 95% CIs for the treatment difference ratio (Calcium-Vitamin D / reference treatment) are provided on the original scale as a ratio \* 100%.|||201.93|121.66|
72553138|NCT01416584|144637528|SUPERIORITY||Odds Ratio (OR)|1.4||||0.6|TWO_SIDED|95.0|0.4|4.83|||General Estimating Equation (GEE)|||||4.83|0.40|0.60
72553139|NCT01416584|144637528|SUPERIORITY||Odds Ratio (OR)|1.1||||0.88|TWO_SIDED|95.0|0.32|3.73|||General Estimating Equation (GEE)|||||3.73|0.32|0.88
72553140|NCT01416584|144637528|SUPERIORITY||Odds Ratio (OR)|1.27||||0.64|TWO_SIDED|95.0|0.36|4.46|||General Estimating Equation (GEE)|||||4.46|0.36|0.64
72553141|NCT01416584|144637529|SUPERIORITY||Odds Ratio (OR)|0.39||||0.02|TWO_SIDED|95.0|0.38|0.41|||General Estimating Equation (GEE)|||||0.41|0.38|0.02
72553142|NCT01416584|144637529|SUPERIORITY||Odds Ratio (OR)|0.73||||0.39|TWO_SIDED|95.0|0.34|1.57|||General Estimating Equation (GEE)|||||1.57|0.34|0.39
72553143|NCT01416584|144637529|SUPERIORITY||Odds Ratio (OR)|1.86||||0.1|TWO_SIDED|95.0|1.53|2.26|||General Estimating Equation (GEE)|||||2.26|1.53|0.10
72553144|NCT01416584|144637530|SUPERIORITY||Odds Ratio (OR)|0.37||||0.02|TWO_SIDED|95.0|0.36|0.38|||General Estimating Equation (GEE)|||||0.38|0.36|0.02
72553145|NCT01416584|144637530|SUPERIORITY||Odds Ratio (OR)|0.39||||0.02|TWO_SIDED|95.0|0.38|0.41|||General Estimating Equation (GEE)|||||0.41|0.38|0.02
72553146|NCT01416584|144637530|SUPERIORITY||Odds Ratio (OR)|1.07||||0.85|TWO_SIDED|95.0|0.2|5.66|||General Estimating Equation (GEE)|||||5.66|0.20|0.85
72553147|NCT01416584|144637531|SUPERIORITY||Odds Ratio (OR)|0.35||||0.01|TWO_SIDED|95.0|0.34|0.35|||General Estimating Equation (GEE)|||||0.35|0.34|0.01
72553148|NCT01416584|144637531|SUPERIORITY||Odds Ratio (OR)|0.41||||0.03|TWO_SIDED|95.0|0.39|0.44|||General Estimating Equation (GEE)|||||0.44|0.39|0.03
72553149|NCT01416584|144637531|SUPERIORITY||Odds Ratio (OR)|0.84||||0.63|TWO_SIDED|95.0|0.42|1.69|||General Estimating Equation (GEE)|||||1.69|0.42|0.63
72553150|NCT01416584|144637532|SUPERIORITY||Odds Ratio (OR)|0.4||||0.01|TWO_SIDED|95.0|0.39|0.4|||General Estimating Equation (GEE)|||||0.40|0.39|0.01
72553151|NCT01416584|144637532|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.75||||0.37|TWO_SIDED|95.0|0.36|1.55|||General Estimating Equation (GEE)|||||1.55|0.36|0.37
72553152|NCT01416584|144637532|SUPERIORITY||Odds Ratio (OR)|0.53||||0.05|TWO_SIDED|95.0|0.28|1.0|||General Estimating Equation (GEE)|||||1.00|0.28|0.05
72553153|NCT03117296|144637545|OTHER||Rank-Sum|0.05|||<|0.01|TWO_SIDED||||||Fisher Exact|||Univariate 2-group comparisons were performed using χ2 and Fisher's exact tests (when expected cell counts are \<5) for categorical variables, using 2-group t tests and Wilcoxon rank-sum tests (when normality distributions were violated) for continuous variables. Statistical significance was set at P \< .05. All analyses were performed using SAS 9.4 (SAS Institute, Cary, North Carolina).||||<0.01
72553154|NCT00833937|144637570|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Ratio of Geometric Means|99.7||||||90.0|93.9|106.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||106|93.9|
72553155|NCT00833937|144637571|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Ratio of Geometric Means|97.8||||||90.0|92.6|103.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||103|92.6|
72553156|NCT00833937|144637572|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Ratio of Geometric Means|97.9||||||90.0|92.7|103.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||103|92.7|
72553157|NCT01304641|144637590|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Chi-squared|||||||<0.001
72553158|NCT01304641|144637591|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.078||||0.14|TWO_SIDED|95.0|0.976|1.192|||Regression, Cox|||||1.192|0.976|0.140
72553159|NCT01304641|144637592|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||t-test, 2 sided|||||||<0.001
72553160|NCT01304641|144637593|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||t-test, 2 sided|||||||<0.001
72553161|NCT01304641|144637594|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Chi-squared|||||||<0.001
72553162|NCT01304641|144637595|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||t-test, 2 sided|||||||<0.001
72553163|NCT01304641|144637596|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Chi-squared|||||||<0.001
72553164|NCT04544787|144637597|OTHER|||||||0.7209|||||||Fisher Exact|||The number of participants with severe solicited adverse events in the OPV-vaccinated groups who received nOPV-c1 (combined Groups 1 and 2) was compared with the corresponding endpoint from the historical monovalent OPV2 control study (UAM1, EudraCT # 2015-003325-33) using the two-sided Fisher's exact test. In the UAM1 study, the number of participants with severe solicited adverse events was 5 out of 100.||||0.7209
72553165|NCT04544787|144637597|OTHER|||||||0.7209|||||||Fisher Exact|||The number of participants with severe solicited adverse events in the OPV-vaccinated groups who received nOPV-c2 (combined Groups 3 and 4) was compared with the corresponding endpoint from the historical monovalent OPV2 control study (UAM1, EudraCT # 2015-003325-33) using the two-sided Fisher's exact test. In the UAM1 study, the number of participants with severe solicited adverse events was 5 out of 100.||||0.7209
72553166|NCT04544787|144637597|OTHER|||||||0.3769|||||||Fisher Exact|||The number of participants with severe unsolicited adverse events in the OPV-vaccinated groups who received nOPV-c1 (combined Groups 1 and 2) was compared with the corresponding endpoint from the historical monovalent OPV2 control study (UAM1, EudraCT # 2015-003325-33) using the two-sided Fisher's exact test. In the UAM1 study, the number of participants with severe unsolicited adverse events was 17 out of 100.||||0.3769
72553167|NCT04544787|144637597|OTHER|||||||0.3083|||||||Fisher Exact|||The number of participants with severe unsolicited adverse events in the OPV-vaccinated groups who received nOPV-c2 (combined Groups 3 and 4) was compared with the corresponding endpoint from the historical monovalent OPV2 control study (UAM1, EudraCT # 2015-003325-33) using the two-sided Fisher's exact test. In the UAM1 study, the number of participants with severe unsolicited adverse events was 17 out of 100.||||0.3083
72553168|NCT04544787|144637597|OTHER|||||||0.4975|||||||Fisher Exact|||The number of participants with serious unsolicited adverse events in the OPV-vaccinated groups who received nOPV-c1 (combined Groups 1 and 2) was compared with the corresponding endpoint from the historical monovalent OPV2 control study (UAM1, EudraCT # 2015-003325-33) using the two-sided Fisher's exact test. In the UAM1 study, the number of participants with serious unsolicited adverse events was 0 out of 100.||||0.4975
72553169|NCT04544787|144637597|OTHER|||||||1|||||||Fisher Exact|||The number of participants with serious unsolicited adverse events in the OPV-vaccinated groups who received nOPV-c2 (combined Groups 3 and 4) was compared with the corresponding endpoint from the historical monovalent OPV2 control study (UAM1, EudraCT # 2015-003325-33) using the two-sided Fisher's exact test. In the UAM1 study, the number of participants with serious unsolicited adverse events was 0 out of 100.||||1.0000
72553170|NCT04544787|144637597|OTHER|||||||1|||||||Fisher Exact|||Comparison of severe solicited adverse events||||1.0000
72553171|NCT04544787|144637597|OTHER|||||||1|||||||Fisher Exact|||Comparison of severe solicited adverse events||||1.0000
72553172|NCT04544787|144637597|OTHER|||||||0.1571|||||||Fisher Exact|||Comparison of severe unsolicited adverse events||||0.1571
72553173|NCT04544787|144637597|OTHER|||||||0.296|||||||Fisher Exact|||Comparison of severe unsolicited adverse events||||0.2960
72367103|NCT04032093|144244982|OTHER||Geometric Mean Ratio|15.8|||||TWO_SIDED|95.0|10.7|23.4|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|A 50%: 2 Months after birth||23.4|10.7|
72367104|NCT04032093|144244982|OTHER||Geometric Mean Ratio|5.6|||||TWO_SIDED|95.0|3.5|9.0|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|A 50%: 4 Months after birth||9.0|3.5|
72367105|NCT04032093|144244982|OTHER||Geometric Mean Ratio|6.6|||||TWO_SIDED|95.0|4.5|9.6|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|A 50%: 6 Months after birth||9.6|4.5|
72367106|NCT04032093|144244982|OTHER||Geometric Mean Ratio|14.9|||||TWO_SIDED|95.0|11.1|19.9|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|B 50%: At birth||19.9|11.1|
72367107|NCT04032093|144244982|OTHER||Geometric Mean Ratio|11.0|||||TWO_SIDED|95.0|6.5|18.6|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|B 50%: 1 Month after birth||18.6|6.5|
72367108|NCT04032093|144244982|OTHER||Geometric Mean Ratio|19.2|||||TWO_SIDED|95.0|13.1|28.0|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|B 50%: 2 Months after birth||28.0|13.1|
72367109|NCT04032093|144244982|OTHER||Geometric Mean Ratio|6.9|||||TWO_SIDED|95.0|4.2|11.4|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|B 50%: 4 Months after birth||11.4|4.2|
72367110|NCT04032093|144244982|OTHER||Geometric Mean Ratio|7.3|||||TWO_SIDED|95.0|4.5|11.8|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|B 50%: 6 Months after birth||11.8|4.5|
72367111|NCT04032093|144244982|OTHER||Geometric Mean Ratio|10.8|||||TWO_SIDED|95.0|8.3|14.2|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|A 50%: At birth||14.2|8.3|
72367112|NCT04032093|144244982|OTHER||Geometric Mean Ratio|9.7|||||TWO_SIDED|95.0|6.5|14.5|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|A 50%: 1 Month after birth||14.5|6.5|
72367113|NCT04032093|144244982|OTHER||Geometric Mean Ratio|10.6|||||TWO_SIDED|95.0|7.1|15.9|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|A 50%: 2 Months after birth||15.9|7.1|
72367114|NCT04032093|144244982|OTHER||Geometric Mean Ratio|8.2|||||TWO_SIDED|95.0|5.2|12.9|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|A 50%: 4 Months after birth||12.9|5.2|
72367115|NCT04032093|144244982|OTHER||Geometric Mean Ratio|4.8|||||TWO_SIDED|95.0|3.1|7.5|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|A 50%: 6 Months after birth||7.5|3.1|
72367116|NCT04032093|144244982|OTHER||Geometric Mean Ratio|14.0|||||TWO_SIDED|95.0|10.5|18.7|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|B 50%: At birth||18.7|10.5|
72367117|NCT04032093|144244982|OTHER||Geometric Mean Ratio|11.8|||||TWO_SIDED|95.0|7.4|18.7|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|B 50%: 1 Month after birth||18.7|7.4|
72367118|NCT04032093|144244982|OTHER||Geometric Mean Ratio|11.9|||||TWO_SIDED|95.0|7.7|18.3|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|B 50%: 2 Months after birth||18.3|7.7|
72367119|NCT04032093|144244982|OTHER||Geometric Mean Ratio|8.9|||||TWO_SIDED|95.0|5.5|14.5|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|B 50%: 4 Months after birth||14.5|5.5|
72367120|NCT04032093|144244982|OTHER||Geometric Mean Ratio|5.4|||||TWO_SIDED|95.0|3.3|8.8|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|B 50%: 6 Months after birth||8.8|3.3|
72367121|NCT04032093|144244982|OTHER||Geometric Mean Ratio|9.5|||||TWO_SIDED|95.0|7.4|12.3|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|A 50%: At birth||12.3|7.4|
72367122|NCT04032093|144244982|OTHER||Geometric Mean Ratio|8.4|||||TWO_SIDED|95.0|5.7|12.4|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|A 50%: 1 Month after birth||12.4|5.7|
72367123|NCT04032093|144244982|OTHER||Geometric Mean Ratio|9.9|||||TWO_SIDED|95.0|6.4|15.4|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|A 50%: 2 Months after birth||15.4|6.4|
72367124|NCT04032093|144244982|OTHER||Geometric Mean Ratio|4.5|||||TWO_SIDED|95.0|2.9|6.8|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|A 50%: 4 Months after birth||6.8|2.9|
72367125|NCT04032093|144244982|OTHER||Geometric Mean Ratio|4.0|||||TWO_SIDED|95.0|2.5|6.3|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|A 50%: 6 Months after birth||6.3|2.5|
72367126|NCT04032093|144244982|OTHER||Geometric Mean Ratio|12.4|||||TWO_SIDED|95.0|9.2|16.6|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|B 50%: At birth||16.6|9.2|
72367127|NCT04032093|144244982|OTHER||Geometric Mean Ratio|11.3|||||TWO_SIDED|95.0|7.1|17.9|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|B 50%: 1 Month after birth||17.9|7.1|
72367128|NCT04032093|144244982|OTHER||Geometric Mean Ratio|10.4|||||TWO_SIDED|95.0|7.0|15.2|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|B 50%: 2 Months after birth||15.2|7.0|
72367129|NCT04032093|144244982|OTHER||Geometric Mean Ratio|5.7|||||TWO_SIDED|95.0|3.7|9.0|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|B 50%: 4 Months after birth||9.0|3.7|
72367130|NCT04032093|144244982|OTHER||Geometric Mean Ratio|4.3|||||TWO_SIDED|95.0|2.7|7.0|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|B 50%: 6 Months after birth||7.0|2.7|
72367131|NCT04032093|144244982|OTHER||Geometric Mean Ratio|11.3|||||TWO_SIDED|95.0|8.6|14.9|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|A 50%: At birth||14.9|8.6|
72367132|NCT04032093|144244982|OTHER||Geometric Mean Ratio|10.2|||||TWO_SIDED|95.0|7.4|14.0|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|A 50%: 1 Month after birth||14.0|7.4|
72367133|NCT04032093|144244982|OTHER||Geometric Mean Ratio|15.0|||||TWO_SIDED|95.0|10.2|22.1|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|A 50%: 2 Months after birth||22.1|10.2|
72367134|NCT04032093|144244982|OTHER||Geometric Mean Ratio|6.1|||||TWO_SIDED|95.0|3.9|9.6|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|A 50%: 4 Months after birth||9.6|3.9|
72367135|NCT04032093|144244982|OTHER||Geometric Mean Ratio|4.5|||||TWO_SIDED|95.0|2.9|6.9|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|A 50%: 6 Months after birth||6.9|2.9|
72367136|NCT04032093|144244982|OTHER||Geometric Mean Ratio|16.2|||||TWO_SIDED|95.0|12.5|21.2|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|B 50%: At birth||21.2|12.5|
72367137|NCT04032093|144244982|OTHER||Geometric Mean Ratio|12.8|||||TWO_SIDED|95.0|8.6|19.1|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|B 50%: 1 Month after birth||19.1|8.6|
72367138|NCT04032093|144244982|OTHER||Geometric Mean Ratio|17.7|||||TWO_SIDED|95.0|11.9|26.2|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|B 50%: 2 Months after birth||26.2|11.9|
72367139|NCT04032093|144244982|OTHER||Geometric Mean Ratio|9.0|||||TWO_SIDED|95.0|5.7|14.4|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|B 50%: 4 Months after birth||14.4|5.7|
72367140|NCT04032093|144244982|OTHER||Geometric Mean Ratio|6.2|||||TWO_SIDED|95.0|3.9|9.9|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|B 50%: 6 Months after birth||9.9|3.9|
72367141|NCT02952820|144245012|SUPERIORITY||least squares geometric mean (LSGM)ratio|0.732|||<|0.0001|TWO_SIDED|95.0|0.636|0.843|||Mixed Models Analysis|||Analysis was based on mixed effect model repeated measurement analysis (MMRM) model with log transformation of sSOL and factors for age group, region, treatment, visit (Month 6), and treatment-by-visit interaction as fixed effects, and the study baseline sSOL as a covariate. Missing values are imputed using multiple imputation and assumed to be missing not at random (missing not at random/complete case missing value \[MNAR/CCMV\]).||0.843|0.636|<.0001
72367142|NCT02952820|144245012|SUPERIORITY||LSGM ratio|0.701|||<|0.0001|TWO_SIDED|95.0|0.607|0.81|||Mixed Models Analysis|||Analysis was based on MMRM model with log transformation of sSOL and factors for age group, region, treatment, visit (Month 6), and treatment-by-visit interaction as fixed effects, and the study baseline sSOL as a covariate. Missing values are imputed using multiple imputation and assumed to be missing not at random (MNAR/CCMV).||0.810|0.607|<.0001
72367143|NCT02952820|144245013|SUPERIORITY||LSGM ratio|0.781|||<|0.0001|TWO_SIDED|95.0|0.725|0.842|||Mixed Models Analysis|||First 7 nights after the first dose (Statistical analysis 1): Based on MMRM model with log transformation of sSOL and factors for age group, region, treatment, visit (First 7 nights), and treatment-by-visit interaction as fixed effects, and the study baseline sSOL as a covariate. Missing values are imputed using multiple imputation and assumed to be missing not at random (MNAR/CCMV).||0.842|0.725|<.0001
72367144|NCT02952820|144245013|SUPERIORITY||LSGM ratio|0.752|||<|0.0001|TWO_SIDED|95.0|0.698|0.811|||Mixed Models Analysis|||First 7 nights after the first dose (Statistical analysis 2): Based on MMRM model with log transformation of sSOL and factors for age group, region, treatment, visit (First 7 nights), and treatment-by-visit interaction as fixed effects, and the study baseline sSOL as a covariate. Missing values are imputed using multiple imputation and assumed to be missing not at random (MNAR/CCMV).||0.811|0.698|<.0001
72553174|NCT04544787|144637598|NON_INFERIORITY|The primary immunogenicity endpoint, seroprotection on Day 28 after a single dose of each vaccine candidate, was formally compared with the corresponding endpoint from UAM1 via a non-inferiority test of the difference of each of the novel candidates to the monovalent OPV2 control, mOPV2, each using one-sided α=0.025 and a non-inferiority margin of 10%, computed using two-sided α=0·05 Miettinen and Nurminen score-based CIs for inference.|Difference|2.0|||||TWO_SIDED|95.0|-1.9|7.0||||||The primary immunogenicity endpoint, the seroprotection rate after one dose of either vaccine candidate in the OPV-vaccinated groups (nOPV2 combined groups 1 and 2, and combined groups 3 and 4), was compared with the corresponding endpoint from the historical monovalent OPV2 (mOPV2) control study (UAM1, EudraCT # 2015-003325-33). In the UAM1 study, the observed seroprotection rate after a single dose of mOPV2 was 98% (98 out of 100 participants), with a 95% confidence interval (CI) of 93-100%.||7.0|-1.9|
72553175|NCT04544787|144637598|NON_INFERIORITY|The primary immunogenicity endpoint, seroprotection on Day 28 after a single dose of each vaccine candidate, was formally compared with the corresponding endpoint from UAM1 via a non-inferiority test of the difference of each of the novel candidates to the monovalent OPV2 control, mOPV2, each using one-sided α=0.025 and a non-inferiority margin of 10%, computed using two-sided α=0·05 Miettinen and Nurminen score-based CIs for inference.|Difference|2.0|||||TWO_SIDED|95.0|-1.8|7.0||||||The primary immunogenicity endpoint, the seroprotection rate after one dose of either vaccine candidate in the OPV-vaccinated groups (nOPV2 combined groups 1 and 2, and combined groups 3 and 4), was compared with the corresponding endpoint from the historical monovalent OPV2 control study (UAM1, EudraCT # 2015-003325-33). In the UAM1 study, the observed seroprotection rate after a single dose of mOPV2 was 98% (98 out of 100 participants), with a 95% confidence interval (CI) of 93-100%.||7.0|-1.8|
72553176|NCT00465270|144637610|OTHER||Cox Proportional Hazard|0.49||||0.08|TWO_SIDED|95.0|0.22|1.11|||Log Rank|||||1.11|0.22|0.08
72553177|NCT00465270|144637612|OTHER||Cox Proportional Hazard|0.55||||0.046|TWO_SIDED|95.0|0.31|0.999|||Log Rank|||||0.999|0.31|0.046
72553178|NCT03686033|144637747|SUPERIORITY||LS Mean difference|1.12|||||TWO_SIDED|90.0|-0.98|3.22||||||The mixed effects model for the crossover part of the study will include treatment, period, and sequence as fixed effects, baseline (predose) measurement as a covariate, and subject nested within sequence as a random effect. Least Square (LS) Mean Difference was calculated for 2.5 mg versus (vs) Placebo only.||3.22|-0.98|
72553179|NCT03686033|144637747|SUPERIORITY||LS Mean difference|-4.17|||||TWO_SIDED|90.0|-6.35|-1.99||||||The mixed effects model for the crossover part of the study will include treatment, period, and sequence as fixed effects, baseline (predose) measurement as a covariate, and subject nested within sequence as a random effect. LS Mean Difference was calculated for 25 mg vs Placebo only.||-1.99|-6.35|
72553180|NCT01045161|144637760|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.051||||0.019|TWO_SIDED|95.0|0.01|0.09|||ANCOVA|||||0.09|0.01|0.019
72553181|NCT01045161|144637760|SUPERIORITY_OR_OTHER||Least squares mean difference|0.072||||0.0012|TWO_SIDED|95.0|0.03|0.12|||ANCOVA|||||0.12|0.03|0.0012
72553182|NCT01045161|144637762|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.051||||0.0192|TWO_SIDED|95.0|0.01|0.09|||ANCOVA|||||0.09|0.01|0.0192
72553183|NCT01045161|144637762|SUPERIORITY_OR_OTHER||Least Squares Mean difference|0.072||||0.0012|TWO_SIDED|95.0|0.03|0.12|||ANCOVA|||||0.12|0.03|0.0012
72553184|NCT02612337|144637817|SUPERIORITY|The target sample size for each was 160 randomized subjects: 80 in each treatment group stratified by gender. The sample size estimate was chosen to achieve more than 90% power with a significance level of 0.05 2-sided to reject the null hypothesis of no treatment difference for the primary endpoint of DVD.|Risk Ratio (RR)|0.907||||0.623|TWO_SIDED|95.0|0.615|1.339|||Regression, Linear|||The primary efficacy endpoint was compared between OTO-104 and placebo at the 2-tailed 0.05 alpha level using a generalized Poisson linear mixed model. The model included fixed effects for randomized treatment group, sex, study week, a treatment group by study week interaction, and the count of lead-in period DVD standardized to 28 days as a covariate.||1.339|0.615|0.623
72553185|NCT02242201|144637823|SUPERIORITY|||||||0.033|||||||Wilcoxon (Mann-Whitney)|||||||0.033
72553186|NCT02242201|144637823|SUPERIORITY|||||||0.662|||||||Wilcoxon (Mann-Whitney)|||||||0.662
72553187|NCT02242201|144637823|SUPERIORITY|||||||0.103|||||||Wilcoxon (Mann-Whitney)|||||||0.103
72553188|NCT02242201|144637824|SUPERIORITY|||||||0.948|||||||Wilcoxon (Mann-Whitney)|||Preoperative||||0.948
72553189|NCT02242201|144637824|SUPERIORITY|||||||0.88|||||||Wilcoxon (Mann-Whitney)|||Preoperative||||0.880
72553190|NCT02242201|144637824|SUPERIORITY|||||||0.802|||||||Wilcoxon (Mann-Whitney)|||Preoperative||||0.802
72553191|NCT02242201|144637824|SUPERIORITY|||||||0.179|||||||Wilcoxon (Mann-Whitney)|||Intraoperative||||0.179
72553192|NCT02242201|144637824|SUPERIORITY|||||||0.837|||||||Wilcoxon (Mann-Whitney)|||Intraoperative||||0.837
72553193|NCT02242201|144637824|SUPERIORITY|||||||0.142|||||||Wilcoxon (Mann-Whitney)|||Intraoperative||||0.142
72553194|NCT02242201|144637824|SUPERIORITY|||||||0.01|||||||Wilcoxon (Mann-Whitney)|||PACU||||0.010
72553195|NCT02242201|144637824|SUPERIORITY|||||||0.516|||||||Wilcoxon (Mann-Whitney)|||PACU||||0.516
72553196|NCT02242201|144637824|SUPERIORITY|||||||0.052|||||||Wilcoxon (Mann-Whitney)|||PACU||||0.052
72553197|NCT02242201|144637824|SUPERIORITY|||||||0.84|||||||Wilcoxon (Mann-Whitney)|||POD 0 post PACU||||0.840
72553198|NCT02242201|144637824|SUPERIORITY|||||||0.744|||||||Wilcoxon (Mann-Whitney)|||POD 0 post PACU||||0.744
72553199|NCT02242201|144637824|SUPERIORITY|||||||0.501|||||||Wilcoxon (Mann-Whitney)|||POD 0 post PACU||||0.501
72553200|NCT02242201|144637824|SUPERIORITY|||||||0.358|||||||Wilcoxon (Mann-Whitney)|||POD 1||||0.358
72553201|NCT02242201|144637824|SUPERIORITY|||||||0.536|||||||Wilcoxon (Mann-Whitney)|||POD 1||||0.536
72553202|NCT02242201|144637824|SUPERIORITY|||||||0.11|||||||Wilcoxon (Mann-Whitney)|||POD 1||||0.110
72553203|NCT02242201|144637824|SUPERIORITY|||||||0.313|||||||Wilcoxon (Mann-Whitney)|||POD 2||||0.313
72553204|NCT02242201|144637824|SUPERIORITY|||||||0.893|||||||Wilcoxon (Mann-Whitney)|||POD 2||||0.893
72553205|NCT02242201|144637824|SUPERIORITY|||||||0.232|||||||Wilcoxon (Mann-Whitney)|||POD 2||||0.232
72553206|NCT02242201|144637825|SUPERIORITY|||||||0.772|||||||Kruskal-Wallis|||||||0.772
72553207|NCT02242201|144637826|SUPERIORITY|||||||0.251|||||||Regression, Cox|||Baseline||||0.251
72553208|NCT02242201|144637826|SUPERIORITY|||||||0.3|||||||Regression, Cox|||3 month follow-up||||0.300
72553209|NCT02242201|144637826|SUPERIORITY|||||||0.113|||||||Regression, Cox|||Baseline vs 3 months||||0.113
72553210|NCT02242201|144637826|SUPERIORITY|||||||0.147|||||||Regression, Cox|||Baseline vs 3 months||||0.147
72553211|NCT02242201|144637826|SUPERIORITY|||||||0.216|||||||Regression, Cox|||Baseline vs 3 months||||0.216
72553212|NCT02242201|144637826|SUPERIORITY|||||||0.968|||||||Regression, Cox|||Baseline vs 3 months||||0.968
72553213|NCT02242201|144637827|SUPERIORITY|||||||0.776|||||||Kruskal-Wallis|||Pain at rest||||0.776
72553214|NCT02242201|144637827|SUPERIORITY|||||||0.447|||||||Kruskal-Wallis|||Pain with movement||||0.447
72553215|NCT02242201|144637828|SUPERIORITY|||||||0.986|||||||ANOVA|||||||0.986
72553216|NCT02242201|144637828|SUPERIORITY||||||<|0.001|||||||t-test, 1 sided|||Baseline vs 3 months||||<0.001
72553217|NCT02242201|144637828|SUPERIORITY||||||<|0.001|||||||t-test, 1 sided|||Baseline vs 3 months||||<0.001
72553218|NCT02242201|144637828|SUPERIORITY||||||<|0.001|||||||t-test, 1 sided|||Baseline vs 3 months||||<0.001
72553219|NCT02242201|144637829|SUPERIORITY|||||||0.898|||||||ANOVA|||||||0.898
72553220|NCT02242201|144637829|SUPERIORITY|||||||0.112|||||||t-test, 1 sided|||Baseline vs 3 months||||0.112
72553221|NCT02242201|144637829|SUPERIORITY|||||||0.046|||||||t-test, 1 sided|||Baseline vs 3 months||||0.046
72553222|NCT02242201|144637829|SUPERIORITY|||||||0.026|||||||t-test, 1 sided|||Baseline vs 3 months||||0.026
72553223|NCT02242201|144637830|SUPERIORITY|||||||0.843|||||||Fisher Exact|||Operative extremity neurologic changes||||0.843
72553224|NCT02242201|144637830|SUPERIORITY|||||||1|||||||Fisher Exact|||Wound infection||||1.00
72553225|NCT02242201|144637830|SUPERIORITY|||||||1|||||||Fisher Exact|||Fall requiring medical attention||||1.00
72553226|NCT02242201|144637831|SUPERIORITY|||||||1|||||||Fisher Exact|||Pain at rest||||1.00
72553227|NCT02242201|144637831|SUPERIORITY|||||||0.167|||||||Fisher Exact|||Pain with movement||||0.167
72553228|NCT00017953|144637832|SUPERIORITY||Hazard Ratio (HR)|0.95||||0.51|TWO_SIDED|95.0|0.83|1.09|||Regression, Cox|||||1.09|0.83|0.51
72553229|NCT00017953|144637833|SUPERIORITY||Hazard Ratio (HR)|0.93||||0.42|TWO_SIDED|95.0|0.79|1.1|||Regression, Cox|||||1.10|0.79|0.42
72553230|NCT00017953|144637834|SUPERIORITY||Hazard Ratio (HR)|0.93||||0.23|TWO_SIDED|95.0|0.82|1.05|||Regression, Cox|||||1.05|0.82|0.23
72553231|NCT00017953|144637835|SUPERIORITY||Hazard Ratio (HR)|0.94||||0.29|TWO_SIDED|95.0|0.84|1.05|||Regression, Cox|||||1.05|0.84|0.29
72553232|NCT02374853|144637841|SUPERIORITY|||||||0.23|||||||Fisher Exact|||||||0.23
72553233|NCT02374853|144637842|SUPERIORITY|||||||0.25|||||||Fisher Exact|||||||0.25
72553234|NCT02374853|144637843|SUPERIORITY|||||||0.054|||||||Wilcoxon (Mann-Whitney)|||||||.054
72553235|NCT01424644|144637875|NON_INFERIORITY_OR_EQUIVALENCE|The immune response to diphtheria toxin for the MenACWY-CRM+Tdap+HPV group was considered non-inferior to that of the Placebo+Tdap+HPV group if the lower limit of the two-sided 95% CI of the difference in seroprotection rates \[(MenACWY-CRM+Tdap+HPV) minus (Placebo+Tdap + HPV)\] was greater than -10%, at 1 month after Tdap vaccination|Vaccine group difference|13.0|||||TWO_SIDED|95.0|9.0|17.0|||Miettinen and Nurminen|||Non-inferiority of anti-diphtheria immune response following concomitant administration of Tdap with HPV and MenACWY-CRM as compared to concomitant administration of Tdap with HPV and placebo||17|9|
72553236|NCT01424644|144637875|NON_INFERIORITY_OR_EQUIVALENCE|The immune response to tetanus toxin for the MenACWY-CRM+Tdap+HPV group was considered non-inferior to that of Placebo+Tdap+HPV group if the lower limit of the two-sided 95% CI of the difference in seroprotection rates \[(MenACWY-CRM+ Tdap+HPV) minus (Placebo+Tdap + HPV)\] was greater than -10%, at 1 month after Tdap vaccination.|Vaccine group difference|0.0|||||TWO_SIDED|95.0|-2.0|2.0|||Miettinen and Nurminen|||Non-inferiority of anti-tetanus immune response following concomitant administration of Tdap with HPV and MenACWY-CRM as compared to concomitant administration of Tdap with HPV and placebo.||2|-2|
72553237|NCT01424644|144637876|NON_INFERIORITY_OR_EQUIVALENCE|The immune response to PT antigen for the MenACWY-CRM+Tdap+HPV group was considered non-inferior to that of the Placebo+Tdap+HPV group if the lower limit of the two-sided 95% CI of the ratio of the GMCs of the MenACWY-CRM +Tdap+HPV group to the Placebo+Tdap + HPV group was greater than 0.5, at 1 month after Tdap vaccination.|Vaccine group ratio-Geometric mean conc|1.01|||||TWO_SIDED|95.0|0.89|1.14|||ANOVA|||Non-inferiority of anti-PT immune response following concomitant administration of Tdap with HPV and MenACWY-CRM as compared to concomitant administration of Tdap with HPV and placebo.||1.14|0.89|
72553238|NCT01424644|144637876|NON_INFERIORITY_OR_EQUIVALENCE|The immune response to FHA antigen for the MenACWY-CRM+Tdap+HPV group was considered non-inferior to that of Placebo+Tdap+HPV group if the lower limit of the 95% CI of the difference \[(MenACWY-CRM +Tdap+HPV) minus(Placebo+Tdap + HPV)\] was greater than 0.5, at 1 month after Tdap vaccination.|Vaccine group ratio- Geometric mean conc|0.84|||||TWO_SIDED|95.0|0.76|0.93|||ANOVA|||Non-inferiority of anti-FHA immune response following concomitant administration of Tdap with HPV and MenACWY-CRM as compared to concomitant administration of Tdap with HPV and placebo.||0.93|0.76|
72553239|NCT01424644|144637876|NON_INFERIORITY_OR_EQUIVALENCE|The immune response to PRN antigen for the MenACWY-CRM+Tdap+HPV group was considered non-inferior to that of Placebo+Tdap+HPV group if the lower limit of the 95% CI of the difference \[(MenACWY-CRM+Tdap+HPV) minus(Placebo+Tdap + HPV)\] was greater than 0.5, at 1 month after vaccination.|Vaccine group ratio-Geometric mean conc|0.82|||||TWO_SIDED|95.0|0.72|0.93|||ANOVA|||Non-inferiority of anti-PRN immune response following concomitant administration of Tdap with HPV and MenACWY-CRM as compared to concomitant administration of Tdap with HPV and placebo.||0.93|0.72|
72553240|NCT01077596|144637882|SUPERIORITY_OR_OTHER||Crude Odds Ratio|1.2||||||95.0|1.1|1.3||||||||1.3|1.1|
72553241|NCT01077596|144637882|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.1||||||95.0|1.0|1.2|||||Adjusted for age, sex, cal year, study site, tumor characteristics, multiple antidepressants exposure, smoking, hysterectomy status, previous depression dx, previous IBD diagnosis, OC use, HRT/ERT use, and NSAID use.|||1.2|1.0|
72553242|NCT01077596|144637882|SUPERIORITY_OR_OTHER||Crude Odds Ratio|1.2||||||95.0|1.1|1.3||||||||1.3|1.1|
72553243|NCT01077596|144637882|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.1||||||95.0|1.0|1.2|||||Adjusted for age, sex, cal year, study site, tumor characteristics, multiple antidepressants exposure, smoking, hysterectomy status, previous depression dx, previous IBD diagnosis, OC use, HRT/ERT use, and NSAID use.|||1.2|1.0|
72553244|NCT01077596|144637882|SUPERIORITY_OR_OTHER||Crude Odds Ratio|1.2||||||95.0|1.0|1.3||||||||1.3|1.0|
72553245|NCT01077596|144637882|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.1||||||95.0|1.0|1.2|||||Adjusted for age, sex, cal year, study site, tumor characteristics, multiple antidepressants exposure, smoking, hysterectomy status, previous depression dx, previous IBD diagnosis, OC use, HRT/ERT use, and NSAID use.|||1.2|1.0|
72367145|NCT02952820|144245013|SUPERIORITY||LSGM ratio|0.81|||<|0.0001|TWO_SIDED|95.0|0.735|0.893|||Mixed Models Analysis|||Month 1 (Statistical analysis 3): Based on MMRM model with log transformation of sSOL and factors for age group, region, treatment, visit (Month 1), and treatment-by-visit interaction as fixed effects, and the study baseline sSOL as a covariate. Missing values are imputed using multiple imputation and assumed to be missing not at random (MNAR/CCMV).||0.893|0.735|<.0001
72367146|NCT02952820|144245013|SUPERIORITY||LSGM ratio|0.77|||<|0.0001|TWO_SIDED|95.0|0.698|0.848|||Mixed Models Analysis|||Month 1 (Statistical analysis 4): Based on MMRM model with log transformation of sSOL and factors for age group, region, treatment, visit (Month 1), and treatment-by-visit interaction as fixed effects, and the study baseline sSOL as a covariate. Missing values are imputed using multiple imputation and assumed to be missing not at random (MNAR/CCMV).||0.848|0.698|<.0001
72367147|NCT02952820|144245013|SUPERIORITY||LSGM ratio|0.778|||<|0.0001|TWO_SIDED|95.0|0.69|0.878|||Mixed Models Analysis|||Month 3 (Statistical analysis 5): Based on MMRM model with log transformation of sSOL and factors for age group, region, treatment, visit (Month 3), and treatment-by-visit interaction as fixed effects, and the study baseline sSOL as a covariate. Missing values are imputed using multiple imputation and assumed to be missing not at random (MNAR/CCMV).||0.878|0.690|<.0001
72367148|NCT02952820|144245013|SUPERIORITY||LSGM ratio|0.77|||<|0.0001|TWO_SIDED|95.0|0.681|0.869|||Mixed Models Analysis|||Month 3 (Statistical analysis 6): Based on MMRM model with log transformation of sSOL and factors for age group, region, treatment, visit (Month 3), and treatment-by-visit interaction as fixed effects, and the study baseline sSOL as a covariate. Missing values are imputed using multiple imputation and assumed to be missing not at random (MNAR/CCMV).||0.869|0.681|<.0001
72367149|NCT02952820|144245014|SUPERIORITY||LSM Difference|4.299|STANDARD_ERROR_OF_MEAN|0.848|<|0.0001|TWO_SIDED|95.0|2.638|5.961|||Mixed Models Analysis|||First 7 nights (Statistical analysis 1): Based on MMRM model with factors of age group, region, treatment, visit (First 7 nights), and treatment-by-visit interaction as fixed effect, and the study baseline sSE as a covariate. Missing values are imputed using multiple imputation and assumed to be missing not at random (MNAR/CCMV).||5.961|2.638|<.0001
72367150|NCT02952820|144245014|SUPERIORITY||LSM Difference|5.793|STANDARD_ERROR_OF_MEAN|0.846|<|0.0001|TWO_SIDED|95.0|4.133|7.452|||Mixed Models Analysis|||First 7 nights (Statistical analysis 2): Based on MMRM model with factors of age group, region, treatment, visit (First 7 nights), and treatment-by-visit interaction as fixed effect, and the study baseline sSE as a covariate. Missing values are imputed using multiple imputation and assumed to be missing not at random (MNAR/CCMV).||7.452|4.133|<.0001
72367151|NCT02952820|144245014|SUPERIORITY||LSM Difference|2.227|STANDARD_ERROR_OF_MEAN|0.979||0.023|TWO_SIDED|95.0|0.307|4.146|||Mixed Models Analysis|||Month 1 (Statistical analysis 3): Based on MMRM model with factors of age group, region, treatment, visit (Month 1), and treatment-by-visit interaction as fixed effect, and the study baseline sSE as a covariate. Missing values are imputed using multiple imputation and assumed to be missing not at random (MNAR/CCMV).||4.146|0.307|0.0230
72367152|NCT02952820|144245014|SUPERIORITY||LSM Difference|3.615|STANDARD_ERROR_OF_MEAN|1.01||0.0003|TWO_SIDED|95.0|1.635|5.595|||Mixed Models Analysis|||Month 1 (Statistical analysis 4): Based on MMRM model with factors of age group, region, treatment, visit (Month 1), and treatment-by-visit interaction as fixed effect, and the study baseline sSE as a covariate. Missing values are imputed using multiple imputation and assumed to be missing not at random (MNAR/CCMV).||5.595|1.635|0.0003
72367153|NCT02952820|144245014|SUPERIORITY||LSM Difference|4.222|STANDARD_ERROR_OF_MEAN|1.099||0.0001|TWO_SIDED|95.0|2.068|6.377|||Mixed Models Analysis|||Month 3 (Statistical analysis 5): Based on MMRM model with factors of age group, region, treatment, visit (Month 3), and treatment-by-visit interaction as fixed effect, and the study baseline sSE as a covariate. Missing values are imputed using multiple imputation and assumed to be missing not at random (MNAR/CCMV).||6.377|2.068|0.0001
72367154|NCT02952820|144245014|SUPERIORITY||LSM Difference|4.361|STANDARD_ERROR_OF_MEAN|1.092|<|0.0001|TWO_SIDED|95.0|2.22|6.501|||Mixed Models Analysis|||Month 3 (Statistical analysis 6): Based on MMRM model with factors of age group, region, treatment, visit (Month 3), and treatment-by-visit interaction as fixed effect, and the study baseline sSE as a covariate. Missing values are imputed using multiple imputation and assumed to be missing not at random (MNAR/CCMV).||6.501|2.220|<.0001
72367155|NCT02952820|144245014|SUPERIORITY||LSM Difference|4.549|STANDARD_ERROR_OF_MEAN|1.179||0.0001|TWO_SIDED|95.0|2.236|6.861|||Mixed Models Analysis|||Month 6 (Statistical analysis 7): Based on MMRM model with factors of age group, region, treatment, visit (Month 6), and treatment-by-visit interaction as fixed effect, and the study baseline sSE as a covariate. Missing values are imputed using multiple imputation and assumed to be missing not at random (MNAR/CCMV).||6.861|2.236|0.0001
72367156|NCT02952820|144245014|SUPERIORITY||LSM Difference|4.667|STANDARD_ERROR_OF_MEAN|1.17|<|0.0001|TWO_SIDED|95.0|2.373|6.96|||Mixed Models Analysis|||Month 6 (Statistical analysis 8): Based on MMRM model with factors of age group, region, treatment, visit (Month 6), and treatment-by-visit interaction as fixed effect, and the study baseline sSE as a covariate. Missing values are imputed using multiple imputation and assumed to be missing not at random (MNAR/CCMV).||6.960|2.373|<.0001
72367157|NCT02952820|144245015|SUPERIORITY||Least square mean (LSM) Difference|-14.328|STANDARD_ERROR_OF_MEAN|3.614|<|0.0001|TWO_SIDED|95.0|-21.411|-7.245|||Mixed Models Analysis|||First 7 nights (Statistical analysis 1): Based on MMRM model with factors of age group, region, treatment, visit (First 7 nights), and treatment-by-visit interaction as fixed effect, and the study baseline sWASO as a covariate. Missing values are imputed using multiple imputation and assumed to be missing not at random (MNAR/CCMV).||-7.245|-21.411|<.0001
72367158|NCT02952820|144245015|SUPERIORITY||LSM Difference|-16.72|STANDARD_ERROR_OF_MEAN|3.619|<|0.0001|TWO_SIDED|95.0|-23.813|-9.626|||Mixed Models Analysis|||First 7 nights (Statistical analysis 2): Based on MMRM model with factors of age group, region, treatment, visit (First 7 nights), and treatment-by-visit interaction as fixed effect, and the study baseline sWASO as a covariate. Missing values are imputed using multiple imputation and assumed to be missing not at random (MNAR/CCMV).||-9.626|-23.813|<.0001
72367159|NCT02952820|144245015|SUPERIORITY||LSM Difference|-5.514|STANDARD_ERROR_OF_MEAN|4.109||0.1796|TWO_SIDED|95.0|-13.568|2.54|||Mixed Models Analysis|||Month 1 (Statistical analysis 3): Based on MMRM model with factors of age group, region, treatment, visit (Month 1), and treatment-by-visit interaction as fixed effect, and the study baseline sWASO as a covariate. Missing values are imputed using multiple imputation and assumed to be missing not at random (MNAR/CCMV).||2.540|-13.568|0.1796
72553246|NCT01077596|144637882|SUPERIORITY_OR_OTHER||Crude Odds Ratio|1.2||||||95.0|1.1|1.4||||||||1.4|1.1|
72553247|NCT01077596|144637882|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.2||||||95.0|1.0|1.3|||||Adjusted for age, sex, cal year, study site, tumor characteristics, multiple antidepressants exposure, smoking, hysterectomy status, previous depression dx, previous IBD diagnosis, OC use, HRT/ERT use, and NSAID use.|||1.3|1.0|
72553248|NCT01077596|144637883|SUPERIORITY_OR_OTHER||Crude Odds Ratio|1.4||||||95.0|0.9|2.2||||||||2.2|0.9|
72553249|NCT01077596|144637883|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.2||||||95.0|0.8|2.0|||||Adjusted for age, sex, cal year, study site, tumor characteristics, multiple antidepressants exposure, smoking, hysterectomy status, previous depression dx, previous IBD diagnosis, OC use, HRT/ERT use, and NSAID use.|||2.0|0.8|
72553250|NCT01077596|144637883|SUPERIORITY_OR_OTHER||Crude Odds Ratio|1.2||||||95.0|0.8|2.0||||||||2.0|0.8|
72553251|NCT01077596|144637883|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.1||||||95.0|0.7|1.9|||||Adjusted for age, sex, cal year, study site, tumor characteristics, multiple antidepressants exposure, smoking, hysterectomy status, previous depression dx, previous IBD diagnosis, OC use, HRT/ERT use, and NSAID use.|||1.9|0.7|
72553252|NCT01077596|144637883|SUPERIORITY_OR_OTHER||Crude Odds Ratio|1.3||||||95.0|0.8|2.1||||||||2.1|0.8|
72553253|NCT01077596|144637883|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.1||||||95.0|0.7|1.9|||||Adjusted for age, sex, cal year, study site, tumor characteristics, multiple antidepressants exposure, smoking, hysterectomy status, previous depression dx, previous IBD diagnosis, OC use, HRT/ERT use, and NSAID use.|||1.9|0.7|
72553254|NCT01077596|144637883|SUPERIORITY_OR_OTHER||Crude Odds Ratio|2.2||||||95.0|1.2|3.9||||||||3.9|1.2|
72553255|NCT01077596|144637883|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|2.0||||||95.0|1.1|3.6|||||Adjusted for age, sex, cal year, study site, tumor characteristics, multiple antidepressants exposure, smoking, hysterectomy status, previous depression dx, previous IBD diagnosis, OC use, HRT/ERT use, and NSAID use.|||3.6|1.1|
72553256|NCT01077596|144637884|SUPERIORITY_OR_OTHER||Crude Odds Ratio|4.5||||||95.0|3.2|6.3||||||||6.3|3.2|
72553257|NCT01077596|144637884|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|3.0||||||95.0|2.0|4.4|||||Adjusted for age, sex, cal year, study site, tumor characteristics, multiple antidepressants exposure, smoking, hysterectomy status, previous depression dx, previous IBD diagnosis, OC use, HRT/ERT use, and NSAID use.|||4.4|2.0|
72553258|NCT01077596|144637884|SUPERIORITY_OR_OTHER||Crude Odds Ratio|4.0||||||95.0|2.8|5.8||||||||5.8|2.8|
72553259|NCT01077596|144637884|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|2.9||||||95.0|1.9|4.5|||||Adjusted for age, sex, cal year, study site, tumor characteristics, multiple antidepressants exposure, smoking, hysterectomy status, previous depression dx, previous IBD diagnosis, OC use, HRT/ERT use, and NSAID use.|||4.5|1.9|
72553260|NCT01077596|144637884|SUPERIORITY_OR_OTHER||Crude Odds Ratio|4.4||||||95.0|3.1|6.3||||||||6.3|3.1|
72553261|NCT01077596|144637884|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|3.0||||||95.0|1.9|4.5|||||Adjusted for age, sex, cal year, study site, tumor characteristics, multiple antidepressants exposure, smoking, hysterectomy status, previous depression dx, previous IBD diagnosis, OC use, HRT/ERT use, and NSAID use.|||4.5|1.9|
72553262|NCT01077596|144637884|SUPERIORITY_OR_OTHER||Crude Odds Ratio|4.5||||||95.0|2.8|7.2||||||||7.2|2.8|
72553263|NCT01077596|144637884|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|3.5||||||95.0|2.1|5.9|||||Adjusted for age, sex, cal year, study site, tumor characteristics, multiple antidepressants exposure, smoking, hysterectomy status, previous depression dx, previous IBD diagnosis, OC use, HRT/ERT use, and NSAID use.|||5.9|2.1|
72553264|NCT01077596|144637885|SUPERIORITY_OR_OTHER||Crude Odds Ratio|2.6||||||95.0|1.7|4.1||||||||4.1|1.7|
72553265|NCT01077596|144637885|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|2.1||||||95.0|1.3|3.4|||||Adjusted for age, sex, cal year, study site, tumor characteristics, multiple antidepressants exposure, smoking, hysterectomy status, previous depression dx, previous IBD diagnosis, OC use, HRT/ERT use, and NSAID use.|||3.4|1.3|
72553266|NCT01077596|144637885|SUPERIORITY_OR_OTHER||Crude Odds Ratio|2.3||||||95.0|1.4|3.6||||||||3.6|1.4|
72553267|NCT01077596|144637885|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.8||||||95.0|1.1|3.0|||||Adjusted for age, sex, cal year, study site, tumor characteristics, multiple antidepressants exposure, smoking, hysterectomy status, previous depression dx, previous IBD diagnosis, OC use, HRT/ERT use, and NSAID use.|||3.0|1.1|
72553268|NCT01077596|144637885|SUPERIORITY_OR_OTHER||Crude Odds Ratio|2.3||||||95.0|1.5|3.7||||||||3.7|1.5|
72553269|NCT01077596|144637885|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.8||||||95.0|1.1|3.0|||||Adjusted for age, sex, cal year, study site, tumor characteristics, multiple antidepressants exposure, smoking, hysterectomy status, previous depression dx, previous IBD diagnosis, OC use, HRT/ERT use, and NSAID use.|||3.0|1.1|
72553270|NCT01077596|144637885|SUPERIORITY_OR_OTHER||Crude Odds Ratio|2.6||||||95.0|1.5|4.5||||||||4.5|1.5|
72553271|NCT01077596|144637885|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|2.2||||||95.0|1.3|3.9|||||Adjusted for age, sex, cal year, study site, tumor characteristics, multiple antidepressants exposure, smoking, hysterectomy status, previous depression dx, previous IBD diagnosis, OC use, HRT/ERT use, and NSAID use.|||3.9|1.3|
72553272|NCT01077596|144637886|SUPERIORITY_OR_OTHER||Crude Odds Ratio|0.8||||||95.0|0.5|1.3||||||||1.3|0.5|
72553273|NCT01077596|144637886|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|0.7||||||95.0|0.4|1.2|||||Adjusted for age, sex, cal year, study site, tumor characteristics, multiple antidepressants exposure, smoking, hysterectomy status, previous depression dx, previous IBD diagnosis, OC use, HRT/ERT use, and NSAID use.|||1.2|0.4|
72553274|NCT01077596|144637886|SUPERIORITY_OR_OTHER||Crude Odds Ratio|0.6||||||95.0|0.4|1.1||||||||1.1|0.4|
72553275|NCT01077596|144637886|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|0.6||||||95.0|0.3|1.0|||||Adjusted for age, sex, cal year, study site, tumor characteristics, multiple antidepressants exposure, smoking, hysterectomy status, previous depression dx, previous IBD diagnosis, OC use, HRT/ERT use, and NSAID use.|||1.0|0.3|
72553276|NCT01077596|144637886|SUPERIORITY_OR_OTHER||Crude Odds Ratio|0.8||||||95.0|0.5|1.4||||||||1.4|0.5|
72553277|NCT01077596|144637886|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|0.8||||||95.0|0.4|1.4|||||Adjusted for age, sex, cal year, study site, tumor characteristics, multiple antidepressants exposure, smoking, hysterectomy status, previous depression dx, previous IBD diagnosis, OC use, HRT/ERT use, and NSAID use.|||1.4|0.4|
72553278|NCT01077596|144637886|SUPERIORITY_OR_OTHER||Crude Odds Ratio|1.1||||||95.0|0.6|2.0||||||||2.0|0.6|
72553279|NCT01077596|144637886|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.0||||||95.0|0.6|1.9|||||Adjusted for age, sex, cal year, study site, tumor characteristics, multiple antidepressants exposure, smoking, hysterectomy status†, previous depression dx, previous IBD‡ diagnosis, OC§ use, HRT/ERT use, and NSAID use.|||1.9|0.6|
72367160|NCT02952820|144245015|SUPERIORITY||LSM Difference|-7.005|STANDARD_ERROR_OF_MEAN|4.129||0.0898|TWO_SIDED|95.0|-15.098|1.088|||Mixed Models Analysis|||Month 1 (Statistical analysis 4): Based on MMRM model with factors of age group, region, treatment, visit (Month 1), and treatment-by-visit interaction as fixed effect, and the study baseline sWASO as a covariate. Missing values are imputed using multiple imputation and assumed to be missing not at random (MNAR/CCMV).||1.088|-15.098|0.0898
72367161|NCT02952820|144245015|SUPERIORITY||LSM Difference|-13.424|STANDARD_ERROR_OF_MEAN|4.486||0.0028|TWO_SIDED|95.0|-22.218|-4.631|||Mixed Models Analysis|||Month 3 (Statistical analysis 5): Based on MMRM model with factors of age group, region, treatment, visit (Month 3), and treatment-by-visit interaction as fixed effect, and the study baseline sWASO as a covariate. Missing values are imputed using multiple imputation and assumed to be missing not at random (MNAR/CCMV).||-4.631|-22.218|0.0028
72367162|NCT02952820|144245015|SUPERIORITY||LSM Difference|-10.079|STANDARD_ERROR_OF_MEAN|4.578||0.0277|TWO_SIDED|95.0|-19.053|-1.104|||Mixed Models Analysis|||Month 3 (Statistical analysis 6): Based on MMRM model with factors of age group, region, treatment, visit (Month 3), and treatment-by-visit interaction as fixed effect, and the study baseline sWASO as a covariate. Missing values are imputed using multiple imputation and assumed to be missing not at random (MNAR/CCMV).||-1.104|-19.053|0.0277
72367163|NCT02952820|144245015|SUPERIORITY||LSM Difference|-17.474|STANDARD_ERROR_OF_MEAN|5.014||0.0005|TWO_SIDED|95.0|-27.306|-7.643|||Mixed Models Analysis|||Month 6 (Statistical analysis 7): Based on MMRM model with factors of age group, region, treatment, visit (Month 6), and treatment-by-visit interaction as fixed effect, and the study baseline sWASO as a covariate. Missing values are imputed using multiple imputation and assumed to be missing not at random (MNAR/CCMV).||-7.643|-27.306|0.0005
72367164|NCT02952820|144245015|SUPERIORITY||LSM Difference|-12.671|STANDARD_ERROR_OF_MEAN|4.951||0.0105|TWO_SIDED|95.0|-22.378|-2.964|||Mixed Models Analysis|||Month 6 (Statistical analysis 8): Based on MMRM model with factors of age group, region, treatment, visit (Month 6), and treatment-by-visit interaction as fixed effect, and the study baseline sWASO as a covariate. Missing values are imputed using multiple imputation and assumed to be missing not at random (MNAR/CCMV).||-2.964|-22.378|0.0105
72367165|NCT02952820|144245016|SUPERIORITY||LSM Difference|22.034|STANDARD_ERROR_OF_MEAN|4.354|<|0.0001|TWO_SIDED|95.0|13.488|30.579|||Mixed Models Analysis|||First 7 Nights After the First Dose (Statistical analysis 1): Based on MMRM model with factors of age group, region, treatment, visit (First 7 nights), and treatment-by-visit interaction as fixed effect, and the study baseline sTST as a covariate. Missing values are not imputed and assumed to be MAR.||30.579|13.488|<.0001
72367166|NCT02952820|144245016|SUPERIORITY||LSM Difference|31.796|STANDARD_ERROR_OF_MEAN|4.35|<|0.0001|TWO_SIDED|95.0|23.258|40.334|||Mixed Models Analysis|||First 7 nights after the first dose (Statistical analysis 2): Based on MMRM model with factors of age group, region, treatment, visit (First 7 nights), and treatment-by-visit interaction as fixed effect, and the study baseline sTST as a covariate. Missing values are not imputed and assumed to be MAR.||40.334|23.258|<.0001
72367167|NCT02952820|144245016|SUPERIORITY||LSM Difference|11.76|STANDARD_ERROR_OF_MEAN|5.269||0.0259|TWO_SIDED|95.0|1.418|22.102|||Mixed Models Analysis|||Month 1 (Statistical analysis 3): Based on MMRM model with factors of age group, region, treatment, visit (Month 1), and treatment-by-visit interaction as fixed effect, and the study baseline sTST as a covariate. Missing values are not imputed and assumed to be MAR.||22.102|1.418|0.0259
72367168|NCT02952820|144245016|SUPERIORITY||LSM Difference|22.131|STANDARD_ERROR_OF_MEAN|5.286|<|0.0001|TWO_SIDED|95.0|11.757|32.505|||Mixed Models Analysis|||Month 1 (Statistical analysis 4): Based on MMRM model with factors of age group, region, treatment, visit (Month 1), and treatment-by-visit interaction as fixed effect, and the study baseline sTST as a covariate. Missing values are not imputed and assumed to be MAR.||32.505|11.757|<.0001
72367169|NCT02952820|144245016|SUPERIORITY||LSM Difference|17.374|STANDARD_ERROR_OF_MEAN|5.906||0.0034|TWO_SIDED|95.0|5.781|28.968|||Mixed Models Analysis|||Month 3 (Statistical analysis 5): Based on MMRM model with factors of age group, region, treatment, visit (Month 3), and treatment-by-visit interaction as fixed effect, and the study baseline sTST as a covariate. Missing values are not imputed and assumed to be MAR.||28.968|5.781|0.0034
72367170|NCT02952820|144245016|SUPERIORITY||LSM Difference|21.686|STANDARD_ERROR_OF_MEAN|5.946||0.0003|TWO_SIDED|95.0|10.014|33.359|||Mixed Models Analysis|||Month 3 (Statistical analysis 6): Based on MMRM model with factors of age group, region, treatment, visit (Month 3), and treatment-by-visit interaction as fixed effect, and the study baseline sTST as a covariate. Missing values are not imputed and assumed to be MAR.||33.359|10.014|0.0003
72367171|NCT02952820|144245016|SUPERIORITY||LSM Difference|18.555|STANDARD_ERROR_OF_MEAN|6.324||0.0034|TWO_SIDED|95.0|6.14|30.969|||Mixed Models Analysis|||Month 6 (Statistical analysis 7): Based on MMRM model with factors of age group, region, treatment, visit (Month 6), and treatment-by-visit interaction as fixed effect, and the study baseline sTST as a covariate. Missing values are not imputed and assumed to be missing at random (MAR).||30.969|6.140|0.0034
72367172|NCT02952820|144245016|SUPERIORITY||LSM Difference|22.686|STANDARD_ERROR_OF_MEAN|6.392||0.0004|TWO_SIDED|95.0|10.137|35.234|||Mixed Models Analysis|||Month 6 (Statistical analysis 8): Based on MMRM model with factors of age group, region, treatment, visit (Month 6), and treatment-by-visit interaction as fixed effect, and the study baseline sTST as a covariate. Missing values are not imputed and assumed to be MAR.||35.234|10.137|0.0004
72367173|NCT02952820|144245017|SUPERIORITY||Difference of percentage|13.67||||0.0004|TWO_SIDED|95.0|6.24|21.1|||Cochran-Mantel-Haenszel|||Sleep onset responders: Statistical analysis 1||21.10|6.24|0.0004
72367174|NCT02952820|144245017|SUPERIORITY||Difference of percentage|12.53||||0.0009|TWO_SIDED|95.0|5.2|19.86|||Cochran-Mantel-Haenszel|||Sleep Onset Responders: Statistical analysis 2||19.86|5.20|0.0009
72367175|NCT02952820|144245017|SUPERIORITY||Difference of percentage|14.65||||0.0002|TWO_SIDED|95.0|6.97|22.33|||Cochran-Mantel-Haenszel|||Sleep Maintenance Responders: Statistical analysis 3||22.33|6.97|0.0002
72367176|NCT02952820|144245017|SUPERIORITY||Difference of percentage|9.82||||0.011|TWO_SIDED|95.0|2.29|17.35|||Cochran-Mantel-Haenszel|||Sleep Maintenance Responders: Statistical analysis 4||17.35|2.29|0.0110
72367177|NCT02952820|144245019|SUPERIORITY||LSM Difference|-0.71|STANDARD_ERROR_OF_MEAN|0.287||0.0137|TWO_SIDED|95.0|-1.27|-0.15|||Mixed Models Analysis|||Month 1 (Statistical analysis 1): Based on MMRM model with factors for age group, region, treatment, visit (Month 1), and treatment-by-visit interaction as fixed effects, and study baseline ISI score as a covariate. Missing values are not imputed and assumed to be MAR.||-0.15|-1.27|0.0137
72553280|NCT01077596|144637887|SUPERIORITY_OR_OTHER||Crude Odds Ratio|0.9||||||95.0|0.8|1.1||||||||1.1|0.8|
72367178|NCT02952820|144245019|SUPERIORITY||LSM Difference|-0.94|STANDARD_ERROR_OF_MEAN|0.289||0.0011|TWO_SIDED|95.0|-1.51|-0.38|||Mixed Models Analysis|||Month 1 (Statistical analysis 2): Based on MMRM model with factors for age group, region, treatment, visit (Month 1), and treatment-by-visit interaction as fixed effects, and study baseline ISI score as a covariate. Missing values are not imputed and assumed to be MAR.||-0.38|-1.51|0.0011
72367179|NCT02952820|144245019|SUPERIORITY||LSM Difference|-1.16|STANDARD_ERROR_OF_MEAN|0.302||0.0001|TWO_SIDED|95.0|-1.75|-0.57|||Mixed Models Analysis|||Month 3 (Statistical analysis 3): Based on MMRM model with factors for age group, region, treatment, visit (Month 3), and treatment-by-visit interaction as fixed effects, and study baseline ISI score as a covariate. Missing values are not imputed and assumed to be MAR.||-0.57|-1.75|0.0001
72367180|NCT02952820|144245019|SUPERIORITY||LSM Difference|-1.36|STANDARD_ERROR_OF_MEAN|0.305|<|0.0001|TWO_SIDED|95.0|-1.96|-0.76|||Mixed Models Analysis|||Month 3 (Statistical analysis 4): Based on MMRM model with factors for age group, region, treatment, visit (Month 3), and treatment-by-visit interaction as fixed effects, and study baseline ISI score as a covariate. Missing values are not imputed and assumed to be MAR.||-0.76|-1.96|<.0001
72367181|NCT02952820|144245019|SUPERIORITY||LSM Difference|-1.3|STANDARD_ERROR_OF_MEAN|0.302|<|0.0001|TWO_SIDED|95.0|-1.9|-0.71|||Mixed Models Analysis|||Month 6 (Statistical analysis 5): Based on MMRM model with factors for age group, region, treatment, visit (Month 6), and treatment-by-visit interaction as fixed effects, and study baseline ISI score as a covariate. Missing values are not imputed and assumed to be MAR.||-0.71|-1.90|<.0001
72367182|NCT02952820|144245019|SUPERIORITY||LSM Difference|-1.32|STANDARD_ERROR_OF_MEAN|0.307|<|0.0001|TWO_SIDED|95.0|-1.92|-0.71|||Mixed Models Analysis|||Month 6 (Statistical analysis 6): Based on MMRM model with factors for age group, region, treatment, visit (Month 6), and treatment-by-visit interaction as fixed effects, and study baseline ISI score as a covariate. Missing values are not imputed and assumed to be MAR.||-0.71|-1.92|<.0001
72367183|NCT02952820|144245020|SUPERIORITY||LSM Difference|-1.66|STANDARD_ERROR_OF_MEAN|0.905||0.067|TWO_SIDED|95.0|-3.44|0.12|||Mixed Models Analysis|||Month 1 (Statistical analysis 1): Based on MMRM model with factors for age group, region, treatment, visit (Month 1), and treatment-by-visit interaction as fixed effects, and study baseline FSS score as a covariate. Missing values are not imputed and assumed to be MAR.||0.12|-3.44|0.0670
72367184|NCT02952820|144245020|SUPERIORITY||LSM Difference|-2.04|STANDARD_ERROR_OF_MEAN|0.913||0.0257|TWO_SIDED|95.0|-3.83|-0.25|||Mixed Models Analysis|||Month 1 (Statistical analysis 2): Based on MMRM model with factors for age group, region, treatment, visit (Month 1), and treatment-by-visit interaction as fixed effects, and study baseline FSS score as a covariate. Missing values are not imputed and assumed to be MAR.||-0.25|-3.83|0.0257
72367185|NCT02952820|144245020|SUPERIORITY||LSM Difference|-2.18|STANDARD_ERROR_OF_MEAN|0.939||0.0206|TWO_SIDED|95.0|-4.02|-0.34|||Mixed Models Analysis|||Month 3 (Statistical analysis 3): Based on MMRM model with factors for age group, region, treatment, visit (Month 3), and treatment-by-visit interaction as fixed effects, and study baseline FSS score as a covariate. Missing values are not imputed and assumed to be MAR.||-0.34|-4.02|0.0206
72367186|NCT02952820|144245020|SUPERIORITY||LSM Difference|-3.04|STANDARD_ERROR_OF_MEAN|0.95||0.0014|TWO_SIDED|95.0|-4.91|-1.18|||Mixed Models Analysis|||Month 3 (Statistical analysis 4): Based on MMRM model with factors for age group, region, treatment, visit (Month 3), and treatment-by-visit interaction as fixed effects, and study baseline FSS score as a covariate. Missing values are not imputed and assumed to be MAR.||-1.18|-4.91|0.0014
72367187|NCT02952820|144245020|SUPERIORITY||LSM Difference|-2.5|STANDARD_ERROR_OF_MEAN|0.112||0.0134|TWO_SIDED|95.0|-4.48|-0.52|||Mixed Models Analysis|||Month 6 (Statistical analysis 5): Based on MMRM model with factors for age group, region, treatment, visit (Month 6), and treatment-by-visit interaction as fixed effects, and study baseline FSS score as a covariate. Missing values are not imputed and assumed to be MAR.||-0.52|-4.48|0.0134
72367188|NCT02952820|144245020|SUPERIORITY||LSM Difference|-2.56|STANDARD_ERROR_OF_MEAN|1.026||0.0128|TWO_SIDED|95.0|-4.57|-0.54|||Mixed Models Analysis|||Month 6 (Statistical analysis 6): Based on MMRM model with factors for age group, region, treatment, visit (Month 6), and treatment-by-visit interaction as fixed effects, and study baseline FSS score as a covariate. Missing values are not imputed and assumed to be MAR.||-0.54|-4.57|0.0128
72367189|NCT02952820|144245021|SUPERIORITY||LSM Difference|0.205|STANDARD_ERROR_OF_MEAN|0.076||0.0067|TWO_SIDED|95.0|0.057|0.353|||Mixed Models Analysis|||First 7 nights (Statistical analysis): Based on MMRM model with factors of age group, region, treatment, visit (First 7 nights), and treatment-by-visit interaction as fixed effect, and the study baseline Mean Rating on Morning Sleepiness as a covariate. Missing values are not imputed and assumed to be MAR.||0.353|0.057|0.0067
72367190|NCT02952820|144245021|SUPERIORITY||LSM Difference|0.171|STANDARD_ERROR_OF_MEAN|0.076||0.0237|TWO_SIDED|95.0|0.023|0.32|||Mixed Models Analysis|||First 7 nights (Statistical analysis 2): Based on MMRM model with factors of age group, region, treatment, visit (First 7 nights), and treatment-by-visit interaction as fixed effect, and the study baseline Mean Rating on Morning Sleepiness as a covariate. Missing values are not imputed and assumed to be MAR.||0.320|0.023|0.0237
72367191|NCT02952820|144245021|SUPERIORITY||LSM Difference|0.077|STANDARD_ERROR_OF_MEAN|0.094||0.412|TWO_SIDED|95.0|-0.107|0.261|||Mixed Models Analysis|||Month 1 (Statistical analysis 3): Based on MMRM model with factors of age group, region, treatment, visit (Month 1), and treatment-by-visit interaction as fixed effect, and the study baseline Mean Rating on Morning Sleepiness as a covariate. Missing values are not imputed and assumed to be MAR.||0.261|-0.107|0.4120
72367192|NCT02952820|144245021|SUPERIORITY||LSM Difference|0.073|STANDARD_ERROR_OF_MEAN|0.094||0.4347|TWO_SIDED|95.0|-0.111|0.258|||Mixed Models Analysis|||Month 1 (Statistical analysis 4): Based on MMRM model with factors of age group, region, treatment, visit (Month 1), and treatment-by-visit interaction as fixed effect, and the study baseline Mean Rating on Morning Sleepiness as a covariate. Missing values are not imputed and assumed to be MAR.||0.258|-0.111|0.4347
72367193|NCT02952820|144245021|SUPERIORITY||LSM Difference|0.074|STANDARD_ERROR_OF_MEAN|0.109||0.4992|TWO_SIDED|95.0|-0.141|0.289|||Mixed Models Analysis|||Month 3 (Statistical analysis 5): Based on MMRM model with factors of age group, region, treatment, visit (Month 3), and treatment-by-visit interaction as fixed effect, and the study baseline Mean Rating on Morning Sleepiness as a covariate. Missing values are not imputed and assumed to be MAR.||0.289|-0.141|0.4992
72553281|NCT01077596|144637887|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|0.9||||||95.0|0.8|1.1|||||Adjusted for age, sex, cal year, study site, tumor characteristics, multiple antidepressants exposure, smoking, hysterectomy status, previous depression dx, previous IBD diagnosis, OC use, HRT/ERT use, and NSAID use.|||1.1|0.8|
72367194|NCT02952820|144245021|SUPERIORITY||LSM Difference|0.255|STANDARD_ERROR_OF_MEAN|0.11||0.0208|TWO_SIDED|95.0|0.039|0.471|||Mixed Models Analysis|||Month 3 (Statistical analysis 6): Based on MMRM model with factors of age group, region, treatment, visit (Month 3), and treatment-by-visit interaction as fixed effect, and the study baseline Mean Rating on Morning Sleepiness as a covariate. Missing values are not imputed and assumed to be MAR.||0.471|0.039|0.0208
72367195|NCT02952820|144245021|SUPERIORITY||LSM Difference|0.144|STANDARD_ERROR_OF_MEAN|0.119||0.2248|TWO_SIDED|95.0|-0.089|0.378|||Mixed Models Analysis|||Month 6 (Statistical analysis 7): Based on MMRM model with factors of age group, region, treatment, visit (Month 6), and treatment-by-visit interaction as fixed effect, and the study baseline Mean Rating on Morning Sleepiness as a covariate. Missing values are not imputed and assumed to be MAR.||0.378|-0.089|0.2248
72367196|NCT02952820|144245021|SUPERIORITY||LSM Difference|0.261|STANDARD_ERROR_OF_MEAN|0.12||0.0298|TWO_SIDED|95.0|0.026|0.497|||Mixed Models Analysis|||Month 6 (Statistical analysis 8): Based on MMRM model with factors of age group, region, treatment, visit (Month 6), and treatment-by-visit interaction as fixed effect, and the study baseline Mean Rating on Morning Sleepiness as a covariate. Missing values are not imputed and assumed to be MAR.||0.497|0.026|0.0298
72367197|NCT03486834|144245037|OTHER|The incidence rate per 100 person years (100 x number of CMVi cases/total person-years to CMVi or end of follow-up) is presented along with 95% confidence interval (CI).|Incidence Rate Estimate|2.9|||||TWO_SIDED|95.0|1.6|4.9||||||||4.9|1.6|
72367198|NCT03486834|144245037|OTHER|The incidence rate per 100 person years (100 x number of CMVi cases/total person-years to CMVi or end of follow-up) is presented along with 95% CI.|Incidence Rate Estimate|5.1|||||TWO_SIDED|95.0|3.3|7.6||||||||7.6|3.3|
72367199|NCT03486834|144245037|OTHER|The statistical criterion for success requires the lower limit of the 95% CI of vaccine efficacy (VE) to be greater than 0%.|Vaccine Efficacy|42.4|||||TWO_SIDED|95.0|-13.5|71.1||||||||71.1|-13.5|
72367200|NCT03486834|144245038|OTHER||Difference in Percent|59.8|||||TWO_SIDED|95.0|55.8|63.5||||||||63.5|55.8|
72367201|NCT03486834|144245038|OTHER||Difference in Percent|57.6|||||TWO_SIDED|95.0|53.5|61.5||||||||61.5|53.5|
72367202|NCT03486834|144245039|OTHER||Difference in Percent|15.9|||||TWO_SIDED|95.0|11.7|20.1||||||||20.1|11.7|
72367203|NCT03486834|144245039|OTHER||Difference in Percent|17.4|||||TWO_SIDED|95.0|13.3|21.6||||||||21.6|13.3|
72367204|NCT03486834|144245040|OTHER||Difference in Percent|0.0|||||TWO_SIDED|95.0|-0.5|0.5||||||||0.5|-0.5|
72367205|NCT03486834|144245040|OTHER||Difference in Percent|0.0|||||TWO_SIDED|95.0|-0.5|0.5||||||||0.5|-0.5|
72367206|NCT03486834|144245041|OTHER|The incidence rate per 100 person years (100 x number of CMVi cases/total person-years to CMVi or end of follow-up) is presented along with 95% CI.|Incidence Rate Estimate|6.7|||||TWO_SIDED|95.0|4.6|9.5||||||||9.5|4.6|
72367207|NCT03486834|144245041|OTHER|The incidence rate per 100 person years (100 x number of CMVi cases/total person-years to CMVi or end of follow-up) is presented along with 95% CI.|Incidence Rate Estimate|5.1|||||TWO_SIDED|95.0|3.3|7.6||||||||7.6|3.3|
72367208|NCT03486834|144245041|OTHER|The statistical criterion for success requires the lower limit of the 95% CI of vaccine efficacy (VE) to be greater than 0%.|Vaccine Efficacy|-32.0|||||TWO_SIDED|95.0|-135.0|25.0||||||||25.0|-135.0|
72367209|NCT00638014|144245063|SUPERIORITY_OR_OTHER|||||||0.41||95.0|||||t-test, 2 sided|||||||0.41
72367210|NCT01587924|144245075|SUPERIORITY_OR_OTHER|||||||0.0135||95.0||||The p-value is showing the interaction of each subgroup by treatment and by day|Regression, Linear|||Modeled Hgb change from baseline in participants with Baseline Hgb \<10.80 versus modeled Hgb change from baseline in participants with Baseline Hgb \>= 10.80||||0.0135
72367211|NCT01587924|144245075|SUPERIORITY_OR_OTHER|||||||0.5082||95.0||||The p-value is showing the interaction of each subgroup by treatment and by day|Regression, Linear|||Modeled Hgb change from baseline in participants with Baseline weight \<= 80.5 Kg versus modeled Hgb change from baseline in participants with Baseline weight \> 80.5||||0.5082
72367212|NCT01587924|144245075|SUPERIORITY_OR_OTHER|||||||0.977||95.0||||The p-value is showing the interaction of each subgroup by treatment and by day|Regression, Linear|||Modeled Hgb change from baseline in participants with ethnicity non-Hispanic or Latino versus modeled Hgb change from baseline in participants with ethnicity non-Hispanic or Latino||||0.9770
72367213|NCT01587924|144245075|SUPERIORITY_OR_OTHER|||||||0.0618||95.0||||The p-value is showing the interaction of each subgroup by treatment and by day|Regression, Linear|||Modeled Hgb change from baseline in participants with Baseline geographic ancestry as African American versus modeled Hgb change from baseline in participants with no geographic ancestry as African American||||0.0618
72367214|NCT01587924|144245075|SUPERIORITY_OR_OTHER|||||||0.7495||95.0||||The p-value is showing the interaction of each subgroup by treatment and by day|Regression, Linear|||Modeled Hgb change from baseline in participants with Baseline gender as male versus modeled Hgb change from baseline in participants with Baseline gender female||||0.7495
72367215|NCT01587924|144245075|SUPERIORITY_OR_OTHER|||||||0.7865||95.0||||The p-value is showing the interaction of each subgroup by treatment and by day|Regression, Linear|||Modeled Hgb change from baseline in participants with Baseline age \<65 years versus modeled Hgb change from baseline in participants with Baseline age \>=65 years||||0.7865
72367216|NCT01587924|144245075|SUPERIORITY_OR_OTHER|||||||0.0622||95.0||||The p-value is showing the interaction of each subgroup by treatment and by day|Regression, Linear|||Modeled Hgb change from baseline in participants with Baseline co-ad with food versus modeled Hgb change from baseline in participants with Baseline co-ad without food||||0.0622
72367217|NCT01587924|144245075|SUPERIORITY_OR_OTHER|||||||0.2044||95.0||||The p-value is showing the interaction of each subgroup by treatment and by day|Regression, Linear|||Modeled Hgb change from baseline in participants with Baseline diabetes presence versus modeled Hgb change from baseline in participants with no Baseline diabetes||||0.2044
72367218|NCT01587924|144245075|SUPERIORITY_OR_OTHER|||||||0.8537||95.0||||The p-value is showing the interaction of each subgroup by treatment and by day|Regression, Linear|||Modeled Hgb change from baseline in participants with Baseline region as the US and Canada versus modeled Hgb change from baseline in participants with Baseline region as not the US and Canada||||0.8537
72367219|NCT02379091|144245117|SUPERIORITY_OR_OTHER||Least Squares (LS) Mean Difference|-0.61|STANDARD_ERROR_OF_MEAN|0.351||0.086|TWO_SIDED|95.0|-1.31|0.09||MMRM model with main effects for study site, treatment, visit, and previously failed medication with interactions between visit and treatment, visit and previously failed medication, and visit and baseline value.|ANOVA|Baseline values were used as a covariate and participant as a random effect with an unstructured covariance structure.|Namilumab - Placebo|||0.09|-1.31|0.086
72367220|NCT02379091|144245117|SUPERIORITY_OR_OTHER||LS Mean|-0.6|STANDARD_ERROR_OF_MEAN|0.366||0.107|TWO_SIDED|95.0|-1.32|0.13||MMRM model with main effects for study site, treatment, visit, and previously failed medication with interactions between visit and treatment, visit and previously failed medication, and visit and baseline value.|ANOVA|Baseline values were used as a covariate and subject as a random effect with an unstructured covariance structure.|Namilumab - Placebo|||0.13|-1.32|0.107
72367221|NCT02379091|144245117|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.92|STANDARD_ERROR_OF_MEAN|0.347||0.01|TWO_SIDED|95.0|-1.61|-0.23||MMRM model with main effects for study site, treatment, visit, and previously failed medication with interactions between visit and treatment, visit and previously failed medication, and visit and baseline value.|ANOVA|Baseline values were used as a covariate and subject as a random effect with an unstructured covariance structure.|Namilumab - Placebo|||-0.23|-1.61|0.010
72367222|NCT02129699|144245128|SUPERIORITY|Pre-specified analysis|Hazard Ratio (HR)|0.96||||0.355|TWO_SIDED|95.0|0.78|1.19|||Regression, Cox|Cox regression model for treatment effect, analysis adjusted for stratification factors||||1.19|0.78|0.355
72367223|NCT02129699|144245129|SUPERIORITY|Pre-specified analysis|Hazard Ratio (HR)|0.99||||0.459|TWO_SIDED|95.0|0.82|1.19|||Regression, Cox|||||1.19|0.82|0.459
72367224|NCT00630838|144245143|SUPERIORITY_OR_OTHER||||||=|0.897|TWO_SIDED||||||t-test, 2 sided|||||||=0.897
72367225|NCT01424072|144245152|SUPERIORITY_OR_OTHER|||||||0.023||95.0||||It was verified the normality of data distribution and the homogeneity of variance.|ANOVA|||The main objective was to compare the difference among the control group, seeds and needles and to recognize significant outcomes of auriculotherapy by seeds or needles.||||0.023
72367226|NCT01424072|144245153|SUPERIORITY_OR_OTHER||||||,|0||95.0||||It was verified the normality of data distribution and the homogeneity of variance.|ANOVA|This result was only to the domain Social Support.||It was carried out the analysis of variance (ANOVA) among the groups in the 3rd assessment (after 60 days) and at the follow up (after 75 days). The main objective was to compare the difference among the control group, seeds and needles and to recognize significant outcomes of auriculotherapy by seeds or needles.||||0,022
72367227|NCT01424072|144245154|SUPERIORITY_OR_OTHER|||||||0.039||95.0||||It was verified the normality of data distribution and the homogeneity of variance.|ANOVA|||It was carried out the analysis of variance (ANOVA) among the groups at the follow up (after 75 days). The main objective was to compare the difference among the control group, seeds and needles and to recognize significant outcomes of auriculotherapy by seeds or needles.||||0.039
72367228|NCT01424072|144245154|SUPERIORITY_OR_OTHER|||||||0.029||95.0|||||ANOVA|It was carried out the analysis of variance (ANOVA) among the groups at the follow up and then it was used the post hoc test.||Coping Strategy: Confrontation domain||||0.029
72367229|NCT01646125|144245184|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.76|||||TWO_SIDED|90.0|0.35|1.63||||||||1.63|0.35|
72367230|NCT00904033|144245209|OTHER|||||||0.86|||||||ANCOVA|Main Effects Results only for No Exercise vs Exercise||||||0.86
72367231|NCT00904033|144245210|OTHER|||||||0.19|||||||ANCOVA|||||||0.19
72367232|NCT00904033|144245211|OTHER|||||||0.49|||||||ANCOVA|||||||0.49
72367233|NCT00904033|144245212|OTHER||||||<|0.01|||||||ANCOVA|||||||<0.01
72367234|NCT00904033|144245213|OTHER|||||||0.16|||||||t-test, 2 sided|||||||0.16
72367235|NCT00904033|144245214|OTHER|||||||0.84|||||||t-test, 2 sided|||||||0.84
72367236|NCT00904033|144245215|OTHER|||||||0.38|||||||t-test, 2 sided|||||||0.38
72367237|NCT00904033|144245216|OTHER|||||||0.92|||||||t-test, 2 sided|||||||0.92
72367238|NCT01357850|144245217|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0119||||0.7873|TWO_SIDED|95.0|-0.0768|0.1005|||ANOVA|||||0.1005|-0.0768|0.7873
72367239|NCT01357850|144245217|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0678||||0.0499|TWO_SIDED|95.0|0.0|0.1356|||ANOVA|||||0.1356|0.0000|0.0499
72367240|NCT01357850|144245217|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0467||||0.1666|TWO_SIDED|95.0|-0.0204|0.1137|||ANOVA|||||0.1137|-0.0204|0.1666
72367241|NCT01357850|144245218|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|134.89||||0.9343|TWO_SIDED|95.0|-3172.05|3441.83|||ANOVA|||||3441.83|-3172.05|0.9343
72367242|NCT01357850|144245218|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1278.77||||0.3375|TWO_SIDED|95.0|-1398.13|3955.68|||ANOVA|||||3955.68|-1398.13|0.3375
72367243|NCT01357850|144245218|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|772.7||||0.5582|TWO_SIDED|95.0|-1887.77|3433.17|||ANOVA|||||3433.17|-1887.77|0.5582
72367244|NCT01357850|144245219|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-2.06||||0.2256|TWO_SIDED|95.0|-5.43|1.3|||ANOVA|||||1.30|-5.43|0.2256
72367245|NCT01357850|144245219|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.95||||0.5647|TWO_SIDED|95.0|-4.22|2.32|||ANOVA|||||2.32|-4.22|0.5647
72367246|NCT01357850|144245219|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.18||||0.8942|TWO_SIDED|95.0|-2.44|2.79|||ANOVA|||||2.79|-2.44|0.8942
72367247|NCT00118417|144245265|SUPERIORITY_OR_OTHER|||||||0||95.0||||Paired t-test between endpoint and baseline PDSS|t-test, 2 sided|Degrees of Freedom = 38||||||0.0000
72367248|NCT00118417|144245266|SUPERIORITY_OR_OTHER|||||||0.97||95.0||||T-test of PDSS change score|t-test, 2 sided|Degrees of Freedom = 22||||||0.97
72367249|NCT00118417|144245267|SUPERIORITY_OR_OTHER|||||||0.061||95.0||||T-test of PDSS change between baseline and endpoint of Phase 3|t-test, 2 sided|Degrees of Freedom = 17||||||0.061
72367250|NCT00785785|144245268|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.466||||0.0081|TWO_SIDED|95.0|1.104|1.945|||Hazard Ratio|||||1.945|1.104|0.0081
72367251|NCT01383356|144245269|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence|Geometric mean ratio (GMR) in percent|118.0|||||TWO_SIDED|90.0|111.0|125.0|||||Lina/Met 2.5mg/500mg versus (vs.) Lina 2.5mg plus Met 500mg.|The two formulations are shown to be bioequivalent if the geometric mean ratio is contained within the 80 to 125 percent range both on measured data (statistical analysis 1) and on potency corrected data (percent potency of label claim) (statistical analysis 2). ANOVA was applied to log-transformed Cmax and included study, subject-within-study, period-within-study, treatment and study-by-treatment interaction.||125|111|
72367252|NCT01383356|144245269|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence|GMR, potency corrected (percent)|122.0|||||TWO_SIDED|90.0|114.0|130.0|||||Lina/Met 2.5mg/500mg vs. Lina 2.5mg plus Met 500mg.|ANOVA was applied to log-transformed Cmax and included study, subject-within-study, period-within-study, treatment and study-by-treatment interaction. Results were potency corrected (GMR multiplied by the quotient of drug potency (DP) of Met in single tablet and DP of Met in combination tablet).||130|114|
72553282|NCT01077596|144637887|SUPERIORITY_OR_OTHER||Crude Odds Ratio|1.0||||||95.0|0.9|1.2||||||||1.2|0.9|
72367253|NCT01383356|144245270|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence|Geometric mean ratio (percent)|105.0||||||90.0|101.0|108.0|||||Lina/Met 2.5mg/500mg vs. Lina 2.5mg plus Met 500mg.|The two formulations are shown to be bioequivalent if the 90 percent confidence interval of geometric mean ratio is entirely contained within the 80 to125 percent range both on measured data (statistical analysis 1) and potency corrected data (percent potency of label claim) (statistical analysis 2). ANOVA was applied to log-transformed AUC0-t and included study, subject-within-study, period-within-study, treatment and study-by-treatment interaction.||108|101|
72367254|NCT01383356|144245270|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence|GMR, potency corrected (percent)|108.0||||||90.0|105.0|112.0|||||Lina/Met 2.5mg/500mg vs.Lina 2.5mg plus Met 500mg.|ANOVA was applied to log-transformed AUC0-t and included study, subject-within-study, period-within-study, treatment and study-by-treatment interaction. Results were potency corrected (GMR multiplied by the quotient of DP of Met in single tablet and DP of Met in combination tablet).||112|105|
72367255|NCT01383356|144245271|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence (BE), AUC0-inf was no BE criteria|Geometric mean ratio (percent)|105.0||||||90.0|101.0|108.0|||||Lina/Met 2.5mg/500mg vs. Lina 2.5mg plus Met 500mg.|ANOVA was applied to log-transformed AUC0-inf and included study, subject-within-study, period-within-study, treatment and study-by-treatment interaction.||108|101|
72367256|NCT01383356|144245271|NON_INFERIORITY_OR_EQUIVALENCE|BE, AUC0-inf was no BE criteria|GMR, potency corrected (percent)|108.0||||||90.0|105.0|112.0|||||Lina/Met 2.5mg/500mg vs. Lina 2.5mg plus Met 500mg.|ANOVA was applied to log-transformed AUC0-inf and included study, subject-within-study, period-within-study, treatment and study-by-treatment interaction. Results were potency corrected (GMR multiplied by the quotient of DP of Met in single tablet and DP of Met in combination tablet).||112|105|
72367257|NCT03219528|144245272|SUPERIORITY|||||||0.78|||||||Mixed Models Analysis|||Baseline||||0.78
72367258|NCT03219528|144245272|SUPERIORITY|||||||0.88|||||||Mixed Models Analysis|||Week 5||||0.88
72367259|NCT03219528|144245281|SUPERIORITY|||||||0.77|||||||Mixed Models Analysis|||Baseline||||0.77
72367260|NCT03219528|144245281|SUPERIORITY|||||||0.58|||||||Mixed Models Analysis|||Week 5||||0.58
72367261|NCT01532986|144245283|SUPERIORITY||Mean Difference (Final Values)|0.189|||>|0.05|TWO_SIDED|95.0|0.157|0.222|||t-test, 2 sided|||||0.222|0.157|>0.05
72367262|NCT01532986|144245284|SUPERIORITY||Mean Difference (Final Values)|0.02|||>|0.05|TWO_SIDED|95.0|-0.04|0.08|||t-test, 2 sided|||||0.08|-0.04|>0.05
72367263|NCT01532986|144245285|SUPERIORITY||Mean Difference (Final Values)|0.02|||>|0.05|TWO_SIDED|95.0|-0.52|0.57|||t-test, 2 sided|||||0.57|-0.52|>0.05
72367264|NCT01532986|144245286|SUPERIORITY||Mean Difference (Final Values)|-0.12|||>|0.05|TWO_SIDED|95.0|-0.34|0.1|||t-test, 2 sided|||||0.10|-0.34|>0.05
72367265|NCT01532986|144245287|SUPERIORITY||Mean Difference (Final Values)|-0.88|||>|0.05|TWO_SIDED|95.0|-2.04|0.29|||t-test, 2 sided|||||0.29|-2.04|>0.05
72367266|NCT01532986|144245288|SUPERIORITY||Mean Difference (Final Values)|1.22|||>|0.05|TWO_SIDED|95.0|-8.02|10.46|||t-test, 2 sided|||||10.46|-8.02|>0.05
72367267|NCT01532986|144245289|SUPERIORITY||Mean Difference (Final Values)|0.17|||>|0.05|TWO_SIDED|95.0|0.0|0.34|||t-test, 2 sided|||||0.34|0.00|>0.05
72367268|NCT01532986|144245290|SUPERIORITY||Mean Difference (Final Values)|-0.06|||>|0.05|TWO_SIDED|95.0|-1.45|1.33|||t-test, 2 sided|||||1.33|-1.45|>0.05
72367269|NCT01532986|144245291|SUPERIORITY||Mean Difference (Final Values)|-11.52|||<|0.05|TWO_SIDED|95.0|-20.42|-2.62|||t-test, 2 sided|||||-2.62|-20.42|<0.05
72367270|NCT01532986|144245292|SUPERIORITY||Mean Difference (Final Values)|-1.98|||>|0.05|TWO_SIDED|95.0|-4.2|0.24|||t-test, 2 sided|||||0.24|-4.20|>0.05
72367271|NCT02120898|144245293|EQUIVALENCE|90% CI interval was -0.20 to +0.20 for therapeutic equivalence.|Percentage difference|-1.16||||0.0702|TWO_SIDED|90.0|-7.93|5.62|||Fisher Exact|||Analysis was performed using 90% Wald's confidence interval (CI) with a continuity correction or the difference (generic imiquimod - Zyclara) in complete clearance rates.||5.62|-7.93|0.0702
72367272|NCT02120898|144245294|SUPERIORITY||Percentage difference|0.14||||0.0318|TWO_SIDED|90.0|-6.08|6.35||Threshold for significance at 0.05 level.|Fisher Exact|||Analysis was performed using 90% Wald's CI with a continuity correction or the difference (generic imiquimod - Zyclara) in complete clearance rates.||6.35|-6.08|0.0318
72367273|NCT00043979|144245309|SUPERIORITY_OR_OTHER|||||||0.0003||||||7 participants who did not receive a transplant compared with 21 participants transplanted.|Kaplan-Meier|||||||.0003
72367274|NCT04614974|144245316|SUPERIORITY|||||||0.3|||||||Wilcoxon (Mann-Whitney)|||||||0.3
72367275|NCT04614974|144245317|SUPERIORITY|||||||0.8|||||||Wilcoxon (Mann-Whitney)|||||||0.8
72367276|NCT04614974|144245318|OTHER|||||||0.5|||||||McNemar|||Noisy breathing pre/post||||0.5
72367277|NCT04614974|144245318|OTHER|||||||0.01|||||||McNemar|||Noisy breathing pre/post||||0.01
72367278|NCT04614974|144245318|OTHER|||||||0.2|||||||McNemar|||Stridor pre/post||||0.2
72367279|NCT04614974|144245318|SUPERIORITY|||||||0.02|||||||McNemar|||Stridor pre/post||||0.02
72367280|NCT04614974|144245318|OTHER|||||||0.5|||||||McNemar|||Chest wall retractions pre/post||||0.5
72367281|NCT04614974|144245318|OTHER|||||||1|||||||McNemar|||Chest wall retractions pre/post||||1.0
72367282|NCT04614974|144245318|OTHER|||||||1|||||||McNemar|||Apnea pre/post||||1.0
72367283|NCT04614974|144245319|OTHER|||||||0.5|||||||McNemar|||Emesis pre/post||||0.5
72367284|NCT04614974|144245319|OTHER|||||||0.07|||||||McNemar|||Emesis pre/post||||0.07
72367285|NCT04614974|144245319|SUPERIORITY|||||||0.06|||||||McNemar|||Choking pre/post||||0.06
72367286|NCT04614974|144245319|OTHER|||||||1|||||||McNemar|||Choking pre/post||||1.0
72367287|NCT04614974|144245319|OTHER|||||||0.02|||||||McNemar|||Coughing pre/post||||0.02
72367288|NCT04614974|144245319|OTHER|||||||1|||||||Wilcoxon (Mann-Whitney)|||Coughing pre/post||||1.0
72367289|NCT04614974|144245319|OTHER|||||||1|||||||McNemar|||Gagging pre/post||||1.0
72367290|NCT04614974|144245320|SUPERIORITY|||||||0.3|||||||Wilcoxon (Mann-Whitney)|||||||0.3
72367291|NCT04614974|144245321|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.0
72367292|NCT00658359|144245328|SUPERIORITY_OR_OTHER||Estimated rate difference|2.19|STANDARD_ERROR_OF_MEAN|5.12||0.6694|TWO_SIDED|60.0|-2.12|6.5|||Wald Test||Tofacitinib LI minus CsA. Standard error of the mean refers to standard error of the estimated rate difference|Month 15||6.50|-2.12|0.6694
72367293|NCT00658359|144245328|SUPERIORITY_OR_OTHER||Estimated rate difference|10.71|STANDARD_ERROR_OF_MEAN|6.26||0.0873|TWO_SIDED|60.0|5.44|15.98|||Wald Test||Tofacitinib MI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 15||15.98|5.44|0.0873
72367294|NCT00658359|144245328|SUPERIORITY_OR_OTHER||Estimated rate difference|3.93|STANDARD_ERROR_OF_MEAN|5.71||0.4912|TWO_SIDED|60.0|-0.87|8.74|||Wald Test||Tofacitinib LI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 18||8.74|-0.87|0.4912
72367295|NCT00658359|144245328|SUPERIORITY_OR_OTHER||Estimated rate difference|11.06|STANDARD_ERROR_OF_MEAN|6.61||0.0942|TWO_SIDED|60.0|5.5|16.62|||Wald Test||Tofacitinib MI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 18||16.62|5.50|0.0942
72367296|NCT00658359|144245328|SUPERIORITY_OR_OTHER||Estimated rate difference|7.31|STANDARD_ERROR_OF_MEAN|6.36||0.2499|TWO_SIDED|60.0|1.96|12.66|||Wald Test||Tofacitinib LI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 24||12.66|1.96|0.2499
72367297|NCT00658359|144245328|SUPERIORITY_OR_OTHER||Estimated rate difference|13.47|STANDARD_ERROR_OF_MEAN|7.1||0.058|TWO_SIDED|60.0|7.49|19.45|||Wald Test||Tofacitinib MI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 24||19.45|7.49|0.0580
72367298|NCT00658359|144245328|SUPERIORITY_OR_OTHER||Estimated rate difference|12.62|STANDARD_ERROR_OF_MEAN|7.09||0.075|TWO_SIDED|60.0|6.66|18.59|||Wald Test||Tofacitinib LI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 30||18.59|6.66|0.0750
72367299|NCT00658359|144245328|SUPERIORITY_OR_OTHER||Estimated rate difference|16.66|STANDARD_ERROR_OF_MEAN|7.75||0.0316|TWO_SIDED|60.0|10.14|23.19|||Wald Test||Tofacitinib MI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 30||23.19|10.14|0.0316
72367300|NCT00658359|144245328|SUPERIORITY_OR_OTHER||Estimated rate difference|13.21|STANDARD_ERROR_OF_MEAN|7.5||0.0783|TWO_SIDED|60.0|6.9|19.53|||Wald Test||Tofacitinib LI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 36||19.53|6.90|0.0783
72367301|NCT00658359|144245328|SUPERIORITY_OR_OTHER||Estimated rate difference|20.27|STANDARD_ERROR_OF_MEAN|9.14||0.0266|TWO_SIDED|60.0|12.58|27.96|||Wald Test||Tofacitinib MI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 36||27.96|12.58|0.0266
72367302|NCT00658359|144245328|SUPERIORITY_OR_OTHER||Estimated rate difference|13.21|STANDARD_ERROR_OF_MEAN|7.5||0.0783|TWO_SIDED|60.0|6.9|19.53|||Wald Test||Tofacitinib LI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 42||19.53|6.90|0.0783
72367303|NCT00658359|144245328|SUPERIORITY_OR_OTHER||Estimated rate difference|20.27|STANDARD_ERROR_OF_MEAN|9.14||0.0266|TWO_SIDED|60.0|12.58|27.96|||Wald Test||Tofacitinib MI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 42||27.96|12.58|0.0266
72367304|NCT00658359|144245328|SUPERIORITY_OR_OTHER||Estimated rate difference|11.02|STANDARD_ERROR_OF_MEAN|7.74||0.1545|TWO_SIDED|60.0|4.51|17.54|||Wald Test||Tofacitinib LI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 48||17.54|4.51|0.1545
72367305|NCT00658359|144245328|SUPERIORITY_OR_OTHER||Estimated rate difference|18.08|STANDARD_ERROR_OF_MEAN|9.34||0.0528|TWO_SIDED|60.0|10.22|25.94|||Wald Test||Tofacitinib MI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 48||25.94|10.22|0.0528
72367306|NCT00658359|144245328|SUPERIORITY_OR_OTHER||Estimated rate difference|14.03|STANDARD_ERROR_OF_MEAN|8.45||0.0968|TWO_SIDED|60.0|6.92|21.14|||Wald Test||Tofacitinib LI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 54||21.14|6.92|0.0968
72367307|NCT00658359|144245328|SUPERIORITY_OR_OTHER||Estimated rate difference|15.83|STANDARD_ERROR_OF_MEAN|9.53||0.0966|TWO_SIDED|60.0|7.81|23.85|||Wald Test||Tofacitinib MI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 54||23.85|7.81|0.0966
72367308|NCT00658359|144245328|SUPERIORITY_OR_OTHER||Estimated rate difference|17.07|STANDARD_ERROR_OF_MEAN|8.74||0.0507|TWO_SIDED|60.0|9.72|24.42|||Wald Test||Tofacitinib LI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 60||24.42|9.72|0.0507
72367309|NCT00658359|144245328|SUPERIORITY_OR_OTHER||Estimated rate difference|15.83|STANDARD_ERROR_OF_MEAN|9.53||0.0966|TWO_SIDED|60.0|7.81|23.85|||Wald Test||Tofacitinib MI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 60||23.85|7.81|0.0966
72367310|NCT00658359|144245328|SUPERIORITY_OR_OTHER||Estimated rate difference|17.07|STANDARD_ERROR_OF_MEAN|8.74||0.0507|TWO_SIDED|60.0|9.72|24.42|||Wald Test||Tofacitinib LI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 66||24.42|9.72|0.0507
72367311|NCT00658359|144245328|SUPERIORITY_OR_OTHER||Estimated rate difference|15.83|STANDARD_ERROR_OF_MEAN|9.53||0.0966|TWO_SIDED|60.0|7.81|23.85|||Wald Test||Tofacitinib MI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 66||23.85|7.81|0.0966
72367312|NCT00658359|144245328|SUPERIORITY_OR_OTHER||Estimated rate difference|18.17|STANDARD_ERROR_OF_MEAN|9.56||0.0574|TWO_SIDED|60.0|10.12|26.22|||Wald Test||Tofacitinib LI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 72||26.22|10.12|0.0574
72367313|NCT00658359|144245328|SUPERIORITY_OR_OTHER||Estimated rate difference|21.08|STANDARD_ERROR_OF_MEAN|11.84||0.0749|TWO_SIDED|60.0|11.12|31.04|||Wald Test||Tofacitinib MI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 72||31.04|11.12|0.0749
72367314|NCT00658359|144245328|SUPERIORITY_OR_OTHER||Estimated rate difference|3.65|STANDARD_ERROR_OF_MEAN|4.44||0.4116|TWO_SIDED|60.0|-0.09|7.38|||Wald Test||Tofacitinib LI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 12||7.38|-0.09|0.4116
72367315|NCT00658359|144245328|SUPERIORITY_OR_OTHER||Estimated rate difference|-0.98|STANDARD_ERROR_OF_MEAN|3.69||0.7895|TWO_SIDED|60.0|-4.09|2.12|||Wald Test||Tofacitinib MI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 12||2.12|-4.09|0.7895
72367316|NCT00658359|144245329|SUPERIORITY_OR_OTHER||Estimated rate difference|2.4|STANDARD_ERROR_OF_MEAN|5.9||0.683|TWO_SIDED|95.0|-9.1|13.9|||Chi-squared||Tofacitinib LI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|||13.9|-9.1|0.683
72367317|NCT00658359|144245329|SUPERIORITY_OR_OTHER||Estimated rate difference|3.9|STANDARD_ERROR_OF_MEAN|6.2||0.529|TWO_SIDED|95.0|-8.3|16.1|||Chi-squared||Tofacitinib MI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|||16.1|-8.3|0.529
72367318|NCT00658359|144245330|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.23|STANDARD_ERROR_OF_MEAN|5.04||0.0699|TWO_SIDED|60.0|4.97|13.49|||Mixed Models Analysis||Tofacitinib LI minus CsA|||13.49|4.97|0.0699
72367319|NCT00658359|144245330|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.23|STANDARD_ERROR_OF_MEAN|6.32||0.1958|TWO_SIDED|60.0|2.89|13.58|||Mixed Models Analysis||Tofacitinib MI minus CsA|||13.58|2.89|0.1958
72367320|NCT00658359|144245332|SUPERIORITY_OR_OTHER||Estimated rate difference|2.19|STANDARD_ERROR_OF_MEAN|5.12||0.6694|TWO_SIDED|60.0|-2.12|6.5|||Wald Test||Tofacitinib LI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 15||6.50|-2.12|0.6694
72367321|NCT00658359|144245332|SUPERIORITY_OR_OTHER||Estimated rate difference|-0.41|STANDARD_ERROR_OF_MEAN|4.89||0.934|TWO_SIDED|60.0|-4.52|3.71|||Wald Test||Tofacitinib MI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 15||3.71|-4.52|0.9340
72367322|NCT00658359|144245332|SUPERIORITY_OR_OTHER||Estimated rate difference|0.6|STANDARD_ERROR_OF_MEAN|5.32||0.9106|TWO_SIDED|60.0|-3.88|5.08|||Wald Test||Tofacitinib LI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 18||5.08|-3.88|0.9106
72367323|NCT00658359|144245332|SUPERIORITY_OR_OTHER||Estimated rate difference|-1.99|STANDARD_ERROR_OF_MEAN|5.1||0.696|TWO_SIDED|60.0|-6.29|2.3|||Wald Test||Tofacitinib MI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 18||2.30|-6.29|0.6960
72367324|NCT00658359|144245332|SUPERIORITY_OR_OTHER||Estimated rate difference|0.6|STANDARD_ERROR_OF_MEAN|5.32||0.9106|TWO_SIDED|60.0|-3.88|5.08|||Wald Test||Tofacitinib LI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 24||5.08|-3.88|0.9106
72367325|NCT00658359|144245332|SUPERIORITY_OR_OTHER||Estimated rate difference|-1.99|STANDARD_ERROR_OF_MEAN|5.1||0.696|TWO_SIDED|60.0|-6.29|2.3|||Wald Test||Tofacitinib MI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 24||2.30|-6.29|0.6960
72367326|NCT00658359|144245332|SUPERIORITY_OR_OTHER||Estimated rate difference|0.6|STANDARD_ERROR_OF_MEAN|5.32||0.9106|TWO_SIDED|60.0|-3.88|5.08|||Wald Test||Tofacitinib LI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 30||5.08|-3.88|0.9106
72367327|NCT00658359|144245332|SUPERIORITY_OR_OTHER||Estimated rate difference|-1.99|STANDARD_ERROR_OF_MEAN|5.1||0.696|TWO_SIDED|60.0|-6.29|2.3|||Wald Test||Tofacitinib MI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 30||2.30|-6.29|0.6960
72367328|NCT00658359|144245332|SUPERIORITY_OR_OTHER||Estimated rate difference|-1.18|STANDARD_ERROR_OF_MEAN|5.56||0.8322|TWO_SIDED|60.0|-5.86|3.5|||Wald Test||Tofacitinib LI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 36||3.50|-5.86|0.8322
72367329|NCT00658359|144245332|SUPERIORITY_OR_OTHER||Estimated rate difference|-3.77|STANDARD_ERROR_OF_MEAN|5.35||0.4809|TWO_SIDED|60.0|-8.27|0.73|||Wald Test||Tofacitinib MI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 36||0.73|-8.27|0.4809
72367330|NCT00658359|144245332|SUPERIORITY_OR_OTHER||Estimated rate difference|-3.34|STANDARD_ERROR_OF_MEAN|5.89||0.5704|TWO_SIDED|60.0|-8.31|1.62|||Wald Test||Tofacitinib LI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 42||1.62|-8.31|0.5704
72367331|NCT00658359|144245332|SUPERIORITY_OR_OTHER||Estimated rate difference|-5.94|STANDARD_ERROR_OF_MEAN|5.7||0.2972|TWO_SIDED|60.0|-10.73|-1.14|||Wald Test||Tofacitinib MI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 42||-1.14|-10.73|0.2972
72367332|NCT00658359|144245332|SUPERIORITY_OR_OTHER||Estimated rate difference|-3.34|STANDARD_ERROR_OF_MEAN|5.89||0.5704|TWO_SIDED|60.0|-8.31|1.62|||Wald Test||Tofacitinib LI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 48||1.62|-8.31|0.5704
72367333|NCT00658359|144245332|SUPERIORITY_OR_OTHER||Estimated rate difference|-5.94|STANDARD_ERROR_OF_MEAN|5.7||0.2972|TWO_SIDED|60.0|-10.73|-1.14|||Wald Test||Tofacitinib MI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 48||-1.14|-10.73|0.2972
72367334|NCT00658359|144245332|SUPERIORITY_OR_OTHER||Estimated rate difference|-3.34|STANDARD_ERROR_OF_MEAN|5.89||0.5704|TWO_SIDED|60.0|-8.31|1.62|||Wald Test||Tofacitinib LI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 54||1.62|-8.31|0.5704
72367335|NCT00658359|144245332|SUPERIORITY_OR_OTHER||Estimated rate difference|-5.94|STANDARD_ERROR_OF_MEAN|5.7||0.2972|TWO_SIDED|60.0|-10.73|-1.14|||Wald Test||Tofacitinib MI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 54||-1.14|-10.73|0.2972
72367336|NCT00658359|144245332|SUPERIORITY_OR_OTHER||Estimated rate difference|-3.34|STANDARD_ERROR_OF_MEAN|5.89||0.5704|TWO_SIDED|60.0|-8.31|1.62|||Wald Test||Tofacitinib LI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 60||1.62|-8.31|0.5704
72367337|NCT00658359|144245332|SUPERIORITY_OR_OTHER||Estimated rate difference|-5.94|STANDARD_ERROR_OF_MEAN|5.7||0.2972|TWO_SIDED|60.0|-10.73|-1.14|||Wald Test||Tofacitinib MI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 60||-1.14|-10.73|0.2972
72367338|NCT00658359|144245332|SUPERIORITY_OR_OTHER||Estimated rate difference|-3.34|STANDARD_ERROR_OF_MEAN|5.89||0.5704|TWO_SIDED|60.0|-8.31|1.62|||Wald Test||Tofacitinib LI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 66||1.62|-8.31|0.5704
72367339|NCT00658359|144245332|SUPERIORITY_OR_OTHER||Estimated rate difference|-5.94|STANDARD_ERROR_OF_MEAN|5.7||0.2972|TWO_SIDED|60.0|-10.73|-1.14|||Wald Test||Tofacitinib MI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 66||-1.14|-10.73|0.2972
72367340|NCT00658359|144245332|SUPERIORITY_OR_OTHER||Estimated rate difference|-3.34|STANDARD_ERROR_OF_MEAN|5.89||0.5704|TWO_SIDED|60.0|-8.31|1.62|||Wald Test||Tofacitinib LI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 72||1.62|-8.31|0.5704
72367341|NCT00658359|144245332|SUPERIORITY_OR_OTHER||Estimated rate difference|-5.94|STANDARD_ERROR_OF_MEAN|5.7||0.2972|TWO_SIDED|60.0|-10.73|-1.14|||Wald Test||Tofacitinib MI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 72||-1.14|-10.73|0.2972
72367342|NCT00658359|144245332|SUPERIORITY_OR_OTHER||Estimated rate difference|3.75|STANDARD_ERROR_OF_MEAN|4.91||0.4455|TWO_SIDED|60.0|-0.39|7.89|||Wald Test||Tofacitinib LI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 12||7.89|-0.39|0.4455
72367343|NCT00658359|144245332|SUPERIORITY_OR_OTHER||Estimated rate difference|-0.69|STANDARD_ERROR_OF_MEAN|4.34||0.873|TWO_SIDED|60.0|-4.35|2.96|||Wald Test||Tofacitinib MI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 12||2.96|-4.35|0.8730
72367344|NCT00658359|144245333|SUPERIORITY_OR_OTHER||Estimated rate difference|-10.52|STANDARD_ERROR_OF_MEAN|5.71||0.0654|TWO_SIDED|60.0|-15.33|-5.71|||Wald Test||Tofacitinib LI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 15||-5.71|-15.33|0.0654
72367345|NCT00658359|144245333|SUPERIORITY_OR_OTHER||Estimated rate difference|-6.08|STANDARD_ERROR_OF_MEAN|6.37||0.3398|TWO_SIDED|60.0|-11.43|-0.72|||Wald Test||Tofacitinib MI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 15||-0.72|-11.43|0.3398
72367346|NCT00658359|144245333|SUPERIORITY_OR_OTHER||Estimated rate difference|-8.75|STANDARD_ERROR_OF_MEAN|6.23||0.1601|TWO_SIDED|60.0|-13.99|-3.51|||Wald Test||Tofacitinib LI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 18||-3.51|-13.99|0.1601
72367347|NCT00658359|144245333|SUPERIORITY_OR_OTHER||Estimated rate difference|-7.64|STANDARD_ERROR_OF_MEAN|6.49||0.239|TWO_SIDED|60.0|-13.1|-2.18|||Wald Test||Tofacitinib MI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 18||-2.18|-13.10|0.2390
72367348|NCT00658359|144245333|SUPERIORITY_OR_OTHER||Estimated rate difference|-7.08|STANDARD_ERROR_OF_MEAN|6.4||0.2685|TWO_SIDED|60.0|-12.47|-1.7|||Wald Test||Tofacitinib LI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 24||-1.70|-12.47|0.2685
72367349|NCT00658359|144245333|SUPERIORITY_OR_OTHER||Estimated rate difference|-7.64|STANDARD_ERROR_OF_MEAN|6.49||0.239|TWO_SIDED|60.0|-13.1|-2.18|||Wald Test||Tofacitinib MI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 24||-2.18|-13.10|0.2390
72367350|NCT00658359|144245333|SUPERIORITY_OR_OTHER||Estimated rate difference|-8.81|STANDARD_ERROR_OF_MEAN|6.55||0.1785|TWO_SIDED|60.0|-14.32|-3.3|||Wald Test||Tofacitinib LI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 30||-3.30|-14.32|0.1785
72367351|NCT00658359|144245333|SUPERIORITY_OR_OTHER||Estimated rate difference|-9.37|STANDARD_ERROR_OF_MEAN|6.63||0.158|TWO_SIDED|60.0|-14.95|-3.78|||Wald Test||Tofacitinib MI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 30||-3.78|-14.95|0.1580
72367352|NCT00658359|144245333|SUPERIORITY_OR_OTHER||Estimated rate difference|-12.27|STANDARD_ERROR_OF_MEAN|6.81||0.0718|TWO_SIDED|60.0|-18.0|-6.53|||Wald Test||Tofacitinib LI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 36||-6.53|-18.00|0.0718
72367353|NCT00658359|144245333|SUPERIORITY_OR_OTHER||Estimated rate difference|-12.83|STANDARD_ERROR_OF_MEAN|6.9||0.0629|TWO_SIDED|60.0|-18.63|-7.02|||Wald Test||Tofacitinib MI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 36||-7.02|-18.63|0.0629
72367354|NCT00658359|144245333|SUPERIORITY_OR_OTHER||Estimated rate differences|-15.89|STANDARD_ERROR_OF_MEAN|7.07||0.0246|TWO_SIDED|60.0|-21.84|-9.94|||Wald Test||Tofacitinib LI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 42||-9.94|-21.84|0.0246
72367355|NCT00658359|144245333|SUPERIORITY_OR_OTHER||Estimated rate difference|-16.45|STANDARD_ERROR_OF_MEAN|7.15||0.0214|TWO_SIDED|60.0|-22.46|-10.43|||Wald Test||Tofacitinib MI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 42||-10.43|-22.46|0.0214
72367356|NCT00658359|144245333|SUPERIORITY_OR_OTHER||Estimated rate difference|-15.89|STANDARD_ERROR_OF_MEAN|7.07||0.0246|TWO_SIDED|60.0|-21.84|-9.94|||Wald Test||Tofacitinib LI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 48||-9.94|-21.84|0.0246
72367357|NCT00658359|144245333|SUPERIORITY_OR_OTHER||Estimated rate difference|-16.45|STANDARD_ERROR_OF_MEAN|7.15||0.0214|TWO_SIDED|60.0|-22.46|-10.43|||Wald Test||Tofacitinib MI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 48||-10.43|-22.46|0.0214
72367358|NCT00658359|144245333|SUPERIORITY_OR_OTHER||Estimated rate difference|-18.02|STANDARD_ERROR_OF_MEAN|7.24||0.0128|TWO_SIDED|60.0|-24.12|-11.93|||Wald Test||Tofacitinib LI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 54||-11.93|-24.12|0.0128
72367359|NCT00658359|144245333|SUPERIORITY_OR_OTHER||Estimated rate difference|-18.58|STANDARD_ERROR_OF_MEAN|7.32||0.0111|TWO_SIDED|60.0|-24.74|-12.42|||Wald Test||Tofacitinib MI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 54||-12.42|-24.74|0.0111
72367360|NCT00658359|144245333|SUPERIORITY_OR_OTHER||Estimated rate difference|-18.02|STANDARD_ERROR_OF_MEAN|7.24||0.0128|TWO_SIDED|60.0|-24.12|-11.93|||Wald Test||Tofacitinib LI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 60||-11.93|-24.12|0.0128
72367361|NCT00658359|144245333|SUPERIORITY_OR_OTHER||Estimated rate difference|-18.58|STANDARD_ERROR_OF_MEAN|7.32||0.0111|TWO_SIDED|60.0|-24.74|-12.42|||Wald Test||Tofacitinib MI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 60||-12.42|-24.74|0.0111
72367362|NCT00658359|144245333|SUPERIORITY_OR_OTHER||Estimated rate difference|-18.02|STANDARD_ERROR_OF_MEAN|7.24||0.0128|TWO_SIDED|60.0|-24.12|-11.93|||Wald Test||Tofacitinib LI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 66||-11.93|-24.12|0.0128
72367363|NCT00658359|144245333|SUPERIORITY_OR_OTHER||Estimated rate difference|-18.58|STANDARD_ERROR_OF_MEAN|7.32||0.0111|TWO_SIDED|60.0|-24.74|-12.42|||Wald Test||Tofacitinib MI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 66||-12.42|-24.74|0.0111
72367364|NCT00658359|144245333|SUPERIORITY_OR_OTHER||Estimated rate difference|-18.02|STANDARD_ERROR_OF_MEAN|7.24||0.0128|TWO_SIDED|60.0|-24.12|-11.93|||Wald Test||Tofacitinib LI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 72||-11.93|-24.12|0.0128
72367365|NCT00658359|144245333|SUPERIORITY_OR_OTHER||Estimated rate difference|-18.58|STANDARD_ERROR_OF_MEAN|7.32||0.0111|TWO_SIDED|60.0|-24.74|-12.42|||Wald Test||Tofacitinib MI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 72||-12.42|-24.74|0.0111
72367366|NCT00658359|144245333|SUPERIORITY_OR_OTHER||Estimated rate difference|-7.4|STANDARD_ERROR_OF_MEAN|5.41||0.1715|TWO_SIDED|60.0|-11.95|-2.84|||Wald Test||Tofacitinib LI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 12||-2.84|-11.95|0.1715
72367367|NCT00658359|144245333|SUPERIORITY_OR_OTHER||Estimated rate difference|-4.8|STANDARD_ERROR_OF_MEAN|5.87||0.4131|TWO_SIDED|60.0|-9.74|0.14|||Wald Test||Tofacitinib MI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 12||0.14|-9.74|0.4131
72367368|NCT00658359|144245334|SUPERIORITY_OR_OTHER||Estimated rate difference|2.19|STANDARD_ERROR_OF_MEAN|5.12||0.6694|TWO_SIDED|60.0|-2.12|6.5|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 15||6.50|-2.12|0.6694
72367369|NCT00658359|144245334|SUPERIORITY_OR_OTHER||Estimated rate difference|1.45|STANDARD_ERROR_OF_MEAN|5.18||0.7799|TWO_SIDED|60.0|-2.91|5.8|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 15||5.80|-2.91|0.7799
72367370|NCT00658359|144245334|SUPERIORITY_OR_OTHER||Estimated rate difference|-0.99|STANDARD_ERROR_OF_MEAN|5.51||0.8572|TWO_SIDED|60.0|-5.63|3.65|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 18||3.65|-5.63|0.8572
72367371|NCT00658359|144245334|SUPERIORITY_OR_OTHER||Estimated rate difference|-1.73|STANDARD_ERROR_OF_MEAN|5.56||0.7555|TWO_SIDED|60.0|-6.41|2.95|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 18||2.95|-6.41|0.7555
72367372|NCT00658359|144245334|SUPERIORITY_OR_OTHER||Estimated rate difference|-0.99|STANDARD_ERROR_OF_MEAN|5.51||0.8572|TWO_SIDED|60.0|-5.63|3.65|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 24||3.65|-5.63|0.8572
72367373|NCT00658359|144245334|SUPERIORITY_OR_OTHER||Estimated rate difference|3.82|STANDARD_ERROR_OF_MEAN|6.22||0.539|TWO_SIDED|60.0|-1.41|9.06|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 24||9.06|-1.41|0.5390
72367374|NCT00658359|144245334|SUPERIORITY_OR_OTHER||Estimated rate difference|-2.64|STANDARD_ERROR_OF_MEAN|5.7||0.6432|TWO_SIDED|60.0|-7.44|2.16|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 30||2.16|-7.44|0.6432
72367375|NCT00658359|144245334|SUPERIORITY_OR_OTHER||Estimated rate difference|2.18|STANDARD_ERROR_OF_MEAN|6.39||0.7336|TWO_SIDED|60.0|-3.2|7.55|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 30||7.55|-3.20|0.7336
72367376|NCT00658359|144245334|SUPERIORITY_OR_OTHER||Estimated rate difference|-0.74|STANDARD_ERROR_OF_MEAN|6.57||0.9099|TWO_SIDED|60.0|-6.28|4.79|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 36||4.79|-6.28|0.9099
72367377|NCT00658359|144245334|SUPERIORITY_OR_OTHER||Estimated rate difference|0.77|STANDARD_ERROR_OF_MEAN|6.87||0.9106|TWO_SIDED|60.0|-5.01|6.56|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 36||6.56|-5.01|0.9106
72367378|NCT00658359|144245334|SUPERIORITY_OR_OTHER||Estimated rate difference|-4.4|STANDARD_ERROR_OF_MEAN|6.91||0.5244|TWO_SIDED|60.0|-10.22|1.42|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 42||1.42|-10.22|0.5244
72367379|NCT00658359|144245334|SUPERIORITY_OR_OTHER||Estimated rate difference|-0.9|STANDARD_ERROR_OF_MEAN|7.38||0.9029|TWO_SIDED|60.0|-7.11|5.31|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 42||5.31|-7.11|0.9029
72367380|NCT00658359|144245334|SUPERIORITY_OR_OTHER||Estimated rate difference|-2.58|STANDARD_ERROR_OF_MEAN|7.38||0.7267|TWO_SIDED|60.0|-8.78|3.63|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 48||3.63|-8.78|0.7267
72367381|NCT00658359|144245334|SUPERIORITY_OR_OTHER||Estimated rate difference|-2.73|STANDARD_ERROR_OF_MEAN|7.52||0.7168|TWO_SIDED|60.0|-9.06|3.6|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 48||3.60|-9.06|0.7168
72367382|NCT00658359|144245334|SUPERIORITY_OR_OTHER||Estimated rate difference|-4.4|STANDARD_ERROR_OF_MEAN|7.51||0.5574|TWO_SIDED|60.0|-10.72|1.91|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 54||1.91|-10.72|0.5574
72367383|NCT00658359|144245334|SUPERIORITY_OR_OTHER||Estimated rate difference|-4.56|STANDARD_ERROR_OF_MEAN|7.65||0.5515|TWO_SIDED|60.0|-10.99|1.88|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 54||1.88|-10.99|0.5515
72367384|NCT00658359|144245334|SUPERIORITY_OR_OTHER||Estimated rate difference|-4.4|STANDARD_ERROR_OF_MEAN|7.51||0.5574|TWO_SIDED|60.0|-10.72|1.91|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 60||1.91|-10.72|0.5574
72367385|NCT00658359|144245334|SUPERIORITY_OR_OTHER||Estimated rate difference|-2.3|STANDARD_ERROR_OF_MEAN|7.87||0.7704|TWO_SIDED|60.0|-8.92|4.33|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 60||4.33|-8.92|0.7704
72367386|NCT00658359|144245334|SUPERIORITY_OR_OTHER||Estimated rate difference|-4.4|STANDARD_ERROR_OF_MEAN|7.51||0.5574|TWO_SIDED|60.0|-10.72|1.91|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 66||1.91|-10.72|0.5574
72367387|NCT00658359|144245334|SUPERIORITY_OR_OTHER||Estimated rate difference|-2.3|STANDARD_ERROR_OF_MEAN|7.87||0.7704|TWO_SIDED|60.0|-8.92|4.33|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 66||4.33|-8.92|0.7704
72367388|NCT00658359|144245334|SUPERIORITY_OR_OTHER||Estimated rate difference|-0.44|STANDARD_ERROR_OF_MEAN|7.83||0.9551|TWO_SIDED|60.0|-7.03|6.15|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 72||6.15|-7.03|0.9551
72367389|NCT00658359|144245334|SUPERIORITY_OR_OTHER||Estimated rate difference|-2.3|STANDARD_ERROR_OF_MEAN|7.87||0.7704|TWO_SIDED|60.0|-8.92|4.33|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 72||4.33|-8.92|0.7704
72367390|NCT00658359|144245334|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.75|STANDARD_ERROR_OF_MEAN|4.91||0.4455|TWO_SIDED|60.0|-0.39|7.89|||Wald Test|||Month 12||7.89|-0.39|0.4455
72367391|NCT00658359|144245334|SUPERIORITY_OR_OTHER||Estimated rate difference|-0.69|STANDARD_ERROR_OF_MEAN|4.34||0.873|TWO_SIDED|60.0|-4.35|2.96|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 12||2.96|-4.35|0.8730
72367392|NCT00658359|144245335|SUPERIORITY_OR_OTHER||Estimated rate difference|-6.98|STANDARD_ERROR_OF_MEAN|6.67||0.2957|TWO_SIDED|60.0|-12.6|-1.36|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 15||-1.36|-12.60|0.2957
72367393|NCT00658359|144245335|SUPERIORITY_OR_OTHER||Estimated rate difference|-3.65|STANDARD_ERROR_OF_MEAN|7.14||0.6097|TWO_SIDED|60.0|-9.66|2.37|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 15||2.37|-9.66|0.6097
72367394|NCT00658359|144245335|SUPERIORITY_OR_OTHER||Estimated rate difference|-8.57|STANDARD_ERROR_OF_MEAN|6.79||0.2064|TWO_SIDED|60.0|-14.28|-2.86|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 18||-2.86|-14.28|0.2064
72367395|NCT00658359|144245335|SUPERIORITY_OR_OTHER||Estimated rate difference|-5.24|STANDARD_ERROR_OF_MEAN|7.25||0.4696|TWO_SIDED|60.0|-11.34|0.86|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 18||0.86|-11.34|0.4696
72367396|NCT00658359|144245335|SUPERIORITY_OR_OTHER||Estimated rate difference|-8.57|STANDARD_ERROR_OF_MEAN|7.04||0.2238|TWO_SIDED|60.0|-14.5|-2.64|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 24||-2.64|-14.50|0.2238
72367397|NCT00658359|144245335|SUPERIORITY_OR_OTHER||Estimated rate difference|-4.96|STANDARD_ERROR_OF_MEAN|7.52||0.5093|TWO_SIDED|60.0|-11.29|1.37|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 24||1.37|-11.29|0.5093
72367398|NCT00658359|144245335|SUPERIORITY_OR_OTHER||Estimated rate difference|-8.57|STANDARD_ERROR_OF_MEAN|7.04||0.2238|TWO_SIDED|60.0|-14.5|-2.64|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 30||-2.64|-14.50|0.2238
72367399|NCT00658359|144245335|SUPERIORITY_OR_OTHER||Estimated rate difference|-2.16|STANDARD_ERROR_OF_MEAN|7.89||0.7846|TWO_SIDED|60.0|-8.8|4.48|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 30||4.48|-8.80|0.7846
72367400|NCT00658359|144245335|SUPERIORITY_OR_OTHER||Estimated rate difference|-10.3|STANDARD_ERROR_OF_MEAN|7.16||0.1501|TWO_SIDED|60.0|-16.33|-4.28|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 36||-4.28|-16.33|0.1501
72367401|NCT00658359|144245335|SUPERIORITY_OR_OTHER||Estimated rate difference|-3.89|STANDARD_ERROR_OF_MEAN|8.0||0.6263|TWO_SIDED|60.0|-10.62|2.84|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 36||2.84|-10.62|0.6263
72367402|NCT00658359|144245335|SUPERIORITY_OR_OTHER||Estimated rate difference|-12.44|STANDARD_ERROR_OF_MEAN|7.35||0.0905|TWO_SIDED|60.0|-18.62|-6.25|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 42||-6.25|-18.62|0.0905
72367403|NCT00658359|144245335|SUPERIORITY_OR_OTHER||Estimated rate difference|-6.03|STANDARD_ERROR_OF_MEAN|8.16||0.4604|TWO_SIDED|60.0|-12.9|0.84|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 42||0.84|-12.90|0.4604
72367404|NCT00658359|144245335|SUPERIORITY_OR_OTHER||Estimated rate difference|-12.44|STANDARD_ERROR_OF_MEAN|7.35||0.0905|TWO_SIDED|60.0|-18.62|-6.25|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 48||-6.25|-18.62|0.0905
72367405|NCT00658359|144245335|SUPERIORITY_OR_OTHER||Estimated rate difference|-6.03|STANDARD_ERROR_OF_MEAN|8.16||0.4604|TWO_SIDED|60.0|-12.9|0.84|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 48||0.84|-12.90|0.4604
72367406|NCT00658359|144245335|SUPERIORITY_OR_OTHER||Estimated rate difference|-12.44|STANDARD_ERROR_OF_MEAN|7.35||0.0905|TWO_SIDED|60.0|-18.62|-6.25|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 54||-6.25|-18.62|0.0905
72367407|NCT00658359|144245335|SUPERIORITY_OR_OTHER||Estimated rate difference|-6.03|STANDARD_ERROR_OF_MEAN|8.16||0.4604|TWO_SIDED|60.0|-12.9|0.84|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 54||0.84|-12.90|0.4604
72367408|NCT00658359|144245335|SUPERIORITY_OR_OTHER||Estimated rate difference|-12.44|STANDARD_ERROR_OF_MEAN|7.35||0.0905|TWO_SIDED|60.0|-18.62|-6.25|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 60||-6.25|-18.62|0.0905
72367409|NCT00658359|144245335|SUPERIORITY_OR_OTHER||Estimated rate difference|-6.03|STANDARD_ERROR_OF_MEAN|8.16||0.4604|TWO_SIDED|60.0|-12.9|0.84|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 60||0.84|-12.90|0.4604
72367410|NCT00658359|144245335|SUPERIORITY_OR_OTHER||Estimated rate difference|-12.44|STANDARD_ERROR_OF_MEAN|7.35||0.0905|TWO_SIDED|60.0|-18.62|-6.25|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 66||-6.25|-18.62|0.0905
72367411|NCT00658359|144245335|SUPERIORITY_OR_OTHER||Estimated rate difference|-6.03|STANDARD_ERROR_OF_MEAN|8.16||0.4604|TWO_SIDED|60.0|-12.9|0.84|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 66||0.84|-12.90|0.4604
72367412|NCT00658359|144245335|SUPERIORITY_OR_OTHER||Estimated rate difference|-12.44|STANDARD_ERROR_OF_MEAN|7.35||0.0905|TWO_SIDED|60.0|-18.62|-6.25|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 72||-6.25|-18.62|0.0905
72367413|NCT00658359|144245335|SUPERIORITY_OR_OTHER||Estimated rate difference|-6.03|STANDARD_ERROR_OF_MEAN|8.16||0.4604|TWO_SIDED|60.0|-12.9|0.84|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 72||0.84|-12.90|0.4604
72367414|NCT00658359|144245335|SUPERIORITY_OR_OTHER||Estimated rate difference|-2.29|STANDARD_ERROR_OF_MEAN|6.31||0.7166|TWO_SIDED|60.0|-7.61|3.02|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 12||3.02|-7.61|0.7166
72367415|NCT00658359|144245335|SUPERIORITY_OR_OTHER||Estimated rate difference|-4.51|STANDARD_ERROR_OF_MEAN|6.24||0.4692|TWO_SIDED|60.0|-9.76|0.73|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 12||0.73|-9.76|0.4692
72367416|NCT00658359|144245336|SUPERIORITY_OR_OTHER||Estimated rate difference|1.69|STANDARD_ERROR_OF_MEAN|1.68||0.3132|TWO_SIDED|60.0|0.28|3.11|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 30||3.11|0.28|0.3132
72367417|NCT00658359|144245336|SUPERIORITY_OR_OTHER||Estimated rate difference|1.69|STANDARD_ERROR_OF_MEAN|1.68||0.3132|TWO_SIDED|60.0|0.28|3.11|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 30||3.11|0.28|0.3132
72367418|NCT00658359|144245336|SUPERIORITY_OR_OTHER||Estimated rate difference|3.52|STANDARD_ERROR_OF_MEAN|2.44||0.1503|TWO_SIDED|60.0|1.46|5.57|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 36||5.57|1.46|0.1503
72367419|NCT00658359|144245336|SUPERIORITY_OR_OTHER||Estimated rate difference|3.52|STANDARD_ERROR_OF_MEAN|2.44||0.1503|TWO_SIDED|60.0|1.46|5.57|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 36||5.57|1.46|0.1503
72367420|NCT00658359|144245336|SUPERIORITY_OR_OTHER||Estimated rate difference|3.52|STANDARD_ERROR_OF_MEAN|2.44||0.1503|TWO_SIDED|60.0|1.46|5.57|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 42||5.57|1.46|0.1503
72367421|NCT00658359|144245336|SUPERIORITY_OR_OTHER||Estimated rate difference|3.52|STANDARD_ERROR_OF_MEAN|2.44||0.1503|TWO_SIDED|60.0|1.46|5.57|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 42||5.57|1.46|0.1503
72367422|NCT00658359|144245336|SUPERIORITY_OR_OTHER||Estimated rate difference|3.52|STANDARD_ERROR_OF_MEAN|2.44||0.1503|TWO_SIDED|60.0|1.46|5.57|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 48||5.57|1.46|0.1503
72367423|NCT00658359|144245336|SUPERIORITY_OR_OTHER||Estimated rate difference|3.52|STANDARD_ERROR_OF_MEAN|2.44||0.1503|TWO_SIDED|60.0|1.46|5.57|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 48||5.57|1.46|0.1503
72367424|NCT00658359|144245336|SUPERIORITY_OR_OTHER||Estimated rate difference|3.52|STANDARD_ERROR_OF_MEAN|2.44||0.1503|TWO_SIDED|60.0|1.46|5.57|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 54||5.57|1.46|0.1503
72367425|NCT00658359|144245336|SUPERIORITY_OR_OTHER||Estimated rate difference|3.52|STANDARD_ERROR_OF_MEAN|2.44||0.1503|TWO_SIDED|60.0|1.46|5.57|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 54||5.57|1.46|0.1503
72367426|NCT00658359|144245336|SUPERIORITY_OR_OTHER||Estimated rate difference|3.52|STANDARD_ERROR_OF_MEAN|2.44||0.1503|TWO_SIDED|60.0|1.46|5.57|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 60||5.57|1.46|0.1503
72367427|NCT00658359|144245336|SUPERIORITY_OR_OTHER||Estimated rate difference|3.52|STANDARD_ERROR_OF_MEAN|2.44||0.1503|TWO_SIDED|60.0|1.46|5.57|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 60||5.57|1.46|0.1503
72367428|NCT00658359|144245336|SUPERIORITY_OR_OTHER||Estimated rate difference|3.52|STANDARD_ERROR_OF_MEAN|2.44||0.1503|TWO_SIDED|60.0|1.46|5.57|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 66||5.57|1.46|0.1503
72367429|NCT00658359|144245336|SUPERIORITY_OR_OTHER||Estimated rate difference|3.52|STANDARD_ERROR_OF_MEAN|2.44||0.1503|TWO_SIDED|60.0|1.46|5.57|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 66||5.57|1.46|0.1503
72367430|NCT00658359|144245336|SUPERIORITY_OR_OTHER||Estimated rate difference|3.52|STANDARD_ERROR_OF_MEAN|2.44||0.1503|TWO_SIDED|60.0|1.46|5.57|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 72||5.57|1.46|0.1503
72367431|NCT00658359|144245337|SUPERIORITY_OR_OTHER||Estimated rate difference|-1.85|STANDARD_ERROR_OF_MEAN|1.83||0.3128|TWO_SIDED|60.0|-3.4|-0.31|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 15||-0.31|-3.40|0.3128
72367432|NCT00658359|144245337|SUPERIORITY_OR_OTHER||Estimated rate difference|1.59|STANDARD_ERROR_OF_MEAN|1.57||0.3134|TWO_SIDED|60.0|0.26|2.91|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 18||2.91|0.26|0.3134
72367433|NCT00658359|144245337|SUPERIORITY_OR_OTHER||Estimated rate difference|-0.26|STANDARD_ERROR_OF_MEAN|2.42||0.9129|TWO_SIDED|60.0|-2.3|1.77|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 18||1.77|-2.30|0.9129
72367434|NCT00658359|144245337|SUPERIORITY_OR_OTHER||Estimated rate difference|1.59|STANDARD_ERROR_OF_MEAN|1.57||0.3134|TWO_SIDED|60.0|0.26|2.91|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 24||2.91|0.26|0.3134
72367435|NCT00658359|144245337|SUPERIORITY_OR_OTHER||Estimated rate difference|-4.19|STANDARD_ERROR_OF_MEAN|3.61||0.2447|TWO_SIDED|60.0|-7.23|-1.16|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 24||-1.16|-7.23|0.2447
72367436|NCT00658359|144245337|SUPERIORITY_OR_OTHER||Estimated rate difference|1.59|STANDARD_ERROR_OF_MEAN|1.57||0.3134|TWO_SIDED|60.0|0.26|2.91|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 30||2.91|0.26|0.3134
72367437|NCT00658359|144245337|SUPERIORITY_OR_OTHER||Estimated rate difference|-4.19|STANDARD_ERROR_OF_MEAN|3.61||0.2447|TWO_SIDED|60.0|-7.23|-1.16|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 30||-1.16|-7.23|0.2447
72367438|NCT00658359|144245337|SUPERIORITY_OR_OTHER||Estimated rate difference|1.59|STANDARD_ERROR_OF_MEAN|1.57||0.3134|TWO_SIDED|60.0|0.26|2.91|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 36||2.91|0.26|0.3134
72367439|NCT00658359|144245337|SUPERIORITY_OR_OTHER||Estimated rate difference|-7.44|STANDARD_ERROR_OF_MEAN|4.74||0.1164|TWO_SIDED|60.0|-11.43|-3.45|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 36||-3.45|-11.43|0.1164
72367440|NCT00658359|144245337|SUPERIORITY_OR_OTHER||Estimated rate difference|3.73|STANDARD_ERROR_OF_MEAN|2.62||0.1545|TWO_SIDED|60.0|1.52|5.93|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 42||5.93|1.52|0.1545
72367441|NCT00658359|144245337|SUPERIORITY_OR_OTHER||Estimated rate difference|-5.3|STANDARD_ERROR_OF_MEAN|5.18||0.3061|TWO_SIDED|60.0|-9.66|-0.94|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 42||-0.94|-9.66|0.3061
72367442|NCT00658359|144245337|SUPERIORITY_OR_OTHER||Estimated rate difference|3.73|STANDARD_ERROR_OF_MEAN|2.62||0.1545|TWO_SIDED|60.0|1.52|5.93|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 48||5.93|1.52|0.1545
72367443|NCT00658359|144245337|SUPERIORITY_OR_OTHER||Estimated rate difference|-5.3|STANDARD_ERROR_OF_MEAN|5.18||0.3061|TWO_SIDED|60.0|-9.66|-0.94|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 48||-0.94|-9.66|0.3061
72367444|NCT00658359|144245337|SUPERIORITY_OR_OTHER||Estimated rate difference|5.91|STANDARD_ERROR_OF_MEAN|3.35||0.0774|TWO_SIDED|60.0|3.1|8.73|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 54||8.73|3.10|0.0774
72367445|NCT00658359|144245337|SUPERIORITY_OR_OTHER||Estimated rate difference|-3.12|STANDARD_ERROR_OF_MEAN|5.59||0.5772|TWO_SIDED|60.0|-7.82|1.59|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 54||1.59|-7.82|0.5772
72367446|NCT00658359|144245337|SUPERIORITY_OR_OTHER||Estimated rate difference|5.91|STANDARD_ERROR_OF_MEAN|3.35||0.0774|TWO_SIDED|60.0|3.1|8.73|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 60||8.73|3.10|0.0774
72367447|NCT00658359|144245337|SUPERIORITY_OR_OTHER||Estimated rate difference|-3.12|STANDARD_ERROR_OF_MEAN|5.59||0.5772|TWO_SIDED|60.0|-7.82|1.59|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 60||1.59|-7.82|0.5772
72367448|NCT00658359|144245337|SUPERIORITY_OR_OTHER||Estimated rate difference|5.91|STANDARD_ERROR_OF_MEAN|3.35||0.0774|TWO_SIDED|60.0|3.1|8.73|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 66||8.73|3.10|0.0774
72367449|NCT00658359|144245337|SUPERIORITY_OR_OTHER||Estimated rate difference|-3.12|STANDARD_ERROR_OF_MEAN|5.59||0.5772|TWO_SIDED|60.0|-7.82|1.59|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 66||1.59|-7.82|0.5772
72367450|NCT00658359|144245337|SUPERIORITY_OR_OTHER||Estimated rate difference|5.91|STANDARD_ERROR_OF_MEAN|3.35||0.0774|TWO_SIDED|60.0|3.1|8.73|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 72||8.73|3.10|0.0774
72367451|NCT00658359|144245337|SUPERIORITY_OR_OTHER||Estimated rate difference|-3.12|STANDARD_ERROR_OF_MEAN|5.59||0.5772|TWO_SIDED|60.0|-7.82|1.59|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 72||1.59|-7.82|0.5772
72367452|NCT00658359|144245339|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.35|STANDARD_ERROR_OF_MEAN|8.15||0.0786|TWO_SIDED|60.0|7.49|21.22|||Mixed Models Analysis|||Month 15||21.22|7.49|0.0786
72367453|NCT00658359|144245339|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.87|STANDARD_ERROR_OF_MEAN|8.5||0.736|TWO_SIDED|60.0|-10.03|4.29|||Mixed Models Analysis|||Month 15||4.29|-10.03|0.7360
72367454|NCT00658359|144245339|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.16|STANDARD_ERROR_OF_MEAN|8.19||0.1377|TWO_SIDED|60.0|5.27|19.05|||Mixed Models Analysis|||Month 18||19.05|5.27|0.1377
72367455|NCT00658359|144245339|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.01|STANDARD_ERROR_OF_MEAN|8.56||0.4131|TWO_SIDED|60.0|-14.21|0.2|||Mixed Models Analysis|||Month 18||0.20|-14.21|0.4131
72367456|NCT00658359|144245339|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.52|STANDARD_ERROR_OF_MEAN|8.35||0.1057|TWO_SIDED|60.0|6.49|20.55|||Mixed Models Analysis|||Month 24||20.55|6.49|0.1057
72367457|NCT00658359|144245339|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.21|STANDARD_ERROR_OF_MEAN|8.95||0.1402|TWO_SIDED|60.0|-20.75|-5.68|||Mixed Models Analysis|||Month 24||-5.68|-20.75|0.1402
72367458|NCT00658359|144245339|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|17.6|STANDARD_ERROR_OF_MEAN|9.13||0.0542|TWO_SIDED|60.0|9.91|25.29|||Mixed Models Analysis|||Month 30||25.29|9.91|0.0542
72367459|NCT00658359|144245339|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.74|STANDARD_ERROR_OF_MEAN|10.09||0.3866|TWO_SIDED|60.0|0.24|17.24|||Mixed Models Analysis|||Month 30||17.24|0.24|0.3866
72367460|NCT00658359|144245339|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.52|STANDARD_ERROR_OF_MEAN|9.72||0.1981|TWO_SIDED|60.0|4.33|20.71|||Mixed Models Analysis|||Month 36||20.71|4.33|0.1981
72367461|NCT00658359|144245339|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.65|STANDARD_ERROR_OF_MEAN|12.07||0.6397|TWO_SIDED|60.0|-15.81|4.51|||Mixed Models Analysis|||Month 36||4.51|-15.81|0.6397
72367462|NCT00658359|144245339|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|19.93|STANDARD_ERROR_OF_MEAN|10.19||0.0508|TWO_SIDED|60.0|11.35|28.51|||Mixed Models Analysis|||Month 42||28.51|11.35|0.0508
72367463|NCT00658359|144245339|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.42|STANDARD_ERROR_OF_MEAN|12.9||0.5143|TWO_SIDED|60.0|-2.45|19.28|||Mixed Models Analysis|||Month 42||19.28|-2.45|0.5143
72367464|NCT00658359|144245339|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|32.26|STANDARD_ERROR_OF_MEAN|10.45||0.0021|TWO_SIDED|60.0|23.46|41.06|||Mixed Models Analysis|||Month 48||41.06|23.46|0.0021
72367465|NCT00658359|144245339|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.73|STANDARD_ERROR_OF_MEAN|13.47||0.5661|TWO_SIDED|60.0|-19.07|3.61|||Mixed Models Analysis|||Month 48||3.61|-19.07|0.5661
72367466|NCT00658359|144245339|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|29.2|STANDARD_ERROR_OF_MEAN|10.54||0.0057|TWO_SIDED|60.0|20.33|38.08|||Mixed Models Analysis|||Month 54||38.08|20.33|0.0057
72367467|NCT00658359|144245339|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.49|STANDARD_ERROR_OF_MEAN|13.89||0.4504|TWO_SIDED|60.0|-22.18|1.21|||Mixed Models Analysis|||Month 54||1.21|-22.18|0.4504
72367468|NCT00658359|144245339|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|30.37|STANDARD_ERROR_OF_MEAN|11.39||0.0078|TWO_SIDED|60.0|20.78|39.96|||Mixed Models Analysis|||Month 60||39.96|20.78|0.0078
72367469|NCT00658359|144245339|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.95|STANDARD_ERROR_OF_MEAN|14.44||0.6802|TWO_SIDED|60.0|-18.11|6.2|||Mixed Models Analysis|||Month 60||6.20|-18.11|0.6802
72367470|NCT00658359|144245339|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|27.78|STANDARD_ERROR_OF_MEAN|12.08||0.0216|TWO_SIDED|60.0|17.61|37.95|||Mixed Models Analysis|||Month 66||37.95|17.61|0.0216
72367471|NCT00658359|144245339|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.85|STANDARD_ERROR_OF_MEAN|15.12||0.9026|TWO_SIDED|60.0|-14.58|10.88|||Mixed Models Analysis|||Month 66||10.88|-14.58|0.9026
72367472|NCT00658359|144245339|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|20.38|STANDARD_ERROR_OF_MEAN|12.91||0.1146|TWO_SIDED|60.0|9.51|31.24|||Mixed Models Analysis|||Month 72||31.24|9.51|0.1146
72367473|NCT00658359|144245339|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.14|STANDARD_ERROR_OF_MEAN|15.48||0.6918|TWO_SIDED|60.0|-19.18|6.9|||Mixed Models Analysis|||Month 72||6.90|-19.18|0.6918
72367474|NCT00658359|144245340|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.62|STANDARD_ERROR_OF_MEAN|6.57||0.3139|TWO_SIDED|60.0|1.09|12.14|||Mixed Models Analysis|||Month 15||12.14|1.09|0.3139
72367475|NCT00658359|144245340|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.37|STANDARD_ERROR_OF_MEAN|6.75||0.5176|TWO_SIDED|60.0|-10.06|1.31|||Mixed Models Analysis|||Month 15||1.31|-10.06|0.5176
72367476|NCT00658359|144245340|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.54|STANDARD_ERROR_OF_MEAN|6.56||0.3191|TWO_SIDED|60.0|1.02|12.06|||Mixed Models Analysis|||Month 18||12.06|1.02|0.3191
72367477|NCT00658359|144245340|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.95|STANDARD_ERROR_OF_MEAN|6.73||0.6608|TWO_SIDED|60.0|-8.62|2.71|||Mixed Models Analysis|||Month 18||2.71|-8.62|0.6608
72367478|NCT00658359|144245340|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.02|STANDARD_ERROR_OF_MEAN|6.7||0.2319|TWO_SIDED|60.0|2.37|13.66|||Mixed Models Analysis|||Month 24||13.66|2.37|0.2319
72367479|NCT00658359|144245340|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.5|STANDARD_ERROR_OF_MEAN|7.04||0.3554|TWO_SIDED|60.0|-12.43|-0.58|||Mixed Models Analysis|||Month 24||-0.58|-12.43|0.3554
72367480|NCT00658359|144245340|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|18.45|STANDARD_ERROR_OF_MEAN|7.27||0.0113|TWO_SIDED|60.0|12.33|24.57|||Mixed Models Analysis|||Month 30||24.57|12.33|0.0113
72367481|NCT00658359|144245340|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.66|STANDARD_ERROR_OF_MEAN|7.99||0.479|TWO_SIDED|60.0|-1.07|12.39|||Mixed Models Analysis|||Month 30||12.39|-1.07|0.4790
72367482|NCT00658359|144245340|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.46|STANDARD_ERROR_OF_MEAN|7.75||0.1776|TWO_SIDED|60.0|3.93|16.99|||Mixed Models Analysis|||Month 36||16.99|3.93|0.1776
72367483|NCT00658359|144245340|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.27|STANDARD_ERROR_OF_MEAN|9.5||0.7307|TWO_SIDED|60.0|-11.27|4.73|||Mixed Models Analysis|||Month 36||4.73|-11.27|0.7307
72367484|NCT00658359|144245340|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.53|STANDARD_ERROR_OF_MEAN|8.25||0.1625|TWO_SIDED|60.0|4.59|18.48|||Mixed Models Analysis|||Month 42||18.48|4.59|0.1625
72367485|NCT00658359|144245340|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.77|STANDARD_ERROR_OF_MEAN|10.12||0.2876|TWO_SIDED|60.0|2.25|19.29|||Mixed Models Analysis|||Month 42||19.29|2.25|0.2876
72367486|NCT00658359|144245340|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|18.62|STANDARD_ERROR_OF_MEAN|8.41||0.027|TWO_SIDED|60.0|11.54|25.7|||Mixed Models Analysis|||Month 48||25.70|11.54|0.0270
72367487|NCT00658359|144245340|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.44|STANDARD_ERROR_OF_MEAN|10.54||0.7444|TWO_SIDED|60.0|-12.31|5.44|||Mixed Models Analysis|||Month 48||5.44|-12.31|0.7444
72367488|NCT00658359|144245340|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|21.18|STANDARD_ERROR_OF_MEAN|8.44||0.0122|TWO_SIDED|60.0|14.08|28.29|||Mixed Models Analysis|||Month 54||28.29|14.08|0.0122
72367489|NCT00658359|144245340|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.61|STANDARD_ERROR_OF_MEAN|10.86||0.3288|TWO_SIDED|60.0|-19.75|-1.47|||Mixed Models Analysis|||Month 54||-1.47|-19.75|0.3288
72367490|NCT00658359|144245340|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|18.34|STANDARD_ERROR_OF_MEAN|9.15||0.0453|TWO_SIDED|60.0|10.63|26.05|||Mixed Models Analysis|||Month 60||26.05|10.63|0.0453
72367491|NCT00658359|144245340|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.59|STANDARD_ERROR_OF_MEAN|11.28||0.5016|TWO_SIDED|60.0|-17.09|1.91|||Mixed Models Analysis|||Month 60||1.91|-17.09|0.5016
72367492|NCT00658359|144245340|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|19.43|STANDARD_ERROR_OF_MEAN|9.69||0.0453|TWO_SIDED|60.0|11.27|27.59|||Mixed Models Analysis|||Month 66||27.59|11.27|0.0453
72367493|NCT00658359|144245340|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.87|STANDARD_ERROR_OF_MEAN|11.84||0.8747|TWO_SIDED|60.0|-11.83|8.1|||Mixed Models Analysis|||Month 66||8.10|-11.83|0.8747
72367494|NCT00658359|144245340|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.98|STANDARD_ERROR_OF_MEAN|10.34||0.4997|TWO_SIDED|60.0|-1.72|15.69|||Mixed Models Analysis|||Month 72||15.69|-1.72|0.4997
72367495|NCT00658359|144245340|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.07|STANDARD_ERROR_OF_MEAN|12.1||0.2804|TWO_SIDED|60.0|-23.26|-2.88|||Mixed Models Analysis|||Month 72||-2.88|-23.26|0.2804
72367496|NCT00658359|144245341|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.79|STANDARD_ERROR_OF_MEAN|2.5|<|0.0001|TWO_SIDED|60.0|7.68|11.9|||Mixed Models Analysis|||Month 15||11.90|7.68|<0.0001
72367497|NCT00658359|144245341|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.32|STANDARD_ERROR_OF_MEAN|2.61||0.0418|TWO_SIDED|60.0|3.12|7.52|||Mixed Models Analysis|||Month 15||7.52|3.12|0.0418
72367498|NCT00658359|144245341|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.4|STANDARD_ERROR_OF_MEAN|2.51||0.0002|TWO_SIDED|60.0|7.28|11.51|||Mixed Models Analysis|||Month 18||11.51|7.28|0.0002
72367499|NCT00658359|144245341|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.3|STANDARD_ERROR_OF_MEAN|2.63||0.0437|TWO_SIDED|60.0|3.09|7.51|||Mixed Models Analysis|||Month 18||7.51|3.09|0.0437
72367500|NCT00658359|144245341|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.37|STANDARD_ERROR_OF_MEAN|2.56||0.0011|TWO_SIDED|60.0|6.21|10.53|||Mixed Models Analysis|||Month 24||10.53|6.21|0.0011
72367501|NCT00658359|144245341|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.04|STANDARD_ERROR_OF_MEAN|2.75||0.4565|TWO_SIDED|60.0|-0.27|4.36|||Mixed Models Analysis|||Month 24||4.36|-0.27|0.4565
72367502|NCT00658359|144245341|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.9|STANDARD_ERROR_OF_MEAN|2.8||0.0001|TWO_SIDED|60.0|8.54|13.26|||Mixed Models Analysis|||Month 30||13.26|8.54|0.0001
72367503|NCT00658359|144245341|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.29|STANDARD_ERROR_OF_MEAN|3.09||0.1654|TWO_SIDED|60.0|1.69|6.89|||Mixed Models Analysis|||Month 30||6.89|1.69|0.1654
72367504|NCT00658359|144245341|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.45|STANDARD_ERROR_OF_MEAN|2.98||0.0015|TWO_SIDED|60.0|6.95|11.96|||Mixed Models Analysis|||Month 36||11.96|6.95|0.0015
72367505|NCT00658359|144245341|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.13|STANDARD_ERROR_OF_MEAN|3.69||0.2636|TWO_SIDED|60.0|1.02|7.23|||Mixed Models Analysis|||Month 36||7.23|1.02|0.2636
72367506|NCT00658359|144245341|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.08|STANDARD_ERROR_OF_MEAN|3.12||0.052|TWO_SIDED|60.0|3.45|8.71|||Mixed Models Analysis|||Month 42||8.71|3.45|0.0520
72367507|NCT00658359|144245341|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.35|STANDARD_ERROR_OF_MEAN|3.95||0.176|TWO_SIDED|60.0|2.02|8.67|||Mixed Models Analysis|||Month 42||8.67|2.02|0.1760
72367508|NCT00658359|144245341|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.08|STANDARD_ERROR_OF_MEAN|3.2||0.0274|TWO_SIDED|60.0|4.38|9.77|||Mixed Models Analysis|||Month 48||9.77|4.38|0.0274
72367509|NCT00658359|144245341|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.04|STANDARD_ERROR_OF_MEAN|4.13||0.8018|TWO_SIDED|60.0|-4.51|2.44|||Mixed Models Analysis|||Month 48||2.44|-4.51|0.8018
72367510|NCT00658359|144245341|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.63|STANDARD_ERROR_OF_MEAN|3.23||0.0819|TWO_SIDED|60.0|2.91|8.35|||Mixed Models Analysis|||Month 54||8.35|2.91|0.0819
72367511|NCT00658359|144245341|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.17|STANDARD_ERROR_OF_MEAN|4.26||0.6103|TWO_SIDED|60.0|-5.75|1.41|||Mixed Models Analysis|||Month 54||1.41|-5.75|0.6103
72367512|NCT00658359|144245341|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.48|STANDARD_ERROR_OF_MEAN|3.49||0.1168|TWO_SIDED|60.0|2.54|8.41|||Mixed Models Analysis|||Month 60||8.41|2.54|0.1168
72367513|NCT00658359|144245341|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.26|STANDARD_ERROR_OF_MEAN|4.43||0.3357|TWO_SIDED|60.0|0.54|7.99|||Mixed Models Analysis|||Month 60||7.99|0.54|0.3357
72367514|NCT00658359|144245341|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.42|STANDARD_ERROR_OF_MEAN|3.7||0.0448|TWO_SIDED|60.0|4.31|10.54|||Mixed Models Analysis|||Month 66||10.54|4.31|0.0448
72367515|NCT00658359|144245341|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.39|STANDARD_ERROR_OF_MEAN|4.64||0.7642|TWO_SIDED|60.0|-2.51|5.29|||Mixed Models Analysis|||Month 66||5.29|-2.51|0.7642
72367516|NCT00658359|144245341|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.99|STANDARD_ERROR_OF_MEAN|3.95||0.1295|TWO_SIDED|60.0|2.67|9.32|||Mixed Models Analysis|||Month 72||9.32|2.67|0.1295
72367517|NCT00658359|144245341|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.13|STANDARD_ERROR_OF_MEAN|4.75||0.654|TWO_SIDED|60.0|-1.87|6.13|||Mixed Models Analysis|||Month 72||6.13|-1.87|0.6540
72367518|NCT00658359|144245342|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.11|STANDARD_ERROR_OF_MEAN|19.53||0.7543|TWO_SIDED|60.0|-22.55|10.33|||Mixed Models Analysis|||Month 15||10.33|-22.55|0.7543
72553283|NCT01077596|144637887|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.0||||||95.0|0.8|1.1|||||Adjusted for age, sex, cal year, study site, tumor characteristics, multiple antidepressants exposure, smoking, hysterectomy status, previous depression dx, previous IBD diagnosis, OC use, HRT/ERT use, and NSAID use.|||1.1|0.8|
72367519|NCT00658359|144245342|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.95|STANDARD_ERROR_OF_MEAN|20.33||0.6249|TWO_SIDED|60.0|-27.07|7.17|||Mixed Models Analysis|||Month 15||7.17|-27.07|0.6249
72367520|NCT00658359|144245342|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-18.66|STANDARD_ERROR_OF_MEAN|19.61||0.3415|TWO_SIDED|60.0|-35.17|-2.15|||Mixed Models Analysis|||Month 18||-2.15|-35.17|0.3415
72367521|NCT00658359|144245342|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-36.86|STANDARD_ERROR_OF_MEAN|20.47||0.072|TWO_SIDED|60.0|-54.1|-19.63|||Mixed Models Analysis|||Month 18||-19.63|-54.10|0.0720
72367522|NCT00658359|144245342|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-21.0|STANDARD_ERROR_OF_MEAN|19.99||0.2937|TWO_SIDED|60.0|-37.83|-4.17|||Mixed Models Analysis|||Month 24||-4.17|-37.83|0.2937
72367523|NCT00658359|144245342|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-41.72|STANDARD_ERROR_OF_MEAN|21.38||0.0512|TWO_SIDED|60.0|-59.72|-23.73|||Mixed Models Analysis|||Month 24||-23.73|-59.72|0.0512
72367524|NCT00658359|144245342|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-45.43|STANDARD_ERROR_OF_MEAN|21.76||0.037|TWO_SIDED|60.0|-63.75|-27.11|||Mixed Models Analysis|||Month 30||-27.11|-63.75|0.0370
72367525|NCT00658359|144245342|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.92|STANDARD_ERROR_OF_MEAN|24.0||0.8701|TWO_SIDED|60.0|-24.13|16.28|||Mixed Models Analysis|||Month 30||16.28|-24.13|0.8701
72367526|NCT00658359|144245342|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-28.75|STANDARD_ERROR_OF_MEAN|23.15||0.2146|TWO_SIDED|60.0|-48.24|-9.25|||Mixed Models Analysis|||Month 36||-9.25|-48.24|0.2146
72367527|NCT00658359|144245342|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-21.03|STANDARD_ERROR_OF_MEAN|28.58||0.462|TWO_SIDED|60.0|-45.09|3.03|||Mixed Models Analysis|||Month 36||3.03|-45.09|0.4620
72367528|NCT00658359|144245342|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.16|STANDARD_ERROR_OF_MEAN|24.28||0.8639|TWO_SIDED|60.0|-16.28|24.6|||Mixed Models Analysis|||Month 42||24.60|-16.28|0.8639
72367529|NCT00658359|144245342|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-30.3|STANDARD_ERROR_OF_MEAN|30.65||0.323|TWO_SIDED|60.0|-56.11|-4.5|||Mixed Models Analysis|||Month 42||-4.50|-56.11|0.3230
72367530|NCT00658359|144245342|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|30.49|STANDARD_ERROR_OF_MEAN|24.92||0.2214|TWO_SIDED|60.0|9.51|51.47|||Mixed Models Analysis|||Month 48||51.47|9.51|0.2214
72367531|NCT00658359|144245342|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.25|STANDARD_ERROR_OF_MEAN|32.08||0.7492|TWO_SIDED|60.0|-37.26|16.75|||Mixed Models Analysis|||Month 48||16.75|-37.26|0.7492
72367532|NCT00658359|144245342|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.61|STANDARD_ERROR_OF_MEAN|25.15||0.8236|TWO_SIDED|60.0|-15.57|26.79|||Mixed Models Analysis|||Month 54||26.79|-15.57|0.8236
72367533|NCT00658359|144245342|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.67|STANDARD_ERROR_OF_MEAN|33.1||0.6578|TWO_SIDED|60.0|-13.2|42.54|||Mixed Models Analysis|||Month 54||42.54|-13.20|0.6578
72367534|NCT00658359|144245342|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.93|STANDARD_ERROR_OF_MEAN|27.12||0.5326|TWO_SIDED|60.0|-5.9|39.76|||Mixed Models Analysis|||Month 60||39.76|-5.90|0.5326
72367535|NCT00658359|144245342|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.0|STANDARD_ERROR_OF_MEAN|34.44||0.6845|TWO_SIDED|60.0|-42.99|15.0|||Mixed Models Analysis|||Month 60||15.00|-42.99|0.6845
72367536|NCT00658359|144245342|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.35|STANDARD_ERROR_OF_MEAN|28.73||0.7713|TWO_SIDED|60.0|-15.83|32.54|||Mixed Models Analysis|||Month 66||32.54|-15.83|0.7713
72367537|NCT00658359|144245342|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.11|STANDARD_ERROR_OF_MEAN|36.06||0.8438|TWO_SIDED|60.0|-37.47|23.26|||Mixed Models Analysis|||Month 66||23.26|-37.47|0.8438
72367538|NCT00658359|144245342|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|22.06|STANDARD_ERROR_OF_MEAN|30.7||0.4724|TWO_SIDED|60.0|-3.78|47.91|||Mixed Models Analysis|||Month 72||47.91|-3.78|0.4724
72367539|NCT00658359|144245342|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|18.25|STANDARD_ERROR_OF_MEAN|36.98||0.6218|TWO_SIDED|60.0|-12.89|49.38|||Mixed Models Analysis|||Month 72||49.38|-12.89|0.6218
72367540|NCT00658359|144245346|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.33|STANDARD_ERROR_OF_MEAN|7.93||0.7693|TWO_SIDED|60.0|-9.01|4.35|||Mixed Models Analysis|||Month 15||4.35|-9.01|0.7693
72367541|NCT00658359|144245346|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.75|STANDARD_ERROR_OF_MEAN|8.28||0.7396|TWO_SIDED|60.0|-4.22|9.73|||Mixed Models Analysis|||Month 15||9.73|-4.22|0.7396
72367542|NCT00658359|144245346|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.84|STANDARD_ERROR_OF_MEAN|7.92||0.3881|TWO_SIDED|60.0|-13.51|-0.17|||Mixed Models Analysis|||Month 18||-0.17|-13.51|0.3881
72553284|NCT01077596|144637887|SUPERIORITY_OR_OTHER||Crude Odds Ratio|1.0||||||95.0|0.8|1.1||||||||1.1|0.8|
72367543|NCT00658359|144245346|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.44|STANDARD_ERROR_OF_MEAN|8.28||0.5114|TWO_SIDED|60.0|-12.42|1.53|||Mixed Models Analysis|||Month 18||1.53|-12.42|0.5114
72367544|NCT00658359|144245346|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.43|STANDARD_ERROR_OF_MEAN|8.06||0.5829|TWO_SIDED|60.0|-11.21|2.36|||Mixed Models Analysis|||Month 24||2.36|-11.21|0.5829
72367545|NCT00658359|144245346|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.76|STANDARD_ERROR_OF_MEAN|8.58||0.2559|TWO_SIDED|60.0|-16.99|-2.53|||Mixed Models Analysis|||Month 24||-2.53|-16.99|0.2559
72367546|NCT00658359|144245346|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.74|STANDARD_ERROR_OF_MEAN|8.78||0.7548|TWO_SIDED|60.0|-4.65|10.14|||Mixed Models Analysis|||Month 30||10.14|-4.65|0.7548
72367547|NCT00658359|144245346|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.43|STANDARD_ERROR_OF_MEAN|9.57||0.7998|TWO_SIDED|60.0|-5.63|10.49|||Mixed Models Analysis|||Match 30||10.49|-5.63|0.7998
72367548|NCT00658359|144245346|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.39|STANDARD_ERROR_OF_MEAN|9.08||0.2531|TWO_SIDED|60.0|2.74|18.03|||Mixed Models Analysis|||Month 36||18.03|2.74|0.2531
72367549|NCT00658359|144245346|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.14|STANDARD_ERROR_OF_MEAN|11.2||0.365|TWO_SIDED|60.0|0.72|19.57|||Mixed Models Analysis|||Month 36||19.57|0.72|0.3650
72367550|NCT00658359|144245346|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.33|STANDARD_ERROR_OF_MEAN|9.34||0.4328|TWO_SIDED|60.0|-0.53|15.19|||Mixed Models Analysis|||Month 42||15.19|-0.53|0.4328
72367551|NCT00658359|144245346|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.94|STANDARD_ERROR_OF_MEAN|11.35||0.2547|TWO_SIDED|60.0|-22.5|-3.38|||Mixed Models Analysis|||Month 42||-3.38|-22.50|0.2547
72367552|NCT00658359|144245346|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.72|STANDARD_ERROR_OF_MEAN|9.46||0.3572|TWO_SIDED|60.0|0.75|16.69|||Mixed Models Analysis|||Month 48||16.69|0.75|0.3572
72367553|NCT00658359|144245346|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.94|STANDARD_ERROR_OF_MEAN|11.64||0.8009|TWO_SIDED|60.0|-6.86|12.74|||Mixed Models Analysis|||Month 48||12.74|-6.86|0.8009
72367554|NCT00658359|144245346|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.88|STANDARD_ERROR_OF_MEAN|9.44||0.6814|TWO_SIDED|60.0|-11.82|4.07|||Mixed Models Analysis|||Month 54||4.07|-11.82|0.6814
72367555|NCT00658359|144245346|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.88|STANDARD_ERROR_OF_MEAN|11.93||0.2803|TWO_SIDED|60.0|2.84|22.93|||Mixed Models Analysis|||Month 54||22.93|2.84|0.2803
72367556|NCT00658359|144245346|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.11|STANDARD_ERROR_OF_MEAN|10.23||0.7613|TWO_SIDED|60.0|-11.72|5.5|||Mixed Models Analysis|||Month 60||5.50|-11.72|0.7613
72367557|NCT00658359|144245346|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.25|STANDARD_ERROR_OF_MEAN|12.35||0.8554|TWO_SIDED|60.0|-12.65|8.15|||Mixed Models Analysis|||Month 60||8.15|-12.65|0.8554
72367558|NCT00658359|144245346|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.17|STANDARD_ERROR_OF_MEAN|10.7||0.9132|TWO_SIDED|60.0|-10.18|7.84|||Mixed Models Analysis|||Month 66||7.84|-10.18|0.9132
72367559|NCT00658359|144245346|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.14|STANDARD_ERROR_OF_MEAN|12.79||0.7465|TWO_SIDED|60.0|-6.63|14.9|||Mixed Models Analysis|||Month 66||14.90|-6.63|0.7465
72367560|NCT00658359|144245346|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.79|STANDARD_ERROR_OF_MEAN|11.34||0.8747|TWO_SIDED|60.0|-11.34|7.76|||Mixed Models Analysis|||Month 72||7.76|-11.34|0.8747
72367561|NCT00658359|144245346|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.19|STANDARD_ERROR_OF_MEAN|12.96||0.5793|TWO_SIDED|60.0|-18.1|3.72|||Mixed Models Analysis|||Month 72||3.72|-18.10|0.5793
72367562|NCT00658359|144245348|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.76|STANDARD_ERROR_OF_MEAN|2.79|<|0.0001|TWO_SIDED|60.0|10.4|15.11|||Mixed Models Analysis|||Month 15||15.11|10.40|<0.0001
72367563|NCT00658359|144245348|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.39|STANDARD_ERROR_OF_MEAN|2.88|<|0.0001|TWO_SIDED|60.0|10.96|15.82|||Mixed Models Analysis|||Month 15||15.82|10.96|<0.0001
72367564|NCT00658359|144245348|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.48|STANDARD_ERROR_OF_MEAN|3.0||0.0002|TWO_SIDED|60.0|8.95|14.0|||Mixed Models Analysis|||Month 18||14.00|8.95|0.0002
72367565|NCT00658359|144245348|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.98|STANDARD_ERROR_OF_MEAN|3.09||0.0002|TWO_SIDED|60.0|9.37|14.59|||Mixed Models Analysis|||Month 18||14.59|9.37|0.0002
72367566|NCT00658359|144245348|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.86|STANDARD_ERROR_OF_MEAN|3.0|<|0.0001|TWO_SIDED|60.0|10.32|15.39|||Mixed Models Analysis|||Month 24||15.39|10.32|<0.0001
72367567|NCT00658359|144245348|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.71|STANDARD_ERROR_OF_MEAN|3.12|<|0.0001|TWO_SIDED|60.0|11.08|16.35|||Mixed Models Analysis|||Month 24||16.35|11.08|<0.0001
72367568|NCT00658359|144245348|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|15.86|STANDARD_ERROR_OF_MEAN|3.35|<|0.0001|TWO_SIDED|60.0|13.03|18.69|||Mixed Models Analysis|||Month 30||18.69|13.03|<0.0001
72367569|NCT00658359|144245348|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.61|STANDARD_ERROR_OF_MEAN|3.56||0.0002|TWO_SIDED|60.0|10.61|16.61|||Mixed Models Analysis|||Month 30||16.61|10.61|0.0002
72367570|NCT00658359|144245348|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.17|STANDARD_ERROR_OF_MEAN|3.61||0.001|TWO_SIDED|60.0|9.12|15.21|||Mixed Models Analysis|||Month 36||15.21|9.12|0.0010
72367571|NCT00658359|144245348|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.56|STANDARD_ERROR_OF_MEAN|3.98||0.0019|TWO_SIDED|60.0|9.2|15.92|||Mixed Models Analysis|||Month 36||15.92|9.20|0.0019
72367572|NCT00658359|144245348|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.42|STANDARD_ERROR_OF_MEAN|3.38||0.0004|TWO_SIDED|60.0|9.56|15.27|||Mixed Models Analysis|||Month 42||15.27|9.56|0.0004
72367573|NCT00658359|144245348|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.99|STANDARD_ERROR_OF_MEAN|3.76||0.0182|TWO_SIDED|60.0|5.81|12.16|||Mixed Models Analysis|||Month 42||12.16|5.81|0.0182
72367574|NCT00658359|144245348|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.4|STANDARD_ERROR_OF_MEAN|3.77||0.0013|TWO_SIDED|60.0|9.22|15.58|||Mixed Models Analysis|||Month 48||15.58|9.22|0.0013
72367575|NCT00658359|144245348|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.6|STANDARD_ERROR_OF_MEAN|4.29||0.0782|TWO_SIDED|60.0|3.99|11.22|||Mixed Models Analysis|||Month 48||11.22|3.99|0.0782
72367576|NCT00658359|144245348|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.04|STANDARD_ERROR_OF_MEAN|4.02||0.0007|TWO_SIDED|60.0|10.64|17.43|||Mixed Models Analysis|||Month 54||17.43|10.64|0.0007
72367577|NCT00658359|144245348|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.23|STANDARD_ERROR_OF_MEAN|4.72||0.0322|TWO_SIDED|60.0|6.24|14.22|||Mixed Models Analysis|||Month 54||14.22|6.24|0.0322
72367578|NCT00658359|144245348|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.72|STANDARD_ERROR_OF_MEAN|3.7||0.0399|TWO_SIDED|60.0|4.59|10.86|||Mixed Models Analysis|||Month 60||10.86|4.59|0.0399
72367579|NCT00658359|144245348|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.11|STANDARD_ERROR_OF_MEAN|4.28||0.3391|TWO_SIDED|60.0|0.49|7.73|||Mixed Models Analysis|||Month 60||7.73|0.49|0.3391
72367580|NCT00658359|144245348|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.75|STANDARD_ERROR_OF_MEAN|4.23||0.0702|TWO_SIDED|60.0|4.17|11.33|||Mixed Models Analysis|||Month 66||11.33|4.17|0.0702
72367581|NCT00658359|144245348|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.02|STANDARD_ERROR_OF_MEAN|4.89||0.221|TWO_SIDED|60.0|1.89|10.15|||Mixed Models Analysis|||Month 66||10.15|1.89|0.2210
72367582|NCT00658359|144245348|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.03|STANDARD_ERROR_OF_MEAN|5.25||0.015|TWO_SIDED|60.0|8.59|17.46|||Mixed Models Analysis|||Month 72||17.46|8.59|0.0150
72367583|NCT00658359|144245348|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.27|STANDARD_ERROR_OF_MEAN|6.13||0.4875|TWO_SIDED|60.0|-0.91|9.45|||Mixed Models Analysis|||Month 72||9.45|-0.91|0.4875
72367584|NCT00658359|144245349|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.48|STANDARD_ERROR_OF_MEAN|4.33||0.001|TWO_SIDED|60.0|10.83|18.13|||Mixed Models Analysis|||Month 15||18.13|10.83|0.0010
72367585|NCT00658359|144245349|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.93|STANDARD_ERROR_OF_MEAN|4.47||0.001|TWO_SIDED|60.0|11.16|18.7|||Mixed Models Analysis|||Month 15||18.70|11.16|0.0010
72367586|NCT00658359|144245349|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.96|STANDARD_ERROR_OF_MEAN|4.5||0.0023|TWO_SIDED|60.0|10.16|17.76|||Mixed Models Analysis|||Month 18||17.76|10.16|0.0023
72367587|NCT00658359|144245349|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.57|STANDARD_ERROR_OF_MEAN|4.64||0.0039|TWO_SIDED|60.0|9.65|17.48|||Mixed Models Analysis|||Month 18||17.48|9.65|0.0039
72367588|NCT00658359|144245349|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|15.02|STANDARD_ERROR_OF_MEAN|4.72||0.0017|TWO_SIDED|60.0|11.04|19.0|||Mixed Models Analysis|||Month 24||19.00|11.04|0.0017
72367589|NCT00658359|144245349|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.93|STANDARD_ERROR_OF_MEAN|4.88||0.0026|TWO_SIDED|60.0|10.81|19.04|||Mixed Models Analysis|||Month 24||19.04|10.81|0.0026
72367590|NCT00658359|144245349|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|18.54|STANDARD_ERROR_OF_MEAN|5.06||0.0003|TWO_SIDED|60.0|14.27|22.81|||Mixed Models Analysis|||Month 30||22.81|14.27|0.0003
72367591|NCT00658359|144245349|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.45|STANDARD_ERROR_OF_MEAN|5.29||0.0022|TWO_SIDED|60.0|11.99|20.91|||Mixed Models Analysis|||Month 30||20.91|11.99|0.0022
72367592|NCT00658359|144245349|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|15.19|STANDARD_ERROR_OF_MEAN|5.51||0.0065|TWO_SIDED|60.0|10.55|19.84|||Mixed Models Analysis|||Month 36||19.84|10.55|0.0065
72367593|NCT00658359|144245349|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.93|STANDARD_ERROR_OF_MEAN|6.0||0.0137|TWO_SIDED|60.0|9.87|19.99|||Mixed Models Analysis|||Month 36||19.99|9.87|0.0137
72367594|NCT00658359|144245349|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.32|STANDARD_ERROR_OF_MEAN|5.12||0.0018|TWO_SIDED|60.0|11.99|20.64|||Mixed Models Analysis|||Month 42||20.64|11.99|0.0018
72367595|NCT00658359|144245349|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.24|STANDARD_ERROR_OF_MEAN|5.65||0.0316|TWO_SIDED|60.0|7.47|17.01|||Mixed Models Analysis|||Month 42||17.01|7.47|0.0316
72367596|NCT00658359|144245349|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.33|STANDARD_ERROR_OF_MEAN|5.64||0.0043|TWO_SIDED|60.0|11.57|21.09|||Mixed Models Analysis|||Month 48||21.09|11.57|0.0043
72367597|NCT00658359|144245349|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.8|STANDARD_ERROR_OF_MEAN|6.31||0.1226|TWO_SIDED|60.0|4.47|15.12|||Mixed Models Analysis|||Month 48||15.12|4.47|0.1226
72367598|NCT00658359|144245349|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.97|STANDARD_ERROR_OF_MEAN|5.7||0.0034|TWO_SIDED|60.0|12.17|21.78|||Mixed Models Analysis|||Month 54||21.78|12.17|0.0034
72367599|NCT00658359|144245349|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.79|STANDARD_ERROR_OF_MEAN|6.52||0.0724|TWO_SIDED|60.0|6.29|17.29|||Mixed Models Analysis|||Month 54||17.29|6.29|0.0724
72367600|NCT00658359|144245349|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.03|STANDARD_ERROR_OF_MEAN|5.92||0.1782|TWO_SIDED|60.0|3.02|13.03|||Mixed Models Analysis|||Month 60||13.03|3.02|0.1782
72367601|NCT00658359|144245349|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.66|STANDARD_ERROR_OF_MEAN|6.86||0.5947|TWO_SIDED|60.0|-2.14|9.46|||Mixed Models Analysis|||Month 66||9.46|-2.14|0.5947
72367602|NCT00658359|144245349|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.99|STANDARD_ERROR_OF_MEAN|5.68||0.081|TWO_SIDED|60.0|5.2|14.79|||Mixed Models Analysis|||Month 66||14.79|5.20|0.0810
72367603|NCT00658359|144245349|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.42|STANDARD_ERROR_OF_MEAN|6.38||0.3965|TWO_SIDED|60.0|0.04|10.81|||Mixed Models Analysis|||Month 66||10.81|0.04|0.3965
72367604|NCT00658359|144245349|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|17.16|STANDARD_ERROR_OF_MEAN|6.77||0.0128|TWO_SIDED|60.0|11.44|22.88|||Mixed Models Analysis|||Month 72||22.88|11.44|0.0128
72367605|NCT00658359|144245349|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.71|STANDARD_ERROR_OF_MEAN|7.83||0.5487|TWO_SIDED|60.0|-1.91|11.33|||Mixed Models Analysis|||Month 72||11.33|-1.91|0.5487
72367606|NCT00658359|144245350|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|15.87|STANDARD_ERROR_OF_MEAN|2.86|<|0.0001|TWO_SIDED|60.0|13.46|18.29|||Mixed Models Analysis|||Month 15||18.29|13.46|<0.0001
72367607|NCT00658359|144245350|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.97|STANDARD_ERROR_OF_MEAN|2.95|<|0.0001|TWO_SIDED|60.0|11.49|16.46|||Mixed Models Analysis|||Month 15||16.46|11.49|<0.0001
72367608|NCT00658359|144245350|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.53|STANDARD_ERROR_OF_MEAN|3.33|<|0.0001|TWO_SIDED|60.0|10.71|16.34|||Mixed Models Analysis|||Month 18||16.34|10.71|<0.0001
72367609|NCT00658359|144245350|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.56|STANDARD_ERROR_OF_MEAN|3.43||0.0009|TWO_SIDED|60.0|8.67|14.45|||Mixed Models Analysis|||Month 18||14.45|8.67|0.0009
72367610|NCT00658359|144245350|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|15.63|STANDARD_ERROR_OF_MEAN|3.44|<|0.0001|TWO_SIDED|60.0|12.72|18.53|||Mixed Models Analysis|||Month 24||18.53|12.72|<0.0001
72367611|NCT00658359|144245350|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.89|STANDARD_ERROR_OF_MEAN|3.54||0.001|TWO_SIDED|60.0|8.91|14.88|||Mixed Models Analysis|||Month 24||14.88|8.91|0.0010
72367612|NCT00658359|144245350|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|19.29|STANDARD_ERROR_OF_MEAN|3.86|<|0.0001|TWO_SIDED|60.0|16.03|22.55|||Mixed Models Analysis|||Month 30||22.55|16.03|<0.0001
72367613|NCT00658359|144245350|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.63|STANDARD_ERROR_OF_MEAN|3.97||0.0082|TWO_SIDED|60.0|7.27|13.98|||Mixed Models Analysis|||Month 30||13.98|7.27|0.0082
72367614|NCT00658359|144245350|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.72|STANDARD_ERROR_OF_MEAN|4.31||0.0008|TWO_SIDED|60.0|11.09|18.36|||Mixed Models Analysis|||Month 36||18.36|11.09|0.0008
72367615|NCT00658359|144245350|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.9|STANDARD_ERROR_OF_MEAN|4.43||0.0462|TWO_SIDED|60.0|5.16|12.64|||Mixed Models Analysis|||Month 36||12.64|5.16|0.0462
72367616|NCT00658359|144245350|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.7|STANDARD_ERROR_OF_MEAN|4.25||0.0007|TWO_SIDED|60.0|11.11|18.28|||Mixed Models Analysis|||Month 42||18.28|11.11|0.0007
72367617|NCT00658359|144245350|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.55|STANDARD_ERROR_OF_MEAN|4.37||0.0519|TWO_SIDED|60.0|4.87|12.24|||Mixed Models Analysis|||Month 42||12.24|4.87|0.0519
72367618|NCT00658359|144245350|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.58|STANDARD_ERROR_OF_MEAN|4.65||0.0039|TWO_SIDED|60.0|9.66|17.5|||Mixed Models Analysis|||Month 48||17.50|9.66|0.0039
72367619|NCT00658359|144245350|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.12|STANDARD_ERROR_OF_MEAN|4.78||0.058|TWO_SIDED|60.0|5.09|13.15|||Mixed Models Analysis|||Month 48||13.15|5.09|0.0580
72367620|NCT00658359|144245350|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.61|STANDARD_ERROR_OF_MEAN|4.74||0.0006|TWO_SIDED|60.0|12.62|20.61|||Mixed Models Analysis|||Month 54||20.61|12.62|0.0006
72367621|NCT00658359|144245350|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.15|STANDARD_ERROR_OF_MEAN|4.87||0.0136|TWO_SIDED|60.0|8.04|16.26|||Mixed Models Analysis|||Month 54||16.26|8.04|0.0136
72367622|NCT00658359|144245350|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.39|STANDARD_ERROR_OF_MEAN|4.74||0.0053|TWO_SIDED|60.0|9.39|17.39|||Mixed Models Analysis|||Month 60||17.39|9.39|0.0053
72367623|NCT00658359|144245350|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.77|STANDARD_ERROR_OF_MEAN|4.87||0.0736|TWO_SIDED|60.0|4.66|12.88|||Mixed Models Analysis|||Month 60||12.88|4.66|0.0736
72367624|NCT00658359|144245350|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.63|STANDARD_ERROR_OF_MEAN|4.8||0.005|TWO_SIDED|60.0|9.58|17.67|||Mixed Models Analysis|||Month 66||17.67|9.58|0.0050
72367625|NCT00658359|144245350|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.77|STANDARD_ERROR_OF_MEAN|4.93||0.0491|TWO_SIDED|60.0|5.61|13.93|||Mixed Models Analysis|||Month 66||13.93|5.61|0.0491
72367626|NCT00658359|144245350|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.66|STANDARD_ERROR_OF_MEAN|5.04||0.0041|TWO_SIDED|60.0|10.4|18.91|||Mixed Models Analysis|||Month 72||18.91|10.40|0.0041
72367627|NCT00658359|144245350|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.59|STANDARD_ERROR_OF_MEAN|5.19||0.066|TWO_SIDED|60.0|5.22|13.97|||Mixed Models Analysis|||Month 72||13.97|5.22|0.0660
72367628|NCT00658359|144245351|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.04|STANDARD_ERROR_OF_MEAN|1.73||0.2393|TWO_SIDED|95.0|-5.45|1.36|||Mixed Models Analysis|||Month 24: Physical Functioning||1.36|-5.45|0.2393
72367629|NCT00658359|144245351|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.57|STANDARD_ERROR_OF_MEAN|1.89||0.0595|TWO_SIDED|95.0|-7.29|0.14|||Mixed Models Analysis|||Month 24: Physical Functioning||0.14|-7.29|0.0595
72367630|NCT00658359|144245351|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.36|STANDARD_ERROR_OF_MEAN|2.1||0.5182|TWO_SIDED|95.0|-2.77|5.49|||Mixed Models Analysis|||Month 24: Role Physical||5.49|-2.77|0.5182
72367631|NCT00658359|144245351|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.96|STANDARD_ERROR_OF_MEAN|2.3||0.3938|TWO_SIDED|95.0|-6.49|2.56|||Mixed Models Analysis|||Month 24: Role Physical||2.56|-6.49|0.3938
72367632|NCT00658359|144245351|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.29|STANDARD_ERROR_OF_MEAN|2.12||0.8932|TWO_SIDED|95.0|-3.89|4.46|||Mixed Models Analysis|||Month 24: Bodily Pain||4.46|-3.89|0.8932
72367633|NCT00658359|144245351|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|2.33||0.9673|TWO_SIDED|95.0|-4.48|4.67|||Mixed Models Analysis|||Month 24: Bodily Pain||4.67|-4.48|0.9673
72367634|NCT00658359|144245351|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.74|STANDARD_ERROR_OF_MEAN|1.78||0.329|TWO_SIDED|95.0|-1.76|5.23|||Mixed Models Analysis|||Month 24: General Health||5.23|-1.76|0.3290
72367635|NCT00658359|144245351|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.09|STANDARD_ERROR_OF_MEAN|1.95||0.578|TWO_SIDED|95.0|-2.75|4.92|||Mixed Models Analysis|||Month 24: General Health||4.92|-2.75|0.5780
72367636|NCT00658359|144245351|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|1.87||0.9799|TWO_SIDED|95.0|-3.72|3.62|||Mixed Models Analysis|||Month 24: Vitality||3.62|-3.72|0.9799
72367637|NCT00658359|144245351|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.76|STANDARD_ERROR_OF_MEAN|2.07||0.396|TWO_SIDED|95.0|-2.31|5.83|||Mixed Models Analysis|||Month 24: Vitality||5.83|-2.31|0.3960
72367638|NCT00658359|144245351|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.15|STANDARD_ERROR_OF_MEAN|1.98||0.94|TWO_SIDED|95.0|-4.05|3.75|||Mixed Models Analysis|||Month 24: Social Functioning||3.75|-4.05|0.9400
72367639|NCT00658359|144245351|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.39|STANDARD_ERROR_OF_MEAN|2.2||0.8583|TWO_SIDED|95.0|-3.94|4.72|||Mixed Models Analysis|||Month 24: Social Functioning||4.72|-3.94|0.8583
72367640|NCT00658359|144245351|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.82|STANDARD_ERROR_OF_MEAN|2.31||0.0997|TWO_SIDED|95.0|-0.73|8.37|||Mixed Models Analysis|||Month 24: Role Emotional||8.37|-0.73|0.0997
72367641|NCT00658359|144245351|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.47|STANDARD_ERROR_OF_MEAN|2.54||0.852|TWO_SIDED|95.0|-5.47|4.52|||Mixed Models Analysis|||Month 24: Role Emotional||4.52|-5.47|0.8520
72367642|NCT00658359|144245351|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.69|STANDARD_ERROR_OF_MEAN|2.01||0.4023|TWO_SIDED|95.0|-5.64|2.27|||Mixed Models Analysis|||Month 24: Mental Health||2.27|-5.64|0.4023
72367643|NCT00658359|144245351|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.56|STANDARD_ERROR_OF_MEAN|2.22||0.1092|TWO_SIDED|95.0|-0.8|7.92|||Mixed Models Analysis|||Month 24: Mental Health||7.92|-0.80|0.1092
72367644|NCT00658359|144245351|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.21|STANDARD_ERROR_OF_MEAN|0.16||0.1754|TWO_SIDED|95.0|-0.1|0.52|||Mixed Models Analysis|||Month 24: TR Scale Score||0.52|-0.10|0.1754
72367645|NCT00658359|144245351|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.23|STANDARD_ERROR_OF_MEAN|0.17||0.1802|TWO_SIDED|95.0|-0.11|0.57|||Mixed Models Analysis|||Month 24: TR Scale Score||0.57|-0.11|0.1802
72367646|NCT00658359|144245351|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|1.68||0.9966|TWO_SIDED|95.0|-3.31|3.29|||Mixed Models Analysis|||Month 24: Physical Component Summary||3.29|-3.31|0.9966
72367647|NCT00658359|144245351|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.42|STANDARD_ERROR_OF_MEAN|1.84||0.188|TWO_SIDED|95.0|-6.04|1.19|||Mixed Models Analysis|||Month 24: Physical Component Summary||1.19|-6.04|0.1880
72367648|NCT00658359|144245351|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.96|STANDARD_ERROR_OF_MEAN|1.92||0.6154|TWO_SIDED|95.0|-2.81|4.73|||Mixed Models Analysis|||Month 24: Mental Component Summary||4.73|-2.81|0.6154
72367649|NCT00658359|144245351|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.26|STANDARD_ERROR_OF_MEAN|2.12||0.1248|TWO_SIDED|95.0|-0.91|7.43|||Mixed Models Analysis|||Month 24: Mental Component Summary||7.43|-0.91|0.1248
72367650|NCT00658359|144245351|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.65|STANDARD_ERROR_OF_MEAN|2.03||0.4174|TWO_SIDED|95.0|-5.63|2.34|||Mixed Models Analysis|||Month 36: Physical Functioning||2.34|-5.63|0.4174
72367651|NCT00658359|144245351|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.44|STANDARD_ERROR_OF_MEAN|2.6||0.3486|TWO_SIDED|95.0|-7.54|2.66|||Mixed Models Analysis|||Month 36: Physical Functioning||2.66|-7.54|0.3486
72367652|NCT00658359|144245351|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.52|STANDARD_ERROR_OF_MEAN|2.47||0.8335|TWO_SIDED|95.0|-4.33|5.37|||Mixed Models Analysis|||Month 36: Role Physical||5.37|-4.33|0.8335
72367653|NCT00658359|144245351|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.0|STANDARD_ERROR_OF_MEAN|3.18||0.5291|TWO_SIDED|95.0|-8.24|4.24|||Mixed Models Analysis|||Month 36: Role Physical||4.24|-8.24|0.5291
72367654|NCT00658359|144245351|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.09|STANDARD_ERROR_OF_MEAN|2.5||0.4033|TWO_SIDED|95.0|-2.82|7.0|||Mixed Models Analysis|||Month 36: Bodily Pain||7.00|-2.82|0.4033
72367655|NCT00658359|144245351|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.38|STANDARD_ERROR_OF_MEAN|3.24||0.9078|TWO_SIDED|95.0|-6.74|5.99|||Mixed Models Analysis|||Month 36: Bodily Pain||5.99|-6.74|0.9078
72367656|NCT00658359|144245351|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.77|STANDARD_ERROR_OF_MEAN|2.08||0.3947|TWO_SIDED|95.0|-2.31|5.86|||Mixed Models Analysis|||Month 36: General Health||5.86|-2.31|0.3947
72367657|NCT00658359|144245351|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.97|STANDARD_ERROR_OF_MEAN|2.66||0.7165|TWO_SIDED|95.0|-4.26|6.2|||Mixed Models Analysis|||Month 36: General Health||6.20|-4.26|0.7165
72367658|NCT00658359|144245351|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.44|STANDARD_ERROR_OF_MEAN|2.19||0.5112|TWO_SIDED|95.0|-2.87|5.75|||Mixed Models Analysis|||Month 36: Vitality||5.75|-2.87|0.5112
72367659|NCT00658359|144245351|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.43|STANDARD_ERROR_OF_MEAN|2.86||0.1218|TWO_SIDED|95.0|-1.18|10.04|||Mixed Models Analysis|||Month 36: Vitality||10.04|-1.18|0.1218
72367660|NCT00658359|144245351|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.47|STANDARD_ERROR_OF_MEAN|2.33||0.2895|TWO_SIDED|95.0|-2.11|7.05|||Mixed Models Analysis|||Month 36: Social Functioning||7.05|-2.11|0.2895
72367661|NCT00658359|144245351|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.63|STANDARD_ERROR_OF_MEAN|3.03||0.8349|TWO_SIDED|95.0|-6.58|5.32|||Mixed Models Analysis|||Month 36: Social Functioning||5.32|-6.58|0.8349
72367662|NCT00658359|144245351|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.62|STANDARD_ERROR_OF_MEAN|2.72||0.0393|TWO_SIDED|95.0|0.28|10.97|||Mixed Models Analysis|||Month 36: Role Emotional||10.97|0.28|0.0393
72367663|NCT00658359|144245351|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.23|STANDARD_ERROR_OF_MEAN|3.52||0.7266|TWO_SIDED|95.0|-5.69|8.16|||Mixed Models Analysis|||Month 36: Role Emotional||8.16|-5.69|0.7266
72367664|NCT00658359|144245351|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.63|STANDARD_ERROR_OF_MEAN|2.36||0.4916|TWO_SIDED|95.0|-3.02|6.27|||Mixed Models Analysis|||Month 36: Mental Health||6.27|-3.02|0.4916
72367665|NCT00658359|144245351|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.38|STANDARD_ERROR_OF_MEAN|3.05||0.9008|TWO_SIDED|95.0|-5.62|6.38|||Mixed Models Analysis|||Month 36: Mental Health||6.38|-5.62|0.9008
72367666|NCT00658359|144245351|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.19|STANDARD_ERROR_OF_MEAN|0.18||0.2965|TWO_SIDED|95.0|-0.17|0.55|||Mixed Models Analysis|||Month 36: TR Scale Score||0.55|-0.17|0.2965
72367667|NCT00658359|144245351|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.37|STANDARD_ERROR_OF_MEAN|0.24||0.1147|TWO_SIDED|95.0|-0.09|0.84|||Mixed Models Analysis|||Month 36: TR Scale Score||0.84|-0.09|0.1147
72367668|NCT00658359|144245351|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.55|STANDARD_ERROR_OF_MEAN|1.97||0.7786|TWO_SIDED|95.0|-4.42|3.31|||Mixed Models Analysis|||Month 36: Physical Component Summary||3.31|-4.42|0.7786
72367669|NCT00658359|144245351|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.48|STANDARD_ERROR_OF_MEAN|2.53||0.5582|TWO_SIDED|95.0|-6.45|3.49|||Mixed Models Analysis|||Month 36: Physical Component Summary||3.49|-6.45|0.5582
72367670|NCT00658359|144245351|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.05|STANDARD_ERROR_OF_MEAN|2.25||0.0727|TWO_SIDED|95.0|-0.37|8.47|||Mixed Models Analysis|||Month 36: Mental Component Summary||8.47|-0.37|0.0727
72367671|NCT00658359|144245351|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.86|STANDARD_ERROR_OF_MEAN|2.91||0.3264|TWO_SIDED|95.0|-2.86|8.59|||Mixed Models Analysis|||Month 36: Mental Component Summary||8.59|-2.86|0.3264
72367672|NCT00658359|144245352|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.11|STANDARD_ERROR_OF_MEAN|0.11||0.3093|TWO_SIDED|95.0|-0.1|0.33|||Mixed Models Analysis|||Month 24 Limited Physical Capacity||0.33|-0.10|0.3093
72367673|NCT00658359|144245352|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.12|STANDARD_ERROR_OF_MEAN|0.12||0.3223|TWO_SIDED|95.0|-0.12|0.36|||Mixed Models Analysis|||Month 24 Limited Physical Capacity||0.36|-0.12|0.3223
72367674|NCT00658359|144245352|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.08|STANDARD_ERROR_OF_MEAN|0.11||0.4858|TWO_SIDED|95.0|-0.14|0.3|||Mixed Models Analysis|||Month 24 Limited Cognitive Capacity||0.30|-0.14|0.4858
72367675|NCT00658359|144245352|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.11|STANDARD_ERROR_OF_MEAN|0.13||0.3679|TWO_SIDED|95.0|-0.13|0.36|||Mixed Models Analysis|||Month 24 Limited Cognitive Capacity||0.36|-0.13|0.3679
72367676|NCT00658359|144245352|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.11||0.6416|TWO_SIDED|95.0|-0.27|0.17|||Mixed Models Analysis|||Month 24 Cardiac and Renal Dysfunction||0.17|-0.27|0.6416
72367677|NCT00658359|144245352|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.12||0.4241|TWO_SIDED|95.0|-0.34|0.14|||Mixed Models Analysis|||Month 24 Cardiac and Renal Dysfunction||0.14|-0.34|0.4241
72367678|NCT00658359|144245352|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.15|STANDARD_ERROR_OF_MEAN|0.12||0.2133|TWO_SIDED|95.0|-0.09|0.39|||Mixed Models Analysis|||Month 24 Side Effects of Corticosteroids||0.39|-0.09|0.2133
72367679|NCT00658359|144245352|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.17|STANDARD_ERROR_OF_MEAN|0.13||0.1918|TWO_SIDED|95.0|-0.09|0.44|||Mixed Models Analysis|||Month 24 Side Effects of Corticosteroids||0.44|-0.09|0.1918
72367680|NCT00658359|144245352|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.35|STANDARD_ERROR_OF_MEAN|0.1||0.001|TWO_SIDED|95.0|-0.55|-0.14|||Mixed Models Analysis|||Month 24 Increased Growth of Gum and Hair||-0.14|-0.55|0.0010
72367681|NCT00658359|144245352|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.36|STANDARD_ERROR_OF_MEAN|0.12||0.002|TWO_SIDED|95.0|-0.59|-0.13|||Mixed Models Analysis|||Month 24 Increased Growth of Gum and Hair||-0.13|-0.59|0.0020
72367682|NCT00658359|144245352|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.16|STANDARD_ERROR_OF_MEAN|0.12||0.2012|TWO_SIDED|95.0|-0.08|0.4|||Mixed Models Analysis|||Month 24 Transplantation-Associated Psychological Distress||0.40|-0.08|0.2012
72367683|NCT00658359|144245352|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.14||0.8986|TWO_SIDED|95.0|-0.25|0.29|||Mixed Models Analysis|||Month 24 Transplantation-Associated Psychological Distress||0.29|-0.25|0.8986
72367684|NCT00658359|144245352|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.04|STANDARD_ERROR_OF_MEAN|0.08||0.6724|TWO_SIDED|95.0|-0.13|0.2|||Mixed Models Analysis|||Month 24 Global Score||0.20|-0.13|0.6724
72367685|NCT00658359|144245352|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.09||0.9297|TWO_SIDED|95.0|-0.18|0.19|||Mixed Models Analysis|||Month 24 Global Score||0.19|-0.18|0.9297
72367686|NCT00658359|144245352|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.13||0.8682|TWO_SIDED|95.0|-0.28|0.23|||Mixed Models Analysis|||Month 36 Limited Physical Capacity||0.23|-0.28|0.8682
72367687|NCT00658359|144245352|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.17|STANDARD_ERROR_OF_MEAN|0.18||0.3392|TWO_SIDED|95.0|-0.18|0.53|||Mixed Models Analysis|||Month 36 Limited Physical Capacity||0.53|-0.18|0.3392
72367688|NCT00658359|144245352|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.06|STANDARD_ERROR_OF_MEAN|0.13||0.6545|TWO_SIDED|95.0|-0.2|0.32|||Mixed Models Analysis|||Month 36 Limited Cognitive Capacity||0.32|-0.20|0.6545
72367689|NCT00658359|144245352|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.18|STANDARD_ERROR_OF_MEAN|0.19||0.3253|TWO_SIDED|95.0|-0.18|0.55|||Mixed Models Analysis|||Month 36 Limited Cognitive Capacity||0.55|-0.18|0.3253
72367690|NCT00658359|144245352|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.13||0.9698|TWO_SIDED|95.0|-0.26|0.25|||Mixed Models Analysis|||Month 36 Cardiac and Renal Dysfunction||0.25|-0.26|0.9698
72367691|NCT00658359|144245352|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.19|STANDARD_ERROR_OF_MEAN|0.18||0.3065|TWO_SIDED|95.0|-0.17|0.54|||Mixed Models Analysis|||Month 36 Cardiac and Renal Dysfunction||0.54|-0.17|0.3065
72367692|NCT00658359|144245352|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.14||0.7147|TWO_SIDED|95.0|-0.33|0.23|||Mixed Models Analysis|||Month 36 Side Effects of Corticosteroids||0.23|-0.33|0.7147
72367693|NCT00658359|144245352|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.14|STANDARD_ERROR_OF_MEAN|0.2||0.4852|TWO_SIDED|95.0|-0.25|0.53|||Mixed Models Analysis|||Month 36 Side Effects of Corticosteroids||0.53|-0.25|0.4852
72367694|NCT00658359|144245352|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.21|STANDARD_ERROR_OF_MEAN|0.13||0.0888|TWO_SIDED|95.0|-0.46|0.03|||Mixed Models Analysis|||Month 36 Increased Growth of Gum and Hair||0.03|-0.46|0.0888
72367695|NCT00658359|144245352|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.31|STANDARD_ERROR_OF_MEAN|0.17||0.0719|TWO_SIDED|95.0|-0.65|0.03|||Mixed Models Analysis|||Month 36 Increased Growth of Gum and Hair||0.03|-0.65|0.0719
72367696|NCT00658359|144245352|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.14||0.7531|TWO_SIDED|95.0|-0.24|0.33|||Mixed Models Analysis|||Month 36 Transplantation-Associated Psychological Distress||0.33|-0.24|0.7531
72367697|NCT00658359|144245352|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.09|STANDARD_ERROR_OF_MEAN|0.2||0.6412|TWO_SIDED|95.0|-0.49|0.3|||Mixed Models Analysis|||Month 36 Transplantation-Associated Psychological Distress||0.30|-0.49|0.6412
72367698|NCT00658359|144245352|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.1||0.9186|TWO_SIDED|95.0|-0.2|0.18|||Mixed Models Analysis|||Month 36 Global Score||0.18|-0.20|0.9186
72367699|NCT00658359|144245352|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.06|STANDARD_ERROR_OF_MEAN|0.14||0.6629|TWO_SIDED|95.0|-0.21|0.33|||Mixed Models Analysis|||Month 36 Global Score||0.33|-0.21|0.6629
72367700|NCT00658359|144245353|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.85|STANDARD_ERROR_OF_MEAN|1.72||0.2826|TWO_SIDED|95.0|-5.22|1.53|||Mixed Models Analysis|||Month 24 Pain Intensity Total Converted Score||1.53|-5.22|0.2826
72367701|NCT00658359|144245353|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.22|STANDARD_ERROR_OF_MEAN|1.97||0.5371|TWO_SIDED|95.0|-2.65|5.09|||Mixed Models Analysis|||Month 24 Pain Intensity Total Converted Score||5.09|-2.65|0.5371
72367702|NCT00658359|144245353|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.62||0.7503|TWO_SIDED|95.0|-1.41|1.02|||Mixed Models Analysis|||Month 24 Non-Pain Symptoms Converted Score||1.02|-1.41|0.7503
72367703|NCT00658359|144245353|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.81|STANDARD_ERROR_OF_MEAN|0.72||0.261|TWO_SIDED|95.0|-0.6|2.21|||Mixed Models Analysis|||Month 24 Non-Pain Symptoms Converted Score||2.21|-0.60|0.2610
72367704|NCT00658359|144245353|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.89|STANDARD_ERROR_OF_MEAN|0.98||0.3656|TWO_SIDED|95.0|-1.04|2.82|||Mixed Models Analysis|||Month 24 Satisfaction Converted Score||2.82|-1.04|0.3656
72367705|NCT00658359|144245353|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.89|STANDARD_ERROR_OF_MEAN|1.15||0.4405|TWO_SIDED|95.0|-3.16|1.37|||Mixed Models Analysis|||Month 24 Satisfaction Converted Score||1.37|-3.16|0.4405
72367706|NCT00658359|144245353|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.6|STANDARD_ERROR_OF_MEAN|1.96||0.4135|TWO_SIDED|95.0|-5.45|2.25|||Mixed Models Analysis|||Month 36 Pain Intensity Total Converted Score||2.25|-5.45|0.4135
72367707|NCT00658359|144245353|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.96|STANDARD_ERROR_OF_MEAN|2.75||0.7272|TWO_SIDED|95.0|-4.45|6.37|||Mixed Models Analysis|||Month 36 Pain Intensity Total Converted Score||6.37|-4.45|0.7272
72367708|NCT00658359|144245353|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.17|STANDARD_ERROR_OF_MEAN|0.71||0.8111|TWO_SIDED|95.0|-1.56|1.22|||Mixed Models Analysis|||Month 36 Non-Pain symptoms Converted Score||1.22|-1.56|0.8111
72367709|NCT00658359|144245353|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.14|STANDARD_ERROR_OF_MEAN|1.02||0.2636|TWO_SIDED|95.0|-0.86|3.13|||Mixed Models Analysis|||Month 36 Non-Pain Symptoms Converted Score||3.13|-0.86|0.2636
72367710|NCT00658359|144245353|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.45|STANDARD_ERROR_OF_MEAN|1.13||0.689|TWO_SIDED|95.0|-1.77|2.67|||Mixed Models Analysis|||Month 36 Satisfaction Converted Score||2.67|-1.77|0.6890
72367711|NCT00658359|144245353|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.13|STANDARD_ERROR_OF_MEAN|1.62||0.4853|TWO_SIDED|95.0|-4.31|2.05|||Mixed Models Analysis|||Month 36 Satisfaction Converted Score||2.05|-4.31|0.4853
72367712|NCT02754440|144245356|OTHER|A procedure is a success if the subject's platelet product has a residual WBC count of \< 5.0 × 10\^6 for the single platelet product group. The FDA requirements are met if the lower one-sided 95% confidence interval for the procedure success rate is at least 95%.|Simple Sample Proportion|1.0|STANDARD_ERROR_OF_MEAN|0.0|||ONE_SIDED|95.0|0.968||||||When estimated proportion is 100%, standard error of the mean is estimated as 0.|Up to 450 healthy adult subjects will be enrolled in this study to ensure 93 evaluable single platelet product collections, 93 evaluable double platelet product collections, and 93 evaluable triple platelet product collections. This number was chosen to meet the FDA requirements of at least 95% of platelet units with an acceptable residual WBC level with 95% confidence. With 93 platelet products, this allowed for at most 1 failure.|||0.968|
72367713|NCT02754440|144245356|OTHER|A procedure is a success if the subject's platelet product has a residual WBC count of \< 8.0 × 10\^6 for the double platelet product group, or \< 5.0 × 10\^6 for each transfusable unit . The FDA requirements are met if the lower one-sided 95% confidence interval for the procedure success rate is at least 95%.|Simple Sample Proportion|1.0|STANDARD_ERROR_OF_MEAN|0.0|||ONE_SIDED|95.0|0.968||||||When estimated proportion is 100%, standard error of the mean is estimated as 0.|Up to 450 healthy adult subjects will be enrolled in this study to ensure 93 evaluable single platelet product collections, 93 evaluable double platelet product collections, and 93 evaluable triple platelet product collections. This number was chosen to meet the FDA requirements of at least 95% of platelet units with an acceptable residual WBC level with 95% confidence. With 93 platelet products, this allowed for at most 1 failure.|||0.968|
72367714|NCT02754440|144245356|OTHER|A procedure is a success if the subject's platelet product has a residual WBC count of \< 12.0 × 10\^6 for the triple platelet product group, or \< 5.0 × 10\^6 for each transfusable unit . The FDA requirements are met if the lower one-sided 95% confidence interval for the procedure success rate is at least 95%.|Simple Sample Proportion|1.0|STANDARD_ERROR_OF_MEAN|0.0|||ONE_SIDED|95.0|0.968||||||When estimated proportion is 100%, standard error of the mean is estimated as 0.|Up to 450 healthy adult subjects will be enrolled in this study to ensure 93 evaluable single platelet product collections, 93 evaluable double platelet product collections, and 93 evaluable triple platelet product collections. This number was chosen to meet the FDA requirements of at least 95% of platelet units with an acceptable residual WBC level with 95% confidence. With 93 platelet products, this allowed for at most 1 failure.|||0.968|
72367715|NCT02754440|144245357|OTHER|A procedure is a success if the subject's platelet product has a platelet yield of ≥ 3.0 × 10\^11 for the single platelet product group. The requirements are met if the lower one-sided 95% confidence interval for the procedure success rate is at least 75%.|Simple Sample Proportion|0.957|STANDARD_ERROR_OF_MEAN|0.021|||ONE_SIDED|95.0|0.904|||||||Up to 450 healthy subjects were enrolled to ensure 93 evaluable single, double, and triple platelet product collections. With 93 platelet products being collected, 16 failures or less was required to show that the proportion of units with an acceptable platelet yield is at least 75% with 95% confidence.|||0.904|
72367716|NCT02754440|144245357|OTHER|A procedure is a success if the subject's platelet product has a platelet yield of ≥ 6.2 × 10\^11 for the double platelet product group. The requirements are met if the lower one-sided 95% confidence interval for the procedure success rate is at least 75%.|Simple Sample Proportion|1.0|STANDARD_ERROR_OF_MEAN|0.0|||ONE_SIDED|95.0|0.968||||||When estimated proportion is 100%, standard error of the mean is estimated as 0.|Up to 450 healthy subjects were enrolled to ensure 93 evaluable single, double, and triple platelet product collections. With 93 platelet products being collected, 16 failures or less was required to show that the proportion of units with an acceptable platelet yield is at least 75% with 95% confidence.|||0.968|
72367717|NCT02754440|144245357|OTHER|A procedure is a success if the subject's platelet product has a platelet yield of ≥ 9.3 × 10\^11 for the triple platelet product group. The requirements are met if the lower one-sided 95% confidence interval for the procedure success rate is at least 75%.|Simple Sample Proportion|1.0|STANDARD_ERROR_OF_MEAN|0.0|||ONE_SIDED|95.0|0.968||||||When estimated proportion is 100%, standard error of the mean is estimated as 0.|Up to 450 healthy subjects were enrolled to ensure 93 evaluable single, double, and triple platelet product collections. With 93 platelet products being collected, 16 failures or less was required to show that the proportion of units with an acceptable platelet yield is at least 75% with 95% confidence.|||0.968|
72367718|NCT01263197|144245393|SUPERIORITY_OR_OTHER||LS mean difference|2.27|||||TWO_SIDED|95.0|-3.96|8.49||||||Difference of LS means (test minus reference) for the maximum changes in heart rate on Day 1, where test is the LY2216684+albuterol treatment arm and reference is the LY2216684 (Group 1) treatment arm.||8.49|-3.96|
72367719|NCT01263197|144245393|SUPERIORITY_OR_OTHER||LS mean difference|0.198|||||TWO_SIDED|95.0|-3.19|3.59||||||Difference of LS means (test minus reference) for the minimum changes in heart rate on Day 1, where test is the LY2216684+albuterol treatment arm and reference is the LY2216684 (Group 1) treatment arm.||3.59|-3.19|
72367720|NCT01263197|144245393|SUPERIORITY_OR_OTHER||LS mean difference|1.55|||||TWO_SIDED|95.0|-2.25|5.35||||||Difference of LS means (test minus reference) for the average changes in heart rate on Day 1, where test is the LY2216684+albuterol treatment arm and reference is the LY2216684 (Group 1) treatment arm.||5.35|-2.25|
72367721|NCT01263197|144245393|SUPERIORITY_OR_OTHER||LS mean difference|20.0|||||TWO_SIDED|95.0|13.7|26.2||||||Difference of LS means (test minus reference) for the maximum changes in heart rate on Day 1, where test is the LY2216684+albuterol treatment arm and reference is the albuterol treatment arm.||26.2|13.7|
72367722|NCT01263197|144245393|SUPERIORITY_OR_OTHER||LS mean difference|6.19|||||TWO_SIDED|95.0|2.8|9.58||||||Difference of LS means (test minus reference) for the minimum changes in heart rate on Day 1, where test is the LY2216684+albuterol treatment arm and reference is the albuterol treatment arm.||9.58|2.80|
72367723|NCT01263197|144245393|SUPERIORITY_OR_OTHER||LS mean difference|11.7|||||TWO_SIDED|95.0|7.87|15.5||||||Difference of LS means (test minus reference) for the average changes in heart rate on Day 1, where test is the LY2216684+albuterol treatment arm and reference is the albuterol treatment arm.||15.5|7.87|
72367724|NCT01263197|144245393|SUPERIORITY_OR_OTHER||LS mean difference|-13.9|||||TWO_SIDED|95.0|-18.9|-8.8||||||Difference of LS means (test minus reference) for the maximum changes in heart rate on Day 1, where test is the LY2216684+propranolol treatment arm and reference is the LY2216684 (Group 2) treatment arm.||-8.80|-18.9|
72367725|NCT01263197|144245393|SUPERIORITY_OR_OTHER||LS mean difference|-4.62|||||TWO_SIDED|95.0|-7.67|-1.56||||||Difference of LS means (test minus reference) for the minimum changes in heart rate on Day 1, where test is the LY2216684+propranolol treatment arm and reference is the LY2216684 (Group 2) treatment arm.||-1.56|-7.67|
72367726|NCT01263197|144245393|SUPERIORITY_OR_OTHER||LS mean difference|-8.43|||||TWO_SIDED|95.0|-11.5|-5.33||||||Difference of LS means (test minus reference) for the average changes in heart rate on Day 1, where test is the LY2216684+propranolol treatment arm and reference is the LY2216684 (Group 2) treatment arm.||-5.33|-11.5|
72367727|NCT01263197|144245393|SUPERIORITY_OR_OTHER||LS mean difference|7.8|||||TWO_SIDED|95.0|2.72|12.9||||||Difference of LS means (test minus reference) for the maximum changes in heart rate on Day 1, where test is the LY2216684+propranolol treatment arm and reference is the propranolol treatment arm.||12.9|2.72|
72367728|NCT01263197|144245393|SUPERIORITY_OR_OTHER||LS mean difference|4.38|||||TWO_SIDED|95.0|1.3|7.46||||||Difference of LS means (test minus reference) for the minimum changes in heart rate on Day 1, where test is the LY2216684+propranolol treatment arm and reference is the propranolol treatment arm.||7.46|1.30|
72367729|NCT01263197|144245393|SUPERIORITY_OR_OTHER||LS mean difference|5.06|||||TWO_SIDED|95.0|1.93|8.18||||||Difference of LS means (test minus reference) for the average changes in heart rate on Day 1, where test is the LY2216684+propranolol treatment arm and reference is the propranolol treatment arm.||8.18|1.93|
72367730|NCT01263197|144245393|SUPERIORITY_OR_OTHER||LS mean difference|0.905|||||TWO_SIDED|95.0|-5.49|7.3||||||Difference of LS means (test minus reference) for the maximum changes in heart rate on Day 3 where test is the LY2216684+albuterol treatment arm and reference is the LY2216684 (Group 1) treatment arm.||7.30|-5.49|
72367731|NCT01263197|144245393|SUPERIORITY_OR_OTHER||LS mean difference|-2.71|||||TWO_SIDED|95.0|-6.96|1.54||||||Difference of LS means (test minus reference) for the minimum changes in heart rate on Day 3 where test is the LY2216684+albuterol treatment arm and reference is the LY2216684 (Group 1) treatment arm.||1.54|-6.96|
72367732|NCT01263197|144245393|SUPERIORITY_OR_OTHER||LS mean difference|1.66|||||TWO_SIDED|95.0|-2.85|6.16||||||Difference of LS means (test minus reference) for the average changes in heart rate on Day 3, where test is the LY2216684+albuterol treatment arm and reference is the LY2216684 (Group 1) treatment arm.||6.16|-2.85|
72367733|NCT01263197|144245393|SUPERIORITY_OR_OTHER||LS mean difference|17.5|||||TWO_SIDED|95.0|11.2|23.8||||||Difference of LS means (test minus reference) for the maximum changes in heart rate on Day 3 where test is the LY2216684+albuterol treatment arm and reference is the albuterol treatment arm.||23.8|11.2|
72367734|NCT01263197|144245393|SUPERIORITY_OR_OTHER||LS mean difference|6.51|||||TWO_SIDED|95.0|2.32|10.7||||||Difference of LS means (test minus reference) for the minimum changes in heart rate on Day 3, where test is the LY2216684+albuterol treatment arm and reference is the albuterol treatment arm.||10.7|2.32|
72367735|NCT01263197|144245393|SUPERIORITY_OR_OTHER||LS mean difference|14.2|||||TWO_SIDED|95.0|9.75|18.7||||||Difference of LS means (test minus reference) for the average changes in heart rate on Day 3, where test is the LY2216684+albuterol treatment arm and reference is the albuterol treatment arm.||18.7|9.75|
72367736|NCT01263197|144245393|SUPERIORITY_OR_OTHER||LS mean difference|-9.98|||||TWO_SIDED|95.0|-14.6|-5.34||||||Difference of LS means (test minus reference) for the maximum changes in heart rate on Day 3, where test is the LY2216684+propranolol treatment arm and reference is the LY2216684 (Group 2) treatment arm.||-5.34|-14.6|
72367737|NCT01263197|144245393|SUPERIORITY_OR_OTHER||LS mean difference|-3.46|||||TWO_SIDED|95.0|-7.22|0.297||||||Difference of LS means (test minus reference) for the minimum changes in heart rate on Day 3, where test is the LY2216684+propranolol treatment arm and reference is the LY2216684 (Group 2) treatment arm.||0.297|-7.22|
72367738|NCT01263197|144245393|SUPERIORITY_OR_OTHER||LS mean difference|-8.16|||||TWO_SIDED|95.0|-11.6|-4.71||||||Difference of LS means (test minus reference) for the average changes in heart rate on Day 3, where test is the LY2216684+propranolol treatment arm and reference is the LY2216684 (Group 2) treatment arm.||-4.71|-11.6|
72367739|NCT01263197|144245393|SUPERIORITY_OR_OTHER||LS mean difference|12.1|||||TWO_SIDED|95.0|7.39|16.8||||||Difference of LS means (test minus reference) for the maximum changes in heart rate on Day 3, where test is the LY2216684+propranolol treatment arm and reference is the propranolol treatment arm.||16.8|7.39|
72367740|NCT01263197|144245393|SUPERIORITY_OR_OTHER||LS mean difference|6.7|||||TWO_SIDED|95.0|2.91|10.5||||||Difference of LS means (test minus reference) for the minimum changes in heart rate on Day 3, where test is the LY2216684+propranolol treatment arm and reference is the propranolol treatment arm.||10.5|2.91|
72367741|NCT01263197|144245393|SUPERIORITY_OR_OTHER||LS mean difference|10.3|||||TWO_SIDED|95.0|6.88|13.8||||||Difference of LS means (test minus reference) for the average changes in heart rate on Day 3, where test is the LY2216684+propranolol treatment arm and reference is the propranolol treatment arm.||13.8|6.88|
72367742|NCT01263197|144245393|SUPERIORITY_OR_OTHER||LS mean difference|-1.06|||||TWO_SIDED|95.0|-7.41|5.3||||||Difference of LS means (test minus reference) for the maximum changes in heart rate on Day 5, where test is the LY2216684+albuterol treatment arm and reference is the LY2216684 (Group 1) treatment arm.||5.30|-7.41|
72367743|NCT01263197|144245393|SUPERIORITY_OR_OTHER||LS mean difference|2.2|||||TWO_SIDED|95.0|-2.15|6.56||||||Difference of LS means (test minus reference) for the minimum changes in heart rate on Day 5, where test is the LY2216684+albuterol treatment arm and reference is the LY2216684 (Group 1) treatment arm.||6.56|-2.15|
72367744|NCT01263197|144245393|SUPERIORITY_OR_OTHER||LS mean difference|1.12|||||TWO_SIDED|95.0|-3.23|5.47||||||Difference of LS means (test minus reference) for the average changes in heart rate on Day 5, where test is the LY2216684+albuterol treatment arm and reference is the LY2216684 (Group 1) treatment arm.||5.47|-3.23|
72367745|NCT01263197|144245393|SUPERIORITY_OR_OTHER||LS mean difference|19.4|||||TWO_SIDED|95.0|13.2|25.6||||||Difference of LS means (test minus reference) for the maximum changes in heart rate on Day 5 where test is the LY2216684+albuterol treatment arm and reference is the albuterol treatment arm.||25.6|13.2|
72367746|NCT01263197|144245393|SUPERIORITY_OR_OTHER||LS mean difference|9.04|||||TWO_SIDED|95.0|4.78|13.3||||||Difference of LS means (test minus reference) for the minimum changes in heart rate on Day 5 where test is the LY2216684+albuterol treatment arm and reference is the albuterol treatment arm.||13.3|4.78|
72367747|NCT01263197|144245393|SUPERIORITY_OR_OTHER||LS mean difference|14.7|||||TWO_SIDED|95.0|10.4|18.9||||||Difference of LS means (test minus reference) for the average changes in heart rate on Day 5, where test is the LY2216684+albuterol treatment arm and reference is the albuterol treatment arm.||18.9|10.4|
72367748|NCT01263197|144245393|SUPERIORITY_OR_OTHER||LS mean difference|-10.6|||||TWO_SIDED|95.0|-15.6|-5.52||||||Difference of LS means (test minus reference) for the maximum changes in heart rate on Day 5, where test is the LY2216684+propranolol treatment arm and reference is the LY2216684 (Group 2) treatment arm.||-5.52|-15.6|
72367749|NCT01263197|144245393|SUPERIORITY_OR_OTHER||LS mean difference|-4.25|||||TWO_SIDED|95.0|-9.26|0.764||||||Difference of LS means (test minus reference) for the minimum changes in heart rate on Day 5, where test is the LY2216684+propranolol treatment arm and reference is the LY2216684 (Group 2) treatment arm.||0.764|-9.26|
72367750|NCT01263197|144245393|SUPERIORITY_OR_OTHER||LS mean difference|-8.76|||||TWO_SIDED|95.0|-12.6|-4.87||||||Difference of LS means (test minus reference) for the average changes in heart rate on Day 5, where test is the LY2216684+propranolol treatment arm and reference is the LY2216684 (Group 2) treatment arm.||-4.87|-12.6|
72367751|NCT01263197|144245393|SUPERIORITY_OR_OTHER||LS mean difference|12.3|||||TWO_SIDED|95.0|7.17|17.4||||||Difference of LS means (test minus reference) for the maximum changes in heart rate on Day 5, where test is the LY2216684+propranolol treatment arm and reference is the propranolol treatment arm.||17.4|7.17|
72367752|NCT01263197|144245393|SUPERIORITY_OR_OTHER||LS mean difference|5.95|||||TWO_SIDED|95.0|0.917|11.0||||||Difference of LS means (test minus reference) for the minimum changes in heart rate on Day 5, where test is the LY2216684+propranolol treatment arm and reference is the propranolol treatment arm.||11.0|0.917|
72367753|NCT01263197|144245393|SUPERIORITY_OR_OTHER||LS mean difference|9.9|||||TWO_SIDED|95.0|5.98|13.8||||||Difference of LS means (test minus reference) for the average changes in heart rate on Day 5, where test is the LY2216684+propranolol treatment arm and reference is the propranolol treatment arm.||13.8|5.98|
72367754|NCT01263197|144245394|SUPERIORITY_OR_OTHER||LS mean difference|1.62|||||TWO_SIDED|95.0|-1.81|5.06||||||Difference of LS means (test minus reference) for the maximum changes in systolic blood pressure on Day 1, where test is the LY2216684+albuterol treatment arm and reference is the LY2216684 (Group 1) treatment arm.||5.06|-1.81|
72367755|NCT01263197|144245394|SUPERIORITY_OR_OTHER||LS mean difference|2.73|||||TWO_SIDED|95.0|-1.38|6.85||||||Difference of LS means (test minus reference) for the minimum changes in systolic blood pressure on Day 1, where test is the LY2216684+albuterol treatment arm and reference is the LY2216684 (Group 1) treatment arm.||6.85|-1.38|
72367756|NCT01263197|144245394|SUPERIORITY_OR_OTHER||LS mean difference|2.67|||||TWO_SIDED|95.0|-0.209|5.56||||||Difference of LS means (test minus reference) for the average changes in systolic blood pressure on Day 1, where test is the LY2216684+albuterol treatment arm and reference is the LY2216684 (Group 1) treatment arm.||5.56|-0.209|
72367757|NCT01263197|144245394|SUPERIORITY_OR_OTHER||LS mean difference|0.541|||||TWO_SIDED|95.0|-2.94|4.02||||||Difference of LS means (test minus reference) for the maximum changes in systolic blood pressure on Day 1, where test is the LY2216684+albuterol treatment arm and reference is the albuterol treatment arm.||4.02|-2.94|
72367758|NCT01263197|144245394|SUPERIORITY_OR_OTHER||LS mean difference|5.26|||||TWO_SIDED|95.0|1.09|9.43||||||Difference of LS means (test minus reference) for the minimum changes in systolic blood pressure on Day 1, where test is the LY2216684+albuterol treatment arm and reference is the albuterol treatment arm.||9.43|1.09|
72367759|NCT01263197|144245394|SUPERIORITY_OR_OTHER||LS mean difference|2.6|||||TWO_SIDED|95.0|-0.322|5.52||||||Difference of LS means (test minus reference) for the average changes in systolic blood pressure on Day 1, where test is the LY2216684+albuterol treatment arm and reference is the albuterol treatment arm.||5.52|-0.322|
72367760|NCT01263197|144245394|SUPERIORITY_OR_OTHER||LS mean difference|-6.46|||||TWO_SIDED|95.0|-11.5|-1.41||||||Difference of LS means (test minus reference) for the maximum changes in systolic blood pressure on Day 1, where test is the LY2216684+propranolol treatment arm and reference is the LY2216684 (Group 2) treatment arm.||-1.41|-11.5|
72367761|NCT01263197|144245394|SUPERIORITY_OR_OTHER||LS mean difference|0.171|||||TWO_SIDED|95.0|-5.21|5.56||||||Difference of LS means (test minus reference) for the minimum changes in systolic blood pressure on Day 1, where test is the LY2216684+propranolol treatment arm and reference is the LY2216684 (Group 2) treatment arm.||5.56|-5.21|
72367762|NCT01263197|144245394|SUPERIORITY_OR_OTHER||LS mean difference|-3.09|||||TWO_SIDED|95.0|-6.73|0.557||||||Difference of LS means (test minus reference) for the average changes in systolic blood pressure on Day 1, where test is the LY2216684+propranolol treatment arm and reference is the LY2216684 (Group 2) treatment arm.||0.557|-6.73|
72367763|NCT01263197|144245394|SUPERIORITY_OR_OTHER||LS mean difference|1.46|||||TWO_SIDED|95.0|-3.61|6.53||||||Difference of LS means (test minus reference) for the maximum changes in systolic blood pressure on Day 1, where test is the LY2216684+propranolol treatment arm and reference is the propranolol treatment arm.||6.53|-3.61|
72367764|NCT01263197|144245394|SUPERIORITY_OR_OTHER||LS mean difference|11.4|||||TWO_SIDED|95.0|5.99|16.8||||||Difference of LS means (test minus reference) for the minimum changes in systolic blood pressure on Day 1, where test is the LY2216684+propranolol treatment arm and reference is the propranolol treatment arm.||16.8|5.99|
72367765|NCT01263197|144245394|SUPERIORITY_OR_OTHER||LS mean difference|7.15|||||TWO_SIDED|95.0|3.49|10.8||||||Difference of LS means (test minus reference) for the average changes in systolic blood pressure on Day 1, where test is the LY2216684+propranolol treatment arm and reference is the propranolol treatment arm.||10.8|3.49|
72553285|NCT01077596|144637887|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|0.9||||||95.0|0.8|1.1|||||Adjusted for age, sex, cal year, study site, tumor characteristics, multiple antidepressants exposure, smoking, hysterectomy status, previous depression dx, previous IBD diagnosis, OC use, HRT/ERT use, and NSAID use.|||1.1|0.8|
72553286|NCT01077596|144637887|SUPERIORITY_OR_OTHER||Crude Odds Ratio|1.1||||||95.0|0.9|1.3||||||||1.3|0.9|
72553287|NCT01077596|144637887|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.1||||||95.0|0.9|1.2|||||Adjusted for age, sex, cal year, study site, tumor characteristics, multiple antidepressants exposure, smoking, hysterectomy status, previous depression dx, previous IBD diagnosis, OC use, HRT/ERT use, and NSAID use.|||1.2|0.9|
72553288|NCT01077596|144637888|SUPERIORITY_OR_OTHER||Crude Odds Ratio|1.1||||||95.0|1.0|1.3||||||||1.3|1.0|
72553289|NCT01077596|144637888|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.2||||||95.0|1.0|1.3|||||Adjusted for age, sex, cal year, study site, tumor characteristics, multiple antidepressants exposure, smoking, hysterectomy status, previous depression dx, previous IBD diagnosis, OC use, HRT/ERT use, and NSAID use.|||1.3|1.0|
72553290|NCT01077596|144637888|SUPERIORITY_OR_OTHER||Crude Odds Ratio|1.2||||||95.0|1.0|1.4||||||||1.4|1.0|
72553291|NCT01077596|144637888|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.2||||||95.0|1.0|1.4|||||Adjusted for age, sex, cal year, study site, tumor characteristics, multiple antidepressants exposure, smoking, hysterectomy status, previous depression dx, previous IBD diagnosis, OC use, HRT/ERT use, and NSAID use.|||1.4|1.0|
72553292|NCT01077596|144637888|SUPERIORITY_OR_OTHER||Crude Odds Ratio|1.1||||||95.0|0.9|1.2||||||||1.2|0.9|
72553293|NCT01077596|144637888|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.1||||||95.0|0.9|1.3|||||Adjusted for age, sex, cal year, study site, tumor characteristics, multiple antidepressants exposure, smoking, hysterectomy status, previous depression dx, previous IBD diagnosis, OC use, HRT/ERT use, and NSAID use.|||1.3|0.9|
72553294|NCT01077596|144637888|SUPERIORITY_OR_OTHER||Crude Odds Ratio|1.0||||||95.0|0.9|1.2||||||||1.2|0.9|
72553295|NCT01077596|144637888|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.0||||||95.0|0.8|1.2|||||Adjusted for age, sex, cal year, study site, tumor characteristics, multiple antidepressants exposure, smoking, hysterectomy status, previous depression dx, previous IBD diagnosis, OC use, HRT/ERT use, and NSAID use.|||1.2|0.8|
72553296|NCT02024932|144637910|SUPERIORITY_OR_OTHER_LEGACY||Geo-mean ratio|1.037||||0.0164|TWO_SIDED|90.0|1.009|1.065|||ANCOVA|||||1.065|1.009|0.0164
72553297|NCT01149473|144637973|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|109.0|||||TWO_SIDED|90.0|98.1|120.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||120|98.1|
72553298|NCT01149473|144637974|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|102.0|||||TWO_SIDED|90.0|98.8|106.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||106|98.8|
72553299|NCT01149473|144637975|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|101.0|||||TWO_SIDED|90.0|98.6|104.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||104|98.6|
72553300|NCT01149473|144637976|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|103.0|||||TWO_SIDED|90.0|98.8|108.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||108|98.8|
72553301|NCT01149473|144637977|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|99.7|||||TWO_SIDED|95.0|98.6|101.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||101|98.6|
72553302|NCT01149473|144637978|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|99.7|||||TWO_SIDED|90.0|98.7|101.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||101|98.7|
72553303|NCT00834067|144638036|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|96.7||||||90.0|90.1|104.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||104|90.1|
72367766|NCT01263197|144245394|SUPERIORITY_OR_OTHER||LS mean difference|0.0309|||||TWO_SIDED|95.0|-5.28|5.34||||||Difference of LS means (test minus reference) for the maximum changes in systolic blood pressure on Day 3, where test is the LY2216684+albuterol treatment arm and reference is the LY2216684 (Group 1) treatment arm.||5.34|-5.28|
72367767|NCT01263197|144245394|SUPERIORITY_OR_OTHER||LS mean difference|-1.17|||||TWO_SIDED|95.0|-5.93|3.59||||||Difference of LS means (test minus reference) for the minimum changes in systolic blood pressure on Day 3, where test is the LY2216684+albuterol treatment arm and reference is the LY2216684 (Group 1) treatment arm.||3.59|-5.93|
72367768|NCT01263197|144245394|SUPERIORITY_OR_OTHER||LS mean difference|-0.333|||||TWO_SIDED|95.0|-4.35|3.68||||||Difference of LS means (test minus reference) for the average changes in systolic blood pressure on Day 3, where test is the LY2216684+albuterol treatment arm and reference is the LY2216684 (Group 1) treatment arm.||3.68|-4.35|
72367769|NCT01263197|144245394|SUPERIORITY_OR_OTHER||LS mean difference|-2.11|||||TWO_SIDED|95.0|-7.42|3.2||||||Difference of LS means (test minus reference) for the maximum changes in systolic blood pressure on Day 3, where test is the LY2216684+albuterol treatment arm and reference is the albuterol treatment arm.||3.20|-7.42|
72367770|NCT01263197|144245394|SUPERIORITY_OR_OTHER||LS mean difference|4.36|||||TWO_SIDED|95.0|-0.404|9.12||||||Difference of LS means (test minus reference) for the minimum changes in systolic blood pressure on Day 3, where test is the LY2216684+albuterol treatment arm and reference is the albuterol treatment arm.||9.12|-0.404|
72367771|NCT01263197|144245394|SUPERIORITY_OR_OTHER||LS mean difference|-0.119|||||TWO_SIDED|95.0|-4.14|3.9||||||Difference of LS means (test minus reference) for the average changes in systolic blood pressure on Day 3, where test is the LY2216684+albuterol treatment arm and reference is the albuterol treatment arm.||3.90|-4.14|
72367772|NCT01263197|144245394|SUPERIORITY_OR_OTHER||LS mean difference|-4.16|||||TWO_SIDED|95.0|-9.69|1.37||||||Difference of LS means (test minus reference) for the maximum changes in systolic blood pressure on Day 3, where test is the LY2216684+propranolol treatment arm and reference is the LY2216684 (Group 2) treatment arm.||1.37|-9.69|
72367773|NCT01263197|144245394|SUPERIORITY_OR_OTHER||LS mean difference|-4.76|||||TWO_SIDED|95.0|-10.2|0.718||||||Difference of LS means (test minus reference) for the minimum changes in systolic blood pressure on Day 3, where test is the LY2216684+propranolol treatment arm and reference is the LY2216684 (Group 2) treatment arm.||0.718|-10.2|
72367774|NCT01263197|144245394|SUPERIORITY_OR_OTHER||LS mean difference|-4.2|||||TWO_SIDED|95.0|-8.71|0.32||||||Difference of LS means (test minus reference) for the average changes in systolic blood pressure on Day 3, where test is the LY2216684+propranolol treatment arm and reference is the LY2216684 (Group 2) treatment arm.||0.320|-8.71|
72367775|NCT01263197|144245394|SUPERIORITY_OR_OTHER||LS mean difference|3.2|||||TWO_SIDED|95.0|-2.34|8.74||||||Difference of LS means (test minus reference) for the maximum changes in systolic blood pressure on Day 3, where test is the LY2216684+propranolol treatment arm and reference is the propranolol treatment arm.||8.74|-2.34|
72367776|NCT01263197|144245394|SUPERIORITY_OR_OTHER||LS mean difference|3.95|||||TWO_SIDED|95.0|-1.54|9.43||||||Difference of LS means (test minus reference) for the minimum changes in systolic blood pressure on Day 3, where test is the LY2216684+propranolol treatment arm and reference is the propranolol treatment arm.||9.43|-1.54|
72367777|NCT01263197|144245394|SUPERIORITY_OR_OTHER||LS mean difference|4.84|||||TWO_SIDED|95.0|0.319|9.37||||||Difference of LS means (test minus reference) for the average changes in systolic blood pressure on Day 3, where test is the LY2216684+propranolol treatment arm and reference is the propranolol treatment arm.||9.37|0.319|
72367778|NCT01263197|144245394|SUPERIORITY_OR_OTHER||LS mean difference|2.34|||||TWO_SIDED|95.0|-3.44|8.12||||||Difference of LS means (test minus reference) for the maximum changes in systolic blood pressure on Day 5, where test is the LY2216684+albuterol treatment arm and reference is the LY2216684 (Group 1) treatment arm.||8.12|-3.44|
72367779|NCT01263197|144245394|SUPERIORITY_OR_OTHER||LS mean difference|1.89|||||TWO_SIDED|95.0|-3.22|7.0||||||Difference of LS means (test minus reference) for the minimum changes in systolic blood pressure on Day 5, where test is the LY2216684+albuterol treatment arm and reference is the LY2216684 (Group 1) treatment arm.||7.00|-3.22|
72367780|NCT01263197|144245394|SUPERIORITY_OR_OTHER||LS mean difference|1.83|||||TWO_SIDED|95.0|-1.85|5.52||||||Difference of LS means (test minus reference) for the average changes in systolic blood pressure on Day 5, where test is the LY2216684+albuterol treatment arm and reference is the LY2216684 (Group 1) treatment arm.||5.52|-1.85|
72367781|NCT01263197|144245394|SUPERIORITY_OR_OTHER||LS mean difference|0.327|||||TWO_SIDED|95.0|-5.45|6.1||||||Difference of LS means (test minus reference) for the maximum changes in systolic blood pressure on Day 5, where test is the LY2216684+albuterol treatment arm and reference is the albuterol treatment arm.||6.10|-5.45|
72367782|NCT01263197|144245394|SUPERIORITY_OR_OTHER||LS mean difference|3.18|||||TWO_SIDED|95.0|-1.93|8.29||||||Difference of LS means (test minus reference) for the minimum changes in systolic blood pressure on Day 5, where test is the LY2216684+albuterol treatment arm and reference is the albuterol treatment arm.||8.29|-1.93|
72367783|NCT01263197|144245394|SUPERIORITY_OR_OTHER||LS mean difference|2.12|||||TWO_SIDED|95.0|-1.56|5.81||||||Difference of LS means (test minus reference) for the average changes in systolic blood pressure on Day 5, where test is the LY2216684+albuterol treatment arm and reference is the albuterol treatment arm.||5.81|-1.56|
72367784|NCT01263197|144245394|SUPERIORITY_OR_OTHER||LS mean difference|-1.6|||||TWO_SIDED|95.0|-6.79|3.59||||||Difference of LS means (test minus reference) for the maximum changes in systolic blood pressure on Day 5, where test is the LY2216684+propranolol treatment arm and reference is the LY2216684 (Group 2) treatment arm.||3.59|-6.79|
72367785|NCT01263197|144245394|SUPERIORITY_OR_OTHER||LS mean difference|-0.163|||||TWO_SIDED|95.0|-5.0|4.68||||||Difference of LS means (test minus reference) for the minimum changes in systolic blood pressure on Day 5, where test is the LY2216684+propranolol treatment arm and reference is the LY2216684 (Group 2) treatment arm.||4.68|-5.00|
72367786|NCT01263197|144245394|SUPERIORITY_OR_OTHER||LS mean difference|-0.829|||||TWO_SIDED|95.0|-5.2|3.54||||||Difference of LS means (test minus reference) for the average changes in systolic blood pressure on Day 5, where test is the LY2216684+propranolol treatment arm and reference is the LY2216684 (Group 2) treatment arm.||3.54|-5.20|
72367787|NCT01263197|144245394|SUPERIORITY_OR_OTHER||LS mean difference|1.95|||||TWO_SIDED|95.0|-3.27|7.17||||||Difference of LS means (test minus reference) for the maximum changes in systolic blood pressure on Day 5, where test is the LY2216684+propranolol treatment arm and reference is the propranolol treatment arm.||7.17|-3.27|
72367788|NCT01263197|144245394|SUPERIORITY_OR_OTHER||LS mean difference|3.71|||||TWO_SIDED|95.0|-1.17|8.59||||||Difference of LS means (test minus reference) for the minimum changes in systolic blood pressure on Day 5, where test is the LY2216684+propranolol treatment arm and reference is the propranolol treatment arm.||8.59|-1.17|
72367789|NCT01263197|144245394|SUPERIORITY_OR_OTHER||LS mean difference|4.28|||||TWO_SIDED|95.0|-0.103|8.67||||||Difference of LS means (test minus reference) for the average changes in systolic blood pressure on Day 5, where test is the LY2216684+propranolol treatment arm and reference is the propranolol treatment arm.||8.67|-0.103|
72367790|NCT01263197|144245395|SUPERIORITY_OR_OTHER||LS mean difference|-1.23|||||TWO_SIDED|95.0|-3.9|1.44||||||Difference of LS means (test minus reference) for the maximum changes in diastolic blood pressure on Day 1, where test is the LY2216684+albuterol treatment arm and reference is the LY2216684 (Group 1) treatment arm.||1.44|-3.90|
72367791|NCT01263197|144245395|SUPERIORITY_OR_OTHER||LS mean difference|1.05|||||TWO_SIDED|95.0|-1.91|4.02||||||Difference of LS means (test minus reference) for the minimum changes in diastolic blood pressure on Day 1, where test is the LY2216684+albuterol treatment arm and reference is the LY2216684 (Group 1) treatment arm.||4.02|-1.91|
72367792|NCT01263197|144245395|SUPERIORITY_OR_OTHER||LS mean difference|-0.199|||||TWO_SIDED|95.0|-2.58|2.18||||||Difference of LS means (test minus reference) for the average changes in diastolic blood pressure on Day 1, where test is the LY2216684+albuterol treatment arm and reference is the LY2216684 (Group 1) treatment arm.||2.18|-2.58|
72367793|NCT01263197|144245395|SUPERIORITY_OR_OTHER||LS mean difference|1.37|||||TWO_SIDED|95.0|-1.34|4.07||||||Difference of LS means (test minus reference) for the maximum changes in diastolic blood pressure on Day 1, where test is the LY2216684+albuterol treatment arm and reference is the albuterol treatment arm.||4.07|-1.34|
72367794|NCT01263197|144245395|SUPERIORITY_OR_OTHER||LS mean difference|3.68|||||TWO_SIDED|95.0|0.674|6.69||||||Difference of LS means (test minus reference) for the minimum changes in diastolic blood pressure on Day 1, where test is the LY2216684+albuterol treatment arm and reference is the albuterol treatment arm.||6.69|0.674|
72367795|NCT01263197|144245395|SUPERIORITY_OR_OTHER||LS mean difference|2.4|||||TWO_SIDED|95.0|-0.0178|4.81||||||Difference of LS means (test minus reference) for the average changes in diastolic blood pressure on Day 1, where test is the LY2216684+albuterol treatment arm and reference is the albuterol treatment arm.||4.81|-0.0178|
72367796|NCT01263197|144245395|SUPERIORITY_OR_OTHER||LS mean difference|-4.22|||||TWO_SIDED|95.0|-7.83|-0.619||||||Difference of LS means (test minus reference) for the maximum changes in diastolic blood pressure on Day 1, where test is the LY2216684+propranolol treatment arm and reference is the LY2216684 (Group 2) treatment arm.||-0.619|-7.83|
72367797|NCT01263197|144245395|SUPERIORITY_OR_OTHER||LS mean difference|0.335|||||TWO_SIDED|95.0|-4.45|5.12||||||Difference of LS means (test minus reference) for the minimum changes in diastolic blood pressure on Day 1, where test is the LY2216684+propranolol treatment arm and reference is the LY2216684 (Group 2) treatment arm.||5.12|-4.45|
72367798|NCT01263197|144245395|SUPERIORITY_OR_OTHER||LS mean difference|-1.92|||||TWO_SIDED|95.0|-4.81|0.969||||||Difference of LS means (test minus reference) for the average changes in diastolic blood pressure on Day 1, where test is the LY2216684+propranolol treatment arm and reference is the LY2216684 (Group 2) treatment arm.||0.969|-4.81|
72367799|NCT01263197|144245395|SUPERIORITY_OR_OTHER||LS mean difference|2.47|||||TWO_SIDED|95.0|-1.15|6.1||||||Difference of LS means (test minus reference) for the maximum changes in diastolic blood pressure on Day 1, where test is the LY2216684+propranolol treatment arm and reference is the propranolol treatment arm.||6.10|-1.15|
72367800|NCT01263197|144245395|SUPERIORITY_OR_OTHER||LS mean difference|9.12|||||TWO_SIDED|95.0|4.3|13.9||||||Difference of LS means (test minus reference) for the minimum changes in diastolic blood pressure on Day 1, where test is the LY2216684+propranolol treatment arm and reference is the propranolol treatment arm.||13.9|4.30|
72367801|NCT01263197|144245395|SUPERIORITY_OR_OTHER||LS mean difference|6.03|||||TWO_SIDED|95.0|3.12|8.94||||||Difference of LS means (test minus reference) for the average changes in diastolic blood pressure on Day 1, where test is the LY2216684+propranolol treatment arm and reference is the propranolol treatment arm.||8.94|3.12|
72367802|NCT01263197|144245395|SUPERIORITY_OR_OTHER||LS mean difference|-0.913|||||TWO_SIDED|95.0|-4.65|2.82||||||Difference of LS means (test minus reference) for the maximum changes in diastolic blood pressure on Day 3, where test is the LY2216684+albuterol treatment arm and reference is the LY2216684 (Group 1) treatment arm.||2.82|-4.65|
72367803|NCT01263197|144245395|SUPERIORITY_OR_OTHER||LS mean difference|-0.444|||||TWO_SIDED|95.0|-4.33|3.44||||||Difference of LS means (test minus reference) for the minimum changes in diastolic blood pressure on Day 3, where test is the LY2216684+albuterol treatment arm and reference is the LY2216684 (Group 1) treatment arm.||3.44|-4.33|
72367804|NCT01263197|144245395|SUPERIORITY_OR_OTHER||LS mean difference|0.378|||||TWO_SIDED|95.0|-2.2|2.95||||||Difference of LS means (test minus reference) for the average changes in diastolic blood pressure on Day 3, where test is the LY2216684+albuterol treatment arm and reference is the LY2216684 (Group 1) treatment arm.||2.95|-2.20|
72367805|NCT01263197|144245395|SUPERIORITY_OR_OTHER||LS mean difference|0.878|||||TWO_SIDED|95.0|-2.86|4.62||||||Difference of LS means (test minus reference) for the maximum changes in diastolic blood pressure on Day 3, where test is the LY2216684+albuterol treatment arm and reference is the albuterol treatment arm.||4.62|-2.86|
72367806|NCT01263197|144245395|SUPERIORITY_OR_OTHER||LS mean difference|2.92|||||TWO_SIDED|95.0|-0.966|6.8||||||Difference of LS means (test minus reference) for the minimum changes in diastolic blood pressure on Day 3, where test is the LY2216684+albuterol treatment arm and reference is the albuterol treatment arm.||6.80|-0.966|
72367807|NCT01263197|144245395|SUPERIORITY_OR_OTHER||LS mean difference|2.94|||||TWO_SIDED|95.0|0.366|5.52||||||Difference of LS means (test minus reference) for the average changes in diastolic blood pressure on Day 3, where test is the LY2216684+albuterol treatment arm and reference is the albuterol treatment arm.||5.52|0.366|
72367808|NCT01263197|144245395|SUPERIORITY_OR_OTHER||LS mean difference|-2.88|||||TWO_SIDED|95.0|-6.84|1.07||||||Difference of LS means (test minus reference) for the maximum changes in diastolic blood pressure on Day 3, where test is the LY2216684+propranolol treatment arm and reference is the LY2216684 (Group 2) treatment arm.||1.07|-6.84|
72367809|NCT01263197|144245395|SUPERIORITY_OR_OTHER||LS mean difference|-0.975|||||TWO_SIDED|95.0|-5.39|3.44||||||Difference of LS means (test minus reference) for the minimum changes in diastolic blood pressure on Day 3, where test is the LY2216684+propranolol treatment arm and reference is the LY2216684 (Group 2) treatment arm.||3.44|-5.39|
72367810|NCT01263197|144245395|SUPERIORITY_OR_OTHER||LS mean difference|-1.82|||||TWO_SIDED|95.0|-5.3|1.66||||||Difference of LS means (test minus reference) for the average changes in diastolic blood pressure on Day 3, where test is the LY2216684+propranolol treatment arm and reference is the LY2216684 (Group 2) treatment arm.||1.66|-5.30|
72367811|NCT01263197|144245395|SUPERIORITY_OR_OTHER||LS mean difference|5.6|||||TWO_SIDED|95.0|1.63|9.56||||||Difference of LS means (test minus reference) for the maximum changes in diastolic blood pressure on Day 3, where test is the LY2216684+propranolol treatment arm and reference is the propranolol treatment arm.||9.56|1.63|
72367812|NCT01263197|144245395|SUPERIORITY_OR_OTHER||LS mean difference|7.82|||||TWO_SIDED|95.0|3.39|12.3||||||Difference of LS means (test minus reference) for the minimum changes in diastolic blood pressure on Day 3, where test is the LY2216684+propranolol treatment arm and reference is the propranolol treatment arm.||12.3|3.39|
72367813|NCT01263197|144245395|SUPERIORITY_OR_OTHER||LS mean difference|6.6|||||TWO_SIDED|95.0|3.11|10.1||||||Difference of LS means (test minus reference) for the average changes in diastolic blood pressure on Day 3, where test is the LY2216684+propranolol treatment arm and reference is the propranolol treatment arm.||10.1|3.11|
72367814|NCT01263197|144245395|SUPERIORITY_OR_OTHER||LS mean difference|0.847|||||TWO_SIDED|95.0|-3.23|4.92||||||Difference of LS means (test minus reference) for the maximum changes in diastolic blood pressure on Day 5, where test is the LY2216684+albuterol treatment arm and reference is the LY2216684 (Group 1) treatment arm.||4.92|-3.23|
72367815|NCT01263197|144245395|SUPERIORITY_OR_OTHER||LS mean difference|-3.48|||||TWO_SIDED|95.0|-8.17|1.21||||||Difference of LS means (test minus reference) for the minimum changes in diastolic blood pressure on Day 5, where test is the LY2216684+albuterol treatment arm and reference is the LY2216684 (Group 1) treatment arm.||1.21|-8.17|
72367816|NCT01263197|144245395|SUPERIORITY_OR_OTHER||LS mean difference|-0.372|||||TWO_SIDED|95.0|-2.88|2.14||||||Difference of LS means (test minus reference) for the average changes in diastolic blood pressure on Day 5, where test is the LY2216684+albuterol treatment arm and reference is the LY2216684 (Group 1) treatment arm.||2.14|-2.88|
72367817|NCT01263197|144245395|SUPERIORITY_OR_OTHER||LS mean difference|1.9|||||TWO_SIDED|95.0|-2.17|5.98||||||Difference of LS means (test minus reference) for the maximum changes in diastolic blood pressure on Day 5, where test is the LY2216684+albuterol treatment arm and reference is the albuterol treatment arm.||5.98|-2.17|
72367818|NCT01263197|144245395|SUPERIORITY_OR_OTHER||LS mean difference|1.07|||||TWO_SIDED|95.0|-3.62|5.76||||||Difference of LS means (test minus reference) for the minimum changes in diastolic blood pressure on Day 5, where test is the LY2216684+albuterol treatment arm and reference is the albuterol treatment arm.||5.76|-3.62|
72367819|NCT01263197|144245395|SUPERIORITY_OR_OTHER||LS mean difference|3.03|||||TWO_SIDED|95.0|0.522|5.55||||||Difference of LS means (test minus reference) for the average changes in diastolic blood pressure on Day 5, where test is the LY2216684+albuterol treatment arm and reference is the albuterol treatment arm.||5.55|0.522|
72367820|NCT01263197|144245395|SUPERIORITY_OR_OTHER||LS mean difference|0.737|||||TWO_SIDED|95.0|-3.9|5.38||||||Difference of LS means (test minus reference) for the maximum changes in diastolic blood pressure on Day 5, where test is the LY2216684+propranolol treatment arm and reference is the LY2216684 (Group 2) treatment arm.||5.38|-3.90|
72367821|NCT01263197|144245395|SUPERIORITY_OR_OTHER||LS mean difference|-1.95|||||TWO_SIDED|95.0|-6.36|2.47||||||Difference of LS means (test minus reference) for the minimum changes in diastolic blood pressure on Day 5, where test is the LY2216684+propranolol treatment arm and reference is the LY2216684 (Group 2) treatment arm.||2.47|-6.36|
72367822|NCT01263197|144245395|SUPERIORITY_OR_OTHER||LS mean difference|-1.17|||||TWO_SIDED|95.0|-4.79|2.45||||||Difference of LS means (test minus reference) for the average changes in diastolic blood pressure on Day 5, where test is the LY2216684+propranolol treatment arm and reference is the LY2216684 (Group 2) treatment arm.||2.45|-4.79|
72367823|NCT01263197|144245395|SUPERIORITY_OR_OTHER||LS mean difference|7.25|||||TWO_SIDED|95.0|2.59|11.9||||||Difference of LS means (test minus reference) for the maximum changes in diastolic blood pressure on Day 5, where test is the LY2216684+propranolol treatment arm and reference is the propranolol treatment arm.||11.9|2.59|
72367824|NCT01263197|144245395|SUPERIORITY_OR_OTHER||LS mean difference|5.58|||||TWO_SIDED|95.0|1.13|10.0||||||Difference of LS means (test minus reference) for the minimum changes in diastolic blood pressure on Day 5, where test is the LY2216684+propranolol treatment arm and reference is the propranolol treatment arm.||10.0|1.13|
72367825|NCT01263197|144245395|SUPERIORITY_OR_OTHER||LS mean difference|5.53|||||TWO_SIDED|95.0|1.89|9.16||||||Difference of LS means (test minus reference) for the average changes in diastolic blood pressure on Day 5, where test is the LY2216684+propranolol treatment arm and reference is the propranolol treatment arm.||9.16|1.89|
72367826|NCT01189032|144245402|SUPERIORITY_OR_OTHER|||||||0.004||||||It's the p-value of linear trend. It's adjusted for multiplicity.|maximum contrast method|To confirm dose-response relation, two contrasts were provided; linear trend (-1, 0, 1), and saturated at 1% DE-089 ophthalmic solution (-2, 1, 1).||||||0.004
72367827|NCT01189032|144245402|SUPERIORITY_OR_OTHER|||||||0.006||||||It's the p-value of Saturated at 1% DE-089. It's adjusted for multiplicity.|maximum contrast method|To confirm dose-response relation, two contrasts were provided; linear trend (-1, 0, 1), and saturated at 1% DE-089 ophthalmic solution (-2, 1, 1).||||||0.006
72367828|NCT00473382|144245403|SUPERIORITY_OR_OTHER||Difference in percentage at Month 24|20.8|||<|0.0001|TWO_SIDED|95.0|11.4|30.2||An adjustment was made for multiple treatment comparisons of the ranibizumab dose groups with the control group.|Cochran-Mantel-Haenszel|The analysis was stratified by baseline BCVA score (≤55, \>55 letters), baseline HbA1c (≤8%, \>8%), and prior therapy for ME in the study eye (yes, no).|The percentage for each group and the difference in percentage between groups were estimated using the weighted average of the observed percentages and the differences in observed percentages over the strata using the Cochran-Mantel-Haenszel weights.|||30.2|11.4|<0.0001
72367829|NCT00473382|144245403|SUPERIORITY_OR_OTHER||Difference in percentage at Month 24|33.3|||<|0.0001|TWO_SIDED|95.0|23.8|42.8||An adjustment was made for multiple treatment comparisons of the ranibizumab dose groups with the control group.|Cochran-Mantel-Haenszel|The analysis was stratified by baseline BCVA score (≤55, \>55 letters), baseline HbA1c (≤8%, \>8%), and prior therapy for ME in the study eye (yes, no).|The percentage for each group and the difference in percentage between groups were estimated using the weighted average of the observed percentages and the differences in observed percentages over the strata using the Cochran-Mantel-Haenszel weights.|||42.8|23.8|<0.0001
72367830|NCT00473382|144245404|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.5|||<|0.0001|TWO_SIDED|95.0|5.4|11.5||To manage the type I error rate while testing multiple secondary efficacy endpoints for statistical significance, a type I error management plan was implemented. Secondary endpoints were prioritized and tested using a hierarchical testing procedure.|ANOVA|The analysis was stratified by baseline BCVA score (≤55, \>55 letters), baseline HbA1c (≤8%, \>8%), and prior therapy for ME in the study eye (yes, no).||The analysis summarized in this section is for the Month 24 time point, comparing the outcome for patients randomized to ranibizumab versus sham injections during the controlled treatment period. The statistical analysis for the Outcome Measure at Month 36 is not shown here. The statistical analysis was not performed at Month 48.||11.5|5.4|<0.0001
72367831|NCT00473382|144245404|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.9|||<|0.0001|TWO_SIDED|95.0|6.4|13.3||To manage the type I error rate while testing multiple secondary efficacy endpoints for statistical significance, a type I error management plan was implemented. Secondary endpoints were prioritized and tested using a hierarchical testing procedure.|ANOVA|The analysis was stratified by baseline BCVA score (≤55, \>55 letters), baseline HbA1c (≤8%, \>8%), and prior therapy for ME in the study eye (yes, no).||The analysis summarized in this section is for the Month 24 time point, comparing the outcome for patients randomized to ranibizumab versus sham injections during the controlled treatment period. The statistical analysis for the Outcome Measure at Month 36 is not shown here. The statistical analysis was not performed at Month 48.||13.3|6.4|<0.0001
72367832|NCT00473382|144245405|SUPERIORITY_OR_OTHER||Difference in percentage at Month 24|21.4||||0.0002|TWO_SIDED|95.0|10.8|31.9||To manage the type I error rate while testing multiple secondary efficacy endpoints for statistical significance, a type I error management plan was implemented. Secondary endpoints were prioritized and tested using a hierarchical testing procedure.|Cochran-Mantel-Haenszel|The analysis was stratified by baseline BCVA score (≤55, \>55 letters), baseline HbA1c (≤8%, \>8%), and prior therapy for ME in the study eye (yes, no).|The percentage for each group and the difference in percentage between groups were estimated using the weighted average of the observed percentages and the differences in observed percentages over the strata using the Cochran-Mantel-Haenszel weights.|The analysis summarized in this section is for the Month 24 time point, comparing the outcome for patients randomized to ranibizumab versus sham injections during the controlled treatment period. The statistical analysis for the Outcome Measure at Month 36 is not shown here. The statistical analysis was not performed at Month 48.||31.9|10.8|0.0002
72367833|NCT00473382|144245405|SUPERIORITY_OR_OTHER||Difference in percentage at Month 24|27.1|||<|0.0001|TWO_SIDED|95.0|16.4|37.9||To manage the type I error rate while testing multiple secondary efficacy endpoints for statistical significance, a type I error management plan was implemented. Secondary endpoints were prioritized and tested using a hierarchical testing procedure.|Cochran-Mantel-Haenszel|The analysis was stratified by baseline BCVA score (≤55, \>55 letters), baseline HbA1c (≤8%, \>8%), and prior therapy for ME in the study eye (yes, no).|The percentage for each group and the difference in percentage between groups were estimated using the weighted average of the observed percentages and the differences in observed percentages over the strata using the Cochran-Mantel-Haenszel weights.|The analysis summarized in this section is for the Month 24 time point, comparing the outcome for patients randomized to ranibizumab versus sham injections during the controlled treatment period. The statistical analysis for the Outcome Measure at Month 36 is not shown here. The statistical analysis was not performed at Month 48.||37.9|16.4|<0.0001
72367834|NCT00473382|144245406|SUPERIORITY_OR_OTHER||Difference in percentage at Month 24|7.1||||0.0119|TWO_SIDED|95.0|1.7|12.6||To manage the type I error rate while testing multiple secondary efficacy endpoints for statistical significance, a type I error management plan was implemented. Secondary endpoints were prioritized and tested using a hierarchical testing procedure.|Cochran-Mantel-Haenszel|The analysis was stratified by baseline BCVA score (≤55, \>55 letters), baseline HbA1c (≤8%, \>8%), and prior therapy for ME in the study eye (yes, no).|The percentage for each group and the difference in percentage between groups were estimated using the weighted average of the observed percentages and the differences in observed percentages over the strata using the Cochran-Mantel-Haenszel weights.|The analysis summarized in this section is for the Month 24 time point, comparing the outcome for patients randomized to ranibizumab versus sham injections during the controlled treatment period. The statistical analysis for the Outcome Measure at Month 36 is not shown here. The statistical analysis was not performed at Month 48.||12.6|1.7|0.0119
72367835|NCT00473382|144245406|SUPERIORITY_OR_OTHER||Difference in percentage at Month 24|4.5||||0.1384|TWO_SIDED|95.0|-1.2|10.1||To manage the type I error rate while testing multiple secondary efficacy endpoints for statistical significance, a type I error management plan was implemented. Secondary endpoints were prioritized and tested using a hierarchical testing procedure.|Cochran-Mantel-Haenszel|The analysis was stratified by baseline BCVA score (≤55, \>55 letters), baseline HbA1c (≤8%, \>8%), and prior therapy for ME in the study eye (yes, no).|The percentage for each group and the difference in percentage between groups were estimated using the weighted average of the observed percentages and the differences in observed percentages over the strata using the Cochran-Mantel-Haenszel weights.|The analysis summarized in this section is for the Month 24 time point, comparing the outcome for patients randomized to ranibizumab versus sham injections during the controlled treatment period. The statistical analysis for the Outcome Measure at Month 36 is not shown here. The statistical analysis was not performed at Month 48.||10.1|-1.2|0.1384
72367836|NCT00473382|144245407|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.3||||0.0102|TWO_SIDED|95.0|2.0|14.6||To manage the type I error rate while testing multiple secondary efficacy endpoints for statistical significance, a type I error management plan was implemented. Secondary endpoints were prioritized and tested using a hierarchical testing procedure.|ANOVA|The analysis was stratified by baseline BCVA score (≤55, \>55 letters), baseline HbA1c (≤8%, \>8%), and prior therapy for ME in the study eye (yes, no).||The analysis summarized in this section is for the Month 24 time point, comparing the outcome for patients randomized to ranibizumab versus sham injections during the controlled treatment period. The statistical analysis for the Outcome Measure at Month 36 is not shown here.||14.6|2.0|0.0102
72368816|NCT02637037|144247321|NON_INFERIORITY_OR_EQUIVALENCE|If the 90% CIs for both dapagliflozin and metformin geometric mean ratio of AUC is entirely contained within an 80.00% to 125.00% interval, it will be concluded the 2 manufacturing sites are bioequivalent.|Ratios of Geometric means|0.95|||||TWO_SIDED|90.0|0.87|1.03||||||Dapagliflozin: Statistical Assessment of Bioequivalence for Dapagliflozin following administration Dapagliflozin/Metformin XR 10/1000 mg for Treatment G and H.||1.03|0.87|
72367837|NCT00473382|144245407|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.2||||0.0005|TWO_SIDED|95.0|5.1|17.3||To manage the type I error rate while testing multiple secondary efficacy endpoints for statistical significance, a type I error management plan was implemented. Secondary endpoints were prioritized and tested using a hierarchical testing procedure.|ANOVA|The analysis was stratified by baseline BCVA score (≤55, \>55 letters), baseline HbA1c (≤8%, \>8%), and prior therapy for ME in the study eye (yes, no).||The analysis summarized in this section is for the Month 24 time point, comparing the outcome for patients randomized to ranibizumab versus sham injections during the controlled treatment period. The statistical analysis for the Outcome Measure at Month 36 is not shown here.||17.3|5.1|0.0005
72367838|NCT00473382|144245408|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-111.8|||<|0.0001|TWO_SIDED|95.0|-151.6|-72.0||To manage the type I error rate while testing multiple secondary efficacy endpoints for statistical significance, a type I error management plan was implemented. Secondary endpoints were prioritized and tested using a hierarchical testing procedure.|ANCOVA|The analysis was stratified by baseline BCVA score (≤55, \>55 letters), baseline HbA1c (≤8%, \>8%), and prior therapy for ME in the study eye (yes, no).||The analysis summarized in this section is for the Month 24 time point, comparing the outcome for patients randomized to ranibizumab versus sham injections during the controlled treatment period. The statistical analysis for the Outcome Measure at Month 36 is not shown here. The statistical analysis was not performed at Month 48.||-72.0|-151.6|<0.0001
72367839|NCT00473382|144245408|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-132.2|||<|0.0001|TWO_SIDED|95.0|-169.7|-94.8||To manage the type I error rate while testing multiple secondary efficacy endpoints for statistical significance, a type I error management plan was implemented. Secondary endpoints were prioritized and tested using a hierarchical testing procedure.|ANCOVA|The analysis was stratified by baseline BCVA score (≤55, \>55 letters), baseline HbA1c (≤8%, \>8%), and prior therapy for ME in the study eye (yes, no).||The analysis summarized in this section is for the Month 24 time point, comparing the outcome for patients randomized to ranibizumab versus sham injections during the controlled treatment period. The statistical analysis for the Outcome Measure at Month 36 is not shown here. The statistical analysis was not performed at Month 48.||-94.8|-169.7|<0.0001
72367840|NCT00473382|144245409|SUPERIORITY_OR_OTHER||Difference in percentage at Month 24|-4.3||||0.0853|TWO_SIDED|95.0|-9.3|0.8||To manage the type I error rate while testing multiple secondary efficacy endpoints for statistical significance, a type I error management plan was implemented. Secondary endpoints were prioritized and tested using a hierarchical testing procedure.|Cochran-Mantel-Haenszel|The analysis was stratified by baseline BCVA score (≤55, \>55 letters), baseline HbA1c (≤8%, \>8%), and prior therapy for ME in the study eye (yes, no).|The percentage for each group and the difference in percentage between groups were estimated using the weighted average of the observed percentages and the differences in observed percentages over the strata using the Cochran-Mantel-Haenszel weights.|The analysis summarized in this section is for the Month 24 time point, comparing the outcome for patients randomized to ranibizumab versus sham injections during the controlled treatment period. The statistical analysis for the Outcome Measure at Month 36 is not shown here.||0.8|-9.3|0.0853
72367841|NCT00473382|144245409|SUPERIORITY_OR_OTHER||Difference in percentage at Month 24|-5.8||||0.0073|TWO_SIDED|95.0|-9.8|-1.7||To manage the type I error rate while testing multiple secondary efficacy endpoints for statistical significance, a type I error management plan was implemented. Secondary endpoints were prioritized and tested using a hierarchical testing procedure.|Cochran-Mantel-Haenszel|The analysis was stratified by baseline BCVA score (≤55, \>55 letters), baseline HbA1c (≤8%, \>8%), and prior therapy for ME in the study eye (yes, no).|The percentage for each group and the difference in percentage between groups were estimated using the weighted average of the observed percentages and the differences in observed percentages over the strata using the Cochran-Mantel-Haenszel weights.|The analysis summarized in this section is for the Month 24 time point, comparing the outcome for patients randomized to ranibizumab versus sham injections during the controlled treatment period. The statistical analysis for the Outcome Measure at Month 36 is not shown here.||-1.7|-9.8|0.0073
72367842|NCT00473382|144245410|SUPERIORITY_OR_OTHER||Difference in percentage at Month 24|14.0||||0.0002|TWO_SIDED|95.0|6.8|21.1||To manage the type I error rate while testing multiple secondary efficacy endpoints for statistical significance, a type I error management plan was implemented. Secondary endpoints were prioritized and tested using a hierarchical testing procedure.|Cochran-Mantel-Haenszel|The analysis was stratified by baseline BCVA score (≤55, \>55 letters), baseline HbA1c (≤8%, \>8%), and prior therapy for ME in the study eye (yes, no).|The percentage for each group and the difference in percentage between groups were estimated using the weighted average of the observed percentages and the differences in observed percentages over the strata using the Cochran-Mantel-Haenszel weights.|||21.1|6.8|0.0002
72367843|NCT00473382|144245410|SUPERIORITY_OR_OTHER||Difference in percentage at Month 24|28.3|||<|0.0001|TWO_SIDED|95.0|20.2|36.4||To manage the type I error rate while testing multiple secondary efficacy endpoints for statistical significance, a type I error management plan was implemented. Secondary endpoints were prioritized and tested using a hierarchical testing procedure.|Cochran-Mantel-Haenszel|The analysis was stratified by baseline BCVA score (≤55, \>55 letters), baseline HbA1c (≤8%, \>8%), and prior therapy for ME in the study eye (yes, no).|The percentage for each group and the difference in percentage between groups were estimated using the weighted average of the observed percentages and the differences in observed percentages over the strata using the Cochran-Mantel-Haenszel weights.|||36.4|20.2|<0.0001
72367844|NCT00473382|144245411|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9|||<|0.0001|TWO_SIDED|95.0|-1.3|-0.5||To manage the type I error rate while testing multiple secondary efficacy endpoints for statistical significance, a type I error management plan was implemented. Secondary endpoints were prioritized and tested using a hierarchical testing procedure.|ANOVA|The analysis was stratified by baseline BCVA score (≤55, \>55 letters), baseline HbA1c (≤8%, \>8%), and prior therapy for ME in the study eye (yes, no).||The analysis summarized in this section is for the Month 24 time point, comparing the outcome for patients randomized to ranibizumab versus sham injections during the controlled treatment period. The statistical analysis for the Outcome Measure at Month 36 is not shown here.||-0.5|-1.3|<0.0001
72367845|NCT00473382|144245411|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.3|||<|0.0001|TWO_SIDED|95.0|-1.6|-1.0||To manage the type I error rate while testing multiple secondary efficacy endpoints for statistical significance, a type I error management plan was implemented. Secondary endpoints were prioritized and tested using a hierarchical testing procedure.|ANOVA|The analysis was stratified by baseline BCVA score (≤55, \>55 letters), baseline HbA1c (≤8%, \>8%), and prior therapy for ME in the study eye (yes, no).||The analysis summarized in this section is for the Month 24 time point, comparing the outcome for patients randomized to ranibizumab versus sham injections during the controlled treatment period. The statistical analysis for the Outcome Measure at Month 36 is not shown here.||-1.0|-1.6|<0.0001
72367846|NCT01134055|144245417|SUPERIORITY_OR_OTHER|||||||0.1974||||||Adjusted p-Value has been presented.|ANOVA|||Statistics for Injection Rate at 28 Weeks is presented||||0.1974
72367847|NCT01134055|144245417|SUPERIORITY_OR_OTHER|||||||0.8263||||||Adjusted p-Value has been presented.|ANOVA|||Statistics for Injection Rate at 28 Weeks is presented||||0.8263
72367848|NCT01134055|144245417|SUPERIORITY_OR_OTHER|||||||0.8263||||||Adjusted p-Value has been presented.|ANOVA|||Statistics for Injection Rate at 28 Weeks is presented||||0.8263
72367849|NCT01134055|144245417|SUPERIORITY_OR_OTHER|||||||0.8263||||||Adjusted p-Value has been presented.|ANOVA|||Statistics for Injection Rate at 28 Weeks is presented||||0.8263
72367850|NCT01134055|144245417|SUPERIORITY_OR_OTHER|||||||0.7418||||||Adjusted p-Value has been presented.|ANOVA|||Statistics for Injection Rate at 28 Weeks is presented||||0.7418
72367851|NCT01134055|144245417|SUPERIORITY_OR_OTHER|||||||0.2429||||||Adjusted p-Value has been presented.|ANOVA|||Statistics for Overall Injection Rate at 52 weeks is presented||||0.2429
72367852|NCT01134055|144245417|SUPERIORITY_OR_OTHER|||||||0.97||||||Adjusted p-Value has been presented.|ANOVA|||Statistics for Overall Injection Rate at 52 weeks is presented||||0.9700
72367853|NCT01134055|144245417|SUPERIORITY_OR_OTHER|||||||0.97||||||Adjusted p-Value has been presented.|ANOVA|||Statistics for Overall Injection Rate at 52 weeks is presented||||0.9700
72367854|NCT01134055|144245417|SUPERIORITY_OR_OTHER|||||||0.97||||||Adjusted p-Value has been presented.|ANOVA|||Statistics for Overall Injection Rate at 52 weeks is presented||||0.9700
72367855|NCT01134055|144245417|SUPERIORITY_OR_OTHER|||||||0.7673||||||Adjusted p-Value has been presented.|ANOVA|||Statistics for Overall Injection Rate at 52 weeks is presented||||0.7673
72367856|NCT00847210|144245446|SUPERIORITY_OR_OTHER|||||||0.095||95.0||||There was no statistical significant difference (p-value \>0.05) in Tmax between the 30 mg and 60 mg dose group. Both age group and site did not have statistically significant effects on Tmax.|ANOVA|||This study was not powered for any hypothesis testing. For Tmax, an analysis of variance (ANOVA) model was fitted that included fixed effect of age group, regimen and interaction of age group and regimen. If the interaction term was not statistically significant, it was not included in the final model. The site effect was also tested in the model, and was not included in the final model if it was not statistically significant (P\>0.05). Pairwise comparisons between regimens were conducted.||||0.095
72367857|NCT00847210|144245447|SUPERIORITY_OR_OTHER||ratio of the central values for Cmax|1.21||||0.289|TWO_SIDED|90.0|0.897|1.63|||ANOVA||Ninety percent confidence intervals for assessing the dose proportionality of dexlansoprazole pharmacokinetics between regimens were computed based on the frame work of ANOVA.|This study was not powered for any hypothesis testing. For natural logarithm of dose-normalized Cmax, an ANOVA model was fitted that included fixed effect of age group, regimen and interaction of age group and regimen. If the interaction term was not statistically significant, it was not included in the final model. Site effect was tested in the model, and was not included in the final model if not statistically significant (P\>0.05). Pairwise comparisons between regimens were conducted.||1.630|0.897|0.289
72367858|NCT00847210|144245448|SUPERIORITY_OR_OTHER||Ratio of the dose-normalized AUC(0-tlqc)|1.158||||0.402|TWO_SIDED|90.0|0.864|1.551|||ANOVA||Ninety percent confidence intervals for assessing the dose proportionality of dexlansoprazole AUC(0-tlqc) between regimens were computed based on the frame work of ANOVA.|This study was not powered for any hypothesis testing. For Tmax, an ANOVA model was fitted that included fixed effect of age group (12-14 years and 15 17 years), regimen and interaction of age group and regimen. If the interaction term was not statistically significant, it was not included in the final model. The site effect was also tested in the model, and was not included in the final model if it was not statistically significant (P\>0.05). Pairwise comparisons between regimens were conducted.||1.551|0.864|0.402
72367859|NCT00847210|144245449|SUPERIORITY_OR_OTHER||Ratio of the central values for dose-nor|1.168||||0.388|TWO_SIDED|90.0|0.864|1.579|||ANOVA||Ninety percent confidence intervals for assessing the dose proportionality of dexlansoprazole AUC(0-24) between regimens were computed based on the frame work of ANOVA.|This study was not powered for any hypothesis testing. For Tmax, an ANOVA model was fitted that included fixed effect of age group (12-14 years and 15 17 years), regimen and interaction of age group and regimen. If the interaction term was not statistically significant, it was not included in the final model. The site effect was also tested in the model, and was not included in the final model if it was not statistically significant (P\>0.05). Pairwise comparisons between regimens were conducted.||1.579|0.864|0.388
72367860|NCT00357903|144245521|SUPERIORITY_OR_OTHER||Standardized incidence rate|0.0||||||95.0|0.0|53.87||||||||53.87|0.00|
72367861|NCT00357903|144245521|SUPERIORITY_OR_OTHER||Standardized incidence rate|1.3||||||95.0|0.97|1.71||||||||1.71|0.97|
72367862|NCT00606593|144245523|SUPERIORITY_OR_OTHER||Least square means treatment effect|-10.4||||0.0018|TWO_SIDED|95.0|-17.0|-3.9|||Linear model|||||-3.9|-17.0|0.0018
72367863|NCT00606593|144245523|SUPERIORITY_OR_OTHER||Least square means treatment effect|-19.2|||<|0.0001|TWO_SIDED|95.0|-25.7|-12.6|||Linear model|||||-12.6|-25.7|<0.0001
72367864|NCT00606593|144245523|SUPERIORITY_OR_OTHER||Least square means treatment effect|-31.4|||<|0.0001|TWO_SIDED|95.0|-38.0|-24.9|||Linear model|||||-24.9|-38.0|<0.0001
72367865|NCT00606593|144245523|SUPERIORITY_OR_OTHER||Least square means treatment effect|-46.5|||<|0.0001|TWO_SIDED|95.0|-53.3|-39.9|||Linear model|||||-39.9|-53.3|<0.0001
72367866|NCT00606593|144245524|SUPERIORITY_OR_OTHER||Least square means treatment effect|14.3|||<|0.0001|TWO_SIDED|95.0|7.4|21.2|||Linear model|||||21.2|7.4|<0.0001
72367867|NCT00606593|144245524|SUPERIORITY_OR_OTHER||Least square means treatment effect|21.5|||<|0.0001|TWO_SIDED|95.0|14.6|28.4|||Linear model|||||28.4|14.6|<0.0001
72367868|NCT00606593|144245524|SUPERIORITY_OR_OTHER||Least square means treatment effect|34.7|||<|0.0001|TWO_SIDED|95.0|27.8|41.6|||Linear model|||||41.6|27.8|<0.0001
72367869|NCT00606593|144245524|SUPERIORITY_OR_OTHER||Least square means treatment effect|55.1|||<|0.0001|TWO_SIDED|95.0|48.2|62.0|||Linear model|||||62.0|48.2|<0.0001
72367870|NCT06042855|144245532|SUPERIORITY|Posterior probability of efficacy (P(HR\>1))|Hazard Ratio (HR)|0.96|||||TWO_SIDED|95.0|0.89|1.03|||||The interval is a highest-density credible interval. Adjustment variables: randomization, age, sex, duration of symptoms prior to study drug, calendar time, vaccination status, geographic region, call center indicator, and baseline symptom severity.|||1.03|0.89|
72367871|NCT06042855|144245533|SUPERIORITY||Hazard Ratio (HR)|1.43|||||TWO_SIDED|95.0|0.32|6.38||||||No hypothesis test or decision rule was evaluated.||6.38|0.32|
72367872|NCT06042855|144245536|SUPERIORITY||Hazard Ratio (HR)|1.25|||||TWO_SIDED|95.0|0.82|1.78|||||The interval is a highest-density credible interval. Adjustment variables: randomization, age, sex, duration of symptoms prior to study drug, calendar time, vaccination status, geographic region, call center indicator, and baseline symptom severity.|No hypothesis test or decision rule was evaluated.||1.78|0.82|
72367873|NCT06042855|144245537|SUPERIORITY||Odds Ratio (OR)|0.99|||||TWO_SIDED|95.0|0.66|1.31|||||The interval is a highest-density credible interval. Adjustment variables: randomization, age, sex, duration of symptoms prior to study drug, calendar time, vaccination status, geographic region, call center indicator, and baseline symptom severity.|No hypothesis test or decision rule was evaluated.||1.31|0.66|
72367874|NCT06042855|144245538|SUPERIORITY||Odds Ratio (OR)|0.96|||||TWO_SIDED|95.0|0.57|1.41|||||The interval is a highest-density credible interval. Adjustment variables: randomization, age, sex, duration of symptoms prior to study drug, calendar time, vaccination status, geographic region, call center indicator, and baseline symptom severity.|No hypothesis test or decision rule was evaluated.||1.41|0.57|
72367875|NCT06042855|144245539|SUPERIORITY||Odds Ratio (OR)|1.08|||||TWO_SIDED|95.0|0.78|1.42|||||The interval is a highest-density credible interval. Adjustment variables: randomization, age, sex, duration of symptoms prior to study drug, calendar time, vaccination status, geographic region, call center indicator, and baseline symptom severity.|No hypothesis test or decision rule was evaluated.||1.42|0.78|
72367876|NCT06042855|144245547|SUPERIORITY|Posterior probability of efficacy (P(Difference in MTU (Active - Placebo)\<0))|Difference in model estimate time unwell|0.03|||||TWO_SIDED|95.0|-0.21|0.28|||||The mean time unwell is estimated from receipt of study drug to study day 14. The interval is a highest density credible interval.|No hypothesis test or decision rule was evaluated.||0.28|-0.21|
72367877|NCT06042855|144245548|SUPERIORITY|Posterior probability of efficacy (P(Difference days benefit (Active - Placebo)\>0))|Difference in model estimate time unwell|-0.04|||||TWO_SIDED|95.0|-0.34|0.26|||||The interval is a highest density credible interval.|Analysis is exploratory. No hypothesis test or decision rule was evaluated.||0.26|-0.34|
72367878|NCT04546672|144245551|SUPERIORITY||Mean Difference (Final Values)|12.1||||0.58|TWO_SIDED|95.0|-31.1|55.4|||t-test, 2 sided|||||55.4|-31.1|0.58
72367879|NCT04546672|144245552|SUPERIORITY||Mean Difference (Final Values)|12.3|||<|0.001|TWO_SIDED|95.0|9.2|15.4|||t-test, 2 sided|||||15.4|9.2|<0.001
72367880|NCT04546672|144245553|SUPERIORITY||Odds Ratio (OR)|2.3||||0.087|TWO_SIDED|95.0|0.9|6.2|||Fisher Exact|||||6.2|0.9|0.087
72367881|NCT04546672|144245554|SUPERIORITY||Mean Difference (Final Values)|-6.9||||0.48|TWO_SIDED|95.0|-26.4|12.6|||t-test, 2 sided|||||12.6|-26.4|0.48
72367882|NCT04546672|144245555|SUPERIORITY||Mean Difference (Final Values)|16.7||||0.02|TWO_SIDED|95.0|2.3|31.1|||t-test, 2 sided|||||31.1|2.3|0.02
72367883|NCT04546672|144245556|SUPERIORITY||Mean Difference (Final Values)|3.0||||0.27|TWO_SIDED|95.0|-2.2|8.3|||t-test, 2 sided|||||8.3|-2.2|0.27
72367884|NCT00525161|144245562|SUPERIORITY_OR_OTHER||Clinical Response Rate at 3 months|0.0|||||TWO_SIDED||||||||Defined as complete response/partial response after 3 months of adding sorafenib to endocrine therapy|Based on known historical response rate to sorafenib of no better than 5-10%, the study was designed to test the null hypothesis that the clinical response rate is no better than 10% versus the alternative hypothesis that it is at least 25% when sorafenib is added to endocrine therapy. In the first stage, 18 patients were planned for enrollment, and if two or fewer responses were observed, the trial would be terminated. The study stopped after 11 due to slow accrual and withdrawal of funding.||||
72367885|NCT00525161|144245563|SUPERIORITY_OR_OTHER||Median Progression Free Survival|6.1|||||TWO_SIDED|95.0|2.6|11.3||||||||11.3|2.6|
72367886|NCT03848728|144245579|SUPERIORITY||Risk Ratio (RR)|1.1||||0.0019|TWO_SIDED|95.0|1.03|1.16|||TMLE|||||1.16|1.03|0.0019
72367887|NCT02581410|144245597|NON_INFERIORITY|Non-inferiority will be demonstrated if the upper limit of the two-sided 95% confidence interval of the adjusted geometric mean concentration (GMC) ratio (No prev- Zvax over Prev-Zvax) 1 month post-dose 2 is below 1.5 in terms of anti-gE antibodies.|Adjusted GMC ratio|1.04|||||TWO_SIDED|95.0|0.92|1.17|||ANCOVA|||To compare humoral immune responses at 1 month after dose 2 of GSK1437173A (Month 3) in subjects ≥ 65 years of age who received Zostavax ≥ 5 years earlier (Prev-Zvax) as compared to subjects who have never received Zostavax (No prev-Zvax).||1.17|0.92|
72367888|NCT02000115|144245636|NON_INFERIORITY|8.0% non-inferiority margin|Difference in percentages between groups|1.5||||0.006|ONE_SIDED|95.0||5.7||p for non-inferiority|Kaplan-Meier estimates|Kaplan-Meier was used as the method for calculating the endpoint rate|Non-inferiority of the Portico valve to commercially available valves was shown if the upper bound of the 95% confidence interval (1-sided) for the difference in event rates between groups was less than the non-inferiority margin (8·0%)|We analysed the primary effectiveness endpoint in the intention-to- treat (ITT) population using the Kaplan-Meier method to estimate event rates, the Greenwood method to calculate the standard error of the Kaplan-Meier estimates, and assuming an asymptotic normal distribution for event rate estimates.||5.7||0.006
72367889|NCT02000115|144245637|NON_INFERIORITY|8.5% non-inferiority margin|Difference in percentages between groups|4.2||||0.03|ONE_SIDED|95.0||8.1||p for non-inferiority|Kaplan-Meier estimates|Kaplan-Meier was used as the method for calculating the endpoint rate|Non-inferiority of the Portico valve to commercially available valves was shown if the upper bound of the 95% confidence interval (1-sided) for the difference in event rates between groups was less than the non-inferiority margin (8·5%)|We analysed the primary safety endpoint in the intention-to-treat (ITT) population using the Kaplan-Meier method to estimate event rates, the Greenwood method to calculate the standard error of the Kaplan-Meier estimates, and assuming an asymptotic normal distribution for event rate estimates.||8.1||0.03
72367890|NCT02000115|144245639|NON_INFERIORITY|non-inferiority margin of 4%|Difference in percentages between groups|0.4||||0.001|ONE_SIDED|95.0||2.3||p for non-inferiority|Farrington-Manning test|The test statistic is based on the Farrington-Manning method of testing non-inferiority of proportions.|If the upper limit of the 95% confidence interval (1-sided) for the difference of proportions (Portico - CAV) is \< 4%, then non inferiority is demonstrated.|||2.3||0.001
72367891|NCT02000115|144245640|NON_INFERIORITY|non-inferiority margin of 10 points|Mean Difference (Final Values)|-0.5|||<|0.0001|ONE_SIDED|95.0|-3.5|||p for non-inferiority|two-sample t-test|The test statistic is based on two sample t-test|If the lower limit of the 95% confidence interval (1-sided) for the difference of (Portico - CAV) is \> -10, then non inferiority is demonstrated.||||-3.5|<0.0001
72367892|NCT02000115|144245641|NON_INFERIORITY|non-inferiority margin of 6%|Difference in percentages between groups|5.6||||0.4|ONE_SIDED|95.0||8.5||p for non-inferiority|Farrington-Manning test|The test statistic is based on the Farrington-Manning method of testing non-inferiority of proportions|If the upper limit of the 95% confidence interval (1-sided) for the difference of proportions (Portico - CAV) is \< 6%, then non inferiority is demonstrated.|||8.5||0.40
72367893|NCT02000115|144245642|NON_INFERIORITY|non-inferiority margin on -36 meters|Mean Difference (Final Values)|3.5||||0.0003|ONE_SIDED|95.0|-15.4|||p for non-inferiority|two sample t-test|The test statistic is based on a two-sample t-test|If the lower limit of the 95% confidence interval (1-sided) for the difference of (Portico - CAV) is \> -36, then non inferiority is demonstrated.||||-15.4|0.0003
72367894|NCT05006573|144245647|SUPERIORITY||Risk Ratio (RR)|1.14||||0.5911|TWO_SIDED|95.0|0.71|1.82|||negative binomial model|marginal standardization method|The rate ratio (Benralizumab/Placebo) and its 95% CI are estimated using a negative binomial model. The covariates include treatment arm, baseline blood eosinophil category, and number of exacerbations from previous year.|||1.82|0.71|0.5911
72367895|NCT05006573|144245648|SUPERIORITY||Hazard Ratio (HR)|1.12||||0.6677|TWO_SIDED|95.0|0.67|1.91|||Regression, Cox||The analysis is performed using cox proportional hazards model with covariates of treatment group, number of exacerbations in previous year and baseline eosinophil category.|||1.91|0.67|0.6677
72367896|NCT02653417|144245678|SUPERIORITY||Mean Difference (Final Values)|-0.18|||||TWO_SIDED|||||||||Regimen 1 = 5 mg vs Regimen 4 = placebo||||
72367897|NCT02653417|144245678|SUPERIORITY||Mean Difference (Final Values)|0.08|||||TWO_SIDED|||||||||Regimen 2 = 10 mg vs Regimen 4 = placebo||||
72367898|NCT02653417|144245678|SUPERIORITY||Mean Difference (Final Values)|0.46|||||TWO_SIDED|||||||||Regimen 3 = 20 mg vs Regimen 4 = placebo||||
72367899|NCT01106690|144245699|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-0.62|STANDARD_ERROR_OF_MEAN|0.095|<|0.001|TWO_SIDED|95.0|-0.811|-0.437|||ANCOVA|||||-0.437|-0.811|<0.001
72367900|NCT01106690|144245699|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-0.76|STANDARD_ERROR_OF_MEAN|0.096|<|0.001|TWO_SIDED|95.0|-0.951|-0.575|||ANCOVA|||||-0.575|-0.951|<0.001
72367901|NCT01106690|144245700|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.4||||0.007||95.0|1.26|4.57|||Regression, Logistic|||||4.57|1.26|0.007
72367902|NCT01106690|144245700|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.38|||<|0.001|TWO_SIDED|95.0|2.73|10.6|||Regression, Logistic|||||10.60|2.73|<0.001
72367903|NCT01106690|144245701|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-29.4|STANDARD_ERROR_OF_MEAN|3.857|<|0.001|TWO_SIDED|95.0|-36.96|-21.78|||ANCOVA|||||-21.78|-36.96|<0.001
72367904|NCT01106690|144245701|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-35.7|STANDARD_ERROR_OF_MEAN|3.861|<|0.001|TWO_SIDED|95.0|-43.3|-28.11|||ANCOVA|||||-28.11|-43.30|<0.001
72367905|NCT01106690|144245702|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|14.28|STANDARD_ERROR_OF_MEAN|2.521|<|0.001|TWO_SIDED|95.0|9.315|19.236|||ANCOVA|||||19.236|9.315|<0.001
72367906|NCT01106690|144245702|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|17.23|STANDARD_ERROR_OF_MEAN|2.509|<|0.001|TWO_SIDED|95.0|12.293|22.166|||ANCOVA|||||22.166|12.293|<0.001
72367907|NCT01106690|144245703|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-2.7|STANDARD_ERROR_OF_MEAN|0.4|<|0.001|TWO_SIDED|95.0|-3.6|-1.8|||ANCOVA|||||-1.8|-3.6|<0.001
72367908|NCT01106690|144245703|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-3.7|STANDARD_ERROR_OF_MEAN|0.4|<|0.001|TWO_SIDED|95.0|-4.6|-2.8|||ANCOVA|||||-2.8|-4.6|<0.001
72367909|NCT01106690|144245704|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-4.07|STANDARD_ERROR_OF_MEAN|1.43||0.005|TWO_SIDED|95.0|-6.879|-1.251|||ANCOVA|||||-1.251|-6.879|0.005
72367910|NCT01106690|144245704|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-3.46|STANDARD_ERROR_OF_MEAN|1.433||0.016|TWO_SIDED|95.0|-6.281|-0.643|||ANCOVA|||||-0.643|-6.281|0.016
72367911|NCT01106690|144245705|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-12.1|STANDARD_ERROR_OF_MEAN|5.7||0.034|TWO_SIDED|95.0|-12.1|-0.9|||ANCOVA|||||-0.9|-12.1|0.034
72367912|NCT01106690|144245705|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-16.9|STANDARD_ERROR_OF_MEAN|5.7||0.003|TWO_SIDED|95.0|-28.1|-5.8|||ANCOVA|||||-5.8|-28.1|0.003
72367913|NCT01106690|144245706|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|4.8|STANDARD_ERROR_OF_MEAN|1.9||0.01|TWO_SIDED|95.0|1.2|8.5|||ANCOVA|||||8.5|1.2|0.010
72367914|NCT01106690|144245706|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|6.5|STANDARD_ERROR_OF_MEAN|1.9|<|0.001|TWO_SIDED|95.0|2.8|10.2|||ANCOVA|||||10.2|2.8|<0.001
72367915|NCT02919995|144245728|OTHER||Contrast ratio|1.038||||0.0196|TWO_SIDED|95.0|1.007|1.07|||ANCOVA|||||1.07|1.007|0.0196
72367916|NCT02919995|144245728|OTHER||Contrast ratio|1.024||||0.0802|TWO_SIDED|95.0|0.997|1.052|||ANCOVA|||||1.052|0.997|0.0802
72367917|NCT02919995|144245728|OTHER||Contrast ratio|0.986||||0.3487|TWO_SIDED|95.0|0.957|1.017|||ANCOVA|||||1.017|0.957|0.3487
72367918|NCT02919995|144245729|OTHER||Contrast ratio|1.072||||0.0043|TWO_SIDED|95.0|1.026|1.12|||ANCOVA|||||1.12|1.026|0.0043
72367919|NCT02919995|144245729|OTHER||Contrast ratio|1.055||||0.0109|TWO_SIDED|95.0|1.014|1.096|||ANCOVA|||||1.096|1.014|0.0109
72367920|NCT02919995|144245729|OTHER||Contrast ratio|0.984||||0.4306|TWO_SIDED|95.0|0.942|1.027|||ANCOVA|||||1.027|0.942|0.4306
72367921|NCT02919995|144245730|OTHER||Contrast ratio|1.065||||0.0064|TWO_SIDED|95.0|1.021|1.11|||ANCOVA|||||1.11|1.021|0.0064
72367922|NCT02919995|144245730|OTHER||Contrast ratio|1.049||||0.0149|TWO_SIDED|95.0|1.011|1.089|||ANCOVA|||||1.089|1.011|0.0149
72367923|NCT02919995|144245730|OTHER||Contrast ratio|0.945||||0.466|TWO_SIDED|95.0|0.945|1.027|||ANCOVA|||||1.027|0.945|0.466
72367924|NCT02919995|144245731|OTHER||Contrast ratio|1.061||||0.0093|TWO_SIDED|95.0|1.017|1.107|||ANCOVA|||||1.107|1.017|0.0093
72367925|NCT02919995|144245731|OTHER||Contrast ratio|1.042||||0.0333|TWO_SIDED|95.0|1.004|1.082|||ANCOVA|||||1.082|1.004|0.0333
72367926|NCT02919995|144245731|OTHER||Contrast ratio|0.982||||0.3693|TWO_SIDED|95.0|0.941|1.024|||ANCOVA|||||1.024|0.941|0.3693
72367927|NCT01821118|144245796|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.984|STANDARD_ERROR_OF_MEAN|0.112|||TWO_SIDED|90.0|0.82|1.184|||||SE of mean is presented in log e scale.|ROI1: Analysis of the change from baseline in log(slope) was carried out using a Bayesian linear model (ANCOVA). Treatment was a fixed effect within the model and the log(slope) at baseline was included as a covariate.||1.184|0.820|
72367928|NCT01821118|144245796|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.934|STANDARD_ERROR_OF_MEAN|0.075|||TWO_SIDED|90.0|0.825|1.056|||||SE of mean is presented in log e scale.|ROI2: Analysis of the change from baseline in log(slope) was carried out using a Bayesian linear model (ANCOVA). Treatment was a fixed effect within the model and the log(slope) at baseline was included as a covariate.||1.056|0.825|
72367929|NCT01821118|144245797|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.852|STANDARD_ERROR_OF_MEAN|0.091|||TWO_SIDED|90.0|0.735|0.989|||||SE of mean is presented on log e scale.|ROI1: Analysis of the change from baseline in log(slope) was carried out using a Bayesian linear model (ANCOVA). Treatment was a fixed effect within the model and the log(slope) at baseline was included as a covariate.||0.989|0.735|
72367930|NCT01821118|144245797|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.902|STANDARD_ERROR_OF_MEAN|0.082|||TWO_SIDED|90.0|0.788|1.031|||||SE of mean presented on log e scale.|ROI2: Analysis of the change from baseline in log(slope) was carried out using a Bayesian linear model (ANCOVA). Treatment was a fixed effect within the model and the log(slope) at baseline was included as a covariate.||1.031|0.788|
72367931|NCT01821118|144245798|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.005|STANDARD_ERROR_OF_MEAN|0.046|||TWO_SIDED|90.0|0.933|1.086|||||SE of mean presented on log e scale.|ROI1, Day 2: Analysis of the change from baseline in log(time to peak) was carried out using a Bayesian linear model (ANCOVA). Treatment was a fixed effect within the model and the log(time to peak) at baseline was included as a covariate.||1.086|0.933|
72367932|NCT01821118|144245798|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.049|STANDARD_ERROR_OF_MEAN|0.036|||TWO_SIDED|90.0|0.99|1.114|||||SE of mean presented on log e scale.|ROI1, Day 90: Analysis of the change from baseline in log(time to peak) was carried out using a Bayesian linear model (ANCOVA). Treatment was a fixed effect within the model and the log(time to peak) at baseline was included as a covariate.||1.114|0.990|
72367933|NCT01821118|144245798|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.998|STANDARD_ERROR_OF_MEAN|0.032|||TWO_SIDED|90.0|0.947|1.052|||||SE of mean presented on log e scale.|ROI2, Day 2: Analysis of the change from baseline in log(time to peak) was carried out using a Bayesian linear model (ANCOVA). Treatment was a fixed effect within the model and the log(time to peak) at baseline was included as a covariate.||1.052|0.947|
72367934|NCT01821118|144245798|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.01|STANDARD_ERROR_OF_MEAN|0.031|||TWO_SIDED|90.0|0.96|1.063|||||SE of mean presented on log e scale.|ROI2, Day 90: Analysis of the change from baseline in log(time to peak) was carried out using a Bayesian linear model (ANCOVA). Treatment was a fixed effect within the model and the log(time to peak) at baseline was included as a covariate.||1.063|0.960|
72367935|NCT01821118|144245799|SUPERIORITY_OR_OTHER||Estimated Treatment Difference (log e)|0.0602|STANDARD_ERROR_OF_MEAN|0.1281|||TWO_SIDED|90.0|-0.1576|0.2781||||||ROI1, Day 2: Analysis of the change from baseline in log(amplitude) was carried out using a linear model (ANCOVA). Treatment was a fixed effect within the model and the log(amplitude) at baseline was included as a covariate.||0.2781|-0.1576|
72367936|NCT01821118|144245799|SUPERIORITY_OR_OTHER||Estimated Treatment Difference (log e)|-0.0859|STANDARD_ERROR_OF_MEAN|0.1165|||TWO_SIDED|90.0|-0.2843|0.1124||||||ROI1, Day 90: Analysis of the change from baseline in log(amplitude) was carried out using a linear model (ANCOVA). Treatment was a fixed effect within the model and the log(amplitude) at baseline was included as a covariate.||0.1124|-0.2843|
72367937|NCT01821118|144245799|SUPERIORITY_OR_OTHER||Estimated Treatment Difference (log e)|-0.0488|STANDARD_ERROR_OF_MEAN|0.0902|||TWO_SIDED|90.0|-0.2018|0.1042||||||ROI2, Day 2: Analysis of the change from baseline in log(amplitude) was carried out using a linear model (ANCOVA). Treatment was a fixed effect within the model and the log(amplitude) at baseline was included as a covariate.||0.1042|-0.2018|
72367938|NCT01821118|144245799|SUPERIORITY_OR_OTHER||Estimated Treatment Difference (log e)|-0.0888|STANDARD_ERROR_OF_MEAN|0.1061|||TWO_SIDED|90.0|-0.2689|0.0914||||||ROI2, Day 90: Analysis of the change from baseline in log(amplitude) was carried out using a linear model (ANCOVA). Treatment was a fixed effect within the model and the log(amplitude) at baseline was included as a covariate.||0.0914|-0.2689|
72367939|NCT01821118|144245800|SUPERIORITY_OR_OTHER||Estimated Treatment Difference (log e)|0.0464|STANDARD_ERROR_OF_MEAN|0.0395|||TWO_SIDED|90.0|-0.0207|0.1136||||||ROI1, Day 2: Analysis of the change from baseline in log(time to return to baseline) was carried out using a linear model (ANCOVA). Treatment was a fixed effect within the model and the log(time to return to baseline) at baseline was included as a covariate.||0.1136|-0.0207|
72367940|NCT01821118|144245800|SUPERIORITY_OR_OTHER||Estimated Treatment Difference (log e)|0.0737|STANDARD_ERROR_OF_MEAN|0.0383|||TWO_SIDED|90.0|0.0084|0.139||||||ROI1, Day 90: Analysis of the change from baseline in log(time to return to baseline) was carried out using a linear model (ANCOVA). Treatment was a fixed effect within the model and the log(time to return to baseline) at baseline was included as a covariate.||0.1390|0.0084|
72367941|NCT01821118|144245800|SUPERIORITY_OR_OTHER||Estimated Treatment Difference (log e)|0.0219|STANDARD_ERROR_OF_MEAN|0.0337|||TWO_SIDED|90.0|-0.0352|0.079||||||ROI2, Day 2: Analysis of the change from baseline in log(time to return to baseline) was carried out using a linear model (ANCOVA). Treatment was a fixed effect within the model and the log(time to return to baseline) at baseline was included as a covariate.||0.0790|-0.0352|
72367942|NCT01821118|144245800|SUPERIORITY_OR_OTHER||Estimated Treatment Difference (log e)|0.0117|STANDARD_ERROR_OF_MEAN|0.034|||TWO_SIDED|90.0|-0.046|0.0694||||||ROI2, Day 90: Analysis of the change from baseline in log(time to return to baseline) was carried out using a linear model (ANCOVA). Treatment was a fixed effect within the model and the log(time to return to baseline) at baseline was included as a covariate.||0.0694|-0.0460|
72367943|NCT00643162|144245881|OTHER||Mean Difference (Final Values)|2.3|STANDARD_DEVIATION|6.15||0.68|TWO_SIDED||||||t-test, 2 sided|||||||.68
72367944|NCT02691507|144245884|SUPERIORITY_OR_OTHER||||||<|0.001||||||The significance level threshold level was 0.05.|Paired t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||<0.001
72367945|NCT02691507|144245884|SUPERIORITY_OR_OTHER|||||||0.002||||||The significance level threshold level was 0.05.|Paired t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||0.002
72367946|NCT02691507|144245884|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.4|STANDARD_ERROR_OF_MEAN|0.795||0.616|TWO_SIDED|95.0|-1.196|1.998||The significance level threshold level was 0.05.|ANCOVA|Change from baseline as response, baseline score as covariate and treatment as factor.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.998|-1.196|0.616
72367947|NCT02691507|144245885|SUPERIORITY_OR_OTHER||||||<|0.001||||||The significance level threshold level was 0.05.|Paired t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||<0.001
72367948|NCT02691507|144245885|SUPERIORITY_OR_OTHER||||||<|0.001||||||The significance level threshold level was 0.05.|Paired t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||<0.001
72367949|NCT02691507|144245885|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.85|STANDARD_ERROR_OF_MEAN|0.803||0.297|TWO_SIDED|95.0|-0.767|2.46||The significance level threshold level was 0.05.|ANCOVA|Change from baseline as response, baseline score as covariate and treatment as factor.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||2.460|-0.767|0.297
72367950|NCT02691507|144245886|SUPERIORITY_OR_OTHER||||||<|0.001||||||The significance level threshold level was 0.05.|Paired t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||<0.001
72367951|NCT02691507|144245886|SUPERIORITY_OR_OTHER||||||<|0.001||||||The significance level threshold level was 0.05.|Paired t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||<0.001
72367952|NCT02691507|144245886|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.73|STANDARD_ERROR_OF_MEAN|0.846||0.394|TWO_SIDED|95.0|-0.973|2.426||The significance level threshold level was 0.05.|ANCOVA|Change from baseline as response, baseline score as covariate and treatment as factor.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||2.426|-0.973|0.394
72367953|NCT02691507|144245887|SUPERIORITY_OR_OTHER||||||<|0.001||||||The significance level threshold level was 0.05.|Paired t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||<0.001
72367954|NCT02691507|144245887|SUPERIORITY_OR_OTHER||||||<|0.001||||||The significance level threshold level was 0.05.|Paired t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||<0.001
72367955|NCT02691507|144245887|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.28|STANDARD_ERROR_OF_MEAN|0.708||0.69|TWO_SIDED|95.0|-1.14|1.709||The significance level threshold level was 0.05.|ANCOVA|Change from baseline as response, baseline score as covariate and treatment as factor.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.709|-1.140|0.690
72367956|NCT02691507|144245888|SUPERIORITY_OR_OTHER||||||<|0.001||||||The significance level threshold level was 0.05.|Paired t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||<0.001
72367957|NCT02691507|144245888|SUPERIORITY_OR_OTHER||||||<|0.001||||||The significance level threshold level was 0.05.|Paired t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||<0.001
72367958|NCT02691507|144245888|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.08|STANDARD_ERROR_OF_MEAN|0.735||0.914|TWO_SIDED|95.0|-1.556|1.397||The significance level threshold level was 0.05.|ANCOVA|Change from baseline as response, baseline score as covariate and treatment as factor.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.397|-1.556|0.914
72367959|NCT02691507|144245889|SUPERIORITY_OR_OTHER||||||<|0.001||||||The significance level threshold level was 0.05.|Paired t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||<0.001
72367960|NCT02691507|144245889|SUPERIORITY_OR_OTHER||||||<|0.001||||||The significance level threshold level was 0.05.|Paired t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||<0.001
72367961|NCT02691507|144245889|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.24|STANDARD_ERROR_OF_MEAN|0.774||0.757|TWO_SIDED|95.0|-1.796|1.314||The significance level threshold level was 0.05.|ANCOVA|Change from baseline as response, baseline score as covariate and treatment as factor.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.314|-1.796|0.757
72367962|NCT02691507|144245890|SUPERIORITY_OR_OTHER||||||<|0.001||||||The significance level threshold level was 0.05.|Paired t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||<0.001
72367963|NCT02691507|144245890|SUPERIORITY_OR_OTHER||||||<|0.001||||||The significance level threshold level was 0.05.|Paired t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||<0.001
72367964|NCT02691507|144245890|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.47|STANDARD_ERROR_OF_MEAN|0.798||0.556|TWO_SIDED|95.0|-2.075|1.129||The significance level threshold level was 0.05.|ANCOVA|Change from baseline as response, baseline score as covariate and treatment as factor.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.129|-2.075|0.556
72367965|NCT02691507|144245891|SUPERIORITY_OR_OTHER||||||<|0.001||||||The significance level threshold level was 0.05.|Paired t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||<0.001
72367966|NCT02691507|144245891|SUPERIORITY_OR_OTHER||||||<|0.001||||||The significance level threshold level was 0.05.|Paired t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||<0.001
72367967|NCT02691507|144245891|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.27|STANDARD_ERROR_OF_MEAN|0.772||0.106|TWO_SIDED|95.0|-2.824|0.278||The significance level threshold level was 0.05.|ANCOVA|Change from baseline as response, baseline score as covariate and treatment as factor.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.278|-2.824|0.106
72367968|NCT02691507|144245892|SUPERIORITY_OR_OTHER||||||<|0.001||||||The significance level threshold level was 0.05.|Paired t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||<0.001
72367969|NCT02691507|144245892|SUPERIORITY_OR_OTHER||||||<|0.001||||||The significance level threshold level was 0.05.|Paired t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||<0.001
72367970|NCT02691507|144245892|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|26.83|STANDARD_ERROR_OF_MEAN|6.681|<|0.001|TWO_SIDED|95.0|13.407|40.247||The significance level threshold level was 0.05.|ANCOVA|Change from baseline as response, baseline score as covariate and treatment as factor.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||40.247|13.407|<0.001
72367971|NCT02691507|144245893|SUPERIORITY_OR_OTHER||||||<|0.001||||||The significance level threshold level was 0.05.|Paired t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||<0.001
72367972|NCT02691507|144245893|SUPERIORITY_OR_OTHER|||||||0.004||||||The significance level threshold level was 0.05.|Paired t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||0.004
72367973|NCT02691507|144245893|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|19.33|STANDARD_ERROR_OF_MEAN|3.996|<|0.001|TWO_SIDED|95.0|11.301|27.352||The significance level threshold level was 0.05.|ANCOVA|Change from baseline as response, baseline score as covariate and treatment as factor.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||27.352|11.301|<0.001
72367974|NCT02691507|144245894|SUPERIORITY_OR_OTHER||||||<|0.001||||||The significance level threshold level was 0.05.|Paired t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||<0.001
72367975|NCT02691507|144245894|SUPERIORITY_OR_OTHER|||||||0.009||||||The significance level threshold level was 0.05.|Paired t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||0.009
72367976|NCT02691507|144245894|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.01|STANDARD_ERROR_OF_MEAN|4.072|<|0.001|TWO_SIDED|95.0|7.829|24.187||The significance level threshold level was 0.05.|ANCOVA|Change from baseline as response, baseline score as covariate and treatment as factor.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||24.187|7.829|<0.001
72367977|NCT02691507|144245895|SUPERIORITY_OR_OTHER||||||<|0.001||||||The significance level threshold level was 0.05.|Paired t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||<0.001
72367978|NCT02691507|144245895|SUPERIORITY_OR_OTHER|||||||0.003||||||The significance level threshold level was 0.05.|Paired t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||0.003
72367979|NCT02691507|144245895|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.25|STANDARD_ERROR_OF_MEAN|3.764|<|0.001|TWO_SIDED|95.0|5.684|20.82||The significance level threshold level was 0.05.|ANCOVA|Change from baseline as response, baseline score as covariate and treatment as factor.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||20.820|5.684|<0.001
72367980|NCT02691507|144245896|SUPERIORITY_OR_OTHER||||||<|0.001||||||The significance level threshold level was 0.05.|Paired t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||<0.001
72367981|NCT02691507|144245896|SUPERIORITY_OR_OTHER|||||||0.049||||||The significance level threshold level was 0.05.|Paired t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||0.049
72367982|NCT02691507|144245896|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.08|STANDARD_ERROR_OF_MEAN|4.138||0.001|TWO_SIDED|95.0|5.766|22.387||The significance level threshold level was 0.05.|ANCOVA|Change from baseline as response, baseline score as covariate and treatment as factor.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||22.387|5.766|0.001
72367983|NCT02691507|144245897|SUPERIORITY_OR_OTHER||||||<|0.001||||||The significance level threshold level was 0.05.|Paired t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||<0.001
72367984|NCT02691507|144245897|SUPERIORITY_OR_OTHER|||||||0.024||||||The significance level threshold level was 0.05.|Paired t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||0.024
72367985|NCT02691507|144245897|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.26|STANDARD_ERROR_OF_MEAN|4.679||0.004|TWO_SIDED|95.0|4.862|23.66||The significance level threshold level was 0.05.|ANCOVA|Change from baseline as response, baseline score as covariate and treatment as factor.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||23.660|4.862|0.004
72367986|NCT02691507|144245898|SUPERIORITY_OR_OTHER||||||<|0.001||||||The significance level threshold level was 0.05.|Paired t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||<0.001
72367987|NCT02691507|144245898|SUPERIORITY_OR_OTHER|||||||0.015||||||The significance level threshold level was 0.05.|Paired t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||0.015
72367988|NCT02691507|144245898|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.77|STANDARD_ERROR_OF_MEAN|4.222||0.004|TWO_SIDED|95.0|4.291|21.252||The significance level threshold level was 0.05.|ANCOVA|Change from baseline as response, baseline score as covariate and treatment as factor.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||21.252|4.291|0.004
72367989|NCT02691507|144245899|SUPERIORITY_OR_OTHER||||||<|0.001||||||The significance level threshold level was 0.05.|Paired t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||<0.001
72367990|NCT02691507|144245899|SUPERIORITY_OR_OTHER|||||||0.034||||||The significance level threshold level was 0.05.|Paired t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||0.034
72367991|NCT02691507|144245899|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.71|STANDARD_ERROR_OF_MEAN|5.925||0.037|TWO_SIDED|95.0|0.805|24.621||The significance level threshold level was 0.05.|ANCOVA|Change from baseline as response, baseline score as covariate and treatment as factor.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||24.621|0.805|0.037
72367992|NCT04634253|144245954|SUPERIORITY||LS Mean|-0.88|STANDARD_ERROR_OF_MEAN|0.361||0.017|TWO_SIDED|95.0|-1.6|-0.16|||Mixed Models Analysis|||||-0.16|-1.60|0.017
72367993|NCT04634253|144245954|SUPERIORITY||LS Mean|-1.09|STANDARD_ERROR_OF_MEAN|0.32|<|0.001|TWO_SIDED|95.0|-1.73|-0.46|||Mixed Models Analysis|||||-0.46|-1.73|<0.001
72367994|NCT04634253|144245955|SUPERIORITY||Odds Ratio (OR)|1.0||||0.997|TWO_SIDED|95.0|0.29|3.44|||Regression, Logistic|||||3.44|0.29|0.997
72367995|NCT04634253|144245955|SUPERIORITY||Odds Ratio (OR)|3.4||||0.032|TWO_SIDED|95.0|1.11|10.4|||Regression, Logistic|||||10.40|1.11|0.032
72367996|NCT04634253|144245956|SUPERIORITY||Odds Ratio (OR)|0.29||||0.235|TWO_SIDED|95.0|0.04|2.25|||Regression, Logistic|||||2.25|0.04|0.235
72367997|NCT04634253|144245956|SUPERIORITY||Odds Ratio (OR)|1.37||||0.661|TWO_SIDED|95.0|0.33|5.61|||Regression, Logistic|||||5.61|0.33|0.661
72367998|NCT04634253|144245957|SUPERIORITY||Odds Ratio (OR)|0.97||||0.965|TWO_SIDED|95.0|0.22|4.28|||Regression, Logistic|||||4.28|0.22|0.965
72367999|NCT04634253|144245957|SUPERIORITY||Odds Ratio (OR)|2.91||||0.098|TWO_SIDED|95.0|0.82|10.33|||Regression, Logistic|||||10.33|0.82|0.098
72368000|NCT04634253|144245958|SUPERIORITY||LS Mean Difference|-11.26|STANDARD_ERROR_OF_MEAN|3.71||0.003|TWO_SIDED|95.0|-18.65|-3.87|||Mixed Models Analysis|||||-3.87|-18.65|0.003
72368001|NCT04634253|144245958|SUPERIORITY||LS Mean Difference|-13.1|STANDARD_ERROR_OF_MEAN|3.265|<|0.001|TWO_SIDED|95.0|-19.61|-6.6|||Mixed Models Analysis|||||-6.60|-19.61|<0.001
72368002|NCT04634253|144245959|SUPERIORITY||LS Mean Difference|-10.3|STANDARD_ERROR_OF_MEAN|3.782||0.008|TWO_SIDED|95.0|-17.83|-2.77|||Mixed Models Analysis|||||-2.77|-17.83|0.008
72368003|NCT04634253|144245959|SUPERIORITY||LS Mean Difference|-11.76|STANDARD_ERROR_OF_MEAN|3.282|<|0.001|TWO_SIDED|95.0|-18.29|-5.22|||Mixed Models Analysis|||||-5.22|-18.29|<0.001
72368004|NCT04634253|144245960|SUPERIORITY||LS Mean Difference|-2.93|STANDARD_ERROR_OF_MEAN|2.365||0.218|TWO_SIDED|95.0|-7.63|1.77|||ANCOVA|||Mental Component Score (MCS)||1.77|-7.63|0.218
72368005|NCT04634253|144245960|SUPERIORITY||LS Mean Difference|1.15|STANDARD_ERROR_OF_MEAN|2.065||0.578|TWO_SIDED|95.0|-2.95|5.26|||ANCOVA|||Mental Component Score (MCS)||5.26|-2.95|0.578
72368006|NCT04634253|144245960|SUPERIORITY||LS Mean Difference|2.02|STANDARD_ERROR_OF_MEAN|2.368||0.396|TWO_SIDED|95.0|-2.69|6.73|||ANCOVA|||Physical Component Score (PCS)||6.73|-2.69|0.396
72368007|NCT04634253|144245960|SUPERIORITY||LS Mean Difference|1.42|STANDARD_ERROR_OF_MEAN|2.057||0.493|TWO_SIDED|95.0|-2.67|5.5|||ANCOVA|||Physical Component Score (PCS)||5.50|-2.67|0.493
72368008|NCT01356277|144245975|SUPERIORITY||Odds Ratio (OR)|1.66||||0.006|TWO_SIDED|95.0|1.15|2.39|||Regression, Logistic|Unadjusted, ordinal logistic regression|An odds ratio greater than 1.0 indicates higher adherence in Intervention participants compared with controls.|We estimated a sample size of 75 participants per group to have 85% power to detect a 20% difference in taking adherence between groups, using 2-sided tests and setting alpha at 0.05, assuming a common standard deviation of 40%. Targeted enrollment of 176 participants accounted for 15% drop-out. Only participants with electronic pillbox data could be included. For participants who withdrew or stopped using the pillbox, all available pillbox data were included.||2.39|1.15|0.006
72368009|NCT01356277|144245976|SUPERIORITY||Odds Ratio (OR)|1.74||||0.003|TWO_SIDED|95.0|1.21|2.5|||Regression, Logistic|Unadjusted ordinal logistic regression|An odds ratio greater than 1.0 indicates higher adherence in Intervention participants compared with controls.|||2.50|1.21|0.003
72368010|NCT01356277|144245977|SUPERIORITY|||||||0.49|||||||Wilcoxon ranksum|||Null hypothesis was that there was no difference in the SD of tacrolimus trough levels between intervention and control.||||0.49
72368011|NCT01356277|144245978|SUPERIORITY|||||||0.15|||||||t-test, 2 sided|||||||0.15
72368012|NCT01356277|144245979|SUPERIORITY|||||||0.15|||||||t-test, 2 sided|||||||0.15
72368013|NCT01356277|144245980|SUPERIORITY|||||||0.26|||||||Chi-squared|||Rates were compared between intervention and control groups using Chi square||||0.26
72368014|NCT01356277|144245981|SUPERIORITY|||||||0.45|||||||t-test, 2 sided|||||||.45
72368015|NCT02721966|144245984|SUPERIORITY||Odds Ratio (OR)|4.37|||<|0.0001|TWO_SIDED|95.0|2.72|7.01|||Regression, Logistic|95% confidence interval for odds ratio||"Up to week 12, all participants in the group placebo AIN457 took placebo only"||7.01|2.72|<.0001
72368016|NCT02721966|144245984|SUPERIORITY||Odds Ratio (OR)|3.83|||<|0.0001|TWO_SIDED|95.0|2.41|6.1|||Regression, Logistic|95% confidence interval for odds ratio||"Up to week 12, all participants in the group placebo AIN457 took placebo only"||6.10|2.41|<.0001
72368017|NCT02721966|144245985|SUPERIORITY||Odds Ratio (OR)|4.37|||<|0.0001|TWO_SIDED|95.0|2.72|7.01|||Regression, Logistic|95% confidence interval for odds ratio||"Up to week 12, all participants in the group placebo AIN457 took placebo only"||7.01|2.72|<.0001
72368018|NCT02721966|144245986|SUPERIORITY||Odds Ratio (OR)|4.71|||<|0.0001|TWO_SIDED|95.0|2.67|8.33|||Regression, Logistic|95% confidence interval for odds ratio|||Odds ratio, 95% CI for odds ratio, and p-value are from a logistic regression model with treatment (3 treatment groups), methotrexate usage status (yes, no) as explanatory variables|8.33|2.67|<.0001
72368019|NCT02721966|144245986|SUPERIORITY||Odds Ratio (OR)|5.61|||<|0.0001|TWO_SIDED|95.0|3.2|9.84|||Regression, Logistic|95% confidence interval for odds ratio|||Odds ratio, 95% CI for odds ratio, and p-value are from a logistic regression model with treatment (3 treatment groups), methotrexate usage status (yes, no) as explanatory variables|9.84|3.20|<.0001
72368020|NCT02721966|144245987|SUPERIORITY||Odds Ratio (OR)|4.5|||<|0.0001|TWO_SIDED|95.0|2.43|8.33|||Regression, Logistic|95% confidence interval for odds ratio||"Up to week 12, all participants in the group placebo AIN457 took placebo only"|Odds ratio, 95% CI for odds ratio, and p-value are from a logistic regression model with treatment (3 treatment groups), methotrexate usage status (yes, no) as explanatory variables|8.33|2.43|<.0001
72368021|NCT02721966|144245987|SUPERIORITY||Odds Ratio (OR)|5.57|||<|0.0001|TWO_SIDED|95.0|3.04|10.21|||Regression, Logistic|95% confidence interval for odds ratio||"Up to week 12, all participants in the group placebo AIN457 took placebo only"|Odds ratio, 95% CI for odds ratio, and p-value are from a logistic regression model with treatment (3 treatment groups), methotrexate usage status (yes, no) as explanatory variables|10.21|3.04|<.0001
72368022|NCT02721966|144245988|SUPERIORITY||LS Mean of Treatment Difference|-14.9|STANDARD_ERROR_OF_MEAN|2.62|<|0.0001|TWO_SIDED|95.0|-20.0|-9.7|||ANCOVA||||Least squares (LS) mean, LS mean treatment difference, 95% confidence interval (CI) for treatment difference, and p-value are from MMRM (mixed model for repeated measures) with treatment group, visit, treatment\*visit, baseline\*visit and concomitant MTX intake status, as factors and baseline measurement in VAS as continuous covariate|-9.7|-20.0|<.0001
72368023|NCT02721966|144245988|SUPERIORITY||LS Mean of Treatment Difference|-12.9|STANDARD_ERROR_OF_MEAN|2.59|<|0.0001|TWO_SIDED|95.0|-18.0|-7.8|||ANCOVA||||Least squares (LS) mean, LS mean treatment difference, 95% confidence interval (CI) for treatment difference, and p-value are from MMRM (mixed model for repeated measures) with treatment group, visit, treatment\*visit, baseline\*visit and concomitant MTX intake status, as factors and baseline measurement in VAS as continuous covariate|-7.8|-18.0|<.0001
72368024|NCT02721966|144245989|SUPERIORITY||LS Mean of Treatment Difference|-15.1|STANDARD_ERROR_OF_MEAN|2.71|<|0.0001|TWO_SIDED|95.0|-20.4|-9.7|||ANCOVA|||"Up to week 12, all participants in the group placebo AIN457 took placebo only"|Least squares (LS) mean, LS mean treatment difference, 95% confidence interval (CI) for treatment difference, and p-value are from MMRM (mixed model for repeated measures) with treatment group, visit, treatment\*visit, baseline\*visit and concomitant MTX intake status, as factors and baseline measurement in VAS as continuous covariate|-9.7|-20.4|<.0001
72368025|NCT02721966|144245989|SUPERIORITY||LS Mean of Treatment Difference|-15.0|STANDARD_ERROR_OF_MEAN|2.68|<|0.0001|TWO_SIDED|95.0|-20.3|-9.8|||ANCOVA|||"Up to week 12, all participants in the group placebo AIN457 took placebo only"|Least squares (LS) mean, LS mean treatment difference, 95% confidence interval (CI) for treatment difference, and p-value are from MMRM (mixed model for repeated measures) with treatment group, visit, treatment\*visit, baseline\*visit and concomitant MTX intake status, as factors and baseline measurement in VAS as continuous covariate|-9.8|-20.3|<.0001
72368026|NCT02721966|144245990|SUPERIORITY||LS Mean of Treatment Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.3||0.0971|TWO_SIDED|95.0|-1.1|0.1|||ANCOVA||||Least squares (LS) mean, LS mean treatment difference, 95% confidence interval (CI) for treatment difference, and p-value are from MMRM (mixed model for repeated measures) with treatment group, visit, treatment\*visit, baseline\*visit and concomitant MTX intake status, as factors and baseline SPARCC index as continuous covariate.|0.1|-1.1|0.0971
72368027|NCT02721966|144245990|SUPERIORITY||LS Mean of Treatment Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.3||0.0207|TWO_SIDED|95.0|-1.3|-0.1|||ANCOVA||||Least squares (LS) mean, LS mean treatment difference, 95% confidence interval (CI) for treatment difference, and p-value are from MMRM (mixed model for repeated measures) with treatment group, visit, treatment\*visit, baseline\*visit and concomitant MTX intake status, as factors and baseline measurement in VAS as continuous covariate|-0.1|-1.3|0.0207
72368028|NCT02721966|144245991|SUPERIORITY||LS Mean of Treatment Difference|-0.175|STANDARD_ERROR_OF_MEAN|0.0502||0.0005|TWO_SIDED|95.0|-0.273|-0.076|||ANCOVA||||Least squares (LS) mean, LS mean treatment difference, 95% confidence interval (CI) for treatment difference, and p-value are from MMRM (mixed model for repeated measures) with treatment group, visit, treatment\*visit, baseline\*visit and concomitant MTX intake status, as factors and baseline HAQ-DI index as continuous covariate|-0.076|-0.273|0.0005
72368029|NCT02721966|144245991|SUPERIORITY||LS Mean of Treatment Difference|-0.234|STANDARD_ERROR_OF_MEAN|0.0497|<|0.0001|TWO_SIDED|95.0|-0.331|-0.136|||ANCOVA||||Least squares (LS) mean, LS mean treatment difference, 95% confidence interval (CI) for treatment difference, and p-value are from MMRM (mixed model for repeated measures) with treatment group, visit, treatment\*visit, baseline\*visit and concomitant MTX intake status, as factors and baseline HAQ-DI index as continuous covariate|-0.136|-0.331|<.0001
72368030|NCT02721966|144245992|SUPERIORITY||LS Mean of Treatment Difference|3.8|STANDARD_ERROR_OF_MEAN|1.01||0.0002|TWO_SIDED|95.0|1.8|5.7|||ANCOVA|||week 12|Least squares (LS) mean, LS mean treatment difference, 95% confidence interval (CI) for treatment difference, and p-value are from MMRM (mixed model for repeated measures) with treatment group, visit, treatment\*visit, baseline\*visit and concomitant MTX intake status, as factors and baseline FACIT Fatigue© score as continuous covariate|5.7|1.8|0.0002
72368031|NCT02721966|144245992|SUPERIORITY||LS Mean of Treatment Difference|3.4|STANDARD_ERROR_OF_MEAN|0.99||0.0007|TWO_SIDED|95.0|1.4|5.3|||ANCOVA|||week 12|Least squares (LS) mean, LS mean treatment difference, 95% confidence interval (CI) for treatment difference, and p-value are from MMRM (mixed model for repeated measures) with treatment group, visit, treatment\*visit, baseline\*visit and concomitant MTX intake status, as factors and baseline FACIT Fatigue© score as continuous covariate|5.3|1.4|0.0007
72368032|NCT02721966|144245993|SUPERIORITY||LS Mean of Treatment Difference|-1.7|STANDARD_ERROR_OF_MEAN|0.41|<|0.0001|TWO_SIDED|95.0|-2.5|-0.9|||ANCOVA|||"Up to week 12, all participants in the group placebo AIN457 took placebo only"|Least squares (LS) mean, LS mean treatment difference, 95% confidence interval (CI) for treatment difference, and p-value are from MMRM (mixed model for repeated measures) with treatment group,visit, treatment\*visit, baseline\*visit and concomitant MTX intake status, as factors and baseline ASAS health index as continuous covariate.|-0.9|-2.5|<.0001
72368033|NCT02721966|144245993|SUPERIORITY||LS Mean of Treatment Difference|-1.7|STANDARD_ERROR_OF_MEAN|0.4|<|0.0001|TWO_SIDED|95.0|-2.4|-0.9|||ANCOVA|||"Up to week 12, all participants in the group placebo AIN457 took placebo only"|Least squares (LS) mean, LS mean treatment difference, 95% confidence interval (CI) for treatment difference, and p-value are from MMRM (mixed model for repeated measures) with treatment group,visit, treatment\*visit, baseline\*visit and concomitant MTX intake status, as factors and baseline ASAS health index as continuous covariate.|-0.9|-2.4|<.0001
72368034|NCT02721966|144245994|SUPERIORITY||Odds Ratio (OR)|5.74|||<|0.0001|TWO_SIDED|95.0|3.31|9.95|||Regression, Logistic|95% confidence interval for odds ratio|||"Odds ratio, 95% CI for odds ratio, and p-value are from a logistic regression model with treatment (3 treatment groups), methotrexate usage status (yes, no) as explanatory variables.~Missing ACR20 response variables were imputed by multiple imputation approach"|9.95|3.31|<.0001
72368035|NCT02721966|144245994|SUPERIORITY||Odds Ratio (OR)|4.8|||<|0.0001|TWO_SIDED|95.0|2.83|8.16|||Regression, Logistic|95% confidence interval for odds ratio|||"Odds ratio, 95% CI for odds ratio, and p-value are from a logistic regression model with treatment (3 treatment groups), methotrexate usage status (yes, no) as explanatory variables.~Missing ACR20 response variables were imputed by multiple imputation approach"|8.16|2.83|<.0001
72368036|NCT00607373|144245998|SUPERIORITY_OR_OTHER||||||<|0.001||||||Statistical significance was concluded if p≤0.05|t-test, 2 sided|||Based upon prior clinical study experience with mipomersen, it was estimated that the standard deviation of the percent change in LDL-C is approximately 22%. With 15 patients in the control group and 30 patients in the mipomersen-treated group, this study would have at least 80% power to detect a 20 percentage point difference between the 2 treatment groups. Fifty-one patients were enrolled to allow for patient withdrawals and potential exclusions from analysis sets.||||<0.001
72368037|NCT00607373|144245999|SUPERIORITY_OR_OTHER||||||<|0.001||||||Inflation of type 1 error was controlled by specifying a small number of secondary parameters and a sequential inferential approach in which inferential conclusions about each successive parameter required statistical significance of the prior one.|t-test, 2 sided|||||||<0.001
72368038|NCT00607373|144246001|SUPERIORITY_OR_OTHER||||||<|0.001||||||Inferential conclusions about this parameter require statistical significance of the previous secondary outcome measure (i.e., percent change from baseline in Apo B at PET).|t-test, 2 sided|||||||<0.001
72368039|NCT00607373|144246004|SUPERIORITY_OR_OTHER||||||<|0.001||||||Inferential conclusions about this parameter require statistical significance of the previous secondary outcome measure (i.e., percent change from baseline in total cholesterol at PET).|t-test, 2 sided|||||||<0.001
72368040|NCT00607373|144246006|SUPERIORITY_OR_OTHER|||||||0.013||||||Statistical significance was concluded if p ≤0.05|Wilcoxon rank sum test|||||||0.013
72368041|NCT00607373|144246008|SUPERIORITY_OR_OTHER|||||||0.001||||||Statistical significance was concluded if p ≤0.05|t-test, 2 sided|||||||0.001
72368042|NCT00607373|144246010|SUPERIORITY_OR_OTHER|||||||0.009||||||Statistical significance was concluded if p ≤0.05|Wilcoxon rank sum test|||||||0.009
72368043|NCT00607373|144246012|SUPERIORITY_OR_OTHER||||||<|0.001||||||Statistical significance was concluded if p ≤0.05|t-test, 2 sided|||||||<0.001
72368044|NCT00607373|144246014|SUPERIORITY_OR_OTHER|||||||0.328||||||Statistical significance was concluded if p ≤0.05|t-test, 2 sided|||||||0.328
72368045|NCT00607373|144246016|SUPERIORITY_OR_OTHER|||||||0.035||||||Statistical significance was concluded if p ≤0.05|Wilcoxon rank sum test|||||||0.035
72368046|NCT01724346|144246021|SUPERIORITY||Hazard Ratio (HR)|0.155|||<|0.0001|TWO_SIDED|95.0|0.11|0.22||P-value is from stratified log-rank test.|Log Rank|||||0.220|0.110|< 0.0001
72368047|NCT01724346|144246024|SUPERIORITY||Hazard Ratio (HR)|0.087|||<|0.0001|TWO_SIDED|95.0|0.054|0.141||P value is from stratified log-rank test.|Log Rank|||||0.141|0.054|< 0.0001
72368048|NCT01724346|144246025|SUPERIORITY||Rate ratio|2.496|||<|0.0001|TWO_SIDED|95.0|1.99|3.131||Rate ratio and p-value are based on Cochran-Mantel-Haenszel chi-square test stratified by Eastern Cooperative Oncology Group (ECOG; 0-1 vs 2) and Rai stage (0/I/II vs III/IV) at baseline.|Cochran-Mantel-Haenszel|||||3.131|1.990|< 0.0001
72368049|NCT02876601|144246028|SUPERIORITY|||||||0.408|||||||Wilcoxon (Mann-Whitney)|||||||0.408
72368050|NCT02876601|144246029|SUPERIORITY|||||||0.148|||||||Wilcoxon (Mann-Whitney)|||||||0.148
72368051|NCT02876601|144246030|SUPERIORITY|||||||0.039|||||||Wilcoxon (Mann-Whitney)|||||||0.039
72368052|NCT02876601|144246031|SUPERIORITY|||||||0.642|||||||Wilcoxon (Mann-Whitney)|||||||0.642
72368053|NCT02876601|144246032|SUPERIORITY|||||||0.026|||||||Wilcoxon (Mann-Whitney)|||||||0.026
72368054|NCT02876601|144246033|SUPERIORITY|||||||0.326|||||||Wilcoxon (Mann-Whitney)|||||||0.326
72368055|NCT02876601|144246034|SUPERIORITY|||||||0.796|||||||Wilcoxon (Mann-Whitney)|||||||0.796
72368056|NCT02876601|144246035|SUPERIORITY|||||||0.918|||||||Wilcoxon (Mann-Whitney)|||||||0.918
72368057|NCT02876601|144246036|SUPERIORITY|||||||0.877|||||||Wilcoxon (Mann-Whitney)|||||||0.877
72368058|NCT02876601|144246037|SUPERIORITY|||||||0.423|||||||Wilcoxon (Mann-Whitney)|||||||0.423
72368059|NCT02876601|144246038|SUPERIORITY|||||||0.938|||||||Wilcoxon (Mann-Whitney)|||||||0.938
72368060|NCT00256997|144246039|SUPERIORITY_OR_OTHER|||||||0.5498||||||P-value was calculated by Cox proportional hazard model stratified for positive and negative symptom scale.|Cox proportional hazard model|||||||0.5498
72368061|NCT05232682|144246050|OTHER||F-test|2.41||||0.1183|TWO_SIDED|||||Alpha value for significance set at p \< .05.|Mixed Models Analysis|||||||0.1183
72368062|NCT05232682|144246051|OTHER||F-test|0.07||||0.9308|TWO_SIDED|||||Alpha value for significance set at p \< .05.|Mixed Models Analysis|||||||0.9308
72368063|NCT05232682|144246052|OTHER||F-test|2.1||||0.1517|TWO_SIDED|||||Alpha value for significance set at p \< .05.|Mixed Models Analysis|||||||0.1517
72368064|NCT05232682|144246053|OTHER||F-test|0.14||||0.8747|TWO_SIDED|||||Alpha value for significance set at p \< .05.|Mixed Models Analysis|||||||0.8747
72368065|NCT05232682|144246054|OTHER||F-test|1.19||||0.3269|TWO_SIDED|||||Alpha value for significance set at p \< .05.|Mixed Models Analysis|||||||0.3269
72368066|NCT05232682|144246055|OTHER||F-test|1.14||||0.3411|TWO_SIDED|||||Alpha value for significance set at p \< .05.|Mixed Models Analysis|||||||0.3411
72368067|NCT02819011|144246067|SUPERIORITY|||||||0.04||||||priori threshold for statistical significance= 0.05|Mixed Models Analysis|||Repeated measures to compare changes in two groups from baseline to 6 months||||0.040
72368068|NCT02819011|144246068|SUPERIORITY|||||||0.005||||||a priori threshold for statistical significance = 0.05|Mixed Models Analysis|||Repeated measures to compare the changes in both groups from baseline to 6 months||||0.005
72368069|NCT02819011|144246069|SUPERIORITY|||||||0.019||||||a priori threshold for statistical significance = 0.05|Mixed Models Analysis|||Repeated measures to compare the changes in both groups from baseline to 6 months||||0.019
72368070|NCT02819011|144246071|SUPERIORITY|||||||0.572||||||priori threshold for statistical significance = 0.05|Generalized Estimating Equations|||Repeated measures to compare the changes of both groups from pre-intervention to post-intervention year.||||0.572
72368071|NCT02819011|144246072|SUPERIORITY|||||||0.65||||||a priori threshold for statistical significance = 0.05|Mixed Models Analysis|||Repeated measures to compare the changes between groups from baseline to 6 months||||0.650
72368072|NCT02819011|144246073|SUPERIORITY|||||||0.756||||||a priori threshold for statistical significance = 0.05|Mixed Models Analysis|||Repeated measures to compare the changes between groups from baseline to 6 months||||0.756
72368073|NCT02819011|144246076|SUPERIORITY|||||||0.769||||||a priori threshold for statistical significance = 0.05|Mixed Models Analysis|||Repeated measures to compare the changes between groups from baseline to 6 months||||0.769
72368074|NCT02819011|144246077|SUPERIORITY|||||||0.857||||||a priori threshold for statistical significance = 0.05|Mixed Models Analysis|||Repeated measures to compare the changes between groups from baseline to 6 months||||0.857
72368075|NCT02819011|144246078|SUPERIORITY|||||||0.829||||||a priori threshold for statistical significance = 0.05|Mixed Models Analysis|||Repeated measures to compare the changes between groups from baseline to 6 months||||0.829
72368076|NCT04953728|144246105|SUPERIORITY|||||||0.77306724|||||||t-test, 2 sided|||Change in maximum tolerance in mmHg of the rectum during ST36 100Hz when compared to baseline||||0.77306724
72368077|NCT04953728|144246105|SUPERIORITY|||||||0.24|||||||t-test, 2 sided|||Change in maximum tolerance in mmHg of the rectum during ST36 25Hz when compared to baseline||||0.24
72368078|NCT04953728|144246105|SUPERIORITY|||||||0.45|||||||t-test, 2 sided|||Change in maximum tolerance in mmHg of the rectum during PC6 100Hz when compared to baseline||||0.45
72368079|NCT04953728|144246105|SUPERIORITY|||||||0.13|||||||t-test, 2 sided|||Change in maximum tolerance in mmHg of the rectum during PC6 25Hz when compared to baseline||||0.13
72368080|NCT04953728|144246105|SUPERIORITY|||||||0.14|||||||t-test, 2 sided|||Change in maximum tolerance in mmHg of the rectum during Sham when compared to baseline||||0.14
72368081|NCT04953728|144246106|SUPERIORITY|||||||0.81019363|||||||t-test, 2 sided|||Change in average maximum tolerance of ST36 100Hz when compared to ST36 25Hz||||0.81019363
72368082|NCT04953728|144246106|SUPERIORITY|||||||0.18|||||||t-test, 2 sided|||Change in average maximum tolerance of ST36 100Hz when compared to PC6 100Hz||||0.18
72368083|NCT04953728|144246106|SUPERIORITY|||||||0.21|||||||t-test, 2 sided|||Change in average maximum tolerance of ST36 100Hz when compared to PC6 25Hz||||0.21
72368084|NCT04953728|144246106|SUPERIORITY|||||||0.58|||||||t-test, 2 sided|||Change in average maximum tolerance of ST36 100Hz when compared to Sham||||0.58
72368085|NCT04953728|144246106|SUPERIORITY|||||||0.18|||||||t-test, 2 sided|||Change in average maximum tolerance of ST36 25Hz when compared to PC6 100Hz||||0.18
72368086|NCT04953728|144246106|SUPERIORITY|||||||0.18|||||||t-test, 2 sided|||Change in average maximum tolerance of ST36 25Hz when compared to PC6 25Hz||||0.18
72368087|NCT04953728|144246106|SUPERIORITY|||||||0.78|||||||t-test, 2 sided|||Change in average maximum tolerance of ST36 25Hz when compared to sham||||0.78
72368088|NCT04953728|144246106|SUPERIORITY|||||||0.89|||||||t-test, 2 sided|||Change in average maximum tolerance of PC6 100Hz when compared to PC6 25Hz||||0.89
72368089|NCT04953728|144246106|SUPERIORITY|||||||0.05|||||||t-test, 2 sided|||Change in average maximum tolerance of PC6 100Hz when compared to sham||||0.05
72368090|NCT04953728|144246106|SUPERIORITY|||||||0.07|||||||t-test, 2 sided|||Change in average maximum tolerance of PC6 25Hz when compared to sham||||0.07
72368091|NCT04953728|144246107|SUPERIORITY|||||||0.00046998|||||||t-test, 2 sided|||ST36 100Hz: Difference of VAS sums between 15 and 50 mmHg between pre and post stimulation||||0.00046998
72368092|NCT04953728|144246107|SUPERIORITY|||||||0.74369428|||||||t-test, 2 sided|||ST36 25Hz: Difference of VAS sums between 15 and 50 mmHg between pre and post stimulation||||0.74369428
72368093|NCT04953728|144246107|SUPERIORITY|||||||0.09854383|||||||t-test, 2 sided|||PC6 100Hz: Difference of VAS sums between 15 and 50 mmHg between pre and post stimulation||||0.09854383
72368094|NCT04953728|144246107|SUPERIORITY|||||||0.24872746|||||||t-test, 2 sided|||PC6 25Hz: Difference of VAS sums between 15 and 50 mmHg between pre and post stimulation||||0.24872746
72368095|NCT04953728|144246107|SUPERIORITY|||||||0.04828889|||||||t-test, 2 sided|||Sham: Difference of VAS sums between 15 and 50 mmHg between pre and post stimulation||||0.04828889
72368096|NCT04953728|144246108|SUPERIORITY|||||||0.02|||||||t-test, 1 sided|||ST36 100Hz compared to ST36 25Hz||||0.02
72368097|NCT04953728|144246108|SUPERIORITY|||||||0.11|||||||t-test, 1 sided|||ST36 100Hz compared to PC6 100Hz||||0.11
72368098|NCT04953728|144246108|SUPERIORITY|||||||0.01|||||||t-test, 1 sided|||ST36 100Hz compared to PC6 25Hz||||0.01
72368099|NCT04953728|144246108|SUPERIORITY|||||||0.04|||||||t-test, 1 sided|||ST36 100Hz compared to Sham||||0.04
72368100|NCT04953728|144246108|SUPERIORITY|||||||0.11|||||||t-test, 1 sided|||ST36 25Hz compared to PC6 100Hz||||0.11
72368101|NCT04953728|144246108|SUPERIORITY|||||||0.23|||||||t-test, 1 sided|||ST36 25Hz compared to PC6 25Hz||||0.23
72368102|NCT04953728|144246108|SUPERIORITY|||||||0.17|||||||t-test, 1 sided|||ST36 25Hz compared to Sham||||0.17
72368103|NCT04953728|144246108|SUPERIORITY|||||||0.15|||||||t-test, 1 sided|||PC6 100Hz compared to PC6 25Hz||||0.15
72368104|NCT04953728|144246108|SUPERIORITY|||||||0.43|||||||t-test, 1 sided|||PC6 100Hz compared to Sham||||0.43
72368105|NCT04953728|144246108|SUPERIORITY|||||||0.19|||||||t-test, 1 sided|||PC6 25Hz compared to Sham||||0.19
72368106|NCT04953728|144246109|SUPERIORITY|||||||0.87|||||||t-test, 2 sided|||Change in maximum volume in mL of the rectum during ST36 100Hz when compared to baseline||||0.87
72368107|NCT04953728|144246109|SUPERIORITY|||||||0.13|||||||t-test, 2 sided|||Change in maximum volume in mL of the rectum during ST36 25Hz when compared to baseline||||0.13
72368108|NCT04953728|144246109|SUPERIORITY|||||||0.17|||||||t-test, 2 sided|||Change in maximum volume in mL of the rectum during PC6 100Hz when compared to baseline||||0.17
72368109|NCT04953728|144246109|SUPERIORITY|||||||0.88|||||||t-test, 2 sided|||Change in maximum volume in mL of the rectum during PC6 25Hz when compared to baseline||||0.88
72368110|NCT04953728|144246109|SUPERIORITY|||||||0.14|||||||t-test, 2 sided|||Change in maximum volume in mL of the rectum during sham when compared to baseline||||0.14
72368111|NCT04953728|144246110|SUPERIORITY|||||||0.007|||||||t-test, 2 sided|||Change in first sensation in mmHg of the rectum during ST36 100Hz when compared to baseline||||0.007
72368112|NCT04953728|144246110|SUPERIORITY|||||||0.83|||||||t-test, 2 sided|||Change in first sensation in mmHg of the rectum during ST36 25Hz when compared to baseline||||0.83
72368113|NCT04953728|144246110|SUPERIORITY|||||||0.87|||||||t-test, 2 sided|||Change in first sensation in mmHg of the rectum during PC6 100Hz when compared to baseline||||0.87
72368114|NCT04953728|144246110|SUPERIORITY|||||||0.004|||||||t-test, 2 sided|||Change in first sensation in mmHg of the rectum during PC6 25Hz when compared to baseline||||0.004
72368115|NCT04953728|144246110|SUPERIORITY|||||||0.056|||||||t-test, 2 sided|||Change in first sensation in mmHg of the rectum during sham when compared to baseline||||0.056
72368116|NCT05462756|144246129|NON_INFERIORITY|The sample size provided \>99% statistical power to show noninferiority assuming a 0.4% noninferiority margin (NIM), in insulin efsitora doses compared to insulin glargine, in a 1:1 randomization, a standard deviation (SD) of 1.1%, and a dropout rate of 15%.|LS Mean Difference|-0.012|||||TWO_SIDED|95.0|-0.14|0.116||||||Least Squares (LS) Mean was determined using ANCOVA model with Baseline + Country + Personal Use of CGM or FGM at Randomization + Treatment (Type III sum of squares) as variables. Missing data at Week 26 were imputed by return-to-baseline multiple imputations approach. A total of 100 datasets were imputed.||0.116|-0.140|
72368117|NCT05462756|144246130|SUPERIORITY||LS Mean Difference|-0.012||||0.855|TWO_SIDED|95.0|-0.14|0.116|||ANCOVA|||Least Squares (LS) Mean was determined using ANCOVA model with Baseline + Country + Personal Use of CGM or FGM at Randomization + Treatment (Type III sum of squares) as variables. Missing data at Week 26 were imputed by return-to-baseline multiple imputations approach. A total of 100 datasets were imputed.||0.116|-0.140|0.855
72368118|NCT05462756|144246131|SUPERIORITY||Odds Ratio (OR)|1.11||||0.504|TWO_SIDED|95.0|0.81|1.52|||Chi-squared|||||1.52|0.81|0.504
72368119|NCT05462756|144246132|SUPERIORITY||Relative rate|0.67||||0.058|TWO_SIDED|95.0|0.44|1.01|||Negative binomial model||Relative rate is the ratio of the group means (Insulin Efsitora vs Insulin Glargine).|Group mean is determined by Negative Binomial Model using Number of episodes = Baseline hypoglycemia rate + Hemoglobin A1c at Baseline (%) + Treatment, with log (exposure in days/365.25) as an offset variable.||1.01|0.44|0.058
72368120|NCT05462756|144246133|SUPERIORITY||LS Mean Difference|-4.29||||0.104|TWO_SIDED|95.0|-9.461|0.886|||ANCOVA|||LS Mean was determined using ANCOVA model using Baseline + Country + Personal Use of CGM or FGM at Randomization + Hemoglobin A1c Stratum at Baseline + Treatment (Type III sum of squares) as variables. Missing data at Baseline were imputed with multiple imputation with assumption of missing at random. Missing data at Week 26 were imputed by return-to-baseline multiple imputations approach. A total of 100 datasets were imputed with one for each of the 100 datasets imputed at Baseline.||0.886|-9.461|0.104
72368121|NCT05462756|144246134|SUPERIORITY||LS Mean Difference|1.35||||0.337|TWO_SIDED|95.0|-1.404|4.101|||ANCOVA|||LS Mean was determined using ANCOVA model using Baseline + Country + Personal Use of CGM or FGM at Randomization + Hemoglobin A1c Stratum at Baseline + Treatment (Type III sum of squares) as variables. Missing data at Baseline were imputed with multiple imputation with assumption of missing at random. Missing data at Week 22-Week 26 were imputed by return-to-baseline multiple imputations approach. A total of 100 datasets were imputed with one for each of the 100 datasets imputed at Baseline.||4.101|-1.404|0.337
72368122|NCT05462756|144246135|SUPERIORITY||LS Mean Difference|1.59||||0.104|TWO_SIDED|95.0|-0.327|3.508|||ANCOVA|||LS Mean was determined by ANCOVA model using Baseline + Country + Personal Use of CGM or FGM at Randomization + Hemoglobin A1c Stratum at Baseline + Treatment (Type III sum of squares) as variables. Missing data at Baseline were imputed with multiple imputation with assumption of missing at random. Missing data at Week 22-Week 26 were imputed by return-to-baseline multiple imputations approach. A total of 100 datasets were imputed with one for each of the 100 datasets imputed at Baseline.||3.508|-0.327|0.104
72368123|NCT05462756|144246136|SUPERIORITY||LS Mean Difference|-1.5||||0.304|TWO_SIDED|95.0|-4.358|1.36|||ANCOVA|||LS Mean was determined by ANCOVA model using Baseline + Country + Personal Use of CGM or FGM at Randomization + Hemoglobin A1c Stratum at Baseline + Treatment (Type III sum of squares). Missing data at Baseline were imputed with multiple imputation with assumption of missing at random. Missing data at Week 22-Week 26 were imputed by return-to-baseline multiple imputations approach. A total of 100 datasets were imputed with one for each of the 100 datasets imputed at Baseline.||1.360|-4.358|0.304
72368124|NCT05462756|144246137|SUPERIORITY||LS Mean Difference|0.23||||0.523|TWO_SIDED|95.0|-0.48|0.95|||Mixed Models Analysis|||LS Mean was determined by MMRM model with BASELINE + Hemoglobin A1c Stratum at Baseline + Country + Personal Use CGM or FGM at Randomization + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables. Unstructured variance-covariance structure was used.||0.95|-0.48|0.523
72368125|NCT05462756|144246138|SUPERIORITY||LS Mean Difference|-35.04|||<|0.001|TWO_SIDED|95.0|-55.57|-14.5|||Mixed Models Analysis|||LS Mean was determined by Mixed Model Repeated Measures (MMRM) model using BASELINE + Hemoglobin A1c Stratum at Baseline + Country + Personal Use CGM or FGM at Randomization + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables. Variance-covariance structure was set as compound symmetry.||-14.50|-55.57|<0.001
72368126|NCT05462756|144246139|SUPERIORITY||LS Mean Difference|-7.55|||<|0.001|TWO_SIDED|95.0|-10.79|-4.3|||Mixed Models Analysis|||LS Mean was determined by MMRM model using BASELINE + Hemoglobin A1c Stratum at Baseline + Country + Personal Use CGM or FGM at Randomization + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables. Variance-covariance structure was set as compound symmetry.||-4.30|-10.79|<0.001
72368127|NCT05462756|144246140|SUPERIORITY||LS Mean Difference|-73.5|||<|0.001|TWO_SIDED|95.0|-107.81|-39.2|||Mixed Models Analysis|||LS Mean was determined by MMRM model using BASELINE + Hemoglobin A1c Stratum at Baseline + Country + Personal Use CGM or FGM at Randomization + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables. Variance-covariance structure was set as compound symmetry.||-39.20|-107.81|<0.001
72368128|NCT05462756|144246141|SUPERIORITY||LS Mean Difference|3.53|||<|0.001|TWO_SIDED|95.0|1.49|5.58|||Mixed Models Analysis|||LS Mean was determined by MMRM model using BASELINE + Hemoglobin A1c Stratum at Baseline + Country + Personal Use CGM or FGM at Randomization + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables. Variance-covariance structure was set as compound symmetry.||5.58|1.49|<0.001
72368129|NCT05462756|144246142|SUPERIORITY||Mean Difference (Net)|1.11||||0.442|TWO_SIDED|95.0|0.85|1.44|||Negative binomial model|||Group mean was reported and determined by Negative binomial method using Baseline hypoglycemia rate + Hemoglobin A1c at Baseline (%) + Treatment, with log (exposure in days/365.25) as variables.||1.44|0.85|0.442
72368130|NCT05462756|144246143|SUPERIORITY||LS Mean Difference|0.14||||0.543|TWO_SIDED|95.0|-0.32|0.6|||Mixed Models Analysis|||LS Mean was determined by MMRM model using BASELINE + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables.||0.60|-0.32|0.543
72368131|NCT05462756|144246144|SUPERIORITY||LS Mean Difference|1.8||||0.099|TWO_SIDED|95.0|-0.3|4.0|||ANCOVA|||LS Mean was determined by ANCOVA model using Country + Personal Use CGM or FGM at Randomization + Hemoglobin A1c Stratum at Baseline + Treatment (Type III sum of squares) as variables.||4.0|-0.3|0.099
72368132|NCT00990704|144246147|SUPERIORITY_OR_OTHER||Difference between arms in percentage|13.6||||0.518|TWO_SIDED|95.0|-22.36|49.63|||Fisher Exact|||||49.63|-22.36|0.518
72368133|NCT04040933|144246155|OTHER|Change from Baseline in TEWL measurements was analyzed within-treatment and between-treatment. The within-treatment comparison was performed at each baseline score within each treatment using paired t-test. The between-treatment comparison was performed by comparing the change from baseline between treatments using a mixed effect analysis of covariance (ANCOVA) model.||||||0.86|TWO_SIDED||||||ANCOVA|||||||0.860
72368134|NCT04040933|144246155|OTHER|Change from Baseline in TEWL measurements was analyzed within-treatment and between-treatment. The within-treatment comparison was performed at each baseline score within each treatment using paired t-test. The between-treatment comparison was performed by comparing the change from baseline between treatments using a mixed effect analysis of covariance (ANCOVA) model.||||||0.051|||||||ANCOVA|||||||0.051
72368135|NCT04040933|144246156|OTHER|Change from Baseline in Erythema measurements was analyzed within-treatment and between-treatment. The within-treatment comparison was performed at each post-baseline time point by comparing the post-baseline scores with the baseline score within each treatment using the paired t-test. The between-treatment comparison was performed by comparing the change from baseline between treatments using a mixed effect analysis of covariance (ANCOVA) model.||||||0.259|TWO_SIDED||||||ANCOVA|||||||0.259
72368136|NCT04040933|144246156|OTHER|Change from Baseline in Erythema measurements was analyzed within-treatment and between-treatment. The within-treatment comparison was performed at each post-baseline time point by comparing the post-baseline scores with the baseline score within each treatment using the paired t-test. The between-treatment comparison was performed by comparing the change from baseline between treatments using a mixed effect analysis of covariance (ANCOVA) model.||||||0.451|||||||ANCOVA|||||||0.451
72368137|NCT04040933|144246157|OTHER|Change from Baseline in Edema measurements was analyzed within-treatment and between-treatment. The within-treatment comparison was performed at each post-baseline time point by comparing the post-baseline scores with the baseline score within each treatment using the paired t-test. The between-treatment comparison was performed by comparing the change from baseline between treatments using a mixed effect analysis of covariance (ANCOVA) model.|||||>|0.999|TWO_SIDED||||||ANCOVA|||||||>0.999
72368138|NCT04040933|144246157|OTHER|Change from Baseline in Edema measurements was analyzed within-treatment and between-treatment. The within-treatment comparison was performed at each post-baseline time point by comparing the post-baseline scores with the baseline score within each treatment using the paired t-test. The between-treatment comparison was performed by comparing the change from baseline between treatments using a mixed effect analysis of covariance (ANCOVA) model.||||||0.739|||||||ANCOVA|||||||0.739
72368139|NCT04040933|144246158|OTHER|Change from Baseline in Composite Scar Score Measurements was analyzed within-treatment and between-treatment. The within-treatment comparison was performed at each post-baseline time point by comparing the post-baseline scores with the baseline score within each treatment using the paired t-test. The between-treatment comparison was performed by comparing the change from baseline between treatments using a mixed effect analysis of covariance (ANCOVA) model.|||||<|0.001|TWO_SIDED||||||ANCOVA|||||||<0.001
72368140|NCT04040933|144246158|OTHER|Change from Baseline in Composite Scar Score Measurements was analyzed within-treatment and between-treatment. The within-treatment comparison was performed at each post-baseline time point by comparing the post-baseline scores with the baseline score within each treatment using the paired t-test. The between-treatment comparison was performed by comparing the change from baseline between treatments using a mixed effect analysis of covariance (ANCOVA) model.||||||0.053|||||||ANCOVA|||||||0.053
72368141|NCT04040933|144246159|OTHER|Change in Baseline in Painful Score with Arm Resting by Side was analyzed within-treatment and between-treatment. The within-treatment comparison was performed at each post-baseline time point by comparing the post-baseline scores with the baseline score within each treatment using the paired t-test. The between-treatment comparison was performed by comparing the change from baseline between treatments using a mixed effect analysis of covariance (ANCOVA) model.||||||0.666|TWO_SIDED||||||ANCOVA|||||||0.666
72368142|NCT04040933|144246159|OTHER|Change in Baseline in Painful Score with Arm Resting by Side was analyzed within-treatment and between-treatment. The within-treatment comparison was performed at each post-baseline time point by comparing the post-baseline scores with the baseline score within each treatment using the paired t-test. The between-treatment comparison was performed by comparing the change from baseline between treatments using a mixed effect analysis of covariance (ANCOVA) model.||||||0.473|||||||ANCOVA|||||||0.473
72368143|NCT04040933|144246160|OTHER|Change from Baseline In Painful Score with Arm in Normal Motion was analyzed within-treatment and between-treatment. The within-treatment comparison was performed at each post-baseline time point by comparing the post-baseline scores with the baseline score within each treatment using the paired t-test. The between-treatment comparison was performed by comparing the change from baseline between treatments using a mixed effect analysis of covariance (ANCOVA) model.||||||0.761|TWO_SIDED||||||ANCOVA|||||||0.761
72368144|NCT04040933|144246160|OTHER|Change from Baseline In Painful Score with Arm in Normal Motion was analyzed within-treatment and between-treatment. The within-treatment comparison was performed at each post-baseline time point by comparing the post-baseline scores with the baseline score within each treatment using the paired t-test. The between-treatment comparison was performed by comparing the change from baseline between treatments using a mixed effect analysis of covariance (ANCOVA) model.||||||0.456|||||||ANCOVA|||||||0.456
72368145|NCT04040933|144246161|OTHER|Change from Baseline In Itchy Score was analyzed within-treatment and between-treatment. The within-treatment comparison was performed at each post-baseline time point by comparing the post-baseline scores with the baseline score within each treatment using the paired t-test. The between-treatment comparison was performed by comparing the change from baseline between treatments using a mixed effect analysis of covariance (ANCOVA) model.||||||0.019|TWO_SIDED||||||ANCOVA|||||||0.019
72368146|NCT04040933|144246161|OTHER|Change from Baseline In Itchy Score was analyzed within-treatment and between-treatment. The within-treatment comparison was performed at each post-baseline time point by comparing the post-baseline scores with the baseline score within each treatment using the paired t-test. The between-treatment comparison was performed by comparing the change from baseline between treatments using a mixed effect analysis of covariance (ANCOVA) model.||||||0.325|||||||ANCOVA|||||||0.325
72368147|NCT04040933|144246162|OTHER|Time to complete healing was analyzed using a survival analysis method. The survival function (cumulative percentage of wounds healed at each time point) was estimated by the Kaplan-Meier method for each treatment separately. The median time to complete healing was derived from the estimated survival functions and be compared using the bootstrap re-sampling method.|||||<|0.001|TWO_SIDED|||||no adjustments|Boot-strap sampling method|||All hypothesis tests was conducted at 0.05 level without adjustment of multiple comparisons||||<0.001
72368148|NCT04040933|144246162|OTHER|Time to complete healing was analyzed using a survival analysis method. The survival function (cumulative percentage of wounds healed at each time point) was estimated by the Kaplan-Meier method for each treatment separately. The median time to complete healing was derived from the estimated survival functions and be compared using the bootstrap re-sampling method.|||||<|0.001||||||no adjustments|Boot-strap sampling method|||||||<0.001
72368149|NCT00220636|144246213|SUPERIORITY_OR_OTHER||t statistic|4.7|||<|0.001|TWO_SIDED|95.0|||||t-test, 2 sided|df=13||Null hypothesis would be no change in the HDRS score pre- to post- treatment with aripiprazole.||||<.001
72368150|NCT00220636|144246215|SUPERIORITY_OR_OTHER||t statistic|-3.1||||0.009|TWO_SIDED|95.0|||||t-test, 2 sided|df=13||Null hypothesis would be no change in the GAFS score pre- to post- treatment with aripiprazole.||||.009
72368151|NCT00220636|144246216|SUPERIORITY_OR_OTHER||t statistic|3.1||||0.008|TWO_SIDED|95.0|||||t-test, 2 sided|df=13||Null hypothesis would be no change in the BDI score pre- to post- treatment with aripiprazole.||||.008
72368152|NCT01995838|144246248|SUPERIORITY||LS Mean Difference|0.51||||0.0651|TWO_SIDED|95.0|-0.03|1.06|||ANCOVA|Baseline value and treatment as covariates.||||1.06|-0.03|0.0651
72368153|NCT01995838|144246248|SUPERIORITY||LS Mean Difference|0.13||||0.649|TWO_SIDED|95.0|-0.44|0.7|||ANCOVA|Baseline value and treatment as covariates.||||0.70|-0.44|0.6490
72368154|NCT01995838|144246248|SUPERIORITY||LS Mean Difference|0.43||||0.1059|TWO_SIDED|95.0|-0.09|0.94|||ANCOVA|Baseline value and treatment as covariates.||||0.94|-0.09|0.1059
72368155|NCT01995838|144246248|SUPERIORITY||LS Mean Difference|0.01||||0.9818|TWO_SIDED|95.0||0.55|||ANCOVA|Baseline value and treatment as covariates.||||0.55|-0. 54|0. 9818
72368156|NCT01995838|144246248|SUPERIORITY||LS Mean Difference|0.38||||0.1071|TWO_SIDED|95.0|-0.08|0.85|||ANCOVA|Baseline value and treatment as covariates.||||0.85|-0.08|0. 1071
72368157|NCT01995838|144246248|SUPERIORITY||LS Mean Difference|0.68||||0.0063|TWO_SIDED|95.0|0.19|1.17|||ANCOVA|Baseline value and treatment as covariates.||||1.17|0.19|0.0063
72368158|NCT01995838|144246249|SUPERIORITY||LS Mean Difference|4.57||||0.0083|TWO_SIDED|95.0|1.19|7.94|||ANCOVA|Baseline value and treatment as covariates.||Days 1-2||7.94|1.19|0.0083
72368159|NCT01995838|144246249|SUPERIORITY||LS Mean Difference|4.44||||0.0151|TWO_SIDED|95.0|0.86|8.01|||ANCOVA|Baseline value and treatment as covariates.||Days 1-2||8.01|0.86|0.0151
72368160|NCT01995838|144246249|SUPERIORITY||LS Mean Difference|5.74||||0.0005|TWO_SIDED|95.0|2.54|8.93|||ANCOVA|Baseline value and treatment as covariates.||Days 1-2||8.93|2.54|0.0005
72368161|NCT01995838|144246249|SUPERIORITY||LS Mean Difference|8.09|||<|0.0001|TWO_SIDED|95.0|4.73|11.45|||ANCOVA|||Days 1-2||11.45|4.73|<0.0001
72368162|NCT01995838|144246249|SUPERIORITY||LS Mean Difference|10.06|||<|0.0001|TWO_SIDED|95.0|7.2|12.93|||ANCOVA|Baseline value and treatment as covariates.||Days 1-2||12.93|7.20|<0.0001
72368163|NCT01995838|144246249|SUPERIORITY||LS Mean Difference|10.13|||<|0.0001|TWO_SIDED|95.0|7.18|13.08|||ANCOVA|Baseline value and treatment as covariates.||Days 1-2||13.08|7.18|<0.0001
72368164|NCT01995838|144246249|SUPERIORITY||LS Mean Difference|0.34||||0.8505|TWO_SIDED|95.0|-3.22|3.9|||ANCOVA|Baseline value and treatment as covariates.||Days 14-15||3.90|-3.22|0.8505
72368165|NCT01995838|144246249|SUPERIORITY||LS Mean Difference|3.94||||0.038|TWO_SIDED|95.0|0.22|7.66|||ANCOVA|Baseline value and treatment as covariates.||Days 14-15||7.66|0.22|0.0380
72368166|NCT01995838|144246249|SUPERIORITY||LS Mean Difference|5.76||||0.0008|TWO_SIDED|95.0|2.4|9.12|||ANCOVA|Baseline value and treatment as covariates.||Days 14-15||9.12|2.40|0.0008
72368167|NCT01995838|144246249|SUPERIORITY||LS Mean Difference|7.78|||<|0.0001|TWO_SIDED|95.0|4.24|11.32|||ANCOVA|Baseline value and treatment as covariates.||Days 14-15||11.32|4.24|<0.0001
72368168|NCT01995838|144246249|SUPERIORITY||LS Mean Difference|7.89|||<|0.0001|TWO_SIDED|95.0|4.86|10.92|||ANCOVA|Baseline value and treatment as covariates.||Days 14-15||10.92|4.86|<0.0001
72368169|NCT01995838|144246249|SUPERIORITY||LS Mean Difference|8.87|||<|0.0001|TWO_SIDED|95.0|5.72|12.02|||ANCOVA|Baseline value and treatment as covariates.||Days 14-15||12.02|5.72|<0.0001
72368170|NCT01995838|144246250|SUPERIORITY||Geometric Mean Ratio|0.77||||0.1407|TWO_SIDED|95.0|0.54|1.09|||ANCOVA|Baseline value and treatment as covariates.||Days 1-2||1.09|0.54|0.1407
72368171|NCT01995838|144246250|SUPERIORITY|Days 1-2|Geometric Mean Ratio|0.55||||0.0018|TWO_SIDED|95.0|0.38|0.8|||ANCOVA|Baseline value and treatment as covariates.||||0.80|0.38|0.0018
72368172|NCT01995838|144246250|SUPERIORITY||Geometric Mean Ratio|0.6||||0.0025|TWO_SIDED|95.0|0.43|0.83|||ANCOVA|Baseline value and treatment as covariates.||Days 1-2||0.83|0.43|0.0025
72368173|NCT01995838|144246250|SUPERIORITY||Geometric Mean Ratio|0.54||||0.0006|TWO_SIDED|95.0|0.38|0.76|||ANCOVA|Baseline value and treatment as covariates.||Days 1-2||0.76|0.38|0.0006
72368174|NCT01995838|144246250|SUPERIORITY||Geometric Mean Ratio|0.52|||<|0.0001|TWO_SIDED|95.0|0.38|0.7|||ANCOVA|Baseline value and treatment as covariates.||Days 1-2||0.70|0.38|<0.0001
72368175|NCT01995838|144246250|SUPERIORITY||Geometric Mean Ratio|0.39|||<|0.0001|TWO_SIDED|95.0|0.29|0.54|||ANCOVA|Baseline value and treatment as covariates.||Days 1-2:||0.54|0.29|<0.0001
72368176|NCT01995838|144246250|SUPERIORITY||Geometric Mean Ratio|0.73||||0.1158|TWO_SIDED|95.0|0.49|1.08|||ANCOVA|Baseline value and treatment as covariates.||Days 14-15||1.08|0.49|0.1158
72368177|NCT01995838|144246250|SUPERIORITY||Geometric Mean Ratio|0.49||||0.001|TWO_SIDED|95.0|0.33|0.75|||ANCOVA|Baseline value and treatment as covariates.||Days 14-15||0.75|0.33|0.0010
72368178|NCT01995838|144246250|SUPERIORITY||Geometric Mean Ratio|0.47|||<|0.0001|TWO_SIDED|95.0|0.32|0.69|||ANCOVA|Baseline value and treatment as covariates.||Days 14-15||0.69|0.32|<0.0001
72368179|NCT01995838|144246250|SUPERIORITY||Geometric Mean Ratio|0.32|||<|0.0001|TWO_SIDED|95.0|0.21|0.47|||ANCOVA|Baseline value and treatment as covariates.||Days 14-15||0.47|0.21|<0.0001
72368180|NCT01995838|144246250|SUPERIORITY||Geometric Mean Ratio|0.41|||<|0.0001|TWO_SIDED|95.0|0.29|0.57|||ANCOVA|Baseline value and treatment as covariates.||Days 14-15||0.57|0.29|<0.0001
72368181|NCT01995838|144246250|SUPERIORITY||Geometric Mean Ratio|0.34|||<|0.0001|TWO_SIDED|95.0|0.24|0.48|||ANCOVA|Baseline value and treatment as covariates.||Days 14-15||0.48|0.24|<0.0001
72368182|NCT01995838|144246251|SUPERIORITY||LS Mean Difference|-11.08||||0.105|TWO_SIDED|95.0|-24.48|2.33|||ANCOVA|Baseline value and treatment as covariates.||Days 1-2||2.33|-24.48|0.1050
72368183|NCT01995838|144246251|SUPERIORITY||LS Mean Difference|-2.29||||0.7501|TWO_SIDED|95.0|-16.46|11.87|||ANCOVA|Baseline value and treatment as covariates.||Days 1-2||11.87|-16.46|0.7501
72368184|NCT01995838|144246251|SUPERIORITY||LS Mean Difference|-11.26||||0.0818|TWO_SIDED|95.0|-23.94|1.43|||ANCOVA|Baseline value and treatment as covariates.||Days 1-2||1.43|-23.94|0.0818
72368185|NCT01995838|144246251|SUPERIORITY||LS Mean Difference|-19.81||||0.0038|TWO_SIDED|95.0|-33.18|-6.43|||ANCOVA|Baseline value and treatment as covariates.||Days 1-2||-6.43|-33.18|0.0038
72368186|NCT01995838|144246251|SUPERIORITY||LS Mean Difference|-29.34|||<|0.0001|TWO_SIDED|95.0|-40.75|17.93|||ANCOVA|Baseline value and treatment as covariates.||Days 1-2||17.93|-40.75|<0.0001
72368187|NCT01995838|144246251|SUPERIORITY||LS Mean Difference|-25.84|||<|0.0001|TWO_SIDED|95.0|-37.59|-14.09|||ANCOVA|Baseline value and treatment as covariates.||Days 1-2||-14.09|-37.59|<0.0001
72368188|NCT01995838|144246251|SUPERIORITY||LS Mean Difference|0.4642||||0.4642|TWO_SIDED|95.0|-9.6|20.98|||ANCOVA|Baseline value and treatment as covariates.||Days 14-15||20.98|-9.60|0.4642
72368189|NCT01995838|144246251|SUPERIORITY|Baseline value and treatment as covariates.|LS Mean Difference|-2.31||||0.7754|TWO_SIDED|95.0|-18.27|13.64|||ANCOVA|Baseline value and treatment as covariates.||Days 14-15||13.64|-18.27|0.7754
72368190|NCT01995838|144246251|SUPERIORITY||LS Mean Difference|-10.69||||0.1461|TWO_SIDED|95.0|-25.14|3.75|||ANCOVA|Baseline value and treatment as covariates.||Days 14-15||3.75|-25.14|0.1461
72368191|NCT01995838|144246251|SUPERIORITY||LS Mean Difference|-14.73||||0.0581|TWO_SIDED|95.0|-29.97|0.51|||ANCOVA|Baseline value and treatment as covariates.||Days 14-15||0.51|-29.97|0.0581
72368192|NCT01995838|144246251|SUPERIORITY||LS Mean Difference|-20.8||||0.0019|TWO_SIDED|95.0|-33.86|-7.74|||ANCOVA|Baseline value and treatment as covariates.||Days 14-15||-7.74|-33.86|0.0019
72368193|NCT01995838|144246251|SUPERIORITY||LS Mean Difference|-21.52||||0.002|TWO_SIDED|95.0|-35.12|-7.91|||ANCOVA|Baseline value and treatment as covariates.||Days 14-15||-7.91|-35.12|0.0020
72368194|NCT01995838|144246255|SUPERIORITY||LS Mean Difference|-3.05||||0.1483|TWO_SIDED|95.0|-7.2|1.09|||ANCOVA|Baseline value and treatment as covariates.||Days 16-17||1.09|-7.20|0.1483
72368195|NCT01995838|144246255|SUPERIORITY||LS Mean Difference|-0.64||||0.772|TWO_SIDED|95.0|-4.96|3.69|||ANCOVA|Baseline value and treatment as covariates.||Days 16-17||3.69|-4.96|0.7720
72368196|NCT01995838|144246255|SUPERIORITY||LS Mean Difference|1.5||||0.4548|TWO_SIDED|95.0|-2.44|5.44|||ANCOVA|Baseline value and treatment as covariates.||Days 16-17||5.44|-2.44|0.4548
72368197|NCT01995838|144246255|SUPERIORITY||LS Mean Difference|-2.39||||0.253|TWO_SIDED|95.0|-6.51|1.72|||ANCOVA|Baseline value and treatment as covariates.||Days 16-17||1.72|-6.51|0.2530
72368198|NCT01995838|144246255|SUPERIORITY||LS Mean Difference|2.41||||0.1794|TWO_SIDED|95.0|-1.11|5.93|||ANCOVA|Baseline value and treatment as covariates.||Days 16-17||5.93|-1.11|0.1794
72368199|NCT01995838|144246255|SUPERIORITY||LS Mean Difference|0.94||||0.6148|TWO_SIDED|95.0|-2.74|4.63|||ANCOVA|Baseline value and treatment as covariates.||Days 16-17||4.63|-2.74|0.6148
72368200|NCT02157883|144246266|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Upper bound of the 90% CIs below 200%.|Geometric mean ratio|79.87|||||TWO_SIDED|90.0|73.15|87.21|||||AZD9291+itraconazole / AZD9291 alone. Results based on linear mixed-effects model with treatment as fixed effect and patient as a random effect.|Study sized so experiment-wise power for the upper bound of the 90% CIs of geometric mean ratios for both AUC and Cmax of AZD9291 being below 200% was 90% (95% for each parameter). Within patient CV assumed to be 34%. A 50% increase in exposure was also assumed.||87.21|73.15|
72368201|NCT02157883|144246267|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Upper bound of the 90% CIs below 200%.|Geometric mean ratio|124.17|||||TWO_SIDED|90.0|114.61|134.53|||||AZD9291+itraconazole / AZD9291 alone. Results based on linear mixed-effects model with treatment as fixed effect and patient as a random effect.|Study sized so experiment-wise power for the upper bound of the 90% CIs of geometric mean ratios for both AUC and Cmax of AZD9291 being below 200% was 90% (95% for each parameter). Within patient CV assumed to be 34%. A 50% increase in exposure was also assumed.||134.53|114.61|
72368202|NCT02157883|144246274|SUPERIORITY_OR_OTHER_LEGACY||Geometric mean ratio|75.87|||||TWO_SIDED|90.0|64.18|89.69|||||AZD9291+itraconazole / AZD9291 alone. No pre-specified margins for equivalence test for metabolites, but analysed for consistency with AZD9291 analysis.|Study sized so experiment-wise power for the upper bound of the 90% CIs of geometric mean ratios for both AUC and Cmax of AZD9291 being below 200% was 90% (95% for each parameter). Within patient CV assumed to be 34%. A 50% increase in exposure was also assumed.||89.69|64.18|
72368203|NCT02157883|144246275|SUPERIORITY_OR_OTHER_LEGACY||Geometric mean ratio|108.25|||||TWO_SIDED|90.0|94.36|124.19|||||AZD9291+itraconazole / AZD9291 alone. No pre-specified margins for equivalence test for metabolites, but analysed for consistency with AZD9291 analysis.|Study sized so experiment-wise power for the upper bound of the 90% CIs of geometric mean ratios for both AUC and Cmax of AZD9291 being below 200% was 90% (95% for each parameter). Within patient CV assumed to be 34%. A 50% increase in exposure was also assumed.||124.19|94.36|
72368204|NCT02157883|144246276|SUPERIORITY_OR_OTHER_LEGACY||Geometric mean ratio|44.33|||||TWO_SIDED|90.0|39.94|49.21|||||AZD9291+itraconazole / AZD9291 alone. No pre-specified margins for equivalence test for metabolites, but analysed for consistency with AZD9291 analysis.|Study sized so experiment-wise power for the upper bound of the 90% CIs of geometric mean ratios for both AUC and Cmax of AZD9291 being below 200% was 90% (95% for each parameter). Within patient CV assumed to be 34%. A 50% increase in exposure was also assumed.||49.21|39.94|
72368205|NCT02157883|144246277|SUPERIORITY_OR_OTHER_LEGACY||Geometric mean ratio|49.02|||||TWO_SIDED|90.0|43.7|54.99|||||AZD9291+itraconazole / AZD9291 alone. No pre-specified margins for equivalence test for metabolites, but analysed for consistency with AZD9291 analysis.|Study sized so experiment-wise power for the upper bound of the 90% CIs of geometric mean ratios for both AUC and Cmax of AZD9291 being below 200% was 90% (95% for each parameter). Within patient CV assumed to be 34%. A 50% increase in exposure was also assumed.||54.99|43.70|
72368206|NCT00888940|144246278|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.001
72368207|NCT02141204|144246293|NON_INFERIORITY|Lower limit (LL) of the two-sided 95% confidence interval (CI) for the ratio of anti-RV IgA antibody GMCs between HRV Liq Group over the HRV Lyo Group should be greater than or equal to (≥) 0.5.|GMC ratio|0.93|||||TWO_SIDED|95.0|0.65|1.34|||ANCOVA|95% CI for the adjusted GMC ratio and the logarithm of baseline concentration were used as fixed effects in this ANCOVA model.||Anti-RV IgA GMCs (non-inferiority): Non-inferiority comparison between GSK Biologicals' HRV liquid vaccine (HRV Liq Group) and GSK Biologicals' HRV lyophilized vaccine (HRV Lyo Group) in terms of geometric mean concentrations (GMCs) for anti-RV antibodies, one month after the administration of the second dose of study vaccine.||1.34|0.65|
72368208|NCT01958164|144246312|SUPERIORITY_OR_OTHER||Mean Difference (Net)|73.3|||||TWO_SIDED|95.0|23.3|89.3|||||Difference calculated as actilyse minus saline solution|||89.3|23.3|
72368209|NCT01958164|144246313|SUPERIORITY_OR_OTHER||Mean Difference (Net)|66.7|||||TWO_SIDED|95.0|20.7|90.3|||||Difference calculated as actilyse minus saline solution|||90.3|20.7|
72368210|NCT02963506|144246317|OTHER||Correlation statistic|17.9|||<|0.001|||||||Cochran-Mantel-Haenszel|||Statistic and p-value were calculated using a Cochran-Mantel-Haenszel test (test for non-zero correlation statistic) based on modified ridit scores and including geographic region and prior Tumor Necrosis Factor (TNF) inhibitor exposure as stratification factors.||||<0.001
72368211|NCT02963506|144246317|OTHER|The pairwise testing of each bimekizumab dose versus placebo accounted for multiplicity by using a fixed sequence testing procedure with each bimekizumab dose being tested sequentially from the highest dose to the lowest dose. If the sequential testing failed to reach significance at a significance level of alpha=0.05, then the pairwise testing continued and the comparison was seen as non-significant.|Odds Ratio (OR)|2.6|||=|0.04|TWO_SIDED|95.0|1.04|6.48||The p-values were displayed as nominal p-values.|Regression, Logistic|||For differences in relation to placebo: Odds Ratio, confidence interval and p-value were derived from a logistic regression model including fixed effects for treatment, geographic region and prior tumor necrosis factor (TNF) inhibitor exposure.||6.48|1.04|=0.040
72368212|NCT02963506|144246317|OTHER|The pairwise testing of each bimekizumab dose versus placebo accounted for multiplicity by using a fixed sequence testing procedure with each bimekizumab dose being tested sequentially from the highest dose to the lowest dose. If the sequential testing failed to reach significance at a significance level of alpha=0.05, then the pairwise testing continued and the comparison was seen as non-significant.|Odds Ratio (OR)|4.5|||=|0.001|TWO_SIDED|95.0|1.83|10.86||The p-values were displayed as nominal p-values.|Regression, Logistic|||For differences in relation to placebo: Odds Ratio, confidence interval and p-value were derived from a logistic regression model including fixed effects for treatment, geographic region and prior TNF inhibitor exposure.||10.86|1.83|=0.001
72368213|NCT02963506|144246317|OTHER|The pairwise testing of each bimekizumab dose versus placebo accounted for multiplicity by using a fixed sequence testing procedure with each bimekizumab dose being tested sequentially from the highest dose to the lowest dose. If the sequential testing failed to reach significance at a significance level of alpha=0.05, then the pairwise testing continued and the comparison was seen as non-significant.|Odds Ratio (OR)|5.5|||<|0.001|TWO_SIDED|95.0|2.27|13.48||The p-values were displayed as nominal p-values.|Regression, Logistic|||For differences in relation to placebo: Odds Ratio, confidence interval and p-value were derived from a logistic regression model including fixed effects for treatment, geographic region and prior TNF inhibitor exposure.||13.48|2.27|<0.001
72368214|NCT02963506|144246317|OTHER|The pairwise testing of each bimekizumab dose versus placebo accounted for multiplicity by using a fixed sequence testing procedure with each bimekizumab dose being tested sequentially from the highest dose to the lowest dose. If the sequential testing failed to reach significance at a significance level of alpha=0.05, then the pairwise testing continued and the comparison was seen as non-significant.|Odds Ratio (OR)|5.3|||<|0.001|TWO_SIDED|95.0|2.19|12.92||The p-values were displayed as nominal p-values.|Regression, Logistic|||For differences in relation to placebo: Odds Ratio, confidence interval and p-value were derived from a logistic regression model including fixed effects for treatment, geographic region and prior TNF inhibitor exposure.||12.92|2.19|<0.001
72368215|NCT02963506|144246318|OTHER||LS Mean Difference vs placebo|-0.5|STANDARD_ERROR_OF_MEAN|0.16|<|0.001|TWO_SIDED|95.0|-0.86|-0.24|||ANCOVA|||Least squares (LS) Mean, standard error, confidence interval and p-value were derived using the analysis of covariance (ANCOVA) model with treatment, geographic region and prior TNF inhibitor exposure as fixed effects and the Baseline value as covariate.||-0.24|-0.86|<0.001
72368216|NCT02963506|144246318|OTHER||LS Mean Difference vs placebo|-1.2|STANDARD_ERROR_OF_MEAN|0.16|<|0.001|TWO_SIDED|95.0|-1.47|-0.83|||ANCOVA|||LS Mean, standard error, confidence interval and p-value were derived using the ANCOVA model with treatment, geographic region and prior TNF inhibitor exposure as fixed effects and the Baseline value as covariate.||-0.83|-1.47|<0.001
72368217|NCT02963506|144246318|OTHER||LS Mean Difference vs placebo|-1.0|STANDARD_ERROR_OF_MEAN|0.16|<|0.001|TWO_SIDED|95.0|-1.35|-0.72|||ANCOVA|||LS Mean, standard error, confidence interval and p-value were derived using the ANCOVA model with treatment, geographic region and prior TNF inhibitor exposure as fixed effects and the Baseline value as covariate.||-0.72|-1.35|<0.001
72368218|NCT02963506|144246318|OTHER||LS Mean Difference vs placebo|-1.1|STANDARD_ERROR_OF_MEAN|0.16|<|0.001|TWO_SIDED|95.0|-1.45|-0.82|||ANCOVA|||LS Mean, standard error, confidence interval and p-value were derived using the ANCOVA model with treatment, geographic region and prior TNF inhibitor exposure as fixed effects and the Baseline value as covariate.||-0.82|-1.45|<0.001
72368219|NCT02963506|144246319|OTHER||Odds Ratio (OR)|1.7|||=|0.163|TWO_SIDED|95.0|0.8|3.67||The p-values were displayed as nominal p-values.|Regression, Logistic|||For differences in relation to placebo: Odds Ratio, confidence interval and p-value were derived from a logistic regression model including fixed effects for treatment, geographic region and prior TNF inhibitor exposure.||3.67|0.80|=0.163
72553304|NCT00834067|144638037|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|104.0||||||90.0|99.9|108.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||108|99.9|
72553305|NCT00834067|144638038|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|103.0||||||90.0|99.7|107.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||107|99.7|
72553306|NCT00834067|144638039|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|101.0||||||90.0|96.0|106.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||106|96|
72553307|NCT00834067|144638040|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|101.0||||||90.0|99.1|102.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||102|99.1|
72553308|NCT00834067|144638041|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|101.0||||||90.0|99.4|103.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||103|99.4|
72553309|NCT00834067|144638042|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|107.0||||||90.0|99.8|114.0|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||114|99.8|
72553310|NCT00834067|144638043|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|102.0||||||90.0|99.0|106.0|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||106|99|
72553311|NCT00834067|144638044|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|103.0||||||90.0|98.1|108.0|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||108|98.1|
72553312|NCT01705574|144638069|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The null hypothesis was that the STB group was at least 12% worse than the ATV+RTV+TVD group with respect to the percentage of participants achieving HIV-1 RNA \< 50 copies/mL at Week 48 (response rate as defined by the snapshot analysis algorithm). The alternative hypothesis was that the STB group was less than 12% worse than the ATV+RTV+TVD group.|Difference in proportions|6.5|||||TWO_SIDED|95.2|0.4|12.6|||||Difference in percentages of virologic success and its 95.2% confidence interval (CI) were calculated based on baseline HIV-1 RNA and race stratum-adjusted Mantel-Haenszel (MH) proportion.|||12.6|0.4|
72553313|NCT01705574|144638069|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportions|6.5||||0.034|TWO_SIDED|95.2|0.4|12.6|||Cochran-Mantel-Haenszel|P-value comparing virologic success was from the CMH test stratified by baseline HIV-1 RNA and race strata.|Difference in percentages of virologic success and its 95.2% CI were calculated based on baseline HIV-1 RNA and race stratum-adjusted MH proportion. If the lower bound of the CI was \> 0, superiority of STB over ATV+RTV+TVD was established.|If noninferiority of STB versus ATV+RTV+TVD was established, the same 95.2% CI used in evaluating noninferiority was used to evaluate superiority. The baseline HIV-1 RNA and race stratum-stratified, 2-sided CMH test was also used to assess superiority as a secondary assessment.||12.6|0.4|0.034
72553314|NCT00089661|144638081|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.5|||<|0.0001||95.0|4.8|6.3|||ANCOVA|||||6.3|4.8|<0.0001
72553315|NCT02647944|144638095|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
72553316|NCT02647944|144638096|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
72553317|NCT02647944|144638097|SUPERIORITY|||||||0.27|||||||Wilcoxon (Mann-Whitney)|||||||0.27
72553318|NCT02647944|144638098|SUPERIORITY|||||||0.069|||||||Wilcoxon (Mann-Whitney)|||||||0.069
72553319|NCT02647944|144638099|SUPERIORITY|||||||0.054|||||||Wilcoxon (Mann-Whitney)|||||||0.054
72553320|NCT02647944|144638100|SUPERIORITY|||||||0.13|||||||Wilcoxon (Mann-Whitney)|||||||0.13
72553321|NCT02647944|144638101|SUPERIORITY|||||||0.68|||||||Wilcoxon (Mann-Whitney)|||||||0.68
72553322|NCT02647944|144638102|SUPERIORITY|||||||0.95|||||||Wilcoxon (Mann-Whitney)|||||||0.95
72368220|NCT02963506|144246319|OTHER||Odds Ratio (OR)|3.9|||<|0.001|TWO_SIDED|95.0|1.84|8.48||The p-values were displayed as nominal p-values.|Regression, Logistic|||For differences in relation to placebo: Odds Ratio, confidence interval and p-value were derived from a logistic regression model including fixed effects for treatment, geographic region and prior TNF inhibitor exposure.||8.48|1.84|<0.001
72368221|NCT02963506|144246319|OTHER||Odds Ratio (OR)|3.5|||=|0.001|TWO_SIDED|95.0|1.66|7.61||The p-values were displayed as nominal p-values.|Regression, Logistic|||For differences in relation to placebo: Odds Ratio, confidence interval and p-value were derived from a logistic regression model including fixed effects for treatment, geographic region and prior TNF inhibitor exposure.||7.61|1.66|=0.001
72368222|NCT02963506|144246319|OTHER||Odds Ratio (OR)|6.5|||<|0.001|TWO_SIDED|95.0|2.92|14.28||The p-values were displayed as nominal p-values.|Regression, Logistic|||For differences in relation to placebo: Odds Ratio, confidence interval and p-value were derived from a logistic regression model including fixed effects for treatment, geographic region and prior TNF inhibitor exposure.||14.28|2.92|<0.001
72368223|NCT02963506|144246320|OTHER||Odds Ratio (OR)|5.3|||=|0.003|TWO_SIDED|95.0|1.74|15.96||The p-values were displayed as nominal p-values.|Regression, Logistic|||For differences in relation to placebo: Odds Ratio, confidence interval and p-value were derived from a logistic regression model including fixed effects for treatment, geographic region and prior TNF inhibitor exposure.||15.96|1.74|=0.003
72368224|NCT02963506|144246320|OTHER||Odds Ratio (OR)|11.9|||<|0.001|TWO_SIDED|95.0|4.03|35.38||The p-values were displayed as nominal p-values.|Regression, Logistic|||For differences in relation to placebo: Odds Ratio, confidence interval and p-value were derived from a logistic regression model including fixed effects for treatment, geographic region and prior TNF inhibitor exposure.||35.38|4.03|<0.001
72368225|NCT02963506|144246320|OTHER||Odds Ratio (OR)|14.3|||<|0.001|TWO_SIDED|95.0|4.81|42.46||The p-values were displayed as nominal p-values.|Regression, Logistic|||For differences in relation to placebo: Odds Ratio, confidence interval and p-value were derived from a logistic regression model including fixed effects for treatment, geographic region and prior TNF inhibitor exposure.||42.46|4.81|<0.001
72368226|NCT02963506|144246320|OTHER||Odds Ratio (OR)|14.9|||<|0.001|TWO_SIDED|95.0|5.02|44.27||The p-values were displayed as nominal p-values.|Regression, Logistic|||For differences in relation to placebo: Odds Ratio, confidence interval and p-value were derived from a logistic regression model including fixed effects for treatment, geographic region and prior TNF inhibitor exposure.||44.27|5.02|<0.001
72368227|NCT02963506|144246321|OTHER||LS Mean Difference vs placebo|-0.6|STANDARD_ERROR_OF_MEAN|0.36|=|0.094|TWO_SIDED|95.0|-1.31|0.1|||ANCOVA|||LS Mean, standard error, confidence interval and p-value were derived using the ANCOVA model with treatment, geographic region and prior TNF inhibitor exposure as fixed effects and the Baseline value as covariate.||0.10|-1.31|=0.094
72368228|NCT02963506|144246321|OTHER||LS Mean Difference vs placebo|-1.6|STANDARD_ERROR_OF_MEAN|0.37|<|0.001|TWO_SIDED|95.0|-2.34|-0.91|||ANCOVA|||LS Mean, standard error, confidence interval and p-value were derived using the ANCOVA model with treatment, geographic region and prior TNF inhibitor exposure as fixed effects and the Baseline value as covariate.||-0.91|-2.34|<0.001
72368229|NCT02963506|144246321|OTHER||LS Mean Difference vs placebo|-1.6|STANDARD_ERROR_OF_MEAN|0.37|<|0.001|TWO_SIDED|95.0|-2.35|-0.91|||ANCOVA|||LS Mean, standard error, confidence interval and p-value were derived using the ANCOVA model with treatment, geographic region and prior TNF inhibitor exposure as fixed effects and the Baseline value as covariate.||-0.91|-2.35|<0.001
72368230|NCT02963506|144246321|OTHER||LS Mean Difference vs placebo|-1.9|STANDARD_ERROR_OF_MEAN|0.36|<|0.001|TWO_SIDED|95.0|-2.6|-1.18|||ANCOVA|||LS Mean, standard error, confidence interval and p-value were derived using the ANCOVA model with treatment, geographic region and prior TNF inhibitor exposure as fixed effects and the Baseline value as covariate.||-1.18|-2.60|<0.001
72368231|NCT02963506|144246322|OTHER||LS Mean Difference vs placebo|-0.6|STANDARD_ERROR_OF_MEAN|0.36|=|0.075|TWO_SIDED|95.0|-1.35|0.07|||ANCOVA|||LS Mean, standard error, confidence interval and p-value were derived using the ANCOVA model with treatment, geographic region and prior TNF inhibitor exposure as fixed effects and the Baseline value as covariate.||0.07|-1.35|=0.075
72368232|NCT02963506|144246322|OTHER||LS Mean Difference vs placebo|-1.1|STANDARD_ERROR_OF_MEAN|0.36|=|0.003|TWO_SIDED|95.0|-1.79|-0.37|||ANCOVA|||LS Mean, standard error, confidence interval and p-value were derived using the ANCOVA model with treatment, geographic region and prior TNF inhibitor exposure as fixed effects and the Baseline value as covariate.||-0.37|-1.79|=0.003
72368233|NCT02963506|144246322|OTHER||LS Mean Difference vs placebo|-1.1|STANDARD_ERROR_OF_MEAN|0.36|=|0.002|TWO_SIDED|95.0|-1.84|-0.42|||ANCOVA|||LS Mean, standard error, confidence interval and p-value were derived using the ANCOVA model with treatment, geographic region and prior TNF inhibitor exposure as fixed effects and the Baseline value as covariate.||-0.42|-1.84|=0.002
72553323|NCT02760368|144638124|SUPERIORITY||Risk Difference (RD)|0.378|||<|0.0001|TWO_SIDED|97.5|0.248|0.489|||Chi-squared|2x2 chi-square test||The OKZ ACR20 response rates for 64 q2w treatment group at Week 12 are expected to be at least 55%, resulting in an expected difference in ACR20 response rates of 30 percentage points between respective OKZ treatment group and placebo. Sample size yield 100% disjunctive power for testing the primary hypothesis.||0.489|0.248|<0.0001
72553324|NCT02760368|144638124|SUPERIORITY||Risk Difference (RD)|0.445|||<|0.0001|TWO_SIDED|97.5|0.318|0.552|||Chi-squared|2x2 chi-square test||The OKZ ACR20 response rates for 64 q4w treatment group at Week 12 are expected to be at least 50%, resulting in an expected difference in ACR20 response rates of 25 percentage points between respective OKZ treatment group and placebo. Sample size yield 100% disjunctive power for testing the primary hypothesis.||0.552|0.318|<0.0001
72553325|NCT02760368|144638125|SUPERIORITY||Risk Difference (RD)|0.294|||<|0.0001|TWO_SIDED|97.5|0.197|0.389|||Chi-squared|2x2 chi-square test||DAS28 low disease activity (based on DAS28 \[CRP\] \<3.2) response rate at Week 12 was estimated to be 10% in the placebo group and 30% in 64 q2w OKZ treatment groups respectively, resulting in an expected difference of 20 percentage points between OKZ q2w treatment group and placebo.||0.389|0.197|<0.0001
72553326|NCT02760368|144638125|SUPERIORITY||Risk Difference (RD)|0.352|||<|0.0001|TWO_SIDED|97.5|0.251|0.449|||Chi-squared|2x2 chi-square test||DAS28 low disease activity (based on DAS28 \[CRP\] \<3.2) response rate at Week 12 was estimated to be 10% in the placebo group and 22% in 64 mg q4w OKZ treatment group respectively, resulting in an expected difference of 12 percentage points between OKZ q4w treatment group and placebo.||0.449|0.251|<0.0001
72368234|NCT02963506|144246322|OTHER||LS Mean Difference vs placebo|-1.5|STANDARD_ERROR_OF_MEAN|0.36|<|0.001|TWO_SIDED|95.0|-2.22|-0.81|||ANCOVA|||LS Mean, standard error, confidence interval and p-value were derived using the ANCOVA model with treatment, geographic region and prior TNF inhibitor exposure as fixed effects and the Baseline value as covariate.||-0.81|-2.22|<0.001
72368235|NCT01397968|144246326|SUPERIORITY||||||<|0.0001|||||||Wilcoxon rank sum|||||||<0.0001
72368236|NCT01397968|144246327|SUPERIORITY||||||<|0.0001|||||||Regression, Logistic|||||||<0.0001
72368237|NCT02970162|144246337|SUPERIORITY|||||||0.0004||||||LS means|Least square means|Fixed effects treatment and QMG at Baseline. Between-treatment difference in LS means (95% CI) -6.54 (-9.78, -3.29).||||||0.0004
72368238|NCT02970162|144246338|SUPERIORITY||LS means|2.95||||0.0003|TWO_SIDED|95.0|1.53|4.38||CFB for SGI score was modeled as the response, with fixed effects terms for treatment and SGI at Baseline|Fixed effects linear model|This statistical test applies to the change from baseline SGI scores to Day 4 values row.||||4.38|1.53|0.0003
72368239|NCT02970162|144246339|SUPERIORITY|||||||0.002|||||||Wilcoxon Rank Sum Test|||||||0.0020
72368240|NCT02970162|144246340|SUPERIORITY|||||||0.0112|||||||Fisher Exact|||||||0.0112
72368241|NCT00750438|144246341|SUPERIORITY|||||||0.972|||||||Regression, Linear|||||||0.972
72368242|NCT00750438|144246342|SUPERIORITY|||||||0.559|||||||t-test, 2 sided|||Baseline and 24 weeks||||0.559
72368243|NCT00750438|144246342|SUPERIORITY|||||||0.062|||||||t-test, 2 sided|||Baseline to 24 weeks||||0.062
72368244|NCT00750438|144246342|SUPERIORITY|||||||0.099|||||||Regression, Linear|||||||0.099
72553327|NCT02760368|144638126|SUPERIORITY||Least Squares Mean Difference|-0.34|STANDARD_ERROR_OF_MEAN|0.059|<|0.0001|TWO_SIDED|97.5|-0.47|-0.21|||ANCOVA|||||-0.21|-0.47|<0.0001
72368245|NCT00750438|144246343|SUPERIORITY|||||||0.036|||||||Regression, Linear|||||||0.036
72553328|NCT02760368|144638126|SUPERIORITY||Least Squares Mean Difference|-0.36|STANDARD_ERROR_OF_MEAN|0.059|<|0.0001|TWO_SIDED|97.5|-0.49|-0.23|||ANCOVA|||||-0.23|-0.49|<0.0001
72553329|NCT02760368|144638127|SUPERIORITY||Risk Difference (RD)|0.35|||<|0.0001|TWO_SIDED|97.5|0.239|0.45|||Chi-squared|2x2 chi-square test||||0.450|0.239|<0.0001
72368246|NCT00750438|144246344|SUPERIORITY|||||||0.001|||||||t-test, 2 sided|||Baseline to 24 weeks||||0.001
72368247|NCT00750438|144246344|SUPERIORITY|||||||0.723|||||||t-test, 2 sided|||Baseline to 24 weeks||||0.723
72368248|NCT00750438|144246344|SUPERIORITY|||||||0.027|||||||Regression, Linear|||||||0.027
72368249|NCT00750438|144246345|SUPERIORITY|||||||0.372|||||||t-test, 2 sided|||||||0.372
72368250|NCT00750438|144246345|SUPERIORITY|||||||0.644|||||||t-test, 2 sided|||||||0.644
72368251|NCT00750438|144246345|SUPERIORITY|||||||0.549|||||||Regression, Linear|||||||0.549
72368252|NCT04845568|144246350|SUPERIORITY||Mean Difference (Net)|1.13|STANDARD_ERROR_OF_MEAN|2.08||0.592|TWO_SIDED|95.0|-3.16|5.43||A priori threshold for statistical significance was set at p\<0.05.|t-test, 2 sided|Degrees of freedom = 25||This analysis is for the outcome: Change in Self-Efficacy for Physical Activity. It is an independent samples t test. It is testing the null hypothesis that the mean change in self-efficacy for physical activity does not differ between conditions.||5.43|-3.16|0.592
72368253|NCT04845568|144246350|SUPERIORITY||Mean Difference (Net)|-1.19|STANDARD_ERROR_OF_MEAN|1.56||0.453|TWO_SIDED|95.0|-4.39|2.02||A priori threshold for statistical significance was set at p\<0.05.|t-test, 2 sided|Degrees of freedom = 25||This analysis is for the outcome: Change in Self-Efficacy for Healthy Eating. It is an independent samples t test. It is testing the null hypothesis that the mean change in self-efficacy for healthy eating does not differ between conditions.||2.02|-4.39|0.453
72368254|NCT04845568|144246351|SUPERIORITY||Mean Difference (Net)|0.275|STANDARD_ERROR_OF_MEAN|0.3||0.368|TWO_SIDED|95.0|-0.342|0.892||A priori threshold for statistical significance set at p\< 0.05.|t-test, 2 sided|Degrees of freedom = 25||This analysis is for the outcome: Change in Caregiver Readiness to Change Child's Eating. It is an independent samples t test. It is testing the null hypothesis that the mean change in readiness for healthy eating does not differ between conditions.||.892|-.342|.368
72368255|NCT04845568|144246351|SUPERIORITY||Mean Difference (Net)|0.126|STANDARD_ERROR_OF_MEAN|0.34||0.714|TWO_SIDED|95.0|-0.575|0.827||A priori threshold for statistical significance set at p\< .05.|t-test, 2 sided|Degrees of freedom = 25||This analysis is for the outcome: Change in Caregiver Readiness for Physical Activity. It is an independent samples t test. It is testing the null hypothesis that the mean change in caregiver intentions to help child improve physical activity from baseline to two-week follow up does not differ between conditions.||.827|-.575|.714
72368256|NCT04845568|144246352|SUPERIORITY||Mean Difference (Net)|-0.522|STANDARD_ERROR_OF_MEAN|1.88||0.783|TWO_SIDED|95.0|-4.39|3.34||A priori threshold for statistical significance set at p\<.05.|t-test, 2 sided|Degrees of freedom = 25||This analysis is for the outcome: Change in child attitudes toward healthy eating. It is an independent samples t test. It is testing the null hypothesis that the mean change in child attitudes toward healthy eating from baseline to post-intervention does not differ between conditions.||3.34|-4.39|.783
72368257|NCT04845568|144246352|SUPERIORITY||Mean Difference (Net)|-1.99|STANDARD_ERROR_OF_MEAN|1.97||0.323|TWO_SIDED|95.0|-6.05|2.07||A priori threshold for statistical significance set at p\<.05.|t-test, 2 sided|Degrees of freedom = 25||This analysis is for the outcome: Change in child intentions toward healthy eating. It is an independent samples t test. It is testing the null hypothesis that the mean change in child intentions toward healthy eating from baseline to post-intervention does not differ between conditions.||2.07|-6.05|.323
72368258|NCT04845568|144246352|SUPERIORITY||Mean Difference (Net)|2.11|STANDARD_ERROR_OF_MEAN|1.89||0.276|TWO_SIDED|95.0|-1.79|6.01||A priori threshold for statistical significance is set at p\<.05.|t-test, 2 sided|Degrees of freedom = 25||This analysis is for the outcome: Change in caregiver intentions toward helping their child engage in healthy eating. It is an independent samples t test. It is testing the null hypothesis that the mean change in caregiver intentions from baseline to post-intervention does not differ between conditions.||6.01|-1.79|.276
72368259|NCT04845568|144246353|SUPERIORITY||Mean Difference (Net)|0.247|STANDARD_ERROR_OF_MEAN|0.4||0.547|TWO_SIDED|95.0|-0.59|1.08||A priori threshold for statistical significance set at p\<.05.|t-test, 2 sided|Degrees of freedom = 25||This analysis is for the outcome: Change in child intake of fruits. It is an independent samples t test. It is testing the null hypothesis that the mean change in child fruit servings per week from baseline to two-week follow up does not differ between conditions.||1.08|-.59|.547
72553330|NCT02760368|144638127|SUPERIORITY||Risk Difference (RD)|0.409|||<|0.0001|TWO_SIDED|97.5|0.296|0.509|||Chi-squared|2x2 chi-square test||||0.509|0.296|<0.0001
72368260|NCT04845568|144246353|SUPERIORITY||Mean Difference (Net)|-0.005|STANDARD_ERROR_OF_MEAN|0.42||0.99|TWO_SIDED|95.0|-0.87|0.86||A priori threshold for statistical significance set at p\<.05.|t-test, 2 sided|Degrees of freedom = 25||This analysis is for the outcome: Change in child intake of vegetables. It is an independent samples t test. It is testing the null hypothesis that the mean change in child vegetable servings per week from baseline to two-week follow up does not differ between conditions.||.86|-.87|.990
72368261|NCT04845568|144246353|SUPERIORITY||Mean Difference (Net)|-0.203|STANDARD_ERROR_OF_MEAN|0.32||0.527|TWO_SIDED|95.0|-0.86|0.45||A priori threshold for statistical significance set at p\<.05.|t-test, 2 sided|Degrees of freedom = 25||This analysis is for the outcome: Change in child intake of fast food. It is an independent samples t test. It is testing the null hypothesis that the mean change in child fast food servings per week from baseline to two-week follow up does not differ between conditions.||.45|-.86|.527
72368262|NCT04845568|144246354|SUPERIORITY||Mean Difference (Net)|-0.159|STANDARD_ERROR_OF_MEAN|0.55||0.777|TWO_SIDED|95.0|-1.33|1.01||A priori threshold for statistical significance set at p\<.05.|t-test, 2 sided|Degrees of freedom = 25||This analysis is for the outcome: Change in child weekly intake of breakfast. It is an independent samples t test. It is testing the null hypothesis that the mean change in child breakfast meals per week from baseline to two-week follow up does not differ between conditions.||1.01|-1.33|.777
72368263|NCT04845568|144246354|SUPERIORITY||Mean Difference (Net)|-0.736|STANDARD_ERROR_OF_MEAN|0.74||0.329|TWO_SIDED|95.0|-2.26|0.79||A priori threshold for statistical significance set at p\<.05.|t-test, 2 sided|Degrees of freedom = 25||This analysis is for the outcome: Change in child intake of family dinners. It is an independent samples t test. It is testing the null hypothesis that the mean change in child family dinners per week from baseline to two-week follow up does not differ between conditions.||.79|-2.26|.329
72368264|NCT04845568|144246355|SUPERIORITY||Mean Difference (Net)|0.46|STANDARD_ERROR_OF_MEAN|0.26||0.086|TWO_SIDED|95.0|-0.07|0.99||A priori threshold for statistical significance set at p\<.05.|t-test, 2 sided|Degrees of freedom = 25||This analysis is for the outcome: Change in child screentime. It is an independent samples t test. It is testing the null hypothesis that the mean change in child screentime per week from baseline to two-week follow up does not differ between conditions.||.99|-0.07|.086
72368265|NCT04845568|144246355|SUPERIORITY||Mean Difference (Net)|-0.12|STANDARD_ERROR_OF_MEAN|0.25||0.64|TWO_SIDED|95.0|-0.64|0.4||A priori threshold for statistical significance set at p\<.05.|t-test, 2 sided|Degrees of freedom = 25||This analysis is for the outcome: Change in child active hours. It is an independent samples t test. It is testing the null hypothesis that the mean change in child active hours per week from baseline to two-week follow up does not differ between conditions.||.40|-.64|.64
72368266|NCT00354432|144246356|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3455|TWO_SIDED|||||This p-value is not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|A mixed effects repeated measures analysis of variance was used with the baseline means constrained to be equal in the four groups.||The null hypothesis was that there was no difference in the hot flash severity score at 12 weeks.||||.3455
72368267|NCT00354432|144246357|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2081|TWO_SIDED|||||This p-value is not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|ANCOVA|||Null hypothesis was that there was no difference in quality of life between the four groups at 12 weeks.||||0.2081
72368268|NCT01136980|144246385|SUPERIORITY||||||<|0.028|||||||Chi-squared|||||||<0.028
72368269|NCT01732718|144246389|SUPERIORITY|||||||0.51|||||||Student t-test followed by ANOVA|Student t-test subsequently followed by crossover ANOVA model testing carry-over effect and treatment effect||||||0.51
72368270|NCT01732718|144246390|SUPERIORITY|||||||0.74|||||||Wilcoxon (Mann-Whitney)|||||||0.74
72368271|NCT01732718|144246392|SUPERIORITY|||||||0.31|||||||Wilcoxon (Mann-Whitney)|||||||0.31
72368272|NCT01732718|144246394|SUPERIORITY|||||||0.57|||||||see comments for explanation|albuminuria examined as continuous variable (linear mixed model to analyze effect) and categorical generalized variable (estimating equation approach)||||||0.57
72368273|NCT01732718|144246398|SUPERIORITY|||||||0.64|||||||Wilcoxon (Mann-Whitney)|||||||0.64
72368274|NCT01732718|144246399|SUPERIORITY|||||||0.1469|||||||t-test, 1 sided|||Comparison of the change in AMC||||0.1469
72368275|NCT01732718|144246399|SUPERIORITY|||||||0.2382|||||||t-test, 1 sided|||Comparison of the change in ALC||||0.2382
72368276|NCT01732718|144246399|SUPERIORITY|||||||0.5833|||||||t-test, 1 sided|||Comparison of the change in ANC||||0.5833
72368277|NCT01732718|144246402|SUPERIORITY|||||||0.5184|||||||Wilcoxon (Mann-Whitney)|||||||0.5184
72368278|NCT02223702|144246408|SUPERIORITY_OR_OTHER||||||<|0.01|||||||Friedman Test|All rows were compared to eachother||||||<0.01
72368279|NCT02223702|144246409|SUPERIORITY_OR_OTHER||||||<|0.01|||||||ANOVA|All rows were compared to eachother||||||<0.01
72368280|NCT00499616|144246426|OTHER||Log Rank Test Statistic|0.9841||||0.3212|TWO_SIDED|95.0|||||Log Rank|||The event-free survival distributions of patients between 12-18 months of age with Stage 4 neuroblastoma and favorable biological features on ANBL0531 and patients less than 12 months of age with Stage 4 neuroblastoma on A3961 were compared using the log-rank test.||||.3212
72368281|NCT00499616|144246430|OTHER||Log-Rank Test Statistic|5.0049||||0.0253|TWO_SIDED|95.0|||||Log Rank|||The event-free survival distributions of patients with complete surgical resection and patients without complete surgical resection were compared using the log-rank test.||||.0253
72368282|NCT00499616|144246431|OTHER|The overall survival distributions of patients with complete surgical resection and patients without complete surgical resection were compared using the log-rank test.|Log Rank Test Statistic|2.6709||||0.1022|TWO_SIDED|95.0|||||Log Rank|||||||.1022
72368283|NCT00499616|144246432|OTHER||Chi-Square Test Statistic|9.9111||||0.0016|TWO_SIDED|95.0|||||Chi-squared|||The association between extent of surgical resection with occurrence of complications was determined using the chi-square test.||||.0016
72368284|NCT00539942|144246476|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.0|||<|0.05|||||||Chi-squared|||Unable to analyze data||||<.05
72368285|NCT00880919|144246478|SUPERIORITY_OR_OTHER|||||||0.015|||||||ANOVA|||Mean changes were calculated using each groups linear and quadratic effects||||.015
72368286|NCT00408200|144246512|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Fisher Exact|||||||<0.05
72368287|NCT02015637|144246516|NON_INFERIORITY|Two-sided 95% confidence intervals (CIs) using the Wald test was constructed for comparisons between delafloxacin and ceftriaxone. A hierarchical approach was implemented for the primary and secondary analyses to control for the overall type 1 error rate of 0.05 due to multiple comparisons.|Difference in cure rate|-5.9|||||TWO_SIDED|95.0|-13.18|1.36||||||||1.36|-13.18|
72368288|NCT02015637|144246517|NON_INFERIORITY|Two-sided 95% confidence intervals (CIs) using the Wald test was constructed for comparisons between delafloxacin and ceftriaxone. A hierarchical approach was implemented for the primary and secondary analyses to control for the overall type 1 error rate of 0.05 due to multiple comparisons.|Difference in cure rates|-9.9|||||TWO_SIDED|95.0|-16.03|-3.87||||||||-3.87|-16.03|
72368289|NCT02223858|144246520|SUPERIORITY|A sample size of 360 patients (180 non-Hispanic white and 180 non-Hispanic African American) was chosen based on a priori power calculations to detect a 3-way interaction between treatment group, race, and time, assuming a 20% change in baseline, the WOMAC pain subscales, and a 80% power.||||||0.791|||||||Mixed Models Analysis|All models adjusted for site.||||||0.791
72368290|NCT02223858|144246521|SUPERIORITY|A sample size of 360 (180 non-Hispanic white and 180 non-Hispanic African American) was chosen based on a priori power calculations to detect a 3-way interaction between treatment group, race, and time, assuming a 20% change in baseline, the WOMAC pain subscales, and a 80% power.||||||0.88|||||||Mixed Models Analysis|All models adjusted for site.||||||0.880
72368291|NCT02223858|144246522|SUPERIORITY|A sample size of 360 (180 non-Hispanic white and 180 non-Hispanic African American) was chosen based on a priori power calculations to detect a 3-way interaction between treatment group, race, and time, assuming a 20% change in baseline, the WOMAC pain subscale, and a 80% power.||||||0.901|||||||Mixed Models Analysis|All models adjusted for site.||||||0.901
72368292|NCT02106390|144246540|NON_INFERIORITY|Non-inferiority was to be concluded if, at one month following the fourth vaccination, the lower limits of the two-sided 95% confidence interval for the between-group ratios of GMTs (rMenB+OMV NZ + MenACWY versus rMenB+OMV NZ is \> 0.5 for all serogroup B indicator strains.|GMT ratio|0.89|||||TWO_SIDED|95.0|0.71|1.1|||ANOVA|The 2-sided 95% CI for each between groups ratio of GMTs was constructed from an analysis of ANOVA with vaccine group \& center as factors in the model||"H44/76- The comparison of adjusted GMTs ratio (rMenB+OMV NZ + MenACWY versus rMenB+OMV NZ) was performed for the H44/76 serogroup B indicator strain,at one month after the fourth vaccination."||1.10|0.71|
72368293|NCT02106390|144246540|NON_INFERIORITY|Non-inferiority was to be concluded if, at one month following the fourth vaccination, the lower limits of the two-sided 95% confidence interval for the between-group ratios of GMTs (rMenB+OMV NZ + MenACWY versus rMenB+OMV NZ is \> 0.5 for all serogroup B indicator strains.|GMT ratio|1.03|||||TWO_SIDED|95.0|0.74|1.45|||ANOVA|The 2-sided 95% CI for each between groups ratio of GMTs was constructed from an analysis of ANOVA with vaccine group \& center as factors in the model||5/99-The comparison of adjusted GMTs ratio (rMenB+OMV NZ + MenACWY versus rMenB+OMV NZ) was performed for the 5/99 serogroup B indicator strain,at one month after the fourth vaccination.||1.45|0.74|
72368294|NCT02106390|144246540|NON_INFERIORITY|Non-inferiority was to be concluded if, at one month following the fourth vaccination, the lower limits of the two-sided 95% confidence interval for the between-group ratios of GMTs (rMenB+OMV NZ + MenACWY versus rMenB+OMV NZ is \> 0.5 for all serogroup B indicator strains.|GMT ratio|1.01|||||TWO_SIDED|95.0|0.82|1.25|||ANOVA|The 2-sided 95% CI for each between groups ratio of GMTs was constructed from an analysis of ANOVA with vaccine group \& center as factors in the model||NZ98/254-The comparison of adjusted GMTs ratio (rMenB+OMV NZ + MenACWY versus rMenB+OMV NZ) was performed for the NZ98/254 serogroup B indicator strain,at one month after the fourth vaccination.||1.25|0.82|
72368295|NCT02106390|144246540|NON_INFERIORITY|Non-inferiority was to be concluded if, at one month following the fourth vaccination, the lower limits of the two-sided 95% confidence interval for the between-group ratios of GMTs (rMenB+OMV NZ + MenACWY versus rMenB+OMV NZ is \> 0.5 for all serogroup B indicator strains.|GMT ratio|1.03|||||TWO_SIDED|95.0|0.77|1.4|||ANOVA|The 2-sided 95% CI for each between groups ratio of GMTs was constructed from an analysis of ANOVA with vaccine group \& center as factors in the model||M10713-The comparison of adjusted GMTs ratio (rMenB+OMV NZ + MenACWY versus rMenB+OMV NZ) was performed for the M10713 serogroup B indicator strain,at one month after the fourth vaccination.||1.40|0.77|
72368296|NCT02106390|144246541|NON_INFERIORITY|Non-inferiority was to be concluded if, at one month following the fourth vaccination, the lower limits of the two-sided 95% confidence interval for the between-group ratios of GMTs (rMenB+OMVNZ + MenACWY versus MenACWY) was \> 0.5 for all serogroups A, C, W-135 and Y.|GMT ratio|2.48|||||TWO_SIDED|95.0|1.97|3.11|||ANOVA|The 2-sided 95% CI for each between groups ratio of GMTs was constructed from an analysis of ANOVA with vaccine group \& center as factors in the model||Serogroup A-The comparison of adjusted GMTs ratio (rMenB+OMV NZ + Men ACWY versus MenACWY) was performed for serogroup A at one month after the fourth vaccination.||3.11|1.97|
72368297|NCT02106390|144246541|NON_INFERIORITY|Non-inferiority was to be concluded if, at one month following the fourth vaccination, the lower limits of the two-sided 95% confidence interval for the between-group ratios of GMTs (rMenB+OMVNZ + MenACWY versus MenACWY) was \> 0.5 for all serogroups A, C, W-135 and Y.|GMT ratio|1.07|||||TWO_SIDED|95.0|0.83|1.38|||ANOVA|The 2-sided 95% CI for each between groups ratio of GMTs was constructed from an analysis of ANOVA with vaccine group \& center as factors in the model||Serogroup C-The comparison of adjusted GMTs ratio (rMenB+OMV NZ + Men ACWY versus MenACWY) was performed for the serogroup C at one month after the fourth vaccination.||1.38|0.83|
72368298|NCT02106390|144246541|NON_INFERIORITY|Non-inferiority was to be concluded if, at one month following the fourth vaccination, the lower limits of the two-sided 95% confidence interval for the between-group ratios of GMTs (rMenB+OMVNZ + MenACWY versus MenACWY) was \> 0.5 for all serogroups A, C, W-135 and Y.|GMT ratio|1.34|||||TWO_SIDED|95.0|1.04|1.74|||ANOVA|The 2-sided 95% CI for each between groups ratio of GMTs was constructed from an analysis of ANOVA with vaccine group \& center as factors in the model||Serogroup W-The comparison of adjusted GMTs ratio (rMenB+OMV NZ + Men ACWY versus MenACWY) was performed for the serogroup W-135 at one month after the fourth vaccination.||1.74|1.04|
72368299|NCT02106390|144246541|NON_INFERIORITY|Non-inferiority was to be concluded if, at one month following the fourth vaccination, the lower limits of the two-sided 95% confidence interval for the between-group ratios of GMTs (rMenB+OMVNZ + MenACWY versus MenACWY) was \> 0.5 for all serogroups A, C, W-135 and Y.|GMT ratio|1.05|||||TWO_SIDED|95.0|0.82|1.35|||ANOVA|The 2-sided 95% CI for each between groups ratio of GMTs was constructed from an analysis of ANOVA with vaccine group \& center as factors in the model||Serogroup Y-The comparison of adjusted GMTs ratio (rMenB+OMV NZ + Men ACWY versus MenACWY) was performed for the serogroup Y at one month after the fourth vaccination.||1.35|0.82|
72368300|NCT03198507|144246573|SUPERIORITY|||||||0.0001|TWO_SIDED|95.0||||Statistical testing was 2 sided and performed using a significance (alpha) level of 0.05.|t-test, 2 sided|||||||0.0001
72368301|NCT03198507|144246576|SUPERIORITY|||||||0.0001|||||||t-test, 2 sided|||||||0.0001
72368302|NCT00241839|144246584|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.27|STANDARD_ERROR_OF_MEAN|2.24||0.059|TWO_SIDED|95.0|-0.17|8.7|||t-test, 2 sided|Satterthwaite correction for possibly unequal variance was made|A positive value of the estimated value would favor the allopurinol arm. The analysis is limited to those with both baseline and 8-10 week data on this variable.|We compared the drop in baseline of diastolic BP for the two treatment groups Allopurinol vs. Placebo by a Satterthwaite corrected t-test.||8.7|-0.17|0.059
72368303|NCT00241839|144246585|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.16|STANDARD_ERROR_OF_MEAN|1.59||0.47|TWO_SIDED|95.0|-2.0|4.3||Positive numbers indicate a drop. We compared baseline minus value at treatment end for the two treatments.|t-test, 2 sided|Satterthwaite correction was used for potentially unequal variances.|The analysis is limited to those with both baseline and 8-10 week data on this variable.|||4.3|-2.0|0.47
72368304|NCT00241839|144246586|SUPERIORITY_OR_OTHER||Median Difference (Net)|-6.76|STANDARD_ERROR_OF_MEAN|2.11||0.002|TWO_SIDED|95.0|-11.0|-2.6|||t-test, 2 sided|Sattherthwaite correction was used|The analysis is limited to those with both baseline and 8-10 week data on this variable. The 24 hour was in the opposite direction of the cuff.|||-2.6|-11.0|0.0020
72368305|NCT00241839|144246587|SUPERIORITY_OR_OTHER||Median Difference (Net)|2.15|STANDARD_ERROR_OF_MEAN|0.22|<|0.001|TWO_SIDED|95.0|1.72|2.59|||t-test, 2 sided|Satterthwaite correction was used.|Allopurinol was associated with a significant decrease in uric acid over the treatment period as compared to placebo. The analysis is limited to those with both baseline and 8-10 week data on this variable.|We expected allopurinol to be associated with a decrease in uric acid.||2.59|1.72|<0.001
72368306|NCT02863419|144246597|NON_INFERIORITY|This hypothesis was controlled for multiplicity. Results are based on the data from the in-trial observation period. The estimated treatment effect includes the effect of any rescue medication and any effect after premature trial product discontinuation (treatment policy estimand). A value of 0.4% (the non-inferiority margin) was added to imputed values at week 26 for the oral semaglutide treatment arm only.|Mean treatment difference|-0.1|||<|0.0001|TWO_SIDED|95.0|-0.3|0.0||Unadjusted two-sided p-value for test of no difference from the non-inferiority margin. The non-inferiority margin was 0.4%|Pattern mixture model||Oral semaglutide 14 mg - Liraglutide 1.8 mg|The analysis was based on a pattern mixture model using multiple imputation to handle missing week 26 data, assuming that data were missing at random within the groups used for imputation. The imputed data sets were analysed using an analysis of covariance (ANCOVA) model with treatment, strata, and region as categorical fixed effects and baseline HbA1c value as covariate for each of the 1000 imputed complete data sets, and pooled by Rubin's rule to draw inference.||0.0|-0.3|<0.0001
72368307|NCT02863419|144246597|SUPERIORITY|This hypothesis was controlled for multiplicity. Results are based on the data from the in-trial observation period. The estimated treatment effect includes the effect of any rescue medication and any effect after premature trial product discontinuation (treatment policy estimand).|Mean treatment difference|-0.1||||0.0645|TWO_SIDED|95.0|-0.3|0.0||Unadjusted two-sided p-value for test of no difference from 0 (superiority).|Pattern mixture model||Oral semaglutide 14 mg - Liraglutide 1.8 mg|The analysis was based on a pattern mixture model using multiple imputation to handle missing week 26 data, assuming that data were missing at random within the groups used for imputation. The imputed data sets were analysed using an ANCOVA model with treatment, strata, and region as categorical fixed effects and baseline HbA1c value as covariate for each of the 1000 imputed complete data sets, and pooled by Rubin's rule to draw inference.||0.0|-0.3|0.0645
72368308|NCT02863419|144246597|SUPERIORITY|This hypothesis was controlled for multiplicity. Results are based on the data from the in-trial observation period. The estimated treatment effect includes the effect of any rescue medication and any effect after premature trial product discontinuation (treatment policy estimand).|Mean treatment difference|-1.1|||<|0.0001|TWO_SIDED|95.0|-1.2|-0.9||Unadjusted two-sided p-value for test of no difference from 0 (superiority).|Pattern mixture model||Oral semaglutide 14 mg - Placebo|The analysis was based on a pattern mixture model using multiple imputation to handle missing week 26 data, assuming that data were missing at random within the groups used for imputation. The imputed data sets were analysed using an ANCOVA model with treatment, strata, and region as categorical fixed effects and baseline HbA1c value as covariate for each of the 1000 imputed complete data sets, and pooled by Rubin's rule to draw inference.||-0.9|-1.2|<0.0001
72368309|NCT02863419|144246597|NON_INFERIORITY|This hypothesis was not controlled for multiplicity. Results are based on the data from the on-treatment without rescue medication observation period. The estimated treatment effect excludes the effect of any rescue medication and any effect after premature trial product discontinuation (hypothetical estimand).|Mean treatment difference|-0.2|||<|0.0001|TWO_SIDED|95.0|-0.3|-0.1||Unadjusted two-sided p-value for test of no difference from the non-inferiority margin (non-inferiority). The non-inferiority margin was 0.4%.|MMRM||Oral semaglutide 14 mg - Liraglutide 1.8 mg|The analysis was based on a mixed model for repeated measurements (MMRM) that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 26. The independent effects were treatment, strata and region as categorical fixed effects and the baseline HbA1c value as a covariate, all nested within visit, and an unstructured residual covariance matrix.||-0.1|-0.3|<0.0001
72368310|NCT02863419|144246597|SUPERIORITY|This hypothesis was not controlled for multiplicity. Results are based on the data from the on-treatment without rescue medication observation period. The estimated treatment effect excludes the effect of any rescue medication and any effect after premature trial product discontinuation (hypothetical estimand).|Mean treatment difference|-0.2||||0.0056|TWO_SIDED|95.0|-0.3|-0.1||Unadjusted two-sided p-value for test of no difference from 0 (superiority).|MMRM||Oral semaglutide 14 mg - Liraglutide 1.8 mg|The analysis was based on a mixed model for repeated measurements (MMRM) that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 26. The independent effects were treatment, strata and region as categorical fixed effects and the baseline HbA1c value as a covariate, all nested within visit, and an unstructured residual covariance matrix.||-0.1|-0.3|0.0056
72368817|NCT02637037|144247321|NON_INFERIORITY_OR_EQUIVALENCE|If the 90% CIs for both dapagliflozin and metformin geometric mean ratio of AUC is entirely contained within an 80.00% to 125.00% interval, it will be concluded the 2 manufacturing sites are bioequivalent.|Ratios of Geometric means|1.01|||||TWO_SIDED|90.0|0.96|1.07||||||Metformin: Statistical Assessment of Bioequivalence for Metformin following administration Dapagliflozin/Metformin XR 5/500 mg for Treatment A and B.||1.07|0.96|
72368311|NCT02863419|144246597|SUPERIORITY|This hypothesis was not controlled for multiplicity. Results are based on the data from the on-treatment without rescue medication observation period. The estimated treatment effect excludes the effect of any rescue medication and any effect after premature trial product discontinuation (hypothetical estimand).|Mean treatment difference|-1.2||||0.0001|TWO_SIDED|95.0|-1.4|-1.0||Unadjusted two-sided p-value for test of no difference from 0 (superiority).|MMRM||Oral semaglutide 14 mg - Placebo|The analysis was based on a mixed model for repeated measurements (MMRM) that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 26. The independent effects were treatment, strata and region as categorical fixed effects and the baseline HbA1c value as a covariate, all nested within visit, and an unstructured residual covariance matrix.||-1.0|-1.4|0.0001
72368312|NCT02863419|144246598|SUPERIORITY|This hypothesis was controlled for multiplicity. Results are based on the data from the in-trial observation period. The estimated treatment effect includes the effect of any rescue medication and any effect after premature trial product discontinuation (treatment policy estimand).|Mean treatment difference|-1.2||||0.0003|TWO_SIDED|95.0|-1.9|-0.6||Unadjusted two-sided p-value for test of no difference from 0 (superiority).|Pattern mixture model||Oral semaglutide 14 mg - Liraglutide 1.8 mg|The analysis was based on a pattern mixture model using multiple imputation to handle missing week 26 data, assuming that data were missing at random within the groups used for imputation. The imputed data sets were analysed using an ANCOVA model with treatment, strata, and region as categorical fixed effects and baseline body weight value as covariate for each of the 1000 imputed complete data sets, and pooled by Rubin's rule to draw inference.||-0.6|-1.9|0.0003
72368313|NCT02863419|144246598|SUPERIORITY|This hypothesis was controlled for multiplicity. Results are based on the data from the in-trial observation period. The estimated treatment effect includes the effect of any rescue medication and any effect after premature trial product discontinuation (treatment policy estimand).|Mean treatment difference|-3.8|||<|0.0001|TWO_SIDED|95.0|-4.7|-3.0||Unadjusted two-sided p-value for test of no difference from 0 (superiority).|Pattern mixture model||Oral semaglutide 14 mg - Placebo|The analysis was based on a pattern mixture model using multiple imputation to handle missing week 26 data, assuming that data were missing at random within the groups used for imputation. The imputed data sets were analysed using an ANCOVA model with treatment, strata, and region as categorical fixed effects and baseline body weight value as covariate for each of the 1000 imputed complete data sets, and pooled by Rubin's rule to draw inference.||-3.0|-4.7|<0.0001
72368314|NCT02863419|144246598|SUPERIORITY|This hypothesis was not controlled for multiplicity. Results are based on the data from the on-treatment without rescue medication observation period. The estimated treatment effect excludes the effect of any rescue medication and any effect after premature trial product discontinuation (hypothetical estimand).|Mean treatment difference|-1.5|||<|0.0001|TWO_SIDED|95.0|-2.2|-0.9||Unadjusted two-sided p-value for test of no difference from 0 (superiority).|MMRM||Oral semaglutide 14 mg - Liraglutide 1.8 mg|The analysis was based on a MMRM that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 26. The independent effects were treatment, strata and region as categorical fixed effects and the baseline body weight value as a covariate, all nested within visit, and an unstructured residual covariance matrix.||-0.9|-2.2|<0.0001
72368315|NCT02863419|144246598|SUPERIORITY|This hypothesis was not controlled for multiplicity. Results are based on the data from the on-treatment without rescue medication observation period. The estimated treatment effect excludes the effect of any rescue medication and any effect after premature trial product discontinuation (hypothetical estimand).|Mean treatment difference|-4.0|||<|0.0001|TWO_SIDED|95.0|-4.8|-3.2||Unadjusted two-sided p-value for test of no difference from 0 (superiority).|MMRM||Oral sema 14 mg - Placebo|The analysis was based on a MMRM that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 26. The independent effects were treatment, strata and region as categorical fixed effects and the baseline body weight value as a covariate, all nested within visit, and an unstructured residual covariance matrix.||-3.2|-4.8|<0.0001
72368316|NCT02863419|144246619|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|1.17||||0.4915|TWO_SIDED|95.0|0.75|1.8||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox||Oral semaglutide 14 mg / Liraglutide 1.8 mg|Time to initiation of additional anti-diabetic medication was analysed using a Cox proportional hazards model with treatment, strata, and region as categorical fixed effects and baseline HbA1c as covariate. Withdrawal for any reason or lost to follow-up contributed to the analysis as events (initiation of additional anti-diabetic medication). Censoring time was one day before planned end of treatment.||1.80|0.75|0.4915
72368317|NCT02863419|144246619|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|0.32|||<|0.0001|TWO_SIDED|95.0|0.21|0.48||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox||Oral semaglutide 14 mg / Placebo|Time to initiation of additional anti-diabetic medication was analysed using a Cox proportional hazards model with treatment, strata, and region as categorical fixed effects and baseline HbA1c as covariate. Withdrawal for any reason or lost to follow-up contributed to the analysis as events (initiation of additional anti-diabetic medication). Censoring time was one day before planned end of treatment.||0.48|0.21|<0.0001
72368318|NCT02863419|144246620|SUPERIORITY|This hypothesis was not controlled for multiplicity|Hazard Ratio (HR)|1.17||||0.6252|TWO_SIDED|95.0|0.62|2.22||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox||Oral semaglutide 14 mg / Liraglutide 1.8 mg|Time to initiation of rescue medication was analysed using a Cox proportional hazards model with treatment, strata, and region as categorical fixed effects and baseline HbA1c as covariate. Censoring time was one day before last day on trial product.||2.22|0.62|0.6252
72368319|NCT02863419|144246620|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|0.15|||<|0.0001|TWO_SIDED|95.0|0.09|0.26||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox||Oral semaglutide 14 mg / Placebo|Time to initiation of rescue medication was analysed using a Cox proportional hazards model with treatment, strata, and region as categorical fixed effects and baseline HbA1c as covariate. Censoring time was one day before last day on trial product.||0.26|0.09|<0.0001
72553331|NCT02760368|144638128|SUPERIORITY||Risk Difference (RD)|0.084|||<|0.0002|TWO_SIDED|97.5|0.032|0.151||2x2 chi-square test|Chi-squared|||||0.151|0.032|<0.0002
72553332|NCT02760368|144638128|SUPERIORITY||Risk Difference (RD)|0.077|||<|0.0003|TWO_SIDED|97.5|0.027|0.143||2x2 chi-square test|Chi-squared|||||0.143|0.027|<0.0003
72368320|NCT03511937|144246651|SUPERIORITY||Mean Difference (Final Values)|-31.4||||0.02|TWO_SIDED|95.0|-57.9|-5.0||The a priori threshold for statistical significance was \< 0.05.|Two-part regression model with robust SE|Analyses controlled for overweight/obese status and Hispanic ethnicity, which were unbalanced between arms, and estimated Huber-White robust SEs.||||-5.0|-57.9|0.02
72368321|NCT03511937|144246652|SUPERIORITY||Mean Difference (Final Values)|-69.4||||0.55|TWO_SIDED|95.0|-295.5|156.6||The a priori threshold for statistical significance was \< 0.05.|Regression, Linear|Analyses controlled for overweight/obese status and Hispanic ethnicity, which were unbalanced between arms, and estimated Huber-White robust SEs.||||156.6|-295.5|0.55
72368322|NCT03511937|144246653|SUPERIORITY||Mean Difference (Final Values)|-13.0||||0.006|TWO_SIDED|95.0|-23.0|-4.0||The a priori threshold for statistical significance was \< 0.05.|Regression, Logistic|Analyses controlled for overweight/obesity status and Hispanic ethnicity, which were unbalanced between treatment arms.|Analyses used logistic regression to calculate mean difference in predicted probability of purchasing a sugar-sweetened beverage.|||-4|-23|0.006
72368323|NCT03511937|144246654|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.01|TWO_SIDED|95.0|-0.4|-0.1||The a priori threshold for statistical significance was \< 0.05.|Negative binomial regression|Analyses controlled for overweight/obesity status and Hispanic ethnicity, which were unbalanced between arms, and estimated Huber-White robust SEs.||||-0.1|-0.4|0.010
72368324|NCT03511937|144246655|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.403|TWO_SIDED|95.0|-0.2|0.5||The a priori threshold for statistical significance was \< 0.05.|Regression, Linear|Analyses controlled for obesity status and Hispanic ethnicity, which were unbalanced between arms, and estimated Huber-White robust standard errors.||||0.5|-0.2|0.403
72368325|NCT03511937|144246656|SUPERIORITY||Mean Difference (Final Values)|0.4||||0.005|TWO_SIDED|95.0|0.1|0.8||The a priori threshold for statistical significance was \< 0.05.|Regression, Linear|Analyses controlled for overweight/obese status and Hispanic ethnicity, which were unbalanced between arms, and estimated Huber-White robust SEs.||||0.8|0.1|0.005
72368326|NCT03511937|144246657|SUPERIORITY||Mean Difference (Final Values)|37.0|||<|0.001|TWO_SIDED|95.0|32.0|43.0||The a priori threshold for statistical significance was \< 0.05.|Regression, Logistic|Analyses controlled for overweight/obese status and Hispanic ethnicity, which were unbalanced between treatment arms.|Analyses used logistic regression to calculate mean difference in predicted probability of purchasing a sugar-sweetened beverage.|||43|32|<0.001
72368327|NCT03511937|144246658|SUPERIORITY||Mean Difference (Final Values)|1.7|||<|0.001|TWO_SIDED|95.0|1.4|1.9||The a priori threshold for statistical significance was \< 0.05.|Regression, Linear|Analyses controlled for overweight/obese status and Hispanic ethnicity, which were unbalanced between arms, and estimated Huber-White robust SEs.||||1.9|1.4|<0.001
72368328|NCT03511937|144246659|SUPERIORITY||Mean Difference (Final Values)|0.4|||<|0.001|TWO_SIDED|95.0|0.3|0.5||The a priori threshold for statistical significance was \< 0.05.|Regression, Linear|Analyses controlled for overweight/obese status and Hispanic ethnicity, which were unbalanced between arms, and estimated Huber-White robust SEs.||||0.5|0.3|<0.001
72368329|NCT03511937|144246660|SUPERIORITY||Mean Difference (Final Values)|1.1|||<|0.001|TWO_SIDED|95.0|0.9|1.3||The a priori threshold for statistical significance was \< 0.05.|Regression, Linear|Analyses controlled for overweight/obese status and Hispanic ethnicity, which were unbalanced between arms, and estimated Huber-White robust SEs.||||1.3|0.9|<0.001
72368330|NCT03511937|144246661|SUPERIORITY||Mean Difference (Final Values)|0.9|||<|0.001|TWO_SIDED|95.0|0.7|1.1||The a priori threshold for statistical significance was \< 0.05.|Regression, Linear|Analyses controlled for overweight/obese status and Hispanic ethnicity, which were unbalanced between arms, and estimated Huber-White robust SEs.||||1.1|0.7|<0.001
72368331|NCT03511937|144246662|SUPERIORITY||Mean Difference (Final Values)|0.07||||0.055|TWO_SIDED|95.0|-0.001|0.13||The a priori threshold for statistical significance was \< 0.05.|Regression, Linear|Analyses controlled for overweight/obese status and Hispanic ethnicity, which were unbalanced between arms, and estimated Huber-White robust SEs.||||0.13|-0.001|0.055
72368332|NCT03511937|144246663|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.258|TWO_SIDED|95.0|-0.27|0.07||The a priori threshold for statistical significance was \< 0.05.|Regression, Linear|Analyses controlled for overweight/obese status and Hispanic ethnicity, which were unbalanced between arms, and estimated Huber-White robust SEs.||||0.07|-0.27|0.258
72368333|NCT03511937|144246664|SUPERIORITY||Mean Difference (Final Values)|-0.09||||0.416|TWO_SIDED|95.0|-0.3|0.13||The a priori threshold for statistical significance was \< 0.05.|Regression, Linear|Analyses controlled for overweight/obese status and Hispanic ethnicity, which were unbalanced between arms, and estimated Huber-White robust SEs.||||0.13|-0.30|0.416
72368334|NCT03511937|144246665|SUPERIORITY||Mean Difference (Final Values)|0.05||||0.609|TWO_SIDED|95.0|-0.14|0.24||The a priori threshold for statistical significance was \< 0.05.|Regression, Linear|Analyses controlled for overweight/obese status and Hispanic ethnicity, which were unbalanced between arms, and estimated Huber-White robust SEs.||||0.24|-0.14|0.609
72368335|NCT03511937|144246666|SUPERIORITY||Mean Difference (Final Values)|0.3||||0.002|TWO_SIDED|95.0|0.1|0.5||The a priori threshold for statistical significance was \< 0.05.|Regression, Linear|Analyses controlled for overweight/obese status and Hispanic ethnicity, which were unbalanced between arms, and estimated Huber-White robust SEs.||||0.5|0.1|0.002
72368336|NCT03511937|144246667|SUPERIORITY||Mean Difference (Final Values)|2.1|||<|0.001|TWO_SIDED|95.0|1.8|2.3||The a priori threshold for statistical significance was \< 0.05.|Regression, Linear|Analyses controlled for overweight/obese status and Hispanic ethnicity, which were unbalanced between arms, and estimated Huber-White robust SEs.||||2.3|1.8|<0.001
72368337|NCT03511937|144246668|SUPERIORITY||Mean Difference (Final Values)|-0.08||||0.311|TWO_SIDED|95.0|-0.23|0.07||The a priori threshold for statistical significance was \< 0.05.|Regression, Linear|Analyses controlled for overweight/obese status and Hispanic ethnicity, which were unbalanced between arms, and estimated Huber-White robust SEs.||||0.07|-0.23|0.311
72368338|NCT03511937|144246669|SUPERIORITY||Mean Difference (Final Values)|-0.11||||0.253|TWO_SIDED|95.0|-0.3|0.08||The a priori threshold for statistical significance was \< 0.05.|Regression, Linear|Analyses controlled for overweight/obese status and Hispanic ethnicity, which were unbalanced between arms, and estimated Huber-White robust SEs.||||0.08|-0.30|0.253
72368339|NCT03511937|144246670|SUPERIORITY||Mean Difference (Final Values)|-0.04||||0.658|TWO_SIDED|95.0|-0.22|0.14||The a priori threshold for statistical significance was \< 0.05.|Regression, Linear|Analyses controlled for overweight/obese status and Hispanic ethnicity, which were unbalanced between arms, and estimated Huber-White robust SEs.||||0.14|-0.22|0.658
72553333|NCT01860521|144638135|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||||||< 0.001
72553334|NCT01860521|144638136|SUPERIORITY_OR_OTHER|||||||0.005||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.005
72553335|NCT01860521|144638137|SUPERIORITY_OR_OTHER|||||||0.047||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.047
72553336|NCT01860521|144638138|SUPERIORITY_OR_OTHER|||||||0.047||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.047
72553337|NCT02757105|144638150|SUPERIORITY|||||||0.036|||||||Chi-squared, Corrected|||||||0.036
72553338|NCT02757105|144638151|SUPERIORITY|||||||0.41|||||||Chi-squared, Corrected|||||||0.410
72553339|NCT02757105|144638152|SUPERIORITY|||||||0.081|||||||Chi-squared, Corrected|||||||0.081
72553340|NCT02757105|144638153|SUPERIORITY|||||||0.042|||||||Chi-squared, Corrected|||||||0.042
72553341|NCT02757105|144638154|SUPERIORITY|||||||0.009|||||||Chi-squared, Corrected|||||||0.009
72553342|NCT02757105|144638155|SUPERIORITY|||||||0.919|||||||Chi-squared, Corrected|||||||0.919
72553343|NCT02757105|144638156|SUPERIORITY||Mean Difference (Final Values)|11.5||||0.278|TWO_SIDED|95.0|-7.7|30.6|||Chi-squared, Corrected|||||30.6|-7.7|0.278
72553344|NCT02757105|144638157|SUPERIORITY||Mean Difference (Final Values)|14.5||||0.135|TWO_SIDED|95.0|-3.4|32.5|||Chi-squared, Corrected|||||32.5|-3.4|0.135
72553345|NCT00473330|144638170|SUPERIORITY_OR_OTHER||Difference in percentage at Month 24|24.3|||<|0.0001|TWO_SIDED|95.0|13.8|34.8||An adjustment was made for multiple treatment comparisons of the ranibizumab dose groups with the control group.|Cochran-Mantel-Haenszel|The analysis was stratified by baseline BCVA score (≤55, \>55 letters), baseline HbA1c (≤8%, \>8%), and prior therapy for ME in the study eye (yes, no).|The percentage for each group and the difference in percentage between groups were estimated using the weighted average of the observed percentages and the differences in observed percentages over the strata using the Cochran-Mantel-Haenszel weights.|||34.8|13.8|<0.0001
72553346|NCT00473330|144638170|SUPERIORITY_OR_OTHER||Difference in percentage at Month 24|20.9||||0.0002|TWO_SIDED|95.0|10.7|31.1||An adjustment was made for multiple treatment comparisons of the ranibizumab dose groups with the control group.|Cochran-Mantel-Haenszel|The analysis was stratified by baseline BCVA score (≤55, \>55 letters), baseline HbA1c (≤8%, \>8%), and prior therapy for ME in the study eye (yes, no).|The percentage for each group and the difference in percentage between groups were estimated using the weighted average of the observed percentages and the differences in observed percentages over the strata using the Cochran-Mantel-Haenszel weights.|||31.1|10.7|0.0002
72553347|NCT00473330|144638171|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.6|||<|0.0001|TWO_SIDED|95.0|6.1|13.0||To manage the type I error rate while testing multiple secondary efficacy endpoints for statistical significance, a type I error management plan was implemented. Secondary endpoints were prioritized and tested using a hierarchical testing procedure.|ANOVA|The analysis was stratified by baseline BCVA score (≤55, \>55 letters), baseline HbA1c (≤8%, \>8%), and prior therapy for ME in the study eye (yes, no).||The analysis summarized in this section is for the Month 24 time point, comparing the outcome for patients randomized to ranibizumab versus sham injections during the controlled treatment period. The statistical analysis for the Outcome Measure at Month 36 is not shown here. The statistical analysis was not performed at Month 48.||13.0|6.1|<0.0001
72553348|NCT00473330|144638171|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.4|||<|0.0001|TWO_SIDED|95.0|6.2|12.6||To manage the type I error rate while testing multiple secondary efficacy endpoints for statistical significance, a type I error management plan was implemented. Secondary endpoints were prioritized and tested using a hierarchical testing procedure.|ANOVA|The analysis was stratified by baseline BCVA score (≤55, \>55 letters), baseline HbA1c (≤8%, \>8%), and prior therapy for ME in the study eye (yes, no).||The analysis summarized in this section is for the Month 24 time point, comparing the outcome for patients randomized to ranibizumab versus sham injections during the controlled treatment period. The statistical analysis for the Outcome Measure at Month 36 is not shown here. The statistical analysis was not performed at Month 48.||12.6|6.2|<0.0001
72553349|NCT00473330|144638172|SUPERIORITY_OR_OTHER||Difference in percentage at Month 24|24.4|||<|0.0001|TWO_SIDED|95.0|13.4|35.4||To manage the type I error rate while testing multiple secondary efficacy endpoints for statistical significance, a type I error management plan was implemented. Secondary endpoints were prioritized and tested using a hierarchical testing procedure.|Cochran-Mantel-Haenszel|The analysis was stratified by baseline BCVA score (≤55, \>55 letters), baseline HbA1c (≤8%, \>8%), and prior therapy for ME in the study eye (yes, no).|The percentage for each group and the difference in percentage between groups were estimated using the weighted average of the observed percentages and the differences in observed percentages over the strata using the Cochran-Mantel-Haenszel weights.|The analysis summarized in this section is for the Month 24 time point, comparing the outcome for patients randomized to ranibizumab versus sham injections during the controlled treatment period. The statistical analysis for the Outcome Measure at Month 36 is not shown here. The statistical analysis was not performed at Month 48.||35.4|13.4|<0.0001
72553350|NCT00473330|144638172|SUPERIORITY_OR_OTHER||Difference in percentage at Month 24|25.1|||<|0.0001|TWO_SIDED|95.0|14.0|36.3||To manage the type I error rate while testing multiple secondary efficacy endpoints for statistical significance, a type I error management plan was implemented. Secondary endpoints were prioritized and tested using a hierarchical testing procedure.|Cochran-Mantel-Haenszel|The analysis was stratified by baseline BCVA score (≤55, \>55 letters), baseline HbA1c (≤8%, \>8%), and prior therapy for ME in the study eye (yes, no).|The percentage for each group and the difference in percentage between groups were estimated using the weighted average of the observed percentages and the differences in observed percentages over the strata using the Cochran-Mantel-Haenszel weights.|The analysis summarized in this section is for the Month 24 time point, comparing the outcome for patients randomized to ranibizumab versus sham injections during the controlled treatment period. The statistical analysis for the Outcome Measure at Month 36 is not shown here. The statistical analysis was not performed at Month 48.||36.3|14.0|<0.0001
72553351|NCT00473330|144638173|SUPERIORITY_OR_OTHER||Difference in percentage at Month 24|8.2||||0.0086|TWO_SIDED|95.0|2.4|14.1||To manage the type I error rate while testing multiple secondary efficacy endpoints for statistical significance, a type I error management plan was implemented. Secondary endpoints were prioritized and tested using a hierarchical testing procedure.|Cochran-Mantel-Haenszel|The analysis was stratified by baseline BCVA score (≤55, \>55 letters), baseline HbA1c (≤8%, \>8%), and prior therapy for ME in the study eye (yes, no).|The percentage for each group and the difference in percentage between groups were estimated using the weighted average of the observed percentages and the differences in observed percentages over the strata using the Cochran-Mantel-Haenszel weights.|The analysis summarized in this section is for the Month 24 time point, comparing the outcome for patients randomized to ranibizumab versus sham injections during the controlled treatment period. The statistical analysis for the Outcome Measure at Month 36 is not shown here. The statistical analysis was not performed at Month 48.||14.1|2.4|0.0086
72553352|NCT00473330|144638173|SUPERIORITY_OR_OTHER||Difference in percentage at Month 24|7.8||||0.0126|TWO_SIDED|95.0|2.0|13.6||To manage the type I error rate while testing multiple secondary efficacy endpoints for statistical significance, a type I error management plan was implemented. Secondary endpoints were prioritized and tested using a hierarchical testing procedure.|Cochran-Mantel-Haenszel|The analysis was stratified by baseline BCVA score (≤55, \>55 letters), baseline HbA1c (≤8%, \>8%), and prior therapy for ME in the study eye (yes, no).|The percentage for each group and the difference in percentage between groups were estimated using the weighted average of the observed percentages and the differences in observed percentages over the strata using the Cochran-Mantel-Haenszel weights.|The analysis summarized in this section is for the Month 24 time point, comparing the outcome for patients randomized to ranibizumab versus sham injections during the controlled treatment period. The statistical analysis for the Outcome Measure at Month 36 is not shown here. The statistical analysis was not performed at Month 48.||13.6|2.0|0.0126
72553353|NCT00473330|144638174|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.7||||0.0005|TWO_SIDED|95.0|4.3|15.1||To manage the type I error rate while testing multiple secondary efficacy endpoints for statistical significance, a type I error management plan was implemented. Secondary endpoints were prioritized and tested using a hierarchical testing procedure.|ANOVA|The analysis was stratified by baseline BCVA score (≤55, \>55 letters), baseline HbA1c (≤8%, \>8%), and prior therapy for ME in the study eye (yes, no).||The analysis summarized in this section is for the Month 24 time point, comparing the outcome for patients randomized to ranibizumab versus sham injections during the controlled treatment period. The statistical analysis for the Outcome Measure at Month 36 is not shown here.||15.1|4.3|0.0005
72553354|NCT00473330|144638174|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.2||||0.0011|TWO_SIDED|95.0|3.3|13.0||To manage the type I error rate while testing multiple secondary efficacy endpoints for statistical significance, a type I error management plan was implemented. Secondary endpoints were prioritized and tested using a hierarchical testing procedure.|ANOVA|The analysis was stratified by baseline BCVA score (≤55, \>55 letters), baseline HbA1c (≤8%, \>8%), and prior therapy for ME in the study eye (yes, no).||The analysis summarized in this section is for the Month 24 time point, comparing the outcome for patients randomized to ranibizumab versus sham injections during the controlled treatment period. The statistical analysis for the Outcome Measure at Month 36 is not shown here.||13.0|3.3|0.0011
72553355|NCT00473330|144638175|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-107.9|||<|0.0001|TWO_SIDED|95.0|-149.2|-66.6||To manage the type I error rate while testing multiple secondary efficacy endpoints for statistical significance, a type I error management plan was implemented. Secondary endpoints were prioritized and tested using a hierarchical testing procedure.|ANCOVA|The analysis was stratified by baseline BCVA score (≤55, \>55 letters), baseline HbA1c (≤8%, \>8%), and prior therapy for ME in the study eye (yes, no).||The analysis summarized in this section is for the Month 24 time point, comparing the outcome for patients randomized to ranibizumab versus sham injections during the controlled treatment period. The statistical analysis for the Outcome Measure at Month 36 is not shown here. The statistical analysis was not performed at Month 48.||-66.6|-149.2|<0.0001
72553356|NCT00473330|144638175|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-119.1|||<|0.0001|TWO_SIDED|95.0|-159.6|-78.5||To manage the type I error rate while testing multiple secondary efficacy endpoints for statistical significance, a type I error management plan was implemented. Secondary endpoints were prioritized and tested using a hierarchical testing procedure.|ANCOVA|The analysis was stratified by baseline BCVA score (≤55, \>55 letters), baseline HbA1c (≤8%, \>8%), and prior therapy for ME in the study eye (yes, no).||The analysis summarized in this section is for the Month 24 time point, comparing the outcome for patients randomized to ranibizumab versus sham injections during the controlled treatment period. The statistical analysis for the Outcome Measure at Month 36 is not shown here. The statistical analysis was not performed at Month 48.||-78.5|-159.6|<0.0001
72553357|NCT00473330|144638176|SUPERIORITY_OR_OTHER||Difference in percentage at Month 24|-3.0||||0.159|TWO_SIDED|95.0|-6.7|0.7||To manage the type I error rate while testing multiple secondary efficacy endpoints for statistical significance, a type I error management plan was implemented. Secondary endpoints were prioritized and tested using a hierarchical testing procedure.|Cochran-Mantel-Haenszel|The analysis was stratified by baseline BCVA score (≤55, \>55 letters), baseline HbA1c (≤8%, \>8%), and prior therapy for ME in the study eye (yes, no).|The percentage for each group and the difference in percentage between groups were estimated using the weighted average of the observed percentages and the differences in observed percentages over the strata using the Cochran-Mantel-Haenszel weights.|The analysis summarized in this section is for the Month 24 time point, comparing the outcome for patients randomized to ranibizumab versus sham injections during the controlled treatment period. The statistical analysis for the Outcome Measure at Month 36 is not shown here.||0.7|-6.7|0.1590
72553816|NCT01415232|144639612|NON_INFERIORITY_OR_EQUIVALENCE|Balki et al found a Pearson's correlation coefficient between the UD and ND depth of 0.85 (95% CI 0.75-0.91). We believe EDE + US would result in a correlation coefficient of approximately 0.91. To keep the lower bound estimate within 0.04 of a correlation of 0.91, and to maintain a 95% confidence level, 140 patients would need to be sampled. To allow for patients who may not complete the study, 160 patients were enrolled.|correlation coefficient|0.91|||<|0.05|TWO_SIDED|95.0|0.87|0.93|||longitudinal correlation coefficient|||Pearson's correlation coefficient was calculated for epidural distance measurements which included actual clinical epidural needle depth (ND) and the epidural depth equation (EDE), ND and prior EDE + US midline longitudinal plane view, ND and prior EDE + US transverse plane view.||0.93|0.87|< 0.05
72553358|NCT00473330|144638176|SUPERIORITY_OR_OTHER||Difference in percentage at Month 24|-2.5||||0.2721|TWO_SIDED|95.0|-6.5|1.4||To manage the type I error rate while testing multiple secondary efficacy endpoints for statistical significance, a type I error management plan was implemented. Secondary endpoints were prioritized and tested using a hierarchical testing procedure.|Cochran-Mantel-Haenszel|The analysis was stratified by baseline BCVA score (≤55, \>55 letters), baseline HbA1c (≤8%, \>8%), and prior therapy for ME in the study eye (yes, no).|The percentage for each group and the difference in percentage between groups were estimated using the weighted average of the observed percentages and the differences in observed percentages over the strata using the Cochran-Mantel-Haenszel weights.|The analysis summarized in this section is for the Month 24 time point, comparing the outcome for patients randomized to ranibizumab versus sham injections during the controlled treatment period. The statistical analysis for the Outcome Measure at Month 36 is not shown here.||1.4|-6.5|0.2721
72553359|NCT00473330|144638177|SUPERIORITY_OR_OTHER||Difference in percentage at Month 24|29.5|||<|0.0001|TWO_SIDED|95.0|21.1|38.0||To manage the type I error rate while testing multiple secondary efficacy endpoints for statistical significance, a type I error management plan was implemented. Secondary endpoints were prioritized and tested using a hierarchical testing procedure.|Cochran-Mantel-Haenszel|The analysis was stratified by baseline BCVA score (≤55, \>55 letters), baseline HbA1c (≤8%, \>8%), and prior therapy for ME in the study eye (yes, no).|The percentage for each group and the difference in percentage between groups were estimated using the weighted average of the observed percentages and the differences in observed percentages over the strata using the Cochran-Mantel-Haenszel weights.|||38.0|21.1|<0.0001
72553360|NCT00473330|144638177|SUPERIORITY_OR_OTHER||Difference in percentage at Month 24|24.2|||<|0.0001|TWO_SIDED|95.0|16.7|31.7||To manage the type I error rate while testing multiple secondary efficacy endpoints for statistical significance, a type I error management plan was implemented. Secondary endpoints were prioritized and tested using a hierarchical testing procedure.|Cochran-Mantel-Haenszel|The analysis was stratified by baseline BCVA score (≤55, \>55 letters), baseline HbA1c (≤8%, \>8%), and prior therapy for ME in the study eye (yes, no).|The percentage for each group and the difference in percentage between groups were estimated using the weighted average of the observed percentages and the differences in observed percentages over the strata using the Cochran-Mantel-Haenszel weights.|||31.7|16.7|<0.0001
72553361|NCT00473330|144638178|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0|||<|0.0001|TWO_SIDED|95.0|-1.4|-0.7||To manage the type I error rate while testing multiple secondary efficacy endpoints for statistical significance, a type I error management plan was implemented. Secondary endpoints were prioritized and tested using a hierarchical testing procedure.|ANOVA|The analysis was stratified by baseline BCVA score (≤55, \>55 letters), baseline HbA1c (≤8%, \>8%), and prior therapy for ME in the study eye (yes, no).||The analysis summarized in this section is for the Month 24 time point, comparing the outcome for patients randomized to ranibizumab versus sham injections during the controlled treatment period. The statistical analysis for the Outcome Measure at Month 36 is not shown here.||-0.7|-1.4|<0.0001
72553362|NCT00473330|144638178|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.1|||<|0.0001|TWO_SIDED|95.0|-1.5|-0.7||To manage the type I error rate while testing multiple secondary efficacy endpoints for statistical significance, a type I error management plan was implemented. Secondary endpoints were prioritized and tested using a hierarchical testing procedure.|ANOVA|The analysis was stratified by baseline BCVA score (≤55, \>55 letters), baseline HbA1c (≤8%, \>8%), and prior therapy for ME in the study eye (yes, no).||The analysis summarized in this section is for the Month 24 time point, comparing the outcome for patients randomized to ranibizumab versus sham injections during the controlled treatment period. The statistical analysis for the Outcome Measure at Month 36 is not shown here.||-0.7|-1.5|<0.0001
72553363|NCT01975948|144638183|OTHER|||||||0.047||||||Adjusted for baseline depressive symptoms and unemployment as covariates (p=.016), and non-completers (missing one or more points of follow up data).|Mixed Models Analysis|||One hundred evaluable patients per arm were needed to achieve 80% power to detect a PHQ-9 between-group difference in mean change of 2 points, significance level (α) .05, a two-sided test, and a standard deviation of 5 points. An intra cluster correlation of 0.05 for patient outcomes was used (Murphey et al), and an average cluster size: 3 patients/practice resulted in compensatory increase to 110 patients per arm. Under the assumption that attrition would be 33 % we needed 166 patients per arm.||||.047
72553364|NCT01975948|144638184|OTHER|||||||0.15|||||||Mixed Models Analysis|||Our calculations indicated that 50 physicians in each of the two groups will provide \>80% power to detect clinically significant reductions in stigma as assessed by OMS-HC change scores. Clinically meaningful was defined as a change of 3 points, derived on the basis of this being slightly better than what is usually seen in brief interventions.||||0.15
72553365|NCT01975948|144638184|OTHER||Cohen'd|0.45||||0.03|TWO_SIDED|||||OMS-HC analysis adjusted for practice size: P value applies to between group physicians reduction in one stigma domaine: preference for social distance|Mixed Models Analysis|||Between Group Changes in subscale of the Opening Minds Scale for Health Care Providers (OMS-HC) measures three different dimensions of stigma: attitudes towards people with a mental illness (6 items); health care professionals' attitudes about disclosure of a mental illness/willingness to seek help for a mental illness (4 items), and preference for social distance (5 items). Items are rated on a 5-point scale. Mean scores can range from one to five with lower scores indicating less stigma.||||.03
72553366|NCT01975948|144638185|OTHER|||||||0.993|||||||Mixed Models Analysis|||||||.993
72553367|NCT01975948|144638186|OTHER||Cohen'd|1.48|||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<.001
72553368|NCT01975948|144638186|OTHER|||||||0.03|||||||Generalized estimating equations (GEE)|We used the slope of a regression line fit using generalized estimating equations (GEE) with an exchangeable correlation structure.||Correlation between increases in Physician Comfort and Confidence in managing mental illness and Stigma Score.||||.03
72553369|NCT01975948|144638187|OTHER||Cohen'd|1.44|||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<.001
72553370|NCT01975948|144638187|SUPERIORITY|||||||0.476||||||We used the slope of a regression line fit using generalized estimating equations (GEE) with an exchangeable correlation structure.|Generalized estimating equations (GEE)|||Correlation between increases in Physician Comfort and Confidence with non-program specific tools and Stigma Score.||||.476
72553371|NCT01975948|144638188|SUPERIORITY||Cohen'd|3.25|||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<.001
72553372|NCT01975948|144638188|SUPERIORITY|||||||0.945||||||We used the Spearman's correlation coefficient using the slope of a regression line fit using generalized estimating equations (GEE) with an exchangeable correlation structure.|Generalized estimating equations (GEE)|||Correlation between increases in Physician Comfort and Confidence with program specific tools and Stigma Score.||||.945
72553373|NCT01975948|144638189|OTHER|||||||0.742|||||||Mixed Models Analysis|||||||.742
72553374|NCT01975948|144638190|OTHER|||||||0.543|||||||Mixed Models Analysis|||||||.543
72553375|NCT01975948|144638191|OTHER|||||||0.009|||||||Mixed Models Analysis|||||||.009
72553376|NCT01975948|144638192|OTHER|||||||0.213|||||||Mixed Models Analysis|||||||.213
72553377|NCT02834663|144638198|SUPERIORITY||Mean Difference (Final Values)|-8.76|STANDARD_DEVIATION|12.521|<|0.0001|TWO_SIDED|95.0|-13.928|-3.592||The threshold for statistical significance was p \< 0.05|t-test, 2 sided|||Patients were evaluated for changes in BCVA of the treated eye, from the start of the study till 6 months, until trial completion. After administration of each injection, measurements of BCVA were compared to their respective baseline results. The paired t-test and repeated measures ANOVA was performed for comparative analysis, as all showed normality.||-3.592|-13.928|<0.0001
72553378|NCT02834663|144638199|SUPERIORITY||Mean Difference (Final Values)|110.0|STANDARD_DEVIATION|65.919||0.0001|TWO_SIDED|95.0|82.79|137.21||The threshold for statistical significance was p \< 0.05|t-test, 2 sided|||||137.210|82.790|0.0001
72553379|NCT02834663|144638200|SUPERIORITY||Mean Difference (Final Values)|3.92|STANDARD_DEVIATION|4.932||0.001|TWO_SIDED|95.0|1.884|5.956||The threshold for statistical significance was p \< 0.05|t-test, 2 sided|||||5.956|1.884|0.001
72553380|NCT02834663|144638201|SUPERIORITY||Mean Difference (Final Values)|2.23|STANDARD_DEVIATION|2.24||0.0001|TWO_SIDED|95.0|1.3|3.15||The threshold for statistical significance was p \< 0.05|t-test, 2 sided|||||3.15|1.30|0.0001
72553381|NCT02834663|144638202|SUPERIORITY||Mean Difference (Final Values)|5.64|STANDARD_DEVIATION|7.21||0.0001|TWO_SIDED|95.0|2.67|8.62||The threshold for statistical significance was p \< 0.05|t-test, 2 sided|||||8.62|2.67|0.0001
72553382|NCT02834663|144638203|SUPERIORITY||Mean Difference (Final Values)|5.64|STANDARD_DEVIATION|7.21||0.0001|TWO_SIDED|95.0|2.67|8.62||The threshold for statistical significance was p \< 0.05|t-test, 2 sided|||||8.62|2.67|0.0001
72368340|NCT03511937|144246671|SUPERIORITY||Mean Difference (Final Values)|-49.5||||0.661|TWO_SIDED|95.0|-271.3|172.3||The a priori threshold for statistical significance was \< 0.05.|Regression, Linear|Analyses controlled for overweight/obese status and Hispanic ethnicity, which were unbalanced between arms, and estimated Huber-White robust SEs.||||172.3|-271.3|0.661
72553383|NCT02834663|144638204|SUPERIORITY||Mean Difference (Final Values)|0.021|STANDARD_DEVIATION|1.87||0.221|TWO_SIDED|95.0|-0.751|0.795||The threshold for statistical significance was p \< 0.05|t-test, 2 sided|||||0.795|-0.751|0.221
72553384|NCT04405570|144638212|SUPERIORITY|||||||0.5551|||||||Log Rank|||||||0.5551
72553385|NCT04405570|144638212|SUPERIORITY|||||||0.727|||||||Log Rank|||||||0.7270
72553386|NCT04405570|144638212|SUPERIORITY|||||||0.0128|||||||Log Rank|||||||0.0128
72553387|NCT04499963|144638216|SUPERIORITY|||||||0.984|||||||t-test, 2 sided|||We compared he ALSFRS-R slope (not the actual score) of the patients in our open label treatment versus the historical controls.||||0.984
72553388|NCT04499963|144638221|OTHER||||||>|0.05|||||||Kruskal-Wallis|||Open Label Arm participant samples from baseline, month 1, and month 6.||||>0.05
72553389|NCT04499963|144638222|OTHER||||||>|0.5||||||Alpha Diversity|Kruskal-Wallis|||Open Label Arm participant samples from baseline, month 1, and month 6.||||>0.5
72553390|NCT04499963|144638223|OTHER||||||>|0.05|||||||Kruskal-Wallis|||Open Label Arm participant samples from baseline, month 1, and month 6.||||>0.05
72553391|NCT04499963|144638224|OTHER||||||>|0.05|||||||Kruskal-Wallis|||Open Label Arm participant samples from baseline, month 1, and month 6.||||>0.05
72553392|NCT04499963|144638225|OTHER||||||>|0.05|||||||Kruskal-Wallis|||Open Label Arm participant samples from baseline, month 1, and month 6.||||>0.05
72553393|NCT04499963|144638226|OTHER||||||>|0.05|||||||Kruskal-Wallis|||Open Label Arm participant samples from baseline, month 1, and month 6.||||>0.05
72553394|NCT04499963|144638227|OTHER||||||>|0.05|||||||Kruskal-Wallis|||Open Label Arm participant samples from baseline, month 1, and month 6.||||>0.05
72553395|NCT04499963|144638228|OTHER||||||>|0.05|||||||Kruskal-Wallis|||Open Label Arm participant samples from baseline, month 1, and month 6.||||>0.05
72553396|NCT03226522|144638245|SUPERIORITY|||||||0.01|||||||Mixed Models Analysis|||||||0.010
72553397|NCT03226522|144638245|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
72553398|NCT00984126|144638246|SUPERIORITY_OR_OTHER||Incidence rate|0.0|||||ONE_SIDED|95.0||1.4||||||A one-sided 95% upper confidence limit was based on an exact calculation for a binomial distribution.||1.4||
72553399|NCT01001208|144638250|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Overall significance level for primary and secondary endpoints controlled based on a combination of sequential testing and Hommel procedures.|Cochran-Mantel-Haenszel|Stratified by baseline body mass index group and prior anti-TNF exposure group||||||<0.0001
72553400|NCT01001208|144638251|SUPERIORITY_OR_OTHER|||||||0.0112||95.0||||Overall significance level for primary and secondary endpoints controlled based on a combination of sequential testing and Hommel procedures.|Cochran-Mantel-Haenszel|Stratified by baseline body mass index group and prior anti-TNF exposure group||||||0.0112
72553401|NCT01001208|144638252|SUPERIORITY_OR_OTHER|||||||0.0112||95.0||||Overall significance level for primary and secondary endpoints controlled based on a combination of sequential testing and Hommel procedures.|Cochran-Mantel-Haenszel|Stratified by baseline body mass index group and prior anti-TNF exposure group||||||0.0112
72553402|NCT01001208|144638253|SUPERIORITY_OR_OTHER|||||||0.0112||95.0||||Overall significance level for primary and secondary endpoints controlled based on a combination of sequential testing and Hommel procedures.|Cochran-Mantel-Haenszel|Stratified by baseline body mass index group and prior anti-TNF exposure group||||||0.0112
72553403|NCT01001208|144638254|SUPERIORITY_OR_OTHER|||||||0.0112||95.0||||Overall significance level for primary and secondary endpoints controlled based on a combination of sequential testing and Hommel procedures.|Cochran-Mantel-Haenszel|Stratified by baseline body mass index group and prior anti-TNF exposure group||||||0.0112
72553404|NCT01001208|144638255|SUPERIORITY_OR_OTHER|||||||0.0112||95.0||||Overall significance level for primary and secondary endpoints controlled based on a combination of sequential testing and Hommel procedures.|Cochran-Mantel-Haenszel|Stratified by baseline body mass index group and prior anti-TNF exposure group||||||0.0112
72553405|NCT01001208|144638256|SUPERIORITY_OR_OTHER|||||||0.0348||95.0||||Overall significance level for primary and secondary endpoints controlled based on a combination of sequential testing and Hommel procedures.|Cochran-Mantel-Haenszel|Stratified by baseline body mass index group and prior anti-TNF exposure group||||||0.0348
72553406|NCT01001208|144638257|SUPERIORITY_OR_OTHER|||||||0.0112||95.0||||Overall significance level for primary and secondary endpoints controlled based on a combination of sequential testing and Hommel procedures.|Cochran-Mantel-Haenszel|Stratified by baseline body mass index group and prior anti-TNF exposure group||||||0.0112
72553407|NCT01001208|144638258|SUPERIORITY_OR_OTHER|||||||0.1995||95.0||||Overall significance level for primary and secondary endpoints controlled based on a combination of sequential testing and Hommel procedures.|2-sided van Elteren test|Stratified by baseline body mass index group and prior anti-TNF exposure group||||||0.1995
72553408|NCT01001208|144638259|SUPERIORITY_OR_OTHER|||||||0.1995||95.0||||Overall significance level for primary and secondary endpoints controlled based on a combination of sequential testing and Hommel procedures.|2-sided van Elteren test|Stratified by baseline body mass index group and prior anti-TNF exposure group||||||0.1995
72553409|NCT01864174|144638260|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The study provided 90% power to demonstrate noninferiority in change from baseline mean HbA1c at Week 24, with an assumed standard deviation (SD) of 1.0%, a non-inferiority margin of 0.3%, and 2-sided alpha of 0.05 for the primary comparison|Mean Difference (Final Values)|0.03|STANDARD_ERROR_OF_MEAN|0.0687|||TWO_SIDED|95.0|-0.1|0.17|||||METFORMIN XR VS METFORMIN IR|||0.17|-0.10|
72553410|NCT01723397|144638267|SUPERIORITY_OR_OTHER|||||||0.8|||||||Wilcoxon signed-rank test|||||||0.8
72553411|NCT02009163|144638290|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||P-value based on a log-rank test, stratified by 4-week cessation status (Yes, No). 4-week cessation was defined as a subject having no binge days during the 4 weeks prior to randomization.|Log Rank|||||||<0.001
72553412|NCT02009163|144638291|SUPERIORITY_OR_OTHER_LEGACY||difference in LS mean|-0.61|||<|0.001|TWO_SIDED|95.0|-0.81|-0.42||Nominal P-value not adjusted for multiplicity.|mixed- effects model for repeated measur|MMRM over all post-randomization visits during the randomized-withdrawal phase. Value for change from baseline = outcome variable.||||-0.42|-0.81|<0.001
72553413|NCT02009163|144638292|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||Unadjusted P-value for the difference in distribution between treatment groups in CGI-S.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test with a modified ridit score, adjusting for Visit 8 (Week 12) CGI-S as the covariate.||||||<0.001
72553414|NCT02009163|144638293|SUPERIORITY_OR_OTHER_LEGACY||difference in LS mean|-5.6|||<|0.001|TWO_SIDED|95.0|-7.2|-3.9||Nominal P-value not adjusted for multiplicity.|mixed-effects model for repeated measure|MMRM over all post-randomization visits during the randomized-withdrawal phase. Value for change from baseline = outcome variable.||||-3.9|-7.2|<0.001
72553415|NCT00833586|144638307|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Test/Ref Ratio of LS Means x 100|95.1||||||90.0|85.8|105.4|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||105.4|85.8|
72553416|NCT00833586|144638308|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Test/Ref Ratio of LS Means x 100|98.9||||||90.0|82.7|118.4|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||118.4|82.7|
72553417|NCT00833586|144638309|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Test/Ref Ratio of LS Means x 100|102.4||||||90.0|95.0|110.5|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||110.5|95.0|
72553418|NCT01085825|144638310|SUPERIORITY_OR_OTHER|||||||0.13|TWO_SIDED||||||Chi-squared|||||||.13
72553419|NCT02444715|144638333|SUPERIORITY_OR_OTHER|||||||0.96|TWO_SIDED||||||t-test, 2 sided|||H0: no change between baseline and post-intervention||||0.96
72553420|NCT02444715|144638333|SUPERIORITY_OR_OTHER|||||||0.03|TWO_SIDED||||||t-test, 2 sided|||H0: no change between baseline and post-intervention||||0.03
72553421|NCT02444715|144638334|SUPERIORITY_OR_OTHER|||||||0.53|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||H0: no change between baseline and post-intervention||||0.53
72553422|NCT02444715|144638334|SUPERIORITY_OR_OTHER|||||||0.44|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||H0: no change between baseline and post-intervention||||0.44
72553423|NCT02444715|144638335|SUPERIORITY_OR_OTHER|||||||0.76|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||H0: no change between baseline and post-intervention||||0.76
72553424|NCT02444715|144638335|SUPERIORITY_OR_OTHER|||||||0.04|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||H0: no change between baseline and post-intervention||||0.04
72553425|NCT02444715|144638336|SUPERIORITY_OR_OTHER|||||||0.39|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||H0: no change between baseline and post-intervention||||0.39
72553426|NCT02444715|144638336|SUPERIORITY_OR_OTHER|||||||0.04|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||H0: no change between baseline and post-intervention||||0.04
72553427|NCT02444715|144638337|SUPERIORITY_OR_OTHER|||||||0.92|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||H0: no change between baseline and post-intervention||||0.92
72553428|NCT02444715|144638337|SUPERIORITY_OR_OTHER|||||||0.37|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||H0: no change between baseline and post-intervention||||0.37
72553429|NCT02444715|144638338|SUPERIORITY_OR_OTHER|||||||0.78|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||H0: no change between baseline and post-intervention||||0.78
72553430|NCT02444715|144638338|SUPERIORITY_OR_OTHER|||||||0.19|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||H0: no change between baseline and post-intervention||||0.19
72553431|NCT02444715|144638339|SUPERIORITY_OR_OTHER|||||||0.9|TWO_SIDED||||||t-test, 2 sided|||H0: no change between baseline and post-intervention||||0.9
72553432|NCT02444715|144638339|SUPERIORITY_OR_OTHER|||||||0.43|TWO_SIDED||||||t-test, 2 sided|||H0: no change between baseline and post-intervention||||0.43
72553433|NCT02444715|144638340|SUPERIORITY_OR_OTHER|||||||0.67|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||H0: no change between baseline and post-intervention||||0.67
72553434|NCT02444715|144638340|SUPERIORITY_OR_OTHER|||||||0.04|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||H0: no change between baseline and post-intervention||||0.04
72553435|NCT02444715|144638341|SUPERIORITY_OR_OTHER|||||||0.26|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||H0: no change between baseline and post-intervention||||0.26
72553436|NCT02444715|144638341|SUPERIORITY_OR_OTHER|||||||0.07|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||H0: no change between baseline and post-intervention||||0.07
72553437|NCT02444715|144638342|SUPERIORITY_OR_OTHER|||||||0.06|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||H0: no change between baseline and post-intervention||||0.06
72553438|NCT02444715|144638342|SUPERIORITY_OR_OTHER|||||||0.04|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||H0: no change between baseline and post-intervention||||0.04
72553439|NCT02444715|144638343|SUPERIORITY_OR_OTHER|||||||0.37|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||"Medium intensity~H0: no change between baseline and post-intervention"||||0.37
72553440|NCT02444715|144638343|SUPERIORITY_OR_OTHER|||||||0.34|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||"Medium intensity~H0: no change between baseline and post-intervention"||||0.34
72553441|NCT02444715|144638343|SUPERIORITY_OR_OTHER|||||||0.37|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||"High intensity~H0: no change between baseline and post-intervention"||||0.37
72553442|NCT02444715|144638343|SUPERIORITY_OR_OTHER|||||||0.59|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||"High intensity~H0: no change between baseline and post-intervention"||||0.59
72553443|NCT02444715|144638344|SUPERIORITY_OR_OTHER|||||||0.64|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||H0: no change between baseline and post-intervention||||0.64
72553444|NCT02444715|144638344|SUPERIORITY_OR_OTHER|||||||0.14|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||H0: no change between baseline and post-intervention||||0.14
72553445|NCT02305758|144638349|SUPERIORITY||Hazard Ratio (HR)|0.939|||||TWO_SIDED|95.0|0.596|1.48||||||Comparisons between treatment groups were performed using the Cox Proportional Hazard Model, stratified by planned bevacizumab use (planned use versus no planned use).||1.480|0.596|
72553446|NCT02305758|144638350|SUPERIORITY||Hazard Ratio (HR)|1.261|||||TWO_SIDED|95.0|0.738|2.156||||||Comparisons between treatment groups were performed using the Cox Proportional Hazard Model, stratified by planned bevacizumab use (planned use versus no planned use).||2.156|0.738|
72553447|NCT02305758|144638351|SUPERIORITY||Difference in proportions|-4.62|||||TWO_SIDED|95.0|-21.4|12.1|||Mantel Haenszel|||Comparisons between treatment groups were performed using the Mantel-Haenszel method, stratified by planned bevacizumab use (planned use versus no planned use).||12.1|-21.4|
72553448|NCT03616106|144638366|OTHER||Slope|-15.103||||0.859|TWO_SIDED|95.0|-184.574|154.369||This p-value is not adjusted for multiple comparisons and the a priori threshold for statistical significance was 0.05.|Regression, Linear|||||154.369|-184.574|0.859
72553449|NCT03616106|144638367|OTHER||Slope|28.243||||0.213|TWO_SIDED|95.0|-16.694|73.179||This p-value is not adjusted for multiple comparisons and the a priori threshold for statistical significance was 0.05.|Regression, Linear|||||73.179|-16.694|0.213
72553450|NCT03616106|144638368|OTHER||Slope|58.993||||0.031|TWO_SIDED|95.0|5.713|112.274||This p-value is not adjusted for multiple comparisons and the a priori threshold for statistical significance was 0.05.|Regression, Linear|||||112.274|5.713|0.031
72553451|NCT03616106|144638369|OTHER||Slope|-0.0651||||0.053|TWO_SIDED|95.0|-1.313|0.01||The p-value was not adjusted for multiple comparisons and the a priori threshold for statistical significance was 0.05.|Regression, Linear|||Viral load variables were log transformed for regression analyses.||0.010|-1.313|0.053
72553452|NCT03616106|144638370|OTHER||Slope|-1.601||||0.008|TWO_SIDED|95.0|-2.761|-0.442||This p-value is not adjusted for multiple comparisons and the a priori threshold for statistical significance was 0.05.|Regression, Linear|||||-0.442|-2.761|0.008
72553453|NCT03616106|144638371|OTHER||Slope|-2.674||||0|TWO_SIDED|95.0|-3.934|-1.415||This p-value is not adjusted for multiple comparisons and the a priori threshold for statistical significance was 0.05.|Regression, Linear|||||-1.415|-3.934|0.000
72553454|NCT03616106|144638385|OTHER||Slope|2.172||||0|TWO_SIDED|95.0|1.448|2.895||This p-value is not adjusted for multiple comparisons and the a priori threshold for statistical significance was 0.05.|Regression, Linear|||||2.895|1.448|0.000
72553455|NCT03616106|144638386|OTHER||Slope|2.872||||0|TWO_SIDED|95.0|2.1|3.643||This p-value is not adjusted for multiple comparisons and the a priori threshold for statistical significance was 0.05.|Regression, Linear|||||3.643|2.100|0.000
72553456|NCT03616106|144638387|OTHER||Slope|3.166||||0|TWO_SIDED|95.0|2.487|3.846||This p-value is not adjusted for multiple comparisons and the a priori threshold for statistical significance was 0.05.|Regression, Linear|||||3.846|2.487|0.000
72553457|NCT03616106|144638388|OTHER||Z Score|3.25||||0.0011|TWO_SIDED|||||The p-value was adjusted for multiple comparisons using the Bonferroni correction. Therefore, the threshold for statistical significance was p≤0.05/3 = .017. Please see statistical analysis plan for further details.|Wilcoxon signed rank|||||||0.0011
72553458|NCT03616106|144638389|OTHER||Z score|3.94||||0.0001|TWO_SIDED|||||The p-value was adjusted for multiple comparisons using the Bonferroni correction. Therefore, the threshold for statistical significance was p≤0.05/3 = .017. Please see statistical analysis plan for further details.|Wilcoxon signed rank|||||||0.0001
72553459|NCT03616106|144638390|OTHER||Z score|4.12||||0|TWO_SIDED|||||The p-value was adjusted for multiple comparisons using the Bonferroni correction. Therefore, the threshold for statistical significance was p≤0.05/3 = .017. Please see statistical analysis plan for further details.|Wilcoxon signed rank|||||||0.000
72553460|NCT03616106|144638391|OTHER||Slope|1.935||||0|TWO_SIDED|95.0|1.055|2.815||This p-value was not adjusted for multiple comparisons. The p-value threshold for statistical significance was, therefore, 0.05|Regression, Linear|||||2.815|1.055|0.000
72553461|NCT03616106|144638392|OTHER||Slope|2.123||||0|TWO_SIDED|95.0|1.184|3.062||The p-value was not adjusted for multiple comparison, therefore, the threshold for statistical significance was 0.05.|Regression, Linear|||||3.062|1.184|0.000
72553462|NCT03616106|144638393|OTHER||Slope|2.552||||0|TWO_SIDED|95.0|1.612|3.492||The p-value was not adjusted for multiple comparison, therefore, the threshold for statistical significance was 0.05.|Regression, Linear|||||3.492|1.612|0.000
72553463|NCT03616106|144638394|OTHER||Z score|-1.57||||0.1167|TWO_SIDED|||||The p-value was adjusted for multiple comparisons using the Bonferroni correction. Therefore, the a priori threshold for statistical significance was p≤0.05/3 = .017. For more details please see the statistical plan.|Wilcoxon signed rank|||||||0.1167
72553464|NCT03616106|144638395|OTHER||Z score|-2.91||||0.0036|TWO_SIDED|||||The p-value was adjusted for multiple comparisons using the Bonferroni correction. Therefore, the a priori threshold for statistical significance was p≤0.05/3 = .017. For more details please see the statistical plan.|Wilcoxon signed rank|||||||0.0036
72553465|NCT03616106|144638396|OTHER||Z score|-3.54||||0.0004|TWO_SIDED|||||The p-value was adjusted for multiple comparisons using the Bonferroni correction. Therefore, the a priori threshold for statistical significance was p≤0.05/3 = .017. For more details please see the statistical plan.|Wilcoxon signed rank|||||||0.0004
72553466|NCT02298322|144638398|OTHER||sucess proportion|91.4|||<|0.0001|TWO_SIDED|95.0|86.2|95.1|||t-test, 1 sided|||||95.1|86.2|<0.0001
72553467|NCT00939003|144638423|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||||||<0.001
72553468|NCT00939003|144638424|SUPERIORITY_OR_OTHER|||||||0.004||95.0|||||Chi-squared|||||||0.004
72553469|NCT00939003|144638425|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||Chi-squared|||||||0.001
72553470|NCT00939003|144638426|SUPERIORITY_OR_OTHER|||||||0.001|||||||ANCOVA|ANCOVA model adjusting for Baseline value with treatment as a factor.||||||0.001
72553471|NCT00939003|144638427|SUPERIORITY_OR_OTHER|||||||0.014||95.0|||||Chi-squared|||||||0.014
72553472|NCT00939003|144638430|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||||||<0.001
72553473|NCT00939003|144638431|SUPERIORITY_OR_OTHER|||||||0.027|||||||ANCOVA|ANCOVA model adjusting for Baseline value with treatment as a factor.||||||0.027
72553474|NCT00939003|144638432|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANCOVA|ANCOVA model adjusting for Baseline value with treatment as a factor.||||||<0.001
72553475|NCT00939003|144638433|SUPERIORITY_OR_OTHER|||||||0.003|||||||ANCOVA|ANCOVA model adjusting for Baseline value with treatment as a factor.||||||0.003
72553476|NCT00939003|144638434|SUPERIORITY_OR_OTHER|||||||0.001|||||||ANCOVA|ANCOVA model adjusting for Baseline value with treatment as a factor.||||||0.001
72553477|NCT03880266|144638452|SUPERIORITY||Mean Difference (Final Values)|-1.58||||0.244|TWO_SIDED|95.0|-3.76|0.6|||Wilcoxon (Mann-Whitney)|||||0.60|-3.76|0.244
72553478|NCT03880266|144638452|SUPERIORITY||Mean Difference (Final Values)|1.39||||0.168|TWO_SIDED|95.0|-0.65|3.43|||Wilcoxon (Mann-Whitney)|||||3.43|-0.65|0.168
72553479|NCT03880266|144638452|SUPERIORITY||Mean Difference (Final Values)|-0.33||||0.699|TWO_SIDED|95.0|-2.39|1.72|||Wilcoxon (Mann-Whitney)|||||1.72|-2.39|0.699
72553480|NCT03880266|144638452|SUPERIORITY||Mean Difference (Final Values)|0.04||||0.833|TWO_SIDED|95.0|-1.94|2.02|||Wilcoxon (Mann-Whitney)|||||2.02|-1.94|0.833
72553481|NCT03880266|144638453|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.000
72553482|NCT03880266|144638453|SUPERIORITY|||||||0.589|||||||Fisher Exact|||||||0.589
72553483|NCT03880266|144638453|SUPERIORITY|||||||0.154|||||||Fisher Exact|||||||0.154
72553484|NCT03880266|144638453|SUPERIORITY|||||||0.646|||||||Fisher Exact|||||||0.646
72553485|NCT03880266|144638454|SUPERIORITY||Mean Difference (Final Values)|-206.5||||0.093|TWO_SIDED|95.0|-451.9|38.9|||t-test, 2 sided|||||38.9|-451.9|0.093
72553486|NCT03880266|144638454|SUPERIORITY||Mean Difference (Final Values)|144.1||||0.186|TWO_SIDED|95.0|-78.6|366.7|||t-test, 2 sided|||||366.7|-78.6|0.186
72553487|NCT03880266|144638454|SUPERIORITY||Mean Difference (Final Values)|-151.7||||0.058|TWO_SIDED|95.0|-309.0|5.7|||t-test, 2 sided|||||5.7|-309.0|0.058
72553488|NCT03880266|144638454|SUPERIORITY||Mean Difference (Final Values)|160.6||||0.186|TWO_SIDED|95.0|-611.2|290.1|||t-test, 2 sided|||||290.1|-611.2|0.186
72553489|NCT03880266|144638455|SUPERIORITY||Mean Difference (Final Values)|-33.62||||0.13|TWO_SIDED|95.0|-78.42|11.17|||t-test, 2 sided|||||11.17|-78.42|0.130
72553490|NCT03880266|144638455|SUPERIORITY||Mean Difference (Final Values)|24.26||||0.518|TWO_SIDED|95.0|-54.62|103.13|||t-test, 2 sided|||||103.13|-54.62|0.518
72553491|NCT03880266|144638455|SUPERIORITY||Mean Difference (Final Values)|-38.14||||0.061|TWO_SIDED|95.0|-78.32|2.03|||t-test, 2 sided|||||2.03|-78.32|0.061
72553492|NCT03880266|144638455|SUPERIORITY||Mean Difference (Final Values)|-39.34||||0.366|TWO_SIDED|95.0|-128.4|49.72|||t-test, 2 sided|||||49.72|-128.40|0.366
72553493|NCT03880266|144638456|SUPERIORITY|||||||0.515|||||||Fisher Exact|||||||0.515
72553494|NCT03880266|144638456|SUPERIORITY|||||||0.56|||||||Fisher Exact|||||||0.560
72553495|NCT03880266|144638456|SUPERIORITY|||||||0.245|||||||Fisher Exact|||||||0.245
72553496|NCT03880266|144638456|SUPERIORITY|||||||0.29|||||||Fisher Exact|||||||0.290
72553497|NCT03161405|144638457|OTHER||Geometric mean ratio|1.9827|||||TWO_SIDED|90.0|1.6446|2.3904||||||A paired t-test on the natural log-transformed parameters was performed. The mean difference and its 90 percent (%) confidence interval (CI) for the log-transformed parameters were exponentiated to obtain the point estimates of the itraconazole effect and 90% CIs.||2.3904|1.6446|
72553498|NCT03161405|144638458|OTHER||Geometric mean ratio|1.2914|||||TWO_SIDED|90.0|1.1199|1.4891||||||A paired t-test on the natural log-transformed parameters was performed. The mean difference and its 90% CI for the log-transformed parameters were exponentiated to obtain the point estimates of the itraconazole effect and 90% CIs.||1.4891|1.1199|
72553499|NCT03161405|144638459|OTHER||Geometric mean ratio|1.2783|||||TWO_SIDED|90.0|1.0965|1.4904||||||A paired t-test on the natural log-transformed parameters was performed. The mean difference and its 90% CI for the log-transformed parameters were exponentiated to obtain the point estimates of the itraconazole effect and 90% CIs.||1.4904|1.0965|
72553500|NCT00837486|144638460|SUPERIORITY_OR_OTHER||||||=|0.53||||||"one-sided P-value~per protocol responder rates: Active Group = 20.0%, Control Group = 14.3%"|Fisher Exact|||The study originally required a sample size of 208 subjects in order to have 90% power to detect a statistically significant difference between the responder rate of the active and control groups. With this 30-subject cohort, and only 29 subjects completing the blinded-treatment phase per protocol, the comparison of response rates was not adequately powered. The P-value is presented only to describe the outcomes of the two groups.||||=0.53
72553501|NCT03235739|144638471|SUPERIORITY|multiple imputation for longitudinal data was conducted to impute the missing data for the primary outcome. The final results were obtained from pooling results from 10 imputed complete case data set.|geometric mean ratio|0.9||||0.84|TWO_SIDED|95.0|0.32|2.55|||Mixed Models Analysis|||||2.55|0.32|0.84
72553502|NCT03235739|144638471|SUPERIORITY|A sensitivity analysis using complete case analysis|geometric mean ratio|0.82||||0.73|TWO_SIDED|95.0|0.26|2.56|||Mixed Models Analysis|||||2.56|0.26|0.73
72553503|NCT03235739|144638472|SUPERIORITY||geometric mean ratio|1.02||||0.91|TWO_SIDED|98.3|0.63|1.67|||Mixed Models Analysis|||||1.67|0.63|0.91
72553504|NCT03235739|144638473|SUPERIORITY||Risk Ratio (RR)|2.58||||0.012|TWO_SIDED|98.3|0.98|6.8|||Chi-squared|||||6.80|0.98|0.012
72553505|NCT03235739|144638474|SUPERIORITY||median of differences|-5.0||||0.08|TWO_SIDED|98.3|-12.0|2.0|||Wilcoxon (Mann-Whitney)|||||2|-12|0.08
72553506|NCT02847650|144638475|OTHER||Least Squares Mean Difference|-4.8|STANDARD_ERROR_OF_MEAN|2.26||0.0407|TWO_SIDED|90.0|-8.6|-1.0|||Mixed Models Analysis|||||-1.0|-8.6|0.0407
72553507|NCT03818581|144638487|SUPERIORITY|||||||0.15|||||||SPCD analysis|||||||0.15
72553508|NCT00834249|144638495|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|101.73||||||90.0|||||||Bioequivalence is established when ratio of means falls within 80-125.|||||
72553509|NCT00834249|144638496|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|99.73||||||90.0|||||||Bioequivalence is established when ratio of means falls within 80-125.|||||
72553510|NCT00834249|144638497|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|99.71||||||90.0|||||||Bioequivalence is established when ratio of means falls within 80-125.|||||
72553511|NCT00834249|144638498|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|109.61||||||90.0|||||||Metabolite results not subjected to bioequivalence criteria, results are presented for informational purposes only.|||||
72553512|NCT00834249|144638499|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|106.85||||||90.0|||||||Metabolite results not subjected to bioequivalence criteria, results are presented for informational puposes only.|||||
72553513|NCT00834249|144638500|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|106.38||||||90.0|||||||Metabolite results not subjected to bioequivalence criteria, results are presented for informational purposes only.|||||
72553514|NCT02718326|144638503|SUPERIORITY||percentage difference|52.3|||<|0.0001|TWO_SIDED|95.0|45.2|59.5|||Cochran-Mantel-Haenszel|||||59.5|45.2|<0.0001
72553515|NCT02718326|144638504|SUPERIORITY||percentage difference|50.1|||<|0.0001|TWO_SIDED|95.0|40.1|60.1|||Cochran-Mantel-Haenszel|||||60.1|40.1|<0.0001
72553516|NCT02718326|144638504|SUPERIORITY||percentage difference|64.8|||<|0.0001|TWO_SIDED|95.0|55.8|73.9|||Cochran-Mantel-Haenszel|||||73.9|55.8|< 0.0001
72553517|NCT02718326|144638505|SUPERIORITY||percentage difference|-17.3|||<|0.0001|TWO_SIDED|95.0|-24.7|-9.9|||Cochran-Mantel-Haenszel|||||-9.9|-24.7|<0.0001
72553518|NCT02718326|144638505|SUPERIORITY||percentage difference|-16.6|||<|0.0001|TWO_SIDED|95.0|-24.2|-9.1|||Cochran-Mantel-Haenszel|||||-9.1|-24.2|<0.0001
72553519|NCT02718326|144638506|SUPERIORITY||percentage difference|-17.3|||=|0.0002|TWO_SIDED|95.0|-26.2|-8.5|||Cochran-Mantel-Haenszel|||||-8.5|-26.2|= 0.0002
72553520|NCT02718326|144638506|SUPERIORITY||percentage difference|-18.9|||<|0.0001|TWO_SIDED|95.0|-27.5|-10.4|||Cochran-Mantel-Haenszel|||||-10.4|-27.5|<0.0001
72553521|NCT02718326|144638509|SUPERIORITY||percentage difference|-6.0||||0.0096|TWO_SIDED|95.0|-10.5|-1.5|||Cochran-Mantel-Haenszel|||||-1.5|-10.5|0.0096
72553522|NCT02718326|144638509|SUPERIORITY||percentage difference|-6.0||||0.0089|TWO_SIDED|95.0|-10.5|-1.6|||Cochran-Mantel-Haenszel|||||-1.6|-10.5|0.0089
72553523|NCT02718326|144638510|SUPERIORITY||Estimate for contrast|0.8||||0.0529|TWO_SIDED|95.0|-0.01|1.6|||ANOVA|||||1.60|-0.01|0.0529
72553524|NCT02718326|144638510|SUPERIORITY||Estimate for contrast|1.14||||0.0057|TWO_SIDED|95.0|0.33|1.94|||ANOVA|||||1.94|0.33|0.0057
72553525|NCT05025345|144638513|NON_INFERIORITY|Noninferiority margin equals -0.1|Mean Difference (Final Values)|-0.013|||||TWO_SIDED|90.0|-0.036|0.011||Success criteria was evaluated using lower confidence interval. No P-Value was calculated.||||||0.011|-0.036|
72553526|NCT05025345|144638514|SUPERIORITY||||||<|0.0001|||||||t-test, 1 sided|||||||<0.0001
72553527|NCT02322593|144638532|SUPERIORITY||Hazard Ratio (HR)|0.83|STANDARD_ERROR_OF_MEAN|0.091||0.039|TWO_SIDED|95.0|0.69|0.99|||Log Rank|||||0.99|0.69|0.039
72553528|NCT02322593|144638533|SUPERIORITY||Hazard Ratio (HR)|0.79|STANDARD_ERROR_OF_MEAN|0.086||0.0045|TWO_SIDED|95.0|0.66|0.93|||Log Rank|||||0.93|0.66|0.0045
72553529|NCT02322593|144638534|SUPERIORITY||Hazard Ratio (HR)|0.82|STANDARD_ERROR_OF_MEAN|0.078||0.011|TWO_SIDED|95.0|0.7|0.96|||Log Rank|||||0.96|0.70|0.011
72553530|NCT02322593|144638535|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||<0.001
72553531|NCT02322593|144638536|SUPERIORITY|||||||0.092|||||||Fisher Exact|||||||0.092
72553532|NCT00834418|144638537|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-72 and Cmax.|Geometric Test/Ref Ratio x 100|107.0||||||90.0|99.6|116.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||116|99.6|
72553533|NCT00834418|144638538|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-72 and Cmax.|Geometric Test/Ref Ratio x 100|102.0||||||90.0|95.2|109.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||109|95.2|
72553534|NCT01299454|144638560|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was claimed for a PK parameter if the 90% CI for the ratio of the geometric means of a PK variable fell within the interval \[0.5, 2.0\]. Due to the nature of the normal-theory CIs, this approach was equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|Geometric Mean Ratio|1.166|||||TWO_SIDED|90.0|0.776|1.751|||Mixed effect analysis of variance||Due to the nature of the normal-theory CIs, this approach is equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|The primary comparison was each hepatic disease group (mild, moderate or severe) versus the control (normal group). To compare the primary PK parameters between each hepatic disease group and the control group, the 90% confidence interval (CI) for the difference in the means of the log-transformed data was calculated using a mixed effect analysis of variance.||1.751|0.776|
72553817|NCT01415232|144639612|NON_INFERIORITY_OR_EQUIVALENCE|correlation coefficient|transverse plane correlation coefficient|0.9|||>|0.85|TWO_SIDED|95.0|0.87|0.93|||transverse plane correlation coefficient|||Transverse plane correlation coefficient||0.93|0.87|>0.85
72553818|NCT01415232|144639612|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.64|STANDARD_DEVIATION|1.0|>|0.05|TWO_SIDED|95.0|6.5|6.8|||t-test, 2 sided|||Clinical epidural needle depth||6.8|6.5|>0.05
72553819|NCT01415232|144639612|SUPERIORITY_OR_OTHER||Formula calculation|6.54|STANDARD_DEVIATION|0.68|>|0.05|TWO_SIDED|95.0|6.44|6.65|||Formula calculation||Estimated epidural depth equation depth (cm)|Estimated epidural depth equation depth (cm)||6.65|6.44|>0.05
72553535|NCT01299454|144638560|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was claimed for a PK parameter if the 90% CI for the ratio of the geometric means of a PK variable fell within the interval \[0.5, 2.0\]. Due to the nature of the normal-theory CIs, this approach was equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|Geometric Mean Ratio|1.375|||||TWO_SIDED|90.0|0.915|2.066|||Mixed effect analysis of variance||Due to the nature of the normal-theory CIs, this approach is equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|The primary comparison was each hepatic disease group (mild, moderate or severe) versus the control (normal group). To compare the primary PK parameters between each hepatic disease group and the control group, the 90% CI for the difference in the means of the log-transformed data was calculated using a mixed effect analysis of variance.||2.066|0.915|
72553536|NCT01299454|144638560|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was claimed for a PK parameter if the 90% CI for the ratio of the geometric means of a PK variable fell within the interval \[0.5, 2.0\]. Due to the nature of the normal-theory CIs, this approach was equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|Geometric Mean Ratio|0.929|||||TWO_SIDED|90.0|0.581|1.488|||Mixed effect analysis of variance||Due to the nature of the normal-theory CIs, this approach is equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|The primary comparison was each hepatic disease group (mild, moderate or severe) versus the control (normal group). To compare the primary PK parameters between each hepatic disease group and the control group, the 90% CI for the difference in the means of the log-transformed data was calculated using a mixed effect analysis of variance.||1.488|0.581|
72553537|NCT01299454|144638561|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was claimed for a PK parameter if the 90% CI for the ratio of the geometric means of a PK variable fell within the interval \[0.5, 2.0\]. Due to the nature of the normal-theory CIs, this approach was equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|Geometic Mean Ratio|1.255|||||TWO_SIDED|90.0|0.702|2.244|||Mixed effect analysis of variance||Due to the nature of the normal-theory CIs, this approach is equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|The primary comparison was each hepatic disease group (mild, moderate or severe) versus the control (normal group). To compare the primary PK parameters between each hepatic disease group and the control group, the 90% confidence interval (CI) for the difference in the means of the log-transformed data was calculated using a mixed effect analysis of variance.||2.244|0.702|
72553538|NCT01299454|144638561|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was claimed for a PK parameter if the 90% CI for the ratio of the geometric means of a PK variable fell within the interval \[0.5, 2.0\]. Due to the nature of the normal-theory CIs, this approach was equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|Geometric Mean Ratio|1.727|||||TWO_SIDED|90.0|0.977|3.052|||Mixed effect analysis of variance||Due to the nature of the normal-theory CIs, this approach is equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|The primary comparison was each hepatic disease group (mild, moderate or severe) versus the control (normal group). To compare the primary PK parameters between each hepatic disease group and the control group, the 90% CI for the difference in the means of the log-transformed data was calculated using a mixed effect analysis of variance.||3.052|0.977|
72553539|NCT01299454|144638561|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was claimed for a PK parameter if the 90% CI for the ratio of the geometric means of a PK variable fell within the interval \[0.5, 2.0\]. Due to the nature of the normal-theory CIs, this approach was equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|Geometic Mean Ratio|1.041|||||TWO_SIDED|90.0|0.506|2.142|||Mixed effect analysis of variance||Due to the nature of the normal-theory CIs, this approach is equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|The primary comparison was each hepatic disease group (mild, moderate or severe) versus the control (normal group). To compare the primary PK parameters between each hepatic disease group and the control group, the 90% CI for the difference in the means of the log-transformed data was calculated using a mixed effect analysis of variance||2.142|0.506|
72553540|NCT01299454|144638562|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was claimed for a PK parameter if the 90% CI for the ratio of the geometric means of a PK variable fell within the interval \[0.5, 2.0\]. Due to the nature of the normal-theory CIs, this approach was equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|Geometric Mean Ratio|0.904|||||TWO_SIDED|90.0|0.707|1.156|||Mixed effect analysis of variance||Due to the nature of the normal-theory CIs, this approach is equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|The primary comparison was each hepatic disease group (mild, moderate or severe) versus the control (normal group). To compare the primary PK parameters between each hepatic disease group and the control group, the 90% CI for the difference in the means of the log-transformed data was calculated using a mixed effect analysis of variance||1.156|0.707|
72553541|NCT01299454|144638562|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was claimed for a PK parameter if the 90% CI for the ratio of the geometric means of a PK variable fell within the interval \[0.5, 2.0\]. Due to the nature of the normal-theory CIs, this approach was equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|Geometric Mean Ratio|0.85|||||TWO_SIDED|90.0|0.665|1.087|||Mixed effect analysis of variance||Due to the nature of the normal-theory CIs, this approach is equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|The primary comparison was each hepatic disease group (mild, moderate or severe) versus the control (normal group). To compare the primary PK parameters between each hepatic disease group and the control group, the 90% CI for the difference in the means of the log-transformed data was calculated using a mixed effect analysis of variance||1.087|0.665|
72553856|NCT02440711|144639731|SUPERIORITY|||||||0.4||||||Holm-Bonferroni adjustments for multiple comparisons were applied to yield an experiment-wise alpha level of .05.|t-test, 2 sided|||Sound side step time results||||.40
72368341|NCT03511937|144246672|SUPERIORITY||Mean Difference (Final Values)|12.5||||0.082|TWO_SIDED|95.0|-1.6|26.6||The a priori threshold for statistical significance was \< 0.05.|Two-part regression model with robust SE|Analyses controlled for overweight/obese status and Hispanic ethnicity, which were unbalanced between arms, and estimated Huber-White robust SEs.||||26.6|-1.6|0.082
72368342|NCT02284243|144246674|SUPERIORITY_OR_OTHER|||||||0.018|||||||ANCOVA|||||||0.0180
72368343|NCT02284243|144246675|SUPERIORITY_OR_OTHER||||||<|0.05||||||Applies to SPID 0-6, SPID 0-12, and SPID 0-24|ANCOVA|||||||<0.05
72368344|NCT02284243|144246676|SUPERIORITY_OR_OTHER||||||<|0.05||||||Applies to perceptible and meaningful pain relief|Log Rank|||||||<0.05
72553542|NCT01299454|144638562|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was claimed for a PK parameter if the 90% CI for the ratio of the geometric means of a PK variable fell within the interval \[0.5, 2.0\]. Due to the nature of the normal-theory CIs, this approach was equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|Geometric Mean Ratio|0.531||||||90.0|0.399|0.705|||Mixed effect analysis of variance||Due to the nature of the normal-theory CIs, this approach is equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|The primary comparison was each hepatic disease group (mild, moderate or severe) versus the control (normal group). To compare the primary PK parameters between each hepatic disease group and the control group, the 90% confidence interval (CI) for the difference in the means of the log-transformed data was calculated using a mixed effect analysis of variance||0.705|0.399|
72553543|NCT01299454|144638563|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was claimed for a PK parameter if the 90% CI for the ratio of the geometric means of a PK variable fell within the interval \[0.5, 2.0\]. Due to the nature of the normal-theory CIs, this approach was equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|Geometric Mean Ratio|1.103|||||TWO_SIDED|90.0|0.774|1.573|||Mixed effect analysis of variance||Due to the nature of the normal-theory CIs, this approach is equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|The secondary comparisons were each hepatic disease group (mild, moderate or severe) versus the control (normal group). To compare the secondary PK parameters between each hepatic disease group and the control group, the 90% CI for the difference in the means of the log-transformed data was calculated using a mixed effect analysis of variance.||1.573|0.774|
72553544|NCT01299454|144638563|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was claimed for a PK parameter if the 90% CI for the ratio of the geometric means of a PK variable fell within the interval \[0.5, 2.0\]. Due to the nature of the normal-theory CIs, this approach was equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|Geometric Mean Ratio|1.199|||||TWO_SIDED|90.0|0.841|1.71|||Mixed effect analysis of variance||Due to the nature of the normal-theory CIs, this approach is equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|The secondary comparisons were each hepatic disease group (mild, moderate or severe) versus the control (normal group). To compare the secondary PK parameters between each hepatic disease group and the control group, the 90% CI for the difference in the means of the log-transformed data was calculated using a mixed effect analysis of variance.||1.710|0.841|
72553545|NCT01299454|144638563|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was claimed for a PK parameter if the 90% CI for the ratio of the geometric means of a PK variable fell within the interval \[0.5, 2.0\]. Due to the nature of the normal-theory CIs, this approach was equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|Geometric Mean Ratio|0.79|||||TWO_SIDED|90.0|0.524|1.189|||Mixed effect analysis of variance||Due to the nature of the normal-theory CIs, this approach is equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|The secondary comparisons were each hepatic disease group (mild, moderate or severe) versus the control (normal group). To compare the secondary PK parameters between each hepatic disease group and the control group, the 90% CI for the difference in the means of the log-transformed data was calculated using a mixed effect analysis of variance.||1.189|0.524|
72553546|NCT01299454|144638564|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was claimed for a PK parameter if the 90% CI for the ratio of the geometric means of a PK variable fell within the interval \[0.5, 2.0\]. Due to the nature of the normal-theory CIs, this approach was equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|Geometric Mean Ratio|1.241|||||TWO_SIDED|90.0|0.719|2.143|||Mixed effect analysis of variance||Due to the nature of the normal-theory CIs, this approach is equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|The secondary comparisons were each hepatic disease group (mild, moderate or severe) versus the control (normal group). To compare the secondary PK parameters between each hepatic disease group and the control group, the 90% CI for the difference in the means of the log-transformed data was calculated using a mixed effect analysis of variance.||2.143|0.719|
72553547|NCT01299454|144638564|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was claimed for a PK parameter if the 90% CI for the ratio of the geometric means of a PK variable fell within the interval \[0.5, 2.0\]. Due to the nature of the normal-theory CIs, this approach was equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance|Geometric Mean Ratio|1.604|||||TWO_SIDED|90.0|0.942|2.732|||Mixed effect analysis of variance||Due to the nature of the normal-theory CIs, this approach is equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|The secondary comparisons were each hepatic disease group (mild, moderate or severe) versus the control (normal group). To compare the secondary PK parameters between each hepatic disease group and the control group, the 90% CI for the difference in the means of the log-transformed data was calculated using a mixed effect analysis of variance.||2.732|0.942|
72553548|NCT01299454|144638564|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was claimed for a PK parameter if the 90% CI for the ratio of the geometric means of a PK variable fell within the interval \[0.5, 2.0\]. Due to the nature of the normal-theory CIs, this approach was equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|Geometric Mean Ratio|1.077|||||TWO_SIDED|90.0|0.54|2.146|||Mixed effect analysis of variance||Due to the nature of the normal-theory CIs, this approach is equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|The secondary comparisons were each hepatic disease group (mild, moderate or severe) versus the control (normal group). To compare the secondary PK parameters between each hepatic disease group and the control group, the 90% CI for the difference in the means of the log-transformed data was calculated using a mixed effect analysis of variance.||2.146|0.540|
72553857|NCT02440711|144639733|SUPERIORITY|||||||0.14||||||Holm-Bonferroni adjustments for multiple comparisons were applied to yield an experiment-wise alpha level of .05.|t-test, 2 sided|||||||.14
72553858|NCT02440711|144639735|SUPERIORITY|||||||0.001||||||Holm-Bonferroni adjustments for multiple comparisons were applied to yield an experiment-wise alpha level of .05.|t-test, 2 sided|||||||0.001
72553859|NCT02440711|144639737|SUPERIORITY|||||||0.001||||||Holm-Bonferroni adjustments for multiple comparisons were applied to yield an experiment-wise alpha level of .05.|t-test, 2 sided|||||||0.001
72368345|NCT02284243|144246677|SUPERIORITY_OR_OTHER||||||<|0.05||||||Applies to ≥30% and ≥50% reduction in pain|Cochran-Mantel-Haenszel|Test for general association stratified by site||||||<0.05
72368346|NCT02284243|144246679|SUPERIORITY_OR_OTHER|||||||0.0009|||||||Log Rank|||||||0.0009
72553549|NCT01299454|144638565|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was claimed for a PK parameter if the 90% CI for the ratio of the geometric means of a PK variable fell within the interval \[0.5, 2.0\]. Due to the nature of the normal-theory CIs, this approach was equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|Geometric mean ratio|0.856|||||TWO_SIDED|90.0|0.691|1.059|||Mixed effect analysis of variance||Due to the nature of the normal-theory CIs, this approach is equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|The secondary comparisons were each hepatic disease group (mild, moderate or severe) versus the control (normal group). To compare the secondary PK parameters between each hepatic disease group and the control group, the 90% CI for the difference in the means of the log-transformed data was calculated using a mixed effect analysis of variance.||1.059|0.691|
72553550|NCT01299454|144638565|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was claimed for a PK parameter if the 90% CI for the ratio of the geometric means of a PK variable fell within the interval \[0.5, 2.0\]. Due to the nature of the normal-theory CIs, this approach was equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|Geometric Mean Ratio|0.742|||||TWO_SIDED|90.0|0.599|0.918|||Mixed effect analysis of variance||Due to the nature of the normal-theory CIs, this approach is equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|The secondary comparisons were each hepatic disease group (mild, moderate or severe) versus the control (normal group). To compare the secondary PK parameters between each hepatic disease group and the control group, the 90% CI for the difference in the means of the log-transformed data was calculated using a mixed effect analysis of variance.||0.918|0.599|
72553551|NCT01299454|144638565|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was claimed for a PK parameter if the 90% CI for the ratio of the geometric means of a PK variable fell within the interval \[0.5, 2.0\]. Due to the nature of the normal-theory CIs, this approach was equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|Geometric Mean Ratio|0.451|||||TWO_SIDED|90.0|0.352|0.577|||Mixed effect analysis of variance||Due to the nature of the normal-theory CIs, this approach is equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|The secondary comparisons were each hepatic disease group (mild, moderate or severe) versus the control (normal group). To compare the secondary PK parameters between each hepatic disease group and the control group, the 90% CI for the difference in the means of the log-transformed data was calculated using a mixed effect analysis of variance.||0.577|0.352|
72553552|NCT01299454|144638574|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was claimed for a PK parameter if the 90% CI for the ratio of the geometric means of a PK variable fell within the interval \[0.5, 2.0\]. Due to the nature of the normal-theory CIs, this approach was equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|Geometric Mean Ratio|0.509|||||TWO_SIDED|90.0|0.346|0.748|||Mixed effect analysis of variance|||The secondary comparisons were each hepatic disease group (mild, moderate or severe) versus the control (normal group). To compare the secondary PK parameters between each hepatic disease group and the control group, the 90% CI for the difference in the means of the log-transformed data was calculated using a mixed effect analysis of variance.||0.748|0.346|
72553553|NCT01299454|144638574|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was claimed for a PK parameter if the 90% CI for the ratio of the geometric means of a PK variable fell within the interval \[0.5, 2.0\]. Due to the nature of the normal-theory CIs, this approach was equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|Geometric Mean Ratio|0.586|||||TWO_SIDED|90.0|0.399|0.861|||Mixed effect analysis of variance||Due to the nature of the normal-theory CIs, this approach is equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|The secondary comparisons were each hepatic disease group (mild, moderate or severe) versus the control (normal group). To compare the secondary PK parameters between each hepatic disease group and the control group, the 90% CI for the difference in the means of the log-transformed data was calculated using a mixed effect analysis of variance.||0.861|0.399|
72553554|NCT01299454|144638574|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was claimed for a PK parameter if the 90% CI for the ratio of the geometric means of a PK variable fell within the interval \[0.5, 2.0\]. Due to the nature of the normal-theory CIs, this approach was equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|Geometric Mean Ratio|0.334|||||TWO_SIDED|90.0|0.214|0.521|||Mixed effect analysis of variance||Due to the nature of the normal-theory CIs, this approach is equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|The secondary comparisons were each hepatic disease group (mild, moderate or severe) versus the control (normal group). To compare the secondary PK parameters between each hepatic disease group and the control group, the 90% CI for the difference in the means of the log-transformed data was calculated using a mixed effect analysis of variance.||0.521|0.214|
72553555|NCT01299454|144638575|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was claimed for a PK parameter if the 90% CI for the ratio of the geometric means of a PK variable fell within the interval \[0.5, 2.0\]. Due to the nature of the normal-theory CIs, this approach was equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|Geometric Mean Ratio|0.716|||||TWO_SIDED|90.0|0.445|1.153|||Mixed effect analysis of variance|||The secondary comparisons were each hepatic disease group (mild, moderate or severe) versus the control (normal group). To compare the secondary PK parameters between each hepatic disease group and the control group, the 90% CI for the difference in the means of the log-transformed data was calculated using a mixed effect analysis of variance.||1.153|0.445|
72553556|NCT01299454|144638575|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was claimed for a PK parameter if the 90% CI for the ratio of the geometric means of a PK variable fell within the interval \[0.5, 2.0\]. Due to the nature of the normal-theory CIs, this approach was equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|Geometric Mean Ratio|0.594|||||TWO_SIDED|90.0|0.378|0.934|||Mixed effect analysis of variance|||The secondary comparisons were each hepatic disease group (mild, moderate or severe) versus the control (normal group). To compare the secondary PK parameters between each hepatic disease group and the control group, the 90% CI for the difference in the means of the log-transformed data was calculated using a mixed effect analysis of variance.||0.934|0.378|
72553860|NCT02440711|144639739|SUPERIORITY|||||||0.005||||||Holm-Bonferroni adjustments for multiple comparisons were applied to yield an experiment-wise alpha level of .05.|t-test, 2 sided|||||||0.005
72368347|NCT02284243|144246680|SUPERIORITY_OR_OTHER|||||||0.7718|||||||Cochran-Mantel-Haenszel|||||||0.7718
72553557|NCT01299454|144638575|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was claimed for a PK parameter if the 90% CI for the ratio of the geometric means of a PK variable fell within the interval \[0.5, 2.0\]. Due to the nature of the normal-theory CIs, this approach was equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|Geometric Mean Ratio|0.561|||||TWO_SIDED|90.0|0.308|1.022|||Mixed effect analysis of variance|||The secondary comparisons were each hepatic disease group (mild, moderate or severe) versus the control (normal group). To compare the secondary PK parameters between each hepatic disease group and the control group, the 90% CI for the difference in the means of the log-transformed data was calculated using a mixed effect analysis of variance.||1.022|0.308|
72553558|NCT01299454|144638576|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was claimed for a PK parameter if the 90% CI for the ratio of the geometric means of a PK variable fell within the interval \[0.5, 2.0\]. Due to the nature of the normal-theory CIs, this approach was equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|Geometric Mean Ratio|0.558|||||TWO_SIDED|90.0|0.368|0.845|||Mixed effect analysis of variance|||The secondary comparisons were each hepatic disease group (mild, moderate or severe) versus the control (normal group). To compare the secondary PK parameters between each hepatic disease group and the control group, the 90% CI for the difference in the means of the log-transformed data was calculated using a mixed effect analysis of variance.||0.845|0.368|
72553559|NCT01299454|144638576|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was claimed for a PK parameter if the 90% CI for the ratio of the geometric means of a PK variable fell within the interval \[0.5, 2.0\]. Due to the nature of the normal-theory CIs, this approach was equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|Geometric Mean Ratio|0.516|||||TWO_SIDED|90.0|0.341|0.781|||Mixed effect analysis of variance|||The secondary comparisons were each hepatic disease group (mild, moderate or severe) versus the control (normal group). To compare the secondary PK parameters between each hepatic disease group and the control group, the 90% CI for the difference in the means of the log-transformed data was calculated using a mixed effect analysis of variance.||0.781|0.341|
72553560|NCT01299454|144638576|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was claimed for a PK parameter if the 90% CI for the ratio of the geometric means of a PK variable fell within the interval \[0.5, 2.0\]. Due to the nature of the normal-theory CIs, this approach was equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|Geometric Mean Ratio|0.314|||||TWO_SIDED|90.0|0.195|0.507|||Mixed effect analysis of variance|||The secondary comparisons were each hepatic disease group (mild, moderate or severe) versus the control (normal group). To compare the secondary PK parameters between each hepatic disease group and the control group, the 90% CI for the difference in the means of the log-transformed data was calculated using a mixed effect analysis of variance.||0.507|0.195|
72553561|NCT03965091|144638588|OTHER||Least square (LS) mean difference|0.1|STANDARD_ERROR_OF_MEAN|0.27||0.7963|TWO_SIDED|95.0|-0.46|0.6|||Mixed Models Analysis|||Analysis was performed using a Mixed Model Repeated Measures (MMRM) model with change from baseline in the weekly average of the daily average PI-NRS score over the past 24 hours at weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12 as the dependent variable, sex, age group at FM onset, week, treatment, and treatment-by-week interaction as fixed factors, and baseline average of the daily average PI-NRS score as a covariate.||0.60|-0.46|0.7963
72553562|NCT03965091|144638588|OTHER||LS mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.27||0.8629|TWO_SIDED|95.0|-0.48|0.58|||Mixed Models Analysis|||Analysis was performed using an MMRM model with change from baseline in the weekly average of the daily average PI-NRS score over the past 24 hours at weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12 as the dependent variable, sex, age group at FM onset, week, treatment, and treatment-by-week interaction as fixed factors, and baseline average of the daily average PI-NRS score as a covariate.||0.58|-0.48|0.8629
72553563|NCT02576938|144638610|SUPERIORITY||||||=|0.065|||||||Chi-squared|||||||=0.065
72553564|NCT02576938|144638610|SUPERIORITY||||||=|0.027|||||||Chi-squared|||||||=0.027
72553565|NCT00982397|144638622|SUPERIORITY_OR_OTHER||percentage of participants|98.5|||||TWO_SIDED|95.0|97.9|99.0|||||Therapy rates were analyzed using competing risks survival analysis methods, accounting for death as a competing risk.Therapy incidence rates were estimated using cumulative incidence functions and reported with 95% confidence interval.|The study was designed to include at least 1,131 patients with DR/CRT-D ICD devices in order to estimate the inappropriate shock free rate at 1 year post-implant with 1% precision.||99.0|97.9|
72368348|NCT00541385|144246701|OTHER|"Analysis of the PCR-corrected ACPR response rate on Day 28 for the PA group. Null hypothesis: The PCR-corrected ACPR response rate on Day 28 for the PA group is ≤90%.~Was tested versus the alternative:~Alternative hypothesis: The PCR-corrected ACPR response rate on Day 28 for the PA group is \>90%."|||||<|0.0001||||||The threshold for significance was ≤0.025.|Exact binomial test|||||||<0.0001
72553566|NCT00982397|144638622|SUPERIORITY_OR_OTHER||percentage of participants|97.5|||||TWO_SIDED|95.0|96.1|98.5|||||Therapy rates were analyzed using competing risks survival analysis methods, accounting for death as a competing risk.Therapy incidence rates were estimated using cumulative incidence functions and reported with 95% confidence interval.|This study was designed to include at least 610 patients with VR-ICD devices in order to estimate the inappropriate shock free rate at 1 year post-implant with a precision of 2%.||98.5|96.1|
72553567|NCT00982397|144638623|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value is for comparison against a performance criterion of 10%.|Exact Binomial|||Using the one-sided one proportion Exact Test in PASS sample size software, a sample size of 76 subjects with 1-month follow-up was calculated to be required for the evaluation of this objective. To ensure adequate testing of the Protecta XT CRT-D device, the 76 subjects must have included at least 34 CRT-D subjects. Assuming an attrition rate of 10%, a sample size of 85 subjects enrolled was calculated to be required.||||<0.0001
72553568|NCT00982397|144638624|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value is for comparison of the observed proportion of successes against a protocol-specified performance criterion of 95%.|Confidence interval and hypothesis test|||P, the expected proportion of successes under the null hypothesis, was 95%. α, the Type I error rate, is 0.025. Power is 90%. Pa, the assumed true proportion of successes, is 99%. Based on the above assumptions, at least 173 subjects with a useable time to VF detection testing were required for this objective. Assuming a 5% rate for the potential non-adherence to the testing protocol, the required enrollment sample size was 183.||||<0.0001
72553861|NCT02440711|144639741|SUPERIORITY|||||||0.002||||||Holm-Bonferroni adjustments for multiple comparisons were applied to yield an experiment-wise alpha level of .05.|t-test, 2 sided|||TAPES-AR results||||0.002
72553569|NCT00982397|144638625|NON_INFERIORITY_OR_EQUIVALENCE|Ho: p1 ≤ p2 - 0.05 Ha: p1 \> p2 - 0.05 Where p1 was the syncopal event free rate at one year post implant by programming VF NID 30/40 and p2 for NID = 18/24. If the null-hypothesis was rejected it was concluded that NID = 30/40 did not decrease the syncope free rate by more than 5% compared to NID = 18/24 and hence was non-inferior.|Risk Difference (RD)|0.0||||0.0013|TWO_SIDED|90.0|-2.7|2.7||P-Value is for non-inferiority|Farrington-Manning||The 90% Confidence Interval is for the difference (p1-p2), where p1=syncope free rate 30/40 arm and p2=syncope free rate 18/24 arm. Estimated value and confidence interval reflect percentages.|The expected syncopal event free rate was 0.984 in both programming groups. alpha, Type I error was 0.05. Power, 1-beta, was 80%. Non-inferiority margin 5% Based on the above assumptions and Farrington-Manning test, a total of 230 subjects was required. By further assuming 15% attrition rate and 5 % of crossover rate, a total of 300 subjects were needed.||2.7|-2.7|0.0013
72553570|NCT00838630|144638626|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of Variance (ANOVA) will be performed for the log-transformed AUC0-t, AUC0-inf and Cmax parameters.|Geometric Test/Ref Ratio x 100|98.27||||||90.0|92.32|104.61|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||104.61|92.32|
72553571|NCT00838630|144638627|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of Variance (ANOVA) will be performed for log-transformed AUC0-t, AUC0-inf, and Cmax parameters.|Geometric Test/Ref Ratio x 100|94.37||||||90.0|90.47|98.43|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||98.43|90.47|
72553572|NCT00838630|144638628|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of Variance (ANOVA) will be performed on log-transformed AUC0-t, AUC0-inf and Cmax parameters.|Geometric Test/Ref Ratio x 100|95.7||||||90.0|91.52|100.08|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||100.08|91.52|
72553573|NCT02363803|144638629|SUPERIORITY|||||||0.03|||||||t-test, 2 sided|Paired t-test||||||0.03
72553574|NCT03140631|144638634|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
72553575|NCT03140631|144638635|SUPERIORITY|||||||0.74|||||||Fisher Exact|||number of participants who experienced a vascular access site complication at 90 days||||0.74
72553576|NCT00838279|144638686|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|100.31||||||90.0|97.82|102.85|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||102.85|97.82|
72553577|NCT00838279|144638687|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|101.78||||||90.0|99.09|104.55|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||104.55|99.09|
72553578|NCT00838279|144638688|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|99.94||||||90.0|97.4|102.55|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||102.55|97.40|
72553579|NCT01854047|144638711|SUPERIORITY||Least Square (LS) Mean Difference|0.21||||0.0063|TWO_SIDED|95.0|0.06|0.36||Threshold for significance at 0.05.|Mixed Models Analysis||Dupilumab 300 mg q2w vs. Placebo q2w|Analysis was performed using mixed effect model with repeated measures (MMRM) approach including available FEV1 data from baseline to Week 12 and treatment group as a factor. A step-down procedure was used to strongly control the overall type I error rate for testing multiple doses against placebo. The hierarchy was 300 mg q2w, 200 mg q2w, 300 mg q4w, and 200 mg q4w.||0.36|0.06|0.0063
72553580|NCT01854047|144638711|SUPERIORITY||LS Mean Difference|0.26||||0.0008|TWO_SIDED|95.0|0.11|0.4||Threshold for significance at 0.05.|Mixed Models Analysis||Dupilumab 200 mg q2w vs. Placebo q2w|||0.40|0.11|0.0008
72553581|NCT01854047|144638711|SUPERIORITY||LS Mean Difference|0.17||||0.0212|TWO_SIDED|95.0|0.03|0.32||Threshold for significance at 0.05.|Mixed Models Analysis||Dupilumab 300 mg q4w vs. Placebo q2w|||0.32|0.03|0.0212
72553582|NCT01854047|144638711|SUPERIORITY||LS Mean Difference|0.08||||0.2774|TWO_SIDED|95.0|-0.07|0.23||Threshold for significance at 0.05.|Mixed Models Analysis||Dupilumab 200 mg q4w vs. Placebo q2w|||0.23|-0.07|0.2774
72553583|NCT01854047|144638712|SUPERIORITY||LS Mean Difference|0.16||||0.0002|TWO_SIDED|95.0|0.08|0.25||Threshold for significance at 0.05.|Mixed Models Analysis||Dupilumab 300 mg q2w vs. Placebo q2w|Analysis was performed using MMRM approach including available FEV1 data from baseline to Week 12 and treatment group as a factor. A step-down procedure was used to strongly control the overall type I error rate for testing multiple doses against placebo. The hierarchy was 300 mg q2w, 200 mg q2w, 300 mg q4w and 200 mg q4w.||0.25|0.08|0.0002
72553584|NCT01854047|144638712|SUPERIORITY||LS Mean Difference|0.2|||<|0.0001|TWO_SIDED|95.0|0.011|0.28||Threshold for significance at 0.05.|Mixed Models Analysis||Dupilumab 200 mg q2w vs. Placebo q2w|||0.28|0.011|<0.0001
72553585|NCT01854047|144638712|SUPERIORITY||LS Mean Difference|0.12||||0.0048|TWO_SIDED|95.0|0.04|0.21||Threshold for significance at 0.05.|Mixed Models Analysis||Dupilumab 300 mg q4w vs. Placebo q2w|||0.21|0.04|0.0048
72553586|NCT01854047|144638712|SUPERIORITY||LS Mean Difference|0.1||||0.0304|TWO_SIDED|95.0|0.01|0.18||Threshold for significance at 0.05.|Mixed Models Analysis||Dupilumab 200 mg q4w vs. Placebo q2w|||0.18|0.01|0.0304
72553587|NCT03273153|144638736|SUPERIORITY||Hazard Ratio (HR)|1.15||||0.2954|TWO_SIDED|95.0|0.88|1.5|||Regression, Cox|||||1.50|0.88|0.2954
72553588|NCT05323396|144638753|OTHER|||||||0.19|||||||Student's unpaired t-test|||||||0.19
72553589|NCT05323396|144638754|OTHER|||||||0.85|||||||Student's unpaired t-test|||||||0.85
72553590|NCT05323396|144638755|OTHER|||||||0.77|||||||Student's unpaired t-test|||||||0.77
72553591|NCT05323396|144638756|OTHER|||||||0.12|||||||student's unpaired t-test|||||||0.12
72553592|NCT05323396|144638757|OTHER|||||||0.81|||||||student's unpaired t-test|||||||0.81
72553593|NCT05323396|144638758|OTHER|||||||0.65|||||||student's unpaired t-test|||||||0.65
72553594|NCT00095212|144638784|SUPERIORITY_OR_OTHER|||||||0.04|||||||longitudinal linear mixed effects model|||||||0.04
72553595|NCT00095212|144638785|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||Longitudinal linear mixed effects model|||The study was powered at 80% to detect a significant treatment difference of 2.7 kg in lean body mass between the two groups with 25 randomized patients and a 15% assumed dropout rate, using a two sided 5.0 percent significance level.||||0.02
72553862|NCT02440711|144639741|SUPERIORITY||||||<|0.001||||||Holm-Bonferroni adjustments for multiple comparisons were applied to yield an experiment-wise alpha level of .05.|t-test, 2 sided|||TAPES-FUN results||||<0.001
72553596|NCT00095212|144638786|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||Longitudinal mixed methods model|||The study was powered at 80% to detect a significant treatment difference of 2.7 kg in lean body mass between the two groups with 25 randomized patients and a 15% assumed dropout rate, using a two sided 5.0 percent significance level.||||0.02
72553597|NCT00095212|144638787|SUPERIORITY_OR_OTHER|||||||0.01||95.0|||||Longitudinal mixed methods model|||The study was powered at 80% to detect a significant treatment difference of 2.7 kg in lean body mass between the two groups with 25 randomized patients and a 15% assumed dropout rate, using a two sided 5.0 percent significance level.||||0.01
72553598|NCT00095212|144638788|SUPERIORITY_OR_OTHER|||||||0.16||95.0|||||Chi-squared|||||||0.16
72553599|NCT00095212|144638789|SUPERIORITY_OR_OTHER|||||||0.29||95.0|||||Chi-squared|||||||0.29
72553600|NCT00095212|144638790|SUPERIORITY_OR_OTHER|||||||0.75||95.0|||||Chi-squared|||||||0.75
72553601|NCT00095212|144638791|SUPERIORITY_OR_OTHER|||||||0.14||95.0|||||Chi-squared|||||||0.14
72553602|NCT00095212|144638792|SUPERIORITY_OR_OTHER|||||||0.26||95.0|||||t-test, 2 sided|||||||0.26
72553603|NCT00095212|144638793|SUPERIORITY_OR_OTHER|||||||0.22||95.0|||||t-test, 2 sided|||||||0.22
72553604|NCT00095212|144638794|SUPERIORITY_OR_OTHER|||||||0.94||95.0|||||t-test, 2 sided|||||||0.94
72553605|NCT01379664|144638812|SUPERIORITY_OR_OTHER||Ratio of Geometric Means|1.06||||0.24|TWO_SIDED|95.0|0.97|1.16|||Wilcoxon (Mann-Whitney)|||||1.16|0.97|0.24
72553606|NCT01379664|144638813|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02||||0.87|TWO_SIDED|95.0|-0.23|0.19|||Generalized estimating equation model|Generalized estimating equation model weighted by inverse propensity score||||0.19|-0.23|0.87
72553607|NCT01379664|144638814|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.69||||0.74|TWO_SIDED|95.0|-4.7|3.3|||Generalized estimating equation model|Generalized estimating equation model weighted by propensity score||||3.3|-4.7|0.74
72553608|NCT04189848|144638915|OTHER|Treatment comparison|Treatment difference|-5.9|||<|0.0001|TWO_SIDED|95.0|-8.2|-3.6|||ANOVA|||Intensity of injection site pain was analysed by a fixed analysis of variance model with VAS pain score as the dependent variable, and product, injection side (right side, left side), injection number (first injection, second injection), and participant as fixed effects.||-3.6|-8.2|<0.0001
72553609|NCT00819741|144638918|NON_INFERIORITY_OR_EQUIVALENCE|"If non-inferiority was shown (that was if H0 was rejected), then superiority of repaglinide and metformin combination therapy compared to repaglinide monotherapy would be claimed if the upper limit of the 95% CI for the difference was lower than 0%.~The non-inferiority margin for HbA1c was set to 0.4%."|Estimated treatment difference, LS Mean|-0.302|STANDARD_ERROR_OF_MEAN|0.0096||||95.0|-0.491|-0.114|||ANCOVA|||"The non-inferiority margin for HbA1c was set to 0.4%.~The null hypothesis (H0) was:~H0: HbA1c of repaglinide + metformin therapy after 16 weeks of treatment - HbA1c of repaglinide monotherapy after 16 weeks of treatment ≥0.4%~Against the alternative hypothesis (H1):~H1: HbA1c of repaglinide + metformin therapy after 16 weeks of treatment - HbA1c of repaglinide monotherapy after 16 weeks of treatment \<0.4%"||-0.114|-0.491|
72553610|NCT00119015|144638933|SUPERIORITY_OR_OTHER|||||||0.8||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.8
72553611|NCT00119015|144638934|SUPERIORITY_OR_OTHER|||||||0.7||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.70
72553612|NCT00119015|144638935|SUPERIORITY_OR_OTHER|||||||0.86||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.86
72553613|NCT00119015|144638936|SUPERIORITY_OR_OTHER|||||||0.48||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.48
72553614|NCT00119015|144638937|SUPERIORITY_OR_OTHER||||||>|0.99||95.0|||||Wilcoxon (Mann-Whitney)|||||||>0.99
72553615|NCT01597245|144638938|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
72553616|NCT01597245|144638938|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
72553617|NCT01597245|144638938|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
72553618|NCT01597245|144638939|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
72553619|NCT01597245|144638939|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
72553620|NCT01597245|144638939|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
72553621|NCT01597245|144638940|SUPERIORITY_OR_OTHER_LEGACY|||||||0.005|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.005
72553622|NCT01597245|144638940|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
72553623|NCT01597245|144638940|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
72553624|NCT01597245|144638941|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
72553625|NCT01597245|144638941|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
72553626|NCT01597245|144638941|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
72553627|NCT01597245|144638942|SUPERIORITY_OR_OTHER_LEGACY|||||||0.008|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.008
72553628|NCT01597245|144638942|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
72553629|NCT01597245|144638942|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
72553630|NCT01597245|144638943|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Fisher Exact|||||||<0.001
72553631|NCT01597245|144638943|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Fisher Exact|||||||<0.001
72553632|NCT01597245|144638944|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
72553633|NCT01597245|144638944|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
72553634|NCT01597245|144638944|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
72553635|NCT01597245|144638945|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
72553636|NCT01597245|144638945|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
72553637|NCT01597245|144638945|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
72553638|NCT01597245|144638946|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002|TWO_SIDED||||||Mixed Models Analysis|||||||0.002
72553639|NCT01597245|144638946|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
72553640|NCT01597245|144638946|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
72553641|NCT01597245|144638947|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
72553642|NCT01597245|144638947|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
72553643|NCT01597245|144638947|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
72553644|NCT01597245|144638948|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
72553645|NCT01597245|144638948|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
72553646|NCT01597245|144638948|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
72553647|NCT01597245|144638949|SUPERIORITY_OR_OTHER_LEGACY|||||||0.15|TWO_SIDED||||||ANCOVA|||||||0.150
72553648|NCT01597245|144638949|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002|TWO_SIDED||||||ANCOVA|||||||0.002
72553649|NCT01597245|144638949|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||ANCOVA|||||||<0.001
72553650|NCT01597245|144638950|SUPERIORITY_OR_OTHER_LEGACY|||||||0.026|TWO_SIDED||||||ANCOVA|||Absenteeism Score||||0.026
72553651|NCT01597245|144638950|SUPERIORITY_OR_OTHER_LEGACY|||||||0.076|TWO_SIDED||||||ANCOVA|||Absenteeism Score||||0.076
72553652|NCT01597245|144638950|SUPERIORITY_OR_OTHER_LEGACY|||||||0.016|TWO_SIDED||||||ANCOVA|||Absenteeism Score||||0.016
72553653|NCT01597245|144638950|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||ANCOVA|||Activity Impairment Score||||<0.001
72553654|NCT01597245|144638950|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||ANCOVA|||Activity Impairment Score||||<0.001
72553655|NCT01597245|144638950|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||ANCOVA|||Activity Impairment Score||||<0.001
72553656|NCT01597245|144638950|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||ANCOVA|||Presenteeism Score||||<0.001
72553657|NCT01597245|144638950|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||ANCOVA|||Presenteeism Score||||<0.001
72553658|NCT01597245|144638950|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||ANCOVA|||Presenteeism Score||||<0.001
72553659|NCT01597245|144638950|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||ANCOVA|||Work Productivity Loss Score||||<0.001
72553660|NCT01597245|144638950|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||ANCOVA|||Work Productivity Loss Score||||<0.001
72553661|NCT01597245|144638950|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||ANCOVA|||Work Productivity Loss Score||||<0.001
72553662|NCT01597245|144638951|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||ANCOVA|||Physical Summary Score||||<0.001
72553663|NCT01597245|144638951|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||ANCOVA|||Physical Summary Score||||<0.001
72553664|NCT01597245|144638951|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||ANCOVA|||Physical Summary Score||||<0.001
72553665|NCT01597245|144638951|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||ANCOVA|||Mental Summary Score||||<0.001
72553666|NCT01597245|144638951|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||ANCOVA|||Mental Summary Score||||<0.001
72553667|NCT01597245|144638951|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||ANCOVA|||Mental Summary Score||||<0.001
72553668|NCT01597245|144638952|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
72553669|NCT01597245|144638952|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
72553670|NCT01597245|144638952|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
72553671|NCT01597245|144638953|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||PPASI 50||||<0.001
72553672|NCT01597245|144638953|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||PPASI 50||||<0.001
72553673|NCT01597245|144638953|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||PPASI 50||||<0.001
72553674|NCT01597245|144638953|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||PPASI 75||||<0.001
72553675|NCT01597245|144638953|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||PPASI 75||||<0.001
72553676|NCT01597245|144638953|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||PPASI 75||||<0.001
72553677|NCT01597245|144638953|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002|TWO_SIDED||||||Cochran-Mantel-Haenszel|||PPASI 100||||0.002
72553678|NCT01597245|144638953|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||PPASI 100||||<0.001
72553679|NCT01597245|144638953|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||PPASI 100||||<0.001
72553680|NCT00731783|144638957|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.03||||1|TWO_SIDED|95.0|0.54|1.97|||Fisher Exact|||||1.97|0.54|1.00
72553681|NCT00731783|144638958|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.17||||0.05|TWO_SIDED|95.0|1.03|4.55|||Fisher Exact|||||4.55|1.03|0.05
72553682|NCT00731783|144638959|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.77||||0.49|TWO_SIDED|95.0|0.39|1.52|||Fisher Exact|||||1.52|0.39|0.49
72553683|NCT00731783|144638960|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.59||||0.28|TWO_SIDED|95.0|0.77|3.28|||Fisher Exact|||||3.28|0.77|0.28
72553684|NCT00731783|144638961|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.52||||0.12|TWO_SIDED|95.0|0.23|1.16|||Fisher Exact|||||1.16|0.23|0.12
72553685|NCT00731783|144638962|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.42||||0.02|TWO_SIDED|95.0|0.21|0.85|||Fisher Exact|||||0.85|0.21|0.02
72553686|NCT00731783|144638963|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.39||||0.008|TWO_SIDED|95.0|0.2|0.77|||Fisher Exact|||||0.77|0.20|0.008
72553687|NCT00731783|144638964|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.43||||0.02|TWO_SIDED|95.0|0.22|0.86|||Fisher Exact|||||0.86|0.22|0.02
72553688|NCT01281501|144638986|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.6|STANDARD_DEVIATION|5.0||0.6|TWO_SIDED|95.0|-12.7|7.4|||t-test, 2 sided|||Null hypothesis is that the treatment with pantoprazole arm is not different in immediate relief of acute, severe dyspeptic pain compared with conventional arm.||7.4|-12.7|0.6
72553689|NCT02996591|144639020|OTHER||generalized estimating equations method|45.0||||0.038|TWO_SIDED||||||Regression, Logistic|||||||.038
72553690|NCT02996591|144639020|OTHER|Bang blinding index|||||<|0.001|||||||Bang Blinding Index|95% confidence interval||||||<.001
72553691|NCT00461786|144639032|SUPERIORITY_OR_OTHER||Overall Response Rate|21.0||||||95.0|10.5|35.0||||||Overall Response Rate is the total percentage of participants with either a complete response or a partial response (CR+PR)/48 X 100.||35.0|10.5|
72553692|NCT00835991|144639037|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|114.05||||||90.0|107.26|121.27|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||121.27|107.26|
72553693|NCT00835991|144639038|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|100.63||||||90.0|97.59|103.76|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||103.76|97.59|
72553694|NCT00835991|144639039|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|101.36||||||90.0|98.32|104.48|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||104.48|98.32|
72553695|NCT00835991|144639040|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|99.05||||||90.0|94.31|104.02|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||104.02|94.31|
72553696|NCT00835991|144639041|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05|Test/Ref Ratio of LS Means x 100|96.55||||||90.0|93.85|99.32|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||99.32|93.85|
72553697|NCT00835991|144639042|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|96.44||||||90.0|93.71|99.25|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||99.25|93.71|
72553698|NCT02149420|144639043|SUPERIORITY||Mean Difference (Final Values)|-0.93|STANDARD_DEVIATION|2.058||0.678|TWO_SIDED|95.0|-5.007|3.18|||repeated measures Bayesian analysis|with baseline as a covariate||Per protocol the primary analysis was between placebo and the combined VAY736 groups at Week 12.||3.180|-5.007|0.678
72553699|NCT00984022|144639141|SUPERIORITY_OR_OTHER|||||||0.0003||95.0|||||Fisher Exact|||The percentages achieving 30% or greater reduction in the surface area of the abscess were compared with Fisher's exact test.||||.0003
72553700|NCT00984022|144639142|SUPERIORITY_OR_OTHER|||||||0.043||95.0||||Main effect for type of dressing.|ANOVA|||Repeated measures ANOVA using 2 X 2 factorial design, with one between-subjects factor (Group) and one within-subjects factor (Time). Null hypothesis is: The type of dressing does not affect patient pain ratings.||||.043
72553701|NCT00984022|144639143|SUPERIORITY_OR_OTHER|||||||0.847||95.0|||||Fisher Exact|||Fisher's exact test was used to compare the percentage of individuals achieving a 30% or greater reduction in cellulitis surface area between the Iodoform and Aquacel groups.||||.847
72553702|NCT00573443|144639145|SUPERIORITY_OR_OTHER||Ratio of episode-rate reduction ratios|0.5312|||<|0.0001|TWO_SIDED|95.0|0.4939|0.5714|||Regression, Longitudinal neg. binomial|||Analysis of PBA episode rates used longitudinal negative binomial regression with treatment, period, diagnosis and study site to estimate pre-post changes in log mean episode rate for each treatment group. Null hypothesis of equal pre-post episode rate reductions were tested: AVP-923-30/placebo = 1.||0.5714|0.4939|<0.0001
72553703|NCT00573443|144639145|SUPERIORITY_OR_OTHER||Ratio of episode-rate reduction ratios|0.5103|||<|0.0001|TWO_SIDED|95.0|0.4755|0.5477|||Regression, Longitudinal neg. binomial|||Analysis of PBA episode rates used longitudinal negative binomial regression with treatment, period, diagnosis and study site to estimate pre-post changes in log mean episode rate for each treatment group. Null hypothesis of equal pre-post episode rate reductions were tested: AVP-923-20/placebo = 1.||0.5477|0.4755|<0.0001
72553704|NCT00905606|144639152|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|ANOVA was performed on ln-transformed AUC0-t, AUC0-72h, and Cmax. All analyses were performed according to FDA guidelines.|Ratio of the LS Mean (test/ref x 100)|93.91||||||90.0|85.42|103.25|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||103.25|85.42|
72553705|NCT00905606|144639153|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|ANOVA was performed on ln-transformed AUC0-t, AUC0-72h, and Cmax. All analyses were performed according to FDA guidelines.|Ratio of the LS Mean (test/ref x 100)|98.27||||||90.0|94.63|102.05|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||102.05|94.63|
72553706|NCT00905606|144639154|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|ANOVA was performed on ln-transformed AUC0-t, AUC0-72h, and Cmax. All analyses were performed according to FDA guidelines.|Ratio of the LS Mean (test/ref x 100)|98.19||||||90.0|94.64|101.87|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||101.87|94.64|
72553707|NCT00804856|144639168|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.91||||0.0523|TWO_SIDED|95.0|0.99|8.58|||Regression, Logistic||Ratio calculated as Phase II Schedule A Volasertib 350mg+LDAC divided by Phase II Schedule C LDAC.|Analysis for Objective Response||8.58|0.99|0.0523
72553708|NCT00804856|144639172|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.57||||0.0208|TWO_SIDED|95.0|0.35|0.92|||Log Rank||Ratio calculated as Phase II Schedule A Volasertib 350mg+LDAC divided by Phase II Schedule C LDAC.|An exploratory (non-stratified) logrank test was used to compare the different treatment arms.||0.92|0.35|0.0208
72553709|NCT00804856|144639173|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.63||||0.0465|TWO_SIDED|95.0|0.4|1.0|||Log Rank||Ratio calculated as Phase II Schedule A Volasertib 350mg+LDAC divided by Phase II Schedule C LDAC.|An exploratory (non-stratified) logrank test was used to compare the different treatment arms.||1.00|0.40|0.0465
72553710|NCT00418561|144639190|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0737|TWO_SIDED|||||Test for no difference between cohorts.|ANOVA|||The comparisons of the three doses were done using analysis of variance (ANOVA) model including the baseline measurement as a covariate.||||0.0737
72553711|NCT00418561|144639191|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1115|TWO_SIDED|||||Test for no difference between cohorts.|ANOVA|||The comparisons of the three doses were done using ANOVA model including the baseline measurement as a covariate.||||0.1115
72553712|NCT00418561|144639193|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1268|TWO_SIDED|||||Test for no difference between cohorts.|ANOVA|||The comparisons of the three doses were done using ANOVA model including the baseline measurement as a covariate.||||0.1268
72553713|NCT00829309|144639213|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Geometric Test/Ref Ratio x 100|98.45||||||90.0|80.08|121.03|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||121.03|80.08|
72553714|NCT00829309|144639214|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Geometric Test/Ref Ratio x 100|90.98||||||90.0|85.23|97.12|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||97.12|85.23|
72553715|NCT00829309|144639215|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Geometric Test/Ref Ratio x 100|96.3||||||90.0|85.34|108.66|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||108.66|85.34|
72553716|NCT00777023|144639245|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.61|STANDARD_ERROR_OF_MEAN|0.53||0.0024|TWO_SIDED|97.5|-2.8|-0.42||P value for pairwise test of difference of least square mean change from baseline between G-ER 1200 mg and placebo groups based on F test of type III analysis.|ANCOVA|||Null hypothesis: no treatment differences relative to placebo in mean change from baseline in average daily number of moderate or severe hot flashes at SDW 4||-0.42|-2.80|0.0024
72553717|NCT00777023|144639245|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.51|STANDARD_ERROR_OF_MEAN|0.52||0.004|TWO_SIDED|97.5|-2.69|-0.33||P value for pairwise test of difference of least square mean change from baseline between G-ER 1800 mg and placebo groups based on F test of type III analysis.|ANCOVA|||Null hypothesis: no treatment differences relative to placebo in mean change from baseline in average daily number of moderate or severe hot flashes at SDW 4||-0.33|-2.69|0.0040
72553718|NCT00777023|144639246|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.56|STANDARD_ERROR_OF_MEAN|0.51||0.0024|TWO_SIDED|97.5|-2.72|-0.41||P value for pairwise test of difference of least square mean change from baseline between G-ER 1200 mg and placebo groups based on F test of type III analysis.|ANCOVA|||Null hypothesis: no treatment differences relative to placebo in mean change from baseline in average daily number of moderate or severe hot flashes at SDW 12||-0.41|-2.72|0.0024
72553719|NCT00777023|144639246|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.12|STANDARD_ERROR_OF_MEAN|0.51||0.0281|TWO_SIDED|97.5|-2.26|0.02||P value for pairwise test of difference of least square mean change from baseline between G-ER 1800 mg and placebo groups based on F test of type III analysis.|ANCOVA|||Null hypothesis: no treatment differences relative to placebo in mean change from baseline in average daily number of moderate or severe hot flashes at SDW 12||0.02|-2.26|0.0281
72553720|NCT00777023|144639247|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.15|STANDARD_ERROR_OF_MEAN|0.08||0.0608|TWO_SIDED|97.5|-0.32|-0.03||P value for pairwise test of difference of least square mean change from baseline between G-ER 1200 mg and placebo groups based on F test of type III analysis.|ANCOVA|||Null hypothesis: no treatment differences relative to placebo in mean change from baseline in average daily severity score of moderate or severe hot flashes at SDW 4||-0.03|-0.32|0.0608
72553721|NCT00777023|144639247|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.28|STANDARD_ERROR_OF_MEAN|0.08||0.0003|TWO_SIDED|97.5|-0.45|-0.11||P value for pairwise test of difference of least square mean change from baseline between G-ER 1800 mg and placebo groups based on F test of type III analysis.|ANCOVA|||Null hypothesis: no treatment differences relative to placebo in mean change from baseline in average daily severity score of moderate or severe hot flashes at SDW 4||-0.11|-0.45|0.0003
72553722|NCT00777023|144639248|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.21|STANDARD_ERROR_OF_MEAN|0.1||0.028|TWO_SIDED|97.5|-0.43|0.0||P value for pairwise test of difference of least square mean change from baseline between G-ER 1200 mg and placebo groups based on F test of type III analysis.|ANCOVA|||Null hypothesis: no treatment differences relative to placebo in mean change from baseline in average daily severity score of moderate or severe hot flashes at SDW 12||0.00|-0.43|0.0280
72553723|NCT00777023|144639248|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.29|STANDARD_ERROR_OF_MEAN|0.1||0.0026|TWO_SIDED|97.5|-0.51|-0.07||P value for pairwise test of difference of least square mean change from baseline between G-ER 1800 mg and placebo groups based on F test of type III analysis.|ANCOVA|||Null hypothesis: no treatment differences relative to placebo in mean change from baseline in average daily severity score of moderate or severe hot flashes at SDW 12||-0.07|-0.51|0.0026
72553724|NCT02659150|144639249|SUPERIORITY||Mean Difference (Final Values)|-0.1|STANDARD_DEVIATION|0.24||0.26|TWO_SIDED||||||t-test, 2 sided|||Paired T-test comparing values obtained during the follow-up imaging (at 13-18 weeks)minus the baseline values||||0.26
72553725|NCT02659150|144639250|OTHER||Spearman Correlation Coefficient|0.76||||0.036|TWO_SIDED||||||Spearman|||correlation coefficient||||0.036
72553726|NCT02659150|144639251|SUPERIORITY||Mean Difference (Final Values)|-0.19|STANDARD_DEVIATION|0.32||0.14|TWO_SIDED||||||t-test, 2 sided|||The carotid artery plaque with highest FDG uptake is located using Positron Emission Tomography/ Magnetic Resonance Imaging images. Thereafter Paired T- Test is used to compare baseline vs follow-up values of FDG uptake (before vs after 12 weeks of tocilizumab treatment). FDG uptake is assessed as a Target to background values (TBR) , which is calculated as the mean arterial standardized uptake value (SUV) divided by background blood pool SUV.||||0.14
72553727|NCT02659150|144639252|SUPERIORITY||correlation coefficient|-0.66||||0.076|TWO_SIDED||||||Spearman's Method|||||||0.076
72553728|NCT02659150|144639253|SUPERIORITY||Correlation coefficient|0.67||||0.07|TWO_SIDED||||||Spearman's Method|||||||0.07
72553729|NCT02246920|144639259|EQUIVALENCE|Equivalence is established if the 90% confidence interval is contained within 80.00-125.00%.|T/R Ls Mean Ratio|108.09|||||TWO_SIDED|90.0|94.09|124.4||||||||124.40|94.09|
72553730|NCT02246920|144639260|EQUIVALENCE|Equivalence is demonstrated when the 90% confidence interval is contained within 80.00-125.00%.|T/R LS Mean Ratio|107.0|||||TWO_SIDED|90.0|92.42|124.09||||||||124.09|92.42|
72553731|NCT02246920|144639261|SUPERIORITY|||||||0.0028|||||||ANCOVA|||||||0.0028
72553732|NCT02246920|144639261|SUPERIORITY|||||||0.0169|||||||ANCOVA|||||||0.0169
72553733|NCT00904215|144639301|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Student Paired t-test|||||||<0.0001
72553734|NCT00904215|144639302|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Student Paired t-test|||||||<0.0001
72553735|NCT00904215|144639303|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Student Paired t-test|||||||<0.0001
72553736|NCT00904215|144639304|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Student Paired t-test|||||||<0.0001
72553737|NCT00244764|144639305|SUPERIORITY_OR_OTHER||percentage|34.7||||||95.0|28.4|40.9|||||The estimated value provided is the response rate.|||40.9|28.4|
72553738|NCT00244764|144639306|SUPERIORITY_OR_OTHER||percentage|42.0||||||95.0|29.0|54.0|||||The estimated value is the percentage of the first 60 participants who had stable disease at Week 12, as assessed by the investigator.|||54|29|
72553739|NCT03872128|144639343|SUPERIORITY|||||||0.009|||||||Fisher Exact|||||||0.009
72553740|NCT03872128|144639344|SUPERIORITY|||||||0.019|||||||Fisher Exact|||||||0.019
72553741|NCT03872128|144639345|SUPERIORITY|||||||0.044|||||||Fisher Exact|||||||0.044
72553742|NCT03872128|144639346|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||OCDS: Total||||<0.001
72553743|NCT03872128|144639346|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||OCDS: Obsessive||||<0.001
72553744|NCT03872128|144639346|SUPERIORITY|||||||0.003|||||||Fisher Exact|||OCDS: Compulsive||||0.003
72553745|NCT03872128|144639348|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||||||<.0001
72553746|NCT03872128|144639349|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||HADS-Depression||||<0.001
72553747|NCT03872128|144639349|SUPERIORITY|||||||0.089|||||||Fisher Exact|||HADS-Anxiety||||0.089
72553748|NCT03285594|144639359|SUPERIORITY||Difference in Least Square (LS) Means|-0.45|STANDARD_ERROR_OF_MEAN|0.094|<|0.0001|TWO_SIDED|95.0|-0.638|-0.271|||ANCOVA|||The change from baseline to Week 18 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at Week -1, randomization strata of mean SBP (\<130, ≥130 mmHg) at Week -1, randomization strata of sulfonylureas use (yes, no) at Week -1, and country as fixed effects, and baseline HbA1c as a covariate.||-0.271|-0.638|<0.0001
72553749|NCT03285594|144639359|SUPERIORITY||Difference in LS Means|-0.55|STANDARD_ERROR_OF_MEAN|0.081|<|0.0001|TWO_SIDED|95.0|-0.706|-0.387|||ANCOVA|||The change from baseline to Week 18 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at Week -1, randomization strata of mean SBP (\<130, ≥130 mmHg) at Week -1, randomization strata of sulfonylureas use (yes, no) at Week -1, and country as fixed effects, and baseline HbA1c as a covariate.||-0.387|-0.706|<0.0001
72553750|NCT03285594|144639360|SUPERIORITY||Difference in LS Means|-15.858|STANDARD_ERROR_OF_MEAN|4.6056||0.0006|TWO_SIDED|95.0|-24.8845|-6.8309|||ANCOVA|||The change from baseline to Week 18 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at Week -1, randomization strata of mean SBP (\<130, ≥130 mmHg) at Week -1, randomization strata of sulfonylureas use (yes, no) at Week -1, and country as fixed effects, and baseline FPG as a covariate.||-6.8309|-24.8845|0.0006
72553751|NCT03285594|144639360|SUPERIORITY||Difference in LS Means|-21.832|STANDARD_ERROR_OF_MEAN|4.0514|<|0.0001|TWO_SIDED|95.0|-29.7725|-13.8911|||ANCOVA|||The change from baseline to Week 18 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at Week -1, randomization strata of mean SBP (\<130, ≥130 mmHg) at Week -1, randomization strata of sulfonylureas use (yes, no) at Week -1, and country as fixed effects, and baseline FPG as a covariate.||-13.8911|-29.7725|<0.0001
72553752|NCT03285594|144639361|SUPERIORITY||Difference in LS Means|-1.09|STANDARD_ERROR_OF_MEAN|0.32||0.0007|TWO_SIDED|95.0|-1.716|-0.462|||ANCOVA|||The change from baseline to Week 18 is analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at Week -1, randomization strata of mean SBP (\<130, ≥130 mmHg) at Week -1, randomization strata of sulfonylureas use (yes, no) at Week -1, and country as fixed effects, and baseline body weight as a covariate.||-0.462|-1.716|0.0007
72553753|NCT03285594|144639361|SUPERIORITY||Difference in LS Means|-1.73|STANDARD_ERROR_OF_MEAN|0.278|<|0.0001|TWO_SIDED|95.0|-2.274|-1.183|||ANCOVA|||The change from baseline to Week 18 is analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at Week -1, randomization strata of mean SBP (\<130, ≥130 mmHg) at Week -1, randomization strata of sulfonylureas use (yes, no) at Week -1, and country as fixed effects, and baseline body weight as a covariate.||-1.183|-2.274|<0.0001
72553754|NCT03285594|144639362|SUPERIORITY||Difference in LS Means|-3.91|STANDARD_ERROR_OF_MEAN|1.904||0.04|TWO_SIDED|95.0|-7.642|-0.178|||ANCOVA|||The change from baseline to Week 12 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at Week -1, randomization strata of sulfonylureas use (yes, no) at Week -1, and country as fixed effects, and baseline SBP as a covariate.||-0.178|-7.642|0.04
72553755|NCT03285594|144639362|SUPERIORITY||Difference in LS Means|-3.83|STANDARD_ERROR_OF_MEAN|1.697||0.0239|TWO_SIDED|95.0|-7.161|-0.507|||ANCOVA|||The change from baseline to Week 12 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at Week -1, randomization strata of sulfonylureas use (yes, no) at Week -1, and country as fixed effects, and baseline SBP as a covariate.||-0.507|-7.161|0.0239
72553756|NCT03285594|144639363|SUPERIORITY||Difference in LS Means|-4.94|STANDARD_ERROR_OF_MEAN|1.425|||TWO_SIDED|95.0|-7.73|-2.142||||||The change from baseline to Week 12 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at Week -1, randomization strata of mean SBP (\<130, ≥130 mmHg) at Week -1, randomization strata of sulfonylureas use (yes, no) at Week -1, and country as fixed effects, and baseline SBP as a covariate.||-2.142|-7.73|
72553757|NCT03285594|144639363|SUPERIORITY||Difference in LS Means|-3.89|STANDARD_ERROR_OF_MEAN|1.246||0.0018|TWO_SIDED|95.0|-6.333|-1.448|||ANCOVA|||The change from baseline to Week 12 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at Week -1, randomization strata of mean SBP (\<130, ≥130 mmHg) at Week -1, randomization strata of sulfonylureas use (yes, no) at Week -1, and country as fixed effects, and baseline SBP as a covariate.||-1.448|-6.333|0.0018
72553758|NCT03285594|144639364|SUPERIORITY||Difference in LS Means|-0.52|STANDARD_ERROR_OF_MEAN|0.34||0.1265|TWO_SIDED|95.0|-1.185|0.147|||ANCOVA|||The change from baseline to Week 52 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at Week -1, randomization strata of mean SBP (\<130, ≥130 mmHg) at Week -1, randomization strata of sulfonylureas use (yes, no) at Week -1, and country as fixed effects, and baseline HbA1c as a covariate.||0.147|-1.185|0.1265
72553759|NCT03285594|144639364|SUPERIORITY||Difference in LS Means|-0.57|STANDARD_ERROR_OF_MEAN|0.32||0.074|TWO_SIDED|95.0|-1.199|0.055|||ANCOVA|||The change from baseline to Week 52 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at Week -1, randomization strata of mean SBP (\<130, ≥130 mmHg) at Week -1, randomization strata of sulfonylureas use (yes, no) at Week -1, and country as fixed effects, and baseline HbA1c as a covariate.||0.055|-1.199|0.074
72553760|NCT03285594|144639365|SUPERIORITY||Difference in LS Means|-1.01|STANDARD_ERROR_OF_MEAN|0.868||0.2466|TWO_SIDED|95.0|-2.707|0.696|||ANCOVA|||The change from baseline to Week 18 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at Week -1, randomization strata of mean SBP (\<130, ≥130 mmHg) at Week -1, randomization strata of sulfonylureas use (yes, no) at Week -1, and country as fixed effects, and baseline body weight as a covariate.||0.696|-2.707|0.2466
72553761|NCT03285594|144639365|SUPERIORITY||Difference in LS Means|-0.65|STANDARD_ERROR_OF_MEAN|0.672||0.332|TWO_SIDED|95.0|-1.969|0.665|||ANCOVA|||The change from baseline to Week 18 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at Week -1, randomization strata of mean SBP (\<130, ≥130 mmHg) at Week -1, randomization strata of sulfonylureas use (yes, no) at Week -1, and country as fixed effects, and baseline body weight as a covariate.||0.665|-1.969|0.332
72553762|NCT02648438|144639381|SUPERIORITY_OR_OTHER||Geometric mean ratio|62.61|||||TWO_SIDED|90.0|53.01|73.94|||||Ratio (%)|Statistical Assessment of AZD7594 Pharmacokinetic Parameter (AUC0-t) Following Inhalation Administration ofAZD7594 via DPI Device 2 Versus DPI Device 1.||73.94|53.01|
72553763|NCT02648438|144639382|SUPERIORITY_OR_OTHER||Geometric mean ratio|101.15|||||TWO_SIDED|90.0|85.21|120.06|||||Ratio (%)|Statistical Assessment of AZD7594 Pharmacokinetic Parameter (AUC0-t) Following Inhalation Administration ofAZD7594 via DPI Device 2 Versus DPI Device 1.||120.06|85.21|
72553764|NCT00840411|144639461|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using PROC GLM procedures in SAS, analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Test/Ref Ratio of LS Means x 100|100.0||||||90.0|93.3|107.1|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||107.1|93.3|
72553765|NCT00840411|144639462|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using PROC GLM procedures in SAS, analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Ratio of Least Squares Means|86.5||||||90.0|80.1|93.4|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||93.4|80.1|
72553766|NCT00840411|144639463|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using PROC GLM procedures in SAS, analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Ratio of Least Squares Means|87.2||||||90.0|81.0|93.8|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||93.8|81.0|
72553767|NCT01985308|144639464|SUPERIORITY|||||||0.0002|||||||t-test, 2 sided|||||||0.0002
72553768|NCT05472038|144639492|SUPERIORITY|Superiority based on GMR was declared if the lower limit of the 2-sided 95% CI for the GMR was greater than 1.|Model-Based GMR|2.91|||||TWO_SIDED|95.0|2.45|3.44||||||||3.44|2.45|
72553769|NCT05472038|144639493|NON_INFERIORITY|Noninferiority based on seroresponse was declared if the lower limit of the 2-sided 95% CI for the difference in percentages of participants with seroresponse is \>-5%.|Adjusted Difference in Percentages|26.77|||||TWO_SIDED|95.0|19.59|33.95|||||Adjusted difference and 2-Sided CI based on the Miettinen and Nurminen method stratified by baseline NT category (\< median,\>= median) for difference in proportions. The median of baseline NT was calculated based on pooled data in 2 comparator groups.|||33.95|19.59|
72553770|NCT05472038|144639494|NON_INFERIORITY|Noninferiority based on the GMR was declared if the lower limit of the 2-sided 95% CI for the GMR is greater than 0.67 (1.5-fold criterion) and the point estimate of the GMR was \>=0.8.|Model-Based GMR|0.98|||||TWO_SIDED|95.0|0.83|1.16|||||GMR and 2-sided 95% CIs were calculated by exponentiating the difference of LS means and corresponding CIs based on the regression model included terms for baseline neutralizing titer and comparison group.|||1.16|0.83|
72553771|NCT05472038|144639495|NON_INFERIORITY|Noninferiority based on seroresponse was declared if the lower limit of the 2-sided 95% CI for the difference in percentages of participants with seroresponse is \>-10%.|Adjusted Difference in Percentages|-3.03|||||TWO_SIDED|95.0|-9.68|3.63|||||2-Sided CI based on Miettinen and Nurminen method stratified by baseline NT category(\< median,\>= median)for difference in percentage(seroresponse rate).Median of baseline neutralizing titers was calculated based on pooled data in 2 comparator groups.|||3.63|-9.68|
72553772|NCT05472038|144639500|NON_INFERIORITY|Noninferiority based on the GMR was declared if the lower limit of the 2-sided 95% CI for the GMR is greater than 0.67 (1.5-fold criterion) and the point estimate of the GMR was \>=0.8.|Model-Based GMR|1.38|||||TWO_SIDED|95.0|1.22|1.56|||||GMR and 2-sided 95% CIs were calculated by exponentiating the difference of LS means and corresponding CIs based on the regression model included terms for baseline neutralizing titer and comparison group.|||1.56|1.22|
72553773|NCT04934722|144639528|OTHER||Hazard Ratio (HR)|0.74|||||TWO_SIDED|95.0|0.24|2.34|||||HR and associated 95% Confidence Interval (CI) were calculated using Cox regression model with Efron's method of tie handling with treatment as a covariate.|||2.34|0.24|
72553774|NCT04934722|144639529|OTHER||Hazard Ratio (HR)|1.35|||||TWO_SIDED|95.0|0.3|6.01|||||HR and associated 95% Confidence Interval (CI) were calculated using Cox regression model with Efron's method of tie handling with treatment as a covariate.|||6.01|0.30|
72553775|NCT04934722|144639530|OTHER||Hazard Ratio (HR)|1.35|||||TWO_SIDED|95.0|0.5|3.63|||||HR and associated 95% Confidence Interval (CI) were calculated using Cox regression model with Efron's method of tie handling with treatment as a covariate.|||3.63|0.50|
72553776|NCT04934722|144639532|OTHER||Hazard Ratio (HR)|3.15|||||TWO_SIDED|95.0|0.33|30.29|||||HR and associated 95% Confidence Interval (CI) were calculated using Cox regression model with Efron's method of tie handling with treatment as a covariate.|||30.29|0.33|
72553777|NCT04934722|144639533|OTHER||Hazard Ratio (HR)|0.68|||||TWO_SIDED|95.0|0.11|4.07|||||HR and associated 95% Confidence Interval (CI) were calculated using Cox regression model with Efron's method of tie handling with treatment as a covariate.|||4.07|0.11|
72553778|NCT04934722|144639534|OTHER||Hazard Ratio (HR)|1.45|||||TWO_SIDED|95.0|0.73|2.9|||||HR and associated 95% Confidence Interval (CI) were calculated using Cox regression model with Efron's method of tie handling with treatment as a covariate.|||2.90|0.73|
72553779|NCT04934722|144639535|OTHER||Hazard Ratio (HR)|1.75|||||TWO_SIDED|95.0|0.42|7.34|||||HR and associated 95% Confidence Interval (CI) were calculated using Cox regression model with Efron's method of tie handling with treatment as a covariate.|||7.34|0.42|
72553780|NCT04934722|144639536|OTHER||Percent Difference|-5.5|||||TWO_SIDED|95.0|-12.6|0.0|||||Percent difference and associated 95% CI were calculated using Miettinen \& Nurminen method.|||0.0|-12.6|
72553781|NCT04934722|144639537|OTHER||Percent difference|-0.7|||||TWO_SIDED|95.0|-15.0|13.7|||||Percent difference and associated 95% CI were calculated using Miettinen \& Nurminen method.|||13.7|-15.0|
72553782|NCT04934722|144639538|OTHER||Percent difference|7.8|||||TWO_SIDED|95.0|-12.5|27.1|||||Percent difference and associated 95% CI were calculated using Miettinen \& Nurminen method.|||27.1|-12.5|
72553783|NCT00467896|144639565|SUPERIORITY_OR_OTHER||Mean Difference (Net)|49.8|||<|0.0001|TWO_SIDED|95.0|39.55|60.15|||t-test, 2 sided|||Comparison of the change in inhalation-times rate from Period I (PD-6) to Period II (PD-15)||60.15|39.55|<0.0001
72553863|NCT02440711|144639741|SUPERIORITY|||||||0.85||||||Holm-Bonferroni adjustments for multiple comparisons were applied to yield an experiment-wise alpha level of .05.|t-test, 2 sided|||TAPES-AES results||||0.85
72553784|NCT03772522|144639566|SUPERIORITY||Cohen's d (effect size)|0.384||||0.428|TWO_SIDED||||||t-test, 2 sided|||Change in score in the immediate intervention group (after receiving the intervention for 6 weeks) compared to that of the delayed intervention group (after receiving no intervention for 6 weeks).||||0.428
72553785|NCT03772522|144639566|SUPERIORITY||Cohen's d (effect size)|-0.46||||0.058|TWO_SIDED||||||t-test, 2 sided|||Comparison of scores at baseline (pre-intervention) and immediately post-intervention.||||0.058
72553786|NCT03772522|144639566|SUPERIORITY||Cohen's d (effect size)|-0.4||||0.095|TWO_SIDED||||||t-test, 2 sided|||Comparison of scores at baseline (pre-intervention) and 3-month post-intervention.||||0.095
72553787|NCT03772522|144639566|SUPERIORITY||Cohen's d (effect size)|-0.73||||0.005|TWO_SIDED||||||t-test, 2 sided|||Comparison of scores at baseline (pre-intervention) and 6-months post-intervention.||||0.005
72553788|NCT03772522|144639566|SUPERIORITY||Cohen's d (effect size)|-0.6||||0.022|TWO_SIDED||||||t-test, 2 sided|||Comparison of scores at baseline (pre-intervention) and 9-months post-intervention.||||0.022
72553789|NCT03772522|144639567|SUPERIORITY||Cohen's d (effect size)|1.792||||0.002|TWO_SIDED||||||t-test, 2 sided|||Change in score in the immediate intervention group (after receiving the intervention for 6 weeks) compared to that of the delayed intervention group (after receiving no intervention for 6 weeks) for the physical component of the CIS.||||0.002
72553790|NCT03772522|144639567|SUPERIORITY||Cohen's d (effect size)|0.047||||0.923|TWO_SIDED||||||t-test, 2 sided|||Change in score in the immediate intervention group (after receiving the intervention for 6 weeks) compared to that of the delayed intervention group (after receiving no intervention for 6 weeks) for the psychological component of the CIS.||||0.923
72553791|NCT03772522|144639567|SUPERIORITY||Cohen's d (effect size)|0.6||||0.18|TWO_SIDED||||||t-test, 2 sided|||Comparison of CIS (physical component) scores at baseline (pre-intervention) and immediately post-intervention.||||0.18
72553792|NCT03772522|144639567|SUPERIORITY||Cohen's d (effect size)|0.2||||0.388|TWO_SIDED||||||t-test, 2 sided|||Comparison of CIS (psychological component) scores at baseline (pre-intervention) and immediately post-intervention.||||0.388
72553793|NCT03772522|144639567|SUPERIORITY||Cohen's d (effect size)|0.52||||0.037|TWO_SIDED||||||t-test, 2 sided|||Comparison of CIS (physical component) scores at baseline (pre-intervention) and 3-months post-intervention.||||0.037
72553794|NCT03772522|144639567|SUPERIORITY||Cohen's d (effect size)|0.09||||0.688|TWO_SIDED||||||t-test, 2 sided|||Comparison of CIS (psychological component) scores at baseline (pre-intervention) and 3-months post-intervention.||||0.688
72553795|NCT03772522|144639567|SUPERIORITY||Cohen's d (effect size)|0.51||||0.038|TWO_SIDED||||||t-test, 2 sided|||Comparison of CIS (physical component) scores at baseline (pre-intervention) and 6-months post-intervention.||||0.038
72553796|NCT03772522|144639567|SUPERIORITY||Cohen's d (effect size)|0.01||||0.956|TWO_SIDED||||||t-test, 2 sided|||Comparison of CIS (psychological component) scores at baseline (pre-intervention) and 6-months post-intervention.||||0.956
72553797|NCT03772522|144639567|SUPERIORITY||Cohen's d (effect size)|0.32||||0.197|TWO_SIDED||||||t-test, 2 sided|||Comparison of CIS (physical component) scores at baseline (pre-intervention) and 9-months post-intervention.||||0.197
72553798|NCT03772522|144639567|SUPERIORITY||Cohen's d (effect size)|-0.07||||0.762|TWO_SIDED||||||t-test, 2 sided|||Comparison of CIS (psychological component) scores at baseline (pre-intervention) and 9-months post-intervention.||||0.762
72553799|NCT03772522|144639568|SUPERIORITY||Cohen's d (effect size)|0.101||||0.834|TWO_SIDED||||||t-test, 2 sided|||Change in score in the immediate intervention group (after receiving the intervention for 6 weeks) compared to that of the delayed intervention group (after receiving no intervention for 6 weeks).||||0.834
72553800|NCT03772522|144639568|SUPERIORITY||Cohen's d (effect size)|0.19||||0.417|TWO_SIDED||||||t-test, 2 sided|||Comparison of SCS scores at baseline (pre-intervention) and immediately post-intervention.||||0.417
72553801|NCT03772522|144639568|SUPERIORITY||Cohen's d (effect size)|0.42||||0.087|TWO_SIDED||||||t-test, 2 sided|||Comparison of SCS scores at baseline (pre-intervention) and 3-months post-intervention.||||0.087
72553802|NCT03772522|144639568|SUPERIORITY||Cohen's d (effect size)|0.33||||0.168|TWO_SIDED||||||t-test, 2 sided|||Comparison of SCS scores at baseline (pre-intervention) and 6-months post-intervention.||||0.168
72553803|NCT03772522|144639568|SUPERIORITY||Cohen's d (effect size)|0.37||||0.133|TWO_SIDED||||||t-test, 2 sided|||Comparison of SCS scores at baseline (pre-intervention) and 9-months post-intervention.||||0.133
72553804|NCT03772522|144639569|SUPERIORITY||Cohen's d (effect size)|1.161||||0.026|TWO_SIDED||||||t-test, 2 sided|||Change in score in the immediate intervention group (after receiving the intervention for 6 weeks) compared to that of the delayed intervention group (after receiving no intervention for 6 weeks).||||0.026
72553805|NCT03772522|144639569|SUPERIORITY||Cohen's d (effect size)|0.62||||0.014|TWO_SIDED||||||t-test, 2 sided|||Comparison of RSS scores at baseline (pre-intervention) and immediately post-intervention.||||0.014
72553806|NCT03772522|144639569|SUPERIORITY||Cohen's d (effect size)|0.29||||0.217|TWO_SIDED||||||t-test, 2 sided|||Comparison of RSS scores at baseline (pre-intervention) and 3-months post-intervention.||||0.217
72553807|NCT03772522|144639569|SUPERIORITY||Cohen's d (effect size)|0.71||||0.006|TWO_SIDED||||||t-test, 2 sided|||Comparison of RSS scores at baseline (pre-intervention) and 6-months post-intervention.||||0.006
72553808|NCT03772522|144639569|SUPERIORITY||Cohen's d (effect size)|0.53||||0.039|TWO_SIDED||||||t-test, 2 sided|||Comparison of RSS scores at baseline (pre-intervention) and 9-months post-intervention.||||0.039
72553809|NCT03697109|144639578|EQUIVALENCE|Log odds is equal to 0 (null hypothesis) vs log odds not equal to 0 (alternative hypothesis).|Odds Ratio (OR)|0.17||||0.0215|TWO_SIDED|95.0|0.04|0.77|||Chi-squared||An odds ratio (OR) \<1 represents lower odds of loss of response under treatment with relacorilant compared with treatment with placebo.|A logistic regression model with logit link function was used in order to detect if there was a significant difference in total number of patients with a loss of response with respect to HTN under treatment with relacorilant compared with treatment with placebo in the RW Phase.||0.77|0.04|0.0215
72553810|NCT00834522|144639596|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Geometric Test/Ref Ratio x 100|103.79||||||90.0|99.4|108.37|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||108.37|99.40|
72553811|NCT00834522|144639597|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Geometric Test/Ref Ratio x 100|104.37||||||90.0|97.04|112.25|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||112.25|97.04|
72369400|NCT02003924|144248729|SUPERIORITY||Hazard Ratio (HR)|0.734||||0.0011|TWO_SIDED|95.0|0.608|0.885||P-value was based on a stratified log-rank test by PSA doubling time (\< 6 months, \>= 6 months) and prior or concurrent use of a bone targeting agent (yes, no) as per interactive voice/web recognition system (IXRS).|Log Rank||HR was based on a Cox regression model (with treatment as the only covariate) stratified by factors defined above, and was relative to placebo with \< 1 favoring Enzalutamide.|To maintain family-wise 2-sided type I error rate at 0.05,parallel testing strategy between OS(with allocated type I error rate 0.03)and remaining key secondary endpoints(time to PSA progression and time to first use of new antineoplastic therapy with allocated type I error rate 0.02)was performed.OS tested at error rate 0.05 when both time to PSA progression and time to first use of new antineoplastic therapy were significant. When either failed to show significance.OS was tested at error 0.03.||0.885|0.608|0.0011
72369401|NCT02003924|144248730|SUPERIORITY||Hazard Ratio (HR)|0.959||||0.6534|TWO_SIDED|95.0|0.801|1.149||P-value was based on a stratified log-rank test by PSA doubling time (\< 6 months, \>= 6 months) and prior or concurrent use of a bone targeting agent (yes, no) as per IXRS.|Log Rank||HR was based on a Cox regression model (with treatment as the only covariate) stratified by factors defined above, and was relative to placebo with \< 1 favoring Enzalutamide.|||1.149|0.801|0.6534
72369402|NCT02003924|144248731|SUPERIORITY||Hazard Ratio (HR)|0.378|||<|0.0001|TWO_SIDED|95.0|0.282|0.507||P-value was based on a stratified log-rank test by PSA doubling time (\< 6 months, \>= 6 months) and prior or concurrent use of a bone targeting agent (yes, no) as per IXRS.|Log Rank||HR was based on a Cox regression model (with treatment as the only covariate) stratified by factors defined above, and was relative to placebo with \< 1 favoring Enzalutamide.|||0.507|0.282|<0.0001
72369403|NCT02003924|144248734|SUPERIORITY||Difference in Response Rate|73.96|||<|0.0001|TWO_SIDED|95.0|70.91|77.02||P-value was based on a Cochran-Mantel-Haenszel mean score test stratified by PSA doubling time (\<6 months, \>= 6 months) and prior concurrent use of a bone targeting agent (yes, no) as per IXRS.|Cochran-Mantel-Haenszel|||Decrease from Baseline \>= 50%||77.02|70.91|<0.0001
72369404|NCT02003924|144248734|SUPERIORITY||Difference in Response Rate|55.52|||<|0.0001|TWO_SIDED|95.0|52.28|58.76||P-value was based on a Cochran-Mantel-Haenszel mean score test stratified by PSA doubling time (\<6 months, \>= 6 months) and prior concurrent use of a bone targeting agent (yes, no) as per IXRS|Cochran-Mantel-Haenszel|||Decrease from Baseline \>= 90%||58.76|52.28|<0.0001
72369405|NCT02003924|144248734|SUPERIORITY||Difference in Response Rate|9.65|||<|0.0001|TWO_SIDED|95.0|7.75|11.54||P-value was based on a Cochran-Mantel-Haenszel mean score test stratified by PSA doubling time (\<6 months, \>= 6 months) and prior concurrent use of a bone targeting agent (yes, no) as per IXRS.|Cochran-Mantel-Haenszel|||Decrease to Undetectable Level||11.54|7.75|<0.0001
72369406|NCT04301193|144248777|OTHER||Correlation - R value|0.93|||<|0.05|TWO_SIDED||||||Regression, Linear|||Using standard techniques for estimating sample size, a Delong's test indicated that a total of 61 samples would be sufcient to detect a 0.2 increase in the AUROC from the null hypothesis 0.5, assuming an alpha level of 5% and 90% power \[12\]. The manuscript was referenced against the STROBE checklist for cohort studies. Descriptive statistics were used to present.||||<0.05
72369407|NCT04301193|144248777|OTHER||Correlation - R value|0.77|||<|0.05|TWO_SIDED||||||Regression, Linear|||||||<0.05
72369408|NCT05767749|144248787|SUPERIORITY||Mean Difference (Final Values)|0.61||||0.93|TWO_SIDED|95.0|-12.8|14.0|||t-test, 2 sided||Direction = (Lidocaine + epinephrine vs Ropivacaine) minus (Lidocaine + epinephrine vs Bupivacaine)|||14.0|-12.8|0.93
72369409|NCT05767749|144248787|SUPERIORITY||Mean Difference (Final Values)|3.73||||0.54|TWO_SIDED|95.0|-8.3|15.8|||t-test, 2 sided||Direction = (Lidocaine + epinephrine vs Ropivacaine) minus (Ropivacaine vs Bupivacaine)|||15.8|-8.3|0.54
72369410|NCT05767749|144248787|SUPERIORITY||Mean Difference (Final Values)|3.12||||0.6|TWO_SIDED|95.0|-8.7|15.0|||t-test, 2 sided||Direction = (Lidocaine + epinephrine vs Bupivacaine) minus (Ropivacaine vs Bupivacaine)|||15.0|-8.7|0.60
72369411|NCT01077050|144248790|SUPERIORITY_OR_OTHER||Sensitivity to Melanoma|96.6|||||ONE_SIDED|95.0|94.2|||The point estimate of the observed sensitivity that is based on generalized linear mixed model is equal to that calculated in the usual manner.|Clopper-Pearson 1-sided||||||94.2|
72369412|NCT01077050|144248790|SUPERIORITY_OR_OTHER||Sensitivity to Basal Cell Carcinoma|100.0|||||TWO_SIDED|95.0|92.6|100.0|||Clopper-Pearson 2-sided|Point estimate of the observed sensitivity for Basal Cell Carcinoma||||100|92.6|
72369413|NCT01077050|144248790|SUPERIORITY_OR_OTHER||Observed sensitivity for squamous cell c|93.3|||||TWO_SIDED|95.0|68.1|99.8|||Clopper-Pearson 2-sided|Point estimate of the observed sensitivity for squamous cell carcinoma||||99.8|68.1|
72369414|NCT01077050|144248790|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|13.0|||<|0.0001|TWO_SIDED|95.0|6.6|25.5|||Mixed Models Analysis|Note that calculating odds ratio adjusting for subjects having multiple lesions, yields similar result.||||25.5|6.6|<0.0001
72369415|NCT00684060|144248792|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.0|STANDARD_ERROR_OF_MEAN|8.6|<|0.05|TWO_SIDED|95.0|-7.05|0.95||Threshold 0.05|t-test, 2 sided|No adjustment for multiple comparisons||Comparison of change in global LVEF in the active group minus change in global LVEF in the control group. 80 percent power based on BOOST results||.95|-7.05|<0.05
72369416|NCT00684060|144248793|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.3|||<|0.05||95.0|0.08|1.17|||Fisher Exact|||comparison of the proportion of events in patients in the active group to those in patients in the control group||1.17|0.08|<0.05
72369417|NCT00684060|144248794|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.2|STANDARD_ERROR_OF_MEAN|17.2|<|0.05|TWO_SIDED|95.0|-9.3|6.8|||t-test, 2 sided|||Comparison of change in the active group minus change in global LVEF in the control group.||6.8|-9.3|<0.05
72369418|NCT00684060|144248795|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.7|STANDARD_ERROR_OF_MEAN|21.8|<|0.05|TWO_SIDED|95.0|-9.5|10.9|||t-test, 2 sided|||Comparison of change in the active group minus change in global LVEF in the control group.||10.9|-9.5|<0.05
72369419|NCT00684060|144248796|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.5|STANDARD_ERROR_OF_MEAN|14.2|<|0.05|TWO_SIDED|95.0|-4.1|9.2|||t-test, 2 sided|||Comparison of change in the active group minus change in the control group.||9.2|-4.1|<0.05
72369420|NCT00684060|144248797|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.5|STANDARD_ERROR_OF_MEAN|17.7|<|0.05||95.0|-9.9|6.9|||t-test, 2 sided|||Comparison of change in the active group minus change in the control group.||6.9|-9.9|<0.05
72553812|NCT00834522|144639598|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Geometric Test/Ref Ratio x 100|104.22||||||90.0|96.9|112.08|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||112.08|96.90|
72369468|NCT00337675|144249106|SUPERIORITY_OR_OTHER_LEGACY||Rate reduction|5.3|STANDARD_ERROR_OF_MEAN|7.3||0.51||95.0|-11.4|19.6||Multiplicity adjustment across regimens was addressed through step-down testing. Daily montelukast versus placebo was tested first; if this comparison was significant, intermittent montelukast versus placebo was tested. The significance level was 5%.|Regression, Poisson|A Poisson regression model containing factors for treatment, age group, and geographic region, and an offset for number of days in study was used.|Rate reduction = (1 - montelukast-adjusted annual rate/placebo-adjusted annual rate) x 100%|The primary hypothesis stated that montelukast (daily regimen, or \[intermittent and daily regimens\]), compared with placebo, results in a decrease in the number of asthma episodes culminating in asthma attack in pediatric patients aged 6 months to 5 years with episodic asthma and treated over 1 year. A sample size of 450 evaluable patients per arm allowed the detection of a difference in rate of 23% with 90% power.||19.6|-11.4|0.510
72369469|NCT00337675|144249106|SUPERIORITY_OR_OTHER_LEGACY||Rate reduction|-1.2|STANDARD_ERROR_OF_MEAN|7.8||0.884||95.0|-19.2|14.0||Multiplicity adjustment across regimens was addressed through step-down testing. Daily montelukast versus placebo was tested first; if this comparison was significant, intermittent montelukast versus placebo was tested. The significance level was 5%.|Regression, Poisson|A Poisson regression model containing factors for treatment, age group, and geographic region, and an offset for number of days in study was used.|Rate reduction = (1 - montelukast-adjusted annual rate/placebo-adjusted annual rate) x 100%|The primary hypothesis stated that montelukast (daily regimen, or \[intermittent and daily regimens\]), compared with placebo, results in a decrease in the number of asthma episodes culminating in asthma attack in pediatric patients aged 6 months to 5 years with episodic asthma and treated over 1 year. A sample size of 450 evaluable patients per arm allowed the detection of a difference in rate of 23% with 90% power.||14.0|-19.2|0.884
72369470|NCT00337675|144249107|SUPERIORITY_OR_OTHER_LEGACY||Least-Squares Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.14||0.176||95.0|-0.46|0.09||Multiplicity adjustment across regimens and across primary and secondary endpoints was addressed through step-down testing. Within the 2 endpoints assessing severity, adjustment for multiplicity was performed using Hochberg's method.|ANOVA|An ANOVA model containing factors for treatment, age group, and geographical region was used.||The secondary hypothesis stated that montelukast (daily regimen, or \[intermittent and daily regimens\]), compared with placebo, results in improvement of respiratory symptoms assessed over 3 days prior to asthma attacks, or assessed over the 12-day treatment period of asthma episodes in pediatric patients aged 6 months to 5 years with episodic asthma and treated over 1 year.||0.09|-0.46|0.176
72369471|NCT00337675|144249107|SUPERIORITY_OR_OTHER_LEGACY||Least-Squares Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.14||0.202||95.0|-0.44|0.09||Multiplicity adjustment across regimens and across primary and secondary endpoints was addressed through step-down testing. Within the 2 endpoints assessing severity, adjustment for multiplicity was performed using Hochberg's method.|ANOVA|An ANOVA model containing factors for treatment, age group, and geographical region was used.||The secondary hypothesis stated that montelukast (daily regimen, or \[intermittent and daily regimens\]), compared with placebo, results in improvement of respiratory symptoms assessed over 3 days prior to asthma attacks, or assessed over the 12-day treatment period of asthma episodes in pediatric patients aged 6 months to 5 years with episodic asthma and treated over 1 year.||0.09|-0.44|0.202
72369472|NCT00337675|144249108|SUPERIORITY_OR_OTHER_LEGACY||Least-Squares Mean Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.06||0.045||95.0|-0.24|0.0||Multiplicity adjustment across regimens and across primary and secondary endpoints was addressed through step-down testing. Within the family of secondary endpoints, adjustment for multiplicity was performed using Hochberg's method.|ANOVA|An ANOVA model containing factors for treatment, age group, and geographical region was used.||The secondary hypothesis stated that montelukast (daily regimen, or \[intermittent and daily regimens\]), compared with placebo, results in improvement of respiratory symptoms assessed over 3 days prior to asthma attacks, or assessed over the 12-day treatment period of asthma episodes in pediatric patients aged 6 months to 5 years with episodic asthma and treated over 1 year.||0.00|-0.24|0.045
72369473|NCT00337675|144249108|SUPERIORITY_OR_OTHER_LEGACY||Least-Squares Mean Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.06||0.061||95.0|-0.23|0.0||Multiplicity adjustment across regimens and across primary and secondary endpoints was addressed through step-down testing. Within the family of secondary endpoints, adjustment for multiplicity was performed using Hochberg's method.|ANOVA|An ANOVA model containing factors for treatment, age group, and geographical region was used.||The secondary hypothesis stated that montelukast (daily regimen, or \[intermittent and daily regimens\]), compared with placebo, results in improvement of respiratory symptoms assessed over 3 days prior to asthma attacks, or assessed over the 12-day treatment period of asthma episodes in pediatric patients aged 6 months to 5 years with episodic asthma and treated over 1 year.||0.00|-0.23|0.061
72369474|NCT01243580|144249121|EQUIVALENCE|Comparing Ortho-Cyclen to Ag200-15|||||<|0.0001|||||||ANOVA|||||||<0.0001
72369475|NCT01243580|144249122|EQUIVALENCE|Comparison of AG200-15 and Ortho-Cyclen|||||<|0.0001|||||||ANOVA|||||||<0.0001
72369476|NCT01243580|144249123|EQUIVALENCE|Comparison of AG200-15 and Ortho-Cyclen||||||0.0001|||||||ANOVA|||||||0.0001
72369477|NCT01243580|144249124|EQUIVALENCE|Comparison of Ortho-Cylen and AG200-15||||||0.0532|||||||ANOVA|||||||0.0532
72369478|NCT01243580|144249125|EQUIVALENCE|Comparison of Ortho-Cyclen and AG200-15||||||0.0009|||||||ANOVA|||||||0.0009
72369479|NCT01243580|144249126|EQUIVALENCE|Comparison of Ortho-Cyclen and AG200-15||||||0.0167|||||||ANOVA|||||||0.0167
72369480|NCT01243580|144249127|EQUIVALENCE|Comparison of Ortho-Cyclen and AG200-15||||||0.0007|||||||ANOVA|||||||0.0007
72369481|NCT01243580|144249128|EQUIVALENCE|Comparison of Ortho-Cyclen and AG200-15||||||0.0175|||||||ANOVA|||||||0.0175
72369482|NCT01243580|144249129|EQUIVALENCE|Comparison of Ortho-Cyclen and AG200-15||||||0.0001|||||||ANOVA|||||||0.0001
72369483|NCT01243580|144249130|EQUIVALENCE|Comparison of Ortho-Cyclen and AG200-15||||||0.0532|||||||ANOVA|||||||0.0532
72369484|NCT03904693|144249139|SUPERIORITY||Geometric Mean Ratio|0.71|||<|0.0001|TWO_SIDED|95.0|0.61|0.82|||ANCOVA|||||0.82|0.61|<0.0001
72369485|NCT03904693|144249139|SUPERIORITY||Geometric Mean Ratio|0.72|||<|0.0001|TWO_SIDED|95.0|0.64|0.8|||ANCOVA|||||0.80|0.64|<0.0001
72553813|NCT03612960|144639599|SUPERIORITY||Mean Difference (Final Values)|0.29|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|95.0|0.14|0.43|||t-test, 2 sided||||The mean percent change in BOLD signal used for this t-test was extracted from a brain cluster with significant group differences in changes in activation over time (voxel p\<.05, cluster p\<.05) identified using a whole-brain, voxel-wise two-way mixed effect ANOVA with FSL software.|0.43|0.14|<.001
72369609|NCT05407064|144249686|SUPERIORITY|Mean change from baseline and mean difference between MM120 dose groups and placebo were estimated using model averaging method (of 3 models). The minimally efficacious dose was defined as a placebo-adjusted improvement of 2.5 points on the HAM-A, with a statistical significance set at an alpha level of 0.05.||||||||||||||||The primary endpoint was evaluated by determining if there was a dose-response relationship between the change from baseline to Week 8 in total HAM-A score and the dose administered using the Multiple Comparison Procedure - Modelling (MCP-Mod) methodology. Several candidate parametric models were assumed, and multiple comparison techniques were used to choose the model(s) likely to present the true underlying dose-response curve.|A test statistic was derived from the data using an ANCOVA model with change from Baseline to Week 8 for the HAM-A Total Score as a response variable, treatment arm and Baseline value of HAM-A Total Score as covariates. The ANCOVA model was repeated for each imputed dataset, which resulted in a set of LS mean estimates for all dose groups and the related covariance matrices. Rubin's rule was used to combine the multiple sets of LS mean estimates and the related covariance matrices to a single set of LS mean estimates of change from Baseline to Week 8 for HAM-A Total Score for all dose groups and the related covariance matrix. The SAS procedure PROC MIANALYZE was used to combine the results from imputed datasets.|||
72369610|NCT05407064|144249687|SUPERIORITY|||||||0.1157|||||||ANCOVA|||Change from Baseline: ANCOVA determination of Least Squares (LS) Mean and difference in LS Mean from placebo||||0.1157
72369611|NCT05407064|144249687|SUPERIORITY|||||||0.663|||||||ANCOVA|||Change from Baseline: ANCOVA determination of Least Squares (LS) Mean and difference in LS Mean from placebo||||0.6630
72369612|NCT05407064|144249687|SUPERIORITY|||||||0.0004|||||||ANCOVA|||Change from Baseline: ANCOVA determination of Least Squares (LS) Mean and difference in LS Mean from placebo||||0.0004
72369613|NCT05407064|144249687|SUPERIORITY|||||||0.01|||||||ANCOVA|||Change from Baseline: ANCOVA determination of Least Squares (LS) Mean and difference in LS Mean from placebo||||0.0100
72369614|NCT05407064|144249688|SUPERIORITY|||||||0.2309|||||||ANCOVA|||Change from Baseline: ANCOVA determination of Least Squares (LS) Mean and difference in LS Mean from placebo||||0.2309
72369615|NCT05407064|144249688|SUPERIORITY|||||||0.7218|||||||ANCOVA|||Change from Baseline: ANCOVA determination of Least Squares (LS) Mean and difference in LS Mean from placebo||||0.7218
72369616|NCT05407064|144249688|SUPERIORITY|||||||0.0637|||||||ANCOVA|||Change from Baseline: ANCOVA determination of Least Squares (LS) Mean and difference in LS Mean from placebo||||0.0637
72369617|NCT05407064|144249688|SUPERIORITY|||||||0.0216|||||||ANCOVA|||Change from Baseline: ANCOVA determination of Least Squares (LS) Mean and difference in LS Mean from placebo||||0.0216
72369618|NCT05407064|144249689|SUPERIORITY|||||||0.1006|||||||ANCOVA|||Change from Baseline: ANCOVA determination of Least Squares (LS) Mean and difference in LS Mean from placebo||||0.1006
72369619|NCT05407064|144249689|SUPERIORITY|||||||0.2225|||||||ANCOVA|||Change from Baseline: ANCOVA determination of Least Squares (LS) Mean and difference in LS Mean from placebo||||0.2225
72369620|NCT05407064|144249689|SUPERIORITY|||||||0.0025|||||||ANCOVA|||Change from Baseline: ANCOVA determination of Least Squares (LS) Mean and difference in LS Mean from placebo||||0.0025
72369621|NCT05407064|144249689|SUPERIORITY|||||||0.0042|||||||ANCOVA|||Change from Baseline: ANCOVA determination of Least Squares (LS) Mean and difference in LS Mean from placebo||||0.0042
72369622|NCT05407064|144249690|SUPERIORITY|||||||0.6258|||||||t-test, 2 sided|||Change from baseline in total MADRS scores determined by the difference in means and difference between treatment and placebo (p-value determined from two-sample t-test)||||0.6258
72369623|NCT05407064|144249690|SUPERIORITY|||||||0.95|||||||t-test, 2 sided|||Change from baseline in total MADRS scores determined by the difference in means and difference between treatment and placebo (p-value determined from two-sample t-test)||||0.95
72369624|NCT05407064|144249690|SUPERIORITY|||||||0.0174|||||||t-test, 2 sided|||Change from baseline in total MADRS scores determined by the difference in means and difference between treatment and placebo (p-value determined from two-sample t-test)||||0.0174
72369625|NCT05407064|144249690|SUPERIORITY|||||||0.0206|||||||t-test, 2 sided|||Change from baseline in total MADRS scores determined by the difference in means and difference between treatment and placebo (p-value determined from two-sample t-test)||||0.0206
72369626|NCT05407064|144249691|SUPERIORITY|||||||0.5538|||||||t-test, 2 sided|||Assessment of change from baseline in total MADRS scores determined by the difference in means and difference between treatment and placebo (p-value determined from two-sample t-test)||||0.5538
72369627|NCT05407064|144249691|SUPERIORITY|||||||0.665|||||||t-test, 2 sided|||Change from baseline in total MADRS scores determined by the difference in means and difference between treatment and placebo (p-value determined from two-sample t-test)||||0.6650
72369628|NCT05407064|144249691|SUPERIORITY|||||||0.019|||||||t-test, 2 sided|||Change from baseline in total MADRS scores determined by the difference in means and difference between treatment and placebo (p-value determined from two-sample t-test)||||0.0190
72369629|NCT05407064|144249691|SUPERIORITY|||||||0.0034|||||||t-test, 2 sided|||Change from baseline in total MADRS scores determined by the difference in means and difference between treatment and placebo (p-value determined from two-sample t-test)||||0.0034
72369630|NCT05407064|144249692|SUPERIORITY|||||||0.7236|||||||t-test, 2 sided|||Assessment of change from baseline in total CGI-S scores determined by the difference in means and difference between treatment and placebo (p-value determined from two-sample t-test)||||0.7236
72369631|NCT05407064|144249692|SUPERIORITY|||||||0.9738|||||||t-test, 2 sided|||Assessment of change from baseline in total CGI-S scores determined by the difference in means and difference between treatment and placebo (p-value determined from two-sample t-test)||||0.9738
72369632|NCT05407064|144249692|SUPERIORITY|||||||0.0338|||||||t-test, 2 sided|||Assessment of change from baseline in total CGI-S scores determined by the difference in means and difference between treatment and placebo (p-value determined from two-sample t-test)||||0.0338
72369633|NCT05407064|144249692|SUPERIORITY|||||||0.0282|||||||t-test, 2 sided|||Assessment of change from baseline in total CGI-S scores determined by the difference in means and difference between treatment and placebo (p-value determined from two-sample t-test)||||0.0282
72369634|NCT05407064|144249693|SUPERIORITY|||||||0.9302|||||||t-test, 2 sided|||Change from baseline in total MADRS scores determined by the difference in means and difference between treatment and placebo (p-value determined from two-sample t-test).||||0.9302
72369635|NCT05407064|144249693|SUPERIORITY|||||||0.6763|||||||t-test, 2 sided|||Change from baseline in total MADRS scores determined by the difference in means and difference between treatment and placebo (p-value determined from two-sample t-test).||||0.6763
72369836|NCT04881942|144250145|EQUIVALENCE|"Null Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is equal to 0.~Alternate Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is not equal to 0."|Mean Difference (Net)|168.83|||<|0.0001|TWO_SIDED|95.0|95.17|242.5|||ANCOVA||Mean value is sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham).|"Null Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is equal to 0.~Alternate Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is not equal to 0."||242.50|95.17|<.0001
72369837|NCT04881942|144250145|EQUIVALENCE|"Null Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is equal to 0.~Alternate Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is not equal to 0."|Mean Difference (Net)|182.65|||<|0.0001|TWO_SIDED|95.0|108.63|256.67|||ANCOVA||Mean value is sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham).|"Null Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is equal to 0.~Alternate Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is not equal to 0."||256.67|108.63|<.0001
72369838|NCT04881942|144250148|EQUIVALENCE|"Null Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is equal to 0.~Alternate Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is not equal to 0."|Mean Difference (Net)|5972.3|||<|0.0001|TWO_SIDED|95.0|4191.1|7753.6|||ANCOVA||Mean value is sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham).|"Null Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is equal to 0.~Alternate Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is not equal to 0."||7753.6|4191.1|<.0001
72369839|NCT04881942|144250148|EQUIVALENCE|"Null Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is equal to 0.~Alternate Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is not equal to 0."|Mean Difference (Net)|6099.5|||<|0.0001|TWO_SIDED|95.0|4317.8|7881.2|||ANCOVA||Mean value is sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham).|"Null Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is equal to 0.~Alternate Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is not equal to 0."||7881.2|4317.8|<.0001
72369840|NCT04881942|144250148|EQUIVALENCE|"Null Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is equal to 0.~Alternate Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is not equal to 0."|Mean Difference (Net)|6484.7|||<|0.0001|TWO_SIDED|95.0|4701.7|8267.6|||ANCOVA||Mean value is sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham).|"Null Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is equal to 0.~Alternate Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is not equal to 0."||8267.6|4701.7|<.0001
72369841|NCT04881942|144250148|EQUIVALENCE|"Null Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is equal to 0.~Alternate Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is not equal to 0."|Mean Difference (Net)|5366.8|||<|0.0001|TWO_SIDED|95.0|3575.9|7157.7|||ANCOVA||Mean value is sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham).|"Null Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is equal to 0.~Alternate Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is not equal to 0."||7157.7|3575.9|<.0001
72369842|NCT04881942|144250151|EQUIVALENCE|"Null Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is equal to 0.~Alternate Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is not equal to 0."|Mean Difference (Net)|0.17||||0.915|TWO_SIDED|95.0|-2.92|3.25|||ANCOVA||Mean value is sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is not equal to 0.|"Null Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is equal to 0.~Alternate Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is not equal to 0."||3.25|-2.92|0.9150
72369843|NCT04881942|144250151|EQUIVALENCE|"Null Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is equal to 0.~Alternate Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is not equal to 0."|Mean Difference (Net)|0.35||||0.8217|TWO_SIDED|95.0|-2.7|3.4|||ANCOVA||Mean value is sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham).|"Null Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is equal to 0.~Alternate Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is not equal to 0."||3.40|-2.70|0.8217
72553814|NCT03612960|144639600|SUPERIORITY||Mean Difference (Final Values)|-8.38|STANDARD_ERROR_OF_MEAN|4.33||0.063|TWO_SIDED|95.0|-17.24|0.48|||t-test, 2 sided|||||0.48|-17.24|.063
72553815|NCT03612960|144639601|SUPERIORITY||Mean Difference (Final Values)|-1.38|STANDARD_ERROR_OF_MEAN|9.86||0.89|TWO_SIDED|95.0|-21.57|18.82|||t-test, 2 sided|||||18.82|-21.57|0.890
72553864|NCT01980771|144639743|SUPERIORITY||Odds Ratio (OR)|1.58||||0.04|TWO_SIDED|95.0|1.03|2.43|||Mixed Models Analysis|||||2.43|1.03|0.04
72369844|NCT04881942|144250151|EQUIVALENCE|"Null Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is equal to 0.~Alternate Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is not equal to 0."|Mean Difference (Net)|21.11|||<|0.0001|TWO_SIDED|95.0|18.06|24.16|||ANCOVA||Mean value is sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is not equal to 0.|"Null Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is equal to 0.~Alternate Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is not equal to 0."||24.16|18.06|<.0001
72369845|NCT04881942|144250151|EQUIVALENCE|"Null Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is equal to 0.~Alternate Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is not equal to 0."|Mean Difference (Net)|31.01|||<|0.0001|TWO_SIDED|95.0|27.91|34.12|||ANCOVA||Mean value is sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham).|"Null Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is equal to 0.~Alternate Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is not equal to 0."||34.12|27.91|<.0001
72369846|NCT04881942|144250154|EQUIVALENCE|"Null Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is equal to 0.~Alternate Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is not equal to 0."|Mean Difference (Net)|1678.4||||0.0031|TWO_SIDED|95.0|592.14|2764.6|||ANCOVA||Mean value is sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham).|"Null Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is equal to 0.~Alternate Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is not equal to 0."||2764.6|592.14|.0031
72369847|NCT04881942|144250154|EQUIVALENCE|"Null Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is equal to 0.~Alternate Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is not equal to 0."|Mean Difference (Net)|1199.7||||0.031|TWO_SIDED|95.0|113.74|2285.7|||ANCOVA||Mean value is sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham).|"Null Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is equal to 0.~Alternate Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is not equal to 0."||2285.7|113.74|.0310
72369848|NCT04881942|144250154|EQUIVALENCE|"Null Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is equal to 0.~Alternate Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is not equal to 0."|Mean Difference (Net)|3354.5|||<|0.0001|TWO_SIDED|95.0|2266.6|4442.3|||ANCOVA||Mean value is sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham).|"Null Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is equal to 0.~Alternate Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is not equal to 0."||4442.3|2266.6|<.0001
72369849|NCT04881942|144250154|EQUIVALENCE|"Null Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is equal to 0.~Alternate Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is not equal to 0."|Mean Difference (Net)|2511.0|||<|0.0001|TWO_SIDED|95.0|1416.1|3605.9|||ANCOVA||Mean value is sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham).|"Null Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is equal to 0.~Alternate Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is not equal to 0."||3605.9|1416.1|<.0001
72369850|NCT04881942|144250157|EQUIVALENCE|"Null Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is equal to 0.~Alternate Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is not equal to 0."|Mean Difference (Net)|0.25||||0.0002|TWO_SIDED|95.0|0.12|0.38|||ANCOVA||Mean value is sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is not equal to 0.|"Null Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is equal to 0.~Alternate Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is not equal to 0."||0.38|0.12|.0002
72369851|NCT04881942|144250157|EQUIVALENCE|"Null Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is equal to 0.~Alternate Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is not equal to 0."|Mean Difference (Net)|0.25||||0.0003|TWO_SIDED|95.0|0.12|0.38|||ANCOVA||Mean value is sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham).|"Null Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is equal to 0.~Alternate Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is not equal to 0."||0.38|0.12|0.0003
72553865|NCT05342597|144639788|OTHER|Estimated difference in least squares means and corresponding 90%CI of log-transformed PK parameters were back transformed to obtain the estimate and CI of the geometric mean ratio of each meal condition to the fasted state.|LS Mean Ratio|1.025|||||TWO_SIDED|90.0|0.931|1.128|||ANOVA|||PK parameters of unchanged edaravone were analyzed for the assessments of food effect on PK.||1.128|0.931|
72369852|NCT04881942|144250157|EQUIVALENCE|"Null Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is equal to 0.~Alternate Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is not equal to 0."|Mean Difference (Net)|0.34|||<|0.0001|TWO_SIDED|95.0|0.21|0.47|||ANCOVA||Mean value is sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham).|"Null Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is equal to 0.~Alternate Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is not equal to 0."||0.47|0.21|<.0001
72369853|NCT04881942|144250157|EQUIVALENCE|"Null Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is equal to 0.~Alternate Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is not equal to 0."|Mean Difference (Net)|0.3|||<|0.0001|TWO_SIDED|95.0|0.17|0.43|||ANCOVA||Mean value is sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham).|"Null Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is equal to 0.~Alternate Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is not equal to 0."||0.43|0.17|<.0001
72369854|NCT04881942|144250164|EQUIVALENCE|Null Hypothesis: Mean cartridge weight change is equal to 0. Alternate Hypothesis: Mean cartridge weight change is not equal to 0.|Mean Difference (Final Values)|0.035|||<|0.0001|TWO_SIDED|95.0|0.031|0.039|||ANOVA|||Null Hypothesis: Mean cartridge weight change is equal to 0. Alternate Hypothesis: Mean cartridge weight change is not equal to 0.||0.039|0.031|<.0001
72369855|NCT04881942|144250164|EQUIVALENCE|Null Hypothesis: Mean cartridge weight change is equal to 0. Alternate Hypothesis: Mean cartridge weight change is not equal to 0.|Mean Difference (Net)|0.034|||<|0.0001|TWO_SIDED|95.0|0.03|0.038|||ANOVA|||Null Hypothesis: Mean cartridge weight change is equal to 0. Alternate Hypothesis: Mean cartridge weight change is not equal to 0.||0.038|0.030|<.0001
72369856|NCT04881942|144250164|EQUIVALENCE|Null Hypothesis: Mean cartridge weight change is equal to 0. Alternate Hypothesis: Mean cartridge weight change is not equal to 0.|Mean Difference (Net)|0.04|||<|0.0001|TWO_SIDED|95.0|0.036|0.044|||ANOVA|||Null Hypothesis: Mean cartridge weight change is equal to 0. Alternate Hypothesis: Mean cartridge weight change is not equal to 0.||0.044|0.036|<.0001
72369857|NCT04881942|144250164|EQUIVALENCE|Null Hypothesis: Mean cartridge weight change is equal to 0. Alternate Hypothesis: Mean cartridge weight change is not equal to 0.|Mean Difference (Net)|0.037|||<|0.0001|TWO_SIDED|95.0|0.033|0.041|||ANOVA|||Null Hypothesis: Mean cartridge weight change is equal to 0. Alternate Hypothesis: Mean cartridge weight change is not equal to 0.||0.041|0.033|<.0001
72369858|NCT04881942|144250165|EQUIVALENCE|Null Hypothesis: Mean cartridge weight change is equal to 0. Alternate Hypothesis: Mean cartridge weight change is not equal to 0.|Mean Difference (Net)|0.036|||<|0.0001|TWO_SIDED|95.0|0.031|0.04|||ANOVA|||Null Hypothesis: Mean cartridge weight change is equal to 0. Alternate Hypothesis: Mean cartridge weight change is not equal to 0.||0.040|0.031|<.0001
72369859|NCT04881942|144250165|EQUIVALENCE|Null Hypothesis: Mean cartridge weight change is equal to 0. Alternate Hypothesis: Mean cartridge weight change is not equal to 0.|Mean Difference (Net)|0.036|||<|0.0001|TWO_SIDED|95.0|0.032|0.041|||ANOVA|||Null Hypothesis: Mean cartridge weight change is equal to 0. Alternate Hypothesis: Mean cartridge weight change is not equal to 0.||0.041|0.032|<.0001
72369860|NCT04881942|144250165|EQUIVALENCE|Null Hypothesis: Mean cartridge weight change is equal to 0. Alternate Hypothesis: Mean cartridge weight change is not equal to 0.|Mean Difference (Net)|0.041|||<|0.0001|TWO_SIDED|95.0|0.037|0.046|||ANOVA|||Null Hypothesis: Mean cartridge weight change is equal to 0. Alternate Hypothesis: Mean cartridge weight change is not equal to 0.||0.046|0.037|<.0001
72369861|NCT04881942|144250165|EQUIVALENCE|Null Hypothesis: Mean cartridge weight change is equal to 0. Alternate Hypothesis: Mean cartridge weight change is not equal to 0.|Mean Difference (Net)|0.038|||<|0.0001|TWO_SIDED|95.0|0.033|0.042|||ANOVA|||Null Hypothesis: Mean cartridge weight change is equal to 0. Alternate Hypothesis: Mean cartridge weight change is not equal to 0.||0.042|0.033|<.0001
72369862|NCT04881942|144250166|EQUIVALENCE|Null Hypothesis: Mean cartridge weight change is equal to 0. Alternate Hypothesis: Mean cartridge weight change is not equal to 0.|Mean Difference (Net)|0.536|||<|0.0001|TWO_SIDED|95.0|0.407|0.665|||ANCOVA||LSM calculated from mixed models. Each model includes fixed effect terms for product, period and sequence.|Null Hypothesis: Mean cartridge weight change is equal to 0. Alternate Hypothesis: Mean cartridge weight change is not equal to 0.||0.665|0.407|<.0001
72369863|NCT04881942|144250166|EQUIVALENCE|Null Hypothesis: Mean cartridge weight change is equal to 0. Alternate Hypothesis: Mean cartridge weight change is not equal to 0.|Mean Difference (Net)|0.408|||<|0.0001|TWO_SIDED|95.0|0.28|0.537|||ANCOVA||LSM calculated from mixed models. Each model includes fixed effect terms for product, period and sequence.|Null Hypothesis: Mean cartridge weight change is equal to 0. Alternate Hypothesis: Mean cartridge weight change is not equal to 0.||0.537|0.280|<.0001
72369864|NCT04881942|144250166|EQUIVALENCE|Null Hypothesis: Mean cartridge weight change is equal to 0. Alternate Hypothesis: Mean cartridge weight change is not equal to 0.|Mean Difference (Net)|0.468|||<|0.0001|TWO_SIDED|95.0|0.339|0.596|||ANCOVA||LSM calculated from mixed models. Each model includes fixed effect terms for product, period and sequence.|Null Hypothesis: Mean cartridge weight change is equal to 0. Alternate Hypothesis: Mean cartridge weight change is not equal to 0.||0.596|0.339|<.0001
72369865|NCT04881942|144250166|EQUIVALENCE|Null Hypothesis: Mean cartridge weight change is equal to 0. Alternate Hypothesis: Mean cartridge weight change is not equal to 0.|Mean Difference (Net)|0.43|||<|0.0001|TWO_SIDED|95.0|0.301|0.559|||ANCOVA||LSM calculated from mixed models. Each model includes fixed effect terms for product, period and sequence.|Null Hypothesis: Mean cartridge weight change is equal to 0. Alternate Hypothesis: Mean cartridge weight change is not equal to 0.||0.559|0.301|<.0001
72369866|NCT04881942|144250168|EQUIVALENCE|Null Hypothesis: Mean Puff Count is equal to 0 Alternative Hypothesis: Mean Puff Count is not equal to 0|Mean Difference (Final Values)|277.79|||<|0.0001|TWO_SIDED|95.0|213.62|341.96|||ANCOVA||LSM calculated from mixed models. Each model includes fixed effect terms for product, period and sequence.|Null Hypothesis: Mean Puff Count is equal to 0 Alternative Hypothesis: Mean Puff Count is not equal to 0||341.96|213.62|<.0001
72370001|NCT00505778|144250420|NON_INFERIORITY_OR_EQUIVALENCE|To establish non-inferiority for primary efficacy variable at 2-sided upper confidence bound of 95% with 90% power, 442 patients per treatment group were required to be analyzable for primary efficacy analysis. Assuming 10% enrolled would not be analyzable, 1000 patients would be enrolled. If the 95% confidence interval's upper bound interval for the difference between the Asacol BID and Asacol QD group is \<10%, then non-inferiority of Asacol QD is claimed.|BID-QD Difference in Remission Rates|0.0||||0.977|TWO_SIDED|95.0|-4.6|4.7|||Cochran-Mantel-Haenszel|Stratified by prior Asacol dose Category||Assumed true remission rate is 70% with no difference in remission rates between QD and BID dosing.The non-inferiority margin used in hypothesis testing was set to 10%.||4.7|-4.6|0.9770
72370002|NCT00505778|144250421|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.17||||0.4726|TWO_SIDED|95.0|0.762|1.796|||Log Rank|Stratified by prior Asacol dose Category||||1.796|0.762|0.4726
72370003|NCT00505778|144250422|SUPERIORITY_OR_OTHER||Difference BID-QD in Least Square Mean|-0.45||||0.1753|TWO_SIDED|95.0|-1.09|0.2|||ANOVA|ANOVA with prior Asacol dose category as factor.||||0.20|-1.09|0.1753
72370004|NCT00505778|144250423|NON_INFERIORITY_OR_EQUIVALENCE|To establish non-inferiority for primary efficacy variable at 2-sided upper confidence bound of 95% with 90% power, 442 patients per treatment group were required to be analyzable for primary efficacy analysis. Assuming 10% enrolled would not be analyzable, 1000 patients would be enrolled. If the 95% confidence interval's upper bound interval for the difference between the Asacol BID and Asacol QD group is \<10%, then non-inferiority of Asacol QD is claimed.|Difference BID-QD Remission Rates|3.6||||0.1557|TWO_SIDED|95.0|-1.3|8.5|||Cochran-Mantel-Haenszel|Stratified by prior Asacol dose Category||Assumed true remission rate is 70% with no difference in remission rates between QD and BID dosing.The non-inferiority margin used in hypothesis testing was set to 10%.||8.5|-1.3|0.1557
72370005|NCT05367492|144250425|SUPERIORITY||Odds Ratio (OR)|6.5|||<|0.001|TWO_SIDED|95.0|3.0|14.1|||Regression, Logistic|Model fit to data from varenicline and placebo groups only, adjusted for sex and baseline E-cigarette Dependence Inventory score.|Adjusted odds ratio comparing varenicline (numerator) versus placebo (denominator).|||14.1|3.0|<0.001
72370006|NCT05367492|144250425|SUPERIORITY||||||<|0.001||||||The p-value is adjusted for multiple comparisons using per Benjamini \& Hochberg (1995) across the primary outcome measure. Effects were deemed significant for p\<0.05.|Regression, Logistic|Omnibus tests for any difference in abstinence rates across study groups, based on χ² Wald statistic and adjusted for sex and baseline ECDI score.||||||<0.001
72370007|NCT05367492|144250426|SUPERIORITY||Odds Ratio (OR)|6.1|||<|0.001|TWO_SIDED|95.0|3.1|12.3||Benjamini-Hochberg multiplicity correction applied to p-values reported across family of five secondary analysis results (Varenicline vs Placebo comparisons of secondary abstinence outcomes, and omnibus tests of all three abstinence outcomes).|Regression, Logistic|Model fit to data from varenicline and placebo groups only, adjusted for sex and baseline E-cigarette Dependence Inventory score.|Adjusted odds ratio comparing varenicline (numerator) versus placebo (denominator).|||12.3|3.1|<0.001
72370008|NCT05367492|144250426|SUPERIORITY||||||<|0.001||||||Benjamini-Hochberg multiplicity correction applied to p-values reported across family of five secondary analysis results (Varenicline vs Placebo comparisons of secondary abstinence outcomes, and omnibus tests of all three abstinence outcomes).|Regression, Logistic|Omnibus tests for any difference in abstinence rates across study groups, based on χ² Wald statistic and adjusted for sex and baseline ECDI score.||||||<0.001
72370009|NCT05367492|144250427|SUPERIORITY||Odds Ratio (OR)|6.0||||0.001|TWO_SIDED|95.0|2.1|16.9||Benjamini-Hochberg multiplicity correction applied to p-values reported across family of five secondary analysis results (Varenicline vs Placebo comparisons of secondary abstinence outcomes, and omnibus tests of all three abstinence outcomes).|Regression, Logistic|Model fit to data from varenicline and placebo groups only, adjusted for sex and baseline E-cigarette Dependence Inventory score.|Adjusted odds ratio comparing varenicline (numerator) versus placebo (denominator).|||16.9|2.1|0.001
72370010|NCT05367492|144250427|SUPERIORITY||||||<|0.001||||||Benjamini-Hochberg multiplicity correction applied to p-values reported across family of five secondary analysis results (Varenicline vs Placebo comparisons of secondary abstinence outcomes, and omnibus tests of all three abstinence outcomes).|Regression, Logistic|Omnibus tests for any difference in abstinence rates across study groups, based on χ² Wald statistic and adjusted for sex and baseline ECDI score.||||||<0.001
72370011|NCT05367492|144250428|SUPERIORITY||Mean Difference (Net)|-1.88||||0.001|TWO_SIDED|95.0|-2.93|-0.83||Benjamini-Hochberg multiplicity correction applied to p-values reported across family of three secondary analysis results (Varenicline vs Placebo comparisons of secondary inventory outcomes).|Regression, Linear|Models fit to data from varenicline and placebo groups only using GEE, adjusted for sex, baseline ECDI and outcome score, and quadratic trend of time.|Adjusted mean difference comparing varenicline versus placebo. Negative indicates larger mean in placebo.|||-0.83|-2.93|0.001
72370012|NCT05367492|144250428|SUPERIORITY||||||<|0.001||||||Benjamini-Hochberg multiplicity correction applied to p-values reported across family of three secondary analysis results (Varenicline vs Placebo comparisons of secondary inventory outcomes).|Regression, Linear|Models fit using GEE, adjusted for sex, baseline ECDI and outcome score, and quadratic time. Omnibus Wald test of any difference across study group.||||||<0.001
72370013|NCT05367492|144250429|SUPERIORITY||Mean Difference (Net)|-6.76|||<|0.001|TWO_SIDED|95.0|-9.08|-4.45||Benjamini-Hochberg multiplicity correction applied to p-values reported across family of three secondary analysis results (Varenicline vs Placebo comparisons of secondary inventory outcomes).|Regression, Linear|Models fit to data from varenicline and placebo groups only using GEE, adjusted for sex, baseline ECDI and outcome score, and quadratic trend of time.|Adjusted mean difference comparing varenicline versus placebo. Negative indicates larger mean in placebo.|||-4.45|-9.08|<0.001
72370014|NCT05367492|144250429|SUPERIORITY||||||<|0.001||||||Benjamini-Hochberg multiplicity correction applied to p-values reported across family of three secondary analysis results (Omnibus tests of secondary inventory outcomes).|Regression, Linear|Models fit using GEE, adjusted for sex, baseline ECDI and outcome score, and quadratic time. Omnibus Wald test of any difference across study groups.||||||<0.001
72553866|NCT05342597|144639788|OTHER|Estimated difference in least squares means and corresponding 90%CI of log-transformed PK parameters were back transformed to obtain the estimate and CI of the geometric mean ratio of each meal condition to the fasted state.|LS Mean Ratio|0.959|||||TWO_SIDED|90.0|0.871|1.056|||ANOVA|||PK parameters of unchanged edaravone were analyzed for the assessments of food effect on PK.||1.056|0.871|
72553820|NCT00272779|144639618|SUPERIORITY_OR_OTHER||Difference Estimate|1.7|||||TWO_SIDED|95.0|-3.8|7.1||Assuming 70% response rate (70% of participants remain on treatment for 48 wks and HIV RNA \<50 copies/mL) on both regimens, sample size of 882 randomized participants (441/regimen) provided 90% power to demonstrate ATV/RTV is non-inferior to LPV/RTV|Cochran-Mantel-Haenszel|The ATV/RTV regimen was deemed to be non-inferior to the lopinavir/ritonavir regimen if the lower CI for the difference in proportions \> -10%.||Treatment regimens compared by calculation of the difference in proportions (atazanavir/ritonavir- lopinavir/ritonavir) and 95% CI based on stratified normal approximation.Analyses were stratified by the same strata as randomization-HIV RNA level at enrollment and geographic region.The proportion of participants with HIV RNA below 50 copies/mL was computed within each stratum, and combined by use of a weighted average with weights proportional to stratum size:Cochran-Mantel-Haenszel weighting||7.1|-3.8|
72553821|NCT00272779|144639619|SUPERIORITY_OR_OTHER||Difference Estimate|3.3|||||TWO_SIDED|95.0|-1.5|8.1|||Cochran-Mantel-Haenszel|||Treatment regimens were compared by calculation of the difference in proportions (ATV/RTV-LPV/RTV) and 95% CI based on a stratified normal approximation. Analyses were stratified by the same strata as randomization-ie, HIV RNA level at enrollment and geographic region. The proportion of participants with HIV RNA below 400 copies per mL was computed within each stratum, and combined by use of a weighted average with weights proportional to stratum size (Cochran-Mantel-Haenszel weighting).||8.1|-1.5|
72553822|NCT00272779|144639622|SUPERIORITY_OR_OTHER||Difference Estimate|-16.4|||||TWO_SIDED|95.0|-35.9|3.1|||95% CI comparison of difference|||Mean changes in CD4 cell counts from baseline at week 48 were compared between treatment regimens with 95% CIs based on stratified normal approximations and observed values.||3.1|-35.9|
72553823|NCT00272779|144639644|SUPERIORITY_OR_OTHER||Difference Estimate|6.1|||||TWO_SIDED|95.0|0.3|12.0||Assuming 70% response rate (70% of participants remain on treatment for 96 wks and HIV RNA \<50 copies/mL) on both regimens, sample size of 882 randomized participants (441/regimen) provided 90% power to demonstrate ATV/RTV is non-inferior to LPV/RTV|Cochran-Mantel-Haenszel|The ATV/RTV regimen was deemed to be non-inferior to the lopinavir/ritonavir regimen if the lower CI for the difference in proportions \> -10%.||Treatment regimens compared by calculation of the difference in proportions (atazanavir/ritonavir- lopinavir/ritonavir) and 95% CI based on stratified normal approximation.Analyses were stratified by the same strata as randomization-HIV RNA level at enrollment and geographic region.The proportion of participants with HIV RNA below 50 copies/mL was computed within each stratum, and combined by use of a weighted average with weights proportional to stratum size:Cochran-Mantel-Haenszel weighting||12.0|0.3|
72553824|NCT00272779|144639645|SUPERIORITY_OR_OTHER||Difference Estimate|5.1|||||TWO_SIDED|95.0|-0.4|10.6|||Cochran-Mantel-Haenszel|||Treatment regimens were compared by calculation of the difference in proportions (ATV/RTV-LPV/RTV) and 95% CI based on a stratified normal approximation. Analyses were stratified by the same strata as randomization-ie, HIV RNA level at enrollment and geographic region. The proportion of participants with HIV RNA below 400 copies per mL was computed within each stratum, and combined by use of a weighted average with weights proportional to stratum size (Cochran-Mantel-Haenszel weighting).||10.6|-0.4|
72553825|NCT00272779|144639647|SUPERIORITY_OR_OTHER||Difference Estimate|-21.2|||||TWO_SIDED|95.0|-43.3|0.9|||95% CI comparison of difference|||Mean changes in CD4 cell counts from baseline at week 48 were compared between treatment regimens with 95% CIs based on stratified normal approximations and observed values.||0.9|-43.3|
72553826|NCT00272779|144639663|SUPERIORITY_OR_OTHER||point estimate|0.761|||||TWO_SIDED|90.0|0.507|1.142|||ANOVA||Point estimates and 90% confidence intervals (CIs) for differences between treatment regimens were calculated on the log scale, and were exponentiated to obtain estimates for ratios of geometric means on the original scale.|||1.142|0.507|
72553827|NCT00272779|144639664|SUPERIORITY_OR_OTHER||point estimate|1.46|||||TWO_SIDED|90.0|1.005|2.121|||ANOVA||Point estimates and 90% CIs for differences between treatment regimens were calculated on the log scale, and were exponentiated to obtain estimates for ratios of geometric means on the original scale.|||2.121|1.005|
72553828|NCT00272779|144639665|SUPERIORITY_OR_OTHER||point estimate|0.839|||||TWO_SIDED|90.0|0.612|1.151|||ANOVA||Point estimates and 90% CIs for differences between treatment regimens were calculated on the log scale, and were exponentiated to obtain estimates for ratios of geometric means on the original scale.|||1.151|0.612|
72553829|NCT00272779|144639666|SUPERIORITY_OR_OTHER||point estimate|0.282|||||TWO_SIDED|90.0|0.181|0.439|||ANOVA||Point estimates and 90% CIs for differences between treatment regimens were calculated on the log scale, and were exponentiated to obtain estimates for ratios of geometric means on the original scale.|||0.439|0.181|
72553830|NCT00272779|144639667|SUPERIORITY_OR_OTHER||point estimate|0.925|||||TWO_SIDED|90.0|0.699|1.223|||ANOVA||Point estimates and 90% CIs for differences between treatment regimens were calculated on the log scale, and were exponentiated to obtain estimates for ratios of geometric means on the original scale.|||1.223|0.699|
72553831|NCT00272779|144639668|SUPERIORITY_OR_OTHER||point estimate|0.853|||||TWO_SIDED|90.0|0.626|1.161|||ANOVA||Point estimates and 90% CIs for differences between treatment regimens were calculated on the log scale, and were exponentiated to obtain estimates for ratios of geometric means on the original scale.|||1.161|0.626|
72553832|NCT00272779|144639669|SUPERIORITY_OR_OTHER||point estimate|0.89|||||TWO_SIDED|90.0|0.689|1.151|||ANOVA||Point estimates and 90% CIs for differences between treatment regimens were calculated on the log scale, and were exponentiated to obtain estimates for ratios of geometric means on the original scale.|||1.151|0.689|
72553833|NCT00272779|144639693|SUPERIORITY_OR_OTHER|||||||0.0847||95.0||||The explanatory variables in the model include treatment, genotype, time, and their interaction effects as fixed effects and the spatial exponential with respect to time from baseline was used to model the covariance structure of repeated measures.|linear mixed effect model|The FDR multiple testing adjustment was used to adjust p-values for the number of SNPs being tested (only SNPs with FDR-adj p-values \<0.2 reported)||Null Hypothesis: There is no association between the mean change from baseline in fasting non-HDL cholesterol (phenotype) and the RETN\_097 genotypes. A single SNP association analysis was conducted using the linear mixed effect model for repeated measures (baseline, week 48 and 96) to test the overall genotype effect (i.e. an omnibus test on both the marginal genotype effect and the genotype-by-treatment interaction effect). Number of participants with RETN\_097 reported in Outcome Measure 16.||||0.0847
72553867|NCT05342597|144639788|OTHER|Estimated difference in least squares means and corresponding 90%CI of log-transformed PK parameters were back transformed to obtain the estimate and CI of the geometric mean ratio of each meal condition to the fasted state.|LS Mean Ratio|0.91|||||TWO_SIDED|90.0|0.827|1.002|||ANOVA|||PK parameters of unchanged edaravone were analyzed for the assessments of food effect on PK.||1.002|0.827|
72553834|NCT00272779|144639694|SUPERIORITY_OR_OTHER|||||||0.0058||95.0||||The explanatory variables in the model include treatment, genotype, time, and their interaction effects as fixed effects and the spatial exponential with respect to time from baseline was used to model the covariance structure of repeated measures.|linear mixed effect model|The FDR multiple testing adjustment was used to adjust p-values for the number of SNPs being tested (only SNPs with FDR-adj p-values \<0.2 reported)||Null Hypothesis: There is no association between the mean change from baseline in fasting triglycerides (phenotype) and the RETN\_097 genotypes. A single SNP association analysis was conducted using the linear mixed effect model for repeated measures (baseline, week 48 and 96) to test the overall genotype effect (i.e. an omnibus test on both the marginal genotype effect and the genotype-by-treatment interaction effect). Number of participants with RETN\_097 reported in Outcome Measure 16.||||0.0058
72553835|NCT00272779|144639695|SUPERIORITY_OR_OTHER|||||||0.0058||95.0||||The explanatory variables in the model include treatment, genotype, time, and their interaction effects as fixed effects and the spatial exponential with respect to time from baseline was used to model the covariance structure of repeated measures.|linear mixed effect model|The FDR multiple testing adjustment was used to adjust p-values for the number of SNPs being tested (only SNPs with FDR-adj p-values \<0.2 reported)||Null Hypothesis: There is no association between the mean change from baseline in fasting triglycerides (phenotype) and the RETN\_2265 genotypes. A single SNP association analysis was conducted using the linear mixed effect model for repeated measures (baseline, weeks 48 and 96) to test the overall genotype effect (i.e. an omnibus test on both the marginal genotype effect and the genotype-by-treatment interaction effect). Number of participants with RETN\_2265 reported in Outcome Measure 16.||||0.0058
72553836|NCT00272779|144639696|SUPERIORITY_OR_OTHER|||||||0.0253||95.0||||The explanatory variables in the model include treatment, genotype, time, and their interaction effects as fixed effects and the spatial exponential with respect to time from baseline was used to model the covariance structure of repeated measures.|linear mixed effect model|The FDR multiple testing adjustment was used to adjust p-values for the number of SNPs being tested (only SNPs with FDR-adj p-values \<0.2 reported)||Null Hypothesis: There is no association between the mean change from baseline in fasting triglycerides (phenotype) and the RETN\_598 genotypes. A single SNP association analysis was conducted using the linear mixed effect model for repeated measures (baseline, week 48 and 96) to test the overall genotype effect (i.e. an omnibus test on both the marginal genotype effect and the genotype-by-treatment interaction effect). Number of participants with RETN\_598 reported in Outcome Measure 16.||||0.0253
72553837|NCT00272779|144639697|SUPERIORITY_OR_OTHER|||||||0.1173||95.0||||The explanatory variables in the model include treatment, genotype, time, and their interaction effects as fixed effects and the spatial exponential with respect to time from baseline was used to model the covariance structure of repeated measures.|linear mixed effect model|The FDR multiple testing adjustment was used to adjust p-values for the number of SNPs being tested (only SNPs with FDR-adj p-values \<0.2 reported)||Null Hypothesis: There is no association between the mean change from baseline in fasting triglycerides (phenotype) and the APOE\_C130R genotypes. A single SNP association analysis was conducted using the linear mixed effect model for repeated measures (baseline, week 48 and 96) to test the overall genotype effect (i.e. an omnibus test on both the marginal genotype effect and the genotype-by-treatment interaction effect). Number of participants with APOE\_C130R reported in Outcome Measure 16.||||0.1173
72553838|NCT00272779|144639698|SUPERIORITY_OR_OTHER|||||||0.1173||95.0||||The explanatory variables in the model include treatment, genotype, time, and their interaction effects as fixed effects and the spatial exponential with respect to time from baseline was used to model the covariance structure of repeated measures.|linear mixed effect model|The FDR multiple testing adjustment was used to adjust p-values for the number of SNPs being tested (only SNPs with FDR-adj p-values \<0.2 reported)||Null Hypothesis: There is no association between the mean change from baseline in fasting triglycerides (phenotype) and the RETN\_734 genotypes. A single SNP association analysis was conducted using the linear mixed effect model for repeated measures (baseline, weeks 48 and 96) to test the overall genotype effect (i.e. an omnibus test on both the marginal genotype effect and the genotype-by-treatment interaction effect). Number of participants with RETN\_734 reported in Outcome Measure 16.||||0.1173
72553839|NCT00272779|144639699|SUPERIORITY_OR_OTHER|||||||0.1847||95.0||||The explanatory variables in the model include treatment, genotype, time, and their interaction effects as fixed effects and the spatial exponential with respect to time from baseline was used to model the covariance structure of repeated measures.|linear mixed effect model|The FDR multiple testing adjustment was used to adjust p-values for the number of SNPs being tested (only SNPs with FDR-adj p-values \<0.2 reported)||Null Hypothesis: There is no association between the mean change from baseline in fasting PAI-1 (phenotype) and the APOE\_R176C genotypes. A single SNP association analysis was conducted using the linear mixed effect model for repeated measures (baseline, weeks 48 and 96) to test the overall genotype effect (i.e. an omnibus test on both the marginal genotype effect and the genotype-by-treatment interaction effect). Number of participants with APOE\_R176C reported in Outcome Measure 16.||||0.1847
72553840|NCT00272779|144639700|SUPERIORITY_OR_OTHER|||||||0.1833||95.0||||The explanatory variables in the model include treatment, genotype, time, and their interaction effects as fixed effects and the spatial exponential with respect to time from baseline was used to model the covariance structure of repeated measures.|linear mixed effect model|The FDR multiple testing adjustment was used to adjust p-values for the number of SNPs being tested (only SNPs with FDR-adj p-values \<0.2 reported)||Null Hypothesis:There is no association between the mean change from baseline in fasting Tumor Necrosis Factor(TNF)-alpha (phenotype) and the IL6\_5309 genotypes. A single SNP association analysis was conducted using the linear mixed effect model for repeated measures (baseline, wk48 and 96) to test the overall genotype effect (ie. an omnibus test on both marginal genotype effect and the genotype-by-treatment interaction effect). Number of participants with IL6\_5309 reported in Outcome Measure 16||||0.1833
72553868|NCT05342597|144639788|OTHER|Estimated difference in least squares means and corresponding 90%CI of log-transformed PK parameters were back transformed to obtain the estimate and CI of the geometric mean ratio of each meal condition to the fasted state.|LS Mean Ratio|0.801|||||TWO_SIDED|90.0|0.712|0.901|||ANOVA|||PK parameters of unchanged edaravone were analyzed for the assessments of food effect on PK.||0.901|0.712|
72553841|NCT00272779|144639701|SUPERIORITY_OR_OTHER|||||||0.1833||95.0||||The explanatory variables in the model include treatment, genotype, time, and their interaction effects as fixed effects and the spatial exponential with respect to time from baseline was used to model the covariance structure of repeated measures.|linear mixed effect model|The FDR multiple testing adjustment was used to adjust p-values for the number of SNPs being tested (only SNPs with FDR-adj p-values \<0.2 reported)||Null Hypothesis: There is no association between the mean change from baseline in fasting TNF-alpha (phenotype) and the RS11030679 genotypes. A single SNP association analysis was conducted using the linear mixed effect model for repeated measures (baseline, week 48 and 96) to test the overall genotype effect (i.e. an omnibus test on both the marginal genotype effect and the genotype-by-treatment interaction effect). Number of participants with RETN\_097 reported in Outcome Measure 16.||||0.1833
72553842|NCT00272779|144639702|SUPERIORITY_OR_OTHER|||||||0.1694||95.0||||The explanatory variables in the model include treatment, genotype, time, and their interaction effects as fixed effects and the spatial exponential with respect to time from baseline was used to model the covariance structure of repeated measures.|linear mixed effect model|The FDR multiple testing adjustment was used to adjust p-values for the number of SNPs being tested (only SNPs with FDR-adj p-values \<0.2 reported)||Null Hypothesis: There is no association between the mean change from baseline in SAT-to-TAT Ratio (phenotype) and the CCDC122\_5980 genotypes. A single SNP association analysis was conducted using the linear mixed effect model for repeated measures (baseline, week 48 and 96) to test the overall genotype effect (i.e. an omnibus test on both the marginal genotype effect and the genotype-by-treatment interaction effect). Number of participants with CCDC122\_5980 reported in Outcome Measure 16.||||0.1694
72553843|NCT00272779|144639703|SUPERIORITY_OR_OTHER|||||||0.1335||95.0||||The explanatory variables in the model include treatment, genotype, time, and their interaction effects as fixed effects and the spatial exponential with respect to time from baseline was used to model the covariance structure of repeated measures.|linear mixed effect model|The FDR multiple testing adjustment was used to adjust p-values for the number of SNPs being tested (only SNPs with FDR-adj p-values \<0.2 reported)||Null Hypothesis: There is no association between the mean change from baseline in VAT (phenotype) and the BRUNOL\_1842 genotypes. A single SNP association analysis was conducted using the linear mixed effect model for repeated measures (baseline, week 48 and 96) to test the overall genotype effect (i.e. an omnibus test on both the marginal genotype effect and the genotype-by-treatment interaction effect). Number of participants with BRUNOL\_1842 reported in Outcome Measure 16.||||0.1335
72553844|NCT00272779|144639704|SUPERIORITY_OR_OTHER|||||||0.1335||95.0||||The explanatory variables in the model include treatment, genotype, time, and their interaction effects as fixed effects and the spatial exponential with respect to time from baseline was used to model the covariance structure of repeated measures.|linear mixed effect model|The FDR multiple testing adjustment was used to adjust p-values for the number of SNPs being tested (only SNPs with FDR-adj p-values \<0.2 reported)||Null Hypothesis: There is no association between the mean change from baseline in VAT (phenotype) and the RETN\_730 genotypes. A single SNP association analysis was conducted using the linear mixed effect model for repeated measures (baseline, weeks 48 and 96) to test the overall genotype effect (i.e. an omnibus test on both the marginal genotype effect and the genotype-by-treatment interaction effect). Number of participants with RETN\_730 reported in Outcome Measure 16.||||0.1335
72553845|NCT00272779|144639705|SUPERIORITY_OR_OTHER|||||||0.1696||95.0||||The explanatory variables in the model include treatment, genotype, time, and their interaction effects as fixed effects and the spatial exponential with respect to time from baseline was used to model the covariance structure of repeated measures.|linear mixed effect model|The FDR multiple testing adjustment was used to adjust p-values for the number of SNPs being tested (only SNPs with FDR-adj p-values \<0.2 reported)||Null Hypothesis: There is no association between the mean change from baseline in VAT-to-TAT Ratio (phenotype) and the CCDA122\_5980 genotypes. A single SNP association analysis was conducted using the linear mixed effect model for repeated measures (baseline, weeks 48 and 96) to test the overall genotype effect (i.e. an omnibus test on both the marginal genotype effect and the genotype-by-treatment interaction effect). Number of participants with CCDA122\_5980 reported in Outcome Measure 16.||||0.1696
72553846|NCT02440711|144639719|SUPERIORITY|||||||0.18||||||A significance threshold for all analyses was set at α=0.05. Bonferroni corrections for multiple comparisons were applied.|Multivariate regression|The multivariate regression included participants' biological masses and walking speeds as covariates.||Analysis of VO2 at slow walking speed||||.18
72553847|NCT02440711|144639719|SUPERIORITY|||||||0.21||||||A significance threshold for all analyses was set at α=0.05. Bonferroni corrections for multiple comparisons were applied.|Multivariate regression|The multivariate regression included participants' biological masses and walking speeds as covariates.||Analysis of VO2 at comfortable walking speed||||.21
72553848|NCT02440711|144639719|SUPERIORITY|||||||0.16||||||A significance threshold for all analyses was set at α=0.05. Bonferroni corrections for multiple comparisons were applied.|Multivariate regression|The multivariate regression included participants' biological masses and walking speeds as covariates.||Analysis of VO2 at fast walking speed||||.16
72553849|NCT02440711|144639721|SUPERIORITY|||||||0.29||||||Holm-Bonferroni adjustments for multiple comparisons were applied to yield an experiment-wise alpha level of .05.|t-test, 2 sided|||||||.29
72553850|NCT02440711|144639723|SUPERIORITY|||||||0.05||||||Holm-Bonferroni adjustments for multiple comparisons were applied to yield an experiment-wise alpha level of .05.|t-test, 2 sided|||||||0.05
72553851|NCT02440711|144639725|SUPERIORITY|||||||0.25||||||Holm-Bonferroni adjustments for multiple comparisons were applied to yield an experiment-wise alpha level of .05.|t-test, 2 sided|||||||.25
72553852|NCT02440711|144639727|SUPERIORITY|||||||0.86||||||Holm-Bonferroni adjustments for multiple comparisons were applied to yield an experiment-wise alpha level of .05.|t-test, 2 sided|||||||.86
72553853|NCT02440711|144639729|SUPERIORITY|||||||0.14||||||Holm-Bonferroni adjustments for multiple comparisons were applied to yield an experiment-wise alpha level of .05.|t-test, 2 sided|||Prosthetic side step length results||||.14
72553854|NCT02440711|144639729|SUPERIORITY||||||<|0.001||||||Holm-Bonferroni adjustments for multiple comparisons were applied to yield an experiment-wise alpha level of .05.|t-test, 2 sided|||Sound side step length results||||<0.001
72553855|NCT02440711|144639731|SUPERIORITY|||||||0.61||||||Holm-Bonferroni adjustments for multiple comparisons were applied to yield an experiment-wise alpha level of .05.|t-test, 2 sided|||Prosthetic side step time results||||.61
72553874|NCT00968812|144639818|NON_INFERIORITY_OR_EQUIVALENCE|Power calculation: assuming a difference between canagliflozin and glimepiride of 0.0% and a common standard deviation of 1.0%, and using a 2-sample, 1-sided t-test with a Type I error rate of 0.0125, and assuming a drop-out rate of 35% in 52 weeks, it was estimated that approximately 427 patients per group would provide 90% power to demonstrate non-inferiority with the non-inferiority margin of 0.3, comparing canagliflozin with glimepiride|Least-Squares Mean Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.05|||TWO_SIDED|95.0|-0.217|-0.023|||ANCOVA|||If the hypothesis of non-inferiority of canagliflozin to glimepiride at Week 52 was demonstrated (ie, upper bound of the 95% Confidence Interval of the treatment difference \[canagliflozin minus glimepiride\] was less than 0.3) and the upper bound was less than 0.0, the superiority of the canagliflozin dose relative to glimepiride would be concluded.||-0.023|-0.217|
72553875|NCT00968812|144639819|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.1|||<|0.001|TWO_SIDED|95.0|0.06|0.16|||Regression, Logistic|||||0.16|0.06|<0.001
72553876|NCT00968812|144639819|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.09|||<|0.001|TWO_SIDED|95.0|0.05|0.14|||Regression, Logistic|||||0.14|0.05|<0.001
72553877|NCT00968812|144639820|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-5.2|STANDARD_ERROR_OF_MEAN|0.3|<|0.001|TWO_SIDED|95.0|-5.7|-4.7|||ANCOVA|||||-4.7|-5.7|<0.001
72553878|NCT00968812|144639820|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-5.7|STANDARD_ERROR_OF_MEAN|0.3|<|0.001|TWO_SIDED|95.0|-6.2|-5.1|||ANCOVA|||||-5.1|-6.2|<0.001
72553879|NCT00968812|144639821|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.054|||TWO_SIDED|95.0|-0.2|0.01|||ANCOVA|||||0.010|-0.200|
72553880|NCT00968812|144639821|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.054|||TWO_SIDED|95.0|-0.289|-0.078|||ANCOVA|||||-0.078|-0.289|
72553881|NCT01593852|144639822|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Based on historical dose observations, a sample size of 68 patients per study group (i.e. 62 evaluable patients for 10% dropout rate) for a total of 136 patient randomized will allow for 80% power to detect for approximately 40% reduction in dose area product (DAP). This sample size will allow for detection of approximately 40% reduction in air kerma (AK). No adjustment for multiple endpoints was performed as both endpoints are assessing radiation dose.|||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
72553882|NCT01593852|144639830|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Based on historical dose observations, a sample size of 68 patients per study group (i.e. 62 evaluable patients for 10% dropout rate) for a total of 136 patient randomized will allow for 80% power to detect for approximately 40% reduction in dose area product (DAP). This sample size will allow for detection of approximately 40% reduction in air kerma (AK). No adjustment for multiple endpoints was performed as both endpoints are assessing radiation dose.|||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
72553883|NCT02937870|144639848|OTHER||Least square (LS) mean difference|0.66||||0.177|TWO_SIDED|95.0|-0.14|1.47||p-values for treatment comparison of test adhesive 1 vs. no adhesive were adjusted using the Dunnett's method.|ANCOVA|ANCOVA with factors for subject (random effect), period \& treatment, subject-level and period-level pre-treatment baseline bite force as covariate.|Difference is first-named treatment minus second-named treatment such that a positive difference favours the first named treatment.|||1.47|-0.14|0.1770
72553884|NCT02937870|144639849|OTHER||LS mean difference|-0.2||||0.8321|TWO_SIDED|95.0|-0.98|0.59||p-values for treatment comparison of test adhesive 1 vs. no adhesive were adjusted using the Dunnett's method.|ANCOVA|ANCOVA with factors for subject (random effect), period \& treatment, subject-level and period-level pre-treatment baseline bite force as covariate.|Difference is first-named treatment minus second-named treatment such that a positive difference favours the first named treatment.|||0.59|-0.98|0.8321
72553885|NCT02937870|144639850|OTHER||LS mean difference|0.07||||0.8566|TWO_SIDED|95.0|-0.72|0.87|||ANCOVA|ANCOVA with factors for subject (random effect), period \& treatment, subject-level and period-level pre-treatment baseline bite force as covariate.|Difference is first-named treatment minus second-named treatment such that a positive difference favours the first named treatment.|||0.87|-0.72|0.8566
72553886|NCT02937870|144639851|OTHER||LS mean difference|-0.79||||0.0488|TWO_SIDED|95.0|-1.58|0.0|||ANCOVA|ANCOVA with factors for subject (random effect), period \& treatment, subject-level and period-level pre-treatment baseline bite force as covariate.|Difference is first-named treatment minus second-named treatment such that a positive difference favours the first named treatment.|||-0.00|-1.58|0.0488
72553887|NCT02937870|144639852|OTHER||LS mean difference|0.86||||0.0352|TWO_SIDED|95.0|0.06|1.66|||ANCOVA|ANCOVA with factors for subject (random effect), period \& treatment, subject-level and period-level pre-treatment baseline bite force as covariate.|Difference is first-named treatment minus second-named treatment such that a positive difference favours the first named treatment.|||1.66|0.06|0.0352
72553888|NCT00609674|144639863|SUPERIORITY_OR_OTHER|||||||0.004|||||||ANCOVA|||||||0.004
72553889|NCT00571064|144639889|SUPERIORITY_OR_OTHER|||||||0.6593|TWO_SIDED|||||Significance level of 0.05|t-test, 2 sided|||Week 6 (Visit 3)||||0.6593
72553890|NCT00571064|144639889|SUPERIORITY_OR_OTHER|||||||0.6048|TWO_SIDED|||||Significance level of 0.05|t-test, 2 sided|||Week 12/ET (Visit 4)||||0.6048
72553891|NCT00571064|144639889|SUPERIORITY_OR_OTHER|||||||0.5924|TWO_SIDED|||||Significance level of 0.05|t-test, 2 sided|||Week 12 LOCF (Study Endpoint)||||0.5924
72553892|NCT00571064|144639890|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Significance level 0.05|t-test, 2 sided|||Week 6 (Visit 3)||||<0.0001
72553893|NCT00571064|144639890|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Significance level of 0.05|t-test, 2 sided|||Week 12/ET (Visit 4)||||<0.0001
72553894|NCT00571064|144639890|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Significance level of 0.05|t-test, 2 sided|||Week 12 LOCF (Study Endpoint)||||<0.0001
72553895|NCT00571064|144639892|SUPERIORITY_OR_OTHER|||||||0.0431|TWO_SIDED|||||Significance level of 0.05|t-test, 2 sided|||Week 12/ET (Visit 4)||||0.0431
72553896|NCT00571064|144639892|SUPERIORITY_OR_OTHER|||||||0.0431|TWO_SIDED|||||Significance level of 0.05|t-test, 2 sided|||Week 12 LOCF (Study Endpoint)||||0.0431
72553897|NCT00571064|144639894|SUPERIORITY_OR_OTHER|||||||0.1285|TWO_SIDED|||||Significance level of 0.05|t-test, 2 sided|||Week 12/ET (Visit 4)||||0.1285
72553898|NCT00571064|144639894|SUPERIORITY_OR_OTHER|||||||0.1285|TWO_SIDED|||||Significance level of 0.05|t-test, 2 sided|||Week 12 LOCF (Study Endpoint)||||0.1285
72553899|NCT00571064|144639896|SUPERIORITY_OR_OTHER|||||||0.2327|TWO_SIDED|||||Significance level of 0.05|t-test, 2 sided|||Week 6 (Visit 3)||||0.2327
72553900|NCT00571064|144639896|SUPERIORITY_OR_OTHER|||||||0.4724|TWO_SIDED|||||Significance level of 0.05|t-test, 2 sided|||Week 12/ET (Visit 4)||||0.4724
